,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,26516910,Menaquinone-7 Supplementation to Reduce Vascular Calcification in Patients with Coronary Artery Disease: Rationale and Study Protocol (VitaK-CAC Trial).,"Coronary artery calcification (CAC) develops early in the pathogenesis of atherosclerosis and is a strong and independent predictor of cardiovascular disease (CVD). Arterial calcification is caused by an imbalance in calcification regulatory mechanisms. An important inhibitor of calcification is vitamin K-dependent matrix Gla protein (MGP). Both preclinical and clinical studies have shown that inhibition of the vitamin K-cycle by vitamin K antagonists (VKA) results in elevated uncarboxylated MGP (ucMGP) and subsequently in extensive arterial calcification. This led us to hypothesize that vitamin K supplementation may slow down the progression of calcification. To test this, we designed the VitaK-CAC trial which analyses effects of menaquinone-7 (MK-7) supplementation on progression of CAC. The trial is a double-blind, randomized, placebo-controlled trial including patients with coronary artery disease (CAD). Patients with a baseline Agatston CAC-score between 50 and 400 will be randomized to an intervention-group (360 microgram MK-7) or a placebo group. Treatment duration will be 24 months. The primary endpoint is the difference in CAC-score progression between both groups. Secondary endpoints include changes in arterial structure and function, and associations with biomarkers. We hypothesize that treatment with MK-7 will slow down or arrest the progression of CAC and that this trial may lead to a treatment option for vascular calcification and subsequent CVD.",2015,Coronary artery calcification (CAC) develops early in the pathogenesis of atherosclerosis and is a strong and independent predictor of cardiovascular disease (CVD).,"['Patients with a baseline Agatston CAC-score between 50 and 400', 'patients with coronary artery disease (CAD', 'Patients with Coronary Artery Disease']","['placebo', 'Menaquinone-7 Supplementation', 'vitamin K antagonists (VKA', 'menaquinone-7 (MK-7) supplementation', 'vitamin K supplementation']","['CAC-score progression', 'progression of CAC', 'changes in arterial structure and function, and associations with biomarkers', 'Vascular Calcification']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0342649', 'cui_str': 'Vascular Calcinosis'}]",,0.432762,Coronary artery calcification (CAC) develops early in the pathogenesis of atherosclerosis and is a strong and independent predictor of cardiovascular disease (CVD).,"[{'ForeName': 'Liv M', 'Initials': 'LM', 'LastName': 'Vossen', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre (MUMC+), Maastricht 6229HX, The Netherlands. liv.vossen@mumc.nl.'}, {'ForeName': 'Leon J', 'Initials': 'LJ', 'LastName': 'Schurgers', 'Affiliation': 'Department of Biochemistry, Cardiovascular Research Institute Maastricht (CARIM), University of Maastricht, Maastricht 6229ER, The Netherlands. l.schurgers@maastrichtuniversity.nl.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'van Varik', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre (MUMC+), Maastricht 6229HX, The Netherlands. b.vanvarik@maastrichtuniversity.nl.'}, {'ForeName': 'Bas L J H', 'Initials': 'BL', 'LastName': 'Kietselaer', 'Affiliation': 'Departments of Cardiology and Radiology, Maastricht University Medical Centre (MUMC+), Maastricht 6229HX, The Netherlands. b.kietselaer@mumc.nl.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Vermeer', 'Affiliation': 'Group VitaK, Maastricht University, Maastricht 6229EV, The Netherlands. c.vermeer@vitak.com.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Meeder', 'Affiliation': 'Department of Cardiology, VieCuri Medical Centre, Venlo 5912 BL, The Netherlands. jmeeder@viecuri.nl.'}, {'ForeName': 'Braim M', 'Initials': 'BM', 'LastName': 'Rahel', 'Affiliation': 'Department of Cardiology, VieCuri Medical Centre, Venlo 5912 BL, The Netherlands. brahel@viecuri.nl.'}, {'ForeName': 'Yvonne J M', 'Initials': 'YJ', 'LastName': 'van Cauteren', 'Affiliation': 'Department of Cardiology, VieCuri Medical Centre, Venlo 5912 BL, The Netherlands. yvonne.cauteren@mumc.nl.'}, {'ForeName': 'Ge A', 'Initials': 'GA', 'LastName': 'Hoffland', 'Affiliation': 'Department of Radiology, VieCuri Medical Centre, Venlo 5912BL, The Netherlands. ghoffland@viecuri.nl.'}, {'ForeName': 'Roger J M W', 'Initials': 'RJ', 'LastName': 'Rennenberg', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre (MUMC+), Maastricht 6229HX, The Netherlands. r.rennenberg@mumc.nl.'}, {'ForeName': 'Koen D', 'Initials': 'KD', 'LastName': 'Reesink', 'Affiliation': 'Department of Biochemistry, Cardiovascular Research Institute Maastricht (CARIM), University of Maastricht, Maastricht 6229ER, The Netherlands. k.reesink@maastrichtuniversity.nl.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre (MUMC+), Maastricht 6229HX, The Netherlands. p.deleeuw@maastrichtuniversity.nl.'}, {'ForeName': 'Abraham A', 'Initials': 'AA', 'LastName': 'Kroon', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre (MUMC+), Maastricht 6229HX, The Netherlands. aa.kroon@mumc.nl.'}]",Nutrients,['10.3390/nu7115443']
1,32372651,"The effectiveness of Kinesio Taping ®  for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial.","OBJECTIVE


To evaluate the effectiveness of the Kinesio Taping ®  method for mobility and functioning improvement for patients with knee osteoarthritis (KO).
DESIGN


Randomized, double-blinded, controlled trial.
SETTING


Outpatient rehabilitation department.
SUBJECTS


A total of 187 subjects with symptomatic I-III grade KO participated; of these, 157 subjects were included in the analyses (intervention group,  n  = 81 (123 knees); control group,  n  = 76 (114 knees).
INTERVENTION


The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month.
MAIN MEASURES


Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants' experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was  p  < 0.05.
RESULTS


The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p  > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was -2.2 ± 3.2 seconds, at follow-up -2.4 ± 3.1 seconds; in control group -2.8 ± 3.6 seconds, and -2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p  > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16),  χ 2  = 7.5,  df  = 2,  p  = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p  < 0.005).
CONCLUSION


Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.",2020,"Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.","['knee osteoarthritis', 'Outpatient rehabilitation department', '187 subjects with symptomatic I-III grade KO participated; of these, 157 subjects were included in the analyses (intervention group,  n \u2009=\u200981 (123 knees); control group,  n\u2009 =\u200976 (114 knees', 'patients with knee osteoarthritis (KO']","['Kinesio Taping technique', 'Kinesio Taping ®', 'specific Kinesio Taping application, and the control group received non-specific knee taping for a month', 'Kinesio Taping ®  method']","['Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST', 'gait speed', 'subjective satisfaction', 'mobility and functioning improvement', 'knee flexion and enhancement in functioning assessed by KOOS', 'knee taping to symptom and mobility alleviation']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",187.0,0.0909194,"Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.","[{'ForeName': 'Venta', 'Initials': 'V', 'LastName': 'Donec', 'Affiliation': 'Department of Rehabilitation, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Rehabilitation, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Clinical rehabilitation,['10.1177/0269215520916859']
2,31377050,The effects of voice content on stress reactivity: A simulation paradigm of auditory verbal hallucinations.,"OBJECTIVES


Psychosis is associated with increased subjective and altered endocrine and autonomic nervous system stress-reactivity. Psychosis patients often experience auditory verbal hallucinations, with negative voice content being particularly associated with distress. The present study developed a voice-simulation paradigm and investigated the effect of simulated voices with neutral and negative content on psychophysiological stress-reactivity, and the effect of mindful voice-appraisals on stress-reactivity.
METHOD


Eighty-four healthy participants completed the Montreal Imaging Stress Task with simultaneous presentation of one of three randomly allocated auditory stimuli conditions: negative voices, neutral voices or non-voice ambient sounds. Subjective stress-levels and mindful voice-appraisals were assessed using questionnaire measures, and cortisol and α-amylase levels were measured using saliva samples.
RESULTS


ANOVA revealed a significant effect of condition on subjective stress-levels (p = .002), but not cortisol (p = .63) or α-amylase (p = .73). Post-hoc analyses showed that negative voices increased subjective stress-levels relative to neutral voices (p = .002) and ambient sounds (p = .01), which did not differ from each other (p = .41). Mindful voice-appraisals were associated with less distress across conditions (p = .003), although negative voices were also associated with less mindful appraisals (p < .001).
CONCLUSIONS


Negative voice content, rather than voices or auditory stimuli per se, is linked to greater subjective but not physiological stress-reactivity. Mindful appraisals may partially moderate this effect. These findings highlight the importance of voice content for the impact of voice-hearing, and highlight the potential value of mindfulness training to treat voice distress in psychosis.",2022,"Post-hoc analyses showed that negative voices increased subjective stress-levels relative to neutral voices (p = .002) and ambient sounds (p = .01), which did not differ from each other (p = .41).","['Psychosis patients often experience auditory verbal hallucinations, with negative voice content being particularly associated with distress', 'Eighty-four healthy participants completed the Montreal Imaging Stress Task with simultaneous presentation of one of three randomly allocated', 'auditory verbal hallucinations']","['auditory stimuli conditions: negative voices, neutral voices or non-voice ambient sounds']","['questionnaire measures, and cortisol and α-amylase levels', 'subjective stress-levels relative to neutral voices', 'subjective stress-levels', 'ambient sounds', 'Subjective stress-levels and mindful voice-appraisals', 'negative voices']","[{'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",84.0,0.0179829,"Post-hoc analyses showed that negative voices increased subjective stress-levels relative to neutral voices (p = .002) and ambient sounds (p = .01), which did not differ from each other (p = .41).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baumeister', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, Department of Psychology, London, UK; Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Germany. Electronic address: david.baumeister@kcl.ac.uk.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, Department of Psychology, London, UK; South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Beckenham, Kent, UK.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Pruessner', 'Affiliation': 'Department of Psychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Howes', 'Affiliation': ""South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Beckenham, Kent, UK; Institute of Psychiatry, Psychology & Neuroscience, King's College London, Department of Psychosis Studies, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chadwick', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, Department of Psychology, London, UK; Department of Psychology, University of Bath, Bath, UK.""}]",Schizophrenia research,['10.1016/j.schres.2019.07.019']
3,31743103,The effect of child-parent relationship therapy on social skills of Preschool Children: a semi-experimental study.,"BACKGROUND AND OBJECTIVE


Playing games for children is an instinct needed for ensuring happiness, it is a language for communication and self-expression, and a way to learn new things. Therefore, the present study aimed at evaluating the effectiveness of child-parent relationship therapy (CPRT) on the social skills of preschool children.
METHODS


An experimental study with a pretest-posttest design was conducted on 60 preschool children in Kordkuy City, Golestan Province, Iran in 2017 by using a simple random sampling method in both the experimental and control groups. Routine preschool education was performed in the control group and in the experimentalgroup it was done based on play therapy protocol in 10 sessions for 45-60 min. The social skills questionnaire authored by Gresham and Elliott was used as a data gathering tool. The data were analyzed by SPSS 16.
FINDINGS


An analysis of variance (ANOVA) test showed a significant difference between the scores of the experimental and control groups, which suggests that the CPRT model, a short-term plan of parental play therapy, can improve social skills in preschool children (p = 0/001).
CONCLUSION


Regarding the effectiveness of the CPRT, it is recommended that this method be used is an interactive-educational way in preschool centers of Iran.",2019,"Findings An analysis of variance (ANOVA) test showed a significant difference between the scores of the experimental and control groups, which suggests that the CPRT model, a short-term plan of parental play therapy, can improve social skills in preschool children (p = 0/001).","['preschool children', 'preschool centers of Iran', 'Preschool Children', '60 preschool children in Kordkuy City, Golestan Province, Iran in 2017 by using a simple random sampling method in both the experimental and control groups']","['CPRT', 'child-parent relationship therapy', 'child-parent relationship therapy (CPRT']","['social skills questionnaire', 'social skills']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}]",,0.0257938,"Findings An analysis of variance (ANOVA) test showed a significant difference between the scores of the experimental and control groups, which suggests that the CPRT model, a short-term plan of parental play therapy, can improve social skills in preschool children (p = 0/001).","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Hosseini', 'Affiliation': 'Department of Nursing, Aliabad Katoul Branch, Islamic Azad University, Aliabad Katoul, Iran.'}, {'ForeName': 'Golbahar', 'Initials': 'G', 'LastName': 'Akhoundzadeh', 'Affiliation': 'Department of Nursing, Aliabad Katoul Branch, Islamic Azad University, Aliabad Katoul, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Hojjati', 'Affiliation': 'Department of Nursing, Aliabad Katoul Branch, Islamic Azad University, Aliabad Katoul, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0151']
4,26875489,"Low-Dose Daily Intake of Vitamin K(2) (Menaquinone-7) Improves Osteocalcin γ-Carboxylation: A Double-Blind, Randomized Controlled Trials.","Vitamin K is essential for bone health, but the effects of low-dose vitamin K intake in Japanese subjects remain unclear. We investigated the effective minimum daily menaquinone-7 dose for improving osteocalcin γ-carboxylation. Study 1 was a double-blind, randomized controlled dose-finding trial; 60 postmenopausal women aged 50-69 y were allocated to one of four dosage group and consumed 0, 50, 100, or 200 μg menaquinone-7 daily for 4 wk, respectively, with a controlled diet in accordance with recommended daily intakes for 2010 in Japan. Study 2 was a double-blind, randomized placebo-controlled trial based on the results of Study 1; 120 subjects aged 20-69 y were allocated to the placebo or MK-7 group and consumed 0 or 100 μg menaquinone-7 daily for 12 wk, respectively. In both studies, circulating carboxylated osteocalcin and undercarboxylated osteocalcin were measured. The carboxylated osteocalcin/undercarboxylated osteocalcin ratio decreased significantly from baseline in the 0 μg menaquinone-7 group, in which subjects consumed the recommended daily intake of vitamin K with vitamin K1 and menaquinone-4 (Study 1). Menaquinone-7 increased the carboxylated osteocalcin/undercarboxylated osteocalcin ratio dose dependently, and significant effects were observed in both the 100 and 200 μg groups compared with the 0 μg group. Undercarboxylated osteocalcin concentrations decreased significantly, and the carboxylated osteocalcin/undercarboxylated osteocalcin ratio increased significantly in the 100 μg menaquinone-7 group compared with the placebo group (Study 2). Daily menaquinone-7 intake ≥100 μg was suggested to improve osteocalcin γ-carboxylation.",2015,"The carboxylated osteocalcin/undercarboxylated osteocalcin ratio decreased significantly from baseline in the 0 μg menaquinone-7 group, in which subjects consumed the recommended daily intake of vitamin K with vitamin K1 and menaquinone-4 (Study 1).","['120 subjects aged 20-69 y', 'Japanese subjects', '60 postmenopausal women aged 50-69 y']","['placebo or MK-7 group and consumed 0 or 100 μg menaquinone-7', 'placebo', 'Menaquinone-7', 'Vitamin K(2', 'Vitamin K']","['circulating carboxylated osteocalcin and undercarboxylated osteocalcin', 'Osteocalcin γ-Carboxylation', 'Undercarboxylated osteocalcin concentrations', 'carboxylated osteocalcin/undercarboxylated osteocalcin ratio', 'osteocalcin γ-carboxylation']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",60.0,0.594013,"The carboxylated osteocalcin/undercarboxylated osteocalcin ratio decreased significantly from baseline in the 0 μg menaquinone-7 group, in which subjects consumed the recommended daily intake of vitamin K with vitamin K1 and menaquinone-4 (Study 1).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Inaba', 'Affiliation': 'R&D Division, J-Oil Mills, Inc.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': ''}]",Journal of nutritional science and vitaminology,['10.3177/jnsv.61.471']
5,32282561,"Effects of Self-acupunctural Hand Massage Using Aromatic Oil on Alleviating the Stress, Fatigue, and Vital Signs of Korean Middle-Aged Women.","The study aimed to examine the effects of self-acupunctural hand massage using aromatic oil on the stress, fatigue, and vital signs of Korean middle-aged women. A quasi-experimental study using a pretest/posttest control group, nonsynchronized design was employed. The study participants consisted of 55 middle-aged women (27 in the experiment group and 28 in the control group), who visited a community center in Seoul, South Korea. Self-acupunctural hand massage using aromatic oil as an experimental intervention was performed once per day, 6 minutes per session for the left and right hands each, for 3 weeks. A questionnaire was designed to measure the general characteristics, stress, fatigue, and vital signs (blood pressure and pulse rate). There were significant differences in the degrees of stress, fatigue, and vital signs (blood pressure) between the 2 groups. Self-acupunctural hand massage using aromatic oil decreased the stress, fatigue, and vital signs (blood pressure) of Korean middle-aged women. Self-acupunctural hand massage using aromatic oil can be utilized as an effective nursing intervention for decreasing stress, fatigue, and vital signs (blood pressure) for middle-aged women in clinical practice.",2022,"There were significant differences in the degrees of stress, fatigue, and vital signs (blood pressure) between the 2 groups.","['middle-aged women in clinical practice', 'Korean Middle-Aged Women', '55 middle-aged women (27 in the experiment group and 28 in the control group), who visited a community center in Seoul, South Korea', 'Korean middle-aged women']","['Self-acupunctural hand massage using aromatic oil', 'Self-acupunctural Hand Massage Using Aromatic Oil', 'self-acupunctural hand massage using aromatic oil']","['Stress, Fatigue, and Vital Signs', 'general characteristics, stress, fatigue, and vital signs (blood pressure and pulse rate', 'degrees of stress, fatigue, and vital signs (blood pressure', 'stress, fatigue, and vital signs (blood pressure', 'stress, fatigue, and vital signs']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",55.0,0.0239057,"There were significant differences in the degrees of stress, fatigue, and vital signs (blood pressure) between the 2 groups.","[{'ForeName': 'Yi Kyun', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Complementary & Alternative Therapy Research Institute, Urimon Sarang, Seoul, Republic of Korea (Dr Park); Graduate School of Public Policy & Civic Engagement (Mss Kim and Hwang), Department of Nursing, Graduate School (Mss Gu and Yim), and College of Nursing Science (Dr Sok), Kyung Hee University, Seoul, Republic of Korea; and Department of Nursing, Shin Sung University, Chungchungnam-do, Republic of Korea (Dr Park).'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Min Kyung', 'Initials': 'MK', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'Myoung Hee', 'Initials': 'MH', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Hyon Shin', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Eunji', 'Initials': 'E', 'LastName': 'Yim', 'Affiliation': ''}, {'ForeName': 'Sohyune R', 'Initials': 'SR', 'LastName': 'Sok', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000373']
6,28166390,Emollients and moisturisers for eczema.,"BACKGROUND


Eczema is a chronic skin disease characterised by dry skin, intense itching, inflammatory skin lesions, and a considerable impact on quality of life. Moisturisation is an integral part of treatment, but it is unclear if moisturisers are effective.
OBJECTIVES


To assess the effects of moisturisers for eczema.
SEARCH METHODS


We searched the following databases to December 2015: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, the GREAT database. We searched five trials registers and checked references of included and excluded studies for further relevant trials.
SELECTION CRITERIA


Randomised controlled trials in people with eczema.
DATA COLLECTION AND ANALYSIS


We used standard Cochrane methodological procedures.
MAIN RESULTS


We included 77 studies (6603 participants, mean age: 18.6 years, mean duration: 6.7 weeks). We assessed 36 studies as at a high risk of bias, 34 at unclear risk, and seven at low risk. Twenty-four studies assessed our primary outcome 'participant-assessed disease severity', 13 assessed 'satisfaction', and 41 assessed 'adverse events'. Secondary outcomes included investigator-assessed disease severity (addressed in 65 studies), skin barrier function (29), flare prevention (16), quality of life (10), and corticosteroid use (eight). Adverse events reporting was limited (smarting, stinging, pruritus, erythema, folliculitis).Six studies evaluated moisturiser versus no moisturiser. 'Participant-assessed disease severity' and 'satisfaction' were not assessed. Moisturiser use yielded lower SCORAD than no moisturiser (three studies, 276 participants, mean difference (MD) -2.42, 95% confidence interval (CI) -4.55 to -0.28), but the minimal important difference (MID) (8.7) was unmet. There were fewer flares with moisturisers (two studies, 87 participants, RR 0.40, 95% CI 0.23 to 0.70), time to flare was prolonged (median: 180 versus 30 days), and less topical corticosteroids were needed (two studies, 222 participants, MD -9.30 g, 95% CI -15.3 to -3.27). There was no statistically significant difference in adverse events (one study, 173 participants, risk ratio (RR) 15.34, 95% CI 0.90 to 261.64). Evidence for these outcomes was low quality.With Atopiclair (three studies), 174/232 participants experienced improvement in participant-assessed disease severity versus 27/158 allocated to vehicle (RR 4.51, 95% CI 2.19 to 9.29). Atopiclair decreased itching (four studies, 396 participants, MD -2.65, 95% CI -4.21 to -1.09) and achieved more frequent satisfaction (two studies, 248 participants, RR 2.14, 95% CI 1.58 to 2.89), fewer flares (three studies, 397 participants, RR 0.18, 95% CI 0.11 to 0.31), and lower EASI (four studies, 426 participants, MD -4.0, 95% CI -5.42 to -2.57), but MID (6.6) was unmet. The number of participants reporting adverse events was not statistically different (four studies, 430 participants, RR 1.03, 95% CI 0.79 to 1.33). Evidence for these outcomes was moderate quality.Participants reported skin improvement more frequently with urea-containing cream than placebo (one study, 129 participants, RR 1.28, 95% CI 1.06 to 1.53; low-quality evidence), with equal satisfaction between the two groups (one study, 38 participants, low-quality evidence). Urea-containing cream improved dryness (investigator-assessed) more frequently (one study, 128 participants, RR 1.40, 95% CI 1.14 to 1.71; moderate-quality evidence) with fewer flares (one study, 44 participants, RR 0.47, 95% CI 0.24 to 0.92; low-quality evidence), but more participants in this group reported adverse events (one study, 129 participants, RR 1.65, 95% CI 1.16 to 2.34; moderate-quality evidence).Three studies assessed glycerol-containing moisturiser versus vehicle or placebo. More participants in the glycerol group noticed skin improvement (one study, 134 participants, RR 1.22, 95% CI 1.01 to 1.48; moderate-quality evidence), and this group saw improved investigator-assessed SCORAD (one study, 249 participants, MD -2.20, 95% CI -3.44 to -0.96; high-quality evidence), but MID was unmet. Participant satisfaction was not addressed. The number of participants reporting adverse events was not statistically significant (two studies, 385 participants, RR 0.90, 95% CI 0.68 to 1.19; moderate-quality evidence).Four studies investigated oat-containing moisturisers versus no treatment or vehicle. No significant differences between groups were reported for participant-assessed disease severity (one study, 50 participants, RR 1.11, 95% CI 0.84 to 1.46; low-quality evidence), satisfaction (one study, 50 participants, RR 1.06, 95% CI 0.74 to 1.52; very low-quality evidence), and investigator-assessed disease severity (three studies, 272 participants, standardised mean difference (SMD) -0.23, 95% CI -0.66 to 0.21; low-quality evidence). In the oat group, there were fewer flares (one study, 43 participants, RR 0.31, 95% CI 0.12 to 0.7; low-quality evidence) and less topical corticosteroids needed (two studies, 222 participants, MD -9.30g, 95% CI 15.3 to -3.27; low-quality evidence), but more adverse events were reported (one study, 173 participants; Peto odds ratio (OR) 7.26, 95% CI 1.76 to 29.92; low-quality evidence).All moisturisers above were compared to placebo, vehicle, or no moisturiser. Participants considered moisturisers more effective in reducing eczema (five studies, 572 participants, RR 2.46, 95% CI 1.16 to 5.23; low-quality evidence) and itch (seven studies, 749 participants, SMD -1.10, 95% CI -1.83 to -0.38) than control. Participants in both treatment arms reported comparable satisfaction (three studies, 296 participants, RR 1.35, 95% CI 0.77 to 2.26; low-quality evidence). Moisturisers led to lower investigator-assessed disease severity (12 studies, 1281 participants, SMD -1.04, 95% CI -1.57 to -0.51; high-quality evidence) and fewer flares (six studies, 607 participants, RR 0.33, 95% CI 0.17 to 0.62; moderate-quality evidence), but there was no difference in adverse events (10 studies, 1275 participants, RR 1.03, 95% CI 0.82 to 1.30; moderate-quality evidence).Topical active treatment combined with moisturiser was more effective than active treatment alone in reducing investigator-assessed disease severity (three studies, 192 participants, SMD -0.87, 95% CI -1.17 to -0.57; moderate-quality evidence) and flares (one study, 105 participants, RR 0.43, 95% CI 0.20 to 0.93), and was preferred by participants (both low-quality evidence). There was no statistically significant difference in number of adverse events (one study, 125 participants, RR 0.39, 95% CI 0.13 to 1.19; very low-quality evidence). Participant-assessed disease severity was not addressed.
AUTHORS' CONCLUSIONS


Most moisturisers showed some beneficial effects, producing better results when used with active treatment, prolonging time to flare, and reducing the number of flares and amount of topical corticosteroids needed to achieve similar reductions in eczema severity. We did not find reliable evidence that one moisturiser is better than another.",2017,"Participants considered moisturisers more effective in reducing eczema (five studies, 572 participants, RR 2.46, 95% CI 1.16 to 5.23; low-quality evidence) and itch (seven studies, 749 participants, SMD -1.10, 95% CI -1.83 to -0.38) than control.","['people with eczema', '77 studies (6603 participants, mean age: 18.6 years, mean duration: 6.7 weeks', '276 participants, mean difference (MD']",['placebo'],"['number of participants reporting adverse events', 'moderate-quality evidence', 'participant-assessed disease severity', 'adverse events', 'eczema', 'satisfaction', 'skin improvement', 'Atopiclair decreased itching', 'time to flare', 'frequent satisfaction', 'investigator-assessed disease severity (addressed in 65 studies), skin barrier function (29), flare prevention (16), quality of life (10), and corticosteroid use (eight', 'lower investigator-assessed disease severity', ""disease severity' and 'satisfaction"", 'Urea-containing cream improved dryness', 'flares', 'disease severity', 'investigator-assessed SCORAD', 'moderate-quality evidence) and flares', ""disease severity', 13 assessed 'satisfaction', and 41 assessed 'adverse events"", 'number of adverse events', 'investigator-assessed disease severity', 'low-quality evidence), satisfaction']","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1655278'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",173.0,0.517855,"Participants considered moisturisers more effective in reducing eczema (five studies, 572 participants, RR 2.46, 95% CI 1.16 to 5.23; low-quality evidence) and itch (seven studies, 749 participants, SMD -1.10, 95% CI -1.83 to -0.38) than control.","[{'ForeName': 'Esther J', 'Initials': 'EJ', 'LastName': 'van Zuuren', 'Affiliation': 'Department of Dermatology, Leiden University Medical Center, PO Box 9600, B1-Q, Leiden, Netherlands, 2300 RC.'}, {'ForeName': 'Zbys', 'Initials': 'Z', 'LastName': 'Fedorowicz', 'Affiliation': 'Bahrain Branch, Cochrane, Box 25438, Awali, Bahrain.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg og Frederiksberg, Nordre Fasanvej 57, Copenhagen, Denmark, DK-2000.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Lavrijsen', 'Affiliation': 'Department of Dermatology, Leiden University Medical Center, PO Box 9600, B1-Q, Leiden, Netherlands, 2300 RC.'}, {'ForeName': 'Bernd WM', 'Initials': 'BWM', 'LastName': 'Arents', 'Affiliation': 'Dutch Association for People with Atopic Dermatitis (VMCE: Vereniging voor Mensen met Constitutioneel Eczeem), PO Box 26, Nijkerk, Netherlands, NL-3860AA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012119.pub2']
7,32406808,Wheelchair backs that support the spinal curves: Assessing postural and functional changes.,"Objective:  To compare outcomes using a wheelchair back designed to support the natural seated spinal curves versus an upholstered back that promotes posterior pelvic tilt and thoracolumbar kyphosis. Design:  Cross-over intervention. Setting:  Two free-standing spinal cord injury (SCI) model system hospitals. Participants:  Fifty adults with motor complete SCI C6-T4, between the ages of 18-60 years who use a manual wheelchair for mobility were recruited from a convenience sample. Intervention:  Each participant's wheelchair back support was removed and replaced by an upholstered back and a solid back in randomized order. Postural and functional outcomes, pain, and satisfaction were evaluated using each back. Outcome measures:  Seated postural measurements included pelvic angle, spinal angle of kyphosis and linear measurement of spine. Functional outcomes included vertical forward reach, one stroke push, timed forward wheeling, ramp ascent and descent. Numerical pain rating and a satisfaction survey provided input pertaining to both backs. Results:  The solid back demonstrated significance in seated postural measurements. Participants using the solid back trended to higher scores in functional outcome measures including vertical forward reach, one stroke push and timed ramp ascent. Participants reported increased satisfaction with comfort and stability with the solid back. Conclusions:  This pilot study demonstrated that a wheelchair back, which supports the seated spinal curves improves upright posture, functional reach, and wheelchair propulsion skills. Further research is necessary to demonstrate statistical findings as well as to assess back height and lateral support.",2022,"Participants using the solid back trended to higher scores in functional outcome measures including vertical forward reach, one stroke push and timed ramp ascent.","['Participants:  Fifty adults with motor complete SCI C6-T4, between the ages of 18-60 years who use a manual wheelchair for mobility were recruited from a convenience sample']",['wheelchair back designed to support the natural seated spinal curves versus an upholstered back that promotes posterior pelvic tilt and thoracolumbar kyphosis'],"['Outcome measures:  Seated postural measurements included pelvic angle, spinal angle of kyphosis and linear measurement of spine', 'upright posture, functional reach, and wheelchair propulsion skills', 'Numerical pain rating', 'vertical forward reach, one stroke push, timed forward wheeling, ramp ascent and descent', 'Postural and functional outcomes, pain, and satisfaction', 'satisfaction with comfort and stability with the solid back', 'vertical forward reach, one stroke push and timed ramp ascent']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0184423', 'cui_str': 'Manual wheelchair'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205208', 'cui_str': 'Solid'}]",50.0,0.0664581,"Participants using the solid back trended to higher scores in functional outcome measures including vertical forward reach, one stroke push and timed ramp ascent.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Presperin Pedersen', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Craig Hospital, Denver, Colorado, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Dahlin', 'Affiliation': 'Craig Hospital, Denver, Colorado, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Henry', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Janell', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Craig Hospital, Denver, Colorado, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'McKenzie', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Sevigny', 'Affiliation': 'Craig Hospital, Denver, Colorado, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Yingling', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2020.1760530']
8,10421142,Preoperative microbiologic screening and antibiotic prophylaxis in pulmonary resection operations.,"BACKGROUND


Pulmonary resection is associated with considerable risk of infection, so antibiotic prophylaxis has become routine practice in pulmonary operations. We studied two standard flash antibiotic prophylaxis regimens and matched them to preoperatively acquired microorganisms.
METHODS


In 120 patients scheduled for elective pulmonary resection, aspirates were taken separately from the left and the right lung using a double-lumen tube. Then the patients received either 1.5 g of sulbactam plus ampicillin (n = 60; group 1) or 2 g of cefazolin (n = 60; group 2) intravenously as a single-shot antibiotic prophylaxis according to a prospective randomized sequence. When bacteria were found in the aspirates, both antibiotics were tested for susceptibility. The patients were monitored for the first 3 postoperative days with regard to bronchopulmonary infections.
RESULTS


Fifty-eight pathogens were isolated from the 120 patients. The cultured bacteria did not differ significantly between the two groups. In group 1 all found bacteria were susceptible to the used antibiotic prophylaxis, whereas in group 2 eight of the 25 found bacteria were not susceptible to antibiotic prophylaxis. Postoperatively, group 2 showed significantly more signs of bronchopulmonary infections than the group 1 and subsequently needed additional antibiotics more often. Intensive care unit stay was longer in patients of group 2 and costs were higher for these patients.
CONCLUSIONS


Preoperative microbiologic examination could be helpful to evaluate efficacy of the antibiotic prophylaxis regimen. Sulbactam plus ampicillin was significantly more effective than cefazolin.",1999,"Postoperatively, group 2 showed significantly more signs of bronchopulmonary infections than the group 1 and subsequently needed additional antibiotics more often.","['pulmonary resection operations', '120 patients scheduled for elective pulmonary resection, aspirates were taken separately from the left and the right lung using a double-lumen tube', 'Fifty-eight pathogens were isolated from the 120 patients']","['Preoperative microbiologic screening and antibiotic prophylaxis', 'Sulbactam plus ampicillin', 'sulbactam plus ampicillin', 'cefazolin']","['Intensive care unit stay', 'cultured bacteria', 'signs of bronchopulmonary infections']","[{'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0225706', 'cui_str': 'Right lung structure'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0948783', 'cui_str': 'Bronchopulmonary infection'}]",120.0,0.049675,"Postoperatively, group 2 showed significantly more signs of bronchopulmonary infections than the group 1 and subsequently needed additional antibiotics more often.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Klinikum der Stadt Ludwigshafen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Piper', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Uphus', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Füssle', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hempelmann', 'Affiliation': ''}]",The Annals of thoracic surgery,[]
9,30539540,Effects of essential amino acid supplementation and rehabilitation on functioning in hip fracture patients: a pilot randomized controlled trial.,"BACKGROUND


Physical exercise and nutrition seem to have a key role in the management of hip fracture patients.
AIM


To evaluate the impact of a 2-month rehabilitative protocol combined with dietetic counseling, with or without essential amino acid supplementation, on functioning in hip fracture patients.
METHODS


In this pilot randomized controlled study, we recruited patients aged more than 65 years, at 3 months after hip fracture. We randomly assigned the participants into two groups (A and B). Both groups performed a physical exercise rehabilitative programme (five sessions of 40 min/week for 2 weeks, followed by a home-based exercise protocol) and received a dietetic counseling; only group A was supplemented with two sachets of 4 g/day of essential amino acids (Aminotrofic ® ). We evaluated at baseline and after 2 months of intervention (T 1 ): hand grip strength, Timed Up and Go, and Iowa Level of Assistance scale (ILOA).
RESULTS


The 32 hip fracture patients (mean aged 79.03 ± 7.80 years) were allocated into two groups: group A (n = 16) and group B (n = 16). All the participants showed significant differences in all outcomes at T 1  (p < 0.017). Sarcopenic patients in group A (n = 10) showed statistically significant differences in all the primary outcomes at T 1  (p < 0.017), whereas sarcopenic patients in group B (n = 13) showed a significant reduction of ILOA only. In non-sarcopenic patients, we found no differences at T 1  in all outcome measures.
DISCUSSION


Hip fractures are a complex multifactorial condition of the elderly that determines devastating effects on functioning and independence.
CONCLUSION


A multidisciplinary rehabilitative and nutritional intervention seems to be effective on functioning in hip fracture patients, in particular sarcopenic ones.",2019,All the participants showed significant differences in all outcomes at T 1  (p < 0.017).,"['recruited patients aged more than 65 years, at 3\xa0months after hip fracture', 'hip fracture patients', '32 hip fracture patients (mean aged 79.03\u2009±\u20097.80\xa0years']","['rehabilitative protocol combined with dietetic counseling, with or without essential amino acid supplementation', 'multidisciplinary rehabilitative and nutritional intervention', 'essential amino acid supplementation and rehabilitation', 'physical exercise rehabilitative programme (five sessions of 40\xa0min/week for 2\xa0weeks, followed by a home-based exercise protocol) and received a dietetic counseling; only group A was supplemented with two sachets of 4\xa0g/day of essential amino acids (Aminotrofic ® ']","['grip strength, Timed Up and Go, and Iowa Level of Assistance scale (ILOA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522003', 'cui_str': 'Age more than 65 years (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation (product)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4319662', 'cui_str': 'Sachet'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0222045'}]",,0.0726432,All the participants showed significant differences in all outcomes at T 1  (p < 0.017).,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Invernizzi', 'Affiliation': ""Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont, Viale Piazza D'Armi, 1, 28100, Novara, Italy. marco.invernizzi@med.uniupo.it.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'de Sire', 'Affiliation': ""Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont, Viale Piazza D'Armi, 1, 28100, Novara, Italy.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': ""D'Andrea"", 'Affiliation': 'Clinical Nutrition Unit, University Hospital ""Maggiore della Carità"", Novara, Italy.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Carrera', 'Affiliation': 'Clinical Nutrition Unit, University Hospital ""Maggiore della Carità"", Novara, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Renò', 'Affiliation': 'Innovative Research Laboratory for Wound Healing, Department of Health Sciences, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Migliaccio', 'Affiliation': 'Section of Health Sciences, Department of Movement, Human and Health Sciences, University ""Foro Italico"", Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Iolascon', 'Affiliation': 'Department of Medical and Surgical Specialties and Dentistry, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cisari', 'Affiliation': ""Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont, Viale Piazza D'Armi, 1, 28100, Novara, Italy.""}]",Aging clinical and experimental research,['10.1007/s40520-018-1090-y']
10,30565191,Effects of interval walking training compared to normal walking training on cognitive function and arterial function in older adults: a randomized controlled trial.,"PURPOSE


This study investigated whether interval walking training (IWT) improves cognitive function and arterial function in older adults.
METHODS


A total of 68 older adults registered in clinical trials (mean age ± standard deviation, 70 ± 4 years) were randomly assigned to two groups: one group performed IWT (n = 34), and the other performed normal walking training (NWT, n = 34). Participants in the IWT group performed five or more sets of low-intensity walking (duration: 3 min per set; peak aerobic capacity for walking: 40%) followed by high-intensity walking (duration: 3 min per set; peak aerobic capacity for walking: > 70%). The NWT group walked at approximately 50% of the peak aerobic capacity for walking. The IWT and NWT were performed for 20 weeks. Trail making test-A and B and carotid-femoral pulse wave velocity (cfPWV) were measured in both groups at baseline and again at the end of the 20-week study period.
RESULTS


Compared to baseline, time for trail making test-A (IWT group: P = 0.00004, NWT group: P = 0.000006) and B (IWT group: P = 0.03, NWT group: P = 0.003) as well as cfPWV (IWT group: P = 0.000002, NWT group: P = 0.03) decreased significantly after the 20-week study period in both groups. However, cfPWV in the IWT group decreased significantly more than that in the NWT group (P = 0.03).
CONCLUSION


These results suggested that although both IWT and NWT were similarly effective at improving cognitive function, IWT reduced central arterial stiffness more than NWT.",2019,"Compared to baseline, time for trail making test-A (IWT group: P = 0.00004, NWT group: P = 0.000006) and B (IWT group: P = 0.03, NWT group: P = 0.003) as well as cfPWV (IWT group: P = 0.000002, NWT group: P = 0.03) decreased significantly after the 20-week study period in both groups.","['68 older adults registered in clinical trials (mean age\u2009±\u2009standard deviation, 70\u2009±\u20094\xa0years', 'older adults']","['normal walking training', 'NWT', 'low-intensity walking (duration: 3\xa0min per set; peak aerobic capacity for walking: 40%) followed by high-intensity walking (duration: 3\xa0min per set; peak aerobic capacity for walking: >\u200970', 'interval walking training', 'interval walking training (IWT']","['Trail making test-A and B and carotid-femoral pulse wave velocity (cfPWV', 'cognitive function and arterial function', 'cfPWV', 'cognitive function, IWT reduced central arterial stiffness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}]",68.0,0.0347053,"Compared to baseline, time for trail making test-A (IWT group: P = 0.00004, NWT group: P = 0.000006) and B (IWT group: P = 0.03, NWT group: P = 0.003) as well as cfPWV (IWT group: P = 0.000002, NWT group: P = 0.03) decreased significantly after the 20-week study period in both groups.","[{'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University, 7-1-1, Fukasawa, Setagaya-ku, Tokyo, 158-8508, Japan. tokamoto@nittai.ac.jp.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University, 7-1-1, Fukasawa, Setagaya-ku, Tokyo, 158-8508, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Fundamental Education, Teikyo University of Science, Tokyo, Japan.'}]",Aging clinical and experimental research,['10.1007/s40520-018-1093-8']
11,31525156,The effect of positive thinking training on the quality of life of parents of adolescent with thalassemia.,"INTRODUCTION


Thalassemia, as the most common chronic hereditary blood disorder in humans, can impose many adverse effects on parents and their affected children. On the other hand, positive thinking is the method or the result of a positive focus on a constructive issue, so by teaching positive thinking, we can improve physical and social function, and promote emotional health and overall quality of life. The aim of this study was to determine the effect of positive thinking training on the quality of life of parents of adolescents with thalassemia.
METHODS


This quasi-experimental study was performed on 52 parents of adolescents with thalassemia who attended Taleghani Hospital in Golestan province, Iran in 2017. Samples were randomly assigned into two groups of intervention and control. The positive thinking training (based on the theory of Martin Seligman) was carried out in the intervention group in 10 (45-60 min) sessions over a 5-week period. Data collection tools in this study were the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF) and a demographic information questionnaire. Data were analyzed by SPSS-16 software using independent t-test, the paired t-test and a covariance test.
RESULTS


The results of paired t-test showed a significant difference in the score of quality of life in intervention group before and after the intervention (p < 0.001). However, this test did not show any significant difference in the control group (p = 0.11). The covariance test, after removing the pre-test score, showed a significant difference between the intervention and control groups in terms of the score of quality of life, so that 13% of the changes after the intervention were due to the intervention (p = 0.009, η = 0.13).
CONCLUSION


The positive thinking training increased the quality of life of parents of adolescents with thalassemia. Therefore, using this program can be an effective way of improving the quality of life of parents. Thus, positive thinking training is suggested to be used as an effective strategy for increasing the quality of life of parents with ill children.",2019,"The covariance test, after removing the pre-test score, showed a significant difference between the intervention and control groups in terms of the score of quality of life, so that 13% of the changes after the intervention were due to the intervention (p = 0.009, η = 0.13).","['52 parents of adolescents with thalassemia who attended Taleghani Hospital in Golestan province, Iran in 2017', 'parents of adolescent with thalassemia', 'parents with ill children', 'parents of adolescents with thalassemia']",['positive thinking training'],"['score of quality of life', 'quality of life of parents of adolescents with thalassemia', 'World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF', 'quality of life']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C4280069', 'cui_str': 'Positive Thinking'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",52.0,0.0300041,"The covariance test, after removing the pre-test score, showed a significant difference between the intervention and control groups in terms of the score of quality of life, so that 13% of the changes after the intervention were due to the intervention (p = 0.009, η = 0.13).","[{'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Sadeghloo', 'Affiliation': 'Young Researchers and Elite Club, Aliabad Katoul Branch, Islamic Azad University, Aliabad Katoul, Iran.'}, {'ForeName': 'Parna', 'Initials': 'P', 'LastName': 'Shamsaee', 'Affiliation': 'Department of Nursing, Ali Abad Kotoul Branch, Islamic Azad University, Ali Abad Kotoul, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Hesari', 'Affiliation': 'Department of Nursing, Ali Abad Kotoul Branch, Islamic Azad University, Ali Abad Kotoul, Iran.'}, {'ForeName': 'Golbanhar', 'Initials': 'G', 'LastName': 'Akhondzadeh', 'Affiliation': 'Department of Nursing, Ali Abad Kotoul Branch, Islamic Azad University, Ali Abad Kotoul, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Hojjati', 'Affiliation': 'Department of Nursing, Ali Abad Kotoul Branch, Islamic Azad University, Ali Abad Kotoul, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0159']
12,28952607,Vitamin K-induced effects on body fat and weight: results from a 3-year vitamin K2 intervention study.,"BACKGROUND/OBJECTIVES


Vitamin K status has been linked to fat and glucose metabolism by several authors, but whether high vitamin K intake influences body weight or composition has remained unclear. Here we tested the hypothesis that increased vitamin K intake decreases body fat or fat distribution.
SUBJECTS/METHODS


In a randomized placebo-controlled human intervention trial, 214 postmenopausal women, 55-65 years of age, received either 180 mcg/day of vitamin K2 (menaquinone-7, MK-7) or placebo for 3 years. Osteocalcin (OC) carboxylation was used as a marker for vitamin K status, and fat distribution was assessed by dual-energy X-ray absorptiometry total body scan.
RESULTS


In the total cohort, MK-7 supplementation increased circulating carboxylated OC (cOC) but had no effect on body composition. In those with an above-median response in OC carboxylation ('good responders'), MK-7 treatment resulted in a significant increase in total and human molecular weight adiponectin and a decrease in abdominal fat mass and in the estimated visceral adipose tissue area compared with the placebo group and the poor responders.
CONCLUSIONS


The fact that changes in body composition measures or markers for fat or glucose metabolism were not associated with changes in uncarboxylated OC (ucOC) does not support the assumption that ucOC stimulates fat metabolism in humans. Instead, high vitamin K2 intake may support reducing body weight, abdominal and visceral fat, notably in subjects showing a strong increase in cOC. A causal relation between the changes in cOC and body fat or distribution cannot be concluded from these data.",2018,"In the total cohort, MK-7 supplementation increased circulating carboxylated OC (cOC) but had no effect on body composition.","['214 postmenopausal women, 55-65 years of age']","['placebo', '180\u2009mcg/day of vitamin K2 (menaquinone-7, MK-7) or placebo', 'vitamin K intake', 'MK-7 supplementation', 'Vitamin K']","['circulating carboxylated OC (cOC', 'Osteocalcin (OC) carboxylation', 'body composition', 'body weight, abdominal and visceral fat', 'total and human molecular weight adiponectin', 'abdominal fat mass', 'body fat and weight']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",214.0,0.110955,"In the total cohort, MK-7 supplementation increased circulating carboxylated OC (cOC) but had no effect on body composition.","[{'ForeName': 'M H J', 'Initials': 'MHJ', 'LastName': 'Knapen', 'Affiliation': 'R&D Group VitaK, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Jardon', 'Affiliation': 'R&D Group VitaK, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vermeer', 'Affiliation': 'R&D Group VitaK, Maastricht University, Maastricht, The Netherlands.'}]",European journal of clinical nutrition,['10.1038/ejcn.2017.146']
13,32318809,A phase I study of the effect of repeated oral doses of pantoprazole on the pharmacokinetics of a single dose of fedratinib in healthy male subjects.,"PURPOSE


Fedratinib, an oral, selective Janus kinase 2 inhibitor with activity against both wild-type and mutant Janus kinase 2, has pH-dependent solubility, with free solubility at pH 1. Concomitant administration of drugs that reduce gastric acid secretion, such as pantoprazole, may decrease the absorption of fedratinib and affect patient outcomes. The aim of this study was to evaluate the impact of 7-day repeated 40-mg doses of pantoprazole on the pharmacokinetic (PK) properties of a single 500-mg dose of fedratinib in healthy male subjects.
METHODS


In this phase I, single-center, open-label, two-period, two-treatment, fixed-sequence crossover study, healthy male subjects were administered a single dose of fedratinib 500 mg on day 1 in Period 1, followed by pantoprazole 40 mg daily for 7 days (day 1 to day 7) and a single dose of fedratinib 500 mg on day 7 in Period 2. After the discontinuation of nine subjects due to vomiting, the protocol was amended to provide ondansetron as antiemetic prophylaxis to an additional ten enrolled subjects.
RESULTS


Twenty-six subjects were included. Repeated doses of pantoprazole 40 mg resulted in clinically insignificant increases in fedratinib exposure. Maximum plasma concentration increased by 1.09-fold and area under the plasma concentration-time curve from time 0 to infinity increased by 1.15-fold. All treatment-emergent adverse events were mild or moderate, except for one instance of neutropenia, which was considered unrelated to study intervention.
CONCLUSION


Coadministration with pantoprazole did not have clinically meaningful effects on fedratinib PK. No new or unexpected safety signals were observed with fedratinib.",2020,"All treatment-emergent adverse events were mild or moderate, except for one instance of neutropenia, which was considered unrelated to study intervention.
","['healthy male subjects', 'Twenty-six subjects were included']","['pantoprazole', 'ondansetron', 'fedratinib 500\xa0mg on day 1 in Period 1, followed by pantoprazole']","['Maximum plasma concentration', 'gastric acid secretion', 'fedratinib exposure']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232552', 'cui_str': 'Gastric acid secretion'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",26.0,0.144717,"All treatment-emergent adverse events were mild or moderate, except for one instance of neutropenia, which was considered unrelated to study intervention.
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Altasciences/Vince and Associates, Overland Park, KS, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA. gopal.krishna@bms.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04074-4']
14,30982092,Home-based rehabilitation in inoperable non-small cell lung cancer-the patient experience.,"PURPOSE


Exercise is important in lung cancer, yet most people do not meet the physical activity guidelines. The aim of this study was to characterise the views and experiences of participants with inoperable lung cancer who completed a home-based rehabilitation program.
METHODS


Ninety-two participants were recruited (45 intervention group [IG], 47 usual care). Individual semi-structured interviews were conducted with participants randomised to the IG of a trial of home-based exercise, behaviour change and symptom management. Data were independently coded by two researchers, cross-checked and analysed using content analysis with a summary of arising themes.
RESULTS


Of the IG (25/45), 55% were interviewed: mean (SD) age 67 (13) years; male 52%; disease stage n (%) III = 9 (36), IV = 11 (44); radical treatment intent n (%) 13 (52). The majority of participants reported program benefits, both in the physical domain (reduced sedentary time and improved strength, fitness and function) and the mental domain (motivation to keep healthy, preventing boredom). Support to self-manage symptoms was well received and many participants reported increased confidence in managing their symptoms. Exercise enablers included having expert health professional support; motivation to be stronger and better prepared for future challenges; and having an achievable and familiar program that was monitored. Treatment side-effects, pain from comorbidities and the weather were exercise barriers. For the majority of participants the use of a Fitbit™ activity tracker, text message exercise reminders and an exercise diary helped to promote adherence.
CONCLUSIONS


This home-based rehabilitation program was acceptable to most participants with multiple benefits reported including improved fitness, motivation and ability to manage symptoms.",2020,"The majority of participants reported program benefits, both in the physical domain (reduced sedentary time and improved strength, fitness and function) and the mental domain (motivation to keep healthy, preventing boredom).","['Ninety-two participants were recruited (45 intervention group [IG], 47 usual care', 'SD) age 67 (13) years; male 52%; disease stage n (%) III\u2009=\u20099 (36), IV\u2009=\u200911 (44); radical treatment intent n (%) 13 (52', ' 55% were interviewed: mean', 'participants with inoperable lung cancer who completed a home-based rehabilitation program']",['Home-based rehabilitation'],"['fitness, motivation and ability to manage symptoms', 'sedentary time and improved strength, fitness and function) and the mental domain (motivation to keep healthy, preventing boredom']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0006019', 'cui_str': 'Boredoms'}]",92.0,0.0594039,"The majority of participants reported program benefits, both in the physical domain (reduced sedentary time and improved strength, fitness and function) and the mental domain (motivation to keep healthy, preventing boredom).","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Edbrooke', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia. larae@unimelb.edu.au.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Denehy', 'Affiliation': 'Allied Health Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Granger', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Kapp', 'Affiliation': 'Department of Nursing, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sanchia', 'Initials': 'S', 'LastName': 'Aranda', 'Affiliation': 'Department of Nursing, The University of Melbourne, Melbourne, Victoria, Australia.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04783-4']
15,28745999,Trial of Tocilizumab in Giant-Cell Arteritis.,"BACKGROUND


Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis.
METHODS


In this 1-year trial, we randomly assigned 251 patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26-week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52-week prednisone taper. Dosing of prednisone and safety were also assessed.
RESULTS


Sustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26-week prednisone taper and 18% of those in the placebo group that underwent the 52-week prednisone taper (P<0.001 for the comparisons of either active treatment with placebo). The cumulative median prednisone dose over the 52-week period was 1862 mg in each tocilizumab group, as compared with 3296 mg in the placebo group that underwent the 26-week taper (P<0.001 for both comparisons) and 3818 mg in the placebo group that underwent the 52-week taper (P<0.001 for both comparisons). Serious adverse events occurred in 15% of the patients in the group that received tocilizumab weekly, 14% of those in the group that received tocilizumab every other week, 22% of those in the placebo group that underwent the 26-week taper, and 25% of those in the placebo group that underwent the 52-week taper. Anterior ischemic optic neuropathy developed in one patient in the group that received tocilizumab every other week.
CONCLUSIONS


Tocilizumab, received weekly or every other week, combined with a 26-week prednisone taper was superior to either 26-week or 52-week prednisone tapering plus placebo with regard to sustained glucocorticoid-free remission in patients with giant-cell arteritis. Longer follow-up is necessary to determine the durability of remission and safety of tocilizumab. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT01791153 .).",2017,The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper.,"['patients with giant-cell arteritis', 'Giant-Cell Arteritis']","['tocilizumab', 'placebo', 'prednisone tapering plus placebo', 'Tocilizumab', 'interleukin-6 receptor alpha inhibitor tocilizumab', 'prednisone', 'prednisone taper, or placebo combined with a prednisone taper', 'subcutaneous tocilizumab']","['Anterior ischemic optic neuropathy', 'Sustained remission', 'cumulative median prednisone dose', 'rate of remission', 'rates of relapse', 'rate of sustained glucocorticoid-free remission', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039483', 'cui_str': 'Horton Disease'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0677026', 'cui_str': 'interleukin-6R alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0751711', 'cui_str': 'Anterior Ischemic Optic Neuropathy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",251.0,0.386125,The primary outcome was the rate of sustained glucocorticoid-free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26-week prednisone taper.,"[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Tuckwell', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dimonaco', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Micki', 'Initials': 'M', 'LastName': 'Klearman', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Aringer', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Blockmans', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Brouwer', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Cid', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Dasgupta', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Rech', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Salvarani', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schett', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Unizony', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Collinson', 'Affiliation': ""From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.); the Department of Rheumatology, Medicine III, University Medical Center and Faculty of Medicine Technische Universität Dresden, Dresden (M.A.), Friedrich-Alexander-University Erlangen-Nürnberg, Department of Internal Medicine 3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology (G.S.), Universitätsklinikum Erlangen, Erlangen, and the Division of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich (H.S.-K.) - all in Germany; the Department of General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine, Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio Emilia and Università di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and Hospital for Special Surgery, New York (R.S.).""}]",The New England journal of medicine,['10.1056/NEJMoa1613849']
16,27854117,Treatment of neonates with respiratory distress syndrome by proportional assist ventilation plus synchronized intermittent mandatory ventilation: a comparison study.,"BACKGROUND


The proportion assisted ventilation (PAV) can improve patient-ventilator interaction, reducing the incidence of end-expiratory asynchrony and increasing the time of synchrony. PAV could compensate for the leaks by elastic and resistive unloading and thus is ideal for neonates with uncuffed airways. The aim of this study was to compare the relevant clinical parameters of neonates with respiratory distress syndrome (RDS) who are supported by PAV plus synchronized intermittent mandatory ventilation (SIMV) and SIMV.
METHODS


Forty-six neonates diagnosed as RDS who required mechanical ventilation were randomly divided into observer group (support by PAV+SIMV mode, N.=23) and control group (support by SIMV mode, N.=23). The X-ray grading situation, the number of asynchrony-delayed trigger, mean arterial blood pressure (MABP), spontaneous respiratory rate (RR), heart rate (HR), blood gas analysis values and circulation and respiratory parameters at each timepoint after 30 minutes, 12, 24, 48 and 72 hours of mechanical ventilation were observed.
RESULTS


The forty-four neonates in two groups have been cured, the other 2 neonates (one in each group) gave up treatment and automatically discharged. There were no statistically significant differences in male, gestational age, body weight, duration of mechanical ventilation, oxygen dependence and hospital stay between the two groups (all P>0.05). There were no statistically significant differences in MABP, HR and ratio of arterial-to-alveolar partial pressure of oxygen (a/APO<inf>2</inf>) at each time point after mechanical ventilation between the two groups(all P>0.05). The number of asynchrony-delayed trigger in observer group was lower than that in control group, the difference was statistically significant (P<0.05). The number of spontaneous RR in observer group was higher than that in control group. The difference was statistically significant (P<0.05).
CONCLUSIONS


The PAV plus SIMV shows a good clinical effect in treatment of neonates with RDS. It could be better to use neonatal spontaneous breathing and might cause less damage to the lung than SIMV mode.",2022,"There were no statistically significant differences in MABP , HR and ratio of arterial-to-alveolar partial pressure of oxygen (a/APO2) at each time point after mechanical ventilation between the two groups(all P>0.05).","['neonates with respiratory distress syndrome', '46 neonates daignozed as RDS who required mechanical ventilation', 'neonates with respiratory distress syndrome(RDS', 'neonates with uncuffed airways', 'neonates with RDS']","['proportional assist ventilation plus synchronized intermittent mandatory ventilation', 'proportion assisted ventilation (PAV', 'PAV plus synchronized intermittent mandatory ventilation (SIMV) and SIMV']","['number of spontaneous RR', 'MABP , HR and ratio of arterial-to-alveolar partial pressure of oxygen (a/APO2', 'mean arterial blood pressure (MABP), spontaneous respiratory rate(RR), heart rate(HR), blood gas analysis values and circulation and respiratory parameters', 'male, gestational age, body weight, The duration of mechanical ventilation, oxygen dependence and hospital stay', 'number of asynchrony- delayed trigger']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}]","[{'cui': 'C3178855', 'cui_str': 'Proportional Assist Ventilation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0278335', 'cui_str': 'Synchronized intermittent mandatory ventilation (procedure)'}, {'cui': 'C0554804', 'cui_str': 'Ventilation assistance'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0425486', 'cui_str': 'Rate of spontaneous respiration (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]",46.0,0.0243599,"There were no statistically significant differences in MABP , HR and ratio of arterial-to-alveolar partial pressure of oxygen (a/APO2) at each time point after mechanical ventilation between the two groups(all P>0.05).","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': ""Yangzhou University Medical College, Neonatal Medical Center, Huai'an Maternity and Child Healthcare Hospital, Huai'an, China - wr618@163.com.""}, {'ForeName': 'Zhao-Fang', 'Initials': 'ZF', 'LastName': 'Tian', 'Affiliation': ""Department of Neonatology, Huai'an First People's Hospital, Nanjing Medical University, Huai'an, China.""}, {'ForeName': 'Xiang-Yong', 'Initials': 'XY', 'LastName': 'Kong', 'Affiliation': ""Department of Neonatology, Bayi Children's Hospital Affiliated to Army General Hospital, Beijing, China.""}, {'ForeName': 'Shao-Dong', 'Initials': 'SD', 'LastName': 'Hua', 'Affiliation': ""Department of Neonatology, Bayi Children's Hospital Affiliated to Army General Hospital, Beijing, China.""}, {'ForeName': 'Jin-Hui', 'Initials': 'JH', 'LastName': 'Hu', 'Affiliation': ""Yangzhou University Medical College, Neonatal Medical Center, Huai'an Maternity and Child Healthcare Hospital, Huai'an, China.""}, {'ForeName': 'Guo-Fang', 'Initials': 'GF', 'LastName': 'Zhen', 'Affiliation': ""Yangzhou University Medical College, Neonatal Medical Center, Huai'an Maternity and Child Healthcare Hospital, Huai'an, China.""}]",Minerva pediatrics,['10.23736/S2724-5276.16.04658-2']
17,31387121,"The effect of menaquinone-7 supplementation on vascular calcification in patients with diabetes: a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Vitamin K occurs in the diet as phylloquinone and menaquinones. Observational studies have shown that both phylloquinone and menaquinone intake might reduce cardiovascular disease (CVD) risk. However, the effect of vitamin K on vascular calcification is unknown.
OBJECTIVES


The aim of this study was to assess if menaquinone supplementation, compared to placebo, decreases vascular calcification in people with type 2 diabetes and known CVD.
METHODS


In this double-blind, randomized, placebo-controlled trial, we randomly assigned men and women with type 2 diabetes and CVD to 360 µg/d menaquinone-7 (MK-7) or placebo for 6 mo. Femoral arterial calcification at baseline and 6 mo was measured with 18sodium fluoride positron emission tomography (18F-NaF PET) scans as target-to-background ratios (TBRs), a promising technique to detect active calcification. Calcification mass on conventional computed tomography (CT) scan was measured as secondary outcome. Dephosphorylated-uncarboxylated matrix Gla protein (dp-ucMGP) concentrations were measured to assess compliance. Linear regression analyses were performed with either TBR or CT calcification at follow-up as the dependent variable, and treatment and baseline TBR or CT calcification as independent variables.
RESULTS


We randomly assigned 35 patients to the MK-7 group (33 completed follow-up) and 33 to the placebo group (27 completed follow-up). After the 6-mo intervention, TBR tended to increase in the MK-7 group compared with placebo (0.25; 95% CI: -0.02, 0.51; P = 0.06), although this was not significant. Log-transformed CT calcification mass did not increase in the intervention group compared with placebo (0.50; 95% CI: -0.23, 1.36; P = 0.18). MK-7 supplementation significantly reduced dp-ucMGP compared with placebo (-205.6 pmol/L; 95% CI: -255.8, -155.3 pmol/L). No adverse events were reported.
CONCLUSION


MK-7 supplementation tended to increase active calcification measured with 18F-NaF PET activity compared with placebo, but no effect was found on conventional CT. Additional research investigating the interpretation of 18F-NaF PET activity is necessary. This trial was registered at clinicaltrials.gov as NCT02839044.",2019,"MK-7 supplementation significantly reduced dp-ucMGP compared with placebo (-205.6 pmol/L; 95% CI: -255.8, -155.3 pmol/L).","['randomly assigned men and women with type 2 diabetes and CVD to 360 µg/d menaquinone-7 (MK-7) or placebo for 6 mo', 'people with type 2 diabetes and known CVD', 'patients with diabetes']","['phylloquinone and menaquinone intake', '18sodium fluoride positron emission tomography (18F-NaF PET) scans', 'MK-7 supplementation', 'MK-7', 'menaquinone-7 supplementation', 'placebo', 'menaquinone supplementation', 'vitamin K', 'Dephosphorylated-uncarboxylated matrix Gla protein (dp-ucMGP']","['TBR', 'Log-transformed CT calcification mass', 'active calcification', 'Calcification mass on conventional computed tomography (CT) scan', 'Femoral arterial calcification', 'adverse events', 'vascular calcification', 'cardiovascular disease (CVD) risk']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0031862', 'cui_str': 'phytonadione'}, {'cui': 'C0086605', 'cui_str': 'Vitamin K 2'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0441633'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0065752', 'cui_str': 'matrix gamma-carboxyglutamic acid protein'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0342649', 'cui_str': 'Vascular Calcinosis'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",35.0,0.803547,"MK-7 supplementation significantly reduced dp-ucMGP compared with placebo (-205.6 pmol/L; 95% CI: -255.8, -155.3 pmol/L).","[{'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Zwakenberg', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'de Jong', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Bartstra', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van Asperen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Westerink', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'de Valk', 'Affiliation': 'Department of Endocrinology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'R H J A', 'Initials': 'RHJA', 'LastName': 'Slart', 'Affiliation': 'Medical Imaging Center, Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Luurtsema', 'Affiliation': 'Medical Imaging Center, Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Wolterink', 'Affiliation': 'Image Sciences Institute, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'de Borst', 'Affiliation': 'Department of Vascular Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'van Herwaarden', 'Affiliation': 'Department of Vascular Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'van de Ree', 'Affiliation': 'Department of Internal Medicine, Diakonessenhuis, Utrecht, Netherlands.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Schurgers', 'Affiliation': 'Department of Biochemistry, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'J W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz147']
18,30821824,"Factors Associated With Acute Pain Estimation, Postoperative Pain Resolution, Opioid Cessation, and Recovery: Secondary Analysis of a Randomized Clinical Trial.","Importance


Acute postoperative pain is associated with the development of persistent postsurgical pain, but it is unclear which aspect is most estimable.
Objective


To identify patient clusters based on acute pain trajectories, preoperative psychosocial characteristics associated with the high-risk cluster, and the best acute pain predictor of remote outcomes.
Design, Setting, and Participants


A secondary analysis of the Stanford Accelerated Recovery Trial randomized, double-blind clinical trial was conducted at a single-center, tertiary, referral teaching hospital. A total of 422 participants scheduled for thoracotomy, video-assisted thoracoscopic surgery, total hip replacement, total knee replacement, mastectomy, breast lumpectomy, hand surgery, carpal tunnel surgery, knee arthroscopy, shoulder arthroplasty, or shoulder arthroscopy were enrolled between May 25, 2010, and July 25, 2014. Data analysis was performed from January 1 to August 1, 2018.
Interventions


Patients were randomized to receive gabapentin (1200 mg, preoperatively, and 600 mg, 3 times a day postoperatively) or active placebo (lorazepam, 0.5 mg preoperatively, inactive placebo postoperatively) for 72 hours.
Main Outcomes and Measures


A modified Brief Pain Inventory prospectively captured 3 surgical site pain outcomes: average pain and worst pain intensity over the past 24 hours, and current pain intensity. Within each category, acute pain trajectories (first 10 postoperative pain scores) were compared using a k-means clustering algorithm. Fifteen descriptors of acute pain were compared as predictors of remote postoperative pain resolution, opioid cessation, and full recovery.
Results


Of the 422 patients enrolled, 371 patients (≤10% missing pain scores) were included in the analysis. Of these, 146 (39.4%) were men; mean (SD) age was 56.67 (11.70) years. Two clusters were identified within each trajectory category. The high pain cluster of the average pain trajectory significantly predicted prolonged pain (hazard ratio [HR], 0.63; 95% CI, 0.50-0.80; P < .001) and delayed opioid cessation (HR, 0.52; 95% CI, 0.41-0.67; P < .001) but was not a predictor of time to recovery in Cox proportional hazards regression (HR, 0.89; 95% CI, 0.69-1.14; P = .89). Preoperative risk factors for categorization to the high average pain cluster included female sex (adjusted relative risk [ARR], 1.36; 95% CI, 1.08-1.70; P = .008), elevated preoperative pain (ARR, 1.11; 95% CI, 1.07-1.15; P < .001), a history of alcohol or drug abuse treatment (ARR, 1.90; 95% CI, 1.42-2.53; P < .001), and receiving active placebo (ARR, 1.27; 95% CI, 1.03-1.56; P = .03). Worst pain reported on postoperative day 10 was the best predictor of time to pain resolution (HR, 0.83; 95% CI, 0.78-0.87; P < .001), opioid cessation (HR, 0.84; 95% CI, 0.80-0.89; P < .001), and complete surgical recovery (HR, 0.91; 95% CI, 0.86-0.96; P < .001).
Conclusions and Relevance


This study has shown a possible uniform predictor of remote postoperative pain, opioid use, and recovery that can be easily assessed. Future work is needed to replicate these findings.
Trial Registration


ClinicalTrials.gov Identifier: NCT01067144.",2019,"The high pain cluster of the average pain trajectory significantly predicted prolonged pain (hazard ratio [HR], 0.63; 95% CI, 0.50-0.80; P < .001) and delayed opioid cessation (HR, 0.52; 95% CI, 0.41-0.67; P < .001) but was not a predictor of time to recovery in Cox proportional hazards regression (HR, 0.89; 95% CI, 0.69-1.14; P = .89).","['422 patients enrolled, 371 patients (≤10% missing pain scores', ' hand surgery, carpal tunnel surgery, knee arthroscopy, shoulder arthroplasty, or shoulder arthroscopy were enrolled between May 25, 2010, and July 25, 2014', '146 (39.4%) were men; mean (SD) age was 56.67 (11.70) years', '422 participants scheduled for']","['gabapentin', 'thoracotomy, video-assisted thoracoscopic surgery, total hip replacement, total knee replacement, mastectomy, breast lumpectomy', 'active placebo (lorazepam, 0.5 mg preoperatively, inactive placebo']","['acute pain trajectories', 'history of alcohol or drug abuse treatment', 'prolonged pain', 'Main Outcomes and Measures\n\n\nA modified Brief Pain Inventory prospectively captured 3 surgical site pain outcomes: average pain and worst pain intensity over the past 24 hours, and current pain intensity', 'delayed opioid cessation', 'Acute Pain Estimation, Postoperative Pain Resolution, Opioid Cessation, and Recovery', 'time to pain resolution', 'acute pain', 'opioid cessation', 'complete surgical recovery', 'elevated preoperative pain', 'remote postoperative pain resolution, opioid cessation, and full recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0559702', 'cui_str': 'Arthroscopy of shoulder'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0851238', 'cui_str': 'Tylectomy (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}]",422.0,0.746742,"The high pain cluster of the average pain trajectory significantly predicted prolonged pain (hazard ratio [HR], 0.63; 95% CI, 0.50-0.80; P < .001) and delayed opioid cessation (HR, 0.52; 95% CI, 0.41-0.67; P < .001) but was not a predictor of time to recovery in Cox proportional hazards regression (HR, 0.89; 95% CI, 0.69-1.14; P = .89).","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Hah', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, Palo Alto, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cramer', 'Affiliation': 'Stanford Systems Neuroscience and Pain Lab, Stanford University, Palo Alto, California.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hilmoe', 'Affiliation': 'Stanford Systems Neuroscience and Pain Lab, Stanford University, Palo Alto, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmidt', 'Affiliation': 'Stanford Systems Neuroscience and Pain Lab, Stanford University, Palo Alto, California.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McCue', 'Affiliation': 'Stanford Systems Neuroscience and Pain Lab, Stanford University, Palo Alto, California.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Trafton', 'Affiliation': 'Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, California.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Clay', 'Affiliation': 'Stanford Systems Neuroscience and Pain Lab, Stanford University, Palo Alto, California.'}, {'ForeName': 'Yasamin', 'Initials': 'Y', 'LastName': 'Sharifzadeh', 'Affiliation': 'Stanford Systems Neuroscience and Pain Lab, Stanford University, Palo Alto, California.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Ruchelli', 'Affiliation': 'Stanford Systems Neuroscience and Pain Lab, Stanford University, Palo Alto, California.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Redwood City, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Huddleston', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Palo Alto, California.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Maloney', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Palo Alto, California.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Dirbas', 'Affiliation': 'Department of General Surgery, Stanford University, Palo Alto, California.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shrager', 'Affiliation': 'Cardiothoracic Surgery, Division of Thoracic Surgery, Stanford University, Palo Alto, California.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Costouros', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Palo Alto, California.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Curtin', 'Affiliation': 'Division of Hand and Plastic Surgery, Department of Orthopaedic Surgery, Stanford University, Palo Alto, California.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Mackey', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, Palo Alto, California.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Carroll', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, Palo Alto, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.0168']
19,31526276,Implementation of the FIFA 11+ Injury Prevention Program by High School Athletic Teams Did Not Reduce Lower Extremity Injuries: A Cluster Randomized Controlled Trial.,"BACKGROUND


Lower extremity injuries are common in high school sports and are costly, and some have poor outcomes. The FIFA 11+ injury prevention program has been shown to decrease injuries in elite athletes by up to 72%.
HYPOTHESIS


High schools in which coaches implement the FIFA 11+ injury prevention program in their athletic programs will have a decreased incidence of lower extremity injuries compared with schools using their usual prepractice warm-up.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


Fourteen high schools that employed an athletic trainer were randomly assigned to either the FIFA 11+ group or control group (usual warm-up routine). Exposure to sports and injuries were recorded and used to determine the incidence rates of lower extremity injuries per athlete-exposure (AE). The FIFA 11+ program was implemented by coaches and complicance with the program recorded.
RESULTS


There were 196 lower extremity injuries among 1825 athletes in the FIFA 11+ group and 172 injuries among 1786 athletes in the control group (1.59 and 1.47 injuries per 1000 AEs, respectively;  P  = .771). The distribution of the types of injury in the 2 groups did not differ, but the body locations where the injuries occurred differed somewhat ( P  = .051). The FIFA 11+ group had larger proportions of thigh and foot injuries, while the control group had higher proportions of knee and ankle injuries. Group differences in injury rates varied with sport ( P  = .041 for interaction), but there were no significant differences in injury rates between the FIFA 11+ and control groups by sport, level of play, and sex. In the FIFA 11+ group, 62% of the coaches reported that their teams completed the full FIFA 11+ program at least once a week, and 32% reported that they completed it at least twice a week.
CONCLUSION


This study did not demonstrate a reduction in lower extremity injuries in schools randomized to use the FIFA 11+ program compared with schools using their usual prepractice warm-up program. Coach-reported compliance with performing the FIFA 11+ program at least twice a week was low.",2019,"Group differences in injury rates varied with sport ( P  = .041 for interaction), but there were no significant differences in injury rates between the FIFA 11+ and control groups by sport, level of play, and sex.",['Fourteen high schools that employed an athletic trainer'],"['FIFA 11+ Injury Prevention Program', 'FIFA 11+ group or control group (usual warm-up routine']","['Extremity Injuries', 'larger proportions of thigh and foot injuries', 'injury rates', 'proportions of knee and ankle injuries', 'extremity injuries']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0149697', 'cui_str': 'Foot Injuries'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0085111', 'cui_str': 'Ankle Injuries'}]",196.0,0.0275468,"Group differences in injury rates varied with sport ( P  = .041 for interaction), but there were no significant differences in injury rates between the FIFA 11+ and control groups by sport, level of play, and sex.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Slauterbeck', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Choquette', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Tourville', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Mickey', 'Initials': 'M', 'LastName': 'Krug', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bert R', 'Initials': 'BR', 'LastName': 'Mandelbaum', 'Affiliation': 'Cedars-Sinai Kerlan-Jobe Institute, Santa Monica, California, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Vacek', 'Affiliation': 'Department of Medical Biostatistics, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Beynnon', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Robert Larner, MD, College of Medicine, University of Vermont, Burlington, Vermont, USA.'}]",The American journal of sports medicine,['10.1177/0363546519873270']
20,31418073,Effects of relaxation on self-esteem of patients with cancer: a randomized clinical trial.,"BACKGROUND AND OBJECTIVES


Cancer is usually associated with decreased self-esteem. Relaxation is one of the most effective methods to promote self-esteem of patients with chronic diseases. Hence, the present study aimed to investigate the effects of relaxation on self-esteem of patients with cancer.
METHODS


This randomized clinical trial was conducted on 80 patients with cancer. The samples were selected by convenience sampling method and were randomly divided into experimental and control groups. In the experimental group, the patients implemented relaxation techniques once a day for 30 min during 60 consecutive days in addition to receiving routine care, while patients in the control group received only routine care. Before and after the intervention, the Persian version of the Coopersmith Self-Esteem Inventory (CSEI) was completed.
RESULTS


After the interventions, significant differences were observed between groups in favor of the relaxation group in total score of CSEI and all its subscales (P = 0.0001). In the experimental group, a significant increase in total score and all subscales of CSEI was observed after the intervention (P = 0.001), whereas in the control group, a significant decrease was found in all dimensions (P = 0.001).
CONCLUSION


The relaxation seems to be potentially effective in promoting self-esteem of patients with cancer. Further studies, particularly randomized clinical trials with higher sample size and more power, are needed to confirm the obtained findings.",2020,"After the interventions, significant differences were observed between groups in favor of the relaxation group in total score of CSEI and all its subscales (P = 0.0001).","['80 patients with cancer', 'patients with cancer', 'patients with chronic diseases']","['control group received only routine care', 'relaxation']","['total score and all subscales of CSEI', 'Persian version of the Coopersmith Self-Esteem Inventory (CSEI', 'total score of CSEI', 'self-esteem']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",60.0,0.0354296,"After the interventions, significant differences were observed between groups in favor of the relaxation group in total score of CSEI and all its subscales (P = 0.0001).","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Noruzi Zamenjani', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Golitaleb', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Zahedi', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jadidi', 'Affiliation': 'Chronic Diseases (Home Care) Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. Masoud.Rezaei68@yahoo.com.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05025-3']
21,31585096,MAVRIC: a multicenter randomized controlled trial of transabdominal vs transvaginal cervical cerclage.,"BACKGROUND


Vaginal cerclage (a suture around the cervix) commonly is placed in women with recurrent pregnancy loss. These women may experience late miscarriage or extreme preterm delivery, despite being treated with cerclage. Transabdominal cerclage has been advocated after failed cerclage, although its efficacy is unproved by randomized controlled trial.
OBJECTIVE


The objective of this study was to compare transabdominal cerclage or high vaginal cerclage with low vaginal cerclage in women with a history of failed cerclage. Our primary outcome was delivery at <32 completed weeks of pregnancy.
STUDY DESIGN


This was a multicenter randomized controlled trial. Women were assigned randomly (1:1:1) to receive transabdominal cerclage, high vaginal cerclage, or low vaginal cerclage either before conception or at <14 weeks of gestation.
RESULTS


The data for 111 of 139 women who were recruited and who conceived were analyzed: 39 had transabdominal cerclage; 39 had high vaginal cerclage, and 33 had low vaginal cerclage. Rates of preterm birth at <32 weeks of gestation were significantly lower in women who received transabdominal cerclage compared with low vaginal cerclage (8% [3/39] vs 33% [11/33]; relative risk, 0.23; 95% confidence interval, 0.07-0.76; P=.0157). The number needed to treat to prevent 1 preterm birth was 3.9 (95% confidence interval, 2.32-12.1). There was no difference in preterm birth rates between high and low vaginal cerclage (38% [15/39] vs 33% [11/33]; relative risk, 1.15; 95% confidence interval, 0.62-2.16; P=.81). No neonatal deaths occurred. In an exploratory analysis, women with transabdominal cerclage had fewer fetal losses compared with low vaginal cerclage (3% [1/39] vs 21% [7/33]; relative risk, 0.12; 95% confidence interval, 0.016-0.93; P=.02). The number needed to treat to prevent 1 fetal loss was 5.3 (95% confidence interval, 2.9-26).
CONCLUSION


Transabdominal cerclage is the treatment of choice for women with failed vaginal cerclage. It is superior to low vaginal cerclage in the reduction of risk of early preterm birth and fetal loss in women with previous failed vaginal cerclage. High vaginal cerclage does not confer this benefit. The numbers needed to treat are sufficiently low to justify transabdominal surgery and cesarean delivery required in this select cohort.",2020,"Rates of preterm birth <32 weeks were significantly lower in women who received transabdominal cerclage compared to low vaginal cerclage [8% (3/39) v 38% (15/39), RR 0.23 (95% CI 0.07 to 0.76), p=0.0078].","['111/139 women recruited who conceived were analysed: 39 to transabdominal cerclage, 39 to high vaginal cerclage and 33 to low vaginal cerclage', 'women with a history of failed cerclage', 'women with failed vaginal cerclage', 'women with recurrent pregnancy loss', 'women with previous failed vaginal cerclage']","['Vaginal cerclage (a suture around the cervix', 'MAVRIC', 'transabdominal cerclage', 'Transabdominal Versus Transvaginal Cervical Cerclage', 'low vaginal cerclage', ""transabdominal cerclage, high vaginal cerclage or low vaginal cerclage, either prior to conception or before 14 weeks' gestation"", 'transabdominal cerclage or high vaginal cerclage to low vaginal cerclage', 'Transabdominal cerclage']","['Rates of preterm birth', 'preterm birth', 'preterm birth rates', 'fetal loss', 'fetal losses', 'neonatal deaths', 'risk of early preterm birth and fetal loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C2921106', 'cui_str': 'Recurrent pregnancy loss'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C3853999', 'cui_str': 'Cervical cerclage (physical object)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",,0.348487,"Rates of preterm birth <32 weeks were significantly lower in women who received transabdominal cerclage compared to low vaginal cerclage [8% (3/39) v 38% (15/39), RR 0.23 (95% CI 0.07 to 0.76), p=0.0078].","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK. Electronic address: Andrew.shennan@kcl.ac.uk.""}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Chandiramani', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Bennett', 'Affiliation': 'Parturition Research Group, Institute of Reproductive and Development Biology, Imperial College London, London, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'David', 'Affiliation': ""UCL EGA Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Girling', 'Affiliation': 'Department of Obstetrics and Gynaecology, West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, Middlesex, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ridout', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Simpson', 'Affiliation': ""Department of Women's and Children's Health, University of Leeds, Leeds, UK.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Thornton', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Tydeman', 'Affiliation': 'Forth Park Hospital, Fife Hayfield House, Kirkcaldy, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Quenby', 'Affiliation': 'Division of Biomedical Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.09.040']
22,31037378,Minocycline for symptom reduction during radiation therapy for head and neck cancer: a randomized clinical trial.,"PURPOSE


Local/systemic symptoms during cancer therapy may be exacerbated by dysregulated inflammation and its downstream toxic effects. Minocycline can suppress proinflammatory cytokine release; therefore, we investigated its potential to reduce patient-reported symptom severity during radiotherapy (RT) for head and neck cancer (HNC).
METHODS


Eligible patients for this blinded, placebo-controlled trial were adults with T0-3, N-any, and M0 HNC receiving single-modality RT. Participants were randomized 1:1 to either minocycline (200 mg/day) or placebo during RT. The primary endpoint was the area under the curve (AUC) of 5 prespecified symptoms (pain, fatigue, disturbed sleep, poor appetite, difficulty swallowing/chewing) during RT, assessed with the MD Anderson Symptom Inventory for HNC (MDASI-HN).
RESULTS


We analyzed data from 20 evaluable patients per arm. Overall, 75% had oropharyngeal cancer and 78% were male. No grade 3+ adverse events potentially related to study medication were observed. Two minocycline patients required a feeding tube during RT vs 5 placebo patients (P = 0.21). The average daily AUC during RT for the 5 MDASI-HN symptoms was 3.1 (SD = 1.0) for minocycline and 3.7 (SD = 1.7) for placebo (P = 0.16); the 0.37 effect size was less than our 0.70 target. AUC comparisons for several individual symptoms and symptom interference favored minocycline but were not statistically significant. The greatest numerical differences occurred for systemic symptoms, larger toward treatment end, and in early post-RT recovery.
CONCLUSIONS


Minocycline was feasible, well tolerated, and achieved a positive signal toward reducing patient-reported symptom severity during RT for HNC, particularly for systemic symptoms. This justifies additional study and informs future trial design.",2020,Two minocycline patients required a feeding tube during RT vs 5 placebo patients (P = 0.21).,"['head and neck cancer', '20 evaluable patients per arm', 'Eligible patients for this blinded, placebo-controlled trial were adults with T0-3, N-any, and M0 HNC receiving single-modality RT']","['Minocycline', 'placebo', 'minocycline', 'radiation therapy']","['average daily AUC', 'area under the curve (AUC) of 5 prespecified symptoms (pain, fatigue, disturbed sleep, poor appetite, difficulty swallowing/chewing) during RT, assessed with the MD Anderson Symptom Inventory for HNC (MDASI-HN', 'oropharyngeal cancer']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}]",,0.376019,Two minocycline patients required a feeding tube during RT vs 5 placebo patients (P = 0.21).,"[{'ForeName': 'G Brandon', 'Initials': 'GB', 'LastName': 'Gunn', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 97, Houston, TX, 77030, USA. gbgunn@mdanderson.org.'}, {'ForeName': 'Tito R', 'Initials': 'TR', 'LastName': 'Mendoza', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Garden', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 97, Houston, TX, 77030, USA.'}, {'ForeName': 'Xin Shelley', 'Initials': 'XS', 'LastName': 'Wang', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Morrison', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 97, Houston, TX, 77030, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Frank', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 97, Houston, TX, 77030, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Phan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 97, Houston, TX, 77030, USA.'}, {'ForeName': 'Clifton D', 'Initials': 'CD', 'LastName': 'Fuller', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 97, Houston, TX, 77030, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Chambers', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ehab Y', 'Initials': 'EY', 'LastName': 'Hanna', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Thoracic/Head & Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 97, Houston, TX, 77030, USA.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Cleeland', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04791-4']
23,30519976,The Finnish Interprofessional Medication Assessment (FIMA): baseline findings from home care setting.,"PURPOSE


Medication-related problems and declined functional capacity are closely associated factors among older people. The purpose of this study is to describe the procedure of interprofessional medication assessment in home care context and the baseline characteristics of the study population.
METHODS


The FIMA study was a randomized, controlled intervention study comparing general practitioner-led interprofessional medication assessment and usual care. Patients' chronic diagnoses and medication use as well as physical and cognitive functions were investigated. Performance in daily activities, use of care services and help from family and relatives, self-rated health and health-related quality of life, and adverse effects commonly related to medication were assessed.
RESULTS


The home care patients (n = 512) had significant disease burden and functional limitations. The mean number of all medicines was 15 and that of regularly taken medicines 10. The majority of patients (87%) had excessive polypharmacy. The most commonly used (97%) ATC medicine class was nervous system medicines. Clinically relevant (class C or D SFINX record) drug-drug interactions were seen in 74% of the patients. The most frequent risks of adverse effects were risk of bleeding (66%), constipation (58%) and orthostatism (54%) occurring in over half of the patients. Medicines affecting renal function were used by 85% of the patients.
CONCLUSIONS


There is an evident need and justification for medication assessments in home care. In most cases, home care patients fulfill the criteria for regular medication assessments.",2019,"The most frequent risks of adverse effects were risk of bleeding (66%), constipation (58%) and orthostatism (54%) occurring in over half of the patients.",['older people'],['general practitioner-led interprofessional medication assessment and usual care'],"['Performance in daily activities, use of care services and help from family and relatives, self-rated health and health-related quality of life', 'disease burden and functional limitations', 'excessive polypharmacy', 'constipation', 'renal function', 'mean number of all medicines']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]",,0.0316727,"The most frequent risks of adverse effects were risk of bleeding (66%), constipation (58%) and orthostatism (54%) occurring in over half of the patients.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Auvinen', 'Affiliation': 'The East Savo Hospital District, BOX 111, 57101, Savonlinna, Finland. kati.auvinen@sosteri.fi.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Räisänen', 'Affiliation': 'The East Savo Hospital District, BOX 111, 57101, Savonlinna, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Merikoski', 'Affiliation': 'Assessment of Pharmacotherapies, Finnish Medicines Agency, Kuopio, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mäntylä', 'Affiliation': 'Assessment of Pharmacotherapies, Finnish Medicines Agency, Kuopio, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kumpusalo-Vauhkonen', 'Affiliation': 'Assessment of Pharmacotherapies, Finnish Medicines Agency, Kuopio, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Enlund', 'Affiliation': 'Assessment of Pharmacotherapies, Finnish Medicines Agency, Kuopio, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Liukkonen', 'Affiliation': 'The South Savo Hospital District, Mikkeli, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jyrkkä', 'Affiliation': 'Assessment of Pharmacotherapies, Finnish Medicines Agency, Kuopio, Finland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lönnroos', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mäntyselkä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}]",Aging clinical and experimental research,['10.1007/s40520-018-1085-8']
24,30941731,Older persons with signs of frailty in a home-based physical exercise intervention: baseline characteristics of an RCT.,"BACKGROUND


Increasing the level of physical activity among persons with signs of frailty improves physical functioning. There is a lack of long-term supervised physical exercise intervention studies including a validated definition of frailty.
AIMS


To present baseline characteristics of persons with signs of frailty participating in a randomized long-term home-based physical exercise trial (HIPFRA), and to study associations between the severity of frailty, functional independence and health-related quality-of-life (HRQoL).
METHODS


Three hundred persons, ≥ 65 years old and with signs of frailty (assessed by Fried´s phenotype criteria) were recruited from South Karelia, Finland and randomized to a 12-month physiotherapist-supervised home-based physical exercise program (n = 150), and usual care (n = 150). Assessments at the participants' homes at baseline, and after 3, 6 and 12 months included the Short Physical Performance Battery (SPPB), the Functional Independence Measure (FIM), HRQoL (15D) and the Mini-Mental State Examination (MMSE).
RESULTS


Eligibility was screened among 520 persons; 300 met the inclusion criteria and were randomized. One person withdrew consent after randomization. A majority (75%) were women, 182 were pre-frail and 117 frail. The mean age was 82.5 (SD 6.3) years, SPPB 6.2 (2.6), FIM 108.8 (10.6) and MMSE 24.4 (3.1) points, with no significant differences between the study groups. Inverse associations between the severity of frailty vs. FIM scores and HRQoL (p < 0.001 for both) were found.
CONCLUSIONS


Our participants showed marked physical frailty without major disabilities. The severity of frailty seems to be associated with impaired functional independence and HRQoL.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02305433.",2019,"Inverse associations between the severity of frailty vs. FIM scores and HRQoL (p < 0.001 for both) were found.
","['persons with signs of frailty improves physical functioning', 'A majority (75%) were women, 182 were pre-frail and 117 frail', 'Older persons with signs of frailty in a home-based', 'persons with signs of frailty participating in a', 'Eligibility was screened among 520 persons; 300 met the inclusion criteria and were randomized', 'Three hundred persons', '65\xa0years old and with signs of frailty (assessed by Fried´s phenotype criteria) were recruited from South Karelia, Finland and randomized to a 12-month']","['randomized long-term home-based physical exercise trial (HIPFRA', 'physical exercise intervention', 'physiotherapist-supervised home-based physical exercise program']","['severity of frailty, functional independence and health-related quality-of-life (HRQoL', 'severity of frailty vs. FIM scores and HRQoL', 'Short Physical Performance Battery (SPPB), the Functional Independence Measure (FIM), HRQoL (15D) and the Mini-Mental State Examination (MMSE']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517803', 'cui_str': '520 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}]",520.0,0.101418,"Inverse associations between the severity of frailty vs. FIM scores and HRQoL (p < 0.001 for both) were found.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Suikkanen', 'Affiliation': 'Rehabilitation, South Karelia Social and Health Care District, Valto Käkelän katu 3, 53130, Lappeenranta, Finland. sara.suikkanen@eksote.fi.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Soukkio', 'Affiliation': 'Rehabilitation, South Karelia Social and Health Care District, Valto Käkelän katu 3, 53130, Lappeenranta, Finland.'}, {'ForeName': 'Kaisu', 'Initials': 'K', 'LastName': 'Pitkälä', 'Affiliation': 'Department of General Practice, and Helsinki University Hospital, Unit of Primary Health Care, University of Helsinki, Tukholmankatu 8 B, 00290, Helsinki, Finland.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Kääriä', 'Affiliation': 'Aureolis Oy, Hevosenkenkä 3, 02600, Espoo, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice, and Helsinki University Hospital, Unit of Primary Health Care, University of Helsinki, Tukholmankatu 8 B, 00290, Helsinki, Finland.'}, {'ForeName': 'Sarianna', 'Initials': 'S', 'LastName': 'Sipilä', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Rautpohjankatu 8, 40700, Jyväskylä, Finland.'}, {'ForeName': 'Katriina', 'Initials': 'K', 'LastName': 'Kukkonen-Harjula', 'Affiliation': 'Rehabilitation, South Karelia Social and Health Care District, Valto Käkelän katu 3, 53130, Lappeenranta, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Hupli', 'Affiliation': 'Rehabilitation, South Karelia Social and Health Care District, Valto Käkelän katu 3, 53130, Lappeenranta, Finland.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01180-z']
25,30604208,Study protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults.,"BACKGROUND


Frailty is a multidimensional geriatric syndrome associated with functional loss. The Senior Chef (SC, nutrition) and SAYGO (strength and balance exercise) programmes are well accepted among older adults but the impact of each, or a combination of both, on the frailty syndrome in pre-frail older adults is unknown.
AIMS


To determine the effectiveness and cost-effectiveness of a complex intervention consisting of the SC and/or SAYGO programmes to prevent progression of frailty in pre-frail older adults.
METHODS


A multi-centre randomised controlled assessor-blinded study. The four intervention groups are SC, an 8-week nutrition education and cooking class; SAYGO, a 10-week strength and balance exercise class; SC plus SAYGO, and a social group (Control). Community-dwelling adults aged 75+ (60 + Māori and Pasifika) in New Zealand are recruited through health providers. Participants are not terminally ill or with advanced dementia, and have a score of 1 or 2 on the FRAIL questionnaire. Baseline assessments are completed using standardised questionnaires prior to randomisation. Four follow-up assessments are completed: immediately after intervention, 6, 12 and 24 months post-intervention. The primary outcome is frailty score, secondary outcomes are falls, physical function, quality of life, food intake, physical activity, and sustainability of the strategy. Study outcomes will be analysed using intention-to-treat approach. Cost analyses will be completed to determine if interventions are cost effective relative to the control group.
DISCUSSION


This trial is designed to be a real world rigorous assessment of whether the two intervention strategies can prevent progression of frailty in older people. If successful, this will generate valuable information about effectiveness of this nutrition and exercise strategy, and provide insights for their implementation.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry number-ACTRN12614000827639.",2019,This trial is designed to be a real world rigorous assessment of whether the two intervention strategies can prevent progression of frailty in older people.,"['older people', 'pre-frail older adults', 'Participants are not terminally ill or with advanced dementia, and have a score of 1 or 2 on the FRAIL questionnaire', 'Australian and New Zealand', 'Community-dwelling adults aged 75+ (60\u2009+\u2009Māori and Pasifika) in New Zealand are recruited through health providers']","['complex intervention consisting of\xa0the SC and/or SAYGO programmes', 'complex intervention', '10-week strength and balance exercise class; SC plus SAYGO, and a social group (Control', 'Senior Chef (SC, nutrition) and SAYGO (strength and balance exercise) programmes']","['frailty score, secondary outcomes are falls, physical function, quality of life, food intake, physical activity, and sustainability of the strategy', 'effectiveness and cost-effectiveness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0039552', 'cui_str': 'Terminally Ill'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0687744', 'cui_str': 'Social group (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0554202', 'cui_str': 'Chef (occupation)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.120841,This trial is designed to be a real world rigorous assessment of whether the two intervention strategies can prevent progression of frailty in older people.,"[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Teh', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, University of Auckland, Auckland, New Zealand. r.teh@auckland.ac.nz.'}, {'ForeName': 'Ngaire', 'Initials': 'N', 'LastName': 'Kerse', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Waters', 'Affiliation': 'Department of Medicine, School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Hale', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Avinesh', 'Initials': 'A', 'LastName': 'Pillai', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Evelingi', 'Initials': 'E', 'LastName': 'Leilua', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Tay', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rolleston', 'Affiliation': 'The Centre of Health, Tauranga, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Edlin', 'Affiliation': 'Health Systems Group, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Eruera', 'Initials': 'E', 'LastName': 'Maxted', 'Affiliation': 'Lakes District Health Board, Rotorua, New Zealand.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Heppenstall', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Connolly', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Auckland, New Zealand.'}]",Aging clinical and experimental research,['10.1007/s40520-018-1106-7']
26,30139903,Effects of menaquinone-7 supplementation in patients with aortic valve calcification: study protocol for a randomised controlled trial.,"INTRODUCTION


Aortic stenosis is a common heart valve disease, and due to the growing elderly population, the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps. A few attempts with medical preventive treatment have failed; thus, presently, the only effective treatment of aortic stenosis is surgery. This study will examine the effect of menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC). We hypothesise that MK-7 supplementation will slow down the calcification process.
METHODS AND ANALYSIS


In this multicenter and double-blinded, placebo-controlled study, 400 men aged 65-74 years with substantial AVC are randomised (1:1) to treatment with MK-7 (720 µg/day) supplemented by the recommended daily dose of vitamin D (25 µg/day) or placebo treatment (no active treatment) for 2 years. Exclusion criteria are treatment with vitamin K antagonist or coagulation disorders. To evaluate AVC score, a non-contrast CT scan is performed at baseline and repeated after 12 and 24 months of follow-up. Primary outcome is difference in AVC score from baseline to follow-up at 2 years. Intention-to-treat principle is used for all analyses.
ETHICS AND DISSEMINATION


There are no reported adverse effects associated with the use of MK-7. The protocol is approved by the Regional Scientific Ethical Committee for Southern Denmark (S-20170059) and the Data Protection Agency (17/19010). It is conducted in accordance with the Declaration of Helsinki. Positive as well as negative findings will be reported.
TRIAL REGISTRATION NUMBER


NCT03243890.",2018,There are no reported adverse effects associated with the use of MK-7.,"['400 men aged 65-74 years with substantial AVC', 'patients with aortic valve calcification']","['vitamin D', 'MK-7', 'placebo', 'placebo treatment (no active treatment', 'menaquinone-7 (MK-7) supplementation', 'vitamin K antagonist', 'menaquinone-7 supplementation']","['progression of aortic valve calcification (AVC', 'AVC score']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0428791', 'cui_str': 'Aortic Stenosis, Calcific'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0428791', 'cui_str': 'Aortic Stenosis, Calcific'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",400.0,0.255185,There are no reported adverse effects associated with the use of MK-7.,"[{'ForeName': 'Jes Sanddal', 'Initials': 'JS', 'LastName': 'Lindholt', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Niels Erik', 'Initials': 'NE', 'LastName': 'Frandsen', 'Affiliation': 'Kirkestenten 16, Skt Klemens, Odense C, Denmark.'}, {'ForeName': 'Maise Høigaard', 'Initials': 'MH', 'LastName': 'Fredgart', 'Affiliation': 'Department of Cardiology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Kristian A', 'Initials': 'KA', 'LastName': 'Øvrehus', 'Affiliation': 'Department of Cardiology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Jordi Sanchez', 'Initials': 'JS', 'LastName': 'Dahl', 'Affiliation': 'Department of Cardiology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Folkestad', 'Affiliation': 'Department of Endocrinology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Grazina', 'Initials': 'G', 'LastName': 'Urbonaviciene', 'Affiliation': 'Department of Cardiology, Silkeborg Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Søren Warberg', 'Initials': 'SW', 'LastName': 'Becker', 'Affiliation': 'Department of Cardiology, Silkeborg Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Lambrechtsen', 'Affiliation': 'Department of Cardiology, Svendborg Sygehus, Svendborg, Syddanmark, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Auscher', 'Affiliation': 'Department of Cardiology, Svendborg Sygehus, Svendborg, Syddanmark, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Hosbond', 'Affiliation': 'Department of Cardiology, Vejle Hospital, Vejle, Denmark.'}, {'ForeName': 'Dilek Hunerel', 'Initials': 'DH', 'LastName': 'Alan', 'Affiliation': 'Department of Cardiology, Vejle Hospital, Vejle, Denmark.'}, {'ForeName': 'Lars Melholt', 'Initials': 'LM', 'LastName': 'Rasmussen', 'Affiliation': 'Centre for Individualized Medicine in Arterial Diseases, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Oke', 'Initials': 'O', 'LastName': 'Gerke', 'Affiliation': 'Department of Nuclear Medicine, Odense Universitetshospital, Odense C, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Mickley', 'Affiliation': 'Department of Cardiology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Diederichsen', 'Affiliation': 'Centre for Individualized Medicine in Arterial Diseases, Odense Universitetshospital, Odense, Denmark.'}]",BMJ open,['10.1136/bmjopen-2018-022019']
27,26908424,Steady-state vitamin K2 (menaquinone-7) plasma concentrations after intake of dairy products and soft gel capsules.,"BACKGROUND


In a previous human intervention study, we observed an improved vitamin K status after 8 weeks of intake of a yogurt that was fortified with vitamin K2 (as menaquinone-7, MK-7) and enriched with vitamins C and D3, magnesium and polyunsaturated fatty acids. It was hypothesized that the added nutrients contributed to this improvement. Here we report on a study in which we compared the fasting plasma concentrations of MK-7 from (a) yogurt enriched with MK-7, vitamins D3 and C, magnesium, n-3 poly unsaturated fatty acids (n-3 PUFA) and fish oil (yogurt Kplus), (b) yogurt fortified with MK-7 only (yogurt K) and (c) soft gel capsules containing only MK-7.
SUBJECTS/METHODS


For 42 days, healthy men and postmenopausal women between 45 and 65 years of age daily consumed either yogurt K, yogurt Kplus or capsules. Circulating MK-7, 25-hydroxy vitamin D (25(OH)D) and markers for vitamin K status (uncarboxylated osteocalcin (ucOC) and desphospho-uncarboxylated matrix Gla-protein (dp-ucMGP)) were assessed. Plasma MK-7 was also measured during the washout period of 2 weeks. MK-7 and dp-ucMGP were measured in citrated plasma, and 25(OH)D3 and ucOC were measured in the serum.
RESULTS


The increase in plasma MK-7 with the yogurt Kplus product was more pronounced than the increase in MK-7 with the capsules. Circulating dp-ucMGP and ucOC were significantly lowered after consumption of the yogurt products and the MK-7 capsules, reflecting vitamin K status improvement. No significant differences in fasting plasma concentrations of various biomarkers between the yogurts were found.
CONCLUSIONS


Dairy matrix and nutrient composition may affect MK-7 delivery and improvement of vitamin K status. Yogurt fortified with MK-7 is a suitable matrix to improve the nutritional status of the fat-soluble vitamins.",2016,"Circulating dp-ucMGP and ucOC were significantly lowered after consumption of the yogurt products and the MK-7 capsules, reflecting vitamin K status improvement.","['healthy men and postmenopausal women between 45 and 65 years of age daily consumed either yogurt K, yogurt Kplus or capsules']","['vitamin K2 (as menaquinone-7, MK-7) and enriched with vitamins C and D3, magnesium and polyunsaturated fatty acids', 'Yogurt fortified with MK-7', 'MK-7 from (a) yogurt enriched with MK-7, vitamins D3 and C, magnesium, n-3 poly unsaturated fatty acids (n-3 PUFA) and fish oil (yogurt Kplus), (b) yogurt fortified with MK-7 only (yogurt K) and (c) soft gel capsules containing only MK-7', 'Steady-state vitamin K2']","['plasma MK-7', 'vitamin K status', 'citrated plasma, and 25(OH)D3 and ucOC', 'Circulating dp-ucMGP and ucOC', 'Circulating MK-7, 25-hydroxy vitamin D (25(OH)D) and markers for vitamin K status (uncarboxylated osteocalcin (ucOC) and desphospho-uncarboxylated matrix Gla-protein (dp-ucMGP', 'Plasma MK-7', 'fasting plasma concentrations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0065752', 'cui_str': 'matrix gamma-carboxyglutamic acid protein'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0228968,"Circulating dp-ucMGP and ucOC were significantly lowered after consumption of the yogurt products and the MK-7 capsules, reflecting vitamin K status improvement.","[{'ForeName': 'M H J', 'Initials': 'MH', 'LastName': 'Knapen', 'Affiliation': 'R&D Group VitaK, Biopartner Center Maastricht, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'L A J L M', 'Initials': 'LA', 'LastName': 'Braam', 'Affiliation': 'R&D Group VitaK, Biopartner Center Maastricht, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Teunissen', 'Affiliation': 'R&D Group VitaK, Biopartner Center Maastricht, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': ""Van't Hoofd"", 'Affiliation': 'R&D Group VitaK, Biopartner Center Maastricht, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'R M L', 'Initials': 'RM', 'LastName': 'Zwijsen', 'Affiliation': 'FrieslandCampina, Amersfoort, The Netherlands.'}, {'ForeName': 'E G H M', 'Initials': 'EG', 'LastName': 'van den Heuvel', 'Affiliation': 'FrieslandCampina, Amersfoort, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vermeer', 'Affiliation': 'R&D Group VitaK, Biopartner Center Maastricht, Maastricht University, Maastricht, The Netherlands.'}]",European journal of clinical nutrition,['10.1038/ejcn.2016.3']
28,24285428,Vitamin K2 supplementation in haemodialysis patients: a randomized dose-finding study.,"BACKGROUND


Haemodialysis patients suffer from accelerated vascular calcification. The vitamin K-dependent matrix Gla protein (MGP) is one of the most powerful inhibitors of vascular calcification. Haemodialysis patients have high levels of the inactive form of MGP (desphosphorylated-uncarboxylated-MGP, dp-uc-MGP) and may benefit from pharmacological doses of vitamin K2 (menaquinone) to improve the calcification inhibitory activity of MGP.
METHODS


To determine the optimal dose of menaquinone-7 (MK-7) for MGP activation, 200 chronic haemodialysis patients were recruited to randomly receive 360, 720 or 1080 µg of MK-7 thrice weekly for 8 weeks. Dp-uc-MGP was measured at baseline and after 8 weeks. Dietary intake of vitamin K1 (phylloquinone) and menaquinone was estimated based on a detailed questionnaire.
RESULTS


At baseline, dp-uc-MGP was not associated with phylloquinone intake (P = 0.92), but correlated inversely with menaquinone intake (P = 0.023). MK-7 supplementation dose dependently reduced dp-uc-MGP. The levels decreased by 17, 33 and 46% in the respective groups. Drop-outs were mainly due to gastrointestinal side-effects related to the unpleasant smell of the tablets.
CONCLUSIONS


Chronic haemodialysis patients have high levels of inactive MGP, possibly related to a low dietary vitamin K intake. Pharmacological doses of MK-7 dose-dependently reduce dp-uc-MGP. Menaquinone supplementation may be a novel approach to prevent vascular calcifications in chronic haemodialysis patients.",2014,"At baseline, dp-uc-MGP was not associated with phylloquinone intake (P = 0.92), but correlated inversely with menaquinone intake (P = 0.023). MK-7 supplementation dose dependently reduced dp-uc-MGP.","['Haemodialysis patients', '200 chronic haemodialysis patients', 'haemodialysis patients', 'Haemodialysis patients suffer from accelerated vascular calcification', 'Chronic haemodialysis patients', 'chronic haemodialysis patients']","['vitamin K2 (menaquinone', 'Vitamin K2 supplementation', 'Menaquinone supplementation', 'vitamin K1 (phylloquinone) and menaquinone', 'vitamin K-dependent matrix Gla protein (MGP', 'menaquinone-7 (MK-7', 'MK-7']","['Dp-uc-MGP', 'menaquinone intake']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0342649', 'cui_str': 'Vascular Calcinosis'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0086605', 'cui_str': 'Vitamin K 2'}, {'cui': 'C0031862', 'cui_str': 'phytonadione'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0065752', 'cui_str': 'matrix gamma-carboxyglutamic acid protein'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}]","[{'cui': 'C0086605', 'cui_str': 'Vitamin K 2'}]",,0.0349539,"At baseline, dp-uc-MGP was not associated with phylloquinone intake (P = 0.92), but correlated inversely with menaquinone intake (P = 0.023). MK-7 supplementation dose dependently reduced dp-uc-MGP.","[{'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Caluwé', 'Affiliation': 'Division of Nephrology, OLV Hospital, Aalst, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'Division of Nephrology and Infectious Diseases, AZ St.-Jan Hospital, Brugge, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Van Vlem', 'Affiliation': 'Division of Nephrology, OLV Hospital, Aalst, Belgium.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Vermeer', 'Affiliation': 'VitaK, Maastricht University, EV Maastricht, the Netherlands.'}, {'ForeName': 'An S', 'Initials': 'AS', 'LastName': 'De Vriese', 'Affiliation': 'Division of Nephrology and Infectious Diseases, AZ St.-Jan Hospital, Brugge, Belgium.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gft464']
29,26073022,Menaquinone-7 as a novel pharmacological therapy in the treatment of rheumatoid arthritis: A clinical study.,"Menaquinones (MKs) have been reported to induce apoptosis in rheumatoid arthritis (RA) synovial cells. Recently, menaquinone-4 (MK-4) was proven as a new potential agent for the treatment of RA. However, menaquinone-7 (MK-7) has greater bioavailability and efficacy than MK-4 after oral administration. Yet, the therapeutic benefits of MK-7 in the management of patients with RA have never been addressed. This study was designed to clarify the therapeutic role of MK-7 added to normal therapeutic regimen of RA in patients with different stages of the disease with a clinical follow up through a randomized clinical trial. In a cross sectional study, 84 RA patients (24 male, 60 female) (average age=47.2 years) were enrolled in this study. The patients were divided into MK-7 treated group (n=42) and MK-7 naïve group (n=42). MK-7 capsules were administered in a dose of 100µg/day for three months in the first group without changing in other medications. The clinical and biochemical markers on RA patients treated with MK-7 and naïve group were assessed. In MK-7 treated group, serum concentrations of MK-7 were monitored before and after three months of MK-7 administration. In the cross sectional study, a significant decrease in MK-7 treated group for the levels of undercarboxylated osteocalcin (ucOC), erythrocyte sedimentation rate (ESR), disease activity score assessing 28 joints with ESR (DAS28-ESR), C-reactive protein (CRP) and matrix metalloproteinase (MMP-3) was found. In MK-7 treated group, a marked decrease in RA clinical and biochemical markers for moderate and good response compared to non-responders was observed in ucOC, ESR and DAS28-ESR. A marked increase in the levels of MK-7 for the moderate and good responders compared to non-responders was observed. The results suggest that MK-7 improves disease activity in RA patients. Therefore, MK-7 represents a new promising agent for RA in combination therapy with other disease modifying antirheumatic drugs.",2015,A marked increase in the levels of MK-7 for the moderate and good responders compared to non-responders was observed.,"['patients with different stages of the disease with a clinical follow up through a randomized clinical trial', 'rheumatoid arthritis', 'RA patients', '84 RA patients (24 male, 60 female) (average age=47.2 years', 'patients with RA']","['MK-7 capsules', 'Menaquinone-7', 'Menaquinones (MKs', 'MK-7 naïve group', 'menaquinone-7 (MK-7', 'MK-7', 'RA']","['levels of MK-7', 'serum concentrations of MK-7', 'RA clinical and biochemical markers for moderate and good response', 'bioavailability and efficacy', 'undercarboxylated osteocalcin (ucOC), erythrocyte sedimentation rate (ESR), disease activity score assessing 28 joints with ESR (DAS28-ESR), C-reactive protein (CRP) and matrix metalloproteinase (MMP-3', 'disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",84.0,0.0127683,A marked increase in the levels of MK-7 for the moderate and good responders compared to non-responders was observed.,"[{'ForeName': 'Mahran S', 'Initials': 'MS', 'LastName': 'Abdel-Rahman', 'Affiliation': 'Department of Pharmacology and Toxicology, College of Pharmacy, Taibah University, Al Madinah AlMunawarah 30001, Saudi Arabia; Department of Pharmacology, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: mahran44@hotmail.com.'}, {'ForeName': 'Eman A M', 'Initials': 'EA', 'LastName': 'Alkady', 'Affiliation': 'Department of Rheumatology & Rehabilitation, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pharmacognosy and Pharmaceutical Chemistry, College of Pharmacy, Taibah University, Al Madinah AlMunawarah 30001, Saudi Arabia; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Assiut 71526, Egypt.'}]",European journal of pharmacology,['10.1016/j.ejphar.2015.06.014']
30,25694037,Menaquinone-7 supplementation improves arterial stiffness in healthy postmenopausal women. A double-blind randomised clinical trial.,"Observational data suggest a link between menaquinone (MK, vitamin K2) intake and cardiovascular (CV) health. However, MK intervention trials with vascular endpoints are lacking. We investigated long-term effects of MK-7 (180 µg MenaQ7/day) supplementation on arterial stiffness in a double-blind, placebo-controlled trial. Healthy postmenopausal women (n=244) received either placebo (n=124) or MK-7 (n=120) for three years. Indices of local carotid stiffness (intima-media thickness IMT, Diameter end-diastole and Distension) were measured by echotracking. Regional aortic stiffness (carotid-femoral and carotid-radial Pulse Wave Velocity, cfPWV and crPWV, respectively) was measured using mechanotransducers. Circulating desphospho-uncarboxylated matrix Gla-protein (dp-ucMGP) as well as acute phase markers Interleukin-6 (IL-6), high-sensitive C-reactive protein (hsCRP), tumour necrosis factor-α (TNF-α) and markers for endothelial dysfunction Vascular Cell Adhesion Molecule (VCAM), E-selectin, and Advanced Glycation Endproducts (AGEs) were measured. At baseline dp-ucMGP was associated with IMT, Diameter, cfPWV and with the mean z-scores of acute phase markers (APMscore) and of markers for endothelial dysfunction (EDFscore). After three year MK-7 supplementation cfPWV and the Stiffness Index βsignificantly decreased in the total group, whereas distension, compliance, distensibility, Young's Modulus, and the local carotid PWV (cPWV) improved in women having a baseline Stiffness Index β above the median of 10.8. MK-7 decreased dp-ucMGP by 50 % compared to placebo, but did not influence the markers for acute phase and endothelial dysfunction. In conclusion, long-term use of MK-7 supplements improves arterial stiffness in healthy postmenopausal women, especially in women having a high arterial stiffness.",2015,"After three year MK-7 supplementation cfPWV and the Stiffness Index βsignificantly decreased in the total group, whereas distension, compliance, distensibility, Young's Modulus, and the local carotid PWV (cPWV) improved in women having a baseline Stiffness Index β above the median of 10.8. MK-7 decreased dp-ucMGP by 50 % compared to placebo, but did not influence the markers for acute phase and endothelial dysfunction.","['healthy postmenopausal women', 'Healthy postmenopausal women (n=244']","['placebo', 'MK-7 (180 µg MenaQ7/day) supplementation', 'Menaquinone-7 supplementation', 'MK-7', 'MK-7 supplements']","['acute phase and endothelial dysfunction', ""distension, compliance, distensibility, Young's Modulus, and the local carotid PWV (cPWV"", 'Regional aortic stiffness (carotid-femoral and carotid-radial Pulse Wave Velocity, cfPWV and crPWV, respectively', 'arterial stiffness', 'local carotid stiffness (intima-media thickness IMT, Diameter end-diastole and Distension', 'menaquinone (MK, vitamin K2) intake and cardiovascular (CV) health', 'Stiffness Index βsignificantly']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}]","[{'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0232142', 'cui_str': 'Radial pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1562146', 'cui_str': 'End diastole'}, {'cui': 'C0086605', 'cui_str': 'Vitamin K 2'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.388488,"After three year MK-7 supplementation cfPWV and the Stiffness Index βsignificantly decreased in the total group, whereas distension, compliance, distensibility, Young's Modulus, and the local carotid PWV (cPWV) improved in women having a baseline Stiffness Index β above the median of 10.8. MK-7 decreased dp-ucMGP by 50 % compared to placebo, but did not influence the markers for acute phase and endothelial dysfunction.","[{'ForeName': 'Marjo H J', 'Initials': 'MH', 'LastName': 'Knapen', 'Affiliation': ''}, {'ForeName': 'Lavienja A J L M', 'Initials': 'LA', 'LastName': 'Braam', 'Affiliation': ''}, {'ForeName': 'Nadja E', 'Initials': 'NE', 'LastName': 'Drummen', 'Affiliation': ''}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Bekers', 'Affiliation': ''}, {'ForeName': 'Arnold P G', 'Initials': 'AP', 'LastName': 'Hoeks', 'Affiliation': ''}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Vermeer', 'Affiliation': 'Cees Vermeer, PhD, VitaK, Maastricht University, Biopartner Center Maastricht, Oxfordlaan 70, 6229 EV Maastricht, The Netherlands, Tel: +31 43 388 5865, Fax: +31 43 388 5889, E-mail: c.vermeer@vitak.com.'}]",Thrombosis and haemostasis,['10.1160/TH14-08-0675']
31,26181658,Safety and Efficacy of Fedratinib in Patients With Primary or Secondary Myelofibrosis: A Randomized Clinical Trial.,"IMPORTANCE


Myelofibrosis (MF) is a BCR-ABL-negative myeloproliferative neoplasm characterized by anemia, splenomegaly, debilitating constitutional symptoms, and shortened survival. Fedratinib, a JAK2-selective inhibitor, previously demonstrated clinically beneficial activity in patients with MF in early-phase trials.
OBJECTIVE


To evaluate the efficacy and safety of fedratinib therapy in patients with primary or secondary (post-polycythemia vera or post-essential thrombocythemia) MF.
DESIGN, SETTING, AND PARTICIPANTS


Double-blind, randomized, placebo-controlled phase 3 study in 94 sites in 24 countries in which 289 adult patients (≥18 years of age) with intermediate-2 or high-risk primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF were randomly assigned between December 2011 and September 2012 to once-daily oral fedratinib, at a dose of 400 mg or 500 mg, or placebo, for at least 6 consecutive 4-week cycles.
MAIN OUTCOMES AND MEASURES


The primary end point was spleen response (≥35% reduction in spleen volume from baseline as determined by magnetic resonance imaging or computed tomography) at week 24 and confirmed 4 weeks later. The main secondary end point was symptom response (≥50% reduction in total symptom score, assessed using the modified Myelofibrosis Symptom Assessment Form).
RESULTS


The primary end point was achieved by 35 of 96 (36% [95% CI, 27%-46%]) and 39 of 97 (40% [95% CI, 30%-50%]) patients in the fedratinib 400-mg and 500-mg groups, vs 1 of 96 (1% [95% CI, 0%-3%]) in the placebo group (P < .001). Symptom response rates at week 24 were 33 of 91 (36% [95% CI, 26%-46%]), 31 of 91 (34% [95% CI, 24%-44%]), and 6 of 85 (7% [95% CI, 2%-13%]) in the fedratinib 400-mg, 500-mg, and placebo groups, respectively (P < .001). Common adverse events with fedratinib treatment were anemia, gastrointestinal symptoms, and increased levels of liver transaminases, serum creatinine, and pancreatic enzymes. Encephalopathy was reported in 4 women who received fedratinib 500 mg/d. A diagnosis of Wernicke encephalopathy was supported by magnetic resonance imaging in 3 cases and suspected clinically in 1 case.
CONCLUSIONS AND RELEVANCE


Fedratinib therapy significantly reduced splenomegaly and symptom burden in patients with MF. These benefits were accompanied by toxic effects in some patients, the most important being encephalopathy of unknown mechanism. Clinical development of fedratinib was subsequently discontinued.
TRIAL REGISTRATION


clinicaltrials.gov identifier: NCT01437787.",2015,"Common adverse events with fedratinib treatment were anemia, gastrointestinal symptoms, and increased levels of liver transaminases, serum creatinine, and pancreatic enzymes.","['patients with primary or secondary (post-polycythemia vera or post-essential thrombocythemia) MF', 'patients with MF', 'controlled phase 3 study in 94 sites in 24 countries in which 289 adult patients (≥18 years of age) with intermediate-2 or high-risk primary MF, post-polycythemia vera MF, or post-essential thrombocythemia', 'Patients With Primary or Secondary Myelofibrosis', 'patients with MF in early-phase trials']","['fedratinib therapy', 'placebo']","['total symptom score, assessed using the modified Myelofibrosis Symptom Assessment Form', 'efficacy and safety', 'spleen response', 'splenomegaly and symptom burden', 'symptom response', 'toxic effects', 'anemia, gastrointestinal symptoms, and increased levels of liver transaminases, serum creatinine, and pancreatic enzymes', 'Safety and Efficacy', 'Encephalopathy', 'Symptom response rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0032463', 'cui_str': 'Primary Polycythemia'}, {'cui': 'C0040028', 'cui_str': 'Thrombocytosis, Primary'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0242006', 'cui_str': 'Myelofibrosis due to another disorder'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001815', 'cui_str': 'Idiopathic Myelofibrosis'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0038002', 'cui_str': 'Enlarged Spleen'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0920330', 'cui_str': 'Product containing pancreatic enzyme (product)'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathies'}]",289.0,0.588306,"Common adverse events with fedratinib treatment were anemia, gastrointestinal symptoms, and increased levels of liver transaminases, serum creatinine, and pancreatic enzymes.","[{'ForeName': 'Animesh', 'Initials': 'A', 'LastName': 'Pardanani', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Harrison', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, England.""}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cervantes', 'Affiliation': 'Hospital Clinic, IDIBAPS University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ruben A', 'Initials': 'RA', 'LastName': 'Mesa', 'Affiliation': 'Division of Hematology-Oncology, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Milligan', 'Affiliation': 'Centre for Haematology and Stem Cell Transplantation, Heartlands Hospital, Birmingham, England.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Masszi', 'Affiliation': 'Department of Haematology and Stem Cell Transplantation, St István and St László Hospital, Budapest, Hungary.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Mishchenko', 'Affiliation': 'Hematology-Oncology Unit, Bnai-Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jourdan', 'Affiliation': 'Groupe Hospitalo-Universitaire Nimes, Nimes, France.'}, {'ForeName': 'Alessandro M', 'Initials': 'AM', 'LastName': 'Vannucchi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Drummond', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, Scotland.'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Jurgutis', 'Affiliation': ""Hematology Department, Klaipeda Seamen's Hospital, Klaipeda, Lithuania.""}, {'ForeName': 'Kazimierz', 'Initials': 'K', 'LastName': 'Kuliczkowski', 'Affiliation': 'Department of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Emanuil', 'Initials': 'E', 'LastName': 'Gheorghita', 'Affiliation': 'Brasov Country Hospital, Brasov, Romania.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Passamonti', 'Affiliation': 'University Hospital Ospedale di Circolo e Fondazione Macchi, Varese, Italy.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Neumann', 'Affiliation': 'Sanofi Oncology, Cambridge, Massachusetts.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Patki', 'Affiliation': 'Sanofi Oncology, Cambridge, Massachusetts.'}, {'ForeName': 'Guozhi', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Sanofi Oncology, Cambridge, Massachusetts.'}, {'ForeName': 'Ayalew', 'Initials': 'A', 'LastName': 'Tefferi', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, Minnesota.'}]",JAMA oncology,['10.1001/jamaoncol.2015.1590']
32,31049671,"Music, heart rate variability, and symptom clusters: a comparative study.","PURPOSE


This study aimed to explore the possible range of change of a single-session music intervention (SMI) on symptom clusters and neurological reactivity for women with breast cancer undergoing chemotherapy.
METHODS


A parallel and randomized, controlled study with repeated measures design was used. A total of 100 women with breast cancer were randomly assigned to the SMI or a control group. The outcome measurements of symptom cluster were collected using the Multidimensional Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, and the neurological reactivity with heart rate variability at four time points: before commencement of the intervention (T0), immediately afterward (T1), 1 week later (T2), and 3 weeks after the intervention (T3).
RESULTS


Of the 50 women in each group, 46 in the SMI and 48 in the control group completed the post-test at T3. Multivariate analysis of variance indicated that the SMI group had a medium effect in change of symptom clusters compared to the control group at T2. Moreover, after adjusting for baseline between normal and higher levels of sympathetic tone activity, significant differences existed in fatigue and depression at T2 and sleep disturbance at T3.
CONCLUSIONS


A single-session music intervention can be effectively used to reduce symptom clusters for women with breast cancer. Targeting those who have a higher level of sympathetic tone activity is recommended.",2020,Multivariate analysis of variance indicated that the SMI group had a medium effect in change of symptom clusters compared to the control group at T2.,"['women with breast cancer', '100 women with breast cancer', 'women with breast cancer undergoing chemotherapy']","['single-session music intervention (SMI', 'SMI']","['Multidimensional Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, and the neurological reactivity with heart rate variability', 'Music, heart rate variability, and symptom clusters', 'sympathetic tone activity', 'change of symptom clusters', 'symptom clusters', 'symptom clusters and neurological reactivity', 'fatigue and depression at T2 and sleep disturbance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}]","[{'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]",100.0,0.0841135,Multivariate analysis of variance indicated that the SMI group had a medium effect in change of symptom clusters compared to the control group at T2.,"[{'ForeName': 'Shu-Chuan', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Nathan, Brisbane, Queensland, 4111, Australia.'}, {'ForeName': 'Ming-Lee', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'Department of Thanatology and Health Counseling, National Taipei University of Nursing and Health Science, No. 365, Ming-te Road, Peitou District, Taipei, 11219, Taiwan, Republic of China.'}, {'ForeName': 'Hsiu-Ju', 'Initials': 'HJ', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, College of Nursing, Taipei Medical University, No.250, Wu-Hsing Street, Taipei, 110, Taiwan, Republic of China.'}, {'ForeName': 'Mei-Feng', 'Initials': 'MF', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, No. 1, Tai-Hsueh Road, Tainan, 701, Taiwan, Republic of China. L30mf@mail.ncku.edu.tw.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04817-x']
33,23140417,Comparison of menaquinone-4 and menaquinone-7 bioavailability in healthy women.,"BACKGROUND


Vitamin K₂ contributes to bone and cardiovascular health. Therefore, two vitamin K₂ homologues, menaquinone-4 (MK-4) and menaquinone-7 (MK-7), have been used as nutrients by the food industry and as nutritional supplements to support bone and cardiovascular health. However, little is known about the bioavailability of nutritional MK-4. To investigate MK-4 and MK-7 bioavailability, nutritional doses were administered to healthy Japanese women.
FINDINGS


Single dose administration of MK-4 (420 μg; 945 nmol) or MK-7 (420 μg; 647 nmol) was given in the morning together with standardized breakfast. MK-7 was well absorbed and reached maximal serum level at 6 h after intake and was detected up to 48 h after intake. MK-4 was not detectable in the serum of all subjects at any time point. Consecutive administration of MK-4 (60 μg; 135 nmol) or MK-7 (60 μg; 92 nmol) for 7 days demonstrated that MK-4 supplementation did not increase serum MK-4 levels. However, consecutive administration of MK-7 increased serum MK-7 levels significantly in all subjects.
CONCLUSIONS


We conclude that MK-4 present in food does not contribute to the vitamin K status as measured by serum vitamin K levels. MK-7, however significantly increases serum MK-7 levels and therefore may be of particular importance for extrahepatic tissues.",2012,"MK-7, however significantly increases serum MK-7 levels and therefore may be of particular importance for extrahepatic tissues.","['healthy women', 'healthy Japanese women']","['MK-4 supplementation', 'MK-4', 'menaquinone-4 (MK-4) and menaquinone-7 (MK-7', 'MK-7', 'menaquinone-4 and menaquinone-7 bioavailability']","['serum vitamin K levels', 'MK-4', 'serum MK-4 levels', 'serum MK-7 levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]","[{'cui': 'C0443768', 'cui_str': 'Serum vitamin K measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0172086,"MK-7, however significantly increases serum MK-7 levels and therefore may be of particular importance for extrahepatic tissues.","[{'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Fine Chemical Laboratory, J-OIL MILLS, INC, 1746 Nakashinden, Fukuroi-city, Shizuoka, 437-1111, Japan. toshiro.sato@j-oil.com'}, {'ForeName': 'Leon J', 'Initials': 'LJ', 'LastName': 'Schurgers', 'Affiliation': ''}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Uenishi', 'Affiliation': ''}]",Nutrition journal,['10.1186/1475-2891-11-93']
34,23525894,Three-year low-dose menaquinone-7 supplementation helps decrease bone loss in healthy postmenopausal women.,"UNLABELLED


We have investigated whether low-dose vitamin K2 supplements (menaquinone-7, MK-7) could beneficially affect bone health. Next to an improved vitamin K status, MK-7 supplementation significantly decreased the age-related decline in bone mineral density and bone strength. Low-dose MK-7 supplements may therefore help postmenopausal women prevent bone loss.
INTRODUCTION


Despite contradictory data on vitamin K supplementation and bone health, the European Food Safety Authorities (EFSA) accepted the health claim on vitamin K's role in maintenance of normal bone. In line with EFSA's opinion, we showed that 3-year high-dose vitamin K1 (phylloquinone) and K2 (short-chain menaquinone-4) supplementation improved bone health after menopause. Because of the longer half-life and greater potency of the long-chain MK-7, we have extended these investigations by measuring the effect of low-dose MK-7 supplementation on bone health.
METHODS


Healthy postmenopausal women (n = 244) received for 3 years placebo or MK-7 (180 μg MK-7/day) capsules. Bone mineral density of lumbar spine, total hip, and femoral neck was measured by DXA; bone strength indices of the femoral neck were calculated. Vertebral fracture assessment was performed by DXA and used as measure for vertebral fractures. Circulating uncarboxylated osteocalcin (ucOC) and carboxylated OC (cOC) were measured; the ucOC/cOC ratio served as marker of vitamin K status. Measurements occurred at baseline and after 1, 2, and 3 years of treatment.
RESULTS


MK-7 intake significantly improved vitamin K status and decreased the age-related decline in BMC and BMD at the lumbar spine and femoral neck, but not at the total hip. Bone strength was also favorably affected by MK-7. MK-7 significantly decreased the loss in vertebral height of the lower thoracic region at the mid-site of the vertebrae.
CONCLUSIONS


MK-7 supplements may help postmenopausal women to prevent bone loss. Whether these results can be extrapolated to other populations, e.g., children and men, needs further investigation.",2013,"Next to an improved vitamin K status, MK-7 supplementation significantly decreased the age-related decline in bone mineral density and bone strength.","['healthy postmenopausal women', 'Healthy postmenopausal women (n\u2009=\u2009244']","['vitamin K1 (phylloquinone) and K2 (short-chain menaquinone-4) supplementation', 'menaquinone-7 supplementation', 'Low-dose MK-7 supplements', 'vitamin K2 supplements (menaquinone-7, MK-7', 'placebo or MK-7', 'MK-7 supplements']","['vitamin K status', 'Vertebral fracture assessment', 'Bone strength', 'Circulating uncarboxylated osteocalcin (ucOC) and carboxylated OC (cOC', 'Bone mineral density of lumbar spine, total hip, and femoral neck', 'bone health', 'bone loss', 'BMC and BMD', 'vertebral height', 'bone mineral density and bone strength', 'vitamin K status, MK-7 supplementation']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}]","[{'cui': 'C0031862', 'cui_str': 'phytonadione'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",,0.066873,"Next to an improved vitamin K status, MK-7 supplementation significantly decreased the age-related decline in bone mineral density and bone strength.","[{'ForeName': 'M H J', 'Initials': 'MH', 'LastName': 'Knapen', 'Affiliation': 'VitaK, Maastricht University, Oxfordlaan 70, 6229 EV, Maastricht, The Netherlands.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Drummen', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Smit', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vermeer', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Theuwissen', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-013-2325-6']
35,31701267,The use of stretching devices for treatment of trismus in head and neck cancer patients: a randomized controlled trial.,"PURPOSE


To compare the effects of two stretching devices, the TheraBite® Jaw Motion Rehabilitation System™ and the Dynasplint Trismus System®, on maximal mouth opening in head and neck cancer patients.
METHODS


Patients were randomly assigned to one of two exercise groups: the TheraBite® Jaw Motion Rehabilitation System™ group or the Dynasplint Trismus System® group. Patients performed stretching exercises for 3 months. During the three study visits, maximal mouth opening was measured and the patients completed questionnaires on mandibular function and quality of life.
RESULTS


In our study population (n = 27), five patients did not start the exercise protocol, eight patients discontinued exercises, and two patients were lost to follow-up. No significant differences regarding the change in mouth opening between the two devices were found. Patients had an increase in MMO of 3.0 mm (IQR - 2.0; 4.0) using the TheraBite® Jaw Motion Rehabilitation System™ and 1.5 mm (IQR 1.0; 3.0) using the Dynasplint Trismus System®. Exercising with either stretching device was challenging for the patients due to the intensive exercise protocol, pain during the exercises, fitting problems with the stretching device, and overall deterioration of their medical condition.
CONCLUSIONS


The effects of the two stretching devices did not differ significantly in our study population. The factors described, influencing the progression of stretching exercises, need to be taken into account when prescribing a similar stretching regimen for trismus in head and neck cancer patients.
TRIAL REGISTRATION


NTR - Dutch Trial Register number: 5589.",2020,No significant differences regarding the change in mouth opening between the two devices were found.,"['Patients', 'head and neck cancer patients']","['stretching devices', 'Exercising with either stretching device', 'stretching exercises', 'TheraBite® Jaw Motion Rehabilitation System™ group or the Dynasplint Trismus System® group']","['mandibular function and quality of life', 'change in mouth opening', 'MMO', 'maximal mouth opening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",,0.058782,No significant differences regarding the change in mouth opening between the two devices were found.,"[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'van der Geer', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands. s.j.van.der.geer@umcg.nl.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Reintsema', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.'}, {'ForeName': 'Jolanda I', 'Initials': 'JI', 'LastName': 'Kamstra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.'}, {'ForeName': 'Jan L N', 'Initials': 'JLN', 'LastName': 'Roodenburg', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.'}, {'ForeName': 'Pieter U', 'Initials': 'PU', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05075-7']
36,27136912,Effect of food on the bioavailability and tolerability of the JAK2-selective inhibitor fedratinib (SAR302503): Results from two phase I studies in healthy volunteers.,"Fedratinib (SAR302503/TG101348) is a Janus kinase 2 (JAK2)-selective inhibitor developed for treatment of patients with myelofibrosis. The effect of food intake on the pharmacokinetics (PKs) and tolerability of single-dose fedratinib was investigated in two Phase I studies (FED12258: 100 mg or 500 mg under fasted or fed [high-fat breakfast] conditions; ALI13451: 500 mg under fasted or fed [low- or high-fat breakfast] conditions) in healthy male subjects. At the 500 mg dose the fed:fasted ratio estimate for area under the plasma concentration-time curve extrapolated to infinity was 0.96 (100 mg; high-fat/fasted), 1.19-1.24 (500 mg; high-fat/fasted), and 1.22 (500 mg; low-fat/fasted). Fedratinib 500 mg attained peak plasma concentration 4 hours after a high-fat breakfast and 2-2.5 hours after a low-fat breakfast or under fasted conditions; terminal half-life was 76-88 hours (fasted) and 73-78 hours (fed). The most frequent adverse events were mild gastrointestinal toxicities, the incidence of which decreased following a high-fat breakfast compared with both fasted and low-fat breakfast conditions (17%, 67%, and 59% of subjects, respectively, in ALI13451). In conclusion, food intake had minimal impact on the PKs of fedratinib, and the tolerability of this drug was improved when taken following a high-fat breakfast.",2015,"The most frequent adverse events were mild gastrointestinal toxicities, the incidence of which decreased following a high-fat breakfast compared with both fasted and low-fat breakfast conditions (17%, 67%, and 59% of subjects, respectively, in ALI13451).","['patients with myelofibrosis', 'healthy male subjects', 'healthy volunteers']","['I studies (FED12258: 100\u2009mg or 500\u2009mg under fasted or fed [high-fat breakfast] conditions', '500\u2009mg under fasted or fed [low- or high-fat breakfast', 'JAK2-selective inhibitor fedratinib (SAR302503', 'ALI13451']","['bioavailability and tolerability', 'mild gastrointestinal toxicities', 'pharmacokinetics (PKs) and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001815', 'cui_str': 'Idiopathic Myelofibrosis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C4552074', 'cui_str': 'SAR302503'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0426207,"The most frequent adverse events were mild gastrointestinal toxicities, the incidence of which decreased following a high-fat breakfast compared with both fasted and low-fat breakfast conditions (17%, 67%, and 59% of subjects, respectively, in ALI13451).","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Sanofi Clinical and Exploratory Pharmacology, Bridgewater, NJ, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi Disposition, Safety and Animal Research, Bridgewater, NJ, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Sanofi Disposition, Safety and Animal Research, Bridgewater, NJ, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Shamiyeh', 'Affiliation': 'Sanofi Clinical and Exploratory Pharmacology, Bridgewater, NJ, USA.'}, {'ForeName': 'Jianyun', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Sanofi Clinical and Exploratory Pharmacology, Bridgewater, NJ, USA.'}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'von Moltke', 'Affiliation': 'Sanofi Clinical and Exploratory Pharmacology, Cambridge, MA, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Smith', 'Affiliation': 'Volunteer Research Group, University of Tennessee Medical Center, Knoxville, TN, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.161']
37,22392526,"Changes in parameters of bone metabolism in postmenopausal women following a 12-month intervention period using dairy products enriched with calcium, vitamin D, and phylloquinone (vitamin K(1)) or menaquinone-7 (vitamin K (2)): the Postmenopausal Health Study II.","The objective of the present study was to examine the effect of dairy products enriched with calcium, vitamin D(3), and phylloquinone (vitamin K(1)) or menaquinone-7 (vitamin K(2)) on parameters of bone metabolism in postmenopausal women following a 12-month intervention. Postmenopausal women were divided into three intervention groups and a control group (CG). All three intervention groups attended biweekly sessions and received fortified dairy products providing daily 800 mg of calcium and 10 μg of vitamin D(3) (CaD). Furthermore, in two of the three intervention groups the dairy products were also enriched with vitamin K, providing daily 100 μg of either phylloquinone (CaDK1) or menaquinone-7 (CaDK2). The increase observed for serum 25(OH)D levels in all intervention groups and the increase observed for serum IGF-I levels in the CaDK2 group differed significantly compared to the changes observed in CG (P = 0.010 and P = 0.028, respectively). Furthermore, both the CaDK1 and CaDK2 groups had a significantly lower mean serum undercarboxylated osteocalcin to osteocalcin ratio and urine deoxypyridinoline levels at follow-up compared to the CaD and CG groups (P = 0.001 and P = 0.047, respectively). Significant increases in total-body BMD were observed in all intervention groups compared to CG (P < 0.05), while significant increases in lumbar spine BMD were observed only for CaDK1 and CaDK2 compared to CG (P < 0.05) after controlling for changes in serum 25(OH)D levels and dietary calcium intake. In conclusion, the present study revealed more favorable changes in bone metabolism and bone mass indices for the two vitamin K-supplemented groups, mainly reflected in the suppression of serum levels of bone remodeling indices and in the more positive changes in lumbar spine BMD for these two study groups.",2012,Significant increases in total-body BMD were observed in all intervention groups compared to CG (P ,"['postmenopausal women', 'Postmenopausal women', 'postmenopausal women following a 12-month intervention']","['fortified dairy products providing daily 800\xa0mg of calcium and 10\xa0μg of vitamin D(3) (CaD', 'calcium, vitamin D, and phylloquinone (vitamin K(1)) or menaquinone-7 (vitamin K (2', 'phylloquinone (CaDK1) or menaquinone-7 (CaDK2', 'dairy products enriched with calcium, vitamin D(3), and phylloquinone (vitamin K(1)) or menaquinone-7 (vitamin K(2', 'control group (CG']","['bone metabolism and bone mass indices', 'bone metabolism', 'total-body BMD', 'lumbar spine BMD', 'serum IGF-I levels', 'mean serum undercarboxylated osteocalcin to osteocalcin ratio and urine deoxypyridinoline levels', 'serum 25(OH)D levels and dietary calcium intake', 'serum 25(OH)D levels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0031862', 'cui_str': 'phytonadione'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1318673', 'cui_str': 'Urine deoxypyridinoline measurement'}, {'cui': 'C0006726', 'cui_str': 'Calcium, Dietary'}]",,0.0286718,Significant increases in total-body BMD were observed in all intervention groups compared to CG (P ,"[{'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Kanellakis', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, Kallithea, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Moschonis', 'Affiliation': ''}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Tenta', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schaafsma', 'Affiliation': ''}, {'ForeName': 'Ellen G H M', 'Initials': 'EG', 'LastName': 'van den Heuvel', 'Affiliation': ''}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Papaioannou', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Lyritis', 'Affiliation': ''}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': ''}]",Calcified tissue international,['10.1007/s00223-012-9571-z']
38,21831503,RETRACTED: Clomiphene citrate versus tamoxifen for ovulation induction in women with PCOS: a prospective randomized trial,,2011,"Serum E(2), on the day of hCG administration, was significantly higher in the clomiphene group (p<0.0001).","['371 PCOS patients', 'anovulatory subfertile women with PCOS', 'women with PCOS']","['Clomiphene citrate versus tamoxifen', 'tamoxifen', 'TMX', 'CC', 'clomiphene', 'Clomiphene citrate', 'CC versus TMX', 'Tamoxifen']","['Ovulation', 'number of growing and mature follicles, serum E(2', 'Serum E(2', 'number of stimulated follicles reaching ≥ 16 mm diameter', 'Pregnancy', 'serum progesterone (ng/ml) and endometrial thickness, the occurrence of pregnancy and miscarriage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}]","[{'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",371.0,0.108569,"Serum E(2), on the day of hCG administration, was significantly higher in the clomiphene group (p<0.0001).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: abadawy@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Gibreal', 'Affiliation': 'Department of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2011.07.015']
39,17640058,"Polymorphisms in PTGS1, PTGS2 and IL-10 do not influence colorectal adenoma recurrence in the context of a randomized aspirin intervention trial.","Regular use of aspirin and other nonsteroidal antiinflammatory drugs reduces both the development of colorectal neoplasia and recurrence of colorectal adenoma (CRA). Modulation of the effects of aspirin by genetic factors has been reported, potentially allowing targeting of treatment to individuals most likely to gain benefit. Prostaglandin H synthase 1 (PTGS1) and PTGS2 are key enzymes in prostaglandin synthesis and are inhibited by aspirin, whilst interleukin-10 (IL-10) is an important antiinflammatory cytokine. We investigated whether functional genetic polymorphisms in the PTGS1, PTGS2 and IL-10 genes influence CRA recurrence in individuals participating in a randomized aspirin intervention trial. DNA was available for genotyping from 546 patients who received aspirin (300 mg daily) or placebo for a mean 41-months' duration. Homozygote carriers of variant alleles for the PTGS1 50C>T, PTGS2 -765G>C and IL-10 -592C>A polymorphisms did not have a significantly altered risk of CRA recurrence (relative risk [RR]=0.91; 95% confidence interval [CI]: 0.14-6.07, RR=1.32; 95% CI: 0.66-2.62 and RR=1.24; 95% CI: 0.74-2.07, respectively). There were also no significant interactions between aspirin intervention and genotype in determining recurrence risk. These data indicate that these polymorphisms are unlikely to influence CRA recurrence and cannot be used to identify individuals who derive benefit from aspirin intervention.",2007,"Homozygote carriers of variant alleles for the PTGS1 50C>T, PTGS2","['individuals participating in a randomized aspirin intervention trial', '546 patients who received']","['PTGS2', 'placebo', 'PTGS1, PTGS2 and IL-10', 'PTGS1, PTGS2', 'Prostaglandin H synthase 1 (PTGS1) and PTGS2', 'aspirin']","['recurrence risk', 'colorectal adenoma recurrence', 'colorectal neoplasia and recurrence of colorectal adenoma (CRA', 'CRA recurrence']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0389003', 'cui_str': 'Cyclo-Oxygenase I'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",546.0,0.273135,"Homozygote carriers of variant alleles for the PTGS1 50C>T, PTGS2","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Hubner', 'Affiliation': 'Section of Cancer Genetics, Institute of Cancer Research, Sutton SM2 5NG, United Kingdom.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Muir', 'Affiliation': ""Division of Epidemiology and Public Health Medical School, University of Nottingham, Queen's Medical Centre, Nottingham NG7 2UH, United Kingdom.""}, {'ForeName': 'Jo-Fen', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': ""Division of Epidemiology and Public Health Medical School, University of Nottingham, Queen's Medical Centre, Nottingham NG7 2UH, United Kingdom.""}, {'ForeName': 'Richard F A', 'Initials': 'RFA', 'LastName': 'Logan', 'Affiliation': ""Division of Epidemiology and Public Health Medical School, University of Nottingham, Queen's Medical Centre, Nottingham NG7 2UH, United Kingdom.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Grainge', 'Affiliation': ""Division of Epidemiology and Public Health Medical School, University of Nottingham, Queen's Medical Centre, Nottingham NG7 2UH, United Kingdom.""}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Houlston', 'Affiliation': 'Section of Cancer Genetics, Institute of Cancer Research, Sutton SM2 5NG, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of cancer,['10.1002/ijc.22942']
40,24165976,"A randomized, placebo-controlled study of the pharmacokinetics, pharmacodynamics, and tolerability of the oral JAK2 inhibitor fedratinib (SAR302503) in healthy volunteers.","Fedratinib (SAR302503/TG101348) is a Janus kinase 2 (JAK2)-selective inhibitor in clinical development for the treatment of myelofibrosis. In this randomized, placebo-controlled, Phase 1 study, the pharmacokinetics, pharmacodynamics and tolerability of ascending single doses of fedratinib (10-680 mg) were assessed in healthy male subjects. Fedratinib was rapidly absorbed, with peak plasma concentration observed approximately 3 hours after dosing. The mean terminal half-life of fedratinib was approximately 67 hours, which was unaffected by dose. Fedratinib exposure increased in a greater than dose-proportional manner. Suppression of signal transducer and activator of transcription 3 (STAT3) phosphorylation, indicative of JAK2 inhibition, was observed at 3 hours post-dose for subjects in the 300, 500, and 680 mg groups, with the level of suppression increasing with dose. The relationship between fedratinib exposure and suppression of STAT3 phosphorylation was described using an inhibitory effect sigmoid Emax model, with an EC50 of 1,210 ng/mL in healthy subjects. The most common adverse events were mild gastrointestinal toxicities.",2014,"Suppression of signal transducer and activator of transcription 3 (STAT3) phosphorylation, indicative of JAK2 inhibition, was observed at 3 hours post-dose for subjects in the 300, 500, and 680 mg groups, with the level of suppression increasing with dose.","['healthy subjects', 'healthy male subjects', 'healthy volunteers']","['fedratinib', 'oral JAK2 inhibitor fedratinib (SAR302503', 'placebo']","['mild gastrointestinal toxicities', 'mean terminal half-life of fedratinib', 'pharmacokinetics, pharmacodynamics and tolerability', 'peak plasma concentration', 'Fedratinib exposure']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4552074', 'cui_str': 'SAR302503'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0445106,"Suppression of signal transducer and activator of transcription 3 (STAT3) phosphorylation, indicative of JAK2 inhibition, was observed at 3 hours post-dose for subjects in the 300, 500, and 680 mg groups, with the level of suppression increasing with dose.","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Sanofi Clinical and Exploratory Pharmacology, Bridgewater, NJ, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Shamiyeh', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Jian Y', 'Initials': 'JY', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'von Moltke', 'Affiliation': ''}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Smith', 'Affiliation': ''}]",Journal of clinical pharmacology,['10.1002/jcph.218']
41,21880023,Does exercise during pregnancy prevent postnatal depression? A randomized controlled trial.,"OBJECTIVE


To study whether exercise during pregnancy reduces the risk of postnatal depression.
DESIGN


Randomized controlled trial.
SETTING


Trondheim and Stavanger University Hospitals, Norway.
POPULATION AND SAMPLE


Eight hundred and fifty-five pregnant women were randomized to intervention or control groups.
METHODS


The intervention was a 12 week exercise program, including aerobic and strengthening exercises, conducted between week 20 and 36 of pregnancy. One weekly group session was led by physiotherapists, and home exercises were encouraged twice a week. Control women received regular antenatal care.
MAIN OUTCOME MEASURES


Edinburgh Postnatal Depression Scale (EPDS) completed three months after birth. Scores of 10 or more and 13 or more suggested probable minor and major depression, respectively.
RESULTS


Fourteen of 379 (3.7%) women in the intervention group and 17 of 340 (5.0%) in the control group had an EPDS score of ≥10 (p=0.46), and four of 379 (1.2%) women in the intervention group and eight of 340 (2.4%) in the control group had an EPDS score of ≥13 (p=0.25). Among women who did not exercise prior to pregnancy, two of 100 (2.0%) women in the intervention group and nine of 95 (9.5%) in the control group had an EPDS score of ≥10 (p=0.03).
CONCLUSIONS


We did not find a lower prevalence of high EPDS scores among women randomized to regular exercise during pregnancy compared with the control group. However, a subgroup of women in the intervention group who did not exercise regularly prior to pregnancy had a reduced risk of postnatal depression.",2012,We did not find a lower prevalence of high EPDS scores among women randomized to regular exercise during pregnancy compared with the control group.,"['Eight hundred and fifty-five pregnant women', 'Trondheim and Stavanger University Hospitals, Norway']","['regular antenatal care', 'regular exercise']","['high EPDS scores', 'EPDS score', 'Edinburgh Postnatal Depression Scale (EPDS', 'risk of postnatal depression']","[{'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}]",855.0,0.181092,We did not find a lower prevalence of high EPDS scores among women randomized to regular exercise during pregnancy compared with the control group.,"[{'ForeName': 'Kristian M', 'Initials': 'KM', 'LastName': 'Songøygard', 'Affiliation': ""Laboratory Medicine, Children's and Women's Health.""}, {'ForeName': 'Signe N', 'Initials': 'SN', 'LastName': 'Stafne', 'Affiliation': 'Public Health and General Practice, Norwegian University of Science and Technology, Trondheim.'}, {'ForeName': 'Kari Anne I', 'Initials': 'KAI', 'LastName': 'Evensen', 'Affiliation': 'Public Health and General Practice, Norwegian University of Science and Technology, Trondheim.'}, {'ForeName': 'Kjell Å', 'Initials': 'KÅ', 'LastName': 'Salvesen', 'Affiliation': ""Laboratory Medicine, Children's and Women's Health.""}, {'ForeName': 'Torstein', 'Initials': 'T', 'LastName': 'Vik', 'Affiliation': ""Laboratory Medicine, Children's and Women's Health.""}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Mørkved', 'Affiliation': 'Public Health and General Practice, Norwegian University of Science and Technology, Trondheim.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/j.1600-0412.2011.01262.x']
42,26252788,A phase 2 randomized dose-ranging study of the JAK2-selective inhibitor fedratinib (SAR302503) in patients with myelofibrosis.,"In this phase 2 open-label randomized study, 31 patients with intermediate-2 or high-risk myelofibrosis received fedratinib 300, 400 or 500 mg once daily in consecutive 4-week cycles. Mean spleen volume reductions at 12 weeks (primary end point) were 30.3% (300 mg), 33.1% (400 mg) and 43.3% (500 mg). Spleen response rates (patients achieving ⩾35% spleen reduction) at 12/24 weeks were 30%/30% (300 mg), 50%/60% (400 mg) and 64%/55% (500 mg), respectively. By 4 weeks, improvements in myelofibrosis (MF)-associated symptoms were observed. At 48 weeks, 68% of patients remained on fedratinib and 16% had discontinued because of adverse events (AEs). Common grade 3/4 AEs were anemia (58%), fatigue (13%), diarrhea (13%), vomiting (10%) and nausea (6%). Serious AEs included one case of reversible hepatic failure and one case of Wernicke's encephalopathy (after analysis cutoff). Fedratinib treatment led to reduced STAT3 phosphorylation but no meaningful change in JAK2V617F allele burden. Significant modulation (P<0.05, adjusted for multiple comparisons) of 28 cytokines was observed, many of which correlated with spleen reduction. These data confirm the clinical activity of fedratinib in MF. After the analysis cutoff date, additional reports of Wernicke's encephalopathy in other fedratinib trials led to discontinuation of the sponsored clinical development program.",2015,Fedratinib treatment led to reduced STAT3 phosphorylation but no meaningful change in JAK2V617F allele burden.,"['patients with myelofibrosis', '31 patients with intermediate-2 or high-risk myelofibrosis']",['JAK2-selective inhibitor fedratinib (SAR302503'],"['vomiting', 'diarrhea', 'nausea', 'Mean spleen volume reductions', 'anemia', 'myelofibrosis (MF)-associated symptoms', 'Spleen response rates', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001815', 'cui_str': 'Idiopathic Myelofibrosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C4552074', 'cui_str': 'SAR302503'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0001815', 'cui_str': 'Idiopathic Myelofibrosis'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",31.0,0.086606,Fedratinib treatment led to reduced STAT3 phosphorylation but no meaningful change in JAK2V617F allele burden.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pardanani', 'Affiliation': 'Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tefferi', 'Affiliation': 'Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jamieson', 'Affiliation': 'Department of Medicine, UCSD Moores Cancer Centre, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'N Y', 'Initials': 'NY', 'LastName': 'Gabrail', 'Affiliation': 'Gabrail Cancer Center, Canton, OH, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebedinsky', 'Affiliation': 'Sanofi Oncology, Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Sanofi Oncology, Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Sanofi Oncology, Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi Oncology, Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Sanofi Oncology, Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Talpaz', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Comprehensive Cancer Center, The University of Michigan Hospital and Health Systems, Ann Arbor, MI, USA.'}]",Blood cancer journal,['10.1038/bcj.2015.63']
43,22289649,"Low-dose menaquinone-7 supplementation improved extra-hepatic vitamin K status, but had no effect on thrombin generation in healthy subjects.","Vitamin K is required for the carboxylation of Gla-proteins in the liver (coagulation factors) and extra-hepatic tissues, such as bone (osteocalcin, OC), and arterial wall (matrix Gla-protein, MGP). Although the coagulation factors are essentially fully carboxylated under normal conditions, 10-40 % of OC and MGP remains undercarboxylated. We were therefore interested to study the dose-response effects of extra intake of menaquinones on the carboxylation of the extra-hepatic Gla-proteins. A total of forty-two healthy Dutch men and women aged between 18 and 45 years were randomised into seven groups to receive: placebo capsules or menaquinone-7 (MK-7) capsules at a daily dose of 10, 20, 45, 90, 180 or 360 μg. Circulating uncarboxylated OC (ucOC), carboxylated OC (cOC) and desphospho-uncarboxylated MGP were measured by ELISA. The ucOC:cOC ratio was calculated from circulating ucOC and cOC values. Endogenous thrombin potential and peak height were determined by calibrated automated thrombography. To increase the statistical power, we collapsed the treatment groups into three dosage groups: placebo, low-dose supplementation (doses below RDA, Commission Directive 2008/100/EC), and high-dose supplementation (doses around RDA, Commission Directive 2008/100/EC). MK-7 supplementation at doses in the order of the RDA (Commission Directive 2008/100/EC) increased the carboxylation of circulating OC and MGP. No adverse effects on thrombin generation were observed. Extra MK-7 intake at nutritional doses around the RDA (Commission Directive 2008/100/EC) improved the carboxylation of the extra-hepatic vitamin K-dependent proteins. Whether this improvement contributes to public health, i.e. increasing the protection against age-related diseases needs further investigation in specifically designed intervention trials.",2012,No adverse effects on thrombin generation were observed.,"['A total of forty-two healthy Dutch men and women aged between 18 and 45 years', 'healthy subjects']","['menaquinone-7 supplementation', 'placebo capsules or menaquinone-7 (MK-7) capsules', 'Vitamin K', 'placebo, low-dose supplementation (doses below RDA, Commission Directive 2008/100/EC), and high-dose supplementation (doses around RDA, Commission Directive 2008/100/EC). MK-7 supplementation']","['thrombin generation', 'Endogenous thrombin potential and peak height', 'extra-hepatic vitamin K status', 'Circulating uncarboxylated OC (ucOC), carboxylated OC (cOC) and desphospho-uncarboxylated MGP']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",42.0,0.0295161,No adverse effects on thrombin generation were observed.,"[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Theuwissen', 'Affiliation': 'VitaK & Cardiovascular Research Institute Maastricht, Maastricht University, Oxfordlaan 70, Maastricht, The Netherlands. e.theuwissen@vitak.com'}, {'ForeName': 'Ellen C', 'Initials': 'EC', 'LastName': 'Cranenburg', 'Affiliation': ''}, {'ForeName': 'Marjo H', 'Initials': 'MH', 'LastName': 'Knapen', 'Affiliation': ''}, {'ForeName': 'Elke J', 'Initials': 'EJ', 'LastName': 'Magdeleyns', 'Affiliation': ''}, {'ForeName': 'Kirsten J', 'Initials': 'KJ', 'LastName': 'Teunissen', 'Affiliation': ''}, {'ForeName': 'Leon J', 'Initials': 'LJ', 'LastName': 'Schurgers', 'Affiliation': ''}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Smit', 'Affiliation': ''}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Vermeer', 'Affiliation': ''}]",The British journal of nutrition,['10.1017/S0007114511007185']
44,31444617,"Population pharmacokinetics of fedratinib in patients with myelofibrosis, polycythemia vera, and essential thrombocythemia.","PURPOSE


Fedratinib (SAR302503, TG101348) is an orally administered Janus kinase (JAK) 2-selective inhibitor that is being developed for the treatment of patients with myelofibrosis (MF). The objectives of this analysis were to develop a population pharmacokinetic (PK) model to characterize fedratinib concentration-time profiles in patients with MF, polycythemia vera (PV) and essential thrombocythemia (ET) following oral fedratinib administration; and to investigate the effects of selected covariates on fedratinib PK parameters.
METHODS


Nonlinear mixed effects modeling was employed in developing a population PK model for fedratinib. Intensive or sparse fedratinib concentration data collected in adult subjects with MF, PV or ET from six studies were pooled, and a total of 452 subjects and 3442 plasma concentration observations were included in the final model.
RESULTS


Fedratinib PK in patients with MF/PV/ET was adequately described by a two-compartment structural PK model with first-order absorption incorporating a lag time and first-order elimination. Following oral administration, fedratinib undergoes biphasic disposition and exhibits linear, time-invariant PK at doses of 200 mg and above. Compared to MF/ET patients, PV patients had higher apparent clearance (CL/F) and apparent central volume of distribution. Creatinine clearance was a statistically significant covariate on CL/F, and patients with mild and moderate renal impairment had 10% and 37% increases in fedratinib exposure as compared to patients with normal renal function. No clinically meaningful effect on fedratinib exposure was observed regarding age, body weight, sex, race and liver function.
CONCLUSIONS


These results should serve as the basis for dose adjustment of fedratinib for special populations.",2019,"No clinically meaningful effect on fedratinib exposure was observed regarding age, body weight, sex, race and liver function.
","['patients with MF, polycythemia vera (PV) and essential thrombocythemia (ET) following oral fedratinib administration', 'patients with myelofibrosis, polycythemia vera, and essential thrombocythemia', 'adult subjects with MF, PV or ET from six studies were pooled, and a total of 452 subjects and 3442 plasma concentration observations were included in the final model', 'patients with myelofibrosis (MF']",['Janus kinase (JAK'],"['Creatinine clearance', 'apparent clearance (CL/F) and apparent central volume of distribution', 'moderate renal impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001815', 'cui_str': 'Myelosclerosis with myeloid metaplasia'}, {'cui': 'C0032463', 'cui_str': 'Polycythemia vera'}, {'cui': 'C0040028', 'cui_str': 'Essential thrombocythemia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0597721', 'cui_str': 'JAK Kinases'}]","[{'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",452.0,0.0207016,"No clinically meaningful effect on fedratinib exposure was observed regarding age, body weight, sex, race and liver function.
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA. yali@celgene.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03929-9']
45,23062766,The effect of menaquinone-7 supplementation on circulating species of matrix Gla protein.,"OBJECTIVE


To investigate whether menaquinone-7 (MK-7) supplementation increases carboxylation of MGP.
DESIGN


A randomized, double-blind, placebo-controlled trial was performed. Sixty participants (40-65 y) were randomly allocated to supplementation of 180 μg/d, 360 μg/d of MK-7 or placebo during 12 weeks. At baseline, after 4 and 12 weeks, desphospho-uncarboxylated MGP (dp-ucMGP), desphospho-carboxylated MGP (dp-cMGP) and total uncarboxylated MGP (t-ucMGP) were measured by ELISA techniques. Furthermore, the ratio of uncarboxylated osteocalcin (ucOC) to carboxylated osteocalcin (cOC) was used as proxy of vitamin K status and various cardiovascular risk factors were measured.
RESULTS


Dp-ucMGP decreased significantly and dose-dependently in the 180 μg and 360 μg MK-7 supplementation groups (P time*treatment < 0.001) after 12 weeks, by 31% and 46% respectively, while dp-ucMGP levels remained unchanged after placebo treatment. The osteocalcin ratio also decreased significantly after 12-week supplementation with 180 μg (60%) and 360 μg (74%) MK-7 (P time*treatment < 0.001), while levels remained unchanged after placebo treatment. These results indicate improved vitamin K status and good compliance to the study treatment. Changes over time of dp-cMGP (p = 0.42) and t-ucMGP (p = 0.23) levels did not differ between treatment arms. Other cardiovascular risk factors did not differ between treatments arms.
CONCLUSIONS


Menaquinone supplementation dose-dependently decreases dp-ucMGP concentrations, but does not affect other MGP species. Dp-ucMGP may serve as a non-invasive marker of vitamin K status.",2012,Changes over time of dp-cMGP (p = 0.42) and t-ucMGP (p = 0.23) levels did not differ between treatment arms.,['Sixty participants (40-65 y'],"['placebo', 'menaquinone-7 supplementation', 'menaquinone-7 (MK-7) supplementation', 'desphospho-uncarboxylated MGP (dp-ucMGP), desphospho-carboxylated MGP (dp-cMGP) and total uncarboxylated MGP (t-ucMGP', 'MK-7 or placebo', 'MK-7']","['vitamin K status', 'ratio of uncarboxylated osteocalcin (ucOC) to carboxylated osteocalcin (cOC', 'dp-ucMGP concentrations', 'vitamin K status and various cardiovascular risk factors', 'circulating species of matrix Gla protein', 'osteocalcin ratio', 'cardiovascular risk factors', 'dp-ucMGP levels', 'Changes over time of dp-cMGP']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0065752', 'cui_str': 'matrix gamma-carboxyglutamic acid protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",60.0,0.100567,Changes over time of dp-cMGP (p = 0.42) and t-ucMGP (p = 0.23) levels did not differ between treatment arms.,"[{'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Dalmeijer', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. G.W.Dalmeijer@umcutrecht.nl'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Magdeleyns', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vermeer', 'Affiliation': ''}, {'ForeName': 'J W J', 'Initials': 'JW', 'LastName': 'Beulens', 'Affiliation': ''}]",Atherosclerosis,['10.1016/j.atherosclerosis.2012.09.019']
46,20177349,Dietary vitamin K2 supplement improves bone status after lung and heart transplantation.,"BACKGROUND


Osteoporosis is a problem after transplantation. Studies since the last year indicate that vitamin K plays a role in optimal bone health. The aim of this randomized, double blind, prospective longitudinal study was to investigate the effect of a dietary supplement with vitamin K2 (180 microg menakinon-7) on bone mass, the first year after lung and heart transplantation.
METHODS


After preoperative baseline investigation of bone mass and bone-related biochemistry, 35 lung and 59 heart recipients were postoperatively randomized to vitamin K2 or placebo and reinvestigated the following year.
RESULTS


In all recipients, 1 year after solid organ transplantation, the difference between vitamin K2 and placebo for the lumbar spine (L2-L4) bone mineral density (BMD) was 0.028 (SE 0.014) g/cm(2), P=0.055 and for L2 to L4 bone mineral content was 1.33 (SE 1.91) g/cm(2) (P=0.5). In lung recipients separately, the difference for bone mineral content was 3.39 g (SE 1.65), P=0.048 and in heart recipients 0.45 (SE 0.02) g, P=0.9 after controlling for baseline measures. In a forward stepwise linear regression analysis fitted to model differences in the L2 to L4 BMD, controlled for possible confounding variables (including use of bisphosphonate), and the only significant predictors were organ (B=-0.065 g/cm(2), P<0.001) and vitamin K2 (B=0.034 g/cm(2), P=0.019). Insufficient vitamin D status was common, and the parathyroid hormone was highest in the K2 group indicating a higher need for vitamin D.
CONCLUSIONS


One year of vitamin K2 supplement suggest a favorable effect on lumbar spine BMD with different response in lung and heart recipients. Vitamin D status should receive more attention.",2010,"In all recipients, 1 year after solid organ transplantation, the difference between vitamin K2 and placebo for the lumbar spine (L2-L4) bone mineral density (BMD) was 0.028","['lung and heart recipients', '35 lung and 59 heart recipients', 'after lung and heart transplantation']","['vitamin K2 supplement', 'vitamin K2 and placebo', 'dietary supplement with vitamin K2 (180 microg menakinon-7', 'vitamin K2 or placebo', 'Dietary vitamin K2 supplement', 'g/cm(2']","['bone status', 'lumbar spine BMD', 'bone mineral content', 'parathyroid hormone', 'L2 to L4 bone mineral content', 'lumbar spine (L2-L4) bone mineral density (BMD']","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",,0.287275,"In all recipients, 1 year after solid organ transplantation, the difference between vitamin K2 and placebo for the lumbar spine (L2-L4) bone mineral density (BMD) was 0.028","[{'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Forli', 'Affiliation': 'Medical Department, Rikshospitalet, Oslo University Hospital, Oslo, Norway. liv.forli@rikshospitalet.no'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bollerslev', 'Affiliation': ''}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Simonsen', 'Affiliation': ''}, {'ForeName': 'Gunhild A', 'Initials': 'GA', 'LastName': 'Isaksen', 'Affiliation': ''}, {'ForeName': 'Kari E', 'Initials': 'KE', 'LastName': 'Kvamsdal', 'Affiliation': ''}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Godang', 'Affiliation': ''}, {'ForeName': 'Gaut', 'Initials': 'G', 'LastName': 'Gadeholt', 'Affiliation': ''}, {'ForeName': 'Are H', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': ''}, {'ForeName': 'Oystein', 'Initials': 'O', 'LastName': 'Bjortuft', 'Affiliation': ''}]",Transplantation,['10.1097/TP.0b013e3181c46b69']
47,19450370,The effect of menaquinone-7 (vitamin K2) supplementation on osteocalcin carboxylation in healthy prepubertal children.,"Vitamin K contributes to bone health, probably through its role as cofactor in the carboxylation of osteocalcin. Intervention studies in adults have demonstrated that markedly higher osteocalcin carboxylation is obtained by intakes of vitamin K well above the current recommended dietary intake. However, the relationship between increased vitamin K2 intake and enhanced osteocalcin carboxylation has never been shown in healthy children. The objective was to study the effect of 45 microg menaquinone-7 (MK-7; one of the vitamin K2 species) on the circulating levels of undercarboxylated osteocalcin (ucOC) and carboxylated osteocalcin (cOC) in healthy prepubertal children. We hypothesised that MK-7 supplementation will reduce the ucOC:cOC ratio (UCR), indicating an improved vitamin K status. The present study is a double-blind randomised placebo-controlled trial examining the effect of 8 weeks MK-7 supplementation on the carboxylation of osteocalcin in healthy children (n 55). Serum levels of ucOC, cOC and MK-7 were measured at baseline and after 8 weeks, together with bone markers and coagulation parameters. The UCR was used as an indicator of vitamin K status. In the MK-7-supplemented group (n 28), the circulating concentration of inactive ucOC reduced and the UCR improved whereas the concentration of MK-7 increased. Within the placebo group, ucOC, cOC, UCR and MK-7 did not significantly change over time. In both groups, bone markers and coagulation parameters remained constant over time. These findings demonstrate that in healthy, prepubertal children, modest supplementation with MK-7 increases circulating concentrations of MK-7 and increases osteocalcin carboxylation.",2009,"Within the placebo group, ucOC, cOC, UCR and MK-7 did not significantly change over time.","['healthy children (n 55', 'healthy children', 'healthy prepubertal children']","['45 microg menaquinone-7 (MK-7', 'placebo', 'Vitamin K', 'MK-7 supplementation', 'menaquinone-7 (vitamin K2) supplementation']","['ucOC, cOC, UCR and MK-7', 'circulating concentration of inactive ucOC', 'bone markers and coagulation parameters', 'vitamin K2 intake', 'carboxylation of osteocalcin', 'ucOC:cOC ratio (UCR', 'circulating levels of undercarboxylated osteocalcin (ucOC) and carboxylated osteocalcin (cOC', 'Serum levels of ucOC, cOC and MK-7']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.157125,"Within the placebo group, ucOC, cOC, UCR and MK-7 did not significantly change over time.","[{'ForeName': 'Marieke J H', 'Initials': 'MJ', 'LastName': 'van Summeren', 'Affiliation': 'Department of Paediatrics, University Medical Centre Utrecht, PO Box 85090, 3508 AB Utrecht, The Netherlands. m.j.h.vansummeren@umcutrecht.nl'}, {'ForeName': 'Lavienja A J L M', 'Initials': 'LA', 'LastName': 'Braam', 'Affiliation': ''}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Lilien', 'Affiliation': ''}, {'ForeName': 'Leon J', 'Initials': 'LJ', 'LastName': 'Schurgers', 'Affiliation': ''}, {'ForeName': 'Wietse', 'Initials': 'W', 'LastName': 'Kuis', 'Affiliation': ''}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Vermeer', 'Affiliation': ''}]",The British journal of nutrition,['10.1017/S0007114509382100']
48,9737352,Menatetrenone ameliorates osteopenia in disuse-affected limbs of vitamin D- and K-deficient stroke patients.,"Significant reduction in bone mineral density (BMD) occurs in stroke patients on the hemiplegic and contralateral sides, correlating with the degree of paralysis and vitamin D and K deficiency due to malnutrition, and increasing the risk of hip fracture. We evaluated the efficacy of vitamin K2 (menatetrenone: menaquinone-4; MK-4) in maintaining BMD by comparing serum biochemical indices of bone metabolism between treated and untreated patients. In a random and prospective study, of 108 hemiplegic patients following stroke, 54 received 45 mg menatetrenone daily (MK-4 group, n = 54) for 12 months, and the remaining 54 (untreatment group) did not. Nine patients excluded from the study. The BMD in the second metacarpals and serum indices of bone metabolism were determined. BMD on the hemiplegic side increased by 4.3% in the MK-4 group and decreased by 4.7% in the untreated group (p < 0.0001), while BMD on the intact side decreased by 0.9% in the MK-4 group and by 2.7% in the untreated group (p < 0.0001). At baseline, patients of both groups showed vitamin D and K1 deficiencies, high serum levels of ionized calcium, pyridinoline cross-linked carboxyterminal telopeptide of type I collagen (ICTP), and low levels of parathyroid hormones (PTH) and bone Gla proteins (BGP), indicating that immobilization-induced hypercalcemia inhibits renal synthesis of 1, 25-dihydroxyvitamin D (1, 25-[OH]2D) and compensatory PTH secretion. Both vitamins K1 and K2 increased by 97.6% and 666.9%, respectively, in the MK-4 group. Correspondingly, a significant increase in BGP and decreases in both ICTP and calcium were observed in the MK-4 group, in association with a simultaneous increase in both PTH and 1, 25-[OH]2D. One patient in the untreated group suffered from a hip fracture, compared with none in the MK-4 group. The treatment with MK-4 can increase the BMD of disused and vitamin D- and K-deficient hemiplegic bone by increasing the vitamin K concentration, and it also can decrease calcium levels through inhibition of bone resorption, resulting in an increase in 1, 25-[OH]2D concentration.",1998,"BMD on the hemiplegic side increased by 4.3% in the MK-4 group and decreased by 4.7% in the untreated group (p < 0.0001), while BMD on the intact side decreased by 0.9% in the MK-4 group and by 2.7% in the untreated group (p < 0.0001).","['ameliorates osteopenia in disuse-affected limbs of vitamin D- and K-deficient stroke patients', 'Nine patients excluded from the study', 'stroke patients', '108 hemiplegic patients following stroke, 54 received', 'bone metabolism between treated and untreated patients']","['45 mg menatetrenone daily (MK-4', 'vitamin K2 (menatetrenone: menaquinone-4; MK-4', 'Menatetrenone', 'MK-4']","['hypercalcemia inhibits renal synthesis of 1, 25-dihydroxyvitamin D (1, 25-[OH]2D) and compensatory PTH secretion', 'BMD on the hemiplegic side', 'hip fracture', 'BMD on the intact side', 'BMD of disused and vitamin D- and K-deficient hemiplegic bone', 'ICTP and calcium', 'BGP', 'vitamin D and K1 deficiencies, high serum levels of ionized calcium, pyridinoline cross-linked carboxyterminal telopeptide of type I collagen (ICTP), and low levels of parathyroid hormones (PTH) and bone Gla proteins (BGP', 'bone mineral density (BMD', 'vitamins K1 and K2', 'serum indices of bone metabolism']","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0012328', 'cui_str': 'Dihydroxyvitamins D'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443755', 'cui_str': 'Pyridinoline cross-links (substance)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",108.0,0.0208391,"BMD on the hemiplegic side increased by 4.3% in the MK-4 group and decreased by 4.7% in the untreated group (p < 0.0001), while BMD on the intact side decreased by 0.9% in the MK-4 group and by 2.7% in the untreated group (p < 0.0001).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Neurology, Futase Social Insurance Hospital, Iizuka, Japan. y-sato@ktarn.or.jp'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kuno', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Oizumi', 'Affiliation': ''}]",Bone,[]
49,2012585,Creative novation behaviour therapy as a prophylactic treatment for cancer and coronary heart disease: Part II--Effects of treatment.,"In this article we consider the effectiveness of creative novation behaviour therapy in preventing cancer and coronary heart disease in disease-prone probands, and also its effectiveness in extending life for patients suffering from terminal cancer. In all cases, suitably matched controls are provided as part of the general methodology, and results are reported to testify to the effectiveness of the therapy, whether administered a long-term individual therapy, group therapy, or bibliotherapy plus short-term individual treatment. We also consider the negative effects of psychoanalysis on outcome.",1991,"In this article we consider the effectiveness of creative novation behaviour therapy in preventing cancer and coronary heart disease in disease-prone probands, and also its effectiveness in extending life for patients suffering from terminal cancer.","['patients suffering from terminal cancer', 'cancer and coronary heart disease']","['bibliotherapy plus short-term individual treatment', 'Creative novation behaviour therapy', 'creative novation behaviour therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]","[{'cui': 'C0005365', 'cui_str': 'Bibliotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]",[],,0.0148013,"In this article we consider the effectiveness of creative novation behaviour therapy in preventing cancer and coronary heart disease in disease-prone probands, and also its effectiveness in extending life for patients suffering from terminal cancer.","[{'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Eysenck', 'Affiliation': 'Department of Psychology, University of London, Denmark Hill, England.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Grossarth-Maticek', 'Affiliation': ''}]",Behaviour research and therapy,[]
50,7654164,Method of test administration as a factor in test validity: the use of a personality questionnaire in the prediction of cancer and coronary heart disease.,"This study examines the predictive accuracy of four different methods of administration of a questionnaire designed to predict cancer and coronary heart disease (CHD) in healthy probands. The method of administration uses the establishment of trust and the explanation of questions as variables in all four possible combinations, i.e. trust and explanation, trust only, explanation only, and neither, the prediction being that the combination of trust and explanation would produce the most accurate prediction, the treatment using neither the worst prediction, with methods using either trust alone or explanation alone intermediate. The criterion was the successful prediction of cancer and CHD. A total population of 3563 men and women was used, and followed up over 15 years, death certificates being used to establish cause of death. As predicted, the combination of trust and explanation did best, use of neither worst. Explanation seemed more important than trust, and the combination seemed to have a synergistic effect. It is apparent that method of administration had an important effect on the outcome of the experiment.",1995,"As predicted, the combination of trust and explanation did best, use of neither worst.","['A total population of 3563 men and women was used, and followed up over 15 years, death certificates being used to establish cause of death', 'healthy probands']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011066', 'cui_str': 'Death Certificates'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007465', 'cui_str': 'Cause of Death'}, {'cui': 'C0702111', 'cui_str': 'Proband (finding)'}]",[],[],3563.0,0.0279847,"As predicted, the combination of trust and explanation did best, use of neither worst.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Grossarth-Maticek', 'Affiliation': 'European Center for Peace and Development, University for Peace (United Nations), Denmark Hill, London, England.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Eysenck', 'Affiliation': ''}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Boyle', 'Affiliation': ''}]",Behaviour research and therapy,[]
51,32578037,Clinical Trial on Mindfulness with Family Caregivers for Patients with Cancer.,"To examine the effectiveness of a brief mindfulness-based interventions (MBIs) and educational interventions (EI) on self-efficacy and burden among family caregivers (FCs) of patients with cancer in Jordan. A quasi-experimental design was conducted. Two interventions were performed: the brief MBIs and the EIs were applied. A sampling of 138 FCs completed the study interventions. The FCs in the mindfulness group demonstrated a significant improvement in measures of self-efficacy and reduction in burden scores. Furthermore, in the EI group, only self-efficacy was significantly higher in the post-test. Burden reduction was significantly higher in the EI group than the mindfulness group. Appropriate supportive interventions should be directed to improve self-efficacy and reduce burden to assist FCs to carry out their crucial role in providing care for their patients.",2022,Burden reduction was significantly higher in the EI group than the mindfulness group.,"['138 FCs completed the study interventions', 'family caregivers (FCs) of patients with cancer in Jordan', 'Patients with Cancer']",['brief mindfulness-based interventions (MBIs) and educational interventions (EI'],"['self-efficacy and reduction in burden scores', 'Burden reduction', 'self-efficacy']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0118706,Burden reduction was significantly higher in the EI group than the mindfulness group.,"[{'ForeName': 'Muayyad M', 'Initials': 'MM', 'LastName': 'Ahmad', 'Affiliation': 'Clinical Nursing Department, School of Nursing, The University of Jordan, Amman, 11942, Jordan. mma4@ju.edu.jo.'}, {'ForeName': 'Laila I', 'Initials': 'LI', 'LastName': 'Al-Daken', 'Affiliation': 'College of Nursing, Sultan Qaboos University, Muscat, Oman.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01812-3']
52,1888324,Changes in degree of sclerosis as a function of prophylactic treatment in cancer-prone and CHD-prone probands.,"One-hundred and ninety-two probands were selected on the basis of personality questionnaires as being cancer-prone (100) or CHD-prone (92). They were then randomly divided into a control and a treatment group, the latter receiving a special kind of behaviour therapy attempting to change the personality patterns in the direction of a healthier, more autonomous personality. Follow-up after 10 and 13 years disclosed significantly lower death rates in probands receiving prophylactic treatment than in controls. Of special interest was the degree of sclerosis in the fundus of the eye, rateds on a 3-point scale. This was significantly higher prior to therapy in the CHD-prone group than in the cancer-prone group. Treatment reduced the degree of sclerosis, particularly in the CHD group; lack of treatment was followed by an increase in sclerosis. Similar but less marked changes were found in the cancer-prone group. Clearly psychological treatment affects significantly bodily functions associated with CHD. Other risk factors considered were systolic and diastolic blood pressure, blood cholesterol and blood sugar, all of which, together with personality, influenced the degree of sclerosis observed.",1991,"Treatment reduced the degree of sclerosis, particularly in the CHD group; lack of treatment was followed by an increase in sclerosis.",['One-hundred and ninety-two probands were selected on the basis of personality questionnaires as being cancer-prone (100) or CHD-prone (92'],['latter receiving a special kind of behaviour therapy'],"['systolic and diastolic blood pressure, blood cholesterol and blood sugar', 'degree of sclerosis', 'death rates']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0702111', 'cui_str': 'Proband (finding)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",192.0,0.0122693,"Treatment reduced the degree of sclerosis, particularly in the CHD group; lack of treatment was followed by an increase in sclerosis.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Grossarth-Maticek', 'Affiliation': 'Institute of Psychiatry, University of London, De Drespigny Park, Denmark Hill, England.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eysenck', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gallasch', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Vetter', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Frentzel-Beyme', 'Affiliation': ''}]",Behaviour research and therapy,[]
53,7794122,Anticoagulant effects of warfarin and kinetics of K vitamins in blood and feces.,"Patients (40 cases) were treated with daily dosage of warfarin of 2-7 mg after being undergone artificial valve replacements. Twenty one days after administration of warfarin, we examined the patients for kinetics of K vitamins and vitamin K-dependent coagulation factors in blood, and intestinal flora in feces, as well as the relationship between K vitamins and coagulation activity. The following results were obtained. (1) In warfarin-administered patients (Group B), blood levels of vitamin K1 and menaquinone-7, a vitamin K2 homologue, were similar to those in non-warfarin-administered patients. Therefore, administration of warfarin did not significantly decreased the levels. (2) In patients selected randomly from Group B (Group C), the vitamin K1 level in feces was higher than that in non-warfarin-administered patients. The menaquinone-7 level in feces was similar to that in non-warfarin-administered patients. For the total counts of bacteria and the detection rate of vitamin K2-producing bacteria, there was no significant difference between Group C and non-warfarin-administered patients. (3) The above mentioned results of (1) and (2) suggest that it is important for development of anticoagulant effects by warfarin to inhibit conversion from vitamin K1 to reduced vitamin K1, as well as to inhibit the reducing process from vitamin K1-epoxide to vitamin K1. (4) Vitamin K1-epoxide, a metabolite of vitamin K1, appeared in blood after administration of warfarin; there was a lower correlation between the blood level of vitamin K1-epoxide and the warfarin dosage. Further, PIVKA-II appeared in blood after administration of warfarin; there was a inverse lower correlation between the level of PIVKA-II and HPT, and between PIVIKA-II and TT. In conclusion, it has been clarified that vitamin K1-epoxide and PIVKA-II are useful parameters to evaluate anticoagulant effect of warfarin.",1994,"For the total counts of bacteria and the detection rate of vitamin K2-producing bacteria, there was no significant difference between Group C and non-warfarin-administered patients.",['Patients (40 cases'],"['Vitamin K1-epoxide', 'warfarin and kinetics of K vitamins', 'warfarin']","['menaquinone-7 level in feces', 'kinetics of K vitamins and vitamin K-dependent coagulation factors in blood, and intestinal flora in feces', 'blood levels of vitamin K1 and menaquinone-7, a vitamin K2 homologue', 'vitamin K1 level in feces', 'total counts of bacteria and the detection rate of vitamin K2-producing bacteria']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0078379', 'cui_str': 'vitamin K1 epoxide'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]","[{'cui': 'C0078382', 'cui_str': 'menaquinone 7'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1167912', 'cui_str': 'Coagulation factor assay'}, {'cui': 'C0005768'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0031862', 'cui_str': 'phytonadione'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}]",,0.0329752,"For the total counts of bacteria and the detection rate of vitamin K2-producing bacteria, there was no significant difference between Group C and non-warfarin-administered patients.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pharmacy, Kagoshima University Hospital, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Toyohira', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kariyazono', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ishibashi', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saigenji', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shimokawa', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Taira', 'Affiliation': ''}]",Artery,[]
54,32200371,"Response to the Letter to the Editor Regarding ""Effect of Vitamin D Supplementation on Body Composition and Physical Fitness in Healthy Adults: A Double-Blind, Randomized Controlled Trial"".",,2020,,['Healthy Adults'],['Vitamin D Supplementation'],['Body Composition and Physical Fitness'],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.428734,,"[{'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, China.""}, {'ForeName': 'Kumpei', 'Initials': 'K', 'LastName': 'Tanisawa', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Japan.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Japan.'}, {'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Oshima', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Higuchi', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Japan.'}, {'ForeName': 'Zhen-Bo', 'Initials': 'ZB', 'LastName': 'Cao', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China, caozb_edu@yahoo.co.jp.'}]",Annals of nutrition & metabolism,['10.1159/000507106']
55,32543290,Effect of fully immersive virtual reality treatment combined with exercise in fibromyalgia patients: a randomized controlled trial.,"This trial was designed to evaluate the effects of fully immersive virtual reality (IVR) treatment combined with exercise training in fibromyalgia patients. Twenty patients were randomized into exercise group (EG) or IVR combined with exercise group (Exercise+IVR). The EG had combined exercise training consisted of 30 minutes of aerobic training and 30 minutes of Pilates training and Exercise+IVR group had the same protocol with EG plus 20 minutes of IVR, twice a week for 8 weeks. Visual analogue scale for pain, Modified Sensory Organization Test for balance, Tampa Scale of Kinesiophobia for kinesiophobia, Fibromyalgia Impact Questionnaire for impact of fibromyalgia, Fatigue Severity Scale for fatigue, International Physical Activity Questionnaire for level of physical activity, six-minute walk test for functional capacity, and Short-Form 36 Health Survey for quality of life were used for evaluation. Pain, balance, kinesiophobia, impact of fibromyalgia, fatigue, level of physical activity, functional exercise capacity and quality of life scores improved significantly in both groups ( p  < .05). Exercise+IVR group showed significant improvement compared to the EG regarding pain, kinesiophobia, fatigue, level of physical activity, and mental component of quality of life ( p  < .05). IVR treatment may be an effective method as an adjunctive therapy with other exercise trainings in fibromyalgia.",2022,"Exercise+IVR group showed significant improvement compared to the EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05).","['fibromyalgia patients', 'Fibromyalgia Patients', 'Twenty patients']","['Fully Immersive Virtual Reality Treatment Combined with Exercise', 'aerobic training and 30 minutes of Pilates training and Exercise+IVR group had the same protocol with EG plus 20 minutes of IVR', 'fully immersive virtual reality (IVR) treatment combined with exercise training', 'exercise group (EG) or IVR combined with exercise group (Exercise+IVR']","['EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05', 'Visual analogue scale for pain, Modified Sensory Organisation Test for balance, Tampa Scale of Kinesiophobia for kinesiophobia, Fibromyalgia Impact Questionnaire for impact of fibromyalgia, Fatigue Severity Scale for fatigue, International Physical Activity Questionnaire for level of physical activity, six-minute walk test for functional capacity, and Short-Form 36 Health Survey for quality of life', 'Pain, balance, kinesiophobia, impact of fibromyalgia, fatigue, level of physical activity, functional exercise capacity and quality of life scores']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0587617,"Exercise+IVR group showed significant improvement compared to the EG regarding pain, kinesiophobia, fatigue, level of physical activity and mental component of quality of life (p<0.05).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gulsen', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University, Ankara, Turkey.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Soke', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University, Ankara, Turkey.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University, Ankara, Turkey.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University, Ankara, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Gazi University, Ankara, Turkey.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Akcali', 'Affiliation': 'Faculty of Medicine, Department of Algology, Gazi University, Ankara, Turkey.'}]",Assistive technology : the official journal of RESNA,['10.1080/10400435.2020.1772900']
56,7513776,Influence of aprotinin on the thrombomodulin/protein C system in pediatric cardiac operations.,"Thirty consecutive children scheduled for pediatric cardiac operation with cardiopulmonary bypass were included in the study. Before the operation, the patients were randomly divided into two groups: with aprotinin (n = 15, 30,000 U/kg after induction of anesthesia, 30,000 U/kg added to the prime of the cardiopulmonary bypass or without aprotinin (n = 15). Thrombomodulin, (free) protein S, protein C, and thrombin/antithrombin III complex were measured from arterial blood samples taken after induction of anesthesia (at baseline, before aprotinin) and before, during, and after cardiopulmonary bypass until the first postoperative day. Standard coagulation parameters (antithrombin III, fibrinogen, platelet count, and partial thromboplastin time) were without differences between the groups. Thrombomodulin plasma concentrations were within normal range ( < 40 micrograms/L) and were similar in both groups at baseline. During cardiopulmonary bypass and until 5 hours after cardiopulmonary bypass, however, thrombomodulin plasma levels were significantly lower in the children treated with aprotinin. No further differences were observed on the first postoperative day. Protein C and protein S plasma levels did not differ between the two groups. Thrombin/antithrombin III-complex plasma concentrations increased significantly during cardiopulmonary bypass, however, without showing differences between children with (225 +/- 49 micrograms/L) and without (149 +/- 31 micrograms/L) aprotinin treatment. Blood loss and the need for homologous blood and blood products did not differ significantly between the two groups. We concluded that administration of aprotinin resulted in reduced thrombomodulin plasma levels in pediatric patients undergoing cardiac operation without altering protein C/protein S plasma concentration. The exact role of aprotinin in endothelium-derived coagulation should be further studied.",1994,Thrombomodulin plasma concentrations were within normal range ( < 40 micrograms/L) and were similar in both groups at baseline.,"['pediatric cardiac operations', 'children with (225 ', 'Thirty consecutive children scheduled for pediatric cardiac operation with cardiopulmonary bypass were included in the study', 'pediatric patients undergoing cardiac operation without altering protein C/protein S plasma concentration']","['aprotinin', 'L) aprotinin', 'cardiopulmonary bypass or without aprotinin']","['Blood loss and the need for homologous blood and blood products', 'Protein C and protein S plasma levels', 'Thrombomodulin, (free) protein S, protein C, and thrombin/antithrombin III complex', 'Standard coagulation parameters (antithrombin III, fibrinogen, platelet count, and partial thromboplastin time', 'Thrombin/antithrombin III-complex plasma concentrations', 'Thrombomodulin plasma concentrations', 'thrombomodulin plasma levels']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018821', 'cui_str': 'Surgical Procedures, Heart'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0611128', 'cui_str': 'protein C (synaptosomal)'}, {'cui': 'C0072393', 'cui_str': 'Protein S'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0003641', 'cui_str': 'Aprotinin'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0611128', 'cui_str': 'protein C (synaptosomal)'}, {'cui': 'C0072393', 'cui_str': 'Protein S'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0112566,Thrombomodulin plasma concentrations were within normal range ( < 40 micrograms/L) and were similar in both groups at baseline.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Anesthesiology, Justus-Liebig-University Giessen, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zickmann', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schindler', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Welters', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dapper', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hempelmann', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,[]
57,32519208,Assessment of Psychosocial Functioning in a Large Cohort of Patients with Schizophrenia.,"BACKGROUND


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


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


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


The findings on psychosocial functioning of patients with schizophrenia related to severity and skill level could be confirmed. Further findings were the correlation between psychosocial functioning and quality of life, well-being under treatment, and sexuality what emphasizes the substantial importance of a reduced psychosocial functioning.",2021,There was no difference between the two treatment strategies (first-generation versus second-generation antipsychotics) with regard to the PSP.,"['patients with schizophrenia', 'Patients with Schizophrenia', '14 German hospitals between 2010 and 2013 compared two treatment strategies instead of individual drugs', '149 patients were randomised']",[],"['PSP scales as well as measures of quality of life (SF-36) and the Positive and Negative Syndrome Scale (PANSS', ""doctors' assessments regarding psychosocial functioning"", 'Personal and Social Performance (PSP', 'psychosocial functioning and quality of life', 'PSP and quality of life, level of skills (ICF), and severity of disease (PANSS), level of sexual activities and poor well-being under antipsychotic medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C5191071', 'cui_str': '149'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",149.0,0.0268036,There was no difference between the two treatment strategies (first-generation versus second-generation antipsychotics) with regard to the PSP.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kossmann', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Heller', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brüne', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Competence Centre for Clinical Trials - Biometry, University of Bremen, Bremen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heinze', 'Affiliation': 'Brandenburg Medical School, University Clinic for Psychiatry and Psychotherapy, Immanuel Klinik Rüdersdorf, Rüdersdorf, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cordes', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mühlbauer', 'Affiliation': 'Department of Pharmacology, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rüther', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Timm', 'Affiliation': 'Competence Centre for Clinical Trials - Biometry, University of Bremen, Bremen, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gründer', 'Affiliation': 'Department of Molecular Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Juckel', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany. georg.juckel@rub.de.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09773-y']
58,33216113,Safety and Antiviral Effects of Nebulized PC786 in a Respiratory Syncytial Virus Challenge Study.,"BACKGROUND


PC786 is a nebulized nonnucleoside respiratory syncytial virus (RSV) polymerase inhibitor designed to treat RSV, which replicates in the superficial layer of epithelial cells lining the airways.
METHODS


Fifty-six healthy volunteers inoculated with RSV-A (Memphis 37b) were randomly dosed with either nebulized PC786 (5 mg) or placebo, twice daily for 5 days, from either 12 hours after confirmation of RSV infection or 6 days after virus inoculation. Viral load (VL), disease severity, pharmacokinetics, and safety were assessed until discharge. RSV infection was confirmed by reverse-transcription quantitative polymerase chain reaction with any positive value (intention-to-treat infected [ITT-I] population) or RSV RNA ≥1 log10 plaque-forming unit equivalents (PFUe)/mL (specific intention-to-treat infection [ITT-IS] population) in nasal wash samples.
RESULTS


In the ITT-I population, the mean VL area under the curve (AUC) was lower in the PC786 group than the placebo group (274.1 vs 406.6 log10 PFUe/mL × hour; P = .0359). PC786 showed a trend toward reduction of symptom score and mucous weight. In ITT-IS (post hoc analysis), the latter was statistically significant as well as VL AUC (P = .0126). PC786 showed an early time to maximum plasma concentration, limited systemic exposure, and long half-life and consequently a 2-fold accumulation over the 5-day dosing period. PC786 was well tolerated.
CONCLUSIONS


Nebulized PC786 demonstrated a significant antiviral effect against RSV, warranting further clinical study.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.gov: NCT03382431; EudraCT: 2017-002563-18.",2022,"PC786 showed an early Tmax, limited systemic exposure, long half-life and consequently a 2-fold accumulation over the 5-day dosing period.",['56 healthy volunteers inoculated with RSV-A (Memphis 37b'],"['nebulized PC786', 'Nebulized PC786', 'PC786', 'placebo']","['mean VL-AUC', 'early Tmax, limited systemic exposure, long half-life', 'RSV infection', 'tolerated', 'Viral load (VL), disease severity, pharmacokinetics and safety', 'symptom score and mucous weight']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}]","[{'cui': 'C4705549', 'cui_str': 'PC786'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0035235', 'cui_str': 'Respiratory syncytial virus infection'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",56.0,0.222028,"PC786 showed an early Tmax, limited systemic exposure, long half-life and consequently a 2-fold accumulation over the 5-day dosing period.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeVincenzo', 'Affiliation': 'Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Cass', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Woodward', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Meals', 'Affiliation': 'Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Coates', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Daly', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Wheeler', 'Affiliation': 'hVIVO Services Ltd, London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mori', 'Affiliation': 'hVIVO Services Ltd, London, United Kingdom.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Brindley', 'Affiliation': 'KinetAssist Ltd, Quothquan, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Meabh', 'Initials': 'M', 'LastName': 'McCurdy', 'Affiliation': 'Exploristics Ltd, Belfast, United Kingdom.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Murray', 'Affiliation': 'hVIVO Services Ltd, London, United Kingdom.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Strong', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Rapeport', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa716']
59,33075844,The Safety of Low-Dose Aspirin on the Mode of Delivery: Secondary Analysis of the Effect of Aspirin in Gestation and Reproduction Randomized Controlled Trial.,"OBJECTIVE


This study aimed to examine whether prenatal low-dose aspirin (LDA) therapy affects risk of cesarean versus vaginal delivery.
STUDY DESIGN


This study is a secondary analysis of the randomized clinical effects of aspirin in gestation and reproduction (EAGeR) trial. Women received 81-mg daily aspirin or placebo from preconception to 36 weeks of gestation. Mode of delivery and obstetric complications were abstracted from records. Log-binomial regression models estimated relative risk (RR) of cesarean versus vaginal delivery. Data were analyzed among the total preconception cohort, as well as restricted to women who had a live birth.
RESULTS


Among 1,228 women, 597 had a live birth. In the intent-to-treat analysis, preconception-initiated LDA was not associated with risk of cesarean (RR = 1.02; 95% confidence interval [CI]: 0.98-1.07) compared with placebo. Findings were similar in just women with a live birth and when accounting prior cesarean delivery and parity.
CONCLUSION


Preconception-initiated daily LDA was not associated with mode of delivery among women with one to two prior losses.
KEY POINTS


· Aspirin was not associated with risk of cesarean section.. · Aspirin was not associated with mode of delivery.. · No increased risk of bleeding with use of aspirin..",2022,Aspirin was not associated with risk of cesarean section.. ·,"['1,228 women, 597 had a live birth', 'women who had a live birth']","['prenatal low-dose aspirin (LDA) therapy', 'Preconception-initiated daily LDA', 'aspirin or placebo', 'Low-Dose Aspirin', 'Aspirin', 'placebo', 'aspirin']","['risk of bleeding', 'risk of cesarean']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",1228.0,0.331762,Aspirin was not associated with risk of cesarean section.. ·,"[{'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Eubanks', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Micah J', 'Initials': 'MJ', 'LastName': 'Hill', 'Affiliation': 'Reproductive and Adult Endocrinology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Decherney', 'Affiliation': 'Reproductive and Adult Endocrinology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Ye', 'Affiliation': 'Glotech, Inc., Rockville, Maryland.'}, {'ForeName': 'Jeannie G', 'Initials': 'JG', 'LastName': 'Radoc', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}]",American journal of perinatology,['10.1055/s-0040-1718581']
60,33108905,No difference in gait pattern between a short collum femoris-preserving and a conventional stem: 44 randomised total hip arthroplasty patients stem evaluated after 2 years.,"BACKGROUND


The uncemented collum femoris-preserving (CFP) stem offers preservation of the femoral neck and a more conservative soft tissue resection, which may facilitate a more normal walking pattern. We used gait analysis to evaluate if patients operated with a CFP stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a conventional uncemented stem.
METHODS


44 patients randomised to receive either a CFP or a Corail stem were studied and were operated using a direct lateral incision. Gait analysis was performed 2 years after the operation with a 12-camera motion capture system and 2 force plates. Hip kinematics and kinetics were analysed and 66 subjects served as controls.
RESULTS


None of the variables: speed, stride, cadence and stance showed any statistical significant difference between the 2 study groups. Neither did the hip kinematics and kinetics. Compared to controls, patients operated with the CFP stem showed an increased stance (62.5% vs. 61.1%,  p <  0.006) and decreased hip abduction (-2.1° vs. -6.5°). Patients operated with the Corail stem showed decreased speed (1.18 vs. 1.23 m/second), and stride length (1.26 vs. 1.33 m), decreased hip extension (-7.5° vs. -12.8°) and range of hip flexion/extension (38° vs. 40.9°), as well as their hip adduction that was increased (6.3° vs. 4°), whereas their hip abduction was reduced (-2.8° vs. -6.5°), ( p <  0.004) compared to the controls.
CONCLUSIONS


Use of a CFP stem did not significantly influence any of the gait parameters studied when compared to a standard stem, but still both stems studied were associated with gait deviations when compared to controls. Whether these differences could be attributed to the stem used, the underlying hip disease, or both is still unknown.",2022,"None of the variables: speed, stride, cadence and stance showed any statistical significant difference between the 2 study groups.","['66 subjects served as controls', '44 patients randomised to receive either a']","['conventional uncemented stem', 'uncemented collum femoris-preserving (CFP) stem', 'CFP or a Corail stem']","['gait pattern', 'stride, cadence and stance', 'Hip kinematics and kinetics', 'stance', 'hip abduction', 'favourable hip kinematics and kinetics', 'hip extension', 'stride length', 'hip kinematics and kinetics', 'gait deviations', 'range of hip flexion/extension']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1096245', 'cui_str': 'Gait deviation'}, {'cui': 'C0576003', 'cui_str': 'Range of hip flexion'}]",,0.0293026,"None of the variables: speed, stride, cadence and stance showed any statistical significant difference between the 2 study groups.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zügner', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Tranberg', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Kärrholm', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Puretic', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Maziar', 'Initials': 'M', 'LastName': 'Mohaddes', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700020967645']
61,32684094,Piloting a Dementia Caregiver Intervention in a Primary Care Setting.,"OBJECTIVES


The purpose of this pilot study is to examine the efficacy of a theoretically based, 6-week dementia caregiver support group in a primary care setting.
METHODS


Using a quasi-experimental design, 22 participants completed the caregiver support group. Participants were mostly in their mid-60 s ( M  = 63 years old), female ( n  = 19), Caucasian ( n  = 14), and identified as either the care recipient's child or spouse ( n  = 19). At baseline and 6 weeks, participants completed self-report measures related to demographic information, caregiver preparedness, strain, and depressive symptoms, and care recipient's neuropsychiatric symptoms. Participants also completed a satisfaction survey. Within-subjects  t -tests were run to determine if participants' scores changed over time.
RESULTS


Results revealed that participants demonstrated a significant increase in mean caregiver preparedness scores. No significant effects were found for caregiver strain, depressive symptoms, and distress related to neuropsychiatric symptoms. Participants rated being largely satisfied with the program.
CONCLUSIONS


Results suggest that this 6-week caregiver support group may be a promising caregiver intervention in primary care clinics.
CLINICAL IMPLICATIONS


Findings support the importance of caregiver support for persons with dementia in primary care.",2022,"No significant effects were found for caregiver strain, depressive symptoms, and distress related to neuropsychiatric symptoms.","[""63\xa0years old), female ( n \xa0=\xa019), Caucasian ( n \xa0=\xa014), and identified as either the care recipient's child or spouse ( n \xa0=\xa019"", 'persons with dementia in primary care', '22 participants completed the caregiver support group']",[],"['caregiver strain, depressive symptoms, and distress related to neuropsychiatric symptoms', ""demographic information, caregiver preparedness, strain, and depressive symptoms, and care recipient's neuropsychiatric symptoms"", 'mean caregiver preparedness scores']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.039451,"No significant effects were found for caregiver strain, depressive symptoms, and distress related to neuropsychiatric symptoms.","[{'ForeName': 'Mona Shah', 'Initials': 'MS', 'LastName': 'Barman', 'Affiliation': 'Department of Psychology, University of Central Florida, Orlando, Florida, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Paulson', 'Affiliation': 'Department of Psychology, University of Central Florida, Orlando, Florida, USA.'}]",Clinical gerontologist,['10.1080/07317115.2020.1791294']
62,33219500,"The Impact of Therapeutic Exercises on the Quality of Life and Shoulder Range of Motion in Women After a Mastectomy, an RCT.","Breast cancer ranks highest in incidence and mortality among females and second among both genders. Lebanon has the second highest rate of breast cancer worldwide for those 35-39 years old and the highest for those 40-49. Mastectomy often results in deceased shoulder and arm mobility and decreased quality of life. The objective of this study was to assess the effect of an educational program of therapeutic exercises on the quality of life and functional ability in women after a mastectomy. Sixty women undergoing a mastectomy were randomly assigned to either an intervention or control group. The intervention group received extensive pre-surgery education as well as training on therapeutic exercises. Follow-up phone calls to the intervention group were made to ensure that the exercises were being done. Both groups were visited at home at two and four weeks to obtain the outcome variables. The Breast Cancer Patient Version was used to assess quality of life, and the ""Goniometer"" was used to assess the range of motion of the affected shoulder. At two and four weeks after surgery, women in the intervention group had significant improvements in their shoulder range of motion: flexion, extension, and abduction were significantly different between the control and intervention group at p = 0.04-0.00. For quality of life, physical, psychological, psychological, social, and spiritual well-being were significantly higher for the intervention group at both two and four weeks after surgery, p < 0.001. In a middle-income country, one-to-one education provided by a nurse, which included demonstrations, back demonstrations, and weekly phone calls had a positive impact on women's shoulder range of motion and quality of life. NCT04184102.",2022,"For quality of life, physical, psychological, psychological, social, and spiritual well-being were significantly higher for the intervention group at both two and four weeks after surgery, p < 0.001.","['Sixty women undergoing a mastectomy', 'women after a mastectomy', 'Women After a Mastectomy, an RCT']","['Lebanon', 'Therapeutic Exercises', 'extensive pre-surgery education as well as training on therapeutic exercises', 'educational program of therapeutic exercises']","['Quality of Life and Shoulder Range of Motion', 'shoulder range of motion: flexion, extension, and abduction', 'quality of life', 'quality of life, physical, psychological, psychological, social, and spiritual well-being', 'quality of life and functional ability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}]","[{'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",60.0,0.0309159,"For quality of life, physical, psychological, psychological, social, and spiritual well-being were significantly higher for the intervention group at both two and four weeks after surgery, p < 0.001.","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Majed', 'Affiliation': 'Medical Surgical Unit, American University of Beirut Medical Center (AUBMC), Beirut, Lebanon.'}, {'ForeName': 'Charlene A', 'Initials': 'CA', 'LastName': 'Neimi', 'Affiliation': 'California State University Channel Islands, Camarillo, CA, USA.'}, {'ForeName': 'Sawsan Moustafa', 'Initials': 'SM', 'LastName': 'Youssef', 'Affiliation': 'Medical-Surgical Nursing Faculty of Health Sciences, Beirut Arab University, Beirut, Lebanon.'}, {'ForeName': 'Khaled Ahmed', 'Initials': 'KA', 'LastName': 'Takey', 'Affiliation': 'Beirut Arab University, Beirut, Lebanon.'}, {'ForeName': 'Lina Kurdahi', 'Initials': 'LK', 'LastName': 'Badr', 'Affiliation': 'School of Nursing, Azusa Pacific University, Azusa, CA, 91702, USA. lbadr@apu.edu.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01894-z']
63,32673446,Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors.,"The impact of repeated daily 500-mg fedratinib (an oral selective Janus kinase [JAK] 2 inhibitor) on QTc and other electrocardiogram (ECG) parameters was assessed in 60 patients with advanced solid tumors. Patients received placebo on day 1 and fedratinib 500 mg daily for 14 days. Concentration-QTc analysis was performed with change-from-baseline QTc corrected by Fridericia's formula (ΔQTcF) as the dependent variable. Fedratinib median time to maximum plasma concentration (C max  ) was observed 3 hours postdose on day 15. The largest difference between means for fedratinib and placebo was 0.5 bpm (90%CI, -2.75 to 3.72 bpm) for heart rate (3 hours postdose) and 4.3 milliseconds (90%CI, 1.04-7.60 milliseconds) for QTcF (4 hours postdose). The estimated slope of the fedratinib concentration-QTcF relationship was shallow and not statistically significant: -0.0005 milliseconds per ng/mL (90%CI, -0.00145 to 0.00050 milliseconds per ng/mL). Predicted fedratinib placebo-corrected ΔQTcF was 0.6 milliseconds (90%CI, -1.80 to 2.93 milliseconds) at the geometric mean of the observed C max  (3615 ng/mL). Fedratinib did not affect PR or QRS intervals. No patients had QTcF > 60 milliseconds, and no patients experienced QTcF ≥ 500 milliseconds. Fedratinib did not cause clinically relevant ECG effects or QTc prolongation. Safety findings were consistent with the known safety profile.",2021,Fedratinib did not cause clinically relevant ECG effects or QTc prolongation.,"['Patients With Advanced Solid Tumors', '60 patients with advanced solid tumors']","['placebo-corrected ΔQTcF', 'placebo']","['Fedratinib median time to maximum plasma concentration (C max  ', 'heart rate', 'QTc and other electrocardiogram (ECG) parameters', 'fedratinib concentration-QTcF relationship', 'PR or QRS intervals']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]","[{'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}]",60.0,0.275115,Fedratinib did not cause clinically relevant ECG effects or QTc prolongation.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'ERT, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Carayannopoulos', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'ERT, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Bristol Myers Squibb, Summit, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.850']
64,32594783,"Effect of seat height on manual wheelchair foot propulsion, a repeated-measures crossover study: part 2 - wheeling backward on a soft surface.","PURPOSE


The aim of this study was to test the hypotheses that, during manual-wheelchair foot propulsion backward on a soft surface, lowering the seat height increases speed, push frequency and push effectiveness, and decreases perceived difficulty.
MATERIALS AND METHODS


In a repeated-measures crossover study, 50 able-bodied participants used one foot to propel a manual wheelchair 5 m backward on a soft surface at 5 seat heights, ranging from 5.08 cm below to about 5.08 cm above lower-leg length, in random order. We recorded Wheelchair Skills Test (WST) capacity scores and used the Wheelchair Propulsion Test (WPT) to calculate speed (m/s), push frequency (cycles/s) and push effectiveness (m/cycle). We also recorded the participants' perceived difficulty (0-4) and video-recorded each trial.
RESULTS


WST capacity scores were reduced at the higher seat heights. Using repeated-measures models (adjusted for age, sex and order), there were negative relationships between seat height and speed ( p  < 0.0001) and push effectiveness ( p  < 0.0001). Lowering the seat height by 5.08 cm below lower-leg length corresponded to improvements in speed of 0.097 m/s and in push effectiveness of 0.101 m/cycle. The trend for push frequency was also significant ( p  = 0.035) but the effect size was smaller. Perceived difficulty increased with seat height ( p  < 0.0001). The video-recordings provided qualitative kinematic data regarding the seated ""gait cycles"".
CONCLUSIONS


During manual-wheelchair foot propulsion backward on a soft surface, lowering the seat height increases speed and push effectiveness, and decreases perceived difficulty.IMPLICATIONS FOR REHABILITATIONBackward wheelchair foot propulsion on soft surfaces is affected by seat height.Speed (m/s) is improved if the seat height is lowered.Push effectiveness (m/gait cycle) is improved if the seat height is lowered.Perceived difficulty of propulsion is lower if the seat height is lowered.",2022,Perceived difficulty increased with seat height ( p  < 0.0001).,[],['seat height'],"['WST capacity scores', 'seat height increases speed, push frequency and push effectiveness', 'Wheelchair Skills Test (WST) capacity scores and used the Wheelchair Propulsion Test (WPT) to calculate speed (m/s), push frequency (cycles/s) and push effectiveness (m/cycle', 'seat height', 'push frequency']",[],"[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0557899', 'cui_str': 'Height increased'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0439482', 'cui_str': 'Hz'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",50.0,0.0266554,Perceived difficulty increased with seat height ( p  < 0.0001).,"[{'ForeName': 'Nathaniel David', 'Initials': 'ND', 'LastName': 'Heinrichs', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Medicine, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Ronald Lee', 'Initials': 'RL', 'LastName': 'Kirby', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Medicine, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Cher', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Department of Occupational Therapy, Nova Scotia Health Authority, Halifax, Canada.'}, {'ForeName': 'Kristin Frances Joyce', 'Initials': 'KFJ', 'LastName': 'Russell', 'Affiliation': 'Department of Occupational Therapy, Nova Scotia Health Authority, Halifax, Canada.'}, {'ForeName': 'Christopher John', 'Initials': 'CJ', 'LastName': 'Theriault', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}, {'ForeName': 'Steve Paul', 'Initials': 'SP', 'LastName': 'Doucette', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2020.1782490']
65,32771433,Use of nasal mucosa graft in tympanoplasty.,"INTRODUCTION


Tympanoplasty techniques with different types of graft have been used to close tympanic perforations since the 19th century. Tragal cartilage and temporalis fascia are the most frequently used types of graft. They lead to similar functional and morphological results in most cases. Although little published evidence is present, nasal mucosa has also been shown to be a good alternative graft.
OBJECTIVE


Surgical and audiological outcomes at the six-month follow-up in type I tympanoplasty using nasal mucosa and temporalis fascia grafts were analyzed.
METHODS


A total of 40 candidates for type I tympanoplasty were randomly selected and divided into the nasal mucosa and temporalis fascia graft groups with 20 in each group. The assessed parameters included surgical success; the rate of complete closure of tympanic perforation and hearing results; the difference between post- and pre-operative mean quadritonal airway-bone gap, six months after surgery.
RESULTS


Complete closure of the tympanic perforation was achieved in 17 of 20 patients in both groups. The mean quadritonal airway-bone gap closures were11.9 and 11.1 dB for the nasal mucosa and temporalis fascia groups, respectively. There was no statistically significant difference between the groups.
CONCLUSION


The nasal mucosa graft can be considered similar to the temporal fascia when considering the surgical success rate of graft acceptance and ultimate audiological gain.",2022,"There was no statistically significant difference between the groups.
",['A total of 40 candidates for type I tympanoplasty'],[],"['tympanic perforation', 'surgical success; the rate of complete closure of tympanic perforation and hearing results; the difference between post- and pre-operative mean quadritonal airway-bone gap, six months after surgery', 'mean quadritonal airway-bone gap closures']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]",[],"[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",40.0,0.0387851,"There was no statistically significant difference between the groups.
","[{'ForeName': 'Sandro Barros', 'Initials': 'SB', 'LastName': 'Coelho', 'Affiliation': 'Universidade Federal do Ceará, Hospital Universitário Walter Cantídeo, Fortaleza, CE, Brazil. Electronic address: sandrocoelhomd@gmail.com.'}, {'ForeName': 'Willian da Silva', 'Initials': 'WDS', 'LastName': 'Lopes', 'Affiliation': 'Universidade Federal do Maranhão, Otoclínica, Imperatriz, MA, Brazil.'}, {'ForeName': 'Gabriela de Andrade Meireles', 'Initials': 'GAM', 'LastName': 'Bezerra', 'Affiliation': 'Universidade Federal do Ceará, Hospital Universitário Walter Cantídeo, Fortaleza, CE, Brazil.'}, {'ForeName': 'Davi Farias de', 'Initials': 'DF', 'LastName': 'Araújo', 'Affiliation': 'Universidade Federal do Ceará, Hospital Universitário Walter Cantídeo, Fortaleza, CE, Brazil.'}, {'ForeName': 'Adriano Sérgio Freire', 'Initials': 'ASF', 'LastName': 'Meira', 'Affiliation': 'SOS Otorrino Clínica de Otorrinolaringologia, João Pessoa, PB, Brazil.'}, {'ForeName': 'Sílvio da Silva', 'Initials': 'SDS', 'LastName': 'Caldas Neto', 'Affiliation': 'Universidade Federal de Pernambuco, Recife, PE, Brazil.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2020.06.006']
66,32720131,Focused Training of Community Health Volunteers on Cervical Cancer in Rural Kisumu.,"The cancer disease burden is higher in the low- and middle-income countries like Kenya where uptake of screening services is low. Community health volunteers (CHVs) have been shown to be effective in improving uptake of health services and could also be used in cervical cancer screening. However, they still have inadequate knowledge hindering effective public education. The aim of this study is to determine the effect of focused training of the CHVs on their knowledge on cervical cancer and screening uptake among women of reproductive age. This was a quasi-experimental study in rural sub-counties of Nyando and Nyakach. Nyando was the intervention arm with 186 CHVs and Nyakach the control with 239 CHVs. Participants' knowledge on cervical cancer was assessed using a self-administered questionnaire. CHVs in the intervention arm were trained about cervical cancer and screening. Knowledge was re-assessed following a 6-month public education period. The focused training improved the CHVs' knowledge on cervical cancer to 60.9% compared to 13.4% in the control arm (p = 0.004) at the end-line. The knowledge was dependent on the level of education (χ 2  = 34.41, p = 0.045), religion (χ 2  = 25.85, p = 0.007), and occupation (χ 2  = 95.04, p < 0.0001). Screening uptake was significantly associated with knowledge of risk factors (p = 0.019) and sign and symptoms (p = 0.017). Screening uptake improved in the intervention arm while declined in the control arm. The training significantly improved the CHVs' knowledge on cervical cancer and uptake of screening services in the intervention area, Kisumu County, Kenya, and should be continuous.",2022,"The training significantly improved the CHVs' knowledge on cervical cancer and uptake of screening services in the intervention area, Kisumu County, Kenya, and should be continuous.","['Community Health Volunteers on Cervical Cancer in Rural Kisumu', 'rural sub-counties of Nyando and Nyakach', 'women of reproductive age', 'Community health volunteers (CHVs']",['CHVs'],"[""CHVs' knowledge on cervical cancer"", 'cervical cancer', 'Screening uptake', 'knowledge of risk factors', ""CHVs' knowledge on cervical cancer and uptake of screening services""]","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0225371,"The training significantly improved the CHVs' knowledge on cervical cancer and uptake of screening services in the intervention area, Kisumu County, Kenya, and should be continuous.","[{'ForeName': 'Edwin Onyango', 'Initials': 'EO', 'LastName': 'Ochomo', 'Affiliation': 'AMPATH Cervical Cancer Program, P.O. Box 4606, Eldoret, Kenya. edochomo@gmail.com.'}, {'ForeName': 'Samson', 'Initials': 'S', 'LastName': 'Ndege', 'Affiliation': 'AMPATH Cervical Cancer Program, P.O. Box 4606, Eldoret, Kenya.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Itsura', 'Affiliation': 'AMPATH Cervical Cancer Program, P.O. Box 4606, Eldoret, Kenya.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01839-6']
67,32760602,"Effect of Two Different Doses of Dexmedetomidine as Adjuvant in Bupivacaine Induced Subarachnoid Block for Elective Abdominal Hysterectomy Operations: A Prospective, Double-blind, Randomized Controlled Study.",[This retracts the article DOI: 10.5001/omj.2015.52.].,2020,[This retracts the article DOI: 10.5001/omj.2015.52.].,['Elective Abdominal Hysterectomy Operations'],"['Dexmedetomidine', 'Bupivacaine']",[],"[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.32909,[This retracts the article DOI: 10.5001/omj.2015.52.].,[],Oman medical journal,['10.5001/omj.2020.76']
68,32730174,Inspiratory muscle strength training lowers blood pressure and sympathetic activity in older adults with OSA: a randomized controlled pilot trial.,"Previous work has shown lowered casual blood pressure after just 6 wk of inspiratory muscle strength training (IMST), suggesting IMST as a potential therapeutic in the prevention/treatment of hypertension. In this study, we assessed the effects of IMST on cardiovascular parameters in older, overweight adults diagnosed with moderate and severe obstructive sleep apnea (OSA). Subjects were randomly assigned to one of two interventions  1 ) high-intensity IMST ( n  = 15, 75% maximal inspiratory pressure), or  2 ) a control intervention ( n  = 10, 15% maximum inspiratory pressure). Subjects in both groups trained at home completing 30 training breaths/day, 5 days/wk for 6 wk. Pre- and posttraining measures included maximal inspiratory pressure, casual and ambulatory blood pressures, spontaneous cardiac baroreflex sensitivity, and muscle sympathetic nerve activity. Men and women in the high-intensity IMST group exhibited reductions in casual systolic (SBP), diastolic (DBP), and mean arterial blood pressures (MAP) [SBP: -8.82 ± 4.98 mmHg; DBP: -4.69 ± 2.81 mmHg; and MAP: -6.06 ± 1.03 mmHg;  P  < 0.002] and nighttime SBP (pre: -12.00 ± 8.20 mmHg;  P  < 0.01). Muscle sympathetic nerve activities also were lower (-6.97 ± 2.29 bursts/min -1 ;  P  = 0.01 and -9.55 ± 2.42 bursts/100 heartbeats;  P  = 0.002) by  week 6 . Conversely, subjects allocated to the control group showed no change in casual blood pressure or muscle sympathetic nerve activity and a trend toward higher overnight blood pressures. A short course of high-intensity IMST may offer significant respiratory and cardiovascular benefits for older, overweight adults with OSA. For Clinical Trial Registration, see https://www.clinicaltrials.gov (Identifier: NCT02709941). NEW & NOTEWORTHY  Older, obese adults with moderate-severe obstructive sleep apnea who perform 5 min/day high-intensity inspiratory muscle strength training (IMST) exhibit lowered casual and nighttime systolic blood pressure and sympathetic nervous outflow. In contrast, adults assigned to a control (low-intensity) intervention exhibit no change in casual blood pressure or muscle sympathetic nerve activity and a trend toward increased overnight blood pressure. Remarkably, adherence to IMST even among sleep-deprived and exercise-intolerant adults is high (96%).",2020,Muscle sympathetic nerve activities also were lower (-6.97 ± 2.29 bursts/min -1 ; p=0.01 and -9.55 ± 2.42 bursts per 100 heartbeats; p=0.002) by Week 6.,"['older adults with OSA', 'older, overweight adults with OSA', 'older, overweight adults diagnosed with moderate and severe obstructive sleep apnea (OSA']","['intensity IMST (n=15, 75% maximal inspiratory pressure) or ii) a control intervention', 'Pre- and post', 'Inspiratory muscle strength training', 'IMST', 'high intensity IMST', 'inspiratory muscle strength training (IMST), suggesting IMST']","['maximal inspiratory pressure, casual and ambulatory blood pressures, spontaneous cardiac baroreflex sensitivity, and muscle sympathetic nerve activity', 'casual systolic, diastolic and mean arterial blood pressures', 'cardiovascular parameters', 'casual blood pressure', 'casual blood pressure or muscle sympathetic nerve activity', 'overnight blood pressures', 'Muscle sympathetic nerve activities', 'blood pressure and sympathetic activity', 'nighttime SBP']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",,0.0309803,Muscle sympathetic nerve activities also were lower (-6.97 ± 2.29 bursts/min -1 ; p=0.01 and -9.55 ± 2.42 bursts per 100 heartbeats; p=0.002) by Week 6.,"[{'ForeName': 'Guadalupe Elizabeth', 'Initials': 'GE', 'LastName': 'Ramos-Barrera', 'Affiliation': 'Department of Physiology, University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'DeLucia', 'Affiliation': 'Department of Physiology, University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'E Fiona', 'Initials': 'EF', 'LastName': 'Bailey', 'Affiliation': 'Department of Physiology, University of Arizona College of Medicine, Tucson, Arizona.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00024.2020']
69,32875946,Comparing efficacy and safety of potassium hydroxide 5% solution with 5-fluorouracil cream in patients with actinic keratoses: a randomized controlled trial.,"BACKGROUND


Actinic keratosis (AK) is a pre-cancerous skin lesion, associated with development of squamous cell carcinoma. Current treatment options are limited.
OBJECTIVES


To compare the efficacy and safety of topical 5-fluorouracil cream (5-FU) and potassium hydroxide 5% (KOH) in the treatment of AK.
METHODS


Eighteen patients with AK applied KOH solution or 5-FU on each side of their scalp/face, randomly. The efficacy and safety of these treatments were compared.
RESULTS


Thirteen (118 lesions) and ten (83 lesions) patients were successfully followed for one and three months, respectively. After one month, KOH showed a better clinical response (81% vs. 58%;  p -value = 0.007) and dermoscopic response (KOH, 65% vs. 5-FU, 46%;  p -value = 0.04); while no differences were noted after three months (clinical response, 83% vs.70%,  p -value = 0.1; dermoscopic response, 76% vs. 59%,  p -value = 0.1). No significant differences in the recurrence rate of the lesion between the two groups were noted at the end of the third month ( p -value = 0.5). Regarding the safety of the treatments, the risk of developing erythema, scaling, sand swelling was higher in 5-FU group ( p -value < 0.0001, for all), while more patients in KOH group had erosion and ulcer ( p -value < 0.001 for both). KOH was up to 96% less expensive than 5-FU.
LIMITATIONS


Low number of patients and short-term follow-up limited the analysis.
CONCLUSION


KOH solution offers a faster and less expensive resolution of AK lesions than does 5-FU.
CLINICAL TRIAL CODE (IRCT.IR)


IRCT20180909040978N1.",2022,No significant differences in the recurrence rate of the lesion between the two groups were noted at the end of the third month (P-value =0.5).,"['Eighteen patients with AK applied', 'patients with actinic keratoses', 'Thirteen (118 lesions) and ten (83 lesions) patients']","[' : Actinic keratosis (AK', 'KOH', '5-FU', 'KOH solution or 5-FU', 'potassium hydroxide 5% solution with 5-fluorouracil cream', 'topical 5-fluorouracil cream (5-FU) and potassium hydroxide 5% (KOH']","['recurrence rate of the lesion', 'efficacy and safety', 'clinical response', 'KOH', 'dermoscopic response', 'expensive resolution of AK lesions', 'risk of developing erythema, scaling, sand swelling', 'erosion and ulcer']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C3215191', 'cui_str': 'Fluorouracil-containing product in cutaneous dose form'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C4759711', 'cui_str': 'Sand'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",18.0,0.0573959,No significant differences in the recurrence rate of the lesion between the two groups were noted at the end of the third month (P-value =0.5).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Salehi Farid', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Niknam', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Kheirollah', 'Initials': 'K', 'LastName': 'Gholami', 'Affiliation': 'Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Tavakolpour', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Teimourpour', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Daneshpazhooh', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Nili', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arghavan', 'Initials': 'A', 'LastName': 'Azizpour', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nasimi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Mahmoudi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1817839']
70,32795619,Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins.,"OBJECTIVE


Mechanochemical ablation (MOCA) is a nonthermal nontumescent method of treating saphenous vein insufficiency. The feasibility and short-term results of MOCA are good, but its long-term results are unknown. A randomized study was performed to compare MOCA with endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in the setting of unilateral great saphenous vein (GSV) insufficiency.
METHODS


Venous outpatient clinic patients with varicose veins (CEAP class C2-C4) caused by GSV insufficiency were invited to participate in the study; in total, 132 patients met the inclusion criteria and were willing to participate. Patients were randomized to treatment (2:1:1 for MOCA, EVLA, and RFA, respectively). The state of the GSV with duplex Doppler ultrasound examination and the disease-specific quality of life were assessed at 1 month, 1 year, and 3 years after the treatment.
RESULTS


Some patients declined to continue in the study after randomization; in total, 117 patients underwent treatment. At 3 years, the occlusion rate was significantly lower with MOCA than with either EVLA or RFA (82% vs 100%; P = .005). Quality of life was similar between the groups. In the MOCA group, GSVs that were larger than 7 mm in diameter preoperatively were more likely to recanalize during the follow-up period. The partial recanalizations of proximal GSV observed at 1 year progressed during the follow-up.
CONCLUSIONS


MOCA is a feasible treatment option in an outpatient setting, but its technical success rates are inferior compared with endovenous thermal ablation. Its use in large-caliber veins should be considered carefully.",2021,Quality of life was similar between the groups.,"['117 patients underwent treatment', 'Venous outpatient clinic patients with varicose veins (CEAP class C2-4) caused by GSV insufficiency were invited to participate in the study; in total, 132 patients filled the inclusion criteria and were willing to participate', 'insufficient great saphenous veins']","['MOCA', 'Mechanochemical ablation (MOCA', 'EVLA', 'MOCA with endovenous laser ablation (EVLA) and radiofrequency ablation (RFA', 'mechanochemical and thermal ablation']","['disease-specific quality of life', 'Quality of life', 'partial recanalizations of proximal GSV', 'occlusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",132.0,0.0265649,Quality of life was similar between the groups.,"[{'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Vähäaho', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland. Electronic address: sari.vahaaho@fimnet.fi.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Halmesmäki', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Albäck', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Noronen', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Venermo', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.08.007']
71,32837847,"A Randomized, Open-Label, Controlled Clinical Trial of Azvudine Tablets in the Treatment of Mild and Common COVID-19, a Pilot Study.","Coronavirus disease 2019 (COVID-19) has spread worldwide. To date, no specific drug for COVID-19 has been developed. Thus, this randomized, open-label, controlled clinical trial (ChiCTR2000029853) was performed in China. A total of 20 mild and common COVID-19 patients were enrolled and randomly assigned to receive azvudine and symptomatic treatment (FNC group), or standard antiviral and symptomatic treatment (control group). The mean times of the first nucleic acid negative conversion (NANC) of ten patients in the FNC group and ten patients in the control group are 2.60 (SD 0.97; range 1-4) d and 5.60 (SD 3.06; range 2-13) d, respectively ( p  = 0.008). The mean times of the first NANC of four newly diagnosed subjects in the FNC group and ten subjects in the control group are 2.50 (SD 1.00; range 2-4) d and 9.80 (SD 4.73; range 3-19) d, respectively (starting from the initial treatment) ( p  = 0.01). No adverse events occur in the FNC group, while three adverse events occur in the control group ( p  = 0.06). The preliminary results show that FNC treatment in the mild and common COVID-19 may shorten the NANC time versus standard antiviral treatment. Therefore, clinical trials of FNC treating COVID-19 with larger sample size are warranted.",2020,"No adverse events occurred in the FNC group, while 3 adverse events occurred in the control group (p = 0.06).",['A total of 20 mild and common COVID-19 patients'],"['Azvudine Tablets', 'azvudine and symptomatic treatment (FNC group), or standard antiviral and symptomatic treatments (control group', 'FNC']","['NANC time', 'mean times of the first nucleic acid negative conversion (NANC', 'adverse events', 'mean times of the first NANC']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4045536', 'cui_str': 'azvudine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.0744737,"No adverse events occurred in the FNC group, while 3 adverse events occurred in the control group (p = 0.06).","[{'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Zujiang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Jingchao', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Thoracic Surgery Henan Provincial Chest Hospital Zhengzhou 450008 China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Henan Key Laboratory of Organic Functional Molecule and Drug Innovation School of Chemistry and Chemical Engineering Henan Normal University Xinxiang 453007 China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Laboratory Henan Provincial Chest Hospital Zhengzhou 450008 China.'}, {'ForeName': 'Haiyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Guangying', 'Initials': 'G', 'LastName': 'Cui', 'Affiliation': 'Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Henan Genuine Biotech Co., Ltd. 10 Fuxing Road, Xincheng District Pingdingshan Henan 467036 China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics Huangchuan County People's Hospital Huangchuan County Xinyang 465150 China.""}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Medical Department Xixian people's Hospital Xixian Xinyang 464300 China.""}, {'ForeName': 'Zhaohai', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Shengkun', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Guangzhong', 'Initials': 'G', 'LastName': 'Pei', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery Henan Provincial Chest Hospital Zhengzhou 450008 China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Wenquan', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Henan new drug creation and drug safety evaluation Collaborative Innovation Center Zhengzhou University Zhengzhou 450001 China.'}, {'ForeName': 'Chuanjun', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Henan new drug creation and drug safety evaluation Collaborative Innovation Center Zhengzhou University Zhengzhou 450001 China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Henan new drug creation and drug safety evaluation Collaborative Innovation Center Zhengzhou University Zhengzhou 450001 China.'}, {'ForeName': 'Chuansong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Guangshan County People's Hospital Guangshan County Xinyang 465450 China.""}, {'ForeName': 'Jinfa', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Henan Genuine Biotech Co., Ltd. 10 Fuxing Road, Xincheng District Pingdingshan Henan 467036 China.'}, {'ForeName': 'Junbiao', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Henan Key Laboratory of Organic Functional Molecule and Drug Innovation School of Chemistry and Chemical Engineering Henan Normal University Xinxiang 453007 China.'}]","Advanced science (Weinheim, Baden-Wurttemberg, Germany)",['10.1002/advs.202001435']
72,32789748,The Effect of Prechemotherapy Education Using Audio Visual Methods on the Distress of Patients with Cancer.,"Chemotherapy is a commonly used cancer treatment. However, it causes physical side effects and psychological side effects such as distress. Providing prechemotherapy education using audiovisual methods can reduce distress, but not all research about the use of educational videos have the same conclusions. This study aimed to evaluate the effect of prechemotherapy education using audio visual methods on distress of patients with cancer. This study was a quasi-experiment using pre-test and posttest design with a control group. Eighty-two cancer patients who undergo chemotherapy for the first time were divided into 2 groups with forty-one patients in the control group and forty-one patients in the intervention group. Patients in the control group received education with a booklet (usual care), while the intervention group received prechemotherapy education using audio visual materials. Patients completed a distress thermometer before and 1-2 weeks after chemotherapy. The analysis used the Wilcoxon test in each group before and 1-2 weeks after prechemotherapy education. The Mann-Whitney tests were used to determine the difference in distress scores between the two groups. Statistical significance was defined as p value < 0.05. The effect of prechemotherapy education in each group was in the control group (p = 0.004) and the intervention group (p = 0.000). The control group had a mean decrease of 1.69 points, and the intervention group had a mean decrease of 1.29 points. There was a significant difference of distress between control group and intervention group with a p value of 0.037. The conclusion is the prechemotherapy education using audio visual method can reduce distress in patients with cancer in addition to the usual method.",2022,The effect of prechemotherapy education in each group was in the control group (p = 0.004) and the intervention group (p = 0.000).,"['Patients with Cancer', 'Eighty-two cancer patients who undergo chemotherapy for the first time', 'patients with cancer']","['Prechemotherapy Education Using Audio Visual Methods', 'prechemotherapy education using audio visual methods', 'Chemotherapy', 'education with a booklet (usual care), while the intervention group received prechemotherapy education using audio visual materials']","['distress scores', 'distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.030928,The effect of prechemotherapy education in each group was in the control group (p = 0.004) and the intervention group (p = 0.000).,"[{'ForeName': 'Alfonsius Ade', 'Initials': 'AA', 'LastName': 'Wirawan', 'Affiliation': 'Magister of Nursing, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Susanna Hilda', 'Initials': 'SH', 'LastName': 'Hutajulu', 'Affiliation': 'Division of Hematology and Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr Sardjito General Hospital, Yogyakarta, Indonesia.'}, {'ForeName': 'Haryani', 'Initials': 'H', 'LastName': 'Haryani', 'Affiliation': 'Department of Medical Surgical Nursing, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Jl. Farmako, Senolowo, Sinduadi, Kec. Mlati, Kabupaten Sleman, Daerah Istimewa, Yogyakarta, 55281, Indonesia. Haryani@ugm.ac.id.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01830-1']
73,32798360,Beyond diabetes mellitus: role of metformin in non-muscle-invasive bladder cancer.,"INTRODUCTION


Usage of metformin is associated with improved survival in lung, breast and prostate cancer, and metformin has been shown to inhibit cancer cell growth and proliferation in in vitro studies. Given the lack of clinical data on metformin use in patients with bladder cancer, we aimed to evaluate the role of metformin in their oncological outcomes.
METHODS


Medication use data from a prospectively maintained database of 122 patients with non-muscle-invasive bladder cancer treated with intravesical Bacille Calmette-Guerin (BCG), who were recruited under a randomised, double-blinded, controlled clinical trial, was collected and analysed. Kaplan-Meier curves were used to assess overall survival (OS) and disease-specific survival (DSS).
RESULTS


At a median follow-up duration of 102 (range 3-357) months, 53 (43.4%) patients experienced disease recurrence and 21 (17.2%) experienced disease progression. There was no significant difference in mortality between patients with and without diabetes mellitus. There was significant difference in OS between patients without diabetes mellitus, patients with diabetes mellitus on metformin and patients with diabetes mellitus but not on metformin (p = 0.033); patients with diabetes mellitus on metformin had the best prognosis. Metformin use was associated with significantly lower DSS (p = 0.042). Other oral hypoglycaemic agents, insulin or statins were not associated with disease recurrence or progression.
CONCLUSION


Metformin use was associated with improved oncological outcomes in patients with non-muscle-invasive bladder cancer treated with intravesical BCG. Prospective studies with larger patient populations are needed to validate the role of metformin as potential therapy for bladder cancer.",2022,Metformin use was associated with improved oncological outcomes in patients with non-muscle invasive bladder cancer treated with intravesical BCG.,"['patients with bladder cancer', 'patients with non-muscle invasive bladder cancer treated with', 'patients with diabetes mellitus', '122 patients with non-muscle invasive bladder cancer treated with', 'non-muscle invasive bladder cancer', 'Beyond diabetes mellitus']","['Metformin', 'intravesical Bacille Calmette-Guerin (BCG', 'metformin', 'intravesical BCG']","['OS', 'disease recurrence', 'disease progression', 'lower DSS', 'oncological outcomes', 'overall survival (OS) and disease-specific survival (DSS', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",122.0,0.037749,Metformin use was associated with improved oncological outcomes in patients with non-muscle invasive bladder cancer treated with intravesical BCG.,"[{'ForeName': 'Ziting', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Wilson Ying Fa', 'Initials': 'WYF', 'LastName': 'Ong', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Jen-Hwei', 'Initials': 'JH', 'LastName': 'Sng', 'Affiliation': 'Department of Urology, National University of Singapore, Singapore.'}, {'ForeName': 'Raman Mani', 'Initials': 'RM', 'LastName': 'Lata', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Ratha', 'Initials': 'R', 'LastName': 'Mahendran', 'Affiliation': 'Department of Urology, National University of Singapore, Singapore.'}, {'ForeName': 'Esuvaranathan', 'Initials': 'E', 'LastName': 'Kesavan', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Chiong', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}]",Singapore medical journal,['10.11622/smedj.2020121']
74,32829456,Pilot Study of a Virtual Reality Educational Intervention for Radiotherapy Patients Prior to Initiating Treatment.,"Virtual reality (VR) presents opportunities for innovative patient educational methods. This study used a combination of subjective questionnaires and objective physiological measures to investigate the impact of a VR radiotherapy (RT) educational system on patients' understanding and anxiety prior to commencing RT. Sixty patients were randomized to control (n = 30) and intervention (n = 30) groups prior to initiating RT. The control group received the standard nursing care process. The intervention group additionally participated in a detailed introduction to RT positioning, procedures, treatments, and other RT-related information via VR education. All patients completed a data collection from pre- and postintervention, which included questions on RT comprehension, anxiety-related scales, and objective physiological data reflecting the patient's psychological state, such as blood pressure, heart rate, and respiration. Both groups had high anxiety levels before the intervention, and there was no significant difference between the questionnaire and physiological data of the two groups. Following the intervention, anxiety scores (state-trait anxiety scale and visual analog scale) of the intervention group decreased significantly compared with those of the control group, and there was a significant decrease in systolic blood pressure (p < 0.05) and increase in cognitive score (p < 0.05). This study reports the positive impact of a virtual reality radiotherapy (VRRT) patient educational system on increasing patient RT comprehension and reducing anxiety. Further work is needed to improve the acceptability of the system to patients and to explore further the impact of VR education on patients' psychological and physical needs.",2022,"Following the intervention, anxiety scores (state-trait anxiety scale and visual analog scale) of the intervention group decreased significantly compared with those of the control group, and there was a significant decrease in systolic blood pressure (p < 0.05) and increase in cognitive score (p < 0.05).","[""patients' understanding and anxiety prior to commencing RT"", 'Sixty patients']","['Virtual Reality Educational Intervention', 'Virtual reality (VR', 'VR radiotherapy (RT) educational system', 'virtual reality radiotherapy (VRRT) patient educational system', 'standard nursing care process']","[""RT comprehension, anxiety-related scales, and objective physiological data reflecting the patient's psychological state, such as blood pressure, heart rate, and respiration"", 'cognitive score', 'systolic blood pressure', 'patient RT comprehension and reducing anxiety', 'anxiety scores (state-trait anxiety scale and visual analog scale', 'high anxiety levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",60.0,0.0199379,"Following the intervention, anxiety scores (state-trait anxiety scale and visual analog scale) of the intervention group decreased significantly compared with those of the control group, and there was a significant decrease in systolic blood pressure (p < 0.05) and increase in cognitive score (p < 0.05).","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qingmin', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Mengya', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Engineering, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. whuhcce@163.com.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01848-5']
75,32844674,Virtual Scribe Services Decrease Documentation Burden Without Affecting Patient Satisfaction: A Randomized Controlled Trial.,"BACKGROUND


Virtual scribe services (VSS) are a contemporary take on the in-person scribes utilized as a means to reduce administrative burden on physicians and enhance the physician-patient interaction. The purpose of this study was to determine whether VSS use could decrease the time an orthopaedic foot and ankle surgeon spends on documentation without diminishing the patient experience as compared with traditional postencounter dictation (TD).
METHODS


Fifty patients presenting for first-time visits with a single orthopaedic foot and ankle surgeon were prospectively enrolled and randomized to VSS or TD prior to the physician-patient encounter. Time spent with the patient in the exam room and time spent documenting away from the patient were recorded. A postencounter survey assessed patient satisfaction, perception of physician empathy, understanding of the plan, and perception of the amount of time spent with the physician.
RESULTS


Of 50 patients enrolled, 25 were randomized to VSS. Time spent documenting away from the patient differed significantly between VSS and TD (1.2 ± 0.7 minutes for VSS vs 5.8 ± 1.7 minutes for TD,  P  < .001) as did time elapsed between the end of the visit and the start of dictation (0 ± 0 for VSS vs 118.2 ± 72.7 minutes for TD,  P  < .001). There was a trend toward more time spent with the patient in the VSS group than in the TD group (14.2 ± 5.9 minutes for VSS vs 11.4 ± 5.1 minutes for TD,  P  = .069). There were no differences between groups in survey responses regarding satisfaction, empathy, understanding, or perception of sufficient time spent with the physician ( P  > .05 for each).
CONCLUSIONS


VSS use in an orthopaedic foot and ankle practice significantly decreased documentation time and allowed for completion of documentation during patient visits without differences in quality metrics as compared to TD. Orthopaedic surgeons can consider VSS a HIPAA-compliant documentation option with time savings and no measurable difference in patient satisfaction.
LEVELS OF EVIDENCE


Level II: Randomized controlled trial.",2022,"Orthopaedic surgeons can consider VSS a HIPAA-compliant documentation option with time savings and no measurable difference in patient satisfaction.
","['50 patients enrolled, 25 were randomized to VSS', 'Fifty patients presenting for first-time visits with a single orthopaedic foot and ankle surgeon', 'Patient Satisfaction']","['VSS', 'VSS or TD', 'traditional postencounter dictation (TD']","['satisfaction, empathy, understanding, or perception of sufficient time spent with the physician', 'patient satisfaction, perception of physician empathy, understanding of the plan, and perception of the amount of time spent with the physician', 'documentation time', 'Time spent', 'time spent']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}]",50.0,0.0832799,"Orthopaedic surgeons can consider VSS a HIPAA-compliant documentation option with time savings and no measurable difference in patient satisfaction.
","[{'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Benko', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Idarraga', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Bohl', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Kamran S', 'Initials': 'KS', 'LastName': 'Hamid', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois.'}]",Foot & ankle specialist,['10.1177/1938640020950544']
76,32876469,High Pleural Pressure Prevents Alveolar Overdistension and Hemodynamic Collapse in Acute Respiratory Distress Syndrome with Class III Obesity. A Clinical Trial.,"Rationale:  Obesity is characterized by elevated pleural pressure (Ppl) and worsening atelectasis during mechanical ventilation in patients with acute respiratory distress syndrome (ARDS). Objectives:  To determine the effects of a lung recruitment maneuver (LRM) in the presence of elevated Ppl on hemodynamics, left and right ventricular pressure, and pulmonary vascular resistance. We hypothesized that elevated Ppl protects the cardiovascular system against high airway pressure and prevents lung overdistension. Methods:  First, an interventional crossover trial in adult subjects with ARDS and a body mass index ≥ 35 kg/m 2  ( n  = 21) was performed to explore the hemodynamic consequences of the LRM. Second, cardiovascular function was studied during low and high positive end-expiratory pressure (PEEP) in a model of swine with ARDS and high Ppl ( n  = 9) versus healthy swine with normal Ppl ( n  = 6). Measurements and Main Results:  Subjects with ARDS and obesity (body mass index = 57 ± 12 kg/m 2 ) after LRM required an increase in PEEP of 8 (95% confidence interval [95% CI], 7-10) cm H 2 O above traditional ARDS Network settings to improve lung function, oxygenation and [Formula: see text]/[Formula: see text] matching, without impairment of hemodynamics or right heart function. ARDS swine with high Ppl demonstrated unchanged transmural left ventricular pressure and systemic blood pressure after the LRM protocol. Pulmonary arterial hypertension decreased (8 [95% CI, 13-4] mm Hg), as did vascular resistance (1.5 [95% CI, 2.2-0.9] Wood units) and transmural right ventricular pressure (10 [95% CI, 15-6] mm Hg) during exhalation. LRM and PEEP decreased pulmonary vascular resistance and normalized the [Formula: see text]/[Formula: see text] ratio. Conclusions:  High airway pressure is required to recruit lung atelectasis in patients with ARDS and class III obesity but causes minimal overdistension. In addition, patients with ARDS and class III obesity hemodynamically tolerate LRM with high airway pressure.Clinical trial registered with www.clinicaltrials.gov (NCT02503241).",2021,ARDS swine with high P PL  demonstrated unchanged transmural left ventricle pressure and systemic blood pressure after LRM protocol.,"['patients with ARDS and class III obesity tolerate', 'adult subjects with ARDS and BMI ≥35 kg/m 2  (n=21', 'patients with ARDS and class III obesity but causes minimal overdistension', 'Pulmonary artery hypertension decreased 8[13, 4', 'ARDS with Class III Obesity', 'patients with acute respiratory distress syndrome (ARDS', 'hemodynamically LRM with high airway pressure']","['lung recruitment maneuver (LRM', 'LRM and PEEP']","['cardiovascular function', 'transmural left ventricle pressure and systemic blood pressure', 'pulmonary vascular resistance and normalized ventilation/perfusion ratio', 'hemodynamics, left and right ventricular pressures and pulmonary vascular resistance', 'lung function, oxygenation and ventilation/perfusion matching, without impairment of hemodynamics or right heart function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1320796', 'cui_str': 'High airway pressure'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0522497', 'cui_str': 'Transmural'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0456166', 'cui_str': 'Right ventricular pressure'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0225808', 'cui_str': 'Structure of right side of heart'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0392421,ARDS swine with high P PL  demonstrated unchanged transmural left ventricle pressure and systemic blood pressure after LRM protocol.,"[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'De Santis Santiago', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Teggia Droghi', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Fumagalli', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Marrazzo', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Florio', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Luigi G', 'Initials': 'LG', 'LastName': 'Grassi', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Susimeire', 'Initials': 'S', 'LastName': 'Gomes', 'Affiliation': 'Divisao de Pneumologia, Instituto do Coração, Hospital das Clinícas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil; and.'}, {'ForeName': 'Caio C A', 'Initials': 'CCA', 'LastName': 'Morais', 'Affiliation': 'Divisao de Pneumologia, Instituto do Coração, Hospital das Clinícas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil; and.'}, {'ForeName': 'Ozires P S', 'Initials': 'OPS', 'LastName': 'Ramos', 'Affiliation': 'Divisao de Pneumologia, Instituto do Coração, Hospital das Clinícas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil; and.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Bottiroli', 'Affiliation': 'Department of Anesthesia and Critical Care, Niguarda Hospital and University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pinciroli', 'Affiliation': 'Department of Anesthesia and Critical Care, Niguarda Hospital and University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Imber', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Aranya', 'Initials': 'A', 'LastName': 'Bagchi', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Shelton', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Sonny', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Bittner', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Marcelo B P', 'Initials': 'MBP', 'LastName': 'Amato', 'Affiliation': 'Divisao de Pneumologia, Instituto do Coração, Hospital das Clinícas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil; and.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Kacmarek', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Berra', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201909-1687OC']
77,31029475,Pain management after photorefractive keratectomy.,"PURPOSE


To evaluate the effect of a bandage contact lens soaked in ketorolac ophthalmic 0.45% solution (Acuvail) on pain modulation in patients having transepithelial photorefractive keratectomy (PRK).
DESIGN


Prospective case series.
SETTING


Narayana Nethralaya Superspeciality Eye Hospital, Bangalore, India.
METHODS


Eyes of patients were divided into 2 groups. After transepithelial PRK, a regular soft bandage contact lens was placed in Group 1 and a ketorolac-soaked bandage contact lens was placed in Group 2. The patients were matched for age and sex in the 2 groups. Postoperative pain was compared using the validated Wong-Baker pain scale. Before placement of a ketorolac-soaked bandage contact lens in patients' eyes, the safety of the procedure was checked using cultures from the bandage contact lens and measuring the quantity of the drug adsorbed and the elution profile over time with ultra-high-performance liquid chromatography (UHPLC).
RESULTS


Each group comprised 35 eyes of 35 patients. The mean pain score was 7.95 ± 2.12 (SD) in Group 1, which was significantly higher than in Group 2 (2.76 ± 0.85), which received the ketorolac-soaked bandage contact lens. The UHPLC results showed that the soaked bandage contact lens acted as a depot for ketorolac, which was released onto the ocular surface over time, providing postoperative pain relief without causing adverse events.
CONCLUSION


A bandage contact lens soaked in ketorolac 0.45% solution can act as a potential drug depot that can reduce pain after transepithelial PRK.",2019,"The mean pain score was 7.95 ± 2.12 (SD) in Group 1, which was significantly higher than in Group 2 (2.76 ± 0.85), which received the ketorolac-soaked bandage contact lens.","['Narayana Nethralaya Superspeciality Eye Hospital, Bangalore, India', 'patients having transepithelial photorefractive keratectomy (PRK', ""patients' eyes"", 'Eyes of patients were divided into 2 groups', 'Pain management after photorefractive keratectomy']","['ketorolac-soaked bandage contact lens', 'bandage contact lens soaked in ketorolac ophthalmic 0.45% solution (Acuvail']","['mean pain score', 'pain modulation', 'Postoperative pain']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0717876', 'cui_str': 'Ketorolac-containing product in ocular dose form'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2718635', 'cui_str': 'Acuvail'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",35.0,0.0235251,"The mean pain score was 7.95 ± 2.12 (SD) in Group 1, which was significantly higher than in Group 2 (2.76 ± 0.85), which received the ketorolac-soaked bandage contact lens.","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Shetty', 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India.'}, {'ForeName': 'Ritika', 'Initials': 'R', 'LastName': 'Dalal', 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India.'}, {'ForeName': 'Archana Padmanabhan', 'Initials': 'AP', 'LastName': 'Nair', 'Affiliation': 'GROW Research Laboratory, Narayana Nethralaya Foundation, Bangalore, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Khamar', 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': ""D'Souza"", 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India. Electronic address: drsharondsouza@gmail.com.'}, {'ForeName': 'Ravish', 'Initials': 'R', 'LastName': 'Vaishnav', 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.01.032']
78,32962509,Non-immersive 3D virtual stimulus alter the time production task performance and increase the EEG theta power in dorsolateral prefrontal cortex.,"AIM


The study investigated the cortical activity changes and time production task performance induced by changes in motion speed of a non-immersive 3D virtual stimulus.
MATERIAL AND METHODS


Twenty-one individuals were participated in the crossover study with the visual-time reproduction task under three-speed conditions: original, slow and fast virtual stimulus. In addition, the electroencephalographic analysis of the theta band power in the dorsolateral prefrontal cortex was done simultaneously with time production task execution.
RESULTS


The results demonstrated that in the slow speed condition, there is an increase in the error in the time production task after virtual reality ( p  < 0.05). There is also increased EEG theta power in the right dorsolateral prefrontal cortex in all speed conditions ( p  < 0.05).
CONCLUSIONS


We propose that the modulations of speed of virtual stimulus may underlie the accumulation of temporal pulses, which could be responsible for changes in the performance of the production task of the time intervals and a substantial increase in right dorsolateral prefrontal cortex activity related to attention and memory, acting in cognitive domains of supraseconds.",2022,There is also increased EEG theta power in the right dorsolateral prefrontal cortex in all speed conditions (p < 0.05).  ,"['Twenty-one individuals were participated in the crossover study with the visual-time reproduction task under three-speed conditions: original, slow and fast virtual stimulus']",['Material and Methods '],"['cortical activity changes and time production task performance', 'time production task', 'EEG theta power', 'time production task performance']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",21.0,0.0239566,There is also increased EEG theta power in the right dorsolateral prefrontal cortex in all speed conditions (p < 0.05).  ,"[{'ForeName': 'Diandra Caroline', 'Initials': 'DC', 'LastName': 'Martins E Silva', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Marinho', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Silmar', 'Initials': 'S', 'LastName': 'Teixeira', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Teles', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Marques', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Escórcio', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Thayaná', 'Initials': 'T', 'LastName': 'Fernandes', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'Freitas', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Monara', 'Initials': 'M', 'LastName': 'Nunes', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Ayres', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Ayres', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Juliana Bittencourt', 'Initials': 'JB', 'LastName': 'Marques', 'Affiliation': 'Laboratory of Neurophysiology and Neuropsychology of Attention, Veiga de Almeida University, Cabo Frio, Brazil.'}, {'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Cagy', 'Affiliation': 'Masters and PhD Program in Biomedical Engineering, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Daya S', 'Initials': 'DS', 'LastName': 'Gupta', 'Affiliation': 'Department of Biology, Camden County College, Blackwood, NJ, USA.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'Bastos', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1826945']
79,32978034,Neurocognitive and social cognitive training for youth at clinical high risk (CHR) for psychosis: A randomized controlled feasibility trial.,"BACKGROUND


Cognitive deficits are present in individuals at clinical high risk for psychosis (CHRP). We developed Cognition for Learning and for Understanding Everyday Social Situations (CLUES), an integrated social- and neurocognitive remediation intervention for CHRP, and examined its feasibility and efficacy compared to an active control intervention in a pilot randomized controlled trial.
METHOD


Thirty-eight individuals at CHR-P were randomized to CLUES or Enriched Acceptance and Commitment Therapy (EnACT). Participants were assessed at baseline, end of treatment and 3-month follow-up for changes in social/role functioning, neuro- and social cognition, and symptoms.
RESULTS


Social functioning significantly improved for participants in CLUES over EnACT, at end of treatment and 3-month follow-up. CLUES participants also showed greater improvements in social cognition (theory of mind and managing emotions).
CONCLUSION


The results support feasibility of CLUES and suggest preliminary efficacy. Future randomized controlled trials of CLUES in a larger sample, with additional treatment sites, could help determine efficacy of CLUES, and investigate whether CLUES can be effectively implemented in other settings.",2022,"Participants were assessed at baseline, end of treatment and 3-month follow-up for changes in social/role functioning, neuro- and social cognition, and symptoms.
","['Thirty-eight individuals at CHR-P', 'individuals at clinical high risk for psychosis (CHRP', 'youth at clinical high risk (CHR) for psychosis']","['CLUES', 'CLUES or Enriched Acceptance and Commitment Therapy (EnACT', 'Neurocognitive and social cognitive training']","['social cognition (theory of mind and managing emotions', 'Social functioning', 'social/role functioning, neuro- and social cognition, and symptoms']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043459', 'cui_str': 'Zellweger syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0772979,"Participants were assessed at baseline, end of treatment and 3-month follow-up for changes in social/role functioning, neuro- and social cognition, and symptoms.
","[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Friedman-Yakoobian', 'Affiliation': 'Public Psychiatry Division of Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, MA 02115, United States of America. Electronic address: mfriedm3@bidmc.harvard.edu.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Parrish', 'Affiliation': 'Public Psychiatry Division of Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, MA 02115, United States of America.'}, {'ForeName': 'Shaun M', 'Initials': 'SM', 'LastName': 'Eack', 'Affiliation': 'University of Pittsburgh, School of Social Work and Department of Psychiatry, United States of America.'}, {'ForeName': 'Matcheri S', 'Initials': 'MS', 'LastName': 'Keshavan', 'Affiliation': 'Public Psychiatry Division of Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, MA 02115, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2020.09.005']
80,32894418,Internet-Delivered Cognitive Behavioral Therapy and Psychoeducation Program for Patients with Gastrointestinal Stromal Tumors.,"Gastrointestinal stromal tumors (GIST) account for 0.2-3% of all cancer diagnoses and are thus considered a rare type of cancer. Severe levels of fatigue occur in 33% of patients on imatinib, but besides treatment, fatigue is also associated with psychological distress. As far as we know, only one previous study has reported on the design of a psychoeducational intervention for caregivers and patients with GIST. The current study was conducted to compare the preliminary effectiveness of an Internet-delivered cognitive behavioral stress management intervention and psychoeducation program for anxiety, depression, fatigue, and quality of life in patients with gastrointestinal stromal tumors (GIST). This study had an experimental pre-test post-test design with a control group. Ninety-nine patients were randomly allocated to an Internet-delivered cognitive program (n = 50) or psychoeducation control group (n = 49). Participants completed the questionnaires at three time points (pre-test, post-test, and 3-month follow-up). Twenty-seven participants completed the intervention. A significant interaction effect between groups and time was found for general fatigue [F(2, 28) = 8.2, p < 0.001, ƞ 2 p  = 0.25], reduced motivation [F(2, 28) = 3.5, p < 0.05, ƞ 2 p  = 0.12], distress [F(2, 28) = 3.4, p < 0.05, ƞ 2 p  = 0.12], and global health status [F(2, 28) = 3.8, p < 0.05, ƞ 2 p  = 0.13]. Both intervention programs showed reductions in the dimensions of fatigue and improvements in distress and dimensions of quality of life. Additional research on a larger sample size is needed to confirm the effects obtained in this study.",2022,Both intervention programs showed reductions in the dimensions of fatigue and improvements in distress and dimensions of quality of life.,"['caregivers and patients with GIST', 'Ninety-nine patients', 'Patients with Gastrointestinal Stromal Tumors', 'patients with gastrointestinal stromal tumors (GIST']","['Internet-Delivered Cognitive Behavioral Therapy and Psychoeducation Program', 'Internet-delivered cognitive program (n\u2009=\u200950) or psychoeducation control group', 'psychoeducational intervention', 'Internet-delivered cognitive behavioral stress management intervention and psychoeducation program']","['anxiety, depression, fatigue, and quality of life', 'Severe levels of fatigue occur', 'Gastrointestinal stromal tumors (GIST) account', 'dimensions of fatigue and improvements in distress and dimensions of quality of life', 'global health status']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C3828813', 'cui_str': '99'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",99.0,0.0256986,Both intervention programs showed reductions in the dimensions of fatigue and improvements in distress and dimensions of quality of life.,"[{'ForeName': 'Edelmira Berenice', 'Initials': 'EB', 'LastName': 'Carbajal-López', 'Affiliation': 'Psychology School, Fundación GIST Mexico, Universidad Autónoma de Nuevo León, Monterrey, Mexico.'}, {'ForeName': 'Dehisy Marisol', 'Initials': 'DM', 'LastName': 'Juárez-García', 'Affiliation': 'Psychology School, Universidad Autónoma de Nuevo León, Monterrey, Mexico. dehisy_jg@yahoo.com.mx.'}, {'ForeName': 'Absalón', 'Initials': 'A', 'LastName': 'Espinoza-Velazco', 'Affiliation': 'UMAE High Specialty Hospital 25, Instituto Mexicano del Seguro Social, Monterrey, Mexico.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Calderillo-Ruiz', 'Affiliation': 'Instituto Nacional de Cancerología, Ciudad de México, Mexico.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01866-3']
81,32962461,The role of a neonatal hypothermia alert device in promoting weight gain in LBW infants.,"BACKGROUND


Neonatal hypothermia is a significant risk factor for preterm and low birth weight (LBW) newborns, especially in India. Kangaroo Mother Care (KMC) is one recommended method of thermal control. A wearable device, TempWatch, has been developed to monitor for and detect hypothermia and to promote KMC for preterm and LBW infants.
PURPOSE


This randomized controlled trial was designed to evaluate TempWatch's impact on weight gain, amount of KMC received, and length of hospital stay for LBW infants as compared to standard care.
METHODS


Otherwise healthy LBW infants (with birthweights 1500-2300 g) admitted to a KMC ward of a government hospital in New Delhi, India were randomly allocated to a TempWatch group or a control group and wore the device until their time of discharge. 50 infants were enrolled in each group. All participants received standard-of-care temperature monitoring, and those in the control group were monitored using the hand-touch method. Each group also received sixth-hourly temperature monitoring. Infants' daily weight and the number of hypothermia episodes they experienced per day were recorded, and mothers of infants in both groups completed daily KMC diaries.
RESULTS


The TempWatch group experienced statistically significant weight gain as compared to the control group (0.06 vs. 0.02 kg,  p  = .024). There were no statistically significant differences between the groups in the number of hypothermia events detected, the amount of KMC received.
CONCLUSION


TempWatch promotes statistically significant weight gain for LBW infants as compared to standard care.",2022,"There were no statistically significant differences between the groups in the number of hypothermia events detected, the amount of KMC received.
","['LBW infants', 'Otherwise healthy LBW infants (with birthweights 1500-2300\u2009g) admitted to a KMC ward of a government hospital in New Delhi', '50 infants were enrolled in each group']","['Kangaroo Mother Care (KMC', 'neonatal hypothermia alert device']","['number of hypothermia events', 'weight gain, amount of KMC received, and length of hospital stay', ""Infants' daily weight and the number of hypothermia episodes"", 'weight gain']","[{'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0919592', 'cui_str': 'Hypothermia neonatal'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",50.0,0.0646981,"There were no statistically significant differences between the groups in the number of hypothermia events detected, the amount of KMC received.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Azad', 'Affiliation': 'Department of Pediatrics, Swami Dayanand Hospital, New Delhi, India.'}, {'ForeName': 'Surender Singh', 'Initials': 'SS', 'LastName': 'Bisht', 'Affiliation': 'Department of Pediatrics, Swami Dayanand Hospital, New Delhi, India.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Tyagi', 'Affiliation': 'Department of Pediatrics, Swami Dayanand Hospital, New Delhi, India.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Jaipal', 'Affiliation': 'Department of Pediatrics, Swami Dayanand Hospital, New Delhi, India.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1814244']
82,32962477,Glucagon-like peptide-1 receptor agonist liraglutide therapy for psoriasis patients with type 2 diabetes: a randomized-controlled trial.,"OBJECTIVE


There were some clinical studies on GLP-1R agonist liraglutide therapy for psoriasis patients with type 2 diabetes, but there is a lack of randomized controlled trials and the mechanism of which remains unclear.
METHOD


A total of 25 psoriasis patients with type 2 diabetes were randomized 1: 1 divided into the control group ( n  = 13) or liraglutide group ( n  = 12) for 12 weeks. We determined the PASI, the DLQI, histopathology of psoriasis skin, and the expression of IL-17, IL-23, and TNF-α in the psoriasis skin.
RESULTS


After 12 weeks of treatment, the mean DLQI of the treatment group decreased from 22.00 ± 5.85 to 3.82 ± 3.60 ( p  < .05). Compared to week 12, the change in the baseline value of PASI and DLQI in the treatment group showed a significant difference compared with the control group ( p  < .05). The pathological changes of psoriasis skin and the expression of IL-17, IL-23, TNF-α in the psoriasis skin were improved in the treatment group. No serious adverse events occurred.
CONCLUSION


The skin lesions in psoriasis patients with type 2 diabetes were significantly improved after treatment with liraglutide, which may be related to the inhibition of the expression of inflammatory factors such as IL-23, IL-17, and TNF-α.",2022,"The pathological changes of psoriasis skin and the expression of IL-17, IL-23, TNF-α in the psoriasis skin were improved in the treatment group.","['25 psoriasis patients with type 2 diabetes', 'psoriasis patients with type 2 diabetes']","['liraglutide', 'GLP-1R agonist liraglutide therapy', 'Glucagon-like peptide-1 receptor agonist liraglutide therapy']","['mean DLQI', 'pathological changes of psoriasis skin and the expression of IL-17, IL-23, TNF-α in the psoriasis skin', 'baseline value of PASI and DLQI', 'skin lesions']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}]",25.0,0.0251982,"The pathological changes of psoriasis skin and the expression of IL-17, IL-23, TNF-α in the psoriasis skin were improved in the treatment group.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Yunjie', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Hongjiang', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Xiaoqiong', 'Initials': 'X', 'LastName': 'He', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Shengping', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Xaingqi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Zhulin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1826392']
83,32997948,The effect of music on pain sensitivity in healthy adults.,"BACKGROUND


Previous work suggests mediating effects of music on acute pain processing. This quasi-experimental pilot study examined the effects of music on experimental pain sensitivity.
METHODS


Healthy adults ( N  = 40) completed quantitative sensory tests during three music conditions (silence, listening, and singing). Repeated Measures ANOVA , Friedman's Test, and post hoc comparisons determined differences in pain intensity and time to cold pain threshold and tolerance between conditions.. Pearson partial correlations evaluated the association of musical factorswith pain sensitivity.
RESULTS


Participants demonstrated longer time intervals until perceiving pain and tolerated pain for longer durations when singing compared to listening. Greater self-reported singing proficiency was associated with higher tolerance. Several musical factors were significantly correlated with time from pain threshold to reaching tolerance.
CONCLUSION


Singing during an acute painful stimulus may increase tolerance. Various musical characteristics impact volunteers' central pain responses and singing may be an important adjunct pain management strategy.",2022,Greater self-reported singing proficiency was associated with higher tolerance.,"['healthy adults', 'Healthy adults ( N  =\xa040) completed']","['quantitative sensory tests during three music conditions (silence, listening, and singing']","['pain sensitivity', 'pain intensity and time to cold pain threshold and tolerance', 'longer time intervals until perceiving pain and tolerated pain']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.176613,Greater self-reported singing proficiency was associated with higher tolerance.,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'LiKamWa', 'Affiliation': 'Pain Research and Intervention Center of Excellence, The University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Josue', 'Initials': 'J', 'LastName': 'Cardoso', 'Affiliation': 'Pain Research and Intervention Center of Excellence, The University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Sonke', 'Affiliation': 'Center for the Arts in Medicine, The University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Pain Research and Intervention Center of Excellence, The University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Staja Q', 'Initials': 'SQ', 'LastName': 'Booker', 'Affiliation': 'College of Nursing, The University of Florida, Gainesville, FL, USA.'}]",Arts & health,['10.1080/17533015.2020.1827278']
84,33501845,Working memory training in pediatric brain tumor survivors after recent diagnosis: Challenges and initial effects.,"Research shows promise for cognitive interventions for children diagnosed with brain tumors. Interventions have been delivered approximately 5 years postdiagnosis on average, yet recent evidence shows cognitive deficits may appear near diagnosis. The present study assessed the feasibility and initial effects of working memory training in children with brain tumors delivered soon after diagnosis and followed 2 years postdiagnosis. Children completed baseline assessments 10 months postdiagnosis and were randomized to complete adaptive or nonadaptive (i.e., control) Cogmed Working Memory Training. Children were administered the WISC-IV Working Memory Index (WMI) and NIH Toolbox Cognitive Battery (NTCB), and parents completed attentional and executive function measures at four time points. On average, participants completed half of prescribed Cogmed sessions. Retention for the three follow-up assessments proved difficult. For both Cogmed groups, WMI and NTCB scores significantly improved immediately postintervention compared to baseline scores. Significant differences were not maintained at the remaining follow-ups. There was preliminary evidence for improved executive function at the final follow-up on parent-reported measures. Working memory training closer to diagnosis proved difficult, though results suggest evidence of cognitive improvement. Future studies should continue to examine potentially efficacious interventions for children with brain tumors and optimal delivery windows to maximize impact.",2022,"For both Cogmed groups, WMI and NTCB scores significantly improved immediately postintervention compared to baseline scores.","['children with brain tumors', 'children with brain tumors delivered soon after diagnosis and followed 2 years postdiagnosis', 'children diagnosed with brain tumors', 'pediatric brain tumor survivors']","['complete adaptive or nonadaptive (i.e., control', 'Working memory training', 'Cogmed Working Memory Training', 'working memory training']","['WMI and NTCB scores', 'executive function', 'WISC-IV Working Memory Index (WMI) and NIH Toolbox Cognitive Battery (NTCB), and parents completed attentional and executive function measures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0582651,"For both Cogmed groups, WMI and NTCB scores significantly improved immediately postintervention compared to baseline scores.","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Siciliano', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Thigpen', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Leandra', 'Initials': 'L', 'LastName': 'Desjardins', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Cook', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Ellen H', 'Initials': 'EH', 'LastName': 'Steele', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Gruhn', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Ichinose', 'Affiliation': 'Department of Psychology, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Psychology, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Esbenshade', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Devang', 'Initials': 'D', 'LastName': 'Pastakia', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Wellons', 'Affiliation': 'Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Compas', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, Tennessee, USA.'}]",Applied neuropsychology. Child,['10.1080/21622965.2021.1875226']
85,33390056,The impact of methotrexate therapy with vitamin D supplementation on the cardiovascular risk factors among patients with psoriasis; a prospective randomized comparative study.,"BACKGROUND


Controlling psoriasis with various systemic treatments, including methotrexate, may significantly decrease associated cardiovascular risk problems.
OBJECTIVE


To assess the value of vitamin D supplementation on clinical response as well as changes in cardiovascular risk parameters in psoriasis patients treated with methotrexate.
METHODS


This prospective randomized comparative study included 30 patients with moderate to severe psoriasis divided randomly to receive either methotrexate alone (Mtx) or methotrexate plus intramuscular vitamin D (MtxD) for 3 months. Lipid profile, HsCRP, carotid intima-media thickness (CIMT) and blood pressure (BP) measurements were recorded before and after the therapy.
RESULTS


At end of study period, significant clinical improvement in both groups was observed. CIMT and systolic BP decreased in both groups but only statistically significant in Mtx group. HsCRP decreased in both groups but didn't reach statistical significance. We also observed, an increase in triglycerides and cholesterol levels in the Mtx group with the latter decreasing in the combined Mtx and vitamin D therapy group.
CONCLUSION


Treating psoriasis with methotrexate may decrease cardiovascular disease risk factors. Adding vitamin D supplementation to methotrexate may protect lipid homeostasis, specifically cholesterol and triglycerides.",2022,HsCRP decreased in both groups but didn't reach statistical significance.,"['patients with psoriasis', '30 patients with moderate to severe psoriasis', 'psoriasis patients treated with methotrexate']","['vitamin D therapy', 'methotrexate', 'vitamin D supplementation', 'methotrexate alone (Mtx) or methotrexate plus intramuscular vitamin D (MtxD', 'Methotrexate therapy with vitamin D supplementation']","['lipid homeostasis, specifically cholesterol and triglycerides', 'CIMT and systolic BP', 'HsCRP', 'triglycerides and cholesterol levels', 'cardiovascular risk factors', 'cardiovascular risk parameters', 'Lipid profile, HsCRP, carotid intima-media thickness (CIMT) and blood pressure (BP) measurements', 'cardiovascular disease risk factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",30.0,0.0233012,HsCRP decreased in both groups but didn't reach statistical significance.,"[{'ForeName': 'Ghada Mohamed', 'Initials': 'GM', 'LastName': 'El-Hanafy', 'Affiliation': 'Dermatology Department, Faculty of Medicine Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Hussein Medhat', 'Initials': 'MHM', 'LastName': 'El-Komy', 'Affiliation': 'Dermatology Department, Kasr Al-Ainy Psoriasis Unit, Faculty of Medicine Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mona Ali', 'Initials': 'MA', 'LastName': 'Nashaat', 'Affiliation': 'Department of Internal Medicine, Kasr Al-Ainy Vascular Lab, Faculty of Medicine Cairo University, Cairo, Egypt.'}, {'ForeName': 'Normeen Hany', 'Initials': 'NH', 'LastName': 'Rady', 'Affiliation': 'Clinical and Chemical Pathology Department, Faculty of Medicine Cairo University, Cairo, Egypt.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abd El-Salam', 'Affiliation': 'Dermatology Department, Faculty of Medicine Cairo University, Cairo, Egypt.'}, {'ForeName': 'Eman Raafat', 'Initials': 'ER', 'LastName': 'Said', 'Affiliation': 'Dermatology Department, Kasr Al-Ainy Psoriasis Unit, Faculty of Medicine Cairo University, Cairo, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2021.1871581']
86,33264686,"Metabolic and performance responses of male runners wearing 3 types of footwear: Nike Vaporfly 4%, Saucony Endorphin racing flats, and their own shoes.","PURPOSE


We compared running economy (RE) and 3-km time-trial (TT) variables of runners wearing Nike Vaporfly 4% (VP4), Saucony Endorphin lightweight racing flats (FLAT), and their habitual running (OWN) footwear.
METHODS


Eighteen male recreational runners (age = 33.5 ± 11.9 year (mean ± SD), peak oxygen uptake (VO 2peak ) = 55.8 ± 4.4 mL/kg·min) attended 4 sessions approximately 7 days apart. The first session consisted of a VO 2peak  test to inform subsequent RE speeds set at 60%, 70%, and 80% of the speed eliciting VO 2peak . In subsequent sessions, treadmill RE and 3-km TTs were assessed in the 3 footwear conditions in a randomized, counterbalanced crossover design.
RESULTS


Oxygen consumption (mL/kg·min) was less in VP4 (from 4.3% to 4.4%, p ≤ 0.002) and FLAT (from 2.7% to 3.4%, p ≤ 0.092) vs. OWN across intensities, with a non-significant difference between VP4 and FLAT (1.0%-1.7%, p ≥ 0.292). Findings related to energy cost (W/kg) and energetics cost of transport (J/kg·m) were comparable. VP4 3-km TT performance (11:07.6 ± 0:56.6 mm:ss) was enhanced vs. OWN by 16.6 s (2.4%, p = 0.005) and vs. FLAT by 13.0 s (1.8%, p = 0.032). The 3-km times between OWN and FLAT (0.5%, p = 0.747) were similar. Most runners (n = 11, 61%) ran their fastest TT in VP4.
CONCLUSION


Overall, VP4 improved laboratory-based RE measures in male recreational runners at relative speeds compared to OWN, but the RE improvements in VP4 were not significant vs. FLAT. More runners exhibited better treadmill TT performances in VP4 (61%) vs. FLAT (22%) and OWN (17%). The variability in RE (-10.3% to 13.3%) and TT (-4.7% to 9.3%) improvements suggests that responses to different types of shoes are individualized and warrant further investigation.",2022,"RESULTS


Oxygen consumption (mL/kg•min) was lesser in VP4 (from 4.3% to 4.4%, p ≤ 0.002) and FLAT (from 2.7% to 3.4%, p ≤ 0.092) vs. OWN across intensities, with a non-significant difference between VP4 and FLAT (1.0%-1.7%, p ≥ 0.292).","['male recreational runners', 'male runners wearing 3 types of footwear: Nike Vaporfly 4%, Saucony Endorphin racing flats, and their own shoes', 'runners wearing Nike Vaporfly 4% (VP4), Saucony Endorphin lightweight racing flats (FLAT), and their habitual running (OWN) footwear', 'Eighteen male recreational runners (age: 33.5 ± 11.9 year (mean ± SD), peak oxygen uptake (VO 2peak ): 55.8 ± 4.4']",[],"['VP4 3-km TT performance', 'VP4', 'Overall, VP4 improved laboratory-based RE measures', 'energy cost (W/kg) and energetics cost of transport (J/kg•m', 'FLAT', 'Oxygen consumption', 'variability in RE', 'Metabolic and performance responses', 'treadmill TT performances']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C4517761', 'cui_str': '4.4'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]",18.0,0.14862,"RESULTS


Oxygen consumption (mL/kg•min) was lesser in VP4 (from 4.3% to 4.4%, p ≤ 0.002) and FLAT (from 2.7% to 3.4%, p ≤ 0.092) vs. OWN across intensities, with a non-significant difference between VP4 and FLAT (1.0%-1.7%, p ≥ 0.292).","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hébert-Losier', 'Affiliation': 'Division of Health, Engineering, Computing and Science, Te Huataki Waiora School of Health, University of Waikato, Mount Maunganui, Tauranga 3116, New Zealand. Electronic address: kim.hebert-losier@waikato.ac.nz.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Finlayson', 'Affiliation': 'Division of Health, Engineering, Computing and Science, Te Huataki Waiora School of Health, University of Waikato, Mount Maunganui, Tauranga 3116, New Zealand.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Driller', 'Affiliation': 'Division of Health, Engineering, Computing and Science, Te Huataki Waiora School of Health, University of Waikato, Mount Maunganui, Tauranga 3116, New Zealand; Sport and Exercise Science, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC 3086, Australia.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Dubois', 'Affiliation': 'Research & Development, the Running Clinic, Lac-Beauport, QC G3B 2J8, Canada.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Esculier', 'Affiliation': 'Research & Development, the Running Clinic, Lac-Beauport, QC G3B 2J8, Canada.'}, {'ForeName': 'Christopher Martyn', 'Initials': 'CM', 'LastName': 'Beaven', 'Affiliation': 'Division of Health, Engineering, Computing and Science, Te Huataki Waiora School of Health, University of Waikato, Mount Maunganui, Tauranga 3116, New Zealand.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.11.012']
87,33285743,"A randomized, multi-center, open-label study to compare the safety and efficacy between afatinib monotherapy and combination therapy of afatinib and HAD-B1 for the locally advanced or metastatic NSCLC patients with EGFR mutations.","BACKGROUND


Afatinib is an epidermal growth factor receptor - tyrosine kinase inhibitor (EGFR-TKI) with proven efficacy for treating patients with advanced or metastatic non-small cell lung cancer (NSCLC). Unfortunately, responses are limited by acquired resistance. Because traditional Korean medicine may have synergistic effects when combined with chemotherapy or radiotherapy, the aim of our study is to elucidate the efficacy and safety of afatinib plus HangAmDan-B1 (HAD-B1) combination therapy in the treatment of patients with NSCLC, as well as EGFR mutations, who need afatinib therapy.
METHODS/DESIGN


This study is a randomized, multi-center, open clinical trial. A total of 178 eligible subjects, recruited at 8 centers, are randomly assigned to take Afatinib (20-40 mg) ± HAD-B1 (0.972 g/day) for 48 weeks. In the test group, HAD-B1 and afatinib will be used in combination. The primary outcome is a comparison of progression-free survival (PFS) between afatinib monotherapy and afatinib plus HAD-B1 combination therapy in patients with local advanced or metastatic (Stage IIIA, B, C/IV) NSCLC. Secondary outcomes are the overall survival rates, clinical responses, tumor size reductions, health-related qualities of life, and safety.
DISCUSSION


The result of this clinical trial will provide evidence for the efficacy and safety of using HAD-B1 in the treatment of EGFR-positive patients with locally advanced or metastatic NSCLC who require afatinib therapy.
TRIAL REGISTRATION


Clinical Research Information Service (CRIS), Republic of Korea (ID: KCT0005414), on September 23, 2020.",2020,"Secondary outcomes are the overall survival rates, clinical responses, tumor size reductions, health-related qualities of life, and safety.
","['EGFR-positive patients with locally advanced or metastatic NSCLC who require afatinib therapy', 'patients with NSCLC, as well as EGFR mutations, who need afatinib therapy', '178 eligible subjects, recruited at 8 centers', 'patients with local advanced or metastatic (Stage IIIA, B, C/IV) NSCLC', 'locally advanced or metastatic NSCLC patients with EGFR mutations', 'patients with advanced or metastatic non-small cell lung cancer (NSCLC']","['afatinib and HAD-B1', 'afatinib plus HAD-B1 combination therapy', 'afatinib plus HangAmDan-B1 (HAD-B1) combination therapy', 'Afatinib']","['comparison of progression-free survival (PFS', 'safety and efficacy', 'overall survival rates, clinical responses, tumor size reductions, health-related qualities of life, and safety']","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",178.0,0.19733,"Secondary outcomes are the overall survival rates, clinical responses, tumor size reductions, health-related qualities of life, and safety.
","[{'ForeName': 'Si-Yeon', 'Initials': 'SY', 'LastName': 'Song', 'Affiliation': 'East West Cancer Center, Daejeon Korean Medicine Hospital of Daejeon University, Daejeon.'}, {'ForeName': 'Su-Jeong', 'Initials': 'SJ', 'LastName': 'Ha', 'Affiliation': 'East West Cancer Center, Daejeon Korean Medicine Hospital of Daejeon University, Daejeon.'}, {'ForeName': 'Ji-Hye', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'East West Cancer Center, Seoul Korean Medicine Hospital of Daejeon University, Seoul.'}, {'ForeName': 'So-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'East West Cancer Center, Daejeon Korean Medicine Hospital of Daejeon University, Daejeon.'}, {'ForeName': 'Seong Hoon', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Pusan.'}, {'ForeName': 'Chulho', 'Initials': 'C', 'LastName': 'Oak', 'Affiliation': 'Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Pusan.'}, {'ForeName': 'Jun-Yong', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Korean Medicine & Korean Medicine Hospital of Pusan National University, Yangsan.'}, {'ForeName': 'Seong Woo', 'Initials': 'SW', 'LastName': 'Yoon', 'Affiliation': 'Korean Medicine Cancer Center, Kyung Hee University Hospital at Gangdong.'}, {'ForeName': 'Jung-A', 'Initials': 'JA', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Kyung Hee University Gangdong Hospital, Seoul.'}, {'ForeName': 'Seong Hoon', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan.'}, {'ForeName': 'Ji Woong', 'Initials': 'JW', 'LastName': 'Son', 'Affiliation': 'Department of Internal Medicine, Konyang University Hospital, Daejeon.'}, {'ForeName': 'Seung Joon', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, Postech-Catholic Biomedical Engineering Institute, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hwa-Seung', 'Initials': 'HS', 'LastName': 'Yoo', 'Affiliation': 'East West Cancer Center, Seoul Korean Medicine Hospital of Daejeon University, Seoul.'}]",Medicine,['10.1097/MD.0000000000023455']
88,33485836,Effectiveness of a Functional Rehabilitation Program for Upper Limb Apraxia in Poststroke Patients: A Randomized Controlled Trial.,"OBJECTIVE


To analyze the effectiveness of a home-based restorative and compensatory upper limb apraxia (ULA) rehabilitation program.
DESIGN


Randomized controlled trial.
SETTING


Neurology Unit of San Cecilio Hospital and 2 private and specialized health care centers.
PARTICIPANTS


Community dwelling participants (N=38) between the ages of 25 and 95 years old (sex ratio, 1:1) with unilateral mild-to-moderate poststroke lesions (time of evolution since stroke, 12.03±8.98mo) and secondary ULA.
INTERVENTIONS


Participants were randomly assigned to an 8-week combined ULA functional rehabilitation group (n=19) 3 days per week for 30 minutes or to a traditional health care education protocol group (n=19) once a month for 8 weeks. Both interventions were conducted at home.
MAIN OUTCOME MEASURES


Sociodemographic and clinical data, Barthel Index (primary outcome), Lawton and Brody Scale, observation and scoring activities of daily living, the De Renzi tests for ideational and ideomotor apraxia and imitating gestures test, recognition of gestures, test for upper limb apraxia , and stroke-specific quality of life scale were assessed at 3 time points: baseline, posttreatment (8wk), and follow-up (8wk).
RESULTS


There were statistically significant differences among the groups regarding ideomotor apraxia, imitating gestures, global recognition of gestures, intransitive gestures, and comprehension of gesture production (P<.05) in favor of the experimental group. However, no statistically significant differences were found between the groups regarding functionality or quality of life (P>.05). Regarding the within-group effect, statistically significant differences were found in all neuropsychological outcomes at posttreatment and follow-up (P<.05).
CONCLUSION


A functional rehabilitation program was found to be superior to a traditional health care education program and resulted in improvements in neuropsychological functioning in ULA poststroke. Conventional education showed an insufficient effect on apraxia recovery. Further studies with larger sample sizes are needed to determine the effect of rehabilitation strategies on functionality and quality of life of poststroke ULA patients.",2021,A functional rehabilitation program was superior to a traditional healthcare education program and resulted in improvements in the neuropsychological functioning in ULA poststroke.,"['38 community dwelling participants (25-95 years old, sex ratio 1:1) with unilateral mild-to-moderate poststroke lesions (time of evolution since stroke (months) 12.03±8.98) and secondary ULA', 'Neurology Unit of San Cecilio Hospital, and two private and specialized healthcare centers', 'poststroke ULA patients', 'upper limb apraxia in poststroke patients']","['functional rehabilitation program', 'traditional healthcare education protocol group', 'ULA functional rehabilitation', 'home-based restorative and compensatory upper limb apraxia (ULA) rehabilitation program']","['functionality or quality of life', 'recognition of gestures, TULIA, and stroke-specific quality of life scale (SSQOL-38', 'Sociodemographic and clinical data, Barthel Index (primary outcome), Lawton and Brody Scale, Observation and scoring-ADL, the De Renzi tests for ideational and ideomotor apraxia and imitating gestures test', 'neuropsychological outcomes', 'ideomotor apraxia, imitating gestures, global recognition of gestures, intransitive gestures, and comprehension of gesture production', 'apraxia recovery']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234523', 'cui_str': 'Classic apraxia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}]",38.0,0.0783492,A functional rehabilitation program was superior to a traditional healthcare education program and resulted in improvements in the neuropsychological functioning in ULA poststroke.,"[{'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain. Electronic address: encaguilar@hotmail.com.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Toledano-Moreno', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'García-Ríos', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Tapia-Haro', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Barrero-Hernández', 'Affiliation': 'Neurology División, San Cecilio Hospital, Granada, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Casas-Barragán', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Pérez-Mármol', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA. Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.12.015']
89,33356686,"Two-year follow-up of a dose reduction strategy trial of biologics adalimumab, etanercept, and ustekinumab in psoriasis patients in daily practice.","BACKGROUND/OBJECTIVES


Tightly-controlled dose reduction was possible during 1 year in psoriasis patients on adalimumab, etanercept or ustekinumab with low disease activity (CONDOR trial). Extended observation is needed to ensure long-term effectiveness and safety of the strategy. With prolonged follow-up, we investigated the clinical effects and safety of the strategy, the proportion of patients with successful dose reduction, and assessed if patients with a disease flare regained remission.
METHODS


Two-year follow up of a subgroup of patients previously included in a randomized pragmatic study comparing usual care (UC) with stepwise dose reduction (DR). Effectiveness (Psoriasis Area and Severity Index, PASI), Dermatology Life Quality Index (DLQI), adverse events, proportion of patients with successful DR and proportion of persistent disease flares were analyzed.
RESULTS


DR leads temporarily to a slightly increased PASI groupwise, but on the long-term patients regained low PASI. DLQI scores remained stable during follow-up. No serious adverse events due to DR were reported. Forty-one percent of patients remained on a low dose up to 2 years. The number of persistent flares was low in DR and UC.
CONCLUSIONS


The proposed dose reduction strategy is effective for a significant part of patients and remains safe up to 2 years of follow-up.",2022,The proposed dose reduction strategy is effective for a significant part of patients and remains safe up to two years of follow-up.,"['psoriasis patients on', 'Psoriasis Patients in Daily Practice', 'patients with a disease flare regained remission']","['usual care (UC) with stepwise dose reduction (DR', 'Biologics Adalimumab, Etanercept, and Ustekinumab', 'adalimumab, etanercept']","['DLQI scores', 'Effectiveness (Psoriasis Area and Severity Index, PASI), Dermatology Life Quality Index (DLQI), adverse events, proportion of patients with successful DR and proportion of persistent disease flares', 'number of persistent flares']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0496508,The proposed dose reduction strategy is effective for a significant part of patients and remains safe up to two years of follow-up.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Atalay', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'J M P A', 'Initials': 'JMPA', 'LastName': 'van den Reek', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'J M M', 'Initials': 'JMM', 'LastName': 'Groenewoud', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'P C M', 'Initials': 'PCM', 'LastName': 'van de Kerkhof', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kievit', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'E M G J', 'Initials': 'EMGJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1869147']
90,33495545,Accelerated brain aging predicts impulsivity and symptom severity in depression.,"Multiple structural and functional neuroimaging measures vary over the course of the lifespan and can be used to predict chronological age. Accelerated brain aging, as quantified by deviations in the MRI-based predicted age with respect to chronological age, is associated with risk for neurodegenerative conditions, bipolar disorder, and mortality. Whether age-related changes in resting-state functional connectivity are accelerated in major depressive disorder (MDD) is unknown, and, if so, it is unclear if these changes contribute to specific cognitive weaknesses that often occur in MDD. Here, we delineated age-related functional connectivity changes in a large sample of normal control subjects and tested whether brain aging is accelerated in MDD. Furthermore, we tested whether accelerated brain aging predicts individual differences in cognitive function. We trained a support vector regression model predicting age using resting-state functional connectivity in 710 healthy adults aged 18-89. We applied this model trained on normal aging subjects to a sample of actively depressed MDD participants (n = 109). The difference between predicted brain age and chronological age was 2.11 years greater (p = 0.015) in MDD patients compared to control participants. An older MDD brain age was significantly associated with increased impulsivity and, in males, increased depressive severity. Unexpectedly, accelerated brain aging was also associated with increased placebo response in a sham-controlled trial of high-frequency repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex. Our results indicate that MDD is associated with accelerated brain aging, and that accelerated aging is selectively associated with greater impulsivity and depression severity.",2021,The difference between predicted brain age and chronological age was 2.11 years greater (p = 0.015) in MDD patients compared to control participants.,"['normal aging subjects to a sample of actively depressed MDD participants (n\u2009=\u2009109', '710 healthy adults aged 18-89']",['support vector regression model predicting age using resting-state functional connectivity'],['depressive severity'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}]",710.0,0.0319125,The difference between predicted brain age and chronological age was 2.11 years greater (p = 0.015) in MDD patients compared to control participants.,"[{'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Dunlop', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA. kad2032@med.cornell.edu.'}, {'ForeName': 'Lindsay W', 'Initials': 'LW', 'LastName': 'Victoria', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Department of Psychiatry and Krembil Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA. fgd2002@med.cornell.edu.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Liston', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA. col2004@med.cornell.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-00967-x']
91,33064621,Teaching pursed-lip breathing through music: MELodica Orchestra for DYspnea (MELODY) trial rationale and protocol.,"BACKGROUND


Patients with chronic obstructive pulmonary disease (COPD) commonly experience dyspnea, which may limit activities of daily living. Pursed-lip breathing improves dyspnea for COPD patients; however, access to pursed-lip breathing training is limited.
METHODS


The proposed MELodica Orchestra for DYspnea (MELODY) study will be a single-site pilot study to assess the safety, feasibility, and efficacy of a music-based approach to teach pursed-lip breathing. Patients with COPD and moderate-severe dyspnea are randomized to intervention, education-control, or usual care control groups. Intervention patients meet twice weekly for eight weeks for melodica instruction, group music-making, and COPD education. Safety, feasibility, and efficacy is assessed qualitatively and quantitatively.
RESULTS


This manuscript describes the rationale and methods of the MELODY pilot project.
CONCLUSIONS


If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.",2022,"If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.","['COPD patients', 'Patients with COPD and moderate-severe dyspnea', 'Patients with chronic obstructive pulmonary disease (COPD']","['music-based approach to teach pursed-lip breathing', 'Pursed-lip breathing']","['dyspnea', 'Safety, feasibility, and efficacy']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.106147,"If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.","[{'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'McGrath', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Rattray', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI), Indianapolis, IN, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Lillie', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI), Indianapolis, IN, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Crow', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI), Indianapolis, IN, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Myers', 'Affiliation': 'Department of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI), Indianapolis, IN, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI), Indianapolis, IN, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wasmuth', 'Affiliation': 'School of Occupational Therapy, Indiana University School of Health & Human Sciences, Indianapolis, IN, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Burns', 'Affiliation': 'Department of Music and Arts Technology, Indiana University-Purdue University Indianapolis (IUPUI), Indianapolis, IN, USA.'}, {'ForeName': 'Ariel J', 'Initials': 'AJ', 'LastName': 'Cheatham', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI), Indianapolis, IN, USA.'}, {'ForeName': 'Himalaya', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'VA HSR&D Center for Health Information and Communication (CHIC), Richard L. Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'Department of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",Arts & health,['10.1080/17533015.2020.1827277']
92,33264825,Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes.,"BACKGROUND


Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, reduced albuminuria in short-term trials involving patients with chronic kidney disease (CKD) and type 2 diabetes. However, its long-term effects on kidney and cardiovascular outcomes are unknown.
METHODS


In this double-blind trial, we randomly assigned 5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive finerenone or placebo. Eligible patients had a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml per minute per 1.73 m 2  of body-surface area, and diabetic retinopathy, or they had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml per minute per 1.73 m 2 . All the patients were treated with renin-angiotensin system blockade that had been adjusted before randomization to the maximum dose on the manufacturer's label that did not cause unacceptable side effects. The primary composite outcome, assessed in a time-to-event analysis, was kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes. The key secondary composite outcome, also assessed in a time-to-event analysis, was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
RESULTS


During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P = 0.001). A key secondary outcome event occurred in 367 patients (13.0%) and 420 patients (14.8%) in the respective groups (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P = 0.03). Overall, the frequency of adverse events was similar in the two groups. The incidence of hyperkalemia-related discontinuation of the trial regimen was higher with finerenone than with placebo (2.3% and 0.9%, respectively).
CONCLUSIONS


In patients with CKD and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo. (Funded by Bayer; FIDELIO-DKD ClinicalTrials.gov number, NCT02540993.).",2020,"During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P = 0.001).","['patients with chronic kidney disease (CKD) and type 2 diabetes', 'Eligible patients had a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml per minute per 1.73 m 2  of body-surface area, and diabetic retinopathy, or they had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml per minute per 1.73 m 2 ', '5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive', 'Type 2 Diabetes']","['placebo', 'renin-angiotensin system blockade', 'finerenone', 'finerenone or placebo', 'Finerenone']","['Chronic Kidney Disease Outcomes', 'time-to-event analysis, was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure', 'frequency of adverse events', 'incidence of hyperkalemia-related discontinuation', 'lower risks of CKD progression and cardiovascular events', 'time-to-event analysis, was kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C4045511', 'cui_str': 'finerenone'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",5734.0,0.692076,"During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P = 0.001).","[{'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kolkhof', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nowack', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schloemer', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2025845']
93,33279855,Androgen deprivation therapy and radiotherapy in intermediate-risk prostate cancer: A randomised phase III trial.,"BACKGROUND


The role of androgen deprivation therapy (ADT) in combination with radiotherapy (RT) in intermediate-risk prostate cancer (IRPC) remains controversial, particularly in patients receiving dose-escalated RT (DERT). We compared outcomes between patients with IRPC treated with ADT and two different doses of RT vs. RT alone.
METHODS


From December 2000 to September 2010, 600 patients with IRPC were randomised to a three-arm trial consisting of 6 months of ADT plus RT 70 Gy (ADT + RT70) vs. ADT plus a DERT of 76 Gy (ADT + DERT76) vs. DERT of 76 Gy alone (DERT76). Primary end-point was biochemical failure (BF), and secondary end-points were overall survival (OS) and toxicity. RT toxicity was assessed by Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer criteria.
FINDINGS


With a median follow-up of 11.3 years (interquartile range: 10.9-11.7), patients receiving DERT76 alone, compared with patients receiving ADT + RT70 and ADT + DERT76, had higher rates of BF (32%, 18% and 14%, respectively, p < 0.001), higher rates of prostate cancer progression (12%, 4.5% and 3.3%, respectively, p = 0.001) and more deaths due to prostate cancer (6.5%, 3.0% and 1.5%, respectively, p = 0.03) with no significant difference seen between ADT + RT70 and ADT + DERT76. There was no significant difference in OS between the 3 arms. A higher dose of RT (76 Gy) increased late gastrointestinal (GI) toxicity grade ≥ II compared with lower dose (70 Gy) (16% vs 5.3%, p < 0.001) with no statistical difference for late genitourinary toxicity.
INTERPRETATION


In IRPC, the addition of 6 months of ADT to RT70 or DERT76 significantly improves BF and appears to decrease the risk of death from prostate cancer compared with DERT76 alone with no difference in OS. In the setting of IRPC, ADT plus RT 70 Gy yields effective disease control with a better GI toxicity profile. Clinicaltrials.gov#NCT00223145.",2021,There was no significant difference in OS between the 3 arms.,"['600 patients with IRPC', 'intermediate-risk prostate cancer (IRPC', 'From December 2000 to September 2010', 'With a median follow-up of 11.3 years', 'patients with IRPC treated with', 'patients receiving dose-escalated RT (DERT', 'intermediate-risk prostate cancer']","['radiotherapy (RT', 'androgen deprivation therapy (ADT', 'Androgen deprivation therapy and radiotherapy', 'ADT plus RT 70\xa0Gy (ADT\xa0+\xa0RT70) vs. ADT plus a DERT of 76\xa0Gy (ADT\xa0+\xa0DERT76) vs. DERT of 76\xa0Gy alone (DERT76', 'RT vs. RT', 'ADT']","['higher rates of prostate cancer progression', 'biochemical failure (BF), and secondary end-points were overall survival (OS) and toxicity', 'OS', 'deaths due to prostate cancer', 'rates of BF', 'RT toxicity', 'late gastrointestinal (GI) toxicity grade\xa0≥\xa0II', 'late genitourinary toxicity', 'risk of death from prostate cancer']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",600.0,0.14783,There was no significant difference in OS between the 3 arms.,"[{'ForeName': 'Abdenour', 'Initials': 'A', 'LastName': 'Nabid', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, CA, Canada. Electronic address: abdenour.nabid@usherbrooke.ca.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Carrier', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, CA, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vigneault', 'Affiliation': 'Centre Hospitalier Universitaire de Québec, CA, Canada.'}, {'ForeName': 'Thu', 'Initials': 'T', 'LastName': 'Van Nguyen', 'Affiliation': 'Centre Hospitalier Universitaire de Montréal, CA, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vavassis', 'Affiliation': 'Hôpital Maisonneuve-Rosemont de Montréal, CA, Canada.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Brassard', 'Affiliation': 'Centre Intégré Universitaire de Santé et de Services Sociaux Du Saguenay-Lac-Saint-Jean, CA, Canada.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Bahoric', 'Affiliation': 'Hôpital Général Juif de Montréal, CA, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Archambault', 'Affiliation': 'Hôpital de Gatineau, CA, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vincent', 'Affiliation': 'Centre Hospitalier Régional de Trois-Rivières, CA, Canada.'}, {'ForeName': 'Redouane', 'Initials': 'R', 'LastName': 'Bettahar', 'Affiliation': 'Centre Hospitalier Régional de Rimouski, CA, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wilke', 'Affiliation': 'Nova Scotia Cancer Center, NS, Canada.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': 'McGill University Health Centre, CA, Canada.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.10.023']
94,33290097,Do cognitive training applications improve executive function in children with adverse childhood experiences? A pilot study.,"Executive function (EF) is comprised of inhibitory control, working memory and cognitive flexibility, core components which more complex skills and abilities develop from, including problem solving, reasoning and planning. Adverse childhood experiences (ACE) negatively impact the development of these skills and in turn life outcomes. This pilot-study explores the use of computerized cognitive training applications (CCTA) (software-based training programs) in school, to improve these skills in children aged 6-11 with ACE. A pre-post-test, between-subject experimental design using an experimental and a placebo-control group was used. The control group were matched to the experimental group by prior academic attainment level and age. A one-way multivariate analysis of covariance (MANCOVA) assessed changes in EF across two time-points between the experimental and the control group. Both groups of participants were selected based on an ACE parent-report questionnaire score of 4+ ( n  = 32). EF was measured using the Behavior Rating Inventory of Executive Function (BRIEF), assessing far-transfer of training to behavioral measures of EF. Results show CCTA had a significant positive impact on executive function, particularly on working memory. This small-scale pilot study presents exciting directions for future research into the role of CCTA in order to confirm conclusions drawn.",2022,"Results show CCTA had a significant positive impact on executive function, particularly on working memory.","['children with adverse childhood experiences', 'children aged 6-11 with ACE', 'Both groups of participants were selected based on an ACE parent-report questionnaire score of 4+ ( n \u2009=\u200932']","['placebo-control', 'CCTA', 'cognitive training applications', 'Executive function (EF', 'computerized cognitive training applications (CCTA) (software-based training programs']","['EF', 'working memory', 'Behavior Rating Inventory of Executive Function (BRIEF), assessing far-transfer of training to behavioral measures of EF', 'executive function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.016351,"Results show CCTA had a significant positive impact on executive function, particularly on working memory.","[{'ForeName': 'John Henry', 'Initials': 'JH', 'LastName': 'Spawton-Rice', 'Affiliation': 'Psychology and Human Development, University College London Institute of Education, London, United Kingdom.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Walker', 'Affiliation': 'Psychology and Human Development, University College London Institute of Education, London, United Kingdom.'}]",Applied neuropsychology. Child,['10.1080/21622965.2020.1854094']
95,33349043,Impact of placebo-related instruction on HEG biofeedback outcomes in children with ADHD.,Studies to date have not revealed any differences between biofeedback (BFB) methods vs. placebo treatment in reducing ADHD symptoms. The purpose of this randomized controlled study was to assess the impact of placebo expectations on gain in hemoencephalographic (HEG) BFB. The final cohort consisted of 33 children with ADHD aged 9-14. Individuals were assigned to one of two groups (with standard active training instruction vs. placebo-related instruction) and were subjected to five HEG BFB sessions. Children with standard instruction exhibited higher growth of regional cerebral blood oxygenation during the HEG BFB session as well as better results in cognitive tests (vigilance and visual search) at the end of the experiment compared to children with placebo-related instruction. The data obtained indicate the difficulty in designing studies assessing BFB efficacy. Placebo expectation may adversely affect HEG BFB outcomes in children with ADHD.,2022,Children with standard instruction exhibited higher growth of regional cerebral blood oxygenation during the HEG BFB session as well as better results in cognitive tests (vigilance and visual search) at the end of the experiment compared to children with placebo-related instruction.,"['children with ADHD', '33 children with ADHD aged 9-14']","['Placebo', 'standard active training instruction vs. placebo-related instruction) and were subjected to five HEG BFB sessions', 'placebo-related instruction', 'placebo']","['cognitive tests (vigilance and visual search', 'HEG BFB outcomes', 'gain in hemoencephalographic (HEG) BFB', 'BFB efficacy', 'HEG biofeedback outcomes', 'growth of regional cerebral blood oxygenation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",33.0,0.192763,Children with standard instruction exhibited higher growth of regional cerebral blood oxygenation during the HEG BFB session as well as better results in cognitive tests (vigilance and visual search) at the end of the experiment compared to children with placebo-related instruction.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Skalski', 'Affiliation': 'Polish Academy of Sciences, Institute of Psychology, Warsaw, Poland.'}]",Applied neuropsychology. Child,['10.1080/21622965.2020.1861546']
96,33541815,The efficacy of olive leaf extract on healing herpes simplex virus labialis: A randomized double-blind study.,"OBJECTIVE


Herpes simplex virus (HSV), as a common infection in healthy individuals, is treated symptomatically, but drug resistance and the side effects of drugs have drawn the attention of researchers to complementary medicine. Olive Leaf Extract (OLE) has antiviral effects that may treat HSV. The current study aimed to compare the clinical effects of OLE and Acyclovir on HSV-1.
METHODS


This randomized double-blind clinical trial was conducted on 66 patients who had already been diagnosed with HSV-1. The participants were randomized into two groups, receiving 2% OLE cream or 5% acyclovir cream five times a day for six days. The symptoms were evaluated before, and three and six days after the interventions. Data were analyzed using the SPSS software through the Kolmogorov-Smirnov test, chi-squared, t-test, and repeated measures ANOVA.
RESULTS


The results showed clinical symptoms decreased in both groups during the study and both medications were effective in the treatment of HSV-1. However, the OLE group experienced less bleeding (P = 0.038), itching (P = 0.002), and pain (P = 0.001) on the third day as well as less irritation (P = 0.012), itching (P = 0.003) and color change (P = 0.001) on the sixth day compared to the acyclovir group. The treatment course for participants in the OLE group was shorter than in the acyclovir group (P = 0.001).
CONCLUSION


The evidence from these trials suggests the OLE cream is superior in the healing of episodes of HSV-1 over the acyclovir cream. Future studies are recommended to investigate if OLE could be an adjunct to acyclovir treatment.",2022,"However, the OLE group experienced less bleeding (P = 0.038), itching (P = 0.002), and pain (P = 0.001) on the third day as well as less irritation (P = 0.012), itching (P = 0.003) and color change (P = 0.001) on the sixth day compared to the acyclovir group.","['healing herpes simplex virus labialis', 'healthy individuals', '66 patients who had already been diagnosed with HSV-1']","['olive leaf extract', 'Olive Leaf Extract (OLE', 'acyclovir', 'OLE cream', 'OLE', 'OLE and Acyclovir', 'receiving 2% OLE cream or 5% acyclovir cream']","['color change', 'bleeding', 'irritation', 'itching', 'clinical symptoms', 'pain']","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1364955', 'cui_str': 'Olive Leaf Extract'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C1251800', 'cui_str': 'Acyclovir Topical Cream'}]","[{'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",66.0,0.187956,"However, the OLE group experienced less bleeding (P = 0.038), itching (P = 0.002), and pain (P = 0.001) on the third day as well as less irritation (P = 0.012), itching (P = 0.003) and color change (P = 0.001) on the sixth day compared to the acyclovir group.","[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Toulabi', 'Affiliation': 'Razi Herbal Medicines Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran; School of Nursing & Midwifery, Lorestan University of Medical Sciences, Khorramabad, Iran. Electronic address: Tolabi.t@lums.ac.ir.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Delfan', 'Affiliation': 'Razi Herbal Medicines Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran; School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran. Electronic address: Delfanb@yahoo.com.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Rashidipour', 'Affiliation': 'Razi Herbal Medicines Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran. Electronic address: m.rashidipour@lums.ac.ir.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Yarahmadi', 'Affiliation': 'School of Nursing & Midwifery, Lorestan University of Medical Sciences, Khorramabad, Iran; Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: S.Yarahmadi000@gmail.com.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ravanshad', 'Affiliation': 'School of Nursing & Midwifery, Lorestan University of Medical Sciences, Khorramabad, Iran. Electronic address: fr.ravanshad@gmail.com.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Javanbakht', 'Affiliation': 'Lorestan University of Medical Sciences, Khorramabad, Iran. Electronic address: javanbakht7@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Almasian', 'Affiliation': 'School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran. Electronic address: almasian@yahoo.com.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.01.003']
97,33541218,Intraosseous vascular access using the EZ-IO can be safely maintained in the adult proximal humerus and proximal tibia for up to 48 h: Report of a clinical study.,"BACKGROUND


Historically, intraosseous (IO) vascular access devices cleared to market by the US FDA have been restricted to 24-h use. An observational study was conducted to determine the safety of IO access for a period up to 48 h in adult volunteers.
METHODS


A 2-arm randomized, stratified, parallel assignment, prospective interventional study was conducted at ICON Early Phase Services in San Antonio, Texas, United States. Study subjects were adult volunteers who were healthy or with a history of mild to moderate renal disease and/or controlled diabetes. Subjects were randomized to receive IO access (Arrow EZ-IO Vascular Access System, Teleflex Medical Incorporated, Morrisville, NC, USA) in the proximal humerus or the proximal tibia and maintain the indwelling catheter for 48 h. Subjects were monitored for the entire dwell time. A culture specimen was drawn from the indwelling catheter tip before removal and insertion site x-rays were taken.
RESULTS


121 subjects were randomized: 79 healthy, 39 with diabetes, and three with diabetes and renal insufficiency. The mean catheter dwell time was 48.0 ± 0.2 h. Overall first attempt success rate was 98.4%. Infusion pain was the most commonly reported adverse event. There were no serious complications or unanticipated adverse events.
CONCLUSIONS


This is the first known study examining the safety of IO access over a 48-h dwell time. The study corroborates the literature findings, demonstrates device safety, and provides evidence supporting the extended indication for a dwell time to 48 h in adult patients. IO placement and infusion best practices/guidelines were confirmed or established.",2022,"There were no serious complications or unanticipated adverse events.
","['121 subjects were randomized: 79 healthy, 39 with diabetes, and three with diabetes and renal insufficiency', 'adult volunteers', 'ICON Early Phase Services in San Antonio, Texas, United States', 'Study subjects were adult volunteers who were healthy or with a history of mild to moderate renal disease and/or controlled diabetes']","['IO access (Arrow EZ-IO Vascular Access System, Teleflex Medical Incorporated, Morrisville, NC, USA']","['serious complications or unanticipated adverse events', 'Infusion pain', 'mean catheter dwell time', 'safety of IO access']","[{'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0243020', 'cui_str': 'Immunoconjugate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0595613', 'cui_str': 'Intraosseous route'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0336721', 'cui_str': 'Arrow'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0595613', 'cui_str': 'Intraosseous route'}, {'cui': 'C0444454', 'cui_str': 'Access'}]",121.0,0.0713382,"There were no serious complications or unanticipated adverse events.
","[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Philbeck', 'Affiliation': 'Department of Clinical and Medical Affairs, Teleflex Medical Incorporated, San Antonio, TX, USA.'}, {'ForeName': 'Tatiana A', 'Initials': 'TA', 'LastName': 'Puga', 'Affiliation': 'Department of Clinical and Medical Affairs, Teleflex Medical Incorporated, San Antonio, TX, USA.'}, {'ForeName': 'Diana F', 'Initials': 'DF', 'LastName': 'Montez', 'Affiliation': 'Department of Clinical and Medical Affairs, Teleflex Medical Incorporated, San Antonio, TX, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Davlantes', 'Affiliation': 'Department of Clinical and Medical Affairs, Teleflex Medical Incorporated, San Antonio, TX, USA.'}, {'ForeName': 'Emanuel P', 'Initials': 'EP', 'LastName': 'DeNoia', 'Affiliation': 'Department of Clinical Operations, ICON Early Phase Services, San Antonio, TX, USA.'}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Miller', 'Affiliation': 'Department of Clinical Operations, ICON Early Phase Services, San Antonio, TX, USA.'}]",The journal of vascular access,['10.1177/1129729821992667']
98,33541690,Visual teaching aids improve patient understanding and reduce anxiety prior to a colectomy.,"BACKGROUND


Informed consent forms consist of large blocks of written information that may be difficult for patients to understand. Visual teaching aids are promising, however, they have not been studied as a pre-operative educational tool for common surgical procedures. We pilot tested the use of a visual teaching aid during the informed consent process for a colectomy.
METHODS


A randomized pilot study was performed. Participants were randomized into the visual teaching aid group or standard care. Following the consent process, participants were questioned about potential surgical complications, anxiety, satisfaction, and understanding.
RESULTS


30 participants were enrolled. Potential complication recall and patient-reported understanding were improved in the visual group (p = 0.01, p = 0.03). Anxiety levels were reduced in the visual group (p = 0.02). No statistically significant data were found for satisfaction (p = 0.75).
CONCLUSIONS


Utilizing a visual teaching aid during the consent process for colectomy increases patient recall of risks, reduces anxiety, and improves understanding.",2021,"Potential complication recall and patient-reported understanding were improved in the visual group (p = 0.01, p = 0.03).",['30 participants were enrolled'],"['visual teaching aid group or standard care', 'visual teaching', 'Visual teaching aids']",['Anxiety levels'],[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",30.0,0.0363535,"Potential complication recall and patient-reported understanding were improved in the visual group (p = 0.01, p = 0.03).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Stewart', 'Affiliation': 'School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jameson', 'Initials': 'J', 'LastName': 'Wiener', 'Affiliation': 'School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Kennedy', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Chu', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Lancaster', 'Affiliation': 'School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Morris', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: msmorris@uabmc.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2021.01.029']
99,33560877,"Primary Tumor Resection Plus Chemotherapy Versus Chemotherapy Alone for Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastases (JCOG1007; iPACS): A Randomized Clinical Trial.","PURPOSE


It remains controversial whether primary tumor resection (PTR) before chemotherapy improves survival in patients with colorectal cancer (CRC) with asymptomatic primary tumor and synchronous unresectable metastases.
PATIENTS AND METHODS


This randomized phase III study investigated the superiority of PTR followed by chemotherapy versus chemotherapy alone in relation to overall survival (OS) in patients with unresectable stage IV asymptomatic CRC and three or fewer unresectable metastatic diseases confined to the liver, lungs, distant lymph nodes, or peritoneum. Chemotherapy regimens of either mFOLFOX6 plus bevacizumab or CapeOX plus bevacizumab were decided before study entry. The primary end point was OS, which was analyzed by intention-to-treat.
RESULTS


Between June 2012 and September 2019, a total of 165 patients were randomly assigned to either chemotherapy alone (84 patients) or PTR plus chemotherapy (81 patients). When the first interim analysis was performed in September 2019 with 50% (114/227) of the expected events observed among 160 patients at the data cutoff date of June 5, 2019, the Data and Safety Monitoring Committee recommended early termination of the trial because of futility. With a median follow-up of 22.0 months, median OS was 25.9 months (95% CI, 19.9 to 31.5) in the PTR plus chemotherapy arm and 26.7 (95% CI, 21.9 to 32.5) in the chemotherapy-alone arm (hazard ratio, 1.10; 95% CI, 0.76 to 1.59; one-sided  P  = .69). Three postoperative deaths occurred in the PTR plus chemotherapy arm.
CONCLUSION


Given that PTR followed by chemotherapy showed no survival benefit over chemotherapy alone, PTR should no longer be considered a standard of care for patients with CRC with asymptomatic primary tumors and synchronous unresectable metastases.",2021,"With a median follow-up of 22.0 months, median OS was 25.9 months (95% CI, 19.9 to 31.5) in the PTR plus chemotherapy arm and 26.7 (95% CI, 21.9 to 32.5) in the chemotherapy-alone arm (hazard ratio, 1.10; 95% CI, 0.76 to 1.59; one-sided  P  = .69).","['patients with colorectal cancer (CRC) with asymptomatic primary tumor and synchronous unresectable metastases', 'patients with unresectable stage IV asymptomatic CRC and three or fewer unresectable metastatic diseases confined to the liver, lungs, distant lymph nodes, or peritoneum', 'patients with CRC with asymptomatic primary tumors and synchronous unresectable metastases', 'Colorectal Cancer Patients', 'Between June 2012 and September 2019, a total of 165 patients']","['mFOLFOX6 plus bevacizumab or CapeOX plus bevacizumab', 'chemotherapy versus chemotherapy', 'PTR plus chemotherapy', 'chemotherapy alone', 'PTR', 'Primary Tumor Resection Plus Chemotherapy Versus Chemotherapy']","['survival', 'overall survival (OS', 'median OS', 'survival benefit', 'postoperative deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319555', 'cui_str': '165'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0277599', 'cui_str': 'Postoperative death'}]",165.0,0.184558,"With a median follow-up of 22.0 months, median OS was 25.9 months (95% CI, 19.9 to 31.5) in the PTR plus chemotherapy arm and 26.7 (95% CI, 21.9 to 32.5) in the chemotherapy-alone arm (hazard ratio, 1.10; 95% CI, 0.76 to 1.59; one-sided  P  = .69).","[{'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': 'Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Shida', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Komori', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ojima', 'Affiliation': 'Gunma Prefectural Cancer Center, Ota, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ike', 'Affiliation': 'Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Shiomi', 'Affiliation': 'Shizuoka Cancer Center Hospital, Shizuoka, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Takii', 'Affiliation': 'Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Katsumata', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Okuda', 'Affiliation': 'Osaka Medical College Hospital, Osaka, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Hyakudomi', 'Affiliation': 'Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Kochi Health Sciences Center, Kochi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02447']
100,33719775,Toward safer opioid prescribing: effects of the TOWER intervention on HIV care providers.,"ABSTRACT Rates of opioid use disorder and associated deaths remain alarmingly high. Measures to address the epidemic have included reductions in opioid prescribing, in part guided by the Centers for Disease Control Opioid Prescribing Guideline (CDCG). While reductions in over-prescribing have occurred, these measures have also resulted in decreased access and adverse outcomes for some stable opioid-treated chronic pain patients. The TOWard SafER Opioid Prescribing (TOWER) intervention was designed to support HIV primary care providers in use of the CDCG and in decision-making and patient-provider communication regarding safe opioid prescribing. Eleven HIV primary care providers and 40 of their patients were randomized into intervention and control groups. Transcripts from 21 patient visits were analyzed, focusing on opioid and pain-related communications. Findings from this research indicate greater alignment with the CDCG among visits carried out with providers in the TOWER intervention group. However, control group visits were notably consistent with guideline recommendations in several key areas. Differences observed between the intervention and control group visits demonstrate intervention strengths, as well as areas where additional work needs to be done to ensure prescribing and communication consistent with the CDCG.",2022,"While reductions in over-prescribing have occurred, these measures have also resulted in decreased access and adverse outcomes for some stable opioid-treated chronic pain patients.","['Eleven HIV primary care providers and 40 of their patients', 'HIV care providers']",['TOWER intervention'],[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],11.0,0.036302,"While reductions in over-prescribing have occurred, these measures have also resulted in decreased access and adverse outcomes for some stable opioid-treated chronic pain patients.","[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Center for Evaluation and Applied Research, The New York Academy of Medicine, New York, NY, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kamler', 'Affiliation': 'Center for Evaluation and Applied Research, The New York Academy of Medicine, New York, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Weiss', 'Affiliation': 'Center for Evaluation and Applied Research, The New York Academy of Medicine, New York, NY, USA.'}, {'ForeName': 'Mary-Catherine', 'Initials': 'MC', 'LastName': 'George', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Cedillo', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Cárdenas', 'Affiliation': 'Center for Evaluation and Applied Research, The New York Academy of Medicine, New York, NY, USA.'}, {'ForeName': 'Sheaba', 'Initials': 'S', 'LastName': 'Daniel', 'Affiliation': 'Center for Evaluation and Applied Research, The New York Academy of Medicine, New York, NY, USA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'DeGarmo', 'Affiliation': 'Center for Evaluation and Applied Research, The New York Academy of Medicine, New York, NY, USA.'}, {'ForeName': 'Yaowaree', 'Initials': 'Y', 'LastName': 'Leavell', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Center for Evaluation and Applied Research, The New York Academy of Medicine, New York, NY, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Robinson-Papp', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",AIDS care,['10.1080/09540121.2021.1887444']
101,33619983,Peripheral intravenous cannulae in neonates: To splint or not?,"OBJECTIVE


To determine the effect of splint on the dwell time of peripheral intravenous cannula in neonates.
SETTING


Level II Neonatal Intensive Care Unit (NICU).
PATIENTS


Consecutive babies with presumed need of peripheral intravenous access of at least 24 h.
METHODS


Enrolled subjects were randomized to ""splint"" or ""splint-less"" group. Insertion site was cleaned with Isopropyl alcohol and 2% Chlorhexidine and peripheral intravenous catheter was inserted under strict asepsis. Insertion sites was examined regularly for occurrence of complication which necessitated removal of the catheter.
RESULTS


Out of 159 neonates, 80 were allotted to splint group and the rest to splint-less group. Mean dwell time of intravenous line in splint group was 27.68 ± 13.03 h which was significantly less than in splint-less group (32.87 ± 15.79 h, mean difference: 5.11 h,  p  value: 0.03). Subgroup analysis in preterms showed mean dwell time of 28.54 ± 14.86 h in splint group which was less than that of splint-less group (35.10 ± 16.24 h) ( p  value: 0.03). No such difference was noted in the term neonates. Subgroup analysis for catheters put across joints does not show difference in mean dwell times between splint and splint-less groups. Multivariate regression analysis did not identify any variable which independently affected the outcome.
CONCLUSION


Use of splint does not prolong the dwell time of the catheter and is probably harmful in some neonates.",2022,Subgroup analysis for catheters put across joints does not show difference in mean dwell times between splint and splint-less groups.,"['159 neonates', 'Level II Neonatal Intensive Care Unit (NICU', 'neonates', 'Consecutive babies with presumed need of peripheral intravenous access of at least 24\u2009h.\nMETHODS\n\n\nEnrolled subjects']","['splint"" or ""splint-less"" group', 'Isopropyl alcohol and 2% Chlorhexidine']","['mean dwell time', 'Mean dwell time of intravenous line']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0441926', 'cui_str': 'Level II'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",159.0,0.0543314,Subgroup analysis for catheters put across joints does not show difference in mean dwell times between splint and splint-less groups.,"[{'ForeName': 'Tiroumourougane', 'Initials': 'T', 'LastName': 'Serane V', 'Affiliation': ""Canvij Neonatal Services, A.G. Padmavati's Hospital, Arumparthapuram, Pondicherry, India.""}, {'ForeName': 'Rathnapratheep', 'Initials': 'R', 'LastName': 'Rajasekaran', 'Affiliation': 'Department of Pediatrics, Sri Venkateswara Medical College, Ariyur, Pondicherry, India.'}, {'ForeName': 'Vijayasankar', 'Initials': 'V', 'LastName': 'Vijayadevagaran', 'Affiliation': ""Canvij Neonatal Services, A.G. Padmavati's Hospital, Arumparthapuram, Pondicherry, India.""}, {'ForeName': 'Bhuvaneswari', 'Initials': 'B', 'LastName': 'Kothendaraman', 'Affiliation': 'Department of Medicine, Indira Gandhi Medical College and Research Institute, Kathirkamam, Pondicherry, India.'}]",The journal of vascular access,['10.1177/1129729821996926']
102,33625064,Genetic Associations with Weight Gain among South Africans who Initiated Dolutegravir-Containing and Tenofovir-Containing Regimens.,"BACKGROUND


Excessive weight gain affects some HIV-positive individuals prescribed dolutegravir-containing regimens. Mechanisms underlying such weight gain are unknown.
SETTING


Data and DNA from antiretroviral therapy-naïve participants who were randomized to initiate dolutegravir with emtricitabine plus either tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) in the ADVANCE study (NCT03122262) were used to characterize associations between human genetic polymorphisms and magnitude of weight gain.
METHODS


Associations with percent weight gain from baseline to week 48 were assessed using multivariable linear regression models. Primary analyses a priori considered 59 polymorphisms and 10 genes of potential relevance to dolutegravir, TAF, or TDF pharmacokinetics. We also explored genome-wide associations.
RESULTS


Among the 314 (92%) of 340 dolutegravir recipients who were successfully genotyped, 160 (47%) and 154 (45%) were randomized to TAF/emtricitabine and TDF/emtricitabine, respectively. In target gene analyses, the lowest P-values for the dolutegravir and tenofovir groups were ABCG2 rs4148149 (P = 7.0 × 10-4) and ABCC10 rs67861980 (P = 1.0 × 10-2), respectively, which were not significant after correction for multiple testing. In genome-wide analyses, the lowest P-values were rs7590091 in TMEM163 (P = 3.7 × 10-8) for dolutegravir, rs17137701 in LOC105379130 (P = 6.4 × 10-8) for TAF, and rs76771105 in LOC105371716 (P = 9.7 × 10-8) for TDF.
CONCLUSIONS


Among South African participants in a randomized clinical trial of dolutegravir plus either TAF/emtricitabine or TDF/emtricitabine, we identified several potential genetic associations with weight gain. Only TMEM163 rs7590091 withstood correction for multiple testing. These associations warrant replication in other cohorts.",2021,"In genome-wide analyses the lowest P-values for dolutegravir, was rs7590091 in TMEM163 (P = 3.7x10-8), rs17137701 in LOC105379130","['South Africans who Initiated Dolutegravir- and Tenofovir-containing Regimens', 'Among the 314 (92%) of 340 dolutegravir recipients who were successfully genotyped, 160 (47%) and 154 (45%) were randomized to', 'South African participants', 'Data and DNA from antiretroviral therapy-naïve participants who were randomized to initiate dolutegravir with']","['TAF/emtricitabine and TDF/emtricitabine', 'emtricitabine plus either tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF', 'TAF/emtricitabine or TDF/emtricitabine']","['weight gain', 'potential relevance to dolutegravir, TAF or TDF pharmacokinetics']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0941906,"In genome-wide analyses the lowest P-values for dolutegravir, was rs7590091 in TMEM163 (P = 3.7x10-8), rs17137701 in LOC105379130","[{'ForeName': 'Zinhle', 'Initials': 'Z', 'LastName': 'Cindi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Bradford', 'Affiliation': 'Department of Genetics, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Willem D F', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Simiso', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nomathemba C', 'Initials': 'NC', 'LastName': 'Chandiwana', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Haas', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; and.'}, {'ForeName': 'Phumla', 'Initials': 'P', 'LastName': 'Sinxadi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002661']
103,33605177,Computerized inhibitory control training reduces anxiety in preadolescent students.,"The study examined the relationship between anxiety, inhibitory control (IC), and resting-state electroencephalography (EEG) in a critical age-range for social and emotional development (8-12-year-olds). The participants were assigned to 4 weeks of either an emotional IC training program, a neutral IC training program, or a waitlisted control, and were tested using cognitive, emotional, and EEG measures. The training was computerized and completed remotely. At baseline, IC accuracy scores were negatively related to both anxiety and depression levels ( N  = 42). Additionally, increased right lateral frontal alpha asymmetry was predictive of increased anxiety/depression scores. A series of multivariate analyses of covariance and post-hoc tests were conducted to compare effects in the participants that completed the full 16 sessions of training ( N  = 32). Overall the emotional and neutral training conditions showed similar improvements in IC accuracy, as well as reductions in anxiety compared to the waitlist condition. Minimal neurophysiological changes occurred from pre-to-post; however, lateral frontal asymmetry shifted leftward in the emotional training group. These findings highlight the potential of computerized IC training for mitigating negative emotional functioning in preadolescents. Future research is necessary to determine the long-term effects of IC training and whether longer training intervals facilitate persisting impacts.",2022,"Overall the emotional and neutral training conditions showed similar improvements in IC accuracy, as well as reductions in anxiety compared to the waitlist condition.","['a critical age-range for social and emotional development (8-12-year-olds', 'preadolescent students']","['emotional IC training program, a neutral IC training program, or a waitlisted control, and were tested using cognitive, emotional, and EEG measures', 'computerized IC training', 'Computerized inhibitory control training']","['IC accuracy scores', 'anxiety', 'Minimal neurophysiological changes', 'anxiety, inhibitory control (IC), and resting-state electroencephalography (EEG', 'anxiety and depression levels', 'right lateral frontal alpha asymmetry', 'IC accuracy', 'anxiety/depression scores']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0450415', 'cui_str': 'Lateral to the right'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0164917,"Overall the emotional and neutral training conditions showed similar improvements in IC accuracy, as well as reductions in anxiety compared to the waitlist condition.","[{'ForeName': 'Nathaniel A', 'Initials': 'NA', 'LastName': 'Shanok', 'Affiliation': 'Behavioral Sciences Department, Florida Atlantic University, Boca Raton, Florida, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Meltzer', 'Affiliation': 'Behavioral Sciences Department, Florida Atlantic University, Boca Raton, Florida, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Frank', 'Affiliation': 'Behavioral Sciences Department, Florida Atlantic University, Boca Raton, Florida, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Lugo', 'Affiliation': 'Behavioral Sciences Department, Florida Atlantic University, Boca Raton, Florida, USA.'}, {'ForeName': 'Nancy Aaron', 'Initials': 'NA', 'LastName': 'Jones', 'Affiliation': 'Behavioral Sciences Department, Florida Atlantic University, Boca Raton, Florida, USA.'}]",Applied neuropsychology. Child,['10.1080/21622965.2021.1884984']
104,33678106,Clinical implications and predictive values of early PASI responses to tildrakizumab in patients with moderate-to-severe plaque psoriasis.,"OBJECTIVE


To evaluate whether early Psoriasis Area Severity Index (PASI) improvements can predict week 28 tildrakizumab responders and nonresponders.
METHODS


Psoriasis patients pooled from two tildrakizumab phase 3 trials randomized to receive tildrakizumab 100 mg at weeks 0, 4, 16, and 28 were included. Patients were grouped by week 28 PASI responses (<50, 50-74, 75-89, and 90-100). PASI improvements from baseline at weeks 4 and 16 were analyzed for each response group.
RESULTS


Of 575 patients included, 8.3%, 14.3%, 23.8%, and 53.6%, respectively, achieved PASI <50, 50-74, 75-89, and 90-100 at week 28. Of patients with PASI <50 at week 16, 85% did not achieve PASI ≥75 at week 28 (nonresponders). Rapid response, defined as PASI ≥50 at week 4 (after a single tildrakizumab dose), was observed in 41% of patients. Of these patients, 87% were week 28 responders (PASI ≥75); 67% were 'super responders' (PASI 90-100). Among week 28 responders and super responders, 45% and 50% achieved PASI ≥50 at week 4, respectively.
CONCLUSIONS


Tildrakizumab week 28 nonresponders can be identified by week 16 PASI response. PASI improvements as early as week 4 can predict patients' week 28 PASI improvement status.",2022,"Among week 28 responders and super responders, 45% and 50% achieved PASI ≥50 at week 4, respectively.",['Patients with Moderate-to-Severe Plaque Psoriasis'],"['Tildrakizumab', 'tildrakizumab']",['early Psoriasis Area Severity Index (PASI'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}]",575.0,0.0342319,"Among week 28 responders and super responders, 45% and 50% achieved PASI ≥50 at week 4, respectively.","[{'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pariser', 'Affiliation': 'Eastern Virginia Medical School, Virginia Clinical Research, Inc, Norfolk, VA, USA.'}, {'ForeName': 'Jingchuan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Sun Pharmaceutical Industries Inc., Princeton, NJ, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Sun Pharmaceutical Industries Inc., Princeton, NJ, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Mendelsohn', 'Affiliation': 'Sun Pharmaceutical Industries Inc., Princeton, NJ, USA.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2021.1898528']
105,33715537,Mobile-health intervention for smoking cessation among Cambodian people living with HIV: A mixed-methods pilot study.,"This mixed methods study aimed to evaluate the feasibility and preliminary efficacy of a fully automated, interactive smartphone-delivered intervention for smoking cessation among people living with HIV in Cambodia. We used the explanatory sequential design, with a pilot two-group single-blind randomized controlled trial ( N  = 50) followed by in-depth interviews with all trial participants. In the trial, participants were randomized to Standard Care (SC) or Automated Messaging (AM) group. SC comprised brief advice to quit and self-help materials. AM consisted of the SC components plus a fully automated smartphone-based treatment program that involved interactive and tailored proactive messaging for 2 months. Results showed that the AM approach was highly feasible and efficacious. Feasibility was supported by high rates of treatment engagement (e.g., 81% of delivered messages and assessments were read or completed) and high retention (96%) through the 2-month follow-up. Biochemically verified point prevalence abstinence at follow-up was 40% for the AM group and 8% for the SC group (relative risk: 5.0, 95% confidence interval: 1.2, 20.5). Being able to avoid other smokers, having coping skills, and having social/familial support contributed to successful abstinence. The AM program has the potential for wide-scale implementation in Cambodia and other low-income countries.",2022,"Biochemically verified point prevalence abstinence at follow-up was 40% for the AM group and 8% for the SC group (relative risk: 5.0, 95% confidence interval: 1.2, 20.5).","['people living with HIV in Cambodia', 'Cambodian people living with HIV']","['Standard Care (SC) or Automated Messaging (AM', 'Mobile-health intervention', 'fully automated, interactive smartphone-delivered intervention']",['prevalence abstinence'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}, {'cui': 'C1553323', 'cui_str': 'Cambodians'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.105642,"Biochemically verified point prevalence abstinence at follow-up was 40% for the AM group and 8% for the SC group (relative risk: 5.0, 95% confidence interval: 1.2, 20.5).","[{'ForeName': 'Thanh Cong', 'Initials': 'TC', 'LastName': 'Bui', 'Affiliation': 'Department of Family and Preventive Medicine, College of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Sopheab', 'Affiliation': 'School of Public Health, National Institute of Public Health of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Businelle', 'Affiliation': 'Department of Family and Preventive Medicine, College of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Chhorvann', 'Initials': 'C', 'LastName': 'Chhea', 'Affiliation': 'School of Public Health, National Institute of Public Health of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Sun Penh', 'Initials': 'SP', 'LastName': 'Ly', 'Affiliation': 'National Center for HIV/AIDS, Dermatology and STD of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Jennifer I', 'Initials': 'JI', 'LastName': 'Vidrine', 'Affiliation': 'Moffitt Cancer Center, Department of Health Outcomes and Behavior, Tampa, FL, USA.'}, {'ForeName': 'Dawin', 'Initials': 'D', 'LastName': 'Thol', 'Affiliation': 'Preventive Medicine Department, Ministry of Health of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Frank-Pearce', 'Affiliation': 'TSET Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Damon J', 'Initials': 'DJ', 'LastName': 'Vidrine', 'Affiliation': 'Moffitt Cancer Center, Department of Health Outcomes and Behavior, Tampa, FL, USA.'}]",AIDS care,['10.1080/09540121.2021.1887443']
106,33646918,Experimentally-manipulated perceptions of good sleep predict greater reactivity to and poorer recovery from a social stressor in university students.,"OBJECTIVE


The present study was conducted to examine the impact of experimentally-manipulated perceptions of sleep on self-reported affective reactivity and recovery from a social stressor in undergraduate students.
DESIGN


The study design is experimental, as the participants were randomly assigned to either good or poor perceived sleep quality conditions.
MAIN OUTCOME MEASURES


The impact of condition on self-reported affective responses to and recovery from the social stressor were assessed as well as whether the observed effects were moderated by stress, rumination, and depression.
RESULTS


Participants in the good sleep condition reported increased negative affect (NA) after the social stressor and after a six-minute recovery period relative to participants in the poor sleep condition; participants in the former condition also reported heightened NA post-recovery relative to baseline (a comparison that was non-significant for participants in the poor sleep condition). The effect of condition on NA post-stressor and post-recovery was moderated by depression and rumination, with important implications for participants in the good sleep condition in particular.
CONCLUSIONS


These findings may have resulted from participant expectations about the impacts of sleep on their behaviour, although additional research remains to be conducted to identify the mechanism responsible for the obtained pattern of results.",2022,"The effect of condition on NA post-stressor and post-recovery was moderated by depression and rumination, with important implications for participants in the good sleep condition in particular.
","['participants in the good sleep condition in particular', 'undergraduate students', 'university students']",[],[],"[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],[],,0.0195431,"The effect of condition on NA post-stressor and post-recovery was moderated by depression and rumination, with important implications for participants in the good sleep condition in particular.
","[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Tsukerman', 'Affiliation': 'Department of Psychological Science, UC Irvine, Irvine, CA, USA.'}, {'ForeName': 'Angela F', 'Initials': 'AF', 'LastName': 'Lukowski', 'Affiliation': 'Department of Psychological Science, UC Irvine, Irvine, CA, USA.'}]",Psychology & health,['10.1080/08870446.2021.1890728']
107,33664429,Vitamin K2 (menaquinone-7) increases plasma adiponectin but does not affect insulin sensitivity in postmenopausal women: a randomized controlled trial.,"BACKGROUND/OBJECTIVES


Vitamin K is a co-factor in the carboxylation of the bone matrix protein osteocalcin (OC), and thus decreases the concentration of undercarboxylated osteocalcin (ucOC). Animal and in vitro studies suggest that ucOC increases insulin sensitivity. However, epidemiological studies find positive associations between vitamin K intake and insulin sensitivity. We aimed to investigate the effect of vitamin K2 in the form of menaquinone-7 (MK-7) on serum ucOC, bone mass, and insulin sensitivity in postmenopausal women.
SUBJECTS/METHODS


This was a randomized placebo-controlled trial. One hundred forty-eight postmenopausal women received MK-7 375 µg daily or placebo, as an add-on to calcium (800 mg) and vitamin D (38 µg) for 12 months. We measured serum ucOC, insulin sensitivity by HOMA-IR, and plasma adiponectin and leptin at baseline and after 12 months.
RESULTS


S-ucOC decreased in the MK-7 group (-70.3 (-75.6; -63.8) %) compared to the placebo group (-7.2 (-15.9; 2.0) %) after 12 months (p < 0.01). P-adiponectin increased in the MK-7 group (6.1 ± 20.1%) (mean ± SD) compared to the placebo group (-0.7 ± 15.5%) after 12 months (p = 0.03). HOMA-IR and p-leptin did not change in the two groups.
CONCLUSION


Treatment with MK-7 for 12 months decreased p-ucOC, increased p-adiponectin, but did not change insulin sensitivity suggesting that ucOC does not affect insulin sensitivity in healthy postmenopausal women.",2021,"HOMA-IR and p-leptin did not change in the two groups.
","['postmenopausal women', 'healthy postmenopausal women', 'One hundred forty-eight postmenopausal women']","['menaquinone-7 (MK-7', 'placebo', 'MK-7 375\u2009µg daily or placebo, as an add-on to calcium (800\u2009mg) and vitamin D', 'Vitamin K2 (menaquinone-7', 'vitamin K2']","['S-ucOC', 'HOMA-IR and p-leptin', 'serum ucOC, insulin sensitivity by HOMA-IR, and plasma adiponectin and leptin', 'serum ucOC, bone mass, and insulin sensitivity', 'P-adiponectin', 'insulin sensitivity', 'concentration of undercarboxylated osteocalcin (ucOC']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0078382', 'cui_str': 'vitamin MK 7'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}]","[{'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",148.0,0.387178,"HOMA-IR and p-leptin did not change in the two groups.
","[{'ForeName': 'Sofie Hertz', 'Initials': 'SH', 'LastName': 'Rønn', 'Affiliation': 'Aarhus University Hospital, Department of Endocrinology and Internal medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Harsløf', 'Affiliation': 'Aarhus University Hospital, Department of Endocrinology and Internal medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Steen Bønløkke', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Steno Diabetes Center Aarhus, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Bente Lomholt', 'Initials': 'BL', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Department of Endocrinology and Internal medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark. bente.langdahl@aarhus.rm.dk.'}]",European journal of clinical nutrition,['10.1038/s41430-021-00884-8']
108,33675614,Qualitative Study on the Acceptability of and Adherence to a Vaginal Ring for HIV Prophylaxis Among Adolescent Girls.,"OBJECTIVE


This study aims to assess the product-related, relationship-related, and sex-related factors that act as facilitators and barriers to the acceptability of a vaginal ring (VR) for HIV prevention among adolescent girls.
DESIGN


Qualitative study.
METHODS


Ninety-six girls aged 15-17 years from 6 urban US sites were enrolled in MTN-023/IPM 030, a 24-week randomized controlled trial, for assessing the safety and acceptability of a dapivirine VR for HIV prevention. At week 24, 21 girls were randomly selected to participate in in-depth interviews. Interviews were transcribed verbatim and data analyzed using a thematic analysis approach. Facilitators and barriers to VR acceptability related to participants' relationships, sexual activity, and characteristics of the VR product were identified.
RESULTS


Factors related to relationships rarely seemed to act as barriers to VR acceptability; most participants disclosed VR use to sexual partners, and positive reactions from sexual partners, which were common, seemed to facilitate VR acceptability. Emotional and/or physical discomfort surrounding VR use during sex was mentioned occasionally as a barrier to VR acceptability. Product characteristics were most frequently mentioned as barriers to VR acceptability. Many participants reported concerns about the large size of the VR on first impression. Although most found the VR comfortable, some reported pain with VR insertion. Several participants were concerned about VR cleanliness, particularly during menstruation.
CONCLUSION


Product considerations, specifically size and use during menstruation, were the most commonly reported barriers to VR acceptability in this study. Adolescent girls may require additional counseling to assuage product concerns regarding a VR for HIV prevention.",2021,"RESULTS


Factors related to relationships rarely appeared to act as barriers to VR acceptability; most participants disclosed VR use to sexual partners, and positive reactions from sexual partners, which were common, appeared to facilitate VR acceptability.","['Ninety-six 15 to 17-year-old girls from six urban U.S. sites were enrolled in MTN-023/IPM 030', 'Adolescent girls', '21 girls were randomly selected to participate in in-depth-interviews', 'adolescent girls']",['dapivirine VR for HIV prevention'],[],"[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C1434916', 'cui_str': 'dapivirine'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],21.0,0.0159742,"RESULTS


Factors related to relationships rarely appeared to act as barriers to VR acceptability; most participants disclosed VR use to sexual partners, and positive reactions from sexual partners, which were common, appeared to facilitate VR acceptability.","[{'ForeName': 'Zoë', 'Initials': 'Z', 'LastName': 'Baker', 'Affiliation': ""Division of Urology, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Javanbakht', 'Affiliation': 'Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA.'}, {'ForeName': 'Janell', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Brosnan', 'Affiliation': 'Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Squires', 'Affiliation': 'Division of Infectious Diseases, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bunge', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Services, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Zimet', 'Affiliation': 'Department of Pediatrics, Indiana University, Bloomington, IA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mensch', 'Affiliation': 'Population Council, New York, NY.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Kapogiannis', 'Affiliation': 'Maternal and Pediatric Infectious Disease Branch, National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hoesley', 'Affiliation': 'Division of Infectious Diseases, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reirden', 'Affiliation': ""Department of Adolescent Medicine, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Gaur', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Department of Global Health and Population, Harvard School of Public Health, The Fenway Institute, Boston, MA; and.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Futterman', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, the Bronx, NY.'}, {'ForeName': 'Pamina', 'Initials': 'P', 'LastName': 'Gorbach', 'Affiliation': 'Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002674']
109,33714700,A New Approach on the pain management of intramuscular injection: A Triple-Blind Randomized Clinical Trial.,"BACKGROUND


Pain management is an important part of care provided by nurses.
AIMS


The present study aimed to investigate the effect of an innovative method named the skin traction, pressure, and rapid muscle release (TPR) on reducing IM injection pain compared with the Z-track injection method DESIGN: This triple-blind clinical trial investigated 63 patients who required Methocarbamol injection.
METHODS


Two, 5-cc methocarbamol injections were given to each patient by the two techniques in two of his/her muscles. In the TPR technique, after applying skin traction and imposing deep pressure on the muscle, the needle was inserted at a 90° angle near the skin and the muscle was released rapidly towards the needle. Hence, the needle was embedded in the muscle. However, muscle release was not applied in the Z-track method. The visual analog scale (VAS) was used to measure pain intensity. For data analysis, T-independent and χ 2  tests were used.
RESULTS


The findings showed that the mean pain score in TPR and Z-track methods was 1.68 ± 1.20 and 3.76 ± 1.42, respectively. The difference was statistically significant.
CONCLUSION


The results of this study showed that the innovative method (TPR) can be used as a substitute for the Z-track method to reduce IM injection pain.",2022,The results of this study showed that the innovative method (TPR) can be used as a substitute for the Z-track method to reduce IM injection pain.,['63 patients who required Methocarbamol injection'],"['innovative method named the skin traction, pressure, and rapid muscle release (TPR', 'innovative method (TPR']","['mean pain score', 'IM injection pain', 'pain intensity', 'visual analog scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4083766', 'cui_str': 'Methocarbamol Injection'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0278297', 'cui_str': 'Application of mechanical traction on skin'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0185184', 'cui_str': 'Division of muscle'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",63.0,0.0493628,The results of this study showed that the innovative method (TPR) can be used as a substitute for the Z-track method to reduce IM injection pain.,"[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Heshmatifar', 'Affiliation': 'Department of Nursing, School of Nursing, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Salari', 'Affiliation': 'Student Research Committee,Department of Nursing School of Nursing, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Rad', 'Affiliation': 'Iranian Research Center on Healthy Aging, Department of Nursing, Nursing and Midwifery School, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Tahoura', 'Initials': 'T', 'LastName': 'Afshari Saleh', 'Affiliation': 'Emergency Medicine Specialist, School of medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Borzoee', 'Affiliation': 'Non-communicable Research Center, School of Paramedics, Sabzevar University of Medical Sciences, Sabzevar, Iran. Electronic address: borzoee75026@yahoo.com.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Rastaghi', 'Affiliation': 'Department of Biostatistics, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2021.01.010']
110,33706602,The safety of clinically indicated replacement or routine replacement of peripheral intravenous catheters: A randomized controlled study.,"OBJECTIVE


The primary purpose of this study was to explore the safety of peripheral intravenous catheter (PIVC) replacement every 96 h compared to that of clinically indicated catheter removal.
METHODS


A prospective, single-blind, randomized controlled trial was conducted. A random number table method was used. Six hundred patients treated with PIVC intravenous infusion in 10 nursing units of a hospital from September to October 2019 were selected. Sixty were collected from each nursing unit, including 30 in the clinically indicated replacement group and 30 in the routine replacement group. The incidence of phlebitis, catheter-related infection (CRI), occlusion, infiltration, and any form of infusion therapy failure were compared between the two groups. SPSS 23.0 software was used.
RESULTS


The dwelling times of PIVC in the clinically indicated replacement group and routine replacement group were significantly different (hours) (83.62 ± 50.08, 69.75 ± 25.54,  t  = 3.021,  p  = 0.003). The incidence of any form of infusion therapy failure (RR = 4.448, 95% CI: 3.158-6.265,  p  < 0.001), phlebitis (RR = 2.416, 95% CI: 1.595-3.660,  p  < 0.001), occlusion (RR = 6.610, 95% CI: 3.062-14.268,  p  < 0.001), infiltration (RR = 2.607, 95% CI: 1.130-6.016,  p  = 0.020), accidental dislodgement (RR = 2.027, 95% CI: 1.868-2.200,  p  = 0.013), and pain at the insertion site (RR = 2.521, 95% CI: 1.742-3.649,  p  < 0.001) was higher in the clinically indicated replacement group than that in the routine replacement group. The overall survival curve of PIVC was drawn with Kaplan-Meier survival analysis. The median survival time of intravenous infusion was 59.58 h; the cumulative survival rates of 48 h, 72 h, and 96 h were 77.00%, 51.33%, and 20.33%, respectively.
CONCLUSION


Replacement of PIVC every 96 h is safer than clinically indicated.",2022,"The dwelling times of PIVC in the clinically indicated replacement group and routine replacement group were significantly different (hours) (83.62 ± 50.08, 69.75 ± 25.54,  t  = 3.021,  p  = 0.003).","['Sixty were collected from each nursing unit, including 30 in the clinically indicated replacement group and 30 in the routine replacement group', 'Six hundred patients treated with PIVC intravenous infusion in 10 nursing units of a hospital from September to October 2019 were selected']","['peripheral intravenous catheter (PIVC) replacement', 'peripheral intravenous catheters']","['overall survival curve of PIVC', 'phlebitis', 'incidence of any form of infusion therapy failure', 'pain', 'incidence of phlebitis, catheter-related infection (CRI), occlusion, infiltration, and any form of infusion therapy failure', 'cumulative survival rates', 'median survival time', 'dwelling times of PIVC', 'accidental dislodgement']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0860239', 'cui_str': 'Infection associated with catheter'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0010456', 'cui_str': 'Cumulative Survival Rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0000924', 'cui_str': 'Accident'}]",,0.222479,"The dwelling times of PIVC in the clinically indicated replacement group and routine replacement group were significantly different (hours) (83.62 ± 50.08, 69.75 ± 25.54,  t  = 3.021,  p  = 0.003).","[{'ForeName': 'Huapeng', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': ""Department of Hepatobiliary and Pancreas Surgery, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Qinling', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': ""Department of Hepatobiliary and Pancreas Surgery, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Hilal Mohamed', 'Initials': 'HM', 'LastName': 'Nor', 'Affiliation': ""School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': ""Department of Hepatobiliary and Pancreas Surgery, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Nursing, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xin', 'Affiliation': ""Department of Nursing, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Aifang', 'Initials': 'A', 'LastName': 'Feng', 'Affiliation': ""Department of Hepatobiliary and Pancreas Surgery, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Hepatobiliary and Pancreas Surgery, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopaedics, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': ""Department of Neurology, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Juanli', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Cardiovascular Medicine Department, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Xiaoye', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Neurosurgery, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Nephrology, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Jianfang', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': ""Department of Thoracic Surgery, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xie', 'Affiliation': ""Department of Urology, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.""}]",The journal of vascular access,['10.1177/1129729821998528']
111,33722112,"Influence of online comments on smokers' E-cigarette attitude: Opinion climate, review fraud, and resistance to persuasion.","OBJECTIVE


This study examined the effect of online comments on smokers' attitude toward trying e-cigarettes. It also explored the effect of an unobtrusive forewarning in increasing smokers' resistance to online review fraud.
DESIGN


739 adult smokers participated in an experiment with a 2 comment valence (supportive vs. oppositional) x 3 comment deception warning (no warning vs. early warning vs. late warning) + 1 control (no comment) factorial design. Smokers watched two e-cigarette commercials. The control group received only the ads. The treatment groups saw 10 to 12 comments following each ad.Main Outcome Measure: E-cigarette attitude.
RESULTS


Smokers who read supportive (M = 5.28, SD = 1.37), oppositional (M = 4.96, SD = 1.53), and no comment (M = 5.44, SD = 1.20) showed significant difference on their e-cigarettes attitude, p = .004. When the comment climate was overly in favor of e-cigarettes, warning smokers of review fraud could raise their awareness of comment deception, increase defensive processing, decrease their social identification with commenters, and eventually lower their interest in trying e-cigarettes.
CONCLUSION


The overall opinion climate in the form of aggregated valence of comments could sway smokers' e-cigarette attitude. Smokers could benefit from warnings of online review fraud.",2022,"RESULTS


Smokers who read supportive (M = 5.28, SD = 1.37), oppositional (M = 4.96, SD","[""smokers' attitude toward trying e-cigarettes"", '739 adult smokers participated in an experiment with a 2', ""smokers' E-cigarette attitude"", 'Smokers who read supportive (M\u2009=\u20095.28, SD = 1.37), oppositional (M\u2009=\u20094.96, SD']",['comment valence (supportive vs. oppositional) x 3 comment deception warning (no warning vs. early warning vs. late warning) + 1 control (no comment) factorial design'],['\xa0E-cigarette attitude'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}]","[{'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0024195', 'cui_str': 'Deception'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",739.0,0.116577,"RESULTS


Smokers who read supportive (M = 5.28, SD = 1.37), oppositional (M = 4.96, SD","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'Department of Communication Studies, Ric Edelman College of Communication & Creative Arts, Rowan University, Glassboro, New Jersey, USA.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Communication Studies, University of Georgia, Athens, Georgia, USA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Cappella', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]",Psychology & health,['10.1080/08870446.2021.1893320']
112,33734099,A Randomized Trial of a Brief Behavioral Intervention for PrEP Uptake Among Men Who Have Sex With Men at Increased Risk for HIV Infection.,"BACKGROUND


The aim of this study was to evaluate the efficacy of a novel, brief 2-session behavioral intervention to promote HIV pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) who are behaviorally at risk for HIV.
SETTING


A pilot randomized controlled trial was conducted at a sexually transmitted infection (STI) clinic to compare a brief motivational interviewing intervention with passive referral only for PrEP uptake.
METHODS


MSM who scored as ""high risk"" on the HIV Incidence Risk index for MSM was offered a brief (15-20 minutes) motivational interviewing-based intervention at the time of STI testing to address barriers to PrEP uptake, including low risk perception, stigma, side effects, and cost. The initial session was followed by a brief, telephone booster session that lasted <10 minutes. The primary outcome was attending a clinical PrEP appointment and accepting a prescription for PrEP.
RESULTS


Participants were recruited from an urban STI clinic in the United States. A total of 86 MSM who were behaviorally at risk for HIV were enrolled in the study (N = 43 intervention; N = 43 treatment-as-usual, ""TAU""). Participants randomized to the intervention were significantly more likely to attend a clinical appointment and accept a prescription for PrEP, compared with treatment-as-usual (52.3% versus 27.9%, respectively; odds ratio = 3.6; 95% confidence interval: 1.5 to 8.9; P = 0.005).
CONCLUSIONS


A brief behavioral intervention focused on the initial steps in the PrEP care cascade demonstrated preliminary efficacy in promoting uptake among MSM who are behaviorally at risk for HIV.",2021,A brief behavioral intervention focused on the initial steps in the PrEP care cascade demonstrated preliminary efficacy in promoting uptake among MSM who are behaviorally at risk for HIV.,"['MSM who scored as ""high-risk"" on the HIV Incidence Risk Index for MSM (HIRI-MSM) were offered a brief (15-20 minutes', 'sexually transmitted infection (STI) clinic', 'men who have sex with men at increased risk for HIV infection', 'A total of 86 MSM who were behaviorally at risk for HIV were enrolled in the study (N=43 intervention; N=43 treatment-as-usual, ""TAU', 'Participants were recruited from an urban STI clinic in the USA', 'men who have sex with men (MSM) who are behaviorally at risk for HIV']","['HIV pre-exposure prophylaxis (PrEP', 'motivational interviewing (MI) intervention', 'behavioral intervention']","['clinical PrEP appointment and accepting a prescription for PrEP', 'low risk perception, stigma, side-effects, and cost', 'likely to attend a clinical appointment and accept a prescription for PrEP']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]",86.0,0.207176,A brief behavioral intervention focused on the initial steps in the PrEP care cascade demonstrated preliminary efficacy in promoting uptake among MSM who are behaviorally at risk for HIV.,"[{'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Chan', 'Affiliation': 'Departments of Medicine; and.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Nunn', 'Affiliation': 'Behavioral and Social Sciences, Brown University, Providence, RI.'}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'van den Berg', 'Affiliation': 'Departments of Medicine; and.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cormier', 'Affiliation': 'Departments of Medicine; and.'}, {'ForeName': 'Genoviva', 'Initials': 'G', 'LastName': 'Sowemimo-Coker', 'Affiliation': 'Departments of Medicine; and.'}, {'ForeName': 'Siena C', 'Initials': 'SC', 'LastName': 'Napoleon', 'Affiliation': 'Departments of Medicine; and.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University, Providence, RI.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Moitra', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University, Providence, RI.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002671']
113,34129232,"Effect of a Probiotic Supplement Containing Lactobacillus Acidophilus and Bifidobacterium Animalis Lactis on Urine Oxalate in Calcium Stone Formers with Hyperoxaluria: A Randomized, Placebo-controlled, Double-blind and In-vitro Trial.","PURPOSE


To determine the effect of a probiotic supplement containing native Lactobacillus acidophilus (L. acidophilus) and Bifidobacterium animalis lactis (B. lactis) on 24-hour urine oxalate in recurrent calcium stone formers with hyperoxaluria. Moreover, the in-vitro oxalate degradation capacity and the intestinal colonization of consumed probiotics were evaluated.
MATERIALS AND METHODS


The oxalate degrading activity of L. acidophilus and B. lactis were evaluated in-vitro. The presence of oxalyl-CoA decarboxylase (oxc) gene in the probiotic species was assessed. One hundred patients were randomized to receive the probiotic supplement or placebo for four weeks. The 24-hour urine oxalate and the colonization of consumed probiotics were assessed after weeks four and eight.
RESULTS


Although the oxc gene was present in both species, only L. acidophilus had a good oxalate degrading activity, in-vitro. Thirty-four patients from the probiotic and thirty patients from the placebo group finished the study. The urine oxalate changes were not significantly different between groups (57.21 ± 11.71 to 49.44 ± 18.14 mg/day for probiotic, and 56.43 ± 9.89 to 50.47 ± 18.04 mg/day for placebo) (P = .776). The probiotic consumption had no significant effect on urine oxalate, both in univariable (P = .771) and multivariable analyses (P = .490). The consumed probiotics were not detected in the stool samples of most participants.
CONCLUSION


Our results showed that the consumption of a probiotic supplement containing L. acidophilus and B. lactis did not affect urine oxalate. The results may be due to a lack of bacterial colonization in the intestine.",2021,"The probiotic consumption had no significant effect on urine oxalate, both in univariable (P = .771) and multivariable analyses (P = .490).","['recurrent calcium stone formers with hyperoxaluria', 'Calcium Stone Formers with Hyperoxaluria', 'Thirty-four patients from the probiotic and thirty patients from the', 'One hundred patients']","['probiotic supplement or placebo', 'Placebo', 'placebo', 'probiotic supplement containing native Lactobacillus acidophilus (L. acidophilus) and Bifidobacterium animalis lactis (B. lactis', 'Probiotic Supplement Containing Lactobacillus Acidophilus and Bifidobacterium Animalis Lactis']","['24-hour urine oxalate and the colonization of consumed probiotics', 'urine oxalate changes', 'urine oxalate']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0020500', 'cui_str': 'Hyperoxaluria'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0428153', 'cui_str': 'Urine oxalate measurement'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",100.0,0.119774,"The probiotic consumption had no significant effect on urine oxalate, both in univariable (P = .771) and multivariable analyses (P = .490).","[{'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Tavasoli', 'Affiliation': 'Assistant Professor, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, I.R. Iran . sanaz.tavasoli@gmail.com.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Jalali', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, I.R. Iran. sbi.jalali@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Naji', 'Affiliation': 'Assistant Professor, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, I.R. Iran. mohammadnaji@sbmu.ac.ir.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Borumandnia', 'Affiliation': 'Assistant Professor, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, I.R. Iran. borumand.n@gmail.com.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Shakiba Majd', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, I.R. Iran. gh.shakibamajd@gmail.com.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Basiri', 'Affiliation': 'Professor, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, I.R. Iran. basiri@unrc.ir.'}, {'ForeName': 'Kianaoush', 'Initials': 'K', 'LastName': 'Khosravi Darani', 'Affiliation': 'Professor, Research Department of Food Technology Research, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, I.R. Iran. k.khosravi@sbmu.ac.ir.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Karamad', 'Affiliation': 'Research Department of Food Technology Research, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, I.R. Iran. dina.karamad@sbmu.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Associate Professor, Department of Biology, Central Tehran Branch, Islamic Azad University, Tehran, I.R. Iran. ebrahimi_mt@yahoo.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Assistant Professor, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, I.R. Iran. taheri233@yahoo.com.'}]",Urology journal,['10.22037/uj.v18i.6789']
114,33750673,Effects of a mixed exercise program on cancer related-fatigue and health-related quality of life in oncogeriatric patients: A feasibility study.,"OBJECTIVES


Cancer-related fatigue (CRF) is the most debilitating side effect occurring with cancer treatment accumulation. Although combining aerobic and resistance exercise is an effective strategy to counteract this side effect, there is a paucity of studies performed with older patients even if this is the most affected population. Hence, the objective was to assess the feasibility and the impact of a twelve-week exercise program performed during cancer treatment on CRF, quality of life, and physical capacity in older adults diagnosed with early-stage cancer.
MATERIAL AND METHODS


Twenty patients with cancer (70 ± 4 years) beginning systemic cancer treatments were recruited and randomized into two groups: 1) aerobic and resistance training (MIX) and 2) stretching (CON). Both groups were supervised three times/week for a total of twelve weeks. The primary outcome was feasibility and secondary outcomes were CRF (FACIT-Fatigue questionnaire), health-related quality of life (HRQoL) (EORTC QLQ-C30 questionnaire) and physical capacity (6MWT and grip strength).
RESULTS


In Mix, both exercise adherence (88.2%) and completion rate (86.6%) were high, which suggests that exercise is feasible in an oncologic context. In the MIX group, HRQoL improved (p = 0.05) and CRF was clinically, ableit non-significantly (p = 0.09), decreased. Concerning physical capacity, MIX showed a clinical improvement in the 6MWT during the intervention (p = 0.002) compared to CON.
CONCLUSION


This study suggests that, in older patients with cancer undergoing adjuvant or neoadjuvant systemic treatments, a mixed exercise program is feasible, well tolerated and might help mitigate CRF and HRQoL decrements.",2021,"In the MIX group, HRQoL improved (p = 0.05) and CRF was clinically, ableit non-significantly (p = 0.09), decreased.","['oncogeriatric patients', 'older adults diagnosed with early-stage cancer', 'Twenty patients with cancer (70\xa0±\xa04\xa0years) beginning systemic cancer treatments', 'older patients with cancer undergoing adjuvant or neoadjuvant systemic treatments']","['aerobic and resistance exercise', 'mixed exercise program', 'aerobic and resistance training (MIX) and 2) stretching (CON']","['CRF, quality of life, and physical capacity', 'cancer related-fatigue and health-related quality of life', 'HRQoL', 'CRF (FACIT-Fatigue questionnaire), health-related quality of life (HRQoL) (EORTC QLQ-C30 questionnaire) and physical capacity (6MWT and grip strength', 'completion rate', 'CRF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",20.0,0.0524151,"In the MIX group, HRQoL improved (p = 0.05) and CRF was clinically, ableit non-significantly (p = 0.09), decreased.","[{'ForeName': 'Fontvieille', 'Initials': 'F', 'LastName': 'Adeline', 'Affiliation': ""Faculty of Physical Activity Sciences, University of Sherbrooke, 2500 boulevard de l'université, Sherbrooke, Quebec J1K 2R1, Canada; Research Centre on Aging, CIUSSS de l'Estrie - CHUS, 1036 rue Belvédère Sud, Sherbrooke, Quebec J1H 4C4, Canada.""}, {'ForeName': 'Parent-Roberge', 'Initials': 'PR', 'LastName': 'Hugo', 'Affiliation': ""Faculty of Physical Activity Sciences, University of Sherbrooke, 2500 boulevard de l'université, Sherbrooke, Quebec J1K 2R1, Canada; Research Centre on Aging, CIUSSS de l'Estrie - CHUS, 1036 rue Belvédère Sud, Sherbrooke, Quebec J1H 4C4, Canada.""}, {'ForeName': 'Maréchal', 'Initials': 'M', 'LastName': 'René', 'Affiliation': ""Faculty of Physical Activity Sciences, University of Sherbrooke, 2500 boulevard de l'université, Sherbrooke, Quebec J1K 2R1, Canada; Research Centre on Aging, CIUSSS de l'Estrie - CHUS, 1036 rue Belvédère Sud, Sherbrooke, Quebec J1H 4C4, Canada.""}, {'ForeName': 'Fülöp', 'Initials': 'F', 'LastName': 'Tàmàs', 'Affiliation': ""Research Centre on Aging, CIUSSS de l'Estrie - CHUS, 1036 rue Belvédère Sud, Sherbrooke, Quebec J1H 4C4, Canada; Faculty of Medicine and Health Sciences, University of Sherbrooke, 3001 12 Avenue Nord, Quebec J1H 5N4, Canada.""}, {'ForeName': 'Riesco', 'Initials': 'R', 'LastName': 'Eléonor', 'Affiliation': ""Faculty of Physical Activity Sciences, University of Sherbrooke, 2500 boulevard de l'université, Sherbrooke, Quebec J1K 2R1, Canada; Research Centre on Aging, CIUSSS de l'Estrie - CHUS, 1036 rue Belvédère Sud, Sherbrooke, Quebec J1H 4C4, Canada. Electronic address: E.Riesco@USherbrooke.ca.""}, {'ForeName': 'Pavic', 'Initials': 'P', 'LastName': 'Michel', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Sherbrooke, 3001 12 Avenue Nord, Quebec J1H 5N4, Canada; Centre de recherche du CHUS, 12 Avenue Nord, Quebec J1H 5N4, Canada.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2021.02.025']
115,33813982,Effect of computer-based multisensory program on English reading skills of students with Dyslexia and reading difficulties.,"The study evaluated the effectiveness of a computer-based Multi-Sensory Program (MSP) on English reading skills as a second language of fourth-grade students with reading difficulties and Dyslexia in the United Arab Emirates (UAE). Pretest-Posttest experimental design was used in this study. The analysis showed that average pretest score in both the experimental and control groups was almost the same and the average post-test score was much higher in the experimental group as compared to the control group. Moreover, results also reveal statistically significant difference in the students' mean scores between the experimental and control groups after the MSP intervention. The study has implications in the UAE and Arab countries and everywhere in the world for students who are learning English as a second language and facing reading difficulties. Besides, the modified MSP used in this study can be adopted and imitated to create a local version in the Arabic language in the Middle East and in other countries that are teaching Arabic as a second language.",2022,"Moreover, results also reveal statistically significant difference in the students' mean scores between the experimental and control groups after the MSP intervention.","['English reading skills as a second language of fourth-grade students with reading difficulties and Dyslexia in the United Arab Emirates (UAE', 'English reading skills of students with Dyslexia and reading difficulties']","['computer-based multisensory program', 'computer-based Multi-Sensory Program (MSP']",['average pretest score'],"[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0557074', 'cui_str': 'Second language'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0586742', 'cui_str': 'Difficulty reading'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0179255,"Moreover, results also reveal statistically significant difference in the students' mean scores between the experimental and control groups after the MSP intervention.","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Gharaibeh', 'Affiliation': 'Al Ain University, Al Ain, UAE.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Dukmak', 'Affiliation': 'Al Ain University, Al Ain, UAE.'}]",Applied neuropsychology. Child,['10.1080/21622965.2021.1898395']
116,33780297,A combined health action process approach and mHealth intervention to reduce sedentary behaviour in university students - a randomized controlled trial.,"Objective:  This investigation evaluated the effectiveness of a Health Action Process Approach (HAPA) based planning intervention augmented with text messages to reduce student-related sitting time (primary outcome) and increase specific non-sedentary behaviours. Relationships between the HAPA volitional constructs and sedentary and non-sedentary behaviours were also explored.  Design:  University students ( M age  = 21.13 y; SD = 4.81) were randomized into either a HAPA intervention (n = 28) or control (n = 33) condition.  Main Outcome Measures:  School-related sitting time, time spent in specific non-sedentary behaviours and HAPA volitional constructs were assessed at baseline, weeks 2, 4, 6 (post-intervention) and 8 (follow-up).  Results:  Significant group by time interaction effects favouring the intervention group were found for sitting time ( p  = 0.004, ɳ p 2  = 0.10), walking time ( p  = 0.021, ɳ p 2  = 0.06) and stretching time ( p  = 0.023, ɳ p 2  = 0.08), as well as for action planning ( p  < 0.001, ɳ p 2  = 0.17), coping planning ( p  < 0.001, ɳ p 2  = 0.20) and action control ( p  < 0.001, ɳ p 2  = 0.20). Significant correlations ( p  < 0.05) were also found between the HAPA constructs and sitting-related outcomes.  Conclusions:  Combining a HAPA-based planning intervention with text messages can reduce student-related sitting time in university students.
Supplemental data for this article is available online at https://doi.org/10.1080/08870446.2021.1900574 .",2022,"Significant group by time interaction effects favouring the intervention group were found for sitting time ( p  = 0.004, ɳ p 2  = 0.10), walking time ( p  = 0.021, ɳ p 2  = 0.06) and stretching time ( p  = 0.023, ɳ p 2  = 0.08), as well as for action planning ( p  < 0.001, ɳ p 2  = 0.17), coping planning ( p  < 0.001, ɳ p 2  = 0.20) and action control ( p  < 0.001, ɳ p 2  = 0.20).","['University students ( M age  = 21.13', 'university students']","['Health Action Process Approach (HAPA) based planning intervention', 'HAPA intervention', 'mHealth intervention', 'HAPA-based planning intervention with text messages']","['walking time', 'School-related sitting time, time spent in specific non-sedentary behaviours and HAPA volitional constructs', 'sedentary behaviour', 'time interaction effects', 'sitting time', 'stretching time', 'coping planning']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",,0.0445315,"Significant group by time interaction effects favouring the intervention group were found for sitting time ( p  = 0.004, ɳ p 2  = 0.10), walking time ( p  = 0.021, ɳ p 2  = 0.06) and stretching time ( p  = 0.023, ɳ p 2  = 0.08), as well as for action planning ( p  < 0.001, ɳ p 2  = 0.17), coping planning ( p  < 0.001, ɳ p 2  = 0.20) and action control ( p  < 0.001, ɳ p 2  = 0.20).","[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Dillon', 'Affiliation': 'Faculty of Health Sciences, School of Kinesiology, The University of Western Ontario, London, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rollo', 'Affiliation': ""Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': 'Faculty of Health Sciences, School of Kinesiology, The University of Western Ontario, London, Canada.'}]",Psychology & health,['10.1080/08870446.2021.1900574']
117,33764845,"Family Connections randomized controlled trial: assessing the feasibility and acceptability of an intervention with adolescents living with HIV and their caregivers in Ndola, Zambia.","Achieving the 95-95-95 UNAIDS targets requires meeting the needs of adolescents, however we lack evidenced-based approaches to improving adolescent adherence to antiretroviral therapy (ART), increasing viral suppression, and supporting general wellbeing. We developed  Family Connections  as a group intervention for adolescents and their adult caregivers and conducted a randomized controlled trial in Ndola, Zambia to test feasibility and acceptability. Fifty pairs ( n  = 100) of adolescents (15-19 years and on ART ≥ 6 months) and their caregivers were randomly assigned either to the intervention consisting of 10 group sessions over 6 months, or to a comparison group, which received the usual care. Each pair completed baseline and endline surveys, with adolescents also undergoing viral load testing. Of the 24-intervention adolescent/caregiver pairs, 88% attended at least eight group sessions. Most adolescents (96%) and all caregivers would recommend  Family Connections  to peers. Adolescent viral failure decreased but did not significantly differ by study group. Adolescents in the intervention group showed a greater reduction in HIV-related feelings of worthlessness and shame than the comparison group. The feasibility, acceptability, and the positive trend toward significantly reducing internalized stigma, generated by this  Family Connections  pilot study, contributes valuable data to support adolescent/caregiver approaches that use peer groups.",2022,Adolescents in the intervention group showed a greater reduction in HIV-related feelings of worthlessness and shame than the comparison group.,"['Fifty pairs ( n\u2009 =\u2009100) of adolescents (15-19 years and on ART\u2009≥\u20096 months) and their caregivers', 'adolescents and their adult caregivers', 'adolescents living with HIV and their caregivers in Ndola, Zambia']",[],"['HIV-related feelings of worthlessness and shame', 'Adolescent viral failure']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0855235', 'cui_str': 'Feelings of worthlessness'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.163965,Adolescents in the intervention group showed a greater reduction in HIV-related feelings of worthlessness and shame than the comparison group.,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Denison', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Packer', 'Affiliation': 'Reproductive, Maternal, Newborn, and Child Health, FHI 360, Durham, NC, USA.'}, {'ForeName': 'Namakau', 'Initials': 'N', 'LastName': 'Nyambe', 'Affiliation': 'Zambia Country Office, FHI 360, Lusaka, Zambia.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'Reproductive, Maternal, Newborn, and Child Health, FHI 360, Durham, NC, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Caldas', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Miti', 'Affiliation': ""Arthur Davison Children's Hospital, Ndola, Zambia.""}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Sudarsan', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Biostatistics, FHI 360, Durham, NC, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Bernholc', 'Affiliation': 'Biostatistics, FHI 360, Durham, NC, USA.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Mwansa', 'Affiliation': ""Arthur Davison Children's Hospital, Ndola, Zambia.""}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'McCarraher', 'Affiliation': 'Reproductive, Maternal, Newborn, and Child Health, FHI 360, Durham, NC, USA.'}]",AIDS care,['10.1080/09540121.2021.1902935']
118,34128780,Effectiveness of Personalized Cognitive Stimulation in Older Adults with Mild Possible Cognitive Impairment: A 12-month Follow-up Cognitive Stimulation in Mild Cognitive Impairment.,"OBJECTIVE


The objective of this study was to analyze the long-term effects of a personalized cognitive stimulation (PCS) program on the global cognition, cognitive aspects, activities of daily living (ADLs), anxiety, and depression in older adults with possible mild cognitive impairment (MCI).
METHODS


A 12-month follow-up analysis was carried out in a single-blind, randomized clinical trial to research the long-term effects of a 10-week PCS program evaluating the cognitive level, depression, and anxiety of older adults with possible MCI.
RESULTS


Fifty older adults were assessed 12 months after the CS program, 23 in the intervention group and 27 in the control group. There were significant differences between the groups at 12 months in the global cognition ( p  = .002), in global orientation ( p  < .001), and in spatial orientation ( p  = .004) in favor of the intervention group, measured with the Spanish version of the Mini-Mental Status Examination (MEC-35).
CONCLUSIONS


A PCS program could be effective in improving global cognition and global and spatial orientation.
CLINICAL IMPLICATIONS


A PCS program based on cognitive levels in older adults with possible MCI achieves improvements in global cognition and global and spatial orientation. PCS programs can be applied successfully by trained occupational therapists.",2022,"There were significant differences between the groups at 12 months in the global cognition ( p  = .002), in global orientation ( p  < .001), and in spatial orientation ( p  = .004) in favor of the intervention group, measured with the Spanish version of the Mini-Mental Status Examination (MEC-35).","['Mild Cognitive Impairment', 'older adults with possible mild cognitive impairment (MCI', 'older adults with possible', 'Fifty older adults', 'older adults with possible MCI', 'Older Adults with Mild Possible Cognitive Impairment']","['Personalized Cognitive Stimulation', 'PCS program', 'MCI', 'personalized cognitive stimulation (PCS) program']","['Spanish version of the Mini-Mental Status Examination (MEC-35', 'global cognition', 'global cognition, cognitive aspects, activities of daily living (ADLs), anxiety, and depression', 'cognitive level, depression, and anxiety', 'global orientation', 'global cognition and global and spatial orientation', 'spatial orientation']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0206694', 'cui_str': 'Mucoepidermoid carcinoma'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0243151', 'cui_str': 'cognitive aspects'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0037744', 'cui_str': 'Space Perception'}]",50.0,0.0370669,"There were significant differences between the groups at 12 months in the global cognition ( p  = .002), in global orientation ( p  < .001), and in spatial orientation ( p  = .004) in favor of the intervention group, measured with the Spanish version of the Mini-Mental Status Examination (MEC-35).","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Gómez-Soria', 'Affiliation': 'Departamento de Fisiatría y Enfermería, Facultad de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Brandín-de la Cruz', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Zaragoza, Spain.'}, {'ForeName': 'Juan Nicolás', 'Initials': 'JN', 'LastName': 'Cuenca Zaldívar', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Ciencias de la Salud, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Calvo', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Zaragoza, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'Departamento de Fisiatría y Enfermería, Facultad de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Calatayud', 'Affiliation': 'Departamento de Fisiatría y Enfermería, Facultad de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Spain.'}]",Clinical gerontologist,['10.1080/07317115.2021.1937764']
119,33753537,Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial.,"BACKGROUND


In patients with normal renal function or early stage CKD, the risk-benefit profile of direct oral anticoagulants (DOACs) is superior to that of vitamin K antagonists (VKAs). In patients on hemodialysis, the comparative efficacy and safety of DOACs versus VKAs are unknown.
METHODS


In the Valkyrie study, 132 patients on hemodialysis with atrial fibrillation were randomized to a VKA with a target INR of 2-3, 10 mg rivaroxaban daily, or rivaroxaban and vitamin K2 for 18 months. Patients continued the originally assigned treatment and follow-up was extended for at least an additional 18 months. The primary efficacy end point was a composite of fatal and nonfatal cardiovascular events. Secondary efficacy end points were individual components of the composite outcome and all-cause death. Safety end points were life-threatening, major, and minor bleeding.
RESULTS


Median (IQR) follow-up was 1.88 (1.01-3.38) years. Premature, permanent discontinuation of anticoagulation occurred in 25% of patients. The primary end point occurred at a rate of 63.8 per 100 person-years in the VKA group, 26.2 per 100 person-years in the rivaroxaban group, and 21.4 per 100 person-years in the rivaroxaban and vitamin K2 group. The estimated competing risk-adjusted hazard ratio for the primary end point was 0.41 (95% CI, 0.25 to 0.68;  P =0.0006) in the rivaroxaban group and 0.34 (95% CI, 0.19 to 0.61;  P =0.0003) in the rivaroxaban and vitamin K2 group, compared with the VKA group. Death from any cause, cardiac death, and risk of stroke were not different between the treatment arms, but symptomatic limb ischemia occurred significantly less frequently with rivaroxaban than with VKA. After adjustment for competing risk of death, the hazard ratio for life-threatening and major bleeding compared with the VKA group was 0.39 (95% CI, 0.17 to 0.90;  P =0.03) in the rivaroxaban group, 0.48 (95% CI, 0.22 to 1.08;  P =0.08) in the rivaroxaban and vitamin K2 group and 0.44 (95% CI, 0.23 to 0.85;  P =0.02) in the pooled rivaroxaban groups.
CONCLUSIONS


In patients on hemodialysis with atrial fibrillation, a reduced dose of rivaroxaban significantly decreased the composite outcome of fatal and nonfatal cardiovascular events and major bleeding complications compared with VKA.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Oral Anticoagulation in Hemodialysis, NCT03799822.",2021,"Death from any cause, cardiac death, and risk of stroke were not different between the treatment arms, but symptomatic limb ischemia occurred significantly less frequently with rivaroxaban than with VKA.","['132 patients on hemodialysis with atrial fibrillation', 'Hemodialysis Patients with Atrial Fibrillation', 'patients with normal renal function or early stage CKD']","['Vitamin K Antagonists', 'Rivaroxaban', 'vitamin K antagonists (VKAs', 'rivaroxaban daily, or rivaroxaban and vitamin K2', 'VKA', 'rivaroxaban']","['hazard ratio for life-threatening and major bleeding', 'individual components of the composite outcome and all-cause death', 'symptomatic limb ischemia', 'Premature, permanent discontinuation of anticoagulation', 'Death from any cause, cardiac death, and risk of stroke', 'composite of fatal and nonfatal cardiovascular events', 'composite outcome of fatal and nonfatal cardiovascular events and major bleeding complications', 'life-threatening, major, and minor bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",132.0,0.314542,"Death from any cause, cardiac death, and risk of stroke were not different between the treatment arms, but symptomatic limb ischemia occurred significantly less frequently with rivaroxaban than with VKA.","[{'ForeName': 'An S', 'Initials': 'AS', 'LastName': 'De Vriese', 'Affiliation': 'Division of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Bruges, Belgium an.devriese@azsintjan.be.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Caluwé', 'Affiliation': 'Division of Nephrology, OLV Hospital, Aalst, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Der Meersch', 'Affiliation': 'Division of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Bruges, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'De Boeck', 'Affiliation': 'Division of Nephrology, ZNA Hospital, Antwerp, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'De Bacquer', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020111566']
120,33780086,"Separating EEG correlates of stress: Cognitive effort, time pressure, and social-evaluative threat.","The prefrontal cortex is a key player in stress response regulation. Electroencephalographic (EEG) responses, such as a decrease in frontal alpha and an increase in frontal beta power, have been proposed to reflect stress-related brain activity. However, the stress response is likely composed of different parts such as cognitive effort, time pressure, and social-evaluative threat, which have not been distinguished in previous studies. This distinction, however, is crucial if we aim to establish reliable tools for early detection of stress-related conditions and monitoring of stress responses throughout treatment. This randomized cross-over study (N = 38) aimed to disentangle EEG correlates of stress. With linear mixed models accounting for missing values in some conditions, we found a decrease in frontal alpha and increase in beta power when performing the Paced Auditory Serial Addition Test (PASAT; cognitive effort; n = 32) compared to resting state (n = 33). No change in EEG power was found when the PASAT was performed under time pressure (n = 29) or when adding social-evaluative threat (video camera; n = 29). These findings suggest that frontal EEG power can discriminate stress from resting state but not more fine-grained differences of the stress response.",2022,No change in EEG power was found when the PASAT was performed under time pressure (n = 29) or when adding social-evaluative threat (video camera; n = 29).,[],['PASAT'],"['Separating EEG Correlates of Stress: Cognitive Effort, Time Pressure, and Social-evaluative Threat', 'Electroencephalographic (EEG) responses', 'EEG power', 'frontal alpha and increase in beta power']",[],"[{'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",,0.013259,No change in EEG power was found when the PASAT was performed under time pressure (n = 29) or when adding social-evaluative threat (video camera; n = 29).,"[{'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Ehrhardt', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fietz', 'Affiliation': 'Department of Translational Research in Psychiatry, Max-Planck-Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kopf-Beck', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kappelmann', 'Affiliation': 'Department of Translational Research in Psychiatry, Max-Planck-Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Anna-Katharine', 'Initials': 'AK', 'LastName': 'Brem', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}]",The European journal of neuroscience,['10.1111/ejn.15211']
121,34115660,A Pilot Randomized Trial of Polypectomy Techniques for 4 to 6 mm Colonic Polyps.,"BACKGROUND AND GOALS


There is variation in polypectomy techniques for resection of small polyps. Aim was to compare techniques for 4 to 6 mm polyps for recurrent adenoma, efficiency, and adverse events and to establish methodological factors for definitive trial.
MATERIALS AND METHODS


The study was a randomized controlled trial. Outpatients with ≥1, 4 to 6 mm polyps were randomized to cold forceps (CF), cold snare (CS), and hot snare (HS). Polypectomy site was marked with SPOT to assess for recurrence at the original polypectomy site during surveillance colonoscopy. To assess feasibility of a definitive trial we measured (1) rates of patient refusal, participation, ineligibility; (2) retention; (3) recurrent neoplasia; and (4) sample size for a definitive trial.
RESULTS


Three hundred fifty-three patients were randomized to 1 of the 3 polypectomy techniques, of whom 260 (73.6%) completed the initial colonoscopy (mean age 57 y, 50.4% women), with 91, 87, and 82 patients randomized to CF, CS, and HS polypectomy, respectively. Mean time for polyp resection for CF, CS, and HS were 198.8, 58.5, and 96.8 seconds, respectively, with CS and HS requiring less time than CF (P<0.001). One hundred sixty-four (63.1%) completed surveillance colonoscopy. Polyp recurrences were 9 (14.5%) with CF, 5 (9.6%) with CS, and 0 (0%) with HS. Although the recurrence relative risks with CF and CS polypectomy were 1.84 and 1.65 as compared with HS, respectively, neither was statistically significant.
CONCLUSIONS


CS and HS polypectomy require less time than CF. HS polypectomy may have a lower risk for recurrent neoplasia. High attrition rate is a challenge in conducting randomized controlled trial with polyp recurrence as endpoint.",2022,"Although the recurrence relative risks with CF and CS polypectomy were 1.84 and 1.65 as compared with HS, respectively, neither was statistically significant.
","['One hundred sixty-four (63.1%) completed surveillance colonoscopy', '4 to 6\u2009mm Colonic Polyps', 'Outpatients with ≥1, 4 to 6\u2009mm polyps', 'Three hundred fifty-three patients were randomized to 1 of the 3 polypectomy techniques, of whom 260 (73.6%) completed the initial colonoscopy (mean age 57\u2009y, 50.4% women), with 91, 87, and 82 patients randomized to']","['Polypectomy Techniques', 'cold forceps (CF), cold snare (CS), and hot snare (HS', 'HS polypectomy', 'CF, CS, and HS polypectomy']","['rates of patient refusal, participation, ineligibility; (2) retention; (3) recurrent neoplasia', 'Mean time for polyp resection for CF, CS, and HS', 'Polyp recurrences', 'recurrence relative risks with CF and CS polypectomy']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0009376', 'cui_str': 'Polyp of colon'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0183362', 'cui_str': 'Snare'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0183362', 'cui_str': 'Snare'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",353.0,0.404245,"Although the recurrence relative risks with CF and CS polypectomy were 1.84 and 1.65 as compared with HS, respectively, neither was statistically significant.
","[{'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Fatima', 'Affiliation': 'Department of Internal Medicine/Division of Gastroenterology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Rex', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Imperiale', 'Affiliation': ''}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001571']
122,34129127,Efficacy of a Modified Training Program of Adaptive Biofeedback Therapy for Dyssynergic Defecation in Patients with Chronic Constipation.,"BACKGROUND


Biofeedback therapy is highly effective and safe in treating dyssynergic defecation, which affects more than half of patients with chronic constipation. However, conventional biofeedback training has limitations.
AIMS


This study aims to modify the adaptive biofeedback (ABF) previously established by the investigators and evaluate its efficacy for dyssynergic defecation.
METHODS


A total of 42 constipation patients were enrolled and randomly assigned to receive either 4-week adaptive biofeedback (ABF) training (ABF group), or fixed biofeedback (FBF) training (FBF group). The ABF training program was modified, as follows: (1) the tailored training targets were set according to the ability of the individual subject, instead of the fixed values; (2) the outcome was scored on the basis of the rectal-anal pressure gradient; (3) the feedback information was delivered through multimedia. The outcomes were compared between the two groups.
RESULTS


The number of weekly bowel movements (BM) was significantly greater in the ABF group than in the FBF group. The improvement in dyssynergic defecation was also noted with the modified ABF training, which performed significantly better than the conventional training on incomplete defecation, bloating, defecation time, staining, and urgency. Notably, the use of medications was significantly reduced upon completion of the 4-week adaptive training, and this was significantly lesser than that in the fixed training. Furthermore, there was significantly better improvement on anorectal motility and rectal sensation in the ABF group vs. the FBF group.
CONCLUSION


The modified ABF training program significantly improves constipation-related symptoms, and its performance is superior to conventional FBF training for dyssynergic defecation.",2022,The number of weekly bowel movements (BM) was significantly greater in the ABF group than in the FBF group.,"['42 constipation patients', 'Patients with Chronic Constipation', 'patients with chronic constipation']","['Modified Training Program of Adaptive Biofeedback Therapy', 'conventional biofeedback training', 'adaptive biofeedback (ABF', 'ABF', 'Biofeedback therapy', 'conventional training', 'modified ABF training program', 'conventional FBF training', '4-week adaptive biofeedback (ABF) training (ABF group), or fixed biofeedback (FBF) training (FBF group']","['incomplete defecation, bloating, defecation time, staining, and urgency', 'constipation-related symptoms', 'dyssynergic defecation', 'number of weekly bowel movements (BM', 'anorectal motility and rectal sensation']","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0232718', 'cui_str': 'Anorectal motility'}, {'cui': 'C0232717', 'cui_str': 'Rectal sensation'}]",42.0,0.00543308,The number of weekly bowel movements (BM) was significantly greater in the ABF group than in the FBF group.,"[{'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, The Affiliated People's Hospital of Ningbo University, Ningbo, 315040, Zhejiang, China. xudaphne@126.com.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, The Affiliated People's Hospital of Ningbo University, Ningbo, 315040, Zhejiang, China.""}, {'ForeName': 'Feizhen', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': ""Department of Gastroenterology, The Affiliated People's Hospital of Ningbo University, Ningbo, 315040, Zhejiang, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, The Affiliated People's Hospital of Ningbo University, Ningbo, 315040, Zhejiang, China.""}, {'ForeName': 'Jiande D Z', 'Initials': 'JDZ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Michigan School of Medicine, Ann Arbor, MI, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-021-07094-z']
123,34125632,Pilot comparison of the ease of swallowing of single tablet antiretroviral regimens.,"Daily adherence to lifelong antiretroviral therapy (ART) is required to achieve long term treatment success. However, patient preferences for ART tablet size have not been well studied. Our study assessed factors associated with the ease of swallowing (EoS) and tolerability of two placebo tablets representing and matching B/F/TAF (BPT) and DTG/ABC/3TC (DPT). Fifty ART-naïve patients were randomized into a two-period cross-over study. Likert scale (1-5) questionnaires were administered to assess patient factors influencing the ease of swallowing, adherence, home medications, medication preferences and perceptions. Comparisons were done using Student  t -tests and ordinal regression. Participants were 64% female, 61% white, mean age 43 years, and taking a mean (median) of 4(1) pills/day. BPT was reported to be easier than DPT with ease of swallowability 1.76 vs. 2.42 ( p  < 0.001) (1 = very easy). DPT tablet was correctly perceived as larger than BPT ( p  < 0.001); with both tablets perceived as smaller than actual size ( p  < 0.001). EoS of either tablet was positively associated with the EoS of the largest home tablet medication ( p  = 0.021,  p  = 0.03). Patient's perceptions of EoS can affect their medication adherence, especially in HIV, and should be considered in treatment regimens.",2022,DPT tablet was correctly perceived as larger than BPT ( p  < 0.001); with both tablets perceived as smaller than actual size ( p  < 0.001).,"['Participants were 64% female, 61% white, mean age 43 years, and taking a mean (median) of 4(1) pills/day', 'Fifty ART-naïve patients']","['lifelong antiretroviral therapy (ART', 'BPT', 'placebo tablets representing and matching B/F/TAF (BPT) and DTG/ABC/3TC (DPT']","['ease of swallowing, adherence, home medications, medication preferences and perceptions', 'Likert scale', 'ease of swallowing (EoS) and tolerability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1613391', 'cui_str': 'lamivudine and abacavir'}, {'cui': 'C0636923', 'cui_str': 'diphenylthiosulfinate'}]","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0426604', 'cui_str': 'Ease of swallowing'}]",64.0,0.082225,DPT tablet was correctly perceived as larger than BPT ( p  < 0.001); with both tablets perceived as smaller than actual size ( p  < 0.001).,"[{'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Parraga Acosta', 'Affiliation': 'Medicine/Infectious Diseases Division, Henry Ford Hospital/Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Osborn', 'Affiliation': 'Medical School, Michigan State University, Detroit, MI, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Lee', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Haubrich', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McNicholl', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'McKinnon', 'Affiliation': 'Medicine/Infectious Diseases Division, Henry Ford Hospital/Wayne State University, Detroit, MI, USA.'}]",AIDS care,['10.1080/09540121.2021.1939258']
124,34146100,Three Dose Levels of a Maternal Respiratory Syncytial Virus Vaccine Candidate Are Well Tolerated and Immunogenic in a Randomized Trial in Nonpregnant Women.,"BACKGROUND


Respiratory syncytial virus (RSV) causes respiratory tract infections, which may require hospitalization especially in early infancy. Transplacental transfer of RSV antibodies could confer protection to infants in their first months of life.
METHODS


In this first-in-human, placebo-controlled study, 502 healthy nonpregnant women were randomized 1:1:1:1 to receive a single dose of unadjuvanted vaccine containing 30/60/120 µg of RSV fusion (F) protein stabilized in the prefusion conformation (RSVPreF3) or placebo.
RESULTS


Solicited local adverse events (AEs) were more frequently reported in the RSVPreF3 groups (4%-53.2%) versus placebo (0%-15.9%); most were mild/moderate. Unsolicited AEs were comparably reported among groups. Three serious AEs were reported; none was vaccination-related. Compared with prevaccination values, anti-RSV A neutralizing antibody geometric mean titers and anti-RSVPreF3 immunoglobulin G geometric mean concentrations increased 8- to 14-fold and 12- to 21-fold at day 8 and persisted 5- to 6-fold and 6- to 8-fold higher until day 91 in the RSVPreF3 groups versus 1-fold in placebo. Comparisons at day 8 and day 31 showed that the higher dose levels were significantly more immunogenic than the lowest one.
CONCLUSIONS


The RSVPreF3 vaccine was well tolerated and immunogenic. The 60 and 120 µg dose levels were selected for further investigation in pregnant women.
CLINICAL TRIALS REGISTRATION


NCT03674177.",2022,"Compared with pre-vaccination values, anti-RSV A neutralizing antibody geometric mean titers and anti-RSVPreF3 immunoglobulin G geometric mean concentrations increased 8-14-fold and 12-21-fold at day (D)8 and persisted 5-6-fold and 6-8-fold higher until D91 in the RSVPreF3 groups vs 1-fold in placebo.","['pregnant women', '502 healthy non-pregnant women', 'non-pregnant women']","['placebo', 'RSVPreF3 vaccine', 'unadjuvanted vaccine containing 30/60/120 µg of RSV fusion (F) protein stabilized in the prefusion conformation (RSVPreF3), or placebo']","['tolerated and immunogenic', 'neutralizing antibody geometric mean titers and anti-RSVPreF3 immunoglobulin G geometric mean concentrations', 'Solicited local adverse events (AEs']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}]","[{'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",502.0,0.384778,"Compared with pre-vaccination values, anti-RSV A neutralizing antibody geometric mean titers and anti-RSVPreF3 immunoglobulin G geometric mean concentrations increased 8-14-fold and 12-21-fold at day (D)8 and persisted 5-6-fold and 6-8-fold higher until D91 in the RSVPreF3 groups vs 1-fold in placebo.","[{'ForeName': 'Tino F', 'Initials': 'TF', 'LastName': 'Schwarz', 'Affiliation': 'Institute of Laboratory Medicine and Vaccination Centre, Klinikum Würzburg Mitte, Campus Juliusspital, Würzburg, Germany.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Johnson County Clin-Trials, Lenexa, Kansas, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Grigat', 'Affiliation': 'Clinical Research Hamburg, Hamburg, Germany.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL-Medi, Helsinki, Finland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Csonka', 'Affiliation': 'Centre for Child Health Research, Tampere University, Tampere, Finland.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Lindblad', 'Affiliation': 'Terveystalo Turku Vaccine Clinic, Turku, Finland.'}, {'ForeName': 'Thi Lien-Anh', 'Initials': 'TL', 'LastName': 'Nguyen', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Feng F', 'Initials': 'FF', 'LastName': 'Gao', 'Affiliation': 'GSK, Rockville, Maryland, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Qian', 'Affiliation': 'GSK, Rockville, Maryland, USA.'}, {'ForeName': 'Antonella N', 'Initials': 'AN', 'LastName': 'Tullio', 'Affiliation': 'GSK, Rockville, Maryland, USA.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Dieussaert', 'Affiliation': 'GSK, Rockville, Maryland, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Picciolato', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Ouzama', 'Initials': 'O', 'LastName': 'Henry', 'Affiliation': 'GSK, Rockville, Maryland, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiab317']
125,34129396,Cryotherapy Produces Pain Relief in Young People with Primary Dysmenorrhea.,"Primary dysmenorrhea is characterized as painful menstruation without associated pelvic disease and has been considered common among young people of reproductive age. Cryotherapy is a technique aimed at analgesia and anti-inflammatory action. The objective of this study was to analyze the analgesic efficacy of cryotherapy in sedentary youth with primary dysmenorrhea. Methods were included sedentary, affected by primary dysmenorrhea. The analysis of pain intensity by visual analog scale (VAS) and the Brazilian Version of the Wisconsin Brief Pain Questionnaire were used for evaluation. The participants were randomly separated into a control group (CG,  n  = 10) and a cryotherapy group (CryoG,  n  = 10). The evaluations and treatment occurred during a menstrual cycle, with three interventions, in the initial 3 days of higher menstrual flow history report. CG showed a reduction in pain when comparing the 1st with the 4th day of assessment; CryoG showed a daily reduction in VAS; for the pain questionnaire, cryotherapy showed a reduction in interference with sleep dysmenorrhea; and for all other variables, although there was no significant difference, a large effect size was observed. Cryotherapy was effective in reducing pain in women with primary dysmenorrhea, with indication of clinical improvement in daily living activities.",2022,"Cryotherapy was effective in reducing pain in women with primary dysmenorrhea, with indication of clinical improvement in daily living activities.","['sedentary youth with primary dysmenorrhea', 'Young People with Primary Dysmenorrhea', 'women with primary dysmenorrhea']","['CG', 'cryotherapy', 'Cryotherapy', 'control group (CG,  n \u2009=\u200910) and a cryotherapy group (CryoG,  n \u2009=\u200910']","['pain intensity by visual analog scale (VAS) and the Brazilian Version of the Wisconsin Brief Pain Questionnaire', 'analgesic efficacy', 'pain', 'daily reduction in VAS', 'Pain Relief', 'interference with sleep dysmenorrhea']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",,0.0442023,"Cryotherapy was effective in reducing pain in women with primary dysmenorrhea, with indication of clinical improvement in daily living activities.","[{'ForeName': 'Graziele Diniz', 'Initials': 'GD', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Therapy, Universidade Estadual do Oeste do Paraná (UNIOESTE), Cascavel, Brazil.'}, {'ForeName': 'Natyeli Alexsievena Henrichsen', 'Initials': 'NAH', 'LastName': 'Canova', 'Affiliation': 'Department of Physical Therapy, Universidade Estadual do Oeste do Paraná (UNIOESTE), Cascavel, Brazil.'}, {'ForeName': 'Polyana', 'Initials': 'P', 'LastName': 'Bortoletto', 'Affiliation': 'Department of Physical Therapy, Universidade Estadual do Oeste do Paraná (UNIOESTE), Cascavel, Brazil.'}, {'ForeName': 'Maria Luiza Serradourada', 'Initials': 'MLS', 'LastName': 'Wutzke', 'Affiliation': 'Bioscience and Health Posgraduate Program, Universidade Estadual do Oeste do Paraná (UNIOESTE), Cascavel, Brazil.'}, {'ForeName': 'Francyelle', 'Initials': 'F', 'LastName': 'Dos Santos Soares', 'Affiliation': 'Bioscience and Health Posgraduate Program, Universidade Estadual do Oeste do Paraná (UNIOESTE), Cascavel, Brazil.'}, {'ForeName': 'Gladson Ricardo Flor', 'Initials': 'GRF', 'LastName': 'Bertolini', 'Affiliation': 'Bioscience and Health Posgraduate Program, Universidade Estadual do Oeste do Paraná (UNIOESTE), Cascavel, Brazil.'}]",Therapeutic hypothermia and temperature management,['10.1089/ther.2021.0002']
126,34139041,A Canadian single institution real-world experience using the CROSS trial regimen in the treatment of oesophageal and gastroesophageal junction carcinoma.,"BACKGROUND


Trimodality therapy using the ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) trial protocol is an accepted standard of care for locally advanced oesophageal and gastroesophageal junction cancers. For medically inoperable patients, chemoradiotherapy (CRT) has been a therapeutic option.
AIMS


This single institution review aimed to assess the real-world application of the CROSS trial protocol.
METHODS


This is a retrospective review of 83 patients who underwent CRT with carboplatin and paclitaxel with trimodality or definitive intent between June 2012 and June 2018. Sixty-five patients underwent neoadjuvant CRT (NCRT); 40 had surgery, 18 had definitive CRT (DCRT). Patients' demographics, clinical, pathological, treatment and surgical characteristics were assessed. The data were analysed in exploratory analyses and Kaplan-Meier curves.
RESULTS


For 83 patients, the following median values were seen: radiotherapy dose, 50.4 Gy; chemotherapy doses, 5; and time from CRT to surgery, 62 days. Twenty-three percent NCRT and 72% DCRT patients were aged ≥75 years, and 49% and 33% of these respectively had no interruptions to CRT. Patients aged ≥75 years were more likely to have DCRT (P = 0.001). Patients who underwent surgery were younger (P = 0.04). For NCRT and surgery, NCRT only and DCRT respectively, median overall survival was 35.5, 12.1 and 17.1 months (log rank P = 0.008); progression-free survival was 32.2, 10 and 9.6 months (log rank P = 0.001).
CONCLUSIONS


Despite broadening of the CROSS trial eligibility criteria in our real-world data, there appears to be a survival benefit with trimodality therapy. The use of carboplatin and paclitaxel in DCRT may be of value and requires further study.",2021,"For NCRT and surgery, NCRT only, and DCRT respectively, median overall survival was 35.5, 12.1 and 17.1 months (log rank p=0.008); progression free survival was 32.2, 10 and 9.6 months (log rank p=0.001).
","['Esophageal and Gastroesophageal Junction Carcinoma', 'locally advanced esophageal and gastroesophageal junction cancers', '18 had definitive CRT (DCRT', '83 patients who underwent', 'with trimodality or definitive intent between June 2012 and June 2018', '65 patients underwent']","['chemoradiation (CRT', 'carboplatin and paclitaxel', 'neoadjuvant CRT (NCRT', 'CRT with carboplatin and paclitaxel']","['median overall survival', 'progression free survival']","[{'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",65.0,0.172094,"For NCRT and surgery, NCRT only, and DCRT respectively, median overall survival was 35.5, 12.1 and 17.1 months (log rank p=0.008); progression free survival was 32.2, 10 and 9.6 months (log rank p=0.001).
","[{'ForeName': 'Sidra', 'Initials': 'S', 'LastName': 'Khalid', 'Affiliation': ""Department of Medical Oncology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Wilma M', 'Initials': 'WM', 'LastName': 'Hopman', 'Affiliation': ""Department of Public Health Sciences, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Virik', 'Affiliation': ""Department of Medical Oncology, Queen's University, Kingston, Ontario, Canada.""}]",Internal medicine journal,['10.1111/imj.15427']
127,34229578,Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study.,"OBJECTIVES


This pilot study assessed clinical outcomes and quality care for persons with dementia in an acute hospital with PCC, compared with usual care.
METHODS


Forty-seven consented persons 60 years and over with dementia were assigned to PCC (n = 26) or usual care (control) (n = 21). Hospital nurses and allied health staff received 3 h of face-to-face education in PCC, and practice support by four PCC-trained nurse champions. Control group staff received 3 h of face-to-face education on dementia and delirium care clinical guidelines. Primary outcomes behavioral/neuropsychiatric symptoms and care quality were analyzed based on repeated measures at baseline (Time 1), 4-5 days after baseline (Time 2) and day 8-10 after baseline (Time 3) where available.
RESULTS


Compared with controls, at Time 2 PCC produced statistically significant improvements in behavioral/neuropsychiatric symptoms (adjusted  p  = .036) and care quality (adjusted  p  = .044). Where length of stay exceeded 8 days after baseline (Time 3), there was a sustained improvement in quality care ( p  = .007), but not in behavioral/neuropsychiatric symptoms ( p  = .27).
CONCLUSIONS


PCC can improve care quality for persons with dementia; nursing; agitation; paid caregivers with dementia and reduce behavioral/neuropsychiatric symptoms during short hospital stays.
CLINICAL IMPLICATIONS


Hospital systems need to support PCC to reduce behavioral/neuropsychiatric symptoms in dementia during long hospital stays.",2022,"Compared with controls, at Time 2 PCC produced statistically significant improvements in behavioral/neuropsychiatric symptoms (adjusted  p  = .036) and care quality (adjusted  p  = .044).","['persons with dementia in an acute hospital with PCC, compared with usual care', 'Forty-seven consented persons', 'Persons with Dementia in the Acute Care Setting', '60\xa0years and over with dementia']","['Person-centered Care', 'Control group staff received 3 h of face-to-face education', 'usual care (control', 'PCC']","['length of stay', 'care quality', 'behavioral/neuropsychiatric symptoms', 'behavioral/neuropsychiatric symptoms and care quality', 'quality care']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}]",47.0,0.0532737,"Compared with controls, at Time 2 PCC produced statistically significant improvements in behavioral/neuropsychiatric symptoms (adjusted  p  = .036) and care quality (adjusted  p  = .044).","[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Chenoweth', 'Affiliation': 'Centre for Healthy Brain Ageing, Faculty of Medicine, University of New South Wales (Sydney), Sydney, NSW, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'School of Nursing (Sydney), The University of Notre Dame Australia, Fremantle, NSW, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Fry', 'Affiliation': 'Northern Sydney Local Health District, Sydney; Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Endean', 'Affiliation': 'The Sutherland Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Stats Central, University of New South Wales (Sydney), Sydney, NSW, Australia.'}]",Clinical gerontologist,['10.1080/07317115.2021.1946233']
128,34182150,Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension.,"BACKGROUND & AIMS


We evaluated treatment withdrawal, long-term outcomes, and safety of budesonide oral suspension (BOS) 2.0 mg twice daily in patients with eosinophilic esophagitis who completed a 12-week induction study.
METHODS


Induction full responders (≤6 eosinophils per high-power field [eos/hpf] and ≥30% reduction in the Dysphagia Symptom Questionnaire score) to BOS 2.0 mg twice daily (ORBIT1/SHP621-301/NCT02605837) were randomized to continue BOS (BOS-BOS) or withdraw to placebo (BOS-PBO) for 36 weeks (ORBIT2/SHP621-302/NCT02736409). Induction partial responders and nonresponders, and patients who received induction placebo, received BOS for 36 weeks. The primary end point was the proportion of BOS-BOS and BOS-PBO patients who relapsed (≥15 eos/hpf and ≥4 days of dysphagia [Dysphagia Symptom Questionnaire] over 2 weeks) by week 36. The key secondary end point was the proportion of induction partial responders and nonresponders who fully responded after 52 weeks of total BOS therapy. Other secondary end points included the proportion of induction full responders with histologic responses (≤1, ≤6, <15 eos/hpf) at week 12 of the extension study, and safety outcomes.
RESULTS


The randomized withdrawal period enrolled 48 patients (BOS-BOS, n = 25; BOS-PBO, n = 23); 106 induction partial responders and nonresponders, and 65 induction placebo patients received BOS. More BOS-PBO than BOS-BOS patients relapsed over 36 weeks (43.5% vs 24.0%; P = .131) and had histologic responses at week 12 of therapy (P < .001). Overall, 13.2% of induction partial responders and nonresponders fully responded at week 36. BOS was well tolerated; therapy duration was not associated with new safety concerns.
CONCLUSIONS


For induction full responders, continuing BOS numerically improved maintenance of efficacy vs withdrawal. A longer therapy duration did not raise safety concerns. (ClinicalTrials.gov: NCT02736409.).",2022,"BOS was well-tolerated; therapy duration was not associated with new safety concerns.
","['Induction full responders (≤6 eosinophils per high-power field [eos/hpf', '48 patients (BOS-BOS, n=25; BOS-PBO, n=23); 106 induction partial- and non-responders and 65 induction', 'patients with eosinophilic esophagitis who completed a 12-week induction study']","['Budesonide Oral Suspension', 'induction placebo', 'budesonide oral suspension (BOS', 'continue BOS (BOS-BOS) or withdraw to placebo', 'placebo patients received BOS']","['safety outcomes', 'histologic responses', 'Dysphagia Symptom Questionnaire [DSQ] score', ""proportion of induction partial- and non-responders who fully responded after 52 weeks' total BOS therapy"", 'proportion of BOS-BOS and BOS-PBO patients who relapsed', 'proportion of induction full responders with histologic responses']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0439530', 'cui_str': '/HPF'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0592459', 'cui_str': 'Budesonide-containing product in oral dose form'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0592459', 'cui_str': 'Budesonide-containing product in oral dose form'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0592459', 'cui_str': 'Budesonide-containing product in oral dose form'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",48.0,0.110792,"BOS was well-tolerated; therapy duration was not associated with new safety concerns.
","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: evan_dellon@med.unc.edu.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Katzka', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'Mukkada', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Falk', 'Affiliation': 'Division of Gastroenterology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Morey', 'Affiliation': 'Takeda Development Center Americas, Inc, Lexington, Massachusetts.'}, {'ForeName': 'Bridgett', 'Initials': 'B', 'LastName': 'Goodwin', 'Affiliation': 'Takeda Development Center Americas, Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Eisner', 'Affiliation': 'Takeda Pharmaceuticals USA, Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Takeda Development Center Americas, Inc, Lexington, Massachusetts.'}, {'ForeName': 'Nirav K', 'Initials': 'NK', 'LastName': 'Desai', 'Affiliation': 'Takeda Development Center Americas, Inc, Cambridge, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Takeda Development Center Americas, Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2021.06.020']
129,34193981,Infographic: the Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT).,,2022,,[],['Pneumatic Retinopexy versus Vitrectomy'],[],[],"[{'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]",[],,0.0883927,,"[{'ForeName': 'Declan C', 'Initials': 'DC', 'LastName': 'Murphy', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Tzoumas', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Islam', 'Initials': 'I', 'LastName': 'Mostafa', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Salman N', 'Initials': 'SN', 'LastName': 'Sadiq', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Song', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Al-Zubaidy', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ali E', 'Initials': 'AE', 'LastName': 'Ghareeb', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Steel', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK. david.steel@ncl.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-021-01597-9']
130,34224510,Oral Is as Effective as Intravenous Tranexamic Acid at Reducing Blood Loss in Thoracolumbar Spinal Fusions: A Prospective Randomized Trial.,"STUDY DESIGN


A prospective randomized trial at a university affiliated tertiary medical center between February 2017 and March 2020.
OBJECTIVE


The aim of this study was to compare perioperative blood loss in patients undergoing elective posterior thoracolumbar fusion who were treated with IV versus PO TXA.
SUMMARY OF BACKGROUND DATA


The use of antifibrinolytic agents such as tranexamic acid (TXA) to decrease operative blood loss and allogenic blood transfusions is well documented in the literature. Although evidence supports the use of intravenous (IV) and topical formulations of TXA in spine surgery, the use of oral (PO) TXA has not been studied.
METHODS


A total of 261 patients undergoing thoracolumbar fusion were randomized to receive 1.95 g of PO TXA 2 hours preoperatively or 2 g IV TXA (1 g before incision and 1 g before wound closure) intraoperatively. The sample was further stratified into three categories based on number of levels fused (one-to two-level fusions, three to five, and more than five). The primary outcome was the reduction of hemoglobin. Secondary outcomes included calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay. Equivalence analysis was performed with a two one-sided test.
RESULTS


One hundred thirty-seven patients received IV and 124 received PO TXA. The average age was 62 ± 13 years (mean ± SD), including 141 females and 120 males. Revision cases comprised of 67% of the total sample. Patient demographic factors were similar between groups except for weight, BMI, and preoperative platelet count. The mean reduction of hemoglobin was similar between IV and PO groups (3.56 vs. 3.28 g/dL, respectively; P = 0.002, equivalence). IV TXA group had a higher transfusion rate compared to PO TXA group (22 patients [19%] vs. 12 patients [10%]; P = 0.03). In addition, IV group had longer length of stay (LOS) than PO group (4.4 vs. 3.7 days; P = 0.02).
CONCLUSION


Patients treated with IV and PO TXA experienced the same perioperative blood loss after small and large spinal fusions. In subgroup analysis, the intermediate (three to five level) spinal fusions had less blood loss with PO TXA than IV TXA. Given its lower cost, PO TXA represents a superior alternative to IV TXA in patients undergoing elective posterior thoracolumbar fusion and may improve health care cost-efficiency in the studied population.Level of Evidence: 1.",2022,"In subgroup analysis, the intermediate (3-5 level) spinal fusions had less blood loss with PO TXA than IV TXA.","['Thoracolumbar Spinal Fusions', 'patients undergoing elective posterior thoracolumbar fusion', 'patients undergoing elective posterior thoracolumbar fusion who were treated with IV versus PO TXA', 'university affiliated tertiary medical center between February 2017 and March 2020', '261 patients undergoing thoracolumbar fusion', 'The average age was 62\u200a±\u200a13\u200ayears (Mean\u200a±\u200aSD), including 141 females and 120 males', '137 patients received IV and 124 received']","['oral (PO) TXA', 'IV TXA', 'PO TXA 2\u200ahours preoperatively or 2', 'Tranexamic Acid', 'g IV TXA', 'IV and PO TXA', 'TXA', 'tranexamic acid (TXA', 'PO TXA']","['Blood Loss', 'reduction of hemoglobin', 'Level of Evidence', 'mean reduction of hemoglobin', 'calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay', 'operative blood loss and allogenic blood transfusions', 'healthcare cost-efficiency', 'longer length of stay (LOS', 'transfusion rate', 'blood loss', 'perioperative blood loss']","[{'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1292425', 'cui_str': '2 hours'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3160876', 'cui_str': 'Allogenic blood transfusion'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",261.0,0.0844415,"In subgroup analysis, the intermediate (3-5 level) spinal fusions had less blood loss with PO TXA than IV TXA.","[{'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Yu', 'Affiliation': 'Norton Leatherman Spine Center, Louisville, KY.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Fidai', 'Affiliation': 'Department of Orthopedic Surgery, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Washington', 'Affiliation': 'Department of Orthopedic Surgery, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bartol', 'Affiliation': 'Department of Orthopedic Surgery, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Graziano', 'Affiliation': 'Department of Orthopedic Surgery, Henry Ford Health System, Detroit, MI.'}]",Spine,['10.1097/BRS.0000000000004157']
131,34147344,"Efficacy of individualized homeopathic medicines in intervening with the progression of pre-hypertension to hypertension: A double-blind, randomized, placebo-controlled trial.","CONTEXT


Pre-hypertension remains a significant public health challenge and appropriate intervention is required to stop its progression to hypertension and/or cardiovascular diseases.
OBJECTIVE


To study the effects of individualized homeopathic medicines (IH) against placebo in intervening with the progression of pre-hypertension to hypertension.
DESIGN


Double-blind, randomized, two parallel arms, placebo-controlled trial.
SETTING


Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
PATIENTS


Ninety-two patients suffering from pre-hypertension; randomized to receive either IH (n = 46) or identical-looking placebo (n = 46).
INTERVENTIONS


IH or placebo in the mutual context of lifestyle modification (LSM) advices including dietary approaches to stop hypertension (DASH) and brisk exercises.
MAIN OUTCOME MEASURES


Primary - systolic and diastolic blood pressure (SBP and DBP); secondary - Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2) scores; all measured at baseline, and every month, up to 3 months.
RESULTS


After 3 months of intervention, the number of patients having progression from pre-hypertension to hypertension between groups were similar without any significant differences in between (all P>0.05). Reduction in BP and MYMOP-2 scores were non-significantly higher (all P>0.05) in the IH group than placebo with small effect sizes. Lycopodium clavatum, Thuja occidentalis and Natrum muriaticum were the most frequently prescribed medicines. No harms or serious adverse events were reported from either group. Thus, there was a small, but non-significant direction of effect favoring homeopathy, which ultimately rendered the trial as inconclusive. [Trial registration: CTRI/2018/10/016,026; UTN: U1111-1221-8251].",2022,Reduction in BP and MYMOP-2 scores were non-significantly higher (all P>0.05) in the IH group than placebo with small effect sizes.,"['Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India', 'pre-hypertension to hypertension', 'Ninety-two patients suffering from pre-hypertension']","['IH or placebo', 'placebo', 'individualized homeopathic medicines (IH) against placebo', 'IH (n\xa0=\xa046) or identical-looking placebo', 'individualized homeopathic medicines']","['Lycopodium clavatum, Thuja occidentalis and Natrum muriaticum', 'Reduction in BP and MYMOP-2 scores', 'No harms or serious adverse events', 'systolic and diastolic blood pressure (SBP and DBP', 'number of patients having progression from pre-hypertension to hypertension', 'secondary - Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2) scores']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0444826', 'cui_str': 'Bengal'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0937638', 'cui_str': 'Lycopodium Clavatum Preparation'}, {'cui': 'C0993604', 'cui_str': 'Arbor Vitae'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.409887,Reduction in BP and MYMOP-2 scores were non-significantly higher (all P>0.05) in the IH group than placebo with small effect sizes.,"[{'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Dept. of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India. Electronic address: drsouvikdutta@gmail.com.'}, {'ForeName': 'Subhasish', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'Dept. of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.'}, {'ForeName': 'Shyamal Kumar', 'Initials': 'SK', 'LastName': 'Mukherjee', 'Affiliation': 'Principal and Administrator D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Ghosh', 'Affiliation': 'Dept. of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Hazra', 'Affiliation': 'Dept. of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.'}, {'ForeName': 'Aniket Singha', 'Initials': 'AS', 'LastName': 'Roy', 'Affiliation': 'Dept. of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.'}, {'ForeName': 'Abdur Rahaman', 'Initials': 'AR', 'LastName': 'Shaikh', 'Affiliation': 'Dept. of Practice of Medicine, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.'}, {'ForeName': 'Sk Swaif', 'Initials': 'SS', 'LastName': 'Ali', 'Affiliation': 'Dept. of Practice of Medicine, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, Govt. of West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.'}, {'ForeName': 'Satarupa', 'Initials': 'S', 'LastName': 'Sadhukhan', 'Affiliation': 'Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India; affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.'}, {'ForeName': 'Munmun', 'Initials': 'M', 'LastName': 'Koley', 'Affiliation': 'Dept. of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, Lucknow, Govt. of Uttar Pradesh, affiliated to Dr. Bhimrao Ramji Ambedkar University, Agra, Govt. of Uttar Pradesh), India.'}, {'ForeName': 'Subhranil', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Dept. of Repertory, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.05.007']
132,34210681,"Standard-Dose Pembrolizumab Plus Alternate-Dose Ipilimumab in Advanced Melanoma: KEYNOTE-029 Cohort 1C, a Phase 2 Randomized Study of Two Dosing Schedules.","PURPOSE


Standard-dose pembrolizumab plus alternative-dose ipilimumab (1 mg/kg Q3W for 4 doses) were tolerable and had robust antitumor activity in advanced melanoma in cohort B of the phase 1 KEYNOTE-029 study. Cohort C evaluated standard-dose pembrolizumab with two other alternative ipilimumab regimens.
PATIENTS AND METHODS


Patients with treatment-naive unresectable stage III/IV melanoma were randomly assigned 1:1 to pembrolizumab 200 mg Q3W for ≤24 months plus ipilimumab 50 mg Q6W for 4 doses (PEM200+IPI50), or the same pembrolizumab regimen plus ipilimumab 100 mg Q12W for 4 doses (PEM200+IPI100). Primary end points were incidence of grade 3-5 treatment-related adverse events (TRAE) and objective response rate (ORR) per RECIST v1.1 by independent central review. Per protocol-defined thresholds, grade 3-5 TRAE incidence ≤26% indicated meaningful toxicity reduction and ORR ≥48% indicated no decrease in efficacy versus data reported for other PD-1 inhibitor/ipilimumab combinations.
RESULTS


Median follow-up on February 18, 2019, was 16.3 months in PEM200+IPI50 (N = 51) and 16.4 months in PEM200+IPI100 (N = 51). Grade 3-5 TRAEs occurred in 12 (24%) patients in PEM200+IPI50 and 20 (39%) in PEM200+IPI100. One patient in PEM200+IPI50 died from treatment-related autoimmune myocarditis. Immune-mediated AEs or infusion reactions occurred in 21 (42%) patients in PEM200+IPI50 and 28 (55%) in PEM200+IPI100. ORR was 55% in PEM200+IPI50; 61% in PEM200+IPI100.
CONCLUSIONS


Pembrolizumab 200 mg Q3W plus ipilimumab 50 mg Q6W or 100 mg Q12W demonstrated antitumor activity above the predefined threshold; pembrolizumab plus ipilimumab 50 mg Q6W had lower incidence of grade 3-5 TRAEs than the predefined threshold, suggesting a reduction in toxicity. See related commentary by Jameson-Lee and Luke, p. 5153.",2021,Immune-mediated AEs or infusion reactions occurred in 21 (42%) patients in PEM200+IPI50 and 28 (55%) in PEM200+IPI100.,"['Patients with treatment-naive unresectable stage III/IV melanoma', 'Advanced Melanoma']","['PEM200+IPI100', 'pembrolizumab 200 mg Q3W for {less than or equal to}24 months plus ipilimumab 50 mg Q6W for 4 doses (PEM200+IPI50), or the same pembrolizumab regimen plus ipilimumab 100 mg Q12W for 4 doses (PEM200+IPI100', 'Pembrolizumab Plus Alternate-Dose Ipilimumab', 'Pembrolizumab 200 mg Q3W plus ipilimumab', 'pembrolizumab plus alternative-dose ipilimumab']","['Grade 3-5 TRAEs', 'Immune-mediated AEs or infusion reactions', 'toxicity', 'antitumor activity', 'meaningful toxicity reduction and ORR ', 'incidence of grade 3-5 treatment-related adverse events (TRAEs) and objective response rate (ORR) per RECIST v1.1 by independent central review', 'ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction to drug or medicament administered by infusion'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",,0.0869439,Immune-mediated AEs or infusion reactions occurred in 21 (42%) patients in PEM200+IPI50 and 28 (55%) in PEM200+IPI100.,"[{'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Department of Medical Oncology and Translational Research, Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, New South Wales, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Medicine, Dermatology Service, Gustave Roussy, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Butler', 'Affiliation': 'Department of Medical Oncology, The Princess Margaret Cancer Center and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Couture', 'Affiliation': 'Department of Hematology, CHU de Québec-Hôtel-Dieu de Québec, Québec City, Québec, Canada.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Department of Medicine, Westmead and Blacktown Hospitals, Melanoma Institute Australia, and The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': ""O'Day"", 'Affiliation': ""Department of Medical Oncology, John Wayne Cancer Institute at Providence Saint John's Health Center, Santa Monica, California.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'University of Queensland, Division of Cancer Sciences, Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Cebon', 'Affiliation': 'Department of Hematology/Oncology, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Brown', 'Affiliation': 'Cancer Clinical Trials Unit, Royal Adelaide Hospital and University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'University of Lyon, Hospices Civils de Lyon, Cancer Research Center of Lyon, Lyon, France.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Hill', 'Affiliation': 'Department of Health, Tasman Oncology Research, Southport, Queensland, Australia.'}, {'ForeName': 'Geoffrey T', 'Initials': 'GT', 'LastName': 'Gibney', 'Affiliation': 'Melanoma Disease Group, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McCune', 'Affiliation': 'Department of Clinical Research, Wellstar Health System, Marietta, Georgia.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Menzies', 'Affiliation': 'Department of Medical Oncology and Translational Research, Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, New South Wales, Australia.'}, {'ForeName': 'Cuizhen', 'Initials': 'C', 'LastName': 'Niu', 'Affiliation': 'Department of Clinical Oncology, MSD China, Beijing, China.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Blanca Homet', 'Initials': 'BH', 'LastName': 'Moreno', 'Affiliation': 'Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Diab', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-0793']
133,34312316,A telerehabilitation programme in post-discharge COVID-19 patients (TERECO): a randomised controlled trial.,"OBJECTIVES


To investigate superiority of a telerehabilitation programme for COVID-19 (TERECO) over no rehabilitation with regard to exercise capacity, lower limb muscle strength (LMS), pulmonary function, health-related quality of life (HRQOL) and dyspnoea.
DESIGN


Parallel-group randomised controlled trial with 1:1 block randomisation.
SETTING


Three major hospitals from Jiangsu and Hubei provinces, China.
PARTICIPANTS


120 formerly hospitalised COVID-19 survivors with remaining dyspnoea complaints were randomised with 61 allocated to control and 59 to TERECO.
INTERVENTION


Unsupervised home-based 6-week exercise programme comprising breathing control and thoracic expansion, aerobic exercise and LMS exercise, delivered via smartphone, and remotely monitored with heart rate telemetry.
OUTCOMES


Primary outcome was 6 min walking distance (6MWD) in metres. Secondary outcomes were squat time in seconds; pulmonary function assessed by spirometry; HRQOL measured with Short Form Health Survey-12 (SF-12) and mMRC-dyspnoea. Outcomes were assessed at 6 weeks (post-treatment) and 28 weeks (follow-up).
RESULTS


Adjusted between-group difference in change in 6MWD was 65.45 m (95% CI 43.8 to 87.1; p<0.001) at post-treatment and 68.62 m (95% CI 46.39 to 90.85; p<0.001) at follow-up. Treatment effects for LMS were 20.12 s (95% CI 12.34 to 27.9; p<0.001) post-treatment and 22.23 s (95% CI 14.24 to 30.21; p<0.001) at follow-up. No group differences were found for lung function except post-treatment maximum voluntary ventilation. Increase in SF-12 physical component was greater in the TERECO group with treatment effects estimated as 3.79 (95% CI 1.24 to 6.35; p=0.004) at post-treatment and 2.69 (95% CI 0.06 to 5.32; p=0.045) at follow-up.
CONCLUSIONS


This trial demonstrated superiority of TERECO over no rehabilitation for 6MWD, LMS, and physical HRQOL.
TRIAL REGISTRATION NUMBER


ChiCTR2000031834.",2022,"Increase in SF-12 physical component was greater in the TERECO group with treatment effects estimated as 3.79 (95% CI 1.24 to 6.35; p=0.004) at post-treatment and 2.69 (95% CI 0.06 to 5.32; p=0.045) at follow-up.
","['Three major hospitals from Jiangsu and Hubei provinces, China', 'post-discharge COVID-19 patients (TERECO', '120 formerly hospitalised COVID-19 survivors with remaining dyspnoea complaints']","['telerehabilitation programme for COVID-19 (TERECO', 'Unsupervised home-based 6-week exercise programme comprising breathing control and thoracic expansion, aerobic exercise and LMS exercise, delivered via smartphone, and remotely monitored with heart rate telemetry', 'LMS', 'TERECO']","['lung function except post-treatment maximum voluntary ventilation', '6\u2009min walking distance (6MWD) in metres', 'change in 6MWD', 'limb muscle strength (LMS), pulmonary function, health-related quality of life (HRQOL) and dyspnoea', 'SF-12 physical component', 'squat time in seconds; pulmonary function assessed by spirometry; HRQOL measured with Short Form Health Survey-12 (SF-12) and mMRC-dyspnoea']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0419118', 'cui_str': 'Muscle strength exercise'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039451', 'cui_str': 'Telemetry'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024967', 'cui_str': 'Maximum voluntary ventilation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",120.0,0.147666,"Increase in SF-12 physical component was greater in the TERECO group with treatment effects estimated as 3.79 (95% CI 1.24 to 6.35; p=0.004) at post-treatment and 2.69 (95% CI 0.06 to 5.32; p=0.045) at follow-up.
","[{'ForeName': ""Jian'an"", 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Center for Rehabilitation Medicine, Jiangsu Province Hospital/Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu, People's Republic of China.""}, {'ForeName': 'Wenguang', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': ""Department of Rehabilitation Medicine, Hubei Province Hospital of Integrated Chinese and Western Medicine, Wuhan, Hubei, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhan', 'Affiliation': ""Department of Rehabilitation Medicine, Huangshi Traditional Chinese Medicine Hospital, Huangshi, Hubei, People's Republic of China.""}, {'ForeName': 'Shouguo', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Center for Rehabilitation Medicine, Jiangsu Province Hospital/Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhifei', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': ""Center for Rehabilitation Medicine, Jiangsu Province Hospital/Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu, People's Republic of China.""}, {'ForeName': 'Jiayue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Center for Rehabilitation Medicine, Jiangsu Province Hospital/Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Chong', 'Affiliation': ""Department of Rehabilitation Medicine, Hubei Province Hospital of Integrated Chinese and Western Medicine, Wuhan, Hubei, People's Republic of China.""}, {'ForeName': 'Chanjuan', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ""Department of Rehabilitation Medicine, Hubei Province Hospital of Integrated Chinese and Western Medicine, Wuhan, Hubei, People's Republic of China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': ""Department of Rehabilitation Medicine, Huangshi Traditional Chinese Medicine Hospital, Huangshi, Hubei, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': ""Department of Rehabilitation Medicine, Huangshi Traditional Chinese Medicine Hospital, Huangshi, Hubei, People's Republic of China.""}, {'ForeName': 'Jan D', 'Initials': 'JD', 'LastName': 'Reinhardt', 'Affiliation': ""Institute for Disaster Management and Reconstruction, Sichuan University, Chengdu, Sichuan, People's Republic of China jan.reinhardt@paraplegie.ch.""}]",Thorax,['10.1136/thoraxjnl-2021-217382']
134,34301454,Aerobic exercise and cognitive functioning in schizophrenia: Findings of dose-response analysis from a pilot randomized controlled trial.,,2022,,['schizophrenia'],['Aerobic exercise and cognitive functioning'],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",[],,0.23964,,"[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Shimada', 'Affiliation': 'Department of Rehabilitation, Medical Corporation Seitaikai, Mental Support Soyokaze Hospital, Nagano, Japan. Electronic address: ot@seitaikai.or.jp.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Rehabilitation, Medical Corporation Seitaikai, Mental Support Soyokaze Hospital, Nagano, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Makabe', 'Affiliation': 'Department of Rehabilitation, Medical Corporation Seitaikai, Mental Support Soyokaze Hospital, Nagano, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Yamanushi', 'Affiliation': 'Department of Rehabilitation, Medical Corporation Seitaikai, Mental Support Soyokaze Hospital, Nagano, Japan.'}, {'ForeName': 'Sonoko', 'Initials': 'S', 'LastName': 'Miyasaka', 'Affiliation': 'Department of Rehabilitation, Medical Corporation Seitaikai, Mental Support Soyokaze Hospital, Nagano, Japan.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Takenaka', 'Affiliation': 'Department of Rehabilitation, Medical Corporation Seitaikai, Mental Support Soyokaze Hospital, Nagano, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Kawano', 'Affiliation': 'Department of Rehabilitation, Medical Corparation Yuaikai Tikumaso Mental Hospital, Nagano, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Health Sciences, Graduate School of Medicine, Shinshu University, Nagano, Japan.'}]",Schizophrenia research,['10.1016/j.schres.2021.07.015']
135,34259904,Perfusion Changes in Acute Stroke Treated with Theophylline as an Add-on to Thrombolysis : A Randomized Clinical Trial Subgroup Analysis.,"PURPOSE


Theophylline has been suggested to have a neuroprotective effect in ischemic stroke; however, results from animal stroke models and clinical trials in humans are controversial. The aim of this study was to assess the effect of theophylline on the cerebral perfusion with multiparametric magnetic resonance imaging (MRI).
METHODS


The relative cerebral blood flow (rCBF), relative cerebral blood volume (rCBV), and relative mean transit time (rMTT) in the infarct core, penumbra, and unaffected tissue were measured using multi-parametric MRI at baseline and 3‑h follow-up in patients treated with theophylline or placebo as an add-on to thrombolytic therapy.
RESULTS


No significant differences in mean rCBF, rCBV, and rMTT was found in the penumbra and unaffected tissue between the theophylline group and the control group between baseline and 3‑h follow-up. In the infarct core, mean rCBV increased on average by 0.05 in the theophylline group and decreased by 0.14 in the control group (p < 0.04). Mean rCBF and mean rMTT in the infarct core were similar between the two treatment groups.
CONCLUSION


The results indicate that theophylline does not change the perfusion in potentially salvageable penumbral tissue but only affects the rCBV in the infarct core. In contrast to the penumbra, the infarct core is unlikely to be salvageable, which might explain why theophylline failed in clinical trials.",2022,"No significant differences in mean rCBF, rCBV, and rMTT was found in the penumbra and unaffected tissue between the theophylline group and the control group between baseline and 3‑h follow-up.",[],"['Thrombolysis ', 'theophylline', 'theophylline or placebo', 'Theophylline', 'multiparametric magnetic resonance imaging (MRI']","['mean rCBF, rCBV, and rMTT', 'relative cerebral blood flow (rCBF), relative cerebral blood volume (rCBV), and relative mean transit time (rMTT) in the infarct core, penumbra, and unaffected tissue', 'mean rCBV', 'Mean rCBF and mean rMTT']",[],"[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C4277714', 'cui_str': 'Cerebral Blood Volume'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",,0.0873819,"No significant differences in mean rCBF, rCBV, and rMTT was found in the penumbra and unaffected tissue between the theophylline group and the control group between baseline and 3‑h follow-up.","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Modrau', 'Affiliation': 'Department of Neurology, Aalborg University Hospital, Postbox 561, 9100, Aalborg, Denmark. boris.modrau@rn.dk.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Winder', 'Affiliation': 'Departments of Radiology & Clinical Neurosciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hjort', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Nygård Johansen', 'Affiliation': 'Unit of Clinical Biostatistics, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Department of Neurology and Clinical Medicine, Aarhus University Hospital, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Fiehler', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Vorum', 'Affiliation': 'Department of Ophthalmology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Nils D', 'Initials': 'ND', 'LastName': 'Forkert', 'Affiliation': 'Departments of Radiology & Clinical Neurosciences, University of Calgary, Calgary, Canada.'}]",Clinical neuroradiology,['10.1007/s00062-021-01029-x']
136,34305615,Effect of a Topical Nonsteroidal Anti-Inflammatory Drug (0.1% Pranoprofen) on VEGF and COX-2 Expression in Primary Pterygium.,"Purpose:  To evaluate the effect of a topical nonsteroidal anti-inflammatory drug (0.1% pranoprofen) on the expression of VEGF and Cox-2 in primary pterygium.  Methods:  This was a prospective, randomized study. Between January 2019 and April 2020, 120 patients diagnosed with primary pterygium were enrolled and randomly divided into three groups before operation: 1) 40 patients in group 1 received topical pranoprofen 0.1% four times daily for 4 weeks, 2) 40 patients in group 2 received topical fluorometholone 0.1% four times daily for 4 weeks, and 3) patients in group 3 did not receive treatment. For each group, the age, sex, eye type, best-corrected visual acuity (BCVA), intraocular pressure (IOP), duration of onset, combined systemic diseases, and the results regarding vascular endothelial growth factor (VEGF) and cyclo-oxygen-ase-2 (COX-2) in postoperative pterygial tissues were evaluated in detail.  Results:  There were no significant differences regarding age, sex, eye type, combined systemic diseases, duration of onset, IOP, and BCVA within the three groups ( p  > 0.05). The reduction of VEGF and CoX-2 expression of pterygial vascular endothelial cells in group 1 were statistically significant compared to group 2 and group 3 ( p  < 0.05). There were significant correlations between COX-2 and VEGF expression of pterygial tissues within the three groups ( p  < 0.05).  Conclusion:  The present findings suggested that the topical pranoprofen 0.1% could reduce the expression of VEGF and COX-2 in primary pterygium. We confirmed that treatment with pranoprofen offers advantages in early intervention and has therapeutic potential in reducing the postoperative recurrence of primary pterygium patients.  Clinical Trial registration : The study was registered with the Chinese Clinical Trial Registry. (http://www.chictr.org.cn/index.aspx, Registration Number: ChiCTR2100047726).",2021,The reduction of VEGF and CoX-2 expression of pterygial vascular endothelial cells in group 1 were statistically significant compared to group 2 and group 3 ( p  < 0.05).,"['primary pterygium patients', 'primary pterygium', 'Primary Pterygium', 'Between January 2019 and April 2020, 120 patients diagnosed with primary pterygium']","['topical nonsteroidal anti-inflammatory drug (0.1% pranoprofen', 'topical pranoprofen', 'Topical Nonsteroidal Anti-Inflammatory Drug (0.1% Pranoprofen', 'pranoprofen', 'topical fluorometholone 0.1% four times daily for 4\xa0weeks, and 3) patients in group 3 did not receive treatment']","['vascular endothelial growth factor (VEGF) and cyclo-oxygen-ase-2 (COX-2', 'VEGF and COX-2 Expression', 'age, sex, eye type, combined systemic diseases, duration of onset, IOP, and BCVA', 'reduction of VEGF and CoX-2 expression of pterygial vascular endothelial cells', 'COX-2 and VEGF expression of pterygial tissues', 'visual acuity (BCVA), intraocular pressure (IOP), duration of onset, combined systemic diseases', 'expression of VEGF and COX-2']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0072652', 'cui_str': 'pranoprofen'}, {'cui': 'C0016351', 'cui_str': 'Fluorometholone'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1257792', 'cui_str': 'Vascular Endothelial Cells'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",120.0,0.0490869,The reduction of VEGF and CoX-2 expression of pterygial vascular endothelial cells in group 1 were statistically significant compared to group 2 and group 3 ( p  < 0.05).,"[{'ForeName': 'Bangtao', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': ""Department of Ophthalmology, Nanjing Lishui District People's Hospital, Lishui Branch of Southeast University Affiliated Zhongda Hospital, Nanjing, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaogui', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Ophthalmology, Nanjing Lishui District People's Hospital, Lishui Branch of Southeast University Affiliated Zhongda Hospital, Nanjing, China.""}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Nanjing Lishui District People's Hospital, Lishui Branch of Southeast University Affiliated Zhongda Hospital, Nanjing, China.""}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Yue', 'Affiliation': ""Department of Pathology, Nanjing Lishui District People's Hospital, Lishui Branch of Southeast University Affiliated Zhongda Hospital, Nanjing, China.""}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Ophthalmology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Nanjing Lishui District People's Hospital, Lishui Branch of Southeast University Affiliated Zhongda Hospital, Nanjing, China.""}]",Frontiers in pharmacology,['10.3389/fphar.2021.709251']
137,34318542,The effect of nurse-led telephone support on adherence to blood pressure control and drug treatment in individuals with primary hypertension: A randomized controlled study.,"AIM


The aim of this study was to evaluate the effect of telephone monitoring, in combination with texts, on medication adherence and blood pressure (BP) control in primary hypertension.
METHOD


Data were collected from August to December 2016. Seventy-seven adults were randomized to the intervention and control groups. A 12-week intervention consisted of regular text messages and phone calls. The control group received usual hypertension care. The outcomes were evaluated with blood pressure measurement and medication adherence self-efficacy scale short form.
RESULTS


Medication adherence in Week 12 was found to be significantly higher in the intervention group than in the control group. Mean systolic and diastolic BP levels in Weeks 4, 8 and 12 were statistically significantly lower in the intervention group than in the control group (p < 0.05).
CONCLUSION


Using text messaging and nurse-led telephone monitoring improved adherence and BP control in adults with hypertensive in primary care.",2022,"Mean systolic and diastolic BP levels in Weeks 4, 8 and 12 were statistically significantly lower in the intervention group than in the control group (p < 0.05).
","['adults with hypertensive in primary care', 'primary hypertension', 'Data were collected from August to December 2016', 'individuals with primary hypertension', 'Seventy-seven adults']","['usual hypertension care', 'nurse-led telephone support', 'text messaging and nurse-led telephone monitoring', 'regular text messages and phone calls']","['Mean systolic and diastolic BP levels', 'blood pressure measurement and medication adherence self-efficacy scale short form', 'medication adherence and blood pressure (BP) control', 'Medication adherence', 'adherence and BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",77.0,0.0123817,"Mean systolic and diastolic BP levels in Weeks 4, 8 and 12 were statistically significantly lower in the intervention group than in the control group (p < 0.05).
","[{'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Kes', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Karabuk University, Karabük, Turkey.'}, {'ForeName': 'Ulku', 'Initials': 'U', 'LastName': 'Polat', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Gazi University, Ankara, Turkey.'}]",International journal of nursing practice,['10.1111/ijn.12995']
138,33910778,Effects of short-term Huatou Chan training on health.,"Previous studies have shown that perennial Chan training leads to improvements in brain functioning. However, few studies have investigated the effects of short-term Huatou Chan training. The current study explored the effects of a three-day Huatou Chan training on physical and emotional health, as well as brain state. Seventy healthy subjects were recruited and divided into two groups: the Huatou Chan group and the Control group. The Huatou Chan group received a 3-day Huatou Chan training, while the Control group waited for three days. Both groups completed a 6 min Brain State Index recording, the SCL-90, the brief profile of mood state, the meaning in life questionnaire, and the Index of Well-being, prior to and after the training or waiting period. Results showed that short-term Huatou Chan training had significant benefits on some aspects such as physical and emotional health (obsessive-compulsive, depression, hostility, and psychoticism), negative emotions (tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, and confusion-bewilderment), well-being, and attitude towards life. In addition, short-term Chan training can significantly improve brain state, as shown by the index of depression, anxiety, alerting and intelligence. This is the first study to provide direct evidence for the benefits of short-term intensive Huatou Chan training on physical and mental health.",2022,"Results showed that short-term Huatou Chan training had significant benefits on some aspects such as physical and emotional health (obsessive-compulsive, depression, hostility, and psychoticism), negative emotions (tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, and confusion-bewilderment), well-being, and attitude towards life.",['Seventy healthy subjects'],"['short-term Huatou Chan training', 'intensive Huatou Chan training', 'perennial Chan training', 'Huatou Chan training', 'Huatou Chan group and the Control group', '3-day Huatou Chan training']","['physical and emotional health (obsessive-compulsive, depression, hostility, and psychoticism), negative emotions (tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, and confusion-bewilderment), well-being, and attitude towards life', 'brain state', 'physical and emotional health', 'brain functioning', 'health']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1301808', 'cui_str': 'State'}]",70.0,0.012052,"Results showed that short-term Huatou Chan training had significant benefits on some aspects such as physical and emotional health (obsessive-compulsive, depression, hostility, and psychoticism), negative emotions (tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, and confusion-bewilderment), well-being, and attitude towards life.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'CAS Key Laboratory of Mental Health, Chinese Academy of Sciences, Institute of Psychology, 16 Lincui Road, Chaoyang District, Beijing 100101, PR China; Department of Psychology, University of Chinese Academy of Sciences, Beijing, PR China. Electronic address: luof@psych.ac.cn.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Qiang', 'Affiliation': 'Academy of Meditation Science - USCMS, P.O.Box 5515, Goodyear, AZ 85338, United States.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Beijing Easy Monitor Technology Development Co. Ltd, Beijing 100044, China.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'CAS Key Laboratory of Mental Health, Chinese Academy of Sciences, Institute of Psychology, 16 Lincui Road, Chaoyang District, Beijing 100101, PR China; Department of Psychology, University of Chinese Academy of Sciences, Beijing, PR China.'}, {'ForeName': 'Wenhong', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Academy of Meditation Science - USCMS, P.O.Box 5515, Goodyear, AZ 85338, United States.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Academy of Meditation Science - USCMS, P.O.Box 5515, Goodyear, AZ 85338, United States.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Beijing Easy Monitor Technology Development Co. Ltd, Beijing 100044, China.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.04.001']
139,34320552,Cognitive Behavioral Therapy for Sleep Disturbance and Fatigue Following Acquired Brain Injury: Predictors of Treatment Response.,"OBJECTIVE


To identify factors associated with treatment response to cognitive behavioral therapy for sleep disturbance and fatigue (CBT-SF) after acquired brain injury (ABI).
SETTING


Community dwelling.
PARTICIPANTS


Thirty participants with a traumatic brain injury or stroke randomized to receive CBT-SF in a parent randomized controlled trial.
DESIGN


Participants took part in a parallel-groups, parent randomized controlled trial with blinded outcome assessment, comparing an 8-week CBT-SF program with an attentionally equivalent health education control. They were assessed at baseline, post-treatment, 2 months post-treatment, and 4 months post-treatment. The study was completed either face-to-face or via telehealth (videoconferencing). Following this trial, a secondary analysis of variables associated with treatment response to CBT-SF was conducted, including: demographic variables; injury-related variables; neuropsychological characteristics; pretreatment sleep disturbance, fatigue, depression, anxiety and pain; and mode of treatment delivery (face-to-face or telehealth).
MAIN MEASURES


Pittsburgh Sleep Quality Index (PSQI) and Fatigue Severity Scale (FSS).
RESULTS


Greater treatment response to CBT-SF at 4-month follow-up was associated with higher baseline sleep and fatigue symptoms. Reductions in fatigue on the FSS were also related to injury mechanism, where those with a traumatic brain injury had a more rapid and short-lasting improvement in fatigue, compared with those with stroke, who had a delayed but longer-term reduction in fatigue. Mode of treatment delivery did not significantly impact CBT-SF outcomes.
CONCLUSION


Our findings highlight potential differences between fatigue trajectories in traumatic brain injury and stroke, and also provide preliminary support for the equivalence of face-to-face and telehealth delivery of CBT-SF in individuals with ABI.",2022,"RESULTS


Greater treatment response to CBT-SF at 4-month follow-up was associated with higher baseline sleep and fatigue symptoms.","['Thirty participants with a traumatic brain injury or stroke randomized to receive', 'Community dwelling']","['CBT-SF program with an attentionally equivalent health education control', 'cognitive behavioral therapy', 'face-to-face or via telehealth (videoconferencing', 'CBT-SF', 'Cognitive Behavioral Therapy']","['sleep disturbance, fatigue, depression, anxiety and pain; and mode of treatment delivery (face-to-face or telehealth', 'Sleep Disturbance and Fatigue', 'Pittsburgh Sleep Quality Index (PSQI) and Fatigue Severity Scale (FSS', 'baseline sleep and fatigue symptoms', 'sleep disturbance and fatigue (CBT-SF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",30.0,0.186717,"RESULTS


Greater treatment response to CBT-SF at 4-month follow-up was associated with higher baseline sleep and fatigue symptoms.","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ymer', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Australia (Drs Ymer, McKay, Wong, Grima, and Ponsford); Monash Epworth Rehabilitation Research Centre, Melbourne, Australia (Drs Ymer, McKay, Wong, Frencham, Grima, Nguyen, and Ponsford and Ms Tran); Department of Psychology, Epworth Rehabilitation, Melbourne, Australia (Drs Ymer, McKay, and Nguyen); and School of Psychology and Public Health, La Trobe University, Melbourne, Australia (Dr Wong).'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'McKay', 'Affiliation': ''}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Frencham', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grima', 'Affiliation': ''}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Tran', 'Affiliation': ''}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Ponsford', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000705']
140,34340926,The effect of salt-water bath in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane and platinum-based treatment.,"OBJECTIVES


In a clinical setting, patients have been observed to complain of discomfort and to discontinue treatment because of chemotherapy-induced peripheral neuropathy. This experimental study was conducted to determine the effect of a salt-water bath in the management of chemotherapy-induced peripheral neuropathy.
METHOD


One hundred and three patients who received taxane and platinum-based chemotherapy due to cancer and developed peripheral neuropathy associated with the treatment between December 2018 and June 2020 were included in the study. The patients were assigned to the control and experimental groups (1-warm salt-water and 2-cold salt-water) following the randomization checklist. While control groups did not receive any interventions, the patients in the salt-water group were asked to apply warm (41 °C) or cold-water (23-26 °C) baths to their hands/feet for 30 min every other day for 14 days. The data were collected at the beginning of the study and at the end of its first and second weeks using the Patient Information Form and National Cancer Institute (NCI)-CTCAE v5.0 toxicity criteria as well as the EORTC QLQ-C30 and EORTC QLQ-CIPN20 quality of life scales.
RESULTS


The patients had a mean age of 55.6 ± 10.3, and most of them were treated following a breast cancer diagnosis. At the beginning of the study, Grade 3 peripheral neuropathy severity and quality of life scores of the cold/warm salt-water and control groups were similar. Due to repeated follow-ups, it was determined that the peripheral neuropathy severity decreased and the quality of life scores increased statistically significantly in the patients in the cold salt-water bath group compared to the control group.
CONCLUSION


This study's results suggest that a cold salt-water bath can be an effective approach in managing the development of peripheral neuropathy due to taxane and platinum-based treatment.",2022,"Due to repeated follow-ups, it was determined that the peripheral neuropathy severity decreased and the quality of life scores increased statistically significantly in the patients in the cold salt-water bath group compared to the control group.
","['One hundred and three patients who received', 'due to cancer and developed peripheral neuropathy associated with the treatment between December 2018 and June 2020 were included in the study', 'patients had a mean age of 55.6\xa0±\xa010.3, and most of them were treated following a breast cancer diagnosis', 'cancer patients receiving taxane and platinum-based treatment']","['taxane and platinum-based chemotherapy', 'salt-water bath']","['peripheral neuropathy severity', 'quality of life scores', 'Grade 3 peripheral neuropathy severity and quality of life scores']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0337055', 'cui_str': 'Salt water'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",103.0,0.00407303,"Due to repeated follow-ups, it was determined that the peripheral neuropathy severity decreased and the quality of life scores increased statistically significantly in the patients in the cold salt-water bath group compared to the control group.
","[{'ForeName': 'Kayikci Emel', 'Initials': 'KE', 'LastName': 'Emine', 'Affiliation': 'Department of Nursing Istanbul Medeniyet University Faculty of Health Sciences, Atalar, Sht. Hakan Kurban Cd. No. 44, Kartal, Istanbul 34862, Turkey. Electronic address: emel.ozdemir@medeniyet.edu.tr.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Gulbeyaz', 'Affiliation': 'Department of Internal Medicine Nursing, Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing, Abide-i Hurriyet Cad, Caglayan, Istanbul, Turkey.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.07.002']
141,34344593,Long-Term Efficacy of a Home-Care Hypnosis Program in Elderly Persons Suffering From Chronic Pain: A 12-Month Follow-Up.,"BACKGROUND


Pain is a major public health concern in the aging population. However, medication brings about negative effects that compel healthcare professionals to seek alternative management techniques to alleviate pain. Hypnosis has been recognized as an effective technique to manage pain, but its long-term efficacy has yet to be examined in older adults.
AIMS


The aim was to assess the effectiveness, over a 12-month period, of home-care hypnosis in elderly participants suffering from chronic pain.
DESIGN


Real-life retrospective one-arm study with a 12-month follow-up.
SETTINGS


Elderly Persons Suffering From Chronic Pain enrolled in a clinical health care program that offered home medical follow-up.
PARTICIPANTS/SUBJECTS


Fourteen elderly women (mean age 81 years) with chronic pain participated in the home-care hypnosis program. All participants presented chronic pain (≥6 months) with average pain score >4/10.
METHODS


Participants took part in seven 15-minute hypnosis sessions within 12 months. The Brief Pain Inventory questionnaire was used to evaluate pain perception and pain interference at baseline and at 3-, 6-, and 12-month follow-up period.
RESULTS


Hypnosis home-care program significantly decreased pain perception and pain interference compared to baseline after 3 months (-29% and -40%, p < .001), and remained lower at 6 (-31% and -54%, p < .001) and 12 (-31% and -47%, p < .001) months.
CONCLUSIONS


Seven sessions of 15 minutes allocated throughout a 12-month period produced clinically significant decreases in pain perception and pain interference. Hypnosis could be considered as an optimal additional way for health practitioners to manage chronic pain in an elderly population with long-term efficacy. This study offers a new long-term option to improve chronic pain management at home in elderly populations through a low-cost nonpharmacological intervention.",2022,"RESULTS


Hypnosis home-care program significantly decreased pain perception and pain interference compared to baseline after 3 months (-29% and -40%, p < .001), and remained lower at 6 (-31% and -54%, p < .001) and 12 (-31% and -47%, p < .001) months.
","['elderly participants suffering from chronic pain', 'Fourteen elderly women (mean age 81 years) with chronic pain participated in the home-care hypnosis program', 'Elderly Persons Suffering From Chronic Pain', 'All participants presented chronic pain (≥6 months) with average pain score >4/10', 'Participants took part in seven 15-minute hypnosis sessions within 12 months', 'older adults', 'Elderly Persons Suffering From Chronic Pain enrolled in a clinical health care program that offered home medical follow-up']","['Home-Care Hypnosis Program', 'home-care hypnosis']","['chronic pain management', 'pain perception and pain interference', 'Brief Pain Inventory questionnaire']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",14.0,0.0743777,"RESULTS


Hypnosis home-care program significantly decreased pain perception and pain interference compared to baseline after 3 months (-29% and -40%, p < .001), and remained lower at 6 (-31% and -54%, p < .001) and 12 (-31% and -47%, p < .001) months.
","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Dumain', 'Affiliation': 'From the PRISMATICS Lab (Predictive Research In Spine/Neurostimulation Management And Thoracic Innovation in Cardiac Surgery), Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Jaglin', 'Affiliation': 'Rehabilitation Centre André Lalande - Fondation Partage et Vie, Noth, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': 'From the PRISMATICS Lab (Predictive Research In Spine/Neurostimulation Management And Thoracic Innovation in Cardiac Surgery), Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Rainville', 'Affiliation': ""Department of Stomatology, University of Montreal, Montreal, Quebec, Canada; Centre de recherche de l'institut universitaire de gériatrie de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pageaux', 'Affiliation': ""Centre de recherche de l'institut universitaire de gériatrie de Montréal, Montréal, Québec, Canada; École de kinésiologie et des sciences de l'activité physique (EKSAP), Faculté de médecine, Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Anaick', 'Initials': 'A', 'LastName': 'Perrochon', 'Affiliation': 'HAVAE EA 6310 Laboratory, University of Limoges, Limoges, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lavallière', 'Affiliation': 'Laboratoire de Recherche Biomécanique & Neurophysiologique en Réadaptation Neuro-Musculo-Squelettique-Lab BioNR, Department of Health Sciences, Centre Intersectoriel en Santé Durable (CISD), Module de Kinésiologie, Université du Québec à Chicoutimi, Saguenay, QC, Canada.'}, {'ForeName': 'Tanguy', 'Initials': 'T', 'LastName': 'Vendeuvre', 'Affiliation': 'From the PRISMATICS Lab (Predictive Research In Spine/Neurostimulation Management And Thoracic Innovation in Cardiac Surgery), Poitiers University Hospital, Poitiers, France; Department of Spine Surgery and Neuromodulation, Poitiers University Hospital, Poitiers, France; Pprime Institute UPR 3346, CNRS - University of Poitiers - ISAE-ENSMA, Poitiers, France; Department of Orthopaedic Surgery and Traumatology, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'David', 'Affiliation': 'From the PRISMATICS Lab (Predictive Research In Spine/Neurostimulation Management And Thoracic Innovation in Cardiac Surgery), Poitiers University Hospital, Poitiers, France; Physical and Rehabilitation Medicine Unit, Poitiers University Hospital, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Pascaline', 'Initials': 'P', 'LastName': 'Langlois', 'Affiliation': 'From the PRISMATICS Lab (Predictive Research In Spine/Neurostimulation Management And Thoracic Innovation in Cardiac Surgery), Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Cardinaud', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France; UPSAV, Department of Clinical Geriatric, University Hospital Center, Limoges, France.'}, {'ForeName': 'Achille', 'Initials': 'A', 'LastName': 'Tchalla', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rigoard', 'Affiliation': 'From the PRISMATICS Lab (Predictive Research In Spine/Neurostimulation Management And Thoracic Innovation in Cardiac Surgery), Poitiers University Hospital, Poitiers, France; Pprime Institute UPR 3346, CNRS - University of Poitiers - ISAE-ENSMA, Poitiers, France; Department of Orthopaedic Surgery and Traumatology, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Billot', 'Affiliation': 'From the PRISMATICS Lab (Predictive Research In Spine/Neurostimulation Management And Thoracic Innovation in Cardiac Surgery), Poitiers University Hospital, Poitiers, France. Electronic address: maxime.billot@chu-poitiers.fr.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2021.06.005']
142,34358324,Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy.,"STUDY OBJECTIVES


To assess the efficacy and safety of FT218, a novel once-nightly formulation of sodium oxybate (ON-SXB), in patients with narcolepsy in the phase 3 REST-ON trial.
METHODS


Narcolepsy patients aged ≥16 years were randomized 1:1 to uptitration of ON-SXB (4.5, 6, 7.5, and 9 g) or placebo. Three coprimary endpoints were change from baseline in mean sleep latency on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement rating, and weekly cataplexy attacks at 9, 7.5, and 6 g. Secondary endpoints included change from baseline on the Epworth Sleepiness Scale. Safety included adverse drug reactions and clinical laboratory assessments.
RESULTS


In total, 222 patients were randomized; 212 received ≥1 dose of ON-SXB (n = 107) or placebo (n = 105). For the three coprimary endpoints and Epworth Sleepiness Scale, all three doses of ON-SXB demonstrated clinically meaningful, statistically significant improvement versus placebo (all p < 0.001). For ON-SXB 9 g versus placebo, increase in mean sleep latency was 10.8 versus 4.7 min (Least squares mean difference, LSMD [95% CI], 6.13 [3.52 to 8.75]), 72.0% versus 31.6% were rated much/very much improved on Clinical Global Impression-Improvement (OR [95% CI], 5.56 [2.76 to 11.23]), change in mean weekly number of cataplexy attacks was -11.5 versus -4.9 (LSMD [95% CI], -6.65 [-9.32 to -3.98]), and change in Epworth Sleepiness Scale was -6.5 and -2.7 (LSMD [95% CI], -6.52 [-5.47 to -2.26]). Common adverse reactions included nausea, vomiting, headache, dizziness, and enuresis.
CONCLUSIONS


ON-SXB significantly improved narcolepsy symptoms; its safety profile was consistent with SXB. ON-SXB conferred efficacy with a clearly beneficial single nighttime dose.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: NCT02720744, https://clinicaltrials.gov/ct2/show/NCT02720744.",2022,"For ON-SXB 9 g vs placebo, increase in mean sleep latency was 10.8 vs 4.7 min (LSMD [95% CI], 6.13 [3.52-8.75]), 72.0% vs 31.6% were rated much/very much improved on Clinical Global Impression-Improvement (OR [95% CI], 5.56 [2.76-11.23]), change in mean weekly number of cataplexy attacks was -11.5 vs -4.9 (LSMD [95% CI], -6.65","['patients with narcolepsy in the phase 3 REST-ON trial', '222 patients were randomized; 212 received', 'Narcolepsy patients aged ≥16 years', 'Patients With Narcolepsy']","['Sodium Oxybate (FT218', 'sodium oxybate (ON-SXB', '≥1 dose of ON-SXB', 'uptitration of ON-SXB', 'placebo', 'FT218']","['mean sleep latency on the Maintenance of Wakefulness test, Clinical Global Impression-Improvement rating, and weekly cataplexy attacks', 'mean sleep latency', 'mean weekly number of cataplexy attacks', 'narcolepsy symptoms', 'nausea, vomiting, headache, dizziness, and enuresis', 'adverse drug reactions and clinical laboratory assessments', 'Epworth Sleepiness Scale', 'Clinical Global Impression-Improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037537', 'cui_str': 'Sodium Oxybate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}]",222.0,0.465217,"For ON-SXB 9 g vs placebo, increase in mean sleep latency was 10.8 vs 4.7 min (LSMD [95% CI], 6.13 [3.52-8.75]), 72.0% vs 31.6% were rated much/very much improved on Clinical Global Impression-Improvement (OR [95% CI], 5.56 [2.76-11.23]), change in mean weekly number of cataplexy attacks was -11.5 vs -4.9 (LSMD [95% CI], -6.65","[{'ForeName': 'Clete A', 'Initials': 'CA', 'LastName': 'Kushida', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University Medical Center, Redwood City, CA, USA.'}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'Shapiro', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thorpy', 'Affiliation': 'Department of Neurology, Montefiore Medical Center, New York, NY, USA.'}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Corser', 'Affiliation': 'Sleep Management Institute, Cincinnati, OH, USA.'}, {'ForeName': 'Akinyemi O', 'Initials': 'AO', 'LastName': 'Ajayi', 'Affiliation': 'Florida Pediatric Research Institute, Winter Park, FL, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'Neurotrials Research, Inc., Atlanta, GA, USA.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Ohio Sleep Medicine and Neuroscience Institute, Dublin, OH, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Seiden', 'Affiliation': 'Avadel Pharmaceuticals, Chesterfield, MO, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Dubow', 'Affiliation': 'Avadel Pharmaceuticals, Chesterfield, MO, USA.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, Sleep Unit, Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier, Univ Montpellier, INM INSERM, Montpellier, France.'}]",Sleep,['10.1093/sleep/zsab200']
143,33825230,Anti-seizure medications for Lennox-Gastaut syndrome.,"BACKGROUND


Lennox-Gastaut syndrome (LGS) is an age-specific epilepsy syndrome characterised by multiple seizure types, including drop seizures. LGS has a characteristic electroencephalogram, an onset before age eight years and an association with drug resistance. This is an updated version of the Cochrane Review published in 2013.
OBJECTIVES


To assess the efficacy and tolerability of anti-seizure medications (ASMs) for LGS.
SEARCH METHODS


We searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 28 February 2020) on 2 March 2020. CRS Web includes randomised controlled trials (RCTs) or quasi-RCTs from the Cochrane Central Register of Controlled Trials (CENTRAL); the Specialised Registers of Cochrane Review Groups, including Cochrane Epilepsy; PubMed; Embase; ClinicalTrials.gov; and the World Health Organization's International Clinical Trials Registry Platform (ICTRP). We imposed no language restrictions. We contacted pharmaceutical companies and colleagues in the field to seek any unpublished or ongoing studies.
SELECTION CRITERIA


We considered RCTs, including cross-over trials, of ASMs for LGS in children and adults. We included studies of ASMs used as either monotherapy or as an add-on (adjunctive) therapy. We excluded studies comparing different doses of the same ASM.
DATA COLLECTION AND ANALYSIS


We used standard Cochrane methodological procedures, including independent, dual assessment for risk of bias and application of the GRADE approach to rate the evidence certainty for outcomes.
MAIN RESULTS


We found no trials of ASM monotherapy. The review included 11 trials (1277 participants; approximately 11 weeks to 112 weeks follow-up after randomisation) using add-on ASMs for LGS in children, adolescents and adults. Two studies compared add-on cannabidiol (two doses) with add-on placebo in children and adolescents only. Neither study reported overall seizure cessation or reduction. We found high-certainty evidence that 72 more people per 1000 (confidence interval (CI) 4 more to 351 more) had adverse events (AE) leading to study discontinuation with add-on cannabidiol, compared to add-on placebo (two studies; 396 participants; risk ratio (RR) 4.90, 95% CI 1.21 to 19.87). One study compared add-on cinromide with add-on placebo in children and adolescents only. We found very low-certainty evidence that 35 more people per 1000 (CI 123 fewer to 434 more) had 50% or greater average reduction of overall seizures with add-on cinromide compared to add-on placebo (one study; 56 participants; RR 1.15, 95% CI 0.47 to 2.86). This study did not report participants with AE leading to study discontinuation. One study compared add-on clobazam (three doses) with add-on placebo. This study did not report overall seizure cessation or reduction. We found high-certainty evidence that 106 more people per 1000 (CI 0 more to 538 more) had AE leading to study discontinuation with add-on clobazam compared to add-on placebo (one study; 238 participants; RR 4.12, 95% CI 1.01 to 16.87). One study compared add-on felbamate with add-on placebo. No cases of seizure cessation occurred in either regimen during the treatment phase (one study; 73 participants; low-certainty evidence). There was low-certainty evidence that 53 more people per 1000 (CI 19 fewer to 716 more) with add-on felbamate were seizure-free during an EEG recording at the end of the treatment phase, compared to add-on placebo (RR 2.92, 95% CI 0.32 to 26.77). The study did not report overall seizure reduction. We found low-certainty evidence that one fewer person per 1000 (CI 26 fewer to 388 more) with add-on felbamate had AE leading to study discontinuation compared to add-on placebo (one study, 73 participants; RR 0.97, 95% CI 0.06 to 14.97). Two studies compared add-on lamotrigine with add-on placebo. Neither study reported overall seizure cessation. We found high-certainty evidence that 176 more people per 1000 (CI 30 more to 434 more) had ≥ 50% average seizure reduction with add-on lamotrigine compared to add-on placebo (one study; 167 participants; RR 2.12, 95% CI 1.19 to 3.76). We found low-certainty evidence that 40 fewer people per 1000 (CI 68 fewer to 64 more) had AE leading to study-discontinuation with add-on lamotrigine compared to add-on placebo (one study; 169 participants; RR 0.49, 95% CI 0.13 to 1.82). Two studies compared add-on rufinamide with add-on placebo. Neither study reported seizure cessation. We found high-certainty evidence that 202 more people per 1000 (CI 34 to 567 more) had ≥ 50% average seizure reduction (one study; 138 participants; RR 2.84, 95% CI 1.31 to 6.18). We found low-certainty evidence that 105 more people per 1000 (CI 17 fewer to 967 more) had AE leading to study discontinuation with add-on rufinamide compared to add-on placebo (one study; 59 participants; RR 4.14, 95% CI 0.49 to 34.86). One study compared add-on rufinamide with another add-on ASM. This study did not report overall seizure cessation or reduction. We found low-certainty evidence that three fewer people per 1000 (CI 75 fewer to 715 more) had AE leading to study discontinuation with add-on rufinamide compared to another add-on ASM (one study; 37 participants; RR 0.96, 95% CI 0.10 to 9.57). One study compared add-on topiramate with add-on placebo. This study did not report overall seizure cessation. We found low-certainty evidence for ≥ 75% average seizure reduction with add-on topiramate (one study; 98 participants; Peto odds ratio (Peto OR) 8.22, 99% CI 0.60 to 112.62) and little or no difference to AE leading to study discontinuation compared to add-on placebo; no participants experienced AE leading to study discontinuation (one study; 98 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS


RCTs of monotherapy and head-to-head comparison of add-on ASMs are currently lacking. However, we found high-certainty evidence for overall seizure reduction with add-on lamotrigine and rufinamide, with low-certainty evidence for AE leading to study discontinuation compared with add-on placebo or another add-on ASM. The evidence for other add-on ASMs for overall seizure cessation or reduction was low to very low with high- to low-certainty evidence for AE leading to study discontinuation. Future research should consider outcome reporting of overall seizure reduction (applying automated seizure detection devices), impact on development, cognition and behaviour; future research should also investigate age-specific efficacy of ASMs and target underlying aetiologies.",2021,"We found high-certainty evidence that 106 more people per 1000 (CI 0 more to 538 more) had AE leading to study discontinuation with add-on clobazam compared to add-on placebo (one study; 238 participants; RR 4.12, 95% CI 1.01 to 16.87).","['children and adolescents only', 'one study; 98 participants', 'children and adults', 'participants with AE leading to study discontinuation', 'Lennox-Gastaut syndrome', '1946 to 28 February 2020) on 2 March 2020', '11 trials (1277 participants; approximately 11 weeks to 112 weeks follow-up after randomisation) using add-on ASMs for LGS in children, adolescents and adults']","['LGS', 'anti-seizure medications (ASMs', 'placebo', 'clobazam', 'topiramate', 'lamotrigine']","['seizure reduction', 'seizure cessation', 'Peto odds ratio (Peto OR', 'adverse events (AE', 'efficacy and tolerability', 'average seizure reduction', 'overall seizure cessation', 'overall seizures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0055891', 'cui_str': 'clobazam'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",73.0,0.656066,"We found high-certainty evidence that 106 more people per 1000 (CI 0 more to 538 more) had AE leading to study discontinuation with add-on clobazam compared to add-on placebo (one study; 238 participants; RR 4.12, 95% CI 1.01 to 16.87).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Brigo', 'Affiliation': 'Department of Neurology, Hospital of Merano (SABES-ASDAA), Merano-Meran, Italy.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Cochrane Neuromuscular, Queen Square Centre for Neuromuscular Diseases, London, UK.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Eltze', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matricardi', 'Affiliation': 'Department of Child Neuropsychiatry, Children\'s Hospital ""G. Salesi"", Ospedali Riuniti Ancona, Ancona, Italy.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD003277.pub4']
144,33837986,Effects of motor imagery training on lower limb motor function of patients with chronic stroke: A pilot single-blind randomized controlled trial.,"AIMS


This pilot study aimed to evaluate the effects of motor imagery training on lower limb motor function of stroke patients.
BACKGROUND


Motor imagery training has played an important role in rehabilitation outcomes of stroke patients.
METHODS


In this pilot randomized controlled trial 32 stroke patients were randomly divided into experimental and control groups from January to June 2017. Patients in both groups received conventional neuro-rehabilitation five times a week in 3-h segments for 6 weeks. Patients in the experimental group underwent an additional 20 min of motor imagery training. Measures were evaluated by motor function of the lower extremity, activities of daily living and balance ability.
RESULTS


The outcomes significantly improved by motor imagery training were the Fugl-Meyer Assessment of the lower extremity, the Functional Independence Measure dealing with transfers and locomotion, and the Berg Balance Scale.
CONCLUSION


Motor imagery training could be used as a complement to physical rehabilitation of stroke patients. Our findings may be helpful to develop nursing strategies aimed at improving functional ability of stroke patients and thus enhancing their quality of life.",2022,"The outcomes significantly improved by motor imagery training were the Fugl-Meyer Assessment of the lower extremity, the Functional Independence Measure dealing with transfers and locomotion, and the Berg Balance Scale.
CONCLUSION


","['patients with stroke', '32 stroke patients', 'stroke patients', 'patients with chronic stroke', 'individuals by rehabilitation specialist nurses with sufficient experience of motor imagery training', 'practising psychomotor nursing skills']","['Motor imagery training', 'conventional neuro-rehabilitation', 'additional 20\u2009min of motor imagery training', 'motor imagery training', 'Six-week motor imagery training']","['motor performance of lower limbs', 'limb motor function', 'Fugl-Meyer Assessment of the lower extremity, the Functional Independence Measure dealing with transfers and locomotion, and the Berg Balance Scale.\nCONCLUSION', 'Lower extremity dyskinesia', 'motor imagery training', 'motor function of the lower extremity, activities of daily living and balance ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}]",,0.0069901,"The outcomes significantly improved by motor imagery training were the Fugl-Meyer Assessment of the lower extremity, the Functional Independence Measure dealing with transfers and locomotion, and the Berg Balance Scale.
CONCLUSION


","[{'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Yuan-Jiao', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation Medicine, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Xiao-Di', 'Initials': 'XD', 'LastName': 'Ding', 'Affiliation': ""Department of Neurology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Tian-Ming', 'Initials': 'TM', 'LastName': 'Shi', 'Affiliation': ""Department of Neurology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}]",International journal of nursing practice,['10.1111/ijn.12933']
145,34319948,Video Consent for Colonoscopy Improves Knowledge Retention and Patient Satisfaction: A Randomized Controlled Study.,"BACKGROUND AND AIM


Informed consent for endoscopy is variable across institutions and remains understudied in gastrointestinal endoscopy. This study aims to standardize informed consent for screening and diagnostic colonoscopies with a supplemental video tool that includes the key components of informed consent.
METHODS


A video tool was developed that incorporated the key components of informed consent for colonoscopy. In addition, a 7-question survey was developed to query patients on core aspects of informed consent and satisfaction with the informed consent process. Patients undergoing elective outpatient colonoscopy with conscious sedation were randomized to traditional consent or consent with the addition of a video tool. A pilot study determined the sample size. Traditional consent was standard of practice before the procedure. Patients in the video tool group watched the video tool in the preprocedure area followed by traditional consent. Both groups had the opportunity to address questions with the attending physician before the procedure. All patients were contacted 1 to 2 days following the colonoscopy to answer the question survey.
RESULTS


A total of 110 patients were eligible for participation, and 91 were included in the final data analysis. Subjects in the video tool group demonstrated significantly higher recall of key aspects of informed consent and higher satisfaction with the informed consent process versus the traditional consent group. The history of prior colonoscopy was similar between both groups. Mean endoscopy operation metrics were not negatively impacted by the inclusion of the video tool.
CONCLUSION


Patients undergoing screening and diagnostic colonoscopies who received informed consent supplemented by a video tool had a higher recall of core aspects of informed consent and higher satisfaction with the process, with no impact on procedural times.",2022,Subjects in the video tool group demonstrated significantly higher recall of key aspects of informed consent and higher satisfaction with the informed consent process versus the traditional consent group.,"['110 patients were eligible for participation, and 91 were included in the final data analysis', 'Patients undergoing screening and diagnostic colonoscopies', 'Patients undergoing elective outpatient colonoscopy with conscious sedation']",[],"['Knowledge Retention and Patient Satisfaction', 'higher recall of key aspects of informed consent and higher satisfaction', 'Mean endoscopy operation metrics']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0400018', 'cui_str': 'Diagnostic endoscopic examination on colon'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",110.0,0.0506232,Subjects in the video tool group demonstrated significantly higher recall of key aspects of informed consent and higher satisfaction with the informed consent process versus the traditional consent group.,"[{'ForeName': 'Ruthvik', 'Initials': 'R', 'LastName': 'Padival', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Nutrition, Digestive Diseases and Surgery Institute.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Harris', 'Affiliation': 'Department of Internal Medicine, Community Care Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Garber', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Nutrition, Digestive Diseases and Surgery Institute.'}, {'ForeName': 'Faris', 'Initials': 'F', 'LastName': 'El-Khider', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Nutrition, Digestive Diseases and Surgery Institute.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kichler', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Nutrition, Digestive Diseases and Surgery Institute.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vargo', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Nutrition, Digestive Diseases and Surgery Institute.'}, {'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Baggott', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Nutrition, Digestive Diseases and Surgery Institute.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001589']
146,34375135,MR-proANP and NT-proBNP During Targeted Temperature Management Following Out-of-Hospital Cardiac Arrest: A  Post hoc  Analysis of the TTH48 Trial.,"We aimed to evaluate the effect of prolonged targeted temperature management (TTM) in patients with out-of-hospital cardiac arrest (OHCA) on the levels of midregional pro-atrial natriuretic peptide (MR-proANP) and N-terminal pro b-type natriuretic peptide (NT-proBNP) and assess their potential as prognostic biomarkers. A preplanned  post hoc  analysis of ""Targeted temperature management for 48 h vs 24 h and neurologic outcome after out-of-hospital cardiac arrest: A randomized clinical trial (TTH48 trial),"" where patients were randomized to TTM at 33°C ± 1°C of standard duration (24 hours) versus prolonged (48 hours). Blood samples were drawn from patients with OHCA at two Scandinavian university hospitals at admission to the ICU and at 24, 48, and 72 hours after reaching the target temperature. Primary outcome was levels of MR-proANP and NT-proBNP. Secondary outcome was cerebral performance category (CPC 1-5) at 6 months. Samples from 114 patients were analyzed. Prolonged TTM significantly decreased the levels of MR-proANP and NT-proBNP at 48 hours compared with standard 24 hours-TTM ( p  < 0.01). However, there were no significant differences at other time points. Patients with poor outcome (CPC 3-5) had a statistically significantly increased MR-proANP level at 24 hours ( p  < 0.01) and 72 hours ( p  < 0.01) compared with the good outcome group (CPC 1-2). Prognostic performance was best at 24 hours for both MR-proANP and NT-proBNP; with an AUC of 0.73 (confidence interval [95% CI]: 0.63-0.83) and 0.72 (95 % CI: 0.59-0.85), respectively. Prolonged TTM lowered the levels of both MR-proANP and NT-proBNP at 48 hours. MR-proANP may add prognostic information in postcardiac arrest patients. ClinicalTrials.gov ID: NCT01689077.",2022,Prolonged TTM significantly decreased the levels of MR-proANP and NT-proBNP at 48 hours compared with standard 24 hours-TTM ( p  < 0.01).,"['patients with out-of-hospital cardiac arrest (OHCA) on the levels of midregional pro-atrial natriuretic peptide (MR-proANP) and N-terminal pro b-type', '114 patients were analyzed', 'postcardiac arrest patients']","['MR-proANP', 'TTM', 'prolonged targeted temperature management (TTM', 'natriuretic peptide (NT-proBNP', 'MR-proANP and NT-proBNP']","['cerebral performance category (CPC 1-5', 'levels of MR-proANP and NT-proBNP', 'neurologic outcome', 'Prognostic performance', 'MR-proANP level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",114.0,0.15988,Prolonged TTM significantly decreased the levels of MR-proANP and NT-proBNP at 48 hours compared with standard 24 hours-TTM ( p  < 0.01).,"[{'ForeName': 'Henriette Michelsen', 'Initials': 'HM', 'LastName': 'Bach', 'Affiliation': 'Department of Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christophe Henri Valdemar', 'Initials': 'CHV', 'LastName': 'Duez', 'Affiliation': 'Department of Otorhinolaryngology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anni Nørgaard', 'Initials': 'AN', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Anesthesiology, Regional Hospital West Jutland, Herning, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Strand', 'Affiliation': 'Department of Intensive Care, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Søreide', 'Affiliation': 'Critical Care and Anesthesiology Research Group and Department of Clinical Medicine, Stavanager University Hospital, Stavanger, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Center for Emergency Medicine, Emergency Department and Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anders Morten', 'Initials': 'AM', 'LastName': 'Grejs', 'Affiliation': 'Department of Intensive Care, Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",Therapeutic hypothermia and temperature management,['10.1089/ther.2021.0012']
147,33838536,"Ultrasound-guided erector spinae plane block for postoperative analgesia in patients undergoing open radical prostatectomy: A randomized, placebo-controlled trial.","STUDY OBJECTIVE


The aim of this study was to evaluate the effect of ultrasound-guided erector spinae plane (ESP) block on postoperative pain in radical prostatectomy, which leads to both visceral and somatic pain.
DESIGN


Prospective, randomized, placebo controlled, double-blinded.
SETTING


University hospital.
PATIENTS


A total of ASA I-III, 50 patients aged 18-65 who were scheduled for elective open radical prostatectomy surgery.
INTERVENTIONS


Patients were randomly allocated to receive an ultrasound-guided ESP block, with either local anesthetic (10 mL of 1% lidocaine +10 mL of 0.5% bupivacaine) or placebo bilaterally.
MEASUREMENTS


The primary outcome was morphine consumption in the first 24 h after surgery. The secondary outcomes were NRS pain scores at rest and coughing, intraoperative remifentanil consumption and need for rescue analgesic during the first 24 h after surgery.
MAIN RESULTS


Both NRS scores for post-anesthesia care unit and NRS rest  scores for 1st hours were lower in Group ESPB (p < 0.001 and p = 0.033, respectively). Cumulative morphine consumption at 24 h post-surgery was similar between the groups (p = 0.447). Rescue analgesic requirement was higher in the placebo injection group than in the ESPB group at the 1st postoperative hour (p = 0.002).
CONCLUSIONS


In open radical prostatectomies, except for the first hour, ESP block is ineffective for pain scores and on morphine consumption compared to the placebo injection group in the postoperative period.",2021,"Both NRS scores for post-anesthesia care unit and NRS rest  scores for 1st hours were lower in Group ESPB (p < 0.001 and p = 0.033, respectively).","['50 patients aged 18-65 who were scheduled for elective open radical prostatectomy surgery', 'University hospital', 'patients undergoing open radical prostatectomy']","['ultrasound-guided erector spinae plane (ESP) block', 'ultrasound-guided ESP block, with either local anesthetic (10\xa0mL of 1% lidocaine +10\xa0mL of 0.5% bupivacaine', 'ESPB', 'placebo bilaterally', 'Ultrasound-guided erector spinae plane block', 'placebo']","['Rescue analgesic requirement', 'pain scores', 'morphine consumption', 'Cumulative morphine consumption', 'NRS pain scores at rest and coughing, intraoperative remifentanil consumption and need for rescue analgesic during the first 24\xa0h after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",65.0,0.745673,"Both NRS scores for post-anesthesia care unit and NRS rest  scores for 1st hours were lower in Group ESPB (p < 0.001 and p = 0.033, respectively).","[{'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Dost', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey. Electronic address: burhandost@hotmail.com.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Kaya', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Yasemin Burcu', 'Initials': 'YB', 'LastName': 'Ustun', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Koksal', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Sezgin', 'Initials': 'S', 'LastName': 'Bilgin', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Bostancı', 'Affiliation': 'Department of Urology, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110277']
148,34331348,"Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis.","Fedratinib, an oral Janus kinase-2 (JAK2) inhibitor, reduces splenomegaly and improves symptom burden in patients with myelofibrosis. Regulatory approval of fedratinib 400-mg daily was based on results of an updated analysis of the pivotal phase III, placebo-controlled JAKARTA trial in patients with JAK-inhibitor-naïve myelofibrosis. At week 24, spleen volume response rate was 47% and symptom response rate was 40% with fedratinib 400 mg, versus 1% and 9% respectively, with placebo. Common adverse events were diarrhoea, nausea, anaemia, and vomiting. No Wernicke encephalopathy occurred in patients receiving fedratinib 400 mg/day. These updated data support use of first-line fedratinib in patients with myelofibrosis.",2021,"Fedratinib, an oral Janus kinase-2 (JAK2) inhibitor, reduces splenomegaly and improves symptom burden in patients with myelofibrosis.","['patients with intermediate-2 or high-risk myelofibrosis', 'patients with JAK-inhibitor-naïve myelofibrosis', 'patients with myelofibrosis']",['placebo'],"['symptom response rate', 'diarrhoea, nausea, anaemia, and vomiting', 'spleen volume response rate', 'Wernicke encephalopathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001815', 'cui_str': 'Myelosclerosis with myeloid metaplasia'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0043121', 'cui_str': ""Wernicke's disease""}]",,0.259538,"Fedratinib, an oral Janus kinase-2 (JAK2) inhibitor, reduces splenomegaly and improves symptom burden in patients with myelofibrosis.","[{'ForeName': 'Animesh', 'Initials': 'A', 'LastName': 'Pardanani', 'Affiliation': 'Mayo Clinic of Rochester, Rochester, MN, USA.'}, {'ForeName': 'Ayalew', 'Initials': 'A', 'LastName': 'Tefferi', 'Affiliation': 'Mayo Clinic of Rochester, Rochester, MN, USA.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Masszi', 'Affiliation': 'Department of Internal Medicine and Haematology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Mishchenko', 'Affiliation': 'Lady Davis Medical Center, Haifa, Israel.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drummond', 'Affiliation': 'Beatson Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jourdan', 'Affiliation': 'CHU Caremeau, Nimes, France.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Vannucchi', 'Affiliation': 'University of Florence, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Jurgutis', 'Affiliation': 'Klaipeda Jurininku Hospital, Klaipeda, Lithuania.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Department of Oncology and Hematology, University of Milan, Milan, Italy.'}, {'ForeName': 'Liang Piu', 'Initials': 'LP', 'LastName': 'Koh', 'Affiliation': 'National University Hospital Singapore, Singapore, Singapore.'}, {'ForeName': 'Shelonitda', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Harrison', 'Affiliation': ""Guy's and St Thomas' Hospital, London, UK.""}]",British journal of haematology,['10.1111/bjh.17727']
149,34334677,The Effect of Vibration on Pain During Heel Lance Procedures in Newborns: A Randomized Controlled Trial.,"BACKGROUND/SIGNIFICANCE


The pain-reducing effect of applying vibration, which is used as a nonpharmacological method in pain management, is explained by the gate control theory developed by Melzack and Wall. Studies that are based on this theory have shown similar results to those of Melzack and Wall, indicating that pain-transmitting nerves are suppressed by vibrations, leading to higher pain thresholds.
PURPOSE


The study aimed to evaluate the effect of applying vibration to manage pain during heel lance procedures in newborns.
METHODS


This is a randomized, controlled experimental study. The study sample included 56 newborns determined using power analysis (vibration group = 28; control group = 28). For those in the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and then continued throughout the procedure. No interventions were provided to the newborns in the control group. Pain in the newborns was evaluated by the nurse who performed the heel lance procedures, before the procedures and 15 to 20 seconds and 5 minutes after procedures, and by 2 specialists who viewed the video footage and conducted the Neonatal Infant Pain Scale examination.
RESULTS


The pain scores were significantly lower at 15 to 20 seconds and 5 minutes after the heel lance procedures in the group that received vibrations than in the control group (P < .05).
IMPLICATIONS FOR PRACTICE


The application of vibration, which is effective, nonpharmacological, and noninvasive, could help nurses manage pain in newborns as a nonpharmacological method.
IMPLICATIONS FOR RESEARCH


The number of studies that examine the effect that vibration has on pain associated with heel lance procedures in newborns is very limited, and it is recommended that further studies be conducted with larger sample sizes.",2022,"The pain scores were significantly lower at 15 to 20 seconds and 5 minutes after the heel lance procedures in the group that received vibrations than in the control group (P < .05).
","['newborns', '56 newborns determined using power analysis (vibration group = 28; control group = 28', 'Newborns']",['Vibration'],"['Pain', 'pain scores']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",56.0,0.0441291,"The pain scores were significantly lower at 15 to 20 seconds and 5 minutes after the heel lance procedures in the group that received vibrations than in the control group (P < .05).
","[{'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Avan Antepli', 'Affiliation': 'Sanliurfa Birecik Cuma Gokdogan Primary Care Clinic No. 3, Turkey (Ms Avan Antepli); Department of Nursing, Faculty of Health Sciences, Gaziantep University, Gaziantep, Turkey (Dr Bilsin Kocamaz); and Department of Nursing, Faculty of Health Sciences, Gaziantep Islamic Science and Technology University, Gaziantep, Turkey (Dr Güngörmüş).'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Bilsin Kocamaz', 'Affiliation': ''}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Güngörmüş', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000918']
150,33860699,A mobile app that uses neurofeedback and multi-sensory learning methods improves reading abilities in dyslexia: A pilot study.,"Reading comprehension is difficult to improve for children with dyslexia because of the continuing demands of orthographic decoding in combination with limited working memory capacity. Children with dyslexia get special education that improves spelling, phonemic and vocabulary awareness, however the latest research indicated that special education does not improve reading comprehension. With the aim of improving reading comprehension, reading speed and all other reading abilities of children with dyslexia, Auto Train Brain that is a novel mobile app using neurofeedback and multi-sensory learning methods was developed. With a clinical study, we wanted to demonstrate the effectiveness of Auto Train Brain on reading abilities. We compared the cognitive improvements obtained with Auto Train Brain with the improvements obtained with special dyslexia training. Auto Train Brain was applied to 16 children with dyslexia 60 times for 30 minutes. The control group consisted of 14 children with dyslexia who did not have remedial training with Auto Train Brain, but who did continue special education. The TILLS test was applied to both the experimental and the control group at the beginning of the experiment and after a 6-month duration from the first TILLS test. Comparison of the pre- and post- TILLS test results indicated that applying neurofeedback and multi-sensory learning method improved reading comprehension of the experimental group more than that of the control group statistically significantly. Both Auto Train Brain and special education improved phonemic awareness and nonword spelling.",2022,TILLS test results indicated that applying neurofeedback and multi-sensory learning method improved reading comprehension of the experimental group more than that of the control group statistically significantly.,"['14 children with', 'Children with dyslexia get special education', 'children with dyslexia', '16 children with dyslexia 60 times for 30\u2009minutes', 'dyslexia', 'children with dyslexia, Auto Train Brain']","['pre- and post', 'dyslexia who did not have remedial training with Auto Train Brain, but who did continue special education']","['reading comprehension', 'spelling, phonemic and vocabulary awareness', 'reading abilities', 'phonemic awareness and nonword spelling']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",14.0,0.0405536,TILLS test results indicated that applying neurofeedback and multi-sensory learning method improved reading comprehension of the experimental group more than that of the control group statistically significantly.,"[{'ForeName': 'Günet', 'Initials': 'G', 'LastName': 'Eroğlu', 'Affiliation': 'Department of Computer Engineering, Işık University, Istanbul, Turkey.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Teber', 'Affiliation': 'Child Neurology Department, Medical Faculty, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Kardelen', 'Initials': 'K', 'LastName': 'Ertürk', 'Affiliation': 'HMS Health Mobile Software A.S, Kayseri, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Kırmızı', 'Affiliation': 'Neuro Brain Academy, Izmir, Turkey.'}, {'ForeName': 'Barıs', 'Initials': 'B', 'LastName': 'Ekici', 'Affiliation': 'Özel Çocuk Nörolojisi Kliniği, Fulya, Istanbul, Turkey.'}, {'ForeName': 'Fehim', 'Initials': 'F', 'LastName': 'Arman', 'Affiliation': 'Neurology Department, Acıbadem Hastanesi Kadıköy, Istanbul, Turkey.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Balcisoy', 'Affiliation': 'Department of Engineering and Natural Sciences, Sabancı University, İstanbul, Turkey.'}, {'ForeName': 'Yusuf Ziya', 'Initials': 'YZ', 'LastName': 'Özcan', 'Affiliation': 'HMS Health Mobile Software A.S, Kayseri, Turkey.'}, {'ForeName': 'Müjdat', 'Initials': 'M', 'LastName': 'Çetin', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, NY, USA.'}]",Applied neuropsychology. Child,['10.1080/21622965.2021.1908897']
151,33887209,"Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1-2, dose-ranging study.","BACKGROUND


CoV2 preS dTM is a stabilised pre-fusion spike protein vaccine produced in a baculovirus expression system being developed against SARS-CoV-2. We present interim safety and immunogenicity results of the first-in-human study of the CoV2 preS dTM vaccine with two different adjuvant formulations.
METHODS


This phase 1-2, randomised, double-blind study is being done in healthy, SARS-CoV-2-seronegative adults in ten clinical research centres in the USA. Participants were stratified by age (18-49 years and ≥50 years) and randomly assigned using an interactive response technology system with block randomisation (blocks of varying size) to receive one dose (on day 1) or two doses (on days 1 and 22) of placebo or candidate vaccine, containing low-dose (effective dose 1·3 μg) or high-dose (2·6 μg) antigen with adjuvant AF03 (Sanofi Pasteur) or AS03 (GlaxoSmithKline) or unadjuvanted high-dose antigen (18-49 years only). Primary endpoints were safety, assessed up to day 43, and immunogenicity, measured as SARS-C0V-2 neutralising antibodies (geometric mean titres), assessed on days 1, 22, and 36 serum samples. Safety was assessed according to treatment received in the safety analysis set, which included all randomly assigned participants who received at least one dose. Neutralising antibody titres were assessed in the per-protocol analysis set for immunogenicity, which included participants who received at least one dose, met all inclusion and exclusion criteria, had no protocol deviation, had negative results in the neutralisation test at baseline, and had at least one valid post-dose serology sample. This planned interim analysis reports data up to 43 days after the first vaccination; participants in the trial will be followed up for 12 months after the last study injection. This trial is registered with ClinicalTrials.gov, NCT04537208, and is ongoing.
FINDINGS


Between Sept 3 and Sept 29, 2020, 441 individuals (299 aged 18-49 years and 142 aged ≥50 years) were randomly assigned to one of the 11 treatment groups. The interim safety analyses included 439 (>99%) of 441 randomly assigned participants (299 aged 18-49 years and 140 aged ≥50 years). Neutralising antibody titres were analysed in 326 (74%) of 441 participants (235 [79%] of 299 aged 18-49 years and 91 [64%] of 142 aged ≥50 years). There were no vaccine-related unsolicited immediate adverse events, serious adverse events, medically attended adverse events classified as severe, or adverse events of special interest. Among all study participants, solicited local and systemic reactions of any grade after two vaccine doses were reported in 81% (95% CI 61-93; 21 of 26) of participants in the low-dose plus AF03 group, 93% (84-97; 74 of 80) in the low-dose plus AS03 group, 89% (70-98; 23 of 26) in the high-dose plus AF03 group, 95% (88-99; 81 of 85) in the high-dose plus AS03 group, 29% (10-56; five of 17) in the unadjuvanted high-dose group, and 21% (8-40; six of 29) in the placebo group. A single vaccine dose did not generate neutralising antibody titres above placebo levels in any group at days 22 or 36. Among participants aged 18-49 years, neutralising antibody titres after two vaccine doses were 13·1 (95% CI 6·40-26·9) in the low-dose plus AF03 group, 20·5 (13·1-32·1) in the low-dose plus AS03 group, 43·2 (20·6-90·4) in the high-dose plus AF03 group, 75·1 (50·5-112·0) in the high-dose plus AS03 group, 5·00 (not calculated) in the unadjuvanted high-dose group, and 5·00 (not calculated) in the placebo group. Among participants aged 50 years or older, neutralising antibody titres after two vaccine doses were 8·62 (1·90-39·0) in the low-dose plus AF03 group, 12·9 (7·09-23·4) in the low-dose plus AS03 group, 12·3 (4·35-35·0) in the high-dose plus AF03 group, 52·3 (25·3-108·0) in the high-dose plus AS03 group, and 5·00 (not calculated) in the placebo group.
INTERPRETATION


The lower than expected immune responses, especially in the older age groups, and the high reactogenicity after dose two were probably due to higher than anticipated host-cell protein content and lower than planned antigen doses in the formulations tested, which was discovered during characterisation studies on the final bulk drug substance. Further development of the AS03-adjuvanted candidate vaccine will focus on identifying the optimal antigen formulation and dose.
FUNDING


Sanofi Pasteur and Biomedical Advanced Research and Development Authority.",2021,A single vaccine dose did not generate neutralising antibody titres above placebo levels in any group at days 22 or 36.,"['healthy, SARS-CoV-2-seronegative adults in ten clinical research centres in the USA', '439 (>99%) of 441 randomly assigned participants (299 aged 18-49 years and 140 aged ≥50 years', '441 individuals (299 aged 18-49 years and 142 aged ≥50 years', 'participants aged 18-49 years', 'participants aged 50 years or older, neutralising antibody titres after two vaccine doses were 8·62 (1·90-39·0) in the low-dose plus AF03 group, 12·9', 'participants who received at least one dose, met all inclusion and exclusion criteria, had no protocol deviation, had negative results in the neutralisation test at baseline, and had at least one valid post-dose serology sample', '326 (74%) of 441 participants (235 [79%] of 299 aged 18-49 years and 91 [64%] of 142 aged ≥50 years', 'Participants were stratified by age (18-49 years and ≥50 years', 'healthy adults']","['placebo or candidate vaccine, containing low-dose (effective dose 1·3 μg) or high-dose (2·6 μg) antigen with adjuvant AF03 (Sanofi Pasteur) or AS03 (GlaxoSmithKline) or unadjuvanted high-dose antigen', 'interactive response technology system with block randomisation (blocks of varying size', 'placebo', 'SARS-CoV-2 recombinant protein vaccine formulations']","['solicited local and systemic reactions', 'neutralising antibody titres above placebo levels', 'neutralising antibody titres', 'safety, assessed up to day 43, and immunogenicity, measured as SARS-C0V-2 neutralising antibodies (geometric mean titres', 'Safety', 'Neutralising antibody titres', 'unsolicited immediate adverse events, serious adverse events, medically attended adverse events classified as severe, or adverse events of special interest']","[{'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C4704700', 'cui_str': 'Null Results'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0034861', 'cui_str': 'Recombinant protein'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",299.0,0.415883,A single vaccine dose did not generate neutralising antibody titres above placebo levels in any group at days 22 or 36.,"[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Goepfert', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Chabanon', 'Affiliation': 'Sanofi Pasteur, Lyon, France.'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Bonaparte', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Davis', 'Affiliation': 'Rochester Clinical Research, Rochester, NY, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Essink', 'Affiliation': 'Meridian Clinical Research, Omaha, NE, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': 'Division of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Haney', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Janosczyk', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Keefer', 'Affiliation': 'University of Rochester, School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GlaxoSmithKline Vaccines, Wavre, Belgium.'}, {'ForeName': 'Murray A', 'Initials': 'MA', 'LastName': 'Kimmel', 'Affiliation': 'Optimal Research, Melbourne, FL, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Masotti', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Savarino', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Lode', 'Initials': 'L', 'LastName': 'Schuerman', 'Affiliation': 'GlaxoSmithKline Vaccines, Wavre, Belgium.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schwartz', 'Affiliation': 'Research Centers of America, Hollywood, FL, USA.'}, {'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates, CA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Tavares-Da-Silva', 'Affiliation': 'GlaxoSmithKline Vaccines, Wavre, Belgium.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gurunathan', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'de Bruyn', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: guy.debruyn@sanofi.com.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00147-X']
152,33906814,Effectiveness of self-compassion training on hopelessness and resilience in parents of children with cancer.,"OBJECTIVES


the psychological state of parents, who are considered the primary caregivers of a sick child, can affect the child's behavior and emotions. This study analyzed the effectiveness of self-compassion training on hopelessness and resilience in the parents of children with cancer.
METHODS


this was an experimental study with a pre-test and post-test design and a control group. The statistical population included all parents of children with cancer hospitalized in Amir Kabir Hospital of Arak in 2020. The research sample consisted of 30 parents of children with cancer selected through convenience sampling. The participants were equally divided into experimental (n = 15) and control (n = 15) groups at random. The research instruments were the Connor-Davidson Resilience Scale (CD-RISC) and the Beck Hopelessness Scale (BHS). The experimental group underwent eight 90 min sessions of self-compassion training on a weekly basis. Finally, the multivariate analysis of covariance (MANCOVA) was employed for data analysis.
RESULTS


the mean (±SD) of the post-test scores of hopelessness and resilience were reported 10.20 (±4.95) and 43.33 (±4.27), respectively, in the experimental group, whereas they were reported 13.78 (±4.94) and 38.73 (±4.07), respectively, in the control group. According to the results, self-compassion training had significant effects on the resilience and hopelessness of the parents of children with cancer (p < 0.01). Self-compassion training had a positive, significant effect on their resilience. It was also efficient in decreasing their hopelessness.
CONCLUSIONS


self-compassion training improved resilience and mitigated hopelessness in the parents of children with cancer.",2022,"This study analyzed the effectiveness of self-compassion training on hopelessness and resilience in the parents of children with cancer.
","['parents of children with cancer', 'children with cancer hospitalized in Amir Kabir Hospital of Arak in 2020', '30 parents of children with cancer selected through convenience sampling']","['self-compassion training', 'Self-compassion training']","['resilience and mitigated hopelessness', 'Connor-Davidson Resilience Scale (CD-RISC) and the Beck Hopelessness Scale (BHS', 'resilience and hopelessness of the parents of children with cancer', 'hopelessness and resilience']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582612', 'cui_str': 'Beck hopelessness scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",,0.0255791,"This study analyzed the effectiveness of self-compassion training on hopelessness and resilience in the parents of children with cancer.
","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Khosrobeigi', 'Affiliation': 'Department of Health Psychology, Khorramshahr-Persian Gulf International Branch, Islamic Azad University, Khorramshahr, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Hafezi', 'Affiliation': 'Department of Psychology, Ahvaz Branch, Islamic Azad University, Ahvaz, Iran. Electronic address: fhaffezi@gmail.com.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Naderi', 'Affiliation': 'Department of Psychology, Ahvaz Branch, Islamic Azad University, Ahvaz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Ehteshamzadeh', 'Affiliation': 'Department of Psychology, Ahvaz Branch, Islamic Azad University, Ahvaz, Iran.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.04.003']
153,33830898,A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury.,"CONTEXT/OBJECTIVES


Wheelchair users with chronic shoulder pain have few options after conservative treatments fail. This pilot study's purpose was to establish safety and treatment effects of micro-fragmented adipose tissue (MFAT) injections under ultrasound guidance for treatment of refractory shoulder pain caused by rotator cuff disease in wheelchair users with spinal cord injury (SCI) to prepare for a larger trial.
DESIGN


Pilot clinical trial.
SETTING


Rehabilitation hospital outpatient clinic.
PARTICIPANTS


Ten wheelchair users with chronic SCI who had moderate-to-severe shoulder pain caused by refractory rotator cuff disease (diagnosed via ultrasound) for greater than 6 months.
INTERVENTIONS


Ultrasound-guided injections of MFAT into the pathologic rotator cuff tendons and other abnormal shoulder structures (e.g. acromioclavicular and glenohumeral joints; subacromial bursa).
OUTCOME MEASURES


6- and 12-month changes in 11-point Numerical Rating Scale (NRS); Wheelchair User's Shoulder Pain Index (WUSPI); Brief Pain Inventory pain interference items (BPI-I7); Patient Global Impression of Change (PGIC); ultrasound and physical exams; and adverse events.
CONCLUSIONS


There were no significant adverse events throughout the study period. WUSPI, NRS, and BPI-I7 scores were significantly lower 6 and 12 months post-procedure (P < .05). Of those who remained in the trial, clinically meaningful changes (≥30% decrease) in WUSPI, NRS, and BPI-I7 scores were observed in 77.8%, 77.8%, and 66.7% of participants, respectively. All but one participant reported improvement in clinical status. MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in wheelchair users with SCI. A larger, randomized controlled trial has been initiated. Trial registration : ClinicalTrials.gov identifier: NCT03167138.",2021,MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in wheelchair users with SCI.,"['Wheelchair users with chronic shoulder pain', 'wheelchair users with spinal cord injury (SCI', 'Rehabilitation hospital outpatient clinic', 'wheelchair users with spinal cord injury', 'Ten wheelchair users with chronic SCI who had moderate-to-severe shoulder pain caused by refractory rotator cuff disease (diagnosed via ultrasound) for greater than 6 months']","['Ultrasound-guided injections of MFAT', 'micro-fragmented adipose tissue (MFAT) injections under ultrasound guidance', 'MFAT injection under ultrasound guidance', 'micro-fragmented adipose tissue injection under ultrasound guidance']","['adverse events', 'WUSPI, NRS, and BPI-I7 scores', ""Wheelchair User's Shoulder Pain Index (WUSPI); Brief Pain Inventory pain interference items (BPI-I7); Patient Global Impression of Change (PGIC); ultrasound and physical exams; and adverse events"", '11-point Numerical Rating Scale (NRS']","[{'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.102314,MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in wheelchair users with SCI.,"[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hogaboom', 'Affiliation': 'Kessler Foundation, West Orange, New Jersey, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Malanga', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Cherian', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, New Jersey, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2021.1903140']
154,33832384,Mitigating medical student stress and anxiety: Should schools mandate participation in wellness intervention programs?,"PURPOSE


Medical students are at increased risk of poor mental health and need to regularly engage in preventive programs to maintain well-being. However, many do not and it remains an open question whether these programs should be mandatory. We implemented a RCT to examine the effectiveness of assigning medical students to a wellness intervention on adherence to engagement in the assigned intervention and on psychological and academic outcomes.
METHOD


Medical students participated in a 12-week randomized controlled intervention involving one-hour wellness sessions of either (1) yoga; (2) mindfulness; or (3) walking, held twice-weekly. Students completed standardized psychological assessments at baseline and following the intervention.
RESULTS


Students randomized to the wellness intervention group engaged in more minutes of assigned activities than students randomized to the control. There was a significant difference in the change from pre- to post- intervention on measures of state anxiety and perceived stress, with better outcomes for the intervention group.
CONCLUSIONS


The assignment of twice-weekly wellness intervention sessions protects medical students from state anxiety and perceived stress with no negative impact on academic performance. Students adhered to the sessions and reported enjoying the sessions once trying them. Actual engagement is more important than wellness activity type.",2021,"There was a significant difference in the change from pre- to post- intervention on measures of state anxiety and perceived stress, with better outcomes for the intervention group.
",['Medical students participated in a 12-week randomized'],"['controlled intervention involving one-hour wellness sessions of either (1) yoga; (2) mindfulness; or (3) walking, held twice-weekly', 'wellness intervention']","['standardized psychological assessments', 'state anxiety and perceived stress']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0161254,"There was a significant difference in the change from pre- to post- intervention on measures of state anxiety and perceived stress, with better outcomes for the intervention group.
","[{'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Waechter', 'Affiliation': ""School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Stahl', 'Affiliation': 'Emergency Medicine, Brookdale University Hospital and Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rabie', 'Affiliation': ""Department of Educational Services, St. George's University, St. George, Grenada.""}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Colak', 'Affiliation': 'Westchester Medical Center/New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Debbi', 'Initials': 'D', 'LastName': 'Johnson-Rais', 'Affiliation': 'Division of Student Affairs and Enrollment Management, College of Science, Florida Atlantic University, Boca Raton, FL, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Landon', 'Affiliation': ""Psychological Services Center, School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Petersen', 'Affiliation': 'Global Medical Writing and Translation, Kent, WA, USA.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Davari', 'Affiliation': ""School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Thinn', 'Initials': 'T', 'LastName': 'Zaw', 'Affiliation': ""School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Kesava', 'Initials': 'K', 'LastName': 'Mandalaneni', 'Affiliation': ""School of Medicine, St. George's University, St. George, Grenada.""}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Punch', 'Affiliation': 'Windward Islands Research and Education Foundation, St. George, Grenada.'}]",Medical teacher,['10.1080/0142159X.2021.1902966']
155,33887514,D2 dissection improves disease-specific survival in advanced gastric cancer patients: 15-year follow-up results of the Italian Gastric Cancer Study Group D1 versus D2 randomised controlled trial.,"BACKGROUND


The extended lymphadenectomy (D2) was recently introduced in several guidelines as the optimal treatment for gastric cancer, based only on the 15-year follow-up results of the Dutch randomised trial, while the British Medical Research Council (MRC) study failed to demonstrate a survival benefit over the more limited D1 dissection. The Italian Gastric Cancer Study Group randomised controlled trial (RCT) was also undertaken to compare D1 versus D2 gastrectomy, and a tendency to improve survival in patients with advanced resectable disease (pT > 1N+) was documented despite negative results in the entire patient population. Now we present the 15-year follow-up results of survival and gastric cancer-related mortality.
METHODS


Between June 1998 and December 2006, eligible patients with gastric cancer who signed the informed consent were randomised at 5 centres to either D1 or D2 gastrectomy. Intraoperative randomisation was implemented centrally by phone call. Primary outcome was overall survival (OS); secondary end-points were disease-specific survival, postoperative morbidity and mortality. Analyses were by intention to treat. Strict quality control measures for surgery, lymph node removal, pathology and patient follow-up were implemented and monitored. Registration number: ISRCTN11154654 (http://www.controlled-trials.com).
FINDINGS


A total of 267 eligible patients were assigned to either D1 (133 patients) or D2 (134) procedure. Median follow-up time was 16.76 years. Analyses were done both in overall patient population and in pT > 1N+. One hundred patients (38.5) were alive without recurrence. OS and disease-specific survival (DSS) were very high in both arms. In overall population, they were not different between D1 and D2 arm (51.3% vs. 46.8% and 65% vs. 67% respectively, p = 0.31 and p = 0.94). DSS was significantly higher after D2 in pT > 1N+ patients (29.4% vs. 51.4%, p = 0.035). OS and DSS were better after D1 in patients older than 70 years (p = 0.003 and p = 0.006). DSS was higher after D1 also in early stages (p = 0.01).
INTERPRETATION


After 15-year follow up, despite no relevant difference in overall population, DSS and gastric cancer-related mortality of patients with advanced disease and lymph node metastases are improved by D2 procedure. Further data available from this trial suggest that D1 procedure should be preferably used in older patients and in early disease. As accurate detection of advanced diseases can be currently provided by adequate preoperative workup in referral centres, D2 procedure should be recommended in these cases.
FUNDING


Piedmont Regional fund for Finalized Healthy Research Project, Application 2003 for data collection.",2021,DSS was significantly higher after D2 in pT ,"['older patients and in early disease', 'advanced gastric cancer patients', 'Between June 1998 and December 2006, eligible patients with gastric cancer who\xa0signed the informed consent', 'patients with advanced resectable disease (pT\xa0>\xa01N', '267 eligible patients were assigned to either D1 (133 patients) or D2 (134) procedure']","['D1 versus D2 gastrectomy', 'D2 dissection', 'D1 or D2 gastrectomy']","['OS\xa0and disease-specific survival (DSS', 'disease-specific survival', 'overall survival (OS); secondary end-points were disease-specific survival, postoperative morbidity and mortality', 'alive without recurrence', 'OS and DSS', 'overall population, DSS and gastric cancer-related mortality', 'survival and gastric cancer-related mortality', 'DSS']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]",267.0,0.335666,DSS was significantly higher after D2 in pT ,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Degiuli', 'Affiliation': 'University of Turin, Department of Oncology, San Luigi University Hospital, Surgical Oncology and Digestive Surgery Unit, Regione Gonzole 10, Orbassano, Turin, 10043, Italy. Electronic address: maurizio.degiuli@unito.it.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Reddavid', 'Affiliation': 'University of Turin, Department of Oncology, San Luigi University Hospital, Surgical Oncology and Digestive Surgery Unit, Regione Gonzole 10, Orbassano, Turin, 10043, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tomatis', 'Affiliation': 'University of Turin, Department of Oncology, San Luigi University Hospital, Surgical Oncology and Digestive Surgery Unit, Regione Gonzole 10, Orbassano, Turin, 10043, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ponti', 'Affiliation': 'CPO Piemonte, AOU Città Della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morino', 'Affiliation': 'University of Turin, Department of Surgical Sciences, Turin, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sasako', 'Affiliation': 'Department of Surgery, Yodogawa Christian Hospital, Yodogawa, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.03.031']
156,33865836,"Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial.","BACKGROUND


Insulin detemir, being used increasingly during pregnancy, may have pharmacologic benefits compared with neutral protamine Hagedorn.
OBJECTIVE


We evaluated the probability that compared with treatment with neutral protamine Hagedorn, treatment with insulin detemir reduces the risk for adverse neonatal outcome among individuals with type 2 or overt type 2 diabetes mellitus (gestational diabetes mellitus diagnosed at <20 weeks' gestation).
STUDY DESIGN


We performed a multiclinic randomized controlled trial (September 2018 to January 2020), which included women with singleton gestation with type 2 or overt type 2 diabetes mellitus who sought obstetrical care at ≤21 weeks' gestation. Participants were randomized to receive either insulin detemir or neutral protamine Hagedorn by a clinic-stratified scheme. The primary outcome was a composite of adverse neonatal outcomes, including shoulder dystocia, large for gestational age, neonatal intensive care unit admission, respiratory distress (defined as the need of at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life), or hypoglycemia. The secondary neonatal outcomes included gestational age at delivery, small for gestational age, 5-minute Apgar score of <7, lowest glucose level, need for intravenous glucose, respiratory distress syndrome, need for mechanical ventilation or continuous positive airway pressure, neonatal jaundice requiring therapy, brachial plexus injury, and hospital length of stay. The secondary maternal outcomes included hypoglycemic events, hospital admission for glucose control, hypertensive disorder of pregnancy, maternal weight gain, cesarean delivery, and postpartum complications. We used the Bayesian statistics to estimate a sample size of 108 to have >75% probability of any reduction in the primary outcome, assuming 80% power and a hypothesized effect of 33% reduction with insulin detemir. All analyses were intent to treat under a Bayesian framework with neutral priors (a priori assumed a 50:50 likelihood of either intervention being better; National Clinical Trial identifier 03620890).
RESULTS


There were 108 women randomized in this trial (57 in insulin detemir and 51 in neutral protamine Hagedorn), and 103 women were available for analysis of the primary outcome (n=5 for pregnancy loss before 24 weeks' gestation). Bayesian analysis indicated an 87% posterior probability of reduced primary outcome with insulin detemir compared with neutral protamine Hagedorn (posterior adjusted relative risk, 0.88; 95% credible interval, 0.61-1.12). Bayesian analyses for secondary outcomes showed consistent findings of lower adverse maternal outcomes with the use of insulin detemir vs neutral protamine Hagedorn: for example, maternal hypoglycemic events (97% probability of benefit; posterior adjusted relative risk, 0.59; 95% credible interval, 0.29-1.08) and hypertensive disorders (88% probability of benefit; posterior adjusted relative risk, 0.81; 95% credible interval, 0.54-1.16).
CONCLUSION


In our comparative effectiveness trial involving individuals with type 2 or overt type 2 diabetes mellitus, use of insulin detemir resulted in lower rates of adverse neonatal and maternal outcomes compared with neutral protamine Hagedorn.",2021,Bayesian analyses for secondary outcomes showed consistent findings of lower adverse maternal outcomes with use of insulin,"['Diabetes Mellitus in Pregnancy', 'individuals with type 2 diabetes or overt type 2', '108 people randomized in this trial (57 insulin detemir; 51 NPH), and 103 were available for analysis of the primary outcome (N=5 for pregnancy loss before 24 wks', 'individuals with Type 2 diabetes mellitus or overt type 2 (gestational diabetes diagnosis <20 weeks', 'singleton gestation with Type 2 diabetes or overt type 2 who sought obstetrical care ≤21 weeks']","['insulin detemir', 'NPH', 'insulin', 'insulin detemir or NPH', 'Detemir versus Neutral Protamine Hagedorn Insulin']","['maternal hypoglycemic events', 'hypoglycemic events, hospital admission for glucose control, hypertensive disorder of pregnancy, maternal weight gain, cesarean delivery, and postpartum complications', 'composite of adverse neonatal outcomes including; shoulder dystocia, large for gestational age, neonatal intensive care unit admission, respiratory distress (defined as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life), or hypoglycemia', 'adverse maternal outcomes', 'adverse neonatal and maternal outcomes', 'hypertensive disorders', 'gestational age at delivery, small for gestational, 5-minute Apgar score <7, lowest glucose level, need for intravenous glucose, respiratory distress syndrome, need for mechanical ventilation or continuous positive airway pressure, neonatal jaundice requiring therapy, brachial plexus injury, and hospital length of stay']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0537270', 'cui_str': 'insulin detemir'}, {'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0537270', 'cui_str': 'insulin detemir'}, {'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021658', 'cui_str': 'insulin, isophane'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0269825', 'cui_str': 'Shoulder girdle dystocia'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0022353', 'cui_str': 'Neonatal jaundice'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0161446', 'cui_str': 'Injury of brachial plexus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",108.0,0.421838,Bayesian analyses for secondary outcomes showed consistent findings of lower adverse maternal outcomes with use of insulin,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Fishel Bartal', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX. Electronic address: Michal.f.bartal@uth.tmc.edu.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Ward', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Joycelyn A', 'Initials': 'JA', 'LastName': 'Ashby Cornthwaite', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Jerrie S', 'Initials': 'JS', 'LastName': 'Refuerzo', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Kyung Hyun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Center for Clinical Research and Evidence-Based Medicine, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.04.223']
157,33913784,Preventing internalising problems in preschoolers with chronic physical health conditions.,"This pilot study aimed to explore the suitability of a preventative intervention for internalising problems in young children with chronic physical health conditions. The pilot study focused on a subsample of 27 children with chronic physical health conditions within a population-level randomised controlled trial of the Cool Little Kids parenting programme. The Cool Little Kids parenting programme aims to prevent the development of internalising problems in inhibited (shy/anxious) preschool children by educating parents to reduce young children's avoidant coping styles and manage their anxiety/distress. The wider trial recruited 545 temperamentally inhibited preschool children. Measures included child health/development concerns and internalising symptoms at baseline, feedback on Cool Little Kids post-intervention and child internalising problems at one- and two-year longitudinal follow-up. At baseline, inhibited children with and without chronic physical health conditions had levels of internalising symptoms above the normative mean. At post-intervention, parents of children with chronic physical health conditions gave feedback that Cool Little Kids was helpful for managing their child's emotional distress. At follow-up, significantly fewer intervention than control children with chronic physical health conditions had specific phobia after 1 year (25% vs 70%) and specific fear symptoms after 2 years (mean 9.57 vs 16.89). As the pilot findings are promising, a further trial of Cool Little Kids in a physical health treatment service with a larger sample of children with chronic physical illness diagnoses would be worthwhile.",2022,"At follow-up, significantly fewer intervention than control children with chronic physical health conditions had specific phobia after 1 year (25% vs 70%) and specific fear symptoms after 2 years (mean 9.57 vs 16.89).","['27 children with chronic physical health conditions within a population-level randomised controlled trial of the Cool Little Kids parenting programme', 'young children with chronic physical health conditions', 'preschoolers with chronic physical health conditions', 'children with chronic physical illness diagnoses', '545 temperamentally inhibited preschool children']",['preventative intervention'],"['specific fear symptoms', 'child health/development concerns and internalising symptoms at baseline, feedback on Cool Little Kids post-intervention and child internalising problems', 'specific phobia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517809', 'cui_str': '545'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0455738', 'cui_str': 'Specific fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0236801', 'cui_str': 'Simple phobia'}]",545.0,0.0697647,"At follow-up, significantly fewer intervention than control children with chronic physical health conditions had specific phobia after 1 year (25% vs 70%) and specific fear symptoms after 2 years (mean 9.57 vs 16.89).","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'School of Psychology and Public Health, 2080La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Noone', 'Affiliation': 'School of Psychology and Public Health, 2080La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, 7788Macquarie University, Sydney, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kangas', 'Affiliation': 'Centre for Emotional Health, 7788Macquarie University, Sydney, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Anderson', 'Affiliation': ""34361Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Jordana K', 'Initials': 'JK', 'LastName': 'Bayer', 'Affiliation': 'School of Psychology and Public Health, 2080La Trobe University, Melbourne, Australia.'}]",Journal of child health care : for professionals working with children in the hospital and community,['10.1177/13674935211013192']
158,34338132,A randomized controlled trial of glycopyrrolate administered by metered dose inhaler in patients with uncontrolled asthma despite ICS/LABA treatment.,"OBJECTIVE


To evaluate the efficacy and safety of three doses of glycopyrrolate metered dose inhaler (GP MDI) in patients with uncontrolled asthma despite treatment with inhaled corticosteroid/long-acting β 2 -agonists (ICS/LABA) with or without tiotropium, to characterize the benefit of triple therapy.
METHOD


This phase II/III, double-blind study randomized patients to 24 weeks' treatment with twice-daily GP MDI 36 µg, 18 µg, 9 µg, or placebo MDI (all delivered  via  Aerosphere inhalers), or once-daily open-label tiotropium 2.5 µg. Patients continued their own ICS/LABA regimen throughout the study. The primary endpoint was change from baseline in forced expiratory volume in 1 s (FEV 1 ) area under the curve from 0 - 4 h (AUC 0 - 4 ) at Week 24. Secondary endpoints included patient questionnaires to measure asthma control or symptoms. Safety was also assessed.
RESULTS


The primary analysis (modified intent-to-treat) population included 1066 patients. The primary study endpoint was not met (changes from baseline in FEV 1  AUC 0 - 4  at Week 24 were 294 mL, 284 mL, 308 mL, 240 mL, and 347 mL for GP MDI 36 µg, GP MDI 18 µg, GP MDI 9 µg, placebo, and open-label tiotropium, respectively). There were no significant differences between treatment and placebo in secondary endpoints at Week 24.  Post-hoc  analyses using post-bronchodilator FEV 1  as the baseline measurement, or averaging values across multiple baseline visits, showed a dose-related response to GP MDI. The incidence of adverse events was low and similar across treatments.
CONCLUSION


Although this study did not meet its primary endpoint,  post hoc  analyses identified a dose-related response to GP MDI when alternative definitions of baseline FEV 1  were used in the analyses.",2022,"Although this study did not meet its primary endpoint,  post hoc  analyses identified a dose-related response to GP MDI when alternative definitions of baseline FEV 1  were used in the analyses.","['patients with uncontrolled asthma despite treatment with inhaled corticosteroid/long-acting β 2 -agonists (ICS/LABA) with or without', '1066 patients', 'patients with uncontrolled asthma despite ICS/LABA treatment']","['tiotropium', 'glycopyrrolate', 'twice-daily GP MDI 36\u2009µg, 18\u2009µg, 9\u2009µg, or placebo MDI (all delivered  via  Aerosphere inhalers), or once-daily open-label tiotropium 2.5\u2009µg', 'placebo', 'placebo, and open-label tiotropium', 'glycopyrrolate metered dose inhaler (GP MDI']","['efficacy and safety', 'adverse events', 'forced expiratory volume in 1\u2009s (FEV 1 ) area under the curve', 'patient questionnaires to measure asthma control or symptoms', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",1066.0,0.419044,"Although this study did not meet its primary endpoint,  post hoc  analyses identified a dose-related response to GP MDI when alternative definitions of baseline FEV 1  were used in the analyses.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, OR, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Rossman', 'Affiliation': 'Formerly of BioPharmaceuticals R&D, AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'Formerly of BioPharmaceuticals R&D, AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Maes', 'Affiliation': 'Formerly of Biopharmaceuticals R&D, AstraZeneca, Wilmington, DE, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Darken', 'Affiliation': 'Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Griffis', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Fjällbrant', 'Affiliation': 'Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2021.1938603']
159,34380586,Impact of educational programs on nurses' knowledge and attitude toward pediatric palliative care.,"OBJECTIVE


This study aims to assess the knowledge and attitude of nurses toward pediatric palliative care (PPC) and examine the impact of an educational program on pediatric nurses' knowledge and attitude regarding PPC for children facing life-threatening illnesses or chronic diseases in Jordan.
METHOD


A quasi-experimental design was used. Exactly 120 pediatric nurses participated in the study, of which 60 were in the intervention group and 60 in the control group.
RESULTS


The results of the study showed that nurses had a low score in knowledge and attitude toward PPC. The mean knowledge score of PPC for the control group is 6.88 (SD = 2.26), while that of the intervention group was 7.92 (SD = 1.99;  p  = 0.052). The mean attitude for PPC score for the control group was 95.88 (SD = 7.90), while that of the intervention group was 100 (SD = 10.95;  p  = 0.009). Also, the educational intervention had a significant positive effect on the knowledge and attitude toward PPC among nurses.
SIGNIFICANCE OF THE RESULTS


Based on the result of this study, the authors found strong evidence of the effectiveness of the PPC educational program when it came to improving the nurses' knowledge and attitude toward PPC services and offer us an effective educational program.",2022,"The mean attitude for PPC score for the control group was 95.88 (SD = 7.90), while that of the intervention group was 100 (SD = 10.95; p = 0.009).","['children facing life-threatening illnesses or chronic diseases in Jordan', '120 pediatric nurses participated in the study, of which 60 were in the intervention group and 60 in the control group', ""nurses' knowledge and attitude toward pediatric palliative care""]","['educational program', 'educational programs', 'PPC educational program', 'nurses toward pediatric palliative care (PPC']","['knowledge and attitude toward PPC', 'mean attitude for PPC score', 'mean knowledge score of PPC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0124733,"The mean attitude for PPC score for the control group was 95.88 (SD = 7.90), while that of the intervention group was 100 (SD = 10.95; p = 0.009).","[{'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Abuhammad', 'Affiliation': 'Department of Maternal and Child Health, Jordan University of Science and Technology/Faculty of Nursing, Irbid, Jordan.'}, {'ForeName': 'Ruaa', 'Initials': 'R', 'LastName': 'Almasri', 'Affiliation': 'Department of Maternal and Child Health, Jordan University of Science and Technology/Faculty of Nursing, Irbid, Jordan.'}]",Palliative & supportive care,['10.1017/S1478951521001139']
160,33856279,Supported Web-Based Acceptance and Commitment Therapy for Older Family Caregivers (CareACT) Compared to Usual Care.,"OBJECTIVES


The objective of the present study was to investigate whether an acceptance and commitment therapy (ACT)-based web-intervention (Group 1, CareACT), or a standardized rehabilitation in a rehabilitation center (Group 2) was effective in enhancing the psychological well-being of family caregivers aged 60 and over compared to support provided by voluntary caregiver associations (Group 3).
METHODS


Altogether, 149 family caregivers participated in this quasi-experimental study. Primary outcome measure was depression. Secondary outcomes included anxiety, sense of coherence, quality of life, psychological flexibility, experiential avoidance, and thought suppression. The questionnaires were administered at baseline, and four, and 10 months post-measurement. We investigated differences in the changes between the groups using Mplus modeling techniques.
RESULTS


Regarding the main outcome of depression, the results suggest that the CareACT intervention was superior to standardized rehabilitation and to the support given by caregiver associations at four months, both showing a medium-sized difference between the groups. However, the change from four to 10 months post-intervention was not significantly different between these groups (d = 0.32-0.36). Thought suppression showed a significantly different change between the three groups from baseline to four months and to 10 months post-measurement ( p  = .038).
CONCLUSIONS


Web-based ACT may have beneficial effects on depressive symptoms and thought suppression in older caregivers.
CLINICAL IMPLICATIONS


Web-based ACT could be a feasible alternative to institutional rehabilitation and support provided by voluntary caregiver associations. Web-based ACT respond s  flexibly to the needs of caregivers and provides them an opportunity for learning new skills to promote well-being.",2022,Thought suppression showed a significantly different change between the three groups from baseline to four months and to 10 months post-measurement ( p  = .038).,"['older caregivers', 'Older Family Caregivers (CareACT', '149 family caregivers participated in this quasi-experimental study']","['acceptance and commitment therapy (ACT)-based web-intervention (Group 1, CareACT), or a standardized rehabilitation in a rehabilitation center', 'CareACT intervention']","['depression', 'anxiety, sense of coherence, quality of life, psychological flexibility, experiential avoidance, and thought suppression']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",149.0,0.0919714,Thought suppression showed a significantly different change between the three groups from baseline to four months and to 10 months post-measurement ( p  = .038).,"[{'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Lappalainen', 'Affiliation': 'The Gerocenter Foundation for Research and Development, Jyväskylä, Finland.'}, {'ForeName': 'Inka', 'Initials': 'I', 'LastName': 'Pakkala', 'Affiliation': 'The Gerocenter Foundation for Research and Development, Jyväskylä, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Lappalainen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Nikander', 'Affiliation': 'The Gerocenter Foundation for Research and Development, Jyväskylä, Finland.'}]",Clinical gerontologist,['10.1080/07317115.2021.1912239']
161,33947979,Efficacy of montelukast in preventing seasonal recurrence of vernal keratoconjunctivitis in children.,"BACKGROUND


Vernal keratoconjunctivitis is a chronic, seasonally exacerbated, allergic inflammation of the eye. The study aims to evaluate the efficacy and safety of oral montelukast in treating vernal keratoconjunctivitis in pediatric patients.
METHODS


This is a 26-week, prospective, randomized, open-label study. Fifty-eight patients were randomly assigned to two groups-the treatment (montelukast) and control groups. At the beginning of the study, both the groups received topical loteprednol etabonate (0.1%) in tapering doses for a month, and topical olopatadine (0.1%) for the first 3 months. Symptoms and signs observed before and after treatment and assigned scores were studied. The primary efficacy endpoint was change in the mean score on the visual analog scale (VAS) for each subjective symptom. The secondary efficacy endpoint was change in the total score of objective signs.
RESULTS


The montelukast group showed clinically relevant improvements in the signs and symptoms of vernal keratoconjunctivitis, compared to the control group. There was considerable improvement in clinical signs. Individual symptoms such as redness, itching, foreign body sensation, and tearing showed significant improvement at 6 months follow-up. The gradual improvement in symptoms until the last visit was statistically more significant within montelukast group. Mean VAS score showed statistically significant improvement in itching (p < 0.001) and redness (p < 0.008) in montelukast group even at 3 months. No adverse events were reported in either group.
CONCLUSIONS


Montelukast was found to be safe and effective as a long-term therapy to prevent relapse in moderate to severe vernal keratoconjunctivitis.",2022,Mean VAS score showed statistically significant improvement in itching (p < 0.001) and redness (p < 0.008) in montelukast group even at 3 months.,"['pediatric patients', 'children', 'Fifty-eight patients']","['Montelukast', 'topical olopatadine', 'topical loteprednol etabonate', 'montelukast', 'oral montelukast']","['signs and symptoms of vernal keratoconjunctivitis', 'efficacy and safety', 'Mean VAS score', 'adverse events', 'itching', 'safe and effective', 'seasonal recurrence of vernal keratoconjunctivitis', 'clinical signs', 'mean score on the visual analog scale (VAS) for each subjective symptom', 'Individual symptoms such as redness, itching, foreign body sensation', 'total score of objective signs', 'redness']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0527189', 'cui_str': 'olopatadine'}, {'cui': 'C0126177', 'cui_str': 'loteprednol etabonate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0022577', 'cui_str': 'Vernal keratoconjunctivitis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",58.0,0.0377732,Mean VAS score showed statistically significant improvement in itching (p < 0.001) and redness (p < 0.008) in montelukast group even at 3 months.,"[{'ForeName': 'Apurva', 'Initials': 'A', 'LastName': 'Hardas', 'Affiliation': 'Cornea Unit, M & J Western Regional Institute of Ophthalmology, Ahmedabad, India.'}, {'ForeName': 'Neera', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Pro Cyto Labs Pvt. Ltd., KIIT-TBI, Campus 11, KIIT University, Bhubaneswar, India.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Mohanty', 'Affiliation': 'Cornea and Anterior Segment Services, MTC Campus, LV Prasad Eye Institute, Bhubaneswar, India.'}, {'ForeName': 'Srikant Kumar', 'Initials': 'SK', 'LastName': 'Sahu', 'Affiliation': 'Cornea and Anterior Segment Services, MTC Campus, LV Prasad Eye Institute, Bhubaneswar, India. srikantsahu@lvpei.org.'}]","Eye (London, England)",['10.1038/s41433-021-01484-3']
162,34343602,"The effect of rate and temperature on patient-reported pain during local anesthesia injection: A single-blinded, randomized, controlled trial.",,2022,,[],[],['Rate and Temperature on Patient-Reported Pain'],[],[],"[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.774967,,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Maisel-Campbell', 'Affiliation': 'Department of Dermatology, Columbia University Medical Center, New York, New York; Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weil', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jake M', 'Initials': 'JM', 'LastName': 'Lazaroff', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'M Laurin', 'Initials': 'ML', 'LastName': 'Council', 'Affiliation': 'Division of Dermatology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Eisen', 'Affiliation': 'Department of Dermatology, University of California Davis Medical System, Sacramento, California.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Lawrence', 'Affiliation': 'Division of Dermatology, Section of Procedural Dermatology, Cooper University Health Care, Marlton, New Jersey.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Minkis', 'Affiliation': 'Department of Dermatology, Weill Cornell/New York Presbyterian, New York, New York.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Bianca Y', 'Initials': 'BY', 'LastName': 'Kang', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Poon', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Murad', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Otolaryngology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. Electronic address: m-alam@northwestern.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.07.041']
163,33926288,The Importance of Baseline Word Reading Skills in Examining Student Response to a Multicomponent Reading Intervention.,"To address the needs of a diverse group of students with reading difficulties, a majority of researchers over the last decade have designed and implemented multicomponent reading interventions (MCRIs) that provide instruction in multiple areas of reading yielding mixed results. The current study evaluates whether students' baseline word reading skills predict their response to a MCRI. Data from a randomized controlled trial for third- and fourth-grade students with reading difficulties ( N  = 128) were analyzed. Results demonstrate that baseline word reading was a significant predictor of students' end-of-year reading comprehension performance. Treatment group students who had lower baseline word reading compared with those students with comparatively higher word reading scores performed significantly lower on posttest reading comprehension. Findings denote the importance of word reading instruction for upper elementary students who are below-average word readers and also indicate the need for tailoring reading intervention to align with individual reader needs.",2022,Treatment group students who had lower baseline word reading compared with those students with comparatively higher word reading scores performed significantly lower on posttest reading comprehension.,"['third- and fourth-grade students with reading difficulties ( N  = 128', 'upper elementary students who are below-average word readers']",[],"[""students' end-of-year reading comprehension performance""]","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0586742', 'cui_str': 'Difficulty reading'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",128.0,0.108526,Treatment group students who had lower baseline word reading compared with those students with comparatively higher word reading scores performed significantly lower on posttest reading comprehension.,"[{'ForeName': 'Johny', 'Initials': 'J', 'LastName': 'Daniel', 'Affiliation': 'Boston University, MA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Vaughn', 'Affiliation': 'The University of Texas at Austin, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'The University of Texas at Austin, USA.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Grills', 'Affiliation': 'Boston University, MA, USA.'}]",Journal of learning disabilities,['10.1177/00222194211010349']
164,33934120,Brain functional connectivity in children with developmental coordination disorder following rehabilitation intervention.,"BACKGROUND


Children with developmental coordination disorder (DCD) show improved motor function after Cognitive Orientation to Occupational Performance (CO-OP) intervention; however, the neural basis for these improvements is unknown.
METHODS


In this randomized waitlist-controlled trial, 78 children with DCD (with/without ADHD) were randomly assigned to either a treatment or waitlist group and underwent three resting-state MRI scans over six months. The treatment group received intervention between the first and second scan; the waitlist group received intervention between the second and third scan.
RESULTS


After CO-OP intervention, children with DCD [13 male, 8 female; mean (SD) age: 10.0 (1.7) years] showed increased functional connectivity between the default mode network and right anterior cingulate gyrus (p < 0.01). Additional gains were noted at follow-up three months after the intervention, with greater functional connectivity between the dorsal attention network and precentral gyrus (p < 0.02). However, children with DCD + ADHD [18 male, 1 female; mean (SD) age: 10.0 (1.14) years] did not show brain changes following CO-OP.
CONCLUSION


For children with DCD, increased functional connectivity in networks associated with self-, emotion-, and attention-regulation may underlie motor skill improvements observed after CO-OP intervention. Modifications to the CO-OP protocol may be required to induce similar brain changes in children with DCD + ADHD.
IMPACT


This study provides neuroscientific evidence for the Cognitive Orientation to Occupational Performance (CO-OP) approach as an effective rehabilitation intervention to induce brain and behavioral changes in children with DCD. While children with DCD ± ADHD showed improved motor function after CO-OP, only children with DCD showed brain changes after intervention. Children with DCD showed increased functional connectivity in networks associated with self-, emotion-, and attention-regulation after the intervention. Treatment modifications may be required to induce similar brain changes in children with DCD + ADHD. Pediatricians are encouraged to refer children with DCD  with and without ADHD for CO-OP intervention to improve their motor skills.",2022,"Additional gains were noted at follow-up three months after the intervention, with greater functional connectivity between the dorsal attention network and precentral gyrus (p < 0.02).","['children with DCD', 'children with DCD\u2009+\u2009ADHD [18 male, 1 female; mean (SD) age: 10.0 (1.14) years', 'children with DCD\u2009+\u2009ADHD', '78 children with DCD (with/without ADHD', 'children with developmental coordination disorder following rehabilitation intervention', 'children with DCD [13 male, 8 female; mean (SD) age: 10.0 (1.7) years', 'Children with developmental coordination disorder (DCD']","['waitlist group and underwent three resting-state MRI scans', 'waitlist group received intervention between the second and third scan']","['functional connectivity in networks associated with self-, emotion-, and attention-regulation', 'motor function', 'brain changes', 'functional connectivity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517492', 'cui_str': '1.14'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",78.0,0.0388743,"Additional gains were noted at follow-up three months after the intervention, with greater functional connectivity between the dorsal attention network and precentral gyrus (p < 0.02).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Izadi-Najafabadi', 'Affiliation': 'Graduate Programs in Rehabilitation Sciences, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Shie', 'Initials': 'S', 'LastName': 'Rinat', 'Affiliation': 'Graduate Programs in Rehabilitation Sciences, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jill G', 'Initials': 'JG', 'LastName': 'Zwicker', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, Canada. jill.zwicker@ubc.ca.""}]",Pediatric research,['10.1038/s41390-021-01517-3']
165,33941032,Clinical and economic impact of telemedicine in the management of pediatric asthma in Jordan: a pharmacist-led intervention.,"OBJECTIVE


Pediatric asthma is a major public health concern, considering its chronic nature and negative effects on quality of life of affected children. Telemedicine is efficacious in providing pharmaceutical care for patients with several chronic diseases, including asthma. This approach allows habitants of sparsely populated rural Jordanian areas to remotely access high-quality healthcare services. Pharmacist-provided asthma counseling has proven benefits in improving patient adherence rates and their understanding. This study evaluated clinical and economic impacts of pharmacist-led, interactive synchronous telemedicine counseling of pediatric asthma patients in Jordan.
METHODS


A randomized, controlled, 12-week pre-post interventional study was conducted. Ninety patients with uncontrolled asthma aged 5-11 years were recruited and randomly assigned to two groups: intervention or control. Inhaler use was checked for both groups at baseline, along with assessment of clinical and economic measures. Counseling on proper inhaler use was provided by pharmacists. Telemedicine sessions for the intervention group were scheduled every 4 weeks, whereas the control group received standard care. Pertinent measures reflecting the level of disease control and relapse were tracked monthly.
RESULTS


The intervention group showed more significant improvement in clinical and economic outcomes than the control group (the Childhood Asthma Control Test mean scores [ P  = 0.0134], decreased parental loss of wages [ P  = 0.0015], and decreased economic burden [ P  < 0.001]). Additionally, overall improvement in quality of life and satisfaction with the telemedicine sessions were reported.
CONCLUSION


Pharmacist-led telemedicine counseling could be a promising approach to deliver distant pharmaceutical care for patients with childhood asthma.",2022,"The intervention group showed more significant improvement in clinical and economic outcomes than the control group (the Childhood Asthma Control Test mean scores [P = 0.0134], decreased parental loss of wages [P = 0.0015], and decreased economic burden [P < 0.001]).","['pediatric asthma in Jordan', 'patients with several chronic diseases, including asthma', 'pediatric asthma patients in Jordan', 'Ninety patients with uncontrolled asthma aged 5-11 years', 'patients with childhood asthma']","['control group received standard care', 'Telemedicine sessions', 'telemedicine', 'Telemedicine', 'telemedicine counseling', 'pharmacist-led, interactive synchronous telemedicine counseling', 'intervention or control']","['clinical and economic outcomes', 'parental loss of wages', 'level of disease control and relapse', 'quality of life and satisfaction']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036064', 'cui_str': 'Salaries'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",90.0,0.014957,"The intervention group showed more significant improvement in clinical and economic outcomes than the control group (the Childhood Asthma Control Test mean scores [P = 0.0134], decreased parental loss of wages [P = 0.0015], and decreased economic burden [P < 0.001]).","[{'ForeName': ""Mu'min Billah M"", 'Initials': 'MBM', 'LastName': 'Shdaifat', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Rawand A', 'Initials': 'RA', 'LastName': 'Khasawneh', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Qais', 'Initials': 'Q', 'LastName': 'Alefan', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2021.1924774']
166,33955318,Effectiveness of Acceptance and Commitment Therapy (ACT) in Professional Dementia Caregivers Burnout.,"OBJECTIVES


To implement and assess the efficacy of a 6-week Acceptance and Commitment Therapy intervention to reduce anxiety and burnout in healthcare professionals working with dementia, and to increase their psychological flexibility and life satisfaction.
METHODS


A total of 105 workers from the CSSV Ricard Fortuny Hospital were randomly assigned to an intervention group (Acceptance and Commitment Therapy) or a wait list control group. Psychological Flexibility (AAQ-II), Life Satisfaction (SWLS), Anxiety (STAI-T), and Burnout (MBI) were measured before and after the intervention. Follow-up data were collected 3 months and 12 months post-intervention. Split-plot analyses were performed following intention to treat approach.
RESULTS


No significant differences were found in baseline outcome measures. No time effects were found in wait list control group in any variable. In the intervention group, pre-post comparison showed a significant decrease in levels of MBI emotional exhaustion ( p  = .001) and anxiety ( p  < .001), and an increase in life satisfaction levels ( p  < .001) and MBI personal accomplishment ( p  < .001). These results were maintained at the 3- and 12-month follow-up periods. No significant intervention effects were observed in pre-post flexibility scores; however, data suggest slight progressive increase in flexibility at follow-up.
CONCLUSIONS


Acceptance and Commitment Therapy showed positive effects in healthcare professionals working with dementia by reducing anxiety and burnout.
CLINICAL IMPLICATIONS


The implementation of Acceptance and Commitment Therapy could help to increase the psychological well-being of healthcare professionals working with dementia.",2022,"No significant intervention effects were observed in pre-post flexibility scores; however, data suggest slight progressive increase in flexibility at follow-up.","['A total of 105 workers from the XXXXX Hospital', 'Professional Dementia Caregivers Burnout']","['Acceptance and Commitment Therapy (ACT', 'intervention group (Acceptance and Commitment Therapy) or a wait list control group', 'Acceptance and Commitment Therapy intervention']","['life satisfaction levels', 'flexibility', 'MBI personal accomplishment', 'anxiety', 'Psychological Flexibility (AAQ-II), Life Satisfaction (SWLS), Anxiety (STAI-T), and Burnout (MBI', 'levels of MBI emotional exhaustion', 'psychological flexibility and life satisfaction']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4704714', 'cui_str': 'Caregiver Burnout'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0045870', 'cui_str': '2-aminoanthraquinone'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",105.0,0.0187588,"No significant intervention effects were observed in pre-post flexibility scores; however, data suggest slight progressive increase in flexibility at follow-up.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montaner', 'Affiliation': 'Centre Sociosanitari Ricard Fortuny, Vilafranca del Penedes, Spain.'}, {'ForeName': 'Salomé', 'Initials': 'S', 'LastName': 'Tárrega', 'Affiliation': 'Universitat de Vic - Universitat Central de Catalunya, Vic, Spain.'}, {'ForeName': 'Melodie', 'Initials': 'M', 'LastName': 'Pulgarin', 'Affiliation': 'Centre Sociosanitari Ricard Fortuny, Vilafranca del Penedes, Spain.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Moix', 'Affiliation': 'Universitat Autònoma de Barcelona Facultat de Psicologia, Bellaterra, Spain.'}]",Clinical gerontologist,['10.1080/07317115.2021.1920530']
167,33947827,Multidisciplinary program based on early management of psychological factors reduces disability of patients with subacute low back pain: one-year results of a randomized controlled study.,"BACKGROUND


Multidisciplinary rehabilitation induces disability improvement, pain reduction and favors return-to-work in patients with subacute low back pain (LBP). Current research advises additional high-quality trials.
AIM


The aim of this study is to test the effect of a multidisciplinary rehabilitative program incorporating cognitive-behavioral interventions compared to general physiotherapy alone to treat subacute LBP, and to appraise its long-term extent.
DESIGN


Randomised parallel-group superiority-controlled trial.
SETTING


Outpatient rehabilitation hospital.
POPULATION


One hundred and fifty patients with subacute LBP.
METHODS


Patients were assigned randomly to a 10-week individual-based multimodal program of task-oriented exercises integrated with cognitive-behavioral therapy (experimental group, 75 patients) or individual-based general physiotherapy (control group, 75 patients). Before treatment, 10 weeks later (post-treatment), and 12 months after treatment, the staff administered the Oswestry Disability Index (ODI, primary outcome), a pain intensity numerical rating scale (NRS), the Tampa Scale for Kinesiophobia (TSK), the Pain Beliefs and Perception Inventory (PBAPI), the Hospital and Anxiety Depression Score (HADS) and the Coping Strategies Questionnaire-revised (CSQ-R). Linear mixed model analysis for repeated measures was carried out for each outcome measure.
RESULTS


Significant group (P<0.001), time (P=0.002), and time-by-group interaction (P<0.001) effects were found for ODI, with a between-group difference (standard error) after training of 11.5 (1.0) and at follow-up of 15.7 (0.9), in favor of the experimental group. A significant interaction effect (P<0.001) was found for all secondary outcome measures, with significantly greater improvements in the experimental group, after rehabilitation and at follow-up.
CONCLUSIONS


The multidisciplinary intervention was superior to general physiotherapy in reducing disability, pain, psychological factors and coping strategies of patients with subacute LBP. The effects were reinforced after one year.
CLINICAL REHABILITATION IMPACT


Treatment of subacute LBP requires cognitive modifications closely linked to physical performances in order to achieve mental adjustments and guarantee cognitive-behavioral and motor lasting changes.",2021,"The multidisciplinary intervention was superior to general physiotherapy in reducing disability, pain, psychological factors and coping strategies of patients with subacute LBP.","['Patients', 'patients with subacute low back pain (LBP', 'Outpatient rehabilitation hospital', 'patients with subacute LBP', '150 patients with subacute LBP', 'patients with subacute low back pain']","['multidisciplinary rehabilitative programme incorporating cognitivebehavioural interventions', 'multidisciplinary intervention was superior to general physiotherapy', '10-week individual-based multimodal programme of task-oriented exercises integrated with cognitive-behavioural therapy (experimental group, 75 patients) or individual-based general physiotherapy (control']","['Oswestry Disability Index (ODI, primary outcome), a pain intensity numerical rating scale (NRS), the Tampa Scale for Kinesiophobia', 'disability, pain, psychological factors and coping strategies', 'disability improvement, pain reduction', 'TSK), the Pain Beliefs and Perception Inventory (PBAPI), the Hospital and Anxiety Depression Score (HADS) and the Coping Strategies Questionnaire-revised (CSQ-R']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",150.0,0.0358283,"The multidisciplinary intervention was superior to general physiotherapy in reducing disability, pain, psychological factors and coping strategies of patients with subacute LBP.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Monticone', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy - marco.monticone@unica.it.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Ambrosini', 'Affiliation': 'Laboratory of Neuroengineering and Medical Robotics, Department of Electronics, Information and Bioengineering, Polytechnic University Milano, Milan, Italy.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Portoghese', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rocca', 'Affiliation': 'Unit of Physical Medicine and Rehabilitation, Scientific Institute of Lissone, Maugeri Clinical and Scientific Institutes, Lissone, Monza Brianza, Italy.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.21.06696-X']
168,33956056,"Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus.","OBJECTIVE


To evaluate the dose-response, efficacy and safety of dapirolizumab pegol (DZP) in patients with SLE.
METHODS


Adults with moderately to severely active SLE (SLEDAI-2K score ≥6 and ≥1 BILAG A or ≥2 BILAG B domain scores), receiving stable CS (≤40 mg/day prednisone-equivalent), antimalarial or immunosuppressant drugs were included. Patients with stable LN (proteinuria ≤2 g/day) not receiving high-dose CS or CYC were permitted entry. Randomized patients received placebo or i.v. DZP (6/24/45 mg/kg) and standard-of-care (SOC) treatment every 4 weeks to week 24, after which patients received only SOC to week 48. The primary objective was to establish a dose-response relationship based on week 24 BILAG-Based Composite Lupus Assessment (BICLA) responder rates.
RESULTS


All DZP groups exhibited improvements in clinical and immunological outcomes vs placebo at week 24; however, BICLA responder rates did not fit pre-specified dose-response models [best-fitting model (Emax): P = 0.07]. Incidences of serious treatment-emergent adverse events across DZP groups were low and similar to placebo. Following DZP withdrawal, SLEDAI-2K, physician's global assessment (PGA), BILAG, and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scores stabilized; BICLA and SLE Responder Index (SRI-4) responder rates declined (likely due to interventions with disallowed escape medications), BILAG flares increased, and immunologic parameters returned towards baseline.
CONCLUSIONS


Although the primary objective was not met, DZP appeared to be well tolerated, and patients exhibited improvements across multiple clinical and immunological measures of disease activity after 24 weeks relative to placebo. The potential clinical benefit of DZP warrants further investigation.",2021,Incidences of serious treatment-emergent adverse events across DZP groups were low and similar to placebo.,"['Patients with Moderate-to-Severe Active Systemic Lupus Erythematosus', 'Patients with stable lupus nephritis (proteinuria ≤2\u2009g/day) not receiving high-dose corticosteroids or', 'Adults with moderately to severely active SLE (SLEDAI-2K score ≥6 and ≥1 BILAG A or\u2009≥\u20092 BILAG B domain scores), receiving', 'patients with systemic lupus erythematosus (SLE']","['cyclophosphamide', 'stable corticosteroid (≤40\u2009mg/day prednisone-equivalent), antimalarial, or immunosuppressant drugs', 'Placebo', 'Dapirolizumab Pegol', 'DZP', 'placebo or intravenous DZP', 'placebo', 'dapirolizumab pegol (DZP']","['disease activity', ""SLEDAI-2K, physician's global assessment (PGA), BILAG, and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scores stabilized; BICLA and SLE Responder Index (SRI-4) responder rates"", 'dose-response relationship based on week 24 BILAG-Based Composite Lupus Assessment (BICLA) responder rates', 'BICLA responder rates', 'clinical and immunological outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4548277', 'cui_str': 'dapirolizumab pegol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0024137', 'cui_str': 'Cutaneous lupus erythematosus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.227442,Incidences of serious treatment-emergent adverse events across DZP groups were low and similar to placebo.,"[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Northwell Health, Great Neck, NY, USA.'}, {'ForeName': 'Ian N', 'Initials': 'IN', 'LastName': 'Bruce', 'Affiliation': 'NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Trust.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dörner', 'Affiliation': 'Charité Berlin, Berlin, Germany.'}, {'ForeName': 'Manuel Gustavo', 'Initials': 'MG', 'LastName': 'Leon', 'Affiliation': 'Investigaciones Clínicas, Lima, Peru.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Leszczyński', 'Affiliation': 'Poznań University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Urowitz', 'Affiliation': 'Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Haier', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Jimenez', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Brittain', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Barbey', 'Affiliation': 'Biogen, Baar, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stach', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keab381']
169,33958719,Infant formula containing bovine milk-derived oligosaccharides supports age-appropriate growth and improves stooling pattern.,"BACKGROUND


Adding bovine milk-derived oligosaccharides (MOS) enhances the oligosaccharide profile of infant formula. This study aimed to evaluate the safety and efficacy of a MOS-supplemented infant formula.
METHODS


In this double-blind randomized controlled trial, healthy infants 21-26 days old were either assigned to bovine milk-based, alpha-lactalbumin, and sn-2 palmitate enriched infant formula (control, n = 115) or the same formula with 7.2 g MOS/L (test, n = 115) until aged 6 months. Co-primary endpoints were weight gain through 4 months and stool consistency (validated scale: 1 = watery to 5 = hard). Secondary endpoints included parent-reported GI tolerance, health-related quality of life (HRQoL), and adverse events (AEs).
RESULTS


Weight gain was similar (p = 0.695); the difference between test and control (mean; 95% CI: 0.29; -1.15, 1.73 g/day) was above the non-inferiority margin (-3 g/day). Test had softer stools than control (mean difference in stool consistency score: -0.31; 95% CI: -0.42, -0.21; P < 0.0001); fewer parental reports of harder stools (OR = 0.32, 95% CI: 0.20, 0.49; P < 0.0001) and less difficulties in passing stool (OR = 0.25, 95% CI: 0.09, 0.65; P = 0.005). Parent-reported GI tolerance and HRQoL were similar between groups as were the overall low AEs.
CONCLUSIONS


MOS-supplemented infant formula is safe and well-tolerated while supporting normal infant growth and promotes softer stooling pattern without increasing parent-reported and physician-confirmed adverse health concerns.
IMPACT


This is the first study investigating the addition of bovine milk-derived oligosaccharides to an infant formula enriched with alpha-lactalbumin and elevated levels of sn-2 palmitate, providing safety and efficacy data for such a formula. Term infant formula supplemented with 7.2 g bovine milk-derived oligosaccharides per liter supported normal infant growth, was well-tolerated and safe. Addition of bovine milk-derived oligosaccharides to term infant formula promoted softer stooling pattern and reduced difficulties in passing stool. The study shows that bovine milk-derived oligosaccharide supplemented infant formula is a safe and effective option for healthy term infants who are formula-fed.",2022,"RESULTS


Weight gain was similar (p = 0.695); the difference between test and control (mean; 95% CI: 0.29; -1.15, 1.73 g/day) was above the non-inferiority margin (-3 g/day).","['healthy term infants who are formula-fed', 'healthy infants 21-26 days old']","['bovine milk-derived oligosaccharides', 'bovine milk-derived oligosaccharides (MOS', 'MOS-supplemented infant formula', 'bovine milk-derived oligosaccharide supplemented infant formula', 'bovine milk-based, alpha-lactalbumin, and sn-2 palmitate enriched infant formula (control, n\u2009=\u2009115) or the same formula with 7.2\u2009g\xa0MOS/L']","['parent-reported GI tolerance, health-related quality of life (HRQoL), and adverse events (AEs', 'safety and efficacy', 'stool consistency score', 'tolerated and safe', 'Weight gain', 'GI tolerance and HRQoL', 'weight gain through 4 months and stool consistency']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002287', 'cui_str': 'Alpha-lactalbumin'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4517857', 'cui_str': '7.2'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.240031,"RESULTS


Weight gain was similar (p = 0.695); the difference between test and control (mean; 95% CI: 0.29; -1.15, 1.73 g/day) was above the non-inferiority margin (-3 g/day).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Estorninos', 'Affiliation': 'Asian Hospital and Medical Center, Muntinlupa City, Philippines.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Lawenko', 'Affiliation': 'Asian Hospital and Medical Center, Muntinlupa City, Philippines.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Palestroque', 'Affiliation': 'Asian Hospital and Medical Center, Muntinlupa City, Philippines.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lebumfacil', 'Affiliation': 'Wyeth Nutrition, Makati City, Manila, Philippines.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marko', 'Affiliation': 'Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland.'}, {'ForeName': 'C I', 'Initials': 'CI', 'LastName': 'Cercamondi', 'Affiliation': 'Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland. ColinIvano.Cercamondi@nestle.com.'}]",Pediatric research,['10.1038/s41390-021-01541-3']
170,34486580,Clinical outcomes of transepithelial photorefractive keratectomy with epithelial ablation targeting actual epithelial thickness vs default laser platform values.,"PURPOSE


To investigate the clinical outcomes of transepithelial photorefractive keratectomy (tPRK) with actual epithelial thickness vs default software values.
SETTING


Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
DESIGN


Prospective controlled study.
METHODS


Patients with refractive spherical error of -1.50 to -7.00 diopters (D) and refractive astigmatism up to 4.00 D were consecutively enrolled and divided into 2 groups: group 1 undergone tPRK with actual central and peripheral epithelial thickness input in right eyes, group 2 undergone tPRK with actual central and 10 mm higher peripheral epithelial thickness in right eyes. Left eyes in both groups underwent tPRK with default protocol. Outcome measures were induced refractive error, achieved optical zone (OZ), and wasted stromal tissue.
RESULTS


83 patients were included in this study. Mean ± SD of induced spherical equivalent was +0.15 ± 0.39 D and +0.01 ± 0.35 D in right and left eyes of group 1 (P = .01) and +0.04 ± 0.22 D and +0.03 ± 0.23 D in right and left eyes of group 2 (P = .75), respectively. There was no statistically significant difference between wasted tissue between right and left eyes in group 1 and group 2 (P = .77 and P = .49, respectively). OZ contraction was significantly higher in right compared with left eyes in group 1 (P = .05), but not in group 2 (P = .95).
CONCLUSIONS


In tPRK, refractive outcomes, wasted tissue, and OZ contraction depend little on preexisting corneal epithelial thickness in corneas with normal range epithelial thickness. However, OZ contraction may be a concern in lower amount of ablations.",2022,"There was no statistically significant difference between wasted tissue between right and left eyes in group 1 and group 2 (p=0.77 and p=0.49, respectively).","['eighty-three patients with refractive spherical error of -1.50 to -7.00 diopters (D), and refractive astigmatism up to 4.00 D', 'Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, IranDesign']","['transepithelial PRK using SCHWIND AMARIS laser platform', 'tPRK with actual central and peripheral epithelial thickness input in right eyes, group 2 undergone tPRK with actual central and 10 μm higher peripheral epithelial thickness in right eyes, left eyes underwent tPRK with default protocol', 'transepithelial photorefractive keratectomy (tPRK']","['tPRK, refractive outcomes, wasted tissue, and OZ contraction depend little on pre-existing corneal epithelial thickness', 'OZ contraction', 'Mean ± SD of induced spherical equivalent (SE', 'induced refractive error, achieved optical zone (OZ), and wasted stromal tissue']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0022772', 'cui_str': ""Democratic people's republic of Korea""}, {'cui': 'C2714641', 'cui_str': 'Amaris'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}]",83.0,0.0292939,"There was no statistically significant difference between wasted tissue between right and left eyes in group 1 and group 2 (p=0.77 and p=0.49, respectively).","[{'ForeName': 'Mohammad Naser', 'Initials': 'MN', 'LastName': 'Hashemian', 'Affiliation': 'From the Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Faegh', 'Affiliation': ''}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Latifi', 'Affiliation': ''}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Abdi', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000803']
171,34024738,Does increased patient comprehension decrease preoperative anxiety before digestive surgery?,"BACKGROUND


There exists a misalignment between the information given by a surgeon and the information retained by the patient. Inability to assimilate relevant information can be a factor of preoperative anxiety. The aim of this study was to assess patients' information retention according to a Fédération de Chirurgie Viscérale et Digestive (FCVD) questionnaire.
MATERIALS


From 29 June 2020 to 2 August 2020, a prospective, comparative multicenter study was conducted among 89 patients who were about to undergo digestive surgery. They were included either in a standard group (management in accordance with the usual French guidelines) or experimental group, which received a second consultation, one week before surgery. The day before being operated, all the patients filled out 3 questionnaires analyzing their percentage of retention according to two scales: the Amsterdam Preoperative Anxiety and information Scale (APAIS) and the visual analogue scale for anxiety (VAS-A).
RESULTS


Patient comprehension of the FCVD information was 94% and 63% in the experimental and the control groups, respectively (P<0.001). The standard group was significantly more anxious than the experimental group, with VAS-A rates of 6.2 and 4.6 (P=0.014), respectively. On the other hand, according to the APAIS scale, they were similarly anxious, with scores of 11.3 versus 11.9, respectively (P=0.200).
CONCLUSION


A second transmission of exhaustive information shortly before digestive surgery was conducive to improved retention. Enhanced comprehension and memorization reduced preoperative anxiety.",2022,"The standard group was significantly more anxious than the experimental group, with VAS-A rates of 6.2 and 4.6 (P=0.014), respectively.","['From 29 June 2020 to 2 August 2020', ""patients' information retention according to a Fédération de Chirurgie Viscérale et Digestive (FCVD) questionnaire"", '89 patients who were about to undergo digestive surgery']",[],"['Enhanced comprehension and memorization reduced preoperative anxiety', 'FCVD information', 'Amsterdam Preoperative Anxiety and information Scale (APAIS) and the visual analogue scale for anxiety (VAS-A', 'anxious']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3874886', 'cui_str': 'Is about'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",89.0,0.00759784,"The standard group was significantly more anxious than the experimental group, with VAS-A rates of 6.2 and 4.6 (P=0.014), respectively.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bounif', 'Affiliation': 'Visceral Surgery Department, Limoges University Hospital, Limoges, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ducos', 'Affiliation': 'Visceral Surgery Department, Limoges University Hospital, Limoges, France; Visceral Surgery Department, Saint-Junien Hospital, 87200, Saint-Junien, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Appourchaux', 'Affiliation': 'Visceral Surgery Department, Limoges University Hospital, Limoges, France; Visceral Surgery Department, Brive-la-Gaillarde Hospital, 19000, Brive La Gaillarde, France.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Ferrero', 'Affiliation': 'Visceral Surgery Department, Limoges University Hospital, Limoges, France; Visceral Surgery Department, Brive-la-Gaillarde Hospital, 19000, Brive La Gaillarde, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roux', 'Affiliation': 'Visceral Surgery Department, Limoges University Hospital, Limoges, France; Visceral Surgery Department, Saint-Junien Hospital, 87200, Saint-Junien, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mathonnet', 'Affiliation': 'Visceral Surgery Department, Limoges University Hospital, Limoges, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Taibi', 'Affiliation': 'Visceral Surgery Department, Limoges University Hospital, Limoges, France; Visceral Surgery Department, Saint-Junien Hospital, 87200, Saint-Junien, France; University Limoges, CNRS, XLIM, UMR 7252, 87000 Limoges, France. Electronic address: abdelkader.taibi@hotmail.fr.'}]",Journal of visceral surgery,['10.1016/j.jviscsurg.2021.02.009']
172,34053249,"Efficacy of whole-body vibration on balance control, postural stability, and mobility after thermal burn injuries: A prospective randomized controlled trial.","OBJECTIVE


To investigate the additive effects of whole-body vibration (WBV) training to the traditional physical therapy program (TPTP) on balance control, postural stability, and mobility after thermal burn injuries.
DESIGN


A single-blinded, randomized controlled study.
SETTING


Outpatient physical therapy setting.
PARTICIPANTS


Forty participants, 20-45 years old, with deep second-degree thermal burn involving the lower limbs and trunk, with 35%-40% total body service area, were randomly allocated either into the study group or the control group.
INTERVENTION


The study group received WBV plus TPTP while the control group received the TPTP only. Interventions were applied three sessions a week for eight weeks.
OUTCOME MEASURES


Anteroposterior stability index (APSI), mediolateral stability index (MLSI), overall stability index (OSI), timed-up and go (TUG), and Berg balance scale (BBS) were measured at baseline and after eight weeks of interventions.
RESULTS


There were statistically significant differences in APSI, MLSI, OSI, BBS, and TUG in favor of the WBV group after eight weeks of intervention ( P  < 0.001). After eight weeks of intervention, the mean (SD) for APSI, MLSI, OSI, BBS, and TUG scores were 1.87 ± 0.51, 41.36 ± 0.18, 1.95 ± 0.56, 47.2 ± 6.12, and 8.15 ± 1.05 seconds in the WBV group, and 2.41 ± 0.71, 2.21 ± 0.54, 2.68 ± 0.73, 40.65 ± 4.7, and 10.95 ± 2.44 seconds in the control group, respectively.
CONCLUSIONS


The whole-body vibration training combined with the TPTP was more beneficial in improving APS, MLS, OSI, TUG, and BBS than TPTP alone. It might be considered a useful adjunctive therapy in treating patients with healed wounds with a deep second-degree burn of the trunk and lower limbs.",2021,"The whole-body vibration training combined with the TPTP was more beneficial in improving APS, MLS, OSI, TUG, and BBS than TPTP alone.","['Forty participants, 20-45\u2009years old, with deep second-degree thermal burn involving the lower limbs and trunk, with 35%-40% total body service area', 'Outpatient physical therapy setting', 'after thermal burn injuries', 'patients with healed wounds with a deep second-degree burn of the trunk and lower limbs']","['whole-body vibration', 'WBV) training to the traditional physical therapy program (TPTP', 'TPTP', 'WBV plus TPTP']","['APSI, MLSI, OSI, BBS, and TUG', 'balance control, postural stability, and mobility', 'APS, MLS, OSI, TUG, and BBS', 'Anteroposterior stability index (APSI), mediolateral stability index (MLSI), overall stability index (OSI), timed-up and go (TUG), and Berg balance scale (BBS', 'mean (SD) for APSI, MLSI, OSI, BBS, and TUG scores']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0443298', 'cui_str': 'Second degree'}, {'cui': 'C0701836', 'cui_str': 'Thermal burn'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0433405', 'cui_str': 'Deep partial thickness burn'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0545511,"The whole-body vibration training combined with the TPTP was more beneficial in improving APS, MLS, OSI, TUG, and BBS than TPTP alone.","[{'ForeName': 'Nabil Mahmoud', 'Initials': 'NM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Department of Physical Therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Nesma M', 'Initials': 'NM', 'LastName': 'Allam', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Hadaya Mosaad', 'Initials': 'HM', 'LastName': 'Eladl', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Clinical rehabilitation,['10.1177/02692155211020861']
173,34464302,Comparison of systemic inflammatory responses of proximal femoral nail versus dynamic hip screw after treatment of patients with pertrochanteric fractures: A prospective comparative study.,"OBJECTIVE


The aim of this study was to investigate the differences between the induction of early postoperative inflammatory response and muscle tissue injury biomarkers after treatment of pertrochanteric fractures by dynamic hip screw (DHS) or proximal femoral nail (PFN).
METHODS


In this prospective comparative study, 40 patients with AO-Müller/Orthopaedic Trauma Association (AO/OTA) 31. A1-31.A2 pertrochanteric fractures were enrolled and allocated one of the two groups based on the treatment type: group DHS, (n =20,mean age = 78.4 ± 6.9 years) and group PFN (n = 20, mean age = 77.75 ± 7.0 years). Operation time was recorded in both groups. In each patient, circulating levels of high sensitivity interleukin-6 (hs-IL-6), C-reactive protein (CRP), and creatine kinase (CK), and erythrocyte sedimentation rate (ESR)weremeasured fromblood samples collected 1 hour preoperatively and 24 hours postoperatively.
RESULTS


The operation time was slightly shorter in group PFN than in group DHS (51.9 ± 21.1 and 38 ± 15.2 min, respectively; P = 0.02). DHS and PFN both increased hs-IL-6 (143.81 ± 89.12 and 94.13 ± 67.14, respectively), CRP (98.84 ± 31.81 and 104.4 ± 31.80, respectively), and CK (400.8 ± 31.81 and 250.7 ± 31.80, respectively) 24 hours postoperatively. However, PFN compared to DHS resulted in a lesser increase from baseline to 24 hours postoperatively only in hs IL-6 (58.91 ± 59.02 vs 113.30 ± 76.24, respectively; P = 0.0016) and CK (163.6 ± 123.3 vs 310.0 ± 198.3, respectively; P < 0.0001).Moreover, there was a positive correlation of CK levels' surgery time in DHS (r = 0.38, P = 0.0065) and PFN (r = 0.45, P = 0.0013).
CONCLUSION


The results of this study have shown that PFN can induce a lower early postoperative inflammatory response and muscle tissue injury based on the assessment of hs-IL-6 and CK levels, compared to DHS in after the treatment patients pertrochanteric fractures.
LEVEL OF EVIDENCE


Level II, Therapeutic Study.",2021,"DHS and PFN both increased hs-IL-6 (143.81 ± 89.12 and 94.13 ± 67.14, respectively), CRP (98.84 ± 31.81 and 104.4 ± 31.80, respectively), and CK (400.8 ± 31.81 and 250.7 ± 31.80, respectively) 24 hours postoperatively.","['patients with pertrochanteric fractures', 'A1-31.A2 pertrochanteric fractures were enrolled and allocated one of the two groups based on the treatment type: group DHS, (n =20,mean age = 78.4 ± 6.9 years) and group PFN (n = 20, mean age = 77.75 ± 7.0 years', '40 patients with AO-Müller/Orthopaedic Trauma Association (AO/OTA) 31']","['PFN', 'dynamic hip screw (DHS) or proximal femoral nail (PFN', 'proximal femoral nail versus dynamic hip screw']","['DHS and PFN both increased hs-IL-6', 'circulating levels of high sensitivity interleukin-6 (hs-IL-6), C-reactive protein (CRP), and creatine kinase (CK), and erythrocyte sedimentation rate', 'PFN', 'Operation time', 'operation time', ""CK levels' surgery time in DHS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281883', 'cui_str': 'Pertrochanteric fracture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0750863', 'cui_str': 'Finding of creatine kinase level'}]",40.0,0.0446886,"DHS and PFN both increased hs-IL-6 (143.81 ± 89.12 and 94.13 ± 67.14, respectively), CRP (98.84 ± 31.81 and 104.4 ± 31.80, respectively), and CK (400.8 ± 31.81 and 250.7 ± 31.80, respectively) 24 hours postoperatively.","[{'ForeName': 'Kushtrim', 'Initials': 'K', 'LastName': 'Grezda', 'Affiliation': 'Department of Orthopaedic Surgery, University Hospital Center Zagreb, School of Medicine, University of Zagreb, Zagreb, Croatia;Department of Orthopaedic and Traumatology, University Clinical Center of Kosovo, Prishtina, Kosovo;School of Medicine, University of Gjakova ""Fehmi Agani\'\', Gjakove, Kosovo.'}, {'ForeName': 'Mislav', 'Initials': 'M', 'LastName': 'Jelic', 'Affiliation': 'Department of Orthopaedic Surgery, University Hospital Center Zagreb, School of Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Armond', 'Initials': 'A', 'LastName': 'Daci', 'Affiliation': 'School of Medicine, University of Prishtina ""Hasan Prishtina"", Prishtina, Kosovo.'}, {'ForeName': 'Cen', 'Initials': 'C', 'LastName': 'Bytyqi', 'Affiliation': 'Department of Orthopaedic and Traumatology, University Clinical Center of Kosovo, Prishtina, Kosovo; School of Medicine, University of Prishtina ""Hasan Prishtina"", Prishtina, Kosovo.'}, {'ForeName': 'Qerim', 'Initials': 'Q', 'LastName': 'Kida', 'Affiliation': 'Department of Orthopaedic and Traumatology, University Clinical Center of Kosovo, Prishtina, Kosovo.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2021.20193']
174,34487151,"Pradefovir Treatment in Patients With Chronic Hepatitis B: Week 24 Results From a Multicenter, Double-Blind, Randomized, Noninferiority, Phase 2 Trial.","BACKGROUND


Pradefovir is a liver-targeted prodrug of adefovir, a nucleoside/nucleotide analogue with antiviral activity against hepatitis B virus (HBV) DNA polymerase. This phase 2 study compared the efficacy and safety of oral pradefovir (30, 45, 60, or 75 mg) versus tenofovir disoproxil fumarate (TDF; 300 mg) and aimed to identify the most appropriate dose of pradefovir for the forthcoming phase 3 study.
METHODS


Treatment-naive and experienced (not on treatment >6 months) patients with chronic hepatitis B were eligible.
RESULTS


A total of 240 participants were randomized and treated in the study (48 per group). Approximately 80% were hepatitis B e antigen (HBeAg) positive, and 10% had liver cirrhosis. The reductions from baseline in HBV DNA levels achieved at week 24 were 5.40, 5.34, 5.33, and 5.40 log10 IU/mL, with pradefovir doses of 30-, 45-, 60-, and 75-mg, respectively, compared with 5.12 log10 IU/mL with TDF. However, HBeAg loss was attained by more participants who received 45-, 60-, or 75-mg pradefovir than by those receiving TDF (12%, 6%, and 9% vs 3%). The TDF group exhibited a more significant increase in serum creatinine than the pradefovir 30- and 45-mg groups, and serum phosphate levels were comparable among all groups. Most adverse events (AEs) were mild (grade 1). No treatment-related severe AEs were reported. Overall, AEs and laboratory abnormalities were comparable to those in the TDF group.
CONCLUSIONS


Pradefovir and TDF exhibited comparable reductions in HBV DNA levels. All treatments were safe and well tolerated.
CLINICAL TRIALS REGISTRATION


NCT00230503 and China Drug Trials CTR2018042.",2022,"The TDF group exhibited a more significant increase in serum creatinine than the pradefovir 30mg or 45mg groups, and serum phosphate levels were comparable among all groups.","['Patients with Chronic Hepatitis B', '240 participants were randomized and treated in the study (48 per group', 'Treatment-naive and experienced (not on treatment >6 months) patients with chronic hepatitis B were eligible']","['oral pradefovir', 'Pradefovir Treatment', 'tenofovir disoproxil fumarate (TDF', 'TDF']","['HBV DNA levels', 'HBeAg loss', 'efficacy and safety', 'liver cirrhosis', 'serum creatinine', 'safe and well tolerated', 'severe adverse events', 'serum phosphate levels', 'Overall, adverse events and laboratory abnormalities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1692892', 'cui_str': 'pradefovir'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",240.0,0.100617,"The TDF group exhibited a more significant increase in serum creatinine than the pradefovir 30mg or 45mg groups, and serum phosphate levels were comparable among all groups.","[{'ForeName': 'Yanhang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Hepatology, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Department of Hepatology, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Infectious Diseases, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': ""Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Lvfeng', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of Infectious Diseases, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China.'}, {'ForeName': 'Yanzhong', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Infectious Diseases, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatology, The Second Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China.'}, {'ForeName': 'Huanyu', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Mu', 'Affiliation': 'Department of Infectious Diseases, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China.'}, {'ForeName': 'Hesong', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Department of Infectious Diseases, Yanbian University Affiliated Hospital, Yanji, Jilin, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Hepatology, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China.'}, {'ForeName': 'Xiaolu', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Diseases, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatology, The Second Hospital of Nanjing, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xuebing', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Infectious Disease, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Zhenjing', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Hepatology, The Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Shunde Hospital of Southern Medical University, Foshan, Guangdong, China.'}, {'ForeName': 'Qingjing', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Hepatology, Wuhan Hospital for Infectious Diseases, Wuhan, Hubei, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Caiyan', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Dengke', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Xintong Pharmaceutical Research, Xi'an, Shanxi, China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Jin', 'Affiliation': ""Xi'an Xintong Pharmaceutical Research, Xi'an, Shanxi, China.""}, {'ForeName': 'Daidi', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Xi'an Xintong Pharmaceutical Research, Xi'an, Shanxi, China.""}, {'ForeName': 'Xiuhong', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': ""Xi'an Xintong Pharmaceutical Research, Xi'an, Shanxi, China.""}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Xi'an Xintong Pharmaceutical Research, Xi'an, Shanxi, China.""}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': ""Institute of Infectious Diseases, First Affiliated Hospital of People's Liberation Army Medical University, Chongqing, China.""}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Phase I Clinical Trial, The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Quality Management, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Zong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatology, Jinan Hospital for Infectious Disease, Jinan, Shandong, China.'}, {'ForeName': 'Qianguo', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Department of Hepatology, Chinese Medicine Xiamen Hospital, Xiamen, Fujian, China.'}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Cirrhosis Department, Zhengzhou Sixth Municipal People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Department of Hepatology, The First Hospital of Jilin University, Changchun, Jilin, China.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab763']
175,33970363,Pilot study of an online training program to increase genetic literacy and communication skills in oncology healthcare professionals discussing BRCA1/2 genetic testing with breast and ovarian cancer patients.,"The increasing use of genetic testing for BRCA1/2 and other pathogenic variants in the management of women with breast and ovarian cancer necessitates increased genetic literacy in oncology healthcare professionals. This pilot study aimed to evaluate an online training program to increase genetic literacy and communication skills in Australian oncology healthcare professionals tasked with discussing and coordinating mainstream genetic testing with breast and ovarian cancer patients. A training website with embedded videos was developed. This study assesses the website's acceptability and user-friendliness; suggestions for improvement were also elicited. Oncology healthcare professionals were recruited through relevant professional organisations, invited to the study by email, asked to work through the website and then complete an online questionnaire. Thirty-two oncology healthcare professionals completed the questionnaire after viewing the website. Nearly all participants were satisfied with the information contained in the program (very satisfied: n = 14/32, 44%, satisfied: n = 17/32, 53%, neither satisfied nor dissatisfied: n = 1/32, 3%) and reported that they had gained new skills (n = 29/32, 91%) and had increased confidence (n = 29/31, 94%) in communicating with breast and ovarian cancer patients about genetic testing. More than 93% (28/30) of participants endorsed the online program as clearly presented, informative, relevant and useful. This pilot study demonstrated high feasibility and acceptability of the training program to increase genetic literacy and communication skills in oncology healthcare professionals discussing genetic testing with breast and ovarian cancer patients. Further evidence from a randomised trial is needed to evaluate effects on changing clinical practice, improving patient outcomes, and cost-effectiveness.",2022,This pilot study demonstrated high feasibility and acceptability of the training program to increase genetic literacy and communication skills in oncology healthcare professionals discussing genetic testing with breast and ovarian cancer patients.,"['Oncology healthcare professionals', 'Australian oncology healthcare professionals tasked with discussing and coordinating mainstream genetic testing with breast and ovarian cancer patients', 'women with breast and ovarian cancer', 'breast and ovarian cancer patients']","['online training program', 'training program']","['genetic literacy and communication skills', 'gained new skills']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0205314', 'cui_str': 'New'}]",,0.0349782,This pilot study demonstrated high feasibility and acceptability of the training program to increase genetic literacy and communication skills in oncology healthcare professionals discussing genetic testing with breast and ovarian cancer patients.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Meiser', 'Affiliation': 'Psychosocial Research Group, Prince of Wales Clinical School, University of New South Wales (UNSW), Level 4, C25 Lowy Building, Sydney, NSW, 2052, Australia. b.meiser@unsw.edu.au.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Woodward', 'Affiliation': 'The Med Collective Pty Ltd, Sydney, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gleeson', 'Affiliation': 'Hunter Family Cancer Service, Newcastle, Australia.'}, {'ForeName': 'Maira', 'Initials': 'M', 'LastName': 'Kentwell', 'Affiliation': 'Parkville Familial Cancer Clinic, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Helen Mar', 'Initials': 'HM', 'LastName': 'Fan', 'Affiliation': ""Genetic Health Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Yoland', 'Initials': 'Y', 'LastName': 'Antill', 'Affiliation': 'Parkville Familial Cancer Clinic, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Phyllis N', 'Initials': 'PN', 'LastName': 'Butow', 'Affiliation': 'Psycho-Oncology Co-Operative Research Group, Centre for Medical Psychology and Evidence-Based Decision-Making, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Boyle', 'Affiliation': 'School of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Best', 'Affiliation': 'Institute for Ethics and Society, University of Notre Dame, Sydney, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Taylor', 'Affiliation': 'Cancer Research Division, Cancer Council of New South Wales, Sydney, Australia.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Tucker', 'Affiliation': 'Hereditary Cancer Clinic, Prince of Wales Hospital and Prince of Wales Clinical School, UNSW Sydney, Sydney, Australia.'}]",Familial cancer,['10.1007/s10689-021-00261-1']
176,34459213,Effect of Empagliflozin on Worsening Heart Failure Events in Patients With Heart Failure and Preserved Ejection Fraction: EMPEROR-Preserved Trial.,"BACKGROUND


Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure with preserved ejection fraction, but additional data are needed about its effect on inpatient and outpatient heart failure events.
METHODS


We randomly assigned 5988 patients with class II through IV heart failure with an ejection fraction of >40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to usual therapy, for a median of 26 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite end points.
RESULTS


Empagliflozin reduced the combined risk of cardiovascular death, hospitalization for heart failure, or an emergency or urgent heart failure visit requiring intravenous treatment (432 versus 546 patients [empagliflozin versus placebo, respectively]; hazard ratio, 0.77 [95% CI, 0.67-0.87];  P <0.0001). This benefit reached statistical significance at 18 days after randomization. Empagliflozin reduced the total number of heart failure hospitalizations that required intensive care (hazard ratio, 0.71 [95% CI, 0.52-0.96];  P =0.028) and the total number of all hospitalizations that required a vasopressor or positive inotropic drug (hazard ratio, 0.73 [95% CI, 0.55-0.97];  P =0.033). Compared with patients in the placebo group, fewer patients in the empagliflozin group reported outpatient intensification of diuretics (482 versus 610; hazard ratio, 0.76 [95% CI, 0.67-0.86];  P <0.0001), and patients assigned to empagliflozin were 20% to 50% more likely to have a better New York Heart Association functional class, with significant effects at 12 weeks that were maintained for at least 2 years. The benefit on total heart failure hospitalizations was similar in patients with an ejection fraction of >40% to <50% and 50% to <60%, but was attenuated at higher ejection fractions.
CONCLUSIONS


In patients with heart failure with preserved ejection fraction, empagliflozin produced a meaningful, early, and sustained reduction in the risk and severity of a broad range of inpatient and outpatient worsening heart failure events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057977.",2021,"The benefit on total heart failure hospitalizations was similar in patients with an ejection fraction of >40-<50% and 50-<60%, but was attenuated at higher ejection fractions.  ","['Patients with Heart Failure and a Preserved Ejection Fraction', 'patients with heart failure and a preserved ejection fraction', '5988 patients with class II-IV heart failure with an ejection fraction of >40% to double-blind treatment with']","['placebo or empagliflozin', 'empagliflozin', 'empagliflozin vs placebo', 'placebo', 'Empagliflozin']","['outpatient intensification of diuretics', 'total heart failure hospitalizations', 'Worsening Heart Failure Events', 'total number of heart failure hospitalizations', 'total number of all hospitalizations', 'combined risk of cardiovascular death, hospitalization for heart failure or an emergent/urgent heart failure visit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}]",5988.0,0.483226,"The benefit on total heart failure hospitalizations was similar in patients with an ejection fraction of >40-<50% and 50-<60%, but was attenuated at higher ejection fractions.  ","[{'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.).'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France (F.Z., J.P.F.).'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Greece (G.F.).'}, {'ForeName': 'Joao Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France (F.Z., J.P.F.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (S.J.P.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Carson', 'Affiliation': 'Washington DC Veterans Affairs Medical Center (P.C.).'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis (I.A.).'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Doehner', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany (W.D., S.D.A.).'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Haass', 'Affiliation': 'Theresienkrankenhaus and St Hedwig-Klinik, Mannheim, Germany (M.H.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': 'Department of Cardiology, Hospital Saint Joseph, Paris, France (M.K.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'University of Florida, Jacksonville (A.M.).'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, University Hospital, Rigshospitalet, Copenhagen, Denmark (S.P.).'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California (J.R.T.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (S.S., C.Z.).'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (S.S., C.Z.).'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Schnee', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT (J.M.S.).'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany (W.D., S.D.A.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.056824']
177,34489211,"Midwife-led continuity of care improved maternal and neonatal health outcomes in north Shoa zone, Amhara regional state, Ethiopia: A quasi-experimental study.","BACKGROUND


In a low-resource setting, information on the effect of midwife-led continuity of care (MLCC) is limited. Therefore, this study aimed to determine the effect of MLCC on maternal and neonatal health outcomes in the Ethiopian context.
METHOD


A study with a quasi-experimental design was conducted from August 2019 to September 2020 in four primary hospitals of the north Shoa zone, Amhara regional state, Ethiopia. A total of 1178 low risk women were allocated to one of two groups; the midwife-led continuity of care (MLCC or intervention group) (received all antenatal, labour, birth, and immediate postnatal care from a single midwife or backup midwife) (n = 589) and the Shared model of care (SMC or comparison group) (received care from different staff members at different times) (n = 589). The two outcomes studied were Spontaneous vaginal birth and preterm birth. Outcome variables were compared using multivariate generalized linear models (GLMs) and reported using adjusted risk ratios (aRR) with 95% confidence intervals.
FINDINGS


Women in MLCC were, in comparison with women in the SMC group more likely to have spontaneous vaginal birth (aRR of 1.198 (95% CI 1.101-1.303)). Neonates of women in MLCC were in comparison with those in SMC less likely to be preterm (aRR of 0.394; 95% CI (0.227-0.683)).
CONCLUSION


In this study, use of the MLCC model improved maternal and neonatal health outcomes. To scale up and further investigate the effect and feasibility of this model in a low resource setting could be of considerable importance in Ethiopia and other Sub-Saharan Africa countries.",2022,"FINDINGS


Women in MLCC were, in comparison with women in the SMC group more likely to have spontaneous vaginal birth (aRR of 1.198 (95% CI 1.101-1.303)).","['1178 low risk women', 'August 2019 to September 2020 in four primary hospitals of the north Shoa zone, Amhara regional state, Ethiopia', 'north Shoa zone, Amhara regional state, Ethiopia']","['MLCC', 'midwife-led continuity of care (MLCC or intervention group) (received all antenatal, labour, birth, and immediate postnatal care from a single midwife or backup midwife) (n\u2009=\u2009589) and the Shared model of care (SMC or comparison group) (received care from different staff members']","['spontaneous vaginal birth', 'Spontaneous vaginal birth and preterm birth', 'adjusted risk ratios (aRR', 'maternal and neonatal health outcomes']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C1384485', 'cui_str': 'Delivery normal'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4042838', 'cui_str': 'Neonatal Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.117677,"FINDINGS


Women in MLCC were, in comparison with women in the SMC group more likely to have spontaneous vaginal birth (aRR of 1.198 (95% CI 1.101-1.303)).","[{'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Hailemeskel', 'Affiliation': 'School of Midwifery, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia; Department of Midwifery, College of Health Science, Debre Berhan University, Debre Berhan, Ethiopia. Electronic address: solomonhailemeskel9@gmail.com.'}, {'ForeName': 'Kassahun', 'Initials': 'K', 'LastName': 'Alemu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Kyllike', 'Initials': 'K', 'LastName': 'Christensson', 'Affiliation': ""Department of Women's and Children's Health, Division of Reproductive Health, Karolinska Institute, Sweden.""}, {'ForeName': 'Esubalew', 'Initials': 'E', 'LastName': 'Tesfahun', 'Affiliation': 'Department of Public Health, College of Health Science, Debre Berhan University, Debre Berhan, Ethiopia.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindgren', 'Affiliation': ""Department of Women's and Children's Health, Division of Reproductive Health, Karolinska Institute, Sweden.""}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2021.08.008']
178,34460904,Impact of Antibiotic Stewardship Rounds in the Intensive Care Setting: A Prospective Cluster-Randomized Crossover Study.,"BACKGROUND


Few groups have formally studied the effect of dedicated antibiotic stewardship rounds (ASRs) on antibiotic use (AU) in intensive care units (ICUs).
METHODS


We implemented weekly ASRs using a 2-arm, cluster-randomized, crossover study in 5 ICUs at Duke University Hospital from November 2017 to June 2018. We excluded patients without an active antibiotic order, or if they had a marker of high complexity including an existing infectious disease consult, transplantation, ventricular assist device, or extracorporeal membrane oxygenation. AU during and following ICU stay for patients with ASRs was compared to the controls. We recorded the number of reviews, recommendations delivered, and responses. We evaluated change in ICU-specific AU during and after the study.
RESULTS


Our analysis included 4683 patients: 2330 intervention and 2353 controls. Teams performed 761 reviews during ASRs, which excluded 1569 patients: 60% of patients off antibiotics, and 8% complex patients. Exclusions affected 88% of cardiothoracic ICU (CTICU) patients. The AU rate ratio (RR) was 0.97 (95% confidence interval [CI], .91-1.04). When CTICU was removed, the RR was 0.93 (95% CI, .89-.98). AU in the poststudy period decreased by 16% (95% CI, 11%-24%) compared to AU in the baseline period. Change in AU was differential among units: largest in the neurology ICU (-28%) and smallest in the CTICU (-2%).
CONCLUSIONS


Weekly multidisciplinary ASRs was a high-resource intervention associated with a small AU reduction. The noticeable ICU AU decline over time is possibly due to indirect effects of ASRs. Effects differed among specialty ICUs, emphasizing the importance of customizing ASRs to match unit-specific population, workflow, and culture.",2022,"Change in AU was differential among units: largest in the neurology ICU (-28%) and smallest in the CTICU (-2%).
","['5 ICUs at Duke University Hospital from 11/2017 to 6/2018', 'Exclusions affected 88% the cardiac surgery ICU (CTICU) patients', '4,683 patients: 2330 intervention and 2353 controls', 'patients without an active antibiotic order, or if they had a marker of high complexity including an existing infectious disease consult, transplant, ventricular assist device, or ECMO', 'Teams performed 761 reviews during ASRs, which excluded 1569 patients: 60% of patients off antibiotics, and 8% complex patients']",['Antibiotic Stewardship'],['AU rate ratio (RR'],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",4683.0,0.0211751,"Change in AU was differential among units: largest in the neurology ICU (-28%) and smallest in the CTICU (-2%).
","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Seidelman', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Turner', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Rebekah H', 'Initials': 'RH', 'LastName': 'Wrenn', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sarubbi', 'Affiliation': 'UNC Rex Healthcare, Raleigh, North Carolina, USA.'}, {'ForeName': 'Deverick J', 'Initials': 'DJ', 'LastName': 'Anderson', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Sexton', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Rebekah W', 'Initials': 'RW', 'LastName': 'Moehring', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab747']
179,34467969,"Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303).","BACKGROUND


Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC.
METHODS


Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS] = 0) at test-of-cure (day 11 ± 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS ≤ 1) at test-of-cure, and symptom resolution at follow-up (day 25 ± 4).
RESULTS


Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P = .001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P < .001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P < .001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P = .009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for Black patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity.
CONCLUSIONS


Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.",2022,"RESULTS


Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P=0.001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P<0.001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P<0.001) compared with placebo.","['vulvovaginal candidiasis (VVC', 'Patients', 'patients with acute VVC']","['placebo', 'ibrexafungerp', 'Ibrexafungerp versus placebo']","['rates of clinical cure', 'percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS≤1) at test-of-cure, and symptom resolution', 'efficacy and safety', 'Symptom resolution', 'mycological eradication', 'percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS]=0', 'tolerated', 'rates of clinical cure and clinical improvement at test-of-cure', 'overall success']","[{'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0852329', 'cui_str': 'Vulvovaginal signs and symptoms'}]",,0.569609,"RESULTS


Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P=0.001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P<0.001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P<0.001) compared with placebo.","[{'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Schwebke', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Sobel', 'Affiliation': 'Jefferson Vulvovaginal Health Center, Department of Obstetrics and Gynecology Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Gersten', 'Affiliation': 'New Age Medical Research Corp, Miami, Florida, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Sussman', 'Affiliation': 'Lawrence OB/GYN Clinical Research, Lawrenceville, New Jersey, USA.'}, {'ForeName': 'Samuel N', 'Initials': 'SN', 'LastName': 'Lederman', 'Affiliation': 'Altus Research Inc, Lake Worth, Florida, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Jacobs', 'Affiliation': 'Life Research, Inc, Houston, Texas, USA.'}, {'ForeName': 'B Todd', 'Initials': 'BT', 'LastName': 'Chappell', 'Affiliation': 'WR-Medical Research Center of Memphis, LLC, Memphis, Tennessee, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Weinstein', 'Affiliation': ""Consultants in Women's Healthcare, Inc, St. Louis, Missouri, USA.""}, {'ForeName': 'Alfred H', 'Initials': 'AH', 'LastName': 'Moffett', 'Affiliation': 'OB-GYN Associates of Mid-Florida, PA, Leesburg, Florida, USA.'}, {'ForeName': 'Nkechi E', 'Initials': 'NE', 'LastName': 'Azie', 'Affiliation': 'SCYNEXIS, Inc, Jersey City, New Jersey, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Angulo', 'Affiliation': 'SCYNEXIS, Inc, Jersey City, New Jersey, USA.'}, {'ForeName': 'Itzel A', 'Initials': 'IA', 'LastName': 'Harriott', 'Affiliation': 'SCYNEXIS, Inc, Jersey City, New Jersey, USA.'}, {'ForeName': 'Katyna', 'Initials': 'K', 'LastName': 'Borroto-Esoda', 'Affiliation': 'KBE Consulting, Raleigh, North Carolina, USA.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Ghannoum', 'Affiliation': 'Case Western Reserve University and University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nyirjesy', 'Affiliation': 'Jefferson Vulvovaginal Health Center, Department of Obstetrics and Gynecology Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Sobel', 'Affiliation': 'Wayne State University, Detroit, Michigan, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab750']
180,34030555,"Efficacy and safety of inhaled extrafine beclomethasone dipropionate in adults with asthma: a randomized, parallel-group, dose-ranging study (BEAM).","Introduction:  This manuscript describes a Phase II, dose-ranging, randomized, double-blind, placebo- and active-controlled, parallel-group study conducted to identify the appropriate dose of beclomethasone dipropionate (BDP) to be used in a single-inhaler extrafine formulation triple combination of BDP, formoterol fumarate and glycopyrronium. Methods:  Patients aged 18-75 years with poorly-controlled asthma, receiving low/medium-dose inhaled corticosteroid (ICS), and who had forced expiratory volume in the 1st second (FEV 1 ) 50-85% predicted, were randomized to inhale BDP 50, 200 or 400 µg twice daily (BID; total daily doses of 100, 400 and 800 µg), placebo, or the active comparator QVAR® 160 µg BID, all via pressurized metered-dose inhalers for 8 weeks. The primary objective was to evaluate superiority of BDP over placebo for change from baseline in pre-dose morning FEV 1  at Week 8. ClinicalTrials.gov: NCT03084718. Results:  Of 610 patients randomized, 559 (91.6%) completed the study. For pre-dose morning FEV 1  at Week 8, BDP 200 µg BID was superior to placebo, with a statistically significant difference of 113 ml (95% CI 18, 209); differences vs placebo for BDP 50 and 400 µg BID were not significant (44 [-52, 140] and 93 [-3, 188] ml, respectively). Secondary efficacy endpoint results supported the primary endpoint in identifying BDP 200 µg BID as the appropriate dose. Adverse events were experienced by 23.5, 25.0 and 30.6% patients with BDP 50, 200 and 400 µg BID, 34.7% with placebo, and 30.6% with the active comparator. Conclusion:  In this dose-ranging study, BDP 200 µg BID offered the optimal balance of efficacy and safety in patients with asthma poorly controlled on low/medium-dose ICS.Supplemental data for this article is available online at at www.tandfonline.com/ijas .",2022,"For pre-dose morning FEV 1  at Week 8, BDP 200 µg BID was superior to placebo, with a statistically significant difference of 113 ml (95% CI 18, 209); differences vs placebo for BDP 50 and 400 µg BID were not significant (44 [-52, 140] and 93 [-3, 188] ml, respectively).","['610 patients randomized, 559 (91.6%) completed the study', 'Patients aged 18-75\u2009years with poorly-controlled asthma, receiving low/medium-dose inhaled corticosteroid (ICS), and who had forced expiratory volume in the 1st second (FEV 1 ) 50-85% predicted', 'patients with asthma', 'adults with asthma']","['BDP, formoterol fumarate and glycopyrronium', 'placebo, or the active comparator QVAR® 160\u2009µg BID', 'beclomethasone dipropionate (BDP', 'inhaled extrafine beclomethasone dipropionate', 'placebo']","['superiority of BDP', 'efficacy and safety', 'Efficacy and safety', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0731268', 'cui_str': 'Aerobec'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0004906', 'cui_str': 'Beclomethasone dipropionate'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",610.0,0.66881,"For pre-dose morning FEV 1  at Week 8, BDP 200 µg BID was superior to placebo, with a statistically significant difference of 113 ml (95% CI 18, 209); differences vs placebo for BDP 50 and 400 µg BID were not significant (44 [-52, 140] and 93 [-3, 188] ml, respectively).","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Montanaro', 'Affiliation': 'Northwest Research Center, Portland, OR, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Weinstein', 'Affiliation': 'Allergy and Asthma Specialists Medical Group, Huntington Beach, CA, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Beaudot', 'Affiliation': 'Global\xa0Clinical Development, Chiesi USA, Inc, Cary, NC, USA.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Scott', 'Affiliation': 'Global\xa0Clinical Development, Chiesi USA, Inc, Cary, NC, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Georges', 'Affiliation': 'Global\xa0Clinical Development, Chiesi USA, Inc, Cary, NC, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2021.1928184']
181,34060988,RNA Sequencing Reveals the Wound Repair Mechanism of Cuyuxunxi Prescription in Surgical Patients with Anal Fistulas.,"BACKGROUND


Anal fistula is one of the most common colorectal and perirectal diseases in the world. Cuyuxunxi (CYXX) prescription is an efficient herbal fumigant used to promote the surgical wound healing of anal fistulas.
OBJECTIVES


This study aimed to explore the underlying molecular mechanism of CYXX prescription on surgical wound healing of anal fistulas.
METHODS


Ten patients with anal fistula were randomized into a control group or treatment group. The wound surface of patients in the control group was rinsed by normal saline, while that in the treatment group was rinsed by CYXX prescription. The wound tissues of patients with anal fistulas seven days after the surgery were collected for hematoxylin-eosin (HE) staining and RNA sequencing. The expressions of differentially expressed genes (DEGs) were validated by real-time quantitative PCR (RT-qPCR).
RESULTS


HE staining showed that CYXX treatment reduced the infiltration of inflammatory cells. A total of 472 DEGs, including 141 up-regulated genes and 331 down-regulated genes, were identified. These genes were significantly related to skin development, xenobiotic stimulus, and inflammation. In addition, the consistency rate of RT-qPCR and sequencing results was 83.33%, which showed a high relative reliability of the sequencing results.
CONCLUSION


CYXX prescription could improve epidermis repair and reduce inflammatory responses.",2022,"The expressions of differentially expressed genes (DEGs) were validated by real-time quantitative PCR (RT-qPCR).
","['Ten patients with anal fistula', 'Surgical Patients with Anal Fistulas', 'A total of 472 DEGs, including 141 up-regulated genes and 331 down-regulated genes, were identified']","['CYXX prescription', 'Cuyuxunxi (CYXX) prescription', 'CYXX']","['epidermis repair and reduce inflammatory responses', 'skin development, xenobiotic stimulus, and inflammation', 'infiltration of inflammatory cells', 'consistency rate of RT-qPCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149889', 'cui_str': 'Anorectal fistula'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0043335', 'cui_str': 'Xenobiotics'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}]",10.0,0.0394306,"The expressions of differentially expressed genes (DEGs) were validated by real-time quantitative PCR (RT-qPCR).
","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': 'Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201210, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201210, China.'}, {'ForeName': 'Yafeng', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201210, China.'}, {'ForeName': 'De', 'Initials': '', 'LastName': 'Zheng', 'Affiliation': 'Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201210, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201210, China.'}]",Combinatorial chemistry & high throughput screening,['10.2174/1386207324666210520112816']
182,34459659,"Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial.","BACKGROUND


Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device.
METHODS


Patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points.
RESULTS


A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=-0.14 [95% CI, -3.42 to 3.13];  P <0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% versus 10.0% and 3.9% versus 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% versus 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness end point (2.8% versus 2.8%; difference=0.00 [95% CI, -1.55 to 1.55];  P <0.001 for noninferiority), and the composite of stroke, systemic embolism, or cardiovascular/unexplained death (5.6% versus 7.7%, difference=-2.12 [95% CI, -4.45 to 0.21];  P <0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% versus 12.3%; difference=-0.71 [95% CI, -3.72 to 2.31];  P =0.32 for superiority). LAA occlusion was higher for the Amulet occluder than for the Watchman device (98.9% versus 96.8%; difference=2.03 [95% CI, 0.41-3.66];  P <0.001 for noninferiority;  P =0.003 for superiority).
CONCLUSIONS


The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02879448.",2021,"The Amulet occluder was non-inferior for safety and effectiveness of stroke prevention for NVAF compared with the Watchman device, and superior for LAA occlusion.","['patients with non-valvular atrial fibrillation (NVAF', 'Patients with NVAF at increased risk of stroke', '1878 patients were enrolled']","['URL', ':  Percutaneous closure of the left atrial appendage (LAA', 'percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device']","['safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months) and effectiveness (composite of ischemic stroke or systemic embolism at 18 months) and the rate of LAA occlusion', 'LAA occlusion', 'safety and effectiveness', 'Procedure-related complications', 'Major bleeding and all-cause death', 'rate of major bleeding', 'composite of stroke, systemic embolism or cardiovascular/unexplained death', 'composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0277589', 'cui_str': 'Death of unknown cause'}]",1878.0,0.351319,"The Amulet occluder was non-inferior for safety and effectiveness of stroke prevention for NVAF compared with the Watchman device, and superior for LAA occlusion.","[{'ForeName': 'Dhanunjaya', 'Initials': 'D', 'LastName': 'Lakkireddy', 'Affiliation': 'Kansas City Heart Rhythm Institute and Research Foundation, Overland Park (D.L.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thaler', 'Affiliation': 'Tufts Medical Center, Boston, MA (D.T.).'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Ellis', 'Affiliation': 'Vanderbilt Heart Institute, Nashville, TN (C.R.E).'}, {'ForeName': 'Vijendra', 'Initials': 'V', 'LastName': 'Swarup', 'Affiliation': 'Arizona Cardiovascular Research Center, Phoenix (V.S.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Sondergaard', 'Affiliation': 'Righospitalet, Copenhagen, Denmark (L.S.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'University of Colorado Hospital, Anschultz Medical Campus, Aurora (J.C.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Medical University of South Carolina, Charleston (M.R.G.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hermiller', 'Affiliation': 'St. Vincent Medical Group Inc, Indianapolis, IN (J.H.).'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'University Duisburg-Essen, Germany (H.-C.D.).'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Schmidt', 'Affiliation': 'Cardioangiologisches Centrum Bethanien, Frankfurt, Germany (B.S.).'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'MacDonald', 'Affiliation': 'South Denver Cardiology Associates P.C., Littleton, CO (L.M.).'}, {'ForeName': 'Moussa', 'Initials': 'M', 'LastName': 'Mansour', 'Affiliation': 'Massachusetts General Hospital, Boston (M.M.).'}, {'ForeName': 'Brijeshwar', 'Initials': 'B', 'LastName': 'Maini', 'Affiliation': 'Delray Medical Center, FL (B.M.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""O'Brien"", 'Affiliation': 'Abbott Structural Heart, Plymouth, MN (L.O.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Inselspital, University of Bern, Switzerland (S.W.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057063']
183,34023318,"Personalized Variable vs Fixed-Dose Systemic Corticosteroid Therapy in Hospitalized Patients With Acute Exacerbations of COPD: A Prospective, Multicenter, Randomized, Open-Label Clinical Trial.","BACKGROUND


Systemic corticosteroids for the treatment of COPD exacerbations decrease treatment failure and shorten the length of hospitalization. However, the optimal dose is unclear.
RESEARCH QUESTION


Is personalized-dose corticosteroid administered according to a dosing scale more effective than fixed-dose corticosteroid administration in hospitalized patients with COPD with exacerbations?
STUDY DESIGN AND METHODS


This was a prospective, randomized, open-label trial. In-hospital patients with COPD with exacerbations were randomly assigned at a 1:1 ratio to either the fixed-dose group (receiving the equivalent of 40 mg of prednisolone) or the personalized-dose group for 5 days. The primary end point was a composite measure of treatment failure that included in-hospital treatment failure and medium-term (postdischarge) failure. Secondary end points were length of stay and cost.
RESULTS


A total of 248 patients were randomly assigned to the fixed-dose group (n = 124) or personalized-dose group (n = 124). One patient in each group was not included in the intention-to-treat population because of incorrect initial COPD diagnosis. Failure of therapy occurred in 27.6% in the personalized-dose group, compared with 48.8% in the fixed-dose group (relative risk, 0.40; 95% CI, 0.24-0.68; P = .001). The in-hospital failure of therapy was significantly lower in the personalized-dose group (10.6% vs 24.4%; P = .005), whereas the medium-term failure rate, adverse event rate, hospital length of stay, and costs were similar between the two groups. After treatment failure, a lower additional dose of corticosteroids and a shorter duration of treatment were needed in the personalized-dose group to achieve control of the exacerbation. In the personalized-dose cohort, those receiving 40 mg or less had an average failure rate of 44.4%, compared with 22.9% among those receiving more than 40 mg (P = .027).
INTERPRETATION


Personalized dosing of corticosteroids reduces the risk of failure because more patients were provided with a higher initial dose, especially > 60 mg, whereas 40 mg or less was too low in either group.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT02147015; URL: www.clinicaltrials.gov.",2021,"Failure of therapy occurred in 27.6% in the personalised-dose group, compared to 48.8% in the fixed-dose group (RR 0.40, 95% CI 0.24-0.68, p = 0.001).","['248 patients', 'hospitalized COPD patients with exacerbations', 'In-hospital COPD patients with exacerbations', 'Hospitalized Patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease']","['Personalised Variable vs Fixed Dose Systemic Corticosteroid Therapy', 'prednisolone equivalent) or personalised-dose group for 5 days', 'corticosteroids']","['composite measure of treatment failure that included in-hospital treatment failure and medium-term (post-discharge) failure', 'length of stay and cost', 'average failure rate', 'Failure of therapy', 'medium-term failure rate, adverse event rate, hospital length of stay and costs', 'hospital failure of therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",248.0,0.157885,"Failure of therapy occurred in 27.6% in the personalised-dose group, compared to 48.8% in the fixed-dose group (RR 0.40, 95% CI 0.24-0.68, p = 0.001).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, College of Preventive Medicine, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Fenfen', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Binfeng', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Institute of Respiratory Diseases, Xinqiao Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': ""Chongqing Ninth People's Hospital, Chongqing, China.""}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China; Department of Respiratory Medicine, Third Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xingsheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Chongqing Emergency Medical Center, Central Hospital Affiliated to Chongqing University, Chongqing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Shisi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Naifu', 'Initials': 'N', 'LastName': 'Nie', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jones', 'Affiliation': ""Institute for Infection and Immunity, St. George's, University of London, London, United Kingdom.""}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Third Military Medical University (Army Medical University), Chongqing, China. Electronic address: cgq1963@163.com.'}]",Chest,['10.1016/j.chest.2021.05.024']
184,34044738,"Breathing exercises in older adults with asthma: a blinded, randomized, placebo-controlled trial.","OBJECTIVE


Breathing exercises have been found to benefit patients with some respiratory disorders, but can take a significant amount of time to complete. The effects of a breathing exercise program are unknown. The aim of this study was to evaluate the effectiveness of a short multi-component exercise program for older adults with asthma.
METHODS


To be included, subjects were age 65 years or older with persistent asthma. 90 subjects with predominantly moderate to severe asthma were randomized, 45 each, into either the exercise or control groups. After in person training at the initial visit, those in the exercise group performed a short three-part exercise program twice per day at home for one month. Those in the control group performed 2 breaths with the incentive spirometer twice per day. At the initial visit patients completed baseline questionnaires assessing demographic information, asthma control (Asthma Control Test - ACT) and quality of life (mini-Asthma Quality of Life Questionnaire - mini-AQLQ) as well as spirometry. After the one-month period at the follow-up visit the ACT, mini-AQLQ, and spirometry were repeated.
RESULTS


Subjects in the intervention felt that breathing exercises were helpful, and 87% would recommend them to a friend. Although both groups had improvement in ACT and mini-AQLQ, there were no differences between groups. FEV1 was lower in both groups.
CONCLUSION


Although a short breathing exercise program was acceptable for older adults with asthma, it did not produce meaningful improvements in asthma outcomes. A longer program may be necessary.",2022,"Although a short breathing exercise program was acceptable for older adults with asthma, it did not produce meaningful improvements in asthma outcomes.","['To be included, subjects were age 65\u2009years or older with persistent asthma', 'older adults with asthma', 'older adults', '90 subjects with predominantly moderate to severe asthma']","['short breathing exercise program', 'Breathing exercises', 'short multi-component exercise program', 'breathing exercise program']","['baseline questionnaires assessing demographic information, asthma control (Asthma Control Test - ACT) and quality of life (mini-Asthma Quality of Life Questionnaire - mini-AQLQ', 'FEV1', 'ACT and mini-AQLQ']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2919855', 'cui_str': 'Mini asthma quality of life questionnaire'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",90.0,0.0196745,"Although a short breathing exercise program was acceptable for older adults with asthma, it did not produce meaningful improvements in asthma outcomes.","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Coulson', 'Affiliation': 'Allergy Partners of Western North Carolina, Asheville, NC, USA.'}, {'ForeName': 'Laurie M', 'Initials': 'LM', 'LastName': 'Carpenter', 'Affiliation': 'Department of Medicine, Division of Allergy and Clinical Immunology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Todd E', 'Initials': 'TE', 'LastName': 'Georgia', 'Affiliation': 'Department of Medicine, Division of Allergy and Clinical Immunology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Baptist', 'Affiliation': 'Department of Medicine, Division of Allergy and Clinical Immunology, University of Michigan, Ann Arbor, MI, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2021.1936015']
185,34033117,Relapse following bitemporal and high-dose right unilateral electroconvulsive therapy for major depression.,"OBJECTIVE


Electroconvulsive therapy (ECT) is an effective acute treatment for severe and/or medication-resistant depression but maintaining remission following completion of a course remains a clinical challenge.
METHODS


EFFECT-Dep Trial (ISRCTN23577151) participants with a DSM-IV major depressive episode who met remission criteria after a randomly assigned course of twice-weekly brief-pulse bitemporal (1.5 × seizure threshold) or high-dose (6 × seizure threshold) right unilateral ECT were monitored for relapse for 12 months. In line with the pragmatic trial design, all patients received treatment-as-usual individualised pharmacotherapy during and after ECT; no remitter received continuation ECT.
RESULTS


Of 61 remitters, 24 (39.3%) relapsed, one (1.6%) withdrew from the study while in remission and the remaining 36 (59.0%) stayed well for a year. Most relapses occurred within the first six months, resulting in a cumulative six-month relapse rate of 31.1%. In a multivariable Cox proportional hazards regression model, older age (p = 0.039) and psychotic features at pre-ECT baseline (p = 0.037) were associated with a more favourable long-term prognosis while a greater number of previous depressive episodes (p = 0.028) and bipolar II (but not bipolar I) diagnosis (p = 0.030) were associated with a worse long-term outcome. Electrode placement and medication resistance prior to ECT had no effect on relapse. Adjusting for covariates, fewer patients treated with lithium relapsed in the overall group (p = 0.008) and in the unipolar depression subgroup (p = 0.027).
CONCLUSION


Long-term outcome following high-dose right unilateral ECT does not differ from bitemporal ECT. Prognosis is particularly favourable in older adults, psychotic depression and patients maintained on lithium.",2021,"Adjusting for covariates, fewer patients treated with lithium relapsed in the overall group (p=0.008) and in the unipolar depression subgroup (p=0.027).
","['ISRCTN23577151) participants with a DSM-IV major depressive episode who met remission criteria after a randomly assigned course of', 'older adults, psychotic depression and patients maintained on lithium']","['Electroconvulsive therapy (ECT', 'twice-weekly brief-pulse bitemporal (1.5 x seizure threshold) or high-dose (6 x seizure threshold) right unilateral ECT', 'bitemporal and high-dose right unilateral electroconvulsive therapy', 'continuation ECT', 'ECT']","['relapse', 'previous depressive episodes', 'cumulative six-month relapse rate']","[{'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0240220', 'cui_str': 'On lithium'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0444804', 'cui_str': 'Brief pulse'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]",,0.122763,"Adjusting for covariates, fewer patients treated with lithium relapsed in the overall group (p=0.008) and in the unipolar depression subgroup (p=0.027).
","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Jelovac', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kolshus', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Declan M', 'Initials': 'DM', 'LastName': 'McLoughlin', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin 8, Ireland.""}]",Acta psychiatrica Scandinavica,['10.1111/acps.13331']
186,34472021,An Intensive Intervention to Reduce Readmissions for Frequently Hospitalized Patients: the CHAMP Randomized Controlled Trial.,"BACKGROUND


A small number of patients are disproportionally readmitted to hospitals. The Complex High Admission Management Program (CHAMP) was established as a multidisciplinary program to improve continuity of care and reduce readmissions for frequently hospitalized patients.
OBJECTIVE


To compare hospital utilization metrics among patients enrolled in CHAMP and usual care.
DESIGN


Pragmatic randomized controlled trial.
PARTICIPANTS


Inclusion criteria were as follows: 3 or more, 30-day inpatient readmissions in the previous year; or 2 inpatient readmissions plus either a referral or 3 observation admissions in previous 6 months.
INTERVENTIONS


Patients randomized to CHAMP were managed by an interdisciplinary team including social work, physicians, and pharmacists. The CHAMP team used comprehensive care planning and inpatient, outpatient, and community visits to address both medical and social needs. Control patients were randomized to usual care and contacted 18 months after initial identification if still eligible.
MAIN MEASURES


Primary outcome was number of 30-day inpatient readmissions 180 days following enrollment. Secondary outcomes were number of hospital admissions, total hospital days, emergency department visits, and outpatient clinic visits 180 days after enrollment.
KEY RESULTS


There were 75 patients enrolled in CHAMP, 76 in control. Groups were similar in demographic characteristics and baseline readmissions. At 180 days following enrollment, CHAMP patients had more inpatient 30-day readmissions [CHAMP incidence rate 1.3 (95% CI 0.9-1.8) vs. control 0.8 (95% CI 0.5-1.1), p=0.04], though both groups had fewer readmissions compared to 180 days prior to enrollment. We found no differences in secondary outcomes.
CONCLUSIONS


Frequently hospitalized patients experienced reductions in utilization over time. Though most outcomes showed no difference, CHAMP was associated with higher readmissions compared to a control group, possibly due to consolidation of care at a single hospital. Future research should seek to identify subsets of patients with persistently high utilization for whom tailored interventions may be beneficial.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03097640; https://clinicaltrials.gov/ct2/show/NCT03097640.",2022,"At 180 days following enrollment, CHAMP patients had more inpatient 30-day readmissions [CHAMP incidence rate 1.3 (95% CI 0.9-1.8) vs. control 0.8 (95% CI 0.5-1.1), p=0.04], though both groups had fewer readmissions compared to 180 days prior to enrollment.","['Inclusion criteria were as follows: 3 or more, 30-day inpatient readmissions in the previous year; or 2 inpatient readmissions plus either a referral or 3 observation admissions in previous 6 months', 'patients enrolled in CHAMP and usual care', '75 patients enrolled in CHAMP, 76 in control', 'Frequently Hospitalized Patients']","['CHAMP', 'Intensive Intervention']","['inpatient 30-day readmissions [CHAMP incidence rate', 'hospital utilization metrics', 'number of 30-day inpatient readmissions 180 days following enrollment', 'number of hospital admissions, total hospital days, emergency department visits, and outpatient clinic visits 180 days after enrollment']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",75.0,0.1787,"At 180 days following enrollment, CHAMP patients had more inpatient 30-day readmissions [CHAMP incidence rate 1.3 (95% CI 0.9-1.8) vs. control 0.8 (95% CI 0.5-1.1), p=0.04], though both groups had fewer readmissions compared to 180 days prior to enrollment.","[{'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Henschen', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. b-henschen@northwestern.edu.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Theodorou', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Chapman', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'McKay', 'Initials': 'M', 'LastName': 'Barra', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Toms', 'Affiliation': 'Department of Social Work, Northwestern Memorial Hospital, Chicago, IL, USA.'}, {'ForeName': 'Kenzie A', 'Initials': 'KA', 'LastName': 'Cameron', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Shuhan', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yeh', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jungwha', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': ""O'Leary"", 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-021-07048-1']
187,34469334,Effective Dose of Prophylactic Oxytocin Infusion During Cesarean Delivery in 90% Population of Nonlaboring Patients With Preeclampsia Receiving Magnesium Sulfate Therapy and Normotensives: An Up-Down Sequential Allocation Dose-Response Study.,"BACKGROUND


Oxytocin administration during cesarean delivery is the first-line therapy for the prevention of uterine atony. Patients with preeclampsia may receive magnesium sulfate, a drug with known tocolytic effects, for seizure prophylaxis. However, no study has evaluated the minimum effective dose of oxytocin during cesarean delivery in women with preeclampsia.
METHODS


This study compared the effective dose in 90% population (ED90) of oxytocin infusion for achieving satisfactory uterine tone during cesarean delivery in nonlaboring patients with preeclampsia who were receiving magnesium sulfate treatment with a control group of normotensives who were not receiving magnesium sulfate. This prospective dual-arm dose-finding study was based on a 9:1 biased sequential allocation design. Oxytocin infusion was initiated at 13 IU/h, on clamping of the umbilical cord, in the first patient of each group. Uterine tone was graded as satisfactory or unsatisfactory by the obstetrician at 4 minutes after initiation of oxytocin infusion. The dose of oxytocin infusion for subsequent patients was decided according to the response exhibited by the previous patient in the group; it was increased by 2 IU/h after unsatisfactory response or decreased by 2 IU/h or maintained at the same level after satisfactory response, in a ratio of 1:9. Oxytocin-associated side effects were also evaluated. Dose-response data for the groups were evaluated using a log-logistic function and ED90 estimates were derived from fitted equations using the delta method.
RESULTS


The ED90 of oxytocin was significantly greater for the preeclampsia group (n = 27) than for the normotensive group (n = 40) (24.9 IU/h [95% confidence interval {CI}, 22.4-27.5] and 13.9 IU/h [95% CI, 12.4-15.5], respectively); the difference in dose requirement was 10.9 IU/h (95% CI, 7.9-14.0; P < .001). The number of patients with oxytocin-related hypotension, defined as a decrease in systolic blood pressure >20% from baseline or to <90 mm Hg, was significantly greater in the preeclampsia group (92.6% vs 62.5%; P = .030), while other side effects such as ST-T depression, nausea/vomiting, headache, and flushing, were not significantly different. There was no significant difference in the need for additional uterotonic or uterine massage, estimated blood loss, and need for re-exploration for uncontrolled bleeding.
CONCLUSIONS


Patients with preeclampsia receiving preoperative magnesium therapy need a greater intraoperative dose of oxytocin to achieve satisfactory contraction of the uterus after fetal delivery, as compared to normotensives.",2022,"There was no significant difference in the need for additional uterotonic or uterine massage, estimated blood loss, and need for re-exploration for uncontrolled bleeding.
","['Patients with preeclampsia', 'treatment with a control group of normotensives who were not receiving', 'nonlaboring patients with preeclampsia who were receiving', 'women with preeclampsia', 'Patients with preeclampsia receiving preoperative', '90% Population of Nonlaboring Patients']","['magnesium therapy', 'Prophylactic Oxytocin Infusion', 'magnesium sulfate', 'oxytocin infusion', 'Oxytocin', 'Magnesium Sulfate Therapy and Normotensives', 'oxytocin']","['side effects such as ST-T depression, nausea/vomiting, headache, and flushing', 'ED90 of oxytocin', 'systolic blood pressure', 'additional uterotonic or uterine massage, estimated blood loss, and need for re-exploration for uncontrolled bleeding', 'Oxytocin-associated side effects', 'Uterine tone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}, {'cui': 'C0404386', 'cui_str': 'Uterine massage'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1293095', 'cui_str': 'Reexploration procedure'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}]",,0.085272,"There was no significant difference in the need for additional uterotonic or uterine massage, estimated blood loss, and need for re-exploration for uncontrolled bleeding.
","[{'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Tyagi', 'Affiliation': 'From the Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'From the Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Yuvraj', 'Initials': 'Y', 'LastName': 'Singh', 'Affiliation': 'From the Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Luthra', 'Affiliation': 'From the Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Devansh', 'Initials': 'D', 'LastName': 'Garg', 'Affiliation': 'From the Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Rajeev Kumar', 'Initials': 'RK', 'LastName': 'Malhotra', 'Affiliation': 'Delhi Cancer Registry, Dr BR Ambedkar Institute-Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005701']
188,34508740,Global Research Expedition on Altitude-related Chronic Health 2018 Iron Infusion at High Altitude Reduces Hypoxic Pulmonary Vasoconstriction Equally in Both Lowlanders and Healthy Andean Highlanders.,"BACKGROUND


Increasing iron bioavailability attenuates hypoxic pulmonary vasoconstriction in both lowlanders and Sherpas at high altitude. In contrast, the pulmonary vasculature of Andean individuals with chronic mountain sickness (CMS) is resistant to iron administration. Although pulmonary vascular remodeling and hypertension are characteristic features of CMS, the effect of iron administration in healthy Andean individuals, to our knowledge, has not been investigated. If the interplay between iron status and pulmonary vascular tone in healthy Andean individuals remains intact, this could provide valuable clinical insight into the role of iron regulation at high altitude.
RESEARCH QUESTION


Is the pulmonary vasculature in healthy Andean individuals responsive to iron infusion?
STUDY DESIGN AND METHODS


In a double-blinded, block-randomized design, 24 healthy high-altitude Andean individuals and 22 partially acclimatized lowlanders at 4,300 m (Cerro de Pasco, Peru) received an IV infusion of either 200 mg of iron (III)-hydroxide sucrose or saline. Markers of iron status were collected at baseline and 4 h after infusion. Echocardiography was performed in participants during room air breathing (partial pressure of inspired oxygen [Pio 2 ] of approximately 96 mm Hg) and during exaggerated hypoxia (Pio 2  of approximately 73 mm Hg) at baseline and at 2 and 4 h after the infusion.
RESULTS


Iron infusion reduced pulmonary artery systolic pressure (PASP) by approximately 2.5 mm Hg in room air (main effect, P < .001) and by approximately 7 mm Hg during exaggerated hypoxia (main effect, P < .001) in both lowlanders and healthy Andean highlanders. There was no change in PASP after the infusion of saline. Iron metrics were comparable between groups, except for serum ferritin, which was 1.8-fold higher at baseline in the Andean individuals than in the lowlanders (95% CI, 74-121 ng/mL vs 37-70 ng/mL, respectively; P = .003).
INTERPRETATION


The pulmonary vasculature of healthy Andean individuals and lowlanders remains sensitive to iron infusion, and this response seems to differ from the pathologic characteristics of CMS.",2022,"Iron metrics were comparable between groups, except for serum ferritin, which was 1.8-fold higher at baseline in the Andeans when compared to lowlanders [95% confidence interval (CI) 74-121 ng/ml vs. 37-70 ng/ml, respectively; P=0.003].
","['healthy Andeans', 'lowlanders and healthy Andean highlanders', 'Andeans suffering with chronic mountain sickness', '24 healthy high-altitude Andeans and 22 partially acclimatized lowlanders at 4300 m (Cerro de Pasco, Peru), received an i.v']","['Echocardiography was performed during room-air breathing (P', 'iron [iron (III)-hydroxide sucrose; 200mg] or saline']","['pulmonary artery systolic pressure (PASP', 'PASP', 'Markers of iron status', 'serum ferritin', 'hypoxic pulmonary vasoconstriction']","[{'cui': 'C0274294', 'cui_str': 'Chronic mountain sickness'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0060236', 'cui_str': 'ferric hydroxide'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}]",24.0,0.0691186,"Iron metrics were comparable between groups, except for serum ferritin, which was 1.8-fold higher at baseline in the Andeans when compared to lowlanders [95% confidence interval (CI) 74-121 ng/ml vs. 37-70 ng/ml, respectively; P=0.003].
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Patrician', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC. Electronic address: alexander.patrician@alumni.ubc.ca.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Dawkins', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff.'}, {'ForeName': 'Geoff B', 'Initials': 'GB', 'LastName': 'Coombs', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stacey', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, Glamorgan, Wales.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gasho', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, Loma Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Gibbons', 'Affiliation': 'School of Physical Education, Sport and Exercise Science, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Connor A', 'Initials': 'CA', 'LastName': 'Howe', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Tremblay', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Stone', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Tymko', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Tymko', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Akins', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, Loma Linda University School of Medicine, Loma Linda, CA; Department of Kinesiology, University of Texas, Arlington, TX.'}, {'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Hoiland', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Vizcardo-Galindo', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC; Laboratorio de Fisiología Comparada/Fisiología del Transporte de Oxígeno, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Rómulo', 'Initials': 'R', 'LastName': 'Figueroa-Mujíca', 'Affiliation': 'Laboratorio de Fisiología Comparada/Fisiología del Transporte de Oxígeno, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Francisco C', 'Initials': 'FC', 'LastName': 'Villafuerte', 'Affiliation': 'Laboratorio de Fisiología Comparada/Fisiología del Transporte de Oxígeno, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Damian M', 'Initials': 'DM', 'LastName': 'Bailey', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, Glamorgan, Wales.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stembridge', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Anholm', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, Loma Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Tymko', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC; Neurovascular Health Laboratory, Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC.'}]",Chest,['10.1016/j.chest.2021.08.075']
189,33994179,Different types of foot orthoses effect on gait mechanics in patients with rheumatoid arthritis.,"Foot orthoses are a first line conservative treatment for foot impairments in patients with rheumatoid arthritis (RA), however their effect on gait mechanics is poorly understood. We aimed to compare changes in lower limb and foot mechanics between two types of commonly used foot orthoses (FO) with a control. Twenty-seven patients with rheumatoid arthritis participated in this crossover study. Two different types of FO (a medially wedged custom-made FO and a prefabricated FO with a metatarsal dome, respectively), were compared against a control insole. During gait, lower limb mechanics were analyzed using 3D motion capture, force plates, and an in-shoe pressure system. Inverse dynamics models were created in the Anybody Modeling System to calculate joint angles and joint moments during gait. Gait variables were analyzed using statistical parametric mapping. Compared to the control, the prefabricated FO had limited effect on gait mechanics. Compared to the control the custom-made FO reduced ankle plantarflexion moment with 0.4 %body weight * body height (BW * BH) between 66 and 76% of stance and ankle eversion moment was reduced 0.16% BW*BH between 3 and 40% of stance. Furthermore, it also reduced the average forefoot plantar pressure by 9 kPa between 20 and 62% of stance compared to the control. Changes in foot pressure distribution, joint moments and angles were most pronounced for custom-made FO compared to the prefabricated FO. The findings suggest that patients with RA and foot impairments may benefit more from an individualized FO strategy, if the aim of the treatment is to alter gait mechanics. (NCT03561688).",2022,"Changes in foot pressure distribution, joint moments and angles were most pronounced for custom-made FO compared to the prefabricated FO.","['Twenty-seven patients with rheumatoid arthritis', 'patients with rheumatoid arthritis', 'patients with rheumatoid arthritis (RA']",[],"['stance and ankle eversion moment', 'ankle plantarflexion moment', 'gait mechanics', 'average forefoot plantar pressure', '\xa0body height (BW\xa0*\xa0BH', 'foot pressure distribution, joint moments and angles']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]",[],"[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",27.0,0.0278412,"Changes in foot pressure distribution, joint moments and angles were most pronounced for custom-made FO compared to the prefabricated FO.","[{'ForeName': 'Morten Bilde', 'Initials': 'MB', 'LastName': 'Simonsen', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, DK-9220 Aalborg East, Denmark; Centre for Clinical Research, North Denmark Regional Hospital, DK-9800 Hjoerring, Denmark.'}, {'ForeName': 'Rogerio Pessoto', 'Initials': 'RP', 'LastName': 'Hirata', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, DK-9220 Aalborg East, Denmark.'}, {'ForeName': 'Ketill', 'Initials': 'K', 'LastName': 'Næsborg-Andersen', 'Affiliation': 'Centre for Clinical Research, North Denmark Regional Hospital, DK-9800 Hjoerring, Denmark.'}, {'ForeName': 'Peter Derek Christian', 'Initials': 'PDC', 'LastName': 'Leutscher', 'Affiliation': 'Centre for Clinical Research, North Denmark Regional Hospital, DK-9800 Hjoerring, Denmark; Department of Clinical Medicine, Aalborg University, DK-9000 Aalborg, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hørslev-Petersen', 'Affiliation': 'Danish Hospital for Rheumatic Diseases, University of Southern Denmark, DK-6400 Sønderborg, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Woodburn', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, G4 0BA Glasgow, Scotland, UK.'}, {'ForeName': 'Michael Skipper', 'Initials': 'MS', 'LastName': 'Andersen', 'Affiliation': 'Department of Materials and Production, Aalborg University, DK-9220 Aalborg East, Denmark. Electronic address: msa@mp.aau.dk.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2021.110496']
190,34021270,Refractory Kawasaki disease: modified methylprednisolone regimen decreases coronary artery dilatation.,"BACKGROUND


The use of corticosteroids in Kawasaki disease (KD) is still controversial. The aim of this study was to investigate the safety and effectiveness of modified methylprednisolone (mPSL) regimen as an initial treatment for refractory KD.
METHODS


This is a real-world observational study. We identified refractory KD with a self-developed scoring system. Patients were divided into the intravenous immunoglobulin (IVIG) + mPSL group and the IVIG group. Clinical outcomes and changes in coronary arteries after the treatment during a 12-week period were observed. Propensity-score matching was used to analyze those patients with similar baseline characteristics.
RESULTS


Of a total of 168 patients, 104 patients were assigned into the IVIG group and 64 patients into the IVIG + mPSL group. The therapeutic response rate of the IVIG + mPSL group was significantly higher than that of the IVIG group (98.4 vs 76.0%, P < 0.05). The IVIG + mPSL group had a shorter duration of fever and a higher rate of C-reactive protein decline than the IVIG group (1.17 ± 0.64 vs 1.81 ± 1.16 days; 88.1 vs 83.5%; P < 0.05). The luminal diameter and Z-score of the left circumflex coronary artery (LCX) were significantly smaller and lower in the IVIG + mPSL group than that in the IVIG group at weeks 2 and 12.
CONCLUSIONS


Modified mPSL regimen has minimal side effects. It might improve the initial response to IVIG and decrease the dilation of LCX for refractory KD.
IMPACT


Modified mPSL regimen (2-4 mg/kg/day, divided into 2-3 doses for 3-5 days, then 1 mg/kg/day, once a day for 3-5 days, then oral prednisone was tapered over 3-5 weeks in 5-7 days steps) as an intensive initial treatment can decrease LCX dilation in high-risk IVIG-resistant KD patients. Our self-developed scoring system has been proven validated and can be used to identify high-risk IVIG-resistant KD patients in North China. The present study provides an alternative therapeutic regimen for high-risk refractory KD patients.",2022,The IVIG + mPSL group had a shorter duration of fever and a higher rate of C-reactive protein decline than the IVIG group (1.17 ± 0.64 vs 1.81 ± 1.16 days; 88.1 vs 83.5%; P < 0.05).,"['Kawasaki disease (KD', 'high-risk refractory KD patients', '104 patients were assigned into the IVIG group and 64 patients into the', '168 patients', 'Refractory Kawasaki disease']","['IVIG\u2009+\u2009mPSL', 'methylprednisolone', 'intravenous immunoglobulin (IVIG)\u2009+\u2009mPSL', 'corticosteroids', 'modified methylprednisolone (mPSL']","['shorter duration of fever', 'safety and effectiveness', 'coronary arteries', 'luminal diameter and Z-score of the left circumflex coronary artery (LCX', 'rate of C-reactive protein decline', 'coronary artery dilatation', 'therapeutic response rate', 'LCX dilation']","[{'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0226037', 'cui_str': 'Structure of circumflex branch of left coronary artery'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010051', 'cui_str': 'Aneurysm of coronary vessels'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",168.0,0.0301814,The IVIG + mPSL group had a shorter duration of fever and a higher rate of C-reactive protein decline than the IVIG group (1.17 ± 0.64 vs 1.81 ± 1.16 days; 88.1 vs 83.5%; P < 0.05).,"[{'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Children's Hospital Capital Institute of Pediatrics, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Department of Cardiology, Children's Hospital Capital Institute of Pediatrics, Beijing, China.""}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Children's Hospital Capital Institute of Pediatrics, Beijing, China. lxhmaggie@126.com.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Cardiology, Children's Hospital Capital Institute of Pediatrics, Beijing, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""Department of Cardiology, Children's Hospital Capital Institute of Pediatrics, Beijing, China.""}, {'ForeName': 'Aijie', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Children's Hospital Capital Institute of Pediatrics, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Children's Hospital Capital Institute of Pediatrics, Beijing, China.""}]",Pediatric research,['10.1038/s41390-021-01576-6']
191,34091518,Improving Medication Tolerance: A Pilot Study in Disorders of Gut-brain Interaction Treated With Tricyclic Antidepressants.,"OBJECTIVES


Tricyclic antidepressants (TCAs) are commonly used to treat disorders of gut-brain interaction (DGBI). However, these medications are often associated with side effects that lead to early treatment discontinuation. Research in other chronic medical conditions suggests that many TCA side effects may be caused by nocebo (negative placebo) effects. The current study tests a brief, verbal intervention aimed at improving tolerance of TCAs in DGBI by providing education about nocebo effects.
MATERIALS AND METHODS


This pilot randomized controlled trial was performed in a tertiary care gastroenterology clinic. Participants with DGBI were randomized ""standard information,"" describing the benefits and risks of TCAs, or ""augmented information,"" which included an additional <30-second education about nocebo effects. Two weeks after their visit, participants were emailed a survey evaluating the number and bothersomeness of side effects, adequate relief, global improvement, and treatment satisfaction.
RESULTS


Thirty-one patients were randomized and 22 responded to the survey. The average age was 40% and 59% were women. Although not statistically significant, the augmented group attributed nominally fewer symptoms to TCAs than the standard group, with a medium effect size (1.5 vs. 4.2, effect size d=0.56, P=0.212) and reported being significantly less bothered by those symptoms (13.4 vs. 38.1, P=0.037). A nominally larger percentage of the augmented group reported adequate relief of symptoms after 2 weeks of treatment compared with the standard group (55% vs. 27%, respectively).
CONCLUSIONS


This pilot study demonstrates that a brief (≈30 s) clinical intervention addressing nocebo effects may improve tolerance of TCAs. These findings provide support for future, fully powered studies to evaluate the impact of framing on clinical outcomes, especially in chronic conditions.",2022,"Although not statistically significant, the augmented group attributed nominally fewer symptoms to TCAs than the standard group, with a medium effect size (1.5 vs. 4.2, effect size d=0.56, P=0.212) and reported being significantly less bothered by those symptoms (13.4 vs. 38.1, P=0.037).","['Thirty-one patients were randomized and 22 responded to the survey', 'tertiary care gastroenterology clinic', 'Participants with DGBI']","['Tricyclic Antidepressants', 'Tricyclic antidepressants (TCAs']","['number and bothersomeness of side effects, adequate relief, global improvement, and treatment satisfaction', 'Improving Medication Tolerance', 'adequate relief of symptoms']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C3834491', 'cui_str': 'Gastroenterology clinic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]","[{'cui': 'C0003290', 'cui_str': 'Tricyclic antidepressant'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",31.0,0.0291312,"Although not statistically significant, the augmented group attributed nominally fewer symptoms to TCAs than the standard group, with a medium effect size (1.5 vs. 4.2, effect size d=0.56, P=0.212) and reported being significantly less bothered by those symptoms (13.4 vs. 38.1, P=0.037).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ballou', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Iturrino', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Rangan', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Cheng', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kelley', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Nee', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001575']
192,34494032,Estimation of Vaccine Efficacy for Variants that Emerge After the Placebo Group Is Vaccinated.,"SARS-CoV-2 continues to evolve and the vaccine efficacy against variants is challenging to estimate. It is now common in phase III vaccine trials to provide vaccine to those randomized to placebo once efficacy has been demonstrated, precluding a direct assessment of placebo controlled vaccine efficacy after placebo vaccination. In this work we extend methods developed for estimating vaccine efficacy post placebo vaccination to allow variant specific time varying vaccine efficacy, where time is measured since vaccination. The key idea is to infer counterfactual strain specific placebo case counts by using surveillance data that provide the proportions of the different strains. This blending of clinical trial and observational data allows estimation of strain-specific time varying vaccine efficacy, or sieve effects, including for strains that emergent after placebo vaccination. The key requirements are that surveillance strain distribution accurately reflect the strain distribution for a placebo group, throughout follow-up after placebo group vaccination and that at least one strain is present before and after placebo vaccination. For illustration, we develop a Poisson approach for an idealized design under a rare disease assumption and then use a proportional hazards modeling to better reflect the complexities of field trials with staggered entry, crossover, and smoothly varying strain specific vaccine efficacy We evaluate these by theoretical work and simulations, and demonstrate that useful estimation of the efficacy profile is possible for strains that emerge after vaccination of the placebo group. An important principle is to incorporate sensitivity analyses to guard against mis-specfication of the strain distribution. We also provide an approach for use when genotyping of the infecting strains of the trial participants has not been done.",2021,"In this work we extend methods developed for estimating vaccine efficacy post placebo vaccination to allow variant specific time varying vaccine efficacy, where time is measured since vaccination.",[],"['placebo vaccination', 'placebo', 'Placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.602573,"In this work we extend methods developed for estimating vaccine efficacy post placebo vaccination to allow variant specific time varying vaccine efficacy, where time is measured since vaccination.","[{'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Follmann', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fay', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Magaret', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gilbert', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2021.08.31.21262908']
193,34518652,Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials.,"BACKGROUND


Fatigue is a multifactorial symptom commonly reported by patients with prostate cancer as a result of disease and treatment. This study assesses the impact enzalutamide has on patient-reported fatigue (""fatigue"") by using patient-reported outcomes from four pivotal, placebo-controlled trials of enzalutamide (ARCHES (NCT02677896), PROSPER (NCT02003924), PREVAIL (NCT01212991), and AFFIRM (NCT00974311)).
METHODS


Fatigue was assessed in the individual studies using the Functional Assessment of Cancer Therapy-Prostate item GP1 at baseline, weeks 13 or 17, and every 12 weeks until disease progression. Longitudinal changes were assessed using mean scores and mixed-model repeated measures.
RESULTS


The fatigue rates at baseline were higher in patients with later-stage disease (metastatic and/or castration-resistant prostate cancer (CRPC)) and among patients who had already received prior treatment lines; rates ranged between 58% in PROSPER (nonmetastatic CRPC) and 86% in AFFIRM (post-docetaxel metastatic CRPC). Irrespective of disease state, initiation of enzalutamide or placebo resulted in an early increase of fatigue (by weeks 13 or 17), with fatigue levels stabilizing thereafter. At last assessment, ≥55% of patients reported fatigue improvement or stabilization in all trials compared to baseline. More patients reported fatigue worsening by ≥1 or ≥2 units with enzalutamide plus androgen deprivation therapy (ADT) than with placebo plus ADT in ARCHES, PROSPER, and PREVAIL, but the between-group difference was <10% in all trials.
CONCLUSIONS


The levels of fatigue were greater in mCRPC and lower in earlier states of disease. In all trials, patients reported a small increase in fatigue for the first 13-17 weeks after starting enzalutamide or placebo, with slightly greater fatigue with enzalutamide in all studies except AFFIRM, but fatigue stabilized or improved thereafter. This suggests a role for clinical management of fatigue to help patients cope early in treatment.",2022,"In all trials, patients reported a small increase in fatigue for the first 13-17 weeks after starting enzalutamide or placebo, with slightly greater fatigue with enzalutamide in all studies except AFFIRM, but fatigue stabilized or improved thereafter.",['patients with prostate cancer'],"['placebo', 'enzalutamide', 'placebo plus ADT', 'enzalutamide or placebo', 'enzalutamide plus androgen deprivation therapy (ADT']","['levels of fatigue', 'fatigue rates', 'fatigue worsening', 'fatigue improvement or stabilization', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]",,0.603803,"In all trials, patients reported a small increase in fatigue for the first 13-17 weeks after starting enzalutamide or placebo, with slightly greater fatigue with enzalutamide in all studies except AFFIRM, but fatigue stabilized or improved thereafter.","[{'ForeName': 'Bertrand F', 'Initials': 'BF', 'LastName': 'Tombal', 'Affiliation': 'Urology, Cliniques universitaires Saint-Luc, UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Urology, Center for Integrated Research in Cancer and Lifestyle, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'School of Medicine, Duke Cancer Institute Center for Prostate & Urologic Cancers, Durham, NC, USA.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'Hematology/Medical Oncology, OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Urology, University Hospital, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Medical Oncology, Weill Cornell Medicine, Meyer Cancer Center, New York, NY, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Medicine, Lurie Cancer Center, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Ganguli', 'Affiliation': 'HEOR, Astellas Pharma Inc, Northbrook, IL, USA.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramaswamy', 'Affiliation': 'HEOR, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Bhadauria', 'Affiliation': 'Medical Affairs, Astellas Pharma Inc., Northbrook, IL, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ivanescu', 'Affiliation': 'Statistics, IQVIA, Amsterdam-Zuidoost, the Netherlands.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Turnbull', 'Affiliation': 'Patient Centered Endpoints, IQVIA, New York, NY, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Holmstrom', 'Affiliation': 'HEOR, Astellas Pharma Inc., Leiden, the Netherlands.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'Urology, University of Montréal Hospital Center, Montréal, QC, Canada. fred.saad@umontreal.ca.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00447-9']
194,34486579,Prediction of the trabecular iris angle after posterior chamber phakic intraocular lens implantation.,"PURPOSE


To create an equation for predicting the trabecular iris angle (TIA) and to verify its accuracy after implantable collamer lens (ICL) implantation.
SETTING


Nagoya Eye Clinic, Nagoya, Japan.
DESIGN


Retrospective evaluation of a screening approach.
METHODS


174 eyes (174 patients) that underwent ICL implantation were included. Patients were randomly assigned to the prediction equation group (116 eyes) or verification group (58 eyes). Anterior segment optical coherence tomography (AS-OCT) (CASIA2 TOMEY) was performed before and 3 months after ICL surgery. For the prediction group, a prediction equation was created with the preoperative AS-OCT parameters and ICL size as independent variables and the postoperative anterior chamber depth (ACD) as the dependent variable. Then, by applying the predicted post-ACD and preoperative AS-OCT parameters as independent variables and TIA after ICL surgery as the dependent variable, a prediction equation was created to predict the postoperative TIA (post-TIA) after ICL surgery. Each prediction equation was created using stepwise multiple regression analysis, and its accuracy was verified by a Bland-Altman plot in the verification group.
RESULTS


The explanatory variables (standardized partial regression coefficient) selected in the post-TIA prediction equation were post-ACD (0.629), TIA750 (0.563), iris curvature (0.353), pupil diameter (-0.281), iris area (-0.249), and trabecular iris space area 250 (-0.171) (R2 = 0.646) (n = 116). There were no clinically significant systematic errors between measured and predictive post-TIA values in the verification group (n = 58). The mean absolute prediction error was 3.43 ± 2.22 degrees.
CONCLUSIONS


Post-TIA was accurately predicted from the predicted post-ACD and other preoperative AS-OCT parameters.",2022,There were no clinically significant systematic errors between measured and predictive post-TIA values in the verification group.,"['Nagoya Eye Clinic, Nagoya, Japan', 'subjects included 174 eyes (174 patients) that underwent']","['implantable collamer lens (ICL) implantation', 'posterior chamber phakic intraocular lens implantation', 'ICL implantation', 'Anterior segment optical coherence tomography (AS-OCT']","['iris curvature (0.353), pupil diameter (-0.281), iris area (-0.249), and trabecular iris space area 250', 'postoperative anterior chamber depth (ACD']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1532778', 'cui_str': 'Posterior chamber phakic intraocular lens'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}]",,0.0617639,There were no clinically significant systematic errors between measured and predictive post-TIA values in the verification group.,"[{'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'From the Nagoya Eye Clinic, Nagoya, Aichi, Japan (Nishida, Kojima, Kataoka, Isogai, Yoshida, Nakamura); the Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan (Kojima).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kojima', 'Affiliation': ''}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Isogai', 'Affiliation': ''}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': ''}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000804']
195,34486577,Effect of decentration on the quality of vision: comparison between aspheric balance curve design and posterior aspheric design intraocular lenses.,"PURPOSE


To study the effect of decentration on the quality of vision in 2 aspheric intraocular lenses (IOLs): aspheric balance curve (ABC) design Vivinex iSert XY1 (Hoya Surgical Opticals, Inc.) and posterior aspheric design AcrySof IQ SN60WF (Alcon Laboratories, Inc.).
SETTING


Advanced Eye Centre, PGIMER, Chandigarh, India.
DESIGN


Randomized prospective trial using a random number table.
METHODS


85 eyes were randomized to group 1 (Vivinex XY1) and group 2 (AcrySof IQ) with 40 and 45 eyes, respectively. The higher-order aberration (HOA) profile, Strehl ratio, decentration of the IOL from the visual axis (decentration from the visual axis [DVA]) and the geometric axis (decentration from the geometric axis [DGA]), angle α, and κ were recorded on the iTrace aberrometer, and contrast sensitivity was measured using the Functional Acuity Contrast Test at 12 weeks postsurgery.
RESULTS


A total of 85 eyes in 60 patients were evaluated in this study. The mean values of the Strehl ratio (P = .48) and the HOAs (P = .12) of both IOLs were comparable. The HOAs gradually increased with increasing DVA for both lenses at 3.0 mm, 4.0 mm, and 5.0 mm pupil sizes. On comparing the HOAs with the DGA, a statistically insignificant positive correlation was observed. The Strehl ratio did not deteriorate with an increasing angle α in the Vivinex XY1 group; however, it worsened in the AcrySof IQ group. Contrast sensitivity was comparable in both the IOLs except at 1.5 cycles per degree under photopic conditions where the AcrySof IQ was better.
CONCLUSIONS


Decentration of the lens was best measured with respect to the visual axis. In eyes with a large α, the ABC design induced lesser HOAs and maintained a better Strehl ratio.",2022,"The Strehl's ratio did not deteriorate with increasing angle alpha in the Vivinex XY1 group, however worsened in the Acrysof IQ group.","['Eighty-five eyes', 'Advanced Eye Centre, PGIMER, Chandigarh, India']",['posterior aspheric design'],"[""HOA profile, Strehl's ratio, decentration of IOL from the visual axis (DVA) and the geometric axis (DGA), angle Alpha and Kappa"", ""mean values of the Strehl's ratio"", ""HOA's"", 'contrast sensitivity', 'quality of vision']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",85.0,0.0359624,"The Strehl's ratio did not deteriorate with increasing angle alpha in the Vivinex XY1 group, however worsened in the Acrysof IQ group.","[{'ForeName': 'Kedarisetti Kiran', 'Initials': 'KK', 'LastName': 'Chandra', 'Affiliation': 'From the Advanced Eye Centre, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India.'}, {'ForeName': 'Chintan', 'Initials': 'C', 'LastName': 'Malhotra', 'Affiliation': ''}, {'ForeName': 'Arun Kumar', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': ''}, {'ForeName': 'Kulbhushan', 'Initials': 'K', 'LastName': 'Sachdeva', 'Affiliation': ''}, {'ForeName': 'Shubhi', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000810']
196,34525847,Connection During COVID-19: Pilot Study of a Telehealth Group Parenting Intervention.,"OBJECTIVE


The COVID-19 pandemic has resulted in considerable stress for families, placing parents at risk for heightened psychological distress, while prompting widespread changes in mental health service delivery. This study evaluated treatment engagement, acceptability, and psychiatric distress among participants in the telehealth adaptation of the Connecting and Reflecting Experience (CARE) program after the onset of COVID-19.
METHODS


CARE is a transdiagnostic, bigenerational, mentalizing-focused group parenting intervention based out of an outpatient child mental health clinic in an underserved urban community. Individuals participating in CARE during the clinic's transition to telehealth services were recruited for participation in this pre-post design pilot study. Participants (N=12) completed self-report surveys before and after their first telehealth group session and at their 20-week follow-up. Quantitative and qualitative measures were used to evaluate psychiatric symptoms, treatment engagement, and preliminary acceptability of the adaptation.
RESULTS


Self-reported mood and anxiety symptoms decreased significantly after 20 weeks of telehealth therapy. Participants reported high levels of therapeutic alliance and group cohesion in the telehealth format. Results also showed minimal participant-reported privacy concerns and a trend toward increased treatment engagement.
CONCLUSIONS


These findings have implications regarding the acceptability of teletherapy interventions for caregivers of children during this period of heightened vulnerability and limited access to social support and health services. They also are relevant to establishing the preliminary acceptability of mentalizing-focused parenting inventions delivered via telehealth.",2022,Self-reported mood and anxiety symptoms decreased significantly after 20 weeks of telehealth therapy.,"[""Individuals participating in CARE during the clinic's transition to telehealth services"", 'participants in the telehealth adaptation of the Connecting and Reflecting Experience (CARE) program after the onset of COVID-19', 'outpatient child mental health clinic in an underserved urban community']","['teletherapy interventions', 'Telehealth Group Parenting Intervention']","['high levels of therapeutic alliance', 'Self-reported mood and anxiety symptoms', 'acceptability, and psychiatric distress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4520476', 'cui_str': 'Telehealth service'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.015772,Self-reported mood and anxiety symptoms decreased significantly after 20 weeks of telehealth therapy.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zayde', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Montefiore Medical Center, New York City (all authors); Division of Clinical Research, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York (Gabbay).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kilbride', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Montefiore Medical Center, New York City (all authors); Division of Clinical Research, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York (Gabbay).'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Kucer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Montefiore Medical Center, New York City (all authors); Division of Clinical Research, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York (Gabbay).'}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Willis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Montefiore Medical Center, New York City (all authors); Division of Clinical Research, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York (Gabbay).'}, {'ForeName': 'Adella', 'Initials': 'A', 'LastName': 'Nikitiades', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Montefiore Medical Center, New York City (all authors); Division of Clinical Research, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York (Gabbay).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Alpert', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Montefiore Medical Center, New York City (all authors); Division of Clinical Research, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York (Gabbay).'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Gabbay', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Montefiore Medical Center, New York City (all authors); Division of Clinical Research, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York (Gabbay).'}]",American journal of psychotherapy,['10.1176/appi.psychotherapy.20210005']
197,34561872,Simultaneous use of high-volume Foley catheter (60 ml) and misoprostol for labor induction in nulliparous women: A randomized controlled trial.,"OBJECTIVE


To examine the simultaneous effect of high-volume Foley catheter (HVFC) (60 ml) and vaginal misoprostol on labor induction in nulliparous women.
METHODS


A randomized, double-blind, controlled trial was conducted among nulliparous post-date (>40 weeks) pregnant women between June and December 2019. At enrollment 100 women were randomized into each group (either HVFC and vaginal misoprostol or low-volume Foley catheter [LVFC] [30 ml] and vaginal misoprostol), for labor induction. Demographic and clinical data were collected at enrollment and delivery.
RESULTS


Women in the HVFC group had statistically significantly shorter induction to delivery interval (median 860 min, interquartile range [IQR] 840-940 min vs. 1160 min, IQR 1080-1320 min, P < 0.001) and duration of labor (median 615 min, IQR 600-680 min vs. 750, IQR 692.5-800 min, P < 0.001). Mode of vaginal delivery (n = 94 vs. n = 78, P = 0.002), number of doses of misoprostol required (median 2, IQR 1-2 vs. 2, IQR 1-3), and need of oxytocin augmentation (n = 22 vs. n = 39, P = 0.014 and P < 0.001), was significantly better in the HVFC group. However, there was no significant difference with respect to other maternal or neonatal outcomes.
CONCLUSION


Simultaneous use of HVFC and vaginal misoprostol for labor induction significantly shortens the induction to delivery interval and duration of labor in nulliparous women.
TRIAL REGISTRATION


Clinical Trial Registry of India CTRI/2019/05/019394 (http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=31554&EncHid=&userName=Foley%20catheter).",2022,"Additionally, mode of vaginal delivery (n; 94 vs 78, p value 0.002), number of doses of misoprostol required (median [IQR]; 2[1-2] vs 2 [1-3]) & need of oxytocin augmentation (n; 22 vs 39, p value 0.014) &, p value <0.001), was significantly better in HVFC group.","['nulliparous post date (>40 weeks POG) pregnant women between June to December 2019', 'nulliparous women', 'At enrolment 100 women']","['high volume Foley catheter (60 ml) and misoprostol', 'HVFC & vaginal misoprostol or low volume Foley catheter [LVFC] (30 ml) & vaginal misoprostol', 'HVFC & vaginal misoprostol', 'high-volume Foley catheter [HVFC] (60 ml) & vaginal misoprostol', 'HVFC']","['need of oxytocin augmentation', 'induction delivery interval & duration of labor', 'duration of labor', 'shorter induction delivery interval', 'number of doses of misoprostol required']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0032993', 'cui_str': 'Post-term pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]",100.0,0.237129,"Additionally, mode of vaginal delivery (n; 94 vs 78, p value 0.002), number of doses of misoprostol required (median [IQR]; 2[1-2] vs 2 [1-3]) & need of oxytocin augmentation (n; 22 vs 39, p value 0.014) &, p value <0.001), was significantly better in HVFC group.","[{'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Soni', 'Affiliation': 'Department of Obstetrics & Gynecology, Dr Rajendra Prasad Government Medical College, Kangra at Tanda, HP, India.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics & Gynecology, Dr Rajendra Prasad Government Medical College, Kangra at Tanda, HP, India.'}, {'ForeName': 'Chanderdeep', 'Initials': 'C', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics & Gynecology, Dr Rajendra Prasad Government Medical College, Kangra at Tanda, HP, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Obstetrics & Gynecology, Dr Rajendra Prasad Government Medical College, Kangra at Tanda, HP, India.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13943']
198,34561362,Evaluation of ophthalmic surgical simulators for continuous curvilinear capsulorhexis training.,"PURPOSE


To evaluate performance and assessments by expert surgeons tasked to create a continuous curvilinear capsulorhexis (CCC) on 3 commercially available surgical simulators.
SETTING


Montefiore Medical Center Department of Ophthalmology and Visual Sciences, Bronx, New York.
DESIGN


Randomized, cross-sectional, comparative study.
METHODS


Expert cataract surgeons (N = 7) were tasked to create a 5.5-mm CCC on 3 surgical simulators (Bioniko, Kitaro, and SimulEYE). Surgeons rated how well each simulator approximated human tissue on a modified Likert scale (1 to 7). Duration, size, and number of forceps grabs were evaluated.
RESULTS


7 surgeons performed a total of 63 trials. Bioniko required a greater number (6.53 ± 3.14) of forceps grabs for CCC creation than Kitaro (4.90 ± 2.47, P = .01) and SimulEYE (3.90 ± 1.34, P < .0001). Surgeons created the 5.5-mm CCC most accurately on Bioniko and SimulEYE, with the largest mean CCC performed on Kitaro (8.00 ± 0.84) compared with that on Bioniko (5.24 ± 0.60, P < .0001) and SimulEYE (5.11 ± 0.41, P < .0001). Surgeons spent more time (seconds) performing the CCC on Bioniko (41.95 ± 26.70) than that on Kitaro (32.05 ± 14.99, P = .02) and SimulEYE (28.90 ± 15.18, P = .002). Kitaro (4.56 ± 0.84, P < .0001) and SimulEYE (4.19 ± 0.92, P < .0001) were rated as more realistic than Bioniko (1.38 ± 0.80).
CONCLUSIONS


SimulEYE and Kitaro were believed to most closely approximate human capsular tissue, and surgeons performed the CCC fastest on these models. However, surgeons created a 5.5-mm CCC most accurately on SimulEYE and Bioniko. SimulEYE had the best overall performance and fidelity across all studied metrics; however, each simulator demonstrated its own unique advantages and disadvantages. Larger validation studies will help residency programs best use training tools for novice surgeons.",2022,"SimulEYE™ had the best overall performance and fidelity across all studied metrics, however each simulator demonstrated its own unique advantages and disadvantages.","['Expert cataract surgeons (N=7) were', 'Continuous Curvilinear Capsulorhexis Training']","['continuous curvilinear capsulorhexis (CCC', 'tasked to create a 5.5 millimeter (mm) CCC on three surgical simulators (BionikoTM, KitaroTM, and SimulEYETM']","['Surgeons spent more time (seconds) performing the CCC on Bioniko™', 'Duration, size, and number of forceps grabs']","[{'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0525027', 'cui_str': 'Anterior capsulorrhexis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0525027', 'cui_str': 'Anterior capsulorrhexis'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439200', 'cui_str': 'mm'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0525027', 'cui_str': 'Anterior capsulorrhexis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}]",7.0,0.0845851,"SimulEYE™ had the best overall performance and fidelity across all studied metrics, however each simulator demonstrated its own unique advantages and disadvantages.","[{'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Raval', 'Affiliation': 'From the Department of Ophthalmology and Visual Sciences, Montefiore Medical Center, Bronx, New York (Raval, Shrivastava); Albert Einstein College of Medicine, Bronx, New York (Hawn); Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, New York (Kim, Xie).'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Hawn', 'Affiliation': ''}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Shrivastava', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000820']
199,34534029,The State-Trait Cheerfulness Inventory State Version-Short Form (STCI-S18): An Examination of Language Use and Psychometric Properties.,"The State-Trait Cheerfulness Inventory-State Version (STCI-S) measures three states of cheerfulness, seriousness, and bad mood as the temperamental basis of humor. The present study investigates (1) the development and psychometric validation of a newly developed short version and (2) test-criterion validity with state measures and language use. Study 1 ( N  = 933) confirmed the three-dimensional structure, and both the short and standard versions demonstrated strong psychometric properties. Study 2 ( N  = 617) replicated these findings in a separate sample. Study 3 ( N  = 750) demonstrated expected intercorrelations with self-report state measures (i.e., inspiration, self-esteem, depression, anxiety). Participants were randomized to expressive writing conditions (i.e., writing about a retrospective cheerful, serious, or bad mood scenario). Unacquainted judges' and participants' ratings of three states in their respective scenarios converged (.44 <  r  < .62). Retrospective states cheerfulness, seriousness, and bad mood were associated with linguistic categories (e.g., emotional tone, clout, achievement, insight) identified in the Linguistic Inquiry and Word Count (LIWC) software. The impact of personality states on word usage may only be evident in specific contexts and situations. Presence of distinctive language use in these writing samples further demonstrated test-criterion validity and practicality of the STCI-S18.",2022,"Study 1 ( N  = 933) confirmed the three-dimensional structure, and both the short and standard versions demonstrated strong psychometric properties.",[],"['expressive writing conditions', 'State-Trait Cheerfulness Inventory State Version-Short Form (STCI-S18']","['intercorrelations with self-report state measures (i.e., inspiration, self-esteem, depression, anxiety', 'linguistic categories (e.g., emotional tone, clout, achievement, insight) identified in the Linguistic Inquiry and Word Count (LIWC) software']",[],"[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0037585', 'cui_str': 'Software'}]",,0.129444,"Study 1 ( N  = 933) confirmed the three-dimensional structure, and both the short and standard versions demonstrated strong psychometric properties.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Lau', 'Affiliation': 'Department of Psychology, Western University, London, Canada.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Chiesi', 'Affiliation': ""Department of Neuroscience, Psychology, Drug, and Child's Health (NEUROFARBA), Section of Psychology, University of Florence, Florence, Italy.""}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Saklofske', 'Affiliation': 'Department of Psychology, Western University, London, Canada.'}, {'ForeName': 'Willibald', 'Initials': 'W', 'LastName': 'Ruch', 'Affiliation': 'Personality and Assessment, Department of Psychology, University of Zurich, Zurich, Switzerland.'}]",Journal of personality assessment,['10.1080/00223891.2021.1955694']
200,34561393,Transcranial direct current stimulation of 3 cortical targets is no more effective than placebo as treatment for fibromyalgia: a double-blind sham-controlled clinical trial.,"ABSTRACT


Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and the dorsolateral prefrontal cortex seem to improve pain and other symptoms of fibromyalgia (FM), although the evidence on the effectiveness of tDCS and the optimal stimulation target is not robust enough. Our main objective was to establish the optimal area of stimulation, comparing the 2 classical targets and a novel pain-related area, the operculo-insular cortex, in a sham-controlled trial. Using a double-blind design, we randomly assigned 130 women with FM to 4 treatment groups (M1, dorsolateral prefrontal cortex, operculo-insular cortex, and sham), each receiving fifteen 20-minute sessions of 2 mA anodal tDCS over the left hemisphere. Our primary outcome was pain intensity. The secondary outcomes were the other core symptoms of FM (fatigue, mood, cognitive and sleep disorders, and hyperalgesia measured by the pressure pain threshold). We performed the assessment at 3 time points (before, immediately after treatment, and at 6 months follow-up). The linear mixed-model analysis of variances showed significant treatment effects across time for clinical pain and for fatigue, cognitive and sleep disturbances, and experimental pain, irrespective of the group. In mood, the 3 active tDCS groups showed a significantly larger improvement in anxiety and depression than sham. Our findings provide evidence of a placebo effect, support the use of tDCS for the treatment of affective symptoms, and challenge the effectiveness of tDCS as treatment of FM.",2022,"The linear mixed-model ANOVAs showed significant treatment effects across time for clinical pain and for fatigue, cognitive and sleep disturbances, and experimental pain, irrespective of the group.","['fibromyalgia', '130 women with']","['FM to four treatment groups (M1, DLPFC, OIC, Sham), each receiving fifteen 20-minute sessions of 2mA anodal tDCS', 'placebo', 'tDCS', 'Transcranial Direct Current Stimulation (tDCS']","['core symptoms of FM (fatigue, mood, cognitive and sleep disorders, hyperalgesia measured by pressure pain threshold', 'anxiety and depression', 'pain intensity', 'clinical pain and for fatigue, cognitive and sleep disturbances, and experimental pain']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",130.0,0.404355,"The linear mixed-model ANOVAs showed significant treatment effects across time for clinical pain and for fatigue, cognitive and sleep disturbances, and experimental pain, irrespective of the group.","[{'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Samartin-Veiga', 'Affiliation': 'Brain and Pain (BaP) Lab, Departamento de Psicoloxía Clínica y Psicobioloxía, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pidal-Miranda', 'Affiliation': 'Brain and Pain (BaP) Lab, Departamento de Psicoloxía Clínica y Psicobioloxía, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'González-Villar', 'Affiliation': 'Department of Basic Psychology, Psychological Neuroscience Lab, Research Center in Psychology, School of Psychology, University of Minho, Braga, Portugal.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bradley', 'Affiliation': 'Inserm U 1028, NeuroPain Team, Neuroscience Research Center of Lyon (CRNL), Lyon-1 University, Bron, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Larrea', 'Affiliation': 'Inserm U 1028, NeuroPain Team, Neuroscience Research Center of Lyon (CRNL), Lyon-1 University, Bron, France.'}, {'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': ""O'Brien"", 'Affiliation': 'Independent researcher, Boston, MA, United States.'}, {'ForeName': 'María T', 'Initials': 'MT', 'LastName': 'Carrillo-de-la-Peña', 'Affiliation': 'Brain and Pain (BaP) Lab, Departamento de Psicoloxía Clínica y Psicobioloxía, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.'}]",Pain,['10.1097/j.pain.0000000000002493']
201,34530482,Apixaban and Dalteparin for the Treatment of Venous Thromboembolism in Patients with Different Sites of Cancer.,"Efficacy and safety of anticoagulant treatment for venous thromboembolism (VTE) may vary in patients with different cancer sites. We evaluated the rates of VTE recurrence and major bleeding and the relative efficacy and safety of 6-month treatment with oral apixaban or subcutaneous dalteparin in patients with different cancer sites randomized in the Caravaggio study. Primary cancer was located at gastrointestinal sites in 375 patients (32.5%), lung in 200 (17.3%), breast in 155 (13.4%), genitourinary sites in 139 (12%), gynecological sites in 119 (10.3%), and was hematological in 85 patients (7.4%). Rates of VTE recurrence were 10.9% in patients with gynecological, 8.8% with gastrointestinal, 6.5% with genitourinary, and 5.5% with lung cancer with lower rates in the other sites of cancer. Rates of major bleeding were 7.2% in patients with genitourinary and 4.8% with gastrointestinal cancer, with lower rates in patients with other sites of cancer. The observed absolute risk difference in VTE recurrence in favor of apixaban was 11.9% in patients with gynecological, 5.5% with lung, 3.7% with genitourinary cancer, and 0.6% with gastrointestinal cancer. None of the risk differences was statistically significant. The rates of major bleeding in patients treated with apixaban or dalteparin was similar across patients with different cancer sites. In conclusion, recurrences appear to be more common in patients with gastrointestinal and gynecological cancer and major bleedings in patients with genitourinary and gastrointestinal cancer. Oral apixaban is a valid oral alternative to subcutaneous dalteparin for the treatment of a large spectrum of patients with cancer-associated VTE.",2022,"Rates of major bleeding were 7.2% in patients with genitourinary and 4.8% with gastrointestinal cancer, with lower rates in patients with other sites of cancer.","['patients with genitourinary and gastrointestinal cancer', 'patients with different cancer sites', 'patients with different cancer sites randomized in the Caravaggio study', 'patients with cancer-associated VTE', 'Patients with Different Sites of Cancer']","['Oral apixaban', 'anticoagulant treatment', 'apixaban or dalteparin', 'Apixaban and Dalteparin', 'dalteparin', 'oral apixaban or subcutaneous dalteparin']","['rates of VTE recurrence and major bleeding', 'rates of major bleeding', 'Rates of major bleeding', 'VTE recurrence', 'Rates of VTE recurrence', 'Efficacy and safety', 'gynecological sites', 'genitourinary sites', 'Venous Thromboembolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C2945843', 'cui_str': 'Site of'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206461', 'cui_str': 'Dalteparin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}]",375.0,0.113892,"Rates of major bleeding were 7.2% in patients with genitourinary and 4.8% with gastrointestinal cancer, with lower rates in patients with other sites of cancer.","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Agnelli', 'Affiliation': 'Internal Vascular and Emergency Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Muñoz', 'Affiliation': 'Medical Oncology Department, Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Franco', 'Affiliation': 'Internal Vascular and Emergency Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mahé', 'Affiliation': 'Department of Internal Medicine, Hôpital Louis Mourier, University Paris 7, Colombes, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brenner', 'Affiliation': 'Department of Hematology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""Hematology Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States.""}, {'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Gussoni', 'Affiliation': 'Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan, Italy.'}, {'ForeName': 'Eva N', 'Initials': 'EN', 'LastName': 'Hamulyak', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Haemostasis and Thrombosis Unit, Division of Hematology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Maria Rosales', 'Initials': 'MR', 'LastName': 'Suero', 'Affiliation': 'Surgical Oncology Department, Institut Português Oncologie, Porto FG, EPE, Porto, Portugal.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, Germany.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Torbicki', 'Affiliation': 'Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, Center for Postgraduate Medical Education, ECZ-Otwock, Poland.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Becattini', 'Affiliation': 'Internal Vascular and Emergency Medicine, University of Perugia, Perugia, Italy.'}]",Thrombosis and haemostasis,['10.1055/s-0041-1735194']
202,34533477,Do We Need to Stabilize All Reduced Metaphyseal Both-bone Forearm Fractures in Children with K-wires?,"BACKGROUND


Short-term follow-up studies have shown that reduced metaphyseal both-bone forearm fractures in children should be treated with K-wires to prevent redisplacement and inferior functional results. Minimum 5-year follow-up studies are limited. Range of motion, patient-reported outcome measures, and radiographic parameters at minimum 5-year follow-up should be evaluated because they could change insights into how to treat pediatric metaphyseal forearm fractures.
QUESTIONS/PURPOSES


(1) Does K-wire stabilization of reduced metaphyseal both-bone forearm fractures in children provide better forearm rotation at minimum 5-year follow-up? (2) Do malunions (untreated redisplaced fractures) of reduced metaphyseal both-bone forearm fractures in children induce worse functional results? (3) Which factors lead to limited forearm rotation at minimum 5-year follow-up?
METHODS


We analyzed the extended minimum 5-year follow-up of a randomized controlled trial in which children with a reduced metaphyseal both-bone forearm fracture were randomized to either an above-elbow cast (casting group) or fixation with K-wires and an above-elbow cast (K-wire group). Between January 2006 and December 2010, 128 patients were included in the original randomized controlled trial: 67 in the casting group and 61 in the K-wire group. For the current study, based on an a priori calculation, it was determined that, with an anticipated mean limitation in prosupination (forearm rotation) of 7° ± 7° in the casting group and 3° ± 5° in the K-wire group, a power of 80% and a significance of 0.05, the two groups should consist of 50 patients each. Between January 2014 and May 2016, 82% (105 of 128) of patients were included, with a mean follow-up of 6.8 ± 1.4 years: 54 in the casting group and 51 in the K-wire group. At trauma, patients had a mean age of 9 ± 3 years and had mean angulations of the radius and ulna of 25° ± 14° and 23° ± 18°, respectively. The primary result was limitation in forearm rotation. Secondary outcome measures were radiologic assessment, patient-reported outcome measures (QuickDASH and ABILHAND-kids), handgrip strength, and VAS score for cosmetic appearance. Assessments were performed by the first author (unblinded). Multivariable logistic regression analysis was performed to analyze which factors led to a clinically relevant limitation in forearm rotation.
RESULTS


There was a mean limitation in forearm rotation of 5° ± 11° in the casting group and 5° ± 8° in the K-wire group, with a mean difference of 0.3° (95% CI -3° to 4°; p = 0.86). Malunions occurred more often in the casting group than in the K-wire group: 19% (13 of 67) versus 7% (4 of 61) with an odds ratio of 0.22 for K-wiring (95% CI 0.06 to 0.80; p = 0.02). In patients in whom a malunion occurred (malunion group), there was a mean limitation in forearm rotation of 6° ± 16° versus 5° ± 9° in patients who did not have a malunion (acceptable alignment group), with a mean difference 0.8° (95% CI -5° to 7°; p = 0.87). Factors associated with a limited forearm rotation ≥ 20° were a malunion after above-elbow casting (OR 5.2 [95% CI 1.0 to 27]; p = 0.045) and a refracture (OR 7.1 [95% CI 1.4 to 37]; p = 0.02).
CONCLUSION


At a minimum of 5 years after injury, in children with a reduced metaphyseal both-bone forearm fracture, there were no differences in forearm rotation, patient-reported outcome measures, or radiographic parameters between patients treated with only an above-elbow cast compared with those treated with additional K-wire fixation. Redisplacements occurred more often if treated by an above-elbow cast alone. If fracture redisplacement is not treated promptly, this leads to a malunion, which is a risk factor for a clinically relevant (≥ 20°) limitation in forearm rotation at minimum 5-year follow-up. Children with metaphyseal both-bone forearm fractures can be treated with closed reduction and casting without additional K-wire fixation. Nevertheless, a clinician should inform parents and patient about the high risk of fracture redisplacement (and therefore malunion), with risk for limited forearm rotation if left untreated. Weekly radiographic monitoring is essential. If redisplacement occurs, remanipulation and fixation with K-wires should be considered based on gender, age, and direction of angulation. Future research is required to establish the influence of (skeletal) age, gender, and the direction of malunion angulation on clinical outcome.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2022,Malunions occurred more often in the casting group than in the K-wire group: 19% (13 of 67) versus 7% (4 of 61) with an odds ratio of 0.22 for K-wiring (95% CI 0.06 to 0.80; p = 0.02).,"['Between January 2006 and December 2010, 128 patients were included in the original randomized controlled trial: 67 in the casting group and 61 in the K-wire group', 'At trauma, patients had a mean age of 9 ± 3 years and had mean angulations of the radius and ulna of 25° ± 14° and 23° ± 18°, respectively', 'Children with metaphyseal both-bone forearm fractures', 'children with a reduced metaphyseal both-bone forearm fracture', 'Between January 2014 and May 2016, 82% (105 of 128) of patients were included, with a mean follow-up of 6.8 ± 1.4 years: 54 in the casting group and 51 in the K-wire group']","['closed reduction and casting without additional K-wire fixation', 'above-elbow cast (casting group) or fixation with K-wires and an above-elbow cast (K-wire group']","['mean limitation in forearm rotation', 'Malunions', 'forearm rotation', 'limitation in forearm rotation', 'radiologic assessment, patient-reported outcome measures (QuickDASH and ABILHAND-kids), handgrip strength, and VAS score for cosmetic appearance', 'metaphyseal both-bone forearm fracture', 'radiographic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0041600', 'cui_str': 'Bone structure of ulna'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0223680', 'cui_str': 'Bone structure of forearm'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517503', 'cui_str': '1.4'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0223680', 'cui_str': 'Bone structure of forearm'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",128.0,0.0849227,Malunions occurred more often in the casting group than in the K-wire group: 19% (13 of 67) versus 7% (4 of 61) with an odds ratio of 0.22 for K-wiring (95% CI 0.06 to 0.80; p = 0.02).,"[{'ForeName': 'Leon W', 'Initials': 'LW', 'LastName': 'Diederix', 'Affiliation': 'Department of Orthopaedic Surgery, Elkerliek Hospital, Helmond, the Netherlands.'}, {'ForeName': 'Kasper C', 'Initials': 'KC', 'LastName': 'Roth', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Pim P', 'Initials': 'PP', 'LastName': 'Edomskis', 'Affiliation': 'Department of General Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Linde', 'Initials': 'L', 'LastName': 'Musters', 'Affiliation': 'Department of Orthopaedic Surgery, Noordwest Ziekenhuis Groep, Alkmaar, the Netherlands.'}, {'ForeName': 'Jan Hein', 'Initials': 'JH', 'LastName': 'Allema', 'Affiliation': 'Department of General Surgery, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Kraan', 'Affiliation': 'Department of Orthopaedic Surgery, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Reijman', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Joost W', 'Initials': 'JW', 'LastName': 'Colaris', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, Erasmus Medical Centre, Rotterdam, the Netherlands.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001980']
203,34544170,Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score.,"BACKGROUND


Bleeding risk is highly relevant for treatment decisions in cancer-associated thrombosis (CAT). Several risk scores exist, but have never been validated in patients with CAT and are not recommended for practice.
OBJECTIVES


To compare methods of estimating clinically relevant (major and clinically relevant nonmajor) bleeding risk in patients with CAT: (1) existing risk scores for bleeding in venous thromboembolism, (2) pragmatic classification based on cancer type, and (3) new prediction model.
METHODS


In a posthoc analysis of the Hokusai VTE Cancer study, a randomized trial comparing edoxaban with dalteparin for treatment of CAT, seven bleeding risk scores were externally validated (ACCP-VTE, HAS-BLED, Hokusai, Kuijer, Martinez, RIETE, and VTE-BLEED). The predictive performance of these scores was compared with a pragmatic classification based on cancer type (gastrointestinal; genitourinary; other) and a newly derived competing risk-adjusted prediction model based on clinical predictors for clinically relevant bleeding within 6 months after CAT diagnosis with nonbleeding-related mortality as the competing event (""CAT-BLEED"").
RESULTS


Data of 1,046 patients (149 events) were analyzed. Predictive performance of existing risk scores was poor to moderate (C-statistics: 0.50-0.57; poor calibration). Internal validation of the pragmatic classification and ""CAT-BLEED"" showed moderate performance (respective C-statistics: 0.61; 95% confidence interval [CI]: 0.56-0.66, and 0.63; 95% CI 0.58-0.68; good calibration).
CONCLUSION


Existing risk scores for bleeding perform poorly after CAT. Pragmatic classification based on cancer type provides marginally better estimates of clinically relevant bleeding risk. Further improvement may be achieved with ""CAT-BLEED,"" but this requires external validation in practice-based settings and with other DOACs and its clinical usefulness is yet to be demonstrated.",2022,"Internal validation of the pragmatic classification and ""CAT-BLEED"" showed moderate performance (respective C-statistics: 0.61; 95% confidence interval [CI]: 0.56-0.66, and 0.63; 95% CI 0.58-0.68; good calibration).
","['patients with CAT', 'Patients with Cancer-Associated Thrombosis', '1,046 patients (149 events) were analyzed', 'cancer-associated thrombosis (CAT']",['edoxaban with dalteparin'],"['CAT, seven bleeding risk scores', 'Predictive performance of existing risk scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0206461', 'cui_str': 'Dalteparin'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1046.0,0.165299,"Internal validation of the pragmatic classification and ""CAT-BLEED"" showed moderate performance (respective C-statistics: 0.61; 95% confidence interval [CI]: 0.56-0.66, and 0.63; 95% CI 0.58-0.68; good calibration).
","[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'de Winter', 'Affiliation': 'Department of Acute Internal Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Jannick A N', 'Initials': 'JAN', 'LastName': 'Dorresteijn', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery, University of Insubria, Varese, Italy.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Ay', 'Affiliation': 'Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Comprehensive Cancer Center Vienna, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beyer-Westendorf', 'Affiliation': 'Department of Hematology/Hemostasis, Dresden University Hospital ""Carl-Gustav Carus,"" Dresden, Germany.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Coppens', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Frederikus A', 'Initials': 'FA', 'LastName': 'Klok', 'Affiliation': 'Department of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Farès', 'Initials': 'F', 'LastName': 'Moustafa', 'Affiliation': 'Department of Emergency, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Riva', 'Affiliation': 'Department of Pathology, Faculty of Medicine and Surgery, University of Malta, Msida, Malta.'}, {'ForeName': 'Pedro C', 'Initials': 'PC', 'LastName': 'Ruiz Artacho', 'Affiliation': 'Department of Internal Medicine, Clínica Universidad de Navarra, Madrid, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanassche', 'Affiliation': 'Department of Cardiology, Leuven University Hospital, Leuven, Belgium.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Nijkeuter', 'Affiliation': 'Department of Acute Internal Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.'}]",Thrombosis and haemostasis,['10.1055/s-0041-1735251']
204,34560806,Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial.,"Intermediate-high-risk pulmonary embolism (PE) is characterized by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent hemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of hemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International THrOmbolysis (PEITHO)-3 study (ClinicalTrials.gov Identifier: NCT04430569) is a randomized, placebo-controlled, double-blind, multicenter, multinational trial with long-term follow-up. We will compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate-high-risk PE will also fulfill at least one clinical criterion of severity: systolic blood pressure ≤110 mm Hg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, hemodynamic decompensation, or PE recurrence within 30 days of randomization. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, hemodynamic decompensation, or stroke within 30 days; dyspnea, functional limitation, or RV dysfunction at 6 months and 2 years; and utilization of health care resources within 30 days and 2 years. The study is planned to enroll 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations.",2022,"In these patients, full-dose systemic thrombolysis reduced the risk of haemodynamic decompensation or death but increased the risk of life-threatening bleeding.","['acute intermediate high-risk pulmonary embolism', 'enrol 650 patients', 'Patients with intermediate high-risk PE will also fulfil at least one clinical criterion of severity: systolic blood pressure ≤ 110 mmHg, respiratory rate >20 breaths/min, or history of heart failure']",['placebo'],"['risk of life-threatening bleeding', 'fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death', 'risk of haemodynamic decompensation or death', 'PE-related death, haemodynamic decompensation, or stroke within 30 days; dyspnoea, functional limitation or RV dysfunction at 6 months and 2 years; and utilisation of healthcare resources', 'efficacy and safety', 'composite of all-cause death, haemodynamic decompensation or PE recurrence']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0242707', 'cui_str': 'Right ventricular dysfunction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.343354,"In these patients, full-dose systemic thrombolysis reduced the risk of haemodynamic decompensation or death but increased the risk of life-threatening bleeding.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sanchez', 'Affiliation': 'AP-HP, hôpital européen Georges-Pompidou, Service de Pneumologie et de Soins Intensifs, APHP.Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Charles-Nelson', 'Affiliation': 'AP-HP, hôpital européen Georges-Pompidou, Unité de Recherche Clinique, APHP.Centre, Paris, France.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery, University of Insubria, Varese, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barco', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Binder', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Chatellier', 'Affiliation': 'Université de Paris, Paris, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duerschmied', 'Affiliation': 'Department of Cardiology and Angiology I, University Heart Center Freiburg - Bad Krozingen, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Empen', 'Affiliation': 'Department of Internal Medicine, Städtisches Klinikum Dessau, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Internal Medicine Department, Hospital Garcia de Orta, Almada, Portugal.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'FCRIN INNOVTE, St-Etienne, France.'}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Dutch Thrombosis Network, Leiden, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jiménez', 'Affiliation': 'Department of Respiratory Diseases, Ramon y Cajal Hospital, Universidad de Alcalá (IRYCIS), CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Katsahian', 'Affiliation': 'Université de Paris, Paris, France.'}, {'ForeName': 'Matija', 'Initials': 'M', 'LastName': 'Kozak', 'Affiliation': 'Department of Vascular Diseases, University Medical Center, Ljubljana, Slovenia.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Lankeit', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meneveau', 'Affiliation': 'FCRIN INNOVTE, St-Etienne, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Pruszczyk', 'Affiliation': 'Department of Internal Medicine and Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Antoniu', 'Initials': 'A', 'LastName': 'Petris', 'Affiliation': 'Grigore T. Popa University of Medicine and Pharmacy Iasi, Cardiology Clinic, ""St. Spiridon"" County Clinical Emergency Hospital, Iasi, Romania.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Righini', 'Affiliation': 'Division of Angiology and Haemostasis, Geneva University Hospital, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rosenkranz', 'Affiliation': 'Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schellong', 'Affiliation': 'Department of Internal Medicine 2, Municipal Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Branislav', 'Initials': 'B', 'LastName': 'Stefanovic', 'Affiliation': 'Cardiology Clinic, Emergency Center, University Clinical Center of Serbia, School of Medicine University Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'Vascular Medicine and Haemostasis, Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'de Wit', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'AP-HP, Unité de Recherche Clinique St-Louis-Lariboisière, Université Denis Diderot, Paris, France.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zirlik', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Stavros V', 'Initials': 'SV', 'LastName': 'Konstantinides', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'AP-HP, hôpital européen Georges-Pompidou, Service de Pneumologie et de Soins Intensifs, APHP.Centre - Université de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thrombosis and haemostasis,['10.1055/a-1653-4699']
205,34530161,Deep Learning Computer-aided Polyp Detection Reduces Adenoma Miss Rate: A United States Multi-center Randomized Tandem Colonoscopy Study (CADeT-CS Trial).,"BACKGROUND & AIMS


Artificial intelligence-based computer-aided polyp detection (CADe) systems are intended to address the issue of missed polyps during colonoscopy. The effect of CADe during screening and surveillance colonoscopy has not previously been studied in a United States (U.S.) population.
METHODS


We conducted a prospective, multi-center, single-blind randomized tandem colonoscopy study to evaluate a deep-learning based CADe system (EndoScreener, Shanghai Wision AI, China). Patients were enrolled across 4 U.S. academic medical centers from 2019 through 2020. Patients presenting for colorectal cancer screening or surveillance were randomized to CADe colonoscopy first or high-definition white light (HDWL) colonoscopy first, followed immediately by the other procedure in tandem fashion by the same endoscopist. The primary outcome was adenoma miss rate (AMR), and secondary outcomes included sessile serrated lesion (SSL) miss rate and adenomas per colonoscopy (APC).
RESULTS


A total of 232 patients entered the study, with 116 patients randomized to undergo CADe colonoscopy first and 116 patients randomized to undergo HDWL colonoscopy first. After the exclusion of 9 patients, the study cohort included 223 patients. AMR was lower in the CADe-first group compared with the HDWL-first group (20.12% [34/169] vs 31.25% [45/144]; odds ratio [OR], 1.8048; 95% confidence interval [CI], 1.0780-3.0217; P = .0247). SSL miss rate was lower in the CADe-first group (7.14% [1/14]) vs the HDWL-first group (42.11% [8/19]; P = .0482). First-pass APC was higher in the CADe-first group (1.19 [standard deviation (SD), 2.03] vs 0.90 [SD, 1.55]; P = .0323). First-pass ADR was 50.44% in the CADe-first group and 43.64 % in the HDWL-first group (P = .3091).
CONCLUSION


In this U.S. multicenter tandem colonoscopy randomized controlled trial, we demonstrate a decrease in AMR and SSL miss rate and an increase in first-pass APC with the use of a CADe-system when compared with HDWL colonoscopy alone.",2022,"SSL miss rate was lower in the CADe-first group, 7.14% (1/14) versus the HDWL-first group, 42.11% (8/19) (P=0.0482).","['Patients presenting for colorectal cancer screening or surveillance', 'Patients were enrolled across four U.S. academic medical centers from 2019 through 2020', '2 32 patients entered the study, with 116 patients randomized to the AI-assisted colonoscopy first and 116 patients to HDWL colonoscopy first']","['CADe colonoscopy first or high-definition white light (HDWL) colonoscopy', 'deep-learning based CADe system (EndoScreener, Shanghai Wision AI, China', 'CADe']","['SSL miss rate', 'adenoma miss rate (AMR), and secondary outcomes included sessile serrated lesion (SSL) miss rate and adenomas per colonoscopy (APC', 'AMR', 'adenoma miss rate and SSL miss rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0563228', 'cui_str': 'White light'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]",116.0,0.0826247,"SSL miss rate was lower in the CADe-first group, 7.14% (1/14) versus the HDWL-first group, 42.11% (8/19) (P=0.0482).","[{'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Glissen Brown', 'Affiliation': 'Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts. Electronic address: jglissen@bidmc.harvard.edu.'}, {'ForeName': 'Nabil M', 'Initials': 'NM', 'LastName': 'Mansour', 'Affiliation': 'Section of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Maria Aguilera', 'Initials': 'MA', 'LastName': 'Chuchuca', 'Affiliation': 'Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Minchenberg', 'Affiliation': 'Department of Internal Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Chandnani', 'Affiliation': 'Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Institute of Natural Sciences, MOE-LSC, School of Mathematical Sciences and SJTU-Yale Joint Center for Biostatistics and Data Science, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Gross', 'Affiliation': 'Division of Gastroenterology and Hepatology, New York University Langone Health System, New York, New York.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Sengupta', 'Affiliation': 'Section of Gastroenterology, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Berzin', 'Affiliation': 'Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2021.09.009']
206,34696966,"Comparison of Ultrasound-Guided Pecto-intercostal Fascial Block and Transversus Thoracic Muscle Plane Block for Acute Poststernotomy Pain Management After Cardiac Surgery: A Prospective, Randomized, Double-Blind Pilot Study.","OBJECTIVE


The objective of the present study was to evaluate morphine consumption and pain scores 24 hours postoperatively to compare the effects of a bilateral pectointercostal fascial block (PIFB) with those of a transversus thoracic muscle plane block (TTMPB) on acute poststernotomy pain in cardiac surgery patients who have undergone median sternotomy.
DESIGN


Prospective, randomized, double-blinded.
SETTING


The operating room, intensive care unit, and patient ward at a university hospital.
PARTICIPANTS


Thirty-nine American Society of Anesthesiologists II-to-III patients aged 18- to-80 years, scheduled for elective cardiac surgery via median sternotomy.
INTERVENTIONS


Patients randomly were allocated to groups scheduled to receive bilateral ultrasound-guided PIFB or TTMPB.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was postoperative morphine use within the first 24 hours. Secondary outcomes were the numerical pain rating scale (NRS) scores at rest and during coughing, time of first analgesic demand from the patient-controlled analgesia (PCA) device, and rescue analgesia use. The nausea/vomiting scores, time to extubation, length of stays in intensive care and the hospital, patient satisfaction scores, and complications were also recorded. The first 24-hour morphine use did not significantly differ between the PIFB and TTMPB groups (mean ± standard deviation [95% CI], 13.89 ± 6.80 [10.83-16.95] mg/24 h and 15.08 ± 7.42 [11.83-18.33] mg/24 h, respectively, p = 0.608). No significant difference between the two groups in the NRS scores at rest and during coughing was observed; the groups had similar requirements for rescue analgesia in the first 24 hours (n [%], three [15.8] and seven [35], p = 0.273, respectively). The time from PCA to the first analgesia request was longer in the PIFB than in the TTMPB group (median [interquartile range], 660 [540-900] minutes, and 240 [161-525] minutes, respectively, p = 0.002).
CONCLUSIONS


PIFB and TTMPB showed similar effectiveness for morphine consumption within 24 hours postoperatively and in pain scores in cardiac surgery patients.",2022,"CONCLUSIONS


PIFB and TTMPB showed similar effectiveness for morphine consumption within 24 hours postoperatively and in pain scores in cardiac surgery patients.","['Thirty-nine American Society of Anesthesiologists II-to-III patients aged 18- to-80 years, scheduled for elective cardiac surgery via median sternotomy', 'Acute Poststernotomy Pain Management', 'The operating room, intensive care unit, and patient ward at a university hospital', 'cardiac surgery patients who have undergone median sternotomy', 'cardiac surgery patients']","['PIFB and TTMPB', 'TTMPB', 'transversus thoracic muscle plane block (TTMPB', 'bilateral pectointercostal fascial block (PIFB', 'Ultrasound-Guided Pectointercostal Fascial Block and Transversus Thoracic Muscle Plane Block', 'bilateral ultrasound-guided PIFB or TTMPB']","['rescue analgesia', 'numerical pain rating scale (NRS) scores at rest and during coughing, time of first analgesic demand from the patient-controlled analgesia (PCA) device, and rescue analgesia use', 'nausea/vomiting scores, time to extubation, length of\xa0stays in intensive care and the hospital, patient satisfaction scores, and complications', 'NRS scores at rest and during coughing', 'pain scores', 'postoperative morphine use within the first 24 hours', 'morphine consumption and pain scores']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0224337', 'cui_str': 'Skeletal muscle structure of thorax'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",39.0,0.409684,"CONCLUSIONS


PIFB and TTMPB showed similar effectiveness for morphine consumption within 24 hours postoperatively and in pain scores in cardiac surgery patients.","[{'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Kaya', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Dost', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey. Electronic address: burhandost@hotmail.com.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Dokmeci', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Semih Murat', 'Initials': 'SM', 'LastName': 'Yucel', 'Affiliation': 'Department of Cardiovascular Surgery, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Karakaya', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.09.041']
207,34595983,Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4-immunoglobulin G-seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial.,"BACKGROUND


Efficacy and safety of inebilizumab for treatment of neuromyelitis optica spectrum disorder in adults seropositive for aquaporin-4 (AQP4)-immunoglobulin (Ig) G were demonstrated in the 28-week randomized controlled period of the N-MOmentum study.
OBJECTIVE


To assess efficacy and safety of long-term inebilizumab treatment.
METHODS


Post hoc analysis was performed in 75 AQP4-IgG-seropositive participants receiving inebilizumab for ⩾4 years in the randomized controlled period and open-label extension of the N-MOmentum study.
RESULTS


Eighteen attacks occurred in 13 participants during inebilizumab treatment (annualized attack rate, 0.052 attacks/person-year). Twelve attacks occurred during the first year of treatment, and two each occurred in years 2-4. Disability scores remained stable throughout ⩾4 years of treatment. Inebilizumab was well tolerated, with two (2.7%) serious treatment-emergent adverse events related to inebilizumab and no deaths. Immunoglobulin G levels decreased over time; however, correlation between severe infections and low IgG levels could not be determined because of their small numbers.
CONCLUSION


These results from the N-MOmentum study continue to support use of inebilizumab for treatment of neuromyelitis optica spectrum disorder. Furthermore, the findings suggest that efficacy of inebilizumab may be enhanced after the first year of treatment, warranting additional long-term investigation.",2022,"Inebilizumab was well tolerated, with two (2.7%) serious treatment-emergent adverse events related to inebilizumab and no deaths.","['optica spectrum disorder', 'adults seropositive for aquaporin-4', 'neuromyelitis', '75 AQP4-IgG-seropositive participants receiving inebilizumab for ⩾4\u2009years in the randomized controlled period and open-label extension of the N-MOmentum study']","['AQP4)-immunoglobulin (Ig) G', 'aquaporin-4-immunoglobulin G-seropositive participants taking inebilizumab', 'Inebilizumab', 'inebilizumab']","['Immunoglobulin G levels', 'efficacy and safety', 'tolerated', 'Disability scores']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0292777', 'cui_str': 'Aquaporin-4'}, {'cui': 'C0027872', 'cui_str': 'Neuromyelitis'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0563597', 'cui_str': 'Momentum'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0292777', 'cui_str': 'Aquaporin-4'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",75.0,0.0450173,"Inebilizumab was well tolerated, with two (2.7%) serious treatment-emergent adverse events related to inebilizumab and no deaths.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rensel', 'Affiliation': 'Mellen Center for Multiple Sclerosis, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Zabeti', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Mealy', 'Affiliation': 'Horizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cimbora', 'Affiliation': 'Horizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).'}, {'ForeName': 'Dewei', 'Initials': 'D', 'LastName': 'She', 'Affiliation': 'Horizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).'}, {'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Drappa', 'Affiliation': 'Horizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Katz', 'Affiliation': 'Horizon Therapeutics plc, Deerfield, IL, USA; (known as Viela Bio at the time of study conduct).'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211047223']
208,34595963,Free From Falls education and exercise program for reducing falls in people with multiple sclerosis: A randomized controlled trial.,"BACKGROUND


People with multiple sclerosis (PwMS) fall frequently. Community-delivered exercise and education reduce falls in older adults, but their efficacy in multiple sclerosis (MS) is unknown.
OBJECTIVES


To evaluate the impact of the Free From Falls (FFF) group education and exercise program on falls in PwMS.
METHODS


This was a prospective, assessor-blinded, two-arm parallel randomized controlled trial. Ninety-six participants were randomized to FFF (eight weekly 2 hour sessions) or the control condition (a fall prevention brochure and informing their neurologist of their fall history). Participants counted falls prospectively from enrollment through 6 months following intervention. Effects on fall frequency were evaluated by the Bayesian analysis.
RESULTS


The modeled mean fall frequency pre-intervention was 1.2 falls/month in the FFF group (95% credible intervals (CIs) = 0.8-2.0) and 1.4 falls/month in the control group (95% CI = 0.9-2.1). Fall frequency decreased by 0.6 falls/month in both groups over time (nadir 4-6 months post-intervention: FFF 0.6 falls/month (95% CI = 0.4-0.9); control 0.8 falls/month (95% CI = 0.5-1.1)).
CONCLUSION


In-person group exercise and education are not superior to written education and neurologist-initiated interventions for preventing falls in PwMS.",2022,In-person group exercise and education are not superior to written education and neurologist-initiated interventions for preventing falls in PwMS.,"['Ninety-six participants', 'older adults', 'people with multiple sclerosis']","['Community-delivered exercise and education', 'FFF', 'Free From Falls (FFF) group education and exercise program', 'Free From Falls education and exercise program', 'control condition (a fall prevention brochure and informing their neurologist of their fall history']","['fall frequency', 'Fall frequency']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0019664', 'cui_str': 'History'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",96.0,0.0286868,In-person group exercise and education are not superior to written education and neurologist-initiated interventions for preventing falls in PwMS.,"[{'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Cameron', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Veterans Affairs Portland Health Care System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hildebrand', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Veterans Affairs Portland Health Care System, Portland, OR, USA.'}, {'ForeName': 'Cinda L', 'Initials': 'CL', 'LastName': 'Hugos', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Veterans Affairs Portland Health Care System, Portland, OR, USA.'}, {'ForeName': 'Grace I', 'Initials': 'GI', 'LastName': 'Judd', 'Affiliation': 'School of Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Garnett', 'Initials': 'G', 'LastName': 'McMillan', 'Affiliation': 'National Center for Rehabilitative Auditory Research, Veterans Affairs Portland Health Care System, Portland, OR, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211046898']
209,34645954,Electrocardiogram for heart rate evaluation during preterm resuscitation at birth: a randomized trial.,"BACKGROUND


Although electrocardiogram (ECG) can detect heart rate (HR) faster compared to pulse oximetry, it remains unknown if routine use of ECG for delivery room (DR) resuscitation reduces the time to stabilization in preterm infants.
METHODS


Neonates <31 weeks' gestation were randomized to either an ECG-displayed or an ECG-blinded HR assessment in the DR. HR, oxygen saturation, resuscitation interventions, and clinical outcomes were compared.
RESULTS


During the study period, 51 neonates were enrolled. The mean gestational age in both groups was 28 ± 2 weeks. The time to stabilization, defined as the time from birth to achieve HR ≥100 b.p.m., as well as oxygen saturation within goal range, was not different between the ECG-displayed and the ECG-blinded groups [360 (269, 435) vs 345 (240, 475) s, p = 1.00]. There was also no difference in the time to HR ≥100 b.p.m. [100 (75, 228) vs 138 (88, 220) s, p = 0.40] or duration of positive pressure ventilation (PPV) [345 (120, 558) vs 196 (150, 273) s, p = 0.36]. Clinical outcomes were also similar between groups.
CONCLUSIONS


Although feasible and safe, the use of ECG in the DR during preterm resuscitation did not reduce time to stabilization.
IMPACT


Although feasible and apparently safe, routine use of the ECG in the DR did not decrease time to HR >100 b.p.m., time to stabilization, or use of resuscitation interventions such as PPV for preterm infants <31 weeks' gestational age. This article adds to the limited randomized controlled trial evidence regarding the impact of routine use of ECG during preterm resuscitation on DR clinical outcomes. Such evidence is important when considering recommendations for routine use of the ECG in the DR worldwide as such a recommendation comes with a significant cost burden.",2022,"Clinical outcomes were also similar between groups.
","['preterm infants', '51 neonates were enrolled', ""preterm infants <31 weeks' gestational age"", 'preterm resuscitation at birth', ""Neonates <31 weeks' gestation""]","['electrocardiogram (ECG', 'ECG-displayed or an ECG-blinded HR assessment in the DR', 'ECG for delivery room (DR) resuscitation', 'Electrocardiogram']","['HR, oxygen saturation, resuscitation interventions, and clinical outcomes', 'duration of positive pressure ventilation', 'oxygen saturation']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]",51.0,0.152337,"Clinical outcomes were also similar between groups.
","[{'ForeName': 'Natalia V', 'Initials': 'NV', 'LastName': 'Abbey', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Mashruwala', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Weydig', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Steven Brown', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Ramon', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ibrahim', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Imran N', 'Initials': 'IN', 'LastName': 'Mir', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Myra H', 'Initials': 'MH', 'LastName': 'Wyckoff', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Kapadia', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA. vishal.kapadia@utsouthwestern.edu.'}]",Pediatric research,['10.1038/s41390-021-01731-z']
210,34650004,Telerehabilitation for chronic respiratory disease: a randomised controlled equivalence trial.,"RATIONALE


Pulmonary rehabilitation is an effective treatment for people with chronic respiratory disease but is delivered to <5% of eligible individuals. This study investigated whether home-based telerehabilitation was equivalent to centre-based pulmonary rehabilitation in people with chronic respiratory disease.
METHODS


A multicentre randomised controlled trial with assessor blinding, powered for equivalence was undertaken. Individuals with a chronic respiratory disease referred to pulmonary rehabilitation at four participating sites (one rural) were eligible and randomised using concealed allocation to pulmonary rehabilitation or telerehabilitation. Both programmes were two times per week for 8 weeks. The primary outcome was change in Chronic Respiratory Disease Questionnaire Dyspnoea (CRQ-D) domain at end-rehabilitation, with a prespecified equivalence margin of 2.5 points. Follow-up was at 12 months. Secondary outcomes included exercise capacity, health-related quality of life, symptoms, self-efficacy and psychological well-being.
RESULTS


142 participants were randomised to pulmonary rehabilitation or telerehabilitation with 96% and 97% included in the intention-to-treat analysis, respectively. There were no significant differences between groups for any outcome at either time point. Both groups achieved meaningful improvement in dyspnoea and exercise capacity at end-rehabilitation. However, we were unable to confirm equivalence of telerehabilitation for the primary outcome ΔCRQ-D at end-rehabilitation (mean difference (MD) (95% CI) -1 point (-3 to 1)), and inferiority of telerehabilitation could not be excluded at either time point (12-month follow-up: MD -1 point (95% CI -4 to 1)). At end-rehabilitation, telerehabilitation demonstrated equivalence for 6-minute walk distance (MD -6 m, 95% CI -26 to 15) with possibly superiority of telerehabilitation at 12 months (MD 14 m, 95% CI -10 to 38).
CONCLUSION


telerehabilitation may not be equivalent to centre-based pulmonary rehabilitation for all outcomes, but is safe and achieves clinically meaningful benefits. When centre-based pulmonary rehabilitation is not available, telerehabilitation may provide an alternative programme model.
TRIAL REGISTRATION NUMBER


ACtelerehabilitationN12616000360415.",2022,"At end-rehabilitation, telerehabilitation demonstrated equivalence for 6-minute walk distance (MD -6 m, 95% CI -26 to 15) with possibly superiority of telerehabilitation at 12 months (MD 14 m, 95% CI -10 to 38).
","['Individuals with a chronic respiratory disease referred to pulmonary rehabilitation at four participating sites (one rural', 'chronic respiratory disease', '142 participants', 'people with chronic respiratory disease']","['home-based telerehabilitation was equivalent to centre-based pulmonary rehabilitation', 'concealed allocation to pulmonary rehabilitation or telerehabilitation']","['6-minute walk distance', 'exercise capacity, health-related quality of life, symptoms, self-efficacy and psychological well-being', 'change in Chronic Respiratory Disease Questionnaire Dyspnoea (CRQ-D) domain at end-rehabilitation', 'dyspnoea and exercise capacity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",142.0,0.203887,"At end-rehabilitation, telerehabilitation demonstrated equivalence for 6-minute walk distance (MD -6 m, 95% CI -26 to 15) with possibly superiority of telerehabilitation at 12 months (MD 14 m, 95% CI -10 to 38).
","[{'ForeName': 'Narelle S', 'Initials': 'NS', 'LastName': 'Cox', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia narelle.cox@monash.edu.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Institute for Breathing and Sleep, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Mahal', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': 'School of Health Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wootton', 'Affiliation': 'Norwegian Centre for eHealth Research, University Hospital of North Norway, Tromso, Norway.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Hill', 'Affiliation': 'Physiotherapy, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zanaboni', 'Affiliation': 'Norwegian Centre for eHealth Research, University Hospital of North Norway, Tromso, Norway.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bondarenko', 'Affiliation': 'Physiotherapy, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Macdonald', 'Affiliation': 'Wimmera Health Care Group, Horsham, Victoria, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Barker', 'Affiliation': 'Physiotherapy, Western Health, Footscray, Victoria, Australia.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Crute', 'Affiliation': 'Wimmera Health Care Group, Horsham, Victoria, Australia.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Mellerick', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Wageck', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Boursinos', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Aroub', 'Initials': 'A', 'LastName': 'Lahham', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Nichols', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Czupryn', 'Affiliation': 'West Wimmera Health Service, Nhill, Victoria, Australia.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Corbett', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Handley', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Angela T', 'Initials': 'AT', 'LastName': 'Burge', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Holland', 'Affiliation': 'Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia.'}]",Thorax,['10.1136/thoraxjnl-2021-216934']
211,34619073,Increasing Acceptability and Outcome Expectancy for Internet-Based Cognitive Behavioral Therapy During the COVID-19 Pandemic.,"Background:   e-Health interventions for mental health have the potential to reduce burdens on health care systems, but large survey studies find low acceptability for these interventions. The COVID-19 pandemic may make attitudes toward e-health more malleable. The current study examined whether an intervention to improve attitudes toward Internet-based cognitive behavioral therapy (iCBT) has a greater impact during the COVID-19 pandemic than before the pandemic.   Materials and Methods:   Individuals ( N  = 662) recruited from a large university and surrounding community who participated in a study about the acceptability of iCBT in 2018 and 2019 were asked to participate in a follow-up survey. In the original study, participants were randomized to receive or not receive a rationale designed to increase acceptability of iCBT, and then they completed measures of acceptability and outcome expectancy for iCBT. Fifty-one participants enrolled in the follow-up study from May to July 2020. They received a treatment rationale for iCBT (or not) in keeping with randomization from the parent study and re-completed measures assessing the acceptability and outcome expectancy for iCBT.   Results:   Contrary to hypotheses, two-way analyses of covariance (ANCOVA's) demonstrated that there was no significant interaction between time point and rationale condition on acceptability or outcome expectancy for iCBT. There was a significant main effect of rationale condition on acceptability, such that participants who received a treatment rationale reported greater acceptability for iCBT. There were no significant main effects of time.   Conclusions:   A treatment rationale was effective in improving acceptability for iCBT in a general population sample, but not more so during the COVID-19 pandemic.",2022,"There was a significant main effect of rationale condition on acceptability, such that participants who received a treatment rationale reported greater acceptability for iCBT.","['Fifty-one participants enrolled in the follow-up study from May to July 2020', 'Individuals ( N \u2009=\u2009662) recruited from a large university and surrounding community who participated in a study about the acceptability of iCBT in 2018 and', 'mental health']","[':  e-Health interventions', 'Internet-based cognitive behavioral therapy (iCBT']",['acceptability of iCBT'],"[{'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",51.0,0.10495,"There was a significant main effect of rationale condition on acceptability, such that participants who received a treatment rationale reported greater acceptability for iCBT.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Molloy', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Page L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, Georgia, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2021.0393']
212,34619066,The Effects of Text Messages for Promoting Physical Activities in Prediabetes: A Randomized Controlled Trial.,"Objective:  To test the effects of text messages for promoting physical activities in people with prediabetes.  Methods:  This randomized controlled trial was performed in participants with prediabetes. Participants were recruited from a primary care unit. Allocation to the study groups used a stratified block randomization. All participants received physical activity education at baseline. The intervention group additionally received supportive text messages by using mobile phone text messages. Participants were assessed at baseline at 8 and 12 weeks. The primary outcome measure was physical activity energy. Secondary outcomes included weight, body mass index, waist circumstance, and blood pressure.  Results:  All participants were included in the analyses ( n  = 324; control:  n  = 162; intervention:  n  = 162). Mean physical activity energy was significantly increased in those who received text messages at 8 weeks, increasing 1,590.73 Metabolic Equivalent of Tasks (METs)/min/week (95% confidence interval [CI]: 837.72, 2343.75) in the intervention group and 407.39 METs/min/weeks (95% CI: -267.59, 1082.36) in the control group with an adjusted mean difference of -1,183 METs/min/weeks (95% CI: -2190.11, -176.58,  p  = 0.02). Over the 12 weeks follow-up period, mean physical activity energy did not differ statistically by group. Mixed-model repeated-measures analysis of the total physical energy revealed no significant differences, with an adjusted mean difference 273.3 METs/min/week (95% CI: -530.64, 1077.21,  p  = 0.513). However, moderate physical energy was significantly increased to 256.40 METs/min/week (95% CI: 17.20, 495.63,  p  = 0.040).  Conclusion:  Text messaging significant in physical activity at the 8-week. But, text messaging no significant in physical activity at 12-week. Further research is needed to identify optimal times to send messages to people with prediabetes. Thai Clinical Trials Registry (TCTR), number: TCTR20200624008.",2022,"Mean physical activity energy was significantly increased in those who received text messages at 8 weeks, increasing 1,590.73 Metabolic Equivalent of Tasks (METs)/min/week","['Prediabetes', 'people with prediabetes', 'Participants were recruited from a primary care unit', 'participants with prediabetes', 'All participants were included in the analyses ( n \u2009=\u2009324; control:  n \u2009=\u2009162; intervention:  n \u2009=\u2009162']","['physical activity education', 'supportive text messages by using mobile phone text messages', 'Text Messages', 'text messages']","['physical activity energy', 'physical activity', 'Mean physical activity energy', 'weight, body mass index, waist circumstance, and blood pressure', 'moderate physical energy', 'mean physical activity energy']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.209931,"Mean physical activity energy was significantly increased in those who received text messages at 8 weeks, increasing 1,590.73 Metabolic Equivalent of Tasks (METs)/min/week","[{'ForeName': 'Prawit', 'Initials': 'P', 'LastName': 'Bootwong', 'Affiliation': 'Health System Science Unit, Faculty of Medicine, Mahasarakham University, Muang, Mahasarakham, Thailand.'}, {'ForeName': 'Nirun', 'Initials': 'N', 'LastName': 'Intarut', 'Affiliation': 'PhD student in Health Sciences, Faculty of Medicine, Mahasarakham University, Muang, Mahasarakham, Thailand.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2021.0303']
213,34621011,Enzalutamide versus bicalutamide in patients with nonmetastatic castration-resistant prostate cancer: a prespecified subgroup analysis of the STRIVE trial.,"BACKGROUND


In the phase 2, randomized, double-blind STRIVE trial, enzalutamide significantly reduced the risk of prostate cancer progression or death versus bicalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) and nonmetastatic CRPC (nmCRPC). The objective of this protocol-specified subgroup analysis of STRIVE was to investigate the benefit of enzalutamide versus bicalutamide specifically in patients with nmCRPC.
METHODS


Patients (N = 139) were stratified by disease stage and randomized to enzalutamide 160 mg/day plus androgen deprivation therapy (ADT; n = 70) or bicalutamide 50 mg/day plus ADT (n = 69).
RESULTS


Baseline characteristics of patients with nmCRPC were comparable between groups. At a median of 17 months follow-up, enzalutamide reduced the risk of progression or death by 76% versus bicalutamide in patients with nmCRPC (hazard ratio [HR], 0.24; 95% CI 0.14-0.42). Enzalutamide reduced risk of prostate-specific antigen progression by 82% versus bicalutamide in patients with nmCRPC (HR, 0.18; 95% CI 0.10-0.34). The most frequently reported adverse events by patients receiving enzalutamide were fatigue (36.2%), hot flush (20.3%), decreased appetite (17.4%), dizziness (17.4%), and nausea (17.4%).
CONCLUSIONS


This STRIVE subgroup analysis of patients with nmCRPC illustrates the benefit of enzalutamide in reducing the risk of progression or death versus bicalutamide in patients with nmCRPC.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT01664923.",2022,"At a median of 17 months follow-up, enzalutamide reduced the risk of progression or death by 76% versus bicalutamide in patients with nmCRPC (hazard ratio [HR], 0.24; 95% CI 0.14-0.42).","['patients with nonmetastatic castration-resistant prostate cancer', 'patients with nmCRPC', 'Patients (N\u2009=\u2009139', 'patients with metastatic castration-resistant prostate cancer (mCRPC) and nonmetastatic CRPC (nmCRPC']","['bicalutamide', 'enzalutamide 160\u2009mg/day plus androgen deprivation therapy (ADT; n\u2009=\u200970) or bicalutamide 50\u2009mg/day plus ADT', 'Enzalutamide', 'Enzalutamide versus bicalutamide', 'enzalutamide versus bicalutamide', 'enzalutamide']","['decreased appetite', 'fatigue', 'risk of prostate-specific antigen progression', 'risk of prostate cancer progression or death', 'risk of progression or death', 'adverse events', 'dizziness', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0285590', 'cui_str': 'bicalutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0984137', 'cui_str': 'bicalutamide 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.602777,"At a median of 17 months follow-up, enzalutamide reduced the risk of progression or death by 76% versus bicalutamide in patients with nmCRPC (hazard ratio [HR], 0.24; 95% CI 0.14-0.42).","[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Penson', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA. david.penson@vumc.org.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC, USA.'}, {'ForeName': 'Raoul S', 'Initials': 'RS', 'LastName': 'Concepcion', 'Affiliation': 'The Comprehensive Prostate Center, Nashville, TN, USA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Olsson', 'Affiliation': 'Accumed Research Associates, Garden City, NY, USA.'}, {'ForeName': 'Lawrence I', 'Initials': 'LI', 'LastName': 'Karsh', 'Affiliation': 'The Urology Center of Colorado, Denver, CO, USA.'}, {'ForeName': 'Curtis J', 'Initials': 'CJ', 'LastName': 'Dunshee', 'Affiliation': 'Urological Associates of Southern Arizona, Tucson, AZ, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Duggan', 'Affiliation': 'Global Product Development, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Global Product Development, Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'Biostatistics, Astellas Pharma, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Gabriel P', 'Initials': 'GP', 'LastName': 'Haas', 'Affiliation': 'Global Development, Astellas Pharma, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Department of Medicine, Division of Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00465-7']
214,34629379,"Comparison of a preservative-free nonsteroidal anti-inflammatory drug and preservative-free corticosteroid after uneventful cataract surgery: multicenter, randomized, evaluator-blinded clinical trial.","PURPOSE


To compare the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) and steroidal eyedrops for inflammation management after cataract surgery using slitlamp indicators.
SETTING


11 eye centers in South Korea.
DESIGN


Randomized prospective multicenter study with a blinded evaluator.
METHOD


In 125 (250 eyes) patients who underwent cataract surgery, bromfenac sodium hydrate 0.1% (NSAID group) was applied twice a day in 1 eye, whereas the other eye was treated with fluorometholone 0.1% (steroid group), 4 times a day for 4 weeks postoperatively. The primary efficacy outcome was the presence of anterior chamber cells and flare at 1 week postoperatively. Anterior chamber cells and flare at 4 to 8 weeks, corrected distance visual acuity, central corneal thickness, conjunctival hyperemia, dry eye parameters, foveal thickness, and ocular and visual discomfort were evaluated as secondary outcomes.
RESULTS


At week 1, residual anterior chamber inflammation was not statistically significantly different between the groups (-1.03 ± 1.27 vs -0.95 ± 1.24, P = .4850). However, the NSAID group recovered from conjunctival hyperemia more rapidly than the steroid group (0.30 ± 0.52 vs 0.44 ± 0.81, P = .0144 at week 1). The increase in central corneal thickness in the NSAID group was less than that in the steroid group 1 week postoperatively (7.87 ± 22.46 vs 29.47 ± 46.60 μm, P < .0001). The change in foveal thickness in the NSAID group was significantly less than that in the steroid group (18.11 ± 68.19 vs 22.25 ± 42.37 μm, P = .0002). Lower levels of postoperative ocular and visual discomfort were reported in the NSAID group than in the steroid group under treatment.
CONCLUSIONS


Preservative-free bromfenac was as effective as preservative-free fluorometholone eyedrops in anterior chamber inflammation control and showed better signs and symptoms after cataract surgery.",2022,"The increase in central corneal thickness in the NSAID group was less than that in the steroid group 1 week after surgery (7.87±22.46vs.29.47±46.60μm, p<0.0001).","['Eleven eye centers in South Korea', '125 patients undergoing cataract surgery', 'after uncomplicated cataract Surgery']","['nonsteroidal anti-inflammatory drugs (NSAIDs) and steroidal eye drops', 'preservative-free non-steroidal anti-Inflammatory drug and preservative-free corticosteroid', 'fluorometholone']","['presence of anterior chamber cells and flare', 'corrected visual acuity, central corneal thickness, conjunctival hyperemia, dry eye parameters, foveal thickness, and ocular and visual discomfort', 'residual anterior chamber inflammation', 'central corneal thickness', 'conjunctival hyperemia', 'change in foveal thickness', 'postoperative ocular and visual discomfort']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0016351', 'cui_str': 'Fluorometholone'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0423282', 'cui_str': 'Anterior chamber cells'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042818', 'cui_str': 'Visual discomfort'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",125.0,0.0625566,"The increase in central corneal thickness in the NSAID group was less than that in the steroid group 1 week after surgery (7.87±22.46vs.29.47±46.60μm, p<0.0001).","[{'ForeName': 'Seonjoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ""From the Department of Ophthalmology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea (S.J. Kim, Chung, H.S. Kim); Department of Ophthalmology, Konyang University College of Medicine, Daejeon, South Korea (Ko); Department of Ophthalmology, Chosun University College of Medicine, Gwangju, South Korea (Koh); Department of Ophthalmology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, South Korea (E.C. Kim); Department of Ophthalmology, School of Medicine, Kyungpook National University, Daegu, South Korea (H.K. Kim); Department of Ophthalmology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea (Shin); Department of Ophthalmology, Korea University College of Medicine, Seoul, South Korea (Song); Department of Ophthalmology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea (D.H. Lee); Department of Ophthalmology, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, South Korea (J.E. Lee); Department of Ophthalmology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea (H.K. Lee).""}, {'ForeName': 'Byung-Yi', 'Initials': 'BY', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Koh', 'Affiliation': ''}, {'ForeName': 'Eun Chul', 'Initials': 'EC', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hong Kyun', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Shin', 'Affiliation': ''}, {'ForeName': 'Jong-Suk', 'Initials': 'JS', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Do Hyung', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hyung Keun', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'So-Hyang', 'Initials': 'SH', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Hyun Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000841']
215,34644419,Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial.,"OBJECTIVES


The aim of this study was to assess whether the use of topical pharyngeal anesthesia improves endoscopist- and patient-reported tolerance and satisfaction, the total dose of propofol used and the rate of adverse effects associated with this procedure.
METHODS


This double-blind randomized clinical trial was conducted in patients undergoing elective oesophagogastroduodenoscopy, who met the inclusion criteria. Patients were randomly assigned to receive five squirts of lidocaine 10% spray (50 mg, n = 268) or placebo (n = 271) 3 min before starting the procedure or sedation. The main outcome measures were patient- and endoscopist-reported tolerance, and additionally, satisfaction with the procedure, adverse events and supplementary propofol used.
RESULTS


In the lidocaine group, it was twice (odds ratio [OR] 2.136, 95% confidence interval [CI] 1.228-3.715) or three times (OR 3.311, 95% CI 1.623-6.757) more likely that the endoscopist rated the procedure as well tolerated and easy to intubate than as well tolerated but the patient difficult to intubate or as poorly tolerated, respectively. Further, in these patients, less propofol was used (80 vs. 100 mg, P = 0.001). Controls were more likely to cough during the intubation (OR 2.172, 95% CI 1.378-3.423) and the procedure (OR 1.989, 95% CI 1.325-2.984), as well as more likely to retch (OR 3.582, 95% CI 1.667-7.7).
CONCLUSIONS


Topical lidocaine may improve the procedure as rated by the endoscopist, as well as reduce the requirement for propofol and rate of adverse events such as retching and coughing. No adverse events associated with lidocaine administration were observed. ClinicalTrials registration no. NCT02733471.",2022,"Controls were more likely to cough during the intubation (OR=2.172; 95% CI, 1.378-3.423) and the procedure (OR=1.989; 95% CI, 1.325-2.984), as well as more likely to retch (OR=3.582; 95% CI, 1.667-7.7).
","['patients undergoing elective oesophagogastroduodenoscopy, who met the inclusion criteria']","['lidocaine', 'Topical lidocaine', 'lidocaine 10% spray', 'propofol', 'Pharyngeal Lidocaine Anesthesia For Esophagogastroduodenoscopy', 'placebo', 'topical pharyngeal anesthesia']","['tolerated and easy to intubate than as well-tolerated', 'patient- and endoscopist-reported tolerance, and additionally, satisfaction with the procedure, adverse events and supplementary propofol used']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",,0.415437,"Controls were more likely to cough during the intubation (OR=2.172; 95% CI, 1.378-3.423) and the procedure (OR=1.989; 95% CI, 1.325-2.984), as well as more likely to retch (OR=3.582; 95% CI, 1.667-7.7).
","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Martín-Marcos', 'Affiliation': 'Bioaraba, Nursing and Health Care Research Group, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Fernández-Morte', 'Affiliation': 'Bioaraba, Nursing and Health Care Research Group, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Balsategui-Martín', 'Affiliation': 'Bioaraba, Nursing and Health Care Research Group, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ortiz-Cantero', 'Affiliation': 'Bioaraba, Nursing and Health Care Research Group, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bermúdez-Ampudia', 'Affiliation': 'Osakidetza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'López-Picado', 'Affiliation': 'Clinical Research and Clinical Trials Unit, Hospital Clínico San Carlos, IdISSC, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Pérez-Vaquero', 'Affiliation': 'Osakidetza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Salvador-Pérez', 'Affiliation': 'Osakidetza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Estíbaliz', 'Initials': 'E', 'LastName': 'Cristóbal-Domínguez', 'Affiliation': 'Bioaraba, Nursing and Health Care Research Group, Vitoria-Gasteiz, Spain.'}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.14168']
216,34595695,¡Yo no Estoy Loca! A Behavioral Health Telenovela Style Entertainment Education Video: Increasing Mental Health Literacy Among Latinas.,"Lack of knowledge and negative attitudes towards mental health is linked to low utilization of services among Latinxs. Entertainment-education videos have been effective at increasing literacy and reducing stigma across different health domains but Latinxs have not been a focus of research. We developed an E-E video aimed at reducing stigma and increasing mental health literacy. Focus groups (N = 28) and expert consultants (N = 2) were used to aid in the development of the video. After the video was developed, we conducted a randomized control trial (RCT) in which Latina participants (N = 111) were assigned to view the video or receive an informational brochure. Results indicated that participants in the video intervention condition experienced statistically significant increases in mental health literacy as compared to the participants in the flyer condition and that both the video and the flyer contributed to shifts in stigma.",2022,Results indicated that participants in the video intervention condition experienced statistically significant increases in mental health literacy as compared to the participants in the flyer condition and that both the video and the flyer contributed to shifts in stigma.,"['Latina participants (N\u2009=\u2009111', 'Increasing Mental Health Literacy Among Latinas']","['Behavioral Health Telenovela Style Entertainment Education Video', 'video or receive an informational brochure', 'Entertainment-education videos']",['mental health literacy'],"[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]",111.0,0.0213756,Results indicated that participants in the video intervention condition experienced statistically significant increases in mental health literacy as compared to the participants in the flyer condition and that both the video and the flyer contributed to shifts in stigma.,"[{'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Psychology, University of Nevada, Reno, MS 0296, Reno, NV, 89509, USA.'}, {'ForeName': 'Lorraine T', 'Initials': 'LT', 'LastName': 'Benuto', 'Affiliation': 'Department of Psychology, University of Nevada, Reno, MS 0296, Reno, NV, 89509, USA. dr.benuto@gmail.com.'}]",Community mental health journal,['10.1007/s10597-021-00892-9']
217,34605319,"Rapid and sustained B-cell depletion with subcutaneous ofatumumab in relapsing multiple sclerosis: APLIOS, a randomized phase-2 study.","BACKGROUND


Ofatumumab, the first fully human anti-CD20 monoclonal antibody, is approved in several countries for relapsing multiple sclerosis (RMS).
OBJECTIVE


To demonstrate the bioequivalence of ofatumumab administered by an autoinjector versus a pre-filled syringe (PFS) and to explore the effect of ofatumumab on B-cell depletion.
METHODS


APLIOS (NCT03560739) is a 12-week, open-label, parallel-group, phase-2 study in patients with RMS receiving subcutaneous ofatumumab 20 mg every 4 weeks (q4w) (from Week 4, after initial doses on Days 1, 7, and 14). Patients were randomized 10:10:1:1 to autoinjector or PFS in the abdomen, or autoinjector or PFS in the thigh, respectively. Bioequivalence was determined by area under the curve (AUC τ ) and maximum plasma concentration ( C max ) for Weeks 8-12. B-cell depletion and safety/tolerability were assessed.
RESULTS


A total of 256 patients contributed to the bioequivalence analyses (autoinjector-abdomen,  n  = 128; PFS-abdomen,  n  = 128). Abdominal ofatumumab pharmacokinetic exposure was bioequivalent for autoinjector and PFS (geometric mean AUC τ , 487.7 vs 474.1 h × µg/mL (ratio 1.03);  C max , 1.409 vs 1.409 µg/mL (ratio 1.00)). B-cell counts (median cells/µL) depleted rapidly in all groups from 214.0 (baseline) to 2.0 (Day 14). Ofatumumab was well tolerated.
CONCLUSION


Ofatumumab 20 mg q4w self-administered subcutaneously via autoinjector is bioequivalent to PFS administration and provides rapid B-cell depletion.",2022,"Abdominal ofatumumab pharmacokinetic exposure was bioequivalent for autoinjector and PFS (geometric mean AUC τ , 487.7 vs 474.1 h × µg/mL (ratio 1.03);  C max , 1.409 vs 1.409 µg/mL (ratio 1.00)).","['relapsing multiple sclerosis', '256 patients contributed to the bioequivalence analyses (autoinjector-abdomen,  n  = 128; PFS-abdomen,  n  = 128']","['autoinjector or PFS', 'RMS receiving subcutaneous ofatumumab', 'autoinjector versus a pre-filled syringe (PFS', 'Ofatumumab']","['area under the curve (AUC τ ) and maximum plasma concentration ( C max ', 'tolerated', 'B-cell depletion and safety/tolerability']","[{'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",256.0,0.169242,"Abdominal ofatumumab pharmacokinetic exposure was bioequivalent for autoinjector and PFS (geometric mean AUC τ , 487.7 vs 474.1 h × µg/mL (ratio 1.03);  C max , 1.409 vs 1.409 µg/mL (ratio 1.00)).","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'A Bar-Or Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce Street - 3 Gates Building, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Alvarez', 'Affiliation': 'Department of Neurology, Rocky Mountain MS Center, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Davydovskaya', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Silvia R', 'Initials': 'SR', 'LastName': 'Delgado', 'Affiliation': 'MS Center and Department of Neurology, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Evgeniy P', 'Initials': 'EP', 'LastName': 'Evdoshenko', 'Affiliation': 'St Petersburg Center for Multiple Sclerosis and Other Autoimmune Diseases, St Petersburg, Russian Federation.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Giedraitiene', 'Affiliation': 'Clinic of Neurology and Neurosurgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Gross-Paju', 'Affiliation': 'West-Tallinn Central Hospital, Tallinn, Estonia/Institute of Health Care Technology, TalTech, Tallinn, Estonia.'}, {'ForeName': 'Sulev', 'Initials': 'S', 'LastName': 'Haldre', 'Affiliation': 'Department of Neurology and Neurosurgery, University of Tartu, Tartu, Estonia/Neurology Clinic, Tartu University Hospital, Tartu, Estonia.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Herrman', 'Affiliation': 'JWM Neurology, Indianapolis, IN, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Izquierdo', 'Affiliation': 'Multiple Sclerosis Unit, Hospital Vithas NISA Sevilla, Sevilla, Spain.'}, {'ForeName': 'Guntis', 'Initials': 'G', 'LastName': 'Karelis', 'Affiliation': 'Neurology and Neurosurgery Department, Riga East University Hospital and Riga Stradins University, Riga, Latvia.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Leutmezer', 'Affiliation': 'Department of Neurology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Mares', 'Affiliation': 'Department of Neurology, Pardubice Regional Hospital, Pardubice, Czech Republic.'}, {'ForeName': 'Jose E', 'Initials': 'JE', 'LastName': 'Meca-Lallana', 'Affiliation': 'Multiple Sclerosis CSUR, Department of Neurology, Virgen de la Arrixaca Clinical University Hospital-IMIB-Arrixaca, Murcia, Spain/Clinical Neuroimmunology and Multiple Sclerosis Cathedra, Universidad Católica San Antonio (UCAM), Murcia, Spain.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickeviciene', 'Affiliation': 'Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Nicholas', 'Affiliation': 'OhioHealth Riverside Methodist Hospital, Columbus, OH, USA.'}, {'ForeName': 'Derrick S', 'Initials': 'DS', 'LastName': 'Robertson', 'Affiliation': 'Multiple Sclerosis Division, Department of Neurology, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Denis V', 'Initials': 'DV', 'LastName': 'Sazonov', 'Affiliation': 'Department of Clinical Trials FSBIH SDMC of FMBA of Russia, Novosibirsk, Russian Federation.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Sharlin', 'Affiliation': 'Sharlin Health and Neurology, Ozark, MO, USA.'}, {'ForeName': 'Bharathy', 'Initials': 'B', 'LastName': 'Sundaram', 'Affiliation': 'Texas Institute for Neurological Disorders, Sherman, TX, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Totolyan', 'Affiliation': 'Department of Neurology, First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vachova', 'Affiliation': 'Department of Neurology, Teplice Hospital, Teplice, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Valis', 'Affiliation': 'Department of Neurology, Faculty of Medicine in Hradec Králové, Charles University in Prague and University Hospital Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bagger', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Dieter A', 'Initials': 'DA', 'LastName': 'Häring', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Ludwig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Willi', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zalesak', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Merschhemke', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants PA, Round Rock, TX, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211044479']
218,34609521,Internal fixation versus hip arthroplasty in patients with nondisplaced femoral neck fractures: short-term results from a geriatric trauma registry.,"PURPOSE


To determine whether internal fixation (IF) or hip arthroplasty (HA) is associated with superior outcomes in geriatric nondisplaced femoral neck fracture (FNF) patients.
METHODS


Data from the Registry for Geriatric Trauma of the German Trauma Society (ATR-DGU) were analyzed (IF Group 449 and HA Group 1278 patients). In-hospital care and a 120-day postoperative follow-up were conducted. Primary outcomes, including mobility, residential status, reoperation rate, and a generic health status measure (EQ-5D score), and the secondary outcome of mortality were compared between groups. Multivariable analyses were performed to assess independent treatment group associations (odds ratios, ORs) with the primary and secondary end points.
RESULTS


Patients in the HA group were older (83 vs. 81 years, p < 0.001) and scored higher on the Identification of Seniors at Risk screening (3 vs. 2, p < 0.001). We observed no differences in residential status, reoperation rate, EQ-5D score, or mortality between groups. After adjusting for key covariates, including prefracture ambulatory capacity, the mobility of patients in the HA group was more frequently impaired at the 120-day follow-up (OR 2.28, 95% confidence interval = 1.11-4.74).
CONCLUSION


Treatment with HA compared to treatment with IF led to a more than twofold increase in the adjusted odds of impaired ambulation at the short-term follow-up, while no significant associations with residential status, reoperation rate, EQ-5D index score, or mortality were observed. Thus, IF for geriatric nondisplaced FNFs was associated with superior mobility 120 days after surgery. However, before definitive treatment recommendations can be made, prospective, randomized, long-term studies must be performed to confirm our findings.",2022,"RESULTS


Patients in the HA group were older (83 vs. 81 years, p < 0.001) and scored higher on the Identification of Seniors at Risk screening (3 vs. 2, p < 0.001).","['Data from the Registry for Geriatric Trauma of the German Trauma Society (ATR-DGU) were analyzed (IF Group 449 and HA Group 1278 patients', 'geriatric nondisplaced femoral neck fracture (FNF) patients', 'patients with nondisplaced femoral neck fractures']","['Internal fixation versus hip arthroplasty', 'internal fixation (IF) or hip arthroplasty (HA']","['residential status, reoperation rate, EQ-5D index score, or mortality', 'residential status, reoperation rate, EQ-5D score, or mortality', 'prefracture ambulatory capacity', 'mobility, residential status, reoperation rate, and a generic health status measure (EQ-5D score), and the secondary outcome of mortality', 'Identification of Seniors at Risk screening']","[{'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3711837', 'cui_str': 'ATR protein, human'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",,0.149072,"RESULTS


Patients in the HA group were older (83 vs. 81 years, p < 0.001) and scored higher on the Identification of Seniors at Risk screening (3 vs. 2, p < 0.001).","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Laubach', 'Affiliation': 'Department of Orthopaedics, Trauma and Reconstructive Surgery, RWTH Aachen University Hospital, Pauwelsstraße 30, 52074, Aachen, Germany. mlaubach@ukaachen.de.'}, {'ForeName': 'Felix M', 'Initials': 'FM', 'LastName': 'Bläsius', 'Affiliation': 'Department of Orthopaedics, Trauma and Reconstructive Surgery, RWTH Aachen University Hospital, Pauwelsstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Volland', 'Affiliation': 'AUC-Academy for Trauma Surgery (AUC), Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Knobe', 'Affiliation': 'Department of Orthopedic and Trauma Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Weber', 'Affiliation': 'Department of Orthopaedics, Trauma and Reconstructive Surgery, RWTH Aachen University Hospital, Pauwelsstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hildebrand', 'Affiliation': 'Department of Orthopaedics, Trauma and Reconstructive Surgery, RWTH Aachen University Hospital, Pauwelsstraße 30, 52074, Aachen, Germany.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Pishnamaz', 'Affiliation': 'Department of Orthopaedics, Trauma and Reconstructive Surgery, RWTH Aachen University Hospital, Pauwelsstraße 30, 52074, Aachen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of trauma and emergency surgery : official publication of the European Trauma Society,['10.1007/s00068-021-01801-1']
219,34626579,Cost-Effectiveness of a Group vs Individually Delivered Exercise Program in Community-Dwelling Persons Aged ≥70 Years.,"OBJECTIVES


Interventions aimed at reducing falls and physical inactivity could alleviate the economic burden attributable to these factors. The study aimed to analyze the cost-effectiveness of a group-delivered version of the Lifestyle-integrated Functional Exercise Program compared with an individually delivered program version.
DESIGN


An economic evaluation conducted alongside the LiFE-is-LiFE randomized non-inferiority trial.
INTERVENTIONS


Group and individually delivered version of a program consisting of strength and balance exercises integrated into everyday activities to prevent falls.
SETTING AND PARTICIPANTS


309 community-dwelling older adults (aged ≥70 years) at risk of falling recruited around Heidelberg and Stuttgart (Germany).
METHODS


Cost-effectiveness of the group program was assessed over 6 months using different effect measures [quality-adjusted life years (QALYs, EQ-5D-5L), physical activity (mean number of steps/day), and falls] and cost perspectives (societal and payer's). Incremental cost-effectiveness ratios were determined, and cost-effectiveness acceptability curves were constructed.
RESULTS


From a societal perspective, mean costs, the number of falls, and the number of steps/day were somewhat higher in the group program, whereas QALYs were almost identical between the 2 interventions. From the payer's perspective, the incremental cost-effectiveness ratio for the group compared to the individual program were €56,733 per QALY and €4755 per fall prevented. Based on the cost-effectiveness acceptability curves, the cost-effectiveness of the group program had to be rated as uncertain for both effect measures and perspectives. In contrast, it demonstrated cost-effectiveness for increasing physical activity at willingness-to-pay values per additional 1000 steps/day of €1600 (societal perspective) or €600 (payer's perspective).
CONCLUSIONS AND IMPLICATIONS


Compared to the individual program, the group program might be cost-effective for increasing physical activity in older adults but was unlikely to be cost-effective with regard to QALY or for preventing falls. The cost-effectiveness should be evaluated long-term and compared to a regular care group.",2022,"From a societal perspective, mean costs and QALYs were almost identical between the 2 interventions, and the number of falls was somewhat higher in the group program.","['aged ≥70\xa0years) at risk of falling recruited around Heidelberg and Stuttgart (Germany', '309 community-dwelling older adults', 'Community-Dwelling Persons Aged ≥70\xa0Years', 'older adults']","['Group vs Individually Delivered Exercise Program', 'Lifestyle-integrated Functional Exercise Program', 'Group and individually delivered version of a program consisting of strength and balance exercises integrated into everyday activities to prevent falls']","['Cost-Effectiveness', 'incremental cost-effectiveness ratio', 'cost-effectiveness acceptability curves', 'Incremental cost-effectiveness ratios', ""quality-adjusted life years (QALYs, EQ-5D-5L), physical activity (mean number of steps/day), and falls] and cost perspectives (societal and payer's"", 'cost-effectiveness', 'mean costs and QALYs', 'number of falls']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.00625329,"From a societal perspective, mean costs and QALYs were almost identical between the 2 interventions, and the number of falls was somewhat higher in the group program.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gottschalk', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg Center for Health Economics, Hamburg, Germany. Electronic address: s.gottschalk@uke.de.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg Center for Health Economics, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwenk', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Nerz', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Klenk', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert Bosch Hospital, Stuttgart, Germany; Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany; IB University of Applied Health and Social Sciences, Study Centre Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Carl-Philipp', 'Initials': 'CP', 'LastName': 'Jansen', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany; Department of Clinical Gerontology and Geriatric Rehabilitation, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Dams', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg Center for Health Economics, Hamburg, Germany.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.08.041']
220,34626578,Implementation and Use of Point-of-Care C-Reactive Protein Testing in Nursing Homes.,"OBJECTIVES


This study evaluated logistics, process data, and barriers/facilitators for the implementation and use of C-reactive protein point-of-care testing (CRP POCT) for suspected lower respiratory tract infections (LRTIs) in nursing home (NH) residents.
DESIGN


This process evaluation was performed alongside a cluster randomized, controlled trial (UPCARE study) to evaluate the effect of CRP POCT on antibiotic prescribing for suspected LRTIs in NH residents.
SETTING AND PARTICIPANTS


Eleven NHs in the Netherlands.
METHODS


Data sources for process data regarding intervention quality included a questionnaire among NH staff, logs, reports, and CRP POCT-analyzer records. Barriers and facilitators for implementation were assessed in focus group interviews with physicians and nurses from 3 NHs.
RESULTS


Correct patient selection for CRP POCT and generally continued CRP POCT use indicated good fidelity. The initial training and training of new employees seemed to fit the need, but some POCT-user group sizes had increased over time, which could have impeded frequent use. Users were generally satisfied with CRP POCT and perceived its use feasible and relevant. Facilitators for implementation were initial commitment and active initiation, followed by continued attention and enthusiasm for building routine practice and trust. Short lines of communication between staff, short distance to the POCT-analyzer, 24/7 coverage of staff, and a clear task division facilitated continued attention and routine practice.
CONCLUSIONS AND IMPLICATIONS


This process evaluation showed sufficient quality of providing CRP POCT in Dutch NHs. We processed findings of intervention quality and implementation knowledge into key recommendations for CRP POCT implementation in this setting. Future research could focus on CRP POCT use in countries with different organization of care in NHs.",2022,"This study evaluated logistics, process data, and barriers/facilitators for the implementation and use of C-reactive protein point-of-care testing (CRP POCT) for suspected lower respiratory tract infections (LRTIs) in nursing home (NH) residents.
","['Eleven NHs in the Netherlands', 'Nursing Homes', 'NH residents', 'suspected lower respiratory tract infections (LRTIs) in nursing home (NH) residents']","['Point-of-Care C-Reactive Protein Testing', 'C-reactive protein point-of-care testing (CRP POCT', 'CRP POCT']",[],"[{'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]",[],,0.0138611,"This study evaluated logistics, process data, and barriers/facilitators for the implementation and use of C-reactive protein point-of-care testing (CRP POCT) for suspected lower respiratory tract infections (LRTIs) in nursing home (NH) residents.
","[{'ForeName': 'Tjarda M', 'Initials': 'TM', 'LastName': 'Boere', 'Affiliation': 'Department of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam UMC, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Rogier M', 'Initials': 'RM', 'LastName': 'Hopstaken', 'Affiliation': 'Star-shl Diagnostic Centers, Etten-Leur, the Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Faculty of Behavioral and Movement Sciences, Amsterdam Movement Sciences Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Franҫois G', 'Initials': 'FG', 'LastName': 'Schellevis', 'Affiliation': 'Department of General Practice, Amsterdam Public Health Research Institute, Amsterdam UMC, VU University Medical Center, Amsterdam, the Netherlands; NIVEL (Netherlands Institute for Health Services Research (NIVEL), Utrecht, the Netherlands.'}, {'ForeName': 'Theo J M', 'Initials': 'TJM', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands; National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.'}, {'ForeName': 'Cees M P M', 'Initials': 'CMPM', 'LastName': 'Hertogh', 'Affiliation': 'Department of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam UMC, VU University Medical Center, Amsterdam, the Netherlands; National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'van Buul', 'Affiliation': 'Department of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam UMC, VU University Medical Center, Amsterdam, the Netherlands. Electronic address: l.vanbuul@amsterdamumc.nl.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.09.010']
221,34654603,"The effect of piezocision vs no piezocision on maxillary extraction space closure: A split-mouth, randomized controlled clinical trial.","INTRODUCTION


The aim of this 2-arm-parallel, split-mouth trial was to investigate the effects of piezocision compared with no piezocision on maxillary canine distalization and to evaluate patient perceptions on the surgical procedure.
METHODS


Twenty-two participants requiring extractions of maxillary first premolars were recruited from the Department of Orthodontics (Sydney Dental Hospital) waiting list. After leveling and alignment, a minimum of 3 mm space was required for canine retraction. Piezocision cuts distal to the canines were 4 mm long and 3 mm deep into the buccal cortical plate. The canine retraction was initiated on both sides immediately after surgery, with coil springs delivering 150 g of force per side. Random assignment of piezocision or control intervention on the patient's right side was performed (www.randomisation.com) for the random number generation, and allocation concealment was accomplished with opaque, sealed envelopes. Patients were assessed every 6 weeks for coil activation and alginate impressions over 18 weeks. The primary outcome was the amount of tooth movement in mm. Secondary outcomes were canine rotation, anchorage loss measured on scanned dental models, and patient pain levels and perception on piezocision using visual analog scale questionnaires. Blinding was feasible for the dental model measurements.
RESULTS


Twenty patients completed the trial. The treatment × time interaction showed no statistically or clinically significant differences in maxillary extraction space closure (b = -0.02; 95% confidence interval [CI], -0.29 to 0.25; P = 0.89) canine rotation (b = -1.45; 95% CI, -4 to 1.09; P = 0.26) and anchorage loss (b = -0.02; 95% CI, -0.38 to 0.34; P = 0.92). All patients except for one had minimal pain associated with the piezocision surgery but found the procedure tolerable and would recommend it. No harm occurred during the trial.
CONCLUSIONS


Piezocision-assisted maxillary canine distalization was similar to distalization with conventional orthodontics with patients tolerating the procedure.",2022,The treatment × time interaction showed no statistically or clinically significant differences in maxillary extraction space closure (,"['Twenty patients completed the trial', 'Twenty-two participants requiring extractions of maxillary first premolars were recruited from the Department of Orthodontics (Sydney Dental Hospital) waiting list']","['piezocision vs no piezocision', 'Piezocision-assisted maxillary canine distalization', 'piezocision or control intervention', 'no piezocision', 'piezocision']","['canine rotation', 'maxillary extraction space closure', 'anchorage loss', 'maxillary extraction space closure ', 'canine rotation, anchorage loss measured on scanned dental models, and patient pain levels and perception on piezocision using visual analog scale questionnaires', 'amount of tooth movement in mm', 'minimal pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C3164440', 'cui_str': 'Dental hospital'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0011381', 'cui_str': 'Dental Model'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",22.0,0.371889,The treatment × time interaction showed no statistically or clinically significant differences in maxillary extraction space closure (,"[{'ForeName': 'Vanessa Margaret', 'Initials': 'VM', 'LastName': 'Hawkins', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, and Department of Orthodontics, Sydney Dental Hospital, Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Papadopoulou', 'Affiliation': 'Division of Orthodontics, University Clinics of Medicine and Dentistry, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, and Department of Orthodontics, Sydney Dental Hospital, Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pandis', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, School of Dentistry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Oyku', 'Initials': 'O', 'LastName': 'Dalci', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, and Department of Orthodontics, Sydney Dental Hospital, Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Mehmet Ali', 'Initials': 'MA', 'LastName': 'Darendeliler', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, and Department of Orthodontics, Sydney Dental Hospital, Sydney Local Health District, Sydney, Australia. Electronic address: ali.darendeliler@sydney.edu.au.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2021.06.015']
222,34687636,"Safety, tolerability, and activity of mesenchymal stem cells versus placebo in multiple sclerosis (MESEMS): a phase 2, randomised, double-blind crossover trial.","BACKGROUND


Mesenchymal stem cells (MSCs), also known as mesenchymal stromal cells, have been proposed as a promising therapeutic option for people with multiple sclerosis on the basis of their immunomodulatory and neuroprotective properties. The MEsenchymal StEm cells for Multiple Sclerosis (MESEMS) study was devised to evaluate the safety, tolerability, and activity of autologous MSCs derived from bone marrow and infused intravenously in patients with active multiple sclerosis.
METHODS


MESEMS is a randomised phase 2 trial done at 15 sites in nine countries. Patients (aged 18-50 years) with active relapsing-remitting or progressive multiple sclerosis were included if they had a disease duration of 2-15 years since onset of multiple sclerosis and an Expanded Disability Status Scale score of 2·5-6·5. Patients were randomly assigned (1:1), according to a crossover design, to receive a single intravenous dose of autologous bone marrow-derived MSCs followed by placebo at week 24, or to receive placebo followed by autologous MSCs at week 24, with a follow-up visit at week 48. Primary objectives were to test safety and activity of MSC treatment. The primary safety endpoint was to assess the number and severity of adverse events within each treatment arm. The primary efficacy endpoint was the number of gadolinium-enhancing lesions (GELs) counted over week 4, 12, and 24 compared between treatment groups. The primary efficacy endpoint was assessed in the full analyis set, after all participants completed the week 24 visit. Efficacy endpoints were evaluated using a predefined statistical testing procedure. Safety was monitored throughout the study by recording vital signs and adverse events at each visit.
FINDINGS


From July 16, 2012, until July 31, 2019, 144 patients were randomly assigned to first receive early intravenous infusion of autologous bone marrow-derived MSCs (n=69) or placebo (n=75). MSC treatment did not meet the primary endpoint of efficacy on the total number of GELs accumulated from baseline to week 24 (rate ratio [RR] 0·94, 95% CI 0·58-1·50; p=0·78). 213 adverse events were recorded, similarly distributed between groups (93 cases recorded in 35 [51%] of 69 patients treated first with MSCs vs 120 cases in 42 [56%] of 75 patients infused first with placebo). The most frequent adverse events reported were infection and infestations, with a total of 54 (25%) of 213 adverse events (18 [19%] of 93 in the early-MSC group and 36 [30%] of 120 in the delayed-MSC group). Nine serious adverse events were reported in seven patients treated with placebo versus none in the MSC group. All serious adverse events were considered to be unrelated to the treatment infusion. No deaths were reported during the study.
INTERPRETATION


Bone marrow-derived MSC treatment was safe and well tolerated but did not show an effect on GELs, an MRI surrogate marker of acute inflammation, in patients with active forms of multiple sclerosis, at week 24. Thus, this study does not support the use of bone marrow-derived MSCs to treat active multiple sclerosis. Further studies should address the effect of MSCs on parameters related to tissue repair.
FUNDING


Fondazione Italiana Sclerosi Multipla (FISM), the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), and the Multiple Sclerosis International Federation (MSIF) for centralised activities. Individual trials participating in the MESEMS network are funded by the following agencies: FISM and Compagnia di San Paolo (Italy); The Danish Multiple Sclerosis Society, The Toyota Foundation, and Danish Blood Donors' Research Foundation (Denmark); the Spanish Health Research Institute Carlos 3 and the Andalusian Public Foundation Progreso y Salud (Spain); the Royan Institute for Stem Cell Biology and Technology (Iran); the Spinal Cord Injury and Tissue Regeneration Centre Salzburg, Paracelsus Medical University, and Salzburg (Austria); the Fondation pour l'aide à la recherche sur la sclérose en plaques (ARSEP), French Muscular Dystrophy Association (AFM)-Telethon (France); the UK Multiple Sclerosis Society and the UK Stem Cell Foundation (UK); and the Multiple Sclerosis Society of Canada and The Multiple Sclerosis Scientific Research Foundation and Research Manitoba (Canada).",2021,"The most frequent adverse events reported were infection and infestations, with a total of 54 (25%) of 213 adverse events (18 [19%] of 93 in the early-MSC group and 36 [30%] of 120 in the delayed-MSC group).","['15 sites in nine countries', 'patients with active multiple sclerosis', 'multiple sclerosis (MESEMS', 'From July 16, 2012, until July 31, 2019, 144 patients', 'people with multiple sclerosis', 'San Paolo (Italy', 'Patients (aged 18-50 years) with active relapsing-remitting or progressive multiple sclerosis were included if they had a disease duration of 2-15 years since onset of multiple sclerosis and an Expanded Disability Status Scale score of 2·5-6·5']","['placebo followed by autologous MSCs', 'MSC', 'autologous bone marrow-derived MSCs followed by placebo', 'placebo', 'autologous bone marrow-derived MSCs (n=69) or placebo']","['number of gadolinium-enhancing lesions (GELs', 'number and severity of adverse events', 'safety and activity of MSC treatment', 'total number of GELs', 'Safety, tolerability, and activity of mesenchymal stem cells', 'safety, tolerability, and activity of autologous MSCs', 'Safety', 'Nine serious adverse events', '213 adverse events']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]",144.0,0.127089,"The most frequent adverse events reported were infection and infestations, with a total of 54 (25%) of 213 adverse events (18 [19%] of 93 in the early-MSC group and 36 [30%] of 120 in the delayed-MSC group).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Uccelli', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, and Center of Excellence for Biomedical Research, University of Genoa, Genoa, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy. Electronic address: auccelli@neurologia.unige.it.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Laroni', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, and Center of Excellence for Biomedical Research, University of Genoa, Genoa, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Rehiana', 'Initials': 'R', 'LastName': 'Ali', 'Affiliation': 'Department of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Mario Alberto', 'Initials': 'MA', 'LastName': 'Battaglia', 'Affiliation': 'Department of Life Sciences, University of Siena, Italy; Italian Multiple Sclerosis Foundation, Genoa, Italy.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Blinkenberg', 'Affiliation': 'Danish Multiple Sclerosis Centre, Department of Neurology, University of Copenhagen and Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Brundin', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, and Division of Neurology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Clanet', 'Affiliation': 'Department of Neurology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Fernandez', 'Affiliation': 'Department of Neurology, Instituto de Investigación Biomédica de Málaga, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marriot', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Muraro', 'Affiliation': 'Department of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Seyed Massood', 'Initials': 'SM', 'LastName': 'Nabavi', 'Affiliation': 'Department of Brain and Cognitive Sciences, Cell Science Research Centre and Regenerative Medicine Department, Royan Institute for Stem Cell Biology and Technology, Academic Center for Education, Culture and Research, Tehran, Iran.'}, {'ForeName': 'Roberto S', 'Initials': 'RS', 'LastName': 'Oliveri', 'Affiliation': 'Cell Therapy Unit, Department of Clinical Immunology, University of Copenhagen and Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Radue', 'Affiliation': 'Medical Image Analysis Centre and Department of Biomedical Engineering, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ramo Tello', 'Affiliation': 'Multiple Sclerosis Unit, Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schiavetti', 'Affiliation': 'Department of Health Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Sellner', 'Affiliation': 'Department of Neurology, Christian Doppler Medical Centre, Paracelsus Medical University, Salzburg, Austria; Department of Neurology, Landesklinikum Mistelbach-Gänserndorf, Mistelbach, Austria.'}, {'ForeName': 'Per Soelberg', 'Initials': 'PS', 'LastName': 'Sorensen', 'Affiliation': 'Danish Multiple Sclerosis Centre, Department of Neurology, University of Copenhagen and Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'Department of Health Sciences, University of Genoa, Genoa, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Jens Thomas', 'Initials': 'JT', 'LastName': 'Wuerfel', 'Affiliation': 'Medical Image Analysis Centre and Department of Biomedical Engineering, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, ON, Canada; The Ottawa Hospital Research Institute, Ottawa, ON, Canada. Electronic address: mfreedman@toh.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(21)00301-X']
223,34686942,Randomized control trial evaluating the use of a shared decision-making aid for older ventral hernia patients in the Geriatric Assessment and Medical Preoperative Screening (GrAMPS) Program.,"PURPOSE


Shared decision making (SDM) is ideally suited to abdominal wall surgery in older adults given the breadth of decision making required by the hernia surgeon and the impact on quality of life (QOL) by various treatment options. Given the paucity of literature surrounding SDM in hernia patients, the feasibility of a novel, formalized SDM aid/tool was evaluated in a pilot randomized trial.
METHODS


Patients 60 years or older with a diagnosed ventral hernia were prospectively randomized at an academic hernia center. In the experimental arm, a novel SDM tool, based on the SHARE Approach, guided the consultation. Previously validated SDM assessments and patient's hernia knowledge retention was measured.
RESULTS


Eighteen (18) patients were randomized (9 control and 9 experimental). Cohorts were well matched in age (p = 0.51), comorbidities (Charlson Comorbidity Score: p = 0.43) and frailty (mFI-11: p = 0.19; Risk Analysis Index: p = 0.33). Consultation time was 11 min longer in the experimental cohort (p < 0.01). There was a trend towards better Decisional Conflict Scores in the experimental group (p = 0.25) and the experimental cohort had improved post-visit retained hernia knowledge (p < 0.01). All patients in the experimental arm (100%) enjoyed working through the SDM aid/tool and felt it was a worthwhile exercise.
CONCLUSION


Incorporating a formalized SDM tool into a busy hernia surgical practice is feasible and well received by patients. In addition, early results suggest it improves retention of basic hernia knowledge and may reduce patient's decisional conflict. Next steps include condensing the SDM tool to enhance efficiency within the clinic and beginning a large, randomized control trial.",2022,There was a trend towards better Decisional Conflict Scores in the experimental group (p = 0.25) and the experimental cohort had improved post-visit retained hernia knowledge (p < 0.01).,"['hernia patients', 'Patients 60\xa0years or older with a diagnosed ventral hernia', 'older adults', 'Eighteen (18) patients', 'older ventral hernia patients in the Geriatric Assessment and Medical Preoperative Screening (GrAMPS) Program']",['academic hernia center'],"['post-visit retained hernia knowledge', ""SDM assessments and patient's hernia knowledge retention"", 'Decisional Conflict Scores', 'Consultation time', 'retention of basic hernia knowledge']","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",,0.0479509,There was a trend towards better Decisional Conflict Scores in the experimental group (p = 0.25) and the experimental cohort had improved post-visit retained hernia knowledge (p < 0.01).,"[{'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Kushner', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8109, Saint Louis, MO, 63110, USA. B.kushner@wustl.edu.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Holden', 'Affiliation': 'Department of Medicine, Division of Geriatrics and Nutritional Science, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8109, Saint Louis, MO, 63110, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8109, Saint Louis, MO, 63110, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sehnert', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8109, Saint Louis, MO, 63110, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Majumder', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8109, Saint Louis, MO, 63110, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Blatnik', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8109, Saint Louis, MO, 63110, USA.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Holden', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8109, Saint Louis, MO, 63110, USA.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-021-02524-3']
224,34702123,Cost-utility of dapagliflozin plus standard treatment compared to standard treatment for the management of heart failure with reduced ejection fraction in Colombia.,"INTRODUCTION


The DAPA-HF study has shown that dapagliflozin added to standard treatment reduced the risks of worsening of heart failure or cardiovascular death compared to placebo.
OBJECTIVES


To evaluate the cost- utility of dapagliflozin in combination with standard treatment compared to standard treatment alone for the treatment of heart failure with reduced ejection fraction from the perspective of the Colombian health system.
METHODS


A Markov model using information from the DAPA-HF study was adapted to the Colombian setting. Health states considered symptom score, and transient health states were included to assess the incidence of consultations and hospitalizations for heart failure. The time horizon was 5 years and a 5% discount rate was applied. The costs were expressed in US dollars of 2020 (1 USD =$3,693.36 COP).
RESULTS


The incremental cost-effectiveness ratio (ICER) of the intervention compared to standard treatment was USD $5,946 per quality adjusted life year gained. The ICER remained below the cost-effectiveness threshold in sub-group analyses. 97% of sensitivity analysis simulations showed an ICER below the cost-effectiveness threshold.
CONCLUSION


From the perspective of the analysis, the addition of dapagliflozin to standard treatment is a cost-effective option in patients with heart failure with reduced ejection fraction in Colombia.",2022,The ICER remained below the cost-effectiveness threshold in sub-group analyses.,"['heart failure with reduced ejection fraction from the perspective of the Colombian health system', 'patients with heart failure with reduced ejection fraction in Colombia', 'heart failure with reduced ejection fraction in Colombia']","['dapagliflozin', 'dapagliflozin plus standard treatment']","['incremental cost-effectiveness ratio (ICER', 'risks of worsening of heart failure or cardiovascular death']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0683689,The ICER remained below the cost-effectiveness threshold in sub-group analyses.,"[{'ForeName': 'Yaneth', 'Initials': 'Y', 'LastName': 'Gil-Rojas', 'Affiliation': 'Department of Economic Studies, Neuroeconomix, Bogota, Colombia.'}, {'ForeName': 'Pieralessandro', 'Initials': 'P', 'LastName': 'Lasalvia', 'Affiliation': 'Department of Economic Studies, Neuroeconomix, Bogota, Colombia.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García', 'Affiliation': 'Cardiology Unit, San Ignacio University Hospital, Pontificia Universidad Javeriana, Bogotá, Colombia.'}]",Expert review of pharmacoeconomics & outcomes research,['10.1080/14737167.2022.1997595']
225,34709497,Evaluation of adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis based on a health survey: sub-analysis of a phase 3 study.,"OBJECTIVE


The equivalence of the biosimilar HS016 to adalimumab (Humira) for the treatment of active ankylosing spondylitis (AS) patients has been previously validated. The aim was to compare the efficacy of HS016 and adalimumab in stratified subgroups at different time points using Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) and short form 36 (SF-36) questionnaires.
METHODS


We carried out a multicenter, randomized, double-blind, parallel, positive control, phase 3 trial of patients with active AS. They were selected randomly to be subcutaneously administered 40 mg HS016 or adalimumab every 2 weeks for a total treatment period of 24 weeks in a 2:1 ratio. A health surveys were used to assess mental and physical improvements of patients as well as other factors.
RESULTS


HAQ-S revealed that changes in scores from baseline in both groups were time dependent until 14 weeks and that during the first 4 weeks of treatment the changes declined rapidly. The SF-36 health survey revealed that both HS016 and adalimumab produced rapid beneficial effects against AS during the first 2 weeks of therapy, which gradually declined between 2 and 12 weeks and flattened out after 12 weeks until 24 weeks.
CONCLUSION


This trial demonstrated that both HS016 and adalimumab produced rapid improvements in symptoms during the first 2 weeks of treatment. These findings suggest that HS016 is an alternative economical treatment for Chinese AS patients producing a rapid amelioration of symptoms, aiding them to recover their lifestyle satisfaction.
TRIAL REGISTRATION


http://www.chictr.org.cn/enindex.aspx , ChiCTR1900022520, retrospectively registered. Key points • HS016 and adalimumab produced rapid AS symptom improvements during the first 2 weeks followed by a slowdown of improvements until week 4 with afterwards few improvements evaluated by HAQ-S • The improvements according to the short form of the 36 (SF-36) questionnaires revealed similar trends as for HAQ-S • There was no significant difference in HAQ-S and SF-36 scores between HS016 and adalimumab.",2022,The improvements according to the short form of the 36 (SF-36) questionnaires revealed similar trends as for HAQ-S •,"['Chinese AS patients', 'stratified subgroups at different time points using Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) and short form 36 (SF-36) questionnaires', 'active ankylosing spondylitis (AS) patients', 'patients with active AS', 'Chinese patients with active ankylosing spondylitis']","['HS016 or adalimumab', 'HS016', 'adalimumab biosimilar candidate (HS016', 'adalimumab (Humira', 'HS016 and adalimumab']","['HAQ-S •', 'HAQ-S and SF-36 scores']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0949691', 'cui_str': 'Disorder of joint of spine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1171255', 'cui_str': 'Humira'}]","[{'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0949691', 'cui_str': 'Disorder of joint of spine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.16368,The improvements according to the short form of the 36 (SF-36) questionnaires revealed similar trends as for HAQ-S •,"[{'ForeName': 'Jinmei', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science and Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Mengtao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science and Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Rheumatology and Immunology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Dongbao', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Lindi', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Rheumatology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Cibo', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Xiumei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Xiangyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Rheumatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Tianwang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Zhuzhou Central Hospital, Zhuzhou, China.'}, {'ForeName': 'Dongyi', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Anbin', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Rheumatology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science and Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China. zengxfpumc@163.com.'}]",Clinical rheumatology,['10.1007/s10067-021-05943-w']
226,34716179,Implementation of a youth violence prevention programme in primary care.,"BACKGROUND AND OBJECTIVES


Youth violence is an alarming public health problem, yet, violence screening and interventions are not systematically offered in primary care (PC). This paper describes data from a pilot effectiveness-implementation trial of an efficacious youth violence prevention programme (SafERteens).
METHODS


The study was conducted in two PC clinics: a university-affiliated satellite clinic and a community health centre. In phase 1, we obtained stakeholder feedback to customise the SafERteens package and enrolled a comparison group of adolescents (age 14-18) seeking care in two clinics. In phase 2, clinical staff delivered the SafERteens-PC intervention with adolescents, which is a single, behavioural health therapy session delivered one-on-one from clinic providers to youth patients, followed by text message (TM) reminders. In phase 3, we assessed planned maintenance. All participants reported past-year violent behaviour at intake and completed a 3-month follow-up assessment.
RESULTS


Based on stakeholder interviews (n=13), we created a web-based SafERteens-PC programme package, including a three-item past-year violence screen, 30 min motivational interviewing-based brief intervention delivery tool, training videos and 2 months of TM boosters. We enrolled a comparison group (n=49) first, then an intervention group (n=61). Intervention delivery characteristics varied by clinic, including completion of intervention (75.9%; 62.5%), modality (100% delivered via telehealth; 60% via telehealth/40% in-person) and enrolment in TMs (81.8%; 55.0%); 91.8% completed the follow-up. Using an intention-to-treat approach, the intervention group showed significantly greater reductions in severe peer aggression (p<0.05), anxiety (p<0.05) and substance use consequences (p<0.05) relative to the comparison group. Participant and staff feedback were positive and identified challenges to long-term implementation, such as lack of availability of reimbursement for youth violence prevention.
CONCLUSIONS


If these challenges could be addressed, routine provision of behavioural health services for violence prevention in PC could have high impact on health outcomes for adolescents.",2022,"Using an intention-to-treat approach, the intervention group showed significantly greater reductions in severe peer aggression (p<0.05), anxiety (p<0.05) and substance use consequences (p<0.05) relative to the comparison group.","['adolescents (age 14-18) seeking care in two clinics', 'two PC clinics: a university-affiliated satellite clinic and a community health centre', 'primary care', 'adolescents', 'Youth violence']","['created a web-based SafERteens-PC programme package, including a three-item past-year violence screen, 30\u2009min motivational interviewing-based brief intervention delivery tool, training videos and 2\u2009months of TM boosters', 'youth violence prevention programme']","['severe peer aggression (p<0.05), anxiety (p<0.05) and substance use consequences']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}]",,0.0258747,"Using an intention-to-treat approach, the intervention group showed significantly greater reductions in severe peer aggression (p<0.05), anxiety (p<0.05) and substance use consequences (p<0.05) relative to the comparison group.","[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Roche', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, Michigan, USA jroche@med.umich.edu.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Philyaw-Kotov', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Sigel', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Andria B', 'Initials': 'AB', 'LastName': 'Eisman', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Family Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Carter', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, Michigan, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2021-044293']
227,34605016,"""Suction Tube Uterine Tamponade"" for treatment of refractory postpartum hemorrhage: Internal feasibility and acceptability pilot of a randomized clinical trial.","OBJECTIVE


To assess feasibility and acceptability of a novel, low-cost ""Suction Tube Uterine Tamponade"" (STUT) treatment for refractory postpartum hemorrhage (PPH).
METHODS


We allocated patients with refractory PPH by randomly ordered envelopes to STUT or routine uterine balloon tamponade (UBT, Ellavi free-flow system) in 10 hospitals in South Africa. In the STUT group, a 24FG Levin stomach tube was inserted into the uterine cavity and vacuum created with a vacuum pump or manual vacuum aspiration syringe.
RESULTS


For this internal pilot study, 12 participants were allocated to STUT and 12 to UBT. Insertion failed in one of each group and was recorded as difficult in 3/10 STUT and 4/9 UBT insertions respectively (five missing data). There were two laparotomies and one intensive care unit admission in the UBT group. Pain during STUT insertion was graded as none/mild in 9/10 and severe in 1/10. The experience of the STUT procedure was graded as fine in 4/11 and ""uncomfortable but acceptable"" in 7/11.
CONCLUSION


STUT is feasible and acceptable, justifying continuation of our trial. These data will also inform a large World Health Organization trial to test effectiveness of uterine tamponade methods. The numbers are too small to support any clinical recommendation.",2022,Insertion failed in one of each group and was recorded as difficult in 3/10 STUT and 4/9,"['refractory postpartum hemorrhage (PPH', 'refractory postpartum hemorrhage', '12 participants were allocated to STUT and 12 to UBT']","['vacuum pump or manual vacuum aspiration syringe', 'STUT or routine uterine balloon tamponade (UBT, Ellavi free-flow system', 'Suction Tube Uterine Tamponade', ""novel, low-cost 'Suction Tube Uterine Tamponade' (STUT""]",['Pain'],"[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0042223', 'cui_str': 'Suction Curettage'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C2936501', 'cui_str': 'Uterine Balloon Tamponade'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0179788', 'cui_str': 'Suction catheter'}, {'cui': 'C0404136', 'cui_str': 'Uterine pack procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",12.0,0.24336,Insertion failed in one of each group and was recorded as difficult in 3/10 STUT and 4/9,"[{'ForeName': 'Sylvia N', 'Initials': 'SN', 'LastName': 'Cebekhulu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Department of Health, Bloemfontein, Bongani Regional Hospital, University of the Free State, Hartbeespoort, South Africa.'}, {'ForeName': 'Hazmath', 'Initials': 'H', 'LastName': 'Abdul', 'Affiliation': 'Department of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Batting', 'Affiliation': 'Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand, Walter Sisulu, and Fort Hare, East London, South Africa.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Chauke', 'Affiliation': 'Department of Obstetrics and Gynaecology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand, Witwatersrand, South Africa.'}, {'ForeName': 'Fuziwe', 'Initials': 'F', 'LastName': 'Dlakavu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Steve Biko Academic Hospital, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Fawcus', 'Affiliation': 'Department Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Logie', 'Initials': 'L', 'LastName': 'Govender', 'Affiliation': 'Department of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Busiwe', 'Initials': 'B', 'LastName': 'Majeke', 'Affiliation': 'Department of Obstetrics and Gynaecology at Cecilia Makiwane Hospital, Walter Sisulu University, East London, South Africa.'}, {'ForeName': 'Xolani', 'Initials': 'X', 'LastName': 'Mbongozi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Nelson Mandela Academic Hospital, Walter Sisulu University, Mthatha, South Africa.'}, {'ForeName': 'Mandisa', 'Initials': 'M', 'LastName': 'Singata-Madliki', 'Affiliation': 'Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand, Walter Sisulu, and Fort Hare, East London, South Africa.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Middleton', 'Affiliation': 'Department of Obstetrics and Gynaecology, Frere Hospital and Walter Sisulu University, East London, South Africa.'}, {'ForeName': 'Philiswa', 'Initials': 'P', 'LastName': 'Mlandu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Chris Hani Baragwaneth Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Poovangela', 'Initials': 'P', 'LastName': 'Naidoo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Chris Hani Baragwaneth Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sanele', 'Initials': 'S', 'LastName': 'Ndaba', 'Affiliation': 'Department of Obstetrics and Gynaecology Kalafong Hospital, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Soma-Pillay', 'Affiliation': 'UP/SAMRC Research Centre for Maternal, Fetal, Newborn and Child Healthcare Strategies, Department of Obstetrics and Gynaecology Steve Biko Academic Hospital, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Trevi', 'Initials': 'T', 'LastName': 'Spence', 'Affiliation': 'Department of Obstetrics and Gynaecology, New Somerset Hospital, Cape Town, South Africa.'}, {'ForeName': 'Symphorien C', 'Initials': 'SC', 'LastName': 'Ntambua', 'Affiliation': 'Department of Health, Department of Obstetrics and Gynaecology, Bongani Regional Hospital, Free State, Hartbeespoort, South Africa.'}, {'ForeName': 'Justus', 'Initials': 'J', 'LastName': 'Hofmeyr', 'Affiliation': 'Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand, Walter Sisulu, and Fort Hare, East London, South Africa.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13963']
228,34609359,The Pain Course: a randomised controlled trial and economic evaluation of an internet-delivered pain management program.,"ABSTRACT


There is interest in the potential of Internet-delivered programs to cost-effectively increase access to pain management for people with chronic pain. However, few large-scale clinical and economic evaluations have been undertaken. Using a randomised controlled trial design, the current study (n = 659) examined the clinical efficacy, cost-effectiveness, and cost utility of an Internet-delivered pain management program for people with mixed chronic pain conditions when delivered with optional clinician support. The treatment group reported significant improvements in disability, depression, anxiety, average pain intensity, and quality-adjusted life years (QALYs), compared with control, and exhibited relatively high levels of treatment engagement and satisfaction. Each additional clinical improvement (defined as ≥ 30% improvement) produced by the intervention, over control, was associated with a cost of $48, $27, $38, and $83 for disability, depression, anxiety, and average pain intensity, respectively. Gaining one QALY was associated with a cost of $152 or $11,910 per QALY when an 80% probability criterion for cost utility was applied. The program itself was associated a relatively small, fixed, cost per patient but was not cost saving over the brief intervention period. The findings support the clinical efficacy and cost-effectiveness of Internet-delivered programs with ""on demand"" clinician support as a way to increase access to pain management. Key limitations of the current study include the use of a waitlist-control group, a short follow-up period, and the focus on governmental healthcare costs. Further evaluation of these programs is necessary if they are scaled up and offered as routine care.",2022,"The treatment group reported significant improvements in disability, depression, anxiety, average pain intensity and quality-adjusted life-years (QALYs), compared to control, and exhibited relatively high levels of treatment engagement and satisfaction.","['people with mixed chronic pain conditions', 'people with chronic pain']",['internet-delivered pain management program'],"['cost (AUD', 'disability, depression, anxiety and average pain intensity', 'clinical efficacy, cost-effectiveness and cost-utility', 'disability, depression, anxiety, average pain intensity and quality-adjusted life-years (QALYs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.02896,"The treatment group reported significant improvements in disability, depression, anxiety, average pain intensity and quality-adjusted life-years (QALYs), compared to control, and exhibited relatively high levels of treatment engagement and satisfaction.","[{'ForeName': 'Blake F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Karin', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Fogliati', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Dudeney', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Nielssen', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Gandy', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Staples', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'Scott', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Andreea I', 'Initials': 'AI', 'LastName': 'Heriseanu', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Madelyne A', 'Initials': 'MA', 'LastName': 'Bisby', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hathway', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Nickolai', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'eCentreClinic, School of Psychological Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Schroeder', 'Affiliation': 'Centre for Health Economy, Macquarie University, Sydney, Australia.'}]",Pain,['10.1097/j.pain.0000000000002507']
229,34613339,Sixty-Day Mortality of Patients With Metastatic Colorectal Cancer Randomized to Systemic Treatment vs Primary Tumor Resection Followed by Systemic Treatment: The CAIRO4 Phase 3 Randomized Clinical Trial.,"Importance


The role of primary tumor resection (PTR) in synchronous patients with metastatic colorectal cancer (mCRC) who had unresectable metastases and few or absent symptoms of their primary tumor is unclear. Studying subgroups with low postoperative mortality may identify patients who potentially benefit from PTR.
Objective


To determine the difference in 60-day mortality between patients randomized to systemic treatment only vs PTR followed by systemic treatment, and to explore risk factors associated with 60-day mortality.
Design, Setting, and Participants


CAIRO4 is a randomized phase 3 trial initiated in 2012 in which patients with mCRC were randomized to systemic treatment only or PTR followed by systemic treatment with palliative intent. This multicenter study was conducted by the Danish and Dutch Colorectal Cancer Group in general and academic hospitals in Denmark and the Netherlands. Patients included between August 2012 and December 2019 with histologically proven colorectal cancer, unresectable metastases, and a primary tumor with few or absent symptoms were eligible.
Interventions


Systemic treatment, consisting of fluoropyrimidine-based chemotherapy with bevacizumab vs PTR followed by fluoropyrimidine-based chemotherapy with bevacizumab.
Main Outcomes and Measures


The aim of the current analysis was to compare 60-day mortality rates in both treatment arms. A secondary aim was the identification of risk factors for 60-day mortality in the treatment arms. These aims were not predefined in the study protocol.
Results


A total of 196 patients were included in the intention-to-treat analysis (112 [57%] men; median [IQR] age, 65 [59-70] years). Sixty-day mortality was 3% (95% CI, 1%-9%) in the systemic treatment arm and 11% (95% CI, 6%-19%) in the PTR arm (P = .03). In a per-protocol analysis, 60-day mortality was 2% (95% CI, 1%-7%) vs 10% (95% CI, 5%-18%; P = .048). Patients with elevated serum levels of lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and/or neutrophils who were randomized to PTR had a significantly higher 60-day mortality than patients without these characteristics.
Conclusions and Relevance


Patients with mCRC who were randomized to PTR followed by systemic treatment had a higher 60-day mortality than patients randomized to systemic treatment. Especially patients randomized to the PTR arm with elevated serum levels of lactate dehydrogenase, neutrophils, aspartate aminotransferase, and/or alanine aminotransferase were at high risk of postoperative mortality. Final study results on overall survival have to be awaited.
Trial Registration


ClinicalTrials.gov Identifier: NCT01606098.",2021,"Sixty-day mortality was 3% (95% CI, 1%-9%) in the systemic treatment arm and 11% (95% CI, 6%-19%) in the PTR arm (P = .03).","['Patients with mCRC', 'Patients with elevated serum levels of lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and/or neutrophils who were randomized to', 'synchronous patients with metastatic colorectal cancer (mCRC) who had unresectable metastases and few or absent symptoms of their primary tumor', 'Patients included between August 2012 and December 2019 with histologically proven colorectal cancer, unresectable metastases, and a primary tumor with few or absent symptoms were eligible', 'A total of 196 patients were included in the intention-to-treat analysis (112 [57%] men; median [IQR] age, 65 [59-70] years', 'Danish and Dutch Colorectal Cancer Group in general and academic hospitals in Denmark and the Netherlands', 'patients with mCRC']","['Systemic Treatment vs Primary Tumor Resection', 'Systemic Treatment', 'systemic treatment only or PTR followed by systemic treatment with palliative intent', 'primary tumor resection (PTR', 'PTR', 'fluoropyrimidine-based chemotherapy with bevacizumab vs PTR followed by fluoropyrimidine-based chemotherapy with bevacizumab']","['Sixty-day mortality', 'elevated serum levels of lactate dehydrogenase, neutrophils, aspartate aminotransferase, and/or alanine aminotransferase', '60-day mortality rates', '60-day mortality', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1285530', 'cui_str': 'Palliative intent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",196.0,0.41015,"Sixty-day mortality was 3% (95% CI, 1%-9%) in the systemic treatment arm and 11% (95% CI, 6%-19%) in the PTR arm (P = .03).","[{'ForeName': 'Dave E W', 'Initials': 'DEW', 'LastName': 'van der Kruijssen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Sjoerd G', 'Initials': 'SG', 'LastName': 'Elias', 'Affiliation': 'Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Geraldine R', 'Initials': 'GR', 'LastName': 'Vink', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Karlijn L', 'Initials': 'KL', 'LastName': 'van Rooijen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Jorine', 'Initials': 'J', 'LastName': ""'t Lam-Boer"", 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mol', 'Affiliation': 'Clinical Research Department, Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, the Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Johannes H W', 'Initials': 'JHW', 'LastName': 'de Wilt', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2021.4992']
230,34614204,A randomized controlled trial of the effect of ramosetron on postoperative restoration of bowel motility after gynecologic laparoscopic surgery.,"OBJECTIVE


To investigate the effect of ramosetron after gynecological laparoscopic surgery on the recovery of bowel function.
METHODS


A prospective randomized controlled trial conducted at Kyung Hee University hospital, South Korea, from August 2016 to September 2017. Patients were randomized to receive either 10 mg dexamethasone before induction of anesthesia (control group C), followed by intravenous administration of patient-controlled analgesia (IV-PCA) or 2 ml normal saline before induction of anesthesia and 0.6 mg ramosetron (study group R) administered with IV-PCA.
RESULTS


A total of 88 patients were enrolled. Times to first flatus (group C 23.98 ± 6.31 vs. group R 27.14 ± 9.56 h; P = 0.148) and first defecation (group C 36.16 ± 16.04 vs. group R 43.41 ± 20.01 h; P = 0.138) showed no statistically significant differences. No significant differences were observed in the frequency of postoperative nausea and vomiting (PONV) and demand for additional analgesics. Multiple linear regression for analysis of factors affecting time to first flatus revealed no significant results.
CONCLUSION


Ramosetron did not delay bowel movement recovery after gynecologic laparoscopic surgery and was as effective as dexamethasone in regulating PONV. Ramosetron can be used with IV-PCA without concerns about delay in recovery of bowel function.
CLINICALTRIALS


gov registration number: NCT02849483.",2022,No significant differences were observed in the frequency of postoperative nausea and vomiting (PONV) and demand for additional analgesics.,"['88 patients were enrolled', 'after gynecologic laparoscopic surgery', 'Kyung Hee University hospital, South Korea, from August 2016 to September 2017']","['gynecological laparoscopic surgery', 'dexamethasone before induction of anesthesia (control group C), followed by intravenous administration of patient-controlled analgesia (IV-PCA) or 2\xa0mL normal saline before induction of anesthesia and 0.6\xa0mg ramosetron (study group R) administered with IV-PCA', 'dexamethasone', 'Ramosetron', 'ramosetron']","['postoperative restoration of bowel motility', 'delay bowel movement recovery', 'first defecation', 'frequency of postoperative nausea and vomiting (PONV) and demand for additional analgesics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0526950', 'cui_str': 'ramosetron'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",88.0,0.139162,No significant differences were observed in the frequency of postoperative nausea and vomiting (PONV) and demand for additional analgesics.,"[{'ForeName': 'Hee Yong', 'Initials': 'HY', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital, Seoul, South Korea.'}, {'ForeName': 'Youngsoon', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ann Hee', 'Initials': 'AH', 'LastName': 'You', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital, Seoul, South Korea.'}, {'ForeName': 'Yeon Jin', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital, Seoul, South Korea.'}, {'ForeName': 'Mi Kyeong', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital, Seoul, South Korea.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13969']
231,34622721,"Oral Propolis, Nutritional Status and Quality of Life with Chemotherapy for Breast Cancer: A Randomized, Double-Blind Clinical Trial.","Chemotherapy-induced side effects include an impaired nutritional status and reduced quality of life in patients. The contribution of propolis, as a co-adjuvant nutritional supplement in cancer treatment, is suggested due to its functional characteristics and biological activities such as antitumoral activity, DNA protection, free radicals scavenging, and immune stimulation; however, clinical trials to support these effects in cancer patients are necessary. This is a randomized, double-blind, placebo-controlled clinical trial to assess the effect of propolis vs. placebo on the nutritional status and quality of life in patients diagnosed with breast cancer who are receiving chemotherapy (No. IRCT2016062828679N1). A total of 60 patients from the Oncology Clinic at Tohid Hospital, Sanandaj, Iran were randomized to receive propolis (250 mg/ two times per day for three  months) or a placebo. After three months of intervention, energy intake of patients who received propolis increased significantly compared to placebo group ( p  = 0.000). The quality of life also showed significant improvements in patients receiving propolis, particularly with regards to emotional functioning ( p  = 0.03), global QoL functioning ( p  = 0.04), and financial difficulties ( p  = 0.01) compared to the control group. Propolis is suggested an adequate and safe therapeutic option to improve the nutritional status and quality of life in patients diagnosed with breast cancer receiving chemotherapy. However, more trials are needed in order to draw robust conclusions with regard to its efficacy in chemotherapy-induced side effects.",2022,"The quality of life also showed significant improvements in patients receiving propolis, particularly with regards to emotional functioning ( p  = 0.03), global QoL functioning ( p  = 0.04), and financial difficulties ( p  = 0.01) compared to the control group.","['Breast Cancer', 'patients diagnosed with breast cancer who are receiving chemotherapy (No. IRCT2016062828679N1', 'patients', '60 patients from the Oncology Clinic at Tohid Hospital, Sanandaj, Iran', 'patients diagnosed with breast cancer receiving chemotherapy']","['placebo', 'propolis', 'propolis vs. placebo']","['Oral Propolis, Nutritional Status and Quality of Life', 'financial difficulties', 'emotional functioning', 'energy intake of patients who received propolis', 'global QoL functioning', 'nutritional status and quality of life', 'quality of life']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",60.0,0.388356,"The quality of life also showed significant improvements in patients receiving propolis, particularly with regards to emotional functioning ( p  = 0.03), global QoL functioning ( p  = 0.04), and financial difficulties ( p  = 0.01) compared to the control group.","[{'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Davoodi', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Yousefinejad', 'Affiliation': 'Liver and Digestive Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Bayazid', 'Initials': 'B', 'LastName': 'Ghaderi', 'Affiliation': 'Liver and Digestive Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Mohammad Esmail', 'Initials': 'ME', 'LastName': 'Akbari', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shoaleh', 'Initials': 'S', 'LastName': 'Darvishi', 'Affiliation': 'Food Sciences and Technology Department, Sanandaj Branch, Islamic Azad University, Sanandaj, Iran.'}, {'ForeName': 'Yadollah', 'Initials': 'Y', 'LastName': 'Mehrabi', 'Affiliation': 'Epidemiology Department, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Darvishi', 'Affiliation': 'Nutrition Department, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Nutrition and cancer,['10.1080/01635581.2021.1988118']
232,34652243,Effects of voice rehabilitation in people with MS: A double-blinded long-term randomized controlled trial.,"BACKGROUND


Hypophonia is a prevailing problem in people with multiple sclerosis (PwMS). However, evidence supporting the effectiveness of voice rehabilitation is lacking.
OBJECTIVE


The aim of this study was to identify the most effective method to reduce hypophonia.
METHODS


In this randomized controlled trial, 44 PwMS were randomized to intensive and high-effort voice treatment groups, the LSVT-LOUD ® , and conventional treatment group. Subjects received 16 treatments (4 sessions/week) lasting 45 minutes. The primary outcome was voice intensity (dB) in monologue, vocalization, and sentences while voice handicap index (VHI) measured voice self-perception. Outcomes were assessed by a blinded observer at baseline, post-treatment, and 15-month follow-up (FU).
RESULTS


Linear models revealed a significant post-intervention between-group mean difference in favor of LSVT-LOUD for monologue: +6.3 dB (95% CI: 2.5 to 10.1); vocalization: +7.4 dB (95% CI: 2.3 to 12.5); and sentences: +9.5 dB (95% CI: 4.7 to 14.3). However, 43.7% PwMS in the LSVT-LOUD and 10% in the conventional treatment group obtained a full recovery of voice intensity (>60 dB) post-treatment, Fisher's test = 13.3,  p  < 0.01. However, these improvements were not maintained at FU. Between-group differences at VHI were -10.8 (95% CI: -21.2 to -0.4) and -11.3 (95% CI: -24.3 to -1.7) in favor of LSVT-LOUD at post and FU.
CONCLUSION


LSVT-LOUD can be a valid treatment to increase voice intensity in PwMS. However, results suggest the need for FU interventions targeting maintenance.",2022,"RESULTS


Linear models revealed a significant post-intervention between-group mean difference in favor of LSVT-LOUD for monologue: +6.3 dB (95% CI: 2.5 to 10.1); vocalization: +7.4 dB (95% CI: 2.3 to 12.5); and sentences: +9.5 dB (95% CI: 4.7 to 14.3).","['people with multiple sclerosis (PwMS', 'people with MS', '44 PwMS']","['voice rehabilitation', 'LSVT-LOUD', 'LSVT-LOUD ® , and conventional treatment group']","['full recovery of voice intensity', 'LSVT-LOUD', 'voice intensity (dB) in monologue, vocalization, and sentences while voice handicap index (VHI) measured voice self-perception']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0042932', 'cui_str': 'Singing, Animal'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}]",44.0,0.266506,"RESULTS


Linear models revealed a significant post-intervention between-group mean difference in favor of LSVT-LOUD for monologue: +6.3 dB (95% CI: 2.5 to 10.1); vocalization: +7.4 dB (95% CI: 2.3 to 12.5); and sentences: +9.5 dB (95% CI: 4.7 to 14.3).","[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Crispiatico', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milano, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Baldanzi', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milano, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Napoletano', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milano, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tomasoni', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Tedeschi', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milano, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Groppo', 'Affiliation': 'Ospedale San Paolo-Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo, Milano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rovaris', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Vitali', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Cattaneo', 'Affiliation': 'Department of of Pathophysiology and Transplantation, University of Milano, Milano, Italy.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211051059']
233,34654493,"Articaine Infiltration Versus Lidocaine Inferior Alveolar Nerve Block for Anesthetizing Primary Mandibular Molars: A Randomized, Controlled, Double-Blind Pilot Study.","Purpose:  The purpose of this study was to compare the effectiveness of articaine local infiltration to lidocaine inferior alveolar nerve block (IANB) for restorative treatment of primary mandibular molars (PMM).  Methods:  Four- to 10-year-old children who needed PMM restorations were enrolled according to inclusion criteria and randomly allocated into the articaine or lidocaine group. One operator administered all local anesthesia. Using the Modified Behavioral Pain Scale (MBPS), 15 trained and calibrated examiners, blinded to LA type, evaluated the subjects' reactions during LA administration and treatment. Children rated their experience using the Wong-Baker FACES Pain Rating Scale (WBS). Subjects' blood pressure and pulse throughout the visits were recorded. Statistical analysis included independent t-tests, Mann Whitney-U, and repeated measures analysis of variance (P<0.05). Examiner reliability was determined by Cohen's kappa score.  Results:  Thirty subjects (53 percent male; mean age: 6.3 years) participated. While the mean total scores for articaine (2.13 MBPS; 0.53 WBS) were better than for lidocaine (3.07 MBPS; 1.33 WBS), there were no statistically significant differences between groups. All physiological measurements were within normal limits.  Conclusions:  This pilot study indicated that articaine infiltration might be as effective as a lidocaine inferior alveolar nerve block for restorative treatment of primary mandibular molars; however, a larger sample is required to confirm these findings.",2021,"While the mean total scores for articaine (2.13 MBPS; 0.53 WBS) were better than for lidocaine (3.07 MBPS; 1.33 WBS), there were no statistically significant differences between groups.","['primary mandibular molars (PMM', 'Anesthetizing Primary Mandibular Molars', 'Results:  Thirty subjects (53 percent male; mean age: 6.3 years) participated', 'primary mandibular molars', '10-year-old children who needed PMM restorations']","['Lidocaine Inferior Alveolar Nerve Block', 'lidocaine', 'lidocaine inferior alveolar nerve block (IANB', 'articaine or lidocaine', 'articaine', 'Articaine']","['Baker FACES Pain Rating Scale (WBS', 'Examiner reliability', 'Modified Behavioral Pain Scale (MBPS', 'mean total scores']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0070302', 'cui_str': 'pentamethylmelamine'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}]","[{'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004903', 'cui_str': 'Beckwith-Wiedemann syndrome'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",53.0,0.0350339,"While the mean total scores for articaine (2.13 MBPS; 0.53 WBS) were better than for lidocaine (3.07 MBPS; 1.33 WBS), there were no statistically significant differences between groups.","[{'ForeName': 'Ivan L', 'Initials': 'IL', 'LastName': 'Zhang', 'Affiliation': 'Dr. Zhang is a pediatric dentist in private practice in Washington, D.C., USA.'}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Kratunova', 'Affiliation': 'Dr. Kratunova is clinical associate professor, Department of Pediatric Dentistry, College of Dentistry, University of Illinois at Chicago, Chicago, Ill., USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Sha', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Marion', 'Affiliation': 'Dr. Marion is a clinical assistant professor and predoctoral director, Department of Pediatric Dentistry, College of Dentistry, University of Illinois at Chicago, Chicago, Ill., USA;, Email: evekrat@uic.edu.'}, {'ForeName': 'Marcio A', 'Initials': 'MA', 'LastName': 'da Fonseca', 'Affiliation': 'Dr. da Fonseca is Chicago Dental Society Foundation professor and head, Department of Pediatric Dentistry, College of Dentistry, University of Illinois at Chicago, Chicago, Ill., USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Dr. Han is an assistant professor and graduate program director, Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Illinois at Chicago, Chicago, Ill., USA.'}]",Pediatric dentistry,[]
234,34612092,Point-of-care viral load testing among adolescents and young adults living with HIV in Haiti: a randomized control trial.,"HIV viral load (VL) monitoring can reinforce antiretroviral therapy (ART) adherence. Standard VL testing requires high laboratory capacity and coordination between clinic and laboratory which can delay results. A randomized trial comparing point-of-care (POC) VL testing to standard VL testing among 150 adolescents and young adults, ages 10-24 years, living with HIV in Haiti determined if POC VL testing could return faster results and improve ART adherence and viral suppression. Participants received a POC VL test with same-day result (POC arm) or a standard VL test with result given 1 month later (SOC arm). POC arm participants were more likely to receive a test result within 6 weeks than SOC arm participants (94.7% vs. 80.1%; p1000 copies/ml and low self-reported ART adherence was stronger in the POC arm (OR: 6.57; 95%CI: 2.12-25.21) than the SOC arm (OR: 2.62; 95%CI: 0.97-7.44) suggesting more accurate self-report in the POC arm. POC VL testing was effectively implemented in this low-resource setting with faster results and is a pragmatic intervention that may enable clinicians to identify those with high VL to provide enhanced counseling or regimen changes sooner. Trial registration:  ClinicalTrials.gov identifier: NCT03288246.",2022,POC arm participants were more likely to receive a test result within 6 weeks than SOC arm participants (94.7% vs. 80.1%; p1000 copies/ml and low self-reported ART adherence was stronger in the POC arm (OR: 6.57; 95%CI: 2.12-25.21) than the SOC arm (OR: 2.62; 95%CI: 0.97-7.44) suggesting more accurate self-report in the POC arm.,"['adolescents and young adults living with HIV in Haiti', '150 adolescents and young adults, ages 10-24 years, living with HIV in Haiti determined if POC VL testing']","['POC VL test with same-day result (POC arm) or a standard VL test', 'care (POC) VL testing to standard VL testing']","['ART adherence', 'ART adherence and viral suppression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",150.0,0.174303,POC arm participants were more likely to receive a test result within 6 weeks than SOC arm participants (94.7% vs. 80.1%; p1000 copies/ml and low self-reported ART adherence was stronger in the POC arm (OR: 6.57; 95%CI: 2.12-25.21) than the SOC arm (OR: 2.62; 95%CI: 0.97-7.44) suggesting more accurate self-report in the POC arm.,"[{'ForeName': 'Lindsey K', 'Initials': 'LK', 'LastName': 'Reif', 'Affiliation': 'Department of Medicine, Center for Global Health, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Marie Elmase', 'Initials': 'ME', 'LastName': 'Belizaire', 'Affiliation': 'GHESKIO Center, Port-au-Prince, Haiti.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rouzier', 'Affiliation': 'Department of Medicine, Center for Global Health, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Seo', 'Affiliation': 'Department of Medicine, Center for Global Health, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Severe', 'Affiliation': 'GHESKIO Center, Port-au-Prince, Haiti.'}, {'ForeName': 'Joseph-Marie', 'Initials': 'JM', 'LastName': 'Bajo Joseph', 'Affiliation': 'GHESKIO Center, Port-au-Prince, Haiti.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': 'GHESKIO Center, Port-au-Prince, Haiti.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Apollon', 'Affiliation': 'GHESKIO Center, Port-au-Prince, Haiti.'}, {'ForeName': 'Jean W', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': 'Department of Medicine, Center for Global Health, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNairy', 'Affiliation': 'Department of Medicine, Center for Global Health, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Batya', 'Initials': 'B', 'LastName': 'Elul', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Medicine, Center for Global Health, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Arpadi', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, NY, USA.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, NY, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'Gertrude H. Sergievsky Center, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}]",AIDS care,['10.1080/09540121.2021.1981816']
235,34637519,"Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When Coadministered With a Tetanus, Diphtheria, and Acellular Pertussis Vaccine.","BACKGROUND


Prevention of respiratory syncytial virus (RSV) disease in infants is an unmet vaccine need, and maternal immunization is a potential strategy to address this need. This study evaluated concomitant administration of RSV stabilized prefusion F subunit vaccine (RSVpreF) and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) in healthy, nonpregnant women 18‒49 years of age.
METHODS


In this phase 2b, multicenter, placebo-controlled, observer-blind, noninferiority study, participants were randomized to receive RSVpreF in a range of doses and formulations with Tdap or alone, or Tdap alone. Safety and immunogenicity were assessed.
RESULTS


Local reactions and systemic events were generally similar across vaccine groups. Noninferiority of anti-RSV-A and anti-RSV-B immune responses induced by RSVpreF with Tdap was demonstrated compared to RSVpreF alone. Noninferiority of anti-diphtheria toxoid and anti-tetanus toxoid immune responses after administration of RSVpreF with Tdap was demonstrated compared to Tdap alone; noninferiority was not met for anti-pertussis component responses.
CONCLUSIONS


RSVpreF was safe and well tolerated when administered with Tdap or alone in nonpregnant women 18‒49 years of age. Immune responses induced by Tdap administered with RSVpreF were noninferior for the tetanus and diphtheria components of Tdap, but not for pertussis.
CLINICAL TRIALS REGISTRATION


NCT04071158.",2022,"Immune responses induced by Tdap administered with RSVpreF were noninferior for the tetanus and diphtheria components of Tdap, but not for pertussis.","['non-pregnant women 18‒49 years of age', 'healthy, non-pregnant women 18‒49 years of age']","['Tetanus, Diphtheria, and Acellular Pertussis Vaccine', 'Tdap or alone, or Tdap alone', 'anti-diphtheria toxoid', 'RSV stabilized prefusion F subunit vaccine (RSVpreF) and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap', 'Tdap administered with RSVpreF', 'RSVpreF', 'Respiratory Syncytial Virus Prefusion F Vaccine', 'Tdap', 'placebo', 'RSVpreF with Tdap']","['safe and well tolerated', 'Safety and Immunogenicity', 'Safety and immunogenicity', 'systemic events']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0040555', 'cui_str': 'Toxoid'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.143004,"Immune responses induced by Tdap administered with RSVpreF were noninferior for the tetanus and diphtheria components of Tdap, but not for pertussis.","[{'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Peterson', 'Affiliation': 'J. Lewis Research, Inc, and Foothill Family Clinic, Salt Lake City, Utah, USA.'}, {'ForeName': 'Agnieszka M', 'Initials': 'AM', 'LastName': 'Zareba', 'Affiliation': 'Pfizer Vaccine Research and Development, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitz-Patrick', 'Affiliation': 'East-West Medical Research Institute, Honolulu, Hawaii, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Essink', 'Affiliation': 'Meridian Clinical Research, Omaha, Nebraska, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': 'Pfizer Vaccine Research and Development, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, New York, USA.'}, {'ForeName': 'Dhawal', 'Initials': 'D', 'LastName': 'Chelani', 'Affiliation': 'Pfizer Vaccine Research and Development, Hurley, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Radley', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, New York, USA.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, New York, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, New York, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, New York, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': 'Pfizer Vaccine Research and Development, Pearl River, New York, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiab505']
236,34693735,"Ex Vivo  Renal Stone Dusting: Impact of Laser Modality, Ureteral Access Sheath, and Suction on Total Stone Clearance.","Introduction and Objectives:  Conventional renal stone dusting is challenging; the holmium (Ho:YAG) laser and holmium with  MOSES  effect (Ho:YAG- MOSES ) fail to uniformly produce fragments ≤100 μm (i.e., dust). The superpulse thulium fiber laser (sTFL) may more effectively render uroliths into ""dust,"" and may thus improve stone-free rates. Accordingly, we performed  ex vivo  evaluations with all three laser modalities, assessing stone fragments and stone clearance.  Methods:  Seventy-two  ex vivo  porcine kidney-ureter models were divided into 12 groups of 6: laser type (Ho:YAG, Ho:YAG- MOSES , sTFL), ureteroscope with and without applied suction, and the presence or absence of a 14F ureteral access sheath (UAS). Calcium oxalate stones were preweighed and implanted into each kidney via a pyelotomy. Stones were treated at 16W using dusting settings of 0.4J × 40Hz (Ho:YAG), 0.2J × 80Hz (Ho:YAG- MOSES ), and 0.2J × 80Hz (sTFL) for up to 20 minutes. No stone basketing was performed. Kidneys were bivalved and residual fragments were collected, dried, weighed, and sieved to determine fragment size and stone clearance.  Results:  Initial stone mass (mg), procedure time (seconds), and laser energy expenditure (kJ) were similar in all 12 groups. The greatest stone clearance was seen with sTFL + suction + UAS (94%) compared with a conventional technique (Ho:YAG + no suction + no UAS) (65%,  p  < 0.01). The use of sTFL provided greater stone clearance than Ho:YAG or Ho:YAG- MOSES . Aspiration improved stone clearance for sTFL ( p  = 0.01), but not for Ho:YAG or Ho:YAG- MOSES , consistent with the creation of smaller fragments with sTFL. Presence of a 14F UAS improved stone clearance in all scenarios ( p  < 0.01).  Conclusions:  In this  ex vivo  study, stone clearance was optimized under the following conditions: sTFL, 14F UAS, and aspiration. This combination resulted in 94% of stone fragments being cleared; the 6% remaining fragments were all <2 mm. In all scenarios, deployment of a 14F UAS improved stone clearance.",2022,"Aspiration improved stone clearance for sTFL (p=0.01) but not for Ho:YAG or Ho:YAG-MOSES, consistent with the creation of smaller fragments with sTFL.",['Seventy-two ex-vivo porcine kidney-ureter models'],"['0.4Jx40Hz (Ho:YAG) 0.2Jx80Hz', 'superpulse thulium fiber laser (sTFL', 'Laser Modality, Ureteral Access Sheath, and Suction', 'laser type (Ho:YAG, Ho:YAG-MOSES, sTFL), ureteroscope (URS) with and without applied suction, and presence or absence of a 14Fr ureteral access sheath (UAS', 'conventional technique (Ho:YAG+no suction+no UAS', '0.2Jx80Hz (sTFL', 'sTFL+suction+UAS', 'sTFL', 'holmium laser (Ho:YAG']","['Total Stone Clearance', 'Calcium oxalate stones', 'stone clearance', 'procedure time (sec), and laser energy expenditure (kJ', 'greatest stone clearance']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184213', 'cui_str': 'Ureteroscope'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0006706', 'cui_str': 'Calcium Oxalate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",,0.0504969,"Aspiration improved stone clearance for sTFL (p=0.01) but not for Ho:YAG or Ho:YAG-MOSES, consistent with the creation of smaller fragments with sTFL.","[{'ForeName': 'Pengbo', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Akhil', 'Initials': 'A', 'LastName': 'Peta', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brevik', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Raphael B', 'Initials': 'RB', 'LastName': 'Arada', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Ayad', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Afyouni', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Limfueco', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Palma', 'Affiliation': 'Biostatistics, Epidemiology & Research Design Unit, Institute for Clinical and Translational Science, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Roshan M', 'Initials': 'RM', 'LastName': 'Patel', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Landman', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}, {'ForeName': 'Ralph V', 'Initials': 'RV', 'LastName': 'Clayman', 'Affiliation': 'Department of Urology, University of California, Irvine, Orange, California, USA.'}]",Journal of endourology,['10.1089/end.2021.0544']
237,34695232,Comparison between 200 μg and 800 μg of vaginal misoprostol for cervical ripening before operative hysteroscopy: A randomized controlled trial.,"OBJECTIVE


To compare between 200 and 800 μg of vaginal misoprostol for cervical ripening before operative hysteroscopy.
METHODS


Quadruple-blind randomized clinical trial conducted between November 2019 and September 2020 involving 76 patients undergoing cervical dilatation before surgical hysteroscopy at teaching hospitals in Pernambuco, Brazil. Women received the vaginal misoprostol dosage of 200 or 800 μg,10-12 h before operative hysteroscopy. The cervical width was the primary outcome, and secondary outcomes were patient satisfaction, adverse effects, surgical complications, and duration of cervical dilatation. Chi-square tests of association, Fisher's exact and Mann-Whitney U tests were used with an α error of <5%.
RESULTS


There was no statistical difference between the groups in the mean of the cervical width (800 μg: 6.5 ± 1.6 mm vs 200 μg: 5.8 ± 1.8 mm, P = 0.055), patient satisfaction, and surgical findings, but the duration of cervical dilatation was lower in the 800-μg group (28.16 ± 28.5 s vs 41.97 ± 31.0 s, P = 0.035). Among the adverse effects, diarrhea was more frequent in the 800-μg group with statistical difference (100% vs 0%; P = 0.01).
CONCLUSION


For cervical ripening, 200 μg misoprostol is equally effective with fewer adverse effects than 800 μg before operative hysteroscopy.
CLINICALTRIALS


gov: NCT04152317. https://clinicaltrials.gov/ct2/show/NCT04152317.",2022,"There was no statistical difference between the groups in the mean of the cervical width (800 μg: 6.5 ± 1.6 mm vs 200 μg: 5.8 ± 1.8 mm, P = 0.055), patient satisfaction, and surgical findings, but the duration of cervical dilatation was lower in the 800-μg group (28.16 ± ","['November 2019 and September 2020 involving 76 patients undergoing cervical dilatation before surgical hysteroscopy at teaching hospitals in Pernambuco, Brazil', 'cervical ripening before operative hysteroscopy', '28.5', '200 and 800\xa0μg of vaginal misoprostol for cervical ripening before operative hysteroscopy']","['vaginal misoprostol', 'misoprostol']","['adverse effects, diarrhea', 'mean of the cervical width', 'duration of cervical dilatation', 'patient satisfaction, adverse effects, surgical complications, and duration of cervical dilatation', 'adverse effects']","[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0600454', 'cui_str': 'Cervical Ripening'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",76.0,0.243162,"There was no statistical difference between the groups in the mean of the cervical width (800 μg: 6.5 ± 1.6 mm vs 200 μg: 5.8 ± 1.8 mm, P = 0.055), patient satisfaction, and surgical findings, but the duration of cervical dilatation was lower in the 800-μg group (28.16 ± ","[{'ForeName': 'Maria da Conceição Farias Souto', 'Initials': 'MDCFS', 'LastName': 'Maior', 'Affiliation': 'Postgraduate Program in Integral Health, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.'}, {'ForeName': 'Alex Sandro Rolland', 'Initials': 'ASR', 'LastName': 'Souza', 'Affiliation': 'Postgraduate Program in Integral Health, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.'}, {'ForeName': 'Gustavo Fonseca de Albuquerque', 'Initials': 'GFA', 'LastName': 'Souza', 'Affiliation': 'Biological Sciences and Health Center, Catholic University Pernambuco (UNICAP), Recife, Pernambuco, Brazil.'}, {'ForeName': 'Aurélio Antônio Ribeiro', 'Initials': 'AAR', 'LastName': 'da Costa', 'Affiliation': 'Postgraduate Program in Integral Health, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13984']
238,34666621,"An Evaluation of the Effects of Active Game Play on Cognition, Quality of Life and Depression for Older People with Dementia.","OBJECTIVES


This pilot study was intended to evaluate the effects of active game play on cognition, quality of life, and depression for older people with dementia.
METHODS


Thirty-eight older people with dementia were recruited. Eighteen people received eight-week active game play using Xbox 360 Kinect. Twenty people received their usual care. The Mini Mental State Examination, Quality of Life-Alzheimer's Disease and Cornell Scale for Depression in Dementia were used to measure the outcomes.
RESULTS


The results showed that there was no significant improvement on the mean scores of Mini Mental State Examination ( P  = .252), however, the active game play increased the mean score of Quality of Life-Alzheimer's Disease ( P  = .005), and reduced the mean score of Cornell Scale for Depression in Dementia ( P  = .001) in comparison with the usual care group.
CONCLUSIONS


The study demonstrated that the active game play was effective in improving quality of life and alleviating depression in older people with dementia.
CLINICAL IMPLICATIONS


Findings highlight the potential for gaming as a non-pharmacological interventions for older people with dementia.",2022,"The results showed that there was no significant improvement on the mean scores of Mini Mental State Examination ( P  = .252), however, the active game play increased the mean score of Quality of Life-Alzheimer's Disease ( P  = .005), and reduced the mean score of Cornell Scale for Depression in Dementia ( P  = .001) in comparison with the usual care group.
","['Older People with Dementia', 'Twenty people received their usual care', 'older people with dementia', 'Thirty-eight older people with dementia were recruited', 'Eighteen people received eight-week active game play using Xbox 360 Kinect']",['Active Game Play'],"[""mean score of Quality of Life-Alzheimer's Disease"", 'Cognition, Quality of Life and Depression', 'cognition, quality of life, and depression', 'mean score of Cornell Scale for Depression in Dementia', 'quality of life and alleviating depression', 'mean scores of Mini Mental State Examination', ""Mini Mental State Examination, Quality of Life-Alzheimer's Disease and Cornell Scale for Depression""]","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C4319607', 'cui_str': '360'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}]",38.0,0.0391171,"The results showed that there was no significant improvement on the mean scores of Mini Mental State Examination ( P  = .252), however, the active game play increased the mean score of Quality of Life-Alzheimer's Disease ( P  = .005), and reduced the mean score of Cornell Scale for Depression in Dementia ( P  = .001) in comparison with the usual care group.
","[{'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Nursing Department, Qianjiang College, Hangzhou Normal University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'School of Computing and Information Technology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, Qianjiang College, Hangzhou Normal University, Hangzhou, Zhejiang, China.'}]",Clinical gerontologist,['10.1080/07317115.2021.1980170']
239,34607760,Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgeries: A Randomized Controlled Trial.,"OBJECTIVE(S)


This study was designed to evaluate the efficacy and safety of serratus anterior plane block (SAPB) as an analgesic technique for thoracotomies in pediatric patients.
DESIGN


Double-blinded randomized controlled trial.
SETTING


A single-center study at Aboelrish Pediatric Hospital, one tertiary hospital of Cairo University Hospitals.
PARTICIPANTS


Seventy pediatric patients aged six months-to-three years scheduled for thoracotomies.
INTERVENTIONS


Patients were randomized into two groups, group SF and group F. Group SF received an ultrasound-guided SAPB (n = 35), whereas group F (n = 35) did not. All groups received an intraoperative fentanyl infusion (at 0.5 μg/kg /h).
MEASUREMENTS


The primary outcome was the total dose of postoperatively administrated fentanyl in the first 24 hours. The secondary outcomes included the total dose of intraoperative additional fentanyl boluses; time of the first postoperative rescue analgesia; and postoperative Face, Legs, Activity, Cry, Consolability scale (FLACC) score values.
MAIN RESULTS


The main results of this study showed that the administrated fentanyl in the 24 hours postoperatively was significantly lower in SF group than in F group (p value ˂ 0.001). In addition, significant decreases of the postoperative FLACC pain score (p value ˂ 0.001), reduction of intraoperative fentanyl consumption (p value ˂ 0.001), and delay of the first rescue analgesia (p value ˂ 0.001) were recorded in SF group in relation to F group without significant complications in both groups.
CONCLUSIONS


Serratus anterior plane block can provide a safe, effective, and easy-to-perform regional technique for children undergoing thoracotomies.",2022,"In addition, significant decreases of the postoperative FLACC pain score (p value ˂ 0.001), reduction of intraoperative fentanyl consumption (p value ˂ 0.001), and delay of the first rescue analgesia (p value ˂ 0.001) were recorded in SF group in relation to F group without significant complications in both groups.
","['pediatric patients', 'Undergoing Thoracic Surgeries', 'children undergoing thoracotomies', 'Seventy pediatric patients aged six months-to-three years scheduled for thoracotomies', 'Pediatric Patients', 'A single-center study at Aboelrish Pediatric Hospital, one tertiary hospital of Cairo University Hospitals']","['serratus anterior plane block (SAPB', 'intraoperative fentanyl infusion', 'SF and group F. Group SF received an ultrasound-guided SAPB']","['delay of the first rescue analgesia', 'total dose of postoperatively administrated fentanyl', 'postoperative FLACC pain score', 'efficacy and safety', 'reduction of intraoperative fentanyl consumption', 'total dose of intraoperative additional fentanyl boluses; time of the first postoperative rescue analgesia; and postoperative Face, Legs, Activity, Cry, Consolability scale (FLACC) score values']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",70.0,0.718703,"In addition, significant decreases of the postoperative FLACC pain score (p value ˂ 0.001), reduction of intraoperative fentanyl consumption (p value ˂ 0.001), and delay of the first rescue analgesia (p value ˂ 0.001) were recorded in SF group in relation to F group without significant complications in both groups.
","[{'ForeName': 'Ahmed Ali', 'Initials': 'AA', 'LastName': 'Gado', 'Affiliation': 'Anesthesia and Pain Management, Department of Anesthesia, Kasr Alainy Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdalwahab', 'Affiliation': 'Anesthesia and Pain Management, Department of Anesthesia, Kasr Alainy Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Anesthesia and Pain Management, Department of Anesthesia, Kasr Alainy Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Wafaa Mohamed', 'Initials': 'WM', 'LastName': 'Alsadek', 'Affiliation': 'Anesthesia and Pain Management, Department of Anesthesia, Kasr Alainy Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Ahmed Abdelaziz', 'Initials': 'AA', 'LastName': 'Ismail', 'Affiliation': 'Anesthesia and Pain Management, Department of Anesthesia, Kasr Alainy Faculty of Medicine, Cairo University, Egypt. Electronic address: ahmed.abdelaziz81@yahoo.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.09.014']
240,34612802,Pilot clinical trial of a clinical meditation and imagery intervention for chronic pain after spinal cord injury.,"OBJECTIVE


To assess the feasibility and potential benefits of clinical meditation and imagery (CMI) for people with chronic spinal cord injury (SCI) and chronic pain.
DESIGN


Pilot randomized, controlled trial.
SETTING


Outpatients with SCI in the United States.
PARTICIPANTS


24 adults with chronic SCI (>1 year) and a >3 month history of pain rated ≥4/10 on average over the last week.
INTERVENTIONS


4-week program of once-weekly 2-hour group classes, offered in-person and online. CMI group participants were taught mindfulness, mantra meditation, and guided imagery practices. Control group participants received education on topics related to health and function after SCI.
OUTCOME MEASURES


Pain interference (primary outcome), pain cognitions, pain intensity/unpleasantness, depressive symptomology, perceived stress.
RESULTS


Pain interference decreased to a greater extent in the control group at both Day 42 and Day 70, with a large effect size (d > 1.0). Several secondary outcome measures showed changes consistent with more favorable outcomes in the CMI group at both Day 42 and Day 70, with a large effect size d > 0.80, including worst pain intensity over the last week, depressive symptomology, belief in pain as a sign of harm and perceived control over pain. Perceived stress improved to a greater extent in the control group (d = 1.16 at Day 42, d = .20 at Day 70).
CONCLUSION


CMI is feasible and acceptable to implement with people with SCI and chronic pain. Further study is warranted to assess potential benefits for pain-related outcomes.",2022,"Perceived stress improved to a greater extent in the control group (d = 1.16 at Day 42, d = .20 at Day 70).
","['24 adults with chronic SCI (>1 year) and a >3 month history of pain rated ≥4/10 on average over the last week', 'Outpatients with SCI in the United States', 'people with chronic spinal cord injury (SCI) and chronic pain', 'chronic pain after spinal cord injury']","['clinical meditation and imagery (CMI', 'clinical meditation and imagery intervention', 'CMI']","['Pain interference (primary outcome), pain cognitions, pain intensity/unpleasantness, depressive symptomology, perceived stress', 'depressive symptomology, belief in pain as a sign of harm and perceived control over pain', 'Perceived stress', 'Pain interference', 'worst pain intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",24.0,0.249255,"Perceived stress improved to a greater extent in the control group (d = 1.16 at Day 42, d = .20 at Day 70).
","[{'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Zanca', 'Affiliation': 'Center for Spinal Cord Injury Research, Kessler Foundation, West Orange, New Jersey, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gilchrist', 'Affiliation': 'Department of Integrative Medicine, Mount Sinai Beth Israel, New York, New York, USA.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Ortiz', 'Affiliation': 'Department of Integrative Medicine, Mount Sinai Beth Israel, New York, New York, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Center for Spinal Cord Injury Research, Kessler Foundation, West Orange, New Jersey, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2021.1970894']
241,34634968,Durability of no evidence of disease activity-3 (NEDA-3) in patients receiving cladribine tablets: The CLARITY extension study.,"BACKGROUND


No evidence of disease activity (NEDA-3) is a patient-centric outcome increasingly used as the goal of multiple sclerosis treatment.
OBJECTIVE


Determine treatment durability of cladribine tablets beyond 2 years considering the variable bridging interval of 0.1-116.0 weeks between CLARITY and CLARITY Extension.
METHODS


Between CLARITY and CLARITY Extension, patients transitioned from cladribine tablets 3.5 mg/kg to placebo (CP3.5 group,  n  = 98) or continued further treatment with cladribine tablets 3.5 mg/kg (CC7.0 group,  n  = 186). Treatment assignment was randomized and blinded in both CLARITY and CLARITY Extension.
RESULTS


The 2-year NEDA-3 in CLARITY Extension (encompassing both years of CLARITY Extension) was 29.6% in the CP3.5 group and 32.8% in the CC7.0 group. There was no evidence that treatment effect differed with varying bridging intervals. For patients in the CP3.5 group with a bridging interval of ⩽48 weeks, 1 year NEDA-3 (the first year of CLARITY Extension) was 44.4% (28/63) compared with 31.4% (11/35) in patients with a bridging interval of >48 weeks.
CONCLUSION


Treatment with cladribine tablets in CLARITY, followed by either placebo or cladribine tablets in CLARITY Extension, produced sustained benefits for NEDA-3 and its constituent elements for a follow up period up to 6 years from CLARITY baseline.",2022,There was no evidence that treatment effect differed with varying bridging intervals.,['patients receiving cladribine tablets'],"['placebo or cladribine', 'cladribine', 'cladribine tablets', 'placebo', 'cladribine tablets 3.5\u2009mg/kg (CC7.0']",['2-year NEDA-3 in CLARITY Extension'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",,0.253006,There was no evidence that treatment effect differed with varying bridging intervals.,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Singer', 'Affiliation': 'The MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Issard', 'Affiliation': 'Department of Biostatistics, Cytel Inc., Geneva, Switzerland.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Jack', 'Affiliation': 'Global Medical Affairs, Neurology and Immunology, Merck Serono Ltd, Feltham, UK (an affiliate of Merck KGaA).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'Univ. Lille, Inserm U1172 LilNCog, CHU Lille, FHU Precise, Lille, France.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211049392']
242,34649978,Randomised trial of the P2X 3  receptor antagonist sivopixant for refractory chronic cough.,"BACKGROUND


The purinoceptor subtype P2X 3  has been shown to have significant involvement in the cough reflex; the heterotrimer version of the purinoceptor (P2X 2/3 ) has been implicated in taste disturbance. The most advanced clinical candidate antagonist gefapixant has low selectivity among P2X 3  receptors and induced taste disturbance, whereas newly developed sivopixant has high selectivity towards P2X 3   versus  P2X 2/3 .
METHODS


In a phase 2a, randomised, double-blind, placebo-controlled, crossover, multicentre study, adult patients with refractory or unexplained chronic cough received oral sivopixant 150 mg or placebo once daily for 2 weeks, followed by a 2-3-week washout period, and then crossed over to placebo or sivopixant for 2 weeks. Efficacy and safety of sivopixant were evaluated.
RESULTS


Of 31 randomised patients, 15 in the sivopixant-first group and 15 in the placebo-first group completed the study. After 2 weeks of treatment, the placebo-adjusted ratios of the average hourly number of coughs to baseline during daytime (primary end-point) and over 24 h (secondary end-point) were -31.6% (p=0.0546) and -30.9% (p=0.0386), respectively. Sivopixant also improved health-related quality of life. Treatment-related adverse events occurred in 12.9% and 3.2% of patients during sivopixant and placebo administration, respectively. Mild taste disturbance occurred in two patients (6.5%) during sivopixant administration.
CONCLUSIONS


Sivopixant reduced objective cough frequency and improved health-related quality of life, with a low incidence of taste disturbance, among patients with refractory or unexplained chronic cough.",2022,"Treatment-related adverse events occurred in 12.9% and 3.2% of patients during sivopixant and placebo administration, respectively.","['refractory chronic cough', 'adult patients with refractory or unexplained chronic cough received', 'patients with refractory or unexplained chronic cough']","['oral sivopixant 150\u2005mg or placebo', 'placebo', 'placebo or sivopixant', 'P2X 3  receptor antagonist sivopixant']","['objective cough frequency and improved health-related quality of life', 'Mild taste disturbance', 'adverse events', 'health-related quality of life', 'Efficacy and safety of sivopixant']","[{'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.413989,"Treatment-related adverse events occurred in 12.9% and 3.2% of patients during sivopixant and placebo administration, respectively.","[{'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Niimi', 'Affiliation': 'Dept of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University, Nagoya, Japan.'}, {'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Saito', 'Affiliation': 'Dept of Pulmonary Medicine, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kamei', 'Affiliation': 'Dept of Respiratory Medicine, Kamei Internal Medicine and Respiratory Clinic, Kagawa, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Shinkai', 'Affiliation': 'Dept of Respiratory Medicine, Tokyo Shinagawa Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ishihara', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Machida', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Miyazaki', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan sayaka.miyazaki@shionogi.co.jp.'}]",The European respiratory journal,['10.1183/13993003.00725-2021']
243,34670042,"A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH.","BACKGROUND


Management of nonalcoholic steatohepatitis (NASH) is an unmet clinical need. Lanifibranor is a pan-PPAR (peroxisome proliferator-activated receptor) agonist that modulates key metabolic, inflammatory, and fibrogenic pathways in the pathogenesis of NASH.
METHODS


In this phase 2b, double-blind, randomized, placebo-controlled trial, patients with noncirrhotic, highly active NASH were randomly assigned in a 1:1:1 ratio to receive 1200 mg or 800 mg of lanifibranor or placebo once daily for 24 weeks. The primary end point was a decrease of at least 2 points in the SAF-A score (the activity part of the Steatosis, Activity, Fibrosis [SAF] scoring system that incorporates scores for ballooning and inflammation) without worsening of fibrosis; SAF-A scores range from 0 to 4, with higher scores indicating more-severe disease activity. Secondary end points included resolution of NASH and regression of fibrosis.
RESULTS


A total of 247 patients underwent randomization, of whom 103 (42%) had type 2 diabetes mellitus and 188 (76%) had significant (moderate) or advanced fibrosis. The percentage of patients who had a decrease of at least 2 points in the SAF-A score without worsening of fibrosis was significantly higher among those who received the 1200-mg dose, but not among those who received the 800-mg dose, of lanifibranor than among those who received placebo (1200-mg dose vs. placebo, 55% vs. 33%, P = 0.007; 800-mg dose vs. placebo, 48% vs. 33%, P = 0.07). The results favored both the 1200-mg and 800-mg doses of lanifibranor over placebo for resolution of NASH without worsening of fibrosis (49% and 39%, respectively, vs. 22%), improvement in fibrosis stage of at least 1 without worsening of NASH (48% and 34%, respectively, vs. 29%), and resolution of NASH plus improvement in fibrosis stage of at least 1 (35% and 25%, respectively, vs. 9%). Liver enzyme levels decreased and the levels of the majority of lipid, inflammatory, and fibrosis biomarkers improved in the lanifibranor groups. The dropout rate for adverse events was less than 5% and was similar across the trial groups. Diarrhea, nausea, peripheral edema, anemia, and weight gain occurred more frequently with lanifibranor than with placebo.
CONCLUSIONS


In this phase 2b trial involving patients with active NASH, the percentage of patients who had a decrease of at least 2 points in the SAF-A score without worsening of fibrosis was significantly higher with the 1200-mg dose of lanifibranor than with placebo. These findings support further assessment of lanifibranor in phase 3 trials. (Funded by Inventiva Pharma; NATIVE ClinicalTrials.gov number, NCT03008070.).",2021,"Diarrhea, nausea, peripheral edema, anemia, and weight gain occurred more frequently with lanifibranor than with placebo.
","['patients with noncirrhotic, highly active NASH', '247 patients underwent randomization, of whom 103 (42%) had type 2 diabetes mellitus and 188 (76%) had significant (moderate) or advanced fibrosis']","['placebo', 'lanifibranor or placebo', 'nonalcoholic steatohepatitis (NASH']","['levels of the majority of lipid, inflammatory, and fibrosis biomarkers', 'resolution of NASH without worsening of fibrosis', 'fibrosis stage', 'SAF-A score without worsening of fibrosis', 'resolution of NASH and regression of fibrosis', 'Diarrhea, nausea, peripheral edema, anemia, and weight gain', 'dropout rate for adverse events', 'resolution of NASH plus improvement in fibrosis stage', 'SAF-A score (the activity part of the Steatosis, Activity, Fibrosis [SAF] scoring system that incorporates scores for ballooning and inflammation) without worsening of fibrosis; SAF-A scores range', 'severe disease activity', 'Liver enzyme levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5139734', 'cui_str': 'lanifibranor'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0174878', 'cui_str': 'Syntex adjuvant formulation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}]",247.0,0.32788,"Diarrhea, nausea, peripheral edema, anemia, and weight gain occurred more frequently with lanifibranor than with placebo.
","[{'ForeName': 'Sven M', 'Initials': 'SM', 'LastName': 'Francque', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bedossa', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Bugianesi', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Rozalina', 'Initials': 'R', 'LastName': 'Balabanska', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Lyudmila', 'Initials': 'L', 'LastName': 'Mateva', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lanthier', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Jörn M', 'Initials': 'JM', 'LastName': 'Schattenberg', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Stefanova-Petrova', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Vonghia', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Régine', 'Initials': 'R', 'LastName': 'Rouzier', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Guillaume', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hodge', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Romero-Gómez', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Huot-Marchand', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Baudin', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Marie-Paule', 'Initials': 'MP', 'LastName': 'Richard', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Abitbol', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Broqua', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Junien', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d\'Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels - all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P. Bedossa, Q.M.A.); Pitie-Salpétriêre Hospital, Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris (V.R.), Centre Hospitalier Universitaire Rangueil, Toulouse (M.G.), and Inventiva Pharma, Daix (P.H.-M., M.B., M.-P.R., J.-L.A., P. Broqua, J.-L.J.) - all in France; the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); Virginia Commonwealth University, Richmond (A.J.S.); the University of California San Diego, La Jolla (R.L.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); Acibadem City Clinic Tokuda Hospital (R.B.), University Hospital ""St. Ivan Rilski,"" Medical University-Sofia (L.M.), and Diagnostic Consultation Center Alexandrovska (D.S.-P.) - all in Sofia, Bulgaria; Arizona Liver Health, Phoenix (N.A.); Metabolic Liver Research Program, Department of Medicine, University Medical Center, Mainz, Germany (J.M.S.); Cap Research, Quatre Bornes, Mauritius (R.R.); Monash Medical Centre, Clayton, VIC, Australia (A.H.); Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain (M.R.-G.); and Duke University Medical Center, Durham, NC (M.F.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2036205']
244,34744156,"Effects of Etco2 on the Minimum Alveolar Concentration of Sevoflurane that Blunts the Adrenergic Response to Surgical Incision: A Prospective, Randomized, Double-Blinded Trial.","BACKGROUND


CO2 has anesthetic potency and effectively influences the circulatory system. We investigated the effects of Etco2 on the minimum alveolar concentration of sevoflurane that blunts the adrenergic response to surgical incision (MAC-BAR) in patients undergoing radical surgery for gastric carcinoma.
METHODS


Ninety patients undergoing radical gastric-carcinoma surgery under general anesthesia were enrolled and randomly assigned into 3 groups. After intubation, the Etco2 in group L (n = 30), group N (n = 30), and group H (n = 30) was adjusted to 25 mm Hg ≤ Etco2 <30 mm Hg, 30 mm Hg ≤ Etco2 < 40 mm Hg, and 40 mm Hg ≤ Etco2 < 45 mm Hg, respectively, by changes in controlled ventilation. Hemodynamics and depth of anesthesia were observed before and after skin incision. The MAC-BAR of sevoflurane for each group was determined using an up-and-down sequential-allocation technique.
RESULTS


To obtain 7 crossovers, 25, 26, and 26 patients were used in group L, group N, and group H, respectively. The MAC-BAR of sevoflurane using the up-and-down method for group H was significantly lower than that for group L (2.3% [95% confidence interval {CI}, 2.2-2.4] vs 2.9% [95% CI, 2.7-3.0]; difference, -0.6% [95% CI, -0.7 to -0.4], P < .001) and group N (2.3% [95% CI, 2.2-2.4] vs 2.8% [95% CI, 2.8-2.9]; difference, -0.5% [95% CI, -0.7 to -0.4], P < .001), while no significant difference was found between group L and group N (P = 1.000).
CONCLUSIONS


Higher Etco2 levels (Etco2 values equal to 40 mm Hg or higher) can effectively decrease the MAC-BAR of sevoflurane in patients undergoing radical surgery for gastric carcinoma.",2022,"The MAC-BAR of sevoflurane using the up-and-down method for group H was significantly lower than that for group L (2.3% [95% confidence interval {CI}, 2.2-2.4] vs 2.9% [95% CI, 2.7-3.0]; difference, -0.6% [95% CI, -0.7 to -0.4], P < .001) and group N (2.3% [95% CI, 2.2-2.4] vs 2.8% [95% CI, 2.8-2.9]; difference, -0.5% [95% CI, -0.7 to -0.4], P < .001), while no significant difference was found between group L and group N (P = 1.000).
","['patients undergoing radical surgery for gastric carcinoma', 'Ninety patients undergoing radical gastric-carcinoma surgery under general anesthesia']","['Sevoflurane', 'surgical incision (MAC-BAR', 'sevoflurane']","['MAC-BAR', 'Hemodynamics and depth of anesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0699791', 'cui_str': 'Carcinoma of stomach'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0474710', 'cui_str': 'Depth of anesthesia'}]",90.0,0.220499,"The MAC-BAR of sevoflurane using the up-and-down method for group H was significantly lower than that for group L (2.3% [95% confidence interval {CI}, 2.2-2.4] vs 2.9% [95% CI, 2.7-3.0]; difference, -0.6% [95% CI, -0.7 to -0.4], P < .001) and group N (2.3% [95% CI, 2.2-2.4] vs 2.8% [95% CI, 2.8-2.9]; difference, -0.5% [95% CI, -0.7 to -0.4], P < .001), while no significant difference was found between group L and group N (P = 1.000).
","[{'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Tianhua', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Huiting', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Wenqian', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Longhui', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'From the Department of Anesthesiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005784']
245,34706980,Randomised controlled trial to investigate the use of high-frequency airway oscillations as  t raining to  i mprove  d yspno e a (TIDe) in COPD.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is characterised by symptomatic dyspnoea and reduced exercise tolerance, in part as a result muscle weakness, for which inspiratory muscle training (IMT) may be useful. Excess mucus hypersecretion commonly coexists in COPD and may lead to reduce ventilation, further impacting on breathlessness. Devices for sputum clearance may be employed to aid mucus expectoration. This trial aimed to explore the effectiveness of a combined IMT and high-frequency airway oscillating (HFAO) device in the management of dyspnoea.
METHODS


This was a double-blinded, randomised sham-controlled trial which recruited symptomatic patients with COPD. Patients were randomised to either a HFAO device (Aerosure) or sham device for 8 weeks, three times a day. The primary outcome was the Chronic Respiratory Questionnaire dyspnoea (CRQ-D) domain. Pre-specified subgroup analyses were performed including those with respiratory muscle weakness, excessive sputum and frequent exacerbators.
RESULTS


104 participants (68% men, mean (SD) age 69.75 years (7.41), forced expiratory volume in 1 s per cent predicted 48.22% (18.75)) were recruited to this study with 96 participants completing. No difference in CRQ-D was seen between groups (0·28, 95% CI -0.19 to 0.75, p=0.24), though meaningful improvements were seen over time in both groups (mean (SD) HFAO 0.45 (0.78), p<0.01; sham 0.73 (1.09), p<0.01). Maximal inspiratory pressure significantly improved in the HFAO group over sham (5.26, 95% CI 0.34 to 10.19, p=0.05). Similar patterns were seen in the subgroup analysis.
CONCLUSION


There were no statistical differences between the HFAO and the sham group in improving dyspnoea measured by the CRQ-D.
TRIAL REGISTRATION NUMBER


ISRCTN45695543.",2022,"There were no statistical differences between the HFAO and the sham group in improving dyspnoea measured by the CRQ-D.
TRIAL REGISTRATION NUMBER


ISRCTN45695543.","['recruited symptomatic patients with COPD', '104 participants (68% men, mean (SD) age 69.75 years (7.41), forced expiratory volume in 1 s per cent predicted 48.22% (18.75)) were recruited to this study with 96 participants completing', 'Chronic obstructive pulmonary disease (COPD']","['HFAO device (Aerosure) or sham device', 'd yspno', 'combined IMT and high-frequency airway oscillating (HFAO) device', 'HFAO']","['dyspnoea', 'Maximal inspiratory pressure', 'Chronic Respiratory Questionnaire dyspnoea (CRQ-D) domain', 'CRQ-D']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C4517612', 'cui_str': '18.75'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",104.0,0.743715,"There were no statistical differences between the HFAO and the sham group in improving dyspnoea measured by the CRQ-D.
TRIAL REGISTRATION NUMBER


ISRCTN45695543.","[{'ForeName': 'Enya', 'Initials': 'E', 'LastName': 'Daynes', 'Affiliation': 'CERS, NIHR Leicester Biomedical Research Centre, Leicester, East Midlands, UK enya.daynes@uhl-tr.nhs.uk.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Greening', 'Affiliation': 'CERS, NIHR Leicester Biomedical Research Centre, Leicester, East Midlands, UK.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'CERS, NIHR Leicester Biomedical Research Centre, Leicester, East Midlands, UK.'}]",Thorax,['10.1136/thoraxjnl-2021-217072']
246,34724145,Scoring model to predict risk of chronic kidney disease in Chinese health screening examinees with type 2 diabetes.,"PURPOSE


As health screening continues to increase in China, there is an opportunity to integrate a large number of demographic as well as subjective and objective clinical data into risk prediction modeling. The aim of this study was to develop and validate a prediction model for chronic kidney disease (CKD) in Chinese health screening examinees with type 2 diabetes mellitus (T2DM).
METHODS


We conducted a retrospective cohort study consisting of 2051 Chinese T2DM patients between 35 and 78 years old who were enrolled in the XY3CKD Follow-up Program between 2009 and 2010. All participants were randomly assigned into a derivation set or a validation set at a 2:1 ratio. Cox proportional hazards regression model was selected for the analysis of risk factors for the development of the proposed risk model of CKD. We established a prediction model with a scoring system following the steps proposed by the Framingham Heart Study.
RESULTS


The mean follow-up was 8.52 years, with a total of 315 (23.20%) and 189 (27.27%) incident CKD cases in the derivation set and validation set, respectively. We identified the following risk factors: age, gender, body mass index, duration of type 2 diabetes, variation of fasting blood glucose, stroke, and hypertension. The points were summed to obtain individual scores (from 0 to 15). The areas under the curve of 3-, 5- and 10-year CKD risks were 0.843, 0.799 and 0.780 in the derivation set and 0.871, 0.803 and 0.785 in the validation set, respectively.
CONCLUSIONS


The proposed scoring system is a promising tool for further application of assisting Chinese medical staff for early prevention of T2DM complications among health screening examinees.",2022,The proposed scoring system is a promising tool for further application of assisting Chinese medical staff for early prevention of T2DM complications among health screening examinees.,"['2051 Chinese T2DM patients between 35 and 78\xa0years old who were enrolled in the XY3CKD Follow-up Program between 2009 and 2010', 'Chinese health screening examinees with type 2 diabetes', 'Chinese health screening examinees with type 2 diabetes mellitus (T2DM']",[],['10-year CKD risks'],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0220908', 'cui_str': 'Screening procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2051.0,0.0250725,The proposed scoring system is a promising tool for further application of assisting Chinese medical staff for early prevention of T2DM complications among health screening examinees.,"[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Health Management, Health Management Research Center of Central South University, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan Province, China.'}, {'ForeName': 'Binfang', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Health Management, Health Management Research Center of Central South University, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan Province, China.'}, {'ForeName': 'Jiansong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychiatry & Mental Health Institute, The Second Xiangya Hospital, Central South University, Changsha, Hunan Province, China. jasonzhou75@163.com.'}]",International urology and nephrology,['10.1007/s11255-021-03045-9']
247,34726542,Primary Care Physician Adherence to Telepsychiatry Recommendations: Intermediate Outcomes from a Randomized Clinical Trial.,"Objective:   To compare clinical recommendations given by psychiatrists and the adherence to these recommendations by primary care physicians (PCP) following consultations conducted by asynchronous telepsychiatry (ATP) and synchronous telepsychiatry (STP).   Materials and Methods:   ATP and STP consultations were compared using intermediate data from a randomized clinical trial with adult participant enrollment between April 2014 and December 2017. In both study arms, PCPs received written recommendations from the psychiatrist after each encounter. Independent clinicians reviewed PCP documentation to measure adherence to those recommendations in the 6 months following the baseline consultation.   Results:   Medical records were reviewed for 645 psychiatrists' consult recommendations; 344 from 61 ATP consultations and 301 from 62 STP consultations. Of those recommendations, 191 (56%) and 173 (58%) were rated fully adherent by two independent raters for ATP and STP, respectively. In a multilevel ordinal logistic regression model adjusted for recommendation type and recommended implementation timing, there was no statistically significant difference in adherence to recommendations for ATP compared with STP (adjusted odds ratio = 0.91, 95% confidence interval = 0.51-1.62). The profiles of recommendation type were comparable between ATP and STP.   Conclusions:   This is the first PCP adherence study comparing two forms of telemedicine. Although we did not find evidence of a difference between ATP and STP; this study supports the feasibility and acceptability of ATP and STP for the provision of collaborative psychiatric care. Clinical Trial Identifier NCT02084979 .",2022,"In a multilevel ordinal logistic regression model adjusted for recommendation type and recommended implementation timing, there was no statistically significant difference in adherence to recommendations for ATP compared with STP (adjusted odds ratio = 0.91, 95% confidence interval = 0.51-1.62).","[""Results:  Medical records were reviewed for 645 psychiatrists' consult recommendations; 344 from 61 ATP consultations and 301 from 62 STP consultations"", 'adult participant enrollment between April 2014 and December 2017']","['Telepsychiatry Recommendations', 'asynchronous telepsychiatry (ATP) and synchronous telepsychiatry (STP']",[],"[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}]",[],,0.238869,"In a multilevel ordinal logistic regression model adjusted for recommendation type and recommended implementation timing, there was no statistically significant difference in adherence to recommendations for ATP compared with STP (adjusted odds ratio = 0.91, 95% confidence interval = 0.51-1.62).","[{'ForeName': 'Monica K', 'Initials': 'MK', 'LastName': 'Lieng', 'Affiliation': 'Department of Pediatrics, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Magi S', 'Initials': 'MS', 'LastName': 'Aurora', 'Affiliation': 'Department of Psychiatry, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'School of Medicine, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Marcin', 'Affiliation': 'Department of Pediatrics, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Mouzoon', 'Affiliation': 'Department of Pediatrics, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Department of Pediatrics, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Parish', 'Affiliation': 'Department of Psychiatry, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Alvaro D', 'Initials': 'AD', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Psychiatry, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Lorin', 'Initials': 'L', 'LastName': 'Scher', 'Affiliation': 'Department of Psychiatry, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Xiong', 'Affiliation': 'Department of Psychiatry, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'McCarron', 'Affiliation': 'School of Medicine, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Yellowlees', 'Affiliation': 'Department of Psychiatry, Center for Health and Technology, University of California Davis Health, Sacramento, California, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2021.0389']
248,34750670,Local vancomycin therapy to reduce surgical site infection in adult spine surgery: a randomized prospective study.,"PURPOSE


This prospective randomized controlled trial hypothesizes that intra wound vancomycin reduces postoperative infection.
METHODS


In this RCT study, the patients were randomly divided into two groups of treatment and control. In the treatment group, 1-2 g of intra wound vancomycin was used, and no drug was used for the control group. SSI and the type of microorganism causing postoperative infection were assessed at a three-month follow-up. Factors affecting postoperative infection such as age, sex, site of operation, surgical levels, and risk factors affecting postoperative infection, such as diabetes, blood pressure, ischemic heart disease, smoking, blood transfusion, BMI, neurologic deficit, CSF leakage, UTI, COPD and surgery time were examined in two groups.
RESULTS


In this study, 375 patients, including 187patients in the treatment group and 188 patients in the control group, were studied. Among the patients, 228 had surgery without instrumentation, and 147 had surgery with instrumentation. There were 12 cases of SSI in the treatment group and 11 in the control group, and there was no statistically significant difference between the two groups. There was no difference between the two groups with and without instrumentation in the evaluation of postoperative infection. In the subgroups with and without instruments, there was no significant difference between treatment and control groups. Due to the microorganism causing the infection, gram-negative bacteria were more common in the treatment group.
CONCLUSION


Intra-wound vancomycin has no effect on SSI; in addition, it can increase the rate of gram-negative infections.",2022,There was no difference between the two groups with and without instrumentation in the evaluation of postoperative infection.,"['adult\xa0spine surgery', '375 patients, including 187patients in the treatment group and 188 patients in the control group, were studied', 'patients, 228 had surgery without instrumentation, and 147 had surgery with instrumentation']","['Local vancomycin therapy', 'vancomycin']","['SSI', 'surgical site infection', 'diabetes, blood pressure, ischemic heart disease, smoking, blood transfusion, BMI, neurologic deficit, CSF leakage, UTI, COPD and surgery time', 'postoperative infection', 'rate of gram-negative infections']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0023182', 'cui_str': 'Cerebrospinal fluid leak'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",375.0,0.0398058,There was no difference between the two groups with and without instrumentation in the evaluation of postoperative infection.,"[{'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Salimi', 'Affiliation': 'Clinical Research and Development Unit, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Khayat Kashani', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran. hrkhka@gmail.com.'}, {'ForeName': 'Shirzad', 'Initials': 'S', 'LastName': 'Azhari', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Sheikhghomy', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.'}, {'ForeName': 'Poorya', 'Initials': 'P', 'LastName': 'Paryan', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'KhayatKashani', 'Affiliation': 'Clinical Research and Development Unit, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-021-07050-5']
249,34726114,"Acute  L -glutamine supplementation does not improve gastrointestinal permeability, injury or microbial translocation in response to exhaustive high intensity exertional-heat stress.","ABSTRACT Purpose:  Exertional-heat stress adversely distrupts (GI) barrier integrity and, through subsequent microbial translocation (MT), can result in potentially fatal exertional-heat stroke. Acute glutamine (GLN) supplementation is a potential nutritional countermeasure, although the practical value of current supplementation regimens is questionable. Method:  Ten males completed two high-intensity exertional-heat stress tests (EHST) involving running in the heat (40°C and 40% relative humidity) at lactate threshold to volitional exhaustion. Participants ingested GLN (0.3 g kg FFM -1 ) or a non-calorific placebo (PLA) one hour prior to the EHST. Venous blood was drawn pre-, post- and one-hour post-EHST. GI permeability was assessed using a serum dual-sugar absorption test (DSAT) and small intestinal epithelial injury using plasma Intestinal Fatty-Acid Binding Protein (I-FABP). MT was assessed using the  Bacteroides /total 16S DNA ratio. Results:  Volitional exhaustion occurred after 22:19 ± 2:22 (minutes: seconds) in both conditions, during which whole-body physiological responses and GI symptoms were not different ( p  > 0.05). GI permeability (serum DSAT) was greater following GLN (0.043 ± 0.020) than PLA (0.034 ± 0.019) ( p  = 0.02;  d  = 0.47), but small intestine epithelial injury (I-FABP) increased comparably ( p  = 0.22;  η p 2    = 0.16 ) following the EHST in both trials (GLN Δ = 1.25 ± 0.63 ng ml -1 ; PLA Δ = 0.92 ± 0.44 ng ml -1 ). GI MT ( Bacteroides /total 16S DNA ratio) was unchanged in either condition following the EHST ( p  = 0.43). Conclusion:  Acute low-dose (0.3 g kg -1  fat free mass) GLN supplementation ingested one hour before high-intesity exertional-heat stress worsened GI permeability, but did not influence either small intestinal epithilial injury or microbial translocation. Abbreviations:  ANOVA: Analysis of variance; CV: Coefficient of Variation; DSAT: Dual Sugar Absorption Test; EDTA: Ethylenediaminetetraacetic acid; EHST: Exertional Heat Stress Test; ELISA: Enzyme Linked Immunosorbent Assay; FFM: Fat Free Mass; GI: Gastrointestinal; GFR: Glomerular Filtration Rate; GLN: Glutamine; HPLC: High Performance Liquid Chromatography; HR: Heart Rate; I-FABP: Intestinal Fatty-Acid Binding Protein; ISAK: International Society for the Advancement of Anthropometric Kinanthropometry; L/R: Lactulose-to-Rhamnose; LT: Lactate Threshold; MT: Microbial Translocation; mVAS: Modified Visual Analogue Scale; PBS: Phosphate-Buffered Saline; PLA: Placebo; qPCR: Quantitative Polymerase Chain Reaction; RH: Relative Humidity; RPE: Rate of Perceived Exertion; SD: Standard Deviation; SEM: Sensor Electronics Module; T core : Core Body Temperature; T body : Mean Body Temperature; T skin : Mean Skin Temperature; TS: Thermal Sensation; V̇O 2max : Maximal Oxygen Uptake. Highlights  The pathophysiology of exertional-heat stroke is widely hypothesised to be at least in part attributable to a systemic inflammatory response caused by the leak of gastrointestinal microbes into the circulating blood.Acute high-dose (0.9 g kg FFM -1 )  L -glutamine supplementation is widely promoted as a practical strategy to protect gastrointestinal barrier integrity during exertional-heat stress. However, previously validated doses are often poorly tolerated and cannot be recommended for widespread implementation.This study examined the efficacy of low-dose (0.30 g kg FFM -1 ; ∼20 grams) acute  L -glutamine supplementation on small intestinal injury, permeability, and microbial translocation in response a high-intensity exertional-heat stress test to exhaustion (20-30 min). This type of exercise accounts for the majority of exertional-heat stroke cases in the military.Despite being universally well-tolerated across all participants, acute low-dose  L -glutamine supplementation worsened gastrointestinal permeability, without influencing either small intestinal injury or microbial translocation. These findings do not support the application of low-dose  L -glutamine supplementation to help prevent exertional-heat stroke.",2021,"GI permeability (serum DSAT) was greater following GLN (0.043 ± 0.020) than PLA (0.034 ± 0.019) ( p  = 0.02;  d  = 0.47), but small intestine epithelial injury (I-FABP) increased comparably ( p  = 0.22; η 2 p = 0.16 ) following the EHST in both trials (GLN Δ = 1.25 ± 0.63 ng·ml -1 ; PLA Δ= 0.92 ± 0.44 ng·ml -1 ).",['Method:  Ten males completed two high-intensity exertional-heat stress tests (EHST) involving running in the heat (40°C and 40% relative humidity) at lactate threshold to volitional exhaustion'],"['Acute glutamine (GLN) supplementation', 'GLN (0.3 g·kg·FFM -1 ) or a non-calorific placebo (PLA) one hour prior to the EHST', 'low-dose (0.30 g·kg·FFM -1 ; ∼20 grams) acute  L -glutamine supplementation']","['small intestine epithelial injury', 'body physiological responses and GI symptoms', 'GI permeability', 'Volitional exhaustion', 'serum dual-sugar absorption test (DSAT) and small intestinal epithelial injury using plasma Intestinal Fatty-Acid Binding Protein (I-FABP', 'Venous blood', 'GI MT ( Bacteroides /total 16S DNA ratio', 'small intestinal injury, permeability, and microbial translocation', 'exertional-heat stroke', 'GI permeability (serum DSAT', 'Gastrointestinal Permeability, Injury or Microbial Translocation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0282507', 'cui_str': 'Stress Disorders, Heat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0428696', 'cui_str': 'Relative humidity'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439208', 'cui_str': 'g'}]","[{'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C1173118', 'cui_str': 'FABP2 protein, human'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4544037', 'cui_str': 'Exertional heat stroke'}]",,0.0703704,"GI permeability (serum DSAT) was greater following GLN (0.043 ± 0.020) than PLA (0.034 ± 0.019) ( p  = 0.02;  d  = 0.47), but small intestine epithelial injury (I-FABP) increased comparably ( p  = 0.22; η 2 p = 0.16 ) following the EHST in both trials (GLN Δ = 1.25 ± 0.63 ng·ml -1 ; PLA Δ= 0.92 ± 0.44 ng·ml -1 ).","[{'ForeName': 'Henry B', 'Initials': 'HB', 'LastName': 'Ogden', 'Affiliation': 'School of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth, UK.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Fallowfield', 'Affiliation': 'Institute of Naval Medicine, Alverstoke, UK.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Child', 'Affiliation': 'School of Chemical Engineering, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Davison', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham Maritime, UK.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Fleming', 'Affiliation': 'Royal Cornwall NHS trust, Truro, UK.'}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Delves', 'Affiliation': 'Institute of Naval Medicine, Alverstoke, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Millyard', 'Affiliation': 'School of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth, UK.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Westwood', 'Affiliation': 'School of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth, UK.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Layden', 'Affiliation': 'School of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth, UK.'}]",European journal of sport science,['10.1080/17461391.2021.2001575']
250,34724678,Real-Time Ultrasound-Guided Versus Ultrasound-Assisted Spinal Anesthesia in Elderly Patients With Hip Fractures: A Randomized Controlled Trial.,"BACKGROUND


Traditional landmark-guided spinal anesthesia can be challenging in elderly patients with hip fractures. Ultrasound assistance (USAS) and real-time ultrasound guidance (USRTG) techniques can facilitate lumbar neuraxial blocks. However, it remains undetermined which method is optimal for use in elderly patients. This study aimed to evaluate which technique was associated with a higher success rate of spinal anesthesia in elderly patients with hip fractures: USAS or USRTG technique.
METHODS


A total of 114 elderly patients (≥70 years of age) with hip fractures were randomly assigned to receive spinal anesthesia using either the USAS or USRTG technique. The primary outcome was the first-attempt success rate, analyzed using the χ2 test. Secondary outcomes included first-pass success rate, the number of needle attempts and passes, locating time, procedure time, total time, adverse reactions and complications, patient satisfaction, and procedural difficulty score.
RESULTS


The first-attempt success rate (80.7% vs 52.6%; 95% confidence interval [CI], for the difference, 11.6-44.6) and first-pass success rate (63.2% vs 31.6%; 95% CI for the difference, 14.2-49) were both significantly higher in the USAS compared with the USRTG group (both P = .001). The number of attempts (1 [1-1] vs 1 [1-3]; P = .001) and median passes (1 vs 3; P < .001) were both significantly lower in the USAS group than in the USRTG group. The USRTG group had a shorter locating time (175 seconds [129-234 seconds] vs 315 seconds [250-390 seconds]; P < .001) but a longer procedure time (488 seconds [260-972 seconds] vs 200 seconds [127-328 seconds]; P < .001) and total time (694 seconds [421-1133 seconds] vs 540 seconds [432-641 seconds]; P = .036). There were no significant differences between the 2 groups with regard to the adverse reactions and complications. More patients in the USAS group had a high satisfaction score of 3 to 5 (P = .008). Overall, anesthesiologists rated the USRTG group procedure as ""more difficult"" (P = .008).
CONCLUSIONS


In elderly patients with hip fractures, spinal anesthesia with the USRTG technique is not superior to the USAS technique since it has a lower success rate, longer procedure time, lower satisfaction score, and is more difficult to perform. So USAS technique may be more suitable for elderly patients.",2022,"Overall, anesthesiologists rated the USRTG group procedure as ""more difficult"" (P = .008).
","['114 elderly patients (≥70 years of age) with hip fractures', 'Elderly Patients', 'elderly patients with hip fractures', 'With Hip Fractures', 'elderly patients']","['Real-Time Ultrasound-Guided Versus Ultrasound-Assisted Spinal Anesthesia', 'spinal anesthesia using either the USAS or USRTG technique', 'USAS', 'Ultrasound assistance (USAS) and real-time ultrasound guidance (USRTG) techniques', 'spinal anesthesia']","['shorter locating time', 'high satisfaction score', 'number of attempts', 'longer procedure time', 'success rate', 'median passes', 'first-pass success rate, the number of needle attempts and passes, locating time, procedure time, total time, adverse reactions and complications, patient satisfaction, and procedural difficulty score', 'first-attempt success rate', 'first-pass success rate', 'adverse reactions and complications', 'total time']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",114.0,0.145752,"Overall, anesthesiologists rated the USRTG group procedure as ""more difficult"" (P = .008).
","[{'ForeName': 'Luying', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'From the Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'From the Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xinyuan', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.'}, {'ForeName': 'Wuhua', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005778']
251,34727287,Patient adherence and comprehension of take-home anticoagulant regimens prescribed at the emergency department: preliminary findings from a randomized controlled trial and implications for patient safety.,,2022,,[],[],[],[],[],[],,0.321968,,"[{'ForeName': 'Santi', 'Initials': 'S', 'LastName': 'Di Pietro', 'Affiliation': 'Emergency Medicine Unit and Emergency Medicine Postgraduate Training Program, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia, Pavia, Italy. santi.dipietro01@universitadipavia.it.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Ferrari', 'Affiliation': 'Emergency Medicine Unit and Emergency Medicine Postgraduate Training Program, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Re', 'Affiliation': 'Medical Graduate, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Perlini', 'Affiliation': 'Emergency Medicine Unit and Emergency Medicine Postgraduate Training Program, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia, Pavia, Italy.'}]",Internal and emergency medicine,['10.1007/s11739-021-02872-z']
252,34736563,Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease.,"BACKGROUND


There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates.
OBJECTIVES


The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD.
METHODS


The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year.
RESULTS


The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02).
CONCLUSIONS


In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555).",2021,"The difference in all-cause mortality was nonsignificant,","['patients with multivessel CAD', 'multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates', 'Patients With Multivessel Coronary Artery Disease', 'Multivessel CAD candidates', '927 patients were enrolled']","['fractional flow reserve (FFR', 'FFR', 'treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR']","['risk of ischemic cardiovascular events or death', 'composite of major adverse cardiac or cerebrovascular events at 1 year', 'major adverse cardiac or cerebrovascular events rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}]",927.0,0.0588274,"The difference in all-cause mortality was nonsignificant,","[{'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Rioufol', 'Affiliation': 'Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France. Electronic address: gilles.rioufol@univ-lyon1.fr.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dérimay', 'Affiliation': 'Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'Hôpital Arnaud de Villeneuve, Montpellier, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Perret', 'Affiliation': 'Centre Hospitalier Saint Joseph-Saint Luc, Lyon, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Motreff', 'Affiliation': 'Hôpital Gabriel Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Angoulvant', 'Affiliation': 'EA4245 T2i, Hôpital Trousseau, CHRU de Tours, Université de Tours, Tours, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Cottin', 'Affiliation': 'Hôpital du Bocage Central, Dijon, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Meunier', 'Affiliation': 'Centre Hospitalier de La Rochelle, La Rochelle, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cetran', 'Affiliation': 'Hôpital Cardiologique, Centre Hospitalo-Universitaire de Bordeaux, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Service de cardiologie, Hôpital Caremeau, Université de Montpellier, Nîmes, France.'}, {'ForeName': 'Brahim', 'Initials': 'B', 'LastName': 'Harbaoui', 'Affiliation': 'Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Wiedemann', 'Affiliation': 'Centre Hospitalier de Mulhouse, Mulhouse, France.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Van Belle', 'Affiliation': 'Hôpital Cardiologique Calmette, Lille, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pouillot', 'Affiliation': 'Clinique Sainte Clotilde, La Réunion, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Noirclerc', 'Affiliation': 'Centre Hospitalier Annecy-Genevois, Annecy, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Morelle', 'Affiliation': 'Clinique Saint Martin, Caen, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Soto', 'Affiliation': ""Centre Hospitalier d'Auxerre, Auxerre, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caussin', 'Affiliation': 'Institut Mutualiste de Montsouris, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Bertrand', 'Affiliation': 'Hôpital Michallon, Grenoble, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Institut Hospitalier Jacques Cartier, Massy, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dupouy', 'Affiliation': 'Clinique Les Fontaines, Melun, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Lesault', 'Affiliation': ""Hôpital Privé de l'Estuaire, Le Havre, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Albert', 'Affiliation': 'Centre Hospitalier Général, Chartres, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barthelemy', 'Affiliation': 'Hôpital de La Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Koning', 'Affiliation': 'Clinique Saint Hilaire, Rouen, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Leborgne', 'Affiliation': 'Centre Hospitalier Amiens-Picardie, Hôpital Sud, Amiens, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Barnay', 'Affiliation': 'Hôpital Henri Duffaut, Avignon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Chapon', 'Affiliation': 'Centre Hospitalier de Valence, Valence, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Armero', 'Affiliation': 'Hôpital Européen, Marseille, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lafont', 'Affiliation': 'Hôpital Européen George Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Piot', 'Affiliation': 'Clinique Le Millénaire, Montpellier, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Amaz', 'Affiliation': ""Centre d'investigation clinique de Lyon, INSERM 1407, Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Vaz', 'Affiliation': ""Centre d'investigation clinique de Lyon, INSERM 1407, Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Lakhdar', 'Initials': 'L', 'LastName': 'Benyahya', 'Affiliation': ""Centre d'investigation clinique de Lyon, INSERM 1407, Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Varillon', 'Affiliation': ""Centre d'investigation clinique de Lyon, INSERM 1407, Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ovize', 'Affiliation': ""Centre d'investigation clinique de Lyon, INSERM 1407, Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Mewton', 'Affiliation': ""Centre d'investigation clinique de Lyon, INSERM 1407, Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Finet', 'Affiliation': 'Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.08.061']
253,34740596,Skilled Nursing and Inpatient Rehabilitation Facility Use by Medicare Fee-for-Service Beneficiaries Discharged Home After a Stroke: Findings From the COMPASS Trial.,"OBJECTIVES


To examine the effect of a comprehensive transitional care model on the use of skilled nursing facility (SNF) and inpatient rehabilitation facility (IRF) care in the 12 months after acute care discharge home following stroke; and to identify predictors of experiencing a SNF or IRF admission following discharge home after stroke.
DESIGN


Cluster randomized pragmatic trial SETTING: Forty-one acute care hospitals in North Carolina.
PARTICIPANTS


2262 Medicare fee-for-service beneficiaries with transient ischemic attack or stroke discharged home. The sample was 80.3% White and 52.1% female, with a mean (SD) age of 74.9 (10.2) years and a mean ± SD National Institutes of Health stroke scale score of 2.3 (3.7).
INTERVENTION


Comprehensive transitional care model (COMPASS-TC), which consisted of a 2-day follow-up phone call from the postacute care coordinator and 14-day in-person visit with the postacute care coordinator and advanced practice provider.
MAIN OUTCOME MEASURES


Time to first SNF or IRF and SNF or IRF admission (yes/no) in the 12 months following discharge home. All analyses utilized multivariable mixed models including a hospital-specific random effect to account for the non-independence of measures within hospital. Intent to treat analyses using Cox proportional hazards regression assessed the effect of COMPASS-TC on time to SNF/IRF admission. Logistic regression was used to identify clinical and non-clinical predictors of SNF/IRF admission.
RESULTS


Only 34% of patients in the intervention arm received COMPASS-TC per protocol. COMPASS-TC was not associated with a reduced hazard of a SNF/ IRF admission in the 12 months post-discharge (hazard ratio, 1.20, with a range of 0.95-1.52) compared to usual care. This estimate was robust to additional covariate adjustment (hazard ratio, 1.23) (0.93-1.64). Both clinical and non-clinical factors (ie, insurance, geography) were predictors of SNF/IRF use.
CONCLUSIONS


COMPASS-TC was not consistently incorporated into real-world clinical practice. The use of a comprehensive transitional care model for patients discharged home after stroke was not associated with SNF or IRF admissions in a 12-month follow-up period. Non-clinical factors predictive of SNF/IRF use suggest potential issues with access to this type of care.",2022,The use of a comprehensive transitional care model for patients discharged home after stroke was not associated with SNF or IRF admissions in a 12-month follow-up period.,"['The sample was 80.3% White and 52.1% female, with a mean (standard deviation [SD]) age of 74.9 (10.2) years and a mean (SD) NIH stroke scale score of 2.3 (3.7', '2,262 Medicare fee-for-service beneficiaries with transient ischemic attack or stroke discharged home', '41 acute care hospitals in North Carolina', '12 months after acute care discharge home following stroke', 'patients discharged home after stroke was not associated with SNF or IRF admissions in a 12-month follow-up period', 'Beneficiaries s', 'Discharged Home following a Stroke']","['Comprehensive transitional care model (COMPASS-TC) which consisted of a 2-day follow-up phone call from the post-acute care coordinator (PAC) and 14-day in-person visit with the PAC and advanced practice provider', 'skilled nursing facility (SNF) and inpatient rehabilitation facility (IRF) care', 'comprehensive transitional care model', 'COMPASS-TC', 'Skilled Nursing and Inpatient Rehabilitation Facility Use by Medicare Fee-for-Service']","['Time to first SNF or IRF and SNF or IRF admission (yes/no', 'reduced hazard of a SNF/ IRF admission']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0242816', 'cui_str': 'Fees for Service'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C4047962', 'cui_str': 'Admission to inpatient rehabilitation facility'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0376635', 'cui_str': 'Postacute Care'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0242816', 'cui_str': 'Fees for Service'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C4047962', 'cui_str': 'Admission to inpatient rehabilitation facility'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",2262.0,0.0463781,The use of a comprehensive transitional care model for patients discharged home after stroke was not associated with SNF or IRF admissions in a 12-month follow-up period.,"[{'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA. Electronic address: janet_freburger@pitt.edu.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Pastva', 'Affiliation': 'Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Sylvia W', 'Initials': 'SW', 'LastName': 'Coleman', 'Affiliation': 'Department of Neurology, Wake Forest Baptist Health, Medical Center Blvd, Winston-Salem, NC.'}, {'ForeName': 'Kennedy M', 'Initials': 'KM', 'LastName': 'Peter', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kucharska-Newton', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC; Department of Epidemiology, College of Public Health, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Psioda', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology, Wake Forest Baptist Health, Medical Center Blvd, Winston-Salem, NC.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Department of Neurology, Wake Forest Baptist Health, Medical Center Blvd, Winston-Salem, NC.'}, {'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.10.015']
254,34669096,Identification of women at risk of hereditary breast-ovarian cancer among participants in a population-based breast cancer screening.,"Women attending mammography screening may benefit from family history (FH) assessment for the identification of Hereditary Breast Ovarian Cancer (HBOC). Few studies explored the efficacy of tailored educational interventions in driving the attention on FH-associated risk among these women. To compare the efficacy of two educational tools in increasing attention towards FH, 6.802 women with a negative mammography were randomized to receive a note on FH of breast/ovarian cancer (letter A, n = 3.402) or a note with details on possible implication of FH patterns (letter B, n = 3.200). Upon women's request, a brief questionnaire was administered on phone at the Screening Unit (S.U.) to select those eligible for an in-depth FH evaluation at the Genetic Unit (G.U.). Each affected relative was scored 1-3 according to type of cancer, age at diagnosis, gender, position in the family tree. In all, 401 women contacted the S.U.: 244 (6.6%) in group A and 177 (5.2%) in group B (adjOR 1.27; 95%CI 1.03-1.56). FH scored ≥ 3 for 164 women: 177 (47.5%) in group B and 224 (35.7%) in group A, (adjOR 1.59, 95%CI 1.06-2.38). The G.U. traced and interviewed 148 women, 65 (43.9%) were offered an in-person consultation: 38 attended and 30 were eligible for testing. A test was performed for 24 women: no BRCA pathogenic variant was found. Among mammographic screening attendees, educational material with a simple description of FH may improve self-referral of women deserving an in-depth evaluation for HBOC identification. Additional educational efforts are needed to enhance the efficiency of the intervention.",2022,"FH scored ≥ 3 for 164 women: 177 (47.5%) in group B and 224 (35.7%) in group A, (adjOR 1.59, 95%CI 1.06-2.38).","['Women attending', '24 women: no BRCA pathogenic variant was found', 'women at risk of hereditary breast-ovarian cancer among participants in a population-based breast cancer screening', 'The G.U. traced and interviewed 148 women, 65 (43.9%) were offered an in-person consultation: 38 attended and 30 were eligible for testing', '6.802 women with a negative mammography']",['mammography screening'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]","[{'cui': 'C0203028', 'cui_str': 'Screening mammography'}]",[],401.0,0.0832759,"FH scored ≥ 3 for 164 women: 177 (47.5%) in group B and 224 (35.7%) in group A, (adjOR 1.59, 95%CI 1.06-2.38).","[{'ForeName': 'Luigina', 'Initials': 'L', 'LastName': 'Bonelli', 'Affiliation': 'Unit of Clinical Epidemiology, IRCCS Ospedale Policlinico San Martino, Genoa, Italy. luiginaada.bonelli@hsanmartino.it.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Valle', 'Affiliation': 'Department of Prevention, ASL3-Liguria, Genoa, Italy.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Rebora', 'Affiliation': 'Department of Prevention, ASL3-Liguria, Genoa, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Ricci', 'Affiliation': 'Unit of Screening Evaluation and Organization, ASL3-Liguria, Genoa, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Biocchi', 'Affiliation': 'Unit of Screening Evaluation and Organization, ASL3-Liguria, Genoa, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Bruschi', 'Affiliation': 'Unit of Screening Evaluation and Organization, ASL3-Liguria, Genoa, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Parodi', 'Affiliation': 'Unit of Screening Evaluation and Organization, ASL3-Liguria, Genoa, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Bruzzone', 'Affiliation': 'Unit of Hereditary Cancer, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Varesco', 'Affiliation': 'Unit of Hereditary Cancer, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}]",Familial cancer,['10.1007/s10689-021-00281-x']
255,34753654,Impact of High-Frequency Oscillatory Ventilation Combined With Volume Guarantee on Lung Inflammatory Response in Infants With Acute Respiratory Distress Syndrome After Congenital Heart Surgery: A Randomized Controlled Trial.,"OBJECTIVES


Congenital heart disease (CHD) after cardiopulmonary bypass can cause systemic inflammation, and its degree is closely related to the incidence of acute respiratory distress syndrome (ARDS). The purpose of this study was to determine the effectiveness of high-frequency oscillatory ventilation (HFOV) combined with volume guarantee (VG) in reducing systemic inflammation in infants with ARDS after cardiopulmonary bypass for congenital heart surgery.
DESIGN


A randomized controlled trial.
SETTING


Single-center study in a tertiary teaching hospital.
PARTICIPANTS


A total of 58 infants with ARDS after congenital heart surgery were eligible and were randomized to the HFOV (n = 29) or the HFOV-VG (n = 29) between January 2020 and January 2021.
INTERVENTIONS


Tracheal aspirate samples for the measurement of interleukin (IL)-6, IL-8, and tumor necrosis factor-α (TNF-α) were obtained on days one, two, and three of HFOV or HFOV-VG ventilation.
MEASUREMENTS AND MAIN RESULTS


The authors found a significantly increasing trend in the HFOV group mean values of IL-6, IL-8, and TNF-α (p < 0.05 on days two and three v day one), and IL-6, IL-8, and TNF-α levels were significantly higher on day three in the HFOV group versus the HFOV+VG group (p < 0.05). In addition, the incidences of hypocapnia and hypercapnia in infants supported with HFOV-VG were significantly lower (p < 0.05). Furthermore, the postoperative mechanical ventilation duration in the HFOV-VG group also was shorter than that in the HFOV group (p < 0.05).
CONCLUSION


Compared with HFOV alone, HFOV-VG reduced proinflammatory systemic reactions after congenital cardiac surgery, decreased the incidences of hypercapnia and hypocapnia, and shortened the postoperative mechanical ventilation duration.",2022,"Compared with HFOV alone, HFOV-VG reduced proinflammatory systemic reactions after congenital cardiac surgery, decreased the incidences of hypercapnia and hypocapnia, and shortened the postoperative mechanical ventilation duration.","['n = 29) between January 2020 and January 2021', 'Infants With Acute Respiratory Distress Syndrome', 'Single-center study in a tertiary teaching hospital', 'After Congenital Heart Surgery', 'A total of 58 infants with ARDS after congenital heart surgery', 'infants with ARDS after cardiopulmonary bypass for congenital heart surgery']","['HFOV', 'HFOV-VG', 'high-frequency oscillatory ventilation (HFOV) combined with volume guarantee (VG', 'HFOV alone, HFOV-VG', 'High-Frequency Oscillatory Ventilation Combined With Volume Guarantee', 'HFOV+VG']","['IL-6, IL-8, and TNF-α', 'HFOV-VG', 'proinflammatory systemic reactions', 'Lung Inflammatory Response', 'incidences of hypercapnia and hypocapnia, and shortened the postoperative mechanical ventilation duration', 'IL-6, IL-8, and TNF-α levels', 'incidences of hypocapnia and hypercapnia', 'postoperative mechanical ventilation duration']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0085383', 'cui_str': 'Hypocapnia'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",58.0,0.0812455,"Compared with HFOV alone, HFOV-VG reduced proinflammatory systemic reactions after congenital cardiac surgery, decreased the incidences of hypercapnia and hypocapnia, and shortened the postoperative mechanical ventilation duration.","[{'ForeName': 'Yi-Rong', 'Initials': 'YR', 'LastName': 'Zheng', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Wen-Peng', 'Initials': 'WP', 'LastName': 'Xie', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Hong-Lin', 'Initials': 'HL', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiac Surgery, Fujian branch of Shanghai Children's Medical Center, Fuzhou, China; Fujian Children's Hospital, Fuzhou, China; Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Fuzhou, China. Electronic address: chenqiang2228@163.com.""}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.10.012']
256,34758210,Peer-Delivered Cognitive-Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial.,"Objective:  To determine if a 9-week group cognitive-behavioral therapy (CBT) intervention delivered by women who have recovered from postpartum depression (peers) can effectively reduce symptoms of postpartum depression (PPD) and anxiety and improve social support and the mother-infant relationship.
Methods:  A sample of 73 mothers living in Ontario, Canada, were randomized into experimental and waitlist control groups between March 2018 and February 2020. Participants were ≥ 18 years of age, had an infant < 12 months old, were fluent in English, and scored ≥ 10 on the Edinburgh Postnatal Depression Scale. The experimental group completed the 9-week group CBT intervention immediately after study enrollment, while the control group did so after a 9-week waiting period. All outcomes were assessed at enrollment (n = 54) and 9 weeks later (n = 38). Outcomes were assessed in the experimental group at 6 months to assess treatment stability.
Results:  Peer-delivered group CBT for PPD led to clinically and statistically significant improvements in symptoms of depression ( F 1,47  = 22.52,  P  < .01) and anxiety ( F 1,45  = 20.56,  P  < .05) in the experimental group, and these improvements were stable at the 6-month follow-up. Perceptions of impaired mother-infant bonding ( t 15  = 3.72,  P  < .01) and rejection and pathological anger ( t 15  = 3.01,  P  < .01) also decreased at the 6-month follow-up in the experimental group.
Conclusions:  Peer-delivered group CBT for PPD effectively treats symptoms of PPD and anxiety and may lead to improvements in the mother-infant relationship. This intervention is an effective and potentially scalable means by which access to a treatment that meets the needs and wants of mothers with PPD can be increased.
Trial Registration:  ClinicalTrials.gov Identifier: NCT03285139.",2021,"Peer-delivered group CBT for PPD led to clinically and statistically significant improvements in symptoms of depression ( F 1,47  = 22.52,  P  < .01) and anxiety ( F 1,45  = 20.56,  P  < .05) in the experimental group, and these improvements were stable at the 6-month follow-up.","['Postpartum Depression', 'women who have recovered from postpartum depression (peers', '73 mothers living in Ontario, Canada', 'Participants were ≥\u200918 years of age, had an infant\u2009<\u200912 months old, were fluent in English, and scored\u2009≥\u200910 on the Edinburgh Postnatal Depression Scale']","['Peer-Delivered Cognitive-Behavioral Therapy', 'CBT intervention', '9-week group cognitive-behavioral therapy (CBT) intervention']","['anxiety', 'postpartum depression (PPD) and anxiety and improve social support', 'symptoms of depression', 'rejection and pathological anger', 'Perceptions of impaired mother-infant bonding']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",73.0,0.0274937,"Peer-delivered group CBT for PPD led to clinically and statistically significant improvements in symptoms of depression ( F 1,47  = 22.52,  P  < .01) and anxiety ( F 1,45  = 20.56,  P  < .05) in the experimental group, and these improvements were stable at the 6-month follow-up.","[{'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Amani', 'Affiliation': 'Neuroscience Graduate Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Donya', 'Initials': 'D', 'LastName': 'Merza', 'Affiliation': 'Neuroscience Graduate Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Calan', 'Initials': 'C', 'LastName': 'Savoy', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bieling', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario Canada.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ferro', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Van Lieshout', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario Canada.'}]",The Journal of clinical psychiatry,['10.4088/JCP.21m13928']
257,34748653,Crown Accuracy and Time Efficiency of Cement-Retained Implant-Supported Restorations in a Complete Digital Workflow: A Randomized Control Trial.,"PURPOSE


This is a clinical study to compare complete digital workflows generated using intraoral scanning and the split-file technique with a conventional workflow for cement-retained implant-supported restorations.
MATERIALS AND METHODS


Forty patients requiring posterior single-unit implant restorations were included. Twenty patients were randomly assigned to the complete digital workflow group, involving intraoral scanning and manufacture of cement-retained crowns using the split-file technique (test group). The remaining 20 patients were assigned to the hybrid workflow group (control group), involving conventional impressions and CAD-CAM fabricated crowns based on stone casts. Scanning of the crowns was performed before and after clinical adjustment using an intraoral scanner (TRIOS Color; 3Shape). Two 3D digital models were trimmed and superimposed to evaluate changes in dimensions using Geomagic Control 2014 software. Chair-side and laboratory times for the entire workflow were recorded. Independent-sample t tests were used for the statistical analysis.
RESULTS


All crowns were inserted without refabrication. The average maximum occlusal adjustment of the crowns, measured as maximum deviation of occlusal area in superimposed pre and post scans, was -212.7 ± 150.5 and -330.7 ± 192.5 µm in the test and control groups, respectively (p = 0.037). The average area of occlusal adjustment, measured as area of deviation larger than 100 µm, was 8.4 ± 8.1 and 17.1 ± 12.3 mm 2  in the test and control groups, respectively (p = 0.012). The mesial and distal contact adjustment amounts, maximum deviations of proximal area, were -33.0 ± 96.2 and -48.6 ± 70.5 µm in the test group, and -3.7 ± 66.7 µm and -11.4 ± 106.7 µm in the control group, respectively. The mean chair-side time was 20.20 ± 3.00 and 26.65 ± 4.53 minutes in the test and control groups, respectively (p < 0.001). The mean laboratory time was 43.70 ± 5.56 and 84.55 ± 5.81 minutes in the test and control groups, respectively (p < 0.001).
CONCLUSIONS


Single-unit cement-retained crowns with complete digital workflows required fewer crown adjustments and had shorter clinical and laboratory times compared to conventional impressions and hybrid workflows. Digital impressions and the split-file technique provided customized abutments and cement-retained crowns, thus broadening the indications for digital workflows for implants.",2022,"CONCLUSIONS


Single-unit cement-retained crowns with complete digital workflows required fewer crown adjustments and had shorter clinical and laboratory times compared to conventional impressions and hybrid workflows.","['a Complete Digital Workflow', 'Forty patients requiring posterior single-unit implant restorations were included', 'Twenty patients']","['Cement-Retained Implant-Supported Restorations', 'hybrid workflow group (control group), involving conventional impressions and CAD/CAM-fabricated crowns based on stone casts', 'complete digital workflow group, involving intraoral scanning and manufacture of cement-retained crowns using the split-file technique']","['mean chair-side time', 'mesial and distal contact adjustment amounts, maximum deviations of proximal area', 'mean laboratory time', 'maximum deviation of occlusal area']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}]",20.0,0.118068,"CONCLUSIONS


Single-unit cement-retained crowns with complete digital workflows required fewer crown adjustments and had shorter clinical and laboratory times compared to conventional impressions and hybrid workflows.","[{'ForeName': 'Shuxin', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Di', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, China.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13447']
258,34764182,"Nebulised liposomal amphotericin-B as maintenance therapy in allergic bronchopulmonary aspergillosis: a randomised, multicentre trial.","BACKGROUND


In allergic bronchopulmonary aspergillosis (ABPA), prolonged nebulised antifungal treatment may be a strategy for maintaining remission.
METHODS


We performed a randomised, single-blind, clinical trial in 30 centres. Patients with controlled ABPA after 4-month attack treatment (corticosteroids and itraconazole) were randomly assigned to nebulised liposomal amphotericin-B or placebo for 6 months. The primary outcome was occurrence of a first severe clinical exacerbation within 24 months following randomisation. Secondary outcomes included the median time to first severe clinical exacerbation, number of severe clinical exacerbations per patient, ABPA-related biological parameters.
RESULTS


Among 174 enrolled patients with ABPA from March 2015 through July 2017, 139 were controlled after 4-month attack treatment and were randomised. The primary outcome occurred in 33 (50.8%) out of 65 patients in the nebulised liposomal amphotericin-B group and 38 (51.3%) out of 74 in the placebo group (absolute difference -0.6%, 95% CI -16.8- +15.6%; OR 0.98, 95% CI 0.50-1.90; p=0.95). The median (interquartile range) time to first severe clinical exacerbation was longer in the liposomal amphotericin-B group: 337 days (168-476 days)  versus  177 days (64-288 days). At the end of maintenance therapy, total immunoglobulin-E and  Aspergillus  precipitins were significantly decreased in the nebulised liposomal amphotericin-B group.
CONCLUSIONS


In ABPA, maintenance therapy using nebulised liposomal amphotericin-B did not reduce the risk of severe clinical exacerbation. The presence of some positive secondary outcomes creates clinical equipoise for further research.",2022,"At the end of maintenance therapy, total immunoglobulin-E and  Aspergillus  precipitins were significantly decreased in nebulised liposomal-amphotericin-B group.
","['ABPA', 'allergic bronchopulmonary aspergillosis (ABPA', '174 enrolled patients with ABPA from March 2015 through July 2017, 139 were controlled after 4-month attack treatment and were randomised', 'Patients with controlled ABPA after a 4-month attack treatment (corticosteroids and', '30 centres']","['itraconazole', 'Nebulised liposomal-amphotericin-B', 'nebulised liposomal-amphotericin-B or placebo', 'nebulised liposomal-amphotericin', 'nebulised liposomal-amphotericin-B', 'liposomal-amphotericin', 'placebo', 'nebulised liposomal-amphotericin-B group']","['occurrence of a first severe clinical exacerbation', 'median time-to-first severe clinical exacerbation, number of severe clinical exacerbations per patient, ABPA-related biological parameters', 'total immunoglobulin-E and  Aspergillus  precipitins', 'risk of severe clinical exacerbation', 'median time-to-first severe clinical exacerbation']","[{'cui': 'C0004031', 'cui_str': 'Allergic bronchopulmonary aspergillosis'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004031', 'cui_str': 'Allergic bronchopulmonary aspergillosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428539', 'cui_str': 'Total immunoglobulin measurement'}, {'cui': 'C0004034', 'cui_str': 'Aspergillus'}, {'cui': 'C0032936', 'cui_str': 'Precipitins'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",174.0,0.401976,"At the end of maintenance therapy, total immunoglobulin-E and  Aspergillus  precipitins were significantly decreased in nebulised liposomal-amphotericin-B group.
","[{'ForeName': 'Cendrine', 'Initials': 'C', 'LastName': 'Godet', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital Bichat, Service de Pneumologie, Paris, France cendrine.godet@aphp.fr.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Département de Médecine Interne et Pneumologie, EA 3878, CIC INSERM 1412, FCRIN INNOVTE, Brest, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Université François Rabelais, Inserm 1100, Tours, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pison', 'Affiliation': 'CHU Grenoble Alpes, Service Hospitalier Universitaire Pneumologie Physiologie, Pôle Thorax et Vaisseaux, Inserm1055, Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Gagnadoux', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Département de Pneumologie, Angers, France.""}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Blanchard', 'Affiliation': ""CHU Bordeaux site Haut L'évêque, Service des Maladies Respiratoires, Pessac, France.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Taillé', 'Affiliation': 'Groupe Hospitalier Universitaire AP-HP Nord-Université de Paris, Hôpital Bichat, Service de Pneumologie et Centre de Référence Constitutif des Maladies Pulmonaires Rares, Inserm UMR 1152, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Philippe', 'Affiliation': 'Hôpital René Dubos, Service de Pneumologie, Pontoise, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Hirschi', 'Affiliation': 'Hôpitaux Universitaires de Strasbourg, Centre de Compétence des Maladies Pulmonaires Rares, Service de Pneumologie, Strasbourg, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Andréjak', 'Affiliation': 'CHU Amiens Picardie, Service de Pneumologie, UR 4294, Université de Picardie Jules Verne, Amiens, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'Université de Montpellier, CHU Montpellier, PhyMedExp, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Chenivesse', 'Affiliation': ""Service de Pneumologie et Immuno-allergologie, CHU Lille, Centre de Référence Constitutif pour les Maladies Pulmonaires Rares, University Lille, Inserm UMR9017, Institut Pasteur de Lille, CIIL - Centre d'Infection et d'Immunité de Lille, Lille, France, CRISALIS/F-CRIN INSERM network.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dominique', 'Affiliation': 'Rouen University Hospital, Département de Pneumologie, Rouen, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Bassinet', 'Affiliation': 'CHI de Créteil, Service de Pneumologie, Créteil, France.'}, {'ForeName': 'Marlène', 'Initials': 'M', 'LastName': 'Murris-Espin', 'Affiliation': 'CHU de Toulouse, Service de Pneumologie, CRCM Adulte et Transplantation Pulmonaire, Clinique des Voies Respiratoires, Hôpital Larrey, Toulouse, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Rivière', 'Affiliation': ""Hôpital d'Instruction des Armées Percy, Service de Pneumologie, Clamart, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Garcia', 'Affiliation': 'Université Paris-Saclay, School of Medicine, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Caillaud', 'Affiliation': 'CHU Gabriel Montpied, Service de Pneumologie-Allergologie, Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Blanc', 'Affiliation': ""CHU de Nantes, Service de Pneumologie et Centre d'Ivestigations Cliniques Thorax, L'institut du Thorax, Nantes, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Goupil', 'Affiliation': 'CH Le Mans, Service de Pneumologie, Le Mans, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bergeron', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital Saint-Louis, Service de Pneumologie, Université de Paris, Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gondouin', 'Affiliation': 'CHU Besançon, Service de Pneumologie, Besançon, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'CHU Poitiers, Médecine Intensive Réanimation, Inserm, CIC 1402, ALIVE, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Flament', 'Affiliation': 'CHRU de Tours, Service de Pneumologie et Explorations Fonctionnelles Respiratoires, Tours, France.'}, {'ForeName': 'Boubou', 'Initials': 'B', 'LastName': 'Camara', 'Affiliation': 'CHU Grenoble Alpes, Service Hospitalier Universitaire Pneumologie Physiologie, Pôle Thorax et Vaisseaux, Inserm1055, Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pascaline', 'Initials': 'P', 'LastName': 'Priou', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Département de Pneumologie, Angers, France.""}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Brun', 'Affiliation': 'Hôpital Foch, Service de Radiologie, Suresnes, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Laurent', 'Affiliation': 'Université de Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, U1045, CIC 1401, Bordeaux, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': 'INSERM, CIC-1402, Biostatistics, Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital Tenon, Service de Pneumologie et Oncologie Thoracique, Centre Constitutif Maladies Pulmonaires Rares and Sorbonne Université, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Godet', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': ''}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': ''}, {'ForeName': 'A-L', 'Initials': 'AL', 'LastName': 'Brun', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Laurent', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pison', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gagnadoux', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Blanchard', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Taillé', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Philippe', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hirschi', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Andréjak', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chenivesse', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dominique', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bassinet', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Murris-Espin', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivière', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Caillaud', 'Affiliation': ''}, {'ForeName': 'F-X', 'Initials': 'FX', 'LastName': 'Blanc', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Goupil', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gondouin', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Flament', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Camara', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Priou', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.02218-2021']
259,34775413,Functional Outcome of Laparoscopic-Assisted Resection Versus Open Resection of Rectal Cancer: A Secondary Analysis of the Australasian Laparoscopic Cancer of the Rectum Trial.,"BACKGROUND


Low anterior resection syndrome has a significant impact on the quality of life in rectal cancer survivors. Previous studies comparing laparoscopic to open rectal resection have neglected bowel function outcomes.
OBJECTIVE


This study aimed to assess whether there is a difference in the functional outcome between patients undergoing laparoscopic versus open resection for rectal adenocarcinoma.
DESIGN


Cross-sectional prevalence of low anterior resection syndrome was assessed in a secondary analysis of the multicenter phase 3 randomized clinical trial, Australasian Laparoscopic Cancer of the Rectum Trial (ACTRN12609000663257).
SETTING


There were 7 study subsites across New Zealand and Australia.
PATIENTS


Participants were adults with rectal cancer who underwent anterior resection and had bowel continuity.
MAIN OUTCOME MEASURES


Postoperative bowel function was evaluated using the validated low anterior resection syndrome score and Bowel Function Instrument.
RESULTS


The Australasian Laparoscopic Cancer of the Rectum Trial randomized 475 patients with T1-T3 rectal adenocarcinoma less than 15 cm from the anal verge. A total of 257 participants were eligible for, and invited to, participate in additional follow-up; 163 (63%) completed functional follow-up. Overall cross-sectional prevalence of major low anterior resection syndrome was 49% (minor low anterior resection syndrome 27%). There were no differences in median overall Bowel Function Instrument score nor low anterior resection syndrome score between participants undergoing laparoscopic versus open surgery (66 vs 67, p = 0.52; 31 vs 27, p = 0.24) at a median follow-up of 69 months.
LIMITATIONS


The major limitations are a result of conducting a secondary analysis; the likelihood of an insufficient sample size to detect a difference in prevalence between the groups and the possibility of selection bias as a subset of the randomized population was analyzed.
CONCLUSIONS


Bowel dysfunction affects a majority of rectal cancer patients for a significant time after the operation. In this secondary analysis of a randomized trial, surgical approach does not appear to influence the likelihood or severity of low anterior resection syndrome. See Video Abstract at http://links.lww.com/DCR/B794.
RESULTADO FUNCIONAL DE LA RESECCIN ASISTIDA POR LAPAROSCOPIA VERSUS RESECCIN ABIERTA EN CNCER DE RECTO ANLISIS SECUNDARIO DEL ESTUDIO DE CNCER DE RECTO LAPAROSCPICO DE AUSTRALASIA


ANTECEDENTES:El síndrome de resección anterior baja tiene un impacto significativo en la calidad de vida de los supervivientes de cáncer de recto. Los estudios anteriores que compararon la resección rectal laparoscópica con la abierta no han presentado resultados de la función intestinal.OBJETIVO:Evaluar si existe una diferencia en el resultado funcional entre los pacientes sometidos a resección laparoscópica versus resección abierta por adenocarcinoma de recto.DISEÑO:La prevalencia transversal del síndrome de resección anterior baja se evaluó en un análisis secundario del ensayo clínico aleatorizado multicéntrico de fase 3, Estudio Sobre el Cáncer de Recto Laparoscópico de Australasia (Australasian Laparoscopic Cancer of the Rectum Trial, ACTRN12609000663257).AJUSTE:Siete subsitios de estudio en Nueva Zelanda y Australia.PACIENTES:Los participantes eran adultos con cáncer de recto que se sometieron a resección anterior con anastomosis.PRINCIPALES MEDIDAS DE RESULTADO:La función intestinal posoperatoria se evaluó utilizando el previamente validado puntaje LARS y el Instrumento de Función Intestinal.RESULTADOS:El Estudio Sobre el Cáncer de Recto Laparoscópico de Australasia asignó al azar a 475 pacientes con adenocarcinoma rectal T1-T3 a menos de 15 cm del borde anal. 257 participantes fueron elegibles e invitados a participar en un seguimiento adicional. 163 (63%) completaron el seguimiento funcional. La prevalencia transversal general de LARS mayor fue del 49% (LARS menor 27%). No hubo diferencias en la puntuación media general del Instrumento de Función Intestinal ni en la puntuación LARS entre los participantes sometidos a cirugía laparoscópica versus cirugía abierta (66 frente a 67, p = 0,52; 31 frente a 27, p = 0,24) en una mediana de seguimiento de 69 meses.LIMITACIONES:Las principales limitaciones son el resultado de realizar un análisis secundario; se analizó la probabilidad de un tamaño de muestra insuficiente para detectar una diferencia en la prevalencia entre los grupos y la posibilidad de sesgo de selección como un subconjunto de la población aleatorizada.CONCLUSIONES:La disfunción intestinal afecta a la mayoría de los pacientes con cáncer de recto durante un tiempo significativo después de la operación. En este análisis secundario de un ensayo aleatorizado, el abordaje quirúrgico no parece influir en la probabilidad o gravedad del síndrome de resección anterior baja. Consulte Video Resumen en http://links.lww.com/DCR/B794. (Traducción-Dr. Felipe Bellolio).",2022,"There were no differences in median overall Bowel Function Instrument score nor LARS score between participants undergoing laparoscopic vs. open surgery (66 vs 67, p = 0.52; 31 vs 27, p = 0.24) at a median follow-up of 69 months.
","['Rectal Cancer', '475 patients with T1-T3 rectal adenocarcinoma less than 15cm from the anal verge', 'patients undergoing', 'Participants were adults with rectal cancer who underwent anterior resection and had bowel continuity', 'Seven study subsites across New Zealand and Australia', 'rectal cancer patients', 'rectal cancer survivors', '257 participants were eligible for, and invited to, participate in additional follow-up']","['Laparoscopic Assisted Resection vs Open Resection', 'laparoscopic versus open resection', 'laparoscopic to open rectal resection']","['validated LARS score and Bowel Function Instrument', 'median overall Bowel Function Instrument score nor LARS score', 'Overall cross-sectional prevalence of major LARS', 'Postoperative bowel function']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C4517786', 'cui_str': '475'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",475.0,0.569964,"There were no differences in median overall Bowel Function Instrument score nor LARS score between participants undergoing laparoscopic vs. open surgery (66 vs 67, p = 0.52; 31 vs 27, p = 0.24) at a median follow-up of 69 months.
","[{'ForeName': 'Celia R', 'Initials': 'CR', 'LastName': 'Keane', 'Affiliation': 'Department of Surgery, University of Auckland, New Zealand.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Surgery, University of Auckland, New Zealand.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Bissett', 'Affiliation': 'Department of Surgery, University of Auckland, New Zealand.'}, {'ForeName': 'Julian L', 'Initials': 'JL', 'LastName': 'Hayes', 'Affiliation': 'Department of Surgery, Auckland City Hospital, New Zealand.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hulme-Moir', 'Affiliation': 'Department of Surgery, Waitemata District Health Board, New Zealand.'}, {'ForeName': 'Tim W', 'Initials': 'TW', 'LastName': 'Eglinton', 'Affiliation': 'University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Solomon', 'Affiliation': 'Institute of Academic Surgery, Royal Prince Alfred Hospital, University of Sydney, Australia.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Lumley', 'Affiliation': 'Wesley Hospital, Brisbane, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Simes', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre and Sydney Catalyst Translational Research Centre, Sydney, Australia.'}, {'ForeName': 'Andrew R L', 'Initials': 'ARL', 'LastName': 'Stevenson', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Biomedical Sciences, University of Queensland, Australia.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000002166']
260,34779660,"Ex Vivo  Comparison of Efficiency, Safety, and Surgeon Satisfaction in Four Commercial Morcellators.","Introduction:  Holmium laser enucleation of the prostate (HoLEP) is a size-independent treatment option for the management of benign prostatic hypertrophy. Although advancements in laser technology have led to clinical improvements in the enucleation portion of HoLEP, the morcellation aspect of HoLEP is often the rate-limiting step. We sought to compare efficiency and surgeon satisfaction in four commercial morcellators.  Methods:  This was an  ex vivo  study comparing four commercial morcellators: the Wolf Piranha™, the Lumenis VersaCut™, the JenaSurgical MultiCut Solo™, and the Hawk™ Morcellator. Four surgeons with significant experience performing HoLEPs participated. Surgeons tested each device to morcellate two different prostate models (1) morcellating as much microwave-cooked chicken breast in 10 minutes and (2) timed morcellation of bull testicles. Surgeons completed subjective surveys after each morcellator trial. Objective outcomes included the following: morcellation efficiency (g/min morcellated) and aspiration power (time to aspirate 1 L of saline). Means of continuous variables were compared using analysis of variance. Categorical variables were compared using chi-square tests. Statistical analyses were performed using SAS 9.4 (2019).  Results:  Comparing subjective outcomes, the Piranha™ was chosen as the safest morcellator ( p  = 0.0058). The least safe morcellator was thought to be the MultiCut by 75% of surgeons ( p  = 0.046). The Piranha™ was chosen as the most effective morcellator by 75% of surgeons ( p  = 0.046). Comparing objective parameters between the morcellators, the Piranha™ had the fastest aspiration time (43.50 ± 10.34 seconds,  p  = 0.0116). There were no significant differences in morcellation efficiency when using chicken breast ( p  = 0.3096). However, when comparing the morcellation efficiency using bull testicles, the Piranha™ had the highest efficiency at 39.68 ± 3.57 g/min ( p  = 0.0268).  Conclusion:  In this  ex vivo  study comparing four different commercially available morcellators, the Piranha™ had the highest aspiration power. No significant differences were found in morcellation efficiency using microwave-cooked chicken breast. The Piranha™ was felt to be the safest and most effective morcellator.",2022,"Comparing subjective outcomes, the Piranha was chosen as the safest morcellator (p=0.0058).",['Four surgeons with significant experience performing HoLEPs participated'],['Introduction Holmium Laser Enucleation of the Prostate (HoLEP'],"['morcellation efficiency', 'fastest aspiration time', 'efficiency and surgeon satisfaction', 'morcellation efficiency (g/min morcellated) and aspiration power (time to aspirate 1 L of saline', 'efficiency, safety and surgeon satisfaction']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0560021', 'cui_str': 'g/min'}, {'cui': 'C0370199', 'cui_str': 'Specimen obtained by aspiration'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4.0,0.0246041,"Comparing subjective outcomes, the Piranha was chosen as the safest morcellator (p=0.0058).","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Assmus', 'Affiliation': 'Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Lauren F', 'Initials': 'LF', 'LastName': 'Cooley', 'Affiliation': 'Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Large', 'Affiliation': 'Department of Urology, Methodist Hospital, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Krambeck', 'Affiliation': 'Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}]",Journal of endourology,['10.1089/end.2021.0573']
261,34782927,Different timing in allograft and autograft maturation after primary anterior cruciate ligament reconstruction does not influence the clinical outcome at mid-long-term follow-up.,"PURPOSE


The use of allografts in primary anterior cruciate ligament reconstruction (ACLR) is increasing although they are still supposed to be associated to greater risk of re-rupture due to a slower and less efficient graft maturation. The aim of this prospective randomized controlled study was to compare the graft maturation after ACLR with allograft and autograft by MRI at 6- and 12-month follow-up and integrate these data with the functional and clinical results observed at 6-, 12- and 60-month follow-up.
METHODS


Fifty patients with indication to primary ACLR were randomly and equally divided into hamstring autograft or allograft tendon groups. The graft maturation was measured at 6- and 12-month follow-up by the SNQ score and other radiological parameters on MRI scans. Clinical and functional recovery was evaluated by Lysholm score, Visual Analogues Scale, Tegner activity scale and modified Cincinnati knee rating system at 6, 12 and 60 months after surgery to estimate the predictive value of the radiological parameters for clinical outcomes. Return-to-sport (ACL-RSI) was measured 60 months after surgery.
RESULTS


Three patients had retear of the neo-ligament (two from Auto group and one from Allo group). All the clinical/functional parameters significantly improved over time, with no statistically significant difference between the groups. At 6 months, the SNQ value was significantly higher in the Auto than in the Allo group (12.9 vs 7.9, p = 0.038), but at 12 months they were comparable (9.8 vs 10.4). The 6-month SNQ values did not correlate with the clinical scores, whereas the 12-month SNQ values significantly correlated with the Cincinnati score, Lysholm score and Tegner activity scale collected at 60-month follow-up.
CONCLUSION


No clinical or functional differences have been found between the two treatment groups, supporting the suitability of using allograft in primary ACLR, when available. The results at MRI scans showed a different graft maturation trend in the two groups, with allografts being more reactive in the first 6 months. MRI together with the subjective evaluation allows to evaluate objectively the status of the neo-ligamentization process and therefore helps the surgeon to dictate the individual time for return-to-sport.
LEVEL OF EVIDENCE


Level I.",2022,"No clinical or functional differences have been found between the two treatment groups, supporting the suitability of using allograft in primary ACLR, when available.","['Fifty patients with indication to primary ACLR', 'primary anterior cruciate ligament reconstruction (ACLR', 'primary anterior cruciate ligament reconstruction']","['ACLR with allograft and autograft by MRI', 'hamstring autograft or allograft tendon groups']","['SNQ value', 'graft maturation', 'Lysholm score, Visual Analogues Scale, Tegner activity scale and modified Cincinnati knee rating system', '6-month SNQ values', 'Cincinnati score, Lysholm score and Tegner activity scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Level'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",50.0,0.0436319,"No clinical or functional differences have been found between the two treatment groups, supporting the suitability of using allograft in primary ACLR, when available.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cusumano', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Capitani', 'Affiliation': ""Department of Orthopedic Surgery and Traumatology, ASST GOM Niguarda, Piazza dell'Ospedale Maggiore, 3, 20162, Milan, Italy.""}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Messina', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'de Girolamo', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Viganò', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Ravasio', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Facchini', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy.'}, {'ForeName': 'Luca Maria', 'Initials': 'LM', 'LastName': 'Sconfienza', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zerbi', 'Affiliation': 'Casa Di Cura La Madonnina, Via Quadronno, 29, 20122, Milan, Italy.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Schoenhuber', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pozzoni', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Thiébat', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Via R. Galeazzi 4, 20161, Milan, Italy. gthiebat@gmail.com.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-021-06785-4']
262,34747917,Botulinum Toxin Injection Plus Topical Diltiazem for Chronic Anal Fissure: A Randomized Double-Blind Clinical Trial and Long-term Outcome.,"BACKGROUND


Chemical sphincterotomy avoids the risk of permanent incontinence in the treatment of chronic anal fissure, but it does not reach the efficacy of surgery and recurrence is high. Drug combination has been proposed to overcome these drawbacks.
OBJECTIVE


This study aimed to compare the clinical, morphological, and functional effects of combined therapy with botulinum toxin injection and topical diltiazem in chronic anal fissure and to assess the long-term outcome after healing.
DESIGN


This is a randomized, controlled, double-blind, 2-arm, parallel-group trial with a long-term follow-up.
SETTINGS


This study was conducted at a tertiary care center.
PATIENTS


A total of 70 consecutive patients were referred to the gastroenterology department of a hospital in Valencia, Spain.
INTERVENTION


After botulinum toxin injection (20 IU), patients were randomly assigned to local diltiazem (diltiazem group) or placebo gel (placebo group) for 12 weeks.
MAIN OUTCOME MEASURES


The primary outcome was fissure healing (evaluated by video register by 3 independent physicians). Secondary outcomes included symptomatic relief (30-day diary), effect on anal sphincters (manometry), safety, and long-term recurrence (24 months and 10 years).
RESULTS


Healing was achieved per protocol in 13 of 25 (52%) patients of the diltiazem group and 11 of 30 (36.7%) patients of the placebo group (p = 0.25); on an intention-to-treat basis in 37.1% and 31.4% (p = 0.61). Both groups displayed significant reduction of anal pressures. Thirty percent reported minor and transitory incontinence, without differences between groups. Nine (69.2%) of the diltiazem group and 6 (54.5%) of the placebo group experienced a relapse at 24 months (p = 0.67). The overall recurrence rate at 10 years was 83.3% (20/24 patients).
LIMITATIONS


This study was limited by the loss of patients during the trial. The low healing rate led to a small cohort to assess recurrence.
CONCLUSIONS


Combined botulinum toxin injection and topical diltiazem is not superior to botulinum toxin injection in the treatment of chronic anal fissure. Both options offer suboptimal healing rates. Long-term recurrence is high (>80% at 10 years) and might appear at any time after healing. See Video Abstract at http://links.lww.com/DCR/B527.
INYECCIN DE TOXINA BOTULNICA MS DILTIAZEM TPICO EN FISURA ANAL CRNICA UN ENSAYO CLNICO ALEATORIZADO DOBLE CIEGO Y RESULTADOS A LARGO PLAZO


ANTECEDENTES:La esfinterotomía química evita el riesgo de incontinencia permanente en el tratamiento de la fisura anal crónica, pero no alcanza la eficacia de la cirugía y la recurrencia es alta. Se ha propuesto la combinación de fármacos para superar estos inconvenientes.OBJETIVO:Comparar los efectos clínicos, morfológicos y funcionales de la terapia combinada con inyección de toxina botulínica y diltiazem tópico en fisura anal crónica y evaluar el resultado a largo plazo después de la cicatrización.DISEÑO:Ensayo aleatorizado, controlado, doble ciego, de dos brazos, de grupos paralelos con un seguimiento a largo plazo.ESCENARIO:Estudio realizado en un centro de atención terciaria.PACIENTES:Un total de 70 pacientes consecutivos referidos al servicio de gastroenterología de un hospital de Valencia, España.INTERVENCIÓN:Después de la inyección de toxina botulínica (20UI), los pacientes fueron asignados al azar a diltiazem local (grupo de diltiazem) o gel de placebo (grupo de placebo) durante 12 semanas.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la cicatrización de la fisura (evaluado por registro de video por tres médicos independientes). Los resultados secundarios incluyeron alivio sintomático (diario de 30 días), efecto sobre los esfínteres anales (manometría), seguridad y recurrencia a largo plazo (24 meses y 10 años).RESULTADOS:La curación se logró por protocolo en 13/25 (52%) en el grupo de Diltiazem y 11/30 (36,7%) en el grupo de Placebo (p = 0.25); por intención de tratar en el 37.1% y el 31.4%, respectivamente (p = 0.61). Ambos grupos mostraron una reducción significativa de las presiones anales. El 30% refirió incontinencia leve y transitoria, sin diferencias entre grupos. 9 (69.2%) del grupo de Diltiazem y 6 (54.5%) del grupo de placebo recurrieron a los 24 meses (p = 0.67). La tasa global de recurrencia a los 10 años fue del 83.3% (20/24 pacientes).LIMITACIONES:La pérdida de pacientes a lo largo del ensayo. La baja tasa de curación llevó a una pequeña cohorte para evaluar la recurrencia.CONCLUSIONES:La inyección combinada de toxina botulínica y diltiazem tópico no es superior a la inyección de TB en el tratamiento de la fisura anal crónica. Ambas opciones ofrecen tasas de curación subóptimas. La recurrencia a largo plazo es alta (> 80% a los 10 años) y puede aparecer en cualquier momento después de la curación. Consulte Video Resumen en http://links.lww.com/DCR/B527.",2021,La inyección combinada de toxina botulínica y diltiazem tópico no es superior a la inyección de TB en el tratamiento de la fisura anal crónica.,"['Chronic Anal Fissure', 'y funcionales', '70 consecutive patients were referred to the gastroenterology department of a hospital in Valencia, Spain', 'y 10 años).RESULTADOS', 'de toxina botulínica y diltiazem tópico en fisura anal crónica', 'chronic anal fissure']","['con inyección', 'DISEÑO', 'o gel de placebo (grupo de placebo', 'Placebo', 'botulinum toxin injection', 'alcanza', 'botulinum toxin injection and topical diltiazem', 'placebo', 'Botulinum Toxin Injection Plus Topical Diltiazem', 'Diltiazem', 'diltiazem local (grupo de diltiazem', 'local diltiazem (diltiazem group) or placebo gel (placebo', 'diltiazem']","['symptomatic relief (30-day diary), effect on anal sphincters (manometry), safety, and long-term recurrence', 'Healing', 'La tasa global de recurrencia', 'transitory incontinence', 'anal pressures', 'fissure healing', 'overall recurrence rate', 'low healing rate', 'chronic anal fissure']","[{'cui': 'C0349071', 'cui_str': 'Chronic anal fissure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0587464', 'cui_str': 'Gastroenterology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0002760', 'cui_str': 'Structure of sphincter ani muscle'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0349071', 'cui_str': 'Chronic anal fissure'}]",70.0,0.197335,La inyección combinada de toxina botulínica y diltiazem tópico no es superior a la inyección de TB en el tratamiento de la fisura anal crónica.,"[{'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Herreros', 'Affiliation': 'Department of Gastroenterology, Hospital de Villajoyosa, Alicante, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Espi', 'Affiliation': 'Department of General Surgery, Hospital Clínico Universitario, University of Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Montón Rodriguez', 'Affiliation': 'Department of Gastroenterology, Hospital Clínico Universitario, University of Valencia, Spain.'}, {'ForeName': 'Eduardo García-', 'Initials': 'EG', 'LastName': 'Granero', 'Affiliation': 'Digestive Surgery Unit, Department of General Surgery, Hospital Universitario y Politecnico La Fe, University of Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Sanchiz', 'Affiliation': 'Department of Pharmacy, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Francisco L', 'Initials': 'FL', 'LastName': 'Ferriols', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Castellón, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Almela', 'Affiliation': 'Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Hernandez', 'Affiliation': 'Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Mora', 'Affiliation': 'Department of Pharmacy, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Mínguez', 'Affiliation': 'Department of Pharmacy, Hospital Clínico Universitario de Valencia, Spain.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001983']
263,34785365,Clinical Effects of Repetitive Transcranial Magnetic Stimulation of the Motor Cortex Are Associated With Changes in Resting-State Functional Connectivity in Patients With Fibromyalgia Syndrome.,"In this double-blinded, sham-controlled, counterbalanced, and crossover study, we investigated the potential neuroplasticity underlying pain relief and daily function improvements following repetitive transcranial magnetic stimulation of the motor cortex (M1-rTMS) in fibromyalgia syndrome (FMS) patients. Specifically, we used magnetic resonance imaging (MRI) to examine changes in brain structural and resting-state functional connectivity (rsFC) that correlated with improvements in FMS symptomology following M1-rTMS. Twenty-seven women with FMS underwent real and sham treatment series, each consisting of 10 daily treatments of 10Hz M1-rTMS over 2 weeks, with a washout period in between. Before and after each series, participants underwent anatomical and resting-state functional MRI scans and questionnaire assessments of FMS-related clinical pain and functional and psychological burdens. The expected reductions in FMS-related symptomology following M1-rTMS occurred with the real treatment only and correlated with rsFC changes in brain areas associated with pain processing and modulation. Specifically, between the ventromedial prefrontal cortex and the M1 (t = -5.54, corrected P = .002), the amygdala and the posterior insula (t = 5.81, corrected P = .044), and the anterior and posterior insula (t = 6.01, corrected P = .029). Neither treatment significantly changed brain structure. Therefore, we provide the first evidence of an association between the acute clinical effects of M1-rTMS in FMS and functional alterations of brain areas that have a significant role in the experience of chronic pain. Structural changes could potentially occur over a more extended treatment period. PERSPECTIVE: We show that the neurophysiological mechanism of the improvement in fibromyalgia symptoms following active, but not sham, rTMS applied to M1 involves changes in resting-state functional connectivity in sensory, affective and cognitive pain processing brain areas, thus substantiating the essence of fibromyalgia syndrome as a treatable brain-based disorder.",2022,The expected reductions in FMS-related symptomology following M1-rTMS occurred with the real treatment only and correlated with rsFC changes in brain areas associated with pain processing and modulation.,"['fibromyalgia syndrome (FMS) patients', 'Twenty-seven women with FMS', 'Patients with Fibromyalgia Syndrome']","['repetitive transcranial magnetic stimulation of the motor cortex (M1-rTMS', 'rTMS', 'M1-rTMS', '10Hz M1-rTMS', 'magnetic resonance imaging (MRI', 'Repetitive Transcranial Magnetic Stimulation']","['brain structure', 'brain structural and resting-state functional connectivity (rsFC', 'FMS symptomology', 'fibromyalgia symptoms']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",27.0,0.0789548,The expected reductions in FMS-related symptomology following M1-rTMS occurred with the real treatment only and correlated with rsFC changes in brain areas associated with pain processing and modulation.,"[{'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Argaman', 'Affiliation': 'Clinical Neurophysiology Lab, Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Granovsky', 'Affiliation': 'Clinical Neurophysiology Lab, Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel; Department of Neurology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Sprecher', 'Affiliation': 'Department of Neurology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Sinai', 'Affiliation': 'Department of Neurosurgery, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yarnitsky', 'Affiliation': 'Clinical Neurophysiology Lab, Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel; Department of Neurology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Weissman-Fogel', 'Affiliation': 'Department of Physical Therapy, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel. Electronic address: ifogel@univ.haifa.ac.il.'}]",The journal of pain,['10.1016/j.jpain.2021.11.001']
264,34773094,"Impact of high energy oral nutritional supplements consumed in the late afternoon on appetite, energy intake and cardio-metabolic risk factors in females with lower BMI.","BACKGROUND/OBJECTIVE


Morning consumption of a single dose of high-energy oral nutritional supplement (ONS) in females with a lower BMI displaces some of the food eaten at breakfast but increases overall daily energy intake. This study investigated the effectiveness of ONS intake in the late afternoon and for longer duration.
SUBJECTS/METHODS


Twenty-one healthy females (mean ± SD, age 25 ± 5 years; BMI 18.7 ± 1.2 kg/m 2 ) participated in a randomised, crossover study with two experimental trials. In the afternoon of days 1-5, participants consumed either ONS (2.510 MJ) or low-energy PLACEBO drink (0.377 MJ) and recorded food eaten at home. On day six, energy intake was measured during buffet meals, and energy expenditure, appetite measurements and blood samples were collected throughout the day.
RESULT


Over the 5-day period, in the ONS trial energy intake from evening meals was lower (ONS, 2.7 ± 0.25 MJ; Placebo, 3.6 ± 0.25 MJ, P = 0.01) but averaged total daily energy intake was higher (ONS, 9.2 ± 0.3 MJ; PLACEBO, 8.2 ± 0.4 MJ, P = 0.03). On day six, energy intake, appetite scores, plasma GLP-1 and PYY, and energy expenditure were not significantly different between the two trials but fasting insulin concentration and HOMA IR , were higher (P < 0.05) and insulin sensitivity score based on fasting insulin and TAG lower (P < 0.05) in ONS trial.
CONCLUSION


Late afternoon consumption of ONS for five consecutive days by females with a lower BMI has only a partial and short-lived energy intake suppression and thus increases daily energy intake but reduces insulin sensitivity.",2022,"On day six, energy intake, appetite scores, plasma GLP-1 and PYY, and energy expenditure were not significantly different between the two trials but fasting insulin concentration and HOMA IR , were higher (P < 0.05) and insulin sensitivity score based on fasting insulin and TAG lower (P < 0.05) in ONS trial.
","['females with lower BMI', 'Twenty-one healthy females (mean\u2009±\u2009SD, age 25\u2009±\u20095 years', 'females with a lower BMI displaces']","['ONS (2.510\u2009MJ) or low-energy PLACEBO drink', 'high-energy oral nutritional supplement (ONS']","['energy expenditure, appetite measurements and blood samples', 'appetite, energy intake and cardio-metabolic risk factors', 'fasting insulin concentration and HOMA IR', 'insulin sensitivity score based on fasting insulin and TAG lower', 'energy intake, appetite scores, plasma GLP-1 and PYY, and energy expenditure', 'total daily energy intake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",21.0,0.146911,"On day six, energy intake, appetite scores, plasma GLP-1 and PYY, and energy expenditure were not significantly different between the two trials but fasting insulin concentration and HOMA IR , were higher (P < 0.05) and insulin sensitivity score based on fasting insulin and TAG lower (P < 0.05) in ONS trial.
","[{'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Fatima', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Gerasimidis', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Malkova', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK. dalia.malkova@glasgow.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-021-01042-w']
265,34783998,Video-assisted self-reflection of resuscitations for resident education and improvement of leadership skills: A pilot study.,"INTRODUCTION


One of the most challenging aspects of Emergency Medicine (EM) residency is mastering the leadership skills required during a resuscitation. Use of resuscitation video recording for debriefing is gaining popularity in graduate medical education. However, there are limited studies of how video technology can be used to improve leadership skills in the emergency department. We aim to evaluate the utility of video-assisted self-reflection, compared with self-reflection alone, in the setting of resuscitation leadership.
METHODS


This was a prospective, randomized, controlled pilot study conducted in 2018 at an urban level 1 trauma center with a three-year EM residency program. The trial included postgraduate year (PGY) 2 and 3 residents (n = 10). Each resident acted as an individual team leader for a live real-time resuscitation in the emergency department. The authors classified a patient as a resuscitation if there was an immediate life- or limb-threatening disease process or an abnormal vital sign with an indication of hypoperfusion. Each resident was recorded as the team leader twice. Both control and intervention groups produced written self-reflection after their first recording. The intervention group viewed their resuscitation recording while completing the written reflection. After their reflection, all participants were recorded for a second resuscitation. Two faculty experts, blinded to the study, scored each video using the Concise Assessment of Leader Management (CALM) scale to measure the leadership skills of the resident team leader.
RESULTS


Five PGY‑3 and five PGY‑2 residents participated. The weighted kappa between the two experts was 0.45 (CI 0.34-0.56, p < 0.0001). The median gain score in the control group was -1.5 (IQR) versus 0.5 in the intervention group (IQR).
DISCUSSION


Video-assisted self-reflection showed positive gain score trends in leadership evaluation for residents during a resuscitation compared with the non-video assisted control group. This tool would be beneficial to implement in EM residency.",2022,"The median gain score in the control group was -1.5 (IQR) versus 0.5 in the intervention group (IQR).
",['2018\u202fat an urban level 1\xa0trauma center with a\xa0three-year EM residency program'],"['Video-assisted self-reflection of resuscitations', 'resuscitation video recording for debriefing', 'Emergency Medicine (EM) residency', 'video-assisted self-reflection, compared with self-reflection alone']","['median gain score', 'leadership skills']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0042650', 'cui_str': 'Audiovisual Recording'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0035182', 'cui_str': 'Residency'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}]",,0.0103736,"The median gain score in the control group was -1.5 (IQR) versus 0.5 in the intervention group (IQR).
","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Kava', 'Affiliation': 'Lincoln Hospital, New York City, USA. kaval@nychhc.org.'}, {'ForeName': 'Kerin', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Detroit Receiving Hospital, Detroit, MI, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ehrman', 'Affiliation': 'Sinai-Grace Hospital, Detroit, MI, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Smylie', 'Affiliation': 'Detroit Receiving Hospital, Detroit, MI, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McRae', 'Affiliation': 'Covenant Hospital, Saginaw, MI, USA.'}, {'ForeName': 'Elizebeth', 'Initials': 'E', 'LastName': 'Dubey', 'Affiliation': 'Detroit Receiving Hospital, Detroit, MI, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Reed', 'Affiliation': 'Detroit Receiving Hospital, Detroit, MI, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Messman', 'Affiliation': 'Sinai-Grace Hospital, Detroit, MI, USA.'}]",Perspectives on medical education,['10.1007/s40037-021-00690-9']
266,34787005,Effect of ofatumumab versus placebo in relapsing multiple sclerosis patients from Japan and Russia: Phase 2 APOLITOS study.,"BACKGROUND


Ofatumumab, the first fully human anti-CD20 monoclonal antibody, has been developed as a treatment for relapsing multiple sclerosis (RMS) which can be self-administered at home.
OBJECTIVE


To investigate the efficacy and safety of ofatumumab in RMS patients from Japan and Russia.
METHODS


APOLITOS included a 24-week, double-blind, placebo-controlled core-part followed by an open-label extension-part. Patients were randomized (2:1) to subcutaneous ofatumumab 20 mg or placebo. Primary outcome was the number of gadolinium-enhancing (Gd+) T1 lesions per scan over 24 weeks.
RESULTS


Sixty-four patients were randomized (ofatumumab,  n  = 43; placebo,  n  = 21). Primary endpoint was met; ofatumumab reduced Gd + T1 lesions versus placebo by 93.6% ( p  < 0.001) and the results were consistent across regions (Japan/Russia). Ofatumumab reduced annualized T2 lesion and relapse rate versus placebo by week 24. Both groups showed benefit from ofatumumab in the extension-part. Incidence of adverse events was lower with ofatumumab versus placebo (69.8% vs 81.0%); injection-related reactions were most common. No deaths, opportunistic infections, or malignancies were reported.
CONCLUSION


Ofatumumab demonstrated superior efficacy versus placebo, with sustained effect through 48 weeks in RMS patients from Japan/Russia. Switching to ofatumumab after 24 weeks led to rapid radiological and clinical benefits. Safety findings were consistent with pivotal trials.",2022,Incidence of adverse events was lower with ofatumumab versus placebo (69.8% vs 81.0%); injection-related reactions were most common.,"['Sixty-four patients were randomized (ofatumumab,  n  = 43', 'relapsing multiple sclerosis patients from Japan and Russia', 'RMS patients from Japan and Russia']","['subcutaneous ofatumumab 20 mg or placebo', 'placebo-controlled core-part followed by an open-label extension-part', 'placebo', 'ofatumumab versus placebo']","['number of gadolinium-enhancing (Gd+) T1 lesions per scan over 24 weeks', 'annualized T2 lesion and relapse rate', 'Incidence of adverse events', 'met; ofatumumab reduced Gd + T1 lesions', 'efficacy and safety', 'No deaths, opportunistic infections, or malignancies']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",64.0,0.430449,Incidence of adverse events was lower with ofatumumab versus placebo (69.8% vs 81.0%); injection-related reactions were most common.,"[{'ForeName': 'Jun-Ichi', 'Initials': 'JI', 'LastName': 'Kira', 'Affiliation': 'Translational Neuroscience Center, Graduate School of Medicine, Fukuoka Central Hospital, International University of Health and Welfare, Fukuoka, Japan/Department of Neurology, Brain and Nerve Center, Fukuoka Central Hospital, International University of Health and Welfare, Fukuoka, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Nakahara', 'Affiliation': 'Department of Neurology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Denis V', 'Initials': 'DV', 'LastName': 'Sazonov', 'Affiliation': 'Siberian District Medical Centre, Federal Medical and Biological Agency of Russia, Novosibirsk, Russia.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Kurosawa', 'Affiliation': 'Novartis Pharma KK, Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Tsumiyama', 'Affiliation': 'Novartis Pharma KK, Tokyo, Japan.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Willi', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zalesak', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Ratnakar', 'Initials': 'R', 'LastName': 'Pingili', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Dieter A', 'Initials': 'DA', 'LastName': 'Häring', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramanathan', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Bernd C', 'Initials': 'BC', 'LastName': 'Kieseier', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland/Department of Neurology, Medical Faculty, Heinrich-Heine-University, Duesseldorf, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Merschhemke', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Saida', 'Affiliation': 'Kansai Multiple Sclerosis Center and Kyoto Min-iren Central Hospital, Kyoto, Japan.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211055934']
267,34774406,Urinary Cell-Cycle Arrest Biomarkers as Early Predictors of Acute Kidney Injury After Ventricular Assist Device Implantation or Cardiac Transplantation.,"OBJECTIVES


Acute kidney injury (AKI) remains a leading source of morbidity and mortality after cardiothoracic surgery. Insulin-like growth factor-binding protein 7 (IGFBP7), and tissue inhibitor of metalloproteinases-2 (TIMP-2), are novel early-phase renal biomarkers that have been validated as sensitive predictors of AKI. Here the authors studied the efficacy of these biomarkers for predicting AKI after left ventricular assist device (LVAD) implantation and cardiac transplantation.
DESIGN/SETTING/PARTICIPANTS/INTERVENTIONS


This was a prospective study of 73 patients undergoing LVAD implantation (n = 37) or heart transplant (n = 36) from 2016 to 2017 at the authors' center. TIMP-2 and IGFBP7 were measured with the NephroCheck Test on urine samples before surgery and one-to-six hours after surgery. NephroCheck scores were assessed as predictors of moderate/severe AKI (Kidney Disease International Global Outcomes 2/3 creatinine criteria) within 48 hours of surgery, and the association with survival to one year was investigated.
MEASUREMENTS AND MAIN RESULTS


The LVAD and transplant cohorts overall were similar in demographics and baseline creatinine (p > 0.05), with the exception of having more African-American patients in the LVAD arm (p = 0.003). Eleven (30%) LVAD and 16 (44%) transplant patients developed moderate/severe AKI. Overall, AKI was associated with postsurgery NephroCheck (odds ratio [95% confidence interval] for 0.1 mg/dL increase: 1.36 [1.04-1.79]; p = 0.03), but not with baseline NephroCheck (p = 0.92). When analyzed by cohort, this effect remained for LVAD (1.68 [1.05-2.71]; p = 0.03) but not for transplant (p = 0.15). Receiver operating characteristic analysis showed postoperative NephroCheck to be superior to baseline creatinine in LVAD (p = 0.046). Furthermore, an increase of 0.1 mg/dL in postoperative NephroCheck was associated with a 10% increase in the risk of mortality (adjusted hazard ratio: 1.11 [1.01-1.21]; p = 0.04) independent of age and body mass index.
CONCLUSION


Assessment of TIMP-2 and IGFBP7 within six hours after surgery appeared effective at predicting AKI in patients with LVADs. Larger studies are warranted to validate these findings.",2022,Receiver operating characteristic analysis showed postoperative NephroCheck to be superior to baseline creatinine in LVAD (p = 0.046).,"[""73 patients undergoing LVAD implantation (n = 37) or heart transplant (n = 36) from 2016 to 2017 at the authors' center"", 'Acute kidney injury (AKI', 'Acute Kidney Injury', 'patients with LVADs']",['Ventricular Assist Device Implantation or Cardiac Transplantation'],"['risk of mortality', 'NephroCheck scores', 'moderate/severe AKI', 'TIMP-2 and IGFBP7']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]","[{'cui': 'C0397128', 'cui_str': 'Implantation of ventricular assist device'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0532025', 'cui_str': 'insulin-like growth factor binding protein-related protein 1'}]",73.0,0.216553,Receiver operating characteristic analysis showed postoperative NephroCheck to be superior to baseline creatinine in LVAD (p = 0.046).,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'Baylor University Medical Center, Dallas, TX; Baylor Scott & White Research Institute, Dallas, TX; Texas A&M Medical College, College Station, TX. Electronic address: Amit.Alam@BSWHealth.org.'}, {'ForeName': 'Aayla K', 'Initials': 'AK', 'LastName': 'Jamil', 'Affiliation': 'Baylor Scott & White Research Institute, Dallas, TX.'}, {'ForeName': 'Johanna S', 'Initials': 'JS', 'LastName': 'Van Zyl', 'Affiliation': 'Baylor Scott & White Research Institute, Dallas, TX.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Medel-Martinez', 'Affiliation': 'Baylor Scott & White Research Institute, Dallas, TX.'}, {'ForeName': 'Teodoro', 'Initials': 'T', 'LastName': 'Bottiglieri', 'Affiliation': 'Baylor University Medical Center, Dallas, TX; Baylor Scott & White Research Institute, Dallas, TX.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Wasek', 'Affiliation': 'Baylor University Medical Center, Dallas, TX.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Felius', 'Affiliation': 'Baylor Scott & White Research Institute, Dallas, TX.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lima', 'Affiliation': 'Medical City Heart Hospital, Dallas, TX.'}, {'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Hall', 'Affiliation': 'Baylor University Medical Center, Dallas, TX; Baylor Scott & White Research Institute, Dallas, TX; Texas A&M Medical College, College Station, TX.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Joseph', 'Affiliation': 'Medical City Heart Hospital, Dallas, TX; University of Maryland Medical Center, Baltimore, Maryland.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.10.013']
268,34785236,"Aspirin as a Treatment for ARDS: A Randomized, Placebo-Controlled Clinical Trial.","BACKGROUND


There is no pharmacologic treatment for ARDS. Platelets play an important role in the pathophysiology of ARDS. Preclinical, observational, and clinically relevant models of ARDS indicate aspirin as a potential therapeutic option.
RESEARCH QUESTION


Is enteral aspirin (75 mg, once daily) safe and effective in improving surrogate outcomes in adult patients with ARDS?
STUDY DESIGN AND METHODS


This randomized, double-blind (patient and investigator), allocation-concealed, placebo-controlled phase 2 trial was conducted in five UK ICUs. Patients fulfilling the Berlin definition of ARDS were randomly assigned at a 1:1 ratio to receive enteral aspirin (75 mg) or placebo, for a maximum of 14 days, using a computer-generated randomization schedule, with variable block size, stratified by vasopressor requirement. The primary end point was oxygenation index (OI) on day 7. Secondary outcomes included safety parameters and other respiratory physiological markers. Analyses were by intention to treat.
RESULTS


The trial was stopped early, due to slow recruitment, after 49 of a planned 60 patients were recruited. Twenty-four patients were allocated to aspirin and 25 to placebo. There was no significant difference in day 7 OI [aspirin group: unadjusted mean, 54.4 (SD 26.8); placebo group: 42.4 (SD 25); mean difference, 12.0; 95% CI, -6.1 to 30.1; P = .19]. Aspirin did not significantly impact the secondary outcomes. There was no difference in the number of adverse events between the groups (13 in each; OR, 1.04; 95% CI, 0.56-1.94; P = .56).
INTERPRETATION


Aspirin was well tolerated but did not improve OI or other physiological outcomes; a larger trial is not feasible in its current design.
TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT02326350; URL: www.
CLINICALTRIALS


gov.",2022,"There was no difference in the number of adverse events between the groups (13 in each, odds ratio 1.04, 95% CI 0.56 to 1.94, p=0.56).
","['acute respiratory distress syndrome (ARDS', 'Acute Respiratory Distress Syndrome', '24 patients', 'Patients fulfilling the Berlin definition of ARDS', 'adult patients with ARDS', 'controlled phase 2 trial was conducted in five UK intensive care units']","['Aspirin', 'aspirin', 'enteral aspirin 75mg or placebo', 'placebo', 'enteral aspirin']","['number of adverse events', 'safety parameters and other respiratory physiological markers', 'oxygenation index (OI']","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0983879', 'cui_str': 'Aspirin 75 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}]",24.0,0.870364,"There was no difference in the number of adverse events between the groups (13 in each, odds ratio 1.04, 95% CI 0.56 to 1.94, p=0.56).
","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Toner', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland. Electronic address: philip.toner@belfasttrsut.hscni.net.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Boyle', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.""}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'McNamee', 'Affiliation': 'Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Callaghan', 'Affiliation': 'Altnagelvin Area Hospital, Londonderry, Northern Ireland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nutt', 'Affiliation': 'Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Johnston', 'Affiliation': 'Antrim Area Hospital, Antrim, Northern Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Trinder', 'Affiliation': 'Ulster Hospital, Dundonald, Belfast, Northern Ireland.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McFarland', 'Affiliation': 'Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.'}, {'ForeName': 'Rejina', 'Initials': 'R', 'LastName': 'Verghis', 'Affiliation': 'Northern Ireland Clinical Trial Unit, Royal Hospitals, Belfast, Northern Ireland.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland; Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland.""}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': ""O'Kane"", 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland.""}]",Chest,['10.1016/j.chest.2021.11.006']
269,34781008,"A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence.","BACKGROUND


The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah).
METHODS


We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications.
RESULTS


From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033).
CONCLUSIONS


The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future.",2022,"VCSS, AVVQ scores, and most SF-36 domains improved in both groups (p<0.002).","['great saphenous vein incompetence', 'Between 2012 and 2018', 'Patients with symptomatic primary truncal GSV incompetence', '364 patients (175 limbs) were included; of which 189 limbs']","['MOCA + 2% POL liquid (2%-group) or MOCA + 3% POL liquid (3%-group', 'mechanochemical ablation using Clarivein® and liquid Polidocanol']","['quality of life', 'Postprocedural pain', 'aTS rate', 'VCSS, AVVQ scores, and most SF-36 domains', 'technical success (TS) defined as an open part of the treated vein segment <10cm in length', 'Superficial venous thrombosis', 'alternative technical success (aTS) defined as at least 85% occlusion of the treated vein segment, postoperative pain, VCSS, AVVQ and SF-36 scores, and complications', 'TS rate', 'overall TS rate']","[{'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0441474', 'cui_str': 'Chemical destruction'}, {'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0235511', 'cui_str': 'Superficial vein thrombosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",189.0,0.0783212,"VCSS, AVVQ scores, and most SF-36 domains improved in both groups (p<0.002).","[{'ForeName': 'Yee Lai', 'Initials': 'YL', 'LastName': 'Lam', 'Affiliation': 'Department of Dermatology, Erasmus University Medical Center, Rotterdam CE. Electronic address: yeelai_1@hotmail.com.'}, {'ForeName': 'Tamana', 'Initials': 'T', 'LastName': 'Alozai', 'Affiliation': 'Department of Surgery, Northwest Clinics, Alkmaar CE.'}, {'ForeName': 'Michiel A', 'Initials': 'MA', 'LastName': 'Schreve', 'Affiliation': 'Department of Surgery, Northwest Clinics, Alkmaar CE; Department of Surgery, Rode Kruis Ziekenhuis, Beverwijk.'}, {'ForeName': 'André A E A', 'Initials': 'AAEA', 'LastName': 'de Smet', 'Affiliation': 'Department of Vascular Surgery, Maasstad Hospital, Rotterdam CE.'}, {'ForeName': 'Anco C', 'Initials': 'AC', 'LastName': 'Vahl', 'Affiliation': 'Department of Vascular Surgery, OLVG, East Location, Amsterdam.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Nagtzaam', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, CE.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Lawson', 'Affiliation': 'Retired.'}, {'ForeName': 'Fred H M', 'Initials': 'FHM', 'LastName': 'Nieman', 'Affiliation': 'Retired.'}, {'ForeName': 'Cees H A', 'Initials': 'CHA', 'LastName': 'Wittens', 'Affiliation': 'Retired.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2021.10.016']
270,34780993,Real Bodies Not Required? Placebo Analgesia and Pain Perception in Immersive Virtual and Augmented Reality.,"Pain represents an embodied experience, wherein inferences are not only drawn from external sensory inputs, but also from bodily states. Previous research has demonstrated that a placebo administered to an embodied rubber hand can effectively induce analgesia, providing first evidence that placebos can work even when applied to temporarily embodied, artificial body parts. Using a heat pain paradigm, the present study investigates placebo analgesia and pain perception during virtual embodiment. We examined whether a virtual placebo (a sham heat protective glove) can successfully induce analgesia, even when administered to a virtual body. The analgesic efficacy of the virtual placebo to the real hand (augmented reality setting) or virtual hand (virtual reality setting) was compared to a physical placebo administered to the own, physical body (physical reality setting). Furthermore, pain perception and subjective embodiment were compared between settings. In this mixed design experiment, healthy participants (n = 48) were assigned to either an analgesia-expectation or control-expectation group, where subjective and objective pain was measured at pre- and post-intervention time points. Results demonstrate that pre-intervention pain intensity was lower in the virtual reality setting, and that participants in the analgesia-expectation group, after the intervention, exhibited significantly higher pain thresholds, and lower pain intensity and unpleasantness ratings than control-expectation participants, independent of the setting. Our findings show that a virtual placebo can elicit placebo analgesia comparable to that of a physical placebo, and that administration of a placebo does not necessitate physical bodily interaction to produce analgesic responses. PERSPECTIVE: This study demonstrates that a virtual placebo treatment, even when administered to a virtual body, can produce placebo analgesia. These findings indicate that the efficacy of a virtual placebo is comparable to that of a physical placebo, which could pave the way for effective new non-pharmacological approaches for pain management.",2022,"Results demonstrated that pre-intervention pain intensity was lower in the virtual reality setting, and that participants in the analgesia-expectation condition, after the intervention, exhibited significantly higher pain thresholds, and lower pain intensity and unpleasantness ratings than control-expectation participants, independent of the setting.",['healthy participants (n=48'],"['Placebo Analgesia and Pain Perception in Immersive Virtual and Augmented Reality', 'analgesia-expectation or control-expectation', 'virtual placebo', 'placebo', 'physical placebo']","['subjective and objective pain', 'pain thresholds, and lower pain intensity and unpleasantness ratings', 'pre-intervention pain intensity', 'Furthermore, pain perception and subjective embodiment', 'analgesic efficacy']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",48.0,0.0930207,"Results demonstrated that pre-intervention pain intensity was lower in the virtual reality setting, and that participants in the analgesia-expectation condition, after the intervention, exhibited significantly higher pain thresholds, and lower pain intensity and unpleasantness ratings than control-expectation participants, independent of the setting.","[{'ForeName': 'Jasmine Tian', 'Initials': 'JT', 'LastName': 'Ho', 'Affiliation': 'University of Zurich, Department of Psychology, Zurich, Switzerland; Brainability LLC, CH-8057 Zurich, Switzerland. Electronic address: jasmine.ho@uzh.ch.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krummenacher', 'Affiliation': 'University of Zurich, Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy, Psychotherapy and Psychosomatics, Zurich, Switzerland; Brainability LLC, CH-8057 Zurich, Switzerland.'}, {'ForeName': 'Marte Roel', 'Initials': 'MR', 'LastName': 'Lesur', 'Affiliation': 'University of Zurich, Department of Psychology, Zurich, Switzerland.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Saetta', 'Affiliation': 'University of Zurich, Department of Psychology, Zurich, Switzerland.'}, {'ForeName': 'Bigna', 'Initials': 'B', 'LastName': 'Lenggenhager', 'Affiliation': 'University of Zurich, Department of Psychology, Zurich, Switzerland.'}]",The journal of pain,['10.1016/j.jpain.2021.10.009']
271,34785366,"Impact of Bifrontal Home-Based Transcranial Direct Current Stimulation in Pain Catastrophizing and Disability due to Pain in Fibromyalgia: A Randomized, Double-Blind Sham-Controlled Study.","This randomized, double-blind trial tested the hypothesis that 20 sessions of home-based anodal(a)-transcranial direct current stimulation (tDCS) (2mA for 20 minutes) bifrontal, with anodal on the left dorsolateral prefrontal cortex (l-DLPFC) would be better than sham-(s)-tDCS to reduce scores on Pain Catastrophizing Scale and disability-related to pain assessed by the Profile of Chronic Pain: Screen (primary outcomes). Secondary outcomes were depressive symptoms, sleep quality, heat pain threshold , heat pain tolerance , and serum brain-derived-neurotrophic-factor (BDNF). Forty-eight women with fibromyalgia, 30 to 65 years-old were randomized into 2:1 groups [a-tDCS (n = 32) or s-tDCS (n = 16)]. Post hoc analysis revealed that a-tDCS reduced the Pain Catastrophizing Scale total scores by 51.38% compared to 26.96% in s-tDCS, and a-tDCS reduced Profile of Chronic Pain: Screen total scores by 31.43% compared to 19.15% in s-tDCS. The a-tDCS improved depressive symptoms, sleep quality and increased the heat pain tolerance. The delta-value in the serum BDNF (mean post treatment end minus pretreatment) was conversely correlated with the a-tDCS effect in pain catastrophizing. In contrast, the a-tDCS impact on reducing the disability-related to pain at the treatment end was positively associated with a reduction in the serum BDNF and improvement of depressive symptoms, sleep quality and pain catastrophizing symptoms. PERSPECTIVE: Home-based bifrontal tDCS with a-tDCS on the l-DLPFC are associated with a moderate effect size (ES) in the following outcomes: 1) Decreased rumination and magnification of pain catastrophizing. 2) Improved the disability for daily activities due to fibromyalgia symptoms. Overall, these findings support the feasibility of self-applied home-based tDCS on DLPFC to improve fibromyalgia symptoms.",2022,"Post hoc analysis revealed that a-tDCS reduced the PCS total scores by 51.38% compared to 26.96% in s-tDCS, and a-tDCS reduced PCP:S total scores by 31.43% compared to 19.15% in s-tDCS.","['pain catastrophizing and disability due to pain in fibromyalgia', 'Forty-eight women with fibromyalgia, 30-65 years-old']","['tDCS', 'bifrontal home-based transcranial direct current stimulation', 'home-based anodal(a)-transcranial direct current stimulation (tDCS) (2mA for 20 min) bifrontal, with anodal on the left dorsolateral prefrontal cortex (l-DLPFC']","['rumination and magnification of pain catastrophizing', 'DRP', 'depressive symptoms, sleep quality and increased the HPTo', 'PCP:S total scores', 'depressive symptoms, sleep quality, heat pain threshold (HPT), heat pain tolerance (HPTo), and serum brain-derived-neurotrophic-factor (BDNF', 'PCS total scores', 'Pain Catastrophizing Scale (PCS) and disability-related to pain (DRP', 'serum BDNF and improvement of depressive symptoms, sleep quality and pain catastrophizing symptoms', 'disability for daily activities due to fibromyalgia symptoms', 'fibromyalgia symptoms', 'delta-value in the serum BDNF']","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",48.0,0.229433,"Post hoc analysis revealed that a-tDCS reduced the PCS total scores by 51.38% compared to 26.96% in s-tDCS, and a-tDCS reduced PCP:S total scores by 31.43% compared to 19.15% in s-tDCS.","[{'ForeName': 'Wolnei', 'Initials': 'W', 'LastName': 'Caumo', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil; Pain and Palliative Care Service at HCPA, Brazil; Department of Surgery, School of Medicine, UFRGS, Brazil. Electronic address: wcaumo@hcpa.edu.br.'}, {'ForeName': 'Rael Lopes', 'Initials': 'RL', 'LastName': 'Alves', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Vicuña', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Camila Fernanda da Silveira', 'Initials': 'CFDS', 'LastName': 'Alves', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Ramalho', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Paulo R S', 'Initials': 'PRS', 'LastName': 'Sanches', 'Affiliation': 'Laboratory of Biomedical Engineer at HCPA, Porto Alegre, Brazil.'}, {'ForeName': 'Danton P', 'Initials': 'DP', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Biomedical Engineer at HCPA, Porto Alegre, Brazil.'}, {'ForeName': 'Iraci Lucena', 'Initials': 'IL', 'LastName': 'da Silva Torres', 'Affiliation': 'Laboratorio de Farmacologia da Dor e Neuromodulação: Investigacoes Pre-clinicas, Centro de Pesquisa Experimental (CPE), Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Laboratory of Neuromodulation and Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Boston, Massachusetts.'}]",The journal of pain,['10.1016/j.jpain.2021.11.002']
272,34787944,"Reply to ""Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial"" by Martín-Marcos et al.",,2022,"First, topical lidocaine increased the proportion of procedures which endoscopists rated patient tolerance as good, but all procedures in the control group were successfully completed.",[],"['pharyngeal lidocaine anesthesia', 'pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy', 'lidocaine']",['proportion of procedures which endoscopists rated patient tolerance'],[],"[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",,0.0693563,"First, topical lidocaine increased the proportion of procedures which endoscopists rated patient tolerance as good, but all procedures in the control group were successfully completed.","[{'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fu-Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.14195']
273,34795034,"Tiotropium treatment for bronchiectasis: a randomised, placebo-controlled, crossover trial.","BACKGROUND


Tiotropium  via  the HandiHaler device is an established long-acting, anticholinergic bronchodilator that prevents exacerbations and improves lung function in patients with chronic obstructive pulmonary disease. We hypothesised that tiotropium would reduce pulmonary exacerbations and improve lung function in patients with stable bronchiectasis and airflow limitation, and assessed the effect of tiotropium on these outcomes.
METHODS


In a randomised, double-blind, two-period crossover trial, we recruited adult patients from three hospitals in New Zealand. Patients were excluded if they had a smoking history of >20 pack-years. Patients were assigned to either the tiotropium-placebo or placebo-tiotropium sequence in a 1:1 ratio, using randomly permuted blocks stratified by centre. Participants and investigators were masked to treatment allocation. Eligible patients received tiotropium 18 μg  via  HandiHaler daily for 6 months followed by 6 months of placebo, or  vice versa , with a washout period of 4 weeks. The primary end-point was rate of event-based exacerbations during the 6-month period. Primary analyses were carried out in an intention-to-treat set.
RESULTS


90 patients were randomly assigned and 85 completed both treatment cycles. The rate of exacerbations was 2.17 per year under the tiotropium treatment and 2.27 per year under placebo (rate ratio 0.96, 95% CI 0.72-1.27; p=0.77). Tiotropium, compared with placebo, improved forced expiratory volume in 1 s by 58 mL (95% CI 23-92 mL; p=0.002). Adverse events were similar under both treatments.
CONCLUSIONS


Tiotropium  via  HandiHaler over 6 months significantly improved lung function but not frequency of exacerbations. Further research is required to understand the clinical context and significance of these findings.",2022,"Tiotropium, as compared with placebo, improved FEV 1  by 58 mL (95% CI 23-92; p=0.002).","['patients with stable bronchiectasis and airflow limitation', 'Patients were excluded if they had a smoking history of more than 20 pack years', 'bronchiectasis', 'adult patients from 3 hospitals in New Zealand', 'Ninety patients', 'patients with COPD']","['tiotropium-placebo or placebo-tiotropium sequence', 'Tiotropium', 'tiotropium 18mcg  via  the HandiHaler® device daily for 6\u2005months followed by 6\u2005months of placebo', 'tiotropium', 'placebo']","['pulmonary exacerbations', 'Adverse events', 'FEV', 'lung function', 'rate of exacerbations', 'rate of event-based exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",90.0,0.805589,"Tiotropium, as compared with placebo, improved FEV 1  by 58 mL (95% CI 23-92; p=0.002).","[{'ForeName': 'Lata', 'Initials': 'L', 'LastName': 'Jayaram', 'Affiliation': 'Western Health, Footscray, Australia Lata.Jayaram@wh.org.au.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'Dept of Statistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Catherina L', 'Initials': 'CL', 'LastName': 'Chang', 'Affiliation': 'Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Tong', 'Affiliation': 'Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tuffery', 'Affiliation': 'Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Fergusson', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Jeon', 'Affiliation': 'Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Milne', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Karalus', 'Affiliation': 'Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hotu', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Conroy', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Counties Manukau District Health Board, Auckland, New Zealand.'}]",The European respiratory journal,['10.1183/13993003.02184-2021']
274,34785078,"Effect of progressive muscle relaxation on postoperative pain, fatigue, and vital signs in patients with head and neck cancers: A randomized controlled trial.","OBJECTIVE


Surgery for head and neck cancers are associated with significant preoperative stress. We investigated the effects of progressive muscle relaxation (PMR) on postoperative pain, fatigue, and vital signs in patients with head and neck cancers.
METHODS


All patients were hospitalized and randomly assigned to intervention or usual care groups. A generalized estimating equation was used to evaluate the PMR effects on pain and symptoms across the preoperative day to postoperative day 10.
RESULTS


The PMR group displayed significantly lower overall pain and muscle tightness than control group along with the timeline of multiple measurements (p < 0.01). PMR significantly reduces sleep disturbances and levels of fatigue, anxiety, and depression compared with the control group with time trend (p < 0.01). PMR also lowered the respiratory rates and diastolic blood pressure (p < 0.01).
CONCLUSIONS


PMR can reduce sleep disturbances and levels of pain, fatigue, muscle tightness, anxiety, and depression in patients with head and neck cancer undergoing major surgeries. Future study should focus on improving the effectiveness of the exercise and standardization of the application.
PRACTICAL IMPLICATIONS


progressive muscle relaxation help relieve discomforts in patients with head and neck cancers with minimal costs and efforts.",2022,"PMR significantly reduces sleep disturbances and levels of fatigue, anxiety, and depression compared with the control group with time trend (p < 0.01).","['patients with head and neck cancers with minimal costs and efforts', 'patients with head and neck cancers', 'head and neck cancers', 'patients with head and neck cancer undergoing major surgeries']","['progressive muscle relaxation (PMR', 'PMR', 'progressive muscle relaxation']","['postoperative pain, fatigue, and vital signs', 'respiratory rates and diastolic blood pressure', 'sleep disturbances and levels of fatigue, anxiety, and depression', 'overall pain and muscle tightness', 'sleep disturbances and levels of pain, fatigue, muscle tightness, anxiety, and depression', 'PMR effects on pain and symptoms', 'PMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0313569,"PMR significantly reduces sleep disturbances and levels of fatigue, anxiety, and depression compared with the control group with time trend (p < 0.01).","[{'ForeName': 'El-Wui', 'Initials': 'EW', 'LastName': 'Loh', 'Affiliation': 'Center for Evidence-Based Health Care, Shared Decision Making Resource Center, Department of Medical Research, Taipei Medical University Shuang Ho Hospital, Zhonghe District, New Taipei City, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Huei-Fen', 'Initials': 'HF', 'LastName': 'Shih', 'Affiliation': 'Department of Nursing, China Medical University Hospital, Taichung, Taiwan; Cell therapy Center, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Chung-Kwei', 'Initials': 'CK', 'LastName': 'Lin', 'Affiliation': 'School of Dental Technology, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Tsai-Wei', 'Initials': 'TW', 'LastName': 'Huang', 'Affiliation': 'Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan; Center for Nursing and Healthcare Research in Clinical Practice Application, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: tsaiwei@tmu.edu.tw.'}]",Patient education and counseling,['10.1016/j.pec.2021.10.034']
275,34797419,Efficacy of artificial oocyte activation in patients with embryo developmental problems: a sibling oocyte control study.,"PURPOSE


To explore whether artificial oocyte activation (AOA) can improve embryo developmental potentiality and pregnancy outcomes for patients with a history of embryo developmental problem.
METHODS


This was a retrospective study and candidate patients with embryo development problems were collected. A total of 1422 MII eggs from the enrolled 140 patients were randomized divided equally into 2 groups, half for the AOA group (AOA), and the rest of sibling mature eggs for the control group (non-AOA). The patients were further divided into two subgroups: (1) the rate of good-quality day 3 embryos was 0% (group 1, n = 66); (2) the rate of good-quality day 3 embryos ranged from 1 to 30% (group 2, n = 74).
RESULTS


In the early embryonic growth, there were no significant differences in the outcomes of AOA and non-AOA groups in terms of normal fertilization rates, cleavage rates, day 3 good-quality embryo rates and available blastocyst rates (72.7% vs. 79.3%, 97.4% vs. 98.0%, 20.1% vs. 19.7%, 6.6% vs. 8.4% in group 1, respectively; 77.7% vs. 81.9%, 98.1% vs. 97.0%, 25.8% vs. 22.1%, 9.6% vs. 9.3% in group 2, respectively). In the late embryonic growth, no significant differences were found in biochemical and clinical pregnancy rates, implantation rates, miscarriage rates, and live-birth rates (50.0% vs. 45.2%, 45.2% vs. 40.5%, 37.3% vs. 31.3%, 10.5% vs. 11.8%, 40.5% vs. 35.7%, respectively) between two groups. In addition, neonatal outcomes were similar in both the groups as well.
CONCLUSION


Our study demonstrated that the AOA using ionomycin 1 h after ICSI did not bring benefits to the early or late development of embryos derived from patients with a history of embryo developmental problems.",2022,"In the early embryonic growth, there were no significant differences in the outcomes of AOA and non-AOA groups in terms of normal fertilization rates, cleavage rates, day 3 good-quality embryo rates and available blastocyst rates (72.7% vs. 79.3%, 97.4% vs. 98.0%, 20.1% vs. 19.7%, 6.6% vs. 8.4% in group 1, respectively; 77.7% vs. 81.9%, 98.1% vs. 97.0%, 25.8% vs. 22.1%, 9.6% vs. 9.3% in group 2, respectively).","['patients with embryo developmental problems', 'candidate patients with embryo development problems', 'patients with a history of embryo developmental problem', 'A total of 1422 MII eggs from the enrolled 140 patients']","['artificial oocyte activation (AOA', 'artificial oocyte activation']","['biochemical and clinical pregnancy rates, implantation rates, miscarriage rates, and live-birth rates', 'normal fertilization rates, cleavage rates, day 3 good-quality embryo rates and available blastocyst rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0013936', 'cui_str': 'Embryo Development'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}]",140.0,0.109798,"In the early embryonic growth, there were no significant differences in the outcomes of AOA and non-AOA groups in terms of normal fertilization rates, cleavage rates, day 3 good-quality embryo rates and available blastocyst rates (72.7% vs. 79.3%, 97.4% vs. 98.0%, 20.1% vs. 19.7%, 6.6% vs. 8.4% in group 1, respectively; 77.7% vs. 81.9%, 98.1% vs. 97.0%, 25.8% vs. 22.1%, 9.6% vs. 9.3% in group 2, respectively).","[{'ForeName': 'Mingru', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Menghui', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Wenzhi', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Jilang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Qifeng', 'Initials': 'Q', 'LastName': 'Lyu', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China. lyuqifeng@126.com.""}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China. yanzheng369@163.com.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, People's Republic of China. libinliccc@163.com.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-021-06329-8']
276,34788694,Pooled microbiological findings and efficacy outcomes by pathogen in adults with community-acquired bacterial pneumonia from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 phase 3 trials of lefamulin versus moxifloxacin.,"OBJECTIVES


Lefamulin, a pleuromutilin antibiotic approved for community-acquired bacterial pneumonia (CABP), was evaluated for microbiological efficacy in a prespecified pooled analysis of LEAP 1 and 2 phase 3 clinical trial data in patients with CABP.
METHODS


In LEAP 1, adults (PORT risk class III‒V) received intravenous (IV) lefamulin 150 mg every 12 h (q12h) for 5‒7 days or moxifloxacin 400 mg every 24 h (q24h) for 7 days, with optional IV-to-oral switch. In LEAP 2, adults (PORT II‒IV) received oral lefamulin 600 mg q12h for 5 days or moxifloxacin 400 mg q24h for 7 days. Primary outcomes were early clinical response (ECR) at 96 ± 24 h after treatment start and investigator assessment of clinical response (IACR) 5‒10 days after the last dose. Secondary outcomes included ECR and IACR in patients with a baseline CABP pathogen (detected via culture, urinary antigen testing, serology and/or real-time PCR).
RESULTS


Baseline CABP pathogens were detected in 709/1289 patients (55.0%; microbiological intention-to-treat population). The most frequently identified pathogens were Streptococcus pneumoniae (61.9% of patients) and Haemophilus influenzae (29.9%); 25.1% had atypical pathogens and 33.1% had polymicrobial infections. Pathogens were identified most frequently by PCR from sputum, followed by culture from respiratory specimens. In patients with baseline CABP pathogens, ECR rates were 89.3% (lefamulin) and 93.0% (moxifloxacin); IACR success rates were 83.2% and 86.7%, respectively. Results were consistent across CABP pathogens, including drug-resistant isolates and polymicrobial infections.
CONCLUSION


Lefamulin is a valuable IV and oral monotherapy option for empirical and directed CABP treatment in adults.",2022,The most frequently identified pathogens in this population were Streptococcus pneumoniae (61.9% of patients) and Haemophilus influenzae (29.9%); 25.1% had atypical pathogens and 33.1% had polymicrobial infections.,"['patients with CABP', 'adults', 'Adults With Community-Acquired Bacterial Pneumonia from the Lefamulin Evaluation Against Pneumonia (LEAP']","['Moxifloxacin', 'moxifloxacin', 'intravenous (IV) lefamulin', 'Lefamulin', 'oral lefamulin 600\xa0mg q12h (5 days) or moxifloxacin']","['early clinical response (ECR) 96±24', 'IACR success rates', 'ECR and IACR in patients with a baseline CABP pathogen (detected via culture, urinary antigen test, serology, and/or real-time PCR', 'ECR rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456394', 'cui_str': 'Community acquired'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585327', 'cui_str': 'Every twelve hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456394', 'cui_str': 'Community acquired'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0729856', 'cui_str': 'Antigen test'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}]",,0.254794,The most frequently identified pathogens in this population were Streptococcus pneumoniae (61.9% of patients) and Haemophilus influenzae (29.9%); 25.1% had atypical pathogens and 33.1% had polymicrobial infections.,"[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Paukner', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria. Electronic address: Susanne.Paukner@nabriva.com.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goldberg', 'Affiliation': 'Nabriva Therapeutics US, Inc., Fort Washington, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Alexander', 'Affiliation': 'Nabriva Therapeutics US, Inc., Fort Washington, PA, USA.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'Das Consulting, Guerneville, CA, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Heinrich', 'Affiliation': 'Accelerō® Bioanalytics GmbH, Berlin, Germany.'}, {'ForeName': 'Pritty', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Covance Central Laboratory Services, Indianapolis, IN, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Moran', 'Affiliation': 'Department of Emergency Medicine & Division of Infectious Diseases, Olive View-UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sandrock', 'Affiliation': 'Department of Internal Medicine, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'File', 'Affiliation': 'Infectious Disease Division, Summa Health, Akron, OH, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Vidal', 'Affiliation': 'Department of Microbiology and Immunology, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Waites', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Gelone', 'Affiliation': 'Nabriva Therapeutics US, Inc., Fort Washington, PA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schranz', 'Affiliation': 'Nabriva Therapeutics US, Inc., Fort Washington, PA, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2021.10.021']
277,34792264,Effect of amino acid-based formula added to four-food elimination in adult eosinophilic esophagitis patients: A randomized clinical trial.,"BACKGROUND


Elimination of key foods restricts dietary options in eosinophilic esophagitis (EoE) patients. Addition of amino acid-based formula (AAF) to an elimination diet might facilitate adherence and, therefore, enhance efficacy of dietary management.
AIM


To evaluate whether addition of AAF to a four-food elimination diet (FFED) is more effective than FFED alone in decreasing eosinophilia, endoscopic signs, and clinical outcomes.
METHODS


This randomized controlled trial enrolled 41 adult patients with active EoE (≥15 eosinophils (eos) per high power field (hpf)) at baseline biopsy. Subjects were randomized (1:1 ratio) to groups given a FFED or FFED with addition of AAF providing 30% of their daily energy needs (FFED + AAF). Histological disease activity, endoscopic signs, symptoms, and disease-related quality of life (EoEQoL) were measured at baseline and after 6 weeks of intervention.
RESULTS


Patients (60% male, age 34.5 (interquartile range (IQR) 29-42.8 years)) were randomized to FFED (n = 20) or FFED + AAF (n = 21); 40 participants completed the diet. Complete histological remission (<15 eos/hpf) was achieved in 48% of FFED + AAF subjects (n = 21) vs. 25% of FFED subjects (n = 20), respectively (p = 0.204). Peak eosinophil counts (PEC) decreased significantly in both groups between baseline and week 6, but the change in PEC between groups was not different (p = 0.130). A significant but similar endoscopic and symptomatic reduction was observed in both groups (all; p<0.05). Total EoEQoL scores significantly improved in the FFED + AAF group between baseline and week 6 (p = 0.007), and not in the FFED group.
CONCLUSION


The addition of AAF to a FFED did not lead to a larger decrease in PEC between baseline and 6 weeks, but may result in a significant improvement of QoL in adult EoE patients NL6014 (NTR6778).",2022,"Complete histological remission (<15 eos/hpf) was achieved in 48% of FFED + AAF subjects (n = 21) vs. 25% of FFED subjects (n = 20), respectively (p = 0.204).","['n\xa0=\xa021); 40 participants completed the diet', 'adult eosinophilic esophagitis patients', 'Patients (60% male, age 34.5 (interquartile range (IQR) 29-42.8\xa0years', '41 adult patients with active EoE (≥15 eosinophils (eos) per high power field (hpf)) at baseline biopsy', 'eosinophilic esophagitis (EoE) patients']","['amino acid-based formula added to four-food elimination', 'AAF to a four-food elimination diet (FFED', 'FFED\xa0+\xa0AAF', 'FFED', 'FFED or FFED with addition of AAF providing 30% of their daily energy needs (FFED\xa0+\xa0AAF', 'amino acid-based formula (AAF']","['Total EoEQoL scores', 'endoscopic and symptomatic reduction', 'Complete histological remission', 'Peak eosinophil counts (PEC', 'PEC', 'Histological disease activity, endoscopic signs, symptoms, and disease-related quality of life (EoEQoL']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0439530', 'cui_str': '/HPF'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0452376', 'cui_str': 'Elimination diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205450', 'cui_str': '4'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",41.0,0.116934,"Complete histological remission (<15 eos/hpf) was achieved in 48% of FFED + AAF subjects (n = 21) vs. 25% of FFED subjects (n = 20), respectively (p = 0.204).","[{'ForeName': 'Willemijn E', 'Initials': 'WE', 'LastName': 'de Rooij', 'Affiliation': 'Department of Gastroenterology & Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Berber', 'Initials': 'B', 'LastName': 'Vlieg-Boerstra', 'Affiliation': 'Department of Paediatrics, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Marijn J', 'Initials': 'MJ', 'LastName': 'Warners', 'Affiliation': 'Department of Gastroenterology & Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Marleen T J', 'Initials': 'MTJ', 'LastName': 'Van Ampting', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Betty C A M', 'Initials': 'BCAM', 'LastName': 'van Esch', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Simone R B M', 'Initials': 'SRBM', 'LastName': 'Eussen', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Bredenoord', 'Affiliation': 'Department of Gastroenterology & Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14291']
278,34801917,"A pilot, feasibility, randomised controlled trial of midodrine as adjunctive vasopressor for low-dose vasopressor-dependent hypotension in intensive care patients: The MAVERIC study.","PURPOSE


To assess the feasibility and physiological efficacy of adjunctive midodrine in patients with vasopressor-dependent hypotension.
MATERIALS AND METHODS


This was a pilot, open label, randomised controlled trial. Patients were enrolled from two tertiary intensive care units on low dose intravenous vasopressor therapy for more than 24 h. We randomly assigned patients to receive either adjunctive midodrine (10 mg every 8 h) or usual care. The primary efficacy outcome was time to cessation of intravenous vasopressor therapy. Secondary outcomes included protocol compliance, ICU and hospital length of stay.
RESULTS


We screened 381 patients over 22-months and enrolled 62 (32 in midodrine group, 30 in usual care group). Median time to cessation of vasopressor infusion was 16.5 h for midodrine vs 19 h for usual care (p = 0.22). Time in ICU (50 [25.50, 74.00] hours for midodrine v 59 [38.50, 93.25] hours for usual care, p = 0.14) and hospital length of stay (9 days vs. 7.5 days, p = 0.92) were similar. Protocol compliance was 96.9%. One patient ceased midodrine early due to symptomatic bradycardia.
CONCLUSIONS


Adjunctive midodrine therapy was feasible with acceptable compliance, duration of therapy, and safety profile. However, at the chosen dose, there was no evidence of physiological or clinical efficacy.",2022,Median time to cessation of vasopressor infusion was 16.5 h for midodrine vs 19 h for usual care (p = 0.22).,"['381 patients over 22-months and enrolled 62 (32 in midodrine group, 30 in usual care group', 'Patients were enrolled from two tertiary intensive care units on low dose intravenous vasopressor therapy for more than 24\xa0h', 'patients with vasopressor-dependent hypotension', 'intensive care patients']","['adjunctive midodrine (10\xa0mg every 8\xa0h) or usual care', 'adjunctive midodrine', 'midodrine']","['Protocol compliance', 'acceptable compliance, duration of therapy, and safety profile', 'protocol compliance, ICU and hospital length of stay', 'hospital length of stay', 'time to cessation of intravenous vasopressor therapy', 'Time in ICU', 'physiological or clinical efficacy', 'Median time to cessation of vasopressor infusion']","[{'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026078', 'cui_str': 'Midodrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]","[{'cui': 'C0026078', 'cui_str': 'Midodrine'}]","[{'cui': 'C0525058', 'cui_str': 'Protocol Compliance'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",381.0,0.0704155,Median time to cessation of vasopressor infusion was 16.5 h for midodrine vs 19 h for usual care (p = 0.22).,"[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Costa-Pinto', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia; Department of Critical Care, Department of Medicine, the University of Melbourne, Parkville, Victoria, Australia. Electronic address: rahul.costa-pinto@austin.org.au.'}, {'ForeName': 'Zhen-Ti', 'Initials': 'ZT', 'LastName': 'Yong', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington, New Zealand.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Udy', 'Affiliation': 'Department of Intensive Care, The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington, New Zealand; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Medical Research Institute of New Zealand, Private Bag, 7902, Wellington, New Zealand; Department of Critical Care, Department of Medicine, the University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia; Department of Critical Care, Department of Medicine, the University of Melbourne, Parkville, Victoria, Australia; Data Analytics Research and Evaluation Centre, The University of Melbourne and Austin Hospital, Melbourne, Australia.'}]",Journal of critical care,['10.1016/j.jcrc.2021.11.004']
279,34802339,"High acceptability of HIV self-testing in a randomized trial among transgender women and men who have sex with men, Myanmar.","HIV self-testing (HIVST) shows promise to improve HIV diagnosis among those seeking privacy and anonymity in HIV testing. This may include sexual and gender diverse populations, who experience disproportionately high burdens of stigma and HIV globally. To inform potential scale-up of HIVST in Myanmar, we implemented a community-led, mixed-methods randomized trial in Yangon. Adult trans-feminine individuals and cisgender men who have sex with men were recruited via respondent-driven sampling. Participants ( N  =   577) completed a baseline survey and were randomized to community-based HIV testing services (HTS) or HIVST. One-third of participants reported lifetime HIV testing. Over half (59.4%) returned for a second study visit to report their test result and test acceptability, which was lower among HTS-assigned participants compared to those assigned to HIVST (55.6% vs. 63.1%;  p  =   0.096). Participants reported that both HIVST and HTS were easy to access, test, and interpret/understand the results of their HIV test. Ninety percent of HTS-assigned participants indicated they would test regularly if they could access HIVST. Qualitative participants ( N  =   20) described that the convenience and privacy afforded by HIVST may increase the availability and coverage of testing. Taken together, these results suggest HIVST is an acceptable, low-barrier complement to community-based HTS for key populations in Myanmar.",2022,HIV self-testing (HIVST) shows promise to improve HIV diagnosis among those seeking privacy and anonymity in HIV testing.,"['transgender women and men who have sex with men, Myanmar', 'Adult trans-feminine individuals and cisgender men who have sex with men were recruited via respondent-driven sampling', 'Participants ( N\u2009 = \u2009 577) completed a baseline survey']","['HIVST', 'HIV self-testing (HIVST', 'community-based HIV testing services (HTS) or HIVST', 'HIV self-testing']","['lifetime HIV testing', 'availability and coverage of testing']","[{'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",,0.283456,HIV self-testing (HIVST) shows promise to improve HIV diagnosis among those seeking privacy and anonymity in HIV testing.,"[{'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Wirtz', 'Affiliation': 'Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MA, USA.'}, {'ForeName': 'Soe', 'Initials': 'S', 'LastName': 'Naing', 'Affiliation': 'MAHAMATE (Alliance Myanmar), Yangon, Myanmar.'}, {'ForeName': 'Sandra Hsu Hnin', 'Initials': 'SHH', 'LastName': 'Mon', 'Affiliation': 'Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MA, USA.'}, {'ForeName': 'Aung Zayar', 'Initials': 'AZ', 'LastName': 'Paing', 'Affiliation': 'MAHAMATE (Alliance Myanmar), Yangon, Myanmar.'}, {'ForeName': 'Ei Khine', 'Initials': 'EK', 'LastName': 'Mon', 'Affiliation': 'MAHAMATE (Alliance Myanmar), Yangon, Myanmar.'}, {'ForeName': 'Kaung Htet', 'Initials': 'KH', 'LastName': 'Thu', 'Affiliation': 'MAHAMATE (Alliance Myanmar), Yangon, Myanmar.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'M Truong', 'Affiliation': 'Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MA, USA.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Jivapong', 'Affiliation': 'Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Clouse', 'Affiliation': 'Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MA, USA.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Baral', 'Affiliation': 'Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Beyrer', 'Affiliation': 'Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MA, USA.'}]",AIDS care,['10.1080/09540121.2021.2005763']
280,34806246,Dropout in brief psychotherapy for major depressive disorder: Randomized clinical trial.,"The aim of this paper is to analyse the factors associated with the dropout from brief psychotherapy for adults with major depressive disorder (MDD) treated at a mental health outpatient clinic. This is a randomized clinical trial with two models of psychotherapy: cognitive behavioural therapy (CBT) and supportive expressive dynamic psychotherapy (SEDP). MDD and anxiety disorders were evaluated through the Mini International Neuropsychiatric Interview-Plus. The personality disorders were evaluated by the Millon Clinical Multiaxial Inventory-III. The severity of depressive symptoms was measured using the Beck Depression Inventory-II and resilience through Resilience Scale. Of the 215 participants, 41.9% abandoned psychotherapy (n = 90), and, of these, 54.4% (n = 49) abandoned after the fourth session. The proportion of psychotherapy dropout was higher among those with nonwhite skin colour, belonging to economic classes C and D, who had children and whose depressive symptoms were moderate. Presence of obsessive-compulsive personality trait was protective against dropout. The damage caused by this abrupt interruption is evident for all those involved in the psychotherapeutic process, so the clinician should pay attention to the predictors found in this study in order to develop strategies that promote therapeutic adherence.",2022,"The proportion of psychotherapy dropout was higher among those with non-white skin color, belonging to economic classes C and D, who had children and whose depressive symptoms were moderate.","['215 participants, 41.9% abandoned psychotherapy (n=90), and, of these, 54,4% (n=49) abandoned after the fourth session', 'Major Depressive Disorder', 'adults with Major Depressive Disorder (MDD) treated at a mental health outpatient clinic']","['psychotherapy', 'psychotherapy: Cognitive Behavioral Therapy (CBT) and Supportive Expressive Dynamic Psychotherapy (SEDP']","['Beck Depression Inventory-II and resilience through Resilience Scale', 'depressive symptoms', 'severity of depressive symptoms', 'MDD and Anxiety Disorders', 'proportion of psychotherapy dropout']","[{'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C1272694', 'cui_str': 'Abandoned'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]",215.0,0.0285174,"The proportion of psychotherapy dropout was higher among those with non-white skin color, belonging to economic classes C and D, who had children and whose depressive symptoms were moderate.","[{'ForeName': 'Rosiene', 'Initials': 'R', 'LastName': 'da Silva Machado', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Igor Soares', 'Initials': 'IS', 'LastName': 'Vieira', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Thaise C', 'Initials': 'TC', 'LastName': 'Mondin', 'Affiliation': 'Pró-Reitoria de Assuntos Estudantis, Universidade Federal de Pelotas (UFPel), Pelotas, Brazil.'}, {'ForeName': 'Carolina Rheingantz', 'Initials': 'CR', 'LastName': 'Scaini', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Mariane Lopez', 'Initials': 'ML', 'LastName': 'Molina', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jansen', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Luciano Dias', 'Initials': 'LD', 'LastName': 'de Mattos Souza', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Malu Ribeiro', 'Initials': 'MR', 'LastName': 'Duarte', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Simjanoski', 'Affiliation': 'Programa de Pós-Graduação em Neurociência, Universidade McMaster, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ricardo Azevedo', 'Initials': 'RA', 'LastName': 'da Silva', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas, Pelotas, Brazil.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2693']
281,34820727,Combined Primary Resection with Hepatic Artery Infusion Pump Implantation Is Safe for Unresectable Colorectal Liver Metastases.,"BACKGROUND


Colorectal liver metastases (CRLM) are the most common cause of disease-specific mortality in patients with colorectal cancer. Hepatic artery infusion (HAI) combined with systemic chemotherapy improves survival for these patients. The safety of colorectal resection at the time of HAI pump placement has not been well established.
METHODS


Patients with CRLM who underwent combined HAI pump placement and colorectal (primary) resection or HAI pump placement alone were evaluated for perioperative outcomes, pump-specific complications, infectious complications, and time to treatment initiation. These outcomes were compared using comparative statistics.
RESULTS


Patients who underwent combined HAI pump placement and primary resection (n = 19) vs HAI pump placement alone (n = 13) had similar demographics and rates of combined hepatectomy. Combined HAI pump placement and primary resection group had similar operative time and blood loss (both p = NS), but longer length of stay (6 vs 4 days, p = 0.02) compared to pump placement alone. Overall postoperative complications (21% vs 8%) and pump-specific complications (16% vs 31%) were similar (both p = NS). Infection rates were not different between groups, nor was time to initiation of HAI therapy (19 vs 16 days p = NS), or systemic therapy (34 vs 35 days p = NS).
CONCLUSION


Combining colorectal resection with HAI pump implantation is a safe surgical approach for management of unresectable CRLM. Postoperative complications, specifically infectious complications, were not increased, nor was there a delay to initiation of HAI or systemic chemotherapy. Investigation of long-term oncologic outcomes for HAI pump placement and primary tumor resection in patients with unresectable CRLM is ongoing.",2022,"Combined HAI pump placement and primary resection group had similar operative time and blood loss (both p = NS), but longer length of stay (6 vs 4 days, p = 0.02) compared to pump placement alone.","['Unresectable Colorectal Liver Metastases', 'patients with colorectal cancer', 'Patients with CRLM who underwent', 'patients with unresectable CRLM is ongoing']","['Combined Primary Resection with Hepatic Artery Infusion Pump Implantation', 'combined HAI pump placement and colorectal (primary) resection or HAI pump placement alone', 'HAI pump implantation', 'HAI pump placement', 'Combined HAI pump placement', 'Hepatic artery infusion (HAI) combined with systemic chemotherapy']","['operative time and blood loss', 'longer length of stay', 'Infection rates', 'Overall postoperative complications', 'survival', 'pump-specific complications', 'Postoperative complications, specifically infectious complications', 'delay to initiation of HAI or systemic chemotherapy']","[{'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0019145', 'cui_str': 'Hepatic artery'}, {'cui': 'C0021436', 'cui_str': 'Infusion pump'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0019145', 'cui_str': 'Hepatic artery'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.101178,"Combined HAI pump placement and primary resection group had similar operative time and blood loss (both p = NS), but longer length of stay (6 vs 4 days, p = 0.02) compared to pump placement alone.","[{'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Turley', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Creasy', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Sharib', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Lan', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'Julie K M', 'Initials': 'JKM', 'LastName': 'Thacker', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Migaly', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'Zani', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Allen', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Mantyh', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Lidsky', 'Affiliation': 'Department of Surgery, Duke University Medical Center, 2301 Erwin Road, 7HAFS, Durham, NC, 27705, USA.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-021-05195-8']
282,34820818,[For Which Patients is Web-Based Psychotherapeutic Aftercare after Psychosomatic Rehabilitation Most Suitable?],"OBJECTIVE


In order to maintain the effects achieved during the psychosomatic rehabilitation, according aftercare is indicated for most rehabilitation patients. Due to the current low supply of aftercare psychotherapists (so-called aftercare therapists) licensed by the German Pension Insurance web-based aftercare provides an equivalent alternative to analogue (in person) offers. This study clarifies which characteristics indicate that web-based aftercare is particularly recommended and how web-based formats are evaluated by participants, especially with regard to the therapeutic relationship.
METHODS


142 psychosomatic rehabilitation patients were randomly assigned to analogue aftercare or web-based aftercare if a service close to their home was available (equivalence study design). Test variables were collected by questionnaires and analyzed stratified for age and gender.
RESULTS


For male participants, there are no significant differences between the two aftercare formats. Women appear to have lower long-term depression scores when participating in web-based aftercare. Participants till the age 50 benefit significantly more from web-based aftercare than rehabilitants above age 50, The quality of the therapeutic relationship is rated equally well in both aftercare formats.
DISCUSSION


Particularly in view of the increasing digitization of healthcare in times of the corona pandemic, web-based aftercare services offer the possibility of providing patients with aftercare independent of the availability of analogue-services and with the same benefits as analog therapies. Demographic factors such as age and sex must be taken into account when determining the indication.
CONCLUSION


Therapists should recommend web-based aftercare especially for younger patients and for women, while men and older patients can be recommended both services equally. Therapists who offer web-based aftercare should be trained in advance on technical and content-related aspects, as was done in the present work.",2022,"Participants till the age 50 benefit significantly more from web-based aftercare than rehabilitants above age 50, The quality of the therapeutic relationship is rated equally well in both aftercare formats.
","['142 psychosomatic rehabilitation patients', 'male participants']",['analogue aftercare or web-based aftercare if a service close to their home'],['lower long-term depression scores'],"[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",142.0,0.0217629,"Participants till the age 50 benefit significantly more from web-based aftercare than rehabilitants above age 50, The quality of the therapeutic relationship is rated equally well in both aftercare formats.
","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Dahmen', 'Affiliation': 'Klinikum Wolfsburg, Deutschland.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Psychology & Methods, Jacobs University Bremen, Bremen, Deutschland.'}, {'ForeName': 'Franziska Maria', 'Initials': 'FM', 'LastName': 'Keller', 'Affiliation': 'Psychology & Methods, Jacobs University Bremen, Bremen, Deutschland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Becker', 'Affiliation': 'Dr Becker Hospital Group, Köln, Deutschland.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Lippke', 'Affiliation': 'Psychology & Methods, Jacobs University Bremen, Bremen, Deutschland.'}]","Psychotherapie, Psychosomatik, medizinische Psychologie",['10.1055/a-1663-6747']
283,34811509,Effect of pecan nuts and extra-virgin olive oil on glycemic profile and nontraditional anthropometric indexes in patients with coronary artery disease: a randomized clinical trial.,"BACKGROUND/OBJECTIVES


The influence of cardioprotective foods on nontraditional indexes related to dysglycemia and body fat distribution is unknown in individuals with coronary artery disease (CAD). This study aimed to evaluate the effect of a healthy diet supplemented with pecan nuts or extra-virgin olive oil on glycemic profile and adipose tissue dysfunction assessed by anthropometric indexes in patients with stable CAD.
SUBJECTS/METHODS


In a randomized, pragmatic, parallel clinical trial lasting 12 weeks, 204 individuals were allocated to three interventions: a healthy diet (control group [CG], n = 67), a healthy diet plus 30 g/day of pecan nuts (pecan nut group [PNG], n = 68), or a healthy diet plus 30 mL/day of extra-virgin olive oil (olive oil group [OOG], n = 69). Triglyceride-glucose (TyG) index (primary outcome) and other markers of glycemic profile were evaluated, and nontraditional anthropometric indexes as well. Diet quality was assessed according to the Alternate Healthy Eating Index (mAHEI).
RESULTS


After adjustment for baseline values, use of antidiabetic drugs and insulin, there were no differences in both glycemic and anthropometric profiles according to groups at the end of the study. PNG improved the quality of the diet in comparison to other groups (final mAHEI scores: CG: 19 ± 7.5; PNG: 26 ± 8; OOG: 18.9 ± 6; P < 0.001).
CONCLUSIONS


There was no difference regarding glycemic and anthropometric parameters according to interventions in patients with stable CAD. However, adding pecan nuts to a healthy diet may improve its quality. Further studies must be conducted considering dietary interventions on secondary cardiovascular prevention setting.
CLINICAL TRIALS IDENTIFIER NUMBER


NCT02202265. First Posted: July 2014; Last Update: September 2020.",2022,"After adjustment for baseline values, use of antidiabetic drugs and insulin, there were no differences in both glycemic and anthropometric profiles according to groups at the end of the study.","['individuals with coronary artery disease (CAD', '204 individuals', 'patients with coronary artery disease', 'patients with stable CAD']","['healthy diet supplemented with pecan nuts or extra-virgin olive oil', 'healthy diet (control group [CG], n\u2009=\u200967), a healthy diet plus 30\u2009g/day of pecan nuts (pecan nut group [PNG], n\u2009=\u200968), or a healthy diet plus 30\u2009mL/day of extra-virgin olive oil (olive oil group [OOG', 'pecan nuts and extra-virgin olive oil', 'cardioprotective foods']","['Triglyceride-glucose (TyG) index (primary outcome) and other markers of glycemic profile', 'glycemic and anthropometric parameters', 'glycemic profile and adipose tissue dysfunction', 'Diet quality', 'glycemic profile and nontraditional anthropometric indexes', 'Alternate Healthy Eating Index (mAHEI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0440289', 'cui_str': 'Pecan nut'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}]",204.0,0.0362341,"After adjustment for baseline values, use of antidiabetic drugs and insulin, there were no differences in both glycemic and anthropometric profiles according to groups at the end of the study.","[{'ForeName': 'Júlia L', 'Initials': 'JL', 'LastName': 'Dos Santos', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Vera L', 'Initials': 'VL', 'LastName': 'Portal', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Markoski', 'Affiliation': 'Graduate Program in Biosciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Alexandre S', 'Initials': 'AS', 'LastName': 'de Quadros', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Ângela', 'Initials': 'Â', 'LastName': 'Bersch-Ferreira', 'Affiliation': 'HCor Research Institute, Hospital do Coração (IP-HCor), São Paulo, Brazil.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Marcadenti', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul (IC/FUC), Porto Alegre, Brazil. marcadenti.aline@gmail.com.'}]",European journal of clinical nutrition,['10.1038/s41430-021-01045-7']
284,34817543,Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF): A Pilot Randomized Clinical Trial.,"IMPORTANCE


Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma.
OBJECTIVE


To determine whether patient-led surveillance in patients with prior localized primary cutaneous melanoma is as safe, feasible, and acceptable as clinician-led surveillance.
DESIGN, SETTING, AND PARTICIPANTS


This was a pilot for a randomized clinical trial at 2 specialist-led clinics in metropolitan Sydney, Australia, and a primary care skin cancer clinic managed by general practitioners in metropolitan Newcastle, Australia. The participants were 100 patients who had been treated for localized melanoma, owned a smartphone, had a partner to assist with skin self-examination (SSE), and had been routinely attending scheduled follow-up visits. The study was conducted from November 1, 2018, to January 17, 2020, with analysis performed from September 1, 2020, to November 15, 2020.
INTERVENTION


Participants were randomized (1:1) to 6 months of patient-led surveillance (the intervention comprised usual care plus reminders to perform SSE, patient-performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (the control was usual care).
MAIN OUTCOMES AND MEASURES


The primary outcome was the proportion of eligible and contacted patients who were randomized. Secondary outcomes included patient-reported outcomes (eg, SSE knowledge, attitudes, and practices, psychological outcomes, other health care use) and clinical outcomes (eg, clinic visits, skin surgeries, subsequent new primary or recurrent melanoma).
RESULTS


Of 326 patients who were eligible and contacted, 100 (31%) patients (mean [SD] age, 58.7 [12.0] years; 53 [53%] men) were randomized to patient-led (n = 49) or clinician-led (n = 51) surveillance. Data were available on patient-reported outcomes for 66 participants and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance was associated with increased SSE frequency (odds ratio [OR], 3.5; 95% CI, 0.9 to 14.0) and thoroughness (OR, 2.2; 95% CI, 0.8 to 5.7), had no detectable adverse effect on psychological outcomes (fear of cancer recurrence subscale score; mean difference, -1.3; 95% CI, -3.1 to 0.5), and increased clinic visits (risk ratio [RR], 1.5; 95% CI, 1.1 to 2.1), skin lesion excisions (RR, 1.1; 95% CI, 0.6 to 2.0), and subsequent melanoma diagnoses and subsequent melanoma diagnoses (risk difference, 10%; 95% CI, -2% to 23%). New primary melanomas and 1 local recurrence were diagnosed in 8 (16%) of the participants in the intervention group, including 5 (10%) ahead of routinely scheduled visits; and in 3 (6%) of the participants in the control group, with none (0%) ahead of routinely scheduled visits (risk difference, 10%; 95% CI, 2% to 19%).
CONCLUSIONS AND RELEVANCE


This pilot of a randomized clinical trial found that patient-led surveillance after treatment of localized melanoma appears to be safe, feasible, and acceptable. Experiences from this pilot study have prompted improvements to the trial processes for the larger trial of the same intervention.
TRIAL REGISTRATION


http://anzctr.org.au Identifier: ACTRN12616001716459.",2022,"New primary melanomas and 1 local recurrence were diagnosed in 8 (16%) of the participants in the intervention group, including 5 (10%) ahead of routinely scheduled visits; and in 3 (6%) of the participants in the control group, with none (0%) ahead of routinely scheduled visits (risk difference, 10%; 95% CI, 2% to 19%).
","['2 specialist-led clinics in metropolitan Sydney, Australia, and a primary care skin cancer clinic managed by general practitioners in metropolitan Newcastle, Australia', '326 patients who were eligible and contacted, 100 (31%) patients (mean [SD] age', 'patients with prior localized primary cutaneous melanoma', 'November 1, 2018, to January 17, 2020, with analysis performed from September 1, 2020, to November 15, 2020', '66 participants and on clinical outcomes for 100 participants', '58.7 [12.0] years; 53 [53%] men', 'participants were 100 patients who had been treated for localized melanoma, owned a smartphone, had a partner to assist with skin self-examination (SSE), and had been routinely attending scheduled follow-up visits']","['patient-led surveillance (the intervention comprised usual care plus reminders to perform SSE, patient-performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (the control was usual care', 'Localized Melanoma (MEL-SELF']","['clinic visits', 'patient-reported outcomes (eg, SSE knowledge, attitudes, and practices, psychological outcomes, other health care use) and clinical outcomes (eg, clinic visits, skin surgeries, subsequent new primary or recurrent melanoma', 'skin lesion excisions', 'subsequent melanoma diagnoses and subsequent melanoma diagnoses', 'local recurrence', 'psychological outcomes (fear of cancer recurrence subscale score', 'SSE frequency']","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0027983', 'cui_str': 'Newcastle disease'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}, {'cui': 'C1449565', 'cui_str': 'Dermatoscopy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0939937', 'cui_str': 'Honey preparation'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3266910', 'cui_str': 'Cutaneous Surgical Procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0278884', 'cui_str': 'Melanoma recurrent'}, {'cui': 'C0191322', 'cui_str': 'Excision of lesion of skin'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",100.0,0.609537,"New primary melanomas and 1 local recurrence were diagnosed in 8 (16%) of the participants in the intervention group, including 5 (10%) ahead of routinely scheduled visits; and in 3 (6%) of the participants in the control group, with none (0%) ahead of routinely scheduled visits (risk difference, 10%; 95% CI, 2% to 19%).
","[{'ForeName': 'Deonna M', 'Initials': 'DM', 'LastName': 'Ackermann', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mbathio', 'Initials': 'M', 'LastName': 'Dieng', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Medcalf', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marisa C', 'Initials': 'MC', 'LastName': 'Jenkins', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Cathelijne H', 'Initials': 'CH', 'LastName': 'van Kemenade', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Janda', 'Affiliation': 'Centre for Health Services Research, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Turner', 'Affiliation': 'Biostatistics Centre, University of Otago, Dunedin, Otago, New Zealand.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Cust', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Morton', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Irwig', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Guitera', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'H Peter', 'Initials': 'HP', 'LastName': 'Soyer', 'Affiliation': 'Dermatology Research Centre, The University of Queensland Diamantina Institute, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Mar', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jolyn K', 'Initials': 'JK', 'LastName': 'Hersch', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Low', 'Affiliation': 'Cancer Voices New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Low', 'Affiliation': 'Cancer Voices New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robyn P M', 'Initials': 'RPM', 'LastName': 'Saw', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Scolyer', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Drabarek', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Espinoza', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Azzi', 'Affiliation': 'Newcastle Skin Check, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Alister M', 'Initials': 'AM', 'LastName': 'Lilleyman', 'Affiliation': 'Newcastle Skin Check, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Amelia K', 'Initials': 'AK', 'LastName': 'Smit', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Murchie', 'Affiliation': 'Academic Primary Care Research Group, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, United Kingdom.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Thompson', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katy J L', 'Initials': 'KJL', 'LastName': 'Bell', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}]",JAMA dermatology,['10.1001/jamadermatol.2021.4704']
285,34819347,Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants.,"OBJECTIVE


Automatic control (SPOC) of the fraction of inspired oxygen (FiO 2 ), based on continuous analysis of pulse oximeter saturation (SpO 2 ), improves the proportion of time preterm infants spend within a specified SpO 2 -target range (Target%). We evaluated if a revised SPOC algorithm (SPOC new , including an upper limit for FiO 2 ) compared to both routine manual control (RMC) and the previously tested algorithm (SPOC old,  unrestricted maximum FiO 2 ) increases Target%, and evaluated the effect of the pulse oximeter's averaging time on controlling the SpO 2  signal during SPOC periods.
DESIGN


Unblinded, randomised controlled crossover study comparing 2 SPOC algorithms and 2 SpO 2  averaging times in random order: 12 hours SPOC new  and 12 hours SPOC old  (averaging time 2 s or 8 s for 6 hours each) were compared with 6-hour RMC. A generated list of random numbers was used for allocation sequence.
SETTING


University-affiliated tertiary neonatal intensive care unit, Germany PATIENTS: Twenty-four infants on non-invasive respiratory support with FiO 2  >0.21 were analysed (median gestational age at birth, birth weight and age at randomisation were 25.3 weeks, 585 g and 30 days).
MAIN OUTCOME MEASURE


Target%.
RESULTS


Mean (SD) [95% CI] Target% was 56% (9) [52, 59] for RMC versus 69% (9) [65, 72] for SPOC old _ 2s , 70% (7) [67, 73] for SPOC new _ 2s , 71% (8) [68, 74] for SPOC old _ 8s  and 72% (8) [69, 75] for SPOC new _ 8s .
CONCLUSIONS


Irrespective of SpO 2 -averaging time, Target% was higher with both SPOC algorithms compared to RMC. Despite limiting the maximum FiO 2 , SPOC new  remained significantly better at maintaining SpO 2  within target range compared to RMC.
TRIAL REGISTRATION


NCT03785899.",2022,"Despite limiting the maximum FiO 2 , SPOC new  remained significantly better at maintaining SpO 2  within target range compared to RMC.
","['University-affiliated tertiary neonatal intensive care unit', 'preterm infants', ' Twenty-four infants on non-invasive respiratory support with FiO 2  >0.21 were analysed (median gestational age at birth, birth weight and age at randomisation were 25.3 weeks, 585\u2009g and 30 days', '2 SPOC algorithms and 2 SpO 2  averaging times in random order: 12\u2009hours SPOC new  and 12\u2009hours SPOC old  (averaging time 2']","['routine manual control (RMC', 'Automatic control (SPOC) of the fraction of inspired oxygen (FiO 2 ']",['Mean (SD'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4517437', 'cui_str': '0.21'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.103443,"Despite limiting the maximum FiO 2 , SPOC new  remained significantly better at maintaining SpO 2  within target range compared to RMC.
","[{'ForeName': 'Christoph E', 'Initials': 'CE', 'LastName': 'Schwarz', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.""}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Kreutzer', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany karen.kreutzer@med.uni-tuebingen.de.""}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Langanky', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.""}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Wolf', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Braun', 'Affiliation': 'Fritz Stephan GmbH, Gackenbach, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Marc Paul', 'Initials': 'MP', 'LastName': ""O'Sullivan"", 'Affiliation': 'INFANT Research Centre, Cork, Ireland.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Poets', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.""}, {'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Franz', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.""}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2021-322096']
286,34807347,Effects of active vitamin D on insulin resistance and islet β-cell function in non-diabetic chronic kidney disease patients: a randomized controlled study.,"PURPOSE


The purpose of the study is to observe the effects of active vitamin D supplementation on insulin resistance and islet β-cell function (HOMA-β) in patients with non-diabetic chronic kidney disease (NDCKD).
METHODS


A total of 134 patients with NDCKD who met the inclusion criteria were enrolled in the prospective controlled study and categorized as such: 60 patients in the non-dialysis (ND) group; 36, hemodialysis (HD) group; and 38, peritoneal dialysis (PD) group. Each group was divided into two equal-numbered subgroups for vitamin D supplementation. Those in the experimental subgroups received calcitriol 0.5 ug/day orally, and were followed-up for 6 months. A total of 117 patients were followed-up, including 57 patients in the ND group; 29, HD group; and 31, PD group. Changes in the insulin resistance index (HOMA-IR) and HOMA-β index were calculated and compared at the time of enrollment and after 1, 3, and 6 months of intervention.
RESULTS


(1) Mean HOMA-IR value: In the ND group, mean HOMA-IR value of the experimental group significantly decreased compared with that of the control group after 3 months of intervention (P = 0.02). In the HD and PD groups, there was no statistical difference between the experimental and control groups (P > 0.05). (2) Mean HOMA-β index: In the ND group, mean HOMA-β index of the experimental group was higher than that of the control group after 1 month of active vitamin D treatment (P = 0.03), and, with an extended intervention time, the index gradually increased (P < 0.001). In the HD group, mean HOMA-β index of the experimental group was higher than that of the control group after 3 months of active vitamin D treatment (P = 0.01). Among PD patients, mean HOMA-β index of the patients in the experimental group was higher than that of the control group after 6 months of active vitamin D treatment (P = 0.02).
CONCLUSIONS


Active vitamin D supplementation improved insulin resistance and HOMA-β after 6 months in ND patients, but only improved HOMA-β in the dialysis patients, with no significant effect on insulin resistance.",2022,"In the HD group, mean HOMA-β index of the experimental group was higher than that of the control group after 3 months of active vitamin D treatment (P = 0.01).","['134 patients with NDCKD who met the inclusion criteria were enrolled in the prospective controlled study and categorized as such: 60 patients in the non-dialysis (ND) group; 36, hemodialysis (HD) group; and 38, peritoneal dialysis (PD) group', 'patients with non-diabetic chronic kidney disease (NDCKD', 'non-diabetic chronic kidney disease patients', 'A total of 117 patients were followed-up, including 57 patients in the ND group; 29, HD group; and 31, PD group']","['active vitamin D', 'vitamin D supplementation', 'Active vitamin D supplementation', 'active vitamin D supplementation', 'calcitriol']","['insulin resistance and islet β-cell function (HOMA-β', 'insulin resistance and islet β-cell function', 'insulin resistance index (HOMA-IR) and HOMA-β index', 'mean HOMA-IR value', 'mean HOMA-β index', 'Mean HOMA-IR value', 'insulin resistance', 'insulin resistance and HOMA-β', 'Mean HOMA-β index']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",134.0,0.0553098,"In the HD group, mean HOMA-β index of the experimental group was higher than that of the control group after 3 months of active vitamin D treatment (P = 0.01).","[{'ForeName': 'Yongxin', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Nephrology, People's Hospital of Yuxi City, The Sixth Affiliated Hospital of Kunming Medical University, Yuxi City, 653100, Yunnan Province, China.""}, {'ForeName': ""Yi'an"", 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology, People's Hospital of Yuxi City, The Sixth Affiliated Hospital of Kunming Medical University, Yuxi City, 653100, Yunnan Province, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Nephrology, People's Hospital of Yuxi City, The Sixth Affiliated Hospital of Kunming Medical University, Yuxi City, 653100, Yunnan Province, China.""}, {'ForeName': 'Yongyan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Internal Medicine, Beicheng Health Center, Hongta District, Yuxi City, 653100, Yunnan Province, China.'}, {'ForeName': 'Jingrui', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology, People's Hospital of Yuxi City, The Sixth Affiliated Hospital of Kunming Medical University, Yuxi City, 653100, Yunnan Province, China.""}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Nephrology, People's Hospital of Yuxi City, The Sixth Affiliated Hospital of Kunming Medical University, Yuxi City, 653100, Yunnan Province, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Xiufang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Nephrology, People's Hospital of Yuxi City, The Sixth Affiliated Hospital of Kunming Medical University, Yuxi City, 653100, Yunnan Province, China.""}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Nephrology, People's Hospital of Yuxi City, The Sixth Affiliated Hospital of Kunming Medical University, Yuxi City, 653100, Yunnan Province, China.""}, {'ForeName': 'Zongwu', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ""Department of Nephrology, People's Hospital of Yuxi City, The Sixth Affiliated Hospital of Kunming Medical University, Yuxi City, 653100, Yunnan Province, China. tongzongwud@126.com.""}]",International urology and nephrology,['10.1007/s11255-021-02968-7']
287,34819261,Serratus Anterior Plane Block Versus Intercostal Block with Incision Infiltration in Robotic-Assisted Thoracoscopic Surgery: A Randomized Controlled Pilot Trial.,"OBJECTIVES


Patients undergoing robotic video-assisted thoracoscopic surgery (rVATS) report significant postoperative pain. Both the serratus anterior plane block (SAPB) and the surgical intercostal block (IB) (performed by a surgeon from within the thorax), along with incision infiltration (II), are distinct modalities that target the lateral cutaneous branches of intercostal nerves and are acceptable analgesic modalities in an enhanced recovery after rVATS surgery.
DESIGN


Prospective, double-blinded, randomized, controlled pilot trial with 65 patients to assess the difference in analgesia quality between the SAPB and IB+II in rVATS.
SETTING


Major academic teaching hospital.
PARTICIPANTS


The inclusion criteria included ASA physical status I-IV, ages 18-to-75 undergoing an elective, unilateral rVATS procedure.
INTERVENTIONS


Patients were randomized to receive either an ultrasound-guided SAPB at the end of their surgery, using a 20-mL mixture consisting of 10 mL of liposomal bupivacaine (133 mg) and 10 mL 0.25% bupivacaine, or IB+II, using a 20-mL mixture consisting of 10 mL of liposomal bupivacaine (133 mg) and 10 mL 0.5% bupivacaine prior to skin closure by the surgeon.
RESULTS


The primary outcome was the amount of postoperative opioid consumption in morphine milliequivalents [MME] during the first 24 hours after surgery. Secondary outcomes were time to first analgesic request, VAS scores at zero, two, six, 18, or 24 hours at rest, and PACU, ICU, or hospital lengths of stay (LOS). There were no differences in any outcomes between the groups.
CONCLUSIONS


Both SAPB and IB+II are comparable analgesic modalities for rVATS procedures.",2022,"There were no differences in any outcomes between the groups.
","['18-to-75 undergoing an elective, unilateral rVATS procedure', 'Major academic teaching hospital', 'Patients undergoing', '65 patients', 'The inclusion criteria included ASA physical status']","['ultrasound-guided SAPB', 'liposomal bupivacaine', 'Serratus Anterior Plane Block Versus Intercostal Block with Incision Infiltration in Robotic-Assisted Thoracoscopic Surgery', 'bupivacaine, or IB+II, using a 20-mL mixture consisting of 10 mL of liposomal bupivacaine', 'bupivacaine prior to skin closure by the surgeon', 'robotic video-assisted thoracoscopic surgery (rVATS']","['time to first analgesic request, VAS scores at zero, two, six, 18, or 24 hours at rest, and PACU, ICU, or hospital lengths of stay (LOS', 'amount of postoperative opioid consumption in morphine milliequivalents [MME', 'analgesia quality']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439152', 'cui_str': 'mEq'}, {'cui': 'C0066662', 'cui_str': '1,2,3,4,9,9-hexachloro-1,4,4a,5,8,8a-hexahydro-6- methyl-6,7-epoxy-1,4-methanonaphthalene'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",65.0,0.428138,"There were no differences in any outcomes between the groups.
","[{'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Pai', 'Affiliation': 'Mount Sinai West - Morningside Hospitals, Department of Anesthesiology, Perioperative and Pain Medicine, New York, USA. Electronic address: Poonampaibh@gmail.com.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Mount Sinai West - Morningside Hospitals, Department of Anesthesiology, Perioperative and Pain Medicine, New York, USA. Electronic address: Janet.hong@mountsinai.org.'}, {'ForeName': 'Annmarie', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'Mount Sinai West - Morningside Hospitals, Department of Anesthesiology, Perioperative and Pain Medicine, New York, USA. Electronic address: annmarietoma@gmail.com.'}, {'ForeName': 'Hung-Mo', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Anesthesiology, Perioperative and Pain Medicine, New York, USA. Electronic address: Hung-mo.lin@mountsinai.org.'}, {'ForeName': 'Yan H', 'Initials': 'YH', 'LastName': 'Lai', 'Affiliation': 'Mount Sinai West - Morningside Hospitals, Department of Anesthesiology, Perioperative and Pain Medicine, New York, USA. Electronic address: Yanxan@gmail.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.10.022']
288,34823444,Efficacy of continuous theta burst stimulation - repetitive trancranial magnetic stimulation on the orbito frontal cortex as an adjunct to naltrexone in patients of opioid use disorder and its correlation with serum BDNF levels: a sham-controlled study.,Background:  Opoid use disorder (OUD) is a global illness and reduction in craving by repeatative Transcranial Magnetic Stimulation (RTMS) is one of its management approaches. Orbito-frontal Cortex is implicated in the several behavioral aspects of substance use including craving. Brain derived neurotrophic factor (BDNF) has a critical role in addictive properties of drugs of use. Previous studies have shown significant improvement in craving with RTMS and demonstrated alterations of serum BDNF levels in various substance dependent individual associated with craving.  Aim:  To examine the efficacy of continuous Theta Burst Stimulation RTMS (CTBS-RTMS) over the right OFC as an adjunct to Naltrexone in patients of OUD and its correlation with serum BDNF levels.  Methods:  Forty patients with OUD were recruited with purposive sampling. At the end of detoxification CTBS -RTMS was applied by dividing them into two equal groups as active and sham group using alternate allocation. Obsessive compulsive drug use scale (OCDUS) was applied and serum BDNF level was measured overtime till the end of CTBS-RTMS session. Data was analyzed by SPSS version 25.  Results:  Both groups had shown significant reduction in craving (OCDUS score) and serum BDNF from the baseline to 14th session of the RTMS. But there was no significant difference when compared between the two groups. Significant correlation was observed between serum BDNF levels overtime with different clinical variables in active group.  Conclusion:  The study adds to the literature in building an understanding of how rTMS could be used in reducing cravings for opioids.,2022,Both groups had shown significant reduction in craving (OCDUS score) and serum BDNF from the baseline to 14th session of the RTMS.,"['patients of opioid use disorder and its correlation with serum BDNF levels', 'Forty patients with OUD were recruited with purposive sampling']","['continuous Theta Burst Stimulation RTMS (CTBS-RTMS', 'continuous theta burst stimulation - repetitive trancranial magnetic stimulation', 'naltrexone', 'Naltrexone']","['serum BDNF levels', 'serum BDNF levels overtime', 'Obsessive compulsive drug use scale (OCDUS', 'serum BDNF level', 'craving (OCDUS score) and serum BDNF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2961731', 'cui_str': 'Overtime'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0148598,Both groups had shown significant reduction in craving (OCDUS score) and serum BDNF from the baseline to 14th session of the RTMS.,"[{'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Ankit', 'Affiliation': 'Department of Psychiatry, Central Institute of Psychiatry, Ranchi, India.'}, {'ForeName': 'Basudeb', 'Initials': 'B', 'LastName': 'Das', 'Affiliation': 'Department of Psychiatry, Central Institute of Psychiatry, Ranchi, India.'}, {'ForeName': 'Pranjal', 'Initials': 'P', 'LastName': 'Dey', 'Affiliation': 'Department of Psychiatry, Central Institute of Psychiatry, Ranchi, India.'}, {'ForeName': 'Khitish Kumar', 'Initials': 'KK', 'LastName': 'Kshitiz', 'Affiliation': 'Department of Biochemistry, Central Institute of Psychiatry, Ranchi, India.'}, {'ForeName': 'Christoday Raja Jayant', 'Initials': 'CRJ', 'LastName': 'Khess', 'Affiliation': 'Department of Psychiatry, Central Institute of Psychiatry, Ranchi, India.'}]",Journal of addictive diseases,['10.1080/10550887.2021.2007716']
289,34838267,Effectiveness and safety of tacrolimus treatment for IgA nephropathy: A prospective cohort study.,"BACKGROUND


There is no a unified opinion in the treatment of IgA nephropathy. This prospective cohort study was to explore the effectiveness and safety of tacrolimus for treatment of IgA (Immunoglobulin A) nephropathy patients.
METHODS


In this study, we assigned 50 patients with biopsy-proven IgA nephropathy in a 1:1.5 ratio to receive oral tacrolimus or full-dose glucocorticoid for 6 months. All the patients had 24-h urine protein excretion≥2.0g/24h and estimated glomerular filtration rate≥50mL/min/1.73m 2 . Primary endpoint was rate of complete remission.
RESULTS


After 6 months of treatment, seven participants achieved complete remission in the tacrolimus group and twelve participants in the glucocorticoid group, the complete remission rate was 35% and 40%, respectively. There were not significantly differences between two groups (P=0.7). However, the serum creatinine level from baseline was an increase of 13±13.5μmol/L in the tacrolimus group and a decrease of 8.2±20μmol/L in the glucocorticoid group. When patients stopped taking tacrolimus for 3 months, creatinine level can almost fall to normal level. Thus, patients with renal insufficiency have a high incidence in the tacrolimus group.
CONCLUSIONS


Tacrolimus was noninferior to full-dose glucocorticoid in inducing proteinuria remission at 6 months. This suggested that those IgA nephropathy patients who are unwilling to full-dose glucocorticoid could consider tacrolimus, but need to pay attention to the impact on renal function.",2022,All the patients had 24-h urine protein excretion≥2.0g/24h and estimated glomerular filtration rate≥50mL/min/1.73m 2 .,"['IgA (Immunoglobulin A) nephropathy patients', '50 patients with biopsy-proven IgA nephropathy in a 1:1.5 ratio to receive', 'IgA nephropathy', 'patients with renal insufficiency have a high incidence in the tacrolimus group']","['oral tacrolimus or full-dose glucocorticoid', 'Tacrolimus', 'tacrolimus', 'glucocorticoid']","['complete remission', 'effectiveness and safety', 'Effectiveness and safety', 'rate of complete remission', 'serum creatinine level', 'creatinine level', 'proteinuria remission', 'complete remission rate']","[{'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0450340', 'cui_str': '1:1.5'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",50.0,0.0334838,All the patients had 24-h urine protein excretion≥2.0g/24h and estimated glomerular filtration rate≥50mL/min/1.73m 2 .,"[{'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Nephrology, the Second Affiliated Hospital of Nanchang University, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, the Second Affiliated Hospital of Nanchang University, China; Department of Hemodialysis, JiuJiang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Tianlun', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Hemodialysis, JiuJiang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Hemodialysis, JiuJiang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hemodialysis, JiuJiang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Gaosi', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Nephrology, the Second Affiliated Hospital of Nanchang University, China. Electronic address: gaosixu@163.com.'}]",Medicina clinica,['10.1016/j.medcli.2021.07.030']
290,34839962,Effect of whole-body vibration training on transcutaneous oxygen levels of the foot in patients with type 2 diabetes: A randomized controlled trial.,"Whole body vibration (WBV) has been suggested as improving skin and blood flow. This study aimed to determine the effect of exposure to WBV on levels of partial transcutaneous oxygen pressure (TcPO2) in the foot of patients with type 2 diabetes (T2D) within the metabolic control goals. A block randomized, open, two-arm, parallel and controlled clinical trial was conducted. Participants recruited from the Center of Comprehensive Care for the Patient with Diabetes were assessed at the National Institute of Rehabilitation, Mexico City. Control group underwent multidisciplinary care for T2D; experimental group, in addition to the comprehensive diabetes care, was exposed to WBV through an exercise program, attending three times a week for a period of 3 months. TcPO2 was measured in the feet of the participants at baseline and after 12 weeks. A sample of 50 volunteers with recently-diagnosed T2D and similar baseline characteristics (demographic, cardiovascular risk, presence of diabetic polyneuropathy, and indicators of glycemic control and TcPO2) was recruited. The experimental group (n = 27) showed a mean value of 47.7 ± 6.1 mmHg in TcPO2, significantly higher (p = 0.028) than the 44.3 ± 7.5 mmHg of control group (n = 23), at the end of intervention. In conclusion, exposure to WBV promoted an increase and a significant 3 mmHg difference in the foot TcPO2 levels between those subjects with T2D that underwent the 12-week exercise program and those not exposed to the treatment.",2022,"6.1 mmHg in TcPO2, significantly higher (p = 0.028) than the 44.3 ± ","['50 volunteers with recently-diagnosed T2D and similar baseline characteristics (demographic, cardiovascular risk, presence of diabetic polyneuropathy, and indicators of glycemic control and TcPO2) was recruited', 'Participants recruited from the Center of Comprehensive Care for the Patient with Diabetes were assessed at the National Institute of Rehabilitation, Mexico City', 'patients with type 2 diabetes (T2D) within the metabolic control goals', 'patients with type 2 diabetes']","['whole-body vibration training', 'Whole body vibration (WBV']","['partial transcutaneous oxygen pressure (TcPO2', 'transcutaneous oxygen levels', 'foot TcPO2 levels', 'TcPO2']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]",50.0,0.0298778,"6.1 mmHg in TcPO2, significantly higher (p = 0.028) than the 44.3 ± ","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rodríguez-Reyes', 'Affiliation': 'Laboratorio de Ortesis y Prótesis, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'García-Ulloa', 'Affiliation': 'Centro de Atención Integral del Paciente con Diabetes (CAIPaDi), Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Hernández-Jiménez', 'Affiliation': 'Centro de Atención Integral del Paciente con Diabetes (CAIPaDi), Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Alessi-Montero', 'Affiliation': 'Laboratorio de Análisis de Movimiento Humano e Ingeniería de Rehabilitación, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Núñez Carrera', 'Affiliation': 'Laboratorio de Análisis de Movimiento Humano e Ingeniería de Rehabilitación, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Rojas-Torres', 'Affiliation': 'Centro de Atención Integral del Paciente con Diabetes (CAIPaDi), Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Infanzón-Talango', 'Affiliation': 'Centro de Atención Integral del Paciente con Diabetes (CAIPaDi), Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Clark', 'Affiliation': 'Unidad de Epidemiología Clínica, Hospital Infantil de México Federico Gómez and National University of Mexico-UNAM, Mexico City, Mexico.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Miranda-Duarte', 'Affiliation': 'Laboratorio de Genética, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Rita A', 'Initials': 'RA', 'LastName': 'Gómez-Díaz', 'Affiliation': 'Unidad de Investigación Médica en Epidemiología Clínica, UMAE Hospital de Especialidades, Centro Médico Nacional Siglo XXI. Instituto Mexicano del Seguro Social, Mexico City, Mexico. Electronic address: ritagomezdiaz@yahoo.com.mx.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2021.110871']
291,34838412,"Efficacy of DiaLife, an Education Program for Relatives of Adults with Diabetes - A Cluster Randomized Controlled Trial.","OBJECTIVE


Diabetes affects the lives of patients and their close relatives. Considering the proven benefit of patient education programs, DiaLife was elaborated as the first German education program addressing the needs of relatives. The objective of this study was to investigate its efficacy.
METHODS


The evaluation was implemented in the form of a cRCT with longitudinal design and waiting list condition.In total, 179 relatives were recruited. Participants' diabetes-related knowledge was defined as the primary outcome. Diabetes-related strains, family interaction and other psychosocial factors were determined as secondary outcomes.
RESULTS


A generalized estimating equation model showed a persistent increase of diabetes-related knowledge in the intervention group compared to the control group regardless of the type of diabetes. Concerning secondary outcomes, mixed linear models showed an improvement for relatives of people with type 2 diabetes who participated in the DiaLife program.
CONCLUSION


This study provides evidence of DiaLife's efficacy regarding a persistent increase of diabetes-related knowledge and a positive effect on psychosocial outcomes in relatives of people with type 2 but not in type 1 diabetes. Adding (an)other psychosocial module(s) might improve their well-being and psychosocial outcomes.
PRACTICE IMPLICATIONS


Diabetes centers should consider implementing an education program for relatives, such as DiaLife, in their curriculum.
TRIAL REGISTRATION


The study was registered at the German Clinical Trials Register (DRKS00015157; date of registration: 24.08.2018).",2022,"RESULTS


A generalized estimating equation model showed a persistent increase of diabetes-related knowledge in the intervention group compared to the control group regardless of the type of diabetes.","['Diabetes centers', 'In total, 179 relatives were recruited', 'relatives of people with type 2 but not in type 1 diabetes', 'Relatives of Adults with Diabetes ']",['DiaLife'],['diabetes-related knowledge'],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",179.0,0.0710802,"RESULTS


A generalized estimating equation model showed a persistent increase of diabetes-related knowledge in the intervention group compared to the control group regardless of the type of diabetes.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bernard', 'Affiliation': 'SRH University of Applied Health Sciences, Neue Straße 28-30, 07548 Gera, Germany; Institute of Medical Sociology (IMS), Medical Faculty, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8 - 06112 Halle (Saale), Germany. Electronic address: marie.bernard@medizin.uni-halle.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'University Hospital Jena, Center for Clinical Studies, Salvador-Allende-Platz 27, 07747 Jena, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hecht', 'Affiliation': 'VDBD e.V. - German Association of Diabetes Nurses and Education Experts, Habersaathstr. 31, 10115 Berlin, Germany; VDBD AKADEMIE GmbH, Habersaathstr. 31, 10115 Berlin, Germany; Institute for Research and Education in Diabetes (RED), Markt 15, 23758 Oldenburg, Germany.'}, {'ForeName': 'Gottlobe', 'Initials': 'G', 'LastName': 'Fabisch', 'Affiliation': 'VDBD e.V. - German Association of Diabetes Nurses and Education Experts, Habersaathstr. 31, 10115 Berlin, Germany; VDBD AKADEMIE GmbH, Habersaathstr. 31, 10115 Berlin, Germany.'}, {'ForeName': 'Asja', 'Initials': 'A', 'LastName': 'Harder', 'Affiliation': 'VDBD e.V. - German Association of Diabetes Nurses and Education Experts, Habersaathstr. 31, 10115 Berlin, Germany.'}, {'ForeName': 'Nicolle', 'Initials': 'N', 'LastName': 'Müller', 'Affiliation': 'University Hospital Jena, Department of Internal Medicine III, Am Klinikum 1, 07747 Jena, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Luck-Sikorski', 'Affiliation': 'SRH University of Applied Health Sciences, Neue Straße 28-30, 07548 Gera, Germany; Helmholtz Zentrum München, German Research Center for Environmental Health, Helmholtz Institute for Metabolic, Obesity and Vascular Research (HI-MAG), Philipp-Rosenthal-Straße 27, 04103 Leipzig, Germany.'}]",Patient education and counseling,['10.1016/j.pec.2021.11.013']
292,34840294,Polidocanol Foam Sclerotherapy Versus Rubber Band Ligation in Hemorrhoidal Disease Grades I/II/III: Randomized Trial.,"BACKGROUND


Rubber band ligation and sclerotherapy are considered the office-based procedures of choice in hemorrhoidal disease. However, there are no studies comparing rubber band ligation and polidocanol foam sclerotherapy.
OBJECTIVE


We aimed to evaluate the efficacy and safety of polidocanol foam sclerotherapy compared with rubber band ligation.
DESIGN


This study was a randomized open-label study with 1-year follow-up.
SETTINGS


The study was conducted in the colorectal unit of a tertiary hospital.
PATIENTS


One hundred twenty patients with hemorrhoidal disease grades I to III were included.
INTERVENTIONS


Patients were stratified by hemorrhoidal disease grade and randomly assigned (1:1) to treatment with either rubber band ligation (n = 60) or polidocanol foam sclerotherapy (n = 60).
MAIN OUTCOME MEASURES


Efficacy outcomes included therapeutic success and recurrence. Safety outcomes included the occurrence of complications related to the procedures.
RESULTS


Therapeutic success was not significantly different between the groups (polidocanol foam sclerotherapy 93.3% vs rubber band ligation 85.0%, p = 0.14). However, complete success rate was higher in the polidocanol foam sclerotherapy group (88.3% vs 66.7%, p = 0.009) with fewer office-based sessions (mean ± SD: 1.32 ± 0.60 vs 1.62 ± 0.76, p = 0.02). Recurrence rates were lower in the polidocanol foam sclerotherapy group (16.1% vs 41.2%, p = 0.004). Most recurrences were mild (83.3%). Complications were more frequent in the rubber band ligation group (30.0% vs 10.0%, p = 0.01) and were mostly minor (91.7%). No severe complications were observed in either group.
LIMITATIONS


This study was performed in a single center, and both patients and investigators were not blinded to the treatment group.
CONCLUSIONS


Both procedures are effective in the treatment of hemorrhoidal disease grades I to III. Polidocanol foam sclerotherapy was more effective than rubber band ligation when considering complete success. Patients in the polidocanol foam sclerotherapy group needed fewer treatment sessions, had lower recurrence rates, and were less likely to have complications. See Video Abstract at http://links.lww.com/DCR/B816.
REGISTRATION


https//www.clinicaltrials.gov; Identifier: NCT04091763.
ESCLEROTERAPIA CON ESPUMA DE POLIDOCANOL VERSUS LIGADURA CON BANDA DE GOMA EN LOS GRADOS I / II / III DE ENFERMEDAD HEMORROIDAL ENSAYO ALEATORIZADO


ANTECEDENTES:La ligadura con banda elástica y la escleroterapia se consideran los procedimientos de elección en el consultorio para la enfermedad hemorroidal. Sin embargo, no hay estudios que comparen la ligadura con bandas elastica y la escleroterapia con espuma de polidocanol.OBJETIVO:Nuestro objetivo fue evaluar la eficacia y seguridad de la escleroterapia con espuma de polidocanol en comparación con la ligadura con bandas elastica.DISEÑO:Estudio aleatorizado randomizado, abierto, con seguimiento de 1 año.AJUSTES:El estudio se realizó en una unidad colorrectal de un hospital terciario.PACIENTES:Se incluyeron 120 pacientes con enfermedad hemorroidal grados I a III.INTERVENCIONES:Los pacientes fueron estratificados por grado de enfermedad hemorroidal y asignados al azar (1: 1) al tratamiento con ligadura con banda elastica (n = 60) o escleroterapia con espuma de polidocanol (n = 60).PRINCIPALES MEDIDAS DE RESULTADO:Los resultados de eficacia incluyeron el éxito terapéutico y la recurrencia. Los resultados de seguridad incluyeron la aparición de complicaciones relacionadas con los procedimientos.RESULTADOS:El éxito terapéutico no fue significativamente diferente entre los grupos (escleroterapia con espuma de polidocanol 93,3% vs ligadura con banda de goma 85,0%, p = 0,14). Sin embargo, la tasa de éxito completo fue mayor en el grupo de escleroterapia con espuma de polidocanol (88,3% vs 66,7%, p = 0,009), con menos sesiones en el consultorio (media ± desviación estándar: 1,32 ± 0,60 vs 1,62 ± 0,76, p = 0,02). Las tasas de recurrencia fueron más bajas en el grupo de escleroterapia con espuma de polidocanol (16,1% vs 41,2%, p = 0,004). La mayoría de las recurrencias fueron leves (83,3%). Las complicaciones fueron más frecuentes en el grupo de ligadura con bandas elastica (30,0% vs 10,0%, p = 0,01) y fueron en su mayoría menores (91,7%). No se observaron complicaciones graves en ninguno de los grupos.LIMITACIONES:Este estudio se realizó en un solo centro y ni los pacientes ni los investigadores estaban cegados al grupo de tratamiento.CONCLUSIONES:Ambos procedimientos son efectivos en el tratamiento de la enfermedad hemorroidal grados I a III. La escleroterapia con espuma de polidocanol fue más eficaz que la ligadura con banda de goma cuando se consideró el éxito completo. Los pacientes del grupo de escleroterapia con espuma de polidocanol necesitaron menos sesiones de tratamiento, tuvieron tasas de recurrencia más bajas y menos probabilidades de tener complicaciones. Consulte Video Resumen en http://links.lww.com/DCR/B816. (Traducción-Dr Yolanda Colorado)ClinicalTrials.gov, número NCT04091763.",2022,"Patients in the polidocanol foam sclerotherapy group needed fewer treatment sessions, had lower recurrence rates and were less likely to have complications.","['One hundred twenty patients with hemorrhoidal disease grades', 'colorectal unit of a tertiary hospital', 'Hemorrhoidal Disease Grades']","['Polidocanol Foam Sclerotherapy Versus Rubber Band Ligation', 'polidocanol foam sclerotherapy', 'Rubber band ligation and sclerotherapy', 'Polidocanol foam sclerotherapy', 'polidocanol', 'rubber band ligation']","['complete success rate', 'occurrence of complications related to the procedures', 'Therapeutic success', 'severe complications', 'Complications', 'recurrence rates', 'efficacy and safety', 'therapeutic success and recurrence', 'Recurrence rates']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.132481,"Patients in the polidocanol foam sclerotherapy group needed fewer treatment sessions, had lower recurrence rates and were less likely to have complications.","[{'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Salgueiro', 'Affiliation': 'Department of Gastroenterology, Hospital de Santo António, Centro Hospitalar Universitário do Porto, Porto, Portugal.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Garrido', 'Affiliation': 'Department of Gastroenterology, Hospital de Santo António, Centro Hospitalar Universitário do Porto, Porto, Portugal.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Santos', 'Affiliation': 'Instituto de Ciências Biomédicas Abel Salazar, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Pedroto', 'Affiliation': 'Department of Gastroenterology, Hospital de Santo António, Centro Hospitalar Universitário do Porto, Porto, Portugal.'}, {'ForeName': 'Fernando M', 'Initials': 'FM', 'LastName': 'Castro-Poças', 'Affiliation': 'Department of Gastroenterology, Hospital de Santo António, Centro Hospitalar Universitário do Porto, Porto, Portugal.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000002117']
293,34843072,Clinical efficacy of digital chest drainage system in cardiac valve surgery.,"OBJECTS


The portable digitalized suction was used widely in thoracic surgery. The aim of the study was to access the early outcomes of using the portable digitalized suction system after cardiac surgery.
METHODS


We invested 80 patients including 30 women (mean age 72.7 ± 9.2 years) who underwent cardiac surgery at our hospital, excluded coronary artery bypass grafting only, with or only aortic surgery, emergency operation, and patients with hemodialysis. Patients were categorized as those treated with digital chest drainage system (DCS group, n = 38) or analog chest drainage system (ACS group, n = 42), and the following data were analyzed in two groups. The primary endpoint was the duration of chest drainage, and the secondary endpoints were the rate of drainage-related complications and the length of hospitalization.
RESULTS


The duration of drainage was significantly shorter in the DCS group (ACS vs. DCS = 94.8 ± 31.5 vs. 81.1 ± 20.6 h, p = 0.036). The duration needed for rehabilitation completion was significantly shorter in the DCS group (ACS vs. DCS = 10.7 ± 1.2 vs. 9.6 ± 1.5 days, p = 0.047), and the length of hospitalization was significantly shorter in the DCS group (ACS vs. DCS = 21.9 ± 5.3 vs. 18.8 ± 7.2 days, p = 0.031).
CONCLUSIONS


This study provided evidence that DCS might be effective for patients who underwent cardiac valve surgery.",2022,"The duration needed for rehabilitation completion was significantly shorter in the DCS group (ACS vs. DCS = 10.7 ± 1.2 vs. 9.6 ± 1.5 days, p = 0.047), and the length of hospitalization was significantly shorter in the DCS group (ACS vs. DCS = 21.9 ± 5.3 vs. 18.8 ± 7.2 days, p = 0.031).
","['patients who underwent cardiac valve surgery', 'cardiac valve surgery', '80 patients including 30 women (mean age 72.7\u2009±\u20099.2\xa0years) who underwent cardiac surgery at our hospital, excluded coronary artery bypass grafting only, with or only aortic surgery, emergency operation, and patients with hemodialysis']","['DCS', 'digital chest drainage system (DCS group, n\u2009=\u200938) or analog chest drainage system (ACS', 'portable digitalized suction system', 'portable digitalized suction', 'digital chest drainage system']","['duration of chest drainage', 'rate of drainage-related complications and the length of hospitalization', 'duration needed for rehabilitation completion', 'length of hospitalization', 'duration of drainage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0877130', 'cui_str': 'Aortic surgery'}, {'cui': 'C0184893', 'cui_str': 'Emergency operation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0554831', 'cui_str': 'Digitalization done'}, {'cui': 'C3873867', 'cui_str': 'Suction system'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",80.0,0.0429528,"The duration needed for rehabilitation completion was significantly shorter in the DCS group (ACS vs. DCS = 10.7 ± 1.2 vs. 9.6 ± 1.5 days, p = 0.047), and the length of hospitalization was significantly shorter in the DCS group (ACS vs. DCS = 21.9 ± 5.3 vs. 18.8 ± 7.2 days, p = 0.031).
","[{'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Cardiovascular Surgery, Soka Municipal Hospital, 2-21-1 Soka, Soka-shi, Saitama, 340-8560, Japan. tamuratsrg@yahoo.co.jp.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Sakurai', 'Affiliation': 'Department of Cardiovascular Surgery, Soka Municipal Hospital, 2-21-1 Soka, Soka-shi, Saitama, 340-8560, Japan.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-021-01752-9']
294,34997685,Estimation of a treatment policy estimand for time to event data using data collected post discontinuation of randomised treatment.,"Discontinuation from randomised treatment is a common intercurrent event in clinical trials. When the target estimand uses a treatment policy strategy to deal with this intercurrent event, data after cessation of treatment is relevant to estimate the estimand and all efforts should be made to collect such data. Missing data may nevertheless occur due to participants withdrawing from the study and assumptions regarding the values for data that are missing are required for estimation. A missing-at-random assumption is commonly made in this setting, but it may not always be viewed as appropriate. Another potential approach is to assume missing values are similar to data collected after treatment discontinuation. This idea has been previously proposed in the context of recurrent event data. Here we extend this approach to time-to-event outcomes using the hazard function. We propose imputation models that allow for different hazard rates before and after treatment discontinuation and use the posttreatment discontinuation hazard to impute events for participants with missing follow-up periods due to study withdrawal. The imputation models are fitted as Andersen-Gill models. We illustrate the proposed methods with an example of a clinical trial in patients with chronic obstructive pulmonary disease.",2022,"When the target estimand uses a treatment policy strategy to deal with this intercurrent event, data after cessation of treatment is relevant to estimate the estimand and all efforts should be made to collect such data.",['patients with chronic obstructive pulmonary disease'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",[],[],,0.201558,"When the target estimand uses a treatment policy strategy to deal with this intercurrent event, data after cessation of treatment is relevant to estimate the estimand and all efforts should be made to collect such data.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hartley', 'Affiliation': 'Veramed Ltd., Twickenham, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Drury', 'Affiliation': 'Department of Biostatistics, GlaxoSmithKline Research and Development, Brentford, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'Department of Biostatistics, GlaxoSmithKline Research and Development, Brentford, UK.'}, {'ForeName': 'Bhabita', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Department of Biostatistics, GlaxoSmithKline Research and Development, Brentford, UK.'}, {'ForeName': 'Oliver N', 'Initials': 'ON', 'LastName': 'Keene', 'Affiliation': 'Department of Biostatistics, GlaxoSmithKline Research and Development, Brentford, UK.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Abellan', 'Affiliation': 'Department of Biostatistics, GlaxoSmithKline Research and Development, Brentford, UK.'}]",Pharmaceutical statistics,['10.1002/pst.2189']
295,34845313,The impact of vitamin K2 and native vitamin D supplementation on vascular calcification in pediatric patients on regular hemodialysis. A randomized controlled trial.,"BACKGROUND AND AIM


Vascular calcification is one of the most prevalent disorders in pediatric hemodialysis patients that eventually lead to cardiovascular morbidity. Vitamin K2 was investigated in adults in previous studies and showed favorable effects on calcification markers. Our aim in this study was to evaluate the efficacy and safety of vitamin K2 and cholecalciferol on the calcification regulators in pediatric patients.
METHODS


A prospective, randomized and controlled trial was conducted on sixty hemodialysis pediatric patients who were divided to four groups; Group 1: administered 100 µg of vitamin K2 (MK-7); Group 2: administered 10 µg of native vitamin D; Group 3: administered 100 µg of vitamin K2 (MK-7) in addition 10 µg of native vitamin D, and Group 4: administered the standard therapy only. The duration of supplementation was 4 months. In addition to a group of healthy normal control of age and sex-matched.
RESULTS


At the end of the study period, serum levels of FGF23, dp-uc-MGP, and uc-OC were measured. It was found that serum levels of dp-uc-MGP, uc-OC, and FGF23 were significantly higher (p < 0.05) in the hemodialysis patients as compared to the healthy normal control. After 4 months, group 3 revealed the most significant decrease in dp-uc-MGP, uc-OC as compared to the other groups. However, there was no change in FGF23.
CONCLUSION


Vitamin K2 and native vitamin D showed a beneficial effect on calcification regulators in pediatric hemodialysis patients.
TRIAL REGISTRATION


clinical trial.gov (NCT04145492).",2022,"After 4 months, group 3 revealed the most significant decrease in dp-uc-MGP, uc-OC as compared to the other groups.","['pediatric hemodialysis patients', 'sixty hemodialysis pediatric patients who were divided to four groups; Group 1: administered 100\u2009µg of', 'healthy normal control of age and sex-matched', 'pediatric patients', 'pediatric patients on regular hemodialysis']","['vitamin K2 and native vitamin D supplementation', 'vitamin K2 and cholecalciferol', 'vitamin K2 (MK-7); Group 2: administered 10\u2009µg of native vitamin D; Group 3: administered 100\u2009µg of vitamin K2 (MK-7) in addition 10\u2009µg of native vitamin D, and Group 4: administered the standard therapy only', 'Vitamin K2 and native vitamin D']","['Vitamin K2', 'serum levels of dp-uc-MGP, uc-OC, and FGF23', 'duration of supplementation', 'serum levels of FGF23, dp-uc-MGP, and uc-OC', 'calcification regulators', 'dp-uc-MGP, uc-OC', 'FGF23']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0065752', 'cui_str': 'matrix Gla protein'}, {'cui': 'C3272931', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]",60.0,0.0899391,"After 4 months, group 3 revealed the most significant decrease in dp-uc-MGP, uc-OC as compared to the other groups.","[{'ForeName': 'Radwa', 'Initials': 'R', 'LastName': 'El Borolossy', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. radwa.abdelkader@pharma.asu.edu.eg.'}, {'ForeName': 'Mohamed Samy', 'Initials': 'MS', 'LastName': 'El-Farsy', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",European journal of clinical nutrition,['10.1038/s41430-021-01050-w']
296,34847589,Fast-velocity Resistance Training Improves Force Development and Mobility in Multiple Sclerosis.,"This study aimed to analyze the benefits of a lower-limb fast-velocity concentric resistance training on rate of force development, mobility, and quality of life in people with Multiple Sclerosis. A randomized controlled trial was conducted in 30 people with Multiple Sclerosis, who were randomly assigned to either an experimental (n=18) or a control (n=12) group. The experimental group carried out 10-weeks of fast-velocity concentric resistance training, while the control group did not perform any intervention. Early and late rate of force development during knee extension in both legs, sit-to-stand and Timed Up and Go tests and quality life questionnaire were evaluated before and after intervention. The training program evoked an increase in early rate of force development in experimental group (0-30; Right leg : 63.9%, p<0.001; ES=-1.4; Left leg : 52.7%, p<0.001; ES=-1.0) compared to control group (showed modest increases). Furthermore, experimental group improved mobility after training (Sit-to-stand: 22.2%, p<0.001; ES=1.0; Timed Up and Go Test: 10.1%, p<0.001; ES=1.1) and increased the perception of quality of life after training, while control showed no changes. The fast-velocity concentric resistance training has the potential to improve early rate of force development and mobility after 10-weeks of training. In addition, the increase in self-perceived quality of life following this training modality demonstrates promising results in the Multiple Sclerosis population.",2022,"Timed Up and Go Test: 10.1%, p<0.001;ES=1.1) and increased the perception of quality of life after training, while control showed no changes.","['people with Multiple Sclerosis', 'Multiple Sclerosis', '30 people with Multiple Sclerosis']","['lower-limb fast-velocity concentric resistance training', 'fast-velocity concentric resistance training, while the control group did not perform any intervention', 'Fast-velocity resistance training']","['perception of quality of life', 'self-perceived quality of life', 'sit-to-stand and Timed Up and Go tests and quality life questionnaire', 'early rate of force development', 'mobility', 'rate of force development, mobility, and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",30.0,0.0114624,"Timed Up and Go Test: 10.1%, p<0.001;ES=1.1) and increased the perception of quality of life after training, while control showed no changes.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Andreu-Caravaca', 'Affiliation': 'International Chair of Sports Medicine, Universidad Católica San Antonio de Murcia, Murcia, Spain.'}, {'ForeName': 'Domingo Jesús', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Department of Education, Universidad de Alcalá de Henares, Alcala de Henares, Spain.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Chung', 'Affiliation': 'UCAM Research Center for High Performance Sport, Universidad Católica San Antonio de Murcia, Murcia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Manonelles', 'Affiliation': 'International Chair of Sports Medicine, Universidad Católica San Antonio de Murcia, Murcia, Spain.'}, {'ForeName': 'Joao Paulo Vilas', 'Initials': 'JPV', 'LastName': 'Boas', 'Affiliation': 'LABIOMEP, University of Porto, Porto, Portugal.'}, {'ForeName': 'Jacobo Ángel', 'Initials': 'JÁ', 'LastName': 'Rubio-Arias', 'Affiliation': 'LABIOMEP, University of Porto, Porto, Portugal.'}]",International journal of sports medicine,['10.1055/a-1710-1492']
297,34846805,"Digital medical history implementation to triage orthopaedic patients during COVID-19: Findings from a rapid cycle, semi-randomised A/B testing quality improvement project.","INTRODUCTION


The COVID-19 pandemic severely impacted musculoskeletal care. To better triage the notable backlog of patients, we assessed whether a digital medical history (DMH), a summary of health information and concerns completed by the patient prior to a clinic visit, could be routinely collected and utilised.
METHODS


We analysed 640 patients using a rapid cycle, semi-randomised A/B testing approach. Four rapid cycles of different randomised interventions were conducted across five unique patient groups. Descriptive statistics were used to report DMH completion rates by cycle/patient group and intervention. Multivariable logistic regression was used to determine whether age or anatomic injury location was associated DMH completion.
ETHICAL APPROVAL


N/A (Quality Improvement Project) RESULTS: Across all patients, the DMH completion rate was 48% (307/640). Phone calls were time consuming and resource intensive without an increased completion rate. The highest rate of DMH completion was among patients who were referred and called the clinic themselves (78% of patients [63 out of 81 patients]). Across all patients, increasing age (odds ratio [OR]: 0.985 (95% CI: 0.976-0.995), p = 0.002), patients with back concerns (OR: 0.395 (95% CI: 0.234-0.666), p = 0.001), and patients with non-specific/other musculoskeletal concerns (OR: 0.331 (95% CI: 0.176-0.623), p = 0.001) were associated with decreased odds of DMH completion.
DISCUSSION AND CONCLUSION


DMHs can be valuable in helping triage orthopaedic patients in resource-strapped settings, times of crisis, or as we transition towards value-based health care delivery. However, further work is needed to continue to increase the completion rate about 50%.",2022,"Across all patients, increasing age (odds ratio [OR]: 0.985 (95% CI: 0.976-0.995), p = 0.002), patients with back concerns (OR: 0.395 (95% CI: 0.234-0.666), p = 0.001), and patients with non-specific/other musculoskeletal concerns (OR: 0.331 (95% CI: 0.176-0.623), p = 0.001) were associated with decreased odds of DMH completion.
","['triage orthopaedic patients during COVID-19', '640 patients using a rapid cycle, semi-randomised A/B testing approach']",['Digital medical history implementation'],"['completion rate', 'highest rate of DMH completion', 'DMH completion rates', 'DMH completion rate']","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0262926', 'cui_str': 'History of'}]",640.0,0.101752,"Across all patients, increasing age (odds ratio [OR]: 0.985 (95% CI: 0.976-0.995), p = 0.002), patients with back concerns (OR: 0.395 (95% CI: 0.234-0.666), p = 0.001), and patients with non-specific/other musculoskeletal concerns (OR: 0.331 (95% CI: 0.176-0.623), p = 0.001) were associated with decreased odds of DMH completion.
","[{'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Bernstein', 'Affiliation': 'Department of Orthopaedic Surgery, Harvard Combined Orthopaedic Residency Program (HCORP), Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Meijers', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Portengen', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Klaassen', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Vanessa A B', 'Initials': 'VAB', 'LastName': 'Scholtes', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Diederik H R', 'Initials': 'DHR', 'LastName': 'Kempen', 'Affiliation': 'Department of Orthopaedic Surgery, Joint Research, OLVG Amsterdam, Amsterdam, The Netherlands.'}]",Musculoskeletal care,['10.1002/msc.1605']
298,34850164,Effect of Electronic Nicotine Delivery Systems on Cigarette Abstinence in Smokers With No Plans to Quit: Exploratory Analysis of a Randomized Placebo-Controlled Trial.,"INTRODUCTION


The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking is unclear. This exploratory analysis examined the effects of ENDS delivering different amounts of nicotine on cigarette abstinence up to 24-week follow-up, in comparison to placebo or a behavioral substitute.
METHODS


This four-arm parallel-group, randomized, placebo-controlled trial took place at two academic medical centers in the United States (Penn State Hershey and Virginia Commonwealth University). Participants were current adult smokers (N = 520) interested in reducing but not planning to quit. They received brief advice and were randomized to one of four 24-week conditions, receiving either an eGo-style ENDS paired with 0, 8, or 36 mg/ml nicotine liquid (double-blind) or a cigarette-shaped tube, as a cigarette substitute (CS). Self-reported daily cigarette consumption and exhaled carbon monoxide (CO) were measured at all study visits. Outcomes included intent-to-treat, self-reported 7-day cigarette abstinence, biochemically confirmed by exhaled CO at 24 weeks after randomization.
RESULTS


At 24 weeks, significantly more participants in the 36 mg/ml condition (14/130, 10.8%) than in the 0 mg/ml condition (1/130, 0.8%) and the CS condition (4/130, 3.1%) were abstinent (relative risk = 14 [95% CI = 1.9-104.9] and 3.5 [95% CI = 1.2-10.4], respectively). The abstinence rate in the 8 mg/ml condition was 4.6% (6/130).
CONCLUSIONS


When smokers seeking to reduce smoking tried ENDS, few quit smoking in the short term. However, if smokers continued to use an ENDS with cigarette-like nicotine delivery, a greater proportion completely switched to ENDS, as compared with placebo or a cigarette substitute.
IMPLICATIONS


The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking was unclear. This randomized trial found that ENDS with nicotine delivery approaching that of a cigarette are more effective in helping ambivalent smokers to quit cigarette smoking.",2022,"At 24 weeks, significantly more participants in the 36 mg/ml condition (14/130, 10.8%) than in the 0 mg/ml condition (1/130, 0.8%) and the CS condition (4/130, 3.1%) were abstinent (relative risk = 14 [95% CI=1.9-104.9] and 3.5 [95% CI=1.2-10.4], respectively).","['Participants were current adult smokers (N=520) interested in reducing but not planning to quit', 'smokers with no plans to quit smoking', 'controlled trial took place at two academic medical centers in USA (Penn State Hershey and Virginia Commonwealth University', 'Smokers with no Plans to Quit']","['Electronic Nicotine Delivery Systems', 'Placebo', 'ENDS', 'electronic nicotine delivery systems (ENDS', 'placebo', 'eGo-style ENDS paired with 0, 8 or 36\xa0mg/ml nicotine liquid (double-blind) or a cigarette-shaped tube, as a cigarette substitute (CS', 'ENDS with nicotine', 'nicotine']","['abstinence rate', 'cigarette abstinence', 'intent-to-treat, self-reported 7-day cigarette abstinence', 'Cigarette Abstinence', 'Self-reported daily cigarette consumption and exhaled carbon monoxide (CO', 'CS condition']","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.400211,"At 24 weeks, significantly more participants in the 36 mg/ml condition (14/130, 10.8%) than in the 0 mg/ml condition (1/130, 0.8%) and the CS condition (4/130, 3.1%) were abstinent (relative risk = 14 [95% CI=1.9-104.9] and 3.5 [95% CI=1.2-10.4], respectively).","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Cobb', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Miao-Shan', 'Initials': 'MS', 'LastName': 'Yen', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Veldheer', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Brosnan', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Yingst', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Hrabovsky', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Alexa A', 'Initials': 'AA', 'LastName': 'Lopez', 'Affiliation': 'College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Sophia I', 'Initials': 'SI', 'LastName': 'Allen', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Sciamanna', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hammett', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Breianna L', 'Initials': 'BL', 'LastName': 'Hummer', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Lester', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Richie', 'Affiliation': 'Center for Research on Tobacco & Health, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Chowdhury', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Graham', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Shumei', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab247']
299,34851810,Effectiveness of a group intervention to reduce sexual transmission risk behavior among MSM living with HIV: a non-randomized controlled pilot study.,"ABSTRACT With an annual incidence of about 1.5 million new infections, HIV is an ongoing public health concern. Sexual transmission risk behavior (STRB) is a main driver of the HIV epidemic in most Western countries, particularly among specific populations such as men who have sex with men (MSM). This quasi-experimental pilot study examined the effectiveness of a ten-session group intervention, aiming to reduce STRB among a high-risk subpopulation of MSM living with HIV. Self-reported STRB, impulsivity, mental health symptoms, and functional impairment were compared between the intervention group ( n  = 12) and a control group ( n  = 16). At baseline, participants in the intervention group had higher levels of STRB, impulsivity, mental health problems, and functional impairment, compared to the control group. A significant time-by-group interaction effect revealed that after the intervention, STRB, impulsivity, and functional impairment reduced in the intervention group to levels comparable to the control group. These findings suggest that a targeted behavioral intervention might be an effective strategy to reduce persistent STRB and related factors in MSM living with HIV. Future studies should confirm these findings in larger samples, using randomized designs.",2022,"At baseline, participants in the intervention group had higher levels of STRB, impulsivity, mental health problems, and functional impairment, compared to the control group.",['men who have sex with men (MSM'],"['Sexual transmission risk behavior (STRB', 'MSM living with HIV']","['sexual transmission risk behavior', 'STRB, impulsivity, and functional impairment', 'higher levels of STRB, impulsivity, mental health problems, and functional impairment', 'Self-reported STRB, impulsivity, mental health symptoms, and functional impairment']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C1519279', 'cui_str': 'Sexual transmission'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1519279', 'cui_str': 'Sexual transmission'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.018554,"At baseline, participants in the intervention group had higher levels of STRB, impulsivity, mental health problems, and functional impairment, compared to the control group.","[{'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Arends', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Karin J T', 'Initials': 'KJT', 'LastName': 'Grintjes', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Thom J', 'Initials': 'TJ', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Eline G J', 'Initials': 'EGJ', 'LastName': 'Foeken-Verwoert', 'Affiliation': 'Youz, Arnhem, Netherlands.'}, {'ForeName': 'Aart H', 'Initials': 'AH', 'LastName': 'Schene', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Andre J A M', 'Initials': 'AJAM', 'LastName': 'van der Ven', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Arnt F A', 'Initials': 'AFA', 'LastName': 'Schellekens', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}]",AIDS care,['10.1080/09540121.2021.2002252']
300,34861227,"Standardized, Coordinated Care in Nursing Homes Lowers Rehospitalization After Hip Fracture.","OBJECTIVES


To assess the effect of enhanced standardized interdisciplinary cooperation between the orthogeriatric ward, municipality, and nursing home facility (NHF) on readmission rates in patients with hip fracture.
DESIGN


Quasi-experimental design with a nonequivalent control group.
SETTING AND PARTICIPANTS


From January 2018 to July 2020, patients with hip fracture who were admitted to the department of orthopedic surgery and traumatology at Lillebaelt Hospital, and later discharged to NHF were included.
INTERVENTION


The intervention consisted of a safety program to the NHF for the first 14 days postdischarge and included assessment of vital signs, weight, pain, signs of constipation, hours of mobilization, and daily intake of fluids and high-protein beverages. Acute team nurses undertook visits (planned and unplanned) and could take blood samples and administer intravenous fluids or antibiotics at the NHF. Control participants received usual care.
METHODS


The intervention was performed in 2 municipalities with an acute team; the remaining 3 municipalities comprised the control group. The primary outcome was 30-day readmission, and secondary outcomes were mortality, mobility, and quality of life.
RESULTS


There were 100 patients in the intervention group and 152 in the control group. The median age was 86 years, 68% were female, and more than 60% had a low mental score; there were no statistical differences between groups in baseline variables. The 30-day readmission rate was 14% in the intervention group and 30% in the control group (P = .004). The 30-day mortality rate was 6% in the intervention group and 13% in the control group (P = .07). There was no statistically significant difference in mobility between the 2 groups but there was a higher health-related quality of life score in the intervention group (P = .045).
CONCLUSIONS AND IMPLICATIONS


Enhanced standardized interdisciplinary cooperation between hospital, NHF teams, and visiting acute team nurses can lower readmissions and potentially mortality.",2022,"There was no statistically significant difference in mobility between the 2 groups but there was a higher health-related quality of life score in the intervention group (P = .045).
","['100 patients in the intervention group and 152 in the control group', 'patients with hip fracture', 'From January 2018 to July 2020, patients with hip fracture who were admitted to the department of orthopedic surgery and traumatology at Lillebaelt Hospital, and later discharged to NHF were included']",['usual care'],"['Rehospitalization', '30-day readmission rate', '30-day readmission', '30-day mortality rate', 'higher health-related quality of life score', 'mobility', 'mortality, mobility, and quality of life', 'readmission rates']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0040801', 'cui_str': 'Surgical Traumatology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0584536', 'cui_str': 'Discharge to nursing home'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",2.0,0.022538,"There was no statistically significant difference in mobility between the 2 groups but there was a higher health-related quality of life score in the intervention group (P = .045).
","[{'ForeName': 'Bjarke', 'Initials': 'B', 'LastName': 'Viberg', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark; Department of Regional Research, University of Southern Denmark, Odense, Denmark. Electronic address: bjarke.viberg@rsyd.dk.'}, {'ForeName': 'Lars Uldum', 'Initials': 'LU', 'LastName': 'Erlandsen Claville', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Lis R', 'Initials': 'LR', 'LastName': 'Andersen', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Fredholm', 'Affiliation': 'Department of Geriatrics, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Dall-Hansen', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Grejsen', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.11.003']
301,34902548,"Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain.","Prior work established post-treatment efficacy for an 8-week home-based therapeutic virtual reality (VR) program in a double-blind, parallel arm, randomized placebo-controlled study. Participants were randomized 1:1 to 1 of 2 56-day VR programs: 1) a therapeutic immersive pain relief skills VR program; or 2) a Sham VR program within an identical commercial VR headset. Immediate post-treatment results demonstrated clinically meaningful and superior reduction for therapeutic VR compared to Sham VR for average pain intensity, indices of pain-related interference (activity, mood, stress but not sleep), physical function, and sleep disturbance. The objective of the current report was to quantify treatment effects to post-treatment month 3 and describe durability of effects. Intention-to-treat analyses revealed sustained benefits for both groups and superiority for therapeutic VR for pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes ranged from d rm  = .56-.88) and physical function from pre-treatment to post-treatment month 3. The between-group difference for sleep disturbance was non-significant and pain-interference with mood did not survive multiplicity correction at 3 months. For most primary and secondary outcomes, treatment effects for therapeutic VR showed durability, and maintained superiority to Sham VR in the 3-month post-treatment period. PERSPECTIVE: We present 3-month follow-up results for 8-week self-administered therapeutic virtual reality (VR) compared to Sham VR in adults with chronic low back pain. Across multiple pain indices, therapeutic VR had clinically meaningful benefits, and superiority over Sham VR. Home-based, behavioral skills VR yielded enduring analgesic benefits; longer follow-up is needed.",2022,"Intention-to-treat analyses revealed sustained benefits for both groups and superiority for therapeutic VR for pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes ranged from d rm  = .56-.88) and physical function from pre-treatment to post-treatment month 3.","['adults with chronic low back pain', 'Chronic Low Back Pain']","['placebo', 'Sham VR', 'Placebo', '8-week home-based therapeutic virtual reality (VR) program', '8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR', 'therapeutic immersive pain relief skills VR program; or 2) a Sham VR program within an identical commercial VR headset', '8-week self-administered therapeutic virtual reality (VR']","['physical function', 'average pain intensity, indices of pain-related interference (activity, mood, stress but not sleep), physical function, and sleep disturbance', 'sleep disturbance', 'pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes', 'durability, and maintained superiority to Sham VR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",,0.128097,"Intention-to-treat analyses revealed sustained benefits for both groups and superiority for therapeutic VR for pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes ranged from d rm  = .56-.88) and physical function from pre-treatment to post-treatment month 3.","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Garcia', 'Affiliation': 'AppliedVR, Inc, University of Southern California, Creative Media and Behavioral Health Center, Los Angeles, California.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Birckhead', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Parthasarathy', 'Initials': 'P', 'LastName': 'Krishnamurthy', 'Affiliation': 'University of Houston, C.T. Bauer College of Business, Houston, Texas.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Mackey', 'Affiliation': 'AppliedVR, Inc, Van Nuys, California.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Sackman', 'Affiliation': 'AppliedVR, Inc, Van Nuys, California.'}, {'ForeName': 'Vafi', 'Initials': 'V', 'LastName': 'Salmasi', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Louis', 'Affiliation': 'Division of Neurosurgery, Pickup Family Neurosciences Institute, Hoag Memorial Hospital Newport Beach, CA, United States, Newport Beach, California.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Maddox', 'Affiliation': 'AppliedVR, Inc, Van Nuys, California.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California. Electronic address: bdarnall@stanford.edu.'}]",The journal of pain,['10.1016/j.jpain.2021.12.002']
302,34871469,"Alliance rupture profiles by personality disorder pathology in psychotherapy for depression: Tendencies, development, and timing.","OBJECTIVE


Clinical and theoretical considerations presume that patients with different personality disorder (PD) clusters will be associated with distinct alliance rupture profiles; however, there is scarce empirical literature examining this. The present study adopted a systematic framework for investigating profiles of alliance ruptures for individuals belonging to each of the three PD clusters.
METHOD


The sample consisted of 94 patients from a randomized controlled trial for treatment of depression. PD cluster features were assessed at intake and ruptures were assessed across treatment. Three sets of multilevel analyses were conducted to test differences between the PD clusters in the general tendency to show a rupture profile, rupture development throughout the treatment, and timing of predicting ruptures by PD within sessions.
RESULTS


The three clusters were associated with distinct profiles of alliance ruptures. Clusters A and B were characterized by a general tendency to show more withdrawal and confrontation ruptures. Cluster A had a greater decrease in confrontation ruptures over the course of treatment, while cluster B had a greater decrease in withdrawal ruptures. Cluster C was characterized by a general tendency to show fewer withdrawal and confrontation ruptures, with a greater increase in both ruptures over the course of treatment. For withdrawal ruptures, the differences between clusters were evident from the beginning of sessions, whereas for confrontation ruptures, there was less of a difference between beginning and end of sessions.
CONCLUSION


The distinct profiles of alliance ruptures for each PD cluster may contribute to progress towards tailoring treatment to individuals with PDs.",2022,"For withdrawal ruptures, the differences between clusters were evident from the beginning of sessions, whereas for confrontation ruptures, there was less of a difference between beginning and end of sessions.
","['patients with different personality disorder (PD) clusters', 'individuals with PDs', 'individuals belonging to each of the three PD clusters']",[],"['confrontation ruptures', 'withdrawal ruptures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C0009084', 'cui_str': 'Cluster A personality disorder'}]",[],"[{'cui': 'C1444674', 'cui_str': 'Confrontation visual field test'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",94.0,0.0812602,"For withdrawal ruptures, the differences between clusters were evident from the beginning of sessions, whereas for confrontation ruptures, there was less of a difference between beginning and end of sessions.
","[{'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Lipsitz-Odess', 'Affiliation': 'The Department of Psychology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Benisty', 'Affiliation': 'The Department of Neuroscience, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Tohar', 'Initials': 'T', 'LastName': 'Dolev-Amit', 'Affiliation': 'The Department of Psychology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'The Department of Psychology, University of Haifa, Haifa, Israel.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2700']
303,34895978,"Comment on: ""Ultrasound-guided erector spinae plane block for postoperative analgesia in patients undergoing open radical prostatectomy: A randomized, placebo-controlled trial"".",,2022,,['patients undergoing open radical prostatectomy'],"['placebo', 'Ultrasound-guided erector spinae plane block']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",[],,0.439357,,"[{'ForeName': 'Fu-Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China. Electronic address: xuefushan@aliyun.com.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Tian', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110629']
304,34895920,Intramedullary nail versus bridge plate in open tibial fractures - randomized clinical trial.,,2022,,[],['Intramedullary nail versus bridge plate'],[],[],"[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]",[],,0.17605,,"[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopaedics, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu, 215300, China. Electronic address: sgu8434@sina.com.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu, 215300, China. Electronic address: lichong1705@163.com.'}, {'ForeName': 'Yi-Jun', 'Initials': 'YJ', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopaedics, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu, 215300, China. Electronic address: gaoyijun2010@163.com.'}]",Injury,['10.1016/j.injury.2021.11.058']
305,34895792,The use of propranolol in adult burn patients: Safety and outcome influence.,"OBJECTIVES


This study investigated safety and effect of propranolol on adult patients with severe burn.
METHODS


A prospective study was conducted on 124 severely adult burn patients who were randomly divided into propranolol and non-propranolol group. Propranolol was given by nasogastric tube to achieve the target of lowering 15-20% of initial heart rate.
RESULTS


Average dose of propranolol was 1.9 ± 0.5 mg/kg/day ranging from 0.9 to 3.3 mg/kg/day and was not affected by burn extent and inhalation injury. Mean heart rate reduced by 21.2% during the 28 day period. Recorded adverse events included hypotension (11.9%), bradycardia (1.6%), hypoglycemia (17.7%) and total number of held events was 8 occurring in 7 (11.3%) patients. Serum levels of glucose, total protein, albumin, cholesterol and triglyceride at different times were not significantly different between the two groups. Significantly lower resting energy expenditure on the 7 th  and 14 th  day were seen in propranolol group (p < 0.05). After 3 weeks, liver size in the propranolol group did not change significantly from admission, while in the non-propranolol group, liver size increased significantly (p < 0.05). The complete healing time of partial-thickness burns and donor sites were significantly shorter in propranolol group (p < 0.01). Duration of ventilation, length of stay in intensive care unit and in hospital, number of operations, rate of multiple organ failure, and death were not different between the two groups (p > 0.05).
CONCLUSION


For severely burned adults, propranolol was safe and effective on reducing energy expenditure, limited hepatomegaly, and accelerated partial burn wound and donor site closure, but does not affect length of stay in ICU, hospitalization, complication ormortality rate.",2022,"Serum levels of glucose, total protein, albumin, cholesterol and triglyceride at different times were not significantly different between the two groups.","['severely burned adults', 'adult patients with severe burn', 'group', 'adult burn patients', '124 severely adult burn patients who were randomly divided into']","['propranolol and non-propranolol', 'Propranolol', 'propranolol']","['hypoglycemia', 'Duration of ventilation, length of stay in intensive care unit and in hospital, number of operations, rate of multiple organ failure, and death', 'Mean heart rate', 'total number of held events', 'energy expenditure, limited hepatomegaly, and accelerated partial burn wound and donor site closure', 'complete healing time of partial-thickness burns and donor sites', 'liver size', 'resting energy expenditure', 'bradycardia', 'Serum levels of glucose, total protein, albumin, cholesterol and triglyceride at different times', 'length of stay in ICU, hospitalization, complication ormortality rate', 'hypotension']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0019209', 'cui_str': 'Large liver'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332687', 'cui_str': 'Second degree burn injury'}, {'cui': 'C0426688', 'cui_str': 'Liver size'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",124.0,0.0125253,"Serum levels of glucose, total protein, albumin, cholesterol and triglyceride at different times were not significantly different between the two groups.","[{'ForeName': 'Nguyen Nhu', 'Initials': 'NN', 'LastName': 'Lam', 'Affiliation': 'National Burn Hospital, Hanoi, Viet Nam; Medical Military University, Viet Nam. Electronic address: lamnguyenau@yahoo.com.'}, {'ForeName': 'Phan Quoc', 'Initials': 'PQ', 'LastName': 'Khanh', 'Affiliation': 'Region 4 Military Hospital, Viet Nam.'}, {'ForeName': 'Nguyen Hai', 'Initials': 'NH', 'LastName': 'An', 'Affiliation': 'National Burn Hospital, Hanoi, Viet Nam; Medical Military University, Viet Nam.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2021.08.024']
306,34903403,The effect of training program based on health belief model on burn prevention knowledge in mothers of children aged to 1-3 years: A randomized controlled.,"PURPOSE


One of the effective models in health education is the health belief model that considers a person's behavior as a under the influence of knowledge and attitude. In the present study, we investigated the efficacy of a training program based on the health belief model in burn prevention knowledge in mothers of children aged between 1 and 3 years old.
DESIGN AND METHODS


This single blind randomized Control Trial study was conducted on 64 mothers with a child aged between 12 and 36 months who were referred to the Health Centers of Shiraz, Iran, in 2018. Accordingly, using cluster sampling, 4 health centers were selected and then 2 centers were assigned to the intervention group and 2 other centers to the control group by randomization. The intervention group received six sessions of training. However, in order to observe the ethical principles, the educational content was provided to the control group at the end of the present study. Both groups completed health belief model questionnaire before, after the intervention, and by passing 2 months from the intervention. The collected data were compared between the two groups using SPSS software, version 25.
RESULTS


We found no differences in the demographics of the two study groups (P > 0.05). Intragroup comparison in the intervention and control groups indicated a significant difference among the three intervals (both P = 0.001). As well, a difference was found between the intervention and the control groups immediately after the intervention and 2 months after the intervention (both P < 0.001). Additionally, in both groups, the relationship between mothers' knowledge score and each dimension of the health belief model was examined, which was a significant. (P = 0.001).
CONCLUSION


Health belief model can be considered as an effective method for educating mothers in terms of the prevention of children's burn and the increased the mothers' knowledge.
PRACTICE IMPLICATIONS


The health belief model was shown to have a good effect on educating mothers regarding child burn's prevention. So, due to this reason, it is recommended to use this model for burn's prevention training programs.",2022,Intragroup comparison in the intervention and control groups indicated a significant difference among the three intervals (both P = 0.001).,"['64 mothers with a child aged between 12 and 36 months who were referred to the Health Centers of Shiraz, Iran, in 2018', 'mothers of children aged between 1 and 3 years old', 'mothers of children aged to 1-3 years']",['training program'],[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],64.0,0.00239606,Intragroup comparison in the intervention and control groups indicated a significant difference among the three intervals (both P = 0.001).,"[{'ForeName': 'Iran', 'Initials': 'I', 'LastName': 'Tajiki', 'Affiliation': 'Community health Nursing, Student Research Committee, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran; Community Based Psychiatric Care Research Center, Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Vizeshfar', 'Affiliation': 'Community health Nursing, Student Research Committee, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran; Community Based Psychiatric Care Research Center, Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: vizeshfarf@sums.ac.ir.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Keshtkaran', 'Affiliation': 'Community health Nursing, Student Research Committee, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran; Community Based Psychiatric Care Research Center, Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2021.11.001']
307,34893775,Avelumab maintenance in advanced urothelial carcinoma: biomarker analysis of the phase 3 JAVELIN Bladder 100 trial.,"In a recent phase 3 randomized trial of 700 patients with advanced urothelial cancer (JAVELIN Bladder 100; NCT02603432 ), avelumab/best supportive care (BSC) significantly prolonged overall survival relative to BSC alone as maintenance therapy after first-line chemotherapy. Exploratory biomarker analyses were performed to identify biological pathways that might affect survival benefit. Tumor molecular profiling by immunohistochemistry, whole-exome sequencing and whole-transcriptome sequencing revealed that avelumab survival benefit was positively associated with PD-L1 expression by tumor cells, tumor mutational burden, APOBEC mutation signatures, expression of genes underlying innate and adaptive immune activity and the number of alleles encoding high-affinity variants of activating Fcγ receptors. Pathways connected to tissue growth and angiogenesis might have been associated with reduced survival benefit. Individual biomarkers did not comprehensively identify patients who could benefit from therapy; however, multi-parameter models incorporating genomic alteration, immune responses and tumor growth showed promising predictive utility. These results characterize the complex biologic pathways underlying survival benefit from immune checkpoint inhibition in advanced urothelial cancer and suggest that multiple biomarkers might be needed to identify patients who would benefit from treatment.",2021,"Individual biomarkers did not comprehensively identify patients who could benefit from therapy; however, multi-parameter models incorporating genomic alteration, immune responses and tumor growth showed promising predictive utility.","['700 patients with advanced urothelial cancer', 'advanced urothelial cancer', 'advanced urothelial carcinoma']","['BSC alone as maintenance therapy after first-line chemotherapy', 'Avelumab maintenance', 'avelumab/best supportive care (BSC']",['overall survival relative'],"[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",700.0,0.0802487,"Individual biomarkers did not comprehensively identify patients who could benefit from therapy; however, multi-parameter models incorporating genomic alteration, immune responses and tumor growth showed promising predictive utility.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': ""Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London, UK. thomas.powles1@nhs.net.""}, {'ForeName': 'Srikala S', 'Initials': 'SS', 'LastName': 'Sridhar', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': 'Gustave Roussy, INSERMU981, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Department of Medical Oncology, Beth Israel Deaconess Medical Center and IMIM-PSMAR Lab, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Xinmeng Jasmine', 'Initials': 'XJ', 'LastName': 'Mu', 'Affiliation': 'Computational Biology, Oncology Research and Development, Pfizer, La Jolla, CA, USA.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Ching', 'Affiliation': 'Computational Biology, Oncology Research and Development, Pfizer, La Jolla, CA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': 'Statistics, Global Biometrics and Data Management, Pfizer, La Jolla, CA, USA.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, Hematology/Oncology, Meyer Cancer Center, New York, NY, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale Cancer Center, New Haven, CT, USA.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Tambaro', 'Affiliation': 'Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale, Naples, Italy.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Dourthe', 'Affiliation': ""Service d'Oncologie Médicale, Clinique St Anne, Strasbourg, France.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alvarez-Fernandez', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Central de Asturias. Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Spain.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Aarts', 'Affiliation': 'Department of Medical Oncology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, Netherlands.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': 'Pfizer Italia srl, Milano, Italy.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Grivas', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, University of Washington; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, WA, USA.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Davis', 'Affiliation': 'Translational Oncology, Pfizer, La Jolla, CA, USA. craig.davis@pfizer.com.'}]",Nature medicine,['10.1038/s41591-021-01579-0']
308,34910624,Sleep Well!  An adapted behavioral sleep intervention implemented in urban primary care.,"STUDY OBJECTIVES


To describe the adaptation, feasibility, and initial outcomes of  Sleep Well! , an intervention for early childhood insomnia and insufficient sleep, designed for families from lower-socioeconomic status backgrounds presenting to large metropolitan primary care sites.
METHODS


Fifteen caregiver-child dyads (caregivers: 92.3% mothers, 80.0% Black, 53.3% ≤ 125% US poverty level; children: 73.3% female, 86.7% Black, mean age = 3.0 years) participated in this multimethod, single-arm trial. A family advisory board of caregivers (n = 4) and a clinician advisory board of sleep experts, primary care clinicians, and psychologists (n = 13) provided intervention feedback throughout the pilot. Most adaptations were related to intervention delivery methods, with some related to sleep strategies. At postintervention, caregivers completed surveys on intervention acceptability and cultural humility (primary outcomes) and completed semistructured interviews. Caregivers also reported on child sleep pre- and postintervention.
RESULTS


Thirteen (86.6%) families completed  Sleep Well!  and 12 (80.0%) completed pre- and postintervention measures. Caregivers reported strong intervention acceptability and cultural humility. There were preintervention to postintervention reductions in child sleep problems, bedroom electronics, sleep onset latency, and night awakening frequency and duration. Nighttime sleep duration and overall insufficient sleep also improved. Qualitative data also showed strong intervention acceptability and perceived flexibility, with few participation barriers.
CONCLUSIONS


A brief, early childhood behavioral sleep intervention delivered in primary care with families from primarily lower-socioeconomic status backgrounds and/or racially minoritized backgrounds is feasible to implement, with strong retention rates, acceptability, and perceptions of cultural humility. Child sleep improvements are positive and warrant replication in a randomized controlled trial.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Implementing Behavioral Sleep Intervention in Urban Primary Care; URL: https://clinicaltrials.gov/ct2/show/NCT04046341; Identifier: NCT04046341.
CITATION


Williamson AA, Okoroji C, Cicalese O, et al.  Sleep Well!  An adapted behavioral sleep intervention implemented in urban primary care.  J Clin Sleep Med.  2022;18(4):1153-1166.",2022,"There were pre-to-post reductions in child sleep problems, bedroom electronics, sleep onset latency, and night awakening frequency and duration.","['Fifteen caregiver-child dyads ', 'Thirteen (86.6%) families completed  Sleep', 'urban primary care', 'caregivers: 92.3% mothers; 80.0% Black; 53.3% ≤125% US poverty level; children: 73.3% female; 86.7% Black;  M  age = 3.0 years) participated this multi-method, single-arm trial']","['childhood behavioral sleep intervention', 'Sleep', 'behavioral sleep intervention']","['child sleep problems, bedroom electronics, sleep onset latency, and night awakening frequency and duration', 'Sleep', 'Nighttime sleep duration and overall insufficient sleep']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0557652', 'cui_str': 'Bedroom'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]",15.0,0.064026,"There were pre-to-post reductions in child sleep problems, bedroom electronics, sleep onset latency, and night awakening frequency and duration.","[{'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Williamson', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Chimereodo', 'Initials': 'C', 'LastName': 'Okoroji', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Cicalese', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Brittney C', 'Initials': 'BC', 'LastName': 'Evans', 'Affiliation': 'Chicago Psychotherapy, LLC, Chicago, Illinois.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Ayala', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Harvey', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Honore', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kratchman', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Power', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Mindell', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9822']
309,34914037,Correlation of Cerebral and Subcutaneous Glycerol in Severe Traumatic Brain Injury and Association with Tissue Damage.,"BACKGROUND


This study is a substudy of a prospective consecutive double-blinded randomized study on the effect of prostacyclin in severe traumatic brain injury (sTBI). The aims of the present study were to investigate whether there was a correlation between brain and subcutaneous glycerol levels and whether the ratio of interstitial glycerol in the brain and subcutaneous tissue (glycerol brain/sc ) was associated with tissue damage in the brain, measured by using the Rotterdam score, S-100B, neuron-specific enolase (NSE), the Injury Severity Score (ISS), the Acute Physiology and Chronic Health Evaluation Score (APACHE II), and trauma type. A potential association with clinical outcome was explored.
METHODS


Patients with sTBI aged 15-70 years presenting with a Glasgow Coma Scale Score ≤ 8 were included. Brain and subcutaneous adipose tissue glycerol levels were measured through microdialysis in 48 patients, of whom 42 had complete data for analysis. Brain tissue damage was also evaluated by using the Rotterdam classification of brain computed tomography scans and the biochemical biomarkers S-100B and NSE.
RESULTS


In 60% of the patients, a positive relationship in glycerol brain/sc  was observed. Patients with a positive correlation of glycerol brain/sc  had slightly higher brain glycerol levels compared with the group with a negative correlation. There was no significant association between the computed tomography Rotterdam score and glycerol brain/sc . S-100B and NSE were associated with the profile of glycerol brain/sc . Our results cannot be explained by the general severity of the trauma as measured by using the Injury Severity Score or Acute Physiology and Chronic Health Evaluation Score.
CONCLUSIONS


We have shown that peripheral glycerol may flux into the brain. This effect is associated with worse brain tissue damage. This flux complicates the interpretation of brain interstitial glycerol levels. We remind the clinicians that a damaged blood-brain barrier, as seen in sTBI, may alter the concentrations of various substances, including glycerol in the brain. Awareness of this is important in the interpretation of the data bedside as well in research.",2022,There was no significant association between the computed tomography Rotterdam score and glycerol brain/sc .,"['48 patients, of whom 42 had complete data for analysis', 'Patients with sTBI aged 15-70\xa0years presenting with a Glasgow Coma Scale Score\u2009≤\u20098 were included', 'severe traumatic brain injury (sTBI']",['prostacyclin'],"['Brain tissue damage', 'Brain and subcutaneous adipose tissue glycerol levels', 'brain glycerol levels', 'Injury Severity Score or Acute Physiology and Chronic Health Evaluation Score', 'Rotterdam score, S-100B, neuron-specific enolase (NSE), the Injury Severity Score\xa0(ISS), the Acute Physiology and Chronic Health Evaluation Score (APACHE II), and trauma type', 'brain and subcutaneous glycerol levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0033567', 'cui_str': 'Epoprostenol'}]","[{'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]",,0.0986972,There was no significant association between the computed tomography Rotterdam score and glycerol brain/sc .,"[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hägglund', 'Affiliation': 'Department of Clinical Science, Neurosciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Olivecrona', 'Affiliation': 'Department of Anesthesia and Intensive Care, Section of Neurosurgery, Örebro University Hospital and Department for Medical Sciences, Faculty of Health and Medicine, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Lars-Owe D', 'Initials': 'LD', 'LastName': 'Koskinen', 'Affiliation': 'Department of Clinical Science, Neurosciences, Umeå University, Umeå, Sweden. Lars-Owe.Koskinen@umu.se.'}]",Neurocritical care,['10.1007/s12028-021-01412-z']
310,34924557,Compliance with telephone-based lifestyle weight loss programs improves low back pain but not knee pain outcomes: complier average causal effects analyses of 2 randomised trials.,"ABSTRACT


We conducted a complier average causal effect (CACE) analyses for 2 pragmatic randomised controlled trials. We aimed to assess the effectiveness of telephone-based lifestyle weight loss interventions compared with usual care among compliers. Participants from 2 trials with low back pain (n = 160) and knee osteoarthritis (n = 120) with a body mass index ≥27 kg/m2 were included. We defined adherence to the telephone-based lifestyle weight loss program as completing 60% (6 from 10) of telephone health coaching calls. The primary outcomes for CACE analyses were pain intensity (0-10 Numerical Rating Scale) and disability (Roland Morris Disability Questionnaire for low back pain and Western Ontario and McMaster Universities Osteoarthritis Index for knee osteoarthritis). Secondary outcomes were weight, physical activity, and diet. We used an instrumental variable approach to estimate CACE in compliers. From the intervention groups of the trials, 29% of those with low back pain (n = 23/80) and 34% of those with knee osteoarthritis (n = 20/60) complied. Complier average causal effect estimates showed potentially clinically meaningful effects, but with low certainty because of wide confidence intervals, for pain intensity (-1.4; 95% confidence interval, -3.1, 0.4) and small but also uncertain effects for disability (-2.1; 95% confidence interval, -8.6, 4.5) among compliers in the low back pain trial intervention compared with control but not in the knee osteoarthritis trial. Our findings showed that compliers of a telephone-based weight loss intervention in the low back pain trial generally had improved outcomes; however, there were inconsistent effects in compliers from the knee osteoarthritis trial. Complier average causal effect estimates were larger than intention-to-treat results but must be considered with caution.",2022,"Complier average causal effect estimates showed potentially clinically meaningful effects, but with low certainty because of wide confidence intervals, for pain intensity (-1.4; 95% confidence interval, -3.1, 0.4) and small but also uncertain effects for disability (-2.1; 95% confidence interval, -8.6, 4.5) among compliers in the low back pain trial intervention compared with control but not in the knee osteoarthritis trial.",['Participants from 2 trials with low back pain (n = 160) and knee osteoarthritis (n = 120) with a body mass index ≥27 kg/m2 were included'],"['telephone-based lifestyle weight loss program', 'telephone-based weight loss intervention', 'telephone health coaching calls', 'telephone-based lifestyle weight loss programs', 'telephone-based lifestyle weight loss interventions']","['pain intensity (0-10 Numerical Rating Scale) and disability (Roland Morris Disability Questionnaire for low back pain and Western Ontario and McMaster Universities Osteoarthritis Index for knee osteoarthritis', 'weight, physical activity, and diet', 'pain intensity', 'low back pain']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",160.0,0.0961596,"Complier average causal effect estimates showed potentially clinically meaningful effects, but with low certainty because of wide confidence intervals, for pain intensity (-1.4; 95% confidence interval, -3.1, 0.4) and small but also uncertain effects for disability (-2.1; 95% confidence interval, -8.6, 4.5) among compliers in the low back pain trial intervention compared with control but not in the knee osteoarthritis trial.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Robson', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Kamper', 'Affiliation': 'School of Health Sciences, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Hopin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine and Rehabilitation Research in Oxford, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Kerrin', 'Initials': 'K', 'LastName': 'Palazzi', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': ""O'Brien"", 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Hodder', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}]",Pain,['10.1097/j.pain.0000000000002506']
311,34915980,"Dose-response relationship between weight loss and improvements in obstructive sleep apnea severity after a diet/lifestyle interventions: secondary analyses of the ""MIMOSA"" randomized clinical trial.","STUDY OBJECTIVES


Lifestyle-induced weight loss is a complementary therapeutic approach for obstructive sleep apnea (OSA). We aimed at identifying the dose-response relationship between weight loss and OSA severity improvement.
METHODS


This is a secondary analysis of a 6-month clinical trial in 180 adult, overweight/obese moderate-to-severe OSA patients. Participants were randomized to a standard care, a Mediterranean diet, or a Mediterranean lifestyle arm. All patients were prescribed with continuous positive airway pressure (CPAP), while intervention arms additionally participated in a weight-loss dietary/lifestyle intervention. Based on percent change in weight at 6 months, participants were categorized into a weight-stable/gain (WS/GG) group or 3 weight-loss groups (WLG): < 5%WLG, 5%-10%WLG, and ≥ 10%WLG. Polysomnographic data and OSA symptoms were evaluated preintervention and postintervention.
RESULTS


Respiratory events and oximetry indices improved only in patients who lost weight and improvements were proportional to the degree of weight loss. Median percent change in apnea-hypopnea index (AHI) was -11.7%, - 37.9%, and - 49.3% in the < 5%WLG, 5%-10%WLG, and ≥ 10%WLG, respectively ( P  < .001). Compared to the WS/GG, the age-, sex-, baseline-, and CPAP use-adjusted relative risk (95% confidence interval) of severe OSA (AHI ≥ 30 events/h) was 0.45 (0.23-0.87) in the 5%-10%WLG and 0.32 (0.17-0.64) in the ≥ 10%WLG; the risk was also lower in the ≥ 10%WLG vs the < 5%WLG (0.42 [0.22-0.82]). Insomnia and daytime sleepiness also improved more in participants exhibiting ≥ 5% weight loss.
CONCLUSIONS


Even a < 5% weight loss can reduce respiratory events, but a ≥ 5% and ideally ≥ 10% weight loss is necessary for reducing the prevalence of severe OSA.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT02515357; Identifier: NCT02515357.
CITATION


Georgoulis M, Yiannakouris N, Kechribari I, et al. Dose-response relationship between weight loss and improvements in obstructive sleep apnea severity after a diet/lifestyle intervention: secondary analyses of the ""MIMOSA"" randomized clinical trial.  J Clin Sleep Med . 2022;18(5):1251-1261.",2022,"Median percent change in apnea-hypopnea index (AHI) was -11.7%, -37.9% and -49.3% in the <5%WLG, 5-10%WLG and ≥10%WLG, respectively (P<0.001).","['obstructive sleep apnea (OSA', '180 adult, overweight/obese moderate-to-severe OSA patients']","['Mediterranean Diet/Lifestyle Intervention', 'diet/lifestyle intervention', 'Mediterranean diet or a Mediterranean lifestyle arm', 'continuous positive airway pressure (CPAP), while intervention arms additionally participated in a weight-loss dietary/lifestyle intervention']","['Polysomnographic data and OSA symptoms', 'obstructive sleep apnea severity', 'apnea-hypopnea index (AHI', 'Insomnia and daytime sleepiness', 'weight loss and OSA severity improvement', 'Respiratory events and oximetry indices', 'respiratory events', 'degree of weight loss', 'severe OSA']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",180.0,0.118356,"Median percent change in apnea-hypopnea index (AHI) was -11.7%, -37.9% and -49.3% in the <5%WLG, 5-10%WLG and ≥10%WLG, respectively (P<0.001).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Georgoulis', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Sciences & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Yiannakouris', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Sciences & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kechribari', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Sciences & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Kallirroi', 'Initials': 'K', 'LastName': 'Lamprou', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Perraki', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Vagiakis', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Meropi D', 'Initials': 'MD', 'LastName': 'Kontogianni', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Sciences & Education, Harokopio University, Athens, Greece.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9834']
312,34922061,Upregulated NLRP3 inflammasome activation is attenuated by anthocyanins in patients with nonalcoholic fatty liver disease: A case-control and an intervention study.,"OBJECTIVES


Despite the recent attention focused on the roles of the NLRP3 inflammasome in the pathogenesis of metabolic and inflammatory diseases, little is known about the activation status of NLRP3 inflammasome in patients with nonalcoholic fatty liver disease (NAFLD). The present study aimed to investigate whether inflammasomes activation is upregulated in patients with NAFLD and the upregulation can be attenuated by anthocyanins, which are polyphenols with known anti-inflammatory activities.
METHODS


This study included a case-control study and a randomized controlled intervention trial. In the first part, NAFLD patients and healthy controls were recruited from a cohort of railroad workers. In the second part, NAFLD patients were randomly assigned to receive either capsules of anthocyanins (320 mg daily) or placebo for 12 weeks. A series of genes and factors associated with activation of NLRP3 inflammasome in subjects' plasma and peripheral blood mononuclear cells (PBMCs) were analyzed.
RESULTS


Compared with healthy controls, the mRNA levels of NLRP3 inflammasome components (NLRP3, caspase-1, interleukin (IL)-1β, and IL-18) were significantly upregulated in the PBMCs of NAFLD patients. Consistently, plasma levels of mature IL-1β and IL-18 in NAFLD patients were significantly higher than in controls. After anthocyanin administration, both mRNA expression of NLRP3 inflammasome components (caspase-1, IL-1β, and IL-18) in PBMCs and plasma levels of IL-1β and IL-18 decreased dramatically in NAFLD patients compared with controls.
CONCLUSIONS


This study has demonstrated that the activation of NLRP3 inflammasome is highly increased in NAFLD patients, but it can be markedly suppressed by anthocyanins, which provides a rationale for the development of anti-inflammatory therapies in NAFLD.",2022,"Compared with healthy controls, the mRNA levels of NLRP3 inflammasome components (NLRP3, caspase-1, interleukin (IL)-1β, and IL-18) were significantly upregulated in the PBMCs of NAFLD patients.","['patients with nonalcoholic fatty liver disease', 'NAFLD patients', 'patients with NAFLD', 'NAFLD patients and healthy controls were recruited from a cohort of railroad workers', 'patients with nonalcoholic fatty liver disease (NAFLD']","['placebo', 'capsules of anthocyanins']","['mRNA expression of NLRP3 inflammasome components (caspase-1, IL-1β, and IL-18) in PBMCs and plasma levels of IL-1β and IL-18', 'peripheral blood mononuclear cells (PBMCs', 'plasma levels of mature IL-1β and IL-18', 'mRNA levels of NLRP3 inflammasome components (NLRP3, caspase-1, interleukin (IL)-1β, and IL-18']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0034638', 'cui_str': 'Railroads'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C2936529', 'cui_str': 'Inflammasome'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0534519', 'cui_str': 'Caspase-1'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",,0.166919,"Compared with healthy controls, the mRNA levels of NLRP3 inflammasome components (NLRP3, caspase-1, interleukin (IL)-1β, and IL-18) were significantly upregulated in the PBMCs of NAFLD patients.","[{'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan 523808, China.'}, {'ForeName': 'Xiaozhuan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan 523808, China.'}, {'ForeName': 'Peiwen', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan 523808, China.'}, {'ForeName': 'Yongji', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition, Henry Fok School of Foods, Shaoguan University, Shaoguan 512005, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, Guangzhou 510080, China.'}, {'ForeName': 'Honghui', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan 523808, China; Dongguan Key Laboratory of Environmental Medicine, Guangdong Medical University, Dongguan 523808, China. Electronic address: guohh1999@gdmu.edu.cn.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2021.101843']
313,34924237,The relationship between symptom onset-to-needle time and ischemic outcomes in patients with acute myocardial infarction treated with primary PCI: Observations from Prague-18 Study.,"OBJECTIVES


Based on previous studies with clopidogrel, the time between acute myocardial infarction (AMI) symptoms onset and primary percutaneous coronary intervention (PCI) was proven as important prognostic factor. Our aim was to assess the relationship between symptoms onset to needle time (SNT) and procedural results and the occurrence of ischemic endpoints in primary angioplasty patients treated with potent P2Y12 inhibitors.
METHODS


A total of 1,131 out of 1,230 patients randomized to the Prague-18 study (prasugrel vs. ticagrelor in primary PCI) were divided into a high and a low-risk group. The effect of defined SNT on patients' ischemic endpoints and prognosis by their risk status at admission was tested.
RESULTS


The median SNT was 3.2 hours. Longer SNTs resulted in a more frequent incidence of TIMI flow <3 post PCI (p=0.015). There were significant differences in the occurrence of the combined ischemic endpoint among the compared SNT groups at 30 days (p=0.032), and 1 year (p=0.011), with the highest incidence in the ≤1 h SNT group of patients. ""Latecomers"" (SNT>4 hs) in the high-risk group experienced more reinfarction within 1 year [OR (95% CI) 3.23 (1.09-9.62) p=0.035]; no difference was found in the low-risk group.
CONCLUSIONS


In the era of intense antithrombotic medication, stratification of MI patients undergoing primary angioplasty, based on initial ischemic risk assessment affected prognosis more than symptom onset to needle time. Longer time delay was significantly related to increased incidence of ischemic events and all-cause mortality only in patients with high ischemic risk.",2022,Longer SNTs resulted in a more frequent incidence of TIMI flow <3 post PCI (p=0.015).,"['primary angioplasty patients treated with potent P2Y12 inhibitors', 'patients with high ischemic risk', 'patients with acute myocardial infarction treated with primary PCI', 'A total of 1,131 out of 1,230 patients randomized to the Prague-18 study ', 'in primary PCI', 'MI patients undergoing primary angioplasty']","['percutaneous coronary intervention (PCI', 'SNT', 'clopidogrel', 'prasugrel vs. ticagrelor']","['occurrence of the combined ischemic endpoint', 'incidence of\xa0ischemic events', 'reinfarction', 'median SNT', 'TIMI flow <3 post PCI']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",1230.0,0.0736956,Longer SNTs resulted in a more frequent incidence of TIMI flow <3 post PCI (p=0.015).,"[{'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Hromadka', 'Affiliation': 'Department of Cardiology, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Electronic address: zuzana.motovska@lf3.cuni.cz.'}, {'ForeName': 'Ota', 'Initials': 'O', 'LastName': 'Hlinomaz', 'Affiliation': ""First Department of Internal Medicine - Cardioangiology, International Clinical Research Center, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'Department of Internal Medicine and Cardiology, Faculty of Medicine of Masaryk University and University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Varvarovsky', 'Affiliation': 'Cardiology Centre AGEL, Pardubice, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Dusek', 'Affiliation': 'First Department of Internal Medicine, University Hospital Hradec Kralove, Charles University in Prague, Faculty of Medicine in Hradec Kralove, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Svoboda', 'Affiliation': 'Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Jarkovsky', 'Affiliation': 'Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Tousek', 'Affiliation': 'Cardiocenter - Department of Cardiology, Regional Hospital, Ceske Budejovice, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'Department of Anesthesiology and Resuscitation, University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Simek', 'Affiliation': 'Second Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Branny', 'Affiliation': 'AGEL Research and Training Institute, Trinec Branch, Cardiovascular Center, Podlesi Hospital, Trinec, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mrozek', 'Affiliation': 'Cardiovascular Department, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Miklik', 'Affiliation': 'Department of Internal Medicine and Cardiology, Faculty of Medicine of Masaryk University and University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rokyta', 'Affiliation': 'Department of Cardiology, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimsky', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}]",Journal of cardiology,['10.1016/j.jjcc.2021.11.015']
314,34932102,A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine.,"BACKGROUND


Protection against human respiratory syncytial virus (RSV) remains an unmet need potentially addressable by maternal immunization. This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B.
METHODS


Adults 18-49 years old (N = 618) were randomized to receive placebo or 60, 120, or 240 µg RSVpreF with or without Al(OH)3. Safety and immunogenicity were evaluated.
RESULTS


RSVpreF recipients more frequently reported local reactions and systemic events than placebo recipients; these were mostly mild or moderate. No vaccine-related serious adverse events occurred through 12 months postvaccination. All RSVpreF formulations induced 1-month postvaccination virus-neutralizing titers higher than those associated with protection of high-risk infants by palivizumab, the only prophylactic currently available for RSV. Geometric mean fold rises (GMFRs) across RSVpreF doses/formulations were 10.6-16.9 for RSV A and 10.3-19.8 for RSV B at 1 month postvaccination, greater than those historically elicited by postfusion F vaccines. GMFRs were 3.9-5.2 and 3.7-5.1, respectively, at 12 months postvaccination.
CONCLUSIONS


RSVpreF formulations were safe, well tolerated, and induced robust neutralizing responses in adults. These findings support development of RSVpreF, which is being evaluated in a pivotal phase 3 study for maternal immunization.
CLINICAL TRIALS REGISTRATION


NCT03529773.",2022,"All RSVpreF formulations induced 1-month postvaccination virus-neutralizing titers higher than those associated with protection of high-risk infants by palivizumab, the only prophylactic currently available for RSV.",['Adults 18-49 years old (N=618'],"['placebo', 'RSVpreF with or without Al(OH)3', 'bivalent prefusion F vaccine (RSVpreF', 'palivizumab', 'Respiratory Syncytial Virus Prefusion F Vaccine']","['local reactions and systemic events', 'GMFRs', 'Safety and immunogenicity', 'safe, well tolerated', 'Geometric mean fold rises (GMFRs', 'serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0672596', 'cui_str': 'palivizumab'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}]","[{'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",618.0,0.211507,"All RSVpreF formulations induced 1-month postvaccination virus-neutralizing titers higher than those associated with protection of high-risk infants by palivizumab, the only prophylactic currently available for RSV.","[{'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': 'Department of Medicine, Infectious Diseases Division, Rochester General Hospital and University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': 'Department of Medicine, Infectious Diseases Division, Rochester General Hospital and University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Agnieszka M', 'Initials': 'AM', 'LastName': 'Zareba', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Radley', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Gomme', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Schmoele-Thoma', 'Affiliation': 'Vaccine Research and Development, Pfizer Pharma, GmbH, Berlin, Germany.'}]",The Journal of infectious diseases,['10.1093/infdis/jiab612']
315,34906007,The Effect of Transcultural Nursing Course on Students' Moral Sensitivity: A Quasi-Experimental Study.,"INTRODUCTION


The moral sensitivity of nurses positively affects the quality of patient care. For this reason, nursing students are expected to gain moral sensitivity skills during their education. The aim of the study is to examine the impact of transcultural nursing course (TNC) on the moral sensitivity levels of students.
METHODS


This study had a quasi-experimental design. The sample consisted of 100 nursing students (intervention: 36 and control: 64). The intervention group was composed of students who had enrolled in the TNC. The data were collected through the Sociodemographic Information Form and the Moral Sensitivity Questionnaire. Independent samples t-test and analysis of variance were used in data analysis.
RESULTS


The moral sensitivity levels of the students who received the TNC were significantly higher than those who did not.
DISCUSSION


The TNC is an effective teaching method in increasing the moral sensitivity levels of nursing students.",2022,"The moral sensitivity levels of the students who received the TNC were significantly higher than those who did not.
","['students', ""Students' Moral Sensitivity"", '100 nursing students (intervention: 36 and control: 64', 'students who had enrolled in the TNC']","['Transcultural Nursing Course', 'TNC', 'transcultural nursing course (TNC']",['moral sensitivity levels'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085288', 'cui_str': 'Nursing, Transcultural'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0085288', 'cui_str': 'Nursing, Transcultural'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",100.0,0.0434327,"The moral sensitivity levels of the students who received the TNC were significantly higher than those who did not.
","[{'ForeName': 'Cevriye', 'Initials': 'C', 'LastName': 'Yüksel Kaçan', 'Affiliation': 'Bursa Uludağ University, Turkey.'}]",Journal of transcultural nursing : official journal of the Transcultural Nursing Society,['10.1177/10436596211063813']
316,34915725,Preliminary Effectiveness of Group Interpersonal Psychotherapy for Young Kenyan Mothers With HIV and Depression: A Pilot Trial.,"OBJECTIVE


The authors adopted a task-sharing strategy in which lay health workers delivered group interpersonal psychotherapy (IPT-G) in primary care clinics in Nairobi, Kenya, to young mothers with HIV and depression. The study examined the acceptability, feasibility, and effectiveness of IPT-G in improving depression and antiretroviral therapy adherence.
METHODS


Twenty-four mothers (ages 18-24 years and 6-12 weeks postpartum) participated. The women were randomly assigned to IPT-G or to a waitlist. Eight lay providers administered the IPT-G sessions across 8 weeks. The primary outcome was pre- to postintervention change in depression scores as measured on the Edinburgh Postnatal Depression Scale. The secondary outcome was antiretroviral therapy adherence. All waitlist participants subsequently received the intervention, and a secondary outcome, within-group analysis, was conducted and included those participants.
RESULTS


Participants' median age was 23.0 years, 17 (71%) lived with a partner, and 19 (79%) had fewer than two children. The intervention group had a mean±SD depression score of 15.9±4.3 at baseline and 6.8±7.0 postintervention. For the waitlist control group, the mean score was 17.3±5.9 at baseline and 13.2±6.6 at the first follow-up. Waitlist participants had significantly greater mean depression scores than did intervention group participants at the first follow-up (after the intervention group's 8-week IPT-G) (β=6.42, 95% confidence interval=1.17 to 11.66, p=0.017). No difference was observed between groups in antiretroviral therapy adherence.
CONCLUSIONS


This study provides preliminary evidence that IPT-G led by community health workers may have benefits for postpartum depression among young mothers with HIV.",2022,This study provides preliminary evidence that IPT-G led by community health workers may have benefits for postpartum depression among young mothers with HIV.,"['Young Kenyan Mothers With HIV and Depression', 'primary care clinics in Nairobi, Kenya, to young mothers with HIV and depression', 'young mothers with HIV', ""Participants' median age was 23.0 years, 17 (71%) lived with a partner, and 19 (79%) had fewer than two children"", 'Twenty-four mothers (ages 18-24 years and 6-12 weeks postpartum) participated']","['interpersonal psychotherapy (IPT-G', 'IPT-G or to a waitlist', 'IPT-G', 'Group Interpersonal Psychotherapy']","['mean depression scores', 'mean score', 'pre- to postintervention change in depression scores as measured on the Edinburgh Postnatal Depression Scale', 'antiretroviral therapy adherence', 'mean±SD depression score']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.1439,This study provides preliminary evidence that IPT-G led by community health workers may have benefits for postpartum depression among young mothers with HIV.,"[{'ForeName': 'Obadia', 'Initials': 'O', 'LastName': 'Yator', 'Affiliation': 'Department of Psychiatry, School of Medicine, College of Health Sciences, University of Nairobi, Nairobi, Kenya (Yator, Khasakhala, Kumar); Departments of Global Health, Medicine, Epidemiology, and Pediatrics, University of Washington, Seattle (John-Stewart); Department of Psychology, University College London, London (Kumar).'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Psychiatry, School of Medicine, College of Health Sciences, University of Nairobi, Nairobi, Kenya (Yator, Khasakhala, Kumar); Departments of Global Health, Medicine, Epidemiology, and Pediatrics, University of Washington, Seattle (John-Stewart); Department of Psychology, University College London, London (Kumar).'}, {'ForeName': 'Lincoln', 'Initials': 'L', 'LastName': 'Khasakhala', 'Affiliation': 'Department of Psychiatry, School of Medicine, College of Health Sciences, University of Nairobi, Nairobi, Kenya (Yator, Khasakhala, Kumar); Departments of Global Health, Medicine, Epidemiology, and Pediatrics, University of Washington, Seattle (John-Stewart); Department of Psychology, University College London, London (Kumar).'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Psychiatry, School of Medicine, College of Health Sciences, University of Nairobi, Nairobi, Kenya (Yator, Khasakhala, Kumar); Departments of Global Health, Medicine, Epidemiology, and Pediatrics, University of Washington, Seattle (John-Stewart); Department of Psychology, University College London, London (Kumar).'}]",American journal of psychotherapy,['10.1176/appi.psychotherapy.20200050']
317,34933570,Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial.,"BACKGROUND


Observational data suggest that catheter ablation may be safe and effective to treat younger and older patients with atrial fibrillation. No large, randomized trial has examined this issue. This report describes outcomes according to age at entry in the CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation).
METHODS


Patients with atrial fibrillation ≥65 years of age, or <65 with ≥1 risk factor for stroke, were randomly assigned to catheter ablation versus drug therapy. The primary outcome was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Secondary outcomes included all-cause mortality, the composite of mortality or cardiovascular hospitalization, and recurrence of atrial fibrillation. Treatment effect estimates were adjusted for baseline covariables using proportional hazards regression models.
RESULTS


Of 2204 patients randomly assigned in CABANA, 766 (34.8%) were <65 years of age, 1130 (51.3%) were 65 to 74 years of age, and 308 (14.0%) were ≥75 years of age. Catheter ablation was associated with a 43% reduction in the primary outcome for patients <65 years of age (adjusted hazard ratio [aHR], 0.57 [95% CI, 0.30-1.09]), a 21% reduction for 65 to 74 years of age (aHR, 0.79 [95% CI, 0.54-1.16]), and an indeterminate effect for age ≥75 years of age (aHR, 1.39 [95% CI, 0.75-2.58]). Four-year event rates for ablation versus drug therapy across age groups, respectively, were 3.2% versus 7.8%, 7.8% versus 9.6%, and 14.8% versus 9.0%. For every 10-year increase in age, the primary outcome aHR increased (ie, less favorable to ablation) an average of 27% (interaction  P  value=0.215). A similar pattern was seen with all-cause mortality: for every 10-year increase in age, the aHR increased an average of 46% (interaction  P  value=0.111). Atrial fibrillation recurrence rates were lower with ablation than with drug therapy across age subgroups (aHR 0.47, 0.58, and 0.49, respectively). Treatment-related complications were infrequent for both arms (<3%) regardless of age.
CONCLUSIONS


We found age-based variations in clinical outcomes for catheter ablation compared with drug therapy, with the largest relative and absolute benefits of catheter ablation in younger patients. No prognostic benefits for ablation were seen in the oldest patients. No differences were found by age in treatment-related complications or in the relative effectiveness of catheter ablation in preventing recurrent atrial arrhythmias.
REGISTRATION


URL: https://www.
CLINICALTRIALS


gov; Unique identifier: NCT00911508.",2022,No differences were found by age in treatment-related complications or in the relative effectiveness of catheter ablation in preventing recurrent atrial arrhythmias.,"['2204 patients randomized in CABANA, 766 (34.8%) were age <65, 1130 (51.3%) were 65-74, and 308 (14.0%) were ≥75', 'Atrial Fibrillation', 'younger and older patients with atrial fibrillation (AF', 'younger patients', 'Patients with AF age ≥65, or <65 with ≥1 risk factor for stroke']","['Catheter Ablation vs Antiarrhythmic Drug Therapy', 'catheter ablation', 'Catheter Ablation Versus Medical Therapy', 'catheter ablation versus drug therapy']","['AF recurrence rates', 'mortality', 'Catheter ablation', 'cause mortality, the composite of mortality or cardiovascular hospitalization, and recurrence of AF', 'aHR', 'composite of death, disabling stroke, serious bleeding, or cardiac arrest', 'recurrent atrial arrhythmias']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1312385', 'cui_str': 'AHR protein, human'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}]",2204.0,0.244227,No differences were found by age in treatment-related complications or in the relative effectiveness of catheter ablation in preventing recurrent atrial arrhythmias.,"[{'ForeName': 'Tristram D', 'Initials': 'TD', 'LastName': 'Bahnson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (T.D.B., A.G., D.B.M., H.R.A.-K., A.P.S., K.L.L.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Giczewska', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (T.D.B., A.G., D.B.M., H.R.A.-K., A.P.S., K.L.L.).'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (T.D.B., A.G., D.B.M., H.R.A.-K., A.P.S., K.L.L.).'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Russo', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (T.D.B., A.G., D.B.M., H.R.A.-K., A.P.S., K.L.L.).'}, {'ForeName': 'Kristi H', 'Initials': 'KH', 'LastName': 'Monahan', 'Affiliation': 'Mayo Clinic, Rochester, MN (K.H.M., D.L.P.).'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (T.D.B., A.G., D.B.M., H.R.A.-K., A.P.S., K.L.L.).'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Silverstein', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (T.D.B., A.G., D.B.M., H.R.A.-K., A.P.S., K.L.L.).'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington Medical Center, Seattle (J.E.P.).'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (T.D.B., A.G., D.B.M., H.R.A.-K., A.P.S., K.L.L.).'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Packer', 'Affiliation': 'Mayo Clinic, Rochester, MN (K.H.M., D.L.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.121.055297']
318,34913842,The Effects of tDCS with NDT on the Improvement of Motor Development in Cerebral Palsy.,"We investigated the effects of transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) with neurodevelopmental treatment (NDT) on the improvement of motor development and reduction of spasticity in children with cerebral palsy (CP). Twenty-four children with CP were allocated to two groups: the tDCS + NDT group and the only NDT group, done 3 times per week for 5 weeks. The Gross Motor Function Measurement (GMFM-88) and Box and Block Test (BBT) were used to assess changes in motor development, and the Modified Ashworth Scale (MAS) was used to evaluate changes in spasticity. All measurements were carried out at 3 time points: baseline, post-intervention, and 1 month follow-up. We found improvements in the GMFM-88 total scores and in each individual GMFM-88 dimension scores, favoring the tDCS + NDT group over the only NDT group. The BBT scores improved only in the tDCS + NDT group. In addition, the MAS scores reduced in the hemibody with significant motor impairment only in the tDCS + NDT group. The present findings suggest that tDCS combined with NDT can be considered a promising intervention for children with CP, as it can enhance motor development and reduce spasticity in this population.",2022,"We found improvements in the GMFM-88 total scores and in each individual GMFM-88 dimension scores, favoring the tDCS + NDT group over the only NDT group.","['children with CP', 'Twenty-four children with CP', 'children with cerebral palsy (CP', 'Cerebral Palsy']","['neurodevelopmental treatment (NDT', 'tDCS\u2009+\u2009NDT', 'transcranial direct current stimulation (tDCS', 'tDCS with NDT', 'tDCS combined with NDT']","['GMFM-88 total scores', 'BBT scores', 'MAS scores', 'changes in motor development, and the Modified Ashworth Scale (MAS', 'Gross Motor Function Measurement (GMFM-88) and Box and Block Test (BBT']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0717511,"We found improvements in the GMFM-88 total scores and in each individual GMFM-88 dimension scores, favoring the tDCS + NDT group over the only NDT group.","[{'ForeName': 'Jhosedyn Carolaym', 'Initials': 'JC', 'LastName': 'Salazar Fajardo', 'Affiliation': 'Major of Rehabilitation Science, Graduate School, Korea University, Seoul, Korea.'}, {'ForeName': 'RockHyun', 'Initials': 'R', 'LastName': 'Kim', 'Affiliation': 'Major of Rehabilitation Science, Graduate School, Korea University, Seoul, Korea.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Health Sciences, Graduate School, Korea University, Seoul, Korea.'}, {'ForeName': 'JiYeon', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': ""Purme Foundation, NEXON Children's Rehabilitation Hospital, Seoul, Korea.""}, {'ForeName': 'JinKyu', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Purme Foundation, NEXON Children's Rehabilitation Hospital, Seoul, Korea.""}, {'ForeName': 'DongGil', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""King's Kids Center, Seoul, Korea.""}, {'ForeName': 'BumChul', 'Initials': 'B', 'LastName': 'Yoon', 'Affiliation': 'Major of Rehabilitation Science, Graduate School, Korea University, Seoul, Korea.'}]",Journal of motor behavior,['10.1080/00222895.2021.2016572']
319,34923180,Effect of camrelizumab plus transarterial chemoembolization on massive hepatocellular carcinoma.,"OBJECTIVE


To investigate the efficacy of camrelizumab plus transarterial chemoembolization (TACE) on massive hepatocellular carcinoma (HCC) patients.
METHODS


A total of 92 cases with massive HCC from October 2019 to January 2021 were prospectively enrolled and randomly divided into the study group (n = 46) and the control group (n = 46). The control group received TACE while the study group were treated with camrelizumab plus TACE. The primary end points were clinical efficacy and adverse events. And the secondary end points were liver function, and alpha fetoprotein (AFP), carcino-embryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9) levels before and after treatment.
RESULTS


All participants were followed-up for 7 to 24 months, with a median of 12 months. Patients in the study group received TACE for 1-3 times, with an average of (2.01 ± 0.09) times, while patients in the control group receive TACE for 2-4 times, with an average of (3.78 ± 0.12) times, and the control group received significantly more TACEs (χ 2  = 5.518, P = 0.019). During the follow-up, the response rate and disease control rate of the study group were significantly higher than those of the control group (χ 2  = 5.518, P = 0.019; χ 2  = 4.467, P = 0.041). Before treatment, the levels of total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alpha-fetoprotein (AFP), CEA, and CA19-9 were comparable between the groups (P > 0.05). After treatment, the levels of TBIL, ALT, AST, AFP, CEA, and CA19-9 decreased, and the above indicators in the study group were significantly lower than those in the control group (P < 0.05). All patients showed transient liver damage, vomiting, nausea, fever and abdominal pain after surgery, and their symptoms were relieved after symptomatic treatment. Adverse events occurred in 9 cases in the study group, and 3 cases in the control group (χ 2  = 3.419, P = 0.064).
CONCLUSION


Compared with TACE alone, camrelizumab plus TACE treatment can significantly improve the liver function of patients with massive HCC and enhance the treatment effect, which is worthy of clinical promotion.",2022,"After treatment, the levels of TBIL, ALT, AST, AFP, CEA, and CA19-9 decreased, and the above indicators in the study group were significantly lower than those in the control group (P<0.05).","['massive hepatocellular carcinoma', 'massive hepatocellular carcinoma (HCC) patients', '92 cases with massive HCC from October 2019 to January 2021']","['TACE alone, camrelizumab plus TACE', 'camrelizumab plus TACE', 'TACE', 'camrelizumab plus transarterial chemoembolization (TACE', 'camrelizumab plus transarterial chemoembolization']","['transient liver damage, vomiting, nausea, fever and abdominal pain', 'levels of total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alpha-fetoprotein (AFP), CEA, and CA19-9', 'response rate and disease control rate', 'liver function', 'levels of TBIL, ALT, AST, AFP, CEA, and CA19-9 decreased, and the above indicators', 'Adverse events', 'liver function, and alpha fetoprotein (AFP), carcino-embryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9) levels', 'clinical efficacy and adverse events']","[{'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",92.0,0.0571127,"After treatment, the levels of TBIL, ALT, AST, AFP, CEA, and CA19-9 decreased, and the above indicators in the study group were significantly lower than those in the control group (P<0.05).","[{'ForeName': 'Sujing', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Changwen', 'Initials': 'C', 'LastName': 'Bo', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Changwang', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China. Electronic address: 1057076160@qq.com.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2021.101851']
320,34931667,"Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine.","BACKGROUND


Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults and adults with comorbidities. An effective vaccine is needed. An investigational bivalent prefusion F vaccine (RSVpreF) was assessed in healthy adults.
METHODS


This phase 1/2 study randomized adults 18-85 years old to receive placebo or 60, 120, or 240 µg RSVpreF (with or without aluminum hydroxide) alone or concomitantly with seasonal inactivated influenza vaccine (SIIV). Safety and immunogenicity were assessed.
RESULTS


In older adults, reactogenicity events were predominantly mild or moderate among RSVpreF recipients; adverse events through 1 month postvaccination were similar across formulations. Coadministration with SIIV did not appear to affect safety among younger or older adults. All RSVpreF formulations with or without concomitant SIIV elicited robust RSV serum-neutralizing responses in adults aged 50-85 years 1 month postvaccination. Neutralizing titers 1 and 12 months postvaccination were 6.9-14.9 and 2.9-4.5 times, respectively, those before vaccination. SIIV immune responses trended lower when coadministered with RSVpreF.
CONCLUSIONS


RSVpreF formulations administered alone or with SIIV were well tolerated and highly immunogenic in older adults, supporting the potential for RSVpreF to protect older adults from RSV disease.
CLINICAL TRIALS REGISTRATION


NCT03529773.",2022,All RSVpreF formulations with or without concomitant SIIV elicited robust RSV serum neutralizing responses in adults 50-85 years 1 month postvaccination.,"['older adults', 'older adults and adults with comorbidities', 'Adults With Concomitant Inactivated Influenza Vaccine', 'adults 18-85 years old to receive', 'younger or older adults', 'healthy adults', 'or 60, 120, or 240 µg']","['placebo', 'RSVpreF (with or without Al[OH]3) alone or concomitantly with seasonal inactivated influenza vaccine (SIIV', 'RSV Prefusion F Vaccine', 'investigational bivalent prefusion F vaccine (RSVpreF']","['SIIV immune responses', 'Neutralizing titers', 'RSV serum neutralizing responses', 'Safety and immunogenicity', 'Immunogenicity, Safety and Tolerability', 'reactogenicity events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0077287', 'cui_str': 'tris(acetylacetonate) aluminum(III)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1691781', 'cui_str': 'Reactogenicity event'}]",,0.114299,All RSVpreF formulations with or without concomitant SIIV elicited robust RSV serum neutralizing responses in adults 50-85 years 1 month postvaccination.,"[{'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': 'Department of Medicine, Infectious Diseases Division, Rochester General Hospital and University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': 'Department of Medicine, Infectious Diseases Division, Rochester General Hospital and University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Zareba', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Gomme', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Schmoele-Thoma', 'Affiliation': 'Vaccine Research and Development, Pfizer Pharma GMbH, Berlin, Germany.'}]",The Journal of infectious diseases,['10.1093/infdis/jiab611']
321,34918330,"Neonatal Birthweight, Infant Feeding, and Childhood Metabolic Markers.","OBJECTIVE


Antenatal and early neonatal nutritional environment may influence later metabolic health. Infants of mothers with gestational diabetes mellitus (GDM) have higher risk for childhood obesity and metabolic syndrome (MetS). Leptin and adiponectin are known biomarkers for MetS and may guide interventions to reduce later obesity. We sought to examine the relationship between birthweight, early infancy feeding practices, and biomarkers for MetS in offspring of women with mild GDM.
STUDY DESIGN


Secondary analysis of a prospective observational follow-up study on the offspring of women who participated in a multicenter randomized treatment trial on mild GDM. Children were evaluated by research coordinators and biospecimens collected at the age of 5 to 10. Plasma concentrations of leptin and adiponectin were compared between large for gestational age (LGA) and average birthweight (AGA) infants, and according to whether solid foods were introduced early (<6 months of age) or at the recommended age (≥6 months of age). Multivariable analysis adjusted for fetal sex, race/ethnicity, and maternal body mass index.
RESULTS


Leptin and adiponectin were measured in 336 plasma samples. In bivariate analysis, compared with AGA children, LGA children had lower leptin (5.0 ng/mL [3.6-6.0] vs. 5.8 ng/mL [4.5 = 6.6],  p  = 0.01) and similar adiponectin (6.3 µg/mL [5.1-7.9] vs. 6.4 µg/mL [5.3-8.6],  p  = 0.49) concentrations. Maternal/child characteristics were similar between the early/delayed solid feeding groups. Leptin and adiponectin concentrations were similar in the early fed and delayed feeding groups (5.8 ng/mL [4.6-6.7] vs. 5.6 ng/mL [4.2-6.6],  p  = 0.50 and 6.4 µg/mL [5.4-8.1] vs. 6.4 µg/mL [5.1-8.8],  p  = 0.85, respectively). After controlling for covariates, children who were LGA and AGA at birth had similar leptin concentrations.
CONCLUSION


Birthweight and early infancy feeding practice are not associated with alterations in leptin and adiponectin in children of women with mild GDM.
KEY POINTS


· Adipocytokines are markers of metabolic status.. · Children of women with mild GDM may be at risk for MetS.. · Biomarkers similar in LGA and AGA groups.. · Biomarkers similar in early and delayed solid-fed groups.. · Nonhuman milk does not modify effect of feeding practice..",2022,"Birthweight and early infancy feeding practice are not associated with alterations in leptin and adiponectin in children of women with mild GDM.
","['children of women with mild GDM', 'Infants of mothers with gestational diabetes mellitus (GDM', 'offspring of women who participated in a multicenter randomized treatment trial on mild GDM']",[],"['Plasma concentrations of leptin and adiponectin', 'similar adiponectin', 'Maternal/child characteristics', 'Leptin and adiponectin concentrations', 'Leptin and adiponectin', 'leptin', 'Neonatal Birthweight, Infant Feeding, and Childhood Metabolic Markers']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}]",,0.0301931,"Birthweight and early infancy feeding practice are not associated with alterations in leptin and adiponectin in children of women with mild GDM.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pippen', 'Affiliation': 'Department of Obstetrics and Gynecology of The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stetson', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Doherty', 'Affiliation': 'Department of Obstetrics and Gynecology, The George Washington University Biostatistics Center, Washington, Dist. of Columbia.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': 'Department of Obstetrics and Gynecology, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Maryland.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': ""University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0041-1740056']
322,34928310,Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial.,"Importance


In adults undergoing hip fracture surgery, regional anesthesia may reduce postoperative delirium, but there is uncertainty about its effectiveness.
Objective


To investigate, in older adults undergoing surgical repair for hip fracture, the effects of regional anesthesia on the incidence of postoperative delirium compared with general anesthesia.
Design, Setting, and Participants


A randomized, allocation-concealed, open-label, multicenter clinical trial of 950 patients, aged 65 years and older, with or without preexisting dementia, and a fragility hip fracture requiring surgical repair from 9 university teaching hospitals in Southeastern China. Participants were enrolled between October 2014 and September 2018; 30-day follow-up ended November 2018.
Interventions


Patients were randomized to receive either regional anesthesia (spinal, epidural, or both techniques combined with no sedation; n = 476) or general anesthesia (intravenous, inhalational, or combined anesthetic agents; n = 474).
Main Outcomes and Measures


Primary outcome was incidence of delirium during the first 7 postoperative days. Secondary outcomes analyzed in this article include delirium severity, duration, and subtype; postoperative pain score; length of hospitalization; 30-day all-cause mortality; and complications.
Results


Among 950 randomized patients (mean age, 76.5 years; 247 [26.8%] male), 941 were evaluable for the primary outcome (6 canceled surgery and 3 withdrew consent). Postoperative delirium occurred in 29 (6.2%) in the regional anesthesia group vs 24 (5.1%) in the general anesthesia group (unadjusted risk difference [RD], 1.1%; 95% CI, -1.7% to 3.8%; P = .48; unadjusted relative risk [RR], 1.2 [95% CI, 0.7 to 2.0]; P = .57]). Mean severity score of delirium was 23.0 vs 24.1, respectively (unadjusted difference, -1.1; 95% CI, -4.6 to 3.1). A single delirium episode occurred in 16 (3.4%) vs 10 (2.1%) (unadjusted RD, 1.1%; 95% CI, -1.7% to 3.9%; RR, 1.6 [95% CI, 0.7 to 3.5]). Hypoactive subtype in 11 (37.9%) vs 5 (20.8%) (RD, 11.5; 95% CI, -11.0% to 35.7%; RR, 2.2 [95% CI, 0.8 to 6.3]). Median worst pain score was 0 (IQR, 0 to 20) vs 0 (IQR, 0 to 10) (difference 0; 95% CI, 0 to 0). Median length of hospitalization was 7 days (IQR, 5 to 10) vs 7 days (IQR, 6 to 10) (difference 0; 95% CI, 0 to 0). Death occurred in 8 (1.7%) vs 4 (0.9%) (unadjusted RD, -0.8%; 95% CI, -2.2% to 0.7%; RR, 2.0 [95% CI, 0.6 to 6.5]). Adverse events were reported in 106 episodes in the regional anesthesia group and 102 in the general anesthesia group; the most frequently reported adverse events were nausea and vomiting (47 [44.3%] vs 34 [33.3%]) and postoperative hypotension (13 [12.3%] vs 10 [9.8%]).
Conclusions and Relevance


In patients aged 65 years and older undergoing hip fracture surgery, regional anesthesia without sedation did not significantly reduce the incidence of postoperative delirium compared with general anesthesia.
Trial Registration


ClinicalTrials.gov Identifier: NCT02213380.",2022,"Mean severity score of delirium was 23.0 vs 24.1, respectively (unadjusted difference, -1.1","['950 randomized patients (mean age, 76.5 years; 247 [26.8%] male', 'adults undergoing hip fracture surgery', 'older adults undergoing surgical repair for hip fracture', 'Participants were enrolled between October 2014 and September 2018; 30-day follow-up ended November 2018', 'Undergoing Hip Fracture Surgery', 'Older Patients', '950 patients, aged 65 years and older, with or without preexisting dementia, and a fragility hip fracture requiring surgical repair from 9 university teaching hospitals in Southeastern China', 'patients aged 65 years and older undergoing hip fracture surgery']","['regional anesthesia', 'Regional vs General Anesthesia', 'regional anesthesia (spinal, epidural, or both techniques combined with no sedation; n\u2009=\u2009476) or general anesthesia (intravenous, inhalational, or combined anesthetic agents; n\u2009=\u2009474', 'regional anesthesia without sedation']","['Postoperative delirium', 'incidence of postoperative delirium', 'delirium severity, duration, and subtype; postoperative pain score; length of hospitalization; 30-day all-cause mortality; and complications', 'delirium episode', 'Incidence of Postoperative Delirium', 'Death', 'nausea and vomiting', 'postoperative hypotension', 'Mean severity score of delirium', 'Adverse events', 'incidence of delirium during the first 7 postoperative days', 'Median worst pain score', 'Median length of hospitalization']","[{'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0376445', 'cui_str': 'Anesthetics, Combined'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0865752', 'cui_str': 'Postoperative hypotension'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",950.0,0.687166,"Mean severity score of delirium was 23.0 vs 24.1, respectively (unadjusted difference, -1.1","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ningbo No. 6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Jinze', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Wenzhou Medical University, The First Provincial Wenzhou Hospital of Zhejiang, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ""Clinical Research Unit, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rajnikant Laxmishanker', 'Initials': 'RL', 'LastName': 'Mehta', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Mingcang', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Warwick, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jackson', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Melody', 'Affiliation': 'University Hospitals of Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Shengwei', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Yinguang', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""Department of Anesthesia and Critical Care, Lishui Municipal People's Hospital, Lishui Central Hospital, and Fifth Affiliated Hospital of Wenzhou Medical College, Lishui, Zhejiang, China.""}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesia and Critical Care, Lishui City People's Hospital, Lishui, Zhejiang, China.""}, {'ForeName': 'Junping', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesia and Critical Care, Hwa Mei Hospital, University of Chinese Academy of Sciences, Ningbo No. 2 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Fang Gao', 'Initials': 'FG', 'LastName': 'Smith', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.22647']
323,34935709,Exercise Training Improves Mitochondrial Bioenergetics of Natural Killer Cells.,"INTRODUCTION


Mitochondrial bioenergetics is critical for immune function in natural killer (NK) cell. Physical exercise modulates NK cell functionality, depending on the intensity and type of exercise. This study elucidates how interval and continuous exercise regimens affect the phenotypes and mitochondrial bioenergetics of NK cells.
METHODS


Sixty healthy sedentary males were randomly assigned to engage in either high-intensity interval training (HIIT, 3-min intervals at 80% and 40% maximal O2, n = 20; age, 22.2 yr; body mass index [BMI], 24.3 kg·m-2) or moderate-intensity continuous training (MICT, sustained 60% maximal O2, n = 20; age, 22.3 yr; BMI, 23.3 kg·m-2) for 30 min·d-1, 5 d·wk-1 for 6 wk or were assigned to a control group that did not receive exercise intervention (n = 20; age, 22.6 yr; BMI, 24.0 kg·m-2). Natural killer cell phenotypes, granule proteins, and mitochondrial oxidative stress/oxidative phosphorylation after graded exercise test (GXT) were measured before and after the various interventions.
RESULTS


Before the intervention, the GXT increased the mobilization of CD57+NK cells into the blood and elevated mitochondrial matrix oxidant burden (MOB) in NK cells, Following the 6 wk of interventions, both HIIT and MICT (i) diminished mobilization of CD57+NK cells into the blood and depressed mitochondrial MOB level in NK cells immediately after GXT, (ii) increased mitochondrial membrane potential and cellular perforin and granzyme B levels in NK cells, and (iii) enhanced the maximal and reserve O2 consumption rates and heightened bioenergetic health index in NK cells. In addition, HIIT increased maximal work rate than those of MICT.
CONCLUSIONS


Either HIIT or MICT increases the expressions of cytotoxic granule proteins and depresses mitochondrial MOB elevated by GXT, along with improving mitochondrial bioenergetic functionality in NK cells. Moreover, HIIT is superior to MICT in improving aerobic capacity.",2022,"Either HIIT or MICT increases the expressions of cytotoxic granule proteins and depresses mitochondrial MOB elevated by GXT, along with improving mitochondrial bioenergetic functionality in NKs.",['Sixty healthy sedentary males'],"['Exercise Training', 'Physical exercise', 'high-intensity interval training', 'HIIT or MICT', 'graded exercise test (GXT', 'moderate-intensity continuous training (MICT, sustained 60% VO2max', 'control group that did not receive exercise intervention', 'MICT']","['maximal work-rate', 'mitochondrial membrane potential and cellular perforin and granzyme B levels in NKs, and (iii) enhanced the maximal and reserve O2 consumption rates and heightened bioenergetic health index', 'aerobic capacity', 'expressions of cytotoxic granule proteins and depresses mitochondrial MOB', 'HIIT and MICT (i) diminished mobilization of CD57+NKs into the blood and depressed mitochondrial MOB level', 'mobilization of CD57+NKs into the blood and elevated mitochondrial matrix oxidant burden (MOB', 'Mitochondrial Bioenergetics of Natural Killer Cells']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1720920', 'cui_str': 'Mitochondrial Membrane Potential'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0070410', 'cui_str': 'Perforin'}, {'cui': 'C0061878', 'cui_str': 'Granzyme B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205250', 'cui_str': 'High'}]",60.0,0.0281748,"Either HIIT or MICT increases the expressions of cytotoxic granule proteins and depresses mitochondrial MOB elevated by GXT, along with improving mitochondrial bioenergetic functionality in NKs.","[{'ForeName': 'Ming-Lu', 'Initials': 'ML', 'LastName': 'Lin', 'Affiliation': 'Healthy Aging Research Center, Graduate Institute of Rehabilitation Science, Medical College, Chang Gung University, Tao-Yuan, TAIWAN.'}, {'ForeName': 'Chih-Chin', 'Initials': 'CC', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Rehabilitation Science, Medical College, Chang Gung University, Kwei-Shan, TAIWAN.'}, {'ForeName': 'Tieh-Cheng', 'Initials': 'TC', 'LastName': 'Fu', 'Affiliation': 'Graduate Institute of Rehabilitation Science, Medical College, Chang Gung University, Kwei-Shan, TAIWAN.'}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Lin', 'Affiliation': 'Healthy Aging Research Center, Graduate Institute of Rehabilitation Science, Medical College, Chang Gung University, Tao-Yuan, TAIWAN.'}, {'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Therapy, College of Medical and Health Science, Asia University, Taichung, TAIWAN.'}, {'ForeName': 'Jong-Shyan', 'Initials': 'JS', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002842']
324,34935707,Stepper-Based Training Improves Monocyte-Platelet Aggregation and Thrombin Generation in Nonambulatory Hemiplegic Patients.,"PURPOSE


Nonambulatory stroke patients are extremely sedentary, but most available data concerning exercise training in stroke patients are related to ambulatory patients. This study aimed to investigate the efficacy of stepper-based exercise training on cardiopulmonary fitness, monocyte subtypes, and associated monocyte-platelet aggregates (MPA) and thrombin generation (TrG) in nonambulatory hemiplegic patients with ischemic stroke.
METHOD


Thirty-eight patients were randomized into exercise training (ET, n = 20) and usual care (UC, n = 18) groups. The ET underwent supervised exercise training (60% peak work rate) using a recumbent stepper for two to four sessions per week and 36 sessions in total. In addition, 12 healthy participants were enrolled as healthy controls. Monocyte characteristics, MPA, and plasma TrG kinetics were determined before and after intervention by flow cytometry and calibrated automated thrombogram® (CAT).
RESULTS


Seventeen and 15 patients completed the protocol in the ET and UC groups. Peak V̇O2 improved in ET (15.7 ± 4.8 vs 18.9 ± 5.3 mL·min-1·kg-1, +20%), so did the phase angle of the hemiplegic limbs. The counts of total MPA and MPA associated with three monocyte subtypes, alongside CD42b expression all declined in ET with subtypes 2 and 1 being the most prominent. Macrophage inflammatory protein 1β (MIP-1 β) level also declined. The TrG kinetics was attenuated after ET by delaying initiation and reducing the rising slope and peak of thrombin production. In UC, no difference was revealed in the pre-post comparison.
CONCLUSIONS


Stepper-based ET is feasible in nonambulatory hemiplegic patients and is effective in improving aerobic fitness. Moreover, it decreases heteroaggregation of monocytes with platelets, especially in monocyte subtypes 2 and 1. Thrombin generation was also attenuated. Hence, stepper-based ET may be incorporated in the rehabilitation of nonambulatory hemiplegic patients.",2022,"CONCLUSIONS


Stepper-based ET is feasible in non-ambulatory hemiplegic patients and is effective in improving aerobic fitness.","['12 healthy participants were enrolled as healthy controls (HC', 'Nonambulatory Hemiplegic Patients', 'non-ambulatory hemiplegic patients', 'non-ambulatory hemiplegic patients with ischemic stroke', 'Thirty-eight patients']","['thrombin generation (TrG', 'Stepper-based Training', 'supervised exercise training', 'stepper-based exercise training', 'Stepper-based ET', 'exercise training']","['counts of total MPAs and MPAs associated with three monocyte subtypes, alongside CD42b expression', 'Macrophage inflammatory protein 1β (MIP-1 β) level', 'rising slope and peak of thrombin production', 'Monocyte characteristics, MPA and plasma TrG kinetics', 'TrG kinetics', ""Peak V'O2""]","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0282604', 'cui_str': 'Lymphocyte antigen CD42b'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C2350701', 'cui_str': 'Macrophage Inflammatory Protein-1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0025147', 'cui_str': 'Medroxyprogesterone'}, {'cui': 'C0858023', 'cui_str': 'Plasma thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}]",38.0,0.0125662,"CONCLUSIONS


Stepper-based ET is feasible in non-ambulatory hemiplegic patients and is effective in improving aerobic fitness.","[{'ForeName': 'Shu-Chun', 'Initials': 'SC', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Chih-Chin', 'Initials': 'CC', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'Tieh-Cheng', 'Initials': 'TC', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Carl P C', 'Initials': 'CPC', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ming-Feng', 'Initials': 'MF', 'LastName': 'Liao', 'Affiliation': 'Department of Neurology, Chang Gung Memorial Hospital, Linkuo, TAIWAN.'}, {'ForeName': 'Chien-Ya', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital, Linkou, TAIWAN.'}, {'ForeName': 'Jong-Shyan', 'Initials': 'JS', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002846']
325,34921215,Correction: Electrocardiogram for heart rate evaluation during preterm resuscitation at birth: a randomized trial.,,2022,,['preterm resuscitation at birth'],['Correction: Electrocardiogram'],[],"[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",[],,0.143302,,"[{'ForeName': 'Natalia V', 'Initials': 'NV', 'LastName': 'Abbey', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Mashruwala', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Weydig', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Steven Brown', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Ramon', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ibrahim', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Imran N', 'Initials': 'IN', 'LastName': 'Mir', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Myra H', 'Initials': 'MH', 'LastName': 'Wyckoff', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Kapadia', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA. vishal.kapadia@utsouthwestern.edu.'}]",Pediatric research,['10.1038/s41390-021-01835-6']
326,34931372,Population pharmacokinetics and enterohepatic recirculation of hyzetimibe and its main metabolite in Chinese healthy subjects.,"AIMS


Hyzetimibe (HS-25), a new drug approved for hypercholesterolaemia, exhibits obvious enterohepatic recirculation (EHC) after oral administration. Up to now, little is known about the kinetics of HS-25. Therefore, we performed this population pharmacokinetic (PopPK) analysis aiming to describe the PK behaviour of HS-25 and its main metabolite (M1), and to identify significant covariates contributing to the variability.
METHODS


The plasma concentration data used for modelling were obtained from an open-label, single-dose, randomized, 2-period crossover bioequivalence study. PopPK modelling was performed with NONMEM 7.4.1 using nonlinear mixed effect modelling approach. Goodness of fit plots, bootstrap and visual predictive check were used for model internal validation. Data from another study were used for external validation.
RESULTS


Data from 16 male and 8 female subjects were used in the PopPK analysis. HS-25 and M1 concentrations in the modelling cohort were well described by a 1-compartment model incorporating first-pass metabolism and a gallbladder compartment, accounting for the EHC process. The release kinetic of gall was mimicked by a first-order constant plus a switch on/off effect. Body weight was identified as a significant covariate effecting on the clearance and apparent distribution volume of HS-25, as well as  k   mg    , the transfer rate from metabolite compartment to gallbladder compartment. Internal and external validation demonstrated an acceptable predictive ability of the final model.
CONCLUSION


We present the first PopPK model describing HS-25 and M1 concentrations simultaneously, with the EHC process considered. The modelling and simulation results could provide reference for the clinical use of HS-25.",2022,"Internal and external validation demonstrated an acceptable predictive ability of the final model.
","['16 male and 8 female subjects', 'Chinese healthy subjects']",[],"['Body weight', 'HS-25 and M1 concentrations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",16.0,0.028301,"Internal and external validation demonstrated an acceptable predictive ability of the final model.
","[{'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Zourong', 'Initials': 'Z', 'LastName': 'Ruan', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Shao', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Lou', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}]",British journal of clinical pharmacology,['10.1111/bcp.15187']
327,34936109,Anterior Palatoplasty With Expansion Sphincter Pharyngoplasty for All Type of Pharyngeal Collapse.,"OBJECTIVES/HYPOTHESIS


This study was aimed to compare the efficiency of the anterior palatoplasty and expansion sphincter pharyngoplasty (APwESP) technique for all patterns of velopharyngeal obstruction (anterior-posterior [APPC], lateral [LPC], or combined circular pharyngeal collapse [CPC]).
STUDY DESIGN


The study was designed as a randomized prospective trial at Kâtip Çelebi University, Atatürk Training, and Research Hospital.
METHODS


Patients only with velopharyngeal obstruction were included. Three groups were created according to the obstruction pattern (APPC, LPC, and CPC) for the study. Outcome parameters included patient's demographics, apnea-hypopnea index (AHI), lowest oxygen saturation (LOS), Stanford subjective scale of snoring (SSSS), and Epworth sleepiness scale (ESS).
RESULTS


Thirty-one (34.1%) patients were in APPC group, while 30 (33.0%) patients were in LPC, and 30 (33.0%) were in CPC group. Preoperatively for all patients, on average, AHI was 33.4 ± 13.6, SSSS was 8.3 ± 1.0, ESS was 16.5 ± 2.6, and LOS was determined as 85.5 ± 3.6. There was a significant postoperative improvement in all parameters for all patients. There was no significant difference in outcome parameters between the groups according to obstruction pattern postoperatively. After APwESP surgery, obstruction pattern was not a significant factor for AHI (P = .234), SSSS (P = .180), and LOS (P = .280) (repeated measure analysis of variance test). The rate of surgical success was detected similarly for both of the study groups (P = .435). The rate of successful surgery for severe obstructive sleep apnea in the APPC group was 72.2%, 88.2% in the LPC group, and 75.0% in the CPC group (P = .472).
CONCLUSION


A combination of APwESP surgery can manage all types of pharyngeal obstruction confidently.
LEVEL OF EVIDENCE


3 Laryngoscope, 132:1313-1319, 2022.",2022,"After APwESP surgery, obstruction pattern was not a significant factor for AHI (P = .234), SSSS (P = .180), and LOS (P = .280) (repeated measure analysis of variance test).","['Patients only with velopharyngeal obstruction were included', 'Kâtip Çelebi University, Atatürk Training, and Research Hospital', 'Thirty-one (34.1']","['anterior palatoplasty and expansion sphincter pharyngoplasty (APwESP) technique', 'LPC', 'APwESP surgery', 'CPC']","['rate of successful surgery for severe obstructive sleep apnea', 'SSSS', 'rate of surgical success', 'obstruction pattern (APPC, LPC, and CPC', ""patient's demographics, apnea-hypopnea index (AHI), lowest oxygen saturation (LOS), Stanford subjective scale of snoring (SSSS), and Epworth sleepiness scale (ESS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0450355', 'cui_str': '31'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}, {'cui': 'C0192234', 'cui_str': 'Repair of pharynx'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0052145', 'cui_str': 'apalcillin'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}]",,0.0231855,"After APwESP surgery, obstruction pattern was not a significant factor for AHI (P = .234), SSSS (P = .180), and LOS (P = .280) (repeated measure analysis of variance test).","[{'ForeName': 'Ejder', 'Initials': 'E', 'LastName': 'Ciğer', 'Affiliation': 'Atatürk Training and Research Hospital, Otolaryngology-Head and Neck Surgery Clinic, Kâtip Çelebi University, Izmir, Turkey.'}, {'ForeName': 'Akif', 'Initials': 'A', 'LastName': 'İşlek', 'Affiliation': 'Otolaryngology-Head & Neck Surgery Clinic, Acibadem Eskişehir Hospital, Eskişehir, Turkey.'}]",The Laryngoscope,['10.1002/lary.29999']
328,34936023,Antenatal pelvic floor muscle training and urinary incontinence: a randomized controlled 7-year follow-up study.,"INTRODUCTION AND HYPOTHESIS


Urinary incontinence is common postpartum. Our aims were to assess whether antenatal exercise including pelvic floor muscle training (PFMT) has long-term effects on urinary incontinence (UI) and to explore factors associated with UI 7 years postpartum.
METHODS


A follow-up of a two-centre randomized controlled trial performed at St. Olavs Hospital and Stavanger University Hospital, Norway. In the original trial women were randomized to a 12-week structured exercise protocol including PFMT or standard antenatal care during pregnancy. Link to an electronic questionnaire was sent by postal mail 7 years postpartum. Prevalence of UI was assessed with Sandvik severity index and compared between groups. Factors associated with UI were studied using multivariable logistic regression analysis.
RESULTS


The response rate was 35% (298/855). UI was reported by 78 (51%) in the intervention group and 63 (57%) in the control group (p = 0.539). In the multivariable logistic regression analyses, women with UI at inclusion had a five-fold increase in odds of UI at 7 years (OR 5.4, 95% CI 2.6, 11.5). Engaging in regular exercise was not significantly associated with UI at 7 years; however, UI was associated with lower exercise intensity (OR 2.4, 95% CI 1.2, 4.6).
CONCLUSIONS


We found no group differences of antenatal exercise including PFMT on UI after 7 years among the responders. UI in pregnancy increased the risk of long-term UI. Regular exercise was not associated with UI at 7 years; however, women with UI were more than twice as likely to exercise at lower intensity than continent women.",2022,UI was reported by 78 (51%) in the intervention group and 63 (57%) in the control group (p = 0.539).,"['St. Olavs Hospital and Stavanger University Hospital, Norway']","['Regular exercise', 'electronic questionnaire', 'structured exercise protocol including PFMT or standard antenatal care during pregnancy', 'Antenatal pelvic floor muscle training', 'antenatal exercise including PFMT', 'antenatal exercise including pelvic floor muscle training (PFMT']","['Sandvik severity index', 'response rate', 'exercise intensity']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0419126', 'cui_str': 'Antenatal exercises'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.0510316,UI was reported by 78 (51%) in the intervention group and 63 (57%) in the control group (p = 0.539).,"[{'ForeName': 'Signe Nilssen', 'Initials': 'SN', 'LastName': 'Stafne', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, P.O. Box 8905, 7491, Trondheim, Norway. signe.n.stafne@ntnu.no.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Dalbye', 'Affiliation': 'Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Oda M', 'Initials': 'OM', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Yvonne E', 'Initials': 'YE', 'LastName': 'Hjelle', 'Affiliation': 'Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Kjell Åsmund', 'Initials': 'KÅ', 'LastName': 'Salvesen', 'Affiliation': 'Department of Obstetrics and Gynecology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Mørkved', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, P.O. Box 8905, 7491, Trondheim, Norway.'}, {'ForeName': 'Hege Hølmo', 'Initials': 'HH', 'LastName': 'Johannessen', 'Affiliation': 'Department of Health and Welfare, Østfold University College, Fredrikstad, Norway.'}]",International urogynecology journal,['10.1007/s00192-021-05028-x']
329,34939824,Effectiveness of Continuous Glucose Monitoring in Older Adults with Type 2 Diabetes Treated with Basal Insulin.,"Objective:  To evaluate the effectiveness and safety of real-time continuous glucose monitoring (CGM) in adults 65 years old and older with type 2 diabetes (T2D) using basal without bolus insulin.  Research Design and Methods:  Using data from the MOBILE randomized trial comparing CGM versus blood glucose meter (BGM) monitoring for T2D treated with basal insulin, the treatment effect in participants ≥65 years (range: 65-79 years,  N  = 42) was compared with the treatment effect in participants <65 years (range: 33-64 years,  N  = 133).  Results:  For participants ≥65 years old, mean change in hemoglobin A1c (HbA1c) was -1.08% in the CGM group and -0.38% in the BGM group (adjusted mean difference = -0.65% [95% confidence interval (CI) -1.49 to 0.19]). In contrast, the adjusted mean difference in HbA1c between treatment groups was -0.35% [95% CI -0.77 to 0.07] in the <65 years age group. For time in range 70-180 mg/dL (TIR), mean adjusted treatment group difference was 19% (95% CI 4 to 35,  P  = 0.01) in ≥65 years old participants and 12% (95% CI 4 to 19,  P  = 0.003) in those <65 years old. Comparable treatment group differences favoring the CGM group were observed in both the ≥65 and <65 years age groups for mean glucose and less time >180, 250, and 300 mg/dL. Hypoglycemia was low in both groups with little difference between treatment groups in both age groups.  Conclusions:  In this study of adults with T2D treated with basal insulin without bolus insulin, participants ≥65 years old using CGM had a greater increase in TIR and a reduction in hyperglycemia than those using BGM and the benefit appeared to be at least as great as that observed in younger adults.",2022,"Comparable treatment group differences favoring the CGM group were observed in both the ≥65 and <65 years age groups for mean glucose and less time >180, 250, and 300 mg/dL. Hypoglycemia was low in both groups with little difference between treatment groups in both age groups.  ","['participants ≥65 years (range: 65-79 years,  N \u2009=\u200942) was compared with the treatment effect in participants <65 years (range: 33-64 years,  N \u2009=\u2009133', 'adults with T2D treated with basal insulin without bolus insulin, participants ≥65 years old using', 'Older Adults with Type 2 Diabetes Treated with Basal Insulin', 'adults 65 years old and older with type 2 diabetes (T2D) using basal without bolus insulin']","['real-time continuous glucose monitoring (CGM', 'CGM versus blood glucose meter (BGM) monitoring for T2D treated with basal insulin', 'CGM', 'Continuous Glucose Monitoring']","['hemoglobin A1c (HbA1c', 'hyperglycemia', 'dL. Hypoglycemia', 'TIR']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}]",,0.127318,"Comparable treatment group differences favoring the CGM group were observed in both the ≥65 and <65 years age groups for mean glucose and less time >180, 250, and 300 mg/dL. Hypoglycemia was low in both groups with little difference between treatment groups in both age groups.  ","[{'ForeName': 'Shichun', 'Initials': 'S', 'LastName': 'Bao', 'Affiliation': 'Department of Medicine, Division of Diabetes, Endocrinology, and Metabolism, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'JAEB Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'JAEB Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'JAEB Center for Health Research, Tampa, Florida, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2021.0494']
330,34932107,Effect of a Multiorgan Focused Clinical Ultrasonography on Length of Stay in Patients Admitted With a Cardiopulmonary Diagnosis: A Randomized Clinical Trial.,"Importance


There are accumulating data about the utility of diagnostic multiorgan focused clinical ultrasonography (FCU) in the assessment of patients admitted with cardiopulmonary symptoms.
Objective


To determine whether adding multiorgan FCU to the initial clinical evaluation of patients admitted with cardiopulmonary symptoms reduces hospital length of stay, hospital readmissions, and in-hospital costs.
Design, Setting, and Participants


This is a prospective, parallel-group, superiority, randomized clinical trial with a 1:1 allocation ratio. The study was conducted at The Royal Melbourne Hospital, a tertiary public hospital located in Melbourne, Victoria, Australia. Adults aged 18 years or older admitted to the internal medicine ward with a cardiopulmonary diagnosis were enrolled between September 2018 and December 2019 and were followed up until hospital discharge. Data analysis was performed from August 2020 to January 2021.
Interventions


The intervention involved an internal medicine physician-performed heart, lung, and 2-point vein compression FCU in addition to standard clinical evaluation.
Main Outcomes and Measures


The primary outcome was the difference in the mean length of hospital stay, defined as the number of hours from admission to the internal medicine ward to hospital discharge. A difference of 24 hours was defined as clinically important. Secondary outcomes included hospital readmissions at 30 days and hospital care costs.
Results


A total of 250 participants were enrolled and 2 were excluded, leaving 248 participants (mean [SD] age, 80.1 [11.0] years; 121 women [48.7%]) in the final analysis. There were 124 patients in the intervention group and 124 patients in the control group. The most common initial diagnoses were acute decompensated heart failure (113 patients [45.5%]), pneumonia (45 patients [18.1%]), and exacerbated chronic pulmonary disease (32 patients [12.9%]). The length of hospital stay was 113.4 hours (95% CI, 91.7-135.1 hours) in the FCU group and 125.3 hours (95% CI, 101.7-148.8 hours) in the control group (P = .53). The 30-day readmission rate was not different between groups (FCU vs control, 20 of 124 patients [16.1%] vs 15 of 124 patients [12.0%]), nor were total in-hospital costs (FCU vs control, A$7831.1 [95% CI, A$5586.1-A$10 076.1] vs A$7895.7 [95% CI, A$6385.9-A$9.405.5]).
Conclusions and Relevance


In this randomized clinical trial, adult patients admitted to an internal medicine ward with a cardiopulmonary diagnosis, who underwent multiorgan FCU of the heart, lungs, and lower extremities veins during their initial clinical assessment, did not have a shorter hospital length of stay by more than 24 hours, compared with patients who received standard care.
Trial Registration


Australian New Zealand Clinical Trials Registry Identifier: ACTRN12618001442291.",2021,"The length of hospital stay was 113.4 hours (95% CI, 91.7-135.1 hours) in the FCU group and 125.3 hours (95% CI, 101.7-148.8 hours) in the control group (P = .53).","['124 patients in the intervention group and 124 patients in the control group', 'patients admitted with cardiopulmonary symptoms reduces hospital length of stay, hospital readmissions, and in-hospital costs', 'A total of 250 participants were enrolled and 2 were excluded, leaving 248 participants (mean [SD] age, 80.1 [11.0] years; 121 women [48.7%]) in the final analysis', 'patients admitted with cardiopulmonary symptoms', 'Patients Admitted With a Cardiopulmonary Diagnosis', 'adult patients admitted to an internal medicine ward with a cardiopulmonary diagnosis, who underwent multiorgan FCU of the heart, lungs, and lower extremities veins during their initial clinical assessment, did not have a shorter hospital length of stay by more than 24 hours, compared with patients who received standard care', 'Adults aged 18 years or older admitted to the internal medicine ward with a cardiopulmonary diagnosis were enrolled between September 2018 and December 2019 and were followed up until hospital discharge', 'Royal Melbourne Hospital, a tertiary public hospital located in Melbourne, Victoria, Australia']","['clinical ultrasonography (FCU', 'FCU', 'Multiorgan Focused Clinical Ultrasonography']","['pneumonia', 'hospital readmissions at 30 days and hospital care costs', 'exacerbated chronic pulmonary disease', '30-day readmission rate', 'Length of Stay', 'length of hospital stay', 'mean length of hospital stay, defined as the number of hours from admission to the internal medicine ward to hospital discharge', 'total in-hospital costs', 'acute decompensated heart failure']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0226813', 'cui_str': 'Structure of vein of lower extremity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",250.0,0.235527,"The length of hospital stay was 113.4 hours (95% CI, 91.7-135.1 hours) in the FCU group and 125.3 hours (95% CI, 101.7-148.8 hours) in the control group (P = .53).","[{'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Cid-Serra', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canty', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Douglas F', 'Initials': 'DF', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine and Community Care, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Maier', 'Affiliation': 'Department of Medicine and Community Care, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Fazio', 'Affiliation': 'Department of Medicine and Community Care, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Doa', 'Initials': 'D', 'LastName': 'El-Ansary', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Colin F', 'Initials': 'CF', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.38228']
331,34929031,A Pragmatic Randomized Comparative Trial of e-Cigarettes and Other Nicotine Products for Quitting or Long-Term Substitution in Smokers.,"INTRODUCTION


Tobacco harm reduction has potential to improve individual and population health. However, little research exists on low-intensity interventions, such as encouraging longer-term NRT or e-cigarette use. We aimed to determine whether: (1) encouraging use of nicotine products as long-term tobacco substitutes is more effective for smoking abstinence than standard treatment, and (2) offering e-cigarettes is more effective than NRT.
METHODS


An open-label, parallel-group randomized trial was conducted in Australia between 2014 and 2015, with 1563 adult daily smokers, randomized to: (A) standard cessation advice and NRT: advice to use NRT short-term, (B) quit or substitute advice and NRT: advice to use NRT as a longer-term substitute for smoking if required to maintain smoking cessation, or (C) Quit or substitute advice and NRT and/or e-cigarettes. Participants were offered an initial supply of products they could then purchase for up to 7 months. The primary outcome was self-reported continuous smoking abstinence at 7 months. Point prevalence, dual use, and cigarette reduction were secondary outcomes.
RESULTS


At 7 months, 2.8% (N = 9) of group A (N = 324) were abstinent, compared with 1.8% (N = 11) in B (N = 620) and 1.3% (N = 8) in C (N = 619) (adjusted odds ratio [ORs]: B vs. A 0.66, 95% confidence interval [CI]: 0.27-1.63; C vs. A 0.46, 95% CI: 0.17-1.21; C vs. B 0.69, 95% CI 0.27-1.73). There were no suspected unexpected serious adverse reactions associated with trial products.
CONCLUSION


A free trial of NRT and first generation e-cigarettes and advice on long-term substitution was no better for smoking abstinence than usual care.
CLINICAL TRIAL REGISTRATION


The trial was registered with the Australian Therapeutic Goods Administration under their Clinical Trials Notification scheme and the Australian and New Zealand Clinical Trials Registry (ACTRN12612001210864).
IMPLICATIONS


This pragmatic trial allowed the comparison of existing and alternative policy options under semi-realistic conditions, such as product choice and financial cost. All trial arms had low rates of smoking cessation. The findings suggest that providing unflavored cigalike e-cigarettes without additional support may not increase quitting compared with advice to use standard NRT in a general population of Australians who smoke. More intensive support and education, and/or opportunity to try a range of e-cigarette products, may be required to motivate quit attempts using e-cigarettes.",2022,"There were no suspected unexpected serious adverse reactions associated with trial products.
","['Australia between 2014 and 2015, with 1563 adult daily smokers, randomised to: A', 'quitting or long-term substitution in smokers']","['nicotine products as long-term tobacco substitutes', 'NRT', 'e-cigarettes and other nicotine products', 'Standard cessation advice and NRT: advice to use NRT short-term B) Quit or substitute advice and NRT: advice to use NRT as a longer-term substitute for smoking if required to maintain smoking cessation or C) Quit or substitute advice and NRT and/or e-cigarettes']","['low rates of smoking cessation', 'Point prevalence, dual use, and cigarette reduction', 'serious adverse reactions', 'self-reported continuous smoking abstinence', 'smoking abstinence']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",324.0,0.0880305,"There were no suspected unexpected serious adverse reactions associated with trial products.
","[{'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Morphett', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Fraser', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Borland', 'Affiliation': 'School of Psychological Sciences, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Hall', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Walker', 'Affiliation': 'School of Population Health, National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'School of Population Health, National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Gartner', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Australia.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab266']
332,34937145,Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients.,"BACKGROUND


Remdesivir improves clinical outcomes in patients hospitalized with moderate-to-severe coronavirus disease 2019 (Covid-19). Whether the use of remdesivir in symptomatic, nonhospitalized patients with Covid-19 who are at high risk for disease progression prevents hospitalization is uncertain.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial involving nonhospitalized patients with Covid-19 who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression (age ≥60 years, obesity, or certain coexisting medical conditions). Patients were randomly assigned to receive intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3) or placebo. The primary efficacy end point was a composite of Covid-19-related hospitalization or death from any cause by day 28. The primary safety end point was any adverse event. A secondary end point was a composite of a Covid-19-related medically attended visit or death from any cause by day 28.
RESULTS


A total of 562 patients who underwent randomization and received at least one dose of remdesivir or placebo were included in the analyses: 279 patients in the remdesivir group and 283 in the placebo group. The mean age was 50 years, 47.9% of the patients were women, and 41.8% were Hispanic or Latinx. The most common coexisting conditions were diabetes mellitus (61.6%), obesity (55.2%), and hypertension (47.7%). Covid-19-related hospitalization or death from any cause occurred in 2 patients (0.7%) in the remdesivir group and in 15 (5.3%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.03 to 0.59; P = 0.008). A total of 4 of 246 patients (1.6%) in the remdesivir group and 21 of 252 (8.3%) in the placebo group had a Covid-19-related medically attended visit by day 28 (hazard ratio, 0.19; 95% CI, 0.07 to 0.56). No patients had died by day 28. Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group.
CONCLUSIONS


Among nonhospitalized patients who were at high risk for Covid-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo. (Funded by Gilead Sciences; PINETREE ClinicalTrials.gov number, NCT04501952; EudraCT number, 2020-003510-12.).",2022,"Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group.
","['562 patients who underwent randomization and received at least one dose of remdesivir or placebo were included in the analyses: 279 patients in the remdesivir group and 283 in the placebo group', 'nonhospitalized patients with Covid-19 who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression (age ≥60 years, obesity, or certain coexisting medical conditions', 'patients hospitalized with moderate-to-severe coronavirus disease 2019 (Covid-19', 'The mean age was 50 years, 47.9% of the patients were women, and 41.8% were Hispanic or Latinx']","['placebo', 'intravenous remdesivir']","['obesity', 'diabetes mellitus', 'composite of a Covid-19-related medically attended visit or death from any cause by day 28', 'adverse event', 'risk of hospitalization or death', 'composite of Covid-19-related hospitalization or death', 'Covid-19-related medically attended visit', 'Adverse events', 'Covid-19-related hospitalization or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",562.0,0.798363,"Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group.
","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Vaca', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Mera', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Webb', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Perez', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Godson', 'Initials': 'G', 'LastName': 'Oguchi', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ryan', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Bibi U', 'Initials': 'BU', 'LastName': 'Nielsen', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Ausberto', 'Initials': 'A', 'LastName': 'Hidalgo', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Yessica', 'Initials': 'Y', 'LastName': 'Sachdeva', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Shilpi', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Olayemi', 'Initials': 'O', 'LastName': 'Osiyemi', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Skarbinski', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Juneja', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Hyland', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Camus', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Mazin', 'Initials': 'M', 'LastName': 'Abdelghany', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Davies', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Behenna-Renton', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Duff', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Morgan J', 'Initials': 'MJ', 'LastName': 'Katz', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Schiffer', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Hill', 'Affiliation': ""From Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Care United Research, Forney (S.M.) - all in Texas; the Nuren Medical and Research Center, Miami (C.E.V.), Evolution Clinical Trials, Hialeah Gardens (G.P.), the Midland Florida Clinical Research Center, DeLand (G.O.), Luminous Clinical Research-South Florida Urgent Care, Pembroke Pines (A.H.), and Triple O Research Institute Professional Association, West Palm Beach (O.O.) - all in Florida; Hospital Universitari Germans Trias i Pujol and IrsiCaixa AIDS Research Institute, Barcelona (R.P.), and Hospital Universitario Infanta Leonor and Gregorio Marañón Health Research Institute, Madrid (P.R.) - all in Spain; the Cherokee Nation Outpatient Health Center, Tahlequah, OK (J.M.); Intermountain Healthcare (B.J.W., S.M.B.) and the University of Utah School of Medicine (S.M.B.) - both in Murray; Copenhagen University Hospital-Rigshospitalet, Copenhagen (B.U.N.); University College London Hospitals NHS Foundation Trust and the London School of Hygiene and Tropical Medicine - both in London (M.B.); the Institute of Liver Health, Mesa, AZ (Y.S.); Kaiser Permanente, Oakland (J.S.), and Gilead Sciences, Foster City (K.J., R.H.H., A.O., S.C., G.C., M.A., S.D., N.B.-R., F.D.) - both in California; Brigham and Women's Hospital and Harvard Medical School - both in Boston (F.M.M.); Johns Hopkins University School of Medicine, Baltimore (M.J.K.); the University of Colorado School of Medicine, Aurora (A.A.G.); and the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine - both in Seattle (J.T.S., J.A.H.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2116846']
333,34958366,Dronedarone vs. placebo in patients with atrial fibrillation or atrial flutter across a range of renal function: a post hoc analysis of the ATHENA trial.,"AIMS


Use of antiarrhythmic drugs (AADs) in patients with chronic kidney disease (CKD) is challenging owing to issues with renal clearance, drug accumulation, and increased proarrhythmic risks. Because CKD is a common comorbidity in patients with atrial fibrillation/atrial flutter (AF/AFL), it is important to establish the efficacy and safety of AAD treatment in patients with CKD.
METHODS AND RESULTS


Dronedarone efficacy and safety in individuals with AF/AFL and varying renal functionality [estimated glomerular filtration rate (eGFR): ≥60, ≥45 and <60, and <45 mL/min] was investigated in a post hoc analysis of ATHENA (NCT00174785), a randomized, double-blind trial of dronedarone vs. placebo in patients with paroxysmal or persistent AF/AFL plus additional cardiovascular (CV) risk factors. Log-rank testing and Cox regression were used to compare the incidence of endpoints between treatments. Overall, 4588 participants were enrolled from the trial. There was no interaction between treatment group and baseline eGFR assessed as a continuous variable (P = 0.743) for the first CV hospitalization or death from any cause (primary outcome). This outcome was lower with dronedarone vs. placebo across a wide range of renal function. First CV hospitalization and first AF/AFL recurrence were both lower in the two least renally impaired subgroups with dronedarone vs. placebo. Treatment emergent adverse events leading to treatment discontinuation were more frequent with dronedarone vs. placebo and occurred more often in patients with severe renal impairment.
CONCLUSION


Dronedarone is an effective AAD in patients with AF/AFL and CV risk factors across a wide range of renal function.",2022,"Treatment emergent adverse events leading to treatment discontinuation were more frequent with dronedarone versus placebo and occurred more often in patients with severe renal impairment.
","['patients with atrial fibrillation or atrial flutter across a range of renal function', 'patients with CKD', 'patients with AF/AFL and CV risk factors', 'patients with chronic kidney disease (CKD', 'patients with paroxysmal or persistent AF/AFL plus additional cardiovascular (CV) risk factors', 'patients with severe renal impairment', '4588 participants were enrolled from the trial', 'patients with atrial fibrillation/atrial flutter (AF/AFL', 'individuals with AF/AFL and varying renal functionality (estimated glomerular filtration rate [eGFR]: ≥60, ≥45 and <60, and <45 mL/min']","['placebo', 'dronedarone', 'antiarrhythmic drugs (AADs', 'dronedarone versus placebo', 'Dronedarone']",['First CV hospitalization and first AF/AFL recurrence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",4588.0,0.136162,"Treatment emergent adverse events leading to treatment discontinuation were more frequent with dronedarone versus placebo and occurred more often in patients with severe renal impairment.
","[{'ForeName': 'Mate', 'Initials': 'M', 'LastName': 'Vamos', 'Affiliation': 'Cardiac Electrophysiology Division, Department of Internal Medicine, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gi-Byoung', 'Initials': 'GB', 'LastName': 'Nam', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Calkins', 'Affiliation': 'Division of Cardiology, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Fuwai Hospital, CAMS & PUMC, Beijing, China.'}, {'ForeName': 'Kwo-Chang', 'Initials': 'KC', 'LastName': 'Ueng', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chung-Shan Medical University Hospital, Taichung City, Taiwan.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ludwigs', 'Affiliation': 'Sanofi, Stockholm, Sweden.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Wieloch', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Laval, Quebec, Canada.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Cardiology, J.W. Goethe University, Frankfurt, Germany.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvab090']
334,34910859,Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.,"BACKGROUND


NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b-3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America.
METHODS


We conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reverse-transcriptase-polymerase-chain-reaction-confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed.
RESULTS


Of the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted - 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P<0.001). Ten moderate and 4 severe cases occurred, all in placebo recipients, yielding vaccine efficacy against moderate-to-severe disease of 100% (95% CI, 87.0 to 100). Most sequenced viral genomes (48 of 61, 79%) were variants of concern or interest - largely B.1.1.7 (alpha) (31 of the 35 genomes for variants of concern, 89%). Vaccine efficacy against any variant of concern or interest was 92.6% (95% CI, 83.6 to 96.7). Reactogenicity was mostly mild to moderate and transient but was more frequent among NVX-CoV2373 recipients than among placebo recipients and was more frequent after the second dose than after the first dose.
CONCLUSIONS


NVX-CoV2373 was safe and effective for the prevention of Covid-19. Most breakthrough cases were caused by contemporary variant strains. (Funded by Novavax and others; PREVENT-19 ClinicalTrials.gov number, NCT04611802.).",2022,"Most sequenced viral genomes (48 of 61, 79%) were variants of concern or interest - largely B.1.1.7 (alpha) (31 of the 35 genomes for variants of concern, 89%).","['29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received', 'Adults in the United States and Mexico', 'adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection']","['placebo', 'NVX-CoV2373', 'vaccine and 9868 placebo', 'NVX-CoV2373 or placebo']","['vaccine efficacy against reverse-transcriptase-polymerase-chain-reaction-confirmed Covid-19', 'Vaccine efficacy', 'Vaccine efficacy against moderate-to-severe disease', 'Reactogenicity', 'vaccine efficacy against moderate-to-severe disease', 'Efficacy and Safety']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",29949.0,0.608454,"Most sequenced viral genomes (48 of 61, 79%) were variants of concern or interest - largely B.1.1.7 (alpha) (31 of the 35 genomes for variants of concern, 89%).","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Dunkle', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Kotloff', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gay', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Áñez', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Adelglass', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Alejandro Q', 'Initials': 'AQ', 'LastName': 'Barrat Hernández', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Wayne L', 'Initials': 'WL', 'LastName': 'Harper', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Duncanson', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'McArthur', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Diana F', 'Initials': 'DF', 'LastName': 'Florescu', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'McClelland', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Garcia-Fragoso', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Riesenberg', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Musante', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Fried', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Safirstein', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McKenzie', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Jeanfreau', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Jeffrey K', 'Initials': 'JK', 'LastName': 'Kingsley', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Henderson', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Dakotah C', 'Initials': 'DC', 'LastName': 'Lane', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruíz-Palacios', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Coombs', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Alex L', 'Initials': 'AL', 'LastName': 'Greninger', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Ake', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Woo', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Glenn', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Dubovsky', 'Affiliation': 'From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2116185']
335,34953166,Influencing Perceptions of Harm of Waterpipe Tobacco Smoking Among One Member of Couples Who Use Waterpipe.,"INTRODUCTION


Waterpipe tobacco smoking (WTS) often occurs socially, increasing health risks for the smoker and others through secondhand smoke effects. While messages on WTS harms enhance perceived risks for self, whether these messages elevate perceived risks for others, such as one's romantic partner who engages in WTS, is unclear. We tested this idea by surveying one member of dual-smoking couples who engages in WTS.
AIMS AND METHODS


As part of an online study, we enrolled adults ages 18-30 who engaged in WTS and were in a committed relationship of at least 6 months whose partner engaged in WTS. Participants were randomized to a control arm or to one of two arms consisting of watching a brief video on health harms or overcoming myths about WTS, respectively. Outcomes were perceived harms and measures of desire and probability of quitting for self and partner.
RESULTS


Participants (N = 238) who watched either video, compared with participants who did not watch a video, reported greater perceived health risks for self and partner and that their own WTS harmed their partner. Participants who watched either video reported a greater desire to quit for themselves, perceived that their partner had a greater desire to quit, and reported a higher likelihood of quitting together in the next 6 months.
CONCLUSIONS


Brief videos containing risk-based messaging increase young adult waterpipe tobacco smokers' perceived harms and desire to quit for self and partner. This can be a useful strategy to motivate cessation in couples who engage in WTS.
IMPLICATIONS


This study shows for the first time that at least among one member of dual-smoking couples who engages in WTS, brief videos on harms of WTS influences perceived harms and motivation to quit for the self and one's partner. This can be a useful strategy to promote cessation.",2022,"Participants were randomized to a control arm or to one of two arms consisting of watching a brief video on health harms or overcoming myths about WTS, respectively.","['surveying one member of dual-smoking couples who engages in WTS', 'one member of couples who use waterpipe', 'couples who engage in WTS', 'enrolled adults ages 18-30 who engaged in WTS and were in a committed relationship of at least six months whose partner engaged in WTS', 'young adult waterpipe tobacco smokers']","['Waterpipe tobacco smoking (WTS', 'watching a brief video on health harms or overcoming myths about WTS', 'Brief videos containing risk-based messaging increase']","['health risks', 'harms and measures of desire and probability of quitting for self and partner']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4505131', 'cui_str': 'Waterpipe Tobacco'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C4505131', 'cui_str': 'Waterpipe Tobacco'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]",238.0,0.0832113,"Participants were randomized to a control arm or to one of two arms consisting of watching a brief video on health harms or overcoming myths about WTS, respectively.","[{'ForeName': 'Isaac M', 'Initials': 'IM', 'LastName': 'Lipkus', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Sanders', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Center for Tobacco Research, Ohio State University Comprehensive Cancer Center, Department of Internal Medicine, Ohio State University College of Medicine, Columbus, OH, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab261']
336,34961729,Evaluating Auricular Point Acupressure for Chronic Low Back Pain Self-Management Using Technology: A Feasibility Study.,"BACKGROUND


Chronic low back pain, one of the most common reasons for seeking healthcare services, causes significant negative impacts on individuals and society. Nonpharmacologic therapies and self-management are included in practice guidelines, but their implementation is challenging.
AIM


To assess the feasibility of using an auricular point acupressure (APA) mobile app as a self-guided tool to learn and self-administer APA to manage chronic low back pain (cLBP) and to compare cLBP outcomes between 2 groups (app vs app + telehealth).
DESIGN


A 2-phase study design was used. In phase 1, participants (app group, n = 18) had in-person study visits and installed the app to learn and self-administer APA to manage cLBP. In phase 2, all research activities occurred remotely due to the COVID-19 pandemic, so a second group was recruited (app + telehealth, n = 19). The app + telehealth group underwent a virtual session, installed the app, and were provided the opportunity for questions and verification on the accuracy of the self-administered APA.
SETTING


The participants were recruited by distributing study flyers at outpatient clinics and referrals.
PARTICIPANTS


Participants with chronic low back pain were eliglbe for the study.
METHODS


Using a quasi-experimental design with a mixed methods approach, all participants were instructed to download the APA app, provided an APA kit (includes seeds embedded within pre-cut squares of adhesive tape), and advised to self-administer APA with guidance from the app for 4 weeks to manage their cLBP. Study outcomes were collected at the preintervention time point as well as postintervention and 1-month follow-up. Interviews were also conducted at the postintervention time point.
RESULTS


Of the 37 participants enrolled, six dropped out, and the attrition rate was 16%. Adherence to APA practice was high (85%-94%). After 4 weeks of APA treatment, participants in the app + telehealth group experienced a 29% decrease in pain intensity during the postintervention time point and a 35% reduction during the 1-month follow-up. Similar improvements were noted in pain interference (28%) and physical function (39%) for participants in the app + telehealth group at the 1-month follow-up. These changes are slightly higher compared with those in the app group (21% pain intensity reduction, 23% improved pain interferences, and 26% improved physical function) during the 1-month follow-up. Overall, APA was found to be feasible using the app and the qualitative findings showed acceptability of the intervention in both groups.
CONCLUSIONS


It is feasible to learn and self-administer APA with an app, supplemented with either in-person or telehealth sessions, presenting a promising intervention toward cLBP self-management. Telehealth was found to boost this intervention effectively.",2022,Similar improvements were noted in pain interference (28%) and physical function (39%) for participants in the app + telehealth group at the 1-month follow-up.,"['The participants were recruited by distributing study flyers at outpatient clinics and referrals', 'Participants with chronic low back pain were eliglbe for the study']","['auricular point acupressure (APA) mobile app', 'APA', 'Auricular Point Acupressure']","['physical function', 'pain interference', 'attrition rate', 'pain interferences', 'pain intensity']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",37.0,0.0703867,Similar improvements were noted in pain interference (28%) and physical function (39%) for participants in the app + telehealth group at the 1-month follow-up.,"[{'ForeName': 'Chao Hsing', 'Initials': 'CH', 'LastName': 'Yeh', 'Affiliation': 'University of Texas Health Science Center (UTHealth), Cizik School of Nursing, Houston, Texas. Electronic address: chao.hsing.yeh@uth.tmc.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kawi', 'Affiliation': 'University of Nevada, Las Vegas, School of Nursing, Los Vegas, Nevada.'}, {'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Ni', 'Affiliation': 'University of Texas Health Science Center (UTHealth), Cizik School of Nursing, Houston, Texas.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Christo', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2021.11.007']
337,34962151,Magnitude of Glycemic Improvement in Patients with Type 2 Diabetes Treated with Basal Insulin: Subgroup Analyses from the MOBILE Study.,"Objective:  To determine if type 2 diabetes patients using basal insulin without prandial insulin with worse glycemic control at baseline would have the greatest benefit from using real-time continuous glucose monitoring (CGM).  Methods:  We conducted a post hoc analysis of the MOBILE Study, a multicenter trial examining the impact of CGM versus self-monitoring with a blood glucose meter (BGM) in patients with type 2 diabetes treated with basal insulin without prandial insulin. Participants were divided into subgroups based on baseline hemoglobin A1c (HbA1c) and baseline time-in-range 70-180 mg/dL (TIR). Change in TIR from baseline was calculated within each subgroup.  Results:  In subgroups based on baseline HbA1c, compared with the BGM group, the CGM group had 14% greater increase in TIR for participants with baseline HbA1c ≥8.5%, 14% greater increase for baseline HbA1c ≥9.0%, 22% greater increase for baseline HbA1c ≥9.5%, and 32% greater increase for baseline HbA1c ≥10.0% ( P -value for interaction = 0.27). The time spent with glucose >250 mg/dL was significantly lower with CGM compared with BGM among participants with higher HbA1c values ( P  for interaction = 0.004). Results in subgroups based on baseline TIR paralleled the results in subgroups based on baseline HbA1c.  Conclusion:  While the benefit of CGM on TIR among patients with type 2 diabetes treated with basal insulin is apparent across the range of baseline glycemic control, the greatest impact of CGM is in those with the worst baseline glycemic control, particularly among those with HbA1c ≥10%. Clinical Trial Registration number: NCT03566693.",2022,dL was significantly lower with CGM compared with BGM among participants with higher HbA1c values (p for interaction = 0.004).,"['type 2 diabetes patients using', 'patients with type 2 diabetes treated with basal insulin without prandial insulin', 'Patients with Type 2 Diabetes Treated with']","['BGM', 'CGM versus self-monitoring with a blood glucose meter (BGM', 'CGM', 'basal insulin without prandial insulin', 'Basal Insulin']","['Glycemic Improvement', 'TIR']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]",,0.234824,dL was significantly lower with CGM compared with BGM among participants with higher HbA1c values (p for interaction = 0.004).,"[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Endocrinology, Metabolism, and Lipids, Atlanta, GA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Dexcom, Inc., San Diego, California, USA.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2021.0489']
338,34962679,Is It Safe to Reuse Healing Abutments? An Experimental Study on IL-1β and TNF-α Cytokine Levels in Peri-Implant Crevicular Fluid.,"PURPOSE


To compare pro-inflammatory cytokine levels in the peri-implant crevicular fluid (PICF) in unused and reused healing abutments.
MATERIALS AND METHODS


This study was a controlled randomized, double-blind clinical trial. Seventy-two patients who met the inclusion criteria were divided into two groups. After one-stage implant placement, in group A, an unused healing abutment, and in group B, a reused healing abutment, was connected to the implant fixture. After 2 months, clinical measurements for keratinized gingiva (KG), plaque index (PI), and bleeding index (BI) (Ainamo and Bay) were taken, and PICF sampling was performed to evaluate pro-inflammatory IL-1β and TNF-α cytokine levels using the ELISA test. Comparison of clinical measurements and cytokine levels between the two study groups was made using the Mann-Whitney test.
RESULT


Clinical measurements and sampling were performed on 60 patients (nA = 27, nB = 33). There was no significant difference between the two groups in clinical measurements (BI (p = 0.96) and PI (p = 0.06)) or TNF-α (p = 0.63), and IL-1β (p = 0.26) cytokine levels.
CONCLUSION


Reused healing abutments that are cleaned and sterilized properly do not appear to induce further peri-implant pro-inflammatory response; therefore, they can be utilized temporarily until implant abutment insertion.",2022,"There was no significant difference between the two groups in clinical measurements (BI (p-value=0.96) and PI (p-value=0.06)) or TNF-α (p-value=0.63) and IL-1β (p-value=0.26) cytokine levels.
","['Peri-Implant Crevicular Fluid', 'Seventy-two patients who met the inclusion criteria', '60 patients (nA = 27, nB = 33']",[],"['pro-inflammatory IL-1β and TNF-α cytokine levels', 'IL-1β and TNF-α Cytokine Levels', 'clinical measurements for keratinized gingiva (KG), plaque index (PI), and bleeding index (BI) (Ainamo and Bay', 'cytokine levels']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",[],"[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3203003', 'cui_str': 'Bays'}]",72.0,0.105598,"There was no significant difference between the two groups in clinical measurements (BI (p-value=0.96) and PI (p-value=0.06)) or TNF-α (p-value=0.63) and IL-1β (p-value=0.26) cytokine levels.
","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Lashkarizadeh', 'Affiliation': 'Oral and Dental Diseases Research Center and Department of Periodontics, Kerman Dental School, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Foroudisefat', 'Affiliation': 'Oral and Dental Diseases Research Center and Department of Periodontics, Kerman Dental School, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Abyari', 'Affiliation': 'Oral and Dental Diseases Research Center and Department of Periodontics, Kerman Dental School, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Oral and Dental Diseases Research Center and Department of Periodontics, Kerman Dental School, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Lashkarizadeh', 'Affiliation': 'Oral and Dental Diseases Research Center and Department of Periodontics, Kerman Dental School, Kerman University of Medical Sciences, Kerman, Iran.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13474']
339,34962457,The effect of vitamin D supplementation on tobacco-related disorders in individuals with a tobacco use disorder: a randomized clinical trial.,"Vitamin D deficiency in cigarette smokers (CS) might associate with several complications, including metabolic deficits, depression and anxiety. This study evaluated the effects of vitamin D on mental health symptoms, nicotine misuse, and biomarkers of metabolic diseases in individuals with a tobacco use disorder. A randomized, double-blind, placebo-controlled trial was conducted with 60 CS subjects receiving either 50,000 IU vitamin D supplements ( n  = 30) or placebo ( n  = 30) every 2 weeks for 24-weeks. Nicotine misuse, mental health scale, and metabolic parameters were measured before and after the intervention in the CS subjects. Compared with the placebo-group, after the 24-weeks intervention, serum 25 (OH) vitamin D levels increased in the intervention group (β 2.96; 95% CI, 0.91, 5.01;  P  = 0.006). In addition, vitamin D supplementation significantly improved Beck Depression Inventory (BDI) (β -2.06; 95% CI, -3.84, -0.28;  P  = 0.02). In addition, vitamin D administration significantly decreased fasting plasma glucose (FPG) (β -4.56; 95% CI, -8.94, -0.19;  P  = 0.04), insulin (β -0.50; 95% CI, -0.88, -0.13;  P  = 0.009), and homeostasis model of assessment-estimated insulin resistance (HOMA-IR) levels (β -0.21; 95% CI, -0.33, -0.08;  P  = 0.001). Furthermore, vitamin D resulted in a significant elevation in total antioxidant capacity (TAC) (β 81.20; 95% CI, 18.30, 144.11;  P  = 0.01), and plasma glutathione (GSH) levels (β 73.05; 95% CI, 18.56, 127.54;  P  = 0.01), compared with the placebo-group. Administration of vitamin D for 24-weeks to CS subjects had beneficial effects on symptoms of depression and several metabolic biomarkers. While this preliminary study suggests that vitamin D might have beneficial effects, its clinical efficacy in individuals with a tobacco use disorder should be further validated in future clinical trials.",2022,"Furthermore, vitamin D resulted in a significant elevation in total antioxidant capacity (TAC) (β 81.20; 95% CI, 18.30, 144.11;  P  = 0.01), and plasma glutathione (GSH) levels (β 73.05; 95% CI, 18.56, 127.54;  P  = 0.01), compared with the placebo-group.","['60 CS subjects receiving either 50,000', 'individuals with a tobacco use disorder', 'cigarette smokers (CS']","['vitamin D', 'placebo', 'IU vitamin D supplements', 'Vitamin D deficiency', 'vitamin D supplementation']","['tobacco-related disorders', 'symptoms of depression and several metabolic biomarkers', 'Nicotine misuse, mental health scale, and metabolic parameters', 'homeostasis model of assessment-estimated insulin resistance (HOMA-IR) levels', 'mental health symptoms, nicotine misuse, and biomarkers of metabolic diseases', 'total antioxidant capacity (TAC', 'Beck Depression Inventory (BDI', 'plasma glutathione (GSH) levels', 'serum 25 (OH) vitamin D levels', 'fasting plasma glucose (FPG']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040336', 'cui_str': 'Tobacco abuse'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",60.0,0.665802,"Furthermore, vitamin D resulted in a significant elevation in total antioxidant capacity (TAC) (β 81.20; 95% CI, 18.30, 144.11;  P  = 0.01), and plasma glutathione (GSH) levels (β 73.05; 95% CI, 18.56, 127.54;  P  = 0.01), compared with the placebo-group.","[{'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Bagheri', 'Affiliation': 'Student Research Committee, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Saghazade', 'Affiliation': 'Student Research Committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Abbaszadeh-Mashkani', 'Affiliation': 'Student Research Committee, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Physiology Research Center, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fatemeh Sadat', 'Initials': 'FS', 'LastName': 'Ghoreishi', 'Affiliation': 'Department of Addiction Studies, School of Medicine AND Clinical Research Development Unit, Matini/Kargarnejad Hospital, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Mesdaghinia', 'Affiliation': 'Physiology Research Center, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Addiction Studies, School of Medicine AND Clinical Research Development Unit, Matini/Kargarnejad Hospital, Kashan University of Medical Sciences, Kashan, Iran.'}]",Journal of addictive diseases,['10.1080/10550887.2021.2010971']
340,34969263,One-Shot Dilatation  vs  Metal Dilator During Percutaneous Nephrolithotomy in Flank-Free Supine Position: A Randomized Controlled Study.,"Background:  The creation and dilatation of the nephrostomy tract is a fundamental step in percutaneous nephrolithotomy (PCNL). In one-shot dilatation (OSD), we used a single Amplatz dilator over a central Alken rod. PCNL in the supine position is as effective and safe as in the prone position. The Barts flank-free modified supine position sums several advantages of the different supine positions. We evaluated the efficacy and safety of OSD compared with metal telescopic dilator (MTD) during PCNL while the patient was in Barts flank-free modified supine position.  Materials and Methods:  Within 2.5 years, 150 patients with kidney stone candidates for PCNL were randomized into two equal groups according to the dilatation technique. In the OSD group, dilatation was performed using a single Amplatz dilator (30F) and in the MTD group dilatation was performed by sequential MTD (9-30F). All PCNL procedures were done with patients in Barts flank-free modified supine position. Patient characteristics, operative data, and results were collected for statistical analysis.  Results:  There are no statistically significant differences between both groups regarding patients' characters. The tracts were effectively dilated in all patients. Statistical analyses show a significant difference ( p  ˂ 0.05) between both groups regarding the time of dilatation (seconds; 68 ± 15  vs  147 ± 18), time of X-ray exposure (seconds; during dilatation; 36 ± 10  vs  61 ± 15 and the total; 157 ± 16  vs  181 ± 20), hemoglobin loss (mg/dL; 0.7 ± 0.2  vs  1.2 ± 0.3), and hospital stay (days; 3 ± 0.6  vs  3.7 ± 0.7) with favorable results to OSD. Complication rates were comparable between the two groups.  Conclusions:  OSD is efficient as MTD during PCNL while patients are in Barts flank-free modified supine position, with less dilatation time, X-ray exposure, blood loss, and hospital stay than MTD.",2022,"Statistical analyses show a significant difference (p ˂0.05) between both groups regarding the time of dilatation (sec) (68 ±15 Vs 147 ±18), time of X-ray exposure (sec) (during dilatation; 36 ±10 Vs 61 ±15 and the total; 157 ±16 Vs 181 ±20), hemoglobin loss (mg/dl) (0.7 ±0.2 Vs 1.2 ±0.3) and hospital stay (day) (3 ±0.6 Vs 3.7 ±0.7) with favorable results to OSD.","['Flank-free supine position', '150 patients with kidney stones candidates for PCNL']","['OSD', 'percutaneous nephrolithotomy', 'metal telescopic dilatation (MTD', 'PCNL', 'metal dilator']","['hemoglobin loss', 'time of X-ray exposure', 'time of dilatation (sec', 'hospital stay', 'dilatation time, X-ray exposure, blood loss, and hospital stay', 'Complication rates']","[{'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0180431', 'cui_str': 'Dilator'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0264398,"Statistical analyses show a significant difference (p ˂0.05) between both groups regarding the time of dilatation (sec) (68 ±15 Vs 147 ±18), time of X-ray exposure (sec) (during dilatation; 36 ±10 Vs 61 ±15 and the total; 157 ±16 Vs 181 ±20), hemoglobin loss (mg/dl) (0.7 ±0.2 Vs 1.2 ±0.3) and hospital stay (day) (3 ±0.6 Vs 3.7 ±0.7) with favorable results to OSD.","[{'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mohyelden', 'Affiliation': 'Urology Department, Faculty of Medicine, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Abdel-Rassoul', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Dogha', 'Affiliation': 'Urology Department, Faculty of Medicine, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Kadry', 'Affiliation': 'Urology Department, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Amro', 'Initials': 'A', 'LastName': 'Mostafa', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of endourology,['10.1089/end.2021.0378']
341,34967801,Physiological Adaptations to High-Intensity Interval Training Combined with Blood Flow Restriction in Masters Road Cyclists.,"PURPOSE


High-intensity interval training (HIIT) and blood flow restriction (BFR) training have been used to enhance athletic performance and cardiovascular health. Combining these training modalities might be an effective training modality for masters athletes who seek to enhance athletic performance and to reduce cardiovascular risks.
METHODS


Fifty masters road cyclists age 35-49 yr were randomly assigned to the continuous exercise training (n = 16), continuous plus HIIT (n = 17), and continuous plus BFR training combined with HIIT (BFRIT; n = 17) for 12 wk. Both HIIT and BFRIT were performed on a cycle ergometer twice a week.
RESULTS


Maximal oxygen consumption (V̇O2max) increased in the HIIT and BFRIT groups (P < 0.05). This was accompanied by significant improvements in maximal cardiac output and stroke volume (P < 0.05). Forty-kilometer time trial performance improved in all three groups (P < 0.05). Peak power output increased in both HIIT and BFRIT groups (P < 0.05). Flow-mediated dilation in both brachial and popliteal arteries increased in all three groups (all P < 0.05). There were no significant changes in carotid intima-media thickness and arterial stiffness in any of the groups. Total lean mass, muscle cross-sectional area and thickness in rectus femoris and vastus lateralis, and peak torque of isokinetic knee extension increased only in the BFRIT group (all P < 0.05). Tissue saturation index decreased only in the BFRIT group (P < 0.05). Changes in 40-km time trial performance were associated with corresponding changes in V̇O2max (r = -0.312, P = 0.029) and peak isokinetic extensor torque (r = -0.432, P = 0.002).
CONCLUSIONS


Including HIIT particularly with BFR in the routine continuous training may be more effective in enhancing performance and physiological functions in masters road cyclists.",2022,"RESULTS


Maximal oxygen consumption (VO2max) increased in the HIIT and BFRIT groups (p < 0.05).","['Masters Road Cyclists', 'Fifty masters road cyclists aged 35-49 years']","['High-intensity interval training (HIIT) and blood flow restriction (BFR) training', 'High-Intensity Interval Training Combined with Blood Flow Restriction', 'continuous exercise training (CON; n = 16), continuous plus high-intensity interval training (HIIT; n = 17), and continuous plus blood flow restriction (BFR) training combined with high-intensity interval training']","['Flow-mediated dilation in both brachial and popliteal arteries', 'Peak power output', 'Maximal oxygen consumption (VO2max', '40 km time trial performance', 'carotid intima-media thickness and arterial stiffness', 'peak isokinetic extensor torque', 'VO2max', 'Tissue saturation index', 'Total lean mass, muscle cross-sectional area and thickness in rectus femoris and vastus lateralis, and peak torque of isokinetic knee extension', 'maximal cardiac output and stroke volume']","[{'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]",,0.0134597,"RESULTS


Maximal oxygen consumption (VO2max) increased in the HIIT and BFRIT groups (p < 0.05).","[{'ForeName': 'Patcharin', 'Initials': 'P', 'LastName': 'Tangchaisuriya', 'Affiliation': 'Faculty of Sports Science, Chulalongkorn University, Bangkok, THAILAND.'}, {'ForeName': 'Napasakorn', 'Initials': 'N', 'LastName': 'Chuensiri', 'Affiliation': 'Faculty of Sports Science, Chulalongkorn University, Bangkok, THAILAND.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Daroonwan', 'Initials': 'D', 'LastName': 'Suksom', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002857']
342,34974502,Acute Citrulline Blunts Aortic Systolic Pressure during Exercise and Sympathoactivation in Hypertensive Postmenopausal Women.,"PURPOSE


Hypertensive postmenopausal women (PMW) have exaggerated exercise systolic blood pressure (SBP) due to impaired functional sympatholysis. l-Citrulline (CIT) supplementation attenuates aortic SBP responses to cold pressor test (CPT)-induced vasoconstriction in young men. We hypothesized that acute CIT ingestion would attenuate aortic SBP and leg hemodynamic responses during exercise and CPT (EX + CPT).
METHODS


Fifteen hypertensive PMW (61 ± 7 yr) were randomly assigned to consume either 6 g of CIT or placebo (PL) separated by a minimum 3-d washout phase. Brachial and aortic blood pressure, femoral artery blood flow (FBF), and vascular conductance (FVC) were measured at rest and during 5 min of unilateral plantarflexion exercise with a CPT applied during minutes 4 and 5.
RESULTS


No differences between conditions were found in FBF, FVC, and brachial and aortic blood pressure at rest and during exercise alone. Changes in brachial SBP (CIT vs PL, 29 ± 12 vs 40 ± 10 mm Hg) and mean arterial pressure (CIT vs PL, 21 ± 10 vs 33 ± 11 mm Hg), and aortic SBP (CIT vs PL, 27 ± 11 vs 38 ± 9 mm Hg) and mean arterial pressure (CIT vs PL, 23 ± 9 vs 33 ± 11 mm Hg) to EX + CPT were lower in the CIT versus PL condition (P < 0.05). FBF, FVC, and functional sympatholysis (%ΔFVC) were not significantly different between conditions.
CONCLUSIONS


Acute CIT ingestion attenuated aortic SBP response to exercise and cold-induced sympathetic activation that may prevent left ventricle overload in hypertensive PMW.",2022,"No differences between conditions were found in FBF, FVC, brachial and aortic BP at rest and during exercise alone.","['Hypertensive Postmenopausal Women', 'Fifteen hypertensive PMW (61 ± 7 years', 'Hypertensive postmenopausal women (PMW', 'young men']","['L-Citrulline (CIT) supplementation', 'cold pressor test (CPT', 'acute CIT ingestion', 'Acute Citrulline Blunts Aortic Systolic Pressure during Exercise and Sympathoactivation', 'unilateral plantarflexion exercise with a CPT', 'CIT or placebo (PL']","['Brachial and aortic BP, femoral artery blood flow (FBF), and vascular conductance (FVC', 'brachial SBP', 'aortic SBP response', 'aortic SBP', 'exercise systolic blood pressure (BP', 'aortic SBP and leg hemodynamic responses', 'FBF, FVC, brachial and aortic BP', 'mean arterial pressure (MAP', 'aortic systolic BP (SBP) responses', 'FBF, FVC, and functional sympatholysis (%ΔFVC']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2609163', 'cui_str': 'Sympatholysis'}]",,0.0666966,"No differences between conditions were found in FBF, FVC, brachial and aortic BP at rest and during exercise alone.","[{'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Maharaj', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Dillon', 'Affiliation': ''}, {'ForeName': 'Yejin', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Mauricio A', 'Initials': 'MA', 'LastName': 'Martinez', 'Affiliation': ''}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002848']
343,34974493,A Prospective Trial to Access the Optimal Circumference of Resection in Antireflux Mucosectomy for Treatment-refractory GERD.,"OBJECTIVE


There is still no gold standard regarding the optimal circumference of antireflux mucosectomy (ARMS) in patients with treatment-refractory gastroesophageal reflux disease (GERD). The aim of this study is to assess the safety and effectiveness of resection procedures when the circumferences are different.
PATIENTS AND METHODS


Thirty-two patients with treatment-refractory GERD were allocated into group A (16 cases) and group B (16 cases) by randomization. In group A and group B, a 2/3 and 1/2 circumference, 1.5 cm wide mucosal resection of the gastric cardia was performed. Health-related quality of life (HRQOL), frequency scale for the symptoms of GERD (FSSG), DeMeester scores and acid exposure time (AET) were accessed at baseline and at 24 months after treatment. Physical component summaries (PCS), mental component summaries (MCS), and RE-specific summary (RES) scores were calculated.
RESULTS


All patients had successful surgical procedures and no bleeding, perforation, or dysphagia occurred. The PCS, MCS, and RES scores of post-ARMS were higher than those of pre-ARMS in groups A and B, and the FSSG, DeMeester scores and AET decreased after ARMS in both groups, with differences that were statistically significant (P<0.05). The changes in PCS, MCS, RES, FSSG, DeMeester scores, and AET were greater in group A than in group B, with significant differences in PCS, MCS, RES, and FSSG scores (P<0.05), but no significant differences in, DeMeester scores and AET (P>0.05).
CONCLUSION


ARMS is an effective treatment for treatment-refractory GERD. Moreover, we recommend the 2/3 circumference, 1.5 cm wide mucosal resection of the gastric cardia.",2022,"The PCS, MCS, and RES scores of post-ARMS were higher than those of pre-ARMS in groups A and B, and the FSSG, DeMeester scores and AET decreased after ARMS in both groups, with differences that were statistically significant (P<0.05).","['patients with treatment-refractory gastroesophageal reflux disease (GERD', 'Thirty-two patients with treatment-refractory GERD']","['ARMS', 'antireflux mucosectomy (ARMS']","['changes in PCS, MCS, RES, FSSG, DeMeester scores, and AET', 'safety and effectiveness', 'Health-related quality of life (HRQOL), frequency scale for the symptoms of GERD (FSSG), DeMeester scores and acid exposure time (AET', 'successful surgical procedures and no bleeding, perforation, or dysphagia', 'Physical component summaries (PCS), mental component summaries (MCS), and RE-specific summary (RES) scores', 'PCS, MCS, RES, and FSSG scores', 'PCS, MCS, and RES scores of post-ARMS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0450357', 'cui_str': '32'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",32.0,0.0255016,"The PCS, MCS, and RES scores of post-ARMS were higher than those of pre-ARMS in groups A and B, and the FSSG, DeMeester scores and AET decreased after ARMS in both groups, with differences that were statistically significant (P<0.05).","[{'ForeName': 'Shiyu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Suqian, Suqian, Jiangsu, China.""}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi.'}, {'ForeName': 'Huiying', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Tang', 'Affiliation': ""The First People's Hospital of Suqian, Suqian, Jiangsu, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': ""The First People's Hospital of Suqian, Suqian, Jiangsu, China.""}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001650']
344,34969608,Clinical evaluation of the effect of Zataria multiflora Boiss and Trachyspermum copticum (L.) on the patients with irritable bowel syndrome.,"BACKGROUND AND AIM


Irritable Bowel Syndrome (IBS) is the most common gastrointestinal dysfunction characterized by abdominal pain or discomfort, as well as changes in bowel movements and stool shape. Given the global trend towards the increased use of complementary and alternative medicine (CAM), the high prevalence of IBS, the lack of a standard treatment for all IBS subtypes, and patients' willingness to use CAM treatments, investigations into CAM treatments are needed. Accordingly, the present study aimed to investigate the effect of a mix of two herbal medicines (Zataria-Trachyspermum, ZT) on the clinical symptoms of patients with IBS.
EXPERIMENTAL PROCEDURE


The present study was performed on 3 groups including the positive control, experimental, and placebo groups. The sample size was calculated as 150 participants. Fifty patients were assigned to one of three parallel groups (ZT capsule, placebo, and mebeverine capsule) by block randomization. All three groups were treated for 4 weeks. The patients were monitored in the follow-up stage for 2 additional weeks.
RESULTS


After the fourth week of intervention, symptoms of pain, bloating, and reflux showed a significant decrease in the ZT group compared to the placebo and mebeverine groups (P <0.05). Moreover, the participants in the ZT group reported a significant decrease in fatigue compared to the other two groups (P <0.05).
CONCLUSION


This study confirmed the positive effect of ZT on IBS symptoms, especially pain, bloating, constipation, and bowel movements.",2022,"This study confirmed the positive effect of ZT on IBS symptoms, especially pain, bloating, constipation, and bowel movements.","['patients with irritable bowel syndrome', 'patients with IBS.\nEXPERIMENTAL PROCEDURE', 'Fifty patients']","['placebo', 'herbal medicines (Zataria-Trachyspermum, ZT', 'complementary and alternative medicine (CAM', 'Zataria multiflora Boiss and Trachyspermum copticum (L', 'ZT', 'parallel groups (ZT capsule, placebo, and mebeverine capsule']","['fatigue', 'symptoms of pain, bloating, and reflux', 'IBS symptoms, especially pain, bloating, constipation, and bowel movements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0065832', 'cui_str': 'mebeverine'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",50.0,0.0692963,"This study confirmed the positive effect of ZT on IBS symptoms, especially pain, bloating, constipation, and bowel movements.","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Jamalizadeh', 'Affiliation': 'Gastroenterology and Hepatology Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran; Department of Persian Medicine, School of Traditional Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Ahmadi', 'Affiliation': 'Gastroenterology and Hepatology Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Shariffar', 'Affiliation': 'Herbal and Traditional Medicine Research Center, Department of Pharmacogenosy, Faculty of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Herbal and Traditional Medicine Research Center, Department of Pharmacogenosy, Faculty of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Setayesh', 'Affiliation': 'Gastroenterology and Hepatology Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran; Department of Persian Medicine, School of Traditional Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Armita', 'Initials': 'A', 'LastName': 'Shahesmaeili', 'Affiliation': 'HIV/STI Surveillance Research Center, and WHO Collaborating center for HIV surveillance,Institute for Futures Studies in Health,Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Haleh', 'Initials': 'H', 'LastName': 'Tajadini', 'Affiliation': 'Gastroenterology and Hepatology Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran; Department of Persian Medicine, School of Traditional Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.12.004']
345,34969526,Training in soft tissue resection using real-time visual computer navigation feedback from the Surgery Tutor: A randomized controlled trial.,"BACKGROUND


In competency-based medical education, surgery trainees are often required to learn procedural skills in a simulated setting before proceeding to the clinical environment. The Surgery Tutor computer navigation platform allows for real-time proctor-less assessment of open soft tissue resection skills; however, the use of this platform as an aid in acquisition of procedural skills is yet to be explored.
METHODS


In this prospective randomized controlled trial, 20 final year medical students were randomized to receive either training with real-time computer navigation feedback (Intervention, n = 10) or simulation training without navigation feedback (Control, n = 10) during resection of simulated non-palpable soft tissue tumors. Real-time computer navigation feedback allowed participants to visualize the position of their scalpel relative to the tumor. Computer navigation feedback was removed for postintervention assessment. Primary outcome was positive margin rate. Secondary outcomes were procedure time, mass of tissue excised, number of scalpel motions, and distance traveled by the scalpel.
RESULTS


Training with real-time computer navigation resulted in a significantly lower positive margin rate as compared to training without navigation feedback (0% vs 40%, P = .025). All other performance metrics were not significantly different between the 2 groups. Participants in the intervention group displayed significant improvement in positive margin rate from baseline to final assessment (80% vs 0%, P < .01), whereas participants in the Control group did not.
CONCLUSION


Real-time visual computer navigation feedback from the Surgery Tutor resulted in superior acquisition of procedural skills as compared to training without navigation feedback.",2022,"RESULTS


Training with real-time computer navigation resulted in a significantly lower positive margin rate as compared to training without navigation feedback (0% vs 40%, P = .025).",['20 final year medical students'],"['training with real-time computer navigation feedback (Intervention, n\xa0= 10) or simulation training without navigation feedback (Control, n\xa0= 10) during resection of simulated non-palpable soft tissue tumors', 'Training in soft tissue resection using real-time visual computer navigation feedback']","['procedure time, mass of tissue excised, number of scalpel motions, and distance traveled by the scalpel', 'positive margin rate']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}, {'cui': 'C0037579', 'cui_str': 'Neoplasm of soft tissue'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}]",,0.028956,"RESULTS


Training with real-time computer navigation resulted in a significantly lower positive margin rate as compared to training without navigation feedback (0% vs 40%, P = .025).","[{'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Poole', 'Affiliation': ""Kingston Health Sciences Center, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Ungi', 'Affiliation': ""Kingston Health Sciences Center, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Fichtinger', 'Affiliation': ""Kingston Health Sciences Center, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Zevin', 'Affiliation': ""Kingston Health Sciences Center, Queen's University, Kingston, Ontario, Canada. Electronic address: bz15@queensu.ca.""}]",Surgery,['10.1016/j.surg.2021.11.037']
346,34931202,Randomized controlled trial transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection.,"BACKGROUND


The efficacy of SARS-CoV-2 convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. We hypothesized that CCP might prevent infection when administered before symptoms or laboratory evidence of infection.
METHODS


This double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed COVID-19 in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was development of SARS-CoV-2 infection.
RESULTS


180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for SARS-CoV-2 RT-PCR positivity at screening. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection; 6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. There were 28 adverse events in CCP and 58 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs. 25.2 days; p=0.49) and COVID-19 (26.3 vs. 25.9 days; p=0.35) were similar for both groups.
CONCLUSION


In this trial, which enrolled persons with recent exposure to a person with confirmed COVID-19, high titer CCP as post-exposure prophylaxis appeared safe, but did not prevent SARS-CoV-2 infection.
TRIAL REGISTRATION


Clinicaltrial.gov number NCT04323800 .",2021,"Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs. 25.2 days; p=0.49) and COVID-19 (26.3 vs. 25.9 days; p=0.35) were similar for both groups.
","['180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021', 'Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed COVID-19 in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible']","['prophylactic high titer (≥1:320) CCP with standard plasma', 'SARS-CoV-2 convalescent plasma (CCP', 'CCP']","['development of SARS-CoV-2 infection', 'efficacy and safety', 'COVID-19-related hospitalizations', 'mean infection free time (RMIFT', 'SARS-CoV-2 infection', 'SARS-CoV-2 RT-PCR positivity']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}]",180.0,0.431276,"Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs. 25.2 days; p=0.49) and COVID-19 (26.3 vs. 25.9 days; p=0.35) were similar for both groups.
","[{'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Shoham', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Casadevall', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hanley', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gebo', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cachay', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Seble G', 'Initials': 'SG', 'LastName': 'Kassaye', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Paxton', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Levine', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Currier', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Allen', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Anjan', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Appel', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Sheriza', 'Initials': 'S', 'LastName': 'Baksh', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Blair', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Broderick', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Caputo', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Cluzet', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Marie Elena', 'Initials': 'ME', 'LastName': 'Cordisco', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cruser', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Forthal', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Yuriko', 'Initials': 'Y', 'LastName': 'Fukuta', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Gawad', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gniadek', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hammel', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Moises A', 'Initials': 'MA', 'LastName': 'Huaman', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jedlicka', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Karlen', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Sabra', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lane', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Nichol', 'Initials': 'N', 'LastName': 'McBee', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Meisenberg', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Merlo', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Mosnaim', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Han-Sol', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pekosz', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Petrini', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rausch', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shade', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Janna R', 'Initials': 'JR', 'LastName': 'Shapiro', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'J Robinson', 'Initials': 'JR', 'LastName': 'Singleton', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sutcliffe', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Thomas', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Yarava', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zand', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Zenilman', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'Aaron A R', 'Initials': 'AAR', 'LastName': 'Tobian', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sullivan', 'Affiliation': 'Department of Medicine (S.S., K.G., D.T., P.B., J.Z., A.B., L.A., C.M.) Department of Pathology (E.B., A.T.), Department of Neurology (K.L., N.M., D.H., A.G., A.Y.) and the Department of Ophthalmology (DJ), The Johns Hopkins University School of Medicine, Baltimore, MD, Departments of Molecular Microbiology and Immunology (A.C., D.S., S.K., H.S.P., C.A.C., J.R.S., A.P. A.J.) and Epidemiology (B.L., D.S., D.J., S.E.,S.B., C.S.) The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Mosaic Consulting Ltd., Israel (N.K.), Department of Medicine, Luminis Health, Annapolis, MD (B.M.), Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX (Y.F), Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, RI (A.L.), Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC (S.K.), Division of Allergy and Immunology, Department of Medicine (G.M.), and Department of Pathology (T.G.), Northshore University Health System, Evanston, IL, Department of Medicine, Division of Infectious Diseases University of Cincinnati, Cincinnati, OH (M.H.), Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, CA (D.F.), Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, CA (J.S.), Department of Medicine, Division of Infectious Diseases (E.C.) and Department of Pathology (E.A.), University of California, San Diego, San Diego, CA, Department of Medicine, Division of Hematology and Oncology, University of Massachusetts, Worchester, MA (J.G.), Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL (SA), Department of Medicine, University of Rochester, Rochester, NY (MZ), Department of Neurology, University of Utah, Salt Lake City, UT (J.R.S), Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, TX (B.P.), Department of Emergency Medicine Wayne State University, Detroit, MI (J.P.), Danbury Hospital (P.B.), Norwalk Hospital (J.H.), Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, NY (VC) and University of Vermont (J.P., W.R., M.E.C.), Nuvance Health, Danbury, CT, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health Baltimore, MD (O.L.).'}]",medRxiv : the preprint server for health sciences,['10.1101/2021.12.13.21267611']
347,34985236,"End-range Maitland mobilization decreasing pain sensitivity in knee osteoarthritis: randomized, controlled clinical trial.","BACKGROUND


Pressure pain threshold (PPT) is a widely applied method for measuring the magnitude of increased peripheral and central pain sensitivity causing hyperalgesia in knee osteoarthritis (OA). Although manual therapy techniques effects positively PPT, the effect of end-range Maitland mobilization has not been evaluated in knee OA.
AIM


The aim of this study was to investigate the effect of end-range Maitland mobilization compared to sham manual therapy technique on PPT and function-related measures.
DESIGN


The design of the study was of a randomized, controlled clinical trial.
SETTING


Outpatient setting.
POPULATION


Forty women with moderate-to-severe knee OA.
METHODS


Twenty patients (N.=20) were randomly assigned to Maitland group (MG) and twenty patients (N.=20) to control group (CG). Patients in MG received single end-range Maitland mobilization while patients in CG received sham manual therapy technique. Assessment was performed at baseline, 30 minutes and after 1-week period. Outcome measures were PPT locally at knee and distant at ipsilateral extensor carpi radialis longus muscle, general pain during the previous week using the Visual Analogue Scale (VAS), Timed Up and Go Test (TUG) time associated with pain measured with Numerating Pain Rating Scale (NPRS) and strength of passive resistance of knee at onset of pain.
RESULTS


Despite all outcome measures improved significantly postintervention, no changes were detected after 1-week period compared to postintervention in MG. No change of outcome measures was found also postintervention and after 1-week period compared to postintervention in CG. All postintervention results showed significant improvement in between-group comparison in favor of MG. However, after 1-week period, only strength of passive resistance revealed significant difference in between-group comparison in favor of MG (P<0.001).
CONCLUSIONS


Although end-range Maitland mobilization has an immediate effect on decreasing peripheral and central pain sensitivity and improving function-related measures in knee OA, these changes may not cause clinically relevant effect based on data measured after 1-week period.
CLINICAL REHABILITATION IMPACT


Investigating the time-course of end-range Maitland mobilization for determining the optimal treatment frequency during rehabilitation is suggested in knee OA.",2022,"Despite all outcome measures improved significantly postintervention, no changes were detected after 1-week period compared to postintervention in MG.","['knee osteoarthritis', 'knee osteoarthritis (OA', 'Twenty patients (n=20', 'Forty women with moderate-to-severe knee OA', 'Outpatient setting']","['Maitland Group (MG', 'Control Group (CG', 'CG received sham manual therapy technique', 'End-range Maitland mobilization']","['peripheral and central pain sensitivity', 'strength of passive resistance', 'PPT locally at knee and distant at ipsilateral Extensor Carpi Radialis Longus muscle, general pain during the previous week using the Visual Analogue Scale (VAS), Timed Up and Go Test (TUG) time associated with pain measured with Numerating Pain Rating Scale (NPRS) and strength of passive resistance of knee at onset of pain', 'PPT and function-related measures', 'pain sensitivity']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0234243', 'cui_str': 'Central pain'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",40.0,0.0487245,"Despite all outcome measures improved significantly postintervention, no changes were detected after 1-week period compared to postintervention in MG.","[{'ForeName': 'Miklós', 'Initials': 'M', 'LastName': 'Pozsgai', 'Affiliation': 'Department of Balneology, Harkány Termal Rehabilitation Center, Harkány, Hungary - miklos.pozsgay@gmail.com.'}, {'ForeName': 'Iván A', 'Initials': 'IA', 'LastName': 'Péter', 'Affiliation': 'Department of Balneology, Harkány Termal Rehabilitation Center, Harkány, Hungary.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Farkas', 'Affiliation': 'Medical School, Institute of Bioanalysis, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Than', 'Affiliation': 'Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Nóra', 'Initials': 'N', 'LastName': 'Nusser', 'Affiliation': 'Department of Balneology, Harkány Termal Rehabilitation Center, Harkány, Hungary.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.22.06680-1']
348,34981547,Pharmacokinetics and food impact assessment of ademetionine enteric-coated tablet as an endogenous substance drug in healthy Chinese volunteers.,"WHAT IS KNOWN AND OBJECTIVES


Ademetionine 1,4-Butanedisulfonate (SAMe) enteric-coated tablets are widely used for treatment of pre-cirrhotic and cirrhotic intrahepatic cholestasis, as well as intrahepatic cholestasis of pregnancy (ICP), but incomplete clinical data and interference from endogenous substances pose numerous challenges for clinical trial of ademetionine. The objective of this study was to evaluate the pharmacokinetic profile of SAMe enteric-coated tablets and to assess its food impact and safety in healthy Chinese subjects.
METHODS


A randomized, open-label, single-dose study was carried out to determine the pharmacokinetics of SAMe enteric-coated tablets administered in both fasted and postprandial conditions. Baseline collection and data adjustment were required to reduce the effect of endogenous substances. Relevant pharmacokinetic data from subjects administered the reference formulation will be disclosed and utilized in this thesis.
RESULTS


Twenty-four subjects with a body mass index (BMI) of 19-24 kg/m 2  were enrolled in the study and all completed the trial. The impact of food on the drug was noticeable, with faster absorption in the fasting group (T max  , 4.50 ± 1.07 and 7.50 ± 1.58 for the fasting and postprandial groups, respectively) but higher exposure in the postprandial group (AUC 0-inf  , 4021.02 ± 3377.13 and 5087.28 ± 3539.26 for the fasting and postprandial groups, respectively). No serious adverse effects were observed in the fasted and postprandial conditions.
WHAT IS NEW AND CONCLUSIONS


The pharmacokinetic profile of SAMe enteric-coated tablets in healthy Chinese subjects was partially complemented in this study. SAMe enteric-coated tablets showed promising safety in fasted and postprandial conditions. However, the impact of food on the drug was significant and might access to the absorption site and affect biochemical reactions.",2022,"No serious adverse effects were observed in the fasted and postprandial conditions.
","['healthy Chinese subjects', 'Twenty-four subjects with a body mass index (BMI) of 19-24\xa0kg/m 2  were enrolled in the study and all completed the trial', 'healthy Chinese volunteers']",['ademetionine enteric-coated tablet'],"['faster absorption', 'serious adverse effects']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0039226', 'cui_str': 'Gastro-resistant oral tablet'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",24.0,0.0850798,"No serious adverse effects were observed in the fasted and postprandial conditions.
","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems, Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Hanbing', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems, Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Hangzhou Yiyuan Pharmaceutical Technology Co. Ltd., Hangzhou, China.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems, Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems, Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Hangzhou Yiyuan Pharmaceutical Technology Co. Ltd., Hangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Jin', 'Affiliation': 'Hangzhou Yiyuan Pharmaceutical Technology Co. Ltd., Hangzhou, China.'}, {'ForeName': 'Keqiang', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Hangzhou Yiyuan Pharmaceutical Technology Co. Ltd., Hangzhou, China.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13601']
349,34859852,Effect of Vitamin D supplementation in patients with liver cirrhosis having spontaneous bacterial peritonitis: a randomized controlled study.,"OBJECTIVE


Spontaneous Bacterial Peritonitis (SBP) is one of the most serious liver cirrhosis with ascites complications. Vitamin D (Vit D) deficiency has been associated with a high risk of infection and mortality in cirrhotic patients. Herein, the assessment of Vit D level as a prognostic marker in SBP patients and the impact of Vit D supplementation on their treatment plan was studied as well.
PATIENTS AND METHODS


Ascetic patients with SBP and Vit D deficiency were divided randomly into treatment and control groups. The control group received standard treatment without Vit D and the treatment group received standard treatment plus Vit D. Clinical monitoring of Vit D was done over 6 months.
RESULTS


At baseline, all patients in both groups revealed an elevated serum and ascetic TLC, AST, ALT, total and direct bilirubin, in addition to elevation in INR and procalcitonin (PCT) level. Univariate regression analysis confirmed that deficiency of Vit D was an independent predictor of infection and mortality (p < 0.01; Crude Hazard Ratio: 0.951). Over 6 months, the study revealed significant improvement in serum Vit D level in the treatment group (34.6 ± 9.2 and 18.3 ± 10.0 ng/mL; p < 0.001). Moreover, a statistically significant increase in survival rate (64% vs. 42%; p < 0.05) and duration (199.5 days vs. 185.5 days; p < 0.05) were recorded as well. Univariate and multivariate regression analysis confirmed that Vit D supplementation was positively correlated to survival over 6 months (p < 0.001; Adjusted Hazard Ratio: 0.895).
CONCLUSIONS


Vit D deficiency is prevalent in SBP cirrhotic patients and is used as an independent predictor of infection and death. Therefore, Vit D supplementation revealed improvement in their response to treatment.",2021,"Moreover, a statistically significant increase in survival rate (64% vs. 42%; p < 0.05) and duration (199.5 days vs. 185.5 days; p < 0.05) were recorded as well.","['SBP patients', 'Ascetic patients with SBP and Vit D deficiency', 'SBP cirrhotic patients', 'patients with liver cirrhosis having spontaneous bacterial peritonitis', 'cirrhotic patients']","['Vitamin D (Vit D) deficiency', 'Vit D supplementation', 'Vitamin D supplementation', 'standard treatment without Vit D and the treatment group received standard treatment plus Vit D. Clinical monitoring of Vit D']","['survival', 'elevated serum and ascetic TLC, AST, ALT, total and direct bilirubin, in addition to elevation in INR and procalcitonin (PCT) level', 'serum Vit D level', 'survival rate', 'infection and mortality']","[{'cui': 'C0275551', 'cui_str': 'Primary bacterial peritonitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0800714,"Moreover, a statistically significant increase in survival rate (64% vs. 42%; p < 0.05) and duration (199.5 days vs. 185.5 days; p < 0.05) were recorded as well.","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Biochemistry, Molecular Biology and Biochemistry Department, National Hepatology and Tropical Medicine Research Institute, Egypt. akarmalawy@horus.edu.eg.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Al-Karmalawy', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'El-Kholy', 'Affiliation': ''}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'El-Damas', 'Affiliation': ''}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Abostate', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Mostafa', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hamada', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Khalik Elkady', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hassan', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Al-Hussain', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Khalil', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Badawy', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Elebeedy', 'Affiliation': ''}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Alsfouk', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Shaheenl', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202111_27239']
350,34980572,Preoperative photography improves patient satisfaction following hallux valgus surgery.,"BACKGROUND


Patient satisfaction is variable following hallux valgus (HV) surgery. This prospective, blinded, randomized trial endeavored to determine whether showing patients a preoperative photograph would improve satisfaction following HV corrective surgery.
METHODS


Adult patients undergoing HV surgery were randomized to a picture group (P) or a no picture group (NP). P-group patients were shown their preoperative photograph for 5 min at each postoperative visit. Outcome measures included the Foot Function Index (FFI), the Foot Ankle Outcome Score (FAOS), and a patient satisfaction questionnaire.
RESULTS


Twenty-nine patients were enrolled in the study (15P, 14 NP). At 3, and 6 months postoperatively, patients in the P-group were more likely to be completely satisfied with the appearance of their foot. There were no differences between groups with respect to postoperative HVA, IMA, or FFI, and FAOS scores.
CONCLUSION


Patient satisfaction is increased following hallux valgus corrective surgery by reminding patients of the preoperative appearance of their foot through the use of photographs.
LEVEL OF EVIDENCE


Level I, randomized control trial.",2022,"There were no differences between groups with respect to postoperative HVA, IMA, or FFI, and FAOS scores.
","['Adult patients undergoing HV surgery', 'Twenty-nine patients were enrolled in the study (15P, 14 NP']","['picture group (P) or a no picture group (NP', 'Preoperative photography']","['Patient satisfaction', 'Foot Function Index (FFI), the Foot Ankle Outcome Score (FAOS), and a patient satisfaction questionnaire', 'patient satisfaction', 'postoperative HVA, IMA, or FFI, and FAOS scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0031749', 'cui_str': 'Photography'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0178681', 'cui_str': 'Homovanillate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",29.0,0.15393,"There were no differences between groups with respect to postoperative HVA, IMA, or FFI, and FAOS scores.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Del Balso', 'Affiliation': 'Western University, London Health Sciences Centre - Victoria Hospital, Department of Surgery, Division of Orthopaedic Surgery, London, Ontario, Canada. Electronic address: christopher.delbalso@lhsc.on.ca.'}, {'ForeName': 'Michel A', 'Initials': 'MA', 'LastName': 'Taylor', 'Affiliation': 'Hughston Clinic Tennessee, Nashville, Tennessee, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ching', 'Affiliation': 'Western University, London Health Sciences Centre - Victoria Hospital, Department of Surgery, Division of Orthopaedic Surgery, London, Ontario, Canada.'}, {'ForeName': 'Abdel Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'Western University, London Health Sciences Centre - Victoria Hospital, Department of Surgery, Division of Orthopaedic Surgery, London, Ontario, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Sanders', 'Affiliation': 'Western University, London Health Sciences Centre - Victoria Hospital, Department of Surgery, Division of Orthopaedic Surgery, London, Ontario, Canada.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2021.12.011']
351,34988975,Topical treatment of actinic keratoses in organ transplant recipients: a feasibility study for SPOT (Squamous cell carcinoma Prevention in Organ transplant recipients using Topical treatments).,"BACKGROUND


The risk of cutaneous squamous cell carcinoma (cSCC) is significantly increased in organ transplant recipients (OTRs). Clearance of actinic keratoses (AKs) is generally regarded as a surrogate biomarker for cSCC prevention. OTR-cSCC chemoprevention with topical AK treatments has not been investigated in randomized controlled trials (RCTs), although there is evidence that 5% 5-fluorouracil (5-FU) may be chemoprotective in immunocompetent patients.
OBJECTIVES


To assess the feasibility, activity and evaluation outcomes relevant to the design of a future phase III RCT of topical cSCC chemoprevention in OTRs.
METHODS


OTRs with 10 or more AKs in predefined areas were randomized 1 : 1 : 1 to topical 5-FU, 5% imiquimod (IMIQ) or sunscreen (sun-protective factor 30+) in a phase II, open-label RCT over 15 months. Feasibility outcomes included proportions of eligible OTRs randomized, completing treatment and willing to be re-treated. AK activity [AK clearance, new AK development, patient-centred outcomes (toxicity, health-related quality of life, HRQoL)] and evaluation methodology (clinical vs. photographic) were assessed.
RESULTS


Forty OTRs with 903 AKs were randomized. All feasibility outcomes were met (56% of eligible OTRs were randomized; 89% completed treatment; 81% were willing to be re-treated). AK activity analyses found 5-FU and IMIQ were superior to sunscreen for AK clearance and prevention of new AKs. 5-FU was more effective than IMIQ in AK clearance and prevention in exploratory analyses. Although toxicity was greater with 5-FU, HRQoL outcomes were similar.
CONCLUSIONS


Trials of topical AK treatments in OTRs for cSCC chemoprevention are feasible and AK activity results support further investigation of 5-FU-based treatments in future phase III trials.",2022,AK activity analyses found 5-FU and IMIQ were superior to sunscreen for AK clearance and prevention of new AKs.,"['actinic keratoses in organ transplant recipients', 'organ transplant recipients (OTRs', 'Forty OTRs with 903 AKs were recruited', 'OTRs with 10 or more AKs in predefined areas', 'immunocompetent patients', 'Organ transplant recipients using Topical treatments']","['topical 5-FU, 5%-imiquimod (IMIQ) or sunscreen (SPF 30', '5-FU', '5-fluorouracil (5-FU']","['AK activity (AK clearance, new AK development, patient-centred outcomes (toxicity, health-related quality of life [HRQoL]) and evaluation methodology (clinical versus photographic', 'Clearance of actinic keratoses (AK', 'toxicity']","[{'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3215191', 'cui_str': 'Fluorouracil-containing product in cutaneous dose form'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0812425', 'cui_str': 'Mitotic index'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0015194', 'cui_str': 'Evaluation Methodology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",903.0,0.0520582,AK activity analyses found 5-FU and IMIQ were superior to sunscreen for AK clearance and prevention of new AKs.,"[{'ForeName': 'Zeeshaan-Ul', 'Initials': 'ZU', 'LastName': 'Hasan', 'Affiliation': 'Department of Dermatology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Ikhlaaq', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rubeta N', 'Initials': 'RN', 'LastName': 'Matin', 'Affiliation': 'Department of Dermatology, Churchill Hospital, Oxford University Hospital NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Homer', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Lear', 'Affiliation': 'Department of Dermatology, Salford Royal NHS Foundation Trust, Salford, UK and Manchester Academic Science Centre, Manchester University, UK.'}, {'ForeName': 'Ferina', 'Initials': 'F', 'LastName': 'Ismail', 'Affiliation': 'Royal Free Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Whitmarsh', 'Affiliation': 'Institute of Astronomy, University of Cambridge, Madingley Road, Cambridge, UK.'}, {'ForeName': 'Adele C', 'Initials': 'AC', 'LastName': 'Green', 'Affiliation': 'Cancer Research UK, University of Manchester, Manchester, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thomson', 'Affiliation': 'Department of Dermatology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Milligan', 'Affiliation': 'Royal Free Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hogan', 'Affiliation': 'Department of Dermatology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Van-de-Velde', 'Affiliation': 'Department of Dermatology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Mitchell-Worsford', 'Affiliation': 'Department of Dermatology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kentley', 'Affiliation': 'Department of Dermatology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Gaunt', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Jefferson-Hulme', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Bowden', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Piers', 'Initials': 'P', 'LastName': 'Gaunt', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Proby', 'Affiliation': 'Jacqui Wood Cancer Centre, University of Dundee.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Harwood', 'Affiliation': 'Department of Dermatology, Barts Health NHS Trust, London, UK.'}]",The British journal of dermatology,['10.1111/bjd.20974']
352,34397104,Efficacy of Povidone-Iodine Nasal Irrigation Solution After Sinonasal Surgery: A Randomized Controlled Study.,"OBJECTIVES/HYPOTHESIS


To evaluate the efficacy of postoperative nasal irrigation with povidone-iodine (PVP-I) solution in patients undergoing sinonasal surgery.
STUDY DESIGN


Single-blind, randomized controlled study.
METHODS


This is a prospective, single-blind, randomized controlled study. Patients with chronic rhinosinusitis (CRS) and hypertrophic inferior turbinates who underwent endoscopic sinus surgery (ESS) and inferior turbinate reduction were enrolled in the study. Patients were evaluated using the Taiwanese version of the 22-item Sino-Nasal Outcome Test (TWSNOT-22), rhinomanometry, endoscopic examination, and bacterial cultures. One week after the operation, patients were randomly assigned to either a 0.1% PVP-I nasal irrigation group or a control (normal saline) irrigation group. We then compared the two groups' results to illustrate the effects of nasal irrigation with PVP-I solution following sinonasal surgery.
RESULTS


Of the 55 patients that completed the study, 27 patients were in the PVP-I group and 28 were in the control group. In both groups, the TWSNOT-22 scores, Lund-Kennedy endoscopic scores, and total nasal resistance (TNR) all revealed significant improvements at 3 months postoperatively compared with preoperative measurements (all, P < .05). However, there were no significant differences between the two groups in TWSNOT-22, endoscopic, or TNR scores 3 months after the operation (all, P > .05).
CONCLUSIONS


A dilute 0.1% PVP-I nasal irrigation as a postoperative care modality after sinonasal surgery did not provide additional benefit compared with normal saline irrigation.
LEVEL OF EVIDENCE


2 Laryngoscope, 132:1148-1152, 2022.",2022,"However, there were no significant differences between the two groups in TWSNOT-22, endoscopic, or TNR scores 3 months after the operation (all, P > .05).
","['55 patients that completed the study', 'patients undergoing sinonasal surgery', 'Patients with chronic rhinosinusitis (CRS) and hypertrophic inferior turbinates who underwent endoscopic sinus surgery (ESS) and inferior turbinate reduction were enrolled in the study', '27 patients were in the PVP-I group and 28 were in the control group']","['postoperative nasal irrigation with povidone-iodine (PVP-I) solution', 'nasal irrigation with PVP-I solution', 'PVP-I nasal irrigation group or a control (normal saline) irrigation group', 'Povidone-Iodine Nasal Irrigation Solution']","['TWSNOT-22 scores, Lund-Kennedy endoscopic scores, and total nasal resistance (TNR', 'Taiwanese version of the 22-item Sino-Nasal Outcome Test (TWSNOT-22), rhinomanometry, endoscopic examination, and bacterial cultures', 'TWSNOT-22, endoscopic, or TNR scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0430615', 'cui_str': 'Rhinomanometry'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture'}]",27.0,0.037318,"However, there were no significant differences between the two groups in TWSNOT-22, endoscopic, or TNR scores 3 months after the operation (all, P > .05).
","[{'ForeName': 'Po-Hsuan', 'Initials': 'PH', 'LastName': 'Wu', 'Affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ping-Chia', 'Initials': 'PC', 'LastName': 'Cheng', 'Affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Chang', 'Affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wu-Chia', 'Initials': 'WC', 'LastName': 'Lo', 'Affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Po-Wen', 'Initials': 'PW', 'LastName': 'Cheng', 'Affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.'}]",The Laryngoscope,['10.1002/lary.29818']
353,35064733,Behavioural intervention in medication overuse headache: A concealed double-blind randomized controlled trial.,"BACKGROUND AND PURPOSE


Medication overuse headache is a prevalent disorder, with a strong biobehavioural component. Hence, behavioural interventions might effectuate reduction of the overused medication. We assessed in a double-blind manner the efficacy of a behavioural intervention during medication withdrawal therapy.
METHODS


In this concealed, double-blind, randomized controlled trial in medication overuse headache, conducted at the Leiden University Medical Centre, we compared the effect of maximal versus minimal behavioural intervention by a headache nurse during withdrawal therapy. Maximal intervention consisted of an intensive contact schedule, comprising education, motivational interviewing, and value-based activity planning during 12 weeks of withdrawal therapy. Minimal intervention consisted of a short contact only. Patients were unaware of the existence of these treatment arms, as the trial was concealed in another trial investigating botulinum toxin A. Endpoints were successful withdrawal and monthly days of acute medication use after the withdrawal period.
RESULTS


We enrolled 179 patients (90 maximal, 89 minimal intervention). At Week 12, most patients achieved withdrawal in both groups (82/90 [93%] maximal intervention vs. 75/89 [86%] minimal intervention, odds ratio = 2.44, 95% confidence interval [CI] = 0.83-7.23, p = 0.107). At Week 24, patients in the maximal intervention group had fewer medication days (mean difference = -2.23, 95% CI = -3.76 to -0.70, p = 0.005). This difference receded over time. Change in monthly migraine days did not differ between groups (-6.75 vs. -6.22).
CONCLUSIONS


This trial suggests modest benefit of behavioural intervention by a headache nurse during withdrawal therapy for medication overuse headache, to reduce acute medication use during and shortly after intervention, but extension seems warranted for a prolonged effect.",2022,"At week 24, patients in the maximal intervention group had fewer medication days (mean difference -2.23, 95%CI: -3.76;-0.70, p=0.005).","['medication overuse headache', 'We enrolled 179 patients (90 maximal; 89 minimal intervention']","['maximal versus minimal behavioural intervention', 'intensive contact schedule, comprising of education, motivational interviewing and value-based activity planning', 'behavioural intervention', 'Behavioural intervention']",['medication days'],"[{'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",179.0,0.484973,"At week 24, patients in the maximal intervention group had fewer medication days (mean difference -2.23, 95%CI: -3.76;-0.70, p=0.005).","[{'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Pijpers', 'Affiliation': 'Department of Neurology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Kies', 'Affiliation': 'Department of Neurology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Erik W', 'Initials': 'EW', 'LastName': 'van Zwet', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Frits R', 'Initials': 'FR', 'LastName': 'Rosendaal', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Gisela M', 'Initials': 'GM', 'LastName': 'Terwindt', 'Affiliation': 'Department of Neurology, Leiden University Medical Centre, Leiden, the Netherlands.'}]",European journal of neurology,['10.1111/ene.15256']
354,34420037,"Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk.","BACKGROUND


While enzalutamide plus androgen deprivation therapy (ADT) significantly reduces the risk of radiographic progression-free survival (rPFS) and improves overall survival in metastatic hormone-sensitive prostate cancer (mHSPC), the efficacy in clinically relevant subgroups of patients based on prior local and systemic therapy, disease volume, and risk has not been analyzed to date. These post hoc analyses of the phase 3 ARCHES trial (NCT02677896) evaluated the efficacy of enzalutamide plus ADT according to prior local and systemic treatment, disease volume, and risk, assessed at trial baseline.
METHODS


In ARCHES, a global, double-blind, placebo-controlled, phase 3 study, 1150 patients with mHSPC were randomized 1:1 to receive enzalutamide (160 mg/day) plus ADT or placebo plus ADT, stratified by prior docetaxel therapy and disease volume. Primary endpoint was rPFS. Secondary endpoints included time to prostate-specific antigen progression, symptomatic skeletal events, and prostate-specific antigen and radiographic responses. Analyses of clinical endpoints were completed by prior local therapy, prior docetaxel exposure, CHAARTED (NCT00309985)-defined disease volume, and LATITUDE (NCT01715285)-defined risk groups.
RESULTS


Patients were randomized to enzalutamide plus ADT (n = 574) and placebo plus ADT (n = 576). Enzalutamide plus ADT significantly improved rPFS (hazard ratio: 0.39; p < 0.0001), with similar improvements reported in all subgroups based on prior local and docetaxel treatment, disease volume, and risk. Treatment benefits were observed with enzalutamide plus ADT in multiple secondary clinical endpoints in the overall population and all subgroups.
CONCLUSIONS


Enzalutamide plus ADT demonstrated clinical benefit across all patients with mHSPC, irrespective of prior local and systemic treatment, disease volume, and risk.",2022,"Enzalutamide plus ADT significantly improved rPFS (hazard ratio: 0.39; p < 0.0001), with similar improvements reported in all subgroups based on prior local and docetaxel treatment, disease volume, and risk.","['subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk', '1150 patients with mHSPC']","['enzalutamide', 'enzalutamide plus androgen deprivation therapy (ADT', 'placebo plus ADT', 'Enzalutamide plus ADT', 'enzalutamide plus ADT', 'placebo', 'ADT or placebo plus ADT, stratified by prior docetaxel therapy and disease volume']","['overall survival', 'risk of radiographic progression-free survival (rPFS', 'rPFS', 'time to prostate-specific antigen progression, symptomatic skeletal events, and prostate-specific antigen and radiographic responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]",1150.0,0.214632,"Enzalutamide plus ADT significantly improved rPFS (hazard ratio: 0.39; p < 0.0001), with similar improvements reported in all subgroups based on prior local and docetaxel treatment, disease volume, and risk.","[{'ForeName': 'Arun A', 'Initials': 'AA', 'LastName': 'Azad', 'Affiliation': 'Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Duke Cancer Institute Center for Prostate & Urologic Cancers, Durham, NC, USA. andrew.armstrong@duke.edu.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Alcaraz', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Russell Z', 'Initials': 'RZ', 'LastName': 'Szmulewitz', 'Affiliation': 'The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale Cancer Center, New Haven, CT, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Holzbeierlein', 'Affiliation': 'The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Lille University, Lille, France.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'Hertzen Moscow Cancer Research Institute, Moscow, Russia.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Iguchi', 'Affiliation': 'Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gomez-Veiga', 'Affiliation': 'University Hospital, GITUR-IBSAL, University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Rosbrook', 'Affiliation': 'Pfizer Inc., San Diego, CA, USA.'}, {'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Astellas Pharma Inc., Northbrook, IL, USA.'}, {'ForeName': 'Gabriel P', 'Initials': 'GP', 'LastName': 'Haas', 'Affiliation': 'Astellas Pharma Inc., Northbrook, IL, USA.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00436-y']
355,34433377,Transcranial Direct Current Stimulation Reduces the Negative Impact of Mental Fatigue on Swimming Performance.,"The issue of using transcranial direct current stimulation (tDCS) to improve sport performance has recently been a topic of interest for researchers. The purpose of this study was to examine the effect of tDCS over left dorsolateral prefrontal cortex (DLPFC) on mental fatigue and physical performance in professional swimmers. Fifteen professional swimmers were randomly assigned in a single-blinded, randomized, counterbalanced order to sham, anodal and cathodal stimulation conditions. Mental fatigue was induced by using a 60-min modified Stroop color-word task. Subjective ratings of mental fatigue were measured before and after the stroop task. The results showed that only anodal tDCS of the left DLPFC reduces adverse effects of mental fatigue in 50-meter swimming performance, whereas cathodal stimulation had no significant effect.",2022,"The results showed that only anodal tDCS of the left DLPFC reduces adverse effects of mental fatigue in 50-meter swimming performance, whereas cathodal stimulation had no significant effect.","['professional swimmers', 'Fifteen professional swimmers']","['anodal and cathodal stimulation conditions', 'transcranial direct current stimulation (tDCS', 'tDCS', 'Transcranial Direct Current Stimulation']","['Subjective ratings of mental fatigue', 'mental fatigue and physical performance', 'adverse effects of mental fatigue', 'Mental fatigue']","[{'cui': 'C0450068', 'cui_str': 'Swimmer'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",15.0,0.0872311,"The results showed that only anodal tDCS of the left DLPFC reduces adverse effects of mental fatigue in 50-meter swimming performance, whereas cathodal stimulation had no significant effect.","[{'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Nikooharf Salehi', 'Affiliation': 'Department of Motor Behavior and Sport Psychology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Jaydari Fard', 'Affiliation': 'Institute for Social Science Research, Faculty of Humanities and Social Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zoghi', 'Affiliation': 'Discipline of Physiotherapy, Department of Rehabilitation, Nutrition and Sport, School of Allied Health, La Trobe University, Melbourne, Australia.'}]",Journal of motor behavior,['10.1080/00222895.2021.1962238']
356,34404091,Local vibration therapy increases oxygen re-saturation rate and maintains muscle strength following exercise-induced muscle damage.,"CONTEXT


Exercise induced muscle damage (EIMD) is associated with transient reductions in strength and athletic performance. Studies conclude aetiology is due in part to muscle micro vascular damage and disruption of blood flow. Previous research on vibration therapy reports modulation in muscle blood flow, oxygenation and strength.
OBJECTIVE


The aim of this study was to observe if local vibration therapy (VT) alleviates the impairments and haemodynamic changes associated with EIMD.
DESIGN


Controlled laboratory study.
SETTING


Laboratory and public gymnasium.
PATIENTS OR OTHER PARTICIPANTS


Ten healthy participants (6 males: 4 females; age: 38±15 yrs; height: 1.72±0.48 m; mass 72.0±10.4 kg) were randomized into experimental (VT) and control (CON) groups.
INTERVENTIONS


Both groups performed 10 sets of 10 eccentric wrist flexions at 70% of 1-repetition maximum to induce muscle damage. Subsequent assessment of wrist flexor strength and flexor carpus ulnaris (FCU) muscle oxygen saturation (SmO2) occurred at 1-, 24- and 48 hr-post exercise. VT group underwent 10 min of local VT (45 Hz) starting 1 hr-post exercise and applied twice daily (separated by 8 hrs) for 48 hrs during habitual waking hours. CON group received no local VT.
MAIN OUTCOME MEASURE(S)


Grip strength, resting muscle oxygen (SmO2), muscle oxygen de-saturation and re-saturation rate.
RESULTS


No difference in grip strength observed pre EIMD, but the VT group demonstrated greater strength at 1 hr (P=0.004), 24 hr (P=0.031) and 48 hr (P=0.021) post EIMD compared to controls. No difference in SmO2 re-saturation over time (P>0.05), but the VT group had a greater re-saturation rate compared to controls at 1 hr (P=0.007, d = 2.6), 24 hr (P=0.001 d = 3.1) and 48 hr (P=0.035, d = 1.7) post EIMD.
CONCLUSIONS


Local VT successfully attenuated the effects of EIMD and increased SmO2 re-saturation in FCU muscles. Including local VT as part of a recovery protocol post-EIMD could be beneficial for rehabilitation and athletic training purposes.",2021,Subsequent assessment of wrist flexor strength and flexor carpus ulnaris (FCU) muscle oxygen saturation (SmO2) occurred at 1-,"['Laboratory and public gymnasium', 'Ten healthy participants (6 males: 4 females; age: 38±15 yrs; height: 1.72±0.48 m; mass 72.0±10.4 kg']","['Local vibration therapy', 'local vibration therapy (VT', 'CON', 'local VT']","['muscle blood flow, oxygenation and strength', 'grip strength observed pre EIMD', 're-saturation rate', 'greater strength', 'wrist flexor strength and flexor carpus ulnaris (FCU) muscle oxygen saturation (SmO2', 'SmO2 re-saturation', 'effects of EIMD and increased SmO2 re-saturation', 'oxygen re-saturation rate and maintains muscle strength', 'Grip strength, resting muscle oxygen (SmO2), muscle oxygen de-saturation and re-saturation rate']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442572', 'cui_str': 'Gymnasium'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",10.0,0.0164724,Subsequent assessment of wrist flexor strength and flexor carpus ulnaris (FCU) muscle oxygen saturation (SmO2) occurred at 1-,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Percival', 'Affiliation': 'Department of Sport and Exercise Sciences, Musculoskeletal Science and Sports Medicine Research Centre, Manchester Metropolitan University, UK.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Sims', 'Affiliation': 'Department of Sport and Exercise Sciences, Musculoskeletal Science and Sports Medicine Research Centre, Manchester Metropolitan University, UK.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Stebbings', 'Affiliation': 'Department of Sport and Exercise Sciences, Musculoskeletal Science and Sports Medicine Research Centre, Manchester Metropolitan University, UK.'}]",Journal of athletic training,['10.4085/1062-6050-0064.21']
357,34417781,Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6.,"PURPOSE


To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema after cataract surgery in diabetic patients.
SETTING


7 ophthalmology clinics in the Netherlands and Belgium.
DESIGN


Prospective trial-based cost-effectiveness analysis using data from a European multicenter randomized clinical trial.
METHODS


Diabetic patients (n = 163) undergoing uneventful cataract surgery were randomized to perioperative subconjunctival triamcinolone acetonide (n = 36), perioperative intravitreal bevacizumab (n = 36), combination treatment (n = 45), or no additional treatment (control group, n = 46). The cost analysis was performed from a healthcare perspective within a 12-week postoperative time horizon. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER; cost per QALY).
RESULTS


The mean total healthcare costs and QALYs were as follows: triamcinolone group €1827 (U.S. dollars [$] 2295)/0.166; bevacizumab group €2050 ($2575)/0.144; combination group €2027 ($2546)/0.166; and control group €2041 ($2564)/0.156. Bevacizumab and control treatment were most costly and least effective. The ICER was €321 984 ($404 503) per QALY for the combination group compared with that of the triamcinolone group. Assuming the willingness-to-pay as €20 000 ($25 126) per QALY, the cost-effectiveness probability was 70% and 23% in the triamcinolone and combination groups, respectively. No patient who received triamcinolone developed clinically significant macular edema (CSME). A secondary cost-effectiveness analysis based on this outcome showed a clear preference for triamcinolone.
CONCLUSIONS


In diabetic patients, subconjunctival triamcinolone was effective in preventing CSME after cataract surgery. The cost-effectiveness analysis showed that triamcinolone is also cost-effective.",2022,"The ICER was € 321,984 (US$ 404,503) per QALY for the combination group compared to the triamcinolone group.","['Diabetic patients (n=163) undergoing uncomplicated cataract surgery', 'diabetic patients', 'cystoid macular edema (CME) after cataract surgery in diabetic patients', 'Seven ophthalmology clinics in the Netherlands and Belgium', 'cystoid macular edema after cataract surgery in diabetic patients']","['Bevacizumab', 'Triamcinolone', 'perioperative subconjunctival triamcinolone acetonide', 'triamcinolone', 'perioperative intravitreal bevacizumab', 'subconjunctival triamcinolone']","['Mean total healthcare costs and QALYs', 'cost-effectiveness probability', 'quality-adjusted life years (QALYs', 'incremental cost-effectiveness ratio (ICER; cost per QALY', 'macular edema (CSME']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3838844', 'cui_str': 'Ophthalmology clinic'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0730284', 'cui_str': 'Clinically significant macular edema'}]",163.0,0.0905166,"The ICER was € 321,984 (US$ 404,503) per QALY for the combination group compared to the triamcinolone group.","[{'ForeName': 'Rob W P', 'Initials': 'RWP', 'LastName': 'Simons', 'Affiliation': 'From the University Eye Clinic Maastricht, Maastricht University Medical Center+, Maastricht, the Netherlands (Simons, Wielders, Nuijts, Veldhuizen, van den Biggelaar, Schouten); Department of Ophthalmology, Zuyderland Medical Center Heerlen, Sittard-Geleen, the Netherlands (Simons, Wielders, Nuijts, Schouten); Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Center+, Maastricht, the Netherlands (Winkens); Department of Ophthalmology, Canisius Wilhelmina Hospital, Nijmegen, Netherlands (Schouten); Department of Clinical Epidemiology and Medical Technology Assessment, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Center+, Maastricht, the Netherlands (Dirksen).'}, {'ForeName': 'Laura H P', 'Initials': 'LHP', 'LastName': 'Wielders', 'Affiliation': ''}, {'ForeName': 'Rudy M M A', 'Initials': 'RMMA', 'LastName': 'Nuijts', 'Affiliation': ''}, {'ForeName': 'Claudette A', 'Initials': 'CA', 'LastName': 'Veldhuizen', 'Affiliation': ''}, {'ForeName': 'Frank J H M', 'Initials': 'FJHM', 'LastName': 'van den Biggelaar', 'Affiliation': ''}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': ''}, {'ForeName': 'Jan S A G', 'Initials': 'JSAG', 'LastName': 'Schouten', 'Affiliation': ''}, {'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Dirksen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000785']
358,35064574,Consumption of caffeinated and decaffeinated coffee enriched with cocoa and fructo-oligosaccharides among non-diabetic persons: Double blind randomized clinical trial.,"Food industry has been investing in bringing to the market coffee-based drinks enriched in compounds that promise weight loss, which consequently influences diabetes risk. However, there are no clinical trials showing the effects of brewed coffee (with or without caffeine) enriched with bioactive compounds on body fat and glycemic control in healthy individuals. Therefore, we have evaluated the effect of consuming two coffee formulas enriched with cocoa and fructo-oligosaccharides (FOS) on glycemic and anthropometric biomarkers and blood pressure in non-diabetic adults for 10 weeks. In general, we observed that the values of fasting plasma glucose (FPG) (p = .006) and fasting capillary blood glucose (FCBG) (p < .001) had lower values with a tendency to decrease in FCG (p = .003) and FBG (p < .005) in both formulas. We observed statistically significant reductions in waist circumference (WC) (p = .012), arm circumference (AC) (p = .015), and percentage of fat (<0.0001) for all participants. However, we noticed a greater reduction in the caffeinated formula group (-2.92%, p = .005) compared to the decaffeinated formula (-1.62%, p = .008). Consumers of both cocoa and FOS-enriched coffee formulas benefited from reduced FBG, FCG, WC, and body fat percentage. The consumption of caffeinated formula was more effective in reducing the percentage of fat, while the decaffeinated formula was more effective in reducing diastolic blood pressure. PRACTICAL APPLICATIONS: This study provides robust evidence that effects of fortified coffee on non-diabetic people is positive for reduction in blood glucose, body fat and diastolic blood pressure. This study proposes a practical and safe coffee formulation for the consumption of caffeinated and decaffeinated coffee for non-diabetic people.",2022,"We observed statistically significant reductions in waist circumference (WC) (p = .012), arm circumference (AC) (p = .015), and percentage of fat (<0.0001) for all participants.","['non-diabetic people', 'non-diabetic persons', 'non-diabetic adults for 10\xa0weeks', 'healthy individuals']","['cocoa and fructo-oligosaccharides (FOS', 'brewed coffee (with or without caffeine', 'Consumption of caffeinated and decaffeinated coffee enriched with cocoa and fructo-oligosaccharides', 'fortified coffee']","['glycemic and anthropometric biomarkers and blood pressure', 'body fat and glycemic control', 'percentage of fat', 'arm circumference (AC', 'diastolic blood pressure', 'blood glucose, body fat and diastolic blood pressure', 'fasting capillary blood glucose (FCBG', 'FBG, FCG, WC, and body fat percentage', 'FBG', 'FCG', 'waist circumference (WC', 'values of fasting plasma glucose (FPG']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",,0.0534052,"We observed statistically significant reductions in waist circumference (WC) (p = .012), arm circumference (AC) (p = .015), and percentage of fat (<0.0001) for all participants.","[{'ForeName': 'Márcio Flávio', 'Initials': 'MF', 'LastName': 'Moura de Araújo', 'Affiliation': 'Health Family, Oswaldo Cruz Foundation, Eusébio, Brazil.'}, {'ForeName': 'Maria Wendiane', 'Initials': 'MW', 'LastName': 'Gueiros Gaspar', 'Affiliation': 'Nursing Department, University for International Integration Lusophony Afro Brazilian, Redenção, Brazil.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Saraiva Veras', 'Affiliation': 'Nursing Department, University for International Integration Lusophony Afro Brazilian, Redenção, Brazil.'}, {'ForeName': 'Roberto Wagner Júnior', 'Initials': 'RWJ', 'LastName': 'Freire de Freitas', 'Affiliation': 'Health Family, Oswaldo Cruz Foundation, Eusébio, Brazil.'}, {'ForeName': 'Maria do Livramento', 'Initials': 'MDL', 'LastName': 'de Paula', 'Affiliation': 'Pharmacy Department, University of Maranhão, São Luís, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'Alves de Oliveira Serra', 'Affiliation': 'Nursing Department, Federal University of Maranhão, Imperatriz, Brazil.'}, {'ForeName': 'José Claudio', 'Initials': 'JC', 'LastName': 'Garcia Lira Neto', 'Affiliation': 'Medicine Department, Universidade de Ribeirão Preto, Ribeirão Prêto, Brazil.'}, {'ForeName': 'Marta Maria', 'Initials': 'MM', 'LastName': 'Coelho Damasceno', 'Affiliation': 'Nursing Department, Nursing, Dentist and Pharmacy Faculty, Ceará Federal University, Fortaleza, Brazil.'}, {'ForeName': 'Ana Vládia', 'Initials': 'AV', 'LastName': 'Bandeira Moreira', 'Affiliation': 'Nutrition Department, Juiz de Fora Federal University, Juiz de Fora, Brazil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Derenji de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Eastern University of Finland, Kuopio, Finland.'}]",Journal of food biochemistry,['10.1111/jfbc.14081']
359,35046508,"Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial.","This study tested the efficacy of repeated intravenous ketamine doses to reduce symptoms of posttraumatic stress disorder (PTSD). Veterans and service members with PTSD (n = 158) who failed previous antidepressant treatment were randomized to 8 infusions administered twice weekly of intravenous placebo (n = 54), low dose (0.2 mg/kg; n = 53) or standard dose (0.5 mg/kg; n = 51) ketamine. Participants were assessed at baseline, during treatment, and for 4 weeks after their last infusion. Primary analyses used mixed effects models. The primary outcome measure was the self-report PTSD Checklist for DSM-5 (PCL-5), and secondary outcome measures were the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the Montgomery Åsberg Depression Rating Scale (MADRS). There were no significant group-by-time interactions for PTSD symptoms measured by the PCL-5 or CAPS-5. The standard ketamine dose ameliorated depression measured by the MADRS significantly more than placebo. Ketamine produced dose-related dissociative and psychotomimetic effects, which returned to baseline within 2 h and were less pronounced with repeated administration. There was no evidence of differential treatment discontinuation by ketamine dose, consistent with good tolerability. This clinical trial failed to find a significant dose-related effect of ketamine on PTSD symptoms. Secondary analyses suggested that the standard dose exerted rapid antidepressant effects. Further studies are needed to determine the role of ketamine in PTSD treatment. ClinicalTrials.gov identifier: NCT02655692.",2022,There were no significant group-by-time interactions for PTSD symptoms measured by the PCL-5 or CAPS-5.,"['posttraumatic stress disorder in veterans and active duty military', 'posttraumatic stress disorder (PTSD', 'Veterans and service members with PTSD (n\u2009=\u2009158) who failed previous antidepressant treatment']","['ketamine', 'intravenous placebo', 'placebo', 'Ketamine']","['self-report PTSD Checklist for DSM-5 (PCL-5), and secondary outcome measures were the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the Montgomery Åsberg Depression Rating Scale (MADRS', 'PTSD symptoms', 'depression']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.216624,There were no significant group-by-time interactions for PTSD symptoms measured by the PCL-5 or CAPS-5.,"[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA. chadi.abdallah@bcm.edu.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, School of Public Health, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Paulo R', 'Initials': 'PR', 'LastName': 'Shiroma', 'Affiliation': 'Minneapolis VA Medical Center and the Department of Psychiatry University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Purohit', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Brundige', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Murff', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Sherif', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Baltutis', 'Affiliation': 'Minneapolis VA Medical Center and the Department of Psychiatry University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Martini', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ismene L', 'Initials': 'IL', 'LastName': 'Petrakis', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Burson', 'Affiliation': 'Department of Behavioral Health, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Guthmiller', 'Affiliation': 'Department of Pain Management, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Argelio L', 'Initials': 'AL', 'LastName': 'López-Roca', 'Affiliation': 'Department of Behavioral Health, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Karl A', 'Initials': 'KA', 'LastName': 'Lautenschlager', 'Affiliation': 'Department of Pain Management, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCallin', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Hoch', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Alexandar', 'Initials': 'A', 'LastName': 'Timchenko', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Sergio E', 'Initials': 'SE', 'LastName': 'Souza', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Bryant', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiology Research and Information Center, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Health, Durham, NC, USA.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-022-01266-9']
360,35065738,"Self-expandable metal stents versus endoscopic balloon dilation for the treatment of strictures in Crohn's disease (ProtDilat study): an open-label, multicentre, randomised trial.","BACKGROUND


Endoscopic balloon dilation (EBD) is the established endoscopic treatment for short strictures in Crohn's disease. Fully covered self-expandable metal stents (FCSEMS) have been used for endoscopic treatment of patients for whom EBD was unsuccessful. We aimed to determine the efficacy and safety of the two endoscopic treatments in patients with Crohn's disease with stenosis and compare the mean cost of both treatments.
METHODS


This multicentre, open-label, randomised trial was done in 19 tertiary and secondary hospitals in Spain. Patients with Crohn's disease with obstructive symptoms and predominantly fibrotic strictures of less than 10 cm in length were eligible for inclusion. We excluded patients with stenosis treated with SEMS or EBD in the previous year and stenosis not accessible to a colonoscope. Patients were randomly assigned (1:1) to receive either EBD (EBD group) or FCSEMS (FCSEMS group) using a digital en-block randomisation system (block size of four). In the EBD group, dilation was done with a CRE Boston Scientific (Marlborough, MA, USA) pneumatic balloon with the diameter set at the discretion of the endoscopist; a maximum of two sessions of dilation were allowed with a minimum interval of 15-30 days between them. In the FCSEMS group, a 20 mm diameter Taewoong (Gimpo-si, South Korea) fully covered metal stent was placed; stent length was set at the discretion of the endoscopist. The primary outcome was to assess the efficacy of the endoscopic treatment, defined by the proportion of patients free of a new therapeutic intervention (EBD, FCSEMS, or surgery) due to symptomatic recurrence at 1 year of follow-up. Patients were analysed according to the intention-to-treat principle. Adverse events were recorded for all the patients; events were considered associated to be with the procedure when a causal association was possible, probable, or definite. This trial is registered with ClinicalTrials.gov, NCT02395354.
FINDINGS


From Aug 28, 2013, to Oct 9, 2017, we assessed the eligibility of 99 patients, of whom 19 (19%) patients were excluded. Thus, 80 (81%) patients were randomly assigned to treatment: 39 (49%) patients to the FCSEMS group and 41 (51%) patients to the EBD group. 33 (80%) of 41 patients in the EBD group and 20 (51%) of 39 patients in the FCSEMS group were free of a new therapeutic intervention at 1 year (odds ratio [OR] 3·9 [95% CI 1·4-10·6]; p=0·0061). Two (3%) of 80 patients had severe adverse events (one [2%] patient in the EBD group and one [3%] patient in the FCSEMS group); both patients had perforations.
INTERPRETATION


EBD is more effective than FCSEMS for Crohn's disease strictures, with a good safety profile for both treatments.
FUNDING


Spanish National Institute of Health, Foundation of Spanish Society of Digestive Endoscopy, Catalan Society of Gastroenterology, and Taweoong.",2022,"Two (3%) of 80 patients had severe adverse events (one [2%] patient in the EBD group and one [3%] patient in the FCSEMS group); both patients had perforations.
","[""short strictures in Crohn's disease"", 'patients with stenosis treated with SEMS or EBD in the previous year and stenosis not accessible to a colonoscope', ""strictures in Crohn's disease (ProtDilat study"", ""patients with Crohn's disease with stenosis"", ""Patients with Crohn's disease with obstructive symptoms and predominantly fibrotic strictures of less than 10 cm in length were eligible for inclusion"", '99 patients, of whom 19 (19%) patients were excluded', '19 tertiary and secondary hospitals in Spain']","['Self-expandable metal stents versus endoscopic balloon dilation', 'Endoscopic balloon dilation (EBD', 'Fully covered self-expandable metal stents (FCSEMS', 'FCSEMS', 'EBD (EBD group) or FCSEMS (FCSEMS group) using a digital en-block randomisation system (block size of four']","['severe adverse events', 'Adverse events', 'efficacy and safety', 'efficacy of the endoscopic treatment, defined by the proportion of patients free of a new therapeutic intervention (EBD, FCSEMS, or surgery) due to symptomatic recurrence']","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0180022', 'cui_str': 'Colonoscope'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C4042807', 'cui_str': 'Self Expandable Metallic Stent'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metallic Stent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.203297,"Two (3%) of 80 patients had severe adverse events (one [2%] patient in the EBD group and one [3%] patient in the FCSEMS group); both patients had perforations.
","[{'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Loras', 'Affiliation': 'Department of Gastroenterology, Universitat de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain. Electronic address: cloras@mutuaterrassa.cat.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Andújar', 'Affiliation': 'Department of Gastroenterology, Universitat de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Gornals', 'Affiliation': 'Digestive Diseases Department, Hospital Universitari de Bellvitge, Barcelona, Spain; Bellvitge Biomedical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Sanchiz', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Brullet', 'Affiliation': 'Corporació Sanitària Universitària Parc Taulí, Sabadell, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Sicilia', 'Affiliation': 'Complejo Asistencial Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Martín-Arranz', 'Affiliation': 'Department of Gastroenterology, La Paz University Hospital, Madrid, Spain; School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Barrio', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Dueñas', 'Affiliation': 'Department of Gastroenterology, Hospital San Pedro de Alcántara, Cáceres, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Foruny', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Busquets', 'Affiliation': 'Department of Gastroenterology, Hospital Universitari Dr Josep Trueta, Girona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Monfort', 'Affiliation': 'Department of Gastroenterology, Consorci Sanitari de Terrassa, Barcelona, Spain.'}, {'ForeName': 'Juan Ramón', 'Initials': 'JR', 'LastName': 'Pineda', 'Affiliation': 'Department of Gastroenterology, Xerencia Xestion Integrada de Vigo, SERGAS, Vigo, Spain; Research Group in Digestive Diseases, Galicia Sur Health Research Institute, SERGAS-UVIGO, Vigo, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'González-Huix', 'Affiliation': 'Department of Gastroenterology, Clínica de Girona, Girona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Pérez-Roldán', 'Affiliation': 'Department of Gastroenterology, Hospital General La Mancha Centro, Alcázar de San Juan, Ciudad Real, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Pons', 'Affiliation': 'Digestive Endoscopy Unit, La Fe Polytechnic University Hospital, Gastrointestinal Endoscopy Research Group IIS La Fe, Valencia, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'González', 'Affiliation': 'Department of Gastroenterology, Hospital Clínic i Provincial de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Reyes Moreno', 'Affiliation': ""Department of Gastroenterology, Hospital Comarcal d'Inca, Inca, Mallorca, Spain.""}, {'ForeName': 'Empar', 'Initials': 'E', 'LastName': 'Sainz', 'Affiliation': 'Department of Gastroenterology, Hospital Universitari Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Guardiola', 'Affiliation': 'Digestive Diseases Department, Hospital Universitari de Bellvitge, Barcelona, Spain; Bellvitge Biomedical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Marta Maia', 'Initials': 'MM', 'LastName': 'Bosca-Watts', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Fernández-Bañares', 'Affiliation': 'Department of Gastroenterology, Universitat de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Mayor', 'Affiliation': 'Hospital Universitari Mútua Terrassa, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Esteve', 'Affiliation': 'Department of Gastroenterology, Universitat de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(21)00386-1']
361,35072661,"Effects of a 10-Month Neuromuscular Training Program on Strength, Power, Speed, and Vault Performance in Young Female Gymnasts.","PURPOSE


This study aimed to evaluate a 10-month neuromuscular training (NMT) intervention on isometric and dynamic kinetics, standing long jump (SLJ) distance, speed, and sport-specific performance.
METHODS


Forty-three prepubertal female gymnasts were allocated into either a gymnastics + NMT (gNMT; n = 16), gymnastics only (GYM, n = 15), or maturity-matched control (CON; n = 12) group. The gNMT followed a 10-month, twice-weekly NMT program that targeted movement competency, strength, power, and speed. Vaulting vertical take-off velocity, speed, SLJ distance, and kinetics during an isometric mid-thigh pull (IMTP), countermovement jump (CMJ), and drop jump (DJ) were measured at baseline and thereafter at 4, 7, and 10 months. Within-group differences were calculated using 3 × 4 repeated-measures ANCOVA.
RESULTS


Interaction effects were observed for SLJ distance and various IMTP, DJ, and vaulting variables. The gNMT showed significant improvements in IMTP absolute force and SLJ distance after 4 months and each subsequent testing session. IMTP relative force and various CMJ and DJ kinetics significantly improved in the gNMT from 7 months. Significant gains in speed and vaulting take-off velocity occurred after 10 months. The GYM group achieved some significant improvements in CMJ impulse, absolute isometric strength, and DJ spring-like behavior, whereas the CON group did not experience any changes.
CONCLUSIONS


The addition of NMT to gymnastics training improved various isometric and dynamic kinetics, SLJ distance, speed, and vaulting take-off velocity in the gNMT, changes that were not equally evidenced for GYM or CON. The threshold for most of the training-induced adaptations observed in IMTP relative force, CMJ and DJ kinetics, sprint speed, and vaulting were achieved after 7 months, emphasizing the efficacy of long-term NMT programs for young gymnasts.",2022,"The gNMT showed significant improvements in IMTP absolute force and SLJ distance after 4-months, and each subsequent testing session.","['Forty-three pre-pubertal female gymnasts', 'Young Female Gymnasts']","['gymnastics + NMT (gNMT', 'neuromuscular training (NMT) intervention', 'gymnastics only (GYM, n = 15) or maturity-matched control (CON', 'Neuromuscular Training Program']","['IMTP relative force, CMJ and DJ kinetics, sprint speed and vaulting', 'IMTP relative force and various CMJ and DJ kinetics', 'Strength, Power, Speed and Vault Performance', 'IMTP absolute force and SLJ distance', 'CMJ impulse, absolute isometric strength and DJ spring-like behaviour', 'Vaulting vertical take-off velocity, speed, SLJ distance and kinetics during an isometric mid-thigh pull (IMTP), countermovement jump (CMJ) and drop jump (DJ', 'isometric and dynamic kinetics, standing long jump (SLJ) distance, speed and sport-specific performance', 'Significant gains in speed and vaulting take-off velocity', 'SLJ distance and various IMTP, DJ and vaulting variables', 'various isometric and dynamic kinetics, SLJ distance, speed and vaulting take-off velocity']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",43.0,0.0265304,"The gNMT showed significant improvements in IMTP absolute force and SLJ distance after 4-months, and each subsequent testing session.","[{'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Moeskops', 'Affiliation': 'Youth Physical Development Centre, Cardiff School of Sport, Cardiff Metropolitan University, Cardiff, UNITED KINGDOM.'}, {'ForeName': 'Jon L', 'Initials': 'JL', 'LastName': 'Oliver', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Read', 'Affiliation': ''}, {'ForeName': 'G Gregory', 'Initials': 'GG', 'LastName': 'Haff', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, AUSTRALIA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Myer', 'Affiliation': ''}, {'ForeName': 'Rhodri S', 'Initials': 'RS', 'LastName': 'Lloyd', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002862']
362,35072660,"Physiological, Perceptual, and Performance Responses to the 2-Week Block of High- versus Low-Intensity Endurance Training.","PURPOSE


This study examined the physiological, perceptual, and performance responses to a 2-wk block of increased training load and compared whether responses differ between high-intensity interval (HIIT) and low-intensity training (LIT).
METHODS


Thirty recreationally trained males and females performed a 2-wk block of 10 HIIT sessions (INT, n = 15) or 70% increased volume of LIT (VOL, n = 15). Running time in the 3000 m and basal serum and urine hormone concentrations were measured before (T1) and after the block (T2), and after a recovery week (T3). In addition, weekly averages of nocturnal heart rate variability (HRV) and perceived recovery were compared with the baseline.
RESULTS


Both groups improved their running time in the 3000 m from T1 to T2 (INT = -1.8% ± 1.6%, P = 0.003; VOL = -1.4% ± 1.7%, P = 0.017) and from T1 to T3 (INT = -2.5% ± 1.6%, P < 0.001; VOL = -2.2% ± 1.9%, P = 0.001). Resting norepinephrine concentration increased in INT from T1 to T2 (P = 0.01) and remained elevated at T3 (P = 0.018). The change in HRV from the baseline was different between the groups during the first week (INT = -1.0% ± 2.0% vs VOL = 1.8% ± 3.2%, P = 0.008). Muscle soreness increased only in INT (P < 0.001), and the change was different compared with VOL across the block and recovery weeks (P < 0.05).
CONCLUSIONS


HIIT and LIT blocks increased endurance performance in a short period. Although both protocols seemed to be tolerable for recreational athletes, a HIIT block may induce some negative responses such as increased muscle soreness and decreased parasympathetic activity.",2022,"Muscle soreness increased only in INT (p < 0.001) and the change was different compared to VOL across the block and recovery weeks (p < 0.05).
",['Thirty recreationally trained males and females'],"['high-intensity interval (HIIT) and low-intensity (LIT) endurance training', 'HIIT and LIT blocks', 'High- versus Low-Intensity Endurance Training']","['nocturnal heart rate variability (HRV) and perceived recovery', 'running time', 'endurance performance', 'basal serum and urine hormone concentrations', 'Resting norepinephrine concentration', 'Physiological, Perceptual, and Performance Responses', 'Muscle soreness', 'muscle soreness and decreased parasympathetic activity', 'change in HRV']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",30.0,0.0627705,"Muscle soreness increased only in INT (p < 0.001) and the change was different compared to VOL across the block and recovery weeks (p < 0.05).
","[{'ForeName': 'Olli-Pekka', 'Initials': 'OP', 'LastName': 'Nuuttila', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, FINLAND.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Nummela', 'Affiliation': 'KIHU - Research Institute for Olympic Sports, Jyväskylä, FINLAND.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kyröläinen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, FINLAND.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Laukkanen', 'Affiliation': ''}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, FINLAND.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002861']
363,35066508,The Effect of an Education Module to Reduce Weight Bias among Medical Centers Employees: A Randomized Controlled Trial.,"INTRODUCTION


Weight bias, stigma, and discrimination are common among healthcare professionals. We aimed to evaluate whether an online education module affects weight bias and knowledge about obesity in a private medical center setting.
METHODS


An open-label randomized controlled trial was conducted among all employees of a chain of private medical centers in Israel (n = 3,290). Employees who confirmed their consent to participate in the study were randomized into intervention or control (i.e., ""no intervention"") arms. The study intervention was an online 15-min educational module that included obesity, weight bias, stigma, and discrimination information. Questionnaires on Anti-Fat Attitudes (AFA), fat-phobia scale (F-scale), and beliefs about the causes of obesity were answered at baseline (i.e., right before the intervention), 7 days, and 30 days post-intervention.
RESULTS


A total of 506, 230, and 145 employees responded to the baseline, 7-day, and 30-day post-intervention questionnaires, respectively. Mean participant age was 43.3 ± 11.6 years, 84.6% were women, and 67.4% held an academic degree. Mean F-scale scores and percentage of participants with above-average fat-phobic attitudes (≥3.6) significantly decreased only within the intervention group over time (p ≤ 0.042). However, no significant differences between groups over time were observed for AFA scores or factors beliefs to cause obesity.
CONCLUSIONS


A single exposure to an online education module on weight bias and knowledge about obesity may confer only a modest short-term improvement in medical center employees' fat-phobic attitudes toward people with obesity. Future studies should examine if reexposure to such intervention could impact weight bias, stigma, and discrimination among medical center staff in the long-term.",2022,Mean F-scale scores and percentage of participants with above-average fat-phobic attitudes (≥3.6) significantly decreased only within the intervention group over time (P≤0.042).,"['Mean participant age was 43.3±11.6 years, 84.6% were women, and 67.4% held an academic degree', 'all employees of a chain of private medical centers in Israel (n=3,290', 'medical centers employees', 'A total of 506, 230, and 145 employees', 'medical center employees fat-phobic attitudes toward people with obesity']","['education module', 'online education module']","[""AFA'), fat-phobia ('F-scale), and beliefs about the causes of obesity"", 'AFA scores or factors beliefs to cause obesity', 'weight bias and knowledge about obesity', 'Mean F-scale scores and percentage of participants with above-average fat-phobic attitudes', 'weight bias', 'Anti-Fat Attitudes']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}]","[{'cui': 'C1565999', 'cui_str': '(11C)2-(2-(dimethylaminomethylphenylthio))-5-fluoromethylphenylamine'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0625178,Mean F-scale scores and percentage of participants with above-average fat-phobic attitudes (≥3.6) significantly decreased only within the intervention group over time (P≤0.042).,"[{'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Sherf-Dagan', 'Affiliation': 'Department of Nutrition Sciences, School of Health Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Kessler', 'Affiliation': 'Department of Nutrition Sciences, School of Health Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Limor', 'Initials': 'L', 'LastName': 'Mardy-Tilbor', 'Affiliation': 'Department of Nutrition, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Asnat', 'Initials': 'A', 'LastName': 'Raziel', 'Affiliation': 'Assia Medical Group, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Sakran', 'Affiliation': 'Assia Medical Group, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Boaz', 'Affiliation': 'Department of Nutrition Sciences, School of Health Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Kaufman-Shriqui', 'Affiliation': 'Department of Nutrition Sciences, School of Health Sciences, Ariel University, Ariel, Israel.'}]",Obesity facts,['10.1159/000521856']
364,35088616,Effects of patient-reported outcome assessment order.,"BACKGROUND


In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered.
METHODS


This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach's alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran-Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent.
RESULTS


A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106.
CONCLUSION


The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.",2022,"The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106.
","['1830 patients provided baseline patient-reported outcome assessments', 'adult cancer patients from five cancer centers']","['complete questionnaires via paper booklets, interactive voice response system, or tablet web survey']","[""Rates of missing data, scale scores, and Cronbach's alpha coefficients"", 'general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain', 'rates of missing values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",1830.0,0.16885,"The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106.
","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Novotny', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Satele', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Marlene H', 'Initials': 'MH', 'LastName': 'Frost', 'Affiliation': ""Women's Cancer Program, Mayo Clinic, Rochester, MN, USA.""}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Beebe', 'Affiliation': 'Division of Health Policy and Management, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Yost', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Minji K', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Eton', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Yount', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Tito R', 'Initials': 'TR', 'LastName': 'Mendoza', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Cleeland', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Blinder', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.'}, {'ForeName': 'Jeff A', 'Initials': 'JA', 'LastName': 'Sloan', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.'}]","Clinical trials (London, England)",['10.1177/17407745211073788']
365,35081771,Effects of Narrative Messages on Key COVID-19 Protective Responses: Findings From a Randomized Online Experiment.,"PURPOSE


We investigated the effectiveness of narrative vs non-narrative messages in changing COVID-19-related perceptions and intentions.
DESIGN/SETTING


The study employed a between-subjects two-group (narratives vs non-narratives) experimental design and was administered online.
SUBJECTS/INTERVENTION


1804 U.S. adults recruited via Amazon MTurk in September 2020 were randomly assigned to one of two experimental conditions and read either three narrative or three non-narrative messages about social distancing, vaccination, and unproven treatments.
MEASURES


Perceptions and intentions were assessed before and after message exposure (7-point scales).
ANALYSIS


Using multivariable regression, we assessed main effects of the experimental condition (controlling for baseline measures) and interactions between the condition and pre-exposure perceptions/intentions in predicting post-exposure outcomes.
RESULTS


Compared to non-narratives, narratives led to (1) less positive perceptions about the benefits of unproven treatments ( M narrative  = 3.60,  M non-narrative  = 3.77, P = .007); and (2) less willingness to receive an unproven drug ( M narrative  = 3.46,  M non-narrative  = 3.77, P < .001); this effect was stronger among individuals with higher baseline willingness to receive unproven drugs (baseline willingness = 2.09:  b  = -.06, P = .461; baseline willingness = 3.90:  b  = -.30, P < .001; baseline willingness = 5.71:  b  = -.55, P < .001). Narratives also led to more positive perceptions of vaccine safety/effectiveness, but only among individuals with lower baseline vaccine perceptions (baseline perceptions = 4.51:  b  = .10, P = .008; baseline perceptions = 5.89:  b  = .04, P = .167; baseline perceptions = 7:  b  = -.01, P = .688).
CONCLUSION


Narratives are a promising communication strategy, particularly for topics where views are not entrenched and among individuals who are more resistant to recommendations.",2022,"Narratives also led to more positive perceptions of vaccine safety/effectiveness, but only among individuals with lower baseline vaccine perceptions (baseline perceptions=4.51: b=0.10, p=.008; baseline perceptions=5.89: b=0.04, p=.167; baseline perceptions=7: b=-0.01, p=.688).
","['1,804 U.S. adults recruited via Amazon MTurk in September 2020']","['narrative or three non-narrative messages about social distancing, vaccination, and unproven treatments', 'narrative versus non-narrative messages', 'narrative messages']",['positive perceptions of vaccine safety/effectiveness'],"[{'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0456370', 'cui_str': 'Unproven'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.181488,"Narratives also led to more positive perceptions of vaccine safety/effectiveness, but only among individuals with lower baseline vaccine perceptions (baseline perceptions=4.51: b=0.10, p=.008; baseline perceptions=5.89: b=0.04, p=.167; baseline perceptions=7: b=-0.01, p=.688).
","[{'ForeName': 'Irina A', 'Initials': 'IA', 'LastName': 'Iles', 'Affiliation': '3421National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gaysynsky', 'Affiliation': '3421National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'Wen-Ying', 'Initials': 'WY', 'LastName': 'Sylvia Chou', 'Affiliation': 'ICF International Office.'}]",American journal of health promotion : AJHP,['10.1177/08901171221075612']
366,35080742,Efficacy and Safety of Combination Therapy with Tolvaptan and Furosemide in Children with Nephrotic Syndrome and Refractory Edema: A Prospective Interventional Study.,"OBJECTIVE


Severe edema in children with nephrotic syndrome is often refractory to conventional diuretics. Tolvaptan has been used satisfactorily for managing edema in patients with heart failure and cirrhosis. The safety and efficacy of combination therapy with oral tolvaptan and intravenous (IV) furosemide was assessed in patients with furosemide refractory edema.
METHODS


Patients, aged 5-18 y with nephrotic syndrome and severe edema, were screened for eligibility. After excluding hypovolemia, patients received IV furosemide (3-4 mg/kg/d) for 48 h. Those refractory to IV furosemide (weight loss < 3%) received tolvaptan (0.5-1 mg/kg once daily) and IV furosemide for the next 48 h. Parameters were compared between 48 h of furosemide alone and combination therapy.
RESULTS


A total of 24 patients (18 boys) with mean age of 8.0 ± 3.0 y were enrolled. Urine volume significantly increased with combination therapy as compared to furosemide therapy (mean difference: 1.2 mL/kg/h; 95% CI: 0.8-1.65 mL/kg/h) (p < 0.001). Compared to therapy with furosemide alone, combination therapy resulted in significant reduction in body weight from 26.9 ± 10.3 kg to 24.8 ± 9.7 kg (p < 0.001). Estimated glomerular filtration rate did not change (p = 0.81) but serum sodium increased from 135.7 ± 3.3 mEq/L to 140.4 ± 4.8 mEq/L (p < 0.001) with combination therapy; 2 patients showed asymptomatic hypernatremia.
CONCLUSION


The combination of oral tolvaptan and IV furosemide is effective in augmenting diuresis and reducing weight in patients with furosemide refractory edema but requires monitoring of electrolytes and volume status.",2022,Urine volume significantly increased with combination therapy as compared to furosemide therapy (mean difference: 1.2 mL/kg/h; 95% CI: 0.8-1.65 mL/kg/h) (p < 0.001).,"['24 patients (18 boys) with mean age of 8.0\u2009±', 'patients with heart failure and cirrhosis', 'Children with Nephrotic Syndrome and Refractory Edema', 'patients with furosemide refractory edema', '3.0 y were enrolled', 'children with nephrotic syndrome', 'Patients, aged 5-18 y with nephrotic syndrome and severe edema, were screened for eligibility']","['Tolvaptan and Furosemide', 'oral tolvaptan and intravenous (IV) furosemide', 'Tolvaptan', 'furosemide alone and combination therapy', 'tolvaptan', 'IV furosemide', 'furosemide', 'oral tolvaptan and IV furosemide']","['Urine volume', 'safety and efficacy', 'body weight', 'serum sodium', 'Efficacy and Safety', 'Estimated glomerular filtration rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",24.0,0.0799432,Urine volume significantly increased with combination therapy as compared to furosemide therapy (mean difference: 1.2 mL/kg/h; 95% CI: 0.8-1.65 mL/kg/h) (p < 0.001).,"[{'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Meena', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, ICMR Center for Advanced Research in Nephrology, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, ICMR Center for Advanced Research in Nephrology, All India Institute of Medical Sciences, New Delhi, 110029, India. pankajhari@hotmail.com.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, ICMR Center for Advanced Research in Nephrology, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Bagga', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, ICMR Center for Advanced Research in Nephrology, All India Institute of Medical Sciences, New Delhi, 110029, India.'}]",Indian journal of pediatrics,['10.1007/s12098-021-03988-y']
367,35083757,WeChat-based remote follow-up management alleviates the home care burden and anxiety of parents of premature infants: Randomized controlled study.,"OBJECTIVE


The purpose of this study was to explore the effect of WeChat-based remote follow-up management on reducing the home care burden and anxiety of parents of premature infants.
METHODS


A randomized controlled study was conducted in our hospital, with 150 premature infants enrolled in this study, each with 75 cases in the intervention group and the control group. WeChat-based remote follow-up management was performed in the intervention group after discharge, while traditional outpatient follow-up management was performed in the control group. Zarit Burden Interview (ZBI) scale as the primary outcome was used to compare the parental care burden between the two groups.
RESULTS


At the 1-month follow-up, the ZBI (37.1 ± 8.3 vs. 54.2 ± 10.5 [mean ± SD], mean difference: 17.1, the 95% confidence interval for the mean difference: [14.07, 20.13], P = 0.016), Family Caregiver Task Inventory (FCTI) scale (23.1 ± 5.2 vs. 33.4 ± 6.7 [mean ± SD], mean difference: 10.3, the 95% confidence interval for the mean difference: [8.38, 12.22], P = 0.023), Self-Rating Anxiety Scale (SAS) (49.6 ± 8.5 vs. 60.2 ± 10.8 [mean ± SD], mean difference: 10.6, the 95% confidence interval for the mean difference: [7.49,13.71], P = 0.021) and Self-Rating Depression Scale (SDS) (48.2 ± 9.5 vs. 58.8 ± 11.2 [mean ± SD], mean difference: 10.6, the 95% confidence interval for the mean difference: [7.28, 13.92], P = 0.019) scores of the intervention group were lower than those of the control group, and the lower scores indicate better outcomes.
CONCLUSION


WeChat-based remote follow-up management of premature infants after discharge can effectively improve parents' ability to care and their psychological state and reduce burden of care.",2022,"WeChat-based remote follow-up management of premature infants after discharge can effectively improve parents' ability to care and their psychological state, and reduce burden of care.","['parents of premature infants', 'parents of premature infants METHODS', '150 premature infants enrolled in this study, each with 75 cases in the intervention group control group']",['WeChat-based remote follow-up management'],"['Zarit Burden Interview (ZBI) scale', 'Self-Rating Anxiety Scale (SAS', 'Self-Rating Depression Scale (SDS', 'ZBI', 'Family Caregiver Task Inventory (FCTI) scale']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",150.0,0.139878,"WeChat-based remote follow-up management of premature infants after discharge can effectively improve parents' ability to care and their psychological state, and reduce burden of care.","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Pediatric, Fuzhou No. 1 Hospital Affiliated with Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatric, Fuzhou No. 1 Hospital Affiliated with Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatric, Fuzhou No. 1 Hospital Affiliated with Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatric, Fuzhou No. 1 Hospital Affiliated with Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qing-Lan', 'Initials': 'QL', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatric, Fuzhou No. 1 Hospital Affiliated with Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Li', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatric, Fuzhou No. 1 Hospital Affiliated with Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatric, Fuzhou No. 1 Hospital Affiliated with Fujian Medical University, Fuzhou, China.'}]","Child: care, health and development",['10.1111/cch.12973']
368,35085837,"Clinical and Patient Reported Outcomes of Pre- and Postsurgical Treatment of Symptomatic Uterine Leiomyomas: A 12-Month Follow-up Review of TRUST, a Surgical Randomized Clinical Trial Comparing Laparoscopic Radiofrequency Ablation and Myomectomy.","STUDY OBJECTIVE


The objective of this study was to determine the efficacy, safety, and healthcare resource use of laparoscopic radiofrequency ablation (LAP-RFA) compared with myomectomy in patients with symptomatic uterine leiomyomas (ULs).
DESIGN


This was a secondary analysis of the original postmarket randomized, multicenter, longitudinal, comparative TRUST (Treatment Results of Uterine Sparing Technologies) United States trial in patients with symptomatic ULs. After the procedure, subjects were followed over a 12-month period.
SETTING


Multicenter trial, including hospitals with or without an academic affiliation, surgery centers, and fertility centers performing outpatient procedures for uterine myomas.
PARTICIPANTS


A total of 57 patients were randomized to either LAP-RFA (n = 30) or myomectomy (n = 27).
INTERVENTIONS


LAP-RFA or myomectomy (laparoscopic or abdominal).
MEASUREMENTS AND MAIN RESULTS


The main outcome measures of this study were part of the secondary outcomes of the original TRUST trial. The primary outcome of this study was the reduction of UL symptoms and the improvement in patient-reported outcomes scores over time. Secondary outcomes included postprocedure hospitalization, length of stay, complications, reinterventions, and recovery time. There was a significant improvement in UL symptoms at 3 and 12 months after the procedure within each treatment group, and these improvements were similar between treatment groups. There was a significant reduction in UL symptoms per month between baseline and 12-months after the procedure for both LAP-RFA and myomectomy of 72% and 85%, respectively. A significant improvement was seen in all patient-reported outcomes scores over time for both groups. At 3 and 12 months after the procedure, the percentages of patients who were hospitalized in the LAP-RFA group were 74% and 49% lower than those of patients in the laparoscopic myomectomy group, respectively, with the 3-month difference being statistically significant. The length of hospital stay was significantly shorter in the LAP-RFA group compared with the myomectomy group (8.0 ± 5.7 hours vs 18.8 ± 14.6 hours; p < .05). Doctors recommended taking significantly less time off before returning to work for the patients in the LAP-RFA group compared with those in the myomectomy group (10.3 ± 5.1 days vs 14.5 ± 5.4 days; p < .05). The total number of days until back to normal activity was significantly lower in the LAP-RFA group compared with the myomectomy group (16.3 ± 15.2 days vs 26.5 ± 15.9 days; p < .05).
CONCLUSION


The results from this 12-month follow-up study suggest that LAP-RFA is a safe, effective, uterine-sparing alternative to laparoscopic myomectomy in the treatment of ULs. These data points build on previously published studies showing that LAP-RFA has lower healthcare resource use overall, including lower postprocedure hospitalization rate and shorter length of stay. In clinical practice, LAP-RFA is a promising treatment approach to ULs for women.",2022,"There was a significant reduction in UL symptoms per month between baseline and 12-months post-procedure for both LAP-RFA and myomectomy of 72% and 85%, respectively.","['114 participants ALLOCATION', 'Multi-center trial, including hospitals with or without an academic affiliation, surgery centers, and fertility centers performing outpatient procedures for uterine fibroids PARTICIPANTS', 'Leiomyomas', 'patients with symptomatic ULs', '57 patients', 'patients with symptomatic uterine leiomyomas (ULs', 'n=30) or myomectomy (n=27', 'Symptomatic Uterine', 'TYPE']","['LAP-RFA or myomectomy (laparoscopic or abdominal', 'LAP-RFA', 'laparoscopic myomectomy', 'https://clinicaltrials.gov/ct2/show/NCT02163525', 'laparoscopic radiofrequency ablation (LAP-RFA', 'Laparoscopic Radiofrequency Ablation (LAP-RFA) and Myomectomy']","['PRO scores', 'reduction of UL symptoms and the improvement in patient reported outcomes (PRO) scores', 'efficacy, safety, and healthcare resource utilization', 'hospitalization post-procedure, length of stay, complications, reinterventions and recovery time', 'UL symptoms', 'total days until back to normal activity', 'length of hospital stay']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1299353', 'cui_str': 'Outpatient procedure'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",57.0,0.198569,"There was a significant reduction in UL symptoms per month between baseline and 12-months post-procedure for both LAP-RFA and myomectomy of 72% and 85%, respectively.","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Hoag Hospital (Dr. Yu), Newport Beach, California.'}, {'ForeName': 'Bala', 'Initials': 'B', 'LastName': 'Bhagavath', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Wisconsin-Madison (Dr. Bhagavath), Madison, Wisconsin.'}, {'ForeName': 'S Abbas', 'Initials': 'SA', 'LastName': 'Shobeiri', 'Affiliation': ""Department of Obstetrics and Gynecology, INOVA Women's Hospital (Dr. Shobeiri), Falls Church, Virginia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eisenstein', 'Affiliation': 'IHA Obstetrics and Gynecology Rochester Hills (Dr. Eisenstein), Rochester Hills, Michigan.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Levy', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences (Dr. Levy), San Diego, California; Department of Obstetrics and Gynecology, George Washington University School of Medicine and Health Sciences (Dr. Levy), Washington, District of Columbia. Electronic address: drbarblevy@gmail.com.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2022.01.009']
369,35074887,"Randomised control trial of a proactive intervention supporting recovery in relation to stress and irregular work hours: effects on sleep, burn-out, fatigue and somatic symptoms.","OBJECTIVES


To examine if a proactive recovery intervention for newly graduated registered nurses (RNs) could prevent the development of sleep problems, burn-out, fatigue or somatic symptoms.
METHODS


The study was a randomised control trial with parallel design. Newly graduated RNs with less than 12 months' work experience were eligible to participate. 461 RNs from 8 hospitals in Sweden were invited, of which 207 signed up. These were randomised to either intervention or control groups. After adjustments, 99 RNs were included in the intervention group (mean age 27.5 years, 84.7% women) and 108 in the control group (mean age 27.0 years, 90.7% women). 82 RNs in the intervention group attended a group-administered recovery programme, involving three group sessions with 2 weeks between each session, focusing on proactive strategies for sleep and recovery in relation to work stress and shift work. Effects on sleep, burn-out, fatigue and somatic symptoms were measured by questionnaires at baseline, postintervention and at 6 months follow-up.
RESULTS


Preventive effect was seen on somatic symptoms for the intervention group. Also, the intervention group showed less burn-out and fatigue symptoms at postintervention. However, these latter effects did not persist at follow-up. Participants used many of the strategies from the programme.
CONCLUSIONS


A proactive, group-administered recovery programme could be helpful in strengthening recovery and preventing negative health consequences for newly graduated RNs.
TRIAL REGISTRATION NUMBER


NCT04246736.",2022,"A proactive, group-administered recovery programme could be helpful in strengthening recovery and preventing negative health consequences for newly graduated RNs.
","['newly graduated registered nurses (RNs', '461 RNs from 8 hospitals in Sweden were invited, of which 207 signed up', ""Newly graduated RNs with less than 12 months' work experience were eligible to participate"", '99 RNs were included in the intervention group (mean age 27.5 years, 84.7% women) and 108 in the control group (mean age 27.0 years, 90.7% women']","['proactive recovery intervention', 'proactive intervention']","['sleep, burn-out, fatigue and somatic symptoms', 'burn-out and fatigue symptoms', 'relation to stress and irregular work hours: effects on sleep, burn-out, fatigue and somatic symptoms', 'somatic symptoms']","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205271', 'cui_str': 'Irregular'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",99.0,0.0769555,"A proactive, group-administered recovery programme could be helpful in strengthening recovery and preventing negative health consequences for newly graduated RNs.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dahlgren', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden anna.dahlgren@ki.se.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Tucker', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Majken', 'Initials': 'M', 'LastName': 'Epstein', 'Affiliation': 'Liljeholmens akademiska vårdcentral/Academic Primary Healthcare Center Liljeholmen, Stockholm, Sweden.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Gustavsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Söderström', 'Affiliation': 'Department of Psychology, Karolinska Institutet Department of Clinical Neuroscience, Stockholm, Sweden.'}]",Occupational and environmental medicine,['10.1136/oemed-2021-107789']
370,35081366,Effect of a Fascial Therapy Treatment on Quality of Life in Patients With Hemophilic Elbow Arthropathy: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the effect of fascial therapy on the perceived quality of life, pain intensity, and joint health in people with hemophilia.
DESIGN


Single-blind randomized controlled trial.
SETTING


Hemophilia Patient Associations.
PARTICIPANTS


Patients with hemophilia (N=69) were randomly allocated to an experimental group (fascial therapy protocol) or to a control group (no intervention whatsoever).
INTERVENTIONS


The fascial therapy intervention lasted 3 consecutive weeks with one 45-minute weekly session.
MAIN OUTCOME MEASURES


The variables evaluated were perceived quality of life (Short Form Health Survey-36), pain intensity (visual analog scale) and joint health (Hemophilia Joint Health Score) at baseline and at 3 and 12 weeks.
RESULTS


The mean values of the physical (38.64±9.41 and 41.92±12.16) and mental (45.77±6.25 and 55.02±9.73) components of the Short Form Health Survey-36 improved after the intervention in the experimental group, as well as those for pain intensity and joint health (P<.001). There were differences (P<.001) in the intergroup effect in the physical role variables (F=49.22), emotional role (F=229.71), mental component (F=9.86), intensity of pain (F=24.74), and joint health (F=55.31).
CONCLUSIONS


A fascial therapy protocol for patients with hemophilic elbow arthropathy can improve their perceived quality of life. Elbow pain intensity improved in patients treated with fascial therapy. This technique can improve elbow joint health.",2022,"There were differences (p < .001) in the intergroup effect in the physical role variables (F = 49.22), emotional role (F = 229.71) and mental component (F = 9.86), and in the intensity of pain (F = 24.74) and the joint health (F = 55.31).
","['people with hemophilia', 'Hemophilia Patient Associations', 'Patients with hemophilia (N\u202f=\u202f69', 'patients with hemophilic elbow arthropathy']","['fascial therapy treatment', 'fascial therapy', 'experimental group (fascial therapy protocol) or to a control group (no intervention whatsoever']","['Elbow pain intensity', 'intensity of pain', 'SF-36', 'mean values of the physical', 'quality of life, pain intensity and joint health', 'quality of life (Short-Form Health Survey-36), pain intensity (Visual Analog Scale) and joint health (Hemophilia Joint health Score', 'elbow joint health', 'pain intensity and joint health', 'joint health', 'quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1997689', 'cui_str': 'Arthropathy of elbow'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0239266', 'cui_str': 'Pain in elbow'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013770', 'cui_str': 'Elbow joint structure'}]",69.0,0.078185,"There were differences (p < .001) in the intergroup effect in the physical role variables (F = 49.22), emotional role (F = 229.71) and mental component (F = 9.86), and in the intensity of pain (F = 24.74) and the joint health (F = 55.31).
","[{'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Cuesta-Barriuso', 'Affiliation': 'Department of Surgery and Medical-Surgical Specialties, University of Oviedo, Oviedo; Royal Victoria Eugenia Foundation, Madrid. Electronic address: cuestaruben@uniovi.es.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Meroño-Gallut', 'Affiliation': 'Tú. Bienestar 360°, Physiotherapy and Medical Center, San Javier, Murcia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Donoso-Úbeda', 'Affiliation': 'Department of Physiotherapy, Catholic University San Antonio-UCAM, Murcia.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'López-Pina', 'Affiliation': 'Department of Basic Phycology and Methodology, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Pérez-Llanes', 'Affiliation': 'Department of Physiotherapy, Catholic University San Antonio-UCAM, Murcia.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.12.023']
371,35084243,Perceptual Responses and Future Exercise Intentions of Individuals With Systemic Arterial Hypertension.,"To analyze the perceptual responses and future intentions (FI) to engage in continuous moderate aerobic exercise (CE) and high-intensity interval exercise (HIIE) of individuals with systemic arterial hypertension (SAH), we had 25 participants with SAH ( M age  = 48.0,  SD  = 8.0 years) perform, on different days and in randomized order, 33 minute sessions of CE and 30 minutes of HIIE. Twenty seconds after each 3-minutes of these sessions, we obtained participant responses to Ratings of Perceived Exertion (RPE), the Feeling Scale (FS), the Felt Arousal Scale (FAS), and attentional focus (AF). We assessed their FI to engage in CE and HIIE at the end of each session. We analyzed results using two-way ANOVAs with repeated measures, Spearman correlation coefficients, a simple linear regression, and Wilcoxon test. We found a significant time by session type (CE and HIIE) interaction effect for RPE ( p  < .001), FAS ( p  = .002), and AF ( p  = .004). Participants' FI to engage in HIIE were only significantly correlated with FAS ( r  = -.424;  p  = .035) and AF ( r  = .431 ; p  = .032) responses. FAS responses (βz = -.455; R 2  = .207 ; p  = .022) and AF responses (βz = .467; R 2  = .218;  p  = .019) predicted FI for engaging in HIIE. There were no significant differences in participants' FI to engage in CE sessions ( M  = 76.4,  SD  =22.5%) versus HIIE sessions ( M  = 71.8,  SD  = 22.9%;  p  = .177). Individuals with SAH had more positive perceptions of CE than HIIE, as seen by their greater dissociative AF in the CE sessions. Furthermore, these results supported the application of strategies aimed at manipulating AF in this population, possibly as a tool to increase participants' FI to engage in subsequent physical exercise.",2022,"We found a significant time by session type (CE and HIIE) interaction effect for RPE (F [2.05; 49.17] = 3.31; p < 0.001), FAS (F [2.43; 58.25] = 6.18; p = 0.002) and AF (F [2.56; 61.44] =","['Individuals with Systemic Arterial Hypertension', 'individuals with systemic arterial hypertension (SAH), we had 25 participants with SAH (M age=48.0, SD=8.0 years']",['continuous moderate aerobic exercise (CE) and high-intensity interval exercise (HIIE'],"['FAS responses', 'FAS', 'AF responses', 'Perceptual Responses and Future Exercise Intentions', 'Ratings of Perceived Exertion (RPE), the Feeling Scale (FS), the Felt Arousal Scale (FAS), and attentional focus (AF', ""participants' FI to engage in CE sessions"", 'significant time by session type (CE and HIIE) interaction effect for RPE']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",25.0,0.0300265,"We found a significant time by session type (CE and HIIE) interaction effect for RPE (F [2.05; 49.17] = 3.31; p < 0.001), FAS (F [2.43; 58.25] = 6.18; p = 0.002) and AF (F [2.56; 61.44] =","[{'ForeName': 'Mirelle Vieira', 'Initials': 'MV', 'LastName': 'Moreira', 'Affiliation': 'Graduate Program of Health and Biological Science, 74373Federal University of Vale do São Francisco - UNIVASF, Petrolina, Brazil.'}, {'ForeName': 'Victor Ribeiro', 'Initials': 'VR', 'LastName': 'Neves', 'Affiliation': 'Graduate Program in Rehabilitation and Functional Performance, 117110Pernambuco University - UPE, Petrolina, Brazil.'}, {'ForeName': 'Paulo Adriano', 'Initials': 'PA', 'LastName': 'Schwingel', 'Affiliation': 'Graduate Program in Rehabilitation and Functional Performance, 117110Pernambuco University - UPE, Petrolina, Brazil.'}, {'ForeName': 'Sergio Rodrigues', 'Initials': 'SR', 'LastName': 'Moreira', 'Affiliation': 'Graduate Program of Health and Biological Science, 74373Federal University of Vale do São Francisco - UNIVASF, Petrolina, Brazil.'}]",Perceptual and motor skills,['10.1177/00315125211073280']
372,34964250,Postdialysis serum phosphate equilibrium in hemodialysis patients on a controlled diet and no binders.,"BACKGROUND


Studies evaluating the change in serum phosphate post hemodialysis (HD) demonstrate an initial decline during dialysis but a rebound post dialysis. However, previous studies were done on usual diet and phosphate binders, with limited number of blood draws, confounding conclusions. We determined serum phosphate reduction, rebound, and equilibrium over 48 h in HD patients consuming a controlled, low phosphorus diet without binders.
METHODS


Serum phosphate (mg/dL) was analyzed before and after a HD treatment and frequently during the ensuing 48 h intradialytic period in the clinical research unit. Thirteen subjects were enrolled and had been off phosphate binders for 10 days and consumed a standardized low phosphate (900 mg/day) diet for 3 weeks prior to the assessments. Linear regression was used to determine relationships between the pre-HD serum phosphate, decline post-HD (post-HD drop); and a 48 h area under curve (AUC) using the trapezoidal method as a measure of overall phosphate levels from the end of dialysis to 48 h post dialysis. Repeated Measures ANOVA with Dunnett's posthoc test was used to determine rebound.
RESULTS


Five of 13 subjects returned to >90% of their pre-HD serum phosphate within the first 24 h post-HD, and serum phosphate was 94 ± 0.11% (range 63%-113%) by 48 h after the completion of HD. The 48 h AUC of serum phosphate during the interdialytic period was correlated with both pre dialysis phosphorus (r = 0.85; p = 0.0002) and the pre-post drop in serum phosphate during dialysis (r = 0.69; p = 0.0085). In contrast, the net ultrafiltration was not related to the 48 h AUC of serum phosphorus (r = 0.20; p = 0.51).
CONCLUSIONS


In hemodialysis patients on standard low phosphorus diet and no phosphate binders, the interdialytic serum phosphorus level, assessed as AUC, is determined by the pre dialysis phosphorus and net-change in serum phosphorus during the dialysis treatment, but not the ultrafiltration volume [Correction added on 25 January, after first online publication: In the last sentence of the Abstract, the word ""potassium"" has been replaced with ""phosphorus"" to improve accuracy.].",2022,"In contrast, the net ultrafiltration was not related to the 48 h AUC of serum phosphorus (r = 0.20; p = 0.51).
","['Thirteen subjects were enrolled and had been off phosphate binders for 10\u2009days and consumed a', 'hemodialysis patients']","['standard low phosphorus diet and no phosphate binders', 'standardized low phosphate']","['Postdialysis serum phosphate equilibrium', 'net ultrafiltration', 'serum phosphate']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452351', 'cui_str': 'Low phosphate diet'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0860987', 'cui_str': 'Phosphate low'}]","[{'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}]",13.0,0.00357266,"In contrast, the net ultrafiltration was not related to the 48 h AUC of serum phosphorus (r = 0.20; p = 0.51).
","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Stremke', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Trevino', 'Affiliation': 'Indiana Clinical and Translational Science Institute, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Simit', 'Initials': 'S', 'LastName': 'Doshi', 'Affiliation': 'Department of Medicine/Division of Nephrology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ranjani N', 'Initials': 'RN', 'LastName': 'Moorthi', 'Affiliation': 'Department of Medicine/Division of Nephrology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hill Gallant', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana, USA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Moe', 'Affiliation': 'Indiana Clinical and Translational Science Institute, Indiana University, Indianapolis, Indiana, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12999']
373,35081255,Follow-up of patients with R/R FLT3-mutation-positive AML treated with gilteritinib in the phase 3 ADMIRAL trial.,"The phase 3 ADMIRAL (NCT02421939; Study ID: 2215-CL-0301) trial showed superior overall survival in patients with relapsed/refractory FLT3-mutation-positive acute myeloid leukemia (AML) randomized 2:1 to receive the oral FMS-like tyrosine kinase 3 inhibitor gilteritinib vs those randomized to receive salvage chemotherapy (SC). Here we provide a follow-up of the ADMIRAL trial 2 years after the primary analysis to clarify the long-term treatment effects and safety of gilteritinib in these patients with AML. At the time of this analysis, the median survival follow-up was 37.1 months, with deaths in 203 of 247 and 97 of 124 patients in the gilteritinib and SC arms, respectively; 16 gilteritinib-treated patients remained on treatment. The median overall survival for the gilteritinib and SC arms was 9.3 and 5.6 months, respectively (hazard ratio, 0.665; 95% confidence interval [CI], 0.518, 0.853; two-sided P = .0013); 2-year estimated survival rates were 20.6% (95% CI, 15.8, 26.0) and 14.2% (95% CI, 8.3, 21.6). The gilteritinib-arm 2-year cumulative incidence of relapse after composite complete remission was 75.7%, with few relapses occurring after 18 months. Overall, 49 of 247 patients in the gilteritinib arm and 14 of 124 patients in the SC arm were alive for ≥2 years. Twenty-six gilteritinib-treated patients remained alive for ≥2 years without relapse; 18 of these patients underwent transplantation (hematopoietic stem cell transplantation [HSCT]) and 16 restarted gilteritinib as post-HSCT maintenance therapy. The most common adverse events of interest during years 1 and 2 of gilteritinib therapy were increased liver transaminase levels; adverse event incidence decreased in year 2. Thus, continued and post-HSCT gilteritinib maintenance treatment sustained remission with a stable safety profile. These findings confirm that prolonged gilteritinib therapy is safe and is associated with superior survival vs SC. This trial was registered at www.clinicaltrials.gov as #NCT02421939.",2022,Most common adverse events (AEs) of interest during Years 1 and 2 of gilteritinib therapy were increased liver transaminases; AE incidence decreased in Year 2.,"['relapsed/refractory FLT3-mutation-positive acute myeloid leukemia patients', '49/247 patients in the gilteritinib arm and 14/124 patients in the SC arm were alive for ≥2 years']","['salvage chemotherapy (SC', 'HSCT maintenance therapy', 'transplantation (HSCT', 'oral FLT3 inhibitor, gilteritinib']","['superior overall survival (OS', 'liver transaminases; AE incidence', 'median OS', '2-year estimated survival rates', 'median survival']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3896940', 'cui_str': 'gilteritinib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3896940', 'cui_str': 'gilteritinib'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.229125,Most common adverse events (AEs) of interest during Years 1 and 2 of gilteritinib therapy were increased liver transaminases; AE incidence decreased in Year 2.,"[{'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Perl', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Nikolai A', 'Initials': 'NA', 'LastName': 'Podoltsev', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Strickland', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Eunice S', 'Initials': 'ES', 'LastName': 'Wang', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Atallah', 'Affiliation': 'Division of Hematology and Oncology, Medical College of Wisconsin, Cancer Center-Froedtert Hospital, Milwaukee, WI.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Schiller', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinelli', 'Affiliation': 'IRCCS Istituto Romagnolo per lo Studio dei Tumori ""Dino Amadori,"" IRST S.r.l., Meldola, Italy.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'Universitätsklinikum Giessen und Marburg GmbH, Marburg, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sierra', 'Affiliation': 'Hospital de la Santa Creu I Sant Pau and Josep Carreras Leukemia Research Institute, Barcelona, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'University Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Récher', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer deToulouse Oncopole, Université de Toulouse 3 Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Hosono', 'Affiliation': 'University of Fukui, Fukui, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Onozawa', 'Affiliation': 'Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Chiba', 'Affiliation': 'Department of Hematology, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hee-Je', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Catholic Hematology Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Hasabou', 'Affiliation': 'Astellas Pharma US, Inc., Northbrook, IL; and.'}, {'ForeName': 'Qiaoyang', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Astellas Pharma US, Inc., Northbrook, IL; and.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Tiu', 'Affiliation': 'Astellas Pharma US, Inc., Northbrook, IL; and.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Levis', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD.'}]",Blood,['10.1182/blood.2021011583']
374,35088708,Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial.,"STUDY OBJECTIVES


It has been suggested that treatment for obstructive sleep apnea (OSA) reduces cardiovascular risk. So far, knowledge is limited about the difference in the reduction of this risk between mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy. The aim of this study was to compare the cardiovascular effects of MAD vs CPAP therapy in patients with moderate OSA.
METHODS


Patients with an apnea-hypopnea index of 15-30 events/h were randomized to either MAD or CPAP therapy. At baseline and after 12-month follow-up, 24-hour ambulant blood pressure measurements and laboratory measurements were performed. Ambulant blood pressure measurements consisted of 24-hour, daytime and night-time systolic and diastolic blood pressure and heart rate measurements. Laboratory measurements consisted of serum lipid values, creatinine, high-sensitivity C-reactive protein, plasma glucose, hemoglobin A1c glycated hemoglobin, proinflammatory cytokines, soluble receptor for advanced glycation end-products, chemokines, and adhesion molecules.
RESULTS


Of the 85 randomized patients with moderate OSA, data were available for 54 patients (n = 24 MAD, n = 30 CPAP) at 12-month follow-up and showed that apnea-hypopnea index significantly decreased with either therapy. In the MAD group, soluble receptor for advanced glycation end-products and glycated hemoglobin were significantly higher after 12 months' follow-up compared to baseline. No significant changes were found between MAD and CPAP treatments for all outcomes.
CONCLUSIONS


Treatment of patients with moderate OSA with either MAD or CPAP therapy had no profound effects on major cardiovascular risk factors after 12 months.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: MRA Therapy vs CPAP Therapy in Moderate OSAS; Identifier: NCT01588275; URL: https://clinicaltrials.gov/ct2/show/NCT01588275.
CITATION


Uniken Venema JAM, Knol-de Vries GE, van Goor H, Westra J, Hoekema A, Wijkstra PJ. Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial.  J Clin Sleep Med . 2022;18(6)1547-1555.",2022,"In the MAD group, sRAGE and HbA1c were significantly higher after 12 months follow-up compared to baseline.","['moderate obstructive sleep apnea', 'patients with moderate OSA with either MAD or', '85 randomized patients with moderate OSA', 'patients with moderate OSA', '54 patients (n=24 MAD, n=30 CPAP', 'Patients with an apnea-hypopnea index (AHI) of 15-30 events/h']","['CPAP therapy', 'MAD or CPAP therapy', 'MAD versus CPAP therapy', 'mandibular advancement device and continuous positive airway pressure']","['sRAGE and HbA1c', '24-hour ambulant blood pressure measurements (ABPM) and laboratory measurements', 'serum lipid values, creatinine, high-sensitivity c-reactive protein, plasma glucose, hemoglobin A1c (HbA1c), proinflammatory cytokines, soluble receptor for advanced glycation end products (sRAGE), chemokines and adhesion molecules', 'major cardiovascular risk factors', 'ABPM consisted of 24-hour, daytime and night-time systolic (SBP) and diastolic blood pressure (DBP), and heart rate (HR) measurements', 'Cardiovascular and metabolic effects']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}]","[{'cui': 'C0101725', 'cui_str': 'Receptor for Advanced Glycation Endproducts'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",85.0,0.0420645,"In the MAD group, sRAGE and HbA1c were significantly higher after 12 months follow-up compared to baseline.","[{'ForeName': 'Julia A M', 'Initials': 'JAM', 'LastName': 'Uniken Venema', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Grietje E', 'Initials': 'GE', 'LastName': 'Knol-de Vries', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': 'Department of Pathology and Medical Biology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Westra', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Aarnoud', 'Initials': 'A', 'LastName': 'Hoekema', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9908']
375,35090887,Electrical Dry Needling Plus Corticosteroid Injection for Osteoarthritis of the Knee: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effects of electrical dry needling (DN) plus corticosteroid injection (CSI) on pain, physical function, and global change in patients with osteoarthritis of the knee (KOA).
DESIGN


A prospective, single-blinded, randomized controlled trial.
SETTING


Pain treatment clinic.
PARTICIPANTS


Sixty patients with KOA were randomly assigned to the electrical dry needling plus corticosteroid injection (electrical-DN+CSI) group or CSI group.
INTERVENTIONS


The CSI group received glucocorticoid injection only once during the trial, and the electrical-DN+CSI group received glucocorticoid injection combined with 4 sessions of electrical-DN.
MAIN OUTCOMES MEASURES


The primary outcome was the numerical rating scale at 3 months. The secondary outcomes were the Western Ontario and McMaster Universities Osteoarthritis Index, the time to complete the Timed Up and Go test, and the score of the global rating of change scale at 3 months. A generalized linear mixed-effects model was used to analyze the repeated measurement data.
RESULTS


Baseline characteristics and measurements were similar in the 2 groups. The group by time interaction effect was significant for all variables (P<.05). The electrical-DN+CSI group obtained a more significant reduction in pain intensity and more significant improvement in dysfunction than the CSI group at 3 months (P<.05). The median global rating of change score for the CSI group was +3 (somewhat better), and that for the electrical-DN+CSI group was +4 (moderately better).
CONCLUSION


Electrical-DN therapy at myofascial trigger points combined with CSI is more effective at alleviating pain, improving dysfunction, and creating global change than CSI alone for patients with KOA. Electrical-DN may be an essential part of treatment for KOA rehabilitation.",2022,"Electrical-DN therapy at myofascial trigger points combined with CSI is more effective at alleviating pain, improving dysfunction, and global change than CSI alone for patients with KOA.","['Pain treatment clinic', 'patients with KOA', 'Sixty patients with KOA', 'patients with osteoarthritis of the knee (KOA', 'Osteoarthritis of the Knee']","['glucocorticoid injection', 'Electrical Dry Needling Plus Corticosteroid Injection', 'CSI', 'Electrical-DN therapy', 'electrical dry needling plus corticosteroid injection (electrical-DN+CSI) group or CSI group', 'glucocorticoid injection combined with 4 sessions of electrical-DN', 'electrical dry needling (DN) plus corticosteroid injection (CSI']","['GROC) scale', 'dysfunction', 'Western Ontario and McMaster Universities Osteoarthritis Index, the time to complete the Timed Up and Go test, and the score of the Global Rating of Change', 'numerical rating scale', 'pain, physical function, and global change', 'median GROC score', 'pain, improving dysfunction, and global change', 'pain intensity']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",60.0,0.0837154,"Electrical-DN therapy at myofascial trigger points combined with CSI is more effective at alleviating pain, improving dysfunction, and global change than CSI alone for patients with KOA.","[{'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'College of Anesthesiology, Xuzhou Medical University, Xuzhou City, Jiangsu Province.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'College of Anesthesiology, Xuzhou Medical University, Xuzhou City, Jiangsu Province.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'College of Anesthesiology, Xuzhou Medical University, Xuzhou City, Jiangsu Province.'}, {'ForeName': 'Yanru', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'College of Anesthesiology, Xuzhou Medical University, Xuzhou City, Jiangsu Province.'}, {'ForeName': 'Qinge', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'College of Anesthesiology, Xuzhou Medical University, Xuzhou City, Jiangsu Province.'}, {'ForeName': 'Lixue', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'College of Anesthesiology, Xuzhou Medical University, Xuzhou City, Jiangsu Province.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Pain Treatment, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province, China. Electronic address: yuanyan43210@outlook.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.12.026']
376,35091853,"The effectiveness of workplace health promotion program in reducing work-related depression, anxiety and stress among manufacturing workers in Malaysia: mixed-model intervention.","INTRODUCTION


The implications of work-related stress among manufacturing workers were often unrecognised. The purpose of this study is to determine the effectiveness of the workplace health promotion (WHP) program in reducing depression, anxiety, and stress levels, as well as improving the overall quality of life among Malaysian manufacturing workers.
METHODS


The study used a randomised controlled trial (RCT) design and included 88 employees from a food and beverage manufacturing factory in Klang Valley, Malaysia. The intervention group received a comprehensive WHP program based on organisational and individual stress management programs that included (i) healthy mental health module, (ii) anxiety management technique, (iii) mindfulness for stress and (iv) stress at work. The module was delivered through the Occupational Stress Management Course and Employee Assistance Program. The control group received no further intervention other than a general brochure on stress. The study period consisted of an intervention period of 3 months followed by a post-intervention period of 3 months. Measurements were recorded at baseline and at 3 month post-intervention. Outcome measures included the self-perceived depression, anxiety, and stress (DASS-21), participant's quality of life (WHOQOL), coping skills (COPE-28) and job characteristics (JCQ).
RESULTS


The intervention group demonstrated a significant reduction in self-perceived stress, anxiety, and depression scores three months post intervention (p ≤ 0.001). All domains of health-related quality of life and coping skills related to social support and problem-solving were significantly improved in the intervention group following the intervention (p < 0.001). In the control group, no significant changes were observed in all the parameters.
CONCLUSION


WHP program shows promising results in improving mental health status, quality of life and coping skills among the manufacturing workers.",2022,All domains of health-related quality of life and coping skills related to social support and problem-solving were significantly improved in the intervention group following the intervention (p < 0.001).,"['manufacturing workers in Malaysia', '88 employees from a food and beverage manufacturing factory in Klang Valley, Malaysia']","['workplace health promotion program', 'workplace health promotion (WHP) program', 'WHP program', 'comprehensive WHP program based on organisational and individual stress management programs that included (i) healthy mental health module, (ii) anxiety management technique, (iii) mindfulness for stress and (iv) stress at work']","['depression, anxiety, and stress levels', 'self-perceived stress, anxiety, and depression scores', 'overall quality of life', 'mental health status, quality of life and coping skills', ""self-perceived depression, anxiety, and stress (DASS-21), participant's quality of life (WHOQOL), coping skills (COPE-28) and job characteristics (JCQ"", 'health-related quality of life and coping skills related to social support and problem-solving']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0442614', 'cui_str': 'Factory'}, {'cui': 'C0563004', 'cui_str': 'Valley'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0558919', 'cui_str': 'Stress at work'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0022396', 'cui_str': 'Position Description'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",88.0,0.00412308,All domains of health-related quality of life and coping skills related to social support and problem-solving were significantly improved in the intervention group following the intervention (p < 0.001).,"[{'ForeName': 'Ahmad Fairuz', 'Initials': 'AF', 'LastName': 'Mohamed', 'Affiliation': 'School of Graduate Studies, Management and Science University, University Drive, Off Persiaran Olahraga, 40100, Shah Alam, Selangor, Malaysia. drfairuz.edu@gmail.com.'}, {'ForeName': 'Marzuki', 'Initials': 'M', 'LastName': 'Isahak', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohd Zaki', 'Initials': 'MZ', 'LastName': 'Awg Isa', 'Affiliation': 'MSU Centre of Excellence for Vision and Eyecare (MSU-iCARE), Management and Science University, University Drive, Off Persiaran Olahraga, Section 13, Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Rusli', 'Initials': 'R', 'LastName': 'Nordin', 'Affiliation': 'Faculty of Medicine, Bioscience and Nursing, MAHSA University, Jalan SP2, Bandar Saujana Putra, 42610, Jenjarom, Selangor, Malaysia.'}]",International archives of occupational and environmental health,['10.1007/s00420-022-01836-w']
377,35091443,ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non-Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges.,"PURPOSE


Central nervous system metastases are a prominent cause of morbidity and mortality in patients with ALK-positive (ALK+) non-small cell lung cancer (NSCLC). The phase II ASCEND-7 (NCT02336451) study was specifically designed to assess the efficacy and safety of the ALK inhibitor (ALKi) ceritinib in patients with ALK+ NSCLC metastatic to the brain and/or leptomeninges.
PATIENTS AND METHODS


Patients with active brain metastases were allocated to study arms 1 to 4 based on prior exposure to an ALKi and/or prior brain radiation (arm 1: prior radiotherapy/ALKi-pretreated; arm 2: no radiotherapy/ALKi-pretreated; arm 3: prior radiotherapy/ALKi-naïve; arm 4: no radiotherapy/ALKi-naïve). Arm 5 included patients with leptomeningeal carcinomatosis. Patients received ceritinib 750 mg once daily (fasted condition). Primary endpoint was investigator-assessed whole-body overall response rate (ORR) per RECIST v1.1. Secondary endpoints included disease control rate (DCR) and intracranial/extracranial responses.
RESULTS


Per investigator assessment, in arms 1 (n = 42), 2 (n = 40), 3 (n = 12), and 4 (n = 44), respectively: whole-body ORRs [95% confidence interval (CI)] were 35.7% (21.6-52.0), 30.0% (16.6-46.5), 50.0% (21.1-78.9), and 59.1% (43.2-73.7); whole-body DCR (95% CI): 66.7% (50.5-80.4), 82.5% (67.2-92.7), 66.7% (34.9-90.1), and 70.5% (54.8-83.2); intracranial ORRs (95% CI): 39.3% (21.5-59.4), 27.6% (12.7-47.2), 28.6% (3.7-71.0), and 51.5% (33.5-69.2). In arm 5 (n = 18), whole-body ORR was 16.7% (95% CI, 3.6-41.4) and DCR was 66.7% (95% CI, 41.0-86.7). Paired cerebrospinal fluid and plasma sampling revealed that ceritinib penetrated the human blood-brain barrier.
CONCLUSIONS


Ceritinib showed antitumor activity in patients with ALK+ NSCLC with active brain metastases and/or leptomeningeal disease, and could be considered in the management of intracranial disease. See related commentary by Murciano-Goroff et al., p. 2477.",2022,"In arm 5 (n=18), whole-body ORR was 16.7% (95% CI, 3.6-41.4) and DCR was 66.7% (95% CI, 41.0-86.7).","['patients with leptomeningeal carcinomatosis', 'patients with  ALK+  NSCLC with active brain metastases and/or leptomeningeal disease', 'patients with  ALK + NSCLC metastatic to the brain and/or leptomeninges', 'patients with  ALK -positive', 'Patients with active brain metastases', 'Patients With  ALK -Positive Non']","['ALKi and/or prior brain radiation (arm 1: prior radiotherapy/ALKi-pretreated; arm 2: no radiotherapy/ALKi-pretreated; arm 3: prior radiotherapy/ALKi-naive; arm 4: no radiotherapy/ALKi-naive', 'Ceritinib Treatment', 'ceritinib 750 mg once daily (fasted condition', 'ASCEND-7']","['efficacy and safety of ALK inhibitor (ALKi) ceritinib', 'disease control rate (DCR) and intracranial/extracranial responses', 'body ORRs', 'whole-body ORR', 'DCR', 'investigator-assessed whole-body overall response rate (ORR', 'antitumor activity', 'intracranial ORRs', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220654', 'cui_str': 'Malignant meningitis'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0751297', 'cui_str': 'Neoplasms, Leptomeningeal'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0228126', 'cui_str': 'Leptomeninges structure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3818721', 'cui_str': 'ceritinib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3818721', 'cui_str': 'ceritinib'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.161996,"In arm 5 (n=18), whole-body ORR was 16.7% (95% CI, 3.6-41.4) and DCR was 66.7% (95% CI, 41.0-86.7).","[{'ForeName': 'Laura Q M', 'Initials': 'LQM', 'LastName': 'Chow', 'Affiliation': 'University of Washington, Seattle, Washington and University of Texas at Austin, Dell Medical School, Department of Oncology, Austin, Texas.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Aix-Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Bertino', 'Affiliation': 'The Ohio State University Comprehensive Cancer Centre, Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, Ohio.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neurology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Wakelee', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Chao-Hua', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Orlov', 'Affiliation': 'State Pavlov Medical University, St. Petersburg, Russia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Chiari', 'Affiliation': 'Department of Oncology, AULSS6 Euganea, Padova, Italy.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de La Santa Creu I Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McKeage', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Chong-Jen', 'Initials': 'CJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Garrido', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Ramon Y Cajal, Madrid, Spain.'}, {'ForeName': 'Felipe K', 'Initials': 'FK', 'LastName': 'Hurtado', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Pilar Cazorla', 'Initials': 'PC', 'LastName': 'Arratia', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yuanbo', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Branle', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-1838']
378,35091859,Intraoperative Tumor Identification During Laparoscopic Distal Gastrectomy: a Novel Fluorescent Clip Marking Versus Metal Clip Marking and Intraoperative Gastroscope.,"BACKGROUND


In complete laparoscopic distal gastrectomy, the gastric resection line is difficult to determine due to a lack of tactile sensation. The use of intraoperative gastroscopy and intraoperative radiography has been reported, but the burden on personnel and technical complexity present impediments. In our department, based on lesion extent determined with preoperative gastroscopy, a fluorescent clip is used to mark the oral side of the lesion, which is resected after confirmation with a fluorescent laparoscopic system. In this study, we investigated the efficacy of fluorescent clip marking (FCM) in achieving an accurate resection line and reducing the operative time.
METHODS


Fifty-six patients with gastric cancer who underwent complete laparoscopic distal gastrectomy from January 2018 to March 2021 were divided into two groups: the FCM group (n = 32) and the conventional metal clip marking and intraoperative gastroscopy (MCMG) group (n = 24). Short-term outcomes, including the resection margins, gastric resection time, and operative time, were compared and examined.
RESULTS


The fluorescent clips were visible in all cases, and all stumps were negative according to permanent preparations. The operative times for FCM and MCMG were 350 (216-533) vs. 373.5 (258-651) min, respectively, with no significant difference (p = 0.316), while the gastric resection times were 636.5 (321-2572) vs. 1457.5 (843-4973) s, respectively, and were significantly shorter in the FCM group (p < 0.0001).
CONCLUSIONS


FCM shortened the gastric resection time and could possibly shorten the operative time. FCM is feasible and safe and can potentially be used as a tumor-marking agent to determine accurate surgical resection lines.
CLINICAL TRIAL REGISTRATION


Examination of Gastric Cancer, Research Ethics Committee of the Kawaguchi Municipal Medical Centre (Saitama, Japan), approval number: 2019-33. https://kawaguchi-mmc.org/wp-content/uploads/clinicalresearch-r02.pdf.",2022,"The operative times for FCM and MCMG were 350 (216-533) vs. 373.5 (258-651) min, respectively, with no significant difference (p = 0.316), while the gastric resection times were 636.5 (321-2572) vs. 1457.5 (843-4973) s, respectively, and were significantly shorter in the FCM group (p < 0.0001).
",['Fifty-six patients with gastric cancer who underwent complete laparoscopic distal gastrectomy from January 2018 to March 2021'],"['conventional metal clip marking and intraoperative gastroscopy (MCMG', 'Fluorescent Clip Marking Versus Metal Clip Marking and Intraoperative Gastroscope', 'fluorescent clip marking (FCM', 'intraoperative gastroscopy and intraoperative radiography', 'FCM', 'Laparoscopic Distal Gastrectomy']","['resection margins, gastric resection time, and operative time', 'Intraoperative Tumor Identification', 'gastric resection times', 'operative time', 'gastric resection time', 'operative times for FCM and MCMG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0192468', 'cui_str': 'Transabdominal gastroscopy'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0181020', 'cui_str': 'Gastroscope'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}]","[{'cui': 'C0229985', 'cui_str': 'Surgical margins'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0192468', 'cui_str': 'Transabdominal gastroscopy'}]",56.0,0.0912572,"The operative times for FCM and MCMG were 350 (216-533) vs. 373.5 (258-651) min, respectively, with no significant difference (p = 0.316), while the gastric resection times were 636.5 (321-2572) vs. 1457.5 (843-4973) s, respectively, and were significantly shorter in the FCM group (p < 0.0001).
","[{'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Department of Digestive Surgery, Kawaguchi Municipal Medical Centre, Kawaguchi City, Saitama, Nishiaraijuku, 180333-0833, Japan.'}, {'ForeName': 'Shunjin', 'Initials': 'S', 'LastName': 'Ryu', 'Affiliation': 'Department of Digestive Surgery, Kawaguchi Municipal Medical Centre, Kawaguchi City, Saitama, Nishiaraijuku, 180333-0833, Japan. systematic.ryu1121@gmail.com.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Digestive Surgery, Kawaguchi Municipal Medical Centre, Kawaguchi City, Saitama, Nishiaraijuku, 180333-0833, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Digestive Surgery, Kawaguchi Municipal Medical Centre, Kawaguchi City, Saitama, Nishiaraijuku, 180333-0833, Japan.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Marukuchi', 'Affiliation': 'Department of Digestive Surgery, Kawaguchi Municipal Medical Centre, Kawaguchi City, Saitama, Nishiaraijuku, 180333-0833, Japan.'}, {'ForeName': 'Ryusuke', 'Initials': 'R', 'LastName': 'Ito', 'Affiliation': 'Department of Digestive Surgery, Kawaguchi Municipal Medical Centre, Kawaguchi City, Saitama, Nishiaraijuku, 180333-0833, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Nakabayashi', 'Affiliation': 'Department of Digestive Surgery, Kawaguchi Municipal Medical Centre, Kawaguchi City, Saitama, Nishiaraijuku, 180333-0833, Japan.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-021-05208-6']
379,35092072,Improving the fitness of the NASH clinical trial: Standardizing the standard-of-care intervention.,,2022,,[],[],[],[],[],[],,0.231675,,"[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Kappus', 'Affiliation': 'Division of Gastroenterology and Hepatology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Yuval A', 'Initials': 'YA', 'LastName': 'Patel', 'Affiliation': 'Division of Gastroenterology and Hepatology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Duarte-Rojo', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.32369']
380,35092016,Program for the Education and Enrichment of Relational Skills for adolescents with an acquired brain injury: A randomized controlled trial.,"AIM


To test the efficacy of a group social skills intervention on social functioning in adolescents with a brain injury.
METHOD


Thirty-six adolescents (mean age 14y, SD 1y 8mo, age range 12y 1mo-16y 3mo; 17 females) with acquired brain injury (ABI; ≥12mo postintervention; n=19) or cerebral palsy (n=17) were randomly allocated to the Program for the Education in Enrichment of Relational Skills (PEERS) or usual care. The primary outcome was the Social Skills Improvement System-Rating Scales (SSIS-RS). Secondary outcomes were scores derived from the Test of Adolescent Social Skills Knowledge-Revised (TASSK-R), Social Responsiveness Scale, Second Edition, and Quality of Socialization Questionnaire. Between-group differences postintervention and at the 26-week retention time point were compared using linear mixed modelling for continuous outcomes and Poisson regression for count data.
RESULTS


There were no between-group differences on the primary outcome (SSIS-RS). Regarding the secondary outcomes, the PEERS-exposed group achieved significantly greater improvements on the TASSK-R (mean difference [MD]=6.8, 95% confidence interval [CI]=4.8-8.8, p<0.001), which were maintained at the 26-week retention time point (MD=8.1, 95% CI=6.0-10.2, p<0.001). PEERS was also associated with a significant increase in parent-reported invited get-togethers at 26 weeks (incidence rate ratio=4.0, 95% CI=1.0-16.0, p=0.05).
INTERPRETATION


Adolescents with brain injury who completed the PEERS learned and retained social knowledge and increased social participation.",2022,"PEERS was also associated with a significant increase in parent-reported invited get-togethers at 26 weeks (incidence rate ratio=4.0, 95% CI=1.0-16.0, p=0.05).
","['adolescents with an acquired brain injury', 'adolescents with a brain injury', 'Adolescents with brain injury who completed the PEERS learned and retained social knowledge and increased social participation', 'Thirty-six adolescents (mean age 14y, SD 1y 8mo, age range 12y 1mo-16y 3mo; 17 females) with acquired brain injury (ABI; ≥12mo postintervention; n=19) or cerebral palsy (n=17']","['Program for the Education in Enrichment of Relational Skills (PEERS) or usual care', 'social skills intervention']","['Social Skills Improvement System-Rating Scales (SSIS-RS', 'scores derived from the Test of Adolescent Social Skills Knowledge-Revised (TASSK-R), Social Responsiveness Scale, Second Edition, and Quality of Socialization Questionnaire', 'TASSK-R', 'social functioning']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",17.0,0.135279,"PEERS was also associated with a significant increase in parent-reported invited get-togethers at 26 weeks (incidence rate ratio=4.0, 95% CI=1.0-16.0, p=0.05).
","[{'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Gilmore', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ziviani', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mcintyre', 'Affiliation': 'Cerebral Palsy Alliance Research Institute, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Smithers Sheedy', 'Affiliation': 'Cerebral Palsy Alliance Research Institute, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Hilton', 'Affiliation': ""Queensland Paediatric Rehabilitation Service, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': ""Kids Rehab, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.""}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Laugeson', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Sakzewski', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Developmental medicine and child neurology,['10.1111/dmcn.15144']
381,35090365,Kindergarten-Based Progressive Muscle Relaxation Training Enhances Attention and Executive Functioning: A Randomized Controlled Trial.,"In the present study, we assessed the impact of kindergarten-based progressive muscle relaxation (PMR) on attention and executive functioning of 5-6-year-old children. In this randomized-controlled trial, 52 children (26 female; 26 male;  M  age = 5.4,  SD  = 0.2 years) from two private Tunisian kindergartens were randomly assigned to experimental and control groups. Over 12 weeks, 18 children performed PMR in two 30-minute sessions/week, another 17 children performed generic physical education (PE) for two 30-minute sessions/week, and 17 children in a control group (CG) had no systematically guided physical activity and engaged in usual self-chosen activities like free play or artisanal activities during kindergarten hours. Prior to (T 0 ) and after (T 1 ) the 12-week PMR intervention, all participants completed the Visuomotor Precision and Statue subtests of the Neuropsychological Evaluation Battery (NEPSY-2), the Teddy Bear Cancellation Test, and the Rey Simple Figure Test. Although there were no significant group differences at T 0 , repeated measures analysis of variance revealed higher scores for the PMR group relative to both the PE and CG groups on measures of attention, visuomotor precision, memory, and motor inhibition. PMR provided an effective relaxation technique and enhanced attention and executive functioning of these 5-6-year-old children, with important implications for assisting learning and academic achievement among young children.",2022,"PMR provided an effective relaxation technique and enhanced attention and executive functioning of these 5-6-year-old children, with important implications for assisting learning and academic achievement among young children.","['young children', '52 children (26 female; 26 male; M age = 5.4, SD = 0.2 years) from two private Tunisian kindergartens', '5-6-year-old Children', '5-6-year-old children']","['kindergarten-based progressive muscle relaxation (PMR', 'generic physical education (PE', 'PMR', 'Kindergarten-Based Progressive Muscle Relaxation Training Enhances Attention and Executive Functioning', 'control group (CG) had no systematically guided physical activity and engaged in usual self-chosen activities like free play or artisanal activities']","['attention, visuomotor precision, memory, and motor inhibition', 'Visuomotor Precision and Statue subtests of the Neuropsychological Evaluation Battery (NEPSY-2), the Teddy Bear Cancellation Test']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",52.0,0.0682661,"PMR provided an effective relaxation technique and enhanced attention and executive functioning of these 5-6-year-old children, with important implications for assisting learning and academic achievement among young children.","[{'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Jarraya', 'Affiliation': 'Research Unit, High Institute of Sport and Physical Education, Sfax University, Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Jarraya', 'Affiliation': 'Research Unit, High Institute of Sport and Physical Education, Sfax University, Sfax, Tunisia.'}, {'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Engel', 'Affiliation': 'Chair of Integrative and Experimental Exercise Science and Training, 9190University of Würzburg, Germany.'}]",Perceptual and motor skills,['10.1177/00315125221080334']
382,35090803,Teaching brief motivational interviewing to medical students using a pedagogical framework.,"OBJECTIVE


Medical schools are charged with assisting medical students to acquire the confidence, knowledge and skills for behavior change conversations in primary healthcare. The present study evaluated teaching brief motivational interviewing (MI) to pre-clinical medical students.
METHODS


Forty-six students participated in an educational intervention premised on the Learn, See, Practice, Prove, Do, Maintain pedagogical framework, comprising 2 × 2-h lectures, a 2-h role-play triad session, and 3 × 2-h small group simulated patient encounters supported by scaffolding strategies. Measures of brief MI knowledge (MI Knowledge and Attitudes Test & Multiple-Choice Knowledge Test) and confidence (MI Confidence Scale) were taken at baseline, post-training, and 3-month follow-up, and skills (Behavior Change Counseling Index) were assessed at three intervals during simulated patient encounters.
RESULTS


Students who received brief MI training improved in knowledge and confidence from baseline to post-training and gains remained at 3-months. Brief MI skills improved across the simulation sessions.
CONCLUSION


Pre-clinical medical students can attain knowledge, confidence and skills in brief MI after participation in a short intervention and improvements are sustainable.
PRACTICE IMPLICATIONS


Our results support the use of an evidence-based pedagogical framework for teaching brief MI in pre-clinical years of medical curricula and our scaffolding strategy affords promise.",2022,"RESULTS


Students who received brief MI training improved in knowledge and confidence from baseline to post-training and gains remained at 3-months.",['Forty-six students participated in an'],"['brief MI training', 'teaching brief motivational interviewing (MI', 'educational intervention']","['Brief MI skills', '3-month follow-up, and skills (Behavior Change Counseling Index', 'brief MI knowledge (MI Knowledge and Attitudes Test & Multiple-Choice Knowledge Test) and confidence (MI Confidence Scale', 'knowledge and confidence']","[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0431066', 'cui_str': 'Attitude testing'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",46.0,0.0226167,"RESULTS


Students who received brief MI training improved in knowledge and confidence from baseline to post-training and gains remained at 3-months.","[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Edwards', 'Affiliation': 'School of Education, The University of Queensland, QLD 4072, Australia. Electronic address: elizabeth.edwards@uq.edu.au.'}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Arora', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, QLD 4229, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Green', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, QLD 4229, Australia.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Bannatyne', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, QLD 4229, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Nielson', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, QLD 4229, Australia.'}]",Patient education and counseling,['10.1016/j.pec.2022.01.012']
383,35092447,Comparison of agents using higher dose anti-VEGF therapy for treatment-resistant neovascular age-related macular degeneration.,"PURPOSE


To explore the comparative efficacy and safety of higher dose intravitreal bevacizumab, ranibizumab, or aflibercept for treatment-resistant neovascular age-related macular degeneration (nAMD).
METHODS


Retrospective analysis of 37 eyes of 35 patients with treatment-resistant nAMD divided into 3 cohorts based on high-dose treatment received: 3 mg aflibercept, 0.75 mg or 1.0 mg ranibizumab, and 1.8 mg or 2.5 mg bevacizumab. The eyes were analyzed at standardized time points up to 48 months. Included eyes demonstrated active nAMD with persistent exudation on imaging for at least 6 months with at least 4 anti-VEGF injections during this time. Outcomes included change in visual acuity (VA), central retinal thickness (CRT), intraocular pressure (IOP), retinal morphology, adverse event occurrence, and yearly intravitreal injection (IVI) rate.
RESULTS


There was no significant difference in VA or IOP change compared to the initiation of high-dose treatment for any agent or comparing between agents at any time point (p > 0.05). CRT improved at month 1, 3, 6, and 12 with all 3 agents (p < 0.05 for all) with a greater CRT reduction seen for ranibizumab than aflibercept at month 6 (p < 0.05), although baseline CRT was greater in the ranibizumab group than the aflibercept group (p < 0.05). Mean absolute CRT was similar at month 6 for all agents (p > 0.05). IVI rates pre- and post-conversion to higher-dose therapy were similar (1 injection per 5.7-6.4 weeks). Mean follow-up was 22.8 months.
CONCLUSIONS


Higher dose therapy may achieve improved anatomic outcomes and maintain vision, but frequent injections are required to achieve this. There was no detected difference in efficacy or safety between agents.",2022,There was no significant difference in VA or IOP change compared to the initiation of high-dose treatment for any agent or comparing between agents at any time point (p > 0.05).,"['Retrospective analysis of 37 eyes of 35 patients with treatment-resistant nAMD divided into 3 cohorts based on high-dose treatment received', 'treatment-resistant neovascular age-related macular degeneration (nAMD']","['3\xa0mg aflibercept, 0.75\xa0mg or 1.0\xa0mg ranibizumab, and 1.8\xa0mg or 2.5\xa0mg bevacizumab', 'higher dose anti-VEGF therapy', 'aflibercept', 'intravitreal bevacizumab, ranibizumab, or aflibercept', 'ranibizumab']","['Mean absolute CRT', 'CRT', 'efficacy or safety', 'baseline CRT', 'VA or IOP change', 'anatomic outcomes and maintain vision', 'IVI rates pre- and post-conversion', 'change in visual acuity (VA), central retinal thickness (CRT), intraocular pressure (IOP), retinal morphology, adverse event occurrence, and yearly intravitreal injection (IVI) rate']","[{'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4727874', 'cui_str': 'Anti-VEGF therapy'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",35.0,0.0721871,There was no significant difference in VA or IOP change compared to the initiation of high-dose treatment for any agent or comparing between agents at any time point (p > 0.05).,"[{'ForeName': 'Geoffrey K', 'Initials': 'GK', 'LastName': 'Broadhead', 'Affiliation': 'Division of Epidemiology & Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Tiarnan D L', 'Initials': 'TDL', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology & Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology & Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Wiley', 'Affiliation': 'Division of Epidemiology & Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Cukras', 'Affiliation': 'Division of Epidemiology & Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD, 20892, USA. cukrasc@nei.nih.gov.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-021-05547-9']
384,35081757,"Narrative Messages, Information Seeking and COVID-19 Vaccine Intention: The Moderating Role of Perceived Behavioral Control.","PURPOSE


The main purposes of the current study are to examine 1) the influence of narrative vs statistics messages on COVID-19 related information seeking and COVID-19 vaccine intention and 2) the moderating role of perceived behavioral control (PBC).
DESIGN


Data for a between-subject randomized experiment were collected online. The manipulation messages were presented as screenshots from the CDC's Facebook page.
SETTING


The participants were recruited from Amazon MTurk.
SUBJECTS


A total of 300 subjects participated in the study, who were 18 years and above ( M  = 38.40).
MEASURES


Intention to seek information, COVID-19 vaccine intention, and PBC.
ANALYSIS


To test the hypotheses, we utilized Hayes's (2014) PROCESS for SPSS (Model 1). For intention to seek information, the main effect of the message manipulation (narrative vs statistics) [ b  = -2.10,  t  (300) = -4.14, P < .001] and the interaction [ b  = .41,  t  (300) = 3.88,  P  < .001] were significant. For vaccine intention, the main effects of message manipulation [ b  = 1.64,  t  (300) = -2.61,  P  < .005] and the interaction [ b  = .34,  t  (300) = 2.64,  P  < .005] were significant.
RESULTS


Our research found that narrative messages were more persuasive for both information seeking and vaccine intention. But this was true only in the case of individuals whose PBC was low.
CONCLUSIONS


Our findings have critical implications for vaccine promotion research.",2022,"For vaccine intention the main effects of message manipulation [b = 1.64, t (300) =","['The participants were recruited from Amazon MTurk', '300 subjects participated in the study, who were 18 years and above (M = 38.40']","['Narrative messages, information seeking and COVID-19 vaccine intention']","['Intention to seek information, COVID-19 vaccine intention, and PBC']","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}]",300.0,0.179884,"For vaccine intention the main effects of message manipulation [b = 1.64, t (300) =","[{'ForeName': 'Porismita', 'Initials': 'P', 'LastName': 'Borah', 'Affiliation': 'Edward R. Murrow College of Communication, 6760Washington State University Pullman, Pullman, WA, USA.'}, {'ForeName': 'Xizhu', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'School of Journalism and Communication, 12593Qingdao University, Qingdao, China.'}, {'ForeName': 'Danielle Ka Lai', 'Initials': 'DKL', 'LastName': 'Lee', 'Affiliation': 'Edward R. Murrow College of Communication, 6760Washington State University Pullman, Pullman, WA, USA.'}]",American journal of health promotion : AJHP,['10.1177/08901171221075019']
385,35081595,Prehospital low titer group O whole blood is feasible and safe: Results of a prospective randomized pilot trial.,"INTRODUCTION


Low titer group O whole blood (LTOWB) resuscitation is increasingly common in both military and civilian settings. Data regarding the safety and efficacy of prehospital LTOWB remain limited.
METHODS


We performed a single-center, prospective, cluster randomized, prehospital through in-hospital whole blood pilot trial for injured air medical patients. We compared standard prehospital air medical care including red cell transfusion and crystalloids followed by in-hospital component transfusion to prehospital and in-hospital LTOWB resuscitation. Prehospital vital signs were used as inclusion criteria (systolic blood pressure ≤90 mm Hg and heart rate ≥108 beats per minute or systolic blood pressure ≤70 mm Hg for patients at risk of hemorrhage). Primary outcome was feasibility. Secondary outcomes included 28-day and 24-hour mortality, multiple organ failure, nosocomial infection, 24-hour transfusion requirements, and arrival coagulation parameters.
RESULTS


Between November 2018 and October 2020, 86 injured patients were cluster randomized by helicopter base. The trial has halted early at 77% enrollment. Overall, 28-day mortality for the cohort was 26%. Injured patients randomized to prehospital LTOWB (n = 40) relative to standard care (n = 46) were similar in demographics and injury characteristics. Intent-to-treat Kaplan-Meier survival analysis demonstrated no statistical mortality benefit at 28 days (25.0% vs. 26.1%, p = 0.85). Patients randomized to prehospital LTOWB relative to standard care had lower red cell transfusion requirements at 24 hours (p < 0.01) and a lower incidence of abnormal thromboelastographic measurements. No transfusion reactions during the prehospital or in-hospital phase of care were documented.
CONCLUSION


Prehospital through in-hospital LTOWB resuscitation is safe and may be associated with hemostatic benefits. A large-scale clinical trial is feasible with protocol adjustment and would allow the effects of prehospital LTOWB on survival and other pertinent clinical outcomes to be appropriately characterized.
LEVEL OF EVIDENCE


Therapeutic/Care Management, Level II.",2022,Patients randomized to prehospital LTOWB relative to standard care had lower red cell transfusion requirements at 24 hours (p < 0.01) and a lower incidence of abnormal thromboelastographic measurements.,"['injured air medical patients', 'Between November 2018 thru October 2020, 86 injured patients were cluster randomized by helicopter base']","['prehospital LTOWB', 'standard prehospital air medical care including red cell transfusion and crystalloids followed by in-hospital component transfusion to prehospital and in-hospital LTOWB resuscitation', 'Low titer group O whole blood (LTOWB) resuscitation']","['28-day and 24 hour mortality, multiple organ failure, nosocomial infection, 24 hr transfusion requirements and arrival coagulation parameters', 'abnormal thromboelastographic measurements', 'red cell transfusion requirements', 'transfusion reactions', '28-day mortality']","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0018875', 'cui_str': 'Helicopter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0427626', 'cui_str': 'Group O'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}]",46.0,0.0874519,Patients randomized to prehospital LTOWB relative to standard care had lower red cell transfusion requirements at 24 hours (p < 0.01) and a lower incidence of abnormal thromboelastographic measurements.,"[{'ForeName': 'Frank X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'From the Department of Emergency Medicine (F.X.G.), Department of Surgery (M.Z., J.B.B., L.A., M.D.N., R.M.F., B.S.Z., A.B.P., T.R.B., J.L.S.), Department of Pathology (D.J.T., M.H.Y.), Institute for Transfusion Medicine, and Department of Critical Care Medicine (H.S., B.J.E., P.W.A.), University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Zenati', 'Affiliation': ''}, {'ForeName': 'Darrell J', 'Initials': 'DJ', 'LastName': 'Triulzi', 'Affiliation': ''}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Yazer', 'Affiliation': ''}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Skroczky', 'Affiliation': ''}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Early', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Alarcon', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Forsythe', 'Affiliation': ''}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Peitzman', 'Affiliation': ''}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Billiar', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003551']
386,35094925,A Pharmacokinetic and Plasmin-Generation Pharmacodynamic Assessment of a Tranexamic Acid Regimen Designed for Cardiac Surgery With Cardiopulmonary Bypass.,"OBJECTIVES


To examine the pharmacokinetics (PK) and pharmacodynamics of a tranexamic (TXA) regimen designed for cardiac surgery with cardiopulmonary bypass (CPB).
DESIGN


A pilot study quantifying TXA concentrations, fibrinolysis markers, and a plasmin- generation (PG) assay. For comparison, PG assay was performed on pooled normal plasma (PNP) with varying TXA concentrations.
SETTING


A single-center, tertiary, academic medical center.
PARTICIPANTS


Twenty patients undergoing cardiac surgery with CPB for valve surgery and/or coronary artery bypass grafting.
INTERVENTION


TXA 100 mg/h infusion for 5 hours starting before incision; 1 g TXA in CPB prime and 1 g TXA at CPB end prior to heparin reversal.
MEASUREMENTS AND MAIN RESULTS


The PK fit a 2-compartment disposition model. TXA concentrations were above 15 mg/L in all patients during CPB through 2 hours post-TXA infusion. During and after CPB, the TXA regimen decreased the median peak PG by 60% (95% confidence interval [CI], 56%-62%). Lowest median peak PG occurred 15 minutes postprotamine. Peak median D-dimer level of 1.24 (0.95-1.71; 95% CI) mg/L occurred at 15 minutes postprotamine and baseline-adjusted ΔD dimer correlated with increased CPB time (p = 0.004) and lower TXA level (p = 0.001). The median 24-hour chest tube output was 447 (330-664; 95% CI) mL. PG assay on PNP revealed a plateau inhibition at 5 mM TXA (786 mg/L).
CONCLUSIONS


This regimen, with total perioperative dose of 2.5 grams, provided TXA concentrations above 15 mg/L for all patients from CPB initiation through 2 hours post-TXA. PG was significantly inhibited (p < 0.0001) during and after CPB, with maximum inhibition measured at 15 minutes after protamine administration.",2022,TXA concentrations were above 15 mg/L in all patients during CPB through 2 hours post-TXA infusion.,"['Cardiac Surgery With Cardiopulmonary Bypass', 'cardiac surgery with cardiopulmonary bypass (CPB', 'A single-center, tertiary, academic medical center', 'Twenty patients undergoing cardiac surgery with CPB for valve surgery and/or coronary artery bypass grafting']","['TXA', 'tranexamic (TXA', 'Tranexamic Acid']","['Peak median D-dimer level', 'median 24-hour chest tube output', 'PG', 'lower TXA level', 'TXA concentrations, fibrinolysis markers, and a plasmin- generation (PG) assay', 'CPB time', 'TXA concentrations', 'median peak PG']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016016', 'cui_str': 'Plasmin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time'}]",20.0,0.149869,TXA concentrations were above 15 mg/L in all patients during CPB through 2 hours post-TXA infusion.,"[{'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Strauss', 'Affiliation': 'Division of Cardiovascular Anesthesia, Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD. Electronic address: estrauss@som.umaryland.edu.'}, {'ForeName': 'Shuhui', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy Practice and Science, Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD.'}, {'ForeName': 'Reney', 'Initials': 'R', 'LastName': 'Henderson', 'Affiliation': 'Division of Cardiovascular Anesthesia, Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Carpenter', 'Affiliation': 'Division of Cardiovascular Anesthesia, Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD.'}, {'ForeName': 'Kiruphagaran', 'Initials': 'K', 'LastName': 'Thangaraju', 'Affiliation': 'Departments of Pathology and Pediatrics, Center for Blood Oxygen Transport & Hemostasis, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Katneni', 'Affiliation': 'Departments of Pathology and Pediatrics, Center for Blood Oxygen Transport & Hemostasis, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Buehler', 'Affiliation': 'Departments of Pathology and Pediatrics, Center for Blood Oxygen Transport & Hemostasis, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jogarao V S', 'Initials': 'JVS', 'LastName': 'Gobburu', 'Affiliation': 'Department of Pharmacy Practice and Science, Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD.'}, {'ForeName': 'Kenichi A', 'Initials': 'KA', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesiology, University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.12.029']
387,35099281,Anticipated Basal Insulin Reduction to Prevent Exercise-Induced Hypoglycemia in Adults and Adolescents Living with Type 1 Diabetes.,"Objective:  We investigated the effect of two key timings for basal insulin rate reduction on exercise-induced glucose changes and explored the association between circulating insulin concentrations and muscle vasoreactivity.  Research Design and Methods:  Twenty adults and adolescents performed 60-min exercise sessions (ergocycle) at 60% VO 2peak , 240 min after a standardized lunch. In a randomized order, we compared an 80% basal insulin reduction applied 40 min (T-40) or 90 min (T-90) before exercise onset. Near-infrared spectroscopy was used to investigate muscle hemodynamics at vastus lateralis. Glucose and insulin plasma concentrations were measured.  Results:  Reduction in plasma glucose (PG) level during exercise was attenuated during T-90 versus T-40 strategy (-0.89 ± 1.89 mmol/L vs. -2.17 ± 2.49 mmol/L, respectively;  P  = 0.09). Linear mixed model analysis showed that PG dropped by an additional 0.01 mM per minute in T-40 versus T-90 (time × strategy interaction,  P  < 0.05). The absolute number of hypoglycemic events was not different between the two strategies, but they occurred later with T-90. Free insulin tends to decrease more during the pre-exercise period in the T-90 strategy ( P  = 0.08). Although local muscle vasodilatation (ΔTHb) was comparable between the two strategies, we found that PG dropped more in cases of higher exercise-induced skeletal muscle vasodilatation (ΔTHb × time interaction  P  < 0.005,  e : -0.0086 mM/min and additional mM of ΔTHb).  Conclusion:  T-90 timing reduced exercise-induced drop in PG and delayed the occurrence of hypoglycemic episodes compared with T-40 timing without a significant reduction in the number of events requiring treatment. Trial registration: ClinicalTrials.gov identifier: NCT03349489.",2022,"The absolute number of hypoglycemic events was not different between the two strategies, but they occurred later with T-90. Free insulin tends to decrease more during the pre-exercise period in the T-90 strategy (p=0.08).","['Twenty adults and adolescents performed', 'adults and adolescents living with type 1 diabetes']","['80% basal insulin reduction applied 40-min (T-40) or 90-min (T-90) before exercise onset', '60-min exercise sessions (ergocyle) at 60% VO2peak, 240min after a standardized lunch']","['skeletal muscle vasodilatation', 'absolute number of hypoglycemic events', 'local muscle vasodilatation (∆THb', 'plasma glucose level (PG) during exercise', 'Glucose and insulin plasma concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",20.0,0.0266018,"The absolute number of hypoglycemic events was not different between the two strategies, but they occurred later with T-90. Free insulin tends to decrease more during the pre-exercise period in the T-90 strategy (p=0.08).","[{'ForeName': 'Sémah', 'Initials': 'S', 'LastName': 'Tagougui', 'Affiliation': 'Montreal Clinical Research Institute (IRCM), Montreal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Legault', 'Affiliation': 'Montreal Clinical Research Institute (IRCM), Montreal, Canada.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Heyman', 'Affiliation': ""Univ. Lille, Univ. Artois, Univ. Littoral Côte d'Opale, ULR 7369 - URePSSS - Unité de Recherche Pluridisciplinaire Sport Santé Société, Lille, France.""}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Messier', 'Affiliation': 'Montreal Clinical Research Institute (IRCM), Montreal, Canada.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Suppere', 'Affiliation': 'Montreal Clinical Research Institute (IRCM), Montreal, Canada.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Potter', 'Affiliation': 'Montreal Clinical Research Institute (IRCM), Montreal, Canada.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Pigny', 'Affiliation': 'Laboratoire de Biochimie-Hormonologie, CHU Lille, Centre de Biologie-Pathologie, Lille, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Berthoin', 'Affiliation': ""Univ. Lille, Univ. Artois, Univ. Littoral Côte d'Opale, ULR 7369 - URePSSS - Unité de Recherche Pluridisciplinaire Sport Santé Société, Lille, France.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Taleb', 'Affiliation': 'Montreal Clinical Research Institute (IRCM), Montreal, Canada.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Rabasa-Lhoret', 'Affiliation': 'Montreal Clinical Research Institute (IRCM), Montreal, Canada.'}]",Diabetes technology & therapeutics,['10.1089/dia.2021.0375']
388,35101644,Impact of body mass index on omalizumab response in adults with moderate-to-severe allergic asthma.,"BACKGROUND


Effectiveness of asthma treatment, including biologics, may be different in patients with higher body mass index (BMI).
OBJECTIVE


To evaluate response to omalizumab (dosed by serum immunoglobulin E level and weight) by BMI category.
METHODS


Pooled data from 2 randomized, double-blind, placebo-controlled studies of adults with moderate-to-severe allergic asthma were analyzed by BMI category (<25 kg/m 2  [normal or underweight], n = 397; 25 to <30 kg/m 2  [overweight], n = 330; ≥ 30 kg/m 2  [obese], n = 268). Placebo-adjusted exacerbation rate reductions were evaluated by Poisson regression modeling. Changes from baseline in forced expiratory volume in 1 second, beclomethasone dipropionate (BDP) dose, Total Asthma Symptom Score, and Asthma Quality of Life Questionnaire were evaluated by analysis of covariance.
RESULTS


Greater placebo-adjusted exacerbation rate reductions (95% confidence interval) were observed with increasing BMI (normal or underweight, -37.4% [-69.0% to 26.8%]; overweight, -52.7% [-78.4% to 3.7%]; obese, -71.9% [-86.9% to -39.5%]). There were no differences in forced expiratory volume in 1 second improvement between BMI categories at week 16 (normal or underweight, 76.2 [5.3-147.1] mL; overweight, 98.1 [13.9-182.4] mL; obese, 69.1 [-18.9 to 157.2] mL). No differences in BDP dose reduction (µg) were noted between BMI categories (normal or underweight, 23.0 [15.7-30.3]; overweight, 22.5 [13.5-31.5]; obese, 16.6 [5.8-27.3]). Fewer patients in the higher BMI categories eliminated BDP use. There were trends for smaller improvements with higher BMI in Total Asthma Symptom Score (normal/underweight, -0.52 [-0.82 to -0.22]; overweight, -0.50 [-0.80 to -0.20]; obese, -0.39 [-0.77 to 0.00]) and Asthma Quality of Life Questionnaire (normal or underweight, 0.34 [0.16-0.52]; overweight, 0.34 [0.13-0.55]; obese, 0.15 [-0.08 to 0.39]).
CONCLUSION


Omalizumab provides benefit to patients with moderate-to-severe allergic asthma, regardless of BMI.
TRIAL REGISTRATION


Studies 008/009 were conducted before clinical trial registration was required, and therefore clinical trial registration numbers are not available.",2022,"Changes from baseline in forced expiratory volume in 1 second (FEV 1), beclomethasone dipropionate (BDP) dose, Total Asthma Symptom Score (TASS), and Asthma Quality of Life Questionnaire (AQLQ) were assessed by analysis of covariance.
","['patients with moderate-to-severe allergic asthma', 'adults with moderate-to-severe allergic asthma were analyzed by BMI category (<25 kg/m 2 [normal/underweight], n\u202f=\u202f397; 25 to <30 kg/m 2 [overweight], n\u202f=\u202f330; ≥30 kg/m 2 [obese], n\u202f=\u202f268', 'adults with moderate-to-severe allergic asthma', 'overweight, 0.34 [0.13-0.55]; obese, 0.15 [-0.08, 0.39', 'patients with higher body mass index (BMI']","['omalizumab', 'Placebo', 'Omalizumab', 'placebo']","['BMI', 'AQLQ', 'exacerbation rate reductions', 'forced expiratory volume in 1 second (FEV 1), beclomethasone dipropionate (BDP) dose, Total Asthma Symptom Score (TASS), and Asthma Quality of Life Questionnaire (AQLQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C4517428', 'cui_str': '0.13'}, {'cui': 'C4517462', 'cui_str': '0.55'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C4517417', 'cui_str': '0.08'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004906', 'cui_str': 'Beclomethasone dipropionate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.416284,"Changes from baseline in forced expiratory volume in 1 second (FEV 1), beclomethasone dipropionate (BDP) dose, Total Asthma Symptom Score (TASS), and Asthma Quality of Life Questionnaire (AQLQ) were assessed by analysis of covariance.
","[{'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Geng', 'Affiliation': 'The University of California San Diego School of Medicine, San Diego, California.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Dixon', 'Affiliation': 'University of Vermont Medical Center, Burlington, Vermont.'}, {'ForeName': 'Jinnie', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Pranathi', 'Initials': 'P', 'LastName': 'Janampally', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Tmirah', 'Initials': 'T', 'LastName': 'Haselkorn', 'Affiliation': 'Astellas Gene Therapies, San Francisco, California.'}, {'ForeName': 'Cecile T J', 'Initials': 'CTJ', 'LastName': 'Holweg', 'Affiliation': 'Genentech, Inc., South San Francisco, California. Electronic address: holweg.cecile@gene.com.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'Division of Allergy and Immunolgy, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Jarjour', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, Wisconsin.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2022.01.025']
389,35101183,"Reducing asthma attacks in children using exhaled nitric oxide (RAACENO) as a biomarker to inform treatment strategy: a multicentre, parallel, randomised, controlled, phase 3 trial.","BACKGROUND


The benefit of fractional exhaled nitric oxide (FeNO) in guiding asthma treatment is uncertain. We evaluated the efficacy of adding FeNO to symptom-guided treatment in children with asthma versus only symptom-guided treatment.
METHODS


RAACENO was a multicentre, parallel, randomised, controlled, phase 3 trial done in 35 secondary care centres and 17 primary care recruitment sites (only seven primary care sites managed to recruit patients) in the UK. Patients with a confirmed asthma diagnosis, aged 6-15 years, prescribed inhaled corticosteroids, and who received a course of oral corticosteroids for at least one asthma exacerbation during the 12 months before recruitment were included. Participants were randomly assigned to either FeNO plus symptom-guided treatment (intervention) or symptom-guided treatment alone (standard care) using a 24 h in-house, web-based randomisation system. Participants and the clinical and research teams were not masked to the group allocation. A web-based algorithm gave treatment recommendations based on the Asthma Control Test (ACT) or Childhood ACT (CACT) score; current asthma treatment; adherence to study treatment in the past 3 months; and use of FeNO (in the intervention group). Follow-up occurred at 3-month intervals for 12 months. The primary outcome was any asthma exacerbation treated with oral corticosteroids in the 12 months after randomisation, assessed in the intention-to-treat population. This study is registered with the International Standard Randomised Controlled Trial Registry, ISRCTN67875351.
FINDINGS


Between June 22, 2017, and Aug 8, 2019, 535 children were assessed for eligibility, 20 were ineligible and six were excluded post-randomisation. 509 children were recruited and at baseline, the mean age of participants was 10·1 years (SD 2·6), and 308 (60·5%) were male. The median FeNO was 21 ppb (IQR 10-48), mean predicted FEV 1  was 89·6% (SD 18·0), and median daily dose of inhaled corticosteroids was 400 μg budesonide equivalent (IQR 400-1000). Asthma was partly or fully controlled in 256 (50·3%) of 509 participants. The primary outcome, which was available for 506 (99%) of 509 participants, occurred in 123 (48·2%) of 255 participants in the intervention group and 129 (51·4%) of 251 in the standard care group, the intention-to-treat adjusted odds ratio (OR) was 0·88 (95% CI 0·61 to 1·27; p=0·49). The adjusted difference in the percentage of participants who received the intervention in whom the primary outcome occurred compared with those who received standard care was -3·1% (-11·9% to 5·6%). In 377 (21·3%) of 1771 assessments, the algorithm recommendation was not followed. Adverse events were reported by 27 (5·3%) of 509 participants (15 in the standard care group and 12 in the intervention group). The most common adverse event was itch after skin prick testing (reported by eight participants in each group).
INTERPRETATION


We found that the addition of FeNO to symptom-guided asthma treatment did not lead to reduced exacerbations among children prone to asthma exacerbation. Asthma symptoms remain the only tool for guiding treatment decisions.
FUNDING


National Institute for Health Research.",2022,Adverse events were reported by 27 (5·3%) of 509 participants (15 in the standard care group and 12 in the intervention group).,"['Patients with a confirmed asthma diagnosis, aged 6-15 years, prescribed inhaled corticosteroids, and who received a course of oral corticosteroids for at least one asthma exacerbation during the 12 months before recruitment were included', 'Between June 22, 2017, and Aug 8, 2019, 535 children were assessed for eligibility, 20 were ineligible and six were excluded post-randomisation', 'children with asthma versus only symptom-guided treatment', '509 children were recruited and at baseline, the mean age of participants was 10·1 years (SD 2·6), and 308 (60·5%) were male', '35 secondary care centres and 17 primary care recruitment sites (only seven primary care sites managed to recruit patients) in the UK', 'Asthma was partly or fully controlled in 256 (50·3%) of 509 participants']","['FeNO', 'inhaled corticosteroids', 'fractional exhaled nitric oxide (FeNO', 'FeNO plus symptom-guided treatment (intervention) or symptom-guided treatment alone (standard care) using a 24 h in-house, web-based randomisation system']","['asthma exacerbation treated with oral corticosteroids', 'intention-to-treat population', 'standard care', 'Adverse events', 'median FeNO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}]",535.0,0.656285,Adverse events were reported by 27 (5·3%) of 509 participants (15 in the standard care group and 12 in the intervention group).,"[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': ""Royal Aberdeen Children's Hospital, University of Aberdeen, Aberdeen, UK. Electronic address: s.w.turner@abdn.ac.uk.""}, {'ForeName': 'Seonaidh', 'Initials': 'S', 'LastName': 'Cotton', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Bell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Edwin-Amalraj', 'Initials': 'EA', 'LastName': 'Raja', 'Affiliation': 'Department of Medical Statistics, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Neil W', 'Initials': 'NW', 'LastName': 'Scott', 'Affiliation': 'Department of Medical Statistics, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Morgan', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Lawrie', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Emele', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kennedy', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Scotland', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Fielding', 'Affiliation': 'Department of Medical Statistics, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Erol A', 'Initials': 'EA', 'LastName': 'Gaillard', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'de Jongste', 'Affiliation': 'Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Pijnenburg', 'Affiliation': 'Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; Observational and Pragmatic Research Institute, Singapore.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00486-0']
390,35100468,Cerium oxide nanoparticles administration during machine perfusion of discarded human livers: A pilot study.,"The combined approach of ex situ normothermic machine perfusion (NMP) and nanotechnology represents a strategy to mitigate ischemia/reperfusion injury in liver transplantation (LT). We evaluated the uptake, distribution, and efficacy of antioxidant cerium oxide nanoparticles (nanoceria) during normothermic perfusion of discarded human livers. A total of 9 discarded human liver grafts were randomized in 2 groups and underwent 4 h of NMP: 5 grafts were treated with nanoceria conjugated with albumin (Alb-NC; 50 µg/ml) and compared with 4 untreated grafts. The intracellular uptake of nanoceria was analyzed by electron microscopy (EM) and inductively coupled plasma-mass spectrometry (ICP-MS). The antioxidant activity of Alb-NC was assayed in liver biopsies by glutathione (GSH), superoxide dismutase (SOD) and catalase (CAT) assay, telomere length, and 4977-bp common mitochondrial DNA deletion (mtDNA 4977  deletion). The cytokine profile was evaluated in perfusate samples. EM and ICP-MS confirmed Alb-NC internalization, rescue of mitochondrial phenotype, decrease of lipid droplet peroxidation, and lipofuscin granules in the treated grafts. Alb-NC exerted an antioxidant activity by increasing GSH levels (percentage change: +94% ± 25%; p = 0.01), SOD (+17% ± 4%; p = 0.02), and CAT activity (51% ± 23%; p = 0.03), reducing the occurrence of mtDNA 4977  deletion (-67.2% ± 11%; p = 0.03), but did not affect cytokine release. Alb-NC during ex situ perfusion decreased oxidative stress, upregulating graft antioxidant defense. They could be a tool to improve quality grafts during NMP and represent an antioxidant strategy aimed at protecting the graft against reperfusion injury during LT.",2022,"Alb-NC exerted an antioxidant activity by increasing glutathione levels (%change: +94%±25%; p=0.01), superoxide dismutase (+17%±4%; p=0.02), and catalase activity (51%±23%; p=0.03), reducing the occurrence of mtDNA 4977  deletion (-67.2%±11%; p=0.03), but did not affect cytokine release.","['discarded human livers', 'liver transplantation', 'Nine discarded human liver grafts']","['antioxidant cerium oxide nanoparticles (nanoceria', 'nanoceria conjugated with albumin (Alb-NC; 50 µmol/L', 'Cerium oxide nanoparticles administration', 'ex situ normothermic machine perfusion (NMP) and nanotechnology']","['oxidative stress', 'occurrence of mtDNA 4977  deletion', 'assay, telomere length, and 4977-bp common mitochondrial DNA deletion (mtDNA 4977  deletion', 'antioxidant activity', 'catalase activity', 'antioxidant activity of Alb-NC', 'lipid droplet peroxidation, and lipofuscin granules', 'Cytokine profile', 'liver biopsies by glutathione, superoxide dismutase and catalase', 'superoxide dismutase', 'glutathione levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0055114', 'cui_str': 'ceric oxide'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C3178751', 'cui_str': 'nanoceria'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0872323', 'cui_str': 'Nanotechnology'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0948051', 'cui_str': 'Mitochondrial DNA deletion'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0230704', 'cui_str': 'Lipid droplet'}, {'cui': 'C0230820', 'cui_str': 'Residual body'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}]",,0.0363841,"Alb-NC exerted an antioxidant activity by increasing glutathione levels (%change: +94%±25%; p=0.01), superoxide dismutase (+17%±4%; p=0.02), and catalase activity (51%±23%; p=0.03), reducing the occurrence of mtDNA 4977  deletion (-67.2%±11%; p=0.03), but did not affect cytokine release.","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Del Turco', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cappello', 'Affiliation': 'Center for Materials Interfaces, Electron Crystallography, Istituto Italiano di Tecnologia, Pontedera, Italy.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Tapeinos', 'Affiliation': 'Smart Bio-Interfaces, Istituto Italiano di Tecnologia, Pontedera, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Moscardini', 'Affiliation': 'National Enterprise for nanoScience and nanoTechnology, Scuola Normale Superiore, Pisa, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sabatino', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Battaglini', 'Affiliation': 'Smart Bio-Interfaces, Istituto Italiano di Tecnologia, Pontedera, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Melandro', 'Affiliation': 'Division of Hepatic Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Torri', 'Affiliation': 'Division of Hepatic Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Martinelli', 'Affiliation': 'Division of Hepatic Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Babboni', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Silvestrini', 'Affiliation': 'Division of Interventional Radiology, University of Pisa Medical School Hospital, Pisa, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Morganti', 'Affiliation': 'Department of Statistics, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Gemmi', 'Affiliation': 'Center for Materials Interfaces, Electron Crystallography, Istituto Italiano di Tecnologia, Pontedera, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'De Simone', 'Affiliation': 'Division of Hepatic Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Italy.'}, {'ForeName': 'Paulo N', 'Initials': 'PN', 'LastName': 'Martins', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of Massachusetts, Worcester, Massachusetts, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Crocetti', 'Affiliation': 'Division of Interventional Radiology, University of Pisa Medical School Hospital, Pisa, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Peris', 'Affiliation': 'Regional Transplant Authority of Tuscany, Florence, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Campani', 'Affiliation': 'Division of Pathology, University of Pisa Medical School Hospital, Pisa, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Basta', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Ciofani', 'Affiliation': 'Smart Bio-Interfaces, Istituto Italiano di Tecnologia, Pontedera, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Ghinolfi', 'Affiliation': 'Division of Hepatic Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Italy.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.26421']
391,35102732,Stimulation of both inspiratory and expiratory muscles versus diaphragm-only paradigm for rehabilitation in severe chronic obstructive pulmonary disease patients: a randomized controlled pilot study.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD), a progressive lung disease, might improve with neuromuscular electrical stimulation. No trials on inspiratory plus expiratory neuromuscular electrical stimulation have been conducted yet.
AIM


The aim of this study was to evaluate the safety and effectiveness of inspiratory plus expiratory neuromuscular electrical stimulation in subjects with severe COPD.
DESIGN


This was a multicenter, prospective, randomized controlled trial.
SETTING


The subjects were outpatients enrolled from Beijing Chao-Yang Hospital affiliated with Capital Medical University, Tianjin Chest Hospital, and the First Hospital of Hebei Medical University.
POPULATION


Subjects had stable COPD with severe respiratory impairment.
METHODS


Using a computer statistical software, 120 stable subjects were randomly allocated (1:1) to receive inspiratory plus expiratory neuromuscular electrical stimulation (study group) and diaphragm pacing (control group). Demographic and clinical data were collected before, and after 2, and 4 weeks of the trial. The intention-to-treat analysis was conducted. The primary outcome was to analyze the changes in functional exercise capacity, estimated as six-minute walk distance (6MWD), following electrical stimulation for 4 weeks. The secondary outcomes were changes in modified Medical Research Council score, forced expiratory volume in 1 second (FEV<inf>1</inf>), FEV<inf>1</inf>% predicted, and FEV<inf>1</inf> ratio forced vital capacity (FEV<inf>1</inf>/FVC) following electrical stimulation for 4 weeks.
RESULTS


The change in 6MWD was greater in the study group (65.53±39.45 m) than in the control group (26.66±32.65 m). The mean between-group difference at the fourth week was 29.07 m (95% confidence interval, 16.098-42.035; P<0.001). There were no significant between-group differences in the secondary outcomes after 4 weeks of electrical stimulation. For GOLD-4 COPD subjects, FEV<inf>1</inf> and FEV<inf>1</inf>/FVC improved in the study group (P<0.05). No electrical stimulation-related serious adverse events were observed in either group.
CONCLUSIONS


6MWD were increased significantly, without adverse events, after four weeks of treatment of inspiratory plus expiratory neuromuscular electrical stimulation in stable patients with severe COPD, suggesting that this protocol benefits COPD rehabilitation.
CLINICAL REHABILITATION IMPACT


The results of this study suggest that the simultaneous use of inspiratory plus expiratory neuromuscular electrical stimulation as an adjunct therapy may improve the functional exercise capacity of severe stable COPD subjects.",2022,The change in 6-MWD was greater in the study group (65.53 ± 39.45 m) than in the control group (26.66 ± 32.65 m).,"['Chronic obstructive pulmonary disease (COPD', 'subjects with severe COPD', 'Subjects had stable COPD with severe respiratory impairment', 'The subjects were outpatients enrolled from Beijing Chao-Yang Hospital affiliated with Capital Medical University, Tianjin Chest Hospital, and the First Hospital of Hebei Medical University', 'severe COPD patients', 'stable patients with severe COPD', 'severe stable COPD subjects', '120 stable subjects']","['inspiratory plus expiratory neuromuscular electrical stimulation', 'inspiratory plus expiratory neuromuscular electrical stimulation (study group) and diaphragm pacing (control group', 'inspiratory plus expiratory muscles versus diaphragm-only paradigm']","['functional exercise capacity', 'changes in modified Medical Research Council score, forced expiratory volume in 1 second (FEV1), FEV1% predicted, and FEV1 ratio forced vital capacity (FEV1/FVC', 'FEV1 and FEV1/FVC', 'electrical stimulation-related serious adverse events', 'change in 6-MWD', 'changes in functional exercise capacity, estimated as six-minute walk distance (6-MWD), following electrical stimulation for 4 weeks']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035229', 'cui_str': 'Respiratory insufficiency'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301400', 'cui_str': 'Diaphragm pacing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}]","[{'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}]",120.0,0.0776786,The change in 6-MWD was greater in the study group (65.53 ± 39.45 m) than in the control group (26.66 ± 32.65 m).,"[{'ForeName': 'Zhiling', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wuzhuang', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Respiratory Medicine and PCCM, The First Hospital of Hebei Medical University, Shijiazhuang City, Hebei Province, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of General Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yingxiang', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Medicine and PCCM, The First Hospital of Hebei Medical University, Shijiazhuang City, Hebei Province, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Juanni', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bojun', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Yuechuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China - tongzhaohuicy@sina.com.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.22.07185-4']
392,34872102,Low-Concentration Norepinephrine Infusion for Major Surgery: A Safety and Feasibility Pilot Randomized Controlled Trial.,"BACKGROUND


Prevention of hypotension during the intra- and postoperative period is an important goal. Peripheral administration of low-concentration norepinephrine may be a safe and effective strategy to reduce the risk of hypotension.
METHODS


We conducted a 2-center, randomized pilot feasibility trial, with a target of 60 adult patients undergoing major noncardiac surgery. We randomized patients to receive a peripheral low-concentration (10 µg/mL) norepinephrine or placebo (saline 0.9%) infusion. The study drug infusion was titrated to achieve a minimum systolic blood pressure target, preselected within 10% of baseline value and within the range limit 100 to 120 mm Hg during surgery and for up to 4 or 24 hours postoperatively.
RESULTS


We achieved a high consent rate (84%), successful study drug administration throughout surgery (98% of patients) and absence of unblinding. There were no important study drug-related adverse events. The average intraoperative systolic blood pressure was 120 ± 12.6 mm Hg in the norepinephrine group and 115 ± 14.9 mm Hg in the placebo group. The mean difference between the intraoperative systolic blood pressure achieved less the preselected minimum systolic blood pressure target was 10.0 ± 12.7 mm Hg in the norepinephrine group and 2.9 ± 14.7 mm Hg in the placebo group; difference in means, 7.1 (95% confidence interval, 0.2-14.0) mm Hg.
CONCLUSIONS


A future large trial evaluating the effectiveness and safety of peripheral administration of low-concentration norepinephrine during the perioperative period is feasible, and likely to achieve a minimum systolic blood pressure threshold.",2022,There were no important study drug-related adverse events.,"['Major Surgery', '60 adult patients undergoing major noncardiac surgery']","['placebo', 'low-concentration norepinephrine', 'Peripheral administration of low-concentration norepinephrine', 'peripheral low-concentration (10 µg/mL) norepinephrine or placebo (saline 0.9%) infusion', 'Low-Concentration Norepinephrine Infusion', 'norepinephrine']","['average intraoperative systolic blood pressure', 'intraoperative systolic blood pressure', 'minimum systolic blood pressure target']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1282149', 'cui_str': 'Minimum systolic blood pressure'}]",60.0,0.522863,There were no important study drug-related adverse events.,"[{'ForeName': 'Verna M', 'Initials': 'VM', 'LastName': 'Aykanat', 'Affiliation': 'From the Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Myles', 'Affiliation': 'From the Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Weinberg', 'Affiliation': 'Department of Anaesthesia, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Aidan', 'Initials': 'A', 'LastName': 'Burrell', 'Affiliation': 'Department of Intensive Care, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005811']
393,35102419,"Substitution of Refined Conventional Wheat Flour with Wheat High in Resistant Starch Modulates the Intestinal Microbiota and Fecal Metabolites in Healthy Adults: A Randomized, Controlled Trial.","BACKGROUND


Resistant starch (RS) confers many health benefits, mostly through the microbial production of SCFAs, but foods containing appreciable RS are limited. High-amylose wheat (HAW) is high in RS and lowers the glycemic response of foods, but whether it can improve gastrointestinal health measures is unknown.
OBJECTIVES


The objective of this study was to determine whether daily consumption of HAW food products improved markers of gastrointestinal health in healthy men and women compared with similar foods made from conventional wheat.
METHODS


Eighty healthy adults (47 women and 33 men) were enrolled in a 4-arm parallel, randomized-controlled, double-blind trial. After a 2-wk low-dietary fiber run-in period, they were randomly allocated to 1 of 4 treatment groups: low-amylose wheat (LAW)-refined (LAW-R), LAW-wholemeal (LAW-W), HAW-refined (HAW-R), and HAW-wholemeal (HAW-W) and consumed the assigned test bread (160 g/d) and biscuits (75 g/d) for 4 wk. Fecal biochemical markers were measured at baseline and 4 wk. Microbial abundance and diversity were quantified using 16S ribosomal RNA sequencing and perceived gut comfort by a semiquantitative questionnaire completed at baseline, 2 wk, and 4 wk.
RESULTS


HAW showed similar effects on fecal output and excretion of total SCFA compared with LAW, but changes were observed in secondary measures for the refined treatment groups. At 4 wk, the HAW-R group had 38% higher fecal butyrate excretion than the LAW-R group (P < 0.05), and higher fecal SCFA-producing bacteria, Roseburia inulinivorans (P < 0.001), than at baseline. In comparison with baseline, LAW-R increased fecal p-cresol concentration, and fecal abundance of a p-cresol-producing bacterium, Clostridium from the Peptostreptococcaceae family, but both were reduced by HAW-R. Amylose level did not affect measures of fecal consistency or adversely affecting digestive comfort.
CONCLUSIONS


Increasing RS intake of healthy adults by substituting refined conventional wheat with refined HAW modulates fecal metabolites and microbes associated with gastrointestinal health.This trial was registered at anzctr.org.au as ACTRN12618001060235.",2022,"In comparison to baseline levels, LAW-R increased fecal p-cresol concentration, and fecal levels of a p-cresol producing bacteria, Clostridium from Peptostreptococcaceae family, but both were reduced by HAW-R. Amylose level did not affect measures of fecal consistency and was well tolerated without adversely affecting digestive comfort.
","['Eighty healthy adults (47 females and 33 males', 'healthy men and women compared to similar foods made from conventional wheat', 'healthy adults', 'Healthy Adults']","['High amylose wheat (HAW', 'low amylose wheat-refined (LAW-R), LAW-wholemeal (LAW-W), HAW-refined (HAW-R) and HAW-wholemeal (HAW-W) and consumed bread', 'Resistant starch (RS', 'HAW food products']","['Fecal biochemical markers', 'Intestinal Microbiota and Fecal Metabolites', 'fecal butyrate excretion', 'LAW-R increased fecal p-cresol concentration, and fecal levels', 'fecal consistency', 'fecal output and total SCFA levels', 'gastrointestinal health', 'Microbial abundance and diversity']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002732', 'cui_str': 'Amylose'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023150', 'cui_str': 'Law'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002732', 'cui_str': 'Amylose'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0048212', 'cui_str': '4-cresol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",80.0,0.186766,"In comparison to baseline levels, LAW-R increased fecal p-cresol concentration, and fecal levels of a p-cresol producing bacteria, Clostridium from Peptostreptococcaceae family, but both were reduced by HAW-R. Amylose level did not affect measures of fecal consistency and was well tolerated without adversely affecting digestive comfort.
","[{'ForeName': 'Shakuntla V', 'Initials': 'SV', 'LastName': 'Gondalia', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Wymond', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Benassi-Evans', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Berbezy', 'Affiliation': 'Limagrain Ingredients, Riom, France.'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Bird', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}, {'ForeName': 'Damien P', 'Initials': 'DP', 'LastName': 'Belobrajdic', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Adelaide, South Australia, Australia.'}]",The Journal of nutrition,['10.1093/jn/nxac021']
394,35108620,Effectiveness of a Brief Hypnotic Induction in Third Molar Extraction: A Randomized Controlled Trial (HypMol).,"Third molar extraction is a painful treatment for patients, and thus, it can be used to investigate the effects of analgesics on pain. Hypnosis can help to reduce pain and to decrease the intake of postoperative systemic analgesics. In this study, the effectiveness of a brief hypnotic induction for patients undergoing third molar extractions was investigated. Data were collected from 33 patients with third molar extractions on the right and left sides. Patients received 2 different types of pain interventions in this monocentric randomized crossover trial. Third molar extraction was conducted on 1 side with reduced preoperative local anesthetics and an additional brief hypnotic induction (Dave Elman technique). The other side was conducted with regular preoperative local anesthetics without a brief hypnotic induction (standard care). Intake of postoperative systemic analgesics was allowed in both treatments. Patients' expectations about hypnosis were assessed at baseline. The primary outcome was the area under the curve with respect to ground of pain intensity after the treatment. Secondary outcomes were the amount of postoperative analgesics consumed and the preferred treatment. There was no evidence that the area under the curve with respect to ground of pain differed between the 2 interventions (controlling for gender), but the patients' expectations affected the effectiveness of the brief hypnotic induction. This means that patients with high expectations about hypnosis benefit more from treatment with reduced preoperative local anesthetics and additional brief hypnotic induction. PERSPECTIVE: Hypnosis is used as a treatment to reduce pain in general and dental settings. In this study, additional a brief hypnotic induction with reduced preoperative local anesthetic use did not generally reduce posttreatment pain after third molar extraction more than regular local anesthetics. The expectation of the patients about the effectiveness of hypnosis affected the effectiveness of the brief hypnotic induction so that patients with high expectations had a larger benefit from a brief hypnotic induction than patients with low expectations.",2022,"There was no evidence that the AUC_G of pain differed between the two interventions (controlling for gender), but the patients' expectations affected the effectiveness of the brief hypnotic induction.","['patients undergoing third molar extractions', '33 patients with third molar extractions on the right and left sides', 'third molar extraction']","['hypnotic induction', 'pain interventions', 'side with reduced preoperative local anesthetics and an additional brief hypnotic induction (Dave Elman technique', 'regular preoperative local anesthetics without a brief hypnotic induction (standard care']","['AUC_G of pain', 'pain', 'amount of postoperative analgesics consumed and the preferred treatment', 'area under the curve with respect to ground (AUC_G) of pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441987', 'cui_str': 'Side'}]","[{'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",33.0,0.108787,"There was no evidence that the AUC_G of pain differed between the two interventions (controlling for gender), but the patients' expectations affected the effectiveness of the brief hypnotic induction.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Egli', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland; Praxis Meyenberger, Wil, Switzerland.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Deforth', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Keiser', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meyenberger', 'Affiliation': 'Praxis Meyenberger, Wil, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Muff', 'Affiliation': 'Department of Mathematical Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Witt', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland; University of Maryland School of Medicine, Center for Integrative Medicine, Baltimore, Maryland; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland. Electronic address: mail@juergen-barth.de.'}]",The journal of pain,['10.1016/j.jpain.2021.12.015']
395,35108031,Prophylactic Use of Compression Sleeves Reduces the Incidence of Arm Swelling in Women at High Risk of Breast Cancer-Related Lymphedema: A Randomized Controlled Trial.,"PURPOSE


To determine whether prophylactic use of compression sleeves prevents arm swelling in women who had undergone axillary lymph node dissection for breast cancer surgery.
METHODS


Women (n = 307) were randomly assigned to either a compression or control group. In addition to usual postoperative care, the compression group received two compression sleeves to wear postoperatively until 3 months after completing adjuvant treatments. Arm swelling was determined using bioimpedance spectroscopy (BIS) thresholds and relative arm volume increase (RAVI). Incidence and time free from arm swelling were compared using Kaplan-Meier analyses. Hazard ratios (HRs) were estimated from Cox regression models for BIS and RAVI thresholds independently. In addition, time to documentation of the first minimally important difference (MID) in four scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the breast cancer-specific (BR23) questionnaire was analyzed.
RESULTS


The HR for developing arm swelling in the compression group relative to the control group was 0.61 (95% CI, 0.43 to 0.85;  P  = .004) on the basis of BIS and 0.56 (95% CI, 0.33 to 0.96;  P  = .034) on the basis of RAVI. The estimated cumulative incidence of arm swelling at 1 year was lower in the compression group than the control group on the basis of BIS (42%  v  52%) and RAVI (14%  v  25%). HRs for time from baseline to the first change of the minimally important difference were not statistically significant for any of the four scales of EORTC QLQ-30 and BR23 questionnaires.
CONCLUSION


Prophylactic use of compression sleeves compared with the control group reduced and delayed the occurrence of arm swelling in women at high risk for lymphedema in the first year after surgery for breast cancer.",2022,Prophylactic use of compression sleeves compared with the control group reduced and delayed the occurrence of arm swelling in women at high risk for lymphedema in the first year after surgery for breast cancer.,"['women who had undergone axillary lymph node dissection for breast cancer surgery', 'Women (n = 307', 'Women at High Risk of Breast Cancer-Related Lymphedema']","['Compression Sleeves', 'compression or control group', 'compression sleeves']","['cumulative incidence of arm swelling', 'bioimpedance spectroscopy (BIS) thresholds and relative arm volume increase (RAVI', 'RAVI', 'Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the breast cancer-specific (BR23) questionnaire', 'Arm swelling', 'EORTC QLQ-30 and BR23 questionnaires', 'Incidence and time free from arm swelling', 'Incidence of Arm Swelling', 'Hazard ratios (HRs', 'HR for developing arm swelling', 'occurrence of arm swelling']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0577598', 'cui_str': 'Swelling of upper arm'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",307.0,0.12462,Prophylactic use of compression sleeves compared with the control group reduced and delayed the occurrence of arm swelling in women at high risk for lymphedema in the first year after surgery for breast cancer.,"[{'ForeName': 'Vincent S', 'Initials': 'VS', 'LastName': 'Paramanandam', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dylke', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Clark', 'Affiliation': 'Gary Clark Statistical Consulting LLC, Superior, CO.'}, {'ForeName': 'Anuradha A', 'Initials': 'AA', 'LastName': 'Daptardar', 'Affiliation': 'Tata Memorial Hospital, Parel, Mumbai, India.'}, {'ForeName': 'Ajeeta M', 'Initials': 'AM', 'LastName': 'Kulkarni', 'Affiliation': 'Tata Memorial Hospital, Parel, Mumbai, India.'}, {'ForeName': 'Nita S', 'Initials': 'NS', 'LastName': 'Nair', 'Affiliation': 'Tata Memorial Hospital, Parel, Mumbai, India.'}, {'ForeName': 'Rajendra A', 'Initials': 'RA', 'LastName': 'Badwe', 'Affiliation': 'Tata Memorial Hospital, Parel, Mumbai, India.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Kilbreath', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.02567']
396,35106809,Can nebulised HepArin Reduce morTality and time to Extubation in patients with COVID-19 Requiring invasive ventilation Meta-Trial (CHARTER-MT): Protocol and statistical analysis plan for an investigator-initiated international meta-trial of prospective randomised clinical studies.,"There is significant interest in the potential for nebulised unfractionated heparin (UFH), as a novel therapy for patients with COVID-19 induced acute hypoxaemic respiratory failure requiring invasive ventilation. The scientific and biological rationale for nebulised heparin stems from the evidence for extensive activation of coagulation resulting in pulmonary microvascular thrombosis in COVID-19 pneumonia. Nebulised delivery of heparin to the lung may limit alveolar fibrin deposition and thereby limit progression of lung injury. Importantly, laboratory studies show that heparin can directly inactivate the SARS-CoV-2 virus, thereby prevent its entry into and infection of mammalian cells. UFH has additional anti-inflammatory and mucolytic properties that may be useful in this context. METHODS AND INTERVENTION: The Can nebulised HepArin Reduce morTality and time to Extubation in Patients with COVID-19 Requiring invasive ventilation Meta-Trial (CHARTER-MT) is a collaborative prospective individual patient data analysis of on-going randomised controlled clinical trials across several countries in five continents, examining the effects of inhaled heparin in patients with COVID-19 requiring invasive ventilation on various endpoints. Each constituent study will randomise patients with COVID-19 induced respiratory failure requiring invasive ventilation. Patients are randomised to receive nebulised heparin or standard care (open label studies) or placebo (blinded placebo-controlled studies) while under invasive ventilation. Each participating study collect a pre-defined minimum dataset. The primary outcome for the meta-trial is the number of ventilator-free days up to day 28 day, defined as days alive and free from invasive ventilation.",2022,"The Can nebulised HepArin Reduce morTality and time to Extubation in Patients with COVID-19 Requiring invasive ventilation Meta-Trial (CHARTER-MT) is a collaborative prospective individual patient data analysis of on-going randomised controlled clinical trials across several countries in 5 continents, examining the effects of inhaled heparin in patients with COVID-19 requiring invasive ventilation on various endpoints.","['randomise patients with COVID-19 induced respiratory failure requiring invasive ventilation', 'patients with COVID-19 requiring invasive ventilation on various endpoints', 'patients with COVID-19 induced acute hypoxaemic respiratory failure requiring invasive ventilation', 'Patients with COVID-19 Requiring invasive ventilation Meta-Trial (CHARTER-MT', 'Patients with COVID-19 Requiring invasive ventilation Meta']","['nebulised HepArin', 'UFH', 'nebulised heparin or standard care (open label studies) or placebo (blinded placebo-controlled studies) while under invasive ventilation', 'heparin', 'nebulised unfractionated heparin (UFH']","['morTality and time to Extubation', 'number of ventilator-free days up to day 28 day, defined as days alive and free from invasive ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.196953,"The Can nebulised HepArin Reduce morTality and time to Extubation in Patients with COVID-19 Requiring invasive ventilation Meta-Trial (CHARTER-MT) is a collaborative prospective individual patient data analysis of on-going randomised controlled clinical trials across several countries in 5 continents, examining the effects of inhaled heparin in patients with COVID-19 requiring invasive ventilation on various endpoints.","[{'ForeName': 'Frank M P', 'Initials': 'FMP', 'LastName': 'van Haren', 'Affiliation': 'Australian National University, Canberra, Australia.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Laffey', 'Affiliation': 'Anaesthesia and Intensive Care Medicine, School of Medicine, and Regenerative Medicine Institute (REMEDI) at CÚRAM Centre for Research in Medical Devices, Biomedical Sciences Building, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Artigas', 'Affiliation': 'Critical Center, Corporació Sanitaria Parc Tauli, CIBER Enfermedades Respiratorias, Autonomous University of Barcelona, Sabadell, Spain.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Page', 'Affiliation': ""Sackler Institute of Pulmonary Pharmacology, King's College London, UK.""}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care, Amsterdam University Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cosgrave', 'Affiliation': 'Department of Anaesthesia, University Hospital Galway, Saolta Hospital Group, Ireland.'}, {'ForeName': 'Bairbre', 'Initials': 'B', 'LastName': 'McNicholas', 'Affiliation': 'Department of Anaesthesia, University Hospital Galway, Saolta Hospital Group, Ireland.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Smoot', 'Affiliation': 'Frederick Memorial Hospital, Frederick, Maryland, USA.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Nunes', 'Affiliation': 'Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Richardson', 'Affiliation': 'Australian National University, Canberra, Australia.'}, {'ForeName': 'Hwan-Jin', 'Initials': 'HJ', 'LastName': 'Yoon', 'Affiliation': 'Australian National University, Canberra, Australia.'}, {'ForeName': 'Lex M', 'Initials': 'LM', 'LastName': 'van Loon', 'Affiliation': 'Australian National University, Canberra, Australia.'}, {'ForeName': 'Angajendra', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Intensive Care Unit, The Northern Hospital, Melbourne, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Said', 'Affiliation': 'Intensive Care Unit, The Northern Hospital, Melbourne, Australia.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': ""Department of Critical Care Medicine, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Santamaria', 'Affiliation': ""Department of Critical Care Medicine, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Dixon', 'Affiliation': ""Department of Critical Care Medicine, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of clinical pharmacology,['10.1111/bcp.15253']
397,35102597,"Response to reply to ""Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial"" by Martín-Marcos et al.",,2022,,['esophagogastroduodenoscopy'],['pharyngeal lidocaine anesthesia'],[],"[{'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",[],,0.512713,,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Martín-Marcos', 'Affiliation': 'Bioaraba, Nursing and Health Care Research Group, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Estíbaliz', 'Initials': 'E', 'LastName': 'Cristóbal-Domínguez', 'Affiliation': 'Bioaraba, Nursing and Health Care Research Group, Vitoria-Gasteiz, Spain.'}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.14251']
398,35098554,Phase 2B randomized controlled trial of NP001 in amyotrophic lateral sclerosis: Pre-specified and post hoc analyses.,"INTRODUCTION/AIMS


ALS is a heterogeneous disease that may be complicated or in part driven by inflammation. NP001, a regulator of macrophage activation, was associated with slowing disease progression in those with higher levels of the plasma inflammatory marker C-reactive protein (CRP) in phase 2A studies in ALS. Here, we evaluate the effects of NP001 in a phase 2B trial, and perform a post hoc analysis with combined data from the preceding phase 2A trial.
METHODS


The phase 2B trial enrolled 138 participants within 3 y of symptom onset and with plasma hs-CRP values >1.13 mg/L. They were randomized 1:1 to receive either placebo or NP001 for 6 mo. Change from baseline ALSFRS-R scores was the primary efficacy endpoint. Secondary endpoints included vital capacity (VC) change from baseline and percentage of participants showing no decline of ALSFRS-R score over 6 mo (non-progressor).
RESULTS


The phase 2B study did not show significant differences between placebo and active treatment with respect to change in ALSFRS-R scores, or VC. The drug was safe and well tolerated. A post hoc analysis identified a 40- to 65-y-old subset in which NP001-treated patients demonstrated slower declines in ALSFRS-R score by 36% and VC loss by 51% compared with placebo. A greater number of non-progressors were NP001-treated compared with placebo (p = .004).
DISCUSSION


Although the phase 2B trial failed to meet its primary endpoints, post hoc analyses identified a subgroup whose decline in ALSFRS-R and VC scores were significantly slower than placebo. Further studies will be required to validate these findings.",2022,"NP001, a regulator of macrophage activation, was associated with slowing disease progression in those with higher levels of plasma inflammatory marker, C-reactive protein (CRP), in phase 2A studies in ALS.","['138 participants within 3\u2009years of symptom onset and with plasma hs-CRP values >\u20091.13mg', 'amyotrophic lateral sclerosis']","['placebo', 'placebo or NP001', 'NP001']","['safe and well tolerated', 'ALSFRS-R score', 'ALSFRS-R and VC scores', 'vital capacity (VC) change from baseline and percentage of participants showing no decline of ALSFRS-R score', 'ALSFRS-R scores, or VC', 'number of non-progressors']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",138.0,0.43627,"NP001, a regulator of macrophage activation, was associated with slowing disease progression in those with higher levels of plasma inflammatory marker, C-reactive protein (CRP), in phase 2A studies in ALS.","[{'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Miller', 'Affiliation': 'California Pacific Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Rongzhen', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Paige M', 'Initials': 'PM', 'LastName': 'Bracci', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Azhir', 'Affiliation': 'Neuvivo, Inc., Palo Alto, California, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Barohn', 'Affiliation': 'University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bedlack', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Cudkowicz', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kasarskis', 'Affiliation': 'University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mitsumoto', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Manousakis', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walk', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Oskarsson', 'Affiliation': 'Department of Neurology, Mayo Clinic, Florida, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Shefner', 'Affiliation': 'Barrow Neurological Institute, University of Arizona College of Medicine Phoenix, Creighton University College of Medicine Phoenix, Phoenix, Arizona, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'McGrath', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, California, USA.'}]",Muscle & nerve,['10.1002/mus.27511']
399,35112456,Mediators of the effects of canagliflozin on N-terminal pro-brain natriuretic peptide concentration: An exploratory mediation analysis of the randomized CANDLE trial.,,2022,,[],['canagliflozin'],[],[],"[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}]",[],,0.11457,,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Department of Medical Statistics, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, Yokohama Minami Kyosai Hospital, Yokohama, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Hiramitsu', 'Affiliation': 'Hiramitsu Heart Clinic, Nagoya, Japan.'}, {'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology and Clinical Examination, Oita University Faculty of Medicine, Yufu, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kadokami', 'Affiliation': 'Department of Cardiovascular Medicine, Saiseikai Futsukaichi Hospital, Chikushino, Japan.'}, {'ForeName': 'Arihiro', 'Initials': 'A', 'LastName': 'Kiyosue', 'Affiliation': 'Department of Cardiology, Moriyama Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Division of Cardiology, Osaka Rosai Hospital, Sakai, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14656']
400,35112665,Clonidine is better than zopiclone for insomnia treatment in chronic pain patients.,"STUDY OBJECTIVES


Chronic pain is associated with insomnia. The objective of this clinical study was to compare the efficacy and safety of different prescribed doses of zopiclone and clonidine for the management of insomnia in patients with chronic pain.
METHODS


This prospective observational crossover study included 160 consenting adult patients receiving pain management treatment. For insomnia treatment, each patient ingested different prescribed doses of zopiclone or clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using a numeric pain rating scale. Sleep score was measured using the Likert Sleep Scale. A change in the pain or sleep scores by 2 points was considered significant. Of the 160 study participants, 150 (93.8%) completed the study successfully, and their data were analyzed with IBM SPSS Statistics 25 (IBM Corporation, Armonk, NY) using Student's  t  test, analysis of variance, Pearson chi-square test, and regression analysis. A  P  value < .05 was considered significant.
RESULTS


Pain score was lower with clonidine than zopiclone ( P  = .025). Time to fall asleep was shorter with clonidine than zopiclone ( P  = .001). Feeling rested on waking in the morning was better with clonidine than zopiclone ( P  = .015). Overall sleep quality was better with clonidine than zopiclone ( P  = .015). Total Likert sleep score was better with clonidine than zopiclone ( P  = .005). Total sleep duration was better with clonidine than zopiclone ( P  = .013). Adverse effects were commoner with zopiclone, including collapse, fall, confusion, amnesia, mood disorder, hallucination, nightmare, nocturnal restlessness, locomotor dysfunction, nausea and headache. A minor adverse effect of dry mouth was commoner with clonidine.
CONCLUSIONS


Clonidine is significantly better than zopiclone with respect to sleep quality, analgesia, tolerability profile, and patient safety. Further studies comparing clonidine with other insomnia medications will be beneficial.
CITATION


Bamgbade OA, Tai-Osagbemi J, Bamgbade DO, et al. Clonidine is better than zopiclone for insomnia treatment in chronic pain patients.  J Clin Sleep Med . 2022;18(6):1565-1571.",2022,Time to fall asleep was shorter with clonidine than zopiclone (p=0.001).,"['patients with chronic pain', '160 study participants, 150 (93.8%) completed the study successfully; and their data were analyzed', 'chronic pain patients', '160 consenting adult patients who underwent pain management']","['zopiclone', 'clonidine', 'zopiclone or clonidine', 'zopiclone and clonidine', 'Clonidine']","['Pain', 'Overall sleep quality', 'Total sleep duration', 'Adverse effects', 'efficacy and safety', 'Sleep score', 'Time to fall asleep', 'Likert sleep scale', 'Feeling rested on waking', 'sleep quality, analgesia, tolerability profile, and patient safety', 'collapse, fall, confusion, amnesia, mood disorder, hallucination, nightmare, nocturnal restlessness, locomotor dysfunction, hunger, nausea and headache', 'Pain score', 'pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects', 'pain or sleep scores', 'Total Likert sleep score', 'IBM SPSS Statistics 25 (IBM Corp, Armonk, NY', 'numeric pain rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0078847', 'cui_str': 'zopiclone'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",160.0,0.101294,Time to fall asleep was shorter with clonidine than zopiclone (p=0.001).,"[{'ForeName': 'Olumuyiwa A', 'Initials': 'OA', 'LastName': 'Bamgbade', 'Affiliation': 'Department of Anesthesiology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jemima', 'Initials': 'J', 'LastName': 'Tai-Osagbemi', 'Affiliation': 'Research Department, Salem Anesthesia Pain Clinic Surrey, Vancouver, BC, Canada.'}, {'ForeName': 'Daniel O', 'Initials': 'DO', 'LastName': 'Bamgbade', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Ofeoritse', 'Initials': 'O', 'LastName': 'Murphy-Akpieyi', 'Affiliation': 'Department of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Abisola', 'Initials': 'A', 'LastName': 'Fadire', 'Affiliation': 'Department of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Nikki K', 'Initials': 'NK', 'LastName': 'Soni', 'Affiliation': 'Department of Pharmacy, Mathari National Teaching Hospital, Nairobi, Kenya.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Mumporeze', 'Affiliation': 'Department of Critical Care Medicine, University of Rwanda, Kigali, Rwanda.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9930']
401,35112424,The shared uncertainty experience of older adults with advanced cancer and their caregivers.,"OBJECTIVE


One primary source of psychological distress in patients with cancer and their caregivers is uncertainty. However, the uncertainty trajectory and its relationship between older adults with advanced cancer and their caregivers have rarely been examined. This study describes the uncertainty trajectory in patient-caregiver dyads, explores the effect of geriatric assessment (GA) intervention on trajectory, and examines the interdependent relationship of uncertainty.
METHODS


This secondary analysis used longitudinal data from a national cluster-randomized controlled trial examining a GA intervention compared to usual care. Participants completed the modified 9-item Mishel Uncertainty in Illness Scale at enrollment, 4-6 weeks, 3 months, and 6 months. The dyadic growth model and cross-lagged actor-partner interdependence model were used.
RESULTS


A total of 397 dyads (patient age M = 76.81 ± SD5.43; caregiver age M = 66.69 ± SD12.52) were included. Both had a trend of decreased uncertainty over time (b = -0.16, p < 0.01). There was a greater decrease in uncertainty among caregivers in the GA group than those in the usual care group (b = -0.46, p = 0.02). For both patients and caregivers, their past uncertainty was a significant predictor of their own current uncertainty (i.e., actor effect, p < 0.01). The individual's past uncertainty was a significant predictor of the other dyad member's current uncertainty (i.e., partner effect, p < 0.05), indicating an interdependent relationship between patient and caregiver uncertainty over time.
CONCLUSIONS


Findings suggest patient and caregiver function as a unit with uncertainty levels affecting each other. Future interventions could build on GA to address uncertainty for older patients with advanced cancer and caregivers.",2022,"There was a greater decrease in uncertainty among caregivers in the GA group than those in the usual care group (b=-0.46, p=.02).","['older patients with advanced cancer and caregivers', 'older adults with advanced cancer and their caregivers', 'A total of 397 dyads (patient age M=76.81 ± SD5.43; caregiver age M=66.69 ± SD12.52) were included', 'patient-caregiver dyads', 'patients with cancer and their caregivers', 'older patients with cancer', '2,8-10', '12,15,16', '11,12', 'older patients', '13,14']","['geriatric assessment (GA) intervention', 'GA intervention']","['modified 9-item Mishel Uncertainty in Illness Scale', 'quality of life', 'quality of life, and distress', 'quality of life and poor psychological adjustment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0557904', 'cui_str': 'Emotional adjustment'}]",397.0,0.0948158,"There was a greater decrease in uncertainty among caregivers in the GA group than those in the usual care group (b=-0.46, p=.02).","[{'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Mohile', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Norton', 'Affiliation': 'School of Nursing, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Sindhuja', 'Initials': 'S', 'LastName': 'Kadambi', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Kehoe', 'Affiliation': 'Department of Surgery, Cancer Control, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Aarne Grossman', 'Affiliation': 'SCOREboard Patient and Caregiver Advocacy Group, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Vogel', 'Affiliation': 'Geisinger Cancer Institute NCORP, Danville, Pennsylvania, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Burnette', 'Affiliation': 'Cancer Research of Wisconsin and Northern Michigan, Green Bay, Wisconsin, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Bradley', 'Affiliation': 'Northwell Health NCORP, New Hyde Park, New York, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester Medical Center, Rochester, New York, USA.'}]",Psycho-oncology,['10.1002/pon.5895']
402,35125253,Community coalition and key stakeholder perceptions of the community opioid epidemic before an intensive community-level intervention.,"INTRODUCTION


Opioid overdoses are a major public health emergency in the United States. Despite effective treatments that can save lives, access to and utilization of such treatments are limited. Community context plays an important role in addressing treatment barriers and increasing access. The HEALing Communities Study (HCS) is a multisite community-level cluster-randomized trial that will study implementation and outcomes of a community coalition-based intervention (Communities that HEAL [CTH]) that implements evidence-based practices (EBPs) to reduce opioid overdose deaths in four states. To examine contextual factors critical to understanding implementation, we assessed the perspectives of community members about their communities, current substance use-related services, and other important issues that could impact intervention implementation.
METHODS


Researchers conducted 382 semi-structured qualitative interviews in the HCS communities. Interviews were audio-recorded and transcribed; researchers subsequently analyzed data using directed content analysis based on the constructs of the RE-AIM/PRISM implementation science framework to identify key themes within the external community context.
RESULTS


Despite the diversity in states and communities, four similar themes related to the external community context emerged across communities: These themes included the importance of understanding: 1) community risk perceptions, 2) levels of stigma, 3) the health services environment and the availability of substance use services, and 4) funding for substance use services.
CONCLUSION


Understanding and addressing the external community context in which the CTH intervention and EBPs are implemented are crucial for successful health services-related and community engaged interventions. While implementing EBPs is a challenging undertaking, doing so will help us to understand if and how a community-based intervention can successfully reduce opioid overdose deaths and influence both community beliefs and the community treatment landscape.",2022,"Despite the diversity in states and communities, four similar themes related to the external community context emerged across communities: These themes included the importance of understanding: 1) community risk perceptions, 2) levels of stigma, 3) the health services environment and the availability of substance use services, and 4) funding for substance use services.
",['Researchers conducted 382 semi-structured qualitative interviews in the HCS communities'],['community coalition-based intervention (Communities that HEAL [CTH'],[],"[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.0371834,"Despite the diversity in states and communities, four similar themes related to the external community context emerged across communities: These themes included the importance of understanding: 1) community risk perceptions, 2) levels of stigma, 3) the health services environment and the availability of substance use services, and 4) funding for substance use services.
","[{'ForeName': 'Mari-Lynn', 'Initials': 'ML', 'LastName': 'Drainoni', 'Affiliation': 'Boston Medical Center/Boston University, 801 Massachusetts Avenue, Boston, MA 02118, USA. Electronic address: drainoni@bu.edu.'}, {'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Knudsen', 'Affiliation': 'University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Adams', 'Affiliation': 'University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Shaquita A', 'Initials': 'SA', 'LastName': 'Andrews-Higgins', 'Affiliation': 'University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Auritt', 'Affiliation': 'Boston Medical Center, 801 Massachusetts Avenue, Boston, MA 02118, USA.'}, {'ForeName': 'Sandi', 'Initials': 'S', 'LastName': 'Back', 'Affiliation': 'University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barkowski', 'Affiliation': 'Boston Medical Center, 801 Massachusetts Avenue, Boston, MA 02118, USA.'}, {'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Batty', 'Affiliation': 'University of Kentucky, 1522 Patterson Office Tower, Lexington, KY 40506, USA.'}, {'ForeName': 'Melika R', 'Initials': 'MR', 'LastName': 'Behrooz', 'Affiliation': 'Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Ohio State University, 460 Medical Center Drive, Columbus, OH 43210, USA.'}, {'ForeName': 'Mia-Cara', 'Initials': 'MC', 'LastName': 'Christopher', 'Affiliation': 'Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Coovert', 'Affiliation': 'Ohio State University, 460 Medical Center Drive, Columbus, OH 43210, USA.'}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Crable', 'Affiliation': 'University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA.'}, {'ForeName': 'Anindita', 'Initials': 'A', 'LastName': 'Dasgupta', 'Affiliation': 'Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Goetz', 'Affiliation': 'University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Goddard-Eckrich', 'Affiliation': 'Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.'}, {'ForeName': 'Jeanie L', 'Initials': 'JL', 'LastName': 'Hartman', 'Affiliation': 'University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Heffer', 'Affiliation': 'Ohio State University, 460 Medical Center Drive, Columbus, OH 43210, USA.'}, {'ForeName': 'Pulwasha', 'Initials': 'P', 'LastName': 'Iftikhar', 'Affiliation': 'City University of New York, 55 West 125 Street, New York, NY 10027, USA.'}, {'ForeName': 'Latasha', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Lunze', 'Affiliation': 'Boston Medical Center/Boston University, 801 Massachusetts Avenue, Boston, MA 02118, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Boston Medical Center, 801 Massachusetts Avenue, Boston, MA 02118, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McCrimmon', 'Affiliation': 'Columbia University, 1255 Amsterdam Avenue, New York, NY 10027, USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Reedy-Johnson', 'Affiliation': 'University of Kentucky, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Roeber', 'Affiliation': 'Substance Abuse & Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857, USA.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Scalise', 'Affiliation': 'Boston Medical Center, 801 Massachusetts Avenue, Boston, MA 02118, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Sieck', 'Affiliation': 'Ohio State University, 460 Medical Center Drive, Columbus, OH 43210, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Walker', 'Affiliation': 'Ohio State University, 460 Medical Center Drive, Columbus, OH 43210, USA.'}, {'ForeName': 'Galya', 'Initials': 'G', 'LastName': 'Walt', 'Affiliation': 'Boston Medical Center, 801 Massachusetts Avenue, Boston, MA 02118, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Wood', 'Affiliation': 'Temple University, 1115 Polett Walk, Philadelphia, PA 19122, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Zito', 'Affiliation': 'City University of New York, 55 West 125 Street, New York, NY 10027, USA.'}, {'ForeName': 'Ann Scheck', 'Initials': 'AS', 'LastName': 'McAlearney', 'Affiliation': 'Ohio State University, 460 Medical Center Drive, Columbus, OH 43210, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2022.108731']
403,35123075,Reducing parental anxiety during oral food challenges: A randomized controlled trial of deep breathing exercises.,,2022,,[],['deep breathing exercises'],['parental anxiety'],[],"[{'cui': 'C0454496', 'cui_str': 'Deep breathing exercises'}]","[{'cui': 'C0577602', 'cui_str': 'Parental anxiety'}]",,0.251881,,"[{'ForeName': 'Chantel E', 'Initials': 'CE', 'LastName': 'Canessa', 'Affiliation': 'Division of Speciality Medicine, Department of Pediatrics, The University of British Columbia, Vancouver, Canada; Adjunct Faculty, School of Nursing, The University of British Columbia, Vancouver, Canada. Electronic address: ccanessa2@cw.bc.ca.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Soller', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, Canada; British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'To', 'Affiliation': ""Department of Psychology, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Newlove', 'Affiliation': ""Department of Psychology, British Columbia Children's Hospital, Vancouver, British Columbia, Canada; Department of Psychology, The University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Edmond S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, Canada; British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2022.01.029']
404,35123016,"Blinded, parallel and randomized clinical evaluation of in-office dental bleaching with violet LED (405-410nm).","This clinical study evaluated the effect of bleaching performed with violet LED light (405-410 nm), either combined with hydrogen peroxide (HP) gel, or not, on color change, dental sensitivity, participants' satisfaction and impact on their quality of life. A hundred participants were divided into one of the groups (n = 25): G1 - 35% HP (4 sessions, 1x/week); G2 - violet LED (4 sessions, 1x/week); G3 - violet LED (4 sessions, 2x/week); G4 - hybrid technique (violet LED + 35% HP; 4 sessions, 1x/week). Color evaluation was performed with colorimetric tests (objective and subjective), before, 14 days and 3 months after completion. Additionally, satisfaction with treatment, impact on quality of life (OHIP-14) and dental sensitivity were recorded. The data were submitted to statistical analysis, considering a significance level of 5%, with the exception of the data from the questionnaire on satisfaction (descriptive analysis). Two-way ANOVA and Tukey tests showed that there was no difference between color variation resulting from techniques used in G1 and G4; those used in G2 and G3 did not differ and were less effective for bleaching than those of the other groups, in both subjective and objective evaluations. Regarding tooth sensitivity, subjects in G2 and G3 experienced no sensitivity, ​​while those in G4 showed lower sensitivity values than those in G1. With respect to quality of life, only subjects in G1 and G2 showed a significant positive impact. Among the evaluated techniques, the hybrid type seemed to be a good alternative, showing effective bleaching with less tooth sensitivity.",2022,"Two-way ANOVA and Tukey tests showed that there was no difference between color variation resulting from techniques used in G1 and G4; those used in G2 and G3 did not differ and were less effective for bleaching than those of the other groups, in both subjective and objective evaluations.",['A hundred participants were divided into one of the groups (n\u202f=\u202f25'],"['office Dental Bleaching with Violet LED', 'bleaching performed with violet LED light (405-410 nm), either combined with hydrogen peroxide (HP) gel', 'G2 - violet LED', 'G1 - 35% HP', 'G3 - violet LED (4 sessions, 2x/week); G4 - hybrid technique (violet LED\u202f+\u202f35% HP']","['quality of life (OHIP-14) and dental sensitivity', 'quality of life', 'sensitivity values']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",0.0,0.0147361,"Two-way ANOVA and Tukey tests showed that there was no difference between color variation resulting from techniques used in G1 and G4; those used in G2 and G3 did not differ and were less effective for bleaching than those of the other groups, in both subjective and objective evaluations.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Mayer-Santos', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil. Electronic address: eric.mayer.santos@alumni.usp.br.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bachiega-Silva', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil.'}, {'ForeName': 'Caroline Vale', 'Initials': 'CV', 'LastName': 'Twiaschor', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil.'}, {'ForeName': 'Carlos Alberto Kenji', 'Initials': 'CAK', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil.'}, {'ForeName': 'Giovanna Bueno', 'Initials': 'GB', 'LastName': 'Marinho', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil.'}, {'ForeName': 'Aldo Brugnera', 'Initials': 'AB', 'LastName': 'Junior', 'Affiliation': 'Brugnera and Zanin Institute; São Paulo, Brazil.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Zanin', 'Affiliation': 'Brugnera and Zanin Institute; São Paulo, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Brugnera', 'Affiliation': 'Brugnera and Zanin Institute; São Paulo, Brazil.'}, {'ForeName': 'Karen Muller', 'Initials': 'KM', 'LastName': 'Ramalho', 'Affiliation': 'Ibirapuera University, São Paulo, Brazil.'}, {'ForeName': 'Patricia Moreira', 'Initials': 'PM', 'LastName': 'de Freitas', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil. Electronic address: pfreitas@usp.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2022.102739']
405,35122668,"Effect of Oral Vitamin D3 Supplementation in Exclusively Breastfed Newborns: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.","Exclusively breastfed infants are at a high risk of vitamin D deficiency. Few studies have evaluated the effects of vitamin D supplementation. Hence, we conducted a prospective randomized controlled trial investigating the effects of oral vitamin D3 400 IU/d supplementation in exclusively breastfed newborns. Serum 25-hydroxy-vitamin D (25[OH]D) levels in pregnant women and their newborns were evaluated. Breastfed newborns were randomized to one of two regimens at age 10 days. One group received vitamin D3 supplementation at a dose of 400 IU/d (vD-400 group), whereas the placebo group received a liquid product without vitamin D3. Outcomes were assessed at 4 months of age. A total of 92 pregnant women and their infants were enrolled, and the data of 72 infants (37 in the vD-400 group and 35 in the placebo group) who completed the study at 4 months of age were assessed. The results showed severe vitamin D deficiency in 15.2% of mothers before delivery, while 54.3% had vitamin D deficiency. Moreover, 15.2% of newborns presented with severe vitamin D deficiency at birth, while 52.2% had vitamin D deficiency. Maternal vitamin D levels were significantly correlated with infant vitamin D levels at birth (r = 0.816, p < 0.001). At 4 months of age, weight, head circumference, serum 25(OH)D, phosphorus, and intact parathyroid hormone levels significantly differed between the vD-400 and placebo groups. However, the body length and bone mineral density of the two groups did not differ significantly. Regardless of vitamin D supplementation, participants with severe vitamin D deficiency had significantly higher intact parathyroid hormone levels and lower bone mineral content. In conclusion, among exclusively breastfed infants, oral supplementation with vitamin D3 at a dose of 400 IU/d from age 10 days increased 25(OH)D concentrations at 4 months of age, but it did not affect bone mineralization. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).",2022,"Regardless of vitamin D supplementation, participants with severe vitamin D deficiency had significantly higher intact parathyroid hormone levels and lower bone mineral content.","['exclusively breastfed newborns', 'participants with severe vitamin D deficiency', 'Exclusively Breastfed Newborns', '92 pregnant women and their infants were enrolled, and the data of 72 infants (37 in the vD-400 group and 35 in the placebo group) who completed the study at 4 months of age, were assessed', 'pregnant women and their newborns', 'Breastfed newborns']","['placebo', 'vitamin D3', 'liquid product without vitamin D3', 'Placebo', 'oral vitamin D3 400 IU/d supplementation', 'Oral Vitamin D3 Supplementation', 'vitamin D3 supplementation', 'vitamin D supplementation']","['body length and bone mineral density', 'bone mineralization', 'Serum 25-hydroxy-vitamin D (25[OH]D) levels', '25(OH)D concentrations', 'severe vitamin D deficiency', 'Maternal vitamin D levels', 'intact parathyroid hormone levels and lower bone mineral content', 'weight, head circumference, serum 25(OH)D, phosphorus, and intact parathyroid hormone levels']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}]",92.0,0.379581,"Regardless of vitamin D supplementation, participants with severe vitamin D deficiency had significantly higher intact parathyroid hormone levels and lower bone mineral content.","[{'ForeName': 'Chao-Hsu', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Chien-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Sung', 'Affiliation': 'Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Sung-Tse', 'Initials': 'ST', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Bi-Wen', 'Initials': 'BW', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Shun-Long', 'Initials': 'SL', 'LastName': 'Weng', 'Affiliation': 'Department of Obstetrics and Gynecology, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Shing-Jyh', 'Initials': 'SJ', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Hung-Chang', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': ""Department of Pediatrics, MacKay Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Yann-Jinn', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, MacKay Medical College, New Taipei, Taiwan.'}, {'ForeName': 'Wei-Hsin', 'Initials': 'WH', 'LastName': 'Ting', 'Affiliation': 'Department of Medicine, MacKay Medical College, New Taipei, Taiwan.'}, {'ForeName': 'Hung-Yang', 'Initials': 'HY', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, MacKay Medical College, New Taipei, Taiwan.'}, {'ForeName': 'Yi-Lei', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Department of Pediatrics, Changhua Christian Children's Hospital, Changhua, Taiwan.""}, {'ForeName': 'Chih-Sheng', 'Initials': 'CS', 'LastName': 'Lin', 'Affiliation': 'Department of Biological Science and Technology, National Yang Ming Chiao Tung University, Hsinchu, Taiwan.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4521']
406,35124734,Age-stratified outcomes after radical prostatectomy in a randomized setting (LAP-01): do younger patients have more to lose?,"OBJECTIVE


Age is known to have an impact on outcomes after radical prostatectomy (RP). However, age differences can be investigated from a cross-sectional as well as from a longitudinal perspective. This study combines both perspectives.
MATERIALS AND METHODS


LAP-01 is the first multicenter randomized patient blinded trial comparing outcomes after robotic-assisted and laparoscopic RP. This study stratified the entire population that received nerve-sparing surgery and was potent at baseline by the following ages: ≤ 60 years, 61-65 years, and > 65 years. Potency was assessed using the IIEF-5. The EORTC QLQ-C30 was used for global health perception and the EORTC QLQ-PR25 for urinary symptoms. Continence was assessed by the number of pads used. Longitudinal change was assessed using either validated anchor-based criteria or the 1 or 0.5-standard-deviation criterion. Worsening of continence was measured by increasing numbers of pads.
RESULTS


310 patients were included into this study. Older patients had a significantly higher risk for worsening of continence at 3 and 6 months (OR 2.21, 95% CI [1.22, 4.02], p = 0.009 and OR 2.00, 95% CI [1.16, 3.46], p = 0.013, respectively); at 12 months, the odds of worsening did not differ significantly between age groups. Potency scores were better in younger patients from a cross-sectional perspective, but longitudinal change did not differ between the age groups. In contrast, global health perception was better in older patients from a cross-sectional perspective and longitudinal decreases were significantly more common among the youngest patients, at 12 months (36.9% vs. 24.4%, p = 0.038).
CONCLUSION


From a cross-sectional perspective, function scores were better in younger patients, but from a longitudinal perspective, age differences were found in continence only. In contrast, global health scores were better in older patients from a cross-sectional and longitudinal perspective.
TRIAL REGISTRATION


The LAP-01 trial was registered with the U.S. National Library of Medicine clinical trial registry (clinicaltrials.gov), NCT number: NCT03682146, and with the German Clinical Trial registry (Deutsches Register Klinischer Studien), DRKS ID number: DRKS00007138.",2022,"Potency scores were better in younger patients from a cross-sectional perspective, but longitudinal change did not differ between the age groups.","['310 patients were included into this study', 'Older patients']","['radical prostatectomy in a randomized setting (LAP-01', 'nerve-sparing surgery', 'radical prostatectomy (RP', 'robotic-assisted and laparoscopic RP']","['Potency scores', 'Worsening of continence', 'global health perception', 'Continence', 'worsening of continence', 'global health scores', 'numbers of pads']","[{'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332568', 'cui_str': 'Pad'}]",310.0,0.120094,"Potency scores were better in younger patients from a cross-sectional perspective, but longitudinal change did not differ between the age groups.","[{'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Holze', 'Affiliation': 'Department of Urology, University of Leipzig, Liebigstraße 20, 04103, Leipzig, Germany. sigrun.holze@medizin.uni-leipzig.de.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bräunlich', 'Affiliation': 'Department of Urology, University of Leipzig, Liebigstraße 20, 04103, Leipzig, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Mende', 'Affiliation': 'University of Leipzig, Clinical Trial Centre Leipzig, Härtelstraße 16-18, 04107, Leipzig, Germany.'}, {'ForeName': 'Vinodh-Kumar-Adithyaa', 'Initials': 'VK', 'LastName': 'Arthanareeswaran', 'Affiliation': 'Department of Urology, University of Leipzig, Liebigstraße 20, 04103, Leipzig, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Neuhaus', 'Affiliation': 'University of Leipzig, Clinical Trial Centre Leipzig, Härtelstraße 16-18, 04107, Leipzig, Germany.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Truss', 'Affiliation': 'Department of Urology, Klinikum Dortmund, Beurhausstr. 40, 44137, Dortmund, Germany.'}, {'ForeName': 'Hoang Minh', 'Initials': 'HM', 'LastName': 'Do', 'Affiliation': 'Department of Urology, University of Leipzig, Liebigstraße 20, 04103, Leipzig, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Dietel', 'Affiliation': 'Department of Urology, University of Leipzig, Liebigstraße 20, 04103, Leipzig, Germany.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Franz', 'Affiliation': 'Department of Urology, University of Leipzig, Liebigstraße 20, 04103, Leipzig, Germany.'}, {'ForeName': 'Dogu', 'Initials': 'D', 'LastName': 'Teber', 'Affiliation': 'Department of Urology, University of Heidelberg, Im Neuenheimer Feld 672, 69120, Heidelberg, Germany.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Heilsberg', 'Affiliation': 'Department of Urology, Klinikum Dortmund, Beurhausstr. 40, 44137, Dortmund, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hohenfellner', 'Affiliation': 'Department of Urology, University of Heidelberg, Im Neuenheimer Feld 672, 69120, Heidelberg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rabenalt', 'Affiliation': 'Department of Urology, University of Duesseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Albers', 'Affiliation': 'Department of Urology, University of Duesseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Stolzenburg', 'Affiliation': 'Department of Urology, University of Leipzig, Liebigstraße 20, 04103, Leipzig, Germany.'}]",World journal of urology,['10.1007/s00345-022-03945-0']
407,35115225,Single-Injection Midpoint Transverse Process-to- Pleura Block Versus Thoracic Paravertebral Block for Postoperative Analgesia After Uniportal Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial.,"OBJECTIVES


The effect of midpoint transverse process-to-pleura block (MTPB) is unclear. The authors compared the analgesic characteristics of MTPB with those of thoracic paravertebral nerve block (TPVB) in patients undergoing uniportal video-assisted thoracoscopic surgery (uVATS) and examined the 2 types of blocks for noninferiority.
DESIGN


A randomized, controlled trial.
SETTING


A single-institution, university hospital.
PARTICIPANTS


The study comprised 82 patients between 18 and 75 years of age. Eighty-one patients were included for final analysis.
INTERVENTIONS


Patients were randomly allocated to either the MTPB group (Group M) or the TPVB group (Group P).
MEASUREMENTS AND MAIN RESULTS


The primary outcome was the mean difference in the postoperative visual analog scale (VAS) score between Group M and Group P at rest and at 12 hours. The secondary outcomes included VAS scores during rest and coughing, nerve block performance, intraoperative consumption of anesthetics and vasoactive medication, time at first use of patient-controlled intravenous analgesia (PCIA), number of uses of PCIA, consumption of sufentanil in PCIA, and side effects. The mean difference in VAS score in the MTPB and TPVB group at rest and 12 hours postoperatively was 0.5 (95% confidence interval, -0.26 to 0.36). There was no significant difference in the time at first use of PCIA, which was 12 (10, 12) hours and 11 (10, 12) hours in Group M and Group P, respectively. The depth of puncture was shallower, and the time to perform block was shorter in Group M compared with Group P (p < 0.001).
CONCLUSIONS


The analgesic effect of single-level-injection MTPB is noninferior to that of TPVB in patients undergoing uVATS. The target point of the needle in MTPB is shallower and farther away from the pleura compared with TPVB. For these reasons, it is quicker and safer and, thus, may be preferable.",2022,"The depth of puncture was shallower, and the time to perform block was shorter in Group M compared with Group P (p < 0.001).
","['82 patients between 18 and 75 years of age', 'Eighty-one patients were included for final analysis', 'patients undergoing', 'patients undergoing uVATS', 'A single-institution, university hospital']","['thoracic paravertebral nerve block (TPVB', 'Uniportal Video-Assisted Thoracoscopic Surgery', 'uniportal video-assisted thoracoscopic surgery (uVATS', 'Pleura Block Versus Thoracic Paravertebral Block for Postoperative Analgesia', 'midpoint transverse process-to-pleura block (MTPB', 'MTPB', 'Single-Injection Midpoint Transverse Process-to', 'TPVB']","['VAS score', 'VAS scores during rest and coughing, nerve block performance, intraoperative consumption of anesthetics and vasoactive medication, time at first use of patient-controlled intravenous analgesia (PCIA), number of uses of PCIA, consumption of sufentanil in PCIA, and side effects', 'postoperative visual analog scale (VAS) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4304660', 'cui_str': 'Uniportal VATS - video assisted thoracoscopic surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia'}, {'cui': 'C4304660', 'cui_str': 'Uniportal VATS - video assisted thoracoscopic surgery'}, {'cui': 'C0032225', 'cui_str': 'Pleural structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.381889,"The depth of puncture was shallower, and the time to perform block was shorter in Group M compared with Group P (p < 0.001).
","[{'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Jinjing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China. Electronic address: 867642981@qq.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2021.12.036']
408,35121623,Clinical Significance of PIK3CA and ESR1 Mutations in Circulating Tumor DNA: Analysis from the MONARCH 2 Study of Abemaciclib plus Fulvestrant.,"PURPOSE


PIK3CA and ESR1 mutations have been implicated in resistance to endocrine therapy (ET) in HR+, HER2- advanced breast cancer (ABC). Inhibition of CDK4 and 6 has been hypothesized as a therapeutic strategy to overcome endocrine resistance in patients with PIK3CA- or ESR1-mutant breast cancers. The objective of this exploratory analysis was to assess efficacy of abemaciclib plus fulvestrant in patients with or without PIK3CA or ESR1 mutations in MONARCH 2.
PATIENTS AND METHODS


MONARCH 2 was a global, randomized, double-blind phase III trial of abemaciclib plus fulvestrant in 669 women with HR+, HER2- ABC, which had progressed on ET. Patients were randomized 2:1 to receive abemaciclib plus fulvestrant or placebo plus fulvestrant. Exploratory analyses assessed progression-free survival (PFS) and overall survival (OS), and other endpoints, in patients with or without PIK3CA or ESR1 mutations detectable in baseline ctDNA.
RESULTS


From the MONARCH 2 population, 219 and 248 patient samples were successfully analyzed for either PIK3CA or ESR1 mutations, respectively. Abemaciclib plus fulvestrant improved PFS compared with placebo plus fulvestrant in both PIK3CA-wild-type (median 16.9 months vs. 12.3 months; HR, 0.51; 95% CI, 0.33-0.78) and PIK3CA-mutant subgroups (median 17.1 months vs. 5.7 months; HR, 0.53; 95% CI, 0.33-0.84), as well as both ESR1-wild-type (median 15.3 months vs. 11.2 months; HR, 0.44; 95% CI, 0.27-0.71) and ESR1-mutant subgroups (median 20.7 months vs. 13.1 months; HR, 0.54; 95% CI, 0.37-0.79). Additional endpoints, including OS, were also improved following treatment with abemaciclib plus fulvestrant regardless of PIK3CA or ESR1 mutation status.
CONCLUSIONS


Abemaciclib plus fulvestrant was effective regardless of PIK3CA or ESR1 mutation status, with benefit in both PFS and OS, with a numerically greater improvement in median PFS relative to placebo plus fulvestrant for PIK3CA- or ESR1-mutant tumors compared with the respective wild-type subgroups, in women with HR+, HER2- ABC that had progressed on ET.",2022,"RESULTS


Abemaciclib plus fulvestrant improved PFS compared to placebo plus fulvestrant in both  PIK3CA -wild-type and  PIK3CA -mutant subgroups, as well as both  ESR1 -wild-type and  ESR1","['patients with or without  PIK3CA  or  ESR1  mutations detectable in baseline ctDNA', 'patients with  PIK3CA - or  ESR1 -mutant breast cancers', 'women with HR+, HER2- ABC that had progressed on ET', 'patients with or without  PIK3CA  or  ESR1  mutations in MONARCH 2', 'circulating tumor DNA']","['abemaciclib plus fulvestrant or placebo plus fulvestrant', 'Abemaciclib plus fulvestrant', 'placebo plus fulvestrant', 'abemaciclib plus fulvestrant', 'CDK4&6']","['PFS', 'median PFS', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.261373,"RESULTS


Abemaciclib plus fulvestrant improved PFS compared to placebo plus fulvestrant in both  PIK3CA -wild-type and  PIK3CA -mutant subgroups, as well as both  ESR1 -wild-type and  ESR1","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': 'Universitatsklinikum Tubingen Frauenklinik, Tubingen, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Llombart-Cussac', 'Affiliation': 'Hospital Arnau Vilanova, Valencia, Spain.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Soliman', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Wijayawardana', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Jansen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Lacey M', 'Initials': 'LM', 'LastName': 'Litchfield', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University, Stanford, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-3276']
409,35128627,"Gingival irritation in patients submitted to at-home bleaching with different cutouts of the bleaching tray: a randomized, single-blind clinical trial.","OBJECTIVES


This split-mouth randomized, single-blind clinical trial evaluated the gingival irritation (GI) of at-home bleaching with individual trays of different cutouts, as well as the tooth sensitivity (TS) and color change.
MATERIALS AND METHODS


One hundred and twenty patients were randomized as to which side would receive the type of bleaching tray cutout: scalloped (in the gingival margin) and nonscalloped (extended from the gingival margin). The at-home bleaching was performed for 30 min with 10% hydrogen peroxide (HP) for 2 weeks. The absolute risk and intensity of GI and TS were assessed with a visual analog scale. Color change was assessed using a digital spectrophotometer and a color guide (α = 0.05).
RESULTS


The proportion of patients who experienced GI was 57.5% (odds ratio 95% CI = 1.1 [0.7 to 1.8]), with no significant difference between groups (p = 0.66). The proportion of patients who experienced TS was 64.1% (odds ratio 95% CI = 1.0 [0.6 to 1.6]), with no significant difference between groups (p = 1.0). There is equivalence of scalloped and noscalloped groups for GI intensity (p < 0.01). Significant whitening was detected for both groups. Although some differences were observed between groups (CIEL ab  and CIEDE 00 ; p < 0.02), these were below of the considered clinically noticeable.
CONCLUSIONS


The different cutouts of trays proved to be equivalent when regarding gengival irritation and tooth sensitivity when 10% HP for at-home bleaching was used. Significant color change was observed in both groups. However, significant differences detected between groups are not considered clinically noticeable.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry (RBR-2s34685).
CLINICAL RELEVANCE


Scalloped or not, the individual trays for at-home bleaching could be considered a clinician's decision.",2022,There is equivalence of scalloped and noscalloped groups for GI intensity (p < 0.01).,['One hundred and twenty patients'],"['bleaching tray cutout: scalloped (in the gingival margin) and nonscalloped (extended from the gingival margin', 'hydrogen peroxide (HP']","['gingival irritation (GI', 'Gingival irritation', 'tooth sensitivity (TS) and color change', 'absolute risk and intensity of GI and TS', 'gengival irritation and tooth sensitivity']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0454147', 'cui_str': 'Cutout'}, {'cui': 'C0324026', 'cui_str': 'Scallop'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",120.0,0.127782,There is equivalence of scalloped and noscalloped groups for GI intensity (p < 0.01).,"[{'ForeName': 'Taynara S', 'Initials': 'TS', 'LastName': 'Carneiro', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, Ponta Grossa, PR, 84030-900, Brazil.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Favoreto', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, Ponta Grossa, PR, 84030-900, Brazil.'}, {'ForeName': 'Laís G', 'Initials': 'LG', 'LastName': 'Bernardi', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, Ponta Grossa, PR, 84030-900, Brazil.'}, {'ForeName': 'Elisama', 'Initials': 'E', 'LastName': 'Sutil', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, Ponta Grossa, PR, 84030-900, Brazil.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wendlinger', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, Ponta Grossa, PR, 84030-900, Brazil.'}, {'ForeName': 'Gabrielle G', 'Initials': 'GG', 'LastName': 'Centenaro', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, Ponta Grossa, PR, 84030-900, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, Ponta Grossa, PR, 84030-900, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, Ponta Grossa, PR, 84030-900, Brazil. aloguercio@hotmail.com.'}]",Clinical oral investigations,['10.1007/s00784-022-04401-4']
410,35130185,"Comment on ""Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial"".",,2022,,['Painful Chronic Pancreatitis'],['Internet Cognitive-Behavioral Therapy'],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.104417,,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Naval Military Medical University, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Yan-Wei', 'Initials': 'YW', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Liang-Hao', 'Initials': 'LH', 'LastName': 'Hu', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000439']
411,35125434,Usage Patterns of an mHealth Symptom Monitoring App Among Adolescents With Acute Mild Traumatic Brain Injuries.,"OBJECTIVE


To understand usage patterns of SMART (Self-Monitoring Activity Regulation and Relaxation Treatment) mHealth app among adolescents with acute mild traumatic brain injuries (mTBIs) and to identify individual characteristics that influenced app usage.
METHODS



SETTING


Emergency departments of tertiary care children's medical center.
PARTICIPANTS


Children aged 11 to 18 years with mTBI in the past 2 weeks, English-speaking, no evidence of severe TBI, and no preexisting neurological impairment.
DESIGN


Nested cohort of the intervention arm of a randomized clinical trial (n = 34).
MHEALTH APP INTERVENTION


SMART was a month-long educational program on mTBI designed to promote self-monitoring and management of recovery. SMART included digital symptom and activity self-monitoring surveys, feedback on symptom changes, and 8 modules providing psychoeducation, strategies for symptom management, and training in active problem solving.
MAIN MEASURES


App usage time, navigation, and interaction data were automatically collected. Usage involved inputting symptom ratings/activities and reviewing modules. Patterns of symptom/activity reporting and completion of learning modules data were analyzed. Predictors of app utilization, including individual characteristics, resilience (Connor-Davidson Resilience Scale), and coping (Coping Strategies Inventory-Short Form), were analyzed using Spearman correlations.
RESULTS


Participants completed symptom monitoring an average of 9 days over the month. Participants completed an average of 1.87 learning modules out of 7. Parent income and education, comorbid attention-deficit/hyperactivity disorder (ADHD), and emotional engagement coping style predicted symptom monitoring. Parental income, comorbid ADHD, and greater reliance on emotional engagement coping predicted module completion.
SIGNIFICANT ADVERSE EVENTS


None.
CONCLUSION


Adolescents of higher socioeconomic status and those who manage their emotions using active engagement spent more time on both components of the SMART program.",2022,"SIGNIFICANT ADVERSE EVENTS


","[""Emergency departments of tertiary care children's medical center"", 'Children aged 11 to 18 years with mTBI in the past 2 weeks, English-speaking, no evidence of severe TBI, and no preexisting neurological impairment', 'Adolescents With Acute Mild Traumatic Brain Injuries', 'adolescents with acute mild traumatic brain injuries (mTBIs']","['SMART (Self-Monitoring Activity Regulation and Relaxation Treatment) mHealth app', 'mHealth Symptom Monitoring App']","['App usage time, navigation, and interaction data', 'individual characteristics, resilience (Connor-Davidson Resilience Scale), and coping (Coping Strategies Inventory-Short Form']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",34.0,0.0927096,"SIGNIFICANT ADVERSE EVENTS


","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': ""Educational Technology, College of Education, University of Florida, Gainesville (Dr Schmidt); Cincinnati Children's Hospital Medical Center (Drs Babcock, Kurowski, Cassedy, Sidol, and Wade), Division of Pediatric Rehabilitation Medicine (Drs Kurowski and Wade), and Departments of Pediatrics and Neurology and Rehabilitation Medicine (Dr Kurowski), University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Babcock', 'Affiliation': ''}, {'ForeName': 'Brad G', 'Initials': 'BG', 'LastName': 'Kurowski', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cassedy', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Sidol', 'Affiliation': ''}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000768']
412,35125305,Stromal vascular fraction improves the durability of autologous fat temple augmentation-A split-face randomized study using ultrasound biomicroscopy.,"BACKGROUND


Autologous lipotransfer aims to restore aging-associated volume loss, but with low predictability owing to 20-90% first-year loss of transferred fat. Enrichment by adipose-derived stem cells within the stromal vascular fraction (SVF) aims to improve volume retention through their differentiation potential and paracrine actions exerted by secreted trophic and angiogenic factors. Assessing studies lacked split-face designs, and used multitudes of enrichment ratios, preparation techniques and evaluation methods ending in contradictory reports regarding enrichment advantage.
AIM


To test whether enriching the autologous fat graft with SVF will increase its residual volume as compared to non-enriched graft. A standardized enrichment protocol and ratio and objective assessment were employed.
PATIENTS AND METHODS


In a split-face design, and after random assignment, bilateral temple augmentation using non-enriched versus SVF-enriched autologous lipotransfer were compared in middle-aged females otherwise healthy non-pregnant or breast-feeding females abstaining from esthetic or weight-controlling procedures. Temple volume scale (TVS), skin layers' thickness measured by ultrasound biomicroscopy (UBM), visual analog scale for patients' satisfaction, and side effects were blindly assessed at 1 week, 3 months, and 6 months.
RESULTS


In the included 15 females, TVS was significantly lower (0.5 ± 0.5 versus 1.1 ± 0.7, P = 0.0001), and% hypodermal augmentation was significantly higher (70.92 ± 58.09 versus 18.93 ± 19.33, P = 0.001) on the SVF-enriched side at 6 months. Patient satisfaction was similar bilaterally (P = 1), as were sequelae frequencies as lumping, edema, and ecchymosis.
CONCLUSION


SVF enrichment of transferred fat significantly improved its residual volume at 6 months; a conclusion that needs further validation. UBM was an informative objective tool for the following temple skin thickness changes. Trial registration clinical trials.gov (NCT03965936).",2022,"Patient satisfaction was similar bilaterally (P = 1), as were sequelae frequencies as lumping, edema, and ecchymosis.
",['middle-aged females otherwise healthy non-pregnant or breast-feeding females abstaining from esthetic or weight-controlling procedures'],"['UBM', 'bilateral temple augmentation using non-enriched versus SVF-enriched autologous lipotransfer', 'ultrasound biomicroscopy', 'Stromal vascular fraction']","['and% hypodermal augmentation', ""Temple volume scale (TVS), skin layers' thickness measured by ultrasound biomicroscopy (UBM), visual analog scale for patients' satisfaction, and side effects"", 'Patient satisfaction', 'sequelae frequencies as lumping, edema, and ecchymosis', 'TVS']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1301497', 'cui_str': 'Ultrasound biomicroscopy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1282402', 'cui_str': 'Skin layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301497', 'cui_str': 'Ultrasound biomicroscopy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",,0.0590566,"Patient satisfaction was similar bilaterally (P = 1), as were sequelae frequencies as lumping, edema, and ecchymosis.
","[{'ForeName': 'O H', 'Initials': 'OH', 'LastName': 'Roshdy', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Alexandria University, 106 Port Said street, Camp Cesar, Alexandria, Egypt.'}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Abdallah', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Alexandria University, 106 Port Said street, Camp Cesar, Alexandria, Egypt.'}, {'ForeName': 'C I', 'Initials': 'CI', 'LastName': 'Farid', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Alexandria University, 106 Port Said street, Camp Cesar, Alexandria, Egypt. Electronic address: KARMIN.FRED@alexmed.edu.eg.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Mehanna', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Alexandria University, Egypt; Center of Excellence for Research in Regenerative Medicine and Applications (CERRMA), Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'N H', 'Initials': 'NH', 'LastName': 'Bayoumi', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Ismail', 'Affiliation': 'Department of Dermatology, Venereology, and Andrology, Faculty of Medicine, Alexandria University, 106 Port Said street, Camp Cesar, Alexandria, Egypt.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2021.12.005']
413,35131497,Monofilament vs multifilament suture for uterine closure at the time of cesarean delivery: a randomized clinical trial.,"BACKGROUND


Different factors may influence the closure of the uterine wall, including suture material. Suture materials may indeed influence tissue healing and therefore the development of scar defects.
OBJECTIVE


To test whether uterine closure using synthetic absorbable monofilament sutures at the time of cesarean delivery would reduce the rate of cesarean scar defects compared with uterine closure using synthetic absorbable multifilament sutures.
STUDY DESIGN


Parallel-group, nonblinded, randomized clinical trial of women with singleton pregnancies undergoing cesarean delivery at term in a single center in Italy. The inclusion criteria were singleton pregnancy, first or second cesarean delivery, scheduled and emergent or urgent cesarean deliveries, and gestational age between 37 0/7 and 42 0/7 weeks. Eligible participants were randomly allocated in a 1:1 ratio to either the monofilament group (polyglytone 6211 [Caprosyn]; Covidien, Dublin, Ireland) or the multifilament suture group (coated polyglactin 910 suture with Triclosan [Vicryl Plus]; Ethicon, Inc, Raritan, NJ). The primary outcome was the incidence of cesarean scar defect at ultrasound at the 6-month follow-up visit. The secondary outcomes were residual myometrial thickness and symptoms.
RESULTS


Overall, 300 women were included in the trial. Of the randomized women, 151 were randomized to the monofilament group and 149 to the multifilament group. However, 27 women were lost to follow-up: 15 in the monofilament group and 12 in the multifilament group. Of note, 6 months after delivery, the incidence rates of cesarean scar defect were 18.4% (25 of 136 patients) in the monofilament group and 23.4% (32 of 137 patients) in the multifilament group (relative risk, 0.79; 95% confidence interval, 0.41-1.25; P=.31). The mean residual myometrial thicknesses were 7.6 mm in the monofilament group and 7.2 mm in the multifilament group (mean difference, +0.40 mm; 95% confidence interval, -0.23 to 1.03). There was no between-group substantial difference found in the incidence of symptoms, including pelvic pain, painful periods, and dyspareunia.
CONCLUSION


In singleton pregnancies undergoing primary or second cesarean delivery, the use of synthetic absorbable monofilament sutures at the time of uterine wall closure was not associated with a reduction in the rate of cesarean scar defect 6 months after delivery compared with the use of synthetic absorbable multifilament sutures.",2022,"No between group significant differences were found in the incidence of symptoms, including pelvic pain, painful periods, and dyspareunia.
","['27 women were lost to follow up, 15 in the monofilament group, and 12 in the multifilament group', 'Inclusion criteria were singleton pregnancy, first or second cesarean delivery, scheduled and emergent or urgent cesarean delivery, gestational age between 37 0/7 and 42 0/7 weeks', '300 women were included in the trial', 'Eligible participants', 'singleton gestations undergoing primary or second cesarean delivery, use of', 'women with singleton pregnancies undergoing cesarean delivery at term in a single center in Italy']","['Monofilament vs multifilament suture', 'synthetic absorbable multifilament sutures', 'monofilament (Polyglytone 6211; Caprosyn, Covidien) or to the multifilament suture group (coated Polyglactin 910 suture with Triclosan; Vicryl Plus, Ethicon', 'synthetic absorbable monofilament sutures']","['residual myometrial thickness (RMT), and symptoms', 'incidence of symptoms, including pelvic pain, painful periods, and dyspareunia', 'rate of cesarean scar defect', 'incidence of cesarean scar defect', 'rate of cesarean scar defects', 'mean RMT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1961533', 'cui_str': 'Multifilament suture'}, {'cui': 'C1702173', 'cui_str': 'polyglytone 6211'}, {'cui': 'C1698175', 'cui_str': 'Caprosyn'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0032495', 'cui_str': 'Polygalactin 910'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1961537', 'cui_str': 'Monofilament suture'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1275590', 'cui_str': 'Thickness of myometrium'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",300.0,0.197888,"No between group significant differences were found in the incidence of symptoms, including pelvic pain, painful periods, and dyspareunia.
","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco). Electronic address: gabriele.saccone.1990@gmail.com.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'De Angelis', 'Affiliation': 'Department of Public Health, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Angelis and Di Spiezio Sardo).'}, {'ForeName': 'Brunella', 'Initials': 'B', 'LastName': 'Zizolfi', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Gragnano', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Musone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Zullo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bifulco', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Di Spiezio Sardo', 'Affiliation': 'Department of Public Health, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Angelis and Di Spiezio Sardo).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100592']
414,35121216,Prophylactic Ranibizumab to Prevent Neovascular Age-Related Macular Degeneration in Vulnerable Fellow Eyes: A Randomized Clinical Trial.,"PURPOSE


To determine whether prophylactic ranibizumab prevents the development of neovascular age-related macular degeneration (nAMD) in eyes with intermediate age-related macular degeneration (AMD) for patients with preexisting nAMD in their contralateral eye.
DESIGN


Multicenter randomized clinical trial.
PARTICIPANTS


Adults aged 50 years and older with intermediate AMD (multiple intermediate drusen [≥63 μm and <125 μm] or ≥1 large drusen [≥125 μm] and pigmentary changes) in the study eye and nAMD in the contralateral eye.
INTERVENTION


Intravitreal ranibizumab injection (0.5 mg) or sham injection every 3 months for 24 months.
MAIN OUTCOME MEASURES


Conversion to nAMD over 24 months (primary). Change in best-corrected visual acuity from baseline to 24 months (secondary).
RESULTS


Among 108 enrolled participants (54 [50%] in each group), all except 2 were non-Hispanic Whites, 61 participants (56%) were female, and the mean age was 78 years. The mean baseline visual acuity was 77.7 letters (Snellen equivalent 20/32). Conversion to nAMD over 24 months occurred among 7 of 54 eyes (13%) in both groups (ranibizumab vs. sham hazard ratio = 0.91 [95% confidence interval (CI), 0.32-2.59]; P = 0.86). At 24 months, the cumulative incidence of nAMD adjusted for loss to follow-up was 14% (95% CI, 4%-23%) in the ranibizumab group and 15% (95% CI, 4%-25%) in the sham group. At 24 months, the mean change in visual acuity from baseline was -2.1 letters (standard deviation, 5.4 letters) with ranibizumab and -1.4 letters (standard deviation, 7.7 letters) with sham (adjusted difference = -0.8 letters [95% CI, -3.7 to 2.2 letters]; P = 0.62). The proportion of eyes that lost at least 10 letters of visual acuity from baseline at 24 months was 2 of 39 (5%) with ranibizumab and 4 of 40 (10%) with sham. There were no serious ocular adverse events in either group.
CONCLUSIONS


Quarterly dosing of 0.5 mg ranibizumab in eyes with intermediate AMD did not reduce the incidence of nAMD compared with sham injections; however, the study was likely underpowered given the 95% CI, and a clinically meaningful effect cannot be excluded. There also was no effect on visual acuity at 24 months. Other strategies to reduce neovascular conversion in these vulnerable eyes are needed.",2022,"There were no serious ocular adverse events in either group.
","['Vulnerable Fellow Eyes', 'Adults aged 50 and older with intermediate AMD (multiple intermediate drusen [≥ 63 μm and <125 μm] or ≥1 large drusen [≥125 μm] and pigmentary changes) in the study eye and nAMD in the contralateral eye', 'neovascular age-related macular degeneration (nAMD) in eyes with intermediate AMD for patients with pre-existing nAMD in their contralateral eye', '108 enrolled participants (54 [50%] in each group), all except two were non-Hispanic Whites, 61 participants (56%) were female, and the mean age was 78 years']","['Intravitreal ranibizumab injection', 'prophylactic ranibizumab', 'Prophylactic Ranibizumab', 'ranibizumab']","['serious ocular adverse events', 'rate of conversion to nAMD', 'mean change in visual acuity', 'incidence of nAMD', 'mean baseline visual acuity', 'cumulative incidence of nAMD', 'visual acuity']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1260926', 'cui_str': 'Abnormal pigmentation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",108.0,0.802666,"There were no serious ocular adverse events in either group.
","[{'ForeName': 'Clement K', 'Initials': 'CK', 'LastName': 'Chan', 'Affiliation': 'Southern California Desert Retina Consultants, Palm Desert, California; Department of Ophthalmology, Loma Linda University, Loma Linda, California. Electronic address: cchan@desertretina.com.'}, {'ForeName': 'Maziar', 'Initials': 'M', 'LastName': 'Lalezary', 'Affiliation': 'Doctor Retina, Beverly Hills, California.'}, {'ForeName': 'Prema', 'Initials': 'P', 'LastName': 'Abraham', 'Affiliation': 'Black Hills Regional Eye Institute, Rapid City, South Dakota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Elman', 'Affiliation': 'Elman Retina Group, Baltimore, Maryland.'}, {'ForeName': 'Wesley Thomas', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Lin', 'Affiliation': 'Southern California Desert Retina Consultants, Palm Desert, California.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, San Jose, California.'}, {'ForeName': 'Alok S', 'Initials': 'AS', 'LastName': 'Bansal', 'Affiliation': 'Northern California Retina Vitreous Associates, San Jose, California.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Wieland', 'Affiliation': 'Northern California Retina Vitreous Associates, San Jose, California.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Palmer', 'Affiliation': 'Northern California Retina Vitreous Associates, San Jose, California.'}, {'ForeName': 'Louis K', 'Initials': 'LK', 'LastName': 'Chang', 'Affiliation': 'Northern California Retina Vitreous Associates, San Jose, California.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Lujan', 'Affiliation': 'Oregon Health and Science University Casey Eye Institute, Portland, Oregon.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Yiu', 'Affiliation': 'University of California Davis Reading Center, UC Davis Health, Sacramento, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2022.01.019']
415,35124345,Steps to recovery: Body weight-supported treadmill training for critically ill patients: A randomized controlled trial.,"PURPOSE


Early mobilization of critically ill patients improves functional recovery, but is often hampered by tubes, drains, monitoring devices and muscular weakness. A mobile treadmill with bodyweight support facilitates early mobilization and may shorten recovery time to independent ambulation as compared to usual care physiotherapy alone.
MATERIALS AND METHODS


Single center RCT, comparing daily bodyweight supported treadmill training (BWSTT) with usual care physiotherapy, in patients who had been or were mechanically ventilated (≥48 h) with ≥MRC grade 2 quadriceps muscle strength. BWSTT consisted of daily treadmill training in addition to usual care physiotherapy (PT). Primary outcome was time to independent ambulation measured in days, using the Functional Ambulation Categories (FAC-score: 3). Secondary outcomes included hospital length of stay and serious adverse events.
RESULTS


The median (IQR) time to independent ambulation was 6 (3 to 9) days in the BWSTT group (n = 19) compared to 11 (7 to 23) days in the usual care group (n = 21, p = 0.063). Hospital length of stay was significantly different in favour of the BWSTT group (p = 0.037). No serious adverse events occurred.
INTERPRETATION


BWSTT seems a promising intervention to enhance recovery of ambulation and shorten hospital length of stay of ICU patients, justifying a sufficiently powered multicenter RCT.
TRIAL REGISTRATION NUMBER


Dutch Trial Register ID: NTR6943.",2022,Hospital length of stay was significantly different in favour of the BWSTT group (p = 0.037).,"['critically ill patients', 'patients who had been or were mechanically ventilated (≥48 h) with ≥MRC grade 2 quadriceps muscle strength']","['daily bodyweight supported treadmill training (BWSTT) with usual care physiotherapy', 'recovery: Body weight-supported treadmill training', 'daily treadmill training']","['functional recovery', 'time to independent ambulation measured in days, using the Functional Ambulation Categories (FAC-score: 3', 'hospital length of stay and serious adverse events', 'median (IQR) time to independent ambulation', 'Hospital length of stay']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0695503,Hospital length of stay was significantly different in favour of the BWSTT group (p = 0.037).,"[{'ForeName': 'Robin C H', 'Initials': 'RCH', 'LastName': 'Kwakman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands; Faculty of Health, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands; Education of Physiotherapy, University of Applied Sciences Amsterdam, Amsterdam, the Netherlands. Electronic address: r.c.h.kwakman@hva.nl.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Voorn', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands. Electronic address: e.l.voorn@amsterdamumc.nl.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Intensive Care, Amsterdam Neurosciences, Meibergdreef 9, Amsterdam, Netherlands. Electronic address: j.horn@amsterdamumc.nl.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands. Electronic address: f.nollet@amsterdamumc.nl.'}, {'ForeName': 'Raoul H H', 'Initials': 'RHH', 'LastName': 'Engelbert', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands; Faculty of Health, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands. Electronic address: r.h.h.engelbert@amsterdamumc.nl.'}, {'ForeName': 'Juultje', 'Initials': 'J', 'LastName': 'Sommers', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands. Electronic address: j.sommers@amsterdamumc.nl.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'van der Schaaf', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands; Faculty of Health, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands. Electronic address: m.vanderschaaf@amsterdamumc.nl.'}]",Journal of critical care,['10.1016/j.jcrc.2022.154000']
416,35129242,"HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.","BACKGROUND AND AIM


Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results.
DESIGN


Open-label, non-inferiority randomized trial.
SETTING


Six US HIV primary care clinics.
PARTICIPANTS


A total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment.
INTERVENTION


HIV clinic-based extended-release naltrexone (XR-NTX; n = 55) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; n = 59).
MEASUREMENTS


Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA ≤ 200 copies/ml) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks.
FINDINGS


Fewer XR-NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) [risk ratio (RR) = 1.064; 95% confidence interval (CI) = 0.748, 1.514] at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre-specified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX versus TAU (11.7 versus 14.8 days; mean difference = -3.1; 95% CI = -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 versus 13.6, mean difference = -7.6; 95% CI = -13.8, -0.2).
CONCLUSIONS


A randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended-release naltrexone used fewer opioids than those who received treatment as usual.",2022,"Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 vs. 13.6, mean difference -7.6; 95% CI -13.8, -0.2).
","['Six U.S. HIV primary care clinics', 'People with HIV and Opioid Use Disorder', '114 participants with untreated HIV and OUD (62% male; 56% Black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%), and cocaine (60%) at baseline']","['HIV Clinic-Based Extended Release Naltrexone', 'buprenorphine or methadone (TAU; n=59', 'HIV clinic-based extended-release naltrexone (XR-NTX', 'naltrexone']","['viral suppression', 'XR-NTX', 'past 30-day opioid use']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3539175', 'cui_str': 'Other opioids'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",114.0,0.691939,"Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 vs. 13.6, mean difference -7.6; 95% CI -13.8, -0.2).
","[{'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Ryan R', 'Initials': 'RR', 'LastName': 'Cook', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Lum', 'Affiliation': 'Division of HIV, ID and Global Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Elizabeth Needham', 'Initials': 'EN', 'LastName': 'Waddell', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Hansel', 'Initials': 'H', 'LastName': 'Tookes', 'Affiliation': 'Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Vergara-Rodriguez', 'Affiliation': 'Ruth M. Rothstein CORE Center, Department of Psychiatry and Department of Internal Medicine, Cook County Health, Chicago, IL, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Kunkel', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Lucas', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Allan E', 'Initials': 'AE', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Sarann', 'Initials': 'S', 'LastName': 'Bielavitz', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Fanucchi', 'Affiliation': 'Division of Infectious Diseases and Center on Drug and Alcohol Research, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Hoffman', 'Affiliation': 'Oregon Health and Science University-Portland State University School of Public Health, Portland, OR, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Bachrach', 'Affiliation': 'Tarzana Treatment Centers, Tarzana, CA, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Payne', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Collins', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Matthews', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Oden', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Jacobs', 'Affiliation': 'National Institutes of Health, National Institute on Aging, Bethesda, MD, USA.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Jelstrom', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Sorensen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'McCarty', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15836']
417,35134988,Longitudinal Electronic Cigarette Use Among Patients Recently Diagnosed With Cancer Enrolled in a Smoking Cessation Trial.,"INTRODUCTION


Many cancer patients who smoke report concurrent e-cigarette use. Using a mixed-methods approach, we aimed to (1) describe longitudinal e-cigarette use over 6 months after a cancer diagnosis and (2) assess the association between e-cigarette use and smoking cessation, among cancer patients in a smoking cessation trial.
AIMS AND METHODS


Data were from a 2-site randomized controlled trial of Standard (brief counseling) versus Intensive treatment (sustained counseling plus smoking cessation medication) in individuals who smoke recently diagnosed with cancer. Participants (n = 303) reported e-cigarette use at baseline, 3 months, and 6 months. Biochemically-verified past 7-day cigarette abstinence was collected at 6 months. Qualitative interviews at 6 months explored factors related to e-cigarette use.
RESULTS


E-cigarette use prevalence was highest between baseline and 3 months (16%) and declined over time. Participants using e-cigarettes at follow-up had higher baseline cigarette dependence and smoked more heavily. Multivariable analyses found no significant association between follow-up e-cigarette use and 6-month cigarette abstinence. E-cigarette use at follow-up was higher in the Standard versus Intensive treatment group (p = .003 and .001 at 3 and 6 mo, respectively). Smoking cessation and health concerns were primary reasons for using e-cigarettes.
CONCLUSIONS


Among individuals who smoke recently diagnosed with cancer and enrolled in a smoking cessation intervention trial, e-cigarette use during trial participation was not associated with smoking abstinence. Individuals who chose to use e-cigarettes were less likely to be receiving intensive cessation support as part of the trial. Further studies are needed to evaluate the association between e-cigarette use and smoking cessation in cancer patients.
IMPLICATIONS


E-cigarette use was not associated with cigarette abstinence at 6 months among adults who smoke recently diagnosed with cancer enrolled in a smoking cessation trial. Individuals with easier access to evidence-based smoking cessation treatment may be less likely to use e-cigarettes.",2022,"E-cigarette use at follow-up was higher in the Standard vs Intensive treatment group (p=0.003 and 0.001 at 3 and 6 mo, respectively).","['cancer patients who smoke report concurrent e-cigarette use', 'individuals who smoke recently diagnosed with cancer and enrolled in a smoking cessation intervention trial, e-cigarette use during trial participation was not associated with smoking abstinence', 'Patients', 'cancer patients in a smoking cessation trial', 'adults who smoke recently diagnosed with cancer enrolled in a smoking cessation trial', 'cancer patients', 'individuals who smoke recently diagnosed with cancer', 'Participants using e-cigarettes at follow-up had higher baseline cigarette dependence and smoked more heavily', 'Recently Diagnosed with Cancer Enrolled in a Smoking Cessation Trial']",['Standard (brief counseling) vs Intensive treatment (sustained counseling plus smoking cessation medication'],['E-cigarette use prevalence'],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C4083280', 'cui_str': 'Vape'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C4083280', 'cui_str': 'Vape'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.0906373,"E-cigarette use at follow-up was higher in the Standard vs Intensive treatment group (p=0.003 and 0.001 at 3 and 6 mo, respectively).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kalkhoran', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Gina R', 'Initials': 'GR', 'LastName': 'Kruse', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Ponzani', 'Affiliation': 'The Mongan Institute, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'MGH Center for Biostatistics, Boston, MA, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ostroff', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntac031']
418,35135684,Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial.,"BACKGROUND


Early amniotomy shortens the duration of spontaneous labor, yet there is no clear evidence on the optimal timing of amniotomy following cervical ripening. There are limited high-quality studies on the use of early amniotomy intervention following labor induction.
OBJECTIVE


This study aimed to evaluate whether amniotomy within 1 hour of Foley catheter expulsion reduces the duration of labor among individuals undergoing combined misoprostol and Foley catheter labor induction at term.
STUDY DESIGN


This was a randomized clinical trial conducted from November 2020 to May 2021 comparing amniotomy within 1 hour of Foley catheter expulsion (early artificial rupture of membranes) with expectant management. Randomization was stratified by parity. Labor management was standardized among participants. Individuals undergoing induction at ≥37 weeks with a singleton gestation and needing cervical ripening were eligible. Our primary outcome was time to delivery. Wilcoxon rank sum, Pearson chi-square, and Cox survival analyses with intent-to-treat principles were performed adjusting for age, body mass index, parity, mode of delivery, Bishop score, and the interaction between randomization group and parity. A sample size of 160 was planned to detect a 4-hour reduction in delivery time.
RESULTS


A total of 160 patients (79 early artificial rupture of membranes, 81 expectant management) were randomized. Early artificial rupture of membranes achieved a faster median time to delivery than expectant management (early artificial rupture of membranes: 11.1 hours; interquartile range, 6.25-17.1 vs expectant management: 19.8 hours; interquartile range, 13.2-26.2; P<.001). A greater percentage of individuals in the early artificial rupture of membranes group delivered within 24 hours (86% vs 70%; P=.03). There was no difference in the cesarean delivery rate between the 2 groups (22% vs 31%; P=.25). Individuals delivered 2.3 times faster following early artificial rupture of membranes (hazard ratio, 2.3; 95% confidence interval, 1.5-3.4; P<.001). There were no significant differences in maternal and neonatal outcomes.
CONCLUSION


Amniotomy within 1 hour of Foley catheter expulsion resulted in 2.3 times faster delivery than expectant management. Therefore, early artificial rupture of membranes should be considered in individuals undergoing mechanical cervical ripening at term.",2022,There was no difference in the cesarean delivery rate between the 2 groups (22% vs 31%; P=.25).,"['from November 2020 to May 2021 comparing amniotomy within 1 hour of Foley catheter expulsion (early artificial rupture of membranes) with expectant management', 'individuals undergoing combined misoprostol and Foley catheter labor induction at term', '160 patients (79 early artificial rupture of membranes, 81 expectant management', 'individuals undergoing mechanical cervical ripening at term', 'Individuals undergoing induction at ≥37 weeks with a singleton gestation and needing cervical ripening were eligible']","['Foley catheter expulsion', 'Foley catheter ripening']","['time to delivery', 'Wilcoxon rank sum, Pearson chi-square, and Cox survival analyses', 'Labor management', 'duration of labor', 'cesarean delivery rate', 'maternal and neonatal outcomes']","[{'cui': 'C1384591', 'cui_str': 'Artificial rupture of membranes'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0177273', 'cui_str': 'Amniotomy at delivery'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0600454', 'cui_str': 'Cervical Ripening'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",160.0,0.190457,There was no difference in the cesarean delivery rate between the 2 groups (22% vs 31%; P=.25).,"[{'ForeName': 'Helen B', 'Initials': 'HB', 'LastName': 'Gomez Slagle', 'Affiliation': 'Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE. Electronic address: Helen.gomez@christianacare.org.'}, {'ForeName': 'Yaneve N', 'Initials': 'YN', 'LastName': 'Fonge', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Pittsburgh Medical Center, Pittsburg, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Caplan', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Pittsburgh Medical Center, Pittsburg, PA; Institute for Research on Equity and Community Health, Christiana Care Health System, Newark, DE, (d)Delaware Center for Maternal-Fetal Medicine, Newark, DE.'}, {'ForeName': 'Courtney K', 'Initials': 'CK', 'LastName': 'Pfeuti', 'Affiliation': 'Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Sciscione', 'Affiliation': 'Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE; Delaware Center for Maternal-Fetal Medicine, Newark, DE.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Hoffman', 'Affiliation': 'Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2021.11.1368']
419,35122746,Effect of Mindfulness-Based Stress Reduction on Intraocular Pressure in Patients With Ocular Hypertension: A Randomized Control Trial.,"PURPOSE


To evaluate the effect of mindfulness-based stress reduction (MBSR) on intraocular pressure (IOP) in patients with ocular hypertension (OHT).
DESIGN


Parallel arm, single masked, randomized controlled trial.
METHODS


Sixty patients with ocular hypertension and IOP > 21 and < 30 mmHg were recruited at a tertiary eye care centre in India. Thirty patients (group 1) underwent six weeks of one hour daily MBSR sessions, while the other 30 patients (group 2) were waitlisted and kept on follow-up. The primary outcome was change in IOP (ΔIOP) after six weeks of MBSR. Secondary outcomes were effect on serum cortisol level, diurnal variation of IOP, vessel perfusion and vessel density on optical coherence tomography angiography (OCTA), and quality of life (QOL).
RESULTS


At six weeks, a significant decrease in IOP was noted in group 1 (23.05 ± 1.17 to 19.15 ± 1.45 mmHg; P = .001) compared with group 2 (22.55 ± 0.98 mmHg to 22.37 ± 1.07 mmHg; P = .107). The ΔIOP was significantly greater in group 1 (3.93 ± 1.47) than group 2 (0.17 ± 0.58; P = .001). The diurnal fluctuation of IOP decreased in group 1 (4.87 ± 1.13 mmHg to 2.73 ± 0.98 mmHg; P = .001) as compared with group 2 (4.50 ± 0.86 mmHg to 4.30 ± 0.83 mmHg; P = .227). Significant improvement in vessel perfusion, vessel density, and flux index was noted on OCTA in group 1 compared with group 2. Group 1 showed a significant decrease (P ≤ .001) in serum cortisol level and an improved QOL (P = .001).
CONCLUSION


Mindfulness-based stress reduction was associated with a significant decrease in IOP and serum cortisol, along with an improvement in optic nerve head perfusion and QOL. Mindfulness-based stress reduction can be considered as a potential treatment option in the management of OHT.",2022,"Significant improvement in vessel perfusion, vessel density and flux index was noted on OCTA in group 1 as compared to group 2.","['patients with ocular hypertension', 'patients with ocular hypertension (OHT', 'Sixty patients of ocular hypertension, with IOP >21 and <30 mmHg were recruited at a tertiary eye care centre in India']","['mindfulness-based stress reduction (MBSR', 'MBSR', 'mindfulness-based stress reduction on IOP']","['intraocular pressure (IOP', 'vessel perfusion, vessel density and flux index', 'serum cortisol level and an improved QOL', 'IOP and serum cortisol', 'MBSR', 'IOP', 'ΔIOP', 'diurnal fluctuation of IOP', 'change in IOP (ΔIOP', 'serum cortisol level, diurnal variation of IOP, vessel perfusion and vessel density on optical coherence tomography angiography (OCTA) and quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",60.0,0.0450017,"Significant improvement in vessel perfusion, vessel density and flux index was noted on OCTA in group 1 as compared to group 2.","[{'ForeName': 'Tanuj', 'Initials': 'T', 'LastName': 'Dada', 'Affiliation': 'From Dr. Rajendra Prasad Centre for Ophthalmic Sciences (T.D, S.M, N.M, K.M, R.S, S.G, D.A); Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India (R.K.Y). Electronic address: tanujdada@gmail.com.'}, {'ForeName': 'Sudip', 'Initials': 'S', 'LastName': 'Mondal', 'Affiliation': 'From Dr. Rajendra Prasad Centre for Ophthalmic Sciences (T.D, S.M, N.M, K.M, R.S, S.G, D.A); Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India (R.K.Y).'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Midha', 'Affiliation': 'From Dr. Rajendra Prasad Centre for Ophthalmic Sciences (T.D, S.M, N.M, K.M, R.S, S.G, D.A); Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India (R.K.Y).'}, {'ForeName': 'Karthikeyan', 'Initials': 'K', 'LastName': 'Mahalingam', 'Affiliation': 'From Dr. Rajendra Prasad Centre for Ophthalmic Sciences (T.D, S.M, N.M, K.M, R.S, S.G, D.A); Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India (R.K.Y).'}, {'ForeName': 'Ramanjit', 'Initials': 'R', 'LastName': 'Sihota', 'Affiliation': 'From Dr. Rajendra Prasad Centre for Ophthalmic Sciences (T.D, S.M, N.M, K.M, R.S, S.G, D.A); Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India (R.K.Y).'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'From Dr. Rajendra Prasad Centre for Ophthalmic Sciences (T.D, S.M, N.M, K.M, R.S, S.G, D.A); Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India (R.K.Y).'}, {'ForeName': 'Dewang', 'Initials': 'D', 'LastName': 'Angmo', 'Affiliation': 'From Dr. Rajendra Prasad Centre for Ophthalmic Sciences (T.D, S.M, N.M, K.M, R.S, S.G, D.A); Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India (R.K.Y).'}, {'ForeName': 'Raj Kumar', 'Initials': 'RK', 'LastName': 'Yadav', 'Affiliation': 'From Dr. Rajendra Prasad Centre for Ophthalmic Sciences (T.D, S.M, N.M, K.M, R.S, S.G, D.A); Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India (R.K.Y).'}]",American journal of ophthalmology,['10.1016/j.ajo.2022.01.017']
420,35130547,"Flaxseed Mucilage (IQP-LU-104) Reduces Body Weight in Overweight and Moderately Obese Individuals in a 12-week, Three-Arm, Double-Blind, Randomized, and Placebo-Controlled Clinical Study.","INTRODUCTION


The aim of this study was to evaluate the benefit and tolerability of two dosages of a proprietary flaxseed mucilage (IQP-LU-104) in reducing body weight in overweight and moderately obese individuals.
METHODS


In a double-blind, randomized, placebo-controlled, bi-center trial, 108 participants (body mass index [BMI] 25-<35 kg/m2) were randomly allocated to receive either IQP-LU-104 high dose (104HD), IQP-LU-104 low dose (104LD), or placebo. Participants were instructed to consume 1 sachet of the investigational product (containing IQP-LU-104 or matching placebo) before or with main meals twice daily and to follow a balanced but hypocaloric diet (20% reduction of individual's daily energy requirements) for 12 weeks. At week 0 (baseline), and weeks 4, 8, and 12 of the intervention periods, the participants' body weight, BMI, body fat composition, and waist and hip circumferences were measured. Blood samples were collected for safety assessment at screening visit (week -2) and at the end of the study. Adverse events were assessed by the investigators through interviewing the participants and were recorded at every visit post screening.
RESULTS


At the end of the 12-week study, body weight reduction was greater in the 104HD group (4.96 ± 1.89 kg, p < 0.001 vs. placebo) and 104LD group (3.70 ± 2.57 kg, p < 0.001 vs. placebo) compared to the placebo group (1.33 ± 2.05 kg). 68% and 46% of participants in the 104HD group (p < 0.001 vs. placebo) and 104LD group (p = 0.002 vs. placebo), respectively, experienced at least 5% weight loss, compared to 9% of participants in the placebo group. Significant decreases in waist and hip circumferences were observed in both the 104HD and 104LD groups compared to the placebo group (each p < 0.001). 104HD group had significantly higher reduction in body fat mass (4.25 ± 5.86 kg) than the placebo group (1.06 ± 3.20 kg) (p = 0.002). Respiratory tract infections and gastrointestinal symptoms were the main adverse events reported and none of the adverse events were related to the intake of IQP-LU-104.
CONCLUSION


Results demonstrated IQP-LU-104 is safe and efficacious in body weight reduction at both dosages in overweight and moderately obese individuals.",2022,Significant decreases in waist and hip circumferences were observed in both the 104HD and 104LD groups compared to the placebo group (each p < 0.001).,"['overweight and moderately obese individuals', 'Obese Individuals', '108 participants (Body Mass Index (BMI) 25 to < 35 kg/m2']","['placebo', 'proprietary flaxseed mucilage (IQP-LU-104', 'Placebo', 'IQP-LU-104 high dose (104HD), IQP-LU-104 low dose (104LD), or placebo', 'consume 1 sachet of the investigational product (containing IQP-LU-104 or matching placebo) before or with main meals twice daily and to follow a balanced but hypocaloric diet', 'Flaxseed Mucilage (IQP-LU-104']","['weight loss', 'Respiratory tract infections and gastrointestinal symptoms', 'Body Weight', 'Adverse events', 'benefit and tolerability', 'body weight', 'waist and hip circumferences', 'body fat mass', 'body weight reduction']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",108.0,0.482234,Significant decreases in waist and hip circumferences were observed in both the 104HD and 104LD groups compared to the placebo group (each p < 0.001).,"[{'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Bongartz', 'Affiliation': 'Analyze & Realize GmbH, Berlin, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Hochmann', 'Affiliation': 'Analyze & Realize GmbH, Berlin, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Grube', 'Affiliation': 'Practice for General Medicine, Berlin, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Uebelhack', 'Affiliation': 'Analyze & Realize GmbH, Berlin, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Alt', 'Affiliation': 'Analyze & Realize GmbH, Berlin, Germany.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Erlenbeck', 'Affiliation': 'Analyze & Realize GmbH, Berlin, Germany.'}, {'ForeName': 'Li Vern', 'Initials': 'LV', 'LastName': 'Peng', 'Affiliation': 'InQpharm Group Sdn Bhd, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Pee Win', 'Initials': 'PW', 'LastName': 'Chong', 'Affiliation': 'InQpharm Group Sdn Bhd, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'De Costa', 'Affiliation': 'InQpharm Group Sdn Bhd, Kuala Lumpur, Malaysia.'}]",Obesity facts,['10.1159/000522082']
421,35134817,A Differential Response to Antihypertensive Therapy in African Men and Women: Insights From the CREOLE Trial.,"BACKGROUND


We sought to address the paucity of data to support the evidence-based management of hypertension to achieve optimal blood pressure (BP) control on a sex-specific basis in Africa.
METHODS


We undertook a post hoc analysis of the multicenter, randomized CREOLE (Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans) Trial to test the hypothesis that there would be clinically important differences in office BP control between African men and women. We compared the BP levels of 397 and 238 hypertensive women (63%, 50.9 ± 10.5 years) and men (51.2 ± 11.3 years) from 10 sites across sub-Saharan Africa who completed baseline and 6-month profiling according to their randomly allocated antihypertensive treatment.
RESULTS


Overall, 442/635 (69.6%) participants achieved an office BP target of <140/90 mm Hg at 6 months; comprising more women (286/72.0%) than men (156/65.5%) (adjusted odds ratio [OR] 1.59, 95% confidence interval [CI] 1.07-2.39; P = 0.023). Women randomized to amlodipine-hydrochlorothiazide (HCTZ) (adjusted OR 3.03, 95% CI 1.71-5.35; P < 0.001) or amlodipine-perindopril (adjusted OR 2.62, 95% CI 1.49-4.58; P = 0.01) were more likely to achieve this target compared with perindopril-HCTZ. Among men, there were no equivalent treatment differences-amlodipine-HCTZ (OR 1.54, 95% CI 0.76-3.12; P = 0.23) or amlodipine-perindopril (OR 1.32, 95% CI 0.65-2.67; P = 0.44) vs. perindopril-HCTZ. Among the 613 participants (97%) with 24-hour ambulatory BP monitoring, women had significantly lower systolic (124.1 ± 18.1 vs. 127.3 ± 16.9; P = 0.028) and diastolic (72.7 ± 10.4 vs. 75.1 ± 10.5; P = 0.007) BP levels at 6 months compared with men.
CONCLUSIONS


These data suggest clinically important differences in the therapeutic response to antihypertensive combination therapy among African women compared with African men.",2022,"Women randomized to amlodipine-hydrochlorothiazide (adjusted OR 3.03, 95% CI 1.71-5.35; p<0.001) or amlodipine-perindopril (adjusted OR 2.62, 95% CI 1.49-4.58; p=0.01) were more likely to achieve this target compared to perindopril-hydrochlorothiazide.","['397 and 238 hypertensive women (63%, 50.9±10.5 years) and men (51.2±11.3 years) from 10 sites across Sub-Saharan Africa who completed baseline and 6-month profiling according to their randomly allocated anti-hypertensive treatment', 'Black Africans', 'African women compared to African men', 'African Men and Women', 'African men and women']","['Anti-Hypertensive Therapy', 'amlodipine-perindopril', 'perindopril-hydrochlorothiazide', 'amlodipine-hydrochlorothiazide']","['lower systolic', 'office BP target', 'BP levels']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0027567', 'cui_str': 'African race'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2931929', 'cui_str': 'perindopril and amlodipine'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",613.0,0.225595,"Women randomized to amlodipine-hydrochlorothiazide (adjusted OR 3.03, 95% CI 1.71-5.35; p<0.001) or amlodipine-perindopril (adjusted OR 2.62, 95% CI 1.49-4.58; p=0.01) were more likely to achieve this target compared to perindopril-hydrochlorothiazide.","[{'ForeName': 'Dike B', 'Initials': 'DB', 'LastName': 'Ojji', 'Affiliation': 'Department of Medicine, Faculty of Clinical Sciences, University of Abuja & University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Gabriel L', 'Initials': 'GL', 'LastName': 'Shedul', 'Affiliation': 'Cardiovascular Research Unit, Department of Internal Medicine, University of Abuja, Abuja, Nigeria.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Sani', 'Affiliation': 'Department of Medicine, Bayero University, Kano & Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Okechukwu S', 'Initials': 'OS', 'LastName': 'Ogah', 'Affiliation': 'Department of Medicine, Faculty of Clinical Sciences, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Anastase', 'Initials': 'A', 'LastName': 'Dzudie', 'Affiliation': 'Department of Medicine, Douala General Hospital, Douala, Cameroon.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Barasa', 'Affiliation': 'Department of Medicine, MOI University Hospital, Eldoret, Kenya.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Mondo', 'Affiliation': 'Department of Medicine, St Francis Hospital, Nsambya, Kampala, Uganda.'}, {'ForeName': 'Prossie M', 'Initials': 'PM', 'LastName': 'Ingabire', 'Affiliation': 'Department of Medicine, St Francis Hospital, Nsambya, Kampala, Uganda.'}, {'ForeName': 'Erika S W', 'Initials': 'ESW', 'LastName': 'Jones', 'Affiliation': 'Division of Nephrology and Hypertension, Groote Schuur Hospital and University of Cape Town, South Africa.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Rayner', 'Affiliation': 'Division of Nephrology and Hypertension, Groote Schuur Hospital and University of Cape Town, South Africa.'}, {'ForeName': 'Damasceno', 'Initials': 'D', 'LastName': 'Albertino', 'Affiliation': 'Department of Medicine, Eduardo Mondlane University Hospital, Maputo, Mozambique.'}, {'ForeName': 'Elijah', 'Initials': 'E', 'LastName': 'Ogola', 'Affiliation': 'Department of Clinical Medicine and Therapeutics, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Wynand', 'Initials': 'W', 'LastName': 'Smythe', 'Affiliation': 'Department of Pharmacy, Life St. Vincent Pallotti Hospital in Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Hickman', 'Affiliation': 'Clinical Research Centre, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Francis', 'Affiliation': 'Department of Pharmacy, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Pandie', 'Initials': 'P', 'LastName': 'Shahiemah', 'Affiliation': 'Department of Pharmacy, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Shedul', 'Affiliation': 'Cardiovascular Research Unit, Department of Internal Medicine, University of Abuja, Abuja, Nigeria.'}, {'ForeName': 'Akinyemi', 'Initials': 'A', 'LastName': 'Aje', 'Affiliation': 'Department of Medicine, University College Hospital, Ibadan, Nigeria.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'Cape Heart Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Stewart', 'Affiliation': 'Cape Heart Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}]",American journal of hypertension,['10.1093/ajh/hpac014']
422,35134800,Comparative Bioavailability Study of Solid Self-Nanoemulsifying Drug Delivery System of Fenofibric Acid in Healthy Male Subjects.,"OBJECTIVE


This study aimed to evaluate the effect of solid self-nanoemulsifying drug delivery system (S-SNEDDS) formation on the bioavailability of fenofibric acid.
SUBJECT AND METHODS


Three formulations of fenofibric acid, namely, S-SNEDDS containing medium-chain triglyceride (FS1), S-SNEDDS containing long-chain triglyceride (FS2), and FSt as tablet of innovator product, were used in this study. Bioavailability study was conducted in 12 Indonesian healthy male subjects after a single-dose administration of each formulation with three-way crossover design. Blood samples were collected from 0 to 72 h after drug administration and then analyzed using the high-performance liquid chromatography method. Data were statistically analyzed using the ANOVA and the Wilcoxon signed-rank test using a p value of 0.05. Dissolution test was carried out with USP dissolution apparatus using three medium (pH 1.2, 4.5 and 6.8).
RESULTS


The rates of absorption of fenofibric acid from S-SNEDDS FS1 and FS2 were significantly increased about 1.78 and 2.40 times, respectively, relative to FSt. Tmax values of FS1 and FS2 were shorter than FSt, namely, 0.96 ± 0.438 h (FS1), 0.71 ± 0.445 h (FS2), and 1.71 ± 0.840 h (FSt), respectively. Meanwhile, the Cmax and AUC values of FS1, FS2, and FSt were found to be not significantly different with a p value of >0.05. S-SNEDDS formation increased the dissolution rate in acid medium.
CONCLUSIONS


S-SNEDDS increased the dissolution rate in acid medium and absorption rate of fenofibric acid but did not increase the extent of fenofibric acid absorption.",2022,"The rates of absorption of fenofibric acid from S-SNEDDS FS1 and FS2 were significantly increased about 1.78 and 2.40 times, respectively, relative to FSt.","['Healthy Male Subjects', '12 Indonesian healthy male subjects']","['Solid Self Nanoemulsifying Drug Delivery System (S-SNEDDS', 'fenofibric acid, namely, S-SNEDDS containing medium-chain triglyceride (FS1), S-SNEDDS containing long-chain triglyceride (FS2', 'solid self-nanoemulsifying drug delivery system (S-SNEDDS']","['Cmax and AUC values of FS1, FS2, and FSt', 'Blood samples', 'Tmax values of FS1 and FS2', 'fenofibric acid absorption', 'dissolution rate', 'rates of absorption of fenofibric acid from S-SNEDDS FS1 and FS2', 'dissolution rate in acid medium and absorption rate of fenofibric acid']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}]","[{'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0060179', 'cui_str': 'Fenofibric acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0556091', 'cui_str': 'Long chain triglyceride supplementation'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0118175', 'cui_str': 'fostriecin'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0060179', 'cui_str': 'Fenofibric acid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]",12.0,0.0654152,"The rates of absorption of fenofibric acid from S-SNEDDS FS1 and FS2 were significantly increased about 1.78 and 2.40 times, respectively, relative to FSt.","[{'ForeName': 'Wira Noviana', 'Initials': 'WN', 'LastName': 'Suhery', 'Affiliation': 'Institut Teknologi Bandung, Department of Pharmaceutics, School of Pharmacy, Bandung, Indonesia.'}, {'ForeName': 'Diky', 'Initials': 'D', 'LastName': 'Mudhakir', 'Affiliation': 'Institut Teknologi Bandung, Department of Pharmaceutics, School of Pharmacy, Bandung, Indonesia.'}, {'ForeName': 'Yeyet Cahyati', 'Initials': 'YC', 'LastName': 'Sumirtapura', 'Affiliation': 'Institut Teknologi Bandung, Department of Pharmaceutics, School of Pharmacy, Bandung, Indonesia.'}, {'ForeName': 'Jessie Sofia', 'Initials': 'JS', 'LastName': 'Pamudji', 'Affiliation': 'Institut Teknologi Bandung, Department of Pharmaceutics, School of Pharmacy, Bandung, Indonesia.'}]","Medical principles and practice : international journal of the Kuwait University, Health Science Centre",['10.1159/000522380']
423,35137787,What Should be the First-line Treatment for the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants?,"BACKGROUND


It is important which medicine to use as a first-line treatment to close the duct.
OBJECTIVES


The aim of this study is to compare the effectiveness and side effects of intravenous (IV) forms of ibuprofen and paracetamol and to contribute to the literature investigating the first drug selected in the medical treatment of patent ductus arteriosus (PDA).
METHODS


Our study was conducted between January 2017 and December 2019. Premature infants with birth weight (BW) ≤1500 g and gestational age (GA) ≤32 weeks were included in the study. In the study period, all infants with hemodynamically significant patent ductus arteriosus (hsPDA) were given rescue intravenous (IV) ibuprofen as a primary medical treatment or IV paracetamol treatment if there were contraindications for ibuprofen. The patients were divided into two groups: patients receiving IV ibuprofen and patients receiving IV paracetamol.
RESULTS


Of these patients, 101 were given IV paracetamol and 169 were given IV ibuprofen. The success rate of PDA closure with first-course treatment was 74.3% in the IV paracetamol group and 72.8% in the IV ibuprofen group (p=0.212).
CONCLUSIONS


Our results show that IV paracetamol is as effective as IV ibuprofen in the first-line treatment of hsPDA, and can become the preferred treatment for the management of hsPDA.",2022,"Our results show that IV paracetamol is as effective as IV ibuprofen in the first-line treatment of hsPDA, and can become the preferred treatment for the management of hsPDA.","['January 2017 and December 2019', 'infants with hemodynamically significant patent ductus arteriosus (hsPDA', 'patent ductus arteriosus (PDA', 'BW) ≤1500 g and gestational age (GA) ≤32 weeks were included in the study', 'Premature infants with birth weight']","['ibuprofen', 'paracetamol', 'ibuprofen and paracetamol', 'IV ibuprofen and patients receiving IV paracetamol']",['success rate of PDA closure'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",,0.0563814,"Our results show that IV paracetamol is as effective as IV ibuprofen in the first-line treatment of hsPDA, and can become the preferred treatment for the management of hsPDA.","[{'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Cakir', 'Affiliation': 'Divisão de Neonatologia, Departamento de Pediatria, Health Sciences University, Ankara Bilkent City Hospital, Ankara - Turquia.'}, {'ForeName': 'Cuneyt', 'Initials': 'C', 'LastName': 'Tayman', 'Affiliation': 'Divisão de Neonatologia, Departamento de Pediatria, Health Sciences University, Ankara Bilkent City Hospital, Ankara - Turquia.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20201361']
424,35138211,High Level Mobility Training in Ambulatory Patients with Acquired Non-Progressive Central Neurological Injury: a Feasibility Study.,"The purpose of this study was to test the feasibility and safety of High-Level Mobility (HLM) training on adults with Acquired Brain Injury (ABI). Our hypotheses were that HLM training would be feasible and safe. This study was a pilot randomized control trial with a Simple Skill Group (SSG) and a Complex Skill Group (CSG). Both groups received 12 sessions over 8 weeks and completed 4 testing sessions over 16 weeks. The SSG focused on locomotion, while CSG focused on the acquisition of running. Feasibility was assessed in terms of process, resources, management, and scientific metrics, including safety. Among the 41 participants meeting inclusion criteria, 28 consented (CSG, n = 13, SSG, n = 15), 20 completed the assigned protocol and 8 withdrew (CSG n = 4, SSG n = 4). Adherence rate to assigned protocol was 100%. There were two Adverse Events (AEs), 1 over 142 SSG sessions and 1 over 120 CSG sessions. The AE Odd Ratio (OR) (CSG:SSG) was 1.18 (95% CI: 0.07, 19.15). The data support our hypotheses that HLM training is feasible and safe on ambulatory adults with ABI.",2022,"(CSG:SSG) was 1.18 (95% CI: 0.07, 19.15).","['41 participants meeting inclusion criteria, 28 consented (CSG, n =\xa013, SSG, n =\xa015), 20 completed the assigned protocol and 8 withdrew (CSG n =\xa04, SSG n =\xa04', 'Ambulatory Patients with Acquired Non-Progressive Central Neurological Injury', 'ambulatory adults with ABI', 'adults with Acquired Brain Injury (ABI']","['High Level Mobility Training', 'HLM training', 'High-Level Mobility (HLM) training', 'Simple Skill Group (SSG) and a Complex Skill Group (CSG']","['AE Odd Ratio (OR', 'process, resources, management, and scientific metrics, including safety', 'Adherence rate']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C3839460', 'cui_str': 'Non-progressive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0751792', 'cui_str': 'Injury of nervous system'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",41.0,0.0586671,"(CSG:SSG) was 1.18 (95% CI: 0.07, 19.15).","[{'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Gallo', 'Affiliation': 'Physical Therapy, Rusk Rehabilitation at Nyu Langone Health, New York, USA.'}, {'ForeName': 'Lanqiu', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Population Health, Nyu Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Thaddeus', 'Initials': 'T', 'LastName': 'Tarpey', 'Affiliation': 'Population Health, Nyu Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Cepeda', 'Affiliation': 'Physical Therapy, Rusk Rehabilitation at Nyu Langone Health, New York, USA.'}, {'ForeName': 'Katie Ann', 'Initials': 'KA', 'LastName': 'Connors', 'Affiliation': 'Physical Therapy, Rusk Rehabilitation at Nyu Langone Health, New York, USA.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Kedzierska', 'Affiliation': 'Physical Therapy, Rusk Rehabilitation at Nyu Langone Health, New York, USA.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Physical Therapy, Rusk Rehabilitation at Nyu Langone Health, New York, USA.'}]",Brain injury,['10.1080/02699052.2022.2037710']
425,35139161,Withdrawal of intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy.,"Intravenous immunoglobulins are an efficacious treatment for chronic inflammatory demyelinating polyradiculoneuropathy. Biomarkers for disease activity are lacking, making the need for ongoing treatment difficult to assess, leading to potential overtreatment and high health-care costs. Our objective was to determine whether intravenous immunoglobulin withdrawal is non-inferior to continuing intravenous immunoglobulin treatment and to determine how often patients are overtreated. We performed a randomized, double-blind, intravenous immunoglobulin-controlled non-inferiority trial in seven centres in the Netherlands (Trial registration: ISRCTN 13637698; www.isrctn.com/ISRCTN13637698). Adults with clinically stable chronic inflammatory demyelinating polyradiculoneuropathy using intravenous immunoglobulin maintenance treatment for at least 6 months were included. Patients received either intravenous immunoglobulin withdrawal (placebo) as investigational treatment or continuation of intravenous immunoglobulin treatment (control). The primary outcome was the mean change in logit scores from baseline to 24-week follow-up on the patient-reported Inflammatory Rasch-Overall Disability Scale. The non-inferiority margin was predefined as between-group difference in mean change scores of -0.65. Patients who deteriorated could reach a relapse end point according to predefined criteria. Patients with a relapse end point after intravenous immunoglobulin withdrawal entered a restabilization phase. All patients from the withdrawal group who remained stable were included in an open-label extension phase of 52 weeks. We included 60 patients, of whom 29 were randomized to intravenous immunoglobulin withdrawal and 31 to continuation of treatment. The mean age was 58 years (SD 14.7) and 67% was male. The between-group difference in mean change Inflammatory Rasch-Overall Disability Scale scores was -0.47 (95% CI -1.24 to 0.31), indicating that non-inferiority of intravenous immunoglobulin withdrawal could not be established. In the intravenous immunoglobulin withdrawal group, 41% remained stable for 24 weeks, compared to 58% in the intravenous immunoglobulin continuation group (-17%; 95% CI -39 to 8). Of the intravenous immunoglobulin withdrawal group, 28% remained stable at the end of the extension phase. Of the patients in the restabilization phase, 94% restabilized within 12 weeks. In conclusion, it remains inconclusive whether intravenous immunoglobulin withdrawal is non-inferior compared to continuing treatment, partly due to larger than expected confidence intervals leading to an underpowered study. Despite these limitations, a considerable proportion of patients could stop treatment and almost all patients who relapsed were restabilized quickly. Unexpectedly, a high proportion of intravenous immunoglobulin-treated patients experienced a relapse end point, emphasizing the need for more objective measures for disease activity in future trials, as the patient-reported outcome measures might not have been able to identify true relapses reliably. Overall, this study suggests that withdrawal attempts are safe and should be performed regularly in clinically stable patients.",2022,The between-group difference in mean change iRODS scores was -0.47,"['The mean age was 58 years (SD 14.7) and 67% was male', 'Patients with a relapse endpoint after IVIg withdrawal entered a restabilization phase', 'seven centers in the Netherlands', 'chronic inflammatory demyelinating polyradiculoneuropathy', 'All patients from the withdrawal group who remained stable, were included in an open-label extension phase of 52 weeks', 'Adults with clinically stable CIDP using IVIg maintenance treatment for at least 6 months were included', '60 patients of whom 29 were randomised to IVIg withdrawal and 31 to continuation of treatment']","['intravenous immunoglobulin', 'IVIg withdrawal (placebo', 'Intravenous immunoglobulins (IVIg']","['Inflammatory Rasch-Overall Disability Scale (iRODS', 'mean change iRODS scores', 'mean change in logit scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032587', 'cui_str': 'Polyradiculoneuropathy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",60.0,0.403293,The between-group difference in mean change iRODS scores was -0.47,"[{'ForeName': 'Max E', 'Initials': 'ME', 'LastName': 'Adrichem', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Ilse M', 'Initials': 'IM', 'LastName': 'Lucke', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Alexander F J E', 'Initials': 'AFJE', 'LastName': 'Vrancken', 'Affiliation': 'Department of Neurology, University Medical Centre, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'H Stephan', 'Initials': 'HS', 'LastName': 'Goedee', 'Affiliation': 'Department of Neurology, University Medical Centre, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Luuk', 'Initials': 'L', 'LastName': 'Wieske', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Nicol C', 'Initials': 'NC', 'LastName': 'Voermans', 'Affiliation': 'Department of Neurology, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Nicolette C', 'Initials': 'NC', 'LastName': 'Notermans', 'Affiliation': 'Department of Neurology, University Medical Centre, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Catharina G', 'Initials': 'CG', 'LastName': 'Faber', 'Affiliation': 'Department of Neurology, Maastricht Academic Medical Centre, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Visser', 'Affiliation': 'Department of Neurology, Elisabeth-Tweesteden Hospital, 5022 GC Tilburg, The Netherlands.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Kuitwaard', 'Affiliation': 'Department of Neurology, Albert Schweitzer Hospital, 3318 AT Dordrecht, The Netherlands.'}, {'ForeName': 'Pieter A', 'Initials': 'PA', 'LastName': 'van Doorn', 'Affiliation': 'Department of Neurology, Erasmus Medical Centre, 3015 GD Rotterdam, The Netherlands.'}, {'ForeName': 'Ingemar S J', 'Initials': 'ISJ', 'LastName': 'Merkies', 'Affiliation': 'Department of Neurology, Radboud University Medical Centre, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'de Haan', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Ivo N', 'Initials': 'IN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Eftimov', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}]",Brain : a journal of neurology,['10.1093/brain/awac054']
426,35133471,Bone Turnover Markers After Six Nights of Insufficient Sleep and Subsequent Recovery Sleep in Healthy Men.,"PURPOSE


The goal of this study was to determine the bone turnover marker (BTM) response to insufficient and subsequent recovery sleep, independent of changes in posture, body weight, and physical activity.
METHODS


Healthy men (N = 12) who habitually slept 7-9 h/night were admitted to an inpatient sleep laboratory for a baseline 8 h/night sleep opportunity followed by six nights of insufficient sleep (5 h/night). Diet, physical activity, and posture were controlled. Serum markers of bone formation (osteocalcin, PINP) and resorption (β-CTX) were obtained over 24 h at baseline and on the last night of sleep restriction, and on fasted samples obtained daily while inpatient and five times after discharge over 3 weeks. Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient and subsequent recovery sleep on BTM levels.
RESULTS


There was no statistically or clinically significant change in PINP (p = 0.53), osteocalcin (p = 0.66), or β-CTX (p = 0.10) in response to six nights of insufficient sleep. There were no significant changes in BTMs from the inpatient stay through 3 weeks of recovery sleep (all p [Formula: see text] 0.63). On average, body weight was stable during the inpatient stay (Δweight = - 0.55 ± 0.91 kg, p = 0.06).
CONCLUSION


No significant changes in serum BTMs were observed after six nights of insufficient or subsequent recovery sleep in young healthy men. Changes in weight and physical activity may be required to observe significant BTM change in response to sleep and circadian disruptions. Clinical Trials Registration Registered at ClinicalTrials.gov (NCT03733483) on November 7, 2018.",2022,"Serum markers of bone formation (osteocalcin, PINP) and resorption (β-CTX) were obtained over 24 h at baseline and on the last night of sleep restriction, and on fasted samples obtained daily while inpatient and five times after discharge over 3 weeks.","['young healthy men', 'Healthy men (N\u2009=\u200912) who habitually slept 7-9\xa0h/night were admitted to an inpatient sleep laboratory for a baseline 8\xa0h/night sleep opportunity followed by six nights of insufficient sleep (5\xa0h/night', 'Healthy Men']",[],"['recovery sleep', 'BTMs', 'PINP', 'Serum markers of bone formation (osteocalcin, PINP) and resorption (β-CTX', 'weight and physical activity', 'Bone Turnover Markers', 'posture, body weight, and physical activity', 'body weight', 'serum BTMs', 'osteocalcin', 'bone turnover marker (BTM) response']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0350782,"Serum markers of bone formation (osteocalcin, PINP) and resorption (β-CTX) were obtained over 24 h at baseline and on the last night of sleep restriction, and on fasted samples obtained daily while inpatient and five times after discharge over 3 weeks.","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Swanson', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, 12801 E. 17th Ave, Mail Stop 8106, Aurora, CO, 80045, USA. Christine.Swanson@CUAnschutz.edu.'}, {'ForeName': 'Prajakta', 'Initials': 'P', 'LastName': 'Shanbhag', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, and Eastern Colorado VA Geriatric, Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Tussey', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, and Eastern Colorado VA Geriatric, Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.'}, {'ForeName': 'Corey A', 'Initials': 'CA', 'LastName': 'Rynders', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, and Eastern Colorado VA Geriatric, Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, 12801 E. 17th Ave, Mail Stop 8106, Aurora, CO, 80045, USA.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, and Eastern Colorado VA Geriatric, Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.'}]",Calcified tissue international,['10.1007/s00223-022-00950-8']
427,35141971,Immediate and long-term effects of speech treatment targets and intensive dosage on Parkinson's disease dysphonia and the speech motor network: Randomized controlled trial.,"This study compared acoustic and neural changes accompanying two treatments matched for intensive dosage but having two different treatment targets (voice or articulation) to dissociate the effects of treatment target and intensive dosage in speech therapies. Nineteen participants with Parkinsonian dysphonia (11 F) were randomized to three groups: intensive treatment targeting voice (voice group, n = 6), targeting articulation (articulation group, n = 7), or an untreated group (no treatment, n = 6). The severity of dysphonia was assessed by the smoothed cepstral peak prominence (CPPS) and neuronal changes were evaluated by cerebral blood flow (CBF) recorded at baseline, posttreatment, and 7-month follow-up. Only the voice treatment resulted in significant posttreatment improvement in CPPS, which was maintained at 7 months. Following voice treatment, increased activity in left premotor and bilateral auditory cortices was observed at posttreatment, and in the left motor and auditory cortices at 7-month follow-up. Articulation treatment resulted in increased activity in bilateral premotor and left insular cortices that were sustained at a 7-month follow-up. Activation in the auditory cortices and a significant correlation between the CPPS and CBF in motor and auditory cortices was observed only in the voice group. The intensive dosage resulted in long-lasting behavioral and neural effects as the no-treatment group showed a progressive decrease in activity in areas of the speech motor network out to a 7-month follow-up. These results indicate that dysphonia and the speech motor network can be differentially modified by treatment targets, while intensive dosage contributes to long-lasting effects of speech treatments.",2022,Activation in the auditory cortices and a significant correlation between the CPPS and CBF in motor and auditory cortices was observed only in the voice group.,"[""Parkinson's disease dysphonia and the speech motor network"", 'Nineteen participants with Parkinsonian dysphonia (11\u2009F']","['intensive treatment targeting voice (voice group, n\xa0=\u20096), targeting articulation (articulation group, n\xa0=\u20097), or an untreated group (no treatment, n\xa0=\u20096']","['CPPS', 'cerebral blood flow (CBF', 'CPPS and CBF in motor and auditory cortices', 'smoothed cepstral peak prominence (CPPS) and neuronal changes', 'activity in left premotor and bilateral auditory cortices', 'severity of dysphonia', 'activity in bilateral premotor and left insular cortices']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",19.0,0.0246612,Activation in the auditory cortices and a significant correlation between the CPPS and CBF in motor and auditory cortices was observed only in the voice group.,"[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Narayana', 'Affiliation': 'Department of Pediatrics, Division of Neurology, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Franklin', 'Affiliation': 'Research Imaging Institute, University of Texas Health Science Center, San Antonio, Texas, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Peterson', 'Affiliation': 'LSVT Global Inc, Tucson, Arizona, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Hunter', 'Affiliation': 'Department of Communicative Sciences and Disorders, Michigan State University, Lansing, Michigan, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Robin', 'Affiliation': 'Department of Communication Sciences and Disorders, University of New Hampshire, Durham, New Hampshire, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Halpern', 'Affiliation': 'LSVT Global Inc, Tucson, Arizona, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Spielman', 'Affiliation': 'National Center for Voice and Speech and Department of Speech-Language and Hearing Sciences, University of Colorado-Boulder, Boulder, Colorado, USA.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Fox', 'Affiliation': 'Research Imaging Institute, University of Texas Health Science Center, San Antonio, Texas, USA.'}, {'ForeName': 'Lorraine O', 'Initials': 'LO', 'LastName': 'Ramig', 'Affiliation': 'LSVT Global Inc, Tucson, Arizona, USA.'}]",Human brain mapping,['10.1002/hbm.25790']
428,35134961,"Biomarkers of Exposure and Biomarkers of Potential Harm in Adult Smokers Who Switch to e-Vapor Products Relative to Cigarette Smoking in a 24-week, Randomized, Clinical Trial.","INTRODUCTION


Long-term health effects of e-vapor products (EVPs) are not well-established. We compared biomarkers of exposure (BoE) to select harmful and potentially harmful constituents and biomarkers of potential harm (BoPH) in adult smokers who switched to EVPs versus continued smoking for 24 weeks.
METHODS


Adult smokers (n = 450, >10 cigarettes per day for ≥10 years) were randomly assigned to continue smoking (control) or switch to one of two cartridge-based EVPs (test 1: classic; test 2: menthol, 4% nicotine). BoE and BoPH were measured at baseline and 12 weeks. The results presented here are from a subset of 150 control and EVP subjects (switchers with exhaled carbon monoxide <8 ppm and <10% baseline cigarettes per day) followed for 24 total weeks.
RESULTS


Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and carboxyhemoglobin were significantly reduced (p < .0001) in tests 1 and 2 at 24 weeks. Urinary nicotine equivalents were not statistically significantly different between the control and EVP groups. At week 24, statistically significant reductions (p < .05) were observed for white blood cell counts, 11-dehydrothromboxane β2, and sICAM in both test groups, and there were several significant changes in measures of pulmonary function. High-density lipoprotein cholesterol and 8-epi-prostaglandin-F2α were directionally favorable in both EVP groups versus control.
CONCLUSIONS


We demonstrate that significant reductions of selected harmful and potentially harmful constituents in EVP aerosol results in significant reductions in BoEs and favorable changes in BoPHs after switching to EVPs for 24 weeks. These changes approached those reported for smoking cessation, suggesting that switching to exclusive use of the EVPs may be less harmful than continuing smoking.
IMPLICATIONS


Cigarette smoking causes serious diseases. Switching from cigarettes to a noncombustible product is a potential harm reduction pathway for adult smokers unable or unwilling to quit. Long-term health effects of e-vapor products (EVPs) compared with continued smoking have not been extensively studied. We present biomarker of exposure evidence on select harmful and potentially harmful constituents and biomarkers of potential harm related to inflammation and oxidative stress in adult smokers switching to two EVPs. This study demonstrates significant reductions in biomarkers of exposure (except for nicotine) accompanied with favorable changes in various biomarkers of potential harm, including pulmonary function. The totality of evidence suggests that exclusive EVP use may present lower health risks compared with smoking cigarettes.",2022,"RESULTS


Total NNAL and carboxyhemoglobin (COHb) were significantly reduced (p<0.0001) in Test 1 and Test 2 at 24 weeks.","['adult smokers (AS) who switched to EVPs vs continued smoking for 24 weeks', '150 Control and EVP subjects (switchers with eCO ≤8\xa0ppm and <10% baseline CPD', 'Adult Smokers', 'AS (n=450, >10 cigarettes per day [CPD] for ≥10 years']","['e-vapor products (EVPs', 'EVPs', 'continue smoking (Control) or switch to one of two cartridge-based EVPs (Test 1 - classic; Test 2 - menthol, 4% nicotine']","['BoE and BoPH', 'white blood cell counts, 11-dehydrothromboxane β2, and sICAM', 'health risks', 'Total NNAL and carboxyhemoglobin (COHb', 'High-density lipoprotein-cholesterol (HDL-C) and 8-epi-prostaglandin-F2α', 'pulmonary function', 'Urinary nicotine equivalents (NE']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0597635', 'cui_str': 'Vapor'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2675227', 'cui_str': 'Endocrine-Cerebroosteodysplasia'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0055816', 'cui_str': 'citrate phosphate dextrose'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0597635', 'cui_str': 'Vapor'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-ol'}, {'cui': 'C0007061', 'cui_str': 'Carboxyhemoglobin'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",,0.118543,"RESULTS


Total NNAL and carboxyhemoglobin (COHb) were significantly reduced (p<0.0001) in Test 1 and Test 2 at 24 weeks.","[{'ForeName': 'Jeffery S', 'Initials': 'JS', 'LastName': 'Edmiston', 'Affiliation': 'Altria Client Services LLC, Center for Research and Technology, Richmond, VA, USA.'}, {'ForeName': 'Katy M', 'Initials': 'KM', 'LastName': 'Webb', 'Affiliation': 'Altria Client Services LLC, Center for Research and Technology, Richmond, VA, USA.'}, {'ForeName': 'Jingzhu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Altria Client Services LLC, Center for Research and Technology, Richmond, VA, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Oliveri', 'Affiliation': 'Employees of Altria Client Services LLC at the time of the study.'}, {'ForeName': 'Qiwei', 'Initials': 'Q', 'LastName': 'Liang', 'Affiliation': 'Employees of Altria Client Services LLC at the time of the study.'}, {'ForeName': 'Mohamadi', 'Initials': 'M', 'LastName': 'Sarkar', 'Affiliation': 'Altria Client Services LLC, Center for Research and Technology, Richmond, VA, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntac029']
429,35142713,One Bout of Resistance Training Does Not Enhance Metformin Actions in Prediabetic and Diabetic Individuals.,"PURPOSE


This study aimed to determine the separated and combined effects of metformin and resistance exercise on glycemic control, insulin sensitivity, and insulin-like growth factor 1 (IGF-1) in overweight/obese individuals with prediabetes and type 2 diabetes mellitus.
METHODS


Fourteen adults with a body mass index of 32.1 ± 4.1 kg·m-2, insulin resistance (HOMA-2 1.6 ± 0.6), and poor glycemic control (glycated hemoglobin, 6.9% ± 0.9%; 51.9 ± 10.7 mmol·mol-1) while taking metformin (1561 ± 470 g·d-1) were recruited. Participants underwent four 72-h long experimental trials in a randomized counterbalanced order, either 1) taking metformin (MET), 2) replacing metformin by placebo pills (PLAC), 3) taking placebo and undergoing a resistance training bout (RT + PLAC), and 4) taking metformin and undergoing the same RT bout (RT + MET). Interstitial fluid glucose concentration was frequently sampled to obtain 72-h glucose area under the curve (GAUC) and the percentage hyperglycemic glucose readings (>180 mg·dL-1; GPEAKS). Insulin sensitivity (i.e., HOMA-2) and IGF-1 were also assessed.
RESULTS


HOMA-2 was not affected by treatments. GAUC and GPEAKS were similarly reduced below PLAC during RT + MET and MET (all P < 0.05). In contrast, RT + PLAC did not affect glucose concentration. Metformin decreased serum IGF-1 concentrations (P = 0.006), and RT did not reverse this reduction.
CONCLUSIONS


A bout of full-body RT does not interfere or aid on metformin's blood glucose-lowering actions in individuals with prediabetes and type 2 diabetes mellitus.",2022,"Metformin decreased serum IGF-1 concentrations (P = 0.006) and RT did not reverse this reduction.
","['individuals with pre-and-T2DM', 'overweight/obese individuals with pre-and-T2DM.\nMETHODS\n\n\n14 adults with BMI of 32.1 ± 4.1 kg·m-2, insulin resistance (HOMA-2 1.6 ± 0.6) and poor glycemic control ', '1561 ± 470 g·day-1) were recruited', 'Pre- and Diabetic Individuals']","['RT + PLAC', 'metformin', 'metformin and resistance exercise', 'Metformin', 'metformin (MET), 2) replacing metformin by placebo pills (PLAC), 3) taking placebo and undergoing a resistance training bout (RT + PLAC), and 4) taking metformin and undergoing the same RT bout (RT + MET', 'Resistance Training']","['glycemic control, insulin sensitivity and insulin-like growth factor 1 (IGF-1', 'Interstitial fluid glucose concentration', 'Insulin sensitivity (i.e., HOMA-2) and IGF-1', 'glucose concentration', 'percentage hyperglycemic glucose readings', 'serum IGF-1 concentrations']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0048838', 'cui_str': ""5'-palmitoyl cytarabine""}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C2586119', 'cui_str': 'Interstitial fluid glucose concentration'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",14.0,0.0647099,"Metformin decreased serum IGF-1 concentrations (P = 0.006) and RT did not reverse this reduction.
","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Toledo, SPAIN.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': ''}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Alvarez-Jimenez', 'Affiliation': ''}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002889']
430,35142710,Effects of Aerodynamic Drag and Drafting on Propulsive Force and Oxygen Consumption in Double Poling Cross-Country Skiing.,"PURPOSE


This study aimed to investigate the effects of aerodynamic drag and drafting on propulsive force (FPROP), drag area (CDA), oxygen cost (V˙O2), metabolic rate (E˙), and heart rate (HR) during roller skiing on a treadmill in a wind tunnel using the double poling technique. A secondary aim was to investigate the effects of wind versus no-wind test conditions on the same physiological parameters.
METHODS


Ten subjects of each gender participated in the experiments. One pair of skiers of the same gender roller skied simultaneously in line with the air flow; the distance between the skiers was ~2.05 m. Each pair was tested as follows: I) with wind, leading; II) with wind, drafting; and III) without wind. The treadmill inclination was 0° throughout the tests. For the wind conditions, the air velocity was similar to the treadmill belt speed: 3 to 7 m·s-1 for men and 3 to 6 m·s-1 for women.
RESULTS


Drafting resulted in significantly (P < 0.05) lower FPROP,CDA, V˙O2, and E˙, compared with leading, for both genders at racing speed but not at lower speeds, whereas HR was only affected for the male skiers at racing speed. The test without wind resulted in significantly lower FPROP, V˙O2, and E˙ at all tested speeds compared with the tests with wind present, whereas HR was lower only at higher speeds.
CONCLUSIONS


At racing speed, but not at lower speeds, the positive effects of drafting behind a skier during double poling were obvious and resulted in a lower FPROP, CDA, V˙O2, E˙, and HR. Tests without wind present put even lower demands on the skiers' physiology, which was also evident at lower speeds.",2022,"RESULTS


Drafting resulted in significantly (P < 0.05) lower FPROP, CDA, V˙O2 and E˙, compared to leading, for both genders at racing speed but not at lower speeds, while HR was only affected for the male skiers at racing speed.","['10 subjects of each gender participated in the experiments', 'Double Poling Cross-country Skiing']","['roller skiing on a treadmill in a wind tunnel using the double poling technique', 'Aerodynamic Drag and Drafting']","['FPROP, V˙O2 and E˙', 'Propulsive Force and Oxygen Consumption', 'lower FPROP, CDA, V˙O2, E˙ and HR', 'FPROP, CDA, V˙O2 and E˙', 'air velocity', 'propulsive force (FPROP), drag area (CDA), oxygen cost (V˙O2), metabolic rate (E˙) and heart rate (HR']","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0037264', 'cui_str': 'Skiing'}]","[{'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0037264', 'cui_str': 'Skiing'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1562415', 'cui_str': 'Skin drag'}]","[{'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002876', 'cui_str': 'Congenital dyserythropoietic anemia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1562415', 'cui_str': 'Skin drag'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",10.0,0.125849,"RESULTS


Drafting resulted in significantly (P < 0.05) lower FPROP, CDA, V˙O2 and E˙, compared to leading, for both genders at racing speed but not at lower speeds, while HR was only affected for the male skiers at racing speed.","[{'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Ainegren', 'Affiliation': 'Sports Tech Research Centre, Department of Quality Technology and Mechanical Engineering, Mid Sweden University, Östersund, SWEDEN.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Linnamo', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, FINLAND.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lindinger', 'Affiliation': 'Center for Health and Performance, Department of Food and Nutrition and Sport Science, University of Gothenburg, Gothenburg, SWEDEN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002885']
431,35134184,Effects of Dapagliflozin and Combination Therapy With Exenatide on Food-Cue Induced Brain Activation in Patients With Type 2 Diabetes.,"CONTEXT


Sodium-glucose cotransporter-2 inhibitors (SGLT2i) cause less weight loss than expected based on urinary calorie excretion. This may be explained by SGLT2i-induced alterations in central reward and satiety circuits, leading to increased appetite and food intake. Glucagon-like peptide-1 receptor agonists are associated with reduced appetite and body weight, mediated by direct and indirect central nervous system (CNS) effects.
OBJECTIVE


We investigated the separate and combined effects of dapagliflozin and exenatide on the CNS in participants with obesity and type 2 diabetes.
METHODS


This was a 16-week, double-blind, randomized, placebo-controlled trial. Obese participants with type 2 diabetes (n = 64, age 63.5 ± 0.9 years, BMI 31.7 ± 0.6 kg/m2) were randomized (1:1:1:1) to dapagliflozin 10 mg with exenatide-matched placebo, exenatide twice daily 10 µg with dapagliflozin-matched placebo, dapagliflozin and exenatide, or double placebo. Using functional MRI, the effects of treatments on CNS responses to viewing food pictures were assessed after 10 days and 16 weeks of treatment.
RESULTS


After 10 days, dapagliflozin increased, whereas exenatide decreased CNS activation in the left putamen. Combination therapy had no effect on responses to food pictures. After 16 weeks, no changes in CNS activation were observed with dapagliflozin, but CNS activation was reduced with dapagliflozin-exenatide in right amygdala.
CONCLUSION


The early increase in CNS activation with dapagliflozin may contribute to the discrepancy between observed and expected weight loss. In combination therapy, exenatide blunted the increased CNS activation observed with dapagliflozin. These findings provide further insights into the weight-lowering mechanisms of SGLT2i and GLP-1 receptor agonists.",2022,"After 16 weeks, no changes in CNS activation were observed with dapagliflozin, but CNS activation was reduced with dapagliflozin-exenatide in right amygdala.
","['participants with obesity and type 2 diabetes', 'Obese participants with type 2 diabetes', 'patients with type 2 diabetes']","['placebo', 'exenatide', 'dapagliflozin', 'dapagliflozin and combination therapy with exenatide', 'dapagliflozin 10mg with exenatide-matched placebo, exenatide twice-daily 10µg with dapagliflozin-matched placebo, dapagliflozin and exenatide, or double placebo', 'dapagliflozin-exenatide', 'dapagliflozin and exenatide']","['food-cue induced brain activation', 'CNS activation', 'responses to food pictures']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",,0.340661,"After 16 weeks, no changes in CNS activation were observed with dapagliflozin, but CNS activation was reduced with dapagliflozin-exenatide in right amygdala.
","[{'ForeName': 'Charlotte C', 'Initials': 'CC', 'LastName': 'van Ruiten', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, location VU University Medical Center, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Dick J', 'Initials': 'DJ', 'LastName': 'Veltman', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, location VU University Medical Center, 1081 HJ Amsterdam, The Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Schrantee', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, location Academic Medical Center, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'van Bloemendaal', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, location VU University Medical Center, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, location VU University Medical Center, 1081 BT Amsterdam, The Netherlands.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, location VU University Medical Center, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, location VU University Medical Center, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'IJzerman', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Center, location VU University Medical Center, 1081 HV Amsterdam, The Netherlands.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac043']
432,35142924,Randomized clinical trial comparing monolithic and veneered zirconia three-unit posterior fixed partial dentures in a complete digital flow: three-year follow-up.,"OBJECTIVES


To evaluate and to compare the clinical performance and survival rate of posterior monolithic and veneered zirconia fixed partial dentures (FPDs).
MATERIAL AND METHODS


Sixty 3-unit posterior FPDs were included in the study. The patients were randomly distributed into two groups (n = 30 each) to receive either a monolithic (Zenostar T, Wieland Dental) or veneered zirconia (IPS e.max ZirCAD, Ivoclar Vivadent) FPD. Each patient received only 1 FPD. Tooth preparations were scanned (Trios 3, 3Shape), designed (Dental System 2016, 3 Shape), milled (Zenotec CAM 3.2, Wieland Dental), and cemented with a resin cement. Technical and biological outcomes and periodontal parameters were assessed. Data analysis was made using the Friedman and the Wilcoxon signed-rank tests with the Bonferroni correction and the Mann-Whitney U test.
RESULTS


The survival rate at 3 years was 100% for veneered and 90% for monolithic zirconia restorations. Three monolithic zirconia FPDs were lost because of biologic complications. The main complication in the veneered zirconia FPDs was the fracture of the veneering ceramic in 4 of the veneered zirconia FPDs. No fracture of the frameworks was observed in any of the groups. All restorations were assessed as satisfactory after 3 years. No differences in periodontal parameters were observed between the groups.
CONCLUSIONS


The results of this study suggest that monolithic zirconia and complete digital flow could be a viable alternative to veneered zirconia in the posterior regions.
CLINICAL RELEVANCE


The monolithic zirconia restorations with a digital workflow can be a viable alternative in posterior fixed partial dentures, with good periodontal outcomes.
CLINICAL TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (Identifier NCT 04,879,498).",2022,"The monolithic zirconia restorations with a digital workflow can be a viable alternative in posterior fixed partial dentures, with good periodontal outcomes.
",['Sixty 3-unit posterior FPDs were included in the study'],"['monolithic and veneered zirconia three-unit posterior fixed partial dentures', 'monolithic (Zenostar T, Wieland Dental) or veneered zirconia (IPS e.max ZirCAD, Ivoclar Vivadent) FPD', 'posterior monolithic and veneered zirconia fixed partial dentures (FPDs']","['periodontal parameters', 'survival rate']","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0801268,"The monolithic zirconia restorations with a digital workflow can be a viable alternative in posterior fixed partial dentures, with good periodontal outcomes.
","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Pontevedra', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, Faculty of Odontology, University Complutense of Madrid, Pza Ramon y Cajal s/n, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lopez-Suarez', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, Faculty of Odontology, University Complutense of Madrid, Pza Ramon y Cajal s/n, Madrid, Spain.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, Faculty of Odontology, University Complutense of Madrid, Pza Ramon y Cajal s/n, Madrid, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Pelaez', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, Faculty of Odontology, University Complutense of Madrid, Pza Ramon y Cajal s/n, Madrid, Spain. jpelaezr@ucm.es.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Suarez', 'Affiliation': 'Department of Conservative Dentistry and Buccofacial Prostheses, Faculty of Odontology, University Complutense of Madrid, Pza Ramon y Cajal s/n, Madrid, Spain.'}]",Clinical oral investigations,['10.1007/s00784-022-04396-y']
433,35142923,Thirty-six-month follow-up of cervical composite restorations placed with an MDP-free universal adhesive system using different adhesive protocols: a randomized clinical trial.,"OBJECTIVES


To evaluate the influence of different application strategies on the clinical behavior of an MDP-free universal adhesive placed in non-carious cervical lesions (NCCLs) over the course of 36 months.
MATERIALS AND METHODS


Thirty-one patients participated in this study (N = 31). One hundred twenty-four restorations were assigned to four groups: We used the self-etch strategy on groups with (SE-et) and without (SET) selective enamel etching, and the etch-and-rinse strategy on groups with dry (ER-D) and moist (ER-M) dentin. After applying the MDP-free universal adhesive (Xeno Select universal adhesive, Dentsply Sirona), cavities were filled using EvoluX composite resin (Dentsply Sirona). The restorations were evaluated at baseline and after 36 months according to World Dental Federation (FDI) and US Public Health Service (USPHS) criteria. Friedman's repeated-measures analysis of variance rank (α = 0.05) was used for statistical analysis.
RESULTS


We evaluated the 31 patients after 36 months. Forty-two restorations were lost (ER-D = 5, ER-M = 7, SE-et = 14, SET = 16). The 36-month retention/fracture rates (95% confidence interval) were 83.9% for ER-D, 77.4% for ER-M, 54.9% for SE-et, and 48.4% for SET. ER strategy showed better retention rate than SE strategy (p < 0.05). Thirty-four restorations (ER-D = 6, ER-M = 10, SE-et = 10, SET = 8) showed marginal staining per FDI criteria and 15 restorations (ER-D = 1, ER-M = 2, SE-et = 6, SET = 6) showed marginal staining per USPHS criteria. No restorations showed postoperative sensitivity or recurrence of caries.
CONCLUSION


The retention rate of Xeno Select universal adhesive was poor, mainly in the self-etch strategy.
TRIAL REGISTRATION


REBEC clinical registry under protocol RBR-4wh4sh.
CLINICAL RELEVANCE


MDP-free universal adhesive behavior depends on the bonding strategy used.",2022,ER strategy showed better retention rate than SE strategy (p < 0.05).,"['31 patients after 36\xa0months', 'Thirty-one patients participated in this study (N\u2009=\u200931', 'One hundred twenty-four restorations']","['MDP-free universal adhesive system', 'self-etch strategy on groups with (SE-et) and without (SET) selective enamel etching, and the etch-and-rinse strategy on groups with dry (ER-D) and moist (ER-M) dentin', 'MDP-free universal adhesive placed']","['retention rate', 'retention rate of Xeno Select universal adhesive', 'postoperative sensitivity or recurrence of caries', '36-month retention/fracture rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0052834', 'cui_str': 'B 30-muramyl dipeptide'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",124.0,0.113113,ER strategy showed better retention rate than SE strategy (p < 0.05).,"[{'ForeName': 'Marcos O', 'Initials': 'MO', 'LastName': 'Barceleiro', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Fluminense Federal University, Nova Friburgo, Brazil.'}, {'ForeName': 'Leticia S', 'Initials': 'LS', 'LastName': 'Lopes', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Rio de Janeiro State University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Chane', 'Initials': 'C', 'LastName': 'Tardem', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Fluminense Federal University, Nova Friburgo, Brazil.'}, {'ForeName': 'Fernanda S', 'Initials': 'FS', 'LastName': 'Calazans', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Fluminense Federal University, Nova Friburgo, Brazil.'}, {'ForeName': 'Thalita P', 'Initials': 'TP', 'LastName': 'Matos', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Tuiuti University of Paraná, Curitiba, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Abraham Lincoln', 'Initials': 'AL', 'LastName': 'Calixto', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil. aloguercio@hotmail.com.'}]",Clinical oral investigations,['10.1007/s00784-022-04397-x']
434,35143747,"Effects of the Robot-Assisted Gait Training Device Plus Physiotherapy in Improving Ambulatory Functions in Patients With Subacute Stroke With Hemiplegia: An Assessor-Blinded, Randomized Controlled Trial.","OBJECTIVE


To investigate the effects of the robot-assisted gait training (RAGT) device plus physiotherapy vs physiotherapy alone in improving ambulatory functions in patients with subacute stroke with hemiplegia.
DESIGN


A prospective, assessor-blinded, randomized controlled trial.
SETTING


Patients with subacute stroke with hemiplegia admitted at the Rehabilitation Center.
PARTICIPANTS


Twenty-six patients with subacute stroke with hemiplegia (N=26).
INTERVENTION


All patients received 30 training sessions (5 d/wk for 6 wk), which included conventional physiotherapy training (60 minutes) and ambulation training (60 minutes). In the ambulation training session, the RAGT device group received robotic training (40 minutes) and ground ambulation training (20 minutes). The control group received only ground ambulation training (60 minutes). The outcomes were assessed at the initial session and at the end of the 15 th  and 30 th  sessions. Comparisons within groups and between groups were conducted.
MAIN OUTCOME MEASURES


Primary outcome variables were the FIM-walk score and the efficacy of FIM-walk.
RESULTS


The RAGT device group showed greater improvements from baseline than control in (1) the FIM-walk score at the end of the 15 th  session (P=.012), (2) the efficacy of FIM-walk at the end of the 15 th  session (P=.008), (3) walking distance in the 6-minute walk test at the end of the 15 th  session (P=.018), (4) the Barthel Index for Activities of Daily Living (ADL) at the end of the 30 th  session (P<.001), and (5) gait symmetry ratio at the end of the 30 th  session (P=.044). Other gait parameters showed tendencies of improvement in the RAGT device group, but there were no significant differences.
CONCLUSIONS


RAGT devices plus physiotherapy showed early improvements in walking ability and Barthel ADL index compared with the ground level training plus physiotherapy in patients with subacute stroke with hemiplegia.",2022,"The RAGTD group showed greater improvements from baseline than control in: (1) the FIM-walk score, at the end of the 15 th  session (p = 0.012), (2) the efficacy of FIM-walk, at the end of the 15 th  session (p = 0.008), (3) walking distance in the 6-minute walk test (6MWT), at the end of the 15 th  session (p = 0.018), (4) the Barthel Index for Activities of Daily Living (ADL), at the end of the 30 th  session (p < 0.001), and (5) gait symmetry ratio, at the end of the 30 th  session (p = 0.044).","['Twenty-six subacute stroke patients with hemiplegia', 'Subacute stroke patients with hemiplegia admitted at the Rehabilitation Center', 'subacute stroke patients with hemiplegia']","['robotic training (40 min) and ground ambulation training', 'conventional physiotherapy training (60 min) and ambulation training', 'robot-assisted gait training device plus physiotherapy', 'ground ambulation training', 'robot-assisted gait training device (RAGTD) plus physiotherapy versus physiotherapy alone', '30 training sessions']","['Functional Independence Measure (FIM)-walk score and the efficacy of FIM-walk', 'walking ability and Barthel ADL index', 'Barthel Index for Activities of Daily Living (ADL', 'FIM-walk score', 'walking distance in the 6-minute walk test (6MWT', 'efficacy of FIM-walk', 'ambulatory functions']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1276390', 'cui_str': 'Ambulation training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0203965', 'cui_str': 'Physiotherapy training'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0688326,"The RAGTD group showed greater improvements from baseline than control in: (1) the FIM-walk score, at the end of the 15 th  session (p = 0.012), (2) the efficacy of FIM-walk, at the end of the 15 th  session (p = 0.008), (3) walking distance in the 6-minute walk test (6MWT), at the end of the 15 th  session (p = 0.018), (4) the Barthel Index for Activities of Daily Living (ADL), at the end of the 30 th  session (p < 0.001), and (5) gait symmetry ratio, at the end of the 30 th  session (p = 0.044).","[{'ForeName': 'Natapatchakrid', 'Initials': 'N', 'LastName': 'Thimabut', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pattarapol', 'Initials': 'P', 'LastName': 'Yotnuengnit', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Charoenlimprasert', 'Affiliation': 'Thai Red Cross Rehabilitation Center, Thai Red Cross Society, Samut Prakan, Thailand.'}, {'ForeName': 'Thipwimon', 'Initials': 'T', 'LastName': 'Sillapachai', 'Affiliation': 'Thai Red Cross Rehabilitation Center, Thai Red Cross Society, Samut Prakan, Thailand.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hirano', 'Affiliation': 'Department of Rehabilitation Medicine Ι, School of Medicine, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Saitoh', 'Affiliation': 'Department of Rehabilitation Medicine Ι, School of Medicine, Fujita Health University, Toyoake, Japan.'}, {'ForeName': 'Krisna', 'Initials': 'K', 'LastName': 'Piravej', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: kppmrchula@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2022.01.146']
435,35146797,Night-time gastric acid suppression by tegoprazan compared to vonoprazan or esomeprazole.,"AIMS


Nocturnal acid breakthrough has been considered an unmet need of proton-pump inhibitors. Tegoprazan, a novel potassium-competitive acid blocker, is expected to show improved properties for this unmet need. This study was aimed to compare night-time acid suppression by tegoprazan with that by vonoprazan or esomeprazole, and to explore the effect of CYP2C19 phenotypes on acid-suppressive effects.
METHODS


A randomized, open-label, 3-period, 6-sequence crossover study was conducted. A single oral dose of tegoprazan 50 mg, vonoprazan 20 mg or esomeprazole 40 mg was administered at night in each period. Continuous intragastric pH was monitored at baseline and after each dosing.
RESULTS


Sixteen healthy subjects (6 CYP2C19 extensive metabolizers, 5 intermediate metabolizers, 5 poor metabolizers) completed the study. After a single dose of tegoprazan, intragastric pH increased more rapidly to over 4 at approximately 1 hour compared to the other treatments, and elevated intragastric pH was maintained stably at night. Tegoprazan exhibited night-time acid suppression for slightly but not significantly longer than vonoprazan, and greater than esomeprazole; % time at pH ≥ 4 at night was 66.0%, 60.5% and 36.1% for tegoprazan, vonoprazan and esomeprazole, respectively. Night-time acid suppression by tegoprazan and vonoprazan was not dependent on CYP2C19 phenotypes, while that by esomeprazole tended to be influenced by CYP2C19 phenotypes.
CONCLUSION


Tegoprazan produced more rapid, potent and well sustained night-time acid suppression vs. vonoprazan or esomeprazole when administered at night. Furthermore, tegoprazan showed no CYP2C19 phenotype dependency in acid suppression. It suggests the potential of tegoprazan, especially in preventing nocturnal acid breakthrough.",2022,"Night-time acid suppression by tegoprazan and vonoprazan was not dependent on CYP2C19 phenotypes, while that by esomeprazole tended to be influenced by CYP2C19 phenotypes.
","['16 healthy subjects (6 CYP2C19 extensive metabolizers, 5 intermediate metabolizers, 5 poor metabolizers) completed the study']","['tegoprazan', 'Tegoprazan', 'esomeprazole', 'tegoprazan, intragastric pH', 'vonoprazan or esomeprazole', 'tegoprazan 50 mg, vonoprazan 20 mg or esomeprazole']","['Tegoprazan exhibited night-time acid suppression', 'Continuous intragastric pH', 'elevated intragastric pH', 'Night-time acid suppression', 'Night-time gastric acid suppression']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4726822', 'cui_str': 'tegoprazan'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C4726822', 'cui_str': 'tegoprazan'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017119', 'cui_str': 'Gastric acid'}]",16.0,0.0453511,"Night-time acid suppression by tegoprazan and vonoprazan was not dependent on CYP2C19 phenotypes, while that by esomeprazole tended to be influenced by CYP2C19 phenotypes.
","[{'ForeName': 'Eunsol', 'Initials': 'E', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seokuee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Clinical Development, HK inno. N Corp., Seoul, Republic of Korea.'}, {'ForeName': 'Bongtae', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Division of Clinical Development, HK inno. N Corp., Seoul, Republic of Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Laboratory Medicine, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yechan', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Laboratory Medicine, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Sup', 'Initials': 'SS', 'LastName': 'Park', 'Affiliation': 'Department of Laboratory Medicine, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Geun Seog', 'Initials': 'GS', 'LastName': 'Song', 'Affiliation': 'Division of Clinical Development, HK inno. N Corp., Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]",British journal of clinical pharmacology,['10.1111/bcp.15268']
436,35143411,Evaluation of prolonged immersion in tricaine methanesulfonate for juvenile goldfish (Carassius auratus) euthanasia.,"OBJECTIVE


Doses of buffered tricaine methanesulfonate (MS-222) up to 1000 mg/L for 15 minutes are reported inefficient to produce euthanasia in goldfish. The goal of this study was to determine if goldfish can be euthanized by more prolonged immersion in MS-222.
ANIMALS


24 healthy goldfish (weight range: 1 to 10 g) were randomly assigned to 4 groups of 6 fish.
PROCEDURES


The first group (G1) was exposed to 500 mg/L buffered MS-222 for 15 minutes then placed in freshwater for 3 hours. The second (G2) and third groups (G3) were exposed to 1000 mg/L of buffered MS-222 for 15 minutes then placed in freshwater for 3 hours and 18 hours respectively. The fourth group (G4) was exposed to 1000 mg/L of buffered MS-222 for 60 minutes then placed in freshwater for 3 hours. Time to cessation and return of operculation were recorded. If the goldfish did not resume operculation, heart rate was evaluated by Doppler ultrasonic flow detector.
RESULTS


Median times to apnea were 35 seconds at 1000 mg/L and 65 seconds at 500 mg/L. Re-operculation occurred only in G1 in 5 out of 6 individuals. All fish from G1, 3 fish from G2, 0 fish from G3, 1 fish from G4 had remaining heartbeats at the end of the observation period.
CLINICAL RELEVANCE


Overall, a dose of 1000 mg/L of buffered MS-222 for 15 minutes was efficient to euthanize juvenile goldfish at 20 °C. Different fish body mass and water quality parameters might explain different results compared to previous studies.",2022,"RESULTS


Median times to apnea were 35 seconds at 1000 mg/L and 65 seconds at 500 mg/L. Re-operculation occurred only in G1 in 5 out of 6 individuals.",['24 healthy goldfish (weight range: 1 to 10 g'],['buffered tricaine methanesulfonate (MS-222'],"['operculation, heart rate', 'Time to cessation and return of operculation', 'Median times to apnea']","[{'cui': 'C0018038', 'cui_str': 'Carassius auratus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1318182', 'cui_str': '10G'}]","[{'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0521934', 'cui_str': 'Tricaine methanesulfonate'}, {'cui': 'C0129157', 'cui_str': 'MS-222'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]",,0.0468546,"RESULTS


Median times to apnea were 35 seconds at 1000 mg/L and 65 seconds at 500 mg/L. Re-operculation occurred only in G1 in 5 out of 6 individuals.","[{'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Perret-Thiry', 'Affiliation': 'Centre Hospitalier Universitaire Vétérinaire, Faculté de médecine vétérinaire, Université de Montréal, St-Hyacinthe, Québec, Canada.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Raulic', 'Affiliation': 'Department of Clinical Sciences, Faculté de médecine vétérinaire, Université de Montréal, St-Hyacinthe, Québec, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vergneau-Grosset', 'Affiliation': 'Department of Clinical Sciences, Faculté de médecine vétérinaire, Université de Montréal, St-Hyacinthe, Québec, Canada.'}]",Journal of the American Veterinary Medical Association,['10.2460/javma.21.09.0416']
437,35144570,Investigating the effect of inquiry-based stress reduction on mortality awareness and interpersonal problems among intensive care unit nurses.,"INTRODUCTION


Caring for dying patients is one of the job stressors. Nurses in intensive care units are among the medical staff who have a close interaction with dying patients. Studies have shown that psychological interventions are very helpful in improving thinking about death and its problems. Therefore, this study was conducted to investigate the effect of Inquiry-Based Stress Reduction on mortality awareness and interpersonal problems among intensive care unit nurses in southeastern Iran.
MATERIALS AND METHODS


This was a Quasi-experimental study with a pretest-posttest design in southeast of Iran in 2021. Nurses were selected using the convenience sampling method and divided into intervention (n = 32) and control (n = 35) groups using the block randomization method. The intervention group received a two-hour Inquiry-Based Stress Reduction counseling session every week for 6 weeks. Data were gathered using Multidimensional Mortality Awareness Measure and Inventory of Interpersonal Problems before, immediately after, and 6 weeks after the intervention. IBM SPSS Statistics software version 25 was used for data analysis.
RESULTS


In the intervention group, the mean scores of Mortality Awareness before, immediately after, and 6 weeks after the intervention were 130.41 ± 5.91, 164.47 ± 8.66, and 163.91 ± 9.29, respectively. Therefore, in the intervention group, the increase of Mortality Awareness mean score was statistically significant (P < 0.001). In the control group, the mean scores of Mortality Awareness before, immediately after, and 6 weeks after intervention were 129.63 ± 5.59, 135.26 ± 11.14, and 132.66 ± 5.62, respectively. Difference between the two groups was significant (P < 0.001). The results also showed that in the intervention group the mean scores of Interpersonal Problems immediately after and 6 weeks after the intervention were lower than before the intervention (P < 0.001). In the control group, Interpersonal Problems increased over time (P < 0.001). Accordingly, the difference between the two groups in terms of Interpersonal Problems during the study was statistically significant (P < 0.001).
CONCLUSION


The study results suggest that the Inquiry-Based Stress Reduction is an appropriate intervention method to improve mortality awareness and reduce interpersonal problems in intensive care unit nurses.",2022,"Therefore, in the intervention group, the increase of Mortality Awareness mean score was statistically significant (P < 0.001).","['southeast of Iran in 2021', 'intensive care unit nurses', 'intensive care unit nurses in southeastern Iran']","['two-hour Inquiry-Based Stress Reduction counseling session', 'Inquiry-Based Stress Reduction', 'inquiry-based stress reduction']","['interpersonal problems', 'Mortality Awareness mean score', 'Interpersonal Problems', 'mortality awareness and interpersonal problems', 'mortality awareness', 'mean scores of Mortality Awareness', 'Multidimensional Mortality Awareness Measure and Inventory of Interpersonal Problems', 'mean scores of Interpersonal Problems']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",2021.0,0.0122644,"Therefore, in the intervention group, the increase of Mortality Awareness mean score was statistically significant (P < 0.001).","[{'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Tajnia', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Iranmanesh', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran. n.asadi@kmu.ac.ir.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McDermott', 'Affiliation': 'University of East London (UEL), London, UK.'}]",BMC psychiatry,['10.1186/s12888-022-03764-y']
438,35147813,A Randomized Controlled Trial Comparing Neurofeedback and Cognitive-Behavioral Therapy for Insomnia Patients: Pilot Study.,"Insomnia is a common disease that negatively affects patients both mentally and physically. While insomnia disorder is mainly characterized by hyperarousal, a few studies that have directly intervened with cortical arousal. This study was conducted to investigate the effect of a neurofeedback protocol for reducing cortical arousal on insomnia compared to cognitive-behavioral treatment for insomnia (CBT-I). Seventeen adults with insomnia, free of other psychiatric illnesses, were randomly assigned to neurofeedback or CBT-I. All participants completed questionnaires on insomnia [Insomnia Severity Index (ISI)], sleep quality [Pittsburgh Sleep Quality Index (PSQI)], and dysfunctional cognition [Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)]. The neurofeedback group showed decreases in beta waves and increases in theta and alpha waves in various areas of the electroencephalogram (EEG), indicating lowered cortical arousal. The ISI and PSQI scores were significantly decreased, and sleep efficiency and sleep satisfaction were increased compared to the pre-treatment scores in both groups. DBAS scores decreased only in the CBT-I group (NF p = 0.173; CBT-I p = 0.012). This study confirmed that neurofeedback training could alleviate the symptoms of insomnia by reducing cortical hyperarousal in patients, despite the limited effect in reducing cognitive dysfunction compared to CBT-I.",2022,"The neurofeedback group showed decreases in beta waves and increases in theta and alpha waves in various areas of the electroencephalogram (EEG), indicating lowered cortical arousal.","['Seventeen adults with insomnia, free of other psychiatric illnesses', 'insomnia (CBT-I', 'Insomnia Patients']","['neurofeedback training', 'neurofeedback protocol', 'Neurofeedback and Cognitive-Behavioral Therapy', 'neurofeedback or CBT-I']","['cortical arousal', 'beta waves and increases in theta and alpha waves in various areas of the electroencephalogram (EEG', 'insomnia [Insomnia Severity Index (ISI)], sleep quality [Pittsburgh Sleep Quality Index (PSQI)], and dysfunctional cognition [Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16', 'ISI and PSQI scores', 'sleep efficiency and sleep satisfaction', 'cortical arousal on insomnia', 'DBAS scores']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025923', 'cui_str': 'Mouse, Inbred DBA'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",17.0,0.0248871,"The neurofeedback group showed decreases in beta waves and increases in theta and alpha waves in various areas of the electroencephalogram (EEG), indicating lowered cortical arousal.","[{'ForeName': 'Yunna', 'Initials': 'Y', 'LastName': 'Kwan', 'Affiliation': ""Department of Psychology, Duksung Women's University, Seoul, Republic of Korea.""}, {'ForeName': 'Soyoung', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': ""Department of Psychology, Duksung Women's University, Seoul, Republic of Korea.""}, {'ForeName': 'Sooyeon', 'Initials': 'S', 'LastName': 'Suh', 'Affiliation': ""Department of Psychology, Sungshin Women's University, Seoul, Republic of Korea.""}, {'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': ""Department of Psychology, Duksung Women's University, Seoul, Republic of Korea. karatt92@duksung.ac.kr.""}]",Applied psychophysiology and biofeedback,['10.1007/s10484-022-09534-6']
439,35149905,Chemical analysis of irradiated root dentin and its interaction with resin cements.,"OBJECTIVES


To investigate the chemical changes in root dentin submitted to ionizing radiation and how it affects the interaction with resin cements.
MATERIALS AND METHODS


Forty human premolars were randomly divided into two groups (n = 20): non-irradiated and irradiated. They were randomly subdivided according to the type of resin cement (n = 10): conventional (RelyX ARC, 3 M ESPE) or self-adhesive (RelyX U200, 3 M ESPE). After cementation of the fiberglass posts, the roots were sectioned to be analyzed by Fourier transform infrared spectroscopy (FTIR), Raman spectroscopy, and confocal laser scanning microscopy (CLSM). The data obtained from FTIR and Raman were analyzed using two-way ANOVA followed Tukey's test (α = 0.05). For CLSM, a descriptive analysis was performed.
RESULTS


In the FTIR, there was a significant difference between the non-irradiated and irradiated groups for phosphate (p = 0.011), carbonate (p < 0.001), amide III (p = 0.038), and carbonate/mineral ratio (p < 0.001). Regarding the root third, there was a difference for amide I (p = 0.002), mineral/matrix ratio (p = 0.001), and amide I/CH 2  (p = 0.026) between the cervical and the others. Raman spectroscopy revealed no difference between groups for 961/1458 cm -1  in the diffusion zone. CLSM showed a different interaction pattern for the two cements with the irradiated dentin from the cervical third.
CONCLUSIONS


Ionizing radiation altered the chemical composition of root dentin, especially in the cervical third. The resin cements showed less interaction with the irradiated root dentin.
CLINICAL RELEVANCE


As radiotherapy alters the chemical composition of root dentin, the interaction of resin cement with dentin can compromise the success of rehabilitation with fiberglass posts.",2022,"In the FTIR, there was a significant difference between the non-irradiated and irradiated groups for phosphate (p = 0.011), carbonate (p < 0.001), amide III (p = 0.038), and carbonate/mineral ratio (p < 0.001).",['Forty human premolars'],"['amide', 'CLSM', 'resin cement (n\u2009=\u200910): conventional (RelyX ARC, 3\xa0M ESPE) or self-adhesive ', 'radiotherapy']",['mineral/matrix ratio '],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0002482', 'cui_str': 'Amide'}, {'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1138232', 'cui_str': 'RelyX ARC'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.107687,"In the FTIR, there was a significant difference between the non-irradiated and irradiated groups for phosphate (p = 0.011), carbonate (p < 0.001), amide III (p = 0.038), and carbonate/mineral ratio (p < 0.001).","[{'ForeName': 'Alessandro Marcelo', 'Initials': 'AM', 'LastName': 'Pelloso', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Av Pará 1720, Block 4L, Campus Umuarama, Uberlândia, MG, 38405-320, Brazil.'}, {'ForeName': 'Rafael Resende', 'Initials': 'RR', 'LastName': 'de Miranda', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Av Pará 1720, Block 4L, Campus Umuarama, Uberlândia, MG, 38405-320, Brazil.'}, {'ForeName': 'Matheus Elias', 'Initials': 'ME', 'LastName': 'Rossi', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Av Pará 1720, Block 4L, Campus Umuarama, Uberlândia, MG, 38405-320, Brazil.'}, {'ForeName': 'Adriano Luiz Balthazar', 'Initials': 'ALB', 'LastName': 'Bianchini', 'Affiliation': 'Radiotherapy Sector, Clinical Hospital, Federal University of Triângulo Mineiro, Av Getúlio Guaritá 130, Uberaba, MG, 38025-440, Brazil.'}, {'ForeName': 'Francisco Américo Silveira', 'Initials': 'FAS', 'LastName': 'Marcelino', 'Affiliation': 'Radiotherapy Sector, Clinical Hospital, Federal University of Triângulo Mineiro, Av Getúlio Guaritá 130, Uberaba, MG, 38025-440, Brazil.'}, {'ForeName': 'Edna Lúcia Coutinho', 'Initials': 'ELC', 'LastName': 'da Silva', 'Affiliation': 'Postgraduate Program in Dentistry, School of Dentistry, CEUMA University, Rua Josué Montello 01, São Luís, MA, 65075-120, Brazil.'}, {'ForeName': 'Veridiana Resende', 'Initials': 'VR', 'LastName': 'Novais', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Av Pará 1720, Block 4L, Campus Umuarama, Uberlândia, MG, 38405-320, Brazil. veridianaresende@hotmail.com.'}]",Clinical oral investigations,['10.1007/s00784-022-04395-z']
440,35149904,Bonding performance and ultramorphology of the resin-dentine interface of contemporary universal adhesives.,"OBJECTIVES


This study aimed at evaluating the microtensile bond strength (μTBS) and the resin-dentine ultramorphology (24 h and 10 months ageing) of contemporary universal adhesives applied in self-etch (SE) or etch-and-rinse (ER) mode.
MATERIALS AND METHODS


Sixty-four sound human molars were collected and randomly allocated in 4 main experimental groups (n = 16) according to the adhesive system employed and subsequently divided into two subgroups depending on their application mode SE or ER (n = 8): ZipBond X (ZBX-SE; ZBX-ER), Prime and Bond Active (PBA-SE; PBA-ER), Clearfil Universal Bond Quick (CBQ-SE; CBQ-ER) or Scotchbond Universal (SCH-SE; SCH-ER). The specimens were cut into sticks with a cross-sectional area of approximately 0.9 mm 2  and subjected to μTBS testing at 24 h or after 10 months of ageing in artificial saliva (AS). Five representative fractured specimens from each group were analysed using field-emission scanning electron microscopy (FE-SEM). Resin-dentine slabs (Ø 0.9mm 2 ) from each experimental group were immersed in Rhodamine B and subsequently analysed using confocal microscopy analysis (CLSM). The μTBS results were analysed using a two-way ANOVA and Newman-Keuls multiple-comparison test (α = 0.05).
RESULTS


ZBX, PBA and SCH exhibited greater μTBS values than CQB at 24 h in both SE and ER modes (p < 0.05). CQB showed a significant decrease in μTBS values after ageing both when used in SE and ER mode (p < 0.05). ZBX-ER exhibited no significant differences in the μTBS test after ageing (p > 0.05), while a significant drop in μTBS was seen in SCH-ER and APB-ER after 10-month ageing (p < 0.05). Clear signs of degradation were evident in the resin-dentine interface created with CQB regardless of the application mode or the ageing time. In APB-ER and SCH-ER groups, such signs of degradation were evident after ageing in AS. ZBX showed slight dye infiltration both when used in ER and SE mode.
CONCLUSIONS


The long-term bonding performance of modern universal adhesives is usually influenced by the adhesive strategy employed; self-etching application should be prioritised during dentine bonding. Moreover, the use of shortened bonding protocols may compromise the quality of the resin-dentine interface and the bonding performance of most modern universal adhesives.
CLINICAL RELEVANCE


The use of etch-and-rinse bonding procedures, as well as ""shortened"" application protocols should be eluded when using modern universal adhesives in dentine. However, new generation universal adhesives based on innovative chemical formulations may probably allow clinicians to achieve long-term bonding performance with such simplified system also when employed in ER mode.",2022,Clear signs of degradation were evident in the resin-dentine interface created with CQB regardless of the application mode or the ageing time.,['Sixty-four sound human molars were collected and randomly allocated in 4 main experimental groups (n\u2009=\u200916) according to the adhesive system employed and subsequently divided into two subgroups depending on their application mode SE or ER (n\u2009=\u20098'],"['resin-dentine ultramorphology', 'ZBX', 'ZipBond X (ZBX-SE; ZBX-ER', 'Resin-dentine slabs', 'CQB']","['μTBS test', 'μTBS', 'microtensile bond strength (μTBS', 'μTBS values']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",64.0,0.0704401,Clear signs of degradation were evident in the resin-dentine interface created with CQB regardless of the application mode or the ageing time.,"[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Maciel Pires', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, Universidade Federal Do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Dávila-Sánchez', 'Affiliation': 'Departamento de Odontologia Restauradora Y Biomateriales, Universidad San Francisco de Quito USFQ, Pampite s/n y Diego de Robles, 170901, Quito, Ecuador.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Faus-Matoses', 'Affiliation': 'Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, 46010, Valencia, Spain.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Nuñez Martí', 'Affiliation': 'Dental Biomaterials and Minimally Invasive Dentistry, Department of Dentistry, Cardenal Herrera-CEU University, CEU Universities, C/Santiago Ramón Y Cajal, s/n., Alfara del Patriarca, 46115, Valencia, Spain.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lo Muzio', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Foggia, Via Rovelli 50, 71122, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Sauro', 'Affiliation': 'Dental Biomaterials and Minimally Invasive Dentistry, Department of Dentistry, Cardenal Herrera-CEU University, CEU Universities, C/Santiago Ramón Y Cajal, s/n., Alfara del Patriarca, 46115, Valencia, Spain. salvatore.sauro@uch.ceu.es.'}]",Clinical oral investigations,['10.1007/s00784-022-04402-3']
441,35551928,"Separate and combined effects of alcohol and cannabis on mood, subjective experience, cognition and psychomotor performance: A randomized trial.","Co-use of alcohol and cannabis is associated with increased frequency and intensity of use and related problems. This study examined acute effects of alcohol and cannabis on mood, subjective experience, cognition, and psychomotor performance. Twenty-eight healthy cannabis users aged 19-29 years with recent history of binge drinking completed this within-subjects, double-blind, double-dummy, placebo-controlled, randomized clinical trial. Participants received: placebo alcohol and placebo cannabis (<0.1% THC); alcohol (target breath alcohol content [BrAC] 80 mg/dL) and placebo cannabis; placebo alcohol and active cannabis (12.5% THC); and active alcohol and cannabis over four sessions. Profile of Mood States (POMS), Addiction Research Centre Inventory (ARCI), verbal free recall (VFR), Digit Symbol Substitution Test (DSST), Continuous Performance Test (CPT), and grooved pegboard (GPB) task were administered before and approximately 75 min after drinking alcohol (1 h after smoking cannabis ad libitum). Significant effects of condition were found for the POMS (Tension-Anxiety, Confusion) and ARCI (MBG, LSD, PCAG, Euphoria, Sedation), predominantly with greater increases emerging after cannabis or alcohol-cannabis combined relative to placebo. Significant effects were found for VFR (immediate total and delayed recall, percent retained), DSST (trials attempted, trials correct, reaction time), and GPB (non-dominant hand) predominantly with greater declines in performance after alcohol and alcohol-cannabis combined relative to placebo and/or cannabis. Cannabis appeared to affect mood and subjective experience, with minimal impact on cognitive performance. Alcohol appeared to impair cognitive and psychomotor performance, with minimal impact on mood and subjective experience. Acute effects of alcohol and cannabis combined were additive at most.",2022,"Significant effects of condition were found for the POMS (Tension-Anxiety, Confusion) and ARCI (MBG, LSD, PCAG, Euphoria, Sedation), predominantly with greater increases emerging after cannabis or alcohol-cannabis combined relative to placebo.",['Twenty-eight healthy cannabis users aged 19-29\u202fyears with recent history of binge drinking completed this within-subjects'],"['placebo', 'placebo alcohol and placebo cannabis (<0.1% THC); alcohol (target breath alcohol content [BrAC] 80\u202fmg/dL) and placebo cannabis; placebo alcohol and active cannabis (12.5% THC); and active alcohol and cannabis over four sessions', 'alcohol and cannabis']","['VFR (immediate total and delayed recall, percent retained), DSST (trials attempted, trials correct, reaction time), and GPB', 'Profile of Mood States (POMS), Addiction Research Centre Inventory (ARCI), verbal free recall (VFR), Digit Symbol Substitution Test (DSST), Continuous Performance Test (CPT), and grooved pegboard (GPB) task', 'cognitive and psychomotor performance', 'cognitive performance', 'POMS (Tension-Anxiety, Confusion) and ARCI (MBG, LSD, PCAG, Euphoria, Sedation', 'mood, subjective experience, cognition and psychomotor performance', 'mood, subjective experience, cognition, and psychomotor performance']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4517544', 'cui_str': '12.5'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",28.0,0.053851,"Significant effects of condition were found for the POMS (Tension-Anxiety, Confusion) and ARCI (MBG, LSD, PCAG, Euphoria, Sedation), predominantly with greater increases emerging after cannabis or alcohol-cannabis combined relative to placebo.","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wickens', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada. Electronic address: Christine.Wickens@camh.ca.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Mann', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada; Controlled Substances and Cannabis Directorate, Health Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Di Ciano', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Stoduto', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fares', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Matheson', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada; Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; Addictions Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Institute of Medical Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; Institute of Medical Sciences, University of Toronto, Toronto, Ontario, Canada; Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation; Klinische Psychologie & Psychotherapie, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Shuper', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Sproule', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Pharmacy Department, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andriy', 'Initials': 'A', 'LastName': 'Samohkvalov', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Addictions Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Institute of Emerging Health Professions, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada; Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; Klinische Psychologie & Psychotherapie, Technische Universität Dresden, Dresden, Germany; Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2022.110570']
442,35150143,Does nano-curcumin supplementation improve hematological indices in critically ill patients with sepsis? A randomized controlled clinical trial.,"Sepsis is the final common pathway to death for severe infectious diseases worldwide. The present trial aimed to investigate the effects of nano-curcumin supplementation on hematological indices in critically ill patients with sepsis. Fourteen ICU-admitted patients were randomly allocated into either nano-curcumin or placebo group for 10 days. The blood indices, serum levels of inflammatory biomarker and presepsin as well as nutrition status, and clinical outcomes were assessed before the intervention and on days 5 and 10. White blood cells, neutrophils, platelets, erythrocyte sedimentation rate (ESR), and the levels of interleukin-8 significantly decreased in the nano-curcumin group compared to the placebo after 10 days of intervention (p = .024, p = .045, p = .017, p = .041, and p = .004, respectively). There was also a marginal meaningful decrease in serum presepsin levels in the intervention group compared to the placebo at the end of the study (p = .054). However, total lymphocyte count showed a significant increase in the nano-curcumin group compared to the placebo at the end-point (p = .04). No significant differences were found in the level of lymphocyte and the ratios of neutrophil/lymphocyte and platelet/lymphocyte between the study groups. Moreover, no significant between-group differences were observed for other study outcomes, post-intervention. Collectively, nano-curcumin may be a useful adjuvant therapy in critically ill patients with sepsis. However, further trials are suggested to examine the effects of nano-curcumin in the management of sepsis and its complications. PRACTICAL APPLICATIONS: Curcumin (1,7-bis[4-hydroxy-3-methoxyphenyl]-1,6-heptadiene-3,5- dione) or diferuloylmethane is widely used in medicine due to its several biological properties. Recent evidence has shown that curcumin possesses multiple pharmacological activities including immune-modulatory, antioxidant, anti-inflammatory, anti-cancer, and anti-microbial effects. In this study, it was observed that nano-curcumin at a dose of 160 mg for 10 days, without side effects, reduced some inflammatory factors and regulated the immune responses in sepsis patients. For the first time, this trial was conducted to determine the effect of nano-curcumin on hematological indices and the serum levels of presepsin and IL-8.",2022,No significant differences were found in the level of lymphocyte and the ratios of neutrophil/lymphocyte and platelet/lymphocyte between the study groups.,"['Fourteen ICU-admitted patients', 'critically ill patients with sepsis']","['placebo', 'nano-curcumin', 'nano-curcumin supplementation', 'nano-curcumin or placebo', 'Curcumin (1,7-bis[4-hydroxy-3-methoxyphenyl]-1,6-heptadiene-3,5- dione) or diferuloylmethane', 'curcumin supplementation']","['blood indices, serum levels of inflammatory biomarker and presepsin as well as nutrition status, and clinical outcomes', 'White blood cells, neutrophils, platelets, erythrocyte sedimentation rate (ESR), and the levels of interleukin-8', 'total lymphocyte count', 'hematological indices and the serum levels of presepsin and IL-8', 'serum presepsin levels', 'level of lymphocyte and the ratios of neutrophil/lymphocyte and platelet/lymphocyte', 'hematological indices']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.128465,No significant differences were found in the level of lymphocyte and the ratios of neutrophil/lymphocyte and platelet/lymphocyte between the study groups.,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Naeini', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Razmi', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anatomical Sciences, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Vajdi', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pouria', 'Initials': 'P', 'LastName': 'Sefidmooye Azar', 'Affiliation': 'Department of Nutrition and Hospitality Management, School of Applied Sciences, The University of Mississippi, University Park, Mississippi, USA.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Najifipour', 'Affiliation': 'Endoceine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tarighat-Esfanjani', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Karimi', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of food biochemistry,['10.1111/jfbc.14093']
443,35149125,End-of-treatment HBcrAg and HBsAb levels identify durable functional cure after Peg-IFN-based therapy in patients with CHB.,"BACKGROUND & AIMS


Functional cure can be sustained in a proportion of patients with chronic hepatitis B (CHB) who lose hepatitis B surface antigen (HBsAg) after pegylated interferon alpha (Peg-IFN-ɑ)-based treatment. In this study, we aimed to identify biomarkers associated with a durable functional cure and to dissect potential immunological mechanisms.
METHODS


Of 257 nucleos(t)ide analogue-suppressed patients with CHB in the ANCHOR study, 80 patients randomly assigned to 96-week Peg-IFN-α-based therapy with 24-week off-treatment follow-up were included in this parallel study. Virologic and immunological biomarkers were examined dynamically. A response was defined as HBsAg loss or hepatitis B surface antibody (HBsAb) appearance at the end of treatment (EOT). Sustained response (SR) or durable functional cure was defined as sustained HBsAg loss with or without the appearance of HBsAb at the end of follow-up (EOF).
RESULTS


Thirty-six (45.0%) out of 80 patients achieved a response at EOT; 58.3% (21/36) of responders maintained SR at EOF. Quantitative hepatitis B core-related antigen (qHBcrAg) and HBsAb at EOT were associated with SR, with AUROCs of 0.697 (0.512-0.882, p = 0.047) and 0.744 (0.573-0.915, p = 0.013), respectively. A combination of HBcrAg <4 log 10 U/ml and HBsAb >2 log 10 IU/L at EOT had a positive predictive value of 100% for SR with an AUROC of 0.822 (0.684-0.961, p = 0.001). These patients showed maintained proportions of HBV envelope-specific CD8 + T and B cells, a markedly increased proportion of T follicular helper cells after Peg-IFN-ɑ discontinuation, and significantly higher proportions of HBV polymerase-specific CD8 + T and CD86 + CD19 + B cells at EOF.
CONCLUSIONS


Lower HBcrAg and higher HBsAb levels at EOT were associated with sustained cellular and humoral immune responses. They can be used to identify patients likely to achieve durable functional cure post Peg-IFN-based therapy.
CLINICALTRIALS



GOV IDENTIFIER


NCT02327416 LAY SUMMARY: Functional cure can be sustained in a proportion of patients with chronic hepatitis B after pegylated interferon alpha-based treatment. However, predicting who will achieve durable functional cure remains challenging. Herein, we show that low levels of hepatitis B core-related antigen and higher levels of hepatitis B surface antibodies at the end of treatment are linked to immunological responses and are associated with durable functional cure.",2022,"Quantitative hepatitis B core-related antigen (qHBcrAg) and HBsAb at EOT were associated with SR, with AUROCs of 0.697 (0.512-0.882, p=0.047) and 0.744 (0.573-0.915, p=0.013), respectively.","['NUC)-suppressed CHB patients in the ANCHOR study, 80 patients randomly assigned to 96-week Peg-IFN-based therapy with 24-week off-treatment follow-up were included in this parallel study', 'patients with CHB', 'chronic hepatitis B (CHB) patients who lose hepatitis B surface antigen (HBsAg) after pegylated interferon alpha (Peg-IFN-ɑ)-based treatment', 'Of 257 nucleos(t)ide analogue']",['Peg-IFN-based therapy'],"['Sustained response (SR) or durable functional cure', 'HBV envelope-specific CD8 + T and B cells', 'Quantitative hepatitis B core-related antigen (qHBcrAg) and HBsAb at EOT', 'HBV polymerase-specific CD8 + T and CD86 + CD19 + B cells at EOF', 'HBsAg loss or hepatitis B surface antibody (HBsAb) appearance', 'Virologic and immunological biomarkers', 'sustained T follicular helper and B cell immune responses', 'proportion of T follicular helper cells', 'HBsAb levels']","[{'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}]","[{'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0083910', 'cui_str': 'P protein, Hepatitis B virus'}, {'cui': 'C0527903', 'cui_str': 'Lymphocyte antigen CD86'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C1277834', 'cui_str': 'Hepatitis B surface antibody level'}]",80.0,0.0340736,"Quantitative hepatitis B core-related antigen (qHBcrAg) and HBsAb at EOT were associated with SR, with AUROCs of 0.697 (0.512-0.882, p=0.047) and 0.744 (0.573-0.915, p=0.013), respectively.","[{'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Danqing', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Junjian', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yaqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Tao', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Meifang', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'National Medical Center for Major Public Health Events, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: xpluo@tjh.tjmu.edu.cn.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: ywm_net@qq.com.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ning', 'Affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; State Key Laboratory for Zoonotic Diseases, Wuhan, China; Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: qning@vip.sina.com.'}]",Journal of hepatology,['10.1016/j.jhep.2022.01.021']
444,35149112,"Consumers' decision-making process when choosing potentially risky, frequently used chemical household products: The case of laundry detergents.","Chemical household products are a common cause of accidents in the domestic sphere. Despite such products being associated with certain risks in the event of swallowing or contact with the skin or eyes, they are used in nearly every household worldwide for hygiene purposes. In most European countries, chemical household products feature warnings of the Globally Harmonized System (GHS) as well as other warnings. In this eye-tracking study (N = 147), which was conducted in a virtual environment, we examined (i) whether consumers use such warnings when choosing a laundry detergent, (ii) whether they consider information irrelevant to risk assessment and (iii) whether they make use of this information for their final product choice. For this, the participants were split randomly into three experimental groups (a risk priming group, an effectiveness priming group, and a control group) that each received different tasks while purchasing a laundry detergent. The results indicate that the warnings found on laundry detergents are effective when they are used, although the majority of consumers do not look at the warnings. Therefore, we suggest that the alternative placement of warnings or the use of simplified warnings should be considered to improve consumers' awareness of potential risks.",2022,"In most European countries, chemical household products feature warnings of the Globally Harmonized System (GHS) as well as other warnings.",[],['control group) that each received different tasks while purchasing a laundry detergent'],[],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2960215', 'cui_str': 'Laundry detergent'}]",[],,0.0194974,"In most European countries, chemical household products feature warnings of the Globally Harmonized System (GHS) as well as other warnings.","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Buchmüller', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland. Electronic address: kim.buchmueller@hest.ethz.ch.'}, {'ForeName': 'Chengyan', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bearth', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Siegrist', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland.'}]",Environmental research,['10.1016/j.envres.2022.112894']
445,35150590,"Effect of Denture Hygiene Protocols on Patient Satisfaction, Oral Health-Related Quality of Life, and Salivary Parameters: A Randomized Clinical Trial.","PURPOSE


This randomized controlled trial compared four denture hygiene protocols in terms of patient satisfaction, oral health-related quality of life (OHRQoL), and salivary parameters in complete denture wearers with denture stomatitis.
MATERIAL AND METHODS


For this randomized, double-blind, controlled clinical trial, 108 participants were assigned to soak their dentures in one of the following solutions: (1) 0.25% sodium hypochlorite (positive control), (2) 0.15% Triclosan, (3) denture disinfecting tablets, or (4) denture disinfecting tablets plus palatine mucosa brushing solution. The outcomes of patient satisfaction, OHRQoL, and salivary parameters (salivary flow rate and pH) were measured at baseline and after 10 days. The Kruskal-Wallis and Dunn tests (between groups), and Wilcoxon test (between times) were used to compare the results. (α = 0.05).
RESULTS


After the hygiene protocols, and when compared with baseline, the overall patient satisfaction, maxillary denture satisfaction, maxillary denture comfort, and maxillary denture retention were ameliorated. A significant improvement was noted in OHRQoL in 3 of 4 domains evaluated (orofacial pain and discomfort, masticatory discomfort and disability, and psychological disability and discomfort). The salivary flow rate (unstimulated and stimulated) and salivary pH were not significantly affected at the times evaluated.
CONCLUSIONS


Complete denture wearers may feel more satisfied with their complete dentures when treated for denture stomatitis. The tested treatments lead to similar improvement in terms of patient satisfaction and OHRQoL.",2022,"A significant improvement was noted in OHRQoL in 3 of 4 domains evaluated (orofacial pain and discomfort, masticatory discomfort and disability, and psychological disability and discomfort).","['108 participants were assigned to soak their dentures in one of the following solutions: (1) 0.25', 'complete denture wearers with denture stomatitis']","['Denture Hygiene Protocols', 'sodium hypochlorite (positive control), (2) 0.15% Triclosan, (3) denture disinfecting tablets, or (4) denture disinfecting tablets plus palatine mucosa brushing solution']","['overall patient satisfaction, maxillary denture satisfaction, maxillary denture comfort, and maxillary denture retention', 'Patient Satisfaction, Oral Health-Related Quality Of Life, and Salivary Parameters', 'orofacial pain and discomfort, masticatory discomfort and disability, and psychological disability and discomfort', 'salivary flow rate', 'patient satisfaction and OHRQoL', 'patient satisfaction, OHRQoL, and salivary parameters (salivary flow rate and pH', 'OHRQoL', 'patient satisfaction, oral health-related quality of life (OHRQoL), and salivary parameters']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0038364', 'cui_str': 'Denture stomatitis'}]","[{'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011397', 'cui_str': 'Denture Retention'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}]",108.0,0.251397,"A significant improvement was noted in OHRQoL in 3 of 4 domains evaluated (orofacial pain and discomfort, masticatory discomfort and disability, and psychological disability and discomfort).","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Barbosa Ribeiro', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Borba Araújo', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Vieira Fortes', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lucarini Bueno', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'de Cássia Oliveira', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Macedo', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'de Freitas Oliveira Paranhos', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'Watanabe', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'De Wever', 'Affiliation': 'Bonyf AG, Vaduz, Liechtenstein.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Helena Silva-Lovato', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13494']
446,35031522,"Obstetrical randomized controlled trials: individuals screened, approached, and enrolled.","BACKGROUND


The use of randomized clinical trials (RCTs) is predicated on the idea that the study group is representative of the overall clinical population; however, recent studies have suggested that this may not be the case in obstetrics. 1 , 2  The generalizability of several seminal obstetrical RCTs, including the A Randomized Trial of Induction Versus Expectant Management trial, has been questioned because of the high ratio of assessed-to-enrolled individuals. 3  Although difficulty in recruitment for obstetrical RCTs is known, 4  it has been postulated that this high ratio increases the likelihood of the study population not being truly representative. Our primary objective was to analyze the assessed-to-enrolled ratio in contemporary obstetrical RCTs.
STUDY DESIGN


During a 4-year period (January 2017 to December 2020), we identified all obstetrical RCTs published in 6 journals (The New England Journal of Medicine, Journal of the American Medical Association, Lancet, American Journal of Obstetrics & Gynecology, British Journal of Obstetrics and Gynaecology, and Obstetrics & Gynecology). The journals were manually reviewed by 2 coauthors to ensure all obstetrical RCTs were identified and abstracted accurately. Reported patient recruitment data, per Consolidated Standards of Reporting Trials recommendations, 5  were abstracted from each RCT. Based on the primary outcome of the study, the purpose of the trial was categorized as preventative or treatment. Medians were compared using Wilcoxon rank-sum testing, and P<.05 was considered significant.
RESULTS


Of 240 obstetrical RCTs that were identified, 193 (80%) reported data on the number of individuals screened and recruited. The median number of individuals screened per trial was 850 (interquartile range [IQR], 323-2582), of which 348 were eligible (IQR, 201-1347) and 300 (IQR, 133-894) were randomized. There was no difference in trials based internationally or in the United States (P=.26). Compared with preventative RCTs, the trials that had treatment as the primary outcome were significantly more likely to screen a larger number of individuals for eligibility (P<.01) and subsequently randomize (P<.02). There was no difference in the median number of individuals who declined enrollment between trials with prevention or treatment as their objective (P=.12). More individuals were lost to follow-up in trials with prevention as the primary outcome (P<.01), although the median number lost was low at 3 (IQR, 0-21).
CONCLUSION


The low assessed-to-enrolled ratio found in this study suggested that researchers are casting a large net for patient recruitment. The relatively high eligible-to-randomized ratio suggested that most individuals are willing to participate in obstetrical RCTs. This finding was at odds with previous critiques of obstetrical RCTs that had called in to question study results secondary to high eligible-to-randomized ratios. Further research into how patients are recruited and counseled is indicated, to explore this variation. The ratio of patients assessed for study eligibility to patients enrolled in preventative vs treatment RCTs was not substantially different. Based on this result, patients seemed to be similarly interested in being enrolled to prevent a complication from pregnancy as in treating one. These results supported the concept that most individuals in the obstetrical RCTs represent the eligible population.",2022,"More individuals were lost to follow-up in trials with prevention as the primary outcome (P<.01), although the median number lost was low at 3 (IQR, 0-21).
","['median number of individuals screened per trial was 850 (interquartile range [IQR], 323-2582), of which 348 were eligible (IQR, 201-1347) and 300 (IQR, 133-894) were randomized']",[],['median number lost'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517563', 'cui_str': '133'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",5.0,0.423183,"More individuals were lost to follow-up in trials with prevention as the primary outcome (P<.01), although the median number lost was low at 3 (IQR, 0-21).
","[{'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Ditter', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Ellen H', 'Initials': 'EH', 'LastName': 'Crowe', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Mendez-Figueroa', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Michal Fishel', 'Initials': 'MF', 'LastName': 'Bartal', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School, Brown University, 101 Dudley St., Providence, RI 02905. Electronic address: stephen_wagner@brown.edu.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100564']
447,35151021,Evaluating the efficacy of common humanity-enhanced exposure for socially anxious young adults.,"Despite some evidence of the benefits of self-compassion training among socially anxious individuals, little is known about whether enhancing self-compassion prior to exposure therapy increases initial exposure engagement. Additionally, manipulations have relied on broad definitions of self-compassion, rendering it difficult to distinguish the impact of individual components. This study employed three experiential exercises designed to enhance one facet of self-compassion-common humanity. Socially anxious undergraduates (N = 63) were randomized in groups to 1) common humanity-enhanced exposure (n = 32) or 2) exposure alone (n = 31). In the common humanity condition, participants wrote self-compassionately, shared fears, and completed a common humanity-focused lovingkindness meditation. All participants then completed a speech exposure in front of live judges followed by an optional second exposure. Within the common humanity condition, positive self-responding to the speech exposure increased (b = 0.30, p = .026). Common humanity participants also remained in the first exposure longer, relative to exposure alone (b = -30.92, p = .002). Participants rated exercises as at least moderately helpful, with sharing fears rated most helpful. In sum, a brief group-based multi-modal common humanity induction represents a promising approach to improving initial engagement with feared contexts among socially anxious individuals.",2022,"Common humanity participants also remained in the first exposure longer, relative to exposure alone (b = -30.92, p = .002).","['socially anxious individuals', 'Socially anxious undergraduates (N\xa0=\xa063', 'socially anxious young adults']","['common humanity-enhanced exposure', 'humanity-enhanced exposure (n\xa0=\xa032) or 2) exposure alone']",['positive self-responding to the speech exposure'],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0020157', 'cui_str': 'Humanities'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",63.0,0.101043,"Common humanity participants also remained in the first exposure longer, relative to exposure alone (b = -30.92, p = .002).","[{'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Slivjak', 'Affiliation': 'University of Colorado Boulder, Department of Psychology and Neuroscience, Boulder, CO, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Pedersen', 'Affiliation': 'University of Colorado Boulder, Department of Psychology and Neuroscience, Boulder, CO, USA.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Arch', 'Affiliation': 'University of Colorado Boulder, Department of Psychology and Neuroscience, Boulder, CO, USA. Electronic address: Joanna.Arch@Colorado.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2022.102542']
448,35151711,Comparison of 22-gauge standard and Franseen needles in EUS-guided tissue acquisition for diagnosing solid pancreatic lesions: a multicenter randomized controlled trial.,"BACKGROUND AND AIMS


This large multicenter randomized controlled trial compared the diagnostic yields of 22-gauge standard and 22-gauge Franseen needles for EUS-guided tissue acquisition (EUS-TA) of solid pancreatic lesions.
METHODS


Consecutive patients with solid pancreatic lesions were prospectively randomized to EUS-TA using standard or Franseen needles. Samples obtained with the first needle pass and with second and subsequent passes were evaluated separately. The primary endpoint was the rate of accuracy for diagnosis of malignancy. Other endpoints were technical success rate, sample cellularity, adverse events, diagnostic accuracy in patient subgroups, and the diagnostic accuracy and numbers of second and subsequent needle passes.
RESULTS


Of 523 patients undergoing EUS-TA, 260 were randomized to using standard 22-gauge needles and 263 to 22-gauge Franseen needles. The technical success rate in each group was 99.6%, with similar adverse event rates in the standard (1.5%) and Franseen (.8%) needle groups. First-pass EUS-TA using the Franseen needle resulted in significantly greater diagnostic accuracy (84.0% vs 71.2%, P < .001) and sensitivity (82.4% vs 66.7%, P < .001) than first-pass EUS-TA using a standard needle and also resulted in superior diagnostic accuracy in patients requiring immunostaining. Second and subsequent EUS-TA using Franseen needles showed significantly greater accuracy (94.7% vs 90.0%, P = .049) and sensitivity (94.0% vs 88.6%, P = .047) and required fewer needle passes (1.81 vs 2.03, P = .008) than using standard needles.
CONCLUSIONS


EUS-TA with the Franseen needle is superior to EUS-TA with a standard needle with respect to diagnostic accuracy per pass, particularly in patients who require immunostaining, and number of passes when using macroscopic on-site evaluation. (Clinical trial registration numbers: UMIN000030634 and jRCTs052180062.).",2022,"First-pass EUS-TA using the Franseen needle resulted in significantly greater diagnostic accuracy (84.0% vs. 71.2%; P<0.001) and sensitivity (82.4% vs. 66.7%; P<0.001) than first-pass EUS-TA using a standard needle, and also resulted in superior diagnostic accuracy in patients requiring immunostaining.","['Consecutive patients with solid pancreatic lesions', 'Diagnosing Solid Pancreatic Lesions', '523 patients', 'patients requiring immunostaining']","['22G Standard and Franseen Needles', 'Endoscopic Ultrasound-Guided Tissue Acquisition', '22G standard and 22G Franseen needles for endoscopic ultrasound-guided tissue acquisition (EUS-TA', 'EUS-TA using standard or Franseen needles', 'EUS-TA using standard 22G needles (n=260) or 22G Franseen needles']","['superior diagnostic accuracy', 'rate of accuracy for diagnosis of malignancy', 'sensitivity', 'accuracy', 'technical success rate', 'needle passes', 'technical success rate, sample cellularity, adverse events, diagnostic accuracy in patient subgroups, and the diagnostic accuracy and numbers of second and subsequent needle passes', 'diagnostic accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",523.0,0.0612328,"First-pass EUS-TA using the Franseen needle resulted in significantly greater diagnostic accuracy (84.0% vs. 71.2%; P<0.001) and sensitivity (82.4% vs. 66.7%; P<0.001) than first-pass EUS-TA using a standard needle, and also resulted in superior diagnostic accuracy in patients requiring immunostaining.","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Itonaga', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Yasukawa', 'Affiliation': 'Department of Pathology, Kyoto Second Red Cross Hospital, Kyoto, Japan Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Nobuyasu', 'Initials': 'N', 'LastName': 'Fukutake', 'Affiliation': 'Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ogura', 'Affiliation': 'The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Asada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Japanese Red Cross Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Inatomi', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Digestive Disease Center, Department of Gastroenterology & Hepatology, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Shiomi', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Nebiki', 'Affiliation': 'Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Azumi', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan.'}, {'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Gastroenterology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Asai', 'Affiliation': 'Department of Gastroenterology, Tane General Hospital, Osaka, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Shimatani', 'Affiliation': 'Division of Gastroenterology and Hepatology, The Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Sanuki', 'Affiliation': 'Department of Gastroenterology, Kita-harima Medical Center, Hyogo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kurita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Takenaka', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Motoyuki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterology, Nara Prefecture Western Medical Center, Nara, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Hoki', 'Affiliation': 'Department of Gastroenterology, Bellland General Hospital, Sakai, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yasuda', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hisakazu', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Japanese Red Cross Society of Wakayama Medical Center, Wakayama, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Yanagisawa', 'Affiliation': 'Department of Pathology, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kitano', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2022.02.005']
449,35247378,Efficacy and safety comparison of scissor-type knives with needle-type knives for colorectal endoscopic submucosal dissection: a post-hoc propensity score-matched analysis (with videos).,"BACKGROUND AND AIMS


Many knives have been developed to improve the efficacy and safety of endoscopic submucosal dissection (ESD). We aimed to evaluate the efficacy and safety of scissor-type knives for colorectal ESD compared with needle-type knives.
METHODS


We performed a post-hoc propensity score-matched analysis in an 11-facility study between August 2013 and December 2018. A total of 2330 patients (2498 lesions) who underwent colorectal ESD were divided into needle-type (1923 patients, 2067 lesions) and scissor-type (407 patients, 431 lesions) knife groups. Short-term outcomes were compared between the 2 groups.
RESULTS


Two-to-one propensity score-matched analysis identified 814 (709 patients) and 407 (386 patients) lesions in the needle- and scissor-type knife groups, respectively. The median resection speed was significantly faster in the needle-type group (18.3 mm 2 /min) than in the scissor-type group (13.2 mm 2 /min, P < .0001), whereas en-bloc and histologic complete resection rates were not significantly different between the needle- and scissor-type groups (96.8% [788/814] vs 98.3% [400/407], P = .1888 and 95.1% [774/814] vs 95.6% [389/407], P = .7763, respectively). The rate of lesions resected using a single knife was significantly higher in the scissor-type group (98.5% [401/407]) than in the needle-type group (43.9% [357/814], P < .0001). Rates of intraoperative perforation and delayed bleeding were significantly lower in the scissor-type group than in the needle-type group (.7% [3/407] vs 2.5% [20/814], P = .0431 for each).
CONCLUSIONS


Scissor-type knives are safer for colorectal ESD. However, they are associated with slower resection speeds compared with needle-type knives. (Clinical trial registration number: UMIN000016197.).",2022,"Rates of intraoperative perforation and delayed bleeding were significantly lower in the scissor-type group than in the needle-type group (.7% [3/407] vs 2.5% [20/814], P = .0431","['2330 patients (2498 lesions) who underwent colorectal ESD were divided into needle-type (1923 patients, 2067 lesions) and scissor-type (407 patients, 431 lesions) knife groups', 'colorectal endoscopic submucosal dissection', 'Two-to-one propensity score-matched analysis identified 814 (709 patients) and 407 (386 patients) lesions in the needle- and scissor-type knife groups, respectively']",['scissor-type knives with needle-type knives'],"['en-bloc and histologic complete resection rates', 'median resection speed', 'efficacy and safety', 'rate of lesions resected using a single knife', 'Rates of intraoperative perforation and delayed bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}]",2330.0,0.0590024,"Rates of intraoperative perforation and delayed bleeding were significantly lower in the scissor-type group than in the needle-type group (.7% [3/407] vs 2.5% [20/814], P = .0431","[{'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kuwai', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Oka', 'Affiliation': 'Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kamigaichi', 'Affiliation': 'Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yuzuru', 'Initials': 'Y', 'LastName': 'Tamaru', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nagata', 'Affiliation': 'Department of Gastroenterology, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kunihiro', 'Affiliation': 'Department of Internal Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Hiraga', 'Affiliation': 'Department of Endoscopy, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Furudoi', 'Affiliation': 'Department of Gastroenterology, JA Hiroshima General Hospital, Hatsukaichi, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Onogawa', 'Affiliation': 'Department of Gastroenterology, Onomichi General Hospital, Onomichi, Japan.'}, {'ForeName': 'Hideharu', 'Initials': 'H', 'LastName': 'Okanobu', 'Affiliation': 'Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Mizumoto', 'Affiliation': 'Department of Gastroenterology, Miyoshi Central Hospital, Miyoshi, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Miwata', 'Affiliation': 'Department of Gastroenterology, Chugoku Rosai Hospital, Kure, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Okamoto', 'Affiliation': 'Department of Gastroenterology, Kure Kyosai Hospital, Kure, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2022.02.042']
450,35157371,Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval.,"JOURNAL CLUB


Furie R, Khamashta M, Merrill JT, Werth VP, Kalunian K, Brohawn P, et al. Anifrolumab, an anti-interferon-α receptor monoclonal antibody, in moderate-to-severe systemic lupus erythematosus. Arthritis Rheumatol 2017;69:376-86. Objective To assess the efficacy and safety of anifrolumab, a type I interferon (IFN) receptor antagonist, in a phase IIb, randomized, double-blind, placebo-controlled study of adults with moderate-to-severe systemic lupus erythematosus (SLE). Methods Patients (n = 305) were randomized to receive intravenous anifrolumab (300 mg or 1,000 mg) or placebo, in addition to standard therapy, every 4 weeks for 48 weeks. Randomization was stratified by SLE Disease Activity Index 2000 score (<10 or ≥10), oral corticosteroid dosage (<10 or ≥10 mg/day), and type I IFN gene signature test status (high or low) based on a 4-gene expression assay. The primary end point was the percentage of patients achieving an SLE Responder Index (SRI [4]) response at week 24 with sustained reduction of oral corticosteroids (<10 mg/day and less than or equal to the dose at week 1 from week 12 through 24). Other end points (including SRI [4], British Isles Lupus Assessment Group [BILAG]-based Composite Lupus Assessment [BICLA], modified SRI [6], and major clinical response) were assessed at week 52. The primary end point was analyzed in the modified intent-to-treat (ITT) population and type I IFN-high subpopulation. The study result was considered positive if the primary end point was met in either of the 2 study populations. The Type I error rate was controlled at 0.10 (2-sided), within each of the 2 study populations for the primary end point analysis. Results The primary end point was met by more patients treated with anifrolumab (34.3% of 99 for 300 mg and 28.8% of 104 for 1,000 mg) than placebo (17.6% of 102) (P = 0.014 for 300 mg and P = 0.063 for 1,000 mg, versus placebo), with greater effect size in patients with a high IFN signature at baseline (13.2% in placebo-treated patients versus 36.0% [P = 0.004] and 28.2% [P = 0.029]) in patients treated with anifrolumab 300 mg and 1,000 mg, respectively. At week 52, patients treated with anifrolumab achieved greater responses in SRI(4) (40.2% versus 62.6% [P < 0.001] and 53.8% [P = 0.043] with placebo, anifrolumab 300 mg, and anifrolumab 1,000 mg, respectively), BICLA (25.7% versus 53.5% [P < 0.001] and 41.2% [P = 0.018], respectively), modified SRI(6) (28.4% versus 49.5% [P = 0.002] and 44.7% [P = 0.015], respectively), major clinical response (BILAG 2004 C or better in all organ domains from week 24 through week 52) (6.9% versus 19.2% [P = 0.012] and 17.3% [P = 0.025], respectively), and several other global and organ-specific end points. Herpes zoster was more frequent in the anifrolumab-treated patients (2.0% with placebo treatment versus 5.1% and 9.5% with anifrolumab 300 mg and 1,000 mg, respectively), as were cases reported as influenza (2.0% versus 6.1% and 7.6%, respectively), in the anifrolumab treatment groups. Incidence of serious adverse events was similar between groups (18.8% versus 16.2% and 17.1%, respectively). Conclusion Anifrolumab substantially reduced disease activity compared with placebo across multiple clinical end points in the patients with moderate-to-severe SLE. https://onlinelibrary.wiley.com/doi/10.1002/art.39962 Furie RA, Morand EF, Bruce IN, Manzi S, Kalunian KC, Vital EM, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol 2019;1:E208-19. Background Type I interferons are involved in systemic lupus erythematosus (SLE) pathogenesis. In a phase 2 trial, anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1, suppressed interferon gene signatures and substantially reduced SLE disease activity. Here, we sought to confirm the efficacy of anifrolumab versus placebo in a phase 3 trial of adult patients with SLE and moderate-to-severe disease activity despite standard-of-care treatment. Methods TULIP-1 was a double-blind, randomised, controlled, phase 3 trial done at 123 sites in 18 countries. Included patients were aged 18-70 years, with moderate-to-severe SLE, and ongoing stable treatment with either prednisone or equivalent, an antimalarial, azathioprine, mizoribine, mycophenolate mofetil or mycophenolic acid, or methotrexate. Patients were randomly assigned (2:1:2) to receive placebo, anifrolumab 150 mg, or anifrolumab 300 mg intravenously every 4 weeks for 48 weeks. Stable standard-of-care treatment continued except for mandatory attempts at oral corticosteroid tapering for patients receiving prednisone or equivalent of 10 mg/day or more at baseline. The primary outcome was the difference between the proportion of patients who achieved an SLE responder index-4 (SRI-4) response at week 52 with anifrolumab 300 mg versus with placebo. Key secondary outcomes were the difference between the anifrolumab 300 mg group and the placebo group in: proportion of patients in the interferon gene signature test-high subgroup who achieved SRI-4 at week 52; proportion of patients on 10 mg/day or more corticosteroids at baseline who achieved a sustained dose reduction to 7·5 mg/day or less from week 40 to 52; proportion of patients with a cutaneous lupus erythematosus disease area and severity index (CLASI) activity score of 10 or higher at baseline who achieved a 50% or more reduction in CLASI score by week 12; proportion of patients who achieved SRI-4 at week 24; and annualised flare rate through week 52. Other measures of disease activity were also assessed at week 52, including the British Isles Lupus Assessment Group-based composite lupus assessment (BICLA). Safety was also assessed. Efficacy and safety analyses were done in the population of patients who received at least one dose of study drug. This trial was registered at ClinicalTrials.gov (NCT02446912). Findings Between June 9, 2015, and June 16, 2017, 457 patients were randomly assigned to the anifrolumab 300 mg group (n = 180), the anifrolumab 150 mg group (n = 93), or the placebo group (n = 184). The proportion of patients at week 52 with an SRI-4 response was similar between anifrolumab 300 mg (65 [36%] of 180) and placebo (74 [40%] of 184; difference - 4·2 [95% CI -14·2 to 5·8], p = 0·41). Similarly, proportions of patients with an SRI-4 response at week 24, and at week 52 in patients in the interferon gene signature test-high subgroup, did not differ between the anifrolumab and placebo groups. In patients with baseline oral corticosteroids of at least 10 mg/day, sustained dose reduction to 7·5 mg/day or less was achieved by 42 (41%) of 103 patients in the anifrolumab 300 mg group and 33 (32%) of 102 patients in the placebo group (difference 8·9 [95% CI -4·1 to 21·9]). In patients with CLASI activity score of at least 10 at baseline, at least 50% reduction by week 12 was achieved by 24 (42%) of 58 patients in the anifrolumab 300 mg group and 14 (25%) of 54 in the placebo group (difference 17·0 [95% CI -0·3 to 34·3]). Annualised flare rates were 0·60 for anifrolumab and 0·72 for placebo (rate ratio 0·83 [95% CI 0·60 to 1·14]). BICLA response was achieved by 67 (37%) of 180 patients receiving anifrolumab 300 mg versus 49 (27%) of 184 receiving placebo (difference 10·1 [95% CI 0·6 to 19·7]). Anifrolumab's safety profile was similar to that observed in phase 2, with similar proportions of patients having a serious adverse event between groups (25 [14%] of 180 for anifrolumab 300 mg, ten [11%] of 93 for anifrolumab 150 mg, and 30 [16%] of 184 for placebo). Interpretation The primary endpoint was not reached. However, several secondary endpoints, including reduction in oral corticosteroid dose, CLASI responses, and BICLA responses, suggest clinical benefit of anifrolumab compared with placebo. Conclusive evidence for the efficacy of anifrolumab awaits further phase 3 trial data. Despite the inherent limitations of a 1-year phase 3 study, such as incomplete knowledge of applicability to the general population and scarce detection of rare safety signals, in addition to complications from prespecified restricted medication rules, our results suggest that anifrolumab might have the potential to provide a treatment option for patients who have active SLE while receiving standard therapy. Funding AstraZeneca. https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30076-1/fulltext Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, et al. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med 2020;382:211-21. Background Anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1 investigated for the treatment of systemic lupus erythematosus (SLE), did not have a significant effect on the primary end point in a previous phase 3 trial. The current phase 3 trial used a secondary end point from that trial as the primary end point. Methods We randomly assigned patients in a 1:1 ratio to receive intravenous anifrolumab (300 mg) or placebo every 4 weeks for 48 weeks. The primary end point of this trial was a response at week 52 defined with the use of the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA). A BICLA response requires reduction in any moderate-to-severe baseline disease activity and no worsening in any of nine organ systems in the BILAG index, no worsening on the Systemic Lupus Erythematosus Disease Activity Index, no increase of 0.3 points or more in the score on the Physician Global Assessment of disease activity (on a scale from 0 [no disease activity] to 3 [severe disease]), no discontinuation of the trial intervention, and no use of medications restricted by the protocol. Secondary end points included a BICLA response in patients with a high interferon gene signature at baseline; reductions in the glucocorticoid dose, in the severity of skin disease, and in counts of swollen and tender joints; and the annualized flare rate. Results A total of 362 patients received the randomized intervention: 180 received anifrolumab and 182 received placebo. The percentage of patients who had a BICLA response was 47.8% in the anifrolumab group and 31.5% in the placebo group (difference, 16.3 percentage points; 95% confidence interval, 6.3 to 26.3; P = 0.001). Among patients with a high interferon gene signature, the percentage with a response was 48.0% in the anifrolumab group and 30.7% in the placebo group; among patients with a low interferon gene signature, the percentage was 46.7% and 35.5%, respectively. Secondary end points with respect to the glucocorticoid dose and the severity of skin disease, but not counts of swollen and tender joints and the annualized flare rate, also showed a significant benefit with anifrolumab. Herpes zoster and bronchitis occurred in 7.2% and 12.2% of the patients, respectively, who received anifrolumab. There was one death from pneumonia in the anifrolumab group. Conclusions Monthly administration of anifrolumab resulted in a higher percentage of patients with a response (as defined by a composite end point) at week 52 than did placebo, in contrast to the findings of a similar phase 3 trial involving patients with SLE that had a different primary end point. The frequency of herpes zoster was higher with anifrolumab than with placebo. (Funded by AstraZeneca; ClinicalTrials.gov number, NCT02446899.) https://www.nejm.org/doi/full/10.1056/nejmoa1912196.",2022,Annualised flare rates were 0·60 for anifrolumab and 0·72 for placebo (rate ratio 0·83,"['adult patients with SLE and moderate-to-severe disease activity despite standard-of-care treatment', 'Lupus with Anifrolumab', 'population of patients who received at least one dose of study drug', 'Findings Between June 9, 2015, and June 16, 2017, 457 patients', '17·0', '123 sites in 18 countries', 'adults with moderate-to-severe systemic lupus erythematosus (SLE', '305', 'active systemic lupus erythematosus', 'Included patients were aged 18-70\u2009years, with moderate-to-severe SLE, and ongoing stable treatment with either', 'Methods Patients (n\xa0', 'patients with moderate-to-severe SLE', 'active systemic lupus erythematosus (TULIP-1', 'patients who have active SLE while receiving standard therapy', '362 patients']","['placebo', ' Type', 'anifrolumab and 182 received placebo', 'anifrolumab versus placebo', 'prednisone', 'intravenous anifrolumab', 'Anifrolumab, an anti-interferon-α receptor monoclonal antibody', 'anifrolumab', 'oral corticosteroids', 'placebo, anifrolumab 150 mg, or anifrolumab', 'Interferon Inhibition', 'anifrolumab 150 mg group', 'anifrolumab 300 mg group', 'prednisone or equivalent, an antimalarial, azathioprine, mizoribine, mycophenolate mofetil or mycophenolic acid, or methotrexate', 'anifrolumab, a type I interferon (IFN) receptor antagonist', 'interferon inhibitor anifrolumab', 'anifrolumab 300 mg versus with placebo']","['Efficacy and safety analyses', 'British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA', 'Herpes zoster', 'CLASI activity score', 'modified intent-to-treat (ITT) population and type I IFN-high subpopulation', 'Annualised flare rates', 'SRI-4 response', 'CLASI score', 'BICLA', 'reduction in oral corticosteroid dose, CLASI responses, and BICLA responses', 'modified SRI(6', 'Herpes zoster and bronchitis', 'British Isles Lupus Assessment Group [BILAG]-based Composite Lupus Assessment [BICLA], modified SRI [6], and major clinical response', 'Incidence of serious adverse events', 'disease activity', 'severity of skin disease, and in counts of swollen and tender joints', 'BICLA response', 'annualised flare rate', 'https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30076-1/fulltext Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD', 'death from pneumonia', 'greater responses in SRI(4', 'SLE disease activity', 'cutaneous lupus erythematosus disease area and severity index (CLASI) activity score', 'glucocorticoid dose and the severity of skin disease', 'percentage of patients achieving an SLE Responder Index (SRI [4]) response', 'frequency of herpes zoster', 'major clinical response', 'efficacy and safety', 'Safety', 'annualized flare rate', ' proportion of patients in the interferon gene signature test-high subgroup who achieved SRI-4', 'proportion of patients who achieved an SLE responder index-4', 'counts of swollen and tender joints and the annualized flare rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C4519739', 'cui_str': 'anifrolumab'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0331680', 'cui_str': 'Tulipa'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4519739', 'cui_str': 'anifrolumab'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0128608', 'cui_str': 'Mizoribine'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0254653', 'cui_str': 'Interferon alpha-beta Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0024137', 'cui_str': 'Cutaneous lupus erythematosus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021743', 'cui_str': 'Interferons Type I'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0006309', 'cui_str': 'Brucellosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",457.0,0.64339,Annualised flare rates were 0·60 for anifrolumab and 0·72 for placebo (rate ratio 0·83,"[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Loncharich', 'Affiliation': 'Walter Reed National Military Medical Center and National Human Genome Research Institute, Bethesda, Maryland.'}, {'ForeName': 'Caleb W', 'Initials': 'CW', 'LastName': 'Anderson', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, Maryland.'}]",ACR open rheumatology,['10.1002/acr2.11414']
451,35164485,Effect of opioid-free anesthesia on postoperative analgesia after laparoscopic gynecologic surgery.,"BACKGROUND


We performed this randomized controlled trial to evaluate the effect of opioid-free anesthesia (OFA) on postoperative analgesia after laparoscopic gynecologic surgery.
METHODS


Seventy-eight patients undergoing laparoscopic gynecologic surgery were randomized to receive either OFA (group OF) or opioid-inclusive anesthesia (group C). Postoperative sufentanil consumption within the first 24 h, Visual Analogue Scale (VAS) for pain, postoperative equivalent milligrams of morphine (EMM), severity of postoperative nausea (PN) and vomiting (PV), prevalence of postoperative nausea and vomiting (PONV), use of antiemetics, time to first passage of flatus were compared by a two-tailed Student's t-test, Wilcoxon rank-sum tests or Fisher's exact tests. Repeated measures ANOVA was used to assess the effect of allocation of groups over time.
RESULTS


The median [IQR] sufentanil consumption within 24 h was lower in group OF (4[4.5]) than in group C (6[8], mean difference [MD]=-2, 95% confidence interval [CI] [-4 to 0], P=0.029). The VAS scores at rest and during coughing at 6 h (P=0.009 at rest; P=0.002 during coughing), VAS scores during coughing at 2 h (P=0.013) and 4 h (P=0.008), EMM (P=0.026), severities of PN (P=0.003) and PV (P=0.003), and the mean time to first passage of flatus (P=0.017) was significantly less in group OF than that in group C. The prevalence of PONV (26.3% [group OF], 68.4% [group C], OR=0.31, 95% CI [0.158 to 0.589], P<0.001), use of antiemetics (5.3% [group OF], 28.9% [group C], OR=0.136, 95% CI [0.028 to 0.667], P=0.012) was also significantly different between groups.
CONCLUSIONS


Compared to opioid-inclusive anesthesia during laparoscopic gynecologic surgery, OFA was associated with significant improvement in postoperative analgesia, reduced PONV incidence prevalence and severity, and faster first passage of flatus.",2022,"Compared to opioid-inclusive anesthesia during laparoscopic gynecologic surgery, OFA was associated with significant improvement in postoperative analgesia, reduced PONV incidenceprevalence and severity, and faster first passage of flatus.","['78 patients undergoing laparoscopic gynecologic surgery', 'after laparoscopic gynecologic surgery']","['OFA (Group OF) or opioid-inclusive anesthesia', 'opioid-free anesthesia', 'opioid-free anesthesia (OFA']","['mean time to first passage of flatus', 'postoperative analgesia', 'severities of PN', 'visual analogue scale (VAS) for pain, postoperative equivalent milligrams of morphine (EMM), severity of postoperative nausea (PN) and vomiting (PV), prevalence of PONV, use of antiemetics, time to first passage of flatus', 'median [IQR] sufentanil consumption', 'VAS scores', 'Postoperative sufentanil consumption', 'use of antiemetics', 'EMM', 'VAS scores during coughing', 'postoperative analgesia, reduced PONV incidenceprevalence and severity, and faster first passage of flatus', 'prevalence of PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",78.0,0.158027,"Compared to opioid-inclusive anesthesia during laparoscopic gynecologic surgery, OFA was associated with significant improvement in postoperative analgesia, reduced PONV incidenceprevalence and severity, and faster first passage of flatus.","[{'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shaoqiang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China - jjjiaojing@126.com.'}]",Minerva anestesiologica,['10.23736/S0375-9393.22.15850-5']
452,35166800,Effect of Offering Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care on Self-harm Among Adult Outpatients With Suicidal Ideation: A Randomized Clinical Trial.,"Importance


People at risk of self-harm or suicidal behavior can be accurately identified, but effective prevention will require effective scalable interventions.
Objective


To compare 2 low-intensity outreach programs with usual care for prevention of suicidal behavior among outpatients who report recent frequent suicidal thoughts.
Design, Setting, and Participants


Pragmatic randomized clinical trial including outpatients reporting frequent suicidal thoughts identified using routine Patient Health Questionnaire depression screening at 4 US integrated health systems. A total of 18 882 patients were randomized between March 2015 and September 2018, and ascertainment of outcomes continued through March 2020.
Interventions


Patients were randomized to a care management intervention (n = 6230) that included systematic outreach and care, a skills training intervention (n = 6227) that introduced 4 dialectical behavior therapy skills (mindfulness, mindfulness of current emotion, opposite action, and paced breathing), or usual care (n = 6187). Interventions, lasting up to 12 months, were delivered primarily through electronic health record online messaging and were intended to supplement ongoing mental health care.
Main Outcomes and Measures


The primary outcome was time to first nonfatal or fatal self-harm. Nonfatal self-harm was ascertained from health system records, and fatal self-harm was ascertained from state mortality data. Secondary outcomes included more severe self-harm (leading to death or hospitalization) and a broader definition of self-harm (selected injuries and poisonings not originally coded as self-harm).
Results


A total of 18 644 patients (9009 [48%] aged 45 years or older; 12 543 [67%] female; 9222 [50%] from mental health specialty clinics and the remainder from primary care) contributed at least 1 day of follow-up data and were included in analyses. Thirty-one percent of participants offered care management and 39% offered skills training actively engaged in intervention programs. A total of 540 participants had a self-harm event (including 45 deaths attributed to self-harm and 495 nonfatal self-harm events) over 18 months following randomization: 172 (3.27%) in care management, 206 (3.92%) in skills training, and 162 (3.27%) in usual care. Risk of fatal or nonfatal self-harm over 18 months did not differ significantly between the care management and usual care groups (hazard ratio [HR], 1.07; 97.5% CI, 0.84-1.37) but was significantly higher in the skills training group than in usual care (HR, 1.29; 97.5% CI, 1.02-1.64). For severe self-harm, care management vs usual care had an HR of 1.03 (97.5% CI, 0.71-1.51); skills training vs usual care had an HR of 1.34 (97.5% CI, 0.94-1.91). For the broader self-harm definition, care management vs usual care had an HR of 1.10 (97.5% CI, 0.92-1.33); skills training vs usual care had an HR of 1.17 (97.5% CI, 0.97-1.41).
Conclusions and Relevance


Among adult outpatients with frequent suicidal ideation, offering care management did not significantly reduce risk of self-harm, and offering brief dialectical behavior therapy skills training significantly increased risk of self-harm, compared with usual care. These findings do not support implementation of the programs tested in this study.
Trial Registration


ClinicalTrials.gov Identifier: NCT02326883.",2022,"Risk of fatal or nonfatal self-harm over 18 months did not differ significantly between the care management and usual care groups (hazard ratio [HR], 1.07; 97.5% CI, 0.84-1.37) but was significantly higher in the skills training group than in usual care (HR, 1.29; 97.5% CI, 1.02-1.64).","['540 participants had a self-harm event (including 45 deaths attributed to self-harm and 495 nonfatal self-harm events) over 18 months following randomization: 172 (3.27%) in care management, 206 (3.92%) in skills training, and 162 (3.27%) in usual care', 'outpatients reporting frequent suicidal thoughts identified using routine Patient Health Questionnaire depression screening at 4 US integrated health systems', 'Adult Outpatients With Suicidal Ideation', 'A total of 18\u202f882 patients were randomized between March 2015 and September 2018, and ascertainment of outcomes continued through March 2020', 'adult outpatients with frequent suicidal ideation', 'A total of 18\u202f644 patients (9009 [48%] aged 45 years or older; 12\u202f543 [67%] female; 9222 [50%] from mental health specialty clinics and the remainder from primary care) contributed at least 1 day of follow-up data and were included in analyses', 'outpatients who report recent frequent suicidal thoughts']","['Therapy Skills Training vs Usual Care', 'Care Management or Online Dialectical Behavior', 'electronic health record online messaging and were intended to supplement ongoing mental health care', 'care management intervention (n\u2009=\u20096230) that included systematic outreach and care, a skills training intervention (n\u2009=\u20096227) that introduced 4 dialectical behavior therapy skills (mindfulness, mindfulness of current emotion, opposite action, and paced breathing), or usual care']","['Nonfatal self-harm', 'Risk of fatal or nonfatal self-harm', 'time to first nonfatal or fatal self-harm', 'severe self-harm (leading to death or hospitalization) and a broader definition of self-harm (selected injuries and poisonings not originally coded as self-harm']","[{'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0178314', 'cui_str': 'Poisoning / injury'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}]",18882.0,0.0132786,"Risk of fatal or nonfatal self-harm over 18 months did not differ significantly between the care management and usual care groups (hazard ratio [HR], 1.07; 97.5% CI, 0.84-1.37) but was significantly higher in the skills training group than in usual care (HR, 1.29; 97.5% CI, 1.02-1.64).","[{'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Shortreed', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Rossom', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Kaiser Permanente Colorado Institute for Health Research, Denver.'}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, Portland, Oregon.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Whiteside', 'Affiliation': 'NowMattersNow.org, Seattle, Washington.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Richards', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Penfold', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Boggs', 'Affiliation': 'Kaiser Permanente Colorado Institute for Health Research, Denver.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}]",JAMA,['10.1001/jama.2022.0423']
453,35168907,Effect of Volatile Anesthetics on Myocardial Infarction After Coronary Artery Surgery: A Post Hoc Analysis of a Randomized Trial.,"OBJECTIVE


To investigate the effect of volatile anesthetics on the rates of postoperative myocardial infarction (MI) and cardiac death after coronary artery bypass graft (CABG).
DESIGN


A post hoc analysis of a randomized trial.
SETTING


Cardiac surgical operating rooms.
PARTICIPANTS


Patients undergoing elective, isolated CABG.
INTERVENTIONS


Patients were randomized to receive a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or total intravenous anesthesia (TIVA). The primary outcome was hemodynamically relevant MI (MI requiring high-dose inotropic support or prolonged intensive care unit stay) occurring within 48 hours from surgery. The secondary outcome was 1-year death due to cardiac causes.
MEASUREMENTS AND MAIN RESULTS


A total of 5,400 patients were enrolled between April 2014 and September 2017 (2,709 patients randomized to the volatile anesthetics group and 2,691 to TIVA). The mean age was 62 ± 8.4 years, and the median baseline ejection fraction was 57% (50-67), without differences between the 2 groups. Patients in the volatile group had a lower incidence of MI with hemodynamic complications both in the per-protocol (14 of 2,530 [0.6%] v 27 of 2,501 [1.1%] in the TIVA group; p = 0.038) and as-treated analyses (16 of 2,708 [0.6%] v 29 of 2,617 [1.1%] in the TIVA group; p = 0.039), but not in the intention-to-treat analysis (17 of 2,663 [0.6%] v 28 of 2,667 [1.0%] in the TIVA group; p = 0.10). Overall, deaths due to cardiac causes were lower in the volatile group (23 of 2,685 [0.9%] v 40 of 2,668 [1.5%] than in the TIVA group; p = 0.03).
CONCLUSIONS


An anesthetic regimen, including volatile agents, may be associated with a lower rate of postoperative MI with hemodynamic complication in patients undergoing CABG. Furthermore, it may reduce long-term cardiac mortality.",2022,"Overall, deaths due to cardiac causes were lower in the volatile group (23 of 2,685 [0.9%] v 40 of 2,668 [1.5%] than in the TIVA group; p = 0.03).
","['5,400 patients were enrolled between April 2014 and September 2017 (2,709 patients randomized to the', 'Patients undergoing elective, isolated CABG', 'After Coronary Artery Surgery', 'Cardiac surgical operating rooms', 'patients undergoing CABG']","['Volatile Anesthetics', 'volatile anesthetic (desflurane, isoflurane, or sevoflurane) or total intravenous anesthesia (TIVA', 'volatile anesthetics']","['hemodynamically relevant MI (MI requiring high-dose inotropic support or prolonged intensive care unit stay', 'median baseline ejection fraction', 'rates of postoperative myocardial infarction (MI) and cardiac death', 'incidence of MI with hemodynamic complications', 'deaths due to cardiac causes', 'Myocardial Infarction', '1-year death due to cardiac causes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0589368', 'cui_str': 'Postoperative myocardial infarction'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0439234', 'cui_str': 'year'}]",5400.0,0.458018,"Overall, deaths due to cardiac causes were lower in the volatile group (23 of 2,685 [0.9%] v 40 of 2,668 [1.5%] than in the TIVA group; p = 0.03).
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zangrillo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Vladimir V', 'Initials': 'VV', 'LastName': 'Lomivorotov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia; Department of Anesthesiology and Intensive Care, Novosibirsk State University, Novosibirsk, Russia.'}, {'ForeName': 'Vadim V', 'Initials': 'VV', 'LastName': 'Pasyuga', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan, Russia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Gazivoda', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Cardiovascular Institute Dedinje, Belgrade, Serbia.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Caetano', 'Initials': 'C', 'LastName': 'Nigro Neto', 'Affiliation': 'Anesthesia Section, Department of Cardiovascular Surgery, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.'}, {'ForeName': 'Valery V', 'Initials': 'VV', 'LastName': 'Likhvantsev', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia; V. Negovsky Reanimatology Research Institute, Moscow, Russia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Bradic', 'Affiliation': 'Department of Cardiovascular Anesthesiology and Intensive Care Medicine, Clinical Department of Anesthesiology, Resuscitation and Intensive Care Medicine, University Hospital Dubrava, Zagreb, Croatia; Department of Biomedical Sciences, University North, Varazdin, Croatia.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Lozovskiy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Ural Institute of Cardiology, Ekaterinburg, Russia.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Lei', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Nazar A R', 'Initials': 'NAR', 'LastName': 'Bukamal', 'Affiliation': 'Cardiothoracic ICU and Anesthesia Department, Mohammed Bin Khalifa Cardiac Center, Riffa, Bahrain.'}, {'ForeName': 'Fernanda Santos', 'Initials': 'FS', 'LastName': 'Silva', 'Affiliation': 'Department of Anaesthesiology, Hospital de Santa Maria, Lisboa, Portugal.'}, {'ForeName': 'Andrey E', 'Initials': 'AE', 'LastName': 'Bautin', 'Affiliation': 'Laboratory for Anesthesiology and Intensive Care, Almazov National Medical Research Center, Saint Petersburg, Russia.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Center for Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chow Yen', 'Initials': 'CY', 'LastName': 'Yong', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Hospital Pulau Pinang, Pulau Pinang, Malaysia.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Carollo', 'Affiliation': 'Institute of Anesthesia and Intensive Care, Padua University Hospital, Padua, Italy.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kunstyr', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Faculty of Medicine Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Chew Yin', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Grigoryev', 'Affiliation': 'Intensive Care Unit, Scientific Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia.'}, {'ForeName': 'Hynek', 'Initials': 'H', 'LastName': 'Riha', 'Affiliation': 'Cardiothoracic Anesthesiology and Intensive Care Medicine, Department of Anesthesiology and Intensive Care Medicine, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Chengbin', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Center for Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mohamed R', 'Initials': 'MR', 'LastName': 'El-Tahan', 'Affiliation': 'Department of Anesthesiology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Anna Mara', 'Initials': 'AM', 'LastName': 'Scandroglio', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marzida', 'Initials': 'M', 'LastName': 'Mansor', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Lembo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Dmitry N', 'Initials': 'DN', 'LastName': 'Ponomarev', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Francisco José Lucena', 'Initials': 'FJL', 'LastName': 'Bezerra', 'Affiliation': 'Anesthesia Section, Department of Cardiovascular Surgery, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ruggeri', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Chernyavskiy', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Junmei', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Dmitry G', 'Initials': 'DG', 'LastName': 'Tarasov', 'Affiliation': 'Department of Cardiac Surgery, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan, Russian Federation.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Navalesi', 'Affiliation': 'Institute of Anesthesia and Intensive Care, Padua University Hospital, Padua, Italy; Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Yavorovskiy', 'Affiliation': 'Federal Research and Clinical Center of Resuscitation and Rehabilitation, Moscow, Russia.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Bove', 'Affiliation': 'Department of Medicine (DAME), University of Udine, Udine, Italy; Department of Anesthesia and Intensive Care Medicine, ASUFC University-Hospital of Central Friuli, Udine, Italy.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Kuzovlev', 'Affiliation': 'V. Negovsky Reanimatology Research Institute, Moscow, Russia.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Department of Cardiopneumology, Instituto do Coração, Universidade de São Paulo, São Paulo, Brazil; Intensive Care Unit, Hospital SirioLibanes, São Paulo, Brazil.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy. Electronic address: landoni.giovanni@hsr.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2022.01.001']
454,35170058,Do early responders and treatment non-responders offer guidance to make CPT group a more effective treatment?,"BACKGROUND


Treatment dropout has been problematic with evidence-based treatments for posttraumatic stress disorder (PTSD), including cognitive processing therapy (CPT). This study sought to evaluate whether CPT group contributed to symptom improvement among treatment completers and non-completers.
METHODS


Sixty-one Iraq and Afghanistan combat Veterans self-selected CPT group or treatment as usual (TAU) forming a convenience sample. Defining treatment completion as attending at least nine sessions: 18 completed treatment, 20 dropped-out (DOs); 20 completed TAU, 3 lost to TAU follow-up.
RESULTS


Multiple Regression revealed significant pre-post-treatment improvement, the Clinician-Administered PTSD Scale (CAPS-IV, F(5, 40.1) = 2.53, p = 0.0436). Reviewing DOs' last available PTSD Checklist-Military Version scores before leaving treatment, six achieved clinically significant improvement of >10 points; seven a clinically reliable change of 5-10 points.
CONCLUSION


These findings highlight that CPT group may be effective at reducing trauma-related symptoms among treatment completers and dropouts and point to the utility of a clinical definition of good treatment end-state.",2022,"RESULTS


Multiple Regression revealed significant pre-post-treatment improvement, the Clinician-Administered PTSD Scale (CAPS-IV, F(5, 40.1) = 2.53, p = 0.0436).","['Iraq and Afghanistan combat Veterans self-selected CPT group or treatment as usual', 'Sixty-one']","['cognitive processing therapy (CPT', 'CPT']","['Clinician-Administered PTSD\xa0Scale', 'PTSD Checklist-Military Version scores']","[{'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0350985,"RESULTS


Multiple Regression revealed significant pre-post-treatment improvement, the Clinician-Administered PTSD Scale (CAPS-IV, F(5, 40.1) = 2.53, p = 0.0436).","[{'ForeName': 'M Wright', 'Initials': 'MW', 'LastName': 'Williams', 'Affiliation': 'PTSD Clinical Team, Mental Health Care Line, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.'}, {'ForeName': 'Brooks', 'Initials': 'B', 'LastName': 'King-Casas', 'Affiliation': 'Research Service Line, Salem Veterans Affairs Medical Center, Salem, Virginia, USA.'}, {'ForeName': 'Pearl H', 'Initials': 'PH', 'LastName': 'Chiu', 'Affiliation': 'Research Service Line, Salem Veterans Affairs Medical Center, Salem, Virginia, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sciarrino', 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Estey', 'Affiliation': 'Menninger Clinic, Houston, Texas, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'PTSD Clinical Team, Mental Health Care Line, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'McCurry', 'Affiliation': 'Research Service Line, Salem Veterans Affairs Medical Center, Salem, Virginia, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Graham', 'Affiliation': 'PTSD Clinical Team, Mental Health Care Line, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.'}]",Journal of clinical psychology,['10.1002/jclp.23307']
455,35172176,Response to Letter to the Editor: Effectiveness of a Functional Rehabilitation Program for Upper Limb Apraxia in Poststroke Patients: A Randomized Controlled Trial.,,2022,,['upper limb apraxia in poststroke patients'],['functional rehabilitation program'],[],"[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0266285,,"[{'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA, Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada; Neurology división of San Cecilio Hospital, Granada, Spain. Electronic address: encaguilar@hotmail.com.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Toledano-Moreno', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA, Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada; Neurology división of San Cecilio Hospital, Granada, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'García-Ríos', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA, Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada; Neurology división of San Cecilio Hospital, Granada, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Tapia-Haro', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA, Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada; Neurology división of San Cecilio Hospital, Granada, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Barrero-Hernández', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA, Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada; Neurology división of San Cecilio Hospital, Granada, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Casas-Barragán', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA, Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada; Neurology división of San Cecilio Hospital, Granada, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Pérez-Mármol', 'Affiliation': 'Instituto de Investigación Biosanitaria Granada ibs.GRANADA, Department of Physical Therapy, Faculty of Health Science, University of Granada (UGR), Granada; Neurology división of San Cecilio Hospital, Granada, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2022.02.002']
456,35157497,Activity Monitoring for Toxicity Detection and Management in Patients Undergoing Chemoradiation for Gastrointestinal Malignancies.,"PURPOSE


Physical activity is associated with decreased hospitalization during cancer treatment. We hypothesize that activity data can help identify and triage high-risk patients with GI cancer undergoing concurrent chemoradiation.
MATERIALS AND METHODS


This prospective study randomly assigned patients to activity monitoring versus observation. In the intervention arm, a 20% decrease in daily steps or 20% increase in heart rate triggered triage visits to provide supportive care, medication changes, and escalation of care. In the observation group, activity data were recorded but not monitored. The primary objective was to show a 20% increase in triage visits in the intervention group. Secondary objectives were estimating the rates of emergency department (ED) visits and hospitalizations. Crude and adjusted odds ratios were computed using logistic regression modeling.
RESULTS


There were 22 patients in the intervention and 18 in the observation group. Baseline patient and treatment characteristics were similar. The primary objective was met, with 3.4 more triage visits in the intervention group than in the observation group (95% CI, 2.10 to 5.50;  P  < .0001). Twenty-six (65.0%) patients required at least one triage visit, with a higher rate in the intervention arm compared with that in the observation arm (86.4%  v  38.9%; odds ratio, 9.95; 95% CI, 2.13 to 46.56;  P  = .004). There was no statistically significant difference in ED visit (9.1%  v  22.2%;  P  = .38) or hospitalization (4.5%  v  16.7%;  P  = .31).
CONCLUSION


It is feasible to use activity data to trigger triage visits for symptom management. Further studies are investigating whether automated activity monitoring can assist with early outpatient management to decrease ED visits and hospitalizations.",2022,"There was no statistically significant difference in ED visit (9.1%  v  22.2%;  P  = .38) or hospitalization (4.5%  v  16.7%;  P  = .31).
","['Patients Undergoing Chemoradiation for Gastrointestinal Malignancies', '22 patients in the intervention and 18 in the observation group', 'risk patients with GI cancer undergoing concurrent chemoradiation']",[],"['rates of emergency department (ED) visits and hospitalizations', 'ED visit', 'triage visits', 'heart rate triggered triage visits to provide supportive care, medication changes, and escalation of care', 'activity data', 'hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]",[],"[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0469462,"There was no statistically significant difference in ED visit (9.1%  v  22.2%;  P  = .38) or hospitalization (4.5%  v  16.7%;  P  = .31).
","[{'ForeName': 'Nishant K', 'Initials': 'NK', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Amardeep', 'Initials': 'A', 'LastName': 'Grewal', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Xingmei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Ben-Josef', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Plastaras', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Metz', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Goel', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Taunk', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Shabason', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Lukens', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Berman', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Andrzej P', 'Initials': 'AP', 'LastName': 'Wojcieszynski', 'Affiliation': 'Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",JCO oncology practice,['10.1200/OP.21.00671']
457,35170247,Effectiveness of sodium bicarbonate and zinc chloride mouthwashes in the treatment of oral mucositis and quality of life in patients with cancer under chemotherapy.,"AIM


The purpose of the study is to evaluate the effectiveness of sodium bicarbonate and zinc chloride mouthwashes on oral mucositis and quality of life in patients undergoing chemotherapy.
DESIGN


The present study was a randomized controlled trial study.
METHODS


One hundred forty-four patients with a cancer diagnosis were randomly assigned into three groups: sodium bicarbonate mouthwash (n = 48), zinc chloride mouthwash (n = 48) and placebo group (n = 48). The severity of mucositis and quality of life were examined blindly at the baseline and 3-week follow-up.
RESULTS


The grade of oral mucositis decreased at the end of the third weeks in the sodium bicarbonate and zinc chloride groups rather than the placebo group (p < .001). The severity of oral mucositis in the sodium bicarbonate and zinc chloride groups decreased from end of the first week until third week (p < .001). In addition, there was significant difference in the severity of oral mucositis among the groups at the end of the second (p = .014) and the third weeks (p < .001). Also, there was a statistically significant difference in quality of life scores between the sodium bicarbonate and zinc chloride mouthwash with the placebo group (p < .001).
CONCLUSION


Zinc chloride and sodium bicarbonate mouthwashes were effective in treating and reducing the severity of oral mucositis, and subsequently improving quality of life in patients with cancer under chemotherapy. Therefore, we can recommend zinc chloride and sodium bicarbonate at the beginning of chemotherapy to improve oral health and promoting quality of life in these patients.",2022,The severity of oral mucositis in the sodium bicarbonate and zinc chloride groups decreased from end of the first week until third week (p < .001).,"['One hundred forty-four patients with a cancer diagnosis', 'patients with cancer under chemotherapy', 'patients undergoing chemotherapy']","['placebo', 'sodium bicarbonate and zinc chloride mouthwash with the placebo', 'sodium bicarbonate and zinc chloride', 'sodium bicarbonate mouthwash', 'Zinc chloride and sodium bicarbonate mouthwashes', 'sodium bicarbonate and zinc chloride mouthwashes', 'zinc chloride mouthwash', 'zinc chloride and sodium bicarbonate']","['severity of mucositis and quality of life', 'oral health and promoting quality of life', 'oral mucositis and quality of life', 'quality of life scores', 'grade of oral mucositis', 'quality of life', 'severity of oral mucositis']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0078774', 'cui_str': 'zinc chloride'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C3644722', 'cui_str': 'Sodium Bicarbonate Mouthwash'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",144.0,0.177126,The severity of oral mucositis in the sodium bicarbonate and zinc chloride groups decreased from end of the first week until third week (p < .001).,"[{'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Pediatric Nursing, Chronic Diseases (Home Care) Research Center and Autism Spectrum Disorders Research Center, Department of Nursing, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Khodayar', 'Initials': 'K', 'LastName': 'Oshvandi', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyed Ramesh', 'Initials': 'SR', 'LastName': 'Kamallan', 'Affiliation': 'Department of Medical-Surgical Nursing, Student Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Khazaei', 'Affiliation': 'Department of Epidemiology, Health Sciences Research Center, Health Sciences & Technology Research Institute, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ranjbar', 'Affiliation': 'Department of Hematology and Oncology, Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ahmadi-Motamayel', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gillespie', 'Affiliation': 'School of Health Nursing and Midwifery, University of the West of Scotland, Paisley, Scotland.'}, {'ForeName': 'Ensiyeh', 'Initials': 'E', 'LastName': 'Jenabi', 'Affiliation': 'Research Assistant Professor of Reproductive Health (By Research), Autism Spectrum disorders Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyed Yaser', 'Initials': 'SY', 'LastName': 'Vafaei', 'Affiliation': 'Department of Pharmaceutics, Department of Pharmaceutics and Pharmaceutical Biotechnology, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Nursing open,['10.1002/nop2.1168']
458,34891167,Parsing Intra- and Inter-Individual Covariation Between the Sensory Attributes and Appeal of E-Cigarettes: Associations and Gender Differences.,"INTRODUCTION


Perceived sensory attributes of e-cigarettes may associate with their appeal. However, limited studies have accounted for individuals' variability in sensory attributes or have addressed how associations of sensory attributes with appeal may differ by gender.
METHODS


Individuals (n = 119, 32.8% female) who currently used combustible cigarettes and/or e-cigarettes attended one laboratory session in which they completed a standardized e-cigarette puffing procedure according to a 10 Flavor (green apple, strawberry, chocolate, vanilla, menthol, koolada, peppermint, spearmint, subtle tobacco, and full-flavored tobacco) × 2 Nicotine Formulation (free-base, salt) double-blind factorial design. The mean nicotine concentration was 23.4 (SD = 0.9) mg/mL in the nicotine salt formulations and 23.8 (SD = 1.7) mg/mL in the free-base formulations. Following each trial, participants completed ratings of sensory attributes (sweet, smooth, cool, bitter, harsh) and appeal (mean of liking, disliking [reverse-scored], and willingness-to-use-again ratings). Sensory attributes were partitioned into between-person and within-person variables. Gender was tested as a moderator of associations of sensory attributes with appeal.
RESULTS


Sweet, smooth, and cool sensory attributes positively associated with appeal at the between- and within-person level (ps < .001). Bitter and harsh negatively associated with appeal at the between- and within-person level (ps < .001). The associations of between-person sweet, smooth, and cool ratings with appeal was larger in males compared to females. The associations of within-person smooth, bitter, and harsh with appeal was larger in females compared to males.
CONCLUSIONS


This study showed important gender differences in associations of sensory attributes and appeal.
IMPLICATIONS


While evidence suggests that sensory attributes may contribute to the appeal of e-cigarettes, there is little experimental evidence accounting for individual variability in sensory attributes and whether sensory attribute-appeal associations differ by gender. The current study provides evidence that average sweet, cool, and smooth ratings positively associated with appeal and that these associations were larger in males. Within-person bitter, harsh, and smooth ratings significantly associated with appeal in both genders, but these associations were larger in females compared to males. Data from the current report reinforces the need for researchers to study gender stratified effects in tobacco regulatory science.",2022,Bitter and harsh negatively associated with appeal at the between- and within-person level (ps<.001).,"['e-cigarettes', 'Individuals (n=119, 32.8% female) who currently used combustible cigarettes and/or e-cigarettes attended one laboratory session in which they completed a standardized e-cigarette puffing procedure according to a 10']","['Flavor (green apple, strawberry, chocolate, vanilla, menthol, koolada, peppermint, spearmint, subtle tobacco, and full-flavored tobacco']","['ratings of sensory attributes (sweet, smooth, cool, bitter, harsh) and appeal (mean of liking, disliking [reverse scored], and willingness-to-use-again ratings', 'mean nicotine concentration']","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}]","[{'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0457802', 'cui_str': 'Strawberry'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0678424', 'cui_str': 'Vanilla'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0070324', 'cui_str': 'Peppermint preparation'}, {'cui': 'C0522468', 'cui_str': 'Mentha spicata'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.149365,Bitter and harsh negatively associated with appeal at the between- and within-person level (ps<.001).,"[{'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Population and Public Health Sciences, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Mason', 'Affiliation': 'Department of Population and Public Health Sciences, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Addison K', 'Initials': 'AK', 'LastName': 'Kapsner', 'Affiliation': 'Department of Population and Public Health Sciences, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Population and Public Health Sciences, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab255']
459,35170837,Optimised minus lens overcorrection for paediatric intermittent exotropia: A randomised clinical trial.,"BACKGROUND


Aim of this study was to evaluate the efficacy of a novel algorithm to customise overminus lens therapy in intermittent exotropia (IXT) based on clinical factors associated with control of the deviation.
METHODS


Clinical parameters in IXT vary among individuals. Based on individual's physiological factors, an algorithm was developed. Children aged between 4 and 15 years with IXT were randomised into OML and observation groups. Participants in the observation group were corrected for any significant refractive error. IXT control score, angle of deviation, refraction, axial length and stereopsis were examined at baseline and follow up ranging between 6 and 15 months and compared. Compliance and tolerance to OML was determined by a symptom survey.
RESULTS


The OML power ranged between -1.00D and - 6.25D. Of the total 141 participants (mean age 6.8 ± 2.5 year), 77 were in the OML and 66 were in observation group. IXT control score improved (mean difference - 2.5 ± 1.1; p < 0.001) and angle of deviation reduced (6.9 ± 7.2pd; p < 0.001) significantly in the OML group only. Compliance rate to OML wear was 80%; 90% never or rarely experienced asthenopia symptoms. Slightly greater myopic shift (-0.36 ± 0.53D vs. -0.18 ± 0.55D) and change in axial length (0.17 vs. 0.14 mm) were observed in the OML group, but these differences were not statistically significant.
CONCLUSIONS


A customised OML, calculated using this novel algorithm was effective in improving distance control, angle of deviation and stereopsis. Glasses wear was highly tolerable.",2022,IXT control score improved (mean difference - 2.5 ± 1.1; p < 0.001) and angle of deviation reduced (6.9 ± 7.2pd; p < 0.001) significantly in the OML group only.,"['Clinical parameters in IXT vary among individuals', 'Children aged between four and fifteen years with IXT', 'paediatric intermittent exotropia']","['OML', 'novel algorithm to customise overminus lens (OML) therapy']","['Compliance rate to OML wear', 'myopic shift', 'IXT control score, angle of deviation, refraction, axial length and stereopsis', 'axial length', 'IXT control score', 'Compliance and tolerance to OML', 'angle of deviation']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",141.0,0.150225,IXT control score improved (mean difference - 2.5 ± 1.1; p < 0.001) and angle of deviation reduced (6.9 ± 7.2pd; p < 0.001) significantly in the OML group only.,"[{'ForeName': 'Jit B', 'Initials': 'JB', 'LastName': 'Ale Magar', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Shaheen P', 'Initials': 'SP', 'LastName': 'Shah', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Webber', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Sleep', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Shuan H', 'Initials': 'SH', 'LastName': 'Dai', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}]",Clinical & experimental ophthalmology,['10.1111/ceo.14060']
460,35172248,Time for a paradigm shift: The adolescent brain in addiction treatment.,"OBJECTIVE


One route to improve adolescent addiction treatment outcomes is to use translational approaches to help identify developmental neuroscience mechanisms that undergird active treatment ingredients and advance adolescent behavior change.
METHODS


This sample included 163 adolescents (ages 15-19) randomized to motivational interviewing (MI) vs. brief adolescent mindfulness (BAM). Youth completed an fMRI paradigm assessing adolescent brain response to therapist language (complex reflection vs. mindful; complex reflection vs. confront; mindful vs. confront) at pre- (prior to the completion of the full intervention) and post-treatment (at 3-month follow-up) and behavioral measures at 3, 6 and 12 months.
RESULTS


Youth in both treatment groups showed significant problem drinking reductions at 3 and 6 months, but MI youth demonstrated significantly better treatment outcomes than BAM youth at 12 months. We observed several significant treatment group differences (MI > BAM) in neural response to therapist language, including at pre-treatment when examining complex reflection vs. mindful, and complex reflection vs. confront (e.g., superior temporal gyrus, lingual gyrus); and at post-treatment when examining mindful vs. confront (e.g., supplementary motor area; middle frontal gyrus). When collapsed across treatment groups (MI + BAM), we observed significant differences by time, with youth showing a pattern of brain change in response to complex reflection vs. mindful, and complex reflection vs. confront (e.g., precuneus; postcentral gyrus). There was no evidence of a significant group × time interaction. However, brain change in response to therapist language (complex reflection vs. confront) in regions such as middle frontal gyrus, was associated with reductions in problem drinking at 12 months. Yet, few treatment group differences were observed.
CONCLUSIONS


These data underscore the need to better understand therapist language and it's impact on the developing brain, in order to inform and aggregate the most impactful elements of addiction treatment for future treatment development for adolescents.",2022,"RESULTS


Youth in both treatment groups showed significant problem drinking reductions at 3 and 6 months, but MI youth demonstrated significantly better treatment outcomes than BAM youth at 12 months.",['163 adolescents (ages 15-19) randomized to'],"['fMRI paradigm', 'motivational interviewing (MI) vs. brief adolescent mindfulness (BAM']",['problem drinking reductions'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",163.0,0.062981,"RESULTS


Youth in both treatment groups showed significant problem drinking reductions at 3 and 6 months, but MI youth demonstrated significantly better treatment outcomes than BAM youth at 12 months.","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Mackiewicz Seghete', 'Affiliation': 'Oregon Health & Science University, Department of Psychiatry, 3181 SW Sam Jackson Park Rd, M/C UHN80R1, Portland, OR 97239, USA. Electronic address: mackiewi@ohsu.edu.'}, {'ForeName': 'Francesca M', 'Initials': 'FM', 'LastName': 'Filbey', 'Affiliation': 'Center for BrainHealth, School of Behavioral and Brain Sciences, The University of Texas at Dallas, 2200 West Mockingbird Lane, Dallas, TX 75235, USA. Electronic address: Francesca.filbey@utdallas.edu.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Hudson', 'Affiliation': 'Departments of Psychology and Interdisciplinary Neuroscience, University of Rhode Island, 130 Flagg Rd, Kingston, RI 02881 USA. Electronic address: feldsteinewing@uri.edu.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Hyun', 'Affiliation': 'Departments of Psychology and Interdisciplinary Neuroscience, University of Rhode Island, 130 Flagg Rd, Kingston, RI 02881 USA. Electronic address: hudsonk@uri.edu.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Departments of Psychology and Interdisciplinary Neuroscience, University of Rhode Island, 130 Flagg Rd, Kingston, RI 02881 USA. Electronic address: feldsteinewing@uri.edu.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2022.102960']
461,35175971,Randomized Trial of a Web-Based Tobacco Treatment and Online Community Support for People With HIV Attempting to Quit Smoking Cigarettes.,"BACKGROUND


Persons with HIV (PWH) in the United States (US) smoke cigarettes at approximately triple the rate of the general adult population and are less successful in their quit attempts than other smokers. This randomized trial tested whether a novel web-based cessation program for PWH yielded higher cigarette quit rates compared with a control program.
SETTING


Two urban HIV care sites in NYC and Baltimore.
METHODS


Between 2016 and 2020, 506 PWH were randomized to either Positively Smoke Free on the Web (PSFW+; N = 255), a multimodal platform, interactive web intervention hosted within an online social network to support quitting among PWH who smoke, and an attention-matched web-based control intervention (American Heart Association Getting Healthy; N = 251). All participants were offered 12 weeks of nicotine patch. Our primary outcome was biochemically confirmed exhaled carbon monoxide < 10 parts per million (ppm) 7-day point prevalence abstinence at 6 months.
RESULTS


Participants were middle-aged (mean 50.2 years; range 23-73 years), 57% male, 19% Latinx, 83% Black, and 13% White. At 6 months, a significantly greater percentage of PSFW+ participants (14.9%) achieved biochemically confirmed 7-day point prevalence abstinence in intent-to-treat analysis compared with 8.8% of American Heart Association Getting Healthy participants [odds ratio =1.82 (95% confidence interval =1.04 to 3.18), P = 0.03].
CONCLUSIONS


PSFW+ is a promising cessation intervention composed of empirically tested content and real-time social support through an online social network that was found to promote abstinence. This digital approach has broad reach and scalability, can be easily integrated into comprehensive HIV care, and represents an advance in the fight against tobacco use among PWH.",2022,"This randomized trial tested whether a novel web-based cessation program for PWH yielded higher cigarette quit rates compared to a control program.
","['Two urban HIV care sites in NYC and Baltimore', 'people with HIV attempting to quit smoking cigarettes', ' 506 PWH', 'Persons with HIV (PWH', 'Participants were middle-aged (mean 50.2 yrs; range 23-73), 57% male, and 19% Latinx, 83% Black, 13% White', 'Between 2016 and 2020']","['Positively Smoke Free on the Web (PSFW+; N=255), a multimodal platform, interactive web intervention hosted within an online social network to support quitting among PWH who smoke, and an attention-matched web-based control intervention', 'web-based tobacco treatment and online community support', 'PSFW', 'nicotine patch']","['cigarette quit rates', 'exhaled carbon monoxide (ECO)<10 parts per million (ppm) seven-day point prevalence abstinence']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",506.0,0.10897,"This randomized trial tested whether a novel web-based cessation program for PWH yielded higher cigarette quit rates compared to a control program.
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuter', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Graham', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC.'}, {'ForeName': 'Ryung S', 'Initials': 'RS', 'LastName': 'Kim', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Cassandra A', 'Initials': 'CA', 'LastName': 'Stanton', 'Affiliation': 'Behavioral Health and Health Policy Practice, Rockville, MD; and.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002936']
462,35175622,Time to onset of cannabidiol treatment effect and resolution of adverse events in tuberous sclerosis complex: Post hoc analysis of randomized controlled phase 3 trial GWPCARE6.,"OBJECTIVE


To estimate the timing of cannabidiol (CBD) treatment effect (seizure reduction and adverse events [AEs]) onset, we conducted a post hoc analysis of GWPCARE6 (NCT02544763), a randomized, placebo-controlled, phase 3 trial in patients with drug-resistant epilepsy associated with tuberous sclerosis complex (TSC).
METHODS


Patients received plant-derived pharmaceutical formulation of highly purified CBD (Epidiolex; 100 mg/ml oral solution) at 25 mg/kg/day (CBD25) or 50 mg/kg/day (CBD50) or placebo for 16 weeks (4-week titration, 12-week maintenance). Treatment started at 5 mg/kg/day for all groups and reached 25 mg/kg/day on Day 9 and 50 mg/kg/day on Day 29. Percentage change from baseline in TSC-associated seizure (countable focal or generalized) count was calculated by cumulative day (i.e., including all previous days). Time to onset and resolution of AEs were evaluated.
RESULTS


Of 224 patients, 75 were randomized to CBD25, 73 to CBD50, and 76 to placebo. Median (range) age was 11.3 (1.1-56.8) years. Patients had discontinued a median (range) of 4 (0-15) antiseizure medications and were currently taking 3 (0-5). Difference in seizure reduction between CBD and placebo emerged on Day 6 (titrated dose, 15 mg/kg/day) and became nominally significant (p < .049) by Day 10. Separation between placebo and CBD in ≥50% responder rate also emerged by Day 10. Onset of AEs occurred during the first 2 weeks of the titration period in 61% of patients (CBD25, 61%; CBD50, 67%; placebo, 54%). In patients with an AE, resolution occurred within 4 weeks of onset in 42% of placebo and 27% of CBD patients and by end of trial in 78% of placebo and 51% of CBD patients.
SIGNIFICANCE


Onset of treatment effect occurred within 6-10 days. AEs lasted longer for CBD than placebo, but the most common (diarrhea, decreased appetite, and somnolence) resolved during the 16-week trial in most patients.",2022,"AEs lasted longer for CBD than placebo but the most common (diarrhea, decreased appetite, and somnolence) resolved during the 16-week trial in most patients.","['Median (range) age was 11.3 (1.1-56.8) years', 'patients with drug-resistant epilepsy associated with tuberous sclerosis complex (TSC', 'Of 224 patients', 'Patients had discontinued a median (range) of 4 (0-15) antiseizure medications and were currently taking 3 (0-5', 'Patients received', 'Tuberous Sclerosis Complex']","['cannabidiol (CBD', 'placebo', 'plant-derived pharmaceutical formulation of highly purified CBD (Epidiolex ®  ; 100 mg/mL oral solution', 'placebo and CBD']","['appetite, and somnolence', 'Time to Onset of Cannabidiol (CBD) Treatment Effect and Resolution of Adverse Events', 'Onset of AEs', 'seizure reduction', 'Time to onset and resolution of AEs']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4731581', 'cui_str': 'Epidiolex'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",224.0,0.346379,"AEs lasted longer for CBD than placebo but the most common (diarrhea, decreased appetite, and somnolence) resolved during the 16-week trial in most patients.","[{'ForeName': 'Joyce Y', 'Initials': 'JY', 'LastName': 'Wu', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.""}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Cock', 'Affiliation': ""St George's University Hospitals National Health Service Foundation Trust, St George's University of London, London, UK.""}, {'ForeName': 'Orrin', 'Initials': 'O', 'LastName': 'Devinsky', 'Affiliation': 'Comprehensive Epilepsy Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Charuta', 'Initials': 'C', 'LastName': 'Joshi', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Miller', 'Affiliation': ""Nicklaus Children's Hospital, Miami, Florida, USA.""}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'Roberts', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Sanchez-Carpintero', 'Affiliation': 'University of Navarra Clinic, Pamplona, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research, Cambridge, UK.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Sahebkar', 'Affiliation': 'Greenwich Biosciences, Carlsbad, California, USA.'}]",Epilepsia,['10.1111/epi.17199']
463,35176287,Letter to the Editor: Effectiveness of a Functional Rehabilitation Program for Upper Limb Apraxia in Poststroke Patients: A Randomized Controlled Trial.,,2022,,['Upper Limb Apraxia in Poststroke Patients'],['Functional Rehabilitation Program'],[],"[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0327661,,"[{'ForeName': 'Yousuke', 'Initials': 'Y', 'LastName': 'Bandai', 'Affiliation': 'Department of Rehabilitation Medicine, Shimada Hospital, Shimada Social Medical Corporation Social Medical Corporation, Fukuoka, Japan; Department of Physical Therapy, School of Health Sciences at Fukuoka, International University of Health and Welfare, Fukuoka, Japan. Electronic address: yousuke.bandai@gmail.com.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ariie', 'Affiliation': 'Department of Rehabilitation Medicine, Shimada Hospital, Shimada Social Medical Corporation Social Medical Corporation, Fukuoka, Japan; Department of Physical Therapy, School of Health Sciences at Fukuoka, International University of Health and Welfare, Fukuoka, Japan.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2022.01.152']
464,35176952,"Sleep, alertness and performance across a first and a second night shift in mining haul truck drivers.","This study examined the impact of first and second night shift work on sleep and performance in mining haul truck drivers. Sleep-wake patterns were monitored using wrist actigraphy. The Karolinska Sleepiness Scale (KSS), Psychomotor Vigilance Test (PVT) and a truck simulator were administered at the start and end of the first (N1) or second (N2) night shift (19:00-07:00 h). Participants were categorised into those who demonstrated a decline in performance (increase of one or more PVT lapses [reaction time >500 msec] from the start to the end of shift) or those who did not demonstrate a decline in performance (no increase in lapses) from the start to the end of shift. Total sleep time (TST) was longer in the 24 h prior to N1 (9.05 ± 1.49 h) compared to N2 (5.38 ± 1.32 h). PVT lapses and the slowest 10% of reaction times were similar at the start and end of N1, while greater impairments on these outcomes were observed at the end of N2 compared to the end of N1 ( p  < .05). In contrast, subjective sleepiness was equally impaired at the end of both night shifts. PVT performance (lapses and slowest 10% of reaction times) and drive violations demonstrated a similar direction of change on N1 and N2. Participants who demonstrated a decline in performance showed reduced TST in the 48 h prior to shifts compared to those who demonstrated no decline in performance across the shift. Likely due to short sleep prior, the end of N2 was associated with pronounced performance impairments on the PVT and drive violations compared to the start of the shift. The findings suggest that drive violations may be more sensitive to sleep loss compared to the other driving measures examined in this study. This study also emphasizes the need for adequate recovery sleep between night shifts.",2022,Total sleep time (TST) was longer in the 24 h prior to N1 (9.05 ± 1.49 h) compared to N2 (5.38 ± 1.32 h).,['mining haul truck drivers'],[],"['PVT lapses', 'subjective sleepiness', 'Sleep-wake patterns', 'TST', 'sleep and performance', 'PVT performance (lapses and slowest 10% of reaction times) and drive violations', 'Sleep, alertness and performance across a first and a second night shift', 'Karolinska Sleepiness Scale (KSS), Psychomotor Vigilance Test (PVT) and a truck simulator', 'lapses', 'Total sleep time (TST']","[{'cui': 'C0026175', 'cui_str': 'Mining'}, {'cui': 'C0557776', 'cui_str': 'Truck'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]",[],"[{'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0557776', 'cui_str': 'Truck'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]",,0.0696885,Total sleep time (TST) was longer in the 24 h prior to N1 (9.05 ± 1.49 h) compared to N2 (5.38 ± 1.32 h).,"[{'ForeName': 'Saranea', 'Initials': 'S', 'LastName': 'Ganesan', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Manousakis', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Megan D', 'Initials': 'MD', 'LastName': 'Mulhall', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Sletten', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tucker', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Australia.'}]",Chronobiology international,['10.1080/07420528.2022.2034838']
465,35180784,Comparison of Outcomes of External Dacryocystorhinostomy and Transcanalicular Laser-Assisted Dacryocystorhinostomy in Patients with Primary Acquired Nasolacrimal Duct Obstruction.,"PURPOSE


This study aimed to compare anatomical and functional outcomes of external dacryocystorhinostomy (EX-DCR) and transcanalicular multidiode laser dacryocystorhinostomy (TDL-DCR) in patients with primary acquired nasolacrimal duct obstruction (PANDO).
METHODS


This study was conducted on 60 eyes of 60 patients with PANDO. The study subjects were randomly divided into two groups. Group 1 included 30 patients who underwent EX-DCR, and group 2 included 30 patients who underwent TDL-DCR. Surgery success rates were determined by patency of the neo-ostium, with free saline flow on irrigation and the absence of epiphora.
RESULTS


There were 23 women (76.7%) and 7 men (23.3%) with a mean age of 47.33 ± 12.44 years in group 1, and 18 women (60%) and 12 men (40%) with a mean age of 46.2 ± 19.4 years in group 2. There was no significant difference between groups 1 and 2 with respect to age or gender (p = 0.801, p = 0.267, respectively). The mean duration of symptoms was 3.2 years, ranging from 1.5 to 5 years. The mean postoperative follow-up was 12.3 ± 2.44 months. At the end of the follow-up period, the surgery success rates were 96.7% (29/30 eyes) in group 1, and 90% (27/30 eyes) in group 2. There was no statistical difference in the surgery success rates between groups (p = 0.612).
CONCLUSION


TDL-DCR is a minimally invasive and safe procedure. The lack of bleeding and incision scar and shorter operation time suggest that TDL-DCR can be a good alternative in PANDO patients.",2022,"There was no significant difference between groups 1 and 2 with respect to age or gender (p = 0.801, p = 0.267, respectively).","['Patients with Primary Acquired Nasolacrimal Duct Obstruction', 'patients with primary acquired nasolacrimal duct obstruction (PANDO', '23 women (76.7%) and 7 men (23.3%) with a mean age of 47.33\u2009±\u200912.44 years in group 1, and 18\xa0women (60%) and 12 men (40%) with a mean age of 46.2\u2009±\u200919.4 years in group 2', '60 eyes of 60 patients with PANDO']","['external dacryocystorhinostomy (EX-DCR) and transcanalicular multidiode laser dacryocystorhinostomy (TDL-DCR', 'External Dacryocystorhinostomy and Transcanalicular Laser-Assisted Dacryocystorhinostomy', 'TDL-DCR', 'EX-DCR']","['surgery success rates', 'Surgery success rates', 'mean duration of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282418', 'cui_str': 'Primary acquired nasolacrimal duct obstruction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}]",60.0,0.015453,"There was no significant difference between groups 1 and 2 with respect to age or gender (p = 0.801, p = 0.267, respectively).","[{'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'Mutlu', 'Affiliation': 'Department of Ophthalmology, Kayseri City Education and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Nurettin', 'Initials': 'N', 'LastName': 'Bayram', 'Affiliation': 'Department of Ophthalmology, Kayseri City Education and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Mustafa Kemal', 'Initials': 'MK', 'LastName': 'Arici', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Ayse Vural', 'Initials': 'AV', 'LastName': 'Ozec', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Haydar', 'Initials': 'H', 'LastName': 'Erdogan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Mustafa Ilker', 'Initials': 'MI', 'LastName': 'Toker', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}]",Klinische Monatsblatter fur Augenheilkunde,['10.1055/a-1720-1752']
466,35179551,Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and Comorbidities: The I-TECH Randomized Clinical Trial.,"Importance


Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19. Evidence-based data to recommend either for or against the use of ivermectin are needed.
Objective


To determine the efficacy of ivermectin in preventing progression to severe disease among high-risk patients with COVID-19.
Design, Setting, and Participants


The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients' symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease.
Interventions


Patients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.
Main Outcomes and Measures


The primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events.
Results


Among 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group).
Conclusions and Relevance


In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19.
Trial Registration


ClinicalTrials.gov Identifier: NCT04920942.",2022,"Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).","['Adults With Mild to Moderate COVID-19 and Comorbidities', 'high-risk patients with COVID-19', ""patients' symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease"", 'patients with COVID-19', '20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021', '490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the', 'high-risk patients with mild to moderate COVID-19']","['ivermectin', 'Ivermectin', 'oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n\u2009=\u2009241) or standard of care alone']","['hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation', 'severe disease', 'diarrhea', '28-day in-hospital death', 'Mechanical ventilation', 'intensive care unit admission', 'rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events', 'proportion of patients who progressed to severe disease']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0560741', 'cui_str': 'mg/kg body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",,0.715363,"Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).","[{'ForeName': 'Steven Chee Loon', 'Initials': 'SCL', 'LastName': 'Lim', 'Affiliation': 'Department of Medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.'}, {'ForeName': 'Chee Peng', 'Initials': 'CP', 'LastName': 'Hor', 'Affiliation': 'Department of Medicine, Kepala Batas Hospital, Penang, Malaysia.'}, {'ForeName': 'Kim Heng', 'Initials': 'KH', 'LastName': 'Tay', 'Affiliation': 'Department of Medicine, Sungai Buloh Hospital, Selangor, Malaysia.'}, {'ForeName': 'Anilawati', 'Initials': 'A', 'LastName': 'Mat Jelani', 'Affiliation': 'Department of Medicine, Tumpat Hospital, Kelantan, Malaysia.'}, {'ForeName': 'Wen Hao', 'Initials': 'WH', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Taiping Hospital, Perak, Malaysia.'}, {'ForeName': 'Hong Bee', 'Initials': 'HB', 'LastName': 'Ker', 'Affiliation': 'Department of Medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.'}, {'ForeName': 'Ting Soo', 'Initials': 'TS', 'LastName': 'Chow', 'Affiliation': 'Department of Medicine, Penang Hospital, Penang, Malaysia.'}, {'ForeName': 'Masliza', 'Initials': 'M', 'LastName': 'Zaid', 'Affiliation': 'Department of Medicine, Sultanah Aminah Hospital, Johor, Malaysia.'}, {'ForeName': 'Wee Kooi', 'Initials': 'WK', 'LastName': 'Cheah', 'Affiliation': 'Department of Medicine, Taiping Hospital, Perak, Malaysia.'}, {'ForeName': 'Han Hua', 'Initials': 'HH', 'LastName': 'Lim', 'Affiliation': 'Department of Medicine, Sarawak General Hospital, Sarawak, Malaysia.'}, {'ForeName': 'Khairil Erwan', 'Initials': 'KE', 'LastName': 'Khalid', 'Affiliation': 'Department of Medicine, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Joo Thye', 'Initials': 'JT', 'LastName': 'Cheng', 'Affiliation': 'Department of Medicine, Kepala Batas Hospital, Penang, Malaysia.'}, {'ForeName': 'Hazfadzila', 'Initials': 'H', 'LastName': 'Mohd Unit', 'Affiliation': 'Department of Medicine, Sultanah Nur Zahirah Hospital, Terengganu, Malaysia.'}, {'ForeName': 'Noralfazita', 'Initials': 'N', 'LastName': 'An', 'Affiliation': 'Department of Medicine, Sultan Abdul Halim Hospital, Kedah, Malaysia.'}, {'ForeName': 'Azraai Bahari', 'Initials': 'AB', 'LastName': 'Nasruddin', 'Affiliation': 'Department of Medicine, Putrajaya Hospital, Putrajaya, Malaysia.'}, {'ForeName': 'Lee Lee', 'Initials': 'LL', 'LastName': 'Low', 'Affiliation': 'Department of Medicine, Sultanah Bahiyah Hospital, Kedah, Malaysia.'}, {'ForeName': 'Song Weng Ryan', 'Initials': 'SWR', 'LastName': 'Khoo', 'Affiliation': 'Department of Medicine, Lahad Datu Hospital, Sabah, Malaysia.'}, {'ForeName': 'Jia Hui', 'Initials': 'JH', 'LastName': 'Loh', 'Affiliation': 'Department of Medicine, Duchess of Kent Hospital, Sabah, Malaysia.'}, {'ForeName': 'Nor Zaila', 'Initials': 'NZ', 'LastName': 'Zaidan', 'Affiliation': 'Department of Medicine, Melaka Hospital, Malacca, Malaysia.'}, {'ForeName': 'Suhaila', 'Initials': 'S', 'LastName': 'Ab Wahab', 'Affiliation': 'Department of Medicine, Tuanku Fauziah Hospital, Perlis, Malaysia.'}, {'ForeName': 'Li Herng', 'Initials': 'LH', 'LastName': 'Song', 'Affiliation': 'Clinical Research Centre, Raja Permaisuri Bainun Hospital, Perak, Malaysia.'}, {'ForeName': 'Hui Moon', 'Initials': 'HM', 'LastName': 'Koh', 'Affiliation': 'Department of Pharmacy, Sungai Buloh Hospital, Selangor, Malaysia.'}, {'ForeName': 'Teck Long', 'Initials': 'TL', 'LastName': 'King', 'Affiliation': 'Clinical Research Centre, Sarawak General Hospital, Sarawak, Malaysia.'}, {'ForeName': 'Nai Ming', 'Initials': 'NM', 'LastName': 'Lai', 'Affiliation': ""School of Medicine, Taylor's University, Selangor, Malaysia.""}, {'ForeName': 'Suresh Kumar', 'Initials': 'SK', 'LastName': 'Chidambaram', 'Affiliation': 'Department of Medicine, Sungai Buloh Hospital, Selangor, Malaysia.'}, {'ForeName': 'Kalaiarasu M', 'Initials': 'KM', 'LastName': 'Peariasamy', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Selangor, Malaysia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2022.0189']
467,35182393,"Comparing impacts of meditation training in focused attention, open monitoring, and mindfulness-based cognitive therapy on emotion reactivity and regulation: Neural and subjective evidence from a dismantling study.","Commonly conducted mindfulness-based trainings such as Mindfulness-based Stress Reduction (MBSR) and Mindfulness-based Cognitive Therapy (MBCT) highlight training in two key forms of meditation: focused attention (FA) and open monitoring (OM). Largely unknown is what each of these mindfulness practices contributes to emotional and other important training outcomes. This dismantling trial compared the effects of structurally equivalent trainings in MBCT, FA, and OM on neural and subjective markers of emotional reactivity and regulation among community adults, with the aim to better understand which forms of training represent active ingredients in mindfulness trainings. Participants with varying levels of depressive symptoms were randomized to one of the three trainings. Before and after each 8-week training, N = 89 participants completed a modified version of the Emotional Reactivity and Regulation Task while electroencephalographic (EEG) and self-reported emotional responses to negative, positive, and neutral photographic images were collected. Examination of EEG-based frontal alpha band asymmetry during passive viewing (reactivity) and active regulation phases of the task showed that FA and MBCT trainings produced significant leftward hemispheric shifts in frontal alpha asymmetry, commonly associated with a shift toward approach-based positive affect. Self-reported emotional responses to negative images corroborated these results, suggesting salutary changes in both emotional reactivity and regulation. OM training had limited beneficial effects, restricted to the subjective outcomes. The findings suggest that MBCT may derive its greatest benefit from training in FA rather than OM. Discussion highlights the potential value of FA training for emotional health.",2022,"Before and after each 8-week training, N = 89 participants completed a modified version of the Emotional Reactivity and Regulation Task while electroencephalographic (EEG) and self-reported emotional responses to negative, positive, and neutral photographic images were collected.","['community adults', 'Participants with varying levels of depressive symptoms']","['FA training', 'FA and MBCT trainings', 'attention (FA) and open monitoring (OM', 'MBCT', 'mindfulness-based trainings such as Mindfulness-based Stress Reduction (MBSR) and Mindfulness-based Cognitive Therapy (MBCT) highlight training', 'meditation training', 'OM training', 'mindfulness-based cognitive therapy']","['Emotional Reactivity and Regulation Task while electroencephalographic (EEG) and self-reported emotional responses to negative, positive, and neutral photographic images']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0589098', 'cui_str': 'Focused attention'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",89.0,0.0282215,"Before and after each 8-week training, N = 89 participants completed a modified version of the Emotional Reactivity and Regulation Task while electroencephalographic (EEG) and self-reported emotional responses to negative, positive, and neutral photographic images were collected.","[{'ForeName': 'Kirk Warren', 'Initials': 'KW', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Berry', 'Affiliation': 'Department of Psychology, California State University, San Marcos, San Marcos, California, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Eichel', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Beloborodova', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Hadley', 'Initials': 'H', 'LastName': 'Rahrig', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Willoughby B', 'Initials': 'WB', 'LastName': 'Britton', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, Rhode Island, USA.'}]",Psychophysiology,['10.1111/psyp.14024']
468,35181523,Long-term Outcomes Following Surgical Management of Rectal Endometriosis: Seven-year Follow-up of Patients Enrolled in a Randomized Trial.,"STUDY OBJECTIVE


To compare functional outcomes, recurrence rate, and pregnancy likelihood in patients undergoing conservative or radical surgery for deep rectal endometriosis followed up for 7 years.
DESIGN


Prospective study in a cohort of patients enrolled in a 2-arm randomized trial from March 2011 to August 2013.
SETTING


A tertiary referral center.
PATIENTS


Fifty-five patients with deep endometriosis infiltrating the rectum.
INTERVENTIONS


Patients underwent either segmental resection or nodule excision via shaving or disk excision, depending on randomization that was performed preoperatively using sequentially numbered, opaque sealed envelopes.
MEASUREMENTS AND MAIN RESULTS


The primary end point was the number of patients experiencing one of the following symptoms: constipation, frequent bowel movements, anal incontinence, or bladder dysfunction 24 months after surgery. The secondary end points were values of gastrointestinal and overall quality of life scores. The 7-year recurrence rates (new deep endometriosis nodules infiltrating the rectum) in the excision vs segmental resection arms were 7.4 % vs 0% (p = .24). One of the symptoms included in the definition of the primary outcomes was recorded in 55.6% vs 60.7% of patients (p = .79). However, 51.9% vs 53.6% of patients considered their bowel movements as normal (p = .99). An intention-to-treat comparison of overall quality of life scores did not find a difference between the 2 groups 7 years after surgery. At the end of the 7-year study period, 31 of 37 patients who tried to conceive were successful (83.8%), including 27 pregnancies (57.4%) resulting from natural conception and 20 pregnancies (42.6%) resulting from assisted reproductive technology procedures. The pregnancy rate was 82.4% vs 85% in the 2 arms (p = .99). A 75.7% live birth rate was recorded. At the end of the follow-up, there were 15 women with 1 child (40.5%) and 13 women with 2 children (35.1%). During the 7-year follow-up, the reoperation rates were 37% and 35.7%, respectively, in each arm (p = .84). Among the 27 reoperation procedures during the follow-up period, 11 (40.7%) were for postoperative complications, 7 (25.9%) were necessary before assisted reproductive technology management, 8 (29.6%) were for recurrent abdominal or pelvic pain, and 1 (3.7%) was for midline ventral hernia after pregnancy.
CONCLUSION


Our study did not reveal a considerable difference in terms of digestive functional outcomes, recurrence rate, reoperation risk, and pregnancy likelihood when conservative and radical rectal surgeries for deep endometriosis were compared 7 years after surgery. The postoperative pregnancy rate observed in our series was high.",2022,An intention-to-treat comparison of overall quality of life scores did not find differences between the two groups 7 years postoperatively.,"['patients enrolled in a 2-arm randomized trial from March 2011 to August 2013', 'patients undergoing', 'patients with deep rectal endometriosis 7 years post-operatively', 'rectal endometriosis', '55 patients with deep endometriosis infiltrating the rectum', 'A tertiary referral center', '37 patients who tried to conceive were successful (83.8%) including: 27 (57.4%) natural conceptions and 20 (42.6%) pregnancies resulting from ART procedures', '15 women with one child (40.5%) and 13 women with 2 children (35.1']","['segmental resection or nodule excision by shaving or disc excision', 'conservative or radical surgery']","['Pregnancy rate', 'reoperation rate', 'recurrence rate and pregnancy likelihood', 'live birth rate', 'Postoperative pregnancy rate', 'overall quality of life scores', 'postoperative complications', 'digestive functional outcomes, recurrence rate, reoperation risk and pregnancy likelihood', 'recurrent abdominal or pelvic pain', 'number of patients experiencing one of the following symptoms: constipation, frequent bowel movements, anal incontinence or bladder dysfunction 24 months postoperatively', 'values of gastrointestinal and overall quality of life scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4510788', 'cui_str': 'Deep endometriosis'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0420843', 'cui_str': 'Trying to conceive'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2939022', 'cui_str': 'Nodule excision'}, {'cui': 'C0518505', 'cui_str': 'Does shave'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0239978', 'cui_str': 'Increased frequency of defecation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0232841', 'cui_str': 'Bladder dysfunction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",15.0,0.114972,An intention-to-treat comparison of overall quality of life scores did not find differences between the two groups 7 years postoperatively.,"[{'ForeName': 'Horace', 'Initials': 'H', 'LastName': 'Roman', 'Affiliation': 'Franco-European Multidisciplinary Institute of Endometriosis (Dr. Roman), Clinique Tivoli-Ducos, Bordeaux, France; Department of Obstetrics and Gynecology (Dr. Roman), Aarhus University Hospital, Aarhus, Denmark. Electronic address: horace.roman@gmail.com.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Huet', 'Affiliation': 'Department of Surgery (Drs. Huet, Bridoux, Khalil, and Tuech), Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Bridoux', 'Affiliation': 'Department of Surgery (Drs. Huet, Bridoux, Khalil, and Tuech), Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Khalil', 'Affiliation': 'Department of Surgery (Drs. Huet, Bridoux, Khalil, and Tuech), Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Hennetier', 'Affiliation': 'Expert Center in the Diagnosis and Multidisciplinary Management of Endometriosis (Drs. Hennetier and Braund), Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bubenheim', 'Affiliation': 'Departments of Statistics (Dr. Bubenheim), Rouen University Hospital, Rouen.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Braund', 'Affiliation': 'Expert Center in the Diagnosis and Multidisciplinary Management of Endometriosis (Drs. Hennetier and Braund), Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Department of Surgery (Drs. Huet, Bridoux, Khalil, and Tuech), Rouen University Hospital, Rouen, France.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2022.02.007']
469,35179323,"Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer.","BACKGROUND


Darolutamide is a potent androgen-receptor inhibitor that has been associated with increased overall survival among patients with nonmetastatic, castration-resistant prostate cancer. Whether a combination of darolutamide, androgen-deprivation therapy, and docetaxel would increase survival among patients with metastatic, hormone-sensitive prostate cancer is unknown.
METHODS


In this international, phase 3 trial, we randomly assigned patients with metastatic, hormone-sensitive prostate cancer in a 1:1 ratio to receive darolutamide (at a dose of 600 mg [two 300-mg tablets] twice daily) or matching placebo, both in combination with androgen-deprivation therapy and docetaxel. The primary end point was overall survival.
RESULTS


The primary analysis involved 1306 patients (651 in the darolutamide group and 655 in the placebo group); 86.1% of the patients had disease that was metastatic at the time of the initial diagnosis. At the data cutoff date for the primary analysis (October 25, 2021), the risk of death was significantly lower, by 32.5%, in the darolutamide group than in the placebo group (hazard ratio 0.68; 95% confidence interval, 0.57 to 0.80; P<0.001). Darolutamide was also associated with consistent benefits with respect to the secondary end points and prespecified subgroups. Adverse events were similar in the two groups, and the incidences of the most common adverse events (occurring in ≥10% of the patients) were highest during the overlapping docetaxel treatment period in both groups. The frequency of grade 3 or 4 adverse events was 66.1% in the darolutamide group and 63.5% in the placebo group; neutropenia was the most common grade 3 or 4 adverse event (in 33.7% and 34.2%, respectively).
CONCLUSIONS


In this trial involving patients with metastatic, hormone-sensitive prostate cancer, overall survival was significantly longer with the combination of darolutamide, androgen-deprivation therapy, and docetaxel than with placebo plus androgen-deprivation therapy and docetaxel, and the addition of darolutamide led to improvement in key secondary end points. The frequency of adverse events was similar in the two groups. (Funded by Bayer and Orion Pharma; ARASENS ClinicalTrials.gov number, NCT02799602.).",2022,Darolutamide was also associated with consistent benefits with respect to the secondary end points and prespecified subgroups.,"['patients with nonmetastatic, castration-resistant prostate cancer', 'patients with metastatic, hormone-sensitive prostate cancer in a 1:1 ratio to receive', 'patients with metastatic, hormone-sensitive prostate cancer', '1306 patients (651 in the darolutamide group and 655 in the placebo group); 86.1% of the patients had disease that was metastatic at the time of the initial diagnosis']","['darolutamide (at a dose of 600 mg [two 300-mg tablets] twice daily) or matching placebo, both in combination with androgen-deprivation therapy and docetaxel', 'placebo plus androgen-deprivation therapy and docetaxel', 'placebo', 'darolutamide, androgen-deprivation therapy, and docetaxel']","['frequency of grade 3 or 4 adverse events', 'survival', 'neutropenia', 'overall survival', 'risk of death', 'frequency of adverse events', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1306.0,0.767061,Darolutamide was also associated with consistent benefits with respect to the secondary end points and prespecified subgroups.,"[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'E David', 'Initials': 'ED', 'LastName': 'Crawford', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kopyltsov', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Chandler H', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Montesa-Pino', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Parnis', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Cruz', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Utriainen', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Méndez-Vidal', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Maughan', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Joensuu', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Thiele', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kuss', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'From the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2119115']
470,35181234,Feasibility and Usefulness of Self-Hypnosis in Patients Undergoing Double-Lung Transplantation During the Pre- and Postoperative Periods: A Randomized Study.,"OBJECTIVE


Hypnosis can reduce pain and anxiety in surgical patients. This study aimed to demonstrate that implementing self-hypnosis in the setting of lung transplantation could improve patients' pain and quality of life.
DESIGN


A randomized, single-center study.
SETTING


Foch University Hospital, Suresnes, France.
PARTICIPANTS


The participants were patients aged 15 years or older who needed a double-lung transplant. Patients were excluded if they participated in only 1 learning self-hypnosis session before transplantation.
INTERVENTIONS


Patients were included at the time of their final evaluation before inscription on the waiting list. They were taught self-hypnosis at this time and were asked to perform it by themselves before and after transplantation, as frequently as possible.
MEASUREMENTS AND MAIN RESULTS


The main outcome of the study was self-reported pain 1 month after lung transplantation. Secondary outcomes were self-reported pain, anxiety, coping, catastrophism, and self-reported quality of life evaluated at their registration, 7 days and 1 and 4 months after the transplantation. Seventy-eight patients were included, but only 28 patients in the control group and 33 in the self-hypnosis group were evaluated at the fourth postoperative month. Practice of self-hypnosis was high before transplantation (76.6%), lower after, from 32.3% in the intensive care unit to 51.6% during the last 3 months of the study. Group-time interactions were not statistically significant whatever the concerned outcome, especially pain score at 1 month (p = 0.16).
CONCLUSION


Implementation of self-hypnosis is possible, but the study failed to demonstrate an improvement in patients' experience, perhaps due to the variable compliance with the technique.",2022,"Practice of self-hypnosis was high before transplantation (76.6%), lower after, from 32.3% in the intensive care unit to 51.6% during the last 3 months of the study.","['Seventy-eight patients were included, but only 28 patients in the control group and 33 in the self-hypnosis group', 'Patients were excluded if they participated in only 1 learning self-hypnosis session before transplantation', 'surgical patients', 'participants were patients aged 15 years or older who needed a double-lung transplant', 'Foch University Hospital, Suresnes, France', 'Patients Undergoing Double-Lung Transplantation']",['Self-Hypnosis'],"['self-reported pain, anxiety, coping, catastrophism, and self-reported quality of life evaluated at their registration', 'pain and anxiety', ""patients' pain and quality of life"", 'pain score']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0396599', 'cui_str': 'Double lung transplant'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",78.0,0.0728359,"Practice of self-hypnosis was high before transplantation (76.6%), lower after, from 32.3% in the intensive care unit to 51.6% during the last 3 months of the study.","[{'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Michel-Cherqui', 'Affiliation': 'Department of Anesthesiology and Pain Management Clinic, Hôpital Foch, Suresnes, France; Université Versailles-Saint-Quentin-en-Yvelines, Versailles, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Szekely', 'Affiliation': 'Department of Anesthesiology and Pain Management Clinic, Hôpital Foch, Suresnes, France; Université Versailles-Saint-Quentin-en-Yvelines, Versailles, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Fessler', 'Affiliation': 'Department of Anesthesiology and Pain Management Clinic, Hôpital Foch, Suresnes, France; Université Versailles-Saint-Quentin-en-Yvelines, Versailles, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Glorion', 'Affiliation': 'Université Versailles-Saint-Quentin-en-Yvelines, Versailles, France; Department of Thoracic Surgery and Lung Transplantation, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Sage', 'Affiliation': 'Université Versailles-Saint-Quentin-en-Yvelines, Versailles, France; Department of Thoracic Surgery and Lung Transplantation, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Department of Anesthesiology and Pain Management Clinic, Hôpital Foch, Suresnes, France; Université Versailles-Saint-Quentin-en-Yvelines, Versailles, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Trichereau', 'Affiliation': 'Department of Clinical Research and Innovation, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Vallée', 'Affiliation': 'Department of Clinical Research and Innovation, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': 'Department of Anesthesiology and Pain Management Clinic, Hôpital Foch, Suresnes, France; Université Versailles-Saint-Quentin-en-Yvelines, Versailles, France. Electronic address: m.fischler@hopital-foch.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2022.01.027']
471,35183487,Scales in pain control in patients post-ictus with aphasia: A comparative study.,"The assessment of pain and its control is a key point in the care received by patients during their hospital stay, with the nurse being an essential figure, especially in stroke patients with secondary aphasia, which makes it difficult to verbalise pain. The aim of this study was to find out whether the use of a specific pain control scale and the more precise administration of analgesic treatment has a positive impact on indicators such as average stay length, dependence degree and agitation episodes. By means of a longitudinal randomised group design study, within a two-week period, we compared the management and recording of pain using a Pain Indicator Behaviour Scale (N = 41) and a Verbal Numerical Scale or Visual Analogue Scale (N = 39), in patients with language impairment after suffering a stroke who were admitted to the Stroke Unit of the Neurology Department of the Hospital Clínic de Barcelona. The results obtained, despite being in line with what was conjectured, are not statistically significant. However, some statistical models have shown the usefulness of some factors (level of training, nurses experience, previous episodes of stroke, among others) in the prediction of a better evolution, with a predictive capacity between 20-37%, which justifies the necessity of further studies and reinforces the role of the variables studied in the care of this type of patient.",2022,"The results obtained, despite being in line with what was conjectured, are not statistically significant.","['patients with language impairment after suffering a stroke who were admitted to the Stroke Unit of the Neurology Department of the Hospital Clínic de Barcelona', 'patients post-ictus with aphasia']",[],"['average stay length, dependence degree and agitation episodes', 'Verbal Numerical Scale or Visual Analogue Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023015', 'cui_str': 'Disorder of language'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0587475', 'cui_str': 'Neurology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]",[],"[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0149475,"The results obtained, despite being in line with what was conjectured, are not statistically significant.","[{'ForeName': 'Jesús B', 'Initials': 'JB', 'LastName': 'Gutiérrez-Martín', 'Affiliation': 'Enfermería asistencial Neurología, Hospital Clínic de Barcelona, Barcelona, Spain. Electronic address: jgutierr@clinic.cat.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leiva-Ureña', 'Affiliation': 'Sección de Psicología Cuantitativa, Departamento Psicología Social y Psicología Cuantitativa, Facultad de Psicología, Universidad de Barcelona, 08035, Barcelona, Spain.'}, {'ForeName': 'Aránzazu', 'Initials': 'A', 'LastName': 'Martínez-Morales', 'Affiliation': 'Enfermería asistencial Neurología, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francina', 'Initials': 'F', 'LastName': 'Salord-Oleo', 'Affiliation': 'Enfermería asistencial Neurología, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'López-Lozano', 'Affiliation': 'Enfermería asistencial Neurología, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Oliveira-Rocha-Fontao', 'Affiliation': 'Enfermería asistencial Neurología, Hospital Clínic de Barcelona, Barcelona, Spain.'}]",Enfermeria clinica (English Edition),['10.1016/j.enfcle.2021.10.004']
472,35184324,Effects of a comprehensive medication review intervention on health-related quality of life and other clinical outcomes in geriatric outpatients with polypharmacy: A pragmatic randomized clinical trial.,"AIM


To investigate the effects of a comprehensive medication review intervention on health-related quality of life (HRQoL) and clinical outcomes in geriatric outpatients exposed to polypharmacy.
METHODS


Pragmatic, nonblinded, randomized clinical trial with follow-up after 4 and 13 months. Participants were geriatric outpatients taking ≥9 medicines. The intervention was an additional consultation with a physician focusing on reviewing medication, informing patients about their medicines and increasing cross-sectoral communication as supplement to and compared with usual care. The primary outcome was change in HRQoL after 4 months measured with the EuroQoL 5-dimension 5-level (EQ-5D-5L) questionnaire. Secondary outcomes were HRQoL after 13 months, mortality, admissions, falls and number of medicines after 4 and 13 months.
RESULTS


Of 785 eligible patients, 408 were included (age: mean 80.6 [standard deviation 7.22] years; number of medicines: median 12 [interquartile range 10-14]; females 71%). After 4 months, the adjusted between-group difference in EQ-5D-5L index score was 0.066 in favour of the medication consultation (95% confidence interval 0.01 to 0.12, P = .02). After 4 months, two (1%) participants had died in the medication-consultation group and nine (4%) in the usual-care group (log-rank test, P = .045). The medication consultation reduced the number of medicines by 2.0 (15.8%) after 4 months and 1.3 (10.7%) after 13 months. There were no statistically significant differences in mortality or HRQoL after 13 months, and no differences in falls or admissions.
CONCLUSIONS


An additional consultation with medication review and increased communication as supplement to usual geriatric outpatient care improved HRQoL and reduced mortality after 4 months.",2022,The medication consultation reduced the No. medicines by 2.0 (15.8%) after 4 months and 1.3 (10.7%) after 13 months.,"['785 eligible patients', 'geriatric outpatients exposed to polypharmacy', ' 408 were included (age', 'Geriatric Outpatients with Polypharmacy', 'Participants were geriatric outpatients taking ≥ 9 medicines']","['comprehensive medication review intervention', 'additional consultation with a physician focusing on reviewing medication, informing patients about their medicines, and increasing cross-sectoral communication as supplement to and compared with usual care', 'Comprehensive Medication Review Intervention']","['HRQoL after 13 months, mortality, admissions, falls, and No. medicines', 'health-related quality of life (HRQoL', 'change in HRQoL', 'EQ-5D-5L index score', 'mortality or HRQoL', 'medication consultation', 'falls or admissions', 'HRQoL and reduced mortality', 'Health-Related Quality of Life', 'EuroQoL 5-dimension 5-level (EQ-5D-5L) questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0588446', 'cui_str': 'Informing patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0439741', 'cui_str': 'Sectoral'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",785.0,0.158351,The medication consultation reduced the No. medicines by 2.0 (15.8%) after 4 months and 1.3 (10.7%) after 13 months.,"[{'ForeName': 'Jonatan', 'Initials': 'J', 'LastName': 'Kornholt', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.'}, {'ForeName': 'Shafika Tapia', 'Initials': 'ST', 'LastName': 'Feizi', 'Affiliation': 'Department of Geriatric and Palliative Medicine, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.'}, {'ForeName': 'Alexandra Storm', 'Initials': 'AS', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.'}, {'ForeName': 'Jannie Thaysen', 'Initials': 'JT', 'LastName': 'Laursen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.'}, {'ForeName': 'Lene Ørskov', 'Initials': 'LØ', 'LastName': 'Reuther', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.'}, {'ForeName': 'Tonny Studsgaard', 'Initials': 'TS', 'LastName': 'Petersen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.'}, {'ForeName': 'Eckart', 'Initials': 'E', 'LastName': 'Pressel', 'Affiliation': 'Department of Geriatric and Palliative Medicine, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.'}, {'ForeName': 'Mikkel Bring', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.'}]",British journal of clinical pharmacology,['10.1111/bcp.15287']
473,35189093,Vaginal progesterone vs intramuscular 17-hydroxyprogesterone caproate for prevention of recurrent preterm birth: a randomized controlled trial.,"BACKGROUND


Preterm birth is the leading cause of neonatal morbidity and mortality, and previous preterm birth is one of the strongest risk factors for preterm birth. National and international obstetrical societies have different recommendations regarding progesterone formulation for the prevention of recurrent preterm birth.
OBJECTIVE


This study aimed to determine whether vaginal progesterone is superior to 17-hydroxyprogesterone caproate in the prevention of recurrent preterm birth in patients with singleton pregnancies who had a previous spontaneous preterm birth.
STUDY DESIGN


This was an open-label multicenter pragmatic randomized controlled trial at 5 US centers of patients with singleton pregnancies at <24 weeks of gestation who had a previous spontaneous preterm birth randomized 1:1 to either 200 mg vaginal progesterone suppository nightly or 250 mg intramuscular 17-hydroxyprogesterone caproate weekly from 16 to 36 weeks of gestation. Based on the estimated recurrent preterm birth rate of 36% with 17-hydroxyprogesterone caproate, 95 participants were needed in each arm to detect a 50% reduction in preterm birth rate with vaginal progesterone, with 80% power and 2-sided alpha of 0.05. The primary outcome was preterm birth at <37 weeks of gestation. Prespecified secondary outcomes included preterm birth at <34 and <28 weeks of gestation, mean gestational age at delivery, neonatal morbidity and mortality, and measures of adherence. Analysis was by intention to treat. The chi-square test and Student t test were used as appropriate. P<.05 was considered significant.
RESULTS


Overall, 205 participants were randomized; 94 participants in the vaginal progesterone group and 94 participants in 17-hydroxyprogesterone caproate group were included. Although gestational age at enrollment was similar, those assigned to vaginal progesterone initiated therapy earlier (16.9±1.4 vs 17.8±2.5 weeks; P=.001). Overall continuation of assigned formulation until delivery was similar (73% vs 69%; P=.61). There was no significant difference in preterm birth at <37 (31% vs 38%; P=.28; relative risk, 0.81 [95% confidence interval, 0.54-1.20]), <34 (9.6% vs 14.9%; P=.26; relative risk, 0.64 [95% confidence interval, 0.29-1.41]), or <28 (1.1% vs 4.3%; P=.37; relative risk, 0.25 [95% confidence interval, 0.03-2.20]) weeks of gestation. Participants in the vaginal progesterone group had a later mean gestational age at delivery than participants in the 17-hydroxyprogesterone caproate group (37.36±2.72 vs 36.34±4.10 weeks; mean difference, 1.02 [95% confidence interval, 0.01-2.01]; P=.047).
CONCLUSION


Vaginal progesterone did not reduce the risk of recurrent preterm birth by 50% compared with 17-OHPC; however, vaginal progesterone may lead to increased latency to delivery. This trial was underpowered to detect a smaller, but still clinically significant, difference in the efficacy of preterm birth prevention. Patient factors that impact adherence and ability to obtain medication in a timely fashion should be included in counseling on progesterone selection.",2022,"There was no significant difference in PTB<37wks (31% vs 38%, p=0.28, RR 0.81 (0.54-1.20)), <34 weeks (9.6% vs 14.9%, p=0.26, RR 0.64 (0.29-1.41)), or <28 weeks (1.1% vs 4.3%, p=0.37, RR 0.25 (0.03-2.20)).","['recurrent preterm birth (PTB) in singletons with prior spontaneous preterm birth (sPTB', '205 participants were randomized; n=94 in vaginal progesterone and n=94 in 17OHPC were included', ""five United States centers of singleton pregnancies <24 weeks' with a prior sPTB"", 'recurrent preterm birth (VIP']","['vaginal progesterone', 'Vaginal progesterone versus Intramuscular 17-hydroxyprogesterone caproate', 'progesterone formulation', 'vaginal progesterone suppository nightly or 250mg intramuscular 17OHPC']","['later mean gestational age at delivery than 17OHPC', 'recurrent PTB rate', 'mean gestational age at delivery, neonatal morbidity/mortality, and measures of adherence', 'risk of recurrent preterm birth', 'PTB<37wks', 'PTB rate']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042395', 'cui_str': 'vasoactive intestinal peptide'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C0006924', 'cui_str': 'Hexanoates'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",205.0,0.456989,"There was no significant difference in PTB<37wks (31% vs 38%, p=0.28, RR 0.81 (0.54-1.20)), <34 weeks (9.6% vs 14.9%, p=0.26, RR 0.64 (0.29-1.41)), or <28 weeks (1.1% vs 4.3%, p=0.37, RR 0.25 (0.03-2.20)).","[{'ForeName': 'Rupsa C', 'Initials': 'RC', 'LastName': 'Boelig', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA. Electronic address: Rupsa.boelig@jefferson.edu.'}, {'ForeName': 'Corina N', 'Initials': 'CN', 'LastName': 'Schoen', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, UMass Chan Medical School-Baystate Health, Worcester, MA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Frey', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH.'}, {'ForeName': 'Alexis C', 'Initials': 'AC', 'LastName': 'Gimovsky', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, School of Medicine and Health Sciences, George Washington University, Washington, DC.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Springel', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Backley', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, UMass Chan Medical School-Baystate Health, Worcester, MA.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Berghella', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2022.02.012']
474,35191654,Radial shock-wave therapy for frozen shoulder patients with type 2 diabetes mellitus: a pilot trial comparing two different energy levels.,"BACKGROUND


Extracorporeal shock-wave therapy (ESWT) is highly recommended for the management of orthopedic shoulder pathologies. Yet, the clinical relevance of the dose difference effect of radial ESWT approaches in the management of frozen shoulder patients with type 2 diabetes mellitus remains uncertain.
AIM


The aim was to examine the short-term effects of medium-and high-energy levels of radial ESWT (rESWT) in the treatment of frozen shoulder patients with type 2 diabetes mellitus.
DESIGN


Prospective clinical pilot study.
SETTING


This study was conducted in an outpatient clinic.
POPULATION


Thirty-nine patients who had frozen shoulder untreated for at least 3 months, diagnosed with type 2 diabetes mellitus for ≥3 years were included.
METHODS


The patients were randomly allocated to receive either high-energy rESWT (hrESWT), or medium-energy rESWT (mrESWT) or placebo at 8 Hz twice a week for six weeks. The primary outcome measure was pain, evaluated by the Visual Analog Scale (VAS) Score. Secondary outcome measures were function evaluated by the Shoulder Pain and Disability Index (SPADI) Score, and shoulder active range of motion (AROM). The mechanical properties of the deltoid and trapezius muscles were assessed using the MyotonPRO (Myoton AS, Tallinn, Estonia).
RESULTS


The mrESWT resulted in statistically significant reductions in night pain at 6 weeks (η<inf>p</inf> 2 =0.27, P=0.003). Significantly improved function (SPADI scores: -35.42±21.29 vs.-29.59±22.60; η<inf>p</inf> 2 =0.39, P˂0.001) was found in both hrESWT and mrESWT group by 6 weeks. Significantly higher mean shoulder AROM values were recorded for external rotation (η<inf>p</inf> 2 =0.53, P<0.001), and internal rotation (η<inf>p</inf> 2 =0.21, P=0.020), in the hrESWT group at the 6 th  week. A significantly improved resting tone (η<inf>p</inf> 2 =0.58) and stiffness of deltoid muscle (η<inf>p</inf> 2 =0.62) were found in the mrESWT group (P<0.001). The trapezius muscle resting tone reduced with hrESWT (η<inf>p</inf> 2 =0.17, P=0.033).
CONCLUSIONS


Regardless of the energy levels, rESWT appears to be an effective therapeutic intervention for frozen shoulder patients with type 2 diabetes mellitus in the short-term results.
CLINICAL REHABILITATION IMPACT


Our results suggest that this rESWT can be a useful strategy for the rehabilitation of frozen shoulder patients with type 2 diabetes mellitus. This is the first study on dose difference effectiveness in terms of the clinical significance of rESWT which is key to transfer research evidence into practice.",2022,"The mrESWT resulted in statistically significant reductions in night pain at 6 weeks (ηp 2=0.27, p=0.003).","['frozen shoulder patients with type 2 diabetes mellitus', 'Outpatient', 'Thirty-nine patients who had frozen shoulder untreated for at least 3 months, diagnosed with type 2 diabetes mellitus for≥3 years were included']","['placebo', 'rESWT', 'medium-and high-energy levels of radial ESWT (rESWT', 'Radial shock-wave therapy', 'Extracorporeal shock-wave therapy (ESWT', 'radial ESWT approaches', 'high-energy rESWT (hrESWT), or medium-energy rESWT']","['pain, evaluated by the Visual Analog Scale (VAS) score', 'resting tone', 'night pain', 'mean shoulder AROM values', 'function (SPADI scores', 'trapezius muscle resting tone', 'stiffness of deltoid muscle', 'function evaluated by the Shoulder Pain and Disability Index (SPADI) score, and shoulder active range of motion (AROM']","[{'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234255', 'cui_str': 'Night pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}]",39.0,0.0126595,"The mrESWT resulted in statistically significant reductions in night pain at 6 weeks (ηp 2=0.27, p=0.003).","[{'ForeName': 'Tülay Ç', 'Initials': 'TÇ', 'LastName': 'Saldiran', 'Affiliation': 'School of Health Sciences, Department of Physiotherapy and Rehabilitation, Bitlis Eren University, Bitlis, Turkey - tlyfztcvk@gmail.com.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Yazgan', 'Affiliation': 'Department of Physical Therapy and Medicine, Faculty of Medicine, Istanbul Okan University, Istanbul, Turkey.'}, {'ForeName': 'Ahmet C', 'Initials': 'AC', 'LastName': 'Akgöl', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Okan University, Istanbul, Turkey.'}, {'ForeName': 'Fatma K', 'Initials': 'FK', 'LastName': 'Mutluay', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medipol University, Istanbul, Turkey.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.22.07087-3']
475,35191525,The efficacy and optimal matching of an Internet-based acceptance and commitment therapy intervention for depressive symptoms among university students: A randomized controlled trial in China.,"OBJECTIVE


The present study tested the efficacy of an unguided internet-based Acceptance and Commitment Therapy (iACT) program for depression, and identified the psychological characteristics of participants who benefitted the most from the program.
METHOD


Undergraduate students with mild to severe symptoms of depression were randomized to the iACT group (n = 95) or the waiting-list group (WLC group; n = 87). Depressive symptoms and positive mental health were assessed at baseline (T 0  ), at the end of the 6-week program (T 1  ), and at a 3-month follow-up (T 2  ).
RESULTS


Compared with the WLC group, the iACT group showed significantly more improvement in depressive symptoms (d = 1.27) and positive mental health (d = 0.59), both at T 1  and T 2  . Latent Profile Analysis identified three classes of participants: Sensitive-to-Relationship, Low-Reactive-Depression, and Endogenous-Depression group. In general, the treatment was particularly suitable for the Sensitive-to-Relationship class.
CONCLUSION


The iACT was effective in treating the depressive symptoms of undergraduates, especially suitable for the clients with high baseline depression, high externality, high resistance, and high sensitivity to relationships.",2022,"The iACT was effective in treating the depressive symptoms of undergraduates, especially suitable for the clients with high baseline depression, high externality, high resistance, and high sensitivity to relationships.","['Undergraduate students with mild to severe symptoms of depression', 'participants who benefitted the most from the program', 'depressive symptoms among university students']","['waiting-list group (WLC group; n\u2009=\u200987', 'WLC', 'Internet-based acceptance and commitment therapy intervention', 'unguided internet-based Acceptance and Commitment Therapy (iACT) program', 'iACT']","['Depressive symptoms and positive mental health', 'depressive symptoms', 'positive mental health']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0418336,"The iACT was effective in treating the depressive symptoms of undergraduates, especially suitable for the clients with high baseline depression, high externality, high resistance, and high sensitivity to relationships.","[{'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Wampold', 'Affiliation': 'Modum Bad Psychiatric Center, Vikersund, Norway.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Guangrong', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan, China.'}]",Journal of clinical psychology,['10.1002/jclp.23329']
476,35183892,The effect of prostacyclin infusion on markers of endothelial activation and damage in mechanically ventilated patients with SARS-CoV-2 infection.,"BACKGROUND


In a pilot study, we found a significant reduction in mean daily sequential organ failure assessment score in mechanically ventilated patients with COVID-19 who received prostacyclin, compared to placebo. We here investigate the effect on biomarkers of endothelial activation and damage.
METHODS


Post-hoc study of a randomized controlled trial in adult patients with confirmed SARS-CoV-2 infection, mechanically ventilated, with soluble thrombomodulin (sTM) plasma levels >4 ng/mL. Patients received prostacyclin infusion (1 ng/kg/min) or placebo. Blood samples were collected at baseline and 24 h.
RESULTS


Eighty patients were randomized (41 prostacyclin, 39 placebo). The median changes in syndecan-1 plasma levels at 24 h were -3.95 (IQR: -21.1 to 2.71) ng/mL in the prostacyclin group vs. 3.06 (IQR: -8.73 to 20.5) ng/mL in the placebo group (difference of the medians: -7.01 [95% CI: -22.3 to -0.231] ng/mL, corresponding to -3% [95% CI: -11% to 0%], p = 0.04). Changes in plasma levels of sTM, PECAM-1, p-selectin, and CD40L did not differ significantly between groups.
CONCLUSIONS


Prostacyclin infusion, compared to placebo, resulted in a measurable decrease in endothelial glycocalyx shedding (syndecan-1) at 24 h, suggesting a protective effect on the endothelium, which may be related to the observed reduction in organ failure.",2022,"Changes in plasma levels of sTM, PECAM-1, p-selectin, and CD40L did not differ significantly between groups.
","['mechanically ventilated patients with SARS-CoV-2 infection', 'mechanically ventilated patients with COVID-19 who received', 'adult patients with confirmed SARS-CoV-2 infection, mechanically ventilated, with soluble thrombomodulin (sTM) plasma levels >4 ng/mL. Patients received', 'Eighty patients']","['placebo', 'Prostacyclin infusion', 'prostacyclin infusion (1 ng/kg/min) or placebo', 'prostacyclin', 'prostacyclin infusion']","['mean daily sequential organ failure assessment score', 'endothelial glycocalyx shedding (syndecan-1', 'Blood samples', 'median changes in syndecan-1 plasma levels', 'plasma levels of sTM, PECAM-1, p-selectin, and CD40L', 'endothelial activation and damage']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033567', 'cui_str': 'Epoprostenol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1320753', 'cui_str': 'ng/kg/min'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0081939', 'cui_str': 'Lymphocyte antigen CD31'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0167627', 'cui_str': 'Lymphocyte antigen CD154'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",80.0,0.353238,"Changes in plasma levels of sTM, PECAM-1, p-selectin, and CD40L did not differ significantly between groups.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Vigstedt', 'Affiliation': 'Department of Clinical Immunology, Rigshospitalet, Copenhagen, Denmark. Electronic address: martin.vigstedt@regionh.dk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Søe-Jensen', 'Affiliation': 'Department of Intensive Care, Herlev Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital - North Zealand, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels E', 'Initials': 'NE', 'LastName': 'Clausen', 'Affiliation': 'Department of Intensive Care, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Klaus T', 'Initials': 'KT', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Intensive Care, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Biostatistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stensballe', 'Affiliation': 'Department of Clinical Immunology, Rigshospitalet, Copenhagen, Denmark; Department of Anaesthesiology, Center of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pär I', 'Initials': 'PI', 'LastName': 'Johansson', 'Affiliation': 'Department of Clinical Immunology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of critical care,['10.1016/j.jcrc.2022.154010']
477,35187687,The effect of peripheral defocus on axial growth and modulation of refractive error in hyperopes.,"PURPOSE


To establish whether axial growth and refractive error can be modulated in hyperopic children by imposing relative peripheral hyperopic defocus using multifocal soft contact lenses.
METHODS


A prospective controlled study with hyperopic participants allocated to a control or test group. Control group participants were corrected with single vision spectacles and changes to axial length and refractive error were followed for 3 years. For the test group, axial growth and post-cycloplegic refractive error were observed with participants wearing single vision spectacles for the first 6 months of the trial and then corrected with centre-near multifocal soft contact lenses with a 2.00 D add for 2 years. The central 'near' portion of the contact lens corrected distance refractive error while the 'distance' portion imposed hyperopic defocus. Participants reverted to single vision spectacles for the final 6 months of the study.
RESULTS


Twenty-two participants, mean age 11.13 years (SD 1.72) (range 8.33-13.92), completed the trial. Axial length did not change during the first 6 months in either group (p = 1.00). Axial growth across the 2-year intervention period was 0.17 mm (SEM 0.04) (p < 0.0005) in the test group versus 0.06 mm (SEM 0.07) (p = 0.68) in the control group. Axial length was invariant during the final 6 months in either group (p = 1.00). Refractive error was stable during the first 6 months in both groups (p = 1.00). Refractive error change across the 2-year intervention period was -0.26 D (SEM 0.14) (p = 0.38) in the test group versus -0.01 D (SEM 0.09) (p = 1.00) in the control group. Neither the test (p = 1.00) nor control (p = 0.63) group demonstrated a change in refractive error during the final 6 months.
CONCLUSIONS


The rate of axial growth can be accelerated in children with hyperopia using centre-near multifocal soft contact lenses.",2022,"Neither the test (p = 1.00) nor control (p = 0.63) group demonstrated a change in refractive error during the final 6 months.
","['hyperopic children', 'children with hyperopia using centre-near multifocal soft contact lenses', 'Twenty-two participants, mean age 11.13\xa0years (SD 1.72) (range 8.33-13.92), completed the trial', 'hyperopes']",[],"['axial growth and modulation of refractive error', 'rate of axial growth', 'Axial length', 'Refractive error change', 'refractive error', 'single vision spectacles', 'Refractive error', 'Axial growth', 'single vision spectacles and changes to axial length and refractive error']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020490', 'cui_str': 'Hypermetropia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0009838', 'cui_str': 'Hydrophilic contact lens'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517513', 'cui_str': '1.72'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1275648', 'cui_str': 'Single vision glasses'}]",22.0,0.132625,"Neither the test (p = 1.00) nor control (p = 0.63) group demonstrated a change in refractive error during the final 6 months.
","[{'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Beasley', 'Affiliation': 'School of Optometry, Aston University, Birmingham, UK.'}, {'ForeName': 'Leon N', 'Initials': 'LN', 'LastName': 'Davies', 'Affiliation': 'School of Optometry, Aston University, Birmingham, UK.'}, {'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Logan', 'Affiliation': 'School of Optometry, Aston University, Birmingham, UK.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12951']
478,35183790,Effects of image-guided adaptive radiotherapy combined with hepatic artery chemoembolization in primary liver cancer patients.,"OBJECTIVE


The study aimed to explore the effects of image-guided adaptive radiotherapy combined with hepatic artery chemoembolization on the immune function of primary liver cancer patients.
METHODS


The study included 84 primary liver cancer patients who received treatment at our hospital between April 2018 and January 2020. They were divided into the control group (n=42, hepatic artery chemoembolization) and the study group (n=42, image-guided adaptive radiotherapy combined with hepatic artery chemoembolization) using the random number table method. AFP, ALT, AST, CA724, CA242 and immune function before and after treatment were compared in the two groups and the short-term efficacy and adverse events (AEs) were statistically analyzed. The two groups were followed up.
RESULTS


After treatment, the study group had a higher ORR and DCR compared to the control group, and the difference was statistically significant (P < 0.05). There was no statistical difference in the levels of AFP, ALT, AST, CA724 and CA242 between the two groups before treatment (P > 05). After treatment, the study group had lower levels of AFP, ALT, AST, CA724 and CA242 than the control group, and the difference was statistically significant (P < 0.05). There was no statistical difference in the levels of CD4 + , CD8 + , and CD4 + /CD8 +  before treatment in the two groups (P > 05). After treatment, the study group had higher levels of CD4 +  and CD4 + /CD8 +  but lower levels of CD8 +  compared to the control group, and the difference was statistically significant (P < 0.05). In the study group, 2 patients developed radiation-induced liver disease, and the incidence was 4.76% (2/42), which occurred at 4 and 6 weeks after the end of radiotherapy, respectively. The patients mainly had elevated transaminases, ascites, and liver enlargement and hepatoprotection and nutritional support were provided, and the patients gradually recovered after treatment. There was no statistical difference in the incidence of AEs between the two groups (p > 0.05). All patients in the study completed follow up and the follow up completion rate was 100%. The median duration of follow up was 22.5 months. In the study group, 12 of 42 patients (28.57%) died and 21 cases (50.00%) had recurrence. In the control group, 21 of 42 cases (50.00%) died and 27 cases (64.29%) recurred. At 1 year, there was no statistical difference in ORR and DCR between the two groups (P > 0.05) and at 2 years, the study group had a higher ORR and DCR than the control group, and the difference was statistically significant (P < 0.05).
CONCLUSION


Image-guided adaptive radiotherapy combined with hepatic artery chemoembolization may improve the immune function of primary liver cancer patients and is of important clinical application value.",2022,"After treatment, the study group had lower levels of AFP, ALT, AST, CA724 and CA242 than the control group, and the difference was statistically significant (p<0.05).","['84 primary liver cancer patients who received treatment at our hospital between April 2018 and January 2020', 'primary liver cancer patients']","['hepatic artery chemoembolization', 'Image-guided adaptive radiotherapy combined with hepatic artery chemoembolization', 'image-guided adaptive radiotherapy combined with hepatic artery chemoembolization']","['lower levels of AFP, ALT, AST, CA724 and CA242', 'radiation-induced liver disease', 'higher levels of CD4 +  and CD4 + /CD8 +  but lower levels of CD8 ', 'elevated transaminases, ascites, and liver enlargement and hepatoprotection and nutritional support', 'AFP, ALT, AST, CA724, CA242 and immune function', 'levels of AFP, ALT, AST, CA724 and CA242', 'ORR and DCR', 'recurrence', 'median duration', 'incidence of AEs', 'levels of CD4 + , CD8 + , and CD4 + /CD8 ']","[{'cui': 'C0024620', 'cui_str': 'Primary malignant neoplasm of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0019145', 'cui_str': 'Hepatic artery'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0920160', 'cui_str': 'Radiation-induced liver disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0438717', 'cui_str': 'Transaminases increased'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0019209', 'cui_str': 'Large liver'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",84.0,0.0279512,"After treatment, the study group had lower levels of AFP, ALT, AST, CA724 and CA242 than the control group, and the difference was statistically significant (p<0.05).","[{'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China.'}, {'ForeName': 'Changwang', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China.'}, {'ForeName': 'Changwen', 'Initials': 'C', 'LastName': 'Bo', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China.'}, {'ForeName': 'Changpeng', 'Initials': 'C', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China.'}, {'ForeName': 'Sujing', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, No.89 Donggang Road, Yuhua District, Shijiazhuang 050031, China. Electronic address: 123959555@qq.com.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2022.101889']
479,35552080,Effects of acupressure and shower applied in the delivery on the intensity of labor pain and postpartum comfort.,"BACKGROUND AND PURPOSE


Labour pain is a constantly increasing pain. This study thus aims to determine the effects of acupressure and shower on labour pain and postpartum comfort.
METHODS


In this randomized controlled trial (RCT), the control group consisted of 40 pregnant women, while the experimental groups consisted of 80 pregnant women in total. The experimental groups received routine labour care and either acupressure or showers upon reaching three cervical dilations (4-5, 6-7 and 8-10 cm). The control group only received routine labour care. A maternal information form (MIF), the Visual Analog Scale (VAS) and the Postpartum Comfort Questionnaire (PPCQ) were used to collect data.
RESULTS


Pain was significantly reduced in both of the experimental groups, in contrast to the control group, in all periods of the study (p < 0.001). Postpartum comfort also significantly increased in the experimental groups compared to the control group (p < 0.05).
CONCLUSION


Acupressure and showering are effective in reducing labour pain and increasing postpartum comfort. Midwives and nurses can therefore apply them as inexpensive and easy to administer methods for labour pain relief.",2022,"RESULTS


Pain was significantly reduced in both of the experimental groups, in contrast to the control group, in all periods of the study (p < 0.001).","['40 pregnant women', '80 pregnant women in total']","['routine labour care', 'acupressure', 'routine labour care and either acupressure or showers upon reaching three cervical dilations']","['Pain', 'labour pain', 'Postpartum comfort', 'intensity of labor pain and postpartum comfort', 'Visual Analog Scale (VAS) and the Postpartum Comfort Questionnaire (PPCQ', 'labour pain and postpartum comfort']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0541748', 'cui_str': 'Shower'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",80.0,0.0454037,"RESULTS


Pain was significantly reduced in both of the experimental groups, in contrast to the control group, in all periods of the study (p < 0.001).","[{'ForeName': 'Ayça', 'Initials': 'A', 'LastName': 'Solt Kirca', 'Affiliation': 'Kirklareli University School of Health, Midwifery Department Kirklareli, Turkey. Electronic address: aycasolt@klu.edu.tr.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Kanza Gul', 'Affiliation': 'Private Medipol Nisa Hospital, Istanbul, Turkey. Electronic address: deryakanza@yahoo.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2022.04.018']
480,35194193,The impact of anthracyclines in intermediate and high-risk HER2-negative early breast cancer-a pooled analysis of the randomised clinical trials PlanB and SUCCESS C.,"BACKGROUND


Anthracycline/cyclophosphamide-taxane-containing chemotherapy (AC-T) is the standard of care in the adjuvant treatment of HER2-negative early breast cancer (EBC), but recent studies suggest omission of anthracyclines for reduced toxicity without compromising efficacy.
METHODS


Based on individual patient data (n = 5924) pooled from the randomised Phase III trials PlanB and SUCCESS C, we compared disease-free survival (DFS) and overall survival (OS) between intermediate to high-risk HER2-negative EBC-patients treated with either six cycles of docetaxel/cyclophosphamide (TC6) or an AC-T regime using univariable and adjusted multivariable Cox regression models.
RESULTS


AC-T conferred no significant DFS or OS advantage in univariable (DFS: hazard ratio (HR) for TC vs. AT 1.05, 95% confidence interval (CI): 0.89-1.24, P = 0.57; OS: HR 1.00, 95% CI: 0.80-1.26, P = 1.00) and adjusted multivariable analysis (DFS: HR 1.01, 95% CI: 0.86-1.19, P = 0.91; OS: HR 0.97, 95% CI: 0.77-1.22, P = 0.79). Patients receiving TC6 had significantly fewer grade 3-4 adverse events. Exploratory subgroup analysis showed that AC-T was associated with significantly better DFS and OS in pN2/3 patients, specifically in those with lobular histology.
CONCLUSION


For most patients with HER2-negative EBC, AC-T is not associated with a survival benefit compared to TC6. However, patients with lobular pN2/pN3 tumours seem to benefit from anthracycline-containing chemotherapy.",2022,"Exploratory subgroup analysis showed that AC-T was associated with significantly better DFS and OS in pN2/3 patients, specifically in those with lobular histology.
","['HER2-negative early breast cancer (EBC', 'patients with HER2-negative EBC', 'patients with lobular pN2/pN3 tumours', 'Based on individual patient data (n\u2009=\u20095924']","['anthracyclines', 'Anthracycline/cyclophosphamide-taxane-containing chemotherapy (AC-T', 'docetaxel/cyclophosphamide (TC6', 'TC6', 'anthracycline-containing chemotherapy']","['disease-free survival (DFS) and overall survival (OS', 'grade 3-4 adverse events', 'DFS or OS advantage']","[{'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.308304,"Exploratory subgroup analysis showed that AC-T was associated with significantly better DFS and OS in pN2/3 patients, specifically in those with lobular histology.
","[{'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany. amelie.degregorio@uni-ulm.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Thomas W P', 'Initials': 'TWP', 'LastName': 'Friedl', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Nitz', 'Affiliation': 'Department of Gynecology and Obstetrics, Evangelical Hospital Bethesda, Moenchengladbach, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Rack', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Kates', 'Affiliation': 'Westdeutsche Studiengruppe (WSG), Moenchengladbach, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Fehm', 'Affiliation': 'Department of Gynecology and Obstetrics, Duesseldorf University Hospital, Heinrich-Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kreipe', 'Affiliation': 'Institute of Pathology, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Christgen', 'Affiliation': 'Institute of Pathology, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Westdeutsche Studiengruppe (WSG), Moenchengladbach, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Trapp', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Graz, Graz, Austria.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wuerstlein', 'Affiliation': 'Westdeutsche Studiengruppe (WSG), Moenchengladbach, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hartkopf', 'Affiliation': 'Department of Gynecology and Obstetrics, Tuebingen University Hospital, Tuebingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Clemens', 'Affiliation': 'Mutterhaus der Borromaerinnen, Trier, Germany.'}, {'ForeName': 'Toralf', 'Initials': 'T', 'LastName': 'Reimer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Häberle', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Gluz', 'Affiliation': 'Department of Gynecology and Obstetrics, Evangelical Hospital Bethesda, Moenchengladbach, Germany.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Westdeutsche Studiengruppe (WSG), Moenchengladbach, Germany.'}]",British journal of cancer,['10.1038/s41416-021-01690-6']
481,35191639,Bilateral lumbar ultrasound-guided erector spinae plane block versus local anesthetic infiltration for perioperative analgesia in lumbar spine surgery: a randomized controlled trial.,"BACKGROUND


Lumbar spinal surgery is associated with severe postoperative pain. We examined the analgesic efficacy of bilateral lumbar ultrasound-guided erector spinae plane block (ESPB) with ropivacaine compared with local infiltration.
METHODS


Patients undergoing elective lumbar arthrodesis were randomly divided into two groups. Control group received 0.375% ropivacaine 40 mL through the wound, and ESPB group received preoperative bilateral ESPB with 0.375% ropivacaine 40 mL. Primary outcome was postoperative pain intensity at rest using a Numeric Rating Scale (NRS). Secondary outcomes included difference in pain intensity between preintervention and defined timepoints, total amount of opioid analgesic requested by the patients at the same timepoints, the incidence of any adverse event, and the length of hospital stay (LOS) after surgery.
RESULTS


Sixty patients were enrolled in the study. After surgery we detected a NRS value of 1.9±1.5 in ESPB group and 5.9±1.6 in control group (P<0.001). About the opioid consumption we found a total sufentanil tablets consumption of 17±6 and 10±3 at 48 hours for control group and ESPB group, respectively (P<0.001). Concerning LOS, 30 (100%) patients in the control group and 22 (73.3%) in ESPB group were discharged after 72 hours (P=0.005).
CONCLUSIONS


Bilateral ultrasound-guided ESPB offers improved postoperative analgesia compared with local infiltration in patients undergoing lumbar spinal surgery.",2022,"Concerning LOS, 30 (100%) patients in the control group and 22(73.3%) in ESPB group were discharged after 72 hours (p=0.005).
","['lumbar spine surgery', 'patients undergoing lumbar spinal surgery', 'Patients undergoing elective lumbar arthrodesis', 'Sixty patients were enrolled in the study']","['Bilateral lumbar ultrasound-guided erector spinae plane block versus local anaesthetic infiltration', 'ropivacaine', 'bilateral lumbar ultrasound-guided erector spinae plane block (ESPB', 'Bilateral ultrasound-guided ESPB', 'preoperative bilateral ESPB with 0.375 % ropivacaine', 'ESPB']","['pain intensity between pre-intervention and defined timepoints, total amount of opioid analgesic requested by the patients at the same timepoints, the incidence of any adverse event, and the length of hospital stay (LOS', 'postoperative pain intensity at rest using a Numeric Rating Scale (NRS', 'postoperative analgesia', 'analgesic efficacy']","[{'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4517455', 'cui_str': '0.375'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.222231,"Concerning LOS, 30 (100%) patients in the control group and 22(73.3%) in ESPB group were discharged after 72 hours (p=0.005).
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Vergari', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Emergency Medicine, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy - alessandro.vergari@policlinicogemelli.it.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Frassanito', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Emergency Medicine, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'DI Muro', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Emergency Medicine, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Nestorini', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Emergency Medicine, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Chierichini', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Emergency Medicine, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Emergency Medicine, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'DI Stasio', 'Affiliation': 'Sacred Heart Catholic University, Rome, Italy.'}]",Minerva anestesiologica,['10.23736/S0375-9393.22.15950-X']
482,35195544,Idiopathic Intracranial Hypertension: Incidental Discovery Versus Symptomatic Presentation.,"BACKGROUND


We aim to compare the clinical characteristics, disease course and visual outcomes between Canadian patients with idiopathic intracranial hypertension (IIH) who were incidentally discovered and those who sought care due to symptoms of IIH.
METHODS


Retrospective chart review of consecutive IIH patients conducted at tertiary neuro-ophthalmology clinics. Patients were divided into Group 1 (incidentally discovered disease) and Group 2 (patients seeking medical care due to symptoms of intracranial hypertension).
RESULTS


One hundred eighty-six patients were included in the study; of which, 75 (40.3%; Group-1) were incidentally discovered and 111 presented due to symptoms of IIH (Group-2). There were no differences in proportion of females (P = 0.101), age (P = 0.450), body mass index (P = 0.386), MRI findings of empty or partially empty sella (P = 0.41), and sella grade (P = 0.704). Group-1 patients were less likely to have experienced headache (P = 0.001), transient visual obscurations (P < 0.001), and diplopia (P = 0.026) at presentation. Group-1 patients were less likely to receive medical (P < 0.001) and surgical (P = 0.004) treatment. There was no difference in proportion of patients who lost weight between the groups (P = 0.848). At baseline, Group-1 patients exhibited better visual acuity (P = 0.001), Humphrey mean deviation (P < 0.001) and retinal nerve fiber layer thickness (P < 0.001). Group-1 patients continued to have better visual acuity (P = 0.002) and Humphrey mean deviation (P < 0.001) at final follow-up.
CONCLUSIONS


A significant portion of IIH patients were incidentally discovered. This group exhibited a favorable prognosis and only a minority of these patients required treatment. The way in which patients enter the medical system may be a valuable way to risk stratify IIH patients.",2022,"Group-1 patients were less likely to have experienced headache (P = 0.001), transient visual obscurations (P < 0.001), and diplopia (P = 0.026) at presentation.","['Patients were divided into Group 1 (incidentally discovered disease) and Group 2 (patients seeking medical care due to symptoms of intracranial hypertension', 'Canadian patients with idiopathic intracranial hypertension (IIH) who were incidentally discovered and those who sought care due to symptoms of IIH', 'One hundred eighty-six patients were included in the study; of which, 75 (40.3%; Group-1) were incidentally discovered and 111 presented due to symptoms of IIH (Group-2', 'Idiopathic Intracranial Hypertension', 'consecutive IIH patients conducted at tertiary neuro-ophthalmology clinics']",[],"['MRI findings of empty or partially empty sella', 'proportion of patients who lost weight', 'body mass index', 'Humphrey mean deviation', 'retinal nerve fiber layer thickness', 'headache', 'transient visual obscurations', 'proportion of females', 'visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0033845', 'cui_str': 'Benign intracranial hypertension'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C3838844', 'cui_str': 'Ophthalmology clinic'}]",[],"[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0014008', 'cui_str': 'Empty sella syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C1321318', 'cui_str': 'Visual obscuration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",186.0,0.050878,"Group-1 patients were less likely to have experienced headache (P = 0.001), transient visual obscurations (P < 0.001), and diplopia (P = 0.026) at presentation.","[{'ForeName': 'Amir R', 'Initials': 'AR', 'LastName': 'Vosoughi', 'Affiliation': 'Max Rady College of Medicine (ARV), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Ophthalmology and Vision Sciences (EAM JAM), University of Toronto, Toronto, Canada; Division of Neurology (EAM Department of Medicine, University of Toronto, Canada; and Kensington Vision and Research Centre (JAM), Toronto, Canada.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Margolin', 'Affiliation': ''}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Micieli', 'Affiliation': ''}]",Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000001475']
483,35196064,Implementation of a Multisite Financial Reimbursement Program in Cancer Clinical Trials Integrated With Patient Navigation: A Pilot Randomized Clinical Trial.,"PURPOSE


Cancer clinical trial participants face considerable indirect costs associated with participation, such as travel and lodging, which may contribute to poor enrollment. Here, we report the findings in IMproving Patient Access to Cancer clinical Trials, a pilot feasibility study investigating the efficacy of offering a financial reimbursement program (FRP) during a therapeutic clinical trial discussion with or without additional outreach in improving patient enrollment.
METHODS


Study participants for this study were recruited at two National Cancer Institute-designated comprehensive cancer centers (CCCs) from April 8, 2019, to September 19, 2019. Eligible participants were adults with a cancer diagnosis being approached to consider enrollment in a clinical trial. Participants were randomly assigned 1:1 to receive no follow-up (usual care) or a follow-up telephone call to facilitate FRP utilization stratified by study site. The target enrollment was 132 patients, with 66 patients in each study arm. The primary outcome was the consent rate to the multisite interventional study on the FRP among participants enrolling in clinical trials.
RESULTS


The study had a 78% consent rate and enrolled a total of 132 participants, of whom 51% were non-White compared with 28% of CCC treatment clinical trial participants in 2019. No difference in enrollment in clinical trials between the two study arms was observed as the proportion of enrollment was 70% for both study arms. The most common reason for not enrolling in a clinical trial was due to ineligibility determined through screening procedures (75%).
CONCLUSION


The current study observed that implementation of FRP at CCCs is feasible and serves a diverse patient population. Future studies will measure the impact of programs on overall clinical trial accrual and among racial/ethnic minorities.",2022,No difference in enrollment in clinical trials between the two study arms was observed as the proportion of enrollment was 70% for both study arms.,"['132 patients, with 66 patients in each study arm', 'The study had a 78% consent rate and enrolled a total of 132 participants, of whom 51% were non-White compared with 28% of CCC treatment clinical trial participants in 2019', 'Study participants for this study were recruited at two National Cancer Institute-designated comprehensive cancer centers (CCCs) from April 8, 2019, to September 19, 2019', 'Eligible participants were adults with a cancer diagnosis being approached to consider enrollment in a clinical trial']","['financial reimbursement program (FRP', 'Multisite Financial Reimbursement Program', 'no follow-up (usual care) or a follow-up telephone call']",['consent rate'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C2711213', 'cui_str': 'Consented'}]",132.0,0.700504,No difference in enrollment in clinical trials between the two study arms was observed as the proportion of enrollment was 70% for both study arms.,"[{'ForeName': 'Hala T', 'Initials': 'HT', 'LastName': 'Borno', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.'}, {'ForeName': 'Tracy K', 'Initials': 'TK', 'LastName': 'Lin', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Skafel', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, San Francisco, CA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Nieves', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Dornsife', 'Affiliation': 'Lazarex Cancer Foundation, Danville, CA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': 'Lazarex Cancer Foundation, Danville, CA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Rhoads', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Small', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Spicer', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Southern California, Los Angeles, CA.'}]",JCO oncology practice,['10.1200/OP.21.00328']
484,35194862,Evaluating the effectiveness of e-cigarettes compared with usual care for smoking cessation when offered to smokers at homeless centres: protocol for a multi-centre cluster-randomized controlled trial in Great Britain.,"BACKGROUND AND AIMS


Smoking is extremely common among adults experiencing homelessness, but there is lack of evidence for treatment efficacy. E-cigarettes are an effective quitting aid, but they have not been widely tested in smokers with complex health and social needs. Here we build upon our cluster feasibility trial and evaluate the offer of an e-cigarette or usual care to smokers accessing a homeless centre.
DESIGN, SETTING AND PARTICIPANTS


Multi-centre two-arm cluster-randomized controlled trial with mixed-method embedded process and economic evaluation in homeless centres in England, Scotland and Wales. Adult smokers (18+ years; n = 480) accessing homeless centres and who are known to centre staff and willing to consent.
INTERVENTION AND COMPARATOR


Clusters (n = 32) will be randomized to either an e-cigarette starter pack with weekly allocations of nicotine containing e-liquid for 4 weeks [choice of flavours (menthol, fruit and tobacco) and strengths 12 mg/ml and 18 mg/ml] or the usual care intervention, which comprises very brief advice and a leaflet signposting to the local stop smoking service.
MEASUREMENTS


The primary outcome is 24-week sustained carbon monoxide-validated smoking cessation (Russell Standard defined, intention-to-treat analysis).
SECONDARY OUTCOMES


(i) 50% smoking reduction (cigarettes per day) from baseline to 24 weeks; (ii) 7-day point prevalence quit rates at 4-, 12- and 24-week follow-up; (iii) changes in risky smoking practices (e.g. sharing cigarettes, smoking discarded cigarettes) from baseline to 4, 12 and 24 weeks; (iv) cost-effectiveness of the intervention; and (v) fidelity of intervention implementation; mechanisms of change; contextual influences and sustainability.
CONCLUSIONS


This is the first study, to our knowledge, to randomly assign smokers experiencing homelessness to an e-cigarette and usual care intervention to measure smoking abstinence with embedded process and economic evaluations. If effective, its results will be used to inform the larger-scale implementation of offering e-cigarettes throughout homeless centres to aid smoking cessation.",2022,"If effective, its results will be used to inform the larger scale implementation of offering e-cigarettes across homeless centres to aid smoking cessation.","['to smokers accessing a homeless centre', 'Adult smokers (18+ years; n= 480) accessing homeless centres and who are known to centre staff and willing to consent', 'adults experiencing homelessness', 'Homeless centres in England, Scotland and Wales', 'smokers at homeless centres']","['e-cigarette or usual care', 'e-cigarettes', 'usual care for smoking cessation', 'nicotine containing e-liquid for 4 weeks (choice of flavours (menthol, fruit and tobacco) and strengths 12 mg/mL and 18mg/mL), or the usual care intervention which comprises very brief advice and a leaflet signposting to the local stop smoking service']","['prevalence quit rates', 'risky smoking practices', '24-week sustained carbon monoxide validated smoking cessation ']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C4543630', 'cui_str': 'Electronic cigarette liquid containing nicotine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0742247,"If effective, its results will be used to inform the larger scale implementation of offering e-cigarettes across homeless centres to aid smoking cessation.","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cox', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bauld', 'Affiliation': 'Spectrum Research Consortium, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Centre for Development, Evaluation, Complexity and Implementation in Public Health Improvement, (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Carlisle', 'Affiliation': 'Centrepoint Soho Ltd, London, UK.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ford', 'Affiliation': 'Institute for Social Marketing and Health, University of Stirling, Stirling, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Notley', 'Affiliation': 'Addiction Research Group, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': 'Spectrum Research Consortium, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Robson', 'Affiliation': 'Spectrum Research Consortium, UK.'}, {'ForeName': 'Kirstie', 'Initials': 'K', 'LastName': 'Soar', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Science, London South Bank University, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Science, London South Bank University, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ward', 'Affiliation': 'Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Dawkins', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Science, London South Bank University, London, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.15851']
485,35195752,Effect of coordinator-based osteoporosis intervention on quality of life in patients with fragility fractures: a prospective randomized trial.,"We examined the effects of the coordinator-based intervention on quality of life (QOL) in the aftermath of a fragility fracture, as well as factors predictive of post-fracture QOL. The coordinator-based interventions mitigated the decrease in QOL. Secondary fracture after primary fracture, however, was a significant predictor of lower QOL.
PURPOSE


This study aimed to determine the effects of the coordinator-based intervention on QOL in the aftermath of a fragility fracture, as well as factors predictive of post-fracture QOL, in an Asian population.
METHODS


Patients with new fractures in the intervention group received the coordinator-based intervention by a designated nurse certified as a coordinator, within 3 months of injury. QOL was evaluated using the Japanese version of the EuroQol 5 Dimension 5 Level (EQ-5D-5L) scale  before the fracture (through patient recollections) and at 0.5, 1, and 2 years after the primary fracture.
RESULTS


Data for 141 patients were analyzed: 70 in the liaison intervention (LI) group and 71 in the non-LI group. Significant intervention effects on QOL were observed at 6 months after the fracture; the QOL score was 0.079 points higher in the LI group than in the non-LI group (p=0.019). Further, the LI group reported significantly less pain/discomfort at 2 years after the fracture, compared to the non-LI group (p=0.037). In addition, secondary fractures were found to significantly prevent improvement and maintenance of QOL during the recovery period (p=0.015).
CONCLUSION


Short-term intervention effects were observable 6 months after the primary fracture, with the LI group mitigated the decrease in QOL. Few patients in the LI group reported pain/discomfort 2 years after the fracture, but there is uncertainty regarding its clinical significance. Secondary fracture after initial injury was a significant predictor of lower QOL after a fracture.",2022,Significant intervention effects on QOL were observed at 6 months after the fracture; the QOL score was 0.079 points higher in the LI group than in the non-LI group (p=0.019).,"['141 patients were analyzed: 70 in the liaison intervention (LI) group and 71 in the non-LI group', 'Patients with new fractures in the intervention group received the', 'patients with fragility fractures']","['coordinator-based osteoporosis intervention', 'coordinator-based intervention']","['QOL', 'QOL score', 'improvement and maintenance of QOL', 'quality of life (QOL', 'quality of life', 'pain/discomfort']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",141.0,0.0185352,Significant intervention effects on QOL were observed at 6 months after the fracture; the QOL score was 0.079 points higher in the LI group than in the non-LI group (p=0.019).,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Okuda', 'Affiliation': 'School of Health Science, Faculty of Medicine, Tottori University, 86 Nishi-Cho, Yonago, Tottori, 683-8503, Japan. reokd@tottori-u.ac.jp.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Osaki', 'Affiliation': 'Rehabilitation Division, Tottori University Hospital, Yonago, Tottori, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Saeki', 'Affiliation': 'Orthopedic Surgery Hospital Ward, Tottori University Hospital, Yonago, Tottori, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Okano', 'Affiliation': 'Department of Orthopedic Surgery, San-in Rosai Hospital, Yonago, Tottori, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tsuda', 'Affiliation': 'Department of Orthopedic Surgery, Saiseikai Sakaiminato General Hospital, Sakaiminato, Tottori, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Department of Orthopedic Surgery, Hakuai Hospital, Yonago, Tottori, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Morio', 'Affiliation': 'Department of Orthopedic Surgery, Misasa Onsen Hospital, Misasa, Tottori, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nagashima', 'Affiliation': 'Department of Orthopedic Surgery, Tottori University, Yonago, Tottori, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagino', 'Affiliation': 'School of Health Science, Faculty of Medicine, Tottori University, 86 Nishi-Cho, Yonago, Tottori, 683-8503, Japan.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-021-06279-6']
486,35196481,Sunbeam Program Reduces Rate of Falls in Long-Term Care Residents With Mild to Moderate Cognitive Impairment or Dementia: Subgroup Analysis of a Cluster Randomized Controlled Trial.,"OBJECTIVES


The Sunbeam trial significantly reduced falls in long-term aged care (LTC) residents. The current study's primary objective was to undertake subgroup analysis of the Sunbeam trial, to determine whether the intervention was effective for reducing falls in LTC residents with mild-moderate cognitive impairment/dementia. Secondary objectives were to determine intervention effects on cognitive and physical function.
DESIGN


Subgroup analysis of a cluster randomized controlled trial (RCT).
SETTING AND PARTICIPANTS


Permanent residents of LTC in Australia who participated in the Sunbeam trial with Addenbrooke's Cognitive Examination-Revised (ACE-R) scores <83 (Mini-Mental State Examination >14 = main trial inclusion criteria).
METHODS


Of 221 participants, 148 had an ACE-R <83 and were included in this study. Sixteen LTC residences (clusters) were randomized to receive either the Sunbeam program or usual care. The Sunbeam program involved two 1-hour sessions/week of tailored and progressive resistance and balance training for 25 weeks followed by a maintenance program (two 30-min sessions/week of nonprogressive exercise for 6 months). Assessments were conducted at baseline, 6 months, and 12 months. Falls were recorded using routinely collected data from the LTC incident management systems.
RESULTS


Rate of falls (50%) and risk of falls (31%), multiple falls (40%), and injurious falls (44%) were reduced in the intervention group. The intervention group had significantly better balance (static and dynamic) and sit-to-stand ability when compared with the control group at 6 months and significantly better dynamic balance at 12 months. There were no serious adverse events.
CONCLUSIONS AND IMPLICATIONS


The Sunbeam Program significantly reduced falls and improved physical performance in cognitively impaired LTC residents. This is a novel and important finding, as many previous studies have excluded people with cognitive impairment/dementia and inconsistent findings have been reported when this population has been studied. Our findings suggest that progressive resistance and balance exercise is a safe and effective fall prevention intervention in LTC residents with mild-moderate cognitive impairment/dementia.",2022,The intervention group had significantly better balance (static and dynamic) and sit-to-stand ability when compared with the control group at 6 months and significantly better dynamic balance at 12 months.,"['cognitively impaired LTC residents', ""Permanent residents of LTC in Australia who participated in the Sunbeam trial with Addenbrooke's Cognitive Examination-Revised (ACE-R) scores <83 (Mini-Mental State Examination "", 'LTC residents with mild-moderate cognitive impairment/dementia', 'Long-Term Care Residents', 'Sixteen LTC residences (clusters', 'long-term aged care (LTC) residents', 'Of 221 participants, 148 had an ACE-R <83 and were included in this study']","['balance exercise', 'Sunbeam Program', 'Sunbeam program or usual care']","['dynamic balance', 'risk of falls', 'Rate of Falls', 'multiple falls', 'physical performance', 'injurious falls', 'cognitive and physical function', 'better balance (static and dynamic) and sit-to-stand ability']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2919447', 'cui_str': ""Addenbrooke's cognitive examination revised""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",221.0,0.0472096,The intervention group had significantly better balance (static and dynamic) and sit-to-stand ability when compared with the control group at 6 months and significantly better dynamic balance at 12 months.,"[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Mak', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, NSW, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Delbaere', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, NSW, Australia; Population Health, Faculty of Medicine, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Refshauge', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Henwood', 'Affiliation': 'University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Goodall', 'Affiliation': 'Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hewitt', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; University Centre for Rural Health, Faculty of Medicine and Health, University of Sydney, Lismore, NSW, Australia.'}, {'ForeName': 'Morag E', 'Initials': 'ME', 'LastName': 'Taylor', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, NSW, Australia; Prince of Wales Clinical School, Faculty of Medicine, UNSW Sydney, Sydney, NSW, Australia. Electronic address: m.taylor@neura.edu.au.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2022.01.064']
487,35201404,Effect of obstructive sleep apnoea on retinal microvascular function: a randomised controlled trial.,"PURPOSE


Retinal microvascular endothelial dysfunction is thought to be of importance in the development of ocular vascular diseases. Obstructive sleep apnoea (OSA) causes macrovascular endothelial dysfunction, but the effect of OSA on retinal microvascular endothelial function is not known. We aimed to determine the effect of OSA on retinal microvascular function.
METHODS


We conducted a multi-centre, double-blind, randomised, parallel, controlled trial in patients with known moderate-to-severe OSA, established on continuous positive airway pressure (CPAP). Participants were randomised to 14 nights of either continued CPAP or sham CPAP to generate a return of OSA. Retinal vascular responses to flickering light were measured using dynamic vessel analysis both at baseline and after 14 nights of intervention. The primary outcome was the change from baseline to follow-up in the area under the curve of the arteriolar response to flickering light, sham CPAP versus continued CPAP.
RESULTS


Nineteen patients were randomised to sham CPAP, and 18 patients were randomised to continued CPAP. There was no significant effect of CPAP withdrawal and return of OSA on retinal responses, with a change in the area under the curve of the arteriole response to flickering light of + 3.8 arbitrary units (95% CI - 10.6 to + 18.2, p = 0.59), sham CPAP versus continued CPAP.
CONCLUSIONS


CPAP withdrawal and a return of OSA had no significant effect on retinal microvascular responses. This contrasts with the effect of CPAP withdrawal on macrovascular endothelial function and suggests that OSA has different effects on macrovascular and microvascular endothelial function. ISRCTN 78082983, 23/10/2014, Prospectively registered.",2022,"There was no significant effect of CPAP withdrawal and return of OSA on retinal responses, with a change in the area under the curve of the arteriole response to flickering light of + 3.8 arbitrary units (95% CI - 10.6 to + 18.2, p = 0.59), sham CPAP versus continued CPAP.
","['Nineteen patients', 'Obstructive sleep apnoea (OSA', 'patients with known moderate-to-severe OSA, established on continuous positive airway pressure (CPAP']","['CPAP', 'OSA', 'obstructive sleep apnoea', 'continued CPAP or sham CPAP', 'sham CPAP', 'CPAP withdrawal']","['macrovascular endothelial function', 'retinal microvascular function', 'retinal microvascular responses', 'macrovascular and microvascular endothelial function', 'change from baseline to follow-up in the area under the curve of the arteriolar response to flickering light, sham CPAP versus continued CPAP', 'CPAP withdrawal and return of OSA on retinal responses']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",19.0,0.304053,"There was no significant effect of CPAP withdrawal and return of OSA on retinal responses, with a change in the area under the curve of the arteriole response to flickering light of + 3.8 arbitrary units (95% CI - 10.6 to + 18.2, p = 0.59), sham CPAP versus continued CPAP.
","[{'ForeName': 'Chris D', 'Initials': 'CD', 'LastName': 'Turnbull', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK. christopher.turnbull@ouh.nhs.uk.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Stockley', 'Affiliation': 'Lung Function & Sleep, Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT, Birmingham, B15 2GW, West Midlands, UK.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Madathil', 'Affiliation': 'Lung Function & Sleep, Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT, Birmingham, B15 2GW, West Midlands, UK.'}, {'ForeName': 'Syed S A', 'Initials': 'SSA', 'LastName': 'Huq', 'Affiliation': 'Lung Function & Sleep, Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT, Birmingham, B15 2GW, West Midlands, UK.'}, {'ForeName': 'Brendan G', 'Initials': 'BG', 'LastName': 'Cooper', 'Affiliation': 'Lung Function & Sleep, Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT, Birmingham, B15 2GW, West Midlands, UK.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Department of Sleep and Respiratory Medicine, University Hospital Coventry and Warwickshire, Coventry, CV2 2DX, Warwickshire, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wharton', 'Affiliation': 'Sleep Department, Heartlands Hospital, University Hospitals Birmingham NHSFT, Birmingham, B15 2GW, West Midlands, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Stradling', 'Affiliation': 'NIHR Biomedical Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebekka', 'Initials': 'R', 'LastName': 'Heitmar', 'Affiliation': 'School of Applied Sciences, Department of Optometry and Vision Sciences, University of Huddersfield, Huddersfield, UK.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-022-05596-8']
488,35199834,DHA Supplementation Attenuates Inflammation-Associated Gene Expression in the Mammary Gland of Lactating Mothers Who Deliver Preterm.,"BACKGROUND


In a randomized trial of DHA supplementation to lactating mothers who delivered preterm, there were significant increases in DHA status in the mother and her infant.
OBJECTIVES


Our objective here was to characterize the mammary gland transcriptomes from the above study. We hypothesized that proinflammatory gene expression would be attenuated in the increased DHA group compared with the standard DHA group.
METHODS


In the original trial, mothers delivering at <29 wk gestation at the University of Cincinnati Medical Center and intending to express their milk were randomly assigned to supplementation with 200 mg/d DHA (standard group: STD) or 1000 mg/d DHA (experimental group: EXP) within 7 d of delivery. Here, we conducted RNA-seq transcriptome analysis of n = 5 EXP and n = 4 STD extracellular mammary mRNA samples extracted from the fat layer of milk samples obtained 4 wk postenrollment. Transcripts were assessed for differential expression (false discovery rate adjusted P value <0.05) and clustering between EXP compared with STD groups. Ontological analysis of all differentially expressed genes (DEGs) was performed with Toppcluster.
RESULTS


There were 409 DEGs. We observed 5 main groups of biological processes that were upregulated, including those associated with improved immune regulation and management of oxidative stress; and 3 main groups of biological processes that were downregulated, including 1 associated with immune dysregulation. For example, we observed upregulation of inflammation-inhibiting genes including NFKB inhibitor alpha (NFKBIA; fold-change (FC), adjusted P value: FC = 1.70, P = 0.007) and interleukin-18 binding protein (IL18BP: FC = 2.2, adjusted P = 0.02); and downregulation of proinflammatory genes including interleukin 7 receptor (IL7R: FC = -1.9, adjusted P = 0.02) and interleukin 1 receptor like 1 (IL1RL1: FC = -13.0, adjusted P = 0.02).
CONCLUSIONS


Increased DHA supplementation during lactation can modulate the expression of inflammation-related genes within the mammary gland. This might translate to milk composition with a more optimal inflammasome profile. Future research with a larger clinical trial and greater interrogation of clinical outcomes is warranted.",2022,"We observed 5 main groups of biological processes that were upregulated, including those associated with improved immune regulation and management of oxidative stress; and 3 main groups of biological processes that were downregulated, including one associated with immune dysregulation.","['lactating mothers who delivered preterm', 'lactating mothers who deliver preterm', 'mothers delivering at <29 weeks gestation at the University of Cincinnati Medical Center and intending to express their milk']","['supplementation with 200 mg/d DHA (STD) or 1000 mg/d DHA (EXP', 'docosahexaenoic acid (DHA) supplementation', 'DHA supplementation']","['IL1RL1', 'DHA status', 'immune regulation and management of oxidative stress']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0566687', 'cui_str': 'Mother delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}]","[{'cui': 'C0212532', 'cui_str': 'IL1RL1 protein, human'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.237295,"We observed 5 main groups of biological processes that were upregulated, including those associated with improved immune regulation and management of oxidative stress; and 3 main groups of biological processes that were downregulated, including one associated with immune dysregulation.","[{'ForeName': 'Joselyn M', 'Initials': 'JM', 'LastName': 'Adams', 'Affiliation': 'Department of Rehabilitation, Exercise, and Nutritional Sciences, University of Cincinnati College of Allied Health Sciences, Cincinnati, OH, USA.'}, {'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Valentine', 'Affiliation': 'Department of Neonatology, Banner University Medical Center, The University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Rebekah A', 'Initials': 'RA', 'LastName': 'Karns', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Lynette K', 'Initials': 'LK', 'LastName': 'Rogers', 'Affiliation': ""Center for Perinatal Research, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Murase', 'Affiliation': 'Department of Neonatology, Showa University Hospital, Shinagawa City, Tokyo, Japan.'}, {'ForeName': 'Grace N', 'Initials': 'GN', 'LastName': 'Fowler', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Nommsen-Rivers', 'Affiliation': 'Department of Rehabilitation, Exercise, and Nutritional Sciences, University of Cincinnati College of Allied Health Sciences, Cincinnati, OH, USA.'}]",The Journal of nutrition,['10.1093/jn/nxac043']
489,35202553,A Randomized Controlled Clinical Trial Exploring Safety and Tolerability of Sulthiame in Sleep Apnea.,"Rationale:  Current therapies for obstructive sleep apnea (OSA) are limited by insufficient efficacy, compliance, or tolerability. An effective pharmacological treatment for OSA is warranted. Carbonic anhydrase inhibition has been shown to ameliorate OSA.  Objectives:  To explore safety and tolerability of the carbonic anhydrase inhibitor sulthiame (STM) in OSA.  Methods:  A 4-week double-blind, randomized, placebo-controlled dose-guiding trial was conducted in patients with moderate and/or severe OSA not tolerating positive airway pressure treatment.  Measurements and Main Results:  Intermittent paresthesia was reported by 79%, 67%, and 18% of patients receiving 400 mg STM ( n  = 34), 200 mg STM ( n  = 12), and placebo ( n  = 22), respectively. Dyspnea was reported after 400 mg STM (18%). Six patients in the higher dose group withdrew because of adverse events. There were no serious adverse events. STM reduced the apnea-hypopnea index from 55.2 to 33.0 events/h (-41.0%) in the 400-mg group and from 61.1 to 40.6 events/h (-32.1%) after 200 mg ( P  < 0.001 for both). Corresponding placebo values were 53.9 and 50.9 events/h (-5.4%). The apnea-hypopnea index reduction threshold of ⩾50% was reached in 40% of patients after 400 mg, 25% after 200 mg, and 5% after placebo. Mean overnight oxygen saturation improved by 1.1% after 400 and 200 mg ( P  < 0.001 and  P  = 0.034, respectively). Patient-related outcomes were unchanged.  Conclusions:  STM showed a satisfactory safety profile in moderate and/or severe OSA. STM reduced OSA, on average, by more than 20 events/h, one of the strongest reductions reported in a drug trial in OSA. Larger scale clinical studies of STM in OSA are justified. Clinical trial registered with www.clinicaltrialsregister.eu (2017-004767-13).",2022,"Mean overnight oxygen saturation improved by 1.1% after 400 mg and 200 mg (p<0.001 and p=0.034, respectively).","['Sleep Apnea', 'obstructive sleep apnea (OSA', 'patients with moderate/severe OSA not tolerating positive airway pressure treatment']","['Carbonic anhydrase (CA) inhibition', 'CA inhibitor sulthiame (STM', 'STM', 'placebo', 'OSA']","['serious adverse events', 'Dyspnea', 'apnea-hypopnea index (AHI', 'STM reduced OSA', 'AHI reduction threshold', 'Mean overnight oxygen saturation']","[{'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0007028', 'cui_str': 'Carbonate dehydratase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0007036', 'cui_str': 'Carbonic anhydrase inhibitor'}, {'cui': 'C0038807', 'cui_str': 'sulthiame'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0038807', 'cui_str': 'sulthiame'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",,0.299024,"Mean overnight oxygen saturation improved by 1.1% after 400 mg and 200 mg (p<0.001 and p=0.034, respectively).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Stenlöf', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Zou', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hoff', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Desitin Arzneimittel GmbH, Hamburg, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Kuhn', 'Affiliation': 'Desitin Arzneimittel GmbH, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lennartz', 'Affiliation': 'Desitin Arzneimittel GmbH, Hamburg, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Grote', 'Affiliation': 'Center for Sleep and Vigilance Disorders, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202109-2043OC']
490,35202621,Azithromycin for Poorly Controlled Asthma in Children: A Randomized Controlled Trial.,"BACKGROUND


Azithromycin has immunomodulatory actions, and its beneficial effects have been demonstrated in asthmatic adults. Data on children are limited.
RESEARCH QUESTION


Does the addition of oral azithromycin to standard therapy in children with poorly controlled asthma improve asthma control compared with standard treatment alone?
STUDY DESIGN AND METHODS


This open-label randomized controlled trial included children (5-15 years of age) with poorly controlled asthma defined by Asthma Control Test (ACT) and Childhood Asthma Control Test (CACT) score of ≤ 19. They were randomized to receive azithromycin (10 mg/kg) three times weekly for 3 months along with standard treatment or standard treatment alone. The primary outcome was the ACT and CACT scores at 3 months. Secondary outcomes were asthma control according to Global Initiative for Asthma (GINA) guidelines, the number of exacerbations, change in spirometry parameters, change in fractional exhaled nitric oxide (Feno) level, positive throat swab results, and side effects.
RESULTS


The trial included 120 children (89 boys; 60 in each group). The mean ± SD age was 9.9 ± 3 years. The baseline parameters were similar between the groups. Mean ± SD ACT and CACT scores (available for 115 children) at 3 months of intervention were 21.71 ± 2.17 vs 18.33 ± 2.19 (P < .001) in the azithromycin and control groups, respectively. The numbers of children with well-controlled asthma according to GINA guidelines were 41 of 56 vs 10 of 56 in the azithromycin and control groups, respectively (P < .001). The median number of exacerbations requiring emergency visit and steroid use were fewer in the azithromycin group: 0 (interquartile range [IQR], 3) vs 1 [IQR, 6]; P < .001). No difference was found in Feno level, spirometry parameters, positive throat swab results, and adverse effects between the groups.
INTERPRETATION


The use of azithromycin in children with poorly controlled asthma resulted in improved asthma control and reduced exacerbations.
TRIAL REGISTRY


Clinical Trials Registry - India; No.: CTRI/2019/06/019727; URL: www.ctri.nic.in.",2022,"There was no difference in FeNO, spirometry parameters, throat swab positivity, and adverse effects between the groups.
","['children (5-15 years old) with poorly controlled asthma defined by asthma control test ', 'Children', 'asthmatic adults', 'children with poorly controlled asthma', 'children with poorly controlled asthma (P', '120 (89 boys) children (60 in each group']","['oral azithromycin (I) to standard therapy (C', 'ACT)/childhood asthma control test (CACT) score ≤ 19', 'azithromycin', 'Azithromycin']","['asthma control and reduced exacerbations', 'numbers of children with well-controlled asthma', 'asthma control as per GINA guidelines, the number of exacerbations, change in spirometry parameters, change in FeNO, throat swab positivity and side effects', 'Mean (SD) ACT/CACT score', 'Median (IQR) number of exacerbations requiring emergency visit and steroid use', 'FeNO, spirometry parameters, throat swab positivity, and adverse effects', 'ACT/CACT score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",120.0,0.275538,"There was no difference in FeNO, spirometry parameters, throat swab positivity, and adverse effects between the groups.
","[{'ForeName': 'Jagat Jeevan', 'Initials': 'JJ', 'LastName': 'Ghimire', 'Affiliation': 'Division of Pediatric Pulmonology and Intensive Care, Department of Pediatrics, New Delhi, India.'}, {'ForeName': 'Kana Ram', 'Initials': 'KR', 'LastName': 'Jat', 'Affiliation': 'Division of Pediatric Pulmonology and Intensive Care, Department of Pediatrics, New Delhi, India. Electronic address: drkanaram@gmail.com.'}, {'ForeName': 'Jhuma', 'Initials': 'J', 'LastName': 'Sankar', 'Affiliation': 'Division of Pediatric Pulmonology and Intensive Care, Department of Pediatrics, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Division of Pediatric Pulmonology and Intensive Care, Department of Pediatrics, New Delhi, India.'}, {'ForeName': 'Venkat K', 'Initials': 'VK', 'LastName': 'Iyer', 'Affiliation': 'Department of Pathology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Hitender', 'Initials': 'H', 'LastName': 'Gautam', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Sood', 'Affiliation': 'Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Kabra', 'Affiliation': 'Division of Pediatric Pulmonology and Intensive Care, Department of Pediatrics, New Delhi, India.'}]",Chest,['10.1016/j.chest.2022.02.025']
491,35202591,Impact of pushing timing on occult injury of levator ani: secondary analysis of a randomized trial.,"BACKGROUND


Evidence of detachment of the levator ani muscle system is seen more frequently in patients with pelvic floor disorders. It has been suggested that passive descent of the fetus before pushing could be used to decrease operative vaginal delivery and levator ani muscle injury.
OBJECTIVE


This planned analysis aimed to determine whether immediate or delayed pushing was associated with an increased proportion of injury to the levator ani muscle system after the first delivery among nulliparous women.
STUDY DESIGN


The Optimizing Management of the Second Stage study was a multicenter randomized trial. Nulliparous women with term pregnancies and neuraxial analgesia were randomly assigned at complete cervical dilation to either immediate pushing or delayed pushing for 1 hour. A subset of participants consented to longitudinal objective pelvic floor assessments: (1) during postpartum stay (initial), (2) at 6 weeks (postpartum 1), and (3) at 6 months (postpartum 2) with transperineal 3-dimensional ultrasound. Following the completion of all visits by all subjects, saved 3-dimensional ultrasound volumes were assessed in a masked fashion. The outcome was ""occult"" levator ani muscle injury on the right or left, defined as a widening of the attachment of the levator ani to its origin utilizing the levator-urethra gap measurement. Measurements and proportions were compared between the 2 groups by study visit using the χ 2  test or Fisher exact test for categorical variables and the t test or Mann-Whitney U test for continuous variables as appropriate.
RESULTS


Here, 941 of 2414 randomized subjects (39.0%) participated in the pelvic floor assessments: 452 in the immediate pushing group and 489 in the delayed pushing group. We obtained sonograms on 67%, 83%, and 77% of the pelvic floor assessment participants at the initial, postpartum 1, and postpartum-2 visits, respectively. Demographic and labor characteristics were comparable between the 2 groups; 94% of participants were non-Hispanic, and 50% of participants were Black. Levator ani muscle injury was noted in 77 participants (13.6%) at the initial visit, 99 (13.1%) at PP1, and 72 (10.6%) at PP2. There was no difference in injury between women in the immediate pushing group and women in the delayed pushing group. These findings did not change when the threshold (sensitivity) of levator ani muscle injury was adjusted to a less conservative measure.
CONCLUSION


Among nulliparous women at term with neuraxial analgesia, the rates of occult levator ani muscle injury were not different between women undergoing immediate pushing and women undergoing delayed pushing in the second stage of labor. Further research efforts are needed to understand the development and potential prevention of subsequent pelvic floor disorders.",2022,"Levator ani muscle injury was noted in 77 (13.6%) participants at the initial visit, 99 (13.1%) at PP1, and 72 (10.6%) at PP2.","['nulliparous women at term with', '941 (39.0%) of 2414 randomized participants participated in the pelvic floor assessments; 452 in the immediate pushing and 489 in the delayed pushing groups', 'nulliparous women', 'patients with pelvic floor disorders', 'Nulliparous women with term pregnancies and neuraxial analgesia']","['transperineal 3-Dimensional ultrasound', 'complete cervical dilation to either immediate pushing or delayed pushing for 1 hour', 'neuraxial analgesia']","['Demographic and labor characteristics', 'occult"" levator ani muscle injury on the right or left, defined as a widening of the attachment of the levator ani to its origin utilizing the Levator Urethra Gap measurement', 'saved 3-Dimensional ultrasound volumes', 'Levator ani muscle injury']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1963096', 'cui_str': 'AE-941'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178892', 'cui_str': 'Pelvic Floor Diseases'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0205500', 'cui_str': 'Perineal approach'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0224384', 'cui_str': 'Structure of levator ani muscle'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",2414.0,0.159637,"Levator ani muscle injury was noted in 77 (13.6%) participants at the initial visit, 99 (13.1%) at PP1, and 72 (10.6%) at PP2.","[{'ForeName': 'W Thomas', 'Initials': 'WT', 'LastName': 'Gregory', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR. Electronic address: gregoryt@ohsu.edu.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': ""Department of Women's Health, Dell School of Medicine, The University of Texas at Austin, Austin, TX.""}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Woolfolk', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO.'}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Lowder', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO.'}, {'ForeName': 'Aaron B', 'Initials': 'AB', 'LastName': 'Caughey', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ""Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, AL; Center for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL.""}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO; Department of Obstetrics and Gynecology, Warren Alpert School of Medicine of Brown University and Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': ""Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, AL; Center for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2022.02.020']
492,35246982,Before-School Physical Activity Program's Impact on Social and Emotional Learning.,"BACKGROUND


Despite the positive impact of social and emotional learning (SEL) on the emotional well-being of children, literature on physical activity engagement and SEL among this population has been limited. Therefore, the purpose of this study was to examine whether school students' SEL would improve after participation in a before-school physical activity program.
METHODS


A total of 138 fourth and sixth grade students from 1 elementary school and 1 middle school participated in this study. Seventy-five students participated in the before-school physical activity program, while 63 students were in the control group. The physical education teachers implemented the program 3 days per week, for 3 weeks. The participants completed a 10-question adapted Devereux Student Strengths Assessment-Mini before and after the program. Repeated measures ANOVA was run to determine the effects of the program on SEL competence.
RESULTS


The fourth and sixth grade students who participated in the program reported a 7 and 10% improvement in pre- versus post-intervention SEL competence, respectively. Students in the control group reported no change in their SEL competence.
CONCLUSION


Considering the benefits of a before-school physical activity program on students' SEL, stakeholders should consider including more physical activity programming within school policies.",2022,"Students in the control group reported no change in their SEL competence.
","['A total of 138 fourth and sixth grade students from 1 elementary school and 1 middle school participated in this study', 'school students', 'Seventy-five students participated in the before-school physical activity program, while 63 students were in the control group']","['social and emotional learning (SEL', 'SEL']","['Social and Emotional Learning', 'SEL competence']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0582589', 'cui_str': 'Emotional learning'}]","[{'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",75.0,0.015232,"Students in the control group reported no change in their SEL competence.
","[{'ForeName': 'Tan Leng', 'Initials': 'TL', 'LastName': 'Goh', 'Affiliation': 'Department of Physical Education and Human Performance, Central Connecticut State University, 1615 Stanley Street, New Britain, CT, 06050, USA.'}, {'ForeName': 'Chee Hoi', 'Initials': 'CH', 'LastName': 'Leong', 'Affiliation': 'Department of Physical Education and Human Performance, Central Connecticut State University, 1615 Stanley Street, New Britain, CT, 06050, USA.'}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'Fede', 'Affiliation': 'Department of Health and Movement Sciences, Southern Connecticut State University, 501 Crescent Street, New Haven, CT, 06515, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ciotto', 'Affiliation': 'School of Education and Professional Studies, Central Connecticut State University, 1615 Stanley Street, New Britain, CT, 06050, USA.'}]",The Journal of school health,['10.1111/josh.13167']
493,35216854,Enhancing risk perception may be insufficient to curtail prescription opioid use and misuse among youth after surgery: A randomized controlled trial.,"OBJECTIVE


This randomized controlled trial examined whether an interactive, risk-focused educational program was associated with higher risk perceptions and decreased prescription opioid use/misuse among emerging adults.
METHODS


503 participants aged 15-24 years scheduled for ambulatory surgery were randomized to routine prescription education with or without our Scenario-Tailored Opioid Messaging Program (STOMP) provided prior to receipt of a prescribed opioid. Surveys were completed preoperatively, and at days 7&14, months 1&3 postoperatively. Outcomes included analgesic risk perceptions, opioid use, and misuse intentions/behavior.
RESULTS


Compared to Controls, STOMP was associated with stable but higher risk perceptions on day 14 (β = 1.76 [95% CI 0.53, 2.99], p = .005) and month 3 (β = 2.13 [95% CI 0.86, 3.40], p = .001). There was no effect of STOMP or analgesic misuse risk perceptions on days of opioid use or subsequent misuse intentions/behavior. The degree to which participants valued pain relief over analgesic risk (trade-off preference) was, however, associated with prolonged postoperative opioid use and later misuse.
CONCLUSION


Education emphasizing the risks of opioids was insufficient in reducing opioid use and misuse in youth who were prescribed these analgesics for acute pain relief.
PRACTICE IMPLICATIONS


Education may need to better address analgesic expectations to shorten opioid use and mitigate misuse.",2022,There was no effect of STOMP or analgesic misuse risk perceptions on days of opioid use or subsequent misuse intentions/behavior.,['503 participants aged 15-24 years scheduled for ambulatory surgery'],"['interactive, risk-focused educational program', 'STOMP', 'routine prescription education with or without our Scenario-Tailored Opioid Messaging Program (STOMP) provided prior to receipt of a prescribed opioid']","['analgesic risk perceptions, opioid use, and misuse intentions/behavior']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",503.0,0.12644,There was no effect of STOMP or analgesic misuse risk perceptions on days of opioid use or subsequent misuse intentions/behavior.,"[{'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Voepel-Lewis', 'Affiliation': 'Department of Health Behavior and Biological Science at the School of Nursing, University of Michigan, Ann Arbor, MI 48109, USA; Department of Pediatric Anesthesiology at Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, USA. Electronic address: terriv@umich.edu.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Veliz', 'Affiliation': 'Department of Pediatric Anesthesiology at Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Heinze', 'Affiliation': 'Department of Health Behavior and Health Education at the School of Public Health, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Boyd', 'Affiliation': 'Department of Health Behavior and Biological Science at the School of Nursing, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zikmund-Fisher', 'Affiliation': 'Department of Health Behavior and Health Education at the School of Public Health, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lenko', 'Affiliation': 'Department of Pediatric Anesthesiology at Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grant', 'Affiliation': 'Department of Orthopedic Surgery at Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Bromberg', 'Affiliation': 'Department of Pediatric Anesthesiology at Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Kelly', 'Affiliation': 'Department of Pediatric Anesthesiology at Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Tait', 'Affiliation': 'Department of Pediatric Anesthesiology at Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, USA.'}]",Patient education and counseling,['10.1016/j.pec.2022.01.015']
494,35216853,Encouraging COVID-19 vaccination via an evolutionary theoretical approach: A randomized controlled study in Japan.,"OBJECTIVE


We aimed to examine the effect of a message that target the fundamental human motive of kin care on COVID-19 vaccination recommendations among participants with young children, based on an evolutionary theoretical approach.
METHODS


Participants with young children (n = 969) were randomly assigned either to a group that received an intervention message that targeted the fundamental motive of kin care, or that targeted the fundamental motive of disease avoidance, or a control message. Intention to receive COVID-19 vaccination was assessed both before and after reading the messages. A one-way ANOVA with Tukey's or Games-Howell test was conducted.
RESULTS


An intervention message targeting the fundamental motive of kin care and disease avoidance significantly increased intention of vaccination versus a control message (p < 0.001, respectively).
CONCLUSION


The evolutionary theoretical approach that focuses on fundamental human motives has the potential to extend the communication strategy for COVID-19 vaccination recommendations.
PRACTICE IMPLICATIONS


Health professionals should deliver messages that target the fundamental motive of kin care as well as messages about the susceptibility and severity of COVID-19 and vaccine efficacy (e.g., ""Get vaccinated against COVID-19 for your child's sake, because if you are infected, you will be unable to care for your child."").",2022,"An intervention message targeting the fundamental motive of kin care and disease avoidance significantly increased intention of vaccination versus a control message (p < 0.001, respectively).
","['Participants with young children (n\xa0=\xa0969', 'participants with young children, based on an evolutionary theoretical approach', 'Japan']","['intervention message that targeted the fundamental motive of kin care, or that targeted the fundamental motive of disease avoidance, or a control message']",[],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],969.0,0.13512,"An intervention message targeting the fundamental motive of kin care and disease avoidance significantly increased intention of vaccination versus a control message (p < 0.001, respectively).
","[{'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Okuhara', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan. Electronic address: okuhara-ctr@umin.ac.jp.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Goto', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Tsunezumi', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Kagawa', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kiuchi', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}]",Patient education and counseling,['10.1016/j.pec.2022.02.013']
495,35216834,The sex-specific difference in singleton birth weight after frozen embryo transfer compared with fresh embryo transfer: a secondary analysis of 3 randomized trials.,"OBJECTIVE


To assess whether the between-group difference in singleton birth weight following frozen vs. fresh embryo transfer varied with infant sex.
DESIGN


A post hoc exploratory secondary analysis of data from three multicenter randomized trials compared the live birth rates between freeze-only vs. fresh embryo transfer.
SETTING


Academic fertility centers.
PATIENT(S)


A total of 1,886 women who achieved singleton live birth after a frozen or fresh embryo transfer during these trials were included.
INTERVENTION(S)


Women underwent either a frozen or fresh embryo transfer.
MAIN OUTCOME MEASURE(S)


Mean birth weight, large for gestational age (LGA), and small for gestational age (SGA).
RESULT(S)


There was an interaction between the types of embryo transfer and infant sex on the birth weight and on the incidences of LGA and SGA. Among male infants, compared with singletons following fresh embryo transfer, singletons following frozen embryo transfer had higher mean birth weights (3,520.6 ± 526.1 vs. 3,345.1 ± 524.9 g), a higher risk of being LGA (25.2% vs. 15.7%), and a lower risk of being SGA (3.3% vs. 6.1%). However, among the female infants, no statistically significant difference was found in the mean birth weight (3,336.5 ± 514.8 vs. 3,299.5 ± 485.0 g) or the risks of being LGA (18.8% vs. 15.7%) or SGA (5.2% vs. 6.0%) between frozen and fresh embryo transfer.
CONCLUSION(S)


Male singletons born after frozen embryo transfer were more likely to have a higher birth weight than those born after fresh embryo transfer.",2022,"Among male infants, compared with singletons following fresh embryo transfer, singletons following frozen embryo transfer had higher mean birth weights (3,520.6 ± 526.1 vs. 3,345.1 ± 524.9 g), a higher risk of being LGA (25.2% vs. 15.7%), and a lower risk of being SGA (3.3% vs. 6.1%).","['Academic fertility centers', 'male infants', '1,886 women who achieved singleton live birth after a frozen or fresh embryo transfer during these trials were included']","['frozen embryo transfer compared with fresh embryo transfer', 'frozen or fresh embryo transfer', 'frozen vs. fresh embryo transfer', 'freeze-only vs. fresh embryo transfer']","['live birth rates', 'mean birth weight', 'risks of being LGA', 'singleton birth weight', 'birth weight', 'mean birth weights', 'lower risk of being SGA', 'Mean birth weight, large for gestational age (LGA), and small for gestational age (SGA', 'higher risk of being LGA']","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",1886.0,0.129607,"Among male infants, compared with singletons following fresh embryo transfer, singletons following frozen embryo transfer had higher mean birth weights (3,520.6 ± 526.1 vs. 3,345.1 ± 524.9 g), a higher risk of being LGA (25.2% vs. 15.7%), and a lower risk of being SGA (3.3% vs. 6.1%).","[{'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China; The Key Laboratory of Reproductive Endocrinology of Ministry of Education, Jinan, People's Republic of China; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, People's Republic of China.""}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Obstetrics and Gynecology, The Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China.""}, {'ForeName': 'Qiaoqiao', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': ""Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China; The Key Laboratory of Reproductive Endocrinology of Ministry of Education, Jinan, People's Republic of China; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China; The Key Laboratory of Reproductive Endocrinology of Ministry of Education, Jinan, People's Republic of China; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': ""Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China; The Key Laboratory of Reproductive Endocrinology of Ministry of Education, Jinan, People's Republic of China; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China; The Key Laboratory of Reproductive Endocrinology of Ministry of Education, Jinan, People's Republic of China; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, People's Republic of China.""}, {'ForeName': 'Shigang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China; The Key Laboratory of Reproductive Endocrinology of Ministry of Education, Jinan, People's Republic of China; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, People's Republic of China.""}, {'ForeName': 'Daimin', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': ""Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China; The Key Laboratory of Reproductive Endocrinology of Ministry of Education, Jinan, People's Republic of China; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, People's Republic of China. Electronic address: sdweidaimin@163.com.""}, {'ForeName': 'Zi-Jiang', 'Initials': 'ZJ', 'LastName': 'Chen', 'Affiliation': ""Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China; The Key Laboratory of Reproductive Endocrinology of Ministry of Education, Jinan, People's Republic of China; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, People's Republic of China.""}]",Fertility and sterility,['10.1016/j.fertnstert.2022.01.015']
496,35226080,Effectiveness of Acupuncture for Pain Control After Cesarean Delivery: A Randomized Clinical Trial.,"IMPORTANCE


A pharmacological approach to pain control after cesarean delivery is often insufficient on its own. Acupuncture is a promising method for mitigating postoperative pain and reducing postoperative opioid requirements.
OBJECTIVE


To evaluate the efficacy and effectiveness of acupuncture as an adjunctive therapy for pain control after cesarean delivery, compared with a placebo intervention and standard care alone.
DESIGN, SETTING, AND PARTICIPANTS


This single-center, placebo-controlled, patient- and assessor-blinded randomized clinical trial was conducted from January 13, 2015, to June 27, 2018, at a tertiary university hospital in Greifswald, Germany. Participants were women who were scheduled for elective cesarean delivery under spinal anesthesia and were randomized to either the acupuncture group (n = 60) or placebo group (n = 60). Another 60 consecutive patients who met the eligibility criteria and received the standard postoperative analgesia were selected to form a nonrandomized standard care group. The intention-to-treat analysis was performed from August 19, 2019, to September 13, 2019.
INTERVENTIONS


In addition to standard pain treatment, each patient in the acupuncture group received auricular and body acupuncture with indwelling intradermal needles, whereas patients in the placebo group were treated with nonpenetrating placebo needles.
MAIN OUTCOMES AND MEASURES


The primary outcome was pain intensity on movement, which was measured using an 11-item verbal rating scale. Secondary outcomes were analgesia-related adverse effects, analgesics consumption, time to mobilization and Foley catheter removal, quality of patient blinding to randomization, and patient satisfaction with treatment of pain.
RESULTS


A total of 180 female patients (mean [SD] age, 31 [5] years) were included in the intention-to-treat analysis. The mean pain intensity on movement in the acupuncture group on the first postoperative day was lower than in the placebo group (4.7 [1.8] vs 6.0 [2.0] points; Cohen d, 0.73; 95% CI, 0.31-1.01; P = .001) and the standard care group (6.3 [1.3] points; Cohen d, 1.01; 95% CI, 0.63-1.40; P < .001). On the first postoperative day, 59 patients (98%) in the acupuncture group were fully mobilized vs 49 patients (83%) in the placebo group (relative risk [RR], 1.18; 95% CI, 1.06-1.33; P = .01) and 35 patients (58%) in the standard care group (RR, 1.69; 95% CI, 1.36-2.09; P < .001). The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57; P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62; P = .002). Other parameters were comparable across the 3 study groups.
CONCLUSIONS AND RELEVANCE


Results of this trial showed that acupuncture was safe and effective in reducing pain and accelerating mobilization of patients after cesarean delivery. With consideration for personnel and time expenditures, acupuncture can be recommended as routine, supplemental therapy for pain control in patients after elective cesarean delivery.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02364167.",2022,"The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57; P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62; P = .002).","['January 13, 2015, to June 27, 2018, at a tertiary university hospital in Greifswald, Germany', 'patients after elective cesarean delivery', '60 consecutive patients who met the eligibility criteria and received the standard postoperative analgesia were selected to form a nonrandomized standard care group', '180 female patients (mean [SD] age, 31 [5] years) were included in the intention-to-treat analysis', 'Participants were women who were scheduled for elective cesarean delivery under spinal anesthesia']","['acupuncture', 'auricular and body acupuncture with indwelling intradermal needles', 'placebo', 'Acupuncture', 'placebo intervention and standard care alone', 'nonpenetrating placebo needles']","['analgesia-related adverse effects, analgesics consumption, time to mobilization and Foley catheter removal, quality of patient blinding to randomization, and patient satisfaction with treatment of pain', 'Pain Control', 'pain and accelerating mobilization', 'pain intensity on movement, which was measured using an 11-item verbal rating scale', 'Foley catheter', 'mean pain intensity', 'efficacy and effectiveness']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",180.0,0.778338,"The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57; P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62; P = .002).","[{'ForeName': 'Taras I', 'Initials': 'TI', 'LastName': 'Usichenko', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Berthold Johannes', 'Initials': 'BJ', 'LastName': 'Henkel', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Klausenitz', 'Affiliation': 'Department of Radiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesse', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Pierdant', 'Affiliation': 'Department of Gynecology and Obstetrics, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Cummings', 'Affiliation': 'British Medical Acupuncture Society, London, United Kingdom.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hahnenkamp', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0517']
497,35232299,"Recruiting an underserved, difficult to reach population into a cancer trial: Strategies from the  Restore- 2 Rehabilitation Trial for gay and bisexual prostate cancer patients.","BACKGROUND/AIMS


Sexual minorities are small and under-researched populations that are at disproportionate risk for cancer and poor cancer outcomes. Described as a ""hidden population,"" the principal research challenge has been to develop effective methods to identify and recruit such cancer patients into cancer studies. Online recruitment strategies, as well as targeted clinic recruitment using patient-entered sexual orientation and gender identity data from electronic medical records have potential to transform recruitment, but studies testing the effects of how to recruit using these have not been published.
METHODS


In 2019, we conducted a naturalistic, three-arm, stratified prospective study to compare three recruitment strategies: (a) clinic based recruitment of prostate cancer patients from gay health and urology clinics; (b) directly from the gay community; and (c) online recruitment (through cancer support, sex/dating, and social sites). For each strategy, we estimated time, workload, and direct costs involved. To study how recruitment strategy may affect sampling, we tested for retention rates, demographic and outcome differences across sites. Using these methods, we successfully recruited 401 gay and bisexual prostate cancer patients into a randomized, controlled, 24-month trial testing an online sexual and urinary rehabilitation curriculum tailored for this population.
RESULTS


There were seven key results. First, it is possible to recruit substantial numbers of sexual minority men into prostate cancer studies provided online recruitment methods are used. Second, we observed big differences in dropout during study onboarding by recruitment source. Third, within online recruitment, the online sex/dating application (app) was the most successful and efficient, followed by the cancer support site, and then the social networking site. Fourth, while clinics were the cheapest source of recruitment, they were time intensive and low in yield. Fifth, the cancer support site and sex/dating app recruits differed by several characteristics, with the former being more rehabilitation-focused while the latter were younger and more sexually active. Sixth, we found almost no differences in outcomes across the three online recruitment sites. Seventh, because retention in online studies has been a concern, we confirm very low attrition at 3- and 6 months into the trial.
CONCLUSION


For sexual minority cancer research, more research on how to use sexual orientation and gender identity electronic medical record data for clinic-based recruitment is needed. For other small or hard-to-reach populations, researchers should compare and publish online versus offline recruitment strategies.",2022,"Third, within online recruitment, the online sex/dating application (app) was the most successful and efficient, followed by the cancer support site, and then the social networking site.","['prostate cancer patients from gay health and urology clinics; (b) directly from the gay community; and (c) online recruitment (through cancer support, sex/dating, and social sites', 'gay and bisexual prostate cancer patients', '401 gay and bisexual prostate cancer patients']",['online sexual and urinary rehabilitation curriculum tailored for this population'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],,0.110588,"Third, within online recruitment, the online sex/dating application (app) was the most successful and efficient, followed by the cancer support site, and then the social networking site.","[{'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Simon Rosser', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Hoefer', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Polter', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Kohli', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Wheldon', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Haggart', 'Affiliation': 'Department of Urology, Medical School, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kristine Mc', 'Initials': 'KM', 'LastName': 'Talley', 'Affiliation': 'Adult and Gerontological Health Cooperative, School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Mitteldorf', 'Affiliation': 'Malecare Cancer Support, New York, NY, USA.'}, {'ForeName': 'Gunna', 'Initials': 'G', 'LastName': 'Kilian', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, Rush Medical College, Chicago, IL, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Ross', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'West', 'Affiliation': 'Department of Writing Studies, University of Minnesota, Minneapolis, MN, USA.'}]","Clinical trials (London, England)",['10.1177/17407745221077678']
498,35247147,Family support-based intervention using a mobile application provided by pharmacists for older adults with diabetes to improve glycaemic control: a randomised controlled trial.,"Background Family support is crucial in the care of older patients with diabetes. However, more information is needed to evaluate the potential benefits of family-based intervention through a mobile application by pharmacists in the older diabetes patients. Aim To evaluate the effectiveness of family support-based intervention via a mobile application by pharmacists on clinical outcomes, family behaviour, diabetes knowledge, self-management practices and medication adherence in older adults with type 2 diabetes. Method A randomised controlled trial was conducted in a hospital in the south of Thailand with 9 months of follow-up. Family members in the intervention group (n = 78) received diabetes educational courses and encouragement via a mobile application from pharmacists to help their older relatives with diabetes in self-management tasks. The control group received usual care (n = 79). Results As compared to baseline, significant improvements were observed in the intervention patients for glycosylated haemoglobin (HbA 1c ), blood pressure, family behaviour in diabetes care, diabetes knowledge, self-management practices and medication adherence (P < 0.001). The intervention group showed greater decline in HbA 1c  levels relative to the control group (- 0.97% vs. - 0.12%; P = 0.001). Significant differences between groups for changes in blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence were found (P ≤ 0.001), with the intervention group showing greater improvement. Conclusion Family support intervention via a mobile application by pharmacists is beneficial to diabetes care for older adults.Trial registration number: TCTR20200615001 (date 13 June 2020, retrospectively registered).",2022,"Significant differences between groups for changes in blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence were found (P ≤ 0.001), with the intervention group showing greater improvement.","['older adults with diabetes to improve glycaemic control', 'older patients with diabetes', 'older relatives with diabetes in self-management tasks', 'older adults with type 2 diabetes', 'older diabetes patients', 'older adults', 'hospital in the south of Thailand with 9\xa0months of follow-up']","['diabetes educational courses and encouragement via a mobile application from pharmacists', 'usual care', 'family support-based intervention via a mobile application by pharmacists']","['glycosylated haemoglobin (HbA 1c ), blood pressure, family behaviour in diabetes care, diabetes knowledge, self-management practices and medication adherence', 'decline in HbA 1c  levels relative', 'blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence', 'clinical outcomes, family behaviour, diabetes knowledge, self-management practices and medication adherence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1321224', 'cui_str': 'Family behavior'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0290805,"Significant differences between groups for changes in blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence were found (P ≤ 0.001), with the intervention group showing greater improvement.","[{'ForeName': 'Potjana', 'Initials': 'P', 'LastName': 'Poonprapai', 'Affiliation': 'Pharmacy Division, Sadao Hospital, Songkhla, Thailand.'}, {'ForeName': 'Sanguan', 'Initials': 'S', 'LastName': 'Lerkiatbundit', 'Affiliation': 'Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Woranuch', 'Initials': 'W', 'LastName': 'Saengcharoen', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand. woranuch.s@psu.ac.th.'}]",International journal of clinical pharmacy,['10.1007/s11096-022-01389-5']
499,35212740,"Consuming a Protein and Fiber-Based Supplement Preload Promotes Weight Loss and Alters Metabolic Markers in Overweight Adults in a 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Higher protein and fiber diets promote weight management and metabolic health.
OBJECTIVES


This study aimed to determine if greater weight loss and positive changes in metabolic outcomes could be achieved with twice-daily consumption of a high-protein and fiber-based multi-ingredient nutritional shake (HPF) compared with an isocaloric low-protein, lower fiber-based placebo (LPF).
METHODS


Study procedures were conducted by an independent research organization under clinicaltrials.gov registration NCT03057873. Healthy overweight and obese adults [n = 206; BMI (kg/m2): 27-35; 70% female] were randomly assigned to HPF or LPF. All participants were prescribed an energy-restricted diet (500 kcal/d less than energy needs) and consumed a HPF (17 g protein, 6 g fiber) or LPF (1 g protein, 3 g fiber) shake 30 min before breakfast and lunch for 12 wk. Primary outcomes included body weight and total body fat percentage. Blood samples were collected at days (D) 0, 28, 56, and 84 for secondary analyses related to metabolic markers of health.
RESULTS


Although weight loss occurred in both groups, HPF had greater weight loss at D84 compared with LPF (-3.3 kg vs. -1.8 kg, P < 0.05). Percentage body fat decreased in both groups (HPF: -1.33%, LPF: -1.09%; P < 0.001) with no differences between groups. Serum total cholesterol, LDL cholesterol, and oxidized LDL decreased between -5.1% to -8.3%, whereas adiponectin increased over time in both groups; these changes occurred to a greater extent in HPF compared with LPF (all P < 0.05).
CONCLUSIONS


A multi-ingredient HPF nutritional supplement shake consumed as a preload before breakfast and lunch positively influenced weight management and metabolic outcomes in overweight adults compared with an LPF placebo. These findings suggest that specific nutrient factors (i.e., potentially including protein, fiber, and bioactive content) other than calorie reduction alone influence the success of a weight-loss regimen. This trial was registered at www.clinicaltrials.gov as NCT03057873.",2022,"Percent body fat decreased in both groups (HPF: -1.33%, LPF: -1.09%; P < 0.001) with no differences between groups.","['Overweight Adults', 'Healthy overweight and obese adults [n\xa0=\xa0206, body mass index 27-35\xa0kg/m2, 70% female', 'overweight adults']","['Protein and Fiber-based Supplement Preload', 'Placebo', 'LPF placebo', 'isocaloric lower protein, fiber-based placebo (LPF', 'high protein and fiber-based multi-ingredient nutritional shake (HPF', 'HPF', 'LPF', 'HPF or LPF']","['weight loss', 'Serum total cholesterol, LDL cholesterol, and oxidized LDL', 'Blood samples', 'metabolic markers of health', 'body weight and total body fat percentage', 'weight management and metabolic outcomes', 'adiponectin', 'Percent body fat']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",,0.0778229,"Percent body fat decreased in both groups (HPF: -1.33%, LPF: -1.09%; P < 0.001) with no differences between groups.","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Glynn', 'Affiliation': 'Scientific Affairs, Beachbody, LLC, El Segundo, CA, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Fleming', 'Affiliation': 'Traverse Science, Inc., Champaign, IL, USA.'}, {'ForeName': 'Caitlyn G', 'Initials': 'CG', 'LastName': 'Edwards', 'Affiliation': 'Traverse Science, Inc., Champaign, IL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wilson', 'Affiliation': 'Research and Development, Beachbody, LLC, El Segundo, CA, USA.'}, {'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science, Inc., London, Onatario, Canada.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leidy', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}]",The Journal of nutrition,['10.1093/jn/nxac038']
500,35552528,"Antipsychotic Efficacy of KarXT (Xanomeline-Trospium): Post Hoc Analysis of Positive and Negative Syndrome Scale Categorical Response Rates, Time Course of Response, and Symptom Domains of Response in a Phase 2 Study.","Objective:  To evaluate Positive and Negative Syndrome Scale (PANSS) categorical response rates, time course of response, and symptom subdomains of response with the combination oral agent KarXT (xanomeline-trospium) in the treatment of schizophrenia.
Methods:  Post hoc analysis was conducted for EMERGENT-1 (NCT03697252), a 5-week, inpatient, placebo-controlled, phase 2 study of acute psychosis in patients who met  DSM-5  criteria for schizophrenia. The EMERGENT-1 study was conducted between September 2018 and August 2019. Categorical thresholds of response used were PANSS total score reductions of ≥ 20%, ≥ 30%, ≥ 40%, and ≥ 50% between baseline and study end. Number needed to treat (NNT) for each categorical threshold was calculated. The proportion of KarXT- and placebo-treated patients achieving each response threshold at weeks 2, 4, and 5 was assessed. Marder 5-factor analysis of PANSS assessed response with KarXT across symptom domains.
Results:  A total of 83 patients in the KarXT group and 87 patients in the placebo group were included in the modified intent-to-treat analysis. Response rates with KarXT ranged from 59.0% for a ≥ 20% threshold to 15.7% for a ≥ 50% threshold. All response rates with KarXT were significantly higher than in the placebo arm ( P  < .05), with NNTs ranging from 3 (≥ 20% improvement) to 11 (≥ 50% improvement). KarXT was associated with a significantly higher response rate relative to placebo as early as 2 weeks for ≥ 20% ( P  = .0001) and ≥ 30% ( P  = .0022) thresholds and at 4 weeks for the ≥ 40% ( P  = .0049) and ≥ 50% ( P  = .0041) thresholds. Each of the Marder 5 factors showed significant differences favoring KarXT over placebo ( P  < .05) by 2 weeks and continuing through week 5 (endpoint Cohen  d  effect sizes, 0.48-0.66).
Conclusions:  KarXT provided clinically meaningful responder rates on PANSS total score compared with placebo at each response threshold, providing further support of the successful primary and secondary endpoints. Response was demonstrated as early as 2 weeks relative to placebo. KarXT demonstrated improvements vs placebo in all 5 factors (positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility, and anxiety/depression).
Trial Registration:  ClinicalTrials.gov identifier: NCT03697252.",2022,"KarXT demonstrated improvements vs placebo in all 5 factors (positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility, and anxiety/depression).
","['83 patients in the KarXT group and 87 patients in the', 'study was conducted between September 2018 and August 2019', 'patients who met  DSM-5  criteria for schizophrenia']","['placebo', 'Xanomeline-Trospium', 'KarXT', 'combination oral agent KarXT (xanomeline-trospium']","['Response rates', '5 factors (positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility, and anxiety/depression', 'response rates with KarXT', 'Antipsychotic Efficacy', 'Positive and Negative Syndrome Scale (PANSS) categorical response rates, time course of response, and symptom subdomains of response', 'Positive and Negative Syndrome Scale Categorical Response Rates, Time Course of Response, and Symptom Domains of Response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246836', 'cui_str': 'xanomeline'}, {'cui': 'C0772089', 'cui_str': 'Trospium'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.24971,"KarXT demonstrated improvements vs placebo in all 5 factors (positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility, and anxiety/depression).
","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Weiden', 'Affiliation': 'Karuna Therapeutics, Boston, Massachusetts.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Breier', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kavanagh', 'Affiliation': 'Kavanagh Statistical Consulting, Apex, North Carolina.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Miller', 'Affiliation': 'Karuna Therapeutics, Boston, Massachusetts.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Brannan', 'Affiliation': 'Karuna Therapeutics, Boston, Massachusetts.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Paul', 'Affiliation': 'Karuna Therapeutics, Boston, Massachusetts.'}]",The Journal of clinical psychiatry,['10.4088/JCP.21m14316']
501,35220371,Left Ventricular Adaptation to Exercise Training via Magnetic Resonance Imaging: Studies of Twin Responses to Understand Exercise THerapy.,"PURPOSE


Changes in left ventricular mass (LVM) and end-diastolic volume (EDV) in response to exercise training are important determinants of functional capacity in health and disease, but the impact of different exercise modalities remains unclear.
METHODS


Using a randomized crossover design we studied the impact of resistance (RES) and endurance (END) training using cardiac magnetic resonance imaging in previously untrained monozygotic (MZ) and dizygotic (DZ) twin pairs (n = 72; 22 MZ pairs, 14 DZ same-sex pairs; 26.1 ± 5.4 yr). Twins, as pairs, undertook 3 months of RES and 3 months of END training (order randomized), separated by a 3-month washout.
RESULTS


Group results revealed that END increased LVM (P < 0.001) and EDV (P = 0.007), whereas RES did not (P > 0.05). A higher proportion of individuals responded to END than RES for LVM (72% vs 38%, P < 0.001) and EDV (67% vs 40%, P = 0.003). Baseline cross-sectional intraclass correlations were higher for MZ than DZ twin pairs for all variables (e.g., LVM heritability = 0.42), but no significant correlations were apparent between pairs for change in any variable in response to either RES or END (P > 0.05).
CONCLUSIONS


Our findings indicate that cardiac adaptation in response to exercise is modality-specific and that low responders to one mode of exercise can be high responders to an alternative. Heritability estimates based on cross-sectional data, which suggested a genetic contribution to LVM, do not accord with estimates based on training effects, which indicated limited genetic impact on adaptation in this 3-month study of exercise training. This study has implications for understanding the physiological and health impacts of typically used exercise modalities on cardiac adaptation in previously untrained individuals.",2022,"A higher proportion of individuals responded to END than RES for LVM (72 vs 38%, P < 0.001) and EDV (67 vs 40%, P = 0.003).","['previously untrained individuals', 'previously untrained monozygotic (MZ) and dizygotic (DZ) twin pairs (n = 72; 22MZ pairs, 14DZ same-sex pairs; 26.1 ± 5.4 yr']","['resistance (RES) and endurance (END) training using cardiac magnetic resonance imaging', 'exercise training']","['Baseline cross-sectional intra-class correlations', 'EDV', 'LVM']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041429', 'cui_str': 'Fraternal twin'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C4517792', 'cui_str': '5.4'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}]",,0.0135768,"A higher proportion of individuals responded to END than RES for LVM (72 vs 38%, P < 0.001) and EDV (67 vs 40%, P = 0.003).","[{'ForeName': 'Channa E', 'Initials': 'CE', 'LastName': 'Marsh', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Thomas', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': ''}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Scurrah', 'Affiliation': 'Twins Research Australia, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Victoria, AUSTRALIA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002899']
502,35230884,"Weekly Cisplatin Plus Radiation for Postoperative Head and Neck Cancer (JCOG1008): A Multicenter, Noninferiority, Phase II/III Randomized Controlled Trial.","PURPOSE


The standard treatment for postoperative high-risk locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) is chemoradiotherapy with 3-weekly cisplatin (100 mg/m 2 ). However, whether chemoradiotherapy with weekly cisplatin (40 mg/m 2 ) yields comparable efficacy with 3-weekly cisplatin in postoperative high-risk LA-SCCHN is unknown.
PATIENTS AND METHODS


In this multi-institutional open-label phase II/III trial, patients with postoperative high-risk LA-SCCHN were randomly assigned to receive either chemoradiotherapy with 3-weekly cisplatin (100 mg/m 2 ) or with weekly cisplatin (40 mg/m 2 ) to confirm the noninferiority of weekly cisplatin. The primary end point of phase II was the proportion of treatment completion, and that of phase III was overall survival. A noninferiority margin of hazard ratio was set at 1.32.
RESULTS


Between October 2012 and December 2018, a total of 261 patients were enrolled (3-weekly cisplatin, 132 patients; weekly cisplatin, 129 patients). At the planned third interim analysis in the phase III part, after a median follow-up of 2.2 (interquartile range 1.19-3.56) years, chemoradiotherapy with weekly cisplatin was noninferior to 3-weekly cisplatin in terms of overall survival, with a hazard ratio of 0.69 (99.1% CI, 0.374 to 1.273 [< 1.32], one-sided  P  for noninferiority = .0027 < .0043). Grade 3 or more neutropenia and infection were less frequent in the weekly arm (3-weekly  v  weekly, 49%  v  35% and 12%  v  7%, respectively), as were renal impairment and hearing impairment. No treatment-related death was reported in the 3-weekly arm, and two (1.6%) in the weekly arm.
CONCLUSION


Chemoradiotherapy with weekly cisplatin is noninferior to 3-weekly cisplatin for patients with postoperative high-risk LA-SCCHN. These findings suggest that chemoradiotherapy with weekly cisplatin can be a possible treatment option for these patients.",2022,"Grade 3 or more neutropenia and infection were less frequent in the weekly arm (3-weekly  v  weekly, 49%  v  35% and 12%  v  7%, respectively), as were renal impairment and hearing impairment.","['postoperative high-risk locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN', 'patients with postoperative high-risk LA-SCCHN', 'Between October 2012 and December 2018, a total of 261 patients were enrolled (3-weekly cisplatin, 132 patients; weekly cisplatin, 129 patients', 'Postoperative Head and Neck Cancer (JCOG1008']","['chemoradiotherapy with 3-weekly cisplatin', 'chemoradiotherapy with weekly cisplatin', 'Chemoradiotherapy with weekly cisplatin', 'Weekly Cisplatin Plus Radiation', 'cisplatin']","['Grade 3 or more neutropenia and infection', 'proportion of treatment completion, and that of phase III was overall survival', 'renal impairment and hearing impairment', 'death', 'overall survival']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",261.0,0.0533021,"Grade 3 or more neutropenia and infection were less frequent in the weekly arm (3-weekly  v  weekly, 49%  v  35% and 12%  v  7%, respectively), as were renal impairment and hearing impairment.","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Kobe University Hospital, Cancer Center, Kobe, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kodaira', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Jichi Medical University Hospital, Shimotsuke, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Mitani', 'Affiliation': 'Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Shigemichi', 'Initials': 'S', 'LastName': 'Iwae', 'Affiliation': 'Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Fujimoto', 'Affiliation': 'Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Onozawa', 'Affiliation': 'Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Hanai', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takenori', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Saitama Cancer Center, Ina, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Monden', 'Affiliation': 'Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Shimura', 'Affiliation': 'Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Shujiro', 'Initials': 'S', 'LastName': 'Minami', 'Affiliation': 'National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Kindai University Hospital, Osakasayama, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Homma', 'Affiliation': 'Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Yoshimoto', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Oridate', 'Affiliation': 'Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Kyoto University Hospital Kyoto, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Okami', 'Affiliation': 'Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Ota', 'Affiliation': 'Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Kiyoto', 'Initials': 'K', 'LastName': 'Shiga', 'Affiliation': 'Iwate Medical University, Shiwa, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Sugasawa', 'Affiliation': 'Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Asakage', 'Affiliation': 'Tokyo Medical and Dental University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Murono', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Kindai University Hospital, Osakasayama, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Hayashi', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01293']
503,35236568,Tumour-infiltrating lymphocytes add prognostic information for patients with low-risk DCIS: findings from the SweDCIS randomised radiotherapy trial.,"BACKGROUND


The immune microenvironment is an important modulator of tumour progression and treatment response. In invasive breast cancer, assessment of tumour-infiltrating lymphocytes (TILs) provides prognostic and predictive information. However, the clinical impact of TILs for ductal carcinoma in situ (DCIS) has not yet been demonstrated.
PATIENTS AND METHODS


Post hoc analysis of the SweDCIS randomised radiotherapy trial including primary DCIS cases following breast-conserving surgery. TILs were assessed on haematoxylin-eosin sections (n = 711) according to the International Immuno-Oncology Biomarker Working Group guidelines. TILs-scores were analysed as continuous and dichotomised (≤5% versus >5%) variable regarding ipsilateral breast events (IBEs) as the predefined primary endpoint.
RESULTS


Most women (61.9%) showed a TILs prevalence of ≤5%. High TILs-scores were associated with larger lesion size, human epidermal growth factor receptor 2 (HER2)-positivity, higher nuclear grade, and KI67-score. DCIS cases with high TILs prevalence had a significant increased cumulative IBE incidence at five years post-surgery (TILs low -versus TILs high  9% versus 18%; p < 0.001). Among patients with HER2-negative DCIS, high TILs remained an independent poor prognosis marker for IBE risk in multivariable analysis with an adjusted hazard ratio of 2.41 [95%CI 1.17-4.95, p = 0.017]. Including TILs-status provided a refined stratification of patients with general low-risk DCIS (grade <3, size <25 mm, free margin). No interaction between TILs and radiotherapy benefits was detected.
CONCLUSION


High TILs are associated with higher IBE risk over 5-years post-surgery, particularly for HER2-negative DCIS. Our data indicate that TILs should be integrated into the clinical workup to define patients with low-risk DCIS who can omit adjuvant therapy or patients with potential benefits from immunotherapy.",2022,"High TILs-scores were associated with larger lesion size, human epidermal growth factor receptor 2 (HER2)-positivity, higher nuclear grade, and KI67-score.","['patients with low-risk DCIS', 'patients with low-risk DCIS who can omit adjuvant therapy or patients with potential benefits from immunotherapy', 'patients with general low-risk DCIS (grade <3, size <25\xa0mm, free margin']",['breast-conserving surgery'],"['IBE risk', 'cumulative IBE incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]","[{'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.13667,"High TILs-scores were associated with larger lesion size, human epidermal growth factor receptor 2 (HER2)-positivity, higher nuclear grade, and KI67-score.","[{'ForeName': 'Aglaia', 'Initials': 'A', 'LastName': 'Schiza', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Thurfjell', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Stenmark Tullberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Olofsson', 'Affiliation': 'Department of Pathology, Centre for Clinical Research of Uppsala University, Vastmanland´s Hospital Vasterås, Sweden.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lindberg', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Bremer', 'Affiliation': 'PreludeDx, Laguna Hills, CA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Micke', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Wärnberg', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Strell', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden. Electronic address: carina.strell@igp.uu.se.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.01.016']
504,35238476,Pharmacokinetics/pharmacodynamics of L-ornithine phenylacetate in overt hepatic encephalopathy and the effect of plasma ammonia concentration reduction on clinical outcomes.,"Hepatic encephalopathy (HE) is a serious neurocognitive complication of liver dysfunction, often associated with elevated plasma ammonia. Ornithine phenylacetate (OP), a potent ammonia scavenger, is being evaluated for the treatment of acute/overt HE. The pharmacokinetics and pharmacodynamics of OP in patients with HE were characterized in this phase IIb study (NCT01966419). Adult patients hospitalized with an overt HE episode, cirrhosis, and plasma ammonia above the upper limit of normal (ULN) who failed to improve after 48 hours' standard care were randomly assigned to continuous intravenous OP (10, 15, or 20 g/day, based on Child-Turcotte-Pugh score) or matching placebo for 5 days. Plasma levels of ornithine and phenylacetic acid (PAA) and plasma/urinary levels of phenylacetylglutamine (PAGN) (primary metabolite of PAA) were regularly assessed; plasma ammonia level was the primary pharmacodynamic variable. PAA demonstrated dose-dependent pharmacokinetics; ornithine and PAGN levels increased with dose. PAGN urinary excretion represented ~50%-60% of administered PAA across all doses. Mean reduction in plasma ammonia with OP at 3 hours postinfusion was significantly greater versus placebo (p = 0.014); and time to achieve plasma ammonia less than or equal to the ULN was significantly reduced (p = 0.028). Achievement of clinical response based on HE stage was associated with a greater reduction in mean plasma ammonia level (p = 0.009). OP effects on plasma ammonia were consistent with its proposed mechanism of action as a primary ammonia scavenger, with a significant association between reduced plasma ammonia and improvement in HE stage. OP should be further evaluated as a promising treatment for hyperammonemia in patients with overt HE.",2022,Achievement of clinical response based on HE stage was associated with a greater reduction in mean plasma ammonia level (p = 0.009).,"[""Adult patients hospitalized with an overt HE episode, cirrhosis, and plasma ammonia above the upper limit of normal (ULN) who failed to improve after 48\xa0hours' standard care"", 'patients with overt HE', 'patients with HE']","['continuous intravenous OP', 'Ornithine phenylacetate (OP', 'placebo', 'L-ornithine phenylacetate']","['PAGN urinary excretion', 'plasma ammonia level', 'plasma ammonia and improvement in HE stage', 'pharmacokinetics and pharmacodynamics of OP', 'mean plasma ammonia level', 'plasma ammonia', 'Mean reduction in plasma ammonia with OP', 'time to achieve plasma ammonia less', 'Plasma levels of ornithine and phenylacetic acid (PAA) and plasma/urinary levels of phenylacetylglutamine (PAGN) (primary metabolite of PAA', 'PAGN levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1278131', 'cui_str': 'Plasma ammonia measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3492240', 'cui_str': 'ornithine phenylacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0887117', 'cui_str': 'Ornithine, (L)-Isomer'}, {'cui': 'C0031452', 'cui_str': 'Benzeneacetates'}]","[{'cui': 'C0070627', 'cui_str': 'phenylacetylglutamine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1278131', 'cui_str': 'Plasma ammonia measurement'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C3492240', 'cui_str': 'ornithine phenylacetate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029277', 'cui_str': 'Ornithine'}, {'cui': 'C0070620', 'cui_str': 'Phenylacetic acid'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.150107,Achievement of clinical response based on HE stage was associated with a greater reduction in mean plasma ammonia level (p = 0.009).,"[{'ForeName': 'Rifaat', 'Initials': 'R', 'LastName': 'Safadi', 'Affiliation': 'Director of The Liver Institute, Hadassah Medical Organization, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rahimi', 'Affiliation': 'Baylor Scott and White Hospital, Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Thabut', 'Affiliation': 'Brain Liver Pitié-Salpêtrière (B-LIPS) Study Group, Paris Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Department of Medicine, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Kalyan', 'Initials': 'K', 'LastName': 'Ram Bhamidimarri', 'Affiliation': 'Miller School of Medicine, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pyrsopoulos', 'Affiliation': 'Rutgers New Jersey Medical School and University Hospital, Newark, New Jersey, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Potthoff', 'Affiliation': 'Ocera Therapeutics, Inc., Redwood City, California, USA.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Bukofzer', 'Affiliation': 'Ocera Therapeutics, Inc., Redwood City, California, USA.'}, {'ForeName': 'Laurene', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'INDAPharma, LLC, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Jamil', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, New Jersey, USA.'}, {'ForeName': 'Krishna R', 'Initials': 'KR', 'LastName': 'Devarakonda', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Webster Groves, Missouri, USA.'}]",Clinical and translational science,['10.1111/cts.13257']
505,35239416,Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial.,"PURPOSE


Both immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor receptor (VEGFR) inhibitors are approved for advanced renal cell carcinoma treatment and can cause cardiovascular events (CVs); thus, combination therapy could lead to major adverse CV events (MACE). Cardiac serum biomarker assessment and imaging, including left ventricular ejection fraction (LVEF) monitoring, can be used to evaluate MACE.
METHODS


To our knowledge, the JAVELIN Renal 101 trial, assessing avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma, is the first randomized study of ICI plus VEGFR inhibitor treatment to include prospective serial cardiac monitoring of LVEF and serum cardiac biomarkers.
RESULTS


MACE (defined as grade ≥ 3 CV AEs) occurred in 31 patients (7.1%) in the combination arm and 17 patients (3.9%) in the sunitinib arm. Patients in the combination arm who had high baseline troponin T values were at higher risk of MACE versus patients with low values (MACE in 6/35  v  7/135, respectively; relative risk, 3.31; 95% CI, 1.19 to 9.22). This association was not observed in patients treated with sunitinib. Other CV baseline risk factors and serum cardiac biomarkers were not significantly predictive for MACE, although a trend toward an association with dyslipidemia was seen in the combination arm. No clinical value of on-treatment routine monitoring of LVEF in relation to MACE was observed. Although LVEF decline was significantly more frequent in the combination arm, most patients recovered, and decline was not associated with other significant cardiac events or symptoms.
CONCLUSION


Patients with high baseline troponin T levels receiving ICI and VEGFR combinations may need to be monitored more closely for MACE. Routine monitoring of LVEF in asymptomatic patients is not recommended.",2022,"Other CV baseline risk factors and serum cardiac biomarkers were not significantly predictive for MACE, although a trend toward an association with dyslipidemia was seen in the combination arm.","['asymptomatic patients', 'Patients With Advanced Renal Cell Cancer', 'patients with advanced renal cell carcinoma']","['immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor receptor (VEGFR) inhibitors', 'avelumab plus axitinib versus sunitinib', 'Immune Checkpoint Inhibitor-Based Combination Therapy', 'ICI plus VEGFR inhibitor']","['LVEF decline', 'CV baseline risk factors and serum cardiac biomarkers', 'high baseline troponin T values']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0291669,"Other CV baseline risk factors and serum cardiac biomarkers were not significantly predictive for MACE, although a trend toward an association with dyslipidemia was seen in the combination arm.","[{'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Javid J', 'Initials': 'JJ', 'LastName': 'Moslehi', 'Affiliation': 'Section of Cardio-Oncology & Immunology, Division of Cardiology, Cardiovascular Research Institute, University of California San Francisco School of Medicine, San Francisco, CA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonaca', 'Affiliation': 'Colorado Prevention Center Clinical Research, Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Schmidinger', 'Affiliation': 'Department of Urology and Comprehensive Cancer Center, Medical University of Vienna, Waehringer Guertel, Vienna, Austria.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Medical Oncology Department, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Mariani', 'Affiliation': 'Oncology Research Unit, Pfizer srl, Milano, Italy.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Statistics, Pfizer, Cambridge, MA.'}, {'ForeName': 'Subramanian', 'Initials': 'S', 'LastName': 'Hariharan', 'Affiliation': 'Oncology, Pfizer, New York, NY.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01806']
506,35254888,"Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin or Gemcitabine and Cisplatin as Perioperative Chemotherapy for Patients With Nonmetastatic Muscle-Invasive Bladder Cancer: Results of the GETUG-AFU V05 VESPER Trial.","PURPOSE


The optimal perioperative chemotherapy regimen for patients with nonmetastatic muscle-invasive bladder cancer is not defined.
PATIENTS AND METHODS


Between February 2013 and March 2018, 500 patients were randomly assigned in 28 French centers and received either six cycles of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) once every 2 weeks or four cycles of gemcitabine and cisplatin (GC) once every 3 weeks before surgery (neoadjuvant group) or after surgery (adjuvant group). We report the primary end point of the GETUG-AFU V05 VESPER trial (ClinicalTrials.gov identifier: NCT01812369): progression-free survival (PFS) at 3 years. Secondary end points were time to progression and overall survival.
RESULTS


Four hundred thirty-seven patients (88%) received neoadjuvant chemotherapy; 60% of patients received the planned six cycles in the dd-MVAC arm, 84% received four cycles in the GC arm, and thereafter, 91% and 90% of patients underwent surgery, respectively. Organ-confined response (< ypT3N0) was observed more frequently in the dd-MVAC arm (77%  v  63%,  P  = .001). In the adjuvant group, 40% of patients received six cycles in the dd-MVAC arm, and 81% of patients received four cycles in the GC arm. For all patients in the clinical trial, 3-year PFS was improved in the dd-MVAC arm, but the study did not meet its primary end point (3-year rate: 64%  v  56%, hazard ratio [HR] = 0.77 [95% CI, 0.57 to 1.02],  P  = .066); nevertheless, the dd-MVAC arm was associated with a significantly longer time to progression (3-year rate: 69%  v  58%, HR = 0.68 [95% CI, 0.50 to 0.93],  P  = .014). In the neoadjuvant group, PFS at 3 years was significantly higher in the dd-MVAC arm (66%  v  56%, HR = 0.70 [95% CI, 0.51 to 0.96],  P  = .025).
CONCLUSION


In the VESPER trial, dd-MVAC improved 3-years PFS over GC. In the neoadjuvant group, a better bladder tumor local control and a significant improvement in 3-year PFS were observed in the dd-MVAC arm.",2022,"In the neoadjuvant group, a better bladder tumor local control and a significant improvement in 3-year PFS were observed in the dd-MVAC arm.","['500 patients were randomly assigned in 28 French centers and received either', 'patients with nonmetastatic muscle-invasive bladder cancer', 'Between February 2013 and March 2018', 'Patients With Nonmetastatic Muscle-Invasive Bladder Cancer']","['Methotrexate, Vinblastine, Doxorubicin, and Cisplatin or Gemcitabine and Cisplatin', 'six cycles of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC', 'neoadjuvant chemotherapy', 'gemcitabine and cisplatin (GC']","['longer time to progression', 'progression-free survival (PFS', '3-year PFS', 'time to progression and overall survival']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0065452', 'cui_str': 'M-VAC protocol'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",500.0,0.110737,"In the neoadjuvant group, a better bladder tumor local control and a significant improvement in 3-year PFS were observed in the dd-MVAC arm.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pfister', 'Affiliation': 'Department of Urology, Charles Nicolle University Hospital, Rouen, France.'}, {'ForeName': 'Gwenaelle', 'Initials': 'G', 'LastName': 'Gravis', 'Affiliation': 'Department of Medical Oncology, Paoli-Calmette Institute, Marseille, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Fléchon', 'Affiliation': 'Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': 'Department of Medical Oncology, ICR-IUCT Oncopole, Toulouse, France.'}, {'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Mahammedi', 'Affiliation': 'Department of Medical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Laguerre', 'Affiliation': 'Department of Medical Oncology, Eugène Marquis Cancer Center, Rennes, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Guillot', 'Affiliation': 'Department of Medical Oncology, Lucien Neuwirth Cancer Institute, St Priest, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Department of Medical Oncology, Baclesse Cancer Center, Caen, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Soulié', 'Affiliation': 'Department of Urology, Rangueil University Hospital, Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Allory', 'Affiliation': 'Department of Pathology, Curie Institute, Saint-Cloud, France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Harter', 'Affiliation': 'North-West Canceropole Data Center, Baclesse Cancer Center, Caen, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Culine', 'Affiliation': 'Department of Medical Oncology, Saint-Louis Hospital, AP-HP, Faculté de Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.02051']
507,35552386,Physical properties of root cementum: Part 29. The effects of LED-mediated photobiomodulation on orthodontically induced root resorption and pain: a pilot split-mouth randomized controlled trial.,"OBJECTIVES


To examine the effects of light-emitting diode (LED)-mediated photobiomodulation (PBM) on orthodontic root resorption and pain.
METHODS


Twenty patients (3 males, 17 females, mean age 15 years 6 months) needing bilateral maxillary first premolar extractions for orthodontic treatment were included in this single-centre, split-mouth randomized controlled trial. Both premolars received 150 g of buccal tipping force for 28 days. One side was randomly assigned to receive intraoral 850 nm wavelength, 60 mW/cm2 power, continuous LED illumination via OrthoPulse device (Biolux Research Ltd, Vancouver, British Columbia, Canada) for 5 minutes/day. The other side served as control. After 28 days, both premolars were extracted and scanned with micro-computed tomography for primary outcome assessment of root resorption crater volume measurements. For secondary outcome assessment, visual analogue scale pain questionnaires were used for both sides at 24 hours, 48 hours, 72 hours, and 7 days. Randomization was generated using www.randomization.com and allocation was concealed in sequentially numbered, opaque, sealed envelopes. Blinding was not possible during the experiment due to the use of tape to block light on control side of the devices. Assessors were blinded during outcome assessments.
RESULTS


All 40 premolars from 20 patients were included. There was no significant difference in the mean total root resorption between the LED PBM and control sides (mean 0.216 versus 0.284 mm3, respectively, P = 0.306). The LED side was associated with less pain at 24 hours (P = 0.023) and marginally more pain at subsequent time points, which was not statistically significant. No harms were observed.
LIMITATIONS


Short study duration and the inability to blind patients and clinician during clinical part of study.
CONCLUSION


This 28-day randomized split-mouth controlled trial showed that daily, LED-mediated PBM application, when applied for 5 minute/day, does not influence orthodontic root resorption. It is associated with significantly less pain 24 hours after the application of orthodontic force, but no difference thereafter. These results should be tested on patients undergoing a full course of orthodontic treatment.
TRIAL REGISTRATION


Clinical Trials Registry ACTRN12616000652471.",2022,"The LED side was associated with less pain at 24 hours (P = 0.023) and marginally more pain at subsequent time points, which was not statistically significant.","['patients undergoing a full course of orthodontic treatment', 'All 40 premolars from 20 patients were included', 'Twenty patients (3 males, 17 females, mean age 15 years 6 months) needing bilateral maxillary first premolar extractions for orthodontic treatment']","['LED-mediated PBM application', 'LED-mediated photobiomodulation', 'light-emitting diode (LED)-mediated photobiomodulation (PBM']","['visual analogue scale pain questionnaires', 'root resorption crater volume measurements', 'pain', 'mean total root resorption', 'root resorption and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",20.0,0.25776,"The LED side was associated with less pain at 24 hours (P = 0.023) and marginally more pain at subsequent time points, which was not statistically significant.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sambevski', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Sydney Local Health District, NSW, Australia.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Papadopoulou', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Sydney Local Health District, NSW, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Foley', 'Affiliation': 'Australian Centre for Microscopy and Microanalysis, The University of Sydney, NSW, Australia.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Dalci', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Sydney Local Health District, NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Petocz', 'Affiliation': 'Department of Statistics, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Mehmet Ali', 'Initials': 'MA', 'LastName': 'Darendeliler', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Sydney Local Health District, NSW, Australia.'}, {'ForeName': 'Oyku', 'Initials': 'O', 'LastName': 'Dalci', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Sydney Local Health District, NSW, Australia.'}]",European journal of orthodontics,['10.1093/ejo/cjac022']
508,35238614,Therapeutic Phlebotomy in Patients with Grade 1 Hypertension: A Randomized-Controlled Trial.,"Aim:  Study aim was to investigate the effects of therapeutic phlebotomy on ambulatory blood pressure in patients with grade 1 hypertension.  Methods:  In this randomized-controlled intervention study, patients with unmedicated hypertension grade 1 were randomized into an intervention group (phlebotomy group; 500 mL bloodletting at baseline and after 6 weeks) and a control group (waiting list) and followed up for 8 weeks. Primary endpoint was the 24-h ambulatory mean arterial pressure between the intervention and control groups after 8 weeks. Secondary outcome parameters included ambulatory/resting systolic/diastolic blood pressure, heart rate, and selected laboratory parameters (e.g., hemoglobin, hematocrit, erythrocytes, and ferritin). Resting systolic/diastolic blood pressure/heart rate and blood count were also assessed at 6 weeks before the second phlebotomy to ensure safety. A per-protocol analysis was performed.  Results:  Fifty-three hypertension participants (56.7 ± 10.5 years) were included in the analysis ( n  = 25 intervention group,  n  = 28 control group). The ambulatory measured mean arterial pressure decreased by -1.12 ± 5.16 mmHg in the intervention group and increased by 0.43 ± 3.82 mmHg in the control group (between-group difference: -1.55 ± 4.46,  p  = 0.22). Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences. Subgroup analysis showed trends regarding the effects on different groups classified by serum ferritin concentration, body mass index, age, and sex. Two adverse events (AEs) (anemia and dizziness) occurred in association with the phlebotomy, but no serious AEs.  Conclusions:  Study results showed that therapeutic phlebotomy resulted in only minimal reductions of 24-h ambulatory blood pressure measurement values in patients with unmedicated grade 1 hypertension. Further high-quality clinical studies are warranted, as this finding contradicts the results of other studies.",2022,"Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences.","['Patients with Grade 1 Hypertension', 'Results:  Fifty-three hypertension participants (56.7\u2009±\u200910.5 years) were included in the analysis ( n \u2009=\u200925 intervention group,  n \u2009=\u200928 control group', 'patients with grade 1 hypertension', 'patients with unmedicated grade 1 hypertension', 'patients with unmedicated hypertension grade 1']","['intervention group (phlebotomy group; 500\u2009mL bloodletting at baseline and after 6 weeks) and a control group (waiting list', 'Therapeutic Phlebotomy', 'therapeutic phlebotomy']","['ambulatory measured mean arterial pressure', '24-h ambulatory mean arterial pressure', 'ambulatory/resting systolic/diastolic blood pressure, heart rate, and selected laboratory parameters (e.g., hemoglobin, hematocrit, erythrocytes, and ferritin', 'serum ferritin concentration, body mass index, age, and sex', 'Hemoglobin, hematocrit, erythrocytes, and ferritin', '24-h ambulatory blood pressure measurement values', 'Resting systolic/diastolic blood pressure/heart rate and blood count', 'ambulatory blood pressure', 'adverse events (AEs) (anemia and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0005857', 'cui_str': 'Therapeutic phlebotomy'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",,0.0291995,"Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jeitler', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Roth', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Steckhan', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Meier', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Koppold-Liebscher', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Farid I', 'Initials': 'FI', 'LastName': 'Kandil', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ostermann', 'Affiliation': 'Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stange', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Kessler', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Benno', 'Initials': 'B', 'LastName': 'Brinkhaus', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michalsen', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}]",Journal of integrative and complementary medicine,['10.1089/jicm.2021.0396']
509,35240925,"Public engagement during a typhoid conjugate vaccine trial in Lalitpur, Nepal- experience, challenges and lessons learnt.","Typhoid is a public health problem in Nepal. To generate evidence on the impact of Typhoid Conjugate Vaccine (TCV), a phase 3, double-blind, randomized controlled trial was conducted in Lalitpur, Nepal. 20,000 children aged between 9 months and ≤16 years were vaccinated with a new TCV, or control vaccine. Participants were actively followed for safety and efficacy over 2 years through passive surveillance (PS) clinics. Several challenges were encountered during vaccination and PS stemming from misinformation, misconception, and fear around clinical trials in the community. Public engagement (PE) activities were conducted across various tiers moving from decision makers in the first tier; to elected local representatives in the second tier; ending with interaction in community with parents/guardians of the targeted population. Prior and during vaccination, engagement was conducted to inform about the study and discuss the importance of vaccination. Post-vaccination, engagement was conducted to inform about PS clinics, alleviate study concerns and share study updates. Direct and continuous interaction with community stakeholders, including parents/guardians of the targeted population contributed to build trust around the study and community willingness to be involved. It helped to raise awareness, drive away misconceptions, and allowed adaptation according to feedback from community members.",2022,"20,000 children aged between 9 months and ≤16 years were vaccinated with a new TCV, or control vaccine.","['20,000 children aged between 9\u2009months and ≤16\u2009years were vaccinated with a']","['new TCV, or control vaccine', 'Typhoid Conjugate Vaccine (TCV']","['safety and efficacy', 'Public engagement (PE) activities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",20000.0,0.391341,"20,000 children aged between 9 months and ≤16 years were vaccinated with a new TCV, or control vaccine.","[{'ForeName': 'Ashata', 'Initials': 'A', 'LastName': 'Dahal', 'Affiliation': 'Patan Academy of Health Sciences, Oxford University Clinical Research Unit-Nepal, Lalitpur, Nepal.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Shakya', 'Affiliation': 'Patan Academy of Health Sciences, Oxford University Clinical Research Unit-Nepal, Lalitpur, Nepal.'}, {'ForeName': 'Dikshya', 'Initials': 'D', 'LastName': 'Pant', 'Affiliation': 'Department of Paediatrics, Patan Academy of Health Sciences, Lalitpur, Nepal.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Adhikari', 'Affiliation': 'Nepal Family Development Foundation, Lalitpur, Nepal.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Colin-Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Theiss-Nyland', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Buddha', 'Initials': 'B', 'LastName': 'Basnyat', 'Affiliation': 'Patan Academy of Health Sciences, Oxford University Clinical Research Unit-Nepal, Lalitpur, Nepal.'}, {'ForeName': 'Shrijana', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Department of Paediatrics, Patan Academy of Health Sciences, Lalitpur, Nepal.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2043104']
510,35246330,Assessment of the short-term outcomes of laparoscopic gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer: A prospective single-armed clinical trial.,"BACKGROUND


Laparoscopic surgical approaches for gastric cancer after neoadjuvant chemotherapy are increasing, yet there is limited evidence of their safety and effectiveness.
METHODS


This prospective single-armed clinical trial enrolled 80 neoadjuvant chemotherapy patients who underwent laparoscopic gastrectomy. In addition, to better analyze the outcomes of this study, 1:2 propensity score matching was performed, and a contemporaneous historic control group containing 160 laparoscopic gastrectomy patients without neoadjuvant chemotherapy was established.
RESULTS


Analyses were performed to compare the neoadjuvant chemotherapy group (n = 80) and the control group (n = 160). The general clinical data of both groups were comparable. The neoadjuvant chemotherapy group showed less intraoperative bleeding (P = .029) and recovered more quickly than the control group (all P < .05). The 2 groups did not exhibit major differences in terms of postoperative complications (P = .679) or severe complications (P = .055). The proportion of patients with ypT4 stage and ypN3 stage disease in the neoadjuvant chemotherapy group totaled 20.7% and 23.8%, respectively, which was significantly lower than that observed in the control group (P < .05). The number of metastatic lymph nodes was 4.8 ± 7.0 in the neoadjuvant chemotherapy group, which was lower than that in the control group (P < .001). In the neoadjuvant chemotherapy group, the major pathological regression rate was 27.5%, while the objective radiologic response rate (complete response + partial response) was 64.0%. In contrast to nonresponding patients, the patients who experienced an objective response had a shorter operation time (P < .001), less intraoperative bleeding (P < .001), and fewer metastatic lymph nodes (P = .005). The short-term effects observed in the nonresponding patients were similar to those observed in the control group.
CONCLUSION


Laparoscopic gastrectomy could achieve improved short-term outcomes through NACT tumor downstaging without increasing the incidence of postoperative complications. Further multicenter and prospective clinical trials are warranted.",2022,The 2 groups did not exhibit major differences in terms of postoperative complications (P = .679) or severe complications (P = .055).,"['locally advanced gastric cancer', '80 neoadjuvant chemotherapy patients who underwent', '160 laparoscopic gastrectomy patients without']","['laparoscopic gastrectomy', 'neoadjuvant chemotherapy', 'laparoscopic gastrectomy after neoadjuvant chemotherapy', 'Laparoscopic gastrectomy']","['objective radiologic response rate', 'shorter operation time', 'severe complications', 'major pathological regression rate', 'intraoperative bleeding', 'postoperative complications', 'metastatic lymph nodes', 'number of metastatic lymph nodes', 'proportion of patients with ypT4 stage and ypN3 stage disease']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",80.0,0.0525409,The 2 groups did not exhibit major differences in terms of postoperative complications (P = .679) or severe complications (P = .055).,"[{'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ze-Ning', 'Initials': 'ZN', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ju-Li', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua-Long', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China. Electronic address: hcmlr2002@163.com.'}]",Surgery,['10.1016/j.surg.2022.01.015']
511,35248212,Safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trial.,"BACKGROUND


Hepatitis C virus (HCV) genotype 4 non-a/d subtypes, which frequently have NS5A resistance-associated substitutions, are highly prevalent in sub-Saharan Africa. These subtypes, particularly genotype 4r, have been associated with higher rates of failure of treatment regimens containing the NS5A inhibitors ledipasvir or daclatasvir, which are the most accessible direct-acting antivirals in low-income countries. Clinical evidence regarding the efficacy of re-treatment options for these subtypes is limited. We aimed to evaluate the safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for the treatment of adults in Rwanda with chronic HCV infection, predominantly of genotype 4, and a history of direct-acting antiviral treatment failure.
METHODS


In this single-arm prospective trial, we enrolled adults (aged ≥18 years) with a HCV RNA titre of at least 1000 IU/mL, and a documented history of direct-acting antiviral failure. Patients were assessed for eligibility at a single study site after referral from hospitals with HCV treatment programmes throughout Rwanda, and participants for whom sofosbuvir-ledipasvir treatment had failed in the previous SHARED trial were also included. Participants with decompensated liver disease or hepatitis B virus co-infection were excluded. Participants were treated once daily with an oral fixed-dose combination tablet containing sofosbuvir (400 mg), velpatasvir (100 mg), and voxilaprevir (100 mg) for 12 weeks. The primary endpoint was the proportion of participants with a sustained virological response 12 weeks after completion of treatment (SVR12) in the intention-to-treat population. Viral sequencing of NS3, NS5A, and NS5B genes was done at baseline in all participants and at end of follow-up (week 24) in participants with treatment failure. The study is registered with ClinicalTrials.gov (NCT03888729) and is completed.
FINDINGS


Between Sept 23, 2019, and Jan 10, 2020, 49 individuals were screened and 40 participants were enrolled. 20 (50%) were female, 20 (50%) were male, median age was 63 years (IQR 56-68), and median HCV viral load was 6·2 log 10  IU/mL (5·8-6·5) at baseline. The genotype subtypes identified were 4r (18 [45%] participants), 4k (six [15%]), 4b (five [13%]), 4q (four [10%]), 4l (two [5%]), 4a (one [3%]), 4m (one [3%]), and 3h (one [3%]). One (3%) genotype 4 isolate could not be subtyped, and one (3%) isolate was of unknown genotype. All successfully sequenced isolates (33 [83%]) had at least two NS5A resistance-associated substitutions and 25 (63%) had three or more. 39 (98% [95% CI 87-100]) participants had SVR12. Seven (18%) participants had a total of ten grade 3, 4, or 5 adverse events, including three (8%) cases of hypertension, and one (3%) case each of cataract, diabetes, gastrointestinal bleeding, joint pain, low back pain, vaginal cancer, and sudden death. Four of these events were categorised as serious adverse events resulting in hospitalisation. The one sudden death occurred at home from an unknown cause 4 weeks after the completion of treatment. No serious adverse event was determined to be related to the study drug or resulted in treatment discontinuation.
INTERPRETATION


A 12 week course of sofosbuvir-velpatasvir-voxilaprevir is safe and efficacious for the re-treatment of individuals infected with HCV genotype 4 non-a/d subtypes with frequent baseline NS5A resistance-associated substitutions, following failure of previous direct-acting antiviral treatment. Improved affordability and access to sofosbuvir-velpatasvir-voxilaprevir in regions with these subtypes is crucial.
FUNDING


Gilead Sciences.",2022,"Viral sequencing of NS3, NS5A, and NS5B genes was done at baseline in all participants and at end of follow-up (week 24) in participants with treatment failure.","['adults in Rwanda with chronic HCV infection, predominantly of genotype 4, and a history of direct-acting antiviral treatment failure', '39', 'Patients were assessed for eligibility at a single study site after referral from hospitals with HCV treatment programmes throughout Rwanda, and participants for whom sofosbuvir-ledipasvir treatment had failed in the previous SHARED trial were also included', 'patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3', 'Between Sept 23, 2019, and Jan 10, 2020, 49 individuals were screened and 40 participants were enrolled', 'enrolled adults (aged ≥18 years) with a HCV RNA titre of at least 1000 IU/mL, and a documented history of direct-acting antiviral failure', 'Participants with decompensated liver disease or hepatitis B virus co-infection were excluded', '20 (50%) were female, 20 (50%) were male, median age was 63 years ']","['velpatasvir (100 mg), and voxilaprevir', 'sofosbuvir-velpatasvir-voxilaprevir']","['median HCV viral load', 'safety and efficacy', 'cataract, diabetes, gastrointestinal bleeding, joint pain, low back pain, vaginal cancer, and sudden death', 'proportion of participants with a sustained virological response', 'sudden death']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3851350', 'cui_str': 'ledipasvir'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019159', 'cui_str': 'Viral hepatitis, type A'}, {'cui': 'C0035691', 'cui_str': 'RNA virus'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4079582', 'cui_str': 'velpatasvir'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4507236', 'cui_str': 'voxilaprevir'}, {'cui': 'C4271578', 'cui_str': 'sofosbuvir and velpatasvir'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0042237', 'cui_str': 'Malignant tumor of vagina'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]",49.0,0.523687,"Viral sequencing of NS3, NS5A, and NS5B genes was done at baseline in all participants and at end of follow-up (week 24) in participants with treatment failure.","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': ""Partners In Health, Boston, MA, USA; Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA; Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: ngupta@pih.org.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Manirambona', 'Affiliation': 'Partners In Health, Rwinkwavu, Rwanda.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Shumbusho', 'Affiliation': 'Partners In Health, Rwinkwavu, Rwanda.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Kabihizi', 'Affiliation': 'Rwanda Military Hospital, Kanombe, Rwanda.'}, {'ForeName': 'Anthere', 'Initials': 'A', 'LastName': 'Murangwa', 'Affiliation': 'Rwanda Military Hospital, Kanombe, Rwanda.'}, {'ForeName': 'Janvier', 'Initials': 'J', 'LastName': 'Serumondo', 'Affiliation': 'Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Jean Damascene', 'Initials': 'JD', 'LastName': 'Makuza', 'Affiliation': 'Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Nsanzimana', 'Affiliation': 'Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Claude Mambo', 'Initials': 'CM', 'LastName': 'Muvunyi', 'Affiliation': 'College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Mukabatsinda', 'Affiliation': 'College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Musabeyezu', 'Affiliation': 'King Faisal Hospital, Kigali, Rwanda.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Camus', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Grant', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Kateera', 'Affiliation': 'Partners In Health, Rwinkwavu, Rwanda.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(21)00399-X']
512,35253453,"A dynamic and collaborative approach to trial recruitment in safetxt, a UK sexual health randomised controlled trial.","BACKGROUND/AIMS


Recruiting to target in randomised controlled trials is crucial for providing reliable results, yet many trials struggle to achieve their target sample size. Many trials do not report sufficient, if any, details of their recruitment strategy for others to adapt for their own trials. Furthermore, much of the available evidence describes strategies to improve recruitment aimed at participants, as opposed to strategies aimed at engaging and motivating recruiting staff who are deemed essential for recruitment success. The safetxt trial aimed to recruit 6250 participants, aged 16-24 years, who had either tested positive, or received treatment, for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks, from across the United Kingdom into a randomised controlled trial investigating a text message intervention to improve sexual health outcomes. In this article, we describe in detail the recruitment strategies we employed that were primarily aimed at recruiters.
METHODS


Recruitment began in April 2016. We built on our recruitment methods established in the pilot trial and developed several strategies to increase recruitment as the trial progressed including optimising site set-up, monitoring recruitment progress and identifying issues, facilitating shared learning, tailored recruitment materials, sustaining motivation, and communication. We describe these strategies in detail and provide practical examples for each.
RESULTS


We combine our strategies for increasing recruitment into one cyclical approach whereby progress is continuously monitored, and interventions to improve recruitment are implemented. The site initiation visits were used to develop a clear recruitment plan and establish good relationships with local site staff. Screening logs were particularly helpful for monitoring recruitment challenges. We facilitated shared learning by organising meetings with recruiting sites and conducting site visits. Tailored recruitment materials helped to promote the trial in clinic environments, and rewards and goals helped sustain motivation among recruiting staff. Finally, at the centre of the approach is good communication which ensured we maintained good relationships with local site staff.
CONCLUSION


We conducted a large, multi-centre trial and successfully recruited to target. Our dynamic collaborative approach to recruitment described in this paper builds upon previous research by combining suggested good practice into one cyclical approach to recruitment, and providing detailed examples of each strategy. It is not possible to attribute a causal link between our approach and recruitment success overall, or with specific sites or recruiting staff. Nonetheless we describe the processes we used to build a good relationship with recruiting staff and sites, and maintain recruitment of large numbers of participants over the 32 months of the trial. Other researchers can use our approach and adapt our examples for their own trials.",2022,"It is not possible to attribute a causal link between our approach and recruitment success overall, or with specific sites or recruiting staff.","['Recruitment began in April 2016', '6250 participants, aged 16-24 years, who had either tested positive, or received treatment, for chlamydia/gonorrhoea/non-specific urethritis in the last 2 weeks']",['text message intervention'],['sexual health outcomes'],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0311389', 'cui_str': 'Nonspecific urethritis'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",6250.0,0.244295,"It is not possible to attribute a causal link between our approach and recruitment success overall, or with specific sites or recruiting staff.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Jerome', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ona', 'Initials': 'O', 'LastName': 'McCarthy', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Palmer', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Knight', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}]","Clinical trials (London, England)",['10.1177/17407745221078882']
513,35258154,Prevalence of disability improvement in relapsing-remitting multiple sclerosis patients treated with cladribine tablets.,"BACKGROUND AND PURPOSE


The aim was to show the application of the prevalence estimator of Expanded Disability Status Scale (EDSS) improvement over time in patients treated with cladribine tablets in the phase III CLARITY/CLARITY extension trials.
METHODS


Relapsing-remitting multiple sclerosis patients who entered the CLARITY extension study were evaluated. Patients originally randomized in CLARITY to cladribine tablets 3.5 mg/kg and placebo in CLARITY extension (early cladribine [EC]) were compared to patients originally randomized to placebo and then assigned to cladribine tablets 3.5 mg/kg (delayed cladribine [DC]). The EC group was compared to the DC group on the prevalence of EDSS improvement over time and on the cumulative incidence of EDSS improvement. Prevalence of improvement was assessed by a new approach based on the difference of Kaplan-Meier estimators, whilst the incidence of improvement was assessed by standard Kaplan-Meier curves.
RESULTS


A total of 98 patients in the EC group and 244 patients in the DC group were compared. Patients in the EC group showed a significantly higher (p = 0.011) prevalence of improvement at year 2 (EC 21.3%, 95% confidence interval [CI] 13.6-29.3; DC 8.9%, 95% CI 5.5-12.8) and at year 5 (EC 15.7%, 95% CI 8.2-23.7; DC 8.3%, 95% CI 4.5-12.4). The cumulative incidence of improvement was also significantly different (hazard ratio 1.82, 95% CI 1.13-2.94, p = 0.013).
CONCLUSIONS


Assessment of the prevalence of EDSS improvement is an alternative outcome to assess if a treatment induces and maintains an improvement over the long term. This estimator was found to be more powerful than the cumulative incidence of improvement to detect a treatment effect of cladribine versus placebo over 5 years.",2022,"Patients in the EC group showed a significantly higher (p=0.011) prevalence of improvement at year 2: EC 21.3% [95%CI 13.6-29.3], DC 8.9% [95%CI 5.5-12.8]; and at year 5: EC 15.7% [95%CI 8.2-23.7], DC 8.3% [95%CI 4.5-12.4]).","['relapsing-remitting MS patients who entered the CLARITY Extension study', 'relapsing-remitting multiple sclerosis patients treated with', '98 patients in the EC group and 244 patients in the DC group']","['placebo', 'cladribine vs placebo', 'placebo in CLARITY Extension (Early Cladribine [EC', 'EC', 'cladribine tablets 3.5 mg/kg (Delayed Cladribine [DC', 'cladribine', 'cladribine tablets']","['cumulative incidence of improvement', 'Kaplan-Meier (KM) estimators', 'disability improvement']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517660', 'cui_str': '244'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0401805', 'cui_str': 'Estimator'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.057787,"Patients in the EC group showed a significantly higher (p=0.011) prevalence of improvement at year 2: EC 21.3% [95%CI 13.6-29.3], DC 8.9% [95%CI 5.5-12.8]; and at year 5: EC 15.7% [95%CI 8.2-23.7], DC 8.3% [95%CI 4.5-12.4]).","[{'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Signori', 'Affiliation': 'Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ponzano', 'Affiliation': 'Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Nektaria', 'Initials': 'N', 'LastName': 'Alexandri', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.'}]",European journal of neurology,['10.1111/ene.15316']
514,35259523,Towards a mechanistic understanding of mindfulness-based stress reduction (MBSR) using an RCT neuroimaging approach: Effects on regulating own stress in social and non-social situations.,"Although much research has shown that mindfulness-based interventions (MBIs) can reduce psychological stress, it is less clear if effects generalize to everyday social situations, which range among the largest stress triggers. Furthermore, mechanisms of MBIs have not been fully established. Emotion regulation (ER) has been suggested as one key mechanism, yet the role of cognitive reappraisal and acceptance strategies is still under debate. To address these questions, a neuroimaging-based randomized controlled trial (RCT) was performed (n=68), comparing mindfulness-based stress reduction (MBSR) with a reading/listening intervention (READ), using a novel dyadic paradigm for self and other emotion regulation under stress as primary outcome on behavior and brain levels and established empathy measures (clinicatrials.gov NCT03035669). Compared to READ, MBSR led to self-reported stress reduction through both cognitive reappraisal and acceptance only when regulating self and not when regulating others' distress. In addition, MBSR led to increased brain activation over time for regulating own (parietal cortex) and others' (precuneus, TPJ) emotions through cognitive reappraisal and acceptance, albeit this effect was also seen for the reading intervention for regulating own stress via reappraisal. Brain changes did not scale with subjective stress reduction and amount of meditation practice. More distant generalization effects of MBSR on socio-emotional functioning (cognitive empathy and compassion) could also not be shown. This study identified both cognitive reappraisal and acceptance as two ER mechanisms of MBSR, but indicates that effects do not extend to social settings.",2022,"Compared to READ, MBSR led to self-reported stress reduction through both cognitive reappraisal and acceptance only when regulating self and not when regulating others' distress.",[],"['MBSR', 'Emotion regulation (ER', 'mindfulness-based stress reduction (MBSR) with a reading/listening intervention (READ), using a novel dyadic paradigm for self and other emotion regulation']","['brain activation', 'behavior and brain levels and established empathy measures', 'socio-emotional functioning (cognitive empathy and compassion']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",,0.030676,"Compared to READ, MBSR led to self-reported stress reduction through both cognitive reappraisal and acceptance only when regulating self and not when regulating others' distress.","[{'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Guendelman', 'Affiliation': 'Clinical Psychology of Social Interaction, Berlin School of Mind and Brain, Institute of Psychology. Humboldt-Universität zu Berlin, Unter den Linden 6, 10117, Berlin, Germany. Electronic address: simon.guendelman@hu-berlin.de.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Bayer', 'Affiliation': 'Clinical Psychology of Social Interaction, Berlin School of Mind and Brain, Institute of Psychology. Humboldt-Universität zu Berlin, Unter den Linden 6, 10117, Berlin, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Prehn', 'Affiliation': 'Department of Psychology, MSH Medical School Hamburg - University of Applied Sciences and Medical University, Am Kaiserkai 1, 20457 Hamburg, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Dziobek', 'Affiliation': 'Clinical Psychology of Social Interaction, Berlin School of Mind and Brain, Institute of Psychology. Humboldt-Universität zu Berlin, Unter den Linden 6, 10117, Berlin, Germany.'}]",NeuroImage,['10.1016/j.neuroimage.2022.119059']
515,35218191,"Metabolic Availability of Methionine Assessed Using Indicator Amino Acid Oxidation Method, Is Greater when Cooked Lentils and Steamed Rice Are Combined in the Diet of Healthy Young Men.","BACKGROUND


Lentil is considered a high protein source. However, it is low in sulphur amino acids (SAA) and their metabolic availability (MA) is further affected by antinutritional factors in lentils. The combination of lentils with grains such as rice can enhance the protein quality of a lentil-based meal but the MA of SAA in lentils must first be known.
OBJECTIVES


The objectives of the current study were to assess the MA of methionine in lentils and to test the effects of consumption of complementing lentils with rice in young adults.
METHODS


Five healthy young men [age <30 y, BMI <25 (in kg/m2)] were each studied at 8 or 10 intake amounts of methionine in random order; 4 daily intake amounts of l-methionine: 0.5, 1, 2, and 3 mg.kg-1.d-1 (reference diet), 3 daily intake amounts of methionine from lentils, and 3 daily intake amounts of the mixed meal of lentils + rice (test diets). The MA of methionine and the effects of complementation were assessed by comparing the indicator amino acid oxidation (IAAO) response to varying intakes of methionine in cooked Canadian lentils, and in rice + lentils combined, compared with the IAAO response to l-methionine intakes in the reference protein (crystalline AA mixture patterned after egg protein) using the slope ratio method. l-[1-13C] phenylalanine was used as the indicator. Data were analyzed using the procedure ""MIXED"" with subject as a random variable, and oxidation day as repeated measure.
RESULTS


The MA of methionine from lentils was 69%. Complementation of cooked lentils with rice decreased the oxidation of l-[1-13C] phenylalanine by up to 16% (P < 0.05).
CONCLUSIONS


The content and MA of methionine are low in lentils. However, combination of lentils with rice in a 1:1 ratio can improve the protein quality of lentil-based diets, resulting in increased protein synthesis in young healthy adults. This trial was registered at www.clinical trials.gov as NCT03110913.",2022,"Complementation of cooked lentils with rice decreased the oxidation of L-[1-13C] phenylalanine by up to 16% (P < 0.05).
","['Five healthy young men (<30 y, BMI\xa0<\xa025)\xa0were each studied at 8 or 10 levels of', 'young healthy adults', 'Healthy Young Men', 'young adults']","['Methionine', 'methionine intakes in random order; 4 levels of L-methionine; 0.5, 1, 2 and 3\xa0mg.kg-1.d-1 (reference diet), 3 intakes of methionine from lentils and 3 intakes from the mixed meal of lentils\xa0+\xa0rice (test diets', 'L-[1-13C] phenylalanine']","['oxidation of L-[1-13C] phenylalanine', 'IAAO response', 'protein synthesis']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0452401', 'cui_str': 'Test diet'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}]",5.0,0.0313797,"Complementation of cooked lentils with rice decreased the oxidation of L-[1-13C] phenylalanine by up to 16% (P < 0.05).
","[{'ForeName': 'Mahroukh', 'Initials': 'M', 'LastName': 'Rafii', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Kaylem', 'Initials': 'K', 'LastName': 'Boileau', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Departments of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tomlinson', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Department\xa0of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxac049']
516,35230463,Another trial for the TARGET trial.,,2022,,[],[],[],[],[],[],,0.303284,,"[{'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Alshaer', 'Affiliation': 'Infectious Disease Pharmacokinetics Laboratory, College of Pharmacy and Emerging Pathogens Institute, University of Florida, 1600 SW Archer Rd, Medical Science Building, PO Box 100486, Gainesville, FL, 32610, USA. mshaer@ufl.edu.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Peloquin', 'Affiliation': 'Infectious Disease Pharmacokinetics Laboratory, College of Pharmacy and Emerging Pathogens Institute, University of Florida, 1600 SW Archer Rd, Medical Science Building, PO Box 100486, Gainesville, FL, 32610, USA.'}]",Intensive care medicine,['10.1007/s00134-022-06654-9']
517,35232217,Screening for Atrial Fibrillation in Older Adults at Primary Care Visits: VITAL-AF Randomized Controlled Trial.,"BACKGROUND


Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single-lead ECG at primary care practice visits increases diagnoses of AF.
METHODS


We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were ages ≥65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses during the 1-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed.
RESULTS


Of 30 715 patients without prevalent AF (n=15 393 screening [91% screened], n=15 322 control), 1.72% of individuals in the screening group had new AF diagnosed at 1 year versus 1.59% in the control group (risk difference, 0.13% [95% CI, -0.16 to 0.42];  P =0.38). In prespecified subgroup analyses, new AF diagnoses in the screening and control groups were greater among those aged ≥85 years (5.56% versus 3.76%, respectively; risk difference, 1.80% [95% CI, 0.18 to 3.30]). The difference in newly diagnosed AF between the screening period and the previous year was marginally greater in the screening versus control group (0.32% versus -0.12%; risk difference, 0.43% [95% CI, -0.01 to 0.84]). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was not different in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (risk difference, 2.7% [95% CI, -5.5 to 10.4]).
CONCLUSIONS


Screening for AF using a single-lead ECG at primary care visits did not affect new AF diagnoses among all individuals aged 65 years or older compared with usual care.
REGISTRATION


URL: https://www.
CLINICALTRIALS


gov; Unique identifier: NCT03515057.",2022,"The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01-0.84).","['Patients included were aged ≥65 years', 'Older Adults at Primary Care Visits', 'individuals aged 65 years or older compared to usual care']","['AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care', 'point-of-care screening with a handheld single lead electrocardiogram (ECG']","['new AF diagnoses', 'Proportions and incidence rates', 'new AF diagnosed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0179504', 'cui_str': 'ECG lead'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0199557', 'cui_str': 'Electrocardiogram, single lead'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",16.0,0.147824,"The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01-0.84).","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lubitz', 'Affiliation': 'Demoulas Center for Cardiac Arrhythmias and Cardiovascular Research Center (S.A.L., S.K., P.T.E.), Massachusetts General Hospital, Boston.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Division of General Internal Medicine (S.J.A., J.M.A., L.H.B., Y.C., D.E.S.), Massachusetts General Hospital, Boston.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine (S.J.A., J.M.A., L.H.B., Y.C., D.E.S.), Massachusetts General Hospital, Boston.'}, {'ForeName': 'Ana T Trisini', 'Initials': 'ATT', 'LastName': 'Lipsanopoulos', 'Affiliation': 'Division of Cardiology (A.T.T.L.), Massachusetts General Hospital, Boston.'}, {'ForeName': 'Leila H', 'Initials': 'LH', 'LastName': 'Borowsky', 'Affiliation': 'Division of General Internal Medicine (S.J.A., J.M.A., L.H.B., Y.C., D.E.S.), Massachusetts General Hospital, Boston.'}, {'ForeName': 'Wyliena', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'University of North Carolina, Chapel Hill (W.G.).'}, {'ForeName': 'Shaan', 'Initials': 'S', 'LastName': 'Khurshid', 'Affiliation': 'Demoulas Center for Cardiac Arrhythmias and Cardiovascular Research Center (S.A.L., S.K., P.T.E.), Massachusetts General Hospital, Boston.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Ellinor', 'Affiliation': 'Demoulas Center for Cardiac Arrhythmias and Cardiovascular Research Center (S.A.L., S.K., P.T.E.), Massachusetts General Hospital, Boston.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine (S.J.A., J.M.A., L.H.B., Y.C., D.E.S.), Massachusetts General Hospital, Boston.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'Division of General Internal Medicine (S.J.A., J.M.A., L.H.B., Y.C., D.E.S.), Massachusetts General Hospital, Boston.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Singer', 'Affiliation': 'Harvard Medical School, Boston, MA (S.A.L., J.M.A., S.K., P.T.E., Y.C., D.E.S.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057014']
518,35240263,Can supplemental protein to low-protein containing meals superimpose on resistance-training muscle adaptations in older adults? A randomized clinical trial.,"PURPOSE


To evaluate the effects of supplementing protein to the low-protein containing meals on selected parameters of muscle mass, strength, and functional capacity in older individuals undergoing resistance training.
METHODS


Thirty-one male and female older individuals (60 to 80 years) were randomized into either a whey protein/WP (n = 15, 20 g at breakfast + 20 g at dinner) or placebo-maltodextrin/PL (n = 16, 20 g at breakfast + 20 g at dinner) group. Both groups underwent a supervised, progressive resistance training (2×/week) program for 12 weeks. Maximal isometric voluntary contraction (MIVC) of knee extensors, muscle thickness (MT) of knee extensors and elbow flexors, rectus femoris muscle quality (MQ), body composition (as measured by DXA) and functional capacity [as measured by 30-s sit-to-stand (30ss) and timed-up-and-go tests (TUG)] were evaluated at baseline and after the 12-week intervention.
RESULTS


Knee extensor MIVC (WP ∆ = 11.9 ± 11.4% and PL ∆ = 12.9 ± 9.9%) was significantly increased over time, with no between-group differences (all p < 0.05 for main effect of time). Upper- and lower-limb MT were significantly increased over time, with no effect of supplementation (WP: ∆ = 7.0 ± 7.3%, PL: ∆ = 9.5 ± 10.3%; and WP: ∆ = 4.5 ± 5.8%, PL: ∆ = 14.7 ± 28.9%, respectively; all p = 0.001 for main effect of time, respectively). Total and upper-limb lean mass were significantly increased, irrespective of the dietary intervention (WP: ∆ = 0.2 ± 6.3%, PL: ∆ = 1.8 ± 2.9%; and WP: ∆ = 0.10 ± 0.03%, PL: ∆ = 0.15 ± 0.02%, respectively; all p < 0.05 for main effect of time). Main effects of time (all p < 0.05) were also found for 30SS and TUG (fast and usual speeds) (WP: ∆ = 18.2 ± 34.4%, PL: ∆ = 10.4 ± 16.9%; WP: ∆ = 5.4 ± 6.7%, PL: ∆ = 0.7 ± 6.0% and WP: ∆ = 3.3 ± 6.1%, PL: ∆ = 2.3 ± 5.2%, respectively).
CONCLUSION


Supplementing additional whey protein to the lowest-protein containing meals (i.e., ~20 g at breakfast and ~20 g at dinner, daily) did not further augment resistance training-induced neuromuscular adaptations (i.e. muscle strength and mass) in healthy older individuals.",2022,Main effects of time (all p < 0.05) were also found for 30SS and TUG (fast and usual speeds) (,"['healthy older individuals', 'older individuals undergoing resistance training', 'older adults', 'Thirty-one male and female older individuals (60 to 80\u202fyears']","['supplementing protein to the low-protein containing meals', 'whey protein/WP (n\u202f=\u202f15, 20\u202fg at breakfast\u202f+\u202f20\u202fg at dinner) or placebo-maltodextrin/PL', 'progressive resistance training (2×/week) program']","['muscle mass, strength, and functional capacity', 'Total and upper-limb lean mass', '30SS and TUG (fast and usual speeds) ', 'Upper- and lower-limb MT', 'Maximal isometric voluntary contraction (MIVC) of knee extensors, muscle thickness (MT) of knee extensors and elbow flexors, rectus femoris muscle quality (MQ), body composition (as measured by DXA) and functional capacity [as measured by 30-s sit-to-stand (30ss) and timed-up-and-go tests (TUG']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",31.0,0.0403139,Main effects of time (all p < 0.05) were also found for 30SS and TUG (fast and usual speeds) (,"[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'de Azevedo Bach', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. Electronic address: simonebach@gmail.com.'}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Radaelli', 'Affiliation': 'Neuromuscular Research Lab, Faculty of Human Kinetics, University of Lisbon, Cruz Quebrada Dafundo, Portugal.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Beck Schemes', 'Affiliation': 'Strength Training Research Group, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Neske', 'Affiliation': 'Strength Training Research Group, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Charlles', 'Initials': 'C', 'LastName': 'Garbelotto', 'Affiliation': 'Nutrition Course, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology and Nutrition Group, School of Physical Education and Sport, Division of Rheumatology, Faculty of Medicine, FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Ronei', 'Initials': 'R', 'LastName': 'Silveira Pinto', 'Affiliation': 'Strength Training Research Group, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Dornelles Schneider', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2022.111760']
519,35240260,"MicroRNA levels in hemodialysis patients following resistance training: Associations with functional performance, inflammatory profile, sestrins-2, and nitric oxide.","OBJECTIVE


Investigate the effects of long-term resistance training (RT) on expression of the four selected microRNAs (miRNA or mir) and further association with biomarkers related to functional performance in older end-stage renal disease (ESRD) patients undergoing hemodialysis.
METHODS


Twenty-five older hemodialysis patients (glomerular filtration rate <15 mL/min/1.73 m 2  aged 68.28 ± 1.06) were recruited for the study. Patients were allocated to two groups (control, n = 12 and RT, n = 13). The RT group completed 24 weeks of training, with sessions held three times per week on alternate days. Blood samples were collected pre- and post- intervention for miRNA and biochemical assays. Results were considered significant at P < 0.05.
RESULTS


RT promoted benefits in inflammatory profile, nitric oxide, sestrins-2, anthropometric data, and functional performance. Trained subjects presented a 51% decrease in miRNA-31 after intervention. In addition, miRNA-1 increased 128% after RT protocol. miRNA-1 significantly correlated with functional performance, inflammatory profile, sestrins-2, and nitric oxide (all P < 0.05).
CONCLUSIONS


These results suggest that the upregulation of miRNA-1 could be associated with physiological benefits promoted by RT in hemodialysis patients, providing novel understanding for potential regulatory miRNA effects on physiological RT response. These findings might point out to strategic direction for future studies.",2022,"RESULTS


RT promoted benefits in inflammatory profile, nitric oxide, sestrins-2, anthropometric data, and functional performance.","['older end-stage renal disease (ESRD) patients undergoing hemodialysis', 'hemodialysis patients following resistance training', 'hemodialysis patients', '15\u202fmL/min/1.73\u202fm 2  aged 68.28\u202f±\u202f1.06) were recruited for the study', 'Twenty-five older hemodialysis patients (glomerular filtration rate']",['long-term resistance training (RT'],"['inflammatory profile, nitric oxide, sestrins-2, anthropometric data, and functional performance', 'functional performance, inflammatory profile, sestrins-2, and nitric oxide']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4708781', 'cui_str': '1.06'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",25.0,0.0127686,"RESULTS


RT promoted benefits in inflammatory profile, nitric oxide, sestrins-2, anthropometric data, and functional performance.","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'de Luca Corrêa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Andrea Lucena', 'Initials': 'AL', 'LastName': 'Reis', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Artur Temizio Oppelt', 'Initials': 'ATO', 'LastName': 'Raab', 'Affiliation': 'Department of Medicine, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Paolo Lucas', 'Initials': 'PL', 'LastName': 'Rodrigues-Silva', 'Affiliation': 'Biotechnology Research Institute, Chinese Academy of Agricultural Sciences, Beijing 100081, China.'}, {'ForeName': 'Jessica Mycaelle Silva', 'Initials': 'JMS', 'LastName': 'Barbosa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Thais Branquinho', 'Initials': 'TB', 'LastName': 'de Araújo', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Marcelo Guido Silveira', 'Initials': 'MGS', 'LastName': 'da Silva', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Carlos Ernesto Santos', 'Initials': 'CES', 'LastName': 'Ferreira', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Octavio Luiz', 'Initials': 'OL', 'LastName': 'Franco', 'Affiliation': 'Centro de Análises Proteômicas e Bioquímicas, Pós-graduação em Ciências Genômicas e Biotecnologia, Universidade Católica de Brasília, Brasília, DF, Brazil; S-Inova Biotech, Pós-graduação em Biotecnologia, Universidade Católica Dom Bosco, Campo Grande, MS, Brazil.'}, {'ForeName': 'Rosângela Vieira', 'Initials': 'RV', 'LastName': 'Andrade', 'Affiliation': 'Graduate Program of Genomic Sciences and Biotechnology, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dos Santos Rosa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil. Electronic address: thiagoacsdkp@yahoo.com.br.'}]",Experimental gerontology,['10.1016/j.exger.2022.111761']
520,35244365,The effectiveness of home-based balance and pulmonary rehabilitation program in individuals with chronic obstructive pulmonary disease: a randomized controlled trial.,"BACKGROUND


Balance impairment and increased fall risk have been demonstrated in individuals with chronic obstructive pulmonary disease (COPD). However, studies investigating the effects of balance training especially when combined with pulmonary rehabilitation (PR) program in home-based setting are scarce.
AIM


To examine whether adding balance training to home-based pulmonary rehabilitation improves balance, fall risk, and disease-related symptoms in individuals with COPD.
DESIGN


Randomized, controlled, assessor-blinded trial with parallel two-group design.
SETTING


Home-based setting.
POPULATION


Forty-eight individuals diagnosed with COPD.
METHODS


Participants with COPD were randomly allocated to either a home-based PR or home-based balance training combined with PR (PR-BT) group (24 per group). Both groups exercised three days per week for eight-week. Primary outcomes were fall risk index and functional balance as measured by the Physiological Profile Assessment (PPA) and Timed Up and Go (TUG), respectively. Secondary outcomes were the Activities-specific Balance Confidence (ABC), Modified Medical Research Council dyspnea (mMRC), Six-Minute Walk Test (6MWT), and COPD assessment test (CAT). All outcome measures were assessed at baseline, post-intervention, and three-month follow-up.
RESULTS


All participants completed the trial, with no reported adverse events. At post-intervention, the PR-BT group demonstrated significantly greater improvements in PPA fall risk score (PR-BT: 1.1±0.8, PR: 2.4±1.5), TUG (PR-BT: 10.7±1.3, PR: 14.4±4.4 s) and these improvements remained at three-month follow-up (all P<0.01). The ABC, mMRC, and CAT scores were also significant better for the PR-BT than the PR group both after intervention and at three-month follow-up (all P<0.05).
CONCLUSIONS


Eight-week home-based balance and PR program is effective in improving balance as well as dyspnea, and well-being in individuals with COPD.
CLINICAL REHABILITATION IMPACT


Home-based balance and PR program is a promising approach for COPD rehabilitation especially in patients who are at risk of falls.",2022,"The ABC, mMRC, and CAT scores were also significant better for the PR-BT than the PR group both after intervention and at three-month follow-up (all p <0.05).
","['Participants with COPD', 'Home-based setting', 'individuals with chronic obstructive pulmonary disease', 'Forty-eight individuals diagnosed with COPD', 'individuals with COPD', 'individuals with chronic obstructive pulmonary disease (COPD', 'patients who are at risk of falls']","['PR program', 'balance training to home-based pulmonary rehabilitation', 'home-based balance and pulmonary rehabilitation program', 'home-based PR or home-based balance training combined with PR (PR-BT', 'pulmonary rehabilitation (PR) program']","['Activities-specific Balance Confidence (ABC), Modified Medical Research Council dyspnea (mMRC), Six-Minute Walk Test (6MWT), and COPD assessment test (CAT', 'balance, fall risk, and disease-related symptoms', 'fall risk index and functional balance as measured by the Physiological Profile Assessment (PPA) and Timed Up and Go (TUG', 'ABC, mMRC, and CAT scores', 'adverse events', 'PPA fall risk score']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1319362', 'cui_str': 'Falls assessment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",48.0,0.0531757,"The ABC, mMRC, and CAT scores were also significant better for the PR-BT than the PR group both after intervention and at three-month follow-up (all p <0.05).
","[{'ForeName': 'Busaba', 'Initials': 'B', 'LastName': 'Chuatrakoon', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sureeporn', 'Initials': 'S', 'LastName': 'Uthaikhup', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Shirley P', 'Initials': 'SP', 'LastName': 'Ngai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Chalerm', 'Initials': 'C', 'LastName': 'Liwsrisakun', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Chaicharn', 'Initials': 'C', 'LastName': 'Pothirat', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand - somporn.sungkarat@cmu.ac.th.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.22.07383-X']
521,35247794,The Disease Recovery Evaluation and Modification (DREaM) study: Effectiveness of paliperidone palmitate versus oral antipsychotics in patients with recent-onset schizophrenia or schizophreniform disorder.,"We report primary results of the Disease Recovery Evaluation and Modification (DREaM) study, a randomized, open-label, delayed-start trial designed to compare the effectiveness of paliperidone palmitate (PP) versus oral antipsychotics (OAP) in delaying time to first treatment failure (TtFTF) in participants with recent-onset schizophrenia or schizophreniform disorder. DREaM included: Part I, 2-month oral run-in; Part II, 9-month disease progression phase (PP or OAP); Part III, 9 months of additional treatment (PP/PP; OAP rerandomized: OAP/OAP or OAP/PP). PP/PP and OAP/OAP comprised the 18-month extended disease progression (EDP) analysis. A total of 235 participants were randomized to PP (n = 78) or OAP (n = 157) in Part II. No statistically significant differences in TF between treatment groups were identified during Part II (PP 29.5%, OAP 24.8%; P = 0.377), Part III (PP/PP 14.3%, OAP/PP 15.8%, OAP/OAP 28.6%; P = 0.067) or the EDP analysis (PP/PP 28.6%, OAP/OAP 44.4%; NNT = 6; P = 0.080). Using a modified definition of TF excluding treatment supplementation with another antipsychotic, a common approach to managing dose adjustments, significant differences were observed between treatment groups in Part III (PP/PP 4.1%, OAP/PP 14.0%, OAP/OAP 27.0%; P = 0.002) and EDP (PP/PP 14.3%, OAP/OAP 42.9%; P = 0.001). Safety results were consistent with the known safety profile of PP. Although significant treatment differences were not observed during the first 9 months of DREaM, numerical differences favoring PP emerged in the last 9 months and significant differences were observed when TF criteria were limited to their most impactful components. These results highlight the potential benefit of initiating PP early in the course of schizophrenia and provide valuable insights for future clinical trials in recent-onset schizophrenia or schizophreniform disorder. Clinicaltrials.gov identifier: NCT02431702.",2022,"No statistically significant differences in TF between treatment groups were identified during Part II (PP 29.5%, OAP 24.8%; P = 0.377), Part III (PP/PP 14.3%, OAP/PP 15.8%, OAP/OAP 28.6%; P = 0.067) or the EDP analysis (PP/PP 28.6%, OAP/OAP 44.4%; NNT = 6; P = 0.080).","['participants with recent-onset schizophrenia or schizophreniform disorder', '235 participants', 'patients with recent-onset schizophrenia or schizophreniform disorder']","['paliperidone palmitate (PP) versus oral antipsychotics (OAP', 'OAP', 'oral antipsychotics', 'paliperidone palmitate']","['TF', 'EDP']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036358', 'cui_str': 'Schizophreniform disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2719626', 'cui_str': 'Paliperidone palmitate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",235.0,0.129033,"No statistically significant differences in TF between treatment groups were identified during Part II (PP 29.5%, OAP 24.8%; P = 0.377), Part III (PP/PP 14.3%, OAP/PP 15.8%, OAP/OAP 28.6%; P = 0.067) or the EDP analysis (PP/PP 28.6%, OAP/OAP 44.4%; NNT = 6; P = 0.080).","[{'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Alphs', 'Affiliation': 'Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA.'}, {'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': 'Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. Electronic address: bbrown59@its.jnj.com.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Turkoz', 'Affiliation': 'Janssen Research and Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. Electronic address: ITurkoz@its.jnj.com.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Baker', 'Affiliation': 'Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. Electronic address: pbaker16@its.jnj.com.'}, {'ForeName': 'Dong-Jing', 'Initials': 'DJ', 'LastName': 'Fu', 'Affiliation': 'Janssen Research and Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. Electronic address: dfu@its.jnj.com.'}, {'ForeName': 'Keith H', 'Initials': 'KH', 'LastName': 'Nuechterlein', 'Affiliation': 'Departments of Psychiatry and Psychology, University of California at Los Angeles, 150 Medical Plaza Driveway, Los Angeles, CA 90095, USA. Electronic address: keithn@ucla.edu.'}]",Schizophrenia research,['10.1016/j.schres.2022.02.019']
522,35248737,Management of patients with rheumatoid arthritis by telemedicine: connected monitoring. A randomized controlled trial.,"OBJECTIVES


Rheumatoid arthritis (RA) is a prevalent and disabling disease that is the source of significant direct and indirect costs. The current recommended therapeutic strategy is based on the rapid introduction of therapy with conventional Disease-Modifying Anti-Rheumatic Drugs (DMARDs) combined with regular disease monitoring by the rheumatologist. The onerous nature of such intense monitoring has motivated the development of new, less demanding strategies such as telemedicine. This study aimed to estimate the cost-effectiveness of the connected monitoring of RA patients initiating a new DMARD therapy versus conventional monitoring.
METHODS


An economic evaluation based on a randomized controlled trial of 89 patients was conducted. The patients in the intervention group (n=45) were monitored using a connected monitoring interface on a smartphone, while patients in the control group (n=44) were conventionally monitored. Health outcomes were measured as the gain in quality-adjusted life-years (QALYs), assessed using the EuroQol-5D questionnaire. Resource use and health outcomes were collected alongside the trial and at the six-month follow-up using application data and the related clinical case manager time, visits, hospitalisations, and transport records. These outcomes were valued using externally collected data on unit costs and QALY weights.
RESULTS


Compared to conventionally monitored patients, patients receiving connected monitoring had a slightly greater but not significant gain in the average QALY of 0.07. The economic analysis found that connected monitoring resulted in a significant cost reduction of 72€ (2927€ vs. 2999€, P<0.01). The incremental cost-utility ratio of the intervention was equal to -1,029€ per QALY (95% CI: -32,033; +24,625) with a 97.8% chance of being cost-effective at a threshold of 30,000€ per QALY gained.
CONCLUSION


Implementing EULAR recommendations for RA patients initiating a DMARD treatment using connected monitoring is more efficient and less expensive than conventional care.
CLINICAL TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT03005925).",2022,"Compared to conventionally monitored patients, patients receiving connected monitoring had a slightly greater but not significant gain in the average QALY of 0.07.","['89 patients was conducted', 'patients with rheumatoid arthritis by']","['telemedicine', 'DMARD therapy versus conventional monitoring']","['incremental cost-utility ratio', 'gain in quality-adjusted life-years (QALYs), assessed using the EuroQol-5D questionnaire', 'unit costs and QALY weights', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",89.0,0.0837106,"Compared to conventionally monitored patients, patients receiving connected monitoring had a slightly greater but not significant gain in the average QALY of 0.07.","[{'ForeName': 'Laurene', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'IRMB, University of Montpellier, Inserm U1183, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Verushka', 'Initials': 'V', 'LastName': 'Valsecchi', 'Affiliation': 'IRMB, University of Montpellier, Inserm U1183, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Mura', 'Affiliation': 'Clinical Research and Epidemiology Unit (URCE), CHU Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Aouinti', 'Affiliation': 'Clinical Research and Epidemiology Unit (URCE), CHU Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Padern', 'Affiliation': 'IRMB, University of Montpellier, Inserm U1183, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Ferreira', 'Affiliation': 'IRMB, University of Montpellier, Inserm U1183, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Jenica', 'Initials': 'J', 'LastName': 'Pastor', 'Affiliation': 'Clinical Research and Medico economic Unit (URME), CHU Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jorgensen', 'Affiliation': 'IRMB, University of Montpellier, Inserm U1183, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Mercier', 'Affiliation': 'Clinical Research and Medico economic Unit (URME), CHU Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Yves-Marie', 'Initials': 'YM', 'LastName': 'Pers', 'Affiliation': 'IRMB, University of Montpellier, Inserm U1183, CHU Montpellier, Montpellier, France. Electronic address: ympers2000@yahoo.fr.'}]",Joint bone spine,['10.1016/j.jbspin.2022.105368']
523,35006266,Safety and Effectiveness of Long-term Intravenous Administration of Edaravone for Treatment of Patients With Amyotrophic Lateral Sclerosis.,"Importance


Intravenous edaravone is approved as a disease-modifying drug for patients with amyotrophic lateral sclerosis (ALS), but evidence for efficacy is limited to short-term beneficial effects shown in the MCI186-ALS19 study in a subpopulation in which efficacy was expected.
Objective


To evaluate the long-term safety and effectiveness of intravenous edaravone therapy for patients with ALS in a real-world clinical setting.
Design, Setting, and Participants


Multicenter, propensity score-matched cohort study conducted between June 2017 and March 2020 at 12 academic ALS referral centers associated with the German Motor Neuron Disease Network. Of 1440 patients screened, 738 were included in propensity score matching. Final analyses included 324 patients with ALS comprising 194 patients who started intravenous edaravone treatment (141 received ≥4 consecutive treatment cycles; 130 matched) and 130 propensity score-matched patients with ALS receiving standard therapy. All patients had probable or definite ALS according to the El Escorial criteria, with disease onset between December 2012 and April 2019. Subgroups were defined by applying the MCI186-ALS19 study inclusion criteria to evaluate whether patients would have been considered eligible (EFAS) or ineligible (non-EFAS).
Exposures


Intravenous edaravone plus riluzole vs riluzole only.
Main Outcomes and Measures


Patient characteristics and systematic safety assessment for patients who received at least 1 dose of intravenous edaravone. Effectiveness assessment of edaravone was conducted among patients who received at least 4 treatment cycles compared with propensity score-matched patients with ALS who received only standard therapy. Primary outcome was disease progression measured by decrease in the ALS Functional Rating Scale-Revised (ALSFRS-R) score. Secondary outcomes were survival probability, time to ventilation, and change in disease progression before vs during treatment. To account for the matched design, patients receiving edaravone and their corresponding matched controls were regarded as related samples in disease progression analyses; stratification for propensity score quintiles was used for survival probability and time to ventilation analyses.
Results


A total of 194 patients started intravenous edaravone treatment; 125 (64%) were male, and the median age was 57.5 years (IQR, 50.7-63.8 years). Potential adverse effects were observed in 30 cases (16%), most notably infections at infusion sites and allergic reactions. Disease progression among 116 patients treated for a median of 13.9 months (IQR, 8.9-13.9 months) with edaravone did not differ from 116 patients treated for a median of 11.2 months (IQR, 6.4-20.0 months) with standard therapy (ALSFRS-R points/month, -0.91 [95% CI, -0.69 to -1.07] vs -0.85 [95% CI, -0.66 to -0.99]; P = .37). No significant differences were observed in the secondary end points of survival probability, time to ventilation, and change in disease progression. Similarly, outcomes between patients treated with edaravone and matched patients did not differ within the EFAS and non-EFAS subgroups.
Conclusions and Relevance


This cohort study using propensity score matching found that, although long-term intravenous edaravone therapy for patients with ALS was feasible and mainly well tolerated, it was not associated with any disease-modifying benefit. Intravenous edaravone may not provide a clinically relevant additional benefit compared with standard therapy alone.",2022,"No significant differences were observed in the secondary end points of survival probability, time to ventilation, and change in disease progression.","['194 patients started intravenous edaravone treatment; 125 (64%) were male, and the median age was 57.5 years (IQR, 50.7-63.8 years', 'patients with ALS', '324 patients with ALS comprising 194 patients who started intravenous edaravone treatment (141 received ≥4 consecutive treatment cycles; 130 matched) and 130 propensity score-matched patients with ALS receiving standard therapy', 'Patients With Amyotrophic Lateral Sclerosis', 'patients who received at least 4 treatment cycles compared with propensity score-matched patients with ALS who received only standard therapy', 'patients with amyotrophic lateral sclerosis (ALS', 'Participants\n\n\nMulticenter, propensity score-matched cohort study conducted between June 2017 and March 2020 at 12 academic ALS referral centers associated with the German Motor Neuron Disease Network', 'All patients had probable or definite ALS according to the El Escorial criteria, with disease onset between December 2012 and April 2019', 'patients would have been considered eligible (EFAS) or ineligible (non-EFAS', 'patients with ALS in a real-world clinical setting', '1440 patients screened, 738 were included in propensity score matching']","['edaravone plus riluzole vs riluzole', 'intravenous edaravone therapy', 'edaravone', 'Intravenous edaravone', 'Edaravone']","['Safety and Effectiveness', 'disease progression', 'survival probability, time to ventilation, and change in disease progression', 'Potential adverse effects', 'Disease progression', 'ALS Functional Rating Scale-Revised (ALSFRS-R) score', 'survival probability and time to ventilation analyses', 'Main Outcomes and Measures\n\n\nPatient characteristics and systematic safety assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0085084', 'cui_str': 'Motor neuron disease'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4517576', 'cui_str': '1440'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",194.0,0.0499462,"No significant differences were observed in the secondary end points of survival probability, time to ventilation, and change in disease progression.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Witzel', 'Affiliation': 'Department of Neurology, Ulm University, Ulm, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Maier', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Centre for ALS and other Motor Neuron Diseases, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Steinbach', 'Affiliation': 'Thuringian Neuromuscular Center, Department of Neurology, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Grosskreutz', 'Affiliation': 'Precision Neurology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Koch', 'Affiliation': 'Department of Neurology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Sarikidi', 'Affiliation': 'Department of Neurology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Petri', 'Affiliation': 'Department of Neurology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Günther', 'Affiliation': 'Department of Neurology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Department of Neurology, Diakonissenkrankenhaus, Mannheim, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hermann', 'Affiliation': 'Translational Neurodegeneration Section ""Albrecht Kossel,"" Department of Neurology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Prudlo', 'Affiliation': 'DZNE, Site Rostock/Greifswald, Rostock, Germany.'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Cordts', 'Affiliation': 'Department of Neurology, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lingor', 'Affiliation': 'Department of Neurology, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Wolfgang N', 'Initials': 'WN', 'LastName': 'Löscher', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Zacharias', 'Initials': 'Z', 'LastName': 'Kohl', 'Affiliation': 'Department of Neurology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hagenacker', 'Affiliation': 'Department of Neurology, University Medicine Essen, Essen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ruckes', 'Affiliation': 'University Medical Center of the Johannes Gutenberg-University, Interdisciplinary Center for Clinical Trials (IZKS), Mainz, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Koch', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Centre for ALS and other Motor Neuron Diseases, Berlin, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Spittel', 'Affiliation': 'Ambulanzpartner Soziotechnologie APST GmbH, Berlin, Germany.'}, {'ForeName': 'Kornelia', 'Initials': 'K', 'LastName': 'Günther', 'Affiliation': 'Department of Neurology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Michels', 'Affiliation': 'Department of Neurology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Dorst', 'Affiliation': 'Department of Neurology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Centre for ALS and other Motor Neuron Diseases, Berlin, Germany.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'Ludolph', 'Affiliation': 'Department of Neurology, Ulm University, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2021.4893']
524,35260261,"Psychometric assessment of the consideRATE questions, a new measure of serious illness experience, with an online simulation study.","OBJECTIVE


To assess the psychometric properties of the consideRATE questions, a measure of serious illness experience.
METHODS


We recruited people at least 50 years old via paid panels online, with US-Census-based quotas. We randomized participants to a patient experience story at two time points. Participants completed a series of measures, including the consideRATE questions. We assessed convergent (Pearson's correlation), discriminative (one-way ANOVA with Tukey's test for multiple comparisons) and divergent (Pearson's correlation) validity. We also assessed intra-rater reliability (intra-class correlation) and responsiveness to change (t-tests).
RESULTS


We included 809 individuals in our analysis. We established convergent validity (r = 0.77; p < 0.001); discriminative validity (bad/neutral stories [mean diff=0.4; p < 0.001]; neutral/ good stories [mean diff=1.3; p < 0.001]) and moderate divergent validity (r = 0.57; p < 0.001). We established sensitivity to change in all stories (bad/good [mean diff=1.52; p < 0.001]; good/bad [mean diff= -1.68; p < 0.001]; neutral/bad [mean diff= -0.57; p < 0.001]; good/neutral [mean diff= -1.11; p < 0.001]; neutral/good [mean diff= 1.1; p < 0.001]) but one (bad/neutral [mean diff= 0.4; p < 0.07]). Intra-rater reliability was demonstrated between time points (r = 0.77; p < 0.001).
CONCLUSIONS


the consideRATE questions were reliable and valid in a simulated online test.
PRACTICE IMPLICATIONS


the consideRATE questions may be a practical way to measure serious illness experience and the effectiveness of interventions to improve it.",2022,We established sensitivity to change in all stories (bad/good [mean diff=1.52; p < 0.001]; good/bad [mean diff= -1.68; p < 0.001]; neutral/bad [mean diff= -0.57; p < 0.001]; good/neutral [mean diff= -1.11; p < 0.001]; neutral/good [mean diff= 1.1; p < 0.001]) but,"['recruited people at least 50 years old via paid panels online, with US-Census-based quotas', '809 individuals in our analysis']",[],"['moderate divergent validity', 'discriminative validity', 'Intra-rater reliability', 'intra-rater reliability (intra-class correlation) and responsiveness to change (t-tests']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",809.0,0.0581667,We established sensitivity to change in all stories (bad/good [mean diff=1.52; p < 0.001]; good/bad [mean diff= -1.68; p < 0.001]; neutral/bad [mean diff= -0.57; p < 0.001]; good/neutral [mean diff= -1.11; p < 0.001]; neutral/good [mean diff= 1.1; p < 0.001]) but,"[{'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Saunders', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, One Medical Center Drive, Lebanon, USA; Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, USA. Electronic address: catherinehylassaunders@gmail.com.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Durand', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, One Medical Center Drive, Lebanon, USA. Electronic address: Marie-Anne.Durand@dartmouth.edu.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Kirkland', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, One Medical Center Drive, Lebanon, USA; Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, USA. Electronic address: Kathryn.B.Kirkland@hitchcock.org.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'MacMartin', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, USA. Electronic address: Meredith.A.MacMartin@hitchcock.org.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Barnato', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, One Medical Center Drive, Lebanon, USA; Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, USA. Electronic address: Amber.Barnato@dartmouth.edu.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Elwyn', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, One Medical Center Drive, Lebanon, USA. Electronic address: glynelwyn@gmail.com.'}]",Patient education and counseling,['10.1016/j.pec.2022.01.002']
525,35262315,Observing treatment outcomes in other patients can elicit augmented placebo effects on pain treatment: a double-blinded randomized clinical trial with patients with chronic low back pain.,"ABSTRACT


Clinical research on social observational learning (SoL) as an underlying mechanism for inducing expectancy and eliciting analgesic placebo effects is lacking. This double-blinded randomized controlled clinical trial investigated the influence of SoL on medication-augmenting placebo effects in 44 patients with chronic low back pain. Our hypothesis was that observing positive drug effects on pain and mobility in another patient could increase pain reduction and functional capacity. To test this, we compared the effects of observing positive treatment outcomes in a sham patient (the social learning group [SoLG]) vs hearing the same sham patient report neutral effects (the control group). In the SoLG, the sham patient told peers about pain reduction due to amitriptyline and demonstrated his improved mobility by bending forwards and sideways while he told the control group only that he was taking amitriptyline. The primary outcome was a reduction in clinical low back pain self-ratings. The secondary outcome was perceptions of pain-related disability. The exploratory outcome was mood and coping statements. Data collection occurred before and after the intervention and 2 weeks later. After the intervention, pain decreased in both groups (F [1, 41] = 7.16, P < 0.05, d = 0.83), with no difference between groups. However, the SoLG showed a significantly larger decrease in perceived disability (F [1, 41] = 5, P < 0.05, d = 0.63). The direct observation of patient with chronic low back pain of positive treatment outcomes in the sham patient seems to have enhanced the treatment effects while indirect verbal reports of reduced pain did not.",2022,"After the intervention, pain decreased in both groups (F [1, 41] = 7.16, P < 0.05, d = 0.83), with no difference between groups.","['44 patients with chronic low back pain', 'patients with chronic low back pain']","['social observational learning (SoL', 'placebo', 'amitriptyline', 'social learning group [SoLG', 'SoL on medication-augmenting placebo']","['pain', 'pain treatment', 'perceived disability', 'clinical low back pain self-ratings', 'perceptions of pain-related disability', 'pain reduction and functional capacity', 'pain and mobility', 'mobility', 'pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002600', 'cui_str': 'Amitriptyline'}, {'cui': 'C0679082', 'cui_str': 'Social Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",44.0,0.529605,"After the intervention, pain decreased in both groups (F [1, 41] = 7.16, P < 0.05, d = 0.83), with no difference between groups.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Laura-Marie', 'Initials': 'LM', 'LastName': 'Fischer', 'Affiliation': 'Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bläute', 'Affiliation': 'Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stork', 'Affiliation': 'Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'University of Maryland School of Nursing & School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zöllner', 'Affiliation': 'Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Klinger', 'Affiliation': 'Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Eppendorf, Hamburg, Germany.'}]",Pain,['10.1097/j.pain.0000000000002513']
526,34861776,Ultra-Mini-Percutaneous Nephrolithotomy in Flank-Free Modified Supine Position  vs  Prone Position in Treatment of Pediatric Renal Pelvic and Lower Caliceal Stones.,"Objectives:  To report the safety and efficacy of ultra-mini-percutaneous nephrolithotomy (UMPCNL) in flank-free modified supine (FFMS) and prone positions in management of pediatric renal calculi.  Patients and Methods:  This prospective randomized study included 55 pediatric patients with symptomatic renal stones and suitable for UMPCNL. They were randomized into two groups. Group A included 28 patients who were treated by UMPCNL in FFMS position (with a pad below the ipsilateral shoulder and buttocks, putting ipsilateral upper limb over the chest, and crossing the extended ipsilateral lower limb over the flexed contralateral one) and Group B included 27 patients treated by UMPCNL in the prone position. In both groups dilatation was done to 13F sheath allowing the introduction of 6/7.5F semirigid ureteroscope and fragmentation of stones by Holmium: yttrium-aluminum-garnet laser with a 550-μm fiber laser lithotripter.  Results:  The operation time in FFMS position UMPCNL group was significantly shorter than prone position UMPCNL group (84.3 ± 9.87  vs  99.3 ± 8.75 minutes) with  p  = 0.022. There was no significant difference between both groups in terms of stone-free rate (89.3%  vs  88.9%), overall complication rate (including transient fever; 21.4%  vs  18.5%), postoperative pain (visual analog scale score; 3.4 ± 0.8  vs  3.3 ± 0.9), or hospital stay (3.53 ± 0.8  vs  4.1 ± 1.1 days).  Conclusion:  Both UMPCNL in FFMs and prone positions are feasible, safe, and effective in treatment of pediatric renal stones with relatively shorter operative time in FFMS position.",2022,"Both UMPCNL in FFMs and prone positions are feasible, safe, and effective in treatment of pediatric renal stones with relatively shorter operative time in FFMS position.","['28 patients who were treated by UMPCNL in FFMS position (with a pad below the ipsilateral shoulder and buttocks, putting ipsilateral upper limb over the chest, and crossing the extended ipsilateral lower limb over the flexed contralateral one) and Group B included 27 patients treated by UMPCNL in the prone position', '55 pediatric patients with symptomatic renal stones and suitable for UMPCNL']","['Holmium: yttrium-aluminum-garnet laser with a 550-μm fiber laser lithotripter', 'ultra-mini-percutaneous nephrolithotomy (UMPCNL', 'Ultra-Mini-Percutaneous Nephrolithotomy in Flank-Free Modified Supine Position  vs  Prone Position']","['stone-free rate', 'overall complication rate', 'hospital stay', 'postoperative pain (visual analog scale score', 'operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0006497', 'cui_str': 'Buttock structure'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0181676', 'cui_str': 'Laser lithotripter'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",55.0,0.0136582,"Both UMPCNL in FFMs and prone positions are feasible, safe, and effective in treatment of pediatric renal stones with relatively shorter operative time in FFMS position.","[{'ForeName': 'Esam A E', 'Initials': 'EAE', 'LastName': 'Desoky', 'Affiliation': 'Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Sakr', 'Affiliation': 'Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ehab R', 'Initials': 'ER', 'LastName': 'ElSayed', 'Affiliation': 'Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Ali', 'Affiliation': 'Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Journal of endourology,['10.1089/end.2021.0557']
527,35263457,Prospective randomized controlled study of a microfluidic chip technology for sperm selection in male infertility patients.,"The purpose of this study is to evaluate the impact of a microfluidic approach for spermatozoon selection in male infertility patients undergoing intracytoplasmic sperm injection (ICSI). This research enrolled 128 individuals who had ICSI for male-factor infertility. The patients were separated into two groups according to the method used to pick the spermatozoa: group I (n = 64), which used traditional swim-up procedures, and group II (n = 64), which used the Fertile Chip for spermatozoon selection during ICSI therapy. Fertilization rates and embryo quality were the major outcomes. The rates of pregnancy, clinical pregnancy and live birth were used as secondary outcomes. As a result, there was no statistically significant difference between the two groups in terms of fertilization rate, total grade 1 and 2 embryos. Implantation rate was significantly higher in the Fertile Chip group than in the control group (50% vs. 31%, p = 0.02). The Fertile Chip group had considerably greater pregnancy rates, clinical pregnancy rates (CPR) and live birth rates than the control group (62.5% vs. 45.3%, p = 0.038; 59.4% vs. 35.9%, p = 0.006 and 46.8% vs. 25%, p = 0.009). Fertile Chip had no effect on fertilization rates or embryo quality in male-factor infertility couples. However, the Fertile Chip group had a statistically higher pregnancy rate, CPR and live birth rate.",2022,"The Fertile Chip group had considerably greater pregnancy rates, clinical pregnancy rates (CPR) and live birth rates than the control group (62.5% vs. 45.3%, p = 0.038; 59.4% vs. 35.9%, p = ","['128 individuals who had ICSI for male-factor infertility', 'male infertility patients', 'male infertility patients undergoing intracytoplasmic sperm injection (ICSI', 'male-factor infertility couples']","['microfluidic approach', 'microfluidic chip technology']","['Implantation rate', 'rates of pregnancy, clinical pregnancy and live birth', 'fertilization rates or embryo quality', 'pregnancy rate, CPR and live birth rate', 'fertilization rate, total grade 1 and 2 embryos', 'pregnancy rates, clinical pregnancy rates (CPR) and live birth rates', 'Fertilization rates and embryo quality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C1257867', 'cui_str': 'Microfluidics'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]",128.0,0.0547638,"The Fertile Chip group had considerably greater pregnancy rates, clinical pregnancy rates (CPR) and live birth rates than the control group (62.5% vs. 45.3%, p = 0.038; 59.4% vs. 35.9%, p = ","[{'ForeName': 'Şirin', 'Initials': 'Ş', 'LastName': 'Aydın', 'Affiliation': 'Baskent University Adana Dr. Turgut Noyan Application and Research Center, Adana, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Bulgan Kılıçdağ', 'Affiliation': 'Baskent University Adana Dr. Turgut Noyan Application and Research Center, Adana, Turkey.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Çağlar Aytaç', 'Affiliation': 'Baskent University Adana Dr. Turgut Noyan Application and Research Center, Adana, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Çok', 'Affiliation': 'Baskent University Adana Dr. Turgut Noyan Application and Research Center, Adana, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Şimşek', 'Affiliation': 'Baskent University Adana Dr. Turgut Noyan Application and Research Center, Adana, Turkey.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Haydardedeoğlu', 'Affiliation': 'Baskent University Adana Dr. Turgut Noyan Application and Research Center, Adana, Turkey.'}]",Andrologia,['10.1111/and.14415']
528,35266297,Evaluation of the potential for pharmacokinetic interaction between tirabrutinib and levonorgestrel/ethinyl estradiol in healthy female volunteers.,"Tirabrutinib (TIRA), a potent and nonreversible oral Bruton tyrosine kinase inhibitor, is evaluated for treatment of certain hematological malignancies and inflammatory diseases. A drug-drug interaction study to evaluate the effect of TIRA on the pharmacokinetics of the oral contraceptive levonorgestrel (LEVO)/ethinyl estradiol (EE) was conducted in healthy female participants (N = 26). Participants received a single dose of LEVO (150 mcg)/EE (30 mcg) alone (reference), and on day 12 of a 15-day regimen of TIRA 160 mg once-daily (test). Intensive blood sampling for determination of LEVO, EE, and TIRA plasma concentrations was conducted, and safety was assessed throughout the study. Pharmacokinetic interactions were evaluated using 90% confidence intervals (CIs) of the geometric least squares mean (GLSM) ratios of the test versus reference treatments. The GLSM (90% CI) ratios of area under the concentration-time curve from zero to infinity (AUC inf  ; LEVO: 0.95, 95% CI: 0.88-1.03, EE: 1.10, 95% CI: 1.05-1.16) and maximum plasma concentration (C max  ; LEVO: 0.85, 95% CI: 0.74-0.98, EE: 1.07, 95% CI: 0.98-1.18) were within the prespecified 0.70 to 1.43 no effect bounds; and the AUC ratios met the stricter 0.80 to 1.25 equivalence bounds. Study treatments were generally well-tolerated. In conclusion, co-administration with TIRA did not alter the exposure of LEVO/EE, and accordingly LEVO/EE containing oral contraceptives can serve as a contraception method for participants on TIRA 160 mg (or lower) daily doses.",2022,The GLSM (90% CI) ratios of AUC inf  [LEVO: 0.95 (0.88-1.03); EE: 1.10 (1.05-1.16)] and C max  [LEVO: 0.85 (0.74-0.98); EE: 1.07 (0.98-1.18)] were within the prespecified 0.70 to 1.43 no effect bounds; and the AUC ratios met the stricter 0.80 to 1.25 equivalence bounds.,"['Healthy Female Volunteers', 'healthy female participants (N=26']","['LEVO', 'TIRA', 'oral contraceptive levonorgestrel (LEVO)/ethinyl estradiol (EE', 'Tirabrutinib and Levonorgestrel/Ethinyl Estradiol']","['Pharmacokinetic interactions', 'LEVO, EE and TIRA plasma concentrations', 'tolerated']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}]","[{'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0843786,The GLSM (90% CI) ratios of AUC inf  [LEVO: 0.95 (0.88-1.03); EE: 1.10 (1.05-1.16)] and C max  [LEVO: 0.85 (0.74-0.98); EE: 1.07 (0.98-1.18)] were within the prespecified 0.70 to 1.43 no effect bounds; and the AUC ratios met the stricter 0.80 to 1.25 equivalence bounds.,"[{'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Cherala', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Anubhav', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tarnowski', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}]",Clinical and translational science,['10.1111/cts.13265']
529,35266296,Cardiorenal outcomes with ertugliflozin assessed according to baseline glucose-lowering agent: An analysis from VERTIS CV.,"AIM


To assess selected cardiorenal outcomes with ertugliflozin according to use of baseline glucose-lowering agent.
MATERIALS AND METHODS


VERTIS CV was a cardiovascular (CV) outcome trial for ertugliflozin versus placebo, conducted in patients with type 2 diabetes and established atherosclerotic CV disease. The primary outcome was time to the first event of CV death, myocardial infarction or stroke (major adverse CV events [MACE]), with other CV outcomes also assessed. Outcomes were analysed using Cox proportional hazards models stratified by baseline use of metformin, insulin, sulphonylureas (SUs) and dipeptidyl peptidase-4 (DPP-4) inhibitors, with interaction testing to assess for treatment effect modification. Changes from baseline in glycaemic, metabolic and haemodynamic variables were also assessed.
RESULTS


Of 8246 randomized patients, at baseline 6286 (76%) were on metformin, 3898 (47%) were on insulin, 3383 (41%) were on SUs and 911 (11%) were on DPP-4 inhibitors, alone or in combination therapy (67% used >1 glucose-lowering agent at baseline). For each glucose-lowering agent evaluated, no evidence for effect modification was observed for MACE by baseline use of metformin (with: hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.790, 1.073; without: 1.13, 95% CI 0.867, 1.480), insulin (with: HR 0.91, 95% CI 0.765, 1.092; without: 1.06, 95% CI 0.867, 1.293), SUs (with: HR 1.11, 95% CI 0.890, 1.388; without: 0.90, 95% CI 0.761, 1.060) or DPP-4 inhibitors (with: HR 0.77, 95% CI 0.502, 1.173; without: 1.00, 95% CI 0.867, 1.147) (all P interaction   > 0.05). Similar results were observed for all secondary outcomes analysed.
CONCLUSION


In VERTIS CV, the effects of ertugliflozin on cardiorenal outcomes were consistent across subgroups of patients stratified by baseline glucose-lowering agent.
CLINICALTRIALS


gov identifier: NCT01986881.",2022,"In VERTIS CV, the effects of ertugliflozin on cardiorenal outcomes were consistent across subgroups of patients stratified by baseline glucose-lowering agent.","['Of 8246 randomized patients, at baseline 6286 (76%) were on metformin, 3898 (47%) insulin, 3383 (41%) sulfonylureas (SU) and 911 (11', 'patients with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD']","['metformin', 'ertugliflozin', 'ertugliflozin vs placebo', 'DPP-4 inhibitors, alone or in combination therapy', 'ertugliflozin by baseline glucose-lowering agent', 'baseline glucose-lowering agent']","['glycaemic, metabolic and hemodynamic parameters', 'time to the first event of CV death, myocardial infarction, or stroke (major adverse CV events, MACE', 'cardiorenal outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",8246.0,0.33423,"In VERTIS CV, the effects of ertugliflozin on cardiorenal outcomes were consistent across subgroups of patients stratified by baseline glucose-lowering agent.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14691']
530,35219521,Intraoperative High Tidal Volume Ventilation and Postoperative Acute Respiratory Distress Syndrome in Liver Transplant.,"BACKGROUND


Mechanical ventilation plays an important role in perioperative management and patient outcomes. Although mechanical ventilation with high tidal volume (HTV) is injurious in patients in the intensive care unit, the effects of HTV ventilation in patients undergoing liver transplant (LT) has not been reported. The aim of this study was to determine if intraoperative HTV ventilation was associated with the development of acute respiratory distress syndrome (ARDS).
METHODS


Patients undergoing LT between 2013 and 2018 at a tertiary medical center were reviewed. The tidal volume was recorded at 3 time points: after anesthesia induction, before liver reperfusion, and at the end of surgery. Patients were divided into 2 groups: HTV (>10 mL/kg predicted body weight [pBW]) and non-HTV (≤10 mL/kg pBW). The 2 groups were compared. Independent risk factors were identified by multivariable logistic models.
RESULTS


Of 780 LT patients, 85 (10.9%) received HTV ventilation. Female sex and greater difference between actual body weight and pBW were independent risk factors for HTV ventilation. Patients who received HTV ventilation had a significantly higher incidence of ARDS (10.3% vs 3.9%; P = .01) than those who received non-HTV ventilation.
CONCLUSIONS


In this retrospective study, we showed that HTV ventilation during LT was common and was associated with a higher incidence of ARDS. Therefore, tidal volume should be carefully selected during LT surgery. More studies using a prospective randomized controlled design are needed.",2022,"Patients who received HTV ventilation had a significantly higher incidence of ARDS (10.3% vs 3.9%; P = .01) than those who received non-HTV ventilation.
","['acute respiratory distress syndrome (ARDS', 'Patients undergoing LT between 2013 and 2018 at a tertiary medical center were reviewed', 'patients undergoing liver transplant (LT', 'patients in the intensive care unit', 'and Postoperative Acute Respiratory Distress Syndrome in Liver Transplant']","['Intraoperative High Tidal Volume Ventilation', 'mechanical ventilation with high tidal volume (HTV', 'intraoperative HTV ventilation', 'HTV ventilation']","['tidal volume', 'incidence of ARDS', 'HTV ventilation']","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.0152518,"Patients who received HTV ventilation had a significantly higher incidence of ARDS (10.3% vs 3.9%; P = .01) than those who received non-HTV ventilation.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Yantaishan Hospital, Yantai, Shandong, P. R. China; Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Hofer', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nguyen-Buckley', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Disque', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wray', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA. Electronic address: vxia@mednet.ucla.edu.'}]",Transplantation proceedings,['10.1016/j.transproceed.2021.10.030']
531,35227669,Interdisciplinary Protocol for Surgery in Older Persons: Development and Implementation.,"As the population ages, more older adults will undergo surgical procedures, and common physiologic changes can raise the risk for surgical complications while increasing morbidity and mortality. In conjunction with the National Surgical Quality Improvement Program, we piloted a comprehensive and interdisciplinary assessment and intervention protocol for perioperative care for patients aged ≥75 years undergoing elective general, gynecology-oncologic, and orthopedic surgery. The intervention included screening tools for cognitive, functional, and nutritional deficits, a Geriatric Nurse Champion on each inpatient surgical unit, and an interdisciplinary Geriatric Surgery Quality Committee. Our intervention group was compared to surgical patients during the same time period 1 year prior to the intervention, and the groups were well matched in demographics and comorbidities. The intervention group had significantly higher rates of advance care plan documentation in analysis of all patients (P < .001) and in subgroup analysis of those 85 and older (P = .006). The preintervention group had less postoperative delirium compared to the postintervention group but it was not significant and there was no difference in length of stay between groups. Various explanations for the minimal impact of the protocol exist: small sample size, presence of other hospital initiatives to reduce pressure ulcer and delirium, and clinician's awareness of project planning that led to incorporating ideas prior to official implementation. Future research implementing this protocol in naïve and/or underperforming institutions may demonstrate a greater effect. Larger sample size as well as implementation in other surgical fields may reveal a significant impact. However, if additional study does not reveal a meaningful impact of a comprehensive geriatric assessment for surgical patients, then consideration must be made regarding unrecognized factors in surgical care for older adults or perhaps that factors cannot be mitigated in older adults because they are intrinsically a higher surgical risk.",2022,The intervention group had significantly higher rates of advance care plan documentation in analysis of all patients (P < .001) and in subgroup analysis of those 85 and older (P = .006).,"['Older Persons', 'patients aged ≥75\xa0years undergoing elective general, gynecology-oncologic, and orthopedic surgery']",['comprehensive and interdisciplinary assessment and intervention protocol'],"['postoperative delirium', 'rates of advance care plan documentation', 'length of stay']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C4544311', 'cui_str': 'Advance care plan'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0321403,The intervention group had significantly higher rates of advance care plan documentation in analysis of all patients (P < .001) and in subgroup analysis of those 85 and older (P = .006).,"[{'ForeName': 'Paula E', 'Initials': 'PE', 'LastName': 'Lester', 'Affiliation': 'NYU Long Island School of Medicine, Mineola, NY, USA. Electronic address: Paula.Lester@nyulangone.org.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Ripley', 'Affiliation': 'NYU Langone-Long Island Hospital, Mineola, NY, USA.'}, {'ForeName': 'Roseann', 'Initials': 'R', 'LastName': 'Grandelli', 'Affiliation': 'NYU Langone-Long Island Hospital, Mineola, NY, USA.'}, {'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Drew', 'Affiliation': 'NYU Langone-Long Island Hospital, Mineola, NY, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Keegan', 'Affiliation': 'NYU Langone-Long Island Hospital, Mineola, NY, USA.'}, {'ForeName': 'Shahidul', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'NYU Long Island School of Medicine, Mineola, NY, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2022.01.070']
532,35235859,Improvement of inflammatory status following saffron (Crocus sativus L.) and resistance training in elderly hypertensive men: A randomized controlled trial.,"OBJECTIVE


We sought to determine the independent and combined effects of saffron and resistance training on markers of inflammation and cardiovascular risk factors in elderly hypertensive patients.
METHODS


Hypertensive older men were randomly assigned to a control group (C) or one of three experimental groups [saffron consumption (S), resistance training (R), and resistance training + saffron (RS)] for 12 weeks. Inflammatory markers and lipid profiles were measured at baseline and following the 12-week intervention period. Patients in S and RS received one tablet containing 200 mg of saffron daily. Primary outcomes were analyzed using univariate analysis of covariance (ANCOVA).
RESULTS


The RS group had significantly greater reductions in leptin, resistin, MCP-1, and IL-6 as compared with the C, S, and R groups (ps < 0.05). In addition, the RS, S, and R groups had significantly greater reductions in TC and greater increases in HDL-c as compared with the C group (ps < 0.05), but there were no differences between the RS, S, and R groups. Finally, there were no differences between groups for TNF-α, homocysteine, and hs-CRP (ps > 0.05).
CONCLUSION


Combining Saffron and resistance training can reduce inflammation and cardiovascular disease risk factors associated with increased risk for hypertension in older men with hypertension.",2022,"The RS group had significantly greater reductions in leptin, resistin, MCP-1, and IL-6 as compared with the C, S, and R groups (ps < 0.05).","['elderly hypertensive patients', 'elderly hypertensive men', 'older men with hypertension', 'Hypertensive older men']","['saffron (Crocus sativus L.) and resistance training', 'Saffron and resistance training', 'saffron and resistance training', 'control group (C) or one of three experimental groups [saffron consumption (S), resistance training (R), and resistance training + saffron (RS']","['Inflammatory markers and lipid profiles', 'leptin, resistin, MCP-1, and IL-6', 'HDL-c', 'TNF-α, homocysteine, and hs-CRP']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0946614', 'cui_str': 'Saffron Crocus'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",,0.0413858,"The RS group had significantly greater reductions in leptin, resistin, MCP-1, and IL-6 as compared with the C, S, and R groups (ps < 0.05).","[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Mojtahedi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand-Moghadam', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran. Electronic address: babak.hooshmand@mail.um.ac.ir.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rosenkranz', 'Affiliation': 'School of Science and Health, University of Western Sydney, Sydney, Australia; Department of Food, Nutrition, Dietetics and Health, Kansas State University, Manhattan, KS, USA.'}, {'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Shourideh', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Amirshaghaghi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shabkhiz', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}]",Experimental gerontology,['10.1016/j.exger.2022.111756']
533,35235823,Conducting a representative national randomized control trial of tailored clinical decision support for nurses remotely: Methods and implications.,"Clinical Decision Support (CDS) systems, patient specific evidence delivered to clinicians via the electronic health record (EHR) at the right time and in the right format, has the potential to improve patient outcomes. Unfortunately, outcomes of CDS research are mixed. A potential cause lies in its testing. Many CDS are implemented in practice without sufficient testing, potentially leading to patient harm. When testing is conducted, most research has focused on ""what"" evidence to provide with little attention to the impact of the CDS display format (e.g., textual, graphical) on the user. In an adequately powered randomized control trial with 220 hospital based registered nurses, we will compare 4 randomly assigned CDS format groups (text, text table, text graphs, tailored to subject's graph literacy score) for effects on decision time and simulated patient outcomes. We recruit using state based professional registries, which allows access to participants from multiple institutions across the nation. We use online survey software (REDCap) for efficient study workflow including screening, informed consent documentation, pre-experiment demographic data collection including a graph literacy questionnaire used in randomization. The CDS prototype is accessed via a web app and the simulation-based experiment is conducted remotely at a subject's local computer using video-conferencing software. Also included are 6 post intervention surveys to assess cognitive workload, usability, numeracy, format preference, CDS utilization rationale, and CDS interpretation. Our methods are replicable and scalable for testing of health information technologies and have the potential to improve the safety and effectiveness of these technologies across disciplines.",2022,Our methods are replicable and scalable for testing of health information technologies and have the potential to improve the safety and effectiveness of these technologies across disciplines.,['220 hospital based registered nurses'],['online survey software (REDCap'],"['cognitive workload, usability, numeracy, format preference, CDS utilization rationale, and CDS interpretation']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}]",220.0,0.102517,Our methods are replicable and scalable for testing of health information technologies and have the potential to improve the safety and effectiveness of these technologies across disciplines.,"[{'ForeName': 'Karen Dunn', 'Initials': 'KD', 'LastName': 'Lopez', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA. Electronic address: Karen-dunn-lopez@uiowa.edu.'}, {'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: y.yao@ufl.edu.'}, {'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: hcho@ufl.edu.'}, {'ForeName': 'Fabiana Cristina Dos', 'Initials': 'FCD', 'LastName': 'Santos', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: fabianadossantos@ufl.edu.'}, {'ForeName': 'Olatunde O', 'Initials': 'OO', 'LastName': 'Madandola', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: omadandola@ufl.edu.'}, {'ForeName': 'Ragnhildur I', 'Initials': 'RI', 'LastName': 'Bjarnadottir', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: rib@ufl.edu.'}, {'ForeName': 'Tamara Goncalves Rezende', 'Initials': 'TGR', 'LastName': 'Macieira', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: tmacie2@ufl.edu.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Garcia', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: amanda.garcia@ufl.edu.'}, {'ForeName': 'Karen J B', 'Initials': 'KJB', 'LastName': 'Priola', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: kbyer@ufl.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA. Electronic address: jessica-s-wolf@uiowa.edu.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Bian', 'Affiliation': 'College of Medicine, Health Outcomes & Biomedical Informatics, University of Florida, Gainesville, FL, USA. Electronic address: bianjiang@ufl.edu.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: diwilkie@ufl.edu.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Keenan', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: gkeenan@ufl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106712']
534,35238805,"The Knee Injury and Osteoarthritis Outcome Score Does Not Have Adequate Structural Validity for Use With Young, Active Patients With ACL Tears.","BACKGROUND


The Knee Injury and Osteoarthritis Outcome Score (KOOS) is well known and commonly used to assess young, active patients with ACL injuries. However, this application of the outcome measure has been called into question. There is currently no evidence supporting the structural validity of the KOOS for this patient population. Structural validity refers to whether a questionnaire meant to provide scores on different subscales behaves as intended in the populations of interest. Structural validity should be assessed for all questionnaire measures with multiple items or subscales.
QUESTIONS/PURPOSES


Does the KOOS demonstrate adequate structural validity in young, active patients with ACL tears, when evaluated using (1) exploratory and (2) confirmatory factor analyses?
METHODS


Between January 2014 and March 2017, 1033 patients were screened for eligibility in the Stability 1 randomized controlled trial from nine centers in Canada and Europe. Patients were eligible if they had an ACL deficient knee, were between 14 and 25 years old, and were thought to be at higher risk of reinjury based on the presence of two or more of the following factors: participation in pivoting sports, presence of a Grade 2 pivot shift or greater, generalized ligamentous laxity (Beighton score of 4 or greater), or genu recurvatum greater than 10°. Based on this criteria, 367 patients were ineligible and another 48 declined to participate. In total, 618 patients were randomized into the trial. Of the trial participants, 98% (605 of 618) of patients had complete baseline KOOS questionnaire data available for this analysis. Based on study inclusion criteria, the baseline KOOS data from the Stability 1 trial represents an appropriate sample to investigate the structural validity of the KOOS, specifically for the young, active ACL deficient population.A cross sectional retrospective secondary data analysis of the Stability 1 baseline KOOS data was completed to assess the structural validity of the KOOS using exploratory and confirmatory factor analyses. Exploratory factor analysis investigates how all questionnaire items group together based on their conceptual similarity in a specific sample. Confirmatory factor analysis is similar but used often in a second stage to test and confirm a proposed structure of the subscales. These methods were used to assess the established five-factor structure of the KOOS (symptoms [seven items], pain [nine items], activities of daily living [17 items], sport and recreation [five items], and quality of life [four items]) in young active patients with ACL tears. Incremental posthoc modifications, such as correlating questionnaire items or moving items to different subscales, were made to the model structure until adequate fit was achieved. Model fit was assessed using chi-square, root mean square error of approximation (RMSEA) and an associated 90% confidence interval, comparative fit index (CFI), Tucker-Lewis index (TLI), as well as standardized root mean square residual (SRMR). Adequate fit was defined as a CFI and TLI > 0.9, and RMSEA and SRMR < 0.08.
RESULTS


Structural validity of the KOOS was not confirmed when evaluated using (1) exploratory or (2) confirmatory factor analyses. The exploratory factor analysis, where the 42 KOOS items were allowed to group naturally, did not reflect adequate fit for a five-factor model (TLI = 0.828). Similarly, the confirmatory factor analysis used to investigate the KOOS structure as it was originally developed, revealed inadequate fit in our sample (RMSEA = 0.088 [90% CI 0.086 to 0.091]). Our analysis suggested a modified four-factor structure may be more appropriate in young, active ACL deficient patients; however, the final version presented here is not appropriate for clinical use because of the number and nature of post-hoc modifications required to reach adequate fit indices.
CONCLUSION


The established five-factor structure of the KOOS did not hold true in our sample of young, active patients undergoing ACL reconstruction, indicating poor structural validity.
CLINICAL RELEVANCE


We question the utility and interpretability of KOOS subscale scores for young, active patients with ACL tears with the current form of the KOOS. A modified version of the KOOS, adjusted for this patient population, is needed to better reflect and interpret the outcomes and recovery trajectory in this high-functioning group. A separate analysis with a defined a priori development plan would be needed to create a valid alternative.",2022,"RESULTS


Structural validity of the KOOS was not confirmed when evaluated using (1) exploratory or (2) confirmatory factor analyses.","['young, active patients with ACL tears with the current form of the KOOS', 'Patients were eligible if they had an ACL deficient knee, were between 14 and 25 years old, and were thought to be at higher risk of reinjury based on the presence of two or more of the following factors: participation in pivoting sports, presence of a Grade 2 pivot shift or greater, generalized ligamentous laxity (Beighton score of 4 or greater), or genu recurvatum greater than 10°', 'Between January 2014 and March 2017, 1033 patients were screened for eligibility in the Stability 1 randomized controlled trial from nine centers in Canada and Europe', '367 patients were ineligible and another 48 declined to participate', 'young active patients with ACL tears', 'young, active patients with ACL injuries', '618 patients']",[],"['comparative fit index (CFI), Tucker-Lewis index (TLI), as well as standardized root mean square residual (SRMR', 'KOOS subscale scores', 'pain [nine items], activities of daily living [17 items], sport and recreation [five items], and quality of life [four items']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0086437', 'cui_str': 'Joint laxity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152235', 'cui_str': 'Congenital genu recurvatum'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}]",[],"[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",618.0,0.0516867,"RESULTS


Structural validity of the KOOS was not confirmed when evaluated using (1) exploratory or (2) confirmatory factor analyses.","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Marmura', 'Affiliation': 'Faculty of Health Sciences, Western University, London, ON, Canada.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Tremblay', 'Affiliation': 'Department of Psychology, Western University, London, ON, Canada.'}, {'ForeName': 'Alan M J', 'Initials': 'AMJ', 'LastName': 'Getgood', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Bryant', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000002158']
535,35240345,An informative video before planned cesarean delivery and maternal anxiety-a multicenter randomized controlled trial.,"BACKGROUND


Cesarean delivery is one of the most common procedures performed in obstetrics, and although cesarean delivery is a blissful occasion, it is commonly associated with fear and anxiety for the new mother.
OBJECTIVE


We aimed to study the impact of watching a detailed, informative video on maternal anxiety levels, childbirth experience, and patient satisfaction in patients undergoing a primary cesarean delivery.
STUDY DESIGN


We performed a multicenter randomized control trial. Women scheduled to undergo a primary nonemergent cesarean delivery were recruited. All participants in the intervention group watched an informative video on recruitment. This 4-minute video described in detail the expected cesarean delivery process: preparations before entering the operation room, regional anesthesia administration, sterile covering, the surgical procedure itself, and recovery (including mobilization and lactation). Situation-specific anxiety was measured at recruitment, before exposure to the video (S1), at the day of the operation (S2), and at postpartum day 1 (S3) using the State-Trait Anxiety Inventory score. In addition, participants answered a 10-item Childbirth Experience Questionnaire. A sample size of 63 per group was planned to achieve 80% power to detect a difference of 5 points in the primary outcome (State-Trait Anxiety Inventory score on the day of the operation).
RESULTS


Overall, 154 participants from 4 medical centers were randomized, and 132 participants were analyzed after completing all questionnaires, 64 participants in the video group and 68 participants in the control group. The groups did not differ in demographics and delivery characteristics and had similar baseline anxiety levels (S1). On operation day (S2, the primary outcome), significantly lower anxiety levels were reported in the video group than in the control group (State-Trait Anxiety Inventory scores, 41.3±9.5 vs 49.3±10.3; P<.001). Moreover, anxiety levels in postpartum day 1 (S3) remained significantly lower in the video group (P<.001). No difference between the groups in childbirth experience score or patient satisfaction was demonstrated.
CONCLUSION


A detailed informative video shown to patients before primary cesarean delivery decreased maternal anxiety levels before and after the procedure.",2022,"On operation day (S2, the primary outcome), significantly lower anxiety levels were reported in the video group compared to the control group (STAI scores 41.3±9.5 vs. 49.3±10.3, p<0.001).","['Patients scheduled to undergo a primary non-emergent CD were recruited', 'patients undergoing a primary CD', '154 patients from 4 medical centers were randomized, and 132 patients were analyzed after completing all questionnaires, 64 patients in the video group and 68 patients in the control group']",[],"['baseline anxiety levels (S1', 'anxiety levels', 'maternal anxiety', 'Situation-specific anxiety', 'lower anxiety levels', 'State-Trait Anxiety Inventory (STAI) score', 'childbirth experience score or patient satisfaction']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",154.0,0.141789,"On operation day (S2, the primary outcome), significantly lower anxiety levels were reported in the video group compared to the control group (STAI scores 41.3±9.5 vs. 49.3±10.3, p<0.001).","[{'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Miremberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, Israel (Drs Miremberg, Ganor Paz, and Weiner); Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (Drs Miremberg and Weiner). Electronic address: dasile2@gmail.com.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Yirmiya', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat Gan, Israel (Dr Yirmiya); Interdisciplinary Center, Herzliya, Israel (Dr Yirmiya).'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Vinter', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel (Drs Vinter and Lauterbach); The Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel (Drs Vinter and Lauterbach).'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Lauterbach', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel (Drs Vinter and Lauterbach); The Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel (Drs Vinter and Lauterbach).'}, {'ForeName': 'Enav', 'Initials': 'E', 'LastName': 'Yefet', 'Affiliation': 'Department of Obstetrics and Gynecology, Baruch Padeh Medical Center, Poriya, Tiberias, Israel (Drs Yefet and Nassra); Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel (Dr Yefet).'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Nassra', 'Affiliation': 'Department of Obstetrics and Gynecology, Baruch Padeh Medical Center, Poriya, Tiberias, Israel (Drs Yefet and Nassra).'}, {'ForeName': 'Yael Ganor', 'Initials': 'YG', 'LastName': 'Paz', 'Affiliation': ""Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, Israel (Drs Miremberg, Ganor Paz, and Weiner); Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel (Drs Ganor Paz and Hagege); Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (Dr Ganor Paz).""}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hagege', 'Affiliation': 'Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel (Drs Ganor Paz and Hagege).'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': 'Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, Israel (Drs Miremberg, Ganor Paz, and Weiner); Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (Drs Miremberg and Weiner).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100604']
536,35247334,"A Randomized, Double-Masked, Multicenter Trial of Topical Acrizanib (LHA510), a Tyrosine Kinase VEGF-Receptor Inhibitor, in Treatment-Experienced Subjects With Neovascular Age-Related Macular Degeneration.","PURPOSE


To evaluate whether topical acrizanib (LHA510), a small-molecule vascular endothelial growth factor receptor inhibitor, could suppress the need for anti-vascular endothelial growth factor therapy over a 12-week period in patients with neovascular age-related macular degeneration.
DESIGN


A phase 2 multicenter randomized double-masked, vehicle-controlled proof-of-concept study.
METHODS


Trial includes n = 90 patients with active choroidal neovascularization due to neovascular age-related macular degeneration and under anti-vascular endothelial growth factor treatment. All patients received an intravitreal injection of ranibizumab at baseline and were retreated when there was evidence of disease recurrence (rescue). Patients were randomized 1:1 to receive topical LHA510 or vehicle for 12 weeks. Drops were administered twice a day for 8 weeks and then 3 times a day for the last 4 weeks.
MAIN OUTCOME MEASURE


The primary outcome was the number of patients requiring rescue over 84 days of topical dosing. Key secondary outcome measures were time to first rescue, total number of ranibizumab injections, changes in central subfield thickness, and changes of visual acuity from baseline to day 84.
RESULTS


The extended per protocol set included 70 patients of whom 25 of 33 patients in the LHA510 group (75.8%) and 25 of 37 patients in the placebo group (67.6%) required rescue by day 84 (P = .8466). Secondary and subgroup analysis did not support evidence of efficacy. Twenty-one of 46 patients administered LHA510 developed a reversible corneal haze that resolved with cessation of treatment and did not recur in patients restarted at once daily frequency.
CONCLUSION


In spite of extensive optimization for topical efficacy, LHA510 failed to demonstrate clinical efficacy.",2022,Twenty-one of 46 patients administered LHA510 developed a reversible corneal haze that resolved with cessation of treatment and did not recur in patients restarted at once daily frequency CONCLUSIONS:,"['patients with neovascular age-related macular degeneration (nAMD) DESIGN', 'seventy patients of whom 25 of 33 patients in the LHA510 group (75.8%) and 25 of 37 patients in the', ' Trial includes n\u202f=\u202f90 patients with active choroidal neovascularization due to nAMD and under anti-VEGF treatment', 'subjects with neovascular age-related macular degeneration']","['intravitreal injection of ranibizumab', 'placebo', 'LHA510', 'topical LHA510', 'topical acrizanib (LHA510', 'topical acrizanib (LHA510), a tyrosine kinase VEGF-receptor inhibitor']","['number of patients requiring rescue over 84 days of topical dosing', 'efficacy', 'time to first rescue, total number of ranibizumab injections, changes in central subfield thickness (CSFT) and changes of visual acuity', 'reversible corneal haze']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C4742748', 'cui_str': 'LHA510'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4742748', 'cui_str': 'LHA510'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4742747', 'cui_str': 'acrizanib'}, {'cui': 'C0033681', 'cui_str': 'Protein-tyrosine kinase'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0010038', 'cui_str': 'Corneal opacity'}]",90.0,0.742093,Twenty-one of 46 patients administered LHA510 developed a reversible corneal haze that resolved with cessation of treatment and did not recur in patients restarted at once daily frequency CONCLUSIONS:,"[{'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Poor', 'Affiliation': 'From the Translational Medicine/Research (S.H.P., C.L.G.). Electronic address: stephen.poor@novartis.com.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Weissgerber', 'Affiliation': 'Clinical Development (G.W., G.N.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Adams', 'Affiliation': 'Global Discovery Chemistry (C.M.A.).'}, {'ForeName': 'Harit', 'Initials': 'H', 'LastName': 'Bhatt', 'Affiliation': 'Retina and Macula Associates, Oak Forest (H.B.); University of Illinois, Chicago (H.B.), Illinois.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Browning', 'Affiliation': 'Charlotte Eye, Ear, Nose, and Throat Associates, Charlotte, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chastain', 'Affiliation': 'PK Sciences (J.C.).'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Ciulla', 'Affiliation': 'Clearside Biomedical Inc, Alpharetta, Georgia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ferriere', 'Affiliation': 'Clinical Data Operations (M.F.).'}, {'ForeName': 'Kinfemichael', 'Initials': 'K', 'LastName': 'Gedif', 'Affiliation': 'Biostatistician, Novartis Pharma Inc (K.G.), Basel, Switzerland.'}, {'ForeName': 'Louis C', 'Initials': 'LC', 'LastName': 'Glazer', 'Affiliation': 'Vitreo-Retinal Associates, Grand Rapids, Michigan.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Joondeph', 'Affiliation': 'Colorado Retina Associates, Denver, Colorado, USA.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Normand', 'Affiliation': 'Clinical Development (G.W., G.N.); East Hanover, New Jersey (G.N.).'}, {'ForeName': 'Veeral', 'Initials': 'V', 'LastName': 'Sheth', 'Affiliation': 'Retina and Macula Associates, Oak Forest (H.B.); University of Illinois, Chicago (H.B.), Illinois.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Watters', 'Affiliation': 'and Biostatistician (C.W., C.L.G.), Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, USA (C.W., C.L.G.); Biostatistician, Novartis Pharma Inc (K.G.), Basel, Switzerland.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Grosskreutz', 'Affiliation': 'From the Translational Medicine/Research (S.H.P., C.L.G.); Biostatistician, Novartis Pharma Inc (K.G.), Basel, Switzerland.'}]",American journal of ophthalmology,['10.1016/j.ajo.2022.02.019']
537,35249833,The Effect of Erector Spinae Plane Block and Combined Deep and Superficial Serratus Anterior Plane Block on Acute Pain After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Study.,"OBJECTIVE


The study aimed to compare the analgesic effects of erector spinae plane block (ESPB) and a combination of the deep and superficial serratus anterior plane block (C-SAPB) methods in patients who underwent video-assisted thoracoscopic surgery (VATS).
DESIGN


A prospective, randomized study.
SETTING


At a single-center, high-volume, tertiary thoracic surgery center.
PARTICIPANTS


Adult patients undergoing VATS.
INTERVENTIONS


Ultrasound-guided ESPB and C-SAPB.
MEASUREMENTS AND MAIN RESULTS


Patients were assigned to ESPB (group 1) or C-SAPB (group 2) groups according to the analgesia protocol. All interventions were performed with single-needle insertion. Multimodal analgesia was achieved via paracetamol, dexketoprofen, and intravenous morphine for both study groups. Pain scores were assessed by the visual analog scale (VAS). Morphine consumption, rescue analgesic requirements, and side effects were recorded postoperatively for 24 hours. The primary outcome was determined as VAS scores at rest and coughing. The secondary outcomes of this study were postoperative morphine consumption and the requirement of rescue analgesics. There was no statistically significant difference between the groups in terms of VAS scores (p > 0.05). The groups also were similar in terms of demographic characteristics, side effects, morphine consumption, additional analgesic use, and duration of block procedures (p > 0.05). There also were comparable results in terms of hemodynamic variables (p > 0.05).
CONCLUSIONS


Patients who underwent VATS receiving ESPB or C-SAPB had similar pain scores, opioid consumption, and side effects during the first postoperative 24 hours. At the same time, the fact that the duration of the block procedure was similar in both groups showed that multisite serratus anterior plane block can be an effective alternative method in analgesic treatment after VATS, considering that it easily can be applied. The authors here think that C-SAPB can be a good alternative to ESPB because the outcomes of both applications are similar, and C-SAPB easily can be seen and applied with ultrasound.",2022,"The groups also were similar in terms of demographic characteristics, side effects, morphine consumption, additional analgesic use, and duration of block procedures (p > 0.05).","['patients who underwent video-assisted thoracoscopic surgery (VATS', 'Adult patients undergoing VATS']","['morphine', 'ESPB', 'erector spinae plane block (ESPB) and a combination of the deep and superficial serratus anterior plane block (C-SAPB', 'Erector Spinae Plane Block and Combined Deep and Superficial Serratus Anterior Plane Block', 'Video-Assisted Thoracoscopic Surgery', 'paracetamol, dexketoprofen']","['Morphine consumption, rescue analgesic requirements, and side effects', 'VAS scores at rest and coughing', 'Pain scores', 'Acute Pain', 'pain scores, opioid consumption, and side effects', 'demographic characteristics, side effects, morphine consumption, additional analgesic use, and duration of block procedures', 'visual analog scale (VAS', 'hemodynamic variables', 'VAS scores', 'postoperative morphine consumption and the requirement of rescue analgesics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0483815,"The groups also were similar in terms of demographic characteristics, side effects, morphine consumption, additional analgesic use, and duration of block procedures (p > 0.05).","[{'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Zengin', 'Affiliation': 'University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey. Electronic address: musazengin@gmail.com.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Sazak', 'Affiliation': 'University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey.'}, {'ForeName': 'Ramazan', 'Initials': 'R', 'LastName': 'Baldemir', 'Affiliation': 'University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey.'}, {'ForeName': 'Gulay', 'Initials': 'G', 'LastName': 'Ulger', 'Affiliation': 'University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alagoz', 'Affiliation': 'University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2022.01.048']
538,35253265,"Model-assisted analyses of longitudinal, ordinal outcomes with absorbing states.","Studies of critically ill, hospitalized patients often follow participants and characterize daily health status using an ordinal outcome variable. Statistically, longitudinal proportional odds models are a natural choice in these settings since such models can parsimoniously summarize differences across patient groups and over time. However, when one or more of the outcome states is absorbing, the proportional odds assumption for the follow-up time parameter will likely be violated, and more flexible longitudinal models are needed. Motivated by the VIOLET Study (Ginde et al), a parallel-arm, randomized clinical trial of Vitamin      D   3        in critically ill patients, we discuss and contrast several treatment effect estimands based on time-dependent odds ratio parameters, and we detail contemporary modeling approaches. In VIOLET, the outcome is a four-level ordinal variable where the lowest ""not alive"" state is absorbing and the highest ""at-home"" state is nearly absorbing. We discuss flexible extensions of the proportional odds model for longitudinal data that can be used for either model-based inference, where the odds ratio estimator is taken directly from the model fit, or for model-assisted inferences, where heterogeneity across cumulative log odds dichotomizations is modeled and results are summarized to obtain an overall odds ratio estimator. We focus on direct estimation of cumulative probability model (CPM) parameters using likelihood-based analysis procedures that naturally handle absorbing states. We illustrate the modeling procedures, the relative precision of model-based and model-assisted estimators, and the possible differences in the values for which the estimators are consistent through simulations and analysis of the VIOLET Study data.",2022,"We illustrate the modeling procedures, the relative precision of model-based and model-assisted estimators, and the possible differences in the values for which the estimators are consistent through simulations and analysis of the VIOLET Study data.",['critically ill patients'],[],[],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0845687,"We illustrate the modeling procedures, the relative precision of model-based and model-assisted estimators, and the possible differences in the values for which the estimators are consistent through simulations and analysis of the VIOLET Study data.","[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Schildcrout', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington School of Public Health, Seattle, Washington, USA.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Haneuse', 'Affiliation': 'Department of Biostatistics, T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, USA.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Di Gravio', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Shawn P', 'Initials': 'SP', 'LastName': 'Garbett', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Rathouz', 'Affiliation': 'Department of Population Health, Dell Medical Center, University of Texas, Austin, Texas, USA.'}, {'ForeName': 'Bryan E', 'Initials': 'BE', 'LastName': 'Shepherd', 'Affiliation': 'Department of Biostatistics, University of Washington School of Public Health, Seattle, Washington, USA.'}]",Statistics in medicine,['10.1002/sim.9366']
539,35256203,Effects of Neuromuscular Electrical Stimulation on Lower Limb Muscle Strength After Living Donor Liver Transplant: A Case-Control Study.,"BACKGROUND


Early mobilization after liver transplant (LT) plays an important role in postoperative recovery and complication prevention; however, patients undergoing LT cannot achieve early mobilization because of mechanical ventilation and poor preoperative physical performance. We investigated the effect of neuromuscular electrical stimulation (NMES) on lower limb muscle strength after living donor liver transplant (LDLT).
METHODS


Adult patients who underwent LDLT between December 2016 and January 2019 at a university hospital were recruited. A consecutive series of patients who underwent LDLT without NMES therapy before the clinical trial (April 2014-May 2016) were enrolled as the non-NMES (control) group. Patients in the NMES group received NMES on the quadriceps muscles starting 1 day post LDLT for 4 weeks. The study was conducted in accordance with the Declaration of Helsinki, and all patients provided informed consent.
RESULTS


Twenty-four patients in the NMES group and 16 patients in the non-NMES group were analyzed. There was no significant difference between groups regarding changes in any outcome.
CONCLUSIONS


The application of NMES in patients with LDLT did not yield greater improvement of muscle strength, functional capacity, activities of daily living, or length of hospital stay 4 weeks postoperatively compared with the control group. However, developing a novel NMES device and confirming whether additional NMES is effective for other body areas may yield different results.",2022,"The application of NMES in patients with LDLT did not yield greater improvement of muscle strength, functional capacity, activities of daily living, or length of hospital stay 4 weeks postoperatively compared with the control group.","['patients with LDLT', 'after living donor liver transplant (LDLT', 'therapy before the clinical trial (April 2014-May 2016) were enrolled as the non-NMES (control) group', 'liver transplant', 'Adult patients who underwent LDLT between December 2016 and January 2019 at a university hospital were recruited', 'After Living Donor Liver Transplant']","['LDLT without NMES', 'Neuromuscular Electrical Stimulation', 'NMES', 'neuromuscular electrical stimulation (NMES']","['lower limb muscle strength', 'muscle strength, functional capacity, activities of daily living, or length of hospital stay', 'Lower Limb Muscle Strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3544287', 'cui_str': 'Living donor liver transplant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C3544287', 'cui_str': 'Living donor liver transplant'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0210949,"The application of NMES in patients with LDLT did not yield greater improvement of muscle strength, functional capacity, activities of daily living, or length of hospital stay 4 weeks postoperatively compared with the control group.","[{'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Hattori', 'Affiliation': 'Department of Rehabilitation, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yota', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Department of Rehabilitation, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Ogura', 'Affiliation': 'Department of Transplantation Surgery, Nagoya University Hospital, Nagoya, Japan. Electronic address: oguchan@med.nagoya-u.ac.jp.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Rehabilitation, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Nagaya', 'Affiliation': 'Department of Rehabilitation, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Jobara', 'Affiliation': 'Department of Transplantation Surgery, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Kurata', 'Affiliation': 'Department of Transplantation Surgery, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nishida', 'Affiliation': 'Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",Transplantation proceedings,['10.1016/j.transproceed.2022.01.028']
540,35256194,Association of research timing with surgery resident perceptions of operative autonomy and satisfaction: A multi-institutional study.,"BACKGROUND


General surgery residents commonly engage in research years after the second (Post-postgraduate year 2 [PostPGY2]) or third (PostPGY3) clinical training year. The impact of dedicated research training timing on training experience is unknown. Our aim was to examine the progression of residents' perceived meaningful operative autonomy and evaluate career satisfaction, in relation to research timing.
METHODS


Categorical surgery residents with 2-year research requirements were surveyed regarding perceived autonomy for laparoscopic appendectomy, laparoscopic cholecystectomy, and right hemicolectomy and satisfaction with the impact of dedicated research training on professional development. Meaningful operative autonomy was defined as Zwisch scores ≥3 (passive help or supervision only).
RESULTS


Residents from 17 programs participated (n = 233, 30.6%); 48% were PostPGY2. PostPGY3 residents were more likely to perceive meaningful operative autonomy when starting dedicated research training (laparoscopic appendectomy: 98% vs 74%, P < .001; laparoscopic cholecystectomy: 87% vs 48%, P < .001; right hemicolectomy: 27% vs 3%, P < .001). Meaningful operative autonomy declined during dedicated research training but was still higher for PostPGY3 residents for laparoscopic appendectomy (84% vs 42%, P < .001) and laparoscopic cholecystectomy (68% vs 30%, P < .001). By PGY4, PostPGY2 residents reported rates of meaningful operative autonomy comparable to PostPGY3 through training completion. A higher proportion of PostPGY3 residents reported dedicated research training satisfaction (90% vs 78%, P = .01). Training at PostPGY3 programs (odds ratio, 3.06, 95% confidence interval, 1.38-6.80) and postresearch training stage (compared with preresearch residents, odds ratio, 3.25, 95% confidence interval, 1.06-10.0) were independently associated with satisfaction.
CONCLUSION


Significant differences existed in the progression of perceived operative autonomy and dedicated research training satisfaction between PostPGY2 and PostPGY3 residents. These results could help surgical educators make individualized decisions regarding research timing to promote surgical skill acquisition and resident well-being.",2022,"Training at PostPGY3 programs (odds ratio, 3.06, 95% confidence interval, 1.38-6.80) and postresearch training stage (compared with preresearch residents, odds ratio, 3.25, 95% confidence interval, 1.06-10.0) were independently associated with satisfaction.
","['Residents from 17 programs participated (n\xa0= 233, 30.6%); 48% were PostPGY2', 'Categorical surgery residents with 2-year research requirements were surveyed regarding perceived autonomy for laparoscopic appendectomy, laparoscopic cholecystectomy, and right hemicolectomy and satisfaction with the impact of dedicated research training on professional development']",[],"['research training satisfaction', 'meaningful operative autonomy', 'laparoscopic cholecystectomy', 'Meaningful operative autonomy', 'postresearch training stage']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",[],"[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",,0.0376114,"Training at PostPGY3 programs (odds ratio, 3.06, 95% confidence interval, 1.38-6.80) and postresearch training stage (compared with preresearch residents, odds ratio, 3.25, 95% confidence interval, 1.06-10.0) were independently associated with satisfaction.
","[{'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, CA. Electronic address: mschumm@mednet.ucla.edu.'}, {'ForeName': 'Ivy A', 'Initials': 'IA', 'LastName': 'Huang', 'Affiliation': 'Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, CA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Blair', 'Affiliation': 'Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, CA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Nameth', 'Affiliation': ""Dean's Office, Faculty Professional Development Unit, David Geffen School of Medicine, University of California Los Angeles, CA.""}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, CA.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Quach', 'Affiliation': 'Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, CA.'}, {'ForeName': 'Justin P', 'Initials': 'JP', 'LastName': 'Wagner', 'Affiliation': 'Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, CA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, CA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Donahue', 'Affiliation': 'Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, CA.'}, {'ForeName': 'Areti', 'Initials': 'A', 'LastName': 'Tillou', 'Affiliation': 'Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, CA.'}]",Surgery,['10.1016/j.surg.2022.01.045']
541,35258487,Democratizing Flexible Endoscopy Training: Noninferiority Randomized Trial Comparing a Box-Trainer vs a Virtual Reality Simulator to Prepare for the Fundamental of Endoscopic Surgery Exam.,"BACKGROUND


A considerable number of surgical residents fail the mandated endoscopy exam despite having completed the required clinical cases. Low-cost endoscopy box trainers (BTs) could democratize training; however, their effectiveness has never been compared with higher-cost virtual reality simulators (VRSs).
STUDY DESIGN


In this randomized noninferiority trial, endoscopy novices trained either on the VRS used in the Fundamental of Endoscopic Surgery manual skills (FESms) exam or a validated BT-the Basic Endoscopic Skills Training (BEST) box. Trainees were tested at fixed timepoints on the FESms and on standardized ex vivo models. The primary endpoint was FESms improvement at 1 week. Secondary endpoints were FESms improvement at 2 weeks, FESms pass rates, ex vivo tests performance, and trainees' feedback.
RESULTS


Seventy-seven trainees completed the study. VRS and BT trainees showed comparable FESms improvements (25.16 ± 14.29 vs 25.58 ± 11.75 FESms points, respectively; p = 0.89), FESms pass rates (76.32% vs 61.54%, respectively; p = 0.16) and total ex vivo tasks completion times (365.76 ± 237.56 vs 322.68 ± 186.04 seconds, respectively; p = 0.55) after 1 week. Performances were comparable also after 2 weeks of training, but FESms pass rates increased significantly only in the first week. Trainees were significantly more satisfied with the BT platform (3.97 ± 1.20 vs 4.81 ± 0.40 points on a 5-point Likert scale for the VRS and the BT, respectively; p < 0.001).
CONCLUSIONS


Simulation-based training is an effective means to develop competency in endoscopy, especially at the beginning of the learning curve. Low-cost BTs like the BEST box compare well with high-tech VRSs and could help democratize endoscopy training.",2022,"VRS and BT trainees showed comparable FESms improvements (25.16±14.29 vs 25.58±11.75 FESms points, respectively; p=0.89), FESms pass rates (76.32% vs 61.54%, respectively; p=0.16) and total ex-vivo tasks completion times (365.76±237.56 vs 322.68±186.04 seconds, respectively; p=0.55) after one week.",['77 trainees completed the study'],"['Endoscopic Surgery manual skills (FESms) exam, or a validated BT, the Basic Endoscopic Skills Training (BEST) box', 'Box-Trainer vs a Virtual Reality Simulator', 'Democratizing Flexible Endoscopy Training', 'Simulation-based training']","['total ex-vivo tasks completion times', 'FESms pass rates', ""FESms improvement at 2 weeks, FESms pass rates, ex-vivo tests performance and trainees' feedback"", 'FESms improvements', 'FESms improvement']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",77.0,0.0519824,"VRS and BT trainees showed comparable FESms improvements (25.16±14.29 vs 25.58±11.75 FESms points, respectively; p=0.89), FESms pass rates (76.32% vs 61.54%, respectively; p=0.16) and total ex-vivo tasks completion times (365.76±237.56 vs 322.68±186.04 seconds, respectively; p=0.55) after one week.","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Mascagni', 'Affiliation': 'From the Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy (Mascagni, Fiorillo).'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Spota', 'Affiliation': 'IRCAD, Research Institute Against Digestive Cancer, Strasbourg, France (Spota, Laracca, Dallemagne, Marescaux, Perretta).'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Pizzicannella', 'Affiliation': 'Institut Hospitalo-Universitaire (IHU), Institute of Image-Guided Surgery, Strasbourg, France (Mascagni, Pizzicannella, Fiorillo, Lim, Oudkerk Pool, Dallemagne, Swanstrom, Shlomovitz, Perretta).'}, {'ForeName': 'Giovanni Guglielmo', 'Initials': 'GG', 'LastName': 'Laracca', 'Affiliation': 'IRCAD, Research Institute Against Digestive Cancer, Strasbourg, France (Spota, Laracca, Dallemagne, Marescaux, Perretta).'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Svendrovski', 'Affiliation': 'UZIK Consulting Inc., Toronto, ON, Canada (Svendrovski).'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Fiorillo', 'Affiliation': 'From the Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy (Mascagni, Fiorillo).'}, {'ForeName': 'Sun Gyo', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'Institut Hospitalo-Universitaire (IHU), Institute of Image-Guided Surgery, Strasbourg, France (Mascagni, Pizzicannella, Fiorillo, Lim, Oudkerk Pool, Dallemagne, Swanstrom, Shlomovitz, Perretta).'}, {'ForeName': 'Marinka', 'Initials': 'M', 'LastName': 'Oudkerk Pool', 'Affiliation': 'Institut Hospitalo-Universitaire (IHU), Institute of Image-Guided Surgery, Strasbourg, France (Mascagni, Pizzicannella, Fiorillo, Lim, Oudkerk Pool, Dallemagne, Swanstrom, Shlomovitz, Perretta).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Dallemagne', 'Affiliation': 'Institut Hospitalo-Universitaire (IHU), Institute of Image-Guided Surgery, Strasbourg, France (Mascagni, Pizzicannella, Fiorillo, Lim, Oudkerk Pool, Dallemagne, Swanstrom, Shlomovitz, Perretta).'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Marescaux', 'Affiliation': 'IRCAD, Research Institute Against Digestive Cancer, Strasbourg, France (Spota, Laracca, Dallemagne, Marescaux, Perretta).'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Swanstrom', 'Affiliation': 'Institut Hospitalo-Universitaire (IHU), Institute of Image-Guided Surgery, Strasbourg, France (Mascagni, Pizzicannella, Fiorillo, Lim, Oudkerk Pool, Dallemagne, Swanstrom, Shlomovitz, Perretta).'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Shlomovitz', 'Affiliation': 'Institut Hospitalo-Universitaire (IHU), Institute of Image-Guided Surgery, Strasbourg, France (Mascagni, Pizzicannella, Fiorillo, Lim, Oudkerk Pool, Dallemagne, Swanstrom, Shlomovitz, Perretta).'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Perretta', 'Affiliation': 'Institut Hospitalo-Universitaire (IHU), Institute of Image-Guided Surgery, Strasbourg, France (Mascagni, Pizzicannella, Fiorillo, Lim, Oudkerk Pool, Dallemagne, Swanstrom, Shlomovitz, Perretta).'}]",Journal of the American College of Surgeons,['10.1097/XCS.0000000000000157']
542,35259535,Dupilumab Demonstrates Rapid Onset of Response Across Three Type 2 Inflammatory Diseases.,"BACKGROUND


Type 2 inflammatory diseases often coexist in patients. Dupilumab targets type 2 inflammation and has demonstrated treatment benefits in patients with atopic dermatitis (AD), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP) with an acceptable safety profile.
OBJECTIVE


This post hoc analysis across five phase 3 studies in patients with moderate to severe AD or asthma, or severe CRSwNP, evaluated time of onset and duration of the treatment response.
METHODS


Patients received subcutaneous dupilumab 200/300 mg or placebo. Assessments included the Eczema Area and Severity Index, Peak Pruritus Numerical Rating Scale, and Dermatology Life Quality Index in AD; pre-bronchodilator FEV 1 , daily morning peak expiratory flow, and symptom scores in asthma; and University of Pennsylvania Smell Identification Test, daily nasal congestion, and loss of smell scores in CRSwNP.
RESULTS


At week 2 after the initiation of dupilumab versus placebo, 67.8% versus 36.5% of AD patients achieved a clinically meaningful benefit (Eczema Area and Severity Index: 50% or greater improvement; Peak Pruritus Numerical Rating Scale: 3 point or greater improvement; or Dermatology Life Quality Index: 4 point or greater improvement) (P < .001). Moreover, 61.6% versus 39.9% of asthma patients achieved improvements in pre-bronchodilator FEV 1  of 100 mL or greater and 48.8% versus 26.3% achieved 200 mL or greater improvement (both P < .001); 33.2% versus 5.6% of CRSwNP patients regained a sense of smell (P < .001). Treatment effects further improved or were sustained to the end of treatment.
CONCLUSIONS


Clinically meaningful responses were achieved rapidly after the first dupilumab dose in AD, asthma, or CRSwNP and were sustained throughout treatment (see Video in this article's Online Repository at www.jaci-inpractice.org).",2022,"Assessments comprised Eczema Area and Severity Index, Peak Pruritus Numerical Rating Scale, and Dermatology Life Quality Index in AD; pre-bronchodilator FEV 1 , daily morning peak expiratory flow, and symptom scores in asthma; and University of Pennsylvania Smell Identification Test, daily nasal congestion, and loss of smell scores in CRSwNP.
","['patients', 'patients with atopic dermatitis (AD), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP']","['subcutaneous dupilumab 200/300 mg or placebo', 'dupilumab vs placebo', 'CRSwNP']","['Quality Index ≥ 4-point improvement', 'sense of smell', 'clinically meaningful benefit (Eczema Area and Severity Index ≥ 50% improvement, Peak Pruritus Numerical Rating Scale ≥ 3-point improvement, or Dermatology Life', 'Eczema Area and Severity Index, Peak Pruritus Numerical Rating Scale, and Dermatology Life Quality Index in AD; pre-bronchodilator FEV 1 , daily morning peak expiratory flow, and symptom scores in asthma; and University of Pennsylvania Smell Identification Test, daily nasal congestion, and loss of smell scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}]",,0.217586,"Assessments comprised Eczema Area and Severity Index, Peak Pruritus Numerical Rating Scale, and Dermatology Life Quality Index in AD; pre-bronchodilator FEV 1 , daily morning peak expiratory flow, and symptom scores in asthma; and University of Pennsylvania Smell Identification Test, daily nasal congestion, and loss of smell scores in CRSwNP.
","[{'ForeName': 'G Walter', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas University and Research Hospital IRCCS, Milan, Italy. Electronic address: canonica.gw@gmail.com.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'Department of Respiratory Diseases, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Anju T', 'Initials': 'AT', 'LastName': 'Peters', 'Affiliation': 'Allergy-Immunology Division and the Sinus and Allergy Center, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Desrosiers', 'Affiliation': ""Centre de recherche du Centre hospitalier de l'Université de Montréal, Montreal, Québec, Canada.""}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bachert', 'Affiliation': 'Upper Airways Research Laboratory, Department of Otorhinolaryngology, Ghent University, Ghent, Belgium; CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Weidinger', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Schleswig-Holstein, Germany.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Ore.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Sanofi, Cambridge, Mass.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Siddhesh', 'Initials': 'S', 'LastName': 'Kamat', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Asif H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Laws', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi, Cambridge, Mass.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Leda P', 'Initials': 'LP', 'LastName': 'Mannent', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ortiz', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Yamo', 'Initials': 'Y', 'LastName': 'Deniz', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Djandji', 'Affiliation': 'Sanofi, Cambridge, Mass.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2022.02.026']
543,35259534,As-Needed Use of Short-Acting β 2 -Agonists Alone Versus As-Needed Use of Short-Acting β 2 -Agonists Plus Inhaled Corticosteroids in Pediatric Patients With Mild Intermittent (Step 1) Asthma: A Cost-Effectiveness Analysis.,"BACKGROUND


Although the efficacy of the as-needed use of short-acting β 2 -agonists (SABAs) plus inhaled corticosteroids (ICS) for treating children with mild intermittent asthma has been demonstrated, evidence of its cost-effectiveness is scarce.
OBJECTIVES


The aim of the present study was to compare the cost-effectiveness of the as-needed use of SABAs alone versus the as-needed use of SABAs plus ICS in children 5 to 11 years old with mild intermittent (step 1) asthma but suffering from an exacerbation of asthma symptoms.
METHODS


A decision-analysis model was adapted. Effectiveness parameters were obtained from a randomized clinical trial. Cost data were obtained from hospital bills and from the national manual of drug prices in Colombia. The study was carried out from the perspective of the national health care system in Colombia. The main outcome of the model was a first course of prednisone for an asthma exacerbation (AE).
RESULTS


Compared with the use of SABAs alone, the as-needed use of SABAs plus ICS was associated with lower overall treatment costs (US$17.99 vs US$27.94 mean cost per patient) and a higher probability of a lack of a requirement for a first course of prednisone (0.6500 vs 0.5100), thus showing dominance.
CONCLUSIONS


In Colombia, compared with the use of albuterol alone, the use of beclomethasone dipropionate added to albuterol as needed for symptom relief is cost-effective in children 5 to 11 years old with mild intermittent (step 1) asthma, because it involves a higher probability of a lack of a requirement for prednisone for AE at lower total treatment costs.",2022,"Compared to the use of SABAs alone, the as-needed use of SABAs plus ICS was associated with lower overall treatment costs (US$17.99 vs. US$27.94 mean cost per patient) and a higher probability of a lack of a requirement for a first course of prednisone (0.6500 vs. 0.5100), thus showing dominance.
","['pediatric patients with mild intermittent (step-1) asthma', 'children with mild intermittent asthma', 'children 5-11 years old with mild intermittent (step-1) asthma', 'children 5-11 years old with mild intermittent (step-1) asthma but suffering from an exacerbation of asthma symptoms']","['SABAs plus ICS', 'prednisone', 'SABAs alone', 'short-acting β2-agonist (SABAs) plus inhaled corticosteroids (ICS', 'beclomethasone dipropionate']","['asthma exacerbation (AE', 'cost-effectiveness']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1301776', 'cui_str': 'Step 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1960045', 'cui_str': 'Mild intermittent asthma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004906', 'cui_str': 'Beclomethasone dipropionate'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0623866,"Compared to the use of SABAs alone, the as-needed use of SABAs plus ICS was associated with lower overall treatment costs (US$17.99 vs. US$27.94 mean cost per patient) and a higher probability of a lack of a requirement for a first course of prednisone (0.6500 vs. 0.5100), thus showing dominance.
","[{'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Rodríguez-Martínez', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Nacional de Colombia, Bogota, Colombia; Department of Pediatric Pulmonology, School of Medicine, Universidad El Bosque, Bogota, Colombia. Electronic address: carerodriguezmar@unal.edu.co.'}, {'ForeName': 'Monica P', 'Initials': 'MP', 'LastName': 'Sossa-Briceño', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Universidad Nacional de Colombia, Bogota, Colombia.'}, {'ForeName': 'Jefferson Antonio', 'Initials': 'JA', 'LastName': 'Buendia', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Medicine, Research Group in Pharmacology and Toxicology (INFARTO), Universidad de Antioquia, Medellín, Colombia.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2022.02.022']
544,35272102,The effects of hip- and ankle-focused exercise intervention on lower limb mechanics during single leg squat among physically active females.,"OBJECTIVES


There are two types of kinetic chain in dynamic knee valgus (DKV) namely top-down (proximal origins) and bottom-up (distal origins). This study compared the influence of four-week hip- and ankle-focused exercises on lower limb mechanics during single-leg squat (SLS) among physically active females.
METHODS


Thirty-six physically active females with excessive DKV were divided into either HIP, ANKLE, or control groups. The intervention groups completed exercises that focused either on the hip or ankle musculature for 12 sessions over four weeks. The SLS test protocol was performed with 3D motion capture at pre- and post-intervention. Data were analyzed with two-way ANOVA test.
RESULTS


HIP group showed increased dominant knee (F (2.66) = 9.437, P = .001) and ankle (F(2.66) = 16.465, P = .001) sagittal moment during 45° SLS at post-intervention compared to ANKLE and Control groups. HIP group also showed increased hip flexion angle for dominant (F(2.66) = 12.032, P = .001) and non-dominant leg (F(2.66) = 3.618, P = .032) compared to other groups during 60° SLS. No other significant differences were observed on other variables.
CONCLUSION


DKV did not show any significant changes during SLS after a four-week exercise intervention focusing on hip and ankle joints.",2022,DKV did not show any significant changes during SLS after a four-week exercise intervention focusing on hip and ankle joints.,"['lower limb mechanics during single leg squat among physically active females', 'physically active females', 'Thirty-six physically active females with excessive DKV']","['hip- and ankle-focused exercise intervention', 'four-week hip- and ankle-focused exercises', 'single-leg squat (SLS', 'exercises that focused either on the hip or ankle musculature']","['dominant knee', 'hip flexion angle']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",36.0,0.015809,DKV did not show any significant changes during SLS after a four-week exercise intervention focusing on hip and ankle joints.,"[{'ForeName': 'Farhah Nadhirah Aiman', 'Initials': 'FNA', 'LastName': 'Sahabuddin', 'Affiliation': 'Exercise & Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia. Electronic address: farhahsahabuddin96@gmail.com.'}, {'ForeName': 'Nazatul Izzati', 'Initials': 'NI', 'LastName': 'Jamaludin', 'Affiliation': 'Exercise & Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia. Electronic address: nazatulizzati096@gmail.com.'}, {'ForeName': 'Nurul Azuar', 'Initials': 'NA', 'LastName': 'Hamzah', 'Affiliation': 'Exercise & Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia. Electronic address: nazuar@usm.my.'}, {'ForeName': 'Chuen Leang', 'Initials': 'CL', 'LastName': 'Chok', 'Affiliation': 'Centre of Sports Biomechanics, National Sports Institute of Malaysia, Kuala Lumpur, Malaysia. Electronic address: ccleang@isn.gov.my.'}, {'ForeName': 'Shazlin', 'Initials': 'S', 'LastName': 'Shaharudin', 'Affiliation': 'Exercise & Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia. Electronic address: shazlin@usm.my.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2022.03.001']
545,35275761,D-dimer in Marfan syndrome: effect of obstructive sleep apnea induced blood pressure surges.,"Aortic dissection and rupture are the major causes of premature death in persons with Marfan syndrome (MFS), a rare genetic disorder featuring cardiovascular, skeletal, and ocular impairments. We and others have found that obstructive sleep apnea (OSA) confers significant vascular stress in this population and may accelerate aortic disease progression. We hypothesized that D-dimer, a diagnostic biomarker for several types of vascular injury that is also elevated in persons with MFS with aortic enlargement, may be sensitive to cardiovascular stresses caused by OSA. To test this concept, we recruited 16 persons with MFS without aortic dissection and randomized them to two nights of polysomnography, without (baseline) and with OSA treatment: continuous positive airway pressure (CPAP). In addition to scoring OSA by the apnea-hypopnea index (AHI), beat-by-beat systolic BP (SBP) and pulse-pressure (PP) fluctuations were quantified. Morning blood samples were also assayed for D-dimer levels. In this cohort (male:female, 10:6; age, 36 ± 13 yr; aortic diameter, 4 ± 1 cm), CPAP eliminated OSA (AHI: 20 ± 17 vs. 3 ± 2 events/h,  P  = 0.001) and decreased fluctuations in SBP (13 ± 4 vs. 9 ± 3 mmHg,  P  = 0.011) and PP (7 ± 2 vs. 5 ± 2 mmHg,  P  = 0.013). CPAP also reduced D-dimer levels from 1,108 ± 656 to 882 ± 532 ng/mL ( P  = 0.023). Linear regression revealed a positive association between the maximum PP during OSA and D-dimer in both the unadjusted ( r  = 0.523,  P  = 0.038) and a model adjusted for contemporaneous aortic root diameter ( r  = 0.733,  P  = 0.028). Our study revealed that overnight CPAP reduces D-dimer levels commensurate with the elimination of OSA and concomitant hemodynamic fluctuations. Morning D-dimer measurements together with OSA screening might serve as predictors of vascular injury in MFS. NEW & NOTEWORTHY  What is New? Surges in blood pressure caused by obstructive sleep apnea during sleep increase vascular stress and D-dimer levels in Marfan syndrome. Elevations in D-dimer can be lowered with CPAP. What is Noteworthy? D-dimer levels might serve as a marker for determining the significance of obstructive sleep apnea in persons with Marfan syndrome. D-dimer or obstructive sleep apnea screening is a potential method to identify persons with Marfan syndrome at risk for adverse cardiovascular events.",2022,CPAP also reduced D-dimer levels from 1108±656 to 882±532ng/ml (p=0.023).,"['MFS persons with aortic enlargement', '16 MFS persons without aortic dissection and randomized them to two nights of polysomnography, without (baseline) and with', 'persons with Marfan Syndrome (MFS', 'Marfan Syndrome']",['OSA treatment: continuous positive airway pressure (CPAP'],"['CPAP eliminated OSA', 'CPAP also reduced D-dimer levels', 'fluctuations in SBP', 'apnea-hypopnea-index (AHI), beat-by-beat systolic-BP (SBP) and pulse-pressure (PP) fluctuations', 'Morning blood samples', 'Blood Pressure Surges']","[{'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0340643', 'cui_str': 'Dissection of aorta'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",16.0,0.0374995,CPAP also reduced D-dimer levels from 1108±656 to 882±532ng/ml (p=0.023).,"[{'ForeName': 'Mudiaga', 'Initials': 'M', 'LastName': 'Sowho', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schneider', 'Affiliation': 'American Sleep Clinic, Center for Sleep Medicine, Frankfurt, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jun', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'MacCarrick', 'Affiliation': 'McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Schwartz', 'Affiliation': 'Department of Otolaryngology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Luu', 'Initials': 'L', 'LastName': 'Pham', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Sgambati', 'Affiliation': 'Center for Interdisciplinary Sleep Research and Education, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Lima', 'Affiliation': 'Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Vsevolod', 'Initials': 'V', 'LastName': 'Polotsky', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Enid', 'Initials': 'E', 'LastName': 'Neptune', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00004.2022']
546,35217193,The positive impact of 12 weeks of dance and balance training on the circulating amyloid precursor protein and serotonin concentration as well as physical and cognitive abilities in elderly women.,"BACKGROUND


The study aimed to compare the effectiveness of 12-weeks dance training with balance training on fall risk, physical and cognitive functions. The study's second aim was to evaluate the association between physical and cognitive functions with circulating markers of neurodegeneration and cognitive impairments in elders.
MATERIALS AND METHODS


30 older women (aged 73.3 ± 4.5) were randomly assigned into three groups: balance training (BG), dance training (DG) and control group (CG). To assess the study aims Time up and go test (TUG), 6 minute walk test (6MWT), determination test (DT), blood amyloid precursor protein (APP) and serotonin concentration were performed.
RESULTS


The results showed an improvement in 6MWT (p = 0.0001 for DG and BD), walking speed (p = 0.0001 for DG and BG) and TUG, only for DG (p = 0.0013). The number of correct responses in DT increased in both groups (p = 0.014 and p = 0.005, for DG and BG, respectively). In DG the increase in the total number of reactions was observed (p = 0.013). The improvement in cognitive and physical functions was associated with an increase in APP (p = 0.036 and p = 0.014) and a decrease in serotonin concentrations (p = 0.042 and p = 0.049), respectively in DG and BG.
CONCLUSION


Dance training intervention could have more benefits on elders' physical and cognitive functions. However, both trainings may be important factors modifying the concentration of circulating proteins associated with neurodegenerative and cognitive disorders.",2022,"The results showed an improvement in 6MWT (p = 0.0001 for DG and BD), walking speed (p = 0.0001 for DG and BG) and TUG, only for DG (p = 0.0013).","['elders', '30 older women (aged 73.3\u202f±\u202f4.5', 'elderly women']","['dance and balance training', 'balance training (BG), dance training (DG) and control group (CG', '12-weeks dance training with balance training', 'Dance training intervention']","['number of correct responses in DT', '6MWT', 'APP', 'total number of reactions', ""elders' physical and cognitive functions"", 'fall risk, physical and cognitive functions', 'walking speed', 'Time up and go test (TUG), 6\u202fminute walk test (6MWT), determination test (DT), blood amyloid precursor protein (APP) and serotonin concentration', 'serotonin concentrations', 'cognitive and physical functions']","[{'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0085151', 'cui_str': 'Amyloid beta Precursor Protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",30.0,0.0104197,"The results showed an improvement in 6MWT (p = 0.0001 for DG and BD), walking speed (p = 0.0001 for DG and BG) and TUG, only for DG (p = 0.0013).","[{'ForeName': 'Ewa Aleksandra', 'Initials': 'EA', 'LastName': 'Rodziewicz-Flis', 'Affiliation': 'Department of Basic Physiotherapy, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: ewa.rodziewicz@awf.gda.pl.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Kawa', 'Affiliation': 'Department of Basic Physiotherapy, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: malgorzata.kawa@awf.gda.pl.'}, {'ForeName': 'Wojciech Romuald', 'Initials': 'WR', 'LastName': 'Skrobot', 'Affiliation': 'Department of Clinical Physiotherapy, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: wojciech.skrobot@awf.gda.pl.'}, {'ForeName': 'Damian Józef', 'Initials': 'DJ', 'LastName': 'Flis', 'Affiliation': 'Department of Pharmaceutical Pathophysiology, Medical University of Gdansk, Debinki 1 Street, 80-211 Gdansk, Poland. Electronic address: damian.flis@gumed.edu.pl.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Wilczyńska', 'Affiliation': 'Department of Psychology, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: dominika.wilczynska@awf.gda.pl.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Szaro-Truchan', 'Affiliation': 'Department of Basic Physiotherapy, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: marzena.szaro-truchan@awf.gda.pl.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Bolek-Adamek', 'Affiliation': 'Department of Fitness, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: justyna.bolek@awf.gda.pl.'}, {'ForeName': 'Jan Jacek', 'Initials': 'JJ', 'LastName': 'Kaczor', 'Affiliation': 'Department of Animal and Human Physiology, University of Gdansk, J Bazynskiego 8 Street, 80-308 Gdansk, Poland. Electronic address: jan.kaczor@ug.edu.pl.'}]",Experimental gerontology,['10.1016/j.exger.2022.111746']
547,35245224,Continuous Titration of Inspired Oxygen Using Oxygen Reserve Index to Decrease Oxygen Exposure During One-Lung Ventilation: A Randomized Controlled Trial.,"BACKGROUND


A high fraction of inspired oxygen (Fio2) is administered during one-lung ventilation (OLV). However, a high Fio2 is not physiologic and may lead to various complications. We hypothesized that continuous titration of Fio2 using the oxygen reserve index (ORI) reduces oxygen exposure compared to conventional management during OLV.
METHODS


In this randomized, double-blinded trial, patients undergoing thoracic surgery were assigned to an ORI (n = 64) or a control group (n = 60). In the ORI group, ORI was continuously displayed using multiwavelength pulse co-oximetry (Masimo) between 0 and 1 (0, no reserve; 1, maximum reserve), and Fio2 was titrated for a target ORI of 0.21 at 5-minute intervals during OLV. In the control group, Fio2 was adjusted using arterial blood gas analysis measured at 15 minutes after OLV initiation. The primary end point was the time-weighted average Fio2 during OLV.
RESULTS


Overall, time-weighted average Fio2 did not differ between the groups (control versus ORI: median [interquartile range], 0.87 [0.73-1.00] vs 0.82 [0.68-0.93]; P = .09). However, in a subgroup analysis, the ORI group reduced time-weighted average Fio2 after pulmonary vascular ligation compared to the control group (control versus ORI: median [interquartile range], 0.75 [0.70-1.00] vs 0.72 [0.59-0.89]; P = .0261). The incidence of intraoperative hypoxia (arterial oxygen saturation [Spo2] <94%; control versus ORI: 32% [19/60; 95% confidence interval (CI), 20-45] vs 19% [12/64; 95% CI, 10-31]; P = .09), and postoperative complications within the first 7 days did not differ between the groups.
CONCLUSIONS


ORI-guided continuous Fio2 titration does not reduce overall oxygen exposure during OLV.",2022,"The incidence of intraoperative hypoxia (arterial oxygen saturation [Spo2] <94%; control versus ORI: 32% [19/60; 95% confidence interval (CI), 20-45] vs 19% [12/64; 95% CI, 10-31]; P = .09), and postoperative complications within the first 7 days did not differ between the groups.
","['During One-Lung Ventilation', 'patients undergoing thoracic surgery']","['ORI', 'Continuous Titration of Inspired Oxygen Using Oxygen Reserve Index to Decrease Oxygen Exposure']","['overall oxygen exposure', 'Overall, time-weighted average Fio2', 'time-weighted average Fio2 after pulmonary vascular ligation', 'postoperative complications', 'ORI', 'time-weighted average Fio2 during OLV', 'incidence of intraoperative hypoxia (arterial oxygen saturation [Spo2']","[{'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}]",,0.568934,"The incidence of intraoperative hypoxia (arterial oxygen saturation [Spo2] <94%; control versus ORI: 32% [19/60; 95% confidence interval (CI), 20-45] vs 19% [12/64; 95% CI, 10-31]; P = .09), and postoperative complications within the first 7 days did not differ between the groups.
","[{'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Jie Ae', 'Initials': 'JA', 'LastName': 'Kim', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Hyun Joo', 'Initials': 'HJ', 'LastName': 'Ahn', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Young Soo', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'MiHye', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Heejoon', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Keoungah', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Dentistry, Dankook University, Cheon-an, South Korea.'}, {'ForeName': 'Nam Young', 'Initials': 'NY', 'LastName': 'Lee', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005967']
548,35247729,Neurofeedback-guided kinesthetic motor imagery training in Parkinson's disease: Randomized trial.,"BACKGROUND


Parkinson's disease (PD) causes difficulty with maintaining the speed, size, and vigor of movements, especially when they are internally generated. We previously proposed that the insula is important in motivating intentional movement via its connections with the dorsomedial frontal cortex (dmFC). We demonstrated that subjects with PD can increase the right insula-dmFC functional connectivity using fMRI-based neurofeedback (NF) combined with kinesthetic motor imagery (MI). The current study is a randomized clinical trial testing whether NF-guided kinesthetic MI training can improve motor performance and increase task-based and resting-state right insula-dmFC functional connectivity in subjects with PD.
METHODS


We assigned nondemented subjects with mild PD (Hoehn & Yahr stage ≤ 3) to the experimental kinesthetic MI with NF (MI-NF, n = 22) and active control visual imagery (VI, n = 22) groups. Only the MI-NF group received NF-guided MI training (10-12 runs). The NF signal was based on the right insula-dmFC functional connectivity strength. All subjects also practiced their respective imagery tasks at home daily for 4 weeks. Post-training changes in 1) task-based and resting-state right insula-dmFC functional connectivity were the primary imaging outcomes, and 2) MDS-UPDRS motor exam and motor function scores were the primary and secondary clinical outcomes, respectively.
RESULTS


The MI-NF group was not significantly different from the VI group in any of the primary imaging or clinical outcome measures. The MI-NF group reported subjective improvement in kinesthetic body awareness. There was significant and comparable improvement only in motor function scores in both groups (secondary clinical outcome). This improvement correlated with NF regulation of the right insula-dmFC functional connectivity only in the MI-NF group. Both groups showed specific training effects in whole-brain functional connectivity with distinct neural circuits supporting kinesthetic motor and visual imagery (exploratory imaging outcome).
CONCLUSIONS


The functional connectivity-based NF regulation was unsuccessful, however, both kinesthetic MI and VI practice improved motor function in our cohort with mild PD.",2022,"Both groups showed specific training effects in whole-brain functional connectivity with distinct neural circuits supporting kinesthetic motor and visual imagery (exploratory imaging outcome).
","['subjects with PD', ""Parkinson's disease"", 'nondemented subjects with mild PD (Hoehn & Yahr stage\xa0≤\xa03) to the']","['NF-guided MI training', 'NF-guided kinesthetic MI training', 'experimental kinesthetic MI with NF (MI-NF, n\xa0=\xa022) and active control visual imagery', 'fMRI-based neurofeedback (NF) combined with kinesthetic motor imagery (MI', 'Neurofeedback-guided kinesthetic motor imagery training']","['NF regulation of the right insula-dmFC functional connectivity', 'MDS-UPDRS motor exam and motor function scores', 'motor function scores', 'motor performance and increase task-based and resting-state right insula-dmFC functional connectivity', 'kinesthetic body awareness', 'right insula-dmFC functional connectivity']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",22.0,0.113779,"Both groups showed specific training effects in whole-brain functional connectivity with distinct neural circuits supporting kinesthetic motor and visual imagery (exploratory imaging outcome).
","[{'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Tinaz', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA. Electronic address: sule.tinaz@yale.edu.'}, {'ForeName': 'Serageldin', 'Initials': 'S', 'LastName': 'Kamel', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA.'}, {'ForeName': 'Sai S', 'Initials': 'SS', 'LastName': 'Aravala', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elfil', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Bayoumi', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Scheinost', 'Affiliation': 'Yale School of Medicine, Department of Radiology and Biomedical Imaging, 300 Cedar St, New Haven, CT 06519, USA; Yale University, Department of Biomedical Engineering, 17 Hillhouse Avenue, New Haven, CT 06520, USA; Yale School of Medicine, Child Study Center, 230 South Frontage Road, New Haven, CT 06519, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Yale School of Medicine, Yale Stress Center, 2 Church St South, Suite 209, New Haven, CT 06519, USA; Yale School of Medicine, Department of Psychiatry, 300 George St, New Haven, CT 06511, USA; Yale School of Medicine, Department of Neuroscience, 333 Cedar St, SHM-L-200, New Haven, CT 06510, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hampson', 'Affiliation': 'Yale School of Medicine, Department of Radiology and Biomedical Imaging, 300 Cedar St, New Haven, CT 06519, USA; Yale University, Department of Biomedical Engineering, 17 Hillhouse Avenue, New Haven, CT 06520, USA; Yale School of Medicine, Child Study Center, 230 South Frontage Road, New Haven, CT 06519, USA; Yale School of Medicine, Department of Psychiatry, 300 George St, New Haven, CT 06511, USA.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2022.102980']
549,35257600,Incorporating estimands into clinical trial statistical analysis plans.,"BACKGROUND


International Council for Harmonisation (ICH) E9  Statistical Principles for Clinical Trials  was developed as a consensus guidance document to encourage worldwide harmonization of the principles of statistical methodology in clinical trials. Addendum E9 (R1) clarified and extended ICH E9 with a focus on estimands and sensitivity analyses. Since the release of E9 (R1), clinical trial protocols have included estimands, but there is variation in how they are presented. Statistical analysis plans (SAPs) are increasingly becoming publicly available (e.g. posting on ClinicalTrials.gov) and present an opportunity to link estimands with planned analyses to present the alignment of trial objectives, design, conduct, and analysis.
METHODS


A table format was used to create a template for inclusion in SAPs that satisfies ICH E9 (R1) guidance to align statistical analysis to the estimand. The template provides a consistent structure for presentation of estimands and the associated analysis, and is applicable to a wide range of trial designs. We illustrate use of the template with a hypothetical clinical trial in HIV-1.
RESULTS


The estimand-to-analysis table template starts with the study objective describing the clinical question of interest as written in the trial protocol. The remainder of the table describes each attribute of the estimand (treatment, target population, variable, intercurrent events, and population-level summary) in the left column (ESTIMAND), while the right column describes how each attribute will be handled using the data collected in the clinical trial (ANALYSIS). The template was applied to a hypothetical, early-phase single-arm trial, modeled after a pediatric trial in HIV, where the objective was to determine the safety of a new antiretroviral drug as part of a combination antiretroviral treatment regimen in the pediatric population. Three intercurrent events were illustrated in the table: death, premature treatment discontinuation before 24 weeks, and pregnancy. An estimand-to-analysis table from a grant application that addresses the primary objective of a placebo-controlled randomized trial is also presented to demonstrate an alternative usage.
CONCLUSION


We found the template to be useful in study design, providing a snapshot of the objective, target population, potential intercurrent events, analysis plan, and considerations for missing data in one place and facilitating discussion among stakeholders. The proposed standardized presentation of estimand attributes and analysis considerations in SAPs will provide guidance to SAP authors and consistency across studies to facilitate reviews.",2022,"The template provides a consistent structure for presentation of estimands and the associated analysis, and is applicable to a wide range of trial designs.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.4425,"The template provides a consistent structure for presentation of estimands and the associated analysis, and is applicable to a wide range of trial designs.","[{'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Kendall', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Smeaton', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Lindsey', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/17407745221080463']
550,35261115,The causal role of the bilateral ventrolateral prefrontal cortices on emotion regulation of social feedback.,"The ventrolateral prefrontal cortices (VLPFC) are crucial regions involved in voluntary emotion regulation. However, the lateralization of the VLPFC in downregulating negative emotions remains unclear; and whether the causal role of the VLPFC is generalizable to upregulating positive emotions is unexplored. This study used transcranial magnetic stimulation (TMS) to examine the causal relationship between the left/right VLPFC and social emotion reappraisal. One hundred and twenty participants were randomly assigned to either active (left and right VLPFC groups, n = 40/40) or sham (vertex, n = 40) TMS groups. Participants were instructed to passively receive social feedback or use reappraisal strategies to positively regulate their emotions. While the subjective emotional rating showed that the bilateral VLPFC facilitated the reappraisal success, the electrophysiological measure of the late positive potential (LPP) demonstrated a more critical role of the right VLPFC on social pain relief (decreased LPP amplitudes) and social reward magnification (enhanced LPP amplitudes). In addition, the influence of emotion regulation on social evaluation was found to be mediated by the memory of social feedback, indicating the importance of memory in social behavioral shaping. These findings suggest clinical protocols for the rehabilitation of emotion-regulatory function in patients with affective and social disorders.",2022,"While the subjective emotional rating showed that the bilateral VLPFC facilitated the reappraisal success, the electrophysiological measure of the late positive potential (LPP) demonstrated a more critical role of the right VLPFC on social pain relief (decreased LPP amplitudes) and social reward magnification (enhanced LPP amplitudes).","['One hundred and twenty participants', 'patients with affective and social disorders']","['transcranial magnetic stimulation (TMS', 'social feedback or use reappraisal strategies to positively regulate their emotions', 'TMS', 'active (left and right VLPFC groups, n\xa0=\xa040/40) or sham (vertex, n\xa0=\xa040']","['subjective emotional rating', 'social pain relief (decreased LPP amplitudes) and social reward magnification (enhanced LPP amplitudes', 'emotion regulation of social feedback']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",120.0,0.0189354,"While the subjective emotional rating showed that the bilateral VLPFC facilitated the reappraisal success, the electrophysiological measure of the late positive potential (LPP) demonstrated a more critical role of the right VLPFC on social pain relief (decreased LPP amplitudes) and social reward magnification (enhanced LPP amplitudes).","[{'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Institute of Brain and Psychological Sciences, Sichuan Normal University, Chengdu, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Zixin', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Weimao', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Shenzhen Yingchi Technology Co., Ltd, Shenzhen, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Institute of Brain and Psychological Sciences, Sichuan Normal University, Chengdu, China.'}]",Human brain mapping,['10.1002/hbm.25824']
551,34865071,"Impact of Dapivirine and Placebo Vaginal Rings on the Microbiota of Adolescent, Lactating, and Postmenopausal Females.","BACKGROUND


A 25-mg dapivirine vaginal ring has been demonstrated to reduce risk of human immunodeficiency virus (HIV) acquisition in nonpregnant adult women. In this secondary analysis of studies conducted in US adolescent, lactating, and postmenopausal females, vaginal microbiota was assessed prior to and after ring use, and between dapivirine and placebo ring users.
METHODS


Vaginal fluid swabs were collected before and after product use for the evaluation of microbiota using Nugent criteria, quantitative culture, and quantitative polymerase chain reaction.
RESULTS


Vaginal ring use did not impact bacterial vaginosis prevalence among the 3 populations and was associated with minimal shifts in microbiota. Adolescents in both arms demonstrated an increased prevalence of Lactobacillus crispatus and a decrease in quantity of Megasphaera lornae. Postmenopausal active and placebo ring users demonstrated an increased prevalence of lactobacilli and non-albicans yeast, while dapivirine ring users demonstrated an increased prevalence of Candida albicans and increased quantity of group B Streptococcus and non-albicans yeasts. Prevotella species were increased in lactating women, whereas Prevotella timonensis increased in prevalence and concentration among adolescent and postmenopausal females and Prevotella bivia increased in prevalence among adolescent dapivirine ring users.
CONCLUSIONS


Dapivirine vaginal ring use was associated with minimal changes in the vaginal microbiota that are likely not clinically significant.",2022,"Postmenopausal active and placebo ring users demonstrated an increased prevalence of lactobacilli and non-albicans yeast while dapivirine ring users demonstrated an increased prevalence of Candida albicans, and increased quantity of Group B Streptococcus (GBS) and non-albicans yeasts.","['nonpregnant adult women', 'Adolescent, Lactating, and Postmenopausal Females']","['Dapivirine and Placebo Vaginal Rings', 'dapivirine vaginal ring']","['bacterial vaginosis prevalence', 'risk of HIV acquisition', 'quantity of Megasphaera lornae', 'prevalence of Lactobacillus crispatus', 'prevalence of Candida albicans', 'prevalence of lactobacilli and non-albicans yeast']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C1434916', 'cui_str': 'dapivirine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0317723', 'cui_str': 'Megasphaera'}, {'cui': 'C0317614', 'cui_str': 'Lactobacillus crispatus'}, {'cui': 'C0006837', 'cui_str': 'Candida albicans'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}]",,0.118122,"Postmenopausal active and placebo ring users demonstrated an increased prevalence of lactobacilli and non-albicans yeast while dapivirine ring users demonstrated an increased prevalence of Candida albicans, and increased quantity of Group B Streptococcus (GBS) and non-albicans yeasts.","[{'ForeName': 'Michele N', 'Initials': 'MN', 'LastName': 'Austin', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Meyn', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Avolia', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Melinda A', 'Initials': 'MA', 'LastName': 'Petrina', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cosentino', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Calins', 'Initials': 'C', 'LastName': 'Alphonse', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Beatrice A', 'Initials': 'BA', 'LastName': 'Chen', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bunge', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Noguchi', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beigi', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Squires', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiab590']
552,35258802,Response to intervention for high school students: examining baseline word reading skills and reading comprehension outcomes.,"The purpose of this post hoc analysis was to analyze if pre-intervention word reading skills contributed to intervention response on reading comprehension outcomes. High school students with reading difficulties were randomized to a business as usual (BaU) or treatment condition that provided 2 years of an intensive, multicomponent word reading and reading comprehension intervention. Participants were assessed on measures of word reading and reading comprehension for pretest and reading comprehension only for posttest. Findings revealed no statistically significant differences with word-level fluency modeled as a continuous variable between treatment and control on reading comprehension. Regardless of assignment to condition, higher word-level fluency scores predicted higher posttest outcomes on years 1 and 2 reading comprehension scores.",2022,Findings revealed no statistically significant differences with word-level fluency modeled as a continuous variable between treatment and control on reading comprehension.,"['High school students with reading difficulties', 'high school students']","['business as usual (BaU) or treatment condition that provided 2\xa0years of an intensive, multicomponent word reading and reading comprehension intervention']","['reading comprehension', 'word reading and reading comprehension for pretest and reading comprehension', 'word-level fluency']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0586742', 'cui_str': 'Difficulty reading'}]","[{'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0416437,Findings revealed no statistically significant differences with word-level fluency modeled as a continuous variable between treatment and control on reading comprehension.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Solis', 'Affiliation': 'Graduate School of Education, University of California Riverside, 1207 Sproul Hall, Riverside, CA, 92521, USA. msolis@ucr.edu.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Kulesz', 'Affiliation': 'Texas Institute for Measurement Evaluation and Statistics, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'School of Education, Indiana University, Bloomington, IA, USA.'}]",Annals of dyslexia,['10.1007/s11881-022-00253-5']
553,35259918,Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA.,"BACKGROUND


ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary disease and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality-of-life (QOL) substudy.
METHODS


In 1819 participants (907 INV, 912 conservative strategy), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months postrandomization; and at study closeout. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index).
RESULTS


Median age was 67 years, 19.2% were female, and 15.9% were non-White. The estimated mean difference for the 19-item Seattle Angina Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2-2.5] over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency score >80). Among patients with more frequent angina at baseline (SAQ Angina Frequency score <80, 744 patients, 41%), those randomly assigned to INV had a mean 3.7-point higher 19-item Seattle Angina Questionnaire Summary score than conservative strategy (95% CI, 1.6-5.8) with consistent effects across SAQ subscales: Physical Limitations 3.2 points (95% CI, 0.2-6.1), Angina Frequency 3.2 points (95% CI, 1.2-5.1), Quality of Life/Health Perceptions 5.3 points (95% CI, 2.8-7.8). For the Duke Activity Status Index, no difference was estimated overall by treatment, but in patients with baseline SAQ Angina Frequency scores <80, Duke Activity Status Index scores were higher for INV (3.2 points [95% CI, 0.6-5.7]), whereas patients with rare/absent baseline angina showed no treatment-related differences. Moderate to severe depression was infrequent at randomization (11.5%-12.8%) and was unaffected by treatment assignment.
CONCLUSIONS


In the ISCHEMIA comprehensive QOL substudy, patients with more frequent baseline angina reported greater improvements in the symptom, physical functioning, and psychological well-being dimensions of QOL when treated with an invasive strategy, whereas patients who had rare/absent angina at baseline reported no consistent treatment-related QOL differences.
REGISTRATION


URL: https://www.
CLINICALTRIALS


gov; Unique identifier: NCT01471522.",2022,"The estimated mean difference for the SAQ-19 Summary score favored INV (1.4 points, 95% confidence interval [CI] 0.2, 2.5 over all follow-up).","['1,819 participants (907 INV, 912 CON', 'Chronic Coronary Disease in ISCHEMIA', 'Median age was 67 years, 19.2% were female, and 15.9% were non-white', '5,179 participants with chronic coronary disease (CCD) and moderate or severe ischemia']","['initial invasive treatment strategy (INV) with an initial conservative strategy (CON', 'Medical and Invasive Approaches (ISCHEMIA']","['Moderate to severe depression', 'Quality of Life/Health Perceptions', 'SAQ-19 Summary score', 'Comprehensive Quality of Life Outcomes', 'DASI scores', 'angina-related QOL (19-item Seattle Angina Questionnaire [SAQ-19]), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index', 'symptom, physical functioning, and psychological well-being dimensions of QOL']","[{'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0050133', 'cui_str': '9,10-anthraquinone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4720913', 'cui_str': 'Duke activity status index'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",5179.0,0.235681,"The estimated mean difference for the SAQ-19 Summary score favored INV (1.4 points, 95% confidence interval [CI] 0.2, 2.5 over all follow-up).","[{'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., R.B., S.A., M.R.D., K.J.A., K.N.B., D.C., K.P.A.).'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Saint Luke's Mid America Heart Institute/University of Missouri, Kansas City (J.A.S.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bigelow', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., R.B., S.A., M.R.D., K.J.A., K.N.B., D.C., K.P.A.).'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., R.B., S.A., M.R.D., K.J.A., K.N.B., D.C., K.P.A.).'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Daniels', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., R.B., S.A., M.R.D., K.J.A., K.N.B., D.C., K.P.A.).'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., R.B., S.A., M.R.D., K.J.A., K.N.B., D.C., K.P.A.).'}, {'ForeName': 'Khaula N', 'Initials': 'KN', 'LastName': 'Baloch', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., R.B., S.A., M.R.D., K.J.A., K.N.B., D.C., K.P.A.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'Cardiovascular Research Foundation, New York (D.J.C.).'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Sweden (C.H.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St. Michael's Hospital, University of Toronto, and Canadian Heart Research Centre, Ontario, Canada (S.G.G.).""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': 'NYU Grossman School of Medicine, New York (S.B., H.R.R., J.S.H.).'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Cyr', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., R.B., S.A., M.R.D., K.J.A., K.N.B., D.C., K.P.A.).'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'NYU Grossman School of Medicine, New York (S.B., H.R.R., J.S.H.).'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., R.B., S.A., M.R.D., K.J.A., K.N.B., D.C., K.P.A.).'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.W.S.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, CA (D.J.M.).'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'NYU Grossman School of Medicine, New York (S.B., H.R.R., J.S.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.121.057363']
554,35262226,Does group size matter during collaborative skills learning? A randomised study.,"BACKGROUND


Collaborative skills learning in the form of dyad learning compared with individual learning has been shown to lead to non-inferior skills retention and transfer. However, we have limited knowledge on which learning activities improve collaborative skills training and how the number of collaborators may impact skills transfer. We explored the effects of skills training individually, in dyads, triads or tetrads on learning activities during training and on subsequent skills transfer.
METHODS


In a randomised, controlled study, participants completed a pre-post-transfer-test set-up in groups of one to four. Participants completed 2 hours of obstetric ultrasound training. In the dyad, triad and tetrad group participants took turns actively handling the ultrasound probe. All performances were rated by two blinded experts using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale and a Global Rating Scale (GRS). All training was video recorded, and learning activities were analysed using the Interactive-Constructive-Active-Passive (ICAP) framework.
RESULTS


One hundred one participants completed the simulation-based training, and ninety-seven completed the transfer test. Performance scores improved significantly from pre- to post-test for all groups (p < 0.001, ηp 2   = 0.55). However, group size did not affect transfer test performance on OSAUS scores (p = 0.13, ηp 2   = 0.06) or GRS scores (p = 0.23, ηp 2   = 0.05). ICAP analyses of training activities showed that time spent on non-learning and passive learning activities increased with group size (p < 0.001, ηp 2   = 0.31), whereas time spent on constructive and interactive learning activities was constant between groups compared with singles (p < 0.001, ηp 2   = 0.72).
CONCLUSION


Collaborative skills learning in groups of up to four did not impair skills transfer despite less hands-on time. This may be explained by a compensatory shift towards constructive and interactive learning activities that outweigh the effect of shorter hands-on time.",2022,Performance scores improved significantly from pre- to post-test for all groups (p<0.001 ηp 2  = 0.55).,['101 participants completed the simulation-based training and 97 completed the transfer-test'],"['skills training', 'obstetric ultrasound training']","['transfer test performance on OSAUS scores', 'Performance scores', 'time spent on constructive and interactive learning activities', 'Objective Structured Assessment of Ultrasound Skills (OSAUS) scale and a Global Rating Scale (GRS', 'GRS scores', 'time spent on non-learning and passive learning activities']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0412555', 'cui_str': 'Ultrasound scan - obstetric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0815244', 'cui_str': 'Interactive Learning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",101.0,0.0201491,Performance scores improved significantly from pre- to post-test for all groups (p<0.001 ηp 2  = 0.55).,"[{'ForeName': 'Laerke Marijke', 'Initials': 'LM', 'LastName': 'Noerholk', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation (CAMES), Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anne Mette', 'Initials': 'AM', 'LastName': 'Morcke', 'Affiliation': 'Centre for Educational Development, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kulamakan', 'Initials': 'K', 'LastName': 'Kulasegaram', 'Affiliation': 'Department of Family & Community Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Lone N', 'Initials': 'LN', 'LastName': 'Nørgaard', 'Affiliation': 'Center of Fetal Medicine, Department of Obstetrics, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Harmsen', 'Affiliation': 'Center of Fetal Medicine, Department of Obstetrics, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth Anita', 'Initials': 'LA', 'LastName': 'Andreasen', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation (CAMES), Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nina Gros', 'Initials': 'NG', 'LastName': 'Pedersen', 'Affiliation': 'Fetal Medicine Unit, Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev, Copenhagen, Denmark.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Johnsson', 'Affiliation': 'Center of Fetal Medicine, Department of Obstetrics, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anishan', 'Initials': 'A', 'LastName': 'Vamadevan', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation (CAMES), Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Martin Grønnebaek', 'Initials': 'MG', 'LastName': 'Tolsgaard', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation (CAMES), Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}]",Medical education,['10.1111/medu.14791']
555,35271380,"Comparison of Infant Bone Mineral Content and Density After Infant Daily Oral Vit D 400 IU Supplementation Versus Nursing Mother Oral 6,400 IU Supplementation: A Randomized Controlled Lactation Study.","Background:  Vitamin D (vitD) plays a major role in maintenance of bone mineral homeostasis. It is unknown if bone mineral content (BMC) and bone mineral density (BMD) differ between infants who receive direct vitD supplementation and those who receive vitD indirectly via their mother's breast milk, while she received a high dose of vitD. It is hypothesized that there would be no differences in BMC or BMD by treatment group.  Design/Methods:  Randomized, double-blind trial to compare BMD and BMC of infants who received direct vitD (400 IU vitD 3 /day) in addition to their mother receiving standard dosage (400 IU vitD 3 /day) versus infants whose mothers were their only source of vitD and were given high-dose supplementation (6,400 IU vitD 3 /day). Participants were exclusively breastfeeding mothers and their infant consuming only human milk. Infant BMC and BMD were measured by dual-energy X-ray absorptiometry (DXA) scans of the infant's total body using Hologic Discovery A Densitometer and analyzed using Hologic Infant software at 1, 4, and 7 months of age.  Results:  Infant BMC and BMD did not differ significantly at 1, 4, or 7 months of age between direct and indirect supplementation arms. The mean difference in BMC from 1 to 7 months was 1.624 and 1.464 g for the 400 and 6,400 IU groups, respectively, ( p  = 0.5); the mean difference in BMD over this same period was 0.042 and 0.032 g/cm 2  for the 400 and 6,400 IU groups, respectively ( p  = 0.2). Although some differences among races were observed, this did not reflect changes in bone growth between the treatment arms.  Conclusion:  High-dose vitD supplementation of mothers during lactation provided an efficacious alternative to direct supplementation of infants, as evidenced by noninferior infant BMD and BMC. Clinical Trial Registration number: NCT00412074.",2022,"The mean difference in BMC from 1 to 7 months was 1.624 and 1.464 g for the 400 and 6,400 IU groups, respectively, ( p  = 0.5); the mean difference in BMD over this same period was 0.042 and 0.032 g/cm 2  for the 400 and 6,400 IU groups, respectively ( p  = 0.2).","['Participants were exclusively breastfeeding mothers and their infant consuming only human milk', 'infants who received direct']","['Vitamin D (vitD', '400 IU Supplementation Versus Nursing Mother Oral 6,400 IU Supplementation', 'Oral Vit D']","['bone mineral content (BMC) and bone mineral density (BMD', 'vitD', 'BMC', 'Infant BMC and BMD', 'BMD', 'bone growth']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0971859', 'cui_str': 'Bone Growth'}]",,0.270069,"The mean difference in BMC from 1 to 7 months was 1.624 and 1.464 g for the 400 and 6,400 IU groups, respectively, ( p  = 0.5); the mean difference in BMD over this same period was 0.042 and 0.032 g/cm 2  for the 400 and 6,400 IU groups, respectively ( p  = 0.2).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andrews', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Phlegar', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Baatz', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}, {'ForeName': 'Myla D', 'Initials': 'MD', 'LastName': 'Ebeling', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Shary', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Gregoski', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Howard', 'Affiliation': 'Department of Pediatrics, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Wagner', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2021.0281']
556,35278124,Differential effects of the translocator protein 18 kDa (TSPO) ligand etifoxine and the benzodiazepine alprazolam on startle response to predictable threat in a NPU-threat task after acute and short-term treatment.,"RATIONALE


Benzodiazepines have been extensively investigated in experimental settings especially after single administration, which mostly revealed effects on unpredictable threat (U-threat) rather than predictable threat (P-threat). Given the need for pharmacological alternatives with a preferable side-effect profile and to better represent clinical conditions, research should cover also other anxiolytics and longer application times.
OBJECTIVES


The present study compared the acute and short-term effects of the translocator protein 18 kDa (TSPO) ligand etifoxine and the benzodiazepine alprazolam on P-threat and U-threat while controlling for sedation.
METHODS


Sixty healthy male volunteers, aged between 18 and 55 years, were randomly assigned to receive a daily dose of either 150 mg etifoxine, 1.5 mg alprazolam, or placebo for 5 days. On days 1 and 5 of intake, they performed a NPU-threat task including neutral (N), predictable (P), and unpredictable (U) conditions, while startle responsivity and self-reports were studied. Sedative effects were assessed using a continuous performance test.
RESULTS


Neither alprazolam nor etifoxine affected startle responsivity to U-threat on any of the testing days. While etifoxine reduced the startle response to P-threat on day 1 of treatment for transformed data, a contrary effect of alprazolam was found for raw values. No effects on self-reports and no evidence of sedation could be observed for either drug.
CONCLUSIONS


None of the anxiolytic substances had an impact on startle potentiation to U-threat even after several days of intake. The effects of the anxiolytics on startle responsivity to P-threat as well as implications for future studies are discussed.",2022,None of the anxiolytic substances had an impact on startle potentiation to U-threat even after several days of intake.,"['Sixty healthy male volunteers, aged between 18 and 55\xa0years']","['etifoxine', 'etifoxine, 1.5\xa0mg alprazolam, or placebo', 'alprazolam', 'anxiolytics', 'translocator protein 18\xa0kDa (TSPO', 'benzodiazepine alprazolam']","['NPU-threat task including neutral (N), predictable (P), and unpredictable (U) conditions, while startle responsivity and self-reports', 'Sedative effects', 'startle response']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0059678', 'cui_str': 'etifoxine'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0054966', 'cui_str': 'Lymphocyte antigen CD59'}, {'cui': 'C1532717', 'cui_str': 'kDa'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C0038186', 'cui_str': 'Startle Reaction'}]",60.0,0.04021,None of the anxiolytic substances had an impact on startle potentiation to U-threat even after several days of intake.,"[{'ForeName': 'Lisa-Marie', 'Initials': 'LM', 'LastName': 'Brunner', 'Affiliation': 'Department of Medicine, Psychiatry and Psychotherapy, University Regensburg, 93053, Regensburg, Germany. lisa-marie.brunner@medbo.de.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Maurer', 'Affiliation': 'Department of Medicine, Psychiatry and Psychotherapy, University Regensburg, 93053, Regensburg, Germany.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': 'Department of Medicine, Psychiatry and Psychotherapy, University Regensburg, 93053, Regensburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Weigl', 'Affiliation': 'Department of Medicine, Psychiatry and Psychotherapy, University Regensburg, 93053, Regensburg, Germany.'}, {'ForeName': 'Vladimir M', 'Initials': 'VM', 'LastName': 'Milenkovic', 'Affiliation': 'Department of Medicine, Psychiatry and Psychotherapy, University Regensburg, 93053, Regensburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rupprecht', 'Affiliation': 'Department of Medicine, Psychiatry and Psychotherapy, University Regensburg, 93053, Regensburg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Nothdurfter', 'Affiliation': 'Department of Medicine, Psychiatry and Psychotherapy, University Regensburg, 93053, Regensburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mühlberger', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University Regensburg, Regensburg, Germany.'}]",Psychopharmacology,['10.1007/s00213-022-06111-x']
557,35260824,Giving parents support: a randomized trial of peer support for parents after NICU discharge.,"BACKGROUND


Peer support during inpatient hospitalization has been recommended for NICU parents and can improve maternal mental health. Less is known about the impact of peer support after NICU discharge on parental mental health and infant healthcare utilization.
METHODS


Three hundred families of infants approaching discharge from a Level IV NICU were randomized to receive a care notebook (control) or care notebook plus peer support for 12 months (intervention). Participants reported on measures of stress, depression, anxiety, self-efficacy, and infant healthcare utilization. Analysis compared outcomes between control and treatment groups.
RESULTS


Parental depression, anxiety, stress, and self-efficacy improved significantly for all participants, yet there were no differences between control and intervention groups. Infant ED visits, hospitalizations, immunization status, and developmental status at 12 months did not differ between groups.
CONCLUSIONS


Peer support after NICU discharge did not improve self-reported parental mental health measures or infant healthcare utilization.
CLINICAL TRIAL REGISTRATION


NCT02643472.",2022,"Parental depression, anxiety, stress, and self-efficacy improved significantly for all participants, yet there were no differences between control and intervention groups.","['Three hundred families of infants approaching discharge from a Level IV NICU', 'parents after NICU discharge']",['care notebook (control) or care notebook plus peer support for 12 months (intervention'],"['Parental depression, anxiety, stress, and self-efficacy', 'Infant ED visits, hospitalizations, immunization status, and developmental status', 'stress, depression, anxiety, self-efficacy, and infant healthcare utilization']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0552506', 'cui_str': 'Immunization status'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",300.0,0.164054,"Parental depression, anxiety, stress, and self-efficacy improved significantly for all participants, yet there were no differences between control and intervention groups.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Fratantoni', 'Affiliation': ""Division of General and Community Pediatrics, Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Lamia', 'Initials': 'L', 'LastName': 'Soghier', 'Affiliation': ""Center for Translational Science, Children's Research Institute, Children's National Hospital, Washington, DC, USA. lsoghier@childrensnational.org.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kritikos', 'Affiliation': ""Center for Translational Science, Children's Research Institute, Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Jacangelo', 'Affiliation': ""Center for Translational Science, Children's Research Institute, Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Herrera', 'Affiliation': ""Center for Translational Science, Children's Research Institute, Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tuchman', 'Affiliation': ""Center for Translational Science, Children's Research Institute, Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Glass', 'Affiliation': ""Center for Translational Science, Children's Research Institute, Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Streisand', 'Affiliation': ""Center for Translational Science, Children's Research Institute, Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Marni', 'Initials': 'M', 'LastName': 'Jacobs', 'Affiliation': ""Center for Translational Science, Children's Research Institute, Children's National Hospital, Washington, DC, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-022-01341-5']
558,35260787,Cortical dopamine reduces the impact of motivational biases governing automated behaviour.,"Motivations shape our behaviour: the promise of reward invigorates, while in the face of punishment, we hold back. Abnormalities of motivational processing are implicated in clinical disorders characterised by excessive habits and loss of top-down control, notably substance and behavioural addictions. Striatal and frontal dopamine have been hypothesised to play complementary roles in the respective generation and control of these motivational biases. However, while dopaminergic interventions have indeed been found to modulate motivational biases, these previous pharmacological studies used regionally non-selective pharmacological agents. Here, we tested the hypothesis that frontal dopamine controls the balance between Pavlovian, bias-driven automated responding and instrumentally learned action values. Specifically, we examined whether selective enhancement of cortical dopamine either (i) enables adaptive suppression of Pavlovian control when biases are maladaptive; or (ii) non-specifically modulates the degree of bias-driven automated responding. Healthy individuals (n = 35) received the catechol-o-methyltransferase (COMT) inhibitor tolcapone in a randomised, double-blind, placebo-controlled cross-over design, and completed a motivational Go NoGo task known to elicit motivational biases. In support of hypothesis (ii), tolcapone globally decreased motivational bias. Specifically, tolcapone improved performance on trials where the bias was unhelpful, but impaired performance in bias-congruent conditions. These results indicate a non-selective role for cortical dopamine in the regulation of motivational processes underpinning top-down control over automated behaviour. The findings have direct relevance to understanding neurobiological mechanisms underpinning addiction and obsessive-compulsive disorders, as well as highlighting a potential trans-diagnostic novel mechanism to address such symptoms.",2022,"Specifically, tolcapone improved performance on trials where the bias was unhelpful, but impaired performance in bias-congruent conditions.",['Healthy individuals (n\u2009=\u200935) received the'],"['catechol-o-methyltransferase (COMT) inhibitor tolcapone', 'tolcapone', 'placebo-controlled cross-over design, and completed a motivational Go NoGo task known to elicit motivational biases']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",[],,0.111825,"Specifically, tolcapone improved performance on trials where the bias was unhelpful, but impaired performance in bias-congruent conditions.","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Scholz', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands. vanessa.scholz@donders.ru.nl.'}, {'ForeName': 'Roxanne W', 'Initials': 'RW', 'LastName': 'Hook', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mojtaba Rostami', 'Initials': 'MR', 'LastName': 'Kandroodi', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Algermissen', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Ioannidis', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Christmas', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Valle', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': 'Department of Psychology, and Behavioural and Clinical Neuroscience Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Grant', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Chamberlain', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Hanneke E M', 'Initials': 'HEM', 'LastName': 'den Ouden', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands. hanneke.denouden@donders.ru.nl.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-022-01291-8']
559,35262874,The Effects of Heart Rate Variability (HRV) Biofeedback on HRV Reactivity and Recovery During and After Anger Recall Task for Patients with Coronary Artery Disease.,"Patients with coronary artery disease (CAD) often experience anger events before cardiovascular events. Anger is a psychological risk factor and causes underlying psychophysiological mechanisms to lose balance of the autonomic nervous system (ANS). The heart rate variability (HRV) was the common index for ANS regulation. It has been confirmed that heart rate variability biofeedback (HRV-BF) restored ANS balance in patients with CAD during the resting state. However, the effects of HRV-BF during and after the anger event remain unknown. This study aimed to examine the effects of HRV-BF on ANS reactivity and recovery during the anger recall task in patients with CAD. This study was a randomized control trial with a wait-list control group design, with forty patients in the HRV-BF group (for six sessions) and 44 patients in the control group. All patients received five stages of an anger recall task, including baseline, neutral recall task, neutral recovery, anger recall task, and anger recovery. HRV reactivity in the HRV-BF group at the post-test was lower than that in the control group. HRV recovery at the post-test in the HRV-BF group was higher than that in the control group. The HRV-BF reduced ANS reactivity during anger events and increased ANS recovery after anger events for CAD patients. The possible mechanisms of HRV-BF may increase total HRV, ANS regulation, and baroreflex activation at anger events for patients with CAD, and may be a suitable program for cardiac rehabilitation.",2022,HRV reactivity in the HRV-BF group at the post-test was lower than that in the control group.,"['patients with CAD', 'Patients with Coronary Artery Disease', 'patients with CAD during the resting state', 'forty patients in the HRV-BF group (for six sessions) and 44 patients in the control group', 'Patients with coronary artery disease (CAD']","['Heart Rate Variability (HRV) Biofeedback', 'HRV-BF']","['neutral recall task, neutral recovery, anger recall task, and anger recovery', 'HRV reactivity', 'HRV recovery', 'HRV Reactivity and Recovery', 'total HRV, ANS regulation, and baroreflex activation', 'heart rate variability (HRV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}]",,0.0698928,HRV reactivity in the HRV-BF group at the post-test was lower than that in the control group.,"[{'ForeName': 'I-Mei', 'Initials': 'IM', 'LastName': 'Lin', 'Affiliation': 'Department of Psychology, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Pei-Yun', 'Initials': 'PY', 'LastName': 'Lin', 'Affiliation': 'Department of Psychology, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Fan', 'Affiliation': 'Institute of Gerontology, College of Medicine, National Cheng Kung University, No. 1, University Road, Tainan City, 701, Taiwan. shengyu@mail.ncku.edu.tw.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-022-09539-1']
560,35262718,Use of Machine Learning to Estimate the Per-Protocol Effect of Low-Dose Aspirin on Pregnancy Outcomes: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


In randomized clinical trials (RCTs), per-protocol effects may be of interest in the presence of nonadherence with the randomized treatment protocol. Using machine learning in per-protocol effect estimation can help avoid model misspecification owing to strong parametric assumptions, as is common with standard methods (eg, logistic regression).
Objectives


To demonstrate the use of ensemble machine learning with augmented inverse probability weighting (AIPW) for per-protocol effect estimation in RCTs and to evaluate the per-protocol effect size of aspirin on pregnancy.
Design, Setting, and Participants


This secondary analysis used data from 1227 women in the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, a multicenter, block-randomized, double-blind, placebo-controlled clinical trial of the effect of daily low-dose aspirin on pregnancy outcomes in women at high risk of pregnancy loss. Participants were recruited at 4 university medical centers in the US from June 15, 2007, to July 15, 2012. Women were followed up for 6 menstrual cycles for attempted pregnancy and 36 weeks of gestation if pregnancy occurred. Follow-up was completed on August 17, 2012. Data analyses were performed on July 9, 2021.
Exposures


Daily low-dose (81 mg) aspirin taken at least 5 of 7 days per week for at least 80% of follow-up time relative to placebo.
Main Outcomes and Measures


Pregnancy detected using human chorionic gonadotropin (hCG) levels.
Results


Among the 1227 women included in the analysis (mean SD age, 28.74 [4.80] years), 1161 (94.6%) were non-Hispanic White and 858 (69.9%) adhered to the protocol. Five machine learning models were combined into 1 meta-algorithm, which was used to construct an AIPW estimator for the per-protocol effect. Compared with adhering to placebo, adherence to the daily low-dose aspirin protocol for at least 5 of 7 days per week was associated with an increase in the probability of hCG-detected pregnancy of 8.0 (95% CI, 2.5-13.6) more hCG-detected pregnancies per 100 women in the sample, which is substantially larger than the estimated intention-to-treat estimate of 4.3 (95% CI, -1.1 to 9.6) more hCG-detected pregnancies per 100 women in the sample.
Conclusions and Relevance


These findings suggest that a low-dose aspirin protocol is associated with increased hCG-detected pregnancy in women who adhere to treatment for at least 5 days per week. With the presence of nonadherence, per-protocol treatment effect estimates differ from intention-to-treat estimates in the EAGeR trial. The results of this secondary analysis of clinical trial data suggest that machine learning could be used to estimate per-protocol effects by adjusting for confounders related to nonadherence in a more flexible way than traditional regressions.
Trial Registration


ClinicalTrials.gov Identifier: NCT00467363.",2022,"With the presence of nonadherence, per-protocol treatment effect estimates differ from intention-to-treat estimates in the EAGeR trial.","['1227 women in the Effects of', 'women at high risk of pregnancy loss', 'Participants were recruited at 4 university medical centers in the US from June 15, 2007, to July 15, 2012', '1227 women included in the analysis (mean SD age, 28.74 [4.80] years), 1161 (94.6%) were non-Hispanic White and 858 (69.9%) adhered to the protocol']","['Machine Learning', 'daily low-dose aspirin', 'placebo', 'aspirin', 'Aspirin', 'machine learning', 'Low-Dose Aspirin', 'Exposures\n\n\nDaily low-dose (81 mg) aspirin', 'ensemble machine learning']","['probability of hCG-detected pregnancy', 'probability weighting (AIPW', 'Pregnancy Outcomes', 'human chorionic gonadotropin (hCG) levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.573329,"With the presence of nonadherence, per-protocol treatment effect estimates differ from intention-to-treat estimates in the EAGeR trial.","[{'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Kennedy', 'Affiliation': 'Department of Data Science and Statistics, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Bodnar', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ashley I', 'Initials': 'AI', 'LastName': 'Naimi', 'Affiliation': 'Department of Epidemiology, Emory University, Atlanta, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.43414']
561,35266085,"A Double-Blind, Placebo-Controlled Study of Appropriate Site of Botulinum Toxin Therapy in Hemifacial Spasm.","INTRODUCTION


Hemifacial spasm (HFS) is a condition causing poor quality of life. Treatment with botulinum toxin A (BTX) injection is effective. Only one randomized controlled trial with a single-blind fashion has evaluated if oral injection is needed in HFS. The present study aimed to evaluate the necessity of oral BTX injection in HFS by a randomized, double-blind, placebo-controlled method.
METHODS


We conducted a double-blind, placebo-controlled trial in patients with HFS who never received BTX treatment. Eligible patients randomly received either 15 units of BTX around the eye and normal saline around the mouth (group A) or 15 units of BTX around both the eye and the mouth (group B). The primary outcomes were self-reported symptoms and observed frequency of spasms, while the secondary outcome was the duration of improvement or the time between the injection and the recurrence of symptoms to the same condition as before treatment. Student t test and survival analyses were used to compare the duration of symptoms between both groups. The mean changes were compared to secondary outcomes between the two groups.
RESULTS


There were 60 patients enrolled, half in each group. Baseline characteristics between both groups were similar. The mean (SD) of the duration of improvement in group A and B was 22.97 (18.85) and 17.53 (14.90) weeks, respectively (p = 0.220). There was no difference between both groups by survival analysis. Group B had a higher percentage of mouth improvement but there was no difference in the percentage of eye improvement, visual analog scale of eye and mouth spasm, or frequency of eye and mouth spasm. Group B had a higher incidence of side effects particularly mouth drooping (30% vs 10%) than group A (p = 0.053).
CONCLUSION


The mouth injection of BTX may not be necessary for HFS. It may be beneficial to reduce mouth symptoms with a higher rate of mouth drooping.",2022,"Group B had a higher percentage of mouth improvement but there was no difference in the percentage of eye improvement, visual analog scale of eye and mouth spasm, or frequency of eye and mouth spasm.","['60 patients enrolled, half in each group', 'Hemifacial Spasm', 'patients with HFS who never received BTX treatment']","['botulinum toxin\xa0A (BTX) injection', 'BTX', 'placebo', 'Placebo', 'BTX injection', '15\xa0units of BTX around the eye and normal saline around the mouth (group\xa0A) or 15\xa0units of BTX', 'Botulinum Toxin Therapy']","['duration of improvement or the time between the injection and the recurrence of symptoms', 'percentage of eye improvement, visual analog scale of eye and mouth spasm, or frequency of eye and mouth spasm', 'self-reported symptoms and observed frequency of spasms', 'percentage of mouth improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0278152', 'cui_str': 'Hemifacial spasm'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",60.0,0.275149,"Group B had a higher percentage of mouth improvement but there was no difference in the percentage of eye improvement, visual analog scale of eye and mouth spasm, or frequency of eye and mouth spasm.","[{'ForeName': 'Suthipun', 'Initials': 'S', 'LastName': 'Jitpimolmard', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Khon Kaen University, 123 Mitraparp Rd., Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Bandit', 'Initials': 'B', 'LastName': 'Thinkhamrop', 'Affiliation': 'Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Somsak', 'Initials': 'S', 'LastName': 'Tiamkao', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Khon Kaen University, 123 Mitraparp Rd., Khon Kaen, 40002, Thailand. somtia@kku.ac.th.'}, {'ForeName': 'Suwanna', 'Initials': 'S', 'LastName': 'Arunpongpaisal', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Preeda', 'Initials': 'P', 'LastName': 'Arayavichanon', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Weerachai', 'Initials': 'W', 'LastName': 'Kosuwan', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Siriya', 'Initials': 'S', 'LastName': 'Jitpimolmard', 'Affiliation': 'School of Communication Arts, Bangkok University, Pathum Thani, Thailand.'}, {'ForeName': 'Kittisak', 'Initials': 'K', 'LastName': 'Sawanyawisuth', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Khon Kaen University, 123 Mitraparp Rd., Khon Kaen, 40002, Thailand. kittisak@kku.ac.th.'}]",Advances in therapy,['10.1007/s12325-022-02077-6']
562,35272880,The Effect of Alendronate on Bone Mineral Disorder in Renal Transplant Patients.,"PURPOSE


In this study, we aimed to investigate the effect of long-term administration of alendronate to treat bone loss in renal transplant patients.
METHODS


Eighty-two renal transplant recipients were divided into 3 groups. Group 1 included patients who were treated with calcium, vitamin D3, and alendronate; group 2 included patients who were treated with calcium and vitamin D3; and group 3 included patients who did not receive these medications. All patients' sociodemographic data, biochemical parameters, and bone mineral density (BMD) measurements were recorded.
RESULTS


There were no significant differences between sociodemographic and laboratory findings at the beginning of study in all groups. The BMD of lumbar spine and femoral neck was significantly less in group 1 at the beginning, 12 and 24 months of the study when compared with other group. At 12 and 24 months of the study, the BMD levels were decreased both group 2 and group 3, whereas in group 1, it was stable at 12 months and increased thereafter. In group 1, the initial femoral neck BMD was negatively correlated with parathormone, sex, and body mass index, and positively correlated with creatinine level. While there was a positive correlation between basal body mass index and femur neck BMD in group 2, there was no correlation between baseline parameters, demographic data, and bone mineral density in group 3 patients.
CONCLUSIONS


In conclusion, bone loss is inevitable despite calcium and vitamin D replacement. However, bone loss can be stopped and even reversed with alendronate therapy.",2022,"The BMD of lumbar spine and femoral neck was significantly less in group 1 at the beginning, 12 and 24 months of the study when compared with other group.","['Eighty-two renal transplant recipients', 'group 2 included patients who were treated with', 'renal transplant patients', 'Renal Transplant Patients']","['alendronate', 'calcium and vitamin D3', 'calcium, vitamin D3, and alendronate', 'Alendronate']","['Bone Mineral Disorder', 'BMD of lumbar spine and femoral neck', 'basal body mass index and femur neck BMD', 'demographic data, and bone mineral density', 'BMD levels', 'bone loss', 'initial femoral neck BMD', 'bone mineral density (BMD) measurements']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3536735', 'cui_str': 'Basal Body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",82.0,0.0065671,"The BMD of lumbar spine and femoral neck was significantly less in group 1 at the beginning, 12 and 24 months of the study when compared with other group.","[{'ForeName': 'Zuhal Atan', 'Initials': 'ZA', 'LastName': 'Uçar', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Medical Faculty, TC Demiroğlu Bilim University, İstanbul, Turkey. Electronic address: zuhal1214@gmail.com.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Sinangil', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Medical Faculty, TC Demiroğlu Bilim University, İstanbul, Turkey.'}, {'ForeName': 'Yener', 'Initials': 'Y', 'LastName': 'Koç', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Medical Faculty, Sivas Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'I Soykan', 'Initials': 'IS', 'LastName': 'Barlas', 'Affiliation': 'Unit of Renal Transplantation, Department of General Surgery, Medical Faculty, TC Demiroğlu Bilim University, İstanbul, Turkey.'}, {'ForeName': 'S Tevfik', 'Initials': 'ST', 'LastName': 'Ecder', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Medical Faculty, TC Demiroğlu Bilim University, İstanbul, Turkey.'}, {'ForeName': 'Emin Baris', 'Initials': 'EB', 'LastName': 'Akin', 'Affiliation': 'Unit of Renal Transplantation, Department of General Surgery, Medical Faculty, TC Demiroğlu Bilim University, İstanbul, Turkey.'}]",Transplantation proceedings,['10.1016/j.transproceed.2022.01.016']
563,35275197,"Temozolomide and Radiotherapy versus Radiotherapy Alone in Patients with Glioblastoma, IDH-wildtype: Post Hoc Analysis of the EORTC Randomized Phase III CATNON Trial.","PURPOSE


In a post hoc analysis of the CATNON trial (NCT00626990), we explored whether adding temozolomide to radiotherapy improves outcome in patients with IDH1/2 wildtype (wt) anaplastic astrocytomas with molecular features of glioblastoma [redesignated as glioblastoma, isocitrate dehydrogenase-wildtype (IDH-wt) in the 2021 World Health Organization (WHO) classification of central nervous system tumors].
PATIENTS AND METHODS


From the randomized phase III CATNON study examining the addition of adjuvant and concurrent temozolomide to radiotherapy in anaplastic astrocytomas, we selected a subgroup of IDH1/2wt and H3F3Awt tumors with presence of TERT promoter mutations and/or EGFR amplifications and/or combined gain of chromosome 7 and loss of chromosome 10. Molecular abnormalities including MGMT promoter methylation status were determined by next-generation sequencing, DNA methylation profiling, and SNaPshot analysis.
RESULTS


Of the 751 patients entered in the CATNON study, 670 had fully molecularly characterized tumors. A total of 159 of these tumors met the WHO 2021 molecular criteria for glioblastoma, IDH-wt. Of these patients, 47 received radiotherapy only and 112 received a combination of radiotherapy and temozolomide. There was no added effect of temozolomide on either overall survival [HR, 1.19; 95% confidence interval (CI), 0.82-1.71] or progression-free survival (HR, 0.87; 95% CI, 0.61-1.24). MGMT promoter methylation was prognostic for overall survival, but was not predictive for outcome to temozolomide treatment either with respect to overall survival or progression-free survival.
CONCLUSIONS


In this cohort of patients with glioblastoma, IDH-wt temozolomide treatment did not add benefit beyond that observed from radiotherapy, regardless of MGMT promoter status. These findings require a new well-powered prospective clinical study to explore the efficacy of temozolomide treatment in this patient population.",2022,"MGMT promoter methylation was prognostic for overall survival, but was not predictive for outcome to temozolomide treatment either with respect to overall survival or progression-free survival.
","['751 patients entered in the CATNON study, 670 had fully molecularly characterized tumors', 'patients with glioblastoma, IDH-wildtype', 'anaplastic astrocytomas, we selected a subgroup of IDH1/2wt and H3F3Awt tumors with presence of TERT promoter mutations and/or EGFR amplifications and/or combined gain of chromosome 7 and loss of chromosome 10', '159 of these tumors met the WHO 2021 molecular criteria for glioblastoma, IDH-wildtype', 'patients with IDH1/2wt anaplastic astrocytomas with molecular features of glioblastoma (redesignated as glioblastoma, IDH-wildtype in the 2021 WHO classification of CNS tumors']","['temozolomide to radiotherapy', 'temozolomide', 'Temozolomide and radiotherapy versus radiotherapy alone', 'radiotherapy and temozolomide', 'radiotherapy']","['overall survival', 'progression-free survival', 'overall survival or progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0334579', 'cui_str': 'Astrocytoma, anaplastic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008670', 'cui_str': 'Chromosome pair 7'}, {'cui': 'C0008652', 'cui_str': 'Chromosome pair 10'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0085136', 'cui_str': 'Neoplasm of central nervous system'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",2021.0,0.163915,"MGMT promoter methylation was prognostic for overall survival, but was not predictive for outcome to temozolomide treatment either with respect to overall survival or progression-free survival.
","[{'ForeName': 'C Mircea S', 'Initials': 'CMS', 'LastName': 'Tesileanu', 'Affiliation': 'Neurology Department, Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sanson', 'Affiliation': 'Sorbonne Université, Inserm, CNRS, UMR S 1127, Paris Brain Institute - Institut du Cerveau (ICM), AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière - Charles Foix, Service de Neurologie 2-Mazarin, Paris, France.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurology Department, University of Heidelberg, and Clinical Cooperation Unit Neurooncology, German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Medical Oncology Department, AUSL-IRCCS Scienze Neurologiche, Bologna, Italy.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Oncology Department, KU Leuven and General Medical Oncology Department, UZ Leuven, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Erridge', 'Affiliation': 'Edinburgh Centre for Neuro-Oncology, Western General Hospital, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': 'Neuro-Oncology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'Medical School, University of Western Australia, Crawley, Western Australia.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Baurain', 'Affiliation': 'Medical Oncology Department, King Albert II Cancer Institute, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Warren P', 'Initials': 'WP', 'LastName': 'Mason', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Wheeler', 'Affiliation': 'Northern Sydney Cancer Centre, University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Olivier L', 'Initials': 'OL', 'LastName': 'Chinot', 'Affiliation': 'Aix-Marseille University, AP-HM, Neuro-Oncology division, Marseille, France.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'Medical Oncology Department, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Clinical Oncology Department, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Leland', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': 'Radiation Oncology Department, Gammawest Cancer Services, Salt Lake City, Utah.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Taal', 'Affiliation': 'Neurology Department, Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rudà', 'Affiliation': 'Neuro-Oncology Department, City of Health and Science Hospital and University of Turin, Turin, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Neurology Department, Clinical Neuroscience Center, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'McBain', 'Affiliation': 'Clinical Oncology Department, The Christie NHS FT, Manchester, United Kingdom.'}, {'ForeName': 'Myra E', 'Initials': 'ME', 'LastName': 'van Linde', 'Affiliation': 'Medical Oncology Department, Brain Tumor Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Aldape', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Jenkins', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Johan M', 'Initials': 'JM', 'LastName': 'Kros', 'Affiliation': 'Pathology Department, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Wesseling', 'Affiliation': 'Pathology Department, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'von Deimling', 'Affiliation': 'Neuropathology Department, Ruprecht-Karls-University, and CCU Neuropathology German Cancer Institute and Consortium, DKFZ, and DKTK, Heidelberg, Germany.'}, {'ForeName': 'Youri', 'Initials': 'Y', 'LastName': 'Hoogstrate', 'Affiliation': 'Neurology Department, Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'de Heer', 'Affiliation': 'Neurology Department, Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Peggy N', 'Initials': 'PN', 'LastName': 'Atmodimedjo', 'Affiliation': 'Pathology Department, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Hendrikus J', 'Initials': 'HJ', 'LastName': 'Dubbink', 'Affiliation': 'Pathology Department, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Rutger W W', 'Initials': 'RWW', 'LastName': 'Brouwer', 'Affiliation': 'Center for Biomics, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Wilfred F J', 'Initials': 'WFJ', 'LastName': 'van IJcken', 'Affiliation': 'Center for Biomics, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Kin Jip', 'Initials': 'KJ', 'LastName': 'Cheung', 'Affiliation': 'EORTC HQ, Brussels, Belgium.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'EORTC HQ, Brussels, Belgium.'}, {'ForeName': 'Brigitta G', 'Initials': 'BG', 'LastName': 'Baumert', 'Affiliation': 'Radiation-Oncology Department (MAASTRO), Maastricht University Medical Center (MUMC) and GROW (School for Oncology), Maastricht, the Netherlands.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'EORTC HQ, Brussels, Belgium.'}, {'ForeName': 'Pim J', 'Initials': 'PJ', 'LastName': 'French', 'Affiliation': 'Neurology Department, Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Neurology Department, Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-4283']
564,35275196,"Effect of AZD4017, a Selective 11β-HSD1 Inhibitor, on Bone Turnover Markers in Postmenopausal Osteopenia.","CONTEXT


The causative link between circulating glucocorticoid excess and osteoporosis is well-established. The enzyme 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1), which increases local cortisol production, is expressed in human osteoblasts and its activity increases with age.
OBJECTIVE


We hypothesized that local 11β-HSD1 might mediate an age-related decrease in bone formation and that selective 11β-HSD1 inhibition may enhance bone formation.
METHODS


A dual-center, phase II, randomized, double-blind, placebo-controlled trial of 90 days' treatment with AZD4017 (a selective 11β-HSD1 inhibitor) was conducted in 55 postmenopausal women with osteopenia. Participants received 400 mg oral AZD4017 twice daily vs matched placebo over 90 days. The primary outcome measure was the impact on the bone formation marker osteocalcin. Secondary objectives included correlation with 11β-HSD1 activity.
RESULTS


At 90 days, osteocalcin levels did not differ between treatment groups: active (mean 22.3 [SD 8.6] ng/mL, n = 22) and placebo (21.7 [SD 9.2] ng/mL, n = 24), with a baseline-adjusted treatment effect of 0.95 (95% CI: -2.69, 4.60). The results from the urinary [THF + alloTHF]/THE ratio (index of 11β-HSD1 activity) and the urinary cortisol/cortisone ratio (index of 11β-HSD2 activity) confirmed a > 90% inhibition of 11β-HSD1 but no change in activity of 11β-HSD2.
CONCLUSION


This trial demonstrates that AZD4017 selectively inhibits 11β-HSD1 activity in vivo in a safe and reversible manner. Following 90 days of treatment, there is no effect on bone formation, indicating that the relative impairment of bone mineral density in postmenopausal women is not mediated by local intracellular production of cortisol under normal physiological concentrations.",2022,"At 90 days the levels of osteocalcin did not differ between the treatment groups, active [mean 22.3 (","['post-menopausal osteopenia', '55 post-menopausal women with osteopenia were recruited']","['oral AZD4017', 'AZD4017', 'placebo']","['local cortisol production', '11β-HSD1 activity', 'urinary [THF+alloTHF]/THE ratio (index of 11β-HSD1 activity) and the urinary cortisol/cortisone ratio (index of 11β-HSD2 activity', 'activity of 11β-HSD2', 'bone turnover markers', 'bone formation', 'levels of osteocalcin', 'bone mineral density', 'bone formation marker, osteocalcin']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3501337', 'cui_str': 'AZD4017'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",4017.0,0.204527,"At 90 days the levels of osteocalcin did not differ between the treatment groups, active [mean 22.3 (","[{'ForeName': 'Afroze', 'Initials': 'A', 'LastName': 'Abbas', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, and Leeds Teaching Hospitals NHS Trust, Leeds LS9 7TF, UK.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Schini', 'Affiliation': 'Academic Unit of Bone Metabolism, University of Sheffield, Sheffield S5 7AU, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Ainsworth', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Oughton', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Crowley', 'Affiliation': 'School of Medicine and Medical Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Cooper', 'Affiliation': 'Concord Clinical School, Faculty of Medicine & Health, University of Sydney, NSW 2139, Australia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Fairclough', 'Affiliation': 'Emerging Innovations Unit, Discovery Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, University of Sheffield, Sheffield S5 7AU, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Stewart', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, and Leeds Teaching Hospitals NHS Trust, Leeds LS9 7TF, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac100']
565,35278689,Boosting visual perceptual learning by transcranial alternating current stimulation over the visual cortex at alpha frequency.,"BACKGROUND


Transcranial alternating current stimulation (tACS) has been widely used to alter ongoing brain rhythms in a frequency-specific manner to modulate relevant cognitive functions, including visual functions. Therefore, it is a useful tool for exploring the causal role of neural oscillations in cognition. Visual functions can be improved substantially by training, which is called visual perceptual learning (VPL). However, whether and how tACS can modulate VPL is still unclear.
OBJECTIVE


This work aims to explore how tACS modulates VPL and the role of neural oscillations in VPL.
METHODS


A between-subjects design was adopted. Subjects were assigned to six groups and undertook five daily training sessions to execute an orientation discrimination task. During training, five groups received occipital tACS stimulation at 6, 10, 20, 40, and sham 10 Hz respectively, and one group was stimulated at the sensorimotor regions by 10 Hz tACS.
RESULTS


Compared with the sham stimulation, occipital tACS at 10 Hz, but not at other frequencies, accelerated perceptual learning and increased the performance improvement. However, these modulatory effects were absent when 10 Hz tACS was delivered to the sensorimotor areas. Moreover, the tACS-induced performance improvement lasted at least two months after the end of training.
CONCLUSION


TACS can facilitate orientation discrimination learning in a frequency- and location-specific manner. Our findings provide strong evidence for a pivotal role of alpha oscillations in boosting VPL and shed new light on the design of effective neuromodulation protocols that can facilitate rehabilitation for patients with neuro-ophthalmological disorders.",2022,"Compared with the sham stimulation, occipital tACS at 10 Hz, but not at other frequencies, accelerated perceptual learning and increased the performance improvement.",['patients with neuro-ophthalmological disorders'],"['tACS', 'TACS', 'Transcranial alternating current stimulation (tACS', 'occipital tACS stimulation']",['Visual functions'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}]",,0.0394439,"Compared with the sham stimulation, occipital tACS at 10 Hz, but not at other frequencies, accelerated perceptual learning and increased the performance improvement.","[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, 100871, Beijing, China; Key Laboratory of Machine Perception, Ministry of Education, Peking University, 100871, Beijing, China; IDG/McGovern Institute for Brain Research, Peking University, 100871, Beijing, China; Peking-Tsinghua Center for Life Sciences, Peking University, 100871, Beijing, China.'}, {'ForeName': 'Xin-Yue', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, 100871, Beijing, China; Key Laboratory of Machine Perception, Ministry of Education, Peking University, 100871, Beijing, China; IDG/McGovern Institute for Brain Research, Peking University, 100871, Beijing, China; Peking-Tsinghua Center for Life Sciences, Peking University, 100871, Beijing, China.'}, {'ForeName': 'Baoqi', 'Initials': 'B', 'LastName': 'Gong', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, 100871, Beijing, China; Key Laboratory of Machine Perception, Ministry of Education, Peking University, 100871, Beijing, China; IDG/McGovern Institute for Brain Research, Peking University, 100871, Beijing, China; Peking-Tsinghua Center for Life Sciences, Peking University, 100871, Beijing, China.'}, {'ForeName': 'Keyan', 'Initials': 'K', 'LastName': 'Bi', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, 100871, Beijing, China; Key Laboratory of Machine Perception, Ministry of Education, Peking University, 100871, Beijing, China; IDG/McGovern Institute for Brain Research, Peking University, 100871, Beijing, China; Peking-Tsinghua Center for Life Sciences, Peking University, 100871, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, 100871, Beijing, China; Key Laboratory of Machine Perception, Ministry of Education, Peking University, 100871, Beijing, China; IDG/McGovern Institute for Brain Research, Peking University, 100871, Beijing, China; Peking-Tsinghua Center for Life Sciences, Peking University, 100871, Beijing, China. Electronic address: ffang@pku.edu.cn.'}]",Brain stimulation,['10.1016/j.brs.2022.02.018']
566,35278643,Erythrocyte Zn concentration and antioxidant response after supplementation with Zn in a postmenopausal population. A double-blind randomized trial.,"BACKGROUND & AIMS


Menopausal hormonal changes increase the risk of deficiencies of minerals such as zinc (Zn), which could further worsen the decreased antioxidant defense of postmenopausal women. This study assesses the effect of 8 weeks of Zn supplementation upon the antioxidant status and clinical nutritional parameters of a postmenopausal population.
METHODS


Fifty-one postmenopausal women were divided into two groups: placebo (PbG) and zinc supplementation (ZnG). Mineral status was determined by Flame Atomic Absorption Spectrophotometry (FAAS). Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD) were analyzed by kinetic colorimetric methods. Glutathione Peroxidase (GPx) was assessed by an enzymatic immunological method.
RESULTS


Poor Zn status was initially observed in erythrocyte samples. Total antioxidant capacity showed a significant correlation (r = 0.730; p < 0.05) to erythrocyte Zn after the intervention (ZnG: r = 0.96; p < 0.001). Moreover, erythrocyte Zn concentration in ZnG was positively correlated to GPx activity after the intervention (r = 0.61; p < 0.01).
CONCLUSIONS


The postmenopausal women initially presented Zn deficiency, and the status of this mineral improved after the intervention. Zinc supplementation may be an effective approach for correcting the observed deficiencies, enhancing antioxidant defense in this risk population.
CLINICAL TRIAL REGISTRATION


The present study is registered at the US National Institutes of Health (ClinicalTrials.gov), NCT03672513.",2022,Total antioxidant capacity showed a significant correlation (r = 0.730; p < 0.05) to erythrocyte Zn after the intervention (ZnG: r = 0.96; p < 0.001).,"['postmenopausal women', 'Fifty-one postmenopausal women']","['Zinc supplementation', 'placebo (PbG) and zinc supplementation (ZnG', 'Zn supplementation']","['Total antioxidant capacity', 'erythrocyte Zn in ZnG', 'Mineral status', 'Total antioxidant capacity (TAC) and superoxide dismutase (SOD', 'Glutathione peroxidase (GPx', 'erythrocyte samples']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",51.0,0.459419,Total antioxidant capacity showed a significant correlation (r = 0.730; p < 0.05) to erythrocyte Zn after the intervention (ZnG: r = 0.96; p < 0.001).,"[{'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Vázquez-Lorente', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Molina-López', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain; Faculty of Education, Psychology and Sports Sciences, University of Huelva, 21007 Huelva, Spain. Electronic address: jorge.molina@ddi.uhu.es.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Herrera-Quintana', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Yenifer', 'Initials': 'Y', 'LastName': 'Gamarra-Morales', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Bartolomé', 'Initials': 'B', 'LastName': 'Quintero-Osso', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'López-González', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Planells', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain. Electronic address: elenamp@ugr.es.'}]",Experimental gerontology,['10.1016/j.exger.2022.111766']
567,35266202,A one-time pneumatic jet-injection of 5-fluorouracil and triamcinolone acetonide for treatment of hypertrophic scars-A blinded randomized controlled trial.,"BACKGROUND


Patients with hypertrophic scars (HTS) risk reduced quality of life due to itching, pain, poor cosmesis, and restriction of movement. Despite good clinical efficacy, patients are often reluctant to undergo repeated needle injections due to pain or needle phobia.
OBJECTIVES


To evaluate the applicability of needle-free pneumatic jet injection (PJI) and assess changes in hypertrophic scars following a single PJI treatment with 5-fluorouracil (5-FU) and triamcinolone acetonide (TAC).
METHODS


Twenty patients completed this blinded, randomized, controlled, split-scar trial. The intervention side of the HTS received a one-time treatment with PJIs containing a mixture of TAC + 5-FU injected at 5 mm intervals (mean 7 PJI per HTS); the control side received no treatment. Assessments were made at baseline and 4 weeks posttreatment. Outcome measures included change in (1) Vancouver Scar Scale (VSS) total score and subscores, (2) scar volume and surface area assessed by three-dimensional imaging, (3) skin microarchitecture measured by optical-coherence tomography (OCT), (4) photo-assessed scar cosmesis (0-100), (5) patient-reported pain and satisfaction (0-10), and (6) depiction of drug biodistribution after PJI.
RESULTS


PJI with TAC + 5-FU significantly decreased both HTS height (-1 VSS; p = 0.01) and pliability (-1 VSS; p < 0.01) with a nonstatistically significant reduction of -1 in total VSS score (0 in control; p = 0.09). On 3D imaging, a 33% decrease in scar volume (p = 0.016) and a 37% decrease in surface area (p = 0.008) was observed. OCT indicated trends towards smoother scar surface (Ra 11.1-10.3; p = 0.61), normalized dermal microarchitecture (attenuation coefficient: 1.52-1.68; p = 0.44), and a reduction in blood flow between 9% and 17% (p = 0.50-0.79). Despite advances in VSS subscores and OCT, no improved photo-assessed cosmesis was found (-3.2 treatment vs. -1.4 control; p = 0.265). Patient-reported pain was low (2/10) and 90% of the patients that had previously received needle injections preferred PJI to needle injection. Depositions of TAC + FU were imaged reaching deep into the scar at levels corresponding to the reticular dermis.
CONCLUSION


A single PJI injection containing 5-FU and TAC can significantly improve the height and pliability of HTS. PJI is favored by the patients and may serve as a complement to conventional needle injections, especially for patients with needle phobia.",2022,"OCT indicated trends towards smoother scar surface (Ra 11.1-10.3; p = 0.61), normalized dermal microarchitecture (attenuation coefficient: 1.52-1.68; p = 0.44), and a reduction in blood flow between 9% and 17% (p = 0.50-0.79).","['Twenty patients', 'patients with needle phobia', 'hypertrophic scars', 'Patients with hypertrophic scars (HTS']","['5-fluorouracil and triamcinolone acetonide', 'PJIs containing a mixture of TAC\u2009+\u20095-FU', 'triamcinolone acetonide (TAC', '5-FU and TAC', 'needle-free pneumatic jet injection (PJI', '5-fluorouracil (5-FU', 'OCT']","['total VSS score', 'change in (1) Vancouver Scar Scale (VSS) total score and subscores, (2) scar volume and surface area assessed by three-dimensional imaging, (3) skin microarchitecture measured by optical-coherence tomography (OCT), (4) photo-assessed scar cosmesis (0-100), (5) patient-reported pain and satisfaction (0-10), and (6) depiction of drug biodistribution', 'pain', 'surface area', 'smoother scar surface', 'HTS height', 'blood flow', 'normalized dermal microarchitecture', 'height and pliability of HTS', 'VSS subscores and OCT, no improved photo-assessed cosmesis', 'scar volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338906', 'cui_str': 'Needle phobia'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021496', 'cui_str': 'Jet Injections'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0887832', 'cui_str': '3-D Imaging'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",20.0,0.154803,"OCT indicated trends towards smoother scar surface (Ra 11.1-10.3; p = 0.61), normalized dermal microarchitecture (attenuation coefficient: 1.52-1.68; p = 0.44), and a reduction in blood flow between 9% and 17% (p = 0.50-0.79).","[{'ForeName': 'Andrés M', 'Initials': 'AM', 'LastName': 'Erlendsson', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Lukas K', 'Initials': 'LK', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Catharina M', 'Initials': 'CM', 'LastName': 'Lerche', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Togsverd-Bo', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Stine R', 'Initials': 'SR', 'LastName': 'Wiegell', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Karmisholt', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Philipsen', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Anders C N', 'Initials': 'ACN', 'LastName': 'Hansen', 'Affiliation': 'Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Janfelt', 'Affiliation': 'Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Holmes', 'Affiliation': 'Michelson Diagnostics Ltd., Kent, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Haedersdal', 'Affiliation': 'Department of Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}]",Lasers in surgery and medicine,['10.1002/lsm.23529']
568,35274413,Evolution from a first clinical demyelinating event to multiple sclerosis in the REFLEX trial: Regional susceptibility in the conversion to multiple sclerosis at disease onset and its amenability to subcutaneous interferon beta-1a.,"BACKGROUND AND PURPOSE


In the REFLEX trial (ClinicalTrials.gov identifier: NCT00404352), patients with a first clinical demyelinating event (FCDE) displayed significantly delayed onset of multiple sclerosis (MS; McDonald criteria) when treated with subcutaneous interferon beta-1a (sc IFN β-1a) versus placebo. This post hoc analysis evaluated the effect of sc IFN β-1a on spatio-temporal evolution of disease activity, assessed by changes in T2 lesion distribution, in specific brain regions of such patients and its relationship with conversion to MS.
METHODS


Post hoc analysis of baseline and 24-month magnetic resonance imaging data from FCDE patients who received sc IFN β-1a 44 μg once or three times weekly, or placebo in the REFLEX trial. Patients were grouped according to McDonald MS status (converter/non-converter) or treatment (sc IFN β-1a/placebo). For each patient group, a baseline lesion probability map (LPM) and longitudinal new/enlarging and shrinking/disappearing LPMs were created. Lesion location/frequency of lesion occurrence were assessed in the white matter.
RESULTS


At Month 24, lesion frequency was significantly higher in the anterior thalamic radiation (ATR) and corticospinal tract (CST) of converters versus non-converters (p < 0.05). Additionally, the overall distribution of new/enlarging lesions across the brain at Month 24 was similar in placebo- and sc IFN β-1a-treated patients (ratio: 0.95). Patients treated with sc IFN β-1a versus placebo showed significantly lower new lesion frequency in specific brain regions (cluster corrected): ATR (p = 0.025), superior longitudinal fasciculus (p = 0.042), CST (p = 0.048), and inferior longitudinal fasciculus (p = 0.048).
CONCLUSIONS


T2 lesion distribution in specific brain locations predict conversion to McDonald MS and show significantly reduced new lesion occurrence after treatment with sc IFN β-1a in an FCDE population.",2022,"At Month 24, lesion frequency was significantly higher in the anterior thalamic radiation (ATR) and corticospinal tract (CST) of converters versus non-converters (p<0.05).",['patients with a first clinical demyelinating event (FCDE'],"['scIFNβ-1a 44 μg once or three times weekly, or placebo', 'scIFNβ-1a versus placebo', 'treatment (scIFNβ-1a/placebo', 'subcutaneous interferon β-1a (scIFNβ-1a) versus placebo']","['new lesion frequency in specific brain regions (cluster corrected): ATR', 'overall distribution of new/enlarging lesions', 'Lesion location/frequency of lesion occurrence', 'new lesion occurrence', 'lesion frequency', 'superior longitudinal fasciculus', 'baseline lesion probability map (LPM) and longitudinal new/enlarging and shrinking/disappearing LPMs', 'anterior thalamic radiation (ATR) and corticospinal tract (CST']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0228270', 'cui_str': 'Structure of superior longitudinal fasciculus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}]",,0.142576,"At Month 24, lesion frequency was significantly higher in the anterior thalamic radiation (ATR) and corticospinal tract (CST) of converters versus non-converters (p<0.05).","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Battaglini', 'Affiliation': 'Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Vrenken', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Tappa Brocci', 'Affiliation': 'Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.'}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': 'Gentile', 'Affiliation': 'Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Luchetti', 'Affiliation': 'Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Versteeg', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Bernard M J', 'Initials': 'BMJ', 'LastName': 'Uitdehaag', 'Affiliation': 'Department of Neurology, Amsterdam UMC, Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) and Neurology, Departments of Head, Spine and Neuromedicine, Biomedical Engineering and Clinical Research, University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Casa di Cura Privata del Policlinico, Università Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Seitzinger', 'Affiliation': 'Global Biostatistics, Merck Healthcare KGaA, Darmstadt, Germany.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Jack', 'Affiliation': 'Global Medical Affairs, Merck Serono Ltd (an affiliate of Merck KGaA), Feltham, UK.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'Department of Health Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'De Stefano', 'Affiliation': 'Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.'}]",European journal of neurology,['10.1111/ene.15314']
569,35285912,Antenatal Iron-Rich Food Intervention Prevents Iron-Deficiency Anemia but Does Not Affect Serum Hepcidin in Pregnant Women.,"BACKGROUND


Limited evidence supports the efficacy of iron-rich foods (IRFs) in improving iron status during pregnancy.
OBJECTIVES


The study aims to evaluate the effect of IRFs on iron status and biomarkers of iron metabolism in the third trimester of pregnancy.
METHODS


A total of 240 pregnant women at 11-13 wk of gestation without iron-deficiency anemia (IDA) in South China were recruited to this single-blind clinical trial [non-IDA referred to both hemoglobin (Hb) ≥110g/L and serum ferritin (SF) ≥15ng/mL],  randomly assigned to 1) control, 2) IRFs containing 20 mg iron/d (IRF-20), or 3) IRFs containing 40 mg iron/d (IRF-40). The IRFs were consumed 3 days a week, including pork liver, chicken/duck blood, soybean, and agaric. The IRFs started at recruitment and ended in the predelivery room. Primary outcome included anemia (Hb <110 g/L), iron deficiency (ID, definition 1: SF <15 ng/mL; definition 2: SF <12 ng/mL), and IDA (ID and Hb <110 g/L). Secondary outcome was plasma Hb and iron indices, including SF, serum hepcidin, and iron.
RESULTS


All participants who completed the trial with full data (n = 170) were included in the analysis. At the endline, both intervention groups showed lower ID and IDA rates than control. Specifically, IRF-40 showed a lower ID (SF <12 ng/mL) rate than control (9.0% compared with 22.8%, P = 0.022). For IDA by definition 1, the incidence in IRF-40 was lower than that in control (1.9% compared with 8.9%, P = 0.045). For IDA by definition 2, the incidence in IRF-20 was lower than that in control (3.9% compared with 17.9%, P = 0.049). Moreover, IRF-20 showed higher SF concentrations than control (P = 0.039). No effects of IRFs on anemia (P = 0.856), plasma Hb (P = 0.697), serum hepcidin (P = 0.311), and iron (P = 0.253) concentrations were observed. The assessed iron intakes were 22.2 mg/d in IRF-20 and 25.0 mg/d in IRF-40, respectively.
CONCLUSIONS


Antenatal IRFs reduce the risk of ID and IDA in late pregnancy, although the present results are inadequate to confirm an ideal dosage (No. ChiCTR1800017574).",2022,"No effects of IRFs on anemia (P = 0.856), plasma Hb (P = 0.697), serum hepcidin (P = 0.311), and iron (P = 0.253) levels were observed.","['All participants who completed the trial with full data (n = 170) were included in the analysis', 'Pregnant Women', ""240 pregnant women at 11-13 weeks' gestation without iron-deficiency anemia (IDA) in South China were recruited to this single-blind clinical trial [non-IDA referred to both hemoglobin (Hb)≥110g/L and serum ferritin (SF)≥15ng/mL""]","['IRFs containing 20 mg iron/day (IRF-20), or 3) IRFs containing 40 mg iron/day (IRF-40', 'iron-rich foods (IRFs', 'Antenatal Iron-Rich Food Intervention', 'IRFs']","['anemia (Hb<110g/L), iron deficiency (ID, definition1: SF<15ng/mL; definition2: SF<12ng/mL), and IDA (ID and Hb<110g/L', 'Iron-Deficiency Anemia', 'lower ID and IDA rates', 'plasma Hb and iron indices including SF, serum hepcidin, and iron', 'incidence in IRF-40', 'serum hepcidin', 'plasma Hb', 'risk of ID and IDA', 'iron intakes', 'iron status and biomarkers of iron metabolism', 'IRFs on anemia', 'incidence in IRF-20', 'Serum Hepcidin', 'SF levels']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}]","[{'cui': 'C0453836', 'cui_str': 'Iron-rich food'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0063613', 'cui_str': 'insulin resistance factor (uremia)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0063613', 'cui_str': 'insulin resistance factor (uremia)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0453836', 'cui_str': 'Iron-rich food'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",240.0,0.0897868,"No effects of IRFs on anemia (P = 0.856), plasma Hb (P = 0.697), serum hepcidin (P = 0.311), and iron (P = 0.253) levels were observed.","[{'ForeName': 'Suhua', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhaoxie', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhuohe', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': 'Maoming Maternal and Child Health Care Hospital, Maoming, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Maoming Maternal and Child Health Care Hospital, Maoming, China.'}, {'ForeName': 'Cuilan', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Maoming Maternal and Child Health Care Hospital, Maoming, China.'}, {'ForeName': 'Yanqi', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Maoming Maternal and Child Health Care Hospital, Maoming, China.'}, {'ForeName': 'Minli', 'Initials': 'M', 'LastName': 'Kong', 'Affiliation': 'Maoming Maternal and Child Health Care Hospital, Maoming, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yanna', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}]",The Journal of nutrition,['10.1093/jn/nxac065']
570,35285906,Supplemental Protein and a Multinutrient Beverage Speed Wound Healing after Acute Sleep Restriction in Healthy Adults.,"BACKGROUND


Physiologic and psychologic stress slow healing from experimental wounds by impairing immune function.
OBJECTIVES


We aimed to determine whether supplemental protein and multinutrient supplementation improved wound healing markers after acute stress induced by acute sleep restriction.
METHODS


In this single-blind, crossover study in generally healthy young adults (18 males/2 females; mean ± SD age: 19.7 ± 2.30 y), experimental wounds were created by removing the top layer of forearm blisters induced via suction after 48 h of 72-h sleep restriction (2-h nightly sleep), a protocol previously shown to delay wound healing. Skin barrier restoration (measured by transepidermal water loss) assessed wound healing ≤10 d postblistering, and local immune responses were evaluated by serial measurement of cytokine concentrations in fluid collected at wound sites for 48 h postblistering. Participants consumed controlled, isocaloric diets with either 0.900 g · kg-1 · d-1 protein plus placebo (PLA) or 1.50 g · kg-1 · d-1 protein plus multinutrient beverage [l-arginine: 20.0 g/d; l-glutamine: 30.0 g/d; omega-3 (n-3) fatty acids: 1.00 g/d; zinc sulfate: 24.0 mg/d; cholecalciferol: 800 IU/d; and vitamin C: 400 mg/d] (NUT) during sleep restriction and for 4 d afterwards.
RESULTS


Skin barrier restoration (primary outcome) was shorter for NUT (median: 3.98 d; IQR: 1.17 d) than for PLA (median: 5.25 d; IQR: 1.05 d) (P = 0.001). Cytokines from wound fluid (secondary outcome) increased over time (main effect of time P ≤ 0.001), except IL-13 (P = 0.07); however, no effects of treatment were observed.
CONCLUSIONS


Supplemental nutrition may promote wound healing after sleep restriction in healthy adults including military personnel, the latter of which also have a high incidence of wounds and infection.This trial was registered at clinicaltrials.gov as NCT03525184.",2022,"Cytokines from wound fluid (secondary outcome) increased over time (main effect of time P≤0.001), except IL-13 (P = 0.07); however, no effects of treatment were observed.
","['healthy adults including military personnel', 'generally healthy young adults (18 males/2 females; 19.7±2.30 years [mean±SD', 'Healthy Adults']","['supplemental protein and multi-nutrient supplementation', '0.900 g·kg-1·d-1 protein plus placebo (PLA) or 1.50 g·kg-1·d-1 protein plus multi-nutrient beverage (NUT; L-arginine: 20.0 g·d-1, L-glutamine: 30.0 g·d-1, omega-3 fatty acids: 1.00 g·d-1, zinc sulfate: 24.0 mg·d-1, cholecalciferol: 800 IU·d-1 and vitamin C', 'Supplemental Protein and a Multi-Nutrient Beverage', 'forearm blisters induced via suction after 48-h of 72-h sleep restriction (2-h nightly sleep']","['Skin barrier restoration (measured by trans-epidermal water loss, TEWL) assessed wound healing', 'wound healing markers', 'Skin barrier restoration']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.114432,"Cytokines from wound fluid (secondary outcome) increased over time (main effect of time P≤0.001), except IL-13 (P = 0.07); however, no effects of treatment were observed.
","[{'ForeName': 'Tracey J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Marques', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Whitney', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Fagnant', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Neumeier', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Heaton', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA, USA.'}, {'ForeName': 'Eunhan', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'School of Kinesiology, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Spielmann', 'Affiliation': 'School of Kinesiology, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Neil P', 'Initials': 'NP', 'LastName': 'Walsh', 'Affiliation': 'School of Sport and Exercise Sciences, Faculty of Science, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxac064']
571,35293030,"Safety and efficacy of apalutamide in Japanese patients with metastatic castration-sensitive prostate cancer receiving androgen deprivation therapy: Final report for the Japanese subpopulation analysis of the randomized, placebo-controlled, phase III TITAN study.","OBJECTIVES


The TITAN study is a randomized, double-blind, placebo-controlled, multinational trial that evaluated apalutamide with androgen deprivation therapy in patients with metastatic castration-sensitive prostate cancer. At the first interim analysis in the Japanese subpopulation (median follow-up 25.7 months), there was an improvement in overall survival and radiological progression-free survival with apalutamide versus placebo. Here, we report the final analysis results for the Japanese subpopulation.
METHODS


Patients were randomized 1:1 to receive apalutamide 240 mg or placebo. After the first interim analysis, protocol treatment was unblinded, and crossover was allowed. Efficacy and safety were evaluated in the preplanned, event-driven final analysis.
RESULTS


Fifty-one patients were Japanese (apalutamide n = 28; placebo n = 23). After a median follow-up of 46.0 months, the median overall survival was not reached neither in the apalutamide nor the placebo group; the hazard ratio was 0.45, favoring apalutamide, which was consistent with the overall population. Hazard ratios for time to cytotoxic chemotherapy (0.39), time to pain progression (0.87), and time to chronic opioid use (0.82) also favored apalutamide and were comparable with those of the overall population. Time to prostate-specific antigen progression and progression-free survival 2, respectively, was favored in the apalutamide group (0.21 and 0.44). Apalutamide was associated with higher incidences of rash and fracture in the Japanese subpopulation compared with the overall population.
CONCLUSIONS


The efficacy of apalutamide with androgen deprivation therapy in Japanese patients was consistent with efficacy demonstrated in the overall population. No new safety concerns emerged with long-term follow-up.",2022,"Apalutamide was associated with higher incidences of rash and fracture in the Japanese subpopulation compared with the overall population.
","['Patients', 'patients with metastatic castration-sensitive prostate cancer', 'Japanese patients', 'Fifty-one patients were Japanese (apalutamide n\u2009=\u200928; placebo n\u2009=\u200923', 'Japanese patients with metastatic castration-sensitive prostate cancer receiving']","['androgen deprivation therapy', 'placebo', 'apalutamide 240\u2009mg or placebo', 'apalutamide', 'apalutamide with androgen deprivation therapy', 'cytotoxic chemotherapy']","['hazard ratio', 'rash and fracture', 'Time to prostate-specific antigen progression and progression-free survival', 'median overall survival', 'overall survival and radiological progression-free survival', 'Efficacy and safety', 'time to chronic opioid use', 'time to pain progression', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",51.0,0.708034,"Apalutamide was associated with higher incidences of rash and fracture in the Japanese subpopulation compared with the overall population.
","[{'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology, Kindai University Hospital, Osakasayama, Osaka, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Arai', 'Affiliation': 'Department of Urology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Saitama, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Toho University Sakura Medical Center, Sakura, Chiba, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Aoyama', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Tomoyoshi', 'Initials': 'T', 'LastName': 'Hatayama', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Miku', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Lefresne', 'Affiliation': 'Janssen Research and Development, Los Angeles, California, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Janssen Research and Development US, Raritan, New Jersey, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Mundle', 'Affiliation': 'Janssen Research and Development US, Raritan, New Jersey, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Janssen Asia Pacific, Medical Affairs, Singapore.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer and Vancouver Prostate Centre, Vancouver, British Columbia, Canada.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14843']
572,35272093,Postpartum glucose intolerance following early gestational diabetes mellitus.,"BACKGROUND


Patients with gestational diabetes mellitus are at increased risk for type 2 diabetes mellitus or glucose intolerance postpartum compared with those without diabetes mellitus.
OBJECTIVE


We aimed to evaluate the association between early gestational diabetes mellitus and postpartum dysglycemia compared with gestational diabetes mellitus diagnosed by routine screening in a cohort of patients with obesity.
STUDY DESIGN


This was a secondary analysis of a randomized controlled trial of patients with obesity and singleton, nonanomalous gestations that compared early gestational diabetes mellitus screening at 14 to 20 weeks of gestation with routine screening at 24 to 28 weeks of gestation. Patients were included in this analysis if they were diagnosed with gestational diabetes mellitus at the primary study site. The primary outcome was postpartum dysglycemia, defined as any abnormality on 2-hour oral glucose tolerance test 6 weeks postpartum or clinical diagnosis based on hyperglycemia requiring pharmacotherapy after delivery with deferred glucose tolerance test. Maternal characteristics and outcomes were compared in bivariable analysis, and logistic regression estimated the association between early gestational diabetes mellitus and postpartum dysglycemia.
RESULTS


Of 119 patients included in this analysis, 30 were diagnosed by screening at <20 weeks of gestation and 89 at 24 to 28 weeks of gestation. Patients were overall similar in baseline characteristics. Patients with early gestational diabetes mellitus were more likely to have postpartum dysglycemia than those with gestational diabetes mellitus diagnosed with routine screening (36.7% vs 14.6%; odds ratio, 3.38; 95% confidence interval, 1.31-8.73). Most patients with early gestational diabetes mellitus who had postpartum dysglycemia were diagnosed clinically (n=7/11), whereas none of the patients with gestational diabetes mellitus established by routine testing were diagnosed with postpartum dysglycemia clinically. All (100%) patients with early gestational diabetes mellitus who completed a postpartum glucose tolerance test had dysglycemia compared with only 45% of patients with gestational diabetes mellitus diagnosed on routine screening. The proportion of patients who followed up for postpartum visits and the timing of follow-up were similar between groups. Postpartum glucose tolerance test completion was low but also similar between groups.
CONCLUSION


Although postpartum glucose tolerance test completion is low, patients with gestational diabetes mellitus before 20 weeks of gestation, seem to be at higher risk for postpartum dysglycemia than those with gestational diabetes mellitus diagnosed at routine screening in a cohort of patients with obesity. Larger studies are needed to confirm these findings, but postpartum follow-up and diabetes mellitus testing may be even more important to improve long-term health in patients with early gestational diabetes mellitus.",2022,"Postpartum glucose tolerance test completion was low but also similar between groups.
","['patients with obesity and singleton, non-anomalous gestations that compared early gestational diabetes screening at 14 to 20 weeks gestational age to routine screening at 24 to 28 weeks gestational age', 'Patients with early gestational diabetes', '119 patients included in this analysis, 30 were diagnosed by screening at <20 weeks gestation and 89 at 24-28 weeks gestation', 'Patients with gestational diabetes', 'patients with gestational diabetes', 'patients with early gestational diabetes who had postpartum dysglycemia', 'patients with obesity', 'early gestational diabetes', 'patients with early gestational diabetes', 'All (100%) patients with early gestational diabetes', 'Patients were included in this analysis if they were diagnosed with gestational diabetes at the primary study site']",[],"['postpartum dysglycemia', 'postpartum glucose tolerance test had dysglycemia', 'Postpartum glucose intolerance', 'postpartum dysglycemia, defined as any abnormality on 2-hour oral glucose tolerance test 6 weeks postpartum or clinical diagnosis based on hyperglycemia requiring pharmacotherapy after delivery with deferred glucose tolerance test', 'Postpartum glucose tolerance test completion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",[],"[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",119.0,0.151352,"Postpartum glucose tolerance test completion was low but also similar between groups.
","[{'ForeName': 'Macie L', 'Initials': 'ML', 'LastName': 'Champion', 'Affiliation': ""Center for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Women's Health, The University of Texas at Austin Dell Medical School, Austin, TX (Dr. Harper); Women's Services, Section of Maternal Fetal Medicine, Ochsner Health, New Orleans, LA (Dr. Biggio). Electronic address: mchampion@uabmc.edu.""}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Battarbee', 'Affiliation': ""Center for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Women's Health, The University of Texas at Austin Dell Medical School, Austin, TX (Dr. Harper); Women's Services, Section of Maternal Fetal Medicine, Ochsner Health, New Orleans, LA (Dr. Biggio).""}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Biggio', 'Affiliation': ""Center for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Women's Health, The University of Texas at Austin Dell Medical School, Austin, TX (Dr. Harper); Women's Services, Section of Maternal Fetal Medicine, Ochsner Health, New Orleans, LA (Dr. Biggio).""}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ""Center for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Women's Health, The University of Texas at Austin Dell Medical School, Austin, TX (Dr. Harper); Women's Services, Section of Maternal Fetal Medicine, Ochsner Health, New Orleans, LA (Dr. Biggio).""}, {'ForeName': 'Lorie M', 'Initials': 'LM', 'LastName': 'Harper', 'Affiliation': ""Center for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, AL (Drs. Champion, Battarbee, Casey); Department of Women's Health, The University of Texas at Austin Dell Medical School, Austin, TX (Dr. Harper); Women's Services, Section of Maternal Fetal Medicine, Ochsner Health, New Orleans, LA (Dr. Biggio).""}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100609']
573,35277436,Equity impact of participatory learning and action community mobilisation and mHealth interventions to prevent and control type 2 diabetes and intermediate hyperglycaemia in rural Bangladesh: analysis of a cluster randomised controlled trial.,"BACKGROUND


A cluster randomised trial of mHealth and participatory learning and action (PLA) community mobilisation interventions showed that PLA significantly reduced the prevalence of intermediate hyperglycaemia and type 2 diabetes mellitus (T2DM) and the incidence of T2DM among adults in rural Bangladesh; mHealth improved knowledge but showed no effect on glycaemic outcomes. We explore the equity of intervention reach and impact.
METHODS


Intervention reach and primary outcomes of intermediate hyperglycaemia and T2DM were assessed through interview surveys and blood fasting glucose and 2-hour oral glucose tolerance tests among population-based samples of adults aged ≥30 years. Age-stratified, gender-stratified and wealth-stratified intervention effects were estimated using random effects logistic regression.
RESULTS


PLA participants were similar to non-participants, though female participants were younger and more likely to be married than female non-participants. Differences including age, education, wealth and marital status were observed between individuals exposed and those not exposed to the mHealth intervention.PLA reduced the prevalence of T2DM and intermediate hyperglycaemia in all age, gender and wealth strata. Reductions in 2-year incidence of T2DM of at least 51% (0.49, 95% CI 0.26 to 0.92) were observed in all strata except among the oldest and least poor groups. mHealth impact on glycaemic outcomes was observed only among the youngest group, where a 47% reduction in the 2-year incidence of T2DM was observed (0.53, 95% CI 0.28 to 1.00).
CONCLUSION


Large impacts of PLA across all strata indicate a highly effective and equitable intervention. mHealth may be more suitable for targeting higher risk, younger populations.
TRIAL REGISTRATION NUMBER


ISRCTN41083256.",2022,"Differences including age, education, wealth and marital status were observed between individuals exposed and those not exposed to the mHealth intervention.","['control type 2 diabetes and intermediate hyperglycaemia in rural Bangladesh', 'among population-based samples of adults aged ≥30 years']","['participatory learning and action community mobilisation and mHealth interventions', 'mHealth and participatory learning and action (PLA) community mobilisation interventions', 'PLA']","['interview surveys and blood fasting glucose and 2-hour oral glucose tolerance tests', 'glycaemic outcomes', 'prevalence of T2DM and intermediate hyperglycaemia', 'age, education, wealth and marital status', '2-year incidence of T2DM', 'intermediate hyperglycaemia and T2DM']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0937031,"Differences including age, education, wealth and marital status were observed between individuals exposed and those not exposed to the mHealth intervention.","[{'ForeName': 'Malini', 'Initials': 'M', 'LastName': 'Pires', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Sanjit', 'Initials': 'S', 'LastName': 'Shaha', 'Affiliation': 'Centre for Health Research and Implementation, Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Department of Global Public Health, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Tasmin', 'Initials': 'T', 'LastName': 'Nahar', 'Affiliation': 'Centre for Health Research and Implementation, Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Centre for Health Research and Implementation, Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Hannah Maria', 'Initials': 'HM', 'LastName': 'Jennings', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kohenour', 'Initials': 'K', 'LastName': 'Akter', 'Affiliation': 'Centre for Health Research and Implementation, Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Haghparast-Bidgoli', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'A K Azad', 'Initials': 'AKA', 'LastName': 'Khan', 'Affiliation': 'Centre for Health Research and Implementation, Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Costello', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Kuddus', 'Affiliation': 'Centre for Health Research and Implementation, Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Kishwar', 'Initials': 'K', 'LastName': 'Azad', 'Affiliation': 'Centre for Health Research and Implementation, Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Fottrell', 'Affiliation': 'Institute for Global Health, University College London, London, UK e.fottrell@ucl.ac.uk.'}]",Journal of epidemiology and community health,['10.1136/jech-2021-217293']
574,35278356,"Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study.","BACKGROUND


Immunotherapies have shown clinical activity in patients with advanced biliary tract cancer, for which outcomes remain poor despite standard of care treatment with gemcitabine and cisplatin. We aimed to evaluate gemcitabine and cisplatin plus durvalumab with or without tremelimumab as first-line treatment in patients with advanced biliary tract cancer.
METHODS


This open-label, single-centre, phase 2 study was conducted at Seoul National University Hospital. Eligible patients were treatment-naïve adults aged 18 years or older with histologically proven unresectable or recurrent biliary tract cancer, at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (version 1.1), an Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of 12 weeks or longer, and adequate healthy organ and bone marrow function. Initially, all patients received one 3-week cycle of gemcitabine (1000 mg/m 2 ) and cisplatin (25 mg/m 2 ) on day 1 and 8 followed by gemcitabine and cisplatin plus durvalumab (1120 mg) and tremelimumab (75 mg) on day 1 of each cycle, starting with the second cycle (chemotherapy followed by chemotherapy plus durvalumab and tremelimumab group). Following protocol amendment, patients were recruited to receive gemcitabine and cisplatin plus durvalumab, starting on day 1 of the first cycle (chemotherapy plus durvalumab group) or gemcitabine and cisplatin plus durvalumab and tremelimumab also from day 1 of the first cycle (chemotherapy plus durvalumab and tremelimumab group) in parallel and allocated using a random block method. Assessors and patients were not masked to the treatment group. The primary endpoint was objective response rate, assessed in the efficacy population (ie, patients who were treated at least until the first tumour response assessment). This study is registered with ClinicalTrials.gov, NCT03046862 (active).
FINDINGS


Between March 2, 2017, and Feb 13, 2020, 128 patients were enrolled (32 in the chemotherapy followed by chemotherapy plus durvalumab and tremelimumab group, 49 in the chemotherapy plus durvalumab group, and 47 in the chemotherapy plus durvalumab and tremelimumab group). Four patients (two in the chemotherapy followed by chemotherapy plus durvalumab and tremelimumab group and two in the chemotherapy plus durvalumab group) were excluded and 124 were evaluable for tumour response. The median duration of follow-up was 48·2 months (IQR 41·5-49·4) for the chemotherapy followed by chemotherapy plus durvalumab and tremelimumab group, 26·6 months (19·0-27·9) for the chemotherapy plus durvalumab group, and 24·2 months (20·7-31·7) for the chemotherapy plus durvalumab and tremelimumab group. 82 (66%) of 124 patients achieved an objective response (15 [50%] of 30 in the chemotherapy followed by chemotherapy plus durvalumab and tremelimumab group, 34 [72%] of 47 in the chemotherapy plus durvalumab group, and 33 [70%] of 47 in the chemotherapy plus durvalumab and tremelimumab group). The most common grade 3 and 4 adverse events were decreased neutrophil count (67 [53%] of 126), anaemia (50 [40%]), and decreased platelet count (24 [19%]), with no unexpected safety events. No adverse events leading to discontinuation or death occurred.
INTERPRETATION


Gemcitabine and cisplatin plus immunotherapy showed promising efficacy and acceptable safety in patients with biliary tract cancer. Gemcitabine and cisplatin plus durvalumab are being evaluated in the phase 3, TOPAZ-1 study (NCT03875235) as first-line treatment in patients with advanced biliary tract cancer.
FUNDING


AstraZeneca; National Research Foundation of Korea (Grant No. 2021R1A2C2007430).",2022,"The most common grade 3 and 4 adverse events were decreased neutrophil count (67 [53%] of 126), anaemia (50 [40%]), and decreased platelet count (24 [19%]), with no unexpected safety events.","['Eligible patients were treatment-naïve adults aged 18 years or older with histologically proven unresectable or recurrent biliary tract cancer, at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (version 1.1), an Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of 12 weeks or longer, and adequate healthy organ and bone marrow function', 'patients with advanced biliary tract cancer', 'chemotherapy-naive patients with advanced biliary tract cancer', '128 patients were enrolled (32 in the chemotherapy followed by chemotherapy plus durvalumab and tremelimumab group, 49 in the chemotherapy plus durvalumab group, and 47 in the chemotherapy plus durvalumab and tremelimumab group', 'patients with biliary tract cancer']","['gemcitabine and cisplatin plus durvalumab with or without tremelimumab', 'gemcitabine and cisplatin', 'Gemcitabine and cisplatin plus durvalumab with or without tremelimumab', 'chemotherapy plus durvalumab and tremelimumab', 'chemotherapy plus durvalumab', 'gemcitabine and cisplatin plus durvalumab, starting on day 1 of the first cycle (chemotherapy plus durvalumab group) or gemcitabine and cisplatin plus durvalumab and tremelimumab also from day 1 of the first cycle (chemotherapy plus durvalumab and tremelimumab group) in parallel and allocated using a random block method', 'Gemcitabine and cisplatin plus immunotherapy', 'tremelimumab', 'gemcitabine', 'cisplatin', 'gemcitabine and cisplatin plus durvalumab', 'Gemcitabine and cisplatin plus durvalumab']","['platelet count', 'anaemia', 'neutrophil count', 'objective response rate', 'objective response', 'median duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",128.0,0.0280346,"The most common grade 3 and 4 adverse events were decreased neutrophil count (67 [53%] of 126), anaemia (50 [40%]), and decreased platelet count (24 [19%]), with no unexpected safety events.","[{'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Division of Medical Oncology, Seoul National University Hospital, Seoul, South Korea; Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea; Seoul National University Graduate School, Seoul, South Korea. Electronic address: ohdoyoun@snu.ac.kr.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Division of Medical Oncology, Seoul National University Hospital, Seoul, South Korea; Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dae-Won', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Division of Medical Oncology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jeesun', 'Initials': 'J', 'LastName': 'Yoon', 'Affiliation': 'Division of Medical Oncology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Tae-Yong', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Seoul National University Hospital, Seoul, South Korea; Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ju-Hee', 'Initials': 'JH', 'LastName': 'Bang', 'Affiliation': 'Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ah-Rong', 'Initials': 'AR', 'LastName': 'Nam', 'Affiliation': 'Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung-Seok', 'Initials': 'KS', 'LastName': 'Oh', 'Affiliation': 'Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea; Seoul National University Graduate School, Seoul, South Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Guthrie', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCoon', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Marlon C', 'Initials': 'MC', 'LastName': 'Rebelatto', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Jin Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Bundang Hospital, Seongnam, South Korea.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(22)00043-7']
575,35286146,Safety of Ceasing Aspirin Used Without a Clinical Indication After Age 70 Years: A Subgroup Analysis of the ASPREE Randomized Trial.,,2022,,['After Age 70 Years'],['Ceasing Aspirin'],[],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]",[],,0.138716,,"[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, and School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, and School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes & Clinical Research, Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minneapolis, and Division of Geriatrics, Department of Medicine, Hennepin County Medical Center and University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Berman Center for Outcomes & Clinical Research, Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, The University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, and Translational Immunology and Nanotechnology Research Program, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois.""}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stocks', 'Affiliation': 'Discipline of General Practice, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}]",Annals of internal medicine,['10.7326/M21-3823']
576,35287479,Fall arrest strategy training improves upper body response time compared to standard fall prevention exercise in older women: A randomized trial.,"INTRODUCTION


Exercise can decrease fall risk in older adults but less is known about training to reduce injury risk in the event a fall is unavoidable. The purpose of this study was to compare standard fall prevention exercises to novel Fall Arrest Strategy Training ( FAST ); exercises designed to improve upper body capacity to reduce fall-injury risk in older women.
METHOD


Forty women (mean age 74.5 years) participated in either Standard (n = 19) or  FAST  (n = 21) twice per week for 12 weeks. Both interventions included lower body strength, balance, walking practice, agility and education.  FAST  added exercises designed to enhance forward landing and descent control such as upper body strengthening, speed and practice of landing and descent on outstretched hands.
RESULTS


Both  FAST  and Standard significantly improved strength, mobility, balance, and fall risk factors from pre to post-intervention. There was a significant time by group interaction effect for upper body response time where  FAST  improved but Standard did not ( p  = 0.038).
DISCUSSION


FAST  resulted in similar gains in factors that reduce fall risk as a standard fall prevention program; with the additional benefit of improving speed of arm protective responses; a factor that may help enhance landing position and reduce injury risks such as head impact during a forward fall.",2022,"There was a significant time by group interaction effect for upper body response time where  FAST  improved but Standard did not ( p  = 0.038).
","['older adults', 'older women', 'Forty women (mean age 74.5 years) participated in either Standard (n\u2009=\u200919) or']","['standard fall prevention exercises to novel Fall Arrest Strategy Training ( FAST ); exercises', 'standard fall prevention exercise', 'Fall arrest strategy training', 'FAST']","['lower body strength, balance, walking practice, agility and education', 'strength, mobility, balance, and fall risk factors', 'upper body response time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0589105', 'cui_str': 'Strategy training'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0556927', 'cui_str': 'Walking practice'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",40.0,0.00319629,"There was a significant time by group interaction effect for upper body response time where  FAST  improved but Standard did not ( p  = 0.038).
","[{'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Arnold', 'Affiliation': 'School of Rehabilitation Science, 12371University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Lanovaz', 'Affiliation': '70396College of Kinesiology, 7235University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Farthing', 'Affiliation': '70396College of Kinesiology, 7235University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Legg', 'Affiliation': '70396College of Kinesiology, 7235University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Weimer', 'Affiliation': 'School of Rehabilitation Science, 12371University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'School of Rehabilitation Science, 12371University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}]",Clinical rehabilitation,['10.1177/02692155221087963']
577,35287788,Force Attenuation Properties of Padded Dance Support Socks.,"BACKGROUND


Foot injuries occur frequently in dancers, and researchers have investigated different protective measures to reduce their incidence. Research has primarily focused on ballet, but foot injuries also are common in modern and contemporary dance where footwear is not worn. While padded dance socks are a potential solution, the extent to which they provide force reduction for the feet is unknown.<br/> Purpose: This study investigates the extent to which padded dance support socks can reduce force on the foot during a dance sequence and when landing from a sauté jump.<br/> Methods: Twenty-one injury-free dancers (2 M, 19 F; age: 21.5 ± 6.7 years; height: 165.5 ± 6.1 cm; mass: 68.6 ± 15.0 kg) volunteered for this randomized, cross-over design study. Participants per- formed a 40-second modern dance sequence and a sauté jump landing under two conditions: wearing Apolla Performance Shock™ dance socks (DS) and with bare feet (BF). During these activities, 1.0 cm diameter circular force transducers were affixed under the first metatarsophalangeal joint and under the center of the heel. The sensors wirelessly recorded peak toe force, peak heel force, mean toe force, and mean heel force during dancing. A force platform measured vertical ground reaction force (VGRF) and time to peak VGRF, while the foot sensors measured peak toe force and peak heel force, during the jump landings. A Noraxon MR3.12 biomechanics system synchronized and recorded the data. All force data were normalized to body weight (BW). Dependent samples t-tests were used to assess pairwise differences in these measures between the DS and BF conditions. Alpha was set at p < 0.05.<br/> Results: Mean and peak heel forces/BW when dancing with DS were significantly lower than during BF dancing (mean: p = 0.015; peak: p = 0.0004). Peak VGRF/BW when landing from the sauté jump with DS was significantly lower compared with landing in BF (p = 0.035). All other variables were not significantly different between conditions, but all DS force values were lower than BF.<br/> Conclusions: We offer evidence that padded dance socks may reduce foot forces dancers commonly encounter during modern dance. The trends we recorded require further study to assess the extent to which the socks exhibit beneficial effects when considering both the many hours dancers train and the cumulative effects of impacts sustained by their feet.",2022,when landing from the sauté jump with DS was significantly lower compared with landing in BF (p = 0.035).,"['Twenty-one injury-free dancers (2 M, 19 F; age: 21.5 ± 6.7 years; height: 165.5 ± 6.1 cm; mass: 68.6 ± 15.0 kg) volunteered for this randomized, cross-over design study']","['sauté jump landing under two conditions: wearing Apolla Performance Shock™ dance socks (DS) and with bare feet (BF', 'padded dance support socks']","['body weight (BW', 'peak toe force, peak heel force, mean toe force, and mean heel force', 'Mean and peak heel forces/BW', 'Peak VGRF/BW', 'vertical ground reaction force (VGRF) and time to peak VGRF', 'DS force values']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.100456,when landing from the sauté jump with DS was significantly lower compared with landing in BF (p = 0.035).,"[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Russell', 'Affiliation': 'Laboratory for Science and Health in Artistic Performance, School of Applied Health Sciences and Wellness, Ohio University, Athens, Ohio, USA;, Email: jeff.russell@ohio.edu.'}, {'ForeName': 'Isabella F', 'Initials': 'IF', 'LastName': 'Mueller', 'Affiliation': 'Doctor of Physical Therapy Program, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, New York, USA.'}]",Journal of dance medicine & science : official publication of the International Association for Dance Medicine & Science,['10.12678/1089-313X.061522c']
578,35293364,Feasibility and Pilot Testing of Mobile Health Apps to Supplement 2 Healthy Lifestyle Interventions in Chronic Traumatic Brain Injury.,"OBJECTIVES


To determine the feasibility of mobile health (mHealth) apps for enhancing participation of people with chronic traumatic brain injury (TBI) in the Group Lifestyle Balance (GLB-TBI) weight loss intervention and Brain Health Group (BHG-TBI) active control intervention.
SETTING


Community.
PARTICIPANTS


n = 56 overweight/obese adults with moderate-severe TBI.
DESIGN


The GLB-TBI is a 12-month group- and community-based program to promote healthy eating and physical activity. The BHG-TBI is a 12-month group- and community-based program to promote general brain health, designed as an active control condition matched on time, structure, and perceived benefit to the GLB-TBI. In a randomized controlled trial testing the efficacy of the GLB-TBI for weight loss, participants used a group-specific mHealth app providing daily tips customized according to their intervention allocation.
MAIN MEASURES


Compliance (percentage of daily prompts read and completed) and participant-reported satisfaction and usability.
RESULTS


In conjunction with relevant stakeholders, we developed the content and structure of the GLB-TBI and BHG-TBI apps based on core curriculum components. We incorporated cognitive strategies (app notifications) to address potential cognitive impairment common after TBI. Both apps delivered brief daily educational and motivational ""tips"" derived directly from their respective curricula. Daily use of the apps varied greatly across participants, with most participants who used the apps completing 10% to 50% of daily content. Participants found the apps to be easy to use, but only some found them helpful. App use was substantially different for those who participated in the intervention during (2020) versus before (2019) the COVID-19 pandemic.
CONCLUSIONS


Although enhancing an intensive lifestyle intervention with mHealth technology may be helpful, further refinement is needed to optimize the frequency and delivery methods of mHealth content. Although one might expect remote app use to have been higher during the pandemic, we observed the opposite, potentially due to less hands-on training and ongoing support to use the app and/or general technology fatigue with social distancing.",2022,"App use was substantially different for those who participated in the intervention during (2020) versus before (2019) the COVID-19 pandemic.
","['n = 56 overweight/obese adults with moderate-severe TBI', 'Community', 'Chronic Traumatic Brain Injury', 'people with chronic traumatic brain injury (TBI']","['mobile health (mHealth) apps', 'Mobile Health Apps to Supplement 2 Healthy Lifestyle Interventions', 'GLB-TBI', 'Lifestyle Balance (GLB-TBI) weight loss intervention and Brain Health Group (BHG-TBI) active control intervention']",['Compliance (percentage of daily prompts read and completed) and participant-reported satisfaction and usability'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",56.0,0.0301271,"App use was substantially different for those who participated in the intervention during (2020) versus before (2019) the COVID-19 pandemic.
","[{'ForeName': 'Shannon B', 'Initials': 'SB', 'LastName': 'Juengst', 'Affiliation': 'Departments of Physical Medicine & Rehabilitation (Drs Juengst and Messrs Conley and Luu) and Applied Clinical Research (Dr Juengst), University of Texas Southwestern Medical Center, Dallas; North Texas Traumatic Brain Injury Model System, Dallas, Texas (Drs Juengst and Driver and Ms McShan); and Baylor Scott and White Research Institute, Dallas, and Baylor Scott & White Institute for Rehabilitation, Dallas, Texas (Ms McShan and Dr Driver).'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'McShan', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Conley', 'Affiliation': ''}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Luu', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Driver', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000769']
579,35294537,Efficacy of Losartan in Hospitalized Patients With COVID-19-Induced Lung Injury: A Randomized Clinical Trial.,"Importance


SARS-CoV-2 viral entry may disrupt angiotensin II (AII) homeostasis, contributing to COVID-19 induced lung injury. AII type 1 receptor blockade mitigates lung injury in preclinical models, although data in humans with COVID-19 remain mixed.
Objective


To test the efficacy of losartan to reduce lung injury in hospitalized patients with COVID-19.
Design, Setting, and Participants


This blinded, placebo-controlled randomized clinical trial was conducted in 13 hospitals in the United States from April 2020 to February 2021. Hospitalized patients with COVID-19 and a respiratory sequential organ failure assessment score of at least 1 and not already using a renin-angiotensin-aldosterone system (RAAS) inhibitor were eligible for participation. Data were analyzed from April 19 to August 24, 2021.
Interventions


Losartan 50 mg orally twice daily vs equivalent placebo for 10 days or until hospital discharge.
Main Outcomes and Measures


The primary outcome was the imputed arterial partial pressure of oxygen to fraction of inspired oxygen (Pao2:Fio2) ratio at 7 days. Secondary outcomes included ordinal COVID-19 severity; days without supplemental o2, ventilation, or vasopressors; and mortality. Losartan pharmacokinetics and RAAS components (AII, angiotensin-[1-7] and angiotensin-converting enzymes 1 and 2)] were measured in a subgroup of participants.
Results


A total of 205 participants (mean [SD] age, 55.2 [15.7] years; 123 [60.0%] men) were randomized, with 101 participants assigned to losartan and 104 participants assigned to placebo. Compared with placebo, losartan did not significantly affect Pao2:Fio2 ratio at 7 days (difference, -24.8 [95%, -55.6 to 6.1]; P = .12). Compared with placebo, losartan did not improve any secondary clinical outcomes and led to fewer vasopressor-free days than placebo (median [IQR], 9.4 [9.1-9.8] vasopressor-free days vs 8.7 [8.2-9.3] vasopressor-free days).
Conclusions and Relevance


This randomized clinical trial found that initiation of orally administered losartan to hospitalized patients with COVID-19 and acute lung injury did not improve Pao2:Fio2 ratio at 7 days. These data may have implications for ongoing clinical trials.
Trial Registration


ClinicalTrials.gov Identifier: NCT04312009.",2022,"Compared with placebo, losartan did not improve any secondary clinical outcomes and led to fewer vasopressor-free days than placebo (median [IQR], 9.4 [9.1-9.8] vasopressor-free days vs 8.7 [8.2-9.3] vasopressor-free days).
","['Hospitalized patients with COVID-19 and a respiratory sequential organ failure assessment score of at least 1 and not already using a renin-angiotensin-aldosterone system ', '13 hospitals in the United States from April 2020 to February 2021', '205 participants (mean [SD] age, 55.2 [15.7] years; 123 [60.0%] men', 'hospitalized patients with COVID-19', 'hospitalized patients with COVID-19 and acute lung injury', 'Hospitalized Patients With COVID-19-Induced Lung Injury']","['Losartan', 'placebo', 'Losartan 50 mg orally twice daily vs equivalent placebo', 'losartan', 'placebo, losartan']","['Pao2:Fio2 ratio', 'ordinal COVID-19 severity; days without supplemental o2, ventilation, or vasopressors; and mortality', 'imputed arterial partial pressure of oxygen to fraction of inspired oxygen (Pao2:Fio2) ratio']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",205.0,0.834835,"Compared with placebo, losartan did not improve any secondary clinical outcomes and led to fewer vasopressor-free days than placebo (median [IQR], 9.4 [9.1-9.8] vasopressor-free days vs 8.7 [8.2-9.3] vasopressor-free days).
","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Puskarich', 'Affiliation': 'Department of Emergency Medicine, University of Minnesota, Minneapolis.'}, {'ForeName': 'Nicholas E', 'Initials': 'NE', 'LastName': 'Ingraham', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, University of Minnesota, Minneapolis.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Merck', 'Affiliation': 'Department of Emergency Medicine, University of Florida College of Medicine, Gainesville.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wacker', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, University of Minnesota, Minneapolis.'}, {'ForeName': 'Lauren Page', 'Initials': 'LP', 'LastName': 'Black', 'Affiliation': 'Department of Emergency Medicine, University of Florida College of Medicine, Jacksonville.'}, {'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Jones', 'Affiliation': 'Department of Emergency Medicine, University of Mississippi Medical Center, Jackson.'}, {'ForeName': 'Courtney V', 'Initials': 'CV', 'LastName': 'Fletcher', 'Affiliation': 'Center for Drug Discovery, University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'South', 'Affiliation': ""Section of Nephrology, Department of Pediatrics, Wake Forest School of Medicine and Brenner Children's Hospital, Winston Salem, North Carolina.""}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Murray', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lewandowski', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Hospital, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Farhat', 'Affiliation': 'Department of Surgery, North Memorial Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Benoit', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Biros', 'Affiliation': 'Department of Emergency Medicine, University of Minnesota, Minneapolis.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Cherabuddi', 'Affiliation': 'Department of Emergency Medicine, University of Florida College of Medicine, Gainesville.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Chipman', 'Affiliation': 'Department of Surgery, University of Minnesota, Minneapolis.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Schacker', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, University of Minnesota, Minneapolis.'}, {'ForeName': 'Faheem W', 'Initials': 'FW', 'LastName': 'Guirgis', 'Affiliation': 'Department of Emergency Medicine, University of Florida College of Medicine, Jacksonville.'}, {'ForeName': 'Helen T', 'Initials': 'HT', 'LastName': 'Voelker', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Tignanelli', 'Affiliation': 'Department of Surgery, University of Minnesota, Minneapolis.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2022.2735']
580,35298893,Once-only colonoscopy or two rounds of faecal immunochemical testing 2 years apart for colorectal cancer screening (SCREESCO): preliminary report of a randomised controlled trial.,"BACKGROUND


Screening for colorectal cancer is done with lower gastrointestinal endoscopy or stool-based tests. There is little evidence from randomised trials to show primary colonoscopy reduces mortality in colorectal cancer. We aimed to investigate the effect of screening with once-only colonoscopy or two rounds of faecal immunochemical test screening on colorectal cancer mortality and incidence.
METHODS


We did a randomised controlled trial in Sweden (SCREESCO). Residents in 18 of 21 regions who were age 60 years in the year of randomisation were identified from a population register maintained by the Swedish Tax Agency. A statistician with no further involvement in the trial used a randomised block method to assign individuals to once-only colonoscopy, two rounds of faecal immunochemical testing (OC-Sensor; 2 years apart), or a control group (no intervention; standard diagnostic pathways), in a ratio of 1:6 for colonoscopy versus control and 1:2 for faecal immunochemical testing versus control. Masking was not possible due to the nature of the trial. The primary endpoints of the trial are colorectal cancer mortality and colorectal cancer incidence. Here, we report preliminary participation rates, baseline findings, and adverse events from March, 2014, to December, 2020, in the two intervention groups after completion of recruitment and screening, up to the completion of the second faecal immunochemical testing round. Analyses were done in the intention-to-screen population, defined as all individuals who were randomly assigned to the respective study group. This study is registered with ClinicalTrials.gov, NCT02078804.
FINDINGS


Between March 1, 2014, and Dec 31, 2020, 278 280 people were included in the study; 31 140 were assigned to the colonoscopy group, 60 300 to the faecal immunochemical test group, and 186 840 to the control group. 10 679 (35·1%) of 30 400 people who received an invitation for colonoscopy participated. 33 383 (55·5%) of 60 137 people who received a postal faecal immunochemical test participated. In the intention-to-screen analysis, colorectal cancer was detected in 49 (0·16%) of 31 140 people in the colonoscopy group versus 121 (0·20%) of 60 300 in the faecal immunochemical test group (relative risk [RR] 0·78, 95% CI 0·56-1·09). Advanced adenomas were detected in 637 (2·05%) people in the colonoscopy group and 968 (1·61%) in the faecal immunochemical test group (RR 1·27, 95% CI 1·15-1·41). Colonoscopy detected more right-sided advanced adenomas than faecal immunochemical testing. There were two perforations and 15 major bleeds in 16 555 colonoscopies. No intervention-related deaths occurred.
INTERPRETATION


The diagnostic yield and the low number of adverse events indicate that the design from this trial, both for once-only colonoscopy and faecal immunochemical test screening, could be transferred to a population-based screening service if a benefit in disease-specific mortality is subsequently shown.
FUNDING


Swedish regions, County Council, Regional Cancer Center Mellansverige, Swedish Cancer Society, Aleris Research and Development Fund, Eiken Chemical.",2022,There were two perforations and 15 major bleeds in 16 555 colonoscopies.,"['Residents in 18 of 21 regions who were age 60 years in the year of randomisation were identified from a population register maintained by the Swedish Tax Agency', 'Between March 1, 2014, and Dec 31, 2020, 278\u2009280 people were included in the study', '33\u2009383 (55·5%) of 60\u2009137 people who received a postal faecal immunochemical test participated', '10\u2009679 (35·1%) of 30\u2009400 people who received an invitation for colonoscopy participated', ' 31 140 were assigned to the colonoscopy group, 60\u2009300 to the faecal immunochemical test group, and 186\u2009840 to the control group']","['screening with once-only colonoscopy or two rounds of faecal immunochemical test screening', 'control group (no intervention; standard diagnostic pathways), in a ratio of 1:6 for colonoscopy versus control and 1:2 for faecal immunochemical testing versus control', 'faecal immunochemical testing 2 years apart for colorectal cancer screening']","['colorectal cancer mortality and incidence', 'colorectal cancer mortality and colorectal cancer incidence', 'Advanced adenomas', 'colorectal cancer']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0032681', 'cui_str': 'Population Register'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0039371', 'cui_str': 'Tax'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",278280.0,0.303506,There were two perforations and 15 major bleeds in 16 555 colonoscopies.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsberg', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. Electronic address: anna.forsberg@ki.se.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Westerberg', 'Affiliation': 'Department of Mathematics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Steele', 'Affiliation': 'Department of Surgery, Population Health and Genomics, School of Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Blom', 'Affiliation': 'Department of Surgery and Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Engstrand', 'Affiliation': 'Department of Microbiology and Department of Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Fritzell', 'Affiliation': 'Department of Neurobiology and Department of Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'Department of Radiology, Institute of Clinical Sciences at Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden; Department of Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lars-Åke', 'Initials': 'LÅ', 'LastName': 'Levin', 'Affiliation': 'Department of Health, Medicine, and Caring Sciences, Linköping University Linköping, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Löwbeer', 'Affiliation': 'Department of Laboratory Medicine, Division of Clinical Chemistry, Karolinska Institutet, Stockholm, Sweden; Department of Clinical Chemistry, SYNLAB Medilab, Täby, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pischel', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Strömberg', 'Affiliation': 'School of Public Health, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Törnberg', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology and Department of Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden; Karolinska Comprehensive Cancer Center, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ekbom', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holmberg', 'Affiliation': ""Department of Surgical Sciences, Uppsala University, Uppsala, Sweden; Translational Oncology & Urology Research (TOUR), School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Hultcrantz', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(21)00473-8']
581,35279718,Estradiol Valerate vs Ethinylestradiol in Combined Oral Contraceptives: Effects on the Pituitary-Ovarian Axis.,"CONTEXT


Limited studies have compared the effects of combined oral contraceptives (COCs) containing natural estrogens and synthetic ethinylestradiol (EE) on reproductive hormones.
OBJECTIVE


To compare estradiol valerate (EV) + dienogest (DNG), EE + DNG, and DNG alone (active control) on levels of follicle stimulating hormone (FSH), luteinizing hormone, anti-Müllerian hormone (AMH), ovarian steroids, sex hormone binding globulin (SHBG), and the free androgen index (FAI).
METHODS


This spin-off study from a randomized trial enrolled 59 healthy, 18 to 35-year-old ovulatory women, outpatients at Helsinki and Oulu University Hospitals, Finland, who were randomized to EV 2 mg + DNG 2-3 mg (n = 20); EE 0.03 mg + DNG 2 mg (n = 20); and DNG 2 mg (n = 19) for 9 weeks. Blood samples were drawn at baseline, and at 5 and 9 weeks. Age and BMI were comparable between groups; 3 women discontinued.
RESULTS


EV + DNG suppressed FSH by -27% (-51% to -3%) (median [95% CI]) vs EE + DNG, -64% (-78 to -51), P = 0.04, but AMH levels decreased similarly by -9% (-18 to -0.1) vs -13% (-28 to 0.2), P = 0.38, respectively. EV + DNG increased SHBG levels by 56% (30% to 82%) and EE + DNG by 385% (313% to 423%), P < 0.001. Total testosterone decreased by 16% (-27% to -5%) in the EV + DNG group but it did not decrease in the EE + DNG group, whereas the FAI decreased by -39% (-54% to -25%) vs -72% (-78% to -67%), P < 0.001. DNG alone did not induce changes in any of these parameters.
CONCLUSION


Compared with EE + DNG, treatment with EV + DNG resulted in milder pituitary downregulation and reduced induction of hepatic SHBG synthesis-potentially carrying more beneficial health effects.",2022,"DNG alone did not induce changes in any of these parameters.
","['Outpatient setting at Helsinki and Oulu University Hospitals, Finland', '59 healthy, 18-35-year-old ovulatory women were enrolled']","['estradiol valerate (EV)+dienogest (DNG), EE+DNG, and DNG alone (an active control', 'Combined Oral Contraceptives', 'combined oral contraceptives (COCs) containing natural estrogens and synthetic ethinylestradiol (EE', 'EV+DNG', 'Estradiol Valerate Vs', 'Ethinylestradiol']","['AMH levels', 'FSH', 'milder pituitary downregulation and reduced induction of hepatic SHBG synthesis', 'FAI', 'Total testosterone (T', 'levels of follicle stimulating hormone (FSH), luteinizing hormone, Anti-Müllerian hormone (AMH), ovarian steroids, sex hormone binding globulin (SHBG), and the Free Androgen Index (FAI', 'SHBG levels']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}]","[{'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0418984', 'cui_str': 'Pituitary downregulation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}]",59.0,0.193822,"DNG alone did not induce changes in any of these parameters.
","[{'ForeName': 'Annina', 'Initials': 'A', 'LastName': 'Haverinen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029 Helsinki, Finland.'}, {'ForeName': 'Kaisu', 'Initials': 'K', 'LastName': 'Luiro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029 Helsinki, Finland.'}, {'ForeName': 'Marika H', 'Initials': 'MH', 'LastName': 'Kangasniemi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oulu, Oulu University Hospital and Medical Research Centre PEDEGO Research Unit, PO Box 5000, 90014 Oulu, Finland.'}, {'ForeName': 'Terhi T', 'Initials': 'TT', 'LastName': 'Piltonen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oulu, Oulu University Hospital and Medical Research Centre PEDEGO Research Unit, PO Box 5000, 90014 Oulu, Finland.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Hustad', 'Affiliation': 'Department of Clinical Science and Core Facility for Metabolomics, University of Bergen, NO-5020 Bergen, Norway.'}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029 Helsinki, Finland.'}, {'ForeName': 'Juha S', 'Initials': 'JS', 'LastName': 'Tapanainen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029 Helsinki, Finland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac150']
582,35287231,Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab.,"INTRODUCTION


Consensus definitions for clinical remission and super-response were recently established for severe asthma. Benralizumab is an interleukin-5 (IL-5) receptor α-directed monoclonal antibody for severe, uncontrolled asthma; efficacy and safety were demonstrated in previous pivotal phase 3 trials (SIROCCO, CALIMA, ZONDA). This analysis applied a composite remission definition to characterize individual responses to benralizumab after 6 and 12 months.
METHODS


In previous phase 3 studies, eligible patients were those with severe, uncontrolled asthma receiving medium- or high-dosage inhaled corticosteroids plus long-acting β 2 -agonists. This post hoc analysis included patients randomized to the approved benralizumab dose and not receiving oral corticosteroids (OCS) at baseline (SIROCCO/CALIMA) or OCS ≤ 12.5 mg per day (ZONDA). Individual remission components were zero exacerbations; zero OCS use; Asthma Control Questionnaire-6 (ACQ-6) score < 1.5 or ≤ 0.75; and pre-bronchodilator forced expiratory volume in 1 s (FEV 1 ) increase ≥ 100 mL; clinical remission incorporated zero exacerbations, zero OCS use, ACQ-6 score ≤ 0.75, and pre-bronchodilator FEV 1  increase ≥ 100 mL after 6 or 12 months.
RESULTS


Overall, 609 patients (N = 301 and N = 308) and 586 patients (N = 293 and N = 293) receiving benralizumab in SIROCCO and CALIMA were included at 6 and 12 months, respectively; 40 ZONDA patients were included after 6 months. In SIROCCO/CALIMA, similar to 6-month findings,  approx. 83% and approx. 49% receiving benralizumab, and 77% and 37% on placebo achieved ≥ 2 and ≥ 3 remission components after 12 months; 14.5% (85/586) on benralizumab and 7.7% (48/620) on placebo achieved clinical remission at 12 months. Among ZONDA patients, 75% and approx. 48% on benralizumab and 35% and 20% on placebo achieved ≥ 2 and ≥ 3 remission components at 6 months, respectively; 22.5% (9/40) on benralizumab and 7.5% on placebo achieved clinical remission.
CONCLUSIONS


This analysis demonstrates clinical remission is achievable by targeting the underlying drivers of inflammation. Precision medicines can help shift treatment paradigms toward treat-to-target, with clinical remission as the ultimate therapeutic goal in severe asthma.
CLINICAL TRIAL REGISTRATION


SIROCCO (NCT01928771); CALIMA (NCT01914757); ZONDA (NCT02075255).",2022,Individual remission components were zero exacerbations; zero OCS use; Asthma Control Questionnaire-6 (ACQ-6) score < 1.5 or ≤ 0.75; and pre-bronchodilator forced expiratory volume in 1 s (FEV 1 ) increase ≥ ,"['eligible patients were those with severe, uncontrolled asthma receiving medium- or high-dosage inhaled corticosteroids plus long-acting', '609 patients (N\u2009=\u2009301 and N\u2009=\u2009308) and 586 patients (N\u2009=\u2009293 and N\u2009=\u2009293) receiving benralizumab in SIROCCO and CALIMA were included at 6 and 12\xa0months, respectively; 40 ZONDA patients were included after 6\xa0months', 'Severe Asthma']","['placebo', 'Benralizumab', 'benralizumab', 'ZONDA', 'benralizumab dose and not receiving oral corticosteroids (OCS) at baseline (SIROCCO/CALIMA) or OCS\u2009≤\u200912.5\xa0mg per day (ZONDA']","['pre-bronchodilator forced expiratory volume in 1\xa0s (FEV 1 ) increase ≥', 'clinical remission', 'zero exacerbations, zero OCS use, ACQ-6 score\u2009≤\u20090.75, and pre-bronchodilator FEV 1  increase ≥', '≥\u20092 and ≥\u20093 remission components']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0860909', 'cui_str': 'FEV 1 increased'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",609.0,0.200122,Individual remission components were zero exacerbations; zero OCS use; Asthma Control Questionnaire-6 (ACQ-6) score < 1.5 or ≤ 0.75; and pre-bronchodilator forced expiratory volume in 1 s (FEV 1 ) increase ≥ ,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Menzies-Gow', 'Affiliation': 'Department of Respiratory Medicine, Royal Brompton Hospital, Sydney St, London, SW3 6NP, UK. a.menzies-gow@rbht.nhs.uk.'}, {'ForeName': 'Flavia L', 'Initials': 'FL', 'LastName': 'Hoyte', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Price', 'Affiliation': 'Observational and Pragmatic Research Institute, Midview City, Singapore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barker', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kreindler', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jison', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Brooks', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Papeleu', 'Affiliation': 'AstraZeneca, Groot-Bijgaarden, Belgium.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Katial', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.'}]",Advances in therapy,['10.1007/s12325-022-02098-1']
583,35288954,The impact of an occupational therapy group cognitive rehabilitation program for people with dementia.,"INTRODUCTION


This study was conducted to examine the impact of a group cognitive rehabilitation program for people with dementia on everyday memory function and quality of life.
METHODS


Participants included in the study were community-dwelling adults with a diagnosis of dementia. The intervention was a 5-week occupational therapy lead group cognitive rehabilitation program delivered once a week for 1.5 h. Outcome measures included standardised memory tests, subjective everyday memory function and quality of life ratings. The measures were completed at baseline, post-intervention and 3-month post-intervention.
RESULTS


Outcome measures were completed with 58 participants. Statistically significant improvements in standardised memory scores were noted following the intervention. Similarly, self-rated everyday memory function and quality of life scores significantly improved following the intervention. All standardised scores and subjective ratings were maintained at 3-month follow-up.
CONCLUSION


Group-based cognitive rehabilitation programs can positively impact the quality of life and everyday memory function among people with dementia.",2022,"Similarly, self-rated everyday memory function and quality of life scores significantly improved following the intervention.","['people with dementia on everyday memory function and quality of life', 'Participants included in the study were community-dwelling adults with a diagnosis of dementia', 'people with dementia']","['cognitive rehabilitation program', 'occupational therapy lead group cognitive rehabilitation program', 'Group-based cognitive rehabilitation programs', 'occupational therapy group cognitive rehabilitation program']","['self-rated everyday memory function and quality of life scores', 'standardised memory tests, subjective everyday memory function and quality of life ratings', 'standardised memory scores', 'quality of life and everyday memory function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",,0.00699081,"Similarly, self-rated everyday memory function and quality of life scores significantly improved following the intervention.","[{'ForeName': 'Aislinn', 'Initials': 'A', 'LastName': 'Griffin', 'Affiliation': ""Medicine for the Elderly Department, St. James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'O Gorman', 'Affiliation': ""Medicine for the Elderly Department, St. James's Hospital, Dublin, Ireland.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': ""Medicine for the Elderly Department, St. James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Gibb', 'Affiliation': ""Dementia Services Information and Development Centre, St. James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Tadhg', 'Initials': 'T', 'LastName': 'Stapleton', 'Affiliation': 'Discipline of Occupational Therapy, School of Medicine, Trinity College, Dublin, Ireland.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12795']
584,35293031,"TRPM8 agonist (cryosim-1) gel for scalp itch: a randomised, vehicle-controlled clinical trial.",,2022,,[],['TRPM8 agonist (cryosim-1) gel'],[],[],"[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.396383,,"[{'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Korea.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Computer Science and Engineering, Kwangwoon University, Seoul, Korea.'}, {'ForeName': 'E T', 'Initials': 'ET', 'LastName': 'Wei', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Selescu', 'Affiliation': 'Department of Anatomy, Physiology and Biophysics, Faculty of Biology, University of Bucharest, Bucuresti, Romania.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Korea.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Korea.'}, {'ForeName': 'B Y', 'Initials': 'BY', 'LastName': 'Chung', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Korea.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Korea.'}, {'ForeName': 'H O', 'Initials': 'HO', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Korea.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.18080']
585,35296912,"Effects of TS-142, a novel dual orexin receptor antagonist, on sleep in patients with insomnia: a randomized, double-blind, placebo-controlled phase 2 study.","RATIONALE


Novel compound with potent antagonistic activity against orexin receptors may be new treatment option for patients with insomnia.
OBJECTIVE


The aim was to investigate the efficacy and safety of single oral doses of the dual orexin receptor antagonist TS-142 in patients with insomnia.
METHODS


This multicenter, double-blind, crossover randomized clinical trial included non-elderly patients with insomnia. Patients were randomized to receive single doses of placebo and TS-142 at doses of 5, 10, and 30 mg in one of four different sequences, with a 7-day washout period between treatments. Primary efficacy endpoints were latency to persistent sleep (LPS) and wake time after sleep onset (WASO) measured by polysomnography.
RESULTS


Twenty-four patients were included (mean age 50.3 ± 10.5 years; mean duration of insomnia 5.71 ± 8.68 years). Least-squares mean differences (95% confidence interval) from placebo in LPS with 5, 10, and 30 mg TS-142 were - 42.38 (- 60.13, - 24.63), - 42.10 (- 60.02, - 24.17), and - 44.68 (- 62.41, - 26.95) minutes, respectively (all p < 0.001). Least-squares mean differences (95% confidence interval) from placebo in WASO with 5, 10, and 30 mg TS-142 were - 27.52 (- 46.90, - 8.14), - 35.44 (- 55.02, - 15.87), and - 54.69 (- 74.16, - 35.23) minutes, respectively (all p < 0.01). Self-reported aspects of sleep initiation and sleep quality, determined using the Leeds Sleep Evaluation Questionnaire (LSEQ), were also improved with TS-142 administration versus placebo. TS-142 was well tolerated; all adverse events were mild or moderate and none were serious.
CONCLUSION


Single-dose TS-142 was well tolerated and had clinically relevant effects on objective and subjective sleep parameters in patients with insomnia.
CLINICAL TRIAL REGISTRATION


JapicCTI173570 (www.
CLINICALTRIALS


jp); NCT04573725 (www.
CLINICALTRIALS


gov).",2022,"CONCLUSION


Single-dose TS-142 was well tolerated and had clinically relevant effects on objective and subjective sleep parameters in patients with insomnia.
","['Twenty-four patients were included (mean age 50.3\u2009±\u200910.5\xa0years; mean duration of insomnia 5.71\u2009±\u20098.68\xa0years', 'patients with insomnia', 'non-elderly patients with insomnia']","['placebo', 'dual orexin receptor antagonist TS-142', 'placebo and TS-142', 'placebo. TS-142', 'TS-142']","['tolerated; all adverse events', 'Leeds Sleep Evaluation Questionnaire (LSEQ', 'sleep initiation and sleep quality', 'objective and subjective sleep parameters', 'efficacy and safety', 'latency to persistent sleep (LPS) and wake time after sleep onset (WASO) measured by polysomnography']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]",24.0,0.413399,"CONCLUSION


Single-dose TS-142 was well tolerated and had clinically relevant effects on objective and subjective sleep parameters in patients with insomnia.
","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Psychiatry, Nihon University School of Medicine, 30-1 Oyaguchi-kamicho, Itabashi, Tokyo, 173-8610, Japan. maco.uchiyama@nifty.com.'}, {'ForeName': 'Daiji', 'Initials': 'D', 'LastName': 'Kambe', 'Affiliation': 'Development Headquarters, Taisho Pharmaceutical Co., Ltd, 3-24-1 Takada, Toshima, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Imadera', 'Affiliation': 'Development Headquarters, Taisho Pharmaceutical Co., Ltd, 3-24-1 Takada, Toshima, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kajiyama', 'Affiliation': 'Development Headquarters, Taisho Pharmaceutical Co., Ltd, 3-24-1 Takada, Toshima, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ogo', 'Affiliation': 'Development Headquarters, Taisho Pharmaceutical Co., Ltd, 3-24-1 Takada, Toshima, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Uchimura', 'Affiliation': 'Department of Neuropsychiatry, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.'}]",Psychopharmacology,['10.1007/s00213-022-06089-6']
586,35554590,Evaluation of suvorexant for trauma-related insomnia.,"STUDY OBJECTIVES


Effective pharmacological treatments for sleep disturbance related to trauma with and without co-occurring posttraumatic stress disorder (PTSD) are needed. There is debate regarding what effects on rapid eye movement sleep (REMS) would be beneficial. Suvorexant is the first dual orexin receptor antagonist (DORA) approved for the treatment of insomnia. In contrast to most psychotropic agents, DORAs can enhance REMS while reducing arousal. We evaluated 6 weeks of suvorexant treatment for trauma-related insomnia in a double-blind, placebo-controlled clinical trial with clinical and polysomnographic evaluation.
METHODS


Participants with insomnia that followed a traumatic event were recruited from the community. Representation of current, past-only, and never having met criteria for PTSD was similar and most participants had experienced trauma-related nightmares. Participants were randomly assigned to receive suvorexant or placebo, initially at 10 mg and increased to 20 mg after 1 week, if tolerated. Polysomnography was obtained for screening, at baseline, and at 2 weeks of treatment.
RESULTS


The thirty-seven evaluable participants had significant improvement of PTSD and insomnia symptoms, however, there were no significant interactions with treatment condition. Medication was well tolerated with only one dropout being related to side effects. Within the suvorexant group increased REM segment duration correlated with concurrent PTSD symptom reduction. Nightmares remitted in all of the participants who received suvorexant and all but one of those receiving placebo.
CONCLUSIONS


A robust placebo response undermined detecting a medication effect. Further evaluation of DORAs for trauma-related insomnia, as well as factors contributing to placebo-response, are warranted.",2022,"The thirty-seven evaluable participants had significant improvement of PTSD and insomnia symptoms, however, there were no significant interactions with treatment condition.","['Participants with insomnia that followed a traumatic event were recruited from the community', 'sleep disturbance related to trauma with and without co-occurring posttraumatic stress disorder (PTSD']","['suvorexant treatment', 'placebo', 'suvorexant or placebo']","['REM segment duration', 'PTSD and insomnia symptoms']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",37.0,0.0865928,"The thirty-seven evaluable participants had significant improvement of PTSD and insomnia symptoms, however, there were no significant interactions with treatment condition.","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Mellman', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Howard University College of Medicine, Washington, DC, USA.'}, {'ForeName': 'Kiya', 'Initials': 'K', 'LastName': 'Birku', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Howard University College of Medicine, Washington, DC, USA.'}, {'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Sandhu', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Howard University College of Medicine, Washington, DC, USA.'}, {'ForeName': 'Pewu', 'Initials': 'P', 'LastName': 'Lavela', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Howard University College of Medicine, Washington, DC, USA.'}, {'ForeName': 'Ihori', 'Initials': 'I', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Howard University College of Medicine, Washington, DC, USA.'}]",Sleep,['10.1093/sleep/zsac068']
587,35263518,Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer.,"BACKGROUND


In patients with low-risk differentiated thyroid cancer undergoing thyroidectomy, the postoperative administration of radioiodine (iodine-131) is controversial in the absence of demonstrated benefits.
METHODS


In this prospective, randomized, phase 3 trial, we assigned patients with low-risk differentiated thyroid cancer who were undergoing thyroidectomy to receive ablation with postoperative administration of radioiodine (1.1 GBq) after injections of recombinant human thyrotropin (radioiodine group) or to receive no postoperative radioiodine (no-radioiodine group). The primary objective was to assess whether no radioiodine therapy was noninferior to radioiodine therapy with respect to the absence of a composite end point that included functional, structural, and biologic abnormalities at 3 years. Noninferiority was defined as a between-group difference of less than 5 percentage points in the percentage of patients who did not have events that included the presence of abnormal foci of radioiodine uptake on whole-body scanning that required subsequent treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or elevated levels of thyroglobulin or thyroglobulin antibodies. Secondary end points included prognostic factors for events and molecular characterization.
RESULTS


Among 730 patients who could be evaluated 3 years after randomization, the percentage of patients without an event was 95.6% (95% confidence interval [CI], 93.0 to 97.5) in the no-radioiodine group and 95.9% (95% CI, 93.3 to 97.7) in the radioiodine group, a difference of -0.3 percentage points (two-sided 90% CI, -2.7 to 2.2), a result that met the noninferiority criteria. Events consisted of structural or functional abnormalities in 8 patients and biologic abnormalities in 23 patients with 25 events. Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment. Molecular alterations were similar in patients with or without an event. No treatment-related adverse events were reported.
CONCLUSIONS


In patients with low-risk thyroid cancer undergoing thyroidectomy, a follow-up strategy that did not involve the use of radioiodine was noninferior to an ablation strategy with radioiodine regarding the occurrence of functional, structural, and biologic events at 3 years. (Funded by the French National Cancer Institute; ESTIMABL2 ClinicalTrials.gov number, NCT01837745.).",2022,Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment.,"['patients with low-risk thyroid cancer undergoing', 'patients with low-risk differentiated thyroid cancer who were undergoing thyroidectomy to receive ablation with postoperative administration of radioiodine (1.1 GBq) after injections of', 'patients with low-risk differentiated thyroid cancer undergoing', '730 patients', 'Patients with Low-Risk Thyroid Cancer', '23 patients with 25 events']","['thyroidectomy', 'radioiodine therapy', 'radioiodine', 'recombinant human thyrotropin (radioiodine group) or to receive no postoperative radioiodine (no-radioiodine group', 'Thyroidectomy without Radioiodine', 'radioiodine (iodine-131']","['adverse events', 'abnormal findings on neck ultrasonography, or elevated levels of thyroglobulin or thyroglobulin antibodies', 'prognostic factors for events and molecular characterization', 'postoperative serum thyroglobulin level', 'biologic abnormalities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2828294', 'cui_str': 'iodide ion I-131'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C1688582', 'cui_str': 'GBq'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C2828294', 'cui_str': 'iodide ion I-131'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0303029', 'cui_str': 'iodine I-131'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040123', 'cui_str': 'Thyroglobulin'}, {'cui': 'C0201512', 'cui_str': 'Thyroglobulin antibody measurement'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1271701', 'cui_str': 'Serum thyroglobulin level'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",730.0,0.130897,Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Leboulleux', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bournaud', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Cecile N', 'Initials': 'CN', 'LastName': 'Chougnet', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Slimane', 'Initials': 'S', 'LastName': 'Zerdoud', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Abir', 'Initials': 'A', 'LastName': 'Al Ghuzlan', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Catargi', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Do Cao', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Kelly', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Marie-Luce', 'Initials': 'ML', 'LastName': 'Barge', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lacroix', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Dygai', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Vera', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rusu', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Schneegans', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Benisvy', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Roux', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Eberle', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Bastie', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Nascimento', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Giraudet', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Le Moullec', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bardet', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Drui', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Roudaut', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Godbert', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Morel', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Drutel', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Lamartina', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Schvartz', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Fritz-Line', 'Initials': 'FL', 'LastName': 'Velayoudom', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Martin-Jean', 'Initials': 'MJ', 'LastName': 'Schlumberger', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Leenhardt', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Borget', 'Affiliation': ""From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université\xa0Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire\xa0(CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean\xa0Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.""}]",The New England journal of medicine,['10.1056/NEJMoa2111953']
588,35282967,Re: Androgen deprivation therapy and radiotherapy in intermediate risk prostate cancer: A randomized phase III trial.,,2022,,"['Re', 'intermediate risk prostate cancer']",['Androgen deprivation therapy and radiotherapy'],[],"[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0879707,,"[{'ForeName': 'Ozan Cem', 'Initials': 'OC', 'LastName': 'Guler', 'Affiliation': 'Department of Radiation Oncology, Adana Dr Turgut Noyan Research and Treatment Centre, Baskent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Onal', 'Affiliation': 'Department of Radiation Oncology, Adana Dr Turgut Noyan Research and Treatment Centre, Baskent University Faculty of Medicine, Adana, Turkey; Department of Radiation Oncology, Baskent University Faculty of Medicine, Ankara, Turkey. Electronic address: hcemonal@hotmail.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.01.041']
589,35233923,"Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D): Study rationale, design, and methods.","AIMS


Long-term data from randomized clinical trials comparing metabolic (bariatric) surgery versus a medical/lifestyle intervention for treatment of patients with obesity/overweight and type 2 diabetes (T2D) are lacking. The Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) is a consortium of four randomized trials designed to compare long-term efficacy and safety of surgery versus medical/lifestyle therapy on diabetes control and clinical outcomes.
MATERIALS AND METHODS


Patients with T2D and body mass index (BMI) of 27-45 kg/m 2  who were previously randomized to metabolic surgery (Roux-en-Y gastric bypass, adjustable gastric band, or sleeve gastrectomy) versus medical/lifestyle intervention in the STAMPEDE, SLIMM-T2D, TRIABETES, or CROSSROADS trials have been enrolled in ARMMS-T2D for observational follow-up. The primary outcome is change in glycated haemoglobin after a minimum 7 years of follow-up, with additional analyses to determine rates of diabetes remission and relapse, as well as cardiovascular and renal endpoints.
RESULTS


In total, 302 patients (192 surgical, 110 medical/lifestyle) previously randomized in the four parent studies were eligible for participation in the ARMMS-T2D observational study. Participant demographics were 71% white, 27% African-American and 68% female. At baseline: age, 50 ± 8 years; BMI, 36.5 ± 3.5 kg/m 2  ; duration of diabetes, 8.8 ± 5.6 years; glycated haemoglobin, 8.6% ± 1.6%; and fasting glucose, 168 ± 64 mg/dl. More than 35% of patients had a BMI <35 kg/m 2  .
CONCLUSIONS


ARMMS-T2D will provide the largest body of long-term, level 1 evidence to inform clinical decision-making regarding the comparative durability, efficacy and safety of metabolic surgery relative to a medical/lifestyle intervention among patients with T2D, including those with milder class I obesity or mere overweight.",2022,"In total, 302 patients (192 surgical, 110 medical/lifestyle) previously randomized in the four parent studies were eligible for participation in the ARMMS-T2D observational study.","['Type 2 Diabetes (ARMMS-T2D', 'patients with T2D, including those with milder class I obesity or mere overweight', '302 patients (192 surgical, 110 medical/lifestyle) previously randomized in the four parent studies were eligible for participation in the ARMMS-T2D observational study', 'Patients with T2D and body mass index (BMI) of 27-45\u2009kg/m 2  who were previously randomized to', 'At baseline: age, 50\u2009±\u20098\u2009years; BMI, 36.5\u2009±\u20093.5\xa0kg/m 2  ; duration of diabetes, 8.8\u2009±\u20095.6\u2009years; glycated haemoglobin, 8.6%\u2009±\u20091.6%; and fasting glucose, 168\u2009±\u200964\u2009mg/dl', 'patients with obesity/overweight and type 2 diabetes (T2D']","['metabolic (bariatric) surgery versus a medical/lifestyle intervention', 'metabolic surgery (Roux-en-Y gastric bypass, adjustable gastric band, or sleeve gastrectomy) versus medical/lifestyle intervention', 'Medicine vs Metabolic Surgery', 'surgery versus medical/lifestyle therapy']","['change in glycated haemoglobin', 'rates of diabetes remission and relapse, as well as cardiovascular and renal endpoints']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1960832', 'cui_str': 'Partitioning of stomach using band'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",302.0,0.149306,"In total, 302 patients (192 surgical, 110 medical/lifestyle) previously randomized in the four parent studies were eligible for participation in the ARMMS-T2D observational study.","[{'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Simonson', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Arterburn', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Schauer', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Sangeeta R', 'Initials': 'SR', 'LastName': 'Kashyap', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Anita P', 'Initials': 'AP', 'LastName': 'Courcoulas', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cummings', 'Affiliation': 'University of Washington Medical School, Seattle, Washington, USA.'}, {'ForeName': 'Mary-Elizabeth', 'Initials': 'ME', 'LastName': 'Patti', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Gourash', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Vernon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'AdventHealth Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14680']
590,35297138,Comparative efficacy of using a combination of intralesional purified protein derivative with low dose isotretinoin in the treatment of recalcitrant common warts.,"Intralesional immunotherapy with purified protein derivative (PPD) is an effective and tolerable therapeutic modality for the treatment of common warts. However, the complete clearance rates are still unsatisfactory. We thought to evaluate the efficacy and safety of adding low dose isotretinoin to intralesional PPD versus PPD monotherapy for viral warts. The study included two groups: Group (A) was treated by intralesional PPD at 2-week intervals until complete clearance or for a maximum of six sessions in addition to an oral placebo. Group (B): was treated with both intralesional PPD and low dose isotretinoin for a 3-month course. There was no statistically significant difference between both groups regarding the therapeutic response. In common warts, the low dose of isotretinoin did not add a true therapeutic value in the studied groups. Perhaps higher doses of isotretinoin could provide a better response, which warrants further investigation.",2022,"In common warts, the low dose of isotretinoin did not add a true therapeutic value in the studied groups.",['recalcitrant common warts'],"['placebo', 'PPD monotherapy', 'intralesional PPD and low dose isotretinoin', 'intralesional PPD', 'intralesional purified protein derivative with low dose isotretinoin']","['therapeutic response', 'efficacy and safety']","[{'cui': 'C0043037', 'cui_str': 'Verruca'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0507857,"In common warts, the low dose of isotretinoin did not add a true therapeutic value in the studied groups.","[{'ForeName': 'Nagwa', 'Initials': 'N', 'LastName': 'Diab', 'Affiliation': 'Dermatology, Venereology & Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Hend', 'Initials': 'H', 'LastName': 'Atef', 'Affiliation': 'Dermatology, Venereology & Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Salah', 'Affiliation': 'Dermatology, Venereology & Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}]",Dermatologic therapy,['10.1111/dth.15457']
591,35297121,"Editorial Comment to Combination therapy with tamsulosin and traditional herbal medicine for lower urinary tract symptoms due to benign prostatic hyperplasia: A double-blinded, randomized, pilot clinical trial.",,2022,,['lower urinary tract symptoms due to benign prostatic hyperplasia'],['tamsulosin and traditional herbal medicine'],[],"[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}]",[],,0.686643,,"[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Matsuo', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': 'Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14844']
592,35297108,"Impact of fixed-dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52-week randomized, double-blind, PSO-LONG trial.","BACKGROUND


Psoriasis contributes to unemployment, work impairment, missed workdays and substantial indirect costs due to lost productivity. Combination Cal/BD foam is the only topical that is approved for long-term maintenance treatment of plaque psoriasis for 52 weeks. This is the first known investigation of the effect of topical psoriasis therapy on productivity.
OBJECTIVE


To examine the change in work productivity and activity impairment after 4 weeks of treatment with fixed-dose combination calcipotriol 50 µg/g/betamethasone dipropionate 0.5 mg/g (Cal/BD) foam and observe long-term changes after 52 weeks of long-term management (proactive or reactive treatment).
METHODS


This is a post-hoc analysis of the PSO-LONG trial - a phase 3, randomized, double-blind, vehicle-controlled, parallel group, international multi-centre trial of treatment with combination Cal/BD foam. Work and activity impairment due to psoriasis were assessed by the Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment Psoriasis (WPAI:PSO) questionnaire at baseline, week 4, week 28 and week 56. The improvement in hours of work productivity was translated into monthly and annual indirect cost savings estimates for patients in Italy, Sweden, United Kingdom, Canada and Germany.
RESULTS


Using fixed-dose combination Cal/BD foam for four weeks significantly reduced psoriasis-related work presenteeism, total work productivity impairment (TWPI) and total activity impairment (TAI) over 56 weeks, with significant improvements observed as early as 4 weeks after the baseline visit. The proportion of patients reporting impact on work productivity (as measured by presenteeism and TWPI) and activity impairment (as measured by both DLQI-Q7b and TAI) also decreased.
CONCLUSION


Fixed-dose combination Cal/BD foam used for long-term management of psoriasis significantly reduces psoriasis-related work productivity and activity impairment which may result in substantial indirect cost savings. Clinical Trial Registration NCT02899962, EudraCT number: 2016-000556-95.",2022,"The improvement in hours of work productivity was translated into monthly and annual indirect cost savings estimates for patients in Italy, Sweden, UK, Canada, and Germany.
",['patients with psoriasis'],"['combination Cal/BD foam', 'topical psoriasis therapy', 'betamethasone dipropionate 0.5 mg/g (Cal/BD) foam and observe long-term changes after 52 weeks of long-term management (proactive or reactive treatment', 'fixed-dose combination Cal/BD foam']","['hours of work productivity', 'work productivity and activity impairment', 'work productivity', 'psoriasis-related work presenteeism, total work productivity impairment (TWPI) and total activity impairment (TAI', 'productivity', 'Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment Psoriasis (WPAI:PSO) questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3653162', 'cui_str': 'calcipotriol, combinations'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.22446,"The improvement in hours of work productivity was translated into monthly and annual indirect cost savings estimates for patients in Italy, Sweden, UK, Canada, and Germany.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Guenther', 'Affiliation': 'Guenther Research Inc., London, ON, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Takhar', 'Affiliation': 'Wansford and Kings Cliffe Practice, Wansford, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Megna', 'Affiliation': 'Dermatology Unit, Department of Clinical Medicine and Surgery, University Federico II, Naples, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sebastian', 'Affiliation': 'Center for Dermatology and Clinical Trials, Mahlow, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nyholm', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Thoning', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'L-Å', 'Initials': 'LÅ', 'LastName': 'Levin', 'Affiliation': 'Department of Medical and Health Sciences, Division of Health Care Analysis, Linköping University, Linköping, Sweden.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.18053']
593,35297106,"Combination therapy with tamsulosin and traditional herbal medicine for lower urinary tract symptoms due to benign prostatic hyperplasia: A double-blinded, randomized, pilot clinical trial.","OBJECTIVES


To evaluate the efficacy and safety of tamsulosin and Hachimijiogan or Ryutanshakanto in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.
METHODS


A prospective, randomized, double-blind method was used to determine the efficacy and safety of the combination or placebo at baseline and 4, 8, and 12 weeks of study. The International Prostate Symptom Score, quality of life index, complete voiding diary, and National Institutes of Health-Chronic Prostatitis Symptom Index were studied. Uroflowmetery and postvoid residual urine volume were measured and compared. Laboratory tests including prostate-specific antigen were performed.
RESULTS


In all groups, International Prostate Symptom Score and quality of life showed improvement, but no significant differences were shown among the groups. Prostate volume increased after treatment, and uroflowmetric parameters showed improvements after treatment without significance among the three groups. The total score of the National Institutes of Health-Chronic Prostatitis Symptom Index showed a significant improvement in all groups, without significant differences among the groups. Only the pain sub-score of the National Institutes of Health-Chronic Prostatitis Symptom Index showed a significant decrease in the tamsulosin with Ryutanshakanto group compared to the control group. A total of 11 adverse reactions occurred, but they were mild and not related to the study drugs.
CONCLUSION


Ryutanshakanto can provide pain relief in patients with chronic prostatitis and chronic pelvic pain syndrome. If more research is conducted, Hachimijiogan and Ryutanshakanto may be applied as add-on treatments in patients with storage symptoms with alpha-blocker monotherapy.",2022,"In all groups, International Prostate Symptom Score and quality of life showed improvement, but no significant differences were shown among the groups.","['lower urinary tract symptoms due to benign prostatic hyperplasia', 'patients with storage symptoms with alpha-blocker monotherapy', 'patients with chronic prostatitis and chronic pelvic pain syndrome', 'patients with lower urinary tract symptoms due to benign prostatic hyperplasia']","['tamsulosin and Hachimijiogan or Ryutanshakanto', 'tamsulosin and traditional herbal medicine', 'placebo', 'Ryutanshakanto']","['International Prostate Symptom Score, quality of life index, complete voiding diary, and National Institutes of Health-Chronic Prostatitis Symptom Index', 'International Prostate Symptom Score and quality of life', 'pain relief', 'total score of the National Institutes of Health-Chronic Prostatitis Symptom Index', 'efficacy and safety', 'Prostate volume', 'Uroflowmetery and postvoid residual urine volume', 'pain sub-score of the National Institutes of Health-Chronic Prostatitis Symptom Index']","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001641', 'cui_str': 'Alpha adrenergic receptor antagonist'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0062075', 'cui_str': 'hachimijiogan'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]",,0.266169,"In all groups, International Prostate Symptom Score and quality of life showed improvement, but no significant differences were shown among the groups.","[{'ForeName': 'Chung Lyul', 'Initials': 'CL', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Hyeun-Kyoo', 'Initials': 'HK', 'LastName': 'Shin', 'Affiliation': 'Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Ji Yong', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Ojin', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Chang-Seob', 'Initials': 'CS', 'LastName': 'Seo', 'Affiliation': 'Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Ae-Ran', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': 'Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Bok-Nam', 'Initials': 'BN', 'LastName': 'Seo', 'Affiliation': 'Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Seung Woo', 'Initials': 'SW', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Ki Hak', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': 'Department of Urology, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Jae Sung', 'Initials': 'JS', 'LastName': 'Lim', 'Affiliation': 'Department of Urology, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Jong Mok', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Department of Urology, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Yong Gil', 'Initials': 'YG', 'LastName': 'Na', 'Affiliation': 'Department of Urology, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Urology, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14821']
594,35306633,The Economic Burden of Insulin Injection-Induced Lipohypertophy. Role of Education: The ISTERP-3 Study.,"INTRODUCTION


The history of insulin-induced skin lipohypertrophy (LH) runs parallel to that of insulin's 100 years, and an average of 47% of insulin-treated patients still suffer from it today. The metabolic and economic effects of LH are significant, with hypoglycemia being the most striking. The objective of the study was to perform a 52-week follow-up of 713 insulin-treated patients with type 2 diabetes (T2DM) and LH to detect any differences in the occurrence of hypoglycemic events (HYPOs) and related healthcare costs as well as in LH rates and injection habits between an intensive education intervention group (IG) and control group (CG) provided with a single educational session at the starting point.
METHODS


All participants were trained in accurately self-monitoring blood glucose and recording all HYPOs for 6 months, which allowed baseline recordings before they were randomized into the IG, comprising 395 insulin-treated subjects undergoing repeated, structured multimodal education on correct injection techniques as a longstanding behavioral rehabilitation strategy, and the CG, comprising 318 subjects receiving the same structured, multimodal educational session, but only initially.
RESULTS


Changes in LH rate and size and in performance were large in the IG and only slight and transient in the CG. A striking difference in the rate of decrease of HYPOs was also apparent between groups. Indeed, estimated costs of health interventions for severe and symptomatic HYPOs, which were on the order of €70,000 and €9300, respectively, in the two groups at baseline decreased by 5.9 times and 13.7 times, respectively, at the end of follow-up in the IG and by only approximately half in the CG. Full details of the changes occurring as a result of intensive education are provided in the text.
CONCLUSIONS


The effect of only initial education in the CG was not significant, thus providing evidence of the virtual worthlessness of a single training session on injection techniques, typical of worldwide daily clinical practice, and easily explaining the extremely high prevalence of LH in insulin-treated patients. Conversely, highly positive effects on LH prevalence and size as well as costs expected from decreased HYPO rate were obtained in the IG. To our knowledge, ours is the first 18-month randomized trial in the field. If our experimental model were to be used as an effective, longstanding behavioral rehabilitation strategy and therefore adapted to real-world settings universally, LH prevalence and costs related to their clinical consequences would be drastically reduced. However, only with a strong, relentless commitment of universities, scientific societies, and patient associations can we achieve this ambitious goal, which would provide great institutional savings and improved quality of life for people with diabetes.",2022,"The effect of only initial education in the CG was not significant, thus providing evidence of the virtual worthlessness of a single training session on injection techniques, typical of worldwide daily clinical practice, and easily explaining the extremely high prevalence of LH in insulin-treated patients.","['people with diabetes', '713 insulin-treated patients with type 2 diabetes (T2DM']","['Education', 'Insulin Injection-Induced Lipohypertophy', '395 insulin-treated subjects undergoing repeated, structured multimodal education', 'intensive education intervention group (IG) and control group (CG) provided with a single educational session at the starting point']","['LH prevalence and size', 'occurrence of hypoglycemic events (HYPOs) and related healthcare costs as well as in LH rates and injection habits', 'HYPO rate', 'quality of life', 'rate of decrease of HYPOs', 'LH rate and size and in performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C1262113', 'cui_str': 'Lipohypertrophy'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",318.0,0.0317345,"The effect of only initial education in the CG was not significant, thus providing evidence of the virtual worthlessness of a single training session on injection techniques, typical of worldwide daily clinical practice, and easily explaining the extremely high prevalence of LH in insulin-treated patients.","[{'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Gentile', 'Affiliation': 'Nefrocenter Research and Nyx Start-Up, Naples, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Guarino', 'Affiliation': 'Nefrocenter Research and Nyx Start-Up, Naples, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Della Corte', 'Affiliation': 'Nefrocenter Research and Nyx Start-Up, Naples, Italy.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Marino', 'Affiliation': 'Department of Internal Medicine, Campania University ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Ersilia', 'Initials': 'E', 'LastName': 'Satta', 'Affiliation': 'Nefrocenter Research and Nyx Start-Up, Naples, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pasquarella', 'Affiliation': 'Nefrocenter Research and Nyx Start-Up, Naples, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Romano', 'Affiliation': 'Nefrocenter Research and Nyx Start-Up, Naples, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Alfrone', 'Affiliation': 'Nefrocenter Research and Nyx Start-Up, Naples, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Giordano', 'Affiliation': 'Emodialysis Center Srl, Nefrocenter Network, Naples, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Loiacono', 'Affiliation': 'Nefrocenter Research, Naples, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Capece', 'Affiliation': 'Vomero Center Crisci Bersabea & C SNC, Nefrocenter Network, Naples, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Lamberti', 'Affiliation': 'Metelliano Medical Center, Nefrocenter Network, Naples, Italy.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Strollo', 'Affiliation': 'Endocrinology and Diabetes, IRCCS San Raffaele Pisana, Rome, Italy. felix.strollo@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-022-02105-5']
595,35314945,Effect of Preserving the Percutaneous Gallbladder Drainage Tube Before Laparoscopic Cholecystectomy on Surgical Outcome: Post Hoc Analysis of the CSGO-HBP-017.,"BACKGROUND


When percutaneous transhepatic gallbladder drainage (PTGBD) is followed by laparoscopic cholecystectomy (LC), there is no consensus regarding whether the drainage tube should be preserved or removed before LC. We hypothesized that the surgical results of LC might differ between cases with PTGBD tube preservation versus removal. Here, we investigated how drainage tube preservation or removal affected the surgical outcome of LC.
METHODS


Using data from our previous multicenter study, we compared LC outcomes after PTGBD between patients with PTGBD tube preservation versus removal. This study included 208 patients who underwent LC over 12 days after PTGBD. In 83 cases, the PTGBD tube was preserved until LC, and in 125 cases, the tube was removed before LC. The results were verified by propensity score matching with 50 patients in each group.
RESULTS


Cases with tube preservation versus removal exhibited significantly longer surgery duration (174 ± 105 min vs 145 ± 61 min, P = .0118) and postoperative hospital stay (14 ± 16 days vs 7 ± 7 days, P < .0001), a significantly higher postoperative complication rate (13.2% vs 3.2%, P = .0061), and a marginally higher incidence of open conversion (12.0% vs 4.8%, P = .0547). Propensity score matching verified the inferior surgical outcomes in cases with tube preservation.
CONCLUSIONS


These results imply that when LC is performed > 12 days after PTGBD, the surgical outcome may be inferior when the drainage tube is preserved rather than removed before LC.",2022,"RESULTS


Cases with tube preservation versus removal exhibited significantly longer surgery duration (174 ± 105 min vs 145 ± 61 min, P = .0118) and postoperative hospital stay (14 ± 16 days vs 7 ± 7 days, P < .0001), a significantly higher postoperative complication rate (13.2% vs 3.2%, P = .0061), and a marginally higher incidence of open conversion (12.0% vs 4.8%, P = .0547).","['208 patients who underwent LC over 12\xa0days after PTGBD', 'cases with tube preservation']","['Percutaneous Gallbladder Drainage Tube', 'PTGBD tube preservation versus removal', 'Laparoscopic Cholecystectomy', 'laparoscopic cholecystectomy (LC', 'percutaneous transhepatic gallbladder drainage (PTGBD']","['surgery duration', 'open conversion', 'postoperative complication rate', 'Surgical Outcome', 'postoperative hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0522516', 'cui_str': 'Transhepatic approach'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0522516', 'cui_str': 'Transhepatic approach'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",208.0,0.014158,"RESULTS


Cases with tube preservation versus removal exhibited significantly longer surgery duration (174 ± 105 min vs 145 ± 61 min, P = .0118) and postoperative hospital stay (14 ± 16 days vs 7 ± 7 days, P < .0001), a significantly higher postoperative complication rate (13.2% vs 3.2%, P = .0061), and a marginally higher incidence of open conversion (12.0% vs 4.8%, P = .0547).","[{'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Tomimaru', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka E-2, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Nariaki', 'Initials': 'N', 'LastName': 'Fukuchi', 'Affiliation': 'Department of Surgery, Suita Municipal Hospital, Suita, Japan.'}, {'ForeName': 'Shigekazu', 'Initials': 'S', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Department of Surgery, Tane General Hospital, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tanemura', 'Affiliation': 'Department of Surgery, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakai', 'Affiliation': 'Department of Surgery, Japan Community Health Care Organization, Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Takeda', 'Affiliation': 'Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Tsujie', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Nara Hospital, Kinki University, Ikoma, Japan.'}, {'ForeName': 'Terumasa', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Yasuji', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Hisanori', 'Initials': 'H', 'LastName': 'Hatano', 'Affiliation': 'Department of Surgery, Rinku General Medical Center, Osaka, Japan.'}, {'ForeName': 'Junzo', 'Initials': 'J', 'LastName': 'Shimizu', 'Affiliation': 'Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Surgery, Minoh City Hospital, Minoh, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kashiwazaki', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka E-2, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka E-2, Suita, Osaka, 565-0871, Japan. skobayashi@gesurg.med.osaka-u.ac.jp.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka E-2, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka E-2, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-022-05291-3']
596,35320369,Another trial for the TARGET trial. Author's reply.,,2022,,[],[],[],[],[],[],,0.229136,,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hagel', 'Affiliation': 'Institute for Infectious Diseases and Infection Control, Jena University Hospital - Friedrich Schiller University Jena, Jena, Germany. stefan.hagel@med.uni-jena.de.'}, {'ForeName': 'Mathias W', 'Initials': 'MW', 'LastName': 'Pletz', 'Affiliation': 'Institute for Infectious Diseases and Infection Control, Jena University Hospital - Friedrich Schiller University Jena, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'Institute of Medical Statistics, Computer Sciences and Data Sciences, Jena University Hospital - Friedrich Schiller University Jena, Jena, Germany.'}]",Intensive care medicine,['10.1007/s00134-022-06670-9']
597,35323079,Immunogenicity and reactogenicity after heterologous prime-boost vaccination with CoronaVac and ChAdox1 nCov-19 (AZD1222) vaccines.,"Mass vaccination with a safe and effective vaccine may be the best way to control the COVID-19 pandemic. Heterologous prime-boost vaccination with the CoronaVac and AZD1222 vaccines may increase the immunogenicity elicited by either vaccine alone. This study sought to compare the immunogenicity of a heterologous CoronaVac and AZD1222 prime-boost with a homologous CoronaVac prime-boost. From July 13 to September 2, 2021, 88 participants were enrolled in the study. Half (n = 44) of the participants were assigned to the AZD1222/CoronaVac cohort and half were assigned to the CoronaVac/AZD1222 cohort. Both cohorts had a prime-boost interval of 4 weeks. A control group of 136 health care personnel who received the homologous CoronaVac/CoronaVac prime-boost was matched by age and sex to the experimental cohorts. The primary endpoint was the geometric mean ratio (GMR) of the anti-receptor binding domain (RBD) antibody concentration 4 weeks after the booster dose was administered. The CoronaVac/CoronaVac cohort served as the reference group. Baseline age and sex were similar, and the median age was 42.5 years. The GMR was 2.58 (95% confidence interval [CI] 1.80-3.71) and 8.69 (95% CI 6.05-12.47) in the AZD1222/CoronaVac and CoronaVac/AZD1222 cohorts, respectively. Reactogenicity was similar following prime and booster doses with the same vaccine. Findings indicated that the heterologous CoronaVac and AZD1222 prime-boost combination elicited a more robust immune response than the homologous CoronaVac prime-boost. While both heterologous prime-boost combinations showed similar reactogenicity, the immunogenicity of the CoronaVac/AZD1222 cohort was higher, indicating that the order of prime-boost vaccine administration was important.",2022,"The GMR was 2.58 (95% confidence interval [CI] 1.80-3.71) and 8.69 (95% CI 6.05-12.47) in the AZD1222/CoronaVac and CoronaVac/AZD1222 cohorts, respectively.","['From July 13 to September 2, 2021, 88 participants were enrolled in the study', 'Half (n\u2009=\u200944) of the participants were assigned to the AZD1222/CoronaVac cohort and half were assigned to the CoronaVac/AZD1222 cohort', '136 health care personnel who received the']","['heterologous prime-boost vaccination with CoronaVac and ChAdox1 nCov-19 (AZD1222) vaccines', 'heterologous CoronaVac and AZD1222 prime-boost with a homologous CoronaVac prime-boost', 'homologous CoronaVac/CoronaVac prime-boost']","['Immunogenicity and reactogenicity', 'Reactogenicity', 'GMR', 'geometric mean ratio (GMR) of the anti-receptor binding domain (RBD) antibody concentration']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",88.0,0.158043,"The GMR was 2.58 (95% confidence interval [CI] 1.80-3.71) and 8.69 (95% CI 6.05-12.47) in the AZD1222/CoronaVac and CoronaVac/AZD1222 cohorts, respectively.","[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Cohen', 'Affiliation': 'Department of General Practice and Family Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Pawornrath', 'Initials': 'P', 'LastName': 'Jungsomsri', 'Affiliation': 'Department of General Practice and Family Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Jirath', 'Initials': 'J', 'LastName': 'Sangwongwanich', 'Affiliation': 'Department of General Practice and Family Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Kriangkrai', 'Initials': 'K', 'LastName': 'Tawinprai', 'Affiliation': 'Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Taweegrit', 'Initials': 'T', 'LastName': 'Siripongboonsitti', 'Affiliation': 'Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Thachanun', 'Initials': 'T', 'LastName': 'Porntharukchareon', 'Affiliation': 'Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Kasiruck', 'Initials': 'K', 'LastName': 'Wittayasak', 'Affiliation': ""Center of Learning and Research in Celebration of HRH Princess Chulabhorn's 60th Birthday Anniversary, Chulabhorn Royal Academy, Bangkok, Thailand.""}, {'ForeName': 'Nawarat', 'Initials': 'N', 'LastName': 'Thonwirak', 'Affiliation': ""Center of Learning and Research in Celebration of HRH Princess Chulabhorn's 60th Birthday Anniversary, Chulabhorn Royal Academy, Bangkok, Thailand.""}, {'ForeName': 'Kamonwan', 'Initials': 'K', 'LastName': 'Soonklang', 'Affiliation': ""Center of Learning and Research in Celebration of HRH Princess Chulabhorn's 60th Birthday Anniversary, Chulabhorn Royal Academy, Bangkok, Thailand.""}, {'ForeName': 'Gaidganok', 'Initials': 'G', 'LastName': 'Sornsamdang', 'Affiliation': 'Central Laboratory Center, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand.'}, {'ForeName': 'Chirayu', 'Initials': 'C', 'LastName': 'Auewarakul', 'Affiliation': ""Center of Learning and Research in Celebration of HRH Princess Chulabhorn's 60th Birthday Anniversary, Chulabhorn Royal Academy, Bangkok, Thailand.""}, {'ForeName': 'Nithi', 'Initials': 'N', 'LastName': 'Mahanonda', 'Affiliation': 'Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2052525']
598,35286796,Risk factors for overcorrection of severe hyponatremia: a post hoc analysis of the SALSA trial.,"BACKGROUND


Hyponatremia overcorrection can result in irreversible neurologic impairment such as osmotic demyelination syndrome. Few prospective studies have identified patients undergoing hypertonic saline treatment with a high risk of hyponatremia overcorrection.
METHODS


We conducted a post hoc analysis of a multicenter, prospective randomized controlled study, the SALSA trial, in 178 patients aged above 18 years with symptomatic hyponatremia (mean age, 73.1 years; mean serum sodium level, 118.2 mEq/L). Overcorrection was defined as an increase in serum sodium levels by >12 or 18 mEq/L within 24 or 48 hours, respectively.
RESULTS


Among the 178 patients, 37 experienced hyponatremia overcorrection (20.8%), which was independently associated with initial serum sodium level (≤110, 110-115, 115-120, and 120-125 mEq/L with 7, 4, 2, and 0 points, respectively), chronic alcoholism (7 points), severe symptoms of hyponatremia (3 points), and initial potassium level (<3.0 mEq/L, 3 points). The NASK (hypoNatremia, Alcoholism, Severe symptoms, and hypoKalemia) score was derived from four risk factors for hyponatremia overcorrection and was significantly associated with overcorrection (odds ratio, 1.41; 95% confidence interval, 1.24-1.61; p < 0.01) with good discrimination (area under the receiver-operating characteristic [AUROC] curve, 0.76; 95% CI, 0.66-0.85; p < 0.01). The AUROC curve of the NASK score was statistically better compared with those of each risk factor.
CONCLUSION


In treating patients with symptomatic hyponatremia, individuals with high hyponatremia overcorrection risks were predictable using a novel risk score summarizing baseline information.",2022,"Among the 178 patients, 37 experienced hyponatremia overcorrection (20.8%), which was independently associated with initial serum sodium level (≤110, 110-115, 115-120, and 120-125 mEq/L with 7, 4, 2, and 0 points, respectively), chronic alcoholism (7 points), severe symptoms of hyponatremia (3 points), and initial potassium level (<3.0 mEq/L, 3 points).","['7 points), severe symptoms of hyponatremia (3 points), and initial potassium level (<3.0 mEq/L, 3 points', '178 patients, 37 experienced', '178 patients aged above 18 years with symptomatic hyponatremia (mean age, 73.1 years; mean serum sodium level, 118.2 mEq/L', 'patients with symptomatic hyponatremia, individuals with high hyponatremia overcorrection risks', 'severe hyponatremia']",['hypertonic saline'],"['NASK (hypoNatremia, Alcoholism, Severe symptoms, and hypoKalemia) score', 'hyponatremia overcorrection', 'chronic alcoholism', 'serum sodium levels', 'initial serum sodium level']","[{'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0439375', 'cui_str': 'mEq/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",178.0,0.12904,"Among the 178 patients, 37 experienced hyponatremia overcorrection (20.8%), which was independently associated with initial serum sodium level (≤110, 110-115, 115-120, and 120-125 mEq/L with 7, 4, 2, and 0 points, respectively), chronic alcoholism (7 points), severe symptoms of hyponatremia (3 points), and initial potassium level (<3.0 mEq/L, 3 points).","[{'ForeName': 'Huijin', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.'}, {'ForeName': 'Songuk', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.'}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.'}, {'ForeName': 'Jang Won', 'Initials': 'JW', 'LastName': 'Seo', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.'}, {'ForeName': 'Ja-Ryong', 'Initials': 'JR', 'LastName': 'Koo', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.'}, {'ForeName': 'Yun Kyu', 'Initials': 'YK', 'LastName': 'Oh', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'You Hwan', 'Initials': 'YH', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Sejoong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Seon Ha', 'Initials': 'SH', 'LastName': 'Baek', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.'}]",Kidney research and clinical practice,['10.23876/j.krcp.21.180']
599,35294778,Effect of a PCSK9 inhibitor and a statin on cholesterol efflux capacity: A limitation of current cholesterol-lowering treatments?,"BACKGROUND


Cellular cholesterol efflux is a key step in reverse cholesterol transport that may impact on atherosclerotic cardiovascular risk. The process may be reliant on the availability of apolipoprotein (apo) B-100-containing lipoproteins to accept cholesterol from high-density lipoprotein. Evolocumab and atorvastatin are known to lower plasma apoB-100-containing lipoproteins that could impact on cholesterol efflux capacity (CEC).
METHODS


We conducted a 2-by-2 factorial trial of the effects of subcutaneous evolocumab (420 mg every 2 weeks) and atorvastatin (80 mg daily) for 8 weeks on CEC in 81 healthy, normolipidaemic men. The capacity of whole plasma and apoB-depleted plasma, including ATP-binding cassette transporter A1 (ABCA1)-mediated and passive diffusion, to efflux cholesterol, was measured.
RESULTS


Evolocumab and atorvastatin independently decreased whole plasma CEC (main effect p < .01 for both). However, there were no significant effects of evolocumab and atorvastatin on apoB-depleted plasma, ABCA1-mediated and passive diffusion-mediated CEC (p > .05 in all). In the three intervention groups combined, the reduction in whole plasma CEC was significantly correlated with the corresponding reduction in plasma apoB-100 concentration (r = .339, p < .01). In the evolocumab monotherapy group, the reduction in whole plasma CEC was also significantly correlated with the corresponding reduction in plasma lipoprotein(a) concentration (r = .487, p < .05).
CONCLUSIONS


In normolipidaemic men, evolocumab and atorvastatin decrease the capacity of whole plasma to efflux cellular cholesterol. These effects may be chiefly owing to a fall in the availability of apoB-100-containing lipoproteins. Reduction in circulating lipoprotein(a) may also contribute to the decrease in whole plasma cholesterol efflux with evolocumab monotherapy.",2022,"RESULTS


Evolocumab and atorvastatin independently decreased whole plasma CEC (main effect P<0.01 for both).","['81 healthy, normolipidaemic men']","['PCSK9 Inhibitor and a Statin', 'evolocumab and atorvastatin', 'Evolocumab and atorvastatin', 'subcutaneous evolocumab', 'atorvastatin']","['whole plasma CEC', 'plasma apoB-100 concentration', 'apoB-depleted plasma, ABCA1-mediated and passive diffusion-mediated CEC', 'capacity of whole plasma and apoB-depleted plasma, including ATP binding cassette transporter A1 (ABCA1)-mediated and passive diffusion, to efflux cholesterol', 'capacity of whole plasma to efflux cellular cholesterol', 'plasma CEC', 'plasma lipoprotein(a) concentration', 'cholesterol efflux capacity (CEC']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C4521460', 'cui_str': 'PCSK9 inhibitor'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205666', 'cui_str': 'Apolipoprotein B-100'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0583325', 'cui_str': 'Plasma lipoprotein measurement'}]",,0.0551274,"RESULTS


Evolocumab and atorvastatin independently decreased whole plasma CEC (main effect P<0.01 for both).","[{'ForeName': 'Qidi', 'Initials': 'Q', 'LastName': 'Ying', 'Affiliation': 'Medical School, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Ronca', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Dick C', 'Initials': 'DC', 'LastName': 'Chan', 'Affiliation': 'Medical School, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': 'Medical School, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Elda', 'Initials': 'E', 'LastName': 'Favari', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Gerald F', 'Initials': 'GF', 'LastName': 'Watts', 'Affiliation': 'Medical School, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia.'}]",European journal of clinical investigation,['10.1111/eci.13766']
600,35301810,A thorough QTc study to evaluate the effects of oral rilzabrutinib administered alone and with ritonavir in healthy subjects.,"This study aimed to define the clinically relevant supratherapeutic dose of rilzabrutinib, an oral Bruton tyrosine kinase (BTK) inhibitor, and evaluate potential effects of therapeutic and supratherapeutic exposures on cardiac repolarization in healthy subjects. This was a two-part phase I study (anzctr.org.au ACTRN12618001036202). Part A was a randomized, open-label, three-period, single-dose crossover study (n = 12) with rilzabrutinib 100 mg ± ritonavir 100 mg or rilzabrutinib 1200 mg. Part B was a randomized, double-blind, placebo-controlled, four-way, single-dose crossover study (n = 39) with matched placebo, rilzabrutinib 400 mg ± ritonavir 100 mg, or moxifloxacin (positive control). Primary objectives: part A - pharmacokinetics (PK) of rilzabrutinib ± ritonavir, safety, and optimal dose for Part B; Part B - effect of rilzabrutinib therapeutic and supratherapeutic concentration on electrocardiogram (ECG) parameters. ECGs and PK samples were serially recorded before and post-dose. In part A, rilzabrutinib 100 mg + ritonavir led to 17-fold area under the concentration-time curve (AUC 0-∞  ) and 7-fold maximum plasma concentration (C max  ) increases over rilzabrutinib alone. Rilzabrutinib 1200 mg was discontinued due to mild-to-moderate gastrointestinal intolerance. In Part B, rilzabrutinib 400 mg + ritonavir increased rilzabrutinib mean AUC 0-∞  from 454 to 3800 ng h/mL and C max  from 144 to 712 ng/mL. The concentration-QTc relationship was slightly negative, shallow (-0.01 ms/ng/mL [90% CI -0.016 to -0.001]), and an effect >10 ms on QTcF could be excluded within the observed range of plasma concentrations, up to 2500 ng/mL. Safety was similar to other studies of rilzabrutinib. In conclusion, rilzabrutinib, even at supratherapeutic doses, had no clinically relevant effects on ECG parameters, including the QTc interval.",2022,"In conclusion, rilzabrutinib, even at supratherapeutic doses, had no clinically relevant effects on ECG parameters, including the QTc interval.",['healthy subjects'],"['placebo', 'placebo, rilzabrutinib 400 mg±ritonavir 100 mg, or moxifloxacin (positive control', '100 mg±ritonavir 100 mg or rilzabrutinib', 'oral rilzabrutinib administered alone and with ritonavir', 'rilzabrutinib therapeutic and supratherapeutic concentration', 'rilzabrutinib']","['concentration-time curve (AUC 0-∞  ) and 7-fold maximum plasma concentration (C max  ', 'concentration-QTc relationship']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",12.0,0.108909,"In conclusion, rilzabrutinib, even at supratherapeutic doses, had no clinically relevant effects on ECG parameters, including the QTc interval.","[{'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Ucpinar', 'Affiliation': 'Principia Biopharma Inc., A Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'ERT, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Neale', 'Affiliation': 'Principia Biopharma Inc., A Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Nunn', 'Affiliation': 'Principia Biopharma Inc., A Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Shu', 'Affiliation': 'Principia Biopharma Inc., A Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Chu', 'Affiliation': 'Principia Biopharma Inc., A Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Kavanagh', 'Affiliation': 'Principia Biopharma Inc., A Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'ERT, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Pasit', 'Initials': 'P', 'LastName': 'Phiasivongsa', 'Affiliation': 'Principia Biopharma Inc., A Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Dolca', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Principia Biopharma Inc., A Sanofi Company, South San Francisco, California, USA.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Smith', 'Affiliation': 'Certara, Princeton, New Jersey, USA.'}]",Clinical and translational science,['10.1111/cts.13271']
601,35314325,Comparative biochemical efficacy analysis of an alpha 1 -proteinase inhibitor (Glassia®) in patients with alpha-1 antitrypsin deficiency.,"Alpha 1 -proteinase inhibitor (A1PI) augmentation is the only specific treatment targeting the underlying deficiency in alpha 1 -antitrypsin deficiency (AATD). The demonstration of efficacy has been based on maintaining the biochemical surrogate endpoints of plasma antigenic and functional A1PI levels above >11 μM. Here we report a biochemical comparability analysis based on data from a phase 2/3, randomized, double-blind, two-arm study with partial crossover of Glassia® (Baxalta US Inc. Westlake Village, CA, USA) and Prolastin® (Grifols Therapeutics LLC, Research Triangle Park, NC, USA) in patients with AATD (NCT00460096). Patients (N = 50) were randomly assigned in a 2:1 ratio to receive either Glassia (n = 33) or Prolastin (n = 17), respectively. In the present study, data from patients in the per-protocol population (n = 29, Glassia; n = 12, Prolastin) were analyzed. We compared the biochemical efficacy of these two A1PI products at steady state of A1PI in plasma after weekly intravenous administration of A1PI at a dose of 60 mg/kg body weight. For both antigenic and functional A1PI levels, with or without baseline correction, the geometric mean ratios (GMRs) of plasma trough levels (Glassia/Prolastin) over a 6-week period at steady state (Weeks 7-12 post-randomization) were near or above 100%, with the 90% confidence intervals (CIs) contained within the 80%-125% interval. For antigenic A1PI, the GMR (90% CI) was 115.8% (108.1-124.2) for baseline corrected and 114.2% (109.2-119.5) for uncorrected concentrations. For functional A1PI, the GMR (90% CI) was 98.7 (92.5-105.4) for baseline corrected and 107.8% (102.3-113.5) for uncorrected concentrations. In conclusion, the biochemical efficacy of Glassia using the endpoints of plasma antigenic and functional A1PI trough concentrations at steady state was comparable with Prolastin in patients with AATD.",2022,"For antigenic A1PI, the GMR (90% CI) was 115.8% (108.1-124.2) for baseline corrected and 114.2% (109.2-119.5) for uncorrected concentrations.","['Patients (N\u202f=\u202f50', 'patients with alpha-1 antitrypsin deficiency', 'patients with AATD', 'patients in the per-protocol population (n\u202f=\u202f29, Glassia; n\u202f=\u202f12, Prolastin']","['Glassia (n\u202f=\u202f33) or Prolastin', 'Glassia® (Baxalta US Inc. Westlake Village, CA, USA) and Prolastin®', 'alpha 1 -proteinase inhibitor (Glassia®']","['geometric mean ratios (GMRs) of plasma trough levels (Glassia/Prolastin', 'plasma antigenic and functional A1PI trough concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221757', 'cui_str': 'Alpha-1-antitrypsin deficiency'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2920217', 'cui_str': 'Glassia'}, {'cui': 'C0701947', 'cui_str': 'Prolastin'}]","[{'cui': 'C2920217', 'cui_str': 'Glassia'}, {'cui': 'C0701947', 'cui_str': 'Prolastin'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2920217', 'cui_str': 'Glassia'}, {'cui': 'C0701947', 'cui_str': 'Prolastin'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",50.0,0.22896,"For antigenic A1PI, the GMR (90% CI) was 115.8% (108.1-124.2) for baseline corrected and 114.2% (109.2-119.5) for uncorrected concentrations.","[{'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Takeda Development Center Americas, Inc., 650 East Kendall Street, Cambridge, MA, 02142, USA. Electronic address: zhaoyang.li@takeda.com.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Franke', 'Affiliation': 'Cognigen, SimulationsPlus Company, 1780 Wehrle Drive, Suite 110, Buffalo, NY, 14221-7000, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Morris', 'Affiliation': 'Cognigen, SimulationsPlus Company, 1780 Wehrle Drive, Suite 110, Buffalo, NY, 14221-7000, USA.'}, {'ForeName': 'Leman', 'Initials': 'L', 'LastName': 'Yel', 'Affiliation': 'Takeda Development Center Americas, Inc., 650 East Kendall Street, Cambridge, MA, 02142, USA.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2022.102124']
602,35320644,Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer.,"BACKGROUND


Trastuzumab emtansine is the current standard treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer whose disease progresses after treatment with a combination of anti-HER2 antibodies and a taxane.
METHODS


We conducted a phase 3, multicenter, open-label, randomized trial to compare the efficacy and safety of trastuzumab deruxtecan (a HER2 antibody-drug conjugate) with those of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. The primary end point was progression-free survival (as determined by blinded independent central review); secondary end points included overall survival, objective response, and safety.
RESULTS


Among 524 randomly assigned patients, the percentage of those who were alive without disease progression at 12 months was 75.8% (95% confidence interval [CI], 69.8 to 80.7) with trastuzumab deruxtecan and 34.1% (95% CI, 27.7 to 40.5) with trastuzumab emtansine (hazard ratio for progression or death from any cause, 0.28; 95% CI, 0.22 to 0.37; P<0.001). The percentage of patients who were alive at 12 months was 94.1% (95% CI, 90.3 to 96.4) with trastuzumab deruxtecan and 85.9% (95% CI, 80.9 to 89.7) with trastuzumab emtansine (hazard ratio for death, 0.55; 95% CI, 0.36 to 0.86; prespecified significance boundary not reached). An overall response (a complete or partial response) occurred in 79.7% (95% CI, 74.3 to 84.4) of the patients who received trastuzumab deruxtecan and in 34.2% (95% CI, 28.5 to 40.3) of those who received trastuzumab emtansine. The incidence of drug-related adverse events of any grade was 98.1% with trastuzumab deruxtecan and 86.6% with trastuzumab emtansine, and the incidence of drug-related adverse events of grade 3 or 4 was 45.1% and 39.8%, respectively. Adjudicated drug-related interstitial lung disease or pneumonitis occurred in 10.5% of the patients in the trastuzumab deruxtecan group and in 1.9% of those in the trastuzumab emtansine group; none of these events were of grade 4 or 5.
CONCLUSIONS


Among patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane, the risk of disease progression or death was lower among those who received trastuzumab deruxtecan than among those who received trastuzumab emtansine. Treatment with trastuzumab deruxtecan was associated with interstitial lung disease and pneumonitis. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Breast03 ClinicalTrials.gov number, NCT03529110.).",2022,"The incidence of drug-related adverse events of any grade was 98.1% with trastuzumab deruxtecan and 86.6% with trastuzumab emtansine, and the incidence of drug-related adverse events of grade 3 or 4 was 45.1% and 39.8%, respectively.","['Breast Cancer', 'patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer', 'patients with HER2-positive metastatic breast cancer previously treated with']","['Trastuzumab emtansine', 'trastuzumab and a taxane', 'trastuzumab emtansine', 'Trastuzumab Deruxtecan versus Trastuzumab Emtansine', 'trastuzumab deruxtecan', 'trastuzumab deruxtecan (a HER2 antibody-drug conjugate']","['interstitial lung disease and pneumonitis', 'incidence of drug-related adverse events', 'overall survival, objective response, and safety', 'efficacy and safety', 'progression-free survival', 'alive without disease progression', 'interstitial lung disease or pneumonitis', 'overall response']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C4704928', 'cui_str': 'Antibody-Drug Conjugates'}]","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",524.0,0.434841,"The incidence of drug-related adverse events of any grade was 98.1% with trastuzumab deruxtecan and 86.6% with trastuzumab emtansine, and the incidence of drug-related adverse events of grade 3 or 4 was 45.1% and 39.8%, respectively.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Wei-Pang', 'Initials': 'WP', 'LastName': 'Chung', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Min Hwan', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Ling-Ming', 'Initials': 'LM', 'LastName': 'Tseng', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Petry', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Chi-Feng', 'Initials': 'CF', 'LastName': 'Chung', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Chiun-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Jee Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Joanne W Y', 'Initials': 'JWY', 'LastName': 'Chiu', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Jose Luiz', 'Initials': 'JL', 'LastName': 'Pedrini', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Cathcart', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Emarjola', 'Initials': 'E', 'LastName': 'Bako', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'From the International Breast Cancer Center, Quirónsalud Group, Barcelona, the Scientific Department, Medica Scientia Innovation Research, Valencia, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid - all in Spain (J. Cortés); Asan Medical Center, University of Ulsan College of Medicine, Ulsan (S.-B.K.), Seoul National University Hospital, Cancer Research Institute (S.-A.I.), and Seoul National University Bundang Hospital (J.H.K.), Seoul National University College of Medicine, and Samsung Medical Center (Y.H.P.), Seoul, and Severance Hospital, Yonsei University, Yonsei (M.H.K.) - all in South Korea; the Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (W.-P.C.), and the Department of Surgery, Taipei Veterans General Hospital, College of Medicine, National Yang-Ming Chiao Tung University (L.-M.T.), Koo Foundation Sun Yat-Sen Cancer Center (C.-F.C.), and National Taiwan University Hospital and National Taiwan University College of Medicine (C.-S.H.), Taipei - all in Taiwan; Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária (R.H.) and Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (V.P.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (J.L.P.) - all in Brazil; Aichi Cancer Center Hospital, Aichi, Japan (H.I.); Sarah Cannon Research Institute, Tennessee Oncology, Nashville (E.H.); the Department of Oncology and Hematology-Oncology, University of Milan, and the Division of Early Drug Development, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico - both in Milan (G.C.); the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the University of Hong Kong, Hong Kong (J.W.Y.C.); Daiichi Sankyo, Basking Ridge, NJ (C.L., Y.L., J. Cathcart, E.B.); AstraZeneca, Gaithersburg, MD (S.V.); and the David Geffen School of Medicine and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles (S.A.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2115022']
603,35290152,"A phase I randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a live-attenuated quadrivalent dengue vaccine in flavivirus-naïve and flavivirus-experienced healthy adults.","Dengue (DENV) is a mosquito-borne virus with four serotypes causing substantial morbidity in tropical and subtropical areas worldwide. V181 is an investigational, live, attenuated, quadrivalent dengue vaccine. In this phase 1 double-blind, placebo-controlled study, the safety, tolerability, and immunogenicity of V181 in baseline flavivirus-naïve (BFN) and flavivirus-experienced (BFE) healthy adults were evaluated in two formulations: TV003 and TV005. TV005 contains a 10-fold higher DENV2 level than TV003. Two-hundred adults were randomized 2:2:1 to receive TV003, TV005, or placebo on Days 1 and 180. Immunogenicity against the 4 DENV serotypes was measured using a Virus Reduction Neutralization Test (VRNT 60 ) after each vaccination and out to 1 year after the second dose. There were no discontinuations due to adverse events (AE) or serious vaccine-related AEs in the study. Most common AEs after TV003 or TV005 were headache, rash, fatigue, and myalgia. Tri- or tetravalent vaccine-viremia was detected in 63.9% and 25.6% of BFN TV003 and TV005 participants, respectively, post-dose 1 (PD1). Tri- or tetravalent dengue VRNT 60  seropositivity was demonstrated in 92.6% of BFN TV003, 74.2% of BFN TV005, and 100% of BFE TV003 and TV005 participants PD1. Increases in VRNT 60  GMTs were observed after the first vaccination with TV003 and TV005 in both flavivirus subgroups for all dengue serotypes, and minimal increases were measured PD2. GMTs in the TV003 and TV005 BFE and BFN groups remained above the respective baselines and placebo through 1-year PD2. These data support further development of V181 as a single-dose vaccine for the prevention of dengue disease.",2022,GMTs in the TV003 and TV005 BFE and BFN groups remained above the respective baselines and placebo through 1-year PD2.,"['flavivirus-naïve and flavivirus-experienced healthy adults', 'Two-hundred adults']","['TV003, TV005, or placebo', 'placebo', 'live-attenuated quadrivalent dengue vaccine']","['VRNT 60  GMTs', 'Tri- or tetravalent vaccine-viremia', 'safety, tolerability, and immunogenicity', 'safety, tolerability, and immunogenicity of V181 in baseline flavivirus-naïve (BFN) and flavivirus-experienced (BFE) healthy adults', 'headache, rash, fatigue, and myalgia']","[{'cui': 'C0016215', 'cui_str': 'Flavivirus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016215', 'cui_str': 'Flavivirus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]",200.0,0.602255,GMTs in the TV003 and TV005 BFE and BFN groups remained above the respective baselines and placebo through 1-year PD2.,"[{'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Russell', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rupp', 'Affiliation': 'Sealy Institute for Vaccine Sciences, University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Javier O', 'Initials': 'JO', 'LastName': 'Morales-Ramirez', 'Affiliation': 'Clinical Research Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Diaz-Perez', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Andrews', 'Affiliation': 'Diagnostics Research Group, San Antonio, TX, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Lee', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Tyler S', 'Initials': 'TS', 'LastName': 'Finn', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Cox', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Falk Russell', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Schaller', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Martin', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Hyatt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Gozlan-Kelner', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Androniki', 'Initials': 'A', 'LastName': 'Bili', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Beth-Ann G', 'Initials': 'BG', 'LastName': 'Coller', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2046960']
604,35290464,Empagliflozin and Decreased Risk of Nephrolithiasis: A Potential New Role for SGLT2 Inhibition?,"CONTEXT


Diabetes mellitus is a risk factor for nephrolithiasis. A recent observational study found that in patients with type 2 diabetes (T2D), SGLT2 inhibitor use was associated with a 49% lower risk of nephrolithiasis compared with GLP-1 receptor agonists.
OBJECTIVE


We examined the association between nephrolithiasis and the SGLT2 inhibitor empagliflozin, using existing data from randomized clinical trials.
METHODS


We pooled data from 15 081 T2D patients randomized to empagliflozin (n = 10 177) or placebo (n = 4904) from 20 phase I-IV trials, including the large cardiovascular outcome trial, EMPA-REG OUTCOME. Incident urinary tract stone events were captured using a predefined collection of MedRA terms. A sensitivity analysis using a narrower definition was also performed. Incidence rate ratios (IRR) and 95% CIs were calculated using the relative risk estimate, stratified by study.
RESULTS


The median exposures to study drug were 543 days (placebo) and 549 days (empagliflozin); 183 patients experienced an incident urolithiasis during follow-up (placebo, 79; empagliflozin, 104), yielding annual incidence rates of 1.01 vs 0.63 events/100 patient-years in the 2 respective groups. The IRR was 0.64 (95% CI, 0.48-0.86), in favor of empagliflozin. In the sensitivity analysis, the results were similar (IRR, 0.62 [95% CI, 0.45-0.85]).
CONCLUSION


Compared with placebo, empagliflozin therapy was associated with an approximate 40% reduced risk of urinary tract stone events in T2D patients. The underlying mechanisms are unknown but may involve altered lithogenic profile of the urine. Dedicated randomized prospective clinical trials are warranted to confirm these initial observations in patients with and without T2D.",2022,"Compared to placebo, empagliflozin therapy was associated with an approximate 40% reduced risk of urinary tract stone events in T2D patients.","['T2D patients', 'patients with and without T2D']","['placebo', 'SGLT2 inhibitor', 'T2D', 'empagliflozin', 'placebo, empagliflozin', 'SGLT2 inhibitor empagliflozin', 'Empagliflozin']","['Incident urinary tract stone events', 'risk of urinary tract stone events', 'incident urolithiasis', 'risk of nephrolithiasis', 'Incidence rate ratios (IRR) and 95% confidence intervals (CI']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]",15081.0,0.28926,"Compared to placebo, empagliflozin therapy was associated with an approximate 40% reduced risk of urinary tract stone events in T2D patients.","[{'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Balasubramanian', 'Affiliation': 'Section of Endocrinology and Metabolism, Yale School of Medicine, New Haven, CT 06520-8056, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg 97080, Germany.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique Inserm CIC-P 1433, 54500 Nancy, France Inserm U1116, CHRU Nancy Brabois, France.""}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, 1383 Asker, Norway.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Elsaesser', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH &Co KG, 55218 Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON M5G 1X5, Canada.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology and Metabolism, Yale School of Medicine, New Haven, CT 06520-8056, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac154']
605,35294738,Superior Bioavailability of a Novel Curcumin Formulation in Healthy Humans Under Fasting Conditions.,"BACKGROUND


Despite its broad range of biological activities, use of curcumin is limited because of poor bioavailability. Here we report a novel curcumin formulation, Curcuwin Ultra+ (CU+), with superior bioavailability as compared to 95% turmeric extract (TUR 1800).
METHODS


A randomized, double-blind, three-treatment, crossover oral bioavailability study was conducted in 24 healthy volunteers under fasting conditions. Subjects received a single dose of CU+ 250 mg, 500 mg and 1900 mg of TUR1800 as per randomization schedule and blood samples were collected at 4 h and 0 h before dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post dose. Total curcuminoids were measured as curcumin, demethoxycurcumin, bisdemethoxycurcumin, and tetrahydrocurcumin using a validated LC-MS/MS method.
RESULTS


CU+ achieved a significantly higher (p < 0.05) maximum plasma concentration (C max ) and total systemic exposure (AUC 0-6  and AUC 0-12 ) for total curcuminoids as compared to TUR 1800. We observed 101 and 100 times higher C max  respectively for 250 and 500 mg doses of CU+ as compared to 1900 mg of TUR1800. Similarly, AUC 0-6  was 144 and 149 times higher whereas AUC 0-12  was 99 and 113 times higher respectively for 250 and 500 mg doses of CU+ as compared to 1900 mg dose of TUR1800. Further, CU+ showed 40% faster absorption (p < 0.05). No safety issues were observed.
CONCLUSION


CU+, which is designed for increased absorption and protection of curcuminoids from intestinal degradation, demonstrated superior bioavailability as compared to TUR1800 at considerably smaller doses. Additional clinical studies will help to demonstrate the impact of its increased bioavailability on efficacy.
CLINICAL TRIAL REGISTRATION


CTRI/2020/10/028508 (Clinical Trials Registry-India).",2022,"RESULTS


CU+ achieved a significantly higher (p < 0.05) maximum plasma concentration (C max ) and total systemic exposure (AUC 0-6  and AUC 0-12 ) for total curcuminoids as compared to TUR 1800.","['Healthy Humans Under Fasting Conditions', '24 healthy volunteers under fasting conditions']","['Curcuwin Ultra+ (CU', 'Novel Curcumin Formulation', 'TUR1800', 'CU', 'CU+\xa0250\xa0mg, 500\xa0mg and 1900\xa0mg of TUR1800']","['maximum plasma concentration (C max ) and total systemic exposure', 'Total curcuminoids']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",24.0,0.151507,"RESULTS


CU+ achieved a significantly higher (p < 0.05) maximum plasma concentration (C max ) and total systemic exposure (AUC 0-6  and AUC 0-12 ) for total curcuminoids as compared to TUR 1800.","[{'ForeName': 'Sudhakar', 'Initials': 'S', 'LastName': 'Kothaplly', 'Affiliation': 'ClinSync Clinical Research Pvt. Ltd., JSR Mall, Plot No. 7 to 18, Survey # 225, Opposite Mythri Nagar, Madinaguda, Hyderabad, Telangana, 500 050, India.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Alukapally', 'Affiliation': 'ClinSync Clinical Research Pvt. Ltd., JSR Mall, Plot No. 7 to 18, Survey # 225, Opposite Mythri Nagar, Madinaguda, Hyderabad, Telangana, 500 050, India.'}, {'ForeName': 'Nagaraju', 'Initials': 'N', 'LastName': 'Nagula', 'Affiliation': 'ClinSync Clinical Research Pvt. Ltd., JSR Mall, Plot No. 7 to 18, Survey # 225, Opposite Mythri Nagar, Madinaguda, Hyderabad, Telangana, 500 050, India.'}, {'ForeName': 'Rambabu', 'Initials': 'R', 'LastName': 'Maddela', 'Affiliation': 'ClinSync Clinical Research Pvt. Ltd., JSR Mall, Plot No. 7 to 18, Survey # 225, Opposite Mythri Nagar, Madinaguda, Hyderabad, Telangana, 500 050, India. rambabu.m@clinsynccro.com.'}]",Advances in therapy,['10.1007/s12325-022-02081-w']
606,35294706,Local Housing Choice Voucher Distribution Policies Impact Healthcare Utilization: a Randomized Natural Experiment.,"While associations between obtaining affordable housing and improved health care are well documented, insufficient funding often forces housing authorities to prioritize limited housing vouchers to specific populations. We assessed the impact of obtaining housing on health care utilization at two urban housing authorities with different distribution policies: Housing Authority A prioritized seniors and people with disabilities, while Housing Authority B prioritized medically complex individuals and families with school-aged children. Both housing authorities used random selection to distribute vouchers, allowing us to conduct a randomized natural experiment of cases and waitlisted controls. No significant demographic differences were present between those receiving vouchers and waitlisted controls. Housing Authority A vouchers were associated with increased outpatient visits (OR = 1.19; P = 0.051). Housing Authority B vouchers decreased the likelihood of emergency department visits (OR = 0.61; P = 0.042). This study provides evidence that, while obtaining housing can result in better health care outcomes overall, local prioritization policies can influence that impact.",2022,A vouchers were associated with increased outpatient visits (OR = 1.19; P = 0.051).,"['Housing Authority A prioritized seniors and people with disabilities, while Housing Authority B prioritized medically complex individuals and families with school-aged children', 'two urban housing authorities with different distribution policies', 'Housing Authority']",[],"['outpatient visits', 'likelihood of emergency department visits']","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557124', 'cui_str': 'Family with school-aged children'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]",[],"[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]",,0.0369211,A vouchers were associated with increased outpatient visits (OR = 1.19; P = 0.051).,"[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cohen-Cline', 'Affiliation': 'Providence Health System: Providence Health and Services, Portland, USA. Hannah.Cohen-Cline@providence.org.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Providence Health System: Providence Health and Services, Portland, USA.'}, {'ForeName': 'Keri B', 'Initials': 'KB', 'LastName': 'Vartanian', 'Affiliation': 'Providence Health System: Providence Health and Services, Portland, USA.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-022-00609-7']
607,35297659,Effects of Acute Triiodothyronine Treatment in Patients with Anterior Myocardial Infarction Undergoing Primary Angioplasty: Evidence from a Pilot Randomized Clinical Trial (ThyRepair Study).,"Background:  Thyroid hormone has a differential action on healthy and ischemic heart. Triiodothyronine (T3) administration improved postischemic cardiac function while it limited apoptosis in experimentally induced ischemia. Thus, the present study investigated the potential effects of acute liothyronine (LT3) treatment in patients with anterior myocardial infarction.  Methods:  This study is a pilot, randomized, double-blind, placebo-controlled trial (ThyRepair study). We randomized 52 patients and analyzed data from 37 patients ( n  = 16 placebo and  n  = 21 LT3), per prespecified per protocol analysis. We excluded three patients who had died of cardiovascular causes (one in placebo and two in LT3 arm), four with small infarct size below a pre-specified threshold (in the placebo arm), and the rest, who lacked follow-up data. LT3 treatment started after stenting as an intravenous (i.v.) bolus injection of 0.8 μg/kg of LT3 followed by a constant infusion of 0.113 μg/kg/h i.v. for 48 hours. All patients had cardiac magnetic resonance (CMR) at hospital discharge and 6 months follow-up. The primary end point was CMR left ventricular (LV) ejection fraction (LVEF) and secondary endpoints were LV volumes, infarct volume (IV), and safety.  Results:  The CMR LVEF% at 6 months was 53.6 ± 9.5 for the LT3-treated group and 48.6 ± 11 for placebo,  p  = 0.15. Acute LT3 treatment resulted in a significantly lower LV end-diastolic volume index (92.2 ± 16.8 mL/m 2  vs. 107.5 ± 22.2,  p  = 0.022) and LV systolic volume index (47.5 ± 13.9 mL/m 2  vs. 61.3 ± 21.7,  p  = 0.024) at hospital discharge, but not at 6 months. There was no statistically significant difference in CMR IV at hospital discharge between the groups ( p  = 0.24). CMR IV tended to be lower in the LT3-treated group at 6 months (18.7 ± 9.5 vs. 25.9 ± 11.7, in placebo,  p  = 0.05). Serious, life-threatening events related to LT3 treatment were not observed. A tendency for an increased incidence of atrial fibrillation (AF) was found in the LT3 group during the first 48 hours (19% for T3 group vs. 5% for placebo,  p  = 0.13).  Conclusion:  This pilot randomized, placebo-controlled trial study suggests potential favorable effects (acute cardiac dilatation and 6-month IV) as well as potential concerns regarding a higher risk of AF after LT3 administration early after myocardial infarction, which should be tested in a larger scale study.",2022,There was no statistically significant difference in CMR infarct volume at hospital discharge between the groups (p=0.24).,"['52 patients and analyzed data from 37 patients (n=16 placebo and n=21 LT3), per pre-specified per protocol analysis', 'patients with anterior myocardial infarction undergoing primary angioplasty', '3 patients who died of cardiovascular causes (1 in placebo and 2 in LT3 arm), 4 with small infarct size below a pre-specified threshold (in the placebo arm) and the rest, who lacked follow-up data', 'patients with anterior myocardial infarction', 'healthy and ischemic heart', 'All patients had cardiac magnetic resonance (CMR) at hospital discharge and 6 months follow-up']","['placebo', 'acute triiodothyronine treatment', 'LT3', 'Triiodothyronine', 'acute liothyronine (LT3']","['postischemic cardiac function', 'CMR infarct volume', 'incidence of atrial fibrillation', 'LV end-diastolic volume index', 'CMR LVEF', 'LV systolic volume index', 'CMR left ventricular (LV) ejection fraction (LVEF) and secondary endpoints were LV volumes, infarct volume (IV) and safety', 'CMR infarct volume at hospital discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0340293', 'cui_str': 'Myocardial Infarction, Anterior Wall'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",52.0,0.321777,There was no statistically significant difference in CMR infarct volume at hospital discharge between the groups (p=0.24).,"[{'ForeName': 'Constantinos I', 'Initials': 'CI', 'LastName': 'Pantos', 'Affiliation': 'Department of Pharmacology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athanasios G', 'Initials': 'AG', 'LastName': 'Trikas', 'Affiliation': 'Department of Cardiology, ELPIS General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Evangelos G', 'Initials': 'EG', 'LastName': 'Pissimisis', 'Affiliation': 'Department of Cardiology, Tzaneio General Hospital of Piraeus, Athens, Greece.'}, {'ForeName': 'Konstantinos P', 'Initials': 'KP', 'LastName': 'Grigoriou', 'Affiliation': 'Department of Cardiology, ELPIS General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Pavlos N', 'Initials': 'PN', 'LastName': 'Stougiannos', 'Affiliation': 'Department of Cardiology, ELPIS General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Antonios K', 'Initials': 'AK', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Cardiology, Tzaneio General Hospital of Piraeus, Athens, Greece.'}, {'ForeName': 'Sarantos I', 'Initials': 'SI', 'LastName': 'Linardakis', 'Affiliation': 'Department of Cardiology, Tzaneio General Hospital of Piraeus, Athens, Greece.'}, {'ForeName': 'Nikolaos A', 'Initials': 'NA', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Radiology, IASO Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Costas G', 'Initials': 'CG', 'LastName': 'Evdoridis', 'Affiliation': 'Department of Cardiology, ELPIS General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Gerasimos D', 'Initials': 'GD', 'LastName': 'Gavrielatos', 'Affiliation': 'Department of Cardiology, ELPIS General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Nikolaos G', 'Initials': 'NG', 'LastName': 'Patsourakos', 'Affiliation': 'Department of Cardiology, Tzaneio General Hospital of Piraeus, Athens, Greece.'}, {'ForeName': 'Nikolaos D', 'Initials': 'ND', 'LastName': 'Papakonstantinou', 'Affiliation': 'Department of Cardiology, Tzaneio General Hospital of Piraeus, Athens, Greece.'}, {'ForeName': 'Anastasios D', 'Initials': 'AD', 'LastName': 'Theodosis-Georgilas', 'Affiliation': 'Department of Cardiology, Tzaneio General Hospital of Piraeus, Athens, Greece.'}, {'ForeName': 'Iordanis S', 'Initials': 'IS', 'LastName': 'Mourouzis', 'Affiliation': 'Department of Pharmacology, National and Kapodistrian University of Athens, Athens, Greece.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2021.0596']
608,35554586,Combining cardiac monitoring with actigraphy aids nocturnal arousal detection during ambulatory sleep assessment in insomnia.,"STUDY OBJECTIVES


The objective assessment of insomnia has remained difficult. Multisensory devices collecting heart rate (HR) and motion are regarded as the future of ambulatory sleep monitoring. Unfortunately, reports on altered average HR or heart rate variability (HRV) during sleep in insomnia are equivocal. Here, we evaluated whether the objective quantification of insomnia improves by assessing state-related changes in cardiac measures.
METHODS


We recorded electrocardiography, posture, and actigraphy in 33 people without sleep complaints and 158 patients with mild to severe insomnia over 4 d in their home environment. At the microscale, we investigated whether HR changed with proximity to gross (body) and small (wrist) movements at nighttime. At the macroscale, we calculated day-night differences in HR and HRV measures. For both timescales, we tested whether outcome measures were related to insomnia diagnosis and severity.
RESULTS


At the microscale, an increase in HR was often detectable already 60 s prior to as well as following a nocturnal chest, but not wrist, movement. This increase was slightly steeper in insomnia and was associated with insomnia severity, but future EEG recordings are necessary to elucidate whether these changes occur prior to or simultaneously with PSG-indicators of wakefulness. At the macroscale, we found an attenuated cardiac response to sleep in insomnia: patients consistently showed smaller day-night differences in HR and HRV.
CONCLUSIONS


Incorporating state-related changes in cardiac features in the ambulatory monitoring of sleep might provide a more sensitive biomarker of insomnia than the use of cardiac activity averages or actigraphy alone.",2022,"At the macroscale, we found an attenuated cardiac response to sleep in insomnia: patients consistently showed smaller day-night differences in HR and HRV.
","['insomnia', '33 people without sleep complaints and 158 patients with mild to severe insomnia over 4 d in their home environment']",['actigraphy aids nocturnal arousal detection'],"['HR changed with proximity to gross (body) and small (wrist) movements at nighttime', 'insomnia diagnosis and severity', 'average HR or heart rate variability (HRV', 'HR']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",33.0,0.0175686,"At the macroscale, we found an attenuated cardiac response to sleep in insomnia: patients consistently showed smaller day-night differences in HR and HRV.
","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Rösler', 'Affiliation': 'Netherlands Institute for Neuroscience, Department of Sleep and Cognition, Amsterdam, The Netherlands.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'van der Lande', 'Affiliation': 'Netherlands Institute for Neuroscience, Department of Sleep and Cognition, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Leerssen', 'Affiliation': 'Netherlands Institute for Neuroscience, Department of Sleep and Cognition, Amsterdam, The Netherlands.'}, {'ForeName': 'Austin G', 'Initials': 'AG', 'LastName': 'Vandegriffe', 'Affiliation': 'Department of Mathematics and Statistics, Missouri University of Science and Technology, Rolla, MO,USA.'}, {'ForeName': 'Oti', 'Initials': 'O', 'LastName': 'Lakbila-Kamal', 'Affiliation': 'Netherlands Institute for Neuroscience, Department of Sleep and Cognition, Amsterdam, The Netherlands.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Foster-Dingley', 'Affiliation': 'Netherlands Institute for Neuroscience, Department of Sleep and Cognition, Amsterdam, The Netherlands.'}, {'ForeName': 'Anne C W', 'Initials': 'ACW', 'LastName': 'Albers', 'Affiliation': 'Netherlands Institute for Neuroscience, Department of Sleep and Cognition, Amsterdam, The Netherlands.'}, {'ForeName': 'Eus J W', 'Initials': 'EJW', 'LastName': 'van Someren', 'Affiliation': 'Netherlands Institute for Neuroscience, Department of Sleep and Cognition, Amsterdam, The Netherlands.'}]",Sleep,['10.1093/sleep/zsac031']
609,35311346,Cost-Effectiveness of a Household Salt Substitution Intervention: Findings From 20 995 Participants of the Salt Substitute and Stroke Study.,"BACKGROUND


SSaSS (Salt Substitute and Stroke Study), a 5-year cluster randomized controlled trial, demonstrated that replacing regular salt with a reduced-sodium, added-potassium salt substitute reduced the risks of stroke, major adverse cardiovascular events, and premature death among individuals with previous stroke or uncontrolled high blood pressure living in rural China. This study assessed the cost-effectiveness profile of the intervention.
METHODS


A within-trial economic evaluation of SSaSS was conducted from the perspective of the health care system and consumers. The primary health outcome assessed was stroke. We also quantified the effect on quality-adjusted life-years (QALYs). Health care costs were identified from participant health insurance records and the literature. All costs (in Chinese yuan [¥]) and QALYs were discounted at 5% per annum. Incremental costs, stroke events averted, and QALYs gained were estimated using bivariate multilevel models.
RESULTS


Mean follow-up of the 20 995 participants was 4.7 years. Over this period, replacing regular salt with salt substitute reduced the risk of stroke by 14% (rate ratio, 0.86 [95% CI, 0.77-0.96];  P =0.006), and the salt substitute group had on average 0.054 more QALYs per person. The average costs (¥1538 for the intervention group and ¥1649 for the control group) were lower in the salt substitute group (¥110 less). The intervention was dominant (better outcomes at lower cost) for prevention of stroke as well as for QALYs gained. Sensitivity analyses showed that these conclusions were robust, except when the price of salt substitute was increased to the median and highest market prices identified in China. The salt substitute intervention had a 95.0% probability of being cost-saving and a >99.9% probability of being cost-effective.
CONCLUSIONS


Replacing regular salt with salt substitute was a cost-saving intervention for the prevention of stroke and improvement of quality of life among SSaSS participants.",2022,"1,649 for the control group) were lower in the salt substitute group","['20,995 Participants of the Salt Substitute and Stroke Study (SSaSS', 'individuals with prior stroke or uncontrolled high blood pressure living in rural China']","['CNY', 'regular salt with salt substitute', 'Household Salt Substitution Intervention', 'salt substitute group', 'CNY ¥', 'replacing regular salt with a reduced-sodium added-potassium salt substitute', 'SSaSS']","['Healthcare costs', 'risk of stroke', 'average costs (CNY ¥', 'Cost-effectiveness', 'quality of life', 'quality-adjusted life years (QALYs', 'Incremental costs, stroke events averted, and QALYs gained', 'risks of stroke, major adverse cardiovascular events and premature death']","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1855073', 'cui_str': 'Premature Mortality'}]",20995.0,0.0847937,"1,649 for the control group) were lower in the salt substitute group","[{'ForeName': 'Ka-Chun', 'Initials': 'KC', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Maoyi', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Di Tanna', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China (X.Z., Z.H., L.L.Y., Y.W.).'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Yishu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Hao', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China (X.Z., Z.H., L.L.Y., Y.W.).'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'First Hospital of China Medical University, Shenyang, China (B.Z.).'}, {'ForeName': 'Xiangxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Changzhi Medical College, China (X.F., Z.L.).'}, {'ForeName': 'Zhifang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Changzhi Medical College, China (X.F., Z.L.).'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Center for Disease Control of Hebei, Shijiazhuang, China (J.Z., J.S.).'}, {'ForeName': 'Jixin', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Center for Disease Control of Hebei, Shijiazhuang, China (J.Z., J.S.).'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Ningxia Medical University, Yinchuan, China (Y. Zhang, Y. Zhao).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Ningxia Medical University, Yinchuan, China (Y. Zhang, Y. Zhao).'}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Jiaotong University School of Medicine, Xi'an, China (R.Z., Y.Y.).""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Xi'an Jiaotong University School of Medicine, Xi'an, China (R.Z., Y.Y.).""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Lijing L', 'Initials': 'LL', 'LastName': 'Yan', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China (X.Z., Z.H., L.L.Y., Y.W.).'}, {'ForeName': 'Darwin R', 'Initials': 'DR', 'LastName': 'Labarthe', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL (D.R.L.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Elliott', 'Affiliation': 'School of Public Health, Imperial College London, United Kingdom (P.E., B.N.).'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China (X.Z., Z.H., L.L.Y., Y.W.).'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia (K.-C.L., L.H., M.T., G.L.D.T., J.Y., X.Y., Y.L., N.L., B.N., T.L., L.S.).'}]",Circulation,['10.1161/CIRCULATIONAHA.122.059573']
610,35312968,Systemic Bioavailability of Sublingual Atropine Ophthalmic Solution: a Phase I Study in Healthy Volunteers with Implications for Use as a Contingency Medical Countermeasure.,"INTRODUCTION


Atropine sulfate is an FDA-approved medical countermeasure (MCM) for the treatment of organophosphorus nerve agent and organophosphate pesticide toxicity. Sufficient MCM supplies must be available in an incident involving a mass human exposure either from an accidental chemical release or a terrorist attack.
METHODS


We performed a randomized, 3-sequence, 3-period phase I crossover study to assess the bioavailability and pharmacokinetics (PK) of a single dose (0.5 mg and 1.0 mg) of 1% ophthalmic atropine sulfate solution administered sublingually to 15 healthy adult volunteers. The primary endpoint was evaluation of the bioavailability of each of the two sublingual doses against a 1.0 mg reference intravenous (IV) atropine dose. Secondary endpoints included the safety and tolerability (xerostomia scale) of atropine sulfate administered sublingually.
RESULTS


Sublingual atropine was safe (no severe AEs or SAEs were reported with either dose) and well tolerated, with a single subject reaching maximum xerostomia on a single dosing day. The geometric mean AUC ∞  was 286.40, 493.81, and 816.47 min*ng/mL for the 0.5 mg and 1.0 mg sublingual doses, and the 1.0 mg IV dose, respectively. Compared to IV administration, the 1.0 mg sublingual dose produced 0.60 (90% CI: 0.55-0.66) of the overall concentration of atropine over time (AUC ∞ ).
CONCLUSION


Sublingual atropine sulfate 1% ophthalmic solution may be an alternative formulation and route of administration combination which expands the capacity and dosing options of atropine as a nerve agent MCM.",2022,"Secondary endpoints included the safety and tolerability (xerostomia scale) of atropine sulfate administered sublingually.
","['Healthy Volunteers with Implications for Use as a Contingency Medical Countermeasure', '15 healthy adult volunteers']","['Sublingual atropine sulfate', 'Atropine sulfate', 'Sublingual atropine', 'ophthalmic atropine sulfate solution', 'atropine', 'Sublingual Atropine Ophthalmic Solution']","['bioavailability', 'bioavailability and pharmacokinetics (PK', 'safety and tolerability (xerostomia scale) of atropine sulfate administered sublingually', 'Systemic Bioavailability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4704836', 'cui_str': 'Medical Countermeasures'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0596005', 'cui_str': 'Atropine sulfate'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1244998', 'cui_str': 'Atropine Ophthalmic Solution'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0596005', 'cui_str': 'Atropine sulfate'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",15.0,0.0646326,"Secondary endpoints included the safety and tolerability (xerostomia scale) of atropine sulfate administered sublingually.
","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schwartz', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA. Michael.schwartz@hhs.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Raulli', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Judith W', 'Initials': 'JW', 'LastName': 'Laney', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Coley', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Anna W', 'Initials': 'AW', 'LastName': ""O'Rourke"", 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Raine', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Horwith', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Derek L', 'Initials': 'DL', 'LastName': 'Eisnor', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Wolling', 'Affiliation': 'Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), 200 C St., SW, Washington, DC, 20024, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'David', 'Affiliation': 'Rho Federal Systems Division, Inc., 2635 E NC Highway 54, Durham, NC, 27713-2230, USA.'}, {'ForeName': 'Keli', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'Rho Federal Systems Division, Inc., 2635 E NC Highway 54, Durham, NC, 27713-2230, USA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Rho Federal Systems Division, Inc., 2635 E NC Highway 54, Durham, NC, 27713-2230, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Rho Federal Systems Division, Inc., 2635 E NC Highway 54, Durham, NC, 27713-2230, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Jepson', 'Affiliation': 'Rho Federal Systems Division, Inc., 2635 E NC Highway 54, Durham, NC, 27713-2230, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fein', 'Affiliation': 'High Point Clinical Trials Center, 4160 Mendenhall Oaks Pkwy #105, High Point, NC, 27265, USA.'}]",Journal of medical toxicology : official journal of the American College of Medical Toxicology,['10.1007/s13181-021-00873-0']
611,35315622,Amino acids versus magnesium sulfate infusion for controlling postoperative shivering in patients undergoing percutaneous nephrolithotomy surgery: a randomized clinical trial.,"BACKGROUND


General anesthetics disrupt the thermoregulatory mechanisms by reducing vasoconstriction and shivering thresholds. Postoperative shivering is a challenging anesthesia-related complication with an incidence range of 20-70%. Amino acids that induce thermogenesis and magnesium sulfate are centrally acting mechanisms that could minimize shivering. Thus, this trial was designed to compare the effect of amino acid versus magnesium sulfate infusion on postoperative shivering in patients undergoing elective percutaneous nephrolithotomy (PCNL) surgery under general anesthesia.
METHODS


Eighty adults, American Society of Anesthesiologists I and II patients, were randomly assigned into one of two groups. Group A received general anesthesia and perioperative IV amino acid infusion. Group M received general anesthesia and perioperative IV magnesium sulfate infusion.
RESULTS


There was a statistically significant difference in shivering score, which was lower in group A than M (0.8±1.1 versus 1.5±1.3; P value=0.01). The incidence of postoperative shivering was lower in group A (4 [10%]) versus (11 [27.5%]) in group M. A less decrease in the core intraoperative temperature (Celsius) was observed in group A than in group M (35.5±0.2 versus 35.1±0.2; respectively, P<0.001) and at the end of surgery (36.1±0.3 versus 35.7±0.3; respectively, P<0.001).
CONCLUSIONS


Perioperative amino acids infusion is more effective and better tolerated than magnesium sulfate in preventing postoperative shivering in patients undergoing percutaneous nephrolithotomy surgery. Cost effectiveness should be kept in mind, and amino acids infusion should be reserved in high-risk surgeries for shivering.",2022,"There was a statistically significant difference in shivering score, which was lower in group A than M (0.8 ± 1.1 versus 1.5 ± 1.3; P-value= 0.01).","['patients undergoing percutaneous nephrolithotomy surgery', 'patients undergoing elective percutaneous nephrolithotomy (PCNL) surgery under general anesthesia', 'Eighty adults, American Society of Anesthesiologists I and II patients']","['general anesthesia and perioperative IV magnesium sulfate infusion', 'Amino acids versus magnesium sulfate infusion', 'amino acid versus magnesium sulfate infusion', 'magnesium sulfate', 'general anesthesia and perioperative IV amino acid infusion']","['core intraoperative temperature (Celsius', 'postoperative shivering', 'incidence of postoperative shivering', 'Cost effectiveness', 'shivering score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439237', 'cui_str': 'degrees C'}, {'cui': 'C1736186', 'cui_str': 'Postoperative shivering'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.279824,"There was a statistically significant difference in shivering score, which was lower in group A than M (0.8 ± 1.1 versus 1.5 ± 1.3; P-value= 0.01).","[{'ForeName': 'Omar M', 'Initials': 'OM', 'LastName': 'Soliman', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt - omar@aun.edu.eg.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Hamed', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Elsawy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Minerva anestesiologica,['10.23736/S0375-9393.22.16237-1']
612,35318122,Potential role for peripheral nerve stimulation on learning and long-term memory: A comparison of alternating and direct current stimulations.,"BACKGROUND


In the past decade, a rising interest in transcranial electrical stimulation has emerged owing to its advantageous capacity to facilitate the extraction of casual links between neuromodulation and the obtained behavioral effects in cognitive performance. However, an insufficient number of direct comparative studies between transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS) effects on associative memory have caused optimal parameters and procedural application to remain undefined.
OBJECTIVE


The current study aimed to comparatively investigate the effects of tDCS and tACS applied to the occipital nerve (ON), targeting the locus coeruleus, on associative memory performance.
METHODS


We employed a randomized, double-blind, two-visit, active-controlled study design. 85 cognitively normal adults were assigned to receive either active ON-tDCS, 40 Hz ON-tACS, sham ON-tDCS, or 1 Hz ON-tACS during encoding of a 50-word Swahili-English associative memory recall task. To evaluate the effects of electrical stimulation, we measured the cumulative rate of learning on Day 1 and to assess possible long-term effects, we measured the number of words recalled on Day 7.
RESULTS


Results presented two notable findings: (1) participants who received 40 Hz ON-tACS learned significantly more words on Day 1 (F 3,81  = 4.37, p = .007, η 2  = 0.14), and (2) participants who received 40 Hz ON-tACS or active ON-tDCS recalled significantly more words on Day 7 (F 3,81  = 11.08, p < .001, η 2  = 0.29).
CONCLUSIONS


The evidence from this study alludes to 40 Hz ON-tACS and active ON-tDCS inducing distinct behavioral effects, whereby 40 Hz ON-tACS generated an effect during memory encoding via enhanced attention, however, active ON-tDCS elicited an offline effect transpiring during consolidation. Further neuroimaging studies are needed to validate these findings and proposed mechanisms of action.",2022,"RESULTS


Results presented two notable findings: (1) participants who received 40 Hz ON-tACS learned significantly more words on Day 1 (F 3,81  = 4.37, p = .007, η 2  = 0.14), and (2) participants who received 40 Hz ON-tACS or active ON-tDCS recalled significantly more words on Day 7 (F 3,81  = 11.08, p < .001, η 2  = 0.29).
",['85 cognitively normal adults'],"['transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS', 'active ON-tDCS, 40\u202fHz ON-tACS, sham ON-tDCS, or 1\u202fHz ON-tACS during encoding of a 50-word Swahili-English associative memory recall task', 'tDCS and tACS']",['cumulative rate of learning'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1283707', 'cui_str': 'Occipital nerve'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0679063', 'cui_str': 'Memory recall'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",85.0,0.0707742,"RESULTS


Results presented two notable findings: (1) participants who received 40 Hz ON-tACS learned significantly more words on Day 1 (F 3,81  = 4.37, p = .007, η 2  = 0.14), and (2) participants who received 40 Hz ON-tACS or active ON-tDCS recalled significantly more words on Day 7 (F 3,81  = 11.08, p < .001, η 2  = 0.29).
","[{'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Luckey', 'Affiliation': 'Lab for Clinical & Integrative Neuroscience, School of Psychology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'S Lauren', 'Initials': 'SL', 'LastName': 'McLeod', 'Affiliation': 'School of Medicine, Texas Tech School of Medicine, Texas, USA.'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Lab for Clinical & Integrative Neuroscience, School of Psychology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Vanneste', 'Affiliation': 'Lab for Clinical & Integrative Neuroscience, School of Psychology, Trinity College Dublin, Dublin, Ireland; Global Brain Health Institute, Trinity College Dublin, Dublin, Ireland; Trinity College Institute for Neuroscience, Trinity College Dublin, Dublin, Ireland. Electronic address: sven.vanneste@tcd.ie.'}]",Brain stimulation,['10.1016/j.brs.2022.03.001']
613,35322709,Repetitive transcranial magnetic stimulation improves consciousness in some patients with disorders of consciousness.,"OBJECTIVE


To investigate the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with disorders of consciousness.
DESIGN AND SETTING


We performed a randomized, double-blinded, sham-controlled trial.
PARTICIPANTS


Patients (N = 40) with disorders of consciousness.
INTERVENTIONS


Forty patients with disorders of consciousness (time since onset of the disorder 49.0 ± 24.6 days) were enrolled and randomized to groups receiving either active-rTMS or sham-rTMS. The active-TMS protocol had a frequency of 20 Hz, was delivered over the left dorsolateral prefrontal cortex and had a 100% rest motor threshold. The sham-rTMS protocol was the same as the active protocol without magnetic stimulation over the cortex.
MAIN OUTCOME MEASURES


Consciousness was evaluated by the Coma Recovery Scale-Revised (CRS-R) before and after the four-week intervention. The ratio of patients that awakened from disorders of consciousness was followed up at discharge.
RESULTS


Before rTMS sessions, there were no significant differences in consciousness scores between groups. Compared to sham-rTMS (6.25 ± 1.29), patients with disorders of consciousness treated by active rTMS showed strikingly improved consciousness (8.45 ± 3.55). In-depth analysis revealed that only some patients showed obvious increases in consciousness scores induced by active rTMS. Furthermore, rTMS did not significantly enhance the awakening ratio.
CONCLUSIONS


rTMS showed therapeutic efficacy for improving consciousness in some, but not all, patients with disorders of consciousness. It is essential to discern the potential patients whose consciousness can be improved by rTMS.",2022,"RESULTS


Before rTMS sessions","['Patients (N\u2009=\u200940) with disorders of consciousness', 'patients with disorders of consciousness', 'Forty patients with disorders of consciousness (time since onset of the disorder 49.0\u2009±\u200924.6 days']","['Repetitive transcranial magnetic stimulation', 'active-rTMS or sham-rTMS', 'rTMS sessions', 'sham-rTMS', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['Coma Recovery Scale-Revised (CRS-R', 'consciousness', 'awakening ratio', 'consciousness scores', 'therapeutic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",40.0,0.0729999,"RESULTS


Before rTMS sessions","[{'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, 198153Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, 198153Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, 198153Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Nilubaier', 'Initials': 'N', 'LastName': 'Aierken', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, 198153Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Renhong', 'Initials': 'R', 'LastName': 'He', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, 198153Southern Medical University, Guangzhou 510515, China.'}]",Clinical rehabilitation,['10.1177/02692155221089455']
614,35325164,A Cluster Randomized Noninferiority Field Trial of Gestational Diabetes Mellitus Screening.,"CONTEXT


Although it is well-acknowledged that gestational diabetes mellitus (GDM) is associated with the increased risks of adverse pregnancy outcomes, the optimal strategy for screening and diagnosis of GDM is still a matter of debate.
OBJECTIVE


This study was conducted to demonstrate the noninferiority of less strict GDM screening criteria compared with the strict International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria with respect to maternal and neonatal outcomes.
METHODS


A cluster randomized noninferiority field trial was conducted on 35 528 pregnant women; they were scheduled to have 2 phases of GDM screening based on 5 different prespecified protocols including fasting plasma glucose in the first trimester with threshold of 5.1 mmol/L (92 mg/dL) (protocols A, D) or 5.6 mmol/L (100 mg/dL) (protocols B, C, E) and either a 1-step (GDM is defined if one of the plasma glucose values is exceeded [protocol A and C] or 2 or more exceeded values are needed [protocol B]) or 2-step approach (protocols D, E) in the second trimester. Guidelines for treatment of GDM were consistent with all protocols. Primary outcomes of the study were the prevalence of macrosomia and primary cesarean section (CS). The null hypothesis that less strict protocols are inferior to protocol A (IADPSG) was tested with a noninferiority margin effect (odds ratio) of 1.7.
RESULTS


The percentages of pregnant women diagnosed with GDM and assigned to protocols A, B, C, D, and E were 21.9%, 10.5%, 12.1%, 19.4%, and 8.1%, respectively. Intention-to-treat analyses satisfying the noninferiority of the less strict protocols of B, C, D, and E compared with protocol A. However, noninferiority was not shown for primary CS comparing protocol E with A. The odds ratios (95% CI) for macrosomia and CS were: B (1.01 [0.95-1.08]; 0.85 [0.56-1.28], C (1.03 [0.73-1.47]; 1.16 [0.88-1.51]), D (0.89 [0.68-1.17]; 0.94 [0.61-1.44]), and E (1.05 [0.65-1.69]; 1.33 [0.82-2.00]) vs A. There were no statistically significant differences in the adjusted odds of adverse pregnancy outcomes in the 2-step compared with the 1-step screening approaches, considering multiplicity adjustment.
CONCLUSIONS


The IADPSG GDM definition significantly increased the prevalence of GDM diagnosis. However, the less strict approaches were not inferior to other criteria in terms of adverse maternal and neonatal outcomes.",2022,"There were no statistically significant differences in the adjusted odds of adverse pregnancy outcomes in the two-step compared to one-step screening approaches, considering multiplicity adjustment.
","['35528 pregnant women', 'gestational diabetes mellitus screening', 'gestational diabetes mellitus (GDM']",[],"['fasting plasma glucose', 'prevalence of GDM diagnosis', 'adverse pregnancy outcomes', 'prevalence of macrosomia and primary cesarean-section (C-S']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",[],"[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",35528.0,0.198815,"There were no statistically significant differences in the adjusted odds of adverse pregnancy outcomes in the two-step compared to one-step screening approaches, considering multiplicity adjustment.
","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Ramezani Tehrani', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1985717413, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Behboudi-Gandevani', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, Bodø 8049, Norway.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Farzadfar', 'Affiliation': 'Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran 1411713139, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hosseinpanah', 'Affiliation': 'Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1985717413, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Hadaegh', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1985717413, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1985717413, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Soleymani-Dodaran', 'Affiliation': 'Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran 1445613113, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Valizadeh', 'Affiliation': 'Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1985717413, Iran.'}, {'ForeName': 'Mehrandokht', 'Initials': 'M', 'LastName': 'Abedini', 'Affiliation': 'Infertility and cell therapy office, Transplant & Disease Treatment Center, Ministry of Health and Medical Education, Tehran 1419943471, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1985717413, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Bidhendi Yarandi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran 1985713834, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Torkestani', 'Affiliation': 'Shahed University of medical Science, Tehran 3319118651, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Nutrition, Ministry of Health and Medical Education, Tehran 1419943471, UK.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Bakhshandeh', 'Affiliation': 'Family Health Department, Ministry of Health and Medical Education, Tehran 1419943471, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Zokaee', 'Affiliation': 'Population, family and school health Department, Kurdistan University of Medical Sciences, Sanandaj 6618634683, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1985717413, Iran.'}, {'ForeName': 'Farzam', 'Initials': 'F', 'LastName': 'Bidarpour', 'Affiliation': 'Kurdistan University of Medical Sciences, Sanandaj 6618634683, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Javanbakht', 'Affiliation': 'University of Southampton, Hampshire SO16 7NS, England.'}, {'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Nabipour', 'Affiliation': 'The Persian Gulf Tropical Medicine Research Center, The Persian Gulf Biomedical Sciences Research Institute, Bushehr University of Medical Sciences, Bushehr 7514763448, Iran.'}, {'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Nasli Esfahani', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran 1411713139, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Ostovar', 'Affiliation': 'Osteoporosis Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran 1985717413, Iran.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac181']
615,35325161,Quinine Effects on Gut and Pancreatic Hormones and Antropyloroduodenal Pressures in Humans-Role of Delivery Site and Sex.,"CONTEXT


The bitter substance quinine modulates the release of a number of gut and gluco-regulatory hormones and upper gut motility. As the density of bitter receptors may be higher in the duodenum than the stomach, direct delivery to the duodenum may be more potent in stimulating these functions. The gastrointestinal responses to bitter compounds may also be modified by sex.
BACKGROUND


We have characterized the effects of intragastric (IG) versus intraduodenal (ID) administration of quinine hydrochloride (QHCl) on gut and pancreatic hormones and antropyloroduodenal pressures in healthy men and women.
METHODS


14 men (26 ± 2 years, BMI: 22.2 ± 0.5 kg/m2) and 14 women (28 ± 2 years, BMI: 22.5 ± 0.5 kg/m2) received 600 mg QHCl on 2 separate occasions, IG or ID as a 10-mL bolus, in randomized, double-blind fashion. Plasma ghrelin, cholecystokinin, peptide YY, glucagon-like peptide-1 (GLP-1), insulin, glucagon, and glucose concentrations and antropyloroduodenal pressures were measured at baseline and for 120 minutes following QHCl.
RESULTS


Suppression of ghrelin (P = 0.006), stimulation of cholecystokinin (P = 0.030), peptide YY (P = 0.017), GLP-1 (P = 0.034), insulin (P = 0.024), glucagon (P = 0.030), and pyloric pressures (P = 0.050), and lowering of glucose (P = 0.001) were greater after ID-QHCl than IG-QHCl. Insulin stimulation (P = 0.021) and glucose reduction (P = 0.001) were greater in females than males, while no sex-associated effects were found for cholecystokinin, peptide YY, GLP-1, glucagon, or pyloric pressures.
CONCLUSION


ID quinine has greater effects on plasma gut and pancreatic hormones and pyloric pressures than IG quinine in healthy subjects, consistent with the concept that stimulation of small intestinal bitter receptors is critical to these responses. Both insulin stimulation and glucose lowering were sex-dependent.",2022,"Insulin stimulation (P=0.021) and glucose reduction (P=0.001) were greater in females than males, while no sex-associated effects were found for cholecystokinin, peptide-YY, GLP-1, glucagon or pyloric pressures.
","['14 men (26±2 years, BMI: 22.2±0.5 kg/m 2) and 14 women (28±2 years, BMI', 'healthy men and women', 'healthy subjects', 'humans-role of delivery site and sex']","['intragastric (IG) versus intraduodenal (ID) administration of quinine-hydrochloride (QHCl', '600mg QHCl']","['Plasma ghrelin, cholecystokinin, peptide-YY, glucagon-like peptide-1', 'glucagon', 'GLP-1', 'pyloric pressures', 'stimulation of cholecystokinin', 'plasma gut and pancreatic hormones and pyloric pressures', 'Insulin stimulation', 'GLP-1), insulin, glucagon and glucose concentrations and antropyloroduodenal pressures', 'glucose reduction', 'lowering of glucose']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C1512937', 'cui_str': 'Intraduodenal route'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0034421', 'cui_str': 'Quinine hydrochloride'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0030292', 'cui_str': 'Pancreatic hormone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",,0.11157,"Insulin stimulation (P=0.021) and glucose reduction (P=0.001) were greater in females than males, while no sex-associated effects were found for cholecystokinin, peptide-YY, GLP-1, glucagon or pyloric pressures.
","[{'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Rezaie', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide SA 5005, Australia.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Bitarafan', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide SA 5005, Australia.'}, {'ForeName': 'Braden D', 'Initials': 'BD', 'LastName': 'Rose', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide SA 5005, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide SA 5005, Australia.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide SA 5005, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide SA 5005, Australia.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac182']
616,35325149,Randomized Trial of Osilodrostat for the Treatment of Cushing Disease.,"CONTEXT


Cushing disease, a chronic hypercortisolism disorder, is associated with considerable morbidity and mortality. Normalizing cortisol production is the primary treatment goal.
OBJECTIVE


We aimed to evaluate the safety and efficacy of osilodrostat, a potent, orally available 11βhydroxylase inhibitor, compared with placebo in patients with Cushing disease.
METHODS


LINC 4 was a phase III, multicenter trial comprising an initial 12-week, randomized, double-blind, placebo-controlled (osilodrostat:placebo, 2:1) period followed by a 36-week, open-label treatment period (NCT02697734). Adult patients (aged 18-75 years) with confirmed Cushing disease and mean urinary free cortisol (mUFC) excretion ≥ 1.3 times the upper limit of normal (ULN) were eligible. The primary endpoint was the proportion of randomized patients with mUFC ≤ ULN at week 12. The key secondary endpoint was the proportion achieving mUFC ≤ ULN at week 36 (after 24 weeks' open-label osilodrostat).
RESULTS


Seventy-three patients (median age, 39 years [range, 19-67]; mean/median mUFC, 3.1 × ULN/2.5 × ULN) received randomized treatment with osilodrostat (n = 48) or placebo (n = 25). At week 12, significantly more osilodrostat (77%) than placebo (8%) patients achieved mUFC ≤ ULN (odds ratio 43.4; 95% CI 7.1, 343.2; P < 0.0001). Response was maintained at week 36, when 81% (95% CI 69.9, 89.1) of all patients achieved mUFC ≤ ULN. The most common adverse events during the placebo-controlled period (osilodrostat vs placebo) were decreased appetite (37.5% vs 16.0%), arthralgia (35.4% vs 8.0%), and nausea (31.3% vs 12.0%).
CONCLUSION


Osilodrostat rapidly normalized mUFC excretion in most patients with Cushing disease and maintained this effect throughout the study. The safety profile was favorable.",2022,"Response was maintained at week 36, when 81% (95% CI 69.9, 89.1) of all patients achieved mUFC≤ULN.","[""Cushing's disease"", ""patients with Cushing's disease"", '73 patients (median age, 39 years [range, 19-67]; mean/median mUFC, 3.1×ULN/2.5×ULN', ""Adult patients (aged 18-75 years) with confirmed Cushing's disease and mean urinary free cortisol (mUFC) excretion ≥1.3 times the upper limit of normal (ULN) were eligible""]","['placebo-controlled (osilodrostat:placebo', 'osilodrostat', 'placebo', 'placebo-controlled period (osilodrostat vs placebo']","['nausea', 'Normalizing cortisol production', 'safety and efficacy', 'osilodrostat', 'mUFC excretion', 'appetite', 'arthralgia']","[{'cui': 'C0221406', 'cui_str': 'Pituitary dependent hypercortisolism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}]",,0.419853,"Response was maintained at week 36, when 81% (95% CI 69.9, 89.1) of all patients achieved mUFC≤ULN.","[{'ForeName': 'Mônica', 'Initials': 'M', 'LastName': 'Gadelha', 'Affiliation': 'Neuroendocrinology Research Center, Endocrinology Section, Medical School and Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bex', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Feelders', 'Affiliation': 'Department of Internal Medicine, Endocrine Section, Erasmus Medical Center, Rotterdam CA, The Netherlands.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Heaney', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Auchus', 'Affiliation': 'Division of Metabolism, Endocrinology and Diabetes, Departments of Internal Medicine and Pharmacology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Gilis-Januszewska', 'Affiliation': 'Department of Endocrinology, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Witek', 'Affiliation': 'Department of Internal Medicine, Endocrinology and Diabetes, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Zhanna', 'Initials': 'Z', 'LastName': 'Belaya', 'Affiliation': 'Department of Neuroendocrinology and Bone Disease, Endocrinology Research Centre, Moscow, Russia.'}, {'ForeName': 'Yerong', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chih Hao Chen', 'Initials': 'CHC', 'LastName': 'Ku', 'Affiliation': 'Clinica Los Yoses, San Pedro, Costa Rica.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Carvalho', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Centro Hospitalar Universitário de São João, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roughton', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Wojna', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Pedroncelli', 'Affiliation': 'Recordati AG, Basel, Switzerland.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac178']
617,35296973,The Evaluation of Biomarkers of Physical Activity on Stress Resistance and Wellness.,"Physical activity can improve health as well as reduce stress and the risk of developing several widespread diseases. However, there exists no accepted standard biomedical examination-method for stress evaluation. The purpose of this study was to investigate the effect of regular physical activity on stress and wellness as well as the evaluation of potential biomarkers in this field. This study included 105 people (mean age = 36.57 ± 1.4 years) who were randomly assigned into the exercise group 1 (EG-1) (n = 41), the exercise group 2 (EG-2) (n = 30), and the control group (CG) (n = 34). Measurements of stress and wellness were obtained by Multiscan BC-OXI before and after experimental period. This device presents a multifrequency segmental body composition 3D analyser with digital pulse oximeter. The key indicators of stress as well as for wellness were significantly improved in the EG-1. Parasympathetic activity showed significant changes as potential stress biomarker. Statistically significant gender differences were not observed in the comparable groups. The results suggest that the stress resistance and well-being significantly improved in the EG-1 due to regular physical activity. However, further research is necessary to determine effects of physical activity on integral health indicators.",2022,The results suggest that the stress resistance and well-being significantly improved in the EG-1 due to regular physical activity.,['105 people (mean age = 36.57 ± 1.4\xa0years'],"['exercise group 1 (EG-1', 'exercise group 2 (EG-2', 'regular physical activity']",[],"[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],105.0,0.0148947,The results suggest that the stress resistance and well-being significantly improved in the EG-1 due to regular physical activity.,"[{'ForeName': 'Arpine', 'Initials': 'A', 'LastName': 'Muradyan', 'Affiliation': 'Department of Physical Rehabilitation, Armenian State Institute of Physical Culture and Sport, Aleq Manukyanstreet 11, Yerevan, Armenia.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Macheiner', 'Affiliation': 'International Biobanking and Education, Medical University of Graz, Elisabethstraße 38/Merangasse 11, 8010, Graz, Austria.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Mardiyan', 'Affiliation': 'Department of Public Health and Health Organization, Yerevan State Medical University, Koryun Street 2, Yerevan, Armenia.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Sekoyan', 'Affiliation': 'Department of Rehabilitation, Physiotherapy and Sports Medicine, Yerevan State Medical University, Koryun Street 2, Yerevan, Armenia.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Sargsyan', 'Affiliation': 'International Biobanking and Education, Medical University of Graz, Elisabethstraße 38/Merangasse 11, 8010, Graz, Austria. karine.sargsyan@medunigraz.at.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-022-09538-2']
618,35297288,Methodological aspects of a randomized within-patient concurrent controlled design for clinical trials in spine surgery.,"INTRODUCTION


Randomized controlled trials are considered the highest level of evidence, but their feasibility in the surgical field is severely hampered by methodological and practical issues. Concurrent comparison between the experimental and control conditions within the same patient can be an effective strategy to mitigate some of these challenges and improve generalizability, mainly by the elimination of between-patient variability and reduction of the required sample size. This article aims (1) to describe the methodological aspects of a randomized within-patient controlled trial and (2) to quantify the added value of this design, based on a recently completed randomized within-patient controlled trial on bone grafts in instrumented lumbar posterolateral spinal fusion.
METHODS


Boundary conditions for the application of the randomized within-patient controlled trial design were identified. Between-patient variability was quantified by the intraclass correlation coefficient and concordance in the primary fusion outcome. Sample size, study duration and costs were compared with a classic randomized controlled trial design.
RESULTS


Boundary conditions include the concurrent application of the experimental and control conditions to identical but physically separated sites. Moreover, the outcome of interest should be local, uncorrelated and independently assessable. The spinal fusion outcomes within a patient were found to be more similar than between different patients (intraclass correlation coefficient 32% and concordance 64%), demonstrating a clear effect of patient-related factors. The randomized within-patient controlled trial design allowed a reduction of the sample size to one-third of a parallel-group randomized controlled trial, thereby halving the trial duration and costs.
CONCLUSION


When suitable, the randomized within-patient controlled trial is an efficient design that provides a solution to some of the considerable challenges of a classic randomized controlled trial in (spine) surgery. This design holds specific promise for efficacy studies of non-active bone grafts in instrumented posterolateral fusion surgery.",2022,"The spinal fusion outcomes within a patient were found to be more similar than between different patients (intraclass correlation coefficient 32% and concordance 64%), demonstrating a clear effect of patient-related factors.","['non-active bone grafts in instrumented posterolateral fusion surgery', 'spine surgery']",[],['spinal fusion outcomes'],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}]",[],"[{'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.479483,"The spinal fusion outcomes within a patient were found to be more similar than between different patients (intraclass correlation coefficient 32% and concordance 64%), demonstrating a clear effect of patient-related factors.","[{'ForeName': 'A Mechteld', 'Initials': 'AM', 'LastName': 'Lehr', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Wilco Ch', 'Initials': 'WC', 'LastName': 'Jacobs', 'Affiliation': 'The Health Scientist, The Hague, The Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': 'Department of Data Science and Biostatistics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Castelein', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cumhur Oner', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Moyo C', 'Initials': 'MC', 'LastName': 'Kruyt', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}]","Clinical trials (London, England)",['10.1177/17407745221084705']
619,35298833,Testosterone does not affect lower urinary tract symptoms while improving markers of prostatitis in men with benign prostatic hyperplasia: a randomized clinical trial.,"PURPOSE


Benign Prostatic Hyperplasia (BPH) is a result of prostate inflammation, frequently occurring in metabolic syndrome (MetS). Low testosterone is common in MetS. A randomized clinical trial was designed to evaluate if 24 weeks of testosterone therapy (TTh) in BPH men with MetS and low testosterone improve urinary symptoms and prostate inflammation.
METHODS


One-hundred-twenty men with MetS waitlisted for BPH surgery were enrolled. They were categorized into normal testosterone (TT ≥ 12 nmol/L and cFT ≥ 225 pmol/L; n = 48) and testosterone deficient (TD) (TT < 12 nmol/L and/or cFT < 225 pmol/L; n = 72) then randomized to testosterone gel 2% (5 g/daily) or placebo for 24 weeks. At baseline and follow-up, questionnaires for urinary symptoms and trans-rectal ultrasound were performed. Prostate tissue was collected for molecular and histopathological analyses.
RESULTS


No differences in the improvement of urinary symptoms were found between TTh and placebo (OR [95% CI] 0.96 [0.39; 2.37]). In TD + TTh, increase in prostate but not adenoma volume was observed (2.64 mL [0.07; 5.20] and 1.82 mL [- 0.46; 0.41], respectively). Ultrasound markers of inflammation were improved. In a subset of 61 men, a hyper-expression of several pro-inflammatory genes was found in TD + placebo when compared with normal testosterone. TTh was able to counteract this effect. For 80 men, the inflammatory infiltrate was higher in TD + placebo than in normal testosterone (0.8 points [0.2; 1.4]) and TD + TTh men (0.9 points [0.2; 1.5]).
CONCLUSIONS


Twenty-four weeks of TTh in TD men with BPH and MetS improves ultrasound, molecular and histological proxies of prostate inflammation. This does not result in symptom improvement.",2022,No differences in the improvement of urinary symptoms were found between TTh and placebo (OR [95% CI] 0.96 [0.39; 2.37]).,"['Benign Prostatic Hyperplasia (BPH', 'One-hundred-twenty men with MetS waitlisted for BPH surgery were enrolled', 'men with benign prostatic hyperplasia', 'BPH men with MetS and low testosterone improve urinary symptoms and prostate inflammation']","['testosterone deficient (TD) (TT\u2009<\u200912\xa0nmol/L and/or cFT', 'placebo', 'Low testosterone', 'Testosterone', 'testosterone therapy (TTh', 'testosterone gel', 'normal testosterone']","['hyper-expression of several pro-inflammatory genes', 'prostate but not adenoma volume', 'urinary tract symptoms', 'improvement of urinary symptoms', 'ultrasound, molecular and histological proxies of prostate inflammation', 'inflammatory infiltrate', 'Ultrasound markers of inflammation']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0033581', 'cui_str': 'Prostatitis'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C1332833', 'cui_str': 'Calcifying fibrous tumor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0033581', 'cui_str': 'Prostatitis'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",120.0,0.336157,No differences in the improvement of urinary symptoms were found between TTh and placebo (OR [95% CI] 0.96 [0.39; 2.37]).,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rastrelli', 'Affiliation': 'Department of Experimental Clinical and Biomedical Sciences ""Mario Serio"", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cipriani', 'Affiliation': 'Department of Experimental Clinical and Biomedical Sciences ""Mario Serio"", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lotti', 'Affiliation': 'Department of Experimental Clinical and Biomedical Sciences ""Mario Serio"", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Cellai', 'Affiliation': 'Department of Experimental Clinical and Biomedical Sciences ""Mario Serio"", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Comeglio', 'Affiliation': 'Department of Experimental Clinical and Biomedical Sciences ""Mario Serio"", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Filippi', 'Affiliation': 'Interdepartmental Laboratory of Functional and Cellular Pharmacology of Reproduction, Department of Neuroscience, Psychology, Pharmacology and Child Health, University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Boddi', 'Affiliation': 'Department of Experimental Clinical and Biomedical Sciences ""Mario Serio"", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Della Camera', 'Affiliation': 'Urology Unit, Azienda Ospedaliera Universitaria Careggi, Largo Piero Palagi, 1, 50139, Florence, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Santi', 'Affiliation': 'Pathological Anatomy Unit, Careggi University Hospital, Largo Piero Palagi, 1, 50139, Florence, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Unit of Clinical Epidemiology, IRCCS Policlinico San Martino, Largo Rosanna Benzi, 10, 16132, Genoa, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nesi', 'Affiliation': 'Department of Health Sciences, University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Serni', 'Affiliation': 'Urology Unit, Azienda Ospedaliera Universitaria Careggi, Largo Piero Palagi, 1, 50139, Florence, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gacci', 'Affiliation': 'Urology Unit, Azienda Ospedaliera Universitaria Careggi, Largo Piero Palagi, 1, 50139, Florence, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maggi', 'Affiliation': 'Department of Experimental Clinical and Biomedical Sciences ""Mario Serio"", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vignozzi', 'Affiliation': 'Department of Experimental Clinical and Biomedical Sciences ""Mario Serio"", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy. linda.vignozzi@unifi.it.'}]",Journal of endocrinological investigation,['10.1007/s40618-022-01776-9']
620,35300888,Thulium Fibre Laser versus Holmium:YAG for Ureteroscopic Lithotripsy: Outcomes from a Prospective Randomised Clinical Trial.,"BACKGROUND


Holmium:yttrium-aluminium-garnet (Ho:YAG) laser is the gold standard for ureterorenoscopic (URS) lithotripsy. Thulium fibre laser (TFL) has recently been introduced as a new technology and may challenge Ho:YAG as the preferred laser owing to favourable properties as demonstrated in preclinical studies.
OBJECTIVE


To evaluate and compare outcomes after URS lithotripsy with Ho:YAG and TFL.
DESIGN, SETTING, AND PARTICIPANTS


In a prospective randomised trial, patients aged ≥18 yr with ureteral and/or renal stones (≥5 mm) scheduled to undergo day-case URS lithotripsy were invited to participate. In total, 120 consecutively admitted patients with signed consent were included for randomisation.
INTERVENTION


URS lithotripsy with Ho:YAG or TFL.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary outcome was the stone-free rate (SFR) assessed on noncontrast computed tomography at 3-mo follow-up. Secondary outcomes were the operative time and complications. Outcomes were compared between the groups using the t test and χ 2  test.
RESULTS AND LIMITATIONS


After a single session, the SFR was 67% in the Ho:YAG group and 92% in the TFL group, p = 0.001. For ureteral stones, the SFR was 100% in both groups, and for renal stones; 49% (Ho:YAG) and 86% (TFL), p = 0.001. Operative time was shorter using TFL (49 min) compared to Ho:YAG (57 min), p = 0.008. Bleeding that impaired the endoscopic view was the most frequent intraoperative adverse event and occurred in 13 patients (22%) in the Ho:YAG group and three (5%) in the TFL group, p = 0.014.
CONCLUSIONS


In this study, significantly more patients with renal stones achieved stone-free status and fewer experienced intraoperative complications using TFL compared to Ho:YAG. TFL is the emerging laser of choice for stone lithotripsy.
PATIENT SUMMARY


We compared outcomes after ureterorenoscopic treatment of kidney and ureteral stones using two different lasers. Our results show that the new thulium fibre laser technology is superior to the current standard laser (holmium:YAG) in clearing kidney stones and reducing operative complications.",2022,"Operative time was shorter using TFL (49 min) compared to Ho:YAG (57 min), p = 0.008.","['Ureteroscopic Lithotripsy', 'patients aged ≥18 yr with ureteral and/or renal stones (≥5 mm) scheduled to undergo day-case URS lithotripsy were invited to participate', '120 consecutively admitted patients with signed consent were included for randomisation']","['URS lithotripsy with Ho:YAG', 'Thulium Fibre Laser versus Holmium:YAG', 'standard laser (holmium:YAG', 'Thulium fibre laser (TFL', 'URS lithotripsy with Ho:YAG or TFL', 'Holmium:yttrium-aluminium-garnet (Ho:YAG) laser', 'YAG', 'TFL']","['operative time and complications', 'SFR', 'Operative time', 'intraoperative complications', 'stone-free rate (SFR']","[{'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}]",120.0,0.137844,"Operative time was shorter using TFL (49 min) compared to Ho:YAG (57 min), p = 0.008.","[{'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Ulvik', 'Affiliation': 'Department of Urology, Helse Bergen HF, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway. Electronic address: doc.ulvik@online.no.'}, {'ForeName': 'Mathias Sørstrand', 'Initials': 'MS', 'LastName': 'Æsøy', 'Affiliation': 'Department of Urology, Helse Bergen HF, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Juliebø-Jones', 'Affiliation': 'Department of Urology, Helse Bergen HF, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Peder', 'Initials': 'P', 'LastName': 'Gjengstø', 'Affiliation': 'Department of Urology, Helse Bergen HF, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beisland', 'Affiliation': 'Department of Urology, Helse Bergen HF, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}]",European urology,['10.1016/j.eururo.2022.02.027']
621,35305278,Heat suit training increases hemoglobin mass in elite cross-country skiers.,"PURPOSE


The primary purpose was to test the effect of heat suit training on hemoglobin mass (Hb mass  ) in elite cross-country (XC) skiers.
METHODS


Twenty-five male XC-skiers were divided into a group that added 5 × 50 min weekly heat suit training sessions to their regular training (HEAT; n = 13, 23 ± 5 years, 73.9 ± 5.2 kg, 180 ± 6 cm, 76.8 ± 4.6 ml·min -1  ·kg -1  ) or to a control group matched for training volume and intensity distribution (CON; n = 12, 23 ± 4 years, 78.4 ± 5.8 kg, 184 ± 4 cm, 75.2 ± 3.4 ml·min -1  ·kg -1  ) during the five-week intervention period. Hb mass  , endurance performance and factors determining endurance performance were assessed before and after the intervention.
RESULTS


HEAT led to 30 g greater Hb mass  (95% CI: [8.5, 51.7], p = 0.009) and 157 ml greater red blood cell volume ([29, 285], p = 0.018) post-intervention, compared to CON when adjusted for baseline values. In contrast, no group differences were observed for changes in work economy, running velocity, and fractional utilization of maximal oxygen uptake (V̇O 2max  ) at 4 mmol·L -1  blood lactate, V̇O 2max  or 15-min running distance performance trial during the intervention.
CONCLUSION


HEAT induced a larger increase in Hb mass  and red blood cell volume after five weeks with five weekly heat suit training sessions than CON, but with no detectable group differences on physiological determinants of endurance performance or actual endurance performance in elite CX skiers.",2022,"In contrast, no group differences were observed for changes in work economy, running velocity, and fractional utilization of maximal oxygen uptake (V̇O 2max  ) at 4 mmol·L -1  blood lactate, V̇O 2max  or 15-min running distance performance trial during the intervention.
","['Twenty-five male XC skiers', 'elite cross-country skiers', 'elite cross-country (XC) skiers']","['heat suit training', 'Heat suit training', 'added 5x50 min weekly heat suit training sessions to their regular training']","['Hb mass  and factors determining endurance performance and endurance performance', 'Hb mass  and red blood cell volume', 'red blood cell volume', 'physiological determinants of endurance performance or actual endurance performance', 'hemoglobin mass', 'work economy, running velocity, and fractional utilization of maximal oxygen uptake (V̇O 2max  ) at 4 mmol·L -1  blood lactate, V̇O 2max  or 15-min running distance performance trial']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0425040', 'cui_str': 'Skier'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",25.0,0.0103504,"In contrast, no group differences were observed for changes in work economy, running velocity, and fractional utilization of maximal oxygen uptake (V̇O 2max  ) at 4 mmol·L -1  blood lactate, V̇O 2max  or 15-min running distance performance trial during the intervention.
","[{'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': 'Inland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Ole Martin', 'Initials': 'OM', 'LastName': 'Lid', 'Affiliation': 'Inland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Inland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Hamarsland', 'Affiliation': 'Inland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Knut Sindre', 'Initials': 'KS', 'LastName': 'Mølmen', 'Affiliation': 'Inland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Nygaard', 'Affiliation': 'Inland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Ellefsen', 'Affiliation': 'Inland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hammarström', 'Affiliation': 'Inland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Lundby', 'Affiliation': 'Inland University of Applied Sciences, Lillehammer, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.14156']
622,35306247,The effect of using an interactive mobile application for the management of chemotherapy-induced nausea and vomiting in children: Randomized controlled study.,"PURPOSE


This study was conducted to develop an interactive mobile application called 5inD, and investigate the effect of 5inD on the management of chemotherapy-induced nausea and vomiting (CINV) in pediatric oncology patients.
METHODS


The prospective, parallel-group and randomized controlled study was conducted in a university hospital between October 2019 and January 2021 with 57 children aged 8-18 years who were treated with chemotherapy and their mothers. In this study, a mobile application called ""5inD"" was developed, which includes five distraction methods to reduce CINV. Data were collected about CINV through the Adapted Rhodes Index for Nausea & Vomiting child version (ARINVc), and parent version (ARINVp). CINV of the children was evaluated for seven days starting from the first day of chemotherapy.
RESULTS


In the study, Child ARINVc and Parent ARINVp mean scores of the intervention groups were lower than the control group during the seven days (p < 0.05). There was a statistically significant difference between the group's Adapted Rhodes Index of Nausea and Vomiting for Pediatrics by Child (ARINVc) and by Parent (ARINVp) mean scores in terms of the group, time, and group*time interaction. While a statistically significant difference was found between the intervention group's and control group's mean scores in terms of the group, time, and group*time for the acute CINV (p < 0.05), there was no statistically significant difference for delayed CINV between groups scores in terms of the time, and group*time interaction (p > 0.05).
CONCLUSION


This study supports the findings that the interactive mobile application was found effective in reducing CINV in children. Additionally, it can be said 5inD is more effective for the management of acute CINV than delayed CINV.",2022,"There was a statistically significant difference between the group's Adapted Rhodes Index of Nausea and Vomiting for Pediatrics by Child (ARINVc) and by Parent (ARINVp) mean scores in terms of the group, time, and group*time interaction.","['university hospital between October 2019 and January 2021 with 57 children aged 8-18 years who were treated with chemotherapy and their mothers', 'pediatric oncology patients', 'children']",['interactive mobile application'],"['Rhodes Index of Nausea and Vomiting for Pediatrics by Child (ARINVc) and by Parent (ARINVp) mean scores', 'delayed CINV', 'nausea and vomiting', 'nausea and vomiting (CINV']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454812', 'cui_str': 'Rhodes'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}]",57.0,0.0188272,"There was a statistically significant difference between the group's Adapted Rhodes Index of Nausea and Vomiting for Pediatrics by Child (ARINVc) and by Parent (ARINVp) mean scores in terms of the group, time, and group*time interaction.","[{'ForeName': 'Remziye', 'Initials': 'R', 'LastName': 'Semerci', 'Affiliation': 'Koç University, School of Nursing, Department of Pediatric Nursing, Topkapı, 34010, İstanbul, Turkey. Electronic address: RSEMERCI@ku.edu.tr.'}, {'ForeName': 'Melahat', 'Initials': 'M', 'LastName': 'Akgün Kostak', 'Affiliation': 'Trakya University Faculty of Health Sciences, Department of Pediatric Nursing, 22030, Edirne, Turkey. Electronic address: akgunkostak@yahoo.com.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Taşkın', 'Affiliation': 'Trakya University, Faculty of Engineering, Department of Computer Engineering, 22030, Edirne, Turkey. Electronic address: cemtaskin82@gmail.com.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2022.102121']
623,35314453,Echo-guided left ventricular assist device speed optimisation for exercise maximisation.,"OBJECTIVE


Current generation left ventricular assist devices (LVADs) operate with a fixed rotation speed and no automated speed adjustment function. This study evaluates the concept of physiological pump speed optimisation based on aortic valve opening (AVO) imaging during a cardiopulmonary exercise test (CPET).
METHODS


This prospective crossover study (NCT05063006) enrolled patients with implanted third-generation LVADs with hydrodynamic bearing. After resting speed optimisation, patients were randomised to a fixed-modified speed or modified-fixed speed CPET sequence. Fixed speed CPET maintained baseline pump settings. During the modified speed CPET, the LVAD speed was continuously altered to preserve periodic AVO.
RESULTS


We included 22 patients, the mean age was 58.4±7 years, 4.5% were women and 54.5% had ischaemic cardiomyopathy. Exertional AVO assessment was feasible in all subjects. Maintaining periodic AVO allowed to safely raise the pump speed from 2900 (IQR 2640-3000) to 3440 revolutions per minute (RPM) (IQR 3100-3700; p<0.001). As a result, peak oxygen consumption increased from 11.1±2.4 to 12.8±2.8 mL/kg/min (p<0.001) and maximum workload from 1.1 (IQR 0.9-1.5) to 1.2 W/kg (IQR 0.9-1.7; p=0.028). The Borg scale exertion level decreased from 15.2±1.5 to 13.5±1.2 (p=0.005).
CONCLUSIONS


Transthoracic AVO imaging is possible during CPETs in patients with LVAD. Dynamic echo-guided pump speed adjustment based on the AVO improves exercise tolerance and augments peak oxygen consumption and maximum workload.",2022,"The Borg scale exertion level decreased from 15.2±1.5 to 13.5±1.2 (p=0.005).
","['22 patients, the mean age was 58.4±7 years, 4.5% were women and 54.5% had ischaemic cardiomyopathy', 'enrolled patients with implanted third-generation LVADs with hydrodynamic bearing', 'patients with LVAD']","['aortic valve opening (AVO) imaging during a cardiopulmonary exercise test (CPET', 'fixed-modified speed or modified-fixed speed CPET sequence']","['peak oxygen consumption and maximum workload', 'peak oxygen consumption', 'maximum workload', 'scale exertion level', 'Exertional AVO assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2936194', 'cui_str': 'Fluid Dynamics'}]","[{'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",22.0,0.0445406,"The Borg scale exertion level decreased from 15.2±1.5 to 13.5±1.2 (p=0.005).
","[{'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Stapor', 'Affiliation': 'Department of Interventional Cardiology, John Paul II Hospital, Krakow, Malopolska, Poland m.stapor@szpitaljp2.krakow.pl.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pilat', 'Affiliation': 'Department of Automatic Control and Robotics, AGH University of Science and Technology, Krakow, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Gackowski', 'Affiliation': 'Department of Coronary Disease and Heart Failure, Jagiellonian University Medical College, Faculty of Medicine, Institute of Cardiology, Krakow, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Misiuda', 'Affiliation': 'Noninvasive Cardiovascular Laboratory, John Paul II Hospital, Krakow, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Gorkiewicz-Kot', 'Affiliation': 'Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital, Krakow, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kaleta', 'Affiliation': 'Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital, Krakow, Poland.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Kleczynski', 'Affiliation': 'Department of Interventional Cardiology, Jagiellonian University Medical College, Faculty of Medicine, Institute of Cardiology, Krakow, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zmudka', 'Affiliation': 'Department of Interventional Cardiology, Jagiellonian University Medical College, Faculty of Medicine, Institute of Cardiology, Krakow, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Legutko', 'Affiliation': 'Department of Interventional Cardiology, Jagiellonian University Medical College, Faculty of Medicine, Institute of Cardiology, Krakow, Poland.'}, {'ForeName': 'Boguslaw', 'Initials': 'B', 'LastName': 'Kapelak', 'Affiliation': 'Department of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, Faculty of Medicine, Institute of Cardiology, Krakow, Poland.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Wierzbicki', 'Affiliation': 'Department of Cardiovascular Surgery and Transplantology, Jagiellonian University Medical College, Faculty of Medicine, Institute of Cardiology, Krakow, Poland.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2021-320495']
624,35315950,Information From Same-Race/Ethnicity Experts Online Does Not Increase Vaccine Interest or Intention to Vaccinate.,"Policy Points Mass vaccination is essential for bringing the COVID-19 pandemic to a close, yet substantial disparities remain between whites and racial and ethnic minorities within the United States. Online messaging campaigns featuring expert endorsements are a low-cost way to increase vaccine awareness among minoritized populations, yet the efficacy of same-race/ethnicity expert messaging in increasing uptake remains unknown. Our preregistered analysis of an online vaccine endorsement campaign, which randomly varied the racial/ethnic identity of the expert, revealed no evidence that information from same race/ethnicity experts affected vaccine interest or the intention to vaccinate. Our results do not rule out the possibility that other low-cost endorsement campaigns may be more effective in increasing vaccine uptake, but do suggest that public health campaigns might profitably focus on issues of access and convenience when targeting minoritized populations in the United States.
CONTEXT


The COVID-19 pandemic in the United States has been unequally experienced across racial and ethnic groups. Mass vaccination is the most effective way to bring the pandemic to an end and to manage its public health consequences. But the racialization of public health delivery in the United States has produced a sizable racial/ethnic gap in vaccination rates. Closing this gap in vaccine uptake is therefore essential to ending the pandemic.
METHODS


We conducted a preregistered, well-powered (N = 2,117) between-subjects survey experiment, fielded March 24 to April 5, 2021, in which participants from YouGov's online panel-including oversamples of Black (n = 471), Hispanic/Latino/a (n = 430), and Asian American (n = 319) participants-were randomly assigned to see COVID-19 vaccine information endorsed by same- or different-race/ethnicity experts or to a control condition. We then measured respondents' vaccination intentions, intention to encourage others to get vaccinated, and interest in learning more information and sharing information with others.
FINDINGS


Same-race/ethnicity expert endorsements had no measurable effect on nonwhite or white respondents' willingness to get the COVID-19 vaccine, to encourage others to get the vaccine, or to learn more or share information with others.
CONCLUSIONS


Our study provides empirical evidence suggesting online endorsements from same-race/ethnicity experts do not increase vaccine interest, advocacy, or uptake, though same-race/ethnicity endorsements may be effective in other venues or mediums.",2022,"Online messaging campaigns featuring expert endorsements are a low-cost way to increase vaccine awareness among minoritized populations, yet the efficacy of same-race/ethnicity expert messaging in increasing uptake remains unknown.","[""preregistered, well-powered (N = 2,117) between-subjects survey experiment, fielded March 24 to April 5, 2021, in which participants from YouGov's online panel-including oversamples of Black (n = 471), Hispanic/Latino/a (n = 430), and Asian American (n = 319) participants""]",['COVID-19 vaccine information endorsed by same- or different-race/ethnicity experts or to a control condition'],[],"[{'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0003988', 'cui_str': 'Asian Americans'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],2117.0,0.102838,"Online messaging campaigns featuring expert endorsements are a low-cost way to increase vaccine awareness among minoritized populations, yet the efficacy of same-race/ethnicity expert messaging in increasing uptake remains unknown.","[{'ForeName': 'Shana Kushner', 'Initials': 'SK', 'LastName': 'Gadarian', 'Affiliation': 'Syracuse University.'}, {'ForeName': 'Sara Wallace', 'Initials': 'SW', 'LastName': 'Goodman', 'Affiliation': 'University of California, Irvine.'}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Michener', 'Affiliation': 'Cornell University.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Nyhan', 'Affiliation': 'Dartmouth College.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Pepinsky', 'Affiliation': 'Cornell University.'}]",The Milbank quarterly,['10.1111/1468-0009.12561']
625,35322793,SGLT2 Inhibition and Uric Acid Excretion in Patients with Type 2 Diabetes and Normal Kidney Function.,"BACKGROUND AND OBJECTIVES


Sodium-glucose transporter 2 (SGLT2) inhibitor-induced uric acid lowering may contribute to kidney-protective effects of the drug class in people with type 2 diabetes. This study investigates mechanisms of plasma uric acid lowering by SGLT2 inhibitors in people with type 2 diabetes with a focus on urate transporter 1.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We conducted an analysis of two randomized clinical trials. First, in the Renoprotective Effects of Dapagliflozin in Type 2 Diabetes study, 44 people with type 2 diabetes were randomized to dapagliflozin or gliclazide for 12 weeks. Plasma uric acid, fractional uric acid excretion, and hemodynamic kidney function were measured in the fasted state and during clamped euglycemia or hyperglycemia. Second, in the Uric Acid Excretion study, ten people with type 2 diabetes received 1 week of empagliflozin, urate transporter 1 blocker benzbromarone, or their combination in a crossover design, and effects on plasma uric acid, fractional uric acid excretion, and 24-hour uric acid excretion were measured.
RESULTS


In the Renoprotective Effects of Dapagliflozin in Type 2 Diabetes study, compared with the fasted state (5.3±1.1 mg/dl), acute hyperinsulinemia and hyperglycemia significantly reduced plasma uric acid by 0.2±0.3 and 0.4±0.3 mg/dl (both  P <0.001) while increasing fractional uric acid excretion (by 3.2%±3.1% and 8.9%±4.5%, respectively; both  P <0.001). Dapagliflozin reduced plasma uric acid by 0.8±0.8 during fasting, 1.0±1.0 in hyperinsulinemic-euglycemic state, and 0.8±0.7 mg/dl during hyperglycemic conditions ( P <0.001), respectively, whereas fractional uric acid excretion in 24-hour urine increased by 3.0%±2.1% ( P <0.001) and 2.6%±4.5% during hyperinsulinemic-euglycemic conditions ( P =0.003). Fractional uric acid excretion strongly correlated to fractional glucose excretion ( r =0.35;  P =0.02). In the Uric Acid Excretion study, empagliflozin and benzbromarone both significantly reduced plasma uric acid and increased fractional uric acid excretion. Effects of combination therapy did not differ from benzbromarone monotherapy.
CONCLUSIONS


In conclusion, SGLT2 inhibitors induce uric acid excretion, which is strongly linked to urinary glucose excretion and is attenuated during concomitant pharmacologic blockade of urate transporter 1.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Renoprotective Effects of Dapagliflozin in Type 2 Diabetes (RED), NCT02682563; SGLT2 Inhibition: Uric Acid Excretion Study (UREX), NCT05210517.",2022,"Fractional uric acid excretion strongly correlated to fractional glucose excretion (r= 0.35, p=0.02).","['Type 2 Diabetes (RED) study, 44 people with type 2 diabetes', '10 people with type 2 diabetes', 'people with type 2 diabetes with a focus on urate transporter (URAT)1', 'people with type 2 diabetes', 'Patients with Type 2 Diabetes and Normal Kidney Function']","['plasma uric acid lowering by SGLT2-inhibitors', 'dapagliflozin or gliclazide', 'empagliflozin, benzbromarone', 'Dapagliflozin', 'combination therapy', 'empagliflozin and benzbromarone']","['Fractional uric acid excretion', 'plasma uric acid and increased fractional uric acid excretion', 'plasma uric acid, fractional uric acid excretion and 24-hr uric acid excretion', 'Plasma uric acid, fractional uric acid excretion and hemodynamic kidney function', 'fractional uric acid excretion', 'acute hyperinsulinemia and hyperglycemia significantly reduced plasma uric acid', 'fractional glucose excretion', 'fasting, hyperinsulinemic-euglycemic and hyperglycemic conditions', 'fractional uric acid excretion in 24-hr urine', 'SGLT2 Inhibition and Uric Acid Excretion', 'plasma uric acid']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0534759', 'cui_str': 'urate transporter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]","[{'cui': 'C0857451', 'cui_str': 'Plasma uric acid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0005035', 'cui_str': 'Benzbromarone'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0857451', 'cui_str': 'Plasma uric acid'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",44.0,0.172474,"Fractional uric acid excretion strongly correlated to fractional glucose excretion (r= 0.35, p=0.02).","[{'ForeName': 'Danii L S', 'Initials': 'DLS', 'LastName': 'Suijk', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands d.suijk@amsterdamumc.nl.'}, {'ForeName': 'Michaël J B', 'Initials': 'MJB', 'LastName': 'van Baar', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik J M', 'Initials': 'EJM', 'LastName': 'van Bommel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Iqbal', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Merle M', 'Initials': 'MM', 'LastName': 'Krebber', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Vallon', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology and Transplantation, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark M H', 'Initials': 'MMH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.11480821']
626,35325257,A single oral dose of citalopram increases interoceptive insight in healthy volunteers.,"RATIONALE


Interoception is the signalling, perception, and interpretation of internal physiological states. Many mental disorders associated with changes of interoception, including depressive and anxiety disorders, are treated with selective serotonin reuptake inhibitors (SSRIs). However, the causative link between SSRIs and interoception is not yet clear.
OBJECTIVES


To ascertain the causal effect of acute changes of serotonin levels on cardiac interoception.
METHODS


Using a within-participant placebo-controlled design, forty-seven healthy human volunteers (31 female, 16 male) were tested on and off a 20 mg oral dose of the commonly prescribed SSRI, citalopram. Participants made judgements on the synchrony between their heartbeat and auditory tones and then expressed confidence in each judgement. We measured three types of interoceptive cognition.
RESULTS


Citalopram increased cardiac interoceptive insight, measured as correspondence of self-reported confidence to the likelihood that interoceptive judgements were actually correct. This effect was driven by enhanced confidence for correct interoceptive judgements and was independent of measured cardiac and reported subjective effects of the drug.
CONCLUSIONS


An acute change of serotonin levels can increase insight into the reliability of inferences made from cardiac interoceptive sensations.",2022,"This effect was driven by enhanced confidence for correct interoceptive judgements and was independent of measured cardiac and reported subjective effects of the drug.
","['forty-seven healthy human volunteers (31 female, 16 male', 'healthy volunteers']","['SSRI, citalopram', 'citalopram']","['cardiac interoceptive insight', 'interoceptive insight']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0233820', 'cui_str': 'Insight'}]",47.0,0.056462,"This effect was driven by enhanced confidence for correct interoceptive judgements and was independent of measured cardiac and reported subjective effects of the drug.
","[{'ForeName': 'James J A', 'Initials': 'JJA', 'LastName': 'Livermore', 'Affiliation': 'School of Psychology, University of Sussex, Pevensey Building, Falmer, Brighton, BN1 9QH, UK.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Holmes', 'Affiliation': 'School of Psychology, University of Sussex, Pevensey Building, Falmer, Brighton, BN1 9QH, UK.'}, {'ForeName': 'Gyorgy', 'Initials': 'G', 'LastName': 'Moga', 'Affiliation': 'School of Psychology, University of Sussex, Pevensey Building, Falmer, Brighton, BN1 9QH, UK.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Adamatzky', 'Affiliation': 'School of Psychology, University of Sussex, Pevensey Building, Falmer, Brighton, BN1 9QH, UK.'}, {'ForeName': 'Hugo D', 'Initials': 'HD', 'LastName': 'Critchley', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School (BSMS), Brighton, UK.'}, {'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Garfinkel', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School (BSMS), Brighton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campbell-Meiklejohn', 'Affiliation': 'School of Psychology, University of Sussex, Pevensey Building, Falmer, Brighton, BN1 9QH, UK. daniel.cm@sussex.ac.uk.'}]",Psychopharmacology,['10.1007/s00213-022-06115-7']
627,35333547,Development of Team Behavior Skills and Clinical Lactation Competence Among Medical Students Engaging in Telesimulations with Standardized Patients.,"Objective:  The aims of this pilot feasibility study were to determine if telesimulations with standardized patients (SPs) wearing high-fidelity breast models impact students' team behavior and clinical competence in lactation support.  Materials and Methods:  Medical students ( N  = 19) completed five telesimulations: Cases 1, 2, 5 in a team, 3 as individual, and 4 randomized. SPs used the Formative Assessment Rubric (FAR) to evaluate interpersonal and clinical competence. Collaboration skills within team-based telesimulations (Cases 2 and 4) were rated using the Interprofessional Collaborator Assessment Rubric (ICAR). Satisfaction data were collected from a focus group and written evaluation. Descriptive statistics were calculated for FAR, ICAR, and written evaluations. Appropriate nonparametric tests were used to measure FAR and ICAR differences over time or between team and individual telesimulations and the relationship between FAR and ICAR scores. Content analysis was used to generate themes from focus group data.  Results:  Learners' interpersonal and lactation-specific competence improved over time ( p  = 0.003 and 0.009, respectively). Learners were able ""to accept responsibility for their actions"" more but spent less time ""seeking perspectives from peers"" in Case 4 compared with Case 2 ( p  = 0.01 and  p  < 0.001, respectively). Themes from the focus group related to the value of team telesimulations to learn clinical lactation skills and learn about one's role in a team. Learners agreed they developed clinical lactation skills (>4.5/5-pt).  Conclusions:  Opportunities to work collaboratively in telesimulations with a SP prepare learners for professional collaborations to effectively care for breast/chestfeeding dyads.",2022,"Results:  Learners' interpersonal and lactation-specific competence improved over time ( p  = 0.003 and 0.009, respectively).","['Medical students ( N \u2009=\u200919) completed five telesimulations: Cases 1, 2, 5 in a team, 3 as individual, and 4 randomized', 'Medical Students Engaging in Telesimulations with Standardized Patients']",['standardized patients (SPs) wearing high-fidelity breast models'],"['clinical lactation skills', 'Interprofessional Collaborator Assessment Rubric (ICAR', 'Team Behavior Skills and Clinical Lactation Competence', ""Learners' interpersonal and lactation-specific competence""]","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0876742', 'cui_str': 'Icar'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0277746,"Results:  Learners' interpersonal and lactation-specific competence improved over time ( p  = 0.003 and 0.009, respectively).","[{'ForeName': 'Olivia S', 'Initials': 'OS', 'LastName': 'Anderson', 'Affiliation': 'Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Department of Family Medicine, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Weirauch', 'Affiliation': 'Department of Family Medicine, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Chuisano', 'Affiliation': 'LiquidGoldConcept, Inc., Ypsilanti, Michigan, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sadovnikova', 'Affiliation': 'LiquidGoldConcept, Inc., Ypsilanti, Michigan, USA.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2021.0229']
628,35340062,Effect of Denosumab Compared With Risedronate on Bone Strength in Patients Initiating or Continuing Glucocorticoid Treatment.,"In a randomized clinical trial in patients initiating glucocorticoid therapy (GC-I) or on long-term therapy (GC-C), denosumab every 6 months increased spine and hip bone mineral density at 12 and 24 months significantly more than daily risedronate. The aim of this study was to evaluate the effects of denosumab compared with risedronate on bone strength and microarchitecture measured by high-resolution peripheral quantitative computed tomography (HR-pQCT) in GC-I and GC-C. A subset of 110 patients had high-resolution peripheral quantitative computed tomography (HR-pQCT) scans of the distal radius and tibia at baseline and at 12 and 24 months. Cortical and trabecular microarchitecture were assessed with standard analyses and failure load (FL) with micro-finite element analysis. At the radius at 24 months, FL remained unchanged with denosumab and significantly decreased with risedronate in GC-I (-4.1%, 95% confidence interval [CI] -6.4, -1.8) and, in GC-C, it significantly increased with denosumab (4.3%, 95% CI 2.1, 6.4) and remained unchanged with risedronate. Consequently, FL was significantly higher with denosumab than with risedronate in GC-I (5.6%, 95% CI 2.4, 8.7, p < 0.001) and in GC-C (4.1%, 95% CI 1.1, 7.2, p = 0.011). We also found significant differences between denosumab and risedronate in percentage changes in cortical and trabecular microarchitectural parameters in GC-I and GC-C. Similar results were found at the tibia. To conclude, this HR-pQCT study shows that denosumab is superior to risedronate in terms of preventing FL loss at the distal radius and tibia in GC-I and in increasing FL at the radius in GC-C, based on significant differences in changes in the cortical and trabecular bone compartments between treatment groups in GC-I and GC-C. These results suggest that denosumab could be a useful therapeutic option in patients initiating GC therapy or on long-term GC therapy and may contribute to treatment decisions in this patient population. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).",2022,We also found significant differences between denosumab and risedronate in percentage changes in cortical and trabecular microarchitectural parameters in GC-I and GC-C. Similar results were found at the tibia.,"['patients initiating', 'patients initiating or continuing glucocorticoid treatment', '110 patients had HR-pQCT scans of the distal radius and tibia at baseline, 12, and 24 months']","['denosumab and risedronate', 'risedronate', 'denosumab', 'glucocorticoid therapy (GC-I) or on long-term therapy (GC-C), denosumab', '95%-CI']","['bone strength', 'FL', 'spine and hip bone mineral density', 'bone strength and microarchitecture', 'FL loss', 'cortical and trabecular microarchitectural parameters', 'Cortical and trabecular microarchitecture', 'cortical and trabecular bone compartments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}]",,0.0345812,We also found significant differences between denosumab and risedronate in percentage changes in cortical and trabecular microarchitectural parameters in GC-I and GC-C. Similar results were found at the tibia.,"[{'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Geusens', 'Affiliation': 'Department of Internal Medicine, Subdivision of Rheumatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Melissa Sam', 'Initials': 'MS', 'LastName': 'Bevers', 'Affiliation': 'Department of Internal Medicine, VieCuri Medical Center, Venlo, The Netherlands.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'van Rietbergen', 'Affiliation': 'Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Osvaldo D', 'Initials': 'OD', 'LastName': 'Messina', 'Affiliation': 'IRO Medical Center, Investigaciones Reumatologicas y Osteologicas SRL, Buenos Aires, Argentina.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': 'Regional Hospital of Orleans, Translational Medicine Research Platform, PRIMMO, Orleans, France.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Oliveri', 'Affiliation': 'INIGEM, Hospital de Clínicas José de San Martin, Buenos Aires, Argentina.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Chapurlat', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Hospital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Engelke', 'Affiliation': 'Bioclinica Inc, Hamburg, Germany.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Joop P', 'Initials': 'JP', 'LastName': 'van den Bergh', 'Affiliation': 'Department of Internal Medicine, Subdivision of Rheumatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4551']
629,35347756,A generalized weighted combination test of treatment effect for clinical trials with a sequential parallel comparison design and binary endpoint.,"To address the issue of a large placebo effect in certain therapeutic areas, rather than the application of the traditional gold standard parallel group placebo-controlled design, different versions of the sequential parallel comparison design have been advocated. In general, the design consists of two consecutive stages and three treatment groups. Stage 1 placebo nonresponders potentially form a prespecified patient subgroup for formal between-treatment comparison at the final analysis. In this research, a version of the design is considered for a binary endpoint. To fully utilize all available data, a generalized weighted combination test is proposed in case placebo has a relatively small effect for some of the study endpoints. The weighted combination of the test based on stage 1 data and the test based on stage 2 data of stage 1 placebo nonresponders suggested in the literature uses only a part of the study data and is a special case of this generalized weighted combination test. A multiple imputation approach is outlined for handling missing not at random data. Simulation is conducted to evaluate the performances of the methods and a data example is employed to illustrate the applications of the methods.",2022,Simulation is conducted to evaluate the performances of the methods and a data example is employed to illustrate the applications of the methods.,[],[],[],[],[],[],,0.334997,Simulation is conducted to evaluate the performances of the methods and a data example is employed to illustrate the applications of the methods.,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Quan', 'Affiliation': 'Biostatistics and Programming, Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Programming, Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Junxiang', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Biostatistics and Programming, Moderna, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Programming, Sanofi, Bridgewater, New Jersey, USA.'}]",Statistics in medicine,['10.1002/sim.9381']
630,35351144,Physical activity enhances the improvement of body mass index and metabolism by inulin: a multicenter randomized placebo-controlled trial performed in obese individuals.,"BACKGROUND


Dietary interventions targeting the gut microbiota have been proposed as innovative strategies to improve obesity-associated metabolic disorders. Increasing physical activity (PA) is considered as a key behavioral change for improving health. We have tested the hypothesis that changing the PA status during a nutritional intervention based on prebiotic supplementation can alter or even change the metabolic response to the prebiotic. We confirm in obese subjects and in high-fat diet fed mice that performing PA in parallel to a prebiotic supplementation is necessary to observe metabolic improvements upon inulin.
METHODS


A randomized, single-blinded, multicentric, placebo-controlled trial was conducted in obese participants who received 16 g/day native inulin versus maltodextrin, coupled to dietary advice to consume inulin-rich versus -poor vegetables for 3 months, respectively, in addition to dietary caloric restriction. Primary outcomes concern the changes on the gut microbiota composition, and secondary outcomes are related to the measures of anthropometric and metabolic parameters, as well as the evaluation of PA. Among the 106 patients who completed the study, 61 patients filled a questionnaire for PA before and after intervention (placebo: n = 31, prebiotic: n = 30). Except the dietitian (who provided dietary advices and recipes book), all participants and research staff were blinded to the treatments and no advices related to PA were given to participants in order to change their habits. In parallel, a preclinical study was designed combining both inulin supplementation and voluntary exercise in a model of diet-induced obesity in mice.
RESULTS


Obese subjects who increased PA during a 3 months intervention with inulin-enriched diet exhibited several clinical improvements such as reduced BMI (- 1.6 kg/m 2 ), decreased liver enzymes and plasma cholesterol, and improved glucose tolerance. Interestingly, the regulations of Bifidobacterium, Dialister, and Catenibacterium genera by inulin were only significant when participants exercised more. In obese mice, we highlighted a greater gut fermentation of inulin and improved glucose homeostasis when PA is combined with prebiotics.
CONCLUSION


We conclude that PA level is an important determinant of the success of a dietary intervention targeting the gut microbiota.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03852069 (February 22, 2019 retrospectively registered).",2022,"Except the dietitian (who provided dietary advices and recipes book), all participants and research staff were blinded to the treatments and no advices related to PA were given to participants in order to change their habits.","['106 patients who completed the study, 61 patients filled a questionnaire for PA before and after intervention (placebo: n\u2009=\u200931, prebiotic: n\u2009=\u200930', 'obese individuals', 'obese subjects', 'obese participants who received', 'Obese subjects who increased PA']","['16\u2009g/day native inulin versus maltodextrin, coupled to dietary advice to consume inulin-rich versus -poor vegetables', 'placebo', 'inulin supplementation and voluntary exercise']","['regulations of Bifidobacterium, Dialister, and Catenibacterium genera by inulin', 'reduced BMI', 'glucose homeostasis', 'liver enzymes and plasma cholesterol, and improved glucose tolerance', 'gut microbiota composition, and secondary outcomes are related to the measures of anthropometric and metabolic parameters, as well as the evaluation of PA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}]","[{'cui': 'C0456636', 'cui_str': '16G'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1008539', 'cui_str': 'Dialister'}, {'cui': 'C1065645', 'cui_str': 'Catenibacterium'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",61.0,0.148989,"Except the dietitian (who provided dietary advices and recipes book), all participants and research staff were blinded to the treatments and no advices related to PA were given to participants in order to change their habits.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Rodriguez', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Audrey M', 'Initials': 'AM', 'LastName': 'Neyrinck', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Van Kerckhoven', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Gianfrancesco', 'Affiliation': 'Laboratory of Diabetology, Nutrition and Metabolic Disease, Université de Liège, Liège, Belgium.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Renguet', 'Affiliation': 'Pole of Cardiovascular Research, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bertrand', 'Affiliation': 'Pole of Cardiovascular Research, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Patrice D', 'Initials': 'PD', 'LastName': 'Cani', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lanthier', 'Affiliation': 'Laboratory of Hepatogastroenterology, Institut de Recherche Expérimentale et Clinique, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Cnop', 'Affiliation': 'ULB Center for Diabetes Research, Université Libre de Bruxelles, and Division of Endocrinology, Erasmus Hospital, Brussels, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Paquot', 'Affiliation': 'Laboratory of Diabetology, Nutrition and Metabolic Disease, Université de Liège, Liège, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Thissen', 'Affiliation': 'Pole of Endocrinology, Diabetes and Nutrition, Institut de Recherche Expérimentale et Clinique, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Laure B', 'Initials': 'LB', 'LastName': 'Bindels', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium. Nathalie.delzenne@uclouvain.be.'}]",BMC medicine,['10.1186/s12916-022-02299-z']
631,35302681,Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction.,"BACKGROUND AND PURPOSE


Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin-gene-related peptide, has demonstrated efficacy as a preventive treatment for adults with episodic migraine or chronic migraine and inadequate response to two to four prior preventive treatment classes in the phase 3b FOCUS study. In this post hoc analysis, efficacy and effects on quality-of-life outcomes for fremanezumab were evaluated in subgroups of patients with and without aura or similar neurological symptoms, here referred to as migraine with or without associated neurological dysfunction.
METHODS


In the FOCUS study, 838 patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab or matched placebo for 12 weeks of double-blind treatment. For this post hoc analysis, subgroups of patients with migraine with and without associated neurological dysfunction at baseline were identified based on patient response to questions about symptoms.
RESULTS


In patients with migraine with associated neurological dysfunction at baseline, fremanezumab significantly reduced monthly average days with neurological symptoms (quarterly, -1.7 days; monthly, -1.8 days) compared to placebo (-0.5 days; both p ≤ 0.01). In comparison with placebo, both dosing regimens of fremanezumab yielded greater reductions in monthly migraine days over 12 weeks (p < 0.0001) and improvements in Headache Impact Test 6 and Migraine-Specific Quality of Life scores over the last 4 weeks (p < 0.05), regardless of neurological dysfunction at baseline.
CONCLUSIONS


Fremanezumab reduced days with neurological symptoms, effectively prevented migraine, and improved quality of life in patients with migraine with associated neurological dysfunction, including those with previous inadequate response to two to four migraine preventive medication classes.",2022,"In comparison with placebo, both dosing regimens of fremanezumab yielded greater reductions in monthly migraine days over 12 weeks (P <0.0001) and improvements in Headache Impact Test-6 and Migraine-specific Quality of Life scores over the last 4 weeks (P <0.05), regardless of neurological dysfunction at baseline.
","['838 patients', 'subgroups of patients with and without aura or similar neurological symptoms, here referred to as migraine with or without associated neurological dysfunction', 'patients with difficult-to-treat migraine with associated neurological dysfunction', 'patients with migraine with associated neurological dysfunction', 'adults with episodic migraine (EM) or chronic migraine (CM) and inadequate response to 2-4 prior preventive treatment classes in the phase 3b FOCUS study']","['Fremanezumab', 'placebo', 'quarterly fremanezumab, monthly fremanezumab, or matched placebo', 'fremanezumab']","['neurological dysfunction', 'neurological symptoms', 'quality-of-life outcomes', 'Efficacy and quality-of-life improvements', 'quality of life', 'Headache Impact Test-6 and Migraine-specific Quality of Life scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",838.0,0.14401,"In comparison with placebo, both dosing regimens of fremanezumab yielded greater reductions in monthly migraine days over 12 weeks (P <0.0001) and improvements in Headache Impact Test-6 and Migraine-specific Quality of Life scores over the last 4 weeks (P <0.05), regardless of neurological dysfunction at baseline.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lampl', 'Affiliation': 'Department of Neurology and Headache Medical Centre, Konventhospital Barmherzige Brüder Linz, Linz, Austria.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Rapoport', 'Affiliation': 'Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Barash', 'Affiliation': 'Statistics, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ramirez Campos', 'Affiliation': 'Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seminerio', 'Affiliation': 'North American Medical Affairs, Teva Pharmaceuticals USA, Inc., Parsippany, New Jersey, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Ning', 'Affiliation': 'Global Clinical Development, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}]",European journal of neurology,['10.1111/ene.15328']
632,35304842,An Online Weight Loss Intervention for People With Obesity and Poorly Controlled Asthma.,"BACKGROUND


Weight loss might improve asthma control in people with obesity. However, people with asthma might have particular challenges losing weight and the amount of weight loss needed to improve asthma control is not clear.
OBJECTIVES


To pilot-test an online weight loss intervention and to estimate the impact of weight loss on asthma control.
METHODS


We performed a 6-month, single-arm, futility trial of an online weight loss intervention at 2 centers. To reject the assumption of futility, 9 or more participants had to lose at least 5% of their body weight. We also assessed the association between weight loss (≥5%) and asthma outcomes.
RESULTS


Forty-three participants (85% women) started the weight loss intervention. The median and interquartile range for the body mass index was 40.3 kg/m 2  (range 34.7-46.8 kg/m 2 ), and 14 (range 12-17 kg/m 2 ) for the Asthma Control Test score. At 6 months, 10 participants (23%; 95% CI 12%-39%) lost at least 5% of their initial weight. Weight loss of at least 5% was associated with a clinically and statistically significant improvements in their Asthma Control Test (median [interquartile range] increase of 3 [1 to 7]; P < .05), Marks Asthma Quality of Life Score (-9.5 [-18 to -3]; P = .008), and their general health-related quality of life score (RAND-36; improved by 9.4 [2.8 to 22.5]; P =.014).
CONCLUSIONS


An online weight loss intervention has the potential to meet U.S. Food and Drug Administration guidance for product evaluation (at least a 5% weight loss in 35% of people) for treating obesity, and is associated with a clinically significant improvement in asthma control, quality of life, and overall health-related quality of life.",2022,"Weight loss of at least 5% was associated with a clinically and statistically significant improvements in their Asthma Control Test (median [IQR] increase of 3 [1 7], p< 0.05), Marks Asthma Quality of Life Score","['people with obesity', 'people with obesity and poorly controlled asthma']",['online weight loss intervention'],"['weight loss', 'Marks Asthma Quality of Life Score', 'Weight loss', 'weight loss intervention; median and interquartile range (IQR) for BMI', 'asthma control, quality of life, and overall health-related quality of life', 'general health-related quality of life score (RAND-36']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",85.0,0.0594285,"Weight loss of at least 5% was associated with a clinically and statistically significant improvements in their Asthma Control Test (median [IQR] increase of 3 [1 7], p< 0.05), Marks Asthma Quality of Life Score","[{'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Larner College of Medicine, University of Vermont, Burlington, Vt.'}, {'ForeName': 'Lynn B', 'Initials': 'LB', 'LastName': 'Gerald', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, Tucson, Ariz; Asthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Harvey', 'Affiliation': 'Department of Nutrition and Food Science, College of Agriculture and Life Sciences, University of Vermont, Burlington, Vt.'}, {'ForeName': 'Gem', 'Initials': 'G', 'LastName': 'Roy', 'Affiliation': 'Department of Epidemiology, Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hazucha', 'Affiliation': 'Department of Epidemiology, Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.'}, {'ForeName': 'Chelsey', 'Initials': 'C', 'LastName': 'Large', 'Affiliation': 'Asthma and Airway Disease Research Center, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Burke', 'Affiliation': 'Department of Epidemiology, Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'McCormack', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Department of Epidemiology, Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Dixon', 'Affiliation': 'Department of Medicine, Larner College of Medicine, University of Vermont, Burlington, Vt. Electronic address: anne.dixon@uvmhealth.org.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2022.02.040']
633,35312441,"Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial.","OBJECTIVES


The immunogenicity of hepatitis B vaccine is unsatisfactory in the people living with HIV (PLHIV). Studies evaluating optimal regimens to enhance immunogenicity have heretofore been inconclusive. The study was to compare the immunogenicity and safety of the four standard-dose and high-dose regimens of hepatitis B vaccine among PLHIV.
METHODS


A randomized, parallel-controlled trial was conducted between May, 2020, and January, 2021. Patients were randomly assigned to receive 3 or 4 doses of 20 or 60 µg of hepatitis B vaccine. Seroconversion rate, high-level response rate, and geometric mean concentration (GMC) of antibody to hepatitis B surface antigen (anti-HBs) at weeks 12 and 28 were the main outcome measures.
RESULTS


At week 28, the seroconversion rate and GMC of anti-HBs in both IM20 × 4 and IM60 × 4 groups were significantly higher than those in the IM20 × 3 group ( P  < 0.05), and the GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group.
CONCLUSIONS


In PLHIV, both the four standard-dose and high-dose regimens significantly improved immunogenicity. The GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov (NCT03962803).",2022,"The GMC of anti-HBs was numerically higher in the IM60×4 group than that in the IM20×4 group.
","['May, 2020, and January, 2021 in China', 'people living with HIV', 'people living with HIV (PLHIV']","['4 intramuscular standard-dose and high-dose hepatitis B vaccinee', 'hepatitis B vaccine']","['seroconversion rate and GMC of anti-HBs', 'Immunogenicity and safety', 'GMC of anti-HBs', 'immunogenicity', 'immunogenicity and safety', 'Seroconversion rate, high-level response rate, and geometric mean concentration (GMC) of antibody to hepatitis B surface antigen (anti-HBs']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0369334', 'cui_str': 'Antibody to hepatitis B surface antigen'}]",,0.176113,"The GMC of anti-HBs was numerically higher in the IM60×4 group than that in the IM20×4 group.
","[{'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'School of Public Health, Shanxi Medical University, Taiyuan, Shanxi PR, China.'}, {'ForeName': 'Zhuanzhuan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Shanxi Medical University, Taiyuan, Shanxi PR, China.'}, {'ForeName': 'Ruixue', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'School of Public Health, Shanxi Medical University, Taiyuan, Shanxi PR, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Yao', 'Affiliation': 'School of Public Health, Shanxi Medical University, Taiyuan, Shanxi PR, China.'}, {'ForeName': 'Yuanting', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Public Health, Shanxi Medical University, Taiyuan, Shanxi PR, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, The Second Hospital of Yuncheng, Yuncheng, Shanxi PR, China.'}, {'ForeName': 'Chenli', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of STD and AIDS Control and Prevention, Shanxi Provincial Center for Disease Control and Prevention, Shanxi, PR, China.'}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Nie', 'Affiliation': 'Department of STD and AIDS Control and Prevention, Shanxi Provincial Center for Disease Control and Prevention, Shanxi, PR, China.'}, {'ForeName': 'Fuzhen', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of National Immunization Program, Chinese Center for Disease Control and Prevention, Beijing, PR China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Chinese Preventive Medicine Association, Beijing, PR China.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Shanxi Medical University, Taiyuan, Shanxi PR, China.'}]",Expert review of vaccines,['10.1080/14760584.2022.2056024']
634,35312652,A Pilot Study of a Patient Navigation Intervention to Improve HIV Pre-exposure Prophylaxis Persistence Among Black/African American Men Who Have Sex With Men.,"BACKGROUND


Suboptimal HIV pre-exposure prophylaxis (PrEP) care outcomes among Black/African American men who have sex with men (MSM) limits its population-level effects on HIV incidence. We conducted a pilot study of a brief patient navigation intervention aimed at improving PrEP initiation and persistence among Black/African American MSM in the Southern United States.
SETTING


Community health center in Jackson, MS.
METHODS


We recruited 60 Black/African American MSM aged 18-34 years who were newly prescribed PrEP. Participants were randomized to receive the clinic's current standard of care or an intervention condition including a single patient navigation session to discuss and address perceived barriers to initiating and maintaining access to PrEP and biweekly check-ins. Participants were followed over 6 months using survey assessments, medical chart review, and pharmacy purchase records to ascertain PrEP initiation and persistence.
RESULTS


Participants in the intervention condition were more likely to pick up their initial PrEP prescription [RR: 1.47; 95% confidence interval (CI): 1.10 to 1.97], be retained in PrEP care at 3 months (RR: 1.62; 95% CI: 1.01 to 2.59) and 6 months (RR: 1.38; 95% CI: 0.64 to 2.93), and have access to PrEP medications greater than 80% of all study days based on pharmacy fill records (RR: 3.00; 95% CI: 1.50 to 5.98).
CONCLUSION


A brief patient navigation intervention demonstrated proof-of-concept in improving PrEP initiation and persistence among Black/African American MSM in the Southern United States.",2022,A brief patient navigation intervention demonstrated proof-of-concept in improving PrEP initiation and persistence among Black/African American MSM in the Southern United States.,"['60 Black/African American MSM aged 18 to 34 years old who were newly prescribed PrEP', 'Who Have Sex with Men', 'Black/African American MSM in the Southern United States', 'Black/African American Men', 'Black/African American men who have sex with men (MSM', 'Community health center in Jackson, Mississippi']","['Suboptimal HIV pre-exposure prophylaxis (PrEP', ""clinic's current standard of care, or an intervention condition including a single patient navigation session to discuss and address perceived barriers to initiating and maintaining access to PrEP and biweekly check-ins"", 'patient navigation intervention', 'Patient Navigation Intervention']","['HIV Pre-Exposure Prophylaxis Persistence', 'likely to pick up their initial PrEP prescription']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}]","[{'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}]","[{'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",60.0,0.115234,A brief patient navigation intervention demonstrated proof-of-concept in improving PrEP initiation and persistence among Black/African American MSM in the Southern United States.,"[{'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goedel', 'Affiliation': 'Department of Epidemiology, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Cassandra Sutten', 'Initials': 'CS', 'LastName': 'Coats', 'Affiliation': 'Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Warren Alpert Medical School, Brown University, Providence, RI.'}, {'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'Sims-Gomillia', 'Affiliation': 'Department of Population Health Science, University of Mississippi Medical Center, Jackson, MS; and.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Brock', 'Affiliation': 'Department of Medicine, School of Medicine, University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Ward', 'Affiliation': 'Department of Population Health Science, University of Mississippi Medical Center, Jackson, MS; and.'}, {'ForeName': 'Leandro A', 'Initials': 'LA', 'LastName': 'Mena', 'Affiliation': 'Department of Population Health Science, University of Mississippi Medical Center, Jackson, MS; and.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Nunn', 'Affiliation': 'Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002954']
635,35314114,Reply to comment on: Androgen deprivation therapy and radiotherapy in intermediate-risk prostate cancer: A randomised phase III trial.,,2022,,['intermediate-risk prostate cancer'],['Androgen deprivation therapy and radiotherapy'],[],"[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.132726,,"[{'ForeName': 'Abdenour', 'Initials': 'A', 'LastName': 'Nabid', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Quebec, Canada. Electronic address: abdenour.nabid@usherbrooke.ca.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': 'McGill University Faculty of Medicine and Health Sciences, Canada.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.01.042']
636,35315076,Effect Evaluation of a School-Based Intervention Promoting Sleep in Adolescents: A Cluster-Randomized Controlled Trial.,"BACKGROUND


This study evaluated the effect of the school-based intervention Charge Your Brainzzz on adolescents' social-cognitive determinants, sleep hygiene and sleep duration and quality.
METHODS


A cluster-randomized controlled trial was conducted with 972 students from 10 Dutch high schools. Schools were randomly allocated to the intervention (N = 5) or control condition (N = 5). Outcomes were measured with the digital Consensus Sleep Diary and via a digital questionnaire, based on valid measures. Data were collected at baseline (T0), ±1.5 weeks post-intervention (T1) and ±3 months post-intervention (T2). Mixed model analyses were performed to estimate the effects on social-cognitive determinants, sleep hygiene, and sleep outcomes.
RESULTS


The intervention increased sleep knowledge post-intervention (b = 1.91; 95%CI: 1.22-2.60) and at follow up (b = 1.40; 95%CI: 0.70-2.10). The intervention was also effective in changing adolescents' attitudes (b = 0.10; 95%CI: 0.01-0.19) and perceived behavioral control (b = 0.11; 95%CI: 0.01-0.22) post-intervention. No positive changes were found regarding subjective norms, behavioral intentions, sleep hygiene, or sleep outcomes.
CONCLUSIONS


The intervention improved adolescents' sleep knowledge, attitude, and perceived behavioral control. To significantly impact sleep health, theoretically sound and systematically developed interventions are needed which take into account the interplay between sleep, sleep-related behaviors, and adolescents' social and physical environment.
CLINICAL TRIAL REGISTRATION


Trial name: Evaluation of the school-based intervention Charge Your Brainzzz promoting sleep in adolescents; URL: https://doi.org/10.1186/ISRCTN36701918; ID: ISRCTN36701918.",2022,The intervention increased sleep knowledge post-intervention (b = 1.91; 95%CI: 1.22-2.60) and at follow up (b = 1.40; 95%CI: 0.70-2.10).,"['Adolescents', '972 students from 10 Dutch high schools']","['School-Based Intervention Promoting Sleep', 'school-based intervention Charge Your Brainzzz', 'intervention (N\xa0=\xa05) or control condition', 'school-based intervention']","['social-cognitive determinants, sleep hygiene, and sleep outcomes', ""adolescents' sleep knowledge, attitude, and perceived behavioral control"", 'digital Consensus Sleep Diary and via a digital questionnaire, based on valid measures', 'subjective norms, behavioral intentions, sleep hygiene, or sleep outcomes', ""adolescents' social-cognitive determinants, sleep hygiene and sleep duration and quality"", 'sleep knowledge post-intervention', 'behavioral control']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",972.0,0.0621351,The intervention increased sleep knowledge post-intervention (b = 1.91; 95%CI: 1.22-2.60) and at follow up (b = 1.40; 95%CI: 0.70-2.10).,"[{'ForeName': 'Maj-Britt M R', 'Initials': 'MMR', 'LastName': 'Inhulsen', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Sarphati Amsterdam, Public Health Service (GGD), City of Amsterdam, De Boelelaan 1085, Amsterdam, 1081HV, The Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Busch', 'Affiliation': 'Sarphati Amsterdam, Public Health Service (GGD), City of Amsterdam, Nieuwe Achtergracht 100, Amsterdam, 1018WT, The Netherlands.'}, {'ForeName': 'Maartje M', 'Initials': 'MM', 'LastName': 'van Stralen', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, De Boelelaan 1085, Amsterdam, 1081HV, The Netherlands.'}]",The Journal of school health,['10.1111/josh.13175']
637,35316080,Long-Term Outcomes and Exploratory Analyses of the Randomized Phase III BILCAP Study.,"PURPOSE


The BILCAP study described a modest benefit for capecitabine as adjuvant therapy for curatively resected biliary tract cancer (BTC), and capecitabine has become the standard of care. We present the long-term data and novel exploratory subgroup analyses.
METHODS


This randomized, controlled, multicenter, phase III study recruited patients age 18 years or older with histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer after resection with curative intent and an Eastern Cooperative Oncology Group performance status of < 2. Patients were randomly assigned 1:1 to receive oral capecitabine (1,250 mg/m 2  twice daily on days 1-14 of a 21-day cycle, for eight cycles) or observation. The primary outcome was overall survival (OS). This study is registered with EudraCT 2005-003318-13.
RESULTS


Between March 15, 2006, and December 4, 2014, 447 patients were enrolled; 223 patients with BTC resected with curative intent were randomly assigned to the capecitabine group and 224 to the observation group. At the data cutoff of January 21, 2021, the median follow-up for all patients was 106 months (95% CI, 98 to 108). In the intention-to-treat analysis, the median OS was 49.6 months (95% CI, 35.1 to 59.1) in the capecitabine group compared with 36.1 months (95% CI, 29.7 to 44.2) in the observation group (adjusted hazard ratio 0.84; 95% CI, 0.67 to 1.06). In a protocol-specified sensitivity analysis, adjusting for minimization factors, nodal status, grade, and sex, the OS hazard ratio was 0.74 (95% CI, 0.59 to 0.94). We further describe the prognostic impact of R status, grade, nodal status, and sex.
CONCLUSION


This long-term analysis supports the previous analysis, suggesting that capecitabine can improve OS in patients with resected BTC when used as adjuvant chemotherapy after surgery and should be considered as the standard of care.",2022,"In the intention-to-treat analysis, the median OS was 49.6 months (95% CI, 35.1 to 59.1) in the capecitabine group compared with 36.1 months (95% CI, 29.7 to 44.2) in the observation group (adjusted hazard ratio 0.84; 95% CI, 0.67 to 1.06).","['registered with EudraCT 2005-003318-13', 'Between March 15, 2006, and December 4, 2014, 447 patients were enrolled; 223 patients with BTC resected with curative intent', 'curatively resected biliary tract cancer (BTC', 'patients age 18 years or older with histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer after resection with curative intent and an Eastern Cooperative Oncology Group performance status of < 2']","['oral capecitabine ', 'capecitabine']","['median OS', 'overall survival (OS']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0153452', 'cui_str': 'Malignant tumor of gallbladder'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",447.0,0.507721,"In the intention-to-treat analysis, the median OS was 49.6 months (95% CI, 35.1 to 59.1) in the capecitabine group compared with 36.1 months (95% CI, 29.7 to 44.2) in the observation group (adjusted hazard ratio 0.84; 95% CI, 0.67 to 1.06).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fletcher', 'Affiliation': 'Cancer Clinical Trials Unit, Birmingham, United Kingdom.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'Molecular and Clinical Cancer Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Hassan Z', 'Initials': 'HZ', 'LastName': 'Malik', 'Affiliation': 'University Hospital Aintree, Liverpool, United Kingdom.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Prasad', 'Affiliation': 'Leeds Teaching Hospital NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Mirza', 'Affiliation': ""Birmingham Woman's and Children's NHS Trust, Birmingham, United Kingdom.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anthony', 'Affiliation': 'Leeds Teaching Hospital NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Corrie', 'Affiliation': 'Cambridge University Hospitals NHS Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'University Hospitals Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Finch-Jones', 'Affiliation': 'University Hospitals Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ross', 'Affiliation': ""Guys and St Thomas's NHS Trust, London, United Kingdom.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wall', 'Affiliation': 'Western General Hospital, Edinburgh, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Cancer Centre, Sheffield, United Kingdom.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Evans', 'Affiliation': 'University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Stocken', 'Affiliation': 'Leeds Institute of Clinical Trials Research, Leeds, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Stubbs', 'Affiliation': 'Cancer Clinical Trials Unit, Birmingham, United Kingdom.'}, {'ForeName': 'Raaj', 'Initials': 'R', 'LastName': 'Praseedom', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Yuk Ting', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'Institute of Immunology and Immunotherapy, Birmingham, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Royal Free Hospital NHS Trust, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Neoptolemos', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'University Hospital Southampton NHS Trust, Southampton, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'O James', 'Initials': 'OJ', 'LastName': 'Garden', 'Affiliation': 'University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Primrose', 'Affiliation': 'University of Southampton, Southampton, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.02568']
638,35322316,"Comparison of decontamination efficacy of two electrolyte cleaning methods to diode laser, plasma, and air-abrasive devices.","OBJECTIVE


To compare the in vitro decontamination efficacy of two electrolytic cleaning methods to diode laser, plasma, and air-abrasive devices.
MATERIAL AND METHODS


Sixty sandblasted large-grit acid-etched (SLA) implants were incubated with 2 ml of human saliva and Tryptic Soy Broth solution under continuous shaking for 14 days. Implants were then randomly assigned to one untreated control group (n = 10) and 5 different decontamination modalities: air-abrasive powder (n = 10), diode laser (n = 10), plasma cleaning (n = 10), and two electrolytic test protocols using either potassium iodide (KI) (n = 10) or sodium formate (CHNaO 2 ) (n = 10) solution. Implants were stained for dead and alive bacteria in two standardized measurement areas, observed at fluorescent microscope, and analyzed for color intensity.
RESULTS


All disinfecting treatment modalities significantly reduced the stained area compared to the untreated control group for both measurement areas (p < 0.001). Among test interventions, electrolytic KI and CHNaO 2  treatments were equally effective, and each one significantly reduced the stained area compared to any other treatment modality (p < 0.001). Efficacy of electrolytic protocols was not affected by the angulation of examined surfaces [surface angulation 0° vs. 60° (staining %): electrolytic cleaning-KI 0.03 ± 0.04 vs. 0.09 ± 0.10; electrolytic cleaning-CHNaO2 0.01 ± 0.01 vs. 0.06 ± 0.08; (p > 0.05)], while air abrasion [surface angulation 0° vs. 60° (staining %): 2.66 ± 0.83 vs. 42.12 ± 3.46 (p < 0.001)] and plasma cleaning [surface angulation 0° vs. 60° (staining %): 33.25 ± 3.01 vs. 39.16 ± 3.15 (p < 0.001)] were.
CONCLUSIONS


Within the limitations of the present in vitro study, electrolytic decontamination with KI and CHNaO 2  was significantly more effective in reducing bacterial stained surface of rough titanium implants than air-abrasive powder, diode laser, and plasma cleaning, regardless of the accessibility of the contaminated implant location.
CLINICAL RELEVANCE


Complete bacterial elimination (residual bacteria < 1%) was achieved only for the electrolytic cleaning approaches, irrespectively of the favorable or unfavorable access to implant surface.",2022,All disinfecting treatment modalities significantly reduced the stained area compared to the untreated control group for both measurement areas (p < 0.001).,['Sixty sandblasted large-grit acid-etched (SLA) implants'],"['electrolytic cleaning methods to diode laser, plasma, and air-abrasive devices', 'untreated control group (n\u2009=\u200910) and 5 different decontamination modalities: air-abrasive powder (n\u2009=\u200910), diode laser (n\u2009=\u200910), plasma cleaning (n\u2009=\u200910), and two electrolytic test protocols using either potassium iodide (KI) (n\u2009=\u200910) or sodium formate (CHNaO 2 ) (n\u2009=\u200910) solution', 'two electrolyte cleaning methods to diode laser, plasma, and air-abrasive devices', '2\xa0ml of human saliva and Tryptic Soy Broth solution']","['air abrasion [surface angulation', 'plasma cleaning [surface angulation 0']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0440273', 'cui_str': 'Grit'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0449876', 'cui_str': 'Test protocol used'}, {'cui': 'C0032831', 'cui_str': 'Potassium Iodide'}, {'cui': 'C0142851', 'cui_str': 'formic acid, sodium salt'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0147083', 'cui_str': 'tryptic soy broth'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",,0.0530415,All disinfecting treatment modalities significantly reduced the stained area compared to the untreated control group for both measurement areas (p < 0.001).,"[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Zipprich', 'Affiliation': ', 64342, Seeheim-Jugenheim, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Weigl', 'Affiliation': 'Department of Postgraduate Education, Faculty of Oral and Dental Medicine, J. W. Goethe University, 60596, Frankfurt am Main, Germany.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Di Gianfilippo', 'Affiliation': 'Department of Periodontics and Oral Medicine, The University of Michigan - School of Dentistry, 1011 North university Avenue, Ann Arbor, MI, 48109, USA. rdgianfi@umich.edu.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Steigmann', 'Affiliation': 'Department of Periodontics and Oral Medicine, The University of Michigan - School of Dentistry, 1011 North university Avenue, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Henrich', 'Affiliation': 'Department of Trauma, Hand & Reconstructive Surgery, Goethe University, 60596, Frankfurt am Main, Germany.'}, {'ForeName': 'Hom-Lay', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, The University of Michigan - School of Dentistry, 1011 North university Avenue, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schlee', 'Affiliation': 'Department of Maxillofacial Surgery, Goethe University, 60596, Frankfurt am Main, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Ratka', 'Affiliation': ', 63477, Maintal, Germany.'}]",Clinical oral investigations,['10.1007/s00784-022-04421-0']
639,35325102,Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial.,"AIMS


In GALACTIC-HF, the cardiac myosin activator omecamtiv mecarbil compared with placebo reduced the risk of heart failure events or cardiovascular death in patients with heart failure with reduced ejection fraction. We explored the influence of atrial fibrillation or flutter (AFF) on the effectiveness of omecamtiv mecarbil.
METHODS AND RESULTS


GALACTIC-HF enrolled patients with New York Heart Association (NYHA) Class II-IV heart failure, left ventricular ejection fraction ≤35%, and elevated natriuretic peptides. We assessed whether the presence or absence of AFF, a pre-specified subgroup, modified the treatment effect for the primary and secondary outcomes, and additionally explored effect modification in patients who were or were not receiving digoxin. Patients with AFF (n = 2245, 27%) were older, more likely to be randomized as an inpatient, less likely to have a history of ischaemic aetiology or myocardial infarction, had a worse NYHA class, worse quality of life, lower estimated glomerular filtration rate, and higher N-terminal pro-B-type natriuretic peptide. The treatment effect of omecamtiv mecarbil was modified by baseline AFF (interaction P = 0.012), with patients without AFF at baseline deriving greater benefit. The worsening of the treatment effect by baseline AFF was significantly more pronounced in digoxin users than in non-users (interaction P = 0.007); there was minimal evidence of effect modification in those patients not using digoxin (P = 0.47) or in digoxin users not in AFF.
CONCLUSION


Patients in AFF at baseline were less likely to benefit from omecamtiv mecarbil than patients without AFF, although the attenuation of the treatment effect was disproportionally concentrated in patients with AFF who were also receiving digoxin.Clinical Trial Registration: NCT02929329.",2022,"The treatment effect of omecamtiv mecarbil was modified by baseline AFF (interaction P = 0.012), with patients without AFF at baseline deriving greater benefit.","['HF enrolled patients with New York Heart Association (NYHA', 'patients with heart failure with reduced ejection fraction', 'heart failure', 'Patients with AFF (n\u2009=\u20092245, 27%) were older, more likely to be randomized as an inpatient, less likely to have a history of ischaemic aetiology or myocardial infarction, had a worse NYHA class, worse quality of life, lower estimated glomerular filtration rate, and higher N-terminal pro-B-type natriuretic peptide']","['omecamtiv mecarbil', 'digoxin', 'placebo', 'atrial fibrillation or flutter (AFF']","['risk of heart failure events or cardiovascular death', 'baseline AFF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C2932035', 'cui_str': 'omecamtiv mecarbil'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.117028,"The treatment effect of omecamtiv mecarbil was modified by baseline AFF (interaction P = 0.012), with patients without AFF at baseline deriving greater benefit.","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Zi Michael', 'Initials': 'ZM', 'LastName': 'Miao', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América (ECLA), Rosario, Argentina.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine and Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation, Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Division of Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Corbalan', 'Affiliation': 'Cardiovascular Division, School of Medicine Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, Athens University Hospital Attikon, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Assen R', 'Initials': 'AR', 'LastName': 'Goudev', 'Affiliation': 'Department of Cardiology, Queen Giovanna University Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Viatcheslav', 'Initials': 'V', 'LastName': 'Mareev', 'Affiliation': 'University Clinic of M.V. Lomonosov Moscow State University, Moscow, Russia.'}, {'ForeName': 'Pranas', 'Initials': 'P', 'LastName': 'Serpytis', 'Affiliation': 'Vilnius University, Medical Faculty, Vilnius, Lithuania.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Suter', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Mehmet B', 'Initials': 'MB', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Cardiology, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Université de Lorraine, Centre Hospitalier Régional Universitaire de Nancy, Inserm CIC, Nancy, France.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Kupfer', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Heitner', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Fady I', 'Initials': 'FI', 'LastName': 'Malik', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}]",European heart journal,['10.1093/eurheartj/ehac144']
640,35325622,"Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial.","BACKGROUND


Non-alcoholic steatohepatitis (NASH) is characterised by hepatic steatosis, inflammation, and injury, and is associated with an increased risk of liver transplantation and death. NASH affects more than 16 million people in the USA, and there is no approved therapy. The aim of this study was to evaluate the safety and efficacy of aldafermin, an engineered analogue of the gut hormone fibroblast growth factor 19 (FGF19).
METHODS


In this randomised, double-blind, placebo-controlled, phase 2b study (ALPINE 2/3) in patients with biopsy-confirmed NASH and stage 2 or 3 fibrosis, we randomly assigned patients stratified by fibrosis stage in a 1:1:1:1 ratio to receive placebo, aldafermin 0·3 mg, 1·0 mg, or 3·0 mg once daily for 24 weeks at 30 study sites in the USA. Patients, investigators, the funder, and all other staff, were masked to treatment assignment throughout the study. The primary endpoint was an improvement in liver fibrosis of at least one stage with no worsening of NASH at week 24. Analyses were done by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT03912532, and has been completed.
FINDINGS


Between May 16, 2019, and Sept 4, 2020, 786 patients were screened, of whom 171 were randomly assigned to a treatment group and included in the intention-to-treat population: 43 in the 0·3 mg aldafermin group, 42 in the 1·0 mg group, 43 in the 3·0 mg group, and 43 in the placebo group. In total, 145 (85%) of patients completed treatment. At week 24, among patients with biopsies at both baseline and week 24, was seven (19%) of 36 patients in the placebo group, 11 (31%) of 36 in the 0·3 mg aldafermin group (difference 90% CI 12% [-9 to 33]; p=0·11), five (15%) of 34 patients in the 1·0 mg group (difference -5% [-24 to 13]; p=0·80), and 11 (30%) of 37 patients in the 3·0 mg group (difference 10% [-9 to 30]; p=0·12) had an improvement in liver fibrosis of at least one stage with no worsening of NASH, without meeting the prespecified significance for dose response (p=0·55). Adverse events were mostly mild or moderate in severity. Diarrhoea occurred in six (14%) of 43 patients in the placebo group, three (7%) of 43 patients in the 0·3 mg aldafermin group, five (12%) of 41 patients in the 1·0 mg group, and ten (23%) of 43 patients in the 3·0 mg group. Incidences of serious adverse events and discontinuations owing to adverse events were similar between groups.
INTERPRETATION


Aldafermin was generally well tolerated but did not produce a significant dose response on fibrosis improvement of at least one stage with no worsening of NASH, despite positive effects on a number of secondary endpoints. The findings of this trial may have implications for the design of future NASH trials.
FUNDING


NGM Biopharmaceuticals.",2022,"Aldafermin was generally well tolerated but did not produce a significant dose response on fibrosis improvement of at least one stage with no worsening of NASH, despite positive effects on a number of secondary endpoints.","['patients with biopsy-confirmed NASH and stage 2 or 3 fibrosis', 'Between May 16, 2019, and Sept 4, 2020, 786 patients were screened, of whom 171', 'patients with non-alcoholic steatohepatitis (ALPINE 2/3']","['placebo, aldafermin 0·3 mg, 1·0 mg, or 3·0 mg once daily for 24 weeks at 30 study sites in the USA', 'placebo', 'Aldafermin', 'NASH', 'aldafermin']","['Diarrhoea', 'liver fibrosis of at least one stage with no worsening of NASH', 'liver fibrosis', 'safety and efficacy', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",786.0,0.581592,"Aldafermin was generally well tolerated but did not produce a significant dose response on fibrosis improvement of at least one stage with no worsening of NASH, despite positive effects on a number of secondary endpoints.","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, UK; Pinnacle Clinical Research, San Antonio, TX, USA.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Division of Gastroenterology and Hepatology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Neff', 'Affiliation': 'Covenant Research, Sarasota, FL, USA.'}, {'ForeName': 'Nadege', 'Initials': 'N', 'LastName': 'Gunn', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX, USA.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Guy', 'Affiliation': 'Department of Pathology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Arizona Liver Health, Tucson, AZ, USA.'}, {'ForeName': 'Mustafa R', 'Initials': 'MR', 'LastName': 'Bashir', 'Affiliation': 'Department of Radiology and Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Freilich', 'Affiliation': 'Kansas City Research Institute, Kansas City, MO, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Arizona Liver Health, Chandler, AZ, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Khazanchi', 'Affiliation': 'Florida Research Institute, Lakewood Ranch, FL, USA.'}, {'ForeName': 'Muhammad Y', 'Initials': 'MY', 'LastName': 'Sheikh', 'Affiliation': 'Fresno Clinical Research Center, Fresno, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Leibowitz', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Rinella', 'Affiliation': 'Department of Medicine (Gastroenterology and Hepatology), Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kipnes', 'Affiliation': 'Diabetes & Glandular Disease Clinic, San Antonio, TX, USA.'}, {'ForeName': 'Sam E', 'Initials': 'SE', 'LastName': 'Moussa', 'Affiliation': 'Adobe Clinical Research, Tucson, AZ, USA.'}, {'ForeName': 'Ziad H', 'Initials': 'ZH', 'LastName': 'Younes', 'Affiliation': 'Gastro One, Germantown, TN, USA.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Bansal', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Baum', 'Affiliation': 'Excel Medical Clinical Trials, Boca Raton, FL, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Borg', 'Affiliation': 'Southern Therapy and Advanced Research, Jackson, MS, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ruane', 'Affiliation': 'Ruane Clinical Research, Los Angeles, CA, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Thuluvath', 'Affiliation': 'Mercy Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Gottwald', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Mujib', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Melchor-Khan', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Alex M', 'Initials': 'AM', 'LastName': 'DePaoli', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA. Electronic address: lling@ngmbio.com.'}, {'ForeName': 'Hsiao D', 'Initials': 'HD', 'LastName': 'Lieu', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, CA, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(22)00017-6']
641,35331018,High-intensity versus low-intensity resistance training in patients with knee osteoarthritis: A randomized controlled trial.,"OBJECTIVES


To assess whether (i) high-intensity resistance training (RT) leads to increased muscle strength compared to low-intensity RT in patients with knee osteoarthritis (OA); and (ii) RT with vitamin D supplementation leads to increased muscle strength compared to placebo in a subgroup with vitamin D deficiency.
DESIGN


Randomized controlled trial.
SETTING


Outpatient rehabilitation centre.
SUBJECTS


Patients with knee OA.
INTERVENTIONS


12 weeks of RT at high-intensity RT (70-80% of 1-repetition maximum (1-RM)) or low-intensity RT (40-50% of 1-RM) and 24 weeks of vitamin D (1200 International units vitamin D3 per day) or placebo supplementation.
MAIN MEASURES


Primary outcome measure was isokinetic muscle strength. Other outcome measure for muscle strength was the estimated 1-RM. Secondary outcome measures were knee pain and physical functioning.
RESULTS


177 participants with a mean age of 67.6 ± 5.8 years were included, of whom 50 had vitamin D deficiency. Isokinetic muscle strength (in Newton metre per kilogram bodyweight) at start, end and 24 weeks after the RT was 0.98 ± 0.40, 1.11 ± 0.40, 1.09 ± 0.42 in the high-intensity group and 1.02 ± 0.41, 1.15 ± 0.42, 1.12 ± 0.40 in the low-intensity group, respectively. No differences were found between the groups, except for the estimated 1-RM in favour of the high-intensity group. In the subgroup with vitamin D deficiency, no difference on isokinetic muscle strength was found between the vitamin D and placebo group.
CONCLUSIONS


High-intensity RT did not result in greater improvements in isokinetic muscle strength, pain and physical functioning compared to low-intensity RT in knee OA, but was well tolerated. Therefore these results suggest that either intensity of resistance training could be utilised in exercise programmes for patients with knee osteoarthritis. No synergistic effect of vitamin D supplementation and RT was found, but this finding was based on underpowered data.",2022,"No differences were found between the groups, except for the estimated 1-RM in favour of the high-intensity group.","['Patients with knee OA', 'Outpatient rehabilitation centre', 'patients with knee osteoarthritis (OA', '177 participants with a mean age of 67.6\u2009±\u20095.8 years were included, of whom 50 had vitamin D deficiency', 'patients with knee osteoarthritis']","['High-intensity versus low-intensity resistance training', 'placebo', 'RT at high-intensity RT', 'vitamin D supplementation', 'vitamin D', 'i) high-intensity resistance training (RT', 'placebo supplementation']","['tolerated', 'isokinetic muscle strength', 'knee pain and physical functioning', 'muscle strength', 'isokinetic muscle strength, pain and physical functioning', 'Isokinetic muscle strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",177.0,0.0839234,"No differences were found between the groups, except for the estimated 1-RM in favour of the high-intensity group.","[{'ForeName': 'Arjan H', 'Initials': 'AH', 'LastName': 'de Zwart', 'Affiliation': 'Reade, Amsterdam Rehabilitation Research Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Rehabilitation Medicine, Amsterdam, the Netherlands.'}, {'ForeName': 'Leo D', 'Initials': 'LD', 'LastName': 'Roorda', 'Affiliation': 'Reade, Amsterdam Rehabilitation Research Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van der Esch', 'Affiliation': 'Reade, Amsterdam Rehabilitation Research Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lips', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Internal Medicine, Endocrine Section, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Natasja M', 'Initials': 'NM', 'LastName': 'van Schoor', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Annemiek C', 'Initials': 'AC', 'LastName': 'Heijboer', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Endocrine Laboratory, Department of Clinical Chemistry, Amsterdam, the Netherlands.'}, {'ForeName': 'Franktien', 'Initials': 'F', 'LastName': 'Turkstra', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Gerritsen', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, Netherlands.'}, {'ForeName': 'Arja', 'Initials': 'A', 'LastName': 'Häkkinen', 'Affiliation': 'Health Sciences in the Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Martjin Pm', 'Initials': 'MP', 'LastName': 'Steultjens', 'Affiliation': '3525Glasgow Caledonian University, School of Health and Life Sciences, Glasgow, UK.'}, {'ForeName': 'Willem F', 'Initials': 'WF', 'LastName': 'Lems', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, Netherlands.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'van der Leeden', 'Affiliation': 'Reade, Amsterdam Rehabilitation Research Centre, Amsterdam, The Netherlands.'}]",Clinical rehabilitation,['10.1177/02692155211073039']
642,35333492,Examining the Impact of Tislelizumab Added to Chemotherapy on Health-Related Quality-of-Life Outcomes in Previously Untreated Patients With Nonsquamous Non-Small Cell Lung Cancer.,"PURPOSE


This study assessed the effects of tislelizumab, a programmed cell death protein 1 inhibitor, in combination with chemotherapy versus chemotherapy alone as first-line treatment on health-related quality of life (HRQoL) in patients with advanced nonsquamous non-small cell lung cancer (nSQ-NSCLC).
METHODS


Patients in this randomized, open-label, multicenter phase III study RATIONALE 304 (NCT03663205) with histologically confirmed stage IIIB/IV nSQ-NSCLC were randomized 2:1 to tislelizumab plus platinum-pemetrexed (arm T + PP) or platinum-pemetrexed alone (arm PP). Health-related QoL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer. Key patient-reported outcome endpoints include mean score change from baseline at weeks 12 (during chemotherapy) and 18 (following chemotherapy) in the 30-item Quality of Life Questionnaire Core's global health status/quality of life (GHS/QoL) and time to deterioration in GHS/QoL.
RESULTS


Three hundred thirty-two patients received at least 1 dose of study drug and completed at least 1 HRQoL assessment. Global health status/QoL score improved in arm T + PP at week 18 (between-group least square mean difference, 5.7; 95% confidence interval [CI], 1.0-10.5; P = 0.018). Patients in arm T + PP experienced greater reduction in coughing (-5.9; 95% CI, -11.6 to -0.1; P = 0.044), dyspnea (-3.8; 95% CI, -7.8 to 0.1; P = 0.059), chest pain (-6.2; 95% CI, -10.8 to -1.6; P = 0.008), and peripheral neuropathy (-2.6; 95% CI, -5.5 to 0.2; P = 0.066). Median time to deterioration in GHS/QoL was not achieved for either arm.
DISCUSSION


The addition of tislelizumab to platinum-based chemotherapy was associated with improvements in nSQ-NSCLC patients' HRQoL as well as the important disease-specific symptoms of coughing, chest pain, and dyspnea.ClinicalTrials.gov Identifier: NCT03663205.",2022,"Global health status/QoL score improved in arm T + PP at week 18 (between-group least square mean difference, 5.7; 95% confidence interval [CI], 1.0-10.5; P = 0.018).","['Previously Untreated Patients With Nonsquamous Non-Small Cell Lung Cancer', 'Patients in this randomized, open-label, multicenter phase III study RATIONALE 304 (NCT03663205) with histologically confirmed stage IIIB/IV nSQ-NSCLC', 'patients with advanced nonsquamous non-small cell lung cancer (nSQ-NSCLC']","['tislelizumab', 'chemotherapy versus chemotherapy', 'tislelizumab plus platinum-pemetrexed (arm T + PP) or platinum-pemetrexed alone (arm PP', 'Tislelizumab Added to Chemotherapy', 'tislelizumab to platinum-based chemotherapy']","['chest pain', 'peripheral neuropathy', 'Health-Related Quality-of-Life Outcomes', 'Median time to deterioration in GHS/QoL', ""30-item Quality of Life Questionnaire Core's global health status/quality of life (GHS/QoL) and time to deterioration in GHS/QoL"", 'health-related quality of life (HRQoL', 'Global health status/QoL score', 'coughing', 'Cancer Quality of Life Questionnaire-Lung Cancer', 'dyspnea']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",332.0,0.233864,"Global health status/QoL score improved in arm T + PP at week 18 (between-group least square mean difference, 5.7; 95% confidence interval [CI], 1.0-10.5; P = 0.018).","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'From the Shanghai Chest Hospital, Jiao Tong University, Shanghai.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Affiliated Tumor Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Gisoo', 'Initials': 'G', 'LastName': 'Barnes', 'Affiliation': 'BeiGene, San Mateo, CA.'}, {'ForeName': 'Xiusong', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'BeiGene (Shanghai) Co, Beijing, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'BeiGene (Shanghai) Co, Beijing, China.'}, {'ForeName': 'Boxiong', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'BeiGene, San Mateo, CA.'}]","Cancer journal (Sudbury, Mass.)",['10.1097/PPO.0000000000000583']
643,35344464,"Safety and immunogenicity of 3 formulations of a Sabin inactivated poliovirus vaccine produced on the PER.C6® cell line: A phase 2, double-blind, randomized, controlled study in infants vaccinated at 6, 10 and 14 weeks of age.","An inactivated poliovirus vaccine candidate using Sabin strains (sIPV) grown on the PER.C6® cell line was assessed in infants after demonstrated immunogenicity and safety in adults. The study recruited 300 infants who were randomized (1:1:1:1) to receive one of 3 dose levels of sIPV or a conventional IPV based on Salk strains (cIPV). Poliovirus-neutralizing antibodies were measured before the first dose and 28 days after the third dose. Reactogenicity was assessed for 7 days and unsolicited adverse events (AEs) for 28 days after each vaccination. Serious AEs (SAEs) were recorded throughout the study. Solicited AEs were mostly mild to moderate. None of the SAEs reported in the study were judged vaccine related, including one fatal SAE due to aspiration of vomitus that occurred 26 days after the third dose of low-dose sIPV. After 3 sIPV vaccinations and across all dose levels, seroconversion (SC) rates were at least 92% against Sabin poliovirus types and at least 80% against Salk types, with a dose-response in neutralizing antibody geometric mean titers (GMTs) observed across the 3 sIPV groups. Compared to cIPV, the 3 sIPV groups displayed similar or higher SC rates and GMTs against the 3 Sabin types but showed a lower response against Salk types 1 and 2; this was most visible for Salk type 1. While the PER.C6® cell line-based sIPV showed an acceptable safety profile and immunogenicity in infants, lower seroprotection against type 1 warrants optimization of dose level and additional clinical evaluation.",2022,"Compared to cIPV, the 3 sIPV groups displayed similar or higher SC rates and GMTs against the 3 Sabin types but showed a lower response against Salk types 1 and 2; this was most visible for Salk type 1.","['infants vaccinated at 6, 10 and 14 weeks of age', '300 infants']","['sIPV or a conventional IPV based on Salk strains (cIPV', 'Sabin inactivated poliovirus vaccine', 'PER.C6']","['seroconversion (SC) rates', 'Poliovirus-neutralizing antibodies', 'Reactogenicity', 'Safety and immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",300.0,0.249187,"Compared to cIPV, the 3 sIPV groups displayed similar or higher SC rates and GMTs against the 3 Sabin types but showed a lower response against Salk types 1 and 2; this was most visible for Salk type 1.","[{'ForeName': 'Anna Lisa', 'Initials': 'AL', 'LastName': 'Ong-Lim', 'Affiliation': 'Philippine General Hospital, University of the Philippines Manila, Manila, Philippines.'}, {'ForeName': 'Georgi', 'Initials': 'G', 'LastName': 'Shukarev', 'Affiliation': 'Janssen Vaccines AG, Bern, Switzerland.'}, {'ForeName': 'Mitzi', 'Initials': 'M', 'LastName': 'Trinidad-Aseron', 'Affiliation': 'De La Salle University Medical Center, Cavite, Philippines.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Caparas-Yu', 'Affiliation': 'De La Salle Medical and Health Sciences Institute, Cavite, Philippines.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Greijer', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Duchene', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Scheper', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Vitalija', 'Initials': 'V', 'LastName': 'van Paassen', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Le Gars', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Conor P', 'Initials': 'CP', 'LastName': 'Cahill', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Macaya', 'Initials': 'M', 'LastName': 'Douoguih', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}, {'ForeName': 'Jeanne-Marie', 'Initials': 'JM', 'LastName': 'Jacquet', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2044255']
644,35358015,The eight-year long-term follow-up on the effectiveness of the quadrivalent human papillomavirus vaccine in Chinese women 20-45 years of age.,"The quadrivalent human papillomavirus (4vHPV) vaccine has shown confirmative effectiveness in preventing HPV-related diseases among women and men around the globe. The phase III, randomized, double-blind efficacy study (Base study, NCT00834106) conducted in China showed 100% efficacy against HPV 16/18-related cervical intraepithelial neoplasia and efficacy against HPV persistent infection for 78 months. Participants aged 20-45 years who received three doses of 4vHPV vaccine or placebo during the base study were selected and invited for this long-term follow-up (LTFU) study to assess the long-term effectiveness of the 4vHPV vaccine in preventing HPV-related diseases. A total of 368 participants were included in this LTFU study with a median follow-up of 94 months. Among 27 participants (Vaccine vs. Placebo: 8 vs. 19) who underwent colposcopy and biopsy due to cervical cytological abnormalities or HPV infection, no HPV-16/18-related cases of cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN) was observed in the vaccine group while two HPV-16-related cases (CIN1/VaIN) were observed in the placebo group. There were another two HPV-related cases (non-vaccine HPV types) found in the placebo group. Consistent with the findings from global studies that suggested long-term efficacy of 4vHPV vaccine, our study showed continued protective effect of 4vHPV vaccine against HPV-related precancerous diseases through a median follow-up time of 94 months with the longest follow-up time of 125 months after completing three doses of vaccination among Chinese women 20-45 years of age.",2022,The quadrivalent human papillomavirus (4vHPV) vaccine has shown confirmative effectiveness in preventing HPV-related diseases among women and men around the globe.,"['A total of 368 participants were included in this LTFU study with a median follow-up of 94\u2009months', '27 participants ', 'Participants aged 20-45\u2009years who received three doses of', 'Chinese women 20-45\u2009years of age', 'Chinese women 20-45 years of age']","['4vHPV vaccine or placebo', 'quadrivalent human papillomavirus vaccine', 'Vaccine vs. Placebo', '4vHPV vaccine', 'placebo']","['cervical cytological abnormalities or HPV infection, no HPV-16/18-related cases of cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN', 'cervical intraepithelial neoplasia and efficacy against HPV persistent infection']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}, {'cui': 'C0346210', 'cui_str': 'Dysplasia of vulva'}, {'cui': 'C0346208', 'cui_str': 'Vaginal intraepithelial neoplasia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}]",368.0,0.177336,The quadrivalent human papillomavirus (4vHPV) vaccine has shown confirmative effectiveness in preventing HPV-related diseases among women and men around the globe.,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jingran', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Mingzhu', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Obstetrics and Gynecology, Shunyi Maternity and Child Health Hospital, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Mi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shunyi Maternity and Child Health Hospital, Beijing, China.'}, {'ForeName': 'Su Yi', 'Initials': 'SY', 'LastName': 'La Tu', 'Affiliation': 'Department of Obstetrics and Gynecology, Xilinguolemeng Xianghuangqi Maternity and Child Health Hospital, Inner Mongolia Autonomous Region, China.'}, {'ForeName': 'Danhua', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Linhong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""National Center for Women and Children's Health, Chinese Center for Disease Control and Prevention, Beijing, China.""}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.""}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2052700']
645,34879902,Comorbid obstructive sleep apnea and insomnia and its associations with mood and diabetes-related distress in type 2 diabetes mellitus.,"STUDY OBJECTIVES


Previous research suggests that obstructive sleep apnea (OSA) and insomnia frequently coexist and are prevalent in persons with type 2 diabetes mellitus. This study compared mood and diabetes-related distress among OSA, insomnia, and comorbid OSA and insomnia groups in persons with type 2 diabetes mellitus.
METHODS


A secondary analysis was conducted with baseline data from 2 independent randomized controlled trials evaluating the efficacy of OSA and insomnia treatment. The pooled sample (n = 224) included participants with OSA only (n = 68 [30.4%]), insomnia only (n = 107 [47.8%]), and OSA and insomnia (OSA+insomnia; n = 49 [21.9%]). OSA was defined as an apnea-hypopnea index ≥ 15 events/h; insomnia was defined as an Insomnia Severity Index score ≥ 15. Mood was measured by the Profile of Mood States total and subscale scores; diabetes-related distress was assessed by the Problem Areas in Diabetes questionnaire. One-way analysis of covariance and multivariate analysis of covariance were conducted, controlling for demographic characteristics and restless legs syndrome.
RESULTS


The insomnia group had on average significantly higher scores for total mood disturbance (insomnia vs OSA = 45.32 vs 32.15,  P  = .049), tension-anxiety (insomnia vs OSA = 12.64 vs 9.47,  P  = .008), and confusion-bewilderment (insomnia vs OSA = 9.45 vs 7.46,  P  = .036) than the OSA group. The OSA+insomnia group had on average significantly greater diabetes-related distress than the OSA group (OSA+insomnia vs OSA = 40.61 vs 30.97,  P  = .036).
CONCLUSIONS


Insomnia may have greater impact on mood disturbance and diabetes-related distress than OSA in persons with type 2 diabetes mellitus. In particular, comorbid insomnia may contribute to greater diabetes-related distress in persons with type 2 diabetes mellitus and OSA.
CITATION


Jeon B, Luyster FS, Sereika SM, DiNardo MM, Callan JA, Chasens ER. Comorbid obstructive sleep apnea and insomnia and its associations with mood and diabetes-related distress in type 2 diabetes mellitus.  J Clin Sleep Med . 2022;18(4):1103-1111.",2022,"The insomnia group had on average significantly higher scores for total mood disturbance (insomnia vs OSA = 45.32 vs 32.15,  P  = .049), tension-anxiety (insomnia vs OSA = 12.64 vs 9.47,  P  = .008), and confusion-bewilderment (insomnia vs OSA = 9.45 vs 7.46,  P  = .036) than the OSA group.","['type 2 diabetes mellitus', 'persons with type 2 diabetes mellitus and OSA', 'persons with type 2 diabetes mellitus', 'pooled sample (n\u2009=\u2009224) included participants with OSA only (n\u2009=\u200968 [30.4%]), insomnia only (n\u2009=\u2009107 [47.8%]), and OSA and insomnia (OSA+insomnia; n\u2009=\u200949 [21.9']",[],"['Profile of Mood States total and subscale scores; diabetes-related distress', 'total mood disturbance', 'tension-anxiety', 'OSA', 'Comorbid obstructive sleep apnea and insomnia', 'diabetes-related distress']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",[],"[{'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",,0.0459156,"The insomnia group had on average significantly higher scores for total mood disturbance (insomnia vs OSA = 45.32 vs 32.15,  P  = .049), tension-anxiety (insomnia vs OSA = 12.64 vs 9.47,  P  = .008), and confusion-bewilderment (insomnia vs OSA = 9.45 vs 7.46,  P  = .036) than the OSA group.","[{'ForeName': 'Bomin', 'Initials': 'B', 'LastName': 'Jeon', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Faith S', 'Initials': 'FS', 'LastName': 'Luyster', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'DiNardo', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Callan', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Eileen R', 'Initials': 'ER', 'LastName': 'Chasens', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9812']
646,34870586,The effectiveness of an individualized sleep and shift work education and coaching program to manage shift work disorder in nurses: a randomized controlled trial.,"STUDY OBJECTIVES


While insomnia and sleepiness symptoms are common in shift workers, 20%-30% experience more severe symptoms and meet the criteria for shift work disorder (SWD). SWD can lead to impairments in cognitive function, physical and mental health, and reduced productivity and increased risk of workplace injury. The aim of this study was to deliver and evaluate a shift work individual management coaching program, focusing on sleep education, promoting good sleep hygiene, and providing individualized behavioral strategies to cope with shift schedules.
METHODS


A clustered randomized controlled trial of sleep education and sleep disorders screening was undertaken, based on hospital wards at a tertiary hospital in Melbourne, Australia. Participants identified as high risk for SWD underwent one of two 8-week programs, a shift work individualized management program, or an active control. The primary outcome was ward-based sick leave. Secondary outcomes were SWD risk, sleep hygiene, insomnia, depression, and anxiety. A total of 149 nurses, across 16 wards (96% female, 34.66 ± 11.99 years) completed both baseline and follow-up questionnaires (23.9% were high risk SWD).
RESULTS


There was no significant reduction in sick leave between intervention and control wards (mean difference = 1.2 days,  P  = .063). Improvements were seen in insomnia ( P  < .0001) and depression (intervention,  P  ≤ .0001, control,  P  = .023) in both groups, but were not significantly different between programs. Anxiety ( P  = .001. control  P  = .079) and Functional Outcomes of Sleep Questionnaire 10 ( P  = .001 control  P  = .056) improved only for the intervention.
CONCLUSIONS


This SWD intervention trial did not reduce sick leave compared to the active control but there was an improvement. Improvements in sleep hygiene, insomnia, depression, and anxiety severity were seen for both groups. Future intervention trials should consider including both sleep and mental health interventions, strategies to avoid between group contamination and the duration of programs for optimal behavioral modification.
CLINICAL TRIAL REGISTRATION


Registry: Australian New Zealand Clinical Trials Registry; Name: Sleep Health Management for Healthcare Workers; URL: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12616000369426; Identifier: ACTRN12616000369426.
CITATION


Booker LA, Sletten TL, Barnes M, et al. The effectiveness of an individualized sleep and shift work education and coaching program to manage shift work disorder in nurses: a randomized controlled trial.  J Clin Sleep Med . 2022;18(4):1035-1045.",2022,"Improvements were seen in insomnia ( P  < .0001) and depression (intervention,  P  ≤ .0001, control,  P  = .023) in both groups, but were not significantly different between programs.","['hospital wards at a tertiary hospital in Melbourne, Australia', 'A total of 149 nurses, across 16 wards (96% female, 34.66 ± 11.99 years) completed both baseline and follow-up questionnaires (23.9% were high risk SWD', 'nurses', 'Participants identified as high risk for SWD']","['SWD', 'sleep education and sleep disorders screening', 'individualized sleep and shift work education and coaching program']","['cognitive function, physical and mental health', 'sleep hygiene, insomnia, depression, and anxiety severity', 'ward-based sick leave', 'insomnia', 'Anxiety', 'Functional Outcomes of Sleep Questionnaire', 'severe symptoms and meet the criteria for shift work disorder (SWD', 'sick leave', 'SWD risk, sleep hygiene, insomnia, depression, and anxiety']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4087539', 'cui_str': 'Shift work disorder'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C4087539', 'cui_str': 'Shift work disorder'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4087539', 'cui_str': 'Shift work disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0540693,"Improvements were seen in insomnia ( P  < .0001) and depression (intervention,  P  ≤ .0001, control,  P  = .023) in both groups, but were not significantly different between programs.","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Booker', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Sletten', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Barnes', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Alvaro', 'Affiliation': 'Alfred Health, Psychiatry Inpatient Operations, Prahran, Victoria Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Collins', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'Adelaide Institute for Sleep Health: A Flinders Centre of Research Excellence, Flinders University, South Australia, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'McMahon', 'Affiliation': 'Institute for Breathing and Sleep, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Melbourne, Australia.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences Monash University, Clayton, Victoria, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9782']
647,34870584,Cannabis use as a moderator of cognitive behavioral therapy for insomnia.,"STUDY OBJECTIVES


Cannabis use is common among young adults and has been proposed as a potential treatment for insomnia. However, controlled studies examining the impact of cannabis use on insomnia symptoms are rare. This secondary analysis of published trial data tested cannabis use during cognitive behavioral treatment for insomnia (CBT-I) as a moderator of treatment efficacy.
METHODS


Young adults (ages 18-30 years) who reported past-month binge drinking (4/5+ drinks for women/men) and met diagnostic criteria for insomnia disorder were randomized to CBT-I (n = 28) or sleep hygiene (n = 28) groups. Interaction effects were tested using multilevel models. Outcomes included insomnia severity, actigraphy-assessed sleep efficiency, diary-assessed sleep quality, drinking quantity, and alcohol-related consequences.
RESULTS


Twenty-six participants (46%; 12 in the sleep hygiene group and 14 in the CBT-I group) reported using cannabis during the treatment phase of the study, on an average of 23% of treatment days (range, 3%-100%). Relative to those who did not use cannabis, participants who used cannabis during treatment reported heavier drinking and more frequent cigarette use. Approximately 1 in 4 cannabis users (27%) reported using cannabis to help with sleep; however, cannabis users and nonusers did not differ in the use of alcohol as a sleep aid. Controlling for sex, race, drinking quantity, cigarette use, symptoms of depression, and symptoms of anxiety, use of cannabis during treatment did not moderate CBT-I effects on insomnia severity ( b , -.002;  p  = .99) or other outcomes (all  p  > .20).
CONCLUSIONS


CBT-I is effective in reducing insomnia symptoms among young adult drinkers with insomnia, regardless of cannabis use.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: The Insomnia Treatment and Problems (iTAP) Study; URL: https://clinicaltrials.gov/ct2/show/NCT03627832; Identifier: NCT03627832.
CITATION


Miller MB, Carpenter RW, Freeman LK, Curtis AF, Yurasek AM, McCrae CS. Cannabis use as a moderator of cognitive behavioral therapy for insomnia.  J Clin Sleep Med.  2022;18(4):1047-1054.",2022,"Relative to those who did not use cannabis, participants who used cannabis during treatment reported heavier drinking and more frequent cigarette use.","['young adult drinkers with insomnia, regardless of cannabis use', 'young adults', 'Young adults (ages 18-30 years) who reported past-month binge drinking (4/5+ drinks for women/men) and met diagnostic criteria for insomnia disorder']","['CBT-I (n\u2009=\u200928) or sleep hygiene', 'cognitive behavioral therapy', 'CBT-I']","['sex, race, drinking quantity, cigarette use, symptoms of depression, and symptoms of anxiety, use of cannabis', 'Insomnia Treatment and Problems', 'insomnia severity, actigraphy-assessed sleep efficiency, diary-assessed sleep quality, drinking quantity, and alcohol-related consequences', 'insomnia severity', 'insomnia symptoms', 'heavier drinking']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]",,0.0263076,"Relative to those who did not use cannabis, participants who used cannabis during treatment reported heavier drinking and more frequent cigarette use.","[{'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, Columbia, Missouri.'}, {'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychological Sciences, University of Missouri-St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Lindsey K', 'Initials': 'LK', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, Columbia, Missouri.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, Columbia, Missouri.'}, {'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Yurasek', 'Affiliation': 'Health Education and Behavior Department, College of Health and Human Performance, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, Columbia, Missouri.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9796']
648,35363563,"The Impact of Caffeine Intake on Mental Health Symptoms in Postmenopausal Females with Overactive Bladder Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial.","Background:  Caffeine has been associated with a dose-dependent variety of mental health changes, which have been found to precede or be a complication of overactive bladder (OAB) symptoms after menopause. The current study examines the effects of low and moderate caffeine intake on anxiety, depression, sleep, and stress in postmenopausal females with OAB.  Materials and Methods:  Eighty-one females were randomized in a prospective, double-blind, placebo-controlled study. Participants were allocated to 200 mg/day caffeine, 400 mg/day caffeine, and placebo capsules for 1 week each in a crossover design and evaluated using validated mental health questionnaires. Symptoms during each treatment phase were measured using Beck Anxiety and Depression Inventory, Insomnia Severity Index, and Perceived Stress Scale. Linear regression models were used to examine the impact of low (200 mg/day) and moderate (400 mg/day) dose of caffeine and placebo on mental health.  Results:  Fifty-six female participants finished the study. The mean age was 69.2 years (58.0-84.0 years). Two females dropped out during the treatment phase with 400 mg/day caffeine intake due to side effects associated with headaches and nausea. Moderate dose of caffeine showed a small positive effect on mental health, specifically a decrease in anxiety during 7 days of exposure ( p  < 0.05).  Conclusions:  Moderate caffeine use may decrease anxiety in postmenopausal patients with underlying OAB, whereas depression, insomnia, and perceived stress were not affected by low-to-moderate caffeine intake. Our results support that counseling efforts on moderate caffeine consumption in postmenopausal patients underline that low-to moderate caffeine intake may be appropriate and possibly beneficial unless contraindicated due to other underlying conditions. Clinical Trials Registration: clinicaltrials.gov (NCT02180048).",2022,"Moderate dose of caffeine showed a small positive effect on mental health, specifically a decrease in anxiety during 7 days of exposure ( p  < 0.05).  ","['postmenopausal patients', 'postmenopausal females with OAB', 'postmenopausal patients with underlying OAB', 'Materials and Methods:  Eighty-one females', 'Fifty-six female participants finished the study', 'Postmenopausal Females with Overactive Bladder Symptoms', 'The mean age was 69.2 years (58.0-84.0 years']","['caffeine and placebo', 'Caffeine', 'caffeine, 400\u2009mg/day caffeine, and placebo', 'caffeine', 'low and moderate caffeine intake', 'Placebo', 'Caffeine Intake', 'placebo']","['headaches and nausea', 'Beck Anxiety and Depression Inventory, Insomnia Severity Index, and Perceived Stress Scale', 'anxiety, depression, sleep, and stress', 'mental health', 'anxiety', 'Mental Health Symptoms']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",56.0,0.122825,"Moderate dose of caffeine showed a small positive effect on mental health, specifically a decrease in anxiety during 7 days of exposure ( p  < 0.05).  ","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Staack', 'Affiliation': 'Department of Urology, Loma Linda University Health, Loma Linda, California, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Distelberg', 'Affiliation': 'Department of Counseling and Family Sciences, School of Behavioral Health, Loma Linda University, Loma Linda, California, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Moldovan', 'Affiliation': 'Department of Psychology, PIH Health, Whittier, California, USA.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Belay', 'Affiliation': 'Department of Urology, Loma Linda University Health, Loma Linda, California, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Sabaté', 'Affiliation': 'Department of Nutrition, School of Public Health, Loma Linda University, Loma Linda, California, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2021.0467']
649,35365594,"The effect of menaquinone-7 supplementation on dp-ucMGP, PIVKAII, inflammatory markers, and body composition in type 2 diabetes patients: a randomized clinical trial.","BACKGROUND


Type 2 diabetes mellitus (T2DM) is a common disorder that is characterized by chronic hyperglycemia and chronic inflammation, which also have a reinforcing effect on each other. The present research studied the effects of menaquinone (MK-7) supplementation on serum dp-ucMGP (dephospho uncarboxylated Matrix Gla Protein), PIVKAII (Prothrombin Induced by Vitamin K Absence), inflammatory markers and body composition indices in type 2 diabetes mellitus (T2DM) patients.
METHODS


This 12-week double-blind placebo-controlled randomized clinical trial allocated 60 T2DM patients equally into a MK-7 (200 mcg/day) group or a placebo group. All patients also received dietary advice at the beginning of study and their dietary intakes were checked using a 3-day food record. The body composition of each patient was also measured and their vitamin K status was assessed using the ELISA method to measure serum dp-ucMGP and PIVKAII. In addition, inflammatory status indices were also measured, including hsCRP (high-sensitivity C-reactive protein), IL-6 (interleukin-6) and TNF-α (tumor necrosis factor alpha). All measurements were made both before and after the intervention period.
RESULTS


In total 45 patients completed the trial (MK-7 group = 23 and placebo group = 22). The calorie and macronutrient intake of the two groups were similar pre and post intervention. There were statistically significant increases in dietary vitamin K intake for both groups over the course of the study (p < 0.05), but the intergroup differences were not significant. The body composition indices (i.e., body fat percentage, fat mass, fat free mass, muscle mass, bone mass and total body water) were not significantly different between groups or across the trial. The serum levels of the vitamin K markers, PIVKAII and dp-ucMGP, decreased significantly in the MK-7 group over the course of the study (p < 0.05), but there was no decrease in the placebo group. However, after adjusting for the baseline levels and changes in vitamin K intake, the between group differences were only significant for PIVKAII (p < 0.05). Following the intervention, the serum levels of the inflammatory markers (hsCRP, IL-6, and TNF-α) were significantly lower in the MK-7 group (p < 0.05), but not in the placebo group. However, the between group differences in the inflammatory markers were not statistically significant.
CONCLUSIONS


Although further studies are needed, it appears that MK-7 supplementation can be effective in improving PIVKAII levels, but not for improving dp-ucMGP, inflammatory status or the body composition indices of T2DM patients.
TRIAL REGISTRATION NUMBER


This study was prospectively registered at the Iranian Registry of Clinical Trials on the 20th of May 2019 (ID: IRCT20100123003140N22).",2022,"Following the intervention, the serum levels of the inflammatory markers (hsCRP, IL-6, and TNF-α) were significantly lower in the MK-7 group (p < 0.05), but not in the placebo group.","['type 2 diabetes patients', 'type 2 diabetes mellitus (T2DM) patients', '60 T2DM patients equally into a']","['menaquinone-7 supplementation', 'uncarboxylated Matrix Gla Protein), PIVKAII (Prothrombin', 'placebo', 'MK-7', 'menaquinone (MK-7) supplementation']","['inflammatory markers', 'dietary vitamin K intake', 'dp-ucMGP, PIVKAII, inflammatory markers, and body composition', 'body composition indices (i.e., body fat percentage, fat mass, fat free mass, muscle mass, bone mass and total body water', 'hsCRP (high-sensitivity C-reactive protein), IL-6', 'interleukin-6) and TNF-α (tumor necrosis factor alpha', 'inflammatory markers and body composition', 'serum levels of the vitamin K markers, PIVKAII and dp-ucMGP', 'vitamin K intake', 'vitamin K status', 'serum dp-ucMGP (dephospho', 'calorie and macronutrient intake', 'serum levels of the inflammatory markers (hsCRP, IL-6, and TNF-α']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0078382', 'cui_str': 'vitamin MK 7'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0065752', 'cui_str': 'matrix Gla protein'}, {'cui': 'C1113704', 'cui_str': 'Protein induced by vitamin K absence or antagonist II'}, {'cui': 'C0033706', 'cui_str': 'Prothrombin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086605', 'cui_str': 'Vitamin K 2'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C1113704', 'cui_str': 'Protein induced by vitamin K absence or antagonist II'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",60.0,0.113761,"Following the intervention, the serum levels of the inflammatory markers (hsCRP, IL-6, and TNF-α) were significantly lower in the MK-7 group (p < 0.05), but not in the placebo group.","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Karamzad', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Faraji', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Adeli', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mark J M', 'Initials': 'MJM', 'LastName': 'Sullman', 'Affiliation': 'Department of Life and Health Sciences, University of Nicosia, Nicosia, Cyprus.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Pourghassem Gargari', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. bahrampg@yahoo.com.'}]",Nutrition & diabetes,['10.1038/s41387-022-00192-5']
650,35369705,Effect of Vupanorsen on Non-High-Density Lipoprotein Cholesterol Levels in Statin-Treated Patients With Elevated Cholesterol: TRANSLATE-TIMI 70.,"BACKGROUND


Genetic loss-of-function variants in  ANGPTL3  are associated with lower levels of plasma lipids. Vupanorsen is a hepatically targeted antisense oligonucleotide that inhibits Angiopoietin-like 3 (ANGPTL3) protein synthesis.
METHODS


Adults with non-high-density lipoprotein cholesterol (non-HDL-C) ≥100 mg/dL and triglycerides 150 to 500 mg/dL on statin therapy were randomized in a double-blind fashion to placebo or 1 of 7 vupanorsen dose regimens (80, 120, or 160 mg SC every 4 weeks, or 60, 80, 120, or 160 mg SC every 2 weeks). The primary end point was placebo-adjusted percentage change from baseline in non-HDL-C at 24 weeks. Secondary end points included placebo-adjusted percentage changes from baseline in triglycerides, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and ANGPTL3.
RESULTS


Two hundred eighty-six subjects were randomized: 44 to placebo and 242 to vupanorsen. The median age was 64 (interquartile range, 58-69) years, 44% were female, the median non-HDL-C was 132.4 (interquartile range, 118.0-154.1) mg/dL, and the median triglycerides were 216.2 (interquartile range, 181.4-270.4) mg/dL. Vupanorsen resulted in significant decreases from baseline over placebo in non-HDL-C ranging from 22.0% in the 60 mg every 2 weeks arm to 27.7% in the 80 mg every 2 weeks arm (all  P <0.001 for all doses). There were dose-dependent reductions in triglycerides that ranged from 41.3% to 56.8% (all  P <0.001). The effects on LDL-C and ApoB were more modest (7.9%-16.0% and 6.0%-15.1%, respectively) and without a clear dose-response relationship' and only the higher reductions achieved statistical significance. ANGPTL3 levels were decreased in a dose-dependent manner by 69.9% to 95.2% (all  P <0.001). There were no confirmed instances of significant decline in renal function or platelet count with vupanorsen. Injection site reactions and >3× elevations of alanine aminotransferase or aspartate aminotransferase were more common at higher total monthly doses (up to 33.3% and 44.4%, respectively), and there was a dose-dependent increase in hepatic fat fraction (up to 76%).
CONCLUSIONS


Vupanorsen administered at monthly equivalent doses from 80 to 320 mg significantly reduced non-HDL-C and additional lipid parameters. Injection site reactions and liver enzyme elevations were more frequent at higher doses, and there was a dose-dependent increase in hepatic fat fraction.
REGISTRATION


URL: https://clinicaltrials.gov; Unique identifier: NCT04516291.",2022,"Injection site reactions and >3x elevations of alanine aminotransferase or aspartate aminotransferase were more common at higher total monthly doses (up to 33.3% and 44.4%, respectively), and there was a dose-dependent increase in hepatic fat fraction (up to 76%).  ","['Two hundred eighty-six subjects were randomized: 44 to', 'Statin-Treated Patients With Elevated Cholesterol', 'Adults with non-high-density lipoprotein cholesterol']","['placebo', 'Vupanorsen']","['non-HDL-C and additional lipid parameters', 'Non-High-Density Lipoprotein Cholesterol Levels', 'renal function or platelet count', 'Injection site reactions and liver enzyme elevations', 'LDL-C and ApoB', 'hepatic fat fraction', 'median triglycerides', 'alanine aminotransferase or aspartate aminotransferase', 'triglycerides', 'ANGPTL3 levels', 'placebo-adjusted percentage changes from baseline in triglycerides, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and ANGPTL3.  Results']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",286.0,0.207621,"Injection site reactions and >3x elevations of alanine aminotransferase or aspartate aminotransferase were more common at higher total monthly doses (up to 33.3% and 44.4%, respectively), and there was a dose-dependent increase in hepatic fat fraction (up to 76%).  ","[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Marston', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).""}, {'ForeName': 'Candace R', 'Initials': 'CR', 'LastName': 'Bramson', 'Affiliation': 'Pfizer, Inc, New York, NY (C.R.B., M.C., V.R., S.G.T.).'}, {'ForeName': 'Madelyn', 'Initials': 'M', 'LastName': 'Curto', 'Affiliation': 'Pfizer, Inc, New York, NY (C.R.B., M.C., V.R., S.G.T.).'}, {'ForeName': 'Vesper', 'Initials': 'V', 'LastName': 'Ramos', 'Affiliation': 'Pfizer, Inc, New York, NY (C.R.B., M.C., V.R., S.G.T.).'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jevne', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).""}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Surgery, University of Toronto, Canada (S.V.).'}, {'ForeName': 'Wojtek', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Medical University of Silesia, Katowice, Poland (W.W.).'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer, Inc, New York, NY (C.R.B., M.C., V.R., S.G.T.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., N.A.M., A.J., J.F.K., J.-G.P., S.A.M., M.S.S., S.D.W.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.122.059266']
651,35363812,Impact of fatigue at the shoulder on the contralateral upper limb kinematics and performance.,"BACKGROUND


Altered movement patterns have been proposed as an etiological factor for the development of musculoskeletal pain. Fatigue influences upper limb kinematics and movement performance which could extend to the contralateral limb and potentially increasing risk of injury. The aim of this study was to investigate the impact of fatigue at the dominant arm on the contralateral upper limb movement.
METHODS


Forty participants were randomly assigned to one of two groups: Control or Fatigue Group. All participants completed a reaching task at the baseline and post-experimental phase, during which they reached four targets with their non-dominant arm in a virtual reality environment. Following the baseline phase, the Fatigue Group completed a shoulder fatigue protocol with their dominant arm only, while the Control Group took a 10-minute break. Thereafter, the reaching task was repeated. Upper limb and trunk kinematics (joint angles and excursions), spatiotemporal (speed and accuracy) and surface electromyographic (sEMG) activity (sEMG signal mean epoch amplitude and median frequency of the EMG power spectrum) were collected. Two-way repeated-measures ANOVA were performed to determine the effects of Time, Group and of the interaction between these factors.
RESULTS


There was a significant Time x Group interaction for sternoclavicular elevation range of motion (p = 0.040), movement speed (p = 0.043) and accuracy (p = 0.033). The Fatigue group showed higher contralateral sternoclavicular elevation and increased movement error while experiencing fatigue in the dominant arm. Moreover, the Control group increased their speed during the Post-experimental phase compared to baseline (p = 0.043), while the Fatigue group did not show any speed improvement. There was no EMG sign of fatigue in any of the muscles evaluated.
CONCLUSION


This study showed that fatigue at the dominant shoulder impacts movement at the contralateral upper limb. Such changes may be a risk factor for the development of shoulder pain in both the fatigued and non-fatigued limbs.",2022,"There was a significant Time x Group interaction for sternoclavicular elevation range of motion (p = 0.040), movement speed (p = 0.043) and accuracy (p = 0.033).",['Forty participants'],['Control or Fatigue Group'],"['movement speed', 'EMG sign of fatigue', 'Upper limb and trunk kinematics (joint angles and excursions), spatiotemporal (speed and accuracy) and surface electromyographic (sEMG) activity (sEMG signal mean epoch amplitude and median frequency of the EMG power spectrum', 'sternoclavicular elevation range of motion', 'contralateral sternoclavicular elevation and increased movement error while experiencing fatigue']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",40.0,0.103159,"There was a significant Time x Group interaction for sternoclavicular elevation range of motion (p = 0.040), movement speed (p = 0.043) and accuracy (p = 0.033).","[{'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Dupuis', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sole', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mercier', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Roy', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}]",PloS one,['10.1371/journal.pone.0266370']
652,35331787,Associations of parent dietary role modeling with children's diet quality in a rural setting: Baseline data from the NU-HOME study.,"These analyses examined associations of parent dietary role modeling with diet quality among school-age children in a rural community. Past research has found protective associations between parent role modeling and children's dietary intake; however, there is a gap in understanding these associations for families in rural communities. Baseline data (2017 -2018) were drawn from the New Ulm at Home (NU-HOME) randomized controlled trial, conducted in the United States. The trial recruited 114 children (7-10 years old) and parents. Parents self-reported dietary intake [fruit and vegetable (FV), sugar-sweetened beverage (SSB), fast food (FF)] and frequency of sitting and eating with their child. Children reported parent role modeling of healthful eating (FV and salad at the evening meal; FV as snacks). Two 24-h dietary recalls assessed child diet quality indicators [Healthy Eating Index-2015 (HEI-2015) total scores, FV intake, SSB intake]. General linear models (GLM) and logistic regression analyzed associations of child diet quality (HEI score, FV intake, SSB intake) with parent dietary intake, parent sitting and eating the evening meal with their child, and child perceptions of parent role modeling healthful eating, adjusted for highest level of education in the home. Higher child HEI-2015 scores were positively associated with more frequent parent role modeling of fruit intake at meals, and inversely associated with more frequent parent role modeling of fruit as a snack; no significant associations of child FV intake with parent role modeling were observed. Higher child SSB intake was positively associated with parent FF intake. In this rural community, parents play significant roles in shaping children's dietary quality and intake, though more work needs to be done to address optimal intervention strategies to promote parent role modeling of healthful eating.",2022,"Higher child HEI-2015 scores were positively associated with more frequent parent role modeling of fruit intake at meals, and inversely associated with more frequent parent role modeling of fruit as a snack; no significant associations of child FV intake with parent role modeling were observed.","[""children's diet quality in a rural setting"", 'families in rural communities', '114 children (7-10 years old) and parents', 'school-age children in a rural community']",[],"['Higher child HEI-2015 scores', 'child FV intake', 'Higher child SSB intake', 'child diet quality indicators [Healthy Eating Index-2015 (HEI-2015) total scores, FV intake, SSB intake', 'child diet quality (HEI score, FV intake, SSB intake) with parent dietary intake, parent sitting and eating the evening meal with their child, and child perceptions of parent role modeling healthful eating', 'Parents self-reported dietary intake [fruit and vegetable (FV), sugar-sweetened beverage (SSB), fast food (FF)] and frequency of sitting and eating with their child']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0585040', 'cui_str': 'Evening meal'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",114.0,0.0419035,"Higher child HEI-2015 scores were positively associated with more frequent parent role modeling of fruit intake at meals, and inversely associated with more frequent parent role modeling of fruit as a snack; no significant associations of child FV intake with parent role modeling were observed.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Linde', 'Affiliation': 'Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis MN, 55454, USA. Electronic address: linde074@umn.edu.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Horning Dehmer', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis MN, 55455, USA.'}, {'ForeName': 'Jiwoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis MN, 55455, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friend', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis MN, 55455, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Flattum', 'Affiliation': 'Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis MN, 55454, USA.'}, {'ForeName': 'Chrisa', 'Initials': 'C', 'LastName': 'Arcan', 'Affiliation': 'Department of Family Medicine and Population Health, Division of Epidemiology, Virginia Commonwealth University, Richmond VA, 23284, USA.'}, {'ForeName': 'Jayne A', 'Initials': 'JA', 'LastName': 'Fulkerson', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis MN, 55455, USA.'}]",Appetite,['10.1016/j.appet.2022.106007']
653,35337884,Supporting family meal frequency: Screening Phase results from the Simply Dinner Study.,"We aimed to test main, additive, interactive effects, and feasibility of all possible combinations of six intervention components implemented for 8 weeks (Cooking/Serving Resources; Meal Delivery; Ingredient Delivery; Community Kitchen; Nutrition Education; Cooking Demonstrations). Primary outcomes were family meal frequency and preschoolers' dietary quality; secondary outcomes included family meal preparation type, meal preparation barriers, family functioning, and kitchen inventory adequacy. All possible intervention combinations were tested using a randomized factorial trial design in the first phase of a Multiphase Optimization Strategy (MOST). Feasibility was assessed via attendance, delivery logs, and satisfaction. Parent-reported data collection included: socio-demographics, frequency and type of family meals; preschooler dietary intake; perceived barriers to meal planning and preparation; assessment of family functioning; and a kitchen inventory of materials generally needed for meal preparation. Participants (n = 499) were recruited at two Head Start agencies in mid-Michigan with data collection and delivery of some intervention components in participants' homes. Promising intervention bundles were identified by evaluating pre-to post-intervention effect sizes. The combination of Cooking/Serving Resources and Meal Delivery increased family meal frequency (Cohen's d = 0.17), cooking dinner from scratch (d = 0.21), prioritization of family meals (d = 0.23), and kitchen inventory (d = 0.46) and decreased use/consumption of ready-made (d = -0.18) and fast foods (d = -0.23). Effects on diet quality were in the expected direction but effect sizes were negligible. Community Kitchen, Nutrition Education, and Cooking Demonstration showed poor feasibility due to low attendance while Ingredient Delivery was infeasible due to staffing challenges related to its labor intensity. Additionally, although not one of our pre-specified outcomes, Cooking/Serving Resources (RR = 0.74) and Meal Delivery (RR = 0.73) each decreased food insecurity. Cooking/Serving Resources combined with Meal Delivery showed promise as a strategy for increasing family meal frequency.",2022,"The combination of Cooking/Serving Resources and Meal Delivery increased family meal frequency (Cohen's d = 0.17), cooking dinner from scratch (d = 0.21), prioritization of family meals (d = 0.23), and kitchen inventory (d = 0.46) and decreased use/consumption of ready-made (d = -0.18) and fast foods (d = -0.23).","[""Participants (n\u202f=\u202f499) were recruited at two Head Start agencies in mid-Michigan with data collection and delivery of some intervention components in participants' homes""]",['Cooking/Serving Resources combined with Meal Delivery'],"['via attendance, delivery logs, and satisfaction', 'diet quality', 'Meal Delivery', ""family meal frequency and preschoolers' dietary quality; secondary outcomes included family meal preparation type, meal preparation barriers, family functioning, and kitchen inventory adequacy""]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4553624', 'cui_str': 'With meals'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",499.0,0.0379335,"The combination of Cooking/Serving Resources and Meal Delivery increased family meal frequency (Cohen's d = 0.17), cooking dinner from scratch (d = 0.21), prioritization of family meals (d = 0.23), and kitchen inventory (d = 0.46) and decreased use/consumption of ready-made (d = -0.18) and fast foods (d = -0.23).","[{'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Kerver', 'Affiliation': 'Department of Epidemiology and Biostatistics, Michigan State University, 909 Wilson Road, East Lansing, MI, 48824, USA. Electronic address: kerverje@msu.edu.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Brophy-Herb', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, 552 W Circle Drive, East Lansing, MI, 48824, USA. Electronic address: hbrophy@msu.edu.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Sturza', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, USA. Electronic address: jmigrin@umich.edu.'}, {'ForeName': 'Mildred A', 'Initials': 'MA', 'LastName': 'Horodynski', 'Affiliation': 'College of Nursing, Michigan State University, 1355 Bogue St, East Lansing, MI, 48824, USA. Electronic address: millie@msu.edu.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Contreras', 'Affiliation': 'Michigan State University Extension, Michigan State University, East Lansing, MI, 48824, USA. Electronic address: contrer7@msu.edu.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, 552 W Circle Drive, East Lansing, MI, 48824, USA. Electronic address: steint@msu.edu.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Garner', 'Affiliation': 'Michigan State University Extension, Michigan State University, East Lansing, MI, 48824, USA. Electronic address: prineeri@msu.edu.'}, {'ForeName': 'Sheilah', 'Initials': 'S', 'LastName': 'Hebert', 'Affiliation': 'Michigan State University Extension, Michigan State University, East Lansing, MI, 48824, USA. Electronic address: murphysh@msu.edu.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, 552 W Circle Drive, East Lansing, MI, 48824, USA. Electronic address: will3208@msu.edu.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Kaciroti', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA. Electronic address: nicola@med.umich.edu.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Martoccio', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA. Electronic address: tiffany.martoccio@gmail.com.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Van Egeren', 'Affiliation': 'University Outreach and Engagement, Michigan State University, East Lansing, MI, 48824, USA. Electronic address: vanegere@msu.edu.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Department of Human Development and Family Studies, Missouri State University, Springfield, MO, USA. Electronic address: choihy15@msu.edu.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Institution, Louisiana State University, Baton Rouge, LA, USA. Electronic address: corby.martin@pbrc.edu.'}, {'ForeName': 'Koi', 'Initials': 'K', 'LastName': 'Mitchell', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, 552 W Circle Drive, East Lansing, MI, 48824, USA. Electronic address: mitch777@msu.edu.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Dalimonte-Merckling', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, 552 W Circle Drive, East Lansing, MI, 48824, USA. Electronic address: dalimonte.d@gmail.com.'}, {'ForeName': 'L Alexandra', 'Initials': 'LA', 'LastName': 'Jeanpierre', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, USA. Electronic address: ajeanp@umich.edu.'}, {'ForeName': 'Chelsea A', 'Initials': 'CA', 'LastName': 'Robinson', 'Affiliation': 'Department of Epidemiology and Biostatistics, Michigan State University, 909 Wilson Road, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Lumeng', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, USA; Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor, MI, USA. Electronic address: jlumeng@umich.edu.'}]",Appetite,['10.1016/j.appet.2022.106009']
654,35337743,Effects of Landiolol on Macrocirculatory Parameters and Left and Right Ventricular Performances Following Cardiac Surgery: A Randomized Controlled Trial.,"OBJECTIVES


Postoperative atrial fibrillation (POAF) is a major complication after cardiac surgery, and an early postoperative introduction of beta-blockers is recommended to reduce its incidence. Landiolol, a new intravenous short-acting beta-1 blocker, could present a useful and safe macrohemodynamic profile after cardiac surgery. Detailed metabolic and hemodynamic effects of landiolol on cardiac performance, however, remain poorly documented. The authors aimed to investigate the dose-dependent hemodynamic and metabolic effects of landiolol in that specific setting.
DESIGN


A prospective, randomized, double-blind study versus placebo.
SETTING


A tertiary university hospital.
PARTICIPANTS


Adult patients scheduled for elective cardiac surgery with cardiopulmonary bypass.
INTERVENTIONS


Incremental doses of intravenous landiolol (0.5, 1, 2, 5, and 10 μg/kg/min) were given within the 2 hours after arrival in the intensive care unit. Macrocirculatory parameters and cardiac performances were derived from transpulmonary thermodilution and transthoracic echocardiography. Metabolic data were obtained from arterial blood tests.
MEASUREMENTS AND MAIN RESULTS


From January to November 2019, 58 patients were analyzed and divided into a landiolol group (n = 30) and a control group (n = 28). Heart rate significantly decreased in the landiolol group (p < 0.01), whereas mean arterial pressure and stroke volume remained unchanged. No significant modification was found in both left and right systolic and diastolic performances. Metabolic variables were similar in both groups. New-onset POAF occurred in 9 (32%) versus 5 (17%) patients in the control and landiolol groups, respectively (p = 0.28).
CONCLUSIONS


Infusion of landiolol in the range of 0.5-to-10 μg/kg/min during the early postoperative period presents a good macrohemodynamic safety profile in cardiac surgical patients and could be useful to prevent POAF.",2022,"Heart rate significantly decreased in the landiolol group (p < 0.01), whereas mean arterial pressure and stroke volume remained unchanged.","['A tertiary university hospital', 'Cardiac Surgery', 'cardiac surgical patients', 'From January to November 2019, 58 patients', 'Adult patients scheduled for elective cardiac surgery with cardiopulmonary bypass']","['landiolol', 'Landiolol', 'intravenous landiolol', 'placebo']","['Metabolic variables', 'Macrocirculatory Parameters and Left and Right Ventricular Performances', 'left and right systolic and diastolic performances', 'Heart rate', 'mean arterial pressure and stroke volume', 'New-onset POAF']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",58.0,0.101431,"Heart rate significantly decreased in the landiolol group (p < 0.01), whereas mean arterial pressure and stroke volume remained unchanged.","[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Ferraris', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France. Electronic address: arnaud.ferraris@chu-lyon.fr.""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Jacquet-Lagrèze', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France; Laboratoire CarMeN, INSERM1060, Faculté de Médecine Lyon Est, Lyon, France.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Cazenave', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fornier', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Wajma', 'Initials': 'W', 'LastName': 'Jalalzai', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rousseau-Saine', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pozzi', 'Affiliation': 'Laboratoire CarMeN, INSERM1060, Faculté de Médecine Lyon Est, Lyon, France; Service de Chirurgie Cardiaque, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Fellahi', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France; Laboratoire CarMeN, INSERM1060, Faculté de Médecine Lyon Est, Lyon, France.""}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2022.02.016']
655,35341666,Whole Blood Adsorber During CPB and Need for Vasoactive Treatment After Valve Surgery in Acute Endocarditis: A Randomized Controlled Study.,"OBJECTIVES


Patients with endocarditis requiring urgent valvular surgery with cardiopulmonary bypass are at a high risk of developing systemic inflammatory response syndrome and septic shock, necessitating intensive use of vasopressors after surgery. The use of a cytokine hemoadsorber (CytoSorb, CytoSorbents Europe GmbH, Germany) during cardiac surgery has been suggested to reduce the risk of inflammatory activation. The study authors hypothesized that adding a cytokine adsorber would reduce cytokine burden, which would translate into improved hemodynamic stability.
DESIGN


A randomized, controlled, nonblinded clinical trial.
SETTING


At a university hospital, tertiary referral center.
PARTICIPANTS


Nineteen patients with endocarditis undergoing valve surgery.
INTERVENTION


A cytokine hemoadsorber integrated into the cardiopulmonary bypass circuit.
MEASUREMENTS AND MAIN RESULTS


The accumulated norepinephrine dose in the intervention group was half or less at all postoperative time points compared to the control group, although it did not reach statistical significance; at 24 and 48 hours (median 36 [25-75 percentiles; 12-57] μg v 114 [25-559] μg, p = 0.11 and 36 [12-99] μg v 261 [25-689] μg, p = 0.09). There was no significant difference in chest tube output, but there was a significantly lower need for the transfusion of red blood cells (285 [0-657] mL v 1,940 [883-2,148] mL, p = 0.03).
CONCLUSIONS


There was no statistically significant difference between the groups with regard to vasopressor use after surgery for endocarditis with the use of a cytokine hemoadsorber during cardiopulmonary bypass. Additional, larger randomized controlled trials are needed to definitely assess the potential effect.",2022,There was no statistically significant difference between the groups with regard to vasopressor use after surgery for endocarditis with the use of a cytokine hemoadsorber during cardiopulmonary bypass.,"['Nineteen patients with endocarditis undergoing valve surgery', 'Acute Endocarditis', 'At a university hospital, tertiary referral center', 'Patients with endocarditis requiring urgent valvular surgery with cardiopulmonary bypass are at a high risk of developing systemic inflammatory response syndrome and septic shock, necessitating intensive use of vasopressors after surgery']",['Vasoactive Treatment'],"['transfusion of red blood cells', 'chest tube output']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014118', 'cui_str': 'Endocarditis'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0375268', 'cui_str': 'Acute endocarditis'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",19.0,0.152282,There was no statistically significant difference between the groups with regard to vasopressor use after surgery for endocarditis with the use of a cytokine hemoadsorber during cardiopulmonary bypass.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Holmén', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Corderfeldt', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Lannemyr', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Anesthesia and Intensive Care, Institution of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dellgren', 'Affiliation': 'The Transplant Institute, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Hansson', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Electronic address: emma.hansson@vgregion.se.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2022.02.028']
656,35343620,Two-year outcomes of low-exposure extended-release tacrolimus and mycophenolate mofetil regimen in de novo kidney transplantation: A multi-center randomized controlled trial.,"BACKGROUND


Once-daily extended-release tacrolimus (TACER) is commonly administered following kidney transplantation (KTx); however, its optimal dosage remains unknown.
METHODS


In this multi-center, randomized controlled trial, 62 living donor KTx recipients were assigned to either standard-exposure (SE; n = 32) or low-exposure (LE; n = 30) TACER (Graceptor®, Astellas Pharm Inc.) groups. All patients received basiliximab and mycophenolate mofetil (MMF). The primary outcomes were acute rejection, graft/patient survival, and the secondary outcomes were incidence of cytomegalovirus infection, and de novo donor-specific antibodies (dnDSA) production.
RESULTS


The tacrolimus trough level and estimated area under the blood concentration-time curve (eAUC) were significantly higher in SE than in LE (SE vs. LE; 1 year: 5.0 ± 0.9 ng/ml and 206.9 ± 26.8 ng h/ml vs. 3.4 ± 1.0 ng/ml and 153.9 ± 26.4 ng h/ml; 2 years: 4.8 ± 1.0 ng/ml and 204.9 ± 30.1 ng h/ml vs. 3.8 ± 0.9 ng/ml and 164.4 ± 27.0 ng h/ml). In contrast, the dosage and eAUC of MMF did not differ between groups. Two-year graft and patient survival rates were 100% in both groups, and acute rejection rates were 0% and 10% in the SE and LE, respectively (p = 0.11). The mean estimated glomerular filtration rates did not differ between the groups. Cytomegalovirus infection was slightly lower in the LE (SE: 12.5% and LE: 6.7%, p = 0.37). In the LE, four cases of dnDSA were noted within 2 years of transplantation; no case was observed in the SE (p = 0.034).
CONCLUSIONS


Although the LE TACER regimen showed similar rates of acute rejection, as well as graft and patient survival compared with SE after KTx, LE was significantly more associated with dnDSA. Further investigation of its long-term effect on graft survival is warranted. (University Hospital Medical Information Network Clinical Trials Registry ID: UMIN000033089).",2022,The tacrolimus trough level and estimated area under the blood concentration-time curve (eAUC) were significantly higher in SE than in LE (SE vs LE; one year: 5.0 ± 0.9 ng/mL and 206.9 ± 26.8 ngཥh/mL vs 3.4 ± 1.0 ng/mL and 153.9 ± 26.4 ngཥh/mL; two years: 4.8 ± 1.0 ng/mL and 204.9 ± 30.1 ngཥh/mL vs 3.8 ± 0.9 ng/mL and 164.4 ± 27.0 ngཥh/mL).,"['62 living donor KTx recipients', 'De Novo Kidney Transplantation']","['tacrolimus (TACER', 'standard-exposure (SE; n = 32) or low-exposure (LE; n = 30) TACER (Graceptor®, Astellas Pharm Inc', 'basiliximab and mycophenolate mofetil (MMF', 'Low-Exposure Extended-Release Tacrolimus and Mycophenolate Mofetil Regimen']","['acute rejection rates', 'patient survival rates', 'glomerular filtration rates', 'graft survival', 'tacrolimus trough level and estimated area under the blood concentration-time curve (eAUC', 'incidence of cytomegalovirus infection, and de novo donor-specific antibodies (dnDSA) production', 'rates of acute rejection', 'Cytomegalovirus infection', 'graft and patient survival', 'acute rejection, graft/patient survival']","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",62.0,0.344523,The tacrolimus trough level and estimated area under the blood concentration-time curve (eAUC) were significantly higher in SE than in LE (SE vs LE; one year: 5.0 ± 0.9 ng/mL and 206.9 ± 26.8 ngཥh/mL vs 3.4 ± 1.0 ng/mL and 153.9 ± 26.4 ngཥh/mL; two years: 4.8 ± 1.0 ng/mL and 204.9 ± 30.1 ngཥh/mL vs 3.8 ± 0.9 ng/mL and 164.4 ± 27.0 ngཥh/mL).,"[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Hidaka', 'Affiliation': 'Department of Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Goto', 'Affiliation': 'Department of Transplant Nephrology and Transplant Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Shigeyoshi', 'Initials': 'S', 'LastName': 'Yamanaga', 'Affiliation': 'Department of Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Kawabata', 'Affiliation': 'Department of Nephrology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Toyoda', 'Affiliation': 'Department of Nephrology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Toshihide', 'Initials': 'T', 'LastName': 'Tomosugi', 'Affiliation': 'Department of Transplant Nephrology and Transplant Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Futamura', 'Affiliation': 'Department of Transplant Nephrology and Transplant Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Transplant Nephrology and Transplant Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tsujita', 'Affiliation': 'Department of Transplant Nephrology and Transplant Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hiramitsu', 'Affiliation': 'Department of Transplant Nephrology and Transplant Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yokomizo', 'Affiliation': 'Department of Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Miyata', 'Affiliation': 'Department of Nephrology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Narumi', 'Affiliation': 'Department of Transplant Nephrology and Transplant Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Renal Transplant Surgery, Aichi Medical University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Watarai', 'Affiliation': 'Department of Transplant Nephrology and Transplant Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.'}]",Clinical transplantation,['10.1111/ctr.14655']
657,35352382,Inclusion of unexposed clusters improves the precision of fixed effects analysis of stepped-wedge cluster randomized trials.,"Stepped-wedge cluster randomized trials (SW-CRTs) are typically analyzed using mixed effects models. The fixed effects model is a useful alternative that controls for all time-invariant cluster-level confounders and has proper control of type I error when the number of clusters is small. In principle, all clusters in SW-CRTs are designed to eventually receive the intervention, but in real-world research, some trials can end with unexposed clusters (clusters that never received the intervention), such as when a trial is terminated early based on interim analysis results. Typically, unexposed clusters are expected to contribute no information to the fixed effects intervention effect estimator and are excluded from fixed effects analyses. In this article we mathematically prove that inclusion of unexposed clusters improves the precision of the fixed effects least squares dummy variable (LSDV) intervention effect estimator, re-analyze data from a recent SW-CRT of a novel palliative care intervention containing an unexposed cluster, and evaluate the methods by simulation. We found that including unexposed clusters improves the precision of the fixed effects LSDV intervention effect estimator in both real and simulated datasets. Our simulations also reveal an increase in power and decrease in root mean square error. These improvements are present even if the assumptions of constant residual variance and period effects are violated. In the case that a SW-CRT concludes with unexposed clusters, these unexposed clusters can be included in the fixed effects LSDV analysis to improve precision, power, and root mean square error.",2022,We found that including unexposed clusters improves the precision of the fixed effects LSDV intervention effect estimator in both real and simulated datasets.,[],[],['root mean square error'],[],[],"[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}]",,0.0543383,We found that including unexposed clusters improves the precision of the fixed effects LSDV intervention effect estimator in both real and simulated datasets.,"[{'ForeName': 'Kenneth Menglin', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Xiangmei', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Grace Meijuan', 'Initials': 'GM', 'LastName': 'Yang', 'Affiliation': 'Division of Supportive and Palliative Care, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}]",Statistics in medicine,['10.1002/sim.9394']
658,35353915,Effect of additional acupuncture to pelvic floor exercise on urinary incontinence: A randomized controlled trial.,"AIMS


To investigate the additional benefit of acupuncture to pelvic floor exercise (PFE) on the improvement of urinary incontinence (UI) and quality of life (QoL) in women.
METHODS


This was a single-blinded randomized controlled trial in a tertiary university hospital. Women with UI in various severity and types were randomized to receive either a weekly course of acupuncture with PFE or PFE alone for 6 weeks and then followed up for 24 weeks in every 6 weeks. Investigators were blinded to group allocation in pre- and postintervention assessments. Primary outcome was subjective changes of UI symptoms at 24 weeks. Secondary outcomes were episodes and severity of UI from bladder diary, severity by Visual Analogue Scale, and QoL scores by validated Chinese short-form of Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7).
RESULTS


One hundred seventy-nine women were screened while 137 were randomized. Significant subjective improvement in UI symptoms was demonstrated at all follow-up, latest at 24 weeks (odds ratio [OR]: 2.29, 95% confidence Interval [CI]: 1.02-5.12, respectively), with reduced episodes and severity of UI after (p < 0.05), and a trend of improvement in IIQ-7 score (p = 0.05). No major adverse events occurred. History of 2 years or longer duration of UI symptoms was associated with lower effectiveness of acupuncture (OR: 0.08, 95% CI: 0.01-0.68).",2022,"History of 2 years or longer duration of UI symptoms was associated with lower effectiveness of acupuncture (OR: 0.08, 95% CI: 0.01-0.68).","['One hundred\xa0seventy-nine women were screened while 137 were randomized', 'Women with UI in various severity and types', 'tertiary university hospital', 'women']","['acupuncture to pelvic floor exercise', 'acupuncture', 'acupuncture to pelvic floor exercise (PFE', 'acupuncture with PFE or PFE alone']","['urinary incontinence (UI) and quality of life (QoL', 'UI symptoms', 'subjective changes of UI symptoms', 'longer duration of UI symptoms', 'episodes and severity of UI from bladder diary, severity by Visual Analogue Scale, and QoL scores by validated Chinese short-form of Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7', 'urinary incontinence', 'IIQ-7 score', 'reduced episodes and severity of UI']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}]","[{'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",179.0,0.356588,"History of 2 years or longer duration of UI symptoms was associated with lower effectiveness of acupuncture (OR: 0.08, 95% CI: 0.01-0.68).","[{'ForeName': 'Osanna Y K', 'Initials': 'OYK', 'LastName': 'Wan', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Rachel Y K', 'Initials': 'RYK', 'LastName': 'Cheung', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Michelle P M', 'Initials': 'MPM', 'LastName': 'Law', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for Health Education and Health Promotion, The Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Lai Loi', 'Initials': 'LL', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Ronald Chi Chiu', 'Initials': 'RCC', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Symphorosa S C', 'Initials': 'SSC', 'LastName': 'Chan', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}]",Neurourology and urodynamics,['10.1002/nau.24918']
659,35365369,Ready for SDM- evaluation of an interprofessional training module in shared decision making - A cluster randomized trial.,"OBJECTIVE


Ready for SDM was developed in Norway as a comprehensive modularized curriculum for health care providers (HCP). The current study evaluated the efficacy of one of the modules, a 2-hour interprofessional SDM training designed to enhance SDM competencies.
METHODS


A cluster randomized controlled trial was conducted with eight District Psychiatric Centres randomized to wait-list control (CG) or intervention group (IG). Participants and trainers were not blinded to their allocation. The IG received a 2-hour didactic and interactive training, using video examples. The primary outcome was the agreement between the participants' and an expert assessment of patient involvement in a video recorded consultation. The SDM-knowledge score was a secondary outcome.
RESULTS


Compared to the CG (n = 65), the IG (n = 69) judged involvement behavior in a communication example more accurately (mean difference of weighted T, adjusted for age and gender:=-0.098, p = 0.028) and demonstrated better knowledge (mean difference=-0.58; p = 0.014). A sensitivity analysis entering a random effect for cluster turned out not significant.
CONCLUSION


The interprofessional group training can improve HCPs' SDM-competencies.
PRACTICE IMPLICATIONS


Addressing interprofessional teams using SDM communication training could supplement existing SDM training approaches. More research is needed to evaluate the training module's effects as a component of large-scale implementation of SDM.",2022,"Compared to the CG (n = 65), the IG (n = 69) judged involvement behavior in a communication example more accurately (mean difference of weighted T, adjusted for age and gender:=-0.098, p = 0.028) and demonstrated better knowledge",['eight District Psychiatric Centres'],"['2-hour didactic and interactive training', 'CG', 'interprofessional SDM training', 'wait-list control (CG) or intervention group (IG']","['knowledge', 'SDM-knowledge score', 'expert assessment of patient involvement in a video recorded consultation']","[{'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030699', 'cui_str': 'Client participation'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",69.0,0.0401198,"Compared to the CG (n = 65), the IG (n = 69) judged involvement behavior in a communication example more accurately (mean difference of weighted T, adjusted for age and gender:=-0.098, p = 0.028) and demonstrated better knowledge","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kienlin', 'Affiliation': 'Faculty of Health Sciences, Department of Health and Caring Sciences, UiT The Arctic University of Norway, Postbox 6050, Langnes, Norway; E-Health, Integrative care and Innovation Center, University Hospital of North Norway HF, Postbox 100, 9038 Tromsø, Norway; The South-Eastern Norway Regional Health Authority, Department of Medicine and Healthcare, Postbox 404, N-2303 Hamar, Norway. Electronic address: simone.maria.kienlin@uit.no.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'School of Nursing, University of Ottawa, 451 Smyth Road, Ottawa, ON K1H 8M5, Canada and: Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada. Electronic address: Dawn.Stacey@uottawa.ca.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'University of Oslo, Faculty of Medicine, Postbox 1072, Blindern, N-0316 Oslo, Norway. Electronic address: kari.nytroen@medisin.uio.no.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Grafe', 'Affiliation': 'MSH Medical School Hamburg - University of Applied Sciences and Medical University, Germany. Electronic address: alex_grafe@yahoo.fr.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kasper', 'Affiliation': 'Faculty of Health Sciences, Department of Nursing and Health Promotion, OsloMet, Metropolitan University, Pilestredet 46, 0167 Oslo, Norway. Electronic address: jurgenka@oslomet.no.'}]",Patient education and counseling,['10.1016/j.pec.2022.03.013']
660,35363799,A mindfulness-based stress management program for caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients: Protocol for a randomized controlled trial.,"OBJECTIVES


Caregivers of allogeneic hematopoietic stem cell transplant (HCT) cancer patients experience high caregiver burden and carry a significant amount of responsibility. Mindfulness has the potential to lessen caregiver burden by aiding in stress management. To date, no studies have examined the efficacy of mindfulness in reducing caregiver burden in this population. Based on our pilot study demonstrating initial feasibility and acceptability of FOCUS (Focusing On mindfulness for Caregivers Under Stress), this 3-arm randomized controlled trial aims to examine the efficacy of a 6-week mindfulness-based stress management program for allogeneic HCT caregivers. Hypotheses include that the FOCUS condition will have lower post-treatment caregiver burden and that patients of these caregivers will have better patient health outcomes compared to other treatment conditions.
METHOD


Eligible caregivers will be randomly assigned to one of three treatment conditions: FOCUS, Healthy Living (HL; active control), and Enhanced Care (EC; usual care). Caregivers in FOCUS and HL will participate in 6-week weekly individual treatment sessions and will be sent brief daily momentary interventions/messages. Caregivers in all conditions will complete daily diaries over the course of treatment. Patients of enrolled caregivers will be enrolled for assessments only. Participants will complete assessments at baseline, end of treatment, 2- and 6-months post-treatment. Biomarker data will be collected via hair cortisol concentrations from caregivers at baseline and 6 months post-treatment.
RESULTS


Recruitment is ongoing.
CONCLUSIONS


The data collected from this study will provide evidence on the efficacy of mindfulness in alleviating HCT caregiver stress and impacting patient health outcomes.
TRIAL REGISTRATION


The current study is registered in clinicaltrials.gov (NCT05078229); see https://clinicaltrials.gov/ct2/show/NCT05078229?term=christine+vinci&draw=2&rank=1.",2022,"Hypotheses include that the FOCUS condition will have lower post-treatment caregiver burden and that patients of these caregivers will have better patient health outcomes compared to other treatment conditions.
","['Eligible caregivers', 'caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients', 'Caregivers of allogeneic hematopoietic stem cell transplant (HCT) cancer patients experience high caregiver burden', 'allogeneic HCT caregivers', 'Caregivers Under Stress']","['6-week mindfulness-based stress management program', 'FOCUS', 'Healthy Living (HL; active control), and Enhanced Care (EC; usual care', 'mindfulness-based stress management program']",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.303115,"Hypotheses include that the FOCUS condition will have lower post-treatment caregiver burden and that patients of these caregivers will have better patient health outcomes compared to other treatment conditions.
","[{'ForeName': 'Min-Jeong', 'Initials': 'MJ', 'LastName': 'Yang', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, United States of America.'}, {'ForeName': 'Valerie V', 'Initials': 'VV', 'LastName': 'Yepez', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, United States of America.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, United States of America.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Reblin', 'Affiliation': 'College of Medicine, University of Vermont, Burlington, Vermont, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pidala', 'Affiliation': 'Department of Blood & Marrow Transplantation, Moffitt Cancer Center, Tampa, Florida, United States of America.'}, {'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, United States of America.'}, {'ForeName': 'Jerrold S', 'Initials': 'JS', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Massachusetts, Amherst, Massachusetts, United States of America.'}, {'ForeName': 'L Robert', 'Initials': 'LR', 'LastName': 'Gore', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, United States of America.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Khera', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona, United States of America.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Lau', 'Affiliation': 'Department of Social Work, Moffitt Cancer Center, Tampa, Florida, United States of America.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Sauls', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, United States of America.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Jones', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, United States of America.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vinci', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, United States of America.'}]",PloS one,['10.1371/journal.pone.0266316']
661,35361168,Effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +): a stepped wedge study protocol.,"BACKGROUND


People with mental illness have a reduced life expectancy compared to the general population. Despite the increasing evidence for the efficacy of lifestyle interventions there is little change in routine clinical care. This discrepancy is often referred to as the implementation gap and has caused a need for effectiveness and implementation research in real-world settings. Our study assesses the effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +).
METHODS


An open cohort stepped wedge cluster randomized trial in inpatients psychiatric wards of GGz Centraal, the Netherlands. The wards are divided into three clusters based on geographical region. These clusters are randomly allocated to one of the three pre-defined steps to integrate MULTI + . MULTI + can be tailored to fit individual psychiatric wards and includes 10 core components aimed at improving lifestyle factors. The primary outcome is to investigate the difference in the mean QRISK3 score of patients receiving MULTI + compared to patients receiving TAU. Secondary outcomes include somatic and mental health outcomes, lifestyle factors, and implementation factors. Findings will be analysed using mixed model analyses.
DISCUSSION


The MULTI + study is the first large-scale study evaluating the long-term effects of a multidisciplinary, multicomponent approach aimed at improving lifestyle factors in routine inpatient mental health care. A limitation of this study is the risk of missing data due to the large-scale, real-world setting of this study. Furthermore, implementation monitoring and external events that may influence outcomes could be difficult to account for. Strengths of this study are the focus on effectiveness as well as implementation and the inclusion of both patient and health care professionals' perspectives. Effectiveness studies in routine clinical care can advance our knowledge on lifestyle interventions in real-world settings.
TRIAL REGISTRATION


ClinicalTrials.gov registration. Identifier: NCT04922749 . Retrospectively registered 3th of June 2021.",2022,"Our study assesses the effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +).
","['People with mental illness', 'inpatients with mental illness (MULTI\u2009', 'routine inpatient mental health care', 'inpatients psychiatric wards of GGz Centraal, the Netherlands']",['multidisciplinary lifestyle focused approach'],"['somatic and mental health outcomes, lifestyle factors, and implementation factors', 'mean QRISK3']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0285211,"Our study assesses the effectiveness and implementation of a multidisciplinary lifestyle focused approach in the treatment of inpatients with mental illness (MULTI +).
","[{'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'den Bleijker', 'Affiliation': 'Scientific Research Department, GGz Centraal, Amersfoort, the Netherlands.'}, {'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'van Schothorst', 'Affiliation': 'Scientific Research Department, GGz Centraal, Amersfoort, the Netherlands. m.vanschothorst@ggzcentraal.nl.'}, {'ForeName': 'I J M', 'Initials': 'IJM', 'LastName': 'Hendriksen', 'Affiliation': 'LivIng Active, Santpoort-Zuid, the Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cahn', 'Affiliation': 'Department of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'de Vries', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'van Harten', 'Affiliation': 'Scientific Research Department, GGz Centraal, Amersfoort, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Deenik', 'Affiliation': 'Scientific Research Department, GGz Centraal, Amersfoort, the Netherlands.'}]",BMC psychiatry,['10.1186/s12888-022-03801-w']
662,35377919,Novel GxE effects and resilience: A case:control longitudinal study of psychosocial stress with war-affected youth.,"Responses to early life adversity differ greatly across individuals. Elucidating which factors underlie this variation can help us better understand how to improve health trajectories. Here we used a case:control study of refugee and non-refugee youth, differentially exposed to war-related trauma, to investigate the effects of genetics and psychosocial environment on response to trauma. We investigated genetic variants in two genes (serotonin transporter, 5-HTT, and catechol-O-methyltransferase, COMT) that have been implicated in response to trauma. We collected buccal samples and survey data from 417 Syrian refugee and 306 Jordanian non-refugee youth who were enrolled in a randomized controlled trial to evaluate a mental health-focused intervention. Measures of lifetime trauma exposure, resilience, and six mental health and psychosocial stress outcomes were collected at three time points: baseline, ~13 weeks, and ~48 weeks. We used multilevel models to identify gene x environment (GxE) interactions and direct effects of the genetic variants in association with the six outcome measures over time. We did not identify any interactions with trauma exposure, but we did identify GxE interactions with both genes and resilience; 1) individuals with high expression (HE) variants of 5-HTTLPR and high levels of resilience had the lowest levels of perceived stress and 2) individuals homozygous for the Val variant of COMT with high levels of resilience showed stable levels of post-traumatic stress symptoms. We also identified a direct protective effect of 5-HTTLPR HE homozygotes on perceived insecurity. Our results point to novel interactions between the protective effects of genetic variants and resilience, lending support to ideas of differential susceptibility and altered stress reactivity in a cohort of war-affected adolescents.",2022,"We investigated genetic variants in two genes (serotonin transporter, 5-HTT, and catechol-O-methyltransferase, COMT) that have been implicated in response to trauma.","['417 Syrian refugee and 306 Jordanian non-refugee youth who were enrolled', 'psychosocial stress with war-affected youth']",['mental health-focused intervention'],"['lifetime trauma exposure, resilience, and six mental health and psychosocial stress outcomes', 'Novel GxE effects and resilience']","[{'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0018561', 'cui_str': 'Mesocricetus auratus'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0357629,"We investigated genetic variants in two genes (serotonin transporter, 5-HTT, and catechol-O-methyltransferase, COMT) that have been implicated in response to trauma.","[{'ForeName': 'Connie J', 'Initials': 'CJ', 'LastName': 'Mulligan', 'Affiliation': 'Department of Anthropology, University of Florida, Gainesville, Florida, United States of America.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Clukay', 'Affiliation': 'Department of Anthropology, University of Florida, Gainesville, Florida, United States of America.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Matarazzo', 'Affiliation': 'Department of Anthropology, University of Florida, Gainesville, Florida, United States of America.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Hadfield', 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Nevell', 'Affiliation': 'Department of Anthropology, University of Florida, Gainesville, Florida, United States of America.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Dajani', 'Affiliation': 'Department of Biology and Biotechnology, Faculty of Science, The Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Panter-Brick', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, Connecticut, United States of America.'}]",PloS one,['10.1371/journal.pone.0266509']
663,35384254,Impact of diabetes on clinical outcomes after revascularization with the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent and the sirolimus-eluting Orsiro stent.,"OBJECTIVES


To compare the efficacy and safety of the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (SES) in patients with and without diabetes mellitus (DM) included in the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X study.
BACKGROUND


The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with DM when compared to patients without DM. Thus, whether the results from the SORT OUT X study apply to patients with and without DM remains unknown.
METHODS


In total 3146 patients were randomized to stent implantation with DTS (n = 1578; DM: n = 279) or SES (n = 1568; DM: n = 271). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year.
RESULTS


At 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02-3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15-2.42). The differences were mainly explained by higher rates of TLR.
CONCLUSION


Compared to the SES, the DTS was associated with an increased risk of TLF at 12 months in patients with and without DM. The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without DM.",2022,"At 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02-3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15-2.42).","['patients with and without diabetes mellitus (DM', 'In total 3146 patients']","['sirolimus-eluting Orsiro stent (SES', 'TLF', 'stent implantation with DTS', 'SES', 'dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS']","['composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR', 'rates of cardiac death and target lesion MI', 'efficacy and safety', 'rate of TLF', 'risk of TLF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0054953', 'cui_str': 'Lymphocyte antigen CD34'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0001957', 'cui_str': 'Alcohol withdrawal delirium'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",3146.0,0.192899,"At 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02-3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15-2.42).","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Evald H', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Freeman', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Kahlert', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Veien', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Raungaard', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ellert', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Steen D', 'Initials': 'SD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Thim', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Eftekhari', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Rebekka V', 'Initials': 'RV', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nicolaj B', 'Initials': 'NB', 'LastName': 'Støttrup', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Junker', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Henrik S', 'Initials': 'HS', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Lisette O', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.30175']
664,35331007,Intensive Versus Standard Treatment of Hyperglycemia in Acute Ischemic Stroke Patient: A Randomized Clinical Trial Subgroups Analysis.,"BACKGROUND


Benefit from blood glucose (BG) control during acute ischemic stroke may depend on glycemic parameters. We evaluated for associations between the SHINE (Stroke Hyperglycemia Insulin Network Effort) randomized treatment group and the SHINE predefined 90-day functional outcome, within-patient subgroups defined by various glycemic parameters.
METHODS


The SHINE Trial randomized 1151 patients within 12 hours with acute ischemic stroke and hyperglycemia to standard (target BG 80-179 mg/dL) or intensive (target BG 80-130 mg/dL) BG control for 72 hours. We predefined 6 glycemic parameters: acute BG level, absence versus presence of diagnosed and undiagnosed diabetes, hemoglobin A1c, glycemic gap (acute BG-average daily hemoglobin A1c based BG), stress hyperglycemia ratio (acute BG/average daily hemoglobin A1c based BG), and BG variability (SD). Favorable functional outcome was defined by the SHINE Trial and based on the modified Rankin Scale score at 90 days, adjusted for stroke severity. We computed relative risks adjusted for baseline stroke severity and thrombolysis use.
RESULTS


Likelihood for favorable outcome was lowest among patients with undiagnosed diabetes compared to patients with true nondiabetes (adjusted relative risk, 0.42 [99% CI, 0.19-0.94]). We did not find any relationship between the favorable outcome rate and baseline BG or any of the glycemic parameters. No differences between SHINE treatment groups were identified among any of these patient subgroups.
CONCLUSIONS


In this exploratory subgroup analysis, intensive versus standard insulin treatment of hyperglycemia in acute ischemic stroke patient subgroups, did not influence the 90-day functional outcomes, nor did we identify associations between these glycemic parameters and 90-day functional outcomes.",2022,"No differences between SHINE treatment groups were identified among any of these patient subgroups.
","['1151 patients within 12 hours with acute ischemic stroke and hyperglycemia to standard (target BG 80-179 mg/dL) or intensive (target BG 80-130 mg/dL) BG control for 72 hours', 'Acute Ischemic Stroke Patient', 'acute ischemic stroke patient subgroups']","['blood glucose (BG) control', 'Intensive Versus Standard Treatment of Hyperglycemia']","['glycemic parameters: acute BG level, absence versus presence of diagnosed and undiagnosed diabetes, hemoglobin A1c, glycemic gap (acute BG-average daily hemoglobin A1c based BG), stress hyperglycemia ratio (acute BG/average daily hemoglobin A1c based BG), and BG variability (SD', 'modified Rankin Scale score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292423', 'cui_str': '72 hours'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0342303', 'cui_str': 'Metabolic stress hyperglycemia'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1151.0,0.0594662,"No differences between SHINE treatment groups were identified among any of these patient subgroups.
","[{'ForeName': 'Michel T', 'Initials': 'MT', 'LastName': 'Torbey', 'Affiliation': 'Department of Neurology, University of New Mexico, Albuquerque (M.T.T.).'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pauls', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Q.P., V.L.D.).'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gentile', 'Affiliation': 'Department of Emergency Medicine, Temple University, Philadelphia, PA (N.G.).'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Falciglia', 'Affiliation': 'Department of Internal Medicine and Cincinnati VAMC, University of Cincinnati College of Medicine, OH (M.F.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Meurer', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor (W.M.).'}, {'ForeName': 'Creed L', 'Initials': 'CL', 'LastName': 'Pettigrew', 'Affiliation': 'Department of Neurology, University of Kentucky, Lexington (C.L.P.).'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Durkalski', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Q.P., V.L.D.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bleck', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL (T.B.).'}, {'ForeName': 'Askiel', 'Initials': 'A', 'LastName': 'Bruno', 'Affiliation': 'Department of Neurology, Augusta University, GA (A.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.033048']
665,35332654,Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease.,"AIM


To evaluate the cardiovascular (CV) efficacy of liraglutide and semaglutide in patients with type 2 diabetes (T2D) and peripheral artery disease (PAD).
MATERIALS AND METHODS


LEADER and SUSTAIN 6 trials investigated subcutaneous liraglutide (≤1.8 mg/day) and semaglutide (0.5 or 1.0 mg/week), respectively, versus placebo in patients with T2D and high CV risk (median follow-up: 3.8 and 2.1 years, respectively). The primary outcome was a composite of CV death, non-fatal myocardial infarction or non-fatal stroke (major adverse CV event [MACE]) according to the presence of PAD at baseline.
RESULTS


Overall, 1184/9340 (12.7%) patients in LEADER and 460/3297 (14.0%) in SUSTAIN 6 had PAD at baseline. Patients with PAD were at an ~35% increased risk of MACE versus those without (LEADER: hazard ratio [HR] 1.36, 95% confidence interval [CI] 1.17-1.58; SUSTAIN 6: HR 1.33, 95% CI 0.94-1.83). The effects of both therapies on MACE were consistently beneficial in patients with PAD (liraglutide: HR 0.77, 95% CI 0.58-1.01; semaglutide: 0.61, 0.33-1.13) and without (liraglutide: HR 0.89, 95% CI 0.79-1.00; semaglutide: HR 0.77, 95% CI 0.58-1.01; P interaction   = .34 for liraglutide and .49 for semaglutide). Absolute risk reductions for MACE were higher in patients with PAD (liraglutide: 4.13%-point, 95% CI -0.15-8.42; semaglutide: 4.63%-point, 95% CI -0.58-9.84) versus without (liraglutide:1.42%-point, 95% CI -0.03-2.87; semaglutide: 1.90%-point, 95% CI 0.00-3.80).
CONCLUSION


Both liraglutide and semaglutide reduce MACE with consistent CV efficacy regardless of PAD status.",2022,"Absolute risk reductions for MACE were higher in patients with PAD (liraglutide: 4.13 %-point, 95% CI -0.15-8.42; semaglutide: 4.63 %-point, 95% CI -0.58-9.84) vs without (liraglutide:1.42 %-point,","['patients with T2D and high CV risk (median follow-up: 3.8 and 2.1\u2009years, respectively', 'Patients with peripheral artery disease (PAD) and type 2 diabetes (T2D', 'patients with T2D and PAD', 'individuals with diabetes and peripheral artery disease']","['placebo', 'subcutaneous liraglutide', 'liraglutide and semaglutide', 'MACE', 'liraglutide']","['Cardiovascular efficacy', 'CV efficacy', 'risk of MACE', 'Absolute risk reductions for MACE', 'composite of CV death, nonfatal myocardial infarction or nonfatal stroke (major adverse CV event [MACE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.269552,"Absolute risk reductions for MACE were higher in patients with PAD (liraglutide: 4.13 %-point, 95% CI -0.15-8.42; semaglutide: 4.63 %-point, 95% CI -0.58-9.84) vs without (liraglutide:1.42 %-point,","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Omran', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sejersten Ripa', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'CPC Clinical Research, University of Colorado School of Medicine, Aurora, Colorado, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14700']
666,35340008,Therapeutic Touch in the Management of Responsive Behaviors in Patients with Dementia.,"INTRODUCTION


This study aimed to investigate the use of therapeutic touch (TT) in the management of responsive behaviors in patients with dementia.
METHODS


A randomized, double-blinded control trial was used to compare response to TT in a population with responsive behaviors in dementia, in 3 phases, pretreatment, treatment, and posttreatment each lasting 5 days. The participants were divided into three groups: experimental, placebo, and control. The experimental group received regular TT, the placebo group received mimic TT, and the control group received regular routine care. Behavior was observed and recorded by trained research assistants every 20 min during the study time throughout each of the phases. Modified Agitated Behavior Rating Scale (ABRS) and Revised Memory and Behavior Check (RMBC) scores were used to assess the behavioral symptoms of dementia throughout the study.
RESULTS


All groups had decreasing RMBC scores during the pretreatment period, however; the experimental TT group was the only group whose RMBC scores continued to decrease during the treatment period. All groups had a similar pattern of rates of change in ABRS scores over the 15-day period, with no differential pattern of results related to experimental TT.
CONCLUSION


Despite limited evidence, TT should be explored as an adjunctive therapy for reducing behavioral symptoms in individuals with dementia. Further research is needed to determine the effects of TT on responsive behaviors in dementia. There is a need for studies with larger sample sizes, equal distribution of participants between groups (in terms of dementia stages), and longer post study follow-ups.",2022,"All groups had decreasing RMBC scores during the pretreatment period, however; the experimental TT group was the only group whose RMBC scores continued to decrease during the treatment period.","['individuals with dementia', 'patients with dementia', 'population with responsive behaviors in dementia, in 3 phases, pretreatment, treatment, and posttreatment each lasting 5 days', 'Patients with Dementia']","['TT', 'placebo, and control', 'therapeutic touch (TT', 'regular TT, the placebo group received mimic TT, and the control group received regular routine care']","['Behavior', 'RMBC scores', 'behavioral symptoms', 'Modified Agitated Behavior Rating Scale (ABRS) and Revised Memory and Behavior Check (RMBC) scores', 'ABRS scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439561', 'cui_str': 'Phase 3'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0351383,"All groups had decreasing RMBC scores during the pretreatment period, however; the experimental TT group was the only group whose RMBC scores continued to decrease during the treatment period.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Senderovich', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gardner', 'Affiliation': 'Baycrest Kunin-Lunenfeld Centre for Applied Research and Evaluation (KL-CARE), Toronto, Ontario, Canada.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Berall', 'Affiliation': 'Baycrest Kunin-Lunenfeld Centre for Applied Research and Evaluation (KL-CARE), Toronto, Ontario, Canada.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Shultz', 'Affiliation': 'Baycrest SageCare, Toronto, Ontario, Canada.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Grant', 'Affiliation': 'Baycrest SageCare, Toronto, Ontario, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Santaguida', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}]",Dementia and geriatric cognitive disorders,['10.1159/000523752']
667,35339954,"Effects of an individualized and progressive multicomponent exercise program on blood pressure, cardiorespiratory fitness, and body composition in long-term care residents: Randomized controlled trial.","This study analyzed the effects of an individualized and progressive multicomponent exercise program on blood pressure, cardiorespiratory fitness, and body composition in long-term care residents. This was a single-blind, multicenter, randomized controlled trial performed in 10 long-term care settings and involved 112 participants. Participants were randomly assigned to a control group or an intervention group. The control group participated in routine activities; the intervention group participated in a six-month individualized and progressive multicomponent exercise program focused on strength, balance, and walking recommendations. The intervention group maintained peak VO 2 , oxygen saturation, and resting heart rate, while the control group showed a significant decrease in peak VO 2  and oxygen saturation and an increase in resting heart rate throughout the six-month period. Individualized and progressive multicomponent exercise programs comprising strength, balance, and walking recommendations appear to be effective in preventing cardiorespiratory fitness decline in older adults living in long-term care settings.",2022,"The intervention group maintained peak VO 2 , oxygen saturation, and resting heart rate, while the control group showed a significant decrease in peak VO 2  and oxygen saturation and an increase in resting heart rate throughout the six-month period.","['older adults living in long-term care settings', '10 long-term care settings and involved 112 participants', 'long-term care residents']","['individualized and progressive multicomponent exercise program', 'routine activities; the intervention group participated in a six-month individualized and progressive multicomponent exercise program focused on strength, balance, and walking recommendations']","['blood pressure, cardiorespiratory fitness, and body composition', 'peak VO 2  and oxygen saturation', 'peak VO 2 , oxygen saturation, and resting heart rate', 'resting heart rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}]",112.0,0.00860266,"The intervention group maintained peak VO 2 , oxygen saturation, and resting heart rate, while the control group showed a significant decrease in peak VO 2  and oxygen saturation and an increase in resting heart rate throughout the six-month period.","[{'ForeName': 'Haritz', 'Initials': 'H', 'LastName': 'Arrieta', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Begiristain Doktorea Pasealekua 105, E-20014 Donostia-San Sebastián, Gipuzkoa, Spain.. Electronic address: haritz.arrieta@ehu.eus.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Rezola-Pardo', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa, Bizkaia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gil', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa, Bizkaia, Spain.'}, {'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Kortajarena', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Begiristain Doktorea Pasealekua 105, E-20014 Donostia-San Sebastián, Gipuzkoa, Spain.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Zarrazquin', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Begiristain Doktorea Pasealekua 105, E-20014 Donostia-San Sebastián, Gipuzkoa, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Echeverria', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa, Bizkaia, Spain.; Department of Physical Education and Sport, Faculty of Education and Sport, University of the Basque Country (UPV/EHU), Portal de Lasarte 71, E-01007 Vitoria-Gasteiz (Araba), Spain.'}, {'ForeName': 'Itxaso', 'Initials': 'I', 'LastName': 'Mugica', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Begiristain Doktorea Pasealekua 105, E-20014 Donostia-San Sebastián, Gipuzkoa, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Limousin', 'Affiliation': 'Uzturre Asistentzia Gunea, San Joan Kalea 4, E-20400 Tolosa (Gipuzkoa), Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Larrad', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa, Bizkaia, Spain.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa, Bizkaia, Spain.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.03.005']
668,35346603,Efficacy and safety of bempedoic acid in patients not receiving statins in phase 3 clinical trials.,"BACKGROUND


Despite the high incidence of patients with statin tolerance problems, randomized evaluations of nonstatin oral treatment options for lowering of low-density lipoprotein cholesterol (LDL-C) in this population are sparse.
OBJECTIVE


To assess the LDL-C lowering effect of bempedoic acid in patients not taking statins.
METHODS


This was a pooled analysis of data from patients enrolled in four phase 3 bempedoic acid studies (12 to 52 weeks in duration) who were not taking concomitant statins (Phase 3 No Statin Cohort) and a phase 3 bempedoic acid plus ezetimibe fixed-dose combination study (BA+EZE FDC No Statin Cohort). The primary endpoint for all studies was the percent change from baseline to week 12 in LDL-C levels. Safety and tolerability were assessed by laboratory values and adverse events.
RESULTS


In the Phase 3 No Statin Cohort, bempedoic acid (n = 394) lowered LDL-C levels at week 12 significantly more than placebo (n = 192; -26.5% [95% CI, -29.7%, -23.2%]; P<0.001). The fixed-dose combination of bempedoic acid with ezetimibe lowered LDL-C by 39.2% (95% CI, -51.7% to -26.7%; P<0.001). Muscle-related disorders occurred at a rate of 26.4 and 28.6 per 100 person-years with bempedoic acid and placebo, respectively.
CONCLUSIONS


In patients with hypercholesterolemia unable to take statins, bempedoic acid lowered LDL-C levels by a mean of 26.5% vs placebo and bempedoic acid + ezetimibe fixed-dose combination lowered LDL-C by 39.2%. The treatments were generally well tolerated, suggesting that bempedoic acid may be efficacious and well tolerated in this challenging-to-treat patient population.",2022,"Muscle-related disorders occurred at a rate of 26.4 and 28.6 per 100 person-years with bempedoic acid and placebo, respectively.
","['patients not receiving statins in phase 3 clinical trials', 'patients with hypercholesterolemia', 'patients with statin tolerance problems', 'patients enrolled in four phase 3 bempedoic acid studies (12 to 52 weeks in duration) who were not taking concomitant statins (Phase 3 No Statin Cohort) and a phase 3 bempedoic acid plus ezetimibe fixed-dose combination study (BA+EZE FDC No Statin Cohort', 'patients not taking statins']","['bempedoic acid', 'placebo', 'bempedoic acid with ezetimibe']","['Muscle-related disorders', 'low-density lipoprotein cholesterol (LDL-C', 'LDL-C', 'laboratory values and adverse events', 'LDL-C levels', 'Efficacy and safety', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}]","[{'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.164922,"Muscle-related disorders occurred at a rate of 26.4 and 28.6 per 100 person-years with bempedoic acid and placebo, respectively.
","[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Germany. Electronic address: ulrich.laufs@medizin.uni-leipzig.de.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA. Electronic address: cmb@bcm.edu.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Preventive Cardiology and Lipidology, Medical University of Łódź, Łódź Poland and Cardiovascular Research Centre, University of Zielona Gora, Zielona Gora, Poland. Electronic address: maciej.banach@icloud.com.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA. Electronic address: hbaysmd@outlook.com.'}, {'ForeName': 'Alberico L', 'Initials': 'AL', 'LastName': 'Catapano', 'Affiliation': 'Department of Pharmacological and Biomolecular Sciences, University of Milan and IRCCS Multimedica, Milan, Italy. Electronic address: alberico.catapano@unimi.it.'}, {'ForeName': 'P Barton', 'Initials': 'PB', 'LastName': 'Duell', 'Affiliation': 'Knight Cardiovascular Institute, School of Medicine, Oregon Health & Science University, Portland, Oregon, USA. Electronic address: duellb@ohsu.edu.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA. Electronic address: agoldber@wustl.edu.'}, {'ForeName': 'Antonio M', 'Initials': 'AM', 'LastName': 'Gotto', 'Affiliation': 'Cardiovascular Unit, Weill Cornell Medical College, New York, New York, USA. Electronic address: amg2004@med.cornell.edu.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. Electronic address: lawrence.leiter@unityhealth.to.""}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Department of Primary Care and Public Health, Imperial College London, London, UK. Electronic address: k.ray@imperial.ac.uk.'}, {'ForeName': 'LeAnne T', 'Initials': 'LT', 'LastName': 'Bloedon', 'Affiliation': 'Esperion Therapeutics, Inc., Ann Arbor, Michigan, USA. Electronic address: lbloedon@esperion.com.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'MacDougall', 'Affiliation': 'Esperion Therapeutics, Inc., Ann Arbor, Michigan, USA. Electronic address: dmacdougall@esperion.com.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Esperion Therapeutics, Inc., Ann Arbor, Michigan, USA. Electronic address: yazhang@esperion.com.'}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': 'Department of Medicine, Division of Cardiology, Centre for Cardiovascular Innovation, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: mancini@mail.ubc.ca.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2022.03.001']
669,35351835,The Potential Role for Impaired Mucosal Integrity in the Generation of Esophageal Pain Using Capsaicin in Humans: An Explorative Study.,"INTRODUCTION


Esophageal pain is mediated by sensory nerves, most importantly by the activation of the transient receptor potential vanilloid 1 (TRPV1) capsaicin receptor. TRPV1 is activated and sensitized by a broad range of pungent compounds, as well as inflammatory mediators and tissue irritants. Luminal stressors are suggested to impair the barrier function, which results in consequent activation of these sensory nerve terminals and pain. In this study, we investigated the effect of the perfusion of capsaicin, a TRPV1 agonist, on mucosal impedance and pain in asymptomatic volunteers.
METHODS


Thirteen asymptomatic volunteers completed a single-blind, saline-controlled, randomized crossover study. Capsaicin or saline was perfused for 30 minutes in the distal esophagus. Visual analog scale pain intensity scores and intraluminal impedance indicating mucosal integrity were determined. Distal and proximal biopsies were obtained 10 minutes later to measure TRPV1 messenger RNA and TRPV1 immunopositivity, as well as the intercellular space area.
RESULTS


Capsaicin perfusion resulted in significantly greater pain intensity (P = 0.047) and impaired recovery of the mucosal impedance compared with saline-treated controls (P = 0.027). Pain response was significantly associated with decreased mucosal impedance. Similar dynamics were seen in the proximal esophagus, but mucosal impedance recovered entirely to the preinfusion values there. There was a significant association between mucosal impedance and intercellular space width in the distal esophagus. TRPV1 transcription and expression were not significantly altered within this observation period.
DISCUSSION


Esophageal capsaicin perfusion results in pain, which is likely to be explained by impaired mucosal impedance and defective restoration capacity in the distal esophagus.",2022,"RESULTS


Capsaicin perfusion resulted in significantly greater pain intensity (P=0.047) and impaired recovery of the mucosal impedance compared to saline-treated controls (P=0.027).","['Thirteen asymptomatic volunteers', 'humans', 'asymptomatic volunteers']","['capsaicin', 'Capsaicin or saline', 'capsaicin, a TRPV1 agonist']","['pain intensity', 'Pain response', 'Visual Analogue Scale (VAS) pain intensity scores and intraluminal impedance indicating mucosal integrity', 'mucosal impedance and pain', 'recovery of the mucosal impedance', 'TRPV1 transcription and expression', 'mucosal impedance', 'mucosal impedance and intercellular space width']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0015352', 'cui_str': 'Extracellular space'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",13.0,0.0487021,"RESULTS


Capsaicin perfusion resulted in significantly greater pain intensity (P=0.047) and impaired recovery of the mucosal impedance compared to saline-treated controls (P=0.027).","[{'ForeName': 'Annick M E', 'Initials': 'AME', 'LastName': 'Alleleyn', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Keszthelyi', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Nicolaas F', 'Initials': 'NF', 'LastName': 'Rinsma', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Csekő', 'Affiliation': 'Department of Pharmacology and Pharmacotherapy, Medical School, Janos Szentagothai Research Centre & Centre for Neuroscience, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Kajtár', 'Affiliation': 'Department of Pathology, Medical School, Clinical Centre, University of Pécs, Pécs, Hungary; and.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Helyes', 'Affiliation': 'Department of Pharmacology and Pharmacotherapy, Medical School, Janos Szentagothai Research Centre & Centre for Neuroscience, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Adrian A M', 'Initials': 'AAM', 'LastName': 'Masclee', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Conchillo', 'Affiliation': 'Division of Gastroenterology-Hepatology, Department of Internal Medicine, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000488']
670,35357449,Comparative Effectiveness of Immune Checkpoint Inhibitors vs Chemotherapy by Tumor Mutational Burden in Metastatic Castration-Resistant Prostate Cancer.,"Importance


The most useful biomarkers for clinical decision-making identify patients likely to have improved outcomes with one treatment vs another.
Objective


To evaluate treatment class-specific outcomes of patients receiving immune checkpoint inhibitor (ICI) vs taxane chemotherapy by tumor mutational burden (TMB).
Design, Setting, and Participants


This comparative effectiveness analysis of clinical variables and outcomes used prospectively defined biomarker-stratified genomic data from a deidentified clinicogenomic database. Data included men with previously treated metastatic castration-resistant prostate cancer (mCRPC) receiving ICI or single-agent taxane chemotherapy from January 2011 to April 2021 at approximately 280 US academic or community-based cancer clinics (approximately 800 sites of care). Data were analyzed from July to August 2021.
Exposures


Single-agent ICI or single-agent taxanes. Treatments were assigned at discretion of physician and patient without randomization. Imbalances of known factors between treatment groups were adjusted with propensity weighting.
Main Outcomes and Measures


Prostate-specific antigen (PSA) response, time to next therapy (TTNT), and overall survival (OS).
Results


A total of 741 men (median [IQR], 70 [64-76] years) with mCRPC received comprehensive genomic profiling and were treated with ICI or single-agent taxane therapy. At baseline, the median (IQR) PSA level was 79.4 (19.0-254) ng/mL, 108 men (18.8%) had Eastern Cooperative Oncology Group Performance Status scores of 2 or greater, and 644 men (86.9%) had received prior systemic treatments for mCRPC. A total of 45 patients (6.1%) received ICI therapy and 696 patients (93.9%) received taxane therapy. Among patients with TMB of fewer than 10 mutations per megabase (mt/Mb) receiving ICI, compared with those receiving taxanes, had worse TTNT (median [IQR], 2.4 [1.1-3.2] months vs 4.1 [2.2-6.3] months; hazard ratio [HR], 2.65; 95% CI, 1.78-3.95; P < .001). In contrast, for patients with TMB of 10 mt/Mb or greater, use of ICIs, compared with use taxanes, was associated with more favorable TTNT (median [IQR], 8.0 [3.4 to unknown] months vs 2.4 [2.4-7.3] months; HR, 0.37, 95% CI, 0.15-0.87; P = .02) and OS (median 19.9 [8.06 to unknown] months vs 4.2 [2.69 - 6.12] months; HR, 0.23; 95% CI, 0.10-0.57; P = .001). Among all 741 patients, 44 (5.9%) had TMB of 10 mt/Mb or greater, 22 (3.0%) had high microsatellite instability, and 20 (2.7%) had both. Treatment interactions with TMB of 10 mt/Mb or greater (TTNT: HR, 0.10; 95% CI, 0.32-0.31; P < .001; OS: HR, 0.25; 95% CI, 0.076-0.81; P = .02) were stronger than high microsatellite instability alone (TTNT: HR, 0.12; 95% CI, 0.03-0.51; P = .004; OS: HR, 0.38; 95% CI, 0.13-1.12; P = .08).
Conclusions and Relevance


In this comparative effectiveness study, ICIs were more effective than taxanes in patients with mCRPC when TMB was 10 mt/Mb or greater but not when TMB was fewer than 10 mt/Mb. The results add validity to the existing TMB cutoff of 10 mt/Mb for ICI use in later lines of therapy, and suggest that ICIs may be a viable alternative to taxane chemotherapy for patients with mCRPC with high TMB.",2022,"; OS: HR, 0.25; 95% CI, 0.076-0.81; P = .02) were stronger than high microsatellite instability alone (TTNT: HR, 0.12; 95% CI, 0.03-0.51; P = .004; OS: HR, 0.38; 95% CI, 0.13-1.12; P = .08).
","['patients with mCRPC with high TMB', 'men with previously treated metastatic castration-resistant prostate cancer (mCRPC) receiving ICI or single-agent taxane chemotherapy from January 2011 to April 2021 at approximately 280 US academic or community-based cancer clinics (approximately 800 sites of care', 'patients receiving', 'Metastatic Castration-Resistant Prostate Cancer', '741 men (median [IQR], 70 [64-76] years) with mCRPC received comprehensive genomic profiling and were treated with']","['ICI therapy', 'taxane chemotherapy', 'immune checkpoint inhibitor (ICI) vs taxane chemotherapy', 'Immune Checkpoint Inhibitors vs Chemotherapy', 'Exposures\n\n\nSingle-agent ICI or single-agent taxanes', 'taxanes', 'taxane therapy', 'ICI or single-agent taxane therapy']","['OS', 'Measures\n\n\nProstate-specific antigen (PSA) response, time to next therapy (TTNT), and overall survival (OS', 'TMB', 'median (IQR) PSA level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",45.0,0.150771,"; OS: HR, 0.25; 95% CI, 0.076-0.81; P = .02) were stronger than high microsatellite instability alone (TTNT: HR, 0.12; 95% CI, 0.03-0.51; P = .004; OS: HR, 0.38; 95% CI, 0.13-1.12; P = .08).
","[{'ForeName': 'Ryon P', 'Initials': 'RP', 'LastName': 'Graf', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Fisher', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Janick', 'Initials': 'J', 'LastName': 'Weberpals', 'Affiliation': 'Real World Data Collaborations, Personalized Healthcare Data, Analytics and Imaging, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Gjoerup', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Marni B', 'Initials': 'MB', 'LastName': 'Tierno', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Richard S P', 'Initials': 'RSP', 'LastName': 'Huang', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sayegh', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City.'}, {'ForeName': 'Douglas I', 'Initials': 'DI', 'LastName': 'Lin', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Raskina', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Alexa B', 'Initials': 'AB', 'LastName': 'Schrock', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Severson', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Haberberger', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Ross', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Creeden', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Mia A', 'Initials': 'MA', 'LastName': 'Levy', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Alexander', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Geoffrey R', 'Initials': 'GR', 'LastName': 'Oxnard', 'Affiliation': 'Foundation Medicine, Cambridge, Massachusetts.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.5394']
671,34870587,Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study.,"STUDY OBJECTIVES


The clinical benefits of positive airway pressure (PAP) therapy for obstructive sleep apnea are assumed to require adherent PAP usage, defined by the Centers for Medicare & Medicaid Services as ≥ 4 hours of use ≥ 70% of nights. However, this definition is based on early data and does not necessarily capture improvements at subthreshold adherence. We explored dose-response relationships between PAP adherence measures and excessive daytime sleepiness from the HomePAP randomized controlled trial.
METHODS


Participants aged ≥ 18 years with an apnea-hypopnea index ≥ 15 events/h and baseline sleepiness (Epworth Sleepiness Scale [ESS] ≥ 12) received PAP therapy. Data were collected at baseline, 1-month follow-up, and 3-months follow-up. Regression models and receiver operating characteristic curves evaluated PAP measures as predictors of ESS change and normalization (ESS < 10).
RESULTS


In 119 participants (aged 49.4 ± 12.6 years, 66.4% male, 72.3% White), > 50% were PAP nonadherent per Centers for Medicare & Medicaid Services criteria at 3 months. The percentage of nights with PAP use ≥ 4 hours predicted ESS change ( P  = .023), but not when controlling for the apnea-hypopnea index. The percentage of nights with ≥ 4 hours and average PAP use provided the best discrimination for predicting ESS normalization; each 10% increase in PAP use ≥ 4 hours increased the odds of ESS normalization by 22% ( P  = .007); those using PAP ≥ 4 hours had a nearly 3-fold greater odds of ESS normalization ( P  = .025). PAP use for at least 4 hours and on 70% of nights provided the best balance between specificity (0.50) and sensitivity (0.73).
CONCLUSIONS


Although subadherent PAP usage may still confer some benefit for patients with obstructive sleep apnea, adherence to current criteria confers the highest likelihood for ESS change and normalization.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP); URL: https://clinicaltrials.gov/ct2/show/NCT00642486; Identifier: NCT00642486.
CITATION


Pascoe M, Bena J, Andrews ND, et al. Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study.  J Clin Sleep Med.  2022;18(4):1027-1034.",2022,"The percentage of nights with PAP use ≥ 4 hours predicted ESS change ( P  = .023), but not when controlling for the apnea-hypopnea index.","['obstructive sleep apnea', '119 participants (aged 49.4\u2009±\u200912.6 years, 66.4% male, 72.3% White), > 50% were PAP nonadherent per Centers for Medicare & Medicaid Services criteria at 3 months', 'patients with obstructive sleep apnea', 'Participants aged ≥ 18 years with an apnea-hypopnea index ≥ 15 events/h and baseline sleepiness (Epworth Sleepiness Scale [ESS] ≥ 12) received']","['positive airway pressure therapy', 'positive airway pressure (PAP) therapy', 'PAP therapy']","['excessive daytime sleepiness', 'percentage of nights with PAP use ≥ 4 hours predicted ESS change', 'ESS normalization', 'percentage of nights with ≥ 4 hours and average PAP', 'apnea-hypopnea index']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",,0.0784099,"The percentage of nights with PAP use ≥ 4 hours predicted ESS change ( P  = .023), but not when controlling for the apnea-hypopnea index.","[{'ForeName': 'Maeve', 'Initials': 'M', 'LastName': 'Pascoe', 'Affiliation': 'Cleveland Clinic Sleep Disorders Center, Cleveland, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bena', 'Affiliation': 'Cleveland Clinic Sleep Disorders Center, Cleveland, Ohio.'}, {'ForeName': 'Noah D', 'Initials': 'ND', 'LastName': 'Andrews', 'Affiliation': 'Cleveland Clinic Sleep Disorders Center, Cleveland, Ohio.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Auckley', 'Affiliation': 'MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland Ohio.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Benca', 'Affiliation': 'University of California, Irvine, Irvine, California.'}, {'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Billings', 'Affiliation': 'Harborview Medical Center, University of Washington, Seattle, Washington.'}, {'ForeName': 'Vishesh K', 'Initials': 'VK', 'LastName': 'Kapur', 'Affiliation': 'Harborview Medical Center, University of Washington, Seattle, Washington.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Iber', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Brigham and Women's Hospital and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Rosen', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Foldvary-Schaefer', 'Affiliation': 'Cleveland Clinic Sleep Disorders Center, Cleveland, Ohio.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9792']
672,35364115,Segments of military ration pack eaters: Choice preferences among groups.,"Best-Worst Scaling (BWS) has the potential to improve menu design by determining the most and least preferred combat ration pack (CRP) items by military personnel. However, individual differences among large groups means that a ration pack design based on the average of preferences may leave many individuals dissatisfied. This paper extends the existing literature by segmenting Australian military personnel based on the preferences for specific ration pack items. Military personnel (n = 300) provided BWS data via an online survey providing product preferences for 21 items. Participants were randomly allocated to one of four different military scenarios developed and refined by Australian Defence Force (ADF) personnel, ensuring consistency with typical operational and training exercises. The four scenarios were presented with two environment variations (hot/dry or hot/humid) and two resupply variations (daily or resupply on day four and day seven) creating four survey sub-groups. Two-step cluster analysis revealed three military segments (Snackers, Balanced eaters, and Mindful eaters) with distinct CRP item preferences across the larger military group. This study provides insights of the feasibility and usefulness of segmenting military personnel based on ration pack item preferences. This approach could streamline the process for decision makers responsible for designing and developing ration packs, and ultimately increase consumption so that personnel obtain essential nutrition to support their performance.",2022,"Two-step cluster analysis revealed three military segments (Snackers, Balanced eaters, and Mindful eaters) with distinct CRP item preferences across the larger military group.",[],"['military scenarios developed and refined by Australian Defence Force (ADF) personnel, ensuring consistency with typical operational and training exercises']",[],[],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0548278,"Two-step cluster analysis revealed three military segments (Snackers, Balanced eaters, and Mindful eaters) with distinct CRP item preferences across the larger military group.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kitunen', 'Affiliation': 'Social Marketing @ Griffith, Griffith University, 170 Kessels Road, Nathan, QLD, 4111, Australia. Electronic address: a.kitunen@griffith.ed.au.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Carins', 'Affiliation': 'Social Marketing @ Griffith, Griffith University, 170 Kessels Road, Nathan, QLD, 4111, Australia. Electronic address: j.carins@griffith.edu.au.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'De Diana', 'Affiliation': 'Food and Nutrition, Land Division, Defence Science and Technology, Scottsdale, TAS, 7260, Australia. Electronic address: jeanine.dediana2@dst.defence.gov.au.'}]",Appetite,['10.1016/j.appet.2022.106023']
673,35364479,Effects of fundamental movement skills based dual-task and dance training on single- and dual-task walking performance in older women with dementia.,"OBJECTIVE


The purpose of this study was to compare the effects of fundamental movement skills (FMS)-based dual-task training and dance training on spatio-temporal characteristics of gait performance under single- and dual-task walking conditions among older women with dementia.
METHOD


Thirty-eight elderly females with dementia were randomly assigned to one of two groups: (1) dual-task intervention (DTI, age: 73 ± 6.5 years) or (2) Iranian dance intervention (IDI, age: 72.52 ± 6.01 years). Both groups participated in a 10-week intervention program (3 sessions per week, each lasting 50 min). Gait performance parameters (gait speed, cadence, and stride length) and dual-task costs (DTC) were examined using a gait analysis system. The participants completed three walking trials under two conditions: single- and dual-task. The video data was analyzed using motion analysis software (Frame-DIAS II, DKH, DKH Inc., Tokyo, Japan).
RESULTS


The results showed that both groups significantly improved in terms of all gait variables, and DTC decreased (p < .001) from pre- to post-test for both conditions. However, the main effects for the group and the group-by-time interactions were not significantly different between the two groups (p > .05).
CONCLUSION


These findings showed that DTI and IDI effectively improved gait performance following a 10-week intervention for older women with dementia. Therefore, it is suggested that either training program could decrease DTC and increase gait speed, stride length, and cadence among older females with dementia.",2022,These findings showed that DTI and IDI effectively improved gait performance following a 10-week intervention for older women with dementia.,"['Thirty-eight elderly females with dementia', 'older women with dementia', 'older females with dementia']","['single- and dual-task walking conditions', 'fundamental movement skills (FMS)-based dual-task training and dance training', 'fundamental movement skills based dual-task and dance training', 'dual-task intervention (DTI, age: 73\xa0±\xa06.5 years) or (2) Iranian dance intervention']","['Gait performance parameters (gait speed, cadence, and stride length) and dual-task costs (DTC', 'gait performance', 'DTC and increase gait speed, stride length, and cadence', 'all gait variables, and DTC', 'single- and dual-task walking performance']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]",38.0,0.0170218,These findings showed that DTI and IDI effectively improved gait performance following a 10-week intervention for older women with dementia.,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ghadiri', 'Affiliation': 'Department of Motor behavior, Faculty of Physical Education and Sport Sciences, Kharazmi University, Tehran, Iran. Electronic address: ghadiri@khu.ac.ir.'}, {'ForeName': 'Moslem', 'Initials': 'M', 'LastName': 'Bahmani', 'Affiliation': 'Department of Motor behavior, Faculty of Physical Education and Sport Sciences, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Paulson', 'Affiliation': 'St. Elizabeth Healthcare, Edgewood, KY, USA.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Biomechanics and Sport Injuries, Faculty of Physical Education and Sport Sciences, Kharazmi University, Tehran, Iran.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.03.003']
674,35388512,A general practice intervention for people at risk of poor health outcomes: the Flinders QUEST cluster randomised controlled trial and economic evaluation.,"OBJECTIVE


To determine whether a multicomponent general practice intervention cost-effectively improves health outcomes and reduces health service use for patients at high risk of poor health outcomes.
DESIGN, SETTING


Clustered randomised controlled trial in general practices in metropolitan Adelaide.
PARTICIPANTS


Three age-based groups of patients identified by their general practitioners as being at high risk of poor health outcomes: children and young people (under 18 years), adults (18-64 years) with two or more chronic diseases, and older people (65 years or more).
INTERVENTION


Enrolment of patients with a preferred GP, longer general practice appointments, and general practice follow-up within seven days of emergency department and hospital care episodes. Intervention practices received payment of $1000 per enrolled participant.
MAIN OUTCOME MEASURES


Primary outcome: change in self-rated health between baseline and 12-month follow-up for control (usual care) and intervention groups.
SECONDARY OUTCOMES


numbers of emergency department presentations and hospital admissions, Medicare specialist claims and Pharmaceutical Benefits Scheme (PBS) items supplied, Health Literacy Questionnaire scores, and cost-effectiveness of the intervention (based on the number of quality-adjusted life-years [QALYs] gained over 12 months, derived from EQ-5D-5L utility scores for the two adult groups).
RESULTS


Twenty practices with a total of 92 GPs were recruited, and 1044 eligible patients participated. The intervention did not improve self-rated health (coefficient, -0.29; 95% CI, -2.32 to 1.73), nor did it have significant effects on the numbers of emergency department presentations (incidence rate ratio [IRR], 0.90; 95% CI, 0.69-1.17), hospital admissions (IRR, 0.90; 95% CI, 0.66-1.22), Medicare specialist claims (IRR, 1.00; 95% CI, 0.91-1.09), or PBS items supplied (IRR, 0.99; 95% CI, 0.96-1.03), nor on Health Literacy Questionnaire scores. The intervention was effective in terms of QALYs gained (v usual care: difference, 0.032 QALYs; 95% CI, 0.001-0.063), but the incremental cost-effectiveness ratio was $69 585 (95% CI, $22 968-$116 201) per QALY gained, beyond the willingness-to-pay threshold.
CONCLUSIONS


Our multicomponent intervention did not improve self-rated health, health service use, or health literacy. It achieved greater improvement in quality of life than usual care, but not cost-effectively.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN12617001589370 (prospective).",2022,"The intervention was effective in terms of QALYs gained (v usual care: difference, 0.032 QALYs; 95% CI, 0.001-0.063), but the incremental cost-effectiveness ratio was $69 585 (95% CI, $22 ","['Twenty practices with a total of 92 GPs were recruited, and 1044 eligible patients participated', 'Clustered randomised controlled trial in general practices in metropolitan Adelaide', 'Three age-based groups of patients identified by their general practitioners as being at high risk of poor health outcomes: children and young people (under 18 years), adults (18-64 years) with two or more chronic diseases, and older people (65 years or more', 'patients at high risk of poor health outcomes', 'people at risk of poor health outcomes']","['Enrolment of patients with a preferred GP, longer general practice appointments, and general practice follow-up within seven days of emergency department and hospital care episodes', 'QALY', 'general practice intervention']","['hospital admissions', 'health outcomes', 'self-rated health, health service use, or health literacy', 'numbers of emergency department presentations and hospital admissions, Medicare specialist claims and Pharmaceutical Benefits Scheme (PBS) items supplied, Health Literacy Questionnaire scores, and cost-effectiveness of the intervention (based on the number of quality-adjusted life-years [QALYs] gained over 12 months, derived from EQ-5D-5L utility scores', 'self-rated health', 'numbers of emergency department presentations', 'quality of life', 'self-rated health between baseline and 12-month follow-up for control (usual care) and intervention groups', 'Medicare specialist claims', 'Health Literacy Questionnaire scores', 'incremental cost-effectiveness ratio']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205172', 'cui_str': 'More'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085554', 'cui_str': 'Episodes of Care'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",92.0,0.103895,"The intervention was effective in terms of QALYs gained (v usual care: difference, 0.032 QALYs; 95% CI, 0.001-0.063), but the incremental cost-effectiveness ratio was $69 585 (95% CI, $22 ","[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Reed', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Roeger', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA.'}, {'ForeName': 'Yuen H', 'Initials': 'YH', 'LastName': 'Kwok', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA.'}, {'ForeName': 'Billingsley', 'Initials': 'B', 'LastName': 'Kaambwa', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Allison', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Osborne', 'Affiliation': 'Swinburne University of Technology, Melbourne, VIC.'}]",The Medical journal of Australia,['10.5694/mja2.51484']
675,35388471,Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID-19 Trial of Nirmatrelvir.,"Coronavirus disease 2019 (COVID-19) is a continued leading cause of hospitalization and death. Safe, efficacious COVID-19 antivirals are needed urgently. Nirmatrelvir (PF-07321332), the first orally bioavailable, severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) M pro  inhibitor against the coronaviridae family, has demonstrated potent preclinical antiviral activity and benign safety profile. We report safety, tolerability, and pharmacokinetic data of nirmatrelvir with and without ritonavir as a pharmacokinetic enhancer, from an accelerated randomized, double-blind, placebo-controlled, phase I study. Two interleaving single-ascending dose (SAD) cohorts were evaluated in a three-period crossover. Multiple-ascending dose (MAD) with nirmatrelvir/ritonavir twice daily (b.i.d.) dosing was evaluated over 10 days in five parallel cohorts. Safety was assessed, including in a supratherapeutic exposure cohort. Dose and dosing regimen for clinical efficacy evaluation in phase II/III clinical trials were supported by integrating modeling and simulations of SAD/MAD data with nonclinical data and a quantitative systems pharmacology model (QSP). In SAD, MAD, and supratherapeutic exposure cohorts, nirmatrelvir/ritonavir was safe and well-tolerated. Nirmatrelvir exposure and half-life were considerably increased by ritonavir, enabling selection of nirmatrelvir/ritonavir dose and regimen for phase II/III trials (300/100 mg b.i.d.), to achieve concentrations continuously above those required for 90% inhibition of viral replication in vitro. The QSP model suggested that a 5-day regimen would significantly decrease viral load in SARS-CoV-2-infected patients which may prevent development of severe disease, hospitalization, and death. In conclusion, an innovative and seamless trial design expedited establishment of phase I safety and pharmacokinetics of nirmatrelvir/ritonavir, enabling high confidence in phase II/III dose selection and accelerated pivotal trials' initiation (NCT04756531).",2022,"In SAD, MAD, and supratherapeutic exposure cohorts, nirmatrelvir/ritonavir was safe and well tolerated.",[],"['nirmatrelvir with and without ritonavir', 'nirmatrelvir/ritonavir', 'placebo', 'ritonavir']","['viral load', 'safe and well tolerated', 'Nirmatrelvir exposure and half-life', 'Safety']",[],"[{'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.26081,"In SAD, MAD, and supratherapeutic exposure cohorts, nirmatrelvir/ritonavir was safe and well tolerated.","[{'ForeName': 'Ravi Shankar P', 'Initials': 'RSP', 'LastName': 'Singh', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sima S', 'Initials': 'SS', 'LastName': 'Toussi', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Pearl River, New York, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Hackman', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Cambridge, UK.'}, {'ForeName': 'Phylinda L', 'Initials': 'PL', 'LastName': 'Chan', 'Affiliation': 'Pfizer Global Product Development, Sandwich, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Allen', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Van Eyck', 'Affiliation': 'Pfizer Clinical Research Unit, Brussels, Belgium.'}, {'ForeName': 'Sylvester', 'Initials': 'S', 'LastName': 'Pawlak', 'Affiliation': 'Pfizer Clinical Research Unit, New Haven, Connecticut, USA.'}, {'ForeName': 'Eugene P', 'Initials': 'EP', 'LastName': 'Kadar', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Groton, Connecticut, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Clark', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Groton, Connecticut, USA.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer Global Product Development, Groton, Connecticut, USA.'}, {'ForeName': 'Annaliesa S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Pearl River, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Binks', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Menon', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Nucci', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Bergman', 'Affiliation': 'Pfizer Worldwide Research, Development and Medical, Cambridge, Massachusetts, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2603']
676,35390490,Physical fitness and frailty status of frail older adults in long-term care facilities after acupunch exercises: A cluster-randomized controlled trial.,"BACKGROUND


Frailty is a complex geriatric syndrome and serves as an indicator for functional degradation in older adults. Regular exercise intervention could reduce the level of frailty and improve general physical fitness. The aim of this study was to test the effects of the Vitality Acupunch (VA) exercise on the promotion of physical fitness and the improvement of frailty status among frail older adults in long-term care facilities.
METHOD


This study was a cluster-randomized controlled trial adopted a pretest-posttest design. Using convenience sampling, 81 frail adults older than 65 years of age from 10 long-term care facilities participated in this study. The older adults were cluster-randomized by facility into an intervention group (5 long-term care facilities, n = 40) and a control group (5 long-term care facilities, n = 41). The intervention group engaged in the VA exercise 3 times a week, each lasting 40 min, for 24 weeks. The control group maintained regular activities of daily living. The outcome measures for physical fitness were assessed before study began (pretest), at the 12th week (posttest 1), and at the 24th week (posttest 2) in the study.
RESULTS


After a 24-week intervention, the frail older adults who engaged in the VA exercise program showed significant improvements in handgrip strength, upper-limb muscle endurance, lung function, shoulder flexibility, forward flexion, shoulder joint flexion, and shoulder joint abduction (all p < 0.05) but not in lower-limb muscle endurance (p = 0.502) compared against their pretest data. The intervention group had significantly better physical fitness and positive changes in frailty status than the control group (all p < 0.001), except for the lower-limb muscle endurance (p = 0.557).
CONCLUSION


Regular engagement in the VA exercise program for 24 weeks significantly improved the physical fitness and frailty status of frail older adults in long-term care facilities.",2022,Regular engagement in the VA exercise program for 24 weeks significantly improved the physical fitness and frailty status of frail older adults in long-term care facilities.,"['frail older adults in long-term care facilities', 'frail older adults who engaged in the', '81 frail adults older than 65\u202fyears of age from 10 long-term care facilities participated in this study', 'frail older adults in long-term care facilities after acupunch exercises', 'older adults']","['Regular exercise intervention', 'VA exercise program', 'control group maintained regular activities of daily living', 'Vitality Acupunch (VA) exercise']","['frailty status', 'physical fitness and positive changes in frailty status', 'Physical fitness and frailty status', 'physical fitness', 'level of frailty and improve general physical fitness', 'physical fitness and frailty status', 'lower-limb muscle endurance', 'handgrip strength, upper-limb muscle endurance, lung function, shoulder flexibility, forward flexion, shoulder joint flexion, and shoulder joint abduction']","[{'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}]",81.0,0.0259131,Regular engagement in the VA exercise program for 24 weeks significantly improved the physical fitness and frailty status of frail older adults in long-term care facilities.,"[{'ForeName': 'Chia-Pei', 'Initials': 'CP', 'LastName': 'Chou', 'Affiliation': 'Department of Family Medicine, Kaohsiung Chang Gung Memorial Hospital, 123 Dapi Rd., Niaosong District, Kaohsiung 83301, Taiwan; College of Medicine, Chang Gung University, Taiwan. Electronic address: libra760924@cgmh.org.tw.'}, {'ForeName': 'Kuei-Min', 'Initials': 'KM', 'LastName': 'Chen', 'Affiliation': 'College of Nursing, Kaohsiung Medical University, 100 Shih-Chuan 1(st) Rd., Sanmin District, Kaohsiung, Taiwan; Center for Long-term Care Research, Kaohsiung Medical University, Taiwan; Department of Medical Research, Kaohsiung Medical University Hospital, Taiwan. Electronic address: kmc@kmu.edu.tw.'}, {'ForeName': 'Hsiao-Ting', 'Initials': 'HT', 'LastName': 'Tung', 'Affiliation': 'Department of Nursing, Kaohsiung Armed Forces General Hospital, 2 Zhongzheng 1st Rd., Lingya District, Kaohsiung 80284, Taiwan.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Belcastro', 'Affiliation': 'Department of Education and Psychology, University of Dubuque, 2000 University Ave., Dubuque, Iowa 52001, USA.'}, {'ForeName': 'Hui-Fen', 'Initials': 'HF', 'LastName': 'Hsu', 'Affiliation': 'Center for Long-term Care Research, Kaohsiung Medical University, 100 Shih-Chuan 1(st) Rd., Sanmin District, Kaohsiung 80708, Taiwan. Electronic address: R080152@kmu.edu.tw.'}]",Experimental gerontology,['10.1016/j.exger.2022.111799']
677,35395866,Clinical trial of insulin-like growth factor-1 in Phelan-McDermid syndrome.,"BACKGROUND


Phelan-McDermid syndrome (PMS) is caused by haploinsufficiency of the SHANK3 gene and is characterized by global developmental delays and autism spectrum disorder (ASD). Based on several converging lines of preclinical and clinical evidence supporting the use of insulin-like growth factor-1 (IGF-1) in PMS, this study aims to follow-up a previous pilot study with IGF-1 to further evaluate this novel therapeutic for core symptoms of ASD in children with PMS.
METHODS


Ten children aged 5-9 with PMS were enrolled. Participants were randomized to receive IGF-1 or placebo (saline) using a 12-week, double-blind, crossover design. Efficacy was assessed using the primary outcome of the Aberrant Behavior Checklist-Social Withdrawal (ABC-SW) subscale as well as secondary outcome measures reflecting core symptoms of ASD. To increase power and sample size, we jointly analyzed the effect of IGF-1 reported here together with results from our previous controlled trail of IGF-1 in children with PMS (combined N = 19).
RESULTS


Results on the ABC-SW did not reach statistical significance, however significant improvements in sensory reactivity symptoms were observed. In our pooled analyses, IGF-1 treatment also led to significant improvements in repetitive behaviors and hyperactivity. There were no other statistically significant effects seen across other clinical outcome measures. IGF-1 was well tolerated and there were no serious adverse events.
LIMITATIONS


The small sample size and expectancy bias due to relying on parent reported outcome measures may contribute to limitations in interpreting results.
CONCLUSION


IGF-1 is efficacious in improving sensory reactivity symptoms, repetitive behaviors, and hyperactivity  in children with PMS. Trial registration NCT01525901.",2022,"IGF-1 was well tolerated and there were no serious adverse events.
","['Ten children aged 5-9 with PMS were enrolled', 'children with PMS (combined N\u2009=\u200919', 'Phelan-McDermid syndrome', 'children with PMS']","['insulin-like growth factor-1', 'IGF-1 or placebo (saline', 'IGF-1']","['sensory reactivity symptoms, repetitive behaviors, and hyperactivity', 'sensory reactivity symptoms', 'Efficacy', 'repetitive behaviors and hyperactivity', 'Aberrant Behavior Checklist-Social Withdrawal (ABC-SW) subscale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1853490', 'cui_str': '22q13.3 deletion syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1827547', 'cui_str': 'Repetitious behavior'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0424095', 'cui_str': 'Social withdrawal'}]",10.0,0.274803,"IGF-1 was well tolerated and there were no serious adverse events.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA. alexander.kolevzon@mssm.edu.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Breen', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Siper', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Halpern', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Frank', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rieger', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weismann', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Trelles', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lerman', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rapaport', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Buxbaum', 'Affiliation': 'Seaver Autism Center for Research and Treatment, New York, NY, USA.'}]",Molecular autism,['10.1186/s13229-022-00493-7']
678,35333702,"A multicenter, single-blind, randomized, phase-2/3 study to evaluate immunogenicity and safety of a single intramuscular dose of biological E's Vi-capsular polysaccharide-CRM 197  conjugate typhoid vaccine (TyphiBEV TM ) in healthy infants, children, and adults in comparison with a licensed comparator.","The current scenario of typhoid fever warrants early prevention with typhoid conjugate vaccines in susceptible populations to provide lifelong protection. We conducted a multicenter, single-blind, randomized, Phase 2/3 study to assess the immunogenicity and safety of Biological E's Typhoid Vi-CRM 197  conjugate vaccine (TyphiBEV TM ) compared to Vi-TT conjugate vaccine manufactured by Bharat Biotech International Limited (Typbar-TCV; licensed comparator) in healthy infants, children, and adults from India. The study's primary objective was to assess the non-inferiority of TyphiBEV TM  in terms of the difference in the proportion of subjects seroconverted with a seroconversion threshold value of ≥2.0 µg/mL against Typbar-TCV. A total of 622 healthy subjects (311 each in both vaccine groups) were randomized and received the single dose of the study vaccine. The TyphiBEV TM  group demonstrated noninferiority compared to the Typbar-TCV group at Day 42. The lower 2-sided 95% confidence interval limit of the group difference was -.34%, which met the non-inferiority criteria of ≥10.0%. The geometric mean concentration (24.79 µg/mL vs. 26.58 µg/mL) and proportion of subjects who achieved ≥4-fold increase in antiVi IgG antibody concentrations (96.95% vs. 97.64%) at Day 42 were comparable between the TyphiBEV TM  and Typbar-TCV vaccine groups. No apparent difference was observed in the safety profile between both vaccine groups. All adverse events reported were mild or moderate in intensity in all age subsets. This data demonstrates that TyphiBEV TM  is non-inferior to TypbarTCV in terms of immunogenicity, and the overall safety and reactogenicity in healthy infants, children, and adults studied from India was comparable.",2022,The TyphiBEV TM  group demonstrated noninferiority compared to the Typbar-TCV group at Day 42.,"['healthy infants, children, and adults in comparison with a licensed comparator', 'healthy infants, children, and adults from India', 'healthy infants, children, and adults studied from India was comparable', '622 healthy subjects (311 each in both vaccine groups']","[""Biological E's Typhoid Vi-CRM 197  conjugate vaccine (TyphiBEV TM "", ""biological E's Vi-capsular polysaccharide-CRM 197  conjugate typhoid vaccine (TyphiBEV TM ""]","['geometric mean concentration', 'overall safety and reactogenicity', 'antiVi IgG antibody concentrations', 'safety profile', 'immunogenicity and safety']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0056499', 'cui_str': 'CRM197 (non-toxic variant of diphtheria toxin)'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0041469', 'cui_str': 'Typhoid vaccine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",622.0,0.152069,The TyphiBEV TM  group demonstrated noninferiority compared to the Typbar-TCV group at Day 42.,"[{'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Thuluva', 'Affiliation': 'Clinical Development Department, Biological E Limited, Hyderabad, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Paradkar', 'Affiliation': 'Clinical Development Department, Biological E Limited, Hyderabad, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Matur', 'Affiliation': 'Clinical Development Department, Biological E Limited, Hyderabad, India.'}, {'ForeName': 'Kishore', 'Initials': 'K', 'LastName': 'Turaga', 'Affiliation': 'Clinical Development Department, Biological E Limited, Hyderabad, India.'}, {'ForeName': 'Subba Reddy', 'Initials': 'SR', 'LastName': 'Gv', 'Affiliation': 'Clinical Development Department, Biological E Limited, Hyderabad, India.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2043103']
679,35334422,A preliminary study on the effects of an osteoporosis prevention program based on an Information-Motivation-Behavioral skill model in older adult women: A cluster randomized controlled trial.,"We aimed to evaluate the feasibility and effects of an osteoporosis prevention program using the Information-Motivation-Behavioral skill (IMB) model in older adult women in this preliminary study. Korean women ≥65 years were randomly assigned to control (N=21) and intervention (N=23) groups. The intervention group participated in an IMB model-based, 12-week osteoporosis prevention program. The primary outcome was osteoporosis prevention behavior over time in both groups directly before, immediately after (post-test 1), and 4 weeks after (post-test 2) the intervention. Participants had a higher retention and attendance rate for the intervention, and the osteoporosis prevention behavior of the intervention group at post-test 1 and post-test 2 had significantly improved. The program based on the IMB model may be a feasible and effective intervention for osteoporosis prevention behavior in older adult women.",2022,"Participants had a higher retention and attendance rate for the intervention, and the osteoporosis prevention behavior of the intervention group at post-test 1 and post-test 2 had significantly improved.","['older adult women', 'Korean women ≥65 years']","['osteoporosis prevention program', 'osteoporosis prevention program using the Information-Motivation-Behavioral skill (IMB) model', 'IMB model-based, 12-week osteoporosis prevention program']","['osteoporosis prevention behavior', 'osteoporosis prevention behavior over time', 'higher retention and attendance rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3650929', 'cui_str': 'Prevention of osteoporosis'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3650929', 'cui_str': 'Prevention of osteoporosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0135497,"Participants had a higher retention and attendance rate for the intervention, and the osteoporosis prevention behavior of the intervention group at post-test 1 and post-test 2 had significantly improved.","[{'ForeName': 'Yeongsuk', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Catholic University of Pusan, 57 Oryundae-ro, Geumjeong-gu, Busan 46252, Republic of Korea. Electronic address: lys3316@cup.ac.kr.'}, {'ForeName': 'Dong-Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Pusan National University, 49 Busandaehak-ro, Mulgeum-eup, Yangsan-si 50612, Republic of Korea. Electronic address: dongheekim@pusan.ac.kr.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.03.001']
680,35343353,Bright light exposure during simulated night work improves cognitive flexibility.,"Night work leads to sleepiness and reduced vigilant attention during work hours, and bright light interventions may reduce such effects. It is also known that total sleep deprivation impairs cognitive flexibility as measured by reversal learning tasks. Whether night work impairs reversal learning task performance or if bright light can mitigate reversal learning deficits during night work is unclear. In this counterbalanced crossover study (ClinicaTrials.gov Identifier NCT03203538), young healthy individuals completed a reversal learning task twice during each of three consecutive simulated night shifts (23:00-07:00 h). The night shifts were performed in a laboratory under a full-spectrum (4000 K) bright light (~900 lx) and a standard light (~90 lx) condition. Reversal learning task performance was reduced towards the end of the night shifts (04:50 h), compared to the first part of the night shifts (00:20 h) in both light conditions. However, with bright light, the reversal learning task performance improved towards the end of the night shifts, compared to standard light. The study shows that bright light may mitigate performance deficits on a reversal learning task during night work and implies that bright light interventions during night work may be beneficial not only for vigilant attention but also for cognitive flexibility.",2022,"Reversal learning task performance was reduced towards the end of the night shifts (04:50 h), compared to the first part of the night shifts (00:20 h) in both light conditions.",['young healthy individuals'],['reversal learning task'],"['cognitive flexibility', 'reversal learning task performance', 'Reversal learning task performance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0035375', 'cui_str': 'Reversal Learning'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0035375', 'cui_str': 'Reversal Learning'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.0416602,"Reversal learning task performance was reduced towards the end of the night shifts (04:50 h), compared to the first part of the night shifts (00:20 h) in both light conditions.","[{'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Sunde', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Mrdalj', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Torhild T', 'Initials': 'TT', 'LastName': 'Pedersen', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bjorvatn', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Waage', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}]",Chronobiology international,['10.1080/07420528.2022.2050922']
681,35349397,"Association between Type of Fluid Received Prior to Enrollment, Type of Admission, and Effect of Balanced Crystalloid in Critically Ill Adults: A Secondary Exploratory Analysis of the BaSICS Clinical Trial.","Rationale:  The effects of balanced crystalloid versus saline on clinical outcomes for ICU patients may be modified by the type of fluid that patients received for initial resuscitation and by the type of admission.  Objectives:  To assess whether the results of a randomized controlled trial could be affected by fluid use before enrollment and admission type.  Methods:  Secondary  post hoc  analysis of the BaSICS (Balanced Solution in Intensive Care Study) trial, which compared a balanced solution (Plasma-Lyte 148) with 0.9% saline in the ICU. Patients were categorized according to fluid use in the 24 hours before enrollment in four groups (balanced solutions only, 0.9% saline only, a mix of both, and no fluid before enrollment) and according to admission type (planned, unplanned with sepsis, and unplanned without sepsis). The association between 90-day mortality and the randomization group was assessed using a hierarchical logistic Bayesian model.  Measurements and Main Results:  A total of 10,520 patients were included. There was a low probability that the balanced solution was associated with improved 90-day mortality in the whole trial population (odds ratio [OR], 0.95; 89% credible interval [CrI], 0.66-10.51; probability of benefit, 0.58); however, probability of benefit was high for patients who received only balanced solutions before enrollment (regardless of admission type, OR, 0.78; 89% CrI, 0.56-1.03; probability of benefit, 0.92), mostly because of a benefit in unplanned admissions due to sepsis (OR, 0.70; 89% CrI, 0.50-0.97; probability of benefit, 0.96) and planned admissions (OR, 0.79; 89% CrI, 0.65-0.97; probability of benefit, 0.97).  Conclusions:  There is a high probability that balanced solution use in the ICU reduces 90-day mortality in patients who exclusively received balanced fluids before trial enrollment. Clinical trial registered with www.clinicaltrials.gov (NCT02875873).",2022,"There was a low probability that the balanced solution was associated with improved 90-day mortality in the whole trial population (odds ratio, 0.95; 89% credible intervals [CrI], 0.66-1.51; probability of benefit, 0.58); however, probability of benefit was high for patients that received only balanced solutions before enrollment (regardless of admission type, odds ratio, 0.78, 89% CrI, 0.56,1.03; probability of benefit, 0.92), mostly due to a benefit in unplanned admissions due to sepsis (odd ratio, 0.70; 89% CrI, 0.50-0.97; probability of benefit, 0.96) and planned admissions (odds ratio, 0.79; 89% CrI, 0.65-0.97; 0.97 probability of benefit, 0.97).
","['10,520 patients were included', 'Critically Ill Adults', 'intensive care unit patients']","['Balanced Crystalloid', 'balanced crystalloid vs saline', 'balanced solution to 0.9% saline']","['probability of benefit', '90-day mortality', 'planned admissions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320674', 'cui_str': 'Planned admission'}]",10520.0,0.338112,"There was a low probability that the balanced solution was associated with improved 90-day mortality in the whole trial population (odds ratio, 0.95; 89% credible intervals [CrI], 0.66-1.51; probability of benefit, 0.58); however, probability of benefit was high for patients that received only balanced solutions before enrollment (regardless of admission type, odds ratio, 0.78, 89% CrI, 0.56,1.03; probability of benefit, 0.92), mostly due to a benefit in unplanned admissions due to sepsis (odd ratio, 0.70; 89% CrI, 0.50-0.97; probability of benefit, 0.96) and planned admissions (odds ratio, 0.79; 89% CrI, 0.65-0.97; 0.97 probability of benefit, 0.97).
","[{'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo S', 'Initials': 'RS', 'LastName': 'Biondi', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Flávio G R', 'Initials': 'FGR', 'LastName': 'Freitas', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo C', 'Initials': 'RC', 'LastName': 'Figueiredo', 'Affiliation': 'Hospital Maternidade São José, Centro Universitário do Espírito Santo, Colatina, Brazil.'}, {'ForeName': 'Wilson J', 'Initials': 'WJ', 'LastName': 'Lovato', 'Affiliation': 'Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Cristina P', 'Initials': 'CP', 'LastName': 'Amêndola', 'Affiliation': 'Fundação Pio XII, Hospital de Câncer de Barretos, Barretos, Brazil.'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa-Neto', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Jorge L R', 'Initials': 'JLR', 'LastName': 'Paranhos', 'Affiliation': 'Santa Casa de Misericórdia de São João Del Rei, São João Del Rei, Brazil.'}, {'ForeName': 'Eraldo A', 'Initials': 'EA', 'LastName': 'Lúcio', 'Affiliation': 'Hospital São Francisco, Santa Casa de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Lúcio C', 'Initials': 'LC', 'LastName': 'Oliveira-Júnior', 'Affiliation': 'Hospital Geral Clériston Andrade, Feira de Santana, Brazil.'}, {'ForeName': 'Thiago C', 'Initials': 'TC', 'LastName': 'Lisboa', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Fábio H', 'Initials': 'FH', 'LastName': 'Lacerda', 'Affiliation': 'Hospital da Luz, São Paulo, Brazil.'}, {'ForeName': 'Israel S', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Cintia M C', 'Initials': 'CMC', 'LastName': 'Grion', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Murillo S C', 'Initials': 'MSC', 'LastName': 'Assunção', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Airton L O', 'Initials': 'ALO', 'LastName': 'Manoel', 'Affiliation': 'Hospital Paulistano, São Paulo, Brazil.'}, {'ForeName': 'Thiago D', 'Initials': 'TD', 'LastName': 'Corrêa', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Marco Antonio V A', 'Initials': 'MAVA', 'LastName': 'Guedes', 'Affiliation': 'Hospital Ana Nery, Salvador, Brazil.'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Tamiris A', 'Initials': 'TA', 'LastName': 'Miranda', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Nilton', 'Initials': 'N', 'LastName': 'Brandão da Silva', 'Affiliation': 'School of Medicine, Federal University of Health Sciences, Porto Alegre, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202111-2484OC']
682,35351371,SOCRATE-PRODIGE 55 trial: A randomized phase II study to evaluate second-line ramucirumab alone or with paclitaxel in older patients with advanced gastric cancer.,"INTRODUCTION


Patients ≥ 70 years old constitute 40% of patients with advanced gastric cancer (GC). Ramucirumab plus Paclitaxel is a therapeutic option validated in the second-line treatment of advanced GC, but as older patients are at higher risk of severe toxicity, due to comorbidities and/or frailty, we aimed to evaluate second-line Ramucirumab alone or combined with Paclitaxel in terms of overall survival (OS) and quality of life (QoL) in patients ≥ 70 years-old with advanced GC.
METHODS


In this multicenter, randomized, open-label, non-comparative, prospective phase II clinical trial, the main inclusion criteria are: patients ≥ 70 years old, with advanced GC having progressed after first-line chemotherapy or in the six months following the last administration of adjuvant chemotherapy, with WHO performance status <2. They are randomized to receive either ramucirumab alone (arm A) or ramucirumab plus Paclitaxel (arm B). The primary endpoint is 6-month OS and QoL evaluated with the EORTC QLQ-ELD14 questionnaire. The secondary endpoints include other parameters of QoL, time to definitive deterioration (TTDD) in QoL and TTDD in autonomy, treatment toxicities, other parameters of survival and disease control, identification of geriatric and nutritional prognostic scores and predictive factors of treatment safety and efficacy. OS of 60% is expected at 6 months (H0:40%). Using a Simon-minimax design, with one-sided α risk of 2% and 80% power for OS, and considering 5% lost to follow-up, it is necessary to randomize 56 patients in each arm.
PERSPECTIVES


As older patients are at higher risk of chemotherapy toxicity, ramucirumab alone could be an interesting alternative to Paclitaxel plus ramucirumab, as a second-line therapy for patients ≥ 70 years old with advanced GC, and needs to be evaluated.",2022,"The secondary endpoints include other parameters of QoL, time to definitive deterioration (TTDD) in QoL and TTDD in autonomy, treatment toxicities, other parameters of survival and disease control, identification of geriatric and nutritional prognostic scores and predictive factors of treatment safety and efficacy.","['Patients ≥ 70 years old constitute 40% of patients with advanced gastric cancer (GC', 'older patients with advanced gastric cancer', 'main inclusion criteria are: patients ≥ 70 years old, with advanced GC having progressed after first-line chemotherapy or in the six months following the last administration of adjuvant chemotherapy, with WHO performance status <2', 'patients ≥ 70 years-old with advanced GC']","['Paclitaxel', 'ramucirumab alone (arm A) or ramucirumab plus Paclitaxel', 'second-line ramucirumab alone or with paclitaxel', 'Ramucirumab plus Paclitaxel']","['parameters of QoL, time to definitive deterioration (TTDD) in QoL and TTDD in autonomy, treatment toxicities, other parameters of survival and disease control, identification of geriatric and nutritional prognostic scores and predictive factors of treatment safety and efficacy', 'overall survival (OS) and quality of life (QoL', '6-month OS and QoL evaluated with the EORTC QLQ-ELD14 questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0449821', 'cui_str': 'Prognostic score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0353082,"The secondary endpoints include other parameters of QoL, time to definitive deterioration (TTDD) in QoL and TTDD in autonomy, treatment toxicities, other parameters of survival and disease control, identification of geriatric and nutritional prognostic scores and predictive factors of treatment safety and efficacy.","[{'ForeName': 'Emeric', 'Initials': 'E', 'LastName': 'Boisteau', 'Affiliation': ""Service des Maladies de l'Appareil Digestif, INSERM U1242, CHU de Rennes, CHU Pontchaillou, Université de Rennes 1, Rennes Cedex9 35033, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'François', 'Affiliation': ""Service d'Oncologie, Center Antoine Lacassagne, Nice, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Aparicio', 'Affiliation': 'Service de Gastroentérologie, Hôpital Saint Louis, APHP, Université de Paris, Paris, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'FFCD EPICAD INSERM LNC-UMR 1231, Université de Bourgogne Franche-Comté Dijon, France.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Boulahssass', 'Affiliation': 'Service de Gériatrie, CHU de Nice, Nice, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Service d\'Hépato-Gastroentérologie, CHU de Tours, Tours, France; INSERM UMR 1069, ""Nutrition, Croissance et Cancer"", Université de Tours, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent-Puig', 'Affiliation': 'INSERM U 775 - Faculté des Sciences Fondamentales et Biomédicales, Center Universitaire des Saints-Pères, Université des Saints Pères, Paris Descartes, Paris, France.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Guiu', 'Affiliation': 'Département de Radiologie, CHU St-Eloi, Montpellier, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Paillaud', 'Affiliation': 'Hôpital Européen Georges Pompidou, Service de Gériatrie, APHP, Paris Cancer Institute CARPEM, Paris 75015, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Galais', 'Affiliation': ""Département d'Oncologie Médiale, Center François Baclesse, Caen, France.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lopez-Trabada Ataz', 'Affiliation': ""Département d'Oncologie Médiale, Hôpital Saint-Antoine, Paris, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': ""Service d'Hépato-gastroentérologie, CHU de Poitiers, La Milétrie, et l'Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Louis-Marie', 'Initials': 'LM', 'LastName': 'Dourthe', 'Affiliation': ""Service d'Oncologie Médicale, Clinique St Anne, Strasbourg, France.""}, {'ForeName': 'Rosine', 'Initials': 'R', 'LastName': 'Guimbaud', 'Affiliation': ""Département d'Oncologie Médicale, Pôle Digestif, CHU Toulouse, Toulouse, France.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Samalin', 'Affiliation': ""Département d'Oncologie Médicale, Institut du Cancer de Montpellier, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Moreau', 'Affiliation': 'Fédération Francophone de Cancérologie Digestive (FFCD), Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': ""Service d'Oncologie Médicale, Institut Mutualiste Montsouris, Paris, France.""}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': ""Service d'Hépato-gastroentérologie, CHU de Dijon, Dijon, France.""}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Lièvre', 'Affiliation': ""Service des Maladies de l'Appareil Digestif, INSERM U1242, CHU de Rennes, CHU Pontchaillou, Université de Rennes 1, Rennes Cedex9 35033, France. Electronic address: astrid.lievre@chu-rennes.fr.""}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2022.03.001']
683,35366419,"AJM300 (carotegrast methyl), an oral antagonist of α4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND


AJM300 is an oral, small-molecule α4-integrin antagonist. We assessed the efficacy and safety of AJM300 in patients with moderately active ulcerative colitis.
METHODS


This multicentre, randomised, double-blind, placebo-controlled, phase 3 study consisted of two phases: a treatment phase and an open-label re-treatment phase. The study was done at 82 hospitals and clinics in Japan. Patients with a Mayo Clinic score of 6-10, endoscopic subscore of 2 or more, rectal bleeding subscore of 1 or more, and an inadequate response or intolerance to mesalazine were enrolled. Patients were randomly allocated (1:1) via a website to either AJM300 (960 mg) or placebo by the minimisation method, which was adjusted centrally by dynamic assignment against the Mayo Clinic score (≥6 to ≤7, ≥8 to ≤10 points), any use of corticosteroid, anti-TNFα antibody, or immunosuppressants during the disease-active period (yes vs no), duration of induction therapy until randomisation (<4 weeks vs ≥4 weeks) as the minimisation factors. Patients, investigators, site staff, assessors, and the sponsor were masked to treatment assignments. The study drug was administered orally, three times daily, for 8 weeks, and continued for up to 24 weeks if endoscopic remission was not achieved or rectal bleeding did not stop. The primary endpoint was the proportion of patients with a clinical response at week 8, and was analysed in the full analysis set. Clinical response was defined as a reduction in Mayo Clinic score of 30% or more and 3 or more, a reduction in rectal bleeding score of 1 or more or rectal bleeding subscore of 1 or less, and an endoscopic subscore of 1 or less at week 8. The study is registered with ClinicalTrials.gov, NCT03531892, and is closed to recruitment.
FINDINGS


Between June 6, 2018, and July 22, 2020, 203 patients were randomly assigned to AJM300 (n=102) or placebo (n=101). At week 8, 46 (45%) patients in the AJM300 group and 21 (21%) patients in the placebo group had a clinical response (odds ratio 3·30, 95% CI 1·73-6·29; p=0·00028). During the 8-week treatment and 16-week extension treatment periods, adverse events occurred in 39 (39%) of 101 patients in the placebo group and 39 (38%) of 102 patients in the AJM300 group. We found no difference in the incidence of adverse events between groups or after repeated administration of AJM300. The most common adverse event was nasopharyngitis (11 [11%] of 101 patients in the placebo group and ten [10%] of 102 patients in the AJM300 group). The most common treatment-related adverse event was also nasopharyngitis (four [4%] of 101 patients in the placebo group and three [3%] of 102 patients in the AJM300 group). Most adverse events were mild-to-moderate in severity. No deaths were reported. A serious adverse event was reported in the AJM300 group (one patient with anal abscess), but this was judged to be unrelated to study drug.
INTERPRETATION


AJM300 was well tolerated and induced a clinical response in patients with moderately active ulcerative colitis who had an inadequate response or intolerance to mesalazine. AJM300 could be a novel induction therapy for the treatment of patients with moderately active ulcerative colitis.
FUNDING


EA Pharma and Kissei Pharmaceutical.
TRANSLATION


For the Japanese translation of the abstract see Supplementary Materials section.",2022,The most common adverse event was nasopharyngitis (11 [11%] of 101 patients in the placebo group and ten [10%] of 102 patients in the AJM300 group).,"['patients with moderately active ulcerative colitis', '203 patients', 'patients with moderately active ulcerative colitis who had an inadequate response or intolerance to', 'Patients with a Mayo Clinic score of 6-10, endoscopic subscore of 2 or more, rectal bleeding subscore of 1 or more, and an inadequate response or intolerance to mesalazine were enrolled', '82 hospitals and clinics in Japan', 'Between June 6, 2018, and July 22, 2020']","['AJM300', 'corticosteroid, anti-TNFα antibody, or immunosuppressants during the disease-active period (yes vs no), duration of induction therapy until randomisation', 'AJM300 (carotegrast methyl), an oral antagonist of α4-integrin', 'placebo', 'mesalazine']","['clinical response', 'incidence of adverse events', 'rectal bleeding score of 1 or more or rectal bleeding subscore', 'adverse events', 'nasopharyngitis', 'proportion of patients with a clinical response', 'efficacy and safety', 'Mayo Clinic score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C3852241', 'cui_str': 'AJM300'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",203.0,0.304425,The most common adverse event was nasopharyngitis (11 [11%] of 101 patients in the placebo group and ten [10%] of 102 patients in the AJM300 group).,"[{'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, Toho University Sakura Medical Center, Sakura, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Tokyo Medical and Dental University, Advanced Research Institute and Department of Gastroenterology and Hepatology, Tokyo, Japan. Electronic address: mamoru.gast@tmd.ac.jp.'}, {'ForeName': 'Toshihide', 'Initials': 'T', 'LastName': 'Ohmori', 'Affiliation': 'Department of Gastroenterology, Ohmori Toshihide Gastro-intestinal Clinic, Ageo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastrointestinal Division, Matsushima Clinic, Yokohama, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Ishida', 'Affiliation': 'Department of IBD and Gastroenterology, Ishida Clinic of IBD and Gastroenterology, Oita, Japan.'}, {'ForeName': 'Yoh', 'Initials': 'Y', 'LastName': 'Ishiguro', 'Affiliation': 'Department of Gastroenterology and Hematology, National Hospital Organization Hirosaki National Hospital, Hirosaki, Japan.'}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Kanke', 'Affiliation': 'Gastrointestinal Division, Kanke Gastrointestinal Clinic, Utsunomiya, Japan.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Hirai', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Division of Internal Medicine, Center for Inflammatory Bowel Disease, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Mizusawa', 'Affiliation': 'Department of Neurology, National Center of Neurology and Psychiatry Hospital, Tokyo, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Kishida', 'Affiliation': 'Cranial Nerve Internal Medicine Department, Narita Tomisato Tokushukai Hospital, Tomisato, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Miura', 'Affiliation': 'Department of Neurology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ohta', 'Affiliation': 'Clinical Development Department, EA Pharma, Tokyo, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Kajioka', 'Affiliation': 'Clinical Development Department, EA Pharma, Tokyo, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(22)00022-X']
684,35379019,Intra-articular injection with platelet-rich plasma compared to triamcinolone hexacetonide or saline solution in knee osteoarthritis: A double blinded randomized controlled trial with one year follow-up.,"OBJECTIVES


To compare the effectiveness of intra-articular injection (IAI) of Platelet-Rich Plasma (PRP) with Triamcinolone Hexacetonide (TH) and Saline Solution (SS), in patients with knee osteoarthritis (OA).
DESIGN


A randomized controlled trial, with blinded patients and assessor.
SETTING


Outpatient rheumatology service.
SUBJECTS


Patients with knee osteoarthritis grades II and III.
INTERVENTIONS


Patients received IAI with PRP, 40 mg TH, or SS.
METHODS


Patients were assessed at baseline and after 4, 8, 12 e 52 weeks with: visual analogue scale (VAS) for pain at rest and movement, WOMAC questionnaire, Timed to Up and Go test, 6-min walk test, percentage of improvement, goniometry, quality of life SF-36 questionnaire, Likert scale and Kelgreen & Lawrence (KL) radiographic scale (only at baseline and 52 weeks).
RESULTS


100 patients were studied, with a mean age of 67.13(6.56) years. The TH group was superior for: percentage of improvement (versus SS group from 4 to 52 weeks); WOMAC total and pain (versus PRP group at 4 weeks); and WOMAC stiffness (versus SS group at 12 weeks). The SS group was inferior for WOMAC function (from 8 to 52 weeks). The PRP group showed lowest radiographic progression [TH 17 (51.51%) to 24 (72.72%); SS 17 (51.51%) to 30 (90.90%); PRP 20 (58.82%) to 21 (61.76%)].
CONCLUSION


The Triamcinolone Hexacetonide group was superior for percentage of improvement and WOMAC, pain and stiffness. For the WOMAC function, the Platelet-Rich Plasma group and Triamcinolone Hexacetonide group were superior to the Saline group. The Platelet-Rich Plasma group showed the lowest radiographic progression at 52 weeks of follow-up.",2022,"The Triamcinolone Hexacetonide group was superior for percentage of improvement and WOMAC, pain and stiffness.","['patients with knee osteoarthritis (OA', 'Outpatient rheumatology service', 'Patients were assessed at baseline and after 4, 8, 12 e 52 weeks with', '100 patients were studied, with a mean age of 67.13(6.56) years', 'Patients with knee osteoarthritis grades II and III', 'knee osteoarthritis']","['Triamcinolone Hexacetonide', 'intra-articular injection (IAI) of Platelet-Rich Plasma (PRP) with Triamcinolone Hexacetonide (TH) and Saline Solution (SS', 'triamcinolone hexacetonide or saline solution', 'IAI with PRP, 40\u2005mg TH, or SS']","['percentage of improvement and WOMAC, pain and stiffness', 'WOMAC stiffness', 'radiographic progression', 'visual analogue scale (VAS) for pain at rest and movement, WOMAC questionnaire, Timed to Up and Go test, 6-min walk test, percentage of improvement, goniometry, quality of life SF-36 questionnaire, Likert scale and Kelgreen & Lawrence (KL) radiographic scale', 'WOMAC total and pain', 'lowest radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587593', 'cui_str': 'Rheumatology service'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0077004', 'cui_str': 'Triamcinolone hexacetonide'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",100.0,0.164498,"The Triamcinolone Hexacetonide group was superior for percentage of improvement and WOMAC, pain and stiffness.","[{'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Nunes-Tamashiro', 'Affiliation': 'Academic of Rheumatology Division, 58804from Universidade Federal de São Paulo- Escola Paulista de Medicina (Unifesp - EPM), Sao Paulo, Brazil.'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Natour', 'Affiliation': 'Professor of Rheumatology Division and Head of Ambulatory of Rheumatology Interventions, 28105from Universidade Federal de São Paul o- Escola Paulista de Medicina (Unifesp - EPM), Sao Paulo, Brazil.'}, {'ForeName': 'Fernando Maier', 'Initials': 'FM', 'LastName': 'Ramuth', 'Affiliation': 'Academic of Rheumatology Division, 58804from Universidade Federal de São Paulo- Escola Paulista de Medicina (Unifesp - EPM), Sao Paulo, Brazil.'}, {'ForeName': 'Sandra Regina', 'Initials': 'SR', 'LastName': 'Toffolo', 'Affiliation': 'Academic of Rheumatology Division, 58804from Universidade Federal de São Paulo- Escola Paulista de Medicina (Unifesp - EPM), Sao Paulo, Brazil.'}, {'ForeName': 'Jamile Godoy', 'Initials': 'JG', 'LastName': 'Mendes', 'Affiliation': 'Academic of Rheumatology Division, 58804from Universidade Federal de São Paulo- Escola Paulista de Medicina (Unifesp - EPM), Sao Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Diagnostic Imaging, 28105from Universidade Federal de São Paulo - Escola Paulista de Medicina (Unifesp - EPM), Sao Paulo, Brazil.'}, {'ForeName': 'Rita Nely Vilar', 'Initials': 'RNV', 'LastName': 'Furtado', 'Affiliation': '28105Rheumatologist and Physiatrist Affiliated Professor from Universidade Federal de São Paulo - Escola Paulista de Medicina (Unifesp - EPM), Sao Paulo, Brazil.'}]",Clinical rehabilitation,['10.1177/02692155221090407']
685,35367955,Static and treatment-responsive brain biomarkers of depression relapse vulnerability following prophylactic psychotherapy: Evidence from a randomized control trial.,"BACKGROUND


Neural reactivity to dysphoric mood induction indexes the tendency for distress to promote cognitive reactivity and sensory avoidance. Linking these responses to illness prognosis following recovery from Major Depressive Disorder informs our understanding of depression vulnerability and provides engagement targets for prophylactic interventions.
METHODS


A prospective fMRI neuroimaging design investigated the relationship between dysphoric reactivity and relapse following prophylactic intervention. Remitted depressed outpatients (N = 85) were randomized to 8 weeks of Cognitive Therapy with a Well-Being focus or Mindfulness Based Cognitive Therapy. Participants were assessed before and after therapy and followed for 2 years to assess relapse status. Neural reactivity common to both assessment points identified static biomarkers of relapse, whereas reactivity change identified dynamic biomarkers.
RESULTS


Dysphoric mood induction evoked prefrontal activation and sensory deactivation. Controlling for past episodes, concurrent symptoms and medication status, somatosensory deactivation was associated with depression recurrence in a static pattern that was unaffected by prophylactic treatment, HR 0.04, 95% CI [0.01, 0.14], p < .001. Treatment-related prophylaxis was linked to reduced activation of the left lateral prefrontal cortex (LPFC), HR 3.73, 95% CI [1.33, 10.46], p = .013. Contralaterally, the right LPFC showed dysphoria-evoked inhibitory connectivity with the right somatosensory biomarker CONCLUSIONS: These findings support a two-factor model of depression relapse vulnerability, in which: enduring patterns of dysphoria-evoked sensory deactivation contribute to episode return, but vulnerability may be mitigated by targeting prefrontal regions responsive to clinical intervention. Emotion regulation during illness remission may be enhanced by reducing prefrontal cognitive processes in favor of sensory representation and integration.",2022,"Treatment-related prophylaxis was linked to reduced activation of the left lateral prefrontal cortex (LPFC), HR 3.73, 95% CI [1.33, 10.46], p = .013.",['Remitted depressed outpatients (N\u202f=\u202f85'],"['Cognitive Therapy with a Well-Being focus or Mindfulness Based Cognitive Therapy', 'Static and treatment-responsive brain biomarkers', 'prophylactic psychotherapy']","['dysphoric reactivity and relapse', 'depression recurrence']","[{'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",85.0,0.124005,"Treatment-related prophylaxis was linked to reduced activation of the left lateral prefrontal cortex (LPFC), HR 3.73, 95% CI [1.33, 10.46], p = .013.","[{'ForeName': 'Norman A S', 'Initials': 'NAS', 'LastName': 'Farb', 'Affiliation': 'Department of Psychology, University of Toronto Mississauga, 3359 Mississauga Road, Mississauga, Ontario L5L 1C6, Canada; Graduate Department of Psychological Clinical Science, University of Toronto Scarborough, 1265 Military Trail, Toronto, ON M1C 1A4, Canada. Electronic address: norman.farb@utoronto.ca.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Desormeau', 'Affiliation': 'Graduate Department of Psychological Clinical Science, University of Toronto Scarborough, 1265 Military Trail, Toronto, ON M1C 1A4, Canada.'}, {'ForeName': 'Adam K', 'Initials': 'AK', 'LastName': 'Anderson', 'Affiliation': 'College of Human Ecology, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Zindel V', 'Initials': 'ZV', 'LastName': 'Segal', 'Affiliation': 'Graduate Department of Psychological Clinical Science, University of Toronto Scarborough, 1265 Military Trail, Toronto, ON M1C 1A4, Canada.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2022.102969']
686,35384852,"Support for Texting-Based Condom Negotiation Among Forcibly Displaced Adolescents in the Slums of Kampala, Uganda: Cross-sectional Validation of the Condom Use Negotiated Experiences Through Technology Scale.","BACKGROUND


Promoting sexual health among forcibly displaced adolescents is a global public health priority. Digital sexual communication strategies (eg, sexting) may increase adolescents' confidence in discussing sexual health issues and negotiating condom use. However, limited evidence exists describing validated measures for text-based condom negotiation in the literature.
OBJECTIVE


This study helps fill this gap by adapting and examining the psychometric properties of a condom use experience through technology (condom use negotiated experiences through technology [CuNET]) scale.
METHODS


Using peer network sampling, 242 forcibly displaced adolescents (aged 16-19 years) living in Kampala's slums were recruited for participation between January and March 2018. A subscale (embarrassment to negotiate condom use) of the Multidimensional Condom Attitudes Scale was adapted to incorporate sexting, yielding CuNET. Participants were randomly assigned to calibration and validation subsamples to conduct exploratory and confirmatory factor analyses to establish and validate the scale. CuNET measured participants' support levels for texting-based condom negotiation via sexting based on gender, and multivariable logistic regression was used to explore its associations with sexual health outcomes (recent consistent condom use, access to sexual and reproductive health services, and lifetime sexually transmitted infection testing).
RESULTS


The one-factor CuNET with the validation sample was valid (χ 2 4 =5.3; P=.26; root mean square error of approximation=0.05, 90% CI 0.00-0.16; comparative fit index=0.99; Tucker-Lewis index=0.99; standardized root mean square residual=0.006), and reliability (Cronbach α=.98). Adolescent girls showed significantly lower levels of support for using sexting to negotiate condom use (mean 13.60, SE 0.70 vs mean 21.48, SE 1.23; P=.001). In multivariable analyses, a 1-point increase in the CuNET score was associated with increased odds of recent consistent condom use (adjusted odds ratio [aOR] 1.73, 95% CI 1.24-2.41) but not with access to sexual and reproductive health services (aOR 1.51, 95% CI 0.99-2.30) or lifetime sexually transmitted infection testing (aOR 0.90, 95% CI 0.64-1.26).
CONCLUSIONS


The unidimensional CuNET scale is valid and reliable for forcibly displaced adolescents living in slums in Kampala, gender-sensitive, and relevant for predicting consistent condom use among urban displaced and refugee adolescents. Further development of this scale will enable a better understanding of how adolescents use digital tools for condom negotiation.",2022,"The unidimensional CuNET scale is valid and reliable for forcibly displaced adolescents living in slums in Kampala, gender-sensitive, and relevant for predicting consistent condom use among urban displaced and refugee adolescents.","['Adolescent girls', ""242 forcibly displaced adolescents (aged 16-19 years) living in Kampala's slums were recruited for participation between January and March 2018""]","['Texting-Based Condom Negotiation', 'Digital sexual communication strategies (eg, sexting']","['CuNET score', 'sexual and reproductive health services', 'lifetime sexually transmitted infection testing']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1136000', 'cui_str': 'Reproductive Health Services'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",,0.0560033,"The unidimensional CuNET scale is valid and reliable for forcibly displaced adolescents living in slums in Kampala, gender-sensitive, and relevant for predicting consistent condom use among urban displaced and refugee adolescents.","[{'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Okumu', 'Affiliation': 'School of Social Work, University of Illinois, Urbana-Champaign, Urbana, IL, United States.'}, {'ForeName': 'Carmen H', 'Initials': 'CH', 'LastName': 'Logie', 'Affiliation': 'Factor Inwentash Faculty of Social Work, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ansong', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mwima', 'Affiliation': 'School of Social Work, University of Illinois, Urbana-Champaign, Urbana, IL, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hakiza', 'Affiliation': 'Young African Refugees for Integral Development, Kampala, Uganda.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Newman', 'Affiliation': 'Factor Inwentash Faculty of Social Work, University of Toronto, Toronto, ON, Canada.'}]",JMIR public health and surveillance,['10.2196/27792']
687,35381407,Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: A randomized controlled trial.,"BACKGROUND


Low molecular weight heparins (LMWH) are recommended for thromboprophylaxis in ICU patients but often fail to reach adequate peak anti-Xa activity.
OBJECTIVE


To compare the pharmacokinetic profiles of intravenous (IV) versus subcutaneous (SC) route of administration of LMWH.
METHOD


This was a prospective, monocentric, randomized trial. Patients were randomized to the IV route of administration with a 4-h infusion of nadroparin 3800 IU or to the SC route of administration. Randomization was stratified according to the need for vasopressor or not. Anti-Xa activity was measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 h after the administration was started.
RESULTS


Sixty patients were included, of whom 30 were randomized to the IV group and 30 to the SC route. Pharmacokinetic profiles were significantly different. Mean peak anti-Xa activity was 0.38 IU/ml in the IV group vs 0.20 IU/ml in the SC group (p < 0.001). Trough values and AUC (0-24 h) were similar in both groups. Pharmacokinetic profiles were similar whether patients received vasopressors or not.
CONCLUSIONS


The IV route of administration with a 4-h infusion lead to a significantly higher peak anti-Xa activity without affecting trough value or the AUC (0-24 h). Whether the IV administration of LMWH might improve the efficacy of thromboprophylaxis requires further research.
REGISTRATION


ClinicalTrials.gov, NCT04982055, retrospectively registered 08 July 2021, https://clinicaltrials.gov/ct2/show/NCT04982055?cond=NCT04982055&draw=2&rank=1.",2022,Xa activity was 0.38 IU/ml in the IV group vs 0.20 IU/ml in the SC group (p < 0.001).,"['Sixty patients', 'critically ill patients', 'ICU patients']","['nadroparin', 'LMWH', 'intravenous (IV) versus subcutaneous (SC) route of administration of LMWH', 'intravenous versus subcutaneous administration of low molecular weight heparin']","['Mean peak anti', 'peak anti-Xa activity', 'Trough values and AUC', 'Pharmacokinetic profiles', 'Xa activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0206232', 'cui_str': 'Nadroparin'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1522438', 'cui_str': 'Subcutaneous route'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",60.0,0.230086,Xa activity was 0.38 IU/ml in the IV group vs 0.20 IU/ml in the SC group (p < 0.001).,"[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'De Schryver', 'Affiliation': 'Intensive Care Unit, Clinique Saint-Pierre, Ottignies, Belgium; Department of critical care medicine, Cliniques Universitaires St-Luc, Université catholique de Louvain, Brussels, Belgium. Electronic address: nicolas.deschryver@cspo.be.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Serck', 'Affiliation': 'Intensive Care Unit, Clinique Saint-Pierre, Ottignies, Belgium.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Eeckhoudt', 'Affiliation': 'Laboratory of Hematology, Laboratoire des Hôpitaux Universitaires de Bruxelles, LHUB-ULB, Brussels, Belgium.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Department of critical care medicine, Cliniques Universitaires St-Luc, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Department of critical care medicine, Cliniques Universitaires St-Luc, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Gérard', 'Affiliation': 'Department of critical care medicine, Cliniques Universitaires St-Luc, Université catholique de Louvain, Brussels, Belgium.'}]",Journal of critical care,['10.1016/j.jcrc.2022.154029']
688,35380053,Magnesium Sulfate and Hematoma Expansion: An Ancillary Analysis of the FAST-MAG Randomized Trial.,"BACKGROUND


Intracerebral hemorrhage (ICH) is the deadliest form of stroke. In observational studies, lower serum magnesium has been linked to more hematoma expansion (HE) and intracranial hemorrhage, implying that supplemental magnesium sulfate is a potential acute treatment for patients with ICH and could reduce HE. FAST-MAG (Field Administration of Stroke Therapy - Magnesium) was a clinical trial of magnesium sulfate started prehospital in patients with acute stroke within 2 hours of last known well enrolled. CT was not required prior to enrollment, and several hundred patients with acute ICH were enrolled. In this ancillary analysis, we assessed the effect of magnesium sulfate treatment upon HE in patients with acute ICH.
METHODS


We retrospectively analyzed data that were prospectively collected in the FAST-MAG study. Patients received intravenous magnesium sulfate or matched placebo within 2 hours of onset. We compared HE among patients allocated to intravenous magnesium sulfate or placebo with a Mann-Whitney  U . We used the same method to compare neurological deficit severity (National Institutes of Health Stroke Scale) and global disability (modified Rankin Scale) at 3 months.
RESULTS


Among 268 patients with ICH meeting study entry criteria, mean 65.4±13/4 years, 33% were female, and 211 (79%) had a history of hypertension. Initial deficit severities were median (interquartile range) of 4 (3-5) on the Los Angeles Motor Scale in the field and National Institutes of Health Stroke Scale score of 16 (9.5-25.5) early after hospital arrival. Follow-up brain imaging was performed a median of 17.1 (11.3-22.7) hours after first scan. The magnesium and placebo groups did not statistically differ in hematoma volume on arrival, 10.1 (5.6-28.7) versus 12.4 (5.6-28.7) mL ( P =0.6), or HE, 2.0 (0.1-7.4) versus 1.5 (-0.2 to 8) mL ( P =0.5). There was no difference in functional outcomes (modified Rankin Scale score of 3-6), 59% versus 50% ( P =0.5).
CONCLUSIONS


Magnesium sulfate did not reduce HE or improve functional outcomes at 90 days. A benefit for patients with initial hypomagnesemia was not addressed.
REGISTRATION


URL: https://www.
CLINICALTRIALS


gov; Unique identifier: NCT00059332.",2022,"There was no difference in functional outcomes (modified Rankin Scale score of 3-6), 59% versus 50% ( P =0.5).
","['268 patients with ICH meeting study entry criteria, mean 65.4±13/4 years, 33% were female, and 211 (79%) had a history of hypertension', 'patients with acute stroke within 2 hours of last known well enrolled', 'several hundred patients with acute ICH were enrolled', 'patients with acute ICH', 'patients with initial hypomagnesemia', 'patients with ICH and could reduce HE']","['Magnesium Sulfate and Hematoma Expansion', 'intravenous magnesium sulfate or matched placebo', 'FAST-MAG (Field Administration of Stroke Therapy - Magnesium', 'intravenous magnesium sulfate or placebo', 'CT', 'magnesium sulfate', 'magnesium and placebo', 'Magnesium sulfate']","['Initial deficit severities', 'hematoma volume', 'Stroke Scale score', 'functional outcomes', 'functional outcomes (modified Rankin Scale score', 'neurological deficit severity (National Institutes of Health Stroke Scale) and global disability (modified Rankin Scale']","[{'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0129439', 'cui_str': 'Myelin associate glycoprotein'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",268.0,0.210486,"There was no difference in functional outcomes (modified Rankin Scale score of 3-6), 59% versus 50% ( P =0.5).
","[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Naidech', 'Affiliation': 'Department of Neurology, Northwestern Medicine, Chicago, IL (A.M.N.).'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Shkirkova', 'Affiliation': 'Department of Neurology, University of California at Los Angeles (K.S., J.P.V., N.S., D.S.L., L.S., S.S., J.L.S.).'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Villablanca', 'Affiliation': 'Department of Neurology, University of California at Los Angeles (K.S., J.P.V., N.S., D.S.L., L.S., S.S., J.L.S.).'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'Department of Neurology, University of California at Los Angeles (K.S., J.P.V., N.S., D.S.L., L.S., S.S., J.L.S.).'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Department of Neurology, University of California at Los Angeles (K.S., J.P.V., N.S., D.S.L., L.S., S.S., J.L.S.).'}, {'ForeName': 'Latisha', 'Initials': 'L', 'LastName': 'Sharma', 'Affiliation': 'Department of Neurology, University of California at Los Angeles (K.S., J.P.V., N.S., D.S.L., L.S., S.S., J.L.S.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Eckstein', 'Affiliation': 'Department of Emergency Medicine, University of Southern California, Los Angeles (M.E.).'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Stratton', 'Affiliation': 'Department of Neurology, University of California at Los Angeles (K.S., J.P.V., N.S., D.S.L., L.S., S.S., J.L.S.).'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'National Institutes of Neurological Diseases and Stroke, Bethesda, MD (R.C.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Department of Neurology, Stanford University, Palo Alto, CA (S.H.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Department of Neurology, University of California at Los Angeles (K.S., J.P.V., N.S., D.S.L., L.S., S.S., J.L.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.037999']
689,35390172,"A Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Novel Insulin Dimer.","Insulin molecules of size much greater than natural insulin have been synthesized and studied with the intention of widening the therapeutic window between adequate glycemic control and hypoglycemia as compared with conventional insulins. MK-1092 is a synthetic insulin dimer with favorable properties demonstrated in preclinical studies. Here, we report the results of the first-in-human, randomized, double-blind, active-control, single ascending dose trial of MK-1092, conducted in healthy adults, adults with type 1 diabetes (T1D), and adults with type 2 diabetes (T2D). MK-1092 was well tolerated in all study populations, and no dose-related adverse events were identified across the evaluated dose range (4-64 nmol/kg). Circulating concentrations of MK-1092 were approximately dose-proportional. Maximum glucose infusion rate (GIR) and 24-hour time-weighted average GIR were evaluated under euglycemic clamp conditions. These pharmacodynamic measurements were approximately dose-proportional in all study populations; at similar doses, the GIR parameters were lower in adults with T2D than in healthy adults or adults with T1D, likely due to the influence of insulin resistance. At doses ≥ 16 nmol/kg, MK-1092 had similar or greater effects than glargine 3 nmol/kg (0.5 units/kg) on increasing GIR in each study population and on suppressing free fatty acids and ketone generation in adults with T1D. MK-1092 did not prevent a subsequent high dose of lispro from increasing the GIR in healthy adults. Additional studies in adults with T1D and T2D are needed to further evaluate the safety, tolerability, and efficacy profile of MK-1092 and its potential for differentiation from more conventional insulins. (ClinicalTrials.gov: NCT03170544).",2022,"These pharmacodynamic measurements were approximately dose-proportional in all study populations; at similar doses, the GIR parameters were lower in adults with T2D than in healthy adults or adults with T1D likely due to the influence of insulin resistance.","['healthy adults, adults with type 1 diabetes (T1D), and adults with type 2 diabetes (T2D', 'healthy adults', 'adults with T1D and T2D']","['MK-1092', 'glargine']","['Circulating concentrations of MK-1092', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'Maximum Glucose Infusion Rate (GIR) and 24h Time-Weighted Average GIR']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.121342,"These pharmacodynamic measurements were approximately dose-proportional in all study populations; at similar doses, the GIR parameters were lower in adults with T2D than in healthy adults or adults with T1D likely due to the influence of insulin resistance.","[{'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Walford', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Duncan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': 'ProSciento, Inc., Chula Vista, California, USA.'}, {'ForeName': 'Pavan', 'Initials': 'P', 'LastName': 'Vaddady', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hompesch', 'Affiliation': 'ProSciento, Inc., Chula Vista, California, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'ProSciento, Inc., Chula Vista, California, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2607']
690,35385504,A comparative assessment of two different front-of-package nutrition label designs: A randomized experiment in Brazil.,"This study compares the effectiveness of different front-of-package label designs in a Brazilian sample (n = 1384). Eligible adults were randomized to one of two study arms and viewed images of snacks with either a triangular warning label (TL) or a rectangular 'high in' label with a magnifying glass (ML). They responded to a series of questions that captured label usefulness, understanding, and purchase intentions. Compared to participants in the ML arm, those in the TL arm agreed that the TL communicated important information [Mean (SD) - 5.47 (0.07) vs 4.49 (0.08), p-value <0.001], was a useful tool [Mean (SD) - 6.12 (0.06) vs 5.75 (0.07), p-value <0.001], and was easier to understand as measured subjectively [Mean (SD) - 4.96 (0.07) vs 4.44 (0.08), p-value <0.001]. However, both the TL and the ML performed similarly in communicating nutrient information as measured by the objective understanding of nutrient content [57.09% vs 54.65%, p-value 0.259]. The ML performed marginally better at improving purchase intentions [Mean (SD) - 2.57 (0.07) vs 2.79 (0.08), p-value <0.049]. The current study adds to the growing evidence base on the pathways through which FoP labels, particularly 'high in' labels, might influence consumer perceptions and behavior. It is also one of the first studies to provide evidence on the utility of the ML design for Brazil.",2022,"However, both the TL and the ML performed similarly in communicating nutrient information as measured by the objective understanding of nutrient content [57.09% vs 54.65%, p-value 0.259].","['Eligible adults', 'a Brazilian sample (n = 1384']","[""viewed images of snacks with either a triangular warning label (TL) or a rectangular 'high in' label with a magnifying glass (ML""]","['purchase intentions', 'objective understanding of nutrient content']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0205142', 'cui_str': 'Rectangular'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",1384.0,0.146608,"However, both the TL and the ML performed similarly in communicating nutrient information as measured by the objective understanding of nutrient content [57.09% vs 54.65%, p-value 0.259].","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Khandpur', 'Affiliation': 'Faculty of Public Health (FSP), Department of Nutrition, Department of Nutrition, Center for Epidemiological Studies in Health and Nutrition (Nupens), University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Laís', 'Initials': 'L', 'LastName': 'Amaral Mais', 'Affiliation': 'Brazilian Institute for Consumer Defense (Idec), São Paulo, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Bortoletto Martins', 'Affiliation': 'Faculty of Public Health (FSP), Department of Nutrition, Department of Nutrition, Center for Epidemiological Studies in Health and Nutrition (Nupens), University of São Paulo (USP), São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0265990']
691,35395598,The feasibility and efficacy of the home-based exercise programs in patients with cognitive impairment: A pilot study.,"OBJECTIVE


To examine the feasibility and efficacy of home-based aerobic and resistance exercise interventions for geriatric individuals with cognitive impairment.
METHODS


Fourteen participants with cognitive impairment were allocated to either the aerobic group (n = 8) or the resistance group (n = 6), after which they implemented a two-month home-based training program. Feasibility and efficacy outcomes were evaluated. A semi-structured interview was performed after the intervention.
RESULTS


All fourteen participants completed the two-month training program. The adherence rate was 0.94 for the aerobic group and 0.96 for the resistance group. No adverse events occurred. The results revealed a trend of group×time interaction effect on delayed recall. Significant group×time interaction effects were revealed on simple physical performance and body composition. Semi-structured interviews identified four motivators for participating in this program, four facilitators for and three barriers to keeping exercising, and some perceived benefits.
CONCLUSION


Home-based aerobic and resistance exercise programs are feasible for geriatric individuals with cognitive impairment. The efficacy needs to be further examined.",2022,No adverse events occurred.,"['patients with cognitive impairment', 'Fourteen participants with cognitive impairment', 'geriatric individuals with cognitive impairment']","['aerobic group (n\xa0=\xa08) or the resistance group (n\xa0=\xa06), after which they implemented a two-month home-based training program', 'home-based exercise programs', 'home-based aerobic and resistance exercise interventions', 'Home-based aerobic and resistance exercise programs']","['Feasibility and efficacy outcomes', 'simple physical performance and body composition', 'adherence rate', 'feasibility and efficacy', 'group×time interaction effect on delayed recall']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",14.0,0.0102898,No adverse events occurred.,"[{'ForeName': 'Xiuxiu', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai-dian district, Beijing 100191, China.'}, {'ForeName': 'Shifang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai-dian district, Beijing 100191, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai-dian district, Beijing 100191, China; Department of Neurology, Peking University First Hospital, 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai-dian district, Beijing 100191, China.'}, {'ForeName': 'Jiaqiong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Peking University First Hospital, 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Cao', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai-dian district, Beijing 100191, China.'}, {'ForeName': 'Qiaoqin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai-dian district, Beijing 100191, China. Electronic address: qqwan05@163.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.03.010']
692,35396728,Estimation of vaccine efficacy for variants that emerge after the placebo group is vaccinated.,"SARS-CoV-2 continues to evolve and the vaccine efficacy against variants is challenging to estimate. It is now common in phase III vaccine trials to provide vaccine to those randomized to placebo once efficacy has been demonstrated, precluding a direct assessment of placebo controlled vaccine efficacy after placebo vaccination. In this work, we extend methods developed for estimating vaccine efficacy post placebo vaccination to allow variant specific time varying vaccine efficacy, where time is measured since vaccination. The key idea is to infer counterfactual strain specific placebo case counts by using surveillance data that provide the proportions of the different strains. This blending of clinical trial and observational data allows estimation of strain-specific time varying vaccine efficacy, or sieve effects, including for strains that emerge after placebo vaccination. The key requirements are that the surveillance strain distribution accurately reflects the strain distribution for a placebo group throughout follow-up after placebo group vaccination, and that at least one strain is present before and after placebo vaccination. For illustration, we develop a Poisson approach for an idealized design under a rare disease assumption and then use a proportional hazards model to address staggered entry, staggered crossover, and smoothly varying strain specific vaccine efficacy. We evaluate these methods by theoretical work and simulations, and demonstrate that useful estimation of the efficacy profile is possible for strains that emerge after vaccination of the placebo group. An important principle is to incorporate sensitivity analyses to guard against misspecification of the strain distribution.",2022,"We evaluate these methods by theoretical work and simulations, and demonstrate that useful estimation of the efficacy profile is possible for strains that emerge after vaccination of the placebo group.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.585901,"We evaluate these methods by theoretical work and simulations, and demonstrate that useful estimation of the efficacy profile is possible for strains that emerge after vaccination of the placebo group.","[{'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Follmann', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Disease, Bethesda, Maryland, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fay', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Disease, Bethesda, Maryland, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Magaret', 'Affiliation': 'Vaccines and Infectious Diseases Division, Fred Hutch Cancer Research Center, Seattle, Washington, USA.'}]",Statistics in medicine,['10.1002/sim.9405']
693,35397250,Reducing public stigma toward individuals with psychosis across race and gender: A randomized controlled trial of young adults.,"BACKGROUND


Social contact-based interventions effectively reduce stigma toward psychosis. We recently demonstrated the efficacy of a 90-second video intervention in reducing stigma. The current randomized controlled study presents four briefer videos differing in presenter's gender/race, with baseline, postintervention, and 30-day follow-up assessments. The study replicates previous findings and examine whether concordance of presenter's and viewer's race/gender enhanced the anti-stigma effect.
METHODS


Using a crowdsourcing platform, we recruited 1993 participants ages 18-35 years to one of four brief video-based interventions (Black/White female, Black/White male presenters) or a nonintervention control condition. In the videos, a young presenter with psychosis humanized their illness through an evocative description of living a meaningful and productive life.
RESULTS


Group-by-time ANOVA showed a significant group-by-time interaction for the total score of all five stigma domains: social distance, stereotyping, separateness, social restriction, and perceived recovery. One-way ANOVA showed greater reductions in video intervention groups than control at post-intervention and 30-day follow-up, but no differences between video groups. Matching race/gender did not further reduce stigma.
CONCLUSIONS


This randomized controlled study replicated and extended previous research findings, by showing stigma reduction across videos that differ in the presenter's gender and race, thus enhancing generalizability. The videos described the experience of psychosis and reduced stigma, suggesting their potential utility on social media platforms to increase the likelihood of seeking services and ultimately may improve access to care among young individuals with psychosis. Future research should address intersectional stigma experiences by focusing on race/gender and culturally tailoring the narrative.",2022,"One-way ANOVA showed greater reductions in video intervention groups than control at post-intervention and 30-day follow-up, but no differences between video groups.","['1993 participants ages 18-35\xa0years to one of four brief video-based interventions (Black/White female, Black/White male presenters) or a', 'young adults', 'individuals with psychosis across race and gender', 'young individuals with psychosis']","['90-second video intervention', 'nonintervention control condition']","['public stigma', 'total score of all five stigma domains: social distance, stereotyping, separateness, social restriction, and perceived recovery']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",1993.0,0.07256,"One-way ANOVA showed greater reductions in video intervention groups than control at post-intervention and 30-day follow-up, but no differences between video groups.","[{'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Amsalem', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America. Electronic address: doron.amsalem@nyspi.columbia.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Valeri', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, United States of America.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Jankowski', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Yang', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York, NY, United States of America; Department of Epidemiology, Mailman School of Public Health, New York, NY, United States of America.'}, {'ForeName': 'Iruma', 'Initials': 'I', 'LastName': 'Bello', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Nossel', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Malinovsky', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ngo', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Lieff', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York, NY, United States of America.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Pagdon', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lipp', 'Affiliation': 'Department of Human Ecology, University of California, Davis, United States of America.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Markowitz', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Neria', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America; Department of Epidemiology, Columbia University Irving Medical Center, United States of America.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Dixon', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2022.03.011']
694,35397249,The effect on relapse rate and psychiatric symptomatology: Switching a combination of first- and second-generation antipsychotic polypharmacy to antipsychotic monotherapy in long-term inpatients with schizophrenia and related disorders. A pragmatic randomized open-label trial (SwAP trial).,"BACKGROUND


There is little evidence to support the use of antipsychotic polypharmacy, and there are concerns about safety and side effects. Nonetheless, it is commonly used in the treatment of long-term inpatients with schizophrenia. This study investigated the effects of switching from a combination of first- and second-generation antipsychotics (FGA and SGA) to monotherapy (FGA or SGA) on relapse rates and psychiatric symptomatology.
METHODS


Institutionalized patients with chronic psychotic disorders using a combination of SGA and FGA (n = 136) participated in a randomized open-label trial. The SWITCH group discontinued either FGA or SGA, the STAY group continued combination treatment. Relapse and psychotic symptoms were measured at baseline and during follow-up at 3, 6, and 9 months. Psychiatric symptomatology was measured using the Brief Psychiatric Rating Scale (BPRS). Relapse was defined as (i) an increase in BPRS score of at least 2 points on any item, or (ii) an increase of at least 4 points in total BPRS score and an adjustment of antipsychotics.
RESULTS


A logistic regression model, corrected for sex, showed that the probability of relapse was significantly lower in the SWITCH group: 0.29 (95% CI 0.13-0.62). The protective effect of switching to monotherapy was attributable to patients continuing clozapine as monotherapy. For patients who did not experience a relapse nor dropped out, BPRS total scores decreased significantly more in the SWITCH group (p = 0.0001).
CONCLUSION


Switching from a combination of FGA and SGA to monotherapy in long-term inpatients does not increase the relapse rate and may even reduce it.",2022,"For patients who did not experience a relapse nor dropped out, BPRS total scores decreased significantly more in the SWITCH group (p = 0.0001).
","['long-term inpatients with schizophrenia', 'Institutionalized patients with chronic psychotic disorders using a combination of SGA and FGA (n\xa0=\xa0136', 'long-term inpatients with schizophrenia and related disorders']","['first- and second-generation antipsychotics (FGA and SGA) to monotherapy (FGA or SGA', 'FGA or SGA', 'first- and second-generation antipsychotic polypharmacy to antipsychotic monotherapy', 'clozapine']","['BPRS score', 'relapse rates and psychiatric symptomatology', 'Relapse and psychotic symptoms', 'BPRS total scores', 'relapse rate', 'probability of relapse', 'relapse rate and psychiatric symptomatology', 'Brief Psychiatric Rating Scale (BPRS', 'Psychiatric symptomatology', 'total BPRS score', 'Relapse']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0009079', 'cui_str': 'Clozapine'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",136.0,0.0329855,"For patients who did not experience a relapse nor dropped out, BPRS total scores decreased significantly more in the SWITCH group (p = 0.0001).
","[{'ForeName': 'Mushde', 'Initials': 'M', 'LastName': 'Shakir', 'Affiliation': 'Veldzicht Center for Transcultural Psychiatry, Custodial Institutions Agency (DJI), Ministry of Justice and Security, Balkbrug, the Netherlands; i-psy Haaglanden, Parnassia Group Mental Health Service, Den Haag, the Netherlands; Maastricht University, Faculty of Health, Medicine and Life Sciences, School for Mental Health and Neuroscience, Maastricht, the Netherlands. Electronic address: mujde_mahmud@hotmail.com.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Willems', 'Affiliation': 'Maastricht University, Faculty of Health, Medicine and Life Sciences, School for Mental Health and Neuroscience, Maastricht, the Netherlands; Psychiatric Center GGz Centraal, Amersfoort, the Netherlands.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'van Harten', 'Affiliation': 'Maastricht University, Faculty of Health, Medicine and Life Sciences, School for Mental Health and Neuroscience, Maastricht, the Netherlands; Psychiatric Center GGz Centraal, Amersfoort, the Netherlands.'}, {'ForeName': 'Remko', 'Initials': 'R', 'LastName': 'van Lutterveld', 'Affiliation': 'Brain Research and Innovation Center, Ministry of Defence, Utrecht, the Netherlands; University Medical Center Utrecht, Department of Psychiatry, Utrecht, the Netherlands.'}, {'ForeName': 'Diederik E', 'Initials': 'DE', 'LastName': 'Tenback', 'Affiliation': 'Veldzicht Center for Transcultural Psychiatry, Custodial Institutions Agency (DJI), Ministry of Justice and Security, Balkbrug, the Netherlands; FPC de Oostvaarderskliniek, Custodial Institutions Agency (DJI), Ministry of Justice and Security, Almere, the Netherlands.'}]",Schizophrenia research,['10.1016/j.schres.2022.03.008']
695,35347091,Transcutaneous Electrical Acustimulation Improves Constipation by Enhancing Rectal Sensation in Patients With Functional Constipation and Lack of Rectal Sensation.,"INTRODUCTION


Reduced rectal sensation is involved in the pathophysiology of constipation. The aim of this study was to investigate the effects of transcutaneous electrical acustimulation (TEA) at acupuncture point ST36 on constipation and rectal sensation as well as autonomic functions in patients with constipation and reduced rectal sensation.
METHODS


In an acute study, anorectal motility and sensation tests were performed in constipation patients (N = 53) who were treated with TEA at ST36 or sham points. In a chronic study, patients (N = 18) underwent 2 weeks of TEA or sham-TEA in a crossover design.
RESULTS


Chronic TEA increased spontaneous bowel movements (3.72 vs 2.00 per week with sham-TEA, P < 0.0001) and significantly reduced constipation symptoms and increased quality of life in comparison with sham-TEA (P < 0.05). Acute TEA reduced the sensation threshold in response to rectal distention for the urge of defecation and maximum tolerable volume (P < 0.05, vs baseline); chronic TEA reduced the sensation thresholds for first sensation and desire of defecation, and decreased the threshold volume to an elicit rectal anal inhibitory reflex (P < 0.05). Both acute and chronic TEA increased parasympathetic activity (P < 0.05).
DISCUSSION


TEA at ST36 improves chronic constipation by enhancing rectal sensation possibly mediated by the reinforcement of parasympathetic activity in patients with functional constipation and reported lack/absence of rectal sensation.",2022,"Both acute and chronic TEA increased parasympathetic activity (P＜0.05).
","['patients with functional constipation', 'patients with constipation and reduced rectal sensation', 'Patients with Functional Constipation and Lack of Rectal Sensation', 'constipation patients (N = 53) who were treated with']","['acupuncture point ST36', 'Transcutaneous Electrical Acustimulation', 'TEA at ST36', 'TEA or sham-TEA', 'transcutaneous electrical acustimulation (TEA']","['anorectal motility and sensation tests', 'spontaneous bowel movements', 'parasympathetic activity', 'constipation and rectal sensation', 'constipation symptoms and increased quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0232717', 'cui_str': 'Rectal sensation'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0232718', 'cui_str': 'Anorectal motility'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0232717', 'cui_str': 'Rectal sensation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",53.0,0.0890083,"Both acute and chronic TEA increased parasympathetic activity (P＜0.05).
","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Division of Gastroenterology, Yinzhou Hospital Affiliated to Medical School of Ningbo, University, Ningbo, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jiande D Z', 'Initials': 'JDZ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000485']
696,35351048,Iconic Therapy for the reduction of borderline personality disorder symptoms among suicidal youth: a preliminary study.,"BACKGROUND


Iconic therapy (IT) is a new therapy that uses images to teach skills with the aim of improving the symptoms of borderline personality disorder. Preliminary results are promising, and there is indication that IT may be effective. The purpose of this preliminary study was to test the effectiveness of IT compared to a psychological supportive intervention (SI).
METHODS


The study was carried out at the University Regional Hospital of Malaga. Young patients (N = 40; 15-30 years) with suicidal or parasuicidal behavior and borderline personality traits were randomized into IT (N = 20) or SI (N = 20). The main outcome variable was a change in the symptoms of borderline personality disorder (BSL-23) at the end of treatment. The secondary outcome variables were suicidal ideation and behavior, self-harm, the need for medication, the number of visits to mental health professionals, maladaptive behavior, satisfaction with therapy and perceived improvement, both at the end of the intensive treatment and at the 12-month follow-up.
RESULTS


As expected, the two therapies produced a reduction in BPD symptoms at 10 weeks post-treatment and at the 12-month follow-up. Contrary to expectation, there were no statistically significant differences in the effectiveness of the two therapies (p > 0.05). However, at the 12-month follow-up, the effect sizes for the difference between the effectiveness of the two therapy groups on BSL-23 scores (d = 0.33) and on maladjustment to daily life (d = 0.39) was found to exceed the commonly used convention for a small effect (d = 0.20). Besides, participants in the IT group showed greater satisfaction with therapy than those who received SI. The mean difference between groups was statistically significant after the 10-week treatment period (p < .01), with a large effect size (d = 1.11). Nevertheless, this difference was not maintained at the 12-month follow-up (p > .05), although the effect size for this analysis (d = 0.34) was found to exceed a small effect.
CONCLUSIONS


This preliminary study did not find a statistically significant difference in the effectiveness of the two therapies, probably due to the small sample of participants, but there are some indicators (effect sizes) suggesting that perhaps IT may be superior for reducing BPD symptoms and maladjustment in daily life. Future studies with larger samples and comparisons with established treatments for borderline personality disorder are necessary to confirm that IT effects are significant and persistent in the long term.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03011190 . First posted 05/01/2017. Last update posted 15/05/2018.",2022,"Contrary to expectation, there were no statistically significant differences in the effectiveness of the two therapies (p > 0.05).","['University Regional Hospital of Malaga', 'borderline personality disorder symptoms among suicidal youth', 'Young patients (N\xa0=\u200940; 15-30\u2009years) with suicidal or parasuicidal behavior and borderline personality traits']","['psychological supportive intervention (SI', 'SI', 'Iconic Therapy', 'Iconic therapy (IT']","['satisfaction', 'suicidal ideation and behavior, self-harm, the need for medication, the number of visits to mental health professionals, maladaptive behavior, satisfaction with therapy and perceived improvement, both at the end of the intensive treatment', 'BSL-23 scores', 'symptoms of borderline personality disorder (BSL-23', 'BPD symptoms', 'maladjustment to daily life']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0562443', 'cui_str': 'Maladaptive behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1443933', 'cui_str': 'Laboratory biosafety level'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0037423', 'cui_str': 'Social maladjustment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.0498146,"Contrary to expectation, there were no statistically significant differences in the effectiveness of the two therapies (p > 0.05).","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Hurtado-Santiago', 'Affiliation': 'San Juan de Dios Psychiatric Centre, Málaga, Spain. shs@cop.es.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guzmán-Parra', 'Affiliation': 'University Regional Hospital of Málaga. Mental Health Unit. Biomedical Research Institute of Málaga (IBIMA, Málaga, Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Mayoral', 'Affiliation': 'University Regional Hospital of Málaga. Mental Health Unit. Biomedical Research Institute of Málaga (IBIMA, Málaga, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Bersabé', 'Affiliation': 'Psychobiology and Methodology of the Behavioral Sciences Department, University of Málaga, Málaga, Spain.'}]",BMC psychiatry,['10.1186/s12888-022-03862-x']
697,35351037,A clinical trial of cognitive behavior therapy for psychiatric comorbidity and quality of life with Cancer Patients during Chemotherapy (CPdC).,"BACKGROUND


Cancer is a common worldwide illness; it evokes psychological distress at different stages, during chemotherapy patient perceives a variety of psychiatric symptoms due to various medication side-effects and psychological distress. Studies have shown a significant impact of cognitive behavior therapy (CBT) in the management of psychiatric symptoms during chemotherapy. This study aims to investigate the effectiveness of CBT for depression, anxiety, stress, death anxiety, satisfaction with life, and self-esteem among cancer patients during chemotherapy (CPdC).
METHODS


Place and duration of the study: Department of Applied Psychology, Government College University Faisalabad in collaboration with Department of Oncology, Allied Hospital Faisalabad from November 20, 2020 and July 31, 2021. A total of 90 cancer patients were enrolled. 70 out of 90 met the eligibility criteria and 60 participants fulfilled all requirements. Participants were randomly allocated to four different groups. The pre-assessment screening was started along with the first trial of chemotherapy. The CBT-based treatment plan was formulated and one session per week was given to each patient for 3 to 4 months. Participants' age range was 18-65 years (M ± SD = 47.51 ± 12.36. Demographic form, Depression Anxiety and Stress Scale (DASS), Death Anxiety Scale (DAS), Satisfaction with Life Scale (SWLS), and Rosenberg Self-Esteem Scale (RSES) were administered. Descriptive, t-test, and repeated measure ANOVA statistics were used to investigate the findings.
RESULTS


Results indicated significant mean difference on the variable of depression, anxiety and stress across four conditions (i.e. F(2, 56) = 39.55, p < .000, η 2  = .679; F(2,56) = 73.32, p < .000, η 2  = .797; F(2,56) = 119.77, p < .000, η 2  = .865 respectively). On death anxiety significant difference across four conditions was found (F(2,56) = 22.71, p < .000, η 2  = .549) with large effect size. Furthermore, findings indicated significant mean difference on the variable of satisfaction with life and self-esteem across four conditions was found (F(2,56) = 22.05, p < .000, η 2  = .542; F(2,56) = 36.19, p < .000, η 2  = .660) with large effect size.
CONCLUSION


It is concluded that CBT played a very effective role to reduce depression, anxiety, and stress-related psychiatric symptoms. CBT reduces the level of death anxiety and improving the quality of life and level of self-esteem among CPdC.
TRIAL REGISTRATION


The study trial was registered in the Thai Clinical Trial Registry-TCTR ( TCTR20201113002 ).",2022,"CBT reduces the level of death anxiety and improving the quality of life and level of self-esteem among CPdC.
TRIAL REGISTRATION


","['70 out of 90 met the eligibility criteria and 60 participants fulfilled all requirements', ""Participants' age range was 18-65\u2009years (M\u2009±\u2009SD\u2009=\u200947.51\u2009±\u200912.36"", 'cancer patients during chemotherapy (CPdC', 'with Cancer Patients during Chemotherapy (CPdC', 'Place and duration of the study: Department of Applied Psychology, Government College University Faisalabad in collaboration with Department of Oncology, Allied Hospital Faisalabad from November 20, 2020 and July 31, 2021', '90 cancer patients were enrolled']","['CBT', 'cognitive behavior therapy', 'cognitive behavior therapy (CBT']","['quality of life and level of self-esteem', 'variable of depression, anxiety and stress', 'depression, anxiety, stress, death anxiety, satisfaction with life, and self-esteem', 'Demographic form, Depression Anxiety and Stress Scale (DASS), Death Anxiety Scale (DAS), Satisfaction with Life Scale (SWLS), and Rosenberg Self-Esteem Scale (RSES', 'satisfaction with life and self-esteem', 'level of death anxiety', 'psychiatric comorbidity and quality of life', 'depression, anxiety, and stress-related psychiatric symptoms']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033911', 'cui_str': 'Applied Psychology'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0522179', 'cui_str': 'Death anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]",90.0,0.161966,"CBT reduces the level of death anxiety and improving the quality of life and level of self-esteem among CPdC.
TRIAL REGISTRATION


","[{'ForeName': 'Qasir', 'Initials': 'Q', 'LastName': 'Abbas', 'Affiliation': 'Department of Applied Psychology, Government College University Faisalabad, Zakid Block 1st floor, Main Campus, Faisalabad, Punjab, Pakistan. qasirabbas47@yahoo.com.'}, {'ForeName': 'Nimra', 'Initials': 'N', 'LastName': 'Arooj', 'Affiliation': 'Department of Applied Psychology, Government College University Faisalabad, Zakid Block 1st floor, Main Campus, Faisalabad, Punjab, Pakistan.'}, {'ForeName': 'Khawer Bilal', 'Initials': 'KB', 'LastName': 'Baig', 'Affiliation': 'Department of Professional Psychology, Bahria University Lahore Campus, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Umar', 'Initials': 'MU', 'LastName': 'Khan', 'Affiliation': 'Department of Applied Psychology, Government College University Faisalabad, Zakid Block 1st floor, Main Campus, Faisalabad, Punjab, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Khalid', 'Affiliation': 'Department of Clinical Oncology, Medical University Faisalabad, Faisalabad, Punjab, Pakistan.'}, {'ForeName': 'Mafia', 'Initials': 'M', 'LastName': 'Shahzadi', 'Affiliation': 'Department of Applied Psychology, Government College University Faisalabad, Zakid Block 1st floor, Main Campus, Faisalabad, Punjab, Pakistan.'}]",BMC psychiatry,['10.1186/s12888-022-03863-w']
698,35377244,"UC-II Undenatured Type II Collagen for Knee Joint Flexibility: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study.","Objective:  Joint-related stress models have been used in the past to induce a standardized load on physical structures, allowing researchers to observe changes in perceived stress on joints as accurately as possible in healthy individuals. Previous studies support the efficacy of UC-II ®  undenatured type II collagen (""undenatured collagen"") supplementation in maintaining joint health. The purpose of this study was to assess the effect of undenatured collagen on knee flexibility in healthy subjects who experience activity-related joint discomfort (ArJD).  Methods:  This randomized, double-blind, placebo (PLA)-controlled study was conducted in healthy subjects with ArJD who had no history of osteoarthritis, or joint diseases. Ninety-six ( n  = 96, 20-55 years old) subjects who reported joint discomfort while performing a standardized single-leg-step-down test were randomized to receive either PLA ( n  = 48) or 40 mg of undenatured collagen ( n  = 48) supplementation daily for 24 weeks. Range of motion (ROM) flexion and extension were measured using a digital goniometer.  Results:  At the end of the study, a statistically significant increase in knee ROM flexion was observed in the undenatured collagen group versus the PLA group (3.23° vs. 0.21°;  p  = 0.025). In addition, an increase in knee ROM extension by 2.21° was observed over time in the undenatured collagen group ( p  = 0.0061), while the PLA group showed a nonsignificant increase by 1.27° ( p  > 0.05). Subgroup analysis by age showed a significant increase in knee ROM flexion in subjects >35 years old in the undenatured collagen supplemented group compared with PLA (6.79° vs. 0.30°;  p  = 0.0092).  Conclusion:  Overall, these results suggest that daily supplementation of 40 mg of undenatured collagen improved knee joint ROM flexibility and extensibility in healthy subjects with ArJD.",2022,Subgroup analysis by age showed a significant increase in knee ROM flexion in subjects >35 years old in the undenatured collagen supplemented group compared with PLA (6.79° vs. 0.30°;  p  = 0.0092).  ,"['Knee Joint Flexibility', 'healthy subjects with ArJD', 'healthy individuals', 'healthy subjects who experience activity-related joint discomfort (ArJD', 'healthy subjects with ArJD who had no history of osteoarthritis, or joint diseases', '96, 20-55 years old) subjects who reported joint discomfort while performing a standardized single-leg-step-down test', 'Ninety-six ( n \u2009']","['PLA ( n \u2009=\u200948) or 40\u2009mg of undenatured collagen ( n \u2009=\u200948) supplementation daily for 24 weeks', 'PLA', 'Placebo', 'UC-II Undenatured Type II Collagen', 'placebo (PLA)-controlled', 'undenatured collagen', 'UC-II ®  undenatured type II collagen (""undenatured collagen"") supplementation']","['knee flexibility', 'Range of motion (ROM) flexion and extension', 'knee joint ROM flexibility and extensibility', 'knee ROM flexion', 'knee ROM extension']","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009331', 'cui_str': 'Collagen type II'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}]",96.0,0.0717375,Subgroup analysis by age showed a significant increase in knee ROM flexion in subjects >35 years old in the undenatured collagen supplemented group compared with PLA (6.79° vs. 0.30°;  p  = 0.0092).  ,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Schön', 'Affiliation': 'Nutritional CRO, BioTeSys GmbH, Esslingen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Knaub', 'Affiliation': 'Nutritional CRO, BioTeSys GmbH, Esslingen, Germany.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Alt', 'Affiliation': 'Institute of Sports Science and Kinesiology, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Durkee', 'Affiliation': 'Research and Development, Lonza Greenwood, North Emerald Road, Greenwood, SC, USA.'}, {'ForeName': 'Zainulabedin', 'Initials': 'Z', 'LastName': 'Saiyed', 'Affiliation': 'Research and Development, Lonza Greenwood, North Emerald Road, Greenwood, SC, USA.'}, {'ForeName': 'Vijaya', 'Initials': 'V', 'LastName': 'Juturu', 'Affiliation': 'Research and Development, Lonza Greenwood, North Emerald Road, Greenwood, SC, USA.'}]",Journal of integrative and complementary medicine,['10.1089/jicm.2021.0365']
699,35363821,Does exercise influence burn-induced inflammation: A cross-over randomised controlled feasibility trial.,"BACKGROUND


Burn injuries trigger a greater and more persistent inflammatory response than other trauma cases. Exercise has been shown to positively influence inflammation in healthy and diseased populations, however little is known about the latent effect of exercise on chronic inflammation in burn injured patients. The aims of the pilot study were to assess the feasibility of implementing a long duration exercise training program, in burn injured individuals including learnings associated with conducting a clinical trial in COVID-19 pandemic.
METHODS


Fifteen participants with a burn injury between 5-20% total body surface area acquired greater than a year ago were randomised in a within-subject designed study, into one of two conditions, exercise-control or control-exercise. The exercise condition consisted of six weeks of resistance and cardiovascular exercises, completed remotely or supervised in a hospital gym. A comprehensive outcome measurement was completed at the initial, mid and end point of each exercise and control condition. To determine the success of implementation, the feasibility indicator for the data completeness across the comprehensive outcome battery was set at 80%.
RESULTS


Half (49%) of eligible participants in the timeframe, were recruited and commenced the study. Six participants withdrew prior to completion and a total of 15 participants completed the study. Eight participants were randomised to the exercise-control and seven to the control exercise group. Five participants trained remotely and seven did supervised training. Three participants completed a mix of both supervised and remote training initiated due to COVID restrictions. Outcome measures were completed on 97% of protocolised occasions and 100% of participants completed the exercise training.
CONCLUSIONS


Conducting a long duration exercise training study on burn injured individuals is feasible using the described methods. The knowledge gained helps improve the methodology in larger-scale projects. Insights into the impact of COVID-19 on this clinical trial and success enhancing adaptations for the researcher, research practice and the participant, are presented.",2022,"The aims of the pilot study were to assess the feasibility of implementing a long duration exercise training program, in burn injured individuals including learnings associated with conducting a clinical trial in COVID-19 pandemic.
","['Fifteen participants with a burn injury between 5-20% total body surface area acquired greater than a year ago', 'burn injured individuals including learnings associated with conducting a clinical trial in COVID-19 pandemic', 'Six participants withdrew prior to completion and a total of 15 participants completed the study', 'burn injured patients']","['exercise-control or control-exercise', 'implementing a long duration exercise training program', 'exercise-control and seven to the control exercise group', 'resistance and cardiovascular exercises, completed remotely or supervised in a hospital gym']",[],"[{'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003023', 'cui_str': 'Angola'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],8.0,0.0364342,"The aims of the pilot study were to assess the feasibility of implementing a long duration exercise training program, in burn injured individuals including learnings associated with conducting a clinical trial in COVID-19 pandemic.
","[{'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Rowe', 'Affiliation': 'Fiona Wood Foundation, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Edgar', 'Affiliation': 'Fiona Wood Foundation, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Osborne', 'Affiliation': 'Disciple of Exercise Physiology, Murdoch University, Murdoch, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fear', 'Affiliation': 'Burn Injury Research Unit, University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Wood', 'Affiliation': 'Fiona Wood Foundation, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Kenworthy', 'Affiliation': 'Fiona Wood Foundation, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0266400']
700,35384091,"Editorial Comment to Safety and efficacy of apalutamide in Japanese patients with metastatic castration-sensitive prostate cancer receiving androgen deprivation therapy: Final report for the Japanese subpopulation analysis of the randomized, placebo-controlled, phase III TITAN study.",,2022,,['Japanese patients with metastatic castration-sensitive prostate cancer receiving'],"['apalutamide', 'androgen deprivation therapy', 'placebo']",[],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.220062,,"[{'ForeName': 'Zhijiang', 'Initials': 'Z', 'LastName': 'Zang', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Ziting', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Chiong', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14891']
701,35385542,Maternal and child health handbook to improve continuum of maternal and child care in rural Bangladesh: Findings of a cluster randomized controlled trial.,"This study aimed to evaluate the effectiveness of maternal and child health handbook (MCH) enhanced by mobile tools and to generate evidence informing the adoption of the program in Bangladesh. A cluster randomized controlled trial (RCT) has been implemented in Lohagora of Narail District and Dhamrai of Dhaka District. Unions of the study settings were randomly allocated in either one of three groups: (1) Intervention 1 using both mobile platform and MCH, (2) Intervention 2 using MCH alone, or (3) the Control. A total of 3,002 participants were recruited. The interventions were designed to promote two-way communications between pregnant women/their families and community health workers by an empowering approach. A total of 3,002 pregnant women were recruited. As the results, the interventions both significantly improved the utilization of CoC, although the overall proportion of CoC was relevantly low: 2.79% in the Control (95% CI: 1.37-3.54%), 6.16% in Intervention 2 (95% CI: 4.67-7.86%), and 7.89% in Intervention 1 (95% CI: 6.29-9.90%). Neonatal mortality rate with and without CoC was 5.43 per 1,000 (95% CI: 3.63-9.57 per 1,000) and 34.8 per 1,000 (95% CI: 24.3-45.4 per 1,000), respectively. Our study indicated the effectiveness of the interventions by leveraging MCH and a mobile platform to promote uptake of CoC throughout prepartum, intrapartum and postpartum/neonatal periods, potentially bringing long-lasting benefits to mothers and their offspring. The explicit approach is expected to guide policy makers to adopt MCH interventions in primary healthcare strengthening at the community level. Trial registration: UMIN000025628 Registered June 13, 2016.",2022,"Neonatal mortality rate with and without CoC was 5.43 per 1,000 (95% CI: 3.63-9.57 per 1,000) and 34.8 per 1,000 (95% CI: 24.3-45.4 per 1,000), respectively.","['3,002 pregnant women were recruited', 'pregnant women/their families and community health workers by an empowering approach', 'A total of 3,002 participants were recruited', 'rural Bangladesh']","['maternal and child health handbook (MCH', 'Intervention 1 using both mobile platform and MCH, (2) Intervention 2 using MCH alone, or (3) the Control']","['overall proportion of CoC', 'utilization of CoC', 'Neonatal mortality rate']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",3002.0,0.132835,"Neonatal mortality rate with and without CoC was 5.43 per 1,000 (95% CI: 3.63-9.57 per 1,000) and 34.8 per 1,000 (95% CI: 24.3-45.4 per 1,000), respectively.","[{'ForeName': 'Ruoyan', 'Initials': 'R', 'LastName': 'Gai Tobe', 'Affiliation': 'Department of Social Security Empirical Research, National Institute of Population and Social Security Research, Tokyo, Japan.'}, {'ForeName': 'Syed Emdadul', 'Initials': 'SE', 'LastName': 'Haque', 'Affiliation': 'UChicago Research Bangladesh (URB), Dhaka, Bangladesh.'}, {'ForeName': 'Sanzida', 'Initials': 'S', 'LastName': 'Mubassara', 'Affiliation': 'Department of Botany, Faculty of Biological Sciences, Jahangirnagar University, Dhaka, Bangladesh.'}, {'ForeName': 'Rushdana', 'Initials': 'R', 'LastName': 'Rahman', 'Affiliation': 'Department of Obstetrics & Gynecology, Dhaka Medical College Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Ikegami', 'Affiliation': 'School of Tropical Medicine and Global Health, Nagasaki University NCGM Satellite, Tokyo, Japan.'}, {'ForeName': 'Rintaro', 'Initials': 'R', 'LastName': 'Mori', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",PloS one,['10.1371/journal.pone.0266074']
702,35387762,Effectiveness and Cost-effectiveness of Online Brief Mindfulness-based Cognitive Therapy for the Improvement of Productivity in the Workplace: Study Protocol for a Randomized Controlled Trial.,"BACKGROUND


Numerous studies have demonstrated the effectiveness of mindfulness-based programs (MBPs) among both clinical and nonclinical populations. These data document positive impacts in the workplace, including reducing perceived stress and burnout and increasing well-being. However, the effectiveness for productivity, which is of most interest to managers and administrators, is still unclear. In addition, MBPs in the workplace tend to be modified by reducing the number of the program sessions or delivering content online to improve accessibility. To date, however, the impact of MBPs that feature these modifications on productivity in the workplace has not been investigated.
OBJECTIVE


The study aims to investigate the effectiveness and cost-effectiveness of online-delivered brief mindfulness-based cognitive therapy (bMBCT) for improving productivity and other work-related outcomes among healthy workers compared to the waitlist control.
METHODS


We will conduct a 4-week randomized controlled trial (RCT) with a 6-month follow-up. Employees are included in the study if they (1) are between the ages of 20 and 65 years and (2) work longer than 30 hours weekly. Employees are randomly allocated to either the bMBCT group or the waitlist control group. The primary outcome of the study is the mean difference of productivity measured by the World Health Organization Health and Work Performance Questionnaire (WHO-HPQ) between the groups at 4, 16, and 28 weeks. Secondary outcomes include several clinical outcomes and health economics evaluation.
RESULTS


We started recruiting participants in August 2021, and the intervention began in October 2021. A total of 104 participants have been enrolled in the study as of October 2021. The intervention is scheduled to be completed in December 2023. Data collection will be completed by the end of January 2024.
CONCLUSIONS


The novelty of the study is that (1) it will investigate bMBCT's effectiveness on productivity, which is still unclear, and (2) samples are recruited from 3 companies in different industries. The limitations of the study are that (1) all measures assessed are in self-report format and (2) we lack an active control group. This study has the potential to provide new data on the relationship between MBPs and occupational health and productivity.
TRIAL REGISTRATION


University Hospital Medical Information Network Clinical Trials Registry UMIN000044721; https://tinyurl.com/4e2fh873.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/36012.",2022,"To date, however, the impact on productivity of MBPs in the workplace that feature these modifications has not been investigated.
","['Employees are included in the study if they 1) are between the ages of 20-65 and 2) work longer than 30 hours weekly', 'healthy workers', 'participants in August 2021 and the intervention began in October 2021', '104 participants have been enrolled in the study as of October 2021']","['online-delivered brief Mindfulness Based Cognitive Therapy (bMBCT', 'bMBCT group or wait-list control group', 'online brief Mindfulness-Based Cognitive Therapy']","['effectiveness and cost-effectiveness', 'Effectiveness and cost-effectiveness', 'mean difference of productivity measured by World Health Organization Health and Work Performance Questionnaire (WHO-HPQ', 'several clinical outcomes and health economics evaluation']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",104.0,0.130558,"To date, however, the impact on productivity of MBPs in the workplace that feature these modifications has not been investigated.
","[{'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Sado', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ninomiya', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Nagaoka', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Goto', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Koreki', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Zindel', 'Initials': 'Z', 'LastName': 'Segal', 'Affiliation': 'Graduate Department Psychological Clinical Science, University of Toronto Scarborough, Toronto, ON, Canada.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}]",JMIR research protocols,['10.2196/36012']
703,35357734,The Pro-Diab Melbourne Perioperative Study: A structured pre-admission perioperative diabetes management plan to improve medication usage in elective surgery.,"BACKGROUND


Perioperative diabetes management has become increasingly complex; management is often inconsistent resulting in dysglycaemia and associated morbidity.
AIM


To evaluate a structured pre-admission perioperative diabetes management plan (PDMP) for safe and appropriate recommendation, prescription and administration of diabetes medications in the perioperative period for people with diabetes undergoing elective, non-cardiac surgery.
METHODS


A multidisciplinary team developed the intervention, a structured PDMP (including diabetes medication reconciliation, management guide, individualised plan) to standardise optimal perioperative diabetes management. A single centre prospective pre- and post-intervention pilot study was performed, including all individuals with diabetes medications attending the pre-admissions clinic during two 4-month periods (February to May) in 2016 (control period) and 2017 (intervention period). The primary outcome was appropriate recommendation, prescription and administration of diabetes medications (including insulin), according to the PDMP, in the perioperative period. Secondary outcomes measures were glycaemia. Analysis was by intention to treat.
RESULTS


Control and intervention groups included 131 and 133 participants, respectively; they were well matched in clinical characteristics. The PDMP was completed correctly in 100 (75%) individuals in the intervention group. The appropriate use of diabetes medications increased from 30% in the control group to 71% in the intervention group (p < 0.001). Following the PDMP implementations, glycaemia improved in the overall perioperative period (8.7 ± 2.9 vs. 9.8 ± 3.3 mmol/L, p = 0.005) and at all time points (from admission and over entire hospital stay).
CONCLUSION


A structured pre-admission perioperative diabetes management plan for elective surgery improved safe and appropriate diabetes medication use and glycaemia in the perioperative period.",2022,A structured pre-admission perioperative diabetes management plan for elective surgery improved safe and appropriate diabetes medication use and glycaemia in the perioperative period.,"['people with diabetes undergoing elective, non-cardiac surgery', 'elective surgery', 'all individuals with diabetes medications attending the pre-admissions clinic during two 4-month periods (February to May) in 2016 (control period) and 2017 (intervention period']",['structured pre-admission perioperative diabetes management plan (PDMP'],"['appropriate recommendation, prescription and administration of diabetes medications (including insulin), according to the PDMP, in the perioperative period', 'diabetes medications', 'glycaemia', 'PDMP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0559269', 'cui_str': 'Pre-admission'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0559269', 'cui_str': 'Pre-admission'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}]",,0.0247891,A structured pre-admission perioperative diabetes management plan for elective surgery improved safe and appropriate diabetes medication use and glycaemia in the perioperative period.,"[{'ForeName': 'Qi Yang Damien', 'Initials': 'QYD', 'LastName': 'Qi', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Mervyn', 'Initials': 'M', 'LastName': 'Kyi', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pemberton', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter Grahame', 'Initials': 'PG', 'LastName': 'Colman', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Spiros', 'Initials': 'S', 'LastName': 'Fourlanos', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14838']
704,35394159,Comparison of TWA and PEP as indices of α2- and ß-adrenergic activation.,"RATIONALE


Pre-ejection period (PEP) and T-wave amplitude (TWA) have been used to assess sympathetic nervous system (SNS) activity. Here we report two single-blinded, placebo-controlled intravenous (IV) drug application studies in which we pharmacologically modified SNS activity with epinephrine (study 1) as well as dexmedetomidine (alpha2-agonist) and yohimbine (alpha2-antagonist) (study 2). Restricted heart rate (HR) intervals were analyzed to avoid confounding effects of HR changes.
OBJECTIVE


Study 1 served to replicate previous findings and to validate our approach, whereas study 2 aimed to investigate how modulation of central SNS activity affects PEP and TWA.
METHODS


Forty healthy volunteers (58% females) participated in study 1 (between-subject design). Twelve healthy men participated in study 2 (within-subject design). TWA and PEP were derived from ECG and impedance cardiography, respectively.
RESULTS


Epinephrine shortened PEP and induced statistically significant biphasic TWA changes. However, although the two alpha2-drugs significantly affected PEP as expected, no effects on TWA could be detected.
CONCLUSION


PEP is better suited to reflect SNS activity changes than TWA.",2022,"However, although the two alpha2-drugs significantly affected PEP as expected, no effects on TWA could be detected.
","['Forty healthy volunteers (58% females) participated in study 1 (between-subject design', 'Twelve healthy men participated in study 2 (within-subject design']","['T-wave amplitude (TWA', 'TWA and PEP', 'dexmedetomidine (alpha2-agonist) and yohimbine (alpha2-antagonist', 'placebo', 'epinephrine']","['TWA and PEP', 'Restricted heart rate (HR) intervals', 'biphasic TWA changes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0429103', 'cui_str': 'T wave feature'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0429103', 'cui_str': 'T wave feature'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",12.0,0.0748121,"However, although the two alpha2-drugs significantly affected PEP as expected, no effects on TWA could be detected.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Drost', 'Affiliation': 'Institute of Psychobiology, Department of Clinical Psychophysiology, University of Trier, Johanniterufer 15, 54290, Trier, Germany. s1lidros@uni-trier.de.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Finke', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Adolf-Reichwein-Str. 2a, 57076, Siegen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Port', 'Affiliation': 'Department of Biomedical Technic, University of Stuttgart, Seidenstraße 36, 70174, Stuttgart, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Schächinger', 'Affiliation': 'Institute of Psychobiology, Department of Clinical Psychophysiology, University of Trier, Johanniterufer 15, 54290, Trier, Germany.'}]",Psychopharmacology,['10.1007/s00213-022-06114-8']
705,35395021,A randomized controlled trial comparing self-referred message to family-referred message promoting men's adherence to evidence-based guidelines on BRCA1/2 germline genetic testing: A registered study protocol.,"BACKGROUND


This is a registered study protocol on a randomized controlled trial (RCT) testing an intervention aimed to improve men's adherence to evidence-based guidelines on BRCA1/2 germline genetic testing. BRCA1- and BRCA2-associated Hereditary Breast and Ovarian Cancer Syndrome (HBOC) increases the relative and absolute risk of developing breast and ovarian cancer and, to a lesser extent, prostate and pancreatic cancer. Men face BRCA-related cancer risks as women do, although with a different magnitude, and they may also transmit the mutations to their children. Notwithstanding, men are under-tested compared to women and the communication is not tailored on their needs. The present RCT applies principles of the Health Action Process Approach (HAPA) in testing the psychological determinants of the men's adherence to evidence based guidelines on BRCA1/2 germline genetic and testing the efficacy of two messages.
METHODS


A total of 264 participants will be involved, among the men's relatives of women with verified germline mutations. The study entails a pre- post- evaluation with randomization of the participants in two conditions corresponding to the two messages.
DISCUSSION


The expected results provide answers related to the impact of action self-efficacy, outcome expectancy (personal or familiar), risk perception, health risk aversion, intolerance of uncertainty, perceived barriers, and coping self-efficacy on informed decision-making. Data gathered from this study may inform health care providers, policy makers, and public health managers about the communication strategy for men and about the psychological variables influencing decision-making.
TRAIL REGISTRATION


Name of the Registry: Clinical Trials. Trial registration number: NCT04683068. Date of registration: 16/12/2020. URL of trial registry record: https://www.clinicaltrials.gov/.",2022,"The expected results provide answers related to the impact of action self-efficacy, outcome expectancy (personal or familiar), risk perception, health risk aversion, intolerance of uncertainty, perceived barriers, and coping self-efficacy on informed decision-making.","[""264 participants will be involved, among the men's relatives of women with verified germline mutations"", 'participants in two conditions corresponding to the two messages']",['self-referred message to family-referred message'],"['action self-efficacy, outcome expectancy (personal or familiar), risk perception, health risk aversion, intolerance of uncertainty, perceived barriers, and coping self-efficacy']","[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206530', 'cui_str': 'Mutation, Germ-Line'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0233496', 'cui_str': 'Aversion'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",264.0,0.307043,"The expected results provide answers related to the impact of action self-efficacy, outcome expectancy (personal or familiar), risk perception, health risk aversion, intolerance of uncertainty, perceived barriers, and coping self-efficacy on informed decision-making.","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Petrocchi', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Ongaro', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Mariarosaria', 'Initials': 'M', 'LastName': 'Calvello', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Feroce', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Bonanni', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}]",PloS one,['10.1371/journal.pone.0266327']
706,35397367,Plasma lathosterol measures rates of cholesterol synthesis and efficiency of dietary phytosterols in reducing the plasma cholesterol concentration.,"OBJECTIVES


Because the plasma campesterol/cholesterol ratio does not differ between groups that absorb different amounts of cholesterol, the authors investigated whether the plasma Phytosterols (PS) relate to the body's cholesterol synthesis rate measured as non-cholesterol sterol precursors (lathosterol).
METHOD


The authors studied 38 non-obese volunteers (58±12 years; Low-Density Lipoprotein Cholesterol ‒ LDL-C ≥ 130 mg/dL) randomly assigned to consume 400 mL/day of soy milk (Control phase) or soy milk + PS (1.6 g/day) for four weeks in a double-blind, cross-over study. PS and lathosterol were measured in plasma by gas chromatography coupled to mass spectrophotometry.
RESULTS


PS treatment reduced plasma total cholesterol concentration (-5.5%, p < 0.001), LDL-C (-7.6%, p < 0.001), triglycerides (-13.6%, p < 0.0085), and apolipoprotein B (apo B) (-6.3%, p < 0.008), without changing high density lipoprotein cholesterol (HDL-C concentration), but plasma lathosterol, campesterol and sitosterol expressed per plasma cholesterol increased.
CONCLUSIONS


The lathosterol-to-cholesterol plasma ratio predicted the plasma cholesterol response to PS feeding. The highest plasma lathosterol concentration during the control phase was associated with a lack of response of plasma cholesterol during the PS treatment period. Consequently, cholesterol synthesis in non-responders to dietary PS being elevated in the control phase indicates these cases resist to further synthesis rise, whereas responders to dietary PS, having in the control phase synthesis values lower than non-responders, expand synthesis on alimentary PS. Responders absorb more PS than non-responders, likely resulting from responders delivering into the intestinal lumen less endogenous cholesterol than non-responders do, thus facilitating greater intestinal absorption of PS shown as increased plasma PS concentration.",2022,"RESULTS


PS treatment reduced plasma total cholesterol concentration (-5.5%, p < 0.001), LDL-C (-7.6%, p < 0.001), triglycerides (-13.6%, p < 0.0085), and apolipoprotein B (apo B) (-6.3%, p < 0.008), without changing high density lipoprotein cholesterol (HDL-C concentration), but plasma lathosterol, campesterol and sitosterol expressed per plasma cholesterol increased.
",['38\xa0non-obese volunteers (58±12\xa0years; Low-Density Lipoprotein Cholesterol ‒ LDL-C\xa0≥'],['consume 400\xa0mL/day of soy milk (Control phase) or soy milk\xa0+\xa0PS'],"['density lipoprotein cholesterol (HDL-C concentration), but plasma lathosterol, campesterol and sitosterol expressed per plasma cholesterol increased', 'plasma total cholesterol concentration', 'plasma cholesterol concentration', 'plasma PS concentration', 'plasma cholesterol', 'PS and lathosterol', 'LDL-C', 'highest plasma lathosterol concentration', 'triglycerides', 'cholesterol synthesis', 'apolipoprotein B', 'lathosterol-to-cholesterol plasma ratio', 'plasma campesterol/cholesterol ratio']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0452741', 'cui_str': 'Soya milk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0064673', 'cui_str': 'Lathosterol'}, {'cui': 'C0054560', 'cui_str': 'campesterol'}, {'cui': 'C0037215', 'cui_str': 'Sitosterols'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0858226', 'cui_str': 'Plasma cholesterol increased'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0405272,"RESULTS


PS treatment reduced plasma total cholesterol concentration (-5.5%, p < 0.001), LDL-C (-7.6%, p < 0.001), triglycerides (-13.6%, p < 0.0085), and apolipoprotein B (apo B) (-6.3%, p < 0.008), without changing high density lipoprotein cholesterol (HDL-C concentration), but plasma lathosterol, campesterol and sitosterol expressed per plasma cholesterol increased.
","[{'ForeName': 'Valéria Sutti', 'Initials': 'VS', 'LastName': 'Nunes', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil. Electronic address: valeria.sutti@hc.fm.usp.br.'}, {'ForeName': 'Angela de Oliveira Godoy', 'Initials': 'AOG', 'LastName': 'Ilha', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Guilherme da Silva', 'Initials': 'GDS', 'LastName': 'Ferreira', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Renata de Paula Assis', 'Initials': 'RPA', 'LastName': 'Bombo', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Milessa Silva', 'Initials': 'MS', 'LastName': 'Afonso', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Silvia Ferrari', 'Initials': 'MSF', 'LastName': 'Lavrador', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Roberta Marcondes', 'Initials': 'RM', 'LastName': 'Machado', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Edna Regina', 'Initials': 'ER', 'LastName': 'Nakandakare', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Eder Carlos Rocha', 'Initials': 'ECR', 'LastName': 'Quintão', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Lottenberg', 'Affiliation': 'Laboratório de Lipides (LIM10), Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil; Faculdade Israelita de Ciências da Saúde Albert Einstein (FICSAE), São Paulo, SP, Brazil.'}]","Clinics (Sao Paulo, Brazil)",['10.1016/j.clinsp.2022.100028']
707,35397332,"In response to: Comment on: ""Ultrasound-guided erector spinae plane block for postoperative analgesia in patients undergoing open radical prostatectomy: A randomized, placebo-controlled trial"".",,2022,,['patients undergoing open radical prostatectomy'],"['placebo', 'Ultrasound-guided erector spinae plane block']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",[],,0.349287,,"[{'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Dost', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey. Electronic address: burhandost@hotmail.com.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Kaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Sezgin', 'Initials': 'S', 'LastName': 'Bilgin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Yasemin Burcu', 'Initials': 'YB', 'LastName': 'Ustun', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Koksal', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2022.110808']
708,35403447,"A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer.","Background:  Cabozantinib inhibits pathways involved in medullary thyroid cancer (MTC). Cabozantinib is approved as 140 mg/day in capsules for MTC and 60 mg/day in tablets for other solid tumors. This study compared the two doses in progressive metastatic MTC.  Methods:  In this Phase 4, randomized, double-blind noninferiority (NI) trial (NCT01896479), patients with progressive metastatic MTC were randomized 1:1 to cabozantinib 60 mg/day tablet or 140 mg/day capsules. The primary end point was progression-free survival (PFS) by blinded independent radiology committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. NI would be concluded if the upper 95% confidence interval [CI] for the PFS hazard ratio (HR) was less than the NI margin, 1.58. The secondary end point was objective response rate (ORR) by BIRC per RECIST v1.1; additional end points included safety and pharmacokinetics.  Results:  At data cutoff (July 15, 2020), 247 patients were randomized to the 60 mg/day tablet arm ( n  = 123) and the 140 mg/day capsules arm ( n  = 124). NI was not met (median PFS 11.0 months vs. 13.9 months in the 60 and 140 mg/day arms [HR 1.24; CI 0.90-1.70;  p  = 0.19]). The ORR was 33% in both arms. Generally, adverse event (AE) incidence was lower in the 60 mg/day arm (Grade 3/4, 63% vs. 72%), as were dose reductions (69% vs. 81%) and treatment discontinuations due to AEs (23% vs. 36%). Initially, cabozantinib plasma concentrations were higher in the 140 mg/day arm but became similar between arms at later time points.  Conclusions:  PFS NI of the cabozantinib 60 mg/day tablet vs. 140 mg/day capsules was not met. The 60 mg/day tablet had the same ORR and lower rates of AEs.  Clinical Trial Registry:  ClinicalTrials.gov NCT01896479.",2022,"Noninferiority would be concluded if the upper 95% confidence interval (CI) for the PFS hazard ratio (HR) was less than the noninferiority margin, 1.58.","['247 patients', 'patients with progressive metastatic MTC', 'Patients With Progressive, Metastatic Medullary Thyroid Cancer']","['Cabozantinib Capsule', 'cabozantinib 60-mg/day tablet or 140-mg/day capsules', 'Cabozantinib Tablet']","['PFS hazard ratio (HR', 'safety and pharmacokinetics', 'ORR and lower rates of AEs', 'objective response rate (ORR', 'adverse event (AE) incidence', 'cabozantinib plasma concentrations', 'progression-free survival (PFS', 'ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0238462', 'cui_str': 'Medullary thyroid carcinoma'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4237943', 'cui_str': 'cabozantinib 60 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",247.0,0.382007,"Noninferiority would be concluded if the upper 95% confidence interval (CI) for the PFS hazard ratio (HR) was less than the noninferiority margin, 1.58.","[{'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': 'Vall Hebron University Hospital and Vall Hebron Institute of Oncology (VHIO), IOB-Quiron-Teknon, Barcelona, Spain.'}, {'ForeName': 'Arkadiy', 'Initials': 'A', 'LastName': 'Klochikhin', 'Affiliation': 'Regional Clinical Oncology Hospital, Yaroslavl, Russian Federation.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Leboulleux', 'Affiliation': 'Gustave Roussy and University Paris Saclay, Villejuif, France.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Isaev', 'Affiliation': 'Federal State Institution Medical Radiology Research Center, Obninsk, Russian Federation.'}, {'ForeName': 'Corin', 'Initials': 'C', 'LastName': 'Badiu', 'Affiliation': '""C. I. Parhon,"" National Institute of Endocrinology and ""C. Davila"" University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Robinson', 'Affiliation': 'Royal North Shore Hospital, St Leonards, Australia.'}, {'ForeName': 'Brett G M', 'Initials': 'BGM', 'LastName': 'Hughes', 'Affiliation': ""Royal Brisbane & Women's Hospital, and University of Queensland, Herston, Australia.""}, {'ForeName': 'Bhumsuk', 'Initials': 'B', 'LastName': 'Keam', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Parnis', 'Affiliation': 'Adelaide Cancer Centre, Kurralta Park, Australia.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Elisei', 'Affiliation': 'Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Gajate', 'Affiliation': 'Hospital Universitario Ramon y Cajal, Madrid, Spain.'}, {'ForeName': 'Hui K', 'Initials': 'HK', 'LastName': 'Gan', 'Affiliation': 'Austin Hospital, Heidelberg, Melbourne, Australia.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kapiteijn', 'Affiliation': 'Leids Universitair Medisch Centrum, Leiden, The Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Locati', 'Affiliation': 'Istituto Nazionale Dei Tumori, Milano, Italy.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Mangeshkar', 'Affiliation': 'Exelixis, Inc., Alameda, California, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Faoro', 'Affiliation': 'Exelixis, Inc., Alameda, California, USA.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Krajewska', 'Affiliation': 'M. Sklodowska-Curie National Research Institute of Oncology Gliwice Branch, Gliwice, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Jarzab', 'Affiliation': 'M. Sklodowska-Curie National Research Institute of Oncology Gliwice Branch, Gliwice, Poland.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2022.0027']
709,35405011,Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study.,"CONTEXT


Somatrogon is a long-acting recombinant human growth hormone (rhGH) in development for once-weekly treatment of children with growth hormone deficiency (GHD).
OBJECTIVE


We aimed to compare the efficacy and safety of once-weekly somatrogon with once-daily somatropin in prepubertal children with GHD.
METHODS


In this 12-month, open-label, randomized, active-controlled, parallel-group, phase 3 study, participants were randomized 1:1 to receive once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for 12 months. A total of 228 prepubertal children (boys aged 3-11 years, girls aged 3-10 years) with GHD, impaired height and height velocity (HV), and no prior rhGH treatment were randomized and 224 received ≥1 dose of study treatment (somatrogon: 109; somatropin: 115). The primary endpoint was annualized HV at month 12.
RESULTS


HV at month 12 was 10.10 cm/year for somatrogon-treated subjects and 9.78 cm/year for somatropin-treated subjects, with a treatment difference (somatrogon-somatropin) of 0.33 (95% CI: -0.24, 0.89). The lower bound of the 2-sided 95% CI was higher than the prespecified noninferiority margin (-1.8 cm/year), demonstrating noninferiority of once-weekly somatrogon vs daily somatropin. HV at month 6 and change in height standard deviation score at months 6 and 12 were similar between both treatment groups. Both treatments were well tolerated, with a similar percentage of subjects experiencing mild to moderate treatment-emergent adverse events in both groups (somatrogon: 78.9%, somatropin: 79.1%).
CONCLUSION


The efficacy of once-weekly somatrogon was noninferior to once-daily somatropin, with similar safety and tolerability profiles. (ClinicalTrials.gov no. NCT02968004).",2022,"The efficacy of once-weekly somatrogon was non-inferior to once-daily somatropin, with similar safety and tolerability profiles.","['prepubertal children with GHD', 'girls aged 3-10 years) with GHD, impaired height and height velocity (HV), and no prior rhGH treatment were randomized and 224 received ≥1 dose of study treatment (somatrogon: 109; somatropin: 115', 'children with growth hormone deficiency', 'children with growth hormone deficiency (GHD', '228 prepubertal children (boys aged 3-11 years']","['somatrogon vs daily somatropin', 'recombinant human growth hormone (rhGH']","['height SDS', 'Efficacy and safety', 'efficacy and safety', 'tolerated', 'annualized HV at month 12']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",228.0,0.108193,"The efficacy of once-weekly somatrogon was non-inferior to once-daily somatropin, with similar safety and tolerability profiles.","[{'ForeName': 'Cheri L', 'Initials': 'CL', 'LastName': 'Deal', 'Affiliation': 'Centre de recherche CHU Ste-Justine, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Steelman', 'Affiliation': ""Cook Children's Medical Center, Fort Worth, TX, USA.""}, {'ForeName': 'Elpis', 'Initials': 'E', 'LastName': 'Vlachopapadopoulou', 'Affiliation': ""Children's Hospital P. & A. Kyriakou, Athens, Greece.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Stawerska', 'Affiliation': ""Polish Mother's Memorial Hospital-Research Institute, Lodz, and Medical University of Lodz, Lodz, Poland.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Silverman', 'Affiliation': ""Goryeb Children's Hospital, Atlantic Health System, Morristown, NJ, USA.""}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Schneider Children's Medical Center of Israel, Petah Tikva, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.""}, {'ForeName': 'Ho-Seong', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'CheolWoo', 'Initials': 'C', 'LastName': 'Ko', 'Affiliation': ""Kyungpook National University Children's Hospital, Daegu, South Korea.""}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Malievskiy', 'Affiliation': 'Bashkir State Medical University, Ufa, Russia.'}, {'ForeName': 'Jose F', 'Initials': 'JF', 'LastName': 'Cara', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Roland', 'Affiliation': 'Pfizer Inc, Sanford, NC, USA.'}, {'ForeName': 'Carrie Turich', 'Initials': 'CT', 'LastName': 'Taylor', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Srinivas Rao', 'Initials': 'SR', 'LastName': 'Valluri', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Wajnrajch', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Pastrak', 'Affiliation': 'OPKO Health, Miami, FL, USA.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Miller', 'Affiliation': ""University of Minnesota Masonic Children's Hospital, Minneapolis, MN, USA.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac220']
710,35364620,Values-based cognitive behavioural therapy for the prevention of chronic whiplash associated disorders: A randomized controlled trial.,"BACKGROUND


Whiplash is a common traffic-related injury with up to 50% of those affected continuing to experience symptoms one-year post-injury. Unfortunately, treatments have not proven highly effective in preventing and treating chronic symptomatology. The overall aim of this study was to test the effectiveness of an early values-based cognitive-behavioural therapeutic intervention (V-CBT) delivered within 6 months post-injury in preventing chronic symptomatology compared to wait list controls.
METHODS


The study was a two-armed randomized controlled trial. Participants (n = 91) experienced pain, disability and at least one psychological risk factor (e.g. enhanced pain-catastrophizing) after a whiplash trauma no later than 6 months prior. Participants were randomized to 10 sessions of V-CBT starting 1 week (group A) or 3 months (group B) post-randomization. The primary outcome was pain-related disability, while secondary outcomes were pain intensity, neck-pain related disability, depression, anxiety, PTSD symptoms, pain-catastrophizing and kinesiophobia. These were evaluated at baseline and at 3, 6, 9 and 12 months post-randomization.
RESULTS


At 3 months, group A demonstrated clinically important effects on all outcomes that were significantly better than group B (waitlist). When group B received the intervention at 6 months, they also demonstrated clinically important effects on all outcomes. However, there was a significant difference at 12 months for the primary outcome, in which group B increased their disability levels, while group A remained stable.
CONCLUSIONS


While this indicates that an intervention window for early prevention of disability after whiplash injury may exist, this needs to be tested in a truly early intervention.
SIGNIFICANCE


An early Values-based Cognitive Behavioural Therapeutic intervention delivered within 6 months post-injury (mean days 117) was effective in reducing pain-related disability and psychological distress compared to the control group that received the intervention later after a three months wait-list period. The effects were sustained at 12 months follow-up. The early intervention was significantly more effective in reducing pain-related disability compared to the control group, indicating that an intervention window for early prevention of disability after whiplash injury may exist.",2022,"At 3 months, group A demonstrated clinically important effects on all outcomes that were significantly better than group B (waitlist).","['Participants (n=91) experienced pain, disability, and at least one psychological risk factor (e.g., enhanced pain-catastrophizing) after a whiplash trauma no later than 6 months prior', 'Chronic Whiplash Associated Disorders']","['Values-based Cognitive Behavioral Therapy', 'early values-based cognitive-behavioral therapeutic intervention (V-CBT']","['pain intensity, neck-pain related disability, depression, anxiety, PTSD symptoms, pain-catastrophizing, and kinesiophobia', 'disability levels', 'chronic symptomatology', 'pain-related disability']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1292726', 'cui_str': 'Associated disorder'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.058655,"At 3 months, group A demonstrated clinically important effects on all outcomes that were significantly better than group B (waitlist).","[{'ForeName': 'Tonny Elmose', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark: Syddansk Universitet, Odense, Denmark.'}, {'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'Ravn', 'Affiliation': 'Department of Psychology, University of Southern Denmark: Syddansk Universitet, Odense, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mejldal', 'Affiliation': 'Unit of Clinical Alcohol Research, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kirsten Kaya', 'Initials': 'KK', 'LastName': 'Roessler', 'Affiliation': 'Department of Psychology, University of Southern Denmark: Syddansk Universitet, Odense, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1945']
711,35366329,Plasma Levels of Triglycerides and IL-6 Are Associated With Weight Regain and Fat Mass Expansion.,"CONTEXT


Long-term weight loss (WL) maintenance is the biggest challenge for overweight and obesity because of the almost unavoidable phenomenon of partial or even total weight regain (WR) after WL.
OBJECTIVE


In the present study we investigated the relations of (the changes of) adipocyte size and other risk biomarkers with WR during the follow-up of the Yoyo dietary intervention.
METHODS


In this randomized controlled study, 48 overweight/obese participants underwent a very-low-calorie diet to lose weight, followed by a weight-stable period of 4 weeks and a follow-up period of 9 months. Anthropometric measurements, adipocyte volume of abdominal subcutaneous adipose tissue, and plasma metabolic parameters (free fatty acids [FFAs], triglycerides [TGs], total cholesterol, glucose, insulin, homeostasis model assessment of insulin resistance [HOMA-IR], interleukin 6 [IL-6], angiotensin-converting enzyme [ACE] activity, retinol binding protein 4 [RBP4]) at the beginning and the end of follow-up were analyzed.
RESULTS


Our results show that changes of TGs, IL-6, HOMA-IR, and ACE are significantly positively correlated with WR. Multiple linear regression analysis shows that only TG and IL-6 changes remained significantly correlated with WR and increased body fat mass. Moreover, the change in HOMA-IR was tightly correlated with the change in TGs. Surprisingly, change in adipocyte volume during follow-up was not correlated with WR nor with other factors, but positive correlations between adipocyte volume and HOMA-IR were found at the beginning and end of the follow-up.
CONCLUSION


These results suggest that TGs and IL-6 are independently linked to WR via separate mechanisms, and that HOMA-IR and adipocyte volume may indirectly link to WR through the change of plasma TGs.",2022,"Surprisingly, the change of adipocyte volume during follow up was not correlated with WR nor with other factors, but positive correlations between adipocyte volume and HOMA-IR were found at the beginning and end of the follow up.
",['48 overweight/obese participants underwent a (very'],['low calorie diet'],"['TG and IL6', 'body fat mass', 'adipocyte volume and HOMA-IR', 'TG, IL6, HOMA-IR and ACE', 'HOMA-IR', 'change of adipocyte volume', 'Anthropometric measurements, adipocyte volume of abdominal subcutaneous adipose tissue and plasma metabolic parameters (FFA, TG, total cholesterol, glucose, insulin, HOMA-IR, IL6, ACE activity, RBP4', 'Plasma levels of triglycerides and IL6']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1563741', 'cui_str': 'Fat, Abdominal Subcutaneous'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1438309', 'cui_str': 'RBP4 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",48.0,0.0374823,"Surprisingly, the change of adipocyte volume during follow up was not correlated with WR nor with other factors, but positive correlations between adipocyte volume and HOMA-IR were found at the beginning and end of the follow up.
","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Qiao', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Freek G', 'Initials': 'FG', 'LastName': 'Bouwman', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Marleen A', 'Initials': 'MA', 'LastName': 'van Baak', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Nadia J T', 'Initials': 'NJT', 'LastName': 'Roumans', 'Affiliation': 'Institute for Technology-Inspired Regenerative Medicine, MERLN, Maastricht University Medical Centre, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Roel G', 'Initials': 'RG', 'LastName': 'Vink', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Edwin C M', 'Initials': 'ECM', 'LastName': 'Mariman', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, 6200 MD, Maastricht, the Netherlands.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac198']
712,35373894,"In-home use of a hybrid closed loop achieves time-in-range targets in preschoolers and school children: Results from a randomized, controlled, crossover trial.","AIM


To obtain additional information on the incremental differences between using a sensor-augmented pump (SAP) without automated insulin delivery (AID), using it with predictive low-glucose management (PLGM) or as hybrid closed loop (HCL), in preschool and school children.
METHODS


We conducted a monocentric, randomized, controlled, two-phase crossover study in 38 children aged 2-6 and 7-14 years. The primary endpoint was the percentage of time in range (TIR) of 70-180 mg/dl. Other continuous glucose sensor metrics, HbA1c, patient-related outcomes (DISABKIDS questionnaire, Fear of Hypoglycaemia Survey) and safety events were also assessed. Results from 2 weeks of SAP, 8 weeks of PLGM and 8 weeks of HCL were compared using a paired t-test or Wilcoxon signed-rank test.
RESULTS


Overall, we found a high rate of TIR target (>70%) achievement with HCL in preschool (88%) and school children (50%), with average times in Auto Mode of 93% and 87%, respectively. Preschool children achieved a mean TIR of 73% ± 6% (+8% vs. SAP, +6% vs. PLGM) and school children 69% ± 8% (+15% vs. SAP and + 14% vs. PLGM). Overall, HbA1c improved from 7.4% ± 0.9% to 6.9% ± 0.5% (P = .0002). Diabetes burden and worries and fear of hypoglycaemia remained at low levels, without significant changes versus PLGM. No events of severe hypoglycaemia or diabetic ketoacidosis occurred.
CONCLUSIONS


Preschool children profit from AID at least as much as those aged 7 years and older. To ensure safe use and prescribing modalities, regulatory approval is also required for young children.",2022,Overall HbA1c improved from 7.4±0.9% to 6.9±0.5%.,"['preschoolers and school children', '38 children 2-6 and 7-14\u2009years of age', 'Preschool children', 'young children']","['hybrid closed loop', 'sensor-augmented pump (SAP) without automated insulin delivery (AID), using it with predictive low-glucose suspension (PLGM) or as hybrid closed loop (HCL']","['Diabetes burden and worries and fear of hypoglycemia', 'high rate of TIR target', 'percentage of time in range (TIR', 'severe hypoglycemia or diabetic ketoacidosis', 'questionnaire, Fear of Hypoglycemia Survey) and safety events', 'Overall HbA1c', 'mean TIR']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0023443', 'cui_str': 'Hairy cell leukemia'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",38.0,0.089621,Overall HbA1c improved from 7.4±0.9% to 6.9±0.5%.,"[{'ForeName': 'Thekla', 'Initials': 'T', 'LastName': 'von dem Berge', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Remus', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Biester', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Reschke', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Klusmeier', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Adolph', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Holtdirk', 'Affiliation': 'CRO-Kottmann, Statistics, Hamm, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'An der Elbaue 12, Pirna, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kordonouri', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Biester', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14706']
713,35376986,Examining the protective role of the posterior elements of the spine against endplate fractures in a porcine model.,"Previous studies have shown that the posterior elements/facet joints provide strength to the overall functional spine unit (FSU) by taking 3-25% of vertical compressive load off the intervertebral disc (IVD). However, little is known regarding whether this offloading has a protective effect against endplate fracture. Therefore, the purpose of this study was to investigate if the posterior elements provide a protective role to the endplate in porcine cervical spines under fracture-inducing conditions. Twenty-two cervical porcine FSUs (C5/6 level) were randomized into two groups: 1) a control group which had their posterior elements left intact (n = 11); 2) an experimental group which had the posterior elements removed (n = 11). Each FSU underwent a previously reported rapid IVD pressurization protocol in order to create endplate fractures. Briefly, hydraulic fluid was rapidly injected into the IVD via a standard inflation needle inserted through the anterior annulus which was connected to a hydraulic pump and pressure transducer. Post pressurization, each FSU was dissected to determine the presence and size of endplate fracture. Peak pressurization and rate of pressurization were not found to differ between intact and cut specimens (p = 0.313 and 0.101, respectively). In contrast, significantly, more cut FSUs sustained an endplate fracture (11/11) compared to intact FSUs (5/11); p = 0.012. Further, cut FSUs resulted in a fracture area 1.91 times greater in size compared to the fractures seen in the intact FSUs (p = 0.011). Therefore, posterior elements appear to decrease the risk and severity of endplate fracture.",2022,"Peak pressurization and rate of pressurization were not found to differ between intact and cut specimens (p = 0.313 and 0.101, respectively).",['Twenty-two cervical porcine FSUs (C5/6 level'],['control group which had their posterior elements left intact'],"['cut FSUs sustained an endplate fracture', 'Peak pressurization and rate of pressurization', 'risk and severity of endplate fracture']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]","[{'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",22.0,0.0626095,"Peak pressurization and rate of pressurization were not found to differ between intact and cut specimens (p = 0.313 and 0.101, respectively).","[{'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Chow', 'Affiliation': 'Department of Kinesiology and Physical Education, Wilfrid Laurier University, Waterloo, ON, Canada.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'McMorran', 'Affiliation': 'Department of Kinesiology and Physical Education, Wilfrid Laurier University, Waterloo, ON, Canada.'}, {'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'Gregory', 'Affiliation': 'Department of Kinesiology and Physical Education, Wilfrid Laurier University, Waterloo, ON, Canada. dgregory@wlu.ca.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-022-07196-w']
714,35381390,Bone geometry in older adults with subclinical hypothyroidism upon levothyroxine therapy: A nested study within a randomized placebo controlled trial.,"The effect of levothyroxine (LT4) therapy for subclinical hypothyroidism (SHypo) on appendicular bone geometry and volumetric density has so far not been studied. In a nested study within the randomized, placebo-controlled Thyroid Hormone Replacement for Subclinical Hypothyroidism (TRUST) trial, we assessed the effect of LT4 therapy on bone geometry as measured by peripheral quantitative computed tomography (pQCT). In the TRUST trial, community-dwelling adults aged ≥65 years with SHypo were randomized to LT4 with dose titration vs. placebo with mock titration. We analyzed data from participants enrolled at the TRUST site in Bern, Switzerland who had bone pQCT measured at baseline and at 1 to 2 years follow-up. The primary outcomes were the annual percentage changes of radius and tibia epi- and diaphysis bone geometry (total and cortical cross-sectional area (CSA) and cortical thickness), and of volumetric bone mineral density (bone mineral content (BMC) and total, trabecular and cortical volumetric bone mineral density (vBMD)). We performed linear regression of the annual percentage changes adjusted for sex, LT4 dose at randomization and muscle cross-sectional area. The 98 included participants had a mean age of 73.9 (±SD 5.4) years, 45.9% were women, and 12% had osteoporosis. They were randomized to placebo (n = 48) or LT4 (n = 50). Annual changes in BMC and vBMD were similar between placebo and LT4-treated groups, without significant difference in bone geometry or volumetric bone mineral density changes, neither at the diaphysis, nor at the epiphysis. For example, in the placebo group, epiphyseal BMC (radius) decreased by a mean 0.2% per year, with a similar decrease of 0.5% per year in the LT4 group (between-group difference in %ΔBMC 0.3, 95% CI -0.70 to 1.21, p = 0.91). Compared to placebo, LT4 therapy for an average 14 months had no significant effect on bone mass, bone geometry and volumetric density in older adults with subclinical hypothyroidism. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov numbers NCT01660126 (TRUST Thyroid trial) and NCT02491008 (Skeletal outcomes).",2022,"Annual changes in BMC and vBMD were similar between placebo and LT4-treated groups, without significant difference in bone geometry or volumetric bone mineral density changes, neither at the diaphysis, nor at the epiphysis.","['subclinical hypothyroidism (SHypo', '98 included participants had a mean age of 73.9 (±SD 5.4) years, 45.9% were women, and 12% had osteoporosis', 'older adults with subclinical hypothyroidism', 'participants enrolled at the TRUST site in Bern, Switzerland who had bone pQCT measured at baseline and at 1 to 2\u202fyears follow-up', 'older adults with subclinical hypothyroidism upon levothyroxine therapy', 'community-dwelling adults aged ≥65\u202fyears with SHypo']","['placebo, LT4 therapy', 'LT4', 'LT4 therapy', 'LT4 with dose titration vs. placebo', 'levothyroxine (LT4) therapy', 'placebo', 'placebo-controlled Thyroid Hormone Replacement']","['epiphyseal BMC (radius', 'BMC and vBMD', 'bone mass, bone geometry and volumetric density', 'annual percentage changes of radius and tibia epi- and diaphysis bone geometry (total and cortical cross-sectional area (CSA) and cortical thickness), and of volumetric bone mineral density (bone mineral content (BMC) and total, trabecular and cortical volumetric bone mineral density (vBMD', 'bone geometry or volumetric bone mineral density changes']","[{'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0242696', 'cui_str': 'Structure of diaphysis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",98.0,0.240945,"Annual changes in BMC and vBMD were similar between placebo and LT4-treated groups, without significant difference in bone geometry or volumetric bone mineral density changes, neither at the diaphysis, nor at the epiphysis.","[{'ForeName': 'Annina Elisabeth', 'Initials': 'AE', 'LastName': 'Büchi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Seraina', 'Initials': 'S', 'LastName': 'Netzer', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gonzalez Rodriguez', 'Affiliation': 'Interdisciplinary Center of Bone Diseases, Rheumatology Unit, Bone and Joint Department, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetology, Nutrition and Therapeutic Education, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Del Giovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'van Heemst', 'Affiliation': 'Department of Internal Medicine, section Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': 'Institute of Cardiovascular Medicine, University of Glasgow, Glasgow, Scotland, United Kingdom.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Rudi G J', 'Initials': 'RGJ', 'LastName': 'Westendorp', 'Affiliation': 'Department of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Institute of Cardiovascular Medicine, University of Glasgow, Glasgow, Scotland, United Kingdom; Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Mooijaart', 'Affiliation': 'Department of Internal Medicine, section Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Hans', 'Affiliation': 'Interdisciplinary Center of Bone Diseases, Rheumatology Unit, Bone and Joint Department, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'Department of Medicine, University of California, San Francisco, USA; Department of Epidemiology, University of California, San Francisco, USA; Department of Biostatistics, University of California, San Francisco, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Aeberli', 'Affiliation': 'Department of Rheumatology and Immunology, Inselspital, Bern University Hospital, Bern, Switzerland. Electronic address: daniel.aeberli@insel.ch.'}]",Bone,['10.1016/j.bone.2022.116404']
715,35385770,Whole-body cryostimulation does not disturb the homeostasis of the system in physically active men - Pilot study.,"Whole-body cryostimulation (W-BC) is commonly used following exercise to accelerate recovery or as a form of therapy to prevent and cure sports injuries. This study aimed to investigate the effect of a series of 24 W-BC sessions on morphological and rheological blood indicators in physically active men. Eighteen physically active men participated in the study (mean age 22.1 ± 0.07). They were divided into two groups depending on their self-reported levels of physical activity: moderate or high physical activity. The participants completed a total of 24 W-BC sessions every second day, over a span of two months. Blood was collected at baseline, immediately after and 24 h after the first treatment, before and after the 12th treatment, before, immediately after, and 24 h after the 24th treatment, and one, two, three, and four weeks after the 24th treatment. Rheological and morphological indicators of blood were examined. The number of leukocytes was decreased in the moderate activity group (p < 0.05) but not in the high intensity group, following the first W-BC session. There were no significant changes in elongation index (EI) at a shear stress of 2.19-31.04 (Pa) in both groups as well as at the following values: aggregation index (AI), the half time (T½) and the amplitude of aggregation (AMP) in both studied groups. Differences between the first and the 12th or the 24th session became apparent in some morphological indices in one or both groups. Changes in the morphological properties were not observed after the first exposure but became evident following repeated W-BC sessions.",2022,"There were no significant changes in elongation index (EI) at a shear stress of 2.19-31.04 (Pa) in both groups as well as at the following values: aggregation index (AI), the half time (T½) and the amplitude of aggregation (AMP) in both studied groups.","['physically active men', 'Eighteen physically active men participated in the study (mean age 22.1\u202f±\u202f0.07']",['24\u202fW-BC sessions'],"['elongation index (EI', 'amplitude of aggregation (AMP', 'number of leukocytes']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4518239', 'cui_str': '0.07'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",,0.0155751,"There were no significant changes in elongation index (EI) at a shear stress of 2.19-31.04 (Pa) in both groups as well as at the following values: aggregation index (AI), the half time (T½) and the amplitude of aggregation (AMP) in both studied groups.","[{'ForeName': 'Kepinska-Szyszkowska', 'Initials': 'KS', 'LastName': 'Magdalena', 'Affiliation': 'Institute of Applied Sciences, University of Physical Education in Krakow, Al. Jana Pawla II 78, 31-571, Krakow, Poland. Electronic address: magdalena.kepinska@awf.krakow.pl.'}, {'ForeName': 'Szarek', 'Initials': 'S', 'LastName': 'Marta', 'Affiliation': 'University of Physical Education in Krakow, Poland.'}, {'ForeName': 'Dabrowski', 'Initials': 'D', 'LastName': 'Zbigniew', 'Affiliation': 'Institute of Clinical Rehabilitation, University of Physical Education in Krakow, Poland.'}, {'ForeName': 'Szygula', 'Initials': 'S', 'LastName': 'Zbigniew', 'Affiliation': 'Department of Sport Medicine and Human Nutrition, Faculty of Physical Education and Sport, University of Physical Education in Krakow, Poland.'}]",Cryobiology,['10.1016/j.cryobiol.2022.03.008']
716,35386039,"Clinical trials-related knowledge, attitudes, and behaviors among Black and Latina women: A randomized controlled trial of the Women United: Clinical Trials and the Fight Against Breast Cancer Program.","Black and Latino adult cancer patients are underrepresented in cancer clinical trials, which limits generalizability of findings and amplifies disparities in healthcare access and outcomes. Community-level education programs designed to address barriers to participation could improve representation in cancer clinical trials. Through a community-campus partner framework, this study evaluated the Women United: Clinical Trials and the Fight Against Breast Cancer Program in Spanish and English. Participants were 422 women (141 Black, 140 Latina Spanish preference, 141 Latina English preference) who were randomized to view either the intervention (n = 215) or a control (n = 207) program. Assessments of clinical trials knowledge and barriers to clinical trials participation were taken before and after viewing. Results suggested that clinical trials knowledge increased and perceived barriers to participation decreased for those who viewed the educational program. More specifically, those in the intervention condition perceived fewer barriers related to personal benefits, mistrust, and familiarity of clinical trials. As expected, there were no differences in perceived barriers related to community support for either condition. Participants in both conditions were equally likely to join a subsequent study or a clinical trials community ambassador program. There were no differences in any of the outcomes across ethnicity or language, suggesting the program works equivalently across groups. This program is easy to administer and can be recommended for use among Black and Latina women to address factors related to clinical trials participation.",2022,"There were no differences in any of the outcomes across ethnicity or language, suggesting the program works equivalently across groups.","['Black and Latino adult cancer patients', 'Participants in both conditions were equally likely to join a subsequent study or a clinical trials community ambassador program', 'Black and Latina women', 'Participants were 422 women (141 Black, 140 Latina Spanish preference, 141 Latina English preference']",[],"['personal benefits, mistrust, and familiarity of clinical trials']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0376245', 'cui_str': 'English language'}]",[],"[{'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",422.0,0.136841,"There were no differences in any of the outcomes across ethnicity or language, suggesting the program works equivalently across groups.","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Merz', 'Affiliation': 'Department of Psychology, California State University, Dominguez Hills, 1000 E. Victoria Street, Carson, CA, 90747, USA. emerz@csudh.edu.'}, {'ForeName': 'Natasha E', 'Initials': 'NE', 'LastName': 'Riley', 'Affiliation': 'Vista Community Clinic, Vista, USA.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Malcarne', 'Affiliation': 'SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, USA.'}, {'ForeName': 'Georgia Robins', 'Initials': 'GR', 'LastName': 'Sadler', 'Affiliation': 'SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-022-02162-y']
717,35389963,Interrupting Prolonged Sitting with Intermittent Walking Increases Postprandial Gut Hormone Responses.,"INTRODUCTION


Continuous exercise can increase postprandial gut hormone such as glucagon-like peptide 1 (GLP-1) and peptide YY (PYY) responses, but it is unknown whether interrupting prolonged sitting with intermittent walking elicits this effect.
METHOD


Ten participants with central overweight/obesity (7 men and 3 postmenopausal women, 51 ± 5 yr; mean ± SD) completed a randomized crossover study in which they consumed breakfast and lunch in the laboratory while either sitting continuously for the entire 5.5-h period (SIT) or the prolonged sitting interrupted every 20 min by walking briskly (6.4 km·h-1) for 2 min (BREAKS). Blood samples were collected at regular intervals to examine postprandial plasma GLP-1, PYY, and glucose-dependent insulinotropic polypeptide concentrations. Adipose tissue samples were collected at baseline and at the end of the trials to examine changes in net dipeptidyl peptidase 4 secretion from primary explants.
RESULTS


Mean (95% confidence interval) postprandial GLP-1 and PYY incremental area under curve values were elevated by 26% and 31% in the BREAKS trial versus SIT (8.4 [0.7, 16.1] vs 6.7 [-0.8, 14.2], P = 0.001, and 26.9 [8.1, 45.6] vs 20.4 [5.1, 35.8] nmol·330 min·L-1, P = 0.024, respectively) but without any such effect on glucose-dependent insulinotropic polypeptide (P = 0.076) or net adipose tissue dipeptidyl peptidase 4 secretion (P > 0.05).
CONCLUSIONS


Interrupting prolonged sitting with regular short bouts of brisk walking increases postprandial GLP-1 and PYY concentrations in healthy middle-age men and women with central adiposity.",2022,"postprandial GLP-1 and PYY iAUCs were elevated by 26% and 31% in the BREAKS trial versus SIT (8.4 [0.7, 16.1] versus 6.7 [-0.8, 14.2], p = 0.001 and 26.9 [8.1, 45.6] versus 20.4 [5.1, 35.8] nmol·330 min·L-1, p = 0.024, respectively) but without any such effect on GIP (p = 0.076) or net adipose tissue DPP-4 secretion (p > 0.05).
","['Ten participants with central overweight/obesity (7 men and 3 postmenopausal women, 51 ± 5 y; mean ± SD', 'healthy middle-aged men and women with central adiposity']","['consumed breakfast and lunch in the laboratory whilst either sitting continuously for the entire 5.5-hour period (SIT) or with the prolonged sitting interrupted every 20 minutes by walking briskly', 'Interrupting prolonged sitting with regular short bouts of brisk walking']","['net adipose tissue DPP-4 secretion', 'postprandial gut hormone such as glucagon-like peptide 1 (GLP-1) and peptide YY (PYY) responses', 'Adipose tissue samples', 'postprandial GLP-1 and PYY iAUCs', 'postprandial plasma GLP-1, PYY and glucose-dependent insulinotropic polypeptide (GIP) concentrations']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C4551560', 'cui_str': 'Central obesity'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0585317', 'cui_str': 'Every twenty minutes'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0586544', 'cui_str': 'Adipose tissue sample'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",10.0,0.131044,"postprandial GLP-1 and PYY iAUCs were elevated by 26% and 31% in the BREAKS trial versus SIT (8.4 [0.7, 16.1] versus 6.7 [-0.8, 14.2], p = 0.001 and 26.9 [8.1, 45.6] versus 20.4 [5.1, 35.8] nmol·330 min·L-1, p = 0.024, respectively) but without any such effect on GIP (p = 0.076) or net adipose tissue DPP-4 secretion (p > 0.05).
","[{'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education and Sport Sciences, National Taiwan Normal University, Taipei, TAIWAN.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002903']
718,35392832,Effects of a staged integral art-based cognitive intervention (SIACI) program in older adults with cognitive impairments: protocol for a randomized controlled trial.,"BACKGROUND


Given the aging population worldwide and the COVID-19 pandemic, which has been found to be associated with a deterioration in Alzheimer's disease (AD) symptoms, investigating methods to prevent or delay cognitive decline in preclinical AD and AD itself is important. The trial described in this protocol aims to evaluate the effects of a staged integral art-based cognitive intervention (SIACI) in older adults with CIs (preclinical AD [SCD or MCI] and mild AD), in order to gather evidence on the effects of SIACI on cognition and psychological/psychosocial health gains and determine the mechanisms.
METHODS


The planned study is a single-center, parallel-arm, randomized controlled trial with allocation concealment and outcome assessor blinding. A total of 88 participants will be randomized to two groups: (i) an intervention group that receives the 16-week, 24-session SIACI program and (ii) a waitlist control group (which will receive the SIACI program after completing the follow-up assessment). Global cognitive function, specific domains of cognition (memory, language, executive function, and visuospatial skills), and other health-related outcomes (quality of life, anxiety, depression, sleep quality, and physical activity level) will be measured at baseline, immediately after the intervention, and at the 6-month follow-up. Blood biomarkers, event-related potential (ERP)-P300, and magnetic resonance imaging (MRI) data will be collected at baseline and immediately after the intervention to explore the mechanisms of SIACI.
DISCUSSION


The trial will elucidate the immediate and long-term effects of SIACI based on neuropsychological testing and blood biomarkers, and neuroscience involving ERP-P300 and MRI parameters will make it possible to explore the mechanisms of SIACI in older adults with CIs. The results will provide evidence on the effectiveness of an AT-based cognitive intervention, which may delay or even halt cognitive decline in preclinical AD and AD itself.
TRIAL REGISTRATION


ChiCTR, ChiCTR2100044959 . Registered 03 April 2021.",2022,"The results will provide evidence on the effectiveness of an AT-based cognitive intervention, which may delay or even halt cognitive decline in preclinical AD and AD itself.
","['88 participants', 'older adults with CIs', 'older adults with CIs (preclinical AD [SCD or MCI] and mild AD', 'older adults with cognitive impairments']","['staged integral art-based cognitive intervention (SIACI', 'staged integral art-based cognitive intervention (SIACI) program', '24-session SIACI program and (ii) a waitlist control group (which will receive the SIACI program', 'SIACI']","['Global cognitive function, specific domains of cognition (memory, language, executive function, and visuospatial skills), and other health-related outcomes (quality of life, anxiety, depression, sleep quality, and physical activity level', 'Blood biomarkers, event-related potential (ERP)-P300, and magnetic resonance imaging (MRI) data']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",88.0,0.330202,"The results will provide evidence on the effectiveness of an AT-based cognitive intervention, which may delay or even halt cognitive decline in preclinical AD and AD itself.
","[{'ForeName': 'Yuan-Jiao', 'Initials': 'YJ', 'LastName': 'Yan', 'Affiliation': 'Research Center for Nursing Theory and Practice, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No.134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Ming-Ping', 'Initials': 'MP', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No. 134 Dongjie Street, Gulou District, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Wen-Chao', 'Initials': 'WC', 'LastName': 'Cai', 'Affiliation': 'Department of Radiology, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No. 134 Dongjie Street, Gulou District, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Chen-Shan', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'The School of Nursing, Fujian Medical University, No.88 Jiaotong Road, Fuzhou, 350004, Fujian Province, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Research Center for Nursing Theory and Practice, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No.134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Yu-Fei', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Chinese Language and Literature, Xiamen University, No. 422 Siming South Road, Xiamen, 361005, Fujian Province, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Research Center for Nursing Theory and Practice, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No.134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China. leehong99@126.com.'}]",BMC geriatrics,['10.1186/s12877-022-02961-4']
719,35392827,Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness.,"BACKGROUND


The purpose of the study is to evaluate the effect of an Advance Care Planning (ACP) Video Program on documented Do-Not-Hospitalize (DNH) orders among nursing home (NH) residents with advanced illness.
METHODS


Secondary analysis on a subset of NHs enrolled in a cluster-randomized controlled trial (41 NHs in treatment arm implemented the ACP Video Program: 69 NHs in control arm employed usual ACP practices). Participants included long (> 100 days) and short (≤ 100 days) stay residents with advanced illness (advanced dementia or cardiopulmonary disease (chronic obstructive pulmonary disease or congestive heart failure)) in NHs from March 1, 2016 to May 31, 2018 without a documented Do-Not-Hospitalize (DNH) order at baseline. Logistic regression with covariate adjustments was used to estimate the impact of the resident being in a treatment versus control NH on: the proportion of residents with new DNH orders during follow-up; and the proportion of residents with any hospitalization during follow-up. Clustering at the facility-level was addressed using hierarchical models.
RESULTS


The cohort included 6,117 residents with advanced illness (mean age (SD) = 82.8 (8.4) years, 65% female). Among long-stay residents (n = 3,902), 9.3% (SE, 2.2; 95% CI 5.0-13.6) and 4.2% (SE, 1.1; 95% CI 2.1-6.3) acquired a new DNH order in the treatment and control arms, respectively (average marginal effect, (AME) 5.0; SE, 2.4; 95% CI, 0.3-9.8). Among short-stay residents with advanced illness (n = 2,215), 8.0% (SE, 1.6; 95% CI 4.6-11.3) and 3.5% (SE 1.0; 95% CI 1.5-5.5) acquired a new DNH order in the treatment and control arms, respectively (AME 4.4; SE, 2.0; 95% CI, 0.5-8.3). Proportion of residents with any hospitalizations did not differ between arms in either cohort.
CONCLUSIONS


Compared to usual care, an ACP Video Program intervention increased documented DNH orders among NH residents with advanced disease but did not significantly reduce hospitalizations.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02612688 .",2022,"Compared to usual care, an ACP Video Program intervention increased documented DNH orders among NH residents with advanced disease but did not significantly reduce hospitalizations.
","['6,117 residents with advanced illness (mean age (SD)\u2009=\u200982.8 (8.4) years, 65% female', 'nursing home residents with advanced illness', 'Secondary analysis on a subset of NHs enrolled in a cluster-randomized controlled trial (41 NHs in treatment arm implemented the', 'nursing home (NH) residents with advanced illness', 'Participants included long (>\u2009100\xa0days) and short (≤\u2009100\xa0days) stay residents with advanced illness (advanced dementia or cardiopulmonary disease (chronic obstructive pulmonary disease or congestive heart failure)) in NHs from March 1, 2016 to May 31, 2018 without a documented Do-Not-Hospitalize (DNH) order at baseline']","['ACP Video Program intervention', 'advance care planning video', 'control NH', 'ACP Video Program: 69 NHs in control arm employed usual ACP practices', 'Advance Care Planning (ACP) Video Program']","['advanced illness', 'hospitalizations']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",6117.0,0.0808279,"Compared to usual care, an ACP Video Program intervention increased documented DNH orders among NH residents with advanced disease but did not significantly reduce hospitalizations.
","[{'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'McCreedy', 'Affiliation': 'Center for Gerontology and Healthcare Research, Brown University School of Public Health, 121 South Main St, Providence, RI, 02912, USA. ellen_mccreedy@brown.edu.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Center for Gerontology and Healthcare Research, Brown University School of Public Health, 121 South Main St, Providence, RI, 02912, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, 1200 Centre St, Boston, MA, 02131, USA.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Gutman', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, 121 South Main St, Providence, RI, 02912, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Teno', 'Affiliation': 'Oregon Health Sciences University School of Medicine, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Department of Economics and Health Care Management, Labovitz School of Business and Economics, University of Minnesota Duluth, 1518 Kirby Dr, Duluth, MN, 55806, USA.'}, {'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Moyo', 'Affiliation': 'Center for Gerontology and Healthcare Research, Brown University School of Public Health, 121 South Main St, Providence, RI, 02912, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Volandes', 'Affiliation': 'Section of General Medicine, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Gozalo', 'Affiliation': 'Center for Gerontology and Healthcare Research, Brown University School of Public Health, 121 South Main St, Providence, RI, 02912, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Belanger', 'Affiliation': 'Center for Gerontology and Healthcare Research, Brown University School of Public Health, 121 South Main St, Providence, RI, 02912, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ogarek', 'Affiliation': 'Center for Gerontology and Healthcare Research, Brown University School of Public Health, 121 South Main St, Providence, RI, 02912, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Center for Gerontology and Healthcare Research, Brown University School of Public Health, 121 South Main St, Providence, RI, 02912, USA.'}]",BMC geriatrics,['10.1186/s12877-022-02970-3']
720,35392818,"The MOMANT study, a caregiver support programme with activities at home for people with dementia: a study protocol of a randomised controlled trial.","BACKGROUND


Because of the expected increase in the number of people with dementia, and the associated social and economic costs, there is an urgent need to develop effective and cost-effective care for people with dementia and their caregivers. The intervention proposed here combines two approaches to caregiver support that have shown to be effective in empowering caregivers, i.e., multiple components for caregiver support and actively engaging caregivers to involve the person with dementia in activities at home. The aim is to investigate whether the intervention is effective in improving quality of life in the caregiver and the person with dementia. A further aim will be to investigate whether this intervention can improve caregivers' feeling of competence, experience of caregiving, and mood.
METHODS


The study design is a pragmatic, cluster randomised controlled trial with cost-effectiveness analysis. The study participants are informal caregivers and home-living persons with dementia for whom they care, recruited in various regions in the Netherlands. The trial will compare outcomes in two groups of participants: 85 dyads who receive the intervention, and 85 dyads who receive care as usual. The intervention is a caregiver support training that is manual based and consists of 6 group sessions over 2 months. Training takes place in small groups of caregivers led by a health care professional presented at dementia day care centres. Randomisation occurs at the level of the day care centre. Participants are assessed on the outcome measures at baseline, prior to the intervention, and at 3 and 6 months after baseline.
DISCUSSION


The study will provide insight into effectiveness and cost-effectiveness of an intervention that has not previously been evaluated or implemented in the Netherlands. The intervention potentially adds to the effective support options for informal caregivers of people with dementia without greatly increasing the workload for health- or social care professionals.
TRIAL REGISTRATION


The trial is registered at the Dutch Trial Register at NTR6643 ; August 22 nd , 2017.",2022,"The intervention potentially adds to the effective support options for informal caregivers of people with dementia without greatly increasing the workload for health- or social care professionals.
","['people with dementia and their caregivers', 'two groups of participants: 85 dyads who receive the intervention, and 85 dyads who receive care as usual', 'for people with dementia', 'informal caregivers of people with dementia without greatly increasing the workload for health- or social care professionals', 'participants are informal caregivers and home-living persons with dementia for whom they care, recruited in various regions in the Netherlands', 'small groups of caregivers led by a health care professional presented at dementia day care centres']",['caregiver support programme with activities at home'],['quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0175952', 'cui_str': 'Day care center'}]","[{'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0826611,"The intervention potentially adds to the effective support options for informal caregivers of people with dementia without greatly increasing the workload for health- or social care professionals.
","[{'ForeName': 'S C E', 'Initials': 'SCE', 'LastName': 'Balvert', 'Affiliation': 'Department of Clinical Neuropsychology, Vrije Universiteit Amsterdam, van der Boechorststraat 7, 1081 BT, Amsterdam, the Netherlands. s.c.e.balvert@vu.nl.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Milders', 'Affiliation': 'Department of Clinical Neuropsychology, Vrije Universiteit Amsterdam, van der Boechorststraat 7, 1081 BT, Amsterdam, the Netherlands.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Heymans', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Bommel', 'Affiliation': 'Management & Support, Stadionweg 53HS, 1077 RZ, Amsterdam, the Netherlands.'}, {'ForeName': 'R-M', 'Initials': 'RM', 'LastName': 'Dröes', 'Affiliation': 'Department of Psychiatry, Department of Research and Innovation, Amsterdam University Medical Centers, Location VU University Medical Center, GGZ inGeest, Amsterdam, the Netherlands.'}, {'ForeName': 'E J A', 'Initials': 'EJA', 'LastName': 'Scherder', 'Affiliation': 'Department of Clinical Neuropsychology, Vrije Universiteit Amsterdam, van der Boechorststraat 7, 1081 BT, Amsterdam, the Netherlands.'}]",BMC geriatrics,['10.1186/s12877-022-02930-x']
721,35382758,Cognitive behavioral therapy versus general health education for family caregivers of individuals with heart failure: a pilot randomized controlled trial.,"BACKGROUND


While support from family caregivers is essential in the care of patients with heart failure (HF), caregiving places a considerable burden on family caregivers. We examined the preliminary effects of cognitive behavioral therapy (CBT) for caregivers of individuals with HF.
METHODS


In this pilot randomized controlled trial, patients with HF and their primary family caregivers (30 dyads) were randomized into CBT (n = 15) or general health education (GHE, n = 15) groups. Caregivers received 8 weekly individual sessions of either CBT (intervention) or GHE (attention control condition). Caregivers completed questionnaires at baseline, post-intervention, and 6 months. Saliva samples collected from caregivers at baseline and post-intervention were analyzed for salivary cortisol. The cortisol awakening response (CAR) and area under the curve (AUC) were calculated using log-transformed cortisol values. We analyzed data from 26 (14 receiving CBT and 12 receiving GHE) caregivers who received at least one session of CBT or GHE (modified intention-to treat) using linear mixed models. Each model included time, study group, and time-by-study group interaction as fixed effects.
RESULTS


Patients were older (66.94 ± 14.01 years) than caregivers (55.09 ± 15.24 years), and 54% of patients and 54% of caregivers were female. Most caregivers (58%) were spouses. A total of 14 (93%) CBT and 12 (80%) GHE participants received at least 1 session (p = .60), and 11 (73%) CBT and 11 (73%) GHE participants completed all 8 sessions (p = 1.00). There were no significant between-group differences in change for salivary cortisol or psychological outcomes. However, the CBT group had significant within-group improvements in perceived stress (p = .011), stress symptoms (p = .017), depression (p = .002), and anxiety (p = .006) from baseline to post-intervention, while the control group had no significant within-group change in the outcomes except for anxiety (p = .03). The significant improvements observed in the CBT group lasted for 6 months. No adverse effects were observed.
CONCLUSIONS


In this pilot trial, although between-group differences in change were not significant, CBT resulted in significant improvements in some psychological outcomes with no improvement in the control group. Our findings suggest the potential of the intervention to alleviate psychological distress in HF caregivers. Further examination in larger randomized trials is warranted.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01937936 (Registered on 10/09/2013).",2022,"However, the CBT group had significant within-group improvements in perceived stress (p = .011), stress symptoms (p = .017), depression (p = .002), and anxiety (p = .006) from baseline to post-intervention, while the control group had no significant within-group change in the outcomes except for anxiety (p = .03).","['family caregivers of individuals with heart failure', 'patients with HF and their primary family caregivers (30 dyads', 'patients with heart failure (HF', 'HF caregivers', 'caregivers of individuals with HF.\nMETHODS', 'Patients were older (66.94\u2009±\u200914.01\u2009years) than caregivers (55.09\u2009±\u200915.24\u2009years), and 54% of patients and 54% of caregivers were female', '26 (14 receiving CBT and 12 receiving GHE) caregivers who received at least one session of CBT or GHE (modified intention-to treat) using linear mixed models']","['GHE', 'cognitive behavioral therapy (CBT', 'Cognitive behavioral therapy versus general health education', 'general health education (GHE', 'CBT (intervention) or GHE (attention control condition', 'CBT']","['cortisol awakening response (CAR) and area under the curve (AUC', 'stress symptoms', 'perceived stress', 'salivary cortisol or psychological outcomes', 'psychological outcomes', 'adverse effects', 'depression', 'anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.14793,"However, the CBT group had significant within-group improvements in perceived stress (p = .011), stress symptoms (p = .017), depression (p = .002), and anxiety (p = .006) from baseline to post-intervention, while the control group had no significant within-group change in the outcomes except for anxiety (p = .03).","[{'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Hwang', 'Affiliation': 'College of Nursing & Research Institute of Nursing Science, Seoul National University, Seoul, South Korea. bhwang@snu.ac.kr.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Granger', 'Affiliation': 'Institute for Interdisciplinary Salivary Bioscience Research, University of California, Irvine, CA, USA.'}, {'ForeName': 'Mary-Lynn', 'Initials': 'ML', 'LastName': 'Brecht', 'Affiliation': 'School of Nursing, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Lynn V', 'Initials': 'LV', 'LastName': 'Doering', 'Affiliation': 'School of Nursing, University of California, Los Angeles, CA, USA.'}]",BMC geriatrics,['10.1186/s12877-022-02996-7']
722,35397622,The potential prolonged effect at one-year follow-up after 18-month randomized controlled trial of a 90 g/day low-carbohydrate diet in patients with type 2 diabetes.,"OBJECTIVES


To evaluate the effect at a one-year follow-up after an 18-month randomized controlled trial (RCT) of 90 gm/day low-carbohydrate diet (LCD) in type 2 diabetes.
RESEARCH DESIGN AND METHODS


Eighty-five poorly controlled type 2 diabetic patients with an initial HbA1c ≥ 7.5% who have completed an 18-month randomized controlled trial (RCT) on 90 g/day low-carbohydrate diet (LCD) were recruited and followed for one year. A three-day weighted food record, relevant laboratory tests, and medication effect score (MES) were obtained at the end of the previous trial and one year after for a total of 30 months period on specific diet.
RESULTS


71 (83.5%) patients completed the study, 35 were in TDD group and 36 were in LCD group. Although the mean of percentage changes in daily carbohydrate intake was significantly lower for those in TDD group than those in LCD group (30.51 ± 11.06% vs. 55.16 ± 21.79%, p = 0.0455) in the period between 18 months and 30 months, patients in LCD group consumed significantly less amount of daily carbohydrate than patients in TDD group (131.8 ± 53.9 g vs. 195.1 ± 50.2 g, p < 0.001). The serum HbA1 C , two-hour serum glucose, serum alanine aminotransferase (ALT), and MES were also significantly lower for the LCD group patients than those in the TDD group (p = 0.017, p < 0.001, p = 0.017, and p = 0.008 respectively). The mean of percentage changes of HbA1 C , fasting serum glucose, 2 h serum glucose, as well as serum cholesterol, triglyceride, low-density lipoprotein, ALT, creatinine, and urine microalbumin, however, were not significantly different between the two groups (p > 0.05).
CONCLUSIONS


The one-year follow-up for patients on 90 g/d LCD showed potential prolonged and better outcome on glycaemic control, liver function and MES than those on TDD for poorly controlled diabetic patients.",2022,"LCD showed potential prolonged and better outcome on glycaemic control, liver function and MES than those on TDD for poorly controlled diabetic patients.","['type 2 diabetes', 'patients with type 2 diabetes', '71 (83.5%) patients completed the study, 35 were in TDD group and 36 were in LCD group', 'Eighty-five poorly controlled type 2 diabetic patients with an initial HbA1c\u2009≥\u20097.5% who have completed an 18-month randomized controlled trial (RCT) on 90\u2009g']","['90\u2009gm/day low-carbohydrate diet (LCD', 'LCD', 'day low-carbohydrate diet (LCD', '90\u2009g/day low-carbohydrate diet']","['serum HbA1 C , two-hour serum glucose, serum alanine aminotransferase (ALT), and MES', 'amount of daily carbohydrate', 'glycaemic control, liver function and MES', 'daily carbohydrate intake', 'mean of percentage changes of HbA1 C , fasting serum glucose, 2\u2009h serum glucose, as well as serum cholesterol, triglyceride, low-density lipoprotein, ALT, creatinine, and urine microalbumin']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0183841', 'cui_str': 'TDD'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1319171', 'cui_str': 'Medication response'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0740086', 'cui_str': 'Microalbuminuria measurement'}]",,0.0261968,"LCD showed potential prolonged and better outcome on glycaemic control, liver function and MES than those on TDD for poorly controlled diabetic patients.","[{'ForeName': 'Chin-Ying', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan. crystalcychen@ntu.edu.tw.'}, {'ForeName': 'Wei-Sheng', 'Initials': 'WS', 'LastName': 'Huang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Ming-Hua', 'Initials': 'MH', 'LastName': 'Ho', 'Affiliation': 'Department of Dietetics, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chin-Hao', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Research, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Long-Teng', 'Initials': 'LT', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Heng-Shuen', 'Initials': 'HS', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yow-Der', 'Initials': 'YD', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chu', 'Initials': 'WC', 'LastName': 'Chie', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, Department of Public Health, College of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chyi-Feng', 'Initials': 'CF', 'LastName': 'Jan', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Dean', 'Initials': 'WD', 'LastName': 'Wang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Jaw-Shiun', 'Initials': 'JS', 'LastName': 'Tsai', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}]",Nutrition & diabetes,['10.1038/s41387-022-00193-4']
723,35399071,Mindfulness-based stress reduction group training improves of sleep quality in postmenopausal women.,"BACKGROUND AND PURPOSE


Sleep disorder is one of the most common problems during menopause, which affects different areas of people's lives. Today, mindfulness is one of the concepts that have attracted a lot of attention due to its desirable effects and low side effects. The present study was conducted to investigate the effect of mindfulness-based stress reduction (MBSR) group training on sleep quality of postmenopausal women.
METHOD


This is a quasi-experimental parallel study. The study involved 66 eligible postmenopausal women 45-60 years' old (n = 33 in each group) during 2019-2020. The minimum score of women was 5 from Pittsburgh questionnaire. Eight sessions weekly (120-min/session) MBSR group training was conducted in the intervention group and menopausal health in the control group for two months. Pittsburgh Sleep Quality Questionnaire was used as a data collection tool. Descriptive statistics and nonparametric tests were utilized to analyze the data using SPSS software (version 25). The significance level < 0.05 was considered.
RESULTS


Socio-demographic characteristics of participants were no statistically significant difference between the study groups before the intervention. The results showed that mean of overall quality of sleep score was before the intervention 10.21 ± 3.03, after the intervention 4.7 ± 2.45, and one month after the intervention 4.69 ± 2.4 respectively in intervention group (P < 0.001). While there was no significant change in the mean overall quality of sleep quality in the control group.
CONCLUSION


According to the results, MBSR group training is an effective strategy for improving the sleep quality of postmenopausal women. Therefore, could be used to improve the sleep quality of postmenopausal women by midwifery consultants in health centers.",2022,"While there was no significant change in the mean overall quality of sleep quality in the control group.
","['postmenopausal women', 'postmenopausal women by midwifery consultants in health centers', ""66 eligible postmenopausal women 45-60\xa0years' old (n\u2009=\u200933 in each group) during 2019-2020""]","['Mindfulness-based stress reduction group training', 'MBSR', 'mindfulness-based stress reduction (MBSR) group training']","['sleep quality', 'mean overall quality of sleep quality', 'mean of overall quality of sleep score', 'Pittsburgh Sleep Quality Questionnaire', 'menopausal health']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",66.0,0.0166407,"While there was no significant change in the mean overall quality of sleep quality in the control group.
","[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Darehzereshki', 'Affiliation': 'Counseling in Midwifery, Faculty of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Dehghani', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Educational Sciences, Yazd University, Yazd, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Enjezab', 'Affiliation': 'Department of Midwifery, Research Center for Nursing and Midwifery Care, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. behnaz_enjezab@ssu.ac.ir.'}]",BMC psychiatry,['10.1186/s12888-022-03869-4']
724,35411007,Gut microbiome responses to dietary intervention with hypocholesterolemic vegetable oils.,"Hypercholesterolemia is becoming a problem with increasing significance. Dietary vegetable oils may help to improve this condition due to presence of phytonutrients with potentially synergistic cholesterol-lowering effects. The objective of this 8-week double-blinded randomized clinical trial was to investigate the effects of consuming 30 g of two different blended cooking oils, rich in omega-3 alpha-linolenic acid and phytonutrients, or refined olive oil on the intestinal microbiota in 126 volunteers with borderline hypercholesterolemia. Multi-factor analysis of relationships between the gut microbiota composition at various taxonomic ranks and the clinical trial parameters revealed the association between beneficial effects of the dietary intervention on the blood lipid profile with abundance of Clostridia class of the gut microbiota. This microbiota feature was upregulated in the course of the dietary intervention and associated with various plasma markers of metabolic health status, such as Triglycerides, Apolipoprotein B and Total Cholesterol to HDL ratio in a beneficial way. The relative abundance of a single species-Clostridium leptum-highly increased during the dietary intervention in all the three study groups. The oil blend with the highest concentration of omega-3 PUFA is associated with faster and more robust responses of the intestinal microbiota, including elevation of alpha-diversity. Butyrate production is being discussed as a plausible process mediating the observed beneficial influence on the plasma lipid profile. Causal mediation analysis suggested that Clostridium genus rather than the higher rank of the phylogeny-Clostridia class-may be involved in the diet-induced improvements of the blood lipid profile.",2022,The relative abundance of a single species-Clostridium leptum-highly increased during the dietary intervention in all the three study groups.,['126 volunteers with borderline hypercholesterolemia'],"['consuming 30\u2009g of two different blended cooking oils, rich in omega-3 alpha-linolenic acid and phytonutrients, or refined olive oil', 'dietary intervention', 'Dietary vegetable oils', 'Hypercholesterolemia', 'hypocholesterolemic vegetable oils']","['blood lipid profile', 'Triglycerides, Apolipoprotein B and Total Cholesterol to HDL ratio']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C2721593', 'cui_str': 'Borderline hypercholesterolaemia'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0577749', 'cui_str': 'Phytochemical'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0042438', 'cui_str': 'Vegetable oil'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",126.0,0.120467,The relative abundance of a single species-Clostridium leptum-highly increased during the dietary intervention in all the three study groups.,"[{'ForeName': 'Rachel Rui Xia', 'Initials': 'RRX', 'LastName': 'Lim', 'Affiliation': 'WIL@NUS Corporate Laboratory, National University of Singapore, Centre for Translational Medicine, Singapore, 117599, Singapore.'}, {'ForeName': 'Mi Ae', 'Initials': 'MA', 'LastName': 'Park', 'Affiliation': 'WIL@NUS Corporate Laboratory, National University of Singapore, Centre for Translational Medicine, Singapore, 117599, Singapore.'}, {'ForeName': 'Long Hui', 'Initials': 'LH', 'LastName': 'Wong', 'Affiliation': 'WIL@NUS Corporate Laboratory, National University of Singapore, Centre for Translational Medicine, Singapore, 117599, Singapore.'}, {'ForeName': 'Sumanto', 'Initials': 'S', 'LastName': 'Haldar', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science Technology and Research (A*STAR), Singapore, 117609, Singapore.'}, {'ForeName': 'Kevin Junliang', 'Initials': 'KJ', 'LastName': 'Lim', 'Affiliation': 'WIL@NUS Corporate Laboratory, National University of Singapore, Centre for Translational Medicine, Singapore, 117599, Singapore.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Nagarajan', 'Affiliation': 'Computational and Systems Biology, Genome Institute of Singapore (GIS), Singapore, 138672, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science Technology and Research (A*STAR), Singapore, 117609, Singapore.'}, {'ForeName': 'Yuan Rong', 'Initials': 'YR', 'LastName': 'Jiang', 'Affiliation': 'Wilmar (Shanghai) Biotechnology R & D Center Co., Ltd., 200137, Shanghai, China.'}, {'ForeName': 'Oleg Vladimirovich', 'Initials': 'OV', 'LastName': 'Moskvin', 'Affiliation': 'WIL@NUS Corporate Laboratory, National University of Singapore, Centre for Translational Medicine, Singapore, 117599, Singapore. bchv79@nus.edu.sg.'}]",NPJ biofilms and microbiomes,['10.1038/s41522-022-00287-y']
725,35413719,Effect of Maternal Docosahexaenoic Acid Supplementation on Very Preterm Infant Growth: Secondary Outcome of a Randomized Clinical Trial.,"INTRODUCTION


The aim of the study was to determine the effect of a maternal docosahexaenoic acid (DHA) supplementation during lactation, compared with a placebo, on the neonatal growth profile of breastfed very preterm infants.
METHODS


Preterm infants' growth profile, growth velocity from birth to 36 weeks' postmenstrual age (PMA), and growth at 36 weeks' PMA were pre-specified secondary outcomes of a randomized placebo-controlled trial conducted in 16 Canadian neonatal intensive care units (2015-2018). Lactating mothers who delivered before 29 weeks' gestation were given 1.2 g of DHA daily or a placebo within 72 h of delivery and up to 36 weeks' PMA. Analyses were performed using a linear regression model with generalized estimating equations.
RESULTS


461 mothers and their 528 infants (DHA, N = 273; placebo, N = 255) were included with mean gestational age of 26.5 weeks (standard deviation [SD] = 1.6); 275 (52.1%) were males; mean birth weight was 895 g (SD = 240). DHA interaction with sex was significant on weight profile (interaction p < 0.001), weight velocity (interaction p = 0.05), and weight at 36 weeks' PMA (interaction p = 0.02). Females in the DHA group gained more weight compared to the placebo group (mean difference [MD], 52.6 g [95% confidence interval [CI]: 24.5-80.8], p < 0.001). Weight velocity was significantly higher in females of the DHA group (MD, 3.4 g/kg/day [95% CI: 0.6-6.2], p = 0.02). At 36 weeks' PMA, the weight of males in the DHA group was significantly smaller (MD, -88.9 g [95% CI: -166.2 to -11.6], p = 0.02).
CONCLUSION


DHA positively affected female infants' neonatal weight profile and velocity and negatively affected male infants' weight at 36 weeks' PMA.",2022,"Weight velocity was significantly higher in females of the DHA group (MD, 3.4 g/kg/day","['461 mothers and their 528 infants (DHA, N = 273; placebo, N = 255) were included with mean gestational age of 26.5 weeks (standard deviation [SD] = 1.6); 275 (52.1%) were males; mean birth weight was 895 g (SD = 240', ""Preterm infants' growth profile, growth velocity from birth to 36 weeks' postmenstrual age (PMA), and growth at 36 weeks' PMA were pre-specified secondary outcomes of a randomized placebo-controlled trial conducted in 16 Canadian neonatal intensive care units (2015-2018"", ""Lactating mothers who delivered before 29 weeks' gestation"", 'Very Preterm Infant Growth', 'breastfed very preterm infants']","['placebo', 'Maternal Docosahexaenoic Acid Supplementation', 'maternal docosahexaenoic acid (DHA) supplementation']","['weight velocity', 'weight', 'weight of males', 'Weight velocity', 'weight profile']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0455808', 'cui_str': 'Weight velocity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",255.0,0.764297,"Weight velocity was significantly higher in females of the DHA group (MD, 3.4 g/kg/day","[{'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Angoa', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, CHU de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Pronovost', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, CHU de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Aissatou Bintou Khairy Thilor', 'Initials': 'ABKT', 'LastName': 'Ndiaye', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, CHU de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Pascal M', 'Initials': 'PM', 'LastName': 'Lavoie', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Lemyre', 'Affiliation': ""Division of Neonatology, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Mohamed', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simonyan', 'Affiliation': 'Clinical and Evaluative Research Platform, Centre de recherche du CHU de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Mosarrat', 'Initials': 'M', 'LastName': 'Qureshi', 'Affiliation': 'Division of Neonatology, Royal Alexandra Hospital, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jehier', 'Initials': 'J', 'LastName': 'Afifi', 'Affiliation': 'Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Yusuf', 'Affiliation': 'Department of Pediatrics, Section of Neonatology, Cumming School of Medicine, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Thibaut', 'Initials': 'T', 'LastName': 'Sériès', 'Affiliation': 'School of Psychology, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, Canada.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Guillot', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, CHU de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Piedboeuf', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, CHU de Québec-Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'William Donald', 'Initials': 'WD', 'LastName': 'Fraser', 'Affiliation': 'Department of Obstetrics and Gynecology, Centre de recherche du CHU de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Anne-Monique', 'Initials': 'AM', 'LastName': 'Nuyt', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Mâsse', 'Affiliation': 'Unité de Recherche Clinique Appliquée, CHU Sainte-Justine, Montréal, Québec, Canada.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lacaze-Masmonteil', 'Affiliation': 'Department of Pediatrics, Section of Neonatology, Cumming School of Medicine, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Marc', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, CHU de Québec-Université Laval, Québec, Québec, Canada.'}]",Neonatology,['10.1159/000524147']
726,35414517,"Relationship between age, workplace slips and the effectiveness of slip-resistant footwear among healthcare workers.","OBJECTIVES


To explore any age-related trend in workplace slip rate and assess the effectiveness of appropriate slip-resistant footwear in preventing workplace slips by age.
METHODS


Secondary data analysis of the Stopping Slips among Healthcare Workers trial, a two-arm randomised controlled trial conducted between March 2017 and May 2019. 4553 National Health Service (NHS) staff across seven sites in England were randomised 1:1 to the intervention group (provision of 5* GRIP-rated slip-resistant footwear) or the control group (usual work footwear). The primary outcome was self-reported workplace slips, ascertained primarily through weekly text messages throughout the 14-week trial follow-up and analysed using mixed-effects negative binomial regression. This paper reports a control group-only analysis of the association between age and slip rate, and a full intention-to-treat analysis of the effectiveness of slip-resistant footwear by age.
RESULTS


The mean age of participants was 43 years (range 18-74). In the control group-only analysis, slip rate differed by age (p<0.001) with those aged 60+ having double the slip rate of those aged <30 years (95% CI 1.40 to 2.87). In the intention-to-treat analysis, the interaction between allocation and age was statistically significant (p=0.002). In addition, for all age groups except those aged <30 years, the slip rate in the intervention group was statistically significantly lower than the control group; the smallest incidence rate ratio (ie, the biggest effect) was 0.39 (95% CI 0.24 to 0.64) in the 60+ age group.
CONCLUSION


The provision of appropriate slip-resistant footwear was more effective at reducing workplace slips for older NHS staff.",2022,"In the control group-only analysis, slip rate differed by age (p<0.001) with those aged 60+ having double the slip rate of those aged <30 years (95% CI 1.40 to 2.87).","['Secondary data analysis of the Stopping Slips among Healthcare Workers trial, a two-arm randomised controlled trial conducted between March 2017 and May 2019', 'The mean age of participants was 43 years (range 18-74', '4553 National Health Service (NHS) staff across seven sites in England']",['intervention group (provision of 5* GRIP-rated slip-resistant footwear) or the control group (usual work footwear'],"['smallest incidence rate ratio', 'self-reported workplace slips, ascertained primarily through weekly text messages', 'slip rate']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",,0.200956,"In the control group-only analysis, slip rate differed by age (p<0.001) with those aged 60+ having double the slip rate of those aged <30 years (95% CI 1.40 to 2.87).","[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Frost', 'Affiliation': 'HSE Science and Research Centre, Health and Safety Executive, Buxton, Derbyshire, UK gillian.frost@hse.gov.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Liddle', 'Affiliation': 'HSE Science and Research Centre, Health and Safety Executive, Buxton, Derbyshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cockayne', 'Affiliation': 'York Trials Unit, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Cunningham-Burley', 'Affiliation': 'York Trials Unit, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, University of York, York, North Yorkshire, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2022-044533']
727,35414345,Establishment of Prognostic Nomograms for Early-Onset Prostate Cancer Patients: A SEER Database Analysis.,"OBJECTIVE


Clinical prostate cancer (PCa) is rare in men aged <50 years (early-onset). A well-designed nomogram for prognosis prediction in patients with early-onset PCa has not been studied. Here, we tried to establish nomogram models of overall survival (OS) and cancer-specific survival (CSS) in patients with early-onset PCa.
METHODS


The clinical variables of patients diagnosed with early-onset PCa between 2004 and 2016 were retrieved from the Surveillance, Epidemiology, and End Results (SEER) database and randomly divided into training and validation groups at a ratio of 7:3. Multivariate Cox regression analyses were used to select prognostic factors associated with OS or CSS, followed by the construction and validation of nomograms.
RESULTS


We enrolled 8259 patients with early-onset PCa. New nomograms were established and showed good discriminative abilities. Finally, ROC curve analysis demonstrated that these nomograms were superior to the TNM stage and Gleason score in predicting both OS and CSS for patients with early-onset PCa.
CONCLUSION


This is the first study to establish nomograms with effective and high accuracy for prognosis in patients with early-onset PCa.",2022,"Here, we tried to establish nomogram models of overall survival (OS) and cancer-specific survival (CSS) in patients with early-onset PCa.
","['Early-Onset Prostate Cancer Patients', 'patients with early-onset PCa', 'men aged <50\u2009years (early-onset', 'patients diagnosed with early-onset PCa between 2004 and 2016 were retrieved from the Surveillance, Epidemiology, and End Results (SEER) database', '8259 patients with early-onset PCa']",[],"['TNM stage and Gleason score', 'overall survival (OS) and cancer-specific survival (CSS']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",8259.0,0.0824201,"Here, we tried to establish nomogram models of overall survival (OS) and cancer-specific survival (CSS) in patients with early-onset PCa.
","[{'ForeName': 'Jingtao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Jianghan University, Wuhan, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Department of Operation Room, The Second Affiliated Hospital of Jianghan University, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Jianghan University, Wuhan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, The Second Affiliated Hospital of Jianghan University, Wuhan, Hubei, China.'}, {'ForeName': 'Xiulan', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Oncology, The Second Affiliated Hospital of Jianghan University, Wuhan, China.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2022.2062495']
728,35414325,Effects of Sleep Restriction on Self-Reported Putting Performance in Golf.,"In the present study, we aimed to explore the effects of sleep restriction (SR) on self-reported golf putting skills. Eleven collegiate golfers participated in a self-reported, counterbalanced experimental study under two conditions: (a) a SR condition in which sleep on the night prior to putting was restricted to 4-5 hours, and (b) a habitual normal sleep (NS) condition on the night before the putting test. Following each sleep condition, participants engaged in ten consecutive putting tests at 7 am, 11 am, and 3 pm. Participants reported their subjective sleepiness before each time frame, and their chronotype, defined as their individual circadian preference, was scored based on a morningness-eveningness questionnaire (MEQ). Participants restricted sleep to an average period of 267.6 minutes/night ( SD  = 51.2 )  in the SR condition and 426.2 ( SD  =38.0) minutes/night in the NS condition. A two-way analysis of variance revealed a significant main effect of the sleep condition on the lateral displacement of putts from the target (lateral misalignment) ( p  = 0.002). In addition, there was a significant main effect of time on distance from the target (distance misalignment) ( p  = 0.017), indicating less accuracy of putting in the SR condition. In the SR condition, the MEQ score was positively correlated with distance misalignment at 3 pm ( ρ  = 0.650,  p  = 0.030), suggesting that morningness types are susceptible to the effects of SR on putting performance. Our findings suggest that golfers should obtain sufficient sleep to optimize putting performance.",2022,A two-way analysis of variance revealed a significant main effect of the sleep condition on the lateral displacement of putts from the target (lateral misalignment) ( p  = 0.002).,"['Eleven collegiate golfers participated in a self-reported, counterbalanced experimental study under two conditions: (a) a SR condition in which sleep on the night prior to putting was restricted to 4-5 hours, and (b) a habitual normal sleep (NS) condition on the night before the putting test']","['Sleep Restriction', 'sleep restriction (SR']","['MEQ score', 'subjective sleepiness']","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1442467', 'cui_str': '5 hours'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",11.0,0.017077,A two-way analysis of variance revealed a significant main effect of the sleep condition on the lateral displacement of putts from the target (lateral misalignment) ( p  = 0.002).,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Nishida', 'Affiliation': 'Faculty of Sport Sciences, 13148Waseda University, Saitama, Japan.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Chiba', 'Affiliation': 'Faculty of Sport Sciences, 13148Waseda University, Saitama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Murata', 'Affiliation': 'Sleep Research Institute,13148Waseda University, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shioda', 'Affiliation': 'Sleep Research Institute,13148Waseda University, Tokyo, Japan.'}]",Perceptual and motor skills,['10.1177/00315125221087027']
729,35417491,How do we raise media bias awareness effectively? Effects of visualizations to communicate bias.,"Media bias has a substantial impact on individual and collective perception of news. Effective communication that may counteract its potential negative effects still needs to be developed. In this article, we analyze how to facilitate the detection of media bias with visual and textual aids in the form of (a) a forewarning message, (b) text annotations, and (c) political classifiers. In an online experiment, we randomized 985 participants to receive a biased liberal or conservative news article in any combination of the three aids. Meanwhile, their subjective perception of media bias in this article, attitude change, and political ideology were assessed. Both the forewarning message and the annotations increased media bias awareness, whereas the political classification showed no effect. Incongruence between an articles' political position and individual political orientation also increased media bias awareness. Visual aids did not mitigate this effect. Likewise, attitudes remained unaltered.",2022,"Both the forewarning message and the annotations increased media bias awareness, whereas the political classification showed no effect.",['985 participants to receive a'],['biased liberal or conservative news article in any combination of the three aids'],['media bias awareness'],[],"[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",985.0,0.0308274,"Both the forewarning message and the annotations increased media bias awareness, whereas the political classification showed no effect.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Spinde', 'Affiliation': 'Department of Computer and Information Science, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Jeggle', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Haupt', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gaissmaier', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Giese', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}]",PloS one,['10.1371/journal.pone.0266204']
730,35418330,Letter comments on: D2 dissection improves disease-specific survival in advanced gastric cancer patients: 15-year follow-up results of the Italian gastric cancer study group D1 versus D2 randomised controlled trial.,,2022,,['advanced gastric cancer patients'],['D2 dissection'],['disease-specific survival'],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.368501,,"[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, 37 Guo Xue Rd, Chengdu, 610041, Sichuan Province, China. Electronic address: nutritioner@hotmail.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.02.033']
731,35377948,Predictive Markers of Response to Neoadjuvant Durvalumab with Nab-Paclitaxel and Dose-Dense Doxorubicin/Cyclophosphamide in Basal-Like Triple-Negative Breast Cancer.,"PURPOSE


We examined gene expression, germline variant, and somatic mutation features associated with pathologic response to neoadjuvant durvalumab plus chemotherapy in basal-like triple-negative breast cancer (bTNBC).
EXPERIMENTAL DESIGN


Germline and somatic whole-exome DNA and RNA sequencing, programmed death ligand 1 (PD-L1) IHC, and stromal tumor-infiltrating lymphocyte scoring were performed on 57 patients. We validated our results using 162 patients from the GeparNuevo randomized trial.
RESULTS


Gene set enrichment analysis showed that pathways involved in immunity (adaptive, humoral, innate), JAK-STAT signaling, cancer drivers, cell cycle, apoptosis, and DNA repair were enriched in cases with pathologic complete response (pCR), whereas epithelial-mesenchymal transition, extracellular matrix, and TGFβ pathways were enriched in cases with residual disease (RD). Immune-rich bTNBC with RD was enriched in CCL-3, -4, -5, -8, -23, CXCL-1, -3, -6, -10, and IL1, -23, -27, -34, and had higher expression of macrophage markers compared with immune-rich cancers with pCR that were enriched in IFNγ, IL2, -12, -21, chemokines CXCL-9, -13, CXCR5, and activated T- and B-cell markers (GZMB, CD79A). In the validation cohort, an immune-rich five-gene signature showed higher expression in pCR cases in the durvalumab arm (P = 0.040) but not in the placebo arm (P = 0.923) or in immune-poor cancers. Independent of immune markers, tumor mutation burden was higher, and PI3K, DNA damage repair, MAPK, and WNT/β-catenin signaling pathways were enriched in germline and somatic mutations in cases with pCR.
CONCLUSIONS


The TGFβ pathway is associated with immune-poor phenotype and RD in bTNBC. Among immune-rich bTNBC RD, macrophage/neutrophil chemoattractants dominate the cytokine milieu, and IFNγ and activated B cells and T cells dominate immune-rich cancers with pCR.",2022,"Independent of immune markers, tumor mutation burden was higher, and PI3K, DNA damage repair, MAPK, and WNT/β-Catenin signaling pathways were enriched in germline and somatic mutations in cases with pCR.
","['basal-like triple negative breast cancer (bTNBC', '162 patients from the GeparNuevo randomized trial', 'basal-like triple negative breast cancer']","['placebo', 'neoadjuvant durvalumab with nab-paclitaxel and dose dense doxorubicin/cyclophosphamide', 'neoadjuvant durvalumab plus chemotherapy']","['PI3K, DNA damage repair, MAPK, and WNT/β-Catenin signaling pathways', 'immunity (adaptive, humoral, innate), JAK-STAT signaling, cancer drivers, cell cycle, apoptosis and DNA repair']","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}, {'cui': 'C0012899', 'cui_str': 'DNA repair'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0007586', 'cui_str': 'Cell Division Cycle'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",57.0,0.0887537,"Independent of immune markers, tumor mutation burden was higher, and PI3K, DNA damage repair, MAPK, and WNT/β-Catenin signaling pathways were enriched in germline and somatic mutations in cases with pCR.
","[{'ForeName': 'Kim R M', 'Initials': 'KRM', 'LastName': 'Blenman', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Marczyk', 'Affiliation': 'Breast Medical Oncology, Yale Cancer Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Qing', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Computational Biology & Bioinformatics, Biological & Biomedical Sciences, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Gunasekharan', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Vesal', 'Initials': 'V', 'LastName': 'Yaghoobi', 'Affiliation': 'Department of Pathology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Yalai', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Pathology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eiman Y', 'Initials': 'EY', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Pharmacology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Tristen', 'Initials': 'T', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Silber', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Wolf', 'Affiliation': 'Department of Laboratory Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Reisenbichler', 'Affiliation': 'Department of Pathology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'University Hospital of Giessen and Marburg, Marburg, Germany.'}, {'ForeName': 'Bruno V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Rozenblit', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Foldi', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Rimm', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Section of Medical Oncology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-3215']
732,35380740,Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies.,"Tofacitinib is an oral small molecule JAK inhibitor for the treatment of ulcerative colitis. Relationships between plasma tofacitinib concentration and efficacy were characterized using exposure-response (E-R) models, with demographic and disease covariates evaluated as potential predictors of efficacy. Data were from phase II and III (OCTAVE Induction 1 and 2) induction studies, and a phase III maintenance study (OCTAVE Sustain). Induction studies included 1,355 patients (tofacitinib 0.5, 3, 10, or 15 mg b.i.d. or placebo). The maintenance study included 592 patients (tofacitinib 5 or 10 mg b.i.d. or placebo). E-R models, including induction patients predicted placebo-adjusted remission rates of 6.4% and 12.7% at week 8 for tofacitinib 5 and 10 mg b.i.d., respectively; corresponding rates in patients without prior tumor necrosis factor inhibitor (TNFi) failure were 12.8% and 20.4%. Estimates to achieve/maintain remission at week 52 of maintenance were 29% and 18% (tofacitinib 5 mg b.i.d.), and 41% and 26% (tofacitinib 10 mg b.i.d.), for patients in remission or not following induction, respectively. During maintenance, patients with prior TNFi failure had lower probability of remission on 5 mg b.i.d. (24.9%) than 10 mg b.i.d. (35.0%). Results indicated tofacitinib 10 mg b.i.d. was an appropriate induction dose but suggested efficacy with 5 mg b.i.d. in patients without prior TNFi failure. Tofacitinib 5 mg b.i.d. was efficacious for maintenance, although patients with prior TNFi failure might see additional benefit on 10 mg b.i.d. Per product labeling, recommended tofacitinib induction dose is 10 mg b.i.d., then maintenance at 5 mg b.i.d. For patients who lose response during maintenance, 10 mg b.i.d. may be considered, limited to the shortest duration. Clinicaltrials.gov: NCT00787202; NCT01465763; NCT01458951; and NCT01458574.",2022,"Tofacitinib 5mg BID was efficacious for maintenance, although patients with prior TNFi failure might see additional benefit on 10mg BID.","['592 patients', 'patients without prior TNFi failure', 'Moderate to Severe Ulcerative Colitis', '1,355\xa0patients (tofacitinib 0.5, 3, 10, or 15mg twice daily [BID], or']","['placebo', 'tofacitinib 5 or 10mg BID, or placebo', 'Tofacitinib']","['placebo-adjusted remission rates', 'probability of remission', 'maintain remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",592.0,0.196378,"Tofacitinib 5mg BID was efficacious for maintenance, although patients with prior TNFi failure might see additional benefit on 10mg BID.","[{'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Tsuchiwata', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Nicholas', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Modesto', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'Chinyu', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California, San Diego, La Jolla, California, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2601']
733,35384422,Fluvoxamine Treatment of Patients with Symptomatic COVID-19 in a Community Treatment Center: A Preliminary Result of Randomized Controlled Trial.,"BACKGROUND


This study aimed to evaluate whether fluvoxamine reduces clinical deterioration in adult patients with mild to moderate coronavirus disease 2019 (COVID-19), and to identify risk factors for clinical deterioration in patients admitted to a community treatment center (CTC).
MATERIALS AND METHODS


A randomized, placebo-controlled trial was conducted in a CTC, in Seoul, Korea from January 15, 2021, to February 19, 2021. Symptomatic adult patients with positive results of severe acute respiratory syndrome coronavirus 2 real time-polymerase chain reaction within 3 days of randomization were assigned at random to receive 100 mg of fluvoxamine or placebo twice daily for 10 days. The primary outcome was clinical deterioration defined by any of the following criteria: oxygen requirement to keep oxygen saturation over 94.0%, aggravation of pneumonia with dyspnea, or World Health Organization clinical progression scale 4 or greater.
RESULTS


Of 52 randomized participants [median (interquartile range) age, 53.5 (43.3 - 60.0) years; 31 (60.0%) men], 44 (85.0%) completed the trial. Clinical deterioration occurred in 2 of 26 patients in each group ( P  >0.99). There were no serious adverse events in either group. Clinical deterioration occurred in 15 (6.0%) of 271 patients admitted to the CTC, and all of them were transferred to a hospital. In multivariate analysis, age between 55 and 64, fever and pneumonia at admission were independent risk factors for clinical deterioration.
CONCLUSION


In this study of adult patients with symptomatic COVID-19 who were admitted to the CTC, there was no significant differences in clinical deterioration between patients treated with fluvoxamine and placebo (ClinicalTrials.gov Identifier: NCT04711863).",2022,Clinical deterioration occurred in 2 of 26 patients in each group ( P  >0.99).,"['a CTC, in Seoul, Korea from January 15, 2021, to February 19, 2021', '31 (60.0%) men], 44 (85.0%) completed the trial', 'patients admitted to a community treatment center (CTC', 'adult patients with mild to moderate coronavirus disease 2019 (COVID-19', 'adult patients with symptomatic COVID-19 who were admitted to the CTC', 'Symptomatic adult patients with positive results of severe acute respiratory syndrome coronavirus 2 real time-polymerase chain reaction within 3 days of randomization', 'Of 52 randomized participants [median (interquartile range) age, 53.5 (43.3 - 60.0) years', 'Patients with Symptomatic COVID-19 in a Community Treatment Center']","['fluvoxamine and placebo', 'Fluvoxamine', 'fluvoxamine or placebo', 'placebo', 'fluvoxamine']","['aggravation of pneumonia with dyspnea, or World Health Organization clinical progression scale 4 or greater', 'clinical deterioration defined by any of the following criteria: oxygen requirement to keep oxygen saturation', 'serious adverse events', 'clinical deterioration', 'Clinical deterioration']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0085228', 'cui_str': 'Fluvoxamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",271.0,0.645185,Clinical deterioration occurred in 2 of 26 patients in each group ( P  >0.99).,"[{'ForeName': 'Hyeonji', 'Initials': 'H', 'LastName': 'Seo', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Haein', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seongman', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seonghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyemin', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Heung-Sup', 'Initials': 'HS', 'LastName': 'Sung', 'Affiliation': 'Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Han', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Oh', 'Initials': 'SO', 'LastName': 'Lee', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yang Soo', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ki Young', 'Initials': 'KY', 'LastName': 'Son', 'Affiliation': 'Department of Family Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong Pil', 'Initials': 'YP', 'LastName': 'Chong', 'Affiliation': 'Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. drchong@amc.seoul.kr.'}]",Infection & chemotherapy,['10.3947/ic.2021.0142']
734,35389229,Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials.,"BACKGROUND


Extended thromboprophylaxis has not been widely implemented in acutely ill medical patients because of bleeding concerns. The MAGELLAN (Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin) and MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) trials evaluated whether rivaroxaban compared with enoxaparin or placebo could prevent venous thromboembolism without increased bleeding. We hypothesized that patients with major bleeding but not those with nonmajor clinically relevant bleeding would be at an increased risk of all-cause mortality (ACM).
METHODS


We evaluated all bleeding events in patients taking at least 1 dose of study drug and their association with ACM in 4 mutually exclusive groups: (1) no bleeding, or first event was (2) nonmajor clinically relevant bleeding, (3) major bleeding, or (4) trivial bleeding. Using a Cox proportional hazards model adjusted for differences in baseline characteristics associated with ACM, we assessed the risk of ACM after such events.
RESULTS


Compared with patients with no bleeding, the risk of ACM for patients with nonmajor clinically relevant bleeding was not increased in MARINER (hazard ratio, 0.43;  P =0.235) but was increased in MAGELLAN (hazard ratio, 1.74;  P =0.021). Major bleeding was associated with a higher incidence of ACM in both studies, whereas trivial bleeding was not associated with ACM in either study.
CONCLUSIONS


Patients with major bleeding had an increased risk of ACM, whereas nonmajor clinically relevant bleeding was not consistently associated with an increased risk of death. These results inform the risk-benefit calculus of extended thromboprophylaxis in medically ill patients.
REGISTRATION


URL: https://www.
CLINICALTRIALS


gov; Unique identifier: MAGELLAN, NCT00571649. URL: https://www.
CLINICALTRIALS


gov; Unique identifier: MARINER, NCT02111564.",2022,"Compared to patients with no bleeding, the risk of ACM for patients with NMCRB was not increased in MARINER (HR 0.43, p=0.235) but was increased in MAGELLAN (HR 1.74 p=0.021).","['medically ill patients', 'patients taking at least one dose of study drug and their association with ACM in 4 mutually exclusive groups: (1) no bleeding, or first event was (2) NMCRB, (3) MB, or (4) trivial bleeding', 'acutely ill medical patients due to bleeding concerns', 'Medically Ill Patients', 'Patients with MB', 'patients with major bleeding (MB']","['rivaroxaban', 'enoxaparin or placebo']","['risk of ACM', 'venous thromboembolism (VTE', 'trivial bleeding', 'risk of death', 'bleeding events']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001143', 'cui_str': 'Aclarubicin'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",4.0,0.14638,"Compared to patients with no bleeding, the risk of ACM for patients with NMCRB was not increased in MARINER (HR 0.43, p=0.235) but was increased in MAGELLAN (HR 1.74 p=0.021).","[{'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Spyropoulos', 'Affiliation': 'Feinstein Institute for Medical Research, Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York (A.C.S.).'}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Raskob', 'Affiliation': 'Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City (G.E.R.).'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Hematological Medicine, Guy's and St Thomas'/National Health Service Foundation Trust, King's College London, United Kingdom (A.T.C.).""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery, University of Insubria, Varese, Italy (W.A.).'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University, and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.I.W.).'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Bayer US, LLC, Whippany, NJ (T.E.S.).'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Biostatistics Department (W.L.), Janssen Research and Development, LLC, Raritan, NJ.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Lipardi', 'Affiliation': 'Cardiovascular Clinical Development, Janssen Research and Development, LLC, Raritan, NJ (C.L., C.S., E.S.B.).'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford Medical Center, Stanford University, Palo Alto, CA (G.W.A.).'}, {'ForeName': 'C Gregory', 'Initials': 'CG', 'LastName': 'Elliott', 'Affiliation': 'Department of Medicine, University of Utah and Intermountain Healthcare, Salt Lake City (C.G.E.).'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Halperin', 'Affiliation': 'Cardiovascular Institute, Mount Sinai Medical Center, New York (J.L.H.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, and CPC Clinical Research, Aurora (W.R.H.).'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Maynard', 'Affiliation': 'University of California at Davis, Sacramento (G.M.).'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, INSERM UMR-1148 F-75018 Paris, and Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France (P.G.S.).'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Sugarmann', 'Affiliation': 'Cardiovascular Clinical Development, Janssen Research and Development, LLC, Raritan, NJ (C.L., C.S., E.S.B.).'}, {'ForeName': 'Elliot S', 'Initials': 'ES', 'LastName': 'Barnathan', 'Affiliation': 'Cardiovascular Clinical Development, Janssen Research and Development, LLC, Raritan, NJ (C.L., C.S., E.S.B.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057847']
735,35377882,A randomized controlled trial of a proportionate universal parenting program delivery model (E-SEE Steps) to enhance child social-emotional wellbeing.,"BACKGROUND


Evidence for parenting programs to improve wellbeing in children under three is inconclusive. We investigated the fidelity, impact, and cost-effectiveness of two parenting programs delivered within a longitudinal proportionate delivery model ('E-SEE Steps').
METHODS


Eligible parents with a child ≤ 8 weeks were recruited into a parallel two-arm, assessor blinded, randomized controlled, community-based, trial with embedded economic and process evaluations. Post-baseline randomization applied a 5:1 (intervention-to-control) ratio, stratified by primary (child social-emotional wellbeing (ASQ:SE-2)) and key secondary (maternal depression (PHQ-9)) outcome scores, sex, and site. All intervention parents received the Incredible Years® Baby Book (IY-B), and were offered the targeted Infant (IY-I)/Toddler (IY-T) program if eligible, based on ASQ:SE-2/PHQ-9 scores. Control families received usual services. Fidelity data were analysed descriptively. Primary analysis applied intention to treat. Effectiveness analysis fitted a marginal model to outcome scores. Cost-effectiveness analysis involved Incremental Cost-Effectiveness Ratios (ICERs).
RESULTS


The target sample (N = 606) was not achieved; 341 mothers were randomized (285:56), 322 (94%) were retained to study end. Of those eligible for the IY-I (n = 101), and IY-T (n = 101) programs, 51 and 21 respectively, attended. Eight (of 14) groups met the 80% self-reported fidelity criteria. No significant differences between arms were found for adjusted mean difference scores; ASQ:SE-2 (3.02, 95% CI: -0.03, 6.08, p = 0.052), PHQ-9 (-0.61; 95% CI: -1.34, 0.12, p = 0.1). E-SEE Steps had higher costs, but improved mothers' Health-related Quality of Life (0.031 Quality Adjusted Life Year (QALY) gain), ICER of £20,062 per QALY compared to control. Serious adverse events (n = 86) were unrelated to the intervention.
CONCLUSIONS


E-SEE Steps was not effective, but was borderline cost-effective. The model was delivered with varying fidelity, with lower-than-expected IY-T uptake. Changes to delivery systems and the individual programs may be needed prior to future evaluation.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number: ISRCTN11079129.",2022,"E-SEE Steps had higher costs, but improved mothers' Health-related Quality of Life (0.031 Quality Adjusted Life Year (QALY) gain), ICER of £20,062 per QALY compared to control.","['The target sample (N = 606) was not achieved; 341 mothers were randomized (285:56), 322 (94%) were retained to study end', 'Eligible parents with a child ≤ 8 weeks', 'Eight (of 14']","['proportionate universal parenting program delivery model (E-SEE Steps', 'usual services']","[""mothers' Health-related Quality of Life"", 'PHQ-9', 'Serious adverse events', 'fidelity, impact, and cost-effectiveness', 'Incremental Cost-Effectiveness Ratios (ICERs', 'child social-emotional wellbeing', 'key secondary (maternal depression (PHQ-9)) outcome scores, sex, and site']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",86.0,0.159621,"E-SEE Steps had higher costs, but improved mothers' Health-related Quality of Life (0.031 Quality Adjusted Life Year (QALY) gain), ICER of £20,062 per QALY compared to control.","[{'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Bywater', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Vashti', 'Initials': 'V', 'LastName': 'Berry', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, Devon, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blower', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bursnall', 'Affiliation': 'Sheffield Clinical Trials Research Unit, Sheffield, South Yorkshire, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Centre for Health Economics, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mason-Jones', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'McGilloway', 'Affiliation': 'Centre for Mental Health and Community Research, Maynooth University, Maynooth, Co Kildare, Ireland.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'McKendrick', 'Affiliation': 'Sheffield Clinical Trials Research Unit, Sheffield, South Yorkshire, United Kingdom.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Mitchell', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, Devon, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pickett', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Kiera', 'Initials': 'K', 'LastName': 'Solaiman', 'Affiliation': 'Sheffield Clinical Trials Research Unit, Sheffield, South Yorkshire, United Kingdom.'}, {'ForeName': 'M Dawn', 'Initials': 'MD', 'LastName': 'Teare', 'Affiliation': 'Institute of Health and Society University, Newcastle upon Tyne, Tyne and Wear, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Centre for Health Economics, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Whittaker', 'Affiliation': 'School of Nursing, University of Central Lancashire, Preston, Lancashire, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0265200']
736,35394898,Effects of maternal antibodies in infants on the immunogenicity and safety of inactivated polio vaccine in infants.,"The presence of maternal poliovirus antibodies may interfere with the immune response to inactivated polio vaccine (IPV), and its influence on the safety of vaccination is not yet understood. A total of 1146 eligible infants were randomly assigned (1:1) to the IPV and Sabin IPV (SIPV) groups to compare and analyze the efficacy of the two vaccines in preventing poliovirus infection. We pooled the SIPV and IPV groups and reclassified them into the maternal poliovirus antibody-positive group (MAPG; ≥1: 8) and the maternal poliovirus antibody-negative group (MANG; <1: 8). We evaluated the impact of maternal poliovirus antibodies by comparing the geometric mean titer (GMT), seroconversion rate, and geometric mean increase (GMI) of types I-III poliovirus neutralizing antibodies post-vaccination, and incidence rates of adverse reactions following vaccination between the MAPG and MANG. Respective seroconversion rates in the MAPG and MANG were 94% and 100%, 79.27% and 100%, and 93.26% and 100% (all serotypes,  P  < .01) for types I-III poliovirus, respectively. The GMT of all types of poliovirus antibodies in the MAPG (1319.13, 219.91, 764.11, respectively) were significantly lower than those in the MANG (1584.92, 286.73, 899.59, respectively) ( P  < .05). The GMI in the MAPG was significantly lower than that in the MANG ( P  < .05). No statistically significant difference in the incidence of local and systemic adverse reactions was observed between the MAPG and MANG. Thus, the presence of maternal poliovirus antibodies does not affect the safety of IPV but can negatively impact the immune responses in infants after IPV vaccination.",2022,The GMI in the MAPG was significantly lower than that in the MANG ( P  < .05).,"['infants', '1146 eligible infants']","['inactivated polio vaccine', 'Sabin IPV (SIPV', 'maternal poliovirus antibody-negative group (MANG', 'IPV']","['incidence of local and systemic adverse reactions', 'geometric mean titer (GMT), seroconversion rate, and geometric mean increase (GMI) of types I-III poliovirus neutralizing antibodies post-vaccination, and incidence rates of adverse reactions', 'immunogenicity and safety', 'maternal poliovirus antibodies', 'poliovirus infection', 'GMI in the MAPG', 'Respective seroconversion rates']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0855852', 'cui_str': 'Antibody NOS negative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",1146.0,0.0615792,The GMI in the MAPG was significantly lower than that in the MANG ( P  < .05).,"[{'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'School of Public Health, Southeast University, Nanjing, PR China.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Vaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Vaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Jingxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Vaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'School of Public Health, Southeast University, Nanjing, PR China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2050106']
737,35385480,Early initiation of rivaroxaban after reperfusion therapy for stroke patients with nonvalvular atrial fibrillation.,"BACKGROUND


The optimal timing of initiating oral anticoagulants after reperfusion therapy for ischemic stroke is unknown. Factors related to early initiation of rivaroxaban and differences in clinical outcomes of stroke patients with nonvalvular atrial fibrillation (NVAF) who underwent reperfusion therapy was investigated.
METHODS


From data of 1,333 NVAF patients with ischemic stroke or transient ischemic attack (TIA) in a prospective multicenter study, patients who started rivaroxaban after intravenous thrombolysis and/or mechanical thrombectomy were included. The clinical outcomes included the composite of ischemic events (recurrent ischemic stroke, TIA, or systemic embolism) and major bleeding at 3 months.
RESULTS


Among the 424 patients, the median time from index stroke to starting rivaroxaban was 3.2 days. On multivariable logistic regression analysis, infarct size (odds ratio [OR], 0.99; 95%CI, 0.99-1.00) was inversely and successful reperfusion (OR, 2.13; 95%CI, 1.24-3.72) was positively associated with initiation of rivaroxaban within 72 hours. 205 patients were assigned to the early group (< 72 hours) and 219 patients (≥ 72 hours) to the late group. Multivariable Cox regression models showed comparable hazard ratios between the two groups at 3 months for ischemic events (hazard ratio [HR], 0.18; 95%CI, 0.03-1.32) and major bleeding (HR, 1.80; 95%CI, 0.24-13.54).
CONCLUSIONS


Infarct size and results of reperfusion therapy were associated with the timing of starting rivaroxaban. There were no significant differences in the rates of ischemic events and major bleeding between patients after reperfusion therapy who started rivaroxaban < 72 hours and ≥ 72 hours after the index stroke.
CLINICAL TRIAL REGISTRATION


Unique identifier: NCT02129920; URL: https://www.clinicaltrials.gov.",2022,"The clinical outcomes included the composite of ischemic events (recurrent ischemic stroke, TIA, or systemic embolism) and major bleeding at 3 months.
","['205 patients were assigned to the early group (< 72 hours) and 219 patients (≥ 72 hours) to the late group', 'after intravenous thrombolysis and/or mechanical thrombectomy were included', 'stroke patients with nonvalvular atrial fibrillation (NVAF) who underwent', 'stroke patients with nonvalvular atrial fibrillation', '1,333 NVAF patients with ischemic stroke or transient ischemic attack (TIA']","['rivaroxaban', 'reperfusion therapy']","['rates of ischemic events and major bleeding', 'median time from index stroke', 'major bleeding', 'composite of ischemic events (recurrent ischemic stroke, TIA, or systemic embolism) and major bleeding at 3 months', 'successful reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",1333.0,0.145027,"The clinical outcomes included the composite of ischemic events (recurrent ischemic stroke, TIA, or systemic embolism) and major bleeding at 3 months.
","[{'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Koge', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamagami', 'Affiliation': 'Department of Stroke Neurology, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yasaka', 'Affiliation': 'Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center, Clinical Research Institute, Fukuoka, Japan.'}, {'ForeName': 'Teruyuki', 'Initials': 'T', 'LastName': 'Hirano', 'Affiliation': 'Department of Stroke and Cerebrovascular Medicine, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Hamasaki', 'Affiliation': 'The George Washington University Biostatistics Center, Rockville, Maryland, United States of America.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Neurology, Nippon Medical School Tama-Nagayama Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Neurosurgery, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Fujishige', 'Affiliation': 'Department of Neurosurgery, Shinsapporo Neurosurgical Hospital, Sapporo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tempaku', 'Affiliation': 'Department of Neurosurgery, Hokuto Hospital, Obihiro, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'Clinical Research Center for Medicine, Center for Brain and Cerebral Vessels, Sanno Medical Center, International University of Health and Welfare Director, Tokyo, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Mori', 'Affiliation': 'Department of Behavioral Neurology and Neuropsychiatry, United Graduate School of Child Development, Osaka University, Suita, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}]",PloS one,['10.1371/journal.pone.0264760']
738,35385557,Comparison between intrathecal morphine and intravenous patient control analgesia for pain control after video-assisted thoracoscopic surgery: A pilot randomized controlled study.,"BACKGROUND


Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure, but patients may still experience intense pain, especially during the early postoperative period. Intrathecal morphine (ITM) is an effective pain control method that involves a simple maneuver and has a low risk of complications. This study aimed to study the effectiveness of ITM for pain control in patients who undergo VATS.
MATERIALS AND METHODS


A randomized controlled study was conducted who were in ASA classes 1-3, aged over 18 years, and scheduled for elective VATS. Patients were randomized into two groups: the ITM group (n = 19) received a single shot of 0.2 mg ITM before general anesthesia; and the control group (n = 19) received general anesthesia only. For 48 hours after surgery, other than intravenous patient-controlled analgesia (IVPCA) morphine, patients received no sedatives or opioid medications except for 500 mg acetaminophen four times daily orally. Postoperative pain scores and IVPCA morphine used, side effects, sedation at specific time-points, i.e., 1, 6, 12, 24, and 48-hours and overall treatment satisfaction scores were assessed.
RESULTS


Postoperative pain scores (median [IQR]) in ITM group were significantly lower than control group (repeated-measure ANOVA, p = 0.006) and differed at the first (7 [2, 7] vs 8 [6, 9], p = 0.007) and sixth hours (3 [2, 5] vs 5 [5, 7], p = 0.002). The cumulative dose of post-operative morphine (median [IQR]) in ITM group was also lower (6 [3, 20] vs 19 [14, 28], p = 0.006). The incidence of pruritus was significantly higher in ITM group (68.42% vs. 26.32%, p = 0.009). No significant differences in nausea and vomiting, sedation scores, and satisfaction scores were observed between the two groups.
CONCLUSION


ITM could reduce pain scores and opioid consumption after VATS compared to IVPCA-opioids. However, pain scores and opioid consumption still remained high. No difference in patient satisfaction was detected.",2022,"No significant differences in nausea and vomiting, sedation scores, and satisfaction scores were observed between the two groups.
","['patients who undergo VATS', 'pain control after video-assisted thoracoscopic surgery', 'who were in ASA classes 1-3, aged over 18 years, and scheduled for elective VATS']","['acetaminophen', 'general anesthesia only', 'intravenous patient-controlled analgesia (IVPCA) morphine', 'ITM', 'intrathecal morphine and intravenous patient control analgesia', 'single shot of 0.2 mg ITM', 'Intrathecal morphine (ITM', 'Video-assisted thoracoscopic surgery (VATS']","['nausea and vomiting, sedation scores, and satisfaction scores', 'incidence of pruritus', 'Postoperative pain scores and IVPCA morphine used, side effects, sedation at specific time-points, i.e., 1, 6, 12, 24, and 48-hours and overall treatment satisfaction scores', 'Postoperative pain scores', 'patient satisfaction', 'pain scores and opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0654909,"No significant differences in nausea and vomiting, sedation scores, and satisfaction scores were observed between the two groups.
","[{'ForeName': 'Amorn', 'Initials': 'A', 'LastName': 'Vijitpavan', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nussara', 'Initials': 'N', 'LastName': 'Kittikunakorn', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rojnarin', 'Initials': 'R', 'LastName': 'Komonhirun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0266324']
739,35397165,Cardiovascular Benefits of Empagliflozin Are Associated With Gut Microbiota and Plasma Metabolites in Type 2 Diabetes.,"CONTEXT


Cardiovascular benefits of empagliflozin in patients with type 2 diabetes mellitus (T2DM) have been reported; however, the underlying mechanism remains unknown.
OBJECTIVE


We hypothesized that the cardiovascular benefits of empagliflozin are associated with altered gut microbiota and plasma metabolites, and that empagliflozin may be used as an initial treatment for patients with T2DM at risk of cardiovascular diseases (CVDs).
METHODS


This randomized, open-label, 3-month, 2-arm clinical trial included 76 treatment-naïve patients with T2DM and risk factors for CVD who were treated with either empagliflozin (10 mg/d, n = 40) or metformin (1700 mg/d, n = 36). We investigated changes in clinical parameters related to glucose metabolism and CVD risk factors, gut microbiota using 16S rRNA gene sequencing, and plasma metabolites using LC-MS.
RESULTS


We found significant and similar reduction in HbA1c levels and alleviation of glucose metabolism in both groups. However, only empagliflozin improved CVD risk factors. Empagliflozin significantly reshaped the gut microbiota after 1 month of treatment; this alteration was maintained until the end of the trial. Empagliflozin increased the levels of plasma metabolites such as sphingomyelin, but reduced glycochenodeoxycholate, cis-aconitate, and uric acid levels. Concurrently, empagliflozin elevated levels of short-chain fatty acid-producing bacteria such as species from Roseburia, Eubacterium, and Faecalibacterium, and reduced those of several harmful bacteria including Escherichia-Shigella, Bilophila, and Hungatella.
CONCLUSION


Empagliflozin may be a superior initial therapy for patients with T2DM at risk of CVDs; its cardiovascular benefits may be associated with shifts in gut microbiota and plasma metabolites.",2022,"Empagliflozin increased the levels of plasma metabolites such as sphingomyelin, but reduced glycochenodeoxycholate, cis-aconitate, and uric acid levels.","['patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM at risk of CVDs', 'patients with T2DM at risk of cardiovascular diseases (CVDs', 'Hospital', 'Seventy-six treatment-naïve patients with T2DM and risk factors for CVD']","['Empagliflozin', 'metformin', 'empagliflozin']","['gut microbiota', 'gut microbiota and plasma metabolites', 'glucose metabolism and CVD risk factors, gut microbiota using 16S rRNA gene sequencing, and plasma metabolites using LC-MS', 'levels of plasma metabolites such as sphingomyelin, but reduced glycochenodeoxycholate, cis-aconitate, and uric acid levels', 'CVD risk factors', 'HbA1c levels and alleviation of glucose metabolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086355', 'cui_str': 'Glycochenodeoxycholate'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C4048281', 'cui_str': 'aconitate'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.079388,"Empagliflozin increased the levels of plasma metabolites such as sphingomyelin, but reduced glycochenodeoxycholate, cis-aconitate, and uric acid levels.","[{'ForeName': 'Xinru', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Chenhong', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Microbial Metabolism and Ministry of Education Key Laboratory of Systems Biomedicine, School of Life Sciences and Biotechnology, Shanghai Jiao Tong University, Shanghai 200240, China.'}, {'ForeName': 'Pengxu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Junpeng', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Yalei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Yiqi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yuan', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Quane', 'Initials': 'Q', 'LastName': 'Kan', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Man', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Danyu', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""Department of Endocrinology, Henan Provincial Key Medicine Laboratory of Intestinal Microecology and Diabetes, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan 450003, China.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac210']
740,35397159,Inspiratory muscle training in addition to whole body vibration for functional and physical outcomes in pre-frail older women: a randomized controlled trial.,"BACKGROUND


to investigate the efficacy of addition of inspiratory muscle training (IMT) to the whole body vibration (WBV) on functional outcomes, physical performance, muscle strength and metabolism in pre-frail older women.
METHODS


this study was a randomized double-blind trial. Forty-two older women aged 60-80 years who meet the Cardiovascular Health Study frailty criteria for pre-frailty were randomly allocated to IMT + WBV, IMTsham + WBV or Sham groups. IMT + WBV group received 12 weeks of both trainings, whereas IMTsham + WVB received 12 weeks of WBV alone. Sham group received 12 weeks of IMT with a low fixed load and were positioned at the vibratory platform without therapeutic effect. Participants were evaluated before and after the intervention for the following outcomes: 6-min walk test distance (6MWD), balance using Tinetti test, functional mobility using timed up and go test (TUG), handgrip strength (HGS) and peripheral muscle metabolism (glucose and lactate levels).
RESULTS


after the training, both groups IMT + WBV and IMTsham + WBV improved 6MWD [mean percentage changes = 20.31 (SD = 14.62) and 13.02 (SD = 12.14), respectively] compared with Sham [0.27 (SD = 6.51)], P <0.01. There was also a significant decrease of mean percentage changes on time of the TUG for IMT + WBV [-21.87 (SD = 7.87)] and IMTsham + WBV [-11.15 (SD = 13.64)] compared with Sham [-4.25 (SD = 13.25)], P <0.01. IMT + WBV group improved balance when compared with IMTsham + WBV and Sham groups (P <0.05 and < 0.01, respectively). HGS and levels of lactate and glucose were similar between groups.
CONCLUSIONS


the addition of IMT to the WBV was effective to improve functionality, balance and physical performance in pre-frail older women.",2022,"IMT + WBV group improved balance when compared with IMTsham + WBV and Sham groups (P <0.05 and < 0.01, respectively).","['pre-frail older women', 'Forty-two older women aged 60-80\xa0years who meet the Cardiovascular Health Study frailty criteria for pre-frailty']","['IMT', 'inspiratory muscle training (IMT', 'Inspiratory muscle training in addition to whole body vibration', 'IMT\u2009+\u2009WBV, IMTsham\u2009+\u2009WBV or Sham groups', 'IMT\u2009+\u2009WBV']","['functional outcomes, physical performance, muscle strength and metabolism', '6-min walk test distance (6MWD), balance using Tinetti test, functional mobility using timed up and go test (TUG), handgrip strength (HGS) and peripheral muscle metabolism (glucose and lactate levels', 'time of the TUG for IMT\u2009+\u2009WBV', 'HGS and levels of lactate and glucose', '6MWD', 'functionality, balance and physical performance']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",42.0,0.0990683,"IMT + WBV group improved balance when compared with IMTsham + WBV and Sham groups (P <0.05 and < 0.01, respectively).","[{'ForeName': 'Helga Cecília Muniz', 'Initials': 'HCM', 'LastName': 'de Souza', 'Affiliation': 'Postgraduate Program of Biology Applied to Health, Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Maíra Florentino', 'Initials': 'MF', 'LastName': 'Pessoa', 'Affiliation': 'Postgraduate Program of Biology Applied to Health, Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Rafaela', 'Initials': 'R', 'LastName': 'Dos Santos Clemente', 'Affiliation': 'Laboratory of Cardiopulmonary Physiotherapy, Department of Physiotherapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Alanna Vasconcelos', 'Initials': 'AV', 'LastName': 'da Silva', 'Affiliation': 'Laboratory of Cardiopulmonary Physiotherapy, Department of Physiotherapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Erika Alves Marinho', 'Initials': 'EAM', 'LastName': 'de Andrade', 'Affiliation': 'Laboratory of Cardiopulmonary Physiotherapy, Department of Physiotherapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Patrícia Areias Feitosa', 'Initials': 'PAF', 'LastName': 'Neves', 'Affiliation': 'Hospital das Clínicas de Pernambuco, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Fernandes', 'Affiliation': 'Laboratory of Physiotherapy and Collective Health, Department of Physiotherapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Arméle', 'Initials': 'A', 'LastName': 'Dornelas de Andrade', 'Affiliation': 'Postgraduate Program of Biology Applied to Health, Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Age and ageing,['10.1093/ageing/afac083']
741,35398912,Effects of integrative neuromuscular training on the gait biomechanics of children with overweight and obesity.,"OBJECTIVE


To analyze whether 13 weeks of integrative neuromuscular training can benefit spatiotemporal and kinematic parameters of gait in children with overweight/obesity.
METHODS


This is a non-randomized controlled trial. Fifty children (10.77 ± 1.24 years, 31 girls) with overweight/obesity were allocated to an exercise group (EG) (n = 25) that carried out a 13-week exercise program based on fundamental movement skills, strength activities and aerobic training, and a control group (CG) (n = 25) that followed their normal lifestyle. Spatiotemporal (i.e., cadence, stance and support times, step length, and stride width) and kinematic (i.e., hip, pelvis, knee, and ankle angles) parameters were evaluated under laboratory conditions through a 3D analysis. ANCOVA was used to test raw and z-score differences between the EG and CG at post-exercise, adjusting for pre-exercise values.
RESULTS


The EG maintained their baseline stance and single-limb support times while the CG increased them during walking (groups' difference: 3.1 and 1.9 centiseconds). The EG maintained baseline maximum foot abduction angle during the stance phase whereas the CG showed an increase (groups' difference: 3.9º). Additional analyses on kinematic profiles demonstrated that the EG walked with similar pelvic tilt and ankle abduction angles at post-exercise, while the CG increased the pelvic anterior tilt in the whole stance phase (mean groups' difference: 7.7º) and the ankle abduction angles in early- and mid-stance phases (mean groups' difference: 4.6º). No changes were observed in the rest of spatiotemporal and kinematic parameters.
CONCLUSIONS


The integrative neuromuscular training stopped the progression of some biomechanical alterations during walking in children with overweight/obesity. These findings could contribute to preventing common movement-derived musculoskeletal disorders in this population, as well as preserving an optimal mechanical efficiency during walking.",2022,The EG maintained baseline maximum foot abduction angle during the stance phase whereas the CG showed an increase (groups difference: 3.9º).,"['children with overweight/obesity', 'Fifty children (10.77 ± 1.24 years, 31 girls) with overweight/obesity', 'children with overweight and obesity']","['exercise program based on fundamental movement skills, strength activities and aerobic training, and a control group (CG) (n=25) that followed their normal lifestyle', 'Integrative Neuromuscular Training', 'integrative neuromuscular training', 'exercise group (EG']","['Spatiotemporal (i.e., cadence, stance and support times, step length and stride width) and kinematic (i.e., hip, pelvis, knee and ankle angles) parameters', 'ankle abduction angles', 'gait biomechanics', 'EG walked with similar pelvic tilt and ankle abduction angles', 'rest of spatiotemporal and kinematic parameters', 'pelvic anterior tilt']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517496', 'cui_str': '1.24'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",50.0,0.0222133,The EG maintained baseline maximum foot abduction angle during the stance phase whereas the CG showed an increase (groups difference: 3.9º).,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Molina-Garcia', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through PHYSICAL ACTIVITY"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Molina-Molina', 'Affiliation': 'Campus Universitario, Universidad San Jorge, Zaragoza, Spain.'}, {'ForeName': 'Annemie', 'Initials': 'A', 'LastName': 'Smeets', 'Affiliation': 'Musculoskeletal Rehabilitation Research Group, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jairo H', 'Initials': 'JH', 'LastName': 'Migueles', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through PHYSICAL ACTIVITY"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'Ortega', 'Affiliation': 'PROFITH ""PROmoting FITness and Health Through PHYSICAL ACTIVITY"" Research Group, Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Vanrenterghem', 'Affiliation': 'Musculoskeletal Rehabilitation Research Group, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.14163']
742,35398908,Biomechanical adaptations following a music-based biofeedback gait retraining program to reduce peak tibial accelerations.,"PURPOSE


The present study aimed to determine whether runners can reduce impact measures after a six-session in-the-field gait retraining program with real-time musical biofeedback on axial peak tibial acceleration (PTA a  ) and identify the associated biomechanical adaptations.
METHODS


Twenty trained high-impact runners were assigned to either the biofeedback or the music-only condition. The biofeedback group received real-time feedback on the PTA a  during the gait retraining program, whereas the music-only condition received a sham treatment. Three-dimensional gait analysis was conducted in the laboratory before (PRE) and within one week after completing the gait retraining program (POST). Subjects were instructed to replicate the running style from the last gait retraining session without receiving feedback while running overground at a constant speed of 2.9 m∙s -1  .
RESULTS


Only the biofeedback group showed significant reductions in both PTA a  (∆x̅ = -26.9%, p = 0.006) and vertical instantaneous loading rate (∆x̅ = -29.2%, p = 0.003) from PRE to POST. In terms of biomechanical adaptations, two strategies were identified. Two subjects transitioned toward a more forefoot strike. The remaining eight subjects used a pronounced rearfoot strike and posteriorly inclined shank at initial contact combined with less knee extension at toe-off while reducing vertical excursion of the center of mass.
CONCLUSIONS


After completing a music-based biofeedback gait retraining program, runners can reduce impact while running overground in a laboratory. We identified two distinct self-selected strategies used by the participants to achieve reductions in impact.",2022,"Only the biofeedback group showed significant reductions in both PTA a  (∆x̅ = -26.9%, p = 0.006) and vertical instantaneous loading rate (∆x̅ = -29.2%, p = 0.003) from PRE to POST.",['Twenty trained high-impact runners'],"['running style from the last gait retraining session without receiving feedback while running overground at a constant speed of 2.9 m⸳s -1  ', 'music-based biofeedback gait retraining program', 'biofeedback or the music-only condition', 'real-time feedback on the PTA']","['vertical instantaneous loading rate', 'axial peak tibial acceleration (PTA a  ', 'peak tibial accelerations']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}]",20.0,0.0209723,"Only the biofeedback group showed significant reductions in both PTA a  (∆x̅ = -26.9%, p = 0.006) and vertical instantaneous loading rate (∆x̅ = -29.2%, p = 0.003) from PRE to POST.","[{'ForeName': 'Rud', 'Initials': 'R', 'LastName': 'Derie', 'Affiliation': 'Biomechanics and Motor Control of Human Movement, Department of Movement and Sport Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Van den Berghe', 'Affiliation': 'Biomechanics and Motor Control of Human Movement, Department of Movement and Sport Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Joeri', 'Initials': 'J', 'LastName': 'Gerlo', 'Affiliation': 'Biomechanics and Motor Control of Human Movement, Department of Movement and Sport Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Senne', 'Initials': 'S', 'LastName': 'Bonnaerens', 'Affiliation': 'Biomechanics and Motor Control of Human Movement, Department of Movement and Sport Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ine Van', 'Initials': 'IV', 'LastName': 'Caekenberghe', 'Affiliation': 'Biomechanics and Motor Control of Human Movement, Department of Movement and Sport Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Fiers', 'Affiliation': 'Biomechanics and Motor Control of Human Movement, Department of Movement and Sport Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'De Clercq', 'Affiliation': 'Biomechanics and Motor Control of Human Movement, Department of Movement and Sport Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Segers', 'Affiliation': 'Biomechanics and Motor Control of Human Movement, Department of Movement and Sport Sciences, Ghent University, Ghent, Belgium.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.14162']
743,35421962,"Tailored individual Yoga practice improves sleep quality, fatigue, anxiety, and depression in chronic insomnia disorder.","BACKGROUND


Chronic insomnia disorder (CI) is a prevalent sleep disorder that can lead to disturbed daytime functioning and is closely associated with anxiety and depression. First-choice treatment is cognitive behavioral therapy (CBT-I). Other mind-body interventions, such as Tai-chi and Yoga, have demonstrated subjective improvements in sleep quality. The purpose of this study was to assess the efficacy of Yoga for improvement of subjective and objective sleep quality as well as measures of anxiety, depression, sleepiness, and fatigue in patients with CI.
METHODS


Adults with CI were prospectively included in this single group pre-post study. Baseline assessments included home polysomnography (PSG), 7-day actigraphy, and questionnaires (Pittsburgh Sleep Quality Index questionnaire (PSQI), Hospital Anxiety Depression scale (HADS), Epworth Sleepiness Scale (ESS), Pichot fatigue scale (PS)). Patients practiced Viniyoga, an individualised Yoga practice with daily self-administered exercises, for 14 weeks. Assessments were repeated at the end of Yoga practice.
RESULTS


Twenty-one patients completed the study. Objective sleep measurements revealed no change in PSG parameters after Yoga practice, but a decrease in arousals on actigraphy (p < 0.001). Subjective symptoms improved for all questionnaires (PSQI, p < 0.001; HAD-A, p = 0.020, HAD-D, p = 0.001, ESS, p = 0.041, PS, p = 0.010). In univariate correlations, decrease in PSQI was associated with increase in sleep stage N3 (p < 0.001) on PSG.
CONCLUSIONS


We have demonstrated a positive impact of individualized Yoga practice on subjective parameters related to sleep and daytime symptoms in CI, resulting in fewer arousals on actigraphy. Yoga could be proposed as a potentially useful alternative to CBT-I in CI, as it is easy to practice autonomously over the long-term. However, given the design of the present study, future prospective controlled studies should first confirm our results.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03314441 , date of registration: 19/10/2017.",2022,"Subjective symptoms improved for all questionnaires (PSQI, p < 0.001; HAD-A, p = 0.020, HAD-D, p = 0.001, ESS, p = 0.041, PS, p = 0.010).","['Twenty-one patients completed the study', 'patients with CI.\nMETHODS\n\n\nAdults with CI', 'Chronic insomnia disorder (CI']",['cognitive behavioral therapy (CBT-I'],"['PSG parameters', 'anxiety, depression, sleepiness, and fatigue', 'PSQI', 'Subjective symptoms', 'arousals on actigraphy', 'home polysomnography (PSG), 7-day actigraphy, and questionnaires (Pittsburgh Sleep Quality Index questionnaire (PSQI), Hospital Anxiety Depression scale (HADS), Epworth Sleepiness Scale (ESS), Pichot fatigue scale (PS', 'sleep stage N3', 'sleep quality, fatigue, anxiety, and depression in chronic insomnia disorder', 'subjective and objective sleep quality']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0451107', 'cui_str': 'Depression anxiety scale'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",21.0,0.0336805,"Subjective symptoms improved for all questionnaires (PSQI, p < 0.001; HAD-A, p = 0.020, HAD-D, p = 0.001, ESS, p = 0.041, PS, p = 0.010).","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Turmel', 'Affiliation': 'Viniyoga, Brussels, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Carlier', 'Affiliation': 'Department of Pulmonary Medicine, CHU Saint-Pierre, Brussels, Belgium and Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Anne Violette', 'Initials': 'AV', 'LastName': 'Bruyneel', 'Affiliation': 'Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bruyneel', 'Affiliation': 'Department of Pulmonary Medicine, CHU Saint-Pierre, Brussels, Belgium and Université Libre de Bruxelles (ULB), Brussels, Belgium. Marie_Bruyneel@stpierre-bru.be.'}]",BMC psychiatry,['10.1186/s12888-022-03936-w']
744,35428608,Editorial for A randomized controlled trial of sleep study surveillance with targeted autoregulated positive airway pressure therapy for obstructive sleep apnea in pregnancy.,,2022,,['obstructive sleep apnea in pregnancy'],['targeted autoregulated positive airway pressure therapy'],[],"[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.108285,,"[{'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Facco', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA (Dr Facco). Electronic address: faccof@upmc.edu.'}, {'ForeName': 'Sanjay R', 'Initials': 'SR', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Center for Sleep and Cardiovascular Outcomes Research, University of Pittsburgh School of Medicine, Pittsburgh, PA (Dr Patel).'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH (Dr Grobman).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100602']
745,35429294,Fast and ballistic contractions involve greater neuromuscular power production in older adults during resistance exercise.,"PURPOSE


Neuromuscular power is critical for healthy ageing. Conventional older adult resistance training (RT) guidelines typically recommend lifting slowly (2-s; CONV), whereas fast/explosive contractions performed either non-ballistically (FAST-NB) or ballistically (FAST-B, attempting to throw the load) may involve greater acute power production, and could ultimately provide a greater chronic power adaptation stimulus. To compare the neuromechanics (power, force, velocity, and muscle activation) of different types of concentric isoinertial RT contractions in older adults.
METHODS


Twelve active older adult males completed three sessions, each randomly assigned to one type of concentric contraction (CONV or FAST-NB or FAST-B). Each session involved lifting a range of loads (20-80%1RM) using an instrumented isoinertial leg press dynamometer that measured power, force, and velocity. Muscle activation was assessed with surface electromyography (sEMG).
RESULTS


Peak and mean power were markedly different, according to the concentric contraction explosive intent FAST-B > FAST-NB > CONV, with FAST-B producing substantially more power (+ 49 to 1172%, P ≤ 0.023), force (+ 10 to 136%, P < 0.05) and velocity (+ 55 to 483%, P ≤ 0.025) than CONV and FAST-NB contractions. Knee and hip extensor sEMG were typically higher during FAST-B than CON (all P < 0.02) and FAST-NB (≤ 50%1RM, P ≤ 0.001).
CONCLUSIONS


FAST-B contractions produced markedly greater power, force, velocity and muscle activation across a range of loads than both CONV or FAST-NB and could provide a more potent RT stimulus for the chronic development of older adult power.",2022,"Knee and hip extensor sEMG were typically higher during FAST-B than CON (all P < 0.02) and FAST-NB (≤ 50%1RM, P ≤ 0.001).
","['older adults during resistance exercise', 'older adults', 'Twelve active older adult males', 'healthy ageing']","['concentric contraction (CONV or FAST-NB or FAST-B', 'Conventional older adult resistance training (RT', 'Fast and ballistic contractions']","['power, force, velocity and muscle activation', 'neuromechanics (power, force, velocity, and muscle activation', 'velocity', 'Knee and hip extensor sEMG', 'Muscle activation', 'Peak and mean power']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0443149', 'cui_str': 'Ballistic'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",12.0,0.0190562,"Knee and hip extensor sEMG were typically higher during FAST-B than CON (all P < 0.02) and FAST-NB (≤ 50%1RM, P ≤ 0.001).
","[{'ForeName': 'Emmet J', 'Initials': 'EJ', 'LastName': 'Mc Dermott', 'Affiliation': 'Versus Arthritis, Centre for Sport, Exercise and Osteoarthritis Research, Loughborough University, Leicestershire, UK.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Balshaw', 'Affiliation': 'Versus Arthritis, Centre for Sport, Exercise and Osteoarthritis Research, Loughborough University, Leicestershire, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Brooke-Wavell', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Maden-Wilkinson', 'Affiliation': 'Physical Activity, Wellness and Public Health Research Group, Department of Sport and Physical Activity, Faculty of Health and Wellbeing, Collegiate Campus, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Folland', 'Affiliation': 'Versus Arthritis, Centre for Sport, Exercise and Osteoarthritis Research, Loughborough University, Leicestershire, UK. J.P.Folland@lboro.ac.uk.'}]",European journal of applied physiology,['10.1007/s00421-022-04947-x']
746,35430328,Effect of Aspirin on CKD Progression in Older Adults: Secondary Analysis From the ASPREE Randomized Clinical Trial.,,2022,,['Older Adults'],['Aspirin'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]",[],,0.493973,,"[{'ForeName': 'Kevan R', 'Initials': 'KR', 'LastName': 'Polkinghorne', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia; Department of Nephrology, Monash Medical Centre, Monash Health, Melbourne, Victoria, Australia. Electronic address: kevan.polkinghorne@monash.edu.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Wetmore', 'Affiliation': 'Division of Nephrology, Department of Medicine, Hennepin Healthcare, Minneapolis, Minnesota.'}, {'ForeName': 'Le Thi Phuong', 'Initials': 'LTP', 'LastName': 'Thao', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; School of Population Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Department of Medicine, Division of Geriatrics, Hennepin Healthcare, Minneapolis, Minnesota; Hennepin Healthcare Research Institute, Minneapolis, Minnesota.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2022.02.019']
747,35431132,"The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial.","OBJECTIVES


Neoadjuvant chemotherapy and radical cystectomy (RC) are underutilized standards of care for the treatment of muscle-invasive bladder cancer (MIBC) due to high patient burden from systemic toxicities and postoperative complications, respectively. TAR-200 is a novel intravesical drug delivery system developed to release gemcitabine into the bladder urine continuously, resulting in distribution of drug into stromal layers of the bladder. The primary aim of the TAR-200-101 study was to evaluate the safety of TAR-200 in patients with MIBC prior to RC (NCT02722538).
METHODS AND MATERIALS


This phase I, open-label study was conducted across 6 US and European sites. Eligible patients were aged ≥18 years with histologically confirmed T2a-T3b N0-N1 M0 urothelial cancer and had refusal or were ineligible to receive cisplatin-based combination chemotherapy. Two arms were enrolled serially. Patients in Arm 1 had residual tumor >3 cm after transurethral resection of bladder tumor (TURBT); those in Arm 2 had undergone maximal TURBT (residual tumor <3 cm). Patients received two 7-day cycles of intravesical gemcitabine delivery via TAR-200 before undergoing RC. Primary outcome was safety; secondary outcomes were tolerability, pharmacokinetics, and preliminary efficacy.
RESULTS


Of 23 patients in the intention-to-treat population (11 in Arm 1, 12 in Arm 2), 20 completed both dosing cycles of TAR-200. No patients were classified as intolerant to TAR-200. Ten patients (4 in Arm 1, 6 in Arm 2) experienced ≥1 treatment-emergent adverse events (TEAEs). The most common TAR-200-related TEAEs were pollakiuria (n = 3) and urinary incontinence (n = 2). All TEAEs prior to RC were grade ≤2; 1 patient in Arm 2 experienced a grade 3 non-treatment-related TEAE. Plasma gemcitabine levels were undetectable. In Arm 1, those with residual tumor, 4 of 10 patients exhibited pathologic downstaging; 1 experienced a complete response (CR) and 3 a partial response (PR). In Arm 2, those undergoing maximal TURBT, 6 of 10 patients exhibited downstaging; 3 experienced a CR and 3 a PR.
CONCLUSION


Controlled intravesical gemcitabine release via TAR-200 was safe and well tolerated in patients with MIBC.",2022,All TEAEs prior to RC were grade ≤2; 1 patient in Arm 2 experienced a grade 3 non-treatment-related TEAE.,"['patients with MIBC prior to RC (NCT02722538', 'patients with MIBC', 'muscle-invasive bladder cancer (MIBC', 'Eligible patients were aged ≥18 years with histologically confirmed T2a-T3b N0-N1 M0 urothelial cancer and had refusal or were ineligible to receive', 'muscle-invasive bladder cancer patients']","['Neoadjuvant chemotherapy and radical cystectomy (RC', 'cisplatin-based combination chemotherapy', 'intravesical gemcitabine', 'neoadjuvant gemcitabine intravesical drug delivery system (TAR-200', 'TAR-200']","['safety, tolerability, and efficacy', 'safety of TAR-200', '≥1 treatment-emergent adverse events (TEAEs', 'tolerability, pharmacokinetics, and preliminary efficacy', 'complete response (CR) and 3 a partial response (PR', 'Plasma gemcitabine levels', 'urinary incontinence', 'pathologic downstaging']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0475387', 'cui_str': 'Tumor stage T2a'}, {'cui': 'C0475391', 'cui_str': 'Tumor stage T3b'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039315', 'cui_str': 'Tar'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039315', 'cui_str': 'Tar'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}]",,0.0529443,All TEAEs prior to RC were grade ≤2; 1 patient in Arm 2 experienced a grade 3 non-treatment-related TEAE.,"[{'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Daneshmand', 'Affiliation': 'Department of Urology, University of Southern California Keck School of Medicine, Norris Comprehensive Cancer Center, Los Angeles, CA. Electronic address: daneshma@med.usc.edu.'}, {'ForeName': 'Iris S G', 'Initials': 'ISG', 'LastName': 'Brummelhuis', 'Affiliation': 'Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Kamal S', 'Initials': 'KS', 'LastName': 'Pohar', 'Affiliation': 'Department of Urology, College of Medicine, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Steinberg', 'Affiliation': 'Department of Urology, NYU Langone Health, New York, NY.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Aron', 'Affiliation': 'Department of Pathology, University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutie', 'Affiliation': 'Janssen Research & Development, Lexington, MA.'}, {'ForeName': 'Kirk A', 'Initials': 'KA', 'LastName': 'Keegan', 'Affiliation': 'Janssen Research & Development, Lexington, MA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Maffeo', 'Affiliation': 'Janssen Research & Development, Lexington, MA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Reynolds', 'Affiliation': 'Janssen Research & Development, Lexington, MA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Raybold', 'Affiliation': 'Janssen Research & Development, Spring House, PA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Chau', 'Affiliation': 'Datacision Limited, London, UK.'}, {'ForeName': 'J Alfred', 'Initials': 'JA', 'LastName': 'Witjes', 'Affiliation': 'Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}]",Urologic oncology,['10.1016/j.urolonc.2022.02.009']
748,35393266,Diet and physical activity are associated with suboptimal weight loss and weight regain 10-15 years after Roux-en-Y gastric bypass: A cross-sectional study.,"INTRODUCTION


Suboptimal weight loss (SWL) after bariatric surgery affects approximately 30% of the patients in the long-term. Diet and physical activity (PA) are likely to modulate long term weight loss outcomes after Roux-en-Y gastric bypass (RYGB).
OBJECTIVES


To compare food habits and PA levels between those experiencing SWL and optimal weight loss (OWL), and between those experiencing weight regain (WR) and no weight regain (NWR), 10-15 years after RYGB, in addition to a pre-operative control group.
METHODS


Participants were recruited from the Bariatric Surgery Observation Study (BAROBS), ≥ 10 y after RYGB. Food intake was assessed by a Food Frequency Questionnaire (FFQ) and PA levels with Sensewear armbands.
RESULTS


75 participants (79% females) were recruited. Excess weight loss (EWL) was 17 ± 19% and 87 ± 22% in the SWL and OWL groups, respectively and WR was 31 ± 15% and 1 ± 11% in the WR and NWR groups, respectively (P < 0.001 for both). The OWL group reported a lower energy intake (P = 0.012) than the control group. The control group reported a higher intake of milk, cream and cheese than both SWL group (P = 0.008) and OWL group (P < 0.001). The SWL group reported a higher intake of processed meat products than the OWL group, while the OWL group reported a lower intake of sauces than both the SWL and the control groups (P < 0.001 and P = 0.005, respectively). The OWL group reported a lower intake of cakes, sugar and sweets than both SWL group (P = 0.035) and control group (P = 0.021). The WR group reported a lower PA duration (P = 0.046) compared with the NWR group. EWL was positively, and WR negatively, correlated with average PA duration.
CONCLUSION


A high intake of energy-dense foods and low PA is associated with poor weight loss outcomes, namely SWL and WR, 10-15 years after RYGB.",2022,"The control group reported a higher intake of milk, cream and cheese than both SWL group (P = 0.008) and OWL group (P < 0.001).","['75 participants (79% females) were recruited', 'Participants were recruited from the Bariatric Surgery Observation Study (BAROBS), ≥\xa010']",['Diet and physical activity (PA'],"['lower intake of cakes, sugar and sweets', 'lower energy intake', 'food habits and PA levels', 'Excess weight loss (EWL', 'Food intake', 'lower PA duration', 'higher intake of milk, cream and cheese', 'higher intake of processed meat products', 'Food Frequency Questionnaire (FFQ) and PA levels', 'optimal weight loss (OWL), and between those experiencing weight regain (WR) and no weight regain (NWR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0452597', 'cui_str': 'Cake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.0358399,"The control group reported a higher intake of milk, cream and cheese than both SWL group (P = 0.008) and OWL group (P < 0.001).","[{'ForeName': 'Siren', 'Initials': 'S', 'LastName': 'Nymo', 'Affiliation': 'Obesity Research Group, Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Nord-Trøndelag Hospital Trust, Clinic of Surgery, Namsos Hospital, Norway; Centre for Obesity and Innovation (ObeCe), Clinic of Surgery, St. Olav University Hospital, Trondheim, Norway. Electronic address: siren.nymo@ntnu.no.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Lundanes', 'Affiliation': 'Obesity Research Group, Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Nord-Trøndelag Hospital Trust, Clinic of Surgery, Namsos Hospital, Norway.'}, {'ForeName': 'Marthe', 'Initials': 'M', 'LastName': 'Aukan', 'Affiliation': 'Obesity Research Group, Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Sandvik', 'Affiliation': 'Centre for Obesity and Innovation (ObeCe), Clinic of Surgery, St. Olav University Hospital, Trondheim, Norway; More-Romsdal Hospital Trust, Department of Medicine, Ålesund Hospital, Norway.'}, {'ForeName': 'Gjermund', 'Initials': 'G', 'LastName': 'Johnsen', 'Affiliation': 'Obesity Research Group, Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Centre for Obesity and Innovation (ObeCe), Clinic of Surgery, St. Olav University Hospital, Trondheim, Norway.'}, {'ForeName': 'Hallvard', 'Initials': 'H', 'LastName': 'Græslie', 'Affiliation': 'Nord-Trøndelag Hospital Trust, Clinic of Surgery, Namsos Hospital, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Larsson', 'Affiliation': 'Regional Obesity Center, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Catia', 'Initials': 'C', 'LastName': 'Martins', 'Affiliation': 'Obesity Research Group, Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Centre for Obesity and Innovation (ObeCe), Clinic of Surgery, St. Olav University Hospital, Trondheim, Norway; Department of Nutrition Sciences, University of Alabama at Birmingham, AL, USA.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2022.03.006']
749,35385522,Application of tight-fitting half-facepiece breath-response powered air-purifying respirator for internal body cooling in occupational environment.,"In dust-generating scenarios in occupational environments, it is important to take measures to prevent not only pneumoconiosis, but also heatstroke. The aim of this study was to verify whether using a tight-fitting half-facepiece breath-response powered air-purifying respirator (PAPR) in combination with a self-produced cooling device could abate the deep body temperature while performing activities. We conducted a crossover study involving 10 subjects. The subjects were subjected to three conditions: wearing a PAPR equipped with a cooling device, PAPR, or a replaceable particulate respirator. During the experiment, the rectal temperature of the subjects was measured, along with the temperature near the PAPR inlet in container with the cooling device when the PAPR equipped with the cooling device was worn. The subjects rested in a cold chamber set at a dry-bulb temperature of 28°C and relative humidity of 45% for 20 min. Then, they moved to a hot chamber set to a dry-bulb temperature of 36°C (with the same relative humidity) in 5 min and exercised on a cycle ergometer for 30 min. After that, the subjects moved to the cold chamber for 5 min and rested for 20 min. Notably, the air inhaled by the subjects wearing PAPR equipped with the cooling device was approximately 10°C cooler than the ambient air. Furthermore, 35 min after the initiation of the experiment (after the middle of the exercise period), the rectal temperature of the participants wearing the PAPR equipped with the cooling device was lower than of those wearing PAPR or replaceable particulate respirators (p <0.05). Thus, we could deduce that the self-produced cooling device was useful in abating deep body temperature. PAPR is useful for its potential applications in hot occupational environments and can save lives in working environments where heat stress can result in major medical complications.",2022,PAPR is useful for its potential applications in hot occupational environments and can save lives in working environments where heat stress can result in major medical complications.,"['occupational environment', '10 subjects']","['PAPR equipped with a cooling device, PAPR, or a replaceable particulate respirator', 'tight-fitting half-facepiece breath-response powered air-purifying respirator', 'tight-fitting half-facepiece breath-response powered air-purifying respirator (PAPR']",['rectal temperature'],"[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0225386', 'cui_str': 'Breath'}]","[{'cui': 'C0489749', 'cui_str': 'Rectal temperature'}]",10.0,0.0381908,PAPR is useful for its potential applications in hot occupational environments and can save lives in working environments where heat stress can result in major medical complications.,"[{'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Sekoguchi', 'Affiliation': 'Department of Work Systems and Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Ando', 'Affiliation': 'Department of Work Systems and Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Ikegami', 'Affiliation': 'Department of Work Systems and Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Yoshitake', 'Affiliation': 'Department of Work Systems and Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Chikage', 'Initials': 'C', 'LastName': 'Nagano', 'Affiliation': 'Department of Health Policy and Management, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ogami', 'Affiliation': 'Department of Work Systems and Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}]",PloS one,['10.1371/journal.pone.0266534']
750,35395758,Assessing and improving public mental health literacy concerning rTMS.,"BACKGROUND


Repetitive transcranial magnetic stimulation (rTMS) has received empirical support as a viable treatment alternative for treatment-resistant major depressive disorder. Nevertheless, patients and the public-at-large may be hesitant to adopt rTMS. In three studies, we sought to (1) assess and (2) improve public perceptions of rTMS as a treatment for depression.
METHODS


In Study 1 (N = 107), we administered questionnaires on Amazon's Mechanical Turk (MTurk) to individuals from the US and Canada in a cross-sectional design to assess perceptions of rTMS compared to psychopharmacology, electroconvulsive therapy (ECT), and talk therapy. In Study 2 (N = 106), we again used an MTurk sample and a cross-sectional design to assess perceptions of rTMS after providing participants with a relatively long description of rTMS. In Study 3 (N = 308), we conducted an experiment in undergraduate students. Participants were randomized to one of four experimental conditions manipulating participants' understanding of the causal mechanisms of depression prior to assessing their perceptions of rTMS.
RESULTS


Public perceptions of rTMS were more negative than pharmacotherapy and talk therapy but not ECT (Study 1). rTMS perceptions were notably better when participants were given thorough information about rTMS procedures, pain, and side-effects (Study 2), compared to the previous study when they were given a very brief description of rTMS. Finally, perceptions of rTMS were significantly better when participants were given a brain circuitry-based causal explanation of depression compared to when they were given a psychological explanation of the causes of depression (Study 3).
CONCLUSIONS


Public perceptions of rTMS are relatively poor. To improve rTMS acceptability, practitioners should carefully consider patients' prior attitudes and beliefs when explaining rTMS as a treatment alternative. Given that beliefs can have powerful effects on treatment outcome (e.g., placebo, nocebo), future research should explore whether rTMS effects on depression can be improved by facilitating less negative perceptions of rTMS.",2022,"rTMS perceptions were notably better when participants were given thorough information about rTMS procedures, pain, and side-effects (Study 2), compared to the previous study when they were given a very brief description of rTMS.",[],"['psychopharmacology, electroconvulsive therapy (ECT), and talk therapy', 'Repetitive transcranial magnetic stimulation (rTMS']",['public perceptions of rTMS'],[],"[{'cui': 'C0033929', 'cui_str': 'Psychopharmacology'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]",,0.0265947,"rTMS perceptions were notably better when participants were given thorough information about rTMS procedures, pain, and side-effects (Study 2), compared to the previous study when they were given a very brief description of rTMS.","[{'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychology, California State University, East Bay, 25800 Carlos Bee Blvd, Hayward, CA, 94542, USA. amanda.morrison@csueastbay.edu.'}, {'ForeName': 'Andero', 'Initials': 'A', 'LastName': 'Uusberg', 'Affiliation': 'Department of Psychology, Stanford University, Building 420, 450 Jane Stanford Way, Stanford, CA, 94305, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': 'Department of Psychology, Stanford University, Building 420, 450 Jane Stanford Way, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Goldenberg', 'Affiliation': 'Harvard Business School, Harvard University, Boston, MA, 02163, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gross', 'Affiliation': 'Department of Psychology, Stanford University, Building 420, 450 Jane Stanford Way, Stanford, CA, 94305, USA.'}]",BMC psychiatry,['10.1186/s12888-022-03880-9']
751,35398760,After thirty years of experience with early postoperative intraperitoneal 5-fluorouracil now saying goodbye.,"In the management of colorectal and appendiceal peritoneal metastases, intraperitoneal 5-fluorouracil (5-FU) has been used in 3 different ways. It has been used as part of an early postoperative intraperitoneal chemotherapy (EPIC) regimen along with EPIC mitomycin C. This EPIC mitomycin C plus EPIC 5-FU has been shown to be equivalent or inferior to HIPEC. Because it is more work intensive than HIPEC and not superior, its use should be abandoned if HIPEC is available. A second way to use intraperitoneal 5-FU is along with HIPEC. Several studies suggest a survival advantage for the combination of HIPEC with EPIC 5-FU. However, patient ineligibility for EPIC 5-FU in high-risk CRS is more likely the cause for the alleged survival advantage attributed to the combination. A third use of intraperitoneal 5-FU is long-term through a peritoneal access device. This plan for 5-FU use has shown favorable results in three randomized controlled studies. Normothermic intraperitoneal chemotherapy (NIPEC) with 5-FU should be considered as a regional chemotherapy component of a randomized trial for prevention or treatment of peritoneal metastases from colorectal or appendiceal cancer. Intravenous oxaliplatin combined with NIPEC 5-FU has been suggested as a bidirectional adjuvant regimen.",2022,mitomycin C. This EPIC mitomycin C plus EPIC 5-FU has been shown to be equivalent or inferior to HIPEC.,"['After thirty years of experience with early postoperative intraperitoneal 5-fluorouracil now saying goodbye', 'peritoneal metastases from colorectal or appendiceal cancer']","['5-FU', 'Intravenous oxaliplatin combined with NIPEC 5-FU', 'Normothermic intraperitoneal chemotherapy (NIPEC) with 5-FU', 'mitomycin C', 'intraperitoneal 5-fluorouracil (5-FU', 'intraperitoneal 5-FU', 'HIPEC with EPIC 5-FU', 'EPIC']",[],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0080151', 'cui_str': 'Simian AIDS'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant neoplasm of peritoneum'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0496779', 'cui_str': 'Malignant tumor of appendix'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",[],,0.021653,mitomycin C. This EPIC mitomycin C plus EPIC 5-FU has been shown to be equivalent or inferior to HIPEC.,"[{'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Sugarbaker', 'Affiliation': 'Washington Cancer Institute, Sugarbaker Oncology, 3629 Fulton St. NW, Washington, DC, 20007, USA. Electronic address: paul.sugarbaker@outlook.com.'}]",Surgical oncology,['10.1016/j.suronc.2022.101757']
752,35403756,Effects of specific collagen peptide supplementation combined with resistance training on Achilles tendon properties.,"The purpose of this study was to investigate the effect of specific collagen peptides (SCP) combined with resistance training (RT) on changes in tendinous and muscular properties. In a randomized, placebo-controlled study, 40 healthy male volunteers (age: 26.3 ± 4.0 years) completed a 14 weeks high-load resistance training program. One group received a daily dosage of 5g SCP while the other group received 5g of a placebo (PLA) supplement. Changes in Achilles tendon cross-sectional area (CSA), tendon stiffness, muscular strength, and thickness of the plantar flexors were measured. The SCP supplementation led to a significantly (p = 0.002) greater increase in tendon CSA (+11.0%) compared with the PLA group (+4.7%). Moreover, the statistical analysis revealed a significantly (p = 0.014) greater increase in muscle thickness in the SCP group (+7.3%) compared with the PLA group (+2.7%). Finally, tendon stiffness and muscle strength increased in both groups, with no statistical difference between the groups. In conclusion, the current study shows that the supplementation of specific collagen peptides combined with RT is associated with a greater hypertrophy in tendinous and muscular structures than RT alone in young physically active men. These effects might play a role in reducing tendon stress (i.e., deposition of collagen in load-bearing structures) during daily activities.",2022,The SCP supplementation led to a significantly (p = 0.002) greater increase in tendon CSA (+11.0%) compared with the PLA group (+4.7%).,"['young physically active men', '40 healthy male volunteers (age: 26.3 ± 4.0 years']","['specific collagen peptide supplementation combined with resistance training', 'PLA', '14-week high-load resistance training program', 'specific collagen peptides (SCP) combined with resistance training (RT', 'placebo (PLA) supplement', 'placebo']","['Achilles tendon cross-sectional area (CSA), tendon stiffness, muscular strength and thickness of the plantar flexors', 'muscle thickness', 'tendon stress', 'Achilles tendon properties', 'tendon CSA', 'tendon stiffness and muscle strength']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",40.0,0.0284784,The SCP supplementation led to a significantly (p = 0.002) greater increase in tendon CSA (+11.0%) compared with the PLA group (+4.7%).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Jerger', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Centner', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Lauber', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Seynnes', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Sohnius', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jendricke', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Oesser', 'Affiliation': 'CRI, Collagen Research Institute GmbH, Kiel, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gollhofer', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'König', 'Affiliation': 'Department for Nutrition, Exercise and Health, Centre of Sports Science, University of Vienna, Vienna, Austria.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.14164']
753,35404709,"Effectiveness of a Telerehabilitative Home Exercise Program on Elder Adults' Physical Performance, Depression and Fear of Falling.","Our aim in this study was to analyze the effects of a home exercise program of calisthenic exercises delivered through telerehabilitation on physical performance, depression, and risk of falling in elder adults. Our participants were elder adults aged 65 and over, divided into exercise and control groups. We initiated a 4-week telerehabilitation calisthenic exercise program in the exercise group following initial assessments, while our control group received no formal exercise training. Both groups were evaluated online before and after this 4-week period with the Geriatric Depression Scale (GDS), Modified Falls Efficacy Scale (MFES), and Short Physical Performance Battery (SPPB). In total, 255 elder adults participated, with 132 (males = 72, females = 60) allocated to calisthenic exercise and 123 (males = 66, females = 57) allocated to the control group. While the groups did not differ significantly on any of our parameters before the exercise, there were statistically significant post-exercise group differences in GDS ( p  ≤ .001) and MFES ( p  ≤ .001) scores related to remarkable physical improvements achieved in the calisthenic exercise group. The exercise group showed significant increases in their scores on the SPPB Balance Test ( p  = .049), SPPB Chair Test ( p  = .009), and SPPB Total ( p  = .002) while there was no significant increase in any of these scores among control group participants ( p  > .05). Thus, calisthenic exercises performed via telerehabilitation significantly improved elder adults' physical performance, fear of falling, and depression. Telerehabilitation is a useful remote means of assessing, inducing, and following-up exercise training, particularly during the ongoing COVID-19 pandemic.",2022,"The exercise group showed significant increases in their scores on the SPPB Balance Test ( p  = .049), SPPB Chair Test ( p  = .009), and SPPB Total ( p  = .002) while there was no significant increase in any of these scores among control group participants ( p  > .05).","['in elder adults', '255 elder adults participated, with 132 (males = 72, females = 60) allocated to', 'Our participants were elder adults aged 65 and over, divided into exercise and control groups', 'and 123 (males = 66, females = 57) allocated to the control group']","['Telerehabilitative Home Exercise Program', 'telerehabilitation calisthenic exercise program', 'home exercise program of calisthenic exercises', 'calisthenic exercise', 'control group received no formal exercise training']","['physical performance, depression, and risk of falling', 'MFES', 'GDS', 'SPPB Total', ""elder adults' physical performance, fear of falling, and depression"", 'Geriatric Depression Scale (GDS), Modified Falls Efficacy Scale (MFES), and Short Physical Performance Battery (SPPB', ""Elder Adults' Physical Performance, Depression and Fear of Falling"", 'SPPB Balance Test', 'SPPB Chair Test']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0006759', 'cui_str': 'Calisthenics'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0179847', 'cui_str': 'Chair'}]",255.0,0.00664212,"The exercise group showed significant increases in their scores on the SPPB Balance Test ( p  = .049), SPPB Chair Test ( p  = .009), and SPPB Total ( p  = .002) while there was no significant increase in any of these scores among control group participants ( p  > .05).","[{'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Tekin', 'Affiliation': '52990Pamukkale University, School of Physical Therapy and Rehabilitation, Denizli, Turkey.'}, {'ForeName': 'Nilufer', 'Initials': 'N', 'LastName': 'Cetisli-Korkmaz', 'Affiliation': '52990Pamukkale University, School of Physical Therapy and Rehabilitation, Denizli, Turkey.'}]",Perceptual and motor skills,['10.1177/00315125221087026']
754,35413905,Post Laparoscopy Pain Reduction Project I (POLYPREP I): intraperitoneal normal saline instillation-a randomised controlled trial.,"OBJECTIVES


To evaluate the effect of intraperitoneal normal saline instillation (INSI) of 15 mL/kg body weight on postoperative pain after a gynaecological laparoscopic procedure.
DESIGN


Randomised controlled trial.
SETTING


University Hospital in Kuala Lumpur, Malaysia.
PARTICIPANTS


Patients aged 18-55 years, with American Society of Anaesthesiologists (ASA) classification I-II, scheduled for an elective gynaecological laparoscopic procedure for a benign cause.
INTERVENTION


The patients were randomly allocated to two groups. In the intervention group, 15 mL/kg body weight of normal saline was instilled intraperitoneally, while the control group received the conventional combination of open laparoscopic trocar valves with gentle abdominal pressure to remove the retained carbon dioxide.
MAIN OUTCOME MEASURES


The outcomes measured were the mean pain scores for shoulder and upper abdominal pain at 24 h, 48 h, and 72 h postoperatively.
RESULTS


A total of 68 women completed the study, including 34 women in each group. There was no difference in the shoulder pain score at 24 h, 48 h, and 72 h postoperatively. However, a significant improvement in the upper abdominal pain score after 48 h (95% confidence interval [CI] 0.34-1.52, p = 0.019) and 72 h (95% CI 0.19-0.26, p = 0.007) postoperatively were observed.
CONCLUSIONS


INSI of 15 mL/kg body weight does not lower postoperative shoulder pain compared to no fluid instillation. A modest pain score improvement was observed in the upper abdominal area at 48 h and 72 h after surgery. An INSI of up to 30 mL/kg body weight may be required to eliminate shoulder pain. Care must be taken before administering a higher amount of INSI, considering the potential risk of peritoneal adhesions. Clinical registration ISRCTN Identifier: 87898051 (Date: 26 June 2019) https://doi.org/10.1186/ISRCTN87898051.",2022,"CONCLUSIONS


INSI of 15 mL/kg body weight does not lower postoperative shoulder pain compared to no fluid instillation.","['68 women completed the study, including 34 women in each group', 'Patients aged 18-55\xa0years, with American Society of Anaesthesiologists (ASA) classification I-II, scheduled for an elective gynaecological laparoscopic procedure for a benign cause', 'University Hospital in Kuala Lumpur, Malaysia']","['conventional combination of open laparoscopic trocar valves with gentle abdominal pressure to remove the retained carbon dioxide', 'Post Laparoscopy Pain Reduction Project I (POLYPREP I): intraperitoneal normal saline instillation', 'intraperitoneal normal saline instillation (INSI) of 15\xa0mL/kg body weight']","['postoperative shoulder pain', 'upper abdominal pain score', 'postoperative pain', 'pain score improvement', 'mean pain scores for shoulder and upper abdominal pain', 'shoulder pain score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3879448', 'cui_str': 'Laparoscopic trocar'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0560714', 'cui_str': 'mL/kg body weight'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0232492', 'cui_str': 'Upper abdominal pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",68.0,0.321214,"CONCLUSIONS


INSI of 15 mL/kg body weight does not lower postoperative shoulder pain compared to no fluid instillation.","[{'ForeName': 'Aizura Syafinaz Ahmad', 'Initials': 'ASA', 'LastName': 'Adlan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jerilee Mariam Khong', 'Initials': 'JMK', 'LastName': 'Azhary', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia. jag23k@yahoo.com.'}, {'ForeName': 'Hairel Zulhamdi Mohd', 'Initials': 'HZM', 'LastName': 'Tarmidzi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Maherah', 'Initials': 'M', 'LastName': 'Kamarudin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Raymond Chung Siang', 'Initials': 'RCS', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Doris Sin Wen', 'Initials': 'DSW', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}]",BMC women's health,['10.1186/s12905-022-01696-z']
755,35416465,Analgesic benefit of metamizole and ibuprofen vs. either medication alone: a randomized clinical trial.,"BACKGROUND


Postoperative pain relief remains a key problem after surgery. Multimodal pain therapy has proven beneficial in alleviating pain to a certain extent. However, when combining non-opioids, the focus has been on NSAIDs and paracetamol, but effects of combined use are only moderate. Metamizole could be a potent adjunct, due to its preclusion in several countries, data on its combined use are sparse, despite its common use in many countries. The aim of this study was to examine whether the combination of metamizole and ibuprofen is superior in relieving postoperative pain to either drug alone.
METHODS


For this randomized, placebo-controlled, cross-over study, 35 patients undergoing bilateral lower third molar extraction were randomized. Each patient received three applications of 1000 mg metamizole + 400 mg ibuprofen for surgery on one side and either 1000 mg metamizole + placebo or 400 mg ibuprofen + placebo on the other side. Pain ratings, rescue-medication (tramadol), and sleep were assessed for 18 hours.
RESULTS


The combined treatment of metamizole and ibuprofen showed lower mean pain scores over 12 hours than ibuprofen (2.4±1.3 vs 3.8±1.6; P=0.005). Further, combined treatment showed lower mean pain scores over 6 hours than ibuprofen (2.0±1.2 vs. 3.1±1.6; P=0.022) or metamizole alone (2.0±1.2 vs. 3.3±1.7; P=0.015). Consumption of rescue medication was lowest in the combination-group (25% vs. 46%-metamizole; 50%-ibuprofen). The trial was stopped prematurely as the COVID-pandemic halted elective surgeries.
CONCLUSIONS


Combined use enables superior pain control compared to ibuprofen after molar extraction and tends to be superior to metamizole alone. The premature study-termination may overestimate this effect.",2022,The combined treatment of metamizole and ibuprofen showed lower mean pain scores over 12 hours than ibuprofen (2.4±1.3 vs 3.8±1.6; P=0.005)).,['35 patients undergoing bilateral lower third molar extraction were randomized'],"['metamizole and ibuprofen', 'Multimodal pain therapy', 'metamizole + placebo', 'ibuprofen + placebo', 'ibuprofen', 'metamizole and ibuprofen vs. either medication alone', 'placebo', 'metamizole + 400mg ibuprofen']","['Consumption of rescue medication', 'mean pain scores', 'Pain ratings, rescue-medication (tramadol), and sleep']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0012586', 'cui_str': 'Dipyrone'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",35.0,0.382465,The combined treatment of metamizole and ibuprofen showed lower mean pain scores over 12 hours than ibuprofen (2.4±1.3 vs 3.8±1.6; P=0.005)).,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schneider', 'Affiliation': 'Clinic of Anesthesiology, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland - tobias.schneider@usb.ch.'}, {'ForeName': 'Eckhard', 'Initials': 'E', 'LastName': 'Mauermann', 'Affiliation': 'Clinic of Anesthesiology, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Ilgenstein', 'Affiliation': 'Ilgenstein Ambulatory Clinic of Oral and Maxillofacial Surgery, Solothurn, Switzerland.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Jaquiery', 'Affiliation': 'Clinic of Oral and Maxillofacial Surgery, Basel, Switzerland.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Ruppen', 'Affiliation': 'Clinic of Anesthesiology, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.'}]",Minerva anestesiologica,['10.23736/S0375-9393.22.16346-7']
756,35420551,The Impact of Local Estrogen on the Urogenital Microbiome in Genitourinary Syndrome of Menopause: A Randomized-Controlled Trial.,"IMPORTANCE


The postmenopausal urinary bladder microbiome is not well defined.
OBJECTIVES


The aims of this study were to characterize the effect of vaginal estrogen on the vaginal and urinary bladder microbiome in postmenopausal women and describe any clinical associations with the symptoms of genitourinary syndrome of menopause.
STUDY DESIGN


This was a participant-masked, randomized controlled trial comparing the effect of a 12-week course of an estrogen-containing vaginal ring to a placebo vaginal ring. Standardized evaluations were performed at baseline and 12 weeks. Vaginal samples were obtained for pH, vaginal maturation index, and microbiome analysis. Concomitant catheterized urine samples were obtained for microbiome analysis. 16S ribosomal RNA gene sequencing was performed to characterize the resident microbial communities, with Lactobacillus relative abundance as the primary outcome variable. Genitourinary syndrome of menopause symptoms was measured using validated questionnaires (Pelvic Floor Distress Inventory-Short Form, Female Sexual Function Index, Vulvovaginal Symptoms Questionnaire).
RESULTS


Of the 39 postmenopausal women randomized, baseline characteristics were similar between arms, with a mean age of 62 years and mean vaginal pH of 5.0. Using intention-to-treat analysis, there were no significant changes in vaginal or urinary Lactobacillus relative abundance. Two participants in each arm removed their ring prior to the end of the study. Eighty percent of participants experienced at least 1 bothersome genitourinary syndrome of menopause symptom. Vulvovaginal dryness and urinary frequency were most common at baseline, whereas painful intercourse and urinary urgency were most common at the final visit, none of which were statistically significant.
CONCLUSIONS


Our study did not show a significant change in the bacterial composition of the vaginal or urinary bladder microbiome after either vaginal ring in this relatively asymptomatic postmenopausal population.",2022,"Vulvovaginal dryness and urinary frequency were most common at baseline, whereas painful intercourse and urinary urgency were most common at the final visit, none of which were statistically significant.
","['postmenopausal women', '39 postmenopausal women randomized', 'Genitourinary Syndrome of Menopause']","['estrogen-containing vaginal ring to a placebo vaginal ring', 'vaginal estrogen', 'Local Estrogen']","['validated questionnaires (Pelvic Floor Distress Inventory-Short Form, Female Sexual Function Index, Vulvovaginal Symptoms Questionnaire', 'Vulvovaginal dryness and urinary frequency', 'bacterial composition of the vaginal or urinary bladder microbiome', 'bothersome genitourinary syndrome of menopause symptom', 'Genitourinary syndrome of menopause symptoms', 'vaginal or urinary Lactobacillus relative abundance', 'painful intercourse and urinary urgency']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}]","[{'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0520589', 'cui_str': 'Vulvovaginal dryness'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}]",39.0,0.307539,"Vulvovaginal dryness and urinary frequency were most common at baseline, whereas painful intercourse and urinary urgency were most common at the final visit, none of which were statistically significant.
","[{'ForeName': 'Jennifer Nicole', 'Initials': 'JN', 'LastName': 'Lillemon', 'Affiliation': 'From the Divisions of Female Pelvic Medicine and Reconstructive Surgery.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Karstens', 'Affiliation': ''}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Nardos', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Garg', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Boniface', 'Affiliation': 'Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'W Thomas', 'Initials': 'WT', 'LastName': 'Gregory', 'Affiliation': 'From the Divisions of Female Pelvic Medicine and Reconstructive Surgery.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000001170']
757,35421679,Ultrasound-assisted spinal anesthesia: A randomized comparison between midline and paramedian approaches.,"STUDY OBJECTIVE


Neuraxial ultrasonography can improve the technical performance of spinal anesthesia. However, there are no data regarding the optimal approach for ultrasound-assisted spinal anesthesia. This study aimed to compare the midline and paramedian approaches for ultrasound-assisted spinal anesthesia in adult orthopedic patients.
DESIGN


A single-center, prospective, randomized controlled trial.
SETTING


Operating room.
PATIENTS


One hundred and twelve patients undergoing orthopedic surgery were included.
INTERVENTIONS


Patients were randomized to undergo either the midline or paramedian approach for preprocedural ultrasound-assisted spinal anesthesia.
MEASUREMENTS


The primary outcome was the number of needle passes required for successful dural puncture. Secondary outcomes were the number of needle insertions, first pass/attempt success rate, procedural time, and the incidence of periprocedural complications.
MAIN RESULTS


The median number of needle passes was significantly lower in the paramedian group (1 [IQR, 1-2]) than in the midline group (3 [2-6]; P < 0.001). The paramedian approach showed higher first pass/attempt success rates compared with the midline group (58.9% vs. 21.4%; 91.1% vs. 53.6%; both, P < 0.001). Total procedure times were significantly shorter in the paramedian group than in the midline group (113 [72.5-146.5] vs. 196 [138-298.5] seconds; P < 0.001). The quality of sonographic images was graded as good in 94.6% of paramedian sagittal oblique views and 54.5% of transverse median views. No significant intergroup differences were found in the incidence of periprocedural complications.
CONCLUSIONS


Compared with the midline approach, the ultrasound-assisted paramedian approach showed improved efficacy in terms of the number of needle manipulations, first pass success rates, and procedural time. These results suggest that the paramedian approach may be more efficient for preprocedural ultrasound-assisted spinal anesthesia.
TRIAL REGISTRATION NUMBER


NCT03491943.",2022,"The paramedian approach showed higher first pass/attempt success rates compared with the midline group (58.9% vs. 21.4%; 91.1% vs. 53.6%; both, P < 0.001).","['adult orthopedic patients', 'spinal anesthesia', 'One hundred and twelve patients undergoing orthopedic surgery were included']","['midline or paramedian approach for preprocedural ultrasound-assisted spinal anesthesia', 'Ultrasound-assisted spinal anesthesia', 'ultrasound-assisted spinal anesthesia']","['number of needle insertions, first pass/attempt success rate, procedural time, and the incidence of periprocedural complications', 'Total procedure times', 'number of needle passes required for successful dural puncture', 'median number of needle passes', 'quality of sonographic images', 'incidence of periprocedural complications', 'number of needle manipulations, first pass success rates, and procedural time', 'higher first pass/attempt success rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0205250', 'cui_str': 'High'}]",112.0,0.055609,"The paramedian approach showed higher first pass/attempt success rates compared with the midline group (58.9% vs. 21.4%; 91.1% vs. 53.6%; both, P < 0.001).","[{'ForeName': 'Sun-Kyung', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeon', 'Initials': 'H', 'LastName': 'Cheun', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Won', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seokha', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: jintae73@gmail.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2022.110823']
758,35421451,Entrainment of somatosensory beta and gamma oscillations accompany improvement in tactile acuity after periodic and aperiodic repetitive sensory stimulation.,"Previous research showed that repetitive sensory stimulation entrains neural oscillations at the stimulation rate, facilitates long-term potentiation like perceptual learning, and improves behavioural performance. For example, short-time repetitive tactile stimulation improved tactile acuity measured with two-point or spatial orientation discrimination tests. The behavioural gain was maximal for a stimulation rate of 20 Hz, the same frequency at which repetitive somatosensory stimulation elicits a steady-state response with maximum amplitude. The current study investigated whether sensory stimulation must be strictly periodic to induce perceptual learning and whether the 20-Hz steady-state response plays a crucial role in the neural mechanisms of perceptual learning. In a crossover-designed experiment, young, healthy adults received sensory stimulation to the fingertip on three subsequent days. The stimulation was either periodic or temporally randomized (aperiodic) with the same number of stimuli. Tactile acuity was assessed with a grating orientation discrimination task, and brain activity was measured with magnetoencephalography (MEG). Stimulus type-by-session interactions were found for behavioural and brain data. Tactile acuity improved more after a session with aperiodic than periodic stimulation. Beta-band 20-Hz steady-state responses were localized in the primary somatosensory cortex contralateral to the stimulated finger and had larger amplitudes after periodic than aperiodic stimulation. Both stimulus types also elicited gamma oscillations, which increased in amplitude more with aperiodic than periodic stimulation. Sensory stimuli caused a phase reset of sensorimotor beta oscillations phase-coupled to alpha oscillations. The system of stimulus-related oscillations was discussed as underlying temporal processing. Learning may result from facilitating the temporal code. More pronounced behavioural gain with aperiodic than periodic stimulation suggests beneficial effects of temporal stimulus variability for perceptual learning.",2022,Beta-band 20-Hz steady-state responses were localized in the primary somatosensory cortex contralateral to the stimulated finger and had larger amplitudes after periodic than aperiodic stimulation.,[],['sensory stimulation'],"['Tactile acuity', 'behavioural performance', 'tactile acuity', 'Beta-band 20-Hz steady-state responses', 'grating orientation discrimination task, and brain activity', 'behavioural gain']",[],"[{'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",,0.0436807,Beta-band 20-Hz steady-state responses were localized in the primary somatosensory cortex contralateral to the stimulated finger and had larger amplitudes after periodic than aperiodic stimulation.,"[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Ross', 'Affiliation': 'Rotman Research Institute, Baycrest Centre for Geriatric Care, Toronto, ON, Canada; Department of Medical Biophysics, University of Toronto, Toronto, ON, Canada. Electronic address: bross@research.baycrest.org.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dobri', 'Affiliation': 'Rotman Research Institute, Baycrest Centre for Geriatric Care, Toronto, ON, Canada; Department of Medical Biophysics, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Jamali', 'Affiliation': 'Rotman Research Institute, Baycrest Centre for Geriatric Care, Toronto, ON, Canada; Music and Health Research Collaboratory, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bartel', 'Affiliation': 'Music and Health Research Collaboratory, University of Toronto, Toronto, ON, Canada.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2022.04.007']
759,35428258,Emotion dysregulation and heart rate variability improve in US veterans undergoing treatment for posttraumatic stress disorder: Secondary exploratory analyses from a randomised controlled trial.,"BACKGROUND


Emotion regulation (ER) is a key process underlying posttraumatic stress disorder (PTSD), yet, little is known about how ER changes with PTSD treatment. Understanding these effects may shed light on treatment processes.
METHODS


We recently completed a non-inferiority design randomised controlled trial demonstrating that a breathing-based yoga practice (Sudarshan kriya yoga; SKY) was not clinically inferior to cognitive processing therapy (CPT) across symptoms of PTSD, depression, or negative affect. Here, in secondary exploratory analyses (intent-to-treat N = 85; per protocol N = 59), we examined whether self-reported ER (Difficulties in Emotion Regulation Scale; DERS) and physiological ER (heart rate variability; HRV) improved with treatment for clinically significant PTSD symptoms among US Veterans.
RESULTS


DERS-Total and all six subscales improved with small-to-moderate effect sizes (d = .24-.66) following CPT or SKY, with no differences between treatment groups. Following SKY (but not CPT), HR max-min (average difference between maximum and minimum beats per minute), LF/HF (low-to-high frequency) ratio, and normalised HF-HRV (high frequency power) improved (moved towards a healthier profile; d = .42-.55).
CONCLUSIONS


To our knowledge, this is the first study to demonstrate that a breathing-based yoga (SKY) improved both voluntary/intentional and automatic/physiological ER. In contrast, trauma-focused therapy (CPT) only reliably improved self-reported ER. Findings have implications for PTSD treatment and interventions for emotional disorders more broadly.
TRIAL REGISTRATION


Secondary analyses of ClinicalTrials.gov NCT02366403 .",2022,"DERS-Total and all six subscales improved with small-to-moderate effect sizes (d = .24-.66) following CPT or SKY, with no differences between treatment groups.",['US veterans undergoing treatment for posttraumatic stress disorder'],"['trauma-focused therapy (CPT', 'Emotion regulation (ER', 'cognitive processing therapy (CPT', 'breathing-based yoga (SKY', 'breathing-based yoga practice (Sudarshan kriya yoga']","['Emotion dysregulation and heart rate variability', 'self-reported ER (Difficulties in Emotion Regulation Scale; DERS) and physiological ER (heart rate variability; HRV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0301560', 'cui_str': 'Ski'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}]",,0.205865,"DERS-Total and all six subscales improved with small-to-moderate effect sizes (d = .24-.66) following CPT or SKY, with no differences between treatment groups.","[{'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Mathersul', 'Affiliation': 'War Related Illness and Injury Study Center (WRIISC), Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, 94304, USA. danielle.mathersul@murdoch.edu.au.'}, {'ForeName': 'Kamini', 'Initials': 'K', 'LastName': 'Dixit', 'Affiliation': 'War Related Illness and Injury Study Center (WRIISC), Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'R Jay', 'Initials': 'RJ', 'LastName': 'Schulz-Heik', 'Affiliation': 'War Related Illness and Injury Study Center (WRIISC), Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Avery', 'Affiliation': 'War Related Illness and Injury Study Center (WRIISC), Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zeitzer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, 94305, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Bayley', 'Affiliation': 'War Related Illness and Injury Study Center (WRIISC), Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, 94304, USA.'}]",BMC psychiatry,['10.1186/s12888-022-03886-3']
760,35429293,"Effect of watermelon supplementation on exercise performance, muscle oxygenation, and vessel diameter in resistance-trained men.","INTRODUCTION


Watermelon shows promise as an ergogenic aid due to its high concentration of L-citrulline, vitamins, minerals, and antioxidants.
PURPOSE


The purpose of this study was to examine the effect of watermelon supplementation on exercise performance, muscle oxygenation, and vessel diameter.
METHODS


In a crossover design fashion, 15 resistance-trained men (22.4 ± 2.9 years; 177.5 ± 7.1 cm; 82.7 ± 11.2 kg) were randomly assigned to supplement with either watermelon juice concentrate (WM; 2.2 g·day -1  L-citrulline) or placebo (PL) for 7 days prior to completing an experimental trial consisting of an isometric mid-thigh pull test and acute bench press protocol. Participants completed two sets of two repetitions at 75% 1 repetition maximum (1-RM) with maximum ballistic intent followed by five repetition-maximum (RM) sets at the same load. Barbell velocity and power were measured via linear position transducer during the first two sets, while volume load and muscle oxygenation were quantified during RM sets. Brachial artery diameter and subjective perception measures were assessed at baseline and immediately pre- and post-exercise.
RESULTS


Except for a greater percent change in skeletal muscle oxygenation during WM compared to PL on average and across sets (mean difference = + 4.1%, p = 0.033, BF 10  = 2.2-54.5), separate traditional and Bayesian analyses of variance with repeated measures, as well as paired-samples t tests for calculated summary measures, revealed no evidence favoring conditional differences in any measure of performance, perception, or muscle oxygenation.
CONCLUSION


Short-term watermelon supplementation does not appear to enhance isometric force production, bench press performance, blood vessel diameter, or muscle oxygenation parameters compared to PL in resistance-trained men.",2022,"Except for a greater percent change in skeletal muscle oxygenation during WM compared to PL on average and across sets (mean difference = + 4.1%, p = 0.033, BF 10  = 2.2-54.5), separate traditional and Bayesian analyses of variance with repeated measures, as well as paired-samples t tests for calculated summary measures, revealed no evidence favoring conditional differences in any measure of performance, perception, or muscle oxygenation.
","['resistance-trained men', '15 resistance-trained men (22.4\u2009±\u20092.9 years; 177.5\u2009±\u20097.1\xa0cm; 82.7\u2009±\u200911.2\xa0kg']","['watermelon supplementation', 'watermelon juice concentrate (WM; 2.2\xa0g·day -1  L-citrulline) or placebo (PL']","['Brachial artery diameter and subjective perception measures', 'exercise performance, muscle oxygenation, and vessel diameter', 'performance, perception, or muscle oxygenation', 'isometric force production, bench press performance, blood vessel diameter, or muscle oxygenation parameters', 'skeletal muscle oxygenation']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517531', 'cui_str': '11.2'}]","[{'cui': 'C0874041', 'cui_str': 'Watermelon Preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",,0.123379,"Except for a greater percent change in skeletal muscle oxygenation during WM compared to PL on average and across sets (mean difference = + 4.1%, p = 0.033, BF 10  = 2.2-54.5), separate traditional and Bayesian analyses of variance with repeated measures, as well as paired-samples t tests for calculated summary measures, revealed no evidence favoring conditional differences in any measure of performance, perception, or muscle oxygenation.
","[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Allied Health and Kinesiology, Hofstra University, Hempstead, NY, 11549, USA. Adam.Gonzalez@hofstra.edu.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Pinzone', 'Affiliation': 'Department of Allied Health and Kinesiology, Hofstra University, Hempstead, NY, 11549, USA.'}, {'ForeName': 'Shaina E', 'Initials': 'SE', 'LastName': 'Lipes', 'Affiliation': 'Department of Allied Health and Kinesiology, Hofstra University, Hempstead, NY, 11549, USA.'}, {'ForeName': 'Gerald T', 'Initials': 'GT', 'LastName': 'Mangine', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA, USA.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Townsend', 'Affiliation': 'Exercise and Nutrition Science Graduate Program, Lipscomb University, Nashville, TN, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Allerton', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Sell', 'Affiliation': 'Department of Allied Health and Kinesiology, Hofstra University, Hempstead, NY, 11549, USA.'}, {'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Ghigiarelli', 'Affiliation': 'Department of Allied Health and Kinesiology, Hofstra University, Hempstead, NY, 11549, USA.'}]",European journal of applied physiology,['10.1007/s00421-022-04940-4']
761,35436944,"Oil-based versus water-based contrast media for hysterosalpingography in infertile women of advanced age, with ovulation disorders or a high risk for tubal pathology: study protocol of a randomized controlled trial (H2Oil2 study).","BACKGROUND


In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography (HSG) increases ongoing pregnancy and subsequent live birth rates when compared to tubal flushing with water-based contrast. It is currently unclear whether an HSG with oil-based contrast also results in more ongoing pregnancies and live births in women of advanced age, women with ovulation disorders, and women with potential tubal pathology when compared to an HSG with water-based contrast.
METHODS


We plan an international, multicentre, open-label, randomized controlled trial (RCT) studying three groups of infertile women who have an indication for tubal patency testing according to their treating physician and additionally; (1) are 39 years of age or older, (2) have an ovulation disorder or (3) have a high risk for tubal pathology based on their medical history. Women with an allergy for iodinated contrast medium are excluded, as are women with diabetes, hyperprolactinemia or untreated hyper- or hypothyroidism, and women with a partner with severe male infertility. After informed consent, women will be randomly allocated to the intervention, tubal flushing with the use of oil-based contrast during HSG or the control group, tubal flushing with the use of water-based contrast during HSG in a 1:1 ratio by the web-based system Castor. The primary endpoint will be ongoing pregnancy leading to live birth with conception within six months after randomization. Secondary outcomes are other pregnancy outcomes, used fertility treatments, adverse events and cost-effectiveness. Based on the expected ongoing pregnancy rate of 17% in the control group and 27% in the intervention group, the sample size will be 930 women (465 per group). Study inclusion is expected to be complete in four years.
DISCUSSION


This multicentre RCT will establish whether, for women of advanced age, women with ovulatory disease, and women who have a high risk for tubal pathology, there is a fertility enhancing effect of tubal flushing with oil-based contrast during HSG and whether the use of this contrast medium is cost-effective. Trial Registration The study was prospectively registered in the Netherlands Trial Register on August 1st 2019 as 'H2Oil2' (reference number NL7925, https://www.trialregister.nl/trial/7925 ).",2022,"After informed consent, women will be randomly allocated to the intervention, tubal flushing with the use of oil-based contrast during HSG or the control group, tubal flushing with the use of water-based contrast during HSG in a 1:1 ratio by the web-based system Castor.","['Women with an allergy for iodinated contrast medium are excluded, as are women with diabetes, hyperprolactinemia or untreated hyper- or hypothyroidism, and women with a partner with severe male infertility', 'infertile women who have an indication for tubal patency testing according to their treating physician and additionally; (1) are 39\xa0years of age or older, (2) have an ovulation disorder or (3) have a high risk for tubal pathology based on their medical history', ""Netherlands Trial Register on August 1st 2019 as 'H2Oil2' (reference number NL7925, https://www.trialregister.nl/trial/7925 "", 'women of advanced age, women with ovulatory disease, and women who have a high risk for tubal pathology', 'women with unexplained infertility, tubal flushing with oil-based contrast during', 'infertile women of advanced age, with ovulation disorders or a high risk for tubal pathology']","['Oil-based versus water-based contrast media for hysterosalpingography', 'tubal flushing with the use of oil-based contrast during HSG or the control group, tubal flushing with the use of water-based contrast during HSG in a 1:1 ratio by the web-based system Castor', 'hysterosalpingography (HSG']","['pregnancy outcomes, used fertility treatments, adverse events and cost-effectiveness', 'pregnancy rate', 'ongoing pregnancy leading to live birth with conception']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C1960405', 'cui_str': 'Iodinated contrast media'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0020514', 'cui_str': 'Hyperprolactinemia'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1411873', 'cui_str': 'Ovulation disorder'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C4285925', 'cui_str': 'Tubal flushing'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C4285925', 'cui_str': 'Tubal flushing'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0004900', 'cui_str': 'Genus Castor'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0009637', 'cui_str': 'Conception'}]",930.0,0.0653855,"After informed consent, women will be randomly allocated to the intervention, tubal flushing with the use of oil-based contrast during HSG or the control group, tubal flushing with the use of water-based contrast during HSG in a 1:1 ratio by the web-based system Castor.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rosielle', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. k.rosielle@amsterdamumc.nl.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kamphuis', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Roest', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mozes', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ziekenhuis Amstelland, Laan van de Helende Meesters 8, 1186 AM, Amstelveen, The Netherlands.'}, {'ForeName': 'E J P', 'Initials': 'EJP', 'LastName': 'van Santbrink', 'Affiliation': 'Department of Reproductive Medicine, Reinier de Graaf Gasthuis, Reinier de Graafweg 5, 2625 AD, Delft, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van de Laar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elkerliek Ziekenhuis, Wesselmanlaan 25, 5707 HA, Helmond, The Netherlands.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Hooker', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zaans Medisch Centrum, Koningin Julianaplein 58, 1502 DV, Zaandam, The Netherlands.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Huppelschoten', 'Affiliation': 'Department of Obstetrics and Gynaecology, Catharina Ziekenhuis, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, 246 Clayton Rd, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Grow Research School for Oncology and Reproduction, Maastricht University, Universiteitssingel 40, 6229 ER, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stoker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Amsterdam Reproduction and Development, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Koks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, De Run 4600, 5504 DB, Veldhoven, Eindhoven, The Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hemingway', 'Affiliation': 'Department of Radiology, Imperial College Healthcare NHS Trust, Hammersmith Hospital, DuCane Road, London, W12 0HS, England.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, 246 Clayton Rd, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}]",BMC women's health,['10.1186/s12905-022-01707-z']
762,35438473,An analysis of the efficacy and safety of compound glycyrrhizin injections in the treatment of drug-induced liver injury using a nationwide database.,"Background Drug-induced liver injury (DILI) refers to liver damage caused by drugs. DILI poses a significant challenge in the development of new drugs. The management of DILI mainly involves the withdrawal of the offending drug, and there is a lack of specific therapy. This study sought to evaluate the efficacy and safety of compound glycyrrhizin (CG) injections in DILI patients. Aim To evaluate the efficacy and safety of compound glycyrrhizin injections in DILI treatment. Methods The clinical data of DILI patients were collected from a nationwide DILI database. Patients were divided into two groups: the compound glycyrrhizin (CG) group who received CG injections, and the control group who received no treatment. The propensity score matching (PSM) method was applied to obtain an even distribution of characteristics between the two groups. The efficacy of the CG injections was assessed by the analysis of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels between the two groups. Results There were 152 patients in the compound glycyrrhizin group and 512 patients in the control group. The PSM method was used to acquire 152 matched pairs. The compound glycyrrhizin group had a significantly higher overall ALT and AST normalization rate than the control group (43.42% vs. 24.34%, p = 0.0004 and 63.82% vs. 38.82%, p ≤ .0001). There was no difference in the levels of renal and serum biochemical parameters between the two groups. Conclusions CG injections are effective in reducing ALT and AST levels in DILI patients, and their safety is comparable to the control group.",2022,There was no difference in the levels of renal and serum biochemical parameters between the two groups.,"['DILI patients', '152 patients in the compound glycyrrhizin group and 512 patients in the control group', 'drug-induced liver injury using a nationwide database']","['compound glycyrrhizin (CG) injections', 'compound glycyrrhizin (CG', 'CG injections, and the control group who received no treatment', 'compound glycyrrhizin injections']","['alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels', 'ALT and AST levels', 'levels of renal and serum biochemical parameters', 'efficacy and safety', 'overall ALT and AST normalization rate']","[{'cui': 'C0860207', 'cui_str': 'Drug-induced disorder of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0061751', 'cui_str': 'Glycyrrhizic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0061751', 'cui_str': 'Glycyrrhizic Acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0128172,There was no difference in the levels of renal and serum biochemical parameters between the two groups.,"[{'ForeName': 'Lvfeng', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Unimed Scientific Inc., Wuxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': ""Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Unimed Scientific Inc., Wuxi, China.'}, {'ForeName': 'Hafiz Khuram', 'Initials': 'HK', 'LastName': 'Raza', 'Affiliation': 'Unimed Scientific Inc., Wuxi, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200001, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200001, China. maoym11968@163.com.'}]",International journal of clinical pharmacy,['10.1007/s11096-022-01402-x']
763,35395926,Video Game Play Does Not Improve Spatial Skills When Controlling for Speed-Accuracy Trade-Off: Evidence From Mental-Rotation and Mental-Folding Tasks.,"Researchers have been divided on the efficacy of computerized cognitive training (CCT) for enhancing spatial abilities, transfer of training, and improving malleability of skills. In this study, we assessed the effects of puzzle video game training on subsequent mental rotation (MR) and mental folding (MF) performance among adults with no cognitive impairment. We assessed participants at baseline with the Shepard-Metzler MR test followed by the differential aptitude test: space relations MF test (i.e., far transfer). We ranked participants' skills on these pre-tests and used a matching technique to form two skill groups from which we then randomly assigned members of each skill group either to an experimental group or a wait-list control group. The experimental group played two puzzle video games closely related to two-dimensional and three-dimensional MR tasks during 4-week training sessions (total of 12 hour of video games). Post-training, participants completed the MR and MF tests again. Two months later, we re-assessed only the experimental group's spatial skills to explore the sustainability of the trained performance. In addition to response times (RT) and error scores (ES), reported separately, we combined these variables into rate correct scores (RCS) to form an integrated measure of potential speed-accuracy trade-offs (SAT). As a result, we did not find significant improvements in MR performance from CCT engagement, nor did participants show a transfer of skills obtained by practicing MR-related puzzle games to a MF task. Based on the current findings, we urge caution when proposing a game-based intervention as a training tool to enhance spatial abilities. We argue that separately interpreting individual test measures can be misleading, as they only partially represent performance. In contrast, composite scores illuminate underlying cognitive strategies and best determine whether an observed improvement is attributable to enhanced capacities or individual heuristics and learned cognitive shortcuts.",2022,"As a result, we did not find significant improvements in MR performance from CCT engagement, nor did participants show a transfer of skills obtained by practicing MR-related puzzle games to a MF task.",['adults with no cognitive impairment'],"['Video Game Play', 'skill group either to an experimental group or a wait-list control group', 'puzzle video game training', 'computerized cognitive training (CCT']","['subsequent mental rotation (MR) and mental folding (MF) performance', 'response times (RT) and error scores (ES', 'Spatial Skills', 'MR performance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0423995', 'cui_str': 'Puzzled'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.00663797,"As a result, we did not find significant improvements in MR performance from CCT engagement, nor did participants show a transfer of skills obtained by practicing MR-related puzzle games to a MF task.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Safaei', 'Affiliation': 'Faculty of Psychology, 125635Payame Noor University, Tehran, Iran.'}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Rahmanian', 'Affiliation': 'Faculty of Psychology, 125635Payame Noor University, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Oraki', 'Affiliation': 'Faculty of Psychology, 125635Payame Noor University, Tehran, Iran.'}, {'ForeName': 'Artyom', 'Initials': 'A', 'LastName': 'Zinchenko', 'Affiliation': 'Department of Psychology, Ludwig-Maximilians-Universität München, Munich, Germany.'}]",Perceptual and motor skills,['10.1177/00315125221078982']
764,35399553,Decreasing the RAG:SAG ratio of granola cereal predictably reduces postprandial glucose and insulin responses: a report of four randomised trials in healthy adults.,"Dietary starch contains rapidly (RAG) and slowly available glucose (SAG). To establish the relationships between the RAG:SAG ratio and postprandial glucose, insulin and hunger, we measured postprandial responses elicited by test meals varying in the RAG:SAG ratio in  n  160 healthy adults, each of whom participated in one of four randomised cross-over studies ( n  40 each): a pilot trial comparing six chews (RAG:SAG ratio 2·4-42·7) and three studies comparing a test granola (TG1-3, RAG:SAG ratio 4·5-5·2) with a control granola (CG1-3, RAG:SAG ratio 54·8-69·3). Within studies, test meals were matched for fat, protein and available carbohydrate. Blood glucose, serum insulin and subjective hunger were measured for 3 h. Data were subjected to repeated-measures analysis of variance (ANOVA). The relationships between the RAG:SAG ratio and postprandial end points were determined by regression analysis. In the pilot trial, 0-2 h glucose incremental areas under the curve (iAUC0-2; primary end point) varied across the six chews ( P  = 0·014) with each 50 % reduction in the RAG:SAG ratio reducing relative glucose response by 4·0 %. TGs1-3 elicited significantly lower glucose iAUC0-2 than CGs1-3 by 17, 18 and 17 %, respectively (similar to the 15 % reduction predicted by the pilot trial). The combined means ± sem ( n  120) for TC and CG were glucose iAUC0-2, 98 ± 4  v . 118 ± 4 mmol × min/l ( P  < 0·001), and insulin iAUC0-2, 153 ± 9  v . 184 ± 11 nmol × h/l ( P  < 0·001), respectively. Neither postprandial hunger nor glucose or hunger increments 2 h after eating differed significantly between TG and CG. We concluded that TGs with RAG:SAG ratios <5·5 predictably reduced glycaemic and insulinaemic responses compared with CGs with RAG:SAG ratios >54. However, compared with CG, TG did not reduce postprandial hunger or delay the return of glucose or hunger to baseline.",2022,"However, compared with CG, TG did not reduce postprandial hunger or delay the return of glucose or hunger to baseline.","['n  160 healthy adults', 'healthy adults']","['test granola (TG1-3, RAG:SAG ratio 4·5-5·2) with a control granola (CG1-3, RAG:SAG ratio 54·8-69·3', 'CG, TG', 'RAG']","['glucose iAUC0', 'postprandial hunger nor glucose or hunger increments 2 h after eating', 'glycaemic and insulinaemic responses', 'postprandial glucose and insulin responses', 'Blood glucose, serum insulin and subjective hunger', 'postprandial hunger or delay the return of glucose or hunger', 'Dietary starch contains rapidly (RAG) and slowly available glucose (SAG']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1865803', 'cui_str': 'Peroxisome Biogenesis Disorder, Complementation Group 1'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",160.0,0.102767,"However, compared with CG, TG did not reduce postprandial hunger or delay the return of glucose or hunger to baseline.","[{'ForeName': 'Thomas M S', 'Initials': 'TMS', 'LastName': 'Wolever', 'Affiliation': 'INQUIS Clinical Research, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Jenkins', 'Affiliation': 'INQUIS Clinical Research, Toronto, Ontario, Canada.'}, {'ForeName': 'Janice E', 'Initials': 'JE', 'LastName': 'Campbell', 'Affiliation': 'INQUIS Clinical Research, Toronto, Ontario, Canada.'}, {'ForeName': 'Adish', 'Initials': 'A', 'LastName': 'Ezatagha', 'Affiliation': 'INQUIS Clinical Research, Toronto, Ontario, Canada.'}, {'ForeName': 'Simarata', 'Initials': 'S', 'LastName': 'Dhillon', 'Affiliation': 'PepsiCo, Inc., R&D Health & Nutrition Sciences, Barrington, IL, USA.'}, {'ForeName': 'Jodee', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'PepsiCo, Inc., R&D Health & Nutrition Sciences, Barrington, IL, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schuette', 'Affiliation': 'PepsiCo, Inc., R&D Health & Nutrition Sciences, Barrington, IL, USA.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'PepsiCo, Inc., R&D Measurement Sciences, Barrington, IL, USA.'}, {'ForeName': 'YiFang', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'PepsiCo, Inc., R&D Health & Nutrition Sciences, Barrington, IL, USA.'}]",Journal of nutritional science,['10.1017/jns.2022.22']
765,35400227,Burpee Interval Training Is Associated With a More Favorable Affective Valence and Psychological Response Than Traditional High Intensity Exercise.,"Acute psychological responses to physical activity may help explain long-term adherence to it. Thus, we compared acute psychological responses to different exercise protocols with identical durations. Eighteen moderately active young adults [ M age  = 23,  SD  = 3 years;  M VO 2max  (maximum oxygen consumption) = 42.8,  SD  = 4.3 mL·kg -1 ·min -1 ;  M BMI  (body mass index) = 24,  SD  = 2 kg·m -2 ] completed three low-volume exercise sessions in a crossover research design: (a) sprint interval training (SIT), (b) burpee interval training (BIT) requiring 10 × 5 second efforts with 35 seconds of passive recovery, and (c) a single bout of vigorous intensity continuous training (VICT) requiring 6 minutes and 5 seconds of running at ∼85% of peak heart rate (HR peak ). We assessed participants' ratings of perceived exertion (RPE), affective valence, enjoyment, intention, preference, and self-reported recovery and wellness before, during, and after each session. BIT was associated with significantly greater enjoyment, preference, and exercise intention (at 5 × week) than VICT ( p  ≤ .05). SIT elicited greater RPE ( M  = 5.38,  SD  = 2.00) than both BIT ( M  = 2.88,  SD  = 1.23) and VICT ( M  = 3.55,  SD  = 1.38) ( p  ≤ .05), and we observed a higher increase in RPE over time with SIT versus BIT ( p  = .019). For affective valence, SIT ( M =  0.55,  SD  = 2.12) elicited a more aversive response than both BIT ( M =  2.55,  SD  = 1.09) and VICT ( M =  1.94,  SD =  1.51) ( p  ≤ .05), and there was a higher increase in this aversive response to SIT over time ( p  < .05). Forty-eight-hour postexercise session muscle soreness was significantly lower with VICT than with BIT ( p  = .03). Overall, BIT was associated with more positive psychological responses than SIT and VICT.",2022,"BIT was associated with significantly greater enjoyment, preference, and exercise intention (at 5 × week) than VICT ( p  ≤ .05).","['Eighteen moderately active young adults [ M age  = 23,  SD  ']","['VICT', 'low-volume exercise sessions', 'sprint interval training (SIT), (b) burpee interval training (BIT) requiring 10 × 5 second efforts with 35 seconds of passive recovery, and (c) a single bout of vigorous intensity continuous training (VICT) requiring 6\xa0minutes and 5\xa0seconds of running at ∼85% of peak heart rate (HR peak ']","['aversive response to SIT', 'SIT elicited greater RPE', 'postexercise session muscle soreness', 'aversive response', 'positive psychological responses', ""participants' ratings of perceived exertion (RPE), affective valence, enjoyment, intention, preference, and self-reported recovery and wellness"", 'RPE', 'enjoyment, preference, and exercise intention']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0249666,"BIT was associated with significantly greater enjoyment, preference, and exercise intention (at 5 × week) than VICT ( p  ≤ .05).","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Mayr Ojeda', 'Affiliation': 'Department of Physical Education and Health, Higher Institute of Physical Education, 56724University of the Republic, Montevideo, Uruguay.'}, {'ForeName': 'Flávio Antônio de Souza', 'Initials': 'FAS', 'LastName': 'Castro', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Aquatic Sports Research Group, 28124Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Reich', 'Affiliation': 'School of Health Sciences, Universidad Católica del Uruguay, Montevideo, Uruguay.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Astorino', 'Affiliation': 'Department of Kinesiology, 14673California State University San Marcos, San Marcos, CA, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Benítez-Flores', 'Affiliation': 'Department of Physical Education and Health, Higher Institute of Physical Education, 56724University of the Republic, Montevideo, Uruguay.'}]",Perceptual and motor skills,['10.1177/00315125221083180']
766,35404075,Delamanid Added to an Optimized Background Regimen in Children with Multidrug-Resistant Tuberculosis: Results of a Phase I/II Clinical Trial.,"Delamanid has been demonstrated to be safe and effective for treatment of adult multidrug-resistant tuberculosis (MDR-TB) and has been approved by the European Commission for treatment of pediatric MDR-TB patients at least 10 kg in weight, making the drug no longer limited to adults. A 10-day phase I age deescalation study was conducted, followed by a 6-month phase II extension study, to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of delamanid when combined with optimized background regimen (OBR) in children (birth to 17 years) with MDR-TB. Delamanid administered at 100 mg twice-daily (BID), 50 mg BID, and 25 mg BID resulted in exposures in 12- to 17- ( n  = 7), 6- to 11- ( n  = 6), and 3- to 5-year-olds ( n  = 12), respectively, comparable with those in adults at the approved adult dosage (100 mg BID). Exposures in 0- to 2-year-olds ( n  = 12) following a weight-based dosing regimen (5 mg once daily [QD] to 10 mg BID) were lower than predicted from pharmacokinetic modeling of the older three age groups and below target exposures in adults. Overall, the safety profile of delamanid in children 0 to 17 years of age was similar to the adult profile. At 24 months after the first delamanid dose, 33/37 children (89.2%) had favorable treatment outcomes, as defined by the World Health Organization (15/37 [40.5%] cured and 18/37 [48.6%] completed treatment). A new pediatric delamanid formulation used in 0- to 2-year-olds and 3- to 5-year-olds was palatable per child/parent and nurse/investigator reports. Data from initial phase I/II studies inform our understanding of delamanid use in children and support its further assessment in the setting of pediatric MDR-TB. (This study has been registered at ClinicalTrials.gov under identifiers NCT01856634 [phase I trial] and NCT01859923 [phase II trial].).",2022,"Overall, the safety profile of delamanid in children 0 to 17 years of age was similar to the adult profile.","['Children with Multidrug-Resistant Tuberculosis', '11', 'children', 'children 0 to 17\u2009years of age was similar to the adult profile']","['weight-based dosing regimen (5\u2009mg once daily [QD', 'Delamanid Added to an Optimized  Regimen', 'optimized background regimen (OBR']","['World Health Organization', 'pharmacokinetics, safety, tolerability', 'safety profile of delamanid']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206526', 'cui_str': 'Multidrug resistant tuberculosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3489682', 'cui_str': 'delamanid'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3489682', 'cui_str': 'delamanid'}]",,0.171813,"Overall, the safety profile of delamanid in children 0 to 17 years of age was similar to the adult profile.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Garcia-Prats', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch Universitygrid.11956.3a, Cape Town, South Africa.'}, {'ForeName': 'Melchior', 'Initials': 'M', 'LastName': 'Frias', 'Affiliation': 'De La Salle Health Science Center, Cavite, Philippines.'}, {'ForeName': 'Louvina', 'Initials': 'L', 'LastName': 'van der Laan', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch Universitygrid.11956.3a, Cape Town, South Africa.'}, {'ForeName': 'Anjanette', 'Initials': 'A', 'LastName': 'De Leon', 'Affiliation': 'Lung Center of the Philippines, Quezon City, Philippines.'}, {'ForeName': 'Maria Tarcela', 'Initials': 'MT', 'LastName': 'Gler', 'Affiliation': 'De La Salle Health Science Center, Cavite, Philippines.'}, {'ForeName': 'H Simon', 'Initials': 'HS', 'LastName': 'Schaaf', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch Universitygrid.11956.3a, Cape Town, South Africa.'}, {'ForeName': 'Anneke C', 'Initials': 'AC', 'LastName': 'Hesseling', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch Universitygrid.11956.3a, Cape Town, South Africa.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Malikaarjun', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hafkin', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/aac.02144-21']
767,35404074,"Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Expression Inhibitor GST-HG131 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial.","GST-HG131, a novel dihydroquinolizinone (DHQ) compound, has been shown to reduce circulating levels of HBsAg in animals. This first-in-human trial evaluated the safety, tolerability, and pharmacokinetic profile of GST-HG131 in healthy Chinese subjects. This was a double-blind, randomized, placebo-controlled phase Ia clinical trial that was conducted in two parts. Part A was a single-ascending-dose (SAD; GST-HG131 10 30, 60, 100, 150, 200, 250 or 300 mg or placebo) study, which also assessed the food effect of GST-HG131 100 mg. Part B was a multiple-ascending-dose (MAD; GST-HG131 30, 60 or 100 mg or placebo BID) study. Tolerability assessments included adverse events, vital signs, 12-lead electrocardiogram, physical examination, and clinical laboratory tests. PK analyses were conducted in blood, urine, and fecal samples. Single doses of GST-HG131 ≤ 300 mg and multiple doses of GST-HG131 ≤ 60 mg were generally safe and well tolerated; however, multiple dosing was stopped at GST-HG131 100 mg, as pre-defined stopping rules specified in the protocol were met (Grade II drug related AEs of nausea and dizziness in >50% of subjects). In the SAD study, median t max  of GST-HG131 was 1-6 h, and t 1/2  ranged from 3.88 h to 14.3 h. PK parameters were proportional to dose. Exposure was reduced after food intake. In the MAD study, steady-state was attained on day 4, and there was no apparent plasma accumulation of GST-HG131 on day 7 (R acc  < 1.5). In conclusion, GST-HG131 exhibited an acceptable safety profile in healthy subjects at single doses ranging from 10-300 mg and multiple doses (BID) ranging from 30-60 mg, and the MAD doses (30 mg and 60 mg BID) that potentially meet the therapeutic AUC requirements. These findings imply GST-HG131 has potential as a therapeutic option for CHB infection. (This study has been registered at ClinicalTrials.gov under identifier NCT04499443.).",2022,"In the MAD study, steady-state was attained on day 4, and there was no apparent plasma accumulation of GST-HG131 on day 7 (R acc  < 1.5).","['Healthy Chinese Subjects', 'healthy Chinese subjects', 'healthy subjects']","['placebo', 'GST-HG131', 'Novel Hepatitis B Virus Expression Inhibitor GST-HG131']","['safe and well tolerated', 'steady-state', 'Tolerability assessments included adverse events, vital signs, 12-lead electrocardiogram, physical examination, and clinical laboratory tests', 'Safety, Tolerability, and Pharmacokinetics', 'safety, tolerability, and pharmacokinetic profile', 'nausea and dizziness', 'median t max  of GST-HG131']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017837', 'cui_str': 'Glutathione transferase'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017837', 'cui_str': 'Glutathione transferase'}]",,0.146911,"In the MAD study, steady-state was attained on day 4, and there was no apparent plasma accumulation of GST-HG131 on day 7 (R acc  < 1.5).","[{'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Yusi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Hanxin', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Clinical Laboratory, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Lou', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Fujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.'}, {'ForeName': 'Wenqiang', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Fujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Fujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Fujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.'}, {'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Fujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'WuXi AppTec, Wuhan, China.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'WuXi AppTec, Shanghai, China.'}, {'ForeName': 'Shuhui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'WuXi AppTec, Shanghai, China.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Department of Hepatology, First Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.'}]",Antimicrobial agents and chemotherapy,['10.1128/aac.00094-22']
768,35416909,Association of Low-Dose Triple Combination Therapy vs Usual Care With Time at Target Blood Pressure: A Secondary Analysis of the TRIUMPH Randomized Clinical Trial.,"Importance


Cumulative exposure to high blood pressure (BP) is an adverse prognostic marker. Assessments of BP control over time, such as time at target, have been developed but assessments of the effects of BP-lowering interventions on such measures are lacking.
Objective


To evaluate whether low-dose triple combination antihypertensive therapy was associated with greater rates of time at target compared with usual care.
Design, Setting, and Participants


The Triple Pill vs Usual Care Management for Patients With Mild-to-Moderate Hypertension (TRIUMPH) trial was a open-label randomized clinical trial of low-dose triple BP therapy vs usual care conducted in urban hospital clinics in Sri Lanka from February 2016 to May 2017. Adults with hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg or in patients with diabetes or chronic kidney disease, systolic BP >130 mm Hg and/or diastolic BP >80 mm Hg) requiring initiation (untreated patients) or escalation (patients receiving monotherapy) of antihypertensive therapy were included. Patients were excluded if they were currently taking 2 or more blood pressure-lowering drugs or had severe or uncontrolled blood pressure, accelerated hypertension or physician-determined need for slower titration of treatment, a contraindication to the triple combination pill therapy, an unstable medical condition, or clinically significant laboratory values deemed by researchers to be unsuitable for the study. All 700 individuals in the original trial were included in the secondary analysis. This post hoc analysis was conducted from December 2020 to December 2021.
Intervention


Once-daily fixed-dose triple combination pill (telmisartan 20 mg, amlodipine 2.5 mg, and chlorthalidone 12.5 mg) therapy vs usual care.
Main Outcomes and Measures


Between-group differences in time at target were compared over 24 weeks of follow-up, with time at target defined as percentage of time at target BP.
Results


There were a total of 700 randomized patients (mean [SD] age, 56 [11] years; 403 [57.6%] women). Patients allocated to the triple pill group (n = 349) had higher time at target compared with those in the usual care group (n = 351) over 24 weeks' follow-up (64% vs 43%; risk difference, 21%; 95% CI, 16-26; P < .001). Almost twice as many patients receiving triple pill therapy achieved more than 50% time at target during follow-up (64% vs 37%; P < .001). The association of the triple pill with an increase in time at target was seen early, with most patients achieving more than 50% time at target by 12 weeks. Those receiving the triple pill achieved a consistently higher time at target at all follow-up periods compared with those receiving usual care (mean [SD]: 0-6 weeks, 36.3% [30.9%] vs 21.7% [28.9%]; P < .001; 6-12 weeks, 55.2% [31.9%] vs 33.7% [33.0%]; P < .001; 12-24 weeks, 66.0% [31.1%] vs 43.5% [34.3%]; P < .001).
Conclusions and Relevance


To our knowledge, this analysis provides the first estimate of time at target as an outcome assessing longitudinal BP control in a randomized clinical trial. Among patients with mild to moderate hypertension, treatment with a low-dose triple combination pill was associated with substantially higher time at target compared with usual care.",2022,"Those receiving the triple pill achieved a consistently higher time at target at all follow-up periods compared with those receiving usual care (mean [SD]: 0-6 weeks, 36.3% [30.9%] vs 21.7% [28.9%]; P < .001; 6-12 weeks, 5.2% [31.9%] vs 33.7% [33.0%]; P < .001; 12-24 weeks, 66.0% [31.1%] vs 43.5% [34.3%]; P < .001).
","['patients with mild to moderate hypertension', '700 randomized patients (mean [SD] age, 56 [11] years; 403 [57.6%] women', 'Patients were excluded if they were currently taking 2 or more blood pressure-lowering drugs or had severe or uncontrolled blood pressure, accelerated hypertension or physician-determined need for slower titration of treatment, a contraindication to the triple combination pill therapy, an unstable medical condition, or clinically significant laboratory values deemed by researchers to be unsuitable for the study', 'urban hospital clinics in Sri Lanka from February 2016 to May 2017', 'December 2020 to December 2021', 'Patients', '130 mm Hg and/or diastolic BP >80 mm Hg) requiring initiation (untreated patients) or escalation (patients receiving monotherapy) of antihypertensive therapy were included', 'Adults with hypertension (systolic BP >140 mm Hg', 'All 700 individuals in the original trial were included in the secondary analysis', 'patients with diabetes or chronic kidney disease, systolic BP']","['blood pressure (BP', 'low-dose triple BP therapy', 'Triple Pill vs Usual Care Management', 'Low-Dose Triple Combination Therapy vs Usual Care', 'Intervention\n\n\nOnce-daily fixed-dose triple combination pill (telmisartan 20 mg, amlodipine 2.5 mg, and chlorthalidone 12.5 mg) therapy vs usual care']","['Blood Pressure', 'rates of time', 'percentage of time at target BP', 'and/or diastolic BP ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1127537', 'cui_str': 'telmisartan 20 MG'}, {'cui': 'C1124795', 'cui_str': 'Amlodipine 2.5 MG'}, {'cui': 'C1126966', 'cui_str': 'Chlorthalidone 12.5 MG'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",700.0,0.0739501,"Those receiving the triple pill achieved a consistently higher time at target at all follow-up periods compared with those receiving usual care (mean [SD]: 0-6 weeks, 36.3% [30.9%] vs 21.7% [28.9%]; P < .001; 6-12 weeks, 5.2% [31.9%] vs 33.7% [33.0%]; P < .001; 12-24 weeks, 66.0% [31.1%] vs 43.5% [34.3%]; P < .001).
","[{'ForeName': 'Sonali R', 'Initials': 'SR', 'LastName': 'Gnanenthiran', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Di Tanna', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Salam', 'Affiliation': 'The George Institute for Global Health, Hyderabad, India University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'H Asita', 'Initials': 'HA', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Guggilla', 'Affiliation': 'Department of Population Medicine and Lifetsyle Diseases Prevention, Faculty of Medicine with the Division of Dentistry and Division of Medical Education in English, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'The George Institute for Global Health, Hyderabad, India University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nitish', 'Initials': 'N', 'LastName': 'Naik', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Selak', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control and Public Health Foundation, New Delhi, India.'}, {'ForeName': 'Aletta E', 'Initials': 'AE', 'LastName': 'Schutte', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2022.0471']
769,35421875,A Houttuynia cordata-based Chinese herbal formula improved symptoms of allergic rhinitis during the COVID-19 pandemic.,"BACKGROUND


The symptoms of coronavirus disease 2019 (COVID-19) such as hyposmia, rhinorrhea, nasal obstruction, and cough are similar to those of chronic allergic rhinitis (AR). Such symptoms can easily lead AR patients to unnecessary anxiety, misdiagnosis, and invasive diagnostic tests in the COVID-19 pandemic. Interleukin-6 (IL-6) is an important mediator for chronic AR and plays a crucial role in the inflammation of COVID-19. Houttuynia cordata (HC) has been shown to reduce nasal congestion and swelling by suppressing the activation of IL-6 and is used to fight COVID-19. A novel HC-based Chinese herbal formula, Zheng-Yi-Fang (ZYF), was developed to test effects on nasal symptoms of patients with AR in the COVID-19 pandemic.
METHODS


Participants aged between 20 and 60 years with at least a 2-year history of moderate to severe perennial AR were enrolled. Eligible participants were randomly allocated to either the intervention group (taking ZYF) or the control group (using regular western medicine) for 4 weeks. The Chinese version of the Rhinosinusitis Outcome Measures was used to evaluate impacts on quality of life and nasal symptoms of participants with AR. In addition, the effect of ZYF on lipopolysaccharide (LPS)-induced IL-6 was investigated.
RESULTS


Participants with AR taking ZYF improved their symptoms of nasal obstruction, nasal secretion, hyposmia, and postnasal drip in comparison with those of the control group. Meanwhile, ZYF exhibited inhibition of IL-6 secretion in the LPS-induced inflammatory model.
CONCLUSION


ZYF has potential effects to relieve nasal symptoms for AR during the COVID-19 pandemic.",2022,The Chinese version of the Rhinosinusitis Outcome Measures was used to evaluate impacts on quality of life and nasal symptoms of participants with AR.,"['Participants aged between 20 to 60 years with at least a 2-year history of moderate to severe perennial AR were enrolled', 'Eligible participants', 'patients with AR in the COVID-19 pandemic']","['ZYF', 'novel HC-based Chinese herbal formula, Zheng-Yi-Fang (ZYF', 'Houttuynia cordata (HC', 'control group (using regular western medicine', 'intervention group (taking ZYF', 'Houttuynia Cordata-based Chinese herbal formula']","['IL-6 secretion', 'Interleukin-6 (IL-6', 'symptoms of nasal obstruction, nasal secretion, hyposmia, and postnasal drip', 'symptoms of allergic rhinitis', 'quality of life and nasal symptoms of participants with AR']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0574439', 'cui_str': 'Fang language'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1001040', 'cui_str': 'Dokudami'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",,0.0488092,The Chinese version of the Rhinosinusitis Outcome Measures was used to evaluate impacts on quality of life and nasal symptoms of participants with AR.,"[{'ForeName': 'Kai-Wei', 'Initials': 'KW', 'LastName': 'Chang', 'Affiliation': 'Institute of Traditional Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Tung-Yi', 'Initials': 'TY', 'LastName': 'Lin', 'Affiliation': 'Institute of Traditional Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shu-Ling', 'Initials': 'SL', 'LastName': 'Fu', 'Affiliation': 'Institute of Traditional Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Yueh-Hsin', 'Initials': 'YH', 'LastName': 'Ping', 'Affiliation': 'Department of Pharmacology, School of Medicine and Institute of Pharmacology, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Fang-Pey', 'Initials': 'FP', 'LastName': 'Chen', 'Affiliation': 'Institute of Traditional Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Yen-Ying', 'Initials': 'YY', 'LastName': 'Kung', 'Affiliation': 'Institute of Traditional Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000732']
770,35421848,The Effect of a Web-Based Cervical Cancer Survivor's Story on Parents' Behavior and Willingness to Consider Human Papillomavirus Vaccination for Daughters: Randomized Controlled Trial.,"BACKGROUND


Providing adequate information to parents who have children eligible for human papillomavirus (HPV) vaccination is essential to overcoming vaccine hesitancy in Japan, where the government recommendation has been suspended. However, prior trials assessing the effect of brief educational tools have shown only limited effects on increasing the willingness of parents to vaccinate their daughters.
OBJECTIVE


The aim of this trial is to assess the effect of a cervical cancer survivor's story on the willingness of parents to get HPV vaccination for their daughters.
METHODS


In this double-blinded, randomized controlled trial (RCT) implemented online, we enrolled 2175 participants aged 30-59 years in March 2020 via a webpage and provided them with a questionnaire related to the following aspects: awareness regarding HPV infection and HPV vaccination, and willingness for HPV vaccination. Participants were randomly assigned (1:1) to see a short film on a cervical cancer survivor or nothing, stratified by sex (male vs female) and willingness for HPV vaccination prior to randomization (yes vs no). The primary endpoint was the rate of parents who agreed for HPV vaccination for their daughters. The secondary endpoint was the rate of parents who agreed for HPV vaccination for their daughters and the HPV vaccination rate at 3 months. The risk ratio (RR) was used to assess the interventional effect.
RESULTS


Of 2175 participants, 1266 (58.2%) were men and 909 (41.8%) were women. A total of 191 (8.8%) participants were willing to consider HPV vaccination prior to randomization. Only 339 (15.6%) participants were aware of the benefits of HPV vaccination. In contrast, 562 (25.8%) participants were aware of the adverse events of HPV vaccination. Although only 476 (21.9%) of the respondents displayed a willingness to vaccinate their daughters for HPV, there were 7.5% more respondents in the intervention group with this willingness immediately after watching the short film (RR 1.41, 95% CI 1.20-1.66). In a subanalysis, the willingness in males to vaccinate daughters was significantly higher in the intervention group (RR 1.50, 95% CI 1.25-1.81); however, such a difference was not observed among females (RR 1.21, 95% CI 0.88-1.66). In the follow-up survey at 3 months, 1807 (83.1%) participants responded. Of these, 149 (8.2%) responded that they had had their daughters receive vaccination during the 3 months, even though we could not see the effect of the intervention: 77 (7.9%) in the intervention group and 72 (8.7%) in the control group.
CONCLUSIONS


A cervical cancer survivor's story increases immediate willingness to consider HPV vaccination, but the effect does not last for 3 months. Furthermore, this narrative approach to parents does not increase vaccination rates in children eligible for HPV vaccination.
TRIAL REGISTRATION


UMIN Clinical Trials Registry UMIN000039273; https://tinyurl.com/bdzjp4yf.",2022,"In a sub-analysis, the willingness to vaccinate daughters in males was significantly higher in the intervention group (RR 1.50, 95% CI 1.25-1.81); however, such a difference was not observed among females (RR 1.21, 95% CI 0.88-1.66).","['2175 participants aged 30-59 years in March 2020 via a webpage and provided them with a questionnaire related to the following aspects: awareness regarding HPV infection and HPV vaccination, and willingness for HPV vaccination', 'A total of 191 (8.8%) participants were willing to consider HPV vaccination prior to randomization', 'Japanese parents with at least one daughter aged 11 to 18 years old', '2175 participants, 1266 (58.2%) were men and 909 (41.8%) were women', 'parents who have children eligible for human papillomavirus (HPV) vaccination', 'children eligible for HPV vaccination']","['web-based cervical cancer survivor story', 'cervical cancer survivor story', 'short film of cervical cancer survivor story or nothing, stratified by sex (male vs. female) and willingness to HPV vaccination']","['adverse events of HPV vaccination', 'rate of parents who agreed to HPV vaccination for their daughters and the HPV vaccination rate', 'vaccination rates', 'Risk ratio', 'rate of parents who agreed to HPV vaccination']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",2175.0,0.399127,"In a sub-analysis, the willingness to vaccinate daughters in males was significantly higher in the intervention group (RR 1.50, 95% CI 1.25-1.81); however, such a difference was not observed among females (RR 1.21, 95% CI 0.88-1.66).","[{'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Obstetrics and Gynecology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Sukegawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Ueda', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Sekine', 'Affiliation': 'Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Enomoto', 'Affiliation': 'Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Melamed', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Wright', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Etsuko', 'Initials': 'E', 'LastName': 'Miyagi', 'Affiliation': 'Department of Obstetrics and Gynecology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}]",JMIR public health and surveillance,['10.2196/34715']
771,35429480,"Safety and efficacy of ganaxolone in patients with CDKL5 deficiency disorder: results from the double-blind phase of a randomised, placebo-controlled, phase 3 trial.","BACKGROUND


CDKL5 deficiency disorder (CDD) is a rare, X-linked, developmental and epileptic encephalopathy characterised by severe global developmental impairment and seizures that can begin in the first few months after birth and are often treatment refractory. Ganaxolone, an investigational neuroactive steroid, reduced seizure frequency in an open-label, phase 2 trial that included patients with CDD. We aimed to further assess the efficacy and safety of ganaxolone in patients with CDD-associated refractory epilepsy.
METHODS


In the double-blind phase of this randomised, placebo-controlled, phase 3 trial, done at 39 outpatient clinics in eight countries (Australia, France, Israel, Italy, Poland, Russia, the UK, and the USA), patients were eligible if they were aged 2-21 years with a pathogenic or probably pathogenic CDKL5 variant and at least 16 major motor seizures (defined as bilateral tonic, generalised tonic-clonic, bilateral clonic, atonic, or focal to bilateral tonic-clonic) per 28 days in each 4-week period of an 8-week historical period. After a 6-week prospective baseline period, patients were randomly assigned (1:1) via an interactive web response system to receive either enteral adjunctive ganaxolone or matching enteral adjunctive placebo (maximum dose 63 mg/kg per day for patients weighing ≤28 kg or 1800 mg/day for patients weighing >28 kg) for 17 weeks. Patients, caregivers, investigators (including those analysing data), trial staff, and the sponsor (other than the investigational product manager) were masked to treatment allocation. The primary efficacy endpoint was percentage change in median 28-day major motor seizure frequency from the baseline period to the 17-week double-blind phase and was analysed (using a Wilcoxon-rank sum test) in all patients who received at least one dose of trial treatment and for whom baseline data were available. Safety (compared descriptively across groups) was analysed in all patients who received at least one dose of trial treatment. This study is registered with ClinicalTrials.gov, NCT03572933, and the open-label extension phase is ongoing.
FINDINGS


Between June 25, 2018, and July 2, 2020, 114 patients were screened for eligibility, of whom 101 (median age 6 years [IQR 3 to 10]) were randomly assigned to receive either ganaxolone (n=50) or placebo (n=51). All patients received at least one dose of a study drug, but seizure frequency for one patient in the ganaxolone group was not recorded at baseline and so the primary endpoint was analysed in a population of 100 patients. There was a median percentage change in 28-day major motor seizure frequency of -30·7% (IQR -49·5 to -1·9) in the ganaxolone group and of -6·9% (-24·1 to 39·7) in the placebo group (p=0·0036). The Hodges-Lehmann estimate of median difference in responses to ganaxolone versus placebo was -27·1% (95% CI -47·9 to - 9·6). Treatment-emergent adverse events occurred in 43 (86%) of 50 patients in the ganaxolone group and in 45 (88%) of 51 patients in the placebo group. Somnolence, pyrexia, and upper respiratory tract infections occurred in at least 10% of patients in the ganaxolone group and more frequently than in the placebo group. Serious adverse events occurred in six (12%) patients in the ganaxolone group and in five (10%) patients in the placebo group. Two (4%) patients in the ganaxolone group and four (8%) patients in the placebo group discontinued the trial. There were no deaths in the double-blind phase.
INTERPRETATION


Ganaxolone significantly reduced the frequency of CDD-associated seizures compared with placebo and was generally well tolerated. Results from what is, to our knowledge, the first controlled trial in CDD suggest a potential treatment benefit for ganaxolone. Long-term treatment is being assessed in the ongoing open-label extension phase of this trial.
FUNDING


Marinus Pharmaceuticals.",2022,Treatment-emergent adverse events occurred in 43 (86%) of 50 patients in the ganaxolone group and in 45 (88%) of 51 patients in the placebo group.,"['patients with CDD-associated refractory epilepsy', 'Between June 25, 2018, and July 2, 2020, 114 patients were screened for eligibility, of whom 101 (median age 6 years [IQR 3 to 10', '39 outpatient clinics in eight countries (Australia, France, Israel, Italy, Poland, Russia, the UK, and the USA), patients were eligible if they were aged 2-21 years with a pathogenic or probably pathogenic CDKL5 variant and at least 16 major motor seizures (defined as bilateral tonic, generalised tonic-clonic, bilateral clonic, atonic, or focal to bilateral tonic-clonic) per 28 days in each 4-week period of an 8-week historical period', 'patients with CDD', 'patients with CDKL5 deficiency disorder']","['ganaxolone', 'Ganaxolone', 'enteral adjunctive ganaxolone or matching enteral adjunctive placebo', 'ganaxolone versus placebo', 'placebo']","['28-day major motor seizure frequency', 'frequency of CDD-associated seizures', 'Safety and efficacy', 'seizure frequency', 'Treatment-emergent adverse events', 'Serious adverse events', 'Somnolence, pyrexia, and upper respiratory tract infections', 'percentage change in median 28-day major motor seizure frequency', 'efficacy and safety', 'tolerated', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4750718', 'cui_str': 'Cyclin-dependent kinase-like 5 deficiency'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0751494', 'cui_str': 'Seizures, Convulsive'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0537150', 'cui_str': 'ganaxolone'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0751494', 'cui_str': 'Seizures, Convulsive'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4750718', 'cui_str': 'Cyclin-dependent kinase-like 5 deficiency'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",114.0,0.708725,Treatment-emergent adverse events occurred in 43 (86%) of 50 patients in the ganaxolone group and in 45 (88%) of 51 patients in the placebo group.,"[{'ForeName': 'Elia M Pestana', 'Initials': 'EMP', 'LastName': 'Knight', 'Affiliation': 'Epilepsy Center, Cleveland Neurological Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address: pestane@ccf.org.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Pediatric Neurology, University Hospitals Bristol and Weston, Bristol, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bahi-Buisson', 'Affiliation': 'Pediatric Neurology, Necker Enfants Malades University Hospital, Paris, France.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Benke', 'Affiliation': ""Department of Pediatrics and Neurology, University of Colorado School of Medicine, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'J Helen', 'Initials': 'JH', 'LastName': 'Cross', 'Affiliation': 'UCL NIHR BRC Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Demarest', 'Affiliation': ""Department of Pediatrics and Neurology, University of Colorado School of Medicine, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Olson', 'Affiliation': ""Division of Epilepsy and Clinical Neurophysiology and Epilepsy Genetics Program, Department of Neurology, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Specchio', 'Affiliation': ""Rare and Complex Epilepsy Unit, Department of Neuroscience, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Fleming', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Aimetti', 'Affiliation': 'Marinus Pharmaceuticals, Radnor, PA, USA.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Gasior', 'Affiliation': 'Marinus Pharmaceuticals, Radnor, PA, USA.'}, {'ForeName': 'Orrin', 'Initials': 'O', 'LastName': 'Devinsky', 'Affiliation': 'New York University Langone Comprehensive Epilepsy Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(22)00077-1']
772,35430502,Effects of oxytocin and vasopressin administration on human fathers' sensitive and challenging parenting: A randomized within-subject controlled trial.,"This randomized, double-blind, placebo-controlled within-subject study examined the effects of intranasal administration of oxytocin and vasopressin on fathers' sensitive and challenging parenting behaviors. Furthermore, we examined the moderating role of fathers' early childhood experiences. The sample consisted of 70 fathers with their 2- to 12-month-old infants. All fathers were assigned to each of the three experimental sessions (oxytocin, vasopressin, and placebo), on three separate days, with random order and intervening periods of one to two weeks. Sensitive and challenging parenting behaviors (CPB) were observed during a 10-minute free play task. Results showed no effects of vasopressin administration on paternal sensitivity. Fathers in the oxytocin condition were less sensitive than fathers in the placebo condition, and this effect was moderated by fathers' own childhood experiences: Fathers who reported higher levels of experienced parental love withdrawal were less sensitive in the oxytocin condition as compared to the placebo condition, whereas fathers with less experienced parental love withdrawal showed no difference in sensitivity between the oxytocin and placebo condition. No effects were found of oxytocin and vasopressin administration on fathers' CPB. Our results, although partly unexpected, are largely in line with previous literature showing that oxytocin administration can exert negative effects in individuals with adverse childhood experiences.",2022,"Fathers who reported higher levels of experienced parental love withdrawal were less sensitive in the oxytocin condition as compared to the placebo condition, whereas fathers with less experienced parental love withdrawal showed no difference in sensitivity between the oxytocin and placebo condition.","[""human fathers' sensitive and challenging parenting"", '70 fathers with their 2- to 12-month-old infants', ""fathers' own childhood experiences"", 'individuals with adverse childhood experiences', ""fathers' sensitive and challenging parenting behaviors"", ""fathers' early childhood experiences""]","['vasopressin', 'oxytocin', 'experimental sessions (oxytocin, vasopressin, and placebo', 'oxytocin and vasopressin', 'placebo']","['Sensitive and challenging parenting behaviors (CPB', 'paternal sensitivity', 'sensitivity']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}]","[{'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0337493', 'cui_str': 'Paternal'}]",70.0,0.140408,"Fathers who reported higher levels of experienced parental love withdrawal were less sensitive in the oxytocin condition as compared to the placebo condition, whereas fathers with less experienced parental love withdrawal showed no difference in sensitivity between the oxytocin and placebo condition.","[{'ForeName': 'Annemieke M', 'Initials': 'AM', 'LastName': 'Witte', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, the Netherlands. Electronic address: a.m.witte@vu.nl.'}, {'ForeName': 'Marleen H M', 'Initials': 'MHM', 'LastName': 'de Moor', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Majdandžić', 'Affiliation': 'Research Institute of Child Development and Education, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Martine W F T', 'Initials': 'MWFT', 'LastName': 'Verhees', 'Affiliation': 'Quantitative Psychology and Individual Differences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Marinus H', 'Initials': 'MH', 'LastName': 'van IJzendoorn', 'Affiliation': 'Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam, Rotterdam, the Netherlands; Research Department of Clinical, Education and Health Psychology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'Bakermans-Kranenburg', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioral and Movement Sciences, Vrije Universiteit, Amsterdam, the Netherlands; Leiden Institute for Brain and Cognition, Leiden University Medical Center, Leiden, the Netherlands.'}]",Hormones and behavior,['10.1016/j.yhbeh.2022.105175']
773,35434911,Effects of intervention on lifestyle changes among coronary artery disease patients: A 6-month follow-up study.,"AIM


The main aim of the study was to investigate the effects of a nurse-led lifestyle-related risk factor modification intervention on multiple lifestyle behaviours among coronary artery disease patients over six months.
DESIGN


A pre-test post-test control group design was conducted in a single clinical centre in Nepal.
METHODS


A total of 224 eligible patients were randomly assigned to either the usual care group or the intervention group at baseline. The lifestyle intervention consisted of a brief counselling session supplemented with informational leaflets. Standard questionnaires were used to collect self-reported data from patients on multiple lifestyle behaviours: diet, physical activity, adherence to medication, stress, body mass index, smoking and alcohol consumption. General linear model repeated measure analysis was used to estimate the effect of intervention.
RESULTS


A statistically significant effect of study group-by-time interaction for diet, adherence to medication, physical activity, and perceived stress was found at 6-month follow-up. Overall, greater improvement in lifestyle habits was found in the intervention group compared with the control group at 6-month follow-up.",2022,"Overall, greater improvement in lifestyle habits was found in the intervention group compared with the control group at 6-month follow-up.","['coronary artery disease patients', 'coronary artery disease patients over six months', '224 eligible patients']","['nurse-led lifestyle-related risk factor modification intervention', 'brief counselling session supplemented with informational leaflets']","['diet, adherence to medication, physical activity, and perceived stress', 'multiple lifestyle behaviours', 'lifestyle habits', 'lifestyle changes']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C4319560', 'cui_str': '224'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",224.0,0.00568343,"Overall, greater improvement in lifestyle habits was found in the intervention group compared with the control group at 6-month follow-up.","[{'ForeName': 'Pramila', 'Initials': 'P', 'LastName': 'Gaudel', 'Affiliation': 'Unit of Health Sciences, Nursing Science, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Subas', 'Initials': 'S', 'LastName': 'Neupane', 'Affiliation': 'Unit of Health Sciences, Epidemiology, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Anna-Maija', 'Initials': 'AM', 'LastName': 'Koivisto', 'Affiliation': 'Unit of Health Sciences, Biostatistics, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Kaunonen', 'Affiliation': 'Unit of Health Sciences, Nursing Science, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rantanen', 'Affiliation': 'Unit of Health Sciences, Nursing Science, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}]",Nursing open,['10.1002/nop2.1212']
774,35436911,Effects of providing free hearing aids on multiple health outcomes among middle-aged and older adults with hearing loss in rural China: a randomized controlled trial.,"BACKGROUND


Hearing loss has been associated with serious health problems around the globe. Previous studies have found the positive effects of fitting hearing aids on health, but few studies were conducted in developing countries. The aim of this study is to examine the effects of hearing aids on multiple health outcomes among middle-aged and older adults with hearing loss in rural China.
METHODS


In this randomized controlled trial (RCT), participants aged 45 and above were randomly assigned to the treatment group prescribing with hearing aids or to the control group with no intervention. Trial outcomes for 385 participants were collected during the 20-month follow-up study. Using the difference-in-difference approach, our primary outcomes were hearing-related quality of life (QoL) and generic QoL.
RESULTS


The intervention led to improvements in hearing-related QoL, presenting as the reduction in Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) scores (interaction coefficient = - 2.86, p = 0.005), HHIE-S-Emotional scores (interaction coefficient = - 1.42, p = 0.029), and HHIE-S-Situational scores (interaction coefficient = - 1.43, p = 0.007). The intervention was also effective in alleviating the increase in depressive symptoms (interaction coefficient = - 0.14, p = 0.042). Subgroup analysis revealed that the effects were only shown among people with social activities or active social networks.
CONCLUSIONS


Our study is the first RCT in China to measure the health effects and heterogeneity of hearing aid interventions. Wearing hearing aids can help improve hearing-related QoL and alleviate the increase in depressive symptoms. The intervention is expected to be applicable to similar settings in other developing countries to combat hearing-related health problems.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900024739 . Registered on 26 July 2019.",2022,"The intervention was also effective in alleviating the increase in depressive symptoms (interaction coefficient = - 0.14, p = 0.042).","['participants aged 45 and above', '385 participants were collected during the 20-month follow-up study', 'middle-aged and older adults with hearing loss in rural China']","['hearing aids or to the control group with no intervention', 'hearing aids', 'free hearing aids']","['social activities or active social networks', 'hearing-related quality of life (QoL) and generic QoL', 'hearing-related QoL, presenting as the reduction in Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) scores', 'depressive symptoms', 'multiple health outcomes', 'HHIE-S-Situational scores', 'HHIE-S-Emotional scores']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451212', 'cui_str': 'Hearing handicap inventory for the elderly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",385.0,0.0770675,"The intervention was also effective in alleviating the increase in depressive symptoms (interaction coefficient = - 0.14, p = 0.042).","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'China Center for Health Development Studies, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'China Center for Health Development Studies, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'China Center for Health Development Studies, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'School of Management, Beijing University of Chinese Medicine, 11 North 3rd Ring Road East, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gong', 'Affiliation': 'China Rehabilitation Research Center for Hearing and Speech Impairment, No. 8 Huixinli A, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Juncheng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Linyi Center for Disease Control and Prevention, 3 Beijing Road, Beicheng New District, Linyi City, 276007, Shandong, China.'}, {'ForeName': 'Huibin', 'Initials': 'H', 'LastName': 'Zuo', 'Affiliation': 'Linyi Center for Disease Control and Prevention, 3 Beijing Road, Beicheng New District, Linyi City, 276007, Shandong, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'China Center for Health Development Studies, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China. phe@pku.edu.cn.'}]",BMC medicine,['10.1186/s12916-022-02323-2']
775,35442963,A workplace Acceptance and Commitment Therapy (ACT) intervention for improving healthcare staff psychological distress: A randomised controlled trial.,"The levels of psychological distress and burnout among healthcare staff are high, with negative implications for patient care. A growing body of evidence indicates that workplace programmes based on Acceptance and Commitment Therapy (ACT) are effective for improving employees' general psychological health. However, there is a paucity of research examining the specific psychological and/or behavioural processes through which workplace ACT programmes transmit their beneficial effects. The aim of this randomised controlled trial was to investigate the outcomes and putative processes of change in a 4-session ACT training programme designed to reduce psychological distress among healthcare staff (n = 98). Ninety-eight employees of a healthcare organisation were randomly allocated to the ACT intervention or to a waiting list control group. Study measures were administered on four occasions (baseline, mid-intervention, post-intervention, and follow-up) over a three-month evaluation period. Results showed that the ACT intervention led to a significant decrease in symptoms of psychological distress and a less pronounced reduction in burnout. These effects were mediated primarily via an improvement in mindfulness skills and values-based behaviour and moderated by participants' initial levels of distress. At four-week post-intervention, 48% of participants who received the ACT intervention showed reliable improvements in psychological distress, with just under half of the aforementioned improvements (46.15%) meeting criteria for clinically significant change. The results advance ACT as an effective stress management intervention for healthcare staff. The findings should be confirmed in a large scale randomised controlled trial with longer follow-up and cost-effectiveness analyses.",2022,Results showed that the ACT intervention led to a significant decrease in symptoms of psychological distress and a less pronounced reduction in burnout.,"['Ninety-eight employees of a healthcare organisation', 'healthcare staff psychological distress', 'healthcare staff (n = 98']","['workplace Acceptance and Commitment Therapy (ACT) intervention', 'ACT intervention', '4-session ACT training programme', 'ACT intervention or to a waiting list control group']","['symptoms of psychological distress', 'levels of psychological distress', 'psychological distress', ""mindfulness skills and values-based behaviour and moderated by participants' initial levels of distress""]","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",98.0,0.033491,Results showed that the ACT intervention led to a significant decrease in symptoms of psychological distress and a less pronounced reduction in burnout.,"[{'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Prudenzi', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Graham', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.""}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Flaxman', 'Affiliation': 'Department of Psychology, University of London, London, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wilding', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Day', 'Affiliation': 'Fiona Day Consulting LTD, Leeds, United Kingdom.'}, {'ForeName': 'Daryl B', 'Initials': 'DB', 'LastName': ""O'Connor"", 'Affiliation': 'School of Psychology, University of Leeds, Leeds, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0266357']
776,35443967,Implementation of virtual reality technology to decrease patients' pain and nervousness during colonoscopies: a prospective randomised controlled single-blinded trial.,"BACKGROUND


Improved patient satisfaction in endoscopy is worthy of study as it is an invasive and potentially uncomfortable procedure. There is growing literature on patient satisfaction assessment in endoscopy as part of improving quality assurance. This study aimed to determine whether virtual reality (VR) technology can decrease patients' pain and nervousness during colonoscopies.
METHODS


Patients enrolled without sedation were randomly categorised into groups that watched VR (VR group; n=58) and those that did not watch VR (control group; n=59). The primary outcomes were pain score and skin conductance. Secondary endpoints included heart rate, systolic and diastolic arterial pressures, overall patient satisfaction, willingness to repeat the procedure, the difficulty of the procedure, the procedure duration, and bowel preparation.
RESULTS


The median (interquartile range (IQR)) pain scores were 7 (6-8) and 5 (4-6) in the control and VR groups, respectively (p<0.001). The median (IQR) skin conductance values after colonoscope insertion were 0.660 (0.490-0.840) and 0.390 (0.280-0.600) in the control and VR groups, respectively (p<0.001). Overall, patient satisfaction was significantly improved with the use of VR, along with a significant reduction in the difficulty perceived by the endoscopist.
CONCLUSION


VR technology helped to reduce patients' pain and nervousness and to improve patients' satisfaction during colonoscopies.",2022,"Overall, patient satisfaction was significantly improved with the use of VR, along with a significant reduction in the difficulty perceived by the endoscopist.
","[""patients' pain and nervousness during colonoscopies"", 'Patients enrolled without sedation']","['virtual reality technology', 'virtual reality (VR) technology', 'watched VR (VR group; n=58) and those that did not watch VR']","['median (interquartile range (IQR', 'median (IQR) skin conductance values', 'Overall, patient satisfaction', 'pain scores', ""patients' pain and nervousness"", 'heart rate, systolic and diastolic arterial pressures, overall patient satisfaction, willingness to repeat the procedure, the difficulty of the procedure, the procedure duration, and bowel preparation', 'pain score and skin conductance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}]",,0.100351,"Overall, patient satisfaction was significantly improved with the use of VR, along with a significant reduction in the difficulty perceived by the endoscopist.
","[{'ForeName': 'Qizhi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Shanghai Fourth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yunhua', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Six One Primary School, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zang', 'Affiliation': 'Ministry of Education, Shanghai, China.'}, {'ForeName': 'Wenpeng', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Naval Medical University, Shanghai, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Ministry of Education, Shanghai, China.'}, {'ForeName': ""Ya'nan"", 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Ministry of Education, Shanghai, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xin', 'Affiliation': 'Naval Medical University, Shanghai, China.'}, {'ForeName': 'Xiaohuang', 'Initials': 'X', 'LastName': 'Tu', 'Affiliation': ""Shanghai Fourth People's Hospital, Shanghai, China tuxiaohuang@126.com.""}]","Clinical medicine (London, England)",['10.7861/clinmed.2022-0001']
777,35399053,The effects of vitamin D supplementation on frailty in older adults at risk for falls.,"BACKGROUND


Low serum 25-hydroxyvitamin D [25(OH)D] level is associated with a greater risk of frailty, but the effects of daily vitamin D supplementation on frailty are uncertain. This secondary analysis aimed to examine the effects of vitamin D supplementation on frailty using data from the Study To Understand Fall Reduction and Vitamin D in You (STURDY).
METHODS


The STURDY trial, a two-stage Bayesian, response-adaptive, randomized controlled trial, enrolled 688 community-dwelling adults aged ≥ 70 years with a low serum 25(OH)D level (10-29 ng/mL) and elevated fall risk. Participants were initially randomized to 200 IU/d (control dose; n = 339) or a higher dose (1000 IU/d, 2000 IU/d, or 4000 IU/d; n = 349) of vitamin D3. Once the 1000 IU/d was selected as the best higher dose, other higher dose groups were reassigned to the 1000 IU/d group and new enrollees were randomized 1:1 to 1000 IU/d or control group. Data were collected at baseline, 3, 12, and 24 months. Frailty phenotype was based on number of the following conditions: unintentional weight loss, exhaustion, slowness, low activity, and weakness (≥ 3 conditions as frail, 1 or 2 as pre-frail, and 0 as robust). Cox proportional hazard models estimated the risk of developing frailty, or improving or worsening frailty status at follow-up. All models were adjusted for demographics, health conditions, and further stratified by baseline serum 25(OH)D level (insufficiency (20-29 ng/mL) vs. deficiency (10-19 ng/mL)).
RESULTS


Among 687 participants (mean age 77.1 ± 5.4, 44% women) with frailty assessment at baseline, 208 (30%) were robust, 402 (59%) were pre-frail, and 77 (11%) were frail. Overall, there was no significant difference in risk of frailty outcomes comparing the pooled higher doses (PHD; ≥ 1000 IU/d) vs. 200 IU/d. When comparing each higher dose vs. 200 IU/d, the 2000 IU/d group had nearly double the risk of worsening frailty status (HR = 1.89, 95% CI: 1.13-3.16), while the 4000 IU/d group had a lower risk of developing frailty (HR = 0.22, 95% CI: 0.05-0.97). There were no significant associations between vitamin D doses and frailty status in the analyses stratified by baseline serum 25(OH)D level.
CONCLUSIONS


High dose vitamin D supplementation did not prevent frailty. Significant subgroup findings might be the results of type 1 error.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02166333 .",2022,"There were no significant associations between vitamin D doses and frailty status in the analyses stratified by baseline serum 25(OH)D level.
","['70\xa0years with a low serum 25(OH)D level (10-29\xa0ng/mL) and elevated fall risk', '687 participants (mean age 77.1\u2009±\u20095.4, 44% women) with frailty assessment at baseline, 208 (30%) were robust, 402 (59%) were pre-frail, and 77 (11%) were frail', 'older adults at risk for falls', '688 community-dwelling adults aged\u2009≥']","['vitamin D supplementation', 'vitamin D3']","['risk of frailty outcomes', 'risk of worsening frailty status', 'lower risk of developing frailty', 'unintentional weight loss, exhaustion, slowness, low activity, and weakness', 'vitamin D doses and frailty status']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C2363736', 'cui_str': 'Unintentional weight loss'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",688.0,0.741862,"There were no significant associations between vitamin D doses and frailty status in the analyses stratified by baseline serum 25(OH)D level.
","[{'ForeName': 'Yurun', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. yuc199@pitt.edu.'}, {'ForeName': 'Amal A', 'Initials': 'AA', 'LastName': 'Wanigatunga', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jacek K', 'Initials': 'JK', 'LastName': 'Urbanek', 'Affiliation': 'Center On Aging and Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University and Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Michos', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University and Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Kalyani', 'Affiliation': 'Center On Aging and Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Center On Aging and Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Schrack', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",BMC geriatrics,['10.1186/s12877-022-02888-w']
778,35403793,"Efficacy and safety of cotadutide, a dual glucagon-like peptide-1 and glucagon receptor agonist, in a randomized phase 2a study of patients with type 2 diabetes and chronic kidney disease.","AIM


To assess the efficacy, safety and tolerability of cotadutide in patients with type 2 diabetes mellitus and chronic kidney disease.
MATERIALS AND METHODS


In this phase 2a study (NCT03550378), patients with body mass index 25-45 kg/m 2  , estimated glomerular filtration rate 30-59 ml/min/1.73 m 2  and type 2 diabetes [glycated haemoglobin 6.5-10.5% (48-91 mmol/mol)] controlled with insulin and/or oral therapy combination, were randomized 1:1 to once-daily subcutaneous cotadutide (50-300 μg) or placebo for 32 days. The primary endpoint was plasma glucose concentration assessed using a mixed-meal tolerance test.
RESULTS


Participants receiving cotadutide (n = 21) had significant reductions in the mixed-meal tolerance test area under the glucose concentration-time curve (-26.71% vs. +3.68%, p < .001), more time in target glucose range on continuous glucose monitoring (+14.79% vs. -21.23%, p = .001) and significant reductions in absolute bodyweight (-3.41 kg vs. -0.13 kg, p < .001) versus placebo (n = 20). In patients with baseline micro- or macroalbuminuria (n = 18), urinary albumin-to-creatinine ratios decreased by 51% at day 32 with cotadutide versus placebo (p = .0504). No statistically significant difference was observed in mean change in estimated glomerular filtration rate between treatments. Mild/moderate adverse events occurred in 71.4% of participants receiving cotadutide and 35.0% receiving placebo.
CONCLUSIONS


We established the efficacy of cotadutide in this patient population, with significantly improved postprandial glucose control and reduced bodyweight versus placebo. Reductions in urinary albumin-to-creatinine ratios suggest potential benefits of cotadutide on kidney function, supporting further evaluation in larger, longer-term clinical trials.",2022,"Mild/ moderate adverse events occurred in 71.4% of participants receiving cotadutide and 35.0% receiving placebo.
","['patients with type 2 diabetes mellitus and chronic kidney disease (CKD', 'patients with type 2 diabetes and chronic kidney disease', 'patients with BMI 25-45 kg/m 2  , estimated glomerular filtration (eGFR) rate 30-59']","['insulin and/or oral therapy combination', 'cotadutide', 'cotadutide, a dual GLP-1 and glucagon receptor agonist', 'placebo']","['absolute bodyweight', 'mean change in eGFR', 'plasma glucose concentration assessed using a mixed-meal tolerance test (MMTT', 'efficacy, safety and tolerability', 'Mild/ moderate adverse events', 'postprandial glucose control', 'time in target glucose range on continuous glucose monitoring', 'urinary albumin-to-creatinine ratios (UACR', 'glucose concentration-time curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0061352', 'cui_str': 'Glucagon Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513374', 'cui_str': 'Common terminology criteria for adverse events grade 2'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.171078,"Mild/ moderate adverse events occurred in 71.4% of participants receiving cotadutide and 35.0% receiving placebo.
","[{'ForeName': 'Victoria E R', 'Initials': 'VER', 'LastName': 'Parker', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Thuong', 'Initials': 'T', 'LastName': 'Hoang', 'Affiliation': 'GW Pharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Schlichthaar', 'Affiliation': 'Study Center, SMO.MD GmbH, Magdeburg, Germany.'}, {'ForeName': 'Fraser W', 'Initials': 'FW', 'LastName': 'Gibb', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wenzel', 'Affiliation': 'APEX GmbH, Munich, Germany.'}, {'ForeName': 'Maximillian G', 'Initials': 'MG', 'LastName': 'Posch', 'Affiliation': 'Charite Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': 'Zentrum fur Diabetes, Münster, Germany.'}, {'ForeName': 'Yi-Ting', 'Initials': 'YT', 'LastName': 'Chang', 'Affiliation': 'Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Petrone', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hansen', 'Affiliation': 'Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ambery', 'Affiliation': 'Late Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Jermutus', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'McCrimmon', 'Affiliation': 'School of Medicine, Ninewells Hospital, University of Dundee, Dundee, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14712']
779,35397476,Sleep irregularity and nonsuicidal self-injurious urges and behaviors.,"STUDY OBJECTIVES


The objectives of this study were to examine the relationships between sleep regularity and nonsuicidal self-injury (NSSI), including lifetime NSSI history and daily NSSI urges.
METHODS


Undergraduate students (N = 119; 18-26 years), approximately half of whom endorsed a lifetime history of repetitive NSSI, completed a 10-day actigraphy and ecological momentary assessment (EMA) protocol. A Sleep Regularity Index was calculated for all participants using scored epoch by epoch data to capture rapid changes in sleep schedules. Participants responded to EMA prompts assessing NSSI urge severity and negative affect three times daily over the 10-day assessment period.
RESULTS


Results indicate that individuals with a repetitive NSSI history were more likely to experience sleep irregularity than those without a history of NSSI. Findings also suggest that sleep irregularity was associated with more intense urges to engage in NSSI on a daily basis, even after accounting for average daily sleep duration, sleep timing, negative affect, and NSSI history. Neither sleep duration nor sleep timing was associated with NSSI history nor daily NSSI urge intensity.
CONCLUSIONS


Findings suggest that sleep irregularity is linked with NSSI, including NSSI history and intensity of urges to engage in NSSI. The present study not only supports the growing evidence linking sleep disturbance with the risk for self-injury but also demonstrates this relationship using actigraphy and real-time assessments of NSSI urge severity. Findings highlight the importance of delineating the nuances in sleep irregularity that are proximally associated with NSSI risk and identifying targets for intervention.",2022,"Findings also suggest that sleep irregularity was associated with more intense urges to engage in NSSI on a daily basis, even after accounting for average daily sleep duration, sleep timing, negative affect, and NSSI history.","['Undergraduate students (N=119; 18-26 years), approximately half of whom endorsed a lifetime history of repetitive NSSI, completed a']","['10-day actigraphy and ecological momentary assessment (EMA) protocol', 'EMA']","['Sleep Irregularity and Nonsuicidal Self-injurious Urges and Behaviors', 'Sleep Regularity Index', 'sleep duration nor sleep timing', 'NSSI history nor daily NSSI urge intensity']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",119.0,0.0648568,"Findings also suggest that sleep irregularity was associated with more intense urges to engage in NSSI on a daily basis, even after accounting for average daily sleep duration, sleep timing, negative affect, and NSSI history.","[{'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Burke', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hamilton', 'Affiliation': 'Department of Psychology, Rutgers University, Piscataway, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Seigel', 'Affiliation': 'Graduate School of Applied and Professional Psychology, Rutgers University \xa0Piscataway, NJ, USA.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Kautz', 'Affiliation': 'Department of Psychology and Neuroscience, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Alloy', 'Affiliation': 'Department of Psychology and Neuroscience, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barker', 'Affiliation': 'Department of Psychiatry and Human Behavior, The Alpert Medical School of Brown University, Providence, RI, USA.'}]",Sleep,['10.1093/sleep/zsac084']
780,35404990,Cost-effectiveness of a structured medication review approach for multimorbid older adults: Within-trial analysis of the OPERAM study.,"BACKGROUND


Inappropriate polypharmacy has been linked with adverse outcomes in older, multimorbid adults. OPERAM is a European cluster-randomized trial aimed at testing the effect of a structured pharmacotherapy optimization intervention on preventable drug-related hospital admissions in multimorbid adults with polypharmacy aged 70 years or older. Clinical results of the trial showed a pattern of reduced drug-related hospital admissions, but without statistical significance. In this study we assessed the cost-effectiveness of the pharmacotherapy optimisation intervention.
METHODS


We performed a pre-planned within-trial cost-effectiveness analysis (CEA) of the OPERAM intervention, from a healthcare system perspective. All data were collected within the trial apart from unit costs. QALYs were computed by applying the crosswalk German valuation algorithm to EQ-5D-5L-based quality of life data. Considering the clustered structure of the data and between-country heterogeneity, we applied Generalized Structural Equation Models (GSEMs) on a multiple imputed sample to estimate costs and QALYs. We also performed analyses by country and subgroup analyses by patient and morbidity characteristics.
RESULTS


Trial-wide, the intervention was numerically dominant, with a potential cost-saving of CHF 3'588 (95% confidence interval (CI): -7'716; 540) and gain of 0.025 QALYs (CI: -0.002; 0.052) per patient. Robustness analyses confirmed the validity of the GSEM model. Subgroup analyses suggested stronger effects in people at higher risk.
CONCLUSION


We observed a pattern towards dominance, potentially resulting from an accumulation of multiple small positive intervention effects. Our methodological approaches may inform other CEAs of multi-country, cluster-randomized trials facing presence of missing values and heterogeneity between centres/countries.",2022,"Clinical results of the trial showed a pattern of reduced drug-related hospital admissions, but without statistical significance.","['older, multimorbid adults', 'multimorbid older adults', 'multimorbid adults with polypharmacy aged 70 years or older']",['structured pharmacotherapy optimization intervention'],"['cost-effectiveness', 'Cost-effectiveness']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.115097,"Clinical results of the trial showed a pattern of reduced drug-related hospital admissions, but without statistical significance.","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Salari', 'Affiliation': 'Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.'}, {'ForeName': 'Cian', 'Initials': 'C', 'LastName': ""O'Mahony"", 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Henrard', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Paco', 'Initials': 'P', 'LastName': 'Welsing', 'Affiliation': 'Division of Internal Medicine and Dermatology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Bhadhuri', 'Affiliation': 'Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Schur', 'Affiliation': 'Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Roumet', 'Affiliation': 'Clinical Trial Unit Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Beglinger', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Beck', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Katharina Tabea', 'Initials': 'KT', 'LastName': 'Jungo', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hossmann', 'Affiliation': 'Clinical Trial Unit Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Knol', 'Affiliation': 'Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""O'Mahony"", 'Affiliation': 'Department of Medicine (Geriatrics), University College Cork, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Spinewine', 'Affiliation': 'Institute of Health and Society (IRSS), UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwenkglenks', 'Affiliation': 'Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.'}]",PloS one,['10.1371/journal.pone.0265507']
781,35410145,The short-term effect of a modified comprehensive geriatric assessment and regularly case conferencing on neuropsychiatric symptoms in nursing homes: a cluster randomized trial.,"AIMS


To investigate the short-term effect of implementing a modified comprehensive geriatric assessment and regularly case conferencing in nursing homes on neuropsychiatric symptoms.
BACKGROUND


Neuropsychiatric symptoms are common and may persist over time in nursing home residents. Evidence of effective interventions is scarce.
DESIGN


A parallel cluster-randomised controlled trial.
METHODS


The intervention was monthly standardised case conferencing in combination with a modified comprehensive geriatric assessment. The control group received care as usual.
MAIN OUTCOME MEASURE


The total score on the short version of the Neuropsychiatric Inventory (NPI-Q, 12-items).
RESULTS


A total of 309 residents at 34 long-term care wards in 17 nursing homes (unit of randomisation) were included. The intervention care units conducted on average two case conference-meetings (range 1-3), discussing a mean of 4.8 (range 1-8) residents. After 3 months, there were no difference of NPI-Q total score between the intervention (-0.4) and the control group (0.5) (estimated mean difference = -1.0, 95% CI -2.4 to 0.5, p = 0.19). There was a difference in favour of the intervention group on one of the secondary outcome measures, the apathy symptoms (-0.5 95% CI: -0.9 to -0.1, p = 0.03).
CONCLUSION


In this study there were no short-term effect of case conferencing and modified comprehensive geriatric assessments after three months on the total score on neuropsychiatric symptoms. The intervention group had less apathy at 3 months follow-up compared to those receiving care as usual. The findings suggest that a more comprehensive intervention is needed to improve the total Neuropsychiatric symptoms burden and complex symptoms.
TRIAL REGISTRATION


Due to delays in the organisation, the study was registered after study start, i.e. retrospectively in Clinicaltrials.gov # NCT02790372 at  https://clinicaltrials.gov/ ; Date of clinical trial registration: 03/06/2016.",2022,In this study there were no short-term effect of case conferencing and modified comprehensive geriatric assessments after three months on the total score on neuropsychiatric symptoms.,"['nursing homes on neuropsychiatric symptoms', '309 residents at 34 long-term care wards in 17 nursing\xa0homes (unit of randomisation) were included', 'nursing homes']","['standardised case conferencing in combination with a modified comprehensive geriatric assessment', 'implementing a modified comprehensive geriatric assessment and regularly case conferencing', 'modified comprehensive geriatric assessment and regularly case conferencing']","['neuropsychiatric symptoms', 'NPI-Q total score', 'total Neuropsychiatric symptoms burden and complex symptoms', 'apathy symptoms']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}]",309.0,0.136134,In this study there were no short-term effect of case conferencing and modified comprehensive geriatric assessments after three months on the total score on neuropsychiatric symptoms.,"[{'ForeName': 'Geir-Tore', 'Initials': 'GT', 'LastName': 'Stensvik', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. geir.t.stensvik@ntnu.no.'}, {'ForeName': 'Anne-Sofie', 'Initials': 'AS', 'LastName': 'Helvik', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Gørill', 'Initials': 'G', 'LastName': 'Haugan', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Aslak', 'Initials': 'A', 'LastName': 'Steinsbekk', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Nakrem', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",BMC geriatrics,['10.1186/s12877-022-02976-x']
782,35413787,Efficiency of laryngeal mask airway ProtectorTM and i-gel® as a conduit in Aintree catheter-guided fibreoptic tracheal intubation: a randomised clinical trial.,"BACKGROUND


Fibreoptic intubation through a supraglottic airway device (SAD) is recom-mended in difficult airway management algorithms. The Difficult Airway Society published a guideline describing the details of this technique in 2011. This study was designed to compare the efficiency of two different 2nd generation SADs as a conduit for Aintree catheter-guided fibreoptic tracheal intubation.
METHODS


80 adult patients with an ASA score of 1-3 undergoing elective surgical procedures were included in the study. The patients were intubated after randomization to two groups: the i-gel group and the laryngeal mask airway (LMA) Protector group. SAD insertion time and tracheal intubation time were recorded separately. Demographic data, changes in haemodynamic parameters during the procedure, and complications were noted.
RESULTS


In the LMA Protector and i-gel groups, the number of attempts (1.14 ± 0.35 vs. 1.24 ± 0.49 times, P = 0.394), device insertion time (14.89 ± 8.11 vs. 17.84 ± 16.59 seconds, P = 0.896), and the need for an optimization manoeuvre (43.2% vs. 37.8%, P = 0.813) were similar (P > 0.05). The fibreoptic laryngeal appearance scale and haemodynamic parameters were similar (P > 0.05). However, the airway complication rate was significantly higher in the LMA Protector group than in the i-gel group (21.6% vs. 2.7%, P = 0.013). The most common complications were bronchospasm and bloody secretion on SAD.
CONCLUSIONS


With the stable haemodynamic parameters, acceptable insertion time and lower complication rate, we concluded that the i-gel may be preferable in fibre-optic tracheal intubation. The rigid structure of the LMA Protector compared to the i-gel might contribute to this result.",2022,"However, the airway complication rate was significantly higher in the LMA Protector group than in the i-gel group (21.6% vs. 2.7%, P = 0.013).","['Aintree catheter-guided fibreoptic tracheal intubation', '80 adult patients with an ASA score of 1-3 undergoing elective surgical procedures were included in the study']","['laryngeal mask airway ProtectorTM and i-gel®', 'LMA Protector', 'i-gel group and the laryngeal mask airway (LMA', 'Fibreoptic intubation through a supraglottic airway device (SAD']","['need for an optimization manoeuvre', 'SAD insertion time and tracheal intubation time', 'acceptable insertion time and lower complication rate', 'fibreoptic laryngeal appearance scale and haemodynamic parameters', 'airway complication rate', 'bronchospasm and bloody secretion on SAD', 'device insertion time']","[{'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",80.0,0.0368397,"However, the airway complication rate was significantly higher in the LMA Protector group than in the i-gel group (21.6% vs. 2.7%, P = 0.013).","[{'ForeName': 'Kemal T', 'Initials': 'KT', 'LastName': 'Saracoglu', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Kartal Dr. Lütfi Kırdar Research and Education Hospital, Health Sciences University, Istanbul, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Derince Research and Education Hospital, Health Sciences University, Kocaeli, Turkey.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Aydas', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Derince Research and Education Hospital, Health Sciences University, Kocaeli, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Derince Research and Education Hospital, Health Sciences University, Kocaeli, Turkey.'}]",Anaesthesiology intensive therapy,['10.5114/ait.2022.115366']
783,35417452,Contribution of cardio-vascular risk factors to depressive status in the PREDIMED-PLUS Trial. A cross-sectional and a 2-year longitudinal study.,"BACKGROUND


Cardio-vascular disease and depression are thought to be closely related, due to shared risk factors. The aim of the study was to determine the association between cardio-vascular risk (CVR) factors and depressive status in a population (55-75 years) with metabolic syndrome (MetS) from the PREDIMED-Plus trial.
METHODS AND FINDINGS


Participants were classified into three groups of CVR according to the Framingham-based REGICOR function: (1) low (LR), (2) medium (MR) or (3) high/very high (HR). The Beck Depression Inventory-II (BDI-II) was used to assess depressive symptoms at baseline and after 2 years. The association between CVR and depressive status at baseline (n = 6545), and their changes after 2 years (n = 4566) were evaluated through multivariable regression models (logistic and linear models). HR women showed higher odds of depressive status than LR [OR (95% CI) = 1.78 (1.26, 2.50)]. MR and HR participants with total cholesterol <160 mg/mL showed higher odds of depression than LR [OR (95% CI) = 1.77 (1.13, 2.77) and 2.83 (1.25, 6.42) respectively)] but those with total cholesterol ≥280 mg/mL showed lower odds of depression than LR [OR (95% CI) = 0.26 (0.07, 0.98) and 0.23 (0.05, 0.95), respectively]. All participants decreased their BDI-II score after 2 years, being the decrease smaller in MR and HR diabetic compared to LR [adjusted mean±SE = -0.52±0.20, -0.41±0.27 and -1.25±0.31 respectively). MR and HR participants with total cholesterol between 240-279 mg/mL showed greater decreases in the BDI-II score compared to LR (adjusted mean±SE = -0.83±0.37, -0.77±0.64 and 0.97±0.52 respectively).
CONCLUSIONS


Improving cardiovascular health could prevent the onset of depression in the elderly. Diabetes and total cholesterol in individuals at high CVR, may play a specific role in the precise response. International Standard Randomized Controlled Trial (ISRCTN89898870).",2022,"MR and HR participants with total cholesterol between 240-279 mg/mL showed greater decreases in the BDI-II score compared to LR (adjusted mean±SE = -0.83±0.37, -0.77±0.64 and 0.97±0.52 respectively).
","['Participants were classified into three groups of CVR according to the Framingham-based REGICOR function: (1) low (LR), (2) medium (MR) or (3) high/very high (HR', 'a population (55-75 years) with metabolic syndrome (MetS']",[],"['CVR and depressive status', 'BDI-II score', 'depressive status', 'cardio-vascular risk (CVR) factors and depressive status', 'MR and HR diabetic', 'total cholesterol', 'Beck Depression Inventory-II (BDI-II', 'depressive symptoms']","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",[],"[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",4566.0,0.149988,"MR and HR participants with total cholesterol between 240-279 mg/mL showed greater decreases in the BDI-II score compared to LR (adjusted mean±SE = -0.83±0.37, -0.77±0.64 and 0.97±0.52 respectively).
","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Martín-Peláez', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Cano-Ibáñez', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Lassale', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Jose Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Ángel M', 'Initials': 'ÁM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'Centro de Investigación Biomédica en Red Epidemiología y Salud Pública (CIBERESP), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Miranda', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Fernández-Aranda', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Bueno-Cavanillas', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martín', 'Affiliation': 'Centro de Investigación Biomédica en Red Epidemiología y Salud Pública (CIBERESP), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Delgado-Rodríguez', 'Affiliation': 'Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Matía', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'CIBER Diabetes y Enfermedades Metabólicas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Vázquez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Fundación Jiménez-Díaz, Instituto de Investigaciones Biomédicas IISFJD. University Autónoma, Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Genomics and Epigenomics Group, IMDEA Food, CEI UAM + CSIC, Madrid, Spain.'}, {'ForeName': 'Emili', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Nishi', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Jose V', 'Initials': 'JV', 'LastName': 'Sorli', 'Affiliation': 'Department of Preventive Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Malcampo', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), Barcelona, Spain.""}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Zulet', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Anaí', 'Initials': 'A', 'LastName': 'Moreno-Rodríguez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Cueto-Galán', 'Affiliation': 'Department of Nursing, School of Health Sciences. University of Malaga- Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Vivancos-Aparicio', 'Affiliation': 'Centro Salud San Vicente 1, Alicante, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Colom', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Ríos', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Department of Internal Medicine, Institut dÌnvestigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'M Rosa', 'Initials': 'MR', 'LastName': 'Bernal-López', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Jose Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Zenaida', 'Initials': 'Z', 'LastName': 'Vázquez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gómez-Martínez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ortega-Azorín', 'Affiliation': 'Department of Preventive Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Jose Luís', 'Initials': 'JL', 'LastName': 'Del Val', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Abete', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Goikoetxea-Bahon', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pascual', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Becerra-Tomás', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Chillarón', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Sánchez-Villegas', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}]",PloS one,['10.1371/journal.pone.0265079']
784,35417788,"Assessment of push-out bond strength of post-surface pretreatment before salinization using hydrogen peroxide, aluminum trioxide, and natural photosensitizers to radicular dentin.","OBJECTIVE


The study aimed to evaluate the effect of different post surface pretreatment methods i.e., 24% hydrogen peroxide (H 2 O 2 ), riboflavin photosensitizer (RFP), curcumin photosensitizer (CP) and aluminum oxide (Al 2 O 3 ), and silane only on the bond values of glass fiber post to resin cement MATERIALS AND METHODS: Fifty single-rooted human teeth were obtained and crowns were sectioned coronally to the cementoenamel junction (CEJ). Protaper universal file system was used for canal cleaning and shaping followed by obturation. Post space was prepared and all the posts were then randomly divided into five groups depending on the surface pretreatment used (n = 10). Group 1: 24% H 2 O 2  + silane, Group 2: RFP + silane, Group 3: CP + silane, Group 4: Al 2 O 3  + silane, Group 5: silane only. Post-surface treatment was followed by post-placement using a self-etch dual-cure cement Panavia F 2.0. Acrylic blocks were used to hold the specimens perpendicularly and all the samples were sectioned by slow-speed saw into coronal, middle, and apical third. The universal testing machine determines pushout bond strength and failure mode was analyzed by stereomicroscope. One-way analysis of variance (ANOVA) and Tukey multiple comparison tests were used to analyze data.
RESULT


The coronal section of group 4 (Al 2 O 3  + silane) displayed the highest PBS (8.23±0.14 MPa). Whereas, an apical third of group 2 (RFP + silane) exhibited the lowest PBS (2.02±0.12 MPa). PBS values in samples in group 1 surface treated with 24% H 2 O 2  + silane displayed comparable outcomes to samples in group 4 at all three levels (p>0.05). Samples in group 2 (RFP + silane) group 3 (CP + silane) and group 5 (Silane Only) demonstrated comparable PBS (p>0.05).
CONCLUSION


Glass fiber reinforced post-surface pretreatment method using hydrogen peroxide and aluminum trioxide along with silane improves push-out bond strength at all three levels (coronal, middle, and apical). The use of a silane coupling agent on glass fiber posts alone does not improve bond values. The practice of photosensitizer on post-surface needs to be investigated further.",2022,PBS values in samples in group 1 surface treated with 24% H 2 O 2  + silane displayed comparable outcomes to samples in group 4 at all three levels (p>0.05).,[' Fifty single-rooted human teeth were obtained and crowns were sectioned coronally to the cementoenamel junction (CEJ'],"['hydrogen peroxide (H 2 O 2 ), riboflavin photosensitizer (RFP), curcumin photosensitizer (CP) and aluminum oxide', 'hydrogen peroxide and aluminum trioxide', 'hydrogen peroxide, aluminum trioxide, and natural photosensitizers to radicular dentin', 'RFP\u202f+\u202fsilane, Group 3: CP\u202f+\u202fsilane, Group 4: Al 2 O 3 \u202f+\u202fsilane, Group 5: silane only', 'RFP\u202f+\u202fsilane) group 3 (CP\u202f+\u202fsilane']","['PBS values', 'bond values', 'push-out bond strength']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0227011', 'cui_str': 'Structure of cementoenamel junction'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0002374', 'cui_str': 'Aluminum Oxide'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0037093', 'cui_str': 'Silanes'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0580841', 'cui_str': 'Does push'}]",,0.0162486,PBS values in samples in group 1 surface treated with 24% H 2 O 2  + silane displayed comparable outcomes to samples in group 4 at all three levels (p>0.05).,"[{'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Qamar', 'Affiliation': 'Department of OMFS and Diagnostic Sciences, Faculty of Dentistry, Riyadh Elm University, Riyadh, Saudi Arabia and Department of Oral Biology, Liaquat College of Medicine and Dentistry, Karachi, Pakistan. Electronic address: zeeshan.qamar@ymail.com.'}, {'ForeName': 'Nishath Sayed', 'Initials': 'NS', 'LastName': 'Abdul', 'Affiliation': 'Department of OMFS and Diagnostic Sciences, Faculty of Dentistry, Riyadh Elm University, Riyadh, Saudi Arabia. Electronic address: nishathsayed@riyadh.edu.sa.'}, {'ForeName': 'Saqib', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Biomedical Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. Electronic address: drsaqiibali@gmail.com.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'AlSheikh', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. Electronic address: ralshiekh@iau.edu.sa.'}, {'ForeName': 'Firas K', 'Initials': 'FK', 'LastName': 'Alqarawi', 'Affiliation': 'Substitutive Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, Saudi Arabia. Electronic address: fkalqarawi@iau.edu.sa.'}, {'ForeName': 'Fayez Hussain', 'Initials': 'FH', 'LastName': 'Niazi', 'Affiliation': 'Dept of Restorative and Prosthetic Dentistry College of Dentistry Dar Al Uloom University Riyadh, Saudi Arabia. Electronic address: fayez.h@dau.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2022.102859']
785,35420589,Targeting Anxiety to Improve Sleep Disturbance: A Randomized Clinical Trial of App-Based Mindfulness Training.,"OBJECTIVE


Sleep disturbance is experienced by nearly 20% of Americans and is highly comorbid with anxiety. Sleep disturbances may predict the development of anxiety disorders. Mindfulness training (MT) has shown efficacy for anxiety yet remains limited by in-person-based delivery. Digitally delivered MT may target habitual worry processes, yet its effects on sleep have not been studied. This study tested if app-based MT for anxiety could reduce worry and improve sleep and examined the underlying mechanisms.
METHODS


Individuals reporting worry interfering with sleep were randomized to treatment as usual (TAU; n = 40) or TAU + app-based MT (n = 40). Treatment-related changes in worry-related sleep disturbances (WRSDs), worry, nonreactivity, and anxiety were evaluated via self-report questionnaires at 1 and 2 months after treatment initiation. Fitbit devices were used to record total sleep time and estimate sleep efficiency. At 2 months, TAU received access to app-based MT, and both groups were reassessed at 4 months.
RESULTS


In a modified intent-to-treat analysis, WRSD scores decreased by 27% in TAU + MT (n = 36) and 6% in TAU (n = 35) at 2 months (median [IQR] change = 11 [4.3] versus 15 [5.0], p = .001). These WRSD reductions were mediated by decreased worry, particularly improved nonreactivity (p values < .001). At 4 months, TAU reported a significant 29% reduction after beginning app-based MT at 2 months and TAU + MT maintained its gains. No significant between-group differences in average estimated total sleep time or sleep efficiency were found after 2 months of using the app.
CONCLUSIONS


Few mindfulness-related apps have been evaluated for clinical efficacy and/or mechanism. Results from this study demonstrate a mechanistic link between MT and increased emotional nonreactivity, decreased worry, and reduction in reported sleep disturbances, suggesting that app-based MT may be a viable option to help individuals who report that worry interferes with their sleep.Trial Registration: ClinicalTrials.gov identifier: NCT03684057.",2022,"These WRSD reductions were mediated by decreased worry, particularly improved non-reactivity (P's < .001).",['Individuals reporting worry interfering with sleep'],"['TAU+MT', 'TAU + app-based MT', 'Mindfulness training (MT']","['total sleep time (TST) and estimate sleep efficiency (SE', 'worry-related sleep disturbances (WRSD), worry, non-reactivity, and anxiety', 'non-reactivity', 'average estimated TST or SE', 'Sleep', 'WRSD reductions', 'sleep disturbance', 'WRSD scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0430293,"These WRSD reductions were mediated by decreased worry, particularly improved non-reactivity (P's < .001).","[{'ForeName': 'May', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'From the Mindfulness Center, Brown University School of Public Health and Warren Alpert School of Medicine (Gao, Roy, Deluty, Brewer); Department of Medicine (Sharkey), Warren Alpert School of Medicine at Brown University, Providence, Rhode Island; Department of Psychiatry (Hoge), Georgetown University Medical Center, Washington, DC; Department of Biostatistics (Liu), Brown University School of Public Health; and Department of Psychiatry (Sharkey, Brewer), Warren Alpert School of Medicine at Brown University, Providence, Rhode Island.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Deluty', 'Affiliation': ''}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Sharkey', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hoge', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Judson A', 'Initials': 'JA', 'LastName': 'Brewer', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000001083']
786,35421017,Feasibility and Research Insights From a Randomized Controlled Trial for Recurrent Urinary Tract Infection Prevention in Postmenopausal Women Using Vaginal Estrogen Therapy.,"OBJECTIVE


The aim of the study was to inform feasibility parameters (eligibility, enrollment, and retention) for a recurrent urinary tract infection (rUTI) prevention randomized controlled trial (RCT).
METHODS


We assessed feasibility parameters of an RCT of postmenopausal women with uncomplicated rUTIs using vaginal estrogen. Participants were randomized to either d-mannose or a control arm. All participants were required to be using vaginal estrogen and to have a negative urine culture before 90-day trial participation. An RCT exit survey and separate survey for UTI patients (N = 196) were added to inform feasibility parameters and patient preferences for rUTI prevention and study participation after slower enrollment than anticipated.
RESULTS


At the time of interim and subsequent futility analyses, 545 patients had been evaluated for frequent/recurrent UTIs from March 1, 2018, to January 18, 2020. Of these, 213 (39.1%) had culture-proven rUTIs and 71 (33.3% of those with culture-proven rUTIs) were eligible for the RCT. Reasons for ineligibility included complicated UTIs, premenopausal/perimenopausal status, or existing UTI prevention regimen. Of the 71 eligible participants, 57 (80.3%) enrolled, and 44 began their planned 90-day study period (77.2%; 80.0% after excluding 2 participants awaiting negative urine cultures at the time of analysis). The study was halted before conclusion. Study retention (76.0%-83.7%) was slightly lower than expected. Urinary tract infection survey patients demonstrated significant interest in rUTI research participation.
CONCLUSIONS


We learned several important lessons that can benefit future research. Many patients with frequent/recurrent UTIs are interested in research, but rigorous eligibility criteria and referral urine culture documentation made recruitment challenging.",2022,Study retention (76.0%-83.7%) was slightly lower than expected.,"['postmenopausal women with uncomplicated rUTIs using vaginal estrogen', '71 eligible participants, 57 (80.3%) enrolled, and 44 began their planned 90-day study period (77.2%; 80.0% after excluding 2 participants awaiting negative urine cultures at the time of analysis', 'UTI patients (N = 196', 'Postmenopausal Women', 'Many patients with frequent/recurrent UTIs', 'All participants were required to be using vaginal estrogen and to have a negative urine culture before 90-day trial participation']",['Vaginal Estrogen Therapy'],[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C1522570', 'cui_str': 'Vaginal route'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0430404', 'cui_str': 'Urine culture'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],196.0,0.172118,Study retention (76.0%-83.7%) was slightly lower than expected.,"[{'ForeName': 'Stacy M', 'Initials': 'SM', 'LastName': 'Lenger', 'Affiliation': ''}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Chu', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington University School of Medicine.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ghetti', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington University School of Medicine.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Durkin', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Jennings', 'Affiliation': 'Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University School of Medicine.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Sutcliffe', 'Affiliation': ''}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Lowder', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington University School of Medicine.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000001171']
787,35422183,Glyphosate at low doses changes the physiology and increases the productivity of common bean as affected by sowing seasons.,"Glyphosate applied at low doses can stimulate photosynthesis and yield. The objective of this study was to evaluate the application of low doses of glyphosate and sowing seasons in physiological characteristics and grain yield of common bean of early cycle. Two experiments were conducted in the field, the first in winter season and the second in wet season. The experimental design was a randomized complete block design, consisting of five and seven low doses of glyphosate and one period of application, with four replications. Glyphosate low dose of 108.0 g a.e. ha -1  impaired net CO 2  assimilation rate, stomatal conductance, transpiration rate, instantaneous carboxylation efficiency, number of pods per plant, number of grains per plant and number of grains per pod. Glyphosate dose of 7.2 g a.e. ha -1  provided a 23% increase in grain yield in winter season, and the dose of 36.0 g a.e. ha -1  provided a 109% increase in grain yield in wet season. To our knowledge, this is the first report on effect of glyphosate at low doses and sowing season to obtain yield increases in common bean of early cycle.",2022,"ha -1  impaired net CO 2  assimilation rate, stomatal conductance, transpiration rate, instantaneous carboxylation efficiency, number of pods per plant, number of grains per plant and number of grains per pod.",[],[],"['ha -1  impaired net CO 2  assimilation rate, stomatal conductance, transpiration rate, instantaneous carboxylation efficiency, number of pods per plant, number of grains per plant and number of grains per pod', 'grain yield']",[],[],"[{'cui': 'C0671334', 'cui_str': 'mHag HA-1'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C1704301', 'cui_str': 'Assimilation, Cultural'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}]",,0.0545929,"ha -1  impaired net CO 2  assimilation rate, stomatal conductance, transpiration rate, instantaneous carboxylation efficiency, number of pods per plant, number of grains per plant and number of grains per pod.","[{'ForeName': 'Fernanda Pacheco de Almeida Prado', 'Initials': 'FPAP', 'LastName': 'Bortolheiro', 'Affiliation': 'Laboratory of Ecophysiology Applied to Agriculture, School of Agricultural Sciences, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Marcela Cristina', 'Initials': 'MC', 'LastName': 'Brunelli-Nascentes', 'Affiliation': 'Laboratory of Ecophysiology Applied to Agriculture, School of Agricultural Sciences, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Renan Fonseca', 'Initials': 'RF', 'LastName': 'Nascentes', 'Affiliation': 'Laboratory of Weed Science, School of Agricultural Sciences, São Paulo State University (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Marcelo de Almeida', 'Initials': 'MA', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Ecophysiology Applied to Agriculture, School of Agricultural Sciences, São Paulo State University (UNESP), Botucatu, Brazil.'}]","Journal of environmental science and health. Part. B, Pesticides, food contaminants, and agricultural wastes",['10.1080/03601234.2022.2064669']
788,35428577,"DIAGNOdent pen quantification of the synergy of NovaMin® in fluoride toothpaste to remineralize white spot lesions in patients with fixed orthodontic appliances: A double-blind, randomized, controlled clinical trial.","OBJECTIVES


White spot lesions (WSLs) are a real problem in patients with fixed orthodontic appliances with inadequate hygiene and eating habits. This study aimed at evaluating the synergic effects of NovaMin in fluoride toothpaste on remineralization of WSLs in patients with fixed orthodontic appliances.
METHODS


In the present double-blind, randomized, controlled, parallel, clinical trial, Patients with a minimum of 1 WSL on the buccal surface of the anterior teeth and the first premolar on both arches were recruited between 12 February 2021 and 12 April 2021 at the Faculty of Dentistry of X. They were randomly divided into 2 groups, the control group receiving fluoride toothpaste (Sensodyne® Rapid Relief, England), and the study group receiving the fluoride-containing toothpaste and NovaMin (Sensodyne® Repair and Protect, England). A DIAGNOdent pen (KAVO Dental Corporation, Germany) was used to score the WSLs at baseline and then after the usage for 1 and 3months. The primary outcome measures were the difference in DIAGNOdent score in patients with fixed orthodontic appliances that used fluoride toothpaste and NovaMin/fluoride toothpaste. The secondary outcome measures were the intragroup comparison of the DIAGNOdent score in patients with fixed orthodontic appliances that used fluoride toothpaste and NovaMin/fluoride toothpaste. The type of toothpaste used was blinded for the participants, examiner, and data analyser.
RESULTS


A sample size comprising 38 patients (19 patients in each group) was determined. In each group, statistical analysis was conducted on 18 patients. A patient in each group refused to contribute to the study. In both groups (P<0.001), the DIAGNOdent reading of the WSLs decreased significantly after 1 and at 3months, though no significant difference was found between the two groups at different intervals. Each patient had no adverse effects.
CONCLUSIONS


In this 3-month follow-up study, NovaMin/fluoride toothpaste provided a slight improvement in WSL remineralisation, but not significant compared to fluoride toothpaste. NovaMin therefore did not have a significant synergistic effect. Both types of toothpaste can improve WSLs in orthodontic patients.
THE CLINICAL TRIAL REGISTRATION NUMBER


IRCT20140215016582N5.",2022,"In both groups (P<0.001), the DIAGNOdent reading of the WSLs decreased significantly after 1 and at 3months, though no significant difference was found between the two groups at different intervals.","['orthodontic patients', 'patients with fixed orthodontic appliances with inadequate hygiene and eating habits', 'Patients with a minimum of 1 WSL on the buccal surface of the anterior teeth and the first premolar on both arches were recruited between 12 February 2021 and 12 April 2021 at the Faculty of Dentistry of X', 'patients with fixed orthodontic appliances']","['NovaMin', 'NovaMin/fluoride toothpaste', 'fluoride toothpaste', 'fluoride toothpaste and NovaMin/fluoride toothpaste', 'toothpaste', 'control group receiving fluoride toothpaste (Sensodyne® Rapid Relief, England', 'fluoride-containing toothpaste and NovaMin (Sensodyne® Repair and Protect, England']","['DIAGNOdent reading of the WSLs', 'remineralization of WSLs', 'WSL remineralisation']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}]","[{'cui': 'C1722474', 'cui_str': 'NovaMin'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0385317', 'cui_str': 'Sensodyne'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",38.0,0.191282,"In both groups (P<0.001), the DIAGNOdent reading of the WSLs decreased significantly after 1 and at 3months, though no significant difference was found between the two groups at different intervals.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mollabashi', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Heydarpour', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: maryamheydarpour97@gmail.com.'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Farhadifard', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Alafchi', 'Affiliation': 'Department of Biostatistics, School of Public health and research centre for health sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",International orthodontics,['10.1016/j.ortho.2022.100632']
789,35428508,"Reply to Benjamin Davies, Keith Kowalczyk RE: Zachary Klaassen, Emily Vertosick, Andrew J. Vickers, et al. Optimal Dissemination of Scientific Manuscripts via Social Media: A Prospective Trial Comparing Visual Abstracts Versus Key Figures in Consecutive Original Manuscripts. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2022.01.041.",,2022,,['Scientific Manuscripts via Social Media'],[],[],"[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]",[],[],,0.0339047,,"[{'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Klaassen', 'Affiliation': 'Division of Urology, Medical College of Georgia, Augusta University, Augusta, GA, USA. Electronic address: zklaassen19@gmail.com.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Vickers', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Department of Urology, University of California-San Francisco Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutikov', 'Affiliation': 'Division of Urologic Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}]",European urology,['10.1016/j.eururo.2022.04.001']
790,35428507,"Re: Zachary Klaassen, Emily Vertosick, Andrew J. Vickers, et al. Optimal Dissemination of Scientific Manuscripts via Social Media: A Prospective Trial Comparing Visual Abstracts Versus Key Figures in Consecutive Original Manuscripts. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2022.01.041.",,2022,,['Scientific Manuscripts via Social Media'],[],[],"[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]",[],[],,0.0291721,,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Davies', 'Affiliation': 'Department of Urology, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: daviesbj@upmc.edu.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Kowalczyk', 'Affiliation': 'Department of Urology, MedStar Georgetown University Hospital, Washington, DC, USA.'}]",European urology,['10.1016/j.eururo.2022.03.034']
791,35428889,Spine Volumetric BMD and Strength in Premenopausal Idiopathic Osteoporosis: Effect of Teriparatide Followed by Denosumab.,"CONTEXT


Premenopausal women with idiopathic osteoporosis (PreMenIOP) have marked deficits in bone density, microstructure, and strength.
OBJECTIVE


To define effects of treatment with teriparatide followed by denosumab on lumbar spine (LS) volumetric bone mineral density (vBMD) and stiffness by finite element analysis assessed on central quantitative computed tomography (cQCT) scans.
DESIGN, SETTINGS, AND PARTICIPANTS


Ancillary analysis of baseline, post-teriparatide, and post-denosumab cQCT scans from a randomized trial of 41 women allocated to teriparatide (20 mcg daily; n = 28) or placebo (n = 11). After 6 months, those on teriparatide continued for 18 months, and those on placebo switched to teriparatide for 24 months. After completing teriparatide, 33 enrolled in a Phase 2B extension with denosumab (60 mg every 6 months) for 12 months.
MAIN OUTCOME MEASURES


Primary outcomes were percentage change from baseline in LS trabecular vBMD and stiffness after teriparatide and between end of teriparatide and completing denosumab. Percentage change from baseline in LS trabecular vBMD and stiffness after sequential teriparatide and denosumab were secondary outcomes.
FINDINGS


There were large increases (all Ps < 0.001) in trabecular vBMD (25%), other vBMD parameters, and stiffness (21%) after teriparatide. Statistically significant increases in trabecular vBMD (10%; P < 0.001) and other vBMD parameters (P = 0.03-0.001) were seen after denosumab, while stiffness increased by 7% (P = 0.068). Sequential teriparatide and denosumab led to highly significant (all Ps < 0.001) increases LS trabecular vBMD (43%), other vBMD parameters (15-31%), and stiffness (21%).
CONCLUSIONS


The large and statistically significant increases in volumetric density and stiffness after sequential treatment with teriparatide followed by denosumab are encouraging and support use of this regimen in PreMenIOP.",2022,"Statistically significant increases in trabecular vBMD (10%; p<0.001) and other vBMD parameters (p=0.03-0.001) were seen after denosumab, while stiffness increased by 7% (p=0.068).","['Premenopausal women with idiopathic osteoporosis (PreMenIOP', '41 women allocated to', 'premenopausal idiopathic osteoporosis']","['teriparatide', 'Sequential teriparatide and denosumab', 'teriparatide and post-denosumab cQCT scans', 'denosumab', 'placebo']","['Spine volumetric BMD and strength', 'LS trabecular vBMD and stiffness', 'Lumbar Spine (LS) volumetric BMD (vBMD', 'volumetric density and stiffness', 'LS trabecular vBMD', 'trabecular vBMD', 'vBMD parameters']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0158447', 'cui_str': 'Idiopathic osteoporosis'}, {'cui': 'C4543879', 'cui_str': 'Premenopausal idiopathic osteoporosis'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",41.0,0.156668,"Statistically significant increases in trabecular vBMD (10%; p<0.001) and other vBMD parameters (p=0.03-0.001) were seen after denosumab, while stiffness increased by 7% (p=0.068).","[{'ForeName': 'Sanchita', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shane', 'Affiliation': 'Department of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lang', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Shiau', 'Affiliation': 'Department of Biostatistics & Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.'}, {'ForeName': 'Mafo', 'Initials': 'M', 'LastName': 'Kamanda-Kosseh', 'Affiliation': 'Department of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Bucovsky', 'Affiliation': 'Department of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Lappe', 'Affiliation': 'Department of Medicine, Creighton University Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Stubby', 'Affiliation': 'Department of Medicine, Creighton University Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Recker', 'Affiliation': 'Department of Medicine, Creighton University Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Yizhong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Bone Bioengineering Laboratory, Department of Biomedical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Zexi', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Bone Bioengineering Laboratory, Department of Biomedical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Edward Guo', 'Affiliation': 'Bone Bioengineering Laboratory, Department of Biomedical Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac232']
792,35428884,Safety and Efficacy of Lonapegsomatropin in Children With Growth Hormone Deficiency: enliGHten Trial 2-Year Results.,"PURPOSE


The objectives of the ongoing, Phase 3, open-label extension trial enliGHten are to assess the long-term safety and efficacy of weekly administered long-acting growth hormone lonapegsomatropin in children with growth hormone deficiency.
METHODS


Eligible subjects completing a prior Phase 3 lonapegsomatropin parent trial (heiGHt or fliGHt) were invited to participate. All subjects were treated with lonapegsomatropin. Subjects in the United States switched to the TransCon hGH Auto-Injector when available. Endpoints were long-term safety, annualized height velocity, pharmacodynamics [insulin-like growth factor-1 SD score (SDS) values], and patient- and caregiver-reported assessments of convenience and tolerability.
RESULTS


Lonapegsomatropin treatment during enliGHten was associated with continued improvements in height SDS through week 104 in treatment-naïve subjects from the heiGHt trial (-2.89 to -1.37 for the lonapegsomatropin group; -3.0 to -1.52 for the daily somatropin group). Height SDS also continued to improve among switch subjects from the fliGHt trial (-1.42 at fliGHt baseline to -0.69 at week 78). After 104 weeks, the average bone age/chronological age ratio for each treatment group was 0.8 (0.1), showing only minimal advancement of bone age relative to chronological age with continued lonapegsomatropin treatment among heiGHt subjects. Fewer local tolerability reactions were reported with the TransCon hGH Auto-Injector compared with syringe/needle.
CONCLUSIONS


Treatment with lonapegsomatropin continued to be safe and well-tolerated, with no new safety signals identified. Children treated with once-weekly lonapegsomatropin showed continued improvement of height SDS through the second year of therapy without excess advancement of bone age.",2022,Lonapegsomatropin treatment during enliGHten was associated with continued improvements in height SDS through Week 104 in treatment-naïve subjects from the heiGHt trial (-2.89 to -1.37 for- the lonapegsomatropin group; -3.0 to -1.52 for the daily somatropin group).,"['Eligible subjects completing a prior Phase 3 lonapegsomatropin parent trial (heiGHt or fliGHt) were invited to participate', 'children with growth hormone deficiency (GHD', 'Children with Growth Hormone Deficiency']","['long-acting growth hormone (LAGH) lonapegsomatropin', 'Lonapegsomatropin', 'lonapegsomatropin']","['Safety and Efficacy', 'safe and well-tolerated', 'height SDS', 'long-term safety, annualized height velocity (AHV), pharmacodynamics (insulin-like growth factor-1 standard deviation score [IGF-1 SDS] values), and patient- and caregiver-reported assessments of convenience and tolerability', 'local tolerability reactions', 'Height SDS']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0612478,Lonapegsomatropin treatment during enliGHten was associated with continued improvements in height SDS through Week 104 in treatment-naïve subjects from the heiGHt trial (-2.89 to -1.37 for- the lonapegsomatropin group; -3.0 to -1.52 for the daily somatropin group).,"[{'ForeName': 'Aristides K', 'Initials': 'AK', 'LastName': 'Maniatis', 'Affiliation': 'Rocky Mountain Pediatric Endocrinology, Centennial, CO, USA.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Casella', 'Affiliation': ""Children's Hospital at Dartmouth-Hitchcock, LebanonNH, USA.""}, {'ForeName': 'Ulhas M', 'Initials': 'UM', 'LastName': 'Nadgir', 'Affiliation': 'Center of Excellence in Diabetes and Endocrinology, Sacramento, CA, USA.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Saenger', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Elena D', 'Initials': 'ED', 'LastName': 'Chertock', 'Affiliation': 'Voronezh State Medical University, Voronezh, Russia.'}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Aghajanova', 'Affiliation': 'Yerevan State Medical University, Yerevan, Armenia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Korpal-Szczyrska', 'Affiliation': 'Klinika Pediatrii, Diabetologii i Endokrynologii Uniwersyteckie Centrum Kliniczne, Gdansk, Poland.'}, {'ForeName': 'Elpis', 'Initials': 'E', 'LastName': 'Vlachopapadopoulou', 'Affiliation': ""Children's Hospital. P. A. Kyriakou, Athens, Greece.""}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Malievskiy', 'Affiliation': 'Bashkir State Medical University, Ufa, Russia.'}, {'ForeName': 'Tetyana', 'Initials': 'T', 'LastName': 'Chaychenko', 'Affiliation': 'MHI Regional Child Clinical Hospital, Child Endocrinology Center, Kharkiv National Medical University, Kharkiv, Ukraine.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cappa', 'Affiliation': 'UOC di Endocrinologia, Ospedale Pediatrico Bambino Gesù, IRCCS, Rome, Italy.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Ascendis Pharma, Palo Alto, CA, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': 'Ascendis Pharma, Palo Alto, CA, USA.'}, {'ForeName': 'Per Holse', 'Initials': 'PH', 'LastName': 'Mygind', 'Affiliation': 'Ascendis Pharma, Palo Alto, CA, USA.'}, {'ForeName': 'Alden R', 'Initials': 'AR', 'LastName': 'Smith', 'Affiliation': 'Ascendis Pharma, Palo Alto, CA, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Chessler', 'Affiliation': 'Ascendis Pharma, Palo Alto, CA, USA.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Komirenko', 'Affiliation': 'Ascendis Pharma, Palo Alto, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beckert', 'Affiliation': 'Ascendis Pharma A/S, Hellerup, Denmark.'}, {'ForeName': 'Aimee D', 'Initials': 'AD', 'LastName': 'Shu', 'Affiliation': 'Ascendis Pharma, Palo Alto, CA, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Thornton', 'Affiliation': ""Cook Children's Health Care System, Fort Worth, TX, USA.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac217']
793,35415804,A Brief Educational Intervention to Increase ED Initiation of Buprenorphine for Opioid Use Disorder (OUD).,"BACKGROUND


Despite the evidence in support of the use of buprenorphine in the treatment of OUD and increasing ability of emergency medicine (EM) clinicians to prescribe it, emergency department (ED)-initiated buprenorphine is uncommon. Many EM clinicians lack training on how to manage acute opioid withdrawal or initiate treatment with buprenorphine. We developed a brief buprenorphine training program and assessed the impact of the training on subsequent buprenorphine initiation and knowledge retention.
METHODS


We conducted a pilot randomized control trial enrolling EM clinicians to receive either a 30-min didactic intervention about buprenorphine (standard arm) or the didactic plus weekly messaging and a monetary inducement to administer and report buprenorphine use (enhanced arm). All participants were incentivized to complete baseline, immediate post-didactic, and 90-day knowledge and attitude assessment surveys. Our objective was to achieve first time ED buprenorphine prescribing events in clinicians who had not previously prescribed buprenorphine in the ED and to improve EM-clinician knowledge and perceptions about ED-initiated buprenorphine. We also assessed whether the incentives and reminder messaging in the enhanced arm led to more clinicians administering buprenorphine than those in the standard arm following the training; we measured changes in knowledge of and attitudes toward ED-initiated buprenorphine.
RESULTS


Of 104 EM clinicians enrolled, 51 were randomized to the standard arm and 53 to the enhanced arm. Clinical knowledge about buprenorphine improved for all clinicians immediately after the didactic intervention (difference 19.4%, 95% CI 14.4% to 24.5%). In the 90 days following the intervention, one-third (33%) of all participants reported administering buprenorphine for the first time. Clinicians administered buprenorphine more frequently in the enhanced arm compared to the standard arm (40% vs. 26.3%, p = 0.319), but the difference was not statistically significant. The post-session knowledge improvement was not sustained at 90 days in the enhanced (difference 9.6%, 95% CI - 0.37% to 19.5%) or in the standard arm (difference 3.7%, 95% CI - 5.8% to 13.2%). All the participants reported an increased ability to recognize patients with opioid withdrawal at 90 days (enhanced arm difference .55, 95% CI .01-1.09, standard arm difference .85 95% CI .34-1.37).
CONCLUSIONS


A brief educational intervention targeting EM clinicians can be utilized to achieve first-time prescribing and improve knowledge around buprenorphine and opioid withdrawal. The use of weekly messaging and gain-framed incentivization conferred no additional benefit to the educational intervention alone. In order to further expand evidence-based ED treatment of OUD, focused initiatives that improve clinician competence with buprenorphine should be explored.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03821103.",2022,"Clinical knowledge about buprenorphine improved for all clinicians immediately after the didactic intervention (difference 19.4%, 95% CI 14.4% to 24.5%).","['Of 104 EM clinicians enrolled, 51 were randomized to the standard arm and 53 to the enhanced arm']","['30-min didactic intervention about buprenorphine (standard arm) or the didactic plus weekly messaging and a monetary inducement to administer and report buprenorphine', 'buprenorphine', 'buprenorphine training program', 'Buprenorphine']",[],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0337785,"Clinical knowledge about buprenorphine improved for all clinicians immediately after the didactic intervention (difference 19.4%, 95% CI 14.4% to 24.5%).","[{'ForeName': 'Utsha G', 'Initials': 'UG', 'LastName': 'Khatri', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania, Philadelphia, PA, USA. Utsha.khatri@mountsinai.org.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Penn Medicine Center for Digital Health, Center for Health Care Innovation, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': ""D'Orazio"", 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Shofer', 'Affiliation': 'Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jeanmarie', 'Initials': 'J', 'LastName': 'Perrone', 'Affiliation': 'Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of medical toxicology : official journal of the American College of Medical Toxicology,['10.1007/s13181-022-00890-7']
794,35418274,Effects of a Short Video Physical Activity Program on Physical Fitness Among Physical Education Students.,"The Brain Break (BB) short video program is designed to improve physical activity (PA), motor skills, and fitness in children. In this study, we examined the effects of an 8-week short video-based Brain Break (HOPSports Company) PA program within physical education (PE) lessons on fitness and fitness knowledge among students. We studied 62 fifth-grade students (experimental group = 28; control group = 34) in the Ankara, Turkey school district. The experimental group received PE lessons once per week for eight weeks with the BB PA program, with extra videos viewed at home three days per week, while the control group received routine PE lessons during this period. We collected student responses to the Fitness Knowledge Test for Children and the Fitnessgram Test Battery before and after the experimental BB program. Results revealed that the experimental group showed increased fitness and fitness knowledge compared to the control group, showing that the BB PA videos can increase fitness and fitness knowledge in students.",2022,"Results revealed that the experimental group showed increased fitness and fitness knowledge compared to the control group, showing that the BB PA videos can increase fitness and fitness knowledge in students.","['students', '62 fifth-grade students (experimental group = 28; control group = 34) in the Ankara, Turkey school district', 'Physical Education Students']","['routine PE lessons', 'BB PA videos', '8-week short video-based Brain Break (HOPSports Company) PA program within physical education (PE) lessons', 'Short Video Physical Activity Program', 'PE lessons']","['fitness and fitness knowledge', 'Physical Fitness', 'physical activity (PA), motor skills, and fitness in children']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",62.0,0.0063361,"Results revealed that the experimental group showed increased fitness and fitness knowledge compared to the control group, showing that the BB PA videos can increase fitness and fitness knowledge in students.","[{'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Bulca', 'Affiliation': 'Department of Physical Education and Sports Teaching, Faculty of Sport Science, 37515Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Bilgin', 'Affiliation': 'Department of Physical Education and Sports Teaching, Faculty of Sport Science, 37515Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Altay', 'Affiliation': 'Department of Physical Education and Sports Teaching, Faculty of Sport Science, 37515Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Gıyasettin', 'Initials': 'G', 'LastName': 'Demirhan', 'Affiliation': 'Department of Physical Education and Sports Teaching, Faculty of Sport Science, 37515Hacettepe University, Ankara, Turkey.'}]",Perceptual and motor skills,['10.1177/00315125221088069']
795,35419831,"Comparison of concurrent chemoradiotherapy with radiotherapy alone for locally advanced esophageal squamous cell cancer in elderly patients: A randomized, multicenter, phase II clinical trial.","This randomized, multicenter, phase II clinical trial was performed to compare the safety and efficacy of concurrent chemoradiotherapy using S-1 (CCRT) with radiotherapy alone (RT) for elderly patients with locally advanced esophageal squamous cell carcinoma (ESCC). All eligible patients were randomly assigned to the CCRT group or the RT group at a 1:1 ratio. The CCRT group received 50.4 Gy radiotherapy concurrent with S-1 and the RT group received 59.4 Gy radiotherapy alone. The primary endpoints were toxicity and the overall response rate (ORR), and the secondary endpoints were overall survival (OS) and progression-free survival (PFS). In total, 157 elderly patients with ESCC were recruited from December 2016 to March 2020. By June 2021, the median follow-up duration had reached 38 months. No grade 5 toxicities occurred in either group and the overall rate of severe toxicities (≥grade 3) was higher in the CCRT group (19.2% vs 7.6%; P = .037), particularly neutropenia (7.7% vs 1.3%; P = .06). The CCRT group presented a significantly higher ORR (83.3% vs 68.4%; P = .009) and prolonged PFS (25.7 vs 13.9 months; P = .026) than the RT group. The median OS was 27.3 months in the CCRT group and 19.1 months in the RT group (P = .59). For patients older than 70 years with locally advanced ESCC, concurrent chemoradiotherapy with S-1 had tolerable adverse effects and improved ORR and PFS compared to radiotherapy alone.",2022,The CCRT group presented a significantly higher ORR (83.3% vs. 68.4%; p=0.009) and prolonged PFS (25.7 months vs.13.9 months; p=0.026) than the RT group.,"['157 elderly patients with ESCC were recruited from December 2016 to March 2020', 'elderly patients with locally advanced esophageal squamous cell carcinoma (ESCC', 'Locally Advanced Esophageal Squamous Cell Cancer in Elderly Patients', 'patients older than 70\u2009years with locally advanced ESCC']","['radiotherapy', 'concurrent chemoradiotherapy using S-1 (CCRT) with radiotherapy alone (RT', 'CCRT', 'Concurrent Chemoradiotherapy with Radiotherapy Alone', 'Gy radiotherapy']","['grade 5 toxicities', 'tolerable adverse effects and improved ORR and PFS', 'overall rate of severe toxicities', 'median OS', 'toxicity and the overall response rate (ORR', 'prolonged PFS', 'safety and efficacy', 'particularly neutropenia', 'overall survival (OS) and progression-free survival (PFS', 'ORR']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}]","[{'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",157.0,0.0381636,The CCRT group presented a significantly higher ORR (83.3% vs. 68.4%; p=0.009) and prolonged PFS (25.7 months vs.13.9 months; p=0.026) than the RT group.,"[{'ForeName': 'Yanxiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Graduate, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Radiation Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of Science and Technology, Anyang, China.'}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Yaowen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of Science and Technology, Anyang, China.'}, {'ForeName': 'Fujun', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of Science and Technology, Anyang, China.'}, {'ForeName': 'Heyi', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Haiqun', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Oncology, Taian City Central Hospital, Taian, Shandong, China.'}, {'ForeName': 'Zhiqiao', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Tumor Diagnosis and Treatment Center, Kaifeng Central Hospital, Kaifeng, Henan, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Shanxi Cancer Hospital, Taiyuan, Shanxi, China.'}, {'ForeName': 'Wenzhi', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Oncology, Taian City Central Hospital, Taian, Shandong, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Radiation Therapy Department, 1 Ward of the First Affiliated Hospital of Xinxiang, Weihui, Henan, China.'}, {'ForeName': 'Anping', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': 'Department of Radiation Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of Science and Technology, Anyang, China.'}, {'ForeName': 'Baosheng', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}]",International journal of cancer,['10.1002/ijc.34030']
796,35419807,Muscarinic-3-receptor positive allosteric modulator ASP8302 in patients with underactive bladder. A randomized controlled trial.,"AIM


The aim of this study is to evaluate safety and efficacy of ASP8302, a novel positive allosteric modulator for the muscarinic M3 receptor (M3-PAM), in patients with underactive bladder (UAB).
METHODS


A randomized, double-blind, placebo-controlled multicenter study was performed in adult male/female subjects with UAB, defined as incomplete bladder emptying (postvoid residual volume [PVR] > 100 ml) without significant bladder outlet obstruction and/or overactive bladder. Subjects were randomized (1:1) to receive 4-week oral once-daily administration of 100 mg ASP8302 or matching placebo. Primary endpoint was a change from baseline in PVR measured by catheterization after standardized bladder filling (PVR C2  ). Other endpoints included PVR and bladder voiding efficiency (BVE) measured in various ways, uroflowmetry, bladder diary, and questionnaires. Pressure-flow studies were performed in a subgroup.
RESULTS


One hundred and thirty-five patients were randomized (ASP8302 group: 65 patients, placebo group: 70 patients). The median change in PVR C2  was -40.0 ml (ASP8302) versus -35.0 ml (placebo) and the difference between groups was -5.0 ml (p = 0.960). In males, functional and symptomatic outcomes improved, for example, maximum urine flow rate (Q max  ) and detrusor pressure at Q max  (P det.Qmax  ) increased (mean difference in change ASP8302 vs. placebo: 3.8 ml/s, p = 0.031 and 12.7 cm H 2  O, p = 0.034, respectively). Urinary incontinence episodes/24 h decreased in males with preexisting incontinence (mean difference: -0.35; p = 0.028). The incidence of adverse events was similar between study groups (ASP8302: 33.3%, placebo: 31.4%). In the included subjects, both baseline urine flow and bladder voiding pressure was low. Compared with PVR, simultaneous BVE measurements were more consistent between various methods (spontaneous vs. standardized bladder filling, catheterization vs. ultrasound [US]).
CONCLUSIONS


ASP8302 was safe and well tolerated in patients with UAB identified by nonurodynamic clinical criteria, but it did not show efficacy in the primary endpoint. However, in males it showed improvement of symptoms and functional parameters. BVE (using US) is a more optimal outcome measure than PVR in UAB.",2022,"The incidence of adverse events was similar between study groups (ASP8302: 33.3%, placebo: 31.4%).","['patients with underactive bladder', 'adult male/female subjects with UAB, defined as incomplete bladder emptying (postvoid residual volume [PVR]\u2009>\u2009100\u2009ml) without significant bladder outlet obstruction and/or overactive bladder', 'males with preexisting incontinence (mean difference', 'Urinary incontinence episodes/24', 'patients with UAB identified by nonurodynamic clinical criteria', 'patients with underactive bladder (UAB', '65 patients, placebo group: 70 patients', 'One hundred and thirty-five patients were randomized (ASP8302 group']","['ASP8302 or matching placebo', 'ASP8302) versus -35.0\u2009ml (placebo', 'Muscarinic-3-receptor positive allosteric modulator ASP8302', 'ASP8302', 'BVE', 'placebo']","['safe and well tolerated', 'incidence of adverse events', 'change from baseline in PVR measured by catheterization after standardized bladder filling (PVR C2  ', 'median change in PVR C2', 'maximum urine flow rate (Q max  ) and detrusor pressure at Q max', 'PVR and bladder voiding efficiency (BVE) measured in various ways, uroflowmetry, bladder diary, and questionnaires', 'baseline urine flow and bladder voiding pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4704753', 'cui_str': 'Underactive Urinary Bladder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0344365', 'cui_str': 'Incomplete emptying of bladder'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0005694', 'cui_str': 'Bladder neck obstruction'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026815', 'cui_str': 'Muscarinics'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0429766', 'cui_str': 'Detrusor pressure'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",135.0,0.456458,"The incidence of adverse events was similar between study groups (ASP8302: 33.3%, placebo: 31.4%).","[{'ForeName': 'Jan Willem Olivier', 'Initials': 'JWO', 'LastName': 'van Till', 'Affiliation': 'Medical and Development, Astellas Pharma Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Arita', 'Affiliation': 'Medical and Development, Astellas Pharma Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kuroishi', 'Affiliation': 'Medical and Development, Astellas Pharma Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Croy', 'Affiliation': 'Medical and Development, Astellas Pharma Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Oelke', 'Affiliation': 'Department of Urology, Paediatric Urology and Uro-Oncology, St. Antonius Hospital, Gronau, Germany.'}, {'ForeName': 'Gommert A', 'Initials': 'GA', 'LastName': 'van Koeveringe', 'Affiliation': 'Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Chapple', 'Affiliation': 'Department of Urology, The Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Urology, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}]",Neurourology and urodynamics,['10.1002/nau.24931']
797,35427495,Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy in the treatment of perianal fistulas in Crohn's disease (PISA-II): a patient preference randomised trial.,"BACKGROUND


Guidelines on Crohn's perianal fistulas recommend anti-tumour necrosis factor (TNF) treatment and suggest considering surgical closure for patients with surgically amenable disease. However, long-term outcomes following these two strategies have not been directly compared. The aim of this study was to assess radiological healing in patients who received short-term anti-TNF treatment and surgical closure compared with those who received anti-TNF treatment alone.
METHODS


The PISA-II trial was a multicentre, patient preference study done in nine hospitals in the Netherlands and one hospital in Italy. Adult patients with Crohn's disease and an active high perianal fistula with a single internal opening were eligible for inclusion. After counselling, patients with no treatment preference were randomly assigned (1:1) using random block randomisation (block sizes of six without statification), to 4-month anti-TNF therapy and surgical closure or anti-TNF therapy for 1 year, after seton insertion. Patients with a treatment preference received their preferred therapy. The primary outcome was radiological healing assessed by MRI at 18 months, defined as a complete fibrotic tract or a MAGNIFI-CD (Magnetic Resonance Index for Fistula Imaging in Crohn's Disease) score of 0, assessed according to the intention-to-treat principle. Secondary outcomes included clinical closure, number of patients undergoing surgical reintervention and number of reinterventions, recurrences, and impact on quality of life measured by the Perianal Disease Activity Index (PDAI). Analyses were performed on an intention-to-treat basis and additionally an as-treated analysis for radiological healing and clinical closure. This study was registered at the Dutch Trial Registry, NL7625, and with EudraCT, 2018-002064-15, and is closed to accrual due to completion.
FINDINGS


Between Sept 14, 2013, and Dec 7, 2019, 94 patients were enrolled onto the trial, of whom 32 (34%) were randomly assigned and 62 (66%) chose a specific treatment. 38 (40%) patients were assigned to the surgical closure group and 56 (60%) patients to the anti-TNF group. At 18 months, radiological healing was significantly more common in the surgical closure group (12 [32%] patients) than in the anti-TNF group (five [9%] patients; p=0·005). By contrast, clinical closure was not significantly different between the two treatment groups (26 [68%] patients in the surgical closure group vs 29 [52%] patients in the anti-TNF group; p=0·076). Significantly fewer patients required a reintervention in the surgical closure group than in the anti-TNF therapy group (five [13%] patients in the surgical closure group, median one reintervention [IQR one to three] vs 24 [43%] patients in the anti-TNF group, median two reinterventions [one to two]; p=0·005). Among patients who reached clinical closure during follow-up, four (14%) of 29 in the surgical closure group and five (16%) of 31 in the anti-TNF therapy group had a recurrence, which occurred only in patients without radiological healing. PDAI was significantly lower in the surgical closure group than in the anti-TNF group after 18 months (p=0·031). Adverse events and serious adverse events were similar in both treatment groups and mostly entailed reinterventions. Ten (11%) patients had side-effects associated with anti-TNF treatment. Two serious adverse events unrelated to study treatment occurred (appendicitis and myocardial infarction). One patient died from a tongue base carcinoma, unrelated to study treatment.
INTERPRETATION


Short-term anti-TNF treatment combined with surgical closure induces long-term MRI healing more frequently than anti-TNF therapy in patients with Crohn's perianal fistulas. These data suggest that patients with Crohn's perianal fistula amenable for surgical closure should be counselled for this therapeutic approach.
FUNDING


Netherlands Organisation for Health Research and Development and Broad Medical Research Program.",2022,"At 18 months, radiological healing was significantly more common in the surgical closure group (12 [32%] patients) than in the anti-TNF group (five [9%] patients; p=0·005).","['nine hospitals in the Netherlands and one hospital in Italy', 'patients who received', 'patients with no treatment preference', 'patients with surgically amenable disease', 'Between Sept 14, 2013, and Dec 7, 2019, 94 patients were enrolled onto the trial, of whom 32 (34', ""patients with Crohn's perianal fistula"", ""perianal fistulas in Crohn's disease (PISA-II"", ""Adult patients with Crohn's disease and an active high perianal fistula with a single internal opening were eligible for inclusion"", ""patients with Crohn's perianal fistulas""]","['short-term anti-TNF treatment and surgical closure compared with those who received anti-TNF treatment alone', 'Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy', 'random block randomisation (block sizes of six without statification), to 4-month anti-TNF therapy and surgical closure or anti-TNF therapy', 'anti-TNF therapy']","['Adverse events and serious adverse events', 'PDAI', 'clinical closure, number of patients undergoing surgical reintervention and number of reinterventions, recurrences, and impact on quality of life measured by the Perianal Disease Activity Index (PDAI', ""radiological healing assessed by MRI at 18 months, defined as a complete fibrotic tract or a MAGNIFI-CD (Magnetic Resonance Index for Fistula Imaging in Crohn's Disease) score of 0, assessed according to the intention-to-treat principle"", 'radiological healing', 'clinical closure', 'median one reintervention [IQR']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0267561', 'cui_str': 'Perianal fistula'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185003', 'cui_str': 'Closure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442158', 'cui_str': 'Perianal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",94.0,0.0319804,"At 18 months, radiological healing was significantly more common in the surgical closure group (12 [32%] patients) than in the anti-TNF group (five [9%] patients; p=0·005).","[{'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Meima-van Praag', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Kyra L', 'Initials': 'KL', 'LastName': 'van Rijn', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Karin A T G M', 'Initials': 'KATGM', 'LastName': 'Wasmann', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harmanna J', 'Initials': 'HJ', 'LastName': 'Snijder', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Stoker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Krisztina B', 'Initials': 'KB', 'LastName': 'Gecse', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Gerhards', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Jansen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jarmila D W', 'Initials': 'JDW', 'LastName': 'van der Bilt', 'Affiliation': 'Department of Surgery, Flevoziekenhuis, Almere, Netherlands.'}, {'ForeName': 'Marco W', 'Initials': 'MW', 'LastName': 'Mundt', 'Affiliation': 'Department of Gastroenterology and Hepatology, Flevoziekenhuis, Almere, Netherlands.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Spinelli', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, IRCCS Humanitas Research Hospital, Milan, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands; Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Christianne J', 'Initials': 'CJ', 'LastName': 'Buskens', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands. Electronic address: c.j.buskens@amsterdamumc.nl.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(22)00088-7']
798,35429901,"Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.","BACKGROUND


An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis.
METHODS


Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death).
RESULTS


OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81-1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81-1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed.
CONCLUSIONS


Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.
TRIAL REGISTRATION


NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).",2022,"Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827).","['Postmenopausal patients (N\xa0=\xa0601', 'MBC patients progressing on aromatase inhibitors', 'postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study', '2013-003170-27 (EudraCT']","['palbociclib plus endocrine therapy versus capecitabine', 'capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant', 'capecitabine', 'palbociclib plus endocrine therapy (ET']","['Median PFS2', 'Overall survival', 'final overall survival (OS) analysis']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",601.0,0.24101,"Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827).","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martín', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain. Electronic address: mmartin@geicam.org.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zielinski', 'Affiliation': 'Vienna Cancer Center, Medical University Vienna and Vienna Hospital Association, Vienna, Austria; CECOG, Central European Cooperative Oncology Group, Vienna, Austria.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruiz-Borrego', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario Virgen Del Rocío, Sevilla, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Carrasco', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Ciruelos', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario 12 de Octubre, Madrid, Spain; HM Hospitales Madrid, Spain; SOLTI Group on Breast Cancer Research.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Translational Genomics and Targeted Therapies in Solid Tumours, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Bermejo', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain; Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria-INCLIVA Valencia, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Margelí', 'Affiliation': ""GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Badalona Applied Research Group in Oncology (ARGO Group), Institut Catalá D'Oncologia, Hospital Universitari Germans Trias I Pujol, Badalona, Spain.""}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csöszi', 'Affiliation': 'CECOG, Central European Cooperative Oncology Group, Vienna, Austria; Department of Oncology, Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelőintezet, Szolnok, Hungary.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Antón', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón-IISA, Zaragoza, Spain.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Institute of Cancer Research and Royal Marsden, London, UK.'}, {'ForeName': 'María I', 'Initials': 'MI', 'LastName': 'Casas', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Serafín', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Medical Oncology. Hospital Universitario Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Alba', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain; UGCI Medical Oncology, Hospitales Regional y Virgen de La Victoria. IBIMA. Málaga, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Calvo', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'de la Haba-Rodríguez', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain; Instituto Maimonides de Investigación Biomédica, Hospital Reina Sofía Hospital, Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro Oncológico de Galicia, A Coruña, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Murillo', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Clínico de Zaragoza Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Santaballa', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Alonso-Romero', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario Virgen de La Arrixaca-IMIB, Murcia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Sánchez-Rovira', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Oncology Unit, Universitary Hospital Jaén, Spain.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Corsaro', 'Affiliation': 'Pfizer Inc., Milan, Italy.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Pfizer Inc., San Diego, USA.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Thallinger', 'Affiliation': 'CECOG, Central European Cooperative Oncology Group, Vienna, Austria; Department of Oncology, Medical University of Vienna, Austria.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Kahan', 'Affiliation': 'CECOG, Central European Cooperative Oncology Group, Vienna, Austria; Department of Oncotherapy, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': ""GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Institut Català D'Oncologia (ICO) & IDIBELL, L'Hospitalet, Barcelona, Spain.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.03.006']
799,35436135,Percutaneous Transvalvular Microaxial Flow Pump Support in Cardiology.,"The Impella device (Impella, Abiomed, Danvers, MA) is a percutaneous transvalvular microaxial flow pump that is currently used for (1) cardiogenic shock, (2) left ventricular unloading (combination of venoarterial extracorporeal membrane oxygenation and Impella concept), (3) high-risk percutaneous coronary interventions, (4) ablation of ventricular tachycardia, and (5) treatment of right ventricular failure. Impella-assisted forward blood flow increased mean arterial pressure and cardiac output, peripheral tissue perfusion, and coronary blood flow in observational studies and some randomized trials. However, because of the need for large-bore femoral access (14 F for the commonly used Impella CP device) and anticoagulation, the incidences of bleeding and ischemic complications are as much as 44% and 18%, respectively. Hemolysis is reported in as many as 32% of patients and stroke in as many as 13%. Despite the rapidly growing use of the Impella device, there are still insufficient data on its effect on outcome and complications on the basis of large, adequately powered randomized controlled trials. The only 2 small and also underpowered randomized controlled trials in cardiogenic shock comparing Impella versus intra-aortic balloon pump did not show improved mortality. Several larger randomized controlled trials are currently recruiting patients or are in preparation in cardiogenic shock (DanGer Shock [Danish-German Cardiogenic Shock Trial; NCT01633502]), left ventricular unloading (DTU-STEMI [Door-To-Unload in ST-Segment-Elevation Myocardial Infarction; NCT03947619], UNLOAD ECMO [Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO], and REVERSE [A Prospective Randomised Trial of Early LV Venting Using Impella CP for Recovery in Patients With Cardiogenic Shock Managed With VA ECMO; NCT03431467]) and high-risk percutaneous coronary intervention (PROTECT IV [Impella-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function; NCT04763200]).",2022,"Impella-assisted forward blood flow increased mean arterial pressure and cardiac output, peripheral tissue perfusion, and coronary blood flow in observational studies and some randomized trials.","['Cardiogenic Shock Patients on VA-ECMO', 'Patients With Cardiogenic Shock']","['Impella-assisted forward blood flow', 'Early LV', 'intra-aortic balloon pump', 'high-risk percutaneous coronary intervention (PROTECT IV [Impella-Supported PCI']","['bleeding and ischemic complications', 'mortality', 'mean arterial pressure and cardiac output, peripheral tissue perfusion, and coronary blood flow']","[{'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0429877', 'cui_str': 'Tissue perfusion measure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.0760619,"Impella-assisted forward blood flow increased mean arterial pressure and cardiac output, peripheral tissue perfusion, and coronary blood flow in observational studies and some randomized trials.","[{'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Lüsebrink', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Kellnar', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Krieg', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Binzenhöfer', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Scherer', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zimmer', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Germany (S.Z.).'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schrage', 'Affiliation': 'Department of Cardiology, University Heart and Vascular Center Hamburg, and German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck (B.S.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Fichtner', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Petzold', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Braun', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Peterss', 'Affiliation': 'Herzchirurgische Klinik und Poliklinik (S.P., C.H.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Brunner', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hagl', 'Affiliation': 'Herzchirurgische Klinik und Poliklinik (S.P., C.H.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Westermann', 'Affiliation': 'Department of Cardiology and Angiology, University Heart Center Freiburg-Bad Krozingen, Faculty of Medicine, University of Freiburg, Freiburg, Germany (D.W.).'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hausleiter', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology and Leipzig Heart Institute, Germany (H.T.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schäfer', 'Affiliation': 'Klinik für Kardiologie und Angiologie, Medizinische Hochschule Hannover, Germany (A.S.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orban', 'Affiliation': 'Cardiac Intensive Care Unit, Medizinische Klinik und Poliklinik I (E.L., A.K., K.K., L.B., C.S., S.F., T.P., D.B., S.B., J.H., S.M., M.O.), Klinikum der Universität München, and German Center for Cardiovascular Research, partner site Munich Heart Alliance.'}]",Circulation,['10.1161/CIRCULATIONAHA.121.058229']
800,35436920,Effect of semi-recumbent vibration exercise on muscle outcomes in older adults: a pilot randomized controlled clinical trial.,"BACKGROUND


Many older adults with physical limitations living in residential care apartments are unable to exercise in a standing position and are at risk for declining in muscle function leading to falls and injury. Novel approaches to achieve exercise benefits are needed. The purpose of this study was to test the effect of semi-recumbent vibration exercise on muscle outcomes in older adults living in residential care apartment complexes (RCACs).
METHODS


A randomized, crossover design was used to examine the effect of semi-recumbent vibration exercise on muscle function and mass among 32 RCAC residents (mean age 87.5 years) with physical limitations. Participants received a randomized sequence of two study conditions: sham or vibration for 8 weeks each separated by a 4-week washout. Before and after the 8 weeks of vibration treatment and sham treatment, muscle mechanography was used to assess muscle function including jump power, weight-corrected jump power, and jump height. Short physical performance battery (SPPB) and handgrip strength were also used to measure muscle function. Bioelectrical impedance spectroscopy was used to estimate skeletal muscle mass. The effect of the vibration treatment on muscle outcomes was analyzed through mixed effects linear regression models.
RESULTS


Vibration exercise leads to better jump height (p < .05) compared to sham exercise but also poorer chair rise performance (p = 0.012). Other muscle functions tests and muscle mass parameters showed non-significant changes.
CONCLUSION


This small pilot study showed no conclusive results on the effect of semi-recumbent vibration exercise on muscle function and mass in older adults living in RCAC. However, the promising signals of improved jump performance could be used to power larger studies of longer duration with various vibration doses to determine the benefit of vibration exercise in this physically impaired, high-risk population with few exercise capabilities.
TRIAL REGISTRATION


The study is registered at clinicaltrials.gov ( NCT02533063 ; date of first registration 26/08/2015).",2022,"RESULTS


Vibration exercise leads to better jump height (p < .05) compared to sham exercise but also poorer chair rise performance (p = 0.012).","['older adults living in RCAC', '32 RCAC residents (mean age 87.5\xa0years) with physical limitations', 'older adults', 'older adults with physical limitations living in residential care apartments', 'older adults living in residential care apartment complexes (RCACs']","['semi-recumbent vibration exercise', 'vibration exercise', 'vibration treatment']","['Short physical performance battery (SPPB) and handgrip strength', 'jump height', 'poorer chair rise performance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0457933', 'cui_str': 'Apartment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0444334', 'cui_str': 'Recumbent body position'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",,0.0779266,"RESULTS


Vibration exercise leads to better jump height (p < .05) compared to sham exercise but also poorer chair rise performance (p = 0.012).","[{'ForeName': 'Murad H', 'Initials': 'MH', 'LastName': 'Taani', 'Affiliation': 'University of Wisocnsin Milwaukee, Wiscosin State, Milwaukee, USA. mhtaani@uwm.edu.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Binkley', 'Affiliation': 'University of Wisocnsin Madison, Wiscosin State, Madison, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'University of Wisocnsin Madison, Wiscosin State, Madison, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Krueger', 'Affiliation': 'University of Wisocnsin Madison, Wiscosin State, Madison, USA.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Buehring', 'Affiliation': 'University of Wisocnsin Madison, Wiscosin State, Madison, USA.'}]",BMC geriatrics,['10.1186/s12877-022-03052-0']
801,35438450,Early or late booster for basic life support skill for laypeople: a simulation-based randomized controlled trial.,"PURPOSE


Retention of skills and knowledge has been shown to be poor after resuscitation training. The effect of a ""booster"" is controversial and may depend on its timing. We compared the effectiveness of an early versus late booster session after Basic Life Support (BLS) training for skill retention at 4 months.
METHODS


We performed a single-blind randomized controlled trial in a simulation environment. Eligible participants were adult laypeople with no BLS training or practice in the 6 months prior to the study. We provided participants with formal BLS training followed by an immediate BLS skills post-test. We then randomized participants to one of three groups: control, early booster, or late booster. Based on their group allocation, participants attended a brief BLS refresher at either 3 weeks after training (early booster), at 2 months after training (late booster), or not at all (control). All participants underwent a BLS skills retention test at 4 months. We measured BLS skill performance according to the Heart and Stroke Foundation's skills testing checklist for adult CPR and the use of an automated external defibrillator.
RESULTS


A total of 80 laypeople were included in the analysis (control group, n = 28; early booster group, n = 23; late booster group, n = 29). The late booster group achieved better skill retention (mean difference in checklist score at retention compared to the immediate post-test = - 0.8 points out of 15, [95% CI - 1.7, 0.2], P = 0.10) compared to the early booster (- 1.3, [- 2.6, 0.0], P = 0.046) and control group (- 3.2, [- 4.7, - 1.8], P < 0.001).
CONCLUSION


A late booster session improves BLS skill retention at 4 months in laypeople.
TRIAL REGISTRATION NUMBER


NCT02998723.",2022,"The late booster group achieved better skill retention (mean difference in checklist score at retention compared to the immediate post-test = - 0.8 points out of 15, [95% CI - 1.7, 0.2], P = 0.10) compared to the early booster (- 1.3, [- 2.6, 0.0], P = 0.046) and control group (- 3.2, [- 4.7, - 1.8], P < 0.001).
","['A total of 80 laypeople were included in the analysis (control group, n\u2009=\u200928; early booster group, n\u2009=\u200923; late booster group, n\u2009=\u200929', 'laypeople', 'Eligible participants were adult laypeople with no BLS training or practice in the 6\xa0months prior to the study']",['Basic Life Support (BLS) training'],"['BLS skill performance', 'skill retention', 'BLS skill retention']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",80.0,0.108868,"The late booster group achieved better skill retention (mean difference in checklist score at retention compared to the immediate post-test = - 0.8 points out of 15, [95% CI - 1.7, 0.2], P = 0.10) compared to the early booster (- 1.3, [- 2.6, 0.0], P = 0.046) and control group (- 3.2, [- 4.7, - 1.8], P < 0.001).
","[{'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Boet', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8M2, Canada. sboet@toh.ca.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Waldolf', 'Affiliation': 'Department of Innovation in Medical Education, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Chilombo', 'Initials': 'C', 'LastName': 'Bould', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8M2, Canada.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Lam', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Joseph K', 'Initials': 'JK', 'LastName': 'Burns', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Moffett', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8M2, Canada.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'McBride', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8M2, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'M Dylan', 'Initials': 'MD', 'LastName': 'Bould', 'Affiliation': 'Department of Innovation in Medical Education, University of Ottawa, Ottawa, ON, Canada.'}]",CJEM,['10.1007/s43678-022-00291-3']
802,35438424,Maximal strength training in patients with inflammatory rheumatic disease: implications for physical function and quality of life.,"PURPOSE


Patients with inflammatory rheumatic disease (IRD) have attenuated muscle strength in the lower extremities, resulting in impaired physical function and quality of life. Although maximal strength training (MST), applying heavy resistance, is documented to be a potent countermeasure for such attenuation, it is uncertain if it is feasible in IRD given the pain, stiffness, and joint swelling that characterize the population.
METHODS


23 patients with IRD (49 ± 13 years; 20 females/3 males), diagnosed with spondyloarthritis, rheumatoid arthritis, or systemic lupus erythematosus, were randomized to MST or a control group (CG). The MST group performed four × four repetitions dynamic leg press two times per week for 10 weeks at ~ 90% of one repetition maximum (1RM). Before and after training 1RM, rate of force development (RFD), and health-related quality of life (HRQoL) were measured.
RESULTS


Session attendance in the MST group was 95%, of which 95% conducted according to MST protocol. Furthermore, MST increased 1RM (29 ± 12%, p = 0.001) and early and late phase RFD (33-76%, p < 0.05). All improvements were different from the CG (p < 0.05). MST also resulted in HRQoL improvements in the dimensions; physical functioning, general health, and vitality (p < 0.05). Physical functioning was associated with 1RM (rho = 0.55, p < 0.01) and early phase RFD (rho = 0.53-0.71, p < 0.01; different from CG p < 0.05).
CONCLUSIONS


Despite being characterized by pain, stiffness, and joint swelling, patients with IRD appear to tolerate MST well. Given the improvements in 1RM, RFD, and HRQoL MST should be considered as a treatment strategy to counteract attenuated muscle strength, physical function, and HRQoL.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04998955, retrospectively registered.",2022,"MST also resulted in HRQoL improvements in the dimensions; physical functioning, general health, and vitality (p < 0.05).","['23 patients with IRD (49\u2009±\u200913\xa0years; 20 females/3 males), diagnosed with spondyloarthritis, rheumatoid arthritis, or systemic lupus erythematosus', 'Patients with inflammatory rheumatic disease (IRD', 'patients with inflammatory rheumatic disease']","['maximal strength training (MST', 'MST', 'Maximal strength training']","['rate of force development (RFD), and health-related quality of life (HRQoL', 'Furthermore, MST increased 1RM', 'early phase RFD', 'Physical functioning', 'physical functioning, general health, and vitality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]",23.0,0.0288306,"MST also resulted in HRQoL improvements in the dimensions; physical functioning, general health, and vitality (p < 0.05).","[{'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Haglo', 'Affiliation': 'Faculty of Health and Social Sciences, Molde University College, Molde, Norway. havard@treningsklinikken.no.'}, {'ForeName': 'Ole Kristian', 'Initials': 'OK', 'LastName': 'Berg', 'Affiliation': 'Faculty of Health and Social Sciences, Molde University College, Molde, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoff', 'Affiliation': 'Myworkout, Medical Rehabilitation Clinic, Ingvald Ystgaards veg 23, 7047, Trondheim, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Helgerud', 'Affiliation': 'Myworkout, Medical Rehabilitation Clinic, Ingvald Ystgaards veg 23, 7047, Trondheim, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Faculty of Health and Social Sciences, Molde University College, Molde, Norway.'}]",European journal of applied physiology,['10.1007/s00421-022-04948-w']
803,35441435,"The effects of empagliflozin, dietary energy restriction, or both on appetite-regulatory gut peptides in individuals with type 2 diabetes and overweight or obesity: The SEESAW randomized, double-blind, placebo-controlled trial.","AIM


To assess the impact of the sodium-glucose co-transporter-2 (SGLT2) inhibitor empagliflozin (25 mg once-daily), dietary energy restriction, or both combined, on circulating appetite-regulatory peptides in people with type 2 diabetes (T2D) and overweight or obesity.
MATERIALS AND METHODS


In a double-blind, placebo-controlled trial, 68 adults (aged 30-75 years) with T2D (drug naïve or on metformin monotherapy; HbA1c 6.0%-10.0% [42-86 mmol/mol]) and body mass index of 25 kg/m 2  or higher were randomized to (a) placebo only, (b) placebo plus diet, (c) empagliflozin only or (d) empagliflozin plus diet for 24 weeks. Dietary energy restriction matched the estimated energy deficit elicited by SGLT2 inhibitor therapy through urinary glucose excretion (~360 kcal/day). The primary outcome was change in postprandial circulating total peptide-YY (PYY) during a 3-hour mixed-meal tolerance test from baseline to 24 weeks. Postprandial total glucagon-like peptide-1 (GLP-1), acylated ghrelin and subjective appetite perceptions formed secondary outcomes, along with other key components of energy balance.
RESULTS


The mean weight loss in each group at 24 weeks was 0.44, 1.91, 2.22 and 5.74 kg, respectively. The change from baseline to 24 weeks in postprandial total PYY was similar between experimental groups and placebo only (mean difference [95% CI]: -8.6 [-28.6 to 11.4], 13.4 [-6.1 to 33.0] and 1.0 [-18.0 to 19.9] pg/ml in placebo-plus diet, empagliflozin-only and empagliflozin-plus-diet groups, respectively [all P ≥ .18]). Similarly, there was no consistent pattern of difference between groups for postprandial total GLP-1, acylated ghrelin and subjective appetite perceptions.
CONCLUSIONS


In people with T2D and overweight or obesity, changes in postprandial appetite-regulatory gut peptides may not underpin the less than predicted weight loss observed with empagliflozin therapy.
CLINICAL TRIALS REGISTRATION


NCT02798744, www.
CLINICALTRIALS


gov; 2015-001594-40, www.EudraCT.ema.europa.eu; ISRCTN82062639, www.ISRCTN.org.",2022,"Postprandial total glucagon-like peptide-1 (GLP-1), acylated ghrelin and subjective appetite perceptions","['people with type 2 diabetes (T2D) and overweight or obesity', 'people with T2D and overweight or obesity', 'individuals with type 2 diabetes and overweight or obesity', '68 adults (age 30-75\u2009years) with T2D (drug naïve or on metformin monotherapy; HbA1c 6.0-10.0% [42-86mmol/mol]) and BMI ≥25kg/m 2']","['placebo-only, (2) placebo-plus-diet, (3) empagliflozin-only, or (4) empagliflozin-plus-diet', 'SGLT2 inhibitor therapy', 'placebo-plus-diet, empagliflozin', 'empagliflozin-plus-diet', 'SGLT2 inhibitor empagliflozin', 'empagliflozin, dietary energy restriction, or both on appetite-regulatory gut peptides', 'placebo']","['postprandial total PYY', 'Postprandial total glucagon-like peptide-1 (GLP-1), acylated ghrelin and subjective appetite perceptions', 'post-prandial total GLP-1, acylated ghrelin, and subjective appetite perceptions', 'postprandial circulating total peptide-YY (PYY) during a 3-hour mixed-meal tolerance test', 'energy balance', 'mean weight loss']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",68.0,0.722688,"Postprandial total glucagon-like peptide-1 (GLP-1), acylated ghrelin and subjective appetite perceptions","[{'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Redman', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Danielle H', 'Initials': 'DH', 'LastName': 'Bodicoat', 'Affiliation': 'Simplified Data, Leicester, UK.'}, {'ForeName': 'Sudesna', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'Milton Keynes University Hospital, Milton Keynes, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Poulin', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Ghazala', 'Initials': 'G', 'LastName': 'Waheed', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Waller', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Department of Cardiovascular and Metabolic Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14721']
804,35441396,Potential Adverse Effect of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) on Bisphosphonate Efficacy: An Exploratory Post Hoc Analysis From a Randomized Controlled Trial of Clodronate.,"Nonsteroidal anti-inflammatory drugs (NSAIDs) have been reported to have weak but beneficial effects on bone health, including fracture risk, but many epidemiological studies are likely confounded. We explored the relationship between NSAIDs and fracture risk in a post hoc analysis of a well-documented, randomized, placebo-controlled study of the bisphosphonate, clodronate, in which treatment reduced osteoporotic fracture risk by 23%. Concurrent medication use at baseline was used to identify those prescribed oral NSAIDs. Only verified, incident fractures were included in the analysis. A total of 1082 (20.8%) women reported use of NSAIDs at baseline. They were slightly, but significantly, younger (mean 79 versus 80 years, p = 0.004), heavier (mean 66.7 versus 64.7 kg, p < 0.001) than nonusers, with slightly higher femoral neck bone mineral density (FN-BMD, 0.66 versus 0.64 g/cm 2  , p < 0.001). In an adjusted model, NSAID use was associated with a significant increase in osteoporotic fracture risk over the 3-year study period (hazard ratio [HR] 1.27; 95% confidence interval [CI], 1.01-1.62; p = 0.039). However, this increase in risk was not statistically significant in the placebo group (HR 1.11; 95% CI, 0.81-1.52). In women receiving clodronate, the effect of the bisphosphonate to reduce osteoporotic fracture risk was not observed in those receiving NSAIDs (HR 0.95; 95% CI, 0.65-1.41; p = 0.81) in contrast to those not using NSAIDs (HR 0.71; 95% CI, 0.58-0.89; p = 0.002). In a subset with hip BMD repeated at 3 years, BMD loss during clodronate therapy was greater in those women receiving NSAIDs than in nonusers (eg, total hip -2.75% versus -1.27%, p = 0.078; femoral neck -3.06% versus -1.12%, p = 0.028), and was not significantly different from that observed in women receiving placebo. The efficacy of the bisphosphonate, clodronate, to reduce fracture risk was largely negated in those receiving NSAIDs. Although the mechanism is unclear, this clinically significant observation requires exploration in studies of commonly used bisphosphonates. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).",2022,"However, this increase in risk was not statistically significant in the placebo group (HR 1.11; 95% CI, 0.81-1.52).",['© 2022'],"['Nonsteroidal Anti-Inflammatory Drugs (NSAIDs', 'clodronate', 'bisphosphonate', 'Nonsteroidal anti-inflammatory drugs (NSAIDs', 'bisphosphonate, clodronate', 'placebo', 'Clodronate']","['osteoporotic fracture risk', 'fracture risk', 'femoral neck bone mineral density', 'BMD loss', 'risk', 'Bisphosphonate Efficacy']",[],"[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0162357', 'cui_str': 'Clodronate'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.10819,"However, this increase in risk was not statistically significant in the placebo group (HR 1.11; 95% CI, 0.81-1.52).","[{'ForeName': 'Zhangan', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Mellanby Centre for Musculoskeletal Research, Medical Research Council (MRC) Versus Arthritis Centre for Integrated Research in Musculoskeletal Ageing, Department of Oncology & Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Sahlgrenska Osteoporosis Centre, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Lorentzon', 'Affiliation': 'Sahlgrenska Osteoporosis Centre, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Vandenput', 'Affiliation': 'Sahlgrenska Osteoporosis Centre, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Enwu', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kanis', 'Affiliation': 'Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Eugene V', 'Initials': 'EV', 'LastName': 'McCloskey', 'Affiliation': 'Mellanby Centre for Musculoskeletal Research, Medical Research Council (MRC) Versus Arthritis Centre for Integrated Research in Musculoskeletal Ageing, Department of Oncology & Metabolism, University of Sheffield, Sheffield, UK.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4548']
805,35441378,Statistical power and sample size requirements to detect an intervention by time interaction in four-level longitudinal cluster randomized trials.,"Cluster/group randomized controlled trials (CRTs) have a long history in the study of health sciences. CRT is a special type of intervention trial in which a complete group is randomly assigned to a study condition (or intervention). It is typically performed when individual randomization is difficult/impossible without substantial risk of contamination across study arms or prohibitive from the cost or group dynamics point of view. In this article, the aim is to design and analyze four-level longitudinal cluster randomized trials. The main interest here is to study the difference between treatment groups over time for such a four-level hierarchical data structure. This work is motivated by a real-life study for education based HIV prevention. Such trials are not only popular for administrative convenience, ethical considerations, subject compliance, but also help to reduce contamination bias. A random intercept mixed effects linear regression including a time by intervention interaction is used for modeling. Closed form expression of the power function to detect the interaction effect is determined. Sample size equations depend on correlation among schools but not on correlations among classes or students while, the power function depends on the product of number of units at different levels. Optimal allocation of units under a fixed cost by minimizing the expected standardized variance is also determined and are shown to be independent of correlations among units in any level. Results of detailed simulation studies find the theoretical power estimates based on the derived formulae close to the empirical estimates.",2022,Optimal allocation of units under a fixed cost by minimizing the expected standardized variance is also determined and are shown to be independent of correlations among units in any level.,[],['CRT'],[],[],"[{'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}]",[],,0.0516448,Optimal allocation of units under a fixed cost by minimizing the expected standardized variance is also determined and are shown to be independent of correlations among units in any level.,"[{'ForeName': 'Samiran', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Siuli', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Mathematics, Indian Institute of Technology Bombay, Mumbai, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Majumder', 'Affiliation': 'Department of Mathematics, Indian Institute of Technology Bombay, Mumbai, India.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Massachusetts, USA.'}]",Statistics in medicine,['10.1002/sim.9369']
806,35452830,The effects of continuous renal replacement therapy with different anticoagulation methods on the expression of cytokines in severe acute pancreatitis.,"OBJECTIVE


Severe acute pancreatitis (SAP) is a highly morbid condition in general population as well as in solid organ transplant (SOT) recipients. The present study aimed to investigate the effect of continuous renal replacement therapy (CRRT) with different anticoagulation methods on the expression levels of cytokines in SAP.
METHODS


A total of 120 patients with SAP, admitted into our hospital between September 2017 and July 2020, were enrolled as the research subjects and randomly divided into a control group (60 cases) and a study group (60 cases). CRRT with low molecular weight (LMW) heparin‑calcium anticoagulation was conducted on patients in the control group, and CRRT with topical citrate + low-dose LMW heparin‑calcium anticoagulation was conducted on patients in the study group. The expressions of cytokines in the two groups were compared after treatment.
RESULTS


There was no significant difference in white blood cells (WBC), C-reactive proteins (CRP), and procalcitonin (PCT) before treatment between the two groups (P > 0.05). After treatment, the levels of WBC (P = 0.006), CRP (P < 0.001), and PCT (P < 0.001) were significantly lower in the study group when compared with those in the control group. There was no significant difference in the concentrations of interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor-α (TNF-α) between the two groups before treatment (P > 0.05). After treatment, the concentrations of IL-6, IL-8, and TNF-α were significantly lower in the study group when compared with those in the control group. The APACHEII, SOFA and Ranson scores of the two groups were analyzed, and there was no difference between the two groups before treatment (P > 0.05). After treatment, the score of the study group was lower than that of the control group (P < 0.05).
CONCLUSION


CRRT with topical citrate + low-dose LMW heparin‑calcium anticoagulation in the treatment of patients with SAP reduces the levels of WBC, CRP, and PCT and the concentrations of cytokines, including IL-6, IL-8, and TNF-α. This inhibits the release of inflammatory mediators in patients with SAP and reduces damage to the body caused by the inflammatory response, thus effectively improving the patients' condition.",2022,"After treatment, the concentrations of IL-6, IL-8, and TNF-α were significantly lower in the study group when compared with those in the control group.","['120 patients with SAP, admitted into our hospital between September 2017 and July 2020', 'Severe acute pancreatitis (SAP', 'patients with SAP', 'severe acute pancreatitis']","['CRRT with low molecular weight (LMW) heparin‑calcium anticoagulation', 'continuous renal replacement therapy', 'continuous renal replacement therapy (CRRT', 'CRRT with topical citrate + low-dose LMW heparin‑calcium anticoagulation']","['PCT', 'concentrations of interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor-α (TNF-α', 'APACHEII, SOFA and Ranson scores', 'white blood cells (WBC), C-reactive proteins (CRP), and procalcitonin (PCT', 'CRP', 'levels of WBC, CRP, and PCT and the concentrations of cytokines, including IL-6, IL-8, and TNF-α', 'concentrations of IL-6, IL-8, and TNF-α', 'expressions of cytokines', 'levels of WBC']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",120.0,0.0323304,"After treatment, the concentrations of IL-6, IL-8, and TNF-α were significantly lower in the study group when compared with those in the control group.","[{'ForeName': 'Zhi-Feng', 'Initials': 'ZF', 'LastName': 'Chen', 'Affiliation': ""Department of Critical Care Medicine, Changde First People's Hospital, No. 388 of Renmin Street, Wuling District, Changde City 415000,Hunan Province, China. Electronic address: zhifnegchendr@163.com.""}, {'ForeName': 'Chun-Mei', 'Initials': 'CM', 'LastName': 'Gui', 'Affiliation': ""Department of Critical Care Medicine, Changde First People's Hospital, No. 388 of Renmin Street, Wuling District, Changde City 415000,Hunan Province, China.""}, {'ForeName': 'Zhi-Hui', 'Initials': 'ZH', 'LastName': 'Xie', 'Affiliation': ""Department of Critical Care Medicine, Changde First People's Hospital, No. 388 of Renmin Street, Wuling District, Changde City 415000,Hunan Province, China.""}]",Transplant immunology,['10.1016/j.trim.2022.101603']
807,35459133,Acting with awareness moderates the association between lifetime exposure to interpersonal traumatic events and craving via trauma symptoms: a moderated indirect effects model.,"BACKGROUND


History of exposure to traumatic events (ETE) is common among women in substance use disorder (SUD) treatment and is related to craving. We examined whether ETE (i.e., emotional, physical, sexual abuse) in childhood, adulthood, or both is related to craving via trauma symptoms and how trait mindfulness might attenuate this association.
METHODS


Baseline data from a larger randomized clinical trial of a mindfulness-based intervention for women (N = 245) in SUD treatment were used. Inclusion criteria were: 18-65 years of age, SUD diagnosis, English fluency, no cognitive impairment, and willingness to be audio recorded and provide consent. Demographics and validated measures of ETE, posttraumatic stress symptoms, trait mindfulness, and substance use craving were collected via in-person interviews. Descriptive statistics, correlational analysis, and relative direct, indirect, and conditional indirect effects models were run.
RESULTS


Most participants identified as Hispanic (58.5%), had at least a high school education (52.2%), with a mean age of 32.2. Women reported ETE in childhood only (20.4%), adulthood only (17.5%), both childhood and adulthood (50.0%), and never (11.4%). Compared to women with ETE in both childhood and adulthood, those with exposure in adulthood only (β = -.10, 95% CI = -.20, -.02) or no exposure (β = -.11, 95% CI = -.23, -.03; [∆R 2=  .347, F(8, 245) = 15.7, p < .001) had lower craving via lower trauma symptomatology but no difference when compared to those with ETE only in childhood. Acting with awareness moderated this indirect effect (∆R 2  = .04, F(3, 245) = 4.66, p = .004. At low levels of awareness, women with ETE during both childhood and adulthood reported higher craving via trauma symptomatology than women with no exposure or only adulthood exposure.
CONCLUSIONS


Low levels of acting with awareness may worsen trauma symptoms after ETE, which in turn may lead to more craving for women in substance use treatment. Despite a small moderating effect size, acting with awareness may have clinical significance due to the prevalence of trauma symptoms among women in SUD treatment.",2022,"At low levels of awareness, women with ETE during both childhood and adulthood reported higher craving via trauma symptomatology than women with no exposure or only adulthood exposure.
","['for women (N\u2009=\u2009245) in SUD treatment were used', 'women in SUD treatment', 'Most participants identified as Hispanic (58.5%), had at least a high school education (52.2%), with a mean age of 32.2', 'Inclusion criteria were: 18-65\xa0years of age, SUD diagnosis, English fluency, no cognitive impairment, and willingness to be audio recorded and provide consent']",['mindfulness-based intervention'],"['craving via trauma symptomatology', 'ETE, posttraumatic stress symptoms, trait mindfulness, and substance use craving', 'lower craving via lower trauma symptomatology']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.130369,"At low levels of awareness, women with ETE during both childhood and adulthood reported higher craving via trauma symptomatology than women with no exposure or only adulthood exposure.
","[{'ForeName': 'Gladys E', 'Initials': 'GE', 'LastName': 'Ibañez', 'Affiliation': 'Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University, Florida, Miami, US. gibanez@fiu.edu.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Sanchez', 'Affiliation': 'Department of Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, Florida, Miami, US.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Villalba', 'Affiliation': 'Department of Population Health, College of Medicine, University of Central Florida, Florida, Miami, US.'}, {'ForeName': 'Hortensia', 'Initials': 'H', 'LastName': 'Amaro', 'Affiliation': 'Herbert Wertheim College of Medicine and Robert Stempel College of Public Health, Florida International University, Florida, Miami, US.'}]",BMC psychiatry,['10.1186/s12888-022-03931-1']
808,35459118,A randomized controlled trial to examine the effectiveness of the Dutch version of the Program for the Education and Enrichment of Relational Skills (PEERS®).,"BACKGROUND


This study examines the effectiveness of the culturally adapted Dutch version of The Program for the Education and Enrichment of Relational Skills (PEERS®), utilizing a randomized control trial (RCT) with an active treatment control condition.
METHODS


106 adolescents with ASD, aged 12-18 years, were randomly assigned to one of two group interventions: the experimental condition (PEERS®; n = 54) or the active treatment control condition (Regulation, Organization and Autonomy Didactics; ROAD; n = 52). Effects of interventions on social skills were primarily assessed using an observational measure (CASS - Contextual Assessment Social Skills). Secondary indices of social skills were self, parent and teacher reported questionnaire data (i.e., Social Responsiveness Scale; SRS, and Social Skills Improvement System; SSIS). Treatment satisfaction was also obtained from adolescents and their parents.
RESULTS


Results on the observational measure of social skills revealed improvements in positive affect, overall quality of rapport, as well as starting and ending a conversation, irrespective of condition. Compared to ROAD, PEERS® participants showed increased overall self-reported social skills (SSIS). Parent reports showed decreased overall social skill impairment (SRS) as well as improved social communication (SSIS subscale), with significantly more progress in the PEERS® group. Furthermore, parents of adolescents in the PEERS® group were significantly more satisfied with the intervention (M = 8.20, SD = 1.46) than parents of adolescents in the ROAD group (M = 7.52, SD = 1.45). The self-reported treatment satisfaction of adolescents did not differ between conditions. Teacher data showed decreased social skill impairment as measured with the SRS, irrespective of condition.
CONCLUSIONS


This study reveals promising indications that the Dutch version of PEERS® enhances social skills in adolescents with ASD. Yet, further research is needed into how effectiveness can be optimized.
TRIAL REGISTRATION


Dutch trail register NTR6255 (NL6117) 08/02/2017 https://www.trialregister.nl/trial/6117.",2022,"Furthermore, parents of adolescents in the PEERS® group were significantly more satisfied with the intervention (M = 8.20, SD = 1.46) than parents of adolescents in the ROAD group (M = 7.52, SD = 1.45).","['106 adolescents with ASD, aged 12-18\xa0years', 'adolescents with ASD']","['experimental condition (PEERS®; n\u2009=\u200954) or the active treatment control condition (Regulation, Organization and Autonomy Didactics; ROAD; n\u2009=\u200952', 'culturally adapted Dutch version of The Program for the Education and Enrichment of Relational Skills (PEERS®', 'PEERS®', 'Dutch version of the Program for the Education and Enrichment of Relational Skills (PEERS®']","['positive affect, overall quality of rapport', 'Treatment satisfaction', 'overall self-reported social skills (SSIS', 'overall social skill impairment (SRS', 'social communication (SSIS subscale', 'social skills', 'social skills were self, parent and teacher reported questionnaire data (i.e., Social Responsiveness Scale; SRS, and Social Skills Improvement System; SSIS', 'social skill impairment', 'observational measure (CASS - Contextual Assessment Social Skills']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0643514', 'cui_str': '6-chloropenicillanic acid S-sulfoxide'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",106.0,0.0281958,"Furthermore, parents of adolescents in the PEERS® group were significantly more satisfied with the intervention (M = 8.20, SD = 1.46) than parents of adolescents in the ROAD group (M = 7.52, SD = 1.45).","[{'ForeName': 'Sakinah', 'Initials': 'S', 'LastName': 'Idris', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, Wytemaweg 8, 3015 CN, Rotterdam, The Netherlands.""}, {'ForeName': 'Bjorn Jaime', 'Initials': 'BJ', 'LastName': 'van Pelt', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, Wytemaweg 8, 3015 CN, Rotterdam, The Netherlands.""}, {'ForeName': 'Gabrine', 'Initials': 'G', 'LastName': 'Jagersma', 'Affiliation': 'GGZ Rivierduinen Children and Youth, Institute for Mental Health, Leiden, The Netherlands.'}, {'ForeName': 'Jorieke', 'Initials': 'J', 'LastName': 'Duvekot', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, Wytemaweg 8, 3015 CN, Rotterdam, The Netherlands.""}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Yulius Organization for Mental Health, Burg. De Raadtsingel 93c, 3311 JG, Dordrecht, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Ende', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, Wytemaweg 8, 3015 CN, Rotterdam, The Netherlands.""}, {'ForeName': 'Neeltje', 'Initials': 'N', 'LastName': 'van Haren', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, Wytemaweg 8, 3015 CN, Rotterdam, The Netherlands.""}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Greaves-Lord', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, Wytemaweg 8, 3015 CN, Rotterdam, The Netherlands. k.greaves-lord@rug.nl.""}]",BMC psychiatry,['10.1186/s12888-022-03913-3']
809,35459114,Effects of supervised high-intensity hardstyle kettlebell training on grip strength and health-related physical fitness in insufficiently active older adults: the BELL pragmatic controlled trial.,"The Ballistic Exercise of the Lower Limb (BELL) trial examined the efficacy and safety of a pragmatic hardstyle kettlebell training program in older adults. Insufficiently active men and women aged 59-79 years, were recruited to a 6-month repeated measures study, involving 3-months usual activity and 3-months progressive hardstyle kettlebell training. Health-related physical fitness outcomes included: grip strength [GS], 6-min walk distance [6MWD], resting heart rate [HR], stair-climb [SC], leg extensor strength [LES], hip extensor strength [HES], Sit-To-Stand [STS], vertical jump [CMVJ], five-times floor transfer [5xFT], 1RM deadlift, body composition (DXA), attendance, and adverse events. Sixteen males (68.8 ± 4.6 yrs, 176.2 ± 7.8 cm, 90.7 ± 11.0 kg, 29.2 ± 2.6 kg/m 2 ) and sixteen females (68.6 ± 4.7 yrs, 163.9 ± 5.4 cm, 70.4 ± 12.7 kg, 26.3 ± 4.9 kg/m 2 ) were recruited. Compliance with the supervised exercise program was very high (91.5%). Kettlebell training increased GS (R: MD = 7.1 kg 95% CI [4.9, 9.3], L: MD = 6.3 kg 95% CI [4.1, 8.4]), 6MWD (41.7 m, 95% CI [17.9, 65.5]), 1RM (16.2 kg, 95% CI [2.4, 30.0]), 30 s STS (3.3 reps, 95% CI [0.9, 5.7]), LES (R: MD = 61.6 N, 95% CI [4.4, 118.8]), HES (L: MD = 21.0 N,95% CI [4.2,37.8]), appendicular skeletal lean mass (MD = 0.65 kg, 95% CI [0.08, 1.22]), self-reported health change (17.1%, 95% CI [4.4, 29.8]) and decreased SC time (2.7 s, 95% CI [0.2, 5.2]), 5xFT time (6.0 s, 95% CI [2.2, 9.8]) and resting HR (7.4 bpm, 95% CI [0.7, 14.1]). There were four non-serious adverse events. Mean individual training load for group training sessions during the trial was 100,977 ± 9,050 kg. High-intensity hardstyle kettlebell training was well tolerated and improved grip strength and measures of health-related physical fitness in insufficiently active older adults.Trial registration: Prospectively registered: 20/08/2019, Australian New Zealand Clinical Trials Registry (ACTRN12619001177145).",2022,High-intensity hardstyle kettlebell training was well tolerated and improved grip strength and measures of health-related physical fitness in insufficiently active older adults.,"['Sixteen males (68.8 ± 4.6 yrs, 176.2 ± 7.8\xa0cm, 90.7 ± 11.0\xa0kg, 29.2 ± 2.6\xa0kg/m 2 ) and sixteen females (68.6 ± 4.7 yrs, 163.9 ± 5.4\xa0cm, 70.4 ± 12.7\xa0kg, 26.3 ± 4.9\xa0kg/m 2 ) were recruited', 'Insufficiently active men and women aged 59-79\xa0years', 'insufficiently active older adults', 'older adults']","['supervised exercise program', 'supervised high-intensity hardstyle kettlebell training', 'High-intensity hardstyle kettlebell training', 'pragmatic hardstyle kettlebell training program']","['GS', 'grip strength [GS], 6-min walk distance [6MWD], resting heart rate [HR], stair-climb [SC], leg extensor strength [LES], hip extensor strength [HES], Sit-To-Stand [STS], vertical jump [CMVJ], five-times floor transfer [5xFT], 1RM deadlift, body composition (DXA), attendance, and adverse events', '1RM', 'tolerated and improved grip strength and measures of health-related physical fitness', 'grip strength and health-related physical fitness', '5xFT time', 'self-reported health change', 'appendicular skeletal lean mass', 'resting HR', 'efficacy and safety', '6MWD', 'SC time']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0686186,High-intensity hardstyle kettlebell training was well tolerated and improved grip strength and measures of health-related physical fitness in insufficiently active older adults.,"[{'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Meigh', 'Affiliation': 'Institute of Health & Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Robina, QLD, 4226, Australia. nmeigh@bond.edu.au.'}, {'ForeName': 'Justin W L', 'Initials': 'JWL', 'LastName': 'Keogh', 'Affiliation': 'Institute of Health & Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Robina, QLD, 4226, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Schram', 'Affiliation': 'Institute of Health & Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Robina, QLD, 4226, Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Hing', 'Affiliation': 'Institute of Health & Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Robina, QLD, 4226, Australia.'}, {'ForeName': 'Evelyne N', 'Initials': 'EN', 'LastName': 'Rathbone', 'Affiliation': 'Institute of Health & Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Robina, QLD, 4226, Australia.'}]",BMC geriatrics,['10.1186/s12877-022-02958-z']
810,35421233,"Red Raspberry and Fructo-Oligosaccharide Supplementation, Metabolic Biomarkers, and the Gut Microbiota in Adults with Prediabetes: A Randomized Crossover Clinical Trial.","BACKGROUND


Evidence suggests that the gut microbiota and cardiometabolic status are associated, suggesting dietary interventions that alter the microbiota may affect metabolic health.
OBJECTIVES


We investigated whether supplementation with (poly)phenol-dense red raspberries (RRB), alone or with a fructo-oligosaccharide (FOS) prebiotic, would improve biomarkers of cardiometabolic risk in individuals with prediabetes (PreDM) and insulin resistance (IR) and whether the effects are related to modulation of the gut microbiota.
METHODS


Adults with PreDM-IR (n = 26; mean ± SEM age, 35 ± 2 years; fasting glucose, 5.7 ± 0.1 mmol/L; HOMA-IR, 3.3 ± 0.3) or who were metabolically healthy (reference group; n = 10; age, 31 ± 3 years; fasting glucose, 5.1 ± 0.2 mmol/L; HOMA-IR, 1.1 ± 0.1) participated in a randomized crossover trial with two 4-week supplementation periods, in which they consumed either RRB (125 g fresh equivalents) daily or RRB + 8g FOS daily, separated by a 4-week washout. The primary outcome variable was the change in the gut microbiota composition, assessed by shotgun sequencing before (baseline) and at the end of each supplementation period. Secondary outcomes were changes in glucoregulation, lipid metabolism, anti-inflammatory status, and anthropometry. The trial is registered at ClinicalTrials.gov, NCT03049631.
RESULTS


In PreDM-IR, RRB supplementation reduced hepatic-IR (-30.1% ± 14.6%; P = 0.04) and reduced plasma total and LDL cholesterol [-4.9% ± 1.8% (P = 0.04) and -7.2% ± 2.3% (P = 0.003), respectively] from baseline. Adding FOS (RRB + FOS) improved β-cell function [insulin secretion rate, +70.2% ± 32.8% (P = 0.02); Disposition Index, +94.4% ± 50.2% (P = 0.04)], but had no significant effect on plasma cholesterol compared to baseline. RRB increased Eubacterium eligens (2-fold) and decreased Ruminococcus gnavus (-60% ± 34%), whereas RRB + FOS increased Bifidobacterium spp. (4-fold) and decreased Blautia wexlerae (-23% ± 12%) from baseline (all P values ≤ 0.05). R. gnavus was positively correlated with hepatic-IR, and E. eligens and Bifidobacterium catenulatum were negatively correlated with cholesterol concentrations (P ≤ 0.05).
CONCLUSIONS


Increased Bifidobacterium spp., concurrently with reduced R. gnavus, was associated with metabolic improvements in adults with PreDM-IR, warranting further research on the mechanisms involved in (poly)phenol/FOS-microbial interactions with host metabolism.",2022,"RRB increased Eubacterium eligens (2-fold) and decreased Ruminococcus gnavus (-60 ± 34%), whereas RRB + FOS increased Bifidobacterium spp.","['Adults with Prediabetes', 'SEM age, 35\xa0±\xa02 y; fasting glucose, 5.7\xa0±\xa00.1\xa0mmol/L; Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), 3.3\xa0±\xa00.3) or who were metabolically healthy (Reference, n\xa0=\xa010, age, 31\xa0±\xa03 y; fasting glucose, 5.1\xa0±\xa00.2\xa0mmol/L; HOMA-IR, 1.1\xa0±\xa00.1', 'Adults with PreDM-IR (n\xa0', 'individuals with prediabetes and insulin resistance (PreDM-IR']","['FOS (RRB\xa0+\xa0FOS', 'supplementation periods consuming RRB', 'RRB\xa0', 'supplementation with (poly)phenol-dense red raspberries (RRB) alone or with fructo-oligosaccharide (FOS) prebiotic']","['Hepatic Insulin-Resistance', 'hepatic insulin-resistance, and E. eligens and Bifidobacterium catenulatum', '26, mean\xa0±', 'changes in glucoregulation, lipid metabolism, anti-inflammatory status, and anthropometry', 'RRB increased Eubacterium eligens', 'RRB\xa0+\xa0FOS increased Bifidobacterium spp', 'β-cell function (Insulin Secretion Rate', 'cholesterol concentrations', 'plasma cholesterol', 'plasma total and LDL cholesterol', 'change in gut microbiota composition assessed by shotgun sequencing', 'Blautia wexlerae']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0453292', 'cui_str': 'Raspberries'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0314984', 'cui_str': 'Bifidobacterium catenulatum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0453292', 'cui_str': 'Raspberries'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0317503', 'cui_str': 'Eubacterium eligens'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0037003', 'cui_str': 'Shotgun'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C2658870', 'cui_str': 'Blautia'}]",,0.262094,"RRB increased Eubacterium eligens (2-fold) and decreased Ruminococcus gnavus (-60 ± 34%), whereas RRB + FOS increased Bifidobacterium spp.","[{'ForeName': 'Xuhuiqun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and the Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Anqi', 'Initials': 'A', 'LastName': 'Zhao', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and the Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Amandeep K', 'Initials': 'AK', 'LastName': 'Sandhu', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and the Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and the Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Britt M', 'Initials': 'BM', 'LastName': 'Burton-Freeman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and the Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxac037']
811,35426351,Physical Exercise Affects Quality of Life and Cardiac Autonomic Modulation in Patients With Chronic Kidney Failure Submitted to Hemodialysis: A Randomized Clinical Trial.,"Performing physical exercise during hemodialysis has been debated regarding safety and efficacy for improving life quality for patients with chronic kidney disease (CKD). Thus, we explored the influence of physical exercise during hemodialysis on both autonomic modulation of heart rate and quality of life for patients with CKF in a randomized clinical trial. We randomly allocated participants requiring hemodialysis to an experimental exercise group (EG) and a control no-exercise group (CG) and assessed their quality of life with the Kidney Disease Quality of Life Short Form-KDQOL-SF ™  1.3 and with Polar RS800CX to monitor their heart rate variability (HRV) before and three months after the end of the exercise intervention. EG participants reported a significant increase in their quality of life ( p  = .05, physical function, physical aspects, pain, emotional well-being, emotional function;  p  = .03, energy and fatigue) and showed HRV improvement ( p  = .05, RMSSD, SDNN, and SD2;  p =  .004, SD1) after three months of exercise. Thus, we recommend supervised physical exercise during hemodialysis for carefully selected patients.",2022,"EG participants reported a significant increase in their quality of life ( p  = .05, physical function, physical aspects, pain, emotional well-being, emotional function;  ","['Patients', 'patients with chronic kidney disease (CKD', 'patients with CKF']","['Physical Exercise', 'supervised physical exercise', 'physical exercise', 'hemodialysis to an experimental exercise group (EG) and a control no-exercise group (CG) and assessed their quality of life with the Kidney Disease Quality of Life Short Form-KDQOL-SF ™  1.3 and with Polar RS800CX', 'Hemodialysis']","['physical function, physical aspects, pain, emotional well-being, emotional function', 'energy and fatigue) and showed HRV improvement', 'quality of life', 'Quality of Life and Cardiac Autonomic Modulation', 'heart rate and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0214576,"EG participants reported a significant increase in their quality of life ( p  = .05, physical function, physical aspects, pain, emotional well-being, emotional function;  ","[{'ForeName': 'Ana Beatriz Nunes', 'Initials': 'ABN', 'LastName': 'Pereira', 'Affiliation': '306972Department of Human Movement Sciences, University of Pará State, Belém, Brazil.'}, {'ForeName': 'Larissa Lopes', 'Initials': 'LL', 'LastName': 'Santana', 'Affiliation': '306972Department of Human Movement Sciences, University of Pará State, Belém, Brazil.'}, {'ForeName': 'Letícia De Barros', 'Initials': 'LB', 'LastName': 'Rocha', 'Affiliation': '306972Department of Human Movement Sciences, University of Pará State, Belém, Brazil.'}, {'ForeName': 'Katiane Da Costa', 'Initials': 'KDC', 'LastName': 'Cunha', 'Affiliation': '306972Department of Morphology and Physiological Sciences, University of Pará State, Belém, Brazil.'}, {'ForeName': 'Larissa Salgado De Oliveira', 'Initials': 'LSO', 'LastName': 'Rocha', 'Affiliation': '306972Department of Physical Therapy, Universitary Center of Pará, Belém, Brazil.'}, {'ForeName': 'Marcio Clementino De Souza', 'Initials': 'MCS', 'LastName': 'Santos', 'Affiliation': '306972Department of Human Movement Sciences, University of Pará State, Belém, Brazil.'}, {'ForeName': 'Valéria Marques Ferreira', 'Initials': 'VMF', 'LastName': 'Normando', 'Affiliation': '306972Department of Human Movement Sciences, University of Pará State, Belém, Brazil.'}, {'ForeName': 'Daniel Da Costa', 'Initials': 'DDC', 'LastName': 'Torres', 'Affiliation': '306972Department of Human Movement Sciences, University of Pará State, Belém, Brazil.'}, {'ForeName': 'Rodrigo Santiago Barbosa', 'Initials': 'RSB', 'LastName': 'Rocha', 'Affiliation': '306972Department of Human Movement Sciences, University of Pará State, Belém, Brazil.'}]",Perceptual and motor skills,['10.1177/00315125221085811']
812,35428982,"Randomized phase 2 study of ACE-083, a muscle-promoting agent, in facioscapulohumeral muscular dystrophy.","INTRODUCTION/AIMS


Facioscapulohumeral muscular dystrophy (FSHD) is a slowly progressive muscular dystrophy without approved therapies. In this study we evaluated whether locally acting ACE-083 could safely increase muscle volume and improve functional outcomes in adults with FSHD.
METHODS


Participants were at least 18 years old and had FSHD1/FSHD2. Part 1 was open label, ascending dose, assessing safety and tolerability (primary objective). Part 2 was randomized, double-blind for 6 months, evaluating ACE-083240 mg/muscle vs placebo injected bilaterally every 3 weeks in the biceps brachii (BB) or tibialis anterior (TA) muscles, followed by 6 months of open label. Magnetic resonance imaging measures included total muscle volume (TMV; primary objective), fat fraction (FF), and contractile muscle volume (CMV). Functional measures included 6-minute walk test, 10-meter walk/run, and 4-stair climb (TA group), and performance of upper limb midlevel/elbow score (BB group). Strength, patient-reported outcomes (PROs), and safety were also evaluated.
RESULTS


Parts 1 and 2 enrolled 37 and 58 participants, respectively. Among 55 participants evaluable in Part 2, the least-squares mean (90% confidence interval, analysis of covariance) treatment difference for TMV was 16.4% (9.8%-23.0%) in the BB group (P < .0001) and 9.5% (3.2%-15.9%) in the TA group (P = .01). CMV increased significantly in the BB and TA groups and FF decreased in the TA group. There were no consistent improvements in functional or PRO measures in either group. The most common adverse events were mild or moderate injection-site reactions.
DISCUSSION


Significant increases in TMV with ACE-083 vs placebo did not result in consistent functional or PRO improvements with up to 12 months of treatment.",2022,"DISCUSSION


Significant increases in TMV with ACE-083 versus placebo did not result in consistent functional or PRO improvements with up to 12 months' treatment.","['18\u2009years old and had FSHD1/FSHD2', 'adults with FSHD', 'Participants were\u2009≥']","['ACE-083240\u2009mg/muscle versus placebo', 'Facioscapulohumeral muscular dystrophy (FSHD', ""biceps brachii (BB) or tibialis anterior (TA) muscles, followed by 6\u2009months' open-label"", 'locally acting ACE-083', 'ACE-083', 'placebo']","['functional or PRO measures', 'FF', 'Strength, patient-reported outcomes (PROs), safety', 'total muscle volume (TMV; primary objective), fat fraction (FF), and contractile muscle volume (CMV', 'functional or PRO improvements', '6-minute walk test, 10-m walk/run, and 4-stair climb (TA group), and performance of upper limb mid-level/elbow score', 'safety and tolerability', 'CMV', 'functional outcomes', 'TMV']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238288', 'cui_str': 'Facioscapulohumeral muscular dystrophy'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0238288', 'cui_str': 'Facioscapulohumeral muscular dystrophy'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.112423,"DISCUSSION


Significant increases in TMV with ACE-083 versus placebo did not result in consistent functional or PRO improvements with up to 12 months' treatment.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Statland', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Department of Pediatrics and Clinical Neurological Sciences, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Urvi', 'Initials': 'U', 'LastName': 'Desai', 'Affiliation': 'Carolinas MDA Care Center, Atrium Health, Charlotte, North Carolina, USA.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Neuromuscular Division, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Díaz-Manera', 'Affiliation': 'Neuromuscular Diseases Unit, Neurology Department, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Department of Neurology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Korngut', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genge', 'Affiliation': 'Montreal Neurological Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Rabi N', 'Initials': 'RN', 'LastName': 'Tawil', 'Affiliation': 'University of Rochester School of Medicine, Rochester, New York, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Elman', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nanette C', 'Initials': 'NC', 'LastName': 'Joyce', 'Affiliation': 'University of California Davis Medical Center, Davis, California, USA.'}, {'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Wagner', 'Affiliation': 'Johns Hopkins School of Medicine, Kennedy Krieger Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Manousakis', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Butterfield', 'Affiliation': 'Departments of Neurology and Pediatrics, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Perry B', 'Initials': 'PB', 'LastName': 'Shieh', 'Affiliation': 'University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wicklund', 'Affiliation': 'University of Colorado, Aurora, Colorado, USA.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Gamez', 'Affiliation': 'Department of Medicine, GMA Clinic, European Reference Network on Rare Neuromuscular Diseases (ERN EURO-NMD) and Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Bodkin', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pestronk', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Conrad C', 'Initials': 'CC', 'LastName': 'Weihl', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Vilchez-Padilla', 'Affiliation': 'Hospital UIP La Fe, Neuromuscular Reference Centre, Valencia, Spain.'}, {'ForeName': 'Nicholas E', 'Initials': 'NE', 'LastName': 'Johnson', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Mathews', 'Affiliation': 'Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Miller', 'Affiliation': 'Acceleron Pharma, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Leneus', 'Affiliation': 'Acceleron Pharma, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Marcie', 'Initials': 'M', 'LastName': 'Fowler', 'Affiliation': 'Acceleron Pharma, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'van de Rijn', 'Affiliation': 'Acceleron Pharma, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Attie', 'Affiliation': 'Acceleron Pharma, Cambridge, Massachusetts, USA.'}]",Muscle & nerve,['10.1002/mus.27558']
813,35429820,Patient-Specific Out-of-Pocket Cost Communication and Remote Financial Navigation in Patients with Multiple Sclerosis: A Randomized Controlled Feasibility Study.,"OBJECTIVE


We conducted a randomized controlled trial evaluating the feasibility of a personalized out-of-pocket cost communication, remote financial navigation and counseling (CostCOM) intervention in decreasing financial hardship among patients with multiple sclerosis (MS).
METHODS


Sixty-two adult patients with diagnosis of MS and a prescription for a disease modifying therapy were randomized into: (1) Usual care (n=30) and (2) CostCOM (n=32). CostCOM included patient-specific out-of-pocket cost communication, remote financial navigation and counseling delivered at enrollment and 3 months. Usual care included routine neurology visits, use of available ancillary staff, and internal or external resources for financial assistance per normal clinic procedures. Feasibility outcomes included participation in and satisfaction with CostCOM. Exploratory financial hardship outcomes included cost-related care nonadherence, material hardship, and financial worry using Comprehensive Score for Financial Toxicity (COST).
RESULTS


Mean age was 41.5 (81.0% female; 41.4% White and 51.7% Black race). Of 32 CostCOM patients, 96.8% and 68.7% completed baseline and follow-up intervention. A financial assistance application was completed for 80%. Mean general satisfaction (out of 5) with CostCOM was 3.1±1.0. In multivariable analyses, CostCOM patients had less financial worry (i.e., higher COST scores) at 3 months compared to usual care patients (B coefficient, 3.6; 95% CI (0.1 - 7.1). While CostCOM patients had significant decreases in 3 months non-adherence (72.7%) compared to enrollment (50%), their 3 months nonadherence and material hardship were not significantly different between the two arms.
CONCLUSION


CostCOM interventions are feasible, acceptable, and yield potential benefits in decreasing financial hardship.
TRIAL REGISTRATION


This study is registered at ClinicalTrials.gov (NCT04257071).",2022,"While CostCOM patients had significant decreases in 3 months non-adherence (72.7%) compared to enrollment (50%), their 3 months nonadherence and material hardship were not significantly different between the two arms.
","['patients with multiple sclerosis (MS', 'Sixty-two adult patients with diagnosis of MS and a prescription for a disease modifying therapy were randomized into: (1) Usual care (n=30) and (2) CostCOM (n=32', 'Patients with Multiple Sclerosis', 'Mean age was 41.5 (81.0% female; 41.4% White and 51.7% Black race']","['Usual care included routine neurology visits, use of available ancillary staff, and internal or external resources for financial assistance per normal clinic procedures', 'CostCOM interventions', 'personalized out-of-pocket cost communication, remote financial navigation and counseling (CostCOM) intervention']","['nonadherence and material hardship', 'Mean general satisfaction', 'participation in and satisfaction with CostCOM', 'cost-related care nonadherence, material hardship, and financial worry using Comprehensive Score for Financial Toxicity (COST', 'adherence', 'financial worry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3815933', 'cui_str': 'Uninsured medical expenses'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",62.0,0.0966422,"While CostCOM patients had significant decreases in 3 months non-adherence (72.7%) compared to enrollment (50%), their 3 months nonadherence and material hardship were not significantly different between the two arms.
","[{'ForeName': 'Gelareh', 'Initials': 'G', 'LastName': 'Sadigh', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine. Electronic address: gsadigh@emory.edu.'}, {'ForeName': 'Debrua', 'Initials': 'D', 'LastName': 'Coleman', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Lava', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Switchenko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Vargas', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Duszak', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor, MI.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2022.103797']
814,35435492,Fatigue strength of 5Y-FSZ: glazing and polishing effects.,"OBJECTIVE


The aim of this study was to evaluate the effect of four different finishing procedures on the fatigue strength of a fully stabilized zirconia (5Y-FSZ) material.
MATERIALS AND METHODS


Disc-shaped specimens of a 5Y-FSZ (Katana UTML, Kuraray Noritake) were made (ISO 6872-2015), grinded with 600- and 1200-grit silicon carbide paper, sintered as recommended, and randomly assigned into four groups according to the finishing technique: C (control, as-sintered), P (polished with polishing rubbers), G (glaze application - powder/liquid technique), and PG (polished with polishing rubbers + glaze application - powder/liquid). Then fatigue strength (staircase method), X-ray diffraction (XRD), and scanning electron microscopy (SEM) analyses were performed.
RESULTS


The C group presented the lowest fatigue strength, while the PG group presented the highest. The P and G groups presented intermediate behavior, presenting similar statistical results. XRD showed similar crystalline phase patterns for all groups. SEM images revealed some changes in the zirconia surface, with the P group presenting some scratches on the surface, while the scratches in the PG group were filled with the glaze material.
CONCLUSION


None of the techniques analyzed in this study impaired the fatigue strength of fully stabilized zirconia. Importantly, the polishing rubbers combined with glaze application (PG group) improved its fatigue strength.
CLINICAL RELEVANCE


The polishing rubbers followed by glaze application improve the fatigue strength in ultra-translucent zirconia.",2022,"SEM images revealed some changes in the zirconia surface, with the P group presenting some scratches on the surface, while the scratches in the PG group were filled with the glaze material.
","['Disc-shaped specimens of a 5Y-FSZ (Katana UTML, Kuraray Noritake) were made (ISO 6872-2015), grinded with 600- and 1200-grit silicon carbide paper, sintered as recommended']","['finishing technique: C (control, as-sintered), P (polished with polishing rubbers), G (glaze application - powder/liquid technique), and PG (polished with polishing rubbers\u2009+\u2009glaze application - powder/liquid']","['Fatigue strength', 'lowest fatigue strength', 'fatigue strength', 'fatigue strength (staircase method), X-ray diffraction (XRD), and scanning electron microscopy (SEM) analyses']","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0440273', 'cui_str': 'Grit'}, {'cui': 'C0074523', 'cui_str': 'Silicon carbide'}, {'cui': 'C0030351', 'cui_str': 'Paper'}]","[{'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043301', 'cui_str': 'Xray Diffraction'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0310127,"SEM images revealed some changes in the zirconia surface, with the P group presenting some scratches on the surface, while the scratches in the PG group were filled with the glaze material.
","[{'ForeName': 'Ana Beatriz Gomes', 'Initials': 'ABG', 'LastName': 'de Carvalho', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology, São Paulo State University, 777, Engenheiro Francisco José Longo Avenue, São José dos Campos, São Paulo, 12245-000, Brazil.'}, {'ForeName': 'Natália Inês', 'Initials': 'NI', 'LastName': 'Gonçalves', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology, São Paulo State University, 777, Engenheiro Francisco José Longo Avenue, São José dos Campos, São Paulo, 12245-000, Brazil.'}, {'ForeName': 'Tiago Moreira Bastos', 'Initials': 'TMB', 'LastName': 'Campos', 'Affiliation': 'Aeronautic Technological Institute (ITA), 50, Marechal Eduardo Gomes Square, São José dos Campos, SP, 12228-900, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Post-Graduate Program in Oral Science, Prosthodontic Unit, Federal University of Santa Maria, 1184, Marechal Floriano Peixoto Street, Santa Maria, RS, 97015-372, Brazil.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Post-Graduate Program in Oral Science, Prosthodontic Unit, Federal University of Santa Maria, 1184, Marechal Floriano Peixoto Street, Santa Maria, RS, 97015-372, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'de Siqueira Ferreira Anzaloni Saavedra', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology, São Paulo State University, 777, Engenheiro Francisco José Longo Avenue, São José dos Campos, São Paulo, 12245-000, Brazil.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Bottino', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology, São Paulo State University, 777, Engenheiro Francisco José Longo Avenue, São José dos Campos, São Paulo, 12245-000, Brazil.'}, {'ForeName': 'Rodrigo Othávio', 'Initials': 'RO', 'LastName': 'de Assunção E Souza', 'Affiliation': 'Department of Dentistry, Prosthodontic Unit, Federal University of Rio Grande Do Norte, 1787, Senador Salgado Filho Avenue, Natal, RN, 59380-000, Brazil.'}, {'ForeName': 'Renata Marques', 'Initials': 'RM', 'LastName': 'de Melo', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology, São Paulo State University, 777, Engenheiro Francisco José Longo Avenue, São José dos Campos, São Paulo, 12245-000, Brazil. marquesdemelo@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-022-04412-1']
815,35436644,Pregnant women's willingness to participate in a randomized trial comparing induction of labor at 39 weeks versus expectant management: A survey in the Netherlands.,"INTRODUCTION


A randomized controlled trial (RCT) in the United States, the ARRIVE trial, has indicated that induction of labor (IOL) in low-risk nulliparous women with a gestational age (GA) of 39 weeks compared to expectant management (EM) resulted in a significant lower rate of cesarean deliveries. The Dutch maternity care system is different compared to the United States with, among other factors, an overall significantly lower percentage of caesarean sections (CS). To investigate whether IOL has a favorable outcome in the Dutch maternity care system, a new trial is advised. In this questionnaire-based study we aim to evaluate whether Dutch low-risk pregnant women would be willing to participate in an RCT comparing IOL at 39 weeks to EM.
MATERIALS AND METHODS


We conducted an online survey in 2020 in the Netherlands. Respondent recruitment took place both in outpatient clinics at hospitals and midwife practices and via social media. Inclusion criteria were pregnant women with singleton gestation, GA ≤ 39 weeks, age 18 years or older and residency in the Netherlands. Exclusion criteria were multiple gestation, a history of a CS, planned IOL or CS in current pregnancy and GA > 39 weeks. A subgroup was formed of low risk (receiving primary care) nulliparous women with a gestational age between 34 and 39 weeks, comparable with the ARRIVE trial.
RESULTS


Three hundred eighty respondents participated. Of all respondents (nulli- and multiparous), 47 (12.4%) would be willing to participate in the hypothetical RCT and 70 (18.4%) might be willing to participate. Amongst the 70 women in the subgroup 11 women (15.7%) would be willing to participate and 17 (24.3%) might be willing to participate.
DISCUSSION AND CONCLUSION


Calculating sample size in a country with a low CS rate, in relation to 69.2% of women are not willing to participate in an RCT comparing IOL at 39 weeks with EM, would require >18.000 women to be counselled for participation. We believe such a study is a challenge in the Netherlands.",2022,"Of all respondents (nulli- and multiparous), 47 (12.4%) would be willing to participate in the hypothetical RCT and 70 (18.4%) might be willing to participate.","['Dutch low-risk pregnant women', 'low-risk nulliparous women with a gestational age (GA', 'Three hundred eighty respondents participated', 'A subgroup was formed of low risk (receiving primary care) nulliparous women with a gestational age between 34 and 39\xa0weeks, comparable with the ARRIVE trial', '39\xa0weeks, age 18\xa0years or older and residency in the Netherlands', '70 women in the subgroup 11 women (15.7%) would be willing to participate and 17 (24.3%) might be willing to participate', 'We conducted an online survey in 2020 in the Netherlands', 'Inclusion criteria were pregnant women with singleton gestation, GA\xa0≤', ""Pregnant women's willingness""]","['expectant management', 'expectant management (EM']","['rate of cesarean deliveries', 'caesarean sections (CS']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",380.0,0.126425,"Of all respondents (nulli- and multiparous), 47 (12.4%) would be willing to participate in the hypothetical RCT and 70 (18.4%) might be willing to participate.","[{'ForeName': 'Dorothée M R', 'Initials': 'DMR', 'LastName': 'Croll', 'Affiliation': ""Wilhelmina's Children Hospital, UMC Utrecht, Department of Obstetrics, Division Woman and Baby, Utrecht, the Netherlands. Electronic address: d.m.r.croll-2@umcutrecht.nl.""}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Meuleman', 'Affiliation': 'Radboud Medical Centre, Department of Obstetrics, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'de Heus', 'Affiliation': 'St. Antonius Hospital, Department of Gynecology & Obstetrics, Utrecht, the Netherlands.'}, {'ForeName': 'Marjon A', 'Initials': 'MA', 'LastName': 'de Boer', 'Affiliation': 'Amsterdam UMC Location Vrije Universiteit Amsterdam, Obstetrics and Gynaecology, Amsterdam, the Netherlands; Amsterdam Reproduction and Development Research Institute, Pregnancy and Birth, Amsterdam, the Netherlands.'}, {'ForeName': 'Corine J M', 'Initials': 'CJM', 'LastName': 'Verhoeven', 'Affiliation': 'Amsterdam UMC, Location VUmc, Midwifery Science, AVAG, APH Research Institute, Amsterdam, the Netherlands; Division of Midwifery, School of Health Sciences, University of Nottingham, United Kingdom; Maxima Medical Center, Department of Obstetrics and Gynecology, Veldhoven, the Netherlands.'}, {'ForeName': 'Kitty W M', 'Initials': 'KWM', 'LastName': 'Bloemenkamp', 'Affiliation': ""Wilhelmina's Children Hospital, UMC Utrecht, Department of Obstetrics, Division Woman and Baby, Utrecht, the Netherlands.""}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'van Dillen', 'Affiliation': 'Radboud Medical Centre, Department of Obstetrics, Nijmegen, the Netherlands.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2022.03.041']
816,35438014,"Acute high-intensity interval exercise versus moderate-intensity continuous exercise in heated water-based on hemodynamic, cardiac autonomic, and vascular responses in older individuals with hypertension.","OBJECTIVES


This crossover study design aimed to assess hemodynamic, cardiac autonomic, and vascular responses to high-intensity interval (HIIE) vs moderate-intensity continuous exercise (MICE) in older individuals with hypertension.
METHODS


Twenty (67 ± 7 y) older individuals with hypertension were randomly assigned to perform HIIE, MICE, or control (CON) sessions in the heated swimming pool (30-32°C). Blood pressure (BP), arterial stiffness, endothelial reactivity, and heart rate variability (HRV) were measured pre, post, and 45 min (recovery) after each intervention followed by 24-h ambulatory BP and HRV.
RESULTS


One single aerobic exercise session was not effective to provoke post-exercise hypotension and vascular improvements. HIIE was superior to MICE and CON to increasing parasympathetic modulation at post and recovery. Exercise sessions showed to disturb the autonomic system at nighttime compared to CON.
CONCLUSIONS


These results may have important implications in water-based therapy and the elderly with hypertension.",2022,"Exercise sessions showed to disturb the autonomic system at nighttime compared to CON.
","['Twenty', '67 ± 7 y) older individuals with hypertension', 'elderly with hypertension', 'older individuals with hypertension']","['Acute high-intensity interval exercise versus moderate-intensity continuous exercise', 'MICE and CON', 'aerobic exercise session', 'high-intensity interval (HIIE) vs moderate-intensity continuous exercise (MICE', 'HIIE, MICE, or control (CON) sessions in the heated swimming pool', 'Exercise sessions']","['hemodynamic, cardiac autonomic, and vascular responses', 'Blood pressure (BP), arterial stiffness, endothelial reactivity, and heart rate variability (HRV']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0039004', 'cui_str': 'Swimming pool'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0202461,"Exercise sessions showed to disturb the autonomic system at nighttime compared to CON.
","[{'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Roque Marçal', 'Affiliation': 'School of Sciences, Department of Physical Education, São Paulo State University (UNESP), Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, Brazil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teixeira Do Amaral', 'Affiliation': 'School of Sciences, Department of Physical Education, São Paulo State University (UNESP), Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, Brazil.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Fernandes', 'Affiliation': 'School of Sciences, Department of Physical Education, São Paulo State University (UNESP), Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, Brazil.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Martins de Abreu', 'Affiliation': 'Department of Physiotherapy, LUNEX International University of Health Exercise and Sports, Differdange, Luxembourg.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'School of Physical Therapy, Andres Bello University, Exercise and Rehabilitation Sciences Laboratory, Chile.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Veiga Guimarães', 'Affiliation': 'Heart Institute Department, University of São Paulo, School of Medicine, Heart Institute, São Paulo, Brazil.'}, {'ForeName': 'Véronique A', 'Initials': 'VA', 'LastName': 'Cornelissen', 'Affiliation': 'Leuven, University of Leuven, KU Leuven, Research Group for Cardiovascular RehabilitationDepartment of Rehabilitation Sciences, Belgium.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Gomes Ciolac', 'Affiliation': 'School of Sciences, Department of Physical Education, São Paulo State University (UNESP), Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2022.2065288']
817,35441849,Long-term mortality and health-related quality of life of lower versus higher oxygenation targets in ICU patients with severe hypoxaemia.,"PURPOSE


We assessed outcomes after 1 year of lower versus higher oxygenation targets in intensive care unit (ICU) patients with severe hypoxaemia.
METHODS


Pre-planned analyses evaluating 1-year mortality and health-related quality-of-life (HRQoL) outcomes in the previously published Handling Oxygenation Targets in the ICU trial which randomised 2928 adults with acute hypoxaemia to targets of arterial oxygen of 8 kPa or 12 kPa throughout the ICU stay up to 90 days. One-year all-cause mortality was assessed in the intention-to-treat population. HRQoL was assessed using EuroQol 5 dimensions 5 levels (EQ-5D-5L) questionnaire and EQ visual analogue scale score (EQ-VAS), and analyses were conducted in both survivors only and the intention-to-treat population with assignment of the worst scores to deceased patients.
RESULTS


We obtained 1-year vital status for 2887/2928 (98.6%), and HRQoL for 2600/2928 (88.8%) of the trial population. One year after randomisation, 707/1442 patients (49%) in the lower oxygenation group vs. 704/1445 (48.7%) in the higher oxygenation group had died (adjusted risk ratio 1.00; 95% confidence interval 0.93-1.08, p = 0.92). In total, 1189/1476 (80.4%) 1-year survivors participated in HRQoL interviews: median EQ-VAS scores were 65 (interquartile range 50-80) in the lower oxygenation group versus 67 (50-80) in the higher oxygenation group (p = 0.98). None of the five EQ-5D-5L dimensions differed between groups.
CONCLUSION


Among adult ICU patients with severe hypoxaemia, a lower oxygenation target (8 kPa) did not improve survival or HRQoL at 1 year as compared to a higher oxygenation target (12 kPa).",2022,"CONCLUSION


Among adult ICU patients with severe hypoxaemia, a lower oxygenation target (8 kPa) did not improve survival or HRQoL at 1 year as compared to a higher oxygenation target (12 kPa).","['ICU patients with severe hypoxaemia', '2928 adults with acute hypoxaemia to targets of arterial oxygen of 8\xa0kPa or 12\xa0kPa throughout the ICU stay up to 90\xa0days', 'intensive care unit (ICU) patients with severe hypoxaemia', 'adult ICU patients with severe hypoxaemia']",[],"['survival or HRQoL', '1-year mortality and health-related quality-of-life (HRQoL) outcomes', 'HRQoL', 'EuroQol 5 dimensions 5 levels (EQ-5D-5L) questionnaire and EQ visual analogue scale score (EQ-VAS', 'HRQoL interviews: median EQ-VAS scores']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2928.0,0.212229,"CONCLUSION


Among adult ICU patients with severe hypoxaemia, a lower oxygenation target (8 kPa) did not improve survival or HRQoL at 1 year as compared to a higher oxygenation target (12 kPa).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Crescioli', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Hobrovej 18-22, 9100, Aalborg, Denmark.'}, {'ForeName': 'Thomas Lass', 'Initials': 'TL', 'LastName': 'Klitgaard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Hobrovej 18-22, 9100, Aalborg, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Bjørn Anders', 'Initials': 'BA', 'LastName': 'Brand', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'Intensive Care Unit, Department of Acute Medicine and Department of Clinical Research, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thorbjørn', 'Initials': 'T', 'LastName': 'Grøfte', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Randers Hospital, Randers, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Keus', 'Affiliation': 'Department of Critical Care, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ulf Gøttrup', 'Initials': 'UG', 'LastName': 'Pedersen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Bäcklund', 'Affiliation': 'Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Karttunen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Department of Intensive Care, Cardiff University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Ciubotariu', 'Affiliation': 'Department of Anaesthesia and Intensive Care, North Denmark Region Hospital, Hjørring, Denmark.'}, {'ForeName': 'Anne-Marie Gellert', 'Initials': 'AG', 'LastName': 'Bunzel', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Hobrovej 18-22, 9100, Aalborg, Denmark.'}, {'ForeName': 'Stine Rom', 'Initials': 'SR', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Hobrovej 18-22, 9100, Aalborg, Denmark.'}, {'ForeName': 'Nicolaj Munch', 'Initials': 'NM', 'LastName': 'Jensen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Hobrovej 18-22, 9100, Aalborg, Denmark.'}, {'ForeName': 'Thomas Steen', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Maj-Brit Nørregaard', 'Initials': 'MN', 'LastName': 'Kjær', 'Affiliation': 'Centre for Research in Intensive Care, Copenhagen, Denmark.'}, {'ForeName': 'Aksel Karl Georg', 'Initials': 'AKG', 'LastName': 'Jensen', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': ', Hellerup, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Centre for Research in Intensive Care, Copenhagen, Denmark.'}, {'ForeName': 'Olav Lilleholt', 'Initials': 'OL', 'LastName': 'Schjørring', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Hobrovej 18-22, 9100, Aalborg, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Hobrovej 18-22, 9100, Aalborg, Denmark. bodil.steen.rasmussen@rn.dk.'}]",Intensive care medicine,['10.1007/s00134-022-06695-0']
818,35442613,"Combined Programmed Intermittent Bolus Infusion With Continuous Infusion for the Thoracic Paravertebral Block in Patients Undergoing Thoracoscopic Surgery: A Prospective, Randomized, and Double-blinded Study.","BACKGROUND


Continuous thoracic paravertebral block (TPVB) connected with patient-controlled analgesia (PCA) pump is an effective modality to reduce postoperative pain following thoracic surgery. For the PCA settings, the programmed intermittent bolus infusion (PIBI) and continuous infusion (CI) are commonly practiced. However, the comparative effectiveness between the 2 approaches has been inconsistent. Thus, the aim of this study was to explore the optimal PCA settings to treat postthoracotomy pain by combing PIBI and CI together.
METHODS


All enrolled patients undergoing thoracoscopic surgery accepted ultrasound-guided TPVB catheterization before the surgery and then were randomly allocated in to 3 groups depending on different settings of the PCA pump connecting to the TPVB catheter: the PIBI+CI, PIBI, and CI groups. Numerical Rating Scales were evaluated for each patient at T1 (1 h after extubation), T2 (12 h after the surgery), T3 (24 h after the surgery), T4 (36 h after the surgery), and T5 (48 h after the surgery). Besides, the consumptions of PCA ropivacaine, the number of blocked dermatomes at T3, and the requirement for extra dezocine for pain relief among the 3 groups were also compared.
RESULTS


First, the Numerical Rating Scale scores in the PIBI+CI group were lower than the CI group at T2 and T3 (P<0.05) when patients were at rest and were also lower than the CI group at T2, T3, and T4 (P<0.01) and the PIBI group at T3 when patients were coughing (P<0.01). Second, the 2-day cumulative dosage of PCA in the PIBI+CI group was lower than both the CI and PIBI groups (P<0.01). Third, the number of blocked dermatomes in the PIBI and PIBI+CI groups were comparable and were both wider than the CI group at T3 (P<0.01). Finally, a smaller proportion (not statistically significant) of patients in the PIBI+CI group (5.26%, 2/38) had required dezocine for pain relief when compared with the PIBI group (19.44%, 7/36) and the CI group (15.79%, 6/38).
CONCLUSIONS


The combination of PIBI and CI provides superior analgesic modality to either PIBI or CI alone in patients undergoing thoracoscopic surgery. Therefore, it should be advocated to improve the management of postoperative pain, clinical outcomes, and ultimately patient satisfaction.",2022,"Finally, a smaller proportion (not statistically significant) of patients in the PIBI + CI group (5.26%, 2/38) had required dezocine for pain relief when compared with the PIBI group (19.44%, 7/36) and the CI group (15.79%, 6/38).
","['Patients Undergoing Thoracoscopic Surgery', 'All enrolled patients undergoing', 'patients undergoing thoracoscopic surgery']","['PCA pump connecting to the TPVB catheter: the PIBI+CI, PIBI, and CI groups', 'thoracoscopic surgery accepted ultrasound guided TPVB catheterization', 'dezocine', 'Continuous thoracic paravertebral block (TPVB) connected with a patient-controlled analgesia (PCA) pump', 'analgesia (PCA) ropivacaine', 'PIBI or CI alone']","['postoperative pain', 'Numeric Rating Scales (NRS', 'NRS scores', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}]","[{'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0554314', 'cui_str': 'Blocked catheter'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0057626', 'cui_str': 'dezocine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",,0.142474,"Finally, a smaller proportion (not statistically significant) of patients in the PIBI + CI group (5.26%, 2/38) had required dezocine for pain relief when compared with the PIBI group (19.44%, 7/36) and the CI group (15.79%, 6/38).
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University.'}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University.'}, {'ForeName': 'Yangfan', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University.'}, {'ForeName': 'Junmei', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The Second Xiangya Hospital, Central South University.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000001037']
819,35443216,Laser activated irrigation with SWEEPS modality reduces concentration of sodium hypochlorite in root canal irrigation.,"INTRODUCTION


Shockwave enhanced emission photoacoustic streaming (SWEEPS) of Er: YAG laser has been proposed to improve the disinfecting efficacy of endodontic treatments. The purpose of this in vitro study was to compare the effects of different concentrations of sodium hypochlorite (NaOCl) combined with SWEEPS root canal irrigation on the removal of Enterococcus faecalis (E.faecalis) in infected bovine root canals.
MATERIALS AND METHODS


Forty-eight bovine root canals infected with E.faecalis were randomly divided into six groups. The root canals were irrigated by normal saline (NS) in combination with conventional needle irrigation (CI) , NS and different concentrations of NaOCl (0.5%, 1.0%, 2.0%, and 5.25%) in combination with SWEEPS. Then, the remaining live microbes from all specimens before and after root canal irrigation were collected and recovered via plate counting of the colony-forming unit (CFU). The CFU data were statistically analyzed by the Kruskal-Wallis H test.
RESULTS


After root canal irrigation, the viable count in each group was significantly reduced (P < 0.05). The bacterial reduction in NS+CI and NS+SWEEPS groups was significantly lower than that in other groups (P < 0.05), and there was no significant difference among the other groups, or between these two groups (P > 0.05).
CONCLUSIONS


This study showed that SWEEPS used for root canal irrigation can enhance the effect of low-concentration NaOCl while ensuring the antimicrobial effect.",2022,"After root canal irrigation, the viable count in each group was significantly reduced (P < 0.05).","['Root Canal Irrigation', 'infected bovine root canals', 'Forty-eight bovine root canals infected with E.faecalis']","['Laser Activated Irrigation with SWEEPS Modality', 'Shockwave enhanced emission photoacoustic streaming (SWEEPS) of Er', 'normal saline (NS) in combination with conventional needle irrigation (CI) , NS and different concentrations of NaOCl', 'sodium hypochlorite (NaOCl) combined with SWEEPS root canal irrigation', ' YAG laser', 'SWEEPS']","['viable count', 'bacterial reduction']","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}]","[{'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",48.0,0.0304596,"After root canal irrigation, the viable count in each group was significantly reduced (P < 0.05).","[{'ForeName': 'Lishan', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Lab of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Lab of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, Fuzhou, China; Stomatological Hospital of Xiamen Medical College, Xiamen, China.'}, {'ForeName': 'Yanhuang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Lab of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Lab of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Lab of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, Fuzhou, China. Electronic address: xiaojinghuang@fjmu.edu.cn.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2022.102873']
820,35443623,Contextual factors influencing advance care planning in home care: process evaluation of the cluster-randomised controlled trial STADPLAN.,"BACKGROUND


The STADPLAN study is a cluster-randomised controlled trial including 27 home care services in Germany. It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients. Patients received two ACP conversations and an information brochure. Nurses were educated through a two-day programme and topic guides structuring the conversations. Objectives of the process evaluation were to determine: [1] whether the intervention was implemented as planned, [2] which change mechanisms were observed, [3] whether targeted process outcomes were achieved and [4] in which way contextual factors influenced the implementation process.
METHODS


The process evaluation is based on a mixed methods approach following the recommendations of the UK-MRC framework for the development and evaluation of complex interventions. Qualitative and quantitative assessments were developed and analysed guided by a logic model comprising intervention, participants, mechanisms of change and context factors. The results of the main trial will be published elsewhere.
RESULTS


Educational programme and topic guides were mostly implemented as planned and resulted in motivation, knowledge, and perceived competencies to facilitate ACP conversations in nurses. Deviances in the performance of ACP conversations indicated patients' varied individual needs, but also obstacles like reluctance of patients and caregivers to participate actively and time constraints of nurse facilitators. Patients and caregivers reported increased awareness of ACP, planning and other activities indicating that targeted process outcomes could be achieved. The relevance of multifaceted contextual factors acting as barriers or facilitators for the engagement in ACP interventions on the individual, organisational and macro level was evident.
CONCLUSIONS


The process evaluation elicits obstacles and achievements of the ACP intervention. The logic model organised a plethora of mixed methods data into a holistic picture of multifaceted results. Nurses as ACP facilitators in home care can fulfil a crucial initiating role based on a trusting relationship with their patients. To support older care-dependent people's ACP engagement, access should be simplified. Furthermore, education for nurse facilitators and sufficient resources for service provision are needed. Independent of monetary reimbursement, healthcare providers must respect patients' choice for or against any ACP intervention.
ETHICS AND TRIAL REGISTRATION


Approved by the Ethics Committees of Martin Luther University Halle-Wittenberg (Ref.-No. 2019-045), Carl von Ossietzky University Oldenburg (Ref.-No. 2019-024), and University of Lübeck (Ref.-No. 19-080).
GERMAN CLINICAL TRIALS REGISTER


DRKS00016886. Registered retrospectively 04/06/2019, first participant included 29/05/2019.",2022,It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients.,"['Martin Luther University Halle-Wittenberg', 'home care', 'trained nurses to older care-dependent patients', '27 home care services in Germany', 'Carl von Ossietzky University Oldenburg ']","['advance care planning (ACP) intervention', 'ACP conversations and an information brochure']","['awareness of ACP, planning and other activities']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0702807,It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients.,"[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Silies', 'Affiliation': 'Nursing Research Unit, University of Lübeck, Institute for Social Medicine and Epidemiology, Ratzeburger Allee 160, 23562, Lübeck, Germany. Katharina.silies@uksh.de.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Huckle', 'Affiliation': 'Nursing Research Unit, University of Lübeck, Institute for Social Medicine and Epidemiology, Ratzeburger Allee 160, 23562, Lübeck, Germany.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Schnakenberg', 'Affiliation': 'Department for Health Services Research, Faculty of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Ammerländer Heerstraße 140, 26129, Oldenburg, Germany.'}, {'ForeName': 'Änne', 'Initials': 'Ä', 'LastName': 'Kirchner', 'Affiliation': 'Medical Faculty, Institute of Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Almuth', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Medical Faculty, Institute of Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Köberlein-Neu', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Rainer-Gruenter-Straße 21, 42119, Wuppertal, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'Medical Faculty, Institute of Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Hoffmann', 'Affiliation': 'Department for Health Services Research, Faculty of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Ammerländer Heerstraße 140, 26129, Oldenburg, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute of Nursing Science, University of Cologne, Faculty of Medicine and University Hospital Cologne, Gleueler Straße 176-178, 50935, Köln, Germany.'}]",BMC geriatrics,['10.1186/s12877-022-03026-2']
821,35444232,Adding bendamustine to melphalan before ASCT improves CR rate in myeloma vs. melphalan alone: A randomized phase-2 trial.,"Definite cure remains exceptional in myeloma patients even after high-dose chemotherapy (HDCT) with melphalan (Mel) and autologous stem cell transplantation (ASCT). Thus, improving efficacy of HDCT in MM remains an unresolved issue. This randomized phase II trial compared standard 200 mg/m 2  Mel HDCT to experimental HDCT with 200 mg/m 2  bendamustine, given both at days -4 and -3, combined with 100 mg/m 2  melphalan at days -2 and -1 (BenMel) before ASCT as first-line consolidation in myeloma patients. The primary endpoint aimed to identify at least a 15% improvement in the complete remission rate (stringent CR + CR) after HDCT with BenMel compared with Mel alone. A total of 120 MM patients were 1:1 randomized. The rate of sCR/CR after ASCT was higher in BenMel than in Mel treated patients (70.0% vs. 51.7%; p = 0.039). Three patients in the BenMel group (5.0%) had reversible acute renal insufficiency compared with none in Mel patients. Minimal residual disease negativity (<10-5) by flow cytometry was observed in 26 (45.6%) BenMel patients and 22 (37.9%) in the Mel group (p = 0.375). Our data suggest that BenMel HDCT is safe and improves the sCR/CR rate compared with standard Mel alone.",2022,Minimal residual disease negativity (<10-5) by flow cytometry was observed in 26 (45.6%),['A total of 120 MM patients'],"['standard 200\u2009mg/m 2  Mel HDCT to experimental HDCT with 200\u2009mg/m 2  bendamustine, given both at days -4 and -3, combined with 100\u2009mg/m 2  melphalan', 'chemotherapy (HDCT) with melphalan (Mel) and autologous stem cell transplantation (ASCT', 'HDCT', 'bendamustine to melphalan before ASCT']","['reversible acute renal insufficiency', 'sCR/CR rate', 'complete remission rate (stringent CR\u2009+\u2009CR', 'rate of sCR/CR after ASCT', 'Minimal residual disease negativity', 'CR rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]",,0.0366289,Minimal residual disease negativity (<10-5) by flow cytometry was observed in 26 (45.6%),"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Farag', 'Affiliation': 'Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bacher', 'Affiliation': 'Department of Hematology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Jeker', 'Affiliation': 'Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Legros', 'Affiliation': 'Department of Hematology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Rhyner', 'Affiliation': 'Department of Oncology, Cantonal Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Lüthi', 'Affiliation': 'Regional Hospital Thun, Thun, Switzerland.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Schardt', 'Affiliation': 'Bürgerspital Solothurn, Solothurn, Switzerland.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Zander', 'Affiliation': 'Cantonal Hospital Lucerne, Lucerne, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Hematology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Mansouri', 'Affiliation': 'Department of Hematology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Manz', 'Affiliation': 'ClinaMed, Therwil, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland. thomas.pabst@insel.ch.'}]",Bone marrow transplantation,['10.1038/s41409-022-01681-y']
822,35462581,Evaluation of double faced transverse preputial (onlay) island flap for hypospadias repair in pediatrics: a randomized controlled study.,"BACKGROUND


The preputial onlay island flap technique has been popularized for hypospadias repair as a result of offering a consistent combination of acceptable functional and cosmetic results. Like other techniques, urethrocutaneous fistulae and stricture continues to be the most common complications, in addition to other complications, which could be attributed to the compromise in flaps vascularity. Some authors describe a technique that resolves some of these problems by combining the unique benefits of the double faced preputial flaps.
THE AIM OF THIS STUDY


- to evaluate double faced preputial onlay island flap technique for complications rate, outcomes of surgical procedure, and cosmetic results in comparison to transverse inner preputial flap technique.
PATIENTS AND METHODS


This was a prospective randomized controlled study that included 68 patients with anterior, mid-penile, and posterior penile hypospadias, with shallow and narrow urethral plate of size less than 6 mm, who underwent single-stage repair using preputial flaps, conducted at the department of pediatric surgery (Al-Azhar University, Cairo, Egypt), between May 2019 and October 2021, to evaluate double faced transverse preputial onlay island flap technique. Thirty-four patients underwent double faced transverse preputial onlay island flap (group A) and another 34 patients underwent inner transverse preputial onlay island flap (control group) (group B). The follow-up period ranged from 12 to 26 months.
RESULTS


The overall complication rate was 20.5% (14 of 68 children). Complications developed in 5 cases (14.7%) in group A who underwent double face onlay island flap (2 glannular dehiscence, 1 penile rotation, 1 fistula, and 1 diverticulum), as opposed to 9 patients in group B (26.4%) who underwent transverse inner preputial flap (3 developed glannular dehiscence, 2 skin flap necrosis, 3 fistulae, and 1 diverticulum). After management of the complications, all patients had good surgical outcomes with satisfactory cosmetic results.
CONCLUSION


Double faced transverse preputial onlay island flap is an alternative option to reconstruct narrow urethral plate hypospadias. So that double faced transverse preputial onlay island flap technique appears to achieve satisfactory surgical outcomes with lower complication rate.",2022,"Complications developed in 5 cases (14.7%) in group A who underwent double face onlay island flap (2 glannular dehiscence, 1 penile rotation, 1 fistula, and 1 diverticulum), as opposed to 9 patients in group B (26.4%) who underwent transverse inner preputial flap (3 developed glannular dehiscence, 2 skin flap necrosis, 3 fistulae, and 1 diverticulum).","['hypospadias repair in pediatrics', '68 patients with anterior, mid-penile, and posterior penile hypospadias, with shallow and narrow urethral plate of size less than 6\xa0mm, who underwent single-stage repair using preputial flaps, conducted at the department of pediatric surgery (Al-Azhar University, Cairo, Egypt), between May 2019 and October 2021, to evaluate double faced transverse preputial onlay island flap technique']","['transverse inner preputial flap', 'Double faced transverse preputial onlay island flap', 'double faced transverse preputial (onlay) island flap', 'double faced transverse preputial onlay island flap (group A) and another 34 patients underwent inner transverse preputial onlay island flap (control group']","['Complications', 'overall complication rate']","[{'cui': 'C0558337', 'cui_str': 'Hypospadias repair'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1691215', 'cui_str': 'Hypospadias, penile'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0440785', 'cui_str': 'Urethral plate'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0851249', 'cui_str': 'Island Flaps'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0851249', 'cui_str': 'Island Flaps'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",68.0,0.0979431,"Complications developed in 5 cases (14.7%) in group A who underwent double face onlay island flap (2 glannular dehiscence, 1 penile rotation, 1 fistula, and 1 diverticulum), as opposed to 9 patients in group B (26.4%) who underwent transverse inner preputial flap (3 developed glannular dehiscence, 2 skin flap necrosis, 3 fistulae, and 1 diverticulum).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Daboos', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt. daboosmohammad@gmail.com.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Hefney', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdelhafez Mahmoud', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Salama', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Mohammed', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelmaboud', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt.'}, {'ForeName': 'Tharwat', 'Initials': 'T', 'LastName': 'Hussein', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Ashour', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gouda', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt.'}]",International urology and nephrology,['10.1007/s11255-022-03217-1']
823,35462552,"Immune microenvironment, homologous recombination deficiency, and therapeutic response to neoadjuvant chemotherapy in triple-negative breast cancer: Japan Breast Cancer Research Group (JBCRG)22 TR.","BACKGROUND


Triple-negative breast cancer (TNBC) is a biologically diverse disease, with characteristics such as homologous recombination deficiency (HRD), gene mutation, and immune reactions. Japan Breast Cancer Research Group 22 is a multicenter trial examining TNBC's response to neoadjuvant chemotherapy (NAC) according to the HRD status. This translational research investigated the clinical significance of the immune microenvironment of TNBC in association with HRD, tumor BRCA1/2 (tBRCA1/2) mutation, and response to NAC.
METHODS


Patients aged below 65 years with high HRD or germline BRCA1/2 (gBRCA1/2) mutation randomly received paclitaxel + carboplatin (group A1) or eribulin + carboplatin (A2), followed by anthracycline. Patients aged below 65 years with low HRD or those aged 65 years or older without gBRCA1/2 mutation randomly received eribulin + cyclophosphamide (B1) or eribulin + capecitabine (B2); nonresponders to the first four cycles of the therapy received anthracycline. A pathological complete response (pCR) was defined as the absence of residual cancer cells in the tissues. Pretreatment biopsy specimens were stained by multiplexed fluorescent immunohistochemistry using antibodies against CD3, CD4, CD8, Foxp3, CD204, and pan-cytokeratin. Immune cells with specific phenotypes were counted per mm 2  in cancer cell nests (intratumor) and stromal regions. The immune cell densities were compared with clinicopathological and genetic factors including tumor response.
RESULTS


This study analyzed 66 samples. T1 tumors had a significantly higher density of intratumoral CD8 +  T cells than T2 or larger tumors. The tBRCA1/2 mutation or HRD status was not associated with the density of any immune cell. The density of intratumoral and stromal CD4 +  T cells was higher in patients showing pCR than in those without pCR. In a multivariate analysis, intratumoral and stromal CD4 +  T cell density significantly predicted pCR independent of age, chemotherapy dose, HRD status, and treatment groups (P = 0.009 and 0.0057, respectively). In a subgroup analysis, the predictive value of intratumoral and stromal CD4 +  T cell density persisted in the platinum-containing chemotherapy group (A1+A2) but not in the non-platinum-containing group (B1+B2).
CONCLUSIONS


Intratumoral and stromal CD4 +  T cell density was an independent predictor of pCR in patients with TNBC. A larger study is warranted to confirm the results.
TRIAL REGISTRATION


UMIN000023162.",2022,T1 tumors had a significantly higher density of intratumoral CD8 +  T cells than T2 or larger tumors.,"['patients with TNBC', 'Patients aged below 65 years with high HRD or germline BRCA1/2 (gBRCA1/2) mutation randomly received', 'Patients aged below 65 years with low HRD or those aged 65 years or older without gBRCA1/2 mutation randomly received']","['neoadjuvant chemotherapy', 'paclitaxel + carboplatin (group A1) or eribulin + carboplatin (A2), followed by anthracycline', 'anthracycline', 'neoadjuvant chemotherapy (NAC', 'eribulin + cyclophosphamide (B1) or eribulin + capecitabine (B2']","['predictive value of intratumoral and stromal CD4 +  T cell density', 'density of intratumoral CD8 +  T cells', 'density of intratumoral and stromal CD4 +  T cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}]",,0.0933239,T1 tumors had a significantly higher density of intratumoral CD8 +  T cells than T2 or larger tumors.,"[{'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Breast Surgical Oncology, The Cancer Institute Hospital of JFCR, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan. takayuki.ueno@jfcr.or.jp.'}, {'ForeName': 'Shigehisa', 'Initials': 'S', 'LastName': 'Kitano', 'Affiliation': 'Division of Cancer Immunotherapy Development, Advanced Medical Development Center, The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Ikarashi', 'Affiliation': 'Division of Cancer Immunotherapy Development, Advanced Medical Development Center, The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Yamashita', 'Affiliation': 'Division of Cancer Immunotherapy Development, Advanced Medical Development Center, The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Chiba', 'Affiliation': 'Division of Pathology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kadoya', 'Affiliation': 'Department of Breast Surgery, Hiroshima University Hospital, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Ohtani', 'Affiliation': 'Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Division of Breast Oncology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osako, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Breast Surgery, NHO Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Department of Medical Oncology, Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Aogi', 'Affiliation': 'Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Velaga', 'Affiliation': 'Department of Breast Surgery, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Breast Surgery, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Haga', 'Affiliation': 'Department of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Breast Oncology Center, The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Department of Breast Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}]",BMC medicine,['10.1186/s12916-022-02332-1']
824,35467955,"Letter by Natale et al Regarding Article, ""Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial"".",,2022,,['Stroke Prophylaxis (Amulet IDE'],['Occluder Versus Watchman Device'],['Amplatzer Amulet Left Atrial Appendage'],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0328104', 'cui_str': 'Leuciscus idus'}]","[{'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}]",,0.159711,,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natale', 'Affiliation': 'Texas Cardiac Arrythmia Institute, Austin, TX (A.N.).'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Los Robles Regional Medical Center, Thousand Oaks, CA (S.K.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holmes', 'Affiliation': 'Mayo Clinic, Rochester, MN (D.H.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057567']
825,35467951,"Letter by Price et al Regarding the Article, ""Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial"".",,2022,,['Stroke Prophylaxis (Amulet IDE'],['Occluder Versus Watchman Device'],['Amplatzer Amulet Left Atrial Appendage'],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0328104', 'cui_str': 'Leuciscus idus'}]","[{'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}]",,0.162973,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Price', 'Affiliation': 'Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA (M.J.P., D.NG.).'}, {'ForeName': 'Doug N', 'Initials': 'DN', 'LastName': 'Gibson', 'Affiliation': 'Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA (M.J.P., D.NG.).'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Los Robles Regional Medical Center, Thousand Oaks, CA (S.K.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.058485']
826,35467950,"Letter by Dhruva and Redberg Regarding Article, ""Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial"".",,2022,,['Stroke Prophylaxis (Amulet IDE'],['Occluder Versus Watchman Device'],['Amplatzer Amulet Left Atrial Appendage'],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0328104', 'cui_str': 'Leuciscus idus'}]","[{'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}]",,0.172412,,"[{'ForeName': 'Sanket S', 'Initials': 'SS', 'LastName': 'Dhruva', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies (S.S.D., R.F.R.).'}, {'ForeName': 'Rita F', 'Initials': 'RF', 'LastName': 'Redberg', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies (S.S.D., R.F.R.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057472']
827,35468330,Is contralateral autogenous patellar tendon graft a better choice than ipsilateral for anterior cruciate ligament reconstruction in young sportsmen? A randomized controlled trial.,"AIM


The aim of this study was to compare the peak extensor torque (primary outcome), sensory-motor capacity and Lysholm questionnaire score up to the fourth postoperative month post-primary anterior cruciate ligament reconstruction (ACLR) with bone-patellar-tendon-bone (BPTB) graft using either ipsilateral or contralateral technique in young sportsmen.
METHODS


We performed a randomized controlled trial from 2018 to 2019. The same preoperative protocol, surgical technique and postoperative protocol were used in both groups. Eighty-eight young adult male patients were randomized, and 44 of each group completed the trial.
RESULTS


After the follow up analysis, the contralateral receptor and donor limb demonstrated a statistically significant increase in peak extension torque compared with the ipsilateral operated limb (effect size (ES) = 0.99, power = 0.99, P < 0.0001; ES = 0.46, power = 0.56, P < 0.04). The symmetry between limbs was compared between groups. In the contralateral group, there was a significant decrease in the recipient limb (after surgery), compared with the donor limb (before surgery) (ES = 0.87, power = 0.99, P < 0.0001). In the ipsilateral group, the operated limb demonstrated a significant decrease in peak extension torque compared with the non-operated limb after surgery (ES = 1.88, power = 0.99, P < 0.0001). The comparison between groups in sensory-motor capacity and Lysholm score demonstrated a non-significant group effect postoperatively.
CONCLUSION


The use of contralateral BPTB is more effective in increasing peak extension torque when compared with ipsilateral technique in young sportsmen. Furthermore, patients achieved greater symmetry (side to side) in quadriceps muscle performance after the 4-month follow up with a contralateral graft.",2022,"In the ipsilateral group, the operated limb demonstrated a significant decrease in peak extension torque compared with the non-operated limb after surgery (ES = ","['young sportsmen', '2018 to 2019', 'Eighty-eight young adult male patients']","['contralateral BPTB', 'fourth postoperative month post-primary anterior cruciate ligament reconstruction (ACLR) with bone-patellar-tendon-bone (BPTB) graft using either ipsilateral or contralateral technique', 'contralateral autogenous patellar tendon graft']","['quadriceps muscle performance', 'peak extensor torque (primary outcome), sensory-motor capacity and Lysholm questionnaire score', 'recipient limb', 'sensory-motor capacity and Lysholm score', 'peak extension torque']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0349678', 'cui_str': 'Sportsman'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0449871', 'cui_str': 'Use of graft'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",88.0,0.0546331,"In the ipsilateral group, the operated limb demonstrated a significant decrease in peak extension torque compared with the non-operated limb after surgery (ES = ","[{'ForeName': 'Jose Humberto', 'Initials': 'JH', 'LastName': 'de Souza Borges', 'Affiliation': 'Institute of Research and Teaching, Orthopedic Hospital and Specialized Medicine (IPE - H O M E), Brasília, Distrito Federal, Brazil; Department of Orthopedics, Traumatology and Sports Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil. Electronic address: drjhumberto@gmail.com.'}, {'ForeName': 'Marcio', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': 'Institute of Research and Teaching, Orthopedic Hospital and Specialized Medicine (IPE - H O M E), Brasília, Distrito Federal, Brazil; University Center of Brasília (UniCEUB), Brasília, Distrito Federal, Brazil.'}, {'ForeName': 'Paulo Lobo', 'Initials': 'PL', 'LastName': 'Junior', 'Affiliation': 'Institute of Research and Teaching, Orthopedic Hospital and Specialized Medicine (IPE - H O M E), Brasília, Distrito Federal, Brazil.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'de Souza Machado', 'Affiliation': 'Institute of Research and Teaching, Orthopedic Hospital and Specialized Medicine (IPE - H O M E), Brasília, Distrito Federal, Brazil.'}, {'ForeName': 'Révia', 'Initials': 'R', 'LastName': 'Lima', 'Affiliation': 'Institute of Research and Teaching, Orthopedic Hospital and Specialized Medicine (IPE - H O M E), Brasília, Distrito Federal, Brazil.'}, {'ForeName': 'Leonardo Addêo', 'Initials': 'LA', 'LastName': 'Ramos', 'Affiliation': 'Department of Orthopedics, Traumatology and Sports Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Department of Orthopedics, Traumatology and Sports Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil.'}]",The Knee,['10.1016/j.knee.2022.03.015']
828,35468325,"Effect of tirzepatide versus insulin degludec on liver fat content and abdominal adipose tissue in people with type 2 diabetes (SURPASS-3 MRI): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial.","BACKGROUND


Tirzepatide is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 receptor agonist under development for the treatment of type 2 diabetes. The aim of this substudy was to characterise the changes in liver fat content (LFC), volume of visceral adipose tissue (VAT), and abdominal subcutaneous adipose tissue (ASAT) in response to tirzepatide or insulin degludec in a subpopulation of the SURPASS-3 study.
METHODS


This substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial was done at 45 medical research centres and hospitals across eight countries (Argentina, Austria, Greece, Hungary, Italy, Romania, Spain, and the USA). Eligible participants were adults with type 2 diabetes, a baseline HbA 1c  7·0-10·5% (53-91 mmol/mol), a BMI of at least 25 kg/m 2 , stable weight, were insulin-naive, and on treatment with metformin alone or in combination with a SGLT2 inhibitor for at least 3 months before screening. In addition to the main study inclusion criteria, substudy participants had a fatty liver index of at least 60. Participants had an MRI scan and were randomised (1:1:1:1) in the main study to subcutaneous injection once per week of tirzepatide 5 mg, 10 mg, or 15 mg, or subcutaneous injection once per day of titrated insulin degludec, using an interactive web-response system, and were stratified by country, HbA 1c , and concomitant oral anti-hyperglycaemic medication. The primary efficacy endpoint was the change from baseline in LFC (as measured by MRI-proton density fat fraction [MRI-PDFF]) at week 52 using pooled data from the tirzepatide 10 mg and 15 mg groups versus insulin degludec. Analyses were assessed in the enrolled MRI population, which consisted of participants in the modified intention-to-treat population of the main study who also had a valid MRI at either baseline or after baseline. This is a substudy of the trial registered with ClinicalTrials.gov, number NCT03882970, and is complete.
FINDINGS


From April 1, 2019, to Nov 15, 2019, 502 participants were assessed for eligibility to participate in this substudy, 296 (59%) of whom were included in the enrolled MRI population and randomly assigned to treatment (tirzepatide 5 mg, n=71; tirzepatide 10 mg, n=79; tirzepatide 15 mg, n=72; and insulin degludec, n=74). Baseline demographics and clinical characteristics were similar across all treatment groups. From an overall mean baseline LFC of 15·71% (SD 8·93), the absolute reduction in LFC at week 52 was significantly greater for the pooled tirzepatide 10 mg and 15 mg groups (-8·09%, SE 0·57) versus the insulin degludec group (-3·38%, 0·83). The estimated treatment difference versus insulin degludec was -4·71% (95% CI -6·72 to -2·70; p<0·0001). The reduction in LFC was significantly correlated (p≤0·0006) with baseline LFC (ρ=-0·71), reductions in VAT (ρ=0·29), reductions in ASAT (ρ=0·33), and reductions in body weight (ρ=0·34) in the tirzepatide groups.
INTERPRETATION


Tirzepatide showed a significant reduction in LFC and VAT and ASAT volumes compared with insulin degludec in this subpopulation of patients with type 2 diabetes in the SURPASS-3 study. These data provide additional evidence on the metabolic effects of this novel dual GIP and GLP-1 receptor agonist.
FUNDING


Eli Lilly and Company.",2022,"The reduction in LFC was significantly correlated (p≤0·0006) with baseline LFC (ρ=-0·71), reductions in VAT (ρ=0·29), reductions in ASAT (ρ=0·33), and reductions in body weight (ρ=0·34) in the tirzepatide groups.
","['people with type 2 diabetes (SURPASS-3 MRI', 'enrolled MRI population, which consisted of participants in the modified intention-to-treat population of the main study who also had a valid MRI at either baseline or after baseline', 'substudy participants had a fatty liver index of at least 60', 'From April 1, 2019, to Nov 15, 2019, 502 participants were assessed for eligibility to participate in this substudy, 296 (59%) of whom were included in the enrolled MRI population', 'Participants had an MRI scan', '45 medical research centres and hospitals across eight countries (Argentina, Austria, Greece, Hungary, Italy, Romania, Spain, and the USA', 'Eligible participants were adults with type 2 diabetes, a baseline HbA 1c  7·0']","['tirzepatide versus insulin degludec', 'tirzepatide', 'tirzepatide 10 mg, n=79; tirzepatide', 'metformin alone or in combination with a SGLT2 inhibitor']","['reduction in LFC', 'change from baseline in LFC (as measured by MRI-proton density fat fraction [MRI-PDFF', 'liver fat content (LFC), volume of visceral adipose tissue (VAT), and abdominal subcutaneous adipose tissue (ASAT', 'liver fat content and abdominal adipose tissue', 'reductions in VAT (ρ=0·29), reductions in ASAT (ρ=0·33), and reductions in body weight', 'absolute reduction in LFC', 'LFC and VAT and ASAT volumes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C4761214', 'cui_str': 'Magnetic resonance proton density fat fraction measurement'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1563741', 'cui_str': 'Fat, Abdominal Subcutaneous'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",502.0,0.395069,"The reduction in LFC was significantly correlated (p≤0·0006) with baseline LFC (ρ=-0·71), reductions in VAT (ρ=0·29), reductions in ASAT (ρ=0·33), and reductions in body weight (ρ=0·34) in the tirzepatide groups.
","[{'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Cusi', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, The University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fernández Landó', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Bray', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Brouwers', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Rodríguez', 'Affiliation': 'and Lilly Spain, Madrid, Spain. Electronic address: rodriguez_angel@lilly.com.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(22)00070-5']
829,35468322,"Effects of subcutaneous tirzepatide versus placebo or semaglutide on pancreatic islet function and insulin sensitivity in adults with type 2 diabetes: a multicentre, randomised, double-blind, parallel-arm, phase 1 clinical trial.","BACKGROUND


Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, shows a remarkable ability to lower blood glucose, enabling many patients with long-standing type 2 diabetes to achieve normoglycaemia. We aimed to understand the physiological mechanisms underlying the action of tirzepatide in type 2 diabetes.
METHODS


This multicentre, randomised, double-blind, parallel-arm, phase 1 study was done at two centres in Germany. Eligible patients were aged 20-74 years, had type 2 diabetes for at least 6 months, and were being treated with lifestyle advice and stable doses of metformin, with or without one additional stable dose of another oral antihyperglycaemic medicine, 3 months before study entry. Via a randomisation table, patients were randomly assigned (3:3:2) to subcutaneously receive either tirzepatide 15 mg, semaglutide 1 mg, or placebo once per week. Endpoint measurements were done at baseline and the last week of therapy (week 28). The primary endpoint was the effect of tirzepatide versus placebo on the change in clamp disposition index (combining measures of insulin secretion and sensitivity) from baseline to week 28 of treatment and was analysed in the pharmacodynamic analysis set, which comprised all randomly assigned participants who received at least one dose of a study drug and had evaluable pharmacodynamic data. Safety was analysed in the safety population, which comprised all randomly assigned participants who received at least one dose of a study drug. Secondary endpoints included the effect of tirzepatide versus semaglutide on the change in clamp disposition index from baseline to week 28 of treatment, glucose control, total insulin secretion rate, M value (insulin sensitivity), and fasting and postprandial glucagon concentrations. Exploratory endpoints included the change in fasting and postprandial insulin concentrations. This study is registered with ClinicalTrials.gov, NCT03951753, and is complete.
FINDINGS


Between June 28, 2019, and April 8, 2021, we screened 184 individuals and enrolled 117 participants, all of whom were included in the safety population (45 in the tirzepatide 15 mg group, 44 in the semaglutide 1 mg group, and 28 in the placebo group). Because of discontinuations and exclusions due to missing or unevaluable data, 39 patients in each treatment group and 24 patients in the placebo group comprised the pharmacodynamic analysis set. With tirzepatide, the clamp disposition index increased from a least squares mean of 0·3 pmol m -2  L min -2  kg -1  (SE 0·03) at baseline by 1·9 pmol m -2  L min -2  kg -1  (0·16) to total 2·3 pmol m -2  L min -2  kg -1  (SE 0·16) at week 28 and, with placebo, the clamp disposition index did not change much from baseline (least squares mean at baseline 0·4 pmol m -2  L min -2  kg -1  [SE 0·04]; change from baseline 0·0 pmol m -2  L min -2  kg -1  [0·03]; least squares mean at week 28 0·3 [SE 0·03]; estimated treatment difference [ETD] tirzepatide vs placebo 1·92 [95% CI 1·59-2·24]; p<0·0001). The improvement with tirzepatide in clamp disposition index was significantly greater than with semaglutide (ETD 0·84 pmol m -2  L min -2  kg -1  [95% CI 0·46-1·21]). This result reflected significant improvements in total insulin secretion rate (ETD 102·09 pmol min -1  m -2  [51·84-152·33]) and insulin sensitivity (ETD 1·52 mg min -1  kg -1  [0·53-2·52]) for tirzepatide versus semaglutide. On meal tolerance testing, tirzepatide significantly reduced glucose excursions (lower insulin and glucagon concentrations) compared with placebo, with effects on these variables being greater than with semaglutide. The safety profiles of tirzepatide and semaglutide were similar, with gastrointestinal adverse events being the most common (11 [24%], 13 [30%], and seven [25%] with nausea; nine [20%], 13 [30%], and six [21%] with diarrhoea; and three [7%], five [11%], and one [4%] with vomiting, for tirzepatide, semaglutide, and placebo, respectively). There were no deaths.
INTERPRETATION


The glycaemic efficacy of GIP/GLP-1 receptor agonist tirzepatide in type 2 diabetes results from concurrent improvements in key components of diabetes pathophysiology, namely β-cell function, insulin sensitivity, and glucagon secretion. These effects were large and help to explain the remarkable glucose-lowering ability of tirzepatide seen in phase 3 studies.
FUNDING


Eli Lilly.",2022,"On meal tolerance testing, tirzepatide significantly reduced glucose excursions (lower insulin and glucagon concentrations) compared with placebo, with effects on these variables being greater than with semaglutide.","['Eligible patients were aged 20-74 years, had type 2 diabetes for at least 6 months, and were being treated with lifestyle advice and stable doses of metformin, with or without one additional stable dose of another oral antihyperglycaemic medicine, 3 months before study entry', 'Between June 28, 2019, and April 8, 2021, we screened 184 individuals and enrolled 117 participants, all of whom were included in the safety population (45 in the tirzepatide 15 mg group, 44 in the semaglutide 1 mg group, and 28 in the placebo group', 'two centres in Germany', 'adults with type 2 diabetes']","['tirzepatide 15 mg, semaglutide 1 mg, or placebo', 'GIP/GLP-1 receptor agonist tirzepatide', 'tirzepatide versus placebo', 'placebo', 'semaglutide (ETD 0·84 pmol m', 'tirzepatide', 'subcutaneous tirzepatide versus placebo or semaglutide']","['insulin sensitivity', 'pancreatic islet function and insulin sensitivity', 'diabetes pathophysiology, namely β-cell function, insulin sensitivity, and glucagon secretion', 'clamp disposition index', 'tirzepatide in clamp disposition index', 'total insulin secretion rate', 'clamp disposition index (combining measures of insulin secretion and sensitivity', 'glucose excursions (lower insulin and glucagon concentrations', 'change in fasting and postprandial insulin concentrations', 'effect of tirzepatide versus semaglutide on the change in clamp disposition index from baseline to week 28 of treatment, glucose control, total insulin secretion rate, M value (insulin sensitivity), and fasting and postprandial glucagon concentrations', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0022131', 'cui_str': 'Endocrine pancreatic structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0861023', 'cui_str': 'Insulin low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",117.0,0.690275,"On meal tolerance testing, tirzepatide significantly reduced glucose excursions (lower insulin and glucagon concentrations) compared with placebo, with effects on these variables being greater than with semaglutide.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mari', 'Affiliation': 'Institute of Neuroscience, National Research Council, Padova, Italy.'}, {'ForeName': 'J Hans', 'Initials': 'JH', 'LastName': 'DeVries', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Urva', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Edward John', 'Initials': 'EJ', 'LastName': 'Pratt', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Coskun', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Thomas', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haupt', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Zvonko', 'Initials': 'Z', 'LastName': 'Milicevic', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA. Electronic address: milicevic_zvonko@lilly.com.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(22)00085-7']
830,35468321,"Efficacy of once-weekly tirzepatide versus once-daily insulin degludec on glycaemic control measured by continuous glucose monitoring in adults with type 2 diabetes (SURPASS-3 CGM): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial.","BACKGROUND


Tirzepatide is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist under development for the treatment of type 2 diabetes. In this study, we used continuous glucose monitoring (CGM) to compare the 24 h glucose profile for participants given tirzepatide compared with those given insulin degludec.
METHODS


This substudy of the open-label, parallel-group, phase 3 SURPASS-3 trial, was done at 45 sites across six countries (Hungary, Poland, Romania, Spain, Ukraine, and the USA). Eligible participants in the main study were adults with type 2 diabetes, a baseline HbA 1c  of 7·0-10·5% (53-91 mmol/mol), and a BMI of 25 kg/m 2  or more, who were insulin-naive, and treated with metformin alone or in combination with a SGLT2 inhibitor for at least 3 months before screening. Participants in the main study were randomly assigned (1:1:1:1) to receive once-weekly subcutaneous injection of tirzepatide 5 mg, 10 mg, or 15 mg, or once-daily subcutaneous injection of titrated insulin degludec (100 U/mL), using an interactive web-response system. Participants were stratified by country, HbA 1c  concentration, and concomitant oral antihyperglycaemic medication. A subset of these patients with a normal wake-sleep cycle were enrolled into this substudy, and interstitial glucose values were collected by CGM for approximately 7 days at baseline, 24 weeks, and 52 weeks. The primary outcome was to compare pooled participants assigned to 10 mg and 15 mg tirzepatide versus insulin degludec for the proportion of time that CGM values were in the tight target range (71-140 mg/dL) at 52 weeks, assessed in all randomly assigned participants who received at least one dose of study drug and had an evaluable CGM session at either baseline or after baseline. The secondary outcomes were to compare tirzepatide (5 mg, 10 mg, and 15 mg) versus insulin degludec for the proportion and duration of time in tight target range at 24 and 52 weeks. This was a substudy of the trial registered with ClinicalTrials.gov, NCT03882970, and is complete.
FINDINGS


From April 1 to Nov 27, 2019, 313 participants were screened for eligibility, 243 of whom were enrolled in CGM substudy (tirzepatide 5 mg, n=64; tirzepatide 10 mg, n=51; tirzepatide 15 mg, n=73; and insulin degludec, n=55). Patients given once-weekly tirzepatide (pooled 10 mg and 15 mg groups) had a greater proportion of time in tight target range compared with patients given insulin degludec (estimated treatment difference 25% [95% CI 16-33]; p<0·0001). Participants assigned to tirzepatide spent significantly more time in tight target range at 52 weeks compared with those assigned to insulin degludec (5 mg 12% [1-22], p=0·031; 10 mg 24% [13-35], p<0·0001; and 15 mg 25% [14-35], p<0·0001). Participants assigned to tirzepatide 10 mg and 15 mg, but not to tirzepatide 5 mg, spent significantly more time in tight target range at 24 weeks compared with insulin degludec (10 mg 19% [8-30], p=0·0008; 15 mg 21% [11-31], p<0·0001).
INTERPRETATION


Once-weekly treatment with tirzepatide showed superior glycaemic control measured using CGM compared with insulin degludec in participants with type 2 diabetes on metformin, with or without a SGLT2 inhibitor. These new data provide additional evidence to the effect of tirzepatide and potential for achieving glycaemic targets without increase of hypoglycaemic risk compared with a basal insulin.
FUNDING


Eli Lilly and Company.",2022,"Participants assigned to tirzepatide spent significantly more time in tight target range at 52 weeks compared with those assigned to insulin degludec (5 mg 12% [1-22], p=0·031; 10 mg 24% [13-35], p<0·0001; and 15 mg 25% [14-35], p<0·0001).","['Eligible participants in the main study were adults with type 2 diabetes, a baseline HbA 1c  of 7·0-10·5% (53-91 mmol/mol), and a BMI of 25 kg/m 2  or more, who were insulin-naive, and treated with', 'From April 1 to Nov 27, 2019, 313 participants were screened for eligibility, 243 of whom were enrolled in CGM substudy (tirzepatide 5 mg, n=64', 'participants with type 2 diabetes on', 'participants given tirzepatide compared with those given insulin degludec', 'adults with type 2 diabetes (SURPASS-3 CGM', 'for at least 3 months before screening', 'patients with a normal wake-sleep cycle']","['continuous glucose monitoring (CGM', 'metformin alone or in combination with a SGLT2 inhibitor', 'tirzepatide versus once-daily insulin degludec', 'tirzepatide 10 mg, n=51; tirzepatide', 'metformin', 'tirzepatide']","['insulin degludec for the proportion and duration of time in tight target range', 'time in tight target range', 'glycaemic control', 'proportion of time that CGM values', 'proportion of time in tight target range', 'hypoglycaemic risk']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",313.0,0.166085,"Participants assigned to tirzepatide spent significantly more time in tight target range at 52 weeks compared with those assigned to insulin degludec (5 mg 12% [1-22], p=0·031; 10 mg 24% [13-35], p<0·0001; and 15 mg 25% [14-35], p<0·0001).","[{'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': 'Faculty of Medicine, University of Ljubljana, and University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center Health Partners Institute, Minneapolis, MN, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Rodríguez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fernández Landó', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Bray', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. Electronic address: katelyn.brown@lilly.com.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(22)00077-8']
831,35435053,Mental Fatigue Prior to Aerobic Exercise Reduces Exercise Pleasure and Negatively Affects Implicit Attitudes Toward Future Exercise.,"We investigated the effects of mental fatigue (MF) on affective responses during an aerobic exercise session at moderate intensity. We submitted 12 insufficiently active adults (50% women;  M  age = 24.9 years,  SD  = 3.0;  M  BMI = 24.3 kg/m 2 ;  SD  = 2.6) to two 30-minute pre-exercise conditions: an MF condition (Stroop Color-Word task) and a control condition (watching a documentary) prior to their performance of 20 minutes of aerobic treadmill exercise at 40-59% of heart rate reserve. The minimum washout interval between conditions was two days. Perceived MF and motivation to perform physical exercise were assessed before and after conditions with a visual analog scale of 100 mm. We assessed participants' affective and exertion responses with the Feeling Scale, Rating of Perceived Exertion (RPE) and heart rate during every two minutes of physical exercise. Implicit attitudes toward physical exercise were assessed by the Implicit Association Test before the MF and control conditions and after the physical exercise session. The participants in the MF condition reported lower pleasure ( M  difference = -1.57, 95% CI = -2.64 to -0.50, d = 0.93,  p  = .008) and higher exertion (RPE) ( M  difference = 1.16, 95% CI = 0.04 to 2.27, d = 0.66,  p  = .043) compared to those in the control condition. Participants who experienced MF also reported a more negative implicit attitude toward physical exercise than in the control condition ( β  = -0.47, 95% CI= -0.73 to -0.21, d = 1.41,  p  < .001). While these findings should be cross-validated in subsequent research with a larger and more diverse participant sample, there appears to be value in minimizing pre-exercise mental fatigue to avoid negative MF effects on the exercisers' affective experience.",2022,"The participants in the MF condition reported lower pleasure ( M  difference = -1.57, 95% CI = -2.64 to -0.50, d = 0.93,  p  = .008) and higher exertion (RPE) ( M  difference = 1.16, 95% CI = 0.04 to 2.27, d = 0.66,  p  = .043) compared to those in the control condition.","['12 insufficiently active adults (50% women;  M  age = 24.9\xa0years,  SD  = 3.0;  M  BMI = 24.3\xa0kg/m 2 ;  SD  = 2.6) to two']","['30-minute pre-exercise conditions: an MF condition (Stroop Color-Word task) and a control condition (watching a documentary) prior to their performance of 20\xa0minutes of aerobic treadmill exercise', 'Mental Fatigue Prior to Aerobic Exercise', 'mental fatigue (MF', 'aerobic exercise session']","['Exercise Pleasure', 'negative implicit attitude toward physical exercise', 'affective and exertion responses with the Feeling Scale, Rating of Perceived Exertion (RPE) and heart rate', 'Perceived MF and motivation to perform physical exercise', 'Implicit attitudes toward physical exercise', 'lower pleasure', 'higher exertion (RPE']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0402444,"The participants in the MF condition reported lower pleasure ( M  difference = -1.57, 95% CI = -2.64 to -0.50, d = 0.93,  p  = .008) and higher exertion (RPE) ( M  difference = 1.16, 95% CI = 0.04 to 2.27, d = 0.66,  p  = .043) compared to those in the control condition.","[{'ForeName': 'Felipe de Azevedo', 'Initials': 'FA', 'LastName': 'Pessoa', 'Affiliation': 'Graduate Program in Physical Education, 28123Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Lucas Camilo', 'Initials': 'LC', 'LastName': 'Pereira', 'Affiliation': 'Graduate Program in Physical Education, 28123Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Andressa', 'Initials': 'A', 'LastName': 'de Oliveira Araújo', 'Affiliation': 'Graduate Program in Physical Education, 28123Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Gledson Tavares Amorim', 'Initials': 'GTA', 'LastName': 'Oliveira', 'Affiliation': 'Graduate Program in Health Sciences, 28123Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Daniel Carvalho', 'Initials': 'DC', 'LastName': 'Pereira', 'Affiliation': 'Graduate Program in Physical Education, 28123Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Hassan Mohamed', 'Initials': 'HM', 'LastName': 'Elsangedy', 'Affiliation': 'Graduate Program in Physical Education, 28123Federal University of Rio Grande do Norte, Natal, Brazil.'}]",Perceptual and motor skills,['10.1177/00315125221091158']
832,34882571,Interactive Versus Static Decision Support Tools for COVID-19: Randomized Controlled Trial.,"BACKGROUND


During the COVID-19 pandemic, medical laypersons with symptoms indicative of a COVID-19 infection commonly sought guidance on whether and where to find medical care. Numerous web-based decision support tools (DSTs) have been developed, both by public and commercial stakeholders, to assist their decision making. Though most of the DSTs' underlying algorithms are similar and simple decision trees, their mode of presentation differs: some DSTs present a static flowchart, while others are designed as a conversational agent, guiding the user through the decision tree's nodes step-by-step in an interactive manner.
OBJECTIVE


This study aims to investigate whether interactive DSTs provide greater decision support than noninteractive (ie, static) flowcharts.
METHODS


We developed mock interfaces for 2 DSTs (1 static, 1 interactive), mimicking patient-facing, freely available DSTs for COVID-19-related self-assessment. Their underlying algorithm was identical and based on the Centers for Disease Control and Prevention's guidelines. We recruited adult US residents online in November 2020. Participants appraised the appropriate social and care-seeking behavior for 7 fictitious descriptions of patients (case vignettes). Participants in the experimental groups received either the static or the interactive mock DST as support, while the control group appraised the case vignettes unsupported. We determined participants' accuracy, decision certainty (after deciding), and mental effort to measure the quality of decision support. Participants' ratings of the DSTs' usefulness, ease of use, trust, and future intention to use the tools served as measures to analyze differences in participants' perception of the tools. We used ANOVAs and t tests to assess statistical significance.
RESULTS


Our survey yielded 196 responses. The mean number of correct assessments was higher in the intervention groups (interactive DST group: mean 11.71, SD 2.37; static DST group: mean 11.45, SD 2.48) than in the control group (mean 10.17, SD 2.00). Decisional certainty was significantly higher in the experimental groups (interactive DST group: mean 80.7%, SD 14.1%; static DST group: mean 80.5%, SD 15.8%) compared to the control group (mean 65.8%, SD 20.8%). The differences in these measures proved statistically significant in t tests comparing each intervention group with the control group (P<.001 for all 4 t tests). ANOVA detected no significant differences regarding mental effort between the 3 study groups. Differences between the 2 intervention groups were of small effect sizes and nonsignificant for all 3 measures of the quality of decision support and most measures of participants' perception of the DSTs.
CONCLUSIONS


When the decision space is limited, as is the case in common COVID-19 self-assessment DSTs, static flowcharts might prove as beneficial in enhancing decision quality as interactive tools. Given that static flowcharts reveal the underlying decision algorithm more transparently and require less effort to develop, they might prove more efficient in providing guidance to the public. Further research should validate our findings on different use cases, elaborate on the trade-off between transparency and convenience in DSTs, and investigate whether subgroups of users benefit more with 1 type of user interface than the other.
TRIAL REGISTRATION


Deutsches Register Klinischer Studien DRKS00028136; https://tinyurl.com/4bcfausx (retrospectively registered).",2022,"Differences between the 2 intervention groups were of small effect sizes and nonsignificant for all 3 measures of the quality of decision support and most measures of participants' perception of the DSTs.
",['adult US residents online in November 2020'],['static or the interactive mock DST'],"['mean number of correct assessments', 'Decisional certainty', ""quality of decision support and most measures of participants' perception of the DSTs""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0262967', 'cui_str': 'Dihydrostreptomycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}]",,0.0873833,"Differences between the 2 intervention groups were of small effect sizes and nonsignificant for all 3 measures of the quality of decision support and most measures of participants' perception of the DSTs.
","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Röbbelen', 'Affiliation': 'Division of Ergonomics, Department of Psychology and Ergonomics (IPA), Technische Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Malte L', 'Initials': 'ML', 'LastName': 'Schmieding', 'Affiliation': 'Institute of Medical Informatics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Kopka', 'Affiliation': 'Institute of Medical Informatics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Balzer', 'Affiliation': 'Institute of Medical Informatics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Feufel', 'Affiliation': 'Division of Ergonomics, Department of Psychology and Ergonomics (IPA), Technische Universität Berlin, Berlin, Germany.'}]",JMIR public health and surveillance,['10.2196/33733']
833,35437114,The Impact of Minimally Invasive Surgery on Treating Patients with Early Cervical Adenocarcinoma.,"OBJECTIVE


To explore the impact of minimally invasive surgery on treating patients with early cervical adenocarcinoma (CA).
METHODS


From April 2016 to December 2019, patients with early CA and underwent surgery were prospectively included in this study. They were randomly divided into 2 groups: the minimally invasive surgery (MIS) group and conventional laparotomy (CL) group. The baseline characteristics, pathological features, surgical related parameters, serum tumor markers, complications and prognosis were analyzed and compared between the 2 groups. The risk factors for disease free survival (DFS) and overall survival (OS) were also analyzed with logistic regression analyses.
RESULT


The baseline characteristic and pathological features had no statistical difference between the 2 groups. The mean operation duration in MIS group was significantly longer than CL group (262.39 ± 34.98 vs 241.29 ± 36.98 min,  P  < 0.001). The intraoperative blood loss volume (189.87 ± 23.87 vs 306.87 ± 24.98 mL,  P  < 0.001), postoperative anal exhaust time (45.98 ± 4.39 vs 59.87 ± 4.87 days,  P  < 0.001), catheter removal time (18.29 ± 3.21 vs 21.53 ± 3.19 days,  P  < 0.001) and length of hospital stay (12.98 ± 2.09 vs 16.98 ± 2.32 days,  P  < 0.001) were significant lower in MIS group. The serum tumor markers decreased significantly postoperative in both groups with no different levels between the 2 groups. The incidence of complications had no difference between the 2 groups except lymphocysts ( P  = 0.023). After mean follow up time for 4.23 ± 0.34 years, the DFS rate and OS rate also had no statistical difference between the 2 groups ( P  = 0.069 and 0.151, respectively).
CONCLUSION


Extensive hysterectomy with MIS was equally efficacy and safe to CL.",2022,The incidence of complications had no difference between the 2 groups except lymphocysts ( P  = 0.023).,"['From April 2016 to December 2019, patients with early CA and underwent surgery', 'Patients with Early Cervical Adenocarcinoma', 'patients with early cervical adenocarcinoma (CA']","['CL', 'Minimally Invasive Surgery', 'minimally invasive surgery', 'minimally invasive surgery (MIS) group and conventional laparotomy (CL']","['intraoperative blood loss volume', 'DFS rate and OS rate', 'disease free survival (DFS) and overall survival (OS', 'catheter removal time', 'mean operation duration', 'length of hospital stay', 'incidence of complications', 'postoperative anal exhaust time', 'baseline characteristics, pathological features, surgical related parameters, serum tumor markers, complications and prognosis']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0279672', 'cui_str': 'Adenocarcinoma of cervix'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",,0.0633407,The incidence of complications had no difference between the 2 groups except lymphocysts ( P  = 0.023).,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Gynaecology and Obstetrics, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, China.'}, {'ForeName': 'Yifen', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Gynaecology and Obstetrics, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Gynaecology and Obstetrics, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, China.'}, {'ForeName': 'Linghu', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Neurosurgery, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, China.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2022.2064009']
834,35440521,Adductor Canal Blocks With Bupivacaine and Magnesium After Same-day Discharge Total Knee Arthroplasty Improve Postoperative Pain Relief and Decrease Opioid Consumption: A Prospective Randomized Controlled Trial.,"OBJECTIVES


Adequate pain management is a critical component of facilitating same-day discharge for total knee arthroplasty (TKA). Adductor canal blocks (ACB) have been shown to be an effective technique for managing pain after TKA. The objective of this study was to investigate the impact of adding magnesium to local anesthetic in ACB on postoperative pain, opioid consumption, nausea, and overall patient satisfaction.
MATERIALS AND METHODS


A sample of 119 adults undergoing elective unilateral TKA were included. Patients were randomly assigned to receive ACB with magnesium and bupivacaine (n=56) or with bupivacaine only (n=63). Primary outcomes were total opioid consumption in the first 48 hours after surgery and pain scores. Secondary outcomes were the incidence of nausea in the first 48 hours after surgery and total overall satisfaction.
RESULTS


Opioid consumption decreased significantly in the Mg group compared with the no-Mg group over the first 24 hours (33.2±3.0 vs. 21.3±2.4, P=0.003), the second 24 hours (35.4±2.7 vs. 27.3±2.3, P=0.026), and the first 48 hours total after surgery (68.6±5.1 vs. 48.6±4.3, P=0.004). Pain scores were reduced in the Mg group (24 h: 5.1±2.3 vs. 3.5±2.0, P=0.000; 48 h: 5.1±1.6 vs. 3.9±1.6, P=0.000). Secondary outcomes showed no difference in the incidence of nausea over the first 48 hours and overall satisfaction.
CONCLUSION


The addition of magnesium to local anesthetic in ACB decreases pain scores and opioid consumption, without increasing nausea, when compared with ACB with local anesthetic alone.",2022,"Pain scores were reduced in the Mg Group (24▒h: 5.1±2.3 vs. 3.5±2.0,P=0.000","['119 adults undergoing elective unilateral TKA were included', 'total knee arthroplasty (TKA']","['ACB with magnesium and bupivacaine', 'bupivacaine', 'Bupivacaine and Magnesium', 'magnesium', 'Adductor canal blocks (ACB']","['post-operative pain, opioid consumption, nausea, and overall patient satisfaction', 'incidence of nausea over the first 48 hours and overall satisfaction', 'Opioid Consumption', 'nausea', 'Opioid consumption', 'Pain scores', 'total opioid consumption in the first 48 hours after surgery and pain scores', 'incidence of nausea in the first 48 hours after surgery and total overall satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",119.0,0.578767,"Pain scores were reduced in the Mg Group (24▒h: 5.1±2.3 vs. 3.5±2.0,P=0.000","[{'ForeName': 'Jae W', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology, Wayne State University School of Medicine, Detroit.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lahori', 'Affiliation': 'Department of Anesthesiology, Wayne State University School of Medicine, Detroit.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Merlo', 'Affiliation': 'Ross University School of Medicine, Barbados.'}, {'ForeName': 'Opinderjit', 'Initials': 'O', 'LastName': 'Gill', 'Affiliation': 'Department of Anesthesiology, Wayne State University School of Medicine, Detroit.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ghoddoussi', 'Affiliation': 'Department of Anesthesiology, Wayne State University School of Medicine, Detroit.'}, {'ForeName': 'Kinjal M', 'Initials': 'KM', 'LastName': 'Patel', 'Affiliation': 'Department of Anesthesiology, Cooper University Healthcare, Camden, NJ.'}, {'ForeName': 'Ronak G', 'Initials': 'RG', 'LastName': 'Desai', 'Affiliation': 'Department of Anesthesiology, Cooper University Healthcare, Camden, NJ.'}, {'ForeName': 'Joffer', 'Initials': 'J', 'LastName': 'Hakim', 'Affiliation': 'Department of Anesthesiology, Wayne State University School of Medicine, Detroit.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Zatkoff', 'Affiliation': 'Department of Anesthesiology, St. Joseph Mercy Oakland Hospital, Pontiac, MI.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': 'Department of Anesthesiology, Wayne State University School of Medicine, Detroit.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000001036']
835,35442504,Comment on: Effect of Vitamin D supplementation in patients with liver cirrhosis having spontaneous bacterial peritonitis: a randomized controlled study.,,2022,,['patients with liver cirrhosis having spontaneous bacterial peritonitis'],['Vitamin D supplementation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],,0.171093,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caturano', 'Affiliation': 'Department of Advanced Medical and Surgical Sciences, University of Campania ""Luigi Vanvitelli"", Naples, Italy. alfredo.caturano@unicampania.it.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Brunelli', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Galiero', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Spiezia', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ferrara', 'Affiliation': ''}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Sasso', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202204_28450']
836,35442486,"Alpha-lipoic acid improved anemia, erythropoietin resistance, maintained glycemic control, and reduced cardiovascular risk in diabetic patients on hemodialysis: a multi-center prospective randomized controlled study.","OBJECTIVE


To investigate the impact of alpha-lipoic acid (ALA) on inflammation, oxidative stress, anemia, and glycemic parameters and their association with cardiovascular risk in diabetic patients on hemodialysis.
PATIENTS AND METHODS


In this multi-center, randomized, controlled study, 60 diabetic patients on hemodialysis were randomized into control group (n=30) which received Epoetin-alpha plus insulin therapy, and alpha-lipoic acid group (n=30) which received the same treatment plus alpha-lipoic acid (ALA) 600 mg once daily. Serum levels of high sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-α), 8-hydroxy-2'-deoxyguanosine (8-OHdG), creatinine, urea, blood urea nitrogen (BUN), hemoglobin (Hb), iron parameters, fasting blood glucose (FBG), glycated hemoglobin (HbA1c), and fructosamine were measured at baseline and six months after intervention. The ankle-brachial index (ABI) was used to evaluate the clinical outcome. Erythropoietin resistance index (ERI), the weekly cost of Epoetin-alpha doses, and the total cost were calculated.
RESULTS


The two groups were statistically similar at baseline. After the intervention, as compared to the control group, ALA group showed significant reductions in serum levels of hs-CRP, TNF-α, 8-OHdG (p<0.001), urea, and BUN (p=0.029) with significant elevations in Hb concentration (p<0.001), serum iron (p=0.037) and transferrin saturation (p<0.001). ALA group showed a significant decline in FBG (p=0.004), HbA1c (p<0.001), fructosamine (p=0.005), ERI (p<0.001), weekly doses, and the weekly cost of Epoetin-alpha, and the total cost (p<0.001). ALA provided a cardio-protective effect, whereas the percentage of patients with acceptable ABI (0.9-1) was significantly higher in ALA group than in the control group (p=0.024), and those with abnormally low ABI (<0.9) were lower in the ALA group.
CONCLUSIONS


Due to its efficacy and safety, alpha-lipoic acid represents a pharmaco-economic supplement for diabetic patients on hemodialysis. Further trials are needed for complete evaluation of ALA effects.",2022,"After the intervention, as compared to the control group, ALA group showed significant reductions in serum levels of hs-CRP, TNF-α, 8-OHdG (p<0.001), urea, and BUN (p=0.029) with significant elevations in Hb concentration (p<0.001), serum iron (p=0.037) and transferrin saturation (p<0.001).","['60 diabetic patients on hemodialysis', 'diabetic patients on hemodialysis']","['alpha-lipoic acid (ALA', 'ALA', 'Epoetin-alpha plus insulin therapy, and alpha-lipoic acid group (n=30) which received the same treatment plus alpha-lipoic acid (ALA']","['acceptable ABI', 'Hb concentration (p<0.001), serum iron (p=0.037) and transferrin saturation', 'total cost', 'anemia, erythropoietin resistance', 'serum levels of hs-CRP, TNF-α, 8-OHdG (p<0.001), urea, and BUN', 'inflammation, oxidative stress, anemia, and glycemic parameters', 'Erythropoietin resistance index (ERI', ""Serum levels of high sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-α), 8-hydroxy-2'-deoxyguanosine (8-OHdG), creatinine, urea, blood urea nitrogen (BUN), hemoglobin (Hb), iron parameters, fasting blood glucose (FBG), glycated hemoglobin (HbA1c), and fructosamine"", 'FBG', 'efficacy and safety', 'cardiovascular risk', 'weekly cost of Epoetin-alpha, and the total cost', 'ankle-brachial index (ABI']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",60.0,0.0151263,"After the intervention, as compared to the control group, ALA group showed significant reductions in serum levels of hs-CRP, TNF-α, 8-OHdG (p<0.001), urea, and BUN (p=0.029) with significant elevations in Hb concentration (p<0.001), serum iron (p=0.037) and transferrin saturation (p<0.001).","[{'ForeName': 'D Z', 'Initials': 'DZ', 'LastName': 'Abdel Hamid', 'Affiliation': 'Alexandria Hepatology, Gastroenterology and Fever Hospital, Alexandria, Egypt. pg_87899@pharm.tanta.edu.eg.'}, {'ForeName': 'Y A', 'Initials': 'YA', 'LastName': 'Nienaa', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Mostafa', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202204_28461']
837,35442482,"Effect of two incremental intensity field tests on wellness indices, recovery state, and physical enjoyment in soccer players.","OBJECTIVE


Competitive athletes must undergo fitness testing to monitor athlete progress and to create appropriate, progressive training programs. However, fitness testing adds to training stress; therefore, impacts of testing on wellness and recovery must be considered in test selection. This study investigated the effects of two incremental field tests [VAMEVAL test (T-VAM) and 20-m maximum shuttle test (20-m MST)] on wellness, total quality of recovery (TQR) and physical enjoyment (PE) in competitive soccer players.
SUBJECTS AND METHODS


Twenty-two soccer players (20.9±1.5 years) completed two T-VAM and two 20-m MST in a randomized order on separate days with a 1-week interval between tests. TQR and wellness indices (sleep, fatigue, stress and muscle soreness) measures were collected before and 24 hours after each test. Heart rate (HR) was continuously monitored during each test. Rating of perceived exertion (RPE) and PE were assessed after each test.
RESULTS


T-VAM resulted in higher PE, TQR and wellness scores than 20-m MST (p<0.05). T-VAM and 20-m MST resulted in similar HR and maximal aerobic speed. For T-VAM, TQR was correlated (p<0.01) with RPE and wellness indices. For 20-m MST, TQR was correlated (p<0.01) with wellness indices. HRmax and RPE were not correlated with wellness indices, TQR or PE.
CONCLUSIONS


Overall, T-VAM and 20-m MST produced similar aerobic fitness testing results, but athletes responded more favorably to T-VAM. Coaches can use T-VAM for evaluating aerobic fitness while maximizing well-being and physical enjoyment among soccer players.",2022,"For T-VAM, TQR was correlated (p<0.01) with RPE and wellness indices.","['soccer players', 'Twenty-two soccer players (20.9±1.5 years) completed two T-VAM and two 20-m', 'competitive soccer players']","['MST', 'incremental field tests [VAMEVAL test (T-VAM) and 20-m maximum shuttle test (20-m MST']","['Rating of perceived exertion (RPE) and PE', 'HRmax and RPE', 'higher PE, TQR and wellness scores', 'similar HR and maximal aerobic speed', 'wellness indices, recovery state, and physical enjoyment', 'TQR and wellness indices (sleep, fatigue, stress and muscle soreness) measures', 'Heart rate (HR', 'wellness, total quality of recovery (TQR) and physical enjoyment (PE']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1834582', 'cui_str': 'Transient abnormal myelopoiesis'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0430518', 'cui_str': 'Shuttle test'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0464091,"For T-VAM, TQR was correlated (p<0.01) with RPE and wellness indices.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Selmi', 'Affiliation': 'Research Unit, Sportive Performance and Physical Rehabilitation, High Institute of Sports and Physical Education of Kef, University of Jendouba, Kef, Tunisia. beat.knechtle@hispeed.ch.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Levitt', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muscella', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ouerghi', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Issaoui', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Abassi', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rosemann', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bouassida', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202204_28457']
838,35443106,Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19.,"BACKGROUND


The monoclonal-antibody combination AZD7442 is composed of tixagevimab and cilgavimab, two neutralizing antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that have an extended half-life and have been shown to have prophylactic and therapeutic effects in animal models. Pharmacokinetic data in humans indicate that AZD7442 has an extended half-life of approximately 90 days.
METHODS


In an ongoing phase 3 trial, we enrolled adults (≥18 years of age) who had an increased risk of an inadequate response to vaccination against coronavirus disease 2019 (Covid-19), an increased risk of exposure to SARS-CoV-2, or both. Participants were randomly assigned in a 2:1 ratio to receive a single dose (two consecutive intramuscular injections, one containing tixagevimab and the other containing cilgavimab) of either 300 mg of AZD7442 or saline placebo, and they were followed for up to 183 days in the primary analysis. The primary safety end point was the incidence of adverse events after a single dose of AZD7442. The primary efficacy end point was symptomatic Covid-19 (SARS-CoV-2 infection confirmed by means of reverse-transcriptase-polymerase-chain-reaction assay) occurring after administration of AZD7442 or placebo and on or before day 183.
RESULTS


A total of 5197 participants underwent randomization and received one dose of AZD7442 or placebo (3460 in the AZD7442 group and 1737 in the placebo group). The primary analysis was conducted after 30% of the participants had become aware of their randomized assignment. In total, 1221 of 3461 participants (35.3%) in the AZD7442 group and 593 of 1736 participants (34.2%) in the placebo group reported having at least one adverse event, most of which were mild or moderate in severity. Symptomatic Covid-19 occurred in 8 of 3441 participants (0.2%) in the AZD7442 group and in 17 of 1731 participants (1.0%) in the placebo group (relative risk reduction, 76.7%; 95% confidence interval [CI], 46.0 to 90.0; P<0.001); extended follow-up at a median of 6 months showed a relative risk reduction of 82.8% (95% CI, 65.8 to 91.4). Five cases of severe or critical Covid-19 and two Covid-19-related deaths occurred, all in the placebo group.
CONCLUSIONS


A single dose of AZD7442 had efficacy for the prevention of Covid-19, without evident safety concerns. (Funded by AstraZeneca and the U.S. government; PROVENT ClinicalTrials.gov number, NCT04625725.).",2022,"A single dose of AZD7442 had efficacy for the prevention of Covid-19, without evident safety concerns.","['enrolled adults (≥18 years of age) who had an increased risk of an inadequate response to vaccination against coronavirus disease 2019 (Covid-19), an increased risk of exposure to SARS-CoV-2, or both', '5197 participants underwent randomization and received one dose of']","['AZD7442', 'Intramuscular AZD7442 (Tixagevimab-Cilgavimab', 'placebo', 'tixagevimab and the other containing cilgavimab) of either 300 mg of AZD7442 or saline placebo', 'AZD7442 or placebo']","['incidence of adverse events', 'severe or critical Covid-19 and two Covid-19-related deaths', 'Symptomatic Covid-19', 'symptomatic Covid-19 (SARS-CoV-2 infection confirmed by means of reverse-transcriptase-polymerase-chain-reaction assay', 'relative risk reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C2733460', 'cui_str': 'Exposure to severe acute respiratory syndrome coronavirus'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",5197.0,0.797242,"A single dose of AZD7442 had efficacy for the prevention of Covid-19, without evident safety concerns.","[{'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ustianowski', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'De Wit', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Avila', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Templeton', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Seegobin', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Ellery', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Levinson', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ambery', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Rosalinda H', 'Initials': 'RH', 'LastName': 'Arends', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Rohini', 'Initials': 'R', 'LastName': 'Beavon', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Dey', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Garbes', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Kelly', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Gavin C K W', 'Initials': 'GCKW', 'LastName': 'Koh', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Near', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Padilla', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Psachoulia', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Sharbaugh', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Streicher', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Menelas N', 'Initials': 'MN', 'LastName': 'Pangalos', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Esser', 'Affiliation': 'From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) - all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels (S.D.W.); Université de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique-Hôpitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (M.A., Y.Y.), Translational Medicine (E.J.K., K.S.), and Vaccines and Immune Therapies (M.T.E.), Biopharmaceuticals Research and Development, AstraZeneca, Gaithersburg, MD; and Clinical Development, Vaccines and Immune Therapies, Biopharmaceuticals Research and Development, AstraZeneca, Durham, NC (K.W.P., A.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2116620']
839,35446902,Effects of a locally available dietary interventions counselling on the community-based management of anaemia in children under five years in Ghana: Kumbungu cluster randomized controlled trial protocol.,"Anaemia in children under five years remains a significant cause of mortality and morbidity in low-middle income countries. Globally, 27% of the world's population is anaemic, of which developing countries account for more than 89%. The global prevalence is worse in Africa and Asia. Anaemia has the potential of maintaining the cycle of poverty, as it prevents children from attaining their full development potential. An important part of anaemia in children under-five years are preventable. Locally available dietary (LAD) interventions may be the sustainable interventions to address the high prevalence of anaemia in our communities. The aim of the study is to determine the effect of counselling on Locally Available Diet, on anaemia among children aged 6-59 months in the Kumbungu District of the Northern Region, Ghana. This study will be a community-based cluster randomized, controlled trial, with two parallel arms; Iron + Folic Acid (IFA arm) hereby referred to as the Standard care arm and Iron + Folic Acid + Counselling on Locally available dietary intervention (IFA+LAD arm) referred to as the Standard Plus arm. Study participants are children between the ages of 6 to 56 months. All study participants would receive iron plus folic acid. The minimum number of children per arm is 330 and the number of community clusters is 10 (5 per study arm). Also, considering this study proposes two parallel arms, the total minimum study sample size of children under five years is 496, the minimum total number of community clusters is 10 and a minimum of 25 households per community cluster, 124 households per study arm and 248 households for the study. Randomization is at the level of the clusters (selected communities). The intervention group receives counselling on LAD at a household level aimed at promoting the intake of locally available iron, folate and vitamin B12 rich foods. Also encourage the intake of food rich in enhancers of iron absorption and discouraging the intake of food rich in inhibitors of iron absorption. The primary outcome is mean haemoglobin levels in study arms. Secondary outcomes would include measurement of weight, height/length, mid upper arm circumference, dietary record, serum iron, ferritin, and other parameters of full blood count. Ethical clearance has been obtained and trial registered with Pan African Trial Registry (www.pactr.org) PACTR201906918438423.",2022,"Globally, 27% of the world's population is anaemic, of which developing countries account for more than 89%.","['children aged 6-59 months in the Kumbungu District of the Northern Region, Ghana', 'children under five years in Ghana', 'children under five years is 496, the minimum total number of community clusters is 10 and a minimum of 25 households per community cluster, 124 households per study arm and 248 households for the study', 'Study participants are children between the ages of 6 to 56 months']","['Iron + Folic Acid (IFA arm) hereby referred to as the Standard care arm and Iron + Folic Acid + Counselling', 'locally available dietary interventions counselling', 'Locally available dietary (LAD) interventions', 'counselling on LAD at a household level aimed at promoting the intake of locally available iron, folate and vitamin B12 rich foods', 'iron plus folic acid']","['mortality and morbidity', 'measurement of weight, height/length, mid upper arm circumference, dietary record, serum iron, ferritin, and other parameters of full blood count', 'mean haemoglobin levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0281643', 'cui_str': ""incomplete Freund's adjuvant""}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.167336,"Globally, 27% of the world's population is anaemic, of which developing countries account for more than 89%.","[{'ForeName': 'Benjamin Demah', 'Initials': 'BD', 'LastName': 'Nuertey', 'Affiliation': 'Community Health Department, University of Ghana Medical School, Korle-Bu, Accra, Ghana.'}, {'ForeName': 'Alfred E', 'Initials': 'AE', 'LastName': 'Yawson', 'Affiliation': 'Community Health Department, University of Ghana Medical School, Korle-Bu, Accra, Ghana.'}, {'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Addai', 'Affiliation': 'Department of Medicine, Korle-Bu Teaching Hospital, Korle-Bu, Accra, Ghana.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Biritwum', 'Affiliation': 'Community Health Department, University of Ghana Medical School, Korle-Bu, Accra, Ghana.'}]",PloS one,['10.1371/journal.pone.0266157']
840,35446735,"Long-term effect of mobile phone-based education and influencing factors of willingness to receive HPV vaccination among female freshmen in Shanxi Province, China.","BACKGROUND


This study was conducted to characterize the long-term effect of mobile-based education on Chinese female freshmen and disclose the possible predictors of their willingness to get vaccinated based on the information-motivation-behavioral skills (IMB) model.
METHODS


We randomly assigned 509 participants to a 7-day mobile-based educational intervention or control group and collected information about general information, health, and sexual behavior, HPV vaccination intention and action, HPV-related knowledge, cognition, and behavioral skill by an online self-administrated questionnaire at baseline, post-intervention, and at the 1-month and 3-month follow-ups.
RESULTS


The intervention arm showed an improvement in IMB scores after education. Despite the persistent improvement in knowledge, the improvement in their motivation and behavioral skills decreased at the 1-month and 3-month follow-ups. Participants' vaccination willingness was elevated after the baseline survey in both the intervention and control groups, while the overall appointment/vaccination rate was only 3.73% 3 months later. The intention to get vaccinated was associated with knowing HPV (adjusted OR: 2.37, 95% CI: 1.44 - 3.89), perceiving more barriers (adjusted OR: 2.16, 95% CI: 1.44 - 3.25), higher subjective norms (adjusted OR: 2.05, 95% CI: 1.26 - 3.32), and having more behavioral skills (adjusted OR: 2.95, 95% CI: 1.79 - 4.87).
CONCLUSION


Seven-day mobile-based education was effective to increase IMB model scores among female freshmen. However, the improvement in motivation and behavioral skills was not persistent. Information, perceived barriers, subjective norms, and behavioral skills were discovered to be influencing factors of vaccination intention. Future research with longer, more convenient, and more tailored education to the main influencing factors is warranted.",2022,"The intention to get vaccinated was associated with knowing HPV (adjusted OR: 2.37, 95% CI: 1.44 - 3.89), perceiving more barriers (adjusted OR: 2.16, 95% CI: 1.44 - 3.25), higher subjective norms (adjusted OR: 2.05, 95% CI: 1.26 - 3.32), and having more behavioral skills (adjusted OR: 2.95, 95% CI: 1.79 - 4.87).
","['female freshmen in Shanxi Province, China']","['7-day mobile-based educational intervention or control group and collected information about general information, health, and sexual behavior, HPV vaccination intention and action, HPV-related knowledge, cognition, and behavioral skill by an online self-administrated questionnaire at baseline, post-intervention', 'mobile phone-based education', 'HPV vaccination', 'mobile-based education']","['IMB model scores', 'behavioral skills', 'motivation and behavioral skills', 'IMB scores', 'Information, perceived barriers, subjective norms, and behavioral skills', 'overall appointment/vaccination rate', 'vaccination willingness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",509.0,0.0692302,"The intention to get vaccinated was associated with knowing HPV (adjusted OR: 2.37, 95% CI: 1.44 - 3.89), perceiving more barriers (adjusted OR: 2.16, 95% CI: 1.44 - 3.25), higher subjective norms (adjusted OR: 2.05, 95% CI: 1.26 - 3.32), and having more behavioral skills (adjusted OR: 2.95, 95% CI: 1.79 - 4.87).
","[{'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ""Department of Pediatrics and Adolescent Gynecology, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'School of Public Health, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': ""Department of Pediatrics and Adolescent Gynecology, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Sunyi', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Binghan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Division of Health Promotion, Ningbo Municipal Center for Disease Control and Prevention, Ningbo, China.'}, {'ForeName': 'Jianbing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Epidemiology and Biostatistics at School of Public Health and National Clinical Research Center for Child Health of the Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Changzheng', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': ""Department of Pediatrics and Adolescent Gynecology, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Beijing Office for Cancer Prevention and Control, Peking University Cancer Hospital & Institute, Beijing, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2051990']
841,35447154,Environmental health literacy for Anishinaabe (Great Lakes Native American) fish consumers: A randomized control trial.,"BACKGROUND


Fish consumption comprises an important part of what the Anishinaabe (Great Lakes Native Americans) call ""minobimaadiziiwin"" which translates roughly to ""living in a good way"". Industrial activity leading to the accumulation of persistent contaminants in fish disrupts minobimaadiziiwin. Our team of academic and Anishinaabe scientists co-developed a fish consumption advisory for the Anishinaabe using software that can be accessed via mobile phones and/or the internet.
OBJECTIVES


The software, Gigiigoo'inaan (""our fish"") is designed to improve environmental health literacy using culturally congruent messaging and aesthetics. We tested the following hypotheses: 1) the Gigiigoo'inaan would encourage consumption of fish high in Polyunsaturated Omega-3 fatty acids (PFUA-3) whilst minimizing contaminant intake (methylmercury (MeHg) and Polychorinated Biphenyls (PCBs)); and 2) intervention participants will be more likely than controls to achieve a favorable n-3 PUFA/MeHg consumption ratios.
METHODS


We conducted a randomized controlled trial with prospective self-reported fish consumption using automated email surveys. One-month pre and one month post, control and intervention outcome variables were calculated per participant as µg/kg/day of MeHg, µg/kg/day of PCB, g of fish, and mg/day of EPA+DHA. These were modeled using an analysis of covariance (ANCOVA) with a-priori covariates: age, sex, and tribal affiliation.
RESULTS


Most participants in both trial arms reported eating relatively elevated amounts of fish yet remained within advisory guidelines for contaminants. EPA+DHA:MeHg ratios were also favorable in most participants. Advisory limits for contaminants were exceeded by relatively few participants in the study.
DISCUSSION


Gigiigoo'inaan was previously reported to increase confidence, the current user feedback confirms this. Most participants ate fish but did not exceed the advisory limits, which demonstrates Environmental Health Literacy progress in the region despite a lack of observed behavior change during the trial. A small number of participants exceeded contaminant intake guidelines which matches the pilot work for this study.",2022,,['Environmental health literacy for Anishinaabe (Great Lakes Native American) fish consumers'],[],[],"[{'cui': 'C0014413', 'cui_str': 'Health, Environmental'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]",[],[],,0.0790779,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Dellinger', 'Affiliation': 'Medical College of Wisconsin, USA. Electronic address: mdellinger@mcw.edu.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Pingatore', 'Affiliation': 'Inter-Tribal Council of Michigan, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chelius', 'Affiliation': 'Medical College of Wisconsin, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Visotcky', 'Affiliation': 'Medical College of Wisconsin, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Sparapani', 'Affiliation': 'Medical College of Wisconsin, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ripley', 'Affiliation': 'Chippewa Ottawa Resource Authority, USA.'}]",Environmental research,['10.1016/j.envres.2022.113335']
842,35439700,Mid-term outcomes of exercise therapy for the non-surgical management of femoroacetabular impingement syndrome: are short-term effects persisting?,"OBJECTIVES


To investigate the mid-term outcomes of exercise therapy in patients with femoroacetabular impingement syndrome (FAIS).
DESIGN


Follow-up study.
SETTING


Clinical setting.
PARTICIPANTS


Twenty-six patients with FAIS who completed a 12-week semi-standardized, progressive exercise therapy program.
MAIN OUTCOME MEASURES


At a mid-term follow-up of 4.6 years, therapy outcome was assessed using (i) the Global Treatment Outcome questionnaire for hip pain, (ii) the Hip Outcome Score (HOS) for hip pain and function in activities of daily living (ADL) and Sport and (iii) the Hip Sports Activity Scale (HSAS) for sport activity level. Mid-term outcomes were compared to pre-symptomatic, pre-therapy, as well as to short-term follow ups (18 weeks).
RESULTS


In patients who completed the exercise program and did not undergo hip surgery (N = 19), mid-term HOS ADL and HOS Sport (P = 0.002) were higher than pre-therapy, and comparable to the 18-week follow-up. Mid-term HSAS was lower than the pre-symptomatic status (P = 0.022), but comparable to the 18-week follow-up.
CONCLUSION


At a mid-term follow-up of 4.6 years, FAIS patients with no subsequent hip surgery maintained the good exercise therapy outcomes and the level of sport activity achieved at short term.",2022,"(P = 0.002) were higher than pre-therapy, and comparable to the 18-week follow-up. Mid-term HSAS was lower than the pre-symptomatic status (P = 0.022), but comparable to the 18-week follow-up.
","['patients with femoroacetabular impingement syndrome (FAIS', 'Twenty-six patients with FAIS who completed a 12-week', 'femoroacetabular impingement syndrome']","['HOS Sport', 'exercise therapy', 'semi-standardized, progressive exercise therapy program', 'exercise program and did not undergo hip surgery']","['level of sport activity', 'Global Treatment Outcome questionnaire for hip pain, (ii) the Hip Outcome Score (HOS) for hip pain and function in activities of daily living (ADL) and Sport and (iii) the Hip Sports Activity Scale (HSAS) for sport activity level. Mid-term outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",26.0,0.0282826,"(P = 0.002) were higher than pre-therapy, and comparable to the 18-week follow-up. Mid-term HSAS was lower than the pre-symptomatic status (P = 0.022), but comparable to the 18-week follow-up.
","[{'ForeName': 'Samara', 'Initials': 'S', 'LastName': 'Monn', 'Affiliation': 'Human Performance Lab, Schulthess Clinic, Zurich, Switzerland. Electronic address: samara.monn@kws.ch.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Maffiuletti', 'Affiliation': 'Human Performance Lab, Schulthess Clinic, Zurich, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Bizzini', 'Affiliation': 'Human Performance Lab, Schulthess Clinic, Zurich, Switzerland.'}, {'ForeName': 'Reto', 'Initials': 'R', 'LastName': 'Sutter', 'Affiliation': 'Department of Radiology, Orthopaedic University Hospital Balgrist, Zurich, Switzerland; Faculty of Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Florian D', 'Initials': 'FD', 'LastName': 'Naal', 'Affiliation': 'Department of Orthopaedic Surgery, Schulthess Clinic, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Leunig', 'Affiliation': 'Department of Orthopaedic Surgery, Schulthess Clinic, Zurich, Switzerland.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Casartelli', 'Affiliation': 'Human Performance Lab, Schulthess Clinic, Zurich, Switzerland; Laboratory of Exercise and Health, ETH Zurich, Schwerzenbach, Switzerland.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2022.04.007']
843,35440808,Correction: Predictive power of home blood pressure in the evening compared with home blood pressure in the morning and office blood pressure before treatment and in the on-treatment follow-up period: a post hoc analysis of the HOMED-BP study.,,2022,,[],[],[],[],[],[],,0.0591549,,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Uchida', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kikuya', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan. Kikuyam@med.teikyo-u.ac.jp.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Asayama', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Ohata', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Imai', 'Affiliation': 'Tohoku Institute for Management of Blood Pressure, Sendai, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-022-00917-0']
844,35446600,"For Head and Neck Cancer, It Is Still Cisplatin, But How Much, How Often, and How Tolerable? New Randomized Phase III Data For the Adjuvant Setting.",,2022,,[],[],[],[],[],[],,0.0922642,,"[{'ForeName': 'D Neil', 'Initials': 'DN', 'LastName': 'Hayes', 'Affiliation': 'University of Tennessee Health Science Center, UTHSC Center for Cancer Research, Memphis, TN.'}, {'ForeName': 'John Patrick', 'Initials': 'JP', 'LastName': 'Gleysteen', 'Affiliation': 'University of Tennessee Health Science Center, UTHSC Center for Cancer Research, Memphis, TN.'}, {'ForeName': 'David Louis', 'Initials': 'DL', 'LastName': 'Schwartz', 'Affiliation': 'University of Tennessee Health Science Center, UTHSC Center for Cancer Research, Memphis, TN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.22.00274']
845,35447506,Machine learning detects predictors of symptom severity and impulsivity after dialectical behavior therapy skills training group in borderline personality disorder.,"Only 50% of the patients with Borderline Personality Disorder (BPD) respond to psychotherapies, such as Dialectical Behavioral Therapy (DBT), this might be increased by identifying baseline predictors of clinical change. We use machine learning to detect clinical features that could predict improvement/worsening for severity and impulsivity of BPD after DBT skills training group. To predict illness severity, we analyzed data from 125 patients with BPD divided into 17 DBT psychotherapy groups, and for impulsiveness we analyzed 89 patients distributed into 12 DBT groups. All patients were evaluated at baseline using widely self-report tests; ∼70% of the sample were randomly selected and two machine learning models (lasso and Random forest [Rf]) were trained using 10-fold cross-validation and compared to predict the post-treatment response. Models' generalization was assessed in ∼30% of the remaining sample. Relevant variables for DBT (i.e. the mindfulness ability ""non-judging"", or ""non-planning"" impulsiveness) measured at baseline, were robust predictors of clinical change after six months of weekly DBT sessions. Using 10-fold cross-validation, the Rf model had significantly lower prediction error than lasso for the BPD severity variable, Mean Absolute Error (MAE) lasso - Rf = 1.55 (95% CI, 0.63-2.48) as well as for impulsivity, MAE lasso - Rf = 1.97 (95% CI, 0.57-3.35). According to Rf and the permutations method, 34/613 significant predictors for severity and 17/613 for impulsivity were identified. Using machine learning to identify the most important variables before starting DBT could be fundamental for personalized treatment and disease prognosis.",2022,"Using 10-fold cross-validation, the Rf model had significantly lower prediction error than lasso for the BPD severity variable, Mean Absolute Error (MAE) lasso - Rf = ","['borderline personality disorder', 'patients with Borderline Personality Disorder (BPD', '125 patients with BPD divided into 17 DBT psychotherapy groups, and for impulsiveness we analyzed 89 patients distributed into 12 DBT groups']","['Machine learning', 'machine learning models (lasso and Random forest [Rf', 'Dialectical Behavioral Therapy (DBT']","['BPD severity variable, Mean Absolute Error (MAE) lasso - Rf\xa0']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0332286', 'cui_str': 'Into'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",125.0,0.0353492,"Using 10-fold cross-validation, the Rf model had significantly lower prediction error than lasso for the BPD severity variable, Mean Absolute Error (MAE) lasso - Rf = ","[{'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Jiménez', 'Affiliation': 'Facultad de Psicología, Universidad Nacional Autónoma de México, Mexico City, Mexico. Electronic address: said.ejp@comunidad.unam.mx.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Angeles-Valdez', 'Affiliation': 'Instituto de Neurobiología, Universidad Nacional Autónoma de México Campus Juriquilla, Querétaro, Mexico.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Rodríguez-Delgado', 'Affiliation': 'Clínica de Trastorno Lımite de la Personalidad, Instituto Nacional de Psiquiatría ""Ramón de la Fuente Muñiz"", Mexico City, Mexico.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fresán', 'Affiliation': 'Subdirección de Investigaciones Clınicas, Instituto Nacional de Psiquiatrıa Ramón de la Fuente Muñız, Mexico City, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Miranda', 'Affiliation': 'Clínica de Trastorno Lımite de la Personalidad, Instituto Nacional de Psiquiatría ""Ramón de la Fuente Muñiz"", Mexico City, Mexico.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Alcalá-Lozano', 'Affiliation': 'Subdirección de Investigaciones Clınicas, Instituto Nacional de Psiquiatrıa Ramón de la Fuente Muñız, Mexico City, Mexico.'}, {'ForeName': 'Xóchitl', 'Initials': 'X', 'LastName': 'Duque-Alarcón', 'Affiliation': 'Clınica de Especialidades en Neuropsiquiatrıa, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE), Mexico City, Mexico.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Arango de Montis', 'Affiliation': 'Clínica de Trastorno Lımite de la Personalidad, Instituto Nacional de Psiquiatría ""Ramón de la Fuente Muñiz"", Mexico City, Mexico.'}, {'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Garza-Villarreal', 'Affiliation': 'Instituto de Neurobiología, Universidad Nacional Autónoma de México Campus Juriquilla, Querétaro, Mexico. Electronic address: egarza@comunidad.unam.mx.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.03.063']
846,35448974,"Resistance training for Black men with depressive symptoms: a pilot randomized controlled trial to assess acceptability, feasibility, and preliminary efficacy.","BACKGROUND


Depression is under-recognized in Black men, who are less likely to seek or have access to psychiatric treatment. Resistance training (RT; i.e., weight lifting) can improve depressive symptoms and may be more acceptable to Black men, but its effects have not been examined for Black men with depressive symptoms.
METHODS


Fifty Black men with depressive symptoms were randomized to either (a) 12 weeks of RT (coupled with Behavioral Activation techniques to promote adherence) or (b) an attention-control group (Health, Wellness, and Education; HWE). Both groups met twice/week for 12 weeks, and follow-up assessments were done at end-of-treatment (EOT) and 6 months after enrollment. Changes in physical activity and muscular strength were collected as a manipulation check. The primary outcome was interviewer assessed symptoms of depression using the Quick Inventory of Depression Symptomology (QIDS). Secondary outcomes included self-reported depressive symptoms, anxiety, and stress. The association between change in QIDS from baseline to EOT and concurrent changes in physical activity and muscular strength in the RT group were explored as an initial assessment of mechanism. Longitudinal mixed effects regression models with subject-specific intercepts were used to examine intervention effects.
RESULTS


A sample with high rates of medical comorbidities (e.g., 44% HIV positive), substance use (e.g., 34% smoking), and negative social determinates of health (e.g., 50% unemployed) was enrolled. Recruitment, engagement, and retention data indicate that the intervention and design were feasible. The RT group showed greater gains in self-reported exercise (b = 270.94, SE = 105.69, p = .01) and muscular strength (b = 11.71, SE = 4.23, p = .01 for upper body and b = 4.24, SE = 2.02, p = .04 for lower body) than the HWE group. The RT group had greater reductions in QIDS scores at both EOT (b = -3.00, SE = 1.34, p = .01) and 6 months (b = -2.63, SE = 1.81, p = .04). The RT group showed a greater reduction in anxiety at EOT (b = -2.67, SE = 1.06, p = .02). Findings regarding self-reported depressive symptoms and stress were non-significant, but in the expected direction with effect sizes in the small to medium range. In the RT group, improvement on the QIDS between baseline and EOT was associated with concurrent improvements in physical activity (b = 21.03, SE = 11.16, p = .02) and muscular strength (b = 1.27, SE = .44, p = .03 for upper body and b = .75, SE = .14, p = .03 for lower body).
CONCLUSIONS


Results suggest that RT is feasible and may be efficacious for reducing depressive symptoms among underserved urban Black men.
TRIAL REGISTRATION


ClinicalTrial.gov #: NCT03107039 (Registered 11/04/2017).",2022,"The RT group showed greater gains in self-reported exercise (b = 270.94, SE = 105.69, p = .01) and muscular strength (b = 11.71, SE = 4.23, p = .01 for upper body and b = 4.24, SE = 2.02, p = .04 for lower body) than the HWE group.","['Black men', 'Black men with depressive symptoms', 'Fifty Black men with depressive symptoms', 'underserved urban Black men', 'A sample with high rates of medical comorbidities (e.g., 44% HIV positive), substance use (e.g., 34% smoking), and negative social determinates of health (e.g., 50% unemployed) was enrolled']","['Resistance training (RT; i.e., weight lifting', 'Resistance training', 'RT (coupled with Behavioral Activation techniques to promote adherence) or (b) an attention-control group (Health, Wellness, and Education; HWE']","['QIDS scores', 'self-reported depressive symptoms, anxiety, and stress', 'physical activity', 'anxiety at EOT', 'depressive symptoms', 'physical activity and muscular strength', 'QIDS', 'symptoms of depression using the Quick Inventory of Depression Symptomology (QIDS', 'gains in self-reported exercise', 'muscular strength']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205259', 'cui_str': 'Determinate'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0043095', 'cui_str': 'Weight Lifting'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449263', 'cui_str': 'Activation technique'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",50.0,0.0263672,"The RT group showed greater gains in self-reported exercise (b = 270.94, SE = 105.69, p = .01) and muscular strength (b = 11.71, SE = 4.23, p = .01 for upper body and b = 4.24, SE = 2.02, p = .04 for lower body) than the HWE group.","[{'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Ciccolo', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, New York, NY, 10027, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Louie', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, New York, NY, 10027, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'SantaBarbara', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, New York, NY, 10027, USA.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Webster', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, New York, NY, 10027, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Whitworth', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, New York, NY, 10027, USA.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Nosrat', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, New York, NY, 10027, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Chrastek', 'Affiliation': 'Behavioral Health Equity Research Group, Hennepin Healthcare Research Institute, 701 Park Ave, Suite PP7.700, Minneapolis, MN, 55415, USA.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02903, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Carey', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02903, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Busch', 'Affiliation': 'Behavioral Health Equity Research Group, Hennepin Healthcare Research Institute, 701 Park Ave, Suite PP7.700, Minneapolis, MN, 55415, USA. andrew.busch@hcmed.org.'}]",BMC psychiatry,['10.1186/s12888-022-03935-x']
847,35460295,Beta 2  -agonist increases skeletal muscle interleukin 6 production and release in response to resistance exercise in men.,"OBJECTIVE


Several tissues produce and release interleukin-6 (IL-6) in response to beta 2  -adrenergic stimulation with selective agonists (beta 2  -agonists). Moreover, exercise stimulates muscle IL-6 production, but whether beta 2  -agonists regulate skeletal muscle production and release of IL-6 in humans in association with exercise remains to be clarified. Thus, we investigated leg IL-6 release in response to beta 2  -agonist salbutamol in lean young men at rest and in recovery from resistance exercise.
DESIGN


The study employed a randomized controlled crossover design, where 12 men ingested either salbutamol (16 mg) or placebo for 4 days, followed by the last dose (24 mg) administered 1½ h before exercise. Arterial and femoral venous plasma IL-6 as well as femoral artery blood flow was measured before and ½-5 h in recovery from quadriceps muscle resistance exercise. Furthermore, vastus lateralis muscle biopsies were collected ½ and 5 h after exercise for determination of mRNA levels of IL-6 and Tumor Necrosis Factor (TNF)-α.
RESULTS


Average leg IL-6 release was 1.7-fold higher (p = 0.01) for salbutamol than placebo, being 138 ± 76 and 79 ± 66 pg min -1  (mean ± SD) for salbutamol and placebo, respectively, but IL-6 release was not significantly different between treatments within specific sampling points at rest and after exercise. Muscle IL-6 mRNA was 1.5- and 1.7-fold higher (p = 0.001) for salbutamol than placebo ½ and 5 h after exercise, respectively, whereas no significant treatment differences were observed for TNF-α mRNA.
CONCLUSIONS


Beta 2  -adrenergic stimulation with high doses of the selective beta 2  -agonist salbutamol, preceeded by 4 consecutive daily doses, induces transcription of IL-6 in skeletal muscle in response to resistance exercise, and increases muscle IL-6 release in lean individuals.",2022,"Muscle IL-6 mRNA was 1.5 and 1.7-fold higher (p=0.001) for salbutamol than placebo ½ and 5 h after exercise, respectively, whereas no significant treatment differences were observed for TNF-α mRNA.
","['lean young men at rest and in recovery from resistance exercise', '12 men ingested either', 'men', 'lean individuals']","['placebo', 'salbutamol (16 mg) or placebo']","['Muscle IL-6 mRNA', 'leg IL-6 release', 'IL-6 release', 'Arterial and femoral venous plasma IL-6', 'muscle IL-6 release', 'Furthermore, vastus lateralis muscle biopsies', 'femoral artery blood flow']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C3838734', 'cui_str': 'Venous plasma'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.0842203,"Muscle IL-6 mRNA was 1.5 and 1.7-fold higher (p=0.001) for salbutamol than placebo ½ and 5 h after exercise, respectively, whereas no significant treatment differences were observed for TNF-α mRNA.
","[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hostrup', 'Affiliation': 'August Krogh Section of Human Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob Grunnet', 'Initials': 'JG', 'LastName': 'Knudsen', 'Affiliation': 'Section for Cell Biology and Physiology, Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Caroline Maag', 'Initials': 'CM', 'LastName': 'Kristensen', 'Affiliation': 'Section for Cell Biology and Physiology, Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Jessen', 'Affiliation': 'August Krogh Section of Human Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Pilegaard', 'Affiliation': 'Section for Cell Biology and Physiology, Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'August Krogh Section of Human Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.14171']
848,35465803,Different cardiovascular responses to exercise training in hypertensive women receiving β-blockers or angiotensin receptor blockers: A pilot study.,"AIM


To verify the influence of β-blockers or angiotensin receptor blockers on cardiovascular responses to exercise training in hypertensive post-menopausal women.
METHODS


Postmenopausal women were allocated into: healthy control group (CON;  n  = 9); angiotensin receptor blockers users (ARB;  n  = 19); and β-adrenergic blockers users (BB;  n  = 19). Before and after 12 weeks of combined (aerobic and resistance) exercise training they were evaluated by: heart rate (HR) and its variability (HRV), blood pressure (BP) under stress (Cold pressor and Stroop color tests), and ambulatorial BP and its variability.
RESULTS


In ambulatorial BP analysis only in ARB group awake systolic BP decreased ( p  = .011; ARB: From 122 ± 11 to 117 ± 9; BB: From 118 ± 7 to 114 ± 5; CON: From 121 ± 7 to 127 ± 11 mmHg). There were time effects in BP reactivity to stress, where BP reactivity after Stroop color and Cold pressor test decreased in all groups. In BP variability analysis, only BB group has significative decreased values in systolic SD24 ( p  = .007; ΔARB = -0.3 ± 2.0; ΔBB = -1.3 ± 2.0; ΔCON = 0.8 ± 1.7 mmHg) and SDdn ( p  = .006; ΔARB = -0.2 ± 1.6; ΔBB = -1.3 ± 2.0; ΔCON = 0.4 ± 2.1 mmHg). HRV analysis demonstrated that post-training, only in BB group LF/HF decreased ( p  = .001; ΔARB = 0.1 ± 0.8; ΔBB = -0.4 ± 1.5; ΔCON = 1.0 ± 1.7).
CONCLUSION


ARB present pronounced responses in awake ambulatorial systolic BP, while β-blockers users present greater responses in BP variability. Besides that, exercise can mitigate BP reactivity to stress with no differences between groups. Lastly, there were no major differences in HRV.
TRIAL REGISTRY AT “CLINICALTRIALS.GOV”


NCT03529838.",2022,"HRV analysis demonstrated that post-training, only in BB group LF/HF decreased ( p  = .001; ΔARB = 0.1 ± 0.8; ΔBB = -0.4 ± 1.5; ΔCON = 1.0 ± 1.7).
","['hypertensive post-menopausal women', 'hypertensive women receiving β-blockers or', 'Postmenopausal women']","['healthy control group (CON;  n  =\xa09); angiotensin receptor blockers users (ARB;  n  =\xa019); and β-adrenergic blockers', 'angiotensin receptor blockers', 'combined (aerobic and resistance) exercise training', 'exercise training']","['awake systolic BP', 'HRV', 'awake ambulatorial systolic BP', 'systolic SD24', 'cardiovascular responses', 'heart rate (HR) and its variability (HRV), blood pressure (BP) under stress (Cold pressor and Stroop color tests), and ambulatorial BP and its variability', 'BP reactivity after Stroop color and Cold pressor test']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0242889', 'cui_str': 'Substance with adrenergic receptor antagonist mechanism of action'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0150027,"HRV analysis demonstrated that post-training, only in BB group LF/HF decreased ( p  = .001; ΔARB = 0.1 ± 0.8; ΔBB = -0.4 ± 1.5; ΔCON = 1.0 ± 1.7).
","[{'ForeName': 'Igor M', 'Initials': 'IM', 'LastName': 'Mariano', 'Affiliation': 'Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Amaral', 'Affiliation': 'Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'V Carrijo', 'Affiliation': 'Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Juliene G', 'Initials': 'JG', 'LastName': 'Costa', 'Affiliation': 'Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Mateus de L', 'Initials': 'ML', 'LastName': 'Rodrigues', 'Affiliation': 'Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Thulio M', 'Initials': 'TM', 'LastName': 'Cunha', 'Affiliation': 'Medicine Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': 'Puga', 'Affiliation': 'Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2022.2065290']
849,35461788,Earlier bedtimes and more sleep displace sedentary behavior but not moderate-to-vigorous physical activity in adolescents.,"OBJECTIVES


Correlational models suggest increased cardiometabolic risk when sleep replaces moderate-to-vigorous (but not sedentary or light) physical activity. This study tested which activity ranges are impacted by experimentally altering adolescents' bedtime.
METHOD


Adolescents completed a 3-week within-subjects crossover experiment with 5 nights of late bedtimes and 5 nights early bedtimes (6.5- and 9.5-hours sleep opportunity, respectively). Experimental condition order was randomized. Waketimes were held constant throughout to mimic school start times. Sleep and physical activity occurred in the natural environments, with lab appointments following each 5-day condition. Waist-worn accelerometers measured physical activity and sedentary behavior. Wrist-worn actigraphs confirmed sleep condition adherence. Wilcoxon tests and linear mixed effects models compared waking activity levels between conditions and across time.
RESULTS


Ninety healthy adolescents (14-17 years) completed the study. When in the early (vs. late) bedtime condition, adolescents fell asleep 1.96 hours earlier (SD = 1.08, d = 1.82, p < .0001) and slept 1.49 hours more (SD = 1.01, d = 1.74, p < .0001). They spent 1.68 and 0.32 fewer hours in sedentary behavior (SD = 1.67, d = 1.0, p < .0001) and light physical activity (SD = 0.87, d = 0.37, p = .0005), respectively. This pattern was reflected in increased proportion of waking hours spent in sedentary and light activity. Absolute and proportion of moderate-to-vigorous physical activity did not differ between conditions (d = 0.02, p = .89; d = 0.14, p = .05, respectively).
CONCLUSIONS


Inducing earlier bedtimes (allowing for healthy sleep opportunity) did not affect moderate-to-vigorous physical activity. Alternatively, later bedtimes (allowing for ≤ 6.5 hours of sleep opportunity, mimicking common adolescent school night sleep) increased sedentary behavior. Results are reassuring for the benefits of earlier bedtimes.",2022,"Absolute and proportion of moderate-to-vigorous physical activity did not differ between conditions (d = 0.02, p = .89;","['Adolescents completed a 3-week within-subjects crossover experiment with 5 nights of late bedtimes and 5 nights early bedtimes (6.5- and 9.5-hours sleep opportunity, respectively', 'Ninety healthy adolescents (14-17 years) completed the study', 'adolescents']",[],"['physical activity and sedentary behavior', 'light physical activity', 'sleep condition adherence', 'sedentary behavior', 'Sleep and physical activity', 'waking activity levels', 'Absolute and proportion of moderate-to-vigorous physical activity', 'cardiometabolic risk']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",90.0,0.0160346,"Absolute and proportion of moderate-to-vigorous physical activity did not differ between conditions (d = 0.02, p = .89;","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Krietsch', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA; Department of Psychology, St. Louis Children's Hospital, St. Louis, Missouri, USA; Department of Clinical Pediatrics, Washington University, St. Louis, Missouri, USA. Electronic address: kendra.krietsch@bjc.org.""}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Duraccio', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA; Department of Psychology, Brigham Young University, Provo, Utah, USA.""}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Saelens', 'Affiliation': ""Seattle Children's Research Institute and Departments of Pediatrics and Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Howarth', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Combs', 'Affiliation': 'Department of Psychology, University of Cincinnati College of Arts and Sciences, Cincinnati, Ohio, USA.'}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.""}]",Sleep health,['10.1016/j.sleh.2022.01.003']
850,35469070,Digital remote monitoring plus usual care versus usual care in patients treated with oral anticancer agents: the randomized phase 3 CAPRI trial.,"Strategies that individualize the care of cancer patients receiving oral anticancer agents offer opportunities to improve treatment adherence and patient care. However, the impact of digital remote monitoring systems in this setting has not been evaluated. Here, we report the results of a phase 3 trial (CAPRI, NCT02828462) to assess the impact of a nurse navigator-led program on treatment delivery for patients with metastatic cancer. Patients receiving approved oral anticancer agents were randomized (1:1) to an intervention combining a nurse navigator-led follow-up system and a web portal-smartphone application on top of usual care, or to usual symptom monitoring at the discretion of the treating oncologist, for a duration of 6 months. The primary objective included optimization of the treatment dose. Secondary objectives were grade ≥3 toxicities, patient experience, rates and duration of hospitalization, response and survival, and quality of life. In 559 evaluable patients the relative dose intensity was higher in the experimental arm (93.4% versus 89.4%, P = 0.04). The intervention improved the patient experience (Patient Assessment of Chronic Illness Care score, 2.94 versus 2.67, P = 0.01), reduced the days of hospitalization (2.82 versus 4.44 days, P = 0.02), and decreased treatment-related grade ≥3 toxicities (27.6% versus 36.9%, P = 0.02). These findings show that patient-centered care through remote monitoring of symptoms and treatment may improve patient outcomes and experience.",2022,"The intervention improved the patient experience (Patient Assessment of Chronic Illness Care score, 2.94 versus 2.67, P = 0.01), reduced the days of hospitalization (2.82 versus 4.44 days, P = 0.02), and decreased treatment-related grade ≥3 toxicities (27.6% versus 36.9%, P = 0.02).","['cancer patients receiving', 'Patients receiving approved oral anticancer agents', 'patients with metastatic cancer']","['nurse navigator-led program', 'intervention combining a nurse navigator-led follow-up system and a web portal-smartphone application on top of usual care, or to usual symptom monitoring at the discretion of the treating oncologist', 'Digital remote monitoring plus usual care versus usual care', 'oral anticancer agents']","['treatment-related grade ≥3 toxicities', 'relative dose intensity', 'grade ≥3 toxicities, patient experience, rates and duration of hospitalization, response and survival, and quality of life', 'days of hospitalization', 'patient experience (Patient Assessment of Chronic Illness Care score']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",559.0,0.0243958,"The intervention improved the patient experience (Patient Assessment of Chronic Illness Care score, 2.94 versus 2.67, P = 0.01), reduced the days of hospitalization (2.82 versus 4.44 days, P = 0.02), and decreased treatment-related grade ≥3 toxicities (27.6% versus 36.9%, P = 0.02).","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mir', 'Affiliation': 'Department of Ambulatory Cancer Care, Gustave Roussy, Villejuif, France. olivier.mir@gustaveroussy.fr.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Ferrua', 'Affiliation': 'Department of Ambulatory Cancer Care, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Fourcade', 'Affiliation': 'Department of Ambulatory Cancer Care, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Mathivon', 'Affiliation': 'Department of Ambulatory Cancer Care, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Duflot-Boukobza', 'Affiliation': 'Department of Ambulatory Cancer Care, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dumont', 'Affiliation': 'Division of Cancer Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Baudin', 'Affiliation': 'Department of Endocrine Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Division of Cancer Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Malka', 'Affiliation': 'Division of Cancer Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Division of Cancer Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pautier', 'Affiliation': 'Division of Cancer Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Division of Cancer Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Division of Cancer Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'de Botton', 'Affiliation': 'Division of Hematology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Scotté', 'Affiliation': 'Division of Interdisciplinary Patients Care Pathways (DIOPP), Gustave Roussy, Villejuif, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lemare', 'Affiliation': 'Department of Ambulatory Cancer Care, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Abbas', 'Affiliation': 'Division of Interdisciplinary Patients Care Pathways (DIOPP), Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Marilène', 'Initials': 'M', 'LastName': 'Guillet', 'Affiliation': 'Department of Ambulatory Cancer Care, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Puglisi', 'Affiliation': 'Department of Ambulatory Cancer Care, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Di Palma', 'Affiliation': 'Department of Ambulatory Cancer Care, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Minvielle', 'Affiliation': 'Division of Interdisciplinary Patients Care Pathways (DIOPP), Gustave Roussy, Villejuif, France.'}]",Nature medicine,['10.1038/s41591-022-01788-1']
851,35469036,Ligation of Intersphincteric Fistula Tract (LIFT) with or Without Injection of Bone Marrow Mononuclear Cells in the Treatment of Trans-sphincteric Anal Fistula: a Randomized Controlled Trial.,"BACKGROUND


Ligation of intersphincteric fistula tract (LIFT) is a sphincter-saving procedure used for treatment of complex anal fistula. The current study aimed to assess the outcome of local injection of bone marrow mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to healing rate, time to healing, and ultimate success rate.
METHODS


This was a prospective randomized trial on patients with trans-sphincteric anal fistula. Patients were randomly allocated to one of two equal groups: LIFT and LIFT with BM-MNC injection. The main outcome measures were healing at 10 weeks of follow-up, recurrence after healing, and complications.
RESULTS


Seventy patients (48 male and 22 female) of a mean age of 37.9 ± 10.4 years were included. The mean time to complete healing after LIFT + BM-MNCs was significantly shorter than after LIFT alone (20.5 ± 5.2 vs 28.04 ± 5.8 days; P < 0.0001). The ultimate success rates of both groups were similar (LIFT = 60% vs LIFT with BM-MNCs = 68.6%, P = 0.62). There was no significant difference in the mean operation time or complication rate between the two groups. Secondary extension and previous anal surgery were significant independent predictors of failure of healing.
CONCLUSION


LIFT combined with BM-MNC injection was associated with a shorter time to complete healing than LIFT alone. However, BM-MNC injection did not have a significant impact on the overall healing and ultimate success rate.",2022,There was no significant difference in the mean operation time or complication rate between the two groups.,"['Seventy patients (48 male and 22 female) of a mean age of 37.9\u2009±\u200910.4\xa0years were included', 'patients with trans-sphincteric anal fistula', 'Trans-sphincteric Anal Fistula']","['intersphincteric fistula tract (LIFT', 'bone marrow mononuclear cells (BM-MNCs', 'LIFT and LIFT with BM-MNC injection', 'Ligation of Intersphincteric Fistula Tract (LIFT) with or Without Injection of Bone Marrow Mononuclear Cells', 'LIFT combined with BM-MNC injection']","['healing at 10\xa0weeks of follow-up, recurrence after healing, and complications', 'healing rate, time to healing, and ultimate success rate', 'failure of healing', 'ultimate success rates', 'shorter time to complete healing', 'mean time to complete healing', 'mean operation time or complication rate', 'overall healing and ultimate success rate']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0149889', 'cui_str': 'Anorectal fistula'}]","[{'cui': 'C0341379', 'cui_str': 'Intersphincteric fistula'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70.0,0.0389781,There was no significant difference in the mean operation time or complication rate between the two groups.,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Rezk', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, 60 El-Gomhouria Street, Mansoura, 35516, Dakahlia, Egypt.'}, {'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, 60 El-Gomhouria Street, Mansoura, 35516, Dakahlia, Egypt. sameh200@hotmail.com.'}, {'ForeName': 'El Yamani', 'Initials': 'EY', 'LastName': 'Fouda', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, 60 El-Gomhouria Street, Mansoura, 35516, Dakahlia, Egypt.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Khaled', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, 60 El-Gomhouria Street, Mansoura, 35516, Dakahlia, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamed', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, 60 El-Gomhouria Street, Mansoura, 35516, Dakahlia, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Omar', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, 60 El-Gomhouria Street, Mansoura, 35516, Dakahlia, Egypt.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khafagy', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, 60 El-Gomhouria Street, Mansoura, 35516, Dakahlia, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'AbdelMawla', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, 60 El-Gomhouria Street, Mansoura, 35516, Dakahlia, Egypt.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-022-05316-x']
852,35470006,"Effectiveness and safety of electric heating moxibustion for perennial allergic rhinitis: A pilot, randomized, assessor-blind trial.","BACKGROUND


The prevalence of allergic rhinitis (AR), an inflammatory disease, is gradually increasing. Studies have reported that moxibustion is effective for treating AR. Electric heating moxibustion (EM) was developed to offer adaptable heat stimulation without the generation of smoke.
OBJECTIVES


The objective of this study was to examine the possibility of EM in treating perennial allergic rhinitis (PAR) and to assess the feasibility of using this technique on a larger scale by comparing EM with acupuncture (AC).
DESIGN


A randomized pilot study was conducted on 40 patients with PAR. Patients were randomly assigned to one of two treatment groups: EM or AC. The primary outcome measure was the change in the total nasal symptom score (TNSS) between before and after treatment. The secondary outcome measures were the changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ), nasal endoscopy index for pattern identification, pattern identification questionnaire for AR, total serum immunoglobulin E (IgE), eosinophil count, and adverse effects (AEs).
RESULTS


The results showed a statistically significant improvement in mean TNSS and RQLQ scores in both groups (p < 0.05), but no significant difference between the two groups. However, mean changes in itching and sneezing TNSS were significantly higher in the AC group. There was no significant difference in total serum IgE or eosinophil count before versus after treatment, nor was there any significant difference of three pattern subgroups between the two groups in the mean TNSS change. While the AC group reported two treatment-related AEs, there were no treatment-related AEs in the EM group.
CONCLUSION


This trial provides evidence that EM isa safe alternative treatment for patients with PAR.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03342105. Registered on 14 November 2017.",2022,"The results showed a statistically significant improvement in mean TNSS and RQLQ scores in both groups (p<0.05), but no significant difference between the two groups.","['patients with PAR', 'perennial allergic rhinitis (PAR', 'perennial allergic rhinitis', '40 patients with PAR']","['EM with acupuncture (AC', 'EM or AC', 'electric heating moxibustion', 'Electric heating moxibustion (EM']","['mean TNSS and RQLQ scores', 'rhinoconjunctivitis quality of life questionnaire (RQLQ), nasal endoscopy index for pattern identification, pattern identification questionnaire for AR, total serum immunoglobulin E (IgE), eosinophil count, and adverse effects (AEs', 'total serum IgE or eosinophil count', 'total nasal symptom score (TNSS', 'mean changes in itching and sneezing TNSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}]",40.0,0.07241,"The results showed a statistically significant improvement in mean TNSS and RQLQ scores in both groups (p<0.05), but no significant difference between the two groups.","[{'ForeName': 'Hyo-Rim', 'Initials': 'HR', 'LastName': 'Jo', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Dongguk University Graduate School, Seoul, Republic of Korea. Electronic address: sunny4396@hanmail.net.'}, {'ForeName': 'Won-Suk', 'Initials': 'WS', 'LastName': 'Sung', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: 1984sws@hanmail.net.'}, {'ForeName': 'Chan-Yung', 'Initials': 'CY', 'LastName': 'Jung', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Goyang, Republic of Korea. Electronic address: yyoung81@hanmail.net.'}, {'ForeName': 'Chi-Yeon', 'Initials': 'CY', 'LastName': 'Lim', 'Affiliation': 'Department of Biostatistics, College of Medicine, Dongguk University, Goyang, Republic of Korea. Electronic address: rachun@hanmail.net.'}, {'ForeName': 'Seung-Deok', 'Initials': 'SD', 'LastName': 'Lee', 'Affiliation': 'Institute of Oriental Medicine, College of Korean Medicine, Dongguk University, Goyang, Republic of Korea. Electronic address: chunkman@dongguk.edu.'}, {'ForeName': 'Seung-Ug', 'Initials': 'SU', 'LastName': 'Hong', 'Affiliation': 'Department of Ophthalmology, Otolaryngology and Dermatology, Dongguk University Ilsan Oriental Hospital, Gyeonggi-do, Republic of Korea. Electronic address: heenthsu@hanmail.net.'}, {'ForeName': 'Kyung-Ho', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital, Goyang, Republic of Korea. Electronic address: omdkkh@hanmail.net.'}, {'ForeName': 'Eun-Jung', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of Korea. Electronic address: hanijjung@naver.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2022.102835']
853,35473594,Effectiveness of workshops to teach a home-based exercise program (BEST at Home) for preventing falls in community-dwelling people aged 65 years and over: a pragmatic randomised controlled trial.,"BACKGROUND


Falls are a significant public health issue. There is strong evidence that exercise can prevent falls and the most effective programs are those that primarily involve balance and functional exercises, however uptake of such programs is low. Exercise prescribed during home visits by health professionals can prevent falls however this strategy would be costly to deliver at scale. We developed a new approach to teach home exercise through group-based workshops delivered by physiotherapists. The primary aim was to determine the effect of this approach on the rate of falls among older community-dwelling people over 12 months. Secondary outcomes included the proportion of people falling, fear of falling, physical activity, lower limb strength, balance and quality of life.
METHODS


A randomised controlled trial was conducted among community-dwelling people aged ≥65 in New South Wales, Australia. Participants were randomised to either the intervention group (exercise targeting balance and lower limb strength) or control group (exercise targeting upper limb strength).
RESULTS


A total of 617 participants (mean age 73 years, +SD 6, 64% female) were randomly assigned to the intervention group (n = 307) or control group (n = 310). There was no significant between-group difference in the rate of falls (IRR 0.91, 95% CI 0.64 to 1.29, n = 579, p = 0.604) or the number of participants reporting one or more falls (IRR 0.99, 95% CI 0.76 to 1.29, n = 579, p = 0.946) during 12 month follow-up. A significant improvement in the intervention group compared to control group was found for fear of falling at 3, 6 and 12 months (mean difference 0.50, 95% CI 0.2 to 0.8, p = 0.004; 0.39, 95% CI 0.001 to 0.8, p = 0.049; 0.46, 95% CI 0.006 to 0.9, p = 0.047, respectively), and gait speed at 3 months (mean difference 0.09 s, 95% CI 0.003 to 0.19, p = 0.043). No statistically significant between-group differences were detected for the other secondary outcomes.
CONCLUSIONS


There was no significant intervention impact on the rate of falls, but the program significantly reduced fear of falling and improved gait speed. Other exercise delivery approaches are needed to ensure an adequate intensity of balance and strength challenge and dose of exercise to prevent falls.",2022,"There was no significant intervention impact on the rate of falls, but the program significantly reduced fear of falling and improved gait speed.","['older community-dwelling people over 12\u2009months', '617 participants (mean age 73\u2009years, +SD 6, 64% female', 'community-dwelling people aged ≥65 in New South Wales, Australia', 'community-dwelling people aged 65\u2009years and over']","['intervention group (exercise targeting balance and lower limb strength) or control group (exercise targeting upper limb strength', 'workshops to teach a home-based exercise program (BEST at Home']","['gait speed', 'rate of falls', 'number of participants reporting one or more falls', 'proportion of people falling, fear of falling, physical activity, lower limb strength, balance and quality of life', 'fear of falling', 'fear of falling and improved gait speed']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",617.0,0.0448782,"There was no significant intervention impact on the rate of falls, but the program significantly reduced fear of falling and improved gait speed.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Health Promotion Service, Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia. amanda.bates@health.nsw.gov.au.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Furber', 'Affiliation': 'Health Promotion Service, Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van den Dolder', 'Affiliation': 'Primary Care and Community Health, Nepean Blue Mountains Local Health District, Kingswood, NSW, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ginn', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kershaw', 'Affiliation': 'Health Promotion Service, Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franco', 'Affiliation': 'Health Promotion Service, Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Chittenden', 'Affiliation': 'Department of Physiotherapy, Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, NSW, Australia.'}]",BMC geriatrics,['10.1186/s12877-022-03050-2']
854,35475921,Effects of an external pneumatic compression device vs static compression garment on peripheral circulation and markers of sports performance and recovery.,"PURPOSE


To identify the effects of a single 30 min partial lower leg external pneumatic compression (EPC) treatment compared to a static compression (SC) garment or a no treatment control (CTL) on markers of recovery and performance following a muscle damaging protocol.
METHODS


Thirty healthy, active males (23 ± 3 years; 180.2 ± 9.0 cm; 81.6 ± 11.3 kg) performed 100 drop jumps from a 0.6 m box followed by a randomized, single 30 min treatment of either a partial lower leg EPC device worn below the knee and above the ankle (110 mmHg), SC garment (20-30 mmHg) covering the foot and calf just below the knee, or no treatment CTL, and then returned 24 and 48 h later. Participants were assessed for measures of muscle soreness, fatigue, hemodynamics, blood lactate, muscle thickness, circumferences, and performance assessments.
RESULTS


The drop jump protocol significantly increased muscle soreness (p < 0.001), fatigue (p < 0.001), blood flow (p < 0.001), hemoglobin (p < 0.001), and muscle oxygen saturation (SMO 2 ; p < 0.001). Countermovement jump and squat jump testing completed after treatment with either EPC, SC, or CTL revealed no differences for jump height between any condition. However, EPC treatment maintained consistent braking force and propulsive power measures across all timepoints for countermovement jump testing. EPC and SC treatment also led to better maintenance of squat jump performance for average relative propulsive force and power variables at 24 and 48 h compared to CTL.
CONCLUSIONS


A single 30 min partial leg EPC treatment may lead to more consistent jump performance following a damaging bout of exercise.",2022,"EPC and SC treatment also led to better maintenance of squat jump performance for average relative propulsive force and power variables at 24 and 48 h compared to CTL.
","['Thirty healthy, active males\xa0(23\u2009±\u20093\xa0years; 180.2\u2009±\u20099.0\xa0cm; 81.6\u2009±\u200911.3\xa0kg']","['EPC and SC', 'external pneumatic compression device vs static compression garment', 'partial lower leg EPC device worn below the knee and above the ankle (110\xa0mmHg), SC garment (20-30\xa0mmHg) covering the foot and calf just below the knee, or no treatment CTL', 'EPC, SC, or CTL', 'single 30\xa0min partial lower leg external pneumatic compression (EPC', 'static compression (SC) garment or a no treatment control (CTL']","['fatigue', 'peripheral circulation and markers of sports performance and recovery', 'muscle oxygen saturation', 'blood flow', 'hemoglobin ', 'muscle soreness', 'muscle soreness, fatigue, hemodynamics, blood lactate, muscle thickness, circumferences, and performance assessments', 'squat jump performance']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0009072', 'cui_str': 'Garments'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",30.0,0.0966314,"EPC and SC treatment also led to better maintenance of squat jump performance for average relative propulsive force and power variables at 24 and 48 h compared to CTL.
","[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Blumkaitis', 'Affiliation': 'Department of Kinesiology, College of Science, Technology, and Health, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Moon', 'Affiliation': 'Department of Kinesiology, College of Science, Technology, and Health, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, USA.'}, {'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Ratliff', 'Affiliation': 'Department of Kinesiology, College of Science, Technology, and Health, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Stecker', 'Affiliation': 'Department of Kinesiology, College of Science, Technology, and Health, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, USA.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Richmond', 'Affiliation': 'Department of Kinesiology, College of Science, Technology, and Health, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, USA.'}, {'ForeName': 'Kyle L', 'Initials': 'KL', 'LastName': 'Sunderland', 'Affiliation': 'Department of Kinesiology, College of Science, Technology, and Health, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, USA.'}, {'ForeName': 'Chad M', 'Initials': 'CM', 'LastName': 'Kerksick', 'Affiliation': 'Department of Kinesiology, College of Science, Technology, and Health, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Martin', 'Affiliation': 'DeBusk College of Osteopathic Medicine, Lincoln Memorial University at Knoxville, 9737 Cogdill Road, Knoxville, TN, USA.'}, {'ForeName': 'Petey W', 'Initials': 'PW', 'LastName': 'Mumford', 'Affiliation': 'Department of Kinesiology, College of Science, Technology, and Health, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, USA. pmumford@lindenwood.edu.'}]",European journal of applied physiology,['10.1007/s00421-022-04953-z']
855,35482016,"DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial.","BACKGROUND


Mild appendicitis may resolve spontaneously. The use of CT may lead to an overdiagnosis of uncomplicated appendicitis. The aims of this study were to examine whether early imaging results in more patients being diagnosed with acute appendicitis than initial observation, and to study the safety and feasibility of score-based observation compared with imaging in patients with equivocal signs of appendicitis.
METHODS


Patients with suspected appendicitis with symptoms for fewer than 24 h and an Adult Appendicitis Score of 11-15 were eligible for this trial. After exclusions, patients were randomized openly into two equal-sized groups: imaging and observation. Patients in the imaging group had ultrasound imaging followed by CT when necessary, whereas those in the observation group were reassessed after 6-8 h with repeated scoring and managed accordingly. The primary outcome was the number of patients requiring treatment for acute appendicitis within 30 days.
RESULTS


Ninety-three patients were randomized to imaging and 92 to observation; after exclusions, 93 and 88 patients respectively were analysed. In the imaging group, more patients underwent treatment for acute appendicitis than in the observation group: 72 versus 57 per cent (difference 15 (95 per cent c.i. 1 to 29) per cent). This suggests that patients with spontaneously resolving appendicitis were not diagnosed or treated in the observation group. Some 55 per cent of patients in the observation group did not need diagnostic imaging within 30 days after randomization. There was no difference in the number of patients diagnosed with complicated appendicitis (4 versus 2 per cent) or negative appendicectomies (1 versus 1 per cent) in the imaging and observation groups.
CONCLUSION


Score-based observation of patients with early equivocal appendicitis results in fewer patients requiring treatment for appendicitis. Registration number: NCT02742402 (http://www.clinicaltrials.gov).",2022,"There was no difference in the number of patients diagnosed with complicated appendicitis (4 versus 2 per cent) or negative appendicectomies (1 versus 1 per cent) in the imaging and observation groups.
","['Patients with suspected appendicitis with symptoms for fewer than 24\u2005h and an Adult Appendicitis Score of 11-15 were eligible for this trial', 'patients with equivocal signs of appendicitis', 'patients with spontaneously resolving appendicitis', 'Ninety-three patients were randomized to imaging and 92 to observation; after exclusions, 93 and 88 patients respectively were analysed', 'patients being diagnosed with acute appendicitis than initial observation']","['DIAgnostic iMaging or Observation', 'CT']","['number of patients diagnosed with complicated appendicitis', 'number of patients requiring treatment for acute appendicitis', 'negative appendicectomies', 'acute appendicitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332241', 'cui_str': 'Equivocal'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1632842', 'cui_str': 'Complicated appendicitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",93.0,0.266342,"There was no difference in the number of patients diagnosed with complicated appendicitis (4 versus 2 per cent) or negative appendicectomies (1 versus 1 per cent) in the imaging and observation groups.
","[{'ForeName': 'Kirsi S', 'Initials': 'KS', 'LastName': 'Lastunen', 'Affiliation': 'Department of Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ari K', 'Initials': 'AK', 'LastName': 'Leppäniemi', 'Affiliation': 'Department of Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Panu J', 'Initials': 'PJ', 'LastName': 'Mentula', 'Affiliation': 'Department of Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}]",The British journal of surgery,['10.1093/bjs/znac120']
856,35483627,Assessing the post-treatment therapeutic effect of tongxie in irritable bowel syndrome: A randomized controlled trial.,"Diarrhea predominant irritable bowel syndrome (IBS) is a highly relapsing gastrointestinal disorder decreasing the quality of life. Existing studies indicated that the therapeutic effects maintained for a period of time after the treatments were discontinued (post-treatment therapeutic effects or PTTE). In this study, we aim to assess the PTTE of tongxie. We performed a multiple center, controlled, double blind study of patients with IBS randomized to tongxie (n = 120) or placebo (n = 120) for 4 weeks and followed up for 57 weeks. The primary outcomes were abdominal pains and stool consistency. The secondary outcomes were pain frequency and stool frequency. Tertiary outcomes were adverse effects and global overall symptom. The outcome data were collected at days 1, 2, 3, weeks 1 and 4 during the treatment and at days 1, 2, 3, until week 57 during the post-treatment. Significantly more patients receiving tongxie were clinical responders to the primary and secondary endpoints from day 1 until the end of the treatment. The positive effects of tongxie were maintained until 17-25 weeks after tongxie was discontinued. The relapse-free probabilities in the tongxie group were significantly higher than those in the placebo group (P < .001). Twenty-five weeks after the therapies were discontinued could be considered as IBS natural history. During this period, an average of 53.8-56.3% of patients (pool tongxie and placebo data together) had IBS symptoms (pain scale ≥ 3, stool consistency ≥ 5). In particular, at the end of this study (week 61), 145 (54.2%) patients had IBS symptoms. Our results provide clinical insights into efficient and cost-effective management of refractory IBS, and lend support to the IBS management that the selection of a therapy should consider both its effectiveness during treatment and its PTTE after the treatment.",2022,The relapse-free probabilities in the tongxie group were significantly higher than those in the placebo group (P <.001).,"['patients with IBS randomized to tongxie (n=120) or', 'Diarrhea predominant irritable bowel syndrome (IBS', 'irritable bowel syndrome']","['placebo', 'tongxie']","['adverse effects and global overall symptom', 'abdominal pains and stool consistency', 'relapse-free probabilities', 'pain frequency and stool frequency', 'IBS symptoms', 'IBS symptoms (pain scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",,0.147548,The relapse-free probabilities in the tongxie group were significantly higher than those in the placebo group (P <.001).,"[{'ForeName': 'Yaoliang', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Department of Gastroenterology, Beijing Xuanwu Hospital of Chinese Medicine, 8 Wanming Rd., Beijing 100050, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""School of Education, Saint Mary's University of Minnesota, 700 Terrace Heights, Winona, MN 55987, USA.""}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Liberty Rd., Wuhan, Hubei 430022, China.'}, {'ForeName': 'Yujin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Liberty Rd., Wuhan, Hubei 430022, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastroenterology, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Provincial Second Hospital of Chinese Medicine, 23 Nanhu Rd., Nanjing 210017, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Internal Medicine, Jiangsu Provincial Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, 155 Hanzhong Rd., Nanjing 210029, China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'The State Key Laboratory Cultivation Base for TCM Quality and Efficacy, The School of Medicine and Life Sciences, Nanjing University of Chinese Medicine, 138 Xianlin Road, Nanjing 210023, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, Beijing Xuanwu Hospital of Chinese Medicine, 8 Wanming Rd., Beijing 100050, China.'}, {'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Liberty Rd., Wuhan, Hubei 430022, China.'}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Liberty Rd., Wuhan, Hubei 430022, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Zuo', 'Affiliation': 'Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Liberty Rd., Wuhan, Hubei 430022, China.'}, {'ForeName': 'Zhexing', 'Initials': 'Z', 'LastName': 'Shou', 'Affiliation': 'Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Liberty Rd., Wuhan, Hubei 430022, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Liberty Rd., Wuhan, Hubei 430022, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Provincial Second Hospital of Chinese Medicine, 23 Nanhu Rd., Nanjing 210017, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Provincial Second Hospital of Chinese Medicine, 23 Nanhu Rd., Nanjing 210017, China.'}, {'ForeName': 'Zhengyan', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Provincial Second Hospital of Chinese Medicine, 23 Nanhu Rd., Nanjing 210017, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zang', 'Affiliation': 'The Macrohard Institute of Health, 231 North Ave, Battle Creek, MI 49017, USA.'}, {'ForeName': 'Huisuo', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'The Macrohard Institute of Health, 231 North Ave, Battle Creek, MI 49017, USA.'}, {'ForeName': 'Zongxiang', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'The State Key Laboratory Cultivation Base for TCM Quality and Efficacy, The School of Medicine and Life Sciences, Nanjing University of Chinese Medicine, 138 Xianlin Road, Nanjing 210023, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The American Academy of Acupuncture and Oriental Medicine, 1925 W County Rd B2, Roseville, MN 55113. Electronic address: Doctorliqian@gmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'The Macrohard Institute of Health, 231 North Ave, Battle Creek, MI 49017, USA. Electronic address: jxiao@macrohardinstitute.org.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2022.102839']
857,35445820,Effect of dapagliflozin on kidney and cardiovascular outcomes by baseline KDIGO risk categories: a post hoc analysis of the DAPA-CKD trial.,"AIMS/HYPOTHESIS


In the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial, dapagliflozin reduced the risks of progressive kidney disease, hospitalised heart failure or cardiovascular death, and death from all causes in patients with chronic kidney disease (CKD) with or without type 2 diabetes. Patients with more severe CKD are at higher risk of kidney failure, cardiovascular events and all-cause mortality. In this post hoc analysis, we assessed the efficacy and safety of dapagliflozin according to baseline Kidney Disease Improving Global Outcomes (KDIGO) risk categories.
METHODS


DAPA-CKD was a double-blind, placebo-controlled trial that randomised patients with an eGFR of 25-75 ml min -1  [1.73 m] -2  and urinary albumin/creatinine ratio (UACR) of ≥22.6 and <565.0 mg/mmol (200-5000 mg/g) to dapagliflozin 10 mg/day or placebo. The primary endpoint was a composite of ≥50% reduction in eGFR, end-stage kidney disease (ESKD), and death from a kidney or cardiovascular cause. Secondary endpoints included a kidney composite (≥50% reduction in eGFR, ESKD and death from a kidney cause), a cardiovascular composite (heart failure hospitalisation or cardiovascular death), and death from all causes. We used Cox proportional hazards regression analyses to assess relative and absolute effects of dapagliflozin across KDIGO risk categories.
RESULTS


Of the 4304 participants in the DAPA-CKD study, 619 (14.4%) were moderately high risk, 1349 (31.3%) were high risk and 2336 (54.3%) were very high risk when categorised by KDIGO risk categories at baseline. Dapagliflozin reduced the hazard of the primary composite (HR 0.61; 95% CI 0.51, 0.72) and secondary endpoints consistently across KDIGO risk categories (all p for interaction >0.09). Absolute risk reductions for the primary outcome were also consistent irrespective of KDIGO risk category (p for interaction 0.26). Analysing patients with and without type 2 diabetes separately, the relative risk reduction with dapagliflozin in terms of the primary outcome was consistent across subgroups of KDIGO risk categories. The relative frequencies of adverse events and serious adverse events were also similar across KDIGO risk categories.
CONCLUSION/INTERPRETATIONS


The consistent benefits of dapagliflozin on kidney and cardiovascular outcomes across KDIGO risk categories indicate that dapagliflozin is efficacious and safe across a wide spectrum of kidney disease severity.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03036150.
FUNDING


The study was funded by AstraZeneca.",2022,Absolute risk reductions for the primary outcome were also consistent irrespective of KDIGO risk category (p for interaction 0.26).,"['randomised patients with an eGFR of 25-75\xa0ml\xa0min -1  [1.73\xa0m] -2  and urinary albumin/creatinine ratio (UACR) of ≥22.6 and <565.0\xa0mg/mmol (200-5000\xa0mg/g) to', 'patients with chronic kidney disease (CKD) with or without type 2 diabetes']","['placebo', 'dapagliflozin', 'Dapagliflozin', 'dapagliflozin 10\xa0mg/day or placebo']","['kidney composite (≥50% reduction in eGFR, ESKD and death from a kidney cause), a cardiovascular composite (heart failure hospitalisation or cardiovascular death), and death from all causes', 'composite of ≥50% reduction in eGFR, end-stage kidney disease (ESKD), and death from a kidney or cardiovascular cause', 'kidney and cardiovascular outcomes', 'kidney failure, cardiovascular events', 'relative frequencies of adverse events and serious adverse events', 'efficacy and safety', 'Absolute risk reductions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0567349', 'cui_str': 'mg/mmol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.54085,Absolute risk reductions for the primary outcome were also consistent irrespective of KDIGO risk category (p for interaction 0.26).,"[{'ForeName': 'Simke W', 'Initials': 'SW', 'LastName': 'Waijer', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Department of Medicine, Division of Nephrology, University Health Network and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jongs', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center Munich, Germany, and Department of Medicine 4, University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'The National Medical Science and Nutrition Institute Salvador Zubiran, Mexico City, Mexico.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefansson', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. h.j.lambers.heerspink@umcg.nl.'}]",Diabetologia,['10.1007/s00125-022-05694-6']
858,35445819,Sleep deprivation prevents counterregulatory adaptation to recurrent hypoglycaemia.,"AIMS/HYPOTHESIS


Attenuated counterregulation after recurrent hypoglycaemia is a major complication of diabetes treatment. As there is previous evidence for the relevance of sleep in metabolic control, we assessed the acute contribution of sleep to the counterregulatory adaptation to recurrent hypoglycaemia.
METHODS


Within a balanced crossover design, 15 healthy, normal-weight male participants aged 18-35 years underwent three hyperinsulinaemic-hypoglycaemic clamps with a glucose nadir of 2.5 mmol/l, under two experimental conditions, sleep and sleep deprivation. Participants were exposed to two hypoglycaemic episodes, followed by a third hypoglycaemic clamp after one night of regular 8 h sleep vs sleep deprivation. The counterregulatory response of relevant hormones (glucagon, growth hormone [GH], ACTH, cortisol, adrenaline [epinephrine] and noradrenaline [norepinephrine]) was measured, and autonomic and neuroglycopenic symptoms were assessed.
RESULTS


Sleep deprivation compared with sleep dampened the adaptation to recurrent hypoglycaemia for adrenaline (p=0.004), and this pattern also emerged in an overall analysis including adrenaline, GH and glucagon (p=0.064). After regular sleep, the counterregulatory responses of adrenaline (p=0.005), GH (p=0.029) and glucagon (p=0.009) were attenuated during the 3rd clamp compared with the 1st clamp, but were preserved after sleep deprivation (all p>0.225). Neuroglycopenic and autonomic symptoms during the 3rd clamp compared with the 1st clamp were likewise reduced after sleep (p=0.005 and p=0.019, respectively). In sleep deprivation, neuroglycopenic symptoms increased (p=0.014) and autonomic symptoms were unchanged (p=0.859).
CONCLUSIONS/INTERPRETATION


The counterregulatory adaptation to recurrent hypoglycaemia is compromised by sleep deprivation between hypoglycaemic episodes, indicating that sleep is essential for the formation of a neurometabolic memory, and may be a potential target of interventions to treat hypoglycaemia unawareness syndrome.",2022,"In sleep deprivation, neuroglycopenic symptoms increased (p=0.014) and autonomic symptoms were unchanged (p=0.859).
","['15 healthy, normal-weight male participants aged 18-35\xa0years underwent three']","['hyperinsulinaemic-hypoglycaemic clamps with a glucose nadir of 2.5\xa0mmol/l, under two experimental conditions, sleep and sleep deprivation', 'Sleep deprivation', 'hypoglycaemic clamp after one night of regular 8\xa0h sleep vs sleep deprivation']","['autonomic and neuroglycopenic symptoms', 'counterregulatory responses of adrenaline', 'Neuroglycopenic and autonomic symptoms', 'autonomic symptoms', 'sleep deprivation, neuroglycopenic symptoms', 'GH (p=0.029) and glucagon', 'counterregulatory response of relevant hormones (glucagon, growth hormone [GH], ACTH, cortisol, adrenaline [epinephrine] and noradrenaline [norepinephrine', 'recurrent hypoglycaemia']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.0765449,"In sleep deprivation, neuroglycopenic symptoms increased (p=0.014) and autonomic symptoms were unchanged (p=0.859).
","[{'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Meyhöfer', 'Affiliation': 'Institute for Endocrinology & Diabetes, University of Lübeck, Lübeck, Germany. svenja.meyhoefer@uni-luebeck.de.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Dembinski', 'Affiliation': 'Institute for Endocrinology & Diabetes, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Schultes', 'Affiliation': 'Metabolic Center St Gallen, FriendlyDocs Ltd, St Gallen, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Born', 'Affiliation': 'German Center for Diabetes Research (DZD), München-Neuherberg, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Wilms', 'Affiliation': 'Institute for Endocrinology & Diabetes, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Lehnert', 'Affiliation': 'University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Hallschmid', 'Affiliation': 'German Center for Diabetes Research (DZD), München-Neuherberg, Germany.'}, {'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Meyhöfer', 'Affiliation': 'Institute for Endocrinology & Diabetes, University of Lübeck, Lübeck, Germany.'}]",Diabetologia,['10.1007/s00125-022-05702-9']
859,35447502,Calcium chloride for the prevention of uterine atony during cesarean delivery: A pilot randomized controlled trial and pharmacokinetic study.,"STUDY OBJECTIVE


To assess the feasibility, patient tolerance, pharmacokinetics, and potential effectiveness of a randomized controlled trial protocol investigating intravenous calcium chloride for the prevention of uterine atony during cesarean delivery.
DESIGN


Double-blind, randomized controlled pilot trial with nested population pharmacokinetic analysis.
SETTING


This study was performed at Lucile Packard Children's Hospital, from August 2018 to September 2019.
PATIENTS


Forty patients with at least two risk factors for uterine atony at the time of cesarean delivery.
INTERVENTIONS


One gram of intravenous calcium chloride (n = 20 patients) or a saline placebo control (n = 20 patients), in addition to standard care with oxytocin, upon umbilical cord clamping.
MEASUREMENTS


The primary efficacy-related outcome was the presence of uterine atony defined as the use of a second-line uterotonic medication, surgical interventions for atony, or hemorrhage with blood loss >1000 mL. Blood loss, uterine tone numerical rating scores, serial venous blood calcium levels, hemodynamics, and potential side effects were also assessed.
MAIN RESULTS


The study protocol proved feasible. The incidence of atony was 20% in parturients who received calcium compared to 50% in the placebo group (relative risk 0.38, P = 0.07, 95% CI 0.15-1.07, NNT 3.3). Calcium recipients tolerated the drug infusion well, with no adverse events and an equal incidence of potential side effects in the calcium and placebo groups. Ionized calcium concentration rose significantly in all patients who received calcium infusion, from baseline 1.18 mmol/L to peak levels 1.50-1.60 mmol/L. One-compartment population pharmacokinetics established clearance of 0.93 (95% CI 0.63-1.52) L/min and volume of distribution 76 (95% CI 49-94) L.
CONCLUSIONS


In this pilot study, investigators found that intravenous calcium chloride was well-tolerated by the 20 patients assigned to receive the study drug and may be effective in prevention of uterine atony. A 1-g dose was sufficient to substantially increase calcium levels without any critically elevated lab values or concern for adverse side effects. These encouraging findings warrant further investigation of calcium as a novel agent to prevent uterine atony with an adequately powered clinical trial. Clinical trial registry NCT03867383 https://clinicaltrials.gov/ct2/show/NCT03867383.",2022,"The incidence of atony was 20% in parturients who received calcium compared to 50% in the placebo group (relative risk 0.38, P = 0.07, 95% CI 0.15-1.07, NNT 3.3).","['Forty patients with at least two risk factors for uterine atony at the time of cesarean delivery', ""This study was performed at Lucile Packard Children's Hospital, from August 2018 to September 2019"", 'uterine atony during cesarean delivery']","['intravenous calcium chloride', 'calcium chloride', 'Calcium', 'saline placebo control', 'standard care with oxytocin, upon umbilical cord clamping', 'Calcium chloride', 'placebo']","['potential side effects', 'incidence of atony', 'presence of uterine atony defined as the use of a second-line uterotonic medication, surgical interventions for atony, or hemorrhage with blood loss >1000 mL. Blood loss, uterine tone numerical rating scores, serial venous blood calcium levels, hemodynamics, and potential side effects', 'Ionized calcium concentration', 'calcium levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0042135', 'cui_str': 'Uterine inertia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0006686', 'cui_str': 'Calcium Chloride'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0405737', 'cui_str': 'Umbilical cord clamping'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042135', 'cui_str': 'Uterine inertia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",40.0,0.567708,"The incidence of atony was 20% in parturients who received calcium compared to 50% in the placebo group (relative risk 0.38, P = 0.07, 95% CI 0.15-1.07, NNT 3.3).","[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Ansari', 'Affiliation': 'Stanford University, Stanford, CA 94305, United States of America. Electronic address: jansari@stanford.edu.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kalariya', 'Affiliation': 'Virginia Mason Medical Center, Seattle, WA 98101, United States of America.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Carvalho', 'Affiliation': 'Stanford University, Stanford, CA 94305, United States of America.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Flood', 'Affiliation': 'Stanford University, Stanford, CA 94305, United States of America.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': 'Stanford University, Stanford, CA 94305, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Riley', 'Affiliation': 'Stanford University, Stanford, CA 94305, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2022.110796']
860,35451239,Effects of skin-to-skin contact on afterpain and postpartum hemorrhage: A randomized controlled trial.,"This study determined the effects of skin-to-skin contact between the mother and the infant during the third stage of labor on postpartum hemorrhage and pain. This assessor-blinded randomized controlled trial was conducted with primiparous women. Skin-to-skin contact interventions between the infants and their mothers occurred for 30 min after birth (n = 34), whereas the infants in the control group were provided routine care (n = 34). Data were gathered using a Personal Information Form, the Visual Analog Scale-Pain, postpartum bleeding follow-up bags, and records of blood oxytocin and beta endorphin levels. There was no significant difference in beta-endorphin levels in both groups (p = 0.771), whereas it was determined that the 30th min oxytocin level was significantly higher in the intervention group (The Visual Analog Scale-Pain score at the postpartum sixth hour was significantly lower in the intervention group. It was found that skin-to-skin contact made at the third stage of labor reduced the amount of postpartum hemorrhage. The results of this study suggested that skin-to-skin contact intervention may have beneficial effects on postpartum pain and postpartum hemorrhage in the early postpartum period.",2022,"There was no significant difference in beta endorphin levels in both groups (p: 0.771), whereas it was determined that the 30th min oxytocin level was significantly higher in the intervention group (Intervention group:225,81±256,87; Control group:152,76±181,70; p: 0.043).","['Afterpain and Postpartum Hemorrhage', 'primiparous women']","['Skin-to-Skin Contact', 'Skin-to-skin contact interventions']","['oxytocin level', 'postpartum pain and postpartum hemorrhage', 'Visual Analog Scale-Pain, postpartum bleeding follow-up bags and records of blood oxytocin and beta-endorphin levels', 'Visual Analog Scale-Pain score', 'postpartum hemorrhage', 'postpartum hemorrhage and pain', 'beta endorphin levels']","[{'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0848200', 'cui_str': 'Afterbirth pain'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005210', 'cui_str': 'Beta endorphin'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",,0.0369067,"There was no significant difference in beta endorphin levels in both groups (p: 0.771), whereas it was determined that the 30th min oxytocin level was significantly higher in the intervention group (Intervention group:225,81±256,87; Control group:152,76±181,70; p: 0.043).","[{'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Aydin Kartal', 'Affiliation': 'Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Kaya', 'Affiliation': ""Department of Obstetrics and Gynaecology, Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Yazici', 'Affiliation': 'Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Engin', 'Affiliation': ""Department of Obstetrics and Gynaecology, Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Resul', 'Initials': 'R', 'LastName': 'Karakus', 'Affiliation': ""Department of Obstetrics and Gynaecology, Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}]",Nursing & health sciences,['10.1111/nhs.12945']
861,35452194,Co-occurring Depression and Suicidal Ideation in Opioid Use Disorder: Prevalence and Response During Treatment With Buprenorphine-Naloxone and Injection Naltrexone.,"Objective:  The concept of ""deaths of despair"" (suicide, overdose, and alcohol-related liver disease) highlights the importance of detecting and understanding the course of co-occurring depression in patients with opioid use disorder (OUD).
Methods:  In a 24-week trial of 570 patients with  DSM-5 -defined OUD randomized to buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX) from January 2014 to January 2017, the prevalence of depression (assessed with Hamilton Depression Rating Scale [HDRS]) was examined at baseline and after 4 weeks of treatment, and the association between depression and relapse to opioid use was explored using logistic regression.
Results:  Among 473 patients who initiated medication, 14.2% (67/473) had moderate/severe depression (HDRS ≥ 17) and 34.9% (165/473) had mild depression (8 ≤ HDRS ≤ 16) at baseline. Patients with moderate/severe depression had more frequent histories of anxiety disorders and suicidal ideation. After 4 weeks of treatment, approximately two-thirds of participants with depression either responded (HDRS reduced ≥ 50% from baseline) or remitted (HDRS ≤ 7), with no significant differences between medication treatment groups. Those with moderate/severe depression were less likely to remit (52.8%; 28/53) compared to those with mild depression (76%; 98/129) at week 4 (OR = 0.43, 95% CI = 0.21-0.89,  P  = .02). Further, those who remitted at week 4 had lower, but not significantly different, risk of relapse to opioids compared to those who did not remit (OR = 0.55, 95% CI = 0.28-1.08,  P  = .08).
Conclusions:  Depression is common among patients with OUD and often remits after initiation of BUP-NX or XR-NTX, although when it does not remit it may be associated with worse opioid use outcome. Depression should be screened and followed during initiation of treatment and, when it does not remit, specific depression treatment should be considered.
Trial Registration:  ClinicalTrials.gov identifier: NCT02032433.",2022,"Further, those who remitted at week 4 had lower, but not significantly different, risk of relapse to opioids compared to those who did not remit (OR = 0.55, 95% CI = 0.28-1.08,  P  = .08).
","['Patients with moderate/severe depression', '473 patients who initiated medication, 14.2', 'patients with opioid use disorder (OUD', '570 patients with  DSM-5 -defined OUD randomized to', 'patients with OUD']","['buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX', 'Buprenorphine-Naloxone and Injection Naltrexone']","['mild depression', 'moderate/severe depression', 'anxiety disorders and suicidal ideation', 'risk of relapse to opioids', 'prevalence of depression (assessed with Hamilton Depression Rating Scale [HDRS', 'severe depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0588006', 'cui_str': 'Mild depression'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}]",570.0,0.137674,"Further, those who remitted at week 4 had lower, but not significantly different, risk of relapse to opioids compared to those who did not remit (OR = 0.55, 95% CI = 0.28-1.08,  P  = .08).
","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Na', 'Affiliation': 'Department of Psychiatry, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, New York, New York.'}]",The Journal of clinical psychiatry,['10.4088/JCP.21m14140']
862,35459970,Effects of Biological Determinism on Beliefs and Attitudes About Transgender People: Psychological Essentialism and Biased Assimilation.,"This experimental study examined the effects of biological attributions on individuals' beliefs and attitudes toward transgender people and the moderating role of right-wing authoritarianism (RWA). We randomly assigned 183 Chinese university students (men: n = 85, women: n = 98) to read one of three fictitious articles. The first article suggested that transgender identity was causally linked to biology (biological determinist condition), the second one highlighted the interplay between biological and environmental factors (epigenetic condition), whereas the third article did not mention the origins of transgender identity (control condition). Consistent with the biased assimilation hypothesis, the effects of biological attributions depended on individual differences in RWA. Low-RWA participants showed higher levels of naturalness and discreteness/homogeneity beliefs about transgender identity in the biological determinist condition than those in the control condition. By contrast, high-RWA participants displayed higher levels of discreteness/homogeneity beliefs but similar levels of naturalness beliefs when they read the biological determinist message compared with the control group. Low-RWA participants showed higher levels of naturalness but similar levels of discreteness/homogeneity beliefs in the epigenetic condition compared with the control, whereas high-RWA participants exhibited lower levels of naturalness and higher levels of discreteness/homogeneity beliefs when they read the epigenetic message compared with the control group. This study also suggests that, contrary to attribution theory, presenting information regarding the biological basis of transgender identity does not necessarily lead to more positive attitudes because (a) it triggers essentialist thinking and (b) the effects of biological attributions depend on recipients' authoritarian dispositions.",2022,"Low-RWA participants showed higher levels of naturalness but similar levels of discreteness/homogeneity beliefs in the epigenetic condition compared with the control, whereas high-RWA participants exhibited lower levels of naturalness and higher levels of discreteness/homogeneity beliefs when they read the epigenetic message compared with the control group.","['183 Chinese university students (men: n\u2009=\u200985, women: n\u2009=\u200998) to read one of three fictitious articles']",['Biological Determinism'],['Beliefs and Attitudes'],"[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",183.0,0.0212771,"Low-RWA participants showed higher levels of naturalness but similar levels of discreteness/homogeneity beliefs in the epigenetic condition compared with the control, whereas high-RWA participants exhibited lower levels of naturalness and higher levels of discreteness/homogeneity beliefs when they read the epigenetic message compared with the control group.","[{'ForeName': 'Boby Ho-Hong', 'Initials': 'BH', 'LastName': 'Ching', 'Affiliation': 'Faculty of Education, University of Macau, Avenida da Universidade, Taipa, 999078, Macau. bhhching@um.edu.mo.'}, {'ForeName': 'Tiffany Ting', 'Initials': 'TT', 'LastName': 'Chen', 'Affiliation': 'Faculty of Education, University of Macau, Avenida da Universidade, Taipa, 999078, Macau.'}]",Archives of sexual behavior,['10.1007/s10508-021-02262-8']
863,35461158,"A randomized, crossover, phase I clinical study to evaluate bioequivalence and safety of tofacitinib and Xeljanz® in Chinese healthy subjects.","OBJECTIVE


Tofacitinib is an oral Janus kinase (JAK) inhibitor that has been marketed and approved in the USA for the clinical treatment of rheumatoid arthritis, psoriasis and other inflammatory and autoimmune diseases. A phase I clinical trial was conducted to compare the bioequivalence and safety of tofacitinib (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and Xeljanz® (Pfizer Inc.) in healthy Chinese subjects, providing basis for the clinical application of tofacitinib.
METHODS


Healthy Chinese subjects (N = 32) were randomly assigned to two groups at a 1:1 ratio. Subjects orally took 5 mg tofacitinib or Xeljanz® per cycle in random sequence. Blood samples were collected at 15 sampling points per cycle, and plasma drug concentrations of tofacitinib or Xeljanz® were analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and statistical analysis for the pharmacokinetic (PK) parameters. Subjects' physical indicators were monitored during the whole process to evaluate drug safety.
RESULTS


The adjusted geometric mean ratios (GMRs) of the peak concentration (C max ), area under the curve (AUC) from time zero to the last measurable concentration (AUC 0-t ) and AUC from time zero to observed infinity (AUC 0-∞ ) were all within the range of 80-125%. The other PK parameter values were similar. The above values were all meeting the bioequivalence criteria with well safety.
CONCLUSION


The pharmacokinetic parameters and safety profile of tofacitinib were similar to those of Xeljanz® in healthy Chinese subjects. Therefore, tofacitinib can be considered bioequivalent to Xeljanz®, and the findings of this trial will promote the clinical application of tofacitinib.",2022,The pharmacokinetic parameters and safety profile of tofacitinib were similar to those of Xeljanz® in healthy Chinese subjects.,"['Chinese healthy subjects', 'healthy Chinese subjects', 'Healthy Chinese subjects (N\xa0=\xa032']","['Xeljanz®', 'tofacitinib and Xeljanz®', 'tofacitinib (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and Xeljanz® (Pfizer Inc', 'tofacitinib or Xeljanz®']","['Blood samples', 'plasma drug concentrations of tofacitinib or Xeljanz®', 'adjusted geometric mean ratios (GMRs) of the peak concentration (C max ), area under the curve (AUC) from time zero to the last measurable concentration (AUC 0-t ) and AUC']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3505045', 'cui_str': 'Xeljanz'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C3256719', 'cui_str': 'Salvia hispanica seed extract'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C3505045', 'cui_str': 'Xeljanz'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0919414', 'cui_str': '0'}]",32.0,0.0952671,The pharmacokinetic parameters and safety profile of tofacitinib were similar to those of Xeljanz® in healthy Chinese subjects.,"[{'ForeName': 'Zhongnan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Clinical Research Center, Chia Tai Tianqing Pharmaceutical Group Co., Ltd, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Zhengzhi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Renjie', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Wuxi Apptec Co., Ltd, Shanghai, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Ansiterui Medical Technology Consulting Co., Ltd, Changchun, Jilin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lan', 'Affiliation': 'Wuxi Apptec Co., Ltd, Shanghai, China.'}, {'ForeName': 'Wenzhong', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Wuxi Apptec Co., Ltd, Shanghai, China.'}, {'ForeName': 'Guangwen', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Xinyao', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Zhengjie', 'Initials': 'Z', 'LastName': 'Su', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Wanhua', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Qiaohuan', 'Initials': 'Q', 'LastName': 'Deng', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Yicheng', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Puheng Technology Co., Ltd., Shanghai, China.'}, {'ForeName': 'Haimiao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Phase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China. Electronic address: haimiaoyang@outlook.com.'}]",International immunopharmacology,['10.1016/j.intimp.2022.108780']
864,35469468,"Letter to the editor concerning the article: ""Efficacy of whole-body vibration on balance control, postural stability, and mobility after thermal burn injuries: A prospective randomized controlled trial"".",,2022,,['after thermal burn injuries'],['whole-body vibration'],"['balance control, postural stability, and mobility']","[{'cui': 'C0701836', 'cui_str': 'Thermal burn'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0222598,,"[{'ForeName': 'Özden', 'Initials': 'Ö', 'LastName': 'Özkal', 'Affiliation': '37523Bursa Uludağ University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Bursa, Turkey.'}]",Clinical rehabilitation,['10.1177/02692155221088768']
865,35469462,"To the editor on ""The effectiveness of Kinesio Taping ®  for mobility and functioning improvement in knee osteoarthritis: A randomized, double-blind, controlled trial.""",,2022,,['knee osteoarthritis'],['Kinesio Taping ®'],[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}]",[],,0.862718,,"[{'ForeName': 'Kailimi', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'School of Kinesiology, 540176Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Kinesiology, 540176Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Luning', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'School of Kinesiology, 540176Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Hao-Yu', 'Initials': 'HY', 'LastName': 'Hu', 'Affiliation': 'School of Kinesiology, 540176Shanghai University of Sport, Shanghai, China.'}]",Clinical rehabilitation,['10.1177/02692155221091102']
866,35469778,The EEG correlates and dangerous behavioral consequences of drowsy driving after a single night of mild sleep deprivation.,"OBJECTIVE


Here, we investigated the behavioral, cognitive, and electrophysiological impact of mild, acute sleep loss via simultaneously recorded behavioral and electrophysiological measures of vigilance during a ""real-world"", simulated driving task.
METHODS


Participants (N = 34) visited the lab for two testing days where their brain activity and vigilance were simultaneously recorded during a driving simulator task. The driving task lasted approximately 70 mins and consisted of tailgating the lead car at high speed, which braked randomly, requiring participants to react quickly to avoid crashing. The night before testing, participants either slept from 12am-9am (Normally Rested), or 1am-6am (Sleep Restriction).
RESULTS


After a single night of mild sleep restriction, sleepiness was increased, participants took longer to brake, missed more braking events, and crashed more often. Brain activity showed more intense alpha burst activity and significant changes in EEG spectral power frequencies related to arousal (e.g., delta, theta, alpha). Importantly, increases in amplitude and number of alpha bursts predicted delays in reaction time when braking.
CONCLUSIONS


The findings of this study suggest that a single night of mild sleep loss has significant, negative consequences on driving performance and vigilance, and a clear impact on the physiology of the brain in ways that reflect reduced arousal.
SIGNIFICANCE


Understanding neural and cognitive changes associated with sleep loss may lead to important advancements in identifying and preventing potentially dangerous sleep-related lapses in vigilance.",2022,"Brain activity showed more intense alpha burst activity and significant changes in EEG spectral power frequencies related to arousal (e.g., delta, theta, alpha).",['Participants (N=34) visited the lab for two testing days where their'],[],"['brain activity and vigilance', 'mild sleep restriction, sleepiness', 'behavioral, cognitive, and electrophysiological impact of mild, acute sleep loss']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}]",,0.0518538,"Brain activity showed more intense alpha burst activity and significant changes in EEG spectral power frequencies related to arousal (e.g., delta, theta, alpha).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gibbings', 'Affiliation': ""Sleep Research Unit, The University of Ottawa's Institute of Mental Health Research at The Royal, Ottawa, K1Z 7K4, Canada; School of Psychology, University of Ottawa, Ottawa, K1N 6N5, Canada.""}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Ray', 'Affiliation': ""Sleep Research Unit, The University of Ottawa's Institute of Mental Health Research at The Royal, Ottawa, K1Z 7K4, Canada.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gagnon', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Collin', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Robillard', 'Affiliation': ""Sleep Research Unit, The University of Ottawa's Institute of Mental Health Research at The Royal, Ottawa, K1Z 7K4, Canada; School of Psychology, University of Ottawa, Ottawa, K1N 6N5, Canada.""}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Fogel', 'Affiliation': ""Sleep Research Unit, The University of Ottawa's Institute of Mental Health Research at The Royal, Ottawa, K1Z 7K4, Canada; School of Psychology, University of Ottawa, Ottawa, K1N 6N5, Canada; University of Ottawa Brain & Mind Research Institute, Ottawa, K1H 8M5, Canada. Electronic address: sfogel@uottawa.ca.""}]",Physiology & behavior,['10.1016/j.physbeh.2022.113822']
867,35471812,Randomised clinical trial: comparison of efficacy and adverse effects of a standard triple clarithromycin-containing regimen with high-dose amoxicillin and bismuth therapy in Helicobacter pylori eradication.,"BACKGROUND


The clarithromycin-based triple therapy is the most prescribed Helicobacter pylori eradication regimen in Europe; it causes adverse effects in a significant proportion of subjects, leading to discontinuation. Alternative therapies are required because of increasing clarithromycin resistance or to decrease the adverse effects.
AIMS


We compared the efficacy and spectrum of adverse effects of clarithromycin-based triple therapy with the high-dose amoxicillin/bismuth regimen.
METHODS


A randomised clinical trial enrolled healthy individuals aged 40-64 years. H. pylori was assessed with a 13C-urea breath test. In total 579 H. pylori-positive subjects were randomly allocated in two groups: group 1: clarithromycin 500 mg, amoxicillin 1000 mg, esomeprazole 40 mg, all twice daily; group 2: bismuth subcitrate 240 mg twice daily, amoxicillin 1000 mg three times daily, esomeprazole 40 mg twice daily. Regimens were administered for 14 days.Information on treatment completion and adverse effects were collected via a telephone interview at 21-28 days after medication delivery. The efficacy was assessed by UBT 6 months after the treatment.
RESULTS


We analysed 483 subjects for adverse effects (248 vs. 235 respectively). Furthermore, 316 subjects were analysed for efficacy. In per-protocol analysis, a higher efficacy was seen in group 1 (88.4 vs. 77.0%; P < 0.001); no difference was observed in compliance (90.3 and 91.2%). Therapy-related adverse effects were more common in group 1 (56.9 vs. 40.0%; P < 0.01). In intention-to-treat analysis no statistical difference in efficacy was revealed.
CONCLUSIONS


Bismuth-based high-dose amoxicillin therapy showed a lower efficacy but was less frequently associated with adverse effects. Further research is required to examine the high-dose amoxicillin and bismuth-containing regimens in various populations to maximise eradication efficacy.",2022,Therapy-related adverse effects were more common in group 1 (56.9 vs. 40.0%; P < 0.01).,"['healthy individuals aged 40-64 years', 'In total 579 H. pylori-positive subjects', '316 subjects', '483 subjects for adverse effects (248 vs. 235 respectively']","['clarithromycin 500 mg, amoxicillin 1000 mg, esomeprazole', 'amoxicillin therapy', 'clarithromycin-based triple therapy', 'amoxicillin/bismuth regimen', 'amoxicillin', 'standard triple clarithromycin-containing regimen with high-dose amoxicillin and bismuth therapy', 'bismuth subcitrate 240 mg twice daily, amoxicillin 1000 mg three times daily, esomeprazole']","['efficacy and adverse effects', 'adverse effects', 'Helicobacter pylori eradication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]","[{'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C1126881', 'cui_str': 'Amoxicillin 1000 MG'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0106556', 'cui_str': 'bismuth subcitrate'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",316.0,0.0759746,Therapy-related adverse effects were more common in group 1 (56.9 vs. 40.0%; P < 0.01).,"[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sjomina', 'Affiliation': 'Institute of Clinical and Preventive Medicine.'}, {'ForeName': 'Alise', 'Initials': 'A', 'LastName': 'Lielause', 'Affiliation': 'Institute of Clinical and Preventive Medicine.'}, {'ForeName': 'Aiga', 'Initials': 'A', 'LastName': 'Rūdule', 'Affiliation': 'Institute of Clinical and Preventive Medicine.'}, {'ForeName': 'Reinis', 'Initials': 'R', 'LastName': 'Vangravs', 'Affiliation': 'Institute of Clinical and Preventive Medicine.'}, {'ForeName': 'Sergejs', 'Initials': 'S', 'LastName': 'Paršutins', 'Affiliation': 'Institute of Clinical and Preventive Medicine.'}, {'ForeName': 'Inese', 'Initials': 'I', 'LastName': 'Poļaka', 'Affiliation': 'Institute of Clinical and Preventive Medicine.'}, {'ForeName': 'Ilva', 'Initials': 'I', 'LastName': 'Daugule', 'Affiliation': 'Institute of Clinical and Preventive Medicine.'}, {'ForeName': 'Ilmārs', 'Initials': 'I', 'LastName': 'Stonāns', 'Affiliation': 'Institute of Clinical and Preventive Medicine.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Mārcis', 'Initials': 'M', 'LastName': 'Leja', 'Affiliation': 'Institute of Clinical and Preventive Medicine.'}]",European journal of cancer prevention : the official journal of the European Cancer Prevention Organisation (ECP),['10.1097/CEJ.0000000000000718']
868,35473436,Impact of time-of-day and chronotype on neuromuscular performance in semi-professional female volleyball players.,"This study aimed to determine if time-of-day could influence physical volleyball performance in females and to explore the relationship between chronotype and volleyball-specific performance. Fifteen young female athletes participated in a randomized counterbalanced trial, performing a neuromuscular test battery in the morning (9:00 h) and the evening (19:00 h) that consisted of volleyball standing spike, straight leg raise, dynamic balance, vertical jump, modified agility T-test and isometric handgrip tests. Chronotype was determined by the morningness-eveningness questionnaire. Compared to the morning, an increased performance was found in the standing spike (4.5%, p = .002, ES = 0.59), straight leg raise test (dominant-limb) (6.5%, p = .012, ES = 0.40), dynamic balance (non-dominant-limb) (5.0%, p = .010, ES = 0.57) and modified T-test (2.1%, p = .049, ES = 0.45) performance in the evening; while no statistical differences were reported in vertical jump tests or isometric handgrip strength. Moreover, no associations were found between chronotype and neuromuscular performance (r = -0.368-0.435, p = .052-0.439). Time-of-day affected spike ball velocity, flexibility in the dominant-limb, dynamic balance in the non-dominant-limb and agility tests. However, no association was reported among these improvements and the chronotype. Therefore, although the chronotype may not play critical role in volleyball-specific performance, evening training/matches schedules could benefit performance in semi-professional female volleyball players.",2022,"Compared to the morning, an increased performance was found in the standing spike (4.5%, p = .002, ES = 0.59), straight leg raise test (dominant-limb) (6.5%, p = .012, ES = 0.40), dynamic balance (non-dominant-limb) (5.0%, p = .010, ES = 0.57) and modified T-test (2.1%, p = .049, ES = 0.45) performance in the evening; while no statistical differences were reported in vertical jump tests or isometric handgrip strength.","['Fifteen young female athletes', 'semi-professional female volleyball players']","['time-of-day and chronotype', 'neuromuscular test battery in the morning (9:00 h) and the evening (19:00 h) that consisted of volleyball standing spike, straight leg raise, dynamic balance, vertical jump, modified agility T-test and isometric handgrip tests']","['standing spike', 'physical volleyball performance', 'chronotype and neuromuscular performance', 'spike ball velocity, flexibility in the dominant-limb, dynamic balance', 'neuromuscular performance', 'vertical jump tests or isometric handgrip strength', 'straight leg raise test', 'dynamic balance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0439548', 'cui_str': 'Temporal periods of day'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4720934', 'cui_str': 'Vertical jump test'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C1288281', 'cui_str': 'Lasègue test'}]",15.0,0.0293599,"Compared to the morning, an increased performance was found in the standing spike (4.5%, p = .002, ES = 0.59), straight leg raise test (dominant-limb) (6.5%, p = .012, ES = 0.40), dynamic balance (non-dominant-limb) (5.0%, p = .010, ES = 0.57) and modified T-test (2.1%, p = .049, ES = 0.45) performance in the evening; while no statistical differences were reported in vertical jump tests or isometric handgrip strength.","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Martín-López', 'Affiliation': 'Exercise Physiology Group, School of Sports Sciences, Faculty of Health Sciences, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Sedliak', 'Affiliation': 'Department of Biological and Medical Sciences, Faculty of Physical Education and Sport, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Valadés', 'Affiliation': 'Departamento de Ciencias Biomédicas, Área de Educación Física y Deportiva, Facultad de Medicina y Ciencias de la Salud, Universidad de Alcalá, Madrid, España.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Group, School of Sports Sciences, Faculty of Health Sciences, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Buffet-García', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'García-Oviedo', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Aragón', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pérez-López', 'Affiliation': 'Departamento de Ciencias Biomédicas, Área de Educación Física y Deportiva, Facultad de Medicina y Ciencias de la Salud, Universidad de Alcalá, Madrid, España.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'López-Samanes', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, Madrid, Spain.'}]",Chronobiology international,['10.1080/07420528.2022.2057322']
869,35475852,Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Treatment of actinic keratosis (AK) aims to prevent cutaneous squamous cell carcinoma (cSCC). However, whether AK can progress into invasive cSCC is a matter of debate, and little is known about the effect of treatment on preventing cSCC.
Objectives


To evaluate the risk of invasive cSCC and factors that may contribute to increased risk in patients with multiple AKs.
Design, Setting, and Participants


In this secondary analysis of a multicenter randomized clinical trial, 624 patients with a minimum of 5 AKs within an area of 25 to 100 cm2 on the head were recruited from the Department of Dermatology of 4 hospitals in the Netherlands. Long-term follow-up was performed from July 1, 2019, to December 31, 2020.
Interventions


Patients were randomized to treatment with 5% fluorouracil, 5% imiquimod cream, methylaminolevulinate photodynamic therapy, or 0.015% ingenol mebutate gel.
Main Outcomes and Measures


The primary outcome was the proportion of patients with invasive cSCC in the target area during follow-up. Secondary outcomes were the associations between risk of invasive cSCC and a priori defined potential prognostic factors, including type of treatment, severity of AK (Olsen grade), history of nonmelanoma skin cancer, and additional treatment.
Results


Of the 624 patients (558 [89.4%] male; median age, 73 years [range, 48-94 years]) in the study, 26 were diagnosed with a histologically proven invasive cSCC in the target area during follow-up. The total 4-year risk of developing cSCC in a previously treated area of AK was 3.7% (95% CI, 2.4%-5.7%), varying from 2.2% (95% CI, 0.7%-6.6%) in patients treated with fluorouracil to 5.8% (95% CI, 2.9%-11.3%) in patients treated with imiquimod. In patients with severe AK (Olsen grade III), the risk was 20.9% (95% CI, 10.8%-38.1%), and the risk was especially high (33.5%; 95% CI, 18.2%-56.3%) in patients with severe AK who needed additional treatment.
Conclusions and Relevance


In this secondary analysis of a randomized clinical trial, risk of invasive cSCC was highest in patients with Olsen grade III AK and was substantially increased in patients who received additional treatment. These patients should be closely followed up after treatment.
Trial Registration


ClinicalTrials.gov Identifier: NCT02281682.",2022,"In patients with severe AK (Olsen grade III), the risk was 20.9% (95% CI, 10.8%-38.1%), and the risk was especially high (33.5%; 95% CI, 18.2%-56.3%) in patients with severe AK who needed additional treatment.
","['cutaneous squamous cell carcinoma (cSCC', 'Invasive Cutaneous Squamous Cell Carcinoma', 'patients with multiple AKs', 'actinic keratosis (AK', '624 patients with a minimum of 5 AKs within an area of 25 to 100 cm2 on the head were recruited from the Department of Dermatology of 4 hospitals in the Netherlands', 'Actinic Keratosis', '624 patients (558 [89.4%] male; median age, 73 years [range, 48-94 years]) in the study, 26 were diagnosed with a histologically proven invasive cSCC in the target area during follow-up']","['fluorouracil', '5% fluorouracil, 5% imiquimod cream, methylaminolevulinate photodynamic therapy, or 0.015% ingenol mebutate gel', 'imiquimod']","['risk of invasive cSCC and a priori defined potential prognostic factors, including type of treatment, severity of AK (Olsen grade), history of nonmelanoma skin cancer, and additional treatment', 'total 4-year risk of developing cSCC', 'proportion of patients with invasive cSCC']","[{'cui': 'C0553723', 'cui_str': 'Squamous cell carcinoma of skin'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C4517396', 'cui_str': '0.015'}, {'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0553723', 'cui_str': 'Squamous cell carcinoma of skin'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",624.0,0.260665,"In patients with severe AK (Olsen grade III), the risk was 20.9% (95% CI, 10.8%-38.1%), and the risk was especially high (33.5%; 95% CI, 18.2%-56.3%) in patients with severe AK who needed additional treatment.
","[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Ahmady', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Maud H E', 'Initials': 'MHE', 'LastName': 'Jansen', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Patty J', 'Initials': 'PJ', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Janneke P H M', 'Initials': 'JPHM', 'LastName': 'Kessels', 'Affiliation': 'Department of Dermatology, Zuyderland Medical Center, Heerlen, the Netherlands.'}, {'ForeName': 'Aimee H M M', 'Initials': 'AHMM', 'LastName': 'Arits', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Michette J M', 'Initials': 'MJM', 'LastName': 'de Rooij', 'Affiliation': 'Department of Dermatology, VieCuri Medical Center, Venlo, the Netherlands.'}, {'ForeName': 'Brigitte A B', 'Initials': 'BAB', 'LastName': 'Essers', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Patricia J F', 'Initials': 'PJF', 'LastName': 'Quaedvlieg', 'Affiliation': 'Department of Dermatology, Zuyderland Medical Center, Heerlen, the Netherlands.'}, {'ForeName': 'Nicole W J', 'Initials': 'NWJ', 'LastName': 'Kelleners-Smeets', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Mosterd', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, the Netherlands.'}]",JAMA dermatology,['10.1001/jamadermatol.2022.1034']
870,35477380,HIP Fracture REhabilitation Program for older adults with hip fracture (HIP-REP) based on activity of daily living: a feasibility study.,"BACKGROUND


A Rehabilitation Program for older adults with hip fracture (HIP-REP) based on Activity of Daily Living has been developed. The objectives of this study were to assess the feasibility and safety of the HIP-REP program to inform a future randomized controlled trial (RCT).
METHODS


A feasibility study Inspired by the Complex-intervention development (Medical Research Council framework phase II) design using quantitative and qualitative research methods were conducted. Eighteen participants (above 65 years) with hip fracture were recruited from the orthopedic wards. The setting was cross sectoral including Copenhagen University Hospital, Herlev and Gentofte and rehabilitation centers in Herlev, Gentofte and Lyngby-Taarbæk municipalities. A cross-sectoral rehabilitation intervention tailored to the needs of older adults with hip fracture highlighting systematic goal setting and strategies focused on activities of daily living was conducted. Pre-defined feasibility criteria: participants recruitment and retention, duration of measuring the outcome, adherence to intervention, and adverse events, along with self-reported outcomes and an objective measurement of performance in activity of daily living. Focus groups were analyzed using a deductive manifest content analysis approach. Descriptive statistical analysis and paired t-tests were performed for assessing change in outcome measures.
RESULTS


Recruitment rate was 4.5/month. Outcome measures were performed but length and number of questionnaires were a burden. Thirteen out of eighteen participants completed the study three dropped out and two died. Adherence among the 13 was 100%. Focus group revealed issues regarding coordinating the intervention, ensuring procedural processes across sectors regarding recruitment of participants, and documentation in the database. Participants expressed satisfaction with the intervention and felt safe during intervention. Assessment of Motor and Process Skills showed better increase between (range 0.4 to 1.6) in ADL motor ability measures and better increase between (range 0.4 to 0.7) for process ability. No clear association between outcome improvements and intervention adherence.
CONCLUSIONS


The cross-sectoral intervention based on daily activities was feasible and safe for older adults with hip fracture. A future RCT, with an improved recruitment strategy and reduced number of outcome measures will evaluate the effectiveness in improving independence and safety performance of activity of daily living.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03828240 . Registered on January 29, 2019.",2022,Assessment of Motor and Process Skills showed better increase between (range 0.4 to 1.6) in ADL motor ability measures and better increase between (range 0.4 to 0.7) for process ability.,"['Eighteen participants (above 65\xa0years) with hip fracture were recruited from the orthopedic wards', 'older adults with hip fracture', 'older adults with hip fracture (HIP-REP', 'Thirteen out of eighteen participants completed the study three dropped out and two died']","['HIP-REP program', 'HIP Fracture REhabilitation Program', 'Complex-intervention development']","['feasibility and safety', 'length and number of questionnaires', 'objective measurement of performance in activity of daily living']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",18.0,0.0809859,Assessment of Motor and Process Skills showed better increase between (range 0.4 to 1.6) in ADL motor ability measures and better increase between (range 0.4 to 0.7) for process ability.,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Røpke', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte, Copenhagen, Denmark. aliceropke@me.com.'}, {'ForeName': 'Anne-Le', 'Initials': 'AL', 'LastName': 'Morville', 'Affiliation': 'ADULT Research Group, Department of Rehabilitation, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Trine Elleby', 'Initials': 'TE', 'LastName': 'Møller', 'Affiliation': ""Municipality of Gentofte, Municipality of Gentofte's Centre for Prevention and Rehabilitation, Copenhagen, Denmark.""}, {'ForeName': 'Emma Cæcilie Guttzeit', 'Initials': 'ECG', 'LastName': 'Delkus', 'Affiliation': 'Center for Training and Rehabilitation, Municipality of Lyngby-Taarbaek, Lyngby-Taarbaek, Denmark.'}, {'ForeName': 'Carsten Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte, Copenhagen, Denmark.'}]",BMC geriatrics,['10.1186/s12877-022-03039-x']
871,35482329,Association between cardiorespiratory fitness and cerebrovascular reactivity to a breath-hold stimulus in older adults: influence of aerobic exercise training.,"Cerebrovascular reactivity (CVR) to a physiological stimulus is a commonly used surrogate of cerebrovascular health. Cross-sectional studies using blood oxygen level dependent (BOLD) neuroimaging demonstrated lower BOLD-CVR to hypercapnia among adults with high compared with lower cardiorespiratory fitness (CRF) in contrast to transcranial Doppler studies. However, whether BOLD-CVR changes following chronic aerobic exercise in older, cognitively intact adults is unclear. This study evaluated relations between BOLD-CVR with CRF (V̇o 2peak ) using a cross-sectional and interventional study design. We hypothesized that  1 ) greater CRF would be associated with lower BOLD-CVR in older adults ( n  = 114; 65 ± 6.5 yr) with a wide range of CRF and  2 ) BOLD-CVR would be attenuated after exercise training in a subset ( n  = 33) randomized to 3-mo of moderate- or light-intensity cycling. CVR was quantified as the change in the BOLD signal in response to acute hypercapnia using a blocked breath-hold design from a region-of-interest analysis for cortical networks. In the cross-sectional analysis, there was a quadratic relation between V̇o 2peak  ( P  = 0.03), but not linear ( P  = 0.87) and cortical BOLD-CVR. BOLD-CVR increased until a V̇o 2peak  ∼28 mL/kg/min after which BOLD-CVR declined. The nonlinear trend was consistent across all networks ( P  = 0.04-0.07). In the intervention, both the active and light-intensity exercise groups improved CRF similarly (6% vs. 10.8%,  P  = 0.28). The percent change in CRF was positively associated with change in BOLD-CVR in the default mode network only. These data suggest that BOLD-CVR is nonlinearly associated with CRF and that in lower-fit adults default mode network may be most sensitive to CRF-related increases in BOLD-CVR. NEW & NOTEWORTHY  Earlier studies evaluating associations between cardiorespiratory fitness (CRF) and cerebrovascular reactivity (CVR) have demonstrated conflicting findings dependent on imaging modality or subject characteristics in individuals across a narrow range of CRF. This study demonstrates that CRF is nonlinearly associated with CVR measured by blood oxygen level dependent (BOLD) fMRI in a large sample of middle-aged and older adults across a wide range of CRF, suggesting that conflicting prior findings are related to the range of CRFs studied.",2022,"In the cross-sectional analysis, there was a quadratic relation between VO 2peak  (p=0.03), but not linear (p=0.87), and cortical BOLD-CVR.","['adults with high compared with lower cardiorespiratory fitness (CRF', 'Older Adults', 'older adults (n=114; 65±6.5 years) with a wide range of CRF']","['Aerobic Exercise Training', 'BOLD-CVR with CRF (VO 2peak ', 'chronic aerobic exercise', 'Blood Oxygen Level Dependent (BOLD']","['BOLD-CVR increased until a VO 2peak', 'BOLD-CVR', 'Cerebrovascular reactivity (CVR', 'CRF', 'CVR', 'cortical BOLD-CVR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}]",,0.0386789,"In the cross-sectional analysis, there was a quadratic relation between VO 2peak  (p=0.03), but not linear (p=0.87), and cortical BOLD-CVR.","[{'ForeName': 'Lyndsey E', 'Initials': 'LE', 'LastName': 'DuBose', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Weng', 'Affiliation': 'Department Psychological and Brain Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pierce', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Conner', 'Initials': 'C', 'LastName': 'Wharff', 'Affiliation': 'Department Psychological and Brain Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Reist', 'Affiliation': 'Department Psychological and Brain Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Chase', 'Initials': 'C', 'LastName': 'Hamilton', 'Affiliation': 'Department Psychological and Brain Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': ""O'Deen"", 'Affiliation': 'Department Psychological and Brain Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Dubishar', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Abbi', 'Initials': 'A', 'LastName': 'Lane-Cordova', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Voss', 'Affiliation': 'Department Psychological and Brain Sciences, University of Iowa, Iowa City, Iowa.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00599.2021']
872,35482652,LGBQ-affirmative cognitive-behavioral therapy for young gay and bisexual men's mental and sexual health: A three-arm randomized controlled trial.,"OBJECTIVE


Effective Skills to Empower Effective Men (ESTEEM) represents the first intervention to address the psychological pathways through which minority stress undermines young sexual minority men's (SMM's) mental and sexual health using transdiagnostic cognitive-behavioral therapy. This study compared the efficacy of ESTEEM against two existing interventions.
METHOD


Participants were young HIV-negative SMM ( N  = 254; ages = 18-35; 67.2% racial/ethnic minority) experiencing a depression, anxiety, and/or stress-/trauma-related disorder and past-90-day HIV transmission risk behavior. After completing HIV testing and counseling, participants were randomized to receive 10-session ESTEEM ( n  = 100); 10-session community-based LGBQ-affirmative counseling ( n  = 102); or only HIV testing and counseling ( n  = 52).
RESULTS


For the primary outcome of any HIV transmission risk behavior at 8 months, ESTEEM was not significantly associated with greater reduction compared to HIV testing and counseling (risk ratio [RR] = 0.89,  p  = .52). Supportive analyses of the  frequency  of HIV transmission risk behavior at 8 months showed a nonsignificant difference between ESTEEM compared to HIV testing and counseling (RR = 0.69) and LGBQ-affirmative counseling (RR = 0.62). For secondary outcomes (e.g., depression, anxiety, substance use, suicidality, number of mental health diagnoses) at 8 months, ESTEEM had a larger effect size than the two comparison conditions, but these comparisons did not reach statistical significance when adjusting for the false discovery rate. Observed effect sizes for condition comparisons were smaller than the effect sizes used to power the study. In exploratory analyses, ESTEEM showed promise for reducing comorbidity.
CONCLUSIONS


Because the control conditions were associated with stronger effects than anticipated, and given the heterogeneous nature of transdiagnostic outcomes, the study possessed insufficient power to statistically detect the consistently small-to-moderate benefit of ESTEEM compared to the two control conditions. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"For the primary outcome of any HIV transmission risk behavior at 8 months, ESTEEM was not significantly associated with greater reduction compared to HIV testing and counseling (risk ratio [RR] = 0.89,  p  = .52).","[""young gay and bisexual men's mental and sexual health"", 'Participants were young human immunodeficiency virus (HIV)-negative SMM ( N  = 254; ages = 18-35; 67.2% racial/ethnic minority) experiencing a depression, anxiety, and/or stress-/trauma-related disorder and past-90-day HIV transmission risk behavior', ""minority stress undermines young sexual minority men's (SMM's) mental and sexual health using transdiagnostic cognitive-behavioral therapy""]","['10-session ESTEEM ( n  = 100); 10-session community-based lesbian, gay, bisexual, and queer/questioning (LGBQ)-affirmative counseling ( n  = 102); or only HIV testing and counseling ( n  = 52', 'LGBQ-affirmative cognitive-behavioral therapy']","['HIV transmission risk behavior', 'depression, anxiety, substance use, suicidality, number of mental health diagnoses']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1531608', 'cui_str': 'Smoldering myeloma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1096045', 'cui_str': 'Human immunodeficiency virus transmission'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1822301', 'cui_str': 'Wound tissue undermining'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242659', 'cui_str': 'Female homosexual'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1096045', 'cui_str': 'Human immunodeficiency virus transmission'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.0710563,"For the primary outcome of any HIV transmission risk behavior at 8 months, ESTEEM was not significantly associated with greater reduction compared to HIV testing and counseling (risk ratio [RR] = 0.89,  p  = .52).","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pachankis', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Harkness', 'Affiliation': 'Department of Public Health Sciences.'}, {'ForeName': 'Kaitlin R', 'Initials': 'KR', 'LastName': 'Maciejewski', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Behari', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kirsty A', 'Initials': 'KA', 'LastName': 'Clark', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McConocha', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Winston', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Oluwaseyi', 'Initials': 'O', 'LastName': 'Adeyinka', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bränström', 'Affiliation': 'Department of Clinical Neuroscience.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Esserman', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hatzenbuehler', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'Department of Psychology.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000724']
873,35487344,"Letter to Editor on ""A randomized, controlled, blinded, parallel-group, clinical trial to study the role of Ayurcov (AyurCoro3), a one-day regimen as an adjuvant therapy for COVID-19 disease management, at dedicated Covid Hospital (DCH) in India"".",,2022,,[],['Ayurcov '],[],[],[],[],,0.291012,,"[{'ForeName': 'Bharat Krushna', 'Initials': 'BK', 'LastName': 'Khuntia', 'Affiliation': 'Centre for Integrative Medicine and Research (CIMR), All India Institute of Medical Sciences, New Delhi, India. Electronic address: aurobharat@gmail.com.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Centre for Integrative Medicine and Research (CIMR), All India Institute of Medical Sciences, New Delhi, India. Electronic address: amanstatistician01@gmail.com.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Centre for Integrative Medicine and Research (CIMR), All India Institute of Medical Sciences, New Delhi, India. Electronic address: drgautamsharma12@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2022.102838']
874,35460165,"The pharmacokinetics of oral trazpiroben (TAK-906) after organic anion transporting polypeptide 1B1/1B3 inhibition: A phase I, randomized study.","Trazpiroben is a dopamine D 2  /D 3  receptor antagonist under development for the treatment of gastroparesis. This phase I, open-label, randomized, two-way crossover study (NCT04121078) evaluated the effect of single-dose intravenous rifampin, a potent inhibitor of the organic anion transporting polypeptides (OATPs) 1B1 and 1B3, on the pharmacokinetics and safety of trazpiroben in healthy adults. The utility of coproporphyrin (CP) I and CPIII as biomarkers of OATP inhibition was also assessed. Overall, 12 participants were enrolled and randomized (1:1) into one of two treatment sequences (AB and BA). Participants received either a single oral dose of trazpiroben 25 mg (treatment A) or a single oral dose of trazpiroben 25 mg immediately after a single 30-min intravenous infusion of rifampin 600 mg (treatment B). After a washout period of at least 7 days, participants received the other treatment. Geometric mean area under the curve from time 0 extrapolated to infinity (AUC ∞  ) and maximum serum concentration (C max  ) of plasma trazpiroben were higher in participants receiving treatment B than those receiving treatment A (AUC ∞  , 168.5 vs. 32.68 ng*h/ml; C max  , 89.62 vs. 14.37 ng/ml); corresponding geometric mean ratios (90% confidence interval) showed 5.16 (4.25-6.25) and 6.24 (4.62-8.42)-fold increases in these parameters, respectively. In this study, trazpiroben was confirmed as a substrate of OATP1B1/1B3, and therefore co-administration of trazpiroben with moderate to strong inhibitors of OATP1B1/1B3 is not recommended. This is also the first assessment of the utility of CPI and CPIII as endogenous biomarkers of OATP1B1/1B3 inhibition after a single intravenous dose of rifampin.",2022,This is also the first assessment of the utility of CPI and CPIII as endogenous biomarkers of OATP1B1/1B3 inhibition after a single intravenous dose of rifampin.,"['After Organic Anion Transporting Polypeptide 1B1/1B3 Inhibition', '12 participants', 'healthy adults']","['Oral Trazpiroben (TAK-906', 'trazpiroben', 'rifampin', 'coproporphyrins (CP', 'Trazpiroben']","['OATP inhibition', 'Geometric mean area under the curve from time 0 extrapolated to infinity (AUC ∞  ) and maximum serum concentration (C max  ) of plasma trazpiroben', 'geometric mean ratios']","[{'cui': 'C0003075', 'cui_str': 'Anions'}, {'cui': 'C1305923', 'cui_str': 'Polypeptide'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0009988', 'cui_str': 'Coproporphyrin'}]","[{'cui': 'C0949791', 'cui_str': 'OATP Proteins'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",12.0,0.0815616,This is also the first assessment of the utility of CPI and CPIII as endogenous biomarkers of OATP1B1/1B3 inhibition after a single intravenous dose of rifampin.,"[{'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Mukker', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dukes', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Tolkoff', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Lisi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Almansa', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Susanna Y', 'Initials': 'SY', 'LastName': 'Huh', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Nishihara', 'Affiliation': 'Takeda Pharmaceutical Company, Limited, Fujisawa, Japan.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Ramsden', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}]",Clinical and translational science,['10.1111/cts.13274']
875,35460359,Effect of nitrate supplementation on skeletal muscle motor unit activity during isometric blood flow restriction exercise.,"BACKGROUND


Nitrate (NO 3 - ) supplementation has been reported to lower motor unit (MU) firing rate (MUFR) during dynamic resistance exercise; however, its impact on MU activity during isometric and ischemic exercise is unknown.
PURPOSE


To assess the effect of NO 3 -  supplementation on knee extensor MU activities during brief isometric contractions and a 3 min sustained contraction with blood flow restriction (BFR).
METHODS


Sixteen healthy active young adults (six females) completed two trials in a randomized, double-blind, crossover design. Trials were preceded by 5 days of either NO 3 -  (NIT) or placebo (PLA) supplementation. Intramuscular electromyography was used to determine the M. vastus lateralis MU potential (MUP) size, MUFR and near fibre (NF) jiggle (a measure of neuromuscular stability) during brief (20 s) isometric contractions at 25% maximal strength and throughout a 3 min sustained BFR isometric contraction.
RESULTS


Plasma nitrite (NO 2 - ) concentration was elevated after NIT compared to PLA (475 ± 93 vs. 198 ± 46 nmol L -1 , p < 0.001). While changes in MUP area, NF jiggle and MUFR were similar between NIT and PLA trials (all p > 0.05), MUP duration was shorter with NIT compared to PLA during brief isometric contractions and the sustained ischemic contraction (p < 0.01). In addition, mean MUP duration, MUP area and NF jiggle increased, and MUFR decreased over the 3 min sustained BFR isometric contraction for both conditions (all p < 0.05).
CONCLUSIONS


These findings provide insight into the effect of NO 3 -  supplementation on MUP properties and reveal faster MUP duration after short-term NO 3 -  supplementation which may have positive implications for skeletal muscle contractile performance.",2022,"Plasma nitrite (NO 2 - ) concentration was elevated after NIT compared to PLA (475 ± 93 vs. 198 ± 46 nmol L -1 , p < 0.001).",['Sixteen healthy active young adults (six females'],"['placebo (PLA) supplementation', 'nitrate supplementation', 'Intramuscular electromyography', 'Nitrate (NO 3 - ) supplementation']","['sustained ischemic contraction', 'knee extensor MU activities', 'mean MUP duration, MUP area and NF jiggle increased, and MUFR', 'Plasma nitrite (NO 2 - ) concentration', 'BFR isometric contraction', 'M. vastus lateralis MU potential (MUP) size, MUFR and near fibre (NF) jiggle', 'MUP duration', 'MUP area, NF jiggle and MUFR']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0065548', 'cui_str': 'major urinary proteins'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",16.0,0.217983,"Plasma nitrite (NO 2 - ) concentration was elevated after NIT compared to PLA (475 ± 93 vs. 198 ± 46 nmol L -1 , p < 0.001).","[{'ForeName': 'Ozcan', 'Initials': 'O', 'LastName': 'Esen', 'Affiliation': 'Department of Health Professions, Manchester Metropolitan University, Manchester, M15 6GX, UK. Ozcan.esen@mmu.ac.uk.'}, {'ForeName': 'Azmy', 'Initials': 'A', 'LastName': 'Faisal', 'Affiliation': 'Department of Sport and Exercise Sciences, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Zambolin', 'Affiliation': 'Department of Sport and Exercise Sciences, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Callaghan', 'Affiliation': 'Department of Health Professions, Manchester Metropolitan University, Manchester, M15 6GX, UK.'}]",European journal of applied physiology,['10.1007/s00421-022-04946-y']
876,35462372,Desidustat in Anemia due to Non-Dialysis-Dependent Chronic Kidney Disease: A Phase 3 Study (DREAM-ND).,"BACKGROUND


Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is being developed to treat anemia in patients with chronic kidney disease (CKD) without dialysis dependency.
METHODS


In total, 588 patients with a clinical diagnosis of anemia due to CKD without dialysis need and with baseline hemoglobin of 7.0-10.0 g/dL (inclusive) were randomized in a 1:1 ratio to receive either desidustat 100 mg oral tablets thrice a week for 24 weeks or biosimilar darbepoetin subcutaneous injection 0.75 μg/kg once in 2 weeks for 24 weeks. The primary outcome was the change from baseline in hemoglobin to evaluation period of Weeks 16-24. Key secondary outcomes included the number of patients with hemoglobin response, changes in the hepcidin levels, changes in the vascular endothelial growth factor (VEGF) levels, and changes in the lipid and lipoprotein profiles.
RESULTS


Hemoglobin change from baseline to Weeks 16-24 was 1.95 g/dL in the desidustat group and 1.83 g/dL in the darbepoetin group (difference: 0.11 g/dL; 95% CI: -0.12, 0.34), which met prespecified non-inferiority margin (-0.75 g/dL). The hemoglobin responders were significantly higher (p = 0.0181) in the desidustat group (196 [77.78%]) compared to the darbepoetin group (176 [68.48%]). The difference of change in hepcidin from baseline to Week 12 and Week 24 (p = 0.0032 at Week 12, p = 0.0016 at Week 24) and the difference of change in low-density lipoprotein from baseline to Week 24 (p value = 0.0269) between the two groups was statistically significant. The difference of change from baseline in VEGF to Weeks 12 and 24 between the two groups was not statistically significant.
CONCLUSION


Desidustat is non-inferior to darbepoetin in the treatment of anemia due to non-dialysis dependent CKD and it is well-tolerated.",2022,"The difference of change in hepcidin from baseline to Week 12 and Week 24 (p = 0.0032 at Week 12, p = 0.0016 at Week 24) and the difference of change in low-density lipoprotein from baseline to Week 24 (p value = 0.0269) between the two groups was statistically significant.","['Desidustat in Anemia due to Non-Dialysis-Dependent Chronic Kidney Disease', 'patients with chronic kidney disease (CKD) without dialysis dependency', '588 patients with a clinical diagnosis of anemia due to CKD without dialysis need and with baseline hemoglobin of 7.0-10.0 g/dL']",[],"['hemoglobin responders', 'low-density lipoprotein', 'change in hepcidin', 'Hemoglobin change', 'number of patients with hemoglobin response, changes in the hepcidin levels, changes in the vascular endothelial growth factor (VEGF) levels, and changes in the lipid and lipoprotein profiles']","[{'cui': 'C5198569', 'cui_str': 'desidustat'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}]",588.0,0.176971,"The difference of change in hepcidin from baseline to Week 12 and Week 24 (p = 0.0032 at Week 12, p = 0.0016 at Week 24) and the difference of change in low-density lipoprotein from baseline to Week 24 (p value = 0.0269) between the two groups was statistically significant.","[{'ForeName': 'Dhananjai', 'Initials': 'D', 'LastName': 'Agrawal', 'Affiliation': 'Sawai Man Singh (SMS) Medical College and Hospital, Jaipur, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Varade', 'Affiliation': 'Asian Institute of Medical Sciences (AIMS) Hospital, Dombivli (E), India.'}, {'ForeName': 'Hardik', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Shree Ashirwad Hospital, Dombivali, India.'}, {'ForeName': 'Alm', 'Initials': 'A', 'LastName': 'Nazar', 'Affiliation': 'National Hospital of Sri Lanka, Colombo, Sri Lanka.'}, {'ForeName': 'Jayakumar', 'Initials': 'J', 'LastName': 'Krishnan', 'Affiliation': 'Department of Nephrology Super Speciality Block, Govt. Medical College, Kozhikode, India.'}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Shukla', 'Affiliation': 'KRM Hospital and Research Centre, Lucknow, India.'}, {'ForeName': 'Chinta', 'Initials': 'C', 'LastName': 'Ramakrishna', 'Affiliation': 'Vedanta Hospital, Guntur, India.'}, {'ForeName': 'Mahel Chinthana', 'Initials': 'MC', 'LastName': 'Bandara Galahitiyawa', 'Affiliation': 'Nephrology Dialysis and Transplant Unit, Sri Jayawardenepura General Hospital, Colombo, Sri Lanka.'}, {'ForeName': 'Sidhharth B', 'Initials': 'SB', 'LastName': 'Mavani', 'Affiliation': 'Thakershy Charitable Trust Hospital, Ahmedabad, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Rajanna', 'Affiliation': 'Kempegowda Institute of Medical Sciences (KIMS) Hospital and Research Centre, Bengaluru, India.'}, {'ForeName': 'Petkar', 'Initials': 'P', 'LastName': 'Jikki', 'Affiliation': 'Department of Nephrology, Kurnool Medical College and Government General Hospital, Kurnool, India.'}, {'ForeName': 'Shamila', 'Initials': 'S', 'LastName': 'De Silva', 'Affiliation': 'Colombo North Teaching Hospital, Ragama, Sri Lanka.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Ruhela', 'Affiliation': 'Shri Mahant Indiresh Hospital, Dehradun, India.'}, {'ForeName': 'Parshottam', 'Initials': 'P', 'LastName': 'Koradia', 'Affiliation': 'BAPS Pramukh Swami Hospital, Surat, India.'}, {'ForeName': 'Kevinkumar', 'Initials': 'K', 'LastName': 'Kansagra', 'Affiliation': 'Zydus Research Center, Ahmedabad, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Kanani', 'Affiliation': 'Zydus Research Center, Ahmedabad, India.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Zydus Research Center, Ahmedabad, India.'}, {'ForeName': 'Kuldipsinh', 'Initials': 'K', 'LastName': 'Zala', 'Affiliation': 'Zydus Research Center, Ahmedabad, India.'}, {'ForeName': 'Deven', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Clinical R & D, Zydus Therapeutics Inc., Pennington, New Jersey, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000523961']
877,35462369,Desidustat in Anemia due to Dialysis-Dependent Chronic Kidney Disease: A Phase 3 Study (DREAM-D).,"BACKGROUND


A phase 3 study to assess the efficacy and safety of the desidustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, against the epoetin alfa for the treatment of anemia in patients with chronic kidney disease (CKD) with dialysis dependency.
METHODS


DREAM-D was a phase 3, multicenter, open-label, randomized, active-controlled clinical study conducted across 38 centers in India. A total of 392 patients with clinical diagnosis of anemia due to CKD with dialysis need (Erythrocyte Stimulating Agent [ESA] naïve or prior ESA users) and with baseline hemoglobin levels of 8.0-11.0 g/dL (inclusive) were randomized in a 1:1 ratio to receive either desidustat oral tablets (thrice a week) or epoetin alfa subcutaneous injection for 24 weeks to maintain a hemoglobin level of 10-12 g/dL. The primary endpoint was to assess the change in the hemoglobin level between the desidustat and the epoetin alfa groups from the baseline to evaluation period week 16-24. The key secondary efficacy endpoint was the number of patients with hemoglobin response.
RESULTS


The least square mean (standard error) change in hemoglobin from the baseline to week 16-24 was 0.95 (0.09) g/dL in the desidustat group and 0.80 (0.09) g/dL in the epoetin alfa group (difference: 0.14 [0.14] g/dL; 95% confidence interval: -0.1304, 0.4202), which met the prespecified noninferiority margin. The number of hemoglobin responders was significantly higher in the desidustat group (106 [59.22%]) when compared to the epoetin alfa group (89 [48.37%]) (p = 0.0382). The safety profile of the desidustat oral tablet was comparable with the epoetin alfa injection. There were no new risks or no increased risks seen with the use of desidustat compared to epoetin alfa.
CONCLUSION


In this study, desidustat was found to be noninferior to epoetin in the treatment of anemia in CKD patients on dialysis and it was well-tolerated. Clinical Trial Registry Identifier: CTRI/2019/12/022312 (India).",2022,"There were no new risks or no increased risks seen with the use of desidustat compared to epoetin alfa.
","['392 patients with clinical diagnosis of anemia due to CKD with dialysis need (Erythrocyte Stimulating Agent [ESA] naïve or prior ESA users) and with baseline hemoglobin levels of 8.0-11.0 g/dL (inclusive', '38 centers in India', 'patients with chronic kidney disease (CKD) with dialysis dependency', 'Desidustat in Anemia due to Dialysis-Dependent Chronic Kidney Disease']","['epoetin', 'epoetin alfa subcutaneous injection', 'epoetin alfa group', 'epoetin alfa']","['least square mean (standard error) change in hemoglobin', 'hemoglobin level', 'number of hemoglobin responders', 'number of patients with hemoglobin response', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C5198569', 'cui_str': 'desidustat'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",392.0,0.0473271,"There were no new risks or no increased risks seen with the use of desidustat compared to epoetin alfa.
","[{'ForeName': 'Sishir', 'Initials': 'S', 'LastName': 'Gang', 'Affiliation': 'Muljibhai Patel Urology Hospital, Nadiad, India.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Khetan', 'Affiliation': 'Shravan Hospital and Kidney Institute, Nagpur, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Varade', 'Affiliation': 'Asian Institute of Medical Sciences, Dombivli, India.'}, {'ForeName': 'Venkata Ramakrishna', 'Initials': 'VR', 'LastName': 'Chinta', 'Affiliation': 'Vedanta Hospital, Guntur, India.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Mavani', 'Affiliation': 'Mavani Dialysis and Kidney Center, Ahmedabad, India.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Gupta', 'Affiliation': 'Department of Nephrology, Aakash Healthcare Super Specialty Hospital, New Delhi, India.'}, {'ForeName': 'S Venkata Krishna', 'Initials': 'SVK', 'LastName': 'Reddy', 'Affiliation': 'Vijaya Super Speciality Hospital, Nellore, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Rajanna', 'Affiliation': 'Department of Nephrology, Kempegowda Institute of Medical Sciences Hospital and Research Center, Bengaluru, India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Jeloka', 'Affiliation': 'Aditya Birla Memorial Hospital, Pimpri-Chinchwad, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Ruhela', 'Affiliation': 'Department of Nephrology, Shri Mahant Indiresh Hospital, Dehradun, India.'}, {'ForeName': 'Kevinkumar', 'Initials': 'K', 'LastName': 'Kansagra', 'Affiliation': 'Zydus Research Center, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Kanani', 'Affiliation': 'Zydus Research Center, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Bhatt', 'Affiliation': 'Zydus Research Center, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Kuldipsinh', 'Initials': 'K', 'LastName': 'Zala', 'Affiliation': 'Zydus Research Center, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000523949']
878,35466411,Open-label pilot study of ranolazine for cramps in amyotrophic lateral sclerosis.,"INTRODUCTION/AIMS


Neuronal hyperexcitability (manifested by cramps) plays a pathological role in amyotrophic lateral sclerosis (ALS), and drugs affecting it may help symptomatic management and slow disease progression. We aimed to determine safety and tolerability of two doses of ranolazine in patients with ALS and evaluate for preliminary evidence of drug-target engagement by assessing muscle cramp characteristics.
METHODS


We performed an open-label dose-ascending study of ranolazine in 14 individuals with ALS in two sequential cohorts: 500 mg (cohort 1) and 1000 mg (cohort 2) orally twice daily. Each had a 2-week run-in period, 4-week drug administration, and 6-week safety follow-up. Primary outcome was safety and tolerability. Exploratory measures included cramp frequency and severity, fasciculation frequency, cramp potential duration, ALS Functional Rating Scale---Revised score, and forced vital capacity.
RESULTS


Six and eight participants were enrolled in cohorts 1 and 2, respectively. There were no serious adverse events. Two subjects in cohort 2 discontinued the drug due to constipation. The most frequent drug-related adverse event was gastrointestinal (40%). Cramp frequency decreased by 54.8% (95% confidence interval [CI], 39%-70.8%) and severity decreased by 46.3% (95% CI, 29.5-63.3%), which appeared to be dose-dependent, with decreased awakening due to cramps. Other outcomes showed no change.
DISCUSSION


Ranolazine was well tolerated in ALS up to 2000 mg/day, with gastrointestinal side effects being the most frequent. Ranolazine reduced cramp frequency and severity, supporting its investigation for muscle cramps in a future placebo-controlled trial.",2022,"Cramp frequency decreased by 54.8% (95% CI 39 to 70.8%) and severity decreased by 46.3% (95% CI 29.5 to 63.3%), which appeared to be dose-dependent, with decreased awakening due to cramps.","['Amyotrophic Lateral Sclerosis', 'Two subjects in cohort 2 discontinued the drug due to constipation', '14 individuals with ALS in 2 sequential cohorts', 'patients with ALS']","['ranolazine', 'Ranolazine']","['severity', 'safety and tolerability', 'serious adverse events', 'Cramp frequency', 'cramp frequency and severity, fasciculation frequency, cramp potential duration, ALS Functional Rating Scale-revised, and forced vital capacity']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0073633', 'cui_str': 'ranolazine'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015644', 'cui_str': 'Muscle fasciculation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",14.0,0.0529493,"Cramp frequency decreased by 54.8% (95% CI 39 to 70.8%) and severity decreased by 46.3% (95% CI 29.5 to 63.3%), which appeared to be dose-dependent, with decreased awakening due to cramps.","[{'ForeName': 'Swathy', 'Initials': 'S', 'LastName': 'Chandrashekhar', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Anai C', 'Initials': 'AC', 'LastName': 'Hamasaki', 'Affiliation': 'Department of Neurology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Clay', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Ayla', 'Initials': 'A', 'LastName': 'McCalley', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Herbelin', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Jawdat', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Mazen M', 'Initials': 'MM', 'LastName': 'Dimachkie', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, University of Missouri System, Columbia, Missouri.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Statland', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas.'}]",Muscle & nerve,['10.1002/mus.27560']
879,35468736,The experience of participating in an internet-based cognitive behavioral therapy program among patients with cardiovascular disease and depression: a qualitative interview study.,"BACKGROUND


Depression in conjunction with cardiovascular disease (CVD) is associated with worsening in CVD, higher mortality, and poorer quality of life. Despite the poor outcomes there is a treatment gap of depression in CVD patients. Recently we found that an Internet-based cognitive behavioral therapy (iCBT) tailored for CVD patients led to reduced symptoms of depression. However, we still have little knowledge about CVD patients' experiences of working with iCBT. The aim of this study was therefore to explore CVD patients' experiences of engaging in a tailored iCBT program.
METHODS


A qualitative interview study using inductive thematic analysis. Data was obtained from 20 patients with CVD and depressive symptoms who had participated in a randomized controlled trial (RCT) evaluating the impact of a nine-week iCBT program on depression.
RESULTS


Three main themes emerged: (1) Taking control of the disease, (2) Not just a walk in the park, and (3) Feeling a personal engagement with the iCBT program. The first theme included comments that the tailored program gave the patients a feeling of being active in the treatment process and helped them achieve changes in thoughts and behaviors necessary to take control of their CVD. The second theme showed that patients also experienced the program as demanding and emotionally challenging. However, it was viewed as helpful to challenge negative thinking about living with CVD and to change depressive thoughts. In the third theme patients reported that the structure inherent in the program, in the form of organizing their own health and the scheduled feedback from the therapist created a feeling of being seen as an individual. The feeling of being acknowledged as a person also made it easier to continuously work with the changes necessary to improve their health.
CONCLUSIONS


Engaging in an iCBT program tailored for patients with CVD and depression was by the patients perceived as helpful in the treatment of depression. They experienced positive changes in emotions, thoughts, and behaviors which a result of learning to take control of their CVD, being confirmed and getting support. The patients considered working with the iCBT program as demanding and emotionally challenging, but necessary to achieve changes in emotions, thoughts, and behaviors.",2022,Engaging in an iCBT program tailored for patients with CVD and depression was by the patients perceived as helpful in the treatment of depression.,"['CVD patients', ""CVD patients' experiences of engaging in a tailored iCBT program"", 'patients with cardiovascular disease and depression', '20 patients with CVD and depressive symptoms who had participated']","['internet-based cognitive behavioral therapy program', 'Internet-based cognitive behavioral therapy (iCBT', 'iCBT program']","['emotions, thoughts, and behaviors']","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",20.0,0.0306797,Engaging in an iCBT program tailored for patients with CVD and depression was by the patients perceived as helpful in the treatment of depression.,"[{'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Westas', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden. mats.westas@liu.se.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'Mourad', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Neher', 'Affiliation': 'Department of Rehabilitation, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johansson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}]",BMC psychiatry,['10.1186/s12888-022-03939-7']
880,35470916,"Effects of crocin supplementation on inflammatory markers, lipid profiles, insulin and cardioprotective indices in women with PCOS: A randomized, double-blind, placebo-controlled trial.","Polycystic ovary syndrome (PCOS) is a multifactorial reproductive condition common in women of reproductive age. Hyperlipidemia, insulin resistance, obesity, and chronic low-grade inflammation are associated with PCOS. In a clinical trial study, women with PCOS were divided into two groups (n = 25 each): the intervention group receiving crocin (15 mg, twice daily) and the control group receiving a placebo. The duration of intervention in both groups was 12 weeks. Pre- and postintervention, demographic information, lipid profile, fasting blood glucose (FBG), fasting insulin, and inflammatory markers (interleukin-6 [IL-6] and tumor necrosis factor-alpha [TNF-α]) were measured. Intervention with crocin significantly increased the mean high-density lipoprotein cholesterol postintervention compared to the placebo group, while exerting a suppressive effect on the increase in mean low-density lipoprotein cholesterol, triglycerides, and cholesterol levels. Intervention with crocin also exerted inhibitory effects on changes in FBG and insulin, so that crocin improved insulin and cardioprotective indices. Finally, despite the increased inflammatory markers (IL-6 and TNF-α) in the placebo group, crocin treatment had protective effects on their increased changes. Thus, crocin supplementation could be considered in the therapeutic targets of women with PCOS.",2022,"Finally, despite the increased inflammatory markers (IL-6 and TNF-α) in the placebo group, crocin treatment had protective effects on their increased changes.","['women with PCOS', 'women of reproductive age', 'Polycystic ovary syndrome (PCOS']","['placebo', 'crocin supplementation', 'control group receiving a placebo', 'intervention group receiving crocin']","['Hyperlipidemia, insulin resistance, obesity, and chronic low-grade inflammation', 'fasting blood glucose (FBG), fasting insulin, and inflammatory markers (interleukin-6 [IL-6] and tumor necrosis factor-alpha [TNF-α', 'mean high-density lipoprotein cholesterol postintervention', 'inflammatory markers (IL-6 and TNF-α', 'inflammatory markers, lipid profiles, insulin and cardioprotective indices', 'Pre- and postintervention, demographic information, lipid profile', 'mean low-density lipoprotein cholesterol, triglycerides, and cholesterol levels', 'duration of intervention']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0056503', 'cui_str': 'crocin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.216767,"Finally, despite the increased inflammatory markers (IL-6 and TNF-α) in the placebo group, crocin treatment had protective effects on their increased changes.","[{'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Rahimi', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Shams', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Aslani', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.7474']
881,35472058,Protocol for a randomized controlled trial comparing the Circle of Security-parenting (COS-P) with treatment as usual in child mental health services.,"BACKGROUND


The quality of a child's attachment to its primary caregiver plays an important role for its long-term socioemotional development. While 'secure' attachment is associated with better outcomes, 'insecure' attachment is associated with a higher risk of externalizing and internalizing symptoms. Children referred to mental health services show much higher rates of insecure attachment than the general population, yet the parent-child relationship is rarely in treatment focus. Attachment quality is closely associated with parental sensitive responsiveness that is target of attachment-based interventions like Circle of Security (COS). COS has shown to improve attachment quality and the well-being of both children and parents. No randomized controlled trials have investigated the effect of COS on parental sensitivity and child psychiatric symptoms in child mental health services.
OBJECTIVES


To investigate whether COS-Parenting (COS-P) can increase observed maternal sensitivity and decrease children's psychiatric symptoms as an add on to treatment as usual (TAU).
METHODS


In a randomized controlled parallel superiority trial COS-P is compared with TAU for parents of children referred to child mental health services (n = 186). Families are randomized 2:1 to intervention or control group, if their child is between 3 and 8 years old and scores ≥ 93d percentile on both the CBCL total score and the oppositional defiant disorder or conduct disorder subscale. Primary outcome is maternal sensitivity, secondary and exploratory outcomes include, among others, child psychiatric symptoms, parental stress and coping with children's negative emotions. Outcomes and adverse events are assessed before (T0) and after 10 weeks of treatment (T1) and 6 months later (T2). Regression analysis and /or ANOVA will be used for all outcomes.
PERSPECTIVES


Targeting the parent-child relation has the potential to reduce psychiatric symptoms in children. This trial will provide valuable information if attachment-based interventions like COS-P can enhance treatment as usual in child mental health services.
TRAIL REGISTRATION


ClinicalTrials.gov Identifier: NCT03578016.",2022,In a randomized controlled parallel superiority trial COS-P is compared with TAU for parents of children referred to child mental health services (n = 186).,"['parents of children referred to child mental health services (n = 186', 'child mental health services', 'children']","['Circle of Security-parenting (COS-P', 'COS-Parenting (COS-P', 'COS', 'TAU']","[""maternal sensitivity, secondary and exploratory outcomes include, among others, child psychiatric symptoms, parental stress and coping with children's negative emotions"", 'parental sensitivity and child psychiatric symptoms', 'adverse events', 'attachment quality', 'CBCL total score and the oppositional defiant disorder or conduct disorder subscale', ""maternal sensitivity and decrease children's psychiatric symptoms""]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]","[{'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct disorder'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",186.0,0.185749,In a randomized controlled parallel superiority trial COS-P is compared with TAU for parents of children referred to child mental health services (n = 186).,"[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Bikic', 'Affiliation': 'Child and Adolescent Mental Health Services Southern Jutland, Aabenraa, Region of Southern Denmark, Denmark.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Smith-Nielsen', 'Affiliation': 'Department of Psychology, Centre for Early Intervention and Family Studies, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Dalsgaard', 'Affiliation': 'Department of Economics and Business, National Centre of Register-Based Research, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Swain', 'Affiliation': 'Department of Psychiatry and Behavioral Health, and Psychology, Stony Brook University, Stony Brook, NY, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Leckman', 'Affiliation': 'Child Study Centre, Yale University School of Medicine, New Haven, Connecticut, United States of America.'}]",PloS one,['10.1371/journal.pone.0265676']
882,35472008,Proton pump inhibition for secondary hemochromatosis in hereditary anemia: a phase III placebo-controlled randomized cross-over clinical trial.,"Iron overload is a severe general complication of hereditary anemias. Treatment with iron chelators is hampered by important side-effects, high costs, and the lack of availability in many countries with a high prevalence of hereditary anemias. In this phase III randomized placebo-controlled trial, we assigned adults with non-transfusion-dependent hereditary anemias with mild-to-moderate iron overload to receive esomeprazole (at a dose of 40 mg twice daily) or placebo for 12 months in a cross-over design. The primary end point was change of liver iron content measured by MRI. A total of 30 participants were enrolled in the trial. Treatment with esomeprazole resulted in a statistically significant reduction in liver iron content that was 0.55 mg Fe/g dw larger than after treatment with placebo (95%CI [0.05 to 1.06]; p = 0.03). Median baseline liver iron content at the start of esomeprazole was 4.99 versus 4.49 mg Fe/g dw at start of placebo. Mean delta liver iron content after esomeprazole treatment was -0.57 (SD 1.20) versus -0.11 mg Fe/g dw (SD 0.75) after placebo treatment. Esomeprazole was well tolerated, reported adverse events were mild and none of the patients withdrew from the study due to side effects. In summary, esomeprazole resulted in a significant reduction in liver iron content when compared to placebo in a heterogeneous group of patients with non-transfusion-dependent hereditary anemias. From an international perspective this result can have major implications given the fact that proton pump inhibitors may frequently be the only realistic therapy for many patients without access to or not tolerating iron chelators.",2022,Treatment with esomeprazole resulted in a statistically significant reduction in liver iron content that was 0.55 mg,"['adults with non-transfusion-dependent hereditary anemias with mild-to-moderate iron overload to receive', 'A total of thirty participants were enrolled in the trial', 'hereditary anemia']","['placebo', 'Esomeprazole', 'Proton pump inhibition', 'esomeprazole']","['change of liver iron content measured by MRI', 'Mean delta liver iron content', 'adverse events', 'liver iron content', 'Median baseline liver iron content']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0282193', 'cui_str': 'Iron overload'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0018440', 'cui_str': 'Proton Pump'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",30.0,0.281992,Treatment with esomeprazole resulted in a statistically significant reduction in liver iron content that was 0.55 mg,"[{'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'van Vuren', 'Affiliation': 'Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jean Louis', 'Initials': 'JL', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Hematology, HagaZiekenhuis, The Hague, The Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Schols', 'Affiliation': 'Department of Hematology, Radboud university medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Rijneveld', 'Affiliation': 'Department of Hematology, Erasmus Medical Center Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Nur', 'Affiliation': 'Department of Hematology, Amsterdam University Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dore', 'Initials': 'D', 'LastName': 'Peereboom', 'Affiliation': 'Contactgroep Pyruvaatkinasedeficiëntie, Stichting Zeldzame Bloedziekten, Medemblik, The Netherlands.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Gandon', 'Affiliation': 'Department of Radiology, CHU Rennes, University of Rennes, Rennes, France.'}, {'ForeName': 'Paco', 'Initials': 'P', 'LastName': 'Welsing', 'Affiliation': 'Division of Internal Medicine and Dermatology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Wijk', 'Affiliation': 'Central Diagnostic Laboratory - Research, Division of Laboratories, Pharmacy and Biomedical Genetics, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Schutgens', 'Affiliation': 'Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'van Solinge', 'Affiliation': 'Central Diagnostic Laboratory - Research, Division of Laboratories, Pharmacy and Biomedical Genetics, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Joannes', 'Initials': 'J', 'LastName': 'Marx', 'Affiliation': 'University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Leiner', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Biemond', 'Affiliation': 'Department of Hematology, Amsterdam University Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'van Beers', 'Affiliation': 'Center for Benign Haematology, Thrombosis and Haemostasis, Van Creveldkliniek, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",American journal of hematology,['10.1002/ajh.26581']
883,35474254,Effect of menopausal hormone therapy on arterial wall echomorphology: Results from the Early versus Late Intervention Trial with Estradiol (ELITE).,"OBJECTIVE


To evaluate the effect of hormone therapy (HT) on arterial wall composition by ultrasound.
BACKGROUND


The effect of HT on the progression of subclinical atherosclerosis has been well-described using measurements of common carotid artery (CCA) wall thickness. However, it is unknown whether the change in arterial wall anatomic structure is accompanied by an effect of HT on arterial wall composition.
METHODS


A total of 643 healthy postmenopausal women divided into two strata according to the time since menopause (<6 years, the early-postmenopause group; or >10 years, the late-postmenopause group) were randomized to receive either active treatment or placebo. For hysterectomized women, the active treatment was oral micronized 17β-estradiol 1 mg/day; for women with a uterus, 4% vaginal micronized progesterone gel 45 mg/day for 10 days each month was added to the estradiol regimen. Gray-scale median of the CCA intima-media complex (IM-GSM), a (unitless) measurement of arterial wall composition based on echogenicity, was determined by high-resolution B-mode ultrasonography. Lower IM-GSM, or less echogenicity, indicates more atherosclerosis. IM-GSM and serum estradiol (E2) concentration were assessed every 6 months over a median 4.8-year trial period. Linear mixed effects regression models were used for all analyses.
RESULTS


Overall, IM-GSM progression/year had a negative trajectory, reflecting reduction in echogenicity over time (worsening atherosclerosis). HT effects on IM-GSM progression/year differed by postmenopause strata (interaction p-value = 0.02). IM-GSM progression/year (95% CI) in the early postmenopause group randomized to HT was -0.50 (-0.82, -0.18)/year compared with -1.47 (-1.81, -1.13)/year among those randomized to placebo (p-value <0.0001). In the late postmenopause group, the annual IM-GSM progression rate did not significantly differ between HT and placebo (p = 0.28). Higher mean on-trial E2 (pg/ml) levels were associated with higher IM-GSM progression, indicating less atherosclerosis progression in all women (β (95% CI) = 0.006 (0.0003, 0.01), p = 0.04). For each pg/dl E2, IM-GSM progression/year was 0.007 ((-0.0002, 0.01), p = 0.056) in the early and 0.003 ((-0.006, 0.01), p = 0.50) in the late postmenopause group (interaction p-value = 0.51). CIMT progression rate (μm/year) was significantly inversely associated with the IM-GSM progression (β (95% CI) = -4.63 (-5.6, -3.7), p < 0.001).
CONCLUSIONS


HT, primarily with oral estradiol, reduced atherogenic progression of arterial wall composition in healthy postmenopausal women who were within 6 years from menopause.
TRIAL REGISTRATION NUMBER


NCT01553084.",2022,"In the late postmenopause group, the annual IM-GSM progression rate did not significantly differ between HT and placebo (p = 0.28).","['arterial wall echomorphology', '643 healthy postmenopausal women divided into two strata according to the time since menopause (<6\xa0years, the early-postmenopause group; or >10\xa0years, the late-postmenopause group', 'healthy postmenopausal women who were within 6\xa0years from menopause', 'For hysterectomized women']","['vaginal micronized progesterone gel', 'oral estradiol', 'HT', 'hormone therapy (HT', '17β-estradiol', 'menopausal hormone therapy', 'placebo', 'active treatment or placebo', 'IM-GSM and serum estradiol', 'micronized']","['CIMT progression rate', 'atherosclerosis progression', 'annual IM-GSM progression rate', 'echogenicity over time (worsening atherosclerosis', 'atherogenic progression of arterial wall composition', 'E2) concentration']","[{'cui': 'C0507850', 'cui_str': 'Wall of artery'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206159', 'cui_str': 'Postmenopause'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1300564', 'cui_str': 'g/m2'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C1300564', 'cui_str': 'g/m2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0507850', 'cui_str': 'Wall of artery'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",643.0,0.113428,"In the late postmenopause group, the annual IM-GSM progression rate did not significantly differ between HT and placebo (p = 0.28).","[{'ForeName': 'Roksana', 'Initials': 'R', 'LastName': 'Karim', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America; Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: rkarim@usc.edu.'}, {'ForeName': 'Wenrui', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: wenrui@usc.edu.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kono', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America; Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: kono@usc.edu.'}, {'ForeName': 'Intira', 'Initials': 'I', 'LastName': 'Sriprasert', 'Affiliation': 'Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: sriprase@usc.edu.'}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: yanli@usc.edu.'}, {'ForeName': 'Mingzhu', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: mingzhuy@usc.edu.'}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': 'Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shoupe', 'Affiliation': 'Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: shoupe@usc.edu.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America; Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: wmack@usc.edu.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America; Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America; Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: athero@usc.edu.'}]",Maturitas,['10.1016/j.maturitas.2022.02.007']
884,35474187,"Re: A randomized, double-blind, placebo-controlled pilot study of the comparative effects of dienogest and the combined oral contraceptive pill in women with endometriosis.",,2022,,['women with endometriosis'],"['placebo', 'dienogest and the combined oral contraceptive pill']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]",[],,0.491648,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hirsch', 'Affiliation': ""Oxford Endometriosis CaRe Centre, Nuffield Department of Women's & Reproductive Health,, University of Oxford, Oxford, UK.""}, {'ForeName': 'James M N', 'Initials': 'JMN', 'LastName': 'Duffy', 'Affiliation': ""Oxford Endometriosis CaRe Centre, Nuffield Department of Women's & Reproductive Health,, University of Oxford, Oxford, UK.""}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Farquhar', 'Affiliation': 'Cochrane Gynaecology and Fertility Group, Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.14188']
885,35477046,Topographical changes and bactericidal efficacy of antimicrobial photodynamic therapy on titanium implant surface.,"BACKGROUND


reExtensive rsearch has been done on various disinfection modalities used to achieve an aseptic implant surface. However, the bacterial efficacy and the topographical alterations resulting from the use of these techniques have never been compared.
OBJECTIVE


This study aimed to evaluate and compare the disinfection efficacy and surface changes on a bacteria contaminated titanium block following application of various disinfectants.
METHOD


Ultrasonically cleaned titanium blocks were contaminated with Porphyromonas gingivalis and Tannerella forsythia. The infected titanium implants were randomly divided into four experimental groups and decontaminated using antimicrobial photodynamic therapy (aPDT), laser therapy, chlorhexidine and hydrogen peroxide. Bacterial viability and surface changes following decontamination were analyzed.
RESULT


Bacterial viability decreased in all the groups, with aPDT having the highest reduction. Surface roughness remained unchanged whereas the contact angle lessened in the aPDT group.
CONCLUSION


aPDT could possibly be a suitable alternative to other disinfection regimen to treat periimplantitis.",2022,"Surface roughness remained unchanged whereas the contact angle lessened in the aPDT group.
",[],"['antimicrobial photodynamic therapy (aPDT), laser therapy, chlorhexidine and hydrogen peroxide', 'antimicrobial photodynamic therapy']","['Bacterial viability and surface changes', 'Bacterial viability', 'Surface roughness', 'titanium implant surface', 'Topographical changes and bactericidal efficacy']",[],"[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C1563772', 'cui_str': 'Bacteria Viability'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0151892,"Surface roughness remained unchanged whereas the contact angle lessened in the aPDT group.
","[{'ForeName': 'Sukumaran', 'Initials': 'S', 'LastName': 'Anil', 'Affiliation': 'Department of Dentistry-Oral Health Institute, Hamad Medical Corporation, Doha, Qatar; College of Dental Medicine, Qatar University, Doha, Qatar. Electronic address: drsanil@gmail.com.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Alageel', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh, 11433, Saudi Arabia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Alsadon', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh, 11433, Saudi Arabia.'}, {'ForeName': 'Samer M', 'Initials': 'SM', 'LastName': 'Alaqeel', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh, 11433, Saudi Arabia.'}, {'ForeName': 'Majed M', 'Initials': 'MM', 'LastName': 'Alsarani', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh, 11433, Saudi Arabia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hashem', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh, 11433, Saudi Arabia.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Fouad', 'Affiliation': 'Applied Medical Science Department, CC, King Saud University, P.O Box 10219, Riyadh, 11433, Saudi Arabia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Javaid', 'Affiliation': 'School of Dentistry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2022.102882']
886,35484019,Behavioral activation for depression delivered by drug and alcohol treatment workers: A pilot randomized controlled trial.,"BACKGROUND


One in two patients seeking help for substance use disorders (SUDs) has clinically significant depression symptoms. This co-occurrence impairs treatment outcomes, but limited evaluation of the implementation of evidence-based interventions has taken place.
METHODS


This pilot randomized controlled trial (RCT) assessed the feasibility and potential efficacy of a brief, protocol-driven behavioral activation (BA) intervention delivered by drug and alcohol workers in a community drug and alcohol treatment (CDAT) service. Eligible participants (n = 34) were randomly allocated to either BA (n = 17) or treatment as usual (n = 17) and assessed at baseline and 6-, 12-, and 24-week follow-up. Feasibility outcomes were participant engagement and worker protocol adherence. The primary pilot outcome was severity of depression symptoms (PHQ-9) at 12-week follow-up. Secondary outcomes included percent days abstinent (PDA) in the past month, severity of dependence (SDS), anxiety symptoms (GAD-7), and valued living (VQ) at all follow-up points.
RESULTS


Fifty-nine percent of BA participants attended at least one session and there was 95% adherence to the treatment protocol. BA was associated with significantly reduced depression at 12-week follow-up (PHQ-9 mean difference - 5.69, 95% CI -10.07 to -1.31). BA participants had significantly greater improvements in PDA (mean difference 17.9, 95% CI 0.99 to 34.82) and VQ-Progress (mean difference 5.34, 95% CI 1.47 to 9.22) at 6-week follow-up and PDA (mean difference 27.69, 95% CI 4.44 o 50.95) at 12-week follow-up. The study found no significant between-group differences at 24-week follow-up.
CONCLUSION


BA implemented by drug and alcohol treatment workers in CDAT appears feasible and may add clinical benefit to usual care for SUD patients with elevated depressive symptoms accessing CDAT. Fully powered RCTs are warranted to better investigate the replicability of these preliminary findings. Methodological limitations are discussed and suggestions for future research are provided.",2022,BA was associated with significantly reduced depression at 12-week follow-up,"['Eligible participants (n\xa0=\xa034', 'SUD patients with elevated depressive symptoms accessing CDAT', 'depression delivered by drug and alcohol treatment workers', 'alcohol workers in a community drug and alcohol treatment (CDAT) service']","['protocol-driven behavioral activation (BA) intervention', 'BA']","['percent days abstinent (PDA) in the past month, severity of dependence (SDS), anxiety symptoms (GAD-7), and valued living (VQ', 'severity of depression symptoms (PHQ-9', 'PDA', 'VQ-Progress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",34.0,0.293902,BA was associated with significantly reduced depression at 12-week follow-up,"[{'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'Pott', 'Affiliation': 'Department of Psychology, University of Sheffield, UK. Electronic address: slpott1@sheffield.ac.uk.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kellett', 'Affiliation': 'Department of Psychology, University of Sheffield, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Green', 'Affiliation': 'Rotherham Doncaster and South Humber NHS Foundation Trust, UK.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Daughters', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Delgadillo', 'Affiliation': 'Department of Psychology, University of Sheffield, UK.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2022.108769']
887,35485234,Effects of a person-centred and thriving-promoting intervention on nursing home residents' experiences of thriving and person-centredness of the environment.,"AIM


To evaluate the effects of a person-centred and thriving-promoting intervention on nursing home residents´ experiences of thriving and person-centredness of the environment, and to evaluate if the effects varied between female and male residents.
DESIGN


A multi-centre, non-equivalent controlled group before-after intervention design.
METHODS


Six nursing homes in Australia, Norway and Sweden were allocated to either intervention or control group. The intervention comprised a staff educational programme. A survey using proxy-ratings by staff was administered before (T0), immediately after (T1) and six months after (T2) the intervention. The sample varied between 205 and 292 residents. Linear regression models were used to explore effects.
RESULTS


Statistically significant effects were found on experiences of thriving and person-centredness of the environment. These effects were significant for male residents but not for female residents. The results emphasize the importance of individually tailored social and recreational activities.",2022,Statistically significant effects were found on experiences of thriving and person-centredness of the environment.,"['Six nursing homes in Australia, Norway and Sweden', 'male residents but not for female residents', 'female and male residents', 'The sample varied between 205 and 292 residents', ""nursing home residents' experiences of thriving and person-centredness of the environment""]","['person-centred and thriving-promoting intervention', 'staff educational programme']",[],"[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",[],,0.00749192,Statistically significant effects were found on experiences of thriving and person-centredness of the environment.,"[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Sjögren', 'Affiliation': 'Department of Nursing, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ådel', 'Initials': 'Å', 'LastName': 'Bergland', 'Affiliation': 'Lovisenberg Diaconal University College, Oslo, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Kirkevold', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, Institute of Health and Society, Oslo University, Oslo, Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lindkvist', 'Affiliation': 'Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Qarin', 'Initials': 'Q', 'LastName': 'Lood', 'Affiliation': 'Department of Nursing, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per-Olof', 'Initials': 'PO', 'LastName': 'Sandman', 'Affiliation': 'Department of Nursing, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Tove Karin', 'Initials': 'TK', 'LastName': 'Vassbø', 'Affiliation': 'Lovisenberg Diaconal University College, Oslo, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edvardsson', 'Affiliation': 'Department of Nursing, Umeå University, Umeå, Sweden.'}]",Nursing open,['10.1002/nop2.1222']
888,35490438,Sleep restriction alters cortical inhibition in migraine: A transcranial magnetic stimulation study.,"OBJECTIVE


Migraine is a primary headache disorder with a well-known association with insufficient sleep. However, both the underlying pathophysiology of the disease and the relationship with sleep is still unexplained. In this study, we apply transcranial magnetic stimulation to investigate possible mechanisms of insufficient sleep in migraine.
METHODS


We used a randomised, blinded crossover design to examine 46 subjects with migraine during the interictal period and 29 healthy controls. Each subject underwent recordings of cortical silent period, short- and long-interval intracortical inhibition, intracortical facilitation and short-latency afferent inhibition after both two nights of habitual eight-hour sleep and two nights of restricted four-hour sleep.
RESULTS


We found reduced cortical silent period duration after sleep restriction in interictal migraineurs compared to controls (p = 0.046). This effect was more pronounced for non-sleep related migraine (p = 0.002) and migraine with aura (p = 0.017). The sleep restriction effect was associated with ictal symptoms of hypersensitivity such as photophobia (p = 0.017) and overall silent period was associated with premonitory dopaminergic symptoms such as yawning (p = 0.034).
CONCLUSIONS


Sleep restriction reduces GABAergic cortical inhibition during the interictal period in individuals with migraine.
SIGNIFICANCE


Sleep related mechanisms appear to affect the pathophysiology of migraine and may differentiate between migraine subgroups.",2022,We found reduced cortical silent period duration after sleep restriction in interictal migraineurs compared to controls (p = 0.046).,"['46 subjects with migraine during the interictal period and 29 healthy controls', 'individuals with migraine', 'migraine']","['Sleep restriction', 'transcranial magnetic stimulation']","['ictal symptoms of hypersensitivity such as photophobia', 'GABAergic cortical inhibition', 'sleep restriction effect']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0085636', 'cui_str': 'Photophobia'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",46.0,0.0356333,We found reduced cortical silent period duration after sleep restriction in interictal migraineurs compared to controls (p = 0.046).,"[{'ForeName': 'Martin Syvertsen', 'Initials': 'MS', 'LastName': 'Mykland', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway. Electronic address: martin.s.mykland@ntnu.no.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Uglem', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Jan Petter', 'Initials': 'JP', 'LastName': 'Neverdahl', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Lise Rystad', 'Initials': 'LR', 'LastName': 'Øie', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Tore Wergeland', 'Initials': 'TW', 'LastName': 'Meisingset', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic Arizona, Scottsdale, AZ, USA.'}, {'ForeName': 'Erling', 'Initials': 'E', 'LastName': 'Tronvik', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Sand', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Petter Moe', 'Initials': 'PM', 'LastName': 'Omland', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2022.04.004']
889,35490437,EEG recording latency in critically ill patients: Impact on outcome. An analysis of a randomized controlled trial (CERTA).,"OBJECTIVE


To assess, in adults with acute consciousness impairment, the impact of latency between hospital admission and EEG recording start, and their outcome.
METHODS


We reviewed data of the CERTA trial (NCT03129438) and explored correlations between EEG recording latency and mortality, Cerebral Performance Categories (CPC), and modified Rankin Scale (mRS) at 6 months, considering other variables, using uni- and multivariable analyses.
RESULTS


In univariable analysis of 364 adults, median latency between admission and EEG recordings was comparable between surviving (61.1 h; IQR: 24.3-137.7) and deceased patients (57.5 h; IQR: 22.3-141.1); p = 0.727. This did not change after adjusting for potential confounders, such as lower Glasgow Coma Score on enrolment (p < 0.001) and seizure or status epilepticus detection (p < 0.001). There was neither any correlation between EEG latency and mRS (rho 0.087, p 0.236), nor with CPC (rho = 0.027, p = 0.603).
CONCLUSION


This analysis shows no correlation between delays of EEG recordings and mortality or functional outcomes at 6 months in critically ill adults.
SIGNIFICANCE


These findings might suggest that in critically ill adults mortality correlates with underlying brain injury rather than EEG delay.",2022,"There was neither any correlation between EEG latency and mRS (rho 0.087, p 0.236), nor with CPC (rho = 0.027, p = 0.603).
","['critically ill patients', 'adults with acute consciousness impairment', 'critically ill adults']",[],"['EEG recording latency and mortality, Cerebral Performance Categories (CPC), and modified Rankin Scale (mRS', 'EEG latency and mRS', 'lower Glasgow Coma Score', 'median latency between admission and EEG recordings', 'seizure or status epilepticus detection']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",[],"[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",364.0,0.250497,"There was neither any correlation between EEG latency and mRS (rho 0.087, p 0.236), nor with CPC (rho = 0.027, p = 0.603).
","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Urbano', 'Affiliation': 'Department of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Novy', 'Affiliation': 'Department of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Alvarez', 'Affiliation': 'Department of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland; Department of Neurology, Hôpital du Valais, Sion, Switzerland.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Schindler', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rüegg', 'Affiliation': 'Department of Neurology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Andrea O', 'Initials': 'AO', 'LastName': 'Rossetti', 'Affiliation': 'Department of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland. Electronic address: andrea.rossetti@chuv.ch.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2022.04.003']
890,35460410,"Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial).","OBJECTIVE


To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions.
DESIGN AND SETTING


Multicenter, open-label parallel randomised controlled trial involving 39 Australian aged-care facilities.
PARTICIPANTS


Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine.
INTERVENTION


Pharmacist-led intervention using validated tools to detect signs and symptoms of medicine-induced deterioration which occurred every 8 weeks over 12 months.
COMPARATOR


Usual care (Residential Medication Management Review) provided by accredited pharmacists.
OUTCOMES


Primary outcome was change in Frailty Index at 12 months. Secondary outcomes included changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life.
RESULTS


248 persons (median age 87 years) completed the study; 120 in the interventionand, 128 in control arms. In total 575 pharmacist, sessions were undertaken in the intervention arm. There was no statistically significant difference for change in frailty between groups (mean difference: 0.009, 95% CI: -0.028, 0.009, P = 0.320). A significant difference for cognition was observed, with a mean difference of 1.36 point change at 12 months (95% CI: 0.01, 2.72, P = 0.048). Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups. Point estimates favoured the intervention arm at 12 months for frailty, 24-hour movement behaviour and grip strength.
CONCLUSIONS


The use of validated tools by pharmacists to detect signs of medicine-induced deterioration is a model of practice that requires further research, with promising results from this trial, particularly with regards to improved cognition.",2022,"Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups.","['248 persons (median age 87\xa0years) completed the study; 120 in the interventionand, 128 in control arms', 'Residents on ≥4 medicines or\u2009≥1 anticholinergic or sedative medicine', 'aged-care facilities (nursing homes', '39 Australian aged-care facilities']",['pharmacist-led intervention'],"['frailty, 24-hour movement behaviour and grip strength', 'change in Frailty Index', '24-hour movement behaviour, grip strength, adverse events and quality of life', 'cognition', 'changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",39.0,0.0886373,"Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups.","[{'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Roughead', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Pratt', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Gaynor', 'Initials': 'G', 'LastName': 'Parfitt', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, UniSA Allied Health & Human Performance, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Rowett', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kalisch-Ellett', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bereznicki', 'Affiliation': 'School of Medicine, University of Tasmania, Tasmania, TAS, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Merlin', 'Affiliation': 'Adelaide Health Technology Assessment, School of Public Health, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Corlis', 'Affiliation': 'Australian Nursing and Midwifery Federation (SA Branch), Ridleyton, SA, Australia.'}, {'ForeName': 'Ai Choo', 'Initials': 'AC', 'LastName': 'Kang', 'Affiliation': 'University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Whitehouse', 'Affiliation': 'Pharmacy Improvement Centre Ltd, Welland, SA, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bilton', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Schubert', 'Affiliation': 'Adelaide Health Technology Assessment, School of Public Health, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Torode', 'Affiliation': 'University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Thu-Lan', 'Initials': 'TL', 'LastName': 'Kelly', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Andre Q', 'Initials': 'AQ', 'LastName': 'Andrade', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Dannielle', 'Initials': 'D', 'LastName': 'Post', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, UniSA Allied Health & Human Performance, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Gereltuya', 'Initials': 'G', 'LastName': 'Dorj', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Cousins', 'Affiliation': 'School of Medicine, University of Tasmania, Tasmania, TAS, Australia.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'School of Medicine, University of Tasmania, Tasmania, TAS, Australia.'}, {'ForeName': 'Renly', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}]",Age and ageing,['10.1093/ageing/afac092']
891,35465686,Vitamin K2 and D in Patients With Aortic Valve Calcification: A Randomized Double-Blinded Clinical Trial.,"BACKGROUND


Menaquinone-7 (MK-7), also known as vitamin K2, is a cofactor for the carboxylation of proteins involved in the inhibition of arterial calcification and has been suggested to reduce the progression rate of aortic valve calcification (AVC) in patients with aortic stenosis.
METHODS


In a randomized, double-blind, multicenter trial, men from the community with an AVC score >300 arbitrary units (AU) on cardiac noncontrast computer tomography were randomized to daily treatment with tablet 720 µg MK-7 plus 25 µg vitamin D or matching placebo for 24 months. The primary outcome was the change in AVC score. Selected secondary outcomes included change in aortic valve area and peak aortic jet velocity on echocardiography, heart valve surgery, change in aortic and coronary artery calcification, and change in dp-ucMGP (dephosphorylated-undercarboxylated matrix Gla-protein). Safety outcomes included all-cause death and cardiovascular events.
RESULTS


From February 1, 2018, to March 21, 2019, 365 men were randomized. Mean age was 71.0 (±4.4) years. The mean (95% CI) increase in AVC score was 275 AU (95% CI, 225-326 AU) and 292 AU (95% CI, 246-338 AU) in the intervention and placebo groups, respectively. The mean difference on AVC progression was 17 AU (95% CI, -86 to 53 AU;  P =0.64). The mean change in aortic valve area was 0.02 cm 2  (95% CI, -0.09 to 0.12 cm 2 ;  P =0.78) and in peak aortic jet velocity was 0.04 m/s (95% CI, -0.11 to 0.02 m/s;  P =0.21). The progression in aortic and coronary artery calcification score was not significantly different between patients treated with MK-7 plus vitamin D and patients receiving placebo. There was no difference in the rate of heart valve surgery (1 versus 2 patients;  P =0.99), all-cause death (1 versus 4 patients;  P =0.37), or cardiovascular events (10 versus 10 patients;  P =0.99). Compared with patients in the placebo arm, a significant reduction in dp-ucMGP was observed with MK-7 plus vitamin D (-212 pmol/L versus 45 pmol/L;  P <0.001).
CONCLUSIONS


In elderly men with an AVC score >300 AU, 2 years MK-7 plus vitamin D supplementation did not influence AVC progression.
REGISTRATION


URL: https://www.
CLINICALTRIALS


gov; Unique identifier: NCT03243890.",2022,The progression in aortic and coronary artery calcification score was not significantly different between patients treated with MK-7 plus vitamin D and patients receiving placebo.,"['Results:  From February 1, 2018, to March 21, 2019, 365 men were randomized', 'Patients With Aortic Valve Calcification', 'Mean age was 71.0 (±4.4) years', 'patients with aortic stenosis', 'elderly men with an AVC score >300 AU, 2 years', 'men from the community with an AVC score >300 arbitrary units (AU) on cardiac noncontrast computer tomography']","['MK-7 plus vitamin D supplementation', 'MK-7 plus vitamin D', 'tablet 720 μg MK-7 plus 25 μg vitamin D or matching placebo', 'Menaquinone-7 (MK-7', 'placebo', 'Vitamin K2 and D']","['AVC progression', 'AVC score', 'progression rate of aortic valve calcification (AVC', 'change in aortic valve area and peak aortic jet velocity on echocardiography, heart valve surgery, change in aortic and coronary artery calcification, and change in dp-ucMGP (dephosphorylated-undercarboxylated matrix Gla-protein', 'cause death and cardiovascular events', 'mean change in aortic valve area', 'rate of heart valve surgery', 'cardiovascular events', 'cause death', 'change in AVC score', 'progression in aortic and coronary artery calcification score', 'peak aortic jet velocity', 'dp-ucMGP']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428791', 'cui_str': 'Aortic valve calcification'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0718184', 'cui_str': 'AVC brand of sulfanilamide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439183', 'cui_str': 'Arbitrary unit'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078382', 'cui_str': 'vitamin MK 7'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}]","[{'cui': 'C0718184', 'cui_str': 'AVC brand of sulfanilamide'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428791', 'cui_str': 'Aortic valve calcification'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428817', 'cui_str': 'Aortic valve area'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0065752', 'cui_str': 'matrix Gla protein'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",365.0,0.728926,The progression in aortic and coronary artery calcification score was not significantly different between patients treated with MK-7 plus vitamin D and patients receiving placebo.,"[{'ForeName': 'Axel C P', 'Initials': 'ACP', 'LastName': 'Diederichsen', 'Affiliation': ""Department of Cardiology (A.C.P.D., K.A.Ø., M.H.F., S.H.' H.M., J.S.D.), Odense University Hospital, Denmark.""}, {'ForeName': 'Jes S', 'Initials': 'JS', 'LastName': 'Lindholt', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery (J.S.L.), Odense University Hospital, Denmark.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Open Patient Data Explorative Network (S.M.), Odense University Hospital, Denmark.'}, {'ForeName': 'Kristian A', 'Initials': 'KA', 'LastName': 'Øvrehus', 'Affiliation': ""Department of Cardiology (A.C.P.D., K.A.Ø., M.H.F., S.H.' H.M., J.S.D.), Odense University Hospital, Denmark.""}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Auscher', 'Affiliation': 'Department of Cardiology, Svendborg Hospital, Denmark (S.A., J.L.).'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Lambrechtsen', 'Affiliation': 'Department of Cardiology, Svendborg Hospital, Denmark (S.A., J.L.).'}, {'ForeName': 'Susanne E', 'Initials': 'SE', 'LastName': 'Hosbond', 'Affiliation': ""Department of Cardiology, Lillebaelt Hospital, Vejle, Denmark (S.E.H.' D.H.A.).""}, {'ForeName': 'Dilek H', 'Initials': 'DH', 'LastName': 'Alan', 'Affiliation': ""Department of Cardiology, Lillebaelt Hospital, Vejle, Denmark (S.E.H.' D.H.A.).""}, {'ForeName': 'Grazina', 'Initials': 'G', 'LastName': 'Urbonaviciene', 'Affiliation': 'Department of Cardiology, Regional Hospital Central Jutland, Silkeborg, Denmark (G.U., S.W.B.).'}, {'ForeName': 'Søren W', 'Initials': 'SW', 'LastName': 'Becker', 'Affiliation': 'Department of Cardiology, Regional Hospital Central Jutland, Silkeborg, Denmark (G.U., S.W.B.).'}, {'ForeName': 'Maise H', 'Initials': 'MH', 'LastName': 'Fredgart', 'Affiliation': ""Department of Cardiology (A.C.P.D., K.A.Ø., M.H.F., S.H.' H.M., J.S.D.), Odense University Hospital, Denmark.""}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Hasific', 'Affiliation': ""Department of Cardiology (A.C.P.D., K.A.Ø., M.H.F., S.H.' H.M., J.S.D.), Odense University Hospital, Denmark.""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Folkestad', 'Affiliation': 'Department of Endocrinology (L.F.), Odense University Hospital, Denmark.'}, {'ForeName': 'Oke', 'Initials': 'O', 'LastName': 'Gerke', 'Affiliation': 'Department of Nuclear Medicine (O.G.), Odense University Hospital, Denmark.'}, {'ForeName': 'Lars Melholt', 'Initials': 'LM', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Clinical Biochemistry and Pharmacology (L.M.R.), Odense University Hospital, Denmark.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Denmark (J.E.M.).'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Mickley', 'Affiliation': ""Department of Cardiology (A.C.P.D., K.A.Ø., M.H.F., S.H.' H.M., J.S.D.), Odense University Hospital, Denmark.""}, {'ForeName': 'Jordi S', 'Initials': 'JS', 'LastName': 'Dahl', 'Affiliation': ""Department of Cardiology (A.C.P.D., K.A.Ø., M.H.F., S.H.' H.M., J.S.D.), Odense University Hospital, Denmark.""}]",Circulation,['10.1161/CIRCULATIONAHA.121.057008']
892,35461239,Effects of a laughter program on body weight and mental health among Japanese people with metabolic syndrome risk factors: a randomized controlled trial.,"BACKGROUND


While there have been several intervention studies on the psychological effects of laughter, few have examined both the psychological and physical effects. This study investigates the effects of a laughter program on body weight, body mass index (BMI), subjective stress, depression, and health-related quality of life (HRQOL) among Japanese community-dwelling individuals using a randomized controlled trial with a waitlist.
METHODS


Overall, 235 participants (37 men and 198 women) aged 43-79 years (mean 66.9, median 67.0) were randomized into laughter intervention and control groups (n = 117 and n = 118, respectively) to participate in a 12-week laughter program. Body weight, subjective stress, subjective well-being, and HRQOL were measured at the baseline, with a 12-week follow-up. The laughter program intervention's effects on these factors were analyzed using an analysis of covariance adjusted by age, sex, risk factors, medication, and area. Furthermore, Pearson's correlation and a general linear model analyzed the relationship between participants' BMI and psychological index changes.
RESULTS


The comprehensive laughter program significantly improved the mean body weight (p = 0.008), BMI (p = 0.006), subjective stress (p = 0.004), subjective well-being (p = 0.002), optimism (p = 0.03), and physical component summary (PCS) scores of HRQOL (p = 0.04). A similar tendency occurred for the mean changes in BMI and subjective stress score by area, sex, and age. Moreover, there was a significant and negative correlation between the change in BMI and PCS change (p = 0.04).
CONCLUSION


The comprehensive 12-week laughter intervention program, mainly comprising laughter yoga, significantly improved physical and psychological functions such as body weight, BMI, subjective stress, subjective well-being, and HRQOL among predominantly elderly Japanese community-dwelling individuals with metabolic syndrome risk factors. Moreover, PCS improved among participants who reduced BMI after the intervention. These results suggest that the laughter program may help reduce body weight in participants with metabolic syndrome risk factors by reducing stress and improving HRQOL and mental health factors, such as subjective well-being and optimism.
TRIAL REGISTRATION


Registered with the University Hospital Medical Information Network Clinical Trials Registry UMIN-CTR000027145 on 27/04/2017.",2022,"The comprehensive laughter program significantly improved the mean body weight (p = 0.008), BMI (p = 0.006), subjective stress (p = 0.004), subjective well-being (p = 0.002), optimism (p = 0.03), and physical component summary (PCS) scores of HRQOL (p = 0.04).","['participants with metabolic syndrome risk factors', '235 participants (37 men and 198 women) aged 43-79\u2009years (mean 66.9, median 67.0', 'elderly Japanese community-dwelling individuals with metabolic syndrome risk factors', 'Japanese people with metabolic syndrome risk factors', 'Japanese community-dwelling individuals']","['laughter intervention', 'laughter program']","['Body weight, subjective stress, subjective well-being, and HRQOL', 'body weight and mental health', 'body weight', 'subjective stress', 'body weight, body mass index (BMI), subjective stress, depression, and health-related quality of life (HRQOL', 'BMI', 'physical component summary (PCS) scores of HRQOL', 'BMI and subjective stress score', 'BMI and PCS change', 'physical and psychological functions such as body weight, BMI, subjective stress, subjective well-being, and HRQOL', 'mean body weight']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0023133', 'cui_str': 'Laughing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",235.0,0.00939227,"The comprehensive laughter program significantly improved the mean body weight (p = 0.008), BMI (p = 0.006), subjective stress (p = 0.004), subjective well-being (p = 0.002), optimism (p = 0.03), and physical component summary (PCS) scores of HRQOL (p = 0.04).","[{'ForeName': 'Narumi', 'Initials': 'N', 'LastName': 'Funakubo', 'Affiliation': 'Department of Epidemiology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Eguchi', 'Affiliation': 'Department of Epidemiology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Hayashi', 'Affiliation': 'Public Health, Department of Social Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Hirosaki', 'Affiliation': 'Department of Epidemiology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Kokoro', 'Initials': 'K', 'LastName': 'Shirai', 'Affiliation': 'Public Health, Department of Social Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Okazaki', 'Affiliation': 'Department of Epidemiology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Nakano', 'Affiliation': 'Department of Epidemiology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Fumikazu', 'Initials': 'F', 'LastName': 'Hayashi', 'Affiliation': 'Department of Epidemiology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Omata', 'Affiliation': 'Department of Physical Therapy, Fukushima Medical University School of Health Sciences, Fukushima, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Imano', 'Affiliation': 'Public Health, Department of Social Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Iso', 'Affiliation': 'Public Health, Department of Social Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Ohira', 'Affiliation': 'Department of Epidemiology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 960-1295, Japan. teoohira@fmu.ac.jp.'}]",BMC geriatrics,['10.1186/s12877-022-03038-y']
893,35462880,"Complete nutrition drink with retrograded starch is low glycemic, and the individual glucose response to the low glycemic complete nutrition drink depends on fasting insulin levels and HOMA-IR in a randomized cross-over control trial.","Complete nutrition drinks with a low glycemic index (GI) provide nutritional support and prevent hyperglycaemia. The present study identified GI and factors predicting individual glucose response to a new complete nutrition drink. A randomised cross-over controlled trial was conducted in eighteen healthy volunteers (FPG < 100 mg/dl). Complete nutrition drinks containing retrograded starch, glucose solution and white bread were assigned in a random sequence with 14-day wash-out intervals. Plasma glucose and insulin levels were measured from baseline to 180 min after consuming each food. Results show the adjusted GIs of the drink was 48.2 ± 10.4 and 46.7 ± 12.7 with glucose and white bread as the reference, respectively. While the drink has low GI (<55), the individual glucose responses varied (GI: 7-149). Comparing characters in individual GI < 55 ( n =  12) and GI ≥ 55 ( n =  6) groups revealed significantly higher baseline insulin in the low GI group (14.86 ± 16.51 μIU/ml  v . 4.9 ± 3.4 μIU/ml,  P  < 0·05). The correlation matrix confirms only two predictive factors for having individual GI <55 were baseline insulin ( r  = 0·5,  P  = 0·03) and HOMA-IR ( r  = 0·55,  P  = 0·02). ROC curve reveals fasting insulin above 1.6 μIU/ml and HOMA-IR above 1.05 as the cut-off values. The findings suggest that the complete nutrition drink has a low GI, but there was wide variability in individual responses partly explained by fasting insulin levels and HOMA-IR. Screening for fasting insulin and HOMA-IR may be encouraged to maximise the functional benefit of the drink.",2022,ROC curve reveals fasting insulin above 1.6 μIU/ml and HOMA-IR above 1.05 as the cut-off values.,['eighteen healthy volunteers (FPG < 100 mg/dl'],"['Complete nutrition drinks with a low glycemic index (GI) provide nutritional support', 'Complete nutrition drinks containing retrograded starch, glucose solution and white bread', 'Complete nutrition drink with retrograded starch']","['individual glucose responses', 'HOMA-IR ( r', 'Plasma glucose and insulin levels']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0452550', 'cui_str': 'White bread'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",18.0,0.068466,ROC curve reveals fasting insulin above 1.6 μIU/ml and HOMA-IR above 1.05 as the cut-off values.,"[{'ForeName': 'Warisara', 'Initials': 'W', 'LastName': 'Wongniyomkaset', 'Affiliation': 'Master of Science Program in Nutrition and Dietetics, Institute of Nutrition, Mahidol University, Nakhon Pathom 73170, Thailand.'}, {'ForeName': 'Numphung', 'Initials': 'N', 'LastName': 'Rungraung', 'Affiliation': 'Institute of Nutrition, Mahidol University, Nakhon Pathom 73170, Thailand.'}, {'ForeName': 'Niramol', 'Initials': 'N', 'LastName': 'Muangpracha', 'Affiliation': 'Institute of Nutrition, Mahidol University, Nakhon Pathom 73170, Thailand.'}, {'ForeName': 'Thunnalin', 'Initials': 'T', 'LastName': 'Winuprasith', 'Affiliation': 'Institute of Nutrition, Mahidol University, Nakhon Pathom 73170, Thailand.'}, {'ForeName': 'Dunyaporn', 'Initials': 'D', 'LastName': 'Trachootham', 'Affiliation': 'Institute of Nutrition, Mahidol University, Nakhon Pathom 73170, Thailand.'}]",Journal of nutritional science,['10.1017/jns.2022.23']
894,35466013,SCOPE 2 - Still Answering the Unanswered Questions in Oesophageal Radiotherapy? SCOPE 2: a Randomised Phase II/III Trial to Study Radiotherapy Dose Escalation in Patients with Oesophageal Cancer Treated with Definitive Chemoradiation with an Embedded Phase II Trial for Patients with a Poor Early Response using Positron Emission Tomography/Computed Tomography.,"The SCOPE 2 trial of definitive chemoradiotherapy in oesophageal cancer investigates the benefits of radiotherapy dose escalation and systemic therapy optimisation. The trial opened in 2016. The landscape of oesophageal cancer treatment over the lifetime of this trial has changed significantly and the protocol has evolved to reflect this. However, with the recent results of the Dutch phase III ART DECO study showing no improvement in local control or overall survival with radiotherapy dose escalation in a similar patient group, we sought to determine if the SCOPE 2 trial is still answering the key unanswered questions for oesophageal radiotherapy. Here we discuss the rationale behind the SCOPE 2 trial, outline the trial schema and review current data on dose escalation and outline recommendations for future areas of research.",2022,The SCOPE 2 trial of definitive chemoradiotherapy in oesophageal cancer investigates the benefits of radiotherapy dose escalation and systemic therapy optimisation.,['Patients with Oesophageal Cancer Treated with Definitive Chemoradiation with an Embedded Phase II Trial for Patients with a Poor Early Response using Positron Emission Tomography/Computed Tomography'],"['definitive chemoradiotherapy', 'radiotherapy', 'Radiotherapy Dose Escalation']",['local control or overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0958592,The SCOPE 2 trial of definitive chemoradiotherapy in oesophageal cancer investigates the benefits of radiotherapy dose escalation and systemic therapy optimisation.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bridges', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thomas', 'Affiliation': 'Velindre University NHS Trust, Cardiff, UK. Electronic address: betsan.thomas@wales.nhs.uk.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Radhakrishna', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hawkins', 'Affiliation': 'University College London, Medical Physics and Biomedical Engineering, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Holborow', 'Affiliation': 'South West Wales Cancer Centre, Swansea, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hurt', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Oxford Institute for Radiation Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nixon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Crosby', 'Affiliation': 'Velindre University NHS Trust, Cardiff, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gwynne', 'Affiliation': 'South West Wales Cancer Centre, Swansea, UK; Swansea University Medical School, Swansea, UK.'}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2022.03.019']
895,35467254,"Correction to: Clinical Trials-Related Knowledge, Attitudes, and Behaviors Among Black and Latina Women: A Randomized Controlled Trial of the Women United: Clinical Trials and the Fight Against Breast Cancer Program.",,2022,,['Black and Latina Women'],[],[],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.304877,,"[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Merz', 'Affiliation': 'Department of Psychology, California State University, Dominguez Hills, 1000 E. Victoria Street, Carson, CA, 90747, USA. emerz@csudh.edu.'}, {'ForeName': 'Natasha E', 'Initials': 'NE', 'LastName': 'Riley', 'Affiliation': 'Vista Community Clinic, Vista, USA.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Malcarne', 'Affiliation': 'SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, USA.'}, {'ForeName': 'Georgia Robins', 'Initials': 'GR', 'LastName': 'Sadler', 'Affiliation': 'SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-022-02174-8']
896,34872341,Clinical and Imaging Indicators of Hemorrhagic Transformation in Acute Ischemic Stroke After Endovascular Thrombectomy.,"BACKGROUND


Prior studies have investigated the clinical and imaging factors for hemorrhagic transformation (HT), especially symptomatic intracranial hemorrhage (sICH); however, whether alteplase increases the risk of HT after endovascular thrombectomy (EVT) is unknown. This study aimed to assess clinical and imaging features associated with HT, sICH, and parenchymal hematoma (PH) in patients with acute ischemic stroke after EVT, with and without intravenous alteplase in DIRECT-MT (Direct Intraarterial Thrombectomy to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals: a Multicenter Randomized Clinical Trial).
METHODS


The DIRECT-MT trial is a randomized trial of EVT alone versus intravenous thrombolysis combined with EVT. HT, sICH, and PH was evaluated on follow-up computed tomography. Multivariable ordinal logistic regression analysis was used to test the association of stepwise selected determinants with HT, sICH, and PH.
RESULTS


In total, 633 patients were analyzed; 261 (41.2%) had HT; 34 (5.4%) had sICH; and 85 (13.4%) had PH. The median age was 69, and 56.7% were men. The median National Institutes of Health Stroke Scale score was 18, and 320 patients were in combination-therapy group. Symptomatic intracranial hemorrhage was associated with higher baseline National Institutes of Health Stroke Scale score (adjusted odds ratio [OR], 1.06 [95% CI, 1.10-1.12]) and higher glucose level at hospital arrival (adjusted OR, 1.14 [95% CI, 1.00-1.29]). No association was found between alteplase treatment and HT, sICH, or PH. The independent predictor of sICH was higher baseline National Institutes of Health Stroke Scale score (adjusted OR, 1.09 [95% CI, 1.01-1.18]) in EVT alone group, and history of anticoagulant drugs (adjusted OR, 3.75 [95% CI, 1.07-13.06]), higher glucose level at hospital arrival (adjusted OR, 1.19 [95% CI, 1.03-1.38]), >3 passes of device (adjusted OR, 4.42 [95% CI, 1.36-14.32]) in combination-therapy group.
CONCLUSIONS


In DIRECT-MT, independent predictors of sICH were baseline National Institutes of Health Stroke Scale score and glucose level at hospital arrival. Alteplase treatment did not increase the risk of HT, sICH, or PH after EVT. The independent predictor of sICH was different in EVT alone group and combination-therapy group.
REGISTRATION


URL: https://www.
CLINICALTRIALS


gov; Unique identifier: NCT03469206.",2022,"Alteplase treatment did not increase the risk of HT, sICH, or PH after EVT.","['Acute Ischemic Stroke', 'The median age was 69, and 56.7% were men', '633 patients were analyzed; 261 (41.2%) had HT; 34 (5.4%) had sICH; and 85 (13.4%) had PH', 'patients with acute ischemic stroke after EVT, with and without intravenous alteplase in DIRECT-MT (Direct Intraarterial Thrombectomy to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals']","['EVT alone versus intravenous thrombolysis combined with EVT', 'HT, sICH, and parenchymal hematoma (PH', 'PH']","['Symptomatic intracranial hemorrhage', 'Health Stroke Scale score', 'glucose level at hospital arrival', 'higher glucose level at hospital arrival', 'risk of HT, sICH, or PH after EVT', 'HT, sICH, and PH', 'median National Institutes of Health Stroke Scale score']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0694634', 'cui_str': 'Intra-arterial'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]",633.0,0.23706,"Alteplase treatment did not increase the risk of HT, sICH, or PH after EVT.","[{'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Tian', 'Affiliation': 'Department of Radiology (B.T., X.T., Z.S., W.P., Xuefeng Zhang, J. Lu), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Radiology (B.T., X.T., Z.S., W.P., Xuefeng Zhang, J. Lu), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Radiology (B.T., X.T., Z.S., W.P., Xuefeng Zhang, J. Lu), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Department of Radiology (B.T., X.T., Z.S., W.P., Xuefeng Zhang, J. Lu), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology (B.T., X.T., Z.S., W.P., Xuefeng Zhang, J. Lu), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Neurovascular Center (P.Y., Z.L., Xiaoxi Zhang, J. Liu), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Zifu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Neurovascular Center (P.Y., Z.L., Xiaoxi Zhang, J. Liu), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Neurovascular Center (P.Y., Z.L., Xiaoxi Zhang, J. Liu), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lou', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Zhejiang University, China (M.L.).'}, {'ForeName': 'Congguo', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Hangzhou First People's Hospital of Zhejiang University, China (C.Y.).""}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neurovascular Center (Y.Z.), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology (B.T., X.T., Z.S., W.P., Xuefeng Zhang, J. Lu), Changhai hospital of Shanghai, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.035425']
897,35469409,"Effects of everolimus plus minimized tacrolimus on kidney function in liver transplantation: REDUCE, a prospective, randomized controlled study.","BACKGROUND AND AIM


reduction in calcineurin inhibitor levels is considered crucial to decrease the incidence of kidney dysfunction in liver transplant (LT) recipients. The aim of this study was to evaluate the safety and impact of everolimus plus reduced tacrolimus (EVR + rTAC) vs. mycophenolate mofetil plus tacrolimus (MMF + TAC) on kidney function in LT recipients from Spain.
METHODS


the REDUCE study was a 52-week, multicenter, randomized, controlled, open-label, phase 3b study in de novo LT recipients. Eligible patients were randomized (1:1) 28 days post-transplantation to receive EVR + rTAC (TAC levels ≤ 5 ng/mL) or to continue with MMF + TAC (TAC levels = 6-10 ng/mL). Mean estimated glomerular filtration rate (eGFR), clinical benefit in renal function, and safety were evaluated.
RESULTS


in the EVR + rTAC group (n = 105), eGFR increased from randomization to week 52 (82.2 [28.5] mL/min/1.73 m2 to 86.1 [27.9] mL/min/1.73 m2) whereas it decreased in the MMF + TAC (n = 106) group (88.4 [34.3] mL/min/1.73 m2 to 83.2 [25.2] mL/min/1.73 m2), with significant (p < 0.05) differences in eGFR throughout the study. However, both groups had a similar clinical benefit regarding renal function (improvement in 18.6 % vs. 19.1 %, and stabilization in 81.4 % vs. 80.9 % of patients in the EVR + rTAC vs. MMF + TAC groups, respectively). There were no significant differences in the incidence of acute rejection (5.7 % vs. 3.8 %), deaths (5.7 % vs. 2.8 %), and serious adverse events (51.9 % vs. 44.0 %) between the 2 groups.
CONCLUSION


EVR + rTAC allows a safe reduction in tacrolimus exposure in de novo liver transplant recipients, with a significant improvement in eGFR but without significant differences in renal clinical benefit 1 year after liver transplantation.",2022,"There were no significant differences in the incidence of acute rejection (5.7% vs 3.8%), deaths (5.7% vs 2.8%), and serious adverse events (51.9% vs 44.0%) between the 2 groups.
","['Eligible patients', 'm2', 'de novo LT recipients', 'liver transplant (LT) recipients', 'liver transplantation', 'LT recipients from Spain']","['Everolimus plus minimized tacrolimus', 'MMF+TAC', 'EVR+rTAC (TAC levels ≤\u202f5 ng/mL) or to continue with MMF+TAC', 'everolimus plus reduced tacrolimus (EVR+rTAC) vs mycophenolate mofetil plus tacrolimus (MMF+TAC', 'EVR+rTAC']","['kidney function', 'renal function', 'incidence of acute rejection', 'eGFR changes', 'deaths', 'serious adverse events', 'eGFR', 'Mean estimated glomerular filtration rate (eGFR), clinical benefit in renal function, and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0250811,"There were no significant differences in the incidence of acute rejection (5.7% vs 3.8%), deaths (5.7% vs 2.8%), and serious adverse events (51.9% vs 44.0%) between the 2 groups.
","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gómez-Bravo', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Spain.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Prieto Castillo', 'Affiliation': 'Medicina Digestiva, Hospital Universitari i Politècnic La Fe, España.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Navasa', 'Affiliation': 'Liver Transplant Unit, Hospital Clínic. Universidad de Barcelona, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Sánchez-Antolín', 'Affiliation': 'Hospital Universitario Río Hortega, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lladó', 'Affiliation': ""Hospital Universitari de Bellvitge. Institut d'Investigació Biomèdica de Bellvitge, Spain.""}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Otero', 'Affiliation': 'Hospital Universitario de A Coruña, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Serrano', 'Affiliation': 'Hospital Clínico Universitario Lozano Blesa.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Jiménez Romero', 'Affiliation': 'Cirugía General, Hospital Universitario 12 de Octubre, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'García González', 'Affiliation': 'Gastroenterología y Hepatología, Hospital Universitario Ramón y Cajal, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Valdivieso', 'Affiliation': 'Unidad de Cirugía Hepática y Trasplante Hepático, Hospital Universitario Cruces, Spain.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'González-Diéguez', 'Affiliation': 'Gastroenterology and Hepatology, Hospital Universitario Central de Asturias, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'de la Mata', 'Affiliation': 'Sección de Hepatología y Trasplante Hepático, Hospital Universitario Reina Sofía, España.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Pons', 'Affiliation': 'Aparato Digestivo, Hospital Clínico Universitario Virgen de la Arrixaca, España.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Salcedo', 'Affiliation': 'Aparato Digestivo, Hospital General Universitario Gregorio Marañón, Spain.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Rodrigo', 'Affiliation': 'Hospital Regional Universitario de Málaga, Spain.'}, {'ForeName': 'Valentín', 'Initials': 'V', 'LastName': 'Cuervas-Mons', 'Affiliation': 'Medicina Interna, Hospital Universitario Puerta de Hierro Majadahonda.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'González Rodríguez', 'Affiliation': 'Aparato Digestivo y Gastroenterología, Hospital Universitario Nuestra Señora de Candelaria, España.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Caralt', 'Affiliation': 'Hospital Universitari Vall d´Hebron. Universidad Autónoma de Barcelona, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pardo', 'Affiliation': 'General Surgery, Clínica Universidad de Navarra, España.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Varo Pérez', 'Affiliation': 'Unidad de Trasplante Abdominal - Cirugía General, Hospital Universitario de Santiago.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Crespo', 'Affiliation': 'Liver Transplant Unit, Hospital Clínic de Barcelona. Universidad de Barcelona, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Rubin', 'Affiliation': 'Hospital Universitari i Politècnic La Fe-IIS La Fe, Spain.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Guilera', 'Affiliation': 'Novartis Farmacéutica S.A., Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Aldea', 'Affiliation': 'Novartis Farmacéutica S.A., Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Santoyo', 'Affiliation': 'Hospital Regional Universitario de Málaga.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2022.8549/2021']
898,35470105,The short-term effect of high dose vitamin D3 supplementation in improving hypovitaminosis in patients with type 2 diabetes - A randomized clinical trial.,"BACKGROUND


Type 2 diabetes (T2D) is an epidemic public health concern with considerable morbidity and mortality. Previous research has shown the association between T2D and vitamin D deficiency. This vitamin significantly affects insulin function, which plays a critical role in T2D development.
AIMS


A prospective double-blinded randomized controlled trial was conducted to test the hypothesis that vitamin D3 (VD3) supplementation can correct VD deficiency without the risk of hypervitaminosis.
METHODS


The participants of this study included 62 patients with T2D and hypovitaminosis D3. Of these patients, 30 received cholecalciferol (50,000 IU weekly for 8 weeks), and 32 received identical placebo tablets for 8 weeks. Before and after the intervention, patients were subjected to VD3 level assessment through fasting blood samples.
RESULTS


After 8 weeks of intervention, the mean changes in serum VD3 levels in the VD3 group were significant compared to the placebo group (i.e., 21.9 ± 10 vs. 1.2 ± 7 ng/ml, P < 0.001). Also, comparing serum D3 levels of the endpoint with the baseline revealed statistically significant changes in the VD3 group (40 ± 10 vs. 18.1 ± 6 ng/ml, P < 0.001) but no significant change in the placebo group (18.9 ± 7 vs. 20.1 ± 7, P = 0.37).
CONCLUSION


The results showed that administering a weekly dose of VD3 supplement could improve serum levels above 30 ng/ml in patients with T2D and compensate for vitamin deficiency without the risk of hypervitaminosis, which occurs at the levels above 100 ng/ml of 25(OH)D. However, further large-scale studies are needed to determine if these findings are applicable.",2022,"After 8 weeks of intervention, the mean changes in serum VD3 levels in the VD3 group were significant compared to the placebo group (i.e., 21.9 ± 10 vs. 1.2 ± 7 ng/ml, P < 0.001).","['62 patients with T2D and hypovitaminosis D3', 'patients with type 2 diabetes']","['cholecalciferol', 'VD3 supplement', 'placebo tablets', 'vitamin D3 supplementation', 'placebo', 'vitamin D3 (VD3) supplementation']","['mean changes in serum VD3 levels', 'serum D3 levels', 'serum levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0376286', 'cui_str': 'Avitaminosis'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",62.0,0.814422,"After 8 weeks of intervention, the mean changes in serum VD3 levels in the VD3 group were significant compared to the placebo group (i.e., 21.9 ± 10 vs. 1.2 ± 7 ng/ml, P < 0.001).","[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Behshad', 'Affiliation': 'Department of Clinical Biochemistry, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Sameep S', 'Initials': 'SS', 'LastName': 'Shetty', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences Mangalore,India. Manipal Academy of higher education, A constituent of MAHE,Manipal.'}, {'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Riahi', 'Affiliation': 'Cardiovascular Diseases Research Center, Department of Epidemiology and Biostatistics, School of Medicine, Birjand University of Medical Sciences, Birjand, Iran. Electronic address: Riahim61@gmail.com.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106769']
899,35470260,"Treatment gaps, 1-year readmission and mortality following myocardial infarction by diabetes status, sex and socioeconomic disadvantage.","AIMS


We evaluated variation in treatment for, and outcomes following, myocardial infarction (MI) by diabetes status, sex and socioeconomic disadvantage.
METHODS


We included all people aged ≥30 years who were discharged alive from hospital following MI between 1 July 2012 and 30 June 2017 in Victoria, Australia (n=43 272). We assessed receipt of inpatient procedures and discharge dispensing of cardioprotective medications for each admission, as well as 1-year all-cause, cardiovascular, and MI readmission rates and 1-year all-cause mortality.
RESULTS


Risk of all-cause (HR: 1.22 (1.19-1.26)), cardiovascular (1.29 (1.25-1.34)), MI (1.52 (1.43-1.62)) and heart failure readmission (1.62 (1.50-1.75)) and mortality (1.18 (1.11-1.26)) were higher in people with diabetes. Males and people in more disadvantaged areas were at increased risk of readmission and mortality following MI. People with diabetes (vs without) were more likely to receive coronary artery bypass grafting (CABG) but less likely to receive percutaneous coronary intervention (PCI) during, or within 30 days of, their index admission. Females were less likely to receive either (eg, 87% of males with a STEMI received PCI or CABG vs 70% of females), and people in more disadvantaged areas were less likely to receive PCI. People with diabetes, males and people in more disadvantaged areas were more likely to be dispensed cardioprotective medications at or within 90 days of discharge.
CONCLUSIONS


Following an MI, people with diabetes and males had poorer outcomes but received more intensive cardiovascular treatments. However, socioeconomic disadvantage was associated with both less intensive inpatient treatment and poorer outcomes.",2022,"People with diabetes, males and people in more disadvantaged areas were more likely to be dispensed cardioprotective medications at or within 90 days of discharge.
","['People with diabetes (vs without', 'People with diabetes, males and people in more disadvantaged areas', 'all people aged ≥30 years who were discharged alive from hospital following MI between 1 July 2012 and 30 June 2017 in Victoria, Australia (n=43 272']","['coronary artery bypass grafting (CABG', 'percutaneous coronary intervention (PCI']","['cardiovascular', '1-year readmission and mortality following myocardial infarction by diabetes status, sex and socioeconomic disadvantage', 'mortality', '1-year all-cause, cardiovascular, and MI readmission rates and 1-year all-cause mortality', 'MI', 'heart failure readmission', 'risk of readmission and mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.114988,"People with diabetes, males and people in more disadvantaged areas were more likely to be dispensed cardioprotective medications at or within 90 days of discharge.
","[{'ForeName': 'Jedidiah I', 'Initials': 'JI', 'LastName': 'Morton', 'Affiliation': 'Diabetes and Population Health, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia jedidiah.morton@baker.edu.au.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Ilomäki', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Wood', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'J Simon', 'Initials': 'JS', 'LastName': 'Bell', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Huynh', 'Affiliation': 'Diabetes and Population Health, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dianna J', 'Initials': 'DJ', 'LastName': 'Magliano', 'Affiliation': 'Diabetes and Population Health, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Diabetes and Population Health, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}]",Journal of epidemiology and community health,['10.1136/jech-2021-218042']
900,35471257,Sensory enhancement of warm-up amplifies subsequent grip strength and cycling performance.,"PURPOSE


In sport and exercise, warm-ups induce various physiological changes that facilitate subsequent performance. We have shown that delivering patterned stimulation to cutaneous afferents during sprint cycling mitigates fatigue-related decrements in performance, and that repeated sensory stimulation amplifies spinal reflex excitability. Therefore, the purpose of this study was to assess whether sensory enhancement of warm-up would affect subsequent high-intensity arm cycling performance.
METHODS


Participants completed three experimental sessions, in which they randomly performed either a control, stim, or sleeve warm-up condition prior to maximal duration arm cycling. During the control condition, warmup consisted of low-intensity arm cycling for 15 min. The stim condition was the same, except they received alternating pulses (400 ms, 50 Hz) of stimulation just above their perceptual threshold to the wrists during warm-up. The third condition required participants to wear custom fabricated compression sleeves around the elbow during warm-up. Grip strength and spinal reflex excitability were measured before and after each warm-up and fatigue protocol, which required participants to arm cycle at 85% of peak power output until they reached volitional fatigue. Peak power output was determined during an incremental test at minimum 72 h prior to the first session.
RESULTS


Both sensory enhanced warm-up conditions amplified subsequent high-intensity arm cycling performance by ~ 30%. Additionally, the stim and sleeve warm-up conditions yielded improvements in grip strength (increased by ~ 5%) immediately after the sensory enhanced warm-ups. Ergogenic benefits from the sensory enhanced warm-up conditions did not differ between one another.
CONCLUSION


These findings demonstrate that enhanced sensory input during warm-up can elicit improvements in both maximal and submaximal performance measures.",2022,"Ergogenic benefits from the sensory enhanced warm-up conditions did not differ between one another.
",[],"['control, stim, or sleeve warm-up condition prior to maximal duration arm cycling', 'alternating pulses (400\xa0ms, 50\xa0Hz) of stimulation just above their perceptual threshold to the wrists during warm-up']","['grip strength', 'grip strength and cycling performance', 'Peak power output', 'Grip strength and spinal reflex excitability']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",,0.0336719,"Ergogenic benefits from the sensory enhanced warm-up conditions did not differ between one another.
","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Nazaroff', 'Affiliation': 'Rehabilitation Neuroscience Laboratory, University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Gregory E P', 'Initials': 'GEP', 'LastName': 'Pearcey', 'Affiliation': 'Rehabilitation Neuroscience Laboratory, University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Munro', 'Affiliation': 'Nike Sports Research Laboratory, NIKE Inc., Beaverton, OR, USA.'}, {'ForeName': 'E Paul', 'Initials': 'EP', 'LastName': 'Zehr', 'Affiliation': 'Rehabilitation Neuroscience Laboratory, University of Victoria, Victoria, BC, Canada. pzehr@uvic.ca.'}]",European journal of applied physiology,['10.1007/s00421-022-04952-0']
901,35471254,Deep learning signatures reveal multiscale intratumor heterogeneity associated with biological functions and survival in recurrent nasopharyngeal carcinoma.,"PURPOSE


How to discriminate different risks of recurrent nasopharyngeal carcinoma (rNPC) patients and guide individual treatment has become of great importance. This study aimed to explore the associations between deep learning signatures and biological functions as well as survival in (rNPC) patients.
METHODS


A total of 420 rNPC patients with PET/CT imaging and follow-up of overall survival (OS) were retrospectively enrolled. All patients were randomly divided into a training set (n = 269) and test set (n = 151) with a 6:4 ratio. We constructed multi-modality deep learning signatures from PET and CT images with a light-weighted deep convolutional neural network EfficienetNet-lite0 and survival loss DeepSurvLoss. An integrated nomogram was constructed incorporating clinical factors and deep learning signatures from PET/CT. Clinical nomogram and single-modality deep learning nomograms were also built for comparison. Furthermore, the association between biological functions and survival risks generated from an integrated nomogram was analyzed by RNA sequencing (RNA-seq).
RESULTS


The C-index of the integrated nomogram incorporating age, rT-stage, and deep learning PET/CT signature was 0.741 (95% CI: 0.688-0.794) in the training set and 0.732 (95% CI: 0.679-0.785) in the test set. The nomogram stratified patients into two groups with high risk and low risk in both the training set and test set with hazard ratios (HR) of 4.56 (95% CI: 2.80-7.42, p < 0.001) and 4.05 (95% CI: 2.21-7.43, p < 0.001), respectively. The C-index of the integrated nomogram was significantly higher than the clinical nomogram and single-modality nomograms. When stratified by sex, N-stage, or EBV DNA, risk prediction of our integrated nomogram was valid in all patient subgroups. Further subgroup analysis showed that patients with a low-risk could benefit from surgery and re-irradiation, while there was no difference in survival rates between patients treated by chemotherapy in the high-risk and low-risk groups. RNA sequencing (RNA-seq) of data further explored the mechanism of high- and low-risk patients from the genetic and molecular level.
CONCLUSION


Our study demonstrated that PET/CT-based deep learning signatures showed satisfactory prognostic predictive performance in rNPC patients. The nomogram incorporating deep learning signatures successfully divided patients into different risks and had great potential to guide individual treatment: patients with a low-risk were supposed to be treated with surgery and re-irradiation, while for high-risk patients, the application of palliative chemotherapy may be sufficient.",2022,The C-index of the integrated nomogram was significantly higher than the clinical nomogram and single-modality nomograms.,"['rNPC) patients', 'rNPC patients', 'divided patients into different risks and had great potential to guide individual treatment: patients with a low-risk', 'recurrent nasopharyngeal carcinoma', 'recurrent nasopharyngeal carcinoma (rNPC) patients', '420 rNPC patients with PET/CT imaging and follow-up of overall survival (OS) were retrospectively enrolled']",['PET/CT'],"['biological functions and survival risks', 'survival rates', 'satisfactory prognostic predictive performance']","[{'cui': 'C0278952', 'cui_str': 'Nasopharyngeal cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]","[{'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]","[{'cui': 'C3714634', 'cui_str': 'Biological Process'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]",420.0,0.0918086,The C-index of the integrated nomogram was significantly higher than the clinical nomogram and single-modality nomograms.,"[{'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""School of Artificial Intelligence, University of Chinese Academy of Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Yu-Jing', 'Initials': 'YJ', 'LastName': 'Liang', 'Affiliation': ""Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Dong-Xiang', 'Initials': 'DX', 'LastName': 'Wen', 'Affiliation': ""Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': ""Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, People's Republic of China.""}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': ""Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, 510060, People's Republic of China. tanglq@sysucc.org.cn.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': ""School of Artificial Intelligence, University of Chinese Academy of Sciences, Beijing, People's Republic of China. di.dong@ia.ac.cn.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""School of Artificial Intelligence, University of Chinese Academy of Sciences, Beijing, People's Republic of China. jie.tian@ia.ac.cn.""}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': ""Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, 510060, People's Republic of China. maihq@sysucc.org.cn.""}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-022-05793-x']
902,35474459,"Response: A randomized, double-blind, placebo-controlled pilot study of the comparative effects of dienogest and the combined oral contraceptive pill in women with endometriosis.",,2022,,['women with endometriosis'],"['placebo', 'dienogest and the combined oral contraceptive pill']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]",[],,0.383833,,"[{'ForeName': 'Gelareh', 'Initials': 'G', 'LastName': 'Niakan', 'Affiliation': 'School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ebrahimpour', 'Affiliation': 'Department of Psychology, Qaenat Branch, Islamic Azad University, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hassanlouei', 'Affiliation': 'Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.14202']
903,35474448,Interrupted subcuticular suture spacing during linear wound closures and the effect on wound cosmesis: a randomized evaluator-blinded split-wound comparative effectiveness trial.,"BACKGROUND


Surgical reconstructions following Mohs micrographic surgery and standard surgical excisions are often closed with two layers of sutures: a deep subcuticular layer and a superficial cuticular layer. Some surgeons feel the need to place many deep sutures in order to reduce tension on cuticular sutures, as they believe this may decrease incidence of track marks and dehiscence, and lead to better cosmetic outcomes. However, others feel that a higher number of subcuticular sutures increases the risk of a suture reaction, which leads to patient anxiety and poorer wound cosmesis. To our knowledge, there are no studies published on the effect of subcuticular suture spacing on wound cosmesis.
OBJECTIVES


To determine whether suturing with 1-cm interval subcuticular sutures results in better cosmetic outcomes than suturing with 2-cm interval subcuticular sutures.
METHODS


Fifty patients were enrolled in a randomized clinical trial using a split-wound model, where half of the wound was repaired with sutures spaced 2 cm apart and the other half was repaired with sutures spaced 1 cm apart (ClinicalTrials.gov identifier NCT03327922). Both the evaluators and patients were blinded as to which side received which treatment. The scar was evaluated 3 months post-surgery by two blinded observers and the patients themselves using the Patient and Observer Scar Assessment Scale (POSAS), a validated scar assessment instrument.
RESULTS


The total mean POSAS score for observers for the sides that received 1-cm interval subcuticular sutures and the sides that received 2-cm interval subcuticular sutures did not differ significantly at 3 months (P = 0·34). There was also no significant difference in the patient assessment scale score between the two sides at 3 months (P = 0·084).
CONCLUSIONS


We found that 1-cm suture spacing was not significantly associated with improved overall cosmetic outcome compared with 2-cm suture spacing when evaluated by blinded observers or the patients themselves. Our results support the use of either interval. What is already known about this topic? Surgeons have differing opinions on the ideal frequency of subcuticular sutures for optimizing cosmetic outcomes and minimizing suture reactions. The effect of subcuticular suture spacing on wound cosmesis has not been previously explored in the literature. What does this study add? There was no significant difference in cosmetic outcome between 1-cm suture spacing and 2-cm suture spacing when evaluated by blinded observers and patients. Dermatology surgeons can use 2-cm suture spacing for increased efficiency, without significantly different cosmetic outcomes, detected by blinded observers and patients.",2022,We found that 1 cm suture spacing was not significantly associated with improved overall cosmetic outcome compared with 2 cm suture spacing when evaluated by blinded observers or the patients themselves.,['50 patients'],"['suturing with 1 cm interval subcuticular sutures', 'suturing with 2 cm interval subcuticular sutures', 'Interrupted Subcuticular Suture Spacing', 'micrographic surgery and standard surgical excisions', 'subcuticular suture spacing']","['patient anxiety and poorer wound cosmesis', 'cosmetic outcomes', 'patient assessment scale score', 'overall cosmetic outcome', 'Wound Cosmesis', 'Patient and Observer Scar Assessment Scale (POSAS), a validated scar assessment instrument', 'total mean POSAS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0728940', 'cui_str': 'Excision'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",50.0,0.119473,We found that 1 cm suture spacing was not significantly associated with improved overall cosmetic outcome compared with 2 cm suture spacing when evaluated by blinded observers or the patients themselves.,"[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Eshagh', 'Affiliation': 'Department of Dermatology, University of California, Los Angeles, UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Sklar', 'Affiliation': 'Department of Dermatology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Aunna', 'Initials': 'A', 'LastName': 'Pourang', 'Affiliation': 'Department of Dermatology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, Keck School of Medicine of the University of Southern California, Sacramento, CA, USA.'}, {'ForeName': 'Harshaan', 'Initials': 'H', 'LastName': 'Dhaliwal', 'Affiliation': 'Creighton University School of Medicine, Omaha, NE, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Eisen', 'Affiliation': 'Department of Dermatology, UC Davis, Davis, CA, USA.'}]",The British journal of dermatology,['10.1111/bjd.21625']
904,35500422,Is an epidural component during general anaesthesia for caesarean section beneficial for neonatal puppies' health and vitality?,"Regional centro-axial block is a recommended technique for uncomplicated caesarean section in human medicine. Since the application of regional anaesthesia as the only technique in veterinary medicine is impractical, the objective of the study was to assess and compare the epidural component of caesarean section (CS) on maternal and fetal outcomes. Bitches (n = 36) undergoing elective CS were enrolled in this study. Females were randomly assigned into two groups: Gr I (Isoflurane, n = 20) and Gr IE (Isoflurane plus Epidural, n = 16). Anaesthesia was induced with propofol, and maintained with isoflurane in oxygen. In the IE group, epidural anaesthesia was also performed using lidocaine. The maternal intraoperative parameters were compared at three time points: T1 - just before the skin incision, T2 - after the last puppy removal, and T3 - at the end of surgery. At least 100 mcl of mixed umbilical cord blood was collected for gas analysis. The modified Apgar scoring system (AS) was used to objectively score newborn health and vitality immediately after birth (0 min), 5 and 20 min after birth. Systolic, diastolic, and mean blood pressure were lower in the IE group at T1, T2, and T3 compared to I group (p < 0.05). In the combined anaesthesia group blood pressure remained stable but low at all time points. Throughout surgery, the IE group required a lower concentration of isoflurane (p < 0.05). The median values of the umbilical blood gas results were found to be similar (p > 0.05) in both investigated groups. The initial results of the Apgar score were comparable in the I and IE groups (p > 0.05). However, subsequent AS measurements revealed significant differences between both groups. Puppies from the IE group received better AS scores at 5 and 20 min compared to the I group (median AS 8 and 9 vs. 5 and 8, respectively). The results obtained demonstrated that epidural anaesthesia administration reduced the requirement for isoflurane in dams undergoing caesarean section and despite episodes of maternal hypotension did not affect the results of neonatal umbilical blood gas. Furthermore, newborns from the epidural anaesthesia group improved more quickly postnatally, developing a satisfactory condition in a shorter time.",2022,The initial results of the Apgar score were comparable in the I and IE groups (p > 0.05).,"['Bitches (n\xa0=\xa036) undergoing elective CS', 'uncomplicated caesarean section in human medicine']","['isoflurane', 'propofol', 'Gr I (Isoflurane, n\xa0=\xa020) and Gr IE (Isoflurane plus Epidural', 'lidocaine', 'epidural anaesthesia']","['maternal hypotension', 'median values of the umbilical blood gas results', 'Systolic, diastolic, and mean blood pressure', 'blood pressure', 'neonatal umbilical blood gas', 'Apgar score', 'lower concentration of isoflurane']","[{'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}]",36.0,0.0248733,The initial results of the Apgar score were comparable in the I and IE groups (p > 0.05).,"[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Antończyk', 'Affiliation': 'Wroclaw University of Environmental and Life Sciences, Faculty of Veterinary Medicine, Department and Clinic of Surgery, pl. Grunwaldzki 51, 50-366, Wrocław, Poland. Electronic address: agnieszka.antonczyk@upwr.edu.pl.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Ochota', 'Affiliation': 'Wroclaw University of Environmental and Life Sciences, Faculty of Veterinary Medicine, Department of Reproduction and Clinic of Farm Animals, pl. Grunwaldzki 49, 50-366, Wrocław, Poland. Electronic address: malgorzata.ochota@upwr.edu.pl.'}]",Theriogenology,['10.1016/j.theriogenology.2022.04.015']
905,35472588,General anaesthesia with double-lumen intubation compared to opioid-sparing strategies with laryngeal mask for thoracoscopic surgery: A randomised trial.,"BACKGROUND


General anaesthesia for thoracoscopic lung surgery can be performed with the opioid-sparing strategies without intubation and may reduce the risk of glottic injury and enhance recovery after surgery. We therefore tested the primary hypothesis that avoiding intubation reduces glottic injury.
METHODS


Adults having elective thoracoscopic lung resections were randomised to: (1) intubated group: routine general anaesthesia with a double-lumen tube intubation; or, (2) non-intubated group: a bundle of opioid-sparing strategies, which included paravertebral blocks and total intravenous anaesthesia with minimal remifentanil infusion from 0.05 to 1.0 ng/mL (avoid sufentanil unless the respiratory rate exceeds 25/min or the systolic blood pressure exceeds 30% of the baseline value), no muscle relaxation, and spontaneous ventilation through a laryngeal mask. The primary outcome was glottal injury as determined by transnasal bronchoscopy one hour after removal of the laryngeal mask or double-lumen tube.
RESULTS


Two hundred seventeen patients were assessed for the primary outcome. Sufentanil use was reduced 96% and remifentanil was reduced 40% in non-intubated opioid-sparing patients. The incidence of glottal injury was 9% (10/109) in the non-intubated vs. 37% (40/108) in the intubated patients (RR: 0.25; 95%CI: 0.13-0.47, P < 0.001). The non-intubated group also had less postoperative sore throat (8% vs. 39%; P < 0.001) and hoarseness (3% vs. 19%; P < 0.001). Postoperative pulmonary complications and lung injury biomarkers did not differ between the groups. Compared to the intubated group, the non-intubated group had less postoperative pain, faster recovery, and improved quality-of-life scores.
CONCLUSIONS


Non-intubated opioid-sparing strategies for video-assisted lung resections reduce airway injury and promote postoperative recovery.
CLINICAL TRIAL NUMBER AND REGISTRY URL


ChiCTR1800018198 https://www.chictr.org.cn/showproj.aspx?proj=30780.",2022,"Compared to the intubated group, the non-intubated group had less postoperative pain, faster recovery, and improved quality-of-life scores.
","['Adults having elective thoracoscopic lung resections', 'Two hundred seventeen patients']","['General Anaesthesia with Double-lumen intubation', 'Sufentanil', 'remifentanil', 'Opioid-sparing Strategies with laryngeal mask for Thoracoscopic Surgery', 'intubated group: routine general anaesthesia with a double-lumen tube intubation; or, 2) non-intubated group: a bundle of opioid-sparing strategies, which included paravertebral blocks and total intravenous anaesthesia with minimal remifentanil infusion from 0.05∼1.0']","['postoperative sore throat', 'postoperative pain, faster recovery, and improved quality-of-life scores', 'systolic blood pressure', 'hoarseness', 'glottal injury as determined by transnasal bronchoscopy one hour after removal of the laryngeal mask or double-lumen tube', 'muscle relaxation, and spontaneous ventilation', 'incidence of glottal injury', 'Postoperative pulmonary complications and lung injury biomarkers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0026836', 'cui_str': 'Muscle relaxation'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",217.0,0.458657,"Compared to the intubated group, the non-intubated group had less postoperative pain, faster recovery, and improved quality-of-life scores.
","[{'ForeName': 'Chengya', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Anaesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Anaesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, China.'}, {'ForeName': 'Yaofeng', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Anaesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Anaesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, China.'}, {'ForeName': 'Jingxiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Anaesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, China; Outcomes Research Consortium, Cleveland, OH, USA. Electronic address: wjx1132@163.com.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2022.101083']
906,35472586,Effect of combined intraoperative use of the Nociception Level (NOL) and bispectral (BIS) indexes on desflurane administration.,"BACKGROUND


Currently, nociception monitors are not part of standard anaesthesia care. We investigated whether combined intraoperative nociception (NOL index) and anaesthesia (BIS index) monitoring during general anaesthesia would reduce anaesthetics consumption and enhance intraoperative safety and postoperative recovery when compared to standard of care monitoring (SOC).
METHODS


In this randomised study, we included 60 patients undergoing colonic surgery under desflurane/remifentanil anaesthesia and epidural analgesia. Patients received either standard monitoring or combined BIS + NOL index monitoring. In the monitored group, remifentanil infusion was titrated to achieve a NOL index below 20. Desflurane was adjusted to BIS values (45-55). In the SOC group, remifentanil and desflurane were titrated on vital signs and MAC. The primary outcome was intraoperative desflurane consumption.
RESULTS


Fifty-five patients were analysed. Desflurane administration was reduced in the monitored group from 0.25 ± 0.05 to 0.20 ± 0.06 mL kg -1  h -1  (p < 0.001). The cumulative time with a BIS under 40 was significantly higher in the SOC group with a median time of 12.6 min (95% CI: 0.6-80.0) versus 2.0 min (95% CI: 0.3-5.83) (p = 0.023). Time for extubation was significantly shorter in the monitored group: 4.4 min (95% CI: 2.4-4.9) versus 6.28 min (95% IC: 5.0-8.2) (p = 0.003). We observed no differences in remifentanil or phenylephrine requirements during anaesthesia or in postoperative outcome measures, such as postoperative pain, opioid consumption, neurocognitive recovery.
CONCLUSION


Combined intraoperative monitoring of anaesthesia and nociception during colonic surgery resulted in less desflurane consumption and quicker extubation time compared to standard clinical care monitoring.",2022,"We observed no differences in remifentanil or phenylephrine requirements during anaesthesia or in postoperative outcome measures, such as postoperative pain, opioid consumption, neurocognitive recovery.
","['55 patients', '60 patients undergoing colonic surgery under']","['desflurane/remifentanil anaesthesia and epidural analgesia', 'remifentanil', 'Desflurane', 'standard monitoring or combined BIS\u2009+\u2009NOL index monitoring', 'combined intraoperative nociception (NOL index) and anaesthesia (BIS index', 'remifentanil and desflurane']","['Time for extubation', 'Nociception Level (NOL) and bispectral (BIS) indexes', 'desflurane consumption and quicker extubation time', 'cumulative time with a BIS under 40', 'vital signs and MAC', 'intraoperative desflurane consumption', 'postoperative pain, opioid consumption, neurocognitive recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",60.0,0.340042,"We observed no differences in remifentanil or phenylephrine requirements during anaesthesia or in postoperative outcome measures, such as postoperative pain, opioid consumption, neurocognitive recovery.
","[{'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Renaud-Roy', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada; Department of Anesthesiology and Pain Medicine - Université de Montréal, 2900 Bd Edouard-Montpetit, Montréal, QC, H3T 1J4, Canada.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Morisson', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Brulotte', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada; Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR), CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada; Department of Anesthesiology and Pain Medicine - Université de Montréal, 2900 Bd Edouard-Montpetit, Montréal, QC, H3T 1J4, Canada.""}, {'ForeName': 'Moulay', 'Initials': 'M', 'LastName': 'Idrissi', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Godin', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada.""}, {'ForeName': 'Louis-Philippe', 'Initials': 'LP', 'LastName': 'Fortier', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada; Department of Anesthesiology and Pain Medicine - Université de Montréal, 2900 Bd Edouard-Montpetit, Montréal, QC, H3T 1J4, Canada.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Verdonck', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada; Department of Anesthesiology and Pain Medicine - Université de Montréal, 2900 Bd Edouard-Montpetit, Montréal, QC, H3T 1J4, Canada.""}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Choinière', 'Affiliation': 'Department of Anesthesiology and Pain Medicine - Université de Montréal, 2900 Bd Edouard-Montpetit, Montréal, QC, H3T 1J4, Canada; Centre de Recherche du CHUM (CR-CHUM), 900 rue Saint-Denis, Montréal, QC, H2X 0A9, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Richebé', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada; Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR), CIUSSS de l'Est de l'Ile de Montréal, 5415 Boulevard de l'Assomption, Montréal, QC, H1T 2M4, Canada; Department of Anesthesiology and Pain Medicine - Université de Montréal, 2900 Bd Edouard-Montpetit, Montréal, QC, H3T 1J4, Canada. Electronic address: philippe.richebe@umontreal.ca.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2022.101081']
907,35473809,"Prophylactic NAC promoted hematopoietic reconstitution by improving endothelial cells after haploidentical HSCT: a phase 3, open-label randomized trial.","BACKGROUND


Poor graft function (PGF) or prolonged isolated thrombocytopenia (PT), which are characterized by pancytopenia or thrombocytopenia, have become serious complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Our previous single-arm trial suggests that N-acetyl-L-cysteine (NAC) prophylaxis reduced PGF or PT after allo-HSCT. Therefore, an open-label, randomized, phase 3 trial was performed to investigate the efficacy and tolerability of NAC prophylaxis to reduce PGF or PT after allo-HSCT.
METHODS


A phase 3, open-label randomized trial was performed. Based on the percentage of CD34 + VEGFR2 (CD309) +  endothelial cells (ECs) in bone marrow (BM) detected by flow cytometry at 14 days before conditioning, patients aged 15 to 60 years with acute leukemia undergoing haploidentical HSCT were categorized as low-risk (EC ≥ 0.1%) or high-risk (EC < 0.1%); patients at high risk were randomly assigned (2:1) to receive NAC prophylaxis or nonprophylaxis. The primary endpoint was PGF and PT incidence at +60 days post-HSCT.
RESULTS


Between April 18, 2019, and June 24, 2021, 120 patients with BM EC <0.1% were randomly assigned for NAC (group A, N = 80) or nonprophylaxis (group B, N = 40), and 105 patients with EC≥0.1% (group C) were also analyzed. The +60 days incidence of PGF and PT was 7.5% (95% CI, 1.7 to 13.3%) and 22.5% (95% CI, 9.1 to 35.9%) in group A and group B (hazard ratio, 0.317; 95% CI, 0.113 to 0.890; P = 0.021) and 11.4% (95% CI, 5.2 to 17.6%) in group C (hazard ratio, 0.643; 95% CI, 0.242 to 1.715; P = 0.373). Consistently, NAC prophylaxis gradually improved BM ECs and CD34 +  cells in group A, whereas reduced their reactive oxygen species (ROS) levels post-HSCT. Within 60 days post-HSCT, the most common grade 3 to 5 adverse events for the NAC and control groups were infections (19/80 [24%] vs. 10/40 [25%]) and gastrointestinal adverse events (16/80 [20%] vs. 7/40 [18%]). There were no treatment-related deaths.
CONCLUSIONS


N-Acetyl-L-cysteine prophylaxis can prevent the occurrence of poor hematopoietic function and is well tolerated in haploidentical HSCT. It may offer a potential pathogenesis-oriented therapeutic approach for patients with poor hematopoietic function.
TRIAL REGISTRATION


This trial was registered at ClinicalTrials.gov as #NCT03967665.",2022,"Within 60 days post-HSCT, the most common grade 3 to 5 adverse events for the NAC and control groups were infections","['patients with poor hematopoietic function', 'Between April 18, 2019, and June 24, 2021, 120 patients with BM EC <0.1', 'patients aged 15 to 60 years with acute leukemia undergoing haploidentical HSCT were categorized as low-risk (EC ≥ 0.1%) or high-risk (EC < 0.1%); patients at high risk']","['NAC prophylaxis or nonprophylaxis', 'Prophylactic NAC', 'N-acetyl-L-cysteine (NAC) prophylaxis', 'allogeneic hematopoietic stem cell transplantation (allo-HSCT', 'nonprophylaxis', 'NAC']","['PGF and PT incidence', 'reactive oxygen species (ROS) levels', 'percentage of CD34 + VEGFR2 (CD309) +  endothelial cells (ECs) in bone marrow (BM', 'gastrointestinal adverse events', 'efficacy and tolerability', 'BM ECs and CD34 +  cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0054953', 'cui_str': 'Lymphocyte antigen CD34'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}]",120.0,0.393313,"Within 60 days post-HSCT, the most common grade 3 to 5 adverse events for the NAC and control groups were infections","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.""}, {'ForeName': 'Hong-Yan', 'Initials': 'HY', 'LastName': 'Zhao', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.""}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Zhang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.""}, {'ForeName': 'Ya-Zhe', 'Initials': 'YZ', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.""}, {'ForeName': 'Lan-Ping', 'Initials': 'LP', 'LastName': 'Xu', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.""}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.""}, {'ForeName': 'Kai-Yan', 'Initials': 'KY', 'LastName': 'Liu', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.""}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Huang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China. huangxiaojun@bjmu.edu.cn.""}]",BMC medicine,['10.1186/s12916-022-02338-9']
908,35473780,Patient Perceptions of Exertion and Dyspnea With Interleukin-1 Blockade in Patients With Recently Decompensated Systolic Heart Failure.,"Interleukin-1 (IL-1) blockade is an anti-inflammatory treatment that may affect exercise capacity in heart failure (HF). We evaluated patient-reported perceptions of exertion and dyspnea at submaximal exercise during cardiopulmonary exercise testing (CPET) in a double-blind, placebo-controlled, randomized clinical trial of IL-1 blockade in patients with systolic HF (REDHART [Recently Decompensated Heart Failure Anakinra Response Trial]). Patients underwent maximal CPET at baseline, 2, 4, and 12 weeks and rated their perceived level of exertion (RPE, on a scale from 6 to 20) and dyspnea on exertion (DOE, on a scale from 0 to 10) every 3 minutes throughout exercise. Patients also answered 2 questionnaires to assess HF-related quality of life: the Duke Activity Status Index and the Minnesota Living with Heart Failure Questionnaire. From baseline to the 12-week follow-up, IL-1 blockade significantly reduced RPE and DOE at 3- and 6-minutes during CPET without changing values for heart rate, oxygen consumption, and cardiac workload at 3- and 6-minutes. Linear regression identified 6-minute RPE to be a strong independent predictor of both physical symptoms (Minnesota Living with Heart Failure Questionnaire; β = 0.474, p = 0.002) and perceived exercise capacity (Duke Activity Status Index; β = -0.443, p = 0.008). In conclusion, patient perceptions of exertion and dyspnea at submaximal exercise may be valuable surrogates for quality of life and markers of response to IL-1 blockade in patients with HF.",2022,"Linear regression identified 6-minute RPE to be a strong independent predictor of both physical symptoms (Minnesota Living with Heart Failure Questionnaire; β = 0.474, p = 0.002) and perceived exercise capacity (Duke Activity Status Index; β = -0.443, p = 0.008).","['Patients', 'patients with systolic HF (REDHART [Recently Decompensated Heart Failure Anakinra Response Trial', 'patients with HF']","['IL-1 blockade', 'submaximal exercise during cardiopulmonary exercise testing (CPET', 'maximal CPET', 'placebo', 'Interleukin-1 (IL-1) blockade']","['perceived exercise capacity', 'heart rate, oxygen consumption, and cardiac workload', 'RPE and DOE', 'HF-related quality of life: the Duke Activity Status Index and the Minnesota Living with Heart Failure Questionnaire', 'dyspnea on exertion (DOE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4720913', 'cui_str': 'Duke activity status index'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}]",,0.323451,"Linear regression identified 6-minute RPE to be a strong independent predictor of both physical symptoms (Minnesota Living with Heart Failure Questionnaire; β = 0.474, p = 0.002) and perceived exercise capacity (Duke Activity Status Index; β = -0.443, p = 0.008).","[{'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Mihalick', 'Affiliation': 'VCU Pauley Heart Center; Department of Pharmacotherapy & Outcomes Sciences.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wohlford', 'Affiliation': 'Department of Pharmacotherapy & Outcomes Sciences.'}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Department of Pharmacotherapy & Outcomes Sciences.'}, {'ForeName': 'Ai-Chen Jane', 'Initials': 'AJ', 'LastName': 'Ho', 'Affiliation': 'Department of Pharmacotherapy & Outcomes Sciences.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Kim', 'Affiliation': 'Department of Pharmacotherapy & Outcomes Sciences.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Canada', 'Affiliation': 'VCU Pauley Heart Center.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Carbone', 'Affiliation': 'VCU Pauley Heart Center; Department of Kinesiology & Health Sciences, College of Humanities & Sciences, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kadariya', 'Affiliation': 'VCU Pauley Heart Center.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Billingsley', 'Affiliation': 'Department of Kinesiology & Health Sciences, College of Humanities & Sciences, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Trankle', 'Affiliation': 'VCU Pauley Heart Center.'}, {'ForeName': 'Marco Giuseppe', 'Initials': 'MG', 'LastName': 'Del Buono', 'Affiliation': 'VCU Pauley Heart Center.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Moroni', 'Affiliation': 'VCU Pauley Heart Center.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'VCU Pauley Heart Center.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Van Tassell', 'Affiliation': 'Department of Pharmacotherapy & Outcomes Sciences. Electronic address: bvantassell@vcu.edu.'}]",The American journal of cardiology,['10.1016/j.amjcard.2022.03.026']
909,35481935,Portable air cleaners and residential exposure to SARS-CoV-2 aerosols: A real-world study.,"Individuals with COVID-19 who do not require hospitalization are instructed to self-isolate in their residences. Due to high secondary infection rates in household members, there is a need to understand airborne transmission of SARS-CoV-2 within residences. We report the first naturalistic intervention study suggesting a reduction of such transmission risk using portable air cleaners (PACs) with HEPA filters. Seventeen individuals with newly diagnosed COVID-19 infection completed this single-blind, crossover, randomized study. Total and size-fractionated aerosol samples were collected simultaneously in the self-isolation room with the PAC (primary) and another room (secondary) for two consecutive 24-h periods, one period with HEPA filtration and the other with the filter removed (sham). Seven out of sixteen (44%) air samples in primary rooms were positive for SARS-CoV-2 RNA during the sham period. With the PAC operated at its lowest setting (clean air delivery rate [CADR] = 263 cfm) to minimize noise, positive aerosol samples decreased to four out of sixteen residences (25%; p = 0.229). A slight decrease in positive aerosol samples was also observed in the secondary room. As the world confronts both new variants and limited vaccination rates, our study supports this practical intervention to reduce the presence of viral aerosols in a real-world setting.",2022,Seven out of sixteen (44%) air samples in primary rooms were positive for SARS-CoV-2 RNA during the sham period.,"['Individuals with COVID-19 who do not require hospitalization are instructed to self-isolate in their residences', 'Seventeen individuals with newly diagnosed COVID-19 infection']","['Portable air cleaners and residential exposure to SARS-CoV-2 aerosols', 'portable air cleaners (PACs) with HEPA filters']","['positive aerosol samples', 'positive for SARS-CoV-2 RNA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0789995', 'cui_str': 'Air cleaner'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0180860', 'cui_str': 'Filter'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",17.0,0.140341,Seven out of sixteen (44%) air samples in primary rooms were positive for SARS-CoV-2 RNA during the sham period.,"[{'ForeName': 'Nirmala T', 'Initials': 'NT', 'LastName': 'Myers', 'Affiliation': 'Department of Environmental Sciences, Rutgers University, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Laumbach', 'Affiliation': 'Rutgers Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, New Jersey, USA.'}, {'ForeName': 'Kathleen G', 'Initials': 'KG', 'LastName': 'Black', 'Affiliation': 'Rutgers Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, New Jersey, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ohman-Strickland', 'Affiliation': 'Rutgers Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, New Jersey, USA.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Alimokhtari', 'Affiliation': 'Rutgers Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, New Jersey, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Legard', 'Affiliation': 'Rutgers Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, New Jersey, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'De Resende', 'Affiliation': 'Rutgers Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, New Jersey, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Calderón', 'Affiliation': 'Department of Environmental Sciences, Rutgers University, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Frederic T', 'Initials': 'FT', 'LastName': 'Lu', 'Affiliation': 'Rutgers Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, New Jersey, USA.'}, {'ForeName': 'Gediminas', 'Initials': 'G', 'LastName': 'Mainelis', 'Affiliation': 'Department of Environmental Sciences, Rutgers University, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Kipen', 'Affiliation': 'Rutgers Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, New Jersey, USA.'}]",Indoor air,['10.1111/ina.13029']
910,35481934,Dibutyl phthalate exposure alters T-cell subsets in blood from allergen-sensitized volunteers.,"Phthalates are ubiquitous environmental contaminants associated with allergic disease in epidemiological and animal studies. This investigation aims to support these associations by interrogating systemic immune effects in allergen-sensitized volunteers after controlled indoor air exposure to a known concentration of dibutyl phthalate (DBP). The phthalate-allergen immune response (PAIR) study enrolled 16 allergen-sensitized participants to a double-blinded, randomized, crossover exposure to two conditions (DBP or control air for 3 hr), each followed immediately by inhaled allergen challenge. Peripheral blood immune cell composition and activation along with inflammatory mediators were measured before and after exposure. DBP exposure prior to the inhaled allergen challenge increased the percentage of CD4 +  T helper cells and decreased the percentage of regulatory T cells (3 hr and 20 hr post-exposure), while only modest overall effects were observed for inflammatory mediators. The cells and mediators affected by the phthalate exposure were generally not overlapping with the endpoints affected by allergen inhalation alone. Thus, in distinction to our previously published effects on lung function, DBP appears to alter endpoints in peripheral blood that are not necessarily enhanced by allergen alone. Further studies are needed to clarify the role of phthalate-induced systemic effects in disease pathogenesis.",2022,"DBP exposure prior to the inhaled allergen challenge increased the percentage of CD4 +  T helper cells and decreased the percentage of regulatory T cells (3 hr and 20 hr post-exposure), while only modest overall effects were observed for inflammatory mediators.","['allergen-sensitized volunteers after controlled indoor air exposure to a known concentration of dibutyl phthalate (DBP', 'blood from allergen-sensitized volunteers', 'The phthalate-allergen immune response (PAIR) study enrolled 16 allergen-sensitized participants']","['conditions (DBP or control air for 3\xa0hr), each followed immediately by inhaled allergen challenge']","['percentage of regulatory T cells', 'Peripheral blood immune cell composition and activation along with inflammatory mediators', 'percentage of CD4 +  T helper cells']","[{'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0012052', 'cui_str': 'Dibutyl Phthalate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0220894', 'cui_str': 'Phthalic acid ester'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0012052', 'cui_str': 'Dibutyl Phthalate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}]",16.0,0.0596461,"DBP exposure prior to the inhaled allergen challenge increased the percentage of CD4 +  T helper cells and decreased the percentage of regulatory T cells (3 hr and 20 hr post-exposure), while only modest overall effects were observed for inflammatory mediators.","[{'ForeName': 'Danay', 'Initials': 'D', 'LastName': 'Maestre-Batlle', 'Affiliation': 'Department of Medicine, Air Pollution Exposure Lab and Legacy for Airway Health, University of British Columbia and Vancouver Coastal Health, Vancouver, Canada.'}, {'ForeName': 'Unni C', 'Initials': 'UC', 'LastName': 'Nygaard', 'Affiliation': 'Department of Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Huff', 'Affiliation': 'Department of Medicine, Air Pollution Exposure Lab and Legacy for Airway Health, University of British Columbia and Vancouver Coastal Health, Vancouver, Canada.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Alexis', 'Affiliation': 'Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Tebbutt', 'Affiliation': 'Department of Medicine, PROOF Centre of Excellence, & Centre for Heart Lung Innovation, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Stuart E', 'Initials': 'SE', 'LastName': 'Turvey', 'Affiliation': ""Department of Pediatrics, BC Children's Hospital, University of British Columbia, Vancouver, Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Department of Medicine, Air Pollution Exposure Lab and Legacy for Airway Health, University of British Columbia and Vancouver Coastal Health, Vancouver, Canada.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Kocbach Bølling', 'Affiliation': 'Department of Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.'}]",Indoor air,['10.1111/ina.13026']
911,35483387,"Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial.","BACKGROUND


Treatment with natalizumab once every 4 weeks is approved for patients with relapsing-remitting multiple sclerosis, but is associated with a risk of progressive multifocal leukoencephalopathy. Switching to extended-interval dosing is associated with lower progressive multifocal leukoencephalopathy risk, but the efficacy of this approach is unclear. We aimed to assess the safety and efficacy of natalizumab once every 6 weeks compared with once every 4 weeks in patients with relapsing-remitting multiple sclerosis.
METHODS


We did a randomised, controlled, open-label, phase 3b trial (NOVA) at 89 multiple sclerosis centres across 11 countries in the Americas, Europe, and Western Pacific. Included participants were aged 18-60 years with relapsing-remitting multiple sclerosis and had been treated with intravenous natalizumab 300 mg once every 4 weeks with no relapses for at least 12 months before randomisation, with no missed doses in the previous 3 months. Participants were randomly assigned (1:1), using a randomisation sequence generated by the study funder and contract personnel with interactive response technology, to switch to natalizumab once every 6 weeks or continue with once every 4 weeks. The centralised MRI reader, independent neurology evaluation committee, site examining neurologists, site backup examining neurologists, and site examining technicians were masked to study group assignments. The primary endpoint was the number of new or newly enlarging T2 hyperintense lesions at week 72, assessed in all participants who received at least one dose of assigned treatment and had at least one postbaseline MRI, relapse, or neurological examination or efficacy assessment. Missing primary endpoint data were handled under prespecified primary and secondary estimands: the primary estimand included all data, regardless of whether participants remained on the assigned treatment; the secondary estimand classed all data obtained after treatment discontinuation or study withdrawal as missing. Safety was assessed in all participants who received at least one dose of study treatment. Study enrolment is closed and an open-label extension study is ongoing. This study is registered with EudraCT, 2018-002145-11, and ClinicalTrials.gov, NCT03689972.
FINDINGS


Between Dec 26, 2018, and Aug 30, 2019, 605 patients were assessed for eligibility and 499 were enrolled and assigned to receive natalizumab once every 6 weeks (n=251) or once every 4 weeks (n=248). After prespecified adjustments for missing data, mean numbers of new or newly enlarging T2 hyperintense lesions at week 72 were 0·20 (95% CI 0·07-0·63) in the once every 6 weeks group and 0·05 (0·01-0·22) in the once every 4 weeks group (mean lesion ratio 4·24 [95% CI 0·86-20·85]; p=0·076) under the primary estimand, and 0·31 (95% CI 0·12-0·82) and 0·06 (0·01-0·31; mean lesion ratio 4·93 [95% CI 1·05-23·20]; p=0·044) under the secondary estimand. Two participants in the once every 6 weeks group with extreme new or newly enlarging T2 hyperintense lesion numbers (≥25) contributed most of the excess lesions. Adverse events occurred in 194 (78%) of 250 participants in the once every 6 weeks group and 190 (77%) of 247 in the once every 4 weeks group, and serious adverse events occurred in 17 (7%) and 17 (7%), respectively. No deaths were reported. There was one case of asymptomatic progressive multifocal leukoencephalopathy (without clinical signs) in the once every 6 weeks group, and no cases in the once every 4 weeks group; 6 months after diagnosis, the participant was without increased disability and remained classified as asymptomatic.
INTERPRETATION


We found a numerical difference in the mean number of new or newly enlarging T2 hyperintense lesions at week 72 between the once every 6 weeks and once every 4 weeks groups, which reached significance under the secondary estimand, but interpretation of statistical differences (or absence thereof) is limited because disease activity in the once every 4 weeks group was lower than expected. The safety profiles of natalizumab once every 6 weeks and once every 4 weeks were similar. Although this trial was not powered to assess differences in risk of progressive multifocal leukoencephalopathy, the occurrence of the (asymptomatic) case underscores the importance of monitoring and risk factor consideration in all patients receiving natalizumab.
FUNDING


Biogen.",2022,No deaths were reported.,"['patients with relapsing-remitting multiple sclerosis (NOVA', 'Between Dec 26, 2018, and Aug 30, 2019, 605 patients were assessed for eligibility and 499 were enrolled and assigned to receive', 'Included participants were aged 18-60 years with relapsing-remitting multiple sclerosis and had been treated with', '89 multiple sclerosis centres across 11 countries in the Americas, Europe, and Western Pacific', 'patients with relapsing-remitting multiple sclerosis']","['intravenous natalizumab', 'natalizumab']","['postbaseline MRI, relapse, or neurological examination or efficacy assessment', 'Adverse events', 'mean number of new or newly enlarging T2 hyperintense lesions', 'serious adverse events', 'asymptomatic progressive multifocal leukoencephalopathy', 'safety and efficacy', 'number of new or newly enlarging T2 hyperintense lesions', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0023524', 'cui_str': 'Progressive multifocal leukoencephalopathy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",605.0,0.31206,No deaths were reported.,"[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Foley', 'Affiliation': 'Rocky Mountain MS Clinic, Salt Lake City, UT, USA. Electronic address: jfoley@rmmsc.com.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Defer', 'Affiliation': 'Department of Neurology, Centre Hospitalier Universitaire de Caen, Caen, France.'}, {'ForeName': 'Lana Zhovtis', 'Initials': 'LZ', 'LastName': 'Ryerson', 'Affiliation': 'NYU Multiple Sclerosis Center, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cohen', 'Affiliation': 'Mellen MS Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montréal, QC, Canada; NeuroRx Research, Montréal, QC, Canada.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Butzkueven', 'Affiliation': 'Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'University of Alabama at Birmingham, School of Public Health, Birmingham, AL, USA.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK; Queen Mary University of London, London, UK.'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Killestein', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Smirnakis', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kong', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kuhelj', 'Affiliation': 'Biogen, Baar, Switzerland.'}, {'ForeName': 'Nolan', 'Initials': 'N', 'LastName': 'Campbell', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(22)00143-0']
912,35483209,"Effect of Airborne Low Intensity Multi frequency ultrasound (ALIMFUS) on glycemic control, lipid profile and markers of inflammation in patients with uncontrolled type 2 diabetes: A multicentre proof of concept, randomized double blind Placebo controlled study.","BACKGROUND AND AIMS


Airborne Low Intensity Multi frequency Ultrasound (ALIMFUS) uses thermal and non thermal principal of ultrasound to facilitate transportation of drugs into the cells and it's metabolism. This is randomized, multi-center, Double Blind, Interventional, Placebo Controlled Study to evaluate efficacy and safety of ALIMFUS as an Add-on therapy to Oral Hypoglycemic Agent (OHA) in Type 2 DM.
METHODS


Total 103/186 subjects completed the study and received 10 min either ALIMFUS therapy on alternate day for 90 days or placebo. Baseline and end of the study Lab parameters like HbA1c, blood sugars, Lipid Profile, Serum Hs-CRP, Serum Interleukin-6, Serum TNF-α, Serum homocysteine, Serum Vitamin D, Serum Leptin, Serum Adiponectin and Quality of Life score were assessed.
RESULTS


At the end of study ALIMFUS group achieved greater (0.77 ± 1.13 vs 0.48 ± 0.79) but non-significant reduction in HbA1c. More subjects in ALIMFUS group (30.76% vs 27.45%) achieved HbA1c < 7%. Significant reduction in fasting and postprandial glucose noted in both groups whose baseline HbA1c was ≥8%. Significant reduction in lipid profile noted in ALIMFUS group compared to placebo. Insulin, adiponectin, CRP and homocysteine and quality of life were significantly better in ALMFUS group compared to baseline; but non-significant compared to placebo. No adverse events were associated with ALIMFUS.
CONCLUSIONS


Thus, ALIMFUS could be novel technology in diabetes management for patient unable to achieve glycemic targets on combination therapy. However further exploratory long term studies are required to demonstrate its effective role as add-on therapy in diabetes management.",2022,"Insulin, adiponectin, CRP and homocysteine and quality of life were significantly better in ALMFUS group compared to baseline; but non-significant compared to placebo.","['Total 103/186 subjects completed the study and received', 'patients with uncontrolled type 2 diabetes']","['10\xa0min either ALIMFUS therapy', 'Airborne Low Intensity Multi frequency ultrasound (ALIMFUS', 'ALIMFUS', 'ALMFUS', 'Placebo', 'Airborne Low Intensity Multi frequency Ultrasound (ALIMFUS', 'placebo']","['adverse events', 'Insulin, adiponectin, CRP and homocysteine and quality of life', 'glycemic control, lipid profile and markers of inflammation', 'lipid profile', 'Lab parameters like HbA1c, blood sugars, Lipid Profile, Serum Hs-CRP, Serum Interleukin-6, Serum TNF-α, Serum homocysteine, Serum Vitamin D, Serum Leptin, Serum Adiponectin and Quality of Life score', 'fasting and postprandial glucose']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.103395,"Insulin, adiponectin, CRP and homocysteine and quality of life were significantly better in ALMFUS group compared to baseline; but non-significant compared to placebo.","[{'ForeName': 'Vyankatesh', 'Initials': 'V', 'LastName': 'Shivane', 'Affiliation': 'Sadhana Diabesity Clinic, Prabhadevi, Mumbai, India. Electronic address: drvkshivane@gmail.com.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Pathak', 'Affiliation': 'Seth G S Medical College & KEM Hospital, Mumbai, India. Electronic address: drhp68@gmail.com.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Tamoli', 'Affiliation': 'Target Institute of Medical Education and Research, Mumbai, India. Electronic address: sanjaytamoli@hotmail.com.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Kohli', 'Affiliation': 'Govt of Maharashtra, Mumbai, India. Electronic address: kohliayurveda@gmail.com.'}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Ghungralekar', 'Affiliation': 'Dept of Kayachikitsa, R A Podar Medical (Ayu) College, Mumbai, India. Electronic address: ghungralekar@gmail.com.'}, {'ForeName': 'Pranita', 'Initials': 'P', 'LastName': 'Deshmukh', 'Affiliation': 'Research Methodology & Statistics, Sumatibhai Shah Hospital, Hadapsar, Pune, India. Electronic address: pranitaj@gmail.com.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Hartalkar', 'Affiliation': 'Sumatibhai Shah Hospital, Hadapsar, Pune, India. Electronic address: amolhartalkar@gmail.com.'}, {'ForeName': 'Swapnali', 'Initials': 'S', 'LastName': 'Mahadik', 'Affiliation': 'Target Institute of Medical Education and Research, Mumbai, India. Electronic address: drswapnali@targetinstitute.in.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Indalkar', 'Affiliation': 'Sadhana Diabesity Clinic, Prabhadevi, Mumbai, India. Electronic address: indalkarpradeep27@gmail.com.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mehta', 'Affiliation': 'Aquatic Remedies, Mumbai, India. Electronic address: aquaticremedies@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2022.102483']
913,35487422,Ultrasound-guided versus laparoscopic-guided subcostal transversus abdominis plane (TAP) block versus No TAP block in laparoscopic cholecystectomy; a randomized double-blind controlled trial.,"BACKGROUND


Transversus abdominis plane (TAP) block is an effective modality for the control of immediate postoperative pain. The present randomized trial aimed to assess the efficacy of ultrasound-guided subcostal TAP (USTAP) and laparoscopic subcostal TAP (LSTAP) block as compared to standard care without TAP block after laparoscopic cholecystectomy.
METHODS


This was a prospective, randomized, controlled trial on patients who underwent laparoscopic cholecystectomy. Patients were equally randomized to one of three groups: USTAP, LSTAP, and control group (no TAP block). The main outcome measures were pain scores and analgesic consumption within the first 24 h postoperatively, postoperative nausea and vomiting (PONV), time to ambulation, time to first flatus, and adverse effects of TAP block.
RESULTS


The trial included 110 patients (90% females) with a mean age of 40.9 ± 11.7 years. Both USTAP and LSTAP block groups were associated with significantly lower pain scores at 2, 6, 12, and 24 h postoperatively, lower cumulative dose of paracetamol, less PONV, and shorter time to flatus than the control group. USTAP and LSTAP block were associated with similar pain scores at all time points, similar analgesic requirements, a similar incidence of PONV, and comparable time to first ambulation and time to first flatus. No adverse effects related to TAP block were recorded.
CONCLUSIONS


TAP block is a safe and effective method for pain control and improving recovery after laparoscopic cholecystectomy. Both USTAP and LSTAP blocks were equally effective in terms of pain relief, analgesic requirements, PONV, return of bowel function, and time to ambulation.",2022,"Both USTAP and LSTAP blocks were equally effective in terms of pain relief, analgesic requirements, PONV, return of bowel function, and time to ambulation.","['laparoscopic cholecystectomy', '110 patients (90% females) with a mean age of 40.9\u202f±\u202f11.7 years', 'patients who underwent']","['laparoscopic cholecystectomy', 'Transversus abdominis plane (TAP) block', 'Ultrasound-guided versus laparoscopic-guided subcostal transversus abdominis plane (TAP) block versus No TAP block', 'TAP block', 'USTAP, LSTAP, and control group (no TAP block', 'ultrasound-guided subcostal TAP (USTAP) and laparoscopic subcostal TAP (LSTAP) block']","['cumulative dose of paracetamol, less PONV, and shorter time to flatus', 'pain scores', 'pain scores and analgesic consumption within the first 24 hours postoperatively, postoperative nausea and vomiting (PONV), time to ambulation, time to first flatus, and adverse effects of TAP block', 'time to first ambulation and time to first flatus', 'pain relief, analgesic requirements, PONV, return of bowel function, and time to ambulation']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",110.0,0.267729,"Both USTAP and LSTAP blocks were equally effective in terms of pain relief, analgesic requirements, PONV, return of bowel function, and time to ambulation.","[{'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura, Egypt. Electronic address: Sameh200@hotmail.com.'}, {'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Elfeki', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura, Egypt. Electronic address: hossamelfeki@gmail.com.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Elbahrawy', 'Affiliation': 'Department of Anesthesia, Mansoura University Hospitals, Mansoura University, Egypt. Electronic address: elbahrawy_khaled@yahoo.com.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sakr', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura, Egypt. Electronic address: ahmadsakr1987@gmail.com.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Shalaby', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura, Egypt. Electronic address: mostafashalaby@mans.edu.eg.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2022.106639']
914,35489301,"Health-related quality of life in patients with advanced well-differentiated pancreatic and extrapancreatic neuroendocrine tumors treated with surufatinib versus placebo: Results from two randomized, double-blind, phase III trials (SANET-p and SANET-ep).","AIM


To investigate the health-related quality of life (HRQoL) of patients who had neuroendocrine tumors (NETs) from SANET trials.
METHODS


Eligible patients were randomized in a 2:1 ratio to receive surufatinib or placebo. HRQoL questionnaires, including the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-G.I.NET21, were collected. The prespecified HRQoL outcome was the mean change of scores from baseline to the last available visit for each domain. Time until definitive deterioration (TUDD) was defined as the time from randomization to deterioration of ≥10 points from baseline in domain score, disease progression, or death.
RESULTS


370 patients were enrolled and randomly assigned to surufatinib (n = 242) or placebo (n = 128). No significant difference in mean scores change from baseline to the last available visit was observed for QLQ-C30 and QLQ- G.I.NET21 domains, with the exception of diarrhea. The mean score of diarrhea increased 11.7 points from baseline in the surufatinib arm and decreased 1.2 points in the placebo arm, and the between-group difference was 12.9 points. Compared with placebo, surufatinib treated patients had a significantly longer TUDD for dyspnea (hazard ratio [HR] 0.58; 95% confidence interval [CI], 0.39-0.86; P = 0.0058) and a significantly shorter TUDD for diarrhea (HR 2.91; 95% CI, 1.66-5.10; P < 0.0001). There were no significant differences in TUDD for the remaining domains of QLQ-C30 and G.I.NET-21.
CONCLUSIONS


HRQoL was similar in patients treated with surufatinib and placebo except for diarrhea. The preservation of HRQoL supports surufatinib as a treatment option for NETs.
CLINICAL TRIAL INFORMATION


ClinicalTrials.gov: NCT02589821, NCT02588170.",2022,"No significant difference in mean scores change from baseline to the last available visit was observed for QLQ-C30 and QLQ- G.I.NET21 domains, with the exception of diarrhea.","['patients with advanced well-differentiated pancreatic and extrapancreatic neuroendocrine tumors treated with surufatinib versus', '370 patients were enrolled and randomly assigned to surufatinib (n\xa0=\xa0242) or', 'Eligible patients', 'patients who had neuroendocrine tumors (NETs) from SANET trials']","['placebo', 'surufatinib or placebo']","['health-related quality of life (HRQoL', 'Time until definitive deterioration (TUDD', 'mean scores change', 'Health-related quality of life', 'domain score, disease progression, or death', 'diarrhea', 'longer TUDD for dyspnea (hazard ratio [HR', 'mean score of diarrhea', 'TUDD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",370.0,0.646228,"No significant difference in mean scores change from baseline to the last available visit was observed for QLQ-C30 and QLQ- G.I.NET21 domains, with the exception of diarrhea.","[{'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuejuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: baichunmei1964@163.com.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China. Electronic address: jmxu2003@yahoo.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China. Electronic address: linshenpku@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Abdominal Oncology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yihebali', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xianjun', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Enxiao', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Department of Clinical and Regulatory Affairs, HUTCHMED, Shanghai, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical and Regulatory Affairs, HUTCHMED, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Clinical and Regulatory Affairs, HUTCHMED, Shanghai, China.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.03.027']
915,35489233,Impact of trough concentrations of regorafenib and its major metabolites M-2 and M-5 on overall survival of chemorefractory metastatic colorectal cancer patients: Results from a multicentre GERCOR TEXCAN phase II study.,"PURPOSE


This prospective pharmacokinetic (PK) ancillary study of the TEXCAN phase II GERCOR trial of patients with chemorefractory metastatic colorectal cancer and treated with regorafenib (REGO) investigated correlations between overall survival (OS) and concentrations (C) of REGO and its active metabolites, M-2 and M-5.
METHODS


55 patients received REGO 160 mg/day for 21 days of a 28-day cycle (NCT02699073). REGO, M-2, M-5 were measured by liquid chromatography-mass spectrometry assay on day 15 of cycle 1 (C1) and 2 (C2). We studied the association between OS and Cmin of REGO, M-2 and M-5 at C1 and their accumulations between C1 and C2.
RESULTS


Medians of C2/C1 M-2 and M-5 ratios were 0.82 (interquartile range 0.50-1.78) and 0.75 (interquartile range 0.41-1.93), respectively. Patients with C2/C1 M-2 ratio ≥ median had improved survival compared to those < median (12.6 versus 4.0 months, P = 0.023), corresponding to a 66% mortality risk reduction in multivariate analysis. The C2/C1 M-2 ratio correlated with C1 REGO+M-2+M-5 (Csum; P = 0.006). Restricted cubic spline analysis showed an increased OS benefit as the C2/C1 M-2 ratio raises and when C1 Csum ranged between 2.5 and 5.5 mg/L. Patients within the Csum range had a reduced incidence of serious adverse events and improved OS.
CONCLUSIONS


We identified PK parameters associated with a survival benefit in patients with metastatic colorectal cancer treated by REGO. OS and safety were favourable when C1 REGO+M-2+M-5 Csum ranged between 2.5 and 5.5 mg/L. These results pave the way for individual REGO dose modification strategies based on PK monitoring.
CLINICAL TRIAL REFERENCE


NCT02699073.",2022,"RESULTS


Medians of C2/C1 M-2 and M-5 ratios were 0.82","['chemorefractory metastatic colorectal cancer patients', 'patients with metastatic colorectal cancer treated by REGO', 'patients with chemorefractory metastatic colorectal cancer and treated with', '55 patients received']","['TEXCAN', 'REGO', 'regorafenib (REGO', 'regorafenib and its major metabolites M-2 and M-5', 'C1 REGO+M-2+M-5']","['C2/C1 M-2 ratio', 'OS benefit', 'survival benefit', 'REGO, M-2, M-5', 'serious adverse events and improved OS', 'OS and safety', 'survival', 'overall survival (OS) and concentrations (C) of REGO and its active metabolites, M-2 and M-5', 'C2/C1 M-2 and M-5 ratios']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0618333', 'cui_str': '21-hydroxy-9beta,10alpha-pregna-5,7-diene-3-ol-20-one'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",,0.117617,"RESULTS


Medians of C2/C1 M-2 and M-5 ratios were 0.82","[{'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Rousseau', 'Affiliation': 'Department of Medical Oncology, Henri Mondor Hospital, APHP, Creteil, France; Memorial Sloan Kettering Cancer Center, New York, USA; Pharmacology Unit, Henri Mondor Hospital, APHP, Creteil, France; GERCOR, Paris, France. Electronic address: rousseab@mskcc.org.'}, {'ForeName': 'Arezki K', 'Initials': 'AK', 'LastName': 'Boukerma', 'Affiliation': 'Pharmacology Unit, Henri Mondor Hospital, APHP, Creteil, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Henriques', 'Affiliation': 'Methodology and Quality of Life Unit, Department of Medical Oncology, University Hospital, Besançon, France; Bourgogne Franche-Comté University, INSERM, Etablissement Français Du Sang Bourgogne Franche-Comté, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, UMR1098, Besançon, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'GERCOR, Paris, France; Sorbonne University and Department of Medical Oncology, Saint-Antoine Hospital, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lucidarme', 'Affiliation': 'Sorbonne University and Radiology Unit, Pitié-Salpétrière Hospital, APHP, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'GERCOR, Paris, France; Department of Medical Oncology, Besancon University Hospital, Besancon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': 'Department of Medical Oncology, Henri Mondor Hospital, APHP, Creteil, France; GERCOR, Paris, France.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'GERCOR, Paris, France; Department of Medical Oncology, Besancon University Hospital, Besancon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'GERCOR, Paris, France; Sorbonne University and Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Mazard', 'Affiliation': 'Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Université de Montpellier, Institut Régional Du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'GERCOR, Paris, France; Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Benoist', 'Initials': 'B', 'LastName': 'Chibaudel', 'Affiliation': 'Medical Oncology, Institut Hospitalier Franco-Britannique-Levallois-Perret, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'GERCOR, Paris, France; Methodology and Quality of Life Unit, Department of Medical Oncology, University Hospital, Besançon, France; Bourgogne Franche-Comté University, INSERM, Etablissement Français Du Sang Bourgogne Franche-Comté, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, UMR1098, Besançon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Andre', 'Affiliation': 'GERCOR, Paris, France; Sorbonne University and Department of Medical Oncology, Saint-Antoine Hospital, Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hulin', 'Affiliation': 'Pharmacology Unit, Henri Mondor Hospital, APHP, Creteil, France; GERCOR, Paris, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.03.009']
916,35490461,"Liver alterations are not improved by inulin supplementation in alcohol use disorder patients during alcohol withdrawal: A pilot randomized, double-blind, placebo-controlled study.","BACKGROUND


Emerging evidence highlights that targeting the gut microbiota could be an interesting approach to improve alcohol liver disease due to its important plasticity. This study aimed to evaluate the effects of inulin supplementation on liver parameters in alcohol use disorder (AUD) patients (whole sample) and in a subpopulation with early alcohol-associated liver disease (eALD).
METHODS


Fifty AUD patients, hospitalized for a 3-week detoxification program, were enrolled in a randomized, double-blind, placebo-controlled study and assigned to prebiotic (inulin) versus placebo for 17 days. Liver damage, microbial translocation, inflammatory markers and 16S rDNA sequencing were measured at the beginning (T1) and at the end of the study (T2).
FINDINGS


Compared to placebo, AST (β = 8.55, 95% CI [2.33:14.77]), ALT (β = 6.01, 95% CI [2.02:10.00]) and IL-18 (β = 113.86, 95% CI [23.02:204.71]) were statistically significantly higher in the inulin group in the whole sample at T2. In the eALD subgroup, inulin supplementation leads to specific changes in the gut microbiota, including an increase in Bifidobacterium and a decrease of Bacteroides. Despite those changes, AST (β = 14.63, 95% CI [0.91:28.35]) and ALT (β = 10.40, 95% CI [1.93:18.88]) at T2 were higher in the inulin group compared to placebo. Treatment was well tolerated without important adverse events or side effects.
INTERPRETATION


This pilot study shows that 17 days of inulin supplementation versus placebo, even though it induces specific changes in the gut microbiota, did not alleviate liver damage in AUD patients. Further studies with a larger sample size and duration of supplementation with adequate monitoring of liver parameters are needed to confirm these results. Gut2Brain study: https://clinicaltrials.gov/ct2/show/NCT03803709 FUNDING: Fédération Wallonie-Bruxelles, FRS-FNRS, Fondation Saint-Luc.",2022,"Compared to placebo, AST (β = 8.55, 95% CI [2.33:14.77]), ALT (β = ","['alcohol use disorder (AUD) patients (whole sample) and in a subpopulation with early alcohol-associated liver disease (eALD', 'alcohol use disorder patients during alcohol withdrawal', 'Fifty AUD patients, hospitalized for a 3-week detoxification program', 'AUD patients']","['prebiotic (inulin) versus placebo', 'inulin supplementation', 'placebo, AST', 'inulin supplementation versus placebo', 'placebo']","['Liver damage, microbial translocation, inflammatory markers and 16S rDNA sequencing', 'tolerated without important adverse events or side effects', 'Bacteroides']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0236663', 'cui_str': 'Alcohol withdrawal syndrome'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]","[{'cui': 'C0151763', 'cui_str': 'Liver damage'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",50.0,0.394639,"Compared to placebo, AST (β = 8.55, 95% CI [2.33:14.77]), ALT (β = ","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Amadieu', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, UCLouvain, Brussels, Belgium; Institute of Neuroscience, Université catholique de Louvain, UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Maccioni', 'Affiliation': 'Institute of Experimental and Clinical Research, Laboratory of Hepato-Gastroenterology, Université catholique de Louvain, UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Leclercq', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, UCLouvain, Brussels, Belgium; Institute of Neuroscience, Université catholique de Louvain, UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Audrey M', 'Initials': 'AM', 'LastName': 'Neyrinck', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'de Timary', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, UCLouvain, Brussels, Belgium; Department of Adult Psychiatry, Cliniques universitaires Saint Luc, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stärkel', 'Affiliation': 'Department of Hepato-Gastroenterology, Cliniques Universitaires Saint-Luc, Brussels, Belgium; Institute of Experimental and Clinical Research, Laboratory of Hepato-Gastroenterology, Université catholique de Louvain, UCLouvain, Brussels, Belgium. Electronic address: peter.starkel@uclouvain.be.'}]",EBioMedicine,['10.1016/j.ebiom.2022.104033']
917,35504178,Interleukin-6 inhibition in ST-elevation myocardial infarction: Immune cell profile in the randomised ASSAIL-MI trial.,"BACKGROUND


We recently showed that interleukin (IL)-6 inhibition by tocilizumab improves myocardial salvage in ST-elevation myocardial infarction (STEMI). However, the mechanisms for this effect are not clear.
METHODS


In this exploratory sub-study of the ASSAIL-MI trial, we examined leukocyte differential counts and their relation to myocardial salvage and peak troponin T (TnT) in STEMI patients randomised to tocilizumab (n = 101) or placebo (n = 98). We performed RNA-sequencing on whole blood (n = 40) and T cells (n = 20). B and T cell subpopulations were examined by flow cytometry (n = 69).
FINDINGS


(i) STEMI patients had higher neutrophil counts at hospitalisation compared with stable angina patients. (ii) After percutaneous coronary intervention there was a gradual decline in neutrophils, which was significantly more pronounced in the tocilizumab group. (iii) The decrease in neutrophils in the tocilizumab group was associated with improved myocardial salvage and lower peak TnT. (iv) RNA-sequencing suggested that neutrophil function was also attenuated by tocilizumab. (v) B and T cell sub-populations changed only minimally after STEMI with minor effects of tocilizumab, supported as well by RNA-sequencing analyses of T cells. (vi) However, a low CD8 +  count was associated with improved myocardial salvage in patients admitted to the hospital > 3 h after symptom onset.
INTERPRETATION


Tocilizumab induced a rapid reduction in neutrophils and seemed to attenuate neutrophil function in STEMI patients potentially related to the beneficial effects of tocilizumab on myocardial salvage.
FUNDING


South-Eastern Norway Regional Health Authority (Nos. 2019067, 2017084), the Central Norway Regional Health Authority and Norwegian Research Council (No. 283867).",2022,The decrease in neutrophils in the tocilizumab group was associated with improved myocardial salvage and lower peak TnT. (iv) RNA-sequencing suggested that neutrophil function was also attenuated by tocilizumab.,['n\xa0=\xa0101) or'],"['placebo', 'Tocilizumab', 'tocilizumab']","['myocardial salvage', 'neutrophil counts', 'decrease in neutrophils', 'gradual decline in neutrophils', 'Interleukin-6 inhibition', 'neutrophil function']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.146627,The decrease in neutrophils in the tocilizumab group was associated with improved myocardial salvage and lower peak TnT. (iv) RNA-sequencing suggested that neutrophil function was also attenuated by tocilizumab.,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Huse', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne Kristine', 'Initials': 'AK', 'LastName': 'Anstensrud', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Annika E', 'Initials': 'AE', 'LastName': 'Michelsen', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; K. G. Jebsen Thrombosis Research and Expertise Centre (TREC), The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; K. G. Jebsen Cardiac Research Centre and Centre for Heart Failure Research, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Sindre', 'Initials': 'S', 'LastName': 'Woxholt', 'Affiliation': ""Clinic of Cardiology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.""}, {'ForeName': 'Kuan', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Ingvild Maria', 'Initials': 'IM', 'LastName': 'Tøllefsen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bendz', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Brage Høyem', 'Initials': 'BH', 'LastName': 'Amundsen', 'Affiliation': ""Clinic of Cardiology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.""}, {'ForeName': 'Jan Kristian', 'Initials': 'JK', 'LastName': 'Damås', 'Affiliation': 'Department of Infectious Disease, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Clinical and Molecular Medicine, Centre of Molecular Inflammation Research, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Erlend Sturle', 'Initials': 'ES', 'LastName': 'Berg', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Quiles-Jiménez', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Vigdis', 'Initials': 'V', 'LastName': 'Bjerkeli', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bendz', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Kleveland', 'Affiliation': ""Clinic of Cardiology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.""}, {'ForeName': 'Knut Haakon', 'Initials': 'KH', 'LastName': 'Stensaeth', 'Affiliation': ""Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Department of Radiology and Nuclear Medicine, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Opdahl', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Nils-Einar', 'Initials': 'NE', 'LastName': 'Kløw', 'Affiliation': 'Department of Radiology, Oslo University Hospital Ullevål, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Geir Øystein', 'Initials': 'GØ', 'LastName': 'Andersen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway; Department of Cardiology, Center for Clinical Heart Research, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': ""Clinic of Cardiology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.""}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Halvorsen', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; K. G. Jebsen Cardiac Research Centre and Centre for Heart Failure Research, University of Oslo, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Center for Clinical Heart Research, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Rheumatology, Dermatology and Infectious Disease, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Osnes', 'Affiliation': 'Department of Immunology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Tuva B', 'Initials': 'TB', 'LastName': 'Dahl', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Norway. Electronic address: tuvad@medisin.uio.no.'}]",EBioMedicine,['10.1016/j.ebiom.2022.104013']
918,35505658,"Lactobacillus rhamnosus  has no beneficial effect on anthropometric parameters, carbohydrate metabolism and androgen status in women with polycystic ovary syndrome.","The aim of this study was to assess the effect of a twenty-week weight-reducing diet with a low glycemic index and with or without  Lactobacillus rhamnosus  supplementation on changes in anthropometric, metabolic, and hormonal parameters in women with polycystic ovary syndrome (PCOS). The subjects were assigned to one of two intervention groups: the D group ( n  = 21) received a weight-reduction diet with a low glycemic index, and the DP group ( n  = 19) received a weight-reduction diet with a low glycemic index, as well as supplementation with  Lactobacillus rhamnosus . Anthropometric, metabolic, and hormonal parameters were evaluated at baseline and after twenty weeks of intervention. After twenty weeks, significant reductions in weight, body mass index, fat mass, and waist circumference were seen in both groups, but no significant differences between the groups were observed. The intervention resulted in changes in glucose assessment after two hours in oral glucose tolerance test and in insulin assessment after two hours in oral glucose tolerance test. In the D group, the testosterone level and free androgen index decreased significantly. In overweight and obese women with PCOS, probiotic supplementation taken alongside a twenty-week low-glycemic-index weight-reduction diet has no additional beneficial effects on anthropometrical parameters, carbohydrate metabolism, or androgen status, compared with the low-glycemic-index weight-reduction diet alone.",2022,"After twenty weeks, significant reductions in weight, body mass index, fat mass, and waist circumference were seen in both groups, but no significant differences between the groups were observed.","['women with polycystic ovary syndrome', 'women with polycystic ovary syndrome (PCOS']","['twenty-week weight-reducing diet with a low glycemic index and with or without  Lactobacillus rhamnosus  supplementation', 'weight-reduction diet with a low glycemic index, and the DP group ( n \u2009=\u200919) received a weight-reduction diet with a low glycemic index, as well as supplementation with  Lactobacillus rhamnosus ']","['weight, body mass index, fat mass, and waist circumference', 'testosterone level and free androgen index', 'changes in glucose assessment', 'Anthropometric, metabolic, and hormonal parameters', 'anthropometric parameters, carbohydrate metabolism and androgen status', 'anthropometric, metabolic, and hormonal parameters']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0302820', 'cui_str': 'Metabolism, Carbohydrate'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0303973,"After twenty weeks, significant reductions in weight, body mass index, fat mass, and waist circumference were seen in both groups, but no significant differences between the groups were observed.","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Łagowska', 'Affiliation': 'Department of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, Poland.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Kapczuk', 'Affiliation': 'Department of Perinatology and Gynecology, Division of Gynecology, Poznan University of Medical Sciences, Poznań, Poland.'}]",Women & health,['10.1080/03630242.2022.2072048']
919,35507334,Evaluation of Nomacopan for Treatment of Bullous Pemphigoid: A Phase 2a Nonrandomized Controlled Trial.,"Importance


Bullous pemphigoid is a difficult-to-treat autoimmune blistering skin disease that predominantly affects older adults and is associated with an increased mortality rate.
Objective


To examine the safety and therapeutic potential of nomacopan, an inhibitor of leukotriene B4 and complement C5, in patients with bullous pemphigoid.
Design, Setting, and Participants


This multicenter, single-group, phase 2a nonrandomized controlled trial was conducted in the dermatology departments of universities in the Netherlands and Germany. Participants were enrolled between September 2018 and April 2020. Older adult patients (aged ≥55 years) with mild to moderate, new-onset or relapsing bullous pemphigoid were recruited into the study.
Interventions


Patients received nomacopan, 90 mg, subcutaneously on day 1 and 30 mg subcutaneously daily until day 42.
Main Outcomes and Measures


The primary end point was the proportion of patients with grade 3 to 5 (severe) adverse events associated or possibly associated with nomacopan. Secondary end points included mean absolute and percentage changes in the Bullous Pemphigoid Disease Area Index (BPDAI) activity score, the BPDAI pruritus score, and the patient-reported outcome measures Dermatology Life Quality Index (DLQI) and Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL).
Results


A total of 9 patients (median [range] age, 75 [55-85] years) with bullous pemphigoid were included in the trial, of whom 5 were women (55.6%). No serious adverse events associated with nomacopan were found. The mean (90% CI) BPDAI activity score decreased from 32.0 (8.7) points on day 1 to 19.6 (9.0) points on day 42. Seven of 9 patients (77.8%) responded to nomacopan with a reduction in the BPDAI activity score of at least 8 points between days 1 and 42; in 3 responders, the reduction was 80% or greater. On day 42, the mean (90% CI) BPDAI pruritus score had decreased by 6.8 (4.6) points from 17.6 (4.0) points on day 1. The mean (90% CI) DLQI score decreased from 11.3 (4.2) points at baseline to 6.4 (3.8) points by day 42, and the mean (90% CI) TABQOL score decreased from 14.6 (5.4) points at baseline to 10.3 (5.0) points on day 42.
Conclusions and Relevance


Results of this nonrandomized controlled trial suggest that nomacopan can be well tolerated in older patients with bullous pemphigoid and may have therapeutic benefits for suppressing acute flares of this disease. A larger, placebo-controlled randomized clinical trial is warranted to confirm this safety profile and to establish nomacopan as a new therapeutic option for bullous pemphigoid.
Trial Registration


ClinicalTrials.gov Identifier: NCT04035733.",2022,"The mean (90% CI) DLQI score decreased from 11.3 (4.2) points at baseline to 6.4 (3.8) points by day 42, and the mean (90% CI)","['Bullous Pemphigoid', 'A total of 9 patients (median [range] age, 75 [55-85] years) with bullous pemphigoid were included in the trial, of whom 5 were women (55.6', 'Participants were enrolled between September 2018 and April 2020', 'patients with bullous pemphigoid', 'dermatology departments of universities in the Netherlands and Germany', 'Older adult patients (aged ≥55 years) with mild to moderate, new-onset or relapsing bullous pemphigoid were recruited into the study', 'older patients with bullous pemphigoid']","['placebo', 'nomacopan', 'Nomacopan']","['DLQI score', 'BPDAI activity score', 'mean absolute and percentage changes in the Bullous Pemphigoid Disease Area Index (BPDAI) activity score, the BPDAI pruritus score, and the patient-reported outcome measures Dermatology Life Quality Index (DLQI) and Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL', 'proportion of patients with grade 3 to 5 (severe) adverse events', 'TABQOL score', 'BPDAI pruritus score']","[{'cui': 'C0030805', 'cui_str': 'Bullous pemphigoid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0587461', 'cui_str': 'Dermatology department'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0030805', 'cui_str': 'Bullous pemphigoid'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0205405', 'cui_str': 'Bullous'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",5.0,0.337341,"The mean (90% CI) DLQI score decreased from 11.3 (4.2) points at baseline to 6.4 (3.8) points by day 42, and the mean (90% CI)","[{'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Sadik', 'Affiliation': 'Department of Dermatology, Allergy, and Venereology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Rashid', 'Affiliation': 'Department of Dermatology, Center of Blistering Diseases, European Reference Network-Skin, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Christoph M', 'Initials': 'CM', 'LastName': 'Hammers', 'Affiliation': 'Department of Dermatology, Allergy, and Venereology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Gilles F H', 'Initials': 'GFH', 'LastName': 'Diercks', 'Affiliation': 'Department of Dermatology, Center of Blistering Diseases, European Reference Network-Skin, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Weidinger', 'Affiliation': 'Department of Dermatology and Allergy, University of Kiel, Kiel, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Beissert', 'Affiliation': 'Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Schauer', 'Affiliation': 'Department of Dermatology, Medical Center-University of Freiburg, Faculty of Medicine, Freiburg, Germany.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fettiplace', 'Affiliation': 'Akari Therapeutics Plc, London, United Kingdom.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Center for Research on Inflammation of the Skin, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Yenting', 'Initials': 'Y', 'LastName': 'Ngai', 'Affiliation': 'Akari Therapeutics Plc, London, United Kingdom.'}, {'ForeName': 'Miles A', 'Initials': 'MA', 'LastName': 'Nunn', 'Affiliation': 'Akari Therapeutics Plc, London, United Kingdom.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Zillikens', 'Affiliation': 'Department of Dermatology, Allergy, and Venereology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Horváth', 'Affiliation': 'Department of Dermatology, Center of Blistering Diseases, European Reference Network-Skin, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}]",JAMA dermatology,['10.1001/jamadermatol.2022.1156']
920,35482348,Assessment of Toxic Effects and Survival in Treatment Deescalation With Radiotherapy vs Transoral Surgery for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: The ORATOR2 Phase 2 Randomized Clinical Trial.,"Importance


The optimal approach for treatment deescalation in human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs) is unknown.
Objective


To assess a primary radiotherapy (RT) approach vs a primary transoral surgical (TOS) approach in treatment deescalation for HPV-related OPSCC.
Design, Setting, and Participants


This international, multicenter, open-label parallel-group phase 2 randomized clinical trial was conducted at 9 tertiary academic cancer centers in Canada and Australia and enrolled patients with T1-T2N0-2 p16-positive OPSCC between February 13, 2018, and November 17, 2020. Patients had up to 3 years of follow-up.
Interventions


Primary RT (consisting of 60 Gy of RT with concurrent weekly cisplatin in node-positive patients) vs TOS and neck dissection (ND) (with adjuvant reduced-dose RT depending on pathologic findings).
Main Outcomes and Measures


The primary end point was overall survival (OS) compared with a historical control. Secondary end points included progression-free survival (PFS), quality of life, and toxic effects.
Results


Overall, 61 patients were randomized (30 [49.2%] in the RT arm and 31 [50.8%] in the TOS and ND arm; median [IQR] age, 61.9 [57.2-67.9] years; 8 women [13.6%] and 51 men [86.4%]; 31 [50.8%] never smoked). The trial began in February 2018, and accrual was halted in November 2020 because of excessive toxic effects in the TOS and ND arm. Median follow-up was 17 months (IQR, 15-20 months). For the OS end point, there were 3 death events, all in the TOS and ND arm, including the 2 treatment-related deaths (0.7 and 4.3 months after randomization, respectively) and 1 of myocardial infarction at 8.5 months. There were 4 events for the PFS end point, also all in the TOS and ND arm, which included the 3 mortality events and 1 local recurrence. Thus, the OS and PFS data remained immature. Grade 2 to 5 toxic effects occurred in 20 patients (67%) in the RT arm and 22 (71%) in the TOS and ND arm. Mean (SD) MD Anderson Dysphagia Inventory scores at 1 year were similar between arms (85.7 [15.6] and 84.7 [14.5], respectively).
Conclusions and Relevance


In this randomized clinical trial, TOS was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year. Long-term follow-up is required to assess OS and PFS outcomes.
Trial Registration


Clinicaltrials.gov Identifier: NCT03210103.",2022,Grade 2 to 5 toxic effects occurred in 20 patients (67%) in the RT arm and 22 (71%) in the TOS and ND arm.,"['9 tertiary academic cancer centers in Canada and Australia and enrolled patients with T1-T2N0-2 p16-positive OPSCC between February 13, 2018, and November 17, 2020', 'human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs', 'Patients had up to 3 years of follow-up', 'HPV-Associated Oropharyngeal Squamous Cell Carcinoma']","['Transoral Surgery', 'primary radiotherapy (RT) approach vs a primary transoral surgical (TOS) approach', 'cisplatin', 'TOS', 'Radiotherapy']","['progression-free survival (PFS), quality of life, and toxic effects', 'Grade 2 to 5 toxic effects', 'myocardial infarction', 'deaths', 'unacceptable risk of grade 5 toxic effects', 'mortality events and 1 local recurrence', 'Mean (SD) MD Anderson Dysphagia Inventory scores', 'good swallowing outcomes', 'overall survival (OS']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",61.0,0.33554,Grade 2 to 5 toxic effects occurred in 20 patients (67%) in the RT arm and 22 (71%) in the TOS and ND arm.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Prisman', 'Affiliation': 'Division of Otolaryngology - Head and Neck Surgery, Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Berthelet', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tran', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jonn', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Eskander', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Higgins', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Karam', 'Affiliation': 'Department of Radiation Oncology, Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Poon', 'Affiliation': 'Department of Radiation Oncology, Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Husain', 'Affiliation': 'Department of Radiation Oncology, Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Enepekides', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hier', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Sultanem', 'Affiliation': 'Department of Radiation Oncology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Richardson', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mlynarek', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Johnson-Obaseki', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Odell', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': 'Department of Radiation Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dowthwaite', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Jackson', 'Affiliation': 'Icon Cancer Centre, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Dzienis', 'Affiliation': 'Department of Medical Oncology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Neil"", 'Affiliation': 'Icon Cancer Centre, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Shamir', 'Initials': 'S', 'LastName': 'Chandarana', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Banerjee', 'Affiliation': 'Division of Radiation Oncology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jeffson', 'Initials': 'J', 'LastName': 'Chung', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, West Virginia University, Morgantown.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Tenenholtz', 'Affiliation': 'Department of Radiation Oncology, West Virginia University, Morgantown.'}, {'ForeName': 'Suren', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Hien', 'Initials': 'H', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Mendez', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winquist', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kuruvilla', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stewart', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Mitchell', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Department of Audiology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Bret', 'Initials': 'B', 'LastName': 'Wehrli', 'Affiliation': 'Department of Pathology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Kwan', 'Affiliation': 'Department of Pathology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Theurer', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jinka', 'Initials': 'J', 'LastName': 'Sathya', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'J Alex', 'Initials': 'JA', 'LastName': 'Hammond', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Varagur', 'Initials': 'V', 'LastName': 'Venkatesan', 'Affiliation': 'Division of Radiation Oncology, Department of Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'S Danielle', 'Initials': 'SD', 'LastName': 'MacNeil', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Nichols', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}]",JAMA oncology,['10.1001/jamaoncol.2022.0615']
921,35484528,Cognitive-behavioral group therapy in major depressive disorder with focus on self-esteem and optimism: an interventional study.,"BACKGROUND


Major depressive disorder is a common psychological condition that can lead to negative individual and social consequences, the management of which is very important in treating the patients. The present study aimed to determine the effect of cognitive-behavioral group therapy on self-esteem and optimism in patients with major depressive disorder.
METHODS


This is a single-blinded, randomized controlled trial in which a total of 64 patients with major depressive disorder were recruited using convenience sampling and then randomly assigned to two groups of Cognitive-Behavioral Group Therapy (CBGT) and Treatment-As-Usual (TAU). Data collection tools consisted of a demographic questionnaire, the Rosenberg Self-Esteem Scale (RSES), and the Revised Life Orientation Test (LOT-R). In the pretest stage, participants in both groups completed the above questionnaires before the intervention. Patients in the CBGT group received eight 90-min sessions of cognitive-behavioral therapy during four weeks (two sessions a week). Then participants re-completed RSES and LOT-R immediately, three months, and six months after the intervention. Data were analyzed with SPSS software version 16.0 using chi-squared test, independent-samples t-test, and repeated measures Analysis of Variance. The significance level (p-value) was considered to be less than 0.05.
RESULTS


It was indicated that there was a statistically significant difference in the mean scores of self-esteem and optimism between the two groups immediately, three months, and six months after the intervention (p < .05). The mean scores of self-esteem and optimism in the CBGT group increased significantly after the intervention compared to before it, although these scores gradually decreased over the three measurement time points after the intervention.
CONCLUSIONS


Based upon the results, it was concluded that the level of optimism and self-esteem increased significantly in the CBGT group after the intervention, although the levels of the above variables dropped again in the long run after the intervention due to the discontinuity of CBGT sessions. Therefore, it is necessary to take particular measures to regularly hold the sessions of CBGT for patients with major depressive disorder.
TRIAL REGISTRATION NUMBER


IRCT20140212016564N15 , The date of registration: 20-09-2021, Retrospectively registered.",2022,"The mean scores of self-esteem and optimism in the CBGT group increased significantly after the intervention compared to before it, although these scores gradually decreased over the three measurement time points after the intervention.
","['patients with major depressive disorder', '64 patients with major depressive disorder']","['cognitive-behavioral therapy', 'cognitive-behavioral group therapy', 'CBGT', 'Cognitive-behavioral group therapy', 'Cognitive-Behavioral Group Therapy (CBGT) and Treatment-As-Usual (TAU']","['mean scores of self-esteem and optimism', 'level of optimism and self-esteem', 'self-esteem and optimism', 'Rosenberg Self-Esteem Scale (RSES']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}]",64.0,0.0195806,"The mean scores of self-esteem and optimism in the CBGT group increased significantly after the intervention compared to before it, although these scores gradually decreased over the three measurement time points after the intervention.
","[{'ForeName': 'Radfar', 'Initials': 'R', 'LastName': 'Moloud', 'Affiliation': 'Department of Psychiatric Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Pardis Nazlou. 11 Km of Nazlou Road, Urmia, Iran. radfar.m@umsu.ac.ir.'}, {'ForeName': 'Yavari', 'Initials': 'Y', 'LastName': 'Saeed', 'Affiliation': 'Department of Psychiatric Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Pardis Nazlou. 11 Km of Nazlou Road, Urmia, Iran.'}, {'ForeName': 'Haghighi', 'Initials': 'H', 'LastName': 'Mahmonir', 'Affiliation': 'Department of Psychiatry, School of Medicine, Razi Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Gharaaghaji Asl', 'Initials': 'GA', 'LastName': 'Rasool', 'Affiliation': 'Department of Community Medicine, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}]",BMC psychiatry,['10.1186/s12888-022-03918-y']
922,35486027,Comparison between application of platelet rich plasma and mucosal advancement flap in patients with high transsphincteric anal fistulas: a randomized control trial.,"BACKGROUND


There is still a search for a standard method of therapy for high anal fistulas. The aim of this trial was a comparison between a modified two stage minimally invasive procedure, consisting of loose-seton placement with the subsequent application of platelet rich plasma with mucosal advancement flap for the treatment of high transsphincteric anal fistulas of crypto-glandular origin.
METHODS


The study was designed as a prospective, randomized trial including 96 patients. Curettage of fistulous tracts, and loose-seton placement was performed in those patients with active inflammation, and if the diameter of a fistulous tract exceeded 3 mm. Afterwards, the patients were randomly assigned to either the PRP group or MAF group, consisting of 49 patients, and 47 patients, respectively.
RESULTS


There was no significant statistical difference (p = 0.152) between both investigated groups of patients regarding closure of fistulas since it was achieved in 35 (71.43%) patients from group I, compared to 27 (57.45%) patients from group II. The diameter of fistulous tracts below 4 mm exerted a significant impact (p < 0.001) on the healing process after PRP application because fistulas with the narrow tracts were closed in 34 (87.18%) patients, whereas a wider fistula was healed in 1 (10%) patient.
CONCLUSION


The local application of PRP in high, unbranched, and with narrow tracts trans-sphincteric anal fistulas of crypto-glandular origin, following loose-seton drainage is an effective, simple, and a safe method of therapy with a low rate of morbidity.",2022,"There was no significant statistical difference (p = 0.152) between both investigated groups of patients regarding closure of fistulas since it was achieved in 35 (71.43%) patients from group I, compared to 27 (57.45%) patients from group II.","['patients with high transsphincteric anal fistulas', 'high anal fistulas', '96 patients', 'high transsphincteric anal fistulas of crypto-glandular origin']","['platelet rich plasma and mucosal advancement flap', 'Curettage of fistulous tracts, and loose-seton placement', 'PRP group or MAF', 'loose-seton placement with the subsequent application of platelet rich plasma with mucosal advancement flap']","['diameter of fistulous tracts', 'healing process', 'closure of fistulas since it']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0267571', 'cui_str': 'Transsphincteric anal fistula'}, {'cui': 'C0348083', 'cui_str': 'High anal fistula'}, {'cui': 'C0010416', 'cui_str': 'Cryptococcus neoformans'}, {'cui': 'C0225353', 'cui_str': 'Glandular'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0973297', 'cui_str': 'Seton placement'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079786', 'cui_str': 'Macrophage activating factor'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",96.0,0.0120929,"There was no significant statistical difference (p = 0.152) between both investigated groups of patients regarding closure of fistulas since it was achieved in 35 (71.43%) patients from group I, compared to 27 (57.45%) patients from group II.","[{'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Hermann', 'Affiliation': 'Department of General, and Endocrine Surgery, and Gastroenterologic Oncology, Poznań University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Cwaliński', 'Affiliation': 'Department of General, and Endocrine Surgery, and Gastroenterologic Oncology, Poznań University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Banasiewicz', 'Affiliation': 'Department of General, and Endocrine Surgery, and Gastroenterologic Oncology, Poznań University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kołodziejczak', 'Affiliation': 'Faculty of Mathematics and Computer Science, Adam Mickiewicz University, Poznań, Poland.'}]",ANZ journal of surgery,['10.1111/ans.17656']
923,34882890,Deep Learning Assisted Diagnosis of Musculoskeletal Tumors Based on Contrast-Enhanced Magnetic Resonance Imaging.,"BACKGROUND


Misdiagnosis of malignant musculoskeletal tumors may lead to the delay of intervention, resulting in amputation or death.
PURPOSE


To improve the diagnostic efficacy of musculoskeletal tumors by developing deep learning (DL) models based on contrast-enhanced magnetic resonance imaging and to quantify the improvement in diagnostic performance obtained by using these models.
STUDY TYPE


Retrospective.
POPULATION


Three hundreds and four musculoskeletal tumors, including 212 malignant and 92 benign lesions, were randomized into the training (n = 180), validation (n = 62) and testing cohort (n = 62).
FIELD STRENGTH/SEQUENCE


A 3 T/T 1  -weighted (T 1  -w), T 2  -weighted (T 2  -w), diffusion-weighted imaging (DWI), and contrast-enhanced T1-weighted (CET 1  -w) images.
ASSESSMENT


Three DL models based, respectively, on the sagittal, coronal, and axial MR images were constructed to predict the malignancy of tumors. Blinded to the prediction results, a group of specialists made independent initial diagnoses for each patient by reading all image sequences. One month after the initial diagnoses, the same group of doctors made another round of diagnoses knowing the malignancy of each tumor predicted by the three models. The reference standard was the pathological diagnosis of malignancy.
STATISTICAL TESTS


Sensitivity, specificity, and accuracy (all with 95% confidential intervals [CI]) corresponding to each diagnostic test were computed. Chi-square tests were used to assess the differences in those parameters with and without DL models. A P value < 0.05 was considered statistically significant.
RESULTS


The developed models significantly improved the diagnostic sensitivities of two oncologists by 0.15 (95% CI: 0.06-0.24) and 0.36 (95% CI: 0.24-0.28), one radiologist by 0.12 (95% CI: 0.04-0.20), and three of the four orthopedists, respectively, by 0.12 (95% CI: 0.04-0.20), 0.29 (95% CI: 0.18-0.40), and 0.23 (95% CI: 0.13-0.33), without impairing any of their diagnostic specificities (all P > 0.128).
DATA CONCLUSION


The DL models developed can significantly improve the performance of doctors with different training and experience in diagnosing musculoskeletal tumors.
EVIDENCE LEVEL


3 TECHNICAL EFFICACY: Stage 2.",2022,"The developed models significantly improved the diagnostic sensitivities of two oncologists by 0.15 (95% CI: 0.06-0.24) and 0.36 (95% CI: 0.24-0.28), one radiologist by 0.12 (95% CI: 0.04-0.20), and three of the four orthopedists, respectively, by 0.12 (95% CI: 0.04-0.20), 0.29 (95% CI: 0.18-0.40), and 0.23 (95% CI: 0.13-0.33), without impairing any of their diagnostic specificities (all P > 0.128).
","['Three hundreds and four musculoskeletal tumors, including 212 malignant and 92 benign lesions']",[],['diagnostic sensitivities'],"[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",212.0,0.112635,"The developed models significantly improved the diagnostic sensitivities of two oncologists by 0.15 (95% CI: 0.06-0.24) and 0.36 (95% CI: 0.24-0.28), one radiologist by 0.12 (95% CI: 0.04-0.20), and three of the four orthopedists, respectively, by 0.12 (95% CI: 0.04-0.20), 0.29 (95% CI: 0.18-0.40), and 0.23 (95% CI: 0.13-0.33), without impairing any of their diagnostic specificities (all P > 0.128).
","[{'ForeName': 'Keyang', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, 200233, China.""}, {'ForeName': 'Mingzi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Aitrox Technology Corporation Limited, Shanghai, China.'}, {'ForeName': 'Zhaozhi', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Department of Computer Science and Engineering, Shanghai Jiao Tong University, Shanghai, 200233, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, 200233, China.""}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, 200233, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liao', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, 200233, China.""}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Computer Science and Engineering, Shanghai Jiao Tong University, Shanghai, 200233, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'MoE Key Lab of Artificial Intelligence, AI Institute, Shanghai Jiao Tong University, Shanghai, 200233, China.'}, {'ForeName': 'Chicheng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Shanghai Aitrox Technology Corporation Limited, Shanghai, China.'}, {'ForeName': 'Haoyang', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Shanghai Aitrox Technology Corporation Limited, Shanghai, China.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Shanghai Aitrox Technology Corporation Limited, Shanghai, China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, 200233, China.""}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.28025']
924,35488222,Effects of aerobic exercise on quality of life of people with HIV-associated neurocognitive disorder on antiretroviral therapy: a randomised controlled trial.,"BACKGROUND


HIV-associated neurocognitive disorder (HAND) negatively impacts quality of life (QoL) of people living with HIV who are on antiretroviral therapy (ART). Behavioural intervention adjunct to ART may improve QoL of people with HAND. We determine the effect of a 12-week aerobic exercise programme on QoL in people with HAND who were receiving ART.
TRIAL DESIGN


This was a parallel-group, randomised controlled trial with concealed allocation and intention-to-treat analysis.
METHODS


We identified 73 participants diagnosed with HAND. Participants were sampled from an earlier study that examined the prevalence of HAND according to the Frascati criteria. Participants were randomised and allocated to an intervention of 12-weeks of aerobic exercise, comprising three 20-60 min sessions per week of moderate-intensity aerobic exercise using a cycle ergometer. The primary outcome was QoL, which was evaluated using the World Health Quality of Life Questionnaire (WHOQoL)-BREF.
RESULTS


Participants in the exercise (n = 39) and control (n = 35) groups had similar sociodemographic characteristics (p > 0.05). Following the 12-week aerobic exercise programme, participants in the exercise group had improved physical (p < 0.001), psychological (p = 0.008) and environmental (p = 0.001) domains of the QoL (p = 0.001) and overall QoL (p = 0.001) relative to the control group. Similarly, participants in the exercise group had lower depression scores than participants in the control group. Depression scores in the exercise group were still lower 3 months post-intervention (p = 0.007). Only the improvements in physical (p = 0.02) and psychological (p = 0.007) domains of QoL were sustained at 3 months post-intervention.
CONCLUSIONS


Aerobic exercise improves the QoL of people with HAND. To ensure sustained benefits, people with HAND may need to engage in long-term physical exercise. Trial registration The trial is registered with the PAN African Trial Registry (PACTR). Date: 01/09/2020, ID: PACTR202009483415745.",2022,"Only the improvements in physical (p = 0.02) and psychological (p = 0.007) domains of QoL were sustained at 3 months post-intervention.
","['people living with HIV who are on antiretroviral therapy (ART', 'people with HIV-associated neurocognitive disorder on antiretroviral therapy', 'people with HAND who were receiving ART', '73 participants diagnosed with HAND']","['Aerobic exercise', 'aerobic exercise', 'Behavioural intervention adjunct to ART', 'moderate-intensity aerobic exercise using a cycle ergometer', 'aerobic exercise programme']","['World Health Quality of Life Questionnaire (WHOQoL)-BREF', 'quality of life', 'QoL of people with HAND', 'lower depression scores', 'overall QoL', 'sociodemographic characteristics', 'Depression scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0043236', 'cui_str': 'Worldwide Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",73.0,0.183548,"Only the improvements in physical (p = 0.02) and psychological (p = 0.007) domains of QoL were sustained at 3 months post-intervention.
","[{'ForeName': 'Martins', 'Initials': 'M', 'LastName': 'Nweke', 'Affiliation': 'Department of Physiotherapy, School of Healthcare Sciences, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa. martins.nweke@gmail.com.'}, {'ForeName': 'Nombeko', 'Initials': 'N', 'LastName': 'Mshunqane', 'Affiliation': 'Department of Physiotherapy, School of Healthcare Sciences, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Govender', 'Affiliation': 'Department of Basic Medical Sciences, Durban University of Technology, Durban, South Africa.'}, {'ForeName': 'Aderonke O', 'Initials': 'AO', 'LastName': 'Akinpelu', 'Affiliation': 'Department of Physiotherapy, Faculty of Clinical Sciences, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Adesola', 'Initials': 'A', 'LastName': 'Ogunniyi', 'Affiliation': 'Department of Medicine, Faculty of Clinical Sciences, University of Ibadan, Ibadan, Nigeria.'}]",BMC infectious diseases,['10.1186/s12879-022-07389-0']
925,35488213,"Combined effects of virtual reality techniques and motor imagery on balance, motor function and activities of daily living in patients with Parkinson's disease: a randomized controlled trial.","BACKGROUND


Parkinson's disease (PD) is the second most prevalent neurodegenerative disorder, impairing balance and motor function. Virtual reality (VR) and motor imagery (MI) are emerging techniques for rehabilitating people with PD. VR and MI combination have not been studied in PD patients. This study was conducted to investigate the combined effects of VR and MI techniques on the balance, motor function, and activities of daily living (ADLs) of patients with PD.
METHODS


This study was a single-centered, two-armed, parallel-designed randomized controlled trial. A total of 44 patients of either gender who had idiopathic PD were randomly allocated into two groups using lottery methods. Both groups received Physical therapy (PT) treatment, while the experimental group (N: 20) received VR and MI in addition to PT. Both groups received assigned treatment for three days a week on alternate days for 12 weeks. The Unified Parkinson's Disease Rating Scale (UPDRS) (parts II and III), Berg Balance Scale (BBS), and Activities-specific Balance Confidence (ABC) Scale were used as outcome measures for motor function, balance, and ADLs. The baseline, 6 th , and 12 th  weeks of treatment were assessed, with a 16 th  week follow-up to measure retention. The data was analysed using SPSS 24.
RESULTS


The experimental group showed significant improvement in motor function than the control group on the UPDRS part III, with 32.45±3.98 vs. 31.86±4.62 before and 15.05±7.16 vs. 25.52±7.36 at 12-weeks, and a p-value < 0.001. At 12 weeks, the experimental group's BBS scores improved from 38.95±3.23 to 51.36±2.83, with p-value < 0.001. At 12 weeks, the experimental group's balance confidence improved considerably, from 59.26±5.87to 81.01±6.14, with a p-value of < 0.001. The experimental group's ADL scores improved as well, going from 22.00±4.64 to 13.07±4.005 after 12 weeks, with a p-value of < 0.001.
CONCLUSION


VR with MI techniques in addition to routine PT significantly improved motor function, balance, and ADLs in PD patients compared to PT alone.
TRIAL REGISTRATION


IRCT20200221046567N1 . Date of registration: 01/04/2020.",2022,"At 12 weeks, the experimental group's BBS scores improved from 38.95±3.23 to 51.36±2.83, with p-value < 0.001.","['rehabilitating people with PD', '44 patients of either gender who had idiopathic PD', 'patients with PD', 'PD patients', ""patients with Parkinson's disease""]","['VR and MI techniques', 'Virtual reality (VR) and motor imagery (MI', 'VR and MI in addition to PT', 'virtual reality techniques and motor imagery', 'Physical therapy (PT']","[""Unified Parkinson's Disease Rating Scale (UPDRS) (parts II and III), Berg Balance Scale (BBS), and Activities-specific Balance Confidence (ABC) Scale"", 'ADL scores', 'BBS scores', 'motor function, balance, and ADLs', 'balance, motor function and activities of daily living', 'balance confidence', 'balance, motor function, and activities of daily living (ADLs', 'motor function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0454046', 'cui_str': 'Imagery technique'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",44.0,0.0989078,"At 12 weeks, the experimental group's BBS scores improved from 38.95±3.23 to 51.36±2.83, with p-value < 0.001.","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Kashif', 'Affiliation': 'University Institute of Physical Therapy, Faculty of Allied Health Sciences, University of Lahore, 1 KM Defence Road, Lahore, 4200, Pakistan. kashif.shaffi@gmail.com.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'University Institute of Physical Therapy, Faculty of Allied Health Sciences, University of Lahore, 1 KM Defence Road, Lahore, 4200, Pakistan.'}, {'ForeName': 'Muhammad Ali Mohseni', 'Initials': 'MAM', 'LastName': 'Bandpei', 'Affiliation': 'University Institute of Physical Therapy, Faculty of Allied Health Sciences, University of Lahore, 1 KM Defence Road, Lahore, 4200, Pakistan.'}, {'ForeName': 'Syed Amir', 'Initials': 'SA', 'LastName': 'Gilani', 'Affiliation': 'University Institute of Physical Therapy, Faculty of Allied Health Sciences, University of Lahore, 1 KM Defence Road, Lahore, 4200, Pakistan.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Hanif', 'Affiliation': 'University Institute of Physical Therapy, Faculty of Allied Health Sciences, University of Lahore, 1 KM Defence Road, Lahore, 4200, Pakistan.'}, {'ForeName': 'Humaira', 'Initials': 'H', 'LastName': 'Iram', 'Affiliation': 'Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University, Faisalabad Campus, Faisalabad, Pakistan.'}]",BMC geriatrics,['10.1186/s12877-022-03035-1']
926,35489133,"Blood pressure, antihypertensive drugs, and incident frailty: The Multidomain Alzheimer Preventive Trial (MAPT).","OBJECTIVES


To examine the association of (1) high and low blood pressure (BP) and (2) antihypertensive (AH) drug use with incident frailty.
STUDY DESIGN


We conducted a secondary analysis of data from the Multidomain Alzheimer Preventive Trial (MAPT), in which 1394 non-frail community-dwelling participants aged ≥70 years were followed up for 5 years. BP was measured once at baseline in a lying position using a validated electronic device. High BP was defined as systolic BP ≥ 140 mm Hg and/or diastolic BP ≥ 90 mm Hg, and low BP as systolic BP ≤ 110 mm Hg and/or diastolic BP ≤ 70 mm Hg. AH drugs were assessed at baseline and classified according to the Anatomical Therapeutic Chemical (ATC) code.
MAIN OUTCOME MEASURES


Incident frailty over the 5 years was assessed using the Fried phenotype. Cox proportional hazards models were used for the analyses.
RESULTS


Low BP was associated with a greater risk of frailty (HR = 1.43, 95% CI [1.07-1.92], p = 0.02) after adjustment for age, sex, education, AH drug use, BMI, diabetes, ischemic heart disease, congestive heart failure, AF, stroke, MAPT randomization group, sit-to-stand chair test and pre-frailty. Participants with low BP and those on two or more AH drugs were at the greatest risk of frailty. Neither high BP (HR = 0.84, 95% CI [0.63-1.22], p = 0.24) nor AH drug use (HR = 1.21, 95% CI [0.89-1.64], p = 0.22) was independently associated with incident frailty.
CONCLUSIONS


Low BP could be used as a new marker for identifying older adults at higher risk of frailty.
CLINICALTRIALS


gov registration number: NCT00672685.",2022,"RESULTS


Low BP was associated with a greater risk of frailty (HR = 1.43, 95% CI [1.07-1.92], p = 0.02) after adjustment for age, sex, education, AH drug use, BMI, diabetes, ischemic heart disease, congestive heart failure, AF, stroke, MAPT randomization group, sit-to-stand chair test and pre-frailty.","['110\xa0mm', '1394 non-frail community-dwelling participants aged ≥70\xa0years', 'Participants with low BP and those on two or more AH drugs', '140\xa0mm']",['Multidomain Alzheimer Preventive Trial (MAPT'],"['BP', 'low BP as systolic BP\xa0≤', 'systolic BP\xa0≥', 'Blood pressure, antihypertensive drugs, and incident frailty', 'Hg and/or diastolic BP', 'Hg and/or diastolic BP\xa0≥', 'risk of frailty', 'High BP', 'association of (1) high and low blood pressure (BP) and (2) antihypertensive (AH']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205250', 'cui_str': 'High'}]",1394.0,0.206659,"RESULTS


Low BP was associated with a greater risk of frailty (HR = 1.43, 95% CI [1.07-1.92], p = 0.02) after adjustment for age, sex, education, AH drug use, BMI, diabetes, ischemic heart disease, congestive heart failure, AF, stroke, MAPT randomization group, sit-to-stand chair test and pre-frailty.","[{'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Rouch', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France; UMR INSERM 1295, Université Toulouse III, France. Electronic address: rouch.l@chu-toulouse.fr.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France; UMR INSERM 1295, Université Toulouse III, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hanon', 'Affiliation': 'EA 4468, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Service de gériatrie, Hôpital Broca, AP-HP, Hôpitaux Universitaires Paris Centre, Paris, France.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Vidal', 'Affiliation': 'EA 4468, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Service de gériatrie, Hôpital Broca, AP-HP, Hôpitaux Universitaires Paris Centre, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cestac', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France; UMR INSERM 1295, Université Toulouse III, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Sallerin', 'Affiliation': 'Unité INSERM 1048, Université Toulouse III, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'UMR INSERM 1295, Université Toulouse III, France; Epidemiology and Public Health Department, CHU de Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France; UMR INSERM 1295, Université Toulouse III, France.'}, {'ForeName': 'Philipe De Souto', 'Initials': 'PS', 'LastName': 'Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, CHU de Toulouse, France; UMR INSERM 1295, Université Toulouse III, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Maturitas,['10.1016/j.maturitas.2022.03.001']
927,35489112,"A mini-flipped, game-based Mediterranean diet learning program on dietary behavior and cognitive function among community-dwelling older adults in Taiwan: A cluster-randomized controlled trial.","The Mediterranean diet has been recommended to delay cognitive decline, but adherence to the diet among older adults remain poor, and research on interventions that effectively promote the diet has been inconclusive. This study examined the effects of a mini-flipped, game-based Mediterranean diet learning program in improving dietary behavior and cognitive function in community-dwelling older adults in Taiwan. A cluster randomized controlled trial was conducted. The experimental group completed an 8-week, mini-flipped, game-based learning program. Data were collected at baseline and 8 weeks after intervention. Outcome measures included dietary behavior, global cognitive function, and subjective cognitive dysfunction. Compared with the control group, the experimental group exhibited significantly improved Mediterranean diet behavior and global cognitive function after the intervention, although there was no significant difference in subjective cognitive function. Future research should be conducted with larger populations and longer-term follow-up to evaluate the effect of this learning program.",2022,"Compared with the control group, the experimental group exhibited significantly improved Mediterranean diet behavior and global cognitive function after the intervention, although there was no significant difference in subjective cognitive function.",['community-dwelling older adults in Taiwan'],"['mini-flipped, game-based learning program', 'mini-flipped, game-based Mediterranean diet learning program']","['Mediterranean diet behavior and global cognitive function', 'subjective cognitive function', 'dietary behavior, global cognitive function, and subjective cognitive dysfunction', 'dietary behavior and cognitive function']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086858', 'cui_str': 'Programmed Learning'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",,0.0126522,"Compared with the control group, the experimental group exhibited significantly improved Mediterranean diet behavior and global cognitive function after the intervention, although there was no significant difference in subjective cognitive function.","[{'ForeName': 'Cheng-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Institute of Community Health Care, College of Nursing, National Yang Ming Chiao Tung University, Taipei, Taiwan. Electronic address: ccchou@nycu.edu.tw.'}, {'ForeName': 'Yu-Jen', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Institute of Community Health Care, College of Nursing, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Chi-Jane', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Li-Ching', 'Initials': 'LC', 'LastName': 'Lyu', 'Affiliation': 'Graduate Programs of Nutrition Science, National Taiwan Normal University, Taipei, Taiwan.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.03.009']
928,35489100,Early aerobic exercise among adolescents at moderate/high risk for persistent post-concussion symptoms: A pilot randomized clinical trial.,"PURPOSE


To determine the proportion of adolescents at moderate/high risk for Persistent Postconcussion Symptoms (PPCS) who develop PPCS when randomized to early aerobic exercise or standard-of-care and examine exercise volume/intensity between groups.
METHODS


Using a randomized clinical trial design, we enrolled patients 10-18 years of age who obtained a ""Predicting/Preventing Postconcussive Problems in Pediatrics"" (5P) risk score ≥6 and enrolled/tested ≤ one-week post-concussion (mean = 5.5 ± 1.5 days post-concussion). Participants were randomized to ""Exercise"" (5 days/week, 20 min/day aerobic exercise at individualized intensity [80% HR at exercise test cessation]) or ""Standard-of-Care"" (no exercise recommendations). They returned for re-testing one-month post-concussion, and we remotely monitored exercise between assessments.
RESULTS


Sixteen participants enrolled (intervention: n = 9, 56% female, 14.2 ± 2.1 years; standard-of-care: n = 7, 57% female, 13.6 ± 1.7 years). A smaller proportion of the early aerobic exercise group developed PPCS when compared to the standard-of-care group (44% vs. 86%; relative risk = 0.52; 95% confidence interval = 0.34-1.36; number-needed-to-treat = 2.4).
CONCLUSION


We observed that participants randomized to early aerobic exercise had a lower risk of PPCS compared to standard-of-care. Although not statistically significant, these results suggest early/individualized aerobic exercise among those at moderate/high PPCS risk may be effective at reducing that risk, and early aerobic exercise is not detrimental to recovery outcomes.",2022,We observed that participants randomized to early aerobic exercise had a lower risk of PPCS compared to standard-of-care.,"['Sixteen participants enrolled (intervention: n\xa0=\xa09, 56% female, 14.2\xa0±\xa02.1 years; standard-of-care: n\xa0=\xa07, 57% female, 13.6\xa0±\xa01.7 years', 'adolescents at moderate/high risk for persistent post-concussion symptoms', 'adolescents at moderate/high risk for Persistent Postconcussion Symptoms (PPCS) who develop PPCS', 'enrolled patients 10-18 years of age who obtained a ""Predicting/Preventing Postconcussive Problems in Pediatrics"" (5P) risk score ≥6 and enrolled/tested\xa0≤\xa0one-week post-concussion (mean\xa0=\xa05.5\xa0±\xa01.5 days post-concussion']","['Early aerobic exercise', 'aerobic exercise', 'early aerobic exercise or standard-of-care and examine exercise volume/intensity between groups', 'Exercise"" (5 days/week, 20\xa0min/day aerobic exercise at individualized intensity [80% HR at exercise test cessation]) or ""Standard-of-Care"" (no exercise recommendations']","['PPCS', 'risk of PPCS']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",16.0,0.110534,We observed that participants randomized to early aerobic exercise had a lower risk of PPCS compared to standard-of-care.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Howell', 'Affiliation': ""Sports Medicine Center, Children's Hospital Colorado, CO, USA; Department of Orthopedics, University of Colorado School of Medicine, CO, USA. Electronic address: David.Howell@CUAnschutz.edu.""}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Wingerson', 'Affiliation': ""Sports Medicine Center, Children's Hospital Colorado, CO, USA; Department of Rehabilitation Medicine, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Kirkwood', 'Affiliation': ""Department of Rehabilitation Medicine, Children's Hospital Colorado, Aurora, CO, USA; Department of Physical Medicine& Rehabilitation, University of Colorado School of Medicine, Aurora, CO, USA.""}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Grubenhoff', 'Affiliation': ""Section of Pediatric Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA; Emergency Department, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Wilson', 'Affiliation': ""Sports Medicine Center, Children's Hospital Colorado, CO, USA; Department of Orthopedics, University of Colorado School of Medicine, CO, USA; Department of Pediatrics, University of Colorado School of Medicine, CO, USA.""}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2022.04.010']
929,35490873,Assessing race and ethnicity differences in outcomes based on GDMT and target NT-proBNP in patients with heart failure with reduced ejection fraction: An analysis of the GUIDE-IT study.,"BACKGROUND


The GUIDE-IT trial was, a multicenter, randomized, parallel group, unblinded study that randomized patients to having heart failure therapy titrated to achieve an NT-proBNP <1000 pg/mL or to usual clinical care.
METHODS AND RESULTS


We performed pre-specified subgroup analysis to look for the race and ethnicity-based differences in clinical outcomes of patients who were able to achieve GDMT or target NT-proBNP concentration of ≤1000 pg/mL at 90 days of follow-up. There were 894 patients enrolled in GUIDE-IT study. Of these, 733 participants had available data on 90-day guideline directed triple therapy and 616 on NT-proBNP. 35% of the patients were Black and 6% were Hispanic. Black patients were younger, had more comorbidities, lower EF, and higher NYHA class compared with non-Black. Adjusting for 90-day NT-proBNP and important baseline covariates, Black patients were at a higher risk than non-Black patients for HF hospitalization [HR, 2.19; 95% CI, 1.51-3.17; p < 0.0001], but at a similar risk for mortality [HR, 0.85.; 95% CI, 0.44-1.66; p = 0.64]. Similar results were seen adjusting for 90-day GDMT [HF hospitalization: Black vs non-Black, HR: 1.97; 1.41-2.77, P < 0.0001; mortality: HR: 0.70; 0.39-1.26, p = 0.23]. There were no significant differences between Hispanic and non-Hispanic patients with respect to heart failure hospitalization, cardiovascular or all-cause mortality. Over the study period, Black and Hispanic patients experienced smaller changes in physical function and quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall score.
CONCLUSION


Compared to non-Black patients, Black patients in GUIDE-IT study had a higher risk of heart failure hospitalization, but a comparable risk of mortality, despite improved use of GDMT and achievement of similar biomarker targets.",2022,"There were no significant differences between Hispanic and non-Hispanic patients with respect to heart failure hospitalization, cardiovascular or all-cause mortality.","['894 patients enrolled in GUIDE-IT study', 'patients with heart failure with reduced ejection fraction', 'patients who were able to achieve GDMT or target NT-proBNP concentration of ≤1000\u202fpg/mL at 90\u202fdays of follow-up', '733 participants had available data on 90-day guideline directed triple therapy and 616 on NT-proBNP', 'randomized patients to having heart failure therapy titrated to achieve an', 'Black patients']","['GDMT and target NT-proBNP', 'NT-proBNP']","['physical function and quality of life', '90-day GDMT [HF hospitalization: Black vs non-Black, HR', 'heart failure hospitalization, cardiovascular or all-cause mortality', 'Kansas City Cardiomyopathy Questionnaire overall score', 'heart failure hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",894.0,0.132118,"There were no significant differences between Hispanic and non-Hispanic patients with respect to heart failure hospitalization, cardiovascular or all-cause mortality.","[{'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Pahuja', 'Affiliation': 'Medstar Georgetown University/Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'Office of Biostatistics Research, National Heart, Lung, and Blood Institute, Bethesda, MD, United States of America.'}, {'ForeName': 'John-Ross D', 'Initials': 'JD', 'LastName': 'Clarke', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Daubert', 'Affiliation': 'Duke University Medical Center, Durham, NC, United States of America; Duke Clinical Research Institute, Durham, NC, United States of America.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke University Medical Center, Durham, NC, United States of America; Duke Clinical Research Institute, Durham, NC, United States of America.'}, {'ForeName': 'Lawton', 'Initials': 'L', 'LastName': 'Cooper', 'Affiliation': 'National Heart, Lung and Blood Institute, Bethesda, MD, United States of America.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung and Blood Institute, Bethesda, MD, United States of America.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Kirkwood', 'Initials': 'K', 'LastName': 'Adams', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, United States of America.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke University Medical Center, Durham, NC, United States of America; Duke Clinical Research Institute, Durham, NC, United States of America.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Central Michigan University, Midlands, MI, United States of America. Electronic address: Ilppina@aol.com.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2022.04.010']
930,35500460,Durvalumab with chemoradiotherapy for limited-stage small-cell lung cancer.,"BACKGROUND


The current standard treatment for limited-stage small-cell lung cancer (LS-SCLC) is chemotherapy with concurrent chemoradiotherapy (CCRT).
METHODS


In this single-arm phase II study, patients with LS-SCLC received four cycles of etoposide, cisplatin, and durvalumab every 3 weeks. Thoracic radiotherapy of 52.5 Gy in 25 once-daily fractions was started with the third cycle of chemoimmunotherapy. After CCRT plus durvalumab, patients received durvalumab consolidation therapy every 4 weeks for a maximum of 2 years after study enrolment. Prophylactic cranial irradiation (PCI) was recommended.
RESULTS


Fifty-one patients were enrolled, and 50 were included in the full analysis set. With the median follow-up duration of 26.6 months, the median PFS was 14.4 months (95% confidence interval: 10.3-NA), and the 24-month PFS rate was 42.0%. The median overall survival was not reached with a 24-month overall survival rate of 67.8%. The positive PD-L1 group (n = 22) was not associated with longer PFS (hazard ratio, 0.70; 0.31-1.58) and overall survival (0.64; 0.22-1.84) compared with the negative PD-L1 group (n = 20). Among the 43 patients who were candidates for PCI treatment, the PCI group (n = 22) had significantly fewer events of brain metastasis as the first failure sites compared to the no PCI group (n = 21) (13.6% vs. 42.9%, P = 0.033). There were several grade 3 or 4 adverse events which were well managed with appropriate supportive care.
CONCLUSIONS


Durvalumab with CCRT for LS-SCLC exhibited promising clinical efficacy with a tolerable safety profile, prompting its validation in a randomized study.
TRIAL REGISTRATION


NCT03585998.",2022,"The positive PD-L1 group (n = 22) was not associated with longer PFS (hazard ratio, 0.70; 0.31-1.58) and overall survival (0.64; 0.22-1.84) compared with the negative PD-L1 group (n = 20).","['43 patients who were candidates for PCI treatment, the', 'limited-stage small-cell lung cancer', 'Fifty-one patients were enrolled, and 50 were included in the full analysis set']","['durvalumab consolidation therapy', 'etoposide, cisplatin, and durvalumab', 'PCI', 'Durvalumab with chemoradiotherapy', 'chemoimmunotherapy', 'chemotherapy with concurrent chemoradiotherapy (CCRT', 'Prophylactic cranial irradiation (PCI', 'Thoracic radiotherapy']","['overall survival', 'median overall survival', 'events of brain metastasis', 'median PFS', '24-month PFS rate', 'overall survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278725', 'cui_str': 'Small cell lung cancer limited stage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",51.0,0.279175,"The positive PD-L1 group (n = 22) was not associated with longer PFS (hazard ratio, 0.70; 0.31-1.58) and overall survival (0.64; 0.22-1.84) compared with the negative PD-L1 group (n = 20).","[{'ForeName': 'Sehhoon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Myoung', 'Initials': 'JM', 'LastName': 'Noh', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon-La', 'Initials': 'YL', 'LastName': 'Choi', 'Affiliation': 'Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Ah', 'Initials': 'SA', 'LastName': 'Chi', 'Affiliation': 'Department of Health Sciences and Technology, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Republic of Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Biomedical Statistics Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Ae', 'Initials': 'HA', 'LastName': 'Jung', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Se-Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jong-Mu', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: jongmu.sun@skku.edu.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.03.034']
931,35500450,Multimodal treatment efficacy differs in dependence of core symptom profiles in adult Attention-Deficit/Hyperactivity Disorder: An analysis of the randomized controlled COMPAS trial.,"There is broad consensus that to improve the treatment of adult Attention-Deficit/Hyperactivity Disorder (ADHD), the various therapy options need to be tailored more precisely to the individual patient's needs and specific symptoms. This post-hoc analysis evaluates the multimodal effects of first-line medication (methylphenidate [MPH] vs placebo [PLB]) and psychotherapeutic (group psychotherapy [GPT] vs clinical management [CM]) treatments on the ADHD core symptoms inattention, hyperactivity and impulsivity. For the two-by-two factorial, observer-blinded, multicenter, randomized controlled Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS; ISRCTN54096201), 419 outpatients with ADHD were considered for analysis. ADHD symptoms were assessed by blind observer-rated and patient-rated Conners Adult ADHD Rating Scales before treatment (T1), 13 weeks (T2) and 26 weeks (T3) after T1, at treatment completion after 52 weeks (T4), and at follow-up (130 weeks, T5). MPH was superior to PLB in improving symptoms of inattention at almost all endpoints (observer-rated T2, T3, T4, T5; patient-rated T2, T3, T4), while a significant decrease in hyperactivity and impulsivity was at first found after 6 months of treatment. CM compared to GPT decreased inattention and impulsivity in the early treatment phase only (observer-rated T2, patient-rated T2, T3). In conclusion, while MPH seems to have a direct and sustained effect on inattention, premature medication discontinuation should particularly be avoided in patients with hyperactive-impulsive symptoms. Also, especially in high inattention and/or impulsivity presentations, initial individual patient management might be beneficial. Consequently, considering individual core symptom profiles may enhance the efficacy of treatments in adult ADHD.",2022,"MPH was superior to PLB in improving symptoms of inattention at almost all endpoints (observer-rated T2, T3, T4, T5; patient-rated T2, T3, T4), while a significant decrease in hyperactivity and impulsivity was at first found after 6 months of treatment.","['patients with hyperactive-impulsive symptoms', '419 outpatients with ADHD', 'adult Attention-Deficit/Hyperactivity Disorder']","['Methylphenidate and Psychotherapy', 'first-line medication (methylphenidate [MPH] vs placebo [PLB]) and psychotherapeutic (group psychotherapy [GPT']","['inattention and impulsivity', 'hyperactivity and impulsivity', 'blind observer-rated and patient-rated Conners Adult ADHD Rating Scales', 'symptoms of inattention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]","[{'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",419.0,0.163389,"MPH was superior to PLB in improving symptoms of inattention at almost all endpoints (observer-rated T2, T3, T4, T5; patient-rated T2, T3, T4), while a significant decrease in hyperactivity and impulsivity was at first found after 6 months of treatment.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Selaskowski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Staerk', 'Affiliation': 'Department of Medical Biometry, Informatics and Epidemiology, Faculty of Medicine, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Braun', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Graf', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany; Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Colla', 'Affiliation': 'Psychiatric University Hospital Zurich, Department of Psychiatry, Psychotherapy and Psychosomatics, Zurich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany; Center of Mental Health, Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sobanski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany; Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Alm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roesler', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Retz', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany; Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Retz-Junginger', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kis', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Göttingen, Göttingen, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, St. Elisabeth Hospital Niederwenigern, Contilia Group, Hattingen, Germany; LVR-Hospital Essen, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Abdel-Hamid', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Huss', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jans', 'Affiliation': 'Center of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Tebartz van Elst', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Lux', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mayr', 'Affiliation': 'Department of Medical Biometry, Informatics and Epidemiology, Faculty of Medicine, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany. Electronic address: alexandra.philipsen@ukbonn.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.03.049']
932,35512619,Deep brain stimulation in the bed nucleus of the stria terminalis: A symptom provocation study in patients with obsessive-compulsive disorder.,"BACKGROUND


Deep brain stimulation (DBS) is an emerging therapy for treatment-resistant obsessive-compulsive disorder (OCD), and several targets for electrode implantation and contact selection have been proposed, including the bed nucleus of the stria terminalis (BST). Selecting the active electrode contacts (patients typically have four to choose from in each hemisphere), and thus the main locus of stimulation, can be a taxing process. Here, we investigated whether contact selection based purely on their neuroanatomical position in the BST is a worthwhile approach. For the first time, we also compared the effects of uni- versus bilateral BST stimulation.
METHODS


Nine OCD patients currently receiving DBS participated in a double-blind, randomized symptom provocation study to compare no versus BST stimulation. Primary outcomes were anxiety and mood ratings in response to disorder-relevant trigger images, as well as ratings of obsessions, compulsions, tendency to avoid and overall wellbeing. Furthermore, we asked whether patients preferred the electrode contacts in the BST over their regular stimulation contacts as a new treatment setting after the end of the task.
RESULTS


We found no statistically significant group differences between the four conditions (no, left, right and bilateral BST stimulation). Exploratory analyses, as well as follow-up data, did indicate that (bilateral) bipolar stimulation in the BST was beneficial for some patients, particularly for those who had achieved unsatisfactory effects through the typical contact selection procedure.
CONCLUSIONS


Despite its limitations, this study suggests that selection of stimulation contacts in the BST is a viable option for DBS in treatment-resistant OCD patients.",2022,"We found no statistically significant group differences between the four conditions (no, left, right and bilateral BST stimulation).","['stria terminalis', 'Nine OCD patients currently receiving', 'patients with obsessive-compulsive disorder']","['DBS', 'Deep brain stimulation (DBS']","['anxiety and mood ratings in response to disorder-relevant trigger images, as well as ratings of obsessions, compulsions, tendency to avoid and overall wellbeing']","[{'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",9.0,0.137786,"We found no statistically significant group differences between the four conditions (no, left, right and bilateral BST stimulation).","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Luyck', 'Affiliation': 'KU Leuven, Experimental Neurosurgery and Neuroanatomy, Herestraat 49 PB 7003, 3000, Leuven, Belgium; Leuven Brain Institute, Herestraat 49 PB 1021, 3000, Leuven, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bervoets', 'Affiliation': 'Leuven Brain Institute, Herestraat 49 PB 1021, 3000, Leuven, Belgium; University Hospitals Leuven, Psychiatry, Campus Gasthuisberg, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Choi', 'Initials': 'C', 'LastName': 'Deblieck', 'Affiliation': 'University Hospitals Leuven, Psychiatry, Campus Gasthuisberg, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Nuttin', 'Affiliation': 'KU Leuven, Experimental Neurosurgery and Neuroanatomy, Herestraat 49 PB 7003, 3000, Leuven, Belgium; Leuven Brain Institute, Herestraat 49 PB 1021, 3000, Leuven, Belgium; University Hospitals Leuven, Neurosurgery, Campus Gasthuisberg, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Luyten', 'Affiliation': 'KU Leuven, Experimental Neurosurgery and Neuroanatomy, Herestraat 49 PB 7003, 3000, Leuven, Belgium; Leuven Brain Institute, Herestraat 49 PB 1021, 3000, Leuven, Belgium; KU Leuven, Psychology of Learning and Experimental Psychopathology, Tiensestraat 102 PB 3712, 3000, Leuven, Belgium. Electronic address: laura.luyten@kuleuven.be.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.04.031']
933,35513022,"The effect of empagliflozin on contractile reserve in heart failure: Prespecified sub-study of a randomized, double-blind, and placebo-controlled trial.","BACKGROUND


Sodium-glucose co-transporter-2 inhibitors improve cardiac structure but most studies suggest no change in left ventricular (LV) systolic function at rest. Whether sodium-glucose co-transporter-2 inhibitors improve LV contractile reserve is unknown. We investigated the effect of empagliflozin on LV contractile reserve in patients with heart failure (HF) and reduced ejection fraction.
METHODS


Prespecified sub-study of the Empire HF trial, a double-blind, placebo-controlled, and randomized trial. Patients with LV ejection fraction (LVEF) ≤ 40% on guideline-directed HF therapy were randomized (1:1) to empagliflozin 10 mg or placebo for 12 weeks. The treatment effect on contractile reserve was assessed by low dose dobutamine stress echocardiography.
RESULTS


In total, 120 patients were included. The mean age was 68 (SD 10) years, 83% were male, and the mean LVEF was 38 (SD 10) %. Respectively 60 (100%) and 59 (98%) patients in the empagliflozin and placebo groups completed stress echocardiography. No statistically significant effect of empagliflozin was observed for the contractile reserve assessed by LV-GLS (adjusted mean absolute change, empagliflozin vs placebo, 0.7% [95% confidence interval {CI} -0.5 to 2.0, P = .25]) or LVEF (adjusted mean absolute change, empagliflozin vs placebo, 2.2% [95% CI -1.4 to 5.8, P = .22]) from baseline to 12 weeks. LV-GLS contractile reserve was associated with accelerometer-measured daily activity level (coefficient -24 accelerometer counts [95% CI -46 to -1.8, P = .03]).
CONCLUSIONS


Empagliflozin for 12 weeks added to guideline-directed HF therapy did not improve LV contractile reserve in patients with HF and reduced ejection fraction.",2022,"No statistically significant effect of empagliflozin was observed for the contractile reserve assessed by LV-GLS [adjusted mean absolute change, empagliflozin versus placebo, 0.7% (95% CI -0.5 to 2.0, P=0.25)] or LVEF [adjusted mean absolute change, empagliflozin versus placebo, 2.2% (95% CI -1.4 to 5.8, P=0.22)] from baseline to 12 weeks.","['patients with heart failure (HF) and reduced ejection fraction (HFrEF', 'Heart Failure', 'Patients with LV ejection fraction (LVEF) ≤40% on guideline-directed HF therapy', 'The mean age was 68 (SD 10) years, 83% were male, and the mean LVEF was 38 (SD 10) ', '120 patients were included']","['Empagliflozin', 'empagliflozin 10 mg or placebo', 'Placebo', 'empagliflozin', 'SGLT2 inhibitors', 'Sodium-glucose co-transporter-2 (SGLT2) inhibitors', 'placebo']","['LV contractile reserve', 'left ventricular (LV) systolic function', 'LV-GLS contractile reserve', 'stress echocardiography', 'daily activity level [coefficient -24 accelerometer counts', 'contractile reserve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",120.0,0.704992,"No statistically significant effect of empagliflozin was observed for the contractile reserve assessed by LV-GLS [adjusted mean absolute change, empagliflozin versus placebo, 0.7% (95% CI -0.5 to 2.0, P=0.25)] or LVEF [adjusted mean absolute change, empagliflozin versus placebo, 2.2% (95% CI -1.4 to 5.8, P=0.22)] from baseline to 12 weeks.","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Massar', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Steno Diabetes Center Odense, Odense, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Mulham', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Frederiksen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Camilla F', 'Initials': 'CF', 'LastName': 'Andersen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Larsen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Mads Kristian', 'Initials': 'MK', 'LastName': 'Ersbøll', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Internal Medicine, Center of Endocrinology and Metabolism, Herlev and Gentofte University Hospital, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Julie Lyng', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark; Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. Electronic address: morten.schou.04@regionh.dk.'}]",American heart journal,['10.1016/j.ahj.2022.04.008']
934,35487183,Quality of life assessment of cabozantinib in patients with advanced hepatocellular carcinoma in the CELESTIAL trial.,"BACKGROUND


The CELESTIAL trial (NCT01908426) demonstrated overall survival benefit for cabozantinib versus placebo in patients with advanced hepatocellular carcinoma (aHCC) who had received prior sorafenib treatment. This analysis of CELESTIAL compared the impact of cabozantinib versus placebo on health-related quality of life (HRQoL).
MATERIALS AND METHODS


Health status was assessed using the EuroQol five-dimension five-level (EQ-5D-5L) questionnaire over the 800-day follow-up period. EQ-5D-5L health states were mapped to health utility scores using reference values for the UK population. Quality-adjusted life years (QALYs) were calculated for each treatment group as the area under the curve for the plot of health utility score over time. The between-treatment group difference in restricted mean QALYs was calculated by generalized linear models and adjusted for baseline differences. A difference of 0.08 in health utility score (or in QALY) was deemed a minimally important difference and to be clinically significant.
RESULTS


At week 5, the difference in mean health utility score between cabozantinib and placebo was -0.097 (95% confidence interval [95% CI]: -0.126, -0.067; p ≤ 0.001). Between-group differences in health utility scores diminished over time and were generally non-significant. The cabozantinib group accrued more QALYs than the placebo group over follow-up. Differences in mean QALYs (cabozantinib minus placebo) were statistically and clinically significant, ranging from +0.092 (95% CI: 0.016, 0.169) to +0.185 (95% CI: 0.126, 0.243) in favour of cabozantinib, depending on the reference value set used.
CONCLUSIONS


These HRQoL findings support a positive benefit-risk profile for cabozantinib in previously treated patients with aHCC.",2022,"Differences in mean QALYs (cabozantinib minus placebo) were statistically and clinically significant, ranging from +0.092 (95% CI: 0.016, 0.169) to +0.185 (95% CI: 0.126, 0.243) in favour of cabozantinib, depending on the reference value set used.
","['patients with advanced hepatocellular carcinoma (aHCC) who had received prior sorafenib treatment', 'patients with advanced hepatocellular carcinoma']","['placebo', 'cabozantinib versus placebo']","['health-related quality of life (HRQoL', 'restricted mean QALYs', 'Quality of life assessment of cabozantinib', 'health utility score', 'mean health utility score', 'mean QALYs (cabozantinib minus placebo', 'Quality-adjusted life years (QALYs', 'overall survival benefit', 'health utility scores', 'EuroQol five-dimension five-level (EQ-5D-5L) questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.424204,"Differences in mean QALYs (cabozantinib minus placebo) were statistically and clinically significant, ranging from +0.092 (95% CI: 0.016, 0.169) to +0.185 (95% CI: 0.126, 0.243) in favour of cabozantinib, depending on the reference value set used.
","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'University College London, London, UK. Electronic address: nicholas.freemantle@ucl.ac.uk.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mollon', 'Affiliation': 'Ipsen Pharma SAS, Boulogne-Billancourt, France.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taiwan, Republic of China.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Norris Comprehensive Cancer Center, Keck School of Medicine of USC, Los Angeles, CA, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Ari D', 'Initials': 'AD', 'LastName': 'Baron', 'Affiliation': 'California Pacific Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Fawzi', 'Initials': 'F', 'LastName': 'Benzaghou', 'Affiliation': 'Ipsen Bioscience, Cambridge, MA, USA.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Mangeshkar', 'Affiliation': 'Exelixis, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Medical College at Cornell University, New York, NY, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.03.021']
935,35499850,Efficacy and Safety of Fenfluramine for the Treatment of Seizures Associated With Lennox-Gastaut Syndrome: A Randomized Clinical Trial.,"Importance


New treatment options are needed for patients with Lennox-Gastaut syndrome (LGS), a profoundly impairing, treatment-resistant, developmental and epileptic encephalopathy.
Objective


To evaluate the efficacy and safety of fenfluramine in patients with LGS.
Design, Setting, and Participants


This multicenter, double-blind, placebo-controlled, parallel-group randomized clinical trial was conducted from November 27, 2017, to October 25, 2019, and had a 20-week trial duration. Patients were enrolled at 65 study sites in North America, Europe, and Australia. Included patients were aged 2 to 35 years with confirmed diagnosis of LGS and experienced 2 or more drop seizures per week during the 4-week baseline. Using a modified intent-to-treat method, data analysis was performed from November 27, 2017, to October 25, 2019. The database lock date was January 30, 2020, and the date of final report was September 11, 2021.
Interventions


Patients were randomized to receive either a 0.7-mg/kg/d or 0.2-mg/kg/d (maximum 26 mg/d) dose of fenfluramine or placebo. After titration (2-week period), patients were taking their randomized dose for 12 additional weeks.
Main Outcomes and Measures


Primary efficacy end point was percentage change from baseline in drop seizure frequency in patients who received 0.7 mg/kg/d of fenfluramine vs placebo.
Results


A total of 263 patients (median [range] age, 13 [2-35] years; 146 male patients [56%]) were randomized to the 0.7-mg/kg/d fenfluramine group (n = 87), 0.2-mg/kg/d fenfluramine group (n = 89), or placebo group (n = 87). The median percentage reduction in frequency of drop seizures was 26.5 percentage points in the 0.7-mg/kg/d fenfluramine group, 14.2 percentage points in the 0.2-mg/kg/d fenfluramine group, and 7.6 percentage points in the placebo group. The trial met its primary efficacy end point: patients in the 0.7-mg/kg/d fenfluramine group achieved a -19.9 percentage points (95% CI, -31.0 to -8.7 percentage points; P = .001) estimated median difference in drop seizures from baseline vs placebo. More patients in the 0.7-mg/kg/d fenfluramine group achieved a 50% or greater response (22 of 87 [25%]; P = .02) vs placebo (9 of 87 [10%]). Site investigators and caregivers gave a much improved or very much improved rating on the Clinical Global Impression of Improvement scale to more patients in the 0.7-mg/kg/d fenfluramine group than patients in the placebo group (21 [26%] vs 5 [6%]; P = .001). The seizure subtype that appeared most responsive to fenfluramine was generalized tonic-clonic seizure (120 of 263 [46%]), with a decrease in frequency of 45.7% in the 0.7-mg/kg/d fenfluramine group and 58.2% in the 0.2-mg/kg/d fenfluramine group compared with an increase of 3.7% in the placebo group. Most common treatment-emergent adverse events included decreased appetite (59 [22%]), somnolence (33 [13%]), and fatigue (33 [13%]). No cases of valvular heart disease or pulmonary arterial hypertension were observed.
Conclusions and Relevance


Results of this trial showed that, in patients with LGS, fenfluramine compared with placebo provided a significantly greater reduction in drop seizures and may be a particularly advantageous choice in patients who experience generalized tonic-clonic seizures.
Trial Registration


ClinicalTrials.gov Identifier: NCT03355209.",2022,Site investigators and caregivers gave a much improved or very much improved rating on the Clinical Global Impression of Improvement scale to more patients in the 0.7-mg/kg/d fenfluramine group than patients in the placebo group (21 [26%] vs 5 [6%]; P = .001).,"['patients with Lennox-Gastaut syndrome (LGS', 'Patients were enrolled at 65 study sites in North America, Europe, and Australia', 'Lennox-Gastaut Syndrome', '263 patients (median [range] age, 13 [2-35] years; 146 male patients [56', 'patients with LGS', 'Included patients were aged 2 to 35 years with confirmed diagnosis of LGS and experienced 2 or more drop seizures per week during the 4-week baseline', 'November 27, 2017, to October 25, 2019, and had a 20-week trial duration', 'Seizures']","['placebo', 'fenfluramine or placebo', 'fenfluramine', 'Fenfluramine']","['valvular heart disease or pulmonary arterial hypertension', 'Clinical Global Impression of Improvement scale', 'generalized tonic-clonic seizure', 'efficacy and safety', 'frequency of drop seizures', 'drop seizures', 'Efficacy and Safety', 'somnolence', 'appetite']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0270846', 'cui_str': 'Epileptic drop attack'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011786', 'cui_str': 'Dexfenfluramine'}]","[{'cui': 'C0018824', 'cui_str': 'Heart valve disorder'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0270846', 'cui_str': 'Epileptic drop attack'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}]",263.0,0.492387,Site investigators and caregivers gave a much improved or very much improved rating on the Clinical Global Impression of Improvement scale to more patients in the 0.7-mg/kg/d fenfluramine group than patients in the placebo group (21 [26%] vs 5 [6%]; P = .001).,"[{'ForeName': 'Kelly G', 'Initials': 'KG', 'LastName': 'Knupp', 'Affiliation': ""Department of Neurology, Children's Hospital Colorado, Aurora.""}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Scheffer', 'Affiliation': ""Austin Hospital and Royal Children's Hospital, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Berten', 'Initials': 'B', 'LastName': 'Ceulemans', 'Affiliation': 'Department of Paediatric Neurology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Sullivan', 'Affiliation': ""Weill Institute for Neurosciences, Benioff Children's Hospital, University of California San Francisco, San Francisco.""}, {'ForeName': 'Katherine C', 'Initials': 'KC', 'LastName': 'Nickels', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Lagae', 'Affiliation': 'Steering Committee, European Reference Network EpiCARE, Lyon, France.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Guerrini', 'Affiliation': ""Pediatric Neurology and Neurogenetics Unit, Anna Meyer Children's Hospital, University of Florence, Florence, Italy.""}, {'ForeName': 'Sameer M', 'Initials': 'SM', 'LastName': 'Zuberi', 'Affiliation': 'Paediatric Neurosciences Research Group, Royal Hospital for Children, Glasgow, United Kingdom.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Nabbout', 'Affiliation': 'Department of Pediatric Neurology, Reference Centre for Rare Epilepsies, Necker-Enfants Malades Hospital, Imagine Institute, University Paris Descartes, Paris, France.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Riney', 'Affiliation': ""Neuroscience Unit, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Shore', 'Affiliation': 'Zogenix Inc, Emeryville, California.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Zogenix Inc, Emeryville, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'Zogenix Inc, Emeryville, California.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Farfel', 'Affiliation': 'Zogenix Inc, Emeryville, California.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Galer', 'Affiliation': 'Zogenix Inc, Emeryville, California.'}, {'ForeName': 'Arnold R', 'Initials': 'AR', 'LastName': 'Gammaitoni', 'Affiliation': 'Zogenix Inc, Emeryville, California.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Davis', 'Affiliation': 'Neurology and Epilepsy Research Center, Orlando, Florida.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gil-Nagel', 'Affiliation': 'Department of Neurology, Epilepsy Program, Hospital Ruber Internacional, Madrid, Spain.'}]",JAMA neurology,['10.1001/jamaneurol.2022.0829']
936,35500883,NIV-NAVA versus NCPAP immediately after birth in premature infants: A randomized controlled trial.,"OBJECTIVE


To evaluate whether noninvasive-neurally adjusted ventilatory assist (NIV-NAVA) decrease respiratory efforts compared to nasal continuous positive airway pressure (NCPAP) during the first hours of life.
METHODS


Twenty infants born between 28 +0  and 31 +6  weeks were randomized to NIV-NAVA or NCPAP. Positive end-expiratory pressure was constantly kept at 6 cmH 2 O for both groups and the NAVA level was 1.0 cmH 2 O/µV for NIV-NAVA group. The electrical activity of diaphragm (Edi) were recorded for the first two hours.
RESULTS


Peak and minimum Edi decreased similarly in both groups (P = 0.98 and P = 0.59, respectively). Leakages were higher in the NIV-NAVA group than in the NCPAP group (P < 0.001). The neural apnea defined as a flat Edi for ≥ 5 s were less frequent in NIV-NAVA group than in NCPAP group (P = 0.046).
CONCLUSIONS


Immediately applied NIV-NAVA in premature infants did not reduce breathing effort, measured as peak Edi. However, NIV-NAVA decreased neural apneic episodes compared to NCPAP.",2022,"RESULTS


Peak and minimum Edi decreased similarly in both groups (P = 0.98 and P = 0.59, respectively).","['Twenty infants born between 28 +0  and 31 +6  weeks', 'premature infants']","['noninvasive-neurally adjusted ventilatory assist (NIV-NAVA', 'NCPAP', 'NIV-NAVA versus NCPAP', 'NIV-NAVA or NCPAP']","['neural apnea', 'neural apneic episodes', 'Peak and minimum Edi', 'Positive end-expiratory pressure', 'electrical activity of diaphragm (Edi']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}]",20.0,0.0759596,"RESULTS


Peak and minimum Edi decreased similarly in both groups (P = 0.98 and P = 0.59, respectively).","[{'ForeName': 'Juyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Inha University Hospital, Inha University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Vilhelmiina', 'Initials': 'V', 'LastName': 'Parikka', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Oda', 'Affiliation': ""Division of Neonatology, Nagano Children's Hospital, Nagano, Japan.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wallström', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Lehtonen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Soukka', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland. Electronic address: hanna.soukka@tyks.fi.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2022.103916']
937,35500846,The effects of using a micro-infusion pump without accompanying fluid at a low flow rate on patients undergoing cardiac surgery.,"BACKGROUND


Since a micro-infusion pump continuously pumps drugs at a low speed, it has the risk of complications including venous blood return, indwelling needle blockage, and the lack of regular delivery of drugs. This study aimed to investigate venous blood return and indwelling needle blockage after cardiac surgery when a micro-infusion pump was used at a very low flow rate of only 2 ml/h without any accompanying fluid.
METHODS


A total of 215 patients, who were hospitalized at the Second Hospital of Shandong University between May and December 2020, received a continuous intravenous administration of drugs via a micro-infusion pump at 2 ml/h without or with accompanying fluid. These patients were randomly divided into an observation group (108 patients) and a control group (107 patients). In the observation group, drugs were administered at 2 ml/h without any additional fluid. In contrast, the control group received drugs also at 2 ml/h but with a normal saline through an intravenous drip. The venous backflow, blockage of the indwelling needle and catheter, and other adverse reactions were evaluated In addition, the volume of an accompanying fluid as well as the mean of nursing work time and additional costs were calculated.
RESULTS


The main finding of this analysis showed no statistically significant differences in the number of complications such as venous backflow, blockage of the indwelling needle or catheter, or any adverse reactions between the observational and control groups (P > 0.05). Compared to the control group, the observation group had significantly reduced the amount of fluid intake (P< 0.001). In addition, the 2 ml/h infusion tempo without any additional fluid shortened nursing hours (P < 0.001), and thus reduced costs for the observation group vs. the control group.
CONCLUSIONS


It is feasible and safe to administer drugs via a micro-infusion pump at the slow 2 ml/h tempo without any accompanying fluid to patients after surgery requiring minimal volume of fluids.",2022,"Compared to the control group, the observation group had significantly reduced the amount of fluid intake (P < 0.001).","['patients undergoing cardiac surgery', '215 patients, who were hospitalized at the Second Hospital of Shandong University between May and December 2020']",['continuous intravenous administration of drugs via a micro-infusion pump at 2\u202fml/h without or with accompanying fluid'],"['amount of fluid intake', 'reduced costs', 'mean of nursing work time and additional costs', 'venous backflow, blockage of the indwelling needle and catheter, and other adverse reactions', 'number of complications such as venous backflow, blockage of the indwelling needle or catheter, or any adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0021436', 'cui_str': 'Infusion pump'}, {'cui': 'C0439391', 'cui_str': 'mL/h'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]","[{'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",215.0,0.151527,"Compared to the control group, the observation group had significantly reduced the amount of fluid intake (P < 0.001).","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': 'Department of Orthopaedics, The Second Hospital, Cheeloo college of Medicine, Shandong University, Jinan 250033, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, The Second Hospital, Cheeloo college of Medicine, Shandong University, Jinan 250033, China.'}, {'ForeName': 'Li-Huan', 'Initials': 'LH', 'LastName': 'He', 'Affiliation': 'Department of Cardiovascular Surgery, The Second Hospital, Cheeloo college of Medicine, Shandong University, Jinan 250033, China.'}, {'ForeName': 'Jian-Hong', 'Initials': 'JH', 'LastName': 'Wan', 'Affiliation': 'Department of Cardiovascular Surgery, The Second Hospital, Cheeloo college of Medicine, Shandong University, Jinan 250033, China. Electronic address: wamjh309@tom.com.'}]",Transplant immunology,['10.1016/j.trim.2022.101611']
938,35504256,Patient-Ventilator Synchrony in Extremely Premature Neonates during Non-Invasive Neurally Adjusted Ventilatory Assist or Synchronized Intermittent Positive Airway Pressure: A Randomized Crossover Pilot Trial.,"INTRODUCTION


Synchronization of non-invasive ventilation is challenging in extremely premature infants. We compared patient-ventilator synchrony between non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using transdiaphragmatic (Edi) catheter and synchronized intermittent positive airway pressure (SiPAP) using an abdominal trigger.
METHODS


This study was a monocentric, randomized, crossover trial in premature infants born before 28 weeks of gestation, aged 3 days or more, and below 32 weeks postmenstrual age. NIV-NAVA and SiPAP were applied in a random order for 2 h with analysis of data from the second hour. The primary outcome was the asynchrony index.
RESULTS


Fourteen patients were included (median [IQR] gestational age at birth 25.6 (25.3-26.4) weeks, median [IQR] birth weight 755 [680-824] g, median [IQR] postnatal age 26.5 [19.8-33.8] days). The median (IQR) asynchrony index was significantly lower in NIV-NAVA versus SiPAP (49.9% [44.1-52.6] vs. 85.8% [74.2-90.9], p < 0.001). Ineffective efforts and auto-triggering were significantly less frequent in NIV-NAVA versus SiPAP (3.0% vs. 32.0% p < 0.001 and 10.0% vs. 26.6%, p = 0.004, respectively). Double triggering was significantly less frequent in SiPAP versus NIV-NAVA (0.0% vs. 9.0%, p < 0.001). No significant difference was observed for premature cycling and late cycling. Peak Edi and swing Edi were significantly lower in NIV-NAVA as compared to SiPAP (7.7 [6.1-9.9] vs. 11.0 [6.7-14.5] μV, p = 0.006; 5.4 [4.2-7.6] vs. 7.6 [4.3-10.8] μV, p = 0.007, respectively). No significant difference was observed between NIV-NAVA and SiPAP for heart rate, respiratory rate, COMFORTneo scores, apnoea, desaturations, or bradycardias.
DISCUSSION/CONCLUSION


NIV-NAVA markedly improves patient-ventilator synchrony as compared to SiPAP in extremely premature infants.",2022,"No significant difference was observed between NIV-NAVA and SiPAP for heart rate, respiratory rate, COMFORTneo scores, apnoea, desaturations, or bradycardias.
","['Fourteen patients were included (median [IQR] gestational age at birth 25.6 (25.3-26.4) weeks, median [IQR] birth weight 755 [680-824] g, median [IQR] postnatal age 26.5 [19.8-33.8] days', 'premature infants born before 28 weeks of gestation, aged 3 days or more, and below 32 weeks postmenstrual age', 'extremely premature infants']","['NIV-NAVA', 'patient-ventilator synchrony between non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using transdiaphragmatic (Edi) catheter and synchronized intermittent positive airway pressure (SiPAP', 'NIV-NAVA and SiPAP', 'Invasive Neurally Adjusted Ventilatory Assist or Synchronized Intermittent Positive Airway Pressure']","['median (IQR) asynchrony index', 'patient-ventilator synchrony', 'NIV-NAVA and SiPAP for heart rate, respiratory rate, COMFORTneo scores, apnoea, desaturations, or bradycardias', 'asynchrony index', 'premature cycling and late cycling', 'Peak Edi and swing']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",14.0,0.227077,"No significant difference was observed between NIV-NAVA and SiPAP for heart rate, respiratory rate, COMFORTneo scores, apnoea, desaturations, or bradycardias.
","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Treussart', 'Affiliation': 'Neonatal Intensive Care Unit, CHI Créteil, Créteil, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Decobert', 'Affiliation': 'Neonatal Intensive Care Unit, CHI Créteil, Créteil, France.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Tauzin', 'Affiliation': 'Neonatal Intensive Care Unit, CHI Créteil, Créteil, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bourgoin', 'Affiliation': 'Neonatal Intensive Care Unit, Assistance Publique, Hôpitaux de Marseille, Hôpital de La Conception, Marseille, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Danan', 'Affiliation': 'Neonatal Intensive Care Unit, CHI Créteil, Créteil, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dassieu', 'Affiliation': 'Neonatal Intensive Care Unit, CHI Créteil, Créteil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Carteaux', 'Affiliation': 'INSERM, CNRS ERL 7000, IMRB, Université Paris Est Creteil, Créteil, France.'}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Mekontso-Dessap', 'Affiliation': 'Medical Intensive Care Unit, Assistance Publique-Hôpitaux de Paris, Centre Hospitalier Universitaire Henri Mondor, Créteil, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Louis', 'Affiliation': 'INSERM, CNRS ERL 7000, IMRB, Université Paris Est Creteil, Créteil, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Durrmeyer', 'Affiliation': 'Neonatal Intensive Care Unit, CHI Créteil, Créteil, France.'}]",Neonatology,['10.1159/000524327']
939,35504988,Development of a prognostic nomogram for metastatic pancreatic ductal adenocarcinoma integrating marital status.,"Previous studies have shown that marital status can affect the overall survival (OS) of cancer patients yet its role in metastatic pancreatic ductal adenocarcinoma (mPDAC) remains unclear. This study aimed to explore the impact of marital status on the OS of mPDAC patients and to construct a prognostic nomogram to predict OS outcomes. Data from patients diagnosed with mPDAC were obtained from the Surveillance, Epidemiology, and End Results database between 1973 and 2015. The patients were randomized into primary and validation cohorts. Kaplan-Meier survival analysis was performed to compare differences in survival depending on marital status. Univariate and multivariate analyses were conducted to identify independent prognostic factors and a nomogram was established based using Cox regression analyses. Validation of the prognostic nomogram was evaluated with a calibration curve and concordance index (C-index). Our data showed significant differences in the OS of mPDAC patients with different marital status by Kaplan-Meier analysis (P < 0.05). Univariate and multivariate analyses confirmed that marital status was an independent OS-related factor in mPDAC patients. Based on the multivariate models of the primary cohort, a nomogram was developed that combined marital status, age, grade, tumor size, surgery of primary site, surgery of lymph node and metastatic. The nomogram showed that marital status had a moderate influence on predicting the OS of mPDAC patients. Moreover, the internally and externally validated C-indexes were 0.633 and 0.619, respectively. A calibration curve confirmed favorable consistency between the observed and predicted outcomes. Marital status was identified as an independent prognostic factor for OS of mPDAC patients and is a reliable and valid parameter to predict the survival of patients with mPDAC. This prognostic model has value and may be integrated as a tool to inform decision-making in the clinic.",2022,Marital status was identified as an independent prognostic factor for OS of mPDAC patients and is a reliable and valid parameter to predict the survival of patients with mPDAC.,['metastatic pancreatic ductal adenocarcinoma integrating marital status'],[],"['calibration curve and concordance index (C-index', 'overall survival (OS']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}]",[],"[{'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0807709,Marital status was identified as an independent prognostic factor for OS of mPDAC patients and is a reliable and valid parameter to predict the survival of patients with mPDAC.,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Yunnan Caner Hospital, The Third Affiliated Hospital of Kunming Medical University, Kunming, 650118, China.'}, {'ForeName': 'Junlong', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Kunming Medical University, Kunming, China.'}, {'ForeName': 'Cuiting', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Kunming Medical University, Kunming, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Yunnan Caner Hospital, The Third Affiliated Hospital of Kunming Medical University, Kunming, 650118, China. 349144927@qq.com.'}]",Scientific reports,['10.1038/s41598-022-11318-1']
940,35506577,Improving donor retention following a temporary deferral: A cluster randomized controlled trial of deferral educational materials.,"BACKGROUND


Providing educational materials to deferred donors has been shown to increase their understanding about their deferral and knowledge about their return. The aim of this study was to determine the effectiveness of educational materials in increasing the retention of deferred donors.
STUDY DESIGN AND METHODS


A three-arm cluster randomized controlled trial was conducted, with the following conditions: (a) Incenter Brochure plus Email; (b) Email Only; (c) Control. The Incenter Brochure plus Email condition also included a guided conversation led by staff at the point of deferral. Donors were followed up for 3 months after their deferral had ended to determine if they had attempted to donate.
RESULTS


Compared with the Control condition, donors in the Incenter Brochure plus Email condition had increased odds of return at 3 months after their deferral ended (OR: 1.16; 95% CI 1.00-1.33). Subgroup analysis highlighted that novice (OR: 1.38; 95% CI 1.04-1.83) and established donors (OR: 1.36; 95% CI 1.13-1.64) had increased odds of return if they received the incenter materials. Donors who were deferred to maintain their well-being (OR: 1.28; 95% CI 1.03-1.60) and donors with a prior deferral history (OR: 1.55; 95% CI 1.15-1.55) had increased odds of return if they received the incenter materials. No significant differences were found between the Email Only and Control conditions.
DISCUSSION


This trial demonstrates the benefits of providing onsite educational materials to donors at the point of deferral. This is a simple, effective strategy to increase the return behavior of donors within 3 months of their deferral ending.",2022,Subgroup analysis highlighted that novice (OR: 1.38; 95% CI 1.04-1.83) and established donors (OR: 1.36; 95% CI 1.13-1.64) had increased odds of return if they received the incenter materials.,['Donors who were deferred to maintain their well-being '],['Incenter Brochure plus Email; (b) Email Only; (c) Control'],['odds of return'],"[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}]",,0.159339,Subgroup analysis highlighted that novice (OR: 1.38; 95% CI 1.04-1.83) and established donors (OR: 1.36; 95% CI 1.13-1.64) had increased odds of return if they received the incenter materials.,"[{'ForeName': 'Carley N', 'Initials': 'CN', 'LastName': 'Gemelli', 'Affiliation': 'Clinical Services and Research, Australian Red Cross Lifeblood, Melbourne, Australia.'}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Kruse', 'Affiliation': 'Clinical Services and Research, Australian Red Cross Lifeblood, Melbourne, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Thijsen', 'Affiliation': 'Clinical Services and Research, Australian Red Cross Lifeblood, Sydney, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Van Dyke', 'Affiliation': 'Clinical Services and Research, Australian Red Cross Lifeblood, Melbourne, Australia.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Karki', 'Affiliation': 'Clinical Services and Research, Australian Red Cross Lifeblood, Sydney, Australia.'}, {'ForeName': 'Tanya E', 'Initials': 'TE', 'LastName': 'Davison', 'Affiliation': 'Clinical Services and Research, Australian Red Cross Lifeblood, Melbourne, Australia.'}]",Transfusion,['10.1111/trf.16892']
941,35508218,Incidental affective influences on effort-related cardiac response: The critical role of choosing task characteristics.,"This experiment tested whether personal choice vs. external assignment of task characteristics moderates the effect of incidental affective stimulation on effort-related cardiovascular response. We expected strong action shielding and low receptivity for incidental affective influences when participants could choose themselves the stimulus color of an easy memory task. By contrast, when the stimulus color was assigned, we expected weak action shielding and high receptivity. As expected, participants in the assigned color condition showed stronger cardiac pre-ejection period reactivity when exposed to sad music than when exposed to happy music during task performance. These music effects did not appear among participants who could personally choose the stimulus color. Our results replicate previous research by showing that personal choice leads to action shielding, whereas individuals remain receptive for affective influences during volition when task characteristics are assigned.",2022,This experiment tested whether personal choice vs. external assignment of task characteristics moderates the effect of incidental affective stimulation on effort-related cardiovascular response.,[],[],['stronger cardiac pre-ejection period reactivity'],[],[],"[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0247178,This experiment tested whether personal choice vs. external assignment of task characteristics moderates the effect of incidental affective stimulation on effort-related cardiovascular response.,"[{'ForeName': 'Johanna R', 'Initials': 'JR', 'LastName': 'Falk', 'Affiliation': 'University of Geneva, Switzerland. Electronic address: johanna.falk@unige.ch.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gollwitzer', 'Affiliation': 'New York University, Germany; University of Konstanz, Germany; Leuphana University of Lueneburg, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Oettingen', 'Affiliation': 'New York University, Germany; University of Hamburg, Germany.'}, {'ForeName': 'Guido H E', 'Initials': 'GHE', 'LastName': 'Gendolla', 'Affiliation': 'University of Geneva, Switzerland. Electronic address: guido.gendolla@unige.ch.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2022.04.010']
942,35525420,"Relationship among chrononutrition, sleep, and glycemic control in women with gestational diabetes mellitus: a randomized controlled trial.","BACKGROUND


Gestational diabetes mellitus is associated with an increased risk of maternal, fetal, and neonatal morbidities. Chronobiological disorders have recently been identified as risk factors for those morbidities. The disorders include chrononutritional disorders related to meal frequency and content according to the sleep-wake cycle, sleep disorders related to sleep quality, and chrono-obesity disorders, such as abnormal weight gain because of sleep deprivation and time of eating.
OBJECTIVE


This study aimed to assess whether a chrononutritional and sleep hygiene intervention can improve maternal glycemic control and reduce the proportion of large-for-gestational-age newborns among women with gestational diabetes mellitus.
STUDY DESIGN


This randomized controlled trial included 103 women with gestational diabetes mellitus who were carrying a singleton fetus and assigned to either the intervention group (n=33) or the control group (n=70). The intervention group was assigned to a chrononutrition and sleep hygiene program, in addition to the usual care for gestational diabetes mellitus, from the time of diabetes mellitus diagnosis to birth, whereas the control group received the usual gestational diabetes mellitus care.
RESULTS


The chrononutritional and sleep hygiene intervention significantly reduced the proportion of women with suboptimal glycemic control (<80% of the plasma glucose values at target), after adjustment for maternal age, prepregnancy body mass index, gravidity, history of gestational diabetes mellitus, and large for gestational age (relative risk, 0.28; 95% confidence interval, 0.18-0.81). The effect of the intervention on balancing maternal glycemic control was mainly because of the decreased carbohydrate intake in the evening interval of the day (relative risk, 0.8; 95% confidence interval, 0.64-0.99). However, the intervention had no effect on the proportion of large-for-gestational-age newborns.
CONCLUSION


The chrononutritional and sleep hygiene intervention can improve maternal glycemic control.",2022,"The intervention had no effect on the proportion of large for gestational age newborns.
","['103 women with GDM who were carrying a singleton fetus, and assigned to either an intervention group (n=33) or control group (n=70', 'Gestational diabetes mellitus (GDM', 'women with gestational diabetes', 'gestational age newborns among women with GDM.\nSTUDY DESIGN']","['chrono-nutrition, sleep and glycemic control', 'chrono-nutritional and sleep hygiene intervention', 'usual GDM care', 'chrono-nutrition and sleep hygiene program, in addition to the usual care for GDM', 'Chrono-nutritional and sleep hygiene intervention']","['balancing maternal glycemic control', 'maternal glycemic control', 'proportion of large for gestational age newborns', 'carbohydrate intake', 'proportion of women with suboptimal glycemic control']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4304643', 'cui_str': 'Large for gestational age newborn'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",103.0,0.025456,"The intervention had no effect on the proportion of large for gestational age newborns.
","[{'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Messika', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (Drs Messika, Toledano, Hadar, Shmuel, and Tauman); Sleep Disorders Center, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel (Dr Tauman). Electronic address: amalia.messika@gmail.com.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Toledano', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (Drs Messika, Toledano, Hadar, Shmuel, and Tauman); Sleep Disorders Center, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel (Dr Tauman).'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Hadar', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (Drs Messika, Toledano, Hadar, Shmuel, and Tauman); Sleep Disorders Center, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel (Dr Tauman).'}, {'ForeName': 'Eliassaf', 'Initials': 'E', 'LastName': 'Shmuel', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (Drs Messika, Toledano, Hadar, Shmuel, and Tauman); Sleep Disorders Center, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel (Dr Tauman).'}, {'ForeName': 'Riva', 'Initials': 'R', 'LastName': 'Tauman', 'Affiliation': ""Sleep Disorders Center, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel (Dr Tauman); Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel, Petah Tikva, Israel (Dr Shamir).""}, {'ForeName': 'Raanan', 'Initials': 'R', 'LastName': 'Shamir', 'Affiliation': 'Lea and Arieh Pickel Chair for Pediatric Research, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (Dr Shamir); and Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Froy', 'Affiliation': 'Environment, The Hebrew University of Jerusalem, Rehovot, Israel (Dr Froy).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100660']
943,35489304,"Bilateral erector spinae plane blocks in children undergoing cardiac surgery: A randomized, controlled study.","STUDY OBJECTIVE


We aimed to test the hypothesis that erector spinae plane block (ESPB) provides efficient analgesia and reduces postoperative morphine consumption in children undergoing cardiac surgery with median sternotomy.
DESIGN


A prospective, blinded, randomized, controlled study.
SETTING


A tertiary university hospital, operating room and intensive care unit.
PATIENTS


Forty children aged 2-10 years, who underwent cardiac surgery with median sternotomy. The patients were randomly divided into the block group (Group B) and the control group (Group C).
INTERVENTIONS


Group B (n = 20) were treated with ultrasound-guided bilateral ESPB at the level of the T4-T5 transverse process, whereas no block was administered in Group C (n = 20). In all children, intravenous morphine at 0.05 mg/kg was used whenever the modified objective pain score (MOPS) ≥4 for postoperative analgesia.
MEASUREMENTS


The MOPS and Ramsay sedation score (RSS) were assessed at 0, 1, 2, 4, 6, 8, 10, 12, 16, 20 and 24 h postoperatively. Total morphine consumption at 24 h, extubation time and length of intensive care unit (ICU) stay was also evaluated and recorded.
MAIN RESULTS


Bilateral ESPB significantly decreased the consumption of morphine in the first 24 h, postoperatively. During the postoperative 24-h follow-up, 11 children in Group C requested morphine and the cumulative dose of morphine was 0.83 ± 0.91 mg, while 4 children in Group B requested morphine and the cumulative dose of morphine was 0.26 ± 0.59 mg (p = 0.043). There was no significant difference between Groups B and C in terms of MOPS and RSS values, extubation time or length of ICU stay.
CONCLUSION


Ultrasound-guided bilateral ESPB with bupivacaine provides efficient postoperative analgesia and reduces postoperative morphine consumption at 24 h in children undergoing cardiac surgery.",2022,"There was no significant difference between Groups B and C in terms of MOPS and RSS values, extubation time or length of ICU stay.
","['Forty children aged 2-10\xa0years, who underwent cardiac surgery with median sternotomy', '10, 12, 16, 20 and 24', 'A tertiary university hospital, operating room and intensive care unit', 'children undergoing cardiac surgery', 'children undergoing cardiac surgery with median sternotomy']","['erector spinae plane block (ESPB', 'morphine', 'ultrasound-guided bilateral ESPB at the level of the T4-T5 transverse process, whereas no block was administered in Group C ', 'Bilateral erector spinae plane blocks', 'bupivacaine']","['Total morphine consumption at 24\xa0h, extubation time and length of intensive care unit (ICU) stay', 'modified objective pain score (MOPS', 'consumption of morphine', 'MOPS and Ramsay sedation score (RSS', 'MOPS and RSS values, extubation time or length of ICU stay', 'postoperative morphine consumption']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",40.0,0.175505,"There was no significant difference between Groups B and C in terms of MOPS and RSS values, extubation time or length of ICU stay.
","[{'ForeName': 'Feride', 'Initials': 'F', 'LastName': 'Karacaer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Çukurova University, Adana, Turkey. Electronic address: feridekaracaer@gmail.com.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Biricik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Çukurova University, Adana, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Ilgınel', 'Affiliation': 'Department of Anesthesiology and Reanimation, Çukurova University, Adana, Turkey.'}, {'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'Tunay', 'Affiliation': 'Department of Anesthesiology and Reanimation, Çukurova University, Adana, Turkey.'}, {'ForeName': 'Şah', 'Initials': 'Ş', 'LastName': 'Topçuoğlu', 'Affiliation': 'Department of Cardiovascular Surgery, Çukurova University, Adana, Turkey.'}, {'ForeName': 'Hakkı', 'Initials': 'H', 'LastName': 'Ünlügenç', 'Affiliation': 'Department of Anesthesiology and Reanimation, Çukurova University, Adana, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2022.110797']
944,35490744,"Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial.","BACKGROUND


Treatment options are limited for skin disease in dermatomyositis. Lenabasum is a cannabinoid receptor type 2 agonist that triggers the resolution of inflammation.
OBJECTIVE


The objective of this study was to evaluate the safety and efficacy of lenabasum in patients with refractory cutaneous dermatomyositis.
DESIGN


This study was a single-center, double-blind, randomized, placebo-controlled phase 2 study conducted from July 2015 to August 2017.
POPULATION


The population included subjects aged ≥18 years with at least moderately active dermatomyositis skin activity by Cutaneous Dermatomyositis Disease Area and Severity Index activity ≥ 14 and failure or intolerance to hydroxychloroquine.
INTERVENTION


Participants received 20 mg lenabasum daily for 28 days and then 20 mg twice per day for 56 days or placebo.
MAIN OUTCOMES AND MEASURES


The primary outcome was a change in Cutaneous Dermatomyositis Disease Area and Severity Index activity. Safety and other secondary efficacy assessments were performed till day 113.
RESULTS


A total of 22 subjects were randomized to lenabasum (n = 11) or placebo (n = 11). No serious or severe adverse events were related to lenabasum, and no participants discontinued the study. The adjusted least-squares mean for Cutaneous Dermatomyositis Disease Area and Severity Index activity decreased more for lenabasum, and the difference was significant on day 113 (least-squares mean [standard error] difference = ‒6.5 [3.1], P = 0.038). Numerically greater improvements were seen in multiple secondary efficacy outcomes and biomarkers with lenabasum.
CONCLUSION


Lenabasum treatment was well tolerated and was associated with greater improvement in Cutaneous Dermatomyositis Disease Area and Severity Index activity and multiple efficacy outcomes.
TRIAL REGISTRATION


This study was registered at ClinicalTrials.gov, NCT02466243.",2022,"(least squares mean [SE] difference -6.5 [3.1], p = 0.038).","['skin disease in dermatomyositis (DM', 'controlled Phase 2 study conducted from July 2015 to August 2017', 'Subjects ≥ 18 years of age with at least moderately active DM skin activity by Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity ≥ 14 and failure or intolerance to hydroxychloroquine', 'Dermatomyositis Patients with Refractory Skin Disease', '22 subjects', 'patients with refractory cutaneous DM']","['placebo', 'Lenabasum, a Cannabinoid Receptor Type 2 Agonist', 'lenabasum 20 mg daily', 'lenabasum']","['CDASI activity', 'change in CDASI activity', 'No serious or severe adverse events (AEs', 'safety and efficacy', 'CDASI activity and multiple efficacy outcomes']","[{'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0011633', 'cui_str': 'Dermatomyositis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0011633', 'cui_str': 'Dermatomyositis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",22.0,0.529084,"(least squares mean [SE] difference -6.5 [3.1], p = 0.038).","[{'ForeName': 'Victoria P', 'Initials': 'VP', 'LastName': 'Werth', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA. Electronic address: werth@pennmedicine.upenn.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hejazi', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Pena', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Haber', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Zeidi', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nithin', 'Initials': 'N', 'LastName': 'Reddy', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Okawa', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Muhammad M', 'Initials': 'MM', 'LastName': 'Bashir', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kirubel', 'Initials': 'K', 'LastName': 'Gebre', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Arvin S', 'Initials': 'AS', 'LastName': 'Jadoo', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Josef Symon S', 'Initials': 'JSS', 'LastName': 'Concha', 'Affiliation': 'Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center, U.S. Department of Veterans Affairs, Philadelphia, Pennsylvania, USA; Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Dgetluck', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Constantine', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'White', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts, USA.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2022.03.029']
945,35499216,Safety and efficacy of telitacicept in refractory childhood-onset systemic lupus erythematosus: A self-controlled before-after trial.,"OBJECTIVE


To observe the efficacy and safety of telitacicept in refractory childhood-onset systemic lupus erythematosus (cSLE).
METHODS


A self-controlled before-after trial. Children with active SLE, aged 5-18 years, who cannot tolerate side effects of glucocorticoid, were enrolled in our study. Patients received subcutaneous injection of telitacicept weekly based on the standard treatment. SLE responder index-4 (SRI-4) was assessed before the first administration and at least 4 weeks after the first administration.
RESULTS


Among the 15 cases of refractory cSLE, three were males (20%) and 12 were females (80%). The median age and weight were 13 years old and 52 kg, respectively. The median duration of disease was 30 months. 5-26 weeks (80 or 160 mg per week) after administration of telitacicept, 66.7% ( n =10) reached SRI-4 response. 12 cases reduced their glucocorticoid intake from 40 mg/d to 17.5 mg/d. The urinary protein after treatment declined in 8 cases whose 24-h proteinuria was >0.5 g at baseline. The urinary protein in two of the eight cases turned negative and plasma albumin in five of the eight cases rose to normal. In addition, three of these eight cases demonstrated varying degrees of improvement in renal impairment, whose estimated glomerular filtration rate (eGFR, ml/min·1.73 m 2 ) rose from 17.4 to 26.6, 40.7 to 48.2, and 63.2 to 146.0, respectively. There were mild to moderate adverse events after treatment.
CONCLUSION


Telitacicept combined with the standard treatment may significantly increase the SRI-4 response rate and reduce the glucocorticoid dosage in refractory cSLE, and also shown efficacy on lupus nephritis. The related adverse drug events were controllable.",2022,The urinary protein in two of the eight cases turned negative and plasma albumin in five of the eight cases rose to normal.,"['refractory childhood-onset systemic lupus erythematosus', 'Children with active SLE, aged 5-18 years, who cannot tolerate side effects of glucocorticoid, were enrolled in our study', '15 cases of refractory cSLE, three were males (20%) and 12 were females (80']","['telitacicept', 'subcutaneous injection of telitacicept']","['negative and plasma albumin', 'median age and weight', 'urinary protein', 'glomerular filtration rate', 'moderate adverse events', 'SRI-4 response rate', 'glucocorticoid intake', 'SRI-4 response', 'SLE responder index-4 (SRI-4', 'efficacy and safety', 'median duration of disease', 'renal impairment', 'Safety and efficacy']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1513374', 'cui_str': 'Common terminology criteria for adverse events grade 2'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",,0.0889549,The urinary protein in two of the eight cases turned negative and plasma albumin in five of the eight cases rose to normal.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ""Department of Rheumatology, 145601Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': ""Department of Nephrology, 145601Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.""}, {'ForeName': 'Yinv', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ""Department of Rheumatology, 145601Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.""}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Rheumatology, 145601Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.""}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': ""Department of Rheumatology, 145601Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.""}, {'ForeName': 'Haimei', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Rheumatology, 145601Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': ""Department of Nephrology, 159388Children's Hospital of Nanjing Medical University, Jiangsu, China.""}, {'ForeName': 'Haiguo', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Rheumatology and Immunology, 159388Children's Hospital of Nanjing Medical University, Jiangsu, China.""}, {'ForeName': 'Lingzhi', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': ""Department of Rheumatology and Immunology, 159388Children's Hospital of Nanjing Medical University, Jiangsu, China.""}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology and Rheumatology, 71532Children's Hospital of Soochow University, Jiangsu, China.""}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Rheumatology, Children's Hospital of Fudan University Anhui Hospital, Anhui, China.""}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Rheumatology, Children's Hospital of Fudan University Anhui Hospital, Anhui, China.""}, {'ForeName': 'Zhiquan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Nephrology and Rheumatology, Children's Hospital of Fudan University at Hainan, Hainan, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Rheumatology, 145601Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.""}]",Lupus,['10.1177/09612033221097812']
946,35500536,"Safety, tolerability and pharmacokinetics of the oligomer modulator anle138b with exposure levels sufficient for therapeutic efficacy in a murine Parkinson model: A randomised, double-blind, placebo-controlled phase 1a trial.","BACKGROUND


Synucleinopathies such as Parkinson ́s disease (PD), Dementia with Lewy bodies (DLB) and Multiple System Atrophy (MSA) are characterized by deposition of misfolded and aggregated α-synuclein. Small aggregates (oligomers) of α-synuclein have been shown to be the most relevant neurotoxic species and are targeted by anle138b, an orally bioavailable small molecule compound which shows strong disease-modifying effects in animal models of synucleinopathies.
METHODS


Anle138b was studied in a single-centre, double-blind, randomised, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy subjects. Eligible participants were randomly assigned (1:1 for sentinel subjects and 1:5 for main group) to placebo or anle138b (dose range 50 mg to 300 mg per day), respectively. In addition, the effect of food on the pharmakokinetics of anle138b in healthy subjects was examined in doses of 150 mg per day. Participants were randomized to treatment sequence (fed→fasted) or (fasted→fed). Treatment was administered orally in hard gelatine capsules containing either 10 mg or 30 mg of anle138b or excipient only. The primary endpoints were safety and tolerability, the secondary endpoint was pharmakokinetics. Data from all randomized individuals were evaluated.
CLINICALTRIALS


gov-identifier: NCT04208152. EudraCT-number: 2019-004218-33.
FINDINGS


Between December 17 th , 2019 and June 27 th , 2020 196 healthy volunteers were screened and 68 participants were enrolled. Of these, all completed the study per protocol. There were no major protocol deviations. Adverse events in this healthy volunteer trial were mostly mild and all fully recovered or resolved prior to discharge. From baseline to completion of the trial no medically significant individual changes were observed in any system organ class. Already at multiple doses of 200 mg, exposure levels above the fully effective exposure in the MI2 mouse Parkinson model were observed.
INTERPRETATION


The favourable safety and PK profile of anle138b in doses resulting in exposures above the fully effective plasma level in a mouse Parkinson model warrant further clinical trials in patients with synucleinopathies.
FUNDING


This study was funded by MODAG GmbH and by the Michael J. Fox foundation for Parkinson's Research.",2022,From baseline to completion of the trial no medically significant individual changes were observed in any system organ class.,"['Between December 17 th , 2019 and June 27 th , 2020 196 healthy volunteers were screened and 68 participants were enrolled', 'murine Parkinson model', 'Eligible participants', 'healthy subjects', 'patients with synucleinopathies']","['placebo', 'placebo or anle138b', 'placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD']","['Safety, tolerability and pharmacokinetics', 'safety and tolerability', 'Adverse events']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026809', 'cui_str': 'Mus'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191670', 'cui_str': 'Synucleinopathy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3883891', 'cui_str': '3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1H-pyrazole'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",196.0,0.393138,From baseline to completion of the trial no medically significant individual changes were observed in any system organ class.,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'MODAG GmbH, Wendelsheim, Germany; Munich Cluster for Systems Neurology (SyNergy), Munich, Germany.; Department of Neurology, Ludwig-Maximilians-University Munich, Germany. Electronic address: levin@modag.net.'}, {'ForeName': 'Nand', 'Initials': 'N', 'LastName': 'Sing', 'Affiliation': 'Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham NG11 6JS, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Melbourne', 'Affiliation': 'Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham NG11 6JS, UK.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham NG11 6JS, UK.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Mariner', 'Affiliation': 'Quotient Sciences, Mere Way, Ruddington Fields, Ruddington, Nottingham NG11 6JS, UK.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Spillantini', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, The Clifford Allbutt Building, Cambridge, CB2 0AH, UK.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wegrzynowicz', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, The Clifford Allbutt Building, Cambridge, CB2 0AH, UK.; Laboratory of Molecular Basis of Neurodegeneration, Mossakowski Medical Research Institute, Polish Academy of Sciences, Warsaw, Poland.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Dalley', 'Affiliation': ""Department of Psychology, University of Cambridge, Downing Street, Cambridge CB2 3EB, UK; Department of Psychiatry, Hershel Smith Building for Brain and Mind Sciences, Addenbrooke's Hospital, Cambridge CB2 0SZ.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Langer', 'Affiliation': 'Department of Psychology, University of Cambridge, Downing Street, Cambridge CB2 3EB, UK.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Ryazanov', 'Affiliation': 'MODAG GmbH, Wendelsheim, Germany; Department of NMR based structural Biology, Max Planck Institute for Biophysical Chemistry, 37077, Göttingen, Germany.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Leonov', 'Affiliation': 'MODAG GmbH, Wendelsheim, Germany; Department of NMR based structural Biology, Max Planck Institute for Biophysical Chemistry, 37077, Göttingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Griesinger', 'Affiliation': 'Department of NMR based structural Biology, Max Planck Institute for Biophysical Chemistry, 37077, Göttingen, Germany; Cluster of Excellence ""Multiscale Bioimaging: From Molecular Machines to Networks of Excitable Cells"" (MBExC), University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Schmidt', 'Affiliation': 'MODAG GmbH, Wendelsheim, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weckbecker', 'Affiliation': 'MODAG GmbH, Wendelsheim, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Prager', 'Affiliation': 'MODAG GmbH, Wendelsheim, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Matthias', 'Affiliation': 'MODAG GmbH, Wendelsheim, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Giese', 'Affiliation': 'MODAG GmbH, Wendelsheim, Germany; Center for Neuropathology and Prion Research, Ludwig-Maximilians-University Munich, Germany. Electronic address: giese@modag.net.'}]",EBioMedicine,['10.1016/j.ebiom.2022.104021']
947,35501349,Efficacy of 0.01% low dose atropine and its correlation with various factors in myopia control in the Indian population.,"We aimed to evaluate the efficacy and safety of low-dose atropine compared to placebo in the Indian population and also to study the impact of various modifiable and non-modifiable factors on myopia progression (MP) and drug efficacy (DE). It was a single-centre prospective placebo-controlled interventional study. 43 participants aged 6-16 years with progressive myopia received 0.01% atropine in the right eyes (treatment) and placebo in the left eyes (control) for 1-year. The main outcome measures were annual MP and axial length elongation (ALE) in treatment and control eyes and their percentage difference between two eyes (drug efficacy). Secondary outcome measures were the occurrence of any adverse events and the correlation of MP, ALE, and DE with various factors. 40 participants (80 eyes) completed the follow-up. After 1-year, MP was 0.25 D (IQR 0.13-0.44) and 0.69 D (IQR 0.50-1.0) (p < 0.001) in treatment and control respectively (63.89% reduction) with respective ALE of 0.14 mm (IQR 0.05-0.35) and 0.32 mm (IQR 0.19-0.46) (p < 0.001) (44.44% reduction). No adverse events were noted. Reduction in MP and ALE was statistically significant in all children irrespective of age-group, baseline MP, family history, screen-time, near and outdoor-time. The strongest determinants of annual MP were age (Treatment: r = - 0.418, p = 0.007; Control: r = - 0.452, p = 0.003) and baseline MP (Treatment: r = 0.64, p = 0.000; Control: r = 0.79, p = 0.000). Screen-time in control eyes was associated with greater ALE (r = 0.620, p = 0.042). DE was higher when outdoor time exceeded 2 h/day (p = 0.035) while the efficacy was lower with prolonged near activities (p = 0.03), baseline fast-progressors (p < 0.05) and history of parental myopia (p < 0.05). 0.01% atropine is effective and safe in retarding MP and ALE in Indian eyes.",2022,"Reduction in MP and ALE was statistically significant in all children irrespective of age-group, baseline MP, family history, screen-time, near and outdoor-time.","['Indian eyes', 'myopia control in the Indian population', '43 participants aged 6-16\xa0years with progressive myopia received 0.01', '40 participants (80 eyes) completed the follow-up']","['placebo', 'atropine']","['annual MP and axial length elongation (ALE', 'myopia progression (MP) and drug efficacy (DE', 'occurrence of any adverse events and the correlation of MP, ALE, and DE with various factors', 'adverse events', 'DE', 'Reduction in MP and ALE', 'history of parental myopia', 'efficacy and safety', 'effective and safe in retarding MP and ALE']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1449744', 'cui_str': 'Myopia, Progressive'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521111', 'cui_str': 'Retarded'}]",43.0,0.0949,"Reduction in MP and ALE was statistically significant in all children irrespective of age-group, baseline MP, family history, screen-time, near and outdoor-time.","[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Chaurasia', 'Affiliation': 'Department of Ophthalmology, Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India. shweta84omns@yahoo.com.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Negi', 'Affiliation': 'Department of Ophthalmology, Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'National Institute of Nursing Education, PGIMER, Chandigarh, India.'}, {'ForeName': 'Srishti', 'Initials': 'S', 'LastName': 'Raj', 'Affiliation': 'Department of Ophthalmology, Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.'}, {'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Kaushik', 'Affiliation': 'Department of Ophthalmology, Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.'}, {'ForeName': 'Rahul Khanna M', 'Initials': 'RKM', 'LastName': 'Optom', 'Affiliation': 'Department of Optometry, Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Kishore', 'Affiliation': 'Centre of Sustainable Built Environment, MSAP, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Mangat Ram', 'Initials': 'MR', 'LastName': 'Dogra', 'Affiliation': 'Department of Ophthalmology, Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.'}]",Scientific reports,['10.1038/s41598-022-10079-1']
948,35502595,"Complete recovery of quadriceps muscle peripheral fatigue after running in Olympic, but not Sprint, triathlon.","This study compared central and peripheral fatigue development between the Sprint and Olympic distance triathlon. Fifteen male triathletes performed Sprint and Olympic triathlon simulations in a randomized and counterbalanced order. Central and peripheral fatigue was evaluated from changes in voluntary activation level (VAL) and twitch responses of quadriceps muscle (Q tw,pot ), respectively. Q tw,pot  reduced from baseline to post-swimming similarly between triathlon simulations (Sprint,-17 ± 11%; Olympic, -13 ± 9%). In post-cycling, Q tw,pot  further declined to a similar extent between triathlon distances (Sprint, -31 ± 15%; Olympic, -28 ± 11%). In post-running, Q tw,pot  was fully recovered in the Olympic triathlon (-4 ± 10%), whereas there was only a partial recovery of Q tw,pot  in the Sprint triathlon (-20 ± 11%). VAL was not reduced in post-swimming, but reduction was similar between triathlon distances in post-cycling (Sprint, -10 ± 9%; Olympic, -8 ± 8%) and post-running (Sprint, -15 ± 14%; Olympic, -16 ± 8%). In the Sprint triathlon, the swimming speed (1.07 ± 0.13m.s -1 ) was above ( p   < .001) critical speed (1.01 ± 0.14m.s -1 ), the cycling power (179.7 ± 27.2W) was below the respiratory compensation point (216.3 ± 27.8W,  p   < .001) and running speed (13.7 ± 1.05km.h -1 ) similar to the respiratory compensation point (13.2 ± 0.70km.h -1 ,  p   = .124). In the Olympic triathlon, swimming speed (1.03 ± 0.13m.s -1 ) was similar to critical speed ( p   = .392), and cycling power (165.3 ± 27.3W) and running speed (12.6 ± 1.05km.h -1 ) were below the respiratory compensation point ( p   ≤ .007). In conclusion, peripheral fatigue progressed until post-cycling regardless of triathlon distances. However, peripheral fatigue was fully recovered after running in Olympic but not in Sprint triathlon. The central fatigue started in post-cycling and progressed until post-running regardless of triathlon distances. HighlightsThe quadriceps muscle peripheral fatigue progresses similarly in Sprint and Olympic triathlons until post-cycling.The quadriceps muscle peripheral fatigue is completely recovered after running in the Olympic triathlon, whereas it is partially recovered in the Sprint triathlon.The central fatigue starts in post-cycling and progresses similarly until post-running in Sprint and Olympic triathlons, regardless of triathlon distances.",2022,"In Sprint triathlon, the swimming speed (1.07 ± 0.13 m ·s -1 ) was above (p < .001) critical speed (1.01 ± 0.14 m ·s -1 ), the cycling power (179.7 ± 27.2W) was below the respiratory compensation point (216.3 ± 27.8W, p < .001) and running speed (13.7 ± 1.05km·h -1 ) similar to the respiratory compensation point (13.2 ± 0.70 km·h -1 , p = .124).",['Fifteen male triathletes performed'],['Sprint and Olympic triathlon simulations'],"['peripheral fatigue', 'voluntary activation level (VAL) and twitch responses of quadriceps muscle', 'VAL', 'swimming speed', 'Central and peripheral fatigue', 'quadriceps muscle peripheral fatigue']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",[],"[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",15.0,0.0903666,"In Sprint triathlon, the swimming speed (1.07 ± 0.13 m ·s -1 ) was above (p < .001) critical speed (1.01 ± 0.14 m ·s -1 ), the cycling power (179.7 ± 27.2W) was below the respiratory compensation point (216.3 ± 27.8W, p < .001) and running speed (13.7 ± 1.05km·h -1 ) similar to the respiratory compensation point (13.2 ± 0.70 km·h -1 , p = .124).","[{'ForeName': 'Vinicius Ferreira Dos Santos', 'Initials': 'VFDS', 'LastName': 'Andrade', 'Affiliation': 'Department of Physical Education, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Luana Loss', 'Initials': 'LL', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Caroline Kêmela Da', 'Initials': 'CKD', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Education, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'John Jairo Villarejo', 'Initials': 'JJV', 'LastName': 'Mayor', 'Affiliation': 'Department of Physical Education, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'André Luiz Félix', 'Initials': 'ALF', 'LastName': 'Rodacki', 'Affiliation': 'Department of Physical Education, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Adriano E', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Department of Physical Education, Federal University of Parana (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Gleber', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Education, Federal University of Parana (UFPR), Curitiba, Brazil.'}]",European journal of sport science,['10.1080/17461391.2022.2072772']
949,35514277,"The effects of exercises with a Pilates ball on balance, reaction time and dual-task performance of kindergarten children.","Aim:  This study investigated the effects of exercises conducted with a Pilates ball on the motor skills of preschool children.  Methods:  62 preschool children were randomly divided into two groups: an intervention group (IG) (n = 30) and a control group (CG) (n = 32). Exercises with a Pilates ball were practiced in IG. The One Leg Standing test, Functional Reach test, Ruler Drop test and Timed-Up and Go test were the outcome measures.  Results:  Static balance performance and dual-task performance were found to be significantly improved in the intragroup and intergroup comparisons, favoring the IG (p < 0.05).  Conclusion:  The exercises carried out in this study were found to be effective on static balance and dual-task performance. The study can guide an exercise program for the preschool age group. Clinical Trial Registration: NCT04575441 (ClinicalTrials.gov).",2022,"Results:  Static balance performance and dual-task performance were found to be significantly improved in the intragroup and intergroup comparisons, favoring the IG (p < 0.05).  ","['preschool children', 'kindergarten children', 'preschool age group', '62\xa0preschool children']","['Exercises with a Pilates ball were practiced in IG', 'exercises with a\xa0Pilates ball', 'control group (CG', 'exercises conducted with a Pilates ball']","['Leg Standing test, Functional Reach test, Ruler Drop test and Timed-Up and Go test', 'Static balance performance and dual-task performance', 'static balance and dual-task performance', 'balance, reaction time and dual-task performance']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0617954,"Results:  Static balance performance and dual-task performance were found to be significantly improved in the intragroup and intergroup comparisons, favoring the IG (p < 0.05).  ","[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Obuz', 'Affiliation': 'Department of Physiotherapy & Rehabilitation, Faculty of Health Sciences, Eastern Mediterranean University, Famagusta, 99628, Cyprus.'}, {'ForeName': 'Zehra Güçhan', 'Initials': 'ZG', 'LastName': 'Topcu', 'Affiliation': 'Department of Physiotherapy & Rehabilitation, Faculty of Health Sciences, Eastern Mediterranean University, Famagusta, 99628, Cyprus.'}]",Journal of comparative effectiveness research,['10.2217/cer-2021-0293']
950,35523395,"The effectiveness and safety of Chaiqin Qingning Capsule in upper respiratory tract infections with fever: A prospective, double-blinded, randomized, multicenter controlled trial.","BACKGROUND AND AIM


Presently, over-the-counter drugs that can treat upper respiratory tract infections (URTI) are rarely effective and safe. Chaiqin Qingning Capsule (CQQNC), a Chinese patent medicine, which has been verified by long-term clinical practice is recommended by Chinese experts for the treatment of URTI with fever. This study conducted a prospective, double-blinded, randomized, multicenter controlled trial to evaluate the effectiveness and safety of CQQNC in the treatment of URTI.
METHODS


The study was conducted at 4 clinical centers in China. Eligible subjects were recruited and randomized 1:1 to the CQQNC group and Qingkailing Capsule (QKLC) group. Both groups were administered orally three times a day for three consecutive days. Primary outcomes were the antipyretic onset time and the temperature recovery time. Secondary outcomes included the symptom disappearance rate, symptom score, and drug safety assessment.
RESULTS


A total of 269 subjects were analyzed (134 subjects in the CQQNC group, 135 subjects in the QKLC group). The antipyretic onset time and the temperature recovery time were significantly shortened in the CQQNC group (median: 5 h vs. 10 h, p < 0.0001, median: 19 h vs. 27 h, p < 0.0001). CQQNC was more effective than the QKLC in improving the symptoms of pharyngodynia and rhinobyon (85.07% vs. 71.11%, p = 0.008; 76.99% vs. 64.41%, p = 0.043), and in improving the overall symptom scores (-15.10 ± 3.23 vs. -13.35 ± 3.58, p < 0.0001). During the trial, no serious adverse events were reported in the two groups.
CONCLUSION


CQQNC is effective and safe in the treatment of URTI with fever, and worthy of clinical application. (http://www.chictr.org.cn, ChiCTR-IPR-16009049).",2022,"CQQNC was more effective than the QKLC in improving the symptoms of pharyngodynia and rhinobyon (85.07% vs. 71.11%, p = 0.008; 76.99% vs. 64.41%, p = 0.043), and in improving the overall symptom scores (-15.10 ± 3.23 vs. -13.35 ± 3.58, p < 0.0001).","['Upper Respiratory Tract Infections with Fever', 'Eligible subjects', '4 clinical centers in China', '269 subjects were analyzed (134 subjects in the CQQNC group, 135 subjects in the QKLC group']","['QKLC', 'CQQNC group and Qingkailing Capsule (QKLC', 'CQQNC', 'Chaiqin Qingning Capsule', 'Chaiqin Qingning Capsule (CQQNC']","['symptoms of pharyngodynia and rhinobyon', 'symptom disappearance rate, symptom score, and drug safety assessment', 'overall symptom scores', 'antipyretic onset time and the temperature recovery time']","[{'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C1620239', 'cui_str': 'Qingkailing'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1620239', 'cui_str': 'Qingkailing'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3854543', 'cui_str': 'Pharyngodynia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",269.0,0.230788,"CQQNC was more effective than the QKLC in improving the symptoms of pharyngodynia and rhinobyon (85.07% vs. 71.11%, p = 0.008; 76.99% vs. 64.41%, p = 0.043), and in improving the overall symptom scores (-15.10 ± 3.23 vs. -13.35 ± 3.58, p < 0.0001).","[{'ForeName': 'Xiangru', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Pu', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China. Electronic address: zhoushuang8008@163.com.'}, {'ForeName': 'Bangjiang', 'Initials': 'B', 'LastName': 'Fang', 'Affiliation': 'Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China; Institute of Emergency and Critical Care Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.. Electronic address: fangbji@163.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2022.102840']
951,35525971,"Comparison of the effects of Tai Chi and general aerobic exercise on weight, blood pressure and glycemic control among older persons with depressive symptoms: a randomized trial.","BACKGROUND


Blood pressure and glycemic control are associated with the management of depressive symptoms in patients with depression. Previous studies have demonstrated that both Tai Chi and aerobic exercise have positive effects on blood pressure and glycemic control. Few studies have compared the physiological effects of Tai Chi versus aerobic exercise in older adults with depressive symptoms. The objective of this study was to compare the effects of Tai Chi and aerobic exercise on weight, body mass index, blood pressure and glycosylated hemoglobin (HbA1c) level in older persons with mild to moderate-severe depressive symptoms.
METHODS


A randomized controlled trial was performed. The older persons (age ≥ 60 years old) with depressive symptoms were recruited. Then, participants were randomly allocated to the Tai Chi group and the aerobic exercise group received a 12-week 24-movement Yang's Tai Chi intervention and aerobic exercise, respectively. Data collection occurred at baseline and after completion of the interventions (week 12).
RESULTS


A total of 238 participants with mild to moderate-to-severe depressive symptoms were included in the final analysis, including 120 in the Tai Chi group and 118 in the aerobic exercise group. The difference in weight and body mass index in the Tai Chi group was 2.0 kg (Z = -4.930, P < 0.001) and 0.77 kg/m 2  (Z = -5.046, P < 0.001) higher than that in the aerobic exercise group, respectively. After the 12-week intervention, the systolic pressure and diastolic pressure in the Tai Chi group were 5.50 mmHg (Z = -2.282, P = 0.022) and 8.0 mmHg (Z = -3.360, P = 0.001) lower than that in the aerobic exercise group, respectively. The difference in HbA1c level in the Tai Chi group was 0.50% higher than that in the aerobic exercise group (Z = -4.446, P < 0.001).
CONCLUSION


This study showed that Tai Chi exercise was more effective in improving blood pressure and HbA1c level than general aerobic exercise. It suggested that Tai Chi might be an effective approach for the management of blood pressure and long-term glucose control in older persons with depressive symptoms.
TRIAL REGISTRATION


Trial registration: ChiCTR, ChiCTR2100042534 . Registration date: 23/01/2021, http://www.chictr.org.cn/showproj.aspx?proj=120602 .",2022,"The difference in HbA1c level in the Tai Chi group was 0.50% higher than that in the aerobic exercise group (Z = -4.446, P < 0.001).
","['older adults with depressive symptoms', 'older persons with depressive symptoms', '238 participants with mild to moderate-to-severe depressive symptoms were included in the final analysis, including 120 in the Tai Chi group and 118 in the aerobic exercise group', 'patients with depression', 'older persons (age\u2009≥\u200960\xa0years old) with depressive symptoms were recruited', 'older persons with mild to moderate-severe depressive symptoms']","['Tai Chi exercise', 'aerobic exercise', 'Tai Chi and aerobic exercise', 'Tai Chi and general aerobic exercise', ""Tai Chi group and the aerobic exercise group received a 12-week 24-movement Yang's Tai Chi intervention and aerobic exercise"", 'Tai Chi versus aerobic exercise']","['blood pressure and HbA1c level', 'weight, blood pressure and glycemic control', 'systolic pressure and diastolic pressure', 'blood pressure and glycemic control', 'HbA1c level', 'weight, body mass index, blood pressure and glycosylated hemoglobin (HbA1c) level', 'blood pressure', 'weight and body mass index']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",238.0,0.0214336,"The difference in HbA1c level in the Tai Chi group was 0.50% higher than that in the aerobic exercise group (Z = -4.446, P < 0.001).
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, West China Second University Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Biru', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': 'Department of Nursing, West China Second University Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The People's Hospital of Jiawang District of Xuzhou, Xuzhou, 221011, China.""}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Ya' an Polytechnic College, Ya' an, 625100, China.""}, {'ForeName': 'Shujuan', 'Initials': 'S', 'LastName': 'Liao', 'Affiliation': 'Department of Nursing, West China Second University Hospital, Sichuan University, Chengdu, 610041, China. liao_shujuan@163.com.'}]",BMC geriatrics,['10.1186/s12877-022-03084-6']
952,35525865,A randomized controlled trial of the effects of whole grains versus refined grains diets on the microbiome in pregnancy.,"Dietary whole grain consumption has been postulated to have metabolic benefits. The purpose of this study was to compare a pregnancy diet containing 75% of total carbohydrates as refined grains with a diet of 75% of total carbohydrates as whole grains for pregnancy outcomes and effects on the microbiome. Gestational weight gain, glucose tolerance and newborn outcomes were measured on 248 enrolled compliant women from whom a subset of 103 women consented to give 108 vaginal and 109 anal swabs. The data presented here are limited to the patients from whom the vaginal and anal swabs were obtained in order to study the microbiome. A microbiome-16SrRNA survey-was characterized in these samples. Samples and measurements were obtained at the first obstetrical visit, before beginning a prescribed diet (T1-baseline) and after 17-32 weeks on the prescribed diet (T3). Food frequency questionnaires and total plasma alkylresorcinols were used as a measure of whole grain consumption. There were no dietary differences in maternal weight gain, birth weight, or glucose tolerance test. Mothers consuming the whole grains diet showed a trend of gestational decrease in vaginal bacterial alpha diversity, with increasing Lactobacillus-dominance. No significant difference was observed for the anal microbiome. The results suggest that diet modulations of the vaginal microbiome during gestation may have important implications for maternal and neonatal health and in the intergenerational transfer of maternal microbiome. Trial registration: ClinicalTrials.gov Identifier: NCT03232762.",2022,"Mothers consuming the whole grains diet showed a trend of gestational decrease in vaginal bacterial alpha diversity, with increasing Lactobacillus-dominance.",['248 enrolled compliant women from whom a subset of 103 women consented to give 108 vaginal and 109 anal swabs'],"['whole grains versus refined grains diets', 'pregnancy diet containing 75% of total carbohydrates as refined grains with a diet of 75% of total carbohydrates as whole grains']","['vaginal bacterial alpha diversity', 'Food frequency questionnaires and total plasma alkylresorcinols', 'maternal weight gain, birth weight, or glucose tolerance test', 'anal microbiome', 'Gestational weight gain, glucose tolerance and newborn outcomes']","[{'cui': 'C0566588', 'cui_str': 'Compliant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0444214', 'cui_str': 'Anal swab'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",248.0,0.0344934,"Mothers consuming the whole grains diet showed a trend of gestational decrease in vaginal bacterial alpha diversity, with increasing Lactobacillus-dominance.","[{'ForeName': 'Haipeng', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Biochemistry and Microbiology, Rutgers University, New Brunswick, USA.'}, {'ForeName': 'Pamella', 'Initials': 'P', 'LastName': 'Yamada', 'Affiliation': 'Department of Obstetrics and Gynecology, New York University Langone Health, 462 First Avenue, Building D, Room 572, New York, NY, 10016, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Paetow', 'Affiliation': 'Department of Obstetrics and Gynecology, New York University Langone Health, 462 First Avenue, Building D, Room 572, New York, NY, 10016, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chan', 'Affiliation': 'Department of Obstetrics and Gynecology, New York University Langone Health, 462 First Avenue, Building D, Room 572, New York, NY, 10016, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Arslan', 'Affiliation': 'Department of Obstetrics and Gynecology, New York University Langone Health, 462 First Avenue, Building D, Room 572, New York, NY, 10016, USA.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Division of Food and Nutrition Science (RL), Department of Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Maria Gloria', 'Initials': 'MG', 'LastName': 'Dominguez-Bello', 'Affiliation': 'Department of Biochemistry and Microbiology, Rutgers University, New Brunswick, USA.'}, {'ForeName': 'Bruce K', 'Initials': 'BK', 'LastName': 'Young', 'Affiliation': 'Department of Obstetrics and Gynecology, New York University Langone Health, 462 First Avenue, Building D, Room 572, New York, NY, 10016, USA. Bruce.Young@nyulangone.org.'}]",Scientific reports,['10.1038/s41598-022-11571-4']
953,35527585,Combined effects of cerebellar tDCS and task-oriented circuit training in people with multiple sclerosis: A pilot randomized control trial.,"BACKGROUND


Balance and mobility impairments are frequent in people with multiple sclerosis, partly due to cerebellar dysfunctions. Task-oriented behavioural approaches were previously shown to promote physical function. The possibility exists that cerebellar transcranial direct current stimulation (ctDCS) applied during training, known to increase the excitability of the brain, can boost rehabilitation effects through modulation of cerebellum-brain inhibition.
OBJECTIVE


To test the efficacy of cerebellar ctDCS stimulation combined with motor training on mobility and balance in people with multiple sclerosis.
METHODS


16 subjects were randomly assigned to receive real- or sham-ctDCS and task-oriented training daily over two weeks in a double-blind, randomised clinical pilot trial. Functional mobility, balance, walking performance and quality of life were tested before and after treatment and at two-week follow-up. Effects of cerebellar stimulation on psychological and executive functions were also recorded.
RESULTS


Walking performance, balance and quality of life improved for both groups at post-treatment assessment which was maintained at 2-weeks follow up. A two-way ANOVA revealed a significant time effect for balance and walking performance. A significant interaction effect of time-treatment (F = 3.12, df = 2,26; p = 0.03) was found for motor aspects of quality of life assessment in patients who received real-ctDCS.
CONCLUSIONS


Task-oriented training improves balance and mobility in people with multiple sclerosis, but ctDCS does not boost motor training effects.",2022,"RESULTS


Walking performance, balance and quality of life improved for both groups at post-treatment assessment which was maintained at 2-weeks follow up.","['16 subjects', 'people with multiple sclerosis']","['cerebellar transcranial direct current stimulation (ctDCS', 'cerebellar ctDCS stimulation combined with motor training', 'cerebellar stimulation', 'cerebellar tDCS and task-oriented circuit training', 'real- or sham-ctDCS and task-oriented training daily', 'Task-oriented training']","['mobility and balance', 'Functional mobility, balance, walking performance and quality of life', 'psychological and executive functions', 'Walking performance, balance and quality of life', 'motor aspects of quality of life assessment', 'balance and mobility', 'balance and walking performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}]",16.0,0.0175846,"RESULTS


Walking performance, balance and quality of life improved for both groups at post-treatment assessment which was maintained at 2-weeks follow up.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baroni', 'Affiliation': 'Department of Neuroscience and Rehabilitation, Ferrara University Hospital, Ferrara, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Magro', 'Affiliation': 'Physical Medicine and Rehabilitation School, Department of Neuroscience, University of Padova, Padova, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Martinuzzi', 'Affiliation': 'Department of Neuroscience and Rehabilitation, Ferrara University Hospital, Ferrara, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brondi', 'Affiliation': 'Department of Neuroscience and Rehabilitation, Ferrara University Hospital, Ferrara, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Masiero', 'Affiliation': 'Rehabilitation Unit, Department of Neuroscience, University of Padova, Padova, Italy.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Milani', 'Affiliation': 'Department of Neuroscience and Rehabilitation, Ferrara University Hospital, Ferrara, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Zani', 'Affiliation': 'Department of Neuroscience and Rehabilitation, Ferrara University Hospital, Ferrara, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Bergonzoni', 'Affiliation': 'Department of Neuroscience and Rehabilitation, Ferrara University Hospital, Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neuroscience and Rehabilitation, Ferrara University Hospital, Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neuroscience and Rehabilitation, Ferrara University Hospital, Ferrara, Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-211245']
954,35500264,"In overweight or obesity without diabetes, weekly semaglutide vs. daily liraglutide increased weight loss at 68 wk.","SOURCE CITATION


Rubino DM, Greenway FL, Khalid U, et al.  Effect of weekly subcutaneous semaglutide vs daily liraglutide on body weight in adults with overweight or obesity without diabetes: the STEP 8 randomized clinical trial.  JAMA. 2022;327:138-50. 35015037.",2022,Effect of weekly subcutaneous semaglutide vs daily liraglutide on body weight in adults with overweight or obesity without diabetes: the STEP 8 randomized clinical trial.  ,['adults with overweight or obesity without diabetes'],['subcutaneous semaglutide vs daily liraglutide'],"['body weight', 'weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0998289,Effect of weekly subcutaneous semaglutide vs daily liraglutide on body weight in adults with overweight or obesity without diabetes: the STEP 8 randomized clinical trial.  ,"[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Kauffman', 'Affiliation': 'Texas Tech University School of Medicine, Amarillo, Texas, USA (R.P.K.).'}]",Annals of internal medicine,['10.7326/J22-0023']
955,35500262,"In adults hospitalized with COVID-19, adding remdesivir to standard care did not reduce in-hospital mortality.","SOURCE CITATION


Ali K, Azher T, Baqi M, et al.  Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.  CMAJ. 2022;194:E242-51. 35045989.",2022,Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.  ,['patients in hospital with COVID-19 in Canada'],[],['hospital mortality'],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",,0.174836,Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.  ,"[{'ForeName': 'Kasha P', 'Initials': 'KP', 'LastName': 'Singh', 'Affiliation': 'The Royal Melbourne Hospital and The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia (K.P.S., S.Y.T.).'}, {'ForeName': 'Steven Y C', 'Initials': 'SYC', 'LastName': 'Tong', 'Affiliation': 'The Royal Melbourne Hospital and The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia (K.P.S., S.Y.T.).'}]",Annals of internal medicine,['10.7326/J22-0025']
956,35500260,"In older adults having hip fracture surgery, regional vs. general anesthesia did not reduce postoperative delirium.","SOURCE CITATION


Li T, Li J, Yuan L, et al.  Effect of regional vs general anesthesia on incidence of postoperative delirium in older patients undergoing hip fracture surgery: the RAGA randomized trial.  JAMA. 2022;327:50-8. 34928310.",2022,Effect of regional vs general anesthesia on incidence of postoperative delirium in older patients undergoing hip fracture surgery: the RAGA randomized trial.  ,"['older patients undergoing hip fracture surgery', 'older adults having hip fracture surgery']",['regional vs general anesthesia'],['postoperative delirium'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",,0.113937,Effect of regional vs general anesthesia on incidence of postoperative delirium in older patients undergoing hip fracture surgery: the RAGA randomized trial.  ,"[{'ForeName': 'Sudeep S', 'Initials': 'SS', 'LastName': 'Gill', 'Affiliation': ""Queen's University, Kingston, Ontario, Canada (S.S.G.).""}]",Annals of internal medicine,['10.7326/J22-0027']
957,35500646,"Lung function six months after severe COVID-19: Does time, in fact, heal all wounds?","BACKGROUND


COVID-19 has been associated with persistent symptoms and functional changes, especially in those surviving severe disease.
METHODS


We conducted a prospective multicenter study in patients with severe COVID-19 to determine respiratory sequelae. Patients were stratified into two groups: ward admission (WA) and intensive care unit (ICU) admission. In each follow-up visit, the patients where inquired about cough and dyspnea, and performed spirometry, lung volumes, carbon monoxide diffusion capacity (DLCO), 6-minute walk test (6MWT), and respiratory muscle strength (MIP and MEP). Results of pulmonary function tests at 45 days and 6 months after hospital admission were compared using paired analysis.
RESULTS


211 patients were included, 112 in WA and 99 in ICU. Dyspnea persisted in 64.7% in the WA and 66.7% in the ICU group after 6 months. Lung function measures showed significant improvement between 45 days and 6 months, both in WA and ICU groups in VC, FVC, FEV1, total lung capacity, and 6MW distance measures. The improvement in the proportions of the altered functional parameters was significant in the ICU group for VC (44.2% 45 d; 20.8% 6 m; p = 0,014), FVC (47.6% 45 d; 28% 6 m; p = 0,003), FEV1 (45.1% 45 d; 28% 6 m; p = 0,044), DLCO (33.8% 45 d; 7.7% 6 m; p < 0,0001).
CONCLUSION


Six months follow-up of patients with the severe forms of COVID-19 showed significant improvement in the lung function measures compared to 45 days post hospital discharge. The difference was more evident in those requiring ICU admission.",2022,"Lung function measures showed significant improvement between 45 days and 6 months, both in WA and ICU groups in VC, FVC, FEV1, total lung capacity, 6MW distance measures.","['patients with severe COVID-19 to determine respiratory sequelae', 'Patients were stratified into two groups: ward admission (WA) and intensive care unit (ICU) admission', '211 patients were included, 112 in WA and 99 in ICU']",['ICU'],"['FVC', 'VC, FVC, FEV1, total lung capacity, 6MW distance measures', 'proportions of the altered functional parameters', 'cough, dyspnea, and performed spirometry, lung volumes, carbon monoxide diffusion capacity (DLCO), 6-minute walk test (6MWT), and respiratory muscle strength (MIP and MEP', 'FEV1', 'lung function measures', 'DLCO', 'Dyspnea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0040509', 'cui_str': 'Total lung capacity'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",211.0,0.0327829,"Lung function measures showed significant improvement between 45 days and 6 months, both in WA and ICU groups in VC, FVC, FEV1, total lung capacity, 6MW distance measures.","[{'ForeName': 'Daniel Cruz', 'Initials': 'DC', 'LastName': 'Bretas', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Arnaldo Santos', 'Initials': 'AS', 'LastName': 'Leite', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Eliane Viana', 'Initials': 'EV', 'LastName': 'Mancuzo', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil. Electronic address: elianevmancuzo4@gmail.com.'}, {'ForeName': 'Tarciane Aline', 'Initials': 'TA', 'LastName': 'Prata', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Bruno Horta', 'Initials': 'BH', 'LastName': 'Andrade', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Jacqueline das Graças Ferreira', 'Initials': 'JDGF', 'LastName': 'Oliveira', 'Affiliation': 'Hospital Eduardo de Menezes - Fundação Hospitalar de Minas Gerais (FHEMIG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Aline Priscila', 'Initials': 'AP', 'LastName': 'Batista', 'Affiliation': 'Universidade Federal de Ouro Preto (UFOP), Ouro Preto, MG, Brazil.'}, {'ForeName': 'George Luiz Lins', 'Initials': 'GLL', 'LastName': 'Machado-Coelho', 'Affiliation': 'Universidade Federal de Ouro Preto (UFOP), Ouro Preto, MG, Brazil.'}, {'ForeName': 'Valéria Maria', 'Initials': 'VM', 'LastName': 'Augusto', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Carolina Coimbra', 'Initials': 'CC', 'LastName': 'Marinho', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}]",The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases,['10.1016/j.bjid.2022.102352']
958,35501772,Effect of cognitive behavioral therapy program on mental health status among medical student in Palestine during COVID pandemic.,"BACKGROUND


The COVID-19 pandemic had a profound psychological influence on everyone in society, and the impact it had on students, particularly medical students, cannot be underestimated. The main purpose of this study is to (1) determine the prevalence of mental disorders among medical students and their associated factors, and (2) examine the effectiveness of cognitive behavior therapy on mental health problems among medical students.
METHODS


Between March and May 2021, we conducted a randomized controlled study on two phases among medical students at An-Najah National University. Data were collected using an online questionnaire and the Arabic version of the 12-item General Health Questionnaire (GHQ-12). We also used the MEDAS tool to assess their Mediterranean Diet (MD) adherence. In the second phase, sixty-six students were recruited and assigned randomly to control and intervention groups. Intervention impact was assessed using 12-item General Health Questionnaire at two-time points; baseline, and 8 weeks post-intervention. The interventional model used was cognitive behavioral therapy, and the control group received no treatment.
RESULTS


A total of 329 students were included in the analysis of the first phase of the study. Approximately 28% of students had mental health problems. We found a significant relationship between good mental health status with a higher level of physical activity level, longer sleeping hours, and shorter entertainment time (p < 0.05). In the second phase of the study, a total of 91 students were included. Overall, using the CBT program showed a significant improvement in the outcome measures. At 8 weeks post-intervention, students had lower scores on total GHQ-12, depression, anxiety, and social dysfunction.
CONCLUSION


These findings propose that adequate attention must be paid to the mental health of medical students and that CBT programs can be used for the management of mental health problems among medical students.",2022,"At 8 weeks post-intervention, students had lower scores on total GHQ-12, depression, anxiety, and social dysfunction.
","['Between March and May 2021', 'sixty-six students', 'medical students at An-Najah National University', 'mental health problems among medical students', 'A total of 329 students were included in the analysis of the first phase of the study', 'medical student in Palestine during COVID pandemic', '91 students were included']","['cognitive behavioral therapy\xa0program', 'cognitive behavior therapy']","['total GHQ-12, depression, anxiety, and social dysfunction', 'mental health status', 'Arabic version of the 12-item General Health Questionnaire (GHQ-12', 'Mediterranean Diet (MD) adherence', 'mental health problems', 'physical activity level, longer sleeping hours, and shorter entertainment time', '12-item General Health Questionnaire']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4274135', 'cui_str': '12 item General Health Questionnaire'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",329.0,0.00676924,"At 8 weeks post-intervention, students had lower scores on total GHQ-12, depression, anxiety, and social dysfunction.
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Hanani', 'Affiliation': 'Department of Public Health, Faculty of Medicine and Health Sciences, An-Najah National University, PO. Box 7, Nablus, West Bank, Palestine. a.hanani@najah.edu.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Badrasawi', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture and Veterinary Medicine, An-Najah National University, PO. Box 7, Tulkarm, West Bank, Palestine.'}, {'ForeName': 'Souzan', 'Initials': 'S', 'LastName': 'Zidan', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Hebron University, PO. Box 40, Hebron, West Bank, Palestine.'}, {'ForeName': 'Marah', 'Initials': 'M', 'LastName': 'Hunjul', 'Affiliation': 'Medicine Program, Faculty of Medicine and Health Sciences, An-Najah National University, PO. Box 7, Nablus, West Bank, Palestine.'}]",BMC psychiatry,['10.1186/s12888-022-03915-1']
959,35502773,"Limitations of randomized, controlled, double-blinded studies in determining safety and effectiveness of treatments.","Randomized, controlled, double-blinded studies, in which treated subjects are randomly selected from the same pool as controlled (untreated) ones and neither the caregiver nor the patient knows which is which, are widely accepted as the gold standard of experimental medicine. There are well-documented advantages of such studies. There are, however, significant limitations of them as well of which it is important to be aware. Notably, physicians who rely on experience and on what they were taught in medical school and post-graduate training are not necessarily wrong when this information runs contrary to the results of such studies. Some limitations of them are widely known and taught, such as inadequate sample size, failure of proper randomization, et cetera; others are less well-known. We shall focus on the latter.",2022,"Notably, physicians who rely on experience and on what they were taught in medical school and in postgraduate training are not necessarily wrong when this information runs contrary to the results of such studies.",[],[],[],[],[],[],,0.369985,"Notably, physicians who rely on experience and on what they were taught in medical school and in postgraduate training are not necessarily wrong when this information runs contrary to the results of such studies.","[{'ForeName': 'W Clark', 'Initials': 'WC', 'LastName': 'Lambert', 'Affiliation': 'New Jersey Medical School, Rutgers University, Newark, NJ, USA.'}, {'ForeName': 'Edmund J', 'Initials': 'EJ', 'LastName': 'Janniger', 'Affiliation': 'New Jersey Medical School, Rutgers University, Newark, NJ, USA.'}]",Current medical research and opinion,['10.1080/03007995.2022.2073121']
960,35505312,Findings from a pilot open-label trial of N-acetylcysteine for the treatment of pediatric mania and hypomania.,"BACKGROUND


Pediatric bipolar disorder is a highly prevalent and morbid disorder and is considered a prevalent public health concern. Currently approved treatments often pose the risk of serious side effects. Therefore, this study assessed the efficacy and tolerability of N-acetylcysteine (NAC), in children and adolescents with bipolar spectrum disorder.
METHODS


We conducted a 12-week open-label trial of NAC for treatment of mania and hypomania in children and adolescents ages 5-17 with bipolar spectrum disorder including participants with full and subthreshold manic symptoms, accepting those with and without mixed states with co-occurring depression, and Young Mania Rating Scale scores ≥ 20 and < 40. Symptoms of mania and depression were assessed using the Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scale (HDRS), Children's Depression Rating Scale (CDRS), and Clinical Global Impression (CGI) Severity (CGI-S) and Improvement (CGI-I) scales for mania and depression.
RESULTS


This study had a high drop-out rate with only 53% completing all 12 weeks. There was a significant reduction in YMRS, HDRS, and CDRS mean scores from baseline to endpoint. Of the 24 exposed participants, 54% had an anti-manic response measured by a reduction in YMRS ≥ 30% and 46% had a CGI-I mania score ≤ 2 at endpoint. Additionally, 62% of participants had an anti-depressive response measured by a reduction in HDRS ≥ 30%, 31% had an anti-depressive response measured by a reduction in CDRS ≥ 30%, and 38% had a CGI-I depression score ≤ 2 at endpoint.
CONCLUSIONS


These pilot open-label findings in a small sample provide preliminary data supporting the tolerability and safety of NAC in a pediatric population. The findings of this pilot scale study indicating improvement in mania and depression are promising, but require replication with a monotherapy randomized placebo controlled clinical trial and larger sample.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02357290 . First Registration 06/02/2015.",2022,"There was a significant reduction in YMRS, HDRS, and CDRS mean scores from baseline to endpoint.","['children and adolescents with bipolar spectrum disorder', 'pediatric mania and hypomania', 'children and adolescents ages 5-17 with bipolar spectrum disorder including participants with full and subthreshold manic symptoms, accepting those with and without mixed states with co-occurring depression, and Young Mania Rating Scale scores\u2009≥\u200920 and\u2009<\u200940']","['placebo', 'N-acetylcysteine (NAC', 'NAC', 'N-acetylcysteine']","[""Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scale (HDRS), Children's Depression Rating Scale (CDRS), and Clinical Global Impression (CGI"", 'YMRS, HDRS, and CDRS mean scores', 'anti-depressive response', 'mania and hypomania', 'efficacy and tolerability', 'Symptoms of mania and depression', 'Severity (CGI-S) and Improvement (CGI', 'anti-manic response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",24.0,0.0771686,"There was a significant reduction in YMRS, HDRS, and CDRS mean scores from baseline to endpoint.","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wozniak', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, 55 Fruit St., Warren 705, Boston, MA, USA. jwozniak@partners.org.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'DiSalvo', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, 55 Fruit St., Warren 705, Boston, MA, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Farrell', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, 55 Fruit St., Warren 705, Boston, MA, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Vaudreuil', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, 55 Fruit St., Warren 705, Boston, MA, USA.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Uchida', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, 55 Fruit St., Warren 705, Boston, MA, USA.'}, {'ForeName': 'T Atilla', 'Initials': 'TA', 'LastName': 'Ceranoglu', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, 55 Fruit St., Warren 705, Boston, MA, USA.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Joshi', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, 55 Fruit St., Warren 705, Boston, MA, USA.'}, {'ForeName': 'Emmaline', 'Initials': 'E', 'LastName': 'Cook', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, 55 Fruit St., Warren 705, Boston, MA, USA.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Faraone', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, 55 Fruit St., Warren 705, Boston, MA, USA.'}]",BMC psychiatry,['10.1186/s12888-022-03943-x']
961,35505290,Effect of individually tailored nutritional counselling on protein and energy intake among older people receiving home care at risk of or having malnutrition: a non-randomised intervention study.,"BACKGROUND


With ageing, food intake may decrease and lead to an insufficient nutrient intake causing protein-energy malnutrition (PEM) which is associated with adverse health effects and increased mortality. The aim of this study was to investigate the effects of individually tailored dietary counseling focused on protein intake among home care clients with PEM or at risk of developing PEM. The secondary aim was to study the intake of energy and other nutrients.
METHODS


This intervention study is part of the non-randomised population-based multidisciplinary Nutrition, Oral Health and Medication study (NutOrMed study). The intervention group comprised 112 and the control group 87 home care clients (≥75 years) with PEM or risk of PEM. PEM was defined by Mini Nutritional Assessment score < 24 and/or plasma albumin < 35 g/L. The nutrients intake was assessed from 24-hour dietary recall at the baseline and after the six-month intervention. The intervention consisted of an individually tailored dietary counseling; the persons were instructed to increase their food intake with protein and energy dense food items, the number of meals and consumption of protein-, energy- and nutrient-rich snacks for six months.
RESULTS


After the six-month nutritional intervention, the mean change in protein intake increased 0.04 g/kgBW (95% CI 0.05 to 0.2), fibre 0.8 g (95% CI 0.2 to 4.3), vitamin D 8.5 μg (95% CI 0.7 to 4.4), E 0.6 mg (95% CI 0.4 to 2.2), B12 0.7 μg (95% CI 0.02 to 2.6), folate 8.7 μg (95% CI 1.5 to 46.5), iron 0.4 mg 95% CI 0.6 to 2.4), and zinc 0.5 mg (95% CI 0.6 to 2.2) in the intervention group compared with the control group. The proportion of those receiving less than 1.0 g/kg/BW protein decreased from 67 to 51% in the intervention group and from 84 to 76% in the control group. Among home care clients with a cognitive decline (MMSE< 18), protein intake increased in the intervention group by 0.2 g/kg/BW (p = 0.048) but there was no change in the control group.
CONCLUSION


An individual tailored nutritional intervention improves the intake of protein and other nutrients among vulnerable home care clients with PEM or its risk and in persons with cognitive decline.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT02214758. Date of trial registration: 12/08/2014.",2022,"An individual tailored nutritional intervention improves the intake of protein and other nutrients among vulnerable home care clients with PEM or its risk and in persons with cognitive decline.
","['vulnerable home care clients with PEM or its risk and in persons with cognitive decline', 'home care clients with PEM or at risk of developing PEM', 'older people receiving home care at risk of or having malnutrition']","['control group 87 home care clients (≥75\u2009years) with PEM or risk of PEM', 'individually tailored nutritional counselling', 'individually tailored dietary counseling', 'individually tailored dietary counseling; the persons were instructed to increase their food intake with protein and energy dense food items, the number of meals and consumption of protein-, energy- and nutrient-rich snacks for six months']","['BW protein', 'mean change in protein intake', 'protein and energy intake', 'protein intake']","[{'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0033677', 'cui_str': 'Deficiency of macronutrients'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033677', 'cui_str': 'Deficiency of macronutrients'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0453831', 'cui_str': 'High energy food'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.043013,"An individual tailored nutritional intervention improves the intake of protein and other nutrients among vulnerable home care clients with PEM or its risk and in persons with cognitive decline.
","[{'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Kaipainen', 'Affiliation': 'Kuopio Research Centre of Geriatric Care, School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, P.O.B 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Hartikainen', 'Affiliation': 'Kuopio Research Centre of Geriatric Care, School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, P.O.B 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Tiihonen', 'Affiliation': 'Kuopio Research Centre of Geriatric Care, School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, P.O.B 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Nykänen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, P.O.B 1627, FI-70211, Kuopio, Finland. irma.nykanen@uef.fi.'}]",BMC geriatrics,['10.1186/s12877-022-03088-2']
962,35507955,Effect of  Momordica charantia  Administration on Anthropometric Measures and Metabolic Profile in Patients with Obesity: A Pilot Clinical Trial.,"The aim of this study was to evaluate the effect of  Momordica charantia  (MC) administration on anthropometric measures in patients with obesity. A randomized, double-blind, placebo-controlled pilot clinical trial was carried out in 24 patients with obesity. Twelve patients randomly received MC (2000 mg/day) for 12 weeks, and 12 patients received placebo. Body weight (BW), body mass index (BMI), waist circumference (WC), body fat percentage, as well as clinical and laboratory determinations, were evaluated before and after the intervention. Results showed that while reductions in BW, BMI, WC, and body fat percentage were observed in the MC group, these differences did not reach statistical significance. Significant decreases in triglycerides (TG) (1.9 ± 0.6 mM vs. 1.7 ± 0.7 mM,  P  ≤ .05) and very low-density lipoprotein (VLDL) (0.4 ± 0.1 mM vs. 0.3 ± 0.1 mM,  P  ≤ .05) levels were found after the intervention with MC. In contrast, significant increases in BW (83.0 ± 10.7 kg vs. 84.6 ± 9.1 kg,  P  ≤ .05) and BMI (31.9 ± 1.5 kg/m 2  vs. 33.0 ± 1.3 kg/m 2 ,  P  ≤ .05) were observed in the placebo group. In conclusion, no significant reductions in BW, BMI, WC, and body fat percentage were observed after MC administration; however, MC significantly decreased TG and VLDL levels. The protocol was registered at ClinicalTrials.gov with the identifier NCT04916379.",2022,"Significant decreases in triglycerides (TG) (1.9 ± 0.6 mM vs. 1.7 ± 0.7 mM,  P  ≤ .05) and very low-density lipoprotein (VLDL) (0.4 ± 0.1 mM vs. 0.3 ± 0.1 mM,  P  ≤ .05) levels were found after the intervention with MC.","['Patients with Obesity', '24 patients with obesity', 'patients with obesity']","['placebo', 'Momordica charantia  Administration', 'MC', 'Momordica charantia  (MC']","['triglycerides (TG', 'low-density lipoprotein (VLDL', 'BW, BMI, WC, and body fat percentage', 'Anthropometric Measures and Metabolic Profile', 'BMI', 'BW', 'Body weight (BW), body mass index (BMI), waist circumference (WC), body fat percentage, as well as clinical and laboratory determinations', 'TG and VLDL levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0330482', 'cui_str': 'Momordica charantia'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",24.0,0.169811,"Significant decreases in triglycerides (TG) (1.9 ± 0.6 mM vs. 1.7 ± 0.7 mM,  P  ≤ .05) and very low-density lipoprotein (VLDL) (0.4 ± 0.1 mM vs. 0.3 ± 0.1 mM,  P  ≤ .05) levels were found after the intervention with MC.","[{'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Cortez-Navarrete', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Science University Center, University of Guadalajara, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Méndez-Del Villar', 'Affiliation': 'Multidisciplinary Health Research Center, Biomedical Sciences Department, University Center of Tonala, University of Guadalajara, Tonala, Jalisco, Mexico.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Martínez-Abundis', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Science University Center, University of Guadalajara, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Luis D', 'Initials': 'LD', 'LastName': 'López-Murillo', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Science University Center, University of Guadalajara, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Miriam de J', 'Initials': 'MJ', 'LastName': 'Escobedo-Gutiérrez', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Science University Center, University of Guadalajara, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Lizet Y', 'Initials': 'LY', 'LastName': 'Rosales-Rivera', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Science University Center, University of Guadalajara, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Karina G', 'Initials': 'KG', 'LastName': 'Pérez-Rubio', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Science University Center, University of Guadalajara, Guadalajara, Jalisco, Mexico.'}]",Journal of medicinal food,['10.1089/jmf.2021.0164']
963,35511718,"Effects of acetazolamide on pulmonary artery pressure and prevention of high-altitude pulmonary edema after rapid active ascent to 4,559 m.","Acetazolamide prevents acute mountain sickness (AMS) by inhibition of carbonic anhydrase. Since it also reduces acute hypoxic pulmonary vasoconstriction (HPV), it may also prevent high-altitude pulmonary edema (HAPE) by lowering pulmonary artery pressure. We tested this hypothesis in a randomized, placebo-controlled, double-blind study. Thirteen healthy, nonacclimatized lowlanders with a history of HAPE ascended (<22 h) from 1,130 to 4,559 m with one overnight stay at 3,611 m. Medications were started 48 h before ascent (acetazolamide:  n  = 7, 250 mg 3 times/day; placebo:  n  = 6, 3 times/day). HAPE was diagnosed by chest radiography and pulmonary artery pressure by measurement of right ventricular to atrial pressure gradient (RVPG) by transthoracic echocardiography. AMS was evaluated with the Lake Louise Score (LLS) and AMS-C score. The incidence of HAPE was 43% versus 67% (acetazolamide vs. placebo,  P  = 0.39). Ascent to altitude increased RVPG from 20 ± 5 to 43 ± 10 mmHg ( P  < 0.001) without a group difference ( P  = 0.68). Arterial Po 2  fell to 36 ± 9 mmHg ( P  < 0.001) and was 8.5 mmHg higher with acetazolamide at high altitude ( P  = 0.025). At high altitude, the LLS and AMS-C score remained lower in those taking acetazolamide (both  P  < 0.05). Although acetazolamide reduced HAPE incidence by 35%, this effect was not statistically significant, and was considerably less than reductions of about 70%-100% with prophylactic dexamethasone, tadalafil, and nifedipine performed with the same ascent profile at the same location. We could not demonstrate a reduction in RVPG compared with placebo treatment despite reductions in AMS severity and better arterial oxygenation. Limited by small sample size, our data do not support recommending acetazolamide for the prevention of HAPE in mountaineers ascending rapidly to over 4,500 m. NEW & NOTEWORTHY  This randomized, placebo-controlled, double-blind study is the first to investigate whether acetazolamide, which reduces acute mountain sickness (AMS), inhibits short-term hypoxic pulmonary vasoconstriction, and also prevents high-altitude pulmonary edema (HAPE) in a fast-climbing ascent to 4,559 m. We found no statistically significant reduction in HAPE incidence or differences in hypoxic pulmonary artery pressures compared with placebo despite reductions in AMS and greater ventilation-induced arterial oxygenation. Our data do not support recommending acetazolamide for HAPE prevention.",2022,"At high altitude, the LLS and AMS-C score remained lower in those taking acetazolamide (both p<0.05).","['4,559 m', 'Thirteen healthy, non-acclimatized lowlanders with a history of HAPE ascended (<22h) from 1,130 to 4,559m with one overnight stay at 3,611m']","['prophylactic dexamethasone, tadalafil', 'HAPE', 'Acetazolamide', 'acetazolamide vs. placebo', 'acetazolamide', 'Medications started 48h before ascent (acetazolamide', 'placebo', 'nifedipine']","['pulmonary artery pressure and prevention of high altitude pulmonary edema', 'acute mountain sickness (AMS', 'AMS severity and better arterial oxygenation', 'HAPE incidence', 'Incidence of HAPE', 'Lake Louise Score (LLS) and AMS-C Score', 'LLS and AMS-C score']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0340100', 'cui_str': 'High altitude pulmonary edema'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0340100', 'cui_str': 'High altitude pulmonary edema'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0451613', 'cui_str': 'Medication commenced'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}]","[{'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0340100', 'cui_str': 'High altitude pulmonary edema'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",13.0,0.0615255,"At high altitude, the LLS and AMS-C score remained lower in those taking acetazolamide (both p<0.05).","[{'ForeName': 'Marc Moritz', 'Initials': 'MM', 'LastName': 'Berger', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sareban', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Lisa Maria', 'Initials': 'LM', 'LastName': 'Schiefer', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Medicine, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Kai E', 'Initials': 'KE', 'LastName': 'Swenson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Treff', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Medicine, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Schäfer', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Medicine, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Medicine, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Magdalena M', 'Initials': 'MM', 'LastName': 'Schimke', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Medicine, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paar', 'Affiliation': 'Department of Radiology, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Cogo', 'Affiliation': 'Biomedical Sport Studies Center, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Susi', 'Initials': 'S', 'LastName': 'Kriemler', 'Affiliation': 'Department of Epidemiology, Biostatistics and Public Health Institute, University of Zürich, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwery', 'Affiliation': 'Hospital of Valais, Sion, Switzerland.'}, {'ForeName': 'Philipp A', 'Initials': 'PA', 'LastName': 'Pickerodt', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Campus Charité Mitte and Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Institute for Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bärtsch', 'Affiliation': 'Department of Internal Medicine, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Swenson', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, VA Puget Sound Health Care System, University of Washington, Seattle, Washington.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00806.2021']
964,35521825,Innovative rehabilitating meal service programs for old people living at home: A randomized controlled pilot study.,"OBJECTIVE


To test the feasibility of a pilot study for a future definitive trial investigating the effect of different meal service programs for old people living at home.
DESIGN


An 8-week randomized controlled trial was performed.
SETTING


Three municipalities in the Nordic country, Denmark.
SUBJECTS


Danish participants (≥65y) with reduced functionality.
INTERVENTION


Three different meal service programs 1) 24-h meals service, 2) Protein-rich meal service, and 3) Rehabilitation meal service, were developed and compared to standard care.
MAIN MEASURES


The main outcome was study feasibility. Dietary intake, anthropometry, physical function, quality of life, readmissions and adverse events were also evaluated. Comparisons between participants receiving a meal service program and standard care were done by one-way ANOVA, chi-square test and Fishers exact test.
RESULTS


A total of 592 subjects were assessed for eligibility and 13% (76/592) were recruited. Final analysis included 75% (57/76) of participants. The outcome measures seemed acceptable and feasible though eligibility, inclusion, and completion of the intervention were lower than expected. The 24-h meal service program managed to significantly increase the intake of protein (p = 0.049) and energy (p = 0.038) compared to the control group where reductions were seen. No other significant differences were found.
CONCLUSIONS


The pilot study was feasible and several benefits for completers were seen. However, in a future definitive trial, inclusion criteria should be wider, more effort should be put on the time, training and focus of the personal in close contact to the older subjects and the intervention should be less comprehensive and more flexible.",2022,The 24-h meal service program managed to significantly increase the intake of protein (p = 0.049) and energy (p = 0.038) compared to the control group where reductions were seen.,"['A total of 592 subjects were assessed for eligibility and 13% (76/592) were recruited', 'Danish participants (≥65y) with reduced functionality', 'Three municipalities in the Nordic country, Denmark', 'old people living at home']","['Innovative rehabilitating meal service programs', 'meal service programs']","['acceptable and feasible though eligibility, inclusion, and completion of the intervention', 'intake of protein', 'Dietary intake, anthropometry, physical function, quality of life, readmissions and adverse events']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0036273', 'cui_str': 'Nordic Countries'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",592.0,0.0430529,The 24-h meal service program managed to significantly increase the intake of protein (p = 0.049) and energy (p = 0.038) compared to the control group where reductions were seen.,"[{'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Due', 'Affiliation': 'Nutrition and Health Education, 386475University College Copenhagen.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Beck', 'Affiliation': 'Research Unit for Nutrition and Dietetics, 53176Herlev and Gentofte Hospital.'}, {'ForeName': 'Camilla Banke', 'Initials': 'CB', 'LastName': 'Birk', 'Affiliation': 'Children, Health and Welfare, 362910Municipality of Albertslund.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Justesen', 'Affiliation': 'Nutrition and Health Education, 386475University College Copenhagen.'}, {'ForeName': 'Maj', 'Initials': 'M', 'LastName': 'Majgaard', 'Affiliation': 'Staff for Health and Care, 114283Municipality of Silkeborg.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Lei', 'Affiliation': 'The Danish House of Food.'}, {'ForeName': 'Sara Koldkær', 'Initials': 'SK', 'LastName': 'Langsted S', 'Affiliation': 'Children, Health and Welfare, 362910Municipality of Albertslund.'}, {'ForeName': 'Tilde Skjærlund', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Center for Health, Culture and Leisure, Municipality of Vallensbaek.'}]",Clinical rehabilitation,['10.1177/02692155221088777']
965,35523922,A retrospective comparative study of local anesthesia only and local anesthesia with sedation for percutaneous endoscopic lumbar discectomy.,"It is still an unsolved problem to achieve both immediate intraoperative feedback and satisfactory surgical experience in percutaneous endoscopic lumbar discectomy under local anesthesia for lumbar disk herniation (LDH) patients. Herein, we compared the analgesic and sedative effects of local anesthesia alone and local anesthesia with conscious sedation in LDH patients during percutaneous endoscopic lumbar discectomy. Ninety-two LDH patients were enrolled and divided into the following groups: control group (Con Group), dexmedetomidine group (Dex Group), oxycodone group (Oxy Group), and dexmedetomidine + oxycodone group (Dex + Oxy Group). Various signs, including mean arterial pressure (MAP), heart rate (HR), pulse oximeter oxygen saturation (SpO 2 ) and Ramsay score, were compared before anesthesia (T1), working cannula establishment (T2), nucleus pulposus removal (T3), and immediately postoperation (T4). Clinical outcomes, including VAS score, operation time, hospitalization period, Macnab criteria, and SF-36 score, were also evaluated. The Dex + Oxy Group showed the most stable MAP and HR at T2 and T3 in all groups. The clinical outcomes, such as VAS, hospitalization period, Macnab criteria, and SF-36 score, have no significant differences among groups (p > 0.05). Local anesthesia combined with conscious sedation is a safe and effective method to improve the surgical experience and achieve satisfying clinical outcomes for LDH patients during percutaneous endoscopic lumbar discectomy.",2022,"Clinical outcomes, including VAS score, operation time, hospitalization period, Macnab criteria, and SF-36 score, were also evaluated.","['percutaneous endoscopic lumbar discectomy under local anesthesia for lumbar disk herniation (LDH) patients', 'Ninety-two LDH patients', 'LDH patients during percutaneous endoscopic lumbar discectomy', 'percutaneous endoscopic lumbar discectomy']","['local anesthesia alone and local anesthesia with conscious sedation', 'Local anesthesia combined with conscious sedation', 'local anesthesia only and local anesthesia with sedation', 'control group (Con Group), dexmedetomidine group (Dex Group), oxycodone group (Oxy Group), and dexmedetomidine\u2009+\u2009oxycodone group (Dex\u2009+\u2009Oxy Group']","['VAS, hospitalization period, Macnab criteria, and SF-36 score', 'mean arterial pressure (MAP), heart rate (HR), pulse oximeter oxygen saturation (SpO 2 ) and Ramsay score, were compared before anesthesia (T1), working cannula establishment (T2), nucleus pulposus removal (T3), and immediately postoperation (T4', 'VAS score, operation time, hospitalization period, Macnab criteria, and SF-36 score']","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C1185714', 'cui_str': 'Nucleus Pulposus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",92.0,0.0165651,"Clinical outcomes, including VAS score, operation time, hospitalization period, Macnab criteria, and SF-36 score, were also evaluated.","[{'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Spinal Surgery, Zhengzhou Orthopaedic Hospital, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Yu-Lin', 'Initials': 'YL', 'LastName': 'Pan', 'Affiliation': 'Department of Spinal Surgery, Zhengzhou Orthopaedic Hospital, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Chun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Department of Spinal Surgery, Zhengzhou Orthopaedic Hospital, Zhengzhou, Henan Province, China.'}, {'ForeName': 'De-Xin', 'Initials': 'DX', 'LastName': 'Guo', 'Affiliation': 'Department of Spinal Surgery, Zhengzhou Orthopaedic Hospital, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedics, The Second Hospital of Jilin University, Changchun, Jilin Province, China. xzhao@jlu.edu.cn.'}]",Scientific reports,['10.1038/s41598-022-11393-4']
966,35525262,A randomized multicenter trial to evaluate early invasive strategy for patients with acute ST-segment elevation myocardial infarction presenting 24-48 hours from symptom onset: Protocol of the RESCUE-MI study.,"BACKGROUND


For ST-segment elevation myocardial infarction (STEMI) patients presenting 24 to 48 hours from symptom onset, whether early invasive strategy should be performed still remains controversial.
METHODS


This is a prospective, open-label, multicenter, investigator initiated, randomized controlled trial (NCT04962178) to evaluate the efficacy of early invasive strategy for STEMI patients within 24 to 48 hours of symptom onset. A total of 366 patients will be included from 10 hospitals in mainland China. They will be randomly (1:1) divided into 2 groups: the early invasive strategy group (primary percutaneous coronary intervention, PPCI) and conservative strategy group (optimal medical therapy with primary PCI not performed). All patients will be followed for 1 month. The primary end point is myocardial infarction size on cardiac magnetic resonance (CMR). The secondary end points are as follows: (1) major adverse cardiovascular events (MACE), which is defined as a composite of cardiac death, recurrent myocardial infarction, ischemic driven target vessel revascularization and stroke; (2) other CMR end points, including microvascular obstruction, intramyocardial hemorrhage, myocardial area at risk, left ventricular ejection fraction, left ventricular end diastolic volume and left ventricular end systolic volume.
DISCUSSION


This study is designed to evaluate the efficacy of early invasive strategy for STEMI patients within 24 to 48 hours of symptom onset and will add more evidence for clinical practice.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04962178. Registered on July 14, 2021.",2022,"They will be randomly (1:1) divided into 2 groups: the early invasive strategy group (primary percutaneous coronary intervention, PPCI) and conservative strategy group (optimal medical therapy with primary PCI not performed).All","['366 patients will be included from 10 hospitals in mainland China', 'Patients with Acute ST-segment Elevation Myocardial Infarction Presenting 24-48 Hours from Symptom Onset', 'STEMI patients within 24-48h of symptom onset']","['early invasive strategy group (primary percutaneous coronary intervention, PPCI) and conservative strategy group (optimal medical therapy with primary PCI not performed).All']","['1, major adverse cardiovascular events (MACE), which is defined as a composite of cardiac death, recurrent myocardial infarction, ischemic driven target vessel revascularization and stroke; 2, other CMR endpoints, including microvascular obstruction, intramyocardial hemorrhage, myocardial area at risk, left ventricular ejection fraction, left ventricular end diastolic volume and left ventricular end systolic volume', 'myocardial infarction size on cardiac magnetic resonance (CMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",366.0,0.0850057,"They will be randomly (1:1) divided into 2 groups: the early invasive strategy group (primary percutaneous coronary intervention, PPCI) and conservative strategy group (optimal medical therapy with primary PCI not performed).All","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai, China.'}, {'ForeName': 'Yuanji', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai, China.'}, {'ForeName': 'Ruochen', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai, China.'}, {'ForeName': 'Shihai', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Medical Imaging, Shanghai, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Medical Imaging, Shanghai, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai, China. Electronic address: jbge@zs-hospital.sh.cn.'}]",American heart journal,['10.1016/j.ahj.2022.05.002']
967,35526570,Comparison of anticoagulation with left atrial appendage closure after atrial fibrillation ablation: Rationale and design of the OPTION randomized trial.,"BACKGROUND


For patients with symptomatic atrial fibrillation (AF), physicians typically offer AF ablation for symptom relief; however, patients often anticipate/expect a life free from anticoagulation. This belief puts patients at increased risk of stroke due to the potential for asymptomatic AF postablation if anticoagulation is ceased contrary to clinical guidelines. Although the WATCHMAN device has been FDA-approved to decrease the risk of thromboembolism from the left atrial appendage (LAA) in patients with an appropriate rationale to avoid oral anticoagulation, it has not been well-studied following AF ablation. Additionally, there are limited data comparing the WATCHMAN device to direct oral anticoagulants. The OPTION study will investigate whether LAA closure with the WATCHMAN FLX device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for nonvalvular AF.
TRIAL DESIGN


OPTION is a multinational, multicenter, prospective randomized clinical trial. Patients with a CHA 2 DS 2 -VASc of ≥2 in men or ≥3 in women and who underwent a AF catheter ablation procedure between 90 and 180 days prior to randomization (sequential) or are planning to have catheter ablation within 10 days of randomization (concomitant) will be randomized in a 1:1 allocation of WATCHMAN FLX vs control. Control patients will start or continue market-approved oral anticoagulation for the duration of the trial. A total of 1600 patients were randomized from 130 global investigational sites. Follow-up for both device and control patients will occur at 3, 12, 24, and 36 months. The primary effectiveness noninferiority endpoint is stroke (ischemic or hemorrhagic), all-cause death, or systemic embolism at 36 months. The primary safety superiority endpoint is nonprocedural bleeding through 36 months (International Society on Thrombosis and Haemostasis [ISTH] major bleeding or clinically relevant nonmajor bleeding). The secondary noninferiority endpoint is ISTH major bleeding through 36 months (including procedural bleeding).
CONCLUSIONS


This trial will assess the safety and efficacy of WATCHMAN FLX in a postablation contemporary clinical AF patient population at risk of stroke.",2022,"This trial will assess the safety and efficacy of WATCHMAN FLX in a post-ablation contemporary clinical AF patient population at risk of stroke.
","['1600 patients were randomized from 130 global investigational sites', 'Patients with a CHA 2 DS 2 -VASc of ≥2 in men or ≥3 in women and who underwent a AF catheter ablation procedure between 90 and 180 days prior to randomization (sequential) or are', 'patients with symptomatic atrial fibrillation (AF']","['planning to have catheter ablation', 'percutaneous catheter ablation', 'FLX', 'Anticoagulation with Left Atrial Appendage Closure after AF Ablation']","['safety and efficacy', 'non-procedural bleeding through 36 months (International Society on Thrombosis and Haemostasis [ISTH] major bleeding or clinically relevant non-major bleeding', 'stroke (ischemic or hemorrhagic), all-cause death, or systemic embolism', 'ISTH major bleeding through 36 months (including procedural bleeding']","[{'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0162560', 'cui_str': 'Percutaneous Catheter Ablation'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3203457', 'cui_str': 'Procedural haemorrhage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",1600.0,0.0906131,"This trial will assess the safety and efficacy of WATCHMAN FLX in a post-ablation contemporary clinical AF patient population at risk of stroke.
","[{'ForeName': 'Oussama M', 'Initials': 'OM', 'LastName': 'Wazni', 'Affiliation': 'Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, OH. Electronic address: waznio@ccf.org.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Boersma', 'Affiliation': 'Cardiology Department, St Antonius Hospital, Nieuwegein, the Netherlands/Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Moussa', 'Initials': 'M', 'LastName': 'Mansour', 'Affiliation': 'Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Tondo', 'Affiliation': 'Department of Clinical Electrophysiology & Cardiac Pacing, Heart Rhythm Center at Monzino Cardiac Center, IRCCS, Department of Biochemical, Surgical and Dentist Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'The Brisbane AF Clinic, Greenslopes Private Hospital, Greenslopes, Brisbane, Australia.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Doshi', 'Affiliation': 'Cardiac Arrhythmia Group, HonorHealth, Scottsdale, AZ.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Jaber', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Fuad Jubran Endowed Chair in Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hynes', 'Affiliation': 'Boston Scientific Corporation, Marlborough, MA.'}, {'ForeName': 'Dominic J', 'Initials': 'DJ', 'LastName': 'Allocco', 'Affiliation': 'Boston Scientific Corporation, Marlborough, MA.'}, {'ForeName': 'Vivek Y', 'Initials': 'VY', 'LastName': 'Reddy', 'Affiliation': 'Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2022.05.003']
968,35526942,The role of cross-link augmentation on fusion rate and patient satisfaction among patients with traumatic thoracolumbar spinal fracture: A randomized clinical trial.,"INTRODUCTION AND OBJECTIVES


Most of the studies evaluating the effect of cross links on spinal stability are performed in vitro on porcine or human spine segments and there is limited data regarding clinical benefits of cross link augmentation in traumatic injuries. In this study we aimed to evaluate the effects of cross-links insertion between rods on the fusion rates and post-surgical patients' satisfaction among patients with traumatic thoracolumbar fractures who underwent posterior spinal fixation with pedicle screws.
MATERIALS AND METHODS


This study was conducted as a randomized clinical trial on 60 patients suffering from traumatic thoracolumbar vertebrae fractures. Patients were randomized into three groups: A (without any cross-link), B (One cross-link insertion) and C (two cross-links insertion). Six months after surgery outcomes were evaluated: fusion rates (plain X-ray and CT scan), Back pain (Visual Analog Scale) and patient satisfaction (fair, good, excellent).
RESULTS


In group A 13 (65%) patients had structured bone fusion, but in 7 (35%) patients bone fusion was not observed. In both groups B and C, 19 patients (95%) had bone fusion, but only in 1 patient (5%) fusion failed (p=0.009). In group A, fair satisfaction has the highest rate (8 patients (40%)) compared to the other groups. The highest reported severity of back pain was observed in group A while the lowest reported intensity of back pain was related to group B (p=0.001).
CONCLUSIONS


Adding cross link to posterior spinal fixations of patients with traumatic thoracolumbar fractures can be associated with better final fusion results and patients' satisfaction. However it is necessary to design studies with greater sample sizes to confirm this theory.
TRIAL REGISTRATION NUMBER


IRCT20120527009878N3.",2022,"In group A, fair satisfaction has the highest rate (8 patients (40%)) compared to the other groups.","['60 patients suffering from traumatic thoracolumbar vertebrae fractures', 'patients with traumatic thoracolumbar fractures', 'patients with traumatic thoracolumbar spinal fracture', 'patients with traumatic thoracolumbar fractures who underwent']","['posterior spinal fixation with pedicle screws', 'cross-link augmentation']","['intensity of back pain', 'severity of back pain', 'bone fusion', 'structured bone fusion', 'fusion rate and patient satisfaction', 'fusion rates (plain X-ray and CT scan), Back pain (Visual Analog Scale) and patient satisfaction (fair, good, excellent']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C1267077', 'cui_str': 'Thoracolumbar vertebrae'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0185364', 'cui_str': 'Osteoplasty'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}]",60.0,0.0469815,"In group A, fair satisfaction has the highest rate (8 patients (40%)) compared to the other groups.","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arad', 'Initials': 'A', 'LastName': 'Iranmehr', 'Affiliation': 'Department of Neurosurgery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ghaffar', 'Initials': 'G', 'LastName': 'Shokouhi', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Khadivi', 'Affiliation': 'Department of Neurosurgery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moslem', 'Initials': 'M', 'LastName': 'Shakeri', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Namvar', 'Affiliation': 'Department of Neurosurgery, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mohamad.namvar@gmail.com.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Rafiei', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Bagher', 'Initials': 'B', 'LastName': 'Matloubi', 'Affiliation': 'Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Neurocirugia (English Edition),['10.1016/j.neucie.2021.01.003']
969,35534494,A randomised clinical trial to assess the adjuvant potential of methotrexate to corticosteroids in mucosal or limited mucocutaneous pemphigus vulgaris.,"Glucocorticoids are the mainstay of treatment for pemphigus vulgaris (PV). However, the requirement of high doses for long durations often leads to serious adverse events. Methotrexate as an adjuvant has shown potential in retrospective studies but randomized trials are lacking. The objective of the study was to assess the adjuvant potential of methotrexate in mucosal/limited mucocutaneous PV. In this randomised prospective study, 44 patients with mucosal/limited mucocutaneous PV were randomised (1:1) to receive either prednisolone 1 mg/kg/day (later fixed at a maximum dose of 60 mg/day) alone or with methotrexate 0.3 mg/kg/week for 9-months study period. Prednisolone dose was tapered once there was an 80% reduction in Pemphigus Disease Activity Index. Outcome measures were total cumulative dose of prednisolone, the proportion of patients achieving disease control, time taken for disease control and remission on minimal treatment, and adverse effects. No significant difference in the total cumulative dose of prednisolone among the groups was observed (p = 0.68). Disease control was achieved in 95.5% and 86.4% of patients in the prednisolone alone group, and prednisolone and methotrexate group respectively (p = 0.61). No statistically significant difference was observed among the groups with respect to the proportion of patients achieving remission, time taken for disease control and remission, and the number of adverse events. Our study showed no additional benefit of methotrexate to prednisolone in the treatment of mucosal/limited mucocutaneous PV.Trial registration: CTRI/2018/07/015002; Registered on 23/07/2018]; Trial Registered Retrospectively. http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=24964&EncHid=&modid=&compid=%27,%2724964det%27 .",2022,No significant difference in the total cumulative dose of prednisolone among the groups was observed (p = 0.68).,"['pemphigus vulgaris (PV', '44 patients with mucosal/limited mucocutaneous PV']","['prednisolone 1\xa0mg/kg/day (later fixed at a maximum dose of 60 mg/day)\xa0alone or with methotrexate', 'prednisolone', 'methotrexate to prednisolone', 'Methotrexate', 'Prednisolone', 'Glucocorticoids', 'methotrexate to corticosteroids', 'prednisolone and methotrexate', 'methotrexate']","['Pemphigus Disease Activity Index', 'Disease control', 'total cumulative dose of prednisolone', 'proportion of patients achieving remission, time taken for disease control and remission, and the number of adverse events', 'total cumulative dose of prednisolone, the proportion of patients achieving disease control, time taken for disease control and remission on minimal treatment, and adverse effects']","[{'cui': 'C0030809', 'cui_str': 'Pemphigus vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C1129612', 'cui_str': 'prednisolone 1 MG'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0030807', 'cui_str': 'Pemphigus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",44.0,0.224769,No significant difference in the total cumulative dose of prednisolone among the groups was observed (p = 0.68).,"[{'ForeName': 'Khimit', 'Initials': 'K', 'LastName': 'Jain', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Thakur', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Handa', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Thakur', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shilpa', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Sachdeva', 'Affiliation': 'Department of Endocrinology (Immunology Division), Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India.'}, {'ForeName': 'Dipankar', 'Initials': 'D', 'LastName': 'De', 'Affiliation': 'Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India. dr_dipankar_de@yahoo.in.'}]",Scientific reports,['10.1038/s41598-022-11387-2']
970,35537503,"COMPARE LAAO: Rationale and design of the randomized controlled trial ""COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy"".","BACKGROUND


Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking.
STUDY OBJECTIVES


To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications.
STUDY DESIGN


This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands.
SUMMARY


The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
NCT TRIAL NUMBER


NCT04676880.",2022,"The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
","['patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking', 'AF patients with a high thromboembolic risk and a contraindication for OAC use', 'Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC', 'AF patients who are ineligible to use OAC', 'patients with atrial fibrillation (AF', 'atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy']","['percutaneous LAAO and will receive post procedural dual antiplatelet therapy (DAPT', 'oral anticoagulation (OAC', 'antithrombotic therapy or (D)APT', 'Left atrial appendage occlusion (LAAO', 'Left Atrial Appendage Occlusion', 'LAAO']","['efficacy and safety', '30-day rate of peri-procedural complications', '1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA) and systemic embolism (SE', 'stroke risk of LAAO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C3275093', 'cui_str': 'Left atrial appendage occlusion'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",609.0,0.0919684,"The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Huijboom', 'Affiliation': 'Cardiology Department, St. Antonius Hospital, Nieuwegein, The Netherlands; Amsterdam University Medical Center, location AMC, Cardiology Department, Amsterdam, The Netherlands. Electronic address: m.huijboom@antoniusziekenhuis.nl.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Maarse', 'Affiliation': 'Cardiology Department, St. Antonius Hospital, Nieuwegein, The Netherlands; Amsterdam University Medical Center, location AMC, Cardiology Department, Amsterdam, The Netherlands.'}, {'ForeName': 'Errol', 'Initials': 'E', 'LastName': 'Aarnink', 'Affiliation': 'Cardiology Department, St. Antonius Hospital, Nieuwegein, The Netherlands; Amsterdam University Medical Center, location AMC, Cardiology Department, Amsterdam, The Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'van Dijk', 'Affiliation': 'Cardiology Department, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Swaans', 'Affiliation': 'Cardiology Department, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'van der Heijden', 'Affiliation': 'Cardiology Department, Haga Hospital, Den Haag, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'IJsselmuiden', 'Affiliation': 'Cardiology Department, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Folkeringa', 'Affiliation': 'Medical Center Leeuwarden, Cardiology Department, Leeuwarden, The Netherlands.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Blaauw', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Cardiology Department, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Stevenhagen', 'Affiliation': 'Medical Spectrum Twente, Department of Cardiology, Enschede, The Netherlands.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Vlachojannis', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van der Voort', 'Affiliation': 'Cardiology Department, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Westra', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Marisevi', 'Initials': 'M', 'LastName': 'Chaldoupi', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Muchtiar', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'Cardiology Department, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'de Groot', 'Affiliation': 'Amsterdam University Medical Center, location AMC, Cardiology Department, Amsterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van der Kley', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'van Mieghem', 'Affiliation': 'Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Ewoud', 'Initials': 'E', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Dijkgraaf', 'Affiliation': 'Location AMC, Department of Epidemiology and Data Science, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tijssen', 'Affiliation': 'Clinical Epidemiology & Biostatistics, Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Boersma', 'Affiliation': 'Cardiology Department, St. Antonius Hospital, Nieuwegein, The Netherlands; Amsterdam University Medical Center, location AMC, Cardiology Department, Amsterdam, The Netherlands.'}]",American heart journal,['10.1016/j.ahj.2022.05.001']
971,35504550,Efficacy of antimicrobial photodynamic therapy versus antiviral therapy in the treatment of herpetic gingivostomatitis among children: Aa randomized controlled clinical trial.,"AIM


The aim of the present study was to evaluate the effect of antimicrobial photodynamic therapy (aPDT) as an adjunctive treatment to topical antiviral therapy for the treatment of children having herpetic gingivostomatitis.
MATERIALS AND METHODS


45 individuals (age group 12-18 years) with herpetic gingivostomatitis (HG) were divided into three groups on the basis of provision of treatment. (a) Group A: topical anti-viral therapy (TAT) (n = 14, mean age = 17.0 years) (b) Group B: antimicrobial photodynamic therapy (aPDT) (n = 15, mean age =17.7 years) and (c) Group C: topical anti-viral therapy + adjunctive aPDT (n = 16, mean age = 18.0 years) respectively. Pain scores [visual analogue scale (VAS) and McGill Pain Questionnaire (MPQ)] were assessed and HSV-1 was quantified. ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) was used to compute the pro-inflammatory cytokine including interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). The analysis of the mean values and inter group comparisons were evaluated with the Mann-Whitney test. The Friedman test was used to establish the comparison of the changes observed in HSV quantification, pain scores, and pro-inflammatory cytokines. ANOVA tests were employed for the quantification of differences observed at follow-ups. The assessments for the clinical trial were done at baseline, immediate after post-op, two, and four weeks, and three and six months respectively.
RESULTS


According to the analysis of the data obtained after the clinical assessment, the three groups reported a decrease in the pain scores, HSV-1 quantification and levels of the pro-inflammatory cytokines. However, Group C (TAT + aPDT) reported improvement in the observed parameters which was statistically significant in comparison to Group A (TAT) and Group B (aPDT) respectively.
CONCLUSION


Antimicrobial photodynamic therapy (aPDT) in conjunction with topical antiviral therapy (TAT) helped in reducing the pain scores and pro-inflammatory cytokine levels in herpetic gingivostomatitis among children.",2022,"According to the analysis of the data obtained after the clinical assessment, the three groups reported a decrease in the pain scores, HSV-1 quantification and levels of the pro-inflammatory cytokines.","['herpetic gingivostomatitis among children', 'children having herpetic gingivostomatitis', ' : 45 individuals (age group 12-18 years) with herpetic gingivostomatitis (HG', 'n=15, mean age =17.7 years) and (c) Group C', 'n=16, mean age\u202f=\u202f18.0 years) respectively']","['topical antiviral therapy', 'antimicrobial photodynamic therapy (aPDT', 'Antimicrobial photodynamic therapy (aPDT', 'antiviral therapy', 'topical antiviral therapy (TAT', 'topical anti-viral therapy (TAT', 'topical anti-viral therapy\u202f+\u202fadjunctive aPDT', 'antimicrobial photodynamic therapy']","['pain scores, HSV-1 quantification and levels of the pro-inflammatory cytokines', 'Pain scores [visual analogue scale (VAS) and McGill Pain Questionnaire (MPQ', 'pain scores and pro-inflammatory cytokine levels', 'HSV quantification, pain scores, and pro-inflammatory cytokines']","[{'cui': 'C0376379', 'cui_str': 'Herpetic gingivostomatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C1874329', 'cui_str': 'Antivirals'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1563738', 'cui_str': 'Virotherapy, Oncolytic'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0206679', 'cui_str': 'Human herpesvirus 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0019348', 'cui_str': 'Herpes simplex'}]",,0.078733,"According to the analysis of the data obtained after the clinical assessment, the three groups reported a decrease in the pain scores, HSV-1 quantification and levels of the pro-inflammatory cytokines.","[{'ForeName': 'Sajith', 'Initials': 'S', 'LastName': 'Vellappally', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh 11433, Saudi Arabia. Electronic address: svellappally@ksu.edu.sa.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Biochemistry, College of Science, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Samer M', 'Initials': 'SM', 'LastName': 'Alaqeel', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Rasha N', 'Initials': 'RN', 'LastName': 'Alotaibi', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Almansour', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Alageel', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hashem', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, P.O. Box 10219, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Fouad', 'Affiliation': 'Biomedical Engineering Department, Faculty of Engineering, Helwan University, Cairo, Egypt.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Saadaldin', 'Affiliation': 'Schulich School of Medicine & Dentistry Western University London, Ontario, Canada.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Sukumaran', 'Affiliation': 'Department of Dentistry-Oral Health Institute, Hamad Medical Corporation, Doha, Qatar; College of Dental Medicine, Qatar University, Doha, Qatar. Electronic address: anil.sukumaran.anil@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2022.102895']
972,35513882,Effect of behavioral activation on time and frequency domain heart rate variability in older adults with subthreshold depression: a cluster randomized controlled trial in Thailand.,"BACKGROUND


Increased prevalence of depression highlights the need for effective interventions. Behavioral activation (BA), which can easily be adapted for non-clinical populations, has been the recommended treatment for depression. It is based on a model of psychopathology explaining that losses or chronically low levels of positive reinforcement yield behavioral and emotional changes in depression and that encouraging individuals to increase their engagement in reinforcing activities can improve their mood and enhance their valuable life experiences. Heart rate variability (HRV) provides indices of autonomic function related to depression, but only a few studies have investigated the effect of BA on HRV, particularly among older adults with subthreshold depression. Accordingly, we aimed to investigate the effect of BA on HRV in older adults with subthreshold depression.
METHODS


We conducted a 9-month cluster randomized controlled trial in two Health Promoting Hospitals (HPHs). Eighty-two participants were randomized into either intervention (BA with usual care) or control (usual care only) groups, with 41 participants per group. Daily step count was collected weekly during the 12-week BA intervention period, while HRV parameters, including the Standard Deviation of the Normal-to-Normal interval (SDNN), High Frequency (lnHF), Low Frequency (LF), and Low Frequency/High Frequency ratio (LF/HF), were examined at 0, 3, 6 and 9 months. Generalized Estimating Equations (GEEs) were used in the data analysis.
RESULTS


Over nine months, the intervention and control groups differed significantly in the unadjusted mean change of HRV, SDNN [7.59 ms (95% CI: 1.67, 13.50)], lnHF [0.44 ms 2  (95% CI: 0.04, 0.85)], and LF [0.53 ms 2  (95% CI: 0.09, 0.98)], whereas the groups did not differ significantly in LF/HF ratio [0.01 ms 2  (95% CI: -0.04, 0.06)].
CONCLUSION


Our results suggest that BA may have a therapeutic effect on depression symptoms of older adults with subthreshold depression via improved HRV.
TRIAL REGISTRATION


TCTR20211019003 , thaiclinicaltrials.org, retrospectively registered on 19 October 2021.",2022,"Eighty-two participants were randomized into either intervention (BA with usual care) or control (usual care only) groups, with 41 participants per group.","['two Health Promoting Hospitals (HPHs', 'Eighty-two participants', 'older adults with subthreshold depression via improved HRV', 'older adults with subthreshold depression']","['BA', 'behavioral activation', 'intervention (BA with usual care) or control (usual care only']","['LF/HF ratio', 'Standard Deviation of the Normal-to-Normal interval (SDNN), High Frequency (lnHF), Low Frequency (LF), and Low Frequency/High Frequency ratio (LF/HF', 'unadjusted mean change of HRV, SDNN', 'Behavioral activation (BA', 'Daily step count']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",82.0,0.110321,"Eighty-two participants were randomized into either intervention (BA with usual care) or control (usual care only) groups, with 41 participants per group.","[{'ForeName': 'Wanvisa Saisanan Na', 'Initials': 'WSN', 'LastName': 'Ayudhaya', 'Affiliation': 'Department of Community Public Health, School of Public Health, Walailak University, Nakhon Si Thammarat, Thailand.'}, {'ForeName': 'Nuttorn', 'Initials': 'N', 'LastName': 'Pityaratstian', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Wichai', 'Initials': 'W', 'LastName': 'Eungpinichpong', 'Affiliation': 'Research Center in Back, Neck, and Other Joint Pain and Human Performance, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thanapoom', 'Initials': 'T', 'LastName': 'Rattananupong', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Parinya', 'Initials': 'P', 'LastName': 'Kitidumrongsuk', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Sriprapa', 'Initials': 'S', 'LastName': 'Loonlawong', 'Affiliation': 'Regional Health Promotion Center 9 Nakhon Ratchasima, Department of Health, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Wiroj', 'Initials': 'W', 'LastName': 'Jiamjarasrangsi', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. wjiamja@gmail.com.'}]",BMC psychiatry,['10.1186/s12888-022-03962-8']
973,35522281,Effect of a Novel Online Group-Coaching Program to Reduce Burnout in Female Resident Physicians: A Randomized Clinical Trial.,"Importance


Female resident physicians are disproportionately affected by burnout, which can have serious consequences for their well-being and career trajectory. Growing evidence supports the use of professional coaching to reduce burnout in resident physicians, yet individual coaching is resource intensive and infeasible for many training programs.
Objective


To assess whether a structured professional group-coaching program for female resident physicians would lead to decreased burnout.
Design, Setting, and Participants


This pilot randomized clinical trial was conducted from January 1 to June 30, 2021, among 101 female resident physicians in graduate medical education at the University of Colorado who voluntarily enrolled in the trial after a recruitment period. Surveys were administered to participants before and after the intervention.
Intervention


With the use of a computer-generated 1:1 algorithm, 50 participants were randomly assigned to the intervention group and 51 participants were randomly assigned to the control group. The intervention group was offered a 6-month, web-based group-coaching program, Better Together Physician Coaching, developed and facilitated by trained life coaches and physicians. The control group received residency training as usual, with no coaching during the study. The control group was offered the 6-month coaching program after study completion.
Main Outcomes and Measures


The primary outcome of burnout was measured using the Maslach Burnout Inventory, defined by 3 Likert-type 7-point subscales: emotional exhaustion, depersonalization, and professional accomplishment. Higher scores on the emotional exhaustion and depersonalization subscales and lower scores on the professional accomplishment subscale indicate higher burnout. Secondary outcomes of impostor syndrome, self-compassion, and moral injury were assessed using the Young Impostor Syndrome Scale, Neff's Self-Compassion Scale-Short Form, and the Moral Injury Symptom Scale-Healthcare Professionals, respectively. An intention-to-treat analysis was performed.
Results


Among the 101 female residents in the study, the mean (SD) age was 29.4 (2.3) years, 96 (95.0%) identified as heterosexual, and 81 (80.2%) identified as White. There were 19 residents (18.8%) from surgical subspecialties, with a range of training levels represented. After 6 months of professional coaching, emotional exhaustion decreased in the intervention group by a mean (SE) of 3.26 (1.25) points compared with a mean (SE) increase of 1.07 (1.12) points in the control group by the end of the study (P = .01). The intervention group experienced a significant reduction in presence of impostor syndrome compared with controls (mean [SE], -1.16 [0.31] vs 0.11 [0.27] points; P = .003). Self-compassion scores increased in the intervention group by a mean (SE) of 5.55 (0.89) points compared with a mean (SE) reduction of 1.32 (0.80) points in the control group (P < .001). No statistically significant differences in depersonalization, professional accomplishment, or moral injury scores were observed. Owing to the differential follow-up response rates in the treatment groups (88.2% in the control group [45 of 51]; 68.0% in the intervention group [34 of 50]), a sensitivity analysis was performed to account for the missing outcomes, with similar findings.
Conclusions and Relevance


In this randomized clinical trial, professional coaching reduced emotional exhaustion and impostor syndrome scores and increased self-compassion scores among female resident physicians.
Trial Registration


ClinicalTrials.gov Identifier: NCT05280964.",2022,"In this randomized clinical trial, professional coaching reduced emotional exhaustion and impostor syndrome scores and increased self-compassion scores among female resident physicians.
","['female resident physicians', '50 participants were randomly assigned to the intervention group and 51 participants', '101 female residents in the study, the mean (SD) age was 29.4 (2.3) years, 96 (95.0%) identified as heterosexual, and 81 (80.2%) identified as White', 'Female Resident Physicians', 'January 1 to June 30, 2021, among 101 female resident physicians in graduate medical education at the University of Colorado who voluntarily enrolled in the trial after a recruitment period']","['computer-generated 1:1 algorithm', 'professional coaching', 'residency training as usual, with no coaching', 'structured professional group-coaching program', 'web-based group-coaching program, Better Together Physician Coaching', 'Novel Online Group-Coaching Program']","['emotional exhaustion and depersonalization subscales', 'professional accomplishment subscale', 'emotional exhaustion and impostor syndrome scores', 'emotional exhaustion', 'depersonalization, professional accomplishment, or moral injury scores', 'Maslach Burnout Inventory, defined by 3 Likert-type 7-point subscales: emotional exhaustion, depersonalization, and professional accomplishment', 'self-compassion scores', ""impostor syndrome, self-compassion, and moral injury were assessed using the Young Impostor Syndrome Scale, Neff's Self-Compassion Scale-Short Form, and the Moral Injury Symptom Scale-Healthcare Professionals, respectively"", 'presence of impostor syndrome', 'Self-compassion scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0013633', 'cui_str': 'Education, Graduate Medical'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0016684', 'cui_str': 'Fraud'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4505439', 'cui_str': 'Moral Injury'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",50.0,0.0413636,"In this randomized clinical trial, professional coaching reduced emotional exhaustion and impostor syndrome scores and increased self-compassion scores among female resident physicians.
","[{'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Fainstad', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Mann', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Krithika', 'Initials': 'K', 'LastName': 'Suresh', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora.'}, {'ForeName': 'Pari', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Graduate School of Social Work, University of Denver, Denver, Colorado.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Dieujuste', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado, School of Medicine, Aurora.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Thurmon', 'Affiliation': 'Division of Urology, Department of Surgery, Denver Health, Denver, Colorado.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Jones', 'Affiliation': 'Division of Hospital Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.10752']
974,35524760,Breast Nurse Intervention to Improve Adherence to Endocrine Therapy Among Breast Cancer Patients in South Ethiopia.,"INTRODUCTION


Many women in rural Ethiopia do not receive adjuvant therapy following breast cancer surgery despite the majority being diagnosed with estrogen-receptor-positive breast cancer and tamoxifen being available in the country. We aimed to compare a breast nurse intervention to improve adherence to tamoxifen therapy for breast cancer patients.
METHODS AND MATERIALS


The 8 hospitals were randomized to intervention and control sites. Between February 2018 and December 2019, patients with breast cancer were recruited after their initial surgery. The primary outcome of the study was adherence to tamoxifen therapy by evaluating 12-month medication-refill data with medication possession ratio (MPR) and using a simplified medication adherence scale (SMAQ) in a subjective assessment.
RESULTS


A total of 162 patients were recruited (87 intervention and 75 control). Trained nurses delivered education and provided literacy material, gave additional empathetic counselling, phone call reminders, and monitoring of medication refill at the intervention hospitals. Adherence according to MPR at 12 months was high in both the intervention (90%) and control sites (79.3%) (P = .302). The SMAQ revealed that adherence at intervention sites was 70% compared with 44.8% in the control sites (P = .036) at 12 months. Persistence to therapy was found to be 91.2% in the intervention and 77.8% in the control sites during the one-year period (P = .010).
CONCLUSION


Breast nurses can improve cost-effective endocrine therapy adherence at peripheral hospitals in low-resource settings. We recommend such task sharing to overcome the shortage of oncologists and distances to central cancer centers.",2022,Adherence according to MPR at 12 months was high in both the intervention (90%) and control sites (79.3%) (P = .302).,"['Between February 2018 and December 2019, patients with breast cancer were recruited after their initial surgery', 'Breast Cancer Patients in South Ethiopia', 'breast cancer patients', 'A total of 162 patients were recruited (87 intervention and 75 control']","['Endocrine Therapy', 'tamoxifen therapy', 'Breast Nurse Intervention', 'tamoxifen', 'breast nurse intervention']","['Adherence according to MPR', 'cost-effective endocrine therapy adherence', 'adherence to tamoxifen therapy by evaluating 12-month medication-refill data with medication possession ratio (MPR) and using a simplified medication adherence scale (SMAQ) in a subjective assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C4510392', 'cui_str': 'Tamoxifen therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C4510392', 'cui_str': 'Tamoxifen therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",162.0,0.0649345,Adherence according to MPR at 12 months was high in both the intervention (90%) and control sites (79.3%) (P = .302).,"[{'ForeName': 'Sefonias', 'Initials': 'S', 'LastName': 'Getachew', 'Affiliation': 'Department of Preventive Medicine, School of Public Health, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Adamu', 'Initials': 'A', 'LastName': 'Addissie', 'Affiliation': 'Department of Preventive Medicine, School of Public Health, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Edom', 'Initials': 'E', 'LastName': 'Seife', 'Affiliation': 'Radiotherapy Center, Tikur Anbessa Hospital, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Tariku', 'Initials': 'T', 'LastName': 'Wakuma', 'Affiliation': 'Department of Surgery, Aira General Hospital, Ethiopia.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Unverzagt', 'Affiliation': 'Institute of General Practice and Family Medicine, Center of Health Sciences, Martin-Luther-University \xa0Halle (Saale), Germany.'}, {'ForeName': 'Ahmedin', 'Initials': 'A', 'LastName': 'Jemal', 'Affiliation': 'American Cancer Society, Atlanta, Georgia, USA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'City of Hope National Medical Center, Duarte, California \xa0USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wienke', 'Affiliation': 'Institute of Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University (Saale), Halle, Germany.'}, {'ForeName': 'Eva J', 'Initials': 'EJ', 'LastName': 'Kantelhardt', 'Affiliation': 'Institute of Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University (Saale), Halle, Germany.'}]",The oncologist,['10.1093/oncolo/oyac081']
975,35527126,Effect of physical activity in a weight loss program on circulating total ANGPTL8 concentrations in northern Americans with obesity: A prospective randomized controlled trial.,"BACKGROUND AND AIMS


The primary goals of this study were to clarify 1) the effect of weight loss by lifestyle intervention on circulating total angiopoietin-like protein 8 (ANGPTL8), and 2) the role of physical activity on serum total ANGPTL8 in northern Americans with obesity but without diabetes.
METHODS AND RESULTS


A total of 130 subjects with body mass index (BMI) ≧ 35 kg/m 2  but without diabetes were recruited, and 121 subjects completed a weight loss program for data analysis. Abdominal adipose tissue was determined by non-contrast computed tomography (CT). Serum total ANGPTL8 was higher in the group with obesity than in the lean control group. Serum total ANGPTL8 was positively correlated with waist circumference (WC), BMI, fasting insulin, HOMA-IR, HOMA-B, QUICKI, hs-CRP, IL-6, and leptin. Serum total ANGPTL8 did not significantly differ between the two intervention groups at baseline, and it was significantly lower after weight loss, with comparable changes with diet only and diet plus physical activity.
CONCLUSION


Among northern Americans with obesity but without diabetes, a lifestyle modification resulted in significant reduction of circulating total ANGPTL8 concentrations in a 6-month weight-loss period. Although addition of physical activity resulted in greater total and liver fat loss, it did not promote further significant decline of serum total ANGPTL8 beyond diet alone.",2022,"Serum total ANGPTL8 did not significantly differ between the two intervention groups at baseline, and it was significantly lower after weight loss, with comparable changes with diet only and diet plus physical activity.
","['130 subjects with body mass index (BMI)\xa0≧', 'northern Americans with obesity', 'northern Americans with obesity but without diabetes', '35\xa0kg/m 2  but without diabetes were recruited, and 121 subjects completed a weight loss program for data analysis']","['weight loss program', 'physical activity']","['Serum total ANGPTL8', 'Abdominal adipose tissue', 'circulating total angiopoietin-like protein 8 (ANGPTL8), and 2) the role of physical activity on serum total ANGPTL8 in northern Americans with obesity but without diabetes', 'waist circumference (WC), BMI, fasting insulin, HOMA-IR, HOMA-B, QUICKI, hs-CRP, IL-6, and leptin', 'total and liver fat loss', 'weight loss']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C4505321', 'cui_str': 'Angiopoietin-like Protein'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",130.0,0.0113074,"Serum total ANGPTL8 did not significantly differ between the two intervention groups at baseline, and it was significantly lower after weight loss, with comparable changes with diet only and diet plus physical activity.
","[{'ForeName': 'Chia-Po', 'Initials': 'CP', 'LastName': 'Fu', 'Affiliation': 'Graduate Institute of Biomedical Electronics and Bioinformatics, College of Electrical Engineering and Computer Science, National Taiwan University, Taipei, Taiwan; Division of Endocrinology and Metabolism, Department of Medicine, Taichung Veterans General Hospital, Taichung, Taiwan; Department of Medicine, Chung Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Oczypok', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, PA 15261, USA.'}, {'ForeName': 'Hira', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, PA 15261, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'DeLany', 'Affiliation': 'Translational Research Institute Adventhealth, Florida, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Reeves', 'Affiliation': 'Customer Delivery, Data Science Platform, Broad Institute of MIT and Harvard, Cambridge, MA 02412, USA.'}, {'ForeName': 'Ruey-Feng', 'Initials': 'RF', 'LastName': 'Chang', 'Affiliation': 'Graduate Institute of Biomedical Electronics and Bioinformatics, College of Electrical Engineering and Computer Science, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Kershaw', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, PA 15261, USA. Electronic address: kershawee@upmc.edu.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2022.04.006']
976,35529283,Comparison of  clinical effectiveness of conventional and self-etch sealant: a split mouth randomized controlled trial.,"Background:  Self-etching has been shown to be beneficial compared to the other resin sealants especially in pediatric practice. The present  in-vivo  study was designed to clinically evaluate the sealing ability and retention of the self-etching sealant compared to the conventional resin sealant. The aim was to evaluate and compare the retention and marginal integrity of the self-etch and acid etch sealant materials at three, six and twelve-month follow up.  Methods:  The study was designed as a double blinded, split mouth randomized controlled trial, . In total, 35 children (70 teeth) between 7 and 10 years of age formed part of the study. Group 1 received acid-etch sealant and Group 2 received self-etch sealants. The study participants and the investigator who performed the statistical analysis were blinded to the treatment allocation. All the samples were evaluated at 3, 6, and 12 months. The inter-group and intragroup comparison were carried out using the Chi-Square test and Friedman test with level of significance set at 5% and the P value less than 0.05.  Results:  Complete retention of sealants was observed in 34.5% of conventional acid etch (group 1) and 22.9% of self-etch samples (group 2) whereas complete loss of sealants were seen in 11.4% of group 1 and 20% of the group 2 samples and intergroup comparison of retention failure was non-significant (p=0.135). In total, 85.7% of the group 1 and 82.9% of the group 2 samples exhibited good marginal integrity with no clinical changes in the enamel around the margins but this was not statistically significant (p=0.5).  Conclusions:  Sealants with fewer procedural steps and those which provide adequate retention would be ideal for use in children. Thus, self-etch sealants have been found to be effective and efficient as a sealant in the present  in-vivo  study.  Clinical Trials Registry, India registration:  CTRI/2019/03/018343 (29/03/2019).",2022,Complete retention of sealants was observed in 34.5% of conventional acid etch (group 1) and 22.9% of self-etch samples (group 2) whereas complete loss of sealants were seen in 11.4% of group 1 and 20% of the group 2 samples and intergroup comparison of retention failure was non-significant (p=0.135).,"['35 children (70 teeth) between 7 and 10 years of age formed part of the study', 'permanent molars']","['conventional acid-etch sealant', 'conventional resin sealant', 'acid-etch sealant and Group 2 received self-etch sealants', 'self-etch sealant']","['good marginal integrity', 'retention failure', 'Complete retention of sealants', 'complete loss of sealants']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}]",35.0,0.204224,Complete retention of sealants was observed in 34.5% of conventional acid etch (group 1) and 22.9% of self-etch samples (group 2) whereas complete loss of sealants were seen in 11.4% of group 1 and 20% of the group 2 samples and intergroup comparison of retention failure was non-significant (p=0.135).,"[{'ForeName': 'Deveshi', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Pediatric & Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, 575001, India.'}, {'ForeName': 'Arathi', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'Pediatric & Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, 575001, India.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Shenoy', 'Affiliation': 'Public Health Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, 575001, India.'}, {'ForeName': 'Baranya Srikrishna', 'Initials': 'BS', 'LastName': 'Suprabha', 'Affiliation': 'Pediatric & Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, 575001, India.'}]",F1000Research,['10.12688/f1000research.109584.3']
977,35533220,Text Messages to Improve Medication Adherence and Secondary Prevention After Acute Coronary Syndrome: The TEXTMEDS Randomized Clinical Trial.,"BACKGROUND


TEXTMEDS (Text Messages to Improve Medication Adherence and Secondary Prevention After Acute Coronary Syndrome) examined the effects of text message-delivered cardiac education and support on medication adherence after an acute coronary syndrome.
METHODS


TEXTMEDS was a single-blind, multicenter, randomized controlled trial of patients after acute coronary syndrome. The control group received usual care (secondary prevention as determined by the treating clinician); the intervention group also received multiple motivational and supportive weekly text messages on medications and healthy lifestyle with the opportunity for 2-way communication (text or telephone). The primary end point of self-reported medication adherence was the percentage of patients who were adherent, defined as >80% adherence to each of up to 5 indicated cardioprotective medications, at both 6 and 12 months.
RESULTS


A total of 1424 patients (mean age, 58 years [SD, 11]; 79% male) were randomized from 18 Australian public teaching hospitals. There was no significant difference in the primary end point of self-reported medication adherence between the intervention and control groups (relative risk, 0.93 [95% CI, 0.84-1.03];  P =0.15). There was no difference between intervention and control groups at 12 months in adherence to individual medications (aspirin, 96% vs 96%; β-blocker, 84% vs 84%; angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, 77% vs 80%; statin, 95% vs 95%; second antiplatelet, 84% vs 84% [all  P >0.05]), systolic blood pressure (130 vs 129 mm Hg;  P =0.26), low-density lipoprotein cholesterol (2.0 vs 1.9 mmol/L;  P =0.34), smoking ( P =0.59), or exercising regularly (71% vs 68%;  P =0.52). There were small differences in lifestyle risk factors in favor of intervention on body mass index <25 kg/m 2  (21% vs 18%;  P =0.01), eating ≥5 servings per day of vegetables (9% vs 5%;  P =0.03), and eating ≥2 servings per day of fruit (44% vs 39%;  P =0.01).
CONCLUSIONS


A text message-based program had no effect on medical adherence but small effects on lifestyle risk factors.
REGISTRATION


URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364448; Unique identifier: ANZCTR ACTRN12613000793718.",2022,"There was no significant difference in the primary end point of self-reported medication adherence between the intervention and control groups (relative risk, 0.93","['1424 patients (mean age, 58 years [SD, 11]; 79% male) were randomized from 18 Australian public teaching hospitals', 'After Acute Coronary Syndrome', 'patients after acute coronary syndrome']","['usual care (secondary prevention as determined by the treating clinician); the intervention group also received multiple motivational and supportive weekly text messages on medications and healthy lifestyle with the opportunity for 2-way communication (text or telephone', 'text message-delivered cardiac education and support']","['eating ≥5 servings per day of vegetables', 'lifestyle risk factors', 'self-reported medication adherence', 'systolic blood pressure', 'medical adherence', 'low-density lipoprotein cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0679699', 'cui_str': 'Secondary prevention'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",1424.0,0.0498544,"There was no significant difference in the primary end point of self-reported medication adherence between the intervention and control groups (relative risk, 0.93","[{'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Institute (C.K.C., H.K., A.T., A.V.H., A.R.), University of Sydney, Australia.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Klimis', 'Affiliation': 'Westmead Applied Research Institute (C.K.C., H.K., A.T., A.V.H., A.R.), University of Sydney, Australia.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Thiagalingam', 'Affiliation': 'Westmead Applied Research Institute (C.K.C., H.K., A.T., A.V.H., A.R.), University of Sydney, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'Faculty of Medicine and Health (J.R., R.B., M.A.F., M.M.), University of Sydney, Australia.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Hillis', 'Affiliation': 'University of Western Australia, Perth (G.S.H., P.T.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brieger', 'Affiliation': 'ANZAC Research Institute (D.B.), University of Sydney, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Atherton', 'Affiliation': ""Department of Cardiology, Royal Brisbane and Women's Hospital, Brisbane, Australia (J.A.).""}, {'ForeName': 'Ravinay', 'Initials': 'R', 'LastName': 'Bhindi', 'Affiliation': 'Faculty of Medicine and Health (J.R., R.B., M.A.F., M.M.), University of Sydney, Australia.'}, {'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Chew', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia (D.P.C., N.K.).'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Collins', 'Affiliation': 'Hunter Medical Research Institute, Newcastle, Australia (N.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Andrew Fitzpatrick', 'Affiliation': 'Faculty of Medicine and Health (J.R., R.B., M.A.F., M.M.), University of Sydney, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Juergens', 'Affiliation': 'Faculty of Medicine, The University of New South Wales, Sydney, Australia (C.J.).'}, {'ForeName': 'Nadarajah', 'Initials': 'N', 'LastName': 'Kangaharan', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia (D.P.C., N.K.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'Allied Health Department, Fiona Stanley Hospital, Perth, Australia (A.M.).'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'McGrady', 'Affiliation': 'Faculty of Medicine and Health (J.R., R.B., M.A.F., M.M.), University of Sydney, Australia.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Poulter', 'Affiliation': 'Department of Cardiology, Sunshine Coast University Hospital, Brisbane, Australia (R.P.).'}, {'ForeName': 'Pratap', 'Initials': 'P', 'LastName': 'Shetty', 'Affiliation': 'Department of Cardiology, Wollongong and Shellharbour Hospitals, Wollongong, Australia (P.S.).'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Waites', 'Affiliation': 'Coffs Cardiology, Coffs Harbour, Australia (J.W.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamilton Craig', 'Affiliation': 'The University of Queensland, Brisbane, Australia (J.A., C.H.C.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thompson', 'Affiliation': 'University of Western Australia, Perth (G.S.H., P.T.).'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Stepien', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia (C.K.C., H.K., A.R., G.S.H., S.S., A.R.).'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Von Huben', 'Affiliation': 'Westmead Applied Research Institute (C.K.C., H.K., A.T., A.V.H., A.R.), University of Sydney, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'Westmead Applied Research Institute (C.K.C., H.K., A.T., A.V.H., A.R.), University of Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.121.056161']
978,35544437,"The Efficacy of a Brief, Altruism-Eliciting Video Intervention in Enhancing COVID-19 Vaccination Intentions Among a Population-Based Sample of Younger Adults: Randomized Controlled Trial.","BACKGROUND


High COVID-19 vaccine uptake is crucial to containing the pandemic and reducing hospitalizations and deaths. Younger adults (aged 20-39 years) have demonstrated lower levels of vaccine uptake compared to older adults, while being more likely to transmit the virus due to a higher number of social contacts. Consequently, this age group has been identified by public health authorities as a key target for vaccine uptake. Previous research has demonstrated that altruistic messaging and motivation is associated with vaccine acceptance.
OBJECTIVE


This study had 2 objectives: (1) to evaluate the within-group efficacy of an altruism-eliciting short, animated video intervention in increasing COVID-19 vaccination intentions amongst unvaccinated Canadian younger adults and (2) to examine the video's efficacy compared to a text-based intervention focused exclusively on non-vaccine-related COVID-19 preventive health measures.
METHODS


Using a web-based survey in a pre-post randomized control trial (RCT) design, we recruited Canadians aged 20-39 years who were not yet vaccinated against COVID-19 and randomized them in a 1:1 ratio to receive either the video intervention or an active text control. The video intervention was developed by our team in collaboration with a digital media company. The measurement of COVID-19 vaccination intentions before and after completing their assigned intervention was informed by the multistage Precaution Adoption Process Model (PAPM). The McNemar chi-square test was performed to evaluate within-group changes of vaccine intentions. Exact tests of symmetry using pairwise McNemar tests were applied to evaluate changes in multistaged intentions. Between-group vaccine intentions were assessed using the Pearson chi-square test postintervention.
RESULTS


Analyses were performed on 1373 participants (n=686, 50%, in the video arm, n=687, 50%, in the text arm). Within-group results for the video intervention arm showed that there was a significant change in the intention to receive the vaccine (χ 2 1 =20.55, P<.001). The between-group difference in postintervention intentions (χ 2 3 =1.70, P=.64) was not significant. When administered the video intervention, we found that participants who had not thought about or were undecided about receiving a COVID-19 vaccine were more amenable to change than participants who had already decided not to vaccinate.
CONCLUSIONS


Although the video intervention was limited in its effect on those who had firmly decided not to vaccinate, our study demonstrates that prosocial and altruistic messages could increase COVID-19 vaccine uptake, especially when targeted to younger adults who are undecided or unengaged regarding vaccination. This might indicate that altruistic messaging provides a ""push"" for those who are tentative toward, or removed from, the decision to receive the vaccine. The results of our study could also be applied to more current COVID-19 vaccination recommendations (eg, booster shots) and for other vaccine-preventable diseases.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04960228; https://clinicaltrials.gov/ct2/show/NCT04960228.",2022,"The between-group difference in post-intervention intentions (χ^2(3) = 1.70, P = .64) was not significant.","['Younger adults (aged 20-39', 'unvaccinated Canadian younger adults', 'participants who had not thought about or were undecided about receiving a', 'Analyses were performed on N = 1373 participants (n = 686 in video arm, n = 687 in text arm', 'younger adults who are undecided or unengaged regarding vaccination', 'recruited Canadians aged 20-39 who were not yet vaccinated against COVID-19 and randomized them in a 1:1 ratio to receive either the', 'younger adults', 'enhancing COVID-19 vaccination intentions amongst a population-based sample of younger adults']","['animated video that highlights altruistic reasons for COVID-19 vaccination', 'altruism-eliciting video intervention', 'video intervention or an active text control', 'COVID-19 vaccine', 'video intervention']","['COVID-19 vaccination intentions', 'COVID-19 vaccine uptake', 'vaccine uptake']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002357', 'cui_str': 'Altruism - mental defense mechanism'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",1373.0,0.110652,"The between-group difference in post-intervention intentions (χ^2(3) = 1.70, P = .64) was not significant.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Tatar', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Griffin-Mathieu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Samara', 'Initials': 'S', 'LastName': 'Perez', 'Affiliation': 'Cedars Cancer Center, McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Haward', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Zimet', 'Affiliation': 'Division of Adolescent Medicine, Indiana University School of Medicine, Indianapolis, IN, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Tunis', 'Affiliation': 'National Advisory Committee on Immunization Secretariat, Centre for Immunization Readiness, Public Health Agency of Canada, Ottawa, ON, Canada.'}, {'ForeName': 'Ève', 'Initials': 'È', 'LastName': 'Dubé', 'Affiliation': 'Faculty of Social Sciences; Anthropology, University of Laval, Québec, QC, Canada.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Rosberger', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}]",JMIR public health and surveillance,['10.2196/37328']
979,35550423,Rapid Cycle Deliberate Practice Versus Traditional Simulation to Improve Resident Performance in Forceps Deliveries.,"This study aimed to assess the effectiveness of rapid cycle deliberate practice (RCDP) in improving obstetrics and gynaecology residents' performance and skill retention in forceps-assisted vaginal deliveries. Thirty-three residents were randomly assigned to RCDP or traditional debriefing. Performance was evaluated using an objective structured assessment of technical skills (OSATS) tool. There were no significant differences in immediate performance scores between groups (P = 0.082). At 4-6 months, both groups demonstrated improved performance scores (traditional, P = 0.001; RCDP, P = 0.001). Seventy-six percent of residents in the RCDP group indicated ""real-time"" feedback was advantageous. Three residents suggested this method was less beneficial at a senior level.",2022,"At 4-6 months, both groups demonstrated improved performance scores (traditional, P = 0.001; RCDP, P = 0.001).","['Thirty-three residents', 'forceps-assisted vaginal deliveries', 'forceps deliveries']","['rapid cycle deliberate practice (RCDP', 'RCDP', 'RCDP or traditional debriefing']","['real-time"" feedback', 'immediate performance scores', 'performance scores']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1384586', 'cui_str': 'Forceps delivery'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",33.0,0.0274613,"At 4-6 months, both groups demonstrated improved performance scores (traditional, P = 0.001; RCDP, P = 0.001).","[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Pascoal', 'Affiliation': 'Department of Obstetrics and Gynecology, McMaster University, Hamilton, ON. Electronic address: erica.pascoal@medportal.ca.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Mueller', 'Affiliation': 'Department of Obstetrics and Gynecology, McMaster University, Hamilton, ON.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Morais', 'Affiliation': 'Department of Obstetrics and Gynecology, McMaster University, Hamilton, ON.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2022.04.011']
980,35512507,Effects of an emotional support programme on older adults living in nursing homes: A quasi-experimental study.,"This study aimed to examine the feasibility and validity of an emotional support programme developed for older adults living in nursing homes, using a quasi-experimental design. Older adults in the intervention group attended a 12-week emotional support programme while those in the control group received usual care. Outcome variables, assessed at baseline and at 1-month and 3-month follow ups, included nursing home adjustment, perceived social support, and quality of life. Group-by-time interaction effects were found concerning nursing home adjustment and perceived social support. Significant improvements in the two variables were observed in the intervention group, but no significant difference was found in quality of life. The emotional support programme based on social learning theory resulted in significant improvements in nursing home adjustment and perceived social support. To respond to the demands of an ageing society, further studies are needed on this topic.",2022,"Significant improvements in the two variables were observed in the intervention group, but no significant difference was found in quality of life.","['Older adults', 'older adults living in nursing homes']","['emotional support programme', 'emotional support programme while those in the control group received usual care']","['nursing home adjustment and perceived social support', 'quality of life', 'nursing home adjustment, perceived social support, and quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}]","[{'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0251542,"Significant improvements in the two variables were observed in the intervention group, but no significant difference was found in quality of life.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cui', 'Affiliation': 'MSN, Nantong University Medical School, No19, Qixiu Road, Chong Chuan District, Nantong, Jiangsu, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Miao', 'Affiliation': 'MSN, Nantong University Medical School, No19, Qixiu Road, Chong Chuan District, Nantong, Jiangsu, China.'}, {'ForeName': 'Jianqun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'MSN, North Nantong Nursing Home, No18, Fuda Road, Chong Chuan District, Nantong, Jiangsu, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'MSN, Nantong University Medical School, No19, Qixiu Road, Chong Chuan District, Nantong, Jiangsu, China.'}, {'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'BM, Nantong University Medical School, No19, Qixiu Road, Chong Chuan District, Nantong, Jiangsu, China.'}, {'ForeName': 'Xiangyun', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': ""MSN, Nantong Third People's Hospital, No. 60 Qingnian Zhong road, Chongchuan District, Nantong, Jiangsu 226001, China. Electronic address: qxy03062020@126.com.""}, {'ForeName': 'Guiling', 'Initials': 'G', 'LastName': 'Geng', 'Affiliation': 'MSN, Nantong University Medical School, No19, Qixiu Road, Chong Chuan District, Nantong, Jiangsu, China. Electronic address: sxl1105421943@163.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.04.005']
981,35513159,Roux-en-Y gastric bypass versus best medical treatment for type 2 diabetes mellitus in adults with body mass index between 27 and 32 kg/m 2 : A 5-year randomized controlled trial.,"AIMS


To evaluate the effects of Roux-en-Y gastric bypass (RYGB) versus best medical treatment in Asians with type 2 diabetes mellitus (T2DM) and class I obesity.
METHODS


In this 5-year single-centre, open-label randomized controlled trial, participants were randomized to RYGB or medical treatment including newer classes of diabetes medications (ClinicalTrials.gov:NCT02041234). The primary endpoint was diabetes remission defined as HbA1c ≤ 6% (≤42 mmol/mol) and discontinuation of glucose-lowering medication at 12 months post-intervention and beyond. Glycaemia and weight changes were assessed. Continuous glucose monitoring was performed.
RESULTS


Of 28 subjects randomized, 26 were analyzed in the final cohort (14 medical, 12 RYGB; age:44 ± 10 years, 34.6% males, BMI:29.4 ± 1.6 kg/m 2 ). At 12 months, 50% of RYGB subjects achieved diabetes remission; 83% stopped all glucose-lowering medications. By year 5, 42% were in remission. None attained diabetes remission in the medical group. Percentage declines in fasting plasma glucose, HbA1c and BMI were significantly greater in the RYGB arm (all P < 0.05). Early improvements in glycaemic variability and time in range were similar in both treatment arms. Hypoglycaemia and surgical complications were observed in some RYGB subjects.
CONCLUSIONS


Over 5 years, RYGB outperforms best medical treatment in glycemia and weight improvements for Asians with T2DM and class I obesity.",2022,"Percentage declines in fasting plasma glucose, HbA1c and BMI were significantly greater in the RYGB arm (all P<0.05).","['type 2 diabetes mellitus in adults with body mass index between 27 and 32 kg/m 2 ', 'Asians with type 2 diabetes mellitus (T2DM) and class I obesity', '28 subjects randomized']","['Roux-en-Y gastric bypass versus best medical treatment', 'Roux-en-Y gastric bypass (RYGB']","['Hypoglycaemia and surgical complications', 'Glycaemia and weight changes', 'diabetes remission defined as HbA1c≤6% (≤42 mmol/mol) and discontinuation of glucose-lowering medication', 'fasting plasma glucose, HbA1c and BMI', 'diabetes remission', 'glycaemic variability and time in range']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}]",28.0,0.0384238,"Percentage declines in fasting plasma glucose, HbA1c and BMI were significantly greater in the RYGB arm (all P<0.05).","[{'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Department of General Surgery, Khoo Teck Puat Hospital, Singapore; Clinical Research Unit, Khoo Teck Puat Hospital, Singapore. Electronic address: cheng.anton.ks@ktph.com.sg.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Yeoh', 'Affiliation': 'Diabetes Centre, Admiralty Medical Centre, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Moh', 'Affiliation': 'Clinical Research Unit, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Low', 'Affiliation': 'Clinical Research Unit, Khoo Teck Puat Hospital, Singapore; Diabetes Centre, Admiralty Medical Centre, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Chun Hai', 'Initials': 'CH', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Khoo Teck Puat Hospital, Singapore; Integrated Centre for Obesity and Diabetes, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lam', 'Affiliation': 'Integrated Centre for Obesity and Diabetes, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Chee Fang', 'Initials': 'CF', 'LastName': 'Sum', 'Affiliation': 'Clinical Research Unit, Khoo Teck Puat Hospital, Singapore; Diabetes Centre, Admiralty Medical Centre, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Tavintharan', 'Initials': 'T', 'LastName': 'Subramaniam', 'Affiliation': 'Clinical Research Unit, Khoo Teck Puat Hospital, Singapore; Diabetes Centre, Admiralty Medical Centre, Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Su Chi', 'Initials': 'SC', 'LastName': 'Lim', 'Affiliation': 'Clinical Research Unit, Khoo Teck Puat Hospital, Singapore; Diabetes Centre, Admiralty Medical Centre, Khoo Teck Puat Hospital, Singapore; Saw Swee Hock School of Public Health, National University Hospital, Singapore; Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2022.109900']
982,35513977,Childhood adversity is associated with heightened inflammation after sleep loss.,"OBJECTIVES


To investigate whether childhood adversity exacerbates the relationship between sleep restriction and inflammation.
METHODS


Participants (N = 46) were randomly assigned to an experimental sleep restriction group (n = 25) or a night of typical sleep (n = 21). Participants provided a dried blood spot sample the morning before and after the experimental night.
RESULTS


A significant interaction emerged between childhood adversity and group assignment on C-reactive protein (CRP) after the experimental night (Beta = -0.02, SE = 0.01, P = .03, 95% CI: -0.05, -0.002). Sleep restriction resulted in an increase in CRP at high levels of childhood adversity (+1 SD; Effect = -0.57, SE = 0.15, P< .001; 95% CI: -0.87, -0.26) but not low levels of childhood adversity (Effect = -0.08, SE = 0.10, P = .40; 95% CI: -0.29, 0.12).
CONCLUSION


Childhood adversity may amplify the effect of sleep loss on markers of inflammation.",2022,"A significant interaction emerged between childhood adversity and group assignment on C-reactive protein (CRP) after the experimental night (Beta = -0.02, SE = 0.01, P = .03, 95% CI: -0.05, -0.002).",['Participants (N\xa0=\xa046'],['experimental sleep restriction group (n\xa0=\xa025) or a night of typical sleep'],"['CRP at high levels of childhood adversity', 'C-reactive protein (CRP']",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]",46.0,0.0730349,"A significant interaction emerged between childhood adversity and group assignment on C-reactive protein (CRP) after the experimental night (Beta = -0.02, SE = 0.01, P = .03, 95% CI: -0.05, -0.002).","[{'ForeName': 'Neha A', 'Initials': 'NA', 'LastName': 'John-Henderson', 'Affiliation': 'Montana State University, Department of Psychology, Bozeman, Montana, USA. Electronic address: Neha.johnhenderson@montana.edu.'}, {'ForeName': 'Taylor D', 'Initials': 'TD', 'LastName': 'Kampf', 'Affiliation': 'Montana State University, Department of Psychology, Bozeman, Montana, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Alvarado', 'Affiliation': 'Montana State University, Department of Psychology, Bozeman, Montana, USA.'}, {'ForeName': 'Cory J', 'Initials': 'CJ', 'LastName': 'Counts', 'Affiliation': 'Montana State University, Department of Psychology, Bozeman, Montana, USA.'}, {'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Larsen', 'Affiliation': 'Montana State University, Department of Psychology, Bozeman, Montana, USA.'}, {'ForeName': 'Cara A', 'Initials': 'CA', 'LastName': 'Palmer', 'Affiliation': 'Montana State University, Department of Psychology, Bozeman, Montana, USA.'}]",Sleep health,['10.1016/j.sleh.2022.03.006']
983,35524188,Study protocol for 'the effects of multimodal training of cognitive and/or physical functions on cognition and physical fitness of older adults: a cluster randomized controlled trial'.,"BACKGROUND


The elderly population worldwide is increasing exponentially which will be associated with more people suffering from cognition and fitness declines. The well-established benefits of exercise training for the elderly's cognitive and physical functioning have been observed. However, the amalgamated effect of combining cognitive and physical exercises on the older adults' cognitive functions, physical fitness, or psycho-related health remains unclear. Thus, this study protocol was planned to conduct different combinations of cognitive and/or physical training interventions to community-dwelling older adults and expected to see the multifaceted effects of the varied combination of training on their health.
METHODS


This study is a cluster randomized controlled trial (CRCT). A total of 285 older adults (age ≥ 60) from twenty elderly centres as clusters will be randomly selected and assigned to intervention groups (IGs, n = 16) or control groups (CGs, n = 4). Each IG will be randomly assigned to one of the four combinations of three training modes that include cognitive (A), physical (B), and combined cognitive and physical training (CCPT, i.e. C), namely Mixed ABC, A + B, C + A, B + C. The intervention will last for 4 months in which the training is conducted for 16 sessions, 2 sessions per week, and 60 min per session. Four repeated assessments (pre-test, two post-training tests after 2 months and 4 months, and a follow-up test) will be conducted. The CG will only receive the four repeated assessments but no intervention. The outcome measures include cognitive tests (tests of execution, memory, and psych-social status), physical fitness, and dynamic balance tests.
DISCUSSION


This study will provide substantial evidence that the integrated format of cognitive and physical exercises training will have higher cognition and fitness impact than the single training modes, and all these mixed modalities will have greater positive outcomes than the control condition. If the effectiveness is proven, the intervention can be further explored and extended to the nation so that many more elderly would be benefited.
TRIAL REGISTRATION


The trial has been registered in the ClinicalTrials.gov in U.S. NIH (ID: NCT04727450 , date: January 27, 2021).",2022,"If the effectiveness is proven, the intervention can be further explored and extended to the nation so that many more elderly would be benefited.
","['community-dwelling older adults', '285 older adults (age\u2009≥\u200960) from twenty elderly centres as clusters', 'older adults']","['multimodal training of cognitive and/or physical functions', 'cognitive and/or physical training interventions', 'cognitive and physical exercises', 'three training modes that include cognitive (A), physical (B), and combined cognitive and physical training (CCPT, i.e. C), namely Mixed ABC, A\u2009+\u2009B, C\u2009+\u2009A, B\u2009+\u2009C', 'exercise training', 'physical exercises training']","['cognition and physical fitness', 'cognitive tests (tests of execution, memory, and psych-social status), physical fitness, and dynamic balance tests']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",285.0,0.0205733,"If the effectiveness is proven, the intervention can be further explored and extended to the nation so that many more elderly would be benefited.
","[{'ForeName': 'Bik-Chu', 'Initials': 'BC', 'LastName': 'Chow', 'Affiliation': 'Dr. Stephen Hui Research Centre for Physical Recreation and Wellness, Faculty of Social Sciences, Hong Kong Baptist University, Kowloon Tong, Hong Kong, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Dr. Stephen Hui Research Centre for Physical Recreation and Wellness, Faculty of Social Sciences, Hong Kong Baptist University, Kowloon Tong, Hong Kong, China. jojojiao@hkbu.edu.hk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Man', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong, China.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Lippke', 'Affiliation': 'Department of Psychology & Methods, Jacobs University, Bremen, Germany.'}]",BMC geriatrics,['10.1186/s12877-022-03031-5']
984,35525238,Pilot randomized trial of cognitive-behavioral treatment plus contingency management for quitting smoking and weight gain prevention among smokers with overweight or obesity.,"BACKGROUND


Post-cessation weight gain is a risk factor for relapse among quitters. The primary study aim was to evaluate, among smokers with overweight or obesity, the feasibility and acceptability of a cognitive-behavioral treatment (CBT) plus contingency management (CM) for quitting smoking and weight control. The secondary aim was to examine preliminary tobacco abstinence and weight change outcomes.
METHODS


In an 8-week pilot randomized clinical trial, 41 participants (M age  = 52.73, SD = 10.91, 56.1% females) with overweight or obesity (M BMI  = 31.86, SD = 4.7) received a CBT for both quitting smoking and weight gain prevention (n = 24) or the same treatment plus CM (n = 17), consisting of providing incentives contingent upon smoking abstinence biochemically verified.
RESULTS


Recruitment success rate was 80.39% (41/51), completion rate was 90.24% (37/41), and mean number of sessions attended (out of 15 possible) was 13.20 (SD = 3.1). Mean satisfaction rating for the treatment (1-10 likert-type scale with 10 being most satisfactory) was 9.73 (SD =.61). Preliminary efficacy data indicated that the CM group achieved higher abstinence rates compared with the CBT condition (100% vs. 58.33%, p = .007). Abstinent participants increased 1.25 kg (SD = 1.79) their baseline body weight at the end of treatment (p = .001).
CONCLUSIONS


Providing weight gain prevention strategies and CM within a smoking cessation treatment seems feasible and acceptable. Preliminary data indicated that including CM facilitates tobacco abstinence rates, nevertheless no advantage for CM was found for weight control.",2022,"Preliminary efficacy data indicated that the CM group achieved higher abstinence rates compared with the CBT condition (100% vs. 58.33%, p = .007).","['smokers with overweight or obesity', '41 participants (M age  = 52.73, SD = 10.91, 56.1% females) with overweight or obesity (M BMI  = 31.86, SD = 4.7) received a']","['cognitive-behavioral treatment plus contingency management', 'cognitive-behavioral treatment (CBT) plus contingency management (CM', 'CBT for both quitting smoking and weight gain prevention (n\xa0=\xa024) or the same treatment plus CM (n\xa0=\xa017), consisting of providing incentives contingent upon smoking abstinence biochemically verified']","['quitting smoking and weight gain prevention', 'baseline body weight', 'completion rate', 'abstinence rates', 'tobacco abstinence rates', 'Mean satisfaction rating']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",41.0,0.154078,"Preliminary efficacy data indicated that the CM group achieved higher abstinence rates compared with the CBT condition (100% vs. 58.33%, p = .007).","[{'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'García-Fernández', 'Affiliation': 'Department of Psychology, Addictive Behaviours Research Group, University of Oviedo, Plaza Feijoo S-N, Oviedo 33003, Spain. Electronic address: garciafgloria@uniovi.es.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Krotter', 'Affiliation': 'Department of Psychology, Addictive Behaviours Research Group, University of Oviedo, Plaza Feijoo S-N, Oviedo 33003, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García-Pérez', 'Affiliation': 'Department of Psychology, Addictive Behaviours Research Group, University of Oviedo, Plaza Feijoo S-N, Oviedo 33003, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Aonso-Diego', 'Affiliation': 'Department of Psychology, Addictive Behaviours Research Group, University of Oviedo, Plaza Feijoo S-N, Oviedo 33003, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Secades-Villa', 'Affiliation': 'Department of Psychology, Addictive Behaviours Research Group, University of Oviedo, Plaza Feijoo S-N, Oviedo 33003, Spain.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109477']
985,35525132,Standard care versus individualized blood pressure targets among critically ill patients with shock: A multicenter feasibility and preliminary efficacy study.,"PURPOSE


Emerging evidence suggests that minimizing mean perfusion pressure (MPP) deficit during vasopressor therapy for shock can potentially reduce adverse kidney-related outcomes in ICU. We assessed feasibility and preliminary efficacy of individualizing MPP targets based on patients' own pre-illness basal-MPP among vasopressor-treated patients with shock.
MATERIAL AND METHODS


In this prospective before-and-after trial, 31 patients during the 'before'/observational phase and 31 patients during the 'after'/intervention phase were enrolled at two tertiary-level Australian ICUs. Feasibility endpoint was time-weighted average MPP-deficit during vasopressor therapy. Preliminary efficacy outcomes were new significant AKI, major adverse kidney events within 14 days (MAKE-14), and 90-day mortality.
RESULTS


Patients in the after group had lower MPP-deficit (median 18%, [interquartile range [IQR]: 11-23] vs. 4%, [IQR: 2-9], p < 0.001) and lower incidence of new significant AKI (8/31 [26%] vs. 1/31 [3%], p = 0.01) than the before group. The between-group differences in MAKE-14 (9/31 [29%] vs. 4/31 [13%], p = 0.12) and 90-day mortality (6/31 [19%] vs. 2/31 [6%], p = 0.13) were not statistically significant.
CONCLUSIONS


An individualized blood pressure target strategy during vasopressor therapy in ICU was feasible and appeared to be efficacious in this preliminary study. Testing this strategy in a larger randomized controlled trial is warranted.
STUDY REGISTRATION


ACTRN12617001459314.",2022,An individualized blood pressure target strategy during vasopressor therapy in ICU was feasible and appeared to be efficacious in this preliminary study.,"[""patients' own pre-illness basal-MPP among vasopressor-treated patients with shock"", ""31 patients during the 'before'/observational phase and 31 patients during the 'after'/intervention phase were enrolled at two tertiary-level Australian ICUs"", 'critically ill patients with shock']","['Standard care versus individualized blood pressure targets', 'individualizing MPP']","['new significant AKI, major adverse kidney events within 14 days (MAKE-14), and 90-day mortality', 'mean perfusion pressure (MPP) deficit', 'lower MPP-deficit', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",31.0,0.0847309,An individualized blood pressure target strategy during vasopressor therapy in ICU was feasible and appeared to be efficacious in this preliminary study.,"[{'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, Newcastle, Australia; School of Medicine and Public Health, University of Newcastle, Australia. Electronic address: rakshit.panwar@health.nsw.gov.au.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Van Haren', 'Affiliation': 'Intensive Care Unit, St George Hospital, Sydney, Australia; University of New South Wales Medicine and Health, Sydney, Australia; Australian National University, College of Health and Medicine, Canberra, Australia.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Cazzola', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Nourse', 'Affiliation': 'Intensive Care Unit, Canberra Hospital, Canberra, Australia.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Brinkerhoff', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Quail', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Australia.'}]",Journal of critical care,['10.1016/j.jcrc.2022.154052']
986,35525050,"Quantifying virtual reality pain modulation in healthy volunteers: A randomized, crossover study.","STUDY OBJECTIVE


Virtual reality (VR) is an emerging tool to reduce pain and anxiety during procedures. Although VR's clinical benefits are reported, biometric data quantifying VR's effect on pain tolerance is lacking. We used time-lapse, subjective, and biometric data to evaluate VR's effect on modulating pain.
DESIGN


Randomized, controlled crossover within-subject clinical trial.
SETTING


This study was conducted in the Chariot Lab at Lucile Packard Children's Hospital and outdoors at Stanford University School of Medicine.
PATIENTS


156 healthy volunteers were included.
INTERVENTIONS


Participants underwent pain-inducing ice immersions while connected to biometric sensors. Participants were randomized to immerse their dominant or non-dominant hand with VR or control (no VR) for one immersion, and then crossed-over to the other hand for the second immersion. We instructed participants to submerge their hand until they reached their pain tolerance or until four minutes elapsed.
MEASUREMENTS


Outcomes included ice immersion duration, perceived pain scores, and skin conductance response density (SCRD), a marker of sympathetic arousal. We used survival analysis and mixed effects models to compare measurements with and without VR.
MAIN RESULTS


153 participants were included in the analysis. Participants with VR were 64% less likely to remove their hands from the ice bath throughout the immersion's duration compared to control (P < 0.001). Participants with VR reported significantly lower pain scores after controlling for dominant hand treatment assignment, VR vs. no VR treatment order, and gender (P < 0.001). SCRD increased as time progressed for both VR and control groups (P = 0.047 combined), with no significant mean group differences.
CONCLUSIONS


Participants with VR were more likely to survive the 4-min ice bath challenge longer and with lower levels of pain perception, supporting VR's effectiveness as a distraction tool during painful procedures. We observed no differences in sympathetic response when comparing VR to no VR.",2022,"Participants with VR reported significantly lower pain scores after controlling for dominant hand treatment assignment, VR vs. no VR treatment order, and gender (P ","['healthy volunteers', ""Chariot Lab at Lucile Packard Children's Hospital and outdoors at Stanford University School of Medicine"", '153 participants were included in the analysis', '156 healthy volunteers were included']",['immerse their dominant or non-dominant hand with VR or control (no VR'],"['pain tolerance', 'sympathetic response', 'pain perception', 'SCRD', 'pain scores', 'pain and anxiety', 'ice immersion duration, perceived pain scores, and skin conductance response density (SCRD), a marker of sympathetic arousal']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0449722', 'cui_str': 'Dominant hand'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",156.0,0.0948052,"Participants with VR reported significantly lower pain scores after controlling for dominant hand treatment assignment, VR vs. no VR treatment order, and gender (P ","[{'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Neiman', 'Affiliation': ""Stanford Chariot Program, Lucile Packard Children's Hospital Stanford, Palo Alto, CA, USA; DeBusk College of Osteopathic Medicine, Lincoln Memorial University, Knoxville, TN, USA.""}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Falkson', 'Affiliation': 'Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Division of Pediatric Anesthesiology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Ellen Y', 'Initials': 'EY', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Division of Pediatric Anesthesiology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Sydney F', 'Initials': 'SF', 'LastName': 'Hemphill', 'Affiliation': 'Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Khoury', 'Affiliation': ""Stanford Chariot Program, Lucile Packard Children's Hospital Stanford, Palo Alto, CA, USA.""}, {'ForeName': 'Madison N', 'Initials': 'MN', 'LastName': 'Kist', 'Affiliation': ""Stanford Chariot Program, Lucile Packard Children's Hospital Stanford, Palo Alto, CA, USA.""}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Jackson', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Division of Pediatric Anesthesiology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Caruso', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Division of Pediatric Anesthesiology, Stanford School of Medicine, Stanford, CA, USA. Electronic address: tjcaruso@stanford.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2022.110876']
987,35526590,Comparison of the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density: A Randomized Clinical Trial.,"PURPOSE


To compare the differences in retinal vessel density (VD) between topical administration of latanoprostene bunod (LBN) ophthalmic solution 0.024% and timolol maleate 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) and normal subjects.
DESIGN


Randomized, single center, crossover clinical trial.
METHODS


Eligible subjects were examined during 6 study visits over 12 weeks. All subjects were randomized in a 1:1 ratio to LBN dosed once daily or timolol dosed twice daily in both eyes (OU) for a duration of 4 weeks each, separated by a 2-week washout period. A comprehensive eye examination OU was performed at each visit. Testing was performed with optical coherence tomography and optical coherence tomography angiography (optic nerve and macula), as well as visual field examination, on the study eye at baseline and before and after each treatment.
RESULTS


One eye from each of 50 patients was enrolled (10 healthy patients, 26 patients with OHT, and 14 patients with OAG). After administration of LBN there was significantly increased macular VD (0.76% [0.20%-1.33%], P = 0.009) and a trend in increasing peripapillary VD in patients with OAG and patients with OHT. In contrast, after administration of timolol, there were no differences in macular VD, and a decrease in peripapillary VD only was observed in the nasal inferior sector (-0.56% [-1.08% to -0.03%], P = .04) in patients with OAG and patients with OHT. No change in peripapillary or macular VD was observed in the normal subjects (P > .05 for all).
CONCLUSIONS


Topical administration of LBN enhanced macular VD in patients with OAG or patients with OHT. In contrast, timolol administration did not have any effect on VD.",2022,"No change in peripapillary or macular VD was observed in the normal subjects (P >0.05 for all).
","['enhanced macular VD in OAG or OHT patients', 'patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) and normal subjects', 'One eye from each of 50 patients was enrolled (10 healthy, 26 OHT, and 14 OAG', 'Eligible subjects were examined during 6 study visits over 12 weeks']","['LBN', 'latanoprostene bunod (LBN) ophthalmic solution', 'timolol', 'timolol maleate', 'LBN dosed once daily or timolol', 'Latanoprostene Bunod and Timolol']","['Retinal Blood Vessel Density', 'VD', 'peripapillary or macular VD', 'retinal vessel density (VD', 'nasal inferior sector', 'peripapillary VD', 'macular VD']","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4279599', 'cui_str': 'Latanoprostene Bunod'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0035330', 'cui_str': 'Structure of blood vessel of retina'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]",,0.0694653,"No change in peripapillary or macular VD was observed in the normal subjects (P >0.05 for all).
","[{'ForeName': 'Nevin W', 'Initials': 'NW', 'LastName': 'El-Nimri', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Sasan', 'Initials': 'S', 'LastName': 'Moghimi', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Rafaella C', 'Initials': 'RC', 'LastName': 'Penteado', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ghahari', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Diya', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Beijing Tongren Eye Center (D.Y.), Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Brye', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Proudfoot', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Jiun L', 'Initials': 'JL', 'LastName': 'Do', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Camp', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Salcedo', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Rubio', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Weinreb', 'Affiliation': 'From the Hamilton Glaucoma Center (N.W.E., S.M., R.C.P., E.G., N.B., J.P., J.L.D., A.C., M.S., V.R., R.N.W.), Shiley Eye Institute, and the Viterbi Family Department of Ophthalmology, University of California San Diego, La Jolla, California, USA. Electronic address: rweinreb@health.ucsd.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2022.04.022']
988,35533500,"Plasma neurofilament light chain protein as a predictor of days in delirium and deep sedation, mortality and length of stay in critically ill patients.","BACKGROUND


Delirium predicts poor outcomes, however identifying patients with the worst outcomes is challenging. Plasma neurofilament light protein (NfL) is a sensitive indicator of neuronal damage. We undertook an exploratory observational study to determine the association between plasma NfL and delirium in the critically ill.
METHODS


MoDUS was a randomised placebo-controlled delirium trial of simvastatin done in an UK adult general ICU. We measured NfL levels in plasma samples using a Single molecule array (Simoa) platform. We explored associations between patient's plasma NfL levels and number of delirium days, and clinical outcomes. The control group for baseline NfL were preoperative patients undergoing major surgery.
FINDINGS


The majority of critically ill patients already had a high NfL level on admission. Patients with higher plasma NfL levels at days one and three spent more days in delirium or deep sedation. Patients with zero or one day in delirium or deep sedation had day one mean concentrations of 37.8 pg/ml (SD 32.6) compared with 96.5 pg/ml (SD 106.1)) for patients with two days or more, p-value 0.002 linear mixed effects model. Survivors discharged before 14 days had lower mean plasma NfL concentrations compared to those with longer hospital stays and/or who died within six months. The area under ROC curve for predicting death within six months using day one NfL was 0.81 (0.7,0.9).
INTERPRETATION


Measurement of plasma NfL within three days of admission may be useful to identify those patients with worse clinical outcomes, and as an enrichment strategy for future delirium interventional trials in the critically ill.
FUNDING


Alzheimer's Society UK, UK Dementia Research Institute.",2022,Survivors discharged before 14 days had lower mean plasma NfL concentrations compared to those with longer hospital stays and/or who died within six months.,"['critically ill patients already had a high NfL level on admission', 'UK adult general ICU', 'critically ill patients']","['placebo', 'simvastatin', 'Plasma neurofilament light protein (NfL']","['mean plasma NfL concentrations', 'delirium or deep sedation']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0670902', 'cui_str': 'LIGHT Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0670902', 'cui_str': 'LIGHT Protein'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0670902', 'cui_str': 'LIGHT Protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}]",,0.25154,Survivors discharged before 14 days had lower mean plasma NfL concentrations compared to those with longer hospital stays and/or who died within six months.,"[{'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'Page', 'Affiliation': 'Department of Anaesthesia, Intensive Care Unit, Watford General Hospital, Vicarage Road, Watford WD18 0HB, UK; Faculty of Medicine, Imperial College, South Kensington Campus, London SW7 2AZ, UK. Electronic address: valerie.page2@nhs.net.'}, {'ForeName': 'Leiv Otto', 'Initials': 'LO', 'LastName': 'Watne', 'Affiliation': 'Department of Geriatric Medicine, Oslo Delirium Research Group, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Heslegrave', 'Affiliation': 'Department of Neurodegenerative Disease, UCL Queen Square Institute of Neurology, London, UK; UK Dementia Research Institute at UCL, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, The Queen's University of Belfast, Health Sciences Building, Belfast, Northern Ireland, UK; Royal Victoria Hospital, Belfast Health and Social Care Trust, Grosvenor Road, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Sanders', 'Affiliation': 'Sydney Medical School/Central Clinical School, The University of Sydney, NSW 2006, Australia.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Neurodegenerative Disease, UCL Queen Square Institute of Neurology, London, UK; UK Dementia Research Institute at UCL, London, UK; Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Hong Kong Center for Neurodegenerative Diseases, Hong Kong, China.'}]",EBioMedicine,['10.1016/j.ebiom.2022.104043']
989,35533496,A CD4+ TNF+ monofunctional memory T-cell response to BCG vaccination is associated with Mycobacterium tuberculosis infection in infants exposed to HIV.,"BACKGROUND


The immunologic correlates of risk of Mycobacterium tuberculosis (Mtb) infection after BCG vaccination are unknown. The mechanism by which BCG influences the tuberculin skin test (TST) remains poorly understood. We evaluated CD4+ T-cell responses in infants exposed to HIV and uninfected (HEU) who received BCG at birth and examined their role in susceptibility to Mtb infection and influence on TST induration.
METHODS


HEU infants were enrolled in a randomised clinical trial of isoniazid (INH) to prevent Mtb infection in Kenya. We measured mycobacterial antigen-specific Th1 and Th17 cytokine responses at 6-10 weeks of age prior to INH randomisation and compared responses between Mtb infected and uninfected infants. Outcomes at 14 months of age included TST, QuantiFERON-Plus (QFT-Plus), and ESAT-6/CFP-10-specific non-IFN-γ cytokines measured in QFT-Plus supernatants.
FINDINGS


A monofunctional mycobacterial antigen-specific TNF+ CD4+ effector memory (CCR7-CD45RA-) T-cell response at 6-10 weeks of age was associated with Mtb infection at 14 months of age as measured by ESAT-6/CFP-10-specific IFN-γ and non-IFN-γ responses (Odds Ratio 2.26; Confidence Interval 1.27-4.15; P = 0.006). Mycobacterial antigen-specific polyfunctional effector memory Th1 responses at 6-10 weeks positively correlated with TST induration in infants without evidence of Mtb infection at 14 months, an association which was diminished by INH therapy.
INTERPRETATION


Induction of monofunctional TNF+ CD4+ effector memory T-cell responses may be detrimental in TB vaccine development. This study also provides mechanistic insight into the association of BCG-induced immune responses with TST induration and further evidence that TST-based diagnoses of Mtb infection in infants are imprecise.
FUNDING


Thrasher Research Fund.",2022,"Mycobacterial antigen-specific polyfunctional effector memory Th1 responses at 6-10 weeks positively correlated with TST induration in infants without evidence of Mtb infection at 14 months, an association which was diminished by INH therapy.
","['HEU infants', 'infants exposed to HIV', 'infants exposed to HIV and uninfected (HEU) who received']","['BCG', 'isoniazid (INH']","['TST induration', 'ESAT-6/CFP-10-specific IFN-γ and non-IFN-γ responses', 'CD4+ T-cell responses', 'monofunctional mycobacterial antigen-specific TNF+ CD4+ effector memory (CCR7-CD45RA-) T-cell response', 'ESAT-6/CFP-10-specific non-IFN-γ cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0456981', 'cui_str': 'Specific antigen'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0108789', 'cui_str': 'Lymphocyte antigen CD45RA'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.314864,"Mycobacterial antigen-specific polyfunctional effector memory Th1 responses at 6-10 weeks positively correlated with TST induration in infants without evidence of Mtb infection at 14 months, an association which was diminished by INH therapy.
","[{'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Warr', 'Affiliation': 'Department of Medicine, University of Washington, 750 Republican St, Seattle, WA 98109, USA. Electronic address: alex.warr@bcm.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Anterasian', 'Affiliation': 'Department of Pediatrics, University of Washington, 4800 Sand Point Way NE, Seattle, WA 98105, USA.'}, {'ForeName': 'Javeed A', 'Initials': 'JA', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, University of Washington, 750 Republican St, Seattle, WA 98109, USA; Veteran Affairs Puget Sound Healthcare System, 1660 South Columbian Way, Seattle, WA 98108, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave North, E4-200, Seattle, WA 98109, USA; Department of Laboratory Medicine and Pathology, University of Washington, 1959 NE Pacific St, Seattle, WA 98195, USA.'}, {'ForeName': 'Felicia K', 'Initials': 'FK', 'LastName': 'Nguyen', 'Affiliation': 'Department of Medicine, University of Washington, 750 Republican St, Seattle, WA 98109, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maleche-Obimbo', 'Affiliation': 'Department of Paediatrics and Child Health, University of Nairobi, Kenyatta National Hospital, PO Box 20723-00202, Nairobi, Kenya.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Cranmer', 'Affiliation': ""Department of Pediatrics, Emory University and Children's Healthcare of Atlanta, 100 Woodruff Circle, Atlanta, GA 30322, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Matemo', 'Affiliation': 'Kenyatta National Hospital, PO Box 20723-00202, Nairobi, Kenya.'}, {'ForeName': 'Jerphason', 'Initials': 'J', 'LastName': 'Mecha', 'Affiliation': 'Kenyatta National Hospital, PO Box 20723-00202, Nairobi, Kenya.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Kenyatta National Hospital, PO Box 20723-00202, Nairobi, Kenya.'}, {'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'LaCourse', 'Affiliation': 'Department of Medicine, University of Washington, 750 Republican St, Seattle, WA 98109, USA; Department of Global Health, University of Washington, 325 9th Ave, Seattle, WA, 98104, USA.'}, {'ForeName': 'Grace C', 'Initials': 'GC', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Medicine, University of Washington, 750 Republican St, Seattle, WA 98109, USA; Department of Pediatrics, University of Washington, 4800 Sand Point Way NE, Seattle, WA 98105, USA; Department of Global Health, University of Washington, 325 9th Ave, Seattle, WA, 98104, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Hawn', 'Affiliation': 'Department of Medicine, University of Washington, 750 Republican St, Seattle, WA 98109, USA.'}]",EBioMedicine,['10.1016/j.ebiom.2022.104023']
990,35543652,Supraglottic Airway Device to Improve Ventilation Success and Reduce Pulmonary Aspiration during Cardio-Pulmonary Resuscitation by Basic Life Support Rescuers: A Randomized Cross-over Human Cadaver Study.,"OBJECTIVES


Early airway management during cardiopulmonary resuscitation (CPR) prevents aspiration of gastric contents. Endotracheal intubation is the gold standard to protect airways, but supraglottic airway devices (SGA) may provide some protection with less training. Bag-mask ventilation (BMV) is the most common method used by rescuers. We hypothesized that SGA use by first rescuers during CPR could increase ventilation success rate and also decrease intragastric pressure and pulmonary aspiration.
METHODS


We performed a randomized cross-over experimental trial on human cadavers. Protocol A: we assessed the rate of successful ventilation (chest rise), intragastric pressure, and CPR key time metrics. Protocol B: cadaver stomachs were randomized to be filled with 300 mL of either blue or green serum saline solution through a Foley catheter. Each rescuer was randomly assigned to use SGA or BMV during a 5-minute standard CPR period. Then, in a crossover design, the stomach was filled with the second color solution and another 5-minute CPR period was performed using the other airway method. Pulmonary aspiration, defined as the presence of colored solution below the vocal cords, was assessed by a blinded operator using bronchoscopy. A generalized linear mixed model was used for statistical analysis.
RESULTS


Protocol A: Forty-eight rescuers performed CPR on 11 cadavers. Median ventilation success was higher with SGA than BMV: 75.0% (IQR: 59.8-87.3) vs. 34.7% (IQR: 25.0-50.0), ( p  = 0.003). Gastric pressure and differential (maximum minus minimum) gastric pressure were lower in the SGA group: 2.21 mmHg (IQR: 1.66; 2.68) vs. 3.02 mmHg (IQR: 2.02; 4.22) ( p  = 0.02) and 5.70 mmHg (IQR: 4.10; 7.60) vs. 8.05 mmHg (IQR: 5.40; 11.60) ( p  = 0.05). CPR key times were not different between groups. Protocol B: Ten cadavers were included with 20 CPR periods. Aspiration occurred in 2 (20%) SGA procedures and 5 (50%) BMV procedures ( p  = 0.44).
CONCLUSION


Use of SGA by rescuers improved the ventilation success rate, decreased intragastric pressure, and did not affect key CPR metrics. SGA use by basic life support rescuers appears feasible and efficient.",2022,Gastric pressure and differential (maximum minus minimum) gastric pressure were lower in the SGA group: 2.21 mmHg (IQR: 1.66; 2.68) vs. 3.02 mmHg (IQR: 2.02; 4.22) (p = 0.02) and 5.70 mmHg (IQR: 4.10; 7.60) vs. 8.05 mmHg (IQR: 5.40; 11.60) (p = 0.05).,"['Protocol A: Forty-eight rescuers performed CPR on 11 cadavers', 'Protocol B: cadaver stomachs', 'Protocol B: Ten cadavers were included with 20 CPR periods']","['cardiopulmonary resuscitation', 'Endotracheal intubation', 'Bag-mask ventilation (BMV', 'blue or green serum saline solution through a Foley catheter', 'SGA or BMV', 'SGA', 'Supraglottic airway device', 'cardio-pulmonary resuscitation']","['ventilation success', 'CPR key times', 'Gastric pressure and differential (maximum minus minimum) gastric pressure', 'ventilation success rate', 'Median ventilation success', 'ventilation success rate, decreased intragastric pressure', 'rate of successful ventilation (chest rise), intragastric pressure, and CPR key time metrics', 'Aspiration', 'intragastric pressure and pulmonary aspiration']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429216', 'cui_str': 'Gastric pressure'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0700198', 'cui_str': 'Pulmonary aspiration'}]",,0.00928432,Gastric pressure and differential (maximum minus minimum) gastric pressure were lower in the SGA group: 2.21 mmHg (IQR: 1.66; 2.68) vs. 3.02 mmHg (IQR: 2.02; 4.22) (p = 0.02) and 5.70 mmHg (IQR: 4.10; 7.60) vs. 8.05 mmHg (IQR: 5.40; 11.60) (p = 0.05).,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Segond', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bellier', 'Affiliation': 'CNRS TIMC Laboratory, UMR 5525, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Duhem', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sanchez', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Busi', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Deutsch', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Aguilera', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Truan', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'F X', 'Initials': 'FX', 'LastName': 'Koch', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Viglino', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Debaty', 'Affiliation': 'Emergency Department and Mobile Intensive Care Unit, University Hospital of Grenoble Alpes, Grenoble, France.'}]",Prehospital emergency care,['10.1080/10903127.2022.2075994']
991,35545665,"Correction to: Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial.",,2022,,['posttraumatic stress disorder in veterans and active duty military'],"['placebo', 'ketamine']",[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]",[],,0.557553,,"[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA. chadi.abdallah@bcm.edu.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, School of Public Health, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Paulo R', 'Initials': 'PR', 'LastName': 'Shiroma', 'Affiliation': 'Minneapolis VA Medical Center and the Department of Psychiatry University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Purohit', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Brundige', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Murff', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Sherif', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Baltutis', 'Affiliation': 'Minneapolis VA Medical Center and the Department of Psychiatry University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Martini', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ismene L', 'Initials': 'IL', 'LastName': 'Petrakis', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Burson', 'Affiliation': 'Department of Behavioral Health, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Guthmiller', 'Affiliation': 'Department of Pain Management, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Argelio L', 'Initials': 'AL', 'LastName': 'López-Roca', 'Affiliation': 'Department of Behavioral Health, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Karl A', 'Initials': 'KA', 'LastName': 'Lautenschlager', 'Affiliation': 'Department of Pain Management, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCallin', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Hoch', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Alexandar', 'Initials': 'A', 'LastName': 'Timchenko', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Sergio E', 'Initials': 'SE', 'LastName': 'Souza', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Bryant', 'Affiliation': 'Department of Rehabilitation, Brooke Army Medical Center, Joint Base San Antonio - Fort Sam Houston, Houston, TX, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiology Research and Information Center, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Health, Durham, NC, USA.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-022-01339-9']
992,35551291,Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a phase 1 clinical trial.,"HIV-1 therapy with single or dual broadly neutralizing antibodies (bNAbs) has shown viral escape, indicating that at least a triple bNAb therapy may be needed for robust suppression of viremia. We performed a two-part study consisting of a single-center, randomized, double-blind, dose-escalation, placebo-controlled first-in-human trial of the HIV-1 V2-glycan-specific antibody PGDM1400 alone or in combination with the V3-glycan-specific antibody PGT121 in 24 adults without HIV in part 1, as well as a multi-center, open-label trial of the combination of PGDM1400, PGT121 and the CD4-binding-site antibody VRC07-523LS in five viremic adults living with HIV not on antiretroviral therapy (ART) in part 2 ( NCT03205917 ). The primary endpoints were safety, tolerability and pharmacokinetics for both parts and antiviral activity among viremic adults living with HIV and not on ART for part 2 of the study. The secondary endpoints were changes in CD4 +  T cell counts and development of HIV-1 sequence variations associated with PGDM1400, PGT121 and VRC07-523LS resistance in part 2. Intravenously administered PGDM1400 was safe and well-tolerated at doses up to 30 mg kg -1  and when given in combination with PGT121 and VRC07-523LS. A single intravenous infusion of 20 mg kg -1  of each of the three antibodies reduced plasma HIV RNA levels in viremic individuals by a maximum mean of 2.04 log 10  copies per ml; however, viral rebound occurred in all participants within a median of 20 days after nadir. Rebound viruses demonstrated partial to complete resistance to PGDM1400 and PGT121 in vitro, whereas susceptibility to VRC07-523LS was preserved. Viral rebound occurred despite mean VRC07-523LS serum concentrations of 93 µg ml -1 . The trial met the pre-specified endpoints. Our data suggest that future bNAb combinations likely need to achieve broad antiviral activity, while also maintaining high serum concentrations, to mediate viral control.",2022,"A single intravenous infusion of 20 mg kg -1  of each of the three antibodies reduced plasma HIV RNA levels in viremic individuals by a maximum mean of 2.04 log 10  copies per ml; however, viral rebound occurred in all participants within a median of 20 days after nadir.","['24 adults without HIV in part 1, as well as a multi-center, open-label trial of the combination of PGDM1400, PGT121 and the CD4-binding-site antibody VRC07-523LS in five viremic adults living with HIV not on antiretroviral therapy (ART) in part 2 ( NCT03205917 ']","['PGDM1400', 'triple combination broadly neutralizing monoclonal antibody therapy against HIV-1', 'placebo', 'HIV-1 therapy with single or dual broadly neutralizing antibodies (bNAbs', 'HIV-1 V2-glycan-specific antibody PGDM1400 alone or in combination with the V3-glycan-specific antibody PGT121']","['safety, tolerability and pharmacokinetics for both parts and antiviral activity', 'safe and well-tolerated', 'changes in CD4 +  T cell counts and development of HIV-1 sequence variations associated with PGDM1400, PGT121 and VRC07-523LS resistance', 'viral rebound', 'Safety and antiviral activity', 'plasma HIV RNA levels', 'mean VRC07-523LS serum concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0005456', 'cui_str': 'Binding Site'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C5197773', 'cui_str': 'Cross-Neutralizing Antibodies'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",24.0,0.456462,"A single intravenous infusion of 20 mg kg -1  of each of the three antibodies reduced plasma HIV RNA levels in viremic individuals by a maximum mean of 2.04 log 10  copies per ml; however, viral rebound occurred in all participants within a median of 20 days after nadir.","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Julg', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Kshitij', 'Initials': 'K', 'LastName': 'Wagh', 'Affiliation': 'Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.'}, {'ForeName': 'Sabrina C', 'Initials': 'SC', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Zash', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Victoria E K', 'Initials': 'VEK', 'LastName': 'Walker-Sperling', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Ophel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Maxfield', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Abbink', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Martina S', 'Initials': 'MS', 'LastName': 'Wesley', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Hassell', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Huub C', 'Initials': 'HC', 'LastName': 'Gelderblom', 'Affiliation': 'International AIDS Vaccine Initiative, New York, NY, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'deCamp', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Bryan T', 'Initials': 'BT', 'LastName': 'Mayer', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Monica W', 'Initials': 'MW', 'LastName': 'Gerber', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Elena E', 'Initials': 'EE', 'LastName': 'Giorgi', 'Affiliation': 'Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Gama', 'Affiliation': 'Vaccine Research Center, National Institute of Health, Bethesda, MD, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Koup', 'Affiliation': 'Vaccine Research Center, National Institute of Health, Bethesda, MD, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Monczor', 'Affiliation': 'Houston AIDS Research Team, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Lupo', 'Affiliation': 'Houston AIDS Research Team, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Charlotte-Paige', 'Initials': 'CP', 'LastName': 'Rolle', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Arduino', 'Affiliation': 'Houston AIDS Research Team, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Bette', 'Initials': 'B', 'LastName': 'Korber', 'Affiliation': 'Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA. dbarouch@bidmc.harvard.edu.'}]",Nature medicine,['10.1038/s41591-022-01815-1']
993,35551290,Empagliflozin add-on therapy to closed-loop insulin delivery in type 1 diabetes: a 2 × 2 factorial randomized crossover trial.,"There is a need to optimize closed-loop automated insulin delivery in type 1 diabetes. We assessed the glycemic efficacy and safety of empagliflozin 25 mg d -1  as add-on therapy to insulin delivery with a closed-loop system. We performed a 2 × 2 factorial randomized, placebo-controlled, crossover two-center trial in adults, assessing 4 weeks of closed-loop delivery versus sensor-augmented pump (SAP) therapy and empagliflozin versus placebo. The primary outcome was time spent in the glucose target range (3.9-10.0 mmol l -1 ). Primary comparisons were empagliflozin versus placebo in each of closed-loop or SAP therapy; the remaining comparisons were conditional on its significance. Twenty-four of 27 randomized participants were included in the final analysis. Compared to placebo, empagliflozin improved time in target range with closed-loop therapy by 7.2% and in SAP therapy by 11.4%. Closed-loop therapy plus empagliflozin improved time in target range compared to SAP therapy plus empagliflozin by 6.1% but by 17.5% for the combination of closed-loop therapy and empagliflozin compared to SAP therapy plus placebo. While no diabetic ketoacidosis or severe hypoglycemia occurred during any intervention, uncomplicated ketosis events were more common on empagliflozin. Empagliflozin 25 mg d -1  added to automated insulin delivery improves glycemic control but increases ketone concentration and ketosis compared to placebo.",2022,"Compared to placebo, empagliflozin improved time in target range with closed-loop therapy by 7.2% and in SAP therapy by 11.4%.","['Twenty-four of 27 randomized participants were included in the final analysis', 'type 1 diabetes']","['Empagliflozin', 'SAP therapy plus empagliflozin', 'empagliflozin versus placebo', 'SAP therapy plus placebo', 'placebo, empagliflozin', 'closed-loop delivery versus sensor-augmented pump (SAP) therapy and empagliflozin versus placebo', 'empagliflozin', 'placebo', 'Closed-loop therapy plus empagliflozin', 'Empagliflozin 25\u2009mg']","['glycemic efficacy and safety', 'time spent in the glucose target range', 'diabetic ketoacidosis or severe hypoglycemia', 'uncomplicated ketosis events', 'ketone concentration and ketosis']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0427750', 'cui_str': 'Ketone concentration, test strip measurement'}]",27.0,0.167003,"Compared to placebo, empagliflozin improved time in target range with closed-loop therapy by 7.2% and in SAP therapy by 11.4%.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Leif Erik', 'Initials': 'LE', 'LastName': 'Lovblom', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cardinez', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Gouchie-Provencher', 'Affiliation': 'The Research Institute of McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Orszag', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Tsoukas', 'Affiliation': 'The Research Institute of McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'C Marcelo', 'Initials': 'CM', 'LastName': 'Falappa', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Jafar', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Ghanbari', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Eldelekli', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Yale', 'Affiliation': 'The Research Institute of McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada. Bruce.Perkins@sinaihealth.ca.'}]",Nature medicine,['10.1038/s41591-022-01805-3']
994,35533737,Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effect of inspiratory muscle training (IMT) on physical fitness in children with Down syndrome (DS).
DESIGN


Randomized control trial.
SETTING


The study was conducted in a private physical therapy center.
PARTICIPANTS


Forty boys and girls with DS aged between 7 and 10 years were enrolled in this study (N=40). They were randomly and equally divided into 2 groups (A and B).
INTERVENTIONS


All participants received 30 minutes of aerobic exercise training 3 times per week for 12 weeks, whereas group B received an additional 30 minutes of IMT before each aerobic exercise session.
MAIN OUTCOMES MEASURES


Physical fitness of the participants was assessed before and after the treatment using the 6-minute walk test (6MWT), Gio Digital Pressure Gauge, and Brockport Physical Fitness Test.
RESULTS


This study measured maximal inspiratory pressure; maximal expiratory pressure; submaximal aerobic endurance using the 6MWT; and strength and endurance using the curl-up, dumbbell press, trunk lift, standing long jump, seated push-up, pull-up, flexed-arm hang, and back-saver sit and reach tests.
CONCLUSIONS


There was a significant improvement in the physical fitness of the children who underwent aerobic exercise. However, children who received IMT and aerobic exercise training demonstrated even more significant improvements in physical fitness than those who received aerobic exercise training only.",2022,There was a significant improvement in the physical fitness of the children who underwent aerobic exercise.,"['children with Down syndrome (DS', 'Children with Down Syndrome', 'The study was conducted in a private physical therapy centre', 'Forty boys and girls with DS aged between 7 and 10 years']","['additional 30 min of IMT before each aerobic exercise session', 'IMT and aerobic exercise training', 'inspiratory muscle training (IMT', 'Inspiratory Muscle Training and Physical Fitness', 'aerobic exercise training']","['Physical fitness', 'physical fitness', 'maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), submaximal aerobic endurance using the 6MWT, strength, and endurance using the curl-up, dumbbell press, trunk lift, standing long jump, seated push-up, pull-up, flexed-arm hang, and back saver sit and reach tests', 'six-minute walk test (6MWT), Gio Digital Pressure Gauge, and Brockport physical fitness test (BPFT']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}]",40.0,0.0306043,There was a significant improvement in the physical fitness of the children who underwent aerobic exercise.,"[{'ForeName': 'Mohamed Ali', 'Initials': 'MA', 'LastName': 'Elshafey', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Reham Saeed', 'Initials': 'RS', 'LastName': 'Alsakhawi', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt; Department of Rehabilitation Sciences, College of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia. Electronic address: rsm211_pt@yahoo.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2022.04.005']
995,35533724,Morphine and clinical outcomes in patients with ST segment elevation myocardial infarction treated with fibrinolytic and antiplatelet therapy: Insights from the TREAT trial.,"BACKGROUND


Morphine is commonly used to relieve pain, anxiety and dyspnea in STEMI but it lowers blood pressure and delays the activity of oral antiplatelet agents. The impact of morphine on clinical outcomes remains unknown. This analysis was performed to determine if morphine use was associated with increased risk of adverse clinical events among STEMI patients treated with fibrinolytic therapy and clopidogrel or ticagrelor.
METHODS


In the Ticagrelor in Patients with ST Elevation Myocardial Infarction Treated with Pharmacological Thrombolysis (TREAT) study, 3799 STEMI patients treated with fibrinolysis were randomized to receive clopidogrel or ticagrelor. Morphine use was left to the discretion of the treating physicians. In this pre-specified analysis, we evaluated clinical outcomes based on the use and timing of morphine administration. Outcomes were stratified by randomized treatment group. Multivariable analysis was performed using Inverse Probability Treatment Weighting (IPTW) weighting.
RESULTS


Morphine was used in 53% of patients. After adjustment using IPTW weighting, morphine use was associated with higher hazard of reinfarction at 7 days (HR 4.9, P = .0006) and 30 days (HR 1.7, P = .04), and lower hazard of major bleeding (HR 0.37, P = .006). There was no significant difference in mortality at any time point.
CONCLUSIONS


Among patients with STEMI treated with fibrinolytic therapy, morphine use was associated with a higher risk of early reinfarction and a lower risk of major bleeding but no difference in mortality.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02298088.",2022,"There was no significant difference in mortality at any time point.
","['Patients with ST segment elevation Myocardial Infarction Treated with Fibrinolytic and Antiplatelet Therapy', 'Patients', '3,799 STEMI patients treated with fibrinolysis']","['morphine', 'fibrinolytic therapy, morphine', 'Ticagrelor', 'Morphine', 'fibrinolytic therapy and clopidogrel or ticagrelor', 'clopidogrel or ticagrelor', 'Pharmacological Thrombolysis (TREAT']","['mortality', 'lower hazard of major bleeding', 'hazard of reinfarction', 'pain, anxiety and dyspnea in STEMI', 'higher risk of early reinfarction and a lower risk of major bleeding', 'blood pressure', 'risk of adverse clinical events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",3799.0,0.117116,"There was no significant difference in mortality at any time point.
","[{'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Cantor', 'Affiliation': 'Department of Medicine, Southlake Regional Health Centre, University of Toronto, 581 Davis Drive, Newmarket, Toronto, Ontario L3Y 2P6, Canada. Electronic address: cantorw@rogers.com.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Canadian Heart Research Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Academic Research Organization (ARO), Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Lavi', 'Affiliation': 'Department of Medicine, London Health Sciences Centre, Western University, London, Ontario, Canada.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Department of Medicine, Cardiovascular Services, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Dehghani', 'Affiliation': 'Department of Medicine, Prairie Vascular Research Network and Saskatchewan Health Authority, University of Saskatchewan, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Carlos D', 'Initials': 'CD', 'LastName': 'Tajer', 'Affiliation': 'Department of Medicine, Hospital de Alta Complejidad El Cruce, Buenos Aires, Argentina.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Department of Medicine, Duke Clinical Research Institute, Durham, NC, United States; Department of Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Diogo D F', 'Initials': 'DDF', 'LastName': 'Moia', 'Affiliation': 'Clinical Operations, Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Department of Medicine, Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': 'Department of Medicine, Emergency Cardiology Department, Institute of Cardiology, Kiev, Ukraine.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Averkov', 'Affiliation': 'Department of Medicine, Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Brass', 'Affiliation': 'Department of Medicine, CK Hui Heart Centre, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Lutchmedial', 'Affiliation': 'Department of Medicine, New Brunswick Heart Centre, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': 'Department of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Clinical Operations, Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Leopoldo S', 'Initials': 'LS', 'LastName': 'Piegas', 'Affiliation': 'Department of Medicine, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Department of Medicine, Duke Clinical Research Institute, Durham, NC, United States.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Department of Medicine, Canadian Heart Research Centre (CHRC) and Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]",American heart journal,['10.1016/j.ahj.2022.05.005']
996,35537970,Effects of Thermal Softening of Double-Lumen Endobronchial Tubes on the Prevention of Postoperative Sore Throat in Smokers: A Randomized Controlled Trial.,"OBJECTIVE


Tracheal intubation-related complications, such as postoperative sore throat (POST), hoarseness, and vocal cords injuries, are not uncommon. It is well known that thermal softening of double-lumen endobronchial tubes (DLTs) has been used to prevent these events from happening in non-smokers; however, no study has ever assessed the effects of thermal softening of DLTs in smokers undergoing one-lung anesthesia. The authors aimed to investigate whether thermal softening of DLT can achieve a better effect in preventing POST.
DESIGN


A total of 258 smokers scheduled for one-lung anesthesia were randomly assigned to 1 of the following 2 groups: (1) group C (non-thermal softening group) and (2) group T (DLTs were placed in 40°C 0.9% saline for 10 minutes). Incidence and severity of POST and hoarseness were assessed until 48 hours after surgery. Vocal cords were examined using laryngoscope before intubation and immediately after extubation. Patients' hemodynamic change at intubation and extubation was recorded. The primary outcomes were the incidence and severity of POST. The secondary outcomes were the incidence and severity of hoarseness, vocal cords injuries, and patients' hemodynamic change at intubation and extubation.
MEASUREMENTS AND MAIN RESULTS


Sore throat and vocal cord injuries occurred less frequently in the thermal softening group than in the control group (31/129 v 60/129, p < 0.01; 21/129 v 49/129, p < 0.001; 12/129 v 35/129, p < 0.001 for sore throat; 14/70 v 27/70, risk ratio (95% confidence interval): 0.52 (0.30-0.90), p = 0.025 for sore throat; 5/129 v 52/129, p < 0.05 for vocal cord injuries).
CONCLUSION


Thermal softening of DLTs significantly reduced the incidence and severity of DLTs intubation-related POST within 72 hours after extubation.",2022,"Sore throat and vocal cord injuries occurred less frequently in the thermal softening group than in the control group (31/129 v 60/129, p < 0.01; 21/129 v 49/129, p < 0.001; 12/129 v 35/129, p < 0.001 for sore throat; 14/70 v 27/70, risk ratio (95% confidence interval): 0.52 (0.30-0.90), p = 0.025 for sore throat; 5/129 v 52/129, p < 0.05 for vocal cord injuries).
","['258 smokers scheduled for one-lung anesthesia', 'Postoperative Sore Throat in Smokers', 'smokers undergoing one-lung anesthesia']","['DLT', 'group C (non-thermal softening group) and (2) group T ', 'Thermal Softening of Double-Lumen Endobronchial Tubes']","['hemodynamic change at intubation and extubation', 'Sore throat and vocal cord injuries', 'incidence and severity of DLTs intubation-related POST', 'incidence and severity of POST', ""incidence and severity of hoarseness, vocal cords injuries, and patients' hemodynamic change at intubation and extubation"", 'Incidence and severity of POST and hoarseness']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}]","[{'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",258.0,0.137554,"Sore throat and vocal cord injuries occurred less frequently in the thermal softening group than in the control group (31/129 v 60/129, p < 0.01; 21/129 v 49/129, p < 0.001; 12/129 v 35/129, p < 0.001 for sore throat; 14/70 v 27/70, risk ratio (95% confidence interval): 0.52 (0.30-0.90), p = 0.025 for sore throat; 5/129 v 52/129, p < 0.05 for vocal cord injuries).
","[{'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Bi', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China.'}, {'ForeName': 'Jipeng', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China.'}, {'ForeName': 'Qianxiu', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China. Electronic address: zhangxia08292020@163.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2022.04.017']
997,35543710,Effects of Pulmonary Rehabilitation on Systemic Inflammation and Exercise Capacity in Bronchiectasis: A Randomized Controlled Trial.,"INTRODUCTION


Bronchiectasis is a chronic condition that is becoming a global health concern.
OBJECTIVE


To examine the effects of pulmonary rehabilitation (PR) on systemic inflammation, exercise capacity, and quality of life in participants with bronchiectasis.
METHODS


Participants were randomized to receive PR (outpatient, three weekly sessions for 3 months) or control intervention (usual care + airway clearance therapy + breathing exercises). Data on laboratory (fibrinogen level) and patient-centered outcomes such as physical fitness [6-min walk test (6MWT)] and quality of life were collected.
RESULTS


A total of 41 participants were evaluated (20 in the intervention group and 21 in the control group). The magnitude of change between baseline and the end of study was greater in the PR group than in the control group-the 6MWT distance increased by a mean of 54 m (54 vs 12 m; p < 0.01), fibrinogen showed a significant reduction (fibrinogen - 92.8 versus - 47.1 mg/dl; p < 0.01), and quality of life improved according to Saint George's Respiratory Questionnaire (SGRQ) (- 7.5 vs 3.2; p < 0.01), which exceeded the minimal clinically important difference of 4 points.
CONCLUSION


PR effectively improved physical fitness, quality of life, and the degree of systemic inflammation, as reflected by changes in 6 MWT, fibrinogen levels and SGRQ scores. This study supports the inclusion of people with bronchiectasis in supervised PR programs.",2022,"The magnitude of change between baseline and the end of study was greater in the PR group than in the control group-the 6MWT distance increased by a mean of 54 m (54 vs 12 m; p < 0.01), fibrinogen showed a significant reduction (fibrinogen - 92.8 versus - 47.1 mg/dl; p < 0.01), and quality of life improved according to Saint George's Respiratory Questionnaire (SGRQ) (- 7.5 vs 3.2; p < 0.01), which exceeded the minimal clinically important difference of 4 points.
","['participants with bronchiectasis', 'A total of 41 participants were evaluated (20 in the intervention group and 21 in the control group', 'Bronchiectasis', 'people with bronchiectasis in supervised PR programs', 'Participants']","['Pulmonary Rehabilitation', 'PR', 'control intervention (usual care\u2009+\u2009airway clearance therapy\u2009+\u2009breathing exercises', 'pulmonary rehabilitation (PR']","['physical fitness, quality of life, and the degree of systemic inflammation', ""quality of life improved according to Saint George's Respiratory Questionnaire (SGRQ"", 'Systemic Inflammation and Exercise Capacity', '6MWT distance', 'laboratory (fibrinogen level) and patient-centered outcomes such as physical fitness [6-min walk test (6MWT)] and quality of life', '6 MWT, fibrinogen levels and SGRQ scores', 'systemic inflammation, exercise capacity, and quality of life']","[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",41.0,0.0414425,"The magnitude of change between baseline and the end of study was greater in the PR group than in the control group-the 6MWT distance increased by a mean of 54 m (54 vs 12 m; p < 0.01), fibrinogen showed a significant reduction (fibrinogen - 92.8 versus - 47.1 mg/dl; p < 0.01), and quality of life improved according to Saint George's Respiratory Questionnaire (SGRQ) (- 7.5 vs 3.2; p < 0.01), which exceeded the minimal clinically important difference of 4 points.
","[{'ForeName': 'Amanda Souza', 'Initials': 'AS', 'LastName': 'Araújo', 'Affiliation': 'Department of Surgery, Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Mara Rúbia', 'Initials': 'MR', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Surgery, Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Lomonaco', 'Affiliation': 'Department of Medicine, Federal University of Ceara, Fortaleza, Ceará, 60140000, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lundgren', 'Affiliation': 'Hospital Otávio de Freitas, Recife, PE, Brasil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Mesquita', 'Affiliation': 'Department of Physiotherapy, Federal University of Ceara, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Eanes Delgado Barros', 'Initials': 'EDB', 'LastName': 'Pereira', 'Affiliation': 'Department of Medicine, Federal University of Ceara, Fortaleza, Ceará, 60140000, Brazil. eanes@fortalnet.com.br.'}]",Lung,['10.1007/s00408-022-00540-3']
998,35549926,Danger appraisal and pathogen-avoidance mechanisms in stigma towards severe mental illness: the mediating role of affective responses.,"BACKGROUND


Stereotypes of dangerousness are common predictors of stigmatising attitudes towards Severe Mental Illness (SMI). However less is known about pathogen avoidance mechanisms underlying stigma towards SMI, specially in samples of non-industrialised societies of Latin America and the Caribbean. The primary aim of this study was to examine pathogen-disgust sensitivity and danger appraisal mechanisms in responses of stigma towards SMI.
METHODS


Cross-sectional design with convenience sampling. Using an online survey, volunteers at the Universidad del Norte in Colombia (N = 271) provided their sociodemographic data and completed the Three-Domain Disgust Scale (TDDS). Participants were randomised to different descriptions of someone with SMI that varied in terms of aggressiveness (with and without danger) and causes of the SMI. Then, following the attribution questionnaire (AQ-27), respondents reported affective and discriminatory responses to the person in the description.
RESULTS


Increased disgust sensitivity to pathogen stimuli resulted in stronger reports of anger (β = .14; p = .03), and fear (β = 0.27; p < 0.001). The relationship between disgust sensitivity and discriminatory responses was indirectly mediated by fear towards SMI (Bootstrapped CI =-.04,-.009). Dangerousness attributions in the description of SMI predicted stronger feelings of anger (β = .23; p = 0.001) and fear (β = .40; p < .001), as well increased support for coercion-segregation of SMI (β = .34; p = 0.04), but less intentions to help (β = -.26; p = 0.003). The relationship between dangerousness and support for coercion was mediated by fear (Bootstrapped CI = .72, 1.37) and anger (Bootstrapped CI = .06, .44), whereas pity (Bootstrapped CI = .03, .38) and fear (Bootstrapped CI = -1.39, -.69) mediated responses of support for coercion-segregation of SMI. Attributions about causes and personal responsibility were not significantly linked to stigma towards SMI (p > 0.05).
CONCLUSIONS


Findings suggested that pathogen avoidance and danger appraisal systems interplay in the generation of discriminatory behaviour towards SMI. Anti-stigma programs and policy makers would benefit from introducing strategies that challenge stereotypes of dangerousness and unpredictability by promoting positive contact with people with SMI.",2022,"Attributions about causes and personal responsibility were not significantly linked to stigma towards SMI (p > 0.05).
",['stigma towards severe mental illness'],[],"['stigma towards SMI', 'Attributions about causes and personal responsibility']","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",,0.0866892,"Attributions about causes and personal responsibility were not significantly linked to stigma towards SMI (p > 0.05).
","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Chamorro Coneo', 'Affiliation': 'Psychology department, Universidad del Norte, Barranquilla-Atlántico, Colombia. chamorroa@uninorte.edu.co.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Aristizabal Diazgranados', 'Affiliation': 'Psychology department, Universidad del Norte, Barranquilla-Atlántico, Colombia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hoyos de Los Rios', 'Affiliation': 'Psychology department, Universidad del Norte, Barranquilla-Atlántico, Colombia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Aguilar Santander', 'Affiliation': 'Psychology department, Universidad del Norte, Barranquilla-Atlántico, Colombia.'}]",BMC psychiatry,['10.1186/s12888-022-03951-x']
999,35001410,"The effects of saffron (Crocus sativus L.) in conjunction with concurrent training on body composition, glycaemic status, and inflammatory markers in obese men with type 2 diabetes mellitus: A randomized double-blind clinical trial.","AIMS


Chronic inflammation is one of the major challenges in the management of obesity and type 2 diabetes mellitus (T2DM). Our primary aim was to assess the anti-inflammatory effects of Saffron (Crocus sativus L.) supplementation and concurrent training in obese men with T2DM.
METHODS


Sixty obese men with T2DM (age = 39 ± 5 years; body mass = 93.9 ± 6 kg) were randomly assigned to four groups; concurrent training + placebo (CT; n = 15), saffron supplementation (S; n = 15), concurrent training + saffron supplementation (CTS; n = 15), or control (CON; n = 15). The participants in the CT group performed concurrent training (resistance + aerobic) three times per week for 12 weeks and received daily one pill of placebo (maltodextrin); the participants in the S group supplemented with one pill of 100 mg of saffron daily, and the participants in the CTS group participated in both saffron and training intervention while CON group continued regular lifestyle (no training and no supplementation). Inflammatory markers, body composition (evaluated by a multi-frequency bioelectrical impedance device; Jawon X-Contact 356), and metabolic profile were evaluated before and after interventions.
RESULTS


All three interventions significantly (P < .05) decreased TNF-α (CT = -4.22, S = -1.91, CTS = -9.69 pg/mL), hs-CRP (CT = -0.13, S = -0.1, CTS = -0.32 ng/mL), IL-6 (CT = -6.84, S = -6.36, CTS = -13.55 pg/mL), IL-1β (CT = -8.85, S = -6.46, CTS = -19.8 pg/mL), FBG (CT = -6.97, S = -2.45, CTS = -13.86 mg/dL), insulin (CT = -0.13, S = -0.03, CTS = -0.21 mU/L), HOMA-IR (CT = -0.12, S = -0.04, CTS = -0.21), HbA1c (CT = -0.17, S = -0.11, CTS = -0.26%), and increased IL-10 (CT = 1.09, S = 0.53, CTS = 2.27 pg/mL) concentrations. There was a positive correlation between changes in BFP with hs-CRP, IL-6, IL-1β and TNF-α, and IL-10 concentrations across the intervention groups. Additionally, significant differences were observed between the changes for all variables in the CTS group compared to CT, S and CON groups (P < .05).
CONCLUSION


It seems that an interaction of saffron supplementation and concurrent training has more efficient effects on anti-inflammatory status compared to saffron supplementation or concurrent training alone.",2022,"There was a positive correlation between changes in BFP with hs-CRP, IL-6, IL-1β, and TNF-α, and IL-10 concentrations across the intervention groups.","['obese men with type 2 diabetes mellitus', 'obese men with T2DM', 'Sixty obese men with T2DM (age\u2009=\u200939\u2009±\u20095\u2009years; body mass\u2009= 93.9\u2009± 6\u2009kg']","['IL-1β (CT', 'CTS group participated in both saffron and training intervention while CON group continued regular lifestyle (no training or no supplementation', 'IL-6', 'concurrent training + placebo (CT; n\u2009=\u200915), saffron supplementation (S; n\u2009=\u200915), concurrent training + saffron supplementation (CTS; n\u2009=\u200915), or control (CON', 'concurrent training (resistance + aerobic) three times per week for 12 weeks and received daily one pill of placebo (maltodextrin); the participants in the S group supplemented with one pill of 100 mg of saffron', 'Saffron (Crocus sativus L', 'Saffron (Crocus sativus L.) supplementation and concurrent training']","['body composition, glycemic status, and inflammatory markers', 'IL-10', 'HbA1c', 'TNF-α (CT ', 'Inflammatory markers, body composition', 'FBG', 'BFP with hs-CRP, IL-6, IL-1β, and TNF-α, and IL-10 concentrations', 'HOMA-IR (CT']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0946614', 'cui_str': 'Saffron Crocus'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0045933', 'cui_str': '2-benzyl-3-formylpropanoic acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",60.0,0.0885942,"There was a positive correlation between changes in BFP with hs-CRP, IL-6, IL-1β, and TNF-α, and IL-10 concentrations across the intervention groups.","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rashidlamir', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Seyyed Reza', 'Initials': 'SR', 'LastName': 'Attarzadeh Hosseini', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'School of Nutrition and Dietetics, Acadia University, Wolfville, Nova Scotia, Canada.'}]",British journal of clinical pharmacology,['10.1111/bcp.15222']
1000,34960106,"Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial.","Fat-soluble vitamin deficiency remains a challenge in cystic fibrosis (CF), chronic pancreatitis, and biliary atresia. Liposomes and cyclodextrins can enhance their bioavailability, thus this multi-center randomized placebo-controlled trial compared three-month supplementation of fat-soluble vitamins in the form of liposomes or cyclodextrins to medium-chain triglycerides (MCT) in pancreatic-insufficient CF patients. The daily doses were as follows: 2000 IU of retinyl palmitate, 4000 IU of vitamin D3, 200 IU of RRR-α-tocopherol, and 200 µg of vitamin K2 as menaquinone-7, with vitamin E given in soybean oil instead of liposomes. All participants received 4 mg of β-carotene and 1.07 mg of vitamin K1 to ensure compliance with the guidelines. The primary outcome was the change from the baseline of all-trans-retinol and 25-hydroxyvitamin D3 concentrations and the percentage of undercarboxylated osteocalcin. Out of 75 randomized patients ( n  = 28 liposomes,  n  = 22 cyclodextrins, and  n  = 25 MCT), 67 completed the trial (89%;  n  = 26 liposomes,  n  = 18 cyclodextrins, and  n  = 23 MCT) and had a median age of 22 years (IQR 19-28), body mass index of 20.6 kg/m 2  [18.4-22.0], and forced expiratory volume in 1 s of 65% (44-84%). The liposomal formulation of vitamin A was associated with the improved evolution of serum all-trans-retinol compared to the control (median +1.7 ng/mL (IQR -44.3-86.1) vs. -38.8 ng/mL (-71.2-6.8),  p  = 0.028). Cyclodextrins enhanced the bioavailability of vitamin D3 (+9.0 ng/mL (1.0-17.0) vs. +3.0 ng/mL (-4.0-7.0),  p  = 0.012) and vitamin E (+4.34 µg/mL (0.33-6.52) vs. -0.34 µg/mL (-1.71-2.15),  p  = 0.010). Liposomes may augment the bioavailability of vitamin A and cyclodextrins may strengthen the supplementation of vitamins D3 and E relative to MCT in pancreatic-insufficient CF but further studies are required to assess liposomal vitamin E (German Clinical Trial Register number DRKS00014295, funded from EU and Norsa Pharma).",2021,The liposomal formulation of vitamin A was associated with the improved evolution of serum all-trans-retinol compared to the control (median +1.7 ng/mL (IQR -44.3-86.1) vs. -38.8,"['75 randomized patients ( n  = 28 liposomes,  n  = 22 cyclodextrins, and  n  = 25 MCT), 67 completed the trial (89%;  n  = 26 liposomes,  n  = 18 cyclodextrins, and  n  = 23 MCT) and had a median age of 22 years (IQR 19-28), body mass index of 20.6 kg/m 2  [18.4-22.0', 'Cystic Fibrosis', 'cystic fibrosis (CF), chronic pancreatitis, and biliary atresia']","['placebo', 'β-carotene and 1.07 mg of vitamin K1', 'Liposomes and cyclodextrins', 'retinyl palmitate, 4000 IU of vitamin D3, 200 IU of RRR-α-tocopherol, and 200 µg of vitamin K2 as menaquinone-7, with vitamin E given in soybean oil instead of liposomes', 'Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides']","['bioavailability of vitamin D3', 'change from the baseline of all-trans-retinol and 25-hydroxyvitamin D3 concentrations and the percentage of undercarboxylated osteocalcin', 'improved evolution of serum all-trans-retinol', 'vitamin E']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0010558', 'cui_str': 'Cyclodextrins'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C0005411', 'cui_str': 'Congenital biliary atresia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0031862', 'cui_str': 'Vitamin K 1'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0010558', 'cui_str': 'Cyclodextrins'}, {'cui': 'C0073115', 'cui_str': 'Vitamin A palmitate'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0078382', 'cui_str': 'vitamin MK 7'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0556111', 'cui_str': 'Fat soluble vitamin supplementation'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}]",75.0,0.595765,The liposomal formulation of vitamin A was associated with the improved evolution of serum all-trans-retinol compared to the control (median +1.7 ng/mL (IQR -44.3-86.1) vs. -38.8,"[{'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Nowak', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Sobkowiak', 'Affiliation': 'Department of Pneumonology, Allergology and Clinical Immunology, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Sławomira', 'Initials': 'S', 'LastName': 'Drzymała-Czyż', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Krzyżanowska-Jankowska', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sapiejka', 'Affiliation': 'The Specialist Centre for Medical Care of Mother and Child, Polanki 119, 80-308 Gdańsk, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Skorupa', 'Affiliation': 'Department of Lung Diseases, Institute for Tuberculosis and Lung Diseases, Plocka 26, 01-138 Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Pogorzelski', 'Affiliation': 'Department of Pneumology and Cystic Fibrosis, Institute of Tuberculosis and Lung Diseases, Rudnika 3, 34-700 Rabka-Zdroj, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Nowicka', 'Affiliation': 'Department of Pulmonology, Allergology and Respiratory Oncology, Poznan University of Medical Sciences, Szamarzewskiego 84, 60-569 Poznan, Poland.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Wojsyk-Banaszak', 'Affiliation': 'Department of Pneumonology, Allergology and Clinical Immunology, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Kurek', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zielińska-Psuja', 'Affiliation': 'Department of Toxicology, Poznan University of Medical Sciences, Dojazd 30, 60-631 Poznan, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Lisowska', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}]",Nutrients,['10.3390/nu13124554']
1001,35532913,"Safety, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome: A Phase 1b Randomized Clinical Trial.","Importance


Individuals with Down syndrome (DS) are at high risk of developing Alzheimer disease due to an increased dose of the amyloid precursor protein gene, APP, which leads to increased levels of full-length APP and its products, including amyloid-β (Aβ). The liposome-based antiamyloid ACI-24 vaccine is intended to treat neurological disorders caused by misfolded Aβ pathological protein. However, the safety, tolerability, and immunogenicity of the ACI-24 vaccine among adults with DS have not been fully examined.
Objective


To assess the safety and tolerability of the ACI-24 vaccine among adults with DS as well as its ability to induce immunogenicity measured by anti-Aβ immunoglobulin G titers.
Design, Setting, and Participants


This multicenter double-blind placebo-controlled dose-escalation phase 1b randomized clinical trial was conducted at 3 US academic medical centers with affiliated Down syndrome clinics between March 30, 2016, and June 29, 2020. A total of 20 adults with DS were screened; of those, 16 adults were eligible to participate. Eligibility criteria included men or women aged 25 to 45 years with cytogenetic diagnosis of either trisomy 21 or complete unbalanced translocation of chromosome 21. Between April 27, 2016, and July 2, 2018, participants were randomized 3:1 into 2 dose-level cohorts (8 participants per cohort, with 6 participants receiving the ACI-24 vaccine and 2 receiving placebo) in a 96-week study. Participants received 48 weeks of treatment followed by an additional 48 weeks of safety follow-up.
Interventions


Participants were randomized to receive 7 subcutaneous injections of ACI-24, 300 μg or 1000 μg, or placebo.
Main Outcomes and Measures


Primary outcomes were measures of safety and tolerability as well as antibody titers.
Results


Among 16 enrolled participants, the mean (SD) age was 32.6 (4.4) years; 9 participants were women, and 7 were men. All participants were White, and 1 participant had Hispanic or Latino ethnicity. Treatment adherence was 100%. There were no cases of meningoencephalitis, death, or other serious adverse events (AEs) and no withdrawals as a result of AEs. Most treatment-emergent AEs were of mild intensity (110 of 132 events [83.3%]) and unrelated or unlikely to be related to the ACI-24 vaccine (113 of 132 events [85.6%]). No amyloid-related imaging abnormalities with edema or cerebral microhemorrhage and no evidence of central nervous system inflammation were observed on magnetic resonance imaging scans. Increases in anti-Aβ immunoglobulin G titers were observed in 4 of 12 participants (33.3%) receiving ACI-24 (2 receiving 300 μg and 2 receiving 1000 μg) compared with 0 participants receiving placebo. In addition, a greater increase was observed in plasma Aβ1-40 and Aβ1-42 levels among individuals receiving ACI-24.
Conclusions and Relevance


In this study, the ACI-24 vaccine was safe and well tolerated in adults with DS. Evidence of immunogenicity along with pharmacodynamic and target engagement were observed, and anti-Aβ antibody titers were not associated with any adverse findings. These results support progression to clinical trials using an optimized formulation of the ACI-24 vaccine among individuals with DS.
Trial Registration


ClinicalTrials.gov Identifier: NCT02738450.",2022,"There were no cases of meningoencephalitis, death, or other serious adverse events (AEs) and no withdrawals as a result of AEs.","['Importance\n\n\nIndividuals with Down syndrome (DS', 'Between April 27, 2016, and July 2, 2018, participants were randomized 3:1 into 2 dose-level cohorts (8 participants per cohort, with 6 participants receiving the', 'adults with DS', 'All participants were White, and 1 participant had Hispanic or Latino ethnicity', 'Eligibility criteria included men or women aged 25 to 45 years with cytogenetic diagnosis of either trisomy 21 or complete unbalanced translocation of chromosome 21', 'individuals with DS', 'Adults With Down Syndrome', '20 adults with DS were screened; of those, 16 adults were eligible to participate', '16 enrolled participants, the mean (SD) age was 32.6 (4.4) years; 9 participants were women, and 7 were men', '3 US academic medical centers with affiliated Down syndrome clinics between March 30, 2016, and June 29, 2020']","['ACI-24 vaccine and 2 receiving placebo', 'ACI-24 vaccine', '7 subcutaneous injections of ACI-24, 300 μg or 1000 μg, or placebo', 'placebo', 'ACI-24', 'ACI-24 Vaccine']","['safe and well tolerated', 'anti-Aβ immunoglobulin G titers', 'meningoencephalitis, death, or other serious adverse events (AEs', 'safety, tolerability, and immunogenicity', 'Safety, Tolerability, and Immunogenicity', 'safety and tolerability', 'plasma Aβ1-40 and Aβ1-42 levels', 'safety and tolerability as well as antibody titers', 'mild intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2919654', 'cui_str': 'Unbalanced translocation of chromosome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3840242', 'cui_str': 'Down syndrome clinic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0540404', 'cui_str': 'adenylyl cyclase 1'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0025309', 'cui_str': 'Meningoencephalitis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",20.0,0.797082,"There were no cases of meningoencephalitis, death, or other serious adverse events (AEs) and no withdrawals as a result of AEs.","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Rafii', 'Affiliation': ""Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, San Diego, San Diego.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sol', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Mobley', 'Affiliation': 'Department of Neuroscience, University of California, San Diego, San Diego.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Delpretti', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Skotko', 'Affiliation': 'Down Syndrome Program, Division of Medical Genetics and Metabolism, Department of Pediatrics, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Anna D', 'Initials': 'AD', 'LastName': 'Burke', 'Affiliation': 'Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Marwan N', 'Initials': 'MN', 'LastName': 'Sabbagh', 'Affiliation': 'Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Shauna H', 'Initials': 'SH', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rissman', 'Affiliation': 'Department of Neuroscience, University of California, San Diego, San Diego.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pulsifer', 'Affiliation': 'Down Syndrome Program, Division of Medical Genetics and Metabolism, Department of Pediatrics, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': 'Down Syndrome Program, Division of Medical Genetics and Metabolism, Department of Pediatrics, Massachusetts General Hospital, Boston.'}, {'ForeName': 'A Carol', 'Initials': 'AC', 'LastName': 'Evans', 'Affiliation': 'Department of Neuroscience, University of California, San Diego, San Diego.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Beth', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Fournier', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Julian A', 'Initials': 'JA', 'LastName': 'Gray', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Antonio Melo', 'Initials': 'AM', 'LastName': 'Dos Santos', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Hliva', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Vukicevic', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kosco-Vilbois', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Streffer', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pfeifer', 'Affiliation': 'AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Feldman', 'Affiliation': 'Department of Neuroscience, University of California, San Diego, San Diego.'}]",JAMA neurology,['10.1001/jamaneurol.2022.0983']
1002,35532908,Efficacy and Safety of Ultrahigh-Dose Methylcobalamin in Early-Stage Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial.,"Importance


The effectiveness of currently approved drugs for amyotrophic lateral sclerosis (ALS) is restricted; there is a need to develop further treatments. Initial studies have shown ultrahigh-dose methylcobalamin to be a promising agent.
Objective


To validate the efficacy and safety of ultrahigh-dose methylcobalamin for patients with ALS enrolled within 1 year of onset.
Design, Setting, and Participants


This was a multicenter, placebo-controlled, double-blind, randomized phase 3 clinical trial with a 12-week observation and 16-week randomized period, conducted from October 17, 2017, to September 30, 2019. Patients were recruited from 25 neurology centers in Japan; those with ALS diagnosed within 1 year of onset by the updated Awaji criteria were initially enrolled. Of those, patients fulfilling the following criteria after 12-week observation were eligible for randomization: 1- or 2-point decrease in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score, a percent forced vital capacity greater than 60%, no history of noninvasive respiratory support and tracheostomy, and being ambulatory. The target participant number was 64 in both the methylcobalamin and placebo groups. Patients were randomly assigned through an electronic web-response system to methylcobalamin or placebo.
Interventions


Intramuscular injection of methylcobalamin (50-mg dose) or placebo twice weekly for 16 weeks.
Main Outcomes and Measures


The primary end point was change in ALSFRS-R total score from baseline to week 16 in the full analysis set.
Results


A total of 130 patients (mean [SD] age, 61.0 [11.7] years; 74 men [56.9%]) were randomly assigned to methylcobalamin or placebo (65 each). A total of 129 patients were eligible for the full analysis set, and 126 completed the double-blind stage. Of these, 124 patients proceeded to the open-label extended period. The least square means difference in ALSFRS-R total score at week 16 of the randomized period was 1.97 points greater with methylcobalamin than placebo (-2.66 vs -4.63; 95% CI, 0.44-3.50; P = .01). The incidence of adverse events was similar between the 2 groups.
Conclusions and Relevance


Results of this randomized clinical trial showed that ultrahigh-dose methylcobalamin was efficacious in slowing functional decline in patients with early-stage ALS and with moderate progression rate and was safe to use during the 16-week treatment period.
Trial Registration


ClinicalTrials.gov Identifier: NCT03548311.",2022,"1- or 2-point decrease in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score,","['amyotrophic lateral sclerosis (ALS', '130 patients (mean [SD] age', '129 patients were eligible for the full analysis set, and 126 completed the double-blind stage', 'Early-Stage Amyotrophic Lateral Sclerosis', '124 patients proceeded to the open-label extended period', 'patients fulfilling the following criteria after 12-week observation were eligible for randomization', 'patients with ALS enrolled within 1 year of onset', 'Patients were recruited from 25 neurology centers in Japan; those with ALS diagnosed within 1 year of onset by the updated Awaji criteria were initially enrolled', 'patients with early-stage ALS', 'conducted from October 17, 2017, to September 30, 2019', '61.0\u2009[11.7] years; 74 men [56.9']","['methylcobalamin or placebo', 'ultrahigh-dose methylcobalamin', 'methylcobalamin and placebo', 'Ultrahigh-Dose Methylcobalamin', 'methylcobalamin', 'placebo', 'electronic web-response system to methylcobalamin or placebo']","['incidence of adverse events', 'Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score', 'ALSFRS-R total score', 'efficacy and safety', 'change in ALSFRS-R total score', 'Efficacy and Safety']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",129.0,0.564388,"1- or 2-point decrease in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score,","[{'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Oki', 'Affiliation': 'Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Yuishin', 'Initials': 'Y', 'LastName': 'Izumi', 'Affiliation': 'Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nodera', 'Affiliation': 'Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Sakaguchi', 'Affiliation': 'Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nokihara', 'Affiliation': 'Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Kanai', 'Affiliation': 'Department of Neurology, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Tsunemi', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Hatanaka', 'Affiliation': 'Department of Neurology, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sonoo', 'Affiliation': 'Department of Neurology, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Atsuta', 'Affiliation': 'Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Sobue', 'Affiliation': 'Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Neurology, Tokyo Metropolitan Neurological Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazumoto', 'Initials': 'K', 'LastName': 'Shibuya', 'Affiliation': 'Department of Neurology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ikeda', 'Affiliation': 'Department of Neurology, Toho University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kano', 'Affiliation': 'Department of Neurology, Toho University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Nishinaka', 'Affiliation': 'Department of Neurology, Sumitomo Hospital, Osaka, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Neurology, Takeda General Hospital, Kyoto, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Oda', 'Affiliation': 'Department of Neurology, Vihara Hananosato Hospital, Miyoshi, Japan.'}, {'ForeName': 'Kiyonobu', 'Initials': 'K', 'LastName': 'Komai', 'Affiliation': 'Department of Neurology, National Hospital Organization Iou Hospital, Kanazawa, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Neurology, Murakami Karindoh Hospital, Fukuoka, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Kohara', 'Affiliation': 'Department of Neurology, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Urushitani', 'Affiliation': 'Department of Neurology, Shiga University of Medical Science, Otsu, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Nakayama', 'Affiliation': 'Department of Neurology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hidefumi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Neurology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Nagai', 'Affiliation': 'Department of Neurology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Nishiyama', 'Affiliation': 'Department of Neurology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kuzume', 'Affiliation': 'Department of Neurology, Chikamori Hospital, Kochi, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Shimohama', 'Affiliation': 'Department of Neurology, Sapporo Medical University, Sapporo, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Shimohata', 'Affiliation': 'Department of Neurology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Ishihara', 'Affiliation': 'Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Onodera', 'Affiliation': 'Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan.'}, {'ForeName': 'Sagiri', 'Initials': 'S', 'LastName': 'Isose', 'Affiliation': 'Department of Neurology, National Hospital Organization Chibahigashi Hospital, Chiba, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Araki', 'Affiliation': 'Department of Neurology, National Hospital Organization Chibahigashi Hospital, Chiba, Japan.'}, {'ForeName': 'Mitsuya', 'Initials': 'M', 'LastName': 'Morita', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Noda', 'Affiliation': 'Department of Neurology, Juntendo University Shizuoka Hospital, Izunokuni, Japan.'}, {'ForeName': 'Tatsushi', 'Initials': 'T', 'LastName': 'Toda', 'Affiliation': 'Department of Neurology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Furuya', 'Affiliation': 'Department of Neurology, Kochi Medical School, Kochi University, Nankoku, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Teramukai', 'Affiliation': 'Department of Biostatistics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Kagimura', 'Affiliation': 'Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation, Kobe, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Noma', 'Affiliation': 'Division of Regeneration and Medicine, Medical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yanagawa', 'Affiliation': 'Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Neurology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Kaji', 'Affiliation': 'Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2022.0901']
1003,35537372,"Effects of two types of exercise training on psychological well-being, sleep and physical fitness in patients with high-grade glioma (WHO III and IV).","BACKGROUND


There is evidence that regular exercise training has the potential to improve psychological well-being among cancer survivors. However, limited findings are available for individuals with high-grade glioma (HGG; WHO grade III and IV) after neurosurgery and undergoing radiochemotherapy. Given this, endurance and strengths training were employed to investigate their impact on symptoms of depression, feelings of stress and anxiety, fatigue, insomnia, and physical fitness, compared to an active control condition.
METHODS


A total of 29 patients (M = 52.07, SD = 12.45, 55.2% women) participated in this randomized controlled trial (RCT). After neurosurgical treatment and during adjuvant radiotherapy and chemotherapy or combined radiochemotherapy, patients were randomly assigned to the following conditions: Endurance training (n = 10); strengths training (n = 11); active control condition (n = 8). At baseline, three weeks and six weeks later at the end of the study physical fitness was objectively measured with a 6-min walk test (6MWT) and a handgrip test. Participants completed a series of questionnaires covering sociodemographic information, symptoms of depression, stress, anxiety, fatigue, and insomnia. Further, experts rated participants' severity of symptoms of depression.
RESULTS


Over time and compared to the strengths and active control condition, self-rated symptoms of depression, state and trait anxiety, stress and insomnia decreased in the endurance condition. Over time and compared to the endurance and active control condition, no changes on symptoms of depression, anxiety, stress, or insomnia were observed in the strengths condition. Over time and compared to the endurance and strengths condition, symptoms of depression (self-ratings), stress, insomnia and fatigue decreased in the active control condition. Fatigue increased in both exercising conditions. Over time and irrespective from the study condition, physical fitness did neither improve nor decrease.
CONCLUSIONS


The pattern of results suggests that endurance training and an active control condition improved dimensions of depression, stress, and anxiety, while mere strengths training appeared to neither improve, nor decrease dimensions of psychological functioning. Further, exercise interventions did not change physical fitness, but increased fatigue. Overall, endurance training and an active control condition appeared to favorably impact on psychological well-being among patients with high-grade glioma after neurosurgery and undergoing radiochemotherapy.",2022,"Over time and compared to the endurance and active control condition, no changes on symptoms of depression, anxiety, stress, or insomnia were observed in the strengths condition.","['29 patients (M\xa0=\xa052.07, SD\xa0=\xa012.45, 55.2% women', 'patients with high-grade glioma after neurosurgery and undergoing', 'patients with high-grade glioma (WHO III and IV', 'individuals with high-grade glioma (HGG; WHO grade III and IV) after neurosurgery and undergoing']","['adjuvant radiotherapy and chemotherapy or combined radiochemotherapy', 'regular exercise training', 'exercise training', 'radiochemotherapy', 'endurance training', 'Endurance training (n\xa0=\xa010); strengths training (n\xa0=\xa011); active control condition']","['fatigue', 'endurance and strengths condition, symptoms of depression (self-ratings), stress, insomnia and fatigue', 'psychological well-being, sleep and physical fitness', 'symptoms of depression, anxiety, stress, or insomnia', 'Fatigue', 'strengths and active control condition, self-rated symptoms of depression, state and trait anxiety, stress and insomnia', 'questionnaires covering sociodemographic information, symptoms of depression, stress, anxiety, fatigue, and insomnia', 'dimensions of depression, stress, and anxiety', 'change physical fitness', '6-min walk test (6MWT) and a handgrip test', 'symptoms of depression, feelings of stress and anxiety, fatigue, insomnia, and physical fitness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",29.0,0.0155296,"Over time and compared to the endurance and active control condition, no changes on symptoms of depression, anxiety, stress, or insomnia were observed in the strengths condition.","[{'ForeName': 'Larina', 'Initials': 'L', 'LastName': 'Eisenhut', 'Affiliation': 'University of Basel, Department of Neurosurgery, Basel, Switzerland; University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Center for Affective, Stress and Sleep Disorders (ZASS), Psychiatric University Hospital Basel, 4002, Basel, Switzerland.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi-Bahmani', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland.'}, {'ForeName': 'Attill', 'Initials': 'A', 'LastName': 'Saemann', 'Affiliation': 'University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland.'}, {'ForeName': 'Laurin', 'Initials': 'L', 'LastName': 'Staub', 'Affiliation': 'University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Center for Affective, Stress and Sleep Disorders (ZASS), Psychiatric University Hospital Basel, 4002, Basel, Switzerland; Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, 67146, Iran; Substance Abuse Prevention Research Center, Health, Institute, Kermanshah University of Medical Sciences, Kermanshah, 67146, Iran; School of Medicine, Tehran University of Medical Sciences, Tehran, 25529, Iran.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Cordier', 'Affiliation': 'University of Basel, Department of Neurosurgery, Basel, Switzerland. Electronic address: dominik.cordier@usb.ch.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.03.058']
1004,35545237,The effect of time management education on critical care nurses' prioritization: a randomized clinical trial.,"BACKGROUND


Nurses are at the forefront of patient care, and time management skills can increase their ability to make decisions faster. This study aimed to assess the effect of a time management workshop on prioritization and time management skills among nurses of emergency and intensive care units.
METHODS


This randomized clinical trial was performed with 215 nurses. The educational intervention about time management was held in the form of a workshop for the intervention group. The time management questionnaire was completed by both groups before, immediately after, and 3 months after the intervention.
RESULTS


Most participants were female (n=191, 88%), with a mean age of 31.82 years (range, 22-63 years). Additionally, the participants' work experience ranged from 1 to 30 years (mean±standard deviation, 8.00±7.15 years). After the intervention, the mean score of time management increased significantly in the intervention group, but no significant difference was observed in this regard in the control group. The results also revealed a significant difference between the intervention and control groups regarding the mean score of time management 3 months after the intervention (P<0.001).
CONCLUSIONS


Time management training helped nurses adjust the time required to perform and prioritize various tasks.",2022,"After the intervention, the mean score of time management increased significantly in the intervention group, but no significant difference was observed in this regard in the control group.","['nurses of emergency and intensive care units', 'participants were female (n=191, 88%), with a mean age of 31.82 years (range, 22-63 years', '215 nurses', ""critical care nurses' prioritization""]","['time management workshop', 'time management education']","['time management questionnaire', 'time required to perform and prioritize various tasks', 'mean score of time management']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",215.0,0.0132693,"After the intervention, the mean score of time management increased significantly in the intervention group, but no significant difference was observed in this regard in the control group.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Vizeshfar', 'Affiliation': 'Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Rakhshan', 'Affiliation': 'Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shirazi', 'Affiliation': 'Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Dokoohaki', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Acute and critical care,['10.4266/acc.2021.01123']
1005,35550854,Mindfulness-based stress reduction increases stimulated IL-6 production among lonely older adults: A randomized controlled trial.,"Loneliness is a potent psychosocial stressor that predicts poor health and mortality among older adults, possibly in part by accelerating age-related declines in immunocompetence. Mindfulness interventions have shown promise for reducing loneliness and improving markers of physical health. In a sample of lonely older adults, this two-arm parallel trial tested whether mindfulness training enhances stimulated interleukin-6 (IL-6) production, a measure of innate immune responsivity. Lonely older adults (65-85 years; N = 190) were randomized to an 8-week Mindfulness-Based Stress Reduction (MBSR) or control Health Enhancement Program (HEP) intervention. Lipopolysaccharide (LPS)-stimulated production of IL-6 was measured in vitro by blinded outcome assessors at pre-intervention, post-intervention, and 3-month follow-up. Mixed-effects linear models tested time (pre, post, follow-up) by condition (MBSR vs. HEP) effects. As predicted, a significant time × condition effect on stimulated IL-6 production was observed across pre, post, and follow-up timepoints. Significant MBSR vs. HEP differences emerged from pre- to post-intervention (p =.009, d = 0.38) and from pre-intervention to 3-month follow-up (p =.017, d = 0.35), with larger increases in IL-6 production following MBSR compared to HEP. No study-related adverse events were reported. Results show that mindfulness training may be effective for boosting innate immunocompetence among lonely older adults. Given that immunocompetence tends to decline with age, mindfulness training may help to counteract the effects of aging and psychosocial stress on infection risk and recovery from injury.",2022,"Significant MBSR vs. HEP differences emerged from pre- to post-intervention (p=.009, d=.38) and from pre-intervention to 3-month follow-up (p=.017, d=.35), with larger increases in IL-6 production following MBSR compared to HEP.","['lonely older adults', 'Lonely older adults (65-85 years; N=190', 'older adults']","['8-week Mindfulness-Based Stress Reduction (MBSR) or control Health Enhancement Program (HEP) intervention', 'mindfulness training', 'Mindfulness-Based Stress Reduction']","['stimulated IL-6 production', 'IL-6 production', 'interleukin-6 (IL-6) production', 'Lipopolysaccharide (LPS)-stimulated production of IL-6']","[{'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",190.0,0.0358924,"Significant MBSR vs. HEP differences emerged from pre- to post-intervention (p=.009, d=.38) and from pre-intervention to 3-month follow-up (p=.017, d=.35), with larger increases in IL-6 production following MBSR compared to HEP.","[{'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Lindsay', 'Affiliation': 'University of Pittsburgh, United States. Electronic address: emily.lindsay@pitt.edu.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Creswell', 'Affiliation': 'Carnegie Mellon University, United States.'}, {'ForeName': 'Harrison J', 'Initials': 'HJ', 'LastName': 'Stern', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Greco', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Walko', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Dutcher', 'Affiliation': 'Carnegie Mellon University, United States.'}, {'ForeName': 'Aidan G C', 'Initials': 'AGC', 'LastName': 'Wright', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Kirk Warren', 'Initials': 'KW', 'LastName': 'Brown', 'Affiliation': 'Virginia Commonwealth University, United States.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Marsland', 'Affiliation': 'University of Pittsburgh, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2022.05.001']
1006,35550819,Comparison of Dabigatran Versus Warfarin Treatment for Prevention of New Cerebral Lesions in Valvular Atrial Fibrillation.,"Warfarin is the standard anticoagulation therapy for valvular atrial fibrillation (AF); however, new oral anticoagulants have emerged as an alternative. We compared the efficacy and safety of dabigatran with conventional treatment in AF associated with left-sided valvular heart disease (VHD), including mitral stenosis (MS). Patients with AF and left-sided VHD were randomly assigned to receive dabigatran or conventional treatment. The primary end point was the occurrence of clinical stroke or a new brain lesion (silent brain infarct and microbleed) on 1-year follow-up brain magnetic resonance imaging. Patients in the dabigatran group were switched from warfarin (n = 52), antiplatelets alone (n = 5), or no therapy (n = 2) to dabigatran. In the conventional group, 53 used warfarin (including 42 MS patients), and 7 used antiplatelets. No death or clinical stroke event occurred in either group during follow-up. Silent brain infarct and microbleed occurred in 20 and 2 patients in the dabigatran group and 20 and 4 patients in the conventional treatment group. The incidence rate of the primary end point did not significantly differ between groups (34% vs 40%, relative risk 0.87, 95% confidence interval 0.59 to 1.29, p = 0.491). The primary end point rate was similar between groups in 82 patients (40 in the dabigatran group and 42 in the conventional group) with MS (32% vs 34%, relative risk 0.93, 95% confidence interval: 0.57 to 1.50, p = 0.759). In conclusion, primary end point rates after treatment with dabigatran were similar to conventional treatment in patients with significant VHD and AF. New oral anticoagulants could be a reasonable alternative to warfarin in patients with AF and VHD, which should be confirmed in future large-scale studies.",2022,"The incidence rate of the primary end point did not significantly differ between groups (34% vs 40%, relative risk 0.87, 95% confidence interval 0.59 to 1.29, p = 0.491).","['Valvular Atrial Fibrillation', 'valvular atrial fibrillation (AF', 'Patients with AF and left-sided VHD', 'AF associated with left-sided valvular heart disease (VHD), including mitral stenosis (MS', 'patients with AF and VHD']","['Warfarin', 'warfarin', 'dabigatran', 'dabigatran or conventional treatment', 'Dabigatran Versus Warfarin', 'antiplatelets alone (n\xa0=\xa05), or no therapy (n\xa0=\xa02) to dabigatran']","['Silent brain infarct and microbleed', 'incidence rate', 'occurrence of clinical stroke or a new brain lesion (silent brain infarct and microbleed) on 1-year follow-up brain magnetic resonance imaging', 'efficacy and safety', 'death or clinical stroke event']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018824', 'cui_str': 'Heart valve disorder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026269', 'cui_str': 'Mitral valve stenosis'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0751955', 'cui_str': 'Brain Infarct'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0603359,"The incidence rate of the primary end point did not significantly differ between groups (34% vs 40%, relative risk 0.87, 95% confidence interval 0.59 to 1.29, p = 0.491).","[{'ForeName': 'Min Soo', 'Initials': 'MS', 'LastName': 'Cho', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Minsu', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, School of Medicine, Chungnam National University, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Seung-Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sahmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dae-Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong-Min', 'Initials': 'JM', 'LastName': 'Song', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Gi-Byoung', 'Initials': 'GB', 'LastName': 'Nam', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Duk-Hyun', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Electronic address: dhkang@amc.seoul.kr.'}, {'ForeName': 'Kee-Joon', 'Initials': 'KJ', 'LastName': 'Choi', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Electronic address: kjchoi@amc.seoul.kr.'}]",The American journal of cardiology,['10.1016/j.amjcard.2022.03.050']
1007,35533885,Economic analysis of financial incentives for smoking cessation during pregnancy and postpartum.,"Higgins and colleagues' recently-completed randomized controlled trial and pooled data with 4 related trials of smoking cessation in pregnant women in Vermont (USA) showed that abstinence-contingent financial incentives (FI) increased abstinence over control conditions from early pregnancy through 24-weeks postpartum. Control conditions were best practices (BP) alone in the recent trial and payments provided independent of smoking status (noncontingently) in the others. This paper reports economic analyses of abstinence-contingent FI. Merging trial results with maternal and infant healthcare costs from all Vermont Medicaid deliveries in 2019, we computed incremental cost-effectiveness ratios (ICERs) for quality-adjusted life years (QALYs) and compared them to established thresholds. The healthcare sector cost (±standard error) of adding FI to BP averaged $634.76 ± $531.61 per participant. Based on this trial, the increased probability per BP + FI participant of smoking abstinence at 24-weeks postpartum was 3.17%, the cost per additional abstinent woman was $20,043, the incremental health gain was 0.0270 ± 0.0412 QALYs, the ICER was $23,511/QALY gained, and the probabilities that BP + FI was very cost-effective (ICER≤$65,910) and cost-effective (ICER≤$100,000) were 67.9% and 71.0%, respectively. Based on the pooled trials, the corresponding values were even more favorable-8.89%, $7138, 0.0758 ± 0.0178 QALYs, $8371/QALY, 98.6% and 99.3%, respectively. Each dollar invested in abstinence-contingent FI over control smoking-cessation programs yielded $4.20 in economic benefits in the recent trial and $11.90 in the pooled trials (very favorable benefit-cost ratios). Medicaid and commercial insurers may wish to consider covering financial incentives for smoking abstinence as a cost-effective service for pregnant beneficiaries who smoke. Trial Registration: ClinicalTrials.gov identifier: NCT02210832.",2022,The healthcare sector cost (±standard error) of adding FI to BP averaged $634.76 ± $531.61 per participant.,"['pregnant women in Vermont (USA', 'pregnant beneficiaries who smoke']",['abstinence-contingent financial incentives (FI'],"['incremental cost-effectiveness ratios (ICERs) for quality-adjusted life years (QALYs', 'healthcare sector cost (±standard error) of adding FI to BP', 'incremental health gain', 'cost-effective (ICER≤$65,910) and cost-effective (ICER≤$100,000', 'probability per BP\u202f+\u202fFI participant of smoking abstinence']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0042537', 'cui_str': 'Vermont'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0525053', 'cui_str': 'Healthcare Sector'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.187469,The healthcare sector cost (±standard error) of adding FI to BP averaged $634.76 ± $531.61 per participant.,"[{'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Shepard', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, USA; Heller School for Social Poilcy and Management, MS 035, Brandeis University, Waltham, MA 02454-9110 USA. Electronic address: shepard@brandeis.edu.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Slade', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, USA; Johns Hopkins University School of Nursing, USA.'}, {'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Nighbor', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'DeSarno', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, USA; Department of Medical Biostatistics, University of Vermont, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Roemhildt', 'Affiliation': 'Vermont Department of Health, USA.'}, {'ForeName': 'Rhonda K', 'Initials': 'RK', 'LastName': 'Williams', 'Affiliation': 'Vermont Department of Health, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2022.107079']
1008,35533876,"Harvest for Health, a Randomized Controlled Trial Testing a Home-Based, Vegetable Gardening Intervention Among Older Cancer Survivors Across Alabama: An Analysis of Accrual and Modifications Made in Intervention Delivery and Assessment During COVID-19.","BACKGROUND


Accelerated functional decline is a concern among older cancer survivors that threatens independence and quality of life. Pilot studies suggest that vegetable gardening interventions ameliorate functional decline through improved diet and physical activity.
OBJECTIVE


The aim of this article was to describe the rationale, recruitment challenges, and enrollment for the Harvest for Health randomized controlled trial (RCT), which will test the impact of a home-based, vegetable gardening intervention on vegetable and fruit consumption, physical activity, and physical functioning among older cancer survivors. Modifications made to the intervention and assessments to assure safety and continuity of the RCT throughout the COVID-19 pandemic also are reported.
DESIGN


Harvest for Health is a 2-year, 2-arm, single-blinded, wait-list controlled RCT with cross-over.
PARTICIPANTS/SETTING


Medicare-eligible survivors of cancers with ≥60% 5-year survival were recruited across Alabama from October 1, 2016 to February 8, 2021.
INTERVENTION


Participants were randomly assigned to a wait-list control or a 1-year home-based gardening intervention and individually mentored by extension-certified master gardeners to cultivate spring, summer, and fall vegetable gardens.
MAIN OUTCOME MEASURES


Although the RCT's primary end point was a composite measure of vegetable and fruit consumption, physical activity, and physical functioning, this article focuses on recruitment and modifications made to the intervention and assessments during COVID-19.
STATISTICAL ANALYSES PERFORMED


χ 2  and t tests (α < .05) were used to compare enrolled vs unenrolled populations.
RESULTS


Older cancer survivors (n = 9,708) were contacted via mail and telephone; 1,460 indicated interest (15% response rate), 473 were screened eligible and consented, and 381 completed baseline assessments and were randomized. Enrollees did not differ from nonrespondents/refusals by race and ethnicity, or rural-urban status, but comprised significantly higher numbers of comparatively younger survivors, those who were female, and survivors of breast cancer (P < .001). Although COVID-19 delayed trial completion, protocol modifications overcame this barrier and study completion is anticipated by June 2022.
CONCLUSIONS


This RCT will provide evidence on the effects of a mentored vegetable gardening program among older cancer survivors. If efficacious, Harvest for Health represents a novel, multifaceted approach to improve lifestyle behaviors and health outcomes among cancer survivors-one with capacity for sustainability and widespread dissemination.",2022,"Enrollees did not differ from non-respondents/refusals by race and ethnicity, or rural-urban status, but were comprised of significantly higher numbers of comparatively younger survivors, those who were female, and survivors of breast cancer (p-values<0.001).","['older cancer survivors', 'Older cancer survivors (n=9,708) were contacted by letter and telephone; 1,460 indicated interest (15% response rate), 473 were screened eligible and consented, and 381 completed baseline assessments and were randomized', 'Older Cancer Survivors across Alabama', 'setting: Medicare-eligible survivors of cancers with >60% 5-year survival were recruited across Alabama from October 1, 2016 to February 8, 2021']","['vegetable gardening interventions', 'wait-list control or a 1-year home-based gardening intervention and individually-mentored by Extension-certified Master Gardeners to cultivate spring, summer, and fall vegetable gardens', 'Vegetable Gardening Intervention']","['vegetable & fruit (V&F) consumption, physical activity, and physical functioning', 'V&F consumption, physical activity, and physical functioning']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0335454', 'cui_str': 'Gardener'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",9708.0,0.162598,"Enrollees did not differ from non-respondents/refusals by race and ethnicity, or rural-urban status, but were comprised of significantly higher numbers of comparatively younger survivors, those who were female, and survivors of breast cancer (p-values<0.001).","[{'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Bail', 'Affiliation': 'College of Nursing, University of Alabama in Huntsville, Huntsville, AL; Department of Nutrition Sciences, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Cindy K', 'Initials': 'CK', 'LastName': 'Blair', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Kerry P', 'Initials': 'KP', 'LastName': 'Smith', 'Affiliation': 'Alabama Cooperative Extension System, Auburn University, Auburn, AL.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Oster', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Harleen', 'Initials': 'H', 'LastName': 'Kaur', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Locher', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Frugé', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL; Department of Nutrition, Dietetics & Hospitality Management, Auburn University, Auburn, AL.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Rocque', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pisu', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Harvey Jay', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL. Electronic address: demark@uab.edu.'}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2022.05.005']
1009,35537216,Modulation of dorsolateral prefrontal cortex functional connectivity after intermittent theta-burst stimulation in depression: Combining findings from fNIRS and fMRI.,"BACKGROUND


Resting-state functional magnetic resonance imaging (fMRI) can assess modulation of functional connectivity networks following repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression. Functional near-infrared spectroscopy (fNIRS) is well suited for the concurrent application during rTMS treatment sessions to capture immediate blood oxygenation (oxy-Hb) effects, however limited in spatial resolution.
OBJECTIVE


To understand the network effects behind such a prefrontal fNIRS response during rTMS, and to test whether the fNIRS signal may be predictive of treatment response, we linked data from fNIRS and fMRI within a clinical intervention study.
METHODS


42 patients with ongoing depression were recruited and randomized to receive active or sham intermittent theta-burst stimulation (iTBS) over the dorsomedial prefrontal cortex (dmPFC) twice daily for ten days at target intensity. Oxy-Hb was recorded with fNIRS during the first, fifth, and final day of iTBS, with the probe holders located laterally to the TMS coil over regions corresponding to the left and right dorsolateral prefrontal cortex (dlPFC). Resting-state fMRI scanning was performed before and after the whole iTBS treatment course. Functional connectivity analyses were then performed using dlPFC seeds from parcels of a brain atlas showing most overlap with the fNIRS probe locations during treatment.
RESULTS


After active iTBS, left dlPFC-connectivity to the right insula/operculum was reduced compared to sham. The left insula showed a connectivity reduction to the left dlPFC that correlated with an improvement in symptoms. In addition, the posterior parietal cortex showed a connectivity reduction to the left dlPFC that correlated with the fNIRS signal following active iTBS. Finally, the fNIRS oxy-Hb signal from the left dlPFC-seed during the first treatment day was predictive of dlPFC-connectivity change to precentral and temporal cortex regions.
CONCLUSION


By linking findings from these two different methods, this study suggests that changes within both the salience network and the central executive network affect the fNIRS response to iTBS.",2022,"After active iTBS, left dlPFC-connectivity to the right insula/operculum was reduced compared to sham.","['depression', '42 patients with ongoing depression']","['repetitive transcranial magnetic stimulation (rTMS', 'Functional near-infrared spectroscopy (fNIRS', 'Resting-state functional magnetic resonance imaging (fMRI', 'active or sham intermittent theta-burst stimulation (iTBS) over the dorsomedial prefrontal cortex (dmPFC']",['left dlPFC-connectivity to the right insula/operculum'],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0546911', 'cui_str': 'To the right'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0228262', 'cui_str': 'Operculum structure'}]",42.0,0.0554162,"After active iTBS, left dlPFC-connectivity to the right insula/operculum was reduced compared to sham.","[{'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Struckmann', 'Affiliation': 'Department of Medical Sciences, Psychiatry, Uppsala University, Sweden. Electronic address: wiebke.struckmann@neuro.uu.se.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bodén', 'Affiliation': 'Department of Medical Sciences, Psychiatry, Uppsala University, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Gingnell', 'Affiliation': 'Department of Medical Sciences, Psychiatry, Uppsala University, Sweden; Department of Psychology, Uppsala University, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fällmar', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Department of Medical Sciences, Psychiatry, Uppsala University, Sweden.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2022.103028']
1010,35538523,Examination of influence of social media education through mobile phones on the change in physical activity and sedentary behavior in pregnant women: a randomized controlled trial.,"BACKGROUND


Nowadays because of some necessities and demands for virtual and remote education, a new model of health approach through mobile-phones is widely used to deal with improving physical activity and its beneficial effect on pregnancy. There are a small number of studies for showing this importance and the efficacy of such methods, so this study was aimed to determine the influence of social networking through mobile phones on changing the physical activity behavior in pregnant women.
METHODS


This randomized controlled trial was conducted with parallel groups on 90 pregnant women referring to Urmia health centers in 2018-2019. The participants from various social and economic backgrounds were included. The participants were randomly assigned to a control and a treatment group. Demographic and Pregnancy Physical Activity Questionnaire (PPAQ) questionnaires were filled. In addition to routine cares, the treatment group received educational intervention through social network within 16 training sessions related to physical activity and nutrition in 8 weeks.
RESULTS


The mean weight in both control and treatment groups changed significantly during the study, but in different trends (P < 0.001, Mean Difference (MD) = 4.43). At the beginning of the study, control and treatment groups were not different in terms of daily physical activity level (P = 0.17, MD = 0.62), meanwhile, there was a statistically significant difference at the end of intervention in the level of daily physical activity (P < 0.001, MD = 0.69). Comparison of both groups, based on different categories of activity level at the end of the treatment, showed a non-significant difference in sedentary activities (P = 0.89, MD = 0.46), but the intervention led to a significant difference based on the other level of activities; light (P < 0.001, MD = 51.94), moderate (P < 0.001, MD = 46.87), and sever (P = 0.05, MD = 1.07).
CONCLUSION


Educational intervention based on social networks through mobile phones had an effective role in behavior change in physical activity during pregnancy.
TRIAL REGISTRATION


IRCT20151004024340N15, Registration date05/06/2020.",2022,"The mean weight in both control and treatment groups changed significantly during the study, but in different trends (P < 0.001, Mean Difference (MD) = 4.43).","['90 pregnant women referring to Urmia health centers in 2018-2019', 'pregnant women']","['educational intervention', 'Educational intervention', 'social media education through mobile phones']","['physical activity and sedentary behavior', 'sedentary activities', 'daily physical activity level', 'activity level', 'level of activities; light', 'mean weight', 'level of daily physical activity', 'Demographic and Pregnancy Physical Activity Questionnaire (PPAQ) questionnaires']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",90.0,0.0292402,"The mean weight in both control and treatment groups changed significantly during the study, but in different trends (P < 0.001, Mean Difference (MD) = 4.43).","[{'ForeName': 'Erfaneh', 'Initials': 'E', 'LastName': 'Talebi', 'Affiliation': 'Student Research Committee, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Mohaddesi', 'Affiliation': 'Non Communicable Disease Research Center, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Davoud', 'Initials': 'D', 'LastName': 'Vahabzadeh', 'Affiliation': 'Non Communicable Disease Research Center, Ilam University of Medical Sciences, Ilam, Iran. dvaha2003@yahoo.com.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Rasuli', 'Affiliation': 'Maternal and Childhood Obesity Research Center, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}]",BMC women's health,['10.1186/s12905-022-01725-x']
1011,35538479,Randomized study on the effectiveness of nomegestrol acetate plus 17β-estradiol oral contraceptive versus dienogest oral pill in women with suspected endometriosis‑associated chronic pelvic pain.,"BACKGROUND


To evaluate the effects of a combined oral contraceptive containing 1.5 mg 17b-estradiol (E2) and 2.5 mg nomegestrol acetate (NOMAC) or 2 mg/daily dienogest (DNG) oral progestin on endometriosis-associated chronic pelvic pain (CPP) and on the quality of life (QoL) and sexual function, by a randomized study design.
METHODS


The E2/NOMAC group and DNG group included 99 and 98 women, respectively. The levels of CPP were measured by the visual analogic scale (VAS). The QoL scores were investigated by the Short Form-36 questionnaire (SF-36). Finally, sexual function was studied using the Female Sexual Function Index (FSFI), while sexual distress was studied by the Female Sexual Distress Scale (FSDS). The study had 3, 6 and 12-month follow-ups.
RESULTS


The intra-group analysis showed an improvement of the VAS score from baseline to the 12-month follow-up in the women of both groups (p < 0.001). The inter-group comparison showed a similar improvement of CPP (p = 0.06). Women on DNG had better SF-36 somatic (p < 0.01) and FSFI scores (p < 0.006) than women on E2/NOMAC at the 6- and 12-month follow-ups.
CONCLUSIONS


The results support the efficacy of both hormonal treatments, even if DNG was more effective than E2/NOMAC in a limited intergroup comparison.",2022,"Women on DNG had better SF-36 somatic (p < 0.01) and FSFI scores (p < 0.006) than women on E2/NOMAC at the 6- and 12-month follow-ups.
",['women with suspected endometriosis‑associated chronic pelvic pain'],"['E2/NOMAC', 'nomegestrol acetate plus 17β-estradiol oral contraceptive versus dienogest oral pill', 'combined oral contraceptive containing 1.5\xa0mg 17b-estradiol (E2) and 2.5\xa0mg nomegestrol acetate (NOMAC) or 2\xa0mg/daily dienogest (DNG) oral progestin']","['QoL scores', 'endometriosis-associated chronic pelvic pain (CPP', 'Female Sexual Function Index (FSFI), while sexual distress', 'CPP', 'Female Sexual Distress Scale (FSDS', 'levels of CPP', 'SF-36 somatic', 'VAS score', 'FSFI scores', 'quality of life (QoL) and sexual function', 'Short Form-36 questionnaire (SF-36', 'visual analogic scale (VAS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0132749', 'cui_str': 'Nomegestrol acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",,0.0169049,"Women on DNG had better SF-36 somatic (p < 0.01) and FSFI scores (p < 0.006) than women on E2/NOMAC at the 6- and 12-month follow-ups.
","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Department of General Surgery and Medical Surgical Specialties, Gynecological Clinic, University of Catania, Via Santa Sofia 78, 95123, Catania, Italy. scaruso@unict.it.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cianci', 'Affiliation': 'Department of General Surgery and Medical Surgical Specialties, Gynecological Clinic, University of Catania, Via Santa Sofia 78, 95123, Catania, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Iraci Sareri', 'Affiliation': 'Department of General Surgery and Medical Surgical Specialties, Gynecological Clinic, University of Catania, Via Santa Sofia 78, 95123, Catania, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Panella', 'Affiliation': 'Department of General Surgery and Medical Surgical Specialties, Gynecological Clinic, University of Catania, Via Santa Sofia 78, 95123, Catania, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Caruso', 'Affiliation': 'Department BIOMETEC, University of Catania, Catania, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cianci', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Messina, Messina, Italy.'}]",BMC women's health,['10.1186/s12905-022-01737-7']
1012,35545356,Mindfulness-based intervention in patients with persistent pain in chest (MIPIC) of non-cardiac cause: a feasibility randomised control study.,"OBJECTIVE


The study evaluated the feasibility of mindfulness-based cognitive therapy (MBCT) in patients with non-cardiac chest pain by assessing their willingness to participate and adhere to the programme, and for these data to help further refine the content of MBCT for chest pain.
PATIENTS AND METHODS


This prospective 2:1 randomised controlled trial compared the intervention of adapted MBCT as an addition to usual care with just usual care in controls. Among 573 patients who attended the rapid access chest pain clinic over the previous 12 months and were not diagnosed with a cardiac cause but had persistent chest pain were invited. The intervention was a 2-hour, weekly, online guided 8-week MBCT course. Compliance with attendance and the home practice was recorded. Enrolled patients completed the Seattle angina questionnaire (SAQ), Hospital Anxiety and Depression Scale, Cardiac Anxiety Questionnaire, Five-Facet Mindfulness Questionnaire, and Euro Quality of Life-5 Dimensions-5 Level at baseline assessment and after 8-week period.
RESULTS


Persistent chest pain was reported by 114 patients. Of these, 33 (29%) patients with a mean age of 54.2 (±12.2) years and 68% women, consented to the study. Baseline questionnaires revealed mild physical limitation (mean SAQ, 76.8±25), high levels of anxiety (76%) and depression (53%), modest cardiac anxiety (CAQ,1.78±0.61) and mindfulness score (FFMQ, 45.5±7.3). Six patients subsequently withdrew due to bereavement, caring responsibilities and ill health. Of the remaining 27 participants, 18 in the intervention arm attended an average of 5 sessions with 61% attending ≥6 sessions. Although not statistically powered, the study revealed a significant reduction in general anxiety, improved mindfulness and a trend towards improvement in SAQ scores in the intervention arm.
CONCLUSION


One-third of patients with persistent non-cardiac chest pain were willing to participate in mindfulness-based therapy. An improvement in anxiety and mindfulness was detected in this feasibility study. A larger trial is required to demonstrate improvement in chest pain symptoms.",2022,"Although not statistically powered, the study revealed a significant reduction in general anxiety, improved mindfulness and a trend towards improvement in SAQ scores in the intervention arm.
","['Six patients subsequently withdrew due to bereavement, caring responsibilities and ill health', 'patients with persistent pain in chest (MIPIC) of non-cardiac cause', 'usual care with just usual care in controls', 'patients with non-cardiac chest pain', '33 (29%) patients with a mean age of 54.2 (±12.2) years and 68% women, consented to the study', '573 patients who attended the rapid access chest pain clinic over the previous 12 months and were not diagnosed with a cardiac cause but had persistent chest pain were invited']","['Mindfulness-based intervention', 'adapted MBCT', 'mindfulness-based cognitive therapy (MBCT']","['SAQ scores', 'mild physical limitation (mean SAQ, 76.8±25), high levels of anxiety', 'modest cardiac anxiety', 'anxiety and mindfulness', 'chest pain', 'Seattle angina questionnaire (SAQ), Hospital Anxiety and Depression Scale, Cardiac Anxiety Questionnaire, Five-Facet Mindfulness Questionnaire, and Euro Quality of Life-5 Dimensions-5 Level', 'general anxiety, improved mindfulness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005119', 'cui_str': 'Bereavement'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",573.0,0.014372,"Although not statistically powered, the study revealed a significant reduction in general anxiety, improved mindfulness and a trend towards improvement in SAQ scores in the intervention arm.
","[{'ForeName': 'Tarun Kumar', 'Initials': 'TK', 'LastName': 'Mittal', 'Affiliation': ""Heart Division, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, London, UK t.mittal@outlook.com.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'Oxford Psychological Medicine Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Pottle', 'Affiliation': ""Heart Division, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Costas', 'Initials': 'C', 'LastName': 'Lambropoulos', 'Affiliation': 'Paron Mindfulness, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Morris', 'Affiliation': 'Paron Mindfulness, London, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Surawy', 'Affiliation': 'Oxford Mindfulness Centre, Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Chuter', 'Affiliation': ""Heart Division, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cox', 'Affiliation': ""Heart Division, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ranil', 'Initials': 'R', 'LastName': 'de Silva', 'Affiliation': ""Heart Division, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': ""Heart Division, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'Department of Medical Statistics, Research & Development, Royal Brompton and Harefield Hospitals, London, UK.'}, {'ForeName': 'Diviash', 'Initials': 'D', 'LastName': 'Thakrar', 'Affiliation': 'Acre Surgery, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tyrer', 'Affiliation': 'Centre of Psychiatry, Imperial College London, London, UK.'}]",Open heart,['10.1136/openhrt-2022-001970']
1013,34936232,"Are nonsteroidal anti-inflammatory drugs effective enough for postoperative pain control after functional endoscopic sinus surgery and septoplasty? A randomized, controlled study.","BACKGROUND


Endoscopic sinus surgery (ESS) and septoplasty are commonly performed procedures without standardized postoperative pain regimens. There is reluctance to prescribe opioids for postoperative pain given their potential for abuse. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been demonstrated to reduce or even obviate the need for opioid pain medications after otolaryngologic surgeries, but prospective validation is lacking.
METHODS


A randomized, controlled study comparing the efficacy of diclofenac sodium to hydrocodone/acetaminophen (APAP) after ESS with or without septoplasty was performed. Participants were given a 100-mm visual analog pain scale (VAS) at postoperative days (PODs) 1, 2, 3, and 5 after ESS. Two-sample t tests were used to compare pain scores between groups.
RESULTS


One hundred patients enrolled, and 74 patients provided pain scores to the survey. Pain was greatest for both groups on POD 1. Treatment with diclofenac sodium vs hydrocodone/APAP did not statistically impact pain scores at PODs 1, 2, 3, or 5. No cases of epistaxis requiring an emergency room visit or return to the operating room were noted during the study period.
CONCLUSION


Diclofenac sodium may be non-inferior to hydrocodone/APAP in treating pain after ESS with or without septoplasty in opioid naive patients without pre-existing pain conditions. Further studies with larger samples are warranted to investigate the potential superiority of diclofenac to hydrocodone/APAP in certain patients after ESS and septoplasty.",2022,"Treatment with diclofenac sodium vs hydrocodone/APAP did not statistically impact pain scores at PODs 1, 2, 3, or 5.","['One hundred patients enrolled, and 74 patients provided']","['diclofenac', 'diclofenac sodium to hydrocodone/acetaminophen (APAP', 'hydrocodone/APAP', 'Endoscopic sinus surgery (ESS) and septoplasty', 'Diclofenac sodium', 'diclofenac sodium vs hydrocodone/APAP', 'Nonsteroidal anti-inflammatory drugs (NSAIDs']","['100-mm visual analog pain scale (VAS', 'Pain', 'pain scores', 'impact pain scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0717367', 'cui_str': 'Acetaminophen- and hydrocodone-containing product'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",100.0,0.0608165,"Treatment with diclofenac sodium vs hydrocodone/APAP did not statistically impact pain scores at PODs 1, 2, 3, or 5.","[{'ForeName': 'Alok T', 'Initials': 'AT', 'LastName': 'Saini', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Zi Y', 'Initials': 'ZY', 'LastName': 'Jiang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': 'Starr', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Talmadge', 'Affiliation': 'Department of Otolaryngology and Communicative Sciences, Medical College of Wisconsin, Kenosha, WI.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Schmale', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Radabaugh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Yao', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Amber U', 'Initials': 'AU', 'LastName': 'Luong', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Citardi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}]",International forum of allergy & rhinology,['10.1002/alr.22941']
1014,35024908,Effects of a training program for occupational health professionals on the cognitions and perceptions of workers: a randomized controlled trial.,"PURPOSE


To evaluate the effects of a training program for occupational health professionals (OHPs) on their ability to identify the cognitions and perceptions of workers with a chronic disease that may hinder work participation, and on their ability to recommend evidence-based interventions aimed at the identified cognitions and perceptions.
METHODS


A randomized controlled trial was conducted in which OHPs were randomly assigned to a training program on the cognitions and perceptions of workers with a chronic disease (n = 29) or to a control group that did not receive training (n = 30). Participants received home assignments in which they had to identify the cognitions and perceptions of workers in video vignettes and had to indicate which interventions they would recommend to foster work participation. A generalized linear model repeated measures ANOVA was conducted to study the effects of the training program.
RESULTS


The results of the analyses showed an increase in the ability to identify the cognitions and perceptions of workers of OHPs who received the training compared to the control group (p < 0.001). The results also showed an increased ability to recommend evidence-based interventions aimed at these cognitions and perceptions (p < 0.001) as a result of participation in the training.
CONCLUSION


The training program helps OHPs to identify cognitions and perceptions and to recommend evidence-based interventions. This can support them in their activities to increase the work participation of workers with a chronic disease.",2022,The results of the analyses showed an increase in the ability to identify the cognitions and perceptions of workers of OHPs who received the training compared to the control group (p < 0.001).,"['occupational health professionals (OHPs', 'occupational health professionals on the cognitions and perceptions of workers', 'workers with a chronic disease']","['training program', 'training program on the cognitions and perceptions of workers with a chronic disease (n\u2009=\u200929) or to a control group that did not receive training']",['cognitions and perceptions of workers of OHPs'],"[{'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}]",,0.0145669,The results of the analyses showed an increase in the ability to identify the cognitions and perceptions of workers of OHPs who received the training compared to the control group (p < 0.001).,"[{'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'de Wit', 'Affiliation': 'Amsterdam UMC, Department of Public and Occupational Health, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. m.e.dewit@amsterdamumc.nl.'}, {'ForeName': 'Bedra', 'Initials': 'B', 'LastName': 'Horreh', 'Affiliation': 'Amsterdam UMC, Department of Public and Occupational Health, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.'}, {'ForeName': 'Carel T J', 'Initials': 'CTJ', 'LastName': 'Hulshof', 'Affiliation': 'Amsterdam UMC, Department of Public and Occupational Health, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.'}, {'ForeName': 'Haije', 'Initials': 'H', 'LastName': 'Wind', 'Affiliation': 'Amsterdam UMC, Department of Public and Occupational Health, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.'}, {'ForeName': 'Angela G E M', 'Initials': 'AGEM', 'LastName': 'de Boer', 'Affiliation': 'Amsterdam UMC, Department of Public and Occupational Health, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, PO Box 22700, 1100 DE, Amsterdam, The Netherlands.'}]",International archives of occupational and environmental health,['10.1007/s00420-021-01823-7']
1015,34873674,"A Double-Blind, Randomized, Placebo-Controlled Trial of Soluble Epoxide Hydrolase Inhibition in Patients with Aneurysmal Subarachnoid Hemorrhage.","BACKGROUND


Epoxyeicosatrienoates (EETs) are endogenous regulators of neuroinflammation and cerebral blood flow. Their metabolism to dihydroxyeicosatrienoates (DHETs) is catalyzed by soluble epoxide hydrolase (sEH). After subarachnoid hemorrhage (SAH), EETs' pathway amplification may be a therapeutic target for the prevention of delayed cerebral ischemia (DCI). We conducted a double-blind, placebo-controlled, phase Ib randomized trial of GSK2256294, a pharmacologic inhibitor of sEH, to evaluate the safety profile and to assess biomarkers of neurovascular inflammation in patients with aneurysmal SAH.
METHODS


Patients were randomly assigned to receive 10 mg of GSK2256294 or a placebo treatment once daily for 10 days, beginning within 72 hours after aneurysm rupture. The primary study end point was safety. Secondary end points included serum and cerebrospinal fluid (CSF) EETs-to-DHETs ratio, cytokine levels, and serum endothelial injury biomarkers, measured at day 7 and day 10 after SAH. Tertiary end points included neurologic status, disposition, length of stay, incidence of DCI, and mortality; these were assessed at hospital discharge and at 90 days.
RESULTS


Ten patients received GSK2256294 and nine patients received a placebo. There were no adverse events related to the study drug. GSK2256294 administration resulted in a significant increase in the EET/DHET ratio at day 7 and day 10 in serum, but not in the CSF. There was a trend for decreased CSF inflammatory cytokines following GSK2256294 administration, but this did not reach statistical significance.
CONCLUSIONS


GSK2256294 administration was safe and well tolerated in critically ill patients with SAH, producing an increase in serum EETs and the EET-to-DHET ratio. Our findings support future studies in a larger population to evaluate the role of sEH inhibition in the prevention of DCI after SAH and other forms of brain injury and inflammatory conditions.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: NCT03318783.",2022,"There was a trend for decreased CSF inflammatory cytokines following GSK2256294 administration, but this did not reach statistical significance.
","['critically ill patients with SAH', 'Patients with Aneurysmal Subarachnoid Hemorrhage', 'patients with aneurysmal SAH', 'Patients']","['placebo', 'Placebo', 'Soluble Epoxide Hydrolase Inhibition']","['neurologic status, disposition, length of stay, incidence of DCI, and mortality', 'safe and well tolerated', 'EET/DHET ratio', 'CSF inflammatory cytokines', 'serum and cerebrospinal fluid (CSF) EETs-to-DHETs ratio, cytokine levels, and serum endothelial injury biomarkers']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014628', 'cui_str': 'Epoxide hydrolase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0746866', 'cui_str': 'Neurological status'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.717626,"There was a trend for decreased CSF inflammatory cytokines following GSK2256294 administration, but this did not reach statistical significance.
","[{'ForeName': 'Ross P', 'Initials': 'RP', 'LastName': 'Martini', 'Affiliation': 'Oregon Anesthesiology Group, Portland, OR, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Siler', 'Affiliation': 'Department of Neurosurgery, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Cetas', 'Affiliation': 'Department of Neurosurgery, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Nabil J', 'Initials': 'NJ', 'LastName': 'Alkayed', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Miriam M', 'Initials': 'MM', 'LastName': 'Treggiari', 'Affiliation': 'Department of Anesthesiology, Yale University School of Medicine, 333 Cedar Street, TMP3, New Haven, CT, 06510, USA. miriam.treggiari@yale.edu.'}]",Neurocritical care,['10.1007/s12028-021-01398-8']
1016,35545957,Effect of a financial incentive on responses by Australian general practitioners to a postal survey: a randomised controlled trial.,,2022,,['Australian general practitioners to a postal survey'],['financial incentive'],[],"[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]",[],,0.149614,,"[{'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Zucca', 'Affiliation': 'College of Health, Medicine and Wellbeing, University of Newcastle, Newcastle, NSW.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Carey', 'Affiliation': 'College of Health, Medicine and Wellbeing, University of Newcastle, Newcastle, NSW.'}, {'ForeName': 'Rob W', 'Initials': 'RW', 'LastName': 'Sanson-Fisher', 'Affiliation': 'College of Health, Medicine and Wellbeing, University of Newcastle, Newcastle, NSW.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Rhee', 'Affiliation': 'University of Wollongong, Wollongong, NSW.'}, {'ForeName': 'Balakrishnan Kichu R', 'Initials': 'BKR', 'LastName': 'Nair', 'Affiliation': 'College of Health, Medicine and Wellbeing, University of Newcastle, Newcastle, NSW.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Newcastle, NSW.'}, {'ForeName': 'Tiffany-Jane', 'Initials': 'TJ', 'LastName': 'Evans', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Newcastle, NSW.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chiu', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Newcastle, NSW.'}]",The Medical journal of Australia,['10.5694/mja2.51523']
1017,35550159,Asleep DBS under ketamine sedation: Proof of concept.,"BACKGROUND


Deep brain stimulation (DBS) is commonly and safely performed for selective Parkinson's disease patients. Many centers perform DBS lead positioning exclusively under local anesthesia, to optimize brain microelectrode recordings (MER) and testing of stimulation-related therapeutic and side effects. These measures enable physiological identification of the DBS borders and subdomains based on electrophysiological properties like firing rates and patterns, intra-operative evaluation of therapeutic window, and improvement of lead placement accuracy. Nevertheless, due to the challenges of awake surgery, some centers use sedation or general anesthesia, despite the distortion of discharge properties and interference with clinical testing, resulting in potential impact on surgical outcomes. Thus, there is a need for a novel anesthesia regimen that enables sedation without compromising intra-operative monitoring.
OBJECTIVE


This open-label study investigates the use of low-dose ketamine for conscious sedation during microelectrode recordings and lead positioning in subthalamic nucleus (STN) DBS for Parkinson's disease patients.
METHODS


Three anesthetic regimens were retrospectively compared in 38 surgeries (74 MER trajectories, 5962 recording sites) across three DBS centers: 1) Interleaved propofol-ketamine (PK), 2) Interleaved propofol-awake (PA), and 3) Fully awake (AA).
RESULTS


All anesthesia regimens achieved satisfactory MER. Detection of STN borders and subdomains by expert electrophysiologist was similar between the groups. Electrophysiological signature of the STN under ketamine was not inferior to either control group. All patients completed stimulation testing.
CONCLUSIONS


This study supports a low-dose ketamine anesthesia regimen for DBS which allows microelectrode recordings and stimulation testing that are not inferior to those conducted under awake and propofol-awake regimens and may optimize patient experience. A prospective double-blind study that would also compare patients' satisfaction level and clinical outcome should be performed to confirm these findings.",2022,Electrophysiological signature of the STN under ketamine was not inferior to either control group.,"['Three anesthetic regimens were retrospectively compared in 38 surgeries (74 MER trajectories, 5962 recording sites) across three DBS centers: 1', ""selective Parkinson's disease patients"", ""Parkinson's disease patients""]","['Interleaved propofol-ketamine (PK), 2) Interleaved propofol-awake (PA), and 3) Fully awake (AA', 'Deep brain stimulation (DBS', 'ketamine anesthesia regimen', 'ketamine', 'STN under ketamine']",['satisfactory MER'],"[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025973', 'cui_str': 'Electrodes, Miniaturized'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0025973', 'cui_str': 'Electrodes, Miniaturized'}]",,0.0537225,Electrophysiological signature of the STN under ketamine was not inferior to either control group.,"[{'ForeName': 'Halen Baker', 'Initials': 'HB', 'LastName': 'Erdman', 'Affiliation': 'Department of Medical Neurobiology, Hebrew University, Jerusalem, Israel. Electronic address: Halen.baker@mail.huji.ac.il.'}, {'ForeName': 'Evgeniya', 'Initials': 'E', 'LastName': 'Kornilov', 'Affiliation': 'Department of Anesthesiology, Rabin Medical Center, Beilinson Hospital, Petach Tikvah, Israel; Department of Neurobiology, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Eilat', 'Initials': 'E', 'LastName': 'Kahana', 'Affiliation': 'Department of Anesthesiology, Rabin Medical Center, Beilinson Hospital, Petach Tikvah, Israel.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Zarchi', 'Affiliation': 'Intraoperative Neurophysiology Unit, Rabin Medical Center, Beilinson Hospital, Petach Tikvah, Israel.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Reiner', 'Affiliation': 'Department of Neurology, Rabin Medical Center, Beilinson Hospital, Petach Tikvah, Israel.'}, {'ForeName': 'Achinoam', 'Initials': 'A', 'LastName': 'Socher', 'Affiliation': 'Department of Neurology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Strauss', 'Affiliation': 'Department of Neurosurgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Firman', 'Affiliation': 'Department of Anesthesiology, Critical Care Medicine, and Pain Management, Hadassah Medical Center, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Israel', 'Affiliation': 'Department of Neurosurgery, Hadassah Medical Center, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Bergman', 'Affiliation': 'Department of Medical Neurobiology, Hebrew University, Jerusalem, Israel; Department of Neurosurgery, Hadassah Medical Center, Hebrew University, Jerusalem, Israel; The Edmond and Lily Safra Center for Brain Sciences, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Idit', 'Initials': 'I', 'LastName': 'Tamir', 'Affiliation': 'Department of Neurosurgery, Rabin Medical Center, Beilinson Hospital, Petach Tikvah, Israel. Electronic address: iditta1@clalit.org.il.'}]",Neurobiology of disease,['10.1016/j.nbd.2022.105747']
1018,35015037,Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial.,"Importance


Phase 3 trials have not compared semaglutide and liraglutide, glucagon-like peptide-1 analogues available for weight management.
Objective


To compare the efficacy and adverse event profiles of once-weekly subcutaneous semaglutide, 2.4 mg, vs once-daily subcutaneous liraglutide, 3.0 mg (both with diet and physical activity), in people with overweight or obesity.
Design, Setting, and Participants


Randomized, open-label, 68-week, phase 3b trial conducted at 19 US sites from September 2019 (enrollment: September 11-November 26) to May 2021 (end of follow-up: May 11) in adults with body mass index of 30 or greater or 27 or greater with 1 or more weight-related comorbidities, without diabetes (N = 338).
Interventions


Participants were randomized (3:1:3:1) to receive once-weekly subcutaneous semaglutide, 2.4 mg (16-week escalation; n = 126), or matching placebo, or once-daily subcutaneous liraglutide, 3.0 mg (4-week escalation; n = 127), or matching placebo, plus diet and physical activity. Participants unable to tolerate 2.4 mg of semaglutide could receive 1.7 mg; participants unable to tolerate 3.0 mg of liraglutide discontinued treatment and could restart the 4-week titration. Placebo groups were pooled (n = 85).
Main Outcomes and Measures


The primary end point was percentage change in body weight, and confirmatory secondary end points were achievement of 10% or more, 15% or more, and 20% or more weight loss, assessed for semaglutide vs liraglutide at week 68. Semaglutide vs liraglutide comparisons were open-label, with active treatment groups double-blinded against matched placebo groups. Comparisons of active treatments vs pooled placebo were supportive secondary end points.
Results


Of 338 randomized participants (mean [SD] age, 49 [13] years; 265 women [78.4%]; mean [SD] body weight, 104.5 [23.8] kg; mean [SD] body mass index, 37.5 [6.8]), 319 (94.4%) completed the trial, and 271 (80.2%) completed treatment. The mean weight change from baseline was -15.8% with semaglutide vs -6.4% with liraglutide (difference, -9.4 percentage points [95% CI, -12.0 to -6.8]; P < .001); weight change with pooled placebo was -1.9%. Participants had significantly greater odds of achieving 10% or more, 15% or more, and 20% or more weight loss with semaglutide vs liraglutide (70.9% of participants vs 25.6% [odds ratio, 6.3 {95% CI, 3.5 to 11.2}], 55.6% vs 12.0% [odds ratio, 7.9 {95% CI, 4.1 to 15.4}], and 38.5% vs 6.0% [odds ratio, 8.2 {95% CI, 3.5 to 19.1}], respectively; all P < .001). Proportions of participants discontinuing treatment for any reason were 13.5% with semaglutide and 27.6% with liraglutide. Gastrointestinal adverse events were reported by 84.1% with semaglutide and 82.7% with liraglutide.
Conclusions and Relevance


Among adults with overweight or obesity without diabetes, once-weekly subcutaneous semaglutide compared with once-daily subcutaneous liraglutide, added to counseling for diet and physical activity, resulted in significantly greater weight loss at 68 weeks.
Trial Registration


ClinicalTrials.gov Identifier: NCT04074161.",2022,"Gastrointestinal adverse events were reported by 84.1% with semaglutide and 82.7% with liraglutide.
","['338 randomized participants (mean [SD] age', '49 [13] years; 265 women [78.4%]; mean [SD] body weight, 104.5 [23.8] kg; mean [SD] body mass index, 37.5 [6.8]), 319 (94.4%) completed the trial, and 271 (80.2%) completed treatment', 'Adults With Overweight or Obesity', 'people with overweight or obesity', 'adults with body mass index of 30 or greater or 27 or greater with 1 or more weight-related comorbidities, without diabetes (N\u2009=\u2009338', 'Without Diabetes', 'adults with overweight or obesity without diabetes']","['placebo', 'liraglutide discontinued treatment and could restart the 4-week titration', 'Semaglutide vs liraglutide', 'Placebo', 'liraglutide', 'Weekly Subcutaneous Semaglutide vs Daily Liraglutide', 'liraglutide, 3.0 mg (both with diet and physical activity', 'matching placebo, or once-daily subcutaneous liraglutide, 3.0 mg (4-week escalation; n\u2009=\u2009127), or matching placebo, plus diet and physical activity']","['mean weight change', 'weight loss', 'Body Weight', 'Gastrointestinal adverse events', 'percentage change in body weight']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",338.0,0.530312,"Gastrointestinal adverse events were reported by 84.1% with semaglutide and 82.7% with liraglutide.
","[{'ForeName': 'Domenica M', 'Initials': 'DM', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management and Research, Arlington, Virginia.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Khalid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': ""O'Neil"", 'Affiliation': 'Weight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Sørrig', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Wizert', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.23619']
1019,35020019,To investigate treat and extend versus pro re nata regimen in neovascular age-related macular degeneration: results from the IDEM study.,"PURPOSE


The purpose of this study is to report the 24-month outcomes of a pro re nata (PRN) compared with a treat and extend (T&E) regimen in patients previously treated for neovascular age-related macular degeneration (nAMD).
METHODS


This was a 2-year prospective, single-center study. Previously treated patients for nAMD were randomized into two regimen groups: T&E and PRN groups. Main outcome measured was change in best corrected visual acuity (BCVA) from baseline to month 24. Secondary outcomes encompassed anatomical features such as central retinal thickness (CRT), number of intravitreal injections (IVI), and visits required.
RESULTS


A total of 124 eyes received the T&E (n = 61) or PRN (n = 63) regimen. At month 24, the mean BCVA change was -4.4 early treatment diabetic retinopathy study (ETDRS) letters (T&E) and -3.4 ETDRS letters (PRN), with a difference of +1.1 ETDRS letters (95% CI [-2.25]; p = 0.006). The mean change in CRT was -10.6 µm (T&E) and -7.9 µm (PRN), with a difference of +2.6 µm (95% CI [+19.2]; p = 0.004). The T&E group had received a mean of +4.6 more injections (95% CI [-7.06; -2.12]; p < 0.001) at month 24.
CONCLUSION


There was statistically proven non-inferiority between the PRN and T&E regimens in terms of visual and anatomical outcomes at 24 months, with significantly more IVI administered in the T&E regimen.",2022,"There was statistically proven non-inferiority between the PRN and T&E regimens in terms of visual and anatomical outcomes at 24 months, with significantly more IVI administered in the T&E regimen.","['patients previously treated for neovascular age-related macular degeneration (nAMD', 'neovascular age-related macular degeneration', 'Previously treated patients for nAMD']","['T&E', 'pro re nata (PRN', 'PRN', 'treat and extend (T&E) regimen']","['inferiority', 'mean BCVA change', 'anatomical features such as central retinal thickness (CRT), number of intravitreal injections (IVI), and visits required', 'corrected visual acuity (BCVA', 'mean change in CRT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",124.0,0.322354,"There was statistically proven non-inferiority between the PRN and T&E regimens in terms of visual and anatomical outcomes at 24 months, with significantly more IVI administered in the T&E regimen.","[{'ForeName': 'Emilien', 'Initials': 'E', 'LastName': 'Faudi', 'Affiliation': 'Department of Ophthalmology, Besançon University Hospital, Besançon, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Gauthier', 'Affiliation': 'Department of Ophthalmology, Besançon University Hospital, Besançon, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Delbosc', 'Affiliation': 'Department of Ophthalmology, Besançon University Hospital, Besançon, France.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Saleh', 'Affiliation': 'Department of Ophthalmology, Besançon University Hospital, Besançon, France. drmahersaleh@gmail.com.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-021-05543-z']
1020,35021994,Efficacy of dexmedetomidine as an adjunct to ropivacaine in bilateral dual-transversus abdominis plane blocks in patients with ovarian cancer who underwent cytoreductive surgery.,"OBJECTIVE


We sought to evaluate the postoperative control of pain and recovery in patients with ovarian cancer who underwent cytoreductive surgery by adding dexmedetomidine to ropivacaine in bilateral dual-transversus abdominis plane (Bd-TAP) blocks.
METHODS


We enrolled 90 patients with an American Society of Anesthesiologists physical status I to III undergoing open abdominal cytoreductive surgery in this study. Patients were randomized and assigned into three groups (TAP-R, TAP-DR, or CON) of 30 participants each. All of the patients received standardized general anesthesia, and postoperative Bd-TAP blocks were performed. The TAP-R, TAP-DR, and CON groups received Bd-TAP blocks with 0.3% ropivacaine, 0.3% ropivacaine and 0.5 μg/kg of dexmedetomidine, and 0.9% normal saline, respectively. All of the patients received patient-controlled analgesia (PCA) (formula, 100 μg of sufentanil and 16 mg of ondansetron diluted with normal saline to 100 mL). Flurbiprofen axetil was used as a rescue drug if the visual analog scale (VAS) score was more than four points. The first request time for PCA bolus; the VAS scores at 0, 6, 12, 24, and 48 h after operation; and the cumulative sufentanil consumption within 24 and 48 h, respectively, were compared. Pulmonary function was evaluated preoperatively and at 24 h after the operation. The use of the rescue drug was recorded. Postoperative functional recovery, including time to stand, time to walk, time to return of bowel function, time to readiness for discharge, and postoperative complications, were recorded.
RESULTS


Median values of the first request time for PCA of the TAP-R group was significantly prolonged compared to that of the CON group (median [interquartile range], 7.3 [6.5-8.0] hours vs. 3.0 [2.3-3.5] hours) (P < .001), while the TAP-DR group has the longest request time among the three groups (median [interquartile range], 13.5 [12.4-14.5] hours) (P < .001). The VAS scores at rest and upon coughing of the TAP-R group in the first 12 h were significantly lower than those of the CON group (P < 0.05), but showed no significant difference compared to those of the TAP-DR group. The VAS scores at rest and upon coughing were lower in the TAP-DR group at each time point compared to those of the CON group (P < .05). The cumulative sufentanil consumption in the TAP-DR group was significantly lower at 48 h (P = .04) after surgery than in the CON group, while there was no significant difference compared to that in the TAP-R group (P > .05). Less rescue analgesic was required by patients in the TAP-DR group than in the CON group (P < .05). Postoperative mean measured forced expiratory volume in 1 s (FEV 1 ) and FEV 1 /forced vital capacity values in the TAP-DR group were significantly higher than those of the CON group (P = .009), while there was no significant difference compared to those of the TAP-R group (P = .10). There was no significantly difference in postoperative functional recovery between TAP-DR and CON group (P > 0.05).
CONCLUSION


TAP blocks can provide effective pain relief up to 12 h postoperatively without a significant improvement in postoperative pulmonary function. The addition of dexmedetomidine to ropivacaine for Bd-TAP block prolonged the first bolus time of PCA when compared to that in the TAP-R group and decreased sufentanil consumption and the need of rescue analgesia relative to in the CON group at 48 h postoperative. The procedure provided better postoperative analgesia and improved postoperative pulmonary function relative to the CON group. Our results indicate that dexmedetomidine as an adjuvant of Bd-TAP can provide effective pain relief up to 48 h.",2022,Less rescue analgesic was required by patients in the TAP-DR group than in the CON group (P < .05).,"['90 patients with an American Society of Anesthesiologists physical status', 'patients with ovarian cancer who underwent cytoreductive surgery by adding', 'patients with ovarian cancer who underwent cytoreductive surgery']","['dexmedetomidine to ropivacaine', 'ropivacaine', 'TAP-DR and CON', 'dexmedetomidine', 'Flurbiprofen axetil', 'CON', 'patient-controlled analgesia (PCA) (formula, 100\u2009μg of sufentanil and 16\u2009mg of ondansetron diluted with normal saline', 'TAP blocks', 'ropivacaine, 0.3% ropivacaine', 'III undergoing open abdominal cytoreductive surgery']","['Postoperative mean measured forced expiratory volume in 1 s (FEV 1 ) and FEV 1 /forced vital capacity values', 'postoperative functional recovery', 'Less rescue analgesic', 'VAS scores at rest and upon coughing', 'effective pain relief', 'VAS scores', 'Postoperative functional recovery, including time to stand, time to walk, time to return of bowel function, time to readiness for discharge, and postoperative complications', 'postoperative pulmonary function', 'visual analog scale (VAS) score', 'longest request time', 'sufentanil consumption', 'Pulmonary function', 'cumulative sufentanil consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",90.0,0.303835,Less rescue analgesic was required by patients in the TAP-DR group than in the CON group (P < .05).,"[{'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics and Gynaecology, First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.'}, {'ForeName': 'Yan-Hu', 'Initials': 'YH', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, Anhui, China. zhangw0310@sina.com.'}]",BMC anesthesiology,['10.1186/s12871-021-01542-z']
1021,35031139,Routine systematic sampling versus targeted sampling during endobronchial ultrasound: A randomized feasibility trial.,"OBJECTIVE


Triple normal lymph nodes, appearing benign on computed tomography, positron emission tomography, and endobronchial ultrasound, have less than a 6% probability of malignancy. We hypothesized that targeted sampling (TS), which omits biopsy of triple normal lymph nodes during endobronchial ultrasound, is not an inferior staging strategy to systematic sampling (SS) of all lymph nodes.
METHODS


A prospective randomized feasibility trial was conducted to decide on the progression to a pan-Canadian trial comparing TS with SS. Patients with cN0-N1 non-small cell lung cancer undergoing endobronchial ultrasound were randomized to TS or SS. Lymph nodes in the TS arm crossed over to receive SS. Progression criteria included recruitment rate (70% minimum), procedure length (no significant increase for TS), and incidence of missed nodal metastasis (<6%). Mann-Whitney U test and McNemar's test on paired proportions were used for statistical comparisons.
RESULTS


The progression criterion of 70% recruitment rate was achieved early, triggering a planned early stoppage of the trial. Nineteen patients were allocated to each arm. The median procedure length for TS was significantly shorter than SS (3.07 vs 19.07 minutes; P < .001). After crossover analysis, 5.45% (95% confidence interval, 1.87-14.85) of lymph nodes in the TS arm were upstaged from N0 to N2, but this incidence of missed nodal metastasis was below the 6% threshold. During surgical resection, the nodal upstaging incidence from N0 to N2 was 0% for 15 lymph nodes in each arm.
CONCLUSIONS


Progression criteria to a pan-Canadian, noninferiority crossover trial comparing TS with SS have been met, and such a trial is warranted.",2022,"During surgical resection, the nodal upstaging incidence from N0 to N2 was 0% for 15 lymph nodes in each arm.
","['Nineteen patients', 'Patients with cN0-N1 non-small cell lung cancer undergoing endobronchial ultrasound']","['Routine systematic sampling versus targeted sampling during endobronchial ultrasound', 'TS or SS', 'TS with SS']","['missed nodal metastasis', 'median procedure length for TS', 'TS), and incidence of missed nodal metastasis', 'procedure length', 'nodal upstaging incidence']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}]","[{'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",19.0,0.113457,"During surgical resection, the nodal upstaging incidence from N0 to N2 was 0% for 15 lymph nodes in each arm.
","[{'ForeName': 'Kerrie A', 'Initials': 'KA', 'LastName': 'Sullivan', 'Affiliation': 'Division of Thoracic Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Farrokhyar', 'Affiliation': 'Division of Thoracic Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Grigorios I', 'Initials': 'GI', 'LastName': 'Leontiadis', 'Affiliation': 'Division of Gastroenterology and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Yogita S', 'Initials': 'YS', 'LastName': 'Patel', 'Affiliation': 'Division of Thoracic Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Isabella F', 'Initials': 'IF', 'LastName': 'Churchill', 'Affiliation': 'Division of Thoracic Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Hylton', 'Affiliation': 'Division of Thoracic Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada; Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew J E', 'Initials': 'AJE', 'LastName': 'Seely', 'Affiliation': 'Division of Thoracic Surgery, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Spicer', 'Affiliation': 'Division of Thoracic Surgery, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Biniam', 'Initials': 'B', 'LastName': 'Kidane', 'Affiliation': 'Section of Thoracic Surgery, University of Manitoba, Winnipeg, Manitoba, Canada; Research Institute in Oncology and Hematology, Cancer Care Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Turner', 'Affiliation': 'Division of Thoracic Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yasufuku', 'Affiliation': 'Division of Thoracic Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Waël C', 'Initials': 'WC', 'LastName': 'Hanna', 'Affiliation': 'Division of Thoracic Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada. Electronic address: hannaw@mcmaster.ca.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2021.11.062']
1022,35014162,Does deep neuromuscular blockade provide improved outcomes in low pressure laparoscopic colorectal surgery? A single blinded randomized pilot study.,"BACKGROUND


Low intra-abdominal pressure during laparoscopic colorectal surgery may improve outcomes and reduce hospital stay, in addition to Enhanced Recovery After Surgery (ERAS) protocols. There is concern that low pressure reduces laparoscopic vision and may increase surgical complications. Deep neuromuscular blockade may abrogate any reduction in vision of low-pressure pneumoperitoneum. However, antagonism of deep neuromuscular blockade at completion of surgery necessitates the use of sugammadex, which is prohibitively expensive, if there are no surgical benefits and warrants further study.
METHODS


A single institution, single blinded randomized controlled pilot study was performed comparing deep to moderate neuromuscular blockade in major laparoscopic colorectal surgery.
RESULTS


Thirty-eight patients were randomized to deep or moderate neuromuscular blockade. There were no statistically significant differences between groups, when comparing key patient demographics, or surgeon satisfaction with view, which required increased pressure or further relaxation demands. The deep blockade group had increased QoR15 scores and a decrease in pain, C-Reactive Protein (CRP) measurements and operating times, although were non-significant. The moderate group had slightly higher incidents of Medical Emergency Team (MET) calls and more severe complications, although were non-significant.
CONCLUSIONS


Low intra-abdominal pressure in laparoscopic colorectal surgery is feasible and allows adequate surgical visualization, regardless of the degree of neuromuscular blockade. Potential benefits of deep neuromuscular blockade may include improved pain and quality of recovery and a possible reduction of complications; however a larger cohort is required to confirm this. Future ERAS protocols may consider deep neuromuscular blockade with low intra-abdominal pressure to further benefit patients.",2022,"The deep blockade group had increased QoR15 scores and a decrease in pain, C-Reactive Protein (CRP) measurements and operating times, although were non-significant.","['Thirty-eight patients', 'major laparoscopic colorectal surgery']",[],"['pain, C-Reactive Protein (CRP) measurements and operating times', 'QoR15 scores', 'hospital stay', 'pain and quality of recovery', 'Medical Emergency Team (MET) calls and more severe complications', 'surgical complications']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",38.0,0.16409,"The deep blockade group had increased QoR15 scores and a decrease in pain, C-Reactive Protein (CRP) measurements and operating times, although were non-significant.","[{'ForeName': 'Darren John', 'Initials': 'DJ', 'LastName': 'Lowen', 'Affiliation': 'Department of Anaesthesia & Perioperative Medicine, Northern Health, Epping, Victoria, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Hodgson', 'Affiliation': 'Division of Surgery, Northern Health, Epping, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tacey', 'Affiliation': 'Northern Centre for Health, Education and Research, Northern Health, Epping, Victoria, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barclay', 'Affiliation': 'Northern Clinical School, Melbourne Medical School, The University of Melbourne, Parkville, Victoria, Australia.'}]",ANZ journal of surgery,['10.1111/ans.17458']
1023,35014061,"Pharmacokinetics, pharmacodynamics and safety of BAY 2433334, a novel activated factor XI inhibitor, in healthy volunteers: A randomized phase 1 multiple-dose study.","AIM


To evaluate BAY 2433334, an oral activated factor XI (FXIa) inhibitor, in volunteers.
METHODS


Phase 1 study of healthy men at a German centre. Part A: randomized, single-blind, multiple dose-escalation study of BAY 2433334 (25/50/100 mg once daily [OD]) vs. placebo. Part B: similar design to Part A; evaluated BAY 2433334 25 mg twice daily. Part C: nonrandomized, open-label study; evaluated potential interactions between BAY 2433334 (25/75 mg OD) and midazolam (7.5 mg), a CYP3A4 index substrate. Primary variables: treatment-emergent adverse events (TEAEs; Parts A and B); area under the plasma concentration-time curve (AUC) and maximum plasma concentration of midazolam and α-hydroxymidazolam (Part C).
STUDY PERIOD


18 days plus follow-up visit.
RESULTS


Parts A and B: 36 participants randomized to BAY 2433334; 12 to placebo. Part C: 48 participants assigned to BAY 2433334 plus midazolam. BAY 2433334 was well tolerated in all study parts. AUC and maximum plasma concentration of BAY 2433334 in plasma appeared dose proportional over 25-100 mg OD, with low-to-moderate variability in pharmacokinetic parameters. Multiple dosing caused minor-to-moderate accumulation and a mean terminal half-life (15.8-17.8 h) supporting once-daily dosing. Dose-dependent FXIa activity inhibition and activated partial thromboplastin time prolongation were observed. BAY 2433334 appeared to have a minor effect on AUC for midazolam (ratio [90% confidence interval]: 1.1736 [1.0963-1.2564]) and α-hydroxymidazolam (0.9864 [0.9169-1.0612]) only for BAY 2433334 75 mg OD on day 10.
CONCLUSION


Multiple dosing of BAY 2433334 in healthy volunteers was well tolerated, with a predictable pharmacokinetic/pharmacodynamic profile and no clinically relevant CYP3A4 induction or inhibition.",2022,"Multiple dosing of BAY 2433334 in healthy volunteers was well tolerated, with a predictable pharmacokinetic/pharmacodynamic profile and no clinically relevant CYP3A4 induction or inhibition.","['volunteers', 'healthy volunteers', 'healthy men at a German centre']","['placebo', 'α-hydroxymidazolam', 'midazolam', 'oral activated factor XI (FXIa) inhibitor']","['plasma concentration-time curve', 'emergent adverse events (TEAEs; Parts A and B); AUC and C max  of midazolam and α-hydroxymidazolam (Part C', 'FXIa activity inhibition and activated partial thromboplastin time prolongation']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015524', 'cui_str': 'Coagulation factor XIa'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}]",36.0,0.0402877,"Multiple dosing of BAY 2433334 in healthy volunteers was well tolerated, with a predictable pharmacokinetic/pharmacodynamic profile and no clinically relevant CYP3A4 induction or inhibition.","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Kubitza', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heckmann', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Distler', 'Affiliation': 'ClinStat GmbH, Cologne, Germany.'}, {'ForeName': 'Annemone', 'Initials': 'A', 'LastName': 'Koechel', 'Affiliation': 'CRS Clinical Research Services Wuppertal GmbH, Wuppertal, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schwers', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Kanefendt', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.15230']
1024,35016497,The effect of ultrasound-guided bilateral thoracic retrolaminar block on analgesia after pediatric open cardiac surgery: a randomized controlled double-blind study.,"BACKGROUND


The thoracic retrolaminar block (TRLB) is a relatively new regional analgesia technique that can be used as an alternative to the thoracic paravertebral block. This study aimed to evaluate the postoperative analgesia effects of ultrasound-guided TRLB in children undergoing open cardiac surgery via median sternotomy incision.
METHODS


Sixty-six patients aged 2-8 years were recruited. In the TRLB group, 0.25% bupivacaine 0.4 ml/kg was injected into the retrolaminar space on both sides at the level of the T4 lamina. Patients in the control group were injected with 0.9% saline. The primary outcome measure was fentanyl consumption in the first 24 h post-extubation. The secondary outcome measures were the total intraoperative fentanyl consumption, postoperative modified objective pain score (MOPS), and time to extubation.
RESULTS


The total intraoperative fentanyl requirements and fentanyl consumption in the first 24 h post-extubation were significantly lower (P < 0.001) in the TRLB group (9.3 ± 1.2; 6.9 ± 2.1 μg/kg, respectively) than in the control group (12.5 ± 1.4; 16.6 ± 2.8, respectively). The median (Q1, Q3) time to extubation was significantly shorter (P < 0.001) in the TRLB group (2 [1, 3] h) than in the control group (6 [4.5, 6] h). The MOPS was significantly lower (P < 0.05) in the TRLB group than in the control group at 0, 2, 4, 8, 12 and 16 h post-extubation.
CONCLUSIONS


Bilateral ultrasound-guided TRLB is effective in providing postoperative analgesia in children undergoing open cardiac surgery via median sternotomy incision.",2022,"Conclusions


Bilateral ultrasound-guided TRLB is effective in providing postoperative analgesia in children undergoing open cardiac surgery via median sternotomy incision.","['analgesia after pediatric open cardiac surgery', 'Methods\n\n\nSixty-six patients aged 2 to 8 years undergoing cardiac open cardiac surgery via median sternotomy incision were recruited', 'children undergoing open cardiac surgery via median sternotomy incision']","['ultrasound-guided bilateral thoracic retrolaminar block', 'Bilateral ultrasound-guided TRLB', 'ultrasound-guided TRLB', 'bupivacaine', 'TRLB', '\n\n\nThoracic retrolaminar block (TRLB']","['mean±SD total intraoperative fentanyl requirements', '24h post-extubation fentanyl consumption', 'MOPS', 'total intraoperative fentanyl consumption, postoperative modified objective pain score (MOPS) and time to extubation', 'median (Q1, Q3) time (h) of extubation and the mean±SD time (h) of ICU length of stay']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",66.0,0.440555,"Conclusions


Bilateral ultrasound-guided TRLB is effective in providing postoperative analgesia in children undergoing open cardiac surgery via median sternotomy incision.","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Sherif I', 'Initials': 'SI', 'LastName': 'Elfayoumy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Portsaid University, Portsaid, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Magdy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Elmorsy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Damietta University, Damietta, Egypt.'}, {'ForeName': 'Mahmoud M', 'Initials': 'MM', 'LastName': 'ALseoudy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Korean journal of anesthesiology,['10.4097/kja.21466']
1025,35019901,"High-Intensity Interval Training in Polycystic Ovary Syndrome: A Two-Center, Three-Armed Randomized Controlled Trial.","PURPOSE


Exercise training is recommended to improve cardiometabolic health and fertility in women with polycystic ovary syndrome (PCOS), yet there are few randomized controlled trials on the effects of different exercise protocols on clinical reproductive outcomes. Our aim was to determine the effect of high-intensity interval training (HIT) on menstrual frequency, as a proxy of reproductive function, in women with PCOS.
METHODS


The IMPROV-IT study was a two-center randomized controlled trial undertaken in Norway and Australia. Women with PCOS were eligible for inclusion. After stratification for body mass index <27 or ≥27 kg·m-2 and study center, participants were randomly allocated (1:1:1) to high-volume HIT (HV-HIT), low-volume HIT (LV-HIT), or a control group. Measurements were assessed at baseline, after the 16-wk exercise intervention, and at 12-month follow-up. The primary outcome was menstrual frequency after 12 months. Secondary outcomes included markers of cardiometabolic and reproductive health, quality of life, and adherence to and enjoyment of HIT.
RESULTS


We randomly allocated 64 participants to the HV-HIT (n = 20), LV-HIT (n = 21), or control group (n = 23). There were no differences in menstrual frequency at 12 months between the LV-HIT and control groups (frequency ratio, 1.02; 95% confidence interval [CI], 0.73-1.42), the HV-HIT and control groups (frequency ratio, 0.93; 95% CI, 0.67-1.29), or the LV-HIT and HV-HIT groups (frequency ratio, 1.09; 95% CI, 0.77-1.56). Menstrual frequency increased in all groups from baseline to 12 months. More participants became pregnant in the LV-HIT group (n = 5) than in the control group (n = 0, P = 0.02).
CONCLUSIONS


A semisupervised HIT intervention did not increase menstrual frequency in women with PCOS.Clinical Trial Registration Number:ClinicalTrials.gov (NCT02419482).",2022,"There were no differences in menstrual frequency at 12 months between LV-HIT and control (frequency-ratio 1.02, 95% CI 0.73-1.42), HV-HIT and control (frequency-ratio 0.93, 95% CI 0.67-1.29) or LV-HIT and HV-HIT (frequency-ratio 1.09, 95% CI 0.77-1.56).","['Women with PCOS were eligible for inclusion', 'women with polycystic ovary syndrome (PCOS', 'women with PCOS', 'Polycystic Ovary Syndrome']","['Exercise training', 'High-Intensity Interval Training', 'high-intensity interval training (HIT', 'LV-HIT']","['markers of cardiometabolic and reproductive health, quality of life, and adherence to and enjoyment of HIT', 'cardiometabolic health and fertility', 'menstrual frequency', 'Menstrual frequency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",64.0,0.168652,"There were no differences in menstrual frequency at 12 months between LV-HIT and control (frequency-ratio 1.02, 95% CI 0.73-1.42), HV-HIT and control (frequency-ratio 0.93, 95% CI 0.67-1.29) or LV-HIT and HV-HIT (frequency-ratio 1.09, 95% CI 0.77-1.56).","[{'ForeName': 'Ida A', 'Initials': 'IA', 'LastName': 'Kiel', 'Affiliation': ''}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Lionett', 'Affiliation': ''}, {'ForeName': 'Evelyn B', 'Initials': 'EB', 'LastName': 'Parr', 'Affiliation': 'Exercise and Nutrition Research Programme, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, AUSTRALIA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jones', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UNITED KINGDOM.'}, {'ForeName': 'Maria A H', 'Initials': 'MAH', 'LastName': 'Røset', 'Affiliation': ""Department of Obstetrics and Gynaecology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, NORWAY.""}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, NORWAY.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hawley', 'Affiliation': 'Exercise and Nutrition Research Programme, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, AUSTRALIA.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': ""Department of Obstetrics and Gynaecology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, NORWAY.""}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Moholdt', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002849']
1026,35019886,A novel pivot ankle/foot prosthesis reduces sound side loading and risk for osteoarthritis: a pragmatic randomized controlled trial.,"BACKGROUND


Individuals with unilateral transtibial amputation are at risk of abnormal mechanical joint loading and development of osteoarthritis on sound side joint structures.
OBJECTIVES


This study describes the spatiotemporal and kinetic and kinematic parameters related to osteoarthritis in participants while using (A) a solid-ankle cushioned-heel prosthesis (SACH), (B) a conventional energy storage and return (ESAR) foot prosthesis, and (C) a novel ESAR (N-ESAR) foot prosthesis.
STUDY DESIGN


A pragmatic randomized controlled trial.
METHODS


K3-K4 ambulators used three feet in a 2-week randomized cross-over order. Kinetics of vertical ground reaction forces (vGRFs) and 3D kinematics of joint angles were integrated to provide normalized parameters. Data were analyzed using one way and mixed model Analysis of variance (ANOVAs) (p < 0.05) and Cohen d statistic.
RESULTS


Twenty participants, aged 40 ± 16 years with body mass index of 24.7 ± 3.6 kg/m2, experienced minimal change in the spatiotemporal parameters between feet. Participants using the N-ESAR foot prosthesis experienced reduced peak knee external adduction moment (p = 0.030), peak vGRFs (p < 0.001), and peak loading rate of vGRFs (p = 0.030). Peak knee flexion moments only changed when using the solid-ankle cushioned-heel prosthesis, in a positive direction (p = 0.014). Using the N-ESAR prosthesis also increased peak distal shank power during late stance phase (p < 0.001).
CONCLUSIONS


A novel ankle/foot ESAR prosthesis reduces loading on the sound side. With extended use of the N-ESAR foot prosthesis, these findings may provide the prosthesis user with improved outcomes related to sound side loading and development of osteoarthritis.",2022,"Participants using the N-ESAR foot prosthesis experienced reduced peak knee external adduction moment (p = 0.030), peak vGRFs (p < 0.001), and peak loading rate of vGRFs (p = 0.030).","['osteoarthritis', 'Individuals with unilateral transtibial amputation', 'K3-K4 ambulators used three feet in a 2-week randomized cross-over order', 'participants while using (A) a', 'Twenty participants, aged 40 ± 16 years with body mass index of 24.7 ± 3.6 kg/m2']","['solid-ankle cushioned-heel prosthesis (SACH), (B) a conventional energy storage and return (ESAR) foot prosthesis, and (C) a novel ESAR (N-ESAR) foot prosthesis', 'novel pivot ankle/foot prosthesis']","['Kinetics of vertical ground reaction forces (vGRFs) and 3D kinematics of joint angles', 'Peak knee flexion moments', 'peak vGRFs', 'peak knee external adduction moment', 'peak distal shank power', 'peak loading rate of vGRFs']","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0180249', 'cui_str': 'Cushion'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444675', 'cui_str': 'Shank'}]",,0.0969835,"Participants using the N-ESAR foot prosthesis experienced reduced peak knee external adduction moment (p = 0.030), peak vGRFs (p < 0.001), and peak loading rate of vGRFs (p = 0.030).","[{'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Runciman', 'Affiliation': 'Department of Sport Science, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cockcroft', 'Affiliation': 'Institute of Sport and Exercise Medicine, Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Derman', 'Affiliation': 'Institute of Sport and Exercise Medicine, Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.'}]",Prosthetics and orthotics international,['10.1097/PXR.0000000000000079']
1027,35029238,"A randomized, multi-center, open-label study to compare the safety and efficacy between afatinib monotherapy and combination therapy of afatinib and HAD-B1 for the locally advanced or metastatic NSCLC patients with EGFR mutations: Erratum.",,2022,,['locally advanced or metastatic NSCLC patients with EGFR mutations'],['afatinib and HAD-B1'],['safety and efficacy'],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0289369,,[],Medicine,['10.1097/MD.0000000000028585']
1028,34920097,A phase II randomized trial to evaluate the long-term (12-week) efficacy and safety of OC-01 (varenicline solution) nasal spray for dry eye disease: The MYSTIC study.,"PURPOSE


Dry eye disease is characterized by loss of tear film stability. OC-01 (varenicline solution) is a small-molecule nicotinic acetylcholine receptor agonist administered as a nasal spray that stimulates tear production.
METHODS


In MYSTIC (NCT03873246) patients aged ≥22 years with dry eye disease were randomized 1:1:1 to OC-01 0.03 mg, OC-01 0.06 mg, or vehicle (n = 41 per group), administered twice daily via intranasal spray, for 12 weeks (84 days). Primary efficacy endpoint was mean change from baseline in anesthetized Schirmer's test score (STS) in study eye at day (D) 84.
RESULTS


Patients receiving OC-01 0.03 and 0.06 mg had statistically significantly increased tear production at D84 versus vehicle; least squares mean changes from baseline in STS were 10.8 mm and 11.0 mm for OC-01 0.03 and 0.06 mg, respectively. A trend toward a higher proportion of patients experiencing ≥10-mm improvement in STS from baseline was observed with OC-01 0.03 mg (36.6%; p > 0.05), and was significant for OC-01 0.06 mg (48.8%; p = 0.024), versus vehicle (24.4%). Non-ocular treatment-emergent adverse events (TEAEs) were reported by 21 patients; the most common was sneezing (OC-01 0.03 mg, 2 [4.9%]; OC-01 0.06 mg, 3 [7.3%]), with similar frequencies between treatment groups. No severe or serious TEAEs were reported.
CONCLUSIONS


OC-01 (varenicline solution) nasal spray improved tear production in patients with dry eye disease over a long-term (12-week) period, and represents a receptor neuro-activator with a nasal route of administration that spares the ocular surface to stimulate tear production.",2022,"RESULTS


Patients receiving OC-01 0.03 and 0.06 mg had statistically significantly increased tear production at D84 versus vehicle; least squares mean changes from baseline in STS were 10.8 mm and 11.0 mm for OC-01 0.03 and 0.06 mg, respectively.","['patients aged ≥22 years with dry eye disease', 'dry eye disease', 'patients with dry eye disease']","['OC-01 (varenicline solution', 'OC-01 (varenicline solution) nasal spray', 'OC-01 0.03\xa0mg, OC-01 0.06\xa0mg, or vehicle']","['severe or serious TEAEs', 'tear production', ""anesthetized Schirmer's test score (STS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0423153', 'cui_str': 'Lacrimation'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0551605,"RESULTS


Patients receiving OC-01 0.03 and 0.06 mg had statistically significantly increased tear production at D84 versus vehicle; least squares mean changes from baseline in STS were 10.8 mm and 11.0 mm for OC-01 0.03 and 0.06 mg, respectively.","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Quiroz-Mercado', 'Affiliation': 'Asociación Para Evitar la Ceguera en Mexico, Retina Service, Vicente Garcia Torres # 46, Coyoacan, 04330, Mexico City, Mexico.'}, {'ForeName': 'Everardo', 'Initials': 'E', 'LastName': 'Hernandez-Quintela', 'Affiliation': 'Asociación Para Evitar la Ceguera en Mexico, Retina Service, Vicente Garcia Torres # 46, Coyoacan, 04330, Mexico City, Mexico; Asociación para Evitar la Ceguera en México (APEC), Cornea and Refractive Surgery Service, Mexico City, Mexico.'}, {'ForeName': 'Kuei Hsun', 'Initials': 'KH', 'LastName': 'Chiu', 'Affiliation': 'Firma Clinical Research, Hunt Valley, MD, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Henry', 'Affiliation': 'Firma Clinical Research, Hunt Valley, MD, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Nau', 'Affiliation': 'Oyster Point Pharma, Inc., Princeton, NJ, USA. Electronic address: jnau@oysterpointrx.com.'}]",The ocular surface,['10.1016/j.jtos.2021.12.007']
1029,35018643,Clinical effects of low-dose esketamine for anaesthesia induction in the elderly: A randomized controlled trial.,"WHAT IS KNOWN AND OBJECTIVE


Esketamine is an N-methyl-D-aspartic acid (NMDA) receptor antagonist, which has stronger sedative and analgesic effects and fewer adverse events than ketamine. The effects of low-dose esketamine on haemodynamics and postoperative quality of recovery in elderly patients have not been evaluated. To evaluate whether low-dose esketamine can be safely used for anaesthesia induction in the elderly.
METHODS


Eighty elderly patients were selected for unilateral total knee replacement under general anaesthesia from February 2021 to August 2021. Patients were randomly divided into two groups (n = 40): control group (C group) and esketamine group (K group). During induction of anaesthesia, the control group was intravenously injected with normal saline of equal volume, and the esketamine group was intravenously injected with 0.2-mg/kg esketamine. Both groups were induced by etomidate, sufentanil and rocuronium and maintained by combined intravenous and inhaled anaesthesia during operation.
MAIN OUTCOME MEASURES


HR, SBP, DBP, MAP and BIS values were recorded before induction of anaesthesia (T 0  ), immediately before endotracheal intubation (T 1  ), 1min(T 2  ) and 5min(T 3  ) after endotracheal intubation, surgical skin incision (T 4  ), 1min(T 5  ) and 5min(T 6  ) after surgical skin incision.
RESULTS


Compared with the C group, SBP, DBP, MAP, HR and BIS of the K group were significantly higher at T 1  -T 3  (p < 0.05). There were no significant differences in SBP, DBP, MAP, HR and BIS between the two groups at T 4  -T 6  (p > 0.05). Compared with T 0  , SBP, MAP and BIS values of the two groups at T 1  -T 6  were decreased (p < 0.05). DBP of the K group at T 2  was not significantly different from DBP at T 0  (p < 0.05), but DBP of the C group decreased from T 1  to T 6  (p < 0.05). Compared with T 0  , HR in both groups decreased at T 1  , T 3  , T 4  , T 5  and T 6  (p < 0.05). Compared with the C group, the incidence of cough in the K group was significantly lower (p < 0.05); There was no significant difference in the number of myoclonus during induction between the two groups (p > 0.05). Compared with the C group, the number of hypotension episodes in the K group during induction was much smaller (p < 0.05). There were no significant differences in the incidence of hypertension, bradycardia and tachycardia (p > 0.05). There were no significant differences in postoperative recovery quality and incidence of adverse events between the two groups (p > 0.05).
WHAT IS NEW AND CONCLUSION


Low-dose esketamine for anaesthesia induction in the elderly undergoing knee arthroplasty may better maintain the stability of haemodynamics and has no adverse effect on the quality of early recovery after operation.",2022,"There were no significant differences in SBP, DBP, MAP, HR and BIS between the two groups at T 4  -T 6  (p > 0.05).","['elderly patients', 'elderly undergoing knee arthroplasty', 'elderly', 'Eighty elderly patients were selected for unilateral total knee replacement under general anaesthesia from February 2021 to August 2021']","['normal saline of equal volume, and the esketamine group was intravenously injected with 0.2-mg/kg esketamine', 'control group (C group) and esketamine', 'etomidate, sufentanil and rocuronium', 'low-dose esketamine', 'ketamine']","['number of hypotension episodes', 'SBP, DBP, MAP, HR and BIS', 'HR, SBP, DBP, MAP and BIS', 'incidence of cough', 'SBP, MAP and BIS values', 'incidence of hypertension, bradycardia and tachycardia', 'number of myoclonus during induction', 'DBP', 'postoperative recovery quality and incidence of adverse events', 'haemodynamics and postoperative quality of recovery']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0027066', 'cui_str': 'Myoclonus'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",80.0,0.0319266,"There were no significant differences in SBP, DBP, MAP, HR and BIS between the two groups at T 4  -T 6  (p > 0.05).","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Anqi', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13604']
1030,35031521,Daily meditation program for anxiety in individuals admitted to the antepartum unit: a multicenter randomized controlled trial (MEDITATE).,"BACKGROUND


Inpatient antepartum women have higher levels of anxiety than outpatient. Former randomized trials using mindful meditation programs to decrease maternal anxiety have conflicting results; some studies showed a considerable decrease in anxiety levels, whereas others showed no difference. A paucity of trials exist using mindful meditation for maternal anxiety in the inpatient antepartum population; most studies focus on the outpatient clinic population. Because of inpatient acuity and anxiety factors, we conducted a randomized trial to target this population.
OBJECTIVE


This study aimed to compare anxiety levels on day 4 of either routine care or routine care plus a twice-daily application-based mindful meditation program in women admitted to the antepartum unit.
STUDY DESIGN


In a multisite randomized trial (ClinicalTrials.gov Identifier: NCT03737279), women admitted to the antepartum units were randomized to either routine care plus educational pamphlets (control arm) or routine care plus a twice-daily application-based mindful meditation program (intervention arm). The inclusion criteria were age of at least 18 years, gestational age of at least 23 weeks, planned inpatient care for >3 days from randomization, and care by our university physician team. The primary outcome was maternal state anxiety level (measured using the validated State-Trait Anxiety Inventory) on day 4 (randomization being day 1). The secondary outcomes included stress (measured using the Perceived Stress Scale) and depression (measured using the Edinburgh Depression Scale) on day 4, latency period from randomization to delivery, patient experience, number of meditation sessions, and total meditation time. A total of 56 women were needed for 90% power to detect a decrease in the primary outcome by 30% in the intervention group, compared with the control group. All women were observed using an intention-to-treat analysis. We compared the continuous variables using the Wilcoxon rank-sum test or t test and the categorical variables using the chi-squared test or the Fisher exact test.
RESULTS


From March 4, 2019, to December 20, 2019, 412 women were screened for eligibility, 77 women (18.7%) were found eligible, and 56 women (72.7%) were randomized with 28 women in each group. Of note, 96.4% of women completed at least 1 meditation session, and 39.3% of women completed all meditation sessions. The mean score of the anxiety level using the State-Trait Anxiety Inventory on day 4 was not significantly different (P=.24) between the control group (42.0±10.8) and meditation group (37.5±13.1). A decreased anxiety score from day 1 to day 4 was seen in both the control group and meditation group (-4.7 vs -9.4, respectively; P=.12). The rate of abnormal State-Trait Anxiety Inventory scores on day 4 was not significantly different between the control group and meditation group (62% vs 45%, respectively; P=.28). When asked about the experience with the research trial, 88.8% of women in the control group and 89.5% of women in the meditation group reported a positive experience.
CONCLUSION


Compared with the control group, a twice-daily application-based mindful meditation program for women admitted to the antepartum unit did not considerably decrease the anxiety score on day 4. However, >88% of women in both groups had a positive experience with the nonpharmacologic intervention.",2022,"A decreased anxiety score from day 1 to day 4 was seen in both the control group (- 4.7) and the meditation group (- 9.4, p=0.12).","['individuals admitted to the antepartum unit', 'Admitted to the Antepartum Unit', 'Inclusion criteria were age of at least 18 years, gestational age of at least 23 weeks, planned inpatient care for more than 3 days from randomization, and care by our university physician team', 'individuals admitted to the antepartum units', 'From March 4, 2019 through December 20, 2019, 412 women were screened for eligibility, 77 (18.7%) found eligible, and 56 (72.7%) randomized with 28 in each group', '56 women', 'Individuals']","['Daily Meditation Program', 'twice-daily application-based mindful meditation program', 'routine care or routine care plus an application-based twice-daily mindful meditation program', 'mindful meditation', 'routine care plus educational pamphlets (control arm) or routine care plus a twice-daily application-based mindful meditation program (intervention arm', 'mindful meditation programs']","['rate of abnormal STAI scores', 'maternal state anxiety level (measured by the validated State Trait Anxiety Inventory, STAI', 'mean score of STAI anxiety level', 'anxiety levels', 'maternal anxiety', 'positive experience', 'anxiety score', 'stress (measured by Perceived Stress Scale, PSS) and depression (measured by Edinburgh Depression Scale, EDS) on day 4, latency period from randomization to delivery, patient experience, number of meditation sessions, and total meditation time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023103', 'cui_str': 'Latency Period (Psychology)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",56.0,0.0620585,"A decreased anxiety score from day 1 to day 4 was seen in both the control group (- 4.7) and the meditation group (- 9.4, p=0.12).","[{'ForeName': 'Morgen S', 'Initials': 'MS', 'LastName': 'Doty', 'Affiliation': 'Obstetrix Maternal-Fetal Medicine Specialists of Houston, Houston, TX (Dr Doty). Electronic address: msdoty@gmail.com.'}, {'ForeName': 'Han-Yang', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}, {'ForeName': 'Oluwadare', 'Initials': 'O', 'LastName': 'Ajishegiri', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100562']
1031,35018789,Could the High-Power Laser Increase the Efficacy of Stone Lithotripsy During Retrograde Intrarenal Surgery?,"Objective:  To compare a high-power setting in holmium: yttrium-aluminum-garnet laser lithotripsy with the established low-power setting approach during retrograde intrarenal surgery (RIRS).  Materials and Methods:  Our study analyzed the data of consecutive patients managed with RIRS. The patients were divided into two groups according to the employed laser settings of power, energy, and frequency; dusting (20 W = 0.5 J × 40 Hz) (group 1) and stone self-popping (60 W = 1.5-2 J × 30-40 Hz) (group 2). Perioperative outcomes, including operative time (OT) and stone disintegration time (SDT), were compared between groups. The stone-free rate (SFR) was evaluated 1 month after the surgery.  Results:  Overall, 174 patients with 179 renal units were included. The dusting mode was utilized in 98 patients (100 renal units), whereas 76 patients (79 renal units) underwent the stone self-popping technique. The SFR was 82.1% for both groups. The OT and SDT were 60.1 ± 18.6 and 32.6 ± 9.4 minutes, respectively, for group 1 and 44.9 ± 15.5 and 16.5 ± 4.7 minutes, respectively, for group 2. According to the final analysis, laser lithotripsy using the stone self-popping technique was significantly faster compared with the dusting technique with coefficient values of 14.12 minutes (95% confidence interval [CI] = 8.8-19.44) and 15.84 minutes (95% CI = 13.44-18.2) for OT and SDT, respectively.  Conclusions:  The stone self-popping technique with power at 60 W, frequency at 30 to 40 Hz, and energy at 1.5 to 2.0 J is a safe and effective modality for active treatment of renal stones. In comparison with the dusting mode, it resulted in significantly faster procedures (14.12 minutes) with similar SFRs.",2022,"According to the final analysis, laser lithotripsy using stone the ""self-popping"" technique was significantly faster compared to the dusting technique with a coefficient value of 14.12min (CI = 8.8 - 19.44) and 15.84min (CI = 13.44 - 18.2) for OT and SDT, respectively.
","['98 patients (100 renal units), whereas 76 patients (79 renal units) underwent the', 'consecutive patients managed with RIRS', '174 patients with 179 renal units were included']","['holmium yttrium aluminum garnet (Ho:YAG) laser lithotripsy', 'stone ""self-popping"" technique', 'stone lithotripsy', 'employed laser settings of power, energy and frequency; dusting (20W=0.5Jx40Hz) (Group1) and stone ""self-popping"" (60W=1.5-2Jx30-40Hz']","['operative time (OT) and stone disintegration time (SDT', 'Stone-free rate (SFR', 'SFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013330', 'cui_str': 'Dust'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",174.0,0.0262959,"According to the final analysis, laser lithotripsy using stone the ""self-popping"" technique was significantly faster compared to the dusting technique with a coefficient value of 14.12min (CI = 8.8 - 19.44) and 15.84min (CI = 13.44 - 18.2) for OT and SDT, respectively.
","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Tsaturyan', 'Affiliation': 'Department of Urology, University of Patras, Patras, Greece.'}, {'ForeName': 'Begona', 'Initials': 'B', 'LastName': 'Ballesta Martinez', 'Affiliation': 'Department of Urology, University of Patras, Patras, Greece.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lattarulo', 'Affiliation': 'Department of Urology, University of Patras, Patras, Greece.'}, {'ForeName': 'Constatinos', 'Initials': 'C', 'LastName': 'Adamou', 'Affiliation': 'Department of Urology, University of Patras, Patras, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Pagonis', 'Affiliation': 'Department of Urology, University of Patras, Patras, Greece.'}, {'ForeName': 'Angelis', 'Initials': 'A', 'LastName': 'Peteinaris', 'Affiliation': 'Department of Urology, University of Patras, Patras, Greece.'}, {'ForeName': 'Despoina', 'Initials': 'D', 'LastName': 'Liourdi', 'Affiliation': 'Department of Urology, University of Patras, Patras, Greece.'}, {'ForeName': 'Theofanis', 'Initials': 'T', 'LastName': 'Vrettos', 'Affiliation': 'Department of Anesthesiology and ICU, University of Patras, Patras, Greece.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Liatsikos', 'Affiliation': 'Department of Urology, University of Patras, Patras, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Kallidonis', 'Affiliation': 'Department of Urology, University of Patras, Patras, Greece.'}]",Journal of endourology,['10.1089/end.2021.0870']
1032,35018671,Comparison of hematopoietic progenitor cell collection using different inlet flow rates with the Fenwal Amicus.,"PURPOSE


We have used a hematopoietic progenitor cell (HPC) algorithm (standard [STD]) that restricted the inlet flow rate to 65 mL/min for peripheral white blood cell count (PWBC) >35 × 10 9  /L (STD). In this study, we evaluated a technique that allows 85 mL/min, regardless of the PWBC count (high). For patients with PWBC >35 × 10 9  /L, a prospective, randomized comparison of the high flow rate vs the STD PWBC-based flow rate (65 mL/min) was performed, comparing CD34+ and lymphocyte yields, collection efficiencies (CE1), mononuclear cells (MNC), and granulocytes, red blood cell (RBC), and platelet content.
METHODS


The Fenwal Amicus version 4.5 with a heparinized ACD-A anticoagulant (AC) delivered at a 26:1 AC ratio was used. Paired comparisons between high and STD techniques were assessed with Wilcoxon signed rank tests, with P < .05 considered significant. Data are summarized as medians.
RESULTS


Forty patient pairs (autologous) were compared. Diagnoses included primarily multiple myeloma (60%) and lymphoma (37.5%). High had significantly higher median average inlet rates (69 vs 55 mL/min), whole blood processed (20 vs 16 L), and cycles (15 vs 14) than STD. There were no significant differences in pre-procedure counts. Collection contents were (high/STD): 306/328 × 10 6  CD34+ cells, 48/59% CD34+ CE1 (significant), 0.2/0.2 × 10 9  /kg lymphocytes, 45/57% lymphocyte CE1, 63/59 × 10 9  WBC, 15/16 × 10 9  granulocytes, and 1.9/1.7 × 10 11  platelets.
CONCLUSIONS


The simpler, standardized high flow technique did not significantly increase or decrease CD34+ cells or lymphocyte yields, but did significantly decrease CD34+ CE1. The effects on cross-cellular content were minimal and not clinically significant.",2022,"The simpler, standardized high flow technique did not significantly increase or decrease CD34+ cells or lymphocyte yields, but did significantly decrease CD34+ CE1.",['patients with PWBC '],"['heparinized ACD-A anticoagulant (AC', 'hematopoietic progenitor cell collection', 'hematopoietic progenitor cell (HPC) algorithm (standard [STD']","['CD34+ CE1', 'CD34+ and lymphocyte yields, collection efficiencies (CE1), mononuclear cells (MNC), and granulocytes, red blood cell (RBC), and platelet content', 'Collection contents', 'median average inlet rates', 'decrease CD34+ cells or lymphocyte yields']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]","[{'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}]","[{'cui': 'C0054953', 'cui_str': 'Lymphocyte antigen CD34'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3179046', 'cui_str': 'Inlets'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}]",,0.0430458,"The simpler, standardized high flow technique did not significantly increase or decrease CD34+ cells or lymphocyte yields, but did significantly decrease CD34+ CE1.","[{'ForeName': 'Edwin A', 'Initials': 'EA', 'LastName': 'Burgstaler', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Division of Transfusion Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Bryant', 'Affiliation': 'Clinical Trials and Biostatistics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Winters', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Division of Transfusion Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}]",Journal of clinical apheresis,['10.1002/jca.21959']
1033,35023547,Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.,"AIMS


The complementary studies FIDELIO-DKD and FIGARO-DKD in patients with type 2 diabetes and chronic kidney disease (CKD) examined cardiovascular and kidney outcomes in different, overlapping stages of CKD. The purpose of the FIDELITY analysis was to perform an individual patient-level prespecified pooled efficacy and safety analysis across a broad spectrum of CKD to provide more robust estimates of safety and efficacy of finerenone compared with placebo.
METHODS AND RESULTS


For this prespecified analysis, two phase III, multicentre, double-blind trials involving patients with CKD and type 2 diabetes, randomized 1:1 to finerenone or placebo, were combined. Main time-to-event efficacy outcomes were a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure, and a composite of kidney failure, a sustained ≥57% decrease in estimated glomerular filtration rate from baseline over ≥4 weeks, or renal death. Among 13 026 patients with a median follow-up of 3.0 years (interquartile range 2.3-3.8 years), the composite cardiovascular outcome occurred in 825 (12.7%) patients receiving finerenone and 939 (14.4%) receiving placebo [hazard ratio (HR), 0.86; 95% confidence interval (CI), 0.78-0.95; P = 0.0018]. The composite kidney outcome occurred in 360 (5.5%) patients receiving finerenone and 465 (7.1%) receiving placebo (HR, 0.77; 95% CI, 0.67-0.88; P = 0.0002). Overall safety outcomes were generally similar between treatment arms. Hyperkalaemia leading to permanent treatment discontinuation occurred more frequently in patients receiving finerenone (1.7%) than placebo (0.6%).
CONCLUSION


Finerenone reduced the risk of clinically important cardiovascular and kidney outcomes vs. placebo across the spectrum of CKD in patients with type 2 diabetes.
KEY QUESTION


Does finerenone, a novel selective, nonsteroidal mineralocorticoid receptor antagonist, added to maximum tolerated renin-angiotensin system inhibition reduce cardiovascular disease and kidney disease progression over a broad range of chronic kidney disease in patients with type 2 diabetes?
KEY FINDING


In a prespecified, pooled individual-level analysis from two randomized trials, we found reductions both in cardiovascular events and kidney failure outcomes with finerenone. Because 40% of the patients had an estimated glomerular filtration rate of >60 mL/min/1.73m2 they were identified solely on the basis of albuminuria.
TAKE HOME MESSAGE


Finerenone reduces the risk of clinical cardiovascular outcomes and kidney disease progression in a broad range of patients with chronic kidney disease and type 2 diabetes. Screening for albuminuria to identify at-risk patients among patients with type 2 diabetes facilitates reduction of both cardiovascular and kidney disease burden.",2022,"Hyperkalaemia leading to permanent treatment discontinuation occurred more frequently in patients receiving finerenone (1.7%) than placebo (0.6%).
","['patients with CKD and type 2 diabetes', 'patients with type 2 diabetes', '13 026 patients with a median follow-up of 3.0 years (interquartile range 2.3-3.8 years', 'patients with type 2 diabetes and chronic kidney disease', 'patients with chronic kidney disease and type 2 diabetes', 'patients with type 2 diabetes and chronic kidney disease (CKD']","['placebo', 'finerenone or placebo', 'finerenone']","['Overall safety outcomes', 'cardiovascular events and kidney failure outcomes', 'composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure, and a composite of kidney failure', 'composite cardiovascular outcome', 'glomerular filtration rate', 'Cardiovascular and kidney outcomes', 'Hyperkalaemia', 'estimated glomerular filtration rate from baseline over ≥4\u2009weeks, or renal death', 'risk of clinical cardiovascular outcomes and kidney disease progression', 'composite kidney outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4045511', 'cui_str': 'finerenone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",13026.0,0.284994,"Hyperkalaemia leading to permanent treatment discontinuation occurred more frequently in patients receiving finerenone (1.7%) than placebo (0.6%).
","[{'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Indiana University School of Medicine and Richard L. Roudebush VA Medical Center, 1481 W. 10th St, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, Attikon University Hospital, Rimini 1, Chaidari 124 62, Athens, Greece.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, 1500 E. Medical Centre Dr #6303, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, CharitéUniversitätsmedizin, Charitépl. 1, 10117 Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels SteensensVej 2-4, 2820 Gentofte, Denmark.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Cardiology and Nephrology Clinical Development, Bayer AG, Müllerstraße 178, 13353 Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kolkhof', 'Affiliation': 'Research and Development, Preclinical Research Cardiovascular, Bayer AG, Friedrich-Ebert-Straße 217/333, 42117, Wuppertal, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nowack', 'Affiliation': 'Research and Development, Clinical Development Operations, Bayer AG, Friedrich-Ebert-Straße 217/333, 42117, Wuppertal, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gebel', 'Affiliation': 'Research and Development, Integrated Analysis Statistics, Bayer AG, Friedrich-Ebert-Straße 217/333, 42117, Wuppertal, Germany.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': 'Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Instituto de Investigación Hospital 12 de OctubreCentro de ActividadesAmbulatorias, 6ª Planta Bloque DAvda. de Córdoba, s/n28041 Madrid, Spain.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago Medicine, 5841 South Maryland Avenue, MC 6092, 60637 Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehab777']
1034,34922353,Alirocumab after acute coronary syndrome in patients with a history of heart failure.,"AIMS


Patients with heart failure (HF) have not been shown to benefit from statins. In a post hoc analysis, we evaluated outcomes in ODYSSEY OUTCOMES in patients with vs. without a history of HF randomized to the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab or placebo.
METHODS AND RESULTS


Among 18 924 patients with recent acute coronary syndrome (ACS) receiving intensive or maximum-tolerated statin treatment, the primary outcome of major adverse cardiovascular events (MACE) was compared in patients with or without a history of HF. The pre-specified secondary outcome of hospitalization for HF was also analysed. Overall, 2815 (14.9%) patients had a history of HF. Alirocumab reduced low-density lipoprotein cholesterol and lipoprotein(a) similarly in patients with or without HF. Overall, alirocumab reduced MACE compared with placebo [hazard ratio (HR): 0.85; 95% confidence interval (CI): 0.78-0.93; P = 0.0001]. This effect was observed among patients without a history of HF (HR: 0.78; 95% CI: 0.70-0.86; P < 0.0001), but not in those with a history of HF (HR: 1.17; 95% CI: 0.97-1.40; P = 0.10) (Pinteraction = 0.0001). Alirocumab did not reduce hospitalization for HF, overall or in patients with or without prior HF.
CONCLUSION


Alirocumab reduced MACE in patients without a history of HF but not in patients with a history of HF. Alirocumab did not reduce hospitalizations for HF in either group. Patients with a history of HF are a high-risk group that does not appear to benefit from PCSK9 inhibition after ACS.",2022,"Overall, alirocumab reduced MACE compared with placebo [hazard ratio (HR): 0.85; 95% confidence interval (CI): 0.78-0.93; P = 0.0001].","['patients with or without HF', 'patients with a history of heart failure', 'Patients with a history of HF are a high-risk group', 'patients with recent acute coronary syndrome (ACS', 'Patients with heart failure (HF', '18 924 patients with recent acute coronary syndrome (ACS) receiving intensive or maximum-tolerated statin treatment, the primary outcome of']","['placebo', 'alirocumab reduced MACE', 'proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab or placebo', 'Alirocumab', 'Alirocumab reduced MACE']","['major adverse cardiovascular events (MACE', 'low-density lipoprotein cholesterol', 'adverse cardiovascular events (MACE', 'low-density lipoprotein cholesterol and lipoprotein(a', 'hospitalization for HF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",18924.0,0.17672,"Overall, alirocumab reduced MACE compared with placebo [hazard ratio (HR): 0.85; 95% confidence interval (CI): 0.78-0.93; P = 0.0001].","[{'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, 5 Park Road, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, B130, Aurora, CO 80045, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'Department of Epidemiology and Biostatistics, State University of New York, Downstate School of Public Health, 450 Clarkson Avenue, MS 43, Brooklyn, NY 11203, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, 701 19th Street South-LHRB 310, Birmingham, AL 35294, USA.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center, Taipei Veterans General Hospital and Taiwan School of Medicine, National Yang-Ming University, 201, Sec. 2, Shih-Pai road, Taipei, Taiwan.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clınicos Latino America, Instituto Cardiovascular de Rosario, Paraguay 160, Santa Fe, Rosario 2000, Argentina.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, 87 Ave NW, Edmonton, Alberta T6G 2E1, Canada.'}, {'ForeName': 'Johan Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden 2333 ZA, the Netherlands.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Loy', 'Affiliation': 'Sanofi, 55 Corporate Dr, Bridgewater, NJ 08807, USA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University, School of Medicine, 300 W. Morgan St., NC 27701, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, 777 Old Saw Mill River Rd, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Arsen D', 'Initials': 'AD', 'LastName': 'Ristić', 'Affiliation': 'Department of Cardiology, University Clinical Center of Serbia, Belgrade University School of Medicine, 8 Dr Subotića Street, Belgrade.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Theodor-Stern-Kai 7, Frankfurt am Main 60590, Germany.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Duke University, School of Medicine, 300 W. Morgan St., NC 27701, USA.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, 46 Rue Henri Huchard, Paris, 75018 France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehab804']
1035,35026861,Efficacy of brinzolamide in the initial management of acute primary angle closure: A randomized controlled trial.,"WHAT IS KNOWN AND OBJECTIVE?: Since comprehensive medication has an important role in the initial management of patients presenting with acute primary angle closure, it is necessary to analyse the effect of each drug on alleviating the disease. This study aimed to evaluate the intraocular pressure-lowering effect of brinzolamide in the sequential treatment of acute primary angle closure. METHODS: In this randomized double-blind controlled trial, a total of 131 eyes of 125 consecutive patients who presented with their first episode of acute primary angle closure were recruited and received sequential treatment. In this treatment, in the absence of remission, anti-glaucoma drugs, anterior chamber paracentesis and argon laser peripheral iridoplasty are used sequentially. The patients were randomized to receive either brinzolamide or normal saline as a placebo. The primary outcomes were decreased intraocular pressure, success rate and treatment time. RESULTS AND DISCUSSION: There was no statistically significant difference in the decreased level of intraocular pressure between the two groups at 6, 12 or 24 h after the start of treatment (p-values were 0.526, 0.206 and 0.130 respectively). The success rate and treatment time were also not significantly different between the groups. No adverse side effects of brinzolamide were observed in the brinzolamide group. WHAT IS NEW AND CONCLUSION?: In patients with a first episode of acute primary angle closure, brinzolamide did not improve the effectiveness of the sequential treatment for reducing the intraocular pressure levels or shortening the treatment time within the first 24 h of initiating therapy.",2022,"There was no statistically significant difference in the decreased level of intraocular pressure between the two groups at 6, 12 or 24 h after the start of treatment (p-values were 0.526, 0.206 and 0.130 respectively).","['patients presenting with acute primary angle closure', '131 eyes of 125 consecutive patients who presented with their first episode of acute primary angle closure', 'patients with a first episode of acute primary angle closure', 'acute primary angle closure']","['brinzolamide', 'brinzolamide or normal saline as a placebo']","['level of intraocular pressure', 'adverse side effects of brinzolamide', 'intraocular pressure levels', 'success rate and treatment time', 'intraocular pressure, success rate and treatment time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439615', 'cui_str': 'First episode'}]","[{'cui': 'C0673966', 'cui_str': 'brinzolamide'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0673966', 'cui_str': 'brinzolamide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",125.0,0.124243,"There was no statistically significant difference in the decreased level of intraocular pressure between the two groups at 6, 12 or 24 h after the start of treatment (p-values were 0.526, 0.206 and 0.130 respectively).","[{'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of ophthalmology, Affiliated Hospital of Hebei University, Baoding, China.'}, {'ForeName': 'Xinming', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of ophthalmology, Affiliated Hospital of Hebei University, Baoding, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of ophthalmology, Affiliated Hospital of Hebei University, Baoding, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of ophthalmology, Affiliated Hospital of Hebei University, Baoding, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of ophthalmology, Affiliated Hospital of Hebei University, Baoding, China.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13609']
1036,35029691,Improvements in cognitive function and quantitative sleep electroencephalogram in obstructive sleep apnea after six months of continuous positive airway pressure treatment.,"STUDY OBJECTIVES


Untreated obstructive sleep apnea (OSA) is associated with cognitive deficits and altered brain electrophysiology. We evaluated the effect of continuous positive airway pressure (CPAP) treatment on quantitative sleep electroencephalogram (EEG) measures and cognitive function.
METHODS


We studied 167 patients with OSA (age 50 ± 13, AHI 35.0 ± 26.8) before and after 6 months of CPAP. Cognitive tests assessed working memory, sustained attention, visuospatial scanning, and executive function. All participants underwent overnight polysomnography at baseline and after CPAP. Power spectral analysis was performed on EEG data (C3-M2) in a sub-set of 90 participants. Relative delta EEG power and sigma power in NREM and EEG slowing in REM were calculated. Spindle densities (events/min) in N2 were also derived using automated spindle event detection. All outcomes were analysed as change from baseline.
RESULTS


Cognitive function across all cognitive domains improved after six months of CPAP. In our sub-set, increased relative delta power (p < .0001) and reduced sigma power (p = .001) during NREM were observed after the 6-month treatment period. Overall, fast and slow sleep spindle densities during N2 were increased after treatment.
CONCLUSIONS


Cognitive performance was improved and sleep EEG features were enhanced when assessing the effects of CPAP. These findings suggest the reversibility of cognitive deficits and altered brain electrophysiology observed in untreated OSA following six months of treatment.",2022,"In our sub-set, increased relative delta power (p<0.0001) and reduced sigma power (p=0.001) during NREM were observed after the 6-month treatment period.","['162 OSA patients (age 50±13, AHI 35.0±26.8) before and after 6 months of CPAP', 'Untreated obstructive sleep apnea (OSA']",['continuous positive airway pressure (CPAP'],"['reversibility of cognitive deficits and altered brain electrophysiology', 'Overall, fast and slow sleep spindle densities', 'quantitative sleep electroencephalogram (EEG) measures and cognitive function', 'Relative delta EEG power and sigma power in NREM and EEG slowing in REM', 'relative delta power', 'reduced sigma power', 'Cognitive Function and Quantitative Sleep EEG', 'Cognitive tests assessed working memory, sustained attention, visuospatial scanning and executive function', 'sleep EEG features']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0449261', 'cui_str': 'Reversibility'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0200101', 'cui_str': 'Sleep electroencephalogram'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",162.0,0.0379083,"In our sub-set, increased relative delta power (p<0.0001) and reduced sigma power (p=0.001) during NREM were observed after the 6-month treatment period.","[{'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': ""D'Rozario"", 'Affiliation': 'Faculty of Science, School of Psychology, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Faculty of Science, School of Psychology, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Keith K H', 'Initials': 'KKH', 'LastName': 'Wong', 'Affiliation': 'Sleep and Circadian Research Group, Woolcock Institute of Medical Research, University of Sydney, Glebe, New South Wales, Australia.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Unger', 'Affiliation': 'Sleep and Circadian Research Group, Woolcock Institute of Medical Research, University of Sydney, Glebe, New South Wales, Australia.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Sleep and Circadian Research Group, Woolcock Institute of Medical Research, University of Sydney, Glebe, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vakulin', 'Affiliation': 'Adelaide Institute for Sleep Health/FHMRI Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Chien-Hui', 'Initials': 'CH', 'LastName': 'Kao', 'Affiliation': 'Healthy Brain Ageing Program, Brain and Mind Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Naismith', 'Affiliation': 'Faculty of Science, School of Psychology, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Sleep and Circadian Research Group, Woolcock Institute of Medical Research, University of Sydney, Glebe, New South Wales, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Sleep and Circadian Research Group, Woolcock Institute of Medical Research, University of Sydney, Glebe, New South Wales, Australia.'}]",Sleep,['10.1093/sleep/zsac013']
1037,35038015,Application of a 3D-printed eye model for teaching direct ophthalmoscopy to undergraduates.,"PURPOSE


This study aims to design an eye model that can simulate the fundus for teaching direct ophthalmoscopy and to evaluate its effectiveness.
METHODS


We first used 3D printing materials to make an eye model and then randomly assigned 92 undergraduates into group A (model-assisted training group) and group B (traditional training group) to test our model. After the same training time, real patients were used to test the students, with 120 s as the examination time limit. We recorded the students' ability to clearly see the optic disk, the time to determine the cup-to-disk ratio, and whether they were correct.
RESULTS


Forty-three students in group A (93.48%) successfully saw the fundus, while 21 in group B (45.65%) succeeded. The difference between the two groups was 47.83% (95% confidence interval, 29.59-66.07%, P < 0.0001). The median time to see the fundus was 29s (95% confidence interval 23-45 s) in group A, while an estimated minimum time in group B was 80 s, indicating that group A was significantly faster than group B (P < 0.0001).
CONCLUSIONS


This 3D-printed eye model significantly improved the students' study interest, study efficiency, and study results and is worthy of being promoted.",2022,"The median time to see the fundus was 29s (95% confidence interval 23-45 s) in group A, while an estimated minimum time in group B was 80 s, indicating that group A was significantly faster than group B (P < 0.0001).
",['teaching direct ophthalmoscopy to undergraduates'],['92 undergraduates into group A (model-assisted training group) and group B (traditional training group) to test our model'],['median time to see the fundus'],"[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1444581', 'cui_str': 'Direct ophthalmoscopy'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}]",92.0,0.0195754,"The median time to see the fundus was 29s (95% confidence interval 23-45 s) in group A, while an estimated minimum time in group B was 80 s, indicating that group A was significantly faster than group B (P < 0.0001).
","[{'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Mingyue', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yutong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Rongping', 'Initials': 'R', 'LastName': 'Dai', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Meifen', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Youxin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China. chenyx@pumch.cn.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-021-05538-w']
1038,35022796,Effects of Marijuana Use on Smokers Switching to E-Cigarettes in a Randomized Clinical Trial.,"INTRODUCTION


Co-use of tobacco and marijuana is common, and research suggests that marijuana use may be a barrier to smoking cessation. Research to date has not evaluated how marijuana use affects e-cigarette switching behaviors and related outcomes in a harm reduction trial.
AIMS AND METHODS


This secondary analysis includes African American (48%) and Latinx (52%) adult smokers randomized to the e-cigarette group (N = 114) of a harm reduction clinical trial from 2018 to 2019. Participants were provided JUUL e-cigarettes and encouraged to make an exclusive switch for 6 weeks. Our primary outcome was cigarettes smoked per week. Secondary health outcomes were e-cigarette substitution (calculated by measuring e-cigarette pod use), expired carbon monoxide (CO), and respiratory symptoms. Marijuana products were recorded at three timepoints and coded for combustion.
RESULTS


Marijuana use during the study (n = 52, 46%) was not associated with week 6 cigarettes smoked or e-cigarette substitution, and combustible marijuana use was not associated with week 6 respiratory symptoms (ps > .05). After controlling for cigarettes smoked at week 6, combustible marijuana use was significantly associated with a 4.4 ppm increase in CO compared with no use of marijuana (p = .001).
CONCLUSIONS


Marijuana use was not a barrier to switching to e-cigarettes in this 6-week trial. Marijuana use contributed to elevated CO, reflecting greater exposure to toxic combustion products, beyond the effects of cigarette smoking. Marijuana co-use may increase risk of adverse health outcomes and may be a confounding factor when using CO as an endpoint to bioverify exclusive e-cigarette use.
IMPLICATIONS


This is the first known study to examine the effects of marijuana use on smokers switching to e-cigarettes. Marijuana use was not a barrier to cigarette reduction in a 6-week randomized clinical trial. Marijuana use uniquely contributed to higher carbon monoxide among cigarette smokers, indicating greater exposure to toxic combustion products, which could increase risk of adverse health outcomes. Furthermore, combustible marijuana use may be a confounding factor when CO is used as an endpoint to bioverify exclusive e-cigarette use.",2022,"Marijuana use contributed to elevated CO, reflecting greater exposure to toxic combustion products, beyond the effects of cigarette smoking.","['cigarette smokers', 'African American (48%) and Latinx (52%) adult smokers randomized to the e-cigarette group (N=114) of a harm reduction clinical trial from 2018-2019', 'Smokers Switching to E-cigarettes']",['Marijuana Use'],"['e-cigarette substitution (calculated by measuring e-cigarette pod use), expired carbon monoxide (CO), and respiratory symptoms', 'carbon monoxide (CO', 'CO']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0679771', 'cui_str': 'Harm Minimization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}]",,0.0426594,"Marijuana use contributed to elevated CO, reflecting greater exposure to toxic combustion products, beyond the effects of cigarette smoking.","[{'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Rice', 'Affiliation': 'Neuroscience Interdepartmental Graduate Program, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': 'Department of Population Health and the University of Kansas Cancer Center, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Behavioral and Social Sciences and the Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Benowitz', 'Affiliation': 'Program in Clinical Pharmacology, Division of Cardiology, Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Woodcock', 'Affiliation': 'Department of Psychology, California State University San Marcos, San Marcos, CA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Pulvers', 'Affiliation': 'Department of Psychology, California State University San Marcos, San Marcos, CA, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntac008']
1039,34861767,Immunologic Change over 72 Weeks Following Raltegravir- Versus Efavirenz-Based Therapy in HIV/HCV-Coinfected Individuals in Vietnam.,"The impact of HIV antiretroviral therapy (ART) on immune dysregulation associated with hepatitis C virus (HCV)/HIV coinfection is incompletely understood. We serially assessed monocyte activation (neopterin, sCD14, and sCD163) and T cell activation (HLA-DR, CD38) and immune exhaustion [program cell death protein 1 (PD1), TIGIT] in HIV/HCV-coinfected individuals who participated in a randomized trial performed in Vietnam designed to assess the hepatotoxicity of raltegravir (RAL)- versus efavirenz (EFV)-based therapy when used as first-time ART in combination with tenofovir disoproxil fumarate and emtricitabine. Baseline pre-ART values were compared with those from ART-naive HIV-monoinfected and HIV-seronegative individuals. Before ART, HIV/HCV-coinfected individuals had higher levels of neopterin, sCD14, and sCD163, and increased frequencies of CD38 + HLA-DR + , PD1 + , and TIGIT +  CD4 and CD8 T cells compared with ART-naive HIV-monoinfected or HIV-seronegative individuals (all  p  < .01). Most parameters did not normalize despite 72 weeks of ART. In particular sCD163 persisted at high levels. Improvement over 72 weeks in fibrosis as assessed by FibroScan ®  correlated with reductions in plasma sCD163 and in the frequencies of T cell activation, single PD1 + , TIGIT + , and dual PD1 + TIGIT +  CD8 T cells. A nonsignificant tendency toward more favorable effects on monocyte and T cell immune activation and on T cell exhaustion were seen with RAL-compared with EFV-based therapy. The initiation of ART in HIV/HCV-coinfected individuals is associated with incomplete improvement in monocyte and T cell immune activation and exhaustion, which was associated with some corresponding improvement in liver fibrosis.",2022,"Improvement over 72 weeks in fibrosis as assessed by FibroScan ®  correlated with reductions in plasma sCD163 and in the frequencies of T cell activation, single PD1 + , TIGIT + , and dual PD1 + TIGIT +  CD8 T cells.",['HIV/HCV-Coinfected Individuals in Vietnam'],"['tenofovir disoproxil fumarate and emtricitabine', 'Efavirenz-Based Therapy', 'raltegravir (RAL)- versus efavirenz (EFV)-based therapy', 'Raltegravir', 'HIV antiretroviral therapy (ART']","['frequencies of T cell activation, single PD1 + , TIGIT + , and dual PD1 + TIGIT +  CD8 T cells', 'Immunologic Change', 'plasma sCD163', 'monocyte and T cell immune activation and on T cell exhaustion', 'monocyte activation (neopterin, sCD14, and sCD163) and T cell activation (HLA-DR, CD38) and immune exhaustion [program cell death protein 1 (PD1), TIGIT', 'neopterin, sCD14, and sCD163, and increased frequencies of CD38 + HLA-DR + , PD1 + , and TIGIT +  CD4 and CD8 T cells']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C2607657', 'cui_str': 'TIGIT protein, human'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR antigen'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0135710', 'cui_str': 'PDCD1 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}]",,0.128366,"Improvement over 72 weeks in fibrosis as assessed by FibroScan ®  correlated with reductions in plasma sCD163 and in the frequencies of T cell activation, single PD1 + , TIGIT + , and dual PD1 + TIGIT +  CD8 T cells.","[{'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Shikuma', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Le', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}, {'ForeName': 'Thao Vu', 'Initials': 'TV', 'LastName': 'Phuong', 'Affiliation': 'Department of Medicine, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Glen M', 'Initials': 'GM', 'LastName': 'Chew', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}, {'ForeName': 'Van Vinh Chau', 'Initials': 'VVC', 'LastName': 'Nguyen', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Trieu Ly', 'Initials': 'TL', 'LastName': 'Vo', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Chathura', 'Initials': 'C', 'LastName': 'Siriwardhana', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Chow', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}, {'ForeName': 'Hayk', 'Initials': 'H', 'LastName': 'Ghukasyan', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}, {'ForeName': 'Nath', 'Initials': 'N', 'LastName': 'Limpruttidham', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Premeaux', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}, {'ForeName': 'Louie Mar', 'Initials': 'LM', 'LastName': 'Gangcuangco', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Department of Psychological Sciences, Missouri Institute of Mental Health, University of Missouri-St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Lishomwa C', 'Initials': 'LC', 'LastName': 'Ndhlovu', 'Affiliation': 'Hawaii Center for AIDS, Department of Medicine, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii, USA.'}]",AIDS research and human retroviruses,['10.1089/AID.2021.0076']
1040,35026342,"A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis.","BACKGROUND


Vunakizumab (SHR-1314) is a novel interleukin 17A monoclonal antibody that has shown preliminary efficacy and tolerability in phase I trials.
OBJECTIVE


To evaluate the efficacy and safety of vunakizumab in moderate-to-severe plaque psoriasis.
METHODS


In this 36-week, multicenter, double-blinded, phase II study (NCT03463187), 187 eligible patients with moderate-to-severe plaque psoriasis were randomized 1:1:1:1:1 to receive vunakizumab (40, 80, 160, or 240 mg) or placebo subcutaneously, every 4 weeks, until week 12 (2 more drug administrations for the vunakizumab groups on weeks 16 and 20). The primary end point was at least 75% improvement in the Psoriasis Area and Severity Index at week 12.
RESULTS


At week 12, there were significantly greater proportions of responders with at least 75% improvement in the Psoriasis Area and Severity Index in all vunakizumab groups compared to placebo (40, 80, 160, and 240 mg: 56.8%, 65.8%, 81.6%, and 86.5%, respectively, vs 5.4%; P < .001 for all); the proportions of patients achieving Physician's Global Assessment responses of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, and 73.0%, respectively, vs 8.1%). No unexpected adverse effects were observed.
LIMITATIONS


The study was relatively short in duration and included no active control.
CONCLUSION


Vunakizumab showed promising efficacy for moderate-to-severe plaque psoriasis, with good tolerability, warranting further investigation in larger and longer-term studies.",2022,"At week 12, there were significantly greater proportions of PASI 75 responders in all vunakizumab groups compared to placebo (40, 80, 160, 240 mg: 56.8%, 65.8%, 81.6%, 86.5% vs 5.4%; all P < .001); the proportions of patients achieving physician's global assessment response of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, 73.0% vs 8.1%).","['187 eligible patients with moderate-to-severe plaque psoriasis', 'Patients with Moderate-to-Severe Plaque Psoriasis']","['placebo', 'vunakizumab', 'Vunakizumab (SHR-1314', 'Placebo', 'Vunakizumab']","['psoriasis area and severity index', ""proportions of patients achieving physician's global assessment response"", 'adverse effects', 'efficacy and safety']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1439030', 'cui_str': 'SHORT ROOT protein, Arabidopsis'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",187.0,0.247221,"At week 12, there were significantly greater proportions of PASI 75 responders in all vunakizumab groups compared to placebo (40, 80, 160, 240 mg: 56.8%, 65.8%, 81.6%, 86.5% vs 5.4%; all P < .001); the proportions of patients achieving physician's global assessment response of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, 73.0% vs 8.1%).","[{'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, Peking University Third Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Kexiang', 'Initials': 'K', 'LastName': 'Yan', 'Affiliation': ""Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Qingchun', 'Initials': 'Q', 'LastName': 'Diao', 'Affiliation': ""Department of Dermatology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': ""Department of Dermatology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hongzhong', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': ""Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Institute of Dermatology and Department of Dermatology, The First Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Dermatology, Xiangya Hospital, Central South University, Changsha, People's Republic of China.""}, {'ForeName': 'Tiechi', 'Initials': 'T', 'LastName': 'Lei', 'Affiliation': ""Department of Dermatology, Renmin Hospital of Wuhan University/Hubei General Hospital, Wuhan, People's Republic of China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Dermatology, Changhai Hospital of Shanghai, Shanghai, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Dermatology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, People's Republic of China.""}, {'ForeName': 'Xinghua', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Dermatology, The 1st Hospital of China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Sinclair', 'Affiliation': 'Sinclair Dermatology, East Melbourne, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai, People's Republic of China. Electronic address: xjhhsyy@163.com.""}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2022.01.005']
1041,35029306,"Exposure-response relationship of ramucirumab in RANGE, a randomized phase III trial in advanced urothelial carcinoma refractory to platinum therapy.","AIMS


Patients with advanced urothelial carcinoma (UC) who progress after platinum-based chemotherapy have a poor prognosis, and there is a medical need to improve current treatment options. Ramucirumab plus docetaxel significantly improved progression-free survival but not overall survival (OS) in platinum-refractory advanced UC (RANGE trial; NCT02426125). Here, we report the exposure-response (ER) of ramucirumab plus docetaxel using data from the RANGE trial.
METHODS


Pharmacokinetic (PK) samples were collected (cycle 1-3, 5, 9 [day 1] and 30 days from treatment discontinuation), and PK data were analysed using population PK (popPK) analysis. The minimum ramucirumab concentration after first dose administration (C min,1  , or trough concentration immediately prior to the second dose) was derived by popPK analysis and used as the exposure parameter for ER analysis. Cox proportional hazards regression models and matched case-control analyses were used to evaluate the relationship between C min,1  and OS. The C min,1  relationship with safety was assessed descriptively.
RESULTS


Several poor prognostic factors (ECOG 1, haemoglobin concentration <100 g/L, presence of liver metastases) appeared more frequently in the lower exposure quartiles, suggesting a possible disease-PK interaction. A significant association was identified between C min,1  and OS (P = .0108). Higher exposure quartiles were associated with longer survival and smaller hazard ratios compared to placebo. No new exposure-safety trends were observed within the exposure range (ramucirumab 10 mg/kg once every 3 weeks).
CONCLUSIONS


This prespecified ER analyses suggests a positive relationship between efficacy and ramucirumab exposure, with an imbalance associated with disease prognostic factors. Further investigation may elucidate a possible disease-PK relationship.",2022,"hemoglobin concentration <100 g/L, and presence of liver metastases) appeared more frequently in the lower exposure quartiles; suggesting a possible disease-PK interaction.","['advanced urothelial carcinoma refractory to platinum therapy', 'Patients with advanced urothelial carcinoma (UC) who progress after']","['ramucirumab plus docetaxel', 'Ramucirumab plus docetaxel', 'platinum-based chemotherapy', 'placebo']","['overall survival (OS', 'minimum ramucirumab concentration', 'hemoglobin concentration <100 g/L, and presence of liver metastases', 'longer survival and smaller hazard ratios', 'progression-free survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.145781,"hemoglobin concentration <100 g/L, and presence of liver metastases) appeared more frequently in the lower exposure quartiles; suggesting a possible disease-PK interaction.","[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Hospital 12 de Octubre, I + 12 Research Institute, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Vita-Salute San Raffaele University, IRCCS San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Jae-Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Centre, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Michiel S', 'Initials': 'MS', 'LastName': 'van der Heijden', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Fléchon', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, Sandra and Edward Meyer Cancer Center, New York, NY, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Drakaki', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Evan Y', 'Initials': 'EY', 'LastName': 'Yu', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Center, Seattle, WA, USA.'}, {'ForeName': 'Annamaria H', 'Initials': 'AH', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Walgren', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bell-McGuinn', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.15233']
1042,34902549,Child-Focused Cognitive Behavioral Therapy for Pediatric Abdominal Pain Disorders Reduces Caregiver Anxiety in Randomized Clinical Trial.,"Pediatric functional abdominal pain disorders (FAPD) are associated with elevated anxiety in youth and their caregivers, both contributing to an adverse impact on functioning in youth with FAPD. While a CBT approach (ie, Aim to Decrease Anxiety and Pain Treatment [ADAPT]) is known to improve health outcomes for youth, it is unknown if child-focused treatment improves caregiver anxiety. This secondary analysis of a larger randomized clinical trial examined if child-focused CBT (ADAPT) for pain and anxiety also impacts caregiver anxiety and explored the relation between caregiver anxiety and child symptoms (ie, pain, disability, anxiety) after treatment. A total of 79 caregiver-child dyads were randomized to ADAPT plus treatment as usual (TAU) or TAU only. Caregiver anxiety and child outcomes (pain, disability, anxiety) were assessed at baseline and approximately 8 weeks later. Caregivers of children who completed ADAPT+TAU demonstrated lower anxiety compared to those who only received TAU. Moreover, regardless of treatment assignment, caregivers with greater anxiety had children who reported more pain and anxiety, but not functional disability at post-assessment. Results suggest a brief, child-focused intervention targeting pain and anxiety may also improve caregiver anxiety. As such, suggestions to improve future treatments are offered. PERSPECTIVE: Caregiver anxiety symptoms diminished after their child with functional abdominal pain completed a course of child-focused CBT targeting pain and anxiety. Further, caregiver anxiety was related to child-reported symptoms (pain and anxiety) after treatment. Therefore, improved caregiver mental health via a child-focused CBT may also improve pediatric outcomes.",2022,A total of 79 caregiver-child dyads were randomized to ADAPT plus treatment as usual (TAU) or TAU only.,"['Pediatric functional abdominal pain disorders (FAPD', '79 caregiver-child dyads']","['ADAPT plus treatment as usual (TAU) or TAU only', 'Child-Focused Cognitive Behavioral Therapy', 'child-focused CBT (ADAPT']","['lower anxiety', 'pain and anxiety', 'Caregiver anxiety symptoms', 'caregiver anxiety and child symptoms (ie, pain, disability, anxiety', 'Caregiver anxiety and child outcomes (pain, disability, anxiety', 'caregiver anxiety']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",79.0,0.183979,A total of 79 caregiver-child dyads were randomized to ADAPT plus treatment as usual (TAU) or TAU only.,"[{'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Kalomiris', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Ely', 'Affiliation': 'Department of Family Medicine, Michigan State University, Grand Rapids, Michigan.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Love', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Constance A', 'Initials': 'CA', 'LastName': 'Mara', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Natoshia R', 'Initials': 'NR', 'LastName': 'Cunningham', 'Affiliation': 'Department of Family Medicine, Michigan State University, Grand Rapids, Michigan. Electronic address: Natoshia@msu.edu.'}]",The journal of pain,['10.1016/j.jpain.2021.12.001']
1043,34895775,Efficacy of a language-concordant health coaching intervention for latinx with diabetes.,"OBJECTIVE


To describe the effect of a language-concordant health coaching intervention for Spanish-speaking patients with limited English proficiency (LEP) and uncontrolled Type 2 Diabetes (T2D) on glycemic control, anxiety, depression, and diabetes self-efficacy.
METHODS


64 patients with T2D were randomly assigned to a control or intervention group. Outcomes were assessed by blood work and surveys pre and post intervention.
RESULTS


The mean sample age was 47.8 years (SD=11.3) and 81% were female. HbA1c was not significantly different between groups at baseline. The intervention group's HbA1c was significantly lower at times 2 and 3 than in the control arm (p < .01 and p < .001). There were significant reductions in the intervention group's mean HbA1c levels from baseline 10.37 to midpoint 9.20, p < .001; and from baseline 10.42 to study end 8.14, p < .001. Depression and anxiety scores significantly decreased (p < .05 and p < .001), and diabetes self-efficacy significantly increased (p < .001).
CONCLUSION


Health coaching led to statistically significant and clinically meaningful decreases in HbA1c, depression, and anxiety scores among LEP Latinx adults with uncontrolled T2D.
PRACTICE IMPLICATIONS


Heath coaching can be conducted in primary care clinics by nurses or advanced practice nurses. The short-term intervention tested here could be adapted to the clinical setting.",2022,The intervention group's HbA1c was significantly lower at times 2 and 3 than in the control arm (p < .01 and p < .001).,"['64 patients with T2D', 'latinx with diabetes', 'primary care clinics by nurses or advanced practice nurses', 'Spanish-speaking patients with limited English proficiency (LEP) and uncontrolled Type 2 Diabetes (T2D', 'The mean sample age was 47.8 years (SD=11.3) and 81% were female']","['language-concordant health coaching intervention', 'Health coaching', 'Heath coaching']","['diabetes self-efficacy', 'blood work and surveys pre and post intervention', 'glycemic control, anxiety, depression, and diabetes self-efficacy', 'Depression and anxiety scores', 'HbA1c, depression, and anxiety scores', 'mean HbA1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0870816', 'cui_str': 'Limited English Proficient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",64.0,0.0355065,The intervention group's HbA1c was significantly lower at times 2 and 3 than in the control arm (p < .01 and p < .001).,"[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Menon', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA. Electronic address: umenon@usf.edu.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Szalacha', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA; Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Glenn A', 'Initials': 'GA', 'LastName': 'Martinez', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Graham', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Pares-Avila', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA; College of Nursing, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Rechenberg', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Stauber', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ, USA.'}]",Patient education and counseling,['10.1016/j.pec.2021.11.024']
1044,35031861,Non-specific spondylodiscitis: a new perspective for surgical treatment.,"PURPOSE


Pyogenic spondylodiscitis is a relatively rare spinal disease; non-specific spondylodiscitis (NSS) cases are increasing. This study aims to identify if changes of inflammatory markers under antibiotic therapy can be used to determine which NSS patients can benefit from surgical indication earlier than others.
METHODS


Two groups of patients with NSS were examined. Group A underwent surgery, while Group B was treated conservatively. Group B was also subdivided in patients undergoing antibiotic therapy for > 6 weeks (B1) and < 6 weeks (B2). Groups were compared for age, gender, BMI, blood levels of ESR and CRP and VAS scale.
RESULTS


There were no differences (P = 0.06) in reduction in ESR at 4 weeks between two main groups. A reduction in CRP, with < 2.7 mg/dl at 4 weeks, was observed in Group A (P = 0.01). Comparing Group B1 to B2, a reduction (P = 0.0001) in VAS, ESR and CRP at 4 weeks was observed in Group B2. It was possible to isolate the pathogen in 52.8% of Group B, without any differences on VAS, ESR and CRP values and on length of the antibiotic therapy.
CONCLUSIONS


The surgical treatment should be considered for patients who, after 4 weeks of conservative therapy, do not show a reduction in the ESR < 50 mm/h and of the CRP < 2.7 g/dl. The comparison between groups underwent surgically and those treated conservatively showed a reduction in the CRP at 4 weeks and better VAS for pain at 3 months in Group A.",2022,"Comparing Group B1 to B2, a reduction (P = 0.0001) in VAS, ESR and CRP at 4 weeks was observed in Group B2.",['Two groups of patients with NSS'],['antibiotic therapy for '],"['VAS, ESR and CRP', 'BMI, blood levels of ESR and CRP and VAS scale', 'CRP', 'VAS, ESR and CRP values and on length of the antibiotic therapy', 'VAS for pain']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0012624', 'cui_str': 'Discitis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0175471,"Comparing Group B1 to B2, a reduction (P = 0.0001) in VAS, ESR and CRP at 4 weeks was observed in Group B2.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Giampaolini', 'Affiliation': 'Clinica Ortopedica dell\'Adulto e Pediatrica, AOU ""Ospedali Riuniti di Ancona"", Ancona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Berdini', 'Affiliation': ""Clinica Ortopedica dell'Adulto e Pediatrica, Department of Clinical and Molecular Sciences, Università Politecnica delle Marche, Di.S.Cli.Mo., Via Tronto 10/A, 60020, Ancona, Torrette, Italy. m.berdini@pm.univpm.it.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rotini', 'Affiliation': ""Clinica Ortopedica dell'Adulto e Pediatrica, Department of Clinical and Molecular Sciences, Università Politecnica delle Marche, Di.S.Cli.Mo., Via Tronto 10/A, 60020, Ancona, Torrette, Italy.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Palmisani', 'Affiliation': ""Clinica Ortopedica dell'Adulto e Pediatrica, Department of Clinical and Molecular Sciences, Università Politecnica delle Marche, Di.S.Cli.Mo., Via Tronto 10/A, 60020, Ancona, Torrette, Italy.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Specchia', 'Affiliation': ""Clinica Ortopedica dell'Adulto e Pediatrica, Department of Clinical and Molecular Sciences, Università Politecnica delle Marche, Di.S.Cli.Mo., Via Tronto 10/A, 60020, Ancona, Torrette, Italy.""}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Martiniani', 'Affiliation': 'Clinica Ortopedica dell\'Adulto e Pediatrica, AOU ""Ospedali Riuniti di Ancona"", Ancona, Italy.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-021-07072-z']
1045,35041000,Long-term outcomes in a randomized controlled trial of multimodality imaging-guided left ventricular lead placement in cardiac resynchronization therapy.,"AIMS


This study aims to investigate the long-term occurrence of the composite endpoint of heart failure (HF) hospitalization or all-cause death (primary endpoint) in patients randomized to cardiac resynchronization therapy (CRT) using individualized multimodality imaging-guided left ventricular (LV) lead placement compared with a routine fluoroscopic approach. Furthermore, this study aims to evaluate whether inter-lead electrical delay (IED) is associated with improved response rate of this endpoint.
METHODS AND RESULTS


We reviewed follow-up data until November 2020 for all 182 patients included in the ImagingCRT trial for the occurrence of HF hospitalization and all-cause death. During median (inter-quartile range) time to primary endpoint/censuring of 6.7 (3.3-7.9) years, the rate of the primary endpoint was 60% (n = 53) in the imaging group compared with 52% (n = 48) in the control group [hazard ratio (HR) 1.22, 95% confidence interval (CI) 0.83-1.81, P = 0.31]. Neither the risk of HF hospitalization (HR 1.11, 95% CI 0.62-1.99, P = 0.72) nor of all-cause death differed between treatment groups (HR 1.23, 95% CI 0.82-1.85, P = 0.32). The risk of the primary endpoint was significantly reduced among those with IED ≥100 ms when compared with those with IED <100 ms (HR 0.62, 95% CI 0.39-0.98, P = 0.04).
CONCLUSIONS


In this study, an individualized multimodality imaging-guided strategy targeting LV lead placement towards the latest mechanically activated non-scarred myocardial segment during CRT implantation did not reduce HF hospitalization or all-cause death when compared with routine LV lead placement during long-term follow-up. Targeting the latest electrical activation should be studied as an alternative individualized strategy for optimizing LV lead placement in CRT recipients.",2022,"Neither the risk of HF hospitalization (HR 1.11, 95% CI 0.62-1.99, P = 0.72) nor of all-cause death differed between treatment groups (HR 1.23, 95% CI 0.82-1.85, P = 0.32).","['We reviewed follow-up data until November 2020 for all 182 patients included in the ImagingCRT trial for the occurrence of HF hospitalization and all-cause death', 'patients randomized to']","['cardiac resynchronization therapy (CRT', 'multimodality imaging-guided left ventricular lead placement', 'routine fluoroscopic approach', 'individualized multimodality imaging-guided left ventricular (LV) lead placement']","['risk of HF hospitalization', 'hazard ratio (HR', 'HF hospitalization', 'cause death']","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C1513743', 'cui_str': 'Imaging, Multimodal'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.208245,"Neither the risk of HF hospitalization (HR 1.11, 95% CI 0.62-1.99, P = 0.72) nor of all-cause death differed between treatment groups (HR 1.23, 95% CI 0.82-1.85, P = 0.32).","[{'ForeName': 'Daniel Benjamin', 'Initials': 'DB', 'LastName': 'Fyenbo', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Sommer', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Bjarne Linde', 'Initials': 'BL', 'LastName': 'Nørgaard', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Mads Brix', 'Initials': 'MB', 'LastName': 'Kronborg', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerdes', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Henrik Kjærulf', 'Initials': 'HK', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Jesper Møller', 'Initials': 'JM', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Jens Cosedis', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euab314']
1046,34890063,NASHFit: A randomized controlled trial of an exercise training program to reduce clotting risk in patients with NASH.,"BACKGROUND AND AIMS


NASH is a common disease associated with increased rates of thromboembolism (TE). Although exercise training can lessen thrombotic risk in patients with vascular disease, whether similar findings are observed in patients with NASH is open for study.
APPROACH AND RESULTS


We conducted a 20-week randomized controlled clinical trial involving patients with biopsy-confirmed NASH. Patients were randomly assigned (2:1 ratio) to receive either an exercise training program or standard clinical care. The primary endpoint was change in plasminogen activator inhibitor 1 (PAI-1) level, an established thrombotic biomarker. Twenty-eight patients were randomly assigned (18 exercise training and 10 standard clinical care). PAI-1 level was significantly decreased by exercise training when compared to standard clinical care (-40 ± 100 vs. +70 ± 63 ng/ml; p = 0.02). Exercise training decreased MRI proton density fat fraction (MRI-PDFF; -4.7 ± 5.6 vs. 1.2 ± 2.8% absolute liver fat; p = 0.01); 40% of exercise subjects had a ≥30% relative reduction in MRI-PDFF (histological response threshold) compared to 13% for standard of care (p < 0.01). Exercise training improved fitness (VO 2  peak, +3.0 ± 5.6 vs. -1.8 ± 5.1 ml/kg/min; p = 0.05) in comparison to standard clinical care.
CONCLUSIONS


This clinical trial showed that, independent of weight loss or dietary change, exercise training resulted in a significantly greater decrease in thrombotic risk than standard clinical care in patients with NASH, in parallel with MRI-PDFF reduction and improvement in fitness. Future studies are required to determine whether exercise training can directly impact patient outcomes and lower rates of TE.",2022,"Exercise training improved fitness (VO 2  peak, +3.0 ± 5.6 vs. -1.8 ± 5.1 ml/kg/min; p = 0.05) in comparison to standard clinical care.
","['patients with vascular disease', 'patients with NASH', 'patients with biopsy-confirmed NASH', 'Twenty-eight patients']","['exercise training program', 'Exercise training', 'exercise training program or standard clinical care', 'exercise training and 10 standard clinical care', 'NASHFit', 'exercise training']","['clotting risk', 'change in plasminogen activator inhibitor 1 (PAI-1) level, an established thrombotic biomarker', 'MRI proton density fat fraction (MRI-PDFF', 'rates of thromboembolism (TE', 'thrombotic risk', 'PAI-1 level', 'MRI-PDFF (histological response threshold']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",28.0,0.0267887,"Exercise training improved fitness (VO 2  peak, +3.0 ± 5.6 vs. -1.8 ± 5.1 ml/kg/min; p = 0.05) in comparison to standard clinical care.
","[{'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Stine', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Schreibman', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Faust', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Dahmus', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stern', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Soriano', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Gloriany', 'Initials': 'G', 'LastName': 'Rivas', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Breianna', 'Initials': 'B', 'LastName': 'Hummer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Scot R', 'Initials': 'SR', 'LastName': 'Kimball', 'Affiliation': 'Department of Physiology, The Pennsylvania State University-College of Medicine, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Nate R', 'Initials': 'NR', 'LastName': 'Geyer', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University-College of Medicine, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University-College of Medicine, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Schmitz', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University-College of Medicine, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sciamanna', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University-College of Medicine, Hershey, Pennsylvania, USA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.32274']
1047,35041936,Facilitatory Effect of Intermittent Repetitive Transcranial Magnetic Stimulation on Perceptual Distortion of the Face.,"Orofacial pain patients often report that the painful facial area is ""swollen"" without clinical signs - known as perceptual distortion (PD). The neuromodulatory effect of facilitatory repetitive transcranial magnetic stimulation (rTMS) on PD in healthy individuals was investigated, to provide further support that the primary somatosensory cortex (SI) is involved in facial PD. Participants were allocated to active (n = 26) or sham (n = 26) rTMS group in this case-control study. PD was induced experimentally by injecting local anesthesia (LA) in the right infraorbital region. PD was measured at baseline, 6 min after LA, immediately, 20 and 40 min after rTMS. Intermittent theta-burst stimulation (iTBS) as active rTMS and sham rTMS was applied to the face representation area of SI at 10 min after LA. The magnitude of PD was compared between the groups. The magnitude of PD significantly increased immediately after iTBS compared with sham rTMS (P = .009). The PD was significantly higher immediately after iTBS compared to 6 min after LA (P = .004) in the active rTMS group, but not in the sham rTMS group (P = .054). iTBS applied to a somatotopic-relevant cortical region appears to facilitate facial PD further supporting the involvement of SI in the processing of one´s own face and PD. PERSPECTIVE: This study provides information on neural substrate responsible for processing of perceptual distortion of the face which is speculated to contribute to the chronification of orofacial pain. The findings of this study may aid in mechanism-based management of the condition in orofacial pain disorders and possibly other chronic pain states.",2022,The magnitude of PD significantly increased immediately after iTBS compared with sham rTMS (P=0.009).,"['Orofacial pain patients', 'healthy individuals']","['local anesthesia (LA', 'rTMS', 'facilitatory repetitive transcranial magnetic stimulation (rTMS', 'Intermittent Repetitive Transcranial Magnetic Stimulation', 'Intermittent theta-burst stimulation (iTBS) as active rTMS and sham rTMS']","['magnitude of PD', 'PD', 'Perceptual Distortion of the Face']","[{'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",,0.0416004,The magnitude of PD significantly increased immediately after iTBS compared with sham rTMS (P=0.009).,"[{'ForeName': 'Simple Futarmal', 'Initials': 'SF', 'LastName': 'Kothari', 'Affiliation': 'Section for Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark; Scandinavian Center for Orofacial Neurosciences (SCON); Hammel Neurorehabilitation Center and University Research Clinic, Aarhus University, Hammel, Denmark. Electronic address: simple.futarmal@dent.au.dk.'}, {'ForeName': 'Jakob U', 'Initials': 'JU', 'LastName': 'Blicher', 'Affiliation': 'CFIN, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lilja K', 'Initials': 'LK', 'LastName': 'Dagsdottir', 'Affiliation': 'Section for Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark; Scandinavian Center for Orofacial Neurosciences (SCON).'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Kothari', 'Affiliation': 'Hammel Neurorehabilitation Center and University Research Clinic, Aarhus University, Hammel, Denmark; JSS Dental College and Hospital, JSS Academy of Higher Education and Research, Mysore, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Scandinavian Center for Orofacial Neurosciences (SCON); Department of Dental Medicine, Karolinska Institute, Huddinge, Sweden.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Sengupta', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark; Larix A/S, Herlev, Denmark.'}, {'ForeName': 'Poul E', 'Initials': 'PE', 'LastName': 'Buchholtz', 'Affiliation': 'Department for Depression and Anxiety Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Ashkanian', 'Affiliation': 'Department for Depression and Anxiety Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section for Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark; Scandinavian Center for Orofacial Neurosciences (SCON); Department of Orofacial Pain and Jaw Function, Faculty of Odontology, Malmӧ University, Malmӧ, Sweden.'}]",The journal of pain,['10.1016/j.jpain.2021.12.013']
1048,35049354,Outpatient Randomized Crossover Automated Insulin Delivery Versus Conventional Therapy with Induced Stress Challenges.,"Background:  Automated insulin delivery (AID) systems have not been evaluated in the context of psychological and pharmacological stress in type 1 diabetes. Our objective was to determine glycemic control and insulin use with Zone Model Predictive Control (zone-MPC) AID system enhanced for states of persistent hyperglycemia versus sensor-augmented pump (SAP) during outpatient use, including in-clinic induced stress.  Materials and Methods:  Randomized, crossover, 2-week trial of zone-MPC AID versus SAP in 14 adults with type 1 diabetes. In each arm, each participant was studied in-clinic with psychological stress induction (Trier Social Stress Test [TSST] and Socially Evaluated Cold Pressor Test [SECPT]), followed by pharmacological stress induction with oral hydrocortisone (total four sessions per participant). The main outcomes were 2-week continuous glucose monitor percent time in range (TIR) 70-180 mg/dL, and glucose and insulin outcomes during and overnight following stress induction.  Results:  During psychological stress, AID decreased glycemic variability percentage by 13.4% ( P  = 0.009). During pharmacological stress, including the following overnight, there were no differences in glucose outcomes and total insulin between AID and physician-assisted SAP. However, with AID total user-requested insulin was lower by 6.9 U ( P  = 0.01) for pharmacological stress. Stress induction was validated by changes in heart rate and salivary cortisol levels. During the 2-week AID use, TIR was 74.4% (vs. SAP 63.1%,  P  = 0.001) and overnight TIR was 78.3% (vs. SAP 63.1%,  P  = 0.004). There were no adverse events.  Conclusions:  Zone-MPC AID can reduce glycemic variability and the need for user-requested insulin during pharmacological stress and can improve overall glycemic outcomes. Clinical Trial Identifier NCT04142229.",2022,"However, with AID total user-requested insulin was lower by 6.9 U (p=0.01) for pharmacological stress.",['14 adults with type 1 diabetes'],"['Insulin Delivery versus Conventional Therapy', 'Zone Model Predictive Control (zone-MPC', 'zone-MPC AID versus SAP', 'sensor-augmented pump (SAP', 'psychological stress induction (Trier Social Stress Test (TSST) and Socially Evaluated Cold Pressor Test (SECPT)), followed by pharmacological stress induction with oral hydrocortisone']","['glycemic variability', 'overall glycemic outcomes', 'overnight TIR', 'glycemic variability percentage', 'glucose outcomes and total insulin between AID and physician-assisted SAP', 'continuous glucose monitor percent time in range (TIR) 70-180 mg/dL, and glucose and insulin outcomes during and overnight following stress induction', 'heart rate and salivary cortisol levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0449421', 'cui_str': 'Pharmacological stress'}, {'cui': 'C0360554', 'cui_str': 'Hydrocortisone-containing product in oral dose form'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",14.0,0.0382851,"However, with AID total user-requested insulin was lower by 6.9 U (p=0.01) for pharmacological stress.","[{'ForeName': 'Ravinder Jeet', 'Initials': 'RJ', 'LastName': 'Kaur', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Deshpande', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California, USA.'}, {'ForeName': 'Wesley P', 'Initials': 'WP', 'LastName': 'Gilliam', 'Affiliation': 'Department of Psychiatry, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'McCrady-Spitzer', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zaniletti', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Desjardins', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle Iii', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Walter K', 'Initials': 'WK', 'LastName': 'Kremers', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2021.0436']
1049,35060676,An adaptive design for early clinical development including interim decision for single-arm trial with external controls or randomized trial.,"In early clinical development, randomized controlled trials (RCT) or single-arm trials with external controls (SATwEC) are design options, which allow adjustment for confounding: RCT via design, SATwEC via analysis using propensity score methods. SATwEC requires less investment than RCT. However, if the confounder space substantially differs between the experimental and external control group, the SATwEC might lead to inappropriate decisions for further development. We develop an adaptive two-stage design (ATD) for early clinical development that reduces the risk of unreliable decision-making at the end of a SATwEC. In Stage I, subjects are solely assigned to the experimental group. If at the interim the propensity score distributions of internal and external data are comparable based on the preference score, the subjects in stage II will again be solely assigned to the experimental arm; if not, a randomized stage II will be conducted. In a simulation study guided by a motivating example, data is generated using a time-to-event model with observable and unobservable confounders. The confounder space is varied to investigate the impact on false go/stop probabilities as well as a loss function, which reflects the quality of treatment effect estimates and decision-making. The proposed ATD provides a compromise between optimizing quality (as expressed by false go/stop probabilities and the loss function) and investment (defined by sample size and trial duration).",2022,We develop an adaptive two-stage design (ATD) for early clinical development that reduces the risk of unreliable decision-making at the end of a SATwEC.,[],[],[],[],[],[],,0.199864,We develop an adaptive two-stage design (ATD) for early clinical development that reduces the risk of unreliable decision-making at the end of a SATwEC.,"[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Götte', 'Affiliation': 'Global Biostatistics, Epidemiology & Medical Writing, Merck Healthcare KGaA, Darmstadt, Germany.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'Kirchner', 'Affiliation': 'Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Allignol', 'Affiliation': 'Global Biostatistics, Epidemiology & Medical Writing, Merck Healthcare KGaA, Darmstadt, Germany.'}, {'ForeName': 'Francois-Xavier', 'Initials': 'FX', 'LastName': 'Lamy', 'Affiliation': 'Global Biostatistics, Epidemiology & Medical Writing, Merck Healthcare KGaA, Darmstadt, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schüler', 'Affiliation': 'Global Biostatistics, Epidemiology & Medical Writing, Merck Healthcare KGaA, Darmstadt, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Kieser', 'Affiliation': 'Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany.'}]",Pharmaceutical statistics,['10.1002/pst.2190']
1050,35561566,Fertility-related quality of life in subfertile women undergoing tubal testing with transvaginal hydrolaparoscopy or hysterosalpingography.,"OBJECTIVE


Both subfertility and its management can have significant impact on quality of life (QoL). Tubal patency testing as part of the fertility work-up, is considered to cause more physical complaints and stress than other tests. Pain scores for HSG are higher than for THL, but acceptability of the procedures was found to be comparable. Fertility-related QoL has not yet been studied in women undergoing tubal patency testing.
STUDY DESIGN


We performed a standardized questionnaire study alongside a previously reported randomized controlled trial comparing THL and HSG in subfertile women, in which 24-month live birth rates occurred in 58.5% versus 55.4%, respectively. We randomly assigned 300 subfertile women to THL or HSG between May 2013 and October 2016. Women were eligible if they were undergoing a fertility work-up with an indication for evaluation of tubal patency. Fertility-related QoL was measured six weeks after the procedure with the validated FertiQoL questionnaire. The scores for the Core scale and subscales between THL and HSG were compared using Mann-Whitney-U test and multiple linear regression analysis.
RESULTS


The questionnaire was completed by 84 women in the THL group (56%) and 96 women in the HSG group (64%). Core scores were 74.6 ± 12.8 for THL and 73.4 ± 12.4 for HSG (p = 0.39). Scores for the Emotional domain were 64.5 ± 19.0 for THL versus 66.0 ± 16.3 (p = 0.67) for HSG. Scores for the 'Mind-body' domain for THL were 76.9 ± 15.6 versus 74.1 ± 18.0 for HSG (p = 0.42), while scores for the Relational domain were 79.2 ± 12.9 for THL and 76.9 ± 15.6 for HSG (p = 0.21). Scores for the Social domain for THL were 77.9 ± 15.1 versus 76.7 ± 14.1, (p = 0.42). The multiple linear regression analysis showed only a statistical significant positive effect of older age on the score for the Emotional domain (p = 0.015).
CONCLUSION


In a preselected group of women with low risk for tubal pathology we did not find differences in fertility-related QoL between tubal patency testing with THL versus HSG.",2022,In a preselected group of women with low risk for tubal pathology we did not find differences in fertility-related QoL between tubal patency testing with THL versus HSG.,"['84 women in the THL group (56%) and 96 women in the', 'subfertile women undergoing tubal testing with', 'women undergoing tubal patency testing', 'subfertile women', '300 subfertile women to THL or HSG between May 2013 and October 2016', 'Women were eligible if they were undergoing a fertility work-up with an indication for evaluation of tubal patency']","['THL versus HSG', 'THL and HSG', 'transvaginal hydrolaparoscopy or hysterosalpingography', 'HSG']","['quality of life (QoL', 'live birth rates', 'Pain scores', 'Fertility-related QoL', 'Fertility-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",300.0,0.0456771,In a preselected group of women with low risk for tubal pathology we did not find differences in fertility-related QoL between tubal patency testing with THL versus HSG.,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'van Kessel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Dr. Horacio E. Oduber Hospital Aruba, Oranjestad, Aruba. Electronic address: m.vankessel@hoharuba.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paulussen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: milou.paulussen@mumc.nl.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tros', 'Affiliation': 'Department of Obstetrics and Gynaecology, VU University Medical Center Amsterdam, 1007 MB Amsterdam, the Netherlands. Electronic address: r.tros@vumc.nl.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Department of Obstetrics and Gynaecology, Maxima Medical Center, 5500 MB Veldhoven, the Netherlands. Electronic address: m.bongers@mmc.nl.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': ""Monash University, Department of Obstetrics and Gynaecology, Clayton, Australia; Aberdeen Centre for Women's Health Research, University of Aberdeen, Aberdeen, UK. Electronic address: ben.mol@monash.edu.""}, {'ForeName': 'C A M', 'Initials': 'CAM', 'LastName': 'Koks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maxima Medical Center, 5500 MB Veldhoven, the Netherlands. Electronic address: c.koks@mmc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2022.04.005']
1051,35561538,Cannabidiol enhancement of exposure therapy in treatment refractory patients with social anxiety disorder and panic disorder with agoraphobia: A randomised controlled trial.,"Preclinical research suggests that enhancing CB1 receptor agonism may improve fear extinction. In order to translate this knowledge into a clinical application we examined whether cannabidiol (CBD), a hydrolysis inhibitor of the endogenous CB1 receptor agonist anandamide (AEA), would enhance the effects of exposure therapy in treatment refractory patients with anxiety disorders. Patients with panic disorder with agoraphobia or social anxiety disorder were recruited for a double-blind parallel randomised controlled trial at three mental health care centres in the Netherlands. Eight therapist-assisted exposure in vivo sessions (weekly, outpatient) were augmented with 300 mg oral CBD (n = 39) or placebo (n = 41). The Fear Questionnaire (FQ) was assessed at baseline, mid- and post-treatment, and at 3 and 6 months follow-up. Primary analyses were on an intent-to-treat basis. No differences were found in treatment outcome over time between CBD and placebo on FQ scores, neither across (β = 0.32, 95% CI [-0.60; 1.25]) nor within diagnosis groups (β = -0.11, 95% CI [-1.62; 1.40]). In contrast to our hypotheses, CBD augmentation did not enhance early treatment response, within-session fear extinction or extinction learning. Incidence of adverse effects was equal in the CBD (n = 4, 10.3%) and placebo condition (n = 6, 15.4%). In this first clinical trial examining CBD as an adjunctive therapy in anxiety disorders, CBD did not improve treatment outcome. Future clinical trials may investigate different dosage regimens.",2022,"In contrast to our hypotheses, CBD augmentation did not enhance early treatment response, within-session fear extinction or extinction learning.","['treatment refractory patients with social anxiety disorder and panic disorder with agoraphobia', 'Patients with panic disorder with agoraphobia or social anxiety disorder', 'refractory patients with anxiety disorders']","['placebo', 'Eight therapist-assisted exposure in vivo sessions (weekly, outpatient) were augmented with 300\xa0mg oral CBD', 'exposure therapy']","['Incidence of adverse effects', 'Fear Questionnaire (FQ', 'FQ scores']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0236800', 'cui_str': 'Panic disorder with agoraphobia'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.2269,"In contrast to our hypotheses, CBD augmentation did not enhance early treatment response, within-session fear extinction or extinction learning.","[{'ForeName': 'Caroline Mb', 'Initials': 'CM', 'LastName': 'Kwee', 'Affiliation': 'Department of Experimental Psychology and Helmholtz Institute, Faculty of Social and Behavioural Sciences, Utrecht University, Utrecht, the Netherlands; Altrecht Academic Anxiety Centre, Utrecht, the Netherlands. Electronic address: c.kwee@altrecht.nl.'}, {'ForeName': 'Johanna Mp', 'Initials': 'JM', 'LastName': 'Baas', 'Affiliation': 'Department of Experimental Psychology and Helmholtz Institute, Faculty of Social and Behavioural Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Febe E', 'Initials': 'FE', 'LastName': 'van der Flier', 'Affiliation': 'Altrecht Academic Anxiety Centre, Utrecht, the Netherlands.'}, {'ForeName': 'Lucianne', 'Initials': 'L', 'LastName': 'Groenink', 'Affiliation': 'Department of Pharmaceutical Sciences, Division of Pharmacology, UIPS, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Puck', 'Initials': 'P', 'LastName': 'Duits', 'Affiliation': 'Altrecht Academic Anxiety Centre, Utrecht, the Netherlands.'}, {'ForeName': 'Merijn', 'Initials': 'M', 'LastName': 'Eikelenboom', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, VU University Medical Centre and GGZ inGeest, Amsterdam, the Netherlands.'}, {'ForeName': 'Date C', 'Initials': 'DC', 'LastName': 'van der Veen', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Moerbeek', 'Affiliation': 'Department of Methodology and Statistics, Faculty of Social and Behavioural Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Neeltje M', 'Initials': 'NM', 'LastName': 'Batelaan', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, VU University Medical Centre and GGZ inGeest, Amsterdam, the Netherlands.'}, {'ForeName': 'Anton Jlm', 'Initials': 'AJ', 'LastName': 'van Balkom', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, VU University Medical Centre and GGZ inGeest, Amsterdam, the Netherlands.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Cath', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; GGZ Drenthe, Department of Specialist Trainings, Assen, the Netherlands.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2022.04.003']
1052,35561480,"Regulation of NLRP3 inflammasome by zinc supplementation in Behçet's disease patients: A double-blind, randomized placebo-controlled clinical trial.","BACKGROUND


Overproduction of NLRP3 inflammasome complex is one of the causes of Behcet's disease's (BD) auto-inflammatory nature. The aim of current study was to examine the effect of zinc supplementation on NLRP3 inflammasome expression; as well as clinical manifestations of BD.
METHODS


In this double-blind parallel placebo-controlled randomized clinical trial, 50 BD patients were randomly allocated into either zinc gluconate (30 mg/day elemental zinc) or placebo groups for 12 weeks. The mRNA expression of NLRP3 and caspase-1 in the leukocytes, serum level of zinc and IL-1β, anthropometric measures, and clinical manifestations of patients were collected at pre- and post-intervention phase. The Iranian Behçet's disease dynamic activity measure (IBDDAM) was scored to measure the treatment effect using the calculation of number needed to treat (NNT). Analysis of covariance was performed to obtain the corresponding effect sizes.
RESULTS


Zinc gluconate led to a significant improvement in genital ulcer (P = 0.019). Zinc supplementation decreased NLRP3 and caspase-1 genes expression compared with placebo group (baseline-adjusted P-value = 0.046 for NLRP3 and P-value = 0.003 for caspase-1), even after adjustment for the effect of confounding factors (baseline- and confounders-adjusted P-value = 0.032 for NLRP3 and P-value = 0.004 for caspase-1). Baseline and confounders adjusted effect size demonstrated that zinc was effective in reducing the serum level of IL-1β (P = 0.046). The NNT [95 %CI] for the rate of IBDDAM improvement was 3 [1.7-8.5].
CONCLUSIONS


Zinc gluconate supplementation (30 mg/day) for a 3-month period can be considered as an adjuvant therapy in alleviating inflammation and genital ulcer among BD patients.",2022,"Zinc supplementation decreased NLRP3 and caspase-1 genes expression compared with placebo group (baseline-adjusted P-value = 0.046 for NLRP3 and P-value = 0.003 for caspase-1), even after adjustment for the effect of confounding factors (baseline- and confounders-adjusted P-value = 0.032 for NLRP3 and P-value = 0.004 for caspase-1).","[""Behçet's disease patients"", '50 BD patients']","['Zinc gluconate supplementation', 'zinc gluconate (30\xa0mg/day elemental zinc) or placebo', 'Zinc supplementation', 'placebo', 'Zinc gluconate', 'zinc supplementation', 'NLRP3 inflammasome by zinc supplementation']","['mRNA expression of NLRP3 and caspase-1 in the leukocytes, serum level of zinc and IL-1β, anthropometric measures, and clinical manifestations', 'rate of IBDDAM improvement', 'NLRP3 and caspase-1 genes expression', 'NLRP3 inflammasome expression', 'genital ulcer', 'serum level of IL-1β']","[{'cui': 'C0004943', 'cui_str': ""Behcet's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C2936529', 'cui_str': 'Inflammasome'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0534519', 'cui_str': 'Caspase-1'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C2936529', 'cui_str': 'Inflammasome'}, {'cui': 'C0151281', 'cui_str': 'Genital ulceration'}]",50.0,0.701934,"Zinc supplementation decreased NLRP3 and caspase-1 genes expression compared with placebo group (baseline-adjusted P-value = 0.046 for NLRP3 and P-value = 0.003 for caspase-1), even after adjustment for the effect of confounding factors (baseline- and confounders-adjusted P-value = 0.032 for NLRP3 and P-value = 0.004 for caspase-1).","[{'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Faghfouri', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Community Nutrition, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Baradaran', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khabbazi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Abdoli Shadbad', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Papi', 'Affiliation': 'Department of Public Health, Faculty of Health, Social Determinants of Health Research Center, Ahvaz Jundishapour University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Faghfuri', 'Affiliation': 'Digestive Disease Research Center, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Khajebishak', 'Affiliation': 'Department of Nutrition, Maragheh University of Medical Sciences, Maragheh, I.R., Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Rahmani', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Parastoo', 'Initials': 'P', 'LastName': 'Tolou Hayat', 'Affiliation': 'Department of Community Nutrition, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Beitullah', 'Initials': 'B', 'LastName': 'Alipour', 'Affiliation': 'Department of Community Nutrition, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: alipourb@tbzmed.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2022.108825']
1053,35562681,Older adults' perspectives on rehabilitation and recovery one year after a hip fracture - a qualitative study.,"BACKGROUND


In order to improve quality of care and recovery after hip fracture we need to include the perspectives of the individual older adults when evaluating different rehabilitation interventions. The aim of this study was therefore to explore older adults' experiences of their rehabilitation after a hip fracture and of the recovery process during the 12 months following the fracture.
METHODS


Qualitative interviews were conducted with 20 older adults (70-91 years of age) who had participated in a randomised controlled trial evaluating the effects of early discharge followed by geriatric interdisciplinary home rehabilitation compared to in-hospital care according to a multifactorial rehabilitation program. Ten participants from each group were interviewed shortly after the one-year follow-up when the study was completed. Data were analysed with qualitative content analysis.
RESULTS


The analysis resulted in four themes: Moving towards recovery with the help of others; Getting to know a new me; Striving for independence despite obstacles; and Adapting to an altered but acceptable life. The participants emphasised the importance of having access to rehabilitation that was provided by skilled staff, and support from family members and friends for well-being and recovery. They experienced a change in their self-image but strove for independence despite struggling with complications and functional limitations and used adaptive strategies to find contentment in their lives.
CONCLUSIONS


Rehabilitation interventions provided by competent health care professionals, as well as support from family members and friends, were emphasised as crucial for satisfactory recovery. Participants' experiences further highlight the importance of targeting both physical and psychological impacts after a hip fracture. To improve recovery, rehabilitation providers should customise future interventions to suit each individual´s wishes and needs and provide rehabilitation in various settings throughout the recovery process.
TRIAL REGISTRATION


The trial is registered at Current Controlled Trials Ltd, ICRCTN 15738119 . Date of registration 16/06/2008, retrospectively registered.",2022,The analysis resulted in four themes: Moving towards recovery with the help of others; Getting to know a new me; Striving for independence despite obstacles; and Adapting to an altered but acceptable life.,"[""older adults' experiences"", 'Qualitative interviews were conducted with 20 older adults (70-91\xa0years of age) who had participated', 'Older adults']",['early discharge followed by geriatric interdisciplinary home rehabilitation compared to in-hospital care according to a multifactorial rehabilitation program'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]",[],10.0,0.107119,The analysis resulted in four themes: Moving towards recovery with the help of others; Getting to know a new me; Striving for independence despite obstacles; and Adapting to an altered but acceptable life.,"[{'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Karlsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, 90187, Umeå, Sweden. asa.karlsson@umu.se.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Olofsson', 'Affiliation': 'Department of Nursing and Department of Surgical and Perioperative Science, Orthopedics, Umeå University, 90187, Umeå, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stenvall', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, 90187, Umeå, Sweden.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lindelöf', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, 90187, Umeå, Sweden.'}]",BMC geriatrics,['10.1186/s12877-022-03119-y']
1054,34969004,Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial.,"OBJECTIVE


Compare transversus abdominis plane (TAP) blocks with liposomal bupivacaine were to epidural analgesia for pain at rest and opioid consumption in patients recovering from abdominal surgery.
BACKGROUND


ERAS pathways suggest TAP blocks in preference to epidural analgesia for abdominal surgery. However, the relative efficacies of TAP blocks and epidural analgesia remains unknown.
METHODS


Patients having major abdominal surgery were enrolled at six sites and randomly assigned 1:1 to thoracic epidural analgesia or bilateral/4-quadrant TAP blocks with liposomal bupivacaine. Intravenous opioids were used as needed. Non-inferiority margins were a priori set at 1 point on an 11-point pain numeric rating scale for pain at rest and at a 25% increase in postoperative opioid consumption.
RESULTS


Enrollment was stopped per protocol at 3rd interim analysis after crossing an a priori futility boundary. 498 patients were analyzed (255 had TAP blocks and 243 had epidurals). Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI: -0.12, 0.30; noninferiority P < 0.001). Opioid consumption during the initial 3 postoperative days in TAP patients was not non-inferior to epidurals, with an estimated ratio of geometric means of 1.37 (CI: 1.05, 1.79; non-inferiority P = 0.754). However, the absolute difference was only 21 mg morphine equivalents over the 3 days. Patients with epidurals were more likely to experience mean arterial pressures <65 mmHg than those given TAP blocks: 48% versus 31%, P = 0.006.
CONCLUSION


Pain scores at rest during the initial three days after major abdominal surgery were similar. Patients assigned to TAP blocks required more opioid then epidural patients but had less hypotension. Clinicians should reconsider epidural analgesia in patients at risk from hypotension.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02996227.",2022,"Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI: -0.12, 0.30; noninferiority P < 0.001).","['patients at risk from hypotension', 'major abdominal surgery', 'Patients having major abdominal surgery were enrolled at six sites', 'patients recovering from abdominal surgery', '498 patients were analyzed (255 had TAP blocks and 243 had epidurals']","['liposomal bupivacaine', 'Intravenous opioids', 'transversus abdominis plane (TAP) blocks with liposomal bupivacaine', 'TAP blocks', 'thoracic epidural analgesia or bilateral/4-quadrant TAP blocks with liposomal bupivacaine']","['Pain scores', 'pain at rest and opioid consumption', 'postoperative opioid consumption', 'experience mean arterial pressures', 'Opioid consumption', 'hypotension', '11-point pain numeric rating scale for pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",498.0,0.484211,"Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI: -0.12, 0.30; noninferiority P < 0.001).","[{'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of General Anesthesiology, Cleveland Clinic, United States of America. Electronic address: turana@ccf.org.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Division of Anesthesiology, Intensive Care, and Pain Management, Tel-Aviv Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Elsharkawy', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Pain Center, Anesthesiology Department, MetroHealth, Case Western Reserve University, OH, United States of America.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Loran Mounir', 'Initials': 'LM', 'LastName': 'Soliman', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Rovnat', 'Initials': 'R', 'LastName': 'Babazade', 'Affiliation': 'Department of Anesthesiology, University of Texas Medical Branch of Galveston, TX, United States of America.'}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Hassan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Elkassabany', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Hani A', 'Initials': 'HA', 'LastName': 'Essber', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Kessler', 'Affiliation': 'Department of Colorectal Surgery, Cleveland Clinic, United States of America.'}, {'ForeName': 'Guangmei', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of Quantitative Health Sciences, Cleveland Clinic.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110640']
1055,35561721,"Human versus equine intramuscular antitoxin, with or without human intrathecal antitoxin, for the treatment of adults with tetanus: a 2 × 2 factorial randomised controlled trial.","BACKGROUND


Intramuscular antitoxin is recommended in tetanus treatment, but there are few data comparing human and equine preparations. Tetanus toxin acts within the CNS, where there is limited penetration of peripherally administered antitoxin; thus, intrathecal antitoxin administration might improve clinical outcomes compared with intramuscular injection.
METHODS


In a 2  × 2 factorial trial, all patients aged 16 years or older with a clinical diagnosis of generalised tetanus admitted to the intensive care unit of the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, were eligible for study entry. Participants were randomly assigned first to 3000 IU human or 21 000 U equine intramuscular antitoxin, then to either 500 IU intrathecal human antitoxin or sham procedure. Interventions were delivered by independent clinicians, with attending clinicians and study staff masked to treatment allocations. The primary outcome was requirement for mechanical ventilation. The analysis was done in the intention-to-treat population. The study is registered at ClinicalTrials.gov, NCT02999815; recruitment is completed.
FINDINGS


272 adults were randomly assigned to interventions between Jan 8, 2017, and Sept 29, 2019, and followed up until May, 2020. In the intrathecal allocation, 136 individuals were randomly assigned to sham procedure and 136 to antitoxin; in the intramuscular allocation, 109 individuals were randomly assigned to equine antitoxin and 109 to human antitoxin. 54 patients received antitoxin at a previous hospital, excluding them from the intramuscular antitoxin groups. Mechanical ventilation was given to 56 (43%) of 130 patients allocated to intrathecal antitoxin and 65 (50%) of 131 allocated to sham procedure (relative risk [RR] 0·87, 95% CI 0·66-1·13; p=0·29). For the intramuscular allocation, 48 (45%) of 107 patients allocated to human antitoxin received mechanical ventilation compared with 48 (44%) of 108 patients allocated to equine antitoxin (RR 1·01, 95% CI 0·75-1·36, p=0·95). No clinically relevant difference in adverse events was reported. 22 (16%) of 136 individuals allocated to the intrathecal group and 22 (11%) of 136 allocated to the sham procedure experienced adverse events related or possibly related to the intervention. 16 (15%) of 108 individuals allocated to equine intramuscular antitoxin and 17 (16%) of 109 allocated to human antitoxin experienced adverse events related or possibly related to the intervention. There were no intervention-related deaths.
INTERPRETATION


We found no advantage of intramuscular human antitoxin over intramuscular equine antitoxin in tetanus treatment. Intrathecal antitoxin administration was safe, but did not provide overall benefit in addition to intramuscular antitoxin administration.
FUNDING


The Wellcome Trust.",2022,"There were no intervention-related deaths.
","['136 individuals', '109 individuals', '16 (15%) of 108 individuals allocated to', 'adults with tetanus', '54 patients received', 'patients aged 16 years or older with a clinical diagnosis of generalised tetanus admitted to the intensive care unit of the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, were eligible for study entry', '272 adults', '130 patients allocated to', '107 patients allocated to']","['equine antitoxin and 109 to human antitoxin', 'sham procedure and 136 to antitoxin', 'human antitoxin received mechanical ventilation', 'Human versus equine intramuscular antitoxin, with or without human intrathecal antitoxin', 'intrathecal human antitoxin or sham procedure', 'Mechanical ventilation', 'equine intramuscular antitoxin', 'intrathecal antitoxin', 'antitoxin', 'Intrathecal antitoxin', 'U equine intramuscular antitoxin', 'equine antitoxin', 'intramuscular human antitoxin over intramuscular equine antitoxin']","['requirement for mechanical ventilation', 'adverse events']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0003445', 'cui_str': 'Antitoxin'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",272.0,0.260876,"There were no intervention-related deaths.
","[{'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Van Hao', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Huynh Thi', 'Initials': 'HT', 'LastName': 'Loan', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Lam Minh', 'Initials': 'LM', 'LastName': 'Yen', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Kestelyn', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Duc Du', 'Initials': 'DD', 'LastName': 'Hong', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Duong Bich', 'Initials': 'DB', 'LastName': 'Thuy', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Nguyen', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ha Thi Hai', 'Initials': 'HTH', 'LastName': 'Duong', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran Thi Diem', 'Initials': 'TTD', 'LastName': 'Thuy', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Phung Tran Huy', 'Initials': 'PTH', 'LastName': 'Nhat', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Phan Nguyen Quoc', 'Initials': 'PNQ', 'LastName': 'Khanh', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thi Phuong', 'Initials': 'NTP', 'LastName': 'Dung', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Hoan', 'Initials': 'NH', 'LastName': 'Phu', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Phong', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Pham Thi', 'Initials': 'PT', 'LastName': 'Lieu', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Pham Thi', 'Initials': 'PT', 'LastName': 'Tuyen', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Bui Thi Bich', 'Initials': 'BTB', 'LastName': 'Hanh', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ho Dang Trung', 'Initials': 'HDT', 'LastName': 'Nghia', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Pham Kieu Nguyet', 'Initials': 'PKN', 'LastName': 'Oanh', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Phan Vinh', 'Initials': 'PV', 'LastName': 'Tho', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran', 'Initials': 'T', 'LastName': 'Tan Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Hugo C', 'Initials': 'HC', 'LastName': 'Turner', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'H Rogier', 'Initials': 'HR', 'LastName': 'van Doorn', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Van Tan', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Wyncoll', 'Affiliation': ""Guy's and St Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Nicholas Pj', 'Initials': 'NP', 'LastName': 'Day', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research Building, University of Oxford, Oxford, UK; Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Geskus', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Van Vinh Chau', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'C Louise', 'Initials': 'CL', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research Building, University of Oxford, Oxford, UK. Electronic address: lthwaites@oucru.org.'}]",The Lancet. Global health,['10.1016/S2214-109X(22)00117-6']
1056,35561627,The effect of maternal multisensory stimulations on bath stress in premature infants: A randomized controlled clinical trial.,"Bathing in Neonatal Intensive Care Unit (NICU) is a stressful experience to preterm infants. Reducing this stress is an important challenge in bathing preterm infants. The aim of present study was to evaluate the effects of maternal supportive interventions on the stress caused by swaddled bathing in preterm infants. In this randomized clinical trial, 48 preterm infants randomly allocated into control and intervention groups. In intervention group the mothers were asked to initiate multisensory supportive interventions 5 min before and through swaddled bathing. In controls the mothers were only present during bathing. To determine the level of stress, infant responses were recorded by camera 5 min before bathing and 5 min after bathing. Then infants' stress measured by using Newborn Stress Scale (NSS). Finding was shown that the level of stress in control group was especially increased after bathing that was statistically significant (p < 0.001). Although there was an increase in stress among interventions but it was not statistically significant (p > 0.05). Considering the positive effects of multisensory interventions in decreasing the stress of preterm infants, it can be recommended as cost-free and non-pharmacological care during infants bathing.",2022,Finding was shown that the level of stress in control group was especially increased after bathing that was statistically significant (p < 0.001).,"['48 preterm infants randomly allocated into control and intervention groups', 'bathing preterm infants', 'premature infants', 'preterm infants']","['maternal supportive interventions', 'Neonatal Intensive Care Unit (NICU', 'multisensory interventions', 'maternal multisensory stimulations']","['level of stress', 'Newborn Stress Scale (NSS', 'stress', 'level of stress, infant responses']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",48.0,0.0297368,Finding was shown that the level of stress in control group was especially increased after bathing that was statistically significant (p < 0.001).,"[{'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Soltani', 'Affiliation': 'Master of Science Neonatal Intensive Care Nursing, Student Research Center of Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: soltani.n95@gmail.com.'}, {'ForeName': 'Alehe', 'Initials': 'A', 'LastName': 'Seyedrasooli', 'Affiliation': 'Department of Medical surgical, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: aleheseyedrasooli@yahoo.com.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Jabraeili', 'Affiliation': 'Department of Pediatrics, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Jabraeilim@gmail.com.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Statistics and Epidemiology, Tabriz University of Medical Sciences, Faculty of Health Sciences, Tabriz, Iran. Electronic address: musavis@tbzmed.ac.ir.'}]",Infant behavior & development,['10.1016/j.infbeh.2022.101720']
1057,35051281,Effect of a multi-domain lifestyle intervention on cardiovascular risk in older people: the FINGER trial.,"AIMS


Joint prevention of cardiovascular disease (CVD) and dementia could reduce the burden of both conditions. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) demonstrated a beneficial effect on cognition (primary outcome) and we assessed the effect of this lifestyle intervention on incident CVD (pre-specified secondary outcome).
METHODS AND RESULTS


FINGER enrolled 1259 individuals aged 60-77 years (ClinicalTrials.gov NCT01041989). They were randomized (1:1) to a 2-year multi-domain intervention with diet, physical and cognitive activity, and vascular monitoring (n = 631), or general health advice (n = 628). National registries provided data on CVD including stroke, transient ischaemic attack (TIA), or coronary heart event. During an average of 7.4 years, 229 participants (18%) had at least one CVD diagnosis: 107 in the intervention group and 122 in the control group. The incidence of cerebrovascular events was lower in the intervention than the control group: hazard ratio (HR) for combined stroke/TIA was 0.71 [95% confidence interval (CI): 0.51-0.99] after adjusting for background characteristics. Hazard ratio for coronary events was 0.84 (CI: 0.56-1.26) and total CVD events 0.80 (95% CI: 0.61-1.04). Among those with history of CVD (n = 145), the incidence of both total CVD events (HR: 0.50, 95% CI: 0.28-0.90) and stroke/TIA (HR: 0.40, 95% CI: 0.20-0.81) was lower in the intervention than the control group.
CONCLUSION


A 2-year multi-domain lifestyle intervention among older adults was effective in preventing cerebrovascular events and also total CVD events among those who had history of CVD.",2022,A 2-year multi-domain lifestyle intervention among older adults was effective in preventing cerebrovascular events and also total CVD events among those with a history of CVD.,"['FINGER enrolled 1259 individuals aged 60-77 years (ClinicalTrials.gov NCT01041989', '1259 participants aged 60-77 years', 'older people', '229 participants (18%) had at least one CVD diagnosis: 107 in the intervention group and 122 in the control group', 'older adults', 'older adults over an extended follow-up']","['lifestyle intervention', '2-year multi-domain intervention with diet, physical and cognitive activity, and vascular monitoring (n = 631), or general health advice', 'multi-domain lifestyle intervention']","['cardiovascular risk', 'cerebrovascular events and also total CVD events', 'cardiovascular disease (CVD) event rates', 'CVD including stroke, transient ischaemic attack (TIA), or coronary heart event', 'total CVD events', 'Cerebrovascular event rates', 'incidence of cerebrovascular events', 'incidence of both total CVD events', 'cerebrovascular events', 'Cognitive Impairment and Disability (FINGER', 'Hazard ratio for coronary events']","[{'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",1259.0,0.135352,A 2-year multi-domain lifestyle intervention among older adults was effective in preventing cerebrovascular events and also total CVD events among those with a history of CVD.,"[{'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Lehtisalo', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Rusanen', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Antikainen', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Department of Public Health and Welfare, Population Health Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Peltonen', 'Affiliation': 'Department of Public Health and Welfare, Population Health Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Strandberg', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Department of Public Health and Welfare, Population Health Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Department of Public Health and Welfare, Population Health Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Ngandu', 'Affiliation': 'Department of Public Health and Welfare, Population Health Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}]",European heart journal,['10.1093/eurheartj/ehab922']
1058,35561572,First-trimester maternal serum betatrophin levels are decreased in pregnancies complicated by gestational diabetes mellitus.,"INTRODUCTION


The purpose of the present study was to compare maternal serum betatrophin levels during the first trimester from healthy pregnancies to those complicated by gestational diabetes mellitus (GDM).
METHODS


In this prospective study, 320 pregnant women were evaluated in their first trimester, and 145 pregnant women who met the inclusion criteria were divided into the following two groups according to GDM screening results: GDM (n:20) and non-diabetic healthy control (n: 125). Samples of maternal serum fasting insulin, fasting blood glucose, hemoglobin (HB)A1c, and betatrophin levels obtained from the women's blood samples between 11 +0/7  -13 +6/7  gestational weeks during first trimester nuchal translucency screening. 75-g oral glucose tolerance test protocol was preferred for GDM scanning between 24 +0/7  -28 +0/7  gestational weeks.
RESULTS


Maternal age and first-trimester body mass index (BMI) were higher in the GDM group than in the control group. Gestational age at blood draw was similar between the groups. First-trimester fasting insulin, fasting glucose, hemoglobin (Hb)A1c, thyroid-stimulating hormone, triiodothyronine (sT3), and thyroxine (sT4) were statistically similar between groups. First trimester Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) was 2.67 ± 1.42 in the GDM group and 2.12 ± 1.61 in the control group and not statistically different. Maternal age and BMI adjusted first-trimester maternal serum betatrophin levels were 11.58 ± 6.40 ng/mL in the GDM group and 31.11 ± 3.00 ng/mL in the control group and was statistically lower in the GDM group (p < 0.001).
DISCUSSION


Our results indicated that first trimester maternal serum betatrophin levels are decreased in pregnancies complicated by GDM and first trimester betatrophin levels could be an early screening tool for GDM to allow better pregnancy management.",2022,"ng/mL in the control group and was statistically lower in the GDM group (p < 0.001).
","['320 pregnant women were evaluated in their first trimester, and 145 pregnant women who met the inclusion criteria were divided into the following two groups according to GDM screening results: GDM (n:20) and non-diabetic healthy control (n: 125', 'healthy pregnancies to those complicated by gestational diabetes mellitus (GDM']",[],"['Maternal age and first-trimester body mass index (BMI', 'Maternal age and BMI adjusted first-trimester maternal serum betatrophin levels', 'maternal serum fasting insulin, fasting blood glucose, hemoglobin (HB)A1c, and betatrophin levels', 'Insulin Resistance (HOMA-IR', 'First-trimester fasting insulin, fasting glucose, hemoglobin (Hb)A1c, thyroid-stimulating hormone, triiodothyronine (sT3), and thyroxine (sT4', 'trimester maternal serum betatrophin levels', 'maternal serum betatrophin levels']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]",[],"[{'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0210233', 'cui_str': 'recombinant soluble CD4'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}]",320.0,0.0101385,"ng/mL in the control group and was statistically lower in the GDM group (p < 0.001).
","[{'ForeName': 'Mehmet Mete', 'Initials': 'MM', 'LastName': 'Kirlangic', 'Affiliation': 'Department of Obstetrics and Gynecology, Tuzla Government Hospital, Istanbul, Turkey. Electronic address: metekirlangic@gmail.com.'}, {'ForeName': 'Mefkure', 'Initials': 'M', 'LastName': 'Eraslan Sahin', 'Affiliation': 'Department of Obstetrics and Gynecology, Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Sahin', 'Affiliation': 'Department of Obstetrics and Gynecology, Erciyes University Medicine Faculty, Kayseri, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Madendag', 'Affiliation': 'Department of Obstetrics and Gynecology, Erciyes University Medicine Faculty, Kayseri, Turkey.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Col Madendag', 'Affiliation': 'Department of Obstetrics and Gynecology, Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Akdemir', 'Affiliation': 'Department of Obstetrics and Gynecology, Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Vural Yalman', 'Affiliation': 'Department of Obstetrics and Gynecology, Terme Government Hospital, Samsun, Turkey.'}]",Placenta,['10.1016/j.placenta.2022.05.001']
1059,35562420,The effect of calcium and vitamin D supplements on blood pressure in postmenopausal women: myth or reality?,"Hypertension is a highly prevalent disease with serious cardiovascular and renal complications. Many studies have demonstrated a weak correlation between the consumption of calcium (or calcium plus vitamin D) and blood pressure, suggesting that calcium supplements might reduce blood pressure. However, the results to date remain controversial. In this study, we assessed the effect of calcium and vitamin D supplementation on the blood pressure of postmenopausal women with hypertension as a population group in which the use of calcium supplements is prevalent. This triple-blind randomized clinical trial enrolled 98 women of postmenopausal age with hypertension in 2019. The study period was 8 weeks with close follow-up. We used 24-h ambulatory blood pressure monitoring to record the initial and final blood pressure in all participants. The changes in both the mean systolic (p = 0.047) and diastolic blood pressure (p = 0.015) were suggestive of an increase in blood pressure after consuming calcium and vitamin D supplements. Among patients who had been using calcium channel blockers, calcium and vitamin D supplementation caused a notable increase compared to baseline systolic (p = 0.019) and diastolic blood pressures (p = 0.001). The present results differ from those of previous studies. This suggests that calcium supplementation for postmenopausal women with hypertension requires the close observation of blood pressure to prevent any further increase, especially in women who are being treated with calcium channel blockers (clinicaltrial.gov registration: NCT04618952).",2022,The changes in both the mean systolic (p = 0.047) and diastolic blood pressure (p = 0.015) were suggestive of an increase in blood pressure after consuming calcium and vitamin D supplements.,"['postmenopausal women', 'postmenopausal women with hypertension', '98 women of postmenopausal age with hypertension in 2019']","['calcium channel blockers', 'calcium and vitamin D supplementation', 'calcium channel blockers, calcium and vitamin D supplementation', 'calcium supplementation', 'calcium and vitamin D supplements']","['mean systolic', 'diastolic blood pressures', 'diastolic blood pressure', 'blood pressure', 'baseline systolic']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",98.0,0.205795,The changes in both the mean systolic (p = 0.047) and diastolic blood pressure (p = 0.015) were suggestive of an increase in blood pressure after consuming calcium and vitamin D supplements.,"[{'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Sharifi', 'Affiliation': 'Cardiology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Heydarzadeh', 'Affiliation': 'Professor Kojuri Cardiology Clinic, Shiraz, Iran.'}, {'ForeName': 'Reza Golchin', 'Initials': 'RG', 'LastName': 'Vafa', 'Affiliation': 'Professor Kojuri Cardiology Clinic, Shiraz, Iran.'}, {'ForeName': 'Mohammadhossein', 'Initials': 'M', 'LastName': 'Rahmani', 'Affiliation': 'Professor Kojuri Cardiology Clinic, Shiraz, Iran.'}, {'ForeName': 'Mohammadjavad Mehdizadeh', 'Initials': 'MM', 'LastName': 'Parizi', 'Affiliation': 'Professor Kojuri Cardiology Clinic, Shiraz, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Professor Kojuri Cardiology Clinic, Shiraz, Iran.'}, {'ForeName': 'Bardia', 'Initials': 'B', 'LastName': 'Zamiri', 'Affiliation': 'Professor Kojuri Cardiology Clinic, Shiraz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Montaseri', 'Affiliation': 'Professor Kojuri Cardiology Clinic, Shiraz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Kojuri', 'Affiliation': 'Cardiology Department, Shiraz University of Medical Sciences, Shiraz, Iran. Kojurij@yahoo.com.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-022-00930-3']
1060,35567889,A multistrain probiotic improves handgrip strength and functional capacity in patients with COPD: A randomized controlled trial.,"PURPOSE


The age-related muscle loss, termed sarcopenia and functional dependency, are common findings in patients with chronic obstructive pulmonary disease (COPD). However, an effective bedside treatment remains elusive.
OBJECTIVE


To assess the effects of probiotics on sarcopenia and physical capacity in COPD patients.
METHODS


Randomized, double-blind, computer-controlled, multicenter trial in two tertiary-care hospitals for 16 weeks. A central computer system randomly allocated male, 63-73 years old COPD patients into placebo (n=53) and probiotic (n=51) groups. The intervention was Vivomix 112 billion*, one capsule a day for 16 weeks. The main outcomes measured were sarcopenia phenotype, short physical performance battery (SPPB), plasma markers of intestinal permeability (zonulin and claudin-3) and neuromuscular junction degradation (CAF22), body composition, and handgrip strength (HGS) before and following the probiotics treatment.
FINDINGS


4 patients discontinued intervention due to poor compliance and 100 patients, including placebo (n=53) and probiotic (n=47) groups were analyzed. Probiotics reduced plasma zonulin, claudin-3, and CAF22, along with an improvement in HGS, gait speed, and SPPB scores (all p<0.05). Probiotic treatment also reduced the plasma c-reactive proteins and 8-isoprostane levels, the markers of systemic inflammation and oxidative stress (p<0.05). Correlation analysis revealed varying degrees of association of plasma biomarkers with sarcopenia indexes. Despite a statistical trend, we did not find a reduction in sarcopenia prevalence in the probiotic group.
CONCLUSION


Taken together, the multistrain probiotic improves muscle strength and functional performance in COPD patients by reducing intestinal permeability and stabilizing neuromuscular junction.
TRIAL REGISTRATION


GMC clinical trial unit, GMC-CREC-00263.",2022,"Probiotic treatment also reduced the plasma c-reactive proteins and 8-isoprostane levels, the markers of systemic inflammation and oxidative stress (p<0.05).","['n=53) and probiotic (n=47) groups were analyzed', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'COPD patients', 'A central computer system randomly allocated male, 63-73 years old COPD patients into', 'two tertiary-care hospitals for 16 weeks', 'n=53) and probiotic (n=51) groups']","['multistrain probiotic', 'placebo', 'probiotics']","['muscle strength and functional performance', 'plasma zonulin, claudin-3, and CAF22', 'handgrip strength and functional capacity', 'HGS, gait speed, and SPPB scores', 'plasma c-reactive proteins and 8-isoprostane levels, the markers of systemic inflammation and oxidative stress', 'sarcopenia prevalence', 'sarcopenia phenotype, short physical performance battery (SPPB), plasma markers of intestinal permeability (zonulin and claudin-3) and neuromuscular junction degradation (CAF22), body composition, and handgrip strength (HGS', 'sarcopenia and physical capacity']","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009612', 'cui_str': 'Computer Systems'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0027869', 'cui_str': 'Neuromuscular junction'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.286295,"Probiotic treatment also reduced the plasma c-reactive proteins and 8-isoprostane levels, the markers of systemic inflammation and oxidative stress (p<0.05).","[{'ForeName': 'Asima', 'Initials': 'A', 'LastName': 'Karim', 'Affiliation': 'Basic Medical Sciences, College of Medicine, University of Sharjah, Sharjah, United Arab Emirates.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Muhammad', 'Affiliation': 'Department of Biochemistry, Gomal Medical College, Gomal University, Dera Ismail Khan, 30130, Pakistan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shahid Iqbal', 'Affiliation': 'Department of Neurology and Stroke Medicine, Rehman Medical Institute, Peshawar, 25124, Pakistan.'}, {'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Qaisar', 'Affiliation': 'Basic Medical Sciences, College of Medicine, University of Sharjah, Sharjah, United Arab Emirates. Electronic address: rqaisar@sharjah.ac.ae.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2022.104721']
1061,35063311,Promoting smoking cessation during pregnancy: A feasibility and pilot trial of a digital storytelling intervention delivered via text-messaging.,"OBJECTIVE


Smoking during pregnancy causes risks to mother and infant health. We investigated the feasibility and likely success of SKIP-IT, a narrative and picture-based smoking cessation intervention delivered via text messages.
METHODS


A feasibility and pilot trial. We aimed to recruit 70 pregnant women who smoked, randomised to usual care alone, or usual care and the SKIP-IT intervention, between 12 weeks of pregnancy and 6 weeks post due-date. Outcomes assessed were recruitment, retention, acceptability of, and engagement with the intervention, smoking behaviour, intentions, perceived risk, and self-efficacy.
RESULTS


Of 312 women initially approached by smoking cessation services only 54 (17%) agreed to be contacted by the research team. Twenty were then either ineligible or uncontactable and 28 (82%) participated. Most women reported texts to be entertaining and helpful. The proportion of women not smoking at follow-up was lower in the intervention group, but numbers were too small to draw conclusions about effectiveness.
CONCLUSION


The intervention was acceptable, but difficulty in making initial and follow-up contacts meant our methods were unfeasible for a larger trial.
PRACTICE IMPLICATIONS


Digital Storytelling interventions could help women quit smoking, but further research is required to identify alternative methods for studies with pregnant women who smoke.",2022,"Outcomes assessed were recruitment, retention, acceptability of, and engagement with the intervention, smoking behaviour, intentions, perceived risk, and self-efficacy.
","['312 women initially approached by smoking cessation services only 54 (17%) agreed to be contacted by the research team', 'pregnant women who smoke', 'Twenty were then either ineligible or uncontactable and 28 (82%) participated', '70 pregnant women who smoked, randomised to']","['usual care alone, or usual care and the SKIP-IT intervention', 'digital storytelling intervention delivered via text-messaging']","['proportion of women not smoking', 'recruitment, retention, acceptability of, and engagement with the intervention, smoking behaviour, intentions, perceived risk, and self-efficacy']","[{'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",312.0,0.0214345,"Outcomes assessed were recruitment, retention, acceptability of, and engagement with the intervention, smoking behaviour, intentions, perceived risk, and self-efficacy.
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Faculty of Health Sciences and Sport, University of Stirling, Pathfoot Building, Stirling FK9 4LA, UK. Electronic address: emma.king@stir.ac.uk.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Cheyne', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Faculty of Health Sciences and Sport, University of Stirling, Pathfoot Building, Stirling FK9 4LA, UK. Electronic address: h.l.cheyne@stir.ac.uk.'}, {'ForeName': 'Purva', 'Initials': 'P', 'LastName': 'Abhyankar', 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, Stirling FK9 4LA, UK. Electronic address: purva.abhyankar@stir.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Govan Mbeki Building, Cowcaddens Road Glasgow, G4 0BA, UK. Electronic address: andrew.elders@gcu.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Grindle', 'Affiliation': 'University of Highlands and Islands, 12B Ness Walk Inverness Inverness-Shire, IV3 5SQ, UK. Electronic address: mark.grindle@uhi.ac.uk.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hapca', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Nethergate, Dundee DD1 4HN, UK. Electronic address: a.hapca@dundee.ac.uk.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'University of Dundee Nethergate, Dundee DD1 4HN, UK. Electronic address: c.x.jones@dundee.ac.uk.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': ""O'Carroll"", 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, Stirling FK9 4LA, UK. Electronic address: reo1@stir.ac.uk.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Steele', 'Affiliation': 'School of Psychology, University of Southampton, Building 44 Highfield Campus, Southampton, SO17 1BJ, UK; Primary Care and Population Sciences, University of Southampton, Primary Medical Care Aldermoor Health Centre, Southampton SO16 5ST, UK. Electronic address: M.E.Steele@soton.ac.uk.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'School of Health, Social Care and Life Sciences, University of the Highlands and Islands, 12b Ness Walk, Inverness, Scotland, IV3 5SQ, UK; School of Health & Social Care, Edinburgh Napier University, Sighthill Court, Edinburgh, EH11 4BN, UK. Electronic address: brian.williams@uhi.ac.uk.'}]",Patient education and counseling,['10.1016/j.pec.2021.12.019']
1062,35562000,Current practice in the measurement and interpretation of intervention adherence in randomised controlled trials: A systematic review.,"BACKGROUND


Ideally all participants in a randomised controlled trial (RCT) should fully receive their allocated intervention; however, this rarely occurs in practice. Intervention adherence affects Type II error so influences the interpretation of trial results and subsequent implementation. We aimed to describe current practice in the definition, measurement, and reporting of intervention adherence in non-pharmacological RCTs, and how this data is incorporated into a trial's interpretation and conclusions.
METHODS


We conducted a systematic review of phase III RCTs published between January 2018 and June 2020 in the National Institute for Health Research Journals Library for the Health Technology Assessment, Programme Grants for Applied Research, and Public Health Research funding streams.
RESULTS


Of 237 reports published, 76 met the eligibility criteria and were included. Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis. Adherence measures varied between intervention types: behavioural change (n = 10, 43.5%), psychological therapy (n = 5, 83.3%) and physiotherapy/rehabilitation (n = 8, 66.7%) interventions predominately measured adherence based on session attendance. Whereas medical device and surgical interventions (n = 17, 73.9%) primarily record the number of participants receiving the allocated intervention, a third (n = 33, 67.3%) of studies reported a difference in findings between primary and sensitivity analyses.
CONCLUSIONS


Although most trials report elements of adherence, terminology was inconsistent, and there was no systematic approach to its measurement, analyses, interpretation, or reporting. Given the importance of adherence within clinical trials, there is a pressing need for a standardised approach or framework.",2022,"Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis.","['Of 237 reports published, 76 met the eligibility criteria and were included', 'phase III RCTs published between January 2018 and June 2020 in the National Institute for Health Research Journals Library for the Health Technology Assessment, Programme Grants for Applied Research, and Public Health Research funding streams']",['psychological therapy'],[],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0023621', 'cui_str': 'Library'}, {'cui': 'C0039423', 'cui_str': 'Assessment, Biomedical Technology'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0376244', 'cui_str': 'funding'}, {'cui': 'C0442540', 'cui_str': 'Stream'}]","[{'cui': 'C0841584', 'cui_str': 'Psychological therapies'}]",[],,0.23019,"Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis.","[{'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Giovanazzi', 'Affiliation': 'Department of Health Sciences, University of York, York, UK; Department of Diagnostics and Public Health, University of Verona, Italy.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Carr', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Backhouse', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, UK.'}, {'ForeName': 'Joy A', 'Initials': 'JA', 'LastName': 'Adamson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK. Electronic address: joy.adamson@york.ac.uk.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106788']
1063,35561963,"Electrical stimulation of the trigeminal nerve improves olfaction in healthy individuals: A randomized, double-blind, sham-controlled trial.","BACKGROUND


Both activated by environmental odorants, there is a clear role for the intranasal trigeminal and olfactory nerves in smell function. Unfortunately, our ability to perceive odorants decreases with age or with injury, and limited interventions are available to treat smell loss.
OBJECTIVE


We investigated whether electrical stimulation of the trigeminal nerve via trigeminal nerve stimulation (TNS) or transcranial direct current stimulation (tDCS) modulates odor sensitivity in healthy individuals.
METHODS


We recruited 20 healthy adults (12 Female, mean age = 27) to participate in this three-visit, randomized, double-blind, sham-controlled trial. Participants were randomized to receive one of three stimulation modalities (TNS, tDCS, or sham) during each of their visits. Odor detection thresholds were obtained at baseline, immediately post-intervention, and 30-min post-intervention. Furthermore, participants were asked to complete a sustained attention task and mood assessments before odor detection testing.
RESULTS


Findings reveal a timeXcondition interaction for guaiacol (GUA) odorant detection thresholds (F (3.188, 60.57) = 3.833, P = 0.0125), but not phenyl ethyl alcohol (PEA) odorant thresholds. At 30-min post-stimulation, both active TNS and active tDCS showed significantly increased sensitivity to GUA compared to sham TNS (Sham TNS = -8.30% vs. Active TNS = 9.11%, mean difference 17.43%, 95% CI 5.674 to 29.18, p = 0.0044; Sham TNS = -8.30% vs. Active tDCS = 13.58%, mean difference 21.89%, 95% CI 10.47 to 33.32, p = 0.0004).
CONCLUSION


TNS is a safe, simple, noninvasive method for boosting olfaction. Future studies should investigate the use of TNS on smell function across different stimulation parameters, odorants, and patient populations.",2022,"At 30-min post-stimulation, both active TNS and active tDCS showed significantly increased sensitivity to GUA compared to sham TNS (Sham TNS = -8.30% vs. Active TNS = 9.11%, mean difference 17.43%, 95% CI 5.674 to 29.18, p = 0.0044:","['20 healthy adults (12 Female, mean age\u202f=\u202f27', 'healthy individuals']","['stimulation modalities (TNS, tDCS, or sham', 'TNS', 'trigeminal nerve via trigeminal nerve stimulation (TNS) or transcranial direct current stimulation (tDCS']",['sensitivity to GUA'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018304', 'cui_str': 'Guaiacol'}]",20.0,0.687798,"At 30-min post-stimulation, both active TNS and active tDCS showed significantly increased sensitivity to GUA compared to sham TNS (Sham TNS = -8.30% vs. Active TNS = 9.11%, mean difference 17.43%, 95% CI 5.674 to 29.18, p = 0.0044:","[{'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Georgia H', 'Initials': 'GH', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Chris W', 'Initials': 'CW', 'LastName': 'Austelle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Alex T', 'Initials': 'AT', 'LastName': 'Kahn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'McTeague', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Uhde', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bernadette M', 'Initials': 'BM', 'LastName': 'Cortese', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA. Electronic address: corteseb@musc.edu.'}]",Brain stimulation,['10.1016/j.brs.2022.05.005']
1064,35562327,A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non-small cell lung cancer harboring EGFR mutations (JMTO LC12-01).,"BACKGROUND


Gefitinib (G) is a recommended molecular-targeted agent for elderly patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). Docetaxel (Doc) and pemetrexed (Pem) have similar efficacies, and either is often used as the sole agent during treatment. The efficacy of continuing G after progressive disease (PD) develops has been reported. It remains unclear whether the continuation of G in combination with a single cytotoxic agent beyond PD is beneficial for elderly patients. Here, we conducted a randomized phase II study to assess the efficacy and safety of cytotoxic chemotherapy with G for elderly patients with progressive EGFR-mutant NSCLC.
METHODS


Elderly patients with EGFR-mutant NSCLC with PD previously treated with G were enrolled. Patients received Pem 500 mg/m or Doc 60 mg/m every 21 days and were randomly assigned to receive chemotherapy with 250 mg G (G+ Doc/Pem arm) or without G (Doc/Pem arm) until further disease progression or unacceptable toxicity.
RESULTS


This trial was terminated early owing to slow accrual. A group of 22 patients underwent analysis. The primary endpoint, progression-free survival (PFS), was significantly longer in the G + Doc/Pem arm (median: 1.6 months vs. 5.6 months, hazard ratio = 0.40, 95% CI: 0.16-0.99, p = 0.0391). Adverse events ≥ grade 3 were more frequent in the G + Doc/Pem arm (45.5% vs. 90.9%, p = 0.032).
CONCLUSIONS


Patients on G and Pem or Doc beyond PD showed a longer PFS than those on single-agent chemotherapy; however, it was associated with increased toxicity.",2022,"The primary endpoint, progression-free survival (PFS), was significantly longer in the G + Doc/Pem arm (median:","['elderly patients with non-small cell lung cancer harboring EGFR mutations (JMTO LC12-01', 'elderly patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC', 'elderly patients', 'elderly patients with progressive EGFR-mutant NSCLC.\nMETHODS\n\n\nElderly patients with EGFR-mutant NSCLC with PD previously treated with G were enrolled', '22 patients underwent analysis']","['Pem 500\u2009mg/m or Doc 60\u2009mg/m every 21\u2009days and were randomly assigned to receive chemotherapy with 250\u2009mg\u2009G (G+ Doc/Pem arm) or without G', 'Gefitinib (G', 'gefitinib', 'docetaxel or pemetrexed', 'Docetaxel (Doc) and pemetrexed (Pem', 'cytotoxic chemotherapy with G']","['efficacy and safety', 'toxicity', 'progression-free survival (PFS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0791295,"The primary endpoint, progression-free survival (PFS), was significantly longer in the G + Doc/Pem arm (median:","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Asami', 'Affiliation': 'Asami Naika Clinic, Tokyo, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'Department of Respiratory Medicine, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yokoi', 'Affiliation': 'Department of Thoracic Oncology, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Atsuhisa', 'Initials': 'A', 'LastName': 'Tamura', 'Affiliation': 'Department of Center for Pulmonary Diseases, Tokyo National Hospital, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Minato', 'Affiliation': 'Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Gunma, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, Osaka, Japan.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Ogushi', 'Affiliation': 'Department of Respiratory Medicine, Kochi National Hospital, Kochi, Japan.'}, {'ForeName': 'Akiyoshi', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Respiratory Medicine, Takamatsu Red Cross Hospital, Kagawa, Japan.'}, {'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Kawahara', 'Affiliation': 'Department of Respiratory Medicine, KKR Otemae Hospital, Osaka, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}]",Thoracic cancer,['10.1111/1759-7714.14465']
1065,35568193,"The efficacy of single-lead implantable cardioverter-defibrillator with atrial sensing dipole to detect atrial fibrillation and to reduce inappropriate therapy according to atrial sensing ON or OFF: Rationale and design of the SMART-CONTROL study, a prospective multicenter randomized trial.","BACKGROUND


Few studies have compared the efficacy of single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (VDD-ICD) and conventional single-chamber ICD from the aspect of atrial fibrillation (AF) detection or inappropriate ICD therapy reduction. In the SMART-CONTROL trial (NCT03932604), we primarily aim to investigate whether the atrial sensing capability of VDD-ICD is useful in AF detection and inappropriate therapy reduction by randomly activating or deactivating the atrial sensing function.
METHODS AND DESIGN


This study was designed as a prospective, multicenter, open-label, randomized trial to enroll 640 patients with no history of clinical AF or rhythm control for AF within 1 year who were undergoing the implantation of VDD-ICD system. Patients are assigned randomly to atrial sensing ""ON"" or ""OFF"" group, with crossover allowed during follow-up. The coprimary outcomes are the incidence of AF detection and inappropriate ICD therapy over a 2-year follow-up period. The secondary outcomes include non-AF atrial tachyarrhythmia, ventricular tachyarrhythmia with or without ICD therapy, thromboembolic events, bleeding, heart failure hospitalization, mortality, a composite of adverse cardiovascular events, and long-term atrial sensing stability or variability.
CONCLUSION


We expect that this trial can evaluate the efficacy of a single-lead ICD system on various clinical outcomes including AF detection and inappropriate therapy reduction, and ultimately provide guidance to selection of ICD system.",2022,The co-primary outcomes are the incidence of AF detection and inappropriate ICD therapy over a 2-year follow-up period.,['640 patients with no history of clinical AF or rhythm control for AF within one year who were undergoing the implantation of VDD-ICD system'],"['single-lead ICD system', 'single-lead implantable cardioverter-defibrillator', 'single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (VDD-ICD) and conventional single-chamber ICD']","['non-AF atrial tachyarrhythmia, ventricular tachyarrhythmia with or without ICD therapy, thromboembolic events, bleeding, heart failure hospitalization, mortality, a composite of adverse cardiovascular events, and long-term atrial sensing stability or variability', 'incidence of AF detection and inappropriate ICD therapy']","[{'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}]",640.0,0.0665837,The co-primary outcomes are the incidence of AF detection and inappropriate ICD therapy over a 2-year follow-up period.,"[{'ForeName': 'Hye Bin', 'Initials': 'HB', 'LastName': 'Gwag', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.'}, {'ForeName': 'Hye Ree', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: orthovics@gmail.com.'}, {'ForeName': 'Juwon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Wan', 'Initials': 'TW', 'LastName': 'Chung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Hoon', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ju Youn', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung-Min', 'Initials': 'KM', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Keun', 'Initials': 'YK', 'LastName': 'On', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'June Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",American heart journal,['10.1016/j.ahj.2022.05.008']
1066,35569230,"Efficacy of individualized homeopathy as an adjunct to standard of care of COVID-19: A randomized, single-blind, placebo-controlled study.",,2022,,[],"['placebo', 'individualized homeopathy']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}]",[],,0.085633,,"[{'ForeName': 'Debadatta', 'Initials': 'D', 'LastName': 'Nayak', 'Affiliation': 'Epidemic Cell, Central Council for Research in Homoeopathy, 61-65, Institutional Area, Janakpuri, New Delhi, 110058, India. Electronic address: drdnayak@gmail.com.'}, {'ForeName': 'Juhi', 'Initials': 'J', 'LastName': 'Gupta', 'Affiliation': 'Dept. of Physiology, Government Homoeopathic Medical College and Hospital, AYUSH Campus, MACT Hills, Kaliasot Dam Approach Rd, Chuna Bhatti, Bhopal, Madhya Pradesh, 462003, India.'}, {'ForeName': 'Anupriya', 'Initials': 'A', 'LastName': 'Chaudhary', 'Affiliation': 'Dept. of Clinical Research, Central Council for Research in Homoeopathy, 61-65, Institutional Area, Janakpuri, New Delhi, 110058, India.'}, {'ForeName': 'Krishna Gopal', 'Initials': 'KG', 'LastName': 'Singh', 'Affiliation': 'Dept. of Pulmonary Medicine, Chirayu Medical College & Hospital. Bhopal-Indore Highway Bhainsakhedi, Bairagarh, Bhopal, Madhya Pradesh, 462030, India.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Deshmukh', 'Affiliation': 'Dept. of Surgery, Chirayu Medical College & Hospital, Bhopal-Indore Highway Bhainsakhedi, Bairagarh, Bhopal, Madhya Pradesh, 462030, India.'}, {'ForeName': 'Deblina', 'Initials': 'D', 'LastName': 'Das', 'Affiliation': 'Epidemic Cell, Central Council for Research in Homoeopathy, 61-65, Institutional Area, Janakpuri, New Delhi, 110058, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Saha', 'Affiliation': 'Intermediary Pharmacovigilance Centre (Homoeopathy), National Institute of Homoeopathy, GE Block, Sector-III, Salt Lake, Kolkata, 700106, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Epidemic Cell, Central Council for Research in Homoeopathy, 61-65, Institutional Area, Janakpuri, New Delhi, 110058, India.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Epidemic Cell, Central Council for Research in Homoeopathy, 61-65, Institutional Area, Janakpuri, New Delhi, 110058, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Goenka', 'Affiliation': 'Chirayu Medical College & Hospital, Bhopal-Indore Highway Bhainsakhedi, Bairagarh, Bhopal, Madhya Pradesh, 462030, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mishra', 'Affiliation': 'Government Homoeopathic Medical College and Hospital, AYUSH Campus, MACT Hills, Kaliasot Dam Approach Rd, Chuna Bhatti, Bhopal, Madhya Pradesh, 462003, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Dept. of Practice of Medicine, Government Homoeopathic Medical College and Hospital, AYUSH Campus, MACT Hills, Kaliasot Dam Approach Rd, Chuna Bhatti, Bhopal, Madhya Pradesh, 462003, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Khurana', 'Affiliation': 'Central Council for Research in Homoeopathy, 61-65, Institutional Area, Janakpuri, New Delhi, 110058, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2022.101602']
1067,35569575,Neuroplastic changes in anterior cingulate cortex gray matter volume and functional connectivity following attention bias modification in high trait anxious individuals.,"Attention bias modification (ABM) was developed to alleviate anxious symptoms by way of a reduction in anxiety-linked attentional bias to threat. Central to the rational of ABM is a learning-related reconfiguration of attentional biases. Yet, the neuroplastic changes in brain structure that underlie this learning are unresolved. The amygdala, anterior cingulate cortex, and lateral prefrontal cortex are part of a system linked to attentional bias to threat and its modification with ABM. We assessed the extent to which ABM modulates gray matter volume and resting-state functional connectivity. Sixty-one individuals selected for attentional bias to threat and heightened trait anxiety completed a 6-week multi-session ABM protocol with 7200 total training trials. Participants were assigned to either an ABM (n = 30) or a control (n = 31) condition. We found that participants' levels of attentional bias and anxiety did not differ following ABM and control training interventions. However, the ABM group displayed greater levels of anterior cingulate cortex gray matter volume as well as greater superior frontal gyrus resting-state functional connectivity with the anterior cingulate cortex and insula. Changes in anterior cingulate cortex gray matter volume were linked to reduced anxious symptoms in the ABM, but not control, group. These findings suggest that ABM distinctively impacts structural and functional neural mechanisms associated with emotion reactivity and cognitive control processes.",2022,"Changes in anterior cingulate cortex gray matter volume were linked to reduced anxious symptoms in the ABM, but not control, group.",['high trait anxious individuals'],"['Attention bias modification (ABM', 'ABM']","['anterior cingulate cortex gray matter volume', 'attentional bias to threat and heightened trait anxiety', 'attentional bias and anxiety', 'anxious symptoms']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",61.0,0.0310516,"Changes in anterior cingulate cortex gray matter volume were linked to reduced anxious symptoms in the ABM, but not control, group.","[{'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Carlson', 'Affiliation': 'Department of Psychological Science, Northern Michigan University, Marquette, MI, USA. Electronic address: joshcarl@nmu.edu.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Department of Psychological Science, Northern Michigan University, Marquette, MI, USA.'}, {'ForeName': 'Ernst H W', 'Initials': 'EHW', 'LastName': 'Koster', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Andrzejewski', 'Affiliation': 'Department of Psychological Science, Northern Michigan University, Marquette, MI, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Psychological Science, Northern Michigan University, Marquette, MI, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Elwell', 'Affiliation': 'Department of Psychological Science, Northern Michigan University, Marquette, MI, USA.'}, {'ForeName': 'Taylor R', 'Initials': 'TR', 'LastName': 'Zuidema', 'Affiliation': 'Department of Psychological Science, Northern Michigan University, Marquette, MI, USA.'}]",Biological psychology,['10.1016/j.biopsycho.2022.108353']
1068,35040415,Effects of Hydroxychloroquine on Progression of Diabetic Retinopathy in Subjects with Rheumatoid Arthritis and Type 2 Diabetes Mellitus.,"OBJECTIVE


The study was conducted to investigate the effects of hydroxychloroquine, an anti-inflammatory drug, which was recently approved and used as an add on oral antidiabetic drug for uncontrolled Type 2 Diabetes Mellitus (DM) on an adequate dose of sulfonylurea and metformin on the progression of diabetic retinopathy (DR) in subjects with Rheumatoid Arthritis and Type 2 Diabetes Mellitus. The primary objective was to evaluate the effect of hydroxychloroquine on the onset of Diabetic Retinopathy (DR) and progression of the disease. Best-corrected visual acuity (BCVA) charts with 3 or more lines worsening of visual acuity and the development of clinically significant macular edema (CSME) were added as secondary objectives as described in the Early Treatment Diabetic Retinopathy Study (ETDRS).
METHODS


This retrospective analysis was done from medical records of all Rheumatoid Arthritis (RA) patients who also had T2DM and were treated with hydroxychloroquine (HCQ) 400 mg OD or 200 mg BID (N=65) and received ophthalmologic care at an endocrinology clinic in India up to a mean follow-up of 3.5±0.5 years and matched subjects taking any other disease-modifying antirheumatic drugs (DMARD) and pioglitazone (N=34).
RESULTS


Baseline characteristics were similar in both the groups, with matched glycated haemoglobin (9.1 % and 9.2 % respectively, p=0.127). In both groups, over 3.5 years, HbA1c was reduced significantly. No new cases of DR were detected in the HCQ group, whereas 2 patients had developed DR in the pioglitazone group. At the base line visit, mild non-proliferative Diabetic Retinopathy (NPDR) was present in 18 eyes and 14 eyes in the HCQ and pioglitazone groups, respectively. Progression to moderate NPDR over 3.5 years occurred in 2 out of 18 (11 %) eyes in the HCQ group and 8 out of 14 (57 %) eyes in the pioglitazone group, respectively, representing a significant relative risk reduction (p=.001). No patients had progressed from mild NPDR to severe NPDR in the HCQ group, whereas 2 eyes had progressed from mild NPDR to severe NPDR in the pioglitazone group. None of the patients in either arm developed diabetic macular oedema.
CONCLUSION


Progression of DR from mild to moderate NPDR or severe NPDR may be delayed by HCQ. Large scale randomised prospective clinical trial is required to establish the risk-benefit profiles of HCQ in T2DM.ct.",2022,"Progression to moderate NPDR over 3.5 years occurred in 2 out of 18 (11%) eyes in HCQ group and 8 out of 14 (57%) eyes in the pioglitazone group, respectively representing a significant relative risk reduction (P=.001).","['medical records of all Rheumatoid Arthritis (RA) patients who also had T2DM and treated with', 'N=34', 'uncontrolled Type 2 Diabetes Mellitus (DM', 'or 200 mg BID (N=65) and received', 'subjects with Rheumatoid Arthritis and Type 2 Diabetes Mellitus', 'Subjects with Rheumatoid Arthritis and Type 2 Diabetes Mellitus']","['ophthalmologic care at an endocrinology clinic in India up to a mean follow-up of 3.5±0.5 years and matched subjects taking any other disease-modifying antirheumatic drugs (DMARD) and pioglitazone', 'sulfonylurea and metformin', 'hydroxychloroquine', 'hydroxychloroquine (HCQ) 400 mg OD', 'pioglitazone', 'Hydroxychloroquine']","['Diabetic Retinopathy (DR) and progression of the disease', 'glycated haemoglobin', 'diabetic macular oedema', 'Progression to moderate NPDR', 'proliferative Diabetic Retinopathy (NPDR', 'Progression of Diabetic Retinopathy', 'mild NPDR to severe NPDR', 'mild NDPR to severe NPDR']","[{'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C3810855', 'cui_str': 'Endocrinology clinic'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0730277', 'cui_str': 'Moderate nonproliferative diabetic retinopathy'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0004606', 'cui_str': 'Nonproliferative diabetic retinopathy'}, {'cui': 'C0730276', 'cui_str': 'Mild nonproliferative diabetic retinopathy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",,0.0864589,"Progression to moderate NPDR over 3.5 years occurred in 2 out of 18 (11%) eyes in HCQ group and 8 out of 14 (57%) eyes in the pioglitazone group, respectively representing a significant relative risk reduction (P=.001).","[{'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Baidya', 'Affiliation': 'Department of Endocrinology, NRS Medical College and Hospital, Kolkata, WB, India.'}]",Current diabetes reviews,['10.2174/1573399818666220118101320']
1069,35042630,Anxiety in Parkinson's disease: A resting-state high density EEG study.,"OBJECTIVE


To identify markers of Parkinson's disease (PD) related anxiety, using high density electroencephalography (hd-EEG).
METHODS


108 patients participated in the study. They were divided into two groups: with and without clinically relevant anxiety, according to their score on the Parkinson Anxiety Scale. Resting-state hd-EEG was recorded. Spectral and functional connectivity characteristics were compared between the two groups.
RESULTS


Thirty-three patients (31%) had significant anxiety symptoms. In the spectral analysis, relative power in the alpha1 frequency band in the right prefrontal cortex was lower in patients with anxiety than without. Functional connectivity analysis showed a stronger connectivity between the left insula and several regions of the right prefrontal cortex in patients with anxiety than in those without.
CONCLUSION


This study shows the pivotal role of the insula and frontal cortex in the pathophysiology of anxiety in PD and extends the results of previous studies using magnetic resonance imaging or positron emission tomography imaging.",2022,"In the spectral analysis, relative power in the alpha1 frequency band in the right prefrontal cortex was lower in patients with anxiety than without.","[""Anxiety in Parkinson's disease"", '108 patients participated in the study', 'patients with anxiety than in those without']",['magnetic resonance imaging or positron emission tomography imaging'],"['Spectral and functional connectivity characteristics', 'anxiety symptoms', 'Parkinson Anxiety Scale']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",108.0,0.0218779,"In the spectral analysis, relative power in the alpha1 frequency band in the right prefrontal cortex was lower in patients with anxiety than without.","[{'ForeName': 'Nacim', 'Initials': 'N', 'LastName': 'Betrouni', 'Affiliation': 'Univ. Lille, INSERM, CHU Lille, U1172, Degenerative & Vascular Cognitive Disorders, F-59000 Lille, France. Electronic address: nacim.betrouni@inserm.fr.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Alazard', 'Affiliation': 'Univ. Lille, INSERM, CHU Lille, U1172, Degenerative & Vascular Cognitive Disorders, F-59000 Lille, France.'}, {'ForeName': 'Madli', 'Initials': 'M', 'LastName': 'Bayot', 'Affiliation': 'Univ. Lille, INSERM, CHU Lille, U1172, Degenerative & Vascular Cognitive Disorders, F-59000 Lille, France; CHU Lille, Clinical Neurophysiology Department, F-59000 Lille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Carey', 'Affiliation': 'Univ. Lille, INSERM, CHU Lille, U1172, Degenerative & Vascular Cognitive Disorders, F-59000 Lille, France; CHU Lille, Neurology and Movement Disorders Department, F-59000 Lille, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Derambure', 'Affiliation': 'Univ. Lille, INSERM, CHU Lille, U1172, Degenerative & Vascular Cognitive Disorders, F-59000 Lille, France; CHU Lille, Clinical Neurophysiology Department, F-59000 Lille, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defebvre', 'Affiliation': 'Univ. Lille, INSERM, CHU Lille, U1172, Degenerative & Vascular Cognitive Disorders, F-59000 Lille, France; CHU Lille, Neurology and Movement Disorders Department, F-59000 Lille, France.'}, {'ForeName': 'Albert Fg', 'Initials': 'AF', 'LastName': 'Leentjens', 'Affiliation': 'Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Delval', 'Affiliation': 'Univ. Lille, INSERM, CHU Lille, U1172, Degenerative & Vascular Cognitive Disorders, F-59000 Lille, France; CHU Lille, Clinical Neurophysiology Department, F-59000 Lille, France.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Dujardin', 'Affiliation': 'Univ. Lille, INSERM, CHU Lille, U1172, Degenerative & Vascular Cognitive Disorders, F-59000 Lille, France; CHU Lille, Neurology and Movement Disorders Department, F-59000 Lille, France.'}]",Neurophysiologie clinique = Clinical neurophysiology,['10.1016/j.neucli.2022.01.001']
1070,35051670,A randomized controlled trial of sleep study surveillance with targeted autoregulated positive airway pressure therapy for obstructive sleep apnea in pregnancy.,"BACKGROUND


Obstructive sleep apnea is associated with adverse pregnancy outcomes. The impact therapy for obstructive sleep apnea has on these pregnancy outcomes remains under investigated.
OBJECTIVE


This study aimed to determine the effects of targeted autoregulated positive airway pressure in women at risk of obstructive sleep apnea on adverse pregnancy outcomes, cost, and natural history of obstructive sleep apnea.
STUDY DESIGN


Pregnant women at high risk of obstructive sleep apnea were randomized to either a sleep study screening group receiving autoregulated positive airway therapy or a group not screened for obstructive sleep apnea receiving standard obstetrical care (control). Women in the sleep study-screened group received a sleep study at 2 periods during pregnancy, early (6-16 weeks of gestation) and late (27-33 weeks of gestation), with initiation of autoregulated positive airway therapy if their Apnea Hypopnea Index indicated ≥5 events per hour. Women of both groups had a sleep study 3 months after delivery. The primary outcome was effect on adverse pregnancy outcomes, a composite of hypertension, preterm birth, low birthweight, stillbirth, and diabetes mellitus. The secondary outcomes included obstructive sleep apnea severity and hospital costs.
RESULTS


Among 193 women randomized (100 in the sleep study-screened group and 93 in the control group; 6 lost to follow-up), there was no significant difference in composite adverse pregnancy outcomes (46.4% screened vs 43.3% control; P=.77), hypertension (23.7% screened vs 32.0% control; P=.25), preterm birth (13.4% screened vs 10.0% control; P=.5), low birthweight (5.2% screened vs 6.7% control; P=.76), stillbirth (1% screened vs 0% control; P=1), gestational diabetes (19.6% screened vs 13.3% control; P=.33), or mean cost ($12,185 screened vs $12,607 control). The Apnea Hypopnea Index increased throughout pregnancy, peaking at 3 months after delivery (P<.001). There were 24 subjects (25.8%) who had a new diagnosis of obstructive sleep apnea, with 6 in whom autoregulated positive airway was prescribed. The autoregulated positive airway compliance rates were poor with usage rates ranging from 2% (1 of 64 days) to 43% (6 of 14 days).
CONCLUSION


Targeted autoregulated positive airway therapy for obstructive sleep apnea did not decrease composite adverse pregnancy outcomes or hospital costs in the sleep study-screened high-risk pregnancy group compared with the group that received no obstructive sleep apnea screening. However, a small sample size, low autoregulated positive airway prescription rates, and poor compliance resulted in difficulty in drawing a definitive conclusion. The prevalence and severity of obstructive sleep apnea worsened throughout pregnancy, with the highest rates detected in the postpartum period. Large, multicenter clinical trials that are adequately powered are needed.",2022,"The AHI increased over the course of pregnancy, peaking at 3 months postpartum (p<.001). ","['Obstructive Sleep Apnea in Pregnancy', 'There were 24 (25.8%) subjects who had a new diagnosis of OSA, with 6 in whom APAP was prescribed', 'Pregnant women at high risk for OSA', '193 women randomized (100 sleep study screened group; 93 control group', 'women at risk for obstructive sleep apnea (OSA']","['targeted autoregulated positive airway pressure (APAP', 'Targeted APAP Therapy', 'sleep study screening group with possible initiation of APAP compared to women not screened for OSA, receiving standard obstetric care (control', 'APAP therapy']","['adverse pregnancy outcomes (APOs), cost, and natural history of OSA', 'hypertension', 'OSA severity and hospital costs', 'prevalence and severity of OSA', 'stillbirth', 'mean cost', 'APAP compliance rates', 'low birthweight', 'APO, a composite of hypertension, preterm birth, low birthweight, stillbirth and diabetes', 'composite adverse pregnancy outcomes or hospital costs', 'preterm birth', 'gestational diabetes', 'composite APO']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]",193.0,0.126506,"The AHI increased over the course of pregnancy, peaking at 3 months postpartum (p<.001). ","[{'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Kalkhoff', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA; Department of Gynecologic Surgery and Obstetrics, US Naval Hospital, Yokosuka, Japan. Electronic address: stephen.m.kalkhoff.mil@mail.mil.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'Lutgendorf', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Morrison', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Spence', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100571']
1071,35051978,Effect of Varying Repositioning Frequency on Pressure Injury Prevention in Nursing Home Residents: TEAM-UP Trial Results.,"OBJECTIVE


To investigate the clinical effectiveness of three nursing-home-wide repositioning intervals (2-, 3-, or 4-hour) without compromising pressure injury (PrI) incidence in 4 weeks.
METHODS


An embedded pragmatic cluster randomized controlled trial was conducted in nine nursing homes (NHs) that were randomly assigned to one of three repositioning intervals. Baseline (12 months) and 4-week intervention data were provided during the TEAM-UP (Turn Everyone And Move for Ulcer Prevention) study. Intervention residents were without current PrIs, had PrI risk (Braden Scale score) ≥10 (not severe risk), and used viable 7-inch high-density foam mattresses. Each arm includes three NHs with an assigned single repositioning interval (2-, 3-, or 4-hour) as standard care during the intervention. A wireless patient monitoring system, using wearable single-use patient sensors, cued nursing staff by displaying resident repositioning needs on conveniently placed monitors. The primary outcome was PrI incidence; the secondary outcome was staff repositioning compliance fidelity.
RESULTS


From May 2017 to October 2019, 1,100 residents from nine NHs were fitted with sensors; 108 of these were ineligible for some analyses because of missing baseline data. The effective sample size included 992 residents (mean age, 78 ± 13 years; 63% women). The PrI incidence during the intervention was 0.0% compared with 5.24% at baseline, even though intervention resident clinical risk scores were significantly higher (P < .001). Repositioning compliance for the 4-hour repositioning interval (95%) was significantly better than for the 2-hour (80%) or 3-hour (90%) intervals (P < .001).
CONCLUSIONS


Findings suggest that current 2-hour protocols can be relaxed for many NH residents without compromising PrI prevention. A causal link was not established between repositioning interval treatments and PrI outcome; however, no new PrIs developed. Compliance improved as repositioning interval lengthened.",2022,"Repositioning compliance for 4-hour repositioning interval (95%) was significantly better than 2- (80%) or 3- (90%) hours (P < .001).
","['992 residents (mean age 78 ± 13 years; 63% women', 'Eleven hundred residents from 9 NHs were fitted with sensors; 108 of these were ineligible for some analyses because of missing baseline data', 'nine nursing homes (NH', 'Nursing Home Residents']",['Varying Repositioning Frequency'],"['Pressure Injury Prevention', 'current PIs, had PI risk (Braden Scale score', 'Repositioning compliance', 'intervention risk scores', 'PI incidence; the secondary outcome was staff repositioning compliance fidelity', 'PI incidence']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",1100.0,0.268515,"Repositioning compliance for 4-hour repositioning interval (95%) was significantly better than 2- (80%) or 3- (90%) hours (P < .001).
","[{'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Yap', 'Affiliation': 'Tracey L. Yap, PhD, RN, CNE, WCC, FGSA, FAAN, is Associate Professor, Duke University School of Nursing, Durham, North Carolina, United States. Susan D. Horn, PhD, is Adjunct Professor, University of Utah School of Medicine, Salt Lake City. Phoebe D. Sharkey, PhD, is Professor Emeritus, Loyola University Maryland, Baltimore. Tianyu Zheng, MS, is Research Assistant, University of Utah Department of Population Health Sciences. Nancy Bergstrom, PhD, RN, FAAN, is Professor Emeritus, University of Texas Health Science Center at Houston School of Nursing. Cathleen Colon-Emeric, MD, is Professor, Duke University School of Medicine. Valerie K. Sabol, PhD, MBA, ACNP, GNP, FAANP, FAAN, is Professor, Duke University School of Nursing. Jenny Alderden, PhD, APRN, is Associate Professor, Boise State University School of Nursing, Idaho. Winston Yap, MD, Carroll County Memorial Hospital, Carrollton, Kentucky. Susan M. Kennerly, PhD, RN, CNE, WCC, FAAN, is Professor, East Carolina University College of Nursing, Greenville, North Carolina. Acknowledgments: The authors thank Judith Hayes, PhD, RN, and Elizabeth Flint, PhD, for editorial assistance. This project was funded by the National Institutes of Health, National Institute of Nursing Research (R01NR016001; Yap, principal investigator). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors have disclosed no other financial relationships related to this article. Submitted December 5, 2021; accepted December 23, 2021; published online ahead of print January 19, 2022.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Phoebe D', 'Initials': 'PD', 'LastName': 'Sharkey', 'Affiliation': ''}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bergstrom', 'Affiliation': ''}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Colon-Emeric', 'Affiliation': ''}, {'ForeName': 'Valerie K', 'Initials': 'VK', 'LastName': 'Sabol', 'Affiliation': ''}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Alderden', 'Affiliation': ''}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Yap', 'Affiliation': ''}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kennerly', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000817840.68588.04']
1072,35063464,Medium-term Clinical Efficacy and Complications of Plasmakinetic Enucleation of the Prostate Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia.,"OBJECTIVE


To compare surgical characteristics, clinical efficacy, and complications of plasmakinetic enucleation of the prostate (PKEP) and transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS


From January 2015 to May 2018, 370 patients underwent TURP were included into the TURP group. Meanwhile, another 370 patients underwent PKEP (matched by age, prostate volume, and duration of BPH) were included into the PKEP group. Then, the differences of surgical characteristics, clinical efficacy, and complications were compared between the two groups.
RESULTS


The operative time, intraoperative irrigation volume, postoperative irrigation time and irrigation volume, drop in hemoglobin, blood transfusion, postoperative catheterization time, and hospital stay of the PKEP group were significantly less than those of the TURP group (P <.05). No significant differences were observed in the resected tissue weight, visual analogue scale score, and total cost of hospitalization (P >.05); The quality of life score of the PKEP group was significantly lower than that of the TURP group (P <.05). No significant differences of maximum flow rate, postvoid residual urine, Serum prostate-specific antigen, international prostate symptom score and International Index of Erectile Function score were observed (P >.05); The incidences of urinary tract irritation, massive hemorrhage, secondary hemorrhage, bladder spasm, clot retention, and retrograde ejaculation of the PKEP group were significantly lower than those of the TURP group (P <.05).
CONCLUSION


PKEP and TURP are comparable regarding cost burden and clinical efficacy in medium-term follow-up. However, PKEP should be given a priority for BPH treatment because of less complication rate and better safety profile.",2022,"No significant differences were observed in the resected tissue weight, VAS score, and total cost of hospitalization (P > 0.05); The QoL score of the PKEP group was significantly lower than that of the TURP group (P < 0.05).","['370 patients underwent PKEP (matched by age, prostate volume, and duration of BPH) were included into the PKEP group', 'Benign Prostatic Hyperplasia', 'benign prostatic hyperplasia (BPH', 'From January 2015 to May 2018, 370 patients underwent TURP were included into the TURP group']","['plasmakinetic enucleation of the prostate (PKEP) and transurethral resection of the prostate (TURP', 'TURP', 'PKEP and TURP', 'Plasmakinetic Enucleation of the Prostate Versus Transurethral Resection', 'PKEP']","['surgical characteristics, clinical efficacy, and complications', 'incidences of urinary tract irritation, massive hemorrhage, secondary hemorrhage, bladder spasm, clot retention, and retrograde ejaculation', 'complication rate', 'QoL score', 'resected tissue weight, VAS score, and total cost of hospitalization', 'Q max , PVR, Serum PSA, IPSS score and IIEF score', 'operative time, intraoperative irrigation volume, postoperative irrigation time and irrigation volume, drop in hemoglobin, blood transfusion, postoperative catheterization time, and hospital stay']","[{'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0333279', 'cui_str': 'Massive hemorrhage'}, {'cui': 'C0347697', 'cui_str': 'Secondary hemorrhage'}, {'cui': 'C0426390', 'cui_str': 'Spasm of bladder'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0403673', 'cui_str': 'Retrograde ejaculation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0376516,"No significant differences were observed in the resected tissue weight, VAS score, and total cost of hospitalization (P > 0.05); The QoL score of the PKEP group was significantly lower than that of the TURP group (P < 0.05).","[{'ForeName': 'Bin-Bin', 'Initials': 'BB', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Ningbo First Hospital of Zhejiang Province, Ningbo Ctiy, China.'}, {'ForeName': 'Bai-Xin', 'Initials': 'BX', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing Ctiy, Jiangsu Province, China.'}, {'ForeName': 'Wan-Zhang', 'Initials': 'WZ', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Ningbo First Hospital of Zhejiang Province, Ningbo Ctiy, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Urology, Ningbo First Hospital of Zhejiang Province, Ningbo Ctiy, China.'}, {'ForeName': 'Yun-Peng', 'Initials': 'YP', 'LastName': 'Shao', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing Ctiy, Jiangsu Province, China.'}, {'ForeName': 'Jun-Hai', 'Initials': 'JH', 'LastName': 'Qian', 'Affiliation': 'Department of Urology, Ningbo First Hospital of Zhejiang Province, Ningbo Ctiy, China. Electronic address: doctorqian2010@hotmail.com.'}]",Urology,['10.1016/j.urology.2022.01.013']
1073,35562205,Tolerability and Pharmacokinetics of Single Escalating and Repeated Doses of CN-105 in Healthy Participants.,"PURPOSE


CN-105 is an IV, apolipoprotein E-mimetic pentapeptide. Preclinical studies have reported that CN-105 effectively down-regulates neuroinflammatory responses in microglia and mitigates neuronal excitotoxicity following acute brain injury. The CN-105 Phase I and II trials that have been done in the United States have demonstrated that CN-105 was well tolerated in US participants. Thus, the main objective of the present Phase I study was to investigate the tolerability and pharmacokinetic (PK) profiles of CN-105 in healthy Chinese participants.
METHODS


This randomized, double-blind, placebo-controlled, dose-escalation study was performed in healthy participants using sequential 30-minute IV administration of single and multiple doses of CN-105 (four times daily for 13 doses). Forty volunteers were randomly assigned, in an 8:2 ratio, to one of four dosing groups, receiving either CN-105 (0.03, 0.1, 0.3, or 1 mg/kg), or placebo. Serial blood samples were collected for the measurement of plasma concentrations of CN-105. Tolerability was also assessed.
FINDINGS


After single-dose administration, the plasma CN-105 concentration rapidly reached the peak by the end of infusion. The mean elimination half-life of CN-105 ranged from 2.3 to 3.6 hours. During single- and multiple-dosing paradigms, exposure to CN-105 (AUC) exhibited linear dependency on dose. Steady state was reached by the fourth dose, with minimal accumulation. The PK properties of CN-105 with single and multiple dosing were comparable to those observed in US participants. CN-105 was generally well tolerated in Chinese participants. A total of 13 adverse events were reported in 30% of subjects (12/40) at the 0.03 mg/kg (6/8), 0.1 mg/kg (1/8), 0.3 mg/kg (2/8), 1 mg/kg (0/8) doses and with placebo (3/8). All adverse events were mild or moderate in severity and self-limited, with no dose relationship observed.
IMPLICATIONS


CN-105 was well tolerated in these healthy Chinese participants at doses of 0.1 to 1 mg/kg with single and multiple IV administrations. The PK characteristics of CN-105 were comparable among Chinese and Western subjects. A Phase II study in patients with intracranial hemorrhage is being planned in China.
CLINICALTRIALS


gov identifiers: NCT02670824 and NCT03168581; Chinese Clinical Trial Registration identifier: CTR20202397.",2022,"A total of 13 adverse events were reported in 30% of subjects (12/40) at the 0.03 mg/kg (6/8), 0.1 mg/kg (1/8), 0.3 mg/kg (2/8), 1 mg/kg (0/8) doses and with placebo (3/8).","['Healthy Participants', 'Chinese participants', 'patients with intracranial hemorrhage is being planned in China', 'healthy participants', 'healthy Chinese participants', 'Forty volunteers']","['placebo', 'CN-105']","['Steady state', 'Tolerability', 'mean elimination half-life of CN-105', 'plasma CN-105 concentration', 'Tolerability and Pharmacokinetics', 'tolerability and pharmacokinetic (PK) profiles of CN-105']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",40.0,0.208696,"A total of 13 adverse events were reported in 30% of subjects (12/40) at the 0.03 mg/kg (6/8), 0.1 mg/kg (1/8), 0.3 mg/kg (2/8), 1 mg/kg (0/8) doses and with placebo (3/8).","[{'ForeName': 'Shuya', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; China National Clinical Research Center for Neurological Diseases, Beijing, China; Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Runqi', 'Initials': 'R', 'LastName': 'Wangqin', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China; Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing), Beijing Institute of Lifeomics, Beijing, China.'}, {'ForeName': 'Haichen', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Laskowitz', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; China National Clinical Research Center for Neurological Diseases, Beijing, China. Electronic address: connie_6096@126.com.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; China National Clinical Research Center for Neurological Diseases, Beijing, China; Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]",Clinical therapeutics,['10.1016/j.clinthera.2022.03.006']
1074,35562821,"""I expected little, although I learned a lot"": perceived benefits of participating in HIV risk reduction sessions among women engaged in sex work in Uganda.","BACKGROUND


The global HIV burden remains a public health concern. Women engaged in sex work (WESW) are at higher risk of acquiring HIV compared to the general adult population. Uganda reports high rates of HIV prevalence among WESW. While WESW in Uganda have long been the subject of surveillance studies, they have not been targeted by theory-informed HIV prevention intervention approaches. In this study, we explored the perceived benefits of an evidence-based HIV risk reduction intervention that was implemented as part of a combination intervention tested in a clinical trial in Uganda.
METHODS


As part of a larger randomized clinical trial, we conducted semi-structured in-depth interviews with 20 WESW selected using a stratified purposive sampling. All interviews were conducted in Luganda, language spoken in the study area, and audio-recorded. They were transcribed verbatim and translated to English. Thematic analysis was used to analyze the data.
RESULTS


WESW's narratives focused on: (1) condom use; (2) alcohol/drug consumption; (3) PrEP use; (4) ""handling"" customers; and (5) ""massaging"" customers. WESW agreed that male condom was one of the important learning points for them and planned to continue using them while female condoms were received with mixed reactions. Many women appreciated receiving information about the risks of consuming alcohol and drugs, and discussed how they reduced/ eliminated their consumption. PrEP information was appreciated though identified by fewer WESW. Handling a client was discussed as a helpful strategy for safer sex through improved ability to convince customers to use condoms or avoiding sex. Massaging was also beneficial to avoid penetrative sex, but similar to female condom, massaging also yielded mixed perceptions.
CONCLUSION


WESW found the intervention beneficial and described ways in which it improved their ability to engage in safer sex and stay healthy. The fact that WESW identified other strategies beyond condom use as helpful underlines the importance of adopting a comprehensive approach to behavioral interventions targeting HIV prevention even when combined with other interventions. Additionally, WESW's narratives suggest that incorporating the tenets of social cognitive theory and harm reduction approaches in HIV prevention among this population can result in risk behavior change.",2022,Handling a client was discussed as a helpful strategy for safer sex through improved ability to convince customers to use condoms or avoiding sex.,[],['evidence-based HIV risk reduction intervention'],[],[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0544237,Handling a client was discussed as a helpful strategy for safer sex through improved ability to convince customers to use condoms or avoiding sex.,"[{'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA. Ozge.sensoybahar@wustl.edu.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Nabayinda', 'Affiliation': 'International Center for Child Health and Development Field Office, Masaka, Uganda.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Witte', 'Affiliation': 'Columbia University School of Social Work, New York City, NY, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kiyingi', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Larissa Jennings', 'Initials': 'LJ', 'LastName': 'Mayo-Wilson', 'Affiliation': 'School of Global Public Health, University of Carolina Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Prema', 'Initials': 'P', 'LastName': 'Filippone', 'Affiliation': 'Columbia University School of Social Work, New York City, NY, USA.'}, {'ForeName': 'Lyla Sunyoung', 'Initials': 'LS', 'LastName': 'Yang', 'Affiliation': 'Columbia University School of Social Work, New York City, NY, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Nakigudde', 'Affiliation': 'College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'School of Global Public Health, New York University, New York City, NY, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}]",BMC women's health,['10.1186/s12905-022-01759-1']
1075,35568376,"Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE): Rationale, study design, methods, and sample characteristics.","BACKGROUND


Chronic pain is associated with profound negative effects, and racial disparities are well-documented in chronic pain treatment. In addition, Black patients report poorer communication with providers and exhibit lower levels of patient activation (self-management self-efficacy) than White patients. Although the causes of healthcare disparities are complex and require intervention at multiple levels, empowering patients is one critical path to achieving health equity. The current study is a coaching intervention focused on increasing patient activation and building communication skills for Black patients with chronic pain.
METHODS


In this randomized controlled trial, 250 Black patients with chronic pain were randomized to either the coaching intervention or an attention control arm. Intervention patients attended 6 telephone-delivered individual coaching sessions over 12 weeks. Coaching focused on clarifying and prioritizing goals and on communication skills, such as agenda setting. The primary outcome is patient activation. Secondary outcomes include communication self-efficacy, pain intensity and interference, and psychological functioning.
DISCUSSION


Having the knowledge and confidence to participate in one's pain care, coupled with the skills needed to effectively communicate with providers, is essential to optimize chronic pain care. This is particularly important for Black patients who often experience lower quality pain care. Interventions such as COOPERATE hold promise for helping patients to acquire the requisite tools to take greater control of their chronic pain care.
TRIAL REGISTRATION


clinicaltrials.gov, # NCT03562793.",2022,"The current study is a coaching intervention focused on increasing patient activation and building communication skills for Black patients with chronic pain.
","['Black patients with chronic pain', '250 Black patients with chronic pain', 'Black patients who often experience lower quality pain care']","['telephone-delivered individual coaching sessions', 'coaching intervention or an attention control arm', 'coaching intervention']","['patient activation', 'communication self-efficacy, pain intensity and interference, and psychological functioning', 'patient activation (self-management self-efficacy', 'patient activation and building communication skills']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",250.0,0.162428,"The current study is a coaching intervention focused on increasing patient activation and building communication skills for Black patients with chronic pain.
","[{'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Matthias', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, United States of America; Regenstrief Institute, Indianapolis, IN, United States of America; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States of America. Electronic address: mmatthia@iu.edu.'}, {'ForeName': 'Jasma', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, United States of America.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Burgess', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Veterans Affairs Medical Center, Minneapolis, MN, United States of America; Department of Medicine, University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Daggy', 'Affiliation': 'Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Eliacin', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, United States of America; Regenstrief Institute, Indianapolis, IN, United States of America; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Flores', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, United States of America.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hirsh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University, Indianapolis, IN, United States of America.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Myers', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, United States of America; Regenstrief Institute, Indianapolis, IN, United States of America; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Tetla', 'Initials': 'T', 'LastName': 'Menen', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, United States of America.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Procento', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University, Indianapolis, IN, United States of America.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Rand', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University, Indianapolis, IN, United States of America.'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Salyers', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University, Indianapolis, IN, United States of America.'}, {'ForeName': 'Mackenzie L', 'Initials': 'ML', 'LastName': 'Shanahan', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University, Indianapolis, IN, United States of America.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, United States of America; Regenstrief Institute, Indianapolis, IN, United States of America; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106790']
1076,35569448,Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial.,"Importance


The efficacy and safety of prone positioning is unclear in nonintubated patients with acute hypoxemia and COVID-19.
Objective


To evaluate the efficacy and adverse events of prone positioning in nonintubated adult patients with acute hypoxemia and COVID-19.
Design, Setting, and Participants


Pragmatic, unblinded randomized clinical trial conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia, and the US. Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation. A total of 400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021.
Intervention


Patients were randomized to awake prone positioning (n = 205) or usual care without prone positioning (control; n = 195).
Main Outcomes and Measures


The primary outcome was endotracheal intubation within 30 days of randomization. The secondary outcomes included mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events.
Results


Among the 400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial. In the first 4 days after randomization, the median duration of prone positioning was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone positioning group were intubated vs 79 of 195 patients (40.5%) in the control group (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P = .20; absolute difference, -6.37% [95% CI, -15.83% to 3.10%]). Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P = .54; absolute difference, -1.15% [95% CI, -9.40% to 7.10%]) and had no significant effect on days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or on days free from the intensive care unit or hospital at 60 days. There were no serious adverse events in either group. In the awake prone positioning group, 21 patients (10%) experienced adverse events and the most frequently reported were musculoskeletal pain or discomfort from prone positioning (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). There were no reported adverse events in the control group.
Conclusions and Relevance


In patients with acute hypoxemic respiratory failure from COVID-19, prone positioning, compared with usual care without prone positioning, did not significantly reduce endotracheal intubation at 30 days. However, the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit.
Trial Registration


ClinicalTrials.gov Identifier: NCT04350723.",2022,"Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93","['Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation', '400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021', 'nonintubated adult patients with acute hypoxemia and COVID-19', '21 hospitals in Canada, Kuwait, Saudi Arabia, and the US', 'nonintubated patients with acute hypoxemia and COVID-19', '400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial', 'patients with acute hypoxemic respiratory failure', 'Patients With COVID-19 and Acute Respiratory Failure']","['awake prone positioning (n\u2009=\u2009205) or usual care without prone positioning (control; n\u2009=\u2009195', 'Awake Prone Positioning']","['median duration of prone positioning', 'mortality', 'musculoskeletal pain or discomfort from prone positioning', 'endotracheal intubation', 'adverse events', 'mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events', 'serious adverse events', 'Endotracheal Intubation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0445105', 'cui_str': 'Not intubated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}]","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517624', 'cui_str': '195'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",400.0,0.261069,"Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93","[{'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Alhazzani', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ken Kuljit S', 'Initials': 'KKS', 'LastName': 'Parhar', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services and University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Weatherald', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Al Duhailib', 'Affiliation': 'Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alshahrani', 'Affiliation': 'Department of Emergency and Critical Care, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Al-Fares', 'Affiliation': 'Department of Anesthesia, Critical Care Medicine, and Pain Medicine, Al Amiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Buabbas', 'Affiliation': 'Department of Anesthesia, Critical Care Medicine, and Pain Medicine, Jaber Al-Ahmad Al-Sabah Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Sujith V', 'Initials': 'SV', 'LastName': 'Cherian', 'Affiliation': 'Department of Internal Medicine, Divisions of Critical Care, Pulmonary, and Sleep Medicine, University of Texas Health-McGovern Medical School, Houston.'}, {'ForeName': 'Laveena', 'Initials': 'L', 'LastName': 'Munshi', 'Affiliation': 'Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Fan', 'Affiliation': 'Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Al-Hameed', 'Affiliation': 'Department of Intensive Care, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Chalabi', 'Affiliation': 'Intensive Care Department, Ministry of National Guard Health Affairs, Al Ahsa, Saudi Arabia.'}, {'ForeName': 'Amera A', 'Initials': 'AA', 'LastName': 'Rahmatullah', 'Affiliation': 'Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Duan', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jennifer L Y', 'Initials': 'JLY', 'LastName': 'Tsang', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lauzier', 'Affiliation': 'Department of Medicine, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Centofanti', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Culgin', 'Affiliation': ""Research Institute of St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.""}, {'ForeName': 'Katlynne', 'Initials': 'K', 'LastName': 'Nelson', 'Affiliation': ""Research Institute of St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.""}, {'ForeName': 'Sheryl Ann', 'Initials': 'SA', 'LastName': 'Abdukahil', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Fiest', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services and University of Calgary, Calgary, Canada.'}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Stelfox', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services and University of Calgary, Calgary, Canada.'}, {'ForeName': 'Haytham', 'Initials': 'H', 'LastName': 'Tlayjeh', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Maureen O', 'Initials': 'MO', 'LastName': 'Meade', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Perri', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Solverson', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services and University of Calgary, Calgary, Canada.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Niven', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services and University of Calgary, Calgary, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Division of Respirology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Belley-Cote', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Tamim', 'Affiliation': 'College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2022.7993']
1077,35569283,Phase 3 trial of sequential versus combination treatment in colorectal cancer: The C-cubed study.,"BACKGROUND


An optimal treatment strategy using oxaliplatin and bevacizumab for metastatic colorectal cancer has not been defined. We investigated whether the sequential treatment using fluoropyrimidines with bevacizumab followed by the addition of oxaliplatin at first progression was better than a combination treatment using fluoropyrimidines and oxaliplatin with bevacizumab.
METHODS


In the sequential treatment, the escalation from fluoropyrimidines plus bevacizumab to fluoropyrimidines plus oxaliplatin with bevacizumab was recommended in case of progressive disease. Time to failure of strategy was the primary end-point, whereas the secondary end-points were overall survival, progression-free survival, overall response rate and safety.
RESULTS


Three hundred patients with previously untreated metastatic colorectal cancer were randomised to receive either the sequential treatment (n = 151) or the combination treatment (n = 149). The sequential treatment was superior to the combination treatment about time to failure of strategy (15.2 months; 95% CI, 12.5-17.2 months vs. 7.8 months: 95% CI, 6.3-9.5 months; P < 0.001). However, the median overall survival was 27.5 (95% CI, 24.4 to 32.7) months in the sequential treatment and 27.0 (95% CI, 22.8 to 36.0) months in the combination treatment (hazard ratio, 0.92; 95% CI, 0.66 to 1.28; P = 0.61). The overall response rate was 33.1% in the sequential treatment arm and 51.7% in the combination treatment.
CONCLUSIONS


The findings support the extension of the sequential treatment starting from fluoropyrimidine plus bevacizumab to selected patients who do not need an objective response to the threatening disease.",2022,"The sequential treatment was superior to the combination treatment about time to failure of strategy (15.2 months; 95% CI, 12.5-17.2 months vs. 7.8 months: 95% CI, 6.3-9.5 months; P < 0.001).","['metastatic colorectal cancer', 'colorectal cancer', 'Three hundred patients with previously untreated metastatic colorectal cancer']","['oxaliplatin', 'oxaliplatin and bevacizumab', 'fluoropyrimidines with bevacizumab', 'fluoropyrimidine plus bevacizumab', 'oxaliplatin with bevacizumab', 'fluoropyrimidines and oxaliplatin with bevacizumab']","['Time to failure of strategy', 'overall survival, progression-free survival, overall response rate\xa0and safety', 'median overall survival', 'overall response rate']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",300.0,0.295045,"The sequential treatment was superior to the combination treatment about time to failure of strategy (15.2 months; 95% CI, 12.5-17.2 months vs. 7.8 months: 95% CI, 6.3-9.5 months; P < 0.001).","[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Inada', 'Affiliation': 'Department of Gastroenterological Surgery, Kochi Health Sciences Centre, Kochi, Kochi, Japan; Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School Hospital, Kurashiki, Okayama, Japan; Department of Gastroenterological Surgery, Okayama University Hospital, Okayama, Okayama, Japan. Electronic address: takeshin@med.kawasaki-m.ac.jp.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan; Cancer Biostatistics Laboratory, Clinical Research Institute, National Hospital Organisation Kyushu Cancer Centre, Fukuoka, Fukuoka, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ojima', 'Affiliation': 'Department of Gastroenterological Surgery, Gunma Prefectural Cancer Centre, Ota, Gunma, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Noura', 'Affiliation': 'Department of Surgery, Osaka Rosai Hospital, Sakai, Osaka, Japan; Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tanioka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School Hospital, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Munemoto', 'Affiliation': 'Department of Surgery, Fukui-ken Saiseikai Hospital, Fukui, Fukui, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Division of Clinical Oncology, Kochi Health Sciences Centre, Kochi, Kochi, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Centre, Saitama Medical University, Kawagoe, Saitama, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Shindo', 'Affiliation': 'Department of Gastroenterological Surgery, Nakadori General Hospital, Akita, Akita, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Mishima', 'Affiliation': 'Cancer Centre, Aichi Medical University, Nagakute, Aichi, Japan.'}, {'ForeName': 'Masasumi', 'Initials': 'M', 'LastName': 'Okajima', 'Affiliation': 'Department of Surgery, Hiroshima City Hospital, Hiroshima, Hiroshima, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School Hospital, Kurashiki, Okayama, Japan.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.04.009']
1078,35575171,A feasibility randomized controlled trial of a multi-process action control web-based intervention that targets physical activity in mothers.,"The onset of motherhood is associated with a decline in moderate- to vigorous-physical activity (MVPA) and this deficit can remain for years to come. This study explored the feasibility of a web-based intervention, informed by the multi-process action control (M-PAC) framework, to promote PA in mothers. Forty-one inactive mothers of children <16 were randomized to a 10-week web-intervention ( n  = 20) or wait-list control ( n  = 21). Primary outcomes of recruitment and retention were measured with frequency counts; usability and satisfaction were measured via self-report questionnaires and qualitative interviews; secondary outcomes of MVPA and M-PAC constructs were assessed via self-report. Recruitment was 41%, retention was 88%, and satisfaction and usability were high. Participants logged in 7.94 (SD = 3.87) times and spent 37.71 (SD = 20.21) minutes per week on the web-intervention. Suggestions for intervention improvement included additional content targeting mothers, reminders, and optimized navigation. Intervention participants trended toward improved MVPA and M-PAC constructs, particularly action control processes of habit, self-identity, and behavioral regulation. The high feasibility ratings of recruitment, retention, satisfaction, and usability demonstrated that the study can be extended to a full-scale RCT with minor additions to the intervention such as content targeting mothers, reminders, and optimized navigation.",2022,"Intervention participants trended toward improved MVPA and M-PAC constructs, particularly action control processes of habit, self-identity, and behavioral regulation.","['Forty-one inactive mothers of children <16', 'mothers']","['10-week web-intervention ( n \u2009=\u200920) or wait-list control', 'multi-process action control web-based intervention']","['recruitment and retention were measured with frequency counts; usability and satisfaction were measured via self-report questionnaires and qualitative interviews; secondary outcomes of MVPA and M-PAC constructs', 'MVPA and M-PAC constructs, particularly action control processes of habit, self-identity, and behavioral regulation']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376249', 'cui_str': 'Frequency'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",,0.0316058,"Intervention participants trended toward improved MVPA and M-PAC constructs, particularly action control processes of habit, self-identity, and behavioral regulation.","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hollman', 'Affiliation': 'Behavioural Medicine Lab, University of Victoria, Victoria, Canada.'}, {'ForeName': 'Wuyou', 'Initials': 'W', 'LastName': 'Sui', 'Affiliation': 'Behavioural Medicine Lab, University of Victoria, Victoria, Canada.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'Behavioural Medicine Lab, University of Victoria, Victoria, Canada.'}]",Women & health,['10.1080/03630242.2022.2072050']
1079,35044504,Macular pigment optical density responses to different levels of zeaxanthin in patients with high myopia.,"PURPOSE


Measurement of macular pigment optical density (MPOD) can be conducted to assist in the diagnosis of multiple fundus diseases.
METHODS


Fifty-four subjects with high myopia were prospectively recruited for a 3-month clinical trial. Detailed ophthalmologic examinations and MPOD measurements were performed. The subjects in each high myopia category group were randomly subdivided into 5 intervention groups, including a low-dose Lycium barbarum group (10 g Lycium barbarum, containing 10 mg of zeaxanthin and 1 mg of lutein), low-dose control group (1 mg of lutein), high-dose Lycium barbarum group (20 g of Lycium barbarum, containing 20 mg of zeaxanthin and 2 mg lutein), high-dose control group (2 mg of lutein), and a blank control group. Differences in the MPODs among the high myopia groups were calculated with Welch two-sample t tests. A linear mixed-effects model was constructed and Pearson's correlation analysis was performed to determine correlations between MPOD and other factors. The MPOD values at baseline and the 3-month follow-up were compared with the Mann-Whitney test.
RESULTS


The category 1 group had a significantly higher MPOD than the category 2 (P = 0.02) and category 3 groups (P < 0.001). The category 2 group had a significantly higher MPOD than the category 3 group (P < 0.001). The MPOD significantly decreased with increasing axial length (AL) and decreasing best-corrected visual acuity (BCVA) in the category 1-3 groups and with increasing age and increasing intraocular pressure (IOP) in the category 2-3 groups. The MPOD was significantly higher in the group who received high-dose zeaxanthin from Lycium barbarum than in the group who received high-dose lutein at 3 months (P = 0.0403), while no significant difference was identified between the low-dose zeaxanthin group and low-dose lutein group (P = 0.1117).
CONCLUSIONS


The MPOD was negatively correlated with the category of high myopia. Supplementation of zeaxanthin from Lycium barbarum is beneficial in preventing the loss of macular pigment of high myopia patients.
TRIAL REGISTRATION


Trial registration number and date of registration: ChiCTR2100046748.",2022,The category 2 group had a significantly higher MPOD than the category 3 group (P < 0.001).,"['Fifty-four subjects with high myopia', 'patients with high myopia', 'subjects in each high myopia category group']","['low-dose Lycium barbarum group (10\xa0g Lycium barbarum, containing 10\xa0mg of zeaxanthin and 1\xa0mg of lutein), low-dose control group (1\xa0mg of lutein), high-dose Lycium barbarum group (20\xa0g of Lycium barbarum, containing 20\xa0mg of zeaxanthin and 2\xa0mg lutein), high-dose control group (2\xa0mg of lutein', 'zeaxanthin from Lycium barbarum', 'zeaxanthin', 'macular pigment optical density (MPOD']","['axial length (AL) and decreasing best-corrected visual acuity (BCVA', 'intraocular pressure (IOP', 'MPOD', 'MPOD values']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0271183', 'cui_str': 'Severe myopia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1088997', 'cui_str': 'Goji Berry Plant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",54.0,0.0363997,The category 2 group had a significantly higher MPOD than the category 3 group (P < 0.001).,"[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Cao', 'Affiliation': 'Beijing Institute of Ophthalmology, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Ningli', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing, 100730, China. hansong1975@sina.com.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-021-05532-2']
1080,35567630,Effect of intra-nasal nitrilotriacetic acid trisodium salt in lowering elevated calcium cations and improving olfactory dysfunction in COVID-19 patients.,"PURPOSE


An association between COVID-19 and olfactory dysfunction has been noted in many patients worldwide. The olfactory adaptation process leads to an increase in intracellular calcium cation levels. Nitrilotriacetic acid trisodium salt has high selective chelation for calcium cations from olfactory mucus. The aim of this work is to test the effect of an intranasal nitrilotriacetic acid trisodium salt to lower the elevated calcium cations in COVID-19 patients with relevant symptoms of olfactory dysfunction.
METHODS


Fifty-eight COVID-19 adult patients with relevant symptoms of olfactory dysfunction were enrolled in a prospective randomized controlled trial. They received a nasal spray containing either 0.9% sodium chloride or 2% nitrilotriacetic acid trisodium salt. Olfactory function was assessed before and after treatment using the Sniffin' Sticks test. Quantitative analysis of calcium cation concentration in nasal secretions was performed using a carbon paste ion-selective electrode.
RESULTS


After the application of nitrilotriacetic acid trisodium salt compared to sodium chloride, a significant improvement from functional anosmia to healthy normosmia with significant decrease in calcium cation concentration was observed.
CONCLUSIONS


Further collaborative research is needed to fully investigate the effect of an intranasal nitrilotriacetic acid trisodium salt in the treatment of olfactory disorders.",2022,"After the application of nitrilotriacetic acid trisodium salt compared to sodium chloride, a significant improvement from functional anosmia to healthy normosmia with significant decrease in calcium cation concentration was observed.
","['Fifty-eight COVID-19 adult patients with relevant symptoms of olfactory dysfunction', 'COVID-19 patients', 'COVID-19 patients with relevant symptoms of olfactory dysfunction']","['sodium chloride', 'nasal spray containing either 0.9% sodium chloride or 2% nitrilotriacetic acid trisodium salt', 'intranasal nitrilotriacetic acid trisodium salt', 'intra-nasal nitrilotriacetic acid trisodium salt']","['calcium cation concentration', 'Olfactory function', 'olfactory dysfunction', 'intracellular calcium cation levels']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}, {'cui': 'C0028132', 'cui_str': 'Nitrilotriacetic Acid'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0596235', 'cui_str': 'Calcium ion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",58.0,0.0627257,"After the application of nitrilotriacetic acid trisodium salt compared to sodium chloride, a significant improvement from functional anosmia to healthy normosmia with significant decrease in calcium cation concentration was observed.
","[{'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Abdelazim', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Al-Azhar University, Damietta, 34518, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Abdelazim', 'Affiliation': 'Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Nasr City, Cairo, 11751, Egypt. ahmed.hussienabdelazim@hotmail.com.'}, {'ForeName': 'Wael F', 'Initials': 'WF', 'LastName': 'Ismaiel', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Al-Azhar University, Damietta, 34518, Egypt.'}, {'ForeName': 'Mahmoud E', 'Initials': 'ME', 'LastName': 'Alsobky', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Al-Azhar University, Damietta, 34518, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Al-Azhar University, Damietta, 34518, Egypt.'}, {'ForeName': 'Abdelgawad M', 'Initials': 'AM', 'LastName': 'Hadeya', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Al-Azhar University, Damietta, 34518, Egypt.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Ramzy', 'Affiliation': 'Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Nasr City, Cairo, 11751, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Shahin', 'Affiliation': 'Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Damanhour University, Beheira, Egypt.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-022-07424-5']
1081,35568312,Efficacy and safety of HD-tDCS and respiratory rehabilitation for critically ill patients with COVID-19 The HD-RECOVERY randomized clinical trial.,"BACKGROUND AND PURPOSE


Acute Respiratory Distress Syndrome (ADRS) due to coronavirus disease 2019 (COVID-19) has been associated with muscle fatigue, corticospinal pathways dysfunction, and mortality. High-Definition transcranial Direct Current Stimulation (HD-tDCS) may be used to attenuate clinical impairment in these patients. The HD-RECOVERY randomized clinical trial was conducted to evaluate the efficacy and safety of HD-tDCS with respiratory rehabilitation in patients with moderate to severe ARDS due to COVID-19.
METHODS


Fifty-six critically ill patients were randomized 1:1 to active (n = 28) or sham (n = 28) HD-tDCS (twice a day, 30-min, 3-mA) plus respiratory rehabilitation for up to 10 days or until intensive care unit discharge. The primary outcome was ventilator-free days during the first 28 days, defined as the number of days free from mechanical ventilation. Furthermore, secondary outcomes such as delirium, organ failure, hospital length of stay and adverse effects were investigated.
RESULTS


Active HD-tDCS induced more ventilator-free days compared to sham HD-tDCS. Patients in the active group vs in the sham group experienced lower organ dysfunction, delirium, and length of stay rates over time. In addition, positive clinical response was higher in the active vs sham group. There was no significant difference in the prespecified secondary outcomes at 5 days. Adverse events were similar between groups.
CONCLUSIONS


Among patients with COVID-19 and moderate to severe ARDS, use of active HD-tDCS compared with sham HD-tDCS plus respiratory rehabilitation resulted in a statistically significant increase in the number of ventilator-free days over 28 days. HD-tDCS combined with concurrent rehabilitation therapy is a safe, feasible, potentially add-on intervention, and further trials should examine HD-tDCS efficacy in a larger sample of patients with COVID-19 and severe hypoxemia.",2022,"Patients in the active group vs in the sham group experienced lower organ dysfunction, delirium, and length of stay rates over time.","['critically ill patients with COVID-19', 'Fifty-six critically ill patients', 'patients with moderate to severe ARDS due to COVID-19']","['HD-tDCS and respiratory rehabilitation', 'sham (n\u202f=\u202f28) HD-tDCS (twice a day, 30-min, 3-mA) plus respiratory rehabilitation', 'HD-tDCS combined with concurrent rehabilitation therapy', 'High-Definition transcranial Direct Current Stimulation (HD-tDCS', 'HD-tDCS']","['positive clinical response', 'number of ventilator-free days', 'Adverse events', 'ventilator-free days during the first 28 days, defined as the number of days free from mechanical ventilation', 'lower organ dysfunction, delirium, and length of stay rates', 'Efficacy and safety', 'efficacy and safety', 'delirium, organ failure, hospital length of stay and adverse effects']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",56.0,0.184311,"Patients in the active group vs in the sham group experienced lower organ dysfunction, delirium, and length of stay rates over time.","[{'ForeName': 'Suellen Marinho', 'Initials': 'SM', 'LastName': 'Andrade', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil. Electronic address: suellen.andrade@academico.ufpb.br.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cecília de Araújo Silvestre', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Eduardo Ériko', 'Initials': 'EÉ', 'LastName': 'Tenório de França', 'Affiliation': 'Health Secretary, Government of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Maria Heloísa', 'Initials': 'MH', 'LastName': 'Bezerra Sales Queiroz', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'de Jesus Santana', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Marcela Lais', 'Initials': 'ML', 'LastName': 'Lima Holmes Madruga', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Cristina Katya', 'Initials': 'CK', 'LastName': 'Torres Teixeira Mendes', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Araújo de Oliveira', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'João Felipe', 'Initials': 'JF', 'LastName': 'Bezerra', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Renata Gomes', 'Initials': 'RG', 'LastName': 'Barreto', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Silmara Maria', 'Initials': 'SM', 'LastName': 'Alves Fernandes da Silva', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Alves de Sousa', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Wendy Chrystyan', 'Initials': 'WC', 'LastName': 'Medeiros de Sousa', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Patrícia da Silva', 'Affiliation': 'Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Vanessa Meira', 'Initials': 'VM', 'LastName': 'Cintra Ribeiro', 'Affiliation': 'Health Secretary, Government of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Lucena', 'Affiliation': 'Health Secretary, Government of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Beltrammi', 'Affiliation': 'Health Secretary, Government of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Rodrigo Ramos', 'Initials': 'RR', 'LastName': 'Catharino', 'Affiliation': 'Thomson Mass Spectrometry Laboratory, Institute of Chemistry, State University of Campinas, UNICAMP, Campinas, SP, Brazil.'}, {'ForeName': 'Egas', 'Initials': 'E', 'LastName': 'Caparelli-Dáquer', 'Affiliation': 'Nervous System Electric Stimulation Lab, Rio de Janeiro State University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Hampstead', 'Affiliation': 'Research Program on Cognition and Neuromodulation Based Interventions, Department of Psychiatry, University of Michigan & Mental Health Service, VA Ann Arbor Healthcare System, Ann Arbor, Ann Arbor, United States.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York of CUNY, New York, United States.'}, {'ForeName': 'Antonio Lucio', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center, Houston, United States.'}, {'ForeName': 'Bernardino', 'Initials': 'B', 'LastName': 'Fernández-Calvo', 'Affiliation': 'Department of Psychology, University of Cordoba, Cordoba, Spain; Maimonides Biomedical Research Institute of Cordoba (IMIBIC), University of Cordoba, Cordoba, Spain.'}, {'ForeName': 'João Ricardo', 'Initials': 'JR', 'LastName': 'Sato', 'Affiliation': 'Center of Mathematics, Computing and Cognition. Federal University of ABC, Santo André, Brazil.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York of CUNY, New York, United States.'}]",Brain stimulation,['10.1016/j.brs.2022.05.006']
1082,35568270,An event-related potential investigation of distanced self-talk: Replication and comparison to detached reappraisal.,"Emotion regulation is critical for managing stress, but many regulatory strategies consume high levels of cognitive resources to implement, which are depleted under stress. This raises a conundrum: the tools we have to feel better may be ineffective when they are most needed. Recent event-related potential (ERP) research indicates that distanced self-talk (i.e., reflecting on one's experiences using non-first-person singular pronouns and one's name) reduces negative emotional reactivity without overtaxing cognitive resources. Here, we report the first direct replication of this work and extend it by examining how distanced self-talk compares to detached reappraisal, one of the most frequently studied regulatory techniques. Sixty-seven participants were randomly assigned to an emotion regulation picture task and instructed to reflect on the feelings they experienced in response to viewing negative emotional images using distanced self-talk or detached reappraisal while ERPs were measured. Directly replicating past findings, distanced self-talk led to a reduction in an affective arousal ERP, the late positive potential (LPP), without increasing stimulus preceding negativity (SPN), an ERP that reflects anticipatory and preparatory processing. These results further bolster support for distanced self-talk as a relatively effortless emotion regulation strategy. On the other hand, detached reappraisal was neither associated with the modulation of the LPP nor the SPN. Due to the failed replication of the reappraisal effect, a direct comparison between emotion regulation strategies was not conducted. Methodological limitations that may have contributed to the reappraisal failure and future directions for comparisons between emotion regulation strategies are discussed.",2022,"On the other hand, detached reappraisal was neither associated with the modulation of the LPP nor the SPN.",['Sixty-seven participants'],['emotion regulation picture task and instructed to reflect on the feelings they experienced in response to viewing negative emotional images using distanced self-talk or detached reappraisal while ERPs'],[],"[{'cui': 'C4517852', 'cui_str': '67'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015214', 'cui_str': 'Evoked potential'}]",[],67.0,0.0228438,"On the other hand, detached reappraisal was neither associated with the modulation of the LPP nor the SPN.","[{'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Webster', 'Affiliation': 'Department of Psychology, Michigan State University, USA. Electronic address: webst230@msu.edu.'}, {'ForeName': 'Martha K', 'Initials': 'MK', 'LastName': 'Berg', 'Affiliation': 'Department of Psychology, University of Michigan, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Kross', 'Affiliation': 'Department of Psychology, University of Michigan, USA; Ross School of Business, University of Michigan, USA.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Moser', 'Affiliation': 'Department of Psychology, Michigan State University, USA.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2022.05.003']
1083,35569079,Effect of Robot-Assisted Radical Cystectomy With Intracorporeal Urinary Diversion vs Open Radical Cystectomy on 90-Day Morbidity and Mortality Among Patients With Bladder Cancer: A Randomized Clinical Trial.,"Importance


Robot-assisted radical cystectomy is being performed with increasing frequency, but it is unclear whether total intracorporeal surgery improves recovery compared with open radical cystectomy for bladder cancer.
Objectives


To compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy.
Design, Setting, and Participants


Randomized clinical trial of patients with nonmetastatic bladder cancer recruited at 9 sites in the UK, from March 2017-March 2020. Follow-up was conducted at 90 days, 6 months, and 12 months, with final follow-up on September 23, 2021.
Interventions


Participants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169).
Main Outcomes and Measures


The primary outcome was the number of days alive and out of the hospital within 90 days of surgery. There were 20 secondary outcomes, including complications, quality of life, disability, stamina, activity levels, and survival. Analyses were adjusted for the type of diversion and center.
Results


Among 338 randomized participants, 317 underwent radical cystectomy (mean age, 69 years; 67 women [21%]; 107 [34%] received neoadjuvant chemotherapy; 282 [89%] underwent ileal conduit reconstruction); the primary outcome was analyzed in 305 (96%). The median number of days alive and out of the hospital within 90 days of surgery was 82 (IQR, 76-84) for patients undergoing robotic surgery vs 80 (IQR, 72-83) for open surgery (adjusted difference, 2.2 days [95% CI, 0.50-3.85]; P = .01). Thromboembolic complications (1.9% vs 8.3%; difference, -6.5% [95% CI, -11.4% to -1.4%]) and wound complications (5.6% vs 16.0%; difference, -11.7% [95% CI, -18.6% to -4.6%]) were less common with robotic surgery than open surgery. Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, -0.07 [95% CI, -0.11 to -0.03]; P = .003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 [95% CI, 0.15-0.73]; P = .003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 [95% CI, 0.09-0.68]; P = .01); the differences were not significant after 12 weeks. There were no statistically significant differences in cancer recurrence (29/161 [18%] vs 25/156 [16%] after robotic and open surgery, respectively) and overall mortality (23/161 [14.3%] vs 23/156 [14.7%]), respectively) at median follow-up of 18.4 months (IQR, 12.8-21.1).
Conclusions and Relevance


Among patients with nonmetastatic bladder cancer undergoing radical cystectomy, treatment with robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a statistically significant increase in days alive and out of the hospital over 90 days. However, the clinical importance of these findings remains uncertain.
Trial Registration


ISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.",2022,"Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, -0.07 [95% CI, -0.11 to -0.03]; P = .003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 [95% CI, 0.15-0.73]; P = .003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 [95% CI, 0.09-0.68]; P = .01); the differences were not significant after 12 weeks.","['patients with nonmetastatic bladder cancer recruited at 9 sites in the UK, from March 2017-March 2020', '338 randomized participants, 317 underwent radical cystectomy (mean age, 69 years; 67 women [21%]; 107 [34%] received', 'patients with nonmetastatic bladder cancer undergoing', 'Patients With Bladder Cancer']","['Robot-Assisted Radical Cystectomy', 'Intracorporeal Urinary Diversion vs Open Radical Cystectomy', 'neoadjuvant chemotherapy', 'radical cystectomy', 'ileal conduit reconstruction', 'robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy', 'robot-assisted radical cystectomy with intracorporeal reconstruction (n\u2009=\u2009169) or open radical cystectomy', 'Importance\n\n\nRobot-assisted radical cystectomy', 'robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy']","['complications, quality of life, disability, stamina, activity levels, and survival', 'recovery and morbidity', 'Thromboembolic complications', 'overall mortality', 'median number of days alive and out of the hospital within 90 days of surgery', 'greater disability', 'quality of life vs robotic surgery', 'wound complications', 'cancer recurrence', 'number of days alive and out of the hospital within 90 days of surgery', 'mean European Quality of Life 5-Dimension, 5-Level instrument scores', '90-Day Morbidity and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0042020', 'cui_str': 'Urinary diversion procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348002', 'cui_str': 'Ileal Conduit'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",338.0,0.548492,"Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, -0.07 [95% CI, -0.11 to -0.03]; P = .003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 [95% CI, 0.15-0.73]; P = .003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 [95% CI, 0.09-0.68]; P = .01); the differences were not significant after 12 weeks.","[{'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Pramit', 'Initials': 'P', 'LastName': 'Khetrapal', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, England.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ricciardi', 'Affiliation': 'Owlstone Medical, Cambridge, England.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Department of Statistical Science, University College London, London, England.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Surgical and Interventional Trials Unit (SITU), Division of Surgery and Interventional Science, University College London, London, England.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Al-Hammouri', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, England.'}, {'ForeName': 'Muhammad Shamim', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': ""Department of Urology, Guys and St Thomas' NHS Foundation Trust, London, England.""}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Thurairaja', 'Affiliation': ""Department of Urology, Guys and St Thomas' NHS Foundation Trust, London, England.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': ""Department of Urology, Guys and St Thomas' NHS Foundation Trust, London, England.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feber', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, England.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': 'Health Economics and Decision Science, NIHR Research Design Service Yorkshire and the Humber, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Nathan', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, England.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Briggs', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, England.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, England.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, Scotland.'}, {'ForeName': 'Jaimin', 'Initials': 'J', 'LastName': 'Bhatt', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, Scotland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Charlesworth', 'Affiliation': 'The Harold Hopkins Department of Urology, Royal Berkshire NHS Foundation Trust, Reading, England.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blick', 'Affiliation': 'The Harold Hopkins Department of Urology, Royal Berkshire NHS Foundation Trust, Reading, England.'}, {'ForeName': 'Marcus G', 'Initials': 'MG', 'LastName': 'Cumberbatch', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kotwal', 'Affiliation': 'Pyrah Department of Urology, St James University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, England.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Koupparis', 'Affiliation': 'Department of Urology, North Bristol NHS Trust, Bristol, England.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McGrath', 'Affiliation': 'Department of Urology, Royal Devon University Hospitals Foundation Trust and University of Exeter, Exeter, England.'}, {'ForeName': 'Aidan P', 'Initials': 'AP', 'LastName': 'Noon', 'Affiliation': 'Department of Urology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, North Bristol NHS Trust, Bristol, England.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Vasdev', 'Affiliation': 'Hertfordshire and Bedfordshire Urological Cancer Centre, Lister Hospital, University of Hertfordshire, Hatfield, England.'}, {'ForeName': 'Vishwanath', 'Initials': 'V', 'LastName': 'Hanchanale', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, England.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Hagan', 'Affiliation': 'Department of Statistical Science, University College London, London, England.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Department of Statistical Science, University College London, London, England.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Kelly', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2022.7393']
1084,35569036,Trial of a Preferential Phosphodiesterase 4B Inhibitor for Idiopathic Pulmonary Fibrosis.,"BACKGROUND


Phosphodiesterase 4 (PDE4) inhibition is associated with antiinflammatory and antifibrotic effects that may be beneficial in patients with idiopathic pulmonary fibrosis.
METHODS


In this phase 2, double-blind, placebo-controlled trial, we investigated the efficacy and safety of BI 1015550, an oral preferential inhibitor of the PDE4B subtype, in patients with idiopathic pulmonary fibrosis. Patients were randomly assigned in a 2:1 ratio to receive BI 1015550 at a dose of 18 mg twice daily or placebo. The primary end point was the change from baseline in the forced vital capacity (FVC) at 12 weeks, which we analyzed with a Bayesian approach separately according to background nonuse or use of an antifibrotic agent.
RESULTS


A total of 147 patients were randomly assigned to receive BI 1015550 or placebo. Among patients without background antifibrotic use, the median change in the FVC was 5.7 ml (95% credible interval, -39.1 to 50.5) in the BI 1015550 group and -81.7 ml (95% credible interval, -133.5 to -44.8) in the placebo group (median difference, 88.4 ml; 95% credible interval, 29.5 to 154.2; probability that BI 1015550 was superior to placebo, 0.998). Among patients with background antifibrotic use, the median change in the FVC was 2.7 ml (95% credible interval, -32.8 to 38.2) in the BI 1015550 group and -59.2 ml (95% credible interval, -111.8 to -17.9) in the placebo group (median difference, 62.4 ml; 95% credible interval, 6.3 to 125.5; probability that BI 1015550 was superior to placebo, 0.986). A mixed model with repeated measures analysis provided results that were consistent with those of the Bayesian analysis. The most frequent adverse event was diarrhea. A total of 13 patients discontinued BI 1015550 treatment owing to adverse events. The percentages of patients with serious adverse events or severe adverse events were similar in the two trial groups.
CONCLUSIONS


In this placebo-controlled trial, treatment with BI 1015550, either alone or with background use of an antifibrotic agent, prevented a decrease in lung function in patients with idiopathic pulmonary fibrosis. (Funded by Boehringer Ingelheim; 1305-0013 ClinicalTrials.gov number, NCT04419506.).",2022,"The percentages of patients with serious adverse events or severe adverse events were similar in the two trial groups.
","['Idiopathic Pulmonary Fibrosis', 'patients with idiopathic pulmonary fibrosis', '13 patients discontinued BI 1015550 treatment owing to adverse events', 'A total of 147 patients']","['placebo', 'BI 1015550 at a dose of 18 mg twice daily or placebo', 'Preferential Phosphodiesterase 4B Inhibitor', 'BI 1015550 or placebo']","['background nonuse or use of an antifibrotic agent', 'forced vital capacity (FVC', 'median change in the FVC', 'lung function', 'serious adverse events or severe adverse events']","[{'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0613494', 'cui_str': 'Phosphodiesterase 4B'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",147.0,0.636636,"The percentages of patients with serious adverse events or severe adverse events were similar in the two trial groups.
","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Richeldi', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hesslinger', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Stowasser', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Valenzuela', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': 'Marlies S', 'Initials': 'MS', 'LastName': 'Wijsenbeek', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': 'Donald F', 'Initials': 'DF', 'LastName': 'Zoz', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Voss', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'From Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); Nippon Medical School, Tokyo (A.A.); Hôpital Louis Pradel, Centre National de Référence des Maladies Pulmonaires Rares, Hospices Civils de Lyon, Unité Mixte de Recherche 754 Institut National de la Recherche Agronomique and Université Claude Bernard Lyon 1, ERN-LUNG (European Reference Network on Rare Respiratory Diseases), RespiFil, OrphaLung, Lyon, France (V.C.); Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim International, Biberach (C.H.), and TA Inflammation Medicine (S.S.), Boehringer Ingelheim Pharma (F.V.), Ingelheim am Rhein - both in Germany; the Interstitial Lung Disease Unit, Department of Pulmonology, Hospital Universitario de la Princesa, University Autonoma de Madrid, Madrid (C.V.); the Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, the Netherlands (M.S.W.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (D.F.Z.); Keck School of Medicine, University of Southern California, Los Angeles (T.M.M.); and the National Heart and Lung Institute, Imperial College London, London (T.M.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2201737']
1085,35575012,Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events.,"OBJECTIVE


Although patient-reported symptoms and side effects are increasingly measured in cancer clinical trials, an appropriate assessment frequency has not yet been established. To determine whether differences in assessment frequency affect the apparent incidence and severity of patient-reported symptoms using two well-established patient-reported outcome measures used within the same clinical trial.
METHODS


We examined patient-reported outcome results from AURA3 (NCT02151981), a randomized open-label study comparing Tagrisso (osimertinib) with platinum-based chemotherapy in patients with previously treated estimated glomerular filtration rate/T790M mutation-positive metastatic non-small cell lung cancer. The outcome of interest was the proportion of patients in each arm that reported worsening of nausea, vomiting, fatigue, diarrhea, constipation, and appetite loss from baseline measured using the patient-reported outcome-common terminology criteria for adverse event (weekly) or European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (every 6 weeks).
RESULTS


Similar trends were observed for all six symptoms investigated. Using nausea in the chemotherapy arm as an example, 76% of patients reported any worsening from baseline based on weekly patient-reported outcome-common terminology criteria for adverse event assessments. When using an every 6-week assessment of Quality of Life Questionnaire Core 30 nausea and restricting analysis to an every 6-week assessment for patient-reported outcome-common terminology criteria for adverse event nausea, the proportion of chemotherapy arm patients reporting any worsening of nausea was 40% for both measures. Across the six patient-reported symptomatic adverse events, we observed differential proportions when comparing frequent versus sparse assessment.
CONCLUSION


This analysis demonstrates that more frequent assessment of patient-reported symptomatic adverse events will lead to improved detection, and therefore a more complete understanding of the tolerability of experimental anti-cancer therapies.",2022,"The outcome of interest was the proportion of patients in each arm that reported worsening of nausea, vomiting, fatigue, diarrhea, constipation, and appetite loss from baseline measured using the patient-reported outcome-common terminology criteria for adverse event (weekly) or European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (every 6 weeks).
",['patients with previously treated estimated glomerular filtration rate/T790M mutation-positive metastatic non-small cell lung cancer'],['Tagrisso (osimertinib) with platinum-based chemotherapy'],"['worsening of nausea, vomiting, fatigue, diarrhea, constipation, and appetite loss', 'symptomatic adverse events', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C4058817', 'cui_str': 'Tagrisso'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.311188,"The outcome of interest was the proportion of patients in each arm that reported worsening of nausea, vomiting, fatigue, diarrhea, constipation, and appetite loss from baseline measured using the patient-reported outcome-common terminology criteria for adverse event (weekly) or European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (every 6 weeks).
","[{'ForeName': 'Bellinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Bhatnagar', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Erica G', 'Initials': 'EG', 'LastName': 'Horodniceanu', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Ting-Yu', 'Initials': 'TY', 'LastName': 'Chen', 'Affiliation': 'ORISE, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA.'}]","Clinical trials (London, England)",['10.1177/17407745221093935']
1086,35578194,Group treatment for complex dissociative disorders: a randomized clinical trial.,"BACKGROUND


Patients with complex dissociative disorders (CDD) report high levels of childhood- abuse experiences, clinical comorbidity, functional impairment, and treatment utilization. Although a few naturalistic studies indicate that these patients can benefit from psychotherapy, no randomized controlled trials have been reported with this patient-group. The current study evaluates a structured protocolled group treatment delivered in a naturalistic clinical setting to patients with CDD, as an add-on to individual treatment.
METHODS


Fifty nine patients with CDD were randomized to 20 sessions of stabilizing group-treatment, conjoint with individual therapy, or individual therapy alone, in a delayed-treatment design. The treatment was based on the manual Coping with Trauma-Related Dissociation. The primary outcome was Global Assessment of Functioning (GAF), while secondary outcomes were PTSD and dissociative symptoms, general psychopathology, and interpersonal difficulties.
RESULTS


Mixed effect models showed no condition x time interaction during the delayed treatment period, indicating no immediate differences between conditions in the primary outcome. Similar results were observed for secondary outcomes. Within-group effects were non-significant in both conditions from baseline to end of treatment, but significant improvements in psychosocial function, PTSD symptoms, and general psychopathology were observed over a 6-months follow-up period.
CONCLUSION


In the first randomized controlled trial for the treatment of complex dissociative disorders, stabilizing group treatment did not produce immediate superior outcomes. Treatment was shown to be associated with improvements in psychological functioning.
TRIAL REGISTRATION


Clinical Trials ( NCT02450617 ).",2022,"In the first randomized controlled trial for the treatment of complex dissociative disorders, stabilizing group treatment did not produce immediate superior outcomes.","['Fifty', 'nine patients with CDD', 'Patients with complex dissociative disorders (CDD']","['stabilizing group-treatment, conjoint with individual therapy, or individual therapy alone']","['PTSD and dissociative symptoms, general psychopathology, and interpersonal difficulties', 'condition x time interaction', 'psychological functioning', 'psychosocial function, PTSD symptoms, and general psychopathology', 'Global Assessment of Functioning (GAF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012746', 'cui_str': 'Dissociative disorder'}]","[{'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",59.0,0.232563,"In the first randomized controlled trial for the treatment of complex dissociative disorders, stabilizing group treatment did not produce immediate superior outcomes.","[{'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Bækkelund', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Hospital, Vikersund, Norway. harald.bakkelund@nkvts.no.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Ulvenes', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Hospital, Vikersund, Norway.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Boon-Langelaan', 'Affiliation': 'Private practice, Maarssen, The Netherlands.'}, {'ForeName': 'Espen Ajo', 'Initials': 'EA', 'LastName': 'Arnevik', 'Affiliation': 'Section for clinical addiction research, Oslo University Hospital, Oslo, Norway.'}]",BMC psychiatry,['10.1186/s12888-022-03970-8']
1087,35578174,A novel intervention to reduce noninfectious and infectious complications associated with indwelling urethral catheters in hospitalized older patients: a quasi-experimental study.,"BACKGROUND


Indwelling urethral catheters are widely used in clinical settings. Catheter-associated urinary tract infection has been recognized as a common adverse event in older patients. However, noninfectious complications are almost 5 times as common as infectious complications, and insufficient attention has been given to noninfectious complications. Given this importance, a novel intervention related to removing unnecessary catheters in a timely manner to promote, after removal, the recovery of self-voiding function is herein developed to reduce infectious and noninfectious complications associated with indwelling urethral catheters in hospitalized older patients.
METHODS


A quasi-experimental study design was adopted. Patients aged 65 and older who had a urinary catheter placed within 24 h of hospital admission were included. All patients were allocated into either an intervention group, in which the novel intervention developed in the study was implemented, or a control group, who received care as usual. The outcomes of this study were to evaluate whether the novel intervention reduced the incidence of the following: catheter-associated urinary tract infections, catheter-associated noninfectious complications, decline in activities of daily living, and new nursing home admissions.
RESULTS


Of 106 hospitalized older patients who consented to participate, 92 completed follow-up until discharge, including 49 in the control group and 43 in the intervention group. The patients in the intervention group were significantly older than those in the control group [83.72 ± 9.18 vs. 80.26 ± 7.66, p = 0.038], and no differences were found between the groups in other demographics or present health conditions. Multivariable logistic regression analysis showed that the control group was more likely to develop noninfectious complications [adjusted odds ratio: 3.01, 95% confidence interval: 1.32-6.81] and a decline in ADLs [adjusted odds ratio: 11.20, 95% confidence interval: 3.68-34.00].
CONCLUSIONS


A novel intervention can be effective as a means of reducing noninfectious complications associated with indwelling urethral catheters in hospitalized older patients. This approach will help to standardize urethral catheter care, and it highlights the fact that health care professionals can play a crucial role in preventing harm from urethral catheters.",2022,"CONCLUSIONS


A novel intervention can be effective as a means of reducing noninfectious complications associated with indwelling urethral catheters in hospitalized older patients.","['Patients aged 65 and older who had a urinary catheter placed within 24\xa0h of hospital admission were included', 'hospitalized older patients', 'older patients', '106 hospitalized older patients who consented to participate, 92 completed follow-up until discharge, including 49 in the control group and 43 in the intervention group']",['indwelling urethral catheters'],"['incidence of the following: catheter-associated urinary tract infections, catheter-associated noninfectious complications, decline in activities of daily living, and new nursing home admissions', 'noninfectious complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0555850', 'cui_str': 'Indwelling urethral catheter'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",106.0,0.0702301,"CONCLUSIONS


A novel intervention can be effective as a means of reducing noninfectious complications associated with indwelling urethral catheters in hospitalized older patients.","[{'ForeName': 'Fang-Wen', 'Initials': 'FW', 'LastName': 'Hu', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138, Sheng-Li Road, Tainan City, 70403, Taiwan.'}, {'ForeName': 'Chun-Yin', 'Initials': 'CY', 'LastName': 'Yeh', 'Affiliation': 'Department of Computer Science and Information Engineering, National Cheng Kung University, No. 1, University Road, Tainan City, 70101, Taiwan.'}, {'ForeName': 'Chi-Chang', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Geriatrics and Gerontology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138, Sheng-Li Road, Tainan City, 70403, Taiwan.'}, {'ForeName': 'Hsiu-Chi', 'Initials': 'HC', 'LastName': 'Cheng', 'Affiliation': 'Department of Internal Medicine, and Institute of Clinical Medicine and Molecular Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138, Sheng-Li Road, Tainan City, 70403, Taiwan.'}, {'ForeName': 'Cheng-Han', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Geriatrics and Gerontology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No. 138, Sheng-Li Road, Tainan City, 70403, Taiwan.'}, {'ForeName': 'Chia-Ming', 'Initials': 'CM', 'LastName': 'Chang', 'Affiliation': 'Division of Geriatrics and Gerontology, Department of Internal Medicine, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, No. 138, Sheng-Li Road, Tainan City, 70403, Taiwan. 10108040@gs.ncku.edu.tw.'}]",BMC geriatrics,['10.1186/s12877-022-03113-4']
1088,35567836,Seeking an optimal dose of preoperative corticosteroids in chronic rhinosinusitis with nasal polyposis: A randomized controlled trial.,"BACKGROUND


Preoperative corticosteroids have been shown to improve surgical visibility and intraoperative blood loss for chronic rhinosinusitis with nasal polyposis (CRSwNP) patients undergoing endoscopic sinus surgery (ESS). However, there is no consensus on the optimal dosing regimen.
METHODS


A randomized, controlled trial was conducted to compare low, medium, and high dose corticosteroids prior to ESS. Patients with CRSwNP refractory to medical management were randomized to low (N = 8), medium (N = 10), or high (N = 5) dosing regimens of corticosteroids prior to ESS. Baseline disease severity was measured with the 22-item Sino-nasal Outcome Test and Lund-Mackay scores. Modified Lund-Kennedy endoscopic scores (MLKES) were measured at baseline and after corticosteroid treatment. Intraoperative parameters were measured including Boezaart surgical visibility score, intraoperative blood loss, and operative time.
RESULTS


Medium dose corticosteroids demonstrated a superior surgical visibility score to low dose and comparable results to high dose, but these results were not significant (p = 0.33). No significant difference was observed between groups for total blood loss (p = 0.15), operative time (p = 0.87), or change in MLKES (p = 0.27).
CONCLUSIONS


Current recommendations include the use of preoperative corticosteroids in patients with CRSwNP undergoing ESS, but there is no consensus on dose or duration. We did not find a statistically significant difference in surgical field visibility, intraoperative blood loss, or operative time between different dosing regimens. Further studies are needed to evaluate the efficacy of a low-dose preoperative regimen with the goal of reducing cumulative patient exposure to systemic corticosteroids.",2022,"We did not find a statistically significant difference in surgical field visibility, intraoperative blood loss, or operative time between different dosing regimens.","['patients with CRSwNP undergoing ESS', 'chronic rhinosinusitis with nasal polyposis', 'Patients with CRSwNP refractory to medical management', 'chronic rhinosinusitis with nasal polyposis (CRSwNP) patients undergoing endoscopic sinus surgery (ESS']","['preoperative corticosteroids', 'corticosteroids prior to ESS']","['surgical visibility and intraoperative blood loss', 'Modified Lund-Kennedy endoscopic scores (MLKES', 'operative time', 'surgical field visibility, intraoperative blood loss, or operative time', '22-item Sino-nasal Outcome Test and Lund-Mackay scores', 'Baseline disease severity', 'superior surgical visibility score', 'total blood loss', 'Boezaart surgical visibility score, intraoperative blood loss, and operative time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}]",,0.14745,"We did not find a statistically significant difference in surgical field visibility, intraoperative blood loss, or operative time between different dosing regimens.","[{'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Kominsky', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: evan.s.kominsky@gmail.com.'}, {'ForeName': 'Katherine Y', 'Initials': 'KY', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Ninan', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Arrighi-Allisan', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Filimonov', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kidwai', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Northwell/Long Island Jewish Medical Center, New Hyde Park, NY, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Morton', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Alok T', 'Initials': 'AT', 'LastName': 'Saini', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Kentucky, Louisville, KY, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Spock', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Del Signore', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Govindaraj', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Alfred Marc', 'Initials': 'AM', 'LastName': 'Iloreta', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2022.103476']
1089,35567829,"Effect of activity-based training versus strengthening exercises on upper extremity functions in Parkinson's patients; A randomized controlled, single blind, superiority trial.","BACKGROUND


Idiopathic Parkinson's disease is a neurodegenerative disease which is appeared by symptoms such as resting tremor, bradykinesia, rigidity, and postural instability. Such symptoms as tremor, bradykinesia, and rigidity significantly affect patients' upper extremity function. Rehabilitation programs should be implemented to improve the upper extremity functions of patients.
OBJECTIVE


Activity-based training would improve dexterity and functional activities to a larger extent than strengthening exercises. This study aimed at evaluating the effect of activity-based training and strengthening exercises on upper extremity functions in Parkinson's disease and to compare the two methods.
METHOD


40 Parkinson's patients with mean of 64.45 ± 9.13 age were randomized and divided into two groups as activity-based training and strengthening exercise group. Patients were evaluated at the beginning and after 6 weeks of treatment with Unified Parkinson's Disease Rating Scale, Parkinson's Disease Questionnaire-39, Duruöz Hand Index, Jebsen Taylor Hand Function Test, Nine-Hole Peg Test, Jamar dynamometer, Jamar pinch meter, Semmes Weinstein Monofilament Test and two-point discrimination.
RESULT


In both groups, upper extremity functions, handgrip strengths and quality of life of patients improved significantly. Tactile sense improved only in the activity-based training group.
CONCLUSION


Activity-based training is not superior to strengthening exercise programs at improving upper extremity functions and dexterity of Parkinson's patients.",2022,"CONCLUSION


Activity-based training is not superior to strengthening exercise programs at improving upper extremity functions and dexterity of Parkinson's patients.","[""40 Parkinson's patients with mean of 64.45\xa0±\xa09.13 age"", ""Parkinson's disease"", ""Parkinson's patients""]","['activity-based training versus strengthening exercises', 'Activity-based training', 'activity-based training and strengthening exercise group', 'activity-based training and strengthening exercises']","['Tactile sense', ""Unified Parkinson's Disease Rating Scale, Parkinson's Disease Questionnaire-39, Duruöz Hand Index, Jebsen Taylor Hand Function Test, Nine-Hole Peg Test, Jamar dynamometer, Jamar pinch meter, Semmes Weinstein Monofilament Test and two-point discrimination"", 'upper extremity functions, handgrip strengths and quality of life', 'dexterity and functional activities']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0702221', 'cui_str': 'Touch sensation, function'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",40.0,0.0126236,"CONCLUSION


Activity-based training is not superior to strengthening exercise programs at improving upper extremity functions and dexterity of Parkinson's patients.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zare', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Trakya University Faculty of Medicine, Edirne, Turkey. Electronic address: mzare6065@gmail.com.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Özdemir', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Trakya University Faculty of Medicine, Edirne, Turkey. Electronic address: handeozdemirmd@gmail.com.'}, {'ForeName': 'Merve Yalçın', 'Initials': 'MY', 'LastName': 'Tavşan', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Trakya University Faculty of Medicine, Edirne, Turkey. Electronic address: Merveyalcin35@hotmail.com.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Tuna', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Trakya University Faculty of Medicine, Edirne, Turkey. Electronic address: drftuna@hotmail.com.'}, {'ForeName': 'Necdet', 'Initials': 'N', 'LastName': 'Süt', 'Affiliation': 'Department of Biostatistics, Trakya University Faculty of Medicine, Edirne, Turkey. Electronic address: necdetsut@yahoo.com.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Güler', 'Affiliation': 'Department of Neurology, Trakya University Faculty of Medicine, Edirne, Turkey. Electronic address: drsibelguler@yahoo.com.'}, {'ForeName': 'Derya Demirbağ', 'Initials': 'DD', 'LastName': 'Kabayel', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Trakya University Faculty of Medicine, Edirne, Turkey. Electronic address: deryaftr@gmail.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2022.107261']
1090,35568194,Prognosis of elderly non-valvular atrial fibrillation patients stratified by B-type natriuretic peptide: ELDERCARE-AF subanalysis.,"BACKGROUND


B-type natriuretic peptide (BNP) is a risk factor for stroke and cardiac death in patients with atrial fibrillation. We hypothesized the prognostic outcomes of very elderly non-valvular atrial fibrillation patients ineligible for standard anticoagulation treatment would vary according to BNP stratification.
METHODS


In this subanalysis of the ELDERCARE-AF trial, patients were stratified by BNP levels at enrollment, and clinical outcomes compared among BNP subgroups. Hazard ratios were adjusted for age, atrial fibrillation type, body mass index, creatine clearance, congestive heart failure, and D-dimer. BNP levels were measured using chemiluminescence enzyme immunoassays.
RESULTS


In total, 984 patients (average age: 86.6 years) not considered eligible for oral anticoagulant therapy at approved doses for stroke prevention were included. The BNP levels at enrollment were <200 (low), 200 to <400 (moderate), and ≥400 (high) pg/mL in 428, 300, and 256 patients, respectively. The number (%) of patients with stroke or systemic embolism (SSE) was 7 (1.2%), 24 (5.9%), and 28 (8.6%) in the low, moderate, and high BNP subgroups, respectively (adjusted hazard ratio 3.82, P = .0025 for low vs moderate BNP and 4.76, P = .0007 for low vs high BNP). There was no significant difference in major bleeding incidence between the BNP subgroups. Edoxaban 15 mg was associated with a consistent reduction in SSE vs placebo in all BNP subgroups.
CONCLUSIONS


Stratification by BNP level was associated with the incidence of SSE for very elderly non-valvular atrial fibrillation patients ineligible for standard anticoagulation treatment, and the effect of edoxaban 15 mg was consistent across BNP levels.",2022,There was no significant difference in major bleeding incidence between the BNP subgroups.,"['984 patients (average age: 86.6 years) not considered eligible for oral anticoagulant therapy at approved doses for stroke prevention were included', 'patients with atrial fibrillation', 'elderly non-valvular atrial fibrillation patients stratified by B-type natriuretic peptide', 'very elderly non-valvular atrial fibrillation (NVAF) patients ineligible for standard anticoagulation treatment']","['edoxaban', 'Edoxaban', 'SSE versus placebo', 'B-type natriuretic peptide (BNP']","['major bleeding incidence', 'stroke or systemic embolism (SSE', 'BNP levels', 'atrial fibrillation type, body mass index, creatine clearance, congestive heart failure, and D-dimer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]","[{'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}]",984.0,0.0696645,There was no significant difference in major bleeding incidence between the BNP subgroups.,"[{'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Okazaki', 'Affiliation': 'Department of Cardiology, National Center for Global Health and Medicine, Tokyo, Japan. Electronic address: ookazaki@me.com.'}, {'ForeName': 'Yorihiko', 'Initials': 'Y', 'LastName': 'Higashino', 'Affiliation': 'Department of Cardiology, Medical Corporation Aishinkai, Higashi Takarazuka Satoh Hospital, Hyogo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yokoya', 'Affiliation': 'Department of Cardiology, National Hospital Organization Toyohashi Medical Center, Aichi, Japan.'}, {'ForeName': 'Yoshimori', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Tanizawa', 'Affiliation': 'Clinical Development Department III, Development Function, Research and Development Division, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Clinical Development Department III, Development Function, Research and Development Division, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Data Governance & Data Engineering Group, Data Intelligence Department, Digital Transformation Management Division, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Akao', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}]",American heart journal,['10.1016/j.ahj.2022.05.009']
1091,35569753,Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease.,"Background App-based strategies are a promising solution to deliver nutrition and exercise interventions during social distancing. With limited RCT data in individuals with chronic disease, further information is required both to determine impact, and to guide delivery. The Heal-Me app is an evidence-based, theoretically informed nutrition and exercise solution that can be tailored for use across a range of individuals with chronic disease. As compared to controls receiving educational material, the aim of this study is to assess the acceptability, effectiveness, and cost of Heal-Me app programming delivered alongside two levels of dietitian and exercise-specialist support. Methods Heal-Me PiONEer is a 12-week, 3-arm RCT with randomization to one of three study groups (n=72 per group, 216 total). Group 1 (control: educational material), Group 2 (Heal-Me app + virtual group dietitian/exercise-specialist sessions), Group 3 (Heal-Me app + virtual group and 1-to-1 dietitian/exercise-specialist sessions). Inclusion criteria: adults with cancer, chronic lung disease or status post-transplantation from liver or lung transplant; previous completion of an exercise rehabilitation program; access to an internet-connected device. Study outcomes measured at study weeks 0 and 12 include: Primary - Lower Extremity Functional Scale; Secondary - virtual physical function tests, loneliness, resilience, anxiety, well-being and health-related quality of life; Exploratory outcomes - protein intake, behavioral beliefs around exercise and nutrition, adherence, adverse events, acceptability, and cost-utility. Conclusions The Heal-Me PiONEer RCT holds promise to provide a comprehensive understanding of the delivery and impact of app-based nutrition and exercise programming in a diverse group of participants with chronic disease.",2022,"The Heal-Me app is an evidence-based, theoretically informed nutrition and exercise solution that can be tailored for use across a range of individuals with chronic disease.","['individuals with chronic disease', 'Inclusion criteria: adults with cancer, chronic lung disease or status post-transplantation from liver or lung transplant; previous completion of an', 'participants with chronic disease']","['Heal-me PiONEer (personalized online nutrition and exercise', 'RCT', 'exercise rehabilitation program', 'Group 1 (control: educational material), Group 2 (Heal-Me app + virtual group dietitian/exercise-specialist sessions), Group 3 (Heal-Me app + virtual group and 1-to-1 dietitian/exercise-specialist sessions']","['Primary - Lower Extremity Functional Scale; Secondary - virtual physical function tests, loneliness, resilience, anxiety, well-being and health-related quality of life; Exploratory outcomes - protein intake, behavioral beliefs around exercise and nutrition, adherence, adverse events, acceptability, and cost-utility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0250109,"The Heal-Me app is an evidence-based, theoretically informed nutrition and exercise solution that can be tailored for use across a range of individuals with chronic disease.","[{'ForeName': 'Puneeta', 'Initials': 'P', 'LastName': 'Tandon', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada. Electronic address: ptandon@ualberta.ca.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Purdy', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Kathleen P', 'Initials': 'KP', 'LastName': 'Ismond', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Christofer', 'Initials': 'C', 'LastName': 'Cruz', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Etruw', 'Affiliation': 'Department of Medicine, Division of Pulmonary Medicine, University of Alberta, Edmonton, AB, Canada; Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Suderman', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Hyde', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stickland', 'Affiliation': 'Department of Medicine, Division of Pulmonary Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Spence', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Dale C', 'Initials': 'DC', 'LastName': 'Lien', 'Affiliation': 'Department of Medicine, Division of Pulmonary Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Bhanji', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Prado', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Antonio Miguel', 'Initials': 'AM', 'LastName': 'Cruz', 'Affiliation': 'Department of Occupational Therapy, Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Anil A', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, University of Alberta and Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Maryna', 'Initials': 'M', 'LastName': 'Yaskina', 'Affiliation': ""Women's and Children's Health Research Institute, Statistics, University of Alberta, Edmonton, AB, Canada.""}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Round', 'Affiliation': 'Institute of Health Economics, Edmonton, AB, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Harback', 'Affiliation': 'Institute of Health Economics, Edmonton, AB, Canada.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Padwal', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNeely', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, AB, Canada; Department of Oncology, Cancer Care Alberta, Edmonton, AB, Canada. Electronic address: mmcneely@ualberta.ca.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106791']
1092,35570689,Letter: ORBITA-2 trial design and rationale: what causes angina after PCI?,,2022,,[],[],[],[],[],[],,0.218514,,"[{'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Milasinovic', 'Affiliation': 'Department of Cardiology, University Clinical Center of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Stankovic', 'Affiliation': 'Department of Cardiology, University Clinical Center of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico Universitario San Carlos, IDISSC, Madrid, Spain.'}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-22-00222']
1093,35570601,An Alternative Abdominal Closure Technique After Pediatric Liver Transplant: Bogota Bag Technique.,"OBJECTIVES


In conditions such as large-for-size syndrome, postreperfusion hepatic edema, and intestinal edema, primary closure of the abdominal wall can cause respiratory complications and thrombosis of vascular structures. Here, we compared results of primary abdominal closure versus a temporary patch closure technique (the Bogota bag technique) in pediatric liver transplant recipients.
MATERIALS AND METHODS


We performed primary abdominal closure in 295 recipients. In 39 pediatric liver transplant recipients, the Bogota bag technique was used as the abdominal closure technique because of suspected intraoperative tense abdominal closure. In patients who had the Bogota bag technique, we sutured the sterilized saline bag to the skin at the edge of the defect by shaping the defect so as not to cause abdominal hypertension. Primary abdominal closure was achieved in patients after control laparotomies at 48-hour intervals.
RESULTS


The mean age of the primary abdominal closure group was 8.38 years, whereas the mean age of the Bogota bag group was 2 years. The average weight of patients in the primary abdominal closure group was 26.38 kg, and the average weight of patients in the Bogota bag group was 7.93 kg. Biliary atresia was the most common indication in both groups. Mean length of hospital stay was 21 days in the primary abdominal closure group and 24 days in Bogota bag group. Six patients in the Bogota bag group died from sepsis or bleeding in the early postoperative period. In the Bogota bag group, wound closure was achieved within 2 weeks in 25 patients and within 3 weeks in 8 patients.
CONCLUSIONS


Temporary patch closure techniques can be used safely in low-weight and young children, children with large-for-size grafts, and those who display increased intra-abdominal pressure.",2022,"In the Bogota bag group, wound closure was achieved within 2 weeks in 25 patients and within 3 weeks in 8 patients.
","['39 pediatric liver transplant recipients', 'We performed primary abdominal closure in 295 recipients', 'pediatric liver transplant recipients']","['primary abdominal closure versus a temporary patch closure technique (the Bogota bag technique', 'Alternative Abdominal Closure Technique']","['Biliary atresia', 'sepsis or bleeding', 'average weight', 'Mean length of hospital stay', 'wound closure']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0441615', 'cui_str': 'Patching - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C2936335', 'cui_str': 'Abdominal Closure Techniques'}]","[{'cui': 'C0005411', 'cui_str': 'Congenital biliary atresia'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]",295.0,0.0402908,"In the Bogota bag group, wound closure was achieved within 2 weeks in 25 patients and within 3 weeks in 8 patients.
","[{'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Karakaya', 'Affiliation': 'From the Baskent University, Department of General Surgery, Division of Transplantation, Ankara, Turkey.'}, {'ForeName': 'Aydıncan', 'Initials': 'A', 'LastName': 'Akdur', 'Affiliation': ''}, {'ForeName': 'Ebru Hatice', 'Initials': 'EH', 'LastName': 'Ayvazoğlu Soy', 'Affiliation': ''}, {'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Şafak', 'Affiliation': ''}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Moray', 'Affiliation': ''}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Haberal', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.PediatricSymp2022.O18']
1094,35578276,Effectiveness of a digital intervention versus alcohol information for online help-seekers in Sweden: a randomised controlled trial.,"BACKGROUND


The ubiquity of Internet connectivity, and widespread unmet needs, requires investigations of digital interventions for people seeking help with their drinking. The objective of this study was to test the effectiveness of a digital alcohol intervention compared to existing online resources for help seekers.
METHODS


This parallel randomised controlled trial included 2129 risky drinkers with access to a mobile phone and aged 18 years or older. Randomised sub-studies investigated consent procedures and control group design. Simple computerised randomisation was used. Participants were aware of allocation after randomisation; research personnel were not. The digital intervention was designed around weekly monitoring of alcohol consumption followed by feedback and tools for behaviour change. Primary outcomes were total weekly consumption (TWC) and frequency of heavy episodic drinking (HED), measured 2 and 4 months post-randomisation.
RESULTS


Between 25/04/2019 and 26/11/2020, 2129 participants were randomised (intervention: 1063, control: 1066). Negative binomial regression was used to contrast groups, with both Bayesian and maximum likelihood inference. The posterior median incidence rate ratio (IRR) of TWC was 0.89 (95% CI = 0.81;0.99, 98.2% probability of effect, P-value = 0.033) at 2 months among 1557 participants and 0.77 (95% CI = 0.69;0.86, > 99.9% probability of effect, P-value < 0.001) at 4 months among 1429 participants. For HED, the IRR was 0.83 (95% CI = 0.75;0.93, > 99.9% probability of effect, P-value = 0.0009) at 2 months among 1548 participants and 0.71 (95% CI = 0.63;0.79, probability of effect > 99.9%, P-value < 0.0001) at 4 months among 1424 participants. Analyses with imputed data were not markedly different.
CONCLUSIONS


A digital alcohol intervention produced self-reported behaviour change among online help seekers in the general population. The internal and external validity of this trial is strong, subject to carefully considered study limitations arguably inherent to trials of this nature. Limitations include higher than anticipated attrition to follow-up and lack of blinding.
TRIAL REGISTRATION


The trial was prospectively registered ( ISRCTN48317451 ).",2022,This parallel randomised controlled trial included 2129 risky drinkers with access to a mobile phone and aged 18 years or older.,"['2129 participants were randomised', 'Sweden', '2129 risky drinkers with access to a mobile phone and aged 18 years or older']","['digital intervention versus alcohol information', 'digital alcohol intervention']","['posterior median incidence rate ratio (IRR) of TWC', 'total weekly consumption (TWC) and frequency of heavy episodic drinking (HED), measured 2 and 4 months post-randomisation']","[{'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",2129.0,0.25084,This parallel randomised controlled trial included 2129 risky drinkers with access to a mobile phone and aged 18 years or older.,"[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Society and Health, Linköping University, 581 83, Linköping, Sweden. marcus.bendtsen@liu.se.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Åsberg', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Society and Health, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'McCambridge', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}]",BMC medicine,['10.1186/s12916-022-02374-5']
1095,35580635,Effect of long-duration oxygen vs room air during labor on umbilical cord venous partial pressure of oxygen: a randomized controlled trial.,"BACKGROUND


There are limited data to guide the duration and dose of oxygen supplementation for pregnant women undergoing labor.
OBJECTIVE


To assess the effect of maternal long-duration high-concentration oxygen administration during labor on umbilical cord venous partial pressure of oxygen.
STUDY DESIGN


This randomized clinical trial was conducted between January and October of 2021 in the obstetrics wards of 3 tertiary teaching hospitals in Beijing, China. Women undergoing the latent phase of labor with no existing medical conditions or obstetrical complications who were admitted for delivery were eligible. The women who met inclusion criteria with category I fetal heart rate tracings in labor were randomized in a 1:1 ratio to oxygen or room air. The oxygen group received 10 L of oxygen per minute by simple, tight-fitting face mask until delivery. The room-air group received room air only, without a face mask. The primary outcome was the umbilical cord venous partial pressure of oxygen.
RESULTS


A total of 661 women were screened, and 521 were excluded; 140 participants with category I fetal heart rate tracings were enrolled and randomized to oxygen (N=70) or room air (N=70). A total of 135 women with valid paired umbilical cord venous and arterial gas values were included in the umbilical cord venous partial pressure of oxygen and arterial pH analyses. All 140 women were included in the fetal heart rate tracings analysis. Baseline characteristics were similar between the oxygen and room-air groups. The duration of oxygen exposure was approximately 322±147 minutes. There were no differences between the oxygen and room-air groups in the umbilical cord venous partial pressure of oxygen (mean difference, 1.1 mm Hg; 95% confidence interval, -1.0 to 3.2; P=.318) or the proportion of participants with category II fetal heart rate tracings (81.4% vs 78.6%; relative risk, 1.04; 95% confidence interval, 0.88-1.22; P=.672). However, the umbilical cord arterial pH was significantly lower in the oxygen group than in the room-air group (median, 7.23; interquartile range, 7.20-7.27 vs median 7.27; interquartile range, 7.20-7.30; P=.005).
CONCLUSION


Maternal long-duration high-concentration oxygen administration during labor did not affect either the umbilical cord venous partial pressure of oxygen or fetal heart rate pattern distribution but resulted in a deterioration of the umbilical cord arterial pH at birth.",2022,"There were no differences between the oxygen and room air groups in the umbilical cord venous partial pressure of oxygen (mean difference 1.1 mmHg, 95% confidence interval -1.0 to 3.2; P = 0.318), or the proportion of participants with category II fetal heart rate tracings (81.4% versus 78.6%, relative risk 1.04, 95% confidence interval 0.88 to 1.22; P = 0.672).","['All 140 women were included in the fetal heart rate tracings analysis', 'pregnant women undergoing labor', 'umbilical cord venous partial pressure of oxygen', '661 women were screened, 521 were excluded; 140 participants with category I fetal heart rate tracings were enrolled and randomized to oxygen (N = 70) or room air (N = 70', 'Women undergoing the latent phase of labor with no existing medical conditions or obstetrics complications who were admitted for delivery were eligible', 'January 2021 and October 2021 in the obstetrics wards of three tertiary teaching hospitals in Beijing, China', 'women who met inclusion criteria with category I fetal heart rate tracings in labor', '135 women with validate paired umbilical cord venous and arterial gases were included in the umbilical cord venous partial pressure of oxygen and arterial pH analyses']","['maternal long-duration high-concentration oxygen administration during labor', 'room air only without a facemask', 'oxygen supplementation', 'long-duration oxygen vs room air during labor', '10 L of oxygen per minute by tight-fitting simple facemask until delivery']","['duration of oxygen exposure', 'umbilical cord venous partial pressure of oxygen', 'umbilical cord arterial pH']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0428170', 'cui_str': 'Measurement of venous partial pressure of oxygen'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4523997', 'cui_str': 'Category I fetal heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0178292', 'cui_str': 'Complication of pregnancy, childbirth and/or the puerperium'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0428170', 'cui_str': 'Measurement of venous partial pressure of oxygen'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}]",135.0,0.689442,"There were no differences between the oxygen and room air groups in the umbilical cord venous partial pressure of oxygen (mean difference 1.1 mmHg, 95% confidence interval -1.0 to 3.2; P = 0.318), or the proportion of participants with category II fetal heart rate tracings (81.4% versus 78.6%, relative risk 1.04, 95% confidence interval 0.88 to 1.22; P = 0.672).","[{'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Chuai', 'Affiliation': 'Chinese PLA General Hospital, Medical School of Chinese PLA, Beijing, China; Department of Obstetrics and Gynaecology, Sixth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Seventh Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Lanmei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chuai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sixth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiuyan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Obstetrics and Gynaecology, Seventh Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Kefei', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Department of Obstetrics and Gynecology, PLA Strategic Support Force Characteristic Medical Center, Beijing, China.'}, {'ForeName': 'Jinfang', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sixth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sixth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Chinese PLA General Hospital, Medical School of Chinese PLA, Beijing, China; Department of Obstetrics and Gynaecology, Sixth Medical Center, Chinese PLA General Hospital, Beijing, China. Electronic address: 3313400243@qq.com.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Chinese PLA General Hospital, Medical School of Chinese PLA, Beijing, China; Department of Obstetrics and Gynaecology, Seventh Medical Center, Chinese PLA General Hospital, Beijing, China. Electronic address: yqyao_ghpla@126.com.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2022.05.028']
1096,35580634,Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial.,"BACKGROUND


The efficacy of intradetrusor onabotulinumtoxinA injections for the management of idiopathic overactive bladder has been well-established. The injections are typically performed in the office setting using local analgesia, most commonly a 20 to 30-minute intravesical instillation of lidocaine. There are limited data evaluating alternative bladder analgesics.
OBJECTIVE


To compare pain scores with preprocedure oral phenazopyridine vs intravesical lidocaine in women undergoing intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder.
STUDY DESIGN


Nonpregnant adult females with idiopathic overactive bladder, scheduled for office injection of 100 units of intradetrusor onabotulinumtoxinA were randomized to either 200 mg of oral phenazopyridine taken 1 to 2 hours preprocedure or a 20-minute preprocedure intravesical instillation of 50 mL of 2% lidocaine. We excluded participants with neurogenic bladders, and those who had received intradetrusor onabotulinumtoxinA injections in the previous 12 months. The primary outcome was pain measured by a 100-mm visual analog scale. Demographic characteristics and overall satisfaction with the procedure were also recorded. Providers answered questions about cystoscopic visualization, ease of procedure, and perception of participant comfort. Prespecified noninferiority margin was set to equal the anticipated minimum clinically important difference of 14 mm. A planned sample of 100 participants, 50 in each treatment arm, provided 80% power to detect noninferiority at a significance level of.05. We performed a modified intention-to-treat analysis and compared variables with the t test or the Fisher exact test.
RESULTS


A total of 111 participants were enrolled, and complete data were obtained for 100 participants; 47 participants were randomized to phenazopyridine and 53 to lidocaine. Baseline characteristics did not differ between groups. There were 19.6% and 20.8% of participants in the phenazopyridine and lidocaine groups, respectively, who previously underwent intradetrusor onabotulinumtoxinA injections. The mean postprocedure pain was 2.7 mm lower in the phenazopyridine group than in the lidocaine group (95% confidence interval, -11.3 to 10.7), demonstrating noninferiority. More than 90% of participants in both groups stated that the pain was tolerable. Slightly more participants reported being ""very satisfied"" in the lidocaine group, although this was not statistically significant (50.0% vs 40.4%; P=.34). Providers reported clear visualization in 89.4% of participants in the phenazopyridine group and in 100% of participants in the lidocaine group (P=.02). Provider perception of participant comfort and overall ease of procedure were not different between groups. Length of time in the exam room was significantly shorter in the phenazopyridine than in the lidocaine group (44.4 vs 57.5 minutes; P=.0003).
CONCLUSION


In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder, oral phenazopyridine was noninferior to intravesical lidocaine for procedural pain control. Phenazopyridine is well-tolerated by participants, allows for the procedure to be performed with similar ease, and is associated with shorter appointment times.",2022,The mean post-procedure pain was 2.7mm lower in the phenazopyridine group vs the lidocaine group (95%CI: -11.3 to.,"['Bladder', 'Non-pregnant adult females with idiopathic overactive bladder, scheduled for office injection of 100 units intradetrusor onabotulinumtoxinA', 'women undergoing intradetrusor onabotulinumtoxinA for idiopathic overactive bladder (OAB', '47 participants', '111 participants were enrolled; complete data was obtained for 100 participants', 'participants with neurogenic bladder, and those who had received intradetrusor onabotulinumtoxinA injections in the previous 12 months']","['Oral Phenazopyridine vs Intravesical Lidocaine', 'Phenazopyridine', 'phenazopyridine', 'oral phenazopyridine taken 1-2 hours preprocedure versus a 20-minute preprocedure intravesical instillation of 50mL 2% lidocaine', 'OnabotulinumtoxinA Analgesia', 'lidocaine', 'phenazopyridine versus intravesical lidocaine', 'intradetrusor onabotulinumtoxinA injections']","['clear visualization', 'mean post-procedure pain', 'Demographic characteristics and overall satisfaction', 'pain measured by a 100mm visual analog scale (VAS', 'pain scores', 'Provider perception of participant comfort and overall ease of procedure', 'Length of time in the exam room']","[{'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031379', 'cui_str': 'Phenazopyridine'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]",47.0,0.245239,The mean post-procedure pain was 2.7mm lower in the phenazopyridine group vs the lidocaine group (95%CI: -11.3 to.,"[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Stewart', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Warren Alpert Medical School of Brown University and Women & Infants Hospital of Rhode Island, Providence, RI; Departments of Obstetrics and Gynecology and Urology, NYU Grossman School of Medicine/NYU Langone Health, New York, NY. Electronic address: Lauren.Stewart@NYULangone.org.'}, {'ForeName': 'Moiuri', 'Initials': 'M', 'LastName': 'Siddique', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Warren Alpert Medical School of Brown University and Women & Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Jacobs', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': 'Division of Research, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University and Women & Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Warren Alpert Medical School of Brown University and Women & Infants Hospital of Rhode Island, Providence, RI.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2022.05.025']
1097,35567859,"Association between hypertension and cutaneous melanoma, and the effect of aspirin: extended follow-up of a large randomised controlled trial.","BACKGROUND


The association between hypertension and melanoma is unclear, and previous analyses of data from the ASPirin in Reducing Events in the Elderly (ASPREE) study demonstrated a reduced number of invasive melanoma events amongst aspirin-exposed hypertensive individuals.
METHODS


Data from the ASPREE study which included (1) the intervention period with a median follow-up of 4.7 years, and (2) the observational period with an additional 2 years follow-up, were combined for this analysis. Logistic regression analyses examined the association between baseline hypertension and treatment status and past melanoma history. Survival analyses examined the association between hypertension and melanoma risk, and the effect of aspirin across hypertension groups. Cox proportional hazards models were used to compare incidence across groups.
RESULTS


19,114 participants (median age of 74 years) were randomised to daily 100 mg aspirin or placebo. At baseline, hypertension and past melanoma history were recorded in 14,195 and 685 individuals, respectively. After adjustment for confounders, hypertension was significantly associated with past melanoma history (OR=1.34, 95%CI: 1.11-1.62). In a prospective analysis, baseline hypertension was not associated with melanoma risk. However, aspirin was associated with a reduced risk of incident melanoma amongst individuals with uncontrolled hypertension (blood pressure ≥140/90 mmHg; HR=0.63, 95%CI 0.44-0.89), but not in those with controlled hypertension (HR=1.04, 95%CI 0.74-1.46).
CONCLUSION


Our results support a reduced melanoma incidence amongst individuals with uncontrolled hypertension exposed to aspirin. Additional studies are required to confirm these findings.",2022,"After adjustment for confounders, hypertension was significantly associated with past melanoma history (OR=1.34, 95%CI: 1.11-1.62).","['Data from the ASPREE study which included (1) the intervention period with a median follow-up of 4.7 years, and (2) the observational period with an additional 2 years follow-up', 'individuals with uncontrolled hypertension', '19,114 participants (median age of 74 years', 'exposed hypertensive individuals']","['aspirin or placebo', 'aspirin', 'ASPirin']",['hypertension and past melanoma history'],"[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0019664', 'cui_str': 'History'}]",19114.0,0.387012,"After adjustment for confounders, hypertension was significantly associated with past melanoma history (OR=1.34, 95%CI: 1.11-1.62).","[{'ForeName': 'Mabel K', 'Initials': 'MK', 'LastName': 'Yan', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC 3004, Australia; Victorian Melanoma Service, Alfred Health, 55 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: mabelkyan@gmail.com.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Nikki R', 'Initials': 'NR', 'LastName': 'Adler', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McLean', 'Affiliation': 'Department of Anatomical Pathology, Alfred Health, 55 Commercial Road, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Rodríguez', 'Affiliation': 'Gastrointestinal and Other Cancers Research Group, Division of Cancer Prevention, National Cancer Institute, NIH, Bethesda, MD, USA; Walter Reed National Military Medical Center (WRNMM) Uniformed Services University (USU) Department of Surgery, Bethesda, MD, USA.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, University of Melbourne,1 G Royal Parade, Parkville, Victoria 3052, Australia.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Massachusetts General Hospital, Massachusetts, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Medical Oncology, Alfred Health, 55 Commercial Road, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Mar', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC 3004, Australia; Victorian Melanoma Service, Alfred Health, 55 Commercial Road, Melbourne, VIC 3004, Australia.'}]",Cancer epidemiology,['10.1016/j.canep.2022.102173']
1098,35570289,Family connections vs treatment at usual optimized in the treatment of relatives of people with suicidal behavior disorder: study protocol of a randomized control trial.,"BACKGROUND


Relatives of people diagnosed with suicidal behavior disorder (SBD) feel guilty, afraid, hopeless, depression and anxiety. It is necessary to help the relatives of people with SBD to reduce their discomfort and burden. Family Connections (FC) is a program that has been shown to be effective in reducing burden, depression, and anxiety, and increasing dominance and validating behaviors in relatives of people with borderline personality disorder. However, there are no RCTs that demonstrate the efficacy of the FC program in patients with SBD. Our research team adapted FC for relatives of people with SBD for delivery in the Spanish population (FC-SBD). The FC-SBD program contains 12 two-hour sessions held once a week. The first aim is to verify the efficacy of the FC-SBD intervention for relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample. The second objective is to analyze the feasibility and acceptance of FC-SBD in relatives. The third aim is to analyze whether the changes produced in the psychological variables in the relatives after the intervention are related to changes in the psychological variables of the patients. This paper presents the study protocol.
METHODS


The study design consists of a two-arm randomized controlled trial with two conditions: FC-SBD or Treatment as usual optimized (TAU-O). Participants will be relatives of patients who meet DSM-5 criteria for SBD. The caregivers` primary outcome measures will be the BAS. Secondary outcomes will be DASS-21, FES, DERS, QoL. The patient's primary outcome measures will be the frequency of critical incidents with the family member with SBD. Secondary measures will be the INQ, PHQ-9, OASIS. Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing the data.
DISCUSSION


This study will provide results that confirm the efficacy of the FC-SBD in relatives of people with SBD. These results will also confirm its good acceptance by family members and help us to find out whether it is a good program to improve the prevention of suicidal behaviors in the family environment.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT05157607 . Registered 15 December 2021.",2022,The first aim is to verify the efficacy of the FC-SBD intervention for relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample.,"['Participants will be relatives of patients who meet DSM-5 criteria for SBD', 'relatives', 'Relatives of people diagnosed with suicidal behavior disorder (SBD', 'relatives of people with borderline personality disorder', 'relatives of people with SBD', 'patients with SBD', 'relatives of people with suicidal behavior disorder', 'relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample']","['FC-SBD intervention', 'FC-SBD or Treatment as usual optimized (TAU-O', 'FC-SBD']","['BAS', 'DASS-21, FES, DERS, QoL', 'frequency of critical incidents with the family member with SBD', 'INQ, PHQ-9, OASIS']","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1320736', 'cui_str': 'Critical incident'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}]",,0.0882847,The first aim is to verify the efficacy of the FC-SBD intervention for relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample.,"[{'ForeName': 'José H', 'Initials': 'JH', 'LastName': 'Marco', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamiento Psicológico, Universidad de Valencia, Facultad de Psicología, España. Avda. Blasco Ibañez, 21, Valencia, España. jose.h.marco@uv.es.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fonseca', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamiento Psicológico, Universidad de Valencia, Facultad de Psicología, España. Avda. Blasco Ibañez, 21, Valencia, España.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Fernandez-Felipe', 'Affiliation': 'Universitat Jaume I de Castelló, España. Facultad de Ciencias de la Salud, Avda Sos Baynat, S/N, Castellón, España.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Ciber Fisiopatologia Obesidad y Nutrición (CB06/03), Instituto Salud Carlos III, Madrid, España.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Baños', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamiento Psicológico, Universidad de Valencia, Facultad de Psicología, España. Avda. Blasco Ibañez, 21, Valencia, España.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Perez', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamiento Psicológico, Universidad de Valencia, Facultad de Psicología, España. Avda. Blasco Ibañez, 21, Valencia, España.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Garcia-Alandete', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamiento Psicológico, Universidad de Valencia, Facultad de Psicología, España. Avda. Blasco Ibañez, 21, Valencia, España.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Guillen', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamiento Psicológico, Universidad de Valencia, Facultad de Psicología, España. Avda. Blasco Ibañez, 21, Valencia, España.'}]",BMC psychiatry,['10.1186/s12888-022-03965-5']
1099,35570690,Reply: ORBITA-2 trial design and rationale: what causes angina after PCI?,,2022,,[],[],[],[],[],[],,0.189589,,"[{'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Al-Lamee', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-22-00264']
1100,35574927,"Bilateral Cerebellar Intermittent Theta Burst Stimulation Combined With Swallowing Speech Therapy for Dysphagia After Stroke: A Randomized, Double-Blind, Sham-Controlled, Clinical Trial.","BACKGROUND


Previous studies have found that high-frequency repetitive transcranial magnetic stimulation (rTMS) of the cerebellar hemisphere could improve swallowing function, but whether intermittent theta burst stimulation (iTBS), which has similar excitatory effect and higher efficiency, can also improve swallowing function for dysphagia after stroke remains unclear.
OBJECTIVE


This trial aimed to explore the efficacy and safety of bilateral cerebellar transcranial magnetic stimulation with iTBS for dysphagia after stroke.
METHODS


Seventy patients with dysphagia after stroke were divided into 2 treatment groups: true bilateral cerebellar iTBS and sham bilateral cerebellar iTBS. The true iTBS group underwent ten 100% resting motor threshold (RMT) iTBS sessions for 2 weeks. In the sham iTBS group, the parameters were the same except that the figure-eight coil was perpendicular to the skull. Both groups received traditional swallowing rehabilitation treatment 5 times a week for 2 weeks. Swallowing function was assessed with the Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS), Penetration/Aspiration Scale (PAS), Standardized Swallowing Assessment (SSA), and Functional Oral Intake Scale (FOIS) at baseline, 2 weeks after the intervention, and at 4 weeks of follow-up.
RESULTS


There were significant time and group interaction effects in both multi-factorial adjusted and unadjusted FEDSS, PAS, SSA, and FOIS score ( P  < .001). In the pairwise comparison of the swallowing parameters among the 2 groups, the FEDSS, PAS, SSA, and FOIS scores at 2 weeks and 4 weeks showed a significantly higher improvement in the iTBS simulation group than sham group ( P  < .05). In both the true iTBS and sham iTBS stimulation groups, all FEDSS, PAS, SSA, and FOIS scores were significantly improved over time ( P  < .001).
CONCLUSIONS


The present study suggested that as a more efficient TMS stimulation mode, iTBS could efficiently improve swallowing function by stimulating the bilateral cerebellar hemisphere. In addition, 100% resting motor threshold bilateral cerebellar iTBS is a relatively safe treatment.
CLINICAL TRIAL REGISTRATION


Effect analysis of repeated transcranial magnetic stimulation of cerebellar on dysphagia after stroke. www.chictr.org.cn. Identifier: ChiCTR2100042092.",2022,"In the pairwise comparison of the swallowing parameters among the 2 groups, the FEDSS, PAS, SSA, and FOIS scores at 2 weeks and 4 weeks showed a significantly higher improvement in the iTBS simulation group than sham group ( P  < .05).",['Seventy patients with dysphagia after stroke'],"['Swallowing Speech Therapy', 'repetitive transcranial magnetic stimulation (rTMS', 'true bilateral cerebellar iTBS and sham bilateral cerebellar iTBS', 'Bilateral Cerebellar Intermittent Theta Burst Stimulation', 'bilateral cerebellar transcranial magnetic stimulation with iTBS', 'traditional swallowing rehabilitation']","['FEDSS, PAS, SSA, and FOIS scores', 'unadjusted FEDSS, PAS, SSA, and FOIS score', 'Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS), Penetration/Aspiration Scale (PAS), Standardized Swallowing Assessment (SSA), and Functional Oral Intake Scale (FOIS', 'swallowing function', 'Swallowing function', 'Dysphagia']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0009460', 'cui_str': 'Communication disorder'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",70.0,0.133599,"In the pairwise comparison of the swallowing parameters among the 2 groups, the FEDSS, PAS, SSA, and FOIS scores at 2 weeks and 4 weeks showed a significantly higher improvement in the iTBS simulation group than sham group ( P  < .05).","[{'ForeName': 'Jinzhu', 'Initials': 'J', 'LastName': 'Rao', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, P.R. China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, Yue Bei People's Hospital, Shaoguan, P.R. China.""}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Rehabilitation Medicine, Yue Bei People's Hospital, Shaoguan, P.R. China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation Medicine, Yue Bei People's Hospital, Shaoguan, P.R. China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Department of Rehabilitation Medicine, Yue Bei People's Hospital, Shaoguan, P.R. China.""}, {'ForeName': 'Huiyu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Rehabilitation Medicine, Yue Bei People's Hospital, Shaoguan, P.R. China.""}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The Seventh Affiliated Hospital Sun Yat-sen University, Shenzhen, P.R. China.'}, {'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, P.R. China.'}]",Neurorehabilitation and neural repair,['10.1177/15459683221092995']
1101,35576879,Evaluation of a Clinical Decision Support System for the most evidence-based approach to managing perioperative anticoagulation.,"STUDY OBJECTIVE


We explored the feasibility of a Clinical Decision Support System (CDSS) to guide evidence-based perioperative anticoagulation.
DESIGN


Prospective randomised clinical management simulation multicentre study.
SETTING


Five University and 11 general hospitals in Germany.
PARTICIPANTS


We enrolled physicians (anaesthesiologist (n = 73), trauma surgeons (n = 2), unknown (n = 1)) with different professional experience.
INTERVENTIONS


A CDSS based on a multiple-choice test was developed and validated at the University Hospital of Frankfurt (phase-I). The CDSS comprised European guidelines for the management of anticoagulation in cardiology, cardio-thoracic, non-cardio-thoracic surgery and anaesthesiology. Phase-II compared the efficiency of physicians in identifying evidence-based approach of managing perioperative anticoagulation. In total 168 physicians were randomised to CDSS (PERI-KOAG) or CONTROL.
MEASUREMENTS


Overall mean score and association of processing time and professional experience were analysed. The multiple-choice test consists of 11 cases and two correct answers per question were required to gain 100% success rate (=22 points).
MAIN RESULTS


In total 76 physicians completed the questionnaire (n = 42 PERI-KOAG; n = 34 CONTROL; attrition rate 54%). Overall mean score (max. 100% = 22 points) was significantly higher in PERI-KOAG compared to CONTROL (82 ± 15% vs. 70 ± 10%; 18 ± 3 vs. 15 ± 2 points; P = 0.0003). A longer processing time is associated with significantly increased overall mean scores in PERI-KOAG (≥33 min. 89 ± 10% (20 ± 2 points) vs. <33 min. 73 ± 15% (16 ± 3 points), P = 0.0005) but not in CONTROL (≥33 min. 74 ± 13% (16 ± 3 points) vs. <33 min. 69 ± 9% (15 ± 2 points), P = 0.11). Within PERI-KOAG, there is a tendency towards higher results within the more experienced group (>5 years), but no significant difference to less (≤5 years) experienced colleagues (87 ± 10% (19 ± 2 points) vs. 78 ± 17% (17 ± 4 points), P = 0.08). However, an association between professional experience and success rate in CONTROL has not been shown (71 ± 8% vs. 70 ± 13%, 16 ± 2 vs. 15 ± 3 points; P = 0.66).
CONCLUSIONS


CDSS significantly improved the identification of evidence-based treatment approaches. A precise usage of CDSS is mandatory to maximise efficiency.",2022,A longer processing time is associated with significantly increased overall mean scores in PERI-KOAG (≥33 min.,"['We enrolled physicians (anaesthesiologist (n\xa0=\xa073), trauma surgeons (n\xa0=\xa02), unknown (n\xa0=\xa01)) with different professional experience', 'Five University and 11 general hospitals in Germany', 'In total 76 physicians completed the questionnaire (n\xa0=\xa042 PERI-KOAG; n\xa0', 'In total 168 physicians']","['CDSS (PERI-KOAG', 'Clinical Decision Support System (CDSS']","['Overall mean score (max', 'professional experience and success rate', 'PERI-KOAG', 'Overall mean score and association of processing time and professional experience']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0586908', 'cui_str': 'Trauma surgeon'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0347985', 'cui_str': 'During values'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",168.0,0.0987973,A longer processing time is associated with significantly increased overall mean scores in PERI-KOAG (≥33 min.,"[{'ForeName': 'Lisa-Marie', 'Initials': 'LM', 'LastName': 'Buchner', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Goethe University, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Eun Ji', 'Initials': 'EJ', 'LastName': 'Park', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Goethe University, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Bendz', 'Affiliation': 'Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Englert', 'Affiliation': 'Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'von der Groeben', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Goethe University, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Vo', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Goethe University, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Schmitt', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Goethe University, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zacharowski', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Goethe University, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Börm', 'Affiliation': 'Börm Bruckmeier Verlag GmbH, Munich, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Stauber', 'Affiliation': 'Börm Bruckmeier Verlag GmbH, Munich, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bingold', 'Affiliation': 'Department of Anaesthesiology, Helios Dr. Horst Schmidt Hospital Wiesbaden, Wiesbaden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Booke', 'Affiliation': 'Department of Anaesthesiology, Hospital Bad Soden, Bad Soden, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Gerth', 'Affiliation': 'Department of Anaesthesiology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Clemens-Alexander', 'Initials': 'CA', 'LastName': 'Greim', 'Affiliation': 'Department of Anaesthesiology, Hospital Fulda, Fulda, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mersmann', 'Affiliation': 'Department of Anaesthesiology, Hochtaunus Hospital Bad Homburg, Bad Homburg, Germany.'}, {'ForeName': 'Ralf Michael', 'Initials': 'RM', 'LastName': 'Muellenbach', 'Affiliation': 'Department of Anaesthesiology, Hospital Kassel, Kassel, Germany.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Mutlak', 'Affiliation': 'Department of Anaesthesiology, Sanaklinikum Offenbach, Offenbach, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Ott', 'Affiliation': 'Department of Anaesthesiology, BG Unfallklinik Murnau, Murnau, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pape', 'Affiliation': 'Department of Anaesthesiology, Sankt Katharinen Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sander', 'Affiliation': 'Department of Anaesthesiology, University Hospital Gießen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Teßmann', 'Affiliation': 'Department of Anaesthesiology, BG Unfallklinik Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Welte', 'Affiliation': 'Department of Anaesthesiology, Hospital Darmstadt, Darmstadt, Germany.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Wermelt', 'Affiliation': 'Department of Anaesthesiology, Bürgerhospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Hinnerk', 'Initials': 'H', 'LastName': 'Wulf', 'Affiliation': 'Department of Anaesthesiology, University Hospital Marburg, Marburg, Germany.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Choorapoikayil', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Goethe University, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Füllenbach', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Goethe University, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Goethe University, University Hospital Frankfurt, Frankfurt am Main, Germany; Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, Wuerzburg, Germany. Electronic address: meybohm_p@ukw.de.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2022.110877']
1102,35579606,Comparison of moderate and vigorous walking exercise on reducing depression in middle-aged and older adults: A pilot randomized controlled trial.,"The optimal intensity of physical activity for alleviating depression in middle-aged and older adults remains unclear. The World Health Organization (WHO) physical activity guidelines recommend adults and older adults to accumulate at least 150-300 minutes of moderate or 75-150 minutes of vigorous aerobic-type physical activity weekly or an equivalent combination of both for health benefits including reduced risk of depression. This parallel, assessor-blinded, pilot randomized controlled trial preliminarily compared the effectiveness of the minimal volume of aerobic-type physical activity at different intensities as recommended by WHO (150 minutes of moderate walking exercise and 75 minutes of vigorous walking exercise weekly) on alleviating depression in middle-aged and older adults. Thirty-five participants were randomized to the control group (CON), moderate walking exercise group (MOD), or vigorous walking exercise group (VIG). The exercise frequency was three times a week and the intervention duration was 12 weeks. The primary outcome was the severity of depression assessed by Beck Depression Inventory. Secondary outcomes included severity of anxiety, sleep quality, quality of life, and cardiorespiratory fitness. Thirty participants completed the study (CON:  n  = 10, MOD:  n  = 10, VIG:  n  = 10). Participants in both MOD and VIG had significantly decreased depression severity after the intervention compared to CON (both  p  < 0.001). There was no significant difference between MOD and VIG ( p  = 0.92). Both MOD and VIG interventions also mitigated anxiety severity, improved quality of life and cardiorespiratory fitness. The minimum volume of walking exercise at either moderate or vigorous intensity was found to alleviate depression in middle-aged and older adults. Trial registration:  ClinicalTrials.gov identifier: NCT04403373. HighlightsThe 12-week 150-minute moderate walking exercise and 75-minute vigorous walking exercise (the minimal weekly volumes of aerobic-type physical activity recommended by WHO guidelines) similarly reduced the severity of depression in middle-aged and older adults.The 12-week walking exercise interventions significantly reduced anxiety severity concomitant with improved quality of life and cardiorespiratory fitness in middle-aged and older adults with depression.",2022,Participants in both MOD and VIG had significantly decreased depression severity after the intervention compared to CON (both p < 0.001).,"['Middle-aged and older adults diagnosed with depression', 'middle-aged and older adults', 'adults and older adults', 'Thirty participants completed the study (CON: n\u2009=\u200910, MOD: n\u2009=\u200910, VIG: n\u2009=\u200910']","['aerobic-type physical activity at different intensities as recommended by WHO (150 minutes of moderate walking exercise and 75 minutes of vigorous walking exercise weekly', 'moderate and vigorous physical activity', 'control group (CON), moderate walking exercise group (MOD), or vigorous walking exercise group (VIG', 'CON', 'moderate and vigorous walking exercise']","['alleviating depression', 'depression severity', 'minimum volume of walking exercise', 'severity of depression assessed by Beck Depression Inventory', 'depression', 'MOD and VIG', 'quality of life and cardiorespiratory fitness', 'severity of anxiety, sleep quality, quality of life, and cardiorespiratory fitness']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231956', 'cui_str': 'Minimum volume'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",30.0,0.0403776,Participants in both MOD and VIG had significantly decreased depression severity after the intervention compared to CON (both p < 0.001).,"[{'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Yu', 'Affiliation': ""Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Angus P', 'Initials': 'AP', 'LastName': 'Yu', 'Affiliation': ""Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Chit K', 'Initials': 'CK', 'LastName': 'Leung', 'Affiliation': ""Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Edwin C', 'Initials': 'EC', 'LastName': 'Chin', 'Affiliation': ""Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Daniel Y', 'Initials': 'DY', 'LastName': 'Fong', 'Affiliation': ""School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Calvin P', 'Initials': 'CP', 'LastName': 'Cheng', 'Affiliation': ""Department of Psychiatry, Queen Mary Hospital, Hong Kong, People's Republic of China.""}, {'ForeName': 'Suk Y', 'Initials': 'SY', 'LastName': 'Yau', 'Affiliation': ""Department of Rehabilitation Sciences, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong, People's Republic of China.""}, {'ForeName': 'Parco M', 'Initials': 'PM', 'LastName': 'Siu', 'Affiliation': ""Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, People's Republic of China.""}]",European journal of sport science,['10.1080/17461391.2022.2079424']
1103,35584294,Continuous Positive Airway Pressure for Cognition in Sleep Apnea and Mild Cognitive Impairment: A Pilot Randomized Crossover Clinical Trial.,,2022,,['Sleep Apnea and Mild Cognitive Impairment'],['CPAP'],[],"[{'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]",[],,0.0784401,,"[{'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'The University of Sydney Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathan E', 'Initials': 'NE', 'LastName': 'Cross', 'Affiliation': 'The University of Sydney Sydney, New South Wales, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Terpening', 'Affiliation': 'The University of Sydney Sydney, New South Wales, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': ""D'Rozario"", 'Affiliation': 'The University of Sydney Sydney, New South Wales, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Woolcock Institute of Medical Research Sydney, New South Wales, Australia.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'LaMonica', 'Affiliation': 'The University of Sydney Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Marshall', 'Affiliation': 'The University of Sydney Sydney, New South Wales, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'The University of Sydney Sydney, New South Wales, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Naismith', 'Affiliation': 'The University of Sydney Sydney, New South Wales, Australia.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202111-2646LE']
1104,35586992,"Preclinical 3D-printed laboratory simulation of deep caries and the exposed pulp reduced student anxiety and stress, while increasing confidence and knowledge in vital pulp treatment.","AIM


To evaluate the impact of a preclinical laboratory session using 3D printed teeth on dental student stress, anxiety, confidence and knowledge when treating deep caries and pulp exposure.
METHODOLOGY


This was a two-centre controlled study, with randomized distribution of students into two groups: a vital pulp treatment (VPT) lecture-only (control) group and a VPT-lecture combined with a VPT-laboratory (experimental) group. In both universities, preclinical students with endodontic or operative dentistry laboratory sessions could participate. All students were invited to the lecture. Two weeks later (timepoint-T1), both groups completed validated and bespoke questionnaires and scales to evaluate their stress (Stress-VAS), anxiety (STAI Trait [T] and State [S]), self-confidence and knowledge. Thereafter, only the experimental group attended the hands-on laboratory session demonstrating the techniques of selective caries removal and partial pulpotomy on a commercial 3D-printed tooth. Two weeks later (timepoint-T2), the participants from both groups repopulated the same questionnaires and VAS. The control group had the laboratory session after the completion of the study. The statistical analysis was performed with Statistica® (significance p = .05). The homogeneity between the two samples was checked by Khi 2  and Student tests. Stress-VAS, STAI-S, confidence and knowledge scores were compared within each group, and between the two groups, at T1 and T2, with a repeated measures anova test (+/-Tukey post-hoc test).
RESULTS


The groups comprised 54 students each, with no statistical difference between the groups regarding demographic, academic data and STAI-T score. The two groups had no significant difference of Stress-VAS, STAI-S, confidence and knowledge scores at T1 while they presented a significant difference in stress, anxiety and confidence scores at T2, but with no significant difference in knowledge score. However, knowledge score, as other parameters, improved significantly between T1 and T2 in the experimental group.
CONCLUSIONS


The addition of a laboratory session using 3D-printed teeth that simulated deep caries and pulp exposure management, significantly reduced the stress and anxiety of students and increased their confidence. Within the limitations of this study, the benefit of introducing new technology in increasing student confidence and reducing stress offers opportunity for educational improvement in the VPT and cariology areas.",2022,"The two groups had no significant difference of Stress-VAS, STAI-S, confidence and knowledge scores at T1 while they presented a significant difference of stress, anxiety and confidence scores at T2, but with no significant difference in knowledge score.",[],['vital pulp treatment (VPT) lecture-only (control) group and a VPT-lecture combined with a VPT-laboratory (experimental) group'],"['stress, anxiety and confidence scores', 'dental student stress, anxiety, confidence and knowledge', 'Stress-VAS, STAI-S, confidence and knowledge scores', 'demographic, academic data and STAI-T score', 'stress and anxiety of students and increased their confidence', 'bespoke questionnaires and scales to evaluate their stress (Stress-VAS), anxiety (STAI Trait (T) and State (S)), self-confidence and knowledge', 'knowledge score']",[],"[{'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C1306815', 'cui_str': 'Pulp treatment'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",54.0,0.0172245,"The two groups had no significant difference of Stress-VAS, STAI-S, confidence and knowledge scores at T1 while they presented a significant difference of stress, anxiety and confidence scores at T2, but with no significant difference in knowledge score.","[{'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Chevalier', 'Affiliation': 'Brest University Hospital, University of Bretagne Occidentale, Brest, France.'}, {'ForeName': 'Marjolaine', 'Initials': 'M', 'LastName': 'Dessert', 'Affiliation': 'Brest University Hospital, University of Bretagne Occidentale, Brest, France.'}, {'ForeName': 'Kevin John', 'Initials': 'KJ', 'LastName': 'Fouillen', 'Affiliation': 'Brest University Hospital, University of Bretagne Occidentale, Brest, France.'}, {'ForeName': 'Sile', 'Initials': 'S', 'LastName': 'Lennon', 'Affiliation': 'Division of Restorative Dentistry and Periodontology, Trinity College Dublin, Dublin Dental University Hospital, Dublin 2, Ireland.'}, {'ForeName': 'Henry Fergus', 'Initials': 'HF', 'LastName': 'Duncan', 'Affiliation': 'Division of Restorative Dentistry and Periodontology, Trinity College Dublin, Dublin Dental University Hospital, Dublin 2, Ireland.'}]",International endodontic journal,['10.1111/iej.13780']
1105,35587650,Plain language summary of the HERO study comparing relugolix with leuprolide for men with advanced prostate cancer.,"WHAT IS THIS SUMMARY ABOUT?


This is a summary of a research study (known as a clinical trial) called HERO. The HERO study compared how well relugolix and leuprolide worked in lowering blood testosterone to sustained castration levels in men with advanced prostate cancer. Sustained castration is a blood testosterone level below 50 ng/dl from Day 29 through 48 weeks of treatment.
WHAT WERE THE RESULTS?


Researchers looked at 930 adult men with advanced prostate cancer: 622 of these men took relugolix (by mouth once daily) and 308 received leuprolide (injected every 3 months). The HERO study showed that more men taking relugolix (97%) achieved sustained castration through 48 weeks than men receiving leuprolide (89%). This decrease in testosterone also happened more quickly in men taking relugolix. In 184 men who were followed up for 90 days after completing treatment, blood levels of testosterone returned to normal in more men who took relugolix than men who received leuprolide. Side effects were similar among men taking relugolix or receiving leuprolide, and most were identified as mild or moderate in terms of how bad they were.
WHAT DO THE RESULTS OF THE STUDY MEAN?


In men with advanced prostate cancer and compared with those receiving leuprolide, more men taking relugolix had lower levels of blood testosterone. ClinicalTrials.gov NCT number: NCT03085095.",2022,"In 184 men who were followed up for 90 days after completing treatment, blood levels of testosterone returned to normal in more men who took relugolix than men who received leuprolide.","['184 men', 'men with advanced prostate cancer', '930 adult men with advanced prostate cancer']","['relugolix and leuprolide', 'relugolix with leuprolide', 'leuprolide']","['blood testosterone level', 'testosterone', 'Side effects', 'blood levels of testosterone', 'blood testosterone']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}]","[{'cui': 'C0853134', 'cui_str': 'Blood testosterone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",930.0,0.157582,"In 184 men who were followed up for 90 days after completing treatment, blood levels of testosterone returned to normal in more men who took relugolix than men who received leuprolide.","[{'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sutton', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC, USA.'}]","Future oncology (London, England)",['10.2217/fon-2022-0172']
1106,35569516,Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use.,"BACKGROUND


Extending hormonal intrauterine system duration will allow users to have less need for procedures to provide long-term contraception.
OBJECTIVE


This study aimed to evaluate the efficacy and safety of the levonorgestrel 52 mg intrauterine system during years 7 and 8 of use.
STUDY DESIGN


A total of 1751 nulliparous and multiparous participants aged 16 to 45 years enrolled in a phase 3, multicenter trial to evaluate the efficacy and safety of the use of the Liletta levonorgestrel 52 mg intrauterine system for up to 10 years. Participants aged 36 to 45 years at enrollment underwent safety evaluation only. After the first year, we evaluated participants every 6 months for intrauterine system location confirmation and urine pregnancy testing at each visit. We assessed the Pearl Indices in years 7 and 8 and the life-table analysis for cumulative pregnancy rates through 8 years of use. For the primary efficacy analyses, all participants aged 16 to 35 years at enrollment were included through year 6; years 7 and 8 included only users aged ≤39 years at the start of each use year. Safety outcomes were assessed in all participants regardless of duration of use. We assessed amenorrhea rates, defined as no bleeding or spotting in the 90 days before the end of the year.
RESULTS


After intrauterine system placement, we followed 1568 participants aged 16 to 35 years and 146 participants aged 36 to 45 years. The 16- to 35-year-old participants included 986 (57.5%) nulliparous and 433 (25.3%) obese users. Overall, 569 participants started year 7478 completed year 7 (380 aged ≤39 years at beginning of year) and 343 completed year 8 (257 aged ≤39 years at beginning of year); 77 completed 10 years of use. Eleven pregnancies occurred over 8 years, 7 (64%) of which were ectopic. Two pregnancies occurred in year 7 (Pearl Index, 0.49; 95% confidence interval, 0.06-1.78), 1 in a participant with implantation 4 days after a desired removal; no pregnancies occurred in year 8. The cumulative life-table pregnancy rate in the primary efficacy population through year 8 was 1.32 (95% confidence interval, 0.69-2.51); without the postremoval pregnancy, the rate was 1.09 (95% confidence interval, 0.56-2.13). Two perforations (0.1%) occurred, none noted after year 1. Expulsion occurred in 71 (4.1%) participants overall, with 3 in year 7 and 2 in year 8. Pelvic infection was diagnosed in 16 (0.9%) participants during intrauterine system use, 1 each in years 7 and 8. Only 44 (2.6%) participants overall discontinued because of bleeding complaints (4 total in years 7 and 8) with rates per year of 0.1% to 0.5% for years 3 to 8. Amenorrhea rates were 39% at both years 7 and 8.
CONCLUSION


The levonorgestrel 52 mg intrauterine system is highly effective over 8 years of use and has an excellent extended safety profile. This report details the longest period of efficacy and safety data for continuous use of a levonorgestrel 52 mg intrauterine system for contraception.",2022,Only 44 (2.6%) participants overall discontinued due to bleeding complaints (4 total in years 7 and 8) with rates per year of 0.1-0.5% for years 3-8.,"['1751 nulliparous and multiparous 16-45 year old participants enrolled in a phase 3 multicenter trial', '569 participants started year 7, 478 completed year 7 (380 age 39 or less at beginning of year), and 343 completed year 8 (257 age 39 or less at beginning of year); 77 completed 10 years of use', 'participants 16-35 years at enrollment were included through year 6; years 7 and 8 included only users 39 years or less at the start of each use year', '1568 participants aged 16-35 years and 146 participants aged 36-45 years', 'The 16-35 year old participants included 986 (57.5%) nulliparous and 433 (25.3%) obese users', 'Participants aged 36-45 years at enrollment underwent safety evaluation only']","['Levonorgestrel', 'Liletta levonorgestrel 52 mg IUS', 'levonorgestrel 52 mg IUS']","['Amenorrhea rates', 'bleeding complaints', 'Expulsion', 'Safety outcomes', 'efficacy and safety', 'cumulative life-table pregnancy rate', 'amenorrhea rates, defined as no bleeding or spotting', 'Pelvic infection']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C3892967', 'cui_str': 'Liletta'}, {'cui': 'C0937459', 'cui_str': 'Levonorgestrel 833 nanogram/hour prolonged-release intrauterine drug delivery system'}]","[{'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023683', 'cui_str': 'Life Tables'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0030790', 'cui_str': 'Infection of pelvis'}]",1751.0,0.171725,Only 44 (2.6%) participants overall discontinued due to bleeding complaints (4 total in years 7 and 8) with rates per year of 0.1-0.5% for years 3-8.,"[{'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA. Electronic address: mdcreinin@ucdavis.edu.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Turok', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, The University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cwiak', 'Affiliation': 'Division of Complex Family Planning, Department of Gynecology and Obstetrics, Emory University, Atlanta, GA.'}, {'ForeName': 'Beatrice A', 'Initials': 'BA', 'LastName': 'Chen', 'Affiliation': 'Division of Gynecologic Specialties, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh and Magee-Womens Research Institute, Pittsburgh, PA.'}, {'ForeName': 'Andrea I', 'Initials': 'AI', 'LastName': 'Olariu', 'Affiliation': 'Medicines360, San Francisco, CA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2022.05.022']
1107,35574656,"Timing of Circumcision and Breastfeeding Frequency: A Multicenter, Randomized Clinical Trial.","OBJECTIVE


To date, there is little in the literature that describes any relationship between newborn circumcision, its timing, and breastfeeding outcomes. We sought to determine if the timing of circumcision in term, healthy newborns affects exclusive breastfeeding rates during the first 6 months of life.
METHODS


One hundred and forty-eight maternal-infant dyads were enrolled in a randomized, multicenter, clinical trial between June 2016 and July 2019. Study participants included parent-infant dyads who desired both circumcision and breastfeeding. Newborns were randomized into 3 groups for circumcision: ""early,"" circumcised within 24 hours of delivery; ""intermediate,"" circumcised between 24 to 72 hours of age; and ""late,"" circumcised between 1 and 3 weeks of age. The primary outcome was exclusive breastfeeding duration, assessed at discharge, 2 weeks, and 2, 4, and 6 months.
RESULTS


Baseline characteristics between groups were similar. Exclusive breastfeeding decreased more rapidly over 6 months in the intermediate group (by 74%, 89% to 23%), as compared to the early (by 34%, 81% to 53%) or late (by 50%, 88% to 44%) groups (P = .04). Exclusive breastfeeding was less common in the intermediate group (circumcision between 24 and 72 hours), as compared to the early and late circumcision groups, at each measured time point beyond 2 weeks of age.
CONCLUSIONS


Circumcision before 24 hours of age may be advantageous with respect to increased exclusive breastfeeding throughout the first 6 months of life. Deferral of circumcision beyond the immediate newborn period was not superior to performing the procedure within the first 24 hours.",2022,"Exclusive breastfeeding decreased more rapidly over 6 months in the intermediate group (by 74%, 89% to 23%), as compared to the early (by 34%, 81% to 53%) or late (by 50%, 88% to 44%) groups (P = .04).","['healthy newborns', 'Newborns', 'One hundred and forty-eight maternal-infant dyads', 'Study participants included parent-infant dyads who desired both circumcision and breastfeeding']",['Circumcision and Breastfeeding Frequency'],"['exclusive breastfeeding duration, assessed at discharge, 2 weeks, and 2, 4, and 6 months', 'Exclusive breastfeeding']","[{'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",,0.0816567,"Exclusive breastfeeding decreased more rapidly over 6 months in the intermediate group (by 74%, 89% to 23%), as compared to the early (by 34%, 81% to 53%) or late (by 50%, 88% to 44%) groups (P = .04).","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mondzelewski', 'Affiliation': 'Naval Medical Center, San Diego, California.'}, {'ForeName': 'Thornton', 'Initials': 'T', 'LastName': 'Mu', 'Affiliation': 'Uniformed Services University, Bethesda, Maryland.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Michalski', 'Affiliation': 'Naval Medical Center, San Diego, California.'}, {'ForeName': 'Josiah', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riffenburgh', 'Affiliation': 'San Diego State University, San Diego, California.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Holmes', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}]",Hospital pediatrics,['10.1542/hpeds.2021-006400']
1108,35577602,Evaluation of the Pharmacokinetic Profile of Ultra Rapid Lispro Administered Subcutaneously at Different Injection Sites.,"PURPOSE


Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the pharmacokinetic profile and glucodynamic response of URLi when administered subcutaneously into the abdomen, upper arm, or thigh. An intravenous (IV) bolus administration was included to determine the absolute bioavailability at each injection site.
METHODS


In this Phase I, randomized, open-label, 4-period, crossover study, healthy subjects received a single dose of 15 U URLi subcutaneously into the abdomen, upper arm, or thigh, or by intravenous injection. Serum insulin lispro concentrations and glucodynamic response during a 10-hour euglycemic clamp procedure were assessed after URLi administration.
FINDINGS


Total insulin lispro exposure was similar for the abdomen, upper arm, and thigh, and absolute bioavailability was ∼65% at each subcutaneous (SC) injection site. Total and peak insulin action were similar across these SC injection sites. The onset of appearance was <1 minute, and the time to early half-maximal drug concentration occurred at ∼10 minutes across these three SC injection sites. Onset of insulin action occurred at ∼22 minutes, and the early insulin action (for the first hour) was also similar across these SC injection sites. URLi was well tolerated after single SC injections and IV bolus administration.
IMPLICATIONS


The pharmacokinetic and glucodynamic profiles of URLi were similar after a single SC dose into the abdomen, upper arm, or thigh. The rate of insulin lispro absorption and early insulin action were maintained regardless of the SC injection site. The current study supports SC injection of URLi into the abdomen, upper arm, and thigh.
CLINICALTRIALS


gov identifier: NCT03232983.",2022,"FINDINGS


Total insulin lispro exposure was similar for the abdomen, upper arm, and thigh, and absolute bioavailability was ∼65% at each subcutaneous (SC) injection site.",['healthy subjects'],"['Ultra rapid lispro (URLi', 'URLi', 'Ultra Rapid Lispro Administered', '2022;44:XXX-XXX']","['Total and peak insulin action', 'absolute bioavailability', 'pharmacokinetic and glucodynamic profiles of URLi', 'Serum insulin lispro concentrations and glucodynamic response', 'rate of insulin lispro absorption and early insulin action', 'time to early half-maximal drug concentration', 'early insulin action', 'Onset of insulin action']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",,0.0547201,"FINDINGS


Total insulin lispro exposure was similar for the abdomen, upper arm, and thigh, and absolute bioavailability was ∼65% at each subcutaneous (SC) injection site.","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. Electronic address: leohr_jennifer_k@lilly.com.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2022.04.001']
1109,35579535,Covid-19 outbreak: does the use of a surgical mask impact the sense of smell?,"BACKGROUND


The current context of Covid-19 pandemic has broadened mask use.
OBJECTIVES


Evaluate the impact of wearing a surgical mask on sense of smell by comparing the results of sniffin' sticks test (SST) with and without a surgical mask and evaluate the feasibility of practicing SST with a mask.
MATERIAL AND METHODS


A crossover prospective comparative study between two groups of volunteers. The results of SST with a mask were compared to the results without a mask: group 1 first performed SST with a surgical mask and then one week later performed SST without a mask, while group 2 started without a mask.
RESULTS


Twenty volunteers were included. In group 1 and 2, all the subjects, except one, had a significantly better total score (TDI) without a mask. The average TDI difference score with and without a mask, was inferior to 5. 8/20 (40%) subjects had a TDI difference superior to 5 with and without mask, while 4/20 (20%) were normosmic without a mask, while being recategorized as hyposmic with a mask.
CONCLUSIONS AND SIGNIFICANCE


Wearing a surgical mask may reduce the sense of smell, in a cohort of normosmic patients. Further larger studies must be conducted in hyposmic subjects.",2022,"In group 1 and 2, all the subjects, except one, had a significantly better total score (TDI) without a mask.","['two groups of volunteers', 'Twenty volunteers were included']","['wearing a surgical mask', 'practicing SST with a mask']","['total score (TDI', 'average TDI difference score']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}]",20.0,0.0417047,"In group 1 and 2, all the subjects, except one, had a significantly better total score (TDI) without a mask.","[{'ForeName': 'Clémentine', 'Initials': 'C', 'LastName': 'Hyvrard', 'Affiliation': ""Service d'ORL et de chirurgie cervico-faciale, Centre Hospitalier Intercommunal de Créteil, Créteil, France.""}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Petitjean', 'Affiliation': ""Service d'ORL et de chirurgie cervico-faciale, Centre Hospitalier Intercommunal de Créteil, Créteil, France.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Fieux', 'Affiliation': ""Service d'ORL, d'otoneurochirurgie et de chirurgie cervico-faciale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Bénite cedex, France.""}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Zerah', 'Affiliation': 'INSERM U955, Créteil, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Coste', 'Affiliation': ""Service d'ORL et de chirurgie cervico-faciale, Centre Hospitalier Intercommunal de Créteil, Créteil, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bartier', 'Affiliation': ""Service d'ORL et de chirurgie cervico-faciale, Centre Hospitalier Intercommunal de Créteil, Créteil, France.""}]",Acta oto-laryngologica,['10.1080/00016489.2022.2071462']
1110,35579509,"Transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection: a double-blinded, phase 2 randomized, controlled trial.","BACKGROUND


The efficacy of SARS-CoV-2 convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. CCP might prevent infection when administered before symptoms or laboratory evidence of infection.
METHODS


This double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320 by Euroimmun ELISA) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed COVID-19 in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was new SARS-CoV-2 infection.
RESULTS


180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for screening SARS-CoV-2 RT-PCR positivity. Of the remaining 168 participants, 12/81 (14·8%) CCP and 13/87 (14·9%) control recipients developed SARS-CoV-2 infection; 6 (7·4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25·3 vs. 25·2 days; p = 0·49) and COVID-19 (26·3 vs. 25·9 days; p = 0·35) was similar for both groups.
CONCLUSIONS


Administration of high-titer CCP as post-exposure prophylaxis, while appearing safe, did not prevent SARS-CoV-2 infection.",2022,Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25·3 vs. 25·2 days; p = 0·49) and COVID-19 (26·3,"['Of the remaining 168 participants', '180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021', 'Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed COVID-19 in the previous 120\u2005hours and negative SARS-CoV-2 test within 24\u2005hours before transfusion were eligible']","['SARS-CoV-2 convalescent plasma (CCP', 'prophylactic high titer (≥1:320 by Euroimmun ELISA) CCP with standard plasma', 'CCP']","['mean infection free time (RMIFT', 'SARS-CoV-2 infection', 'efficacy and safety', 'new SARS-CoV-2 infection', 'COVID-19-related hospitalizations']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",180.0,0.558769,Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25·3 vs. 25·2 days; p = 0·49) and COVID-19 (26·3,"[{'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Shoham', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Casadevall', 'Affiliation': 'Department of Molecular Microbiology and Immunology.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hanley', 'Affiliation': 'Department of Neurology, and the.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA, Mosaic Consulting Ltd., Israel.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gebo', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cachay', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases.'}, {'ForeName': 'Seble G', 'Initials': 'SG', 'LastName': 'Kassaye', 'Affiliation': 'Division of Infectious Diseases/Department of Medicine, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Paxton', 'Affiliation': 'Department of Emergency Medicine Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worchester, Massachusetts, USA.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Levine', 'Affiliation': 'Department of Emergency Medicine, Rhode Island Hospital/Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Naeim', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Currier', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division Critical Care Medicine, University of Texas Health, Houston, Texas, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Allen', 'Affiliation': 'Department of Pathology, University of California, San Diego, San Diego, California, USA.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Anjan', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Appel', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Sheriza', 'Initials': 'S', 'LastName': 'Baksh', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA, Mosaic Consulting Ltd., Israel.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Blair', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Broderick', 'Affiliation': 'Danbury Hospital.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Caputo', 'Affiliation': 'Department of Molecular Microbiology and Immunology.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Cluzet', 'Affiliation': 'Vassar Brothers Medical Center, Nuvance Health, Poughkeepsie, New York, USA.'}, {'ForeName': 'Marie Cordisco', 'Initials': 'MC', 'LastName': 'Elena', 'Affiliation': 'University of Vermont, Nuvance Health, Danbury, Connecticut, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cruser', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA, Mosaic Consulting Ltd., Israel.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Forthal', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Yuriko', 'Initials': 'Y', 'LastName': 'Fukuta', 'Affiliation': 'Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Gawad', 'Affiliation': 'Department of Neurology, and the.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gniadek', 'Affiliation': 'Department of Pathology, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hammel', 'Affiliation': 'Norwalk Hospital.'}, {'ForeName': 'Moises A', 'Initials': 'MA', 'LastName': 'Huaman', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'Department of Ophthalmology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jedlicka', 'Affiliation': 'Department of Molecular Microbiology and Immunology.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Karlen', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Sabra', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Department of Molecular Microbiology and Immunology.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': 'Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Lane', 'Initials': 'L', 'LastName': 'Karen', 'Affiliation': 'Department of Neurology, and the.'}, {'ForeName': 'Nichol', 'Initials': 'N', 'LastName': 'McBee', 'Affiliation': 'Department of Neurology, and the.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Meisenberg', 'Affiliation': 'Luminis Health, Annapolis, Maryland, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Merlo', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Mosnaim', 'Affiliation': 'Division of Allergy and Immunology, Department of Medicine.'}, {'ForeName': 'Han-Sol', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Molecular Microbiology and Immunology.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pekosz', 'Affiliation': 'Department of Molecular Microbiology and Immunology.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Petrini', 'Affiliation': 'Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, Maryland, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rausch', 'Affiliation': 'Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, Maryland, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shade', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA, Mosaic Consulting Ltd., Israel.'}, {'ForeName': 'Janna R', 'Initials': 'JR', 'LastName': 'Shapiro', 'Affiliation': 'Department of Molecular Microbiology and Immunology.'}, {'ForeName': 'Robinson J', 'Initials': 'RJ', 'LastName': 'Singleton', 'Affiliation': 'Department of Neurology, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sutcliffe', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA, Mosaic Consulting Ltd., Israel.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Thomas', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Yarava', 'Affiliation': 'Department of Neurology, and the.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zand', 'Affiliation': 'Department of Medicine, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Zenilman', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Aaron A R', 'Initials': 'AAR', 'LastName': 'Tobian', 'Affiliation': 'Department of Pathology.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sullivan', 'Affiliation': 'Department of Molecular Microbiology and Immunology.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciac372']
1111,35581535,Correction: Effects of a staged integral art-based cognitive intervention (SIACI) program in older adults with cognitive impairments: protocol for a randomized controlled trial.,,2022,,['older adults with cognitive impairments'],['staged integral art-based cognitive intervention (SIACI) program'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.109729,,"[{'ForeName': 'Yuan-Jiao', 'Initials': 'YJ', 'LastName': 'Yan', 'Affiliation': 'Research Center for Nursing Theory and Practice, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No. 134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Ming-Ping', 'Initials': 'MP', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No. 134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Wen-Chao', 'Initials': 'WC', 'LastName': 'Cai', 'Affiliation': 'Department of Radiology, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No. 134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Chen-Shan', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'The School of Nursing, Fujian Medical University, No.88 Jiaotong Road, Fuzhou, 350004, Fujian Province, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Research Center for Nursing Theory and Practice, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No. 134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China.'}, {'ForeName': 'Yu-Fei', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Chinese Language and Literature, Xiamen University, No. 422 Siming South Road, Xiamen, 361005, Fujian Province, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Research Center for Nursing Theory and Practice, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No. 134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China. leehong99@126.com.'}]",BMC geriatrics,['10.1186/s12877-022-03109-0']
1112,35582884,"Hypertension and mobile application for self-care, self-efficacy and related knowledge.","Managing hypertension is not only concerned with lowering blood pressure (BP) by using antihypertensive medications but also aims at minimizing its consequences through adopting self-care. The aim of this study was to assess the effectiveness of mobile application on self-care, BP control, self-efficacy and hypertension-related knowledge among adult patients with hypertension. A randomized design, two groups, pretest-posttest, between subjects with a 1:1 allocation ratio was used. The sample was selected from cardiology clinics has completed the study. Using a block randomization method, 57 of the participants were assigned to the intervention group receiving the educational application intervention, and 59 of them were assigned to the control group receiving usual care. The study's findings showed that participants in the intervention group reported statistically significant higher self-care and knowledge scores than the participants in the control group after 8 weeks of receiving the study intervention. Additionally, compared with the control group participants, more participants in the intervention group demonstrated BP control. The educational application is effective in improving knowledge, self-care and BP control. The positive results indicate the value of integrating mobile applications in the care of patients with hypertension.",2022,"The educational application is effective in improving knowledge, self-care and BP control.","['patients with hypertension', 'adult patients with hypertension']","['control group receiving usual care', 'intervention group receiving the educational application intervention', 'mobile application']","['BP control', 'self-care, BP control, self-efficacy and hypertension-related knowledge', 'self-care and knowledge scores', 'blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.00934207,"The educational application is effective in improving knowledge, self-care and BP control.","[{'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Dwairej', 'Affiliation': 'Clinical Nursing Department, School of Nursing, University of Jordan, Queen Rania Street, Amman 11942, Jordan.'}, {'ForeName': 'Muayyad', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Clinical Nursing Department, School of Nursing, University of Jordan, Queen Rania Street, Amman 11942, Jordan.'}]",Health education research,['10.1093/her/cyac012']
1113,35588930,Three days of beam walking practice improves dynamic balance control regardless of the use of haptic anchors in older adults.,"Balance deficits during walking increase the risk of falls in older adults. Providing haptic information through anchors improves dynamic balance control, but the benefits of practicing with anchors during walking need to be evaluated. We investigated the effect of practice with haptic anchors in the beam walking task in older adults. Twenty-five older adults participated in this study divided into 0% (G0, practice without the anchors) and 50% (G50, practice with the haptic anchors in 50% of the trials) groups. With the anchors, participants held in each hand a cable with a mass of 0.125 kg affixed to the end of the cable that contacted the ground. They walked and kept the anchors in contact with the ground such that they dragged them. Participants increased the distance walked on the beam and reduced the trunk angular acceleration after training, but this effect was independent of the anchors. The use of haptic anchors during beam walking training did not significantly affect older adults' performance and dynamic balance control. Both groups showed improvements in the post-test and 24-hr retention conditions, indicating that older adults can learn to adapt their gait to more challenging contexts.",2022,"Participants increased the distance walked on the beam and reduced the trunk angular acceleration after training, but this effect was independent of the anchors.","['older adults', 'Twenty-five older adults']","['beam walking practice', 'haptic anchors during beam walking training']","['trunk angular acceleration', 'Balance deficits', ""older adults' performance and dynamic balance control""]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",25.0,0.0253615,"Participants increased the distance walked on the beam and reduced the trunk angular acceleration after training, but this effect was independent of the anchors.","[{'ForeName': 'Geovana', 'Initials': 'G', 'LastName': 'Milani', 'Affiliation': 'Biomechanics and Motor Control Lab, School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Brazil.'}, {'ForeName': 'Andréia A S', 'Initials': 'AAS', 'LastName': 'Costa', 'Affiliation': 'Biomechanics and Motor Control Lab, School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Brazil; Graduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil; Center for Human Movement Sciences, University of Groningen Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Eduardo B', 'Initials': 'EB', 'LastName': 'Junqueira', 'Affiliation': 'Biomechanics and Motor Control Lab, School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Brazil.'}, {'ForeName': 'Eduardo G', 'Initials': 'EG', 'LastName': 'Campoi', 'Affiliation': 'Biomechanics and Motor Control Lab, School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Brazil; Graduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Henrique G', 'Initials': 'HG', 'LastName': 'Campoi', 'Affiliation': 'Biomechanics and Motor Control Lab, School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Brazil; Graduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Paulo R P', 'Initials': 'PRP', 'LastName': 'Santiago', 'Affiliation': 'Biomechanics and Motor Control Lab, School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Brazil; Graduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moraes', 'Affiliation': 'Biomechanics and Motor Control Lab, School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Brazil; Graduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil. Electronic address: renatomoraes@usp.br.'}]",Neuroscience letters,['10.1016/j.neulet.2022.136682']
1114,35588898,"Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study.","BACKGROUND


Due to the bleeding risk of full-dose systemic thrombolysis and the lack of major trials focusing on the clinical benefits of catheter-directed treatment, heparin antiocoagulation remains the standard of care for patients with intermediate-high-risk pulmonary embolism (PE).
METHODS AND RESULTS


The Higher-Risk Pulmonary Embolism Thrombolysis (HI-PEITHO) study (ClinicalTrials.gov Identifier: NCT04790370) is a multinational multicenter randomized controlled parallel-group comparison trial. Patients with: (1) confirmed acute PE; (2) evidence of right ventricular (RV) dysfunction on imaging; (3) a positive cardiac troponin test; and (4) clinical criteria indicating an elevated risk of early death or imminent hemodynamic collapse, will be randomized 1:1 to treatment with a standardized protocol of ultrasound-facilitated catheter-directed thrombolysis plus anticoagulation, vs anticoagulation alone. The primary outcome is a composite of PE-related mortality, cardiorespiratory decompensation or collapse, or non-fatal symptomatic and objectively confirmed PE recurrence, within 7 days of randomization. Further assessments cover, apart from bleeding complications, a broad spectrum of functional and patient-reported outcomes including quality of life indicators, functional status and the utilization of health care resources over a 12-month follow-up period. The trial plans to include 406 patients, but the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. As of May 11, 2022, 27 subjects have been enrolled. The trial is funded by Boston Scientific Corporation and through collaborative research agreements with University of Mainz and The PERT Consortium.
CONCLUSIONS


Regardless of the outcome, HI-PEITHO will establish the first-line treatment in intermediate-high risk PE patients with imminent hemodynamic collapse. The trial is expected to inform international guidelines and set the standard for evaluation of catheter-directed reperfusion options in the future.",2022,"Further assessments cover, apart from bleeding complications, a broad spectrum of functional and patient-reported outcomes including quality of life indicators and the utilization of health care resources over a 12-month follow-up period.","['patients with intermediate-high-risk pulmonary embolism (PE', 'Patients with', 'acute intermediate-high-risk pulmonary embolism', '27 subjects have been enrolled', '406 patients', 'intermediate-high risk PE patients with imminent hemodynamic collapse']","['Ultrasound-facilitated, catheter-directed thrombolysis versus anticoagulation alone', 'ultrasound-facilitated catheter-directed thrombolysis (USCDT) plus anticoagulation, versus anticoagulation alone']","['acute PE; (ii) evidence of right ventricular (RV) dysfunction on imaging', 'composite of PE-related mortality, cardiorespiratory decompensation or collapse, or non-fatal symptomatic and objectively confirmed PE recurrence', 'quality of life indicators and the utilization of health care resources']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",,0.341108,"Further assessments cover, apart from bleeding complications, a broad spectrum of functional and patient-reported outcomes including quality of life indicators and the utilization of health care resources over a 12-month follow-up period.","[{'ForeName': 'Frederikus A', 'Initials': 'FA', 'LastName': 'Klok', 'Affiliation': 'Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands; Center for Thrombosis and Heamostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Ní Ainle', 'Affiliation': 'Department of Haematology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Boston Scientific, Marlborough, MA.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Chauhan', 'Affiliation': 'Boston Scientific, Marlborough, MA.'}, {'ForeName': 'Binal', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'Boston Scientific, Marlborough, MA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barco', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland; Center for Thrombosis and Heamostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kucher', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Lang', 'Affiliation': 'Cardiology and Center of Cardiovascular Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schmidtmann', 'Affiliation': 'Institute for Medical Biostatistics, Epidemiology and Informatics, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Sterling', 'Affiliation': 'Department of Cardiovascular and Interventional Radiology, Inova Alexandria Hospital, VA.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Becker', 'Affiliation': 'Center for Thrombosis and Heamostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Center for Thrombosis and Heamostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Rosenfield', 'Affiliation': 'Division of Vascular Medicine and Intervention, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Stavros V', 'Initials': 'SV', 'LastName': 'Konstantinides', 'Affiliation': 'Center for Thrombosis and Heamostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany; Department of Cardiology, Democritus University of Thrace, Alexandroupolis, Greece. Electronic address: stavros.konstantinides@unimedizin-mainz.de.'}]",American heart journal,['10.1016/j.ahj.2022.05.011']
1115,35588897,Study design and rationale for the Olpasiran trials of Cardiovascular Events And lipoproteiN(a) reduction-DOSE finding study (OCEAN(a)-DOSE).,"BACKGROUND


Data support lipoprotein(a) (Lp[Lp(a)]) being a risk factor for atherosclerotic cardiovascular disease (ASCVD). Olpasiran is a small interfering RNA molecule that markedly reduces Lp(a) production in hepatocytes.
STUDY DESIGN


The Olpasiran trials of Cardiovascular Events And lipoproteiN(a) reduction-DOSE finding study is a multicenter, randomized, double-blind, placebo-controlled dose-finding study in 281 subjects with established ASCVD and Lp(a) > 150 nmol/L. Patients were randomly allocated to one of 4 active subcutaneous doses of olpasiran (10 mg q12 weeks, 75 mg q12 weeks, 225 mg q 12 weeks, or 225 mg q24 weeks) or matched placebo. The primary objective is to evaluate the effects of olpasiran dosed every 12 weeks compared with placebo on the percent change in Lp(a) from baseline at 36 weeks. Enrollment is now complete and follow-up is ongoing.
CONCLUSIONS


OCEAN(a)-DOSE trial is assessing the Lp(a)-lowering efficacy and safety of olpasiran. These data will be used to determine optimal dosing and design for a cardiovascular outcomes trial.",2022,"Olpasiran is a small interfering RNA molecule that markedly reduces Lp(a) production in hepatocytes.
",['281 subjects with established atherosclerotic disease and Lp(a) >150 nmol/L. Patients'],"['olpasiran', 'OCEAN(a)-DOSE', 'placebo']",[],"[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028814', 'cui_str': 'Oceans'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],281.0,0.58491,"Olpasiran is a small interfering RNA molecule that markedly reduces Lp(a) production in hepatocytes.
","[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA. Electronic address: modonoghue@bwh.harvard.edu.""}, {'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'G López', 'Affiliation': 'Global Development, Amgen, Thousand Oaks, CA.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knusel', 'Affiliation': 'Global Development, Amgen, Thousand Oaks, CA.'}, {'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': 'Cardiology Division, Geneva University Hospitals, Geneva, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Huei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Global Development, Amgen, Thousand Oaks, CA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Global Development, Amgen, Thousand Oaks, CA.'}, {'ForeName': 'Helina', 'Initials': 'H', 'LastName': 'Kassahun', 'Affiliation': 'Global Development, Amgen, Thousand Oaks, CA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA.""}]",American heart journal,['10.1016/j.ahj.2022.05.004']
1116,35578403,"The effect of sleep continuity disruption on multimodal emotion processing and regulation: a laboratory-based, randomised, controlled experiment in good sleepers.","Previous research shows that experimental sleep deprivation alters emotion processing, suggesting a potential mechanism linking sleep disruption to mental ill-health. Extending previous work, we experimentally disrupted sleep continuity in good sleepers and assessed next-day emotion processing and regulation using tasks with established sensitivity to depression. In a laboratory-based study, 51 good sleepers (37 female; mean [SD] age 24 [3.63] years), were randomised to 1 night of uninterrupted sleep (n = 24) or sleep continuity disruption (n = 27). We assessed emotion perception, attention, and memory the following day. Participants also completed an emotion regulation task and measures of self-reported affect, anxiety, sleepiness, overnight declarative memory consolidation, and psychomotor vigilance. Confirming the effects of the manipulation, sleep continuity disruption led to a marked decrease in polysomnography-defined total sleep time (229.98 versus 434.57 min), increased wake-time after sleep onset (260.66 versus 23.84 min), and increased sleepiness (d = 0.81). Sleep continuity disruption led to increased anxiety (d = 0.68), decreased positive affect (d = -0.62), reduced overnight declarative memory consolidation (d = -1.08), and reduced psychomotor vigilance (longer reaction times [d = 0.64] and more lapses [d = 0.74]), relative to control. However, contrary to our hypotheses, experimental sleep disruption had no effect on perception of, or bias for, emotional facial expressions, emotional memory for words, or emotion regulation following worry induction. In conclusion, 1 night of sleep continuity disruption had no appreciable effect on objective measures of emotion processing or emotion regulation in response to worry induction, despite clear effects on memory consolidation, vigilance, and self-reported affect and anxiety.",2022,"Sleep continuity disruption led to increased anxiety (d = 0.68), decreased positive affect (d = -0.62), reduced overnight declarative memory consolidation (d = -1.08), and reduced psychomotor vigilance (longer reaction times [d = 0.64] and more lapses [d = 0.74]), relative to control.",['51 good sleepers (37 female; mean [SD] age 24\xa0[3.63]\xa0years'],['sleep continuity disruption'],"['memory consolidation, vigilance, and self-reported affect and anxiety', 'reduced psychomotor vigilance', 'overnight declarative memory consolidation', 'emotion regulation task and measures of self-reported affect, anxiety, sleepiness, overnight declarative memory consolidation, and psychomotor vigilance', 'polysomnography-defined total sleep time', 'emotion processing or emotion regulation', 'emotion perception, attention, and memory', 'increased sleepiness', 'anxiety', 'perception of, or bias for, emotional facial expressions, emotional memory for words, or emotion regulation following worry induction', 'wake-time after sleep onset']","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",51.0,0.02904,"Sleep continuity disruption led to increased anxiety (d = 0.68), decreased positive affect (d = -0.62), reduced overnight declarative memory consolidation (d = -1.08), and reduced psychomotor vigilance (longer reaction times [d = 0.64] and more lapses [d = 0.74]), relative to control.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Reid', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, The University of Oxford, Oxford, UK.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Omlin', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, The University of Oxford, Oxford, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, The University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sharman', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, The University of Oxford, Oxford, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Tamm', 'Affiliation': 'Department of Psychiatry, The University of Oxford, Oxford, UK.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, The University of Oxford, Oxford, UK.'}]",Journal of sleep research,['10.1111/jsr.13634']
1117,35580297,AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With  EGFR  Exon 19 Deletion or L858R Mutations.,"PURPOSE


Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China. This double-blind phase III trial evaluated the efficacy and safety of aumolertinib compared with gefitinib as a first-line treatment for locally advanced or metastatic  EGFR -mutated non-small-cell lung cancer (NSCLC; ClinicalTrials.gov identifier: NCT03849768).
METHODS


Patients at 53 sites in China were randomly assigned 1:1 to receive either aumolertinib (110 mg) or gefitinib (250 mg) once daily. The primary end point was progression-free survival (PFS) per investigator assessment.
RESULTS


A total of 429 patients who were naïve to treatment for locally advanced or metastatic NSCLC were enrolled. PFS was significantly longer with aumolertinib compared with gefitinib (hazard ratio, 0.46; 95% CI, 0.36 to 0.60;  P  < .0001). The median PFS with aumolertinib was 19.3 months (95% CI, 17.8 to 20.8) versus 9.9 months with gefitinib (95% CI, 8.3 to 12.6). Objective response rate and disease control rate were similar in the aumolertinib and gefitinib groups (objective response rate, 73.8% and 72.1%, respectively; disease control rate, 93.0% and 96.7%, respectively). The median duration of response was 18.1 months (95% CI, 15.2 to not applicable) with aumolertinib versus 8.3 months (95% CI, 6.9 to 11.1) with gefitinib. Adverse events of grade ≥ 3 severity (any cause) were observed in 36.4% and 35.8% of patients in the aumolertinib and gefitinib groups, respectively. Rash and diarrhea (any grade) were observed in 23.4% and 16.4% of patients who received aumolertinib compared with 41.4% and 35.8% of those who received gefitinib, respectively.
CONCLUSION


Aumolertinib is a well-tolerated third-generation epidermal growth factor receptor tyrosine kinase inhibitor that could serve as a treatment option for  EGFR -mutant NSCLC in the first-line setting.",2022,"PFS was significantly longer with aumolertinib compared with gefitinib (hazard ratio, 0.46; 95% CI, 0.36 to 0.60;  P  < .0001).","['429 patients who were naïve to treatment for locally advanced or metastatic NSCLC were enrolled', 'locally advanced or metastatic  EGFR -mutated non-small-cell lung cancer (NSCLC', 'Locally Advanced or MetastaticNon-Small-Cell Lung Cancer With  EGFR', 'Patients at 53 sites in China']","['aumolertinib', 'Aumolertinib Versus Gefitinib', 'gefitinib']","['Rash and diarrhea', 'progression-free survival (PFS) per investigator assessment', 'median PFS with aumolertinib', 'disease control rate', 'median duration of response', 'efficacy and safety', 'Objective response rate and disease control rate', 'PFS', 'Adverse events of grade ≥ 3 severity (any cause']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",429.0,0.387543,"PFS was significantly longer with aumolertinib compared with gefitinib (hazard ratio, 0.46; 95% CI, 0.36 to 0.60;  P  < .0001).","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Department of Medical Oncology, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Cancer Center, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jian', 'Affiliation': 'Department of Medical Oncology, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology-Chest, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Thoracic Oncology Medicine, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Ziping', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Chest Medicine, Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Internal Medicine, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Junguo', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Departments of Respiratory Medicine, Nantong Tumor Hospital, Nantong, China.'}, {'ForeName': 'Shaoshui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Binzhou Medical University Hospital, Binzhou, China.'}, {'ForeName': 'Dongqing', 'Initials': 'D', 'LastName': 'Lv', 'Affiliation': 'Breath Internal Medicine, Taizhou Hospital of Zhejiang Province, Linhai, China.'}, {'ForeName': 'Guojun', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiration, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Chunling', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Lung Internal Medicine, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Oncology, Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Thoracic Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Department of Thoracic Oncology, The Fifth Subsidiary Sun Yat-sen University Hospital, Zhuhai, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Zhehai', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Jiuwei', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'Department of Oncology, The First Bethune Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xingxiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Respiration, Northern Jiangsu People's Hospital, The Affiliated Hospital to Yangzhou University, Yangzhou, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Chest Medicine, Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Internal Medicine, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Respiration, Xinqiao Hospital, The Second Affiliated Hospital of China PLA Army Medical University, Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department of Chest Internal Medicine, Liaoning Cancer Hospital & Institute, Shenyang, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Lung & Gastrointestinal Oncology Department, Hunan Cancer Hospital (The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University), Changsha, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, the Southwest Hospital of AMU, The First Affiliated Hospital of PLA Army Medical University, Chongqing, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Chengping', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Respiratory Medicine, Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiration Oncology, Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Respiration, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Respiration, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Renhua', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Oncology, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Baolan', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Oncology Internal Medicine, Beijing Chest Hospital, Capital Medical Hospital, Beijing, China.'}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Xiangya Second Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Wancheng', 'Initials': 'W', 'LastName': 'Tong', 'Affiliation': 'Department of Infection Internal Medicine, Nanfang Hospital, Nanfang Medical University, Guangzhou, China.'}, {'ForeName': 'Helong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, The Second Affiliated Hospital of Air Force Military Medical University, Xi'An, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Respiration, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Tongji Medical College Huazhong University of Science & Technology, Wuhan, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Jie', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Shanghai Fifth People's Hospital, Fudan University Shanghai, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""Department of Oncology Internal Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'An, China.""}, {'ForeName': 'Longzhen', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Radiotherapy Department, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Weng', 'Initials': 'W', 'LastName': 'Jie', 'Affiliation': 'Department of Oncology, Yueyang Central Hospital, Yueyang, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Xianwei', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, GuiZhou Provincial People's Hospital, Guiyang, China.""}, {'ForeName': 'Jianchun', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Internal Medicine, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Radiotherapy Section, Taizhou Hospital of Zhejiang Province, Linhai, China.'}, {'ForeName': 'Meili', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology Internal Medicine, Jinan Central Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Changan', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Hansoh Pharmaceutical Group Co. Ltd, Shanghai, China.'}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Hansoh Pharmaceutical Group Co. Ltd, Shanghai, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hansoh Pharmaceutical Group Co. Ltd, Shanghai, China.'}, {'ForeName': 'Siraj M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'EQRx, Inc, Cambridge, MA.'}, {'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'Miller', 'Affiliation': 'EQRx, Inc, Cambridge, MA.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Hansoh Pharmaceutical Group Co. Ltd, Shanghai, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.02641']
1118,35580701,Ketamine increases fronto-posterior functional connectivity during meta-perceptual confidence ratings.,"Recent advances in the neuropsychopharmacology of metacognition indicate a constituent role of glutamate for the integrity of metamnestic processes. However, the extent to which previous results can be generalized across functional domains to characterize the relationship between glutamate and metacognition remains unclear. Here, in a randomized, double-blind, placebo-controlled, preregistered fMRI study, we tested the effects of a psychotomimetic dose (target plasma concentration 100 ng/mL) of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine on metacognition in a perceptual decision-making framework. We collected trial-by-trial metacognitive reports as participants performed a two-alternative forced-choice perceptual task during functional magnetic resonance imaging (fMRI). Results indicated ketamine-induced deterioration in metacognitive performance, whereas no significant effects were observed for perceptual performance, response times and - unexpectedly - metacognitive bias. Whilst there were no detectable ketamine effects on mean BOLD activation, exploratory psychophysiological interaction (PPI) analysis revealed alterations in functional connectivity during metacognitive confidence ratings under ketamine. Specifically, there was increased task-specific connectivity for ketamine compared to placebo between right anterior dorsolateral prefrontal cortex and left middle temporal, supramarginal and precentral gyrus, as well as between right insula/inferior frontal gyrus and left lingual gyrus, possibly indicating re-representations of object-level features supplied for metacognitive evaluations. Overall, these findings contribute towards the emerging picture of the substructures underlying metacognitive operations at the neurotransmitter level and may shed light on a neural pattern characteristic of pharmacologically challenged metacognition.",2022,"Results indicated ketamine-induced deterioration in metacognitive performance, whereas no significant effects were observed for perceptual performance, response times and - unexpectedly - metacognitive bias.",[],"['psychotomimetic dose (target plasma concentration 100ng/mL) of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine', 'alternative forced-choice perceptual task during functional magnetic resonance imaging (fMRI', 'Ketamine', 'placebo', 'ketamine']","['functional connectivity during metacognitive confidence ratings', 'task-specific connectivity', 'fronto-posterior functional connectivity', 'mean BOLD activation, exploratory psychophysiological interaction (PPI', 'deterioration in metacognitive performance', 'perceptual performance, response times and - unexpectedly - metacognitive bias']",[],"[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0242910', 'cui_str': 'Glutamate receptor antagonist'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",,0.318537,"Results indicated ketamine-induced deterioration in metacognitive performance, whereas no significant effects were observed for perceptual performance, response times and - unexpectedly - metacognitive bias.","[{'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Lehmann', 'Affiliation': 'Department of Psychology, University of Bonn, Kaiser-Karl-Ring 9, 53111 Bonn, Germany. Electronic address: mirko_lehmann@uni-bonn.de.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Neumann', 'Affiliation': 'Department of Anesthesiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany. Electronic address: claudia.neumann@ukbonn.de.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Wasserthal', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany. Electronic address: sven.wasserthal@ukbonn.de.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Delis', 'Affiliation': 'Department of Anesthesiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany. Electronic address: achilles.delis@ukbonn.de.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schultz', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, Am Hofgarten 8, 53113 Bonn, Germany; Institute for Experimental Epileptology and Cognition Research, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany. Electronic address: johannes.schultz@ukbonn.de.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Department of Psychiatry, School of Medicine & Health Sciences, University of Oldenburg, Hermann-Ehlers-Str. 7, 26129 Oldenburg, Germany; Research Center Neurosensory Science, University of Oldenburg, 26129 Oldenburg, Germany. Electronic address: rene.hurlemann@uol.de.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': 'Department of Psychology, University of Bonn, Kaiser-Karl-Ring 9, 53111 Bonn, Germany. Electronic address: ulrich.ettinger@uni-bonn.de.'}]",Behavioural brain research,['10.1016/j.bbr.2022.113925']
1119,35584197,Improved executive function in patients with systemic lupus erythematosus following interactive digital training.,"OBJECTIVE


This study aimed to evaluate the sensitivity of a digital platform to assess attentional and executive function in systemic lupus erythematosus (SLE) patients, and to evaluate the impact of an at-home interactive digital treatment to improve cognitive dysfunction in this clinical population.
BACKGROUND


Deficits in attention and executive function are common in patients with SLE. Despite these cognitive difficulties, there are limited brief assessment techniques and few treatment options to improve cognitive abilities in patients with SLE. Interactive digital treatment approaches (use of video game-based software) have been successful in identifying and improving cognition in other clinical populations.
METHODS


Sixty SLE patients completed baseline neuropsychological tests (of attention, psychomotor speed, and executive function), a tablet-based digital platform (EVO TM  Monitor), and biobehavioral measures. The patients were randomized into treatment SLE ( n  = 30) or no contact control SLE ( n  = 30) groups, and returned 4 weeks later for follow-up cognitive, EVO Monitor, and biobehavioral testing. The SLE treatment group was trained on a tablet-based digital treatment (AKL-T01) and was instructed to complete 5 sessions at least 5 days per week for 4-weeks for a total of approximately 25 min of gameplay per day.
RESULTS


Systemic lupus erythematosus patients demonstrated impairment in visuomotor and processing speed, visual attention, and cognitive flexibility/sequencing skills at baseline. The video game-like treatment group (AKL-T01) had significant improvement in visuomotor speed (Trail Making A) and cognitive flexibility/sequencing (Trail Making B) compared to the control group at 4-week follow-up. The treatment group also demonstrated significant improvement in EVO Monitor multitasking at follow-up (with no change in controls). At baseline, a multitasking metric from EVO Monitor was associated with performance on tasks of cognitive flexibility (Trail Making B) and psychomotor speed (WAIS-IV Coding).
CONCLUSIONS


These findings provide evidence that SLE patients who participated in a 4-week interactive digital video game-like activity had significant improvement in motor speed and executive functions, and would benefit from participation in digital interventions designed to target frontoparietal networks of the brain. Preliminary findings also suggest specific metrics from EVO Monitor may also be useful to detect cognitive impairment and cognitive changes in patients with SLE.",2022,The treatment group also demonstrated significant improvement in EVO Monitor multitasking at follow-up (with no change in controls).,"['patients with systemic lupus erythematosus', 'systemic lupus erythematosus (SLE) patients', 'patients with SLE', 'Sixty SLE patients completed baseline neuropsychological tests (of attention, psychomotor speed, and executive function), a tablet-based digital platform (EVO TM  Monitor), and biobehavioral measures']","['no contact control SLE', 'interactive digital training', 'SLE', 'Interactive digital treatment approaches (use of video game-based software', 'digital platform']","['visuomotor speed (Trail Making A) and cognitive flexibility/sequencing (Trail Making B', 'motor speed and executive functions', 'EVO Monitor multitasking', 'tasks of cognitive flexibility (Trail Making B) and psychomotor speed (WAIS-IV Coding', 'cognitive abilities', 'impairment in visuomotor and processing speed, visual attention, and cognitive flexibility/sequencing skills', 'executive function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0204456', 'cui_str': 'Wechsler adult intelligence scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}]",60.0,0.069978,The treatment group also demonstrated significant improvement in EVO Monitor multitasking at follow-up (with no change in controls).,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kozora', 'Affiliation': '2930National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'JoAnn L', 'Initials': 'JL', 'LastName': 'Zell', 'Affiliation': 'Rheumatology, 12225University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baraghoshi', 'Affiliation': '2930National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': '2930National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Strand', 'Affiliation': '2930National Jewish Health, Denver, CO, USA.'}]",Lupus,['10.1177/09612033221098534']
1120,35587779,Fibro-inflammatory recovery and type 2 diabetes remission following a low calorie diet but not exercise training: A secondary analysis of the DIASTOLIC randomised controlled trial.,"AIMS


To investigate the relationship between fibro-inflammatory biomarkers and cardiovascular structure/function in people with Type 2 Diabetes (T2D) compared to healthy controls and the effect of two lifestyle interventions in T2D.
METHODS


Data were derived from the DIASTOLIC randomised controlled trial (RCT) and includes a comparison between those with T2D and the matched healthy volunteers recruited at baseline. Adults with T2D without cardiovascular disease (CVD) were randomized to a 12-week intervention either: (1) exercise training, (2) a low-energy (∼810 kcal/day) meal-replacement plan (MRP) or (3) standard care. Principal Component and Fisher's linear discriminant analysis were used to investigate the relationships between MRI acquired cardiovascular outcomes and fibro-inflammatory biomarkers in cases versus controls and pre- and post-intervention in T2D.
RESULTS


At baseline, 83 people with T2D (mean age 50.5 ± 6.4; 58% male) and 36 healthy controls (mean age 48.6 ± 6.2; 53% male) were compared and 76 people with T2D completed the RCT for pre- post-analysis. Compared to healthy controls, subjects with T2D had adverse cardiovascular remodelling and a fibro-inflammatory profile (20 differentially expressed biomarkers). The 3D data visualisations showed almost complete separation between healthy controls and those with T2D, and a marked shift towards healthy controls following the MRP (15 biomarkers significantly changed) but not exercise training.
CONCLUSIONS


Fibro-inflammatory pathways and cardiovascular structure/function are adversely altered before the onset of symptomatic CVD in middle-aged adults with T2D. The MRP improved the fibro-inflammatory profile of people with T2D towards a more healthy status. Long-term studies are required to assess whether these changes lead to continued reverse cardiac remodelling and prevent CVD.",2022,"The 3D data visualisations showed almost complete separation between healthy controls and those with T2D, and a marked shift towards healthy controls following the MRP (15 biomarkers significantly changed) but not exercise training.
","['people with Type 2 Diabetes (T2D', '83 people with T2D (mean age 50.5 ±\u20096.4; 58% male) and 36 healthy controls (mean age 48.6 ±\u20096.2; 53 % male) were compared and 76 people with T2D completed the RCT for pre- post-analysis', 'Adults with T2D without cardiovascular disease (CVD', 'Data were derived from the DIASTOLIC randomised controlled trial (RCT) and includes a comparison between those with T2D and the matched healthy volunteers recruited at baseline', 'middle-aged adults with T2D']","['low calorie diet but not exercise training', 'exercise training, 2) a low-energy (∼810 kcal/day) meal-replacement plan (MRP) or 3) standard care']",['adverse cardiovascular remodelling and a fibro-inflammatory profile'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",83.0,0.0396888,"The 3D data visualisations showed almost complete separation between healthy controls and those with T2D, and a marked shift towards healthy controls following the MRP (15 biomarkers significantly changed) but not exercise training.
","[{'ForeName': 'Emer M', 'Initials': 'EM', 'LastName': 'Brady', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Gaurav S', 'Initials': 'GS', 'LastName': 'Gulsin', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Evgeny M', 'Initials': 'EM', 'LastName': 'Mirkes', 'Affiliation': 'School of Mathematics and Actuarial Science, University of Leicester, Leicester, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Parke', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Prathap', 'Initials': 'P', 'LastName': 'Kanagala', 'Affiliation': 'University of Liverpool, Liverpool Centre for Cardiovascular Science, Liverpool, UK.'}, {'ForeName': 'Leong L', 'Initials': 'LL', 'LastName': 'Ng', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Matthew P M', 'Initials': 'MPM', 'LastName': 'Graham-Brown', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Athithan', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Henson', 'Affiliation': 'Diabetes Research Centre, NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Redman', 'Affiliation': 'Diabetes Research Centre, NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Jang', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Cardiovascular & Fibrosis Translational Research, Bristol, New Jersey, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Cardiovascular & Fibrosis Translational Research, Bristol, New Jersey, USA.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Argyridou', 'Affiliation': 'Diabetes Research Centre, NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14884']
1121,35589026,Data-driven quality improvement program to prevent hospitalisation and improve care of people living with coronary heart disease: Protocol for a process evaluation.,"BACKGROUND


Practice-level quality improvement initiatives using rapidly advancing technology offers a multidimensional approach to reduce cardiovascular disease burden. For the ""QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with heart disease"" (QUEL) cluster randomised controlled trial, a 12-month quality improvement intervention was designed for primary care practices to use data and implement progressive changes using ""Plan, Do, Study, Act"" cycles within their practices with training in a series of interactive workshops. This protocol aims to describe the systematic methods to conduct a process evaluation of the data-driven intervention within the QUEL study.
METHODS


A mixed-method approach will be used to conduct the evaluation. Quantitative data collected throughout the intervention period, via surveys and intervention materials, will be used to (1) identify the key elements of the intervention and how, for whom and in what context it was effective; (2) determine if the intervention is delivered as intended; and (3) describe practice engagement, commitment and capacity associated with various intervention components. Qualitative data, collected via semi-structured interviews and open-ended questions, will be used to gather in-depth understanding of the (1) satisfaction, utility, barriers and enablers; (2) acceptability, uptake and feasibility, and (3) effect of the COVID-19 pandemic on the implementation of the intervention.
CONCLUSION


Findings from the evaluation will provide new knowledge on the implementation of a complex, multi-component intervention at practice-level using their own electronic patient data to enhance secondary prevention of cardiovascular disease.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134.",2022,"For the ""QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with heart disease"" (QUEL) cluster randomised controlled trial, a 12-month quality improvement intervention was designed for primary care practices to use data and implement progressive changes using ""Plan, Do, Study, Act"" cycles within their practices with training in a series of interactive workshops.","['people living with coronary heart disease', 'people Living with heart disease"" (QUEL']",[],"['2) acceptability, uptake and feasibility, and (3) effect', 'Effectiveness and efficiency of care']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0309277,"For the ""QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with heart disease"" (QUEL) cluster randomised controlled trial, a 12-month quality improvement intervention was designed for primary care practices to use data and implement progressive changes using ""Plan, Do, Study, Act"" cycles within their practices with training in a series of interactive workshops.","[{'ForeName': 'Nashid', 'Initials': 'N', 'LastName': 'Hafiz', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Australia. Electronic address: nashid.hafiz@sydney.edu.au.'}, {'ForeName': 'Karice', 'Initials': 'K', 'LastName': 'Hyun', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Australia; Department of Cardiology, Concord Hospital, ANZAC Research Institute, Sydney, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Tu', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Primary and Integrated Care Unit, South Western Sydney Local Health District, Sydney, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hespe', 'Affiliation': 'The University of Notre Dame, School of Medicine, Sydney, Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Western Sydney Local Health District, Sydney, Australia; Westmead Applied Research Centre, Faculty of Medicine and Health, Westmead, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Briffa', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Gallagher', 'Affiliation': 'Sydney Nursing School, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Hare', 'Affiliation': 'University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'Primary and Integrated Care Unit, South Western Sydney Local Health District, Sydney, Australia; Faculty of Health Sciences & Medicine, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia; The George Institute for Global Health, School of Public Health, Imperial College London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Atkins', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Tracey-Lea', 'Initials': 'TL', 'LastName': 'Laba', 'Affiliation': 'University of Technology Sydney Centre for Health Economics Research and Evaluation, Sydney, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Halcomb', 'Affiliation': 'School of Nursing, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Inala Primary Care, Brisbane, QLD, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Usherwood', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia; Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Australia; The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106794']
1122,35589025,Bring Blood Glucose Down! An intervention to reduce fear of hypoglycemia in caregivers of adolescents with type 1 diabetes: Study design and participant characteristics.,"Fear of hypoglycemia (FOH) is anxiety or extreme worry about having a low blood glucose and its consequences. FOH is common in individuals with type 1 diabetes (T1D) of all ages, as well as their caregivers, and can lead to inappropriate T1D self-management and suboptimal health outcomes. Despite its prevalence and serious health consequences, there has been very little attention focused on developing interventions to reduce FOH and its associated maladaptive T1D management behaviors. The primary aim of the present study, Bring BG Down!, was to implement a pilot intervention targeting FOH in mothers of adolescents with T1D. Exploratory aims included determining if the intervention had an impact on the adolescent's FOH, glycemia, as well as other generalized anxiety symptoms or symptoms of obsessive-compulsive disorder in both the mother and adolescent. Caregiver participants and their adolescents with T1D were randomized to either the Bring BG Down! group or the Control group. Individuals in the Bring BG Down! group participated in intervention sessions for 6 months via telehealth and they completed questionnaires, whereas those in the Control group only completed questionnaires. Follow-up occurred at 7-months and 10-months. The purpose of this paper is to describe the Bring BG Down! study design and rationale, and participant characteristics at the start of the study.",2022,Caregiver participants and their adolescents with T1D were randomized to either the Bring BG,"['Caregiver participants and their adolescents with T1D', 'mothers of adolescents with T1D. Exploratory', 'caregivers of adolescents with type 1 diabetes']","['BG', 'FOH', 'Blood Glucose Down']","['generalized anxiety symptoms or symptoms of obsessive-compulsive disorder', 'fear of hypoglycemia']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.038903,Caregiver participants and their adolescents with T1D were randomized to either the Bring BG,"[{'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': ""O'Donnell"", 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States of America. Electronic address: holly.odonnell@cuanschutz.edu.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vigers', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States of America. Electronic address: timothy.vigers@cuanschutz.edu.'}, {'ForeName': 'Suzanne Bennett', 'Initials': 'SB', 'LastName': 'Johnson', 'Affiliation': 'Florida State University College of Medicine, Department of Behavioral Sciences and Social Medicine, 1115 W. Call Street, Tallahassee, FL 32306, United States of America. Electronic address: suzanne.johnson@med.fsu.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States of America. Electronic address: laura.pyle@cuanschutz.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gonder-Fredrick', 'Affiliation': 'Department of Psychiatry and Neurobehavioral Science, University of Virginia School of Medicine, PO Box 800623, Charlottesville, VA 29908, United States of America. Electronic address: lag3g@hscmail.mcc.virginia.edu.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Hendrieckx', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia; The Australian Centre for Behavioural Research in Diabetes, Melbourne, Victoria, Australia. Electronic address: chendrieckx@acbrd.org.au.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Driscoll', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States of America; Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, and University of Florida Diabetes Institute, 1225 Center Dr., Gainesville, FL 32610, United States of America. Electronic address: k.driscoll@phhp.ufl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106792']
1123,35589024,Study design exploring Qigong and Tai Chi Easy (QTC) on cardiometabolic risk factors.,"BACKGROUND


Cardiovascular disease is the leading cause of death in the United States paralleled with several cardiometabolic risk factors that are on the rise such as obesity, hypertension, and diabetes. Many of these cardiometabolic risk factors are preventable by lifestyle changes in physical activity and dietary patterns. Qigong and Tai Chi Easy (QTC) exercises are considered meditative movement practices that have been shown to reduce cardiometabolic risk factors such as psychosocial stress, poor sleep quality and weight gain and is particularly suitable for older adults. Heart rate variability (HRV) is a common factor known to be related to reduction of these risks and may be enhanced using HRV biofeedback to specifically optimize effects of QTC.
METHODS


The protocol presented describes a two-group parallel randomized controlled trial testing effects of QTC vs QTC plus HRV biofeedback ""priming"" on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional regulation, eating behaviors, and cognitive performance). We will enroll 50 adults aged 55-85 years old to participate in an 8-week intervention. Self-reported body measurements, psychosocial and behavioral questionnaires, and cognitive performance assessments will be conducted before and after the intervention.
CONCLUSIONS


Findings from this study are expected to assess effects of QTC and elucidate the potential role of HRV in QTC relative to cardiometabolic risk factors and sequelae. Implications for how HRV may play a central role and be optimized in a meditative movement practice are discussed.",2022,"Self-reported body measurements, psychosocial and behavioral questionnaires, and cognitive performance assessments will be conducted before and after the intervention.
","['older adults', '50 adults aged 55-85\u202fyears old to participate in an 8-week intervention']","['QTC vs QTC plus HRV biofeedback ""priming', 'Qigong and Tai Chi Easy (QTC) exercises', 'Qigong and Tai Chi Easy (QTC']","['Heart rate variability (HRV', 'Self-reported body measurements, psychosocial and behavioral questionnaires, and cognitive performance assessments', 'HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional regulation, eating behaviors, and cognitive performance', 'cardiometabolic risk factors']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0203910', 'cui_str': 'Body measurement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",50.0,0.0515965,"Self-reported body measurements, psychosocial and behavioral questionnaires, and cognitive performance assessments will be conducted before and after the intervention.
","[{'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Rameshkumar', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Larkey', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ 85004, USA; Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Alperin', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Primus', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'James', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ 85004, USA; Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ 85004, USA. Electronic address: Dara.James@asu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106793']
1124,35588964,Treatment effects on event-related EEG potentials and oscillations in Alzheimer's disease.,"Alzheimer's disease dementia (ADD) is the most diffuse neurodegenerative disorder belonging to mild cognitive impairment (MCI) and dementia in old persons. This disease is provoked by an abnormal accumulation of amyloid-beta and tauopathy proteins in the brain. Very recently, the first disease-modifying drug has been licensed with reserve (i.e., Aducanumab). Therefore, there is a need to identify and use biomarkers probing the neurophysiological underpinnings of human cognitive functions to test the clinical efficacy of that drug. In this regard, event-related electroencephalographic potentials (ERPs) and oscillations (EROs) are promising candidates. Here, an Expert Panel from the Electrophysiology Professional Interest Area of the Alzheimer's Association and Global Brain Consortium reviewed the field literature on the effects of the most used symptomatic drug against ADD (i.e., Acetylcholinesterase inhibitors) on ERPs and EROs in ADD patients with MCI and dementia at the group level. The most convincing results were found in ADD patients. In those patients, Acetylcholinesterase inhibitors partially normalized ERP P300 peak latency and amplitude in oddball paradigms using visual stimuli. In these same paradigms, those drugs partially normalize ERO phase-locking at the theta band (4-7 Hz) and spectral coherence between electrode pairs at the gamma (around 40 Hz) band. These results are of great interest and may motivate multicentric, double-blind, randomized, and placebo-controlled clinical trials in MCI and ADD patients for final cross-validation.",2022,"In those patients, Acetylcholinesterase inhibitors partially normalized ERP P300 peak latency and amplitude in oddball paradigms using visual stimuli.","[""Alzheimer's disease dementia (ADD"", ""Alzheimer's disease""]",['placebo'],"['electroencephalographic potentials (ERPs) and oscillations (EROs', 'normalized ERP P300 peak latency and amplitude in oddball paradigms using visual stimuli']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015214', 'cui_str': 'Evoked potential'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",,0.21741,"In those patients, Acetylcholinesterase inhibitors partially normalized ERP P300 peak latency and amplitude in oddball paradigms using visual stimuli.","[{'ForeName': 'Görsev', 'Initials': 'G', 'LastName': 'Yener', 'Affiliation': 'Izmir University of Economics, Faculty of Medicine, Izmir, Turkey; Izmir Biomedicine and Genome Center, Izmir, Turkey; Dokuz Eylül University, Brain Dynamics Multidisciplinary Research Center, Izmir, Turkey. Electronic address: gorsev.yener@ieu.edu.tr.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Hünerli-Gündüz', 'Affiliation': 'Dokuz Eylül University, Institute of Health Sciences, Department of Neurosciences, Izmir, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Yıldırım', 'Affiliation': 'Istanbul Medipol University, Vocational School, Program of Electroneurophysiology, Istanbul, Turkey; Istanbul Medipol University, Graduate School of Health Sciences, Department of Neuroscience, Istanbul, Turkey; Istanbul Medipol University, REMER, Clinical Electrophysiology, Neuroimaging and Neuromodulation Lab., Istanbul, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Aktürk', 'Affiliation': 'Istanbul Medipol University, Vocational School, Program of Electroneurophysiology, Istanbul, Turkey; Istanbul Medipol University, Graduate School of Health Sciences, Department of Neuroscience, Istanbul, Turkey; Istanbul Medipol University, REMER, Clinical Electrophysiology, Neuroimaging and Neuromodulation Lab., Istanbul, Turkey; Maastricht University, Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht, Netherlands.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Başar-Eroğlu', 'Affiliation': 'Izmir University of Economics, Faculty of Arts and Sciences, Department of Psychology, Turkey.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonanni', 'Affiliation': ""University G. d'Annunzio of Chieti-Pescara, Department of Neuroscience, Imaging and Clinical Sciences, Chieti, Italy.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Del Percio', 'Affiliation': 'Sapienza University of Rome, Department of Physiology and Pharmacology ""V. Erspamer"", Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Farina', 'Affiliation': 'Trinity College Dublin, Trinity College Institute of Neuroscience, Dublin, Ireland.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Ferri', 'Affiliation': 'Oasi Research Institute - IRCCS, Department of Neurology I.C., Troina, Italy.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Güntekin', 'Affiliation': 'Istanbul Medipol University, REMER, Clinical Electrophysiology, Neuroimaging and Neuromodulation Lab., Istanbul, Turkey; Istanbul Medipol University, School of Medicine, Department of Biophysics, Istanbul, Turkey.'}, {'ForeName': 'Mihály', 'Initials': 'M', 'LastName': 'Hajós', 'Affiliation': 'Cognito Therapeutics, Cambridge, MA, USA; Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Ibáñez', 'Affiliation': 'Latin American Brain Health Institute (BrainLat), Universidad Adolfo Ibáñez, Santiago de Chile, Chile; Cognitive Neuroscience Center (CNC), Universidad de San Andrés, Buenos Aires, Argentina; National Scientific and Technical Research Council (CONICET), Buenos Aires, Argentina; Global Brain Health Institute, University of California San Francisco (UCSF), USA; Trinity College Dublin (TCD), Ireland.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'University of Kentucky, College of Medicine, Department of Behavioral Science, Lexington, KY, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Lizio', 'Affiliation': 'IRCCS Synlab SDN, Napoli.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Lopez', 'Affiliation': 'University of Bari Aldo Moro, Department of Emergency and Organ Transplantation, Nephrology, Dialysis and Transplantation Unit, Bari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Noce', 'Affiliation': 'IRCCS Synlab SDN, Napoli.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Parra', 'Affiliation': 'University of Strathclyde, School of Psychological Sciences and Health, Glasgow, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Randall', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, USA.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Stocchi', 'Affiliation': 'Institute for Research and Medical Care, IRCCS San Raffaele Rome, Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Babiloni', 'Affiliation': 'Sapienza University of Rome, Department of Physiology and Pharmacology ""V. Erspamer"", Rome, Italy; San Raffaele of Cassino, Cassino, Italy.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2022.05.008']
1125,35592074,A Multilevel Physical Activity Intervention Among Chinese Rural Older Adults (Stay Active While Aging): A Study Protocol for a Clustered Randomized Controlled Trial.,"Background


Although a large number of studies have confirmed the benefits of physical activity (PA) in preventing age-related diseases and disabilities, a growing number of older people spent more time in sedentary behavior as opposed to PA. To reverse the alarming trend, numerous studies have corroborated the effectiveness of PA interventions in improving PA among older adults. However, such research is scarce in rural China, where a majority of older adults do not meet the PA recommendation. The Stay Active While Aging (SAWA) aimed to conduct an intervention to improve the PA level among older adults in rural China.
Methods


The SAWA is designed as a single-blind, clustered randomized controlled trial carried out in rural Sichuan, China with an 8-week intervention and a 24-month follow-up. The intervention group will receive a multilevel intervention (individual, interpersonal, and community levels), while the control group will not. The primary outcome is the PA level. Secondary outcome measures include sedentary behavior level, self-efficacy, self-regulation, cognitive function, night-time sleep quality, and anthropometry. The difference-in-differences (DID) will be performed to investigate the between-group differences, adjusted for baseline data and covariates.
Discussion


The SAWA trial will provide a multilevel intervention based on the socio-ecologic model among older adults in rural China. We target the PA level and health status changes while also focus on the maintenance of such intervention during 24 months. If the SAWA produces positive results, it will be possible to recommend similar strategies to be implemented in other Chinese older adults and beyond.
Trial registration


ChiCTR2100045653 (https://www.chictr.org.cn/index.aspx).",2022,"Secondary outcome measures include sedentary behavior level, self-efficacy, self-regulation, cognitive function, night-time sleep quality, and anthropometry.","['older adults', 'older adults in rural China', 'Chinese older adults', 'rural Sichuan, China with an 8-week intervention and a 24-month follow-up', 'Chinese Rural Older Adults']","['Multilevel Physical Activity Intervention', 'multilevel intervention (individual, interpersonal, and community levels']","['Stay Active While Aging', 'PA level', 'Stay Active While Aging (SAWA', 'sedentary behavior level, self-efficacy, self-regulation, cognitive function, night-time sleep quality, and anthropometry']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",,0.0839528,"Secondary outcome measures include sedentary behavior level, self-efficacy, self-regulation, cognitive function, night-time sleep quality, and anthropometry.","[{'ForeName': 'Nanyan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Health Behavior and Social Medicine, West China School Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Health Behavior and Social Medicine, West China School Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Deng', 'Affiliation': 'Department of Health Behavior and Social Medicine, West China School Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Julinling', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Health Behavior and Social Medicine, West China School Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Health Behavior and Social Medicine, West China School Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.'}]",Frontiers in public health,['10.3389/fpubh.2022.760457']
1126,35593677,The effect of repeated remote ischemic postconditioning after an ischemic stroke (REPOST): A randomized controlled trial.,"BACKGROUND AND AIMS


A potential strategy to treat ischemic stroke may be the application of repeated remote ischemic postconditioning (rIPostC). This consists of several cycles of brief periods of limb ischemia followed by reperfusion, which can be applied by inflating a simple blood pressure cuff and subsequently could result in neuroprotection after stroke.
METHODS


Adult patients admitted with an ischemic stroke in the past 24 h were randomized 1:1 to repeated rIPostC or sham-conditioning. Repeated rIPostC was performed by inflating a blood pressure cuff around the upper arm (4 × 5 min at 200 mm Hg), which was repeated twice daily during hospitalization with a maximum of 4 days. Primary outcome was infarct size after 4 days or at discharge. Secondary outcomes included the modified Rankin Scale (mRS)-score after 12 weeks and the National Institutes of Health Stroke Scale (NIHSS) at discharge.
RESULTS


The trial was preliminarily stopped after we included 88 of the scheduled 180 patients (average age: 70 years, 68% male) into rIPostC (n = 40) and sham-conditioning (n = 48). Median infarct volume was 2.19 mL in rIPostC group and 5.90 mL in sham-conditioning, which was not significantly different between the two groups (median difference: 3.71; 95% CI: -0.56 to 6.09; p = 0.31). We found no significant shift in the mRS score distribution between groups. The adjusted common odds ratio was 2.09 (95% CI: 0.88-5.00). We found no significant difference in the NIHSS score between groups (median difference: 1.00; 95% CI: -0.99 to 1.40; p = 0.51).
CONCLUSION


This study found no significant improvement in infarct size or clinical outcome in patients with an acute ischemic stroke who were treated with repeated remote ischemic postconditioning. However, due to a lower-than-expected inclusion rate, no definitive conclusions about the effectiveness of rIPostC can be drawn.",2022,We found no significant difference in the NIHSS-score between groups (median difference: 1.00; 95%CI: -0.99 to 1.40; P=0.51).,"['patients with an acute ischemic stroke who were treated with repeated remote ischemic postconditioning', '88 of the scheduled 180 patients (average age: 70 years, 68% male) into rIPostC (n=40) and sham-conditioning (n=48', 'Adult patients admitted with an ischemic stroke in the past 24 hours']","['remote ischemic postconditioning', 'rIPostC or sham-conditioning']","['infarct size after 4 days or at discharge', 'infarct size or clinical outcome', 'modified Rankin Scale (mRS)-score after 12 weeks and the National Institutes of Health Stroke Scale (NIHSS) at discharge', 'NIHSS-score', 'Median infarct volume', 'mRS-score distribution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",,0.567317,We found no significant difference in the NIHSS-score between groups (median difference: 1.00; 95%CI: -0.99 to 1.40; P=0.51).,"[{'ForeName': 'Thijs Rj', 'Initials': 'TR', 'LastName': 'Landman', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Schoon', 'Affiliation': 'Department of Geriatric Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Michiel C', 'Initials': 'MC', 'LastName': 'Warlé', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Frederick Ja', 'Initials': 'FJ', 'LastName': 'Meijer', 'Affiliation': 'Department of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Frank-Erik De', 'Initials': 'FE', 'LastName': 'Leeuw', 'Affiliation': 'Donders Center for Medical Neuroscience, Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Dick Hj', 'Initials': 'DH', 'LastName': 'Thijssen', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/17474930221104710']
1127,35594970,Online treatment of adolescents with comorbid anxiety and depression: A randomized controlled trial.,"OBJECTIVE


Adolescents experiencing both anxiety and mood disorders show greater life impairment than those with either disorder alone. The aim of this study was to evaluate the efficacy of an online cognitive behavior therapy (CBT) program for these comorbid youth.
METHODS


Ninety-one adolescents aged 12 to 17 years (M = 14.29, S.D. = 1.62; 66% female) participated if they met DSM-5 criteria for both an anxiety and depressive disorder. Diagnoses were assessed by structured interview and participants also completed measures of symptoms, negative thoughts, and life interference. Participants were randomly allocated to either active treatment (n = 45) or wait (n = 46). Treatment comprised access to an 8-module, online program and was supported by 8, 30-minute telephone sessions with a therapist and the youth, of which the caregiver participated in four.
RESULTS


Treated participants showed significantly greater reduction than waiting participants on the primary outcome: total number of disorders and were more likely to remit from all anxiety and mood disorders (43.8% vs 20.9%). Secondary outcomes covering symptoms of anxiety and depression showed similar group by time differences, but there was no significant group by time interaction on life interference.
CONCLUSIONS


This brief, easily accessible, online intervention that requires relatively low levels of therapist time showed promising impact for a very impaired population.
REGISTRATION


This trial was registered on the ANZ clinical trials registry-ACTRN12616000139471.",2022,"RESULTS


Treated participants showed significantly greater reduction than waiting participants on the primary outcome: total number of disorders and were more likely to remit from all anxiety and mood disorders (43.8% vs 20.9%).","['Adolescents experiencing both anxiety and mood disorders', 'adolescents with comorbid anxiety and depression', 'Ninety-one adolescents aged 12 to 17\u202fyears (M\u202f=\u202f14.29, S.D.\u202f=\u202f1.62; 66% female) participated if they met DSM-5 criteria for both an anxiety and depressive disorder']","['active treatment', 'online cognitive behavior therapy (CBT) program']","['symptoms of anxiety and depression', 'symptoms, negative thoughts, and life interference', 'anxiety and mood disorders', 'time interaction on life interference', 'total number of disorders']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",91.0,0.0997766,"RESULTS


Treated participants showed significantly greater reduction than waiting participants on the primary outcome: total number of disorders and were more likely to remit from all anxiety and mood disorders (43.8% vs 20.9%).","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Schniering', 'Affiliation': 'Centre for Emotional Health, School of Psychological Sciences, Macquarie University, Sydney, NSW 2109. Australia. Electronic address: carolyn.schniering@mq.edu.au.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Einstein', 'Affiliation': 'School of Psychological Sciences, Sydney, NSW 2109. Australia. Electronic address: danielle.einstein@mq.edu.au.'}, {'ForeName': 'Jessica J L', 'Initials': 'JJL', 'LastName': 'Kirkman', 'Affiliation': 'School of Psychological Sciences, Sydney, NSW 2109. Australia. Electronic address: jess.kirkman@mq.edu.au.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, School of Psychological Sciences, Macquarie University, Sydney, NSW 2109. Australia. Electronic address: ron.rapee@mq.edu.au.'}]",Journal of affective disorders,['10.1016/j.jad.2022.05.072']
1128,35594968,Effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on depression and neural structural connectivity.,"BACKGROUND


Hypertension-related illnesses are a leading cause of disability and death in the United States, where hypertension prevalence in adults is 46%, with only half of those afflicted having it under control. Due to the significant challenges in long-term efficacy and adverse effects associated with pharmacological interventions, there is an eminent need for complimentary approaches for treating hypertension. Although initial studies of the Mindfulness-Based Blood Pressure Reduction program (MB-BP) indicate that this novel 8-week intervention is effective at inducing lasting decreases in blood pressure, the neural correlates are unknown.
METHODS


The objectives of this study were to identify structural neural correlates of MB-BP using diffusion tensor magnetic resonance imaging (DTI) and assess potential correlations with key clinical outcomes.
RESULTS


In a subset of participants (14 MB-BP, 22 controls) from a larger stage IIa randomized controlled trial, MB-BP participants exhibited increased interoception and decreased depressive symptoms compared to controls. Analyses of DTI data revealed significant group differences in multiple white matter neural tracts associated with the limbic system and/or blood pressure. Specific changes in neural structural connectivity were significantly associated with measures of interoception and depression.
LIMITATIONS


Limitations include small sample size (leading to insufficient power in the analysis of blood pressure) and the study duration (3 months). The main MRI limitation is suboptimal resolution in areas of extensive neural tract crossings.
CONCLUSIONS


It is concluded that MB-BP induces alterations in brain structural connectivity which could mediate beneficial changes in depression and interoceptive awareness in individuals with hypertension.",2022,Analyses of DTI data revealed significant group differences in multiple white matter neural tracts associated with the limbic system and/or blood pressure.,['individuals with hypertension'],"['diffusion tensor magnetic resonance imaging (DTI', 'MB-BP', 'Mindfulness-Based Blood Pressure Reduction program (MB-BP', 'Mindfulness-Based Blood Pressure Reduction (MB-BP) program']","['blood pressure', 'depression and neural structural connectivity', 'depressive symptoms', 'limbic system and/or blood pressure', 'neural structural connectivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0023715', 'cui_str': 'Limbic system structure'}]",,0.178583,Analyses of DTI data revealed significant group differences in multiple white matter neural tracts associated with the limbic system and/or blood pressure.,"[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Polcari', 'Affiliation': 'Dept. of Biology and Biotechnology, Worcester Polytechnic Institute, Worcester, MA, United States of America. Electronic address: jjpolcari@wpi.edu.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Cali', 'Affiliation': 'Dept. of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States of America. Electronic address: rcali@mgh.harvard.edu.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Nephew', 'Affiliation': 'Dept. of Biology and Biotechnology, Worcester Polytechnic Institute, Worcester, MA, United States of America. Electronic address: bnephew@wpi.edu.'}, {'ForeName': 'Senbao', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Dept. of Computer Science, Worcester Polytechnic Institute, Worcester, MA, United States of America. Electronic address: slu3@wpi.edu.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Rashkovskii', 'Affiliation': 'Dept. of Biology and Biotechnology, Worcester Polytechnic Institute, Worcester, MA, United States of America. Electronic address: mrashkovskii@wpi.edu.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Dept. of Biology and Biotechnology, Worcester Polytechnic Institute, Worcester, MA, United States of America. Electronic address: jiarongw@middlebury.edu.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Saadeh', 'Affiliation': 'Dept. of Behavioral and Social Sciences, Brown University, Providence, RI, United States of America. Electronic address: frances_saadeh@brown.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Loucks', 'Affiliation': 'Dept. of Behavioral and Social Sciences, Brown University, Providence, RI, United States of America. Electronic address: eric_loucks@brown.edu.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'Dept. of Biology and Biotechnology, Worcester Polytechnic Institute, Worcester, MA, United States of America. Electronic address: jaking@wpi.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2022.05.059']
1129,35594928,Perceived effectiveness of added-sugar warning label designs for U.S. restaurant menus: An online randomized controlled trial.,"Added-sugar consumption in the U.S. exceeds recommended limits. Policymakers are considering requiring restaurants to use menu warning labels to indicate items high in added sugar. We sought to determine whether icon-only and icon-plus-text added-sugar menu labels were (1) perceived as more effective at potentially reducing consumption of items high in added sugar and (2) increased knowledge of menu items' added-sugar content relative to control labels, and if effects differed by label design. A national sample of U.S. adults (n = 1327) participated in an online randomized experiment. Participants viewed menu items with either a control label, 1 of 6 icon-only labels, or 1 of 18 icon-plus-text labels with 3 text variations. For their assigned label, participants provided ratings of perceived message effectiveness (a validated scale of a message's potential to change behavior). Participants were also asked to classify menu items by their added-sugar content. The icon-only and icon-plus-text labels were perceived as more effective than the control label (means: 3.7 and 3.7 vs. 3.1, respectively, on a 5-point scale; p < 0.001). The icon-only and icon-plus-text groups each correctly classified 71% of menu items by added-sugar content vs. 56% in the control group (p < 0.001). All icons and text variations were perceived as similarly effective. In conclusion, relative to a control label, icon-only and icon-plus-text added-sugar menu labels were perceived as effective and helped consumers identify items high in added sugar. Menu warning labels may be a promising strategy for reducing added-sugar consumption from restaurants, but research on behavioral effects in real-world settings is needed. Clinical Trials Identifier:NCT04637412.",2022,The icon-only and icon-plus-text labels were perceived as more effective than the control label (means:,"['A national sample of U.S. adults (n\u202f=\u202f1327', 'U.S. restaurant menus']",['icon-only and icon-plus-text added-sugar menu labels'],[],"[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}]","[{'cui': 'C0243020', 'cui_str': 'Immunoconjugate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",[],1327.0,0.0539493,The icon-only and icon-plus-text labels were perceived as more effective than the control label (means:,"[{'ForeName': 'Desiree M', 'Initials': 'DM', 'LastName': 'Sigala', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California Davis, 1 Shields Ave, Davis, CA 95616, USA. Electronic address: dmsigala@ucdavis.edu.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health; Lineberger Comprehensive Cancer Center; and Carolina Population Center; University of North Carolina Chapel Hill, 170 Rosenau Hall, CB #7400, 135 Dauer Drive, Chapel Hill, NC 27599, USA. Electronic address: mghall@unc.edu.'}, {'ForeName': 'Aviva A', 'Initials': 'AA', 'LastName': 'Musicus', 'Affiliation': 'Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, USA. Electronic address: aam231@mail.harvard.edu.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Roberto', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine at the University of Pennsylvania, 3400 Civic Center Blvd, Building 421, Philadelphia, PA 19104, USA. Electronic address: croberto@pennmedicine.upenn.edu.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Solar', 'Affiliation': 'Human Development and Family Studies Program, Department of Human Ecology, University of California Davis, 1 Shields Ave, Davis, CA 95616, USA. Electronic address: sesolar@ucdavis.edu.'}, {'ForeName': 'Sili', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Department of Statistics, University of California Davis, 1 Shields Ave, Davis, CA 95616, USA. Electronic address: slfan@ucdavis.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sorscher', 'Affiliation': 'The Center for Science in the Public Interest, 1220 L St. N.W., Suite 300, Washington, D.C. 20005, USA. Electronic address: ssorscher@cspinet.org.'}, {'ForeName': 'DeAnna', 'Initials': 'D', 'LastName': 'Nara', 'Affiliation': 'The Center for Science in the Public Interest, 1220 L St. N.W., Suite 300, Washington, D.C. 20005, USA. Electronic address: dnara@cspinet.org.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Falbe', 'Affiliation': 'Human Development and Family Studies Program, Department of Human Ecology, University of California Davis, 1 Shields Ave, Davis, CA 95616, USA. Electronic address: jfalbe@ucdavis.edu.'}]",Preventive medicine,['10.1016/j.ypmed.2022.107090']
1130,35596963,Deploying a telemedicine collaborative care intervention for posttraumatic stress disorder in the U.S. Department of Veterans Affairs: A stepped wedge evaluation of an adaptive implementation strategy.,"OBJECTIVE


To address barriers to trauma-focused psychotherapy for veterans with posttraumatic stress disorder (PTSD), we compared two implementation strategies to promote the deployment of telemedicine collaborative care.
METHOD


We conducted a Hybrid Type III Effectiveness Implementation trial at six VA medical centers and their 12 affiliated Community Based Outpatient Clinics. The trial used a stepped wedge design and an adaptive implementation strategy that started with standard implementation, followed by enhanced implementation for VA medical centers that did not achieve the performance benchmark. Implementation outcomes for the 544 veterans sampled from the larger population targeted by the intervention were assessed from chart review (care management enrollment and receipt of trauma-focused psychotherapy) and telephone survey (perceived access and PTSD symptoms) after each implementation phase. The primary outcome was enrollment in care management.
RESULTS


There was no significant difference between standard implementation and enhanced implementation on any of the implementation outcomes. 41.6% of sampled veterans had a care manager encounter, but only 6.0% engaged in trauma-focused psychotherapy.
CONCLUSIONS


While telemedicine collaborative care was shown to be effective at engaging veterans in trauma-focused psychotherapy in a randomized controlled trial, neither standard nor enhanced implementation strategies were sufficient to support successful deployment into routine care.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02737098.",2022,"While telemedicine collaborative care was shown to be effective at engaging veterans in trauma-focused psychotherapy in a randomized controlled trial, neither standard nor enhanced implementation strategies were sufficient to support successful deployment into routine care.
","['six VA medical centers and their 12 affiliated Community Based Outpatient Clinics', '544 veterans sampled from the larger population targeted by the intervention were assessed from chart review (care management enrollment and receipt of trauma-focused psychotherapy) and telephone survey (perceived access and PTSD symptoms) after each implementation phase', 'veterans with posttraumatic stress disorder (PTSD', 'posttraumatic stress disorder in the U.S. Department of Veterans Affairs']","['telemedicine collaborative care intervention', 'trauma-focused psychotherapy']",['enrollment in care management'],"[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0039309', 'cui_str': 'Target Population'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",12.0,0.0397781,"While telemedicine collaborative care was shown to be effective at engaging veterans in trauma-focused psychotherapy in a randomized controlled trial, neither standard nor enhanced implementation strategies were sufficient to support successful deployment into routine care.
","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Fortney', 'Affiliation': 'VA HSR&D Center for Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, WA, United States of America; Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States of America. Electronic address: fortneyj@uw.edu.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': 'VA HSR&D Center for Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, WA, United States of America.'}, {'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Reisinger', 'Affiliation': 'VA HSR&D Center for Access & Delivery Research and Evaluation, Iowa City VA Health Care System, IA, United States of America; Department of Internal Medicine, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Moeckli', 'Affiliation': 'VA HSR&D Center for Access & Delivery Research and Evaluation, Iowa City VA Health Care System, IA, United States of America.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': ''}, {'ForeName': 'Edwin S', 'Initials': 'ES', 'LastName': 'Wong', 'Affiliation': 'VA HSR&D Center for Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, WA, United States of America; Department of Health and Systems and Population Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA HSR&D Center for Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, WA, United States of America.'}, {'ForeName': 'Valentina V', 'Initials': 'VV', 'LastName': 'Petrova', 'Affiliation': 'VA HSR&D Center for Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, WA, United States of America.'}, {'ForeName': 'George G', 'Initials': 'GG', 'LastName': 'Sayre', 'Affiliation': 'VA HSR&D Center for Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, WA, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Pyne', 'Affiliation': 'VA HSR&D Center for Mental Health and Outcomes Research, Central Arkansas Veterans Healthcare System, Little Rock, AR, United States of America; Department of Psychiatry, University of Arkansas for Medical Sciences, Little Rock, AR, United States of America.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Grubaugh', 'Affiliation': 'VA HSR&D Charleston Health Equity and Rural Outreach Innovation Center, Charleston, SC, United States of America; Department of Psychiatry, Medical University of South Carolina, Charleston, SC, United States of America.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Simsek-Duran', 'Affiliation': 'Iowa City VA Health Care System, IA, United States of America; Department of Psychiatry, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Grubbs', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States of America; Department of Psychiatry, University of California-San Diego, San Diego, CA, United States of America.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Morland', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States of America; Department of Psychiatry, University of California-San Diego, San Diego, CA, United States of America.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Felker', 'Affiliation': 'VA HSR&D Center for Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, WA, United States of America; Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Paula P', 'Initials': 'PP', 'LastName': 'Schnurr', 'Affiliation': 'National Center for PTSD, VA Medical Center, White River Junction, VT, United States of America; Geisel School of Medicine at Dartmouth, Hanover, NH, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2022.03.009']
1131,35587504,Transcranial direct current stimulation does not improve clinical and neurophysiological outcomes in panic disorder: A randomized sham-controlled trial.,"AIM


Emerging evidence suggests that transcranial direct current stimulation (tDCS) has anxiolytic effects and may enhance emotional processing of threat and reduce threat-related attentional bias. Panic disorder (PD) is considered to be a fear network disorder along with prefrontal activity alterations. We aim to assess the effect of tDCS on clinical and physiological parameters in PD for the first time.
METHODS


In this triple-blind randomized sham-controlled pilot study, 30 individuals with PD were allocated into active and sham groups to receive 10 sessions of tDCS targeting the dorsolateral prefrontal cortex bilaterally at 2 mA for 20-min duration over 2 weeks. The clinical severity, threat-related attentional bias, interoceptive accuracy, and emotional recognition were assessed before, immediately after, and 1 month after tDCS.
RESULTS


Active tDCS, in comparison to sham, did not elicit more favorable clinical and neuropsychological/physiological outcomes in PD.
CONCLUSION


The present study provides the first clinical and neurobehavioral results of prefrontal tDCS in PD and indicates that prefrontal tDCS was not superior to sham in PD.",2022,"RESULTS


Active tDCS, in comparison to sham, did not elicit more favorable clinical and neuropsychological/physiological outcomes in PD.
","['thirty individuals with PD', 'Panic Disorder', 'Panic disorder (PD']","['Transcranial Direct Current Stimulation', 'tDCS', 'transcranial Direct Current Stimulation (tDCS']","['clinical severity, threat-related attentional bias, interoceptive accuracy, and emotional recognition']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",30.0,0.243979,"RESULTS


Active tDCS, in comparison to sham, did not elicit more favorable clinical and neuropsychological/physiological outcomes in PD.
","[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Aksu', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Muğla Sıtkı Koçman University, Muğla, Turkey.'}, {'ForeName': 'Ahmet Zihni', 'Initials': 'AZ', 'LastName': 'Soyata', 'Affiliation': 'Department of Psychiatry, Ergani State Hospital, Diyarbakır, Turkey.'}, {'ForeName': 'Zhala', 'Initials': 'Z', 'LastName': 'Mursalova', 'Affiliation': 'Department of Psychiatry, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Gaye', 'Initials': 'G', 'LastName': 'Eskicioğlu', 'Affiliation': 'Department of Psychology, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Raşit', 'Initials': 'R', 'LastName': 'Tükel', 'Affiliation': 'Department of Psychiatry, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13378']
1132,35587457,Should we stop prescribing IM progesterone to women with a history of preterm labor?,"YES, we should stop the routine prescribing of IM progesterone to prevent preterm delivery. A 2003 randomized controlled trial (RCT) found that weekly intramuscular (IM) 17 hydroxyprogesterone (17-OHP) for women with a singleton pregnancy and a history of spontaneous preterm delivery decreased the preterm delivery rate by 34% (strength of recommendation [SOR]: B, single RCT). However, the follow-up 2020 PROLONG RCT did not find that 17-OHP prevents preterm birth or improves neonatal outcomes. This held true for subgroup analyses (SOR: B, single larger RCT). (Notably, though, the PROLONG study had very few Black participants when compared with the 2003 study.)The US Food and Drug Administration (FDA) has recommended withdrawing 17-OHP from the market. The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have released statements supporting shared decision-making with women regarding the prescribing of 17-OHP for preterm delivery prevention (SOR: C, expert opinion).",2022,"This held true for subgroup analyses (SOR: B, single larger RCT).","['American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM', 'women with a singleton pregnancy and a history of spontaneous preterm delivery decreased the preterm delivery rate by 34% (strength of recommendation [SOR]: B, single RCT']","['weekly intramuscular (IM) 17 hydroxyprogesterone (17-OHP', '17-OHP', 'IM progesterone']",['preterm birth or improves neonatal outcomes'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0586884', 'cui_str': 'Obstetrician and gynecologist'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C0202075', 'cui_str': '17 Hydroxyprogesterone measurement'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.184915,"This held true for subgroup analyses (SOR: B, single larger RCT).","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Dresang', 'Affiliation': 'University of Wisconsin, Department of Family Medicine and Community Health, Madison.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Vellardita', 'Affiliation': 'Ebling Library, University of Wisconsin School of Medicine and Public Health, Madison.'}]",The Journal of family practice,['10.12788/jfp.0334']
1133,35587452,Does adjunctive oxytocin infusion during balloon cervical ripening improve labor induction?,"Evidence-Based Answer: Yes. Compared to the use of a transcervical balloon alone, combined cervical ripening with a balloon catheter and oxytocin shortens the time to overall delivery by 3 hours and the time to vaginal delivery by 4 hours, without altering the rate of cesarean section (strength of recommendation [SOR]: A, network meta-analysis). The effect is more pronounced in nulliparous patients (SOR: A, meta-analysis).When combined therapy is used, 6 hours of balloon time may result in faster delivery than 12 hours (SOR: B, single randomized controlled trial [RCT]). Fixed-dose oxytocin and titrated oxytocin appear to have similar effect when combined with a cervical ripening balloon (SOR: C, underpowered RCT).",2022,"Fixed-dose oxytocin and titrated oxytocin appear to have similar effect when combined with a cervical ripening balloon (SOR: C, underpowered RCT).",['nulliparous patients (SOR'],"['oxytocin and titrated oxytocin', 'oxytocin', 'transcervical balloon alone, combined cervical ripening with a balloon catheter and oxytocin']",[],"[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}]",[],,0.0759535,"Fixed-dose oxytocin and titrated oxytocin appear to have similar effect when combined with a cervical ripening balloon (SOR: C, underpowered RCT).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dubay', 'Affiliation': 'Valley Family Medicine, Renton, WA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rentschler', 'Affiliation': 'Valley Family Medicine, Renton, WA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Jolly', 'Affiliation': 'Valley Family Medicine, Renton, WA.'}, {'ForeName': 'Jon O', 'Initials': 'JO', 'LastName': 'Neher', 'Affiliation': 'Valley Family Medicine, Renton, WA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Safranek', 'Affiliation': 'Librarian Emeritus, University of Washington, Seattle.'}]",The Journal of family practice,['10.12788/jfp.0353']
1134,35588201,Talking Circle For Young Adults (TC4YA) intervention: a culturally safe research exemplar.,"Background : As a result of the intergenerational trauma impact and experience, Native Americans continue to exhibit trauma-related issues such as high rates of substance use. After leaving high school, the pressures and stress of continuing an education, finding work/employment, and the responsibilities related to family and tribal community obligations result in the Native American young adult being more vulnerable to substance use. Objective : The purpose of this paper is to report findings of the Talking Circle intervention impact on the outcome variables of Native-Reliance, substance use, stress, and behavioural health, depression, and cumulative trauma. Methods : Native-Reliance was the theoretical underpinning for the study, demonstrating culturally safe research. A pre-test/post-test one-group design was utilised to examine how the Talking Circle intervention influenced the outcome variables. In total, 75 Native American participants, ages 18-24, participated in the Talking Circle intervention sessions. Baseline pre-intervention measures were completed and were repeated at 6-month post-intervention. Results : At 6-month post-intervention, Native-Reliance significantly revealed an increase of 40.55 ( t  = 22.13,  p  < .001), sources of stress (SS) revealed a significant decline of 3.68 ( t  = -18.39,  p  < .001), behavioural health issues (BH) showed a significant decline of 3.63 ( t  = -15.36,  p  < .001), substance-related issues (SR) showed a significant decline of 3.57 ( t  = -15.24,  p  < .001), depression (PHQ-9) showed a significant decline of 4.85 ( t  = -17.02,  p  < .001), and cumulative trauma revealed a significant decline of 2.77 ( t  = -13.39,  p  < .001). Conclusions : The use of a culturally safe Talking Circle intervention evidenced a research approach that resulted in a positive impact on reducing substance use and increasing the well-being of young Native American young adults. Impact Statement:  Culturally safer intervention environments are conducive to results in outcomes that are positive and effective.",2022,"At 6-month post-intervention, Native-Reliance significantly revealed an increase of 40.55 (t = 22.13, p < .001), sources of stress (SS) revealed a significant decline of 3.68 (t= -18.39, p < .001), behavioral health issues (BH) showed a significant decline of 3.63 (t = -15.36, p < .001), substance related issues (SR) showed a significant decline of 3.57 (t = -15.24, p < .001), depression (PHQ-9) showed a significant decline of 4.85 (t = -17.02, p < .001), and cumulative trauma revealed a significant decline of 2.77 (t= -13.39, p < .001).
","['75 Native American participants, ages 18-24 participated in the Talking Circle intervention sessions', 'young Native American young adults', 'Young Adults']",['TC4YA) Intervention'],"['cumulative trauma', 'sources of stress (SS', 'depression (PHQ-9', 'behavioral health issues (BH', 'Native-Reliance, substance use, stress, and behavioral health, depression, and cumulative trauma']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0290627', 'cui_str': 'Reliance resin cement'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",75.0,0.0544935,"At 6-month post-intervention, Native-Reliance significantly revealed an increase of 40.55 (t = 22.13, p < .001), sources of stress (SS) revealed a significant decline of 3.68 (t= -18.39, p < .001), behavioral health issues (BH) showed a significant decline of 3.63 (t = -15.36, p < .001), substance related issues (SR) showed a significant decline of 3.57 (t = -15.24, p < .001), depression (PHQ-9) showed a significant decline of 4.85 (t = -17.02, p < .001), and cumulative trauma revealed a significant decline of 2.77 (t= -13.39, p < .001).
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': 'School of Nursing, The University of Texas at Austin, 1710 Red River Street, Austin, TX, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Millender', 'Affiliation': 'College of Nursing, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Best', 'Affiliation': 'School of Nursing and Midwifery, University of Southern Queensland, Ipswich Campus, Ipswich, Queensland, Australia.'}]",Contemporary nurse,['10.1080/10376178.2022.2080087']
1135,35589854,Rituximab versus tocilizumab in rheumatoid arthritis: synovial biopsy-based biomarker analysis of the phase 4 R4RA randomized trial.,"Patients with rheumatoid arthritis (RA) receive highly targeted biologic therapies without previous knowledge of target expression levels in the diseased tissue. Approximately 40% of patients do not respond to individual biologic therapies and 5-20% are refractory to all. In a biopsy-based, precision-medicine, randomized clinical trial in RA (R4RA; n = 164), patients with low/absent synovial B cell molecular signature had a lower response to rituximab (anti-CD20 monoclonal antibody) compared with that to tocilizumab (anti-IL6R monoclonal antibody) although the exact mechanisms of response/nonresponse remain to be established. Here, in-depth histological/molecular analyses of R4RA synovial biopsies identify humoral immune response gene signatures associated with response to rituximab and tocilizumab, and a stromal/fibroblast signature in patients refractory to all medications. Post-treatment changes in synovial gene expression and cell infiltration highlighted divergent effects of rituximab and tocilizumab relating to differing response/nonresponse mechanisms. Using ten-by-tenfold nested cross-validation, we developed machine learning algorithms predictive of response to rituximab (area under the curve (AUC) = 0.74), tocilizumab (AUC = 0.68) and, notably, multidrug resistance (AUC = 0.69). This study supports the notion that disease endotypes, driven by diverse molecular pathology pathways in the diseased tissue, determine diverse clinical and treatment-response phenotypes. It also highlights the importance of integration of molecular pathology signatures into clinical algorithms to optimize the future use of existing medications and inform the development of new drugs for refractory patients.",2022,Post-treatment changes in synovial gene expression and cell infiltration highlighted divergent effects of rituximab and tocilizumab relating to differing response/nonresponse mechanisms.,"['RA (R4RA; n\u2009=\u2009164), patients with low/absent synovial B\u2009cell molecular signature had a lower response to rituximab (anti-CD20 monoclonal antibody', 'rheumatoid arthritis', 'Patients with rheumatoid arthritis (RA']","['Rituximab versus tocilizumab', 'rituximab and tocilizumab', 'tocilizumab']",[],"[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0796614', 'cui_str': 'ocaratuzumab'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}]",[],,0.107951,Post-treatment changes in synovial gene expression and cell infiltration highlighted divergent effects of rituximab and tocilizumab relating to differing response/nonresponse mechanisms.,"[{'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Rivellese', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna E A', 'Initials': 'AEA', 'LastName': 'Surace', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Katriona', 'Initials': 'K', 'LastName': 'Goldmann', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Sciacca', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Cankut', 'Initials': 'C', 'LastName': 'Çubuk', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Giorli', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'John', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Nerviani', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Liliane', 'Initials': 'L', 'LastName': 'Fossati-Jimack', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Thorborn', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Manzoor', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Prediletto', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Church', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA, USA.'}, {'ForeName': 'Briana M', 'Initials': 'BM', 'LastName': 'Hudson', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Warren', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'McKeigue', 'Affiliation': 'Usher Institute, College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Humby', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bombardieri', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Barnes', 'Affiliation': 'Centre for Translational Bioinformatics, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Myles J', 'Initials': 'MJ', 'LastName': 'Lewis', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. myles.lewis@qmul.ac.uk.'}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Pitzalis', 'Affiliation': 'Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. c.pitzalis@qmul.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature medicine,['10.1038/s41591-022-01789-0']
1136,35597066,Effıcacy of cıtalopram on stroke recurrence: A randomızed clınıcal trıal.,"Post-stroke depression is one of the main causes of cerebrovascular and cardiovascular diseases. The aim of the present study was to investigate the efficacy of citalopram on stroke recurrence. A 52-week, randomized, double-blind, studyinvolved 440 ischemic stroke patients with depression. Patients with depression who met depression criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV and V) and Hamilton Depression Rating Scale ≥ 8 (HAM-DRS) were dichotomized into patients receiving citalopram (225 patients), titrated according to clinical response, and patients with placebo (215 patients) for 52 weeks. The primary outcome measure was stroke recurrence and the secondary outcome measures were cardiovascular events and mortality. Stroke recurrence (66% vs 34%; P = 0.001) and cardiovascular events (76% vs. 24%; P = o.oo1) were significantly higher in the placebo group compared to those treated with citalopram. Multivariable analysis showed that hypertension, atrial fibrillation, and large-artery disease were significantly associated with stroke recurrence. Executive processing disorder was more associated with stroke recurrence than other neuropsychological disorders (OR, 1.74; CI95%, 1.04-2.89; P = 0.035). Survival analysis showed that treatment for depression interacted with time to reduce stroke recurrence by nearly half (39% vs. 61%; P = 0.05). The current study supports the importance of depression treatment in protecting the patients from recurrent strokes. This result warrants further studies to demonstrate the efficacy of depression treatment on stroke recurrence.",2022,"Executive processing disorder was more associated with stroke recurrence than other neuropsychological disorders (OR, 1.74; CI95%, 1.04-2.89; P = 0.035).","['Patients with depression who met depression criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV and V) and Hamilton Depression Rating Scale\xa0≥\xa08 (HAM-DRS) were dichotomized into patients receiving', '440 ischemic stroke patients with depression']","['citalopram', 'cıtalopram', 'placebo']","['Executive processing disorder', 'hypertension, atrial fibrillation, and large-artery disease', 'stroke recurrence', 'cardiovascular events and mortality', 'cardiovascular events', 'Stroke recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.213549,"Executive processing disorder was more associated with stroke recurrence than other neuropsychological disorders (OR, 1.74; CI95%, 1.04-2.89; P = 0.035).","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ece Çetin', 'Affiliation': 'Acıbadem Hospital, Neurology Department, Bursa, Turkey. Electronic address: fececetin76@gmail.com.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Kumral', 'Affiliation': 'Ege University Medical School Hospital, Neurology Department, İzmir, Turkey. Electronic address: emre.kumral@ege.edu.tr.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Saffet Gönül', 'Affiliation': 'Ege University Medical School Hospital, Neurology Department, İzmir, Turkey. Electronic address: ali.saffet.gonul@ege.edu.tr.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Nezih Özdemir', 'Affiliation': 'Ege University Medical School Hospital, Neurology Department, İzmir, Turkey. Electronic address: huseyin.nezih.ozdemir@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Orman', 'Affiliation': 'Ege University, Department of Administration and Statistics, İzmir, Turkey. Electronic address: mehmet.orman@ege.edu.tr.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2022.05.014']
1137,35597065,Treatment method selection for sleep quality due to lumbar DISC herniation: Early surgery or others?; A single center clinical trial.,"BACKGROUND/AIM


Sleep deprivation may lead to individual and social insufficiency associated with many physiological and psychological pathologies. This study is reported to investigate sleep quality and the relationship between treatment modalities of lumbar disc herniation, which is the most common cause of chronic lower back pain and sciatica.
MATERIALS AND METHODS


This present study was conducted on 249 cases with chronic lower back pain and sciatica caused by a single- level lumbar disc herniation diagnosed after lumbar MRI (Magnetic Resonance Imaging) between June 2017 and September 2019. Cases were divided into three groups according to the treatment modalities: early surgical treatment (n:80), extended conservative treatment (n:142), and medical treatment only (n:27). VAS (Visual Analog Scale) and PSQI (Pittsburgh Sleep Quality Index) data before the treatment and 6 months after the treatment were statistically analyzed.
RESULTS


It was determined that post-treatment VAS and PSQI scores were significantly reduced in all cases, regardless of the differences in treatment modalities (p < 0.05). In the early surgical treatment group, VAS score was improved by 69% and PSQI score was improved by 63.8%. These values were 28.5% and 38.6% in the extended conservative treatment. However, VAS score was increased by 27% in the patients who received only medical treatment. Statistical analysis of the treatment modalities showed that early surgical treatment was superior to the other treatment modalities (p < 0.05).
CONCLUSIONS


It was determined that early surgical treatment of lumbar disc herniation was superior to other treatment methods in terms of maintaining the sleep quality impairments associated with deterioration in sleep quality.",2022,"Statistical analysis of the treatment modalities showed that early surgical treatment was superior to the other treatment modalities (p < 0.05).
",['249 cases with chronic lower back pain and sciatica caused by a single- level lumbar disc herniation diagnosed after lumbar MRI (Magnetic Resonance Imaging) between June 2017 and September 2019'],"['surgical treatment (n:80), extended conservative treatment (n:142), and medical treatment only (n:27']","['sleep quality', 'VAS and PSQI scores', 'VAS score', 'VAS (Visual Analog Scale) and PSQI (Pittsburgh Sleep Quality Index) data', 'PSQI score']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",249.0,0.0543174,"Statistical analysis of the treatment modalities showed that early surgical treatment was superior to the other treatment modalities (p < 0.05).
","[{'ForeName': 'Ahmed Yasin', 'Initials': 'AY', 'LastName': 'Yavuz', 'Affiliation': 'Department of Neurosurgery, University of Health Sciences Turkey, Prof. Dr. Cemil Taşçıoğlu City Hospital, Turkey. Electronic address: ayasinyavuz@gmail.com.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Uysal', 'Affiliation': 'Department of Neurosurgery, University of Health Sciences Turkey, Prof. Dr. Cemil Taşçıoğlu City Hospital, Turkey. Electronic address: dr.eceuysal.nrs@gmail.com.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2022.04.046']
1138,35597057,Longitudinal Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga on Genitourinary Symptoms in Asian Women of Older Age: A Randomized Experimental Study.,"This parallel-two-group randomized experimental study including a supervised group and an unsupervised group examined the longitudinal effects of pelvic floor muscle training (PFMT) combined with yoga on genitourinary symptoms and the health-related quality of life (HRQOL), and compared practice adherence rates of the two groups. A sample of women experiencing ≥1 genitourinary symptom(s) were recruited and assigned to a supervised group or an unsupervised group. The supervised group attended supervised group practice sessions and performed at-home practice of PFMT and yoga. The unsupervised group performed at-home practice of PFMT and yoga. Information was collected at five time points (n = 91). Generalized estimating equation procedures were used to examine the intervention effects. An independent t-test was conducted to compare the practice adherence rates. Both groups' genitourinary symptoms and HRQOL significantly improved over time. The supervised group displayed greater improvements in genitourinary symptoms and HRQOL and better adherence than did the unsupervised group.",2022,Both groups' genitourinary symptoms and HRQOL significantly improved over time.,"['Asian Women of Older Age', 'A sample of women experiencing ≥1 genitourinary symptom(s']","['pelvic floor muscle training (PFMT) combined with yoga', 'supervised group attended supervised group practice sessions and performed at-home practice of PFMT and yoga', 'PFMT and yoga', 'Combined Program of Pelvic Floor Muscle Training and Yoga']","['Genitourinary Symptoms', 'genitourinary symptoms and HRQOL and better adherence', 'practice adherence rates', 'genitourinary symptoms and HRQOL', 'genitourinary symptoms and the health-related quality of life (HRQOL']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0426317', 'cui_str': 'Genitourinary symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.0140249,Both groups' genitourinary symptoms and HRQOL significantly improved over time.,"[{'ForeName': 'Hsiang-Tai', 'Initials': 'HT', 'LastName': 'Chao', 'Affiliation': 'Obstetrics and Gynecology Department, Taipei Veterans General Hospital, 201 Shi-Pai Road, Section 2, Taipei City 11217, Taiwan, Republic of China (R.O.C.); College of Medicine, National Yang Ming Chiao Tung University, 155 Li-Nong Street, Section 2, Taipei City 112, Taiwan, Republic of China (R.O.C.).'}, {'ForeName': 'Pi-Chen', 'Initials': 'PC', 'LastName': 'Chang', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wu-Xing Street, Xinyi District, Taipei City 110, Taiwan, Republic of China (R.O.C.).'}, {'ForeName': 'Yen-Kuang', 'Initials': 'YK', 'LastName': 'Lin', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, 250 Wenhua 1st Road, Guishan, Taoyuan 333, Taiwan, Republic of China (R.O.C.).'}, {'ForeName': 'Wen-Chen', 'Initials': 'WC', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Cathy General Hospital, 280 Ren-Ai Road, Section 4, Taipei City 106, Taiwan, Republic of China (R.O.C.); Department of Obstetrics and Gynecology, School of Medicine, College of Medicine, Taipei Medical University, 250 Wu-Xing Street, Xinyi District, Taipei City 110, Taiwan, Republic of China (R.O.C.).'}, {'ForeName': 'Chien-Chih', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Taipei Medical University Hospital, 252 Wu-Xing Street, Xinyi District, Taipei City 110, Taiwan, Republic of China (R.O.C.); Department of Education and Humanities in Medicine, School of Medicine, College of Medicine, Taipei Medical University, 250 Wu-Xing Street, Xinyi District, Taipei City 110, Taiwan, Republic of China (R.O.C.).'}, {'ForeName': 'Lu-I', 'Initials': 'LI', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, College of Medicine, Tzu Chi University, 701 Zhong-Yang Road, Section 3, Hualien City 97004, Taiwan, Republic of China (R.O.C.).'}, {'ForeName': 'Yuan-Mei', 'Initials': 'YM', 'LastName': 'Liao', 'Affiliation': 'Institute of Clinical Nursing, College of Nursing, National Yang Ming Chiao Tung University, 155 Li-Nong Street, Section 2, Taipei City 112, Taiwan, Republic of China (R.O.C.). Electronic address: ymliao@nycu.edu.tw.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.04.018']
1139,35598579,Palmitoylethanolamide-based nutraceutical Calmux® in preventive treatment of migraine.,"BACKGROUND


The aim of this study was to determine the efficacy and tolerability of treatment with a Palmitoylethanolamide (PEA)-based nutraceutical in patients with episodic migraine.
METHODS


A pilot, prospective, open-label experimental study was designed in which patients with episodic migraine with and without aura seen in the general practice office of a tertiary centre during a period of 6 month were offered the possibility to participate. No control group was included. All included patients were treated with nutraceutical Calmux® taken every 12 h for 3 months. Monthly attack frequency, attack intensity, impact of migraine (HIT-6 and MIDAS scales) and quality of sleep at baseline and after 3 months of treatment were compared.
RESULTS


Twenty-five patients (22 women and 3 men) were included, with a mean age of 36.3 ± 12 years. Headache days per month decreased from 10 ± 2.1 days to 6.6 ± 3.6 days (p < 0.00001). Days of analgesic use decreased from 9.2 ± 2.6 days to 4.1 ± 2.1 (p < 0.0001). None of the patients included suffered from adverse events attributable to treatment. Pain intensity showed a mean reduction of 3.1 points, from 8.1 at baseline to 5 at 3 months of treatment (p < 0.005).
CONCLUSIONS


PEA nutraceuticals could be useful in migraine prevention. Further studies are necessary, but we consider that PEA-based nutraceutical could be a new approach in the treatment of migraine patients.",2022,"Monthly attack frequency, attack intensity, impact of migraine (HIT-6 and MIDAS scales) and quality of sleep at baseline and after 3 months of treatment were compared.
","['patients with episodic migraine', 'migraine patients', 'patients with episodic migraine with and without aura seen in the general practice office of a tertiary centre during a period of 6 month', 'Twenty-five patients (22 women and 3 men) were included, with a mean age of 36.3\xa0±\xa012 years']","['nutraceutical Calmux®', 'Palmitoylethanolamide-based nutraceutical Calmux®', 'Palmitoylethanolamide (PEA)-based nutraceutical']","['Pain intensity', 'efficacy and tolerability', 'Monthly attack frequency, attack intensity, impact of migraine (HIT-6 and MIDAS scales) and quality of sleep']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C1309950', 'cui_str': 'GOLPH3 protein, human'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",25.0,0.0515674,"Monthly attack frequency, attack intensity, impact of migraine (HIT-6 and MIDAS scales) and quality of sleep at baseline and after 3 months of treatment were compared.
","[{'ForeName': 'Ayoze González', 'Initials': 'AG', 'LastName': 'Hernández', 'Affiliation': 'Neurology Department, Hospital Universitario de Gran Canaria Dr. Negrín, Faculty of Health Sciences, Universidad Fernando Pessoa Canarias, Spain. Electronic address: agonzalez@ufpcanarias.es.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2022.107282']
1140,35603416,Parent and child self- and co-regulation during pediatric venipuncture: Exploring heart rate variability and the effects of a mindfulness intervention.,"Needle procedures are common throughout childhood and often elicit distress in children and parents. Heart rate variability (HRV), as an index of emotion regulation, can inform both self-regulatory and co-regulatory processes. Mindfulness may serve to regulate distress; however, no research has studied mindfulness or parent and child regulatory responding concurrently during venipuncture. Stemming from a randomized controlled trial investigating a mindfulness intervention, this study sought to describe regulatory responding (via HRV) throughout pediatric venipuncture and the role of cognitive-affective factors (mindfulness, parent anxiety, catastrophizing) in 61 parent-child dyads (7-12 years). We examined (1) patterns of parent and child HRV throughout venipuncture and whether a brief, randomly assigned audio-guided mindfulness versus control exercise affected this pattern and (2) the extent to which changes in parent and child HRV were synchronized throughout venipuncture, and whether parent catastrophizing and anxiety moderated this association. HRV differed as a function of procedural phase. Practicing the mindfulness versus control exercise did not consistently affect HRV in dyads. Positive synchrony was observed during the end of the intervention in dyads with high parental catastrophizing. Otherwise, a pattern of nonsynchrony emerged. Results provide foundational knowledge regarding children's internal (self) and external (parent) regulation mechanisms. RCT registration: NCT03941717.",2022,Practicing the mindfulness versus control exercise did not consistently affect HRV in dyads.,"['children and parents', '61 parent-child dyads (7-12 years']","['pediatric venipuncture', 'mindfulness intervention', 'control exercise', 'audio-guided mindfulness versus control exercise']","['Positive synchrony', 'Heart rate variability (HRV), as an index of emotion regulation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0461568,Practicing the mindfulness versus control exercise did not consistently affect HRV in dyads.,"[{'ForeName': 'Kaytlin L', 'Initials': 'KL', 'LastName': 'Constantin', 'Affiliation': 'Department of Psychology, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Moline', 'Affiliation': 'Department of Psychology, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Pillai Riddell', 'Affiliation': 'Department of Psychology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Spence', 'Affiliation': 'Department of Psychology, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Chris M', 'Initials': 'CM', 'LastName': 'Fiacconi', 'Affiliation': 'Department of Psychology, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lupo-Flewelling', 'Affiliation': 'Department of Psychology, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'C Meghan', 'Initials': 'CM', 'LastName': 'McMurtry', 'Affiliation': 'Department of Psychology, University of Guelph, Guelph, Ontario, Canada.'}]",Developmental psychobiology,['10.1002/dev.22277']
1141,35604811,Chia Flour (Salvia hispanica L.) Intake Does Not Affect Weight Loss and Lipid Profile but Improve Systolic Blood Pressure Control in Obesity.,"BACKGROUND


Obesity is an epidemic, multifactorial and difficult-to-control disease, besides being a risk factor for cardiovascular diseases. Among the multiple intervention proposals, the addition of chia in meals has been considered due to its composition and possible effects on weight loss and cardiovascular parameters.
OBJECTIVE


We evaluate the influence of chia flour (Salvia hispanica L.) intake on body weight, body composition, energy expenditure (EE) and cardiovascular risk in obese women.
METHODS


This study is a clinical trial performed with 20 adult women with obesity randomized into experimental (chia flour) and control (placebo) groups. We assessed anthropometric and biochemical measurements, as well as clinical, dietary and EE variables before intervention and 90 days later.
RESULTS


There were no differences in anthropometric indicators, body composition or EE between groups, but a decrease in HDL-c (p = 0.049) and a trend towards the reduction of systolic blood pressure (SBP) (p = 0.062) was observed in the experimental group.
CONCLUSION


Chia flour had a possible positive effect on SBP control, but negatively affected the lipid profile and did not seem to influence obesity control.",2022,"There were no differences in anthropometric indicators, body composition or EE between groups, but a decrease in HDL-c (p = 0.049) and a trend towards the reduction of systolic blood pressure (SBP) (p = 0.062) was observed in the experimental group.
","['20 adult women with obesity randomized into', 'obese women']","['chia flour (Salvia hispanica L', 'Chia Flour (Salvia hispanica L', 'experimental (chia flour) and control (placebo']","['Systolic Blood Pressure Control in Obesity', 'systolic blood pressure (SBP', 'HDL-c', 'anthropometric indicators, body composition or EE', 'body weight, body composition, energy expenditure (EE) and cardiovascular risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3256719', 'cui_str': 'Salvia hispanica seed extract'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0331292', 'cui_str': 'Salvia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",20.0,0.0333854,"There were no differences in anthropometric indicators, body composition or EE between groups, but a decrease in HDL-c (p = 0.049) and a trend towards the reduction of systolic blood pressure (SBP) (p = 0.062) was observed in the experimental group.
","[{'ForeName': 'Laura Sampaio', 'Initials': 'LS', 'LastName': 'Quaresma', 'Affiliation': 'Departament of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Leysimar', 'Initials': 'L', 'LastName': 'de Oliveira Siais', 'Affiliation': 'Departament of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Érika Duarte', 'Initials': 'ÉD', 'LastName': 'Grangeiro', 'Affiliation': 'Departament of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Eliane Lopes', 'Initials': 'EL', 'LastName': 'Rosado', 'Affiliation': 'Departament of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}]",Journal of the American Nutrition Association,['10.1080/07315724.2022.2056773']
1142,35605529,Methamphetamine/amphetamine use over time among persons with opioid use disorders treated with buprenorphine/naloxone versus extended-release naltrexone.,"BACKGROUND


Methamphetamine use is increasing among persons with opioid use disorder (OUD). The study aims were to describe methamphetamine/amphetamine (MA/A) use among patients treated for OUD with buprenorphine/naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and to explore associations between treatment arm and MA/A use.
METHODS


Secondary analysis of data from a multi-site, open-label, randomized controlled trial of XR-NTX versus BUP-NX for 24 weeks. The outcome variable was MA/A use defined by either positive urine drug toxicology or self-report. The main predictor was treatment assignment (BUP-NX v. XR-NTX). Longitudinal mixed-effects logistic regression models were fit to model the odds of MA/A use during the study. Additional predictors included study visit and baseline MA/A use.
RESULTS


Among the sample of 570 participants with OUD, baseline use of MA/A was observed in 105 (18.4%). There was no significant treatment effect over the study period, though BUP-NX subjects, on average, had about half the odds of MA/A use compared to XR-NTX subjects (OR=0.50; p = 0.051). In the same model, baseline MA/A use and study visit were both significantly associated with MA/A use over time.
CONCLUSION


In this sample of treated OUD patients, nearly a fifth of participants had MA/A use at baseline and the frequency of use did not decline over time: in fact, the odds of use slightly increased for each later visit. These secondary analyses found no significant difference in MA/A use between BUP-NX and XR-NTX treatment arms, however, the observation of less MA/A in the buprenorphine arm merits further investigation.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov (NCT02032433).",2022,"These secondary analyses found no significant difference in MA/A use between BUP-NX and XR-NTX treatment arms, however, the observation of less MA/A in the buprenorphine arm merits further investigation.
","['570 participants with OUD, baseline use of MA/A was observed in 105 (18.4', 'persons with opioid use disorders treated with', 'patients treated for OUD with', 'persons with opioid use disorder (OUD', 'Secondary analysis of data from a multi-site, open-label']","['Methamphetamine', 'XR-NTX versus BUP-NX', 'buprenorphine/naloxone', 'methamphetamine/amphetamine (MA/A', 'naltrexone', 'Methamphetamine/amphetamine', 'buprenorphine/naloxone (BUP-NX) or extended-release naltrexone (XR-NTX', 'buprenorphine']",['MA/A use defined by either positive urine drug toxicology or self-report'],"[{'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",570.0,0.0381605,"These secondary analyses found no significant difference in MA/A use between BUP-NX and XR-NTX treatment arms, however, the observation of less MA/A in the buprenorphine arm merits further investigation.
","[{'ForeName': 'Judith I', 'Initials': 'JI', 'LastName': 'Tsui', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, 1959 NE Pacific Street, Seattle, WA 98195-6420, USA. Electronic address: tsuij@uw.edu.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Dr, New York, NY 10032, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University, 722 West 168th St., New York, NY 10032, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Dr, New York, NY 10032, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, New York University, 550 First Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Ryan R', 'Initials': 'RR', 'LastName': 'Cook', 'Affiliation': 'Department of Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA.'}, {'ForeName': 'Matisyahu', 'Initials': 'M', 'LastName': 'Shulman', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Dr, New York, NY 10032, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Dr, New York, NY 10032, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Psychiatry, New York University, 550 First Avenue, New York, NY 10016, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109469']
1143,35605520,Eustachian tube insufflation with thermal water: Effectiveness in the treatment of pediatric otitis media with effusion.,"PURPOSE


Otitis media with effusion (OME) is the most common ear disease in childhood. The hearing loss associated with OME impacts on children's language development and behavior. Eustachian tube insufflation are among possible treatments for OME, but data regarding their effectiveness are scarce. The aim of this investigation was to analyze the effect of inhalatory thermal therapy and Eustachian tube insufflation in a consecutive cohort of pediatric patients with OME.
MATERIALS AND METHODS


Seventy-four pediatric patients referred for OME to the thermal medical center ""La Contea"" (Battaglia Terme, Padova, Italy) were considered. Data from tympanometry and pure tone audiometry performed immediately before (T0), at the end of treatment (T1) and at a follow-up control (T2) were analyzed.
RESULTS


Data from 148 ears were available. The pressure values of tympanometry significantly improved from T0 to T1 (p = 0.0001), and further improvement was recorded at T2, when 60.8% of patients had normal tympanograms. A significant gain of the air-conduction threshold in the T0-T2 interval was observed (p = 0.0001). At otoscopy, a significant reduction of tympanic membranes with fluid or air-fluid levels presence (p < 0.00001) and a significant increase of normal tympanic membranes (p = 0.0001) were found.
CONCLUSION


Eustachian tube insufflation represented a well-tolerated and effective treatment in children with OME. Further investigations should deepen these results in randomized, double-blind settings, possibly with long-term follow-up periods. A quality-of-life and cost-effectiveness evaluation of this treatment approach for pediatric OME could be helpful for public health decision-making.",2022,"The pressure values of tympanometry significantly improved from T0 to T1 (p = 0.0001), and further improvement was recorded at T2, when 60.8% of patients had normal tympanograms.","['children with OME', 'pediatric patients with OME', 'pediatric otitis media with effusion', 'Data from 148 ears were available', 'Seventy-four pediatric patients referred for OME to the thermal medical center ""La Contea"" (Battaglia Terme, Padova, Italy) were considered', 'Otitis media with effusion (OME']","['Eustachian tube insufflation', 'Eustachian tube insufflation with thermal water', 'inhalatory thermal therapy and Eustachian tube insufflation']","['pressure values of tympanometry', 'tympanic membranes with fluid or air-fluid levels presence', 'normal tympanic membranes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029883', 'cui_str': 'Middle ear effusion'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0015183', 'cui_str': 'Structure of pharyngotympanic tube'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0454527', 'cui_str': 'Thermal techniques'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry testing'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",148.0,0.0805235,"The pressure values of tympanometry significantly improved from T0 to T1 (p = 0.0001), and further improvement was recorded at T2, when 60.8% of patients had normal tympanograms.","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Fermo', 'Affiliation': 'Department of Neuroscience, Audiology Unit, University of Padova, Treviso, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Frosolini', 'Affiliation': 'Department of Neuroscience, Audiology Unit, University of Padova, Treviso, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Parrino', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi, Varese, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Chiappetta', 'Affiliation': 'Thermal Medical Center ""La Contea"", Battaglia Terme, Padova, Italy.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Marioni', 'Affiliation': 'Department of Neuroscience, Section of Otolaryngology, University of Padova, Padova, Italy. Electronic address: gino.marioni@unipd.it.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'de Filippis', 'Affiliation': 'Department of Neuroscience, Audiology Unit, University of Padova, Treviso, Italy.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2022.103504']
1144,35605475,The influence of a glucose administration on stress responsivity and memory after a socially evaluated cold pressor test.,"The nutritional state of participants prior to stress induction via a laboratory stressor has been demonstrated to influence reactivity of the Hypothalamus-Pituitary-Adrenal axis. So far, either primarily psychosocial or primarily physiological stressors have been utilized investigating this effect. In the present study, we aimed to fill this gap in the existing literature by utilizing a stressor that combines both elements, namely the Socially Evaluated Cold Pressor Test. Furthermore, we investigated how glucose consumption and subsequent stress induction influence long-term memory retrieval as well as working memory. In a 2 × 2 design, half of the 72 participants (36 women, 36 men) participated in the laboratory stressor while the other half participated in a control condition after having fasted for at least six hours. Thirty minutes prior to stress or control treatment, fasted participants consumed either 75 g of glucose or stevia-sweetened water. Salivary cortisol levels, systolic and diastolic blood pressure, as well as affect did not significantly differ between participants consuming glucose or the placebo beverage. Acute stress impaired working memory but had no effect on long-term memory retrieval. Glucose consumption did not significantly influence memory. Our results suggest that the intensity of a stressor might be important when determining the effects of a glucose administration on stress reactivity. The nutritional state of participants taking part in studies investigating the effects of acute stress on memory might be less decisive than previously assumed.",2022,"Salivary cortisol levels, systolic and diastolic blood pressure, as well as affect did not significantly differ between participants consuming glucose or the placebo beverage.","['72 participants (36 women, 36 men) participated in the laboratory stressor while the other half participated in a control condition after having fasted for at least six hours']","['75\xa0g of glucose or stevia-sweetened water', 'glucose administration']","['Salivary cortisol levels, systolic and diastolic blood pressure', 'glucose consumption and subsequent stress induction influence long-term memory retrieval as well as working memory', 'stress responsivity and memory', 'Glucose consumption']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439227', 'cui_str': 'hour'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0075246', 'cui_str': 'stevioside'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0423909', 'cui_str': 'Long-term memory performance'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0342881,"Salivary cortisol levels, systolic and diastolic blood pressure, as well as affect did not significantly differ between participants consuming glucose or the placebo beverage.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Rüttgens', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr University Bochum, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr University Bochum, Germany. Electronic address: oliver.t.wolf@rub.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2022.105803']
1145,35605902,A lack of timing-dependent effects of transcranial direct current stimulation (tDCS) on the performance of a choice reaction time task.,"Anodal transcranial direct current stimulation (tDCS) can enhance the retention of a previously practiced motor skill. However, the effects of tDCS on the performance of the choice reaction time task are not fully understood. We examined the effects of anodal tDCS over the left primary motor cortex (M1) on the retention of a 4-choice visual-motor reaction time task (4-ChRT). Right-handed healthy participants (n = 100) were randomly assigned to five groups: three groups received anodal tDCS: before (tDCS before ), during (tDCS during ), or after (tDCS after ) motor practice. In addition, there were two control groups: with (CON mp ) and without (CON) motor practice. We evaluated the speed and precision of the 4-ChRT task before (PRE), during, and 24 h (POST) after the interventions. All groups, including the non-stimulation (CON mp ) and non-practice groups (CON), improved (p < 0.05) motor retention (Δ4-ChRT: 35.8 ± 36.0 ms). These findings suggest that the tDCS effects over M1 may differ for serial versus choice RT tasks, perhaps due to the different brain areas involved in each motor task.",2022,"All groups, including the non-stimulation (CON mp ) and non-practice groups (CON), improved (p<0.05) motor retention (Δ4-ChRT: 35.8 ± 36.0 ms).",['Right-handed healthy participants (n=100'],"['Anodal transcranial direct current stimulation (tDCS', 'tDCS', 'anodal tDCS', 'transcranial direct current stimulation (tDCS']",['retention of a 4-choice visual-motor reaction time task (4-ChRT'],"[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",100.0,0.0379107,"All groups, including the non-stimulation (CON mp ) and non-practice groups (CON), improved (p<0.05) motor retention (Δ4-ChRT: 35.8 ± 36.0 ms).","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sevilla-Sanchez', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Motor Control Group, A Coruña, Spain.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Hortobágyi', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen, Grioningen, The Netherlands; Institute of Sport Sciences and Physical Education, Faculty of Sciences, University of Pécs, Pécs, Hungary; Somogy County Kaposi Mór Teaching Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Carballeira', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Motor Control Group, A Coruña, Spain.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Fogelson', 'Affiliation': 'Department of Humanities, King Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernandez-Del-Olmo', 'Affiliation': 'Area of Sport Sciences, Faculty of Sports Sciences and Physical Education, Center for Sports Studies, King Juan Carlos University, Madrid, Spain. Electronic address: Miguel.delolmo@urjc.es.'}]",Neuroscience letters,['10.1016/j.neulet.2022.136691']
1146,35589070,Nutrition Literacy Among Latina/x People During Pregnancy Is Associated With Socioeconomic Position.,"BACKGROUND


During pregnancy, Latina/x people experience nutrition and nutrition-related health inequities. Nutrition literacy is a potential factor impacted by these inequities. However, the nutrition literacy level of Latina/x people during pregnancy is not well investigated.
OBJECTIVES


The study aimed to assess the nutrition literacy level of Latina/x people during pregnancy and explore the association of nutrition literacy with socioeconomic position.
DESIGN


This was a cross-sectional study of data collected from 2016 to 2018 within the double-blinded, randomized clinical trial Assessment of Docosahexaenoic Acid on Reducing Early Preterm Birth.
PARTICIPANTS/SETTING


A total of 112 Latina/x people during pregnancy from the Kansas City metro area were included in this study.
MAIN OUTCOME MEASURES


Nutrition literacy level assessed between 12 and 20 gestational weeks using the Nutrition Literacy Assessment Instrument, both in English and Spanish.
STATISTICAL ANALYSES PERFORMED


Descriptive measures were used to describe the nutrition literacy level during pregnancy. Multiple logistic regression models were used to examine the association between low nutrition literacy and socioeconomic position, adjusting for age and race.
RESULTS


In this study, most participants demonstrated low nutrition literacy during pregnancy. Those with low nutrition literacy were 2 times more likely to have low annual household income (odds ratio [OR] = 2.74, 95% confidence interval [CI]: 0.99-7.59), 3 times more likely to prefer Spanish as their primary language of communication (OR = 3.03, 95% CI: 0.95-9.67), and 7 times more likely to be uninsured (OR = 7.47; 95% CI: 1.57-35.64).
CONCLUSIONS


Nutrition literacy scores during pregnancy were associated with variables of socioeconomic position. Future research should focus on nutrition literacy associations with health outcomes during pregnancy and interventions to improve the nutrition literacy level of primarily Spanish-speaking people who have low household incomes and are uninsured.",2022,"Those with low nutrition literacy were two times more likely to have low annual household income (OR=2.74, 95%CI: 0.99,7.59), three times more likely to prefer Spanish as their primary language of communication (OR=3.03, 95%CI: 0.95,9.67), and seven times more likely to be uninsured (OR=7.47; 95%CI: 1.57, 35.64).
","['A total of 112 Latina', 'x people during pregnancy from the Kansas City metro area', 'Nutrition Literacy Among Latina', 'primarily Spanish-speaking people who have low household incomes and are uninsured']",['Docosahexaenoic Acid'],"['Early preterm birth (ADORE', 'nutrition literacy level of Latina', 'Nutrition literacy level assessed between 12 to 20 gestational weeks using the Nutrition Literacy Assessment Instrument, both in English (NLit) and Spanish (NLit-S', 'low nutrition literacy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0557165', 'cui_str': 'Low household income'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.155072,"Those with low nutrition literacy were two times more likely to have low annual household income (OR=2.74, 95%CI: 0.99,7.59), three times more likely to prefer Spanish as their primary language of communication (OR=3.03, 95%CI: 0.95,9.67), and seven times more likely to be uninsured (OR=7.47; 95%CI: 1.57, 35.64).
","[{'ForeName': 'Juliana T', 'Initials': 'JT', 'LastName': 'Camargo', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas; Department of Urology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': 'JUNTOS Center for Advancing Latino Health, Department of Population Health, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Carlson', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Gibbs', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas. Electronic address: hgibbs@kumc.edu.'}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2022.05.011']
1147,35590274,Comparison of long-term effects of exergaming (Xbox one kinet) and companionship programs on attitude towards dementia and the older adults among adolescents: a quasi-experimental longitudinal study.,"BACKGROUND


Many studies have been performed on the use of intergenerational programs to improve the negative attitudes and misunderstandings of adolescents toward older people with dementia. However, the findings of these studies are inconclusive. The aim of this study was to compare the long-term effects of exergaming (Kinect) and companionship programs on attitudes toward dementia and the elderly among adolescents.
METHODS


A quasi-experimental longitudinal design was used. A total of 200 adolescents aged 12-18 years old were recruited from nine schools in northern Taiwan. The adolescents were assigned to five different groups, namely, a 5-week exergaming group, a 5-week companion group, an 8-week exergaming group, an 8-week companion group, and a control group, using a single blinding procedure. Data collection was performed pretest, post-test and at 1, 3 and 6 months after the post-test. The long-term effects of the two programs (i.e., exergaming and companionship) were analyzed using a generalized estimating equation.
RESULTS


Regarding attitudes toward dementia, the 8-week exergaming group had a significantly better attitude than the control group at the 6-month follow-up (p < 0.001). Similarly, the results of the 8-week companion group also showed a significantly improved attitude compared with the control group at the 6-month follow-up (p = 0.041). Regarding attitudes toward the elderly, the 8-week exergaming group had a significantly better attitude than the control group at the 6-month follow-up (p < 0.001). The 8-week companion group had a similar effect on better attitude compared with the control group at the 6-month follow-up (p = 0.016). Furthermore, the 5-week companion group showed a significant improvement compared with the control group at the 6-month follow-up (p = 0.004).
CONCLUSIONS


Spending companionship time with older adults is beneficial for improving the attitudes of adolescents toward the elderly. Furthermore, exergaming improves the attitudes of adolescents toward both dementia and older adults.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR2100053003 . Retrospectively registered on 07/11/2021.",2022,The 8-week companion group had a similar effect on better attitude compared with the control group at the 6-month follow-up (p = 0.016).,"['attitudes toward dementia and the elderly among adolescents', 'adolescents toward older people with dementia', '200 adolescents aged 12-18\xa0years old were recruited from nine schools in northern Taiwan', 'attitude towards dementia and the older adults among adolescents']","['exergaming (Xbox one kinet) and companionship programs', 'exergaming (Kinect) and companionship programs']","['attitude', 'better attitude']","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}]",200.0,0.0493631,The 8-week companion group had a similar effect on better attitude compared with the control group at the 6-month follow-up (p = 0.016).,"[{'ForeName': 'Yuan-Ju', 'Initials': 'YJ', 'LastName': 'Liao', 'Affiliation': 'Department of Nursing, National Yang Ming Chiao Tung University, No.155, Section 2, Li-Nong Street, Beitou District, Taipei, Taiwan.'}, {'ForeName': 'Li-Chan', 'Initials': 'LC', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Asia University, No. 500, Lioufeng Road, Wufeng District, Taichung, 41354, Taiwan. lichan2009@gmail.com.'}, {'ForeName': 'Shiao-Chi', 'Initials': 'SC', 'LastName': 'Wu', 'Affiliation': 'Institute of Health and Welfare Policy, National Yang Ming Chiao Tung University, No.155, Section 2, Li-Nong Street, Beitou District, Taipei, Taiwan.'}, {'ForeName': 'Jung-Ling', 'Initials': 'JL', 'LastName': 'Fuh', 'Affiliation': 'Faculty of Medicine, Schools of Medicine, National Yang Ming Chiao Tung University School, No.155, Section 2, Li-Nong Street, Beitou District, Taipei, Taiwan.'}, {'ForeName': 'I-Tsun', 'Initials': 'IT', 'LastName': 'Chiang', 'Affiliation': ""Department of Special Education, National Taiwan Normal University, No. 162, Section 1, Heping East Road., Da' an District, Taipei, Taiwan.""}, {'ForeName': 'Bih-Shya', 'Initials': 'BS', 'LastName': 'Gau', 'Affiliation': 'School of Nursing, College of Medicine, National Taiwan University, No. 1, Jen-Ai Road, Section 1, Zhongzheng District, Taipei, Taiwan.'}]",BMC geriatrics,['10.1186/s12877-022-03137-w']
1148,35593174,"Immunogenicity, safety, and antiphospholipid antibodies after SARS-CoV-2 vaccine in patients with primary antiphospholipid syndrome.","OBJECTIVE


Coronavirus disease 19 (COVID-19) has an increased risk of coagulopathy with high frequency of antiphospholipid antibodies (aPL). Recent reports of thrombosis associated with adenovirus-based vaccines raised concern that SARS-CoV-2 immunization in primary antiphospholipid syndrome (PAPS) patients may trigger clotting complications. Our objectives were to assess immunogenicity, safety, and aPL production in PAPS patients, after vaccinating with Sinovac-CoronaVac, an inactivated virus vaccine against COVID-19.
METHODS


This prospective controlled phase-4 study of PAPS patients and a control group (CG) consisted of a two-dose Sinovac-CoronaVac (D0/D28) and blood collection before vaccination (D0), at D28 and 6 weeks after second dose (D69) for immunogenicity/aPL levels. Outcomes were seroconversion (SC) rates of anti-SARS-CoV-2 S1/S2 IgG and/or neutralizing antibodies (NAb) at D28/D69 in naïve participants. Safety and aPL production were also assessed.
RESULTS


We included 44 PAPS patients (31 naïve) and 132 CG (108 naïve) with comparable age ( p =0.982) and sex ( p >0.999). At D69, both groups had high and comparable SC (83.9% vs. 93.5%,  p =0.092), as well as NAb positivity (77.4% vs. 78.7%,  p =0.440), and NAb-activity (64.3% vs. 60.9%,  p =0.689). Thrombotic events up to 6 months or other moderate/severe side effects were not observed. PAPS patients remained with stable aPL levels throughout the study at D0 vs. D28 vs. D69: anticardiolipin (aCL) IgG ( p =0.058) and IgM ( p =0.091); anti-beta-2 glycoprotein I (aβ2GPI) IgG ( p =0.513) and IgM ( p =0.468).
CONCLUSION


We provided novel evidence that Sinovac-CoronaVac has high immunogenicity and safety profile in PAPS. Furthermore, Sinovac-CoronaVac did not trigger thrombosis nor induced changes in aPL production.",2022,"anti-beta-2 glycoprotein I (aβ2GPI) IgG ( p =0.513) and IgM ( p =0.468).
","['patients with primary antiphospholipid syndrome', 'naïve participants', '44 PAPS patients (31 naïve) and 132 CG (108 naïve) with comparable age ( p =0.982) and sex ( p >0.999', 'PAPS patients, after vaccinating with Sinovac-CoronaVac, an inactivated virus vaccine against COVID-19', 'primary antiphospholipid syndrome (PAPS) patients']","['SARS-CoV-2 vaccine', 'anticardiolipin', 'PAPS']","['aPL production', 'seroconversion (SC) rates of anti-SARS-CoV-2 S1/S2 IgG', 'immunogenicity, safety, and aPL production', 'severe side effects', 'stable aPL levels', 'NAb positivity', 'Safety and aPL production', 'Immunogenicity, safety, and antiphospholipid antibodies', 'NAb-activity', 'Thrombotic events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409980', 'cui_str': 'Primary antiphospholipid syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}]","[{'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0162595', 'cui_str': 'Anti-phospholipid antibody'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",44.0,0.0726201,"anti-beta-2 glycoprotein I (aβ2GPI) IgG ( p =0.513) and IgM ( p =0.468).
","[{'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Signorelli', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Gustavo Guimarães Moreira', 'Initials': 'GGM', 'LastName': 'Balbi', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Nadia E', 'Initials': 'NE', 'LastName': 'Aikawa', 'Affiliation': 'Pediatric Rheumatology Unit, Instituto da Criança, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Clovis A', 'Initials': 'CA', 'LastName': 'Silva', 'Affiliation': 'Pediatric Rheumatology Unit, Instituto da Criança, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Léonard de Vinci Kanda', 'Initials': 'LVK', 'LastName': 'Kupa', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Medeiros-Ribeiro', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Emily Fn', 'Initials': 'EF', 'LastName': 'Yuki', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Sandra G', 'Initials': 'SG', 'LastName': 'Pasoto', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Carla Gs', 'Initials': 'CG', 'LastName': 'Saad', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Eduardo F', 'Initials': 'EF', 'LastName': 'Borba', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Luciana Parente Costa', 'Initials': 'LPC', 'LastName': 'Seguro', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Pedrosa', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Vitor Antonio de Angeli', 'Initials': 'VAA', 'LastName': 'Oliveira', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': ""Ana Luisa Cerqueira de Sant'Ana"", 'Initials': 'ALCS', 'LastName': 'Costa', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Carolina T', 'Initials': 'CT', 'LastName': 'Ribeiro', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Roseli Eliana Beseggio', 'Initials': 'REB', 'LastName': 'Santos', 'Affiliation': 'Central Laboratory Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Danieli Castro Oliveira', 'Initials': 'DCO', 'LastName': 'Andrade', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Bonfá', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.'}]",Lupus,['10.1177/09612033221102073']
1149,35595658,"Corrigendum to ""A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: clinical results and biomarker analysis of GeparNuevo study"": [Annals of Oncology (2019), volume 30:1279-1288].",,2022,,['early triple-negative breast cancer'],['anthracycline taxane-based neoadjuvant therapy'],[],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]",[],,0.0369481,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg; Oncological Practice Bethanien, Cancer Center Frankfurt Northeast, Frankfurt am Main. Electronic address: sibylle.loibl@gbg.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'HELIOS Klinikum Berlin-Buch, Berlin.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Burchardi', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Brustzentrum, Universitätsfrauenklinik Ulm, Ulm.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin; Berlin Institute of Health (BIH), Berlin.'}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Gynäkologie mit Brustzentrum, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'E-M', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': 'Universitätsfrauenklinik Tübingen, Tübingen.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Furlanetto', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Oncological Practice Bethanien, Cancer Center Frankfurt Northeast, Frankfurt am Main.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum München Frauenklinik, München.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Engels', 'Affiliation': 'Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss, Neuss.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rezai', 'Affiliation': 'Medical Center, Luisenkrankenhaus Düsseldorf, Düsseldorf.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Brustzentrum, Sana-Klinikum Offenbach, Offenbach.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thomalla', 'Affiliation': 'Praxisklinik für Hämatologie und Onkologie Koblenz, Koblenz.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Breast Unit, Kliniken Essen-Mitte, Essen.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Rautenberg', 'Affiliation': 'Klinik für Frauenheilkunde, Universitätsklinikum Freiburg, Freiburg.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Brustzentrum, Universitätsklinikum Erlangen, Erlangen.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rhiem', 'Affiliation': 'Center for Hereditary Breast and Ovarian Cancer, University Hospital Cologne, Cologne.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2022.04.003']
1150,35597518,Cerebellar transcranial direct current stimulation modulates timing but not acquisition of conditioned eyeblink responses in SCA3 patients.,"BACKGROUND


Delay eyeblink conditioning is an extensively studied motor learning paradigm that critically depends on the integrity of the cerebellum. In healthy individuals, modulation of cerebellar excitability using transcranial direct current stimulation (tDCS) has been reported to alter the acquisition and/or timing of conditioned eyeblink responses (CRs). It remains unknown whether such effects can also be elicited in patients with cerebellar disorders.
OBJECTIVE


To investigate if repeated sessions of cerebellar tDCS modify acquisition and/or timing of CRs in patients with spinocerebellar ataxia type 3 (SCA3) and to evaluate possible associations between disease severity measures and eyeblink conditioning parameters.
METHODS


Delay eyeblink conditioning was examined in 20 mildly to moderately affected individuals with SCA3 and 31 healthy controls. After the baseline assessment, patients were randomly assigned to receive ten sessions of cerebellar anodal tDCS or sham tDCS (i.e., five days per week for two consecutive weeks). Patients and investigators were blinded to treatment allocation. The same eyeblink conditioning protocol was administered directly after the last tDCS session. The Scale for the Assessment and Rating of Ataxia (SARA), cerebellar cognitive affective syndrome scale (CCAS-S), and disease duration were used as clinical measures of disease severity.
RESULTS


At baseline, SCA3 patients exhibited significantly fewer CRs than healthy controls. Acquisition was inversely associated with the number of failed CCAS-S test items but not with SARA score. Onset and peak latencies of CRs were longer in SCA3 patients and correlated with disease duration. Repeated sessions of cerebellar anodal tDCS did not affect CR acquisition, but had a significant treatment effect on both timing parameters. While a shift of CRs toward the conditioned stimulus was observed in the sham group (i.e., timing became more similar to that of healthy controls, presumably reflecting the effect of a second eyeblink conditioning session), anodal tDCS induced a shift of CRs in the opposite direction (i.e., toward the unconditioned stimulus).
CONCLUSION


Our findings provide evidence that cerebellar tDCS is capable of modifying cerebellar function in SCA3 patients. Future studies should assess whether this intervention similarly modulates temporal processing in other degenerative ataxias.",2022,"Repeated sessions of cerebellar anodal tDCS did not affect CR acquisition, but had a significant treatment effect on both timing parameters.","['20 mildly to moderately affected individuals with SCA3 and 31 healthy controls', 'patients with cerebellar disorders', 'SCA3 patients', 'patients with spinocerebellar ataxia type 3 (SCA3', 'healthy individuals']","['transcranial direct current stimulation (tDCS', 'cerebellar anodal tDCS or sham tDCS', 'cerebellar tDCS modify acquisition and/or timing of CRs']","['CR acquisition', 'Scale for the Assessment and Rating of Ataxia (SARA), cerebellar cognitive affective syndrome scale (CCAS-S), and disease duration', 'Onset and peak latencies of CRs', 'CRs']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024408', 'cui_str': 'Azorean disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007760', 'cui_str': 'Cerebellar disorder'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}]","[{'cui': 'C4760258', 'cui_str': 'Ataxia assessment scale'}, {'cui': 'C2609040', 'cui_str': 'Cerebellar cognitive affective syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}]",,0.0438361,"Repeated sessions of cerebellar anodal tDCS did not affect CR acquisition, but had a significant treatment effect on both timing parameters.","[{'ForeName': 'Roderick P P W M', 'Initials': 'RPPWM', 'LastName': 'Maas', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: roderick.maas@radboudumc.nl.'}, {'ForeName': 'Dennis J L G', 'Initials': 'DJLG', 'LastName': 'Schutter', 'Affiliation': 'Experimental Psychology, Helmholtz Institute, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Toni', 'Affiliation': 'Donders Institute for Brain, Cognition, and Behaviour, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Timmann', 'Affiliation': 'Department of Neurology and Center for Translational Neuro- and Behavioral Sciences (C-TNBS), Essen University Hospital, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Bart P C', 'Initials': 'BPC', 'LastName': 'van de Warrenburg', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",Brain stimulation,['10.1016/j.brs.2022.05.013']
1151,35597471,Efficacy and safety of vortioxetine in treatment of patients with major depressive disorder and common co-morbid physical illness.,"BACKGROUND


The multimodal antidepressant vortioxetine is effective in reducing somatic symptoms in patients with major depressive disorder (MDD), but little is known about its effects in reducing depressive symptoms in patients with common comorbid physical illnesses.
METHODS


This was a pooled analysis of 13 randomized, placebo-controlled trials which evaluated the efficacy (using the Montgomery-Åsberg Depression Rating Scale [MADRS]) and safety of vortioxetine (5-20 mg/day) in adult patients with MDD. We evaluated stable somatic comorbid conditions that were verified by a diagnosis and had sufficient database representation.
RESULTS


Of the 5982 patients included in the database, 963 (16.1%) patients had a diagnosis of cardiovascular disease, 152 (2.5%) had diabetes mellitus and 26 (0.4%) had chronic obstructive pulmonary disorder (COPD). At Week 8, adjusted mean[95%CI] treatment differences (vortioxetine vs. placebo) on MADRS total scores were -2.7[-4.2, -1.3] (p = 0.0002) points for the cardiovascular disease, -4.0[-7.7, -0.4] (p = 0.03) for the diabetes, and -6.2[-21.3, 8.9] (p = 0.36) for the COPD groups. The rate and pattern of adverse events were similar across the sub-groups with comorbidities and was consistent with that expected for vortioxetine treatment.
LIMITATIONS


The primary studies were not designed to investigate the relationship between vortioxetine and comorbidities, nor were the post hoc analyses powered to detect group differences.
CONCLUSIONS


Patients with MDD and comorbid cardiovascular disease or diabetes respond to vortioxetine in a similar way to the broader MDD population. Vortioxetine was generally safe and well tolerated and without unexpected adverse events in these subpopulations, most of whom are taking multiple concomitant medications.",2022,"At Week 8, adjusted mean[95%CI] treatment differences (vortioxetine vs. placebo) on MADRS total scores were -2.7[-4.2, -1.3] (p = 0.0002) points for the cardiovascular disease, -4.0[-7.7, -0.4] (p = 0.03) for the diabetes, and -6.2[-21.3, 8.9] (p = 0.36) for the COPD groups.","['patients with major depressive disorder and common co-morbid physical illness', 'Patients with MDD and comorbid cardiovascular disease or diabetes respond to', '5982 patients included in the database, 963 (16.1%) patients had a diagnosis of cardiovascular disease, 152 (2.5%) had diabetes mellitus and 26 (0.4%) had chronic obstructive pulmonary disorder (COPD', 'patients with major depressive disorder (MDD', 'patients with common comorbid physical illnesses', 'adult patients with MDD']","['vortioxetine', 'vortioxetine vs. placebo', 'Vortioxetine', 'placebo']","['MADRS total scores', 'rate and pattern of adverse events', 'Efficacy and safety', 'safe and well tolerated', 'Montgomery-Åsberg Depression Rating Scale [MADRS]) and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",5982.0,0.0808483,"At Week 8, adjusted mean[95%CI] treatment differences (vortioxetine vs. placebo) on MADRS total scores were -2.7[-4.2, -1.3] (p = 0.0002) points for the cardiovascular disease, -4.0[-7.7, -0.4] (p = 0.03) for the diabetes, and -6.2[-21.3, 8.9] (p = 0.36) for the COPD groups.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Baldwin', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; University Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa. Electronic address: D.S.Baldwin@soton.ac.uk.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Necking', 'Affiliation': 'H. Lundbeck A/S; Valby, Denmark.'}, {'ForeName': 'Simon Nitschky', 'Initials': 'SN', 'LastName': 'Schmidt', 'Affiliation': 'H. Lundbeck A/S; Valby, Denmark.'}, {'ForeName': 'Hongye', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'H. Lundbeck A/S; Valby, Denmark.'}, {'ForeName': 'Elin H', 'Initials': 'EH', 'LastName': 'Reines', 'Affiliation': 'H. Lundbeck A/S; Valby, Denmark.'}]",Journal of affective disorders,['10.1016/j.jad.2022.05.098']
1152,35603644,Familial caregiving following stroke: findings from the comprehensive post-acute stroke services (COMPASS) pragmatic cluster-randomized transitional care study.,"BACKGROUND


Stroke patients discharged home often require prolonged assistance from caregivers. Little is known about the real-world effectiveness of a comprehensive stroke transitional care intervention on relieving caregiver strain.
OBJECTIVES


To describe the effect of the COMPASS transitional care (COMPASS-TC) intervention on caregiver strain and characterize the types, duration, and intensity of caregiving.
METHODS


The cluster-randomized COMPASS pragmatic trial evaluated the effectiveness of COMPASS-TC versus usual care with patients with mild stroke and TIA at 40 hospitals in North Carolina, USA. Of 5882 patients enrolled, 4208 (71%) identified a familial caregiver. A follow-up Caregiver Questionnaire, including the Modified Caregiver Strain Index, was administered at approximately three months post-discharge. Demographics and frequency, duration, and intensity of caregiving were compared between groups.
RESULTS


1228 caregivers (29%) completed the questionnaire. Completion was positively associated with older patient age, white race, and spousal relationship. One-third of the caregivers provided ≥30 hours of care per week and 889 (79%) provided care ≥9 weeks. Average standardized caregiver strain was 21.9 (0-100), increasing with stroke severity and comorbidity burden. Women caregivers reported higher strain than men. Treatment allocation was not associated with caregiver strain.
CONCLUSIONS


This sample of mild stroke and TIA survivors received significant assistance from familial caregivers. However, caregiver strain was relatively low. Findings support the importance of familial caregiving in stroke, the continued disproportionate burden on women within the family, and the need for future research on caregiver support.",2022,"A follow-up Caregiver Questionnaire, including the Modified Caregiver Strain Index, was administered at approximately three months post-discharge.","['patients with mild stroke and TIA at 40 hospitals in North Carolina, USA', '5882 patients enrolled, 4208 (71%) identified a familial caregiver', '1228 caregivers (29%) completed the questionnaire', 'Stroke patients discharged home often require prolonged assistance from caregivers']","['COMPASS-TC', 'COMPASS transitional care (COMPASS-TC) intervention']","['caregiver strain and characterize the types, duration, and intensity of caregiving', 'stroke severity and comorbidity burden', 'Demographics and frequency, duration, and intensity of caregiving']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",5882.0,0.101992,"A follow-up Caregiver Questionnaire, including the Modified Caregiver Strain Index, was administered at approximately three months post-discharge.","[{'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Lutz', 'Affiliation': 'School of Nursing, College of Health and Human Services, University of North Carolina Wilmington, Wilmington, North Carolina, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kucharska-Newton', 'Affiliation': 'College of Public Health, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Psioda', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Sylvia W', 'Initials': 'SW', 'LastName': 'Coleman', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'College of Public Health, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Meghan D', 'Initials': 'MD', 'LastName': 'Radman', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Levy', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Janet Prvu', 'Initials': 'JP', 'LastName': 'Bettger', 'Affiliation': 'School of Medicine, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, USA.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Chou', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Celestino', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2022.2077520']
1153,35603590,"Short-term intestinal effects of water intake in fibre supplementation in healthy, low-habitual fibre consumers: a phase 2 clinical trial.","A randomised clinical trial was conducted on 20 healthy, low-habitual fibre consumers to assess the short-term effects of water intake (2 l/day) on fibre supplementation with wheat bran, pectin, and green banana flour. During the 14-days trial, fibre intake doubled in both fibre ( n  = 10) and fibre/water ( n  = 10) interventions ( p  < 0.001), whereas daily water intake increased from 538 to 1990 ml in the fibre/water group ( p  < 0.001). Weekly bowel movements increased similarly in both interventions (fibre: 6.8-8.8; fibre/water: 8.6-10;  p  < 0.01), while faecal weight (71-126 g;  p  = 0.009) increased in the fibre/water group. This group showed higher counts of faecal  Bacteroides  and  Prevotella ,  Faecalibacterium prausnitzii , and  Bifidobacterium , whereas both interventions decreased the count of  Desulfovibrio . Transient abdominal symptoms occurred less frequently in the fibre/water than in the fibre group (3 vs. 9 participants;  p  = 0.020). In healthy, low-habitual fibre consumers, short-term water intake helps the intestinal adaptation to fibre supplementation. CLINICAL TRIAL REGISTRATION NUMBER:  NCT02838849.",2022,"This group showed higher counts of faecal  Bacteroides  and  Prevotella ,  Faecalibacterium prausnitzii , and  Bifidobacterium , whereas both interventions decreased the count of  Desulfovibrio .","['20 healthy, low-habitual fibre consumers', 'healthy, low-habitual fibre consumers']","['water intake in fibre supplementation', 'fibre supplementation with wheat bran, pectin, and green banana flour']","['Weekly bowel movements', 'Transient abdominal symptoms', 'daily water intake', 'faecal weight', 'higher counts of faecal  Bacteroides  and  Prevotella ,  Faecalibacterium prausnitzii , and  Bifidobacterium', 'count of  Desulfovibrio ', 'fibre intake']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]","[{'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0043138', 'cui_str': 'Wheat bran'}, {'cui': 'C0030744', 'cui_str': 'Pectin'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0016260', 'cui_str': 'Flour'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C0317558', 'cui_str': 'Faecalibacterium prausnitzii'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0011731', 'cui_str': 'Desulfovibrio'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",20.0,0.100616,"This group showed higher counts of faecal  Bacteroides  and  Prevotella ,  Faecalibacterium prausnitzii , and  Bifidobacterium , whereas both interventions decreased the count of  Desulfovibrio .","[{'ForeName': 'Gissele V R', 'Initials': 'GVR', 'LastName': 'Gonçalves', 'Affiliation': 'Programa de Pós-Graduação: Ciências em Gastroenterologia e Hepatologia, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Raíssa', 'Initials': 'R', 'LastName': 'Canova', 'Affiliation': 'Laboratório de Microbiologia e Imunologia Avançada, e Programa de Pós-Graduação em Bioexperimentação, Faculdade de Agronomia e Medicina Veterinária, Universidade de Passo Fundo (UPF), Passo Fundo, Brazil.'}, {'ForeName': 'Sidia M', 'Initials': 'SM', 'LastName': 'Callegari-Jacques', 'Affiliation': 'Departamento de Estatística, Instituto de Matemática e Estatística, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Frandoloso', 'Affiliation': 'Laboratório de Microbiologia e Imunologia Avançada, e Programa de Pós-Graduação em Bioexperimentação, Faculdade de Agronomia e Medicina Veterinária, Universidade de Passo Fundo (UPF), Passo Fundo, Brazil.'}, {'ForeName': 'Luiz C', 'Initials': 'LC', 'LastName': 'Kreutz', 'Affiliation': 'Laboratório de Microbiologia e Imunologia Avançada, e Programa de Pós-Graduação em Bioexperimentação, Faculdade de Agronomia e Medicina Veterinária, Universidade de Passo Fundo (UPF), Passo Fundo, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Fornari', 'Affiliation': 'Programa de Pós-Graduação: Ciências em Gastroenterologia e Hepatologia, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2022.2079117']
1154,35603451,Can caffeine supplementation reverse the impact of time of day on cognitive and short-term high intensity performances in young female handball players?,"ABBREVIATIONS


CAF: Caffeine PLC: Placebo SRT: Simple Reaction Time AT: Attention Test SJ: Squat Jump IAT: Illinois Agility Test OT: Oral Temperature QUEST: Questionnaire RPE: Rating of Perceived Exertion PD: Peak Distance TD: Total Distance.",2022,Placebo SRT: Simple Reaction Time AT: Attention Test SJ: Squat Jump IAT: Illinois Agility Test OT: Oral Temperature QUEST: Questionnaire RPE: Rating of Perceived Exertion PD: Peak Distance TD: Total Distance.,['young female handball players'],"['Placebo SRT', 'CAF: Caffeine PLC']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336936', 'cui_str': 'Handball'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]",[],,0.0891921,Placebo SRT: Simple Reaction Time AT: Attention Test SJ: Squat Jump IAT: Illinois Agility Test OT: Oral Temperature QUEST: Questionnaire RPE: Rating of Perceived Exertion PD: Peak Distance TD: Total Distance.,"[{'ForeName': 'Houda', 'Initials': 'H', 'LastName': 'Bougrine', 'Affiliation': 'Physical Activity Research Unit, Sport and Health (UR18JS01), National Observatory of Sports, Tunisia.'}, {'ForeName': 'Moncef', 'Initials': 'M', 'LastName': 'Cherif', 'Affiliation': 'High Institute of Sport and Physical Education Ksar-Saïd, Manouba University, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': 'Physical Activity Research Unit, Sport and Health (UR18JS01), National Observatory of Sports, Tunisia.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Souissi', 'Affiliation': 'Physical Activity Research Unit, Sport and Health (UR18JS01), National Observatory of Sports, Tunisia.'}]",Chronobiology international,['10.1080/07420528.2022.2077747']
1155,35607441,Effects of Individualized Nursing Based on Zero-Defect Theory on Perioperative Patients Undergoing Laparoscopic Cholecystectomy.,"Objective


This study is aimed at analyzing the effects of individualized nursing based on the zero-defect theory on perioperative patients undergoing laparoscopic cholecystectomy.
Methods


174 patients who underwent laparoscopic cholecystectomy from 1st November 2019 to 30th November 2020 were enrolled as the research subjects and randomly divided into control and observation groups. The patients in the control group received conventional perioperative nursing care, and the patients in the observation group were treated with individualized nursing based on the zero-defect theory.
Results


The heart rate, diastolic blood pressure, and systolic blood pressure level of patients in two groups after nursing decreased significantly, and the reduction in the observation group was more significant than that in the control group. The depression and anxiety scores of the two groups after nursing were decreased, and the decrease in the observation group was significantly greater than that in the control group. The time to first postoperative exhaust, return to normal intake, out-of-bed activity, and hospital stay in the observation group was less than that in the control group. The incidence of postoperative complications in the observation group was substantially lower than that in the control group. The satisfaction degree of nursing care in the observation group was significantly higher than that in the control group.
Conclusion


Individualized nursing care based on zero-defect theory can effectively reduce the perioperative psychological stress response of patients with laparoscopic cholecystectomy. It helps to improve the negative emotions of depression and anxiety, promotes the recovery of disease, reduces postoperative complications, and improves nursing satisfaction, which is worthy of clinical promotion.",2022,"The heart rate, diastolic blood pressure, and systolic blood pressure level of patients in two groups after nursing decreased significantly, and the reduction in the observation group was more significant than that in the control group.","['perioperative patients undergoing laparoscopic cholecystectomy', 'patients with laparoscopic cholecystectomy', '174 patients who underwent laparoscopic cholecystectomy from 1st November 2019 to 30th November 2020 were enrolled as the research subjects', 'Perioperative Patients Undergoing Laparoscopic Cholecystectomy']","['individualized nursing', 'individualized nursing based on the zero-defect theory', 'Individualized Nursing', 'conventional perioperative nursing care']","['depression and anxiety scores', 'satisfaction degree of nursing care', 'nursing satisfaction', 'perioperative psychological stress response', 'heart rate, diastolic blood pressure, and systolic blood pressure level', 'incidence of postoperative complications', 'time to first postoperative exhaust, return to normal intake, out-of-bed activity, and hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038931', 'cui_str': 'Nursing, Perioperative'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",174.0,0.00993785,"The heart rate, diastolic blood pressure, and systolic blood pressure level of patients in two groups after nursing decreased significantly, and the reduction in the observation group was more significant than that in the control group.","[{'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Department of Hepatobiliary Surgery, Huizhou Municipal Central Hospital, Huizhou, 516001 Guangdong, China.'}, {'ForeName': 'Xiaozheng', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Hepatobiliary Surgery, Huizhou Municipal Central Hospital, Huizhou, 516001 Guangdong, China.'}, {'ForeName': 'Bili', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': 'Department of Hepatobiliary Surgery, Huizhou Municipal Central Hospital, Huizhou, 516001 Guangdong, China.'}, {'ForeName': 'Huizhen', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatobiliary Surgery, Huizhou Municipal Central Hospital, Huizhou, 516001 Guangdong, China.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatobiliary Surgery, Huizhou Municipal Central Hospital, Huizhou, 516001 Guangdong, China.'}]",Disease markers,['10.1155/2022/5086350']
1156,35590054,Use of ziv-aflibercept in diabetic macular edema in a Ghanaian population.,"AIM


To investigate the use of intravitreal ziv-aflibercept (IVZ) in Ghanaian patients with diabetic macular edema (DME).
METHODS


A retrospective study of patients with DME, who had been treated with IVZ (1.25 mg/0.05 ml), as part of routine clinical practice, on pro re nata basis between 2016 and 2018 who had a minimum follow-up of 6 months was retrieved and analyzed. The primary outcome measure was change in best-corrected visual acuity (BCVA) at 6 months. Secondary outcome measures are change in BCVA at 12 months and at the last follow-up visit, adverse events and change in central macular thickness (CMT).
RESULTS


Twenty-five eyes of 17 patients (11 males) were included in this study. Their mean age was 60.82 ± 7.70 years and the mean duration of follow-up was 9.52 ± 3.31 months. The mean baseline BCVA (logMAR) of 0.65 ± 0.3 improved to 0.34 ± 0.16 (p < 0.0001) and 0.22 ± 0.15 (p = 0.0004) at 6 and 12 months, respectively. Twelve (48%) eyes had a visual gain of at least three lines at 6 months and 4 of 12 eyes (33.3%) at 1 year. There was a significant reduction in the mean CMT at 6 and 12 months and at the last follow-up visit compared to baseline (p < 0.0001). The adverse events recorded were raised intraocular pressure (four eyes) at 3, 6, and 12 months post injection, increased blood pressure in a patient with known systemic hypertension and transient memory loss in one patient.
CONCLUSION


IVZ (1.25 mg) was associated with significant improvement in BCVA and reduction in CMT at 6 and 12 months in eyes with DME. A randomized clinical trial is warranted to assess this potentially cost-effective intervention for DME in low-resource settings.",2022,There was a significant reduction in the mean CMT at 6 and 12 months and at the last follow-up visit compared to baseline (p < 0.0001).,"['patients with DME, who had been treated with IVZ (1.25\u2009mg/0.05\u2009ml), as part of routine clinical practice, on pro re nata basis between 2016 and 2018 who had a minimum follow-up of 6 months was retrieved and analyzed', 'Twenty-five eyes of 17 patients (11 males', 'Ghanaian patients with diabetic macular edema (DME', 'diabetic macular edema in a Ghanaian population', 'Their mean age was 60.82\u2009±\u20097.70 years and the mean duration of follow-up was 9.52\u2009±\u20093.31 months']","['ziv-aflibercept', 'intravitreal ziv-aflibercept (IVZ', 'IVZ']","['change in best-corrected visual acuity (BCVA', 'blood pressure', 'mean baseline BCVA (logMAR', 'mean CMT', 'change in BCVA at 12 months and at the last follow-up visit, adverse events and change in central macular thickness (CMT', 'visual gain', 'BCVA and reduction in CMT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C3485619', 'cui_str': 'ziv-aflibercept'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C3485619', 'cui_str': 'ziv-aflibercept'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.168671,There was a significant reduction in the mean CMT at 6 and 12 months and at the last follow-up visit compared to baseline (p < 0.0001).,"[{'ForeName': 'Imoro Zeba', 'Initials': 'IZ', 'LastName': 'Braimah', 'Affiliation': 'Department of Surgery (Eye), School of Medicine and Dentistry, Korle-Bu, Ghana. zebaimoro2000@yahoo.com.'}, {'ForeName': 'Winfried M', 'Initials': 'WM', 'LastName': 'Amoaku', 'Affiliation': 'Academic Ophthalmology, DCN, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK. winfried.amoaku@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-022-02005-6']
1157,35590052,"Developing comic strips promoting diabetic retinopathy screening in Kilimanjaro, Tanzania, using Intervention Mapping.","INTRODUCTION


Intervention Mapping is the protocol used by the Kilimanjaro Diabetic Programme to plan, develop, implement, and evaluate an evidence-based screening programme for diabetic retinopathy. Two comic strips were developed to deliver the message on the need for diabetic retinopathy screening.
OBJECTIVES


The first objective was to develop a culturally appropriate and accessible health message to promote diabetic retinopathy screening for the target audience. The second objective was to deliver a motivational message to promote acceptance of diabetic retinopathy screening irrespective of past eye health behaviour.
METHODS


A multi-method research design was used. Social cognitive theory provided the theoretical basis for the intervention, involving community participation to promote positive eye health behaviour.
RESULTS


For the Draughts Comic Strip, Flesch-Kincaid readability was 75.7% and comprehension was 87.04%, and for the Soap Opera Comic Strip Flesch-Kincaid readability was 75.6% and comprehension was 86.54%.
CONCLUSION


The development of the diabetic retinopathy comic strips was a positive health education strategy implemented during a clinical trial comparing methods of screening for diabetic retinopathy at the Kilimanjaro Christian Medical Centre Hospital. The level of comprehension of the comic strips by stakeholders indicated their understanding of the message. Patients enroled in the clinical trial requested the comic strips. No discarded comic strips were found in the clinic during the clinical trial.
TRIAL REGISTRATION


Trial registration number: ISRCTN31439939. Details available at https://www.isrctn.com/ .",2022,"For the Draughts Comic Strip, Flesch-Kincaid readability was 75.7% and comprehension was 87.04%, and for the Soap Opera Comic Strip Flesch-Kincaid readability was 75.6% and comprehension was 86.54%.
",[],[],[],[],[],[],2.0,0.0444692,"For the Draughts Comic Strip, Flesch-Kincaid readability was 75.7% and comprehension was 87.04%, and for the Soap Opera Comic Strip Flesch-Kincaid readability was 75.6% and comprehension was 86.54%.
","[{'ForeName': 'Claudette E', 'Initials': 'CE', 'LastName': 'Hall', 'Affiliation': 'Maastricht University, Faculty of Psychology and Neuroscience, Department of Work & Social Psychology, P.O. Box 616, MD, Maastricht, 6200, The Netherlands. claudetteghall@gmail.com.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'Hall', 'Affiliation': 'Newcastle Eye Hospital Research Foundation, Waratah, NSW, 2292, Australia.'}, {'ForeName': 'Joyse', 'Initials': 'J', 'LastName': 'Mallya', 'Affiliation': 'Kilimanjaro Centre for Community Ophthalmology, P.O. Box 2254, Moshi, Tanzania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Courtright', 'Affiliation': 'University of Cape Town, Division of Ophthalmology, Groote Schuur Hospital, Observatory, Cape Town, 7925, RSA.'}, {'ForeName': 'Gerjo', 'Initials': 'G', 'LastName': 'Kok', 'Affiliation': 'Maastricht University, Faculty of Psychology and Neuroscience, Department of Work & Social Psychology, P.O. Box 616, MD, Maastricht, 6200, The Netherlands.'}]","Eye (London, England)",['10.1038/s41433-022-02003-8']
1158,35595645,Lack of muscle stem cell proliferation and myocellular hypertrophy in sIBM patients following blood-flow restricted resistance training.,"Sporadic inclusion body myositis (sIBM) is characterised by skeletal muscle inflammation, progressive muscle loss and weakness, which is largely refractory to immunosuppressive treatment. Low-load blood-flow restricted (BFR) training has been shown to evoke gains in myofibre cross sectional area (mCSA) in healthy adults. This could partially be due to the activation and integration of muscle satellite cells (SC) resulting in myonuclei addition. Consequently, this study investigated the effect of 12-weeks lower limb low-load BFR resistance training in sIBM patients on SC and myonuclei content, myofibre size and capillarization. Muscle biopsies from sIBM patients randomised to 12-weeks of low-load BFR resistance training (n = 11) or non-exercising controls (CON) (n = 9) were analysed for SC and myonuclei content, myofibre size and capillarization using three-colour immunofluorescence microscopy and computerised quantification procedures. No between-group differences (time-by-group interactions) or within-groups changes were observed for resident SCs (Pax7 + /Six1 + ), proliferating SCs (Pax7 + / Ki67 + ), myonuclei (Six1 + ), type 1 mCSA or capillary number (CD31 + ). However, a time-by-group interaction for type 2 mCSA was observed (p = 0.04). Satellite cell content, myonuclei number, mCSA and capillary density remained unaffected following 12-weeks low-load BFR resistance training, indicating limited myogenic capacity and satellite cell plasticity in long-term sIBM patients.",2022,"Satellite cell content, myonuclei number, mCSA and capillary density remained unaffected following 12-weeks low-load BFR resistance training, indicating limited myogenic capacity and satellite cell plasticity in long-term sIBM patients.","['healthy adults', 'sIBM patients following blood-flow restricted resistance training', 'sIBM patients']","['12-weeks lower limb low-load BFR resistance training', 'low-load BFR resistance training (n\u202f=\u202f11) or non-exercising controls (CON', 'Low-load blood-flow restricted (BFR) training']","['resident SCs (Pax7 + /Six1 + ), proliferating SCs (Pax7 + / Ki67 + ), myonuclei (Six1 + ), type 1 mCSA or capillary number (CD31 + ', 'Satellite cell content, myonuclei number, mCSA and capillary density']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0751713', 'cui_str': 'Myopathy, Inclusion Body, Sporadic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0905893', 'cui_str': 'PAX7 protein, human'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0081939', 'cui_str': 'Lymphocyte antigen CD31'}, {'cui': 'C0205868', 'cui_str': 'Perineuronal satellite cell'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",9.0,0.0401004,"Satellite cell content, myonuclei number, mCSA and capillary density remained unaffected following 12-weeks low-load BFR resistance training, indicating limited myogenic capacity and satellite cell plasticity in long-term sIBM patients.","[{'ForeName': 'Kasper Yde', 'Initials': 'KY', 'LastName': 'Jensen', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Pathology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark. Electronic address: Kasper.yde.jensen@regionh.dk.'}, {'ForeName': 'Jakob Lindberg', 'Initials': 'JL', 'LastName': 'Nielsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Henrik Daa', 'Initials': 'HD', 'LastName': 'Schrøder', 'Affiliation': 'Department of Pathology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Pathology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Boyle', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Anders Nørkær', 'Initials': 'AN', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Rune Dueholm', 'Initials': 'RD', 'LastName': 'Bech', 'Affiliation': 'Department of Orthopaedics and Traumatology, Zealand University Hospital, Koege Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Frandsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aagaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Louise Pyndt', 'Initials': 'LP', 'LastName': 'Diederichsen', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Department of Rheumatology, Odense University Hospital, Odense, Denmark.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2022.04.006']
1159,35596546,Advancing Posttraumatic Stress Disorder Diagnosis and the Treatment of Trauma in Humanitarian Emergencies via Mobile Health: Protocol for a Proof-of-Concept Nonrandomized Controlled Trial.,"BACKGROUND


Decentralized health systems in low- and middle-income countries (LMICs) affected by humanitarian crises lack resources and a qualified workforce to attend to the overwhelming demand for mental health care in emergencies. Innovative approaches that are safe, cost-effective, and scalable are needed to address the burden of traumatic stress caused by emergencies. High mobile phone ownership rates combined with the precision of neural, cognitive, and biometric measures of trauma and their feasible integration with artificial intelligence makes digital app interventions a promising pathway to promote precision diagnosis and high-impact care.
OBJECTIVE


This study aimed to advance methods for the objective diagnosis and treatment of trauma in emergencies across LMICs by examining neural, cognitive, and biometric markers and the efficacy of the eResilience app, a neuroscience-informed mobile health mental health app intervention, via changes in clinical symptomatology, cognitive performance, and brain activity.
METHODS


Trauma-exposed African refugees residing in Australia were selected for this study. A research software version of the eResilience app with advanced monitoring capabilities was designed for this trial. Participants completed the eResilience app at home during a 7-day period. Clinical, cognitive, and electrophysiological data were collected at baseline, along with posttest measurements to examine biomarkers of trauma and the efficacy of the proposed digital intervention for the treatment of trauma and its potential outcomes, including depression, anxiety, physical symptoms, self-harm, substance misuse, and cognitive impairment. In addition, biofeedback, well-being, and subjective stress data points were collected via the app during the treatment week, followed by clinical interviews at 1, 3, 6, and 12 months after the intervention.
RESULTS


Data collection was conducted between 2018 and 2020. A total of 100 participants exposed to war were screened; 75 (75%) were enrolled and assigned to a trauma-exposed control (38/75, 51%) or posttraumatic stress disorder condition (37/75, 49%); and 70 (70%) completed all baseline, treatment, and posttest assessments. A total of 89% (62/70) of those who completed the intervention opted to enroll in the 3-, 6-, and 12-month follow-ups. Data collection is complete. As of May 2022, the results of all proposed analyses are being prepared for publication. If proven efficacious, this proof-of-concept clinical trial will inform fully powered randomized clinical trials in LMICs to further develop artificial intelligence-powered, app-based diagnostic and prognostic features and determine the app's cross-cultural efficacy for the treatment of trauma in emergency settings.
CONCLUSIONS


This protocol provides researchers with a comprehensive background of the study rationale, a detailed guideline for replication studies interested in examining the feasibility and efficacy of the eResilience app across varied demographics, and a robust framework for investigating low-cost objective diagnostic markers in mental health interventions. Methodological limitations and suggestions are also provided.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12616001205426; https://tinyurl.com/yckwc4d7.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/38223.",2022,"High mobile phone ownership rates combined with the precision of neural, cognitive, and biometric measures of trauma and its feasible integration with Artificial Intelligence (AI) makes digital application (app) interventions a promising pathway to promote precision diagnosis and high-impact care.
","['Trauma-exposed African refugees residing in Australia', 'A total n=100 participants exposed to war were screened, n= 75 were enrolled and assigned to a trauma-exposed control (n=38) or Posttraumatic Stress Disorder (PTSD) condition (n=37), and n= 70 completed all baseline, treatment, and post-test assessments', 'A total n=62 of the n=70 who completed the intervention opted to enrol in the 3, 6 and 12-month follow-ups']","['Artificial Intelligence (AI', 'ANZCTR']","['Clinical, cognitive, and electrophysiological data', 'depression, anxiety, physical symptoms, self-harm, substance misuse, and cognitive impairment', 'biofeedback, wellbeing, and subjective stress data points']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",100.0,0.213898,"High mobile phone ownership rates combined with the precision of neural, cognitive, and biometric measures of trauma and its feasible integration with Artificial Intelligence (AI) makes digital application (app) interventions a promising pathway to promote precision diagnosis and high-impact care.
","[{'ForeName': 'Janaina V', 'Initials': 'JV', 'LastName': 'Pinto', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'School of Psychology, Faculty of Science, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': ""O'Toole"", 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}]",JMIR research protocols,['10.2196/38223']
1160,35597311,Airway strategy and ventilation rates in the pragmatic airway resuscitation trial.,"BACKGROUND


We sought to describe ventilation rates during out-of-hospital cardiac arrest (OHCA) resuscitation and their associations with airway management strategy and outcomes.
METHODS


We analyzed continuous end-tidal carbon dioxide capnography data from adult OHCA enrolled in the Pragmatic Airway Resuscitation Trial (PART). Using automated signal processing techniques, we determined continuous ventilation rates for consecutive 10-second epochs after airway insertion. We defined hypoventilation as a ventilation rate < 6 breaths/min. We defined hyperventilation as a ventilation rate > 12 breaths/min. We compared differences in total and percentage post-airway hyper- and hypoventilation between airway interventions (laryngeal tube (LT) vs. endotracheal intubation (ETI)). We also determined associations between hypo-/hyperventilation and OHCA outcomes (ROSC, 72-hour survival, hospital survival, hospital survival with favorable neurologic status).
RESULTS


Adequate post-airway capnography were available for 1,010 (LT n = 714, ETI n = 296) of 3,004 patients. Median ventilation rates were: LT 8.0 (IQR 6.5-9.6) breaths/min, ETI 7.9 (6.5-9.7) breaths/min. Total duration and percentage of post-airway time with hypoventilation were similar between LT and ETI: median 1.8 vs. 1.7 minutes, p = 0.94; median 10.5% vs. 11.5%, p = 0.60. Total duration and percentage of post-airway time with hyperventilation were similar between LT and ETI: median 0.4 vs. 0.4 minutes, p = 0.91; median 2.1% vs. 1.9%, p = 0.99. Hypo- and hyperventilation exhibited limited associations with OHCA outcomes.
CONCLUSION


In the PART Trial, EMS personnel delivered post-airway ventilations at rates satisfying international guidelines, with only limited hypo- or hyperventilation. Hypo- and hyperventilation durations did not differ between airway management strategy and exhibited uncertain associations with OCHA outcomes.",2022,"Total duration and percentage of post-airway time with hyperventilation were similar between LT and ETI: median 0.4 vs. 0.4 minutes, p=0.91; median 2.1% vs. 1.9%, p=0.99.",['adult OHCA enrolled in the Pragmatic Airway Resuscitation Trial (PART'],['airway interventions (laryngeal tube (LT) vs. endotracheal intubation (ETI'],"['Hypo- and hyperventilation durations', 'ventilation rates', 'Airway Strategy and Ventilation Rates', 'hypo-/hyperventilation and OHCA outcomes (ROSC, 72-hour survival, hospital survival, hospital survival with favorable neurologic status', 'continuous ventilation rate', 'Total duration and percentage of post-airway time with hypoventilation', 'Median ventilation rates', 'Total duration and percentage of post-airway time with hyperventilation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0746866', 'cui_str': 'Neurological status'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3203358', 'cui_str': 'Hypoventilation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",3004.0,0.0403199,"Total duration and percentage of post-airway time with hyperventilation were similar between LT and ETI: median 0.4 vs. 0.4 minutes, p=0.91; median 2.1% vs. 1.9%, p=0.99.","[{'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Wang', 'Affiliation': 'The Ohio State University, United States. Electronic address: henry.wang@osumc.edu.'}, {'ForeName': 'Xabier', 'Initials': 'X', 'LastName': 'Jaureguibeitia', 'Affiliation': 'University of the Basque Country, Spain. Electronic address: xabier.jaureguibeitia@ehu.eus.'}, {'ForeName': 'Elisabete', 'Initials': 'E', 'LastName': 'Aramendi', 'Affiliation': 'University of the Basque Country, Spain. Electronic address: elisabete.aramendi@ehu.eus.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington, United States. Electronic address: nichol@uw.edu.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States. Electronic address: TAufderh@mcw.edu.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health and Science University, United States. Electronic address: dayam@ohsu.edu.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health and Science University, United States. Electronic address: hansemat@ohsu.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Nassal', 'Affiliation': 'The Ohio State University, United States. Electronic address: Michelle.Nassal@osumc.edu.'}, {'ForeName': 'Ashish R', 'Initials': 'AR', 'LastName': 'Panchal', 'Affiliation': 'The Ohio State University, United States. Electronic address: Ashish.Panchal@osumc.edu.'}, {'ForeName': 'Dhimitri A', 'Initials': 'DA', 'LastName': 'Nikolla', 'Affiliation': 'Allegheny Health Network - Saint Vincent, United States.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Alonso', 'Affiliation': 'University of the Basque Country, Spain. Electronic address: erik.alonso@ehu.es.'}, {'ForeName': 'Jestin', 'Initials': 'J', 'LastName': 'Carlson', 'Affiliation': 'University of Pittsburgh, United States. Electronic address: jcarlson@ahn-emp.com.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington, United States. Electronic address: rschmick@uw.edu.'}, {'ForeName': 'Shannon W', 'Initials': 'SW', 'LastName': 'Stephens', 'Affiliation': 'University of Alabama at Birmingham, United States. Electronic address: swstephens@uabmc.edu.'}, {'ForeName': 'Unai', 'Initials': 'U', 'LastName': 'Irusta', 'Affiliation': 'University of the Basque Country, Spain.'}, {'ForeName': 'Ahamed', 'Initials': 'A', 'LastName': 'Idris', 'Affiliation': 'University of Texas Southwestern Medical Center, United States. Electronic address: Ahamed.Idris@utsouthwestern.edu.'}]",Resuscitation,['10.1016/j.resuscitation.2022.05.008']
1161,35598698,Associations between the timing of eating and weight-loss in calorically restricted healthy adults: Findings from the CALERIE study.,"Calorie restriction (CR) and time-restricted eating (TRE) are distinctly different dietary management strategies with overlapping health outcomes. After two years of CR, healthy participants in the Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE) study showed significant weight-loss relative to the ad libitum intake control group and achieved 12% CR on average. Preclinical rodent studies have shown that sustaining a consistent eating interval of 8-12 h between the first and last calories of each day-without reducing daily calorie intake-can impart health benefits that partly overlap with those imparted by CR. Preclinical CR protocols often inadvertently restrict eating interval, and conversely, clinical studies of TRE often inadvertently result in modest CR. Other factors related to daily timing of food intake, such as breakfast skipping, and early food intake also impact health outcomes. These observations have raised the possibility that CR protocols can be further optimized by adopting relevant aspects of eating patterns to boost weight loss and health outcomes. With a goal to inform CR protocols that aim to optimize eating patterns, the objective of this secondary analysis was to test aspects of daily timing of food intake associated with greater weight loss in the CALERIE study participants. We found no difference in the daily time window of energy intake between the CR and control arms. In the CALERIE trial, weight change was used as a proxy for adherence to CR, and hence we used linear models to test the relationships among CR, weight loss, and temporal aspects of daily eating pattern. We found that CR alone could explain 41% of the variance in weight loss. We tested the contribution of eating interval, time to 50% daily calorie intake, and day-to-day shifts in the time of the first (breakfast) or last meal consumed. We found that eating interval and variation in the timing of the first and last meals significantly influenced weight loss after controlling for CR. Our models suggest that shorter eating intervals are associated with greater CR (1% of the variance explained) and facilitate additional weight loss. Our models suggest that less day to day variation in first mealtime is directly associated with weight loss (6% of the variance explained). More regular first meal timing is also associated with greater CR (2% of the variance explained). Likewise, regular timing of the last daily meal is directly associated with weight loss (1% of the variance explained) and greater CR (1% of the variance explained). The time to 50% of daily calorie intake or consuming half the caloric intake earlier in the day is associated with additional CR (2% of the variance explained). In summary, these secondary analyses on CALERIE data suggest that - in order to maximize CR and weight loss - future CR protocols should encourage participants to adopt consistent timing of their first and last meals, a shorter eating window, and earlier consumption of food.",2022,More regular first meal timing is also associated with greater CR (2% of the variance explained).,['calorically restricted healthy adults'],['CR'],"['Calorie restriction (CR) and time-restricted eating (TRE', 'weight loss', 'daily time window of energy intake', 'weight-loss relative']","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0413428,More regular first meal timing is also associated with greater CR (2% of the variance explained).,"[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Fleischer', 'Affiliation': 'Department of Cognitive Science, University of California San Diego, La Jolla, CA, USA. Electronic address: jfleischer@ucsd.edu.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA. Electronic address: sai.das@tufts.edu.'}, {'ForeName': 'Manjushri', 'Initials': 'M', 'LastName': 'Bhapkar', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA. Electronic address: manjushri.bhapkar@duke.edu.'}, {'ForeName': 'Emily N C', 'Initials': 'ENC', 'LastName': 'Manoogian', 'Affiliation': 'Salk Institute for Biological Studies, 10010, N. Torrey Pines Road, La Jolla, CA, USA. Electronic address: emily.manoogian@salk.edu.'}, {'ForeName': 'Satchidananda', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Salk Institute for Biological Studies, 10010, N. Torrey Pines Road, La Jolla, CA, USA. Electronic address: satchin@salk.edu.'}]",Experimental gerontology,['10.1016/j.exger.2022.111837']
1162,35604803,Cost-effectiveness of an educational intervention to reduce potentially inappropriate medication.,"BACKGROUND


Educational interventions can reduce potentially inappropriate medication (PIM) use in older people. Their effectiveness has been measured mainly as changes in PIM use. In this economic evaluation, we analyse the impact of an educational intervention in terms of costs and quality-adjusted life years (QALYs).
METHODS


The educational intervention consisted of activating and interactive training sessions for nursing staff and consulting physicians, and was compared with treatment as usual (TAU). Participants (n = 227) in a cluster randomised trial (cRCT) were residents living permanently in assisted living facilities (n = 20 wards). For economic evaluation, participants' healthcare service use costs and costs for the intervention were estimated for a 12 month period.Incremental cost-effectiveness ratios (ICERs) were estimated for QALYs per participant. Cost-effectiveness analysis was conducted from a healthcare perspective. A bootstrapped cost-effectiveness plane and one-way sensitivity analysis were undertaken to analyse the uncertainty surrounding the estimates.
RESULTS


The educational intervention was estimated to be less costly and less effective in terms of QALYs than TAU at the 12 month follow-up [incremental costs -€1,629, confidence interval (CI) -€5,489 to €2,240; incremental effect -0.02, CI -0.06 to 0.02]. The base case ICER was >€80,000/QALY.
CONCLUSION


The educational intervention was estimated to be less costly and less effective in terms of QALYs compared with TAU, but the results are subject to some uncertainties. Reduction in PIM use or benefits in quality of life did not seem to translate into improvements in QALYs. Our findings emphasise the need for better understanding of the impact of decreasing PIM use on health outcomes.",2022,"The educational intervention was estimated to be less costly and less effective in terms of QALYs than TAU at the 12 month follow-up [incremental costs -€1,629, confidence interval (CI) -€5,489 to €2,240; incremental effect","['older people', 'Participants (n\u2009=\u2009227) in a cluster randomised trial (cRCT) were residents living permanently in assisted living facilities (n\u2009=\u200920 wards']","['educational intervention', 'educational intervention consisted of activating and interactive training sessions']","['Incremental cost-effectiveness ratios (ICERs', 'costs and quality-adjusted life years (QALYs', 'Cost-effectiveness']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0241769,"The educational intervention was estimated to be less costly and less effective in terms of QALYs than TAU at the 12 month follow-up [incremental costs -€1,629, confidence interval (CI) -€5,489 to €2,240; incremental effect","[{'ForeName': 'Mervi', 'Initials': 'M', 'LastName': 'Rantsi', 'Affiliation': 'Department of Health and Social Management, University of Eastern Finland, Kuopio 70211, Finland.'}, {'ForeName': 'Kaisu H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Department of General Practice, University of Helsinki, Helsinki 00014, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice, University of Helsinki, Helsinki 00014, Finland.'}, {'ForeName': 'Virva', 'Initials': 'V', 'LastName': 'Hyttinen', 'Affiliation': 'Department of Health and Social Management, University of Eastern Finland, Kuopio 70211, Finland.'}, {'ForeName': 'Eila', 'Initials': 'E', 'LastName': 'Kankaanpää', 'Affiliation': 'Department of Health and Social Management, University of Eastern Finland, Kuopio 70211, Finland.'}]",Age and ageing,['10.1093/ageing/afac112']
1163,35604789,Implicit Racial-Ethnic and Insurance-Mediated Bias to Recommending Diabetes Technology: Insights from T1D Exchange Multicenter Pediatric and Adult Diabetes Provider Cohort.,"Background:  Despite documented benefits of diabetes technology in managing type 1 diabetes, inequities persist in the use of these devices. Provider bias may be a driver of inequities, but the evidence is limited. Therefore, we aimed to examine the role of race/ethnicity and insurance-mediated provider implicit bias in recommending diabetes technology.  Method:  We recruited 109 adult and pediatric diabetes providers across 7 U.S. endocrinology centers to complete an implicit bias assessment composed of a clinical vignette and ranking exercise. Providers were randomized to receive clinical vignettes with differing insurance and patient names as proxy for Racial-Ethnic identity. Bias was identified if providers: (1) recommended more technology for patients with an English name (Racial-Ethnic bias) or private insurance (insurance bias), or (2) Race/Ethnicity or insurance was ranked high (Racial-Ethnic and insurance bias, respectively) in recommending diabetes technology. Provider characteristics were analyzed using descriptive statistics and multivariate logistic regression.  Result:  Insurance-mediated implicit bias was common in our cohort ( n  = 66, 61%). Providers who were identified to have insurance-mediated bias had greater years in practice (5.3 ± 5.3 years vs. 9.3 ± 9 years,  P  = 0.006). Racial-Ethnic-mediated implicit bias was also observed in our study ( n  = 37, 34%). Compared with those without Racial-Ethnic bias, providers with Racial-Ethnic bias were more likely to state that they could recognize their own implicit bias (89% vs. 61%,  P  = 0.001).  Conclusion:  Provider implicit bias to recommend diabetes technology was observed based on insurance and Race/Ethnicity in our pediatric and adult diabetes provider cohort. These data raise the need to address provider implicit bias in diabetes care.",2022,"Providers who were identified to have insurance-mediated bias had greater years in practice (5.3±5.3 years vs. 9.3±9 years, p=0.006).","['one hundred and nine adult and pediatric diabetes providers across seven US endocrinology centers to complete an implicit bias assessment comprised of a clinical vignette and ranking exercise', 'patients with an English name (Racial-Ethnic bias) or private insurance (insurance bias), or 2) Race-Ethnicity or insurance was ranked high (Racial-Ethnic and insurance bias, respectively) in recommending diabetes technology']",['clinical vignettes with differing insurance and patient names as proxy for Racial-Ethnic identity'],[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C1299487', 'cui_str': 'Patient name'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}]",[],109.0,0.134072,"Providers who were identified to have insurance-mediated bias had greater years in practice (5.3±5.3 years vs. 9.3±9 years, p=0.006).","[{'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Odugbesan', 'Affiliation': 'T1D Exchange, QI & Population Health Department, Boston, Massachusetts, USA.'}, {'ForeName': 'Ananta', 'Initials': 'A', 'LastName': 'Addala', 'Affiliation': ""Stanford University, Division of Pediatric Endocrinology & Diabetes, Lucile Packard Children's Hospital, Stanford, California, USA.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Nelson', 'Affiliation': ""Le Bonheur Children's Hospital, Pediatric Endocrinology, Memphis, Tennessee, USA.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hopkins', 'Affiliation': 'SUNY Upstate Medical Center, Division of Endocrinology and Metabolism, Syracuse, New York, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Cossen', 'Affiliation': ""Children's Healthcare of Atlanta, Division of Pediatric Endocrinology, Atlanta, Georgia, USA.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schmitt', 'Affiliation': 'The University of Alabama Pediatric Endocrinology and Diabetes at Birmingham Hospital, Birmingham, Alabama, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Indyk', 'Affiliation': 'Nationwide Children Hospital, Division of Endocrinology, Columbus, Ohio, USA.'}, {'ForeName': 'Nana-Hawa Yayah', 'Initials': 'NY', 'LastName': 'Jones', 'Affiliation': ""Cincinnati Children's Hospital, Division of Endocrinology, Cincinnati, Ohio, USA.""}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Yeshiva University Albert Einstein College of Medicine, Division of Endocrinology, Bronx, New York, USA.'}, {'ForeName': 'Saketh', 'Initials': 'S', 'LastName': 'Rompicherla', 'Affiliation': 'T1D Exchange, QI & Population Health Department, Boston, Massachusetts, USA.'}, {'ForeName': 'Osagie', 'Initials': 'O', 'LastName': 'Ebekozien', 'Affiliation': 'T1D Exchange, QI & Population Health Department, Boston, Massachusetts, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2022.0042']
1164,35604760,Adolescent Health Promotion Interventions Using Well-Care Visits and a Smartphone Cognitive Behavioral Therapy App: Randomized Controlled Trial.,"BACKGROUND


Adolescent health promotion is important in preventing risk behaviors and improving mental health. Health promotion during adolescence has been shown to contribute to the prevention of late onset of the mental health disease. However, scalable interventions have not been established yet.
OBJECTIVE


This study was designed to test the efficacy of two adolescent health promotion interventions: a well-care visit (WCV) with a risk assessment interview and counseling and self-monitoring with a smartphone cognitive behavioral therapy (CBT) app. Our hypothesis was that participants who had received both WCV and the CBT app would have better outcomes than those who had received only WCV or those who had not received any intervention. We conducted a prospective multi-institutional randomized controlled trial.
METHODS


Participants were 217 adolescents aged 13-18 years. They were randomly divided into two intervention groups (WCV group and WCV with CBT app group) and a nonintervention group. WCV comprised a standardized physical examination along with a structured interview and counseling for youth risk assessment, which was designed with reference to the Guideline for Health Supervision of Adolescents of Bright Futures. A smartphone-based CBT program was developed based on the CBT approach. The CBT app comprised a 1-week psychoeducation component and a 1-week self-monitoring component. During the CBT program, participants created several self-monitoring sheets based on the CBT model with five window panels: event, thoughts, feelings, body response, and actions. The primary outcome was the change in scores for depressive symptoms. Secondary outcomes included changes in scores for self-esteem, quality of life, self-monitoring, and an adolescent health promotion scale. These outcomes were evaluated at baseline and at 1, 2, and 4 months after baseline. The exploratory outcome was the presence of suicidal ideation during the observation period. Intervention effects were estimated using mixed effect models.
RESULTS


In total, 94% (204/217) of the participants completed the 4-month evaluation. Both intervention groups showed a significant effect in the form of reduced scores for depressive symptoms at 1 month in high school students; however, these effects were not observed at 2 and 4 months. The intervention effect was significantly more predominant in those scoring above cutoff for depressive symptoms. There was significantly less suicidal ideation in the intervention groups. As for secondary outcomes, there was significant increase in health promotion scale scores at the 4-month follow-up among junior high school students in the WCV group. Moreover, the CBT app was significantly effective in terms of obtaining self-monitoring skills and reducing depressive symptoms.
CONCLUSIONS


Although adolescent health promotion interventions may have short-term benefits, the frequency of WCV and further revision of the CBT app should be considered to evaluate long-term effectiveness.
TRIAL REGISTRATION


University Hospital Medical Information Network Clinical Trials Registry UMIN 000036343; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041246.",2022,"Both intervention groups showed a significant effect in the form of reduced scores for depressive symptoms at 1 month in high school students; however, these effects were not observed at 2 and 4 months.",['Participants were 217 adolescents aged 13-18 years'],"['WCV', 'intervention groups (WCV group and WCV with CBT', 'care visit (WCV) with a risk assessment interview and counseling and self-monitoring with a smartphone cognitive behavioral therapy (CBT', 'CBT', 'adolescent health promotion interventions', 'Adolescent Health Promotion Interventions']","['change in scores for depressive symptoms', 'obtaining self-monitoring skills and reducing depressive symptoms', 'suicidal ideation', 'depressive symptoms', 'changes in scores for self-esteem, quality of life, self-monitoring, and an adolescent health promotion scale', 'health promotion scale scores']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0589044', 'cui_str': 'Self-monitoring skills'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}]",217.0,0.0198264,"Both intervention groups showed a significant effect in the form of reduced scores for depressive symptoms at 1 month in high school students; however, these effects were not observed at 2 and 4 months.","[{'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nagamitsu', 'Affiliation': 'Department of Pediatrics, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Kanie', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Sakashita', 'Affiliation': 'Department of Interdisciplinary Medicine, National Center for Child Health and Development, Setagaya, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Sakuta', 'Affiliation': 'Child Development and Psychosomatic Medicine Center, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Okada', 'Affiliation': 'Department of Pediatrics, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Kencho', 'Initials': 'K', 'LastName': 'Matsuura', 'Affiliation': 'Department of Nursing, Fukuoka Prefectural University, Tagawa, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Katayanagi', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Katayama', 'Affiliation': 'Life2Bits, Shibuya, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Otani', 'Affiliation': 'Child Development and Psychosomatic Medicine Center, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Kitajima', 'Affiliation': 'Child Development and Psychosomatic Medicine Center, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'Child Development and Psychosomatic Medicine Center, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Child Development and Psychosomatic Medicine Center, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Chie', 'Initials': 'C', 'LastName': 'Tanaka', 'Affiliation': 'Department of Pediatrics, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Fujii', 'Affiliation': 'Department of Pediatrics, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Shigeyasu', 'Affiliation': 'Department of Pediatrics, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Ishii', 'Affiliation': 'Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Sakai', 'Affiliation': 'Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Neuropsychiatry, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Tatsuyuki', 'Initials': 'T', 'LastName': 'Kakuma', 'Affiliation': 'Biostatistics Center, Kurume University, Kurume, Japan.'}, {'ForeName': 'Yushiro', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Horikoshi', 'Affiliation': 'National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Kodaira, Japan.'}]",JMIR mHealth and uHealth,['10.2196/34154']
1165,35606763,The effectiveness of the Structured Health Intervention For Truckers (SHIFT): a cluster randomised controlled trial (RCT).,"BACKGROUND


Long distance heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related co-morbidities, and are underserved in terms of health promotion initiatives. The purpose of this study was to evaluate the effectiveness of the multicomponent 'Structured Health Intervention For Truckers' (SHIFT), compared to usual care, at 6- and 16-18-month follow-up.
METHODS


We conducted a two-arm cluster RCT in transport sites throughout the Midlands, UK. Outcome measures were assessed at baseline, at 6- and 16-18-month follow-up. Clusters were randomised (1:1) following baseline measurements to either the SHIFT arm or usual practice control arm. The 6-month SHIFT programme included a group-based interactive 6-h education and behaviour change session, health coach support and equipment provision (Fitbit® and resistance bands/balls to facilitate a 'cab workout'). The primary outcome was device-assessed physical activity (mean steps/day) at 6 months. Secondary outcomes included the following: device-assessed sitting, physical activity intensity and sleep; cardiometabolic health, diet, mental wellbeing and work-related psychosocial variables. Data were analysed using mixed-effect linear regression models using a complete-case population.
RESULTS


Three hundred eighty-two HGV drivers (mean ± SD age: 48.4 ± 9.4 years, BMI: 30.4 ± 5.1 kg/m 2 , 99% male) were recruited across 25 clusters (sites) and randomised into either the SHIFT (12 clusters, n = 183) or control (13 clusters, n = 199) arms. At 6 months, 209 (55%) participants provided primary outcome data. Significant differences in mean daily steps were found between groups, in favour of the SHIFT arm (adjusted mean difference: 1008 steps/day, 95% CI: 145-1871, p = 0.022). Favourable differences were also seen in the SHIFT group, relative to the control group, in time spent sitting (- 24 mins/day, 95% CI: - 43 to - 6), and moderate-to-vigorous physical activity (6 mins/day, 95% CI: 0.3-11). Differences were not maintained at 16-18 months. No differences were observed between groups in the other secondary outcomes at either follow-up.
CONCLUSIONS


The SHIFT programme led to a potentially clinically meaningful difference in daily steps, between trial arms, at 6 months. Whilst the longer-term impact is unclear, the programme offers potential to be incorporated into driver training courses to promote activity in this at-risk, underserved and hard-to-reach essential occupational group.
TRIAL REGISTRATION


ISRCTN10483894 (date registered: 01/03/2017).",2022,"Significant differences in mean daily steps were found between groups, in favour of the SHIFT arm (adjusted mean difference: 1008 steps/day, 95% CI: 145-1871, p = 0.022).","['Three hundred eighty-two HGV drivers (mean\u2009±\u2009SD age: 48.4\u2009±\u20099.4\u2009years, BMI: 30.4\u2009±\u20095.1\u2009kg/m 2 , 99% male']","['SHIFT arm or usual practice control arm', ""SHIFT programme included a group-based interactive 6-h education and behaviour change session, health coach support and equipment provision (Fitbit® and resistance bands/balls to facilitate a 'cab workout"", ""multicomponent 'Structured Health Intervention For Truckers' (SHIFT"", 'Structured Health Intervention For Truckers (SHIFT']","['time spent sitting', 'device-assessed physical activity', 'moderate-to-vigorous physical activity', 'device-assessed sitting, physical activity intensity and sleep; cardiometabolic health, diet, mental wellbeing and work-related psychosocial variables', 'mean daily steps']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0403128', 'cui_str': 'Heavy goods vehicle driver'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",,0.1829,"Significant differences in mean daily steps were found between groups, in favour of the SHIFT arm (adjusted mean difference: 1008 steps/day, 95% CI: 145-1871, p = 0.022).","[{'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Clemes', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK. S.A.Clemes@lboro.ac.uk.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Varela-Mato', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Danielle H', 'Initials': 'DH', 'LastName': 'Bodicoat', 'Affiliation': 'Independent Researcher, Leicester, LE7 3SX, UK.'}, {'ForeName': 'Cassandra L', 'Initials': 'CL', 'LastName': 'Brookes', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, LE1 7RH, UK.'}, {'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Leicester, LE5 4PW, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, LE1 7RH, UK.'}, {'ForeName': 'Amber J', 'Initials': 'AJ', 'LastName': 'Guest', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Johnson', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, LE5 4PW, UK.'}, {'ForeName': 'Fehmidah', 'Initials': 'F', 'LastName': 'Munir', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Paine', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Ruettger', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Sayyah', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Sherry', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Ana Suazo', 'Initials': 'AS', 'LastName': 'Di Paola', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, LE1 7RH, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Troughton', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, LE5 4PW, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Leicester, LE5 4PW, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}]",BMC medicine,['10.1186/s12916-022-02372-7']
1166,35608567,Nutrition Intake and Nutrition Status of Pancreatic Cancer Patients: Cross-Sectional and Longitudinal Analysis of a Randomized Controlled Exercise Intervention Study.,"Pancreatic cancer patients often present with an inadequate nutritional intake. At the same time, there are no standardized recommendations for nutrition intake during and after cancer treatment. In a prospective analysis of a randomized controlled trial analyzing the effects of a 6-month resistance training in pancreatic cancer patients, we assessed the nutritional intake and the impact of a 6-month supervised resistance training or home-based resistance training vs. usual care control on the nutritional intake of the patients. Nutritional intake was assessed by 24-h recall before and after the 6-month resistance training period. At baseline low protein intake (<1 g/kg body weight) was found in 33.9% of the 59 patients and low energy intake (<25 kcal/kg body weight) was found in 39.0% of the patients. In all, 35.6% of the patients were classified with a risk of malnutrition (NRS ≥ 3). In the total of 46 patients who finished the 6-month intervention period, there was no difference in nutritional intake over time between resistance training and usual care control. In conclusion, it appears that the majority of our study population had an adequate protein and energy intake. A resistance training seems to have no influence on the nutritional intake of the patients.",2022,"In the total of 46 patients who finished the 6-month intervention period, there was no difference in nutritional intake over time between resistance training and usual care control.","['Pancreatic cancer patients', 'pancreatic cancer patients', 'Pancreatic Cancer Patients']","['6-month resistance training', 'supervised resistance training or home-based resistance training vs. usual care control']","['Nutritional intake', 'nutritional intake', 'low energy intake']","[{'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",59.0,0.00765132,"In the total of 46 patients who finished the 6-month intervention period, there was no difference in nutritional intake over time between resistance training and usual care control.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steindorf', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Clauss', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Rötzer', 'Affiliation': 'Division of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Division of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}]",Nutrition and cancer,['10.1080/01635581.2022.2077382']
1167,35609943,Impact of dapagliflozin treatment on renal function and diuretics use in acute heart failure: a pilot study.,"OBJECTIVE


To determine the impact of sodium-dependent glucose type 2 cotransporter inhibitors on the renal function in acute heart failure.
METHODS


In a single-centre, controlled, randomised study, patients were prescribed dapagliflozin in addition to standard therapy, or were in receipt of standard therapy. The prespecified outcome was renal function deterioration; the secondary outcomes were the development of resistance to diuretics, weight loss, death during hospitalisation and the rehospitalisation or death for any reason within 30 days following discharge.
RESULTS


102 patients were included (73.4±11.7 years, 57.8% men). The average left ventricular ejection fraction was 44.9%±14.7%, the average N-terminal prohormone of brain natriuretic peptide (NT-proBNP) was 4706 (1757; 11 244) pg/mL, the average estimated glomerular filtration rate (eGFR) was 51.6±19.5 mL/min. eGFR decreased 48 hours after randomisation in the dapagliflozin group (-4.2 (-11.03; 2.28) mL/min vs 0.3 (-6; 6) mL/min; p=0.04) but did not differ between the groups on discharge (54.71±19.18 mL/min and 58.92±24.65 mL/min; p=0.36). The incidence of worsening renal function did not differ (34.4% vs 15.2%; p=0.07). In the dapagliflozin group, there was less tendency to increase the dose of loop diuretics (14% vs 30%; p=0.048), lower average doses of loop diuretics (78.46±38.95 mg/day vs 102.82±31.26 mg/day; p=0.001) and more significant weight loss (4100 (2950; 5750) g vs 3000 (1380; 4650) g; p=0.02). In-hospital mortality was 7.8% (4(8%) in the dapagliflozin and 4 (7.7%) in the control group (p=0.95). The number of deaths within 30 days following discharge in the dapagliflozin group and in the control group was 9 (19%) and 12 (25%), p=0.55; the number of rehospitalisations was 14 (29%) and 17 (35%), respectively (p=0.51).
CONCLUSION


The use of dapagliflozin was associated with a more pronounced weight loss and less need to increase diuretic therapy without significant deterioration of the renal function. Dapagliflozin did not improve the in-hospital and 30-day prognosis after discharge.
TRIAL REGISTRATION NUMBER


N04778787.",2022,The incidence of worsening renal function did not differ (34.4% vs 15.2%; p=0.07).,"['102 patients were included (73.4±11.7 years, 57.8% men', 'acute heart failure']","['Dapagliflozin', 'dapagliflozin', 'sodium-dependent glucose type 2 cotransporter inhibitors']","['glomerular filtration rate (eGFR', 'eGFR', 'incidence of worsening renal function', 'hospital and 30-day prognosis', 'weight loss', 'number of rehospitalisations', 'dose of loop diuretics', 'hospital mortality', 'number of deaths', 'average left ventricular ejection fraction', 'renal function deterioration', 'development of resistance to diuretics, weight loss, death during hospitalisation and the rehospitalisation or death for any reason within 30 days following discharge', 'renal function and diuretics use']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",102.0,0.0782078,The incidence of worsening renal function did not differ (34.4% vs 15.2%; p=0.07).,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Charaya', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation charaya9716@gmail.com.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Shchekochikhin', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Andreev', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Dyachuk', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Tarasenko', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Poltavskaya', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation.'}, {'ForeName': 'Dinara', 'Initials': 'D', 'LastName': 'Mesitskaya', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bogdanova', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Ananicheva', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Kuzub', 'Affiliation': 'Department of Cardiology, Functional and Ultrasound Diagnostics, Sechenov University, Moskva, Moskva, Russian Federation.'}]",Open heart,['10.1136/openhrt-2021-001936']
1168,35609929,"Comparing genome sequencing technologies to improve rare disease diagnostics: a protocol for the evaluation of a pilot project, Genome-wide Sequencing Ontario.","BACKGROUND


Genome-wide sequencing has emerged as a promising strategy for the timely diagnosis of rare diseases, but it is not yet available as a clinical test performed in Canadian diagnostic laboratories. We describe the protocol for evaluating a 2-year pilot project, Genome-wide Sequencing Ontario, to offer high-quality clinical genome-wide sequencing in Ontario, Canada.
METHODS


The Genome-wide Sequencing Ontario protocol was codesigned by the Ontario Ministry of Health, the Hospital for Sick Children in Toronto and the Children's Hospital of Eastern Ontario in Ottawa. Enrolment of a prospective cohort of patients began on Apr. 1, 2021. Eligible cases with blood samples available for the index case and both parents (i.e., trios) are randomized to receive exome sequencing or genome sequencing. We will collect patient-level data and ascertain costs associated with the laboratory workflow for exome sequencing and genome sequencing. We will compare point estimates for the diagnostic utility and timeliness of exome sequencing and genome sequencing, and we will determine an incremental cost-effectiveness ratio (expressed as the incremental cost of genome sequencing versus exome sequencing per additional patient with a causal variant detected).
INTERPRETATION


Findings from this work will provide robust evidence for the diagnostic utility, cost-effectiveness and timeliness of exome sequencing and genome sequencing, and will be disseminated via academic publications and policy briefs. Findings will inform provincial and cross-provincial policy related to the long-term organization, delivery and reimbursement of clinical-grade genome diagnostics for rare disease.",2022,"We describe the protocol for evaluating a 2-year pilot project, Genome-wide Sequencing Ontario, to offer high-quality clinical genome-wide sequencing in Ontario, Canada.
","['patients began on Apr. 1, 2021', 'Eligible cases with blood samples available for the index case and both parents (i.e., trios', ""Sick Children in Toronto and the Children's Hospital of Eastern Ontario in Ottawa""]",[],['incremental cost-effectiveness ratio'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1448979', 'cui_str': 'TRIO protein, human'}, {'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0029040', 'cui_str': 'Ontario'}]",[],"[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0830607,"We describe the protocol for evaluating a 2-year pilot project, Genome-wide Sequencing Ontario, to offer high-quality clinical genome-wide sequencing in Ontario, Canada.
","[{'ForeName': 'Robin Z', 'Initials': 'RZ', 'LastName': 'Hayeems', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont. robin.hayeems@sickkids.ca.""}, {'ForeName': 'Christian R', 'Initials': 'CR', 'LastName': 'Marshall', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Meredith K', 'Initials': 'MK', 'LastName': 'Gillespie', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Szuto', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Chisholm', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Dimitri J', 'Initials': 'DJ', 'LastName': 'Stavropoulos', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Viji', 'Initials': 'V', 'LastName': 'Venkataramanan', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Tsiplova', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sawyer', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'E Magda', 'Initials': 'EM', 'LastName': 'Price', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Lau', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Whiwon', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Lijia', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Jarinova', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Ungar', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mendoza-Londono', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Somerville', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}, {'ForeName': 'Kym M', 'Initials': 'KM', 'LastName': 'Boycott', 'Affiliation': ""Program in Child Health Evaluative Sciences (Hayeems, Venkataramanan, Tsiplova, Lee, Ungar), Hospital for Sick Children Research Institute; Department of Paediatric Laboratory Medicine (Marshall, Stavropoulos, Lau, Somerville), Hospital for Sick Children, Toronto, Ont.; Department of Laboratory Medicine and Pathobiology, (Marshall, Stavropoulos, Somerville), University of Toronto, Toronto, Ont.; Children's Hospital of Eastern Ontario Research Institute (Gillespie, Price, Boycott), University of Ottawa, Ottawa, Ont.; Division of Clinical and Metabolic Genetics (Szuto, Khan, Lee, Mendoza-Londono), Hospital for Sick Children, Toronto, Ont.; Department of Genetics (Chisholm, Sawyer, Huang, Jarinova, Boycott), Children's Hospital of Eastern Ontario, Ottawa, Ont.""}]",CMAJ open,['10.9778/cmajo.20210272']
1169,35609816,Intermittent theta burst stimulation (iTBS) versus 10 Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) to alleviate treatment-resistant unipolar depression: A randomized controlled trial (THETA-DEP).,"BACKGROUND


Recently intermittent theta burst stimulation (iTBS) proved to be non-inferior to conventional repetitive transcranial magnetic stimulation (10 Hz rTMS) in unipolar depression after failure of one antidepressant trial, but to date no randomized control trial assessed the ability of iTBS to improve depression level and quality of life in more resistant features of depression with a long-term (6 month) follow-up in comparison to 10 Hz rTMS.
OBJECTIVES/HYPOTHESIS


The aim of our study was to compare the efficacy of 10 Hz rTMS and iTBS in treatment-resistant unipolar depression on response rates (50% decrease of MADRS scores at one month from baseline) and change in quality of life during a 6-month follow-up. In addition, we investigated whether some clinical features at baseline were associated with the response in the different groups.
METHOD


Sixty patients were randomized in a double-blind, controlled study at the University Hospital Center of Nantes, and received 20 sessions of either rTMS or iTBS applied to the left dorsolateral prefrontal cortex targeted by neuronavigation. Statistical analysis used Fischer's exact test and Chi-square test as appropriate, linear mixed model, and logistic regression (occurrence of depressive relapse and factors associated with the therapeutic response).
RESULTS


Included patients showed in mean more than 3 antidepressants trials. Response rates were 36.7% and 33.3%, and remission rates were 18.5% and 14.8%, in the iTBS and 10 Hz rTMS groups respectively. Both groups showed a similar significant reduction in depression scores and quality of life improvement at 6 months. We did not find any clinical predictive factor of therapeutic response in this sample.
CONCLUSION


Our study suggests the clinical interest of iTBS stimulation (which is more time saving and cost-effective as conventional rTMS) to provide long-lasting improvement of depression and quality of life in highly resistant unipolar depression.",2022,Both groups showed a similar significant reduction in depression scores and quality of life improvement at 6 months.,['Sixty patients'],"['Intermittent theta burst stimulation (iTBS) versus 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS', 'intermittent theta burst stimulation (iTBS', '10\u202fHz rTMS and iTBS', 'conventional repetitive transcranial magnetic stimulation (10\u202fHz rTMS', 'rTMS or iTBS']","['depression scores and quality of life improvement', 'Response rates', 'remission rates', 'quality of life', 'MADRS scores', 'depression level and quality of life', 'response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",60.0,0.0446474,Both groups showed a similar significant reduction in depression scores and quality of life improvement at 6 months.,"[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bulteau', 'Affiliation': 'CHU Nantes, Clinical Investigation Unit 18, Department of Addictology and Psychiatry, F-44000, Nantes, France; Nantes Université, CHU Nantes, INSERM, MethodS in Patients-centered outcomes and HEalth Research, SPHERE, F-44000, Nantes, France. Electronic address: samuel.bulteau@chu-nantes.fr.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Laurin', 'Affiliation': 'CHU Nantes, Clinical Investigation Unit 18, Department of Addictology and Psychiatry, F-44000, Nantes, France.'}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Pere', 'Affiliation': 'CHU Nantes, Department of Biostatistics, F-44000, Nantes, France.'}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Fayet', 'Affiliation': 'CHU Nantes, Department of Clinical Neurophysiology, F-44000, Nantes, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Thomas-Ollivier', 'Affiliation': 'Nantes Université, CHU Nantes, Movement - Interactions - Performance, MIP, UR 4334, F-44000, Nantes, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Deschamps', 'Affiliation': 'Nantes Université, CHU Nantes, Movement - Interactions - Performance, MIP, UR 4334, F-44000, Nantes, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Auffray-Calvier', 'Affiliation': 'CHU Nantes, Department of Neuroradiology, F-44000, Nantes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bukowski', 'Affiliation': 'CHU Nantes, Clinical Investigation Unit 18, Department of Addictology and Psychiatry, F-44000, Nantes, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Vanelle', 'Affiliation': 'CHU Nantes, Clinical Investigation Unit 18, Department of Addictology and Psychiatry, F-44000, Nantes, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Sébille', 'Affiliation': 'Nantes Université, CHU Nantes, INSERM, MethodS in Patients-centered outcomes and HEalth Research, SPHERE, F-44000, Nantes, France; CHU Nantes, Department of Biostatistics, F-44000, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sauvaget', 'Affiliation': 'CHU Nantes, Clinical Investigation Unit 18, Department of Addictology and Psychiatry, F-44000, Nantes, France; Nantes Université, CHU Nantes, Movement - Interactions - Performance, MIP, UR 4334, F-44000, Nantes, France.'}]",Brain stimulation,['10.1016/j.brs.2022.05.011']
1170,35609815,Home-based transcranial static magnetic field stimulation of the motor cortex for treating levodopa-induced dyskinesias in Parkinson's disease: A randomized controlled trial.,,2022,,"[""Parkinson's disease""]",['levodopa-induced dyskinesias'],[],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]",[],,0.141,,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Dileone', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain; Faculty of Health Sciences, UCLM Talavera, Toledo, Spain; Neurology Department, Hospital Virgen del Puerto, Plasencia, Cáceres, Spain.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ammann', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Catanzaro', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pagge', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain; Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Piredda', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.'}, {'ForeName': 'Mariana H G', 'Initials': 'MHG', 'LastName': 'Monje', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain; Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Navalpotro-Gomez', 'Affiliation': 'Instituto Biodonostia, Hospital Universitario Donostia, San Sebastián, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bergareche', 'Affiliation': 'Instituto Biodonostia, Hospital Universitario Donostia, San Sebastián, Spain.'}, {'ForeName': 'María Cruz', 'Initials': 'MC', 'LastName': 'Rodríguez-Oroz', 'Affiliation': 'Neurology Department, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Vela-Desojo', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain; Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alonso-Frech', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain; Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Catalán', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Molina', 'Affiliation': 'Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'López-Ariztegu', 'Affiliation': 'Hospital Universitario de Toledo, Toledo, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Oliviero', 'Affiliation': 'Hospital Nacional de Parapléjicos, Toledo, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Obeso', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain; CIBERNED, Instituto de Salud Carlos III, Madrid, Spain; Universidad CEU-San Pablo, Madrid, Spain.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Foffani', 'Affiliation': 'HM CINAC (Centro Integral de Neurociencias Abarca Campal), Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain; Hospital Nacional de Parapléjicos, Toledo, Spain; CIBERNED, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: gfoffani.hmcinac@hmhospitales.com.'}]",Brain stimulation,['10.1016/j.brs.2022.05.012']
1171,35616265,Short term effect of spinal mobilization with movement (MWM) on pulmonary functions in nonsmokers with thoracic hyperkyphosis: a randomized single-blinded controlled trial.,"OBJECTIVES


To investigate the effect of mobilization with movement (MWM) on pulmonary functions in subjects with thoracic hyperkyphosis.
METHODS


This randomized single-blinded controlled trial included a sample of 50 subjects (age 18 - 25 years old) with thoracic hyperkyphosis. Subjects were randomly allocated into two groups; the Real MWM group (n = 25) which received thoracic MWM plus standard postural correction exercises, and the Sham MWM group (n = 25) which received sham MWM plus standard postural correction exercises. Digital X-ray and handheld spirometer were used to measure selected pulmonary function tests (FVC, FEV1/FVC ratio, MVV) respectively.
RESULTS


Within-group comparisons demonstrated a statistically significant improvement in all outcome measures in both groups. The between-group comparisons demonstrated significant improvement in the MWM compared to the Sham group regarding the value of FVC, FEV1/FVC ratio, and MVV (P < .05).
CONCLUSION


In young adults with thoracic hyperkyphosis, MWM plus postural exercise produces better improvements in FVC, FEV1, FEV1/FVC, and MVV compared to sham MWM plus postural exercise.",2022,"The between-group comparisons demonstrated significant improvement in the MWM compared to the Sham group regarding the value of FVC, FEV1/FVC ratio, and MVV (P ","['nonsmokers with thoracic hyperkyphosis', 'subjects with thoracic hyperkyphosis', '50 subjects (age 18\xa0-\xa025\xa0years old) with thoracic hyperkyphosis', 'young adults with thoracic hyperkyphosis']","['spinal mobilization with movement (MWM', 'MWM plus postural exercise', 'mobilization with movement (MWM', 'Real MWM group (n\xa0=\xa025) which received thoracic MWM plus standard postural correction exercises, and the Sham MWM group (n\xa0=\xa025) which received sham MWM plus standard postural correction exercises', 'Digital X-ray and handheld spirometer']","['pulmonary functions', 'MWM', 'value of FVC, FEV1/FVC ratio, and MVV (P', 'FVC, FEV1, FEV1/FVC, and MVV']","[{'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0150716', 'cui_str': 'Postural exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0183441', 'cui_str': 'Spirometer'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024967', 'cui_str': 'Maximum voluntary ventilation'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",50.0,0.174485,"The between-group comparisons demonstrated significant improvement in the MWM compared to the Sham group regarding the value of FVC, FEV1/FVC ratio, and MVV (P ","[{'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'El Gendy', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Shaimaa R', 'Initials': 'SR', 'LastName': 'Mohamed', 'Affiliation': 'Physical Therapy Department, Sherbin General Hospital, Dakahlia, Egypt.'}, {'ForeName': 'Saher E', 'Initials': 'SE', 'LastName': 'Taman', 'Affiliation': 'Intervention Radiology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hisham M', 'Initials': 'HM', 'LastName': 'Hussein', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Shimaa T', 'Initials': 'ST', 'LastName': 'Abu El Kasem', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2022.2075203']
1172,35616352,Does individualized care make a difference in postpartum discharge?: A block randomized controlled trial.,"With this study, we aimed to determine the severity of physical symptoms displayed by mothers who received individualized care during the early postpartum period and their level of perceived readiness for discharge after birth. We conducted the study as a single-blind randomized controlled trial, assigning the mothers to the experimental (EG = 60) and control (CG = 60) groups using the permuted block randomization method. We administered the EG individualized care and the CG a routine care. Both groups received Postpartum Physical Symptom Severity Scale and Readiness for Hospital Discharge Scale-New Mother Form. The mean posttest scores the groups obtained from Postpartum Physical Symptom Severity Scale and Readiness for Hospital Discharge Scale-New Mother Form were significant in favor of the EG (p < 0.05). It is fair to state that individualized care is effective in reducing the physical complaints increasing the maternal health and improving the general health.",2022,The mean posttest scores the groups obtained from Postpartum Physical Symptom Severity Scale and Readiness for Hospital Discharge Scale-New Mother Form were significant in favor of the EG (p < 0.05).,"['mothers who received individualized care during the early postpartum period and their level of perceived readiness for discharge after birth', 'mothers to the experimental (EG = 60) and control (CG = 60) groups using the permuted block randomization method']",[],['Postpartum Physical Symptom Severity Scale and Readiness for Hospital Discharge Scale-New Mother Form'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],"[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",,0.0693002,The mean posttest scores the groups obtained from Postpartum Physical Symptom Severity Scale and Readiness for Hospital Discharge Scale-New Mother Form were significant in favor of the EG (p < 0.05).,"[{'ForeName': 'Cigdem Gun', 'Initials': 'CG', 'LastName': 'Kakasci', 'Affiliation': 'Faculty of Health Sciences, Department of Midwifery, Suleyman Demirel University, Isparta, Turkey.'}, {'ForeName': 'Aysegul', 'Initials': 'A', 'LastName': 'Durmaz', 'Affiliation': 'Faculty of Health Sciences, Department of Midwifery, Kutahya Health Sciences University, Kutahya, Turkey.'}]",Health care for women international,['10.1080/07399332.2022.2046752']
1173,35594292,The Disinhibiting Effects of Anonymity Increase Online Trolling.,"Research assessing online trolling-a behavior designed to trigger or antagonize other users for entertainment-has largely focused on identifying individual differences that underlie the behavior. Less attention has been given to how situational factors influence trolling, such as the disinhibiting effects of anonymity. In this study, we evaluated the roles of both individual differences and levels of anonymity in online trolling. We assessed these through experimentation, a relatively novel approach in trolling research. Australian undergraduate students ( n  = 242, 167 women, 75 men,  M age  = 21.18) were allocated to one of three conditions: an anonymous condition where they were not visible to one another, an identifiable condition where they were visible to one another, or an external condition where they completed the study outside of a controlled laboratory environment. Participants first read a short news article before interacting in an online group discussion where participants could chat freely. The first comment participants wrote was later coded for trolling. Participants also completed assessments of psychopathy, sadism, and a global assessment of trolling. As predicted, participants in the anonymous condition trolled more than those in the identifiable condition. No differences were seen between these two conditions and the external condition. Analyses also revealed that sadism and global trolling were positively associated with trolling in the chat room, but psychopathy showed no association. These results demonstrate the importance of both individual differences and the disinhibiting effects of anonymity when investigating the complex nature of trolling.",2022,No differences were seen between these two conditions and the external condition.,"['Australian undergraduate students ( n \u2009=\u2009242, 167 women, 75 men,  M age \u2009=\u200921.18']",[],['sadism and global trolling'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0036039', 'cui_str': 'Sadism'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0318628,No differences were seen between these two conditions and the external condition.,"[{'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Nitschinsk', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Tobin', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Vanman', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2022.0005']
1174,35594778,Changes in sleep following internet-delivered cognitive-behavioral therapy for insomnia in women treated for breast cancer: A 3-year follow-up assessment.,"BACKGROUND


Sleep disturbances are common in women treated for breast cancer. We have previously shown that internet-delivered cognitive-behavioral therapy for insomnia (e-CBT-I) is an efficacious, low-cost treatment approach. Furthermore, research has shown that e-CBT-I can result in sustained improvements at 12 months post-treatment. However, given the complexity and long duration of post-treatment symptomatology in breast cancer patients, as well as the recommended use of antihormonal therapy for up to 10 years, it is relevant to investigate long-term (>12 months) changes in sleep following e-CBT-I in this population. In the present study, we report data from a 3-year long-term follow-up assessment after e-CBT-I.
METHODS


Women treated for breast cancer with sleep disturbances (Pittsburg Sleep Quality Index [PSQI] global score >5) who had previously been enrolled in a randomized-controlled trial investigating the efficacy of e-CBT-I (n = 255), were invited to participate in a 3-year follow-up study. All women in the initial control group had also been granted access to e-CBT-I. Assessment included self-reported sleep quality (PSQI), insomnia severity (Insomnia Severity Index, ISI), cancer-related fatigue and symptoms of depression. Within-group changes in these outcomes from baseline to the 3-year long-term follow-up assessment were analyzed.
RESULTS


A total of 131 women (51%) participated in the 3-year follow-up study of which 77 (59%) were from the initial intervention group and 54 (41%) from the initial control group. For the pooled sample, within-group improvements from baseline to the 3-year follow-up assessment corresponding to large effect sizes were observed in sleep quality (Cohen's d = 1.0 95% CI [0.78, 1.21]) and insomnia severity (Cohen's d = 1.36 CI 95% [1.12, 1.59]). Similar changes were observed in cancer-related fatigue (Cohen's d = 0.48 CI 95% [0.30, 0.66]) and symptoms of depression (Cohen's d = 0.80 CI 95%. [0.60, 0.99]). The proportion of patients with scores above established cut-offs on the PSQI and the ISI were 56.1% and 29.8%, respectively. Within the initial intervention group, 15.6% evidenced relapse at the 3-year assessment.
CONCLUSION


Overall, these results indicate that long-term sleep quality and insomnia severity following the use of e-CBT-in women treated for breast cancer is significantly lower than the pre-treatment levels. However, a substantial proportion of participants still evidence sleep disturbances.",2022,"Similar changes were observed in cancer-related fatigue (Cohen's d = 0.48 CI 95% [0.30, 0.66]) and symptoms of depression (Cohen's d = 0.80 CI 95%.","['breast cancer patients', 'Women treated for breast cancer with sleep disturbances (Pittsburg Sleep Quality Index [PSQI] global score >5) who had previously been enrolled in a randomized-controlled trial investigating the efficacy of e-CBT-I (n\xa0=\xa0255', '131 women (51%) participated in the 3-year follow-up study of which 77 (59%) were from the initial intervention group and 54 (41%) from the initial control group', 'women treated for breast cancer']",['internet-delivered cognitive-behavioral therapy'],"['sleep quality', 'long-term sleep quality and insomnia severity', 'symptoms of depression', 'cancer-related fatigue', 'insomnia severity', 'granted access to e-CBT-I. Assessment included self-reported sleep quality (PSQI), insomnia severity (Insomnia Severity Index, ISI), cancer-related fatigue and symptoms of depression']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",131.0,0.0599647,"Similar changes were observed in cancer-related fatigue (Cohen's d = 0.48 CI 95% [0.30, 0.66]) and symptoms of depression (Cohen's d = 0.80 CI 95%.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Amidi', 'Affiliation': 'Unit for Psychooncology & Health Psychology, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark; Sleep & Circadian Psychology Research Group, Department of Psychology & Behavioural Sciences, Aarhus University, Aarhus, Denmark. Electronic address: ali@psy.au.dk.'}, {'ForeName': 'Cecilie R', 'Initials': 'CR', 'LastName': 'Buskbjerg', 'Affiliation': 'Unit for Psychooncology & Health Psychology, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark; Department of Oncology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: cdrc@psy.au.dk.'}, {'ForeName': 'Malene F', 'Initials': 'MF', 'LastName': 'Damholdt', 'Affiliation': 'Unit for Psychooncology & Health Psychology, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: malenefd@psy.au.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Dahlgaard', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark; Program for Mind and Body in Mental Health, Research Centre for Health and Welfare Technology, VIA University College, Aarhus, Denmark. Electronic address: jesd@via.dk.'}, {'ForeName': 'Frances P', 'Initials': 'FP', 'LastName': 'Thorndike', 'Affiliation': 'Department of Psychiatry and Neurobehavioral Sciences, Pear Therapeutics, Boston, MA, USA. Electronic address: frances.thorndike@peartherapeutics.com.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ritterband', 'Affiliation': 'Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Center for Behavioral Health & Technology, Charlottesville, VA, USA. Electronic address: leer@virginia.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zachariae', 'Affiliation': 'Unit for Psychooncology & Health Psychology, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark; Department of Oncology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: bzach@rm.dk.'}]",Sleep medicine,['10.1016/j.sleep.2022.04.020']
1175,35595254,Twice Weekly Vs. Thrice Weekly Low-Dose Prophylactic Factor VIII Therapy in Children with Hemophilia A: An Open Label Randomized Trial.,"INTRODUCTION


Low dose factor VIII prophylactic therapy in hemophilia has not been well established till date. This randomized controlled trial compared the efficacy of twice vs. thrice weekly schedule of low dose prophylactic factor VIII in children with hemophilia A as evaluated by the bleeding rate and clinico-radiological evaluation.
METHODS


Thirty-three children with severe hemophilia A (≤18 years) were randomized into two groups. Baseline evaluation included detailed history, clinical (HJHS 2.1 score and FISH score) and radiological examination (Pettersson score and ultrasound score). Group 1 received twice weekly factor VIII prophylaxis while group 2 received thrice weekly factor VIII prophylaxis, the dose being 10 U/kg in both groups. All participants were followed up over next 6 months to one year. Data regarding acute bleeding episodes and repeat clinico-radiological assessment at the end of follow up were recorded.
RESULTS


We analyzed 14 children in twice weekly prophylaxis group and 16 children in thrice weekly prophylaxis group. Statistically insignificant difference was found between the bleeding rates in both the groups after prophylaxis with the median values of monthly bleeding rate being 0.17 and p-value of 0.79. The differences between the initial and final clinical and radiological scores within each group were found to be statistically significant. There was no significant difference in the clinical and radiological scores in between the groups.
CONCLUSION


Twice weekly FVIII therapy is effective, easily administered prophylactic schedule to prevent long-term complications of hemophilia A. Lay summaryHemophilia A is one of the most common congenital coagulation factor deficiencies. Low dose factor VIII prophylaxis is recommended for hemophilia in resource-poor settings to reduce the bleeding episodes and improve the quality of life, although the optimal schedule for the same has not been well established. A randomized controlled trial on 33 children with hemophilia A (≤18 years) was done to compare the efficacy of twice versus thrice weekly schedule of prophylactic factor VIII. Group 1 received twice weekly factor VIII prophylaxis while group 2 received thrice weekly factor VIII prophylaxis, the dose in both groups being 10 U/kg. They were evaluated by the bleeding rate and clinical (HJHS 2.1 score and FISH score) and radiological scores (Pettersson score and ultrasound score). All participants were followed up over next 6 months to one year. Data regarding acute bleeding episodes and repeat clinico-radiological assessment at end of follow up were recorded. When analyzed, statistically insignificant difference was found between the bleeding rates after the two prophylaxis regimes. There was a significant improvement between initial and final clinical and radiological scores in both the groups and no difference was recorded in between the groups. To conclude, twice weekly FVIII therapy is effective, easily administered prophylactic schedule to prevent long-term complications of hemophilia A.",2022,There was a significant improvement between initial and final clinical and radiological scores in both the groups and no difference was recorded in between the groups.,"['Children with Hemophilia A', 'Thirty-three children with severe hemophilia A (≤18\u2009years', 'children with hemophilia A', '14 children in twice weekly prophylaxis group and 16 children in thrice weekly prophylaxis group', '33 children with hemophilia A (≤18\u2009years']",['Thrice Weekly Low-Dose Prophylactic Factor VIII Therapy'],"['clinical and radiological scores', 'bleeding rates', 'detailed history, clinical (HJHS 2.1 score and FISH score) and radiological examination (Pettersson score and ultrasound score', 'quality of life', 'initial and final clinical and radiological scores', 'bleeding rate and clinical (HJHS 2.1 score and FISH score) and radiological scores (Pettersson score and ultrasound score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}]","[{'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]",33.0,0.0459778,There was a significant improvement between initial and final clinical and radiological scores in both the groups and no difference was recorded in between the groups.,"[{'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Gomber', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, New Delhi, 110095, India.'}, {'ForeName': 'Gorika', 'Initials': 'G', 'LastName': 'Singhal', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, New Delhi, 110095, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, New Delhi, 110095, India.'}, {'ForeName': 'Lalendra', 'Initials': 'L', 'LastName': 'Upreti', 'Affiliation': 'Department of Radiodiagnosis, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, New Delhi 110095, India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Sikka', 'Affiliation': 'Department of Pathology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, New Delhi 110095, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmac039']
1176,35595209,Thoracic Endovascular Aortic Repair of Highly Tapered Type B Aortic Dissection with Proximal Tapered Stent Grafts and Distal Restrictive Stent Grafts.,"BACKGROUND


This study evaluated aortic remodeling in highly tapered type B aortic dissection (TBAD) patients who underwent thoracic endovascular aortic repair (TEVAR) with a proximal tapered stent graft plus a distal restrictive stent graft to maximize thoracic coverage while avoiding distal excessive oversizing.
METHODS


Thirty-four patients presenting with highly tapered TABD were randomized to restricted TEVAR (r-TEVAR) and standard TEVAR groups. Highly tapered TBAD was defined as the maximal diameter of the true lumen at proximal and distal thoracic aorta landing zone tapers greater than 8 mm or taper ratio greater than 20%. Patients in the r-TEVAR group underwent proximal tapered stent grafts plus distal restrictive stent grafts, to match the taper ratio of the descending thoracic aorta (DTA) and extend the length of stent coverage. Patients in the standard TEVAR group underwent proximal tapered stent grafts implantation without distal restrictive stent grafts. Aortic remodeling was estimated by computed tomography angiography (CTA) during the follow-up.
RESULTS


In total, 16 patients underwent r-TEVAR, and 18 patients underwent standard TEVAR. The taper ratio of the stent graft matched the DTA in the r-TEVAR group (24.7 ± 3.4% vs. 27.3 ± 4.2%, P = 0.068), but did not match that in the standard TEVAR group (13.5 ± 3.3% vs. 30.5 ± 9.6%, P < 0.001). The length of stent graft coverage in the r-TEVAR group was longer than that in the standard TEVAR group (220.4 ± 21.1 mm vs. 175.3 ± 17.8 mm, P < 0.001). Compared with the standard TEVAR group, the r-TEVAR group had better complete remodeling of the DTA at 6 months (40% vs. 5.6%, P = 0.03), 12 months (60% vs. 16.7%, P = 0.027), and 24 months (78.6% vs. 41.2%, P = 0.036) after the operation. There was no difference in the cumulative survival rate between the r-TEVAR and standard TEVAR groups (P = 0.166).
CONCLUSIONS


The r-TEVAR with overlapping proximal tapered stent grafts and distal restrictive stent grafts can match the taper of highly tapered TABD, extend the length of stent graft coverage, and lead to better remodeling of the DTA than standard TEVAR.",2022,"The length of stent graft coverage in the r-TEVAR group was longer than that in the standard TEVAR group (220.4±21.1 mm vs. 175.3±17.8 mm, P<0.001).","['highly tapered type B aortic dissection (TBAD) patients who underwent', 'Thirty-four patients presenting with highly tapered TABD']","['computed tomography angiography (CTA', 'Thoracic endovascular aortic repair of highly tapered type B aortic dissection with proximal tapered stent grafts and distal restrictive stent grafts', 'proximal tapered stent grafts implantation without distal restrictive stent grafts', 'restricted TEVAR (r-TEVAR) and standard TEVAR', 'thoracic endovascular aortic repair (TEVAR) with a proximal tapered stent graft plus a distal restrictive stent graft', 'proximal tapered stent grafts plus distal restrictive stent grafts', 'standard TEVAR']","['cumulative survival rate', 'complete remodeling of the DTA', 'length of stent graft coverage', 'Aortic remodeling']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0340647', 'cui_str': 'Dissection of distal aorta'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0340647', 'cui_str': 'Dissection of distal aorta'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0010456', 'cui_str': 'Cumulative Survival Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1522460', 'cui_str': 'Thoracic aorta structure'}, {'cui': 'C0449462', 'cui_str': 'Length of stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}]",16.0,0.0498491,"The length of stent graft coverage in the r-TEVAR group was longer than that in the standard TEVAR group (220.4±21.1 mm vs. 175.3±17.8 mm, P<0.001).","[{'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Niu', 'Affiliation': 'Department of Vascular Surgery, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'Department of Vascular Surgery, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Pathology, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Changfeng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Vascular Surgery, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Vascular Surgery, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Vascular Surgery, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Xin', 'Affiliation': 'Department of Vascular Surgery, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Haofu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Vascular Surgery, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yuewei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Vascular Surgery, the Affiliated Hospital of Qingdao University, Qingdao, China. Electronic address: wangyw791128@hotmail.com.'}]",Annals of vascular surgery,['10.1016/j.avsg.2022.05.004']
1177,35597226,Repetitive transcranial magnetic stimulation promotes response inhibition in patients with major depression during the stop-signal task.,"BACKGROUND


Response inhibition (RI) deficit is an aspect of cognitive impairment in depressed individuals, but currently no effective treatment has been established. This study aimed to explore the effect of individualized repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (lDLPFC)-nucleus accumbens (NAcc) network on RI in patients with major depressive disorder (MDD).
METHODS


Fourty-four patients diagnosed with MDD were randomized to receive 15 once-daily sessions of active (10 Hz, 100% of resting motor threshold) or sham rTMS within a double-blind, sham-controlled trial. We measured the efficacy of rTMS by the improvements in behavioral and neurological manifestations during the stop-signal task. The Hamilton Depression Rating Scale-17 items (HAMD-17) was used to assess depressive symptoms. We analyzed the differences in RI performance between MDD patients and 30 healthy controls (HCs) at baseline and assessed whether MDD patients who completed rTMS treatment had comparable RI ability to HCs.
RESULTS


At baseline, the depressed patients showed longer stop-signal response time (SSRT), smaller P3 amplitudes, and weaker theta-band power in successful stop trials (SSTs) than HCs. The active group exhibited RI ability comparable to that of HCs after rTMS treatment, but the improvements were not significant in the sham group. The active group showed significant remission in depression symptoms post-treatment compared to the sham group, and the changes in P3 amplitudes and theta-band power during SSTs were negatively correlated with the decrease of HAMD-17 scores.
CONCLUSION


The depressed patients have impaired RI and treatment with the individualized rTMS protocol may be an effective approach.",2022,"At baseline, the depressed patients showed longer stop-signal response time (SSRT), smaller P3 amplitudes, and weaker theta-band power in successful stop trials (SSTs) than HCs.","['Fourty-four patients diagnosed with MDD', 'patients with major depression during the stop-signal task', 'patients with major depressive disorder (MDD', 'MDD patients and 30 healthy controls (HCs) at baseline and assessed whether MDD patients who completed']","['rTMS', 'individualized repetitive transcranial magnetic stimulation (rTMS', 'Repetitive transcranial magnetic stimulation', 'receive 15 once-daily sessions of active (10\xa0Hz, 100% of resting motor threshold) or sham rTMS']","['RI performance', 'Hamilton Depression Rating Scale-17 items (HAMD-17', 'HAMD-17 scores', 'RI ability to HCs', 'behavioral and neurological manifestations', 'P3 amplitudes and theta-band power during SSTs', 'longer stop-signal response time (SSRT), smaller P3 amplitudes, and weaker theta-band power in successful stop trials (SSTs', 'depressive symptoms', 'remission in depression symptoms', 'RI ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027854', 'cui_str': 'Neurologic Manifestation'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0324406,"At baseline, the depressed patients showed longer stop-signal response time (SSRT), smaller P3 amplitudes, and weaker theta-band power in successful stop trials (SSTs) than HCs.","[{'ForeName': 'Fengqiong', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yunheng', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yaru', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Kongliang', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'Anhui Mental Health Center, Hefei, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China. Electronic address: wangkai1964@126.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China. Electronic address: 13866129450@163.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.05.014']
1178,35598533,Evaluation of the effectiveness of an automated sepsis predictive tool on patient outcomes.,"PURPOSE


To evaluate the effectiveness of a multidisciplinary, hospital-wide program as part of an electronic sepsis alert tool.
MATERIALS AND METHODS


We used data from 15 hospitals about adult patients with severe sepsis or septic shock. Nine intervention hospitals implemented an Epic sepsis prediction tool, education, and standardized order sets (six control hospitals did not). A difference-in-difference approach evaluated their effectiveness: 1) pre-implementation period (January 1, 2016-November 15, 2018) and 2) implementation period (November 16, 2018-June 30, 2019).
RESULTS


Outcomes included mortality, receipt of the SEP-1 bundle of care, broad spectrum antibiotic use, ICU stay, and length of stay of 6926 patients. The difference of 6.7 percentage points between the intervention and control groups in SEP-1 bundle completion was not statistically significant (p = 0.105). The increase over time for antibiotic administration ≤1 h of time zero was not larger for hospitals in the intervention group (11.7%) compared to the control-group (7.6%, p = 0.084). Differences among hospitals in both groups were not statistically different for mortality (p = 0.174), ICU stays (p = 0.174), and length of stay (p = 0.652) from pre- to implementation period.
CONCLUSIONS


The intervention to facilitate timely sepsis care did not improve patient outcomes among those with severe sepsis or septic shock.",2022,"Differences among hospitals in both groups were not statistically different for mortality (p = 0.174), ICU stays (p = 0.174), and length of stay (p = 0.652) from pre- to implementation period.
",['15 hospitals about adult patients with severe sepsis or septic shock'],[],"['ICU stays', 'mortality', 'length of stay', 'increase over time for antibiotic administration ≤1 h of time zero', 'mortality, receipt of the SEP-1 bundle of care, broad spectrum antibiotic use, ICU stay, and length of stay', 'SEP-1 bundle completion']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]",[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0286349,"Differences among hospitals in both groups were not statistically different for mortality (p = 0.174), ICU stays (p = 0.174), and length of stay (p = 0.652) from pre- to implementation period.
","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Schootman', 'Affiliation': 'SSM Health, Department of Clinical Analytics, 10101 Woodfield Lane, St. Louis, MO 63132, United States of America. Electronic address: mschootman@uams.edu.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Wiskow', 'Affiliation': 'SSM Health, Department of Clinical Analytics, 10101 Woodfield Lane, St. Louis, MO 63132, United States of America. Electronic address: Cara.wiskow@ssmhealth.com.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Loux', 'Affiliation': 'Saint Louis University, College for Public Health and Social Justice, Department of Epidemiology and Biostatistics, Saint Louis, MO, United States of America. Electronic address: Travis.loux@slu.edu.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'SSM Health, Center for Clinical Excellence, St. Louis, MO, United States of America. Electronic address: Leah.B.Meyer@ssmhealth.com.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Powell', 'Affiliation': 'SSM Health, Center for Clinical Excellence, St. Louis, MO, United States of America. Electronic address: Shelley.Powell@ssmhealth.com.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gandhi', 'Affiliation': ""SSM Health, Department of Internal Medicine, St. Mary's Health Center, St. Louis, MO, United States of America. Electronic address: Avi.gandhi@ssmhealth.cm.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lacasse', 'Affiliation': ""SSM Health, Department of Internal Medicine, St. Mary's Health Center, St. Louis, MO, United States of America. Electronic address: Alexandre.Lacasse@ssmhealth.com.""}]",Journal of critical care,['10.1016/j.jcrc.2022.154061']
1179,35598501,"A randomized, open-label pilot trial of selective serotonin reuptake inhibitors on neuropsychological functions in patients with obsessive compulsive disorder.","BACKGROUND


There is enough empirical literature suggesting impairments in neuropsychological functioning in patients with obsessive compulsive disorder (OCD) despite inconsistencies.
AIM


The aim of the index study was to study the effect of Selective Serotonin Reuptake Inhibitors (SSRIs) on neuropsychological functions and illness severity in drug-naïve subjects with OCD.
METHODS


A total of 50 subjects with diagnosis of obsessive-compulsive disorder (DSM-5) in the age range of 18-55 years, drug naïve, without comorbid depression/anxiety disorders were randomized to receive either Sertraline or Fluvoxamine. Neuropsychological functions and severity of illness were evaluated using NIMHANS neuropsychological battery and Y-BOCS at baseline and 12 weeks posttreatment with SSRIs.
RESULTS


At baseline, study subjects had moderate severity of OCD and neuropsychological functions were impaired in a substantial number of subjects. More than half of the subjects were having impairment in verbal fluency and category fluency i.e., executive function impairment; the scores for DSST, DVT (assessing mental speed and sustained attention), Verbal N Back 1 error (assessing verbal working memory) WCST total trials (assessing set shifting) were found to be significantly correlated with Y-BOCS score i.e. severity of illness. Significant improvement was observed in both the illness severity and neuropsychological functions at end point. The proportion of adequate performers on various neuropsychological tests increased significantly at 12 weeks.
CONCLUSION


A substantial number of patients with OCD have neuropsychological impairments, however, the pattern of impairments does not follow any sequence. Adequate management of OCD with SSRIs leads to improvement in both illness severity and neuropsychological functions in the short term.",2022,Significant improvement was observed in both the illness severity and neuropsychological functions at end point.,"['50 subjects with diagnosis of obsessive-compulsive disorder (DSM-5) in the age range of 18-55 years, drug naïve, without comorbid depression/anxiety disorders', 'drug-naïve subjects with OCD', 'patients with obsessive compulsive disorder', 'patients with obsessive compulsive disorder (OCD']","['Selective Serotonin Reuptake Inhibitors (SSRIs', 'Sertraline or Fluvoxamine', 'selective serotonin reuptake inhibitors']","['Neuropsychological functions and severity of illness', 'neuropsychological functions', 'various neuropsychological tests', 'illness severity and neuropsychological functions', 'verbal fluency and category fluency i.e., executive function impairment; the scores for DSST, DVT (assessing mental speed and sustained attention), Verbal N Back 1 error (assessing verbal working memory) WCST total trials', 'neuropsychological functions and illness severity', 'moderate severity of OCD and neuropsychological functions']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0085228', 'cui_str': 'Fluvoxamine'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]",50.0,0.0485419,Significant improvement was observed in both the illness severity and neuropsychological functions at end point.,"[{'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Brar', 'Affiliation': 'Dept. of Psychiatry, Govt. Medical College & Hospital, Chandigarh, India. Electronic address: jasminebrar2014@gmail.com.'}, {'ForeName': 'Ajeet', 'Initials': 'A', 'LastName': 'Sidana', 'Affiliation': 'Dept. of Psychiatry, Govt. Medical College & Hospital, Chandigarh, India. Electronic address: ajeetsidana@gmail.com.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Chauhan', 'Affiliation': 'Dept. of Psychiatry, Govt. Medical College & Hospital, Chandigarh, India. Electronic address: dr.nidhichauhan@gmail.com.'}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Bajaj', 'Affiliation': 'Govt. Medical College & Hospital, Chandigarh, India. Electronic address: mkbajaj@gmail.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.05.002']
1180,35605339,A structured accelerated versus control rehabilitation pathway after anterior cruciate ligament reconstruction using autologous hamstrings demonstrates earlier improvement in physical outcomes without increasing graft laxity: A randomized controlled trial.,"OBJECTIVES


To investigate whether an accelerated rehabilitation pathway could enhance strength and functional symmetry after ACLR, without affecting laxity.
DESIGN


Randomized Controlled Trial.
SETTING


Private rehabilitation clinic.
PARTICIPANTS


44 patients randomized to an 'Accelerated' (n = 22) or 'Control' (n = 22) rehabilitation intervention.
MAIN OUTCOME MEASURES


Graft laxity (primary outcome), isokinetic knee extensor and flexor strength, hop tests, surveys, sport participation, re-injuries and re-operations.
RESULTS


No knee laxity differences (p > 0.05) were observed. A significantly greater (p = 0.006) percentage of Accelerated (77.3%) versus Control (59.1%) patients were participating in Level 1 or 2 pivoting sports at 12 months. Greater limb symmetry indices were observed in the Accelerated group for knee extensor strength at 6 (p < 0.0001), 12 (p = 0.010) and 24 (p = 0.005) months, as well as the triple hop at 6 (p = 0.015) and 9 (p = 0.008) months, and the triple crossover hop at 6 (p < 0.0001) and 9 (p = 0.009) months. One ipsilateral re-tear was observed (Control group, 17 months). No differences (p˃0.05) existed in surveys apart from the Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score, better (p = 0.001) in the Accelerated group at 12 months.
CONCLUSIONS


Accelerated rehabilitation produced earlier improvement in strength and hop LSIs, without increasing graft laxity.",2022,"No differences (p˃0.05) existed in surveys apart from the Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score, better (p = 0.001) in the Accelerated group at 12 months.
","['graft laxity', ""44 patients randomized to an 'Accelerated' (n\xa0=\xa022) or"", 'Private rehabilitation clinic']","['control rehabilitation pathway after anterior cruciate ligament reconstruction using autologous hamstrings', ""Control' (n\xa0=\xa022) rehabilitation intervention""]","['Graft laxity (primary outcome), isokinetic knee extensor and flexor strength, hop tests, surveys, sport participation', 'knee extensor strength', 'strength and hop LSIs', 'Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score', 'graft laxity', 'knee laxity differences', 'Greater limb symmetry indices']","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0035127', 'cui_str': 'Repetitive strain injury'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",44.0,0.030932,"No differences (p˃0.05) existed in surveys apart from the Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score, better (p = 0.001) in the Accelerated group at 12 months.
","[{'ForeName': 'Jay R', 'Initials': 'JR', 'LastName': 'Ebert', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), University of Western Australia, Crawley, Western Australia, 6009, Australia; HFRC Rehabilitation Clinic, 117 Stirling Highway, Nedlands, Western Australia, 6009, Australia. Electronic address: jay.ebert@uwa.edu.au.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'School of Allied Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Joss', 'Affiliation': 'HFRC Rehabilitation Clinic, 117 Stirling Highway, Nedlands, Western Australia, 6009, Australia.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Annear', 'Affiliation': 'Perth Orthopaedic & Sports Medicine Centre, West Perth, Western Australia, 6005, Australia.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2022.05.005']
1181,35606886,"Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial.","BACKGROUND


People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists.
METHODS


Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5-10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement.
DISCUSSION


The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use.
TRIAL REGISTRATION


ISRCTN93382525 (03/08/20).",2022,"The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use.
","['people with psychosis', 'people with co-morbid post-traumatic stress disorder and psychosis', 'participants and therapists', 'Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site']","['cognitive behaviour therapy', 'TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp', 'TF-CBTp']","['PTSD symptom severity', 'Therapy acceptability', 'loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",300.0,0.113621,"The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use.
","[{'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hardy', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. amy.hardy@kcl.ac.uk.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dudley', 'Affiliation': 'Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Varese', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Greenwood', 'Affiliation': 'Research and Development, Sussex Partnership NHS Foundation Trust, Brighton, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Steel', 'Affiliation': 'Oxford Centre for Psychological Health, Oxford Health NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Keen', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bowe', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Swan', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Underwood', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Longden', 'Affiliation': 'Complex Trauma and Resilience Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""Health Service & Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Potts', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Heslin', 'Affiliation': ""Health Service & Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Grey', 'Affiliation': 'Research and Development, Sussex Partnership NHS Foundation Trust, Brighton, UK.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Turkington', 'Affiliation': 'Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'Research and Development, Sussex Partnership NHS Foundation Trust, Brighton, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kuipers', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Complex Trauma and Resilience Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}]",Trials,['10.1186/s13063-022-06215-x']
1182,35608106,Targeting  FGFR3  alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial.,"PROOF 302 is an ongoing randomized, double-blind, placebo-controlled, adjuvant phase III trial (NCT04197986) in approximately 218 patients from 120 centers worldwide. Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bladder cancer (15%), susceptible  FGFR3  alterations (activating mutations, gene fusions or rearrangements), ≤120 days following radical surgery and ineligible for/or refusing cisplatin-based (neo)adjuvant chemotherapy. Patients receive either oral infigratinib 125 mg or placebo daily on days 1-21 of a 28-day cycle for up to 52 weeks or until recurrence, unacceptable toxicity or death. Primary end point: centrally determined disease-free survival (DFS); secondary end points: investigator-assessed DFS, metastasis-free survival, overall survival and safety/tolerability; exploratory end points: correlative biomarker analysis, quality-of-life and infigratinib pharmacokinetics.",2022,Primary end point: centrally determined disease-free survival (DFS);,"['Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bladder cancer (15%), susceptible  FGFR3  alterations (activating mutations, gene fusions or rearrangements), ≤120\xa0days following radical surgery and ineligible for/or refusing cisplatin-based (neo)adjuvant chemotherapy', 'approximately 218 patients from 120 centers worldwide', 'invasive urothelial carcinoma']","['oral infigratinib 125\xa0mg or placebo', 'placebo']","['disease-free survival (DFS', 'investigator-assessed DFS, metastasis-free survival, overall survival and safety/tolerability', 'correlative biomarker analysis, quality-of-life and infigratinib pharmacokinetics']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0527057', 'cui_str': 'FGFR3 protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0178648', 'cui_str': 'Gene Fusion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3254591', 'cui_str': '3-(2,6-dichloro-3,5-dimethoxyphenyl)-1-(6-(4-(4-ethylpiperazin-1-yl)-phenylamino)pyrimidin-4-yl)-1-methylurea'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3254591', 'cui_str': '3-(2,6-dichloro-3,5-dimethoxyphenyl)-1-(6-(4-(4-ethylpiperazin-1-yl)-phenylamino)pyrimidin-4-yl)-1-methylurea'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.705863,Primary end point: centrally determined disease-free survival (DFS);,"[{'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA 91010, USA.'}, {'ForeName': 'Diederik M', 'Initials': 'DM', 'LastName': 'Somford', 'Affiliation': 'Canisius Wilhelmina Hospital, 6532 SZ Nijmegen, The Netherlands.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Grivas', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Srikala S', 'Initials': 'SS', 'LastName': 'Sridhar', 'Affiliation': 'Princess Margaret Hospital, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH 44106, USA.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}, {'ForeName': 'Guru', 'Initials': 'G', 'LastName': 'Sonpavde', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA 02215, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fleming', 'Affiliation': 'Virginia Oncology Associates, Norfolk, VA 23502, USA.'}, {'ForeName': 'Seth P', 'Initials': 'SP', 'LastName': 'Lerner', 'Affiliation': 'Baylor College of Medicine, Houston, TX 77030, USA.'}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': 'Gustave Roussy, Villejuif, 94805, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hoffman-Censits', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD 21287, USA.'}, {'ForeName': 'Begoña P', 'Initials': 'BP', 'LastName': 'Valderrama', 'Affiliation': 'Hospital Universitario Virgen del Rocio, 41013 Seville, Spain.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Andresen', 'Affiliation': 'QED Therapeutics Inc., San Francisco, CA 94107, USA.'}, {'ForeName': 'Marco J', 'Initials': 'MJ', 'LastName': 'Schnabel', 'Affiliation': 'University of Regensburg, 93053 Regensburg, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': 'UT Southwestern Simmons Comprehensive Cancer Center, University of Texas, Dallas, TX 75390, USA.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Daneshmand', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA 90033, USA.'}]","Future oncology (London, England)",['10.2217/fon-2021-1629']
1183,35610657,Combined endoscopic and radiologic intervention for management of acute perforated peptic ulcer: a randomized controlled trial.,"BACKGROUND


Peptic ulcer perforation is a common life-threatening surgical emergency. Graham omental patch is performed for plugging of perforated peptic ulcer. Many endoscopic methods have been used to treat acute perforated peptic ulcer such as over the scope clips, standard endoscopic clips, endoscopic sewing and metallic stents. The main idea in endoscopic management of acute perforated peptic ulcer is early decontamination and decrease sepsis by interventional radiologic drainage.
METHODS


This is a prospective randomized controlled clinical trial. This study included patients who were developed acute perforated peptic ulcer manifestations and were admitted to our hospital between December 2019 and August 2021. Sample size was 100 patients divided into 2 equal groups. Endoscopic group (EG): included 50 patients who were subjected to endoscopic management. Surgical group (SG): included 50 patients who were subjected to surgical management.
RESULTS


One hundred patients were randomized into 2 groups: SG (50) and EG (50). Median age of patients was 36 (range 27:54) and 47 (range 41:50) years-old in SG and EG, respectively. Males constituted 72% and 66% in SG and EG, respectively. Median length of postoperative hospital stay was 1 (range: 1-2) days in EG, while in SG was 7 (range 6-8) days. Postoperative complications in SG patients were 58% in form of fever, pneumonia, leak, abdominal abscess, renal failure and incisional hernia (11%, 5%, 5%, 3%, 2% and 3%, respectively). Postoperative complications in EG patients were 24% in form of fever, pneumonia, leak, abdominal abscess, renal failure and incisional hernia (10%, 0%, 2%, 0%, 0% and 0%, respectively).
CONCLUSION


Combined endoscopic and interventional radiological drainage can effectively manage acute perforated peptic ulcer without the need for general anesthesia, with short operative time, in high risk surgical patients with low incidence of morbidity & mortality.",2022,"Postoperative complications in SG patients were 58% in form of fever, pneumonia, leak, abdominal abscess, renal failure and incisional hernia (11%, 5%, 5%, 3%, 2% and 3%, respectively).","['patients who were developed acute perforated peptic ulcer manifestations and were admitted to our hospital between December 2019 and August 2021', '50 patients who were subjected to surgical management', 'One hundred patients', '100 patients divided into 2 equal groups', 'acute perforated peptic ulcer', '50 patients who were subjected to endoscopic management', 'Median age of patients was 36 (range 27:54) and 47 (range 41:50) years-old in SG and EG, respectively']","['Combined endoscopic and interventional radiological drainage', 'Combined endoscopic and radiologic intervention', 'Graham omental patch']","['Postoperative complications', 'Median length of postoperative hospital stay', 'fever, pneumonia, leak, abdominal abscess, renal failure and incisional hernia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030925', 'cui_str': 'Peptic ulcer with perforation'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0028977', 'cui_str': 'Omental'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0243001', 'cui_str': 'Abdominal abscess'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}]",100.0,0.0406705,"Postoperative complications in SG patients were 58% in form of fever, pneumonia, leak, abdominal abscess, renal failure and incisional hernia (11%, 5%, 5%, 3%, 2% and 3%, respectively).","[{'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Negm', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt. said.negm@outlook.com.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Mohamed', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shafiq', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'AbdelKader', 'Affiliation': 'Sur Hospital, Ministry of Health, Muscat, Oman.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Ismail', 'Affiliation': 'Ismailia Teaching Oncology Hospital, Ismailia, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Yassin', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Mousa', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abozaid', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Yasser A', 'Initials': 'YA', 'LastName': 'Orban', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mazoun', 'Initials': 'M', 'LastName': 'Al Alawi', 'Affiliation': 'Ministry of Health, Muscat, Oman.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Farag', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",World journal of emergency surgery : WJES,['10.1186/s13017-022-00429-9']
1184,35611762,Short-term effects of modest salt reduction combined with DASH diet on changing salt eating habits in hypertensive patients with type II diabetes.,"OBJECTIVE


Excessive salt intake is currently the foremost universal risk factor for controllable chronic disease. This study evaluated the short-term effects of a modest salt intake reduction combined with the Chinese Modified Dietary Approaches to Stop Hypertension (CM-DASH) diet on sodium and potassium intake, mean arterial pressure (MAP), and pulse pressure (PP) in hypertensive patients with type II diabetes.
METHODS


Sixty-one participants were randomized to the intervention group (52% low-sodium salt and DASH) and control group (normal salt and DASH). An 8-week dietary intervention was applied. Daily salt intake, blood pressure (BP), and drug use were recorded every week. Twenty-four-hour urine, casual urine, and blood samples were measured at baseline, the 4th week, and the end of the intervention.
RESULTS


Fifty-nine patients (25 men) completed the entire study. Sodium intake decreased by 1259.66 (792.76, 1726.56)/705.80 (149.21, 1262.39) mg/day after 4 weeks (intervention: P < .001; control: P = .015). Potassium intake increased by 641.14 (73.31, 1208.96)/43.43 (-259.66, 346.53) mg/day (intervention:  P  = .028); MAP decreased by 9.06 (6.69, 11.43)/7.16 (4.03, 10.28) mmHg (both: P < .001); PP decreased by 7.97 (3.05, 12.88)/5.74 (2.55,8.94) mmHg (intervention: P = .002; control: P = .001) after 8 weeks. However, the difference between the two groups was not statistically significant.
CONCLUSION


Modest salt reduction and the CM-DASH diet for hypertensive patients with type II diabetes can achieve short-term salt reduction effects. The effect on changing salt-eating habits needs to be investigated with an extended follow-up.",2022,mg/day after 4 weeks (intervention: P < .001; control: P = .015).,"['Fifty-nine patients (25 men) completed the entire study', 'hypertensive patients with type II diabetes', 'Sixty-one participants']","['modest salt intake reduction combined with the Chinese Modified Dietary Approaches to Stop Hypertension (CM-DASH) diet', 'modest salt reduction combined with DASH diet', 'CM-DASH diet', 'intervention group (52% low-sodium salt and DASH) and control group (normal salt and DASH']","['salt eating habits', 'PP', 'Sodium intake', 'sodium and potassium intake, mean arterial pressure (MAP), and pulse pressure (PP', 'MAP', 'Potassium intake', 'Daily salt intake, blood pressure (BP), and drug use']","[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]",61.0,0.0109212,mg/day after 4 weeks (intervention: P < .001; control: P = .015).,"[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, School of Public Health and Management, Research Center for Medicine and Social Development, Innovation Center for Social Risk Governance in Health, Chongqing Medical University, Chongqing, SC, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Management, Research Center for Medicine and Social Development, Innovation Center for Social Risk Governance in Health, Chongqing Medical University, Chongqing, SC, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Gong', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health and Management, Chongqing Medical University, Chongqing, SC, China.'}, {'ForeName': 'Lisha', 'Initials': 'L', 'LastName': 'Mu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Management, Research Center for Medicine and Social Development, Innovation Center for Social Risk Governance in Health, Chongqing Medical University, Chongqing, SC, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Humanity and Art, School of Public Health and Management, Chongqing Medical University, Chongqing, SC, China.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Health Management Center of the Second Affiliated Hospital, Chongqing Medical University, Chongqing, SC, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department: Administrative Office, Chongqing Nan'an District People's Hospital, Chongqing, SC, China.""}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Bu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Management, Research Center for Medicine and Social Development, Innovation Center for Social Risk Governance in Health, Chongqing Medical University, Chongqing, SC, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Mu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Management, Research Center for Medicine and Social Development, Innovation Center for Social Risk Governance in Health, Chongqing Medical University, Chongqing, SC, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Mei', 'Affiliation': 'Health Management Center of the Second Affiliated Hospital, Chongqing Medical University, Chongqing, SC, China.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2022.2079666']
1185,35613672,Design and rationale for the treating obstructive sleep apnea using targeted hypoglossal neurostimulation (OSPREY) trial.,"Obstructive sleep apnea (OSA) affects nearly 1 billion people worldwide, including approximately 35 million US residents. OSA has detrimental cardiovascular and neurocognitive consequences. Positive airway pressure corrects sleep disordered breathing but is not always tolerated or used sufficiently. Oral appliances and surgery provide alternatives in select populations but are variably effective. Hypoglossal nerve stimulation can effectively treat obstructive sleep apnea. Targeted hypoglossal nerve stimulation (THN) is simpler than incumbent technology with no sensor and an easier, proximal electrode implantation. The third clinical study of THN, THN3, was the first randomized, controlled trial of hypoglossal nerve stimulation to demonstrate significant improvement of sleep disordered breathing in OSA. The present investigation reports the design of a novel trial of targeted stimulation to provide additional Level 1 evidence in moderate to severe obstructive apnea. OSPREY is a randomized, parallel-arm, 13-month trial wherein all subjects are implanted, 2/3 are activated at Month 1 (""Treatment"") and 1/3 are activated at Month 7 (""Control""). The primary endpoint is the difference in apnea-hypopnea index response rates between Treatment and Control groups at Month 7. Secondary endpoints include quality of life and oximetry metrics. OSPREY follows an adaptive ""Goldilocks"" design which optimizes the number of subjects with the need for high-confidence results. A maximum of 150 subjects is allowed, at which study power of >95% is predicted. Interim analyses begin once 50 patients are randomized and recur after each 20 additional randomizations to detect early success or futility. OSPREY is a unique, efficient trial that should provide high-confidence confirmation of the safety and efficacy of targeted hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea.",2022,The primary endpoint is the difference in apnea-hypopnea index response rates between Treatment and Control groups at Month 7.,"['moderate to severe obstructive apnea', '150 subjects']","['Hypoglossal nerve stimulation', 'Targeted hypoglossal nerve stimulation (THN', 'Positive airway pressure corrects sleep disordered breathing', 'OSA']","['obstructive sleep apnea', 'Obstructive sleep apnea (OSA', 'quality of life and oximetry metrics', 'apnea-hypopnea index response rates']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0020614', 'cui_str': 'Hypoglossal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",,0.0614767,The primary endpoint is the difference in apnea-hypopnea index response rates between Treatment and Control groups at Month 7.,"[{'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Jacobowitz', 'Affiliation': 'Sleep Department, ENT and Allergy Associates, New York, NY, United States of America. Electronic address: ojacobowitz@entandallergy.com.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Schwartz', 'Affiliation': 'Department of Otorhinolaryngology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania and Vanderbilt University School of Medicine, Nashville, TN, United States of America.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Lovett', 'Affiliation': 'Clinical and Medical Affairs, LivaNova PLC, Minneapolis, MN, United States of America.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Ranuzzi', 'Affiliation': 'Statistics and Data Management, LivaNova PLC, Milan, Italy.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, CA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106804']
1186,35617826,"Heterologous ChAdOx1/BNT162b2 vaccination induces stronger immune response than homologous ChAdOx1 vaccination: The pragmatic, multi-center, three-arm, partially randomized HEVACC trial.","BACKGROUND


Several COVID-19 vaccines have been approved. The mRNA vaccine from Pfizer/BioNTech (Comirnaty, BNT162b2; BNT) and the vector vaccine from AstraZeneca (Vaxzevria, ChAdOx1; AZ) have been widely used. mRNA vaccines induce high antibody and T cell responses, also to SARS-CoV-2 variants, but are costlier and less stable than the slightly less effective vector vaccines. For vector vaccines, heterologous vaccination schedules have generally proven more effective than homologous schedules.
METHODS


In the HEVACC three-arm, single-blinded, adaptive design study (ClinicalTrials.gov Identifier: NCT04907331), participants between 18 and 65 years with no prior history of SARS-CoV-2 infection and a first dose of AZ or BNT were included. The AZ/AZ and the AZ/BNT arms were randomized (in a 1:1 ratio stratified by sex and trial site) and single-blinded, the third arm (BNT/BNT) was observational. We compared the reactogenicity between the study arms and hypothesized that immunogenicity was higher for the heterologous AZ/BNT compared to the homologous AZ/AZ regimen using neutralizing antibody titers as primary endpoint.
FINDINGS


This interim analysis was conducted after 234 participants had been randomized and 254 immunized (N=109 AZ/AZ, N=115 AZ/BNZ, N=30 BNT/BNT). Heterologous AZ/BNT vaccination was well tolerated without study-related severe adverse events. Neutralizing antibody titers on day 30 were statistically significant higher in the AZ/BNT and the BNT/BNT groups than in the AZ/AZ group, for B.1.617.2 (Delta) AZ/AZ median reciprocal titer 75.9 (99.9% CI 58.0 - 132.5), AZ/BNT 571.5 (99.9% CI 396.6 - 733.1), and BNT/BNT 404.5 (99.9% CI 68.3 - 1024). Similarly, the frequency and multifunctionality of spike-specific T cell responses was comparable between the AZ/BNT and the BNT/BNT groups, but lower in the AZ/AZ vaccinees.
INTERPRETATION


This study clearly shows the immunogenicity and safety of heterologous AZ/BNT vaccination and encourages further studies on heterologous vaccination schedules.
FUNDING


This work was supported by the Medical University of Innsbruck, and partially funded by NIAID contracts No. 75N9301900065, 75N93021C00016, and 75N93019C00051.",2022,"Neutralizing antibody titers on day 30 were statistically significant higher in the AZ/BNT and the BNT/BNT groups than in the AZ/AZ group, for B.1.617.2 (Delta) AZ/AZ median reciprocal titer 75.9 (99.9% CI 58.0 - 132.5), AZ/BNT 571.5 (99.9% CI 396.6 - 733.1), and BNT/BNT 404.5 (99.9% CI 68.3 - 1024).","['Medical University of Innsbruck, and partially funded by NIAID contracts', '234 participants had been randomized and 254 immunized (N=109 AZ/AZ, N=115 AZ/BNZ, N=30 BNT/BNT', 'participants between 18 and 65 years with no prior history of SARS-CoV-2 infection and a first dose of AZ or BNT were included']","['Heterologous AZ/BNT vaccination', 'Heterologous ChAdOx1/BNT162b2 vaccination', 'heterologous AZ/BNT vaccination']","['reactogenicity', 'Neutralizing antibody titers', 'frequency and multifunctionality of spike-specific T cell responses', 'immunogenicity']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C1513895', 'cui_str': 'National Institute of Allergy and Infectious Diseases'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.208628,"Neutralizing antibody titers on day 30 were statistically significant higher in the AZ/BNT and the BNT/BNT groups than in the AZ/AZ group, for B.1.617.2 (Delta) AZ/AZ median reciprocal titer 75.9 (99.9% CI 58.0 - 132.5), AZ/BNT 571.5 (99.9% CI 396.6 - 733.1), and BNT/BNT 404.5 (99.9% CI 68.3 - 1024).","[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Bánki', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Mateus', 'Affiliation': 'Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology (LJI), La Jolla, CA 92037, USA.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Rössler', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Schäfer', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bante', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Riepler', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Grifoni', 'Affiliation': 'Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology (LJI), La Jolla, CA 92037, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sette', 'Affiliation': 'Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology (LJI), La Jolla, CA 92037, USA; Department of Medicine, Division of Infectious Diseases and Global Public Health, University of California, San Diego (UCSD), La Jolla, CA 92037, USA.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Simon', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; The Global Health and Emerging Pathogen Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Falkensammer', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Ulmer', 'Affiliation': 'Department of Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Neurauter', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria.'}, {'ForeName': 'Wegene', 'Initials': 'W', 'LastName': 'Borena', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krammer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Electronic address: florian.krammer@mssm.edu.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'von Laer', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria. Electronic address: dorothee.von-laer@i-med.ac.at.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weiskopf', 'Affiliation': 'Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology (LJI), La Jolla, CA 92037, USA. Electronic address: daniela@lji.org.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Kimpel', 'Affiliation': 'Institute of Virology, Department of Hygiene, Microbiology and Public Health, Medical University of Innsbruck, Peter-Mayr-Str. 4b, 6020 Innsbruck, Austria. Electronic address: janine.kimpel@i-med.ac.at.'}]",EBioMedicine,['10.1016/j.ebiom.2022.104073']
1187,35617820,Pre-sintering pigmentation techniques do not affect the fatigue behavior of adhesively luted 4YSZ restorations.,"This study aims to characterize the effect of shading techniques on the fatigue behavior of a 4YSZ ceramic (4 mol% yttrium stabilized zirconia) adhesively bonded to a dentin analogue (fiber-reinforced epoxy resin). 4YSZ ceramic discs (IPS e.max ZirCAD, Ø = 10 mm and 1 mm of thickness) were allocated according to the factor 'shading technique' into 4 groups: Brush- unshaded ceramic disc (IPS e.max ZirCAD BL) pigmented at the pre-sintered stage with pigment solution applied manually using a round liner brush; Immersion- unshaded ceramic disc pigmented through immersion in the solution for 1 s on only one side of the ceramic disc; Manufacturer- specimens already shaded by the manufacturer (IPS e.max ZirCAD MT A2 - Manufacturer group); Control- a control condition with absence of pigment (i.e. non-pigmented specimens). The specimens were sintered and a spectrophotometer (SP60, EX- Rite) was used to ensure that the same perceived color (i.e. pigment saturation) was achieved in the different shading strategies (Manufacturer, Brush or Immersion groups). To do so, the color differences (ΔE 00 ) were calculated using the CIEDE 2000 equation; and an ΔE 00  of up to 1.77 was considered as an acceptability threshold. Dentin analogue discs were obtained (Ø = 10 mm and 2.5 mm of thickness) and randomly allocated into pairs with the 4YSZ ceramic discs. Next, the pairs were adhesively bonded using a resin cement (Multilink N). The bonded assemblies (n = 15) were tested for fatigue using the step-stress test method (frequency of 20 Hz; 10,000 cycles per step, initial load 200 N; step-size of 100 N, up to 700 N; and after, step-size of 50 N, until specimen failure/fracture or radial cracks). Fatigue failure load (FFL) and number of cycles for failure (CFF) were recorded for statistical analysis. Fractographic features were accessed, and complementary roughness, topography, grain size and phase content analyses were performed. No statistical differences were observed in the fatigue behavior among the non-shaded condition (Control group - 880 N) and the shaded specimens (Manufacturer - 887 N, Brush - 820 N, and Immersion - 850 N groups; p > 0.05). However, the use of a brush shading technique induced slightly inferior fatigue mechanical behavior of the restorative set compared to the specimens already shaded by the manufacturer (p = 0.027). No differences in Weibull modulus were observed among the tested groups. The specimens pigmented by the brush technique demonstrated a rougher surface, with statistically higher Rz values, in addition to a larger grain size in comparison to all other conditions (p< 0.05). No m-phase content was identified (only t and c phases were detected). Thus, the shading techniques used to provide a Vita classic A2 shade does not negatively affect the mechanical fatigue properties of a bonded 4YSZ ceramic. However, the brush technique has detrimental effect on the fatigue behavior compared to when the ceramic was already provided in a shaded format by its manufacturer.",2022,"No statistical differences were observed in the fatigue behavior among the non-shaded condition (Control group - 880 N) and the shaded specimens (Manufacturer - 887 N, Brush - 820 N, and Immersion - 850 N groups; p > 0.05).",[],"['4YSZ ceramic discs', 'ZirCAD BL', 'Brush- unshaded ceramic disc (IPS e.max', '4YSZ ceramic (4\xa0mol% yttrium stabilized zirconia', '4YSZ ceramic discs (IPS e.max']","['Weibull modulus', 'Fatigue failure load (FFL) and number of cycles for failure (CFF', 'Rz values', 'Dentin analogue discs', 'mechanical fatigue properties', 'fatigue behavior', 'inferior fatigue mechanical behavior']",[],"[{'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]",15.0,0.043464,"No statistical differences were observed in the fatigue behavior among the non-shaded condition (Control group - 880 N) and the shaded specimens (Manufacturer - 887 N, Brush - 820 N, and Immersion - 850 N groups; p > 0.05).","[{'ForeName': 'Luiza Freitas Brum', 'Initials': 'LFB', 'LastName': 'Souza', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: luizafbrum@hotmail.com.'}, {'ForeName': 'Rafaela Oliveira', 'Initials': 'RO', 'LastName': 'Pilecco', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: rafaela-pilecco@hotmail.com.'}, {'ForeName': 'Valentina Soares', 'Initials': 'VS', 'LastName': 'Menna Barreto', 'Affiliation': 'Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valentinamennabarreto@gmail.com.'}, {'ForeName': 'Gratcheva Falcão', 'Initials': 'GF', 'LastName': 'Chiapinotto', 'Affiliation': 'Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: gratcheva@hotmail.com.'}, {'ForeName': 'Natália de Freitas', 'Initials': 'NF', 'LastName': 'Daudt', 'Affiliation': 'MSciEng and PhD Post-Graduate Program in Mechanical Engineering, Faculty of Mechanical Engineering, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: natalia.daudt@ufsm.br.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2022.105270']
1188,35617770,Cardiometabolic measures and cognition in early menopause - Analysis of baseline data from a randomized controlled trial.,"OBJECTIVE


The relationships between cardiometabolic indices and cognition were examined in recently menopausal women.
METHODS


Cross-sectional analysis of baseline data from the KEEPS (Kronos Early Estrogen Prevention Study)-Cognitive ancillary study (n = 621). Cognitive performance was assessed by the Modified Mini Mental Status (3MS) score (primary outcome). Physical cardiometabolic indices included body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), and blood pressure (BP). Biochemical cardiometabolic indices included serum levels of high sensitivity C-reactive protein (hs-CRP), total cholesterol (TC), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C), non-HDL (non-HDL-C), triglycerides (TG), fasting serum glucose (FSG), and insulin resistance (HOMA-IR). Socio-demographic variables included age, race/ethnicity, education, and lifestyle (physical activity, smoking). Central adiposity was defined as WC > 88 cm (>35 in) and WHR > 0.8. Separate stepwise multivariable analyses (GLM, ordinal logistic regression and logistic regression) assessed relationships between 3MS scores (as continuous, in tertiles and dichotomized at 90 respectively) with the measures of central adiposity (predictor variables); socio-demographic variables (age, time since menopause, race, educational status and lifestyle) and cardiometabolic variables (BP, lipids, FSG, HOMA-IR and hs-CRP) were examined as covariates. The final multivariable models included time since menopause, race, ethnicity, educational status, strenuous exercise, BMI ≥30 kg/m 2 , non-HDL-C and hs-CRP as covariates. Due to the high collinearity between the two indices of central adiposity, within each analytic strategy, separate models examined the respective associations of WC > 88 cm and WHR > 0.8 with 3MS score.
RESULTS


On adjusted analyses, indices of central adiposity were independent predictors of significantly lower 3MS scores (p < 0.05). Consistency in this relationship was observed across the three different multivariable regression analytic approaches (GLM, ordinal and logistic regression).
CONCLUSIONS


Among recently menopausal women, WC > 88 cm and WHR > 0.8 were associated with significantly lower cognitive function, as reflected by lower 3MS scores. The mechanisms that might explain the observed negative implications of central adiposity for cognitive function warrant further study.",2022,"On adjusted analyses, indices of central adiposity were independent predictors of significantly lower 3MS scores (p < 0.05).",['menopausal women'],['KEEPS '],"['Physical cardiometabolic indices included body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), and blood pressure (BP', 'Cognitive performance', 'cognitive function', '3MS scores', 'serum levels of high sensitivity C-reactive protein (hs-CRP), total cholesterol (TC), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C), non-HDL (non-HDL-C), triglycerides (TG), fasting serum glucose (FSG), and insulin resistance (HOMA-IR', 'time since menopause, race, ethnicity, educational status, strenuous exercise, BMI ≥30\xa0kg/m 2 , non-HDL-C and hs-CRP as covariates', 'central adiposity', 'Central adiposity', 'central adiposity (predictor variables); socio-demographic variables (age, time since menopause, race, educational status and lifestyle) and cardiometabolic variables (BP, lipids, FSG, HOMA-IR and hs-CRP', 'Modified Mini Mental Status (3MS) score']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0333118', 'cui_str': 'Retained'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4551560', 'cui_str': 'Central obesity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}]",,0.103467,"On adjusted analyses, indices of central adiposity were independent predictors of significantly lower 3MS scores (p < 0.05).","[{'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Pal', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, Yale University School of Medicine, New Haven, CT, United States. Electronic address: lubna.pal@yale.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Morgan', 'Affiliation': 'SSM Health Dean Medical Group, Madison, WI, United States.'}, {'ForeName': 'Nanette F', 'Initials': 'NF', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics, Gynecology, University of Colorado, Denver, United States.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, United States.""}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, Yale University School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Mayo Clinic, United States; Department of Physiology and Biomedical Engineering, Mayo Clinic, United States.'}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': 'Utah Lipid Center, United States.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Lobo', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, United States.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Neal-Perry', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, UCSF, United States.'}, {'ForeName': 'S Mitchell', 'Initials': 'SM', 'LastName': 'Harman', 'Affiliation': 'Kronos Longevity Research Institute and the Phoenix Veterans Administration Health Care System, Phoenix, AZ, United States.'}, {'ForeName': 'Taryn T', 'Initials': 'TT', 'LastName': 'James', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison Geriatric Research Education and Clinical Center (GRECC), United States.'}, {'ForeName': 'Carey E', 'Initials': 'CE', 'LastName': 'Gleason', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison Geriatric Research Education and Clinical Center (GRECC), United States.'}]",Maturitas,['10.1016/j.maturitas.2022.04.004']
1189,35617742,"Intranasal oxytocin alters attention to emotional facial expressions, particularly for males and those with depressive symptoms.","Intranasal oxytocin (OT) can enhance emotion recognition, perhaps by promoting increased attention to social cues. Some studies indicate that individuals with difficulties processing social information, including those with psychopathology, show more pronounced effects in response to OT. As such, there is interest in the potential therapeutic use of OT in populations with deficits in social cognition. The present study examined the effects of intranasal OT on the processing of facial features and selective attention to emotional facial expressions, as well as whether individual differences in depressive symptom severity predict sensitivity to intranasal OT. In a double-blind placebo-controlled within-subject design, eye tracking was used to measure attention to facial features in an emotional expression appraisal task, and attention to emotional expressions in a free-viewing task with a quadrant of multiple faces. OT facilitated the processing of positive cues, enhancing the maintenance of attention to the mouth region of happy faces and to happy faces within a quadrant, with similar effect sizes, despite the latter effect not being statistically significant. Further, persons with depressive symptoms, and particularly males, were sensitive to OT's effects. For males only, OT, relative to placebo, increased attentional focus to the mouth region of all faces. Individuals with depressive symptoms showed less attentional focus on angry (males only) and sad facial expressions, and more attention to happy faces (particularly for males). Results indicate increased sensitivity to OT in males and persons at risk for depression, with OT administration promoting a positive bias in selective attention to social stimuli.",2022,"Individuals with depressive symptoms showed less attentional focus on angry (males only) and sad facial expressions, and more attention to happy faces (particularly for males).","['males and those with depressive symptoms', 'males and persons at risk for depression', 'persons with depressive symptoms, and particularly males', 'Individuals with depressive symptoms']","['placebo', 'Intranasal oxytocin', 'Intranasal oxytocin (OT', 'intranasal OT']","['sensitivity to OT', 'emotional facial expressions', 'processing of facial features and selective attention to emotional facial expressions']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}]",,0.0620236,"Individuals with depressive symptoms showed less attentional focus on angry (males only) and sad facial expressions, and more attention to happy faces (particularly for males).","[{'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Boyle', 'Affiliation': 'Department of Psychology, Concordia University, Canada. Electronic address: ariel.boyle@mail.concordia.ca.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, Concordia University, Canada. Electronic address: aaron.johnson@concordia.ca.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ellenbogen', 'Affiliation': 'Department of Psychology, Concordia University, Canada. Electronic address: mark.ellenbogen@concordia.ca.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2022.105796']
1190,35619283,Analysis of respiratory muscle strength and its relationship with functional capacity between different field tests in patients with heart failure.,"OBJECTIVE


To analyze respiratory muscle strength of patients with heart failure (HF) and correlate with functional capacity.
METHODS


This cross-sectional study involved patients with compensated HF of both sexes, aged above 18 years. Respiratory muscle strength was assessed by measuring maximum inspiratory (MIP) and expiratory pressures (MEP) using a manovacuometer. Patients were randomized into two groups to assess functional capacity: six-minute walk test (6MWT) and incremental shuttle walk test (ISWT).
RESULTS


Forty-eight patients were evaluated (23 from 6MWT and 25 from ISWT group). Most were male (67.8%), with mean age of 62.3 years and left ventricular ejection fraction of 40.8%. Mean predicted values of MIP [81.2% (74.7-87.8%)] and MEP [95.6% (88.2-103.0%)] did not indicate respiratory muscle weakness. The higher the New York Heart Association (NYHA) functional class, the lower the MIP (p = .011) and MEP (p = .016) values. Physically active patients presented higher respiratory muscle strength than those sedentary (MIP: 104.5 vs. 71.9 cmH 2 O, p < .001; MEP: 120.0 vs. 91.1 cmH 2 O, p = .004). Functional capacity was impaired [6MWT: 416.0 m (372.8-459.3 m); ISWT: 304 m (263.4-344.9 m)], and distance covered in the ISWT was shorter than 6MWT group (p < .001). Distance covered in the ISWT group presented a moderate positive correlation with MIP (r = 0.45; p = .022) and MEP (r = 0.41; p = .041).
CONCLUSION


Most patients with HF presented respiratory muscle strength close to predicted values; however, sedentary patients and those with high NYHA functional class, showed reduced MIP and MEP. Functional capacity was reduced, and MIP and MEP correlated with distance covered in the ISWT.",2022,Functional capacity was impaired,"['patients with compensated HF of both sexes, aged above 18\xa0years', 'Forty-eight patients were evaluated (23 from 6MWT and 25 from ISWT group', 'patients with heart failure', 'Most were male (67.8%), with mean age of 62.3\xa0years and left ventricular ejection fraction of 40.8', 'patients with heart failure (HF']","['functional capacity: six-minute walk test (6MWT) and incremental shuttle walk test (ISWT', 'ISWT']","['Respiratory muscle strength', 'respiratory muscle strength', 'Functional capacity', 'MEP', 'Mean predicted values of MIP', 'MIP and MEP', 'maximum inspiratory (MIP) and expiratory pressures (MEP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}]","[{'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",48.0,0.0454646,Functional capacity was impaired,"[{'ForeName': 'Nina de Souza', 'Initials': 'NS', 'LastName': 'Silva Andrade', 'Affiliation': 'Department of Biological Sciences and Health, Physiotherapy Course, Cardiovascular and Respiratory Physiotherapy Laboratory, Federal University of Amapá, Macapá - Amapá, Brazil.'}, {'ForeName': 'Larisse', 'Initials': 'L', 'LastName': 'Almeida', 'Affiliation': 'Department of Biological Sciences and Health, Physiotherapy Course, Cardiovascular and Respiratory Physiotherapy Laboratory, Federal University of Amapá, Macapá - Amapá, Brazil.'}, {'ForeName': 'Isis', 'Initials': 'I', 'LastName': 'Noronha', 'Affiliation': 'Department of Biological Sciences and Health, Physiotherapy Course, Cardiovascular and Respiratory Physiotherapy Laboratory, Federal University of Amapá, Macapá - Amapá, Brazil.'}, {'ForeName': 'José de Morais', 'Initials': 'JM', 'LastName': 'Lima', 'Affiliation': 'Department of Physiotherapy, Laboratory of Physiotherapy in Cardiorespiratory Research, Federal University of Paraíba, Campus I - Loteamento Cidade Universitária, João Pessoa - Paraíba, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Eriko Tenório de França', 'Affiliation': 'Department of Physiotherapy, Laboratory of Physiotherapy in Cardiorespiratory Research, Federal University of Paraíba, Campus I - Loteamento Cidade Universitária, João Pessoa - Paraíba, Brazil.'}, {'ForeName': 'Rafaela', 'Initials': 'R', 'LastName': 'Pedrosa', 'Affiliation': 'Department of Physiotherapy, Laboratory of Physiotherapy in Cardiorespiratory Research, Federal University of Paraíba, Campus I - Loteamento Cidade Universitária, João Pessoa - Paraíba, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Siqueira', 'Affiliation': 'Department of Biological Sciences and Health, Physiotherapy Course, Cardiovascular and Respiratory Physiotherapy Laboratory, Federal University of Amapá, Macapá - Amapá, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Onofre', 'Affiliation': 'Department of Biological Sciences and Health, Physiotherapy Course, Cardiovascular and Respiratory Physiotherapy Laboratory, Federal University of Amapá, Macapá - Amapá, Brazil.'}]",Physiotherapy theory and practice,['10.1080/09593985.2022.2077270']
1191,35623017,Evaluating the effects of gratitude interventions on college student well-being.,"Objective:  To evaluate the effects of three different gratitude interventions on college student well-being.  Participants:  Participants were 132 college students at a university in the northwest sampled between September 2019 and February 2020.  Methods:  Participants were randomly assigned to one of three gratitude interventions (journaling, reflection, app prompted reflection) or an activity-matched control group for 8 weeks and completed baseline and post-intervention assessments of well-being (e.g., satisfaction with life, happiness, resilience, depression, anxiety, and stress).  Results:  Participants in all three gratitude intervention groups showed improvements in well-being over time, whereas the control group did not report any such improvements. Gratitude journaling appeared to have the most significant positive impact on well-being and affective functioning.  Conclusions:  Gratitude interventions are simple, easy to implement, low-cost tools that can increase overall well-being and decrease negative affect, stress, and anxiety in college students.",2022,"Gratitude interventions are simple, easy to implement, low-cost tools that can increase overall well-being and decrease negative affect, stress, and anxiety in college students.","['college student well-being', '132 college students at a university in the northwest sampled between September 2019 and February 2020', 'Participants:  Participants', 'college students']","['gratitude interventions (journaling, reflection, app prompted reflection) or an activity-matched control group for 8\u2009weeks and completed baseline and post-intervention assessments of well-being', 'gratitude interventions']","['satisfaction with life, happiness, resilience, depression, anxiety, and stress', 'well-being over time']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0475815,"Gratitude interventions are simple, easy to implement, low-cost tools that can increase overall well-being and decrease negative affect, stress, and anxiety in college students.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Tolcher', 'Affiliation': 'Department of Psychological Sciences, University of Portland, Portland, Oregon, USA.'}, {'ForeName': 'Madalyn', 'Initials': 'M', 'LastName': 'Cauble', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Downs', 'Affiliation': 'Department of Psychological Sciences, University of Portland, Portland, Oregon, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2022.2076096']
1192,35603703,Knowing When to Pass: The Effect of AI Reliability in Risky Decision Contexts.,"OBJECTIVE


This study manipulates the presence and reliability of AI recommendations for risky decisions to measure the effect on task performance, behavioral consequences of trust, and deviation from a probability matching collaborative decision-making model.
BACKGROUND


Although AI decision support improves performance, people tend to underutilize AI recommendations, particularly when outcomes are uncertain. As AI reliability increases, task performance improves, largely due to higher rates of compliance (following action recommendations) and reliance (following no-action recommendations).
METHODS


In a between-subject design, participants were assigned to a high reliability AI, low reliability AI, or a control condition. Participants decided whether to bet that their team would win in a series of basketball games tying compensation to performance. We evaluated task performance (in accuracy and signal detection terms) and the behavioral consequences of trust (via compliance and reliance).
RESULTS


AI recommendations improved task performance, had limited impact on risk-taking behavior, and were under-valued by participants. Accuracy, sensitivity ( d' ), and reliance increased in the high reliability AI condition, but there was no effect on response bias ( c ) or compliance. Participant behavior was only consistent with a probability matching model for compliance in the low reliability condition.
CONCLUSION


In a pay-off structure that incentivized risk-taking, the primary value of the AI recommendations was in determining when to perform no action (i.e., pass on bets).
APPLICATION


In risky contexts, designers need to consider whether action or no-action recommendations will be more influential to design appropriate interventions.",2022,"Accuracy, sensitivity ( d' ), and reliance increased in the high reliability AI condition, but there was no effect on response bias ( c ) or compliance.",[],[],"['task performance', ""Accuracy, sensitivity ( d' ), and reliance"", 'response bias ( c ) or compliance', 'risk-taking behavior']",[],[],"[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0290627', 'cui_str': 'Reliance resin cement'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0507136,"Accuracy, sensitivity ( d' ), and reliance increased in the high reliability AI condition, but there was no effect on response bias ( c ) or compliance.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Elder', 'Affiliation': 'Technische Universität Berlin, Berlin, Germany, and University of Missouri-Columbia, Columbia, Missouri, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Canfield', 'Affiliation': 'Missouri University of Science & Technology, Rolla, Missouri, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Shank', 'Affiliation': 'Missouri University of Science & Technology, Rolla, Missouri, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Rieger', 'Affiliation': 'Technische Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Hines', 'Affiliation': 'Missouri University of Science & Technology, Rolla, Missouri, USA.'}]",Human factors,['10.1177/00187208221100691']
1193,35604745,Marriage checkup in integrated primary care: A randomized controlled trial with active-duty military couples.,"OBJECTIVE


This study assessed the efficacy of the marriage checkup, as adapted to integrated primary care settings and active-duty military couples, for improving relationship health and depressive symptoms.
METHOD


Married couples (N = 244, Mage = 32.4, 67.6% Caucasian) in which at least one member was active-duty Air Force were recruited from bases across the U.S. via online advertisement, emails sent from medical clinics to enrolled beneficiaries, social media posts, and flyers, and randomly assigned to active treatment or waitlist control. Treatment and control couples were linked in pairs sequentially and pairs completed nine sets of questionnaires at baseline, 1-, and 6-month posttreatment. Outcome measures included the Couples Satisfaction Index, Intimate Safety Questionnaire, Responsive Attention Scale, Partner Compassion Scale, Communication Skills Test, and the Center for Epidemiologic Studies Depression Scale.
RESULTS


A three-level multilevel model indicated, after adjustment for multiple comparisons, treatment couples experienced statistically significant small-to-moderate improvements compared to the control group (Cohen's d from 0.21 to 0.55) at 1 month that were sustained at 6 months for relationship satisfaction, responsive attention, compassion toward their partners, communication skills, intimate safety, and depressive symptoms.
CONCLUSIONS


A longitudinal randomized control trial of the MC supports the hypothesis that the MC significantly improves relationship satisfaction, intimacy, communication, partner compassion, responsive attention, and depressive symptoms. Implications for theory, treatment, and dissemination are discussed. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"Outcome measures included the Couples Satisfaction Index, Intimate Safety Questionnaire, Responsive Attention Scale, Partner Compassion Scale, Communication Skills Test, and the Center for Epidemiologic Studies Depression Scale.
","['Married couples (N = 244, Mage = 32.4, 67.6% Caucasian) in which at least one member was active-duty Air Force were recruited from bases across the U.S. via online advertisement, emails sent from medical clinics to enrolled beneficiaries, social media posts, and flyers']","['MC', 'active treatment or waitlist control']","['relationship satisfaction, responsive attention, compassion toward their partners, communication skills, intimate safety, and depressive symptoms', 'relationship satisfaction, intimacy, communication, partner compassion, responsive attention, and depressive symptoms', 'Couples Satisfaction Index, Intimate Safety Questionnaire, Responsive Attention Scale, Partner Compassion Scale, Communication Skills Test, and the Center for Epidemiologic Studies Depression Scale']","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office""}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.106327,"Outcome measures included the Couples Satisfaction Index, Intimate Safety Questionnaire, Responsive Attention Scale, Partner Compassion Scale, Communication Skills Test, and the Center for Epidemiologic Studies Depression Scale.
","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cigrang', 'Affiliation': 'School of Professional Psychology.'}, {'ForeName': 'James V', 'Initials': 'JV', 'LastName': 'Cordova', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Tatiana D', 'Initials': 'TD', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Fedynich', 'Affiliation': 'School of Professional Psychology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Maher', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Abby N', 'Initials': 'AN', 'LastName': 'Diehl', 'Affiliation': 'Wilford Hall Ambulatory Services Center.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hawrilenko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000734']
1194,35605807,Patients with transplantation have reduced mortality in bacteraemia: Analysis of data from a randomised trial.,"OBJECTIVES


Infection remains a major complication of organ transplantation. Paradoxically, epidemiological studies suggest better survival from serious infection. We analysed the relationship between organ transplantation and short -term mortality of patients with bloodstream infection.
METHODS


Data on transplantation status was extracted from a large prospective, multi-centre clinical trial in bloodstream infection. Logistic regression for 28-day mortality was performed on the whole cohort and a propensity-matched cohort (3:1). Infective pathogen, focus of infection, and clinical variables were included in the model. Mediation analysis was performed on clinical variables to explore causation.
RESULTS


4,178 participants were included in the full cohort, with 868 in the matched cohort, of which 217 received an organ transplant. Haematopoietic stem cell transplants (HSCT) were the most common transplant (n = 99), followed by kidney (n = 70). The most common pathogens were staphylococci and Enterobacterales. Transplantation status was associated with a reduced mortality in both the whole (Odds Ratio, OR 0.53; 95% CI 0.28, 0.77) and matched (OR 0.55, 95% CI 0.34, 0.90) cohort, while steroid use was robustly associated with increased mortality OR 4.4 (95% CI 3.12, 6.20) in the whole cohort and OR 5.24 (95% CI 2.79, 9.84) in the matched cohort. There was no interaction between steroid use and transplant status, so transplant patients on steroids generally had increased mortality relative to those without either.
CONCLUSIONS


Organ transplantation is associated with a near halving of short term mortality in bloodstream infection, including a cohort matched for comorbidities, infective pathogen and focus. Steroid usage is associated with increased mortality regardless of transplant status. Understanding the mechanism and causation of this mortality benefit should be a focus of future research.",2022,"Transplantation status was associated with a reduced mortality in both the whole (Odds Ratio, OR 0.53; 95% CI 0.28, 0.77) and matched (OR 0.55, 95% CI 0.34, 0.90) cohort, while steroid use was robustly associated with increased mortality OR 4.4 (95% CI 3.12, 6.20) in the whole cohort and OR 5.24 (95% CI 2.79, 9.84) in the matched cohort.","['4,178 participants were included in the full cohort, with 868 in the matched cohort, of which 217 received an organ transplant', 'patients with bloodstream infection', 'Data on transplantation status was extracted from a large prospective, multi-centre clinical trial in bloodstream infection', 'Patients with transplantation have reduced mortality in bacteraemia']",['Haematopoietic stem cell transplants (HSCT'],"['mortality relative', 'mortality OR', 'reduced mortality']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}]","[{'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",4178.0,0.230312,"Transplantation status was associated with a reduced mortality in both the whole (Odds Ratio, OR 0.53; 95% CI 0.28, 0.77) and matched (OR 0.55, 95% CI 0.34, 0.90) cohort, while steroid use was robustly associated with increased mortality OR 4.4 (95% CI 3.12, 6.20) in the whole cohort and OR 5.24 (95% CI 2.79, 9.84) in the matched cohort.","[{'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Hamilton', 'Affiliation': 'Infection Sciences, Pathology, North Bristol NHS Trust, Bristol, United Kingdom; Population Health Sciences, University of Bristol, Bristol, United Kingdom; Project Sepsis, Cardiff University, Cardiff, United Kingdom. Electronic address: fergus.hamilton@bristol.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ghazal', 'Affiliation': 'Project Sepsis, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'MacGowan', 'Affiliation': 'Infection Sciences, Pathology, North Bristol NHS Trust, Bristol, United Kingdom.'}]",The Journal of infection,['10.1016/j.jinf.2022.05.014']
1195,35606229,"Effect of exercises according to the circadian rhythm in type 2 diabetes: Parallel-group, single-blind, crossover study.","BACKGROUND AND AIM


To evaluate the effectiveness of structured exercise appropriate the circadian rhythm in terms of blood sample test (BST), functionality and quality of life (QoL) in individuals with type 2 diabetes.
METHODS AND RESULTS


This was a parallel-group, single-blind, crossover study. Thirty individuals with type 2 diabetes aged 35-65 years were enrolled in the study and allocated into 2 groups as the Morning Chronotype (MC) Group (n = 15) and the Evening Chronotype (EC) Group (n = 15) using Morningness-Eveningness Questionnaire which was used to determine the chronotypes. Participants were evaluated in terms of BST, functionality and QoL at the beginning of the study (T0), at 6 (T1), 12 (T2), and 18 (T3) weeks after the study started. A structured exercise program for 3 days a week over 6 weeks was applied in accordance with the chronotypes (T1-T2) and cross-controlled for the chronotypes (T2-T3). Significant differences were found in favor of the exercise given at the appropriate time for the chronotype in all parameters in both groups within groups (T0-T1-T2-T3) (p < 0.05). In the time∗group interactions, exercise in accordance with the appropriate chronotype in both groups provided the highest statistical improvement in all parameters (p < 0.05).
CONCLUSION


It was concluded that structured exercise performed at the appropriate time for chronotype improves HbA 1c , fasting blood glucose, HDL-LDL cholesterol, triglyceride, total cholesterol, functionality and quality of life in type 2 diabetes. This variation in blood values was observed to reflect the quantitative effects of exercise administered according to the circadian rhythm in individuals with type 2 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT04427488). The protocol of the study was registered at ClinicalTrials.gov (NCT04427488).",2022,"In the time∗group interactions, exercise in accordance with the appropriate chronotype in both groups provided the highest statistical improvement in all parameters (p < 0.05).
","['Thirty individuals with type 2 diabetes aged 35-65 years', 'individuals with type 2 diabetes', 'type 2 diabetes']","['exercises', 'Morning Chronotype (MC) Group (n\xa0=\xa015) and the Evening Chronotype (EC) Group (n\xa0=\xa015) using Morningness-Eveningness Questionnaire', 'structured exercise appropriate the circadian rhythm']","['blood values', 'HbA 1c , fasting blood glucose, HDL-LDL cholesterol, triglyceride, total cholesterol, functionality and quality of life', 'BST, functionality and QoL', 'blood sample test (BST), functionality and quality of life (QoL']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",30.0,0.0365969,"In the time∗group interactions, exercise in accordance with the appropriate chronotype in both groups provided the highest statistical improvement in all parameters (p < 0.05).
","[{'ForeName': 'Merve Yilmaz', 'Initials': 'MY', 'LastName': 'Menek', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Science, Istanbul Medipol University, Istanbul, Turkey. Electronic address: merveyilmaz@medipol.edu.tr.'}, {'ForeName': 'Miray', 'Initials': 'M', 'LastName': 'Budak', 'Affiliation': 'Department of Ergotherapy, Faculty of Health Science, Istanbul Medipol University, Istanbul, Turkey. Electronic address: mbudak@medipol.edu.tr.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2022.04.017']
1196,35606227,"Effect of Atkins versus a low-fat diet on gut microbiota, and cardiometabolic markers in obese women following an energy-restricted diet: Randomized, crossover trial.","BACKGROUND AND AIMS


There is controversy about effects of the Atkins diet on cardiometabolic markers in previous studies. No study compared effects of Atkins versus a low-fat diet on gut microbiota in obese women during a weight-loss program up to date.
METHODS AND RESULTS


A 6-week, randomized, crossover trial was conducted. Twenty-four healthy women with obesity (BMI≥30 kg/m 2 ) were randomly assigned to receive the Atkins (55%, 25%, and 20% of total daily calories from fat, protein, and carbohydrates), or low-fat (20%, 15%, and 65% of total daily calories from fat, protein, and carbohydrates) diets while following a weight-loss program. Vegetable oils were used as the main source of dietary fat. Dietary groups were switched after two weeks of washout period with a weight maintenance low-fat diet. The effects of the two diets did not differ for the most endpoints. However, Gut Actinobacteria residency and serum total antioxidant capacity significantly increased in the Akins diet group compared with the low-fat one (p = 0.02 and p = 0.04). Adjusting for all parameters, gut Actinobacteria residency 1.48- and 2.5-folds decreased the serum LDL.C/HDL.C ratio and non-HDL.C levels (95%CI: 3.1, -0.22; p = 0.03 and -0.07, -0.002; p = 0.04), respectively. Decrease in gut Proteobacteria residency showed a significant reduction in serum total oxidant status (95%CI: 7.4, -0.07; p = 0.04).
CONCLUSIONS


The Atkins diet, based on vegetable oils, alters gut microbiota composition, atherogenic and antioxidant parameters.
REGISTRATION NUMBER FOR CLINICAL TRIAL


IRCT20200929048876N3.",2022,"Decrease in gut Proteobacteria residency showed a significant reduction in serum total oxidant status (95%CI: 7.4, -0.07; p = 0.04).
","['obese women during a weight-loss program up to date', 'Twenty-four healthy women with obesity (BMI≥30\xa0kg/m 2 ', 'obese women following an energy-restricted diet']","['Atkins diet', 'Atkins versus a low-fat diet']","['serum total oxidant status', 'Gut Actinobacteria residency and serum total antioxidant capacity', 'cardiometabolic markers', 'serum LDL.C/HDL.C ratio and non-HDL.C levels', 'gut microbiota', 'gut microbiota, and cardiometabolic markers']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0600148', 'cui_str': 'Class Actinobacteria'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",24.0,0.0279528,"Decrease in gut Proteobacteria residency showed a significant reduction in serum total oxidant status (95%CI: 7.4, -0.07; p = 0.04).
","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Haji-Ghazi Tehrani', 'Affiliation': 'Department of Internal Medicine, Vali-e asr Hospital, Zanjan University of Medical Science, Zanjan, Iran; Zanjan Metaboilc Diseases Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Seyedeh Neda', 'Initials': 'SN', 'LastName': 'Mousavi', 'Affiliation': 'Zanjan Metaboilc Diseases Research Center, Zanjan University of Medical Sciences, Zanjan, Iran; Department of Nutrition, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran. Electronic address: neda.mousavi@zums.ac.ir.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Chiti', 'Affiliation': 'Zanjan Metaboilc Diseases Research Center, Zanjan University of Medical Sciences, Zanjan, Iran. Electronic address: dr.chiti@zums.ac.ir.'}, {'ForeName': 'Davoud', 'Initials': 'D', 'LastName': 'Afshar', 'Affiliation': 'Department of Microbiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2022.04.007']
1197,35609510,Effects of the mu-opioid receptor agonist morphine on facial mimicry and emotion recognition.,"Facial mimicry and emotion recognition are two socio-cognitive abilities involved in adaptive socio-emotional behavior, promoting affiliation and the establishment of social bonds. The mu-opioid receptor (MOR) system plays a key role in affiliation and social bonding. However, it remains unclear whether MORs are involved in the categorization and spontaneous mimicry of emotional facial expressions. Using a randomized, placebo-controlled, double-blind, between-subjects design, we investigated in 82 healthy female volunteers the effects of the specific MOR agonist morphine on the recognition accuracy of emotional faces (happiness, anger, fear), and on their facial mimicry (measured with electromyography). Frequentist statistics did not reveal any significant effects of drug administration on facial mimicry or emotion recognition abilities. However, post hoc Bayesian analyses provided support for an effect of morphine on facial mimicry of fearful facial expressions. Specifically, compared to placebo, morphine reduced mimicry of fear, as shown by lower activity of the frontalis muscle. Bayesian analyses also provided support for the absence of a drug effect on mimicry of happy and angry facial expressions, which were assessed with the zygomaticus major and corrugator supercilii muscles, as well as on emotion recognition accuracy. These findings suggest that MOR activity is involved in automatic facial responses to fearful stimuli, but not in their identification. Overall, the current results, together with the previously reported small effects of opioid compounds, suggest a relatively marginal role of the MOR system in emotion simulation and perception.",2022,"Specifically, compared to placebo, morphine reduced mimicry of fear, as shown by lower activity of the frontalis muscle.",['82 healthy female volunteers'],"['mu-opioid receptor agonist morphine', 'placebo, morphine', 'specific MOR agonist morphine', 'morphine', 'placebo']","['recognition accuracy of emotional faces (happiness, anger, fear), and on their facial mimicry (measured with electromyography', 'mimicry of happy and angry facial expressions', 'facial mimicry or emotion recognition abilities', 'facial mimicry and emotion recognition', 'facial mimicry of fearful facial expressions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0066908', 'cui_str': 'mu Opioid Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0233577', 'cui_str': 'Mimicry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",82.0,0.144866,"Specifically, compared to placebo, morphine reduced mimicry of fear, as shown by lower activity of the frontalis muscle.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Massaccesi', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Austria. Electronic address: claudia.massaccesi@univie.ac.at.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Korb', 'Affiliation': 'Department of Psychology, University of Essex, Colchester, United Kingdom; Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Austria.'}, {'ForeName': 'Matthaeus', 'Initials': 'M', 'LastName': 'Willeit', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital of the University of Zurich, Zurich, Switzerland; Neuroscience Center Zurich, University of Zurich and Swiss Federal Institute of Technology, Zurich, Switzerland.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Silani', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Austria.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2022.105801']
1198,35609468,The effectiveness of PROMISE minimal smoking cessation intervention strategy to improve the adherence to smoking cessation counselling during pregnancy: A stepped-wedge cluster randomized controlled trial.,,2022,,[],[],[],[],[],[],,0.0485905,,"[{'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Bommelé', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands. Electronic address: jbommele@trimbos.nl.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Springvloet', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}, {'ForeName': 'Naïma', 'Initials': 'N', 'LastName': 'Abouri', 'Affiliation': 'Pharos, Utrecht, the Netherlands.'}, {'ForeName': 'Karianne', 'Initials': 'K', 'LastName': 'Djoyoadhiningrat-Hol', 'Affiliation': 'Lung Foundation Netherlands, Amersfoort, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'van Laar', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.'}]",Midwifery,['10.1016/j.midw.2022.103364']
1199,35609409,Molecular profiling of non-small-cell lung cancer patients with or without brain metastases included in the randomized SAFIR02-LUNG trial and association with intracranial outcome.,"INTRODUCTION


Lung cancer remains the most frequent cause of brain metastases (BMs) and is responsible for high morbidity and mortality. Intracranial response to systemic treatments is inconsistent due to several mechanisms: genomic heterogeneity, blood-tumor barrier, and the brain-specific microenvironment. We conducted a study using data from the SAFIR02-LUNG trial. The primary objective was to compare the molecular profiles of non-small-cell lung cancer (NSCLC) with or without BMs. The secondary objective was to explore central nervous system (CNS) outcomes with various maintenance treatment regimens.
METHODS


In total, 365 patients harboring interpretable molecular data were included in this analysis. Clinical and biological data were collected. Genomic analyses were based on array-comparative genomic hybridization and next-generation sequencing (NGS) following the trial recommendations.
RESULTS


Baseline genomic analyses of copy number variations identified a 24-gene signature specific to lung cancer BM occurrence, all previously known to take part in oncogenesis. NGS analysis identified a higher proportion of KRAS mutations in the BM-positive group (44.3% versus 32.3%), especially G12C mutations (63% versus 47%). Protein interaction analyses highlighted several functional interactions centered on EGFR. Furthermore, the risk of CNS progression was decreased with standard pemetrexed maintenance therapy. The highest rate of CNS progression was observed with durvalumab, probably because of the specific intracranial immune microenvironment.
CONCLUSION


This work identified a 24-gene signature specific to lung cancer with BM. Further studies are needed to precisely determine the functional implications of these genes to identify new therapeutic targets for the treatment of lung cancer with BM.",2022,"NGS analysis identified a higher proportion of KRAS mutations in the BM-positive group (44.3% versus 32.3%), especially G12C mutations (63% versus 47%).","['non-small-cell lung cancer patients with or without brain metastases', '365 patients harboring interpretable molecular data', 'lung cancer with BM']",[],"['central nervous system (CNS) outcomes', 'KRAS mutations', 'highest rate of CNS progression', 'risk of CNS progression', 'molecular profiles of non-small-cell lung cancer (NSCLC']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]",[],"[{'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]",365.0,0.406123,"NGS analysis identified a higher proportion of KRAS mutations in the BM-positive group (44.3% versus 32.3%), especially G12C mutations (63% versus 47%).","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mogenet', 'Affiliation': 'Aix Marseille Univ, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': ""Université Paris-Saclay and Medical Oncology, Gustave Roussy, Cancer Campus, 94805 Villejuif, France; Aix Marseille Univ, Centre de Recherche en Cancérologie de Marseille (CRCM), INSERM UMR1068, CNRS UMR725, Laboratoire d'Oncologie Prédictive, Marseille, France.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Université Paris-Saclay and Medical Oncology, Gustave Roussy, Cancer Campus, 94805 Villejuif, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Michiels', 'Affiliation': 'Office of Biostatistics and Epidemiology, Institut Gustave Roussy, Université Paris-Saclay, 94805 Villejuif, France; Oncostat U1018, INSERM, Université Paris-Saclay, labeled Ligue Contre le Cancer, 94805 Villejuif, France.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'Office of Biostatistics and Epidemiology, Institut Gustave Roussy, Université Paris-Saclay, 94805 Villejuif, France; Oncostat U1018, INSERM, Université Paris-Saclay, labeled Ligue Contre le Cancer, 94805 Villejuif, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Tran-Dien', 'Affiliation': 'Institut Gustave Roussy, INSERM Unité 981, 94805 Villejuif, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girard', 'Affiliation': 'Institut du Thorax Curie Montsouris, Institut Curie and Paris-Saclay University, Paris. France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Thoracic Oncology Department, Toulouse University Hospital, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Centre Hospitalier Sainte Musse, Pneumology Department, Toulon, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Locatelli-Sanchez', 'Affiliation': 'Department of Pneumology and Thoracic Oncology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Drug Development and Innovation, Institut Curie, PSL Research University, 75005 Paris & 92210 Saint-Cloud, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gestraud', 'Affiliation': 'Bioinformatics and Computational Systems Biology of Cancer, PSL Research University, Mines Paris Tech, INSERM U900, 75005 Paris, France.'}, {'ForeName': 'Abderaouf', 'Initials': 'A', 'LastName': 'Hamza', 'Affiliation': 'Department of Genetics, Institut Curie, University of Paris, 75005 Paris, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jacquet', 'Affiliation': 'UNICANCER, 75654 Paris, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jimenez', 'Affiliation': 'UNICANCER, 75654 Paris, France.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Yara', 'Affiliation': 'UNICANCER, 75654 Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Aix Marseille Univ, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bertucci', 'Affiliation': ""Aix Marseille Univ, Centre de Recherche en Cancérologie de Marseille (CRCM), INSERM UMR1068, CNRS UMR725, Laboratoire d'Oncologie Prédictive, Marseille, France; Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Université Paris-Saclay and Medical Oncology, Gustave Roussy, Cancer Campus, 94805 Villejuif, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Soria', 'Affiliation': 'Université Paris-Saclay and Medical Oncology, Gustave Roussy, Cancer Campus, 94805 Villejuif, France.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bieche', 'Affiliation': 'Department of Genetics, Institut Curie, University of Paris, 75005 Paris, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Tomasini', 'Affiliation': 'Aix Marseille Univ, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France. Electronic address: pascale.tomasini@ap-hm.fr.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2022.05.004']
1200,35609351,Predictive performance of peritoneal fluid in the pouch of Douglas measured five days after oocyte pick-up in predicting severe late-onset OHSS: A secondary analysis of a randomized trial.,"OBJECTIVES


To investigate if the amount of peritoneal fluid (PF) in the Pouch of Douglas at oocyte pick-up (OPU) or OPU + 5 days predict severe late-onset ovarian hyperstimulation syndrome (OHSS) in women undergoing ovarian stimulation for assisted reproductive technology (ART).
STUDY DESIGN


A secondary analysis of a dual-centre RCT on 1050 women referred for their first ART treatment in two public fertility clinics in Denmark and randomized 1:1 to GnRH-antagonist or GnRH-agonist protocol. All women from the two arms who were examined on day of OPU and OPU + 5 days were included in this study (n = 940). The ability of PF in the pouch of Douglas to predict severe late-onset OHSS was assessed by multivariate logistic regression analyses and receiver operator characteristics (ROC) curve analyses and compared with other known predictors of OHSS. The final models were cross-validated by the leave-one-out method to assess the models' generalizability.
RESULTS


A total of 28 (3%) women developed severe late-onset OHSS. PF in the pouch of Douglas measured on OPU + 5 days predicted severe late-onset OHSS. The optimal cut-off value was 17.5 mm at OPU + 5 days with a 61% sensitivity and 71% specificity (Area under the curve = 0.70 95% CI 0.61-0.80). PF on the day of OPU was not predictive of late on-set OHSS as the adjusted multivariate logistic regression analyses showed insignificant results.
CONCLUSION


Although PF in the pouch of Douglas could predict late-onset severe OHSS, the low sensitivity underlines that it is not useful as a sole marker to decide whether to perform blastocyst transfer or to use a freeze-all strategy.",2022,"PF on the day of OPU was not predictive of late on-set OHSS as the adjusted multivariate logistic regression analyses showed insignificant results.
","['All women from the two arms who were examined on day of OPU and OPU\xa0+\xa05\xa0days were included in this study (n\xa0=\xa0940', '1050 women referred for their first ART treatment in two public fertility clinics in Denmark', 'women undergoing ovarian stimulation for assisted reproductive technology (ART']","['GnRH-antagonist or GnRH-agonist protocol', 'peritoneal fluid (PF']",['severe late-onset OHSS'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0872104', 'cui_str': 'Assisted reproductive technology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4760630', 'cui_str': 'Infertility Clinics'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0003964', 'cui_str': 'Ascitic fluid'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}]",1050.0,0.196084,"PF on the day of OPU was not predictive of late on-set OHSS as the adjusted multivariate logistic regression analyses showed insignificant results.
","[{'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Grynnerup', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, DK-2650 Hvidovre, Denmark. Electronic address: anna.garcia-alix.haugen.grynnerup.01@regionh.dk.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, DK-2650 Hvidovre, Denmark; Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toftager', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Bogstad', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, DK-2650 Hvidovre, Denmark; Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Prætorius', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, DK-2650 Hvidovre, Denmark; Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2022.05.004']
1201,35613415,"Aerobic exercise, mindfulness meditation, and stress-reduction in high-stress, college-based young adults: A pilot study.","This pilot study assessed the feasibility and combined effect of aerobic exercise (AE) and mindfulness meditation (MM), compared with MM alone and a control (CON) condition, on stress, anxiety, and depression in high-stress college-based young adults. Thirty-two participants (84.4% F, 20.5 ± 2.7 years, 23.9 ± 5.0 kg/m 2 ) were randomized to a four-week, AE + MM ( n  = 16), MM ( n  = 10), or control intervention ( n  = 6). ANOVA revealed non-significant, but noteworthy group x time interactions (perceived stress:  p  = 0.09; anxiety/depression:  p  = 0.07). Both AE + MM and MM seem to be feasible strategies to reduce levels of stress, anxiety and depression in college-based young adults.",2022,"ANOVA revealed non-significant, but noteworthy group x time interactions (perceived stress:  p  = 0.09; anxiety/depression:  p  = 0.07).","['high-stress college-based young adults', 'Thirty-two participants (84.4% F, 20.5\u2009±\u20092.7\u2009years, 23.9\u2009±\u20095.0\u2009kg/m 2 ', 'college-based young adults', 'high-stress, college-based young adults']","['control intervention', 'aerobic exercise (AE) and mindfulness meditation (MM', 'Aerobic exercise, mindfulness meditation, and stress-reduction', 'MM alone and a control (CON) condition', 'AE\u2009+\u2009MM']","['levels of stress, anxiety and depression', 'stress, anxiety, and depression']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",32.0,0.0233403,"ANOVA revealed non-significant, but noteworthy group x time interactions (perceived stress:  p  = 0.09; anxiety/depression:  p  = 0.07).","[{'ForeName': 'Gabriel H', 'Initials': 'GH', 'LastName': 'Zieff', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Barnett', 'Initials': 'B', 'LastName': 'Frank', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gaylord', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Memorial Hospital, University of North Carolina at Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Battle', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2022.2076103']
1202,35613385,Effect of Maternal Diet on Any Necrotizing Enterocolitis in Neonates: A Randomized Double-Blind Study.,"Background:  The etiology of necrotizing enterocolitis (NEC) is controversially discussed. One of the most recently proposed causes of NEC is an allergy to cow's milk protein. This study was designed to evaluate the effect of a maternal diet without bovine protein on the incidence of any NEC in very low birth weight (VLBW) infants.  Materials and Methods:  A pilot randomized controlled clinical trial was performed at Akbarabadi Hospital, Tehran, Iran, from December 2019 to July 2020, in women with VLBW infants. One hundred twenty mothers with VLBW neonates were randomly assigned to the intervention or the control group (60 in each). In the intervention group, mothers were given a dairy-free diet during the first 14 days after the newborn's onset of feeding. No special diet was given to the control group. The primary outcome of the study was the rate of any NEC in neonates, which was compared between groups. Any NEC was defined as Bell stage I or greater.  Results:  The minimum and maximum gestational ages were 26 and 33 weeks, respectively. The minimum birth weight of neonates was 700 g. The two groups did not differ significantly in terms of demographic and preinterventional clinical characteristics. Any NEC was reported in 0% and 10% (5/52) of neonates in the intervention and control groups, respectively; the difference was statistically significant ( p  = 0.028). The NEC symptoms began ∼34 days after birth. Four cases of NEC were classified as Bell stage I, and one was classified as Bell stage II. No statistical association was registered between sex, gestational age, birth weight, and the onset of feeding with the incidence of any NEC.  Conclusion:  The use of a cow's milk protein-free diet in mothers and exclusive breastfeeding in preterm VLBW infants may reduce the incidence of NEC. We recommend further studies with larger sample sizes in a multicenter setting. The study was registered at the Iranian Registry of Clinical Trials (IRCT20200415047086N1).",2022,"Any NEC was reported in 0% and 10% (5/52) of neonates in the intervention and control groups, respectively; the difference was statistically significant ( p  = 0.028).","['Akbarabadi Hospital, Tehran, Iran, from December 2019 to July 2020, in women with VLBW infants', 'Neonates', 'very low birth weight (VLBW) infants', 'mothers and exclusive breastfeeding in preterm VLBW infants', 'of neonates was 700', 'One hundred twenty mothers with VLBW neonates']","['dairy-free diet', 'Maternal Diet', ""cow's milk protein-free diet"", 'maternal diet without bovine protein']","['rate of any NEC', 'demographic and preinterventional clinical characteristics', 'Necrotizing Enterocolitis', 'minimum birth weight']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0860073', 'cui_str': 'Dairy free diet'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452381', 'cui_str': ""Cow's milk protein-free diet""}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",120.0,0.0787205,"Any NEC was reported in 0% and 10% (5/52) of neonates in the intervention and control groups, respectively; the difference was statistically significant ( p  = 0.028).","[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Khalesi', 'Affiliation': ""Department of Neonatology, Aliasghar Children's Hospital, School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.""}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Mazloomi Nobandegani', 'Affiliation': ""Department of Neonatology, Aliasghar Children's Hospital, School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.""}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Khosravi', 'Affiliation': ""Department of Neonatology, Aliasghar Children's Hospital, School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saboute', 'Affiliation': 'Department of Neonatology, Akbar Abadi Hospital, Iran University of Medical Sciences, (IUMS), Tehran, Iran.'}, {'ForeName': 'Seyyede Faride', 'Initials': 'SF', 'LastName': 'Farahi', 'Affiliation': ""Department of Neonatology, Aliasghar Children's Hospital, School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.""}, {'ForeName': 'Zinat', 'Initials': 'Z', 'LastName': 'Shakeri', 'Affiliation': ""Department of Neonatology, Aliasghar Children's Hospital, School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.""}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Midwifery Office, Ministry of Health and Medical Education, Tehran, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2021.0371']
1203,35614509,The impact of medication reviews by general practitioners on psychotropic drug use and behavioral and psychological symptoms in home-dwelling people with dementia: results from the multicomponent cluster randomized controlled LIVE@Home.Path trial.,"BACKGROUND


There is limited knowledge regarding the process of deprescribing psychotropic drugs to people with dementia (PwD) conducted by general practitioners (GP). We investigated the impact of a multicomponent intervention, emphasizing medication reviews, on psychotropic drugs and behavioral and psychological symptoms (BPSD) in home-dwelling PwD and quantified change in patient-GP communication evaluated by their informal caregivers.
METHODS


LIVE@Home.Path is a stepped-wedge closed-cohort cluster randomized controlled trial for people with mild to moderate dementia aged ≥65 and their informal caregivers (dyads) in Norway. Complementary to health care as usual (control condition), municipal coordinators implemented the multicomponent LIVE intervention: Learning, Innovation, Volunteer support, and Empowerment (including medication review by the PwD's regular GPs). Block-randomization was used to allocate dyads in three groups receiving the intervention sequentially in periods of 6 months duration. Prepandemic data from the first period is reported, resulting in a 1:2 intervention-to-control ratio. Primary outcome was change in psychotropic drug use. Secondary outcomes were changes in BPSD by Neuropsychiatric Inventory and Cornell Scale of Depression in Dementia and patient-GP communication by an adaption of the Clinical Global Impression of Change.
RESULTS


Four hundred thirty-eight dyads were screened, 280 included, and 237 participated at 6 months (intervention group n=67; control condition n=170). At baseline, 63% used psychotropic medication regularly: antidementia drugs (47%), antidepressants (13%), hypnotics/sedatives (13%), antipsychotics (5%), and anxiolytics (2%). At 6 months, medication reviews were more frequently conducted in the intervention group compared to control (66% vs 42%, P=0.001). We found no differences regarding a change in drug use and BPSD. Patient-GP communication enhanced in the intervention group (mean score 0.95 [standard deviation 1.68] vs 0.41 [1.34], P=0.022). In the intervention group, control group, and overall sample, the informal caregivers of those who had their medications reviewed reported improved patient-GP communication compared to those who did not.
CONCLUSIONS


Change in psychotropic drug use and BPSD did not differ, even though patient-GP communication improved with medication reviews. Restricted psychotropic drug use among PwD likely reflects more judicious prescribing practices in recent years. Nevertheless, medication reviews could be cultivated to optimize pharmacologic treatment for this complex population.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT04043364 ; registered 15/03/2019.",2022,"Patient-GP communication enhanced in the intervention group (mean score 0.95 [standard deviation 1.68] vs 0.41 [1.34], P=0.022).","['Four hundred thirty-eight dyads were screened, 280 included, and 237 participated at 6 months (intervention group n=67; control condition n=170', 'people with mild to moderate dementia aged ≥65 and their informal caregivers (dyads) in Norway', 'home-dwelling people with dementia', 'people with dementia (PwD) conducted by general practitioners (GP']",[],"['hypnotics/sedatives', 'change in psychotropic drug use', 'Patient-GP communication', 'patient-GP communication', 'drug use and BPSD', 'changes in BPSD by Neuropsychiatric Inventory and Cornell Scale of Depression in Dementia and patient-GP communication by an adaption of the Clinical Global Impression of Change']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]",[],"[{'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1868717', 'cui_str': 'Behavioural and psychiatric symptoms of dementia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",438.0,0.0838732,"Patient-GP communication enhanced in the intervention group (mean score 0.95 [standard deviation 1.68] vs 0.41 [1.34], P=0.022).","[{'ForeName': 'Marie H', 'Initials': 'MH', 'LastName': 'Gedde', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway. marie.gedde@uib.no.'}, {'ForeName': 'Bettina S', 'Initials': 'BS', 'LastName': 'Husebo', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Mannseth', 'Affiliation': 'Section for Epidemiology and Medical Statistic, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mala', 'Initials': 'M', 'LastName': 'Naik', 'Affiliation': 'Haraldsplass Deaconess Hospital, Bergen, Norway.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Selbaek', 'Affiliation': 'Norwegian National Centre for Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Maarja', 'Initials': 'M', 'LastName': 'Vislapuu', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Line Iden', 'Initials': 'LI', 'LastName': 'Berge', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}]",BMC medicine,['10.1186/s12916-022-02382-5']
1204,35614875,Leicester Cough Questionnaire validation and clinically important thresholds for change in refractory or unexplained chronic cough.,"INTRODUCTION


The Leicester Cough Questionnaire (LCQ), a cough-specific quality-of-life measure, evaluates the impact of cough across physical, psychological, and social domains in patients with chronic cough (CC). This study assessed the psychometric properties of the LCQ.
METHODS


Data from a phase IIb, randomized controlled trial of the P2X3-receptor antagonist gefapixant were analyzed (NCT02612610). Subjective [Cough Severity Diary, cough severity visual analogue scale, and patient global impression of change (PGIC)] and objective (awake and 24-h cough frequency) data were used to validate the LCQ for use in patients with refractory or unexplained CC (RCC and UCC, respectively). Psychometric analyses included confirmatory factor analyses, internal consistency and test-retest reliability, validity, responsiveness, and estimated within-patient thresholds for clinically meaningful change.
RESULTS


Model-fit values for the proposed three-factor LCQ domains and most individual items were acceptable. Analyses suggest that a mean improvement ranging from 1.3 to 2.3 points for the LCQ total and ⩾0.8, ⩾0.9, and ⩾0.8 points for physical, psychological, and social domain scores, respectively, had the best sensitivity and/or specificity for predicting patient ratings of improvement on the PGIC.
CONCLUSIONS


The LCQ is a valid and reliable measure to evaluate cough-specific quality of life and is a fit-for-purpose measure for use in patients with RCC or UCC. Although a single threshold for defining clinically meaningful change depends on the context of use, the results can help guide both treatment decisions and drug development. Therefore, clinicians may consider a ⩾1.3-point increase in the LCQ total score as clinically meaningful.",2022,The LCQ is a valid and reliable measure to evaluate cough-specific quality of life and is a fit-for-purpose measure for use in patients with RCC or UCC.,"['patients with chronic cough (CC', 'patients with refractory or unexplained CC (RCC and UCC, respectively', 'patients with RCC or UCC']","['LCQ', 'P2X3-receptor antagonist gefapixant']","['Subjective [Cough Severity Diary, cough severity visual analogue scale, and patient global impression of change (PGIC)] and objective (awake and 24-h cough frequency) data', 'physical, psychological, and social domain scores', 'Leicester Cough Questionnaire validation', 'Leicester Cough Questionnaire (LCQ), a cough-specific quality-of-life measure, evaluates the impact of cough across physical, psychological, and social domains', 'confirmatory factor analyses, internal consistency and test-retest reliability, validity, responsiveness, and estimated within-patient thresholds for clinically meaningful change', 'LCQ total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0382265', 'cui_str': 'P2X3 Purinoceptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0672651,The LCQ is a valid and reliable measure to evaluate cough-specific quality of life and is a fit-for-purpose measure for use in patients with RCC or UCC.,"[{'ForeName': 'Allison Martin', 'Initials': 'AM', 'LastName': 'Nguyen', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Schelfhout', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muccino', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Bacci', 'Affiliation': 'Evidera, Seattle, WA, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'La Rosa', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Vernon', 'Affiliation': 'Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, Denmark Hill, London SE5 9RS, UK.""}]",Therapeutic advances in respiratory disease,['10.1177/17534666221099737']
1205,35614848,Carbohydrate quantity is more closely associated with glycaemic control than weight in pregnant women with type 1 diabetes: Insights from the Diabetes and Pre-eclampsia Intervention Trial (DAPIT).,"BACKGROUND


The present study aimed to explore the relationships between carbohydrate intake, body mass index (BMI) and glycaemic control (HbA1c) in pregnant women with type 1 diabetes mellitus (T1DM) METHODS: Secondary analysis of data was undertaken to assess dietary intake in a cohort of women who participated in a randomised controlled trial (RCT) of antioxidant supplementation to prevent preeclampsia (DAPIT 10  ). Study-specific peripheral venous blood samples were obtained for HbA1c at 26 and 34 weeks. Diet was collected using a validated semiquantitative food frequency questionnaire at 26-28 weeks of gestation which assessed dietary intake over 2 weeks. Mean daily average nutrient intakes were analysed using Q Builder nutritional software and SPSS, version 25.
RESULTS


Dietary data were available for 547 pregnant women (72% of cohort) aged 29 years (95% confidence interval [CI] = 28.9-29.9) with average diabetes duration 11.8 years (95% confidence interval = 11.1-12.6). Average body mass index (BMI) (<16 weeks of gestation) was 26.7 kg/m 2  (95% CI = 26.3 -27, range 18.8-45.6 kg/m 2  ); 43% (n = 234) were overweight (BMI = 25.0-29.9 kg/m 2  ) and 20% (n = 112) were obese (BMI ≥ 30 kg/m 2  ). Differences in HbA1c and carbohydrate quantity and quality were found when adjusted for age and insulin dose. No differences between BMI group were observed for total carbohydrate and glycaemic control; however, differences were noted in fibre and glycaemic index.
CONCLUSIONS


Average quantity of dietary carbohydrate influenced HbA1c when adjusted for insulin dose however, BMI had less impact. More research is required on the relationship between carbohydrate consumption and glycaemic control in pregnancy.",2022,"No differences between BMI group were observed in total carbohydrate and glycaemic control, however, differences were noted in fibre and glycaemic index.
","['pregnant women with type 1 diabetes mellitus (T1DM) METHODS', '547 pregnant women (72% of cohort) aged 29 years (95% CI 28.9-29.9) with average diabetes duration 11.8 years (95% CI 11.1-12.6', 'pregnant women with type 1 diabetes', 'range 18.8-45.6 kg/m 2  ); 43% (n=234) were overweight (BMI 25.0 - 29.9kg/m 2  ) and 20% (n= 112) were obese (BMI>30kg/m 2  ']","['carbohydrate intake, body mass index and glycaemic control (HbA1c', 'antioxidant supplementation']","['Average BMI', 'HbA1c and carbohydrate quantity and quality', 'total carbohydrate and glycaemic control', 'fibre and glycaemic index', 'Carbohydrate quantity', 'Mean daily average nutrient intakes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",547.0,0.134326,"No differences between BMI group were observed in total carbohydrate and glycaemic control, however, differences were noted in fibre and glycaemic index.
","[{'ForeName': 'Alyson J', 'Initials': 'AJ', 'LastName': 'Hill', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), School of Biomedical Sciences, University of Ulster, Coleraine, UK.'}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Patterson', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Young', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Holmes', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'McCance', 'Affiliation': 'Regional Centre for Endocrinology and Diabetes, Royal Victoria Hospital, Belfast, UK.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.13042']
1206,35614845,Cardiometabolic effects of early  v . delayed time-restricted eating plus energetic restriction in adults with overweight and obesity: an exploratory randomised clinical trial.,"This exploratory study investigated the effects of early  v . delayed time-restricted eating (TRE) plus caloric restriction (CR) on body weight, body composition and cardiometabolic parameters in adults with overweight and obesity. Adults (20-40 years) were randomised to one of three groups for 8 weeks: early time-restricted eating (eTRE; 08.00-16.00) plus CR, delayed time-restricted eating (dTRE; 12.00-20.00) plus CR or only CR (CR; 08.00-20.00). All groups were prescribed a 25 % energy deficit relative to daily energy requirements. Thirteen participants completed the study in the eTRE and CR groups and eleven in the dTRE group ( n  37). After the interventions, there was no significant difference between the three groups for any of the outcomes. Compared with baseline, significant decreases were observed in the body weight (eTRE group: -4·2 kg; 95 % CI, -5·6, -2·7; dTRE group: -4·8 kg; 95 % CI, -5·9, -3·7; CR: -4·0 kg; 95 % CI, -5·9, -2·1), fat mass (eTRE group: -2·9 kg; 95 % CI, -3·9, -1·9; dTRE group: -3·6 kg; 95 % CI, -4·6, -2·5; CR: -3·1 kg; 95 % CI, -4·3, -1·8) and fasting glucose levels (eTRE group: -4 mg/dl; 95 % CI, -8, -1; dTRE group: -2 mg/dl; 95 % CI, -8, 3; CR: -3 mg/dl; 95 % CI, -8, 2). In a free-living setting, TRE with a energetic deficit, regardless of the time of day, promotes similar benefits in weight loss, body composition and cardiometabolic parameters. However, given the exploratory nature of our study, further investigation is needed to confirm these findings.",2022,"After the interventions, there was no significant difference between the three groups for any of the outcomes.","['Adults (20 to 40 years', 'Thirteen participants completed the study in the eTRE and CR groups, and eleven in the dTRE group (n=37', 'adults with overweight and obesity', 'Adults with Overweight and Obesity']","['Early vs. Delayed Time-Restricted Eating Plus Caloric Restriction', 'early vs. delayed time-restricted eating (TRE) plus caloric restriction (CR']","['body weight, body composition, and cardiometabolic parameters', 'body weight', 'fasting glucose levels', 'weight loss, body composition and cardiometabolic parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",13.0,0.0638134,"After the interventions, there was no significant difference between the three groups for any of the outcomes.","[{'ForeName': 'Jéssica do Nascimento', 'Initials': 'JDN', 'LastName': 'Queiroz', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Rodrigo Cauduro Oliveira', 'Initials': 'RCO', 'LastName': 'Macedo', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Gabriela Cristina', 'Initials': 'GC', 'LastName': 'Dos Santos', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Samuel Vargas', 'Initials': 'SV', 'LastName': 'Munhoz', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Carlos Leonardo Figueiredo', 'Initials': 'CLF', 'LastName': 'Machado', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Rodrigo Leal', 'Initials': 'RL', 'LastName': 'de Menezes', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Elisa Nascimento', 'Initials': 'EN', 'LastName': 'Menzem', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Cesar Eduardo Jacintho', 'Initials': 'CEJ', 'LastName': 'Moritz', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Ronei Silveira', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Tinsley', 'Affiliation': 'Department of Kinesiology & Sport Management at Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Alvaro Reischak', 'Initials': 'AR', 'LastName': 'de Oliveira', 'Affiliation': 'Exercise Research Laboratory, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114522001581']
1207,35627382,The Role of Tobacco Smoking in the Efficacy of Brief Alcohol Intervention: Results from a Randomized Controlled Trial.,"This study investigated whether tobacco smoking affected outcomes of brief alcohol interventions (BAIs) in at-risk alcohol-drinking general hospital patients. Between 2011 and 2012 among patients aged 18-64 years, 961 patients were allocated to in-person counseling (PE), computer-based BAI containing computer-generated individual feedback letters (CO), and assessment only. PE and CO included contacts at baseline, 1, and 3 months. After 6, 12, 18, and 24 months, self-reported reduction of alcohol use per day was assessed as an outcome. By using latent growth curve models, self-reported smoking status, and number of cigarettes per day were tested as moderators. In PE and CO, alcohol use was reduced independently of smoking status (IRRs ≤ 0.61,  p s &lt; 0.005). At month 24, neither smoking status nor number of cigarettes per day moderated the efficacy of PE (IRR = 0.69,  p s &gt; 0.05) and CO (IRR = 0.85,  p s &gt; 0.05). Up to month 12, among persons smoking ≤ 19 cigarettes per day, the efficacy of CO increased with an increasing number of cigarettes ( p s &lt; 0.05). After 24 months, the efficacy of PE and CO that have been shown to reduce drinking did not differ by smoking status or number of cigarettes per day. Findings indicate that efficacy may differ by the number of cigarettes in the short term.",2022,"After 24 months, the efficacy of PE and CO that have been shown to reduce drinking did not differ by smoking status or number of cigarettes per day.","['Between 2011 and 2012 among patients aged 18-64 years, 961 patients', 'at-risk alcohol-drinking general hospital patients']","['tobacco smoking', 'person counseling (PE), computer-based BAI containing computer-generated individual feedback letters (CO), and assessment only', 'Tobacco Smoking', 'brief alcohol interventions (BAIs', 'Alcohol Intervention']","['efficacy of CO', 'number of cigarettes', 'smoking status nor number of cigarettes per day moderated the efficacy of PE', 'smoking status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0556297', 'cui_str': 'Current drinker'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",,0.0592926,"After 24 months, the efficacy of PE and CO that have been shown to reduce drinking did not differ by smoking status or number of cigarettes per day.","[{'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Krolo', 'Affiliation': 'Institute for Medical Psychology, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'Department of Methods in Community Medicine, Institute of Community Medicine, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Tiede', 'Affiliation': 'Institute for Medical Psychology, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany.'}, {'ForeName': 'Gallus', 'Initials': 'G', 'LastName': 'Bischof', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Krause', 'Affiliation': 'Institute for Medical Psychology, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'German Centre for Cardiovascular Research, Partner Site Greifswald, Fleischmannstr. 42-44, D-17475 Greifswald, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'John', 'Affiliation': 'German Centre for Cardiovascular Research, Partner Site Greifswald, Fleischmannstr. 42-44, D-17475 Greifswald, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Gaertner', 'Affiliation': 'Department of Epidemiology and Health Monitoring, Robert Koch Institute Berlin, General-Pape-Str. 62-66, D-12101 Berlin, Germany.'}, {'ForeName': 'Jennis', 'Initials': 'J', 'LastName': 'Freyer-Adam', 'Affiliation': 'Institute for Medical Psychology, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19105847']
1208,35627352,Effectiveness of Standardized Protocol for Oxygen Therapy on Improving Nurses' Performance and Patients' Health Outcome.,"AIMS


assess nurses' knowledge and performance-related safe administration of oxygen (O2) therapy; apply an intervention program for nurses about standardized protocol for oxygen; and evaluate the effectiveness of standardized protocol for oxygen in improving nurses' performance and patients' health outcomes.
DESIGN


a quasi-experimental study was used.
SETTING


the current study was conducted at three hospitals in Sakaka City with totally different medical aid units (ICUs), CCUs, emergency care departments (ED), medical and surgical wards, pediatric care units (PICUs), neonatal intensive care units (NICUs), pediatric emergency care departments (PED) and pediatric inpatient\outpatient departments.
SUBJECTS


a convenience sample of 105 nurses and 105 patients was divided into 55 patients in the control group who received routine care and 50 patients in the study group who received intervention.
FINDINGS


34.3% of studied nurses had poor knowledge pre-intervention compared with 17% post-intervention. Moreover, 33.3% of them had satisfactory knowledge pre-intervention versus 21% post-intervention. Only 5.7% of them had excellent knowledge pre-intervention, compared with 34.4% post-intervention. Concerning the complications of oxygen therapy, only 10.5% did not have complications in the control group versus 62.9% in the study group, 33.3% of the control group had cyanotic lips and fingernails pre-intervention, versus 7.6% in the study group; 10.5% had oxygen toxicity in the control group, versus 7.6% in the study group, with a highly statistically significant difference at p 0.001 for all.
CONCLUSION


the current results of this study concluded that there was improvement in nurses' knowledge and practice related to oxygen therapy post-intervention. Moreover, when the standard protocol for safe oxygen therapy was used in a positive way, it led to better health for patients and fewer problems with oxygen therapy.",2022,"Only 5.7% of them had excellent knowledge pre-intervention, compared with 34.4% post-intervention.","['nurses about standardized protocol for oxygen', 'the current study was conducted at three hospitals in Sakaka City with totally different medical aid units (ICUs), CCUs, emergency care departments (ED), medical and surgical wards, pediatric care units (PICUs), neonatal intensive care units (NICUs), pediatric emergency care departments (PED) and pediatric inpatient\\outpatient departments', 'a convenience sample of 105 nurses and 105 patients was divided into 55 patients in the control group who received']","['oxygen (O2) therapy', 'routine care', 'Standardized Protocol for Oxygen Therapy', 'intervention']","['cyanotic lips', 'complications', 'oxygen toxicity']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1948041', 'cui_str': 'Surgical and medical procedures'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0240194', 'cui_str': 'Blue lips'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0238327', 'cui_str': 'Oxygen toxicity'}]",105.0,0.016505,"Only 5.7% of them had excellent knowledge pre-intervention, compared with 34.4% post-intervention.","[{'ForeName': 'Samar Salah Eldin Mohamed', 'Initials': 'SSEM', 'LastName': 'Diab', 'Affiliation': 'Department of Nursing, College of Applied Medical Science, Jouf University, Sakaka 2014, Saudi Arabia.'}, {'ForeName': 'Shaimaa Ahmed Awad', 'Initials': 'SAA', 'LastName': 'Ali', 'Affiliation': 'Department of Nursing, College of Applied Medical Science, Jouf University, Sakaka 2014, Saudi Arabia.'}, {'ForeName': 'Shaymaa Najm', 'Initials': 'SN', 'LastName': 'Abed', 'Affiliation': 'Department of Nursing, College of Applied Medical Science, Jouf University, Sakaka 2014, Saudi Arabia.'}, {'ForeName': 'Gehan Abd Elfattah Atia', 'Initials': 'GAEA', 'LastName': 'Elasrag', 'Affiliation': 'Department of Nursing, College of Applied Medical Science, Jouf University, Sakaka 2014, Saudi Arabia.'}, {'ForeName': 'Osama Mohamed Elsayed', 'Initials': 'OME', 'LastName': 'Ramadan', 'Affiliation': 'Department of Nursing, College of Applied Medical Science, Jouf University, Sakaka 2014, Saudi Arabia.'}]",International journal of environmental research and public health,['10.3390/ijerph19105817']
1209,35627351,Effects of Core Training in Physical Fitness of Youth Karate Athletes: A Controlled Study Design.,"This study aimed to analyse the impact of an 8-week core strength training (CST) programme in youth karate practitioners on core endurance, agility, flexibility, sprinting, jumping, and kick performance. This study followed a randomized parallel design. Twenty-nine participants (age: 12.86 ± 0.81 years old; height: 152.55 ± 10.37 cm; weight: 42.93 ± 8.85 kg) were allocated to a CST programme ( n  = 16) performed thrice weekly or to a control group ( n  = 13) only performing the sport-specific (karate) training. Participants were assessed three times (baseline, mid and post-intervention) for the following tests: (i) flexor endurance test (FET); (ii) back extensor test (BET); (iii) lateral musculature test (LMT); (iv) flexibility; (v) chance of direction (COD); (vi) countermovement jump (CMJ); (vii) back muscle strength (BMS); (viii) horizontal jump (LJ); (ix) sprint test; and (x) karate kick test (KKT). Between-group analysis revealed significant advantages for the CST group on the FET ( p  &lt; 0.001), BET ( p  &lt; 0.001), LMT ( p  &lt; 0.001), 20 m sprint ( p  = 0.021) and KKT for right ( p  &lt; 0.006) and left ( p  &lt; 0.020) legs. No significant differences were found between groups in the remaining physical fitness variables ( p  &gt; 0.05). The within-group changes revealed significant improvements in the CST group at flexibility ( p  = 0.002), COD ( p  &lt; 0.001), CMJ ( p  &lt; 0.001), BMS ( p  &lt; 0.002), 20 m sprint ( p  = 0.033), and KKT ( p  &lt; 0.001). In addition, within-group changes in the control group were also significant in flexibility ( p  = 0.024) and right kick ( p  &lt; 0.042). We conclude that the CST programme improves core endurance and karate kick performance; however, it is not effective enough for other physical performance parameters in KR practitioners.",2022,"Between-group analysis revealed significant advantages for the CST group on the FET ( p  &lt; 0.001), BET ( p  &lt; 0.001), LMT ( p  &lt; 0.001), 20 m sprint ( p  = 0.021) and KKT for right ( p  &lt; 0.006) and left ( p  &lt; 0.020) legs.","['youth karate practitioners', 'Twenty-nine participants (age: 12.86 ± 0.81 years old; height: 152.55 ± 10.37 cm; weight: 42.93 ± 8.85 kg', 'Youth Karate Athletes']","['control group ( n  = 13) only performing the sport-specific (karate) training', '8-week core strength training (CST) programme', 'CST programme', 'flexor endurance test (FET', 'CST', 'Core Training']","['core endurance, agility, flexibility, sprinting, jumping, and kick performance', 'iv) flexibility; (v) chance of direction (COD); (vi) countermovement jump (CMJ); (vii) back muscle strength (BMS); (viii) horizontal jump (LJ); (ix) sprint test; and (x) karate kick test (KKT', 'BMS', 'CMJ', 'ii) back extensor test (BET); (iii) lateral musculature test (LMT', 'flexibility', 'LMT', 'remaining physical fitness variables', 'right kick', 'core endurance and karate kick performance', 'COD']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0079654', 'cui_str': 'Karate'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0643582', 'cui_str': '11-(2-fluoroethyl)estradiol'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079654', 'cui_str': 'Karate'}, {'cui': 'C0166552', 'cui_str': 'kamikihi-to'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}]",29.0,0.0369736,"Between-group analysis revealed significant advantages for the CST group on the FET ( p  &lt; 0.001), BET ( p  &lt; 0.001), LMT ( p  &lt; 0.001), 20 m sprint ( p  = 0.021) and KKT for right ( p  &lt; 0.006) and left ( p  &lt; 0.020) legs.","[{'ForeName': 'Menderes', 'Initials': 'M', 'LastName': 'Kabadayı', 'Affiliation': 'Faculty of Yaşar Doğu Sport Sciences, Ondokuz Mayıs University, Samsun 55270, Turkey.'}, {'ForeName': 'Soner', 'Initials': 'S', 'LastName': 'Karadeniz', 'Affiliation': 'Faculty of Yaşar Doğu Sport Sciences, Ondokuz Mayıs University, Samsun 55270, Turkey.'}, {'ForeName': 'Ali Kerim', 'Initials': 'AK', 'LastName': 'Yılmaz', 'Affiliation': 'Faculty of Yaşar Doğu Sport Sciences, Ondokuz Mayıs University, Samsun 55270, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Karaduman', 'Affiliation': 'Faculty of Yaşar Doğu Sport Sciences, Ondokuz Mayıs University, Samsun 55270, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Bostancı', 'Affiliation': 'Faculty of Yaşar Doğu Sport Sciences, Ondokuz Mayıs University, Samsun 55270, Turkey.'}, {'ForeName': 'Zeki', 'Initials': 'Z', 'LastName': 'Akyildiz', 'Affiliation': 'Faculty of Sport Sciences, Gazi University, Ankara 06500, Turkey.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Ana Filipa', 'Initials': 'AF', 'LastName': 'Silva', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}]",International journal of environmental research and public health,['10.3390/ijerph19105816']
1210,35627855,The Impact of Robotic Therapy on the Self-Perception of Upper Limb Function in Cervical Spinal Cord Injury: A Pilot Randomized Controlled Trial.,"BACKGROUND


The aim of the present study was to evaluate the impact of robotic therapy in patients with cervical spinal cord injury (SCI), measured on the basis of the patients' self-perception of limited upper limb function and level of independence in activities of daily living.
METHODS


Twenty-six patients with cervical SCI completed the treatment after being randomly assigned to the intervention or control group. The training consisted of 40 experimental sessions 1 h in duration, ideally occurring 5 days/week for 8 weeks. In addition to the conventional daily therapy (30 min), the control group received another 30 min of conventional therapy, whereas the intervention group received 30 min of robotic therapy. Patients were evaluated by means of the Capabilities of Upper Extremity Questionnaire (CUE) and Spinal Cord Independence Measure (SCIM) clinical scales.
RESULTS


The improvement in the feeding item of SCIM was significantly higher in the intervention group than in the control group after the treatment (2.00 (0.91) vs. 1.18 (0.89),  p  = 0.03). The correlation between the CUE and SCIM scales was higher at the ending than at baseline for both groups.
CONCLUSIONS


Although both groups improved, the clinical relevance related to the changes observed for both assessments was slightly higher in the intervention group than in the control group.",2022,"Although both groups improved, the clinical relevance related to the changes observed for both assessments was slightly higher in the intervention group than in the control group.","['Twenty-six patients with cervical SCI', 'patients with cervical spinal cord injury (SCI', 'Cervical Spinal Cord Injury']","['robotic therapy', 'Robotic Therapy']","['CUE and SCIM scales', 'feeding item of SCIM', 'Capabilities of Upper Extremity Questionnaire (CUE) and Spinal Cord Independence Measure (SCIM) clinical scales']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",26.0,0.0241505,"Although both groups improved, the clinical relevance related to the changes observed for both assessments was slightly higher in the intervention group than in the control group.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lozano-Berrio', 'Affiliation': 'Biomechanics and Technical Aids Department, National Hospital for Spinal Cord Injury, 45004 Toledo, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Alcobendas-Maestro', 'Affiliation': 'Biomechanics and Technical Aids Department, National Hospital for Spinal Cord Injury, 45004 Toledo, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Polonio-López', 'Affiliation': 'Technological Innovation Applied to Health Research Group (ITAS), Faculty of Health Sciences, University of Castilla-La Mancha, 45600 Talavera de la Reina, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gil-Agudo', 'Affiliation': 'Biomechanics and Technical Aids Department, National Hospital for Spinal Cord Injury, 45004 Toledo, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de la Peña-González', 'Affiliation': 'Occupational Therapy Unit, National Hospital for Spinal Cord Injury, 45004 Toledo, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Los Reyes-Guzmán', 'Affiliation': 'Biomechanics and Technical Aids Department, National Hospital for Spinal Cord Injury, 45004 Toledo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19106321']
1211,35627829,Penetration and Adaptation of the Highly Viscous Zinc-Reinforced Glass Ionomer Cement on Contaminated Fissures: An In Vitro Study with SEM Analysis.,"OBJECTIVE


We evaluate the penetration and adaptation of highly viscous zinc-reinforced glass ionomer cement (ZRGIC), using a scanning electron microscope (SEM), when applied under various contaminated conditions on grooves and fissures of primary second molars.
MATERIALS AND METHODS


A total of 40 extracted human primary second molars were randomly assigned into five groups (8 teeth each), with different surface conditions (conditioned with 40% polyacrylic acid, dry condition, water contamination, saliva contamination, or saliva contamination and air-drying) on the occlusal surface before placement of zinc-reinforced highly viscous glass ionomer cement with the finger-press technique. After sectioning the teeth, they were subjected to SEM analysis, where four in each group underwent aging by thermocycling and the other four were without aging. ANOVA tests, post hoc analysis, and unpaired t-tests were used for statistical analyses.
RESULTS


There was a significant statistical difference in the sealant penetration in the non-aging group, but in the aging group, there was no significant statistical difference in the sealant penetration. On other hand, a significant statistical difference was found in the adaptation between all the groups ( p  &lt; 0.05). Highly viscous zinc-reinforced glass ionomer fissure sealants have better fissure penetration and more intimate adaptation under fissures conditioned with 40% polyacrylic acid and dry surface fissures with no contamination. However, the best penetration and retention after aging were under contaminated fissures with a shiny layer of saliva.
CONCLUSIONS


Based on this study, we conclude that ZRGIC, a highly viscous fluoride-releasing cement, effectively seals fissures by interfering with food lodgment and protecting teeth from caries. We also conclude from this research that although the contaminated surfaces are not fully effective in penetrating and adapting the GIC to the tooth surface, they are still adequate for the brief period that will delay the carious process. It is advisable to restore the fissures with the minimal technique of sensitive fluoride-releasing GIC, particularly in young, uncooperative children, rather than leaving a caries-prone environment.",2022,Highly viscous zinc-reinforced glass ionomer fissure sealants have better fissure penetration and more intimate adaptation under fissures conditioned with 40% polyacrylic acid and dry surface fissures with no contamination.,"['40 extracted human primary second molars', 'Contaminated Fissures']","['highly viscous zinc-reinforced glass ionomer cement (ZRGIC', 'zinc-reinforced highly viscous glass ionomer cement with the finger-press technique', 'ZRGIC', 'surface conditions (conditioned with 40% polyacrylic acid, dry condition, water contamination, saliva contamination, or saliva contamination and air-drying', 'scanning electron microscope (SEM']",['sealant penetration'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0054720', 'cui_str': 'Carbomer-940'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0043056', 'cui_str': 'Water pollution'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181845', 'cui_str': 'Electron microscope'}]","[{'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}]",40.0,0.0272919,Highly viscous zinc-reinforced glass ionomer fissure sealants have better fissure penetration and more intimate adaptation under fissures conditioned with 40% polyacrylic acid and dry surface fissures with no contamination.,"[{'ForeName': 'Galiah Husam', 'Initials': 'GH', 'LastName': 'AlJefri', 'Affiliation': 'Private Practitioner, Pediatric Dentistry, Riyadh 11614, Saudi Arabia.'}, {'ForeName': 'Sunil Babu', 'Initials': 'SB', 'LastName': 'Kotha', 'Affiliation': 'Pediatric Dentistry Division, Preventive Dentistry Department, College of Dentistry, Riyadh Elm University (REU), Riyadh 13244, Saudi Arabia.'}, {'ForeName': 'Muhannad Hani', 'Initials': 'MH', 'LastName': 'Murad', 'Affiliation': 'Prince Salman bin Muhammad Hospital, Ministry of Health, Ad Dilam Governorate, Riyadh 16223, Saudi Arabia.'}, {'ForeName': 'Reham Mohammed', 'Initials': 'RM', 'LastName': 'Aljudaibi', 'Affiliation': 'Pediatric Dentistry Division, Preventive Dentistry Department, College of Dentistry, Riyadh Elm University (REU), Riyadh 13244, Saudi Arabia.'}, {'ForeName': 'Fatmah Nasser', 'Initials': 'FN', 'LastName': 'Almotawah', 'Affiliation': 'Pediatric Dentistry Division, Preventive Dentistry Department, College of Dentistry, Riyadh Elm University (REU), Riyadh 13244, Saudi Arabia.'}, {'ForeName': 'Sreekanth Kumar', 'Initials': 'SK', 'LastName': 'Mallineni', 'Affiliation': 'Department of Preventive Science, College of Dentistry, Majmaah University, Almajmaah 11952, Saudi Arabia.'}]",International journal of environmental research and public health,['10.3390/ijerph19106291']
1212,35627807,Functional Outcomes in a Randomized Controlled Trial of Animal-Assisted Therapy on Middle-Aged and Older Adults with Schizophrenia.,"Deficits in cognition, physical, and social functions in adults with schizophrenia may become salient with aging. While animal-assisted therapy (AAT) can benefit physical function in older adults and improve symptoms of psychotic disorders, the effect of AAT on middle-aged patients with schizophrenia is unclear. The current randomized controlled trial aimed to explore the efficacy of AAT for middle-aged patients with schizophrenia. Forty participants were randomly assigned to either the AAT or control group. The AAT group participated in one-hour sessions with dog-assisted group activities once a week for 12 weeks. The controls participated in dose-matched, non-animal-related recreational activities. Both groups remained on their usual psychotropic medication during the trial. Evaluations included the Chair Stand Test (CST), Timed Up-and-Go (TUG) test, Montreal Cognitive Assessment (MoCA), 5-Meter walk test (5MWT), and Assessment of Communication and Interaction Skills (ACIS). The increases in CST repetitions and ACIS scores were larger in the AAT group than in the controls. The two groups did not differ significantly in MoCA scores, TUG performance, or the 5MWT. The AAT group showed a greater increase in lower extremity strength and social skills, but no improvement in cognitive function, agility, or mobility. Further research with more sensitive evaluations and longer follow-up is needed.",2022,"The AAT group showed a greater increase in lower extremity strength and social skills, but no improvement in cognitive function, agility, or mobility.","['Forty participants', 'middle-aged patients with schizophrenia', 'Middle-Aged and Older Adults with Schizophrenia', 'adults with schizophrenia', 'older adults']","['animal-assisted therapy (AAT', 'AAT', 'Animal-Assisted Therapy', 'AAT or control group']","['MoCA scores, TUG performance, or the 5MWT', 'cognitive function, agility, or mobility', 'lower extremity strength and social skills', '5-Meter walk test (5MWT), and Assessment of Communication and Interaction Skills (ACIS', 'Deficits in cognition, physical, and social functions', 'Chair Stand Test (CST), Timed Up-and-Go (TUG) test, Montreal Cognitive Assessment (MoCA', 'CST repetitions and ACIS scores']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0150133', 'cui_str': 'Animal-assisted therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0412451,"The AAT group showed a greater increase in lower extremity strength and social skills, but no improvement in cognitive function, agility, or mobility.","[{'ForeName': 'Chyi-Rong', 'Initials': 'CR', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung 833401, Taiwan.'}, {'ForeName': 'Chi-Fa', 'Initials': 'CF', 'LastName': 'Hung', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung 833401, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung 833401, Taiwan.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Tseng', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung 833401, Taiwan.'}, {'ForeName': 'Mei-Li', 'Initials': 'ML', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei 112303, Taiwan.'}, {'ForeName': 'Tzu-Ting', 'Initials': 'TT', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Kaohsiung 833401, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19106270']
1213,35627765,"Changes in Salivary Immunoglobulin A, Stress, and Burnout in a Workplace Mindfulness Intervention: A Pilot Study.","The purpose of this pilot study was to examine the effectiveness of a 6-week workplace mindfulness- and self-compassion-based intervention (MSCBI) on perceived stress, burnout, immune functioning (assessed with the biomarker Immunoglobulin A), self-compassion, and experiential avoidance compared to a Workplace Stress Management Intervention. Both interventions were contextual, i.e., they were carried out in the workplace setting and during working hours. We followed a randomised controlled trial study design. The total sample was composed of 24 employees of an automotive company. One-way analyses of covariance between groups revealed significant differences in post-intervention levels of perceived stress, salivary Immunoglobulin A (sIgA), emotional exhaustion, self-compassion, and experiential avoidance, after adjusting for pre-test scores. The results of this study have several implications. Firstly, it confirms that MSCBIs might be more effective than regular psychoeducational interventions for work-related stress and burnout treatment. Secondly, sIgA can be used to assess immune function state changes when MSCBIs are carried out. Furthermore, these results indicate that it is feasible to carry out MSCBIs within companies and during working hours, and that these interventions can help effectively manage stress and burnout associated with the work environment.",2022,"One-way analyses of covariance between groups revealed significant differences in post-intervention levels of perceived stress, salivary Immunoglobulin A (sIgA), emotional exhaustion, self-compassion, and experiential avoidance, after adjusting for pre-test scores.",['24 employees of an automotive company'],"['6-week workplace mindfulness- and self-compassion-based intervention (MSCBI', 'Workplace Stress Management Intervention', 'MSCBIs']","['post-intervention levels of perceived stress, salivary Immunoglobulin A (sIgA), emotional exhaustion, self-compassion, and experiential avoidance']","[{'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443735', 'cui_str': 'Salivary immunoglobulin A'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",,0.0218683,"One-way analyses of covariance between groups revealed significant differences in post-intervention levels of perceived stress, salivary Immunoglobulin A (sIgA), emotional exhaustion, self-compassion, and experiential avoidance, after adjusting for pre-test scores.","[{'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Martínez-Borrás', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Europea de Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Navarrete', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Europea de Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Bellosta-Batalla', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Europea de Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martínez-Brotóns', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Europea de Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martínez-Rubio', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Europea de Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19106226']
1214,35606818,"A randomized controlled trial to assess the efficacy of Parenting-STAIR in treating maternal PTSD to reduce maltreatment recidivism: protocol for the Safe Mothers, Safe Children study.","BACKGROUND


Child maltreatment recidivism substantially increases the likelihood of adverse life outcomes, but there is little evidence that family preservation services are effective at reducing recidivism. Mothers in child welfare have very high rates of trauma exposure; maternal post-traumatic stress disorder (PTSD) is an intervention target that has the potential to reduce abuse and neglect. The Safe Mothers, Safe Children (SMSC) intervention program involves the delivery of an innovative combination of interventions, including Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT). The combined intervention, Parenting-STAIR (P-STAIR), targets maternal PTSD and comorbid depression symptoms to reduce the adverse effects of PTSD on parenting, improve positive parenting skills, and prevent maltreatment recidivism.
METHODS


This study is a two-arm randomized controlled trial: P-STAIR (23 sessions) versus supportive counseling (23 sessions). Participants are mothers receiving child welfare family preservation services (FPS), with a child in the age range of 1-8 years old and meeting diagnostic criteria for PTSD (with/without depression). Clinical assessment occurs at pre-treatment (baseline), two in-treatment assessments (mid-assessment #1 after module 9 and mid-assessment #2 after module 15), post-treatment, and at a 6-month follow-up. Recidivism will be measured using the New York State Child Welfare Registry (NYSCWR). We will enroll a total of 220 participants over 4 years: half (N = 110) randomly assigned to the P-STAIR condition and half (N = 110) to the supportive counseling condition.
DISCUSSION


This is the first RCT to investigate the efficacy of P-STAIR. The findings for the trial have the potential to contribute to the expansion of evidence-based practices for maternal PTSD, maltreatment, and child welfare.",2022,"The Safe Mothers, Safe Children (SMSC) intervention program involves the delivery of an innovative combination of interventions, including Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT).","['Participants are mothers receiving child welfare family preservation services (FPS), with a child in the age range of 1-8 years old and meeting diagnostic criteria for PTSD (with/without depression', '220 participants over 4 years: half (N = 110) randomly assigned to the P-STAIR condition and half (N = 110) to the', 'Mothers in child welfare have very high rates of trauma exposure; maternal post-traumatic stress disorder (PTSD']","['supportive counseling condition', 'Parenting-STAIR', 'P-STAIR (23 sessions) versus supportive counseling', 'Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT']","['positive parenting skills, and prevent maltreatment recidivism']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C3697360', 'cui_str': 'Supportive counseling'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0556527', 'cui_str': 'Parenting skills training'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}]",220.0,0.0598502,"The Safe Mothers, Safe Children (SMSC) intervention program involves the delivery of an innovative combination of interventions, including Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lindsey', 'Affiliation': 'Silver School of Social Work, New York University, New York, NY, USA. michael.lindsey@nyu.edu.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Sullivan', 'Affiliation': 'Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Chemtob', 'Affiliation': 'Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Ancharski', 'Affiliation': 'McSilver Institute for Poverty Policy and Research, Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jaccard', 'Affiliation': 'Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'Marylène', 'Initials': 'M', 'LastName': 'Cloitre', 'Affiliation': 'Institute for Trauma and Stress, New York University Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Urquiza', 'Affiliation': 'CAARE Diagnostic & Treatment Center, Department of Pediatrics, University of California, Sacramento, CA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Timmer', 'Affiliation': 'CAARE Diagnostic & Treatment Center, Department of Pediatrics, University of California, Sacramento, CA, USA.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Okosi', 'Affiliation': 'McSilver Institute for Poverty Policy and Research, Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kaplan', 'Affiliation': 'McSilver Institute for Poverty Policy and Research, Silver School of Social Work, New York University, New York, NY, USA.'}]",Trials,['10.1186/s13063-022-06354-1']
1215,35609642,Return to work following pelvic reconstructive surgery: secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss trial.,"BACKGROUND


Patients' return to work is an important part of surgical counseling and quality of life.
OBJECTIVE


This study aimed to evaluate the pattern of patients' return to work and loss of productivity after pelvic reconstructive surgery.
STUDY DESIGN


This was a secondary analysis of the randomized controlled trial Operations and Pelvic Muscle Training in the Management of Apical Support Loss. The primary outcome was return to work defined by the answer to ""How many calendar weeks or workdays did you not go to work after the original prolapse surgery?"" Furthermore, loss of productivity included hours and days per week worked and discontinuation of paid work because of urogynecologic conditions. Moreover, predictors affecting the timing of return to work and loss of productivity were assessed.
RESULTS


Here, 180 patients (49%) were working before surgery. Of these patients, half returned to work 35 days after surgery, with 21 (13%) returning to work immediately after surgery and 43 (27%) returning to work within ≤2 weeks. The number of days missed did not differ between patients who underwent sacrospinous ligament fixation and those who underwent uterosacral ligament suspension (P=.23). At 3 months, 15 patients (9%) who were working before surgery had stopped working, but those who continued to work had similar hours per week as before surgery (36±12 vs 35±13; P=.48). Of note, 17 patients (11%) reported being less productive, on average working at 60% effectiveness. Most patients (96%) reported not missing any hours of household chores by 3 months after surgery. Patients who returned to work within 6 weeks had a higher rate of retreatment with either pessary or surgery within 2 years (5 of 85 [6.8%] vs 0 of 76 [0%]; P=.03). Those who returned to work within 2 weeks worked fewer hours before surgery (30±15 vs 36±12; P=.013), were less likely to have private insurance (77% vs 91%; P=.03), and had a higher rate of retreatment (3 of 30 [13%] vs 2 of 131 [1.7%]; P=.007). There was no difference in bulge symptoms and anatomic failure based on return to work.
CONCLUSION


Most patients returned to work within 35 days after surgery. Working less than full time and not having private insurance were predictors of earlier return to work.",2022,"Patients who returned to work within 6 weeks had a higher rate of retreatment with either pessary or surgery within 2 years (5 out of 85 (6.8%) vs. 0 out of 76 (0%), P=0.03).",[],"['sacrospinous ligament fixation', 'Pelvic Reconstructive Surgery', 'pelvic reconstructive surgery', 'Pelvic Muscle Training', 'uterosacral ligament suspension']","['private insurance', 'higher rate of retreatment with either pessary or surgery', 'return to work defined by the answer to ""How many calendar weeks or work days did you not go to work following the original prolapse surgery', 'bulge symptoms and anatomical failure based on return to work', 'timing of return to work and loss of productivity', 'higher rate of retreatment']",[],"[{'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0448421', 'cui_str': 'Skeletal muscle structure of pelvis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C1516147', 'cui_str': 'Calendars'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.116886,"Patients who returned to work within 6 weeks had a higher rate of retreatment with either pessary or surgery within 2 years (5 out of 85 (6.8%) vs. 0 out of 76 (0%), P=0.03).","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'Sappenfield', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Hartford Hospital, Hartford, CT. Electronic address: Elisabeth.Sappenfield@hhchealth.org.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2022.05.037']
1216,35609625,Perks of blindness: Enhanced verbal memory span in blind over sighted adults.,"Blind individuals commonly use verbal encoding (i.e. text-to-speech) and memory-based strategies (i.e. serial recall) for situations in which sighted individuals use vision (i.e. finding items). These strategies may serve to train cognitive systems responsible for maintaining and manipulating verbal information. To test this hypothesis, we investigate whether early visual deprivation is linked to improved verbal short-term and working memory abilities, and thus might illustrate experience-dependent plasticity in memory systems. We also test whether the sensory modality for encoding information influences performance. Our data show that blind adults recalled more items on a verbal short-term memory span task than sighted participants. Furthermore, blind individuals performed equally well on auditory forward and backward conditions despite the fact that recalling items in reverse order is more difficult for the general population. However, the benefits of recalling items in reverse order did not extend to the tactile domain, specifically, a braille version of the short-term memory digit span task in blind individuals. Furthermore, we observed no differences between blind and sighted individuals on a more demanding auditory n-back task evaluating more complex working memory processes. We conclude that the memory benefits associated with blindness might be restricted to auditory-verbal short-term memory and likely reflect strategy use and practice.",2022,"Furthermore, we observed no differences between blind and sighted individuals on a more demanding auditory n-back task evaluating more complex working memory processes.",['Blind over Sighted Adults'],[],"['demanding auditory n-back task evaluating more complex working memory processes', 'verbal short-term memory span task', 'Verbal Memory Span']","[{'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",,0.0561076,"Furthermore, we observed no differences between blind and sighted individuals on a more demanding auditory n-back task evaluating more complex working memory processes.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Arcos', 'Affiliation': 'Department of Cognitive Science, University of California, Irvine, 3151 Social Sciences Plaza, Irvine, CA 92697-5100, United States. Electronic address: karcos1@uci.edu.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Jaeggi', 'Affiliation': 'Department of Cognitive Science, University of California, Irvine, 3151 Social Sciences Plaza, Irvine, CA 92697-5100, United States; School of Education, University of California, Irvine, 3452 Education, Irvine, CA 92697-5500, United States. Electronic address: smjaeggi@uci.edu.'}, {'ForeName': 'Emily D', 'Initials': 'ED', 'LastName': 'Grossman', 'Affiliation': 'Department of Cognitive Science, University of California, Irvine, 3151 Social Sciences Plaza, Irvine, CA 92697-5100, United States. Electronic address: grossman@uci.edu.'}]",Brain research,['10.1016/j.brainres.2022.147943']
1217,35610603,Physical and mental health outcomes of an integrated cognitive behavioural and weight management therapy for people with an eating disorder characterized by binge eating and a high body mass index: a randomized controlled trial.,"BACKGROUND


Bulimia nervosa (BN) and binge eating disorder (BED) are eating disorders (EDs) characterized by recurrent binge eating. They are associated with medical complications, impaired adaptive function and often a high BMI, for which a multidisciplinary treatment approach may be needed. This study explored the efficacy of a novel intervention integrating Cognitive Behavioural Therapy- Enhanced (CBT-E) and weight management for people with recurrent binge eating episodes and high BMI with respect to physical, psychopathological and quality of life outcomes.
METHODS


Ninety-eight adults diagnosed with BN, BED, or Other Specified/Unspecified Feeding or Eating Disorder (OSFED/UFED) and BMI ≥ 27 to <40 kg/m 2  were randomized to a multidisciplinary approach, the Healthy APproach to weIght management and Food in Eating Disorders (HAPIFED) or to CBT-E. Metabolic parameters, health-related quality of life, general psychological and ED symptoms and ED diagnostic status outcomes are reported. Data were analyzed with mixed effects models adopting multiple imputed datasets where data were missing.
RESULTS


Both HAPIFED and CBT-E showed statistical significance for the time effect, with reduction in stress (p < 0.001), improvement in mental health-related quality of life (p = 0.032), reduction in binge eating severity (p < 0.001), and also in global ED symptoms scores (p < 0.001), with the significant changes found at end of treatment and sustained at 12-month follow-up. However, no statistical significance was found for differences between the interventions in any of the outcomes measured. Despite a high BMI, most participants (> 75%) had blood test results for glucose, insulin, triglycerides and cholesterol within the normal range, and 52% were within the normal range for the physical component of quality of life at baseline with no change during the trial period.
CONCLUSION


Integrating weight and ED management resulted in comparable outcomes to ED therapy alone. Although adding weight management to an ED intervention had no adverse effects on psychological outcomes, it also had no beneficial effect on metabolic outcomes. Therefore, more intense weight management strategies may be required where indicated to improve metabolic outcomes. Safety will need to be concurrently investigated.
TRIAL REGISTRATION


US National Institutes of Health clinical trial registration number NCT02464345 , date of registration 08/06/2015. Changes to the present paper from the published protocol paper (Trials 18:578, 2015) and as reported in the Trial registration (clinicaltrials.gov) are reported in Supplementary File 1.",2022,"Both HAPIFED and CBT-E showed statistical significance for the time effect, with reduction in stress (p < 0.001), improvement in mental health-related quality of life (p = 0.032), reduction in binge eating severity (p < 0.001), and also in global ED symptoms scores (p < 0.001), with the significant changes found at end of treatment and sustained at 12-month follow-up.","['Ninety-eight adults diagnosed with BN, BED, or Other Specified/Unspecified Feeding or Eating Disorder (OSFED/UFED) and BMI\u2009≥\u200927 to <40\u2009kg/m 2', 'people with recurrent binge eating episodes and high BMI', 'people with an eating disorder characterized by binge eating and a high body mass index']","['multidisciplinary approach, the Healthy APproach to weIght management and Food in Eating Disorders (HAPIFED) or to CBT-E. Metabolic parameters, health-related', 'novel intervention integrating Cognitive Behavioural Therapy- Enhanced (CBT-E) and weight management', 'integrated cognitive behavioural and weight management therapy']","['global ED symptoms scores', 'binge eating severity', 'mental health-related quality of life', 'quality of life, general psychological and ED symptoms and ED diagnostic status outcomes', 'metabolic outcomes', 'blood test results for glucose, insulin, triglycerides and cholesterol']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",98.0,0.0709318,"Both HAPIFED and CBT-E showed statistical significance for the time effect, with reduction in stress (p < 0.001), improvement in mental health-related quality of life (p = 0.032), reduction in binge eating severity (p < 0.001), and also in global ED symptoms scores (p < 0.001), with the significant changes found at end of treatment and sustained at 12-month follow-up.","[{'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Hay', 'Affiliation': 'School of Medicine, Translational Health Research Institute, Western Sydney University, 1797 Locked Bag Avenue, Sydney, 2751, Australia. p.hay@westernsydney.edu.au.'}, {'ForeName': 'Marly Amorim', 'Initials': 'MA', 'LastName': 'Palavras', 'Affiliation': 'School of Medicine, Translational Health Research Institute, Western Sydney University, 1797 Locked Bag Avenue, Sydney, 2751, Australia.'}, {'ForeName': 'Felipe Quinto', 'Initials': 'FQ', 'LastName': 'da Luz', 'Affiliation': 'Eating Disorders Program (AMBULIM), Faculty of Medicine, Universidade de São Paulo (USP), Rua Dr. Ovídio Pires de Campos, 785, São Paulo, SP, 05403-010, Brazil.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Dos Anjos Garnes', 'Affiliation': 'Eating Disorders Program (PROATA), Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Rua Major Maragliano 241, São Paulo, SP, 04017-030, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sainsbury', 'Affiliation': 'School of Human Sciences, The University of Western Australia, Perth, 6009, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Touyz', 'Affiliation': 'Inside Out Institute and School of Psychology, Charles Perkins Centre, SLHD and The University of Sydney, Sydney, 2006, Australia.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Appolinario', 'Affiliation': 'Obesity and Eating Disorders Group - Institute of Psychiatry, Federal University of Rio de Janeiro (UFRJ), Avenida Pedro Calmon 550, Rio de Janeiro, RJ, 21941-901, Brazil.'}, {'ForeName': 'Angélica Medeiros', 'Initials': 'AM', 'LastName': 'Claudino', 'Affiliation': 'Eating Disorders Program (PROATA), Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Rua Major Maragliano 241, São Paulo, SP, 04017-030, Brazil.'}]",BMC psychiatry,['10.1186/s12888-022-04005-y']
1218,35610581,Anticipatory care planning for community-dwelling older adults at risk of functional decline: a feasibility cluster randomized controlled trial.,"OBJECTIVES


To determine the feasibility, implementation and outcomes of an Anticipatory Care Planning (ACP) intervention in primary care to assist older adults at risk of functional decline by developing a personalized support plan.
DESIGN


Feasibility cluster randomized control trial.
SETTING AND PARTICIPANTS


Eight primary care practices (four in Northern Ireland, United Kingdom and four in the Republic of Ireland) were randomly assigned to either intervention or control arm. Eligible patients were those identified in each practice as 70 years of age or older and assessed as at risk of functional decline. Study participants (intervention n = 34, control n = 31) and research staff were not blinded to group assignment.
ANTICIPATORY CARE INTERVENTION


The intervention delivered by a registered nurse including: a) a home-based patient assessment; b) care planning on the basis of a holistic patient assessment, and c) documentation of a support plan.
OUTCOME MEASURES


A conceptual framework (RE-AIM) guided the assessment on the potential impact of the ACP intervention on patient quality of life, mental health, healthcare utilisation, costs, perception of person-centred care, and reduction of potentially inappropriate prescribing. Data were collected at baseline and at 10 weeks and six months following delivery of the intervention.
RESULTS


All pre-specified feasibility indicators were met. Patients were unanimous in the acceptance of the ACP intervention. Health care providers viewed the ACP intervention as feasible to implement in routine clinical practice with attending community supports. While there were no significant differences on the primary outcomes (EQ-5D-5L: -0.07 (-0.17, 0.04) p = .180; CES-D: 1.2 (-2.5, 4.8) p = .468) and most secondary measures, ancillary analysis on social support showed responsiveness to the intervention. Incremental cost analysis revealed a mean reduction in costs of €320 per patient (95% CI -31 to 25; p = 0.82) for intervention relative to the control.
CONCLUSIONS


We successfully tested the ACP intervention in primary care settings and have shown that it is feasible to implement. The ACP intervention deserves further testing in a definitive trial to determine whether its implementation would lead to better outcomes or reduced costs.
TRIAL REGISTRATION


Clinicaltrials.gov, ID: NCT03902743 . Registered on 4 April 2019.",2022,"Incremental cost analysis revealed a mean reduction in costs of €320 per patient (95% CI -31 to 25; p = 0.82) for intervention relative to the control.
","['primary care to assist older adults at risk of functional decline by developing a personalized support plan', 'Eight primary care practices (four in Northern Ireland, United Kingdom and four in the Republic of Ireland', 'Study participants (intervention n\u2009=\u200934, control n\u2009=\u200931) and research staff', 'Eligible patients were those identified in each practice as 70\xa0years of age or older and assessed as at risk of functional decline', 'community-dwelling older adults at risk of functional decline']","['Anticipatory Care Planning (ACP) intervention', 'ACP intervention', 'home-based patient assessment; b) care planning on the basis of a holistic patient assessment, and c) documentation of a support plan', 'Anticipatory care planning']","['patient quality of life, mental health, healthcare utilisation, costs, perception of person-centred care, and reduction of potentially inappropriate prescribing']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}]",,0.183937,"Incremental cost analysis revealed a mean reduction in costs of €320 per patient (95% CI -31 to 25; p = 0.82) for intervention relative to the control.
","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Brazil', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK. k.brazil@qub.ac.uk.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cardwell', 'Affiliation': ""Centre for Public Health, ICSB, Royal Victoria Hospital, Queen's University, Belfast, UK.""}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Carter', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Centre for Public Health, ICSB, Royal Victoria Hospital, Queen's University, Belfast, UK.""}, {'ForeName': 'Dagmar Anna S', 'Initials': 'DAS', 'LastName': 'Corry', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Fahey', 'Affiliation': 'Department of General Practice, RCSI University of Medicine and Health Sciences, Dublin, Republic of Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Gillespie', 'Affiliation': 'Health Economics and Policy Analysis Centre, Institute for Lifecourse and Society, National University of Ireland, Galway (NUI Galway), Republic of Ireland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hobbins', 'Affiliation': 'Health Economics and Policy Analysis Centre, Institute for Lifecourse and Society, National University of Ireland, Galway (NUI Galway), Republic of Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'McGlade', 'Affiliation': ""School of Medicine, Dentistry, and Biomedical Sciences, Dunluce Health Centre, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': ""O'Neill"", 'Affiliation': ""School of Social Sciences, Education and Social Work, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wallace', 'Affiliation': 'Department of General Practice, RCSI University of Medicine and Health Sciences, Dublin, Republic of Ireland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Doyle', 'Affiliation': 'Department of Health Psychology, RCSI University of Medicine and Health Sciences, Dublin, Republic of Ireland.'}]",BMC geriatrics,['10.1186/s12877-022-03128-x']
1219,35612469,"Visualization, Self-Efficacy, and Locus of Control in a Virtual Reality Biofeedback Video Game for Anxiety Regulation.","The current study aimed to identify specific feedback mechanics and psychological processes that may contribute to positive outcomes in biofeedback applications for anxiety regulation. Specifically, using a dismantling study design, the unique impact of visualizations that directly mirror users' breathing was examined in relation to anxiety regulation as well as locus of control and self-efficacy. Following an anxiety induction, participants ( N  = 67) were randomly assigned to play one of two variations of a biofeedback video game. In both versions, players' in-game movement was contingent on their breathing; however, the experimental condition additionally included visualizations that directly mirrored players' breathing. Changes in self-reported state anxiety and physiological arousal were measured as well as the level of internal control and self-efficacy participants experienced while playing the game. Results showed that all participants were able to effectively reduce their anxiety and arousal, but no condition differences were found. Implementing mirroring visualizations did not contribute to individuals' ability to self-regulate nor their self-efficacy or locus of control above and beyond receiving feedback based on their in-game movement. Overall, individuals who experienced higher self-efficacy and a stronger internal locus of control were better able to regulate their anxiety, but no clear links were found with changes in self-reported physiological arousal. In light of these results, we recommend the continued exploration of the role of specific design choices and intervention components as well as underlying mechanisms of change in biofeedback interventions, especially pertaining to how individuals perceive themselves and their ability to change.",2022,Implementing mirroring visualizations did not contribute to individuals' ability to self-regulate nor their self-efficacy or locus of control above and beyond receiving feedback based on their in-game movement.,['participants ( N \u2009=\u200967'],['biofeedback video game'],"['anxiety and arousal', 'Visualization, Self-Efficacy, and Locus of Control', 'state anxiety and physiological arousal']",[],"[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",67.0,0.0385434,Implementing mirroring visualizations did not contribute to individuals' ability to self-regulate nor their self-efficacy or locus of control above and beyond receiving feedback based on their in-game movement.,"[{'ForeName': 'Joanneke', 'Initials': 'J', 'LastName': 'Weerdmeester', 'Affiliation': 'Orthopedagogics: Family and Behaviour, Faculty of Social Sciences, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Marieke M J W', 'Initials': 'MMJW', 'LastName': 'van Rooij', 'Affiliation': 'Research Support Office, Faculty of Behavioural, Management and Social Sciences, University of Twente, Enschede, Netherlands.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Granic', 'Affiliation': 'Health, Aging & Society, Faculty of Social Sciences, McMaster University, Hamilton, Ontario, Canada.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2022.0030']
1220,35614405,"Hysteroscopic management versus ultrasound-guided evacuation for women with first-trimester pregnancy loss, a randomised controlled trial.","OBJECTIVE


We aimed to evaluate the hysteroscopic management of first-trimester pregnancy loss compared to surgical evacuation either blind or under ultrasonographic guidance‎.
METHODS


This clinical trial included ‎315 women with first-trimester pregnancy loss, divided equally into three groups. Group 1 underwent traditional blind surgical evacuation, group 2 underwent ultrasound-guided evacuation, and group 3 underwent hysteroscopic management. All women were assessed for retained products, surgical complications, the need for further management, and pregnancy occurrence after evacuation within 2 years of follow up.
RESULTS


The rate of presence of conception remnants and the need for further ‎treatment was significantly higher in group 1 compared to groups 2 and 3 (4.8% vs. 0% vs. 0%, P = 0.012). The conception rate within 2 years was significantly lower in group 1 compared to groups 2 and 3 (57.4% vs. 73.2% vs. 82.7%, P = 0.002), and the duration needed to conceive was significantly prolonged in group 1 compared to groups 2 and 3 (9.8 vs. 8.3 vs. 6.9 months, P < 0.001). Interestingly, women who underwent hysteroscopic management needed a significantly shorter time to conceive than those who underwent ultrasound-guided evacuation‎ (6.9 vs. 8.3 months, P = 0.006).
CONCLUSIONS


Hysteroscopic management of first-trimester pregnancy loss was superior to ultrasound-guided surgical evacuation regarding the time interval to conceive. Both techniques were superior to the blind evacuation technique regarding removal of the whole conception remnants, need for further treatment and fertility outcomes. Clinical trial registration: It was first registered at ClinicalTrials.gov on 16/03/2017 with registration number NCT03081104.",2022,"Both techniques were superior to the blind evacuation technique regarding removal of the whole conception remnants, need for further treatment and fertility outcomes.","['women with first-trimester pregnancy loss', '\u200e315 women with first-trimester pregnancy loss, divided equally into three groups']","['surgical evacuation either blind or under ultrasonographic guidance\u200e', 'traditional blind surgical evacuation, group 2 underwent ultrasound-guided evacuation, and group 3 underwent hysteroscopic management', 'Hysteroscopic management versus ultrasound-guided evacuation']","['shorter time to conceive', 'rate of presence of conception remnants and the need for further \u200etreatment', 'conception rate', 'duration needed to conceive']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",,0.051991,"Both techniques were superior to the blind evacuation technique regarding removal of the whole conception remnants, need for further treatment and fertility outcomes.","[{'ForeName': 'Hadeer', 'Initials': 'H', 'LastName': 'Meshaal', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Salah', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Fawzy', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Abdel-Rasheed', 'Affiliation': 'Reproductive Health Research Department, National Research Centre, 33 El-Buhouth St, Dokki, Cairo, 12622, Egypt. doctor_mazen@hotmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Maged', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Saad', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",BMC women's health,['10.1186/s12905-022-01774-2']
1221,35613989,Effect of S-ketamine on Postoperative Quality of Recovery in Patients Undergoing Video-Assisted Thoracic Surgery.,"OBJECTIVES


S-ketamine is associated with effective postoperative analgesia and enhanced quality of recovery (QoR). The study aimed to investigate the effect of perioperative S-ketamine on postoperative quality of recovery in patients undergoing video-assisted thoracic surgery (VATS).
DESIGN


A prospective, randomized, double-blinded, placebo-controlled trial.
SETTING


Single institution, tertiary university hospital.
PARTICIPANTS


Eighty adult patients aged 18-to-65 undergoing VATS were eligible for participation.
INTERVENTIONS


Patients enrolled in this study were randomized to receive either S-ketamine (a bolus of 0.25 mg/kg, followed by an infusion of 0.125 mg/kg/h until 15 minutes before the end of the surgical procedure), or identical volumes and rates of 0.9% saline.
MEASUREMENTS AND MAIN RESULTS


Postoperative quality of recovery was measured with QoR-40 score 48 hours after surgery. The postoperative pain was assessed postoperatively using the numeric rating scale at 0.5, 6, 24, and 48 hours. Hospital Anxiety and Depression Scale Depression subscale (HADS-D) scores and other secondary outcomes also were recorded. The final analysis included 77 patients. The global QoR-40 score at 48 hours postoperatively was higher in the S-ketamine group compared with the saline group (median [interquartile range]: 181.5 [178-184] v 174.5 [169-177]), estimated median difference 7 (95% confidence interval 5-10, p < 0.001). Patients who received S-ketamine treatment had lower pain scores at rest (p = 0.017 and p = 0.006, respectively) and coughing (p < 0.001 and p = 0.007, respectively) at 24 and 48 hours postoperatively than those who received saline treatment. The requirement and consumption of opioid for rescue analgesic were lower in the S-ketamine (p = 0.045 and p = 0.047, respectively). Compared with the saline group, S-ketamine reduced HADS-D scores (p = 0.003) at 48 hours after surgery.
CONCLUSIONS


The present study's findings suggested that perioperative S-ketamine enhanced the quality of recovery in patients undergoing VATS. S-ketamine also improved postoperative analgesia and postoperative depression.",2022,"Compared with the saline group, S-ketamine reduced HADS-D scores (p = 0.003) at 48 hours after surgery.
","['Patients Undergoing Video-Assisted Thoracic Surgery', 'patients undergoing video-assisted thoracic surgery (VATS', 'patients undergoing VATS', 'Eighty adult patients aged 18-to-65 undergoing VATS were eligible for participation', '77 patients', 'Single institution, tertiary university hospital']","['ketamine', 'S-ketamine', 'placebo', 'perioperative S-ketamine']","['quality of recovery (QoR', 'requirement and consumption of opioid for rescue analgesic', 'postoperative quality of recovery', 'postoperative pain', 'Postoperative quality of recovery', 'Hospital Anxiety and Depression Scale Depression subscale (HADS-D) scores', 'HADS-D scores', 'postoperative analgesia and postoperative depression', 'coughing', 'Postoperative Quality of Recovery', 'lower pain scores', 'global QoR-40 score', 'quality of recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0362037', 'cui_str': 'Postoperative depression'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",80.0,0.87951,"Compared with the saline group, S-ketamine reduced HADS-D scores (p = 0.003) at 48 hours after surgery.
","[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Diao', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China. Electronic address: jiaohaoyishi@139.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2022.04.028']
1222,35614523,"Examining smoking and vaping behaviors, expectancies, and cessation outcomes between bisexual and heterosexual individuals.","Prior research indicates bisexual individuals have higher smoking and vaping rates and heightened vulnerability to negative health outcomes. Thus, we compared adult bisexual ( n  = 294) and heterosexual ( n  = 2412) participants enrolled in a smoking cessation trial on baseline smoking and vaping use behaviors, motivations, and expectancies/beliefs as well as follow-up smoking and vaping status. This is a secondary analysis of a large randomized controlled trial testing a smoking cessation intervention for dual users of combustible and electronic cigarettes (e-cigarettes) in the United States. Self-reported 7-day point prevalence smoking and vaping abstinence were collected at 3-, 12-, and 24-month assessments. Bisexual and heterosexual participants did not differ in sociodemographic variables or baseline smoking and vaping history and behavior. We found significant differences among bisexual and heterosexual individuals in smoking and vaping beliefs/expectancies. Specifically, bisexual participants expressed overall greater positive expectancies regarding smoking and vaping, such as smoking and vaping to reduce negative affect and stress. There were no differences in smoking at any follow-up assessment. Only at 3 months were bisexual individuals more likely to be abstinent from vaping and less likely to be dual users than heterosexual individuals. Despite similar smoking and vaping status over time, bisexual individuals reported greater positive expectancies regarding smoking and vaping. Our findings revealed few targets for tailoring cessation interventions to bisexual individuals; thus, it is possible that there may be greater utility in targeting the disparities in prevalence (i.e., via prevention efforts).",2022,"Despite similar smoking and vaping status over time, bisexual individuals reported greater positive expectancies regarding smoking and vaping.","['adult bisexual ( n \u2009=\u2009294) and heterosexual ( n \u2009=\u20092412) participants enrolled in a smoking cessation trial on baseline smoking and vaping use behaviors, motivations, and expectancies/beliefs as well as follow-up smoking and vaping status', 'dual users of combustible and electronic cigarettes (e-cigarettes) in the United States', 'bisexual and heterosexual individuals', 'Bisexual and heterosexual participants']",['smoking cessation intervention'],['Self-reported 7-day point prevalence smoking and vaping abstinence'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",2412.0,0.0891177,"Despite similar smoking and vaping status over time, bisexual individuals reported greater positive expectancies regarding smoking and vaping.","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Martinez', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center.'}, {'ForeName': 'Gwendolyn P', 'Initials': 'GP', 'LastName': 'Quinn', 'Affiliation': 'Deparment of Obstetrics and Gynecology, New York University Grossman School of Medicine.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2022.2077295']
1223,35615945,A Pilot Study of Patient Photographs and Handoff Communication.,"BACKGROUND AND OBJECTIVES


Safe and effective handoffs have become a national priority. Given that patient photographs have been associated with safety benefits in other settings, we hypothesize they could improve handoff communication. Our objective was to determine whether patient photographs used during simulated handoffs improves information retention, response to clinical scenarios, and familiarity with patients, compared with simulated handoffs without photographs.
METHODS


We conducted a pilot mixed-methods study using simulated handoff sessions with pediatric residents. One investigator simulated 2 verbal handoff sessions with participants randomized to receive stock patient photographs in either the first or second session. Participants answered an online questionnaire after each session to assess information recall and familiarity with patients. Primary outcomes included percent correct responses and response time. Participants were interviewed to assess the benefits and challenges of using photographs in handoffs.
RESULTS


Forty pediatric residents participated. Correct responses and response time did not differ significantly between sessions. Participants indicated less confusion and more comfort caring for patients after photograph handoff sessions. All participants identified benefits to using patient photographs and 75% identified challenges. Benefits included assisting memory, enhancing connection with patients, and improving patient safety. Challenges included visual distraction, bias concerns, and patient privacy.
CONCLUSIONS


In this pilot study, patient photographs did not result in improved information retention or efficiency of response to clinical scenarios but were associated with perceptions of reduced confusion and enhanced comfort. Participants identified benefits and challenges of incorporating photographs in handoffs that could inform use in real-world settings.",2022,"In this pilot study, patient photographs did not result in improved information retention or efficiency of response to clinical scenarios but were associated with perceptions of reduced confusion and enhanced comfort.","['Forty pediatric residents participated', 'pediatric residents']",[],"['confusion and more comfort caring', 'percent correct responses and response time', 'visual distraction, bias concerns, and patient privacy', 'patient safety', 'Correct responses and response time']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],"[{'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0305706,"In this pilot study, patient photographs did not result in improved information retention or efficiency of response to clinical scenarios but were associated with perceptions of reduced confusion and enhanced comfort.","[{'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Hughes', 'Affiliation': 'Division of General Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Laetitia X', 'Initials': 'LX', 'LastName': 'Zhang', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Psoter', 'Affiliation': 'Division of General Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Smith', 'Affiliation': 'Division of General Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Division of General Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Tschudy', 'Affiliation': ''}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Mph', 'Affiliation': 'Division of General Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Janet R', 'Initials': 'JR', 'LastName': 'Serwint', 'Affiliation': 'Division of General Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Hospital pediatrics,['10.1542/hpeds.2021-006399']
1224,35616436,"Predictors of abstinence, no heavy drinking days, and a 2-level reduction in World Health Organization drinking levels during treatment for alcohol use disorder in the COMBINE study.","BACKGROUND


Data from trials of medications for alcohol use disorder (AUD) can be used to identify predictors of drinking outcomes regardless of treatment, which can inform the design of future trials with heterogeneous populations. Here, we identified predictors of abstinence, no heavy drinking days, and a 2-level reduction in World Health Organization (WHO) drinking levels during treatment for AUD in the Combined Pharmacotherapies and Behavioral Interventions (COMBINE) Study.
METHODS


We utilized data from the COMBINE Study, a randomized placebo-controlled trial evaluating the efficacy of naltrexone and acamprosate, both alone and in combination, for AUD (n = 1168). A tree-based machine learning algorithm was used to construct classification trees predicting abstinence, no heavy drinking days, and a 2-level reduction in WHO drinking levels in the last 4 weeks of treatment, based on 89 baseline variables.
RESULTS


The final tree for predicting abstinence had one split based on consecutive days abstinent prior to randomization, with a higher proportion of subjects achieving abstinence among those classified as abstinent for >2 versus ≤2 consecutive weeks prior to randomization (66% vs. 29%). The final tree for predicting no heavy drinking days in the last 4 weeks of treatment had three splits based on consecutive days abstinent, age, and total Alcohol Dependence Scale score at baseline. Seventy-three percent of the subjects classified as abstinent for >2 consecutive weeks prior to randomization had no heavy drinking days in the last 4 weeks of treatment. Among those classified as abstinent ≤2 consecutive weeks prior, three additional splits showed that younger subjects (age ≤44 years; 37%), and older subjects (age >44) with a total Alcohol Dependence Scale score >13 and complete abstinence (56%) or other drinking goals (35%), were less likely to have no heavy drinking days than older subjects with a total Alcohol Dependence Scale score ≤13 (67%). The final tree for predicting a 2-level reduction in WHO levels had no splits.
CONCLUSIONS


Consecutive days abstinent prior to randomization may predict abstinence and no heavy drinking days and total Alcohol Dependence Scale score and age may predict no heavy drinking days. The 2-level reduction in WHO levels outcome may be less likely to discriminate based on multiple patient characteristics.",2022,"Here, we identified predictors of abstinence, no heavy drinking days, and a 2-level reduction in World Health Organization (WHO) drinking levels during treatment for AUD in the COMBINE Study.
",[],"['naltrexone and acamprosate, both alone and in combination, for AUD', 'placebo']","['2-level reduction in World Health Organization (WHO) drinking levels', 'WHO drinking levels', 'total Alcohol Dependence Scale score >\u200913 and complete abstinence', 'total Alcohol Dependence Scale score', 'heavy drinking days and total Alcohol Dependence Scale score']",[],"[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0284941', 'cui_str': 'acamprosate'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450984', 'cui_str': 'Alcohol dependence scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}]",,0.0746327,"Here, we identified predictors of abstinence, no heavy drinking days, and a 2-level reduction in World Health Organization (WHO) drinking levels during treatment for AUD in the COMBINE Study.
","[{'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Wallach', 'Affiliation': 'Department of Environmental Health Sciences, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Phan', 'Affiliation': 'Department of Statistics, University of Washington, Washington, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, Center on Alcohol, Substance Use, and Addictions, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Yale Medical School, New Haven, Connecticut, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale Medical School, New Haven, Connecticut, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14877']
1225,35617846,Effectiveness of a process-based executive function intervention on arithmetic knowledge of children with Developmental Dyscalculia.,"BACKGROUND


Arithmetic knowledge has long been known as an essential factor for educational and vocational success.
AIMS


This study aims to explore the effectiveness of a process-based Executive Function (EF) intervention program on the improvement of components of arithmetic.
METHODS AND PROCEDURE


A goal-directed sampling method was applied in this study. Participants were assigned into active control and experimental groups. Semi-experimental design with pre-test, post-test and follow-up was utilized in this research. Participants were included in this study based on their WISC-IV and Key-Math test performance. 30 male students aged 8-10 years with a formal diagnosis of Developmental Dyscalculia (DD), selected from a learning disability center in Ahvaz, Iran, participated in the study. The pre-test took 1 month, the intervention including 17 sessions, took two months and the post-test took 1 month. All the students' arithmetic knowledge were tested in pre-test, post-test, and 3 months after post-test to test the longevity of the intervention effects. Repeated measure Univariate Analysis of Variance was conducted in this study.
OUTCOMES AND RESULTS


The results indicate that the students who attended the intervention, outperformed control group in the components of factual and procedural arithmetic in post-test and follow-up, however; the performance of two groups in conceptual knowledge was not different. This study contributes to the emerging evidence that EF intervention may improve factual and procedural arithmetic knowledge in children with DD.
CONCLUSIONS AND IMPLICATIONS


Process-based EF interventions can improve arithmetic knowledge of students with DD, which can contribute to the literature of this area WHAT THIS PAPER ADDS?: The current research helps cognitive science to present a more meticulous theoretical and conceptual pattern for EF components and math, using process-based EF intervention programs with arithmetic content. Furthermore, this research allows for specification of cognitive fundamentals of arithmetic development and understanding the mechanisms underlying the transfer effect of EF intervention to math. The findings of this research can contribute to evidence-based EF intervention studies and help educational psychologists in preparation of appropriate curricula based on the fundamental components of arithmetic development in preschool and primary school.",2022,"The results indicate that the students who attended the intervention, outperformed control group in the components of factual and procedural arithmetic in post-test and follow-up, however; the performance of two groups in conceptual knowledge was not different.","['children with Developmental Dyscalculia', 'students with DD', '30 male students aged 8-10 years with a formal diagnosis of Developmental Dyscalculia (DD), selected from a learning disability center in Ahvaz, Iran, participated in the study', 'children with DD']","['EF intervention', 'process-based executive function intervention', 'process-based Executive Function (EF) intervention program']",['factual and procedural arithmetic knowledge'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1395913', 'cui_str': 'Primary Dyscalculia'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751265', 'cui_str': 'Learning disability'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}]",30.0,0.0238036,"The results indicate that the students who attended the intervention, outperformed control group in the components of factual and procedural arithmetic in post-test and follow-up, however; the performance of two groups in conceptual knowledge was not different.","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Nazari', 'Affiliation': 'Faculty of Psychology and Special Education, Farhangian University, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Hakiminejad', 'Affiliation': 'Faculty of Psychology and Special Education, Farhangian University, Iran; Department of psychology and Special Education, University of Tehran, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Hassanzadeh', 'Affiliation': 'Department of psychology and Special Education, University of Tehran, Iran. Electronic address: shasanz@ut.ac.ir.'}]",Research in developmental disabilities,['10.1016/j.ridd.2022.104260']
1226,35617841,Effectiveness of pediatric nasal irrigation solution with or without xylitol.,"OBJECTIVES


/Hypothesis: The aim of this study was to compare the efficacy and outcome of daily hypertonic saline irrigation versus saline/xylitol for treating pediatric chronic rhinosinusitis (CRS).
STUDY DESIGN


This was a prospective, randomized, single-blinded study.
METHODS


One hundred and twenty-five children diagnosed with CRS were enrolled in this study. The patients were randomized to twice-daily hypertonic irrigations with saline or saline/xylitol for 6 weeks. The treatment outcomes were measured using: Sinonasal Quality of Life Survey (SN-5) completed at baseline and after 6 weeks of irrigation.
RESULTS


There were statistically significant improvements in the hypertonic nasal saline group's (reduction in SN-5 domain scores) four domains and an increase in the overall QoL score within each group after 6 weeks of treatment compared to baseline; however, there were no differences in the activity limitation (p = 0.1803). The xylitol solution groups had no differences between the two groups in the SN-5 scores in any of the domains or the overall score at baseline, and post irrigation treatment.
CONCLUSIONS


Due to low tolerance, compliance, and the side effects, xylitol irrigation is not recommended as a first-line treatment for pediatric CRS. The use of a large volume of low pressure, twice-daily intranasal hypertonic irrigation for 6 weeks is safe and effective in the treatment of pediatric CRS; therefore, it can be used as a baseline treatment for pediatric CRS before considering surgical interventions.",2022,"The xylitol solution groups had no differences between the two groups in the SN-5 scores in any of the domains or the overall score at baseline, and post irrigation treatment.
","['pediatric chronic rhinosinusitis (CRS', 'One hundred and twenty-five children diagnosed with CRS']","['daily hypertonic saline irrigation versus saline/xylitol', 'hypertonic irrigations with saline or saline/xylitol', 'pediatric nasal irrigation solution with or without xylitol', 'xylitol solution']","['SN-5 scores', 'activity limitation', 'overall QoL score', 'Sinonasal Quality of Life Survey (SN-5']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",125.0,0.154419,"The xylitol solution groups had no differences between the two groups in the SN-5 scores in any of the domains or the overall score at baseline, and post irrigation treatment.
","[{'ForeName': 'Yücel', 'Initials': 'Y', 'LastName': 'Kurt', 'Affiliation': 'KBB Uzmanı, Antalya Finike Devlet hastanesi, Turkey. Electronic address: yucelkurt00@gmail.com.'}, {'ForeName': 'Yavuz Selim', 'Initials': 'YS', 'LastName': 'Yildirim', 'Affiliation': 'Dogus University, Turkey and Hisar Intercontinental Hospital, Ümraniye, Istanbul, Turkey. Electronic address: dryavuzselim@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2022.111183']
1227,35618247,Heterogeneity of Treatment Effect in a Randomized Trial of a Communication Intervention.,"CONTEXT


Interventions to promote serious illness conversations have shown promise in promoting high-quality care. However, in randomized trials, some participants may benefit more from the intervention than others.
OBJECTIVES


To examine heterogeneity of treatment effect and identify subgroups of patients with serious illness who might benefit most from interventions to enhance communication about goals of care.
METHODS


We used data from a multi-center cluster-randomized trial evaluating a communication intervention to increase goals-of-care discussions in the outpatient setting. Patients (n = 249 intervention, n = 288 usual care) had serious illness with an expected median survival of two years. Using model-based recursive partitioning, we tested heterogeneity of the intervention's effect on the occurrence of patient-reported goals-of-care discussions, electronic health record documentation of goals-of-care discussions, patients' ratings of quality of communication, and patients' symptoms of psychological distress at three and six months.
RESULTS


We found two significant interactions. For patients' overall rating of clinician communication (n = 251), the intervention effect was positive for patients with higher household income, but not those with lower income (P < 0.001). For patients' symptoms of depression at six months (n = 288), the intervention was associated with fewer symptoms of depression among those whose self-assessed health was poor, but not among those with fair to excellent health (P < 0.001).
CONCLUSIONS


Identifying heterogeneity of treatment effect can be a valuable exercise following completion of a randomized trial. Interactions between the intervention and patient income and self-assessed health suggest these factors could be used to design more effective interventions to enhance communication about goals of care.",2022,"For patients' symptoms of depression at 6 months (n=288), the intervention was associated with fewer symptoms of depression among those whose self-assessed health was poor, but not among those with fair to excellent health (p<0.001).
","['Patients (n=249 intervention, n=288 usual care) had serious illness with an expected median survival of 2 years', 'patients with serious illness who might benefit most from interventions to enhance communication about goals of care']",['communication intervention'],['symptoms of depression'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}]","[{'cui': 'C1274143', 'cui_str': 'Communication interventions'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0193559,"For patients' symptoms of depression at 6 months (n=288), the intervention was associated with fewer symptoms of depression among those whose self-assessed health was poor, but not among those with fair to excellent health (p<0.001).
","[{'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Jennerich', 'Affiliation': 'Department of Medicine (A.L.J., L.D., R.A.E., J.R.C.), Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence (A.L.J., L.D., R.A.E., J.R.C.), University of Washington, Seattle, Washington, USA. Electronic address: along11@uw.edu.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Downey', 'Affiliation': 'Department of Medicine (A.L.J., L.D., R.A.E., J.R.C.), Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence (A.L.J., L.D., R.A.E., J.R.C.), University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Engelberg', 'Affiliation': 'Department of Medicine (A.L.J., L.D., R.A.E., J.R.C.), Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence (A.L.J., L.D., R.A.E., J.R.C.), University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Department of Medicine (A.L.J., L.D., R.A.E., J.R.C.), Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence (A.L.J., L.D., R.A.E., J.R.C.), University of Washington, Seattle, Washington, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2022.05.006']
1228,35619802,Integrated Management of Diabetes and Tuberculosis in Rural India - Results From a Pilot Study.,"Introduction


The World Health Organization and International Union against Tuberculosis (TB) recommends screening patients with TB for Diabetes Mellitus (DM) at the initiation of treatment. There are few pilot studies which screen TB patients for DM, but none of them have documented the feasibility of managing TB patients with DM in the Indian healthcare setting. Operational research is needed to determine the best way to manage individuals with both conditions. This pilot study aimed to develop, and field test an integrated, multidisciplinary program addressing the management of individuals with TB and DM and other associated chronic conditions in the Indian primary healthcare setting.
Methods


This pilot study used a randomized controlled trial design with mixed-methods evaluation and was conducted in Guntur district of Andhra Pradesh, a southern state of India. All the 120 patients newly diagnosed with TB from 10 participating villages were screened for DM and associated cardiovascular risk factors. Non-physician health workers were trained to follow-up patients for a period of 8 months to encourage treatment adherence, monitor treatment response including blood glucose levels and provide lifestyle advice.
Results


The intervention was well-accepted by the providers and patients. However, there were no statistically significant variations observed for mean blood glucose levels (mean [SD]: 5.3 [-23.3 to 33.8]) of patients for both intervention and control group participants in this feasibility study. Awareness about diabetes and tuberculosis comorbidity and cardiovascular risk increased among the non-physician health workers in the intervention arm of the study.
Discussion


The co-management of TB-DM is acceptable to both the health providers and patients. With appropriate training, availability of infrastructure and planned intervention implementation, it is feasible to co-manage TB-DM within the existing primary health care system in India.",2022,"Awareness about diabetes and tuberculosis comorbidity and cardiovascular risk increased among the non-physician health workers in the intervention arm of the study.
","['Guntur district of Andhra Pradesh, a southern state of India', 'individuals with TB and DM and other associated chronic conditions in the Indian primary healthcare setting', 'patients with TB for Diabetes Mellitus (DM', '120 patients newly diagnosed with TB from 10 participating villages', 'physician health workers', 'Diabetes and Tuberculosis in Rural India ']",[],"['Awareness about diabetes and tuberculosis comorbidity and cardiovascular risk', 'cardiovascular risk factors', 'mean blood glucose levels']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],"[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",120.0,0.0358607,"Awareness about diabetes and tuberculosis comorbidity and cardiovascular risk increased among the non-physician health workers in the intervention arm of the study.
","[{'ForeName': 'Rohina', 'Initials': 'R', 'LastName': 'Joshi', 'Affiliation': 'School of Population Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Deepanjali', 'Initials': 'D', 'LastName': 'Behera', 'Affiliation': 'KIIT School of Public Health, KIIT University, Bhubaneswar, India.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Di Tanna', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Mohammed Abdul', 'Initials': 'MA', 'LastName': 'Ameer', 'Affiliation': 'Health Systems Science, The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Yakubu', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Devarsetty', 'Initials': 'D', 'LastName': 'Praveen', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}]",Frontiers in public health,['10.3389/fpubh.2022.766847']
1229,34080017,The hen's egg test for micronucleus induction (HET-MN): validation data set.,"The classical in vitro genotoxicity test battery is known to be sensitive for indicating genotoxicity. However, a high rate of 'misleading positives' was reported when three assays were combined as required by several legislations. Despite the recent optimisations of the standard in vitro tests, two gaps could hardly be addressed with assays based on 2D monolayer cell cultures: the route of exposure and a relevant intrinsic metabolic capacity to transform pro-mutagens into reactive metabolites. Following these considerations, fertilised chicken eggs have been introduced into genotoxicity testing and were combined with a classical read-out parameter, the micronucleus frequency in circulating erythrocytes, to develop the hen's egg test for micronucleus induction (HET-MN). As a major advantage, the test mirrors the systemic availability of compounds after oral exposure by reflecting certain steps of Absorption, Distribution, Metabolism, Excretion (ADME) without being considered as an animal experiment. The assay is supposed to add to a toolbox of assays to follow up on positive findings from initial testing with classical in vitro assays. We here report on a validation exercise, in which >30 chemicals were tested double-blinded in three laboratories. The specificity and sensitivity of the HET-MN were calculated to be 98 and 84%, respectively, corresponding to an overall accuracy of 91%. A detailed protocol, which includes a picture atlas detailing the cell and micronuclei analysis, is published in parallel (Maul et al. Validation of the hen's egg test for micronucleus induction (HET-MN): detailed protocol including scoring atlas, historical control data and statistical analysis).",2022,"Validation of the hen's egg test for micronucleus induction (HET-MN): detailed protocol including scoring atlas, historical control data and statistical analysis).",[],[],"['specificity and sensitivity of the HET-MN', 'Absorption, Distribution, Metabolism, Excretion (ADME']",[],[],"[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026004', 'cui_str': 'Micronucleus'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.325659,"Validation of the hen's egg test for micronucleus induction (HET-MN): detailed protocol including scoring atlas, historical control data and statistical analysis).","[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Reisinger', 'Affiliation': 'Henkel AG & Co KGaA, Duesseldorf, Germany.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Fieblinger', 'Affiliation': 'Department of Chemical and Product Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Heppenheimer', 'Affiliation': 'ICCR-Roßdorf GmbH (formerly Harlan CCR GmbH), Rossdorf, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kreutz', 'Affiliation': 'Henkel AG & Co KGaA, Duesseldorf, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Liebsch', 'Affiliation': 'Department of Chemical and Product Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Luch', 'Affiliation': 'Department of Chemical and Product Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Maul', 'Affiliation': 'Department of Chemical and Product Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Poth', 'Affiliation': 'ICCR-Roßdorf GmbH (formerly Harlan CCR GmbH), Rossdorf, Germany.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Strauch', 'Affiliation': 'ICCR-Roßdorf GmbH (formerly Harlan CCR GmbH), Rossdorf, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dony', 'Affiliation': 'ICCR-Roßdorf GmbH (formerly Harlan CCR GmbH), Rossdorf, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schulz', 'Affiliation': 'ICCR-Roßdorf GmbH (formerly Harlan CCR GmbH), Rossdorf, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Wolf', 'Affiliation': 'University of Osnabrueck, Osnabrueck, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Pirow', 'Affiliation': 'Department of Chemical and Product Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.'}]",Mutagenesis,['10.1093/mutage/geab016']
1230,35611641,Clinical Decision Support for Newborn Weight Loss: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVE


The Newborn Weight Tool (NEWT) can inform newborn feeding decisions and might reduce health care utilization by preventing excess weight loss. Clinical decision support (CDS) displaying NEWT might facilitate its use. Our study's objective is to determine the effect of CDS displaying NEWT on feeding and health care utilization.
METHODS


At an hospital involved in NEWT development, we randomly assigned 2682 healthy infants born ≥36 weeks gestation in 2018-2019 either to CDS displaying NEWT with an electronic flag if most recent weight was ≥75th weight loss centile or to a control of usual care with NEWT accessed at clinician discretion. Our primary outcome was feeding type concordant with weight loss, defined as exclusive breastfeeding for those not flagged, exclusive breastfeeding or supplementation for those flagged once, and supplementation for those flagged more than once. Secondary outcomes included inpatient and outpatient utilization in the first 30 days. We used χ2 and Student's t tests to compare intervention infants with control and to compare trial infants with those born in 2017.
RESULTS


Feeding was concordant with for 1854 (74.5%) trial infants and did not differ between randomized groups (P = .65); concordant feeding was higher for all trial infants than for infants born in 2017 (64.4%; P < .0005). Readmission occurred for 51 (3.8%) CDS infants and 45 (3.4%) control infants (P = .56). Among the 60% of trial infants with outpatient records available, there were 3.5 ± 1.7 visits with no differences between randomized groups (P = .10).
CONCLUSIONS


At an hospital involved in NEWT development, CDS displaying NEWT did not alter either feeding or health care utilization compared with discretionary NEWT access.",2022,The Newborn Weight Tool (NEWT) can inform newborn feeding decisions and might reduce health care utilization by preventing excess weight loss.,"['Newborn Weight Loss', 'intervention infants with control and to compare trial infants with those born in 2017', '2682 healthy infants born ≥36 weeks gestation in 2018-2019 either to']","['CDS displaying NEWT', 'CDS displaying NEWT with an electronic flag if most recent weight was ≥75th weight loss centile or to a control of usual care with NEWT accessed at clinician discretion']","['feeding type concordant with weight loss, defined as exclusive breastfeeding for those not flagged, exclusive breastfeeding or supplementation', 'inpatient and outpatient utilization', 'Readmission']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C5200790', 'cui_str': 'Flags'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C5200790', 'cui_str': 'Flags'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",2682.0,0.0507067,The Newborn Weight Tool (NEWT) can inform newborn feeding decisions and might reduce health care utilization by preventing excess weight loss.,"[{'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'Flaherman', 'Affiliation': 'University of California, San Francisco, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'University of California, San Francisco, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Creasman', 'Affiliation': 'University of California, San Francisco, California.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'University of California, San Francisco, California.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Pletcher', 'Affiliation': 'University of California, San Francisco, California.'}]",Hospital pediatrics,['10.1542/hpeds.2021-006470']
1231,35613527,Is it OK to bully automated cars?,"To integrate automated vehicles (AVs) into our transportation network, we should consider how human road users will interact with them. Human aggression toward AVs could be a new risk in mixed traffic and reduce AV adoption. Is it OK to drive aggressively toward AVs? We examined how identical aggressive behavior toward an AV or human driver is appraised differently by observers. In our 2 (scenario type: human driver vs. AV) × 2 (victim identity salience: low vs. high) between-subjects survey, we randomly allocated participants (N = 956) to one of four conditions where they viewed a video clip from an AV or a human driver showing a car suddenly braking continuously ahead of the AV or human driver's car. The salience of victim identity influenced the observers' appraisals of aggressive behavior. When asked to judge the front car's behavior toward this AV or human driver (the victim identity is salient), they reported more acceptability and less risk perception, negative affect, and immoral judgment while judging this behavior toward the AV. When asked to judge the front car's behavior (the victim identity not highlighted), they reported non-different appraisals. This finding implies that AVs might need to hide their identity to blend in visually and behaviorally as regular cars.",2022,"When asked to judge the front car's behavior (the victim identity not highlighted), they reported non-different appraisals.",[],"[""video clip from an AV or a human driver showing a car suddenly braking continuously ahead of the AV or human driver's car""]",[],[],"[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0337108', 'cui_str': 'Brake'}]",[],,0.0617755,"When asked to judge the front car's behavior (the victim identity not highlighted), they reported non-different appraisals.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Center for Psychological Sciences, Zhejiang University, Hangzhou, Zhejiang, China. Electronic address: pengliu86@zju.edu.cn.'}, {'ForeName': 'Siming', 'Initials': 'S', 'LastName': 'Zhai', 'Affiliation': 'College of Management and Economics, Tianjin University, Tianjin, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'China Automotive Technology and Research Center Co., Ltd, Tianjin, China.'}]",Accident; analysis and prevention,['10.1016/j.aap.2022.106714']
1232,35613998,"Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer.","INTRODUCTION


Treatment of advanced stage non-small cell lung cancer (NSCLC) has changed dramatically due to immunotherapy. However, patients without Programmed Death-Ligand 1 (PD-L1) protein expression often benefit less from immunotherapy. This trial is designed to test if stereotactic body radiation therapy (SBRT) to a single tumor site can significantly enhance the outcome of patients with advanced stage PD-L1(-) NSCLC when added to systemic therapy including immunotherapy.
MATERIALS AND METHODS


Alliance A082002 is based on subgroup analysis from the randomized phase II PEMBRO-RT trial., PEMBRO-RT compared pembrolizumab alone or with SBRT and revealed improved progression-free and overall survival (PFS and OS, respectively) in PD-L1(-) patients when adding SBRT (8 Gy x 3 fractions). In A082002, patients without PD-L1 expression will be randomized to SBRT (8 Gy x3) plus systemic therapy vs. systemic therapy alone. The primary endpoint of the phase II portion of the trial is PFS and will require 100 patients. The primary endpoint of the phase III portion of the trial is OS and will require an additional 284 patients. This trial will clarify whether adding SBRT to systemic therapy can improve PFS and OS in a larger multi-institutional cohort. Several systemic treatment options are allowed including either immunotherapy alone or chemo-immunotherapy.
CONCLUSIONS


This phase II/III Alliance trial A082002 will test whether the addition of SBRT to a single tumor site will enhance the anti-tumor activity of systemic immunotherapy or chemo-immunotherapy in patients with stage IV PD-L1(-) NSCLC. It is now open in the National Clinical Trials Network (NCTN).",2022,", PEMBRO-RT compared pembrolizumab alone or with SBRT and revealed improved progression-free and overall survival (PFS and OS, respectively) in PD-L1(-) patients when adding SBRT (8 Gy x 3 fractions).","['for PD-L1-negative, advanced non-small cell lung cancer', 'patients with stage IV PD-L1(-) NSCLC', 'patients with advanced stage PD-L1', 'advanced stage non-small cell lung cancer (NSCLC']","['NSCLC', 'systemic therapy vs. systemic therapy alone', 'modern immunotherapy-based systemic therapy with or without SBRT', 'stereotactic body radiation therapy (SBRT', 'SBRT ', 'SBRT']","['progression-free and overall survival', 'PFS and OS']","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.23054,", PEMBRO-RT compared pembrolizumab alone or with SBRT and revealed improved progression-free and overall survival (PFS and OS, respectively) in PD-L1(-) patients when adding SBRT (8 Gy x 3 fractions).","[{'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, 13400 E. Shea Blvd, Phoenix, AZ, United States. Electronic address: sschild@mayo.edu.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Alliance Statistics and Data Management Center, Duke University, Durham, NC, United States.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Bestvina', 'Affiliation': 'Department of Hematology and Oncology, University of Chicago Medicine, Chicago, IL, United States.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': 'Department of Radiation Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Masters', 'Affiliation': 'Department of Medical Oncology, Christiana Care Hospitals, Newark, DE, United States.'}, {'ForeName': 'Anurag K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Department of Radiation Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Stinchcombe', 'Affiliation': 'Department of Medical Oncology, Duke Cancer Institute, Durham, NC, United States.'}, {'ForeName': 'Joseph K', 'Initials': 'JK', 'LastName': 'Salama', 'Affiliation': 'Department of Medical Oncology, Duke Cancer Institute, Durham, NC, United States.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'Department of Medical Oncology, Duke Cancer Institute, Durham, NC, United States.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Narjust', 'Initials': 'N', 'LastName': 'Duma', 'Affiliation': 'Department of Medical Oncology, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Chun', 'Affiliation': 'Department of Radiation Oncology, Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Amini', 'Affiliation': 'Department of Radiation Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kozono', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber/Partners Cancer Care, Boston, MA, United States.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Watt', 'Affiliation': 'Alliance Protocol Operations Central Office, University of Chicago, Chicago, IL, United States.'}]",Clinical lung cancer,['10.1016/j.cllc.2022.04.004']
1233,35613997,Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer.,"BACKGROUND


The current standard of care for patients with newly diagnosed limited-stage small-cell lung cancer (SCLC) is concurrent chemoradiotherapy (CCRT). The prognosis remains poor due to the aggressiveness and high risk of progression or relapse of SCLC even if an initial response is achieved. Therefore, there is an urgent unmet clinical need in this population. The multicenter, phase 3, randomized, placebo-controlled, double-blind KEYLYNK-013 study evaluates the addition of pembrolizumab to CCRT followed by pembrolizumab with or without olaparib in participants with previously untreated limited-stage SCLC. (ClinicalTrials.gov: NCT04624204).
METHODS


Eligible participants aged ≥18 years with newly diagnosed, pathologically confirmed, limited-stage (ie, stage I-III) SCLC will be randomized 1:1:1 to CCRT (ie, etoposide plus carboplatin or cisplatin for 4 cycles and standard thoracic radiotherapy) plus pembrolizumab (Groups A and B) or CCRT plus placebo (Group C). In the absence of disease progression, participants will receive pembrolizumab plus placebo (Group A), pembrolizumab plus olaparib (Group B), or placebo (Group C). Dual primary endpoints are progression-free survival per RECIST version 1.1 by blinded independent central review and overall survival.
RESULTS


Enrollment began in December 2020 and is ongoing at approximately 150 sites.
CONCLUSIONS


KEYLYNK-013 will provide valuable information on the efficacy and safety of pembrolizumab plus CCRT and pembrolizumab with or without olaparib post CCRT in participants with limited-stage SCLC.",2022,"Dual primary endpoints are progression-free survival per RECIST version 1.1 by blinded independent central review and overall survival.
","['participants with previously untreated limited-stage SCLC', 'Eligible participants aged ≥18 years with newly diagnosed, pathologically confirmed, limited-stage (ie, stage I-III', 'patients with newly diagnosed limited-stage small-cell lung cancer (SCLC', 'participants with limited-stage SCLC']","['CCRT (ie, etoposide plus carboplatin or cisplatin', 'Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib', 'CCRT plus placebo', 'pembrolizumab plus olaparib (Group B), or placebo', 'pembrolizumab', 'pembrolizumab to CCRT followed by pembrolizumab with or without olaparib', 'pembrolizumab plus placebo', 'chemoradiotherapy (CCRT', 'placebo']",['progression-free survival per RECIST version 1.1 by blinded independent central review and overall survival'],"[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0278725', 'cui_str': 'Small cell lung cancer limited stage'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.819104,"Dual primary endpoints are progression-free survival per RECIST version 1.1 by blinded independent central review and overall survival.
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rimner', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY. Electronic address: rimnera@mskcc.org.'}, {'ForeName': 'Wei-Chu Victoria', 'Initials': 'WV', 'LastName': 'Lai', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Califano', 'Affiliation': 'The Christie NHS Foundation Trust and The University of Manchester, Manchester, UK.'}, {'ForeName': 'Salma K', 'Initials': 'SK', 'LastName': 'Jabbour', 'Affiliation': 'Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, Robert Wood Johnson Medical School, Rutgers University, New Brunswick, NJ.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Rudin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'The Christie NHS Foundation Trust and The University of Manchester, Manchester, UK.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Jinming', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Radiation Oncology, Shandong Cancer Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Wyatt', 'Initials': 'W', 'LastName': 'Chafin', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Byers', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}]",Clinical lung cancer,['10.1016/j.cllc.2022.04.005']
1234,35616597,Modified defense reaction reduces biomechanical and myoelectrical ACL injury risk factors in elite Judo.,"In judo, an anterior cruciate ligament (ACL) injury is the most severe injury an athlete could experience. Most ACL ruptures occur when defending against an osoto-gari attack. This study aims to identify ACL risk factors during osoto-gari defence and implement a  modified osoto-gari defence reaction,  which is assumed to improve myoelectric patterns and ameliorate critical biomechanical risk factors for ACL injuries. Twenty-six elite judokas were enrolled in the cross-over trial (female: 6; male: 20). 3D kinematics and force dynamometrics were combined with electromyographical recordings to assess the effects of the  common  and the  modified osoto-gari defence reaction . Compared to the  common osoto-gari defence reaction  (maximal knee flexion: 29 ± 12°; maximal valgus: 10 ± 5°; maximal valgus moment: 58 ± 17 Nm; peak internal rotation: 9 ± 5°), the  modified osoto-gari defence reaction  showed significantly reduced knee angles (31 ± 10° p < 0.05; 1 ± 0° p < 0.05; 31 ± 9 Nm p < 0.05; 3 ± 0° p < 0.05). The myoelectric activity of the hamstring increased (+5±% to +27±%, p < 0.05) in the modified compared to common defence reaction. The  modified osoto-gari defence reaction  reduced critical biomechanical risk factors and increased hamstring myoelectric activity. We recommend the implementation of the  modified osoto-gari defence reaction  in judo practice and seek to evaluate its long-term effectiveness in decreasing ACL injury incidences in elite judo.",2022,"The myoelectric activity of the hamstring increased (+5±% to +27±%, p < 0.05) in the modified compared to common defence reaction.","['elite Judo', 'Twenty-six elite judokas were enrolled in the cross-over trial (female: 6; male: 20', 'elite judo']",[],"['knee angles (31\xa0±', 'myoelectric activity of the hamstring', 'hamstring myoelectric activity']","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}]",,0.0492657,"The myoelectric activity of the hamstring increased (+5±% to +27±%, p < 0.05) in the modified compared to common defence reaction.","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Department of Functional Diagnostics, Rennbahnklinik, Muttenz, Switzerland.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Riesterer', 'Affiliation': 'Department of Functional Diagnostics, Rennbahnklinik, Muttenz, Switzerland.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Mauch', 'Affiliation': 'Department of Functional Diagnostics, Rennbahnklinik, Muttenz, Switzerland.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Lambert', 'Affiliation': 'Department of Trauma and Orthopedic Surgery, University of Witten/Herdecke, Cologne Merheim Medical Centre, Cologne, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Department of Functional Diagnostics, Rennbahnklinik, Muttenz, Switzerland.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Ritzmann', 'Affiliation': 'Department of Functional Diagnostics, Rennbahnklinik, Muttenz, Switzerland.'}]",Journal of sports sciences,['10.1080/02640414.2022.2080160']
1235,35618168,Cortical excitatory and inhibitory correlates of the fronto-limbic circuit in major depression and differential effects of left frontal brain stimulation in a randomized sham-controlled trial.,"BACKGROUND


Major depressive disorder (MDD), particularly treatment-resistant ones, is associated with abnormal fronto-limbic glucose metabolism. 10-Hz repetitive transcranial magnetic stimulation (rTMS) over left prefrontal cortex (PFC) is believed to normalize the abnormal metabolism to treat depression. However, the exact molecular mechanisms underlying the mood circuit of depressed brains and whether brain stimulation techniques regulate the underlying molecules remain elusive.
METHODS


Whole-brain glucose metabolism and cortical excitatory and inhibitory markers including P30, N45, P60, N100, and LICI (long-interval cortical inhibition) of TMS-evoked potentials from left DLPFC were measured in 40 subjects with MDD patients. The neurophysiological markers were repeated immediately after 1st session of left PFC rTMS, intermittent theta-burst stimulation (iTBS), and sham (randomly assigned).
RESULTS


Brain glucose metabolism in the limbic structures significantly correlated with left PFC P30 (mainly GABA-A and glutamate receptor mediated) and with LICI (mainly GABA-B receptor mediated inhibition) (FWE-corrected p < 0.001). Correlations between other neurophysiological markers (left PFC N45, P60, and N100) and posterior cingulate cortex, a key region in the default mode network, were also noted. One session of rTMS significantly decreased left PFC P60 (mainly glutamate receptor mediated), while a significant group effect was found for LICI (iTBS < sham).
CONCLUSION


The first study showed that the underlying molecular mechanisms of fronto-limbic circuit of MDD brains involved glutamatergic excitation and GABAergic inhibition at specific time points. In addition, one session of rTMS mainly modulated glutamatergic neurotransmission at left PFC, while the mechanisms of iTBS might involve GABA-B receptor mediated inhibition.
CLINICAL TRIALS REGISTRY NUMBER


UMIN000044951.",2022,"One session of rTMS significantly decreased left PFC P60 (mainly glutamate receptor mediated), while a significant group effect was found for LICI (iTBS < sham).
",['40 subjects with MDD patients'],"['rTMS', '10-Hz repetitive transcranial magnetic stimulation (rTMS']","['P30, N45, P60, N100, and LICI (long-interval cortical inhibition) of TMS-evoked potentials from left DLPFC', 'left PFC P30', 'left PFC P60']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0069919', 'cui_str': 'ranpirnase'}, {'cui': 'C1137054', 'cui_str': 'SQSTM1 protein, human'}, {'cui': 'C0444779', 'cui_str': 'N100 (N1)'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",40.0,0.0715168,"One session of rTMS significantly decreased left PFC P60 (mainly glutamate receptor mediated), while a significant group effect was found for LICI (iTBS < sham).
","[{'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan; Institute of Brain Science and Brain Research Center, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan; Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan. Electronic address: ctil2@vghtpe.gov.tw.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Juan', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan.'}, {'ForeName': 'Hui-Ching', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Department and Institute of Physiology, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Wu', 'Affiliation': 'Institute of Brain Science and Brain Research Center, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan.'}, {'ForeName': 'Bang-Hung', 'Initials': 'BH', 'LastName': 'Yang', 'Affiliation': 'Department of Nuclear Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan; Institute of Brain Science and Brain Research Center, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan; Institute of Brain Science and Brain Research Center, School of Medicine, National Yang-Ming Chiao-Tung University, Taipei, Taiwan.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth HealthCare and Department of Psychiatry, Monash University, Camberwell, Victoria, Australia. Electronic address: paul.fitzgerald@monash.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2022.05.107']
1236,35618101,Prognostic factors for survival and ambulatory status at 8 weeks with metastatic spinal cord compression in the SCORAD randomised trial.,"BACKGROUND


Metastatic spinal cord compression (MSCC) carries a poor prognosis and management is based on the likelihood of maintaining mobility and predicted survival.
PATIENTS AND METHOD


SCORAD is a randomised trial of 686 patients comparing a single dose of 8 Gy radiotherapy with 20 Gy in 5 fractions. Data was split into a training set (412, 60%) and a validation set (274, 40%). A multivariable Cox regression for overall survival (OS) and a logistic regression for ambulatory status at 8 weeks were performed in the training set using baseline factors and a backward selection regression to identify a parsimonious model with p ≤ 0.10. Receiver Operating Characteristic (ROC) analysis evaluated model prognostic performance in the validation set. Validation of the final survival model was performed in a separate registry dataset (n = 348).
RESULTS


The survival Cox model identified male gender, lung, gastrointestinal, and other types of cancer, compression at C1-T12, presence of non-skeletal metastases and poor ambulatory status all significantly associated with worse OS (all p < 0.05). The ROC AUC for the selected model was 75% (95%CI: 69-81) in the SCORAD validation set and 68% (95%CI: 62-74) in the external validation registry data. The logistic model for ambulatory outcome identified primary tumour breast or prostate, ambulatory status grade 1 or 2, bladder function normal and prior chemotherapy all significantly associated with increased odds of ambulation at 8 weeks (all p < 0.05). The ROC AUC for the selected model was 72.3% (95% CI 62.6-82.0) in the validation set.
CONCLUSIONS


Primary breast or prostate cancer, and good ambulatory status at presentation, are favourable prognostic factors for both survival and ambulation after treatment.",2022,"The ROC AUC for the selected model was 72.3% (95% CI 62.6-82.0) in the validation set.
",['686 patients comparing a single dose of 8Gy radiotherapy with 20Gy in 5 fractions'],[],"['primary tumour breast or prostate, ambulatory status grade 1 or 2, bladder function normal and prior chemotherapy', 'overall survival (OS', 'Receiver Operating Characteristic (ROC) analysis evaluated model prognostic performance']","[{'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0232840', 'cui_str': 'Bladder function'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",686.0,0.123489,"The ROC AUC for the selected model was 72.3% (95% CI 62.6-82.0) in the validation set.
","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hoskin', 'Affiliation': 'Mount Vernon Cancer Centre Northwood and University of Manchester, United Kingdom. Electronic address: peterhoskin@nhs.net.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Hopkins', 'Affiliation': 'Bristol Centre for Haematology and Oncology, Bristol, United Kingdom.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Misra', 'Affiliation': 'The Christie Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Holt', 'Affiliation': 'Princess Alexandra Hospital, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Rhona', 'Initials': 'R', 'LastName': 'McMenemin', 'Affiliation': 'The Freeman Hospital Newcastle, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McKinna', 'Affiliation': 'Royal Sussex County Hospital, Brighton, United Kingdom.'}, {'ForeName': 'Krishnaswamy', 'Initials': 'K', 'LastName': 'Madhavan', 'Affiliation': 'Southend University Hospital, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Southampton General Hospital, United Kingdom.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': ""O'Rourke"", 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Lester', 'Affiliation': 'Velindre Cancer Centre, Cardiff, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Sevitt', 'Affiliation': 'Kent Oncology Centre, Maidstone, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Roos', 'Affiliation': 'Royal Adelaide Hospital and University of Adelaide, Australia.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': 'Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Sharon Shibu', 'Initials': 'SS', 'LastName': 'Thomas', 'Affiliation': 'Southend University Hospital, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Forsyth', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Reczko', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""O'Hara"", 'Affiliation': 'The Christie Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2022.05.017']
1237,35619144,Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis-the VACOR trial: protocol for a randomised controlled trial.,"BACKGROUND


Secondary peritonitis is a severe condition with a 20-32% reported mortality. The accepted treatment modalities are vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD). However, no randomised controlled trial has been completed to compare the two methods potential benefits and disadvantages.
METHODS


This study will be a randomised controlled multicentre trial, including patients aged 18 years or older with purulent or faecal peritonitis confined to at least two of the four abdominal quadrants originating from the small intestine, colon, or rectum. Randomisation will be web-based to either primary closure with ROD or VAC in blocks of 2, 4, and 6. The primary endpoint is peritonitis-related complications within 30 or 90 days and one year after index operation. Secondary outcomes are comprehensive complication index (CCI) and mortality after 30 or 90 days and one year; quality of life assessment by (SF-36) after three and 12 months, the development of incisional hernia after 12 months assessed by clinical examination and CT-scanning and healthcare resource utilisation. With an estimated superiority of 15% in the primary outcome for VAC, 340 patients must be included. Hospitals in Denmark and Europe will be invited to participate.
DISCUSSION


There is no robust evidence for choosing either open abdomen with VAC treatment or primary closure with relaparotomy on-demand in patients with secondary peritonitis. The present study has the potential to answer this important clinical question.
TRIAL REGISTRATION


The study protocol has been registered at clinicaltrials.gov (NCT03932461). Protocol version 1.0, 9 January 2022.",2022,There is no robust evidence for choosing either open abdomen with VAC treatment or primary closure with relaparotomy on-demand in patients with secondary peritonitis.,"['patients with secondary peritonitis', 'Hospitals in Denmark and Europe', 'patients aged 18\xa0years or older with purulent or faecal peritonitis confined to at least two of the four abdominal quadrants originating from the small intestine, colon, or rectum', 'patients with secondary peritonitis-the VACOR trial', '340 patients must be included']","['Vacuum-assisted closure versus on-demand relaparotomy', 'vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD']","['peritonitis-related complications within 30 or 90\xa0days and one year after index operation', 'comprehensive complication index (CCI) and mortality after 30 or 90\xa0days and one year; quality of life assessment by (SF-36', 'clinical examination and CT-scanning and healthcare resource utilisation', 'development of incisional hernia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439665', 'cui_str': 'Purulent'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0077971', 'cui_str': 'Vacor'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1956080', 'cui_str': 'Vacuum-Assisted Closure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}]",340.0,0.389696,There is no robust evidence for choosing either open abdomen with VAC treatment or primary closure with relaparotomy on-demand in patients with secondary peritonitis.,"[{'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Rajabaleyan', 'Affiliation': 'Research Unit for Surgery, Odense University Hospital, Odense, Denmark. Pooya.rajabaleyan@rsyd.dk.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Michelsen', 'Affiliation': 'Research Unit for Anaesthesiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Uffe', 'Initials': 'U', 'LastName': 'Tange Holst', 'Affiliation': 'Research Unit for Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'OPEN, Open Patient Data Explorative Network, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Research Unit for Anaesthesiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Luxhøi', 'Affiliation': 'Surgical Department, Hospital of Southwest Jutland, Esbjerg, Denmark.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Buyukuslu', 'Affiliation': 'Surgical Department, Hospital of Southwest Jutland, Esbjerg, Denmark.'}, {'ForeName': 'Aske Mathias', 'Initials': 'AM', 'LastName': 'Bohm', 'Affiliation': 'Surgical Department, Holbæk Hospital, Holbæk, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Borly', 'Affiliation': 'Surgical Department, Holbæk Hospital, Holbæk, Denmark.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Sandblom', 'Affiliation': 'Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kobborg', 'Affiliation': 'Surgical Department, Kolding Hospital, Kolding, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Aagaard Poulsen', 'Affiliation': 'Research Unit for Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Uffe', 'Initials': 'U', 'LastName': 'Schou Løve', 'Affiliation': 'Surgical Department, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Ovesen', 'Affiliation': 'Surgical Department, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Grant Sølling', 'Affiliation': 'Surgical Department, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Mørch Søndergaard', 'Affiliation': 'Surgical Department, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lund Lomholt', 'Affiliation': 'Surgical Department, Aarhus University Hospital, Århus, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Ritz Møller', 'Affiliation': 'Surgical Department, Aarhus University Hospital, Århus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Qvist', 'Affiliation': 'Research Unit for Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bremholm Ellebæk', 'Affiliation': 'Research Unit for Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",World journal of emergency surgery : WJES,['10.1186/s13017-022-00427-x']
1238,35623596,Factors associated with self-reported sun exposure in a multi-ethnic community sample from New Zealand.,"Sun exposure, the main source of vitamin D, may have beneficial effects in humans, including for cardiovascular health. However, little is known about the characteristics related to sun exposure. Previous studies have surveyed participants with a demographic profile that is restricted by sex and ethnicity. We carried out an analysis to identify factors associated with self-reported sun exposure in a large multi-ethnic study of men and women. The study was a cross-sectional analysis of baseline data collected in a large vitamin D supplementation randomized controlled trial. The weekly amount of sun exposure in the past three months was assessed using a questionnaire. Multivariable prevalence ratios (PR) of high sun exposure (≥ 15 h/ week) associated with demographic and lifestyle variables were calculated using Poisson regression to adjust for covariates. A P-value of < 0.05 (2-tail) was used to determine statistical significance. A total of 5039 participants aged 50-84 years were analysed, who comprised 330 Pacific Islanders, 267 Māori, 242 South Asian and 4200 Other ethnicities (mostly European ancestry). For demographic variables, high sun exposure was associated with sex (higher in males), ethnicity (highest in Māori, lowest in South Asian), and education (highest in those completing secondary level education), but was lowest in the oldest age-group (80-84 years). For lifestyle variables, high sun exposure was associated with higher levels of alcohol drinking, TV watching and physical activity, but was not associated with tobacco smoking. Weekly sun exposure was lower in participants who were overweight or obese (compared to those with normal body mass index), and in those who reported a skin reaction to sun exposure of burning only (compared to those who reported tanning). These associations remained when all variables were included in the same model. In conclusion, several demographic and lifestyle factors were associated independently with the sun exposure, the primary source of vitamin D. Understanding how these factors are associated with sun exposure may refine strategies to minimise vitamin D deficiency.",2022,"Weekly sun exposure was lower in participants who were overweight or obese (compared to those with normal body mass index), and in those who reported a skin reaction to sun exposure of burning only (compared to those who reported tanning).","['participants who were overweight or obese (compared to those with normal body mass index), and in those who reported a skin reaction to sun exposure of burning only (compared to those who reported tanning', '5,039 participants aged 50 to 84 years were analysed, who comprised 330 Pacific Islanders, 267 Māori, 242 South Asian and 4,200 Other ethnicities (mostly European ancestry', 'men and women']",[],"['alcohol drinking, TV watching and physical activity', 'Multivariable prevalence ratios (PR) of high sun exposure (≥ 15hours/ week) associated with demographic and lifestyle variables']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0231253', 'cui_str': 'Normal body mass index'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0039295', 'cui_str': 'Tanning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0242191', 'cui_str': 'Pacific Island Americans'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",5039.0,0.0754796,"Weekly sun exposure was lower in participants who were overweight or obese (compared to those with normal body mass index), and in those who reported a skin reaction to sun exposure of burning only (compared to those who reported tanning).","[{'ForeName': 'Juma', 'Initials': 'J', 'LastName': 'Rahman', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2022.106131']
1239,35627597,"Effects of  Tetraselmis chuii  Microalgae Supplementation on Anthropometric, Hormonal and Hematological Parameters in Healthy Young Men: A Double-Blind Study.","The aim of this study was to evaluate the effects of  Tetraselmis chuii  (TC) microalgae supplementation for sixty days on hematological, anthropometric and hormonal parameters in healthy young men. Forty-six men divided into a placebo group (PG;  n  = 16; 20.77 ± 2.7 years; 72.14 ± 7.18 kg; 1.76 ± 0.07 m), a group supplemented with 25 mg/day of TC (SG 25;  n  = 15; 20.40 ± 1.40 years; 71.28 ± 8.26 kg; 1.76 ± 0.05 m) and another group supplemented with 200 mg/day of TC (SG 200;  n  = 15; 20.83 ± 2.45 years; 72.30 ± 11.13 kg; 1.77 ± 0.08 m) participated in this double-blind study. PG ingested 200 mg/day of lactose powder. Participants underwent 4 assessments (baseline, month 1, month 2 and desadaptation) separated in time by an interval of thirty days. At SG 25 and SG 200, significant increases in percent muscle mass, erythropoietin, insulin-like growth factor 1, free testosterone, leukocytes, neutrophils and lymphocytes were observed ( p  &lt; 0.05). Decreases in the levels of percent fat mass, platelets, hematocrit and mean corpuscular hemoglobin also occurred in these groups ( p  &lt; 0.05). TC supplementation induced favorable changes on anthropometric, hematological and hormonal levels. In view of the data, it seems that the most effective dose was 25 mg/day of TC.",2022,"At SG 25 and SG 200, significant increases in percent muscle mass, erythropoietin, insulin-like growth factor 1, free testosterone, leukocytes, neutrophils and lymphocytes were observed ( p  &lt; 0.05).","['Forty-six men divided into a', 'Healthy Young Men', 'healthy young men']","['Tetraselmis chuii  Microalgae Supplementation', 'lactose powder', 'Tetraselmis chuii  (TC) microalgae supplementation', 'TC supplementation', 'placebo']","['hematological, anthropometric and hormonal parameters', 'percent muscle mass, erythropoietin, insulin-like growth factor 1, free testosterone, leukocytes, neutrophils and lymphocytes', 'levels of percent fat mass, platelets, hematocrit and mean corpuscular hemoglobin', 'Anthropometric, Hormonal and Hematological Parameters', 'anthropometric, hematological and hormonal levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C2936330', 'cui_str': 'Microphytes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0369183', 'cui_str': 'Mean corpuscular hemoglobin determination'}]",,0.0905547,"At SG 25 and SG 200, significant increases in percent muscle mass, erythropoietin, insulin-like growth factor 1, free testosterone, leukocytes, neutrophils and lymphocytes were observed ( p  &lt; 0.05).","[{'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García', 'Affiliation': 'School of Sport Sciences, University of Extremadura, Avenida de la Universidad s/n, 10003 Cáceres, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'School of Sport Sciences, University of Extremadura, Avenida de la Universidad s/n, 10003 Cáceres, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'SER Research Group, Center of Higher Education Alberta Giménez (Affiliated to Comillas Pontifical University), 07011 Palma de Mallorca, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'School of Sport Sciences, University of Extremadura, Avenida de la Universidad s/n, 10003 Cáceres, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'School of Sport Sciences, University of Extremadura, Avenida de la Universidad s/n, 10003 Cáceres, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'School of Sport Sciences, University of Extremadura, Avenida de la Universidad s/n, 10003 Cáceres, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19106060']
1240,35627588,Efficacy of Combining an Extraoral High-Volume Evacuator with Preprocedural Mouth Rinsing in Reducing Aerosol Contamination Produced by Ultrasonic Scaling.,"The coronavirus disease pandemic has afforded dental professionals an opportunity to reconsider infection control during treatment. We investigated the efficacy of combining extraoral high-volume evacuators (eHVEs) with preprocedural mouth rinsing in reducing aerosol contamination by ultrasonic scalers. A double-masked, two-group, crossover randomized clinical trial was conducted over eight weeks. A total of 10 healthy subjects were divided into two groups; they received 0.5% povidone-iodine (PI), essential oil (EO), or water as preprocedural rinse. Aerosols produced during ultrasonic scaling were collected from the chest area (PC), dentist's mask, dentist's chest area (DC), bracket table, and assistant's area. Bacterial contamination was assessed using colony counting and adenosine triphosphate assays. With the eHVE 10 cm away from the mouth, bacterial contamination by aerosols was negligible. With the eHVE 20 cm away, more dental aerosols containing bacteria were detected at the DC and PC. Mouth rinsing decreased viable bacterial count by 31-38% (PI) and 22-33% (EO), compared with no rinsing. The eHVE prevents bacterial contamination when close to the patient's mouth. Preprocedural mouth rinsing can reduce bacterial contamination where the eHVE is positioned away from the mouth, depending on the procedure. Combining an eHVE with preprocedural mouth rinsing can reduce bacterial contamination in dental offices.",2022,"Mouth rinsing decreased viable bacterial count by 31-38% (PI) and 22-33% (EO), compared with no rinsing.","['dental offices', '10 healthy subjects']","['povidone-iodine (PI), essential oil (EO), or water as preprocedural rinse', 'extraoral high-volume evacuators (eHVEs) with preprocedural mouth rinsing']","['viable bacterial count', 'Bacterial contamination', 'dental aerosols containing bacteria']","[{'cui': 'C0011386', 'cui_str': 'Dental Office'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0442089', 'cui_str': 'Extraoral approach'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",10.0,0.0404466,"Mouth rinsing decreased viable bacterial count by 31-38% (PI) and 22-33% (EO), compared with no rinsing.","[{'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Takenaka', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Sotozono', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}, {'ForeName': 'Asaka', 'Initials': 'A', 'LastName': 'Yashiro', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}, {'ForeName': 'Niraya', 'Initials': 'N', 'LastName': 'Kornsombut', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}, {'ForeName': 'Traithawit', 'Initials': 'T', 'LastName': 'Naksagoon', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Nagata', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Ida', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Edanami', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Noiri', 'Affiliation': 'Division of Cariology, Operative Dentistry and Endodontics, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University, Niigata 951-8514, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph19106048']
1241,35627562,"The Effects of Meditation with Stabilization Exercise in Marine Region on Pain, Tactile Sense, Muscle Characteristics and Strength, Balance, Quality of Life, and Depression in Female Family Caregivers of People with Severe Physical Disabilities: A Randomized Single-Blinded Controlled Pilot Study.","Female caregivers of people with disabilities are burdened physically and mentally. To improve these symptoms, an intervention that is easy to apply and has fewer side effects, such as natural healing, has been proposed, but the effect of healing using marine resources is unclear until now. The purpose of this study is to investigate the effect of meditation accompanied with stabilization exercise in the marine region on the improvement of pain, tactile sense, muscle characteristics, muscle strength, balance, quality of life, and depression in female caregivers of people with severe physical disabilities. Twenty-four female family caregivers were recruited and were randomly assigned to the marine therapy group (MTG,  n  = 12) and the control group (CG,  n  = 12). Both groups performed the same meditation (35 min) and stabilization exercise (25 min) twice a day for 3 nights and 4 days per session (total 8 sessions). The MTG performed these in the marine region, whereas the CG performed the interventions in the urban region. Pain (pain intensity and pain pressure threshold), tactile sense (tactile spatial acuity), muscle characteristics (stiffness, elasticity), muscle strength (hand and pinch grip strength), balance, quality of life, and depression were measured before and after the intervention and 4 weeks after the intervention. Both groups showed significant improvements in pain intensity (resting pain: f(2) = 72.719,  p  &lt; 0.001; movement pain: f(2) = 24.952,  p  &lt; 0.001), muscle strength (right pinch grip: f(2) = 15.265,  p  &lt; 0.001), and depression (f(2) = 13.312,  p  &lt; 0.001), while tactile spatial acuity (TSA) (upper part: f(2) = 14.460,  p  &lt; 0.001; lower part: f(2) = 7.672,  p  = 0.002), dynamic balance (f(2) = 4.196,  p  = 0.024), and quality of life (overall quality of life & general health: f(2) = 5.443,  p  = 0.009; physical health: f(2) = 13.991,  p  &lt; 0.001; psychological: f(2) = 9.946,  p  &lt; 0.001; environmental: f(2) = 20.004,  p  &lt; 0.001; total: f(2) = 11.958,  p  &lt; 0.001) were significantly improved only in MTG. There was no significant change in pain pressure threshold (upper trapezius (UT): f(2) = 0.765,  p  = 0.473; levator scapula (LS): f(2) = 0.213,  p  = 0.809; splenius capitis (SC): f(2) = 0.186,  p  = 0.831) and muscle characteristics (UT stiffness: f(2) = 1.486,  p  = 0.241; UT elasticity: f(2) = 0.358,  p  = 0.702; LS stiffness: f(2) = 2.440,  p  = 0.102; LS elasticity: f(2) = 0.544,  p  = 0.585) in both groups. In comparison between groups, the MTG showed a significant difference in sensory function compared to the CG (resting pain: f(2) = 10.487,  p  = 0.005; lower part: f(2) = 5.341,  p  = 0.034 in TSA). Our findings suggest that meditation combined with stabilization exercise improved pain, muscle strength, and depression of female caregivers. In particular, greater benefits on tactile sense, balance, and quality of life were found in performing these in the marine region compared to the urban region.",2022,"There was no significant change in pain pressure threshold (upper trapezius (UT): f(2) = 0.765,  ","['Twenty-four female family caregivers', 'Female Family Caregivers of People with Severe Physical Disabilities', 'Female caregivers of people with disabilities are burdened physically and mentally', 'female caregivers of people with severe physical disabilities']","['meditation combined with stabilization exercise', 'meditation accompanied with stabilization exercise', 'Meditation with Stabilization Exercise', 'same meditation (35 min) and stabilization exercise', 'marine therapy group (MTG']","['muscle strength', 'Pain, Tactile Sense, Muscle Characteristics and Strength, Balance, Quality of Life, and Depression', 'pain intensity', 'tactile spatial acuity (TSA', 'quality of life (overall quality of life & general health: f(2', 'pain pressure', 'pain, tactile sense, muscle characteristics, muscle strength, balance, quality of life, and depression', 'sensory function', 'pain, muscle strength, and depression of female caregivers', 'dynamic balance (f(2) ', 'Pain (pain intensity and pain pressure threshold), tactile sense (tactile spatial acuity), muscle characteristics (stiffness, elasticity), muscle strength (hand and pinch grip strength), balance, quality of life, and depression', 'tactile sense, balance, and quality of life']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0702221', 'cui_str': 'Touch sensation, function'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C1266025', 'cui_str': 'Traditional serrated adenoma'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0427081', 'cui_str': 'Pinch grip'}]",24.0,0.0228525,"There was no significant change in pain pressure threshold (upper trapezius (UT): f(2) = 0.765,  ","[{'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Sung-Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Jae-Hon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Schulich School of Medicine and Dentistry, Western University, London, ON N6A 5W9, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph19106025']
1242,35627554,Physiotherapy Programmes Aided by VR Solutions Applied to the Seniors Affected by Functional Capacity Impairment: Randomised Controlled Trial.,"Modern technologies are presently harnessed in response to a complex challenge of providing physiotherapeutic management in older adults. Fully immersive virtual reality (VR) solutions are acknowledged to viably enhance the overall effectiveness of traditional physiotherapeutic methods. A total of 60 community-dwelling older adults (over 75 years of age) were recruited for the study protocol. They were subsequently randomly split into four equally sized study groups (VR, CVR, OCULUS, and the classic programme group (OTAGO), and the physiotherapy sessions were pursued in the subjects' homes for 3 weeks, 3 times a week, for 30 min in each group. At the first measurement point, respective study groups differed significantly in functional performance, as expressed in gait (POMA G) and individual static balance. The post hoc analysis indicated significantly higher scores in POMA G for the classic programme group vs. the results of the VR and CVR groups. On the other hand, the OCULUS group held significantly higher scores in individual balance and TUG, as compared to the other groups ( p  &lt; 0.001). Making use of a virtual reality (VR) environment in the physiotherapeutic management of community-dwelling older adults appreciably enhanced individual functional performance, especially in terms of static balance. Physiotherapy management aided by VR technology solutions offers a viable alternative to traditional physiotherapeutic regimens (e.g., OTAGO programme) in enhancing individual functional performance. The innovatively self-designed VIRTUAL REALITY COMPREHENSIVE REHABILITATION ROOMS (VRCRR) solution may help out in pursuing a complex physiotherapy programme on an individual basis within one's own home environment.",2022,The post hoc analysis indicated significantly higher scores in POMA G for the classic programme group vs. the results of the VR and CVR groups.,"['60 community-dwelling older adults (over 75 years of age', 'older adults', 'community-dwelling older adults', 'Seniors']","['virtual reality (VR) environment', 'Fully immersive virtual reality (VR) solutions', 'Physiotherapy management aided by VR technology solutions']","['individual balance and TUG', 'functional performance, as expressed in gait (POMA G) and individual static balance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}, {'cui': 'C0441463', 'cui_str': 'Static'}]",60.0,0.00959848,The post hoc analysis indicated significantly higher scores in POMA G for the classic programme group vs. the results of the VR and CVR groups.,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Zak', 'Affiliation': 'Jan Kochanowski University, Institute of Health Sciences, Collegium Medicum, Zeromskiego 5, 25-369 Kielce, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Sikorski', 'Affiliation': 'Jan Kochanowski University, Doctoral School, Zeromskiego 5, 25-369 Kielce, Poland.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Krupnik', 'Affiliation': 'Symmetry, Medical Rehabilitation Centre, 41-208 Sosnowiec, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Wasik', 'Affiliation': 'Jan Kochanowski University, Doctoral School, Zeromskiego 5, 25-369 Kielce, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Grzanka', 'Affiliation': 'Jan Kochanowski University, Doctoral School, Zeromskiego 5, 25-369 Kielce, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Courteix', 'Affiliation': 'Université Clermont Auvergne, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'CHU Clermont-Ferrand, Occupational and Environmental Medicine, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Brola', 'Affiliation': 'Jan Kochanowski University, Institute of Health Sciences, Collegium Medicum, Zeromskiego 5, 25-369 Kielce, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph19106018']
1243,35627681,Impact of High-Intensity Interval Training on Body Composition and Depressive Symptoms in Adults under Home Confinement.,"The home confinement derived from the COVID-19 pandemic has led to drastic changes in people's habits. This situation has influenced their eating, rest, physical activity and socialization patterns, triggering changes in their mental stability. It was demonstrated that physical activity is beneficial for people's physical and mental health. By its moderate volume and requiring little space or material, high-intensity interval training (HIIT) could prove to be a valid alternative in a situation of confinement. The aim of the present study was to observe the impact of an 8-week HIIT protocol on the body composition and the depressive symptoms of adults in strict home confinement. A total of 21 healthy adults, both male and female, (35.4 ± 5.6 years old; 70.50 ± 12.1 kg; 171 ± 10 cm) were divided into an experimental group (EG, n = 11) who carried out an 8-week Tabata protocol, based upon calisthenic exercises with their own weight in their homes, and a control group (CG, n = 10) who did not carry out any systematic physical activity over the same period. Following the intervention, the EG experienced a significant reduction in percentage (t = 3.86, d = 0.57,  p  &lt; 0.05) and in kg (t = 4.62, d = 0.29,  p  &lt; 0.05) of body fat mass (BFM) and body fat mass index (BFMI) (t = 4.61, d = 0.31,  p  &lt; 0.05), as well as a reduction in depressive symptoms (t = 6.48, d = 1.3,  p  &lt; 0.05). These results indicate that HIIT is a potential public health tool that could possibly be prescribed to the population in case of future situations of home confinement.",2022,"Following the intervention, the EG experienced a significant reduction in percentage (t = 3.86, d = 0.57,  p  &lt; 0.05) and in kg (t = 4.62, d = 0.29,  p  &lt; 0.05) of body fat mass (BFM) and body fat mass index (BFMI)","['Adults under Home Confinement', 'adults in strict home confinement', '21 healthy adults, both male and female, (35.4 ± 5.6 years old; 70.50 ± 12.1 kg; 171 ± 10 cm']","['HIIT protocol', 'High-Intensity Interval Training', 'calisthenic exercises with their own weight in their homes, and a control group (CG, n = 10) who did not carry out any systematic physical activity']","['Body Composition and Depressive Symptoms', 'depressive symptoms', 'body fat mass (BFM) and body fat mass index (BFMI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0006759', 'cui_str': 'Calisthenics'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0565685', 'cui_str': 'Does not carry'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",21.0,0.00777817,"Following the intervention, the EG experienced a significant reduction in percentage (t = 3.86, d = 0.57,  p  &lt; 0.05) and in kg (t = 4.62, d = 0.29,  p  &lt; 0.05) of body fat mass (BFM) and body fat mass index (BFMI)","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Alonso-Fernández', 'Affiliation': 'Departament of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Fernández-Rodríguez', 'Affiliation': 'Departament of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Yaiza', 'Initials': 'Y', 'LastName': 'Taboada-Iglesias', 'Affiliation': 'Departament of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Águeda', 'Initials': 'Á', 'LastName': 'Gutiérrez-Sánchez', 'Affiliation': 'Departament of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19106145']
1244,35627657,Effect of Diet and Exercise-Induced Weight Loss among Metabolically Healthy and Metabolically Unhealthy Obese Children and Adolescents.,"OBJECTIVE


To study the effect of diet- and exercise-based lifestyle intervention on weight loss (WL) and cardiovascular risk among metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) children and adolescents.
METHODS


The sample included 282 obese individuals (54% males, age (±SD) 12.9 (±2.3) years) who completed a 3- to 4-week WL camp program between 2017 and 2019. MUO was defined according to the consensus-based definition of pediatric MHO in 2018.
RESULTS


The intervention exhibited significantly benefits in improving body weight, body mass index, body fat ratio, waist circumference, systolic blood pressure (SBP), diastolic blood pressure (DBP), resting heart rate (RHR), triglycerides (TG), total cholesterol, and low-density lipoprotein-cholesterol levels in both MHO and MUO groups (for all comparisons,  p  &lt; 0.01). However, the beneficial high-density lipoprotein-cholesterol (HDL-C) level (both  p  &lt; 0.01) decreased evidently in both groups after intervention. In addition, percent changes in SBP ( p  &lt; 0.001), DBP ( p  &lt; 0.001), RHR ( p  = 0.025), fasting blood glucose ( p  = 0.011), and TG ( p  &lt; 0.001) were more profound in MUO group than that in MHO group.
CONCLUSION


Metabolical health is a mutable and transient state during childhood. Although both groups gained comparable WL benefits from diet- and exercise-based lifestyle intervention, the MUO group may benefit more than the MHO group. Strategies aiming at lowering blood pressure and preventing the decrease of HDL-C level should be considered for the precise treatment of childhood obesity in clinical practice, with the goal of improving metabolically healthy state.",2022,"In addition, percent changes in SBP ( p  &lt; 0.001), DBP ( p  &lt; 0.001), RHR ( p  = 0.025), fasting blood glucose ( p  = 0.011), and TG ( p  &lt; 0.001) were more profound in MUO group than that in MHO group.
","['282 obese individuals (54% males, age (±SD) 12.9 (±2.3) years) who completed a 3- to 4-week WL camp program between 2017 and 2019', 'Metabolically Healthy and Metabolically Unhealthy Obese Children and Adolescents', 'metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) children and adolescents']","['diet- and exercise-based lifestyle intervention', 'Diet and Exercise-Induced Weight Loss']","['RHR', 'weight loss (WL) and cardiovascular risk', 'SBP', 'beneficial high-density lipoprotein-cholesterol (HDL-C) level', 'DBP', 'fasting blood glucose', 'body weight, body mass index, body fat ratio, waist circumference, systolic blood pressure (SBP), diastolic blood pressure (DBP), resting heart rate (RHR), triglycerides (TG), total cholesterol, and low-density lipoprotein-cholesterol levels', 'MUO']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}]",282.0,0.00801708,"In addition, percent changes in SBP ( p  &lt; 0.001), DBP ( p  &lt; 0.001), RHR ( p  = 0.025), fasting blood glucose ( p  = 0.011), and TG ( p  &lt; 0.001) were more profound in MUO group than that in MHO group.
","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'International College of Football, Tongji University, Shanghai 200092, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Shanghai Dianfeng Sports Management Co., Ltd., Shanghai 200441, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'International College of Football, Tongji University, Shanghai 200092, China.'}, {'ForeName': 'Linyu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'International College of Football, Tongji University, Shanghai 200092, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Sports and Health Research Center, Department of Physical Education, Tongji University, Shanghai 200092, China.'}]",International journal of environmental research and public health,['10.3390/ijerph19106120']
1245,35627652,Effects of the Heart to Heart Card Game for Patients with Advanced Cancer Receiving Home-Based Palliative Care: A Clinical Randomized Controlled Trial.,"The Heart to Heart Card Game improves psychological health outcomes in hospitalized patients with advanced cancer, but effectiveness studies for patients at home are rare. This randomized controlled study was conducted to determine the effectiveness of the Heart to Heart Card Game on patients with advanced cancer receiving home-based palliative care. Sixty-six participants were randomly assigned to the intervention group ( n  = 34) and control group ( n  = 32). The quality of life, dignity, and psychological distress were considered as outcomes, which were assessed pre-intervention and six weeks after the intervention. There was a statistical difference in the quality of life (global health statues) between the intervention group and the control group after intervention ( z  = 2.017,  p  &lt; 0.05). A significant difference was found in the quality of life (emotional, social function), dignity (symptom distress dimension), and psychological distress in the intervention group through intragroup comparison before and after the intervention. This randomized trial showed that the Heart to Heart Card Game likely alleviates barriers to end-of-life conversations and helps patients with advanced cancer maintain a more stable mental state. This trial has been registered at the Chinese Clinical Trial Registry (registration number: ChiCTR2100049933).",2022,"A significant difference was found in the quality of life (emotional, social function), dignity (symptom distress dimension), and psychological distress in the intervention group through intragroup comparison before and after the intervention.","['patients with advanced cancer maintain a more stable mental state', 'Sixty-six participants', 'Patients with Advanced Cancer', 'patients with advanced cancer receiving home-based palliative care', 'hospitalized patients with advanced cancer']","['Heart to Heart Card Game', 'Receiving Home-Based Palliative Care']","['psychological health outcomes', 'quality of life (global health statues', 'quality of life, dignity, and psychological distress', 'quality of life (emotional, social function), dignity (symptom distress dimension), and psychological distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",66.0,0.0616139,"A significant difference was found in the quality of life (emotional, social function), dignity (symptom distress dimension), and psychological distress in the intervention group through intragroup comparison before and after the intervention.","[{'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'School of Nursing, Wuhan University, No. 115 Donghu Road, Wuhan 430071, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': 'Zhongnan Hospital of Wuhan University, No. 169 Donghu Road, Wuhan 430071, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'School of Nursing, Wuhan University, No. 115 Donghu Road, Wuhan 430071, China.'}, {'ForeName': 'Zifen', 'Initials': 'Z', 'LastName': 'An', 'Affiliation': 'School of Nursing, Wuhan University, No. 115 Donghu Road, Wuhan 430071, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Fang', 'Affiliation': 'School of Nursing, Wuhan University, No. 115 Donghu Road, Wuhan 430071, China.'}, {'ForeName': 'Lanhui', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'School of Nursing, Wuhan University, No. 115 Donghu Road, Wuhan 430071, China.'}, {'ForeName': 'Xianmei', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'School of Nursing, Wuhan University, No. 115 Donghu Road, Wuhan 430071, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, Wuhan University, No. 115 Donghu Road, Wuhan 430071, China.'}]",International journal of environmental research and public health,['10.3390/ijerph19106115']
1246,35635717,"Evaluation of the Effect of Food on the Pharmacokinetics of SHR6390, An Oral CDK4/6 Inhibitor, in Healthy Volunteers.","BACKGROUND AND INTRODUCTION


SHR6390 is a new developed highly effective and selective small-molecule oral CDK4/6 inhibitor. We aimed to evaluate the effect of food on the pharmacokinetics of SHR6390 tablets.
METHODS


In an open-label two-way crossover study, 24 healthy Chinese volunteers were randomly divided into Group A and Group B, and 12 volunteers in each group received a single oral dose of a SHR6390 150-mg tablet under fasting and high-fat conditions. Blood samples were collected and determined for pharmacokinetic analyses. A liquid chromatography-tandem mass spectrometry method was developed and validated for determining the SHR6390 concentration.
RESULTS


The time to maximum plasma concentration was not significantly affected by a high-fat diet. Compared with the fasting group, maximum plasma concentration, i.e., the area under the concentration-time curve (AUC 0-t  and AUC 0-∞ ) was altered significantly, as evidenced by an increase of 56.9%, 38.6%, and 37.5% respectively. We identified seven metabolites of SHR6390 from the plasma samples, and we found no sex differences in metabolic pathways. All treatment-emergent adverse events were Grade 1 or 2.
CONCLUSIONS


Food intake increased the maximum plasma concentration, AUC 0-t , and AUC 0-∞  significantly compared with the fasting condition. Meanwhile, single-dose SHR6390 for two treatment cycles is safe. SHR6390 was administered in a fasting status in the pivotal phase III study (NCT03927456) and chosen for the final drug label.",2022,"Compared with the fasting group, maximum plasma concentration, i.e., the area under the concentration-time curve (AUC 0-t  and AUC 0-∞ ) was altered significantly, as evidenced by an increase of 56.9%, 38.6%, and 37.5% respectively.","['24 healthy Chinese volunteers', 'Healthy Volunteers']","['SHR6390 150-mg tablet under fasting and high-fat conditions', 'SHR6390']","['maximum plasma concentration, i.e., the area under the concentration-time curve (AUC 0-t  and AUC 0-∞ ', 'time to maximum plasma concentration', 'maximum plasma concentration, AUC 0-t , and AUC']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",24.0,0.0143134,"Compared with the fasting group, maximum plasma concentration, i.e., the area under the concentration-time curve (AUC 0-t  and AUC 0-∞ ) was altered significantly, as evidenced by an increase of 56.9%, 38.6%, and 37.5% respectively.","[{'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Ming-Hui', 'Initials': 'MH', 'LastName': 'Hu', 'Affiliation': 'Clinical Laboratory, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Ping-Ping', 'Initials': 'PP', 'LastName': 'Lin', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Yu-Ya', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang, Jiangsu, China.'}, {'ForeName': 'Shao-Rong', 'Initials': 'SR', 'LastName': 'Li', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang, Jiangsu, China.'}, {'ForeName': 'Xiang-Kun', 'Initials': 'XK', 'LastName': 'Li', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang, Jiangsu, China.'}, {'ForeName': 'Chen-Jing', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China. wangchenjing1117@126.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China. caoyu1767@163.com.'}]",Drugs in R&D,['10.1007/s40268-022-00390-7']
1247,35636380,"Evaluation of curcumin as add-on therapy in patients with Parkinson's disease: A pilot randomized, triple-blind, placebo-controlled trial.","BACKGROUND AND OBJECTIVE


Preclinical studies suggest that curcumin might be a potential neuroprotective agent in Parkinson's disease (PD). This clinical trial aimed to evaluate the efficacy of adding nanomicelle curcumin on improving the motor and non-motor symptoms of PD patients and their quality of life.
MATERIAL AND METHODS


Idiopathic PD patients aged ≥30≥ 30 whose symptoms were under control were included in this pilot, randomized, triple-blind, placebo-controlled, add-on trial. Eligible patients were randomly assigned to either the curcumin (n = 30, 80 mg/day) or placebo (n = 30) groups and were followed for nine months. Primary outcomes were the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Parkinson's Disease Questionnaire (PDQ-39). These variables, along with demographic data, drug history, and possible side effects of curcumin, were gathered at the beginning of the study and every three months. A mixed effects model was used to compare the group-by-time interaction, followed by post hoc analysis.
RESULTS


Although the mean MDS-UPDRS and PDQ-39 scores were not significantly different between the curcumin and placebo groups at any time points, MDS-UPDRS part III (P = 0.04) showed a significant difference in its overall trend between the study groups. However, post hoc analysis failed to spot this difference at study time points. The most common side effects of curcumin were nausea and vomiting (P = 0.25) and gastroesophageal reflux (P = 0.42).
CONCLUSION


While curcumin is a well-tolerated natural compound, this trial was unsuccessful in showing its efficacy in quality of life and clinical symptoms of PD patients.",2022,"Although the mean MDS-UPDRS and PDQ-39 scores were not significantly different between the curcumin and placebo groups at any time points, MDS-UPDRS part III (P = 0.04) showed a significant difference in its overall trend between the study groups.","['Idiopathic PD patients aged ≥30≥\xa030 whose symptoms were under control', ""Parkinson's disease (PD"", 'Eligible patients', ""patients with Parkinson's disease""]","['curcumin', 'placebo', 'nanomicelle curcumin']","[""Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Parkinson's Disease Questionnaire (PDQ-39"", 'mean MDS-UPDRS and PDQ-39 scores', 'nausea and vomiting', 'gastroesophageal reflux']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]",,0.321359,"Although the mean MDS-UPDRS and PDQ-39 scores were not significantly different between the curcumin and placebo groups at any time points, MDS-UPDRS part III (P = 0.04) showed a significant difference in its overall trend between the study groups.","[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Ghodsi', 'Affiliation': 'Neurology Department, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: hamidreza.hrg@gmail.com.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Rahimi', 'Affiliation': 'Department of Medical Genetics and Molecular Medicine, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyedeh Mehrnaz', 'Initials': 'SM', 'LastName': 'Aghili', 'Affiliation': 'Internal Medicine Department, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Saberi', 'Affiliation': 'Neurology Department, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shoeibi', 'Affiliation': 'Department of Neurology and HTLV-1 Foundation, Ghaem Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran; Parkinson and Other Movement Disorders Center, Department of Neurosciences, University of California San Diego, La Jolla, CA 92093, USA. Electronic address: Shoeibia@mums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2022.107300']
1248,35636766,The Effect of Mechanical Bowel Preparation on the Surgical Field in Laparoscopic Gynecologic Surgeries: A Prospective Randomized Controlled Trial.,"PURPOSE


To evaluate the effects of mechanical bowel preparation (MBP) on the intraoperative visualization of the surgical field, bowel handling, intestinal load, and overall ease of surgery in patients undergoing elective laparoscopic gynecological surgeries.
METHODS


The patients randomized to a MBP group and a no preparation (NMBP) group. The senior surgeon remained blinded to the bowel regimen used by the patient. Intraoperative visualization of the surgical field, bowel handling, intestinal load, and overall ease of surgery were evaluated using a numeric rating scale (NRS).
RESULTS


We enrolled 120 patients, of whom 109 completed the study, with 51 and 58 patients in the MBP and NMBP groups, respectively. The intraoperative visualization of the surgical field, intestinal load, and NRS scores for overall ease of surgery were better in the NMBP group ( p  = .03,  p  = .048, and  p  = .022, respectively). The results of the assessments also revealed no significant differences in surgical field visualization, ease of bowel handling, overall ease of surgery, or the time that patients experienced passage of flatus between obese (BMI > 30 kg/m 2 ) and non-obese (BMI ≤ 30 kg/m 2 ) patients in the two groups.
CONCLUSIONS


The current study revealed that MBP did not improve the intraoperative visualization of the surgical field or the overall ease of surgery. Moreover, MBP had no benefit when operating on patients who had a high BMI. Therefore, we do not recommend routine MBP before laparoscopic gynecological surgeries.",2022,"The intraoperative visualization of the surgical field, intestinal load, and NRS scores for overall ease of surgery were better in the NMBP group ( p  = .03,  p  = .048, and  p  = .022, respectively).","['Laparoscopic Gynecologic Surgeries', 'patients undergoing elective laparoscopic gynecological surgeries', 'We enrolled 120 patients, of whom 109 completed the study, with 51 and 58 patients in the MBP and NMBP groups, respectively']","['mechanical bowel preparation (MBP', 'no preparation (NMBP', 'Mechanical Bowel Preparation', 'MBP']","['intraoperative visualization of the surgical field, intestinal load, and NRS scores for overall ease of surgery', 'surgical field visualization, ease of bowel handling, overall ease of surgery, or the time that patients experienced passage of flatus', 'numeric rating scale (NRS']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",120.0,0.108581,"The intraoperative visualization of the surgical field, intestinal load, and NRS scores for overall ease of surgery were better in the NMBP group ( p  = .03,  p  = .048, and  p  = .022, respectively).","[{'ForeName': 'Ugur Kemal', 'Initials': 'UK', 'LastName': 'Ozturk', 'Affiliation': ""Department of Gynecologic Oncology, University of Health Sciences Turkey, Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Acar', 'Affiliation': ""Department of General Surgery, University of Health Sciences Turkey, Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Akış', 'Affiliation': 'Department of Gynecologic Oncology, Adiyaman University Faculty of Medicine, Adiyaman, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Keles', 'Affiliation': ""Department of Gynecologic Oncology, University of Health Sciences Turkey, Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Cihat Murat', 'Initials': 'CM', 'LastName': 'Alınca', 'Affiliation': ""Department of Gynecologic Oncology, University of Health Sciences Turkey, Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Api', 'Affiliation': ""Department of Gynecologic Oncology, University of Health Sciences Turkey, Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2022.2081389']
1249,35636921,Phase II trial of weekly erlotinib dosing to reduce duodenal polyp burden associated with familial adenomatous polyposis.,"IMPORTANCE


Patients with familial adenomatous polyposis (FAP) are at markedly increased risk for duodenal adenomas and cancer. Combination sulindac and erlotinib was previously shown to reduce duodenal polyp burden but was associated with a relatively high adverse event (AE) rate.
OBJECTIVE


To evaluate if a once weekly dosing schedule for erlotinib intervention improves the AE profile, while still providing efficacy with respect to reduced polyp burden, in participants with FAP.
DESIGN, SETTING AND PARTICIPANTS


Single-arm trial, enrolling 46 participants with FAP, conducted from October 2017 to September 2019 in eight academic cancer centres.
EXPOSURES


Participants self-administered 350 mg of erlotinib by mouth, one time per week for 6 months.
MAIN OUTCOMES AND MEASURES


Duodenal polyp burden (sum of polyp diameters) was assessed in the proximal duodenum by esophagogastroduodenoscopy performed at baseline and 6 months, with mean per cent change defined as the primary efficacy outcome of interest. Rate of grade 2-3 AEs was evaluated as a co-primary outcome. Secondary outcomes included changes in total duodenal polyp count, along with changes in lower gastrointestinal (GI) polyp burden and count (for participants examined by optional lower endoscopy).
RESULTS


Forty-six participants (mean age, 44.1 years (range, 18-68); women, 22 (48%)) were enrolled; 42 participants completed 6 months of intervention and were included in the per-protocol analysis. Duodenal polyp burden was significantly reduced after 6 months of weekly erlotinib intervention, with a mean per cent change of -29.6% (95% CI, -39.6% to -19.7%; p<0.0001). Similar results were observed in subgroup analyses defined by participants with advanced duodenal polyposis (Spigelman 3) at baseline (mean, -27%; 95% CI, -38.7% to -15.2%; p<0.0001). Post-intervention Spigelman stage was downstaged in 12% of the participants. Lower GI polyp number was also decreased after 6 months of intervention (median, -30.8%; IQR, -47.4% to 0.0%; p=0.0256). Grade 2 or 3 AEs were reported in 71.7% of subjects, with only two experiencing grade 3 toxicity at least possibly related to intervention.
CONCLUSION


In this single-arm, multi-centre trial of participants with FAP, erlotinib one time per week resulted in markedly lower duodenal polyp burden, and modestly reduced lower GI polyp burden, after 6 months of intervention. While AEs were still reported by nearly three-quarters of all participants, these events were generally lower grade and well-tolerated. These findings support further investigation of erlotinib as an effective, acceptable cancer preventive agent for FAP-associated GI polyposis.
TRIAL REGISTRATION NUMBER


NCT02961374.",2022,"Lower GI polyp number was also decreased after 6 months of intervention (median, -30.8%; IQR, -47.4% to 0.0%; p=0.0256).","['Forty-six participants (mean age, 44.1 years (range, 18-68); women, 22 (48%)) were enrolled; 42 participants completed 6 months of intervention and were included in the per-protocol analysis', 'Single-arm trial, enrolling 46 participants with FAP, conducted from October 2017 to September 2019 in eight academic cancer centres', 'Patients with familial adenomatous polyposis (FAP', 'participants with FAP']","['Combination sulindac and erlotinib', 'erlotinib intervention', 'erlotinib']","['duodenal polyp burden', 'Duodenal polyp burden (sum of polyp diameters', 'Lower GI polyp number', 'toxicity', 'changes in total duodenal polyp count, along with changes in lower gastrointestinal (GI) polyp burden and count', 'advanced duodenal polyposis', 'Grade 2 or 3 AEs', 'Duodenal polyp burden']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038792', 'cui_str': 'Sulindac'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0347266', 'cui_str': 'Polyp of duodenum'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0578477', 'cui_str': 'Duodenal polyposis'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0639010', 'cui_str': '3-(2-aminoethyl)-8-(3-(4-fluorobenzoyl)propyl)-4-oxo-1-phenyl-1,3,8-triazaspiro(4.5)decan-4-one'}]",46.0,0.490949,"Lower GI polyp number was also decreased after 6 months of intervention (median, -30.8%; IQR, -47.4% to 0.0%; p=0.0256).","[{'ForeName': 'N Jewel', 'Initials': 'NJ', 'LastName': 'Samadder', 'Affiliation': 'Gastroenterology and Hepatology, Mayo Clinic Minnesota, Rochester, Minnesota, USA Samadder.Jewel@mayo.edu limburg.paul@mayo.edu.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Foster', 'Affiliation': 'Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'McMurray', 'Affiliation': 'Gastroenterology and Hepatology, Mayo Clinic Minnesota, Rochester, Minnesota, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Burke', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Stoffel', 'Affiliation': 'Department of Medicine, University of Michigan Health System, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Kanth', 'Affiliation': 'Gastroenterology & Hepatology, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Cruz-Correa', 'Affiliation': 'Medicine, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vilar', 'Affiliation': 'Clinical Cancer Prevention, UT MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Mankaney', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Navtej', 'Initials': 'N', 'LastName': 'Buttar', 'Affiliation': 'Gastroenterology, Mayo Clinic, Rochester, Minnesota, Rochester, Minnesota, USA.'}, {'ForeName': 'Selvi', 'Initials': 'S', 'LastName': 'Thirumurthi', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Turgeon', 'Affiliation': 'Medicine/Gastroenterology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sossenheimer', 'Affiliation': 'Gastroenterology & Hepatology, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Westover', 'Affiliation': 'Gastroenterology & Hepatology, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Richmond', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Umar', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': ""Della'Zanna"", 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Luz M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, Maryland, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Gastroenterology and Hepatology, Mayo Clinic Minnesota, Rochester, Minnesota, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Limburg', 'Affiliation': 'Gastroenterology and Hepatology, Mayo Clinic Minnesota, Rochester, Minnesota, USA Samadder.Jewel@mayo.edu limburg.paul@mayo.edu.'}]",Gut,['10.1136/gutjnl-2021-326532']
1250,35617452,"Chemical peeling with 35% glycolic acid for the treatment of disseminated facial verruca plana: A randomized, split-face, evaluator-blinded trial.","Disseminated facial verruca plana is a chronic disorder that causes significant psychological distress. However, safe and effective treatment is lacking. This study aimed to explore the efficacy and safety of 35% glycolic acid (GA) for the treatment of disseminated facial verruca plana. A split-face clinical trial was conducted to explore the efficacy and safety of using chemical peeling with 35% GA for the treatment of disseminated facial verruca plana. One side of the face was applied with 35% GA once every fortnight for a total of three times. Adapalene gel was applied every night to the other side of the face as the control. The clearance rate of lesions was evaluated at different time points. Between June 2020 and December 2020, 30 patients with disseminated verruca plana who visited the Dermatology Hospital of Southern Medical University were enrolled. After three chemical peelings with 35% GA that was applied at 2-week intervals, 15 (50%) patients achieved >70% lesion reduction. The same effective rate in the adapalene gel-treated side of the face was documented in eight patients. Subgroup analysis showed a higher clearance rate in patients with a shorter disease duration. Moreover, concurrent improvements in facial roughness were observed in the 35% GA-treated group. Adverse effects including mild erythema and desquamation were observed during chemical peeling with 35% GA. In conclusion, chemical peeling with 35% GA could be a safe and effective option for treating disseminated facial verruca plana, especially for those who desire skin improvement.",2022,Adverse effects including mild erythema and desquamation were observed during chemical peeling with 35% glycolic acid.,"['Between June 2020 and December 2020, thirty patients with disseminated verruca plana who visited the Dermatology Hospital of Southern Medical University were enrolled', 'disseminated facial verruca plana']","['Chemical peeling with 35% glycolic acid', 'Adapalene gel', 'chemical peeling with 35% glycolic acid', '35% glycolic acid', 'adapalene gel']","['efficacy and safety', 'mild erythema and desquamation', 'effective rate', 'facial roughness', 'clearance rate of lesions', 'clearance rate']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0276262', 'cui_str': 'Plane wart'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0343643', 'cui_str': 'Facial wart'}]","[{'cui': 'C0007979', 'cui_str': 'Chemexfoliation of skin'}, {'cui': 'C1533643', 'cui_str': 'Glycolic acid'}, {'cui': 'C1252203', 'cui_str': 'adapalene Topical Gel'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",30.0,0.0311078,Adverse effects including mild erythema and desquamation were observed during chemical peeling with 35% glycolic acid.,"[{'ForeName': 'Zhenfeng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ai', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhenlai', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yi', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Linshan', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yunjing', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Dingheng', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Huizhong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yunling', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lichun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ""Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}]",Dermatologic therapy,['10.1111/dth.15594']
1251,35617368,"Safety and immunogenicity of heterologous boost immunization with an adenovirus type-5-vectored and protein-subunit-based COVID-19 vaccine (Convidecia/ZF2001): A randomized, observer-blinded, placebo-controlled trial.","BACKGROUND


Heterologous boost vaccination has been proposed as an option to elicit stronger and broader, or longer-lasting immunity. We assessed the safety and immunogenicity of heterologous immunization with a recombinant adenovirus type-5-vectored Coronavirus Disease 2019 (COVID-19) vaccine (Convidecia, hereafter referred to as CV) and a protein-subunit-based COVID-19 vaccine (ZF2001, hereafter referred to as ZF).
METHODS AND FINDINGS


We conducted a randomized, observer-blinded, placebo-controlled trial, in which healthy adults aged 18 years or older, who have received 1 dose of Convidecia, with no history of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, were recruited in Jiangsu, China. Sixty participants were randomly assigned (2:1) to receive either 1 dose of ZF2001 or placebo control (trivalent inactivated influenza vaccine (TIV)) administered at 28 days after priming, and received the third injection with ZF2001 at 5 months, referred to as CV/ZF/ZF (D0-D28-M5) and CV/ZF (D0-M5) regimen, respectively. Sixty participants were randomly assigned (2:1) to receive either 1 dose of ZF2001 or TIV administered at 56 days after priming, and received the third injection with ZF2001 at 6 months, referred to as CV/ZF/ZF (D0-D56-M6) and CV/ZF (D0-M6) regimen, respectively. Participants and investigators were masked to the vaccine received but not to the boosting interval. Primary endpoints were the geometric mean titer (GMT) of neutralizing antibodies against wild-type SARS-CoV-2 and 7-day solicited adverse reactions. The primary analysis was done in the intention-to-treat population. Between April 7, 2021 and May 6, 2021, 120 eligible participants were randomly assigned to receive ZF2001/ZF2001 (n = 40) or TIV/ZF2001 (n = 20) 28 days and 5 months post priming, and receive ZF2001/ZF2001 (n = 40) or TIV/ZF2001 (n = 20) 56 days and 6 months post priming. Of them, 7 participants did not receive the third injection with ZF2001. A total of 26 participants (21.7%) reported solicited adverse reactions within 7 days post boost vaccinations, and all the reported adverse reactions were mild, with 13 (32.5%) in CV/ZF/ZF (D0-D28-M5) regimen, 7 (35.0%) in CV/ZF (D0- M5) regimen, 4 (10.0%) in CV/ZF/ZF (D0-D56-M6) regimen, and 2 (10.0%) in CV/ZF (D0-M6) regimen, respectively. At 14 days post first boost, GMTs of neutralizing antibodies in recipients receiving ZF2001 at 28 days and 56 days post priming were 18.7 (95% CI 13.7 to 25.5) and 25.9 (17.0 to 39.3), respectively, with geometric mean ratios of 2.0 (1.2 to 3.5) and 3.4 (1.8 to 6.4) compared to TIV. GMTs at 14 days after second boost of neutralizing antibodies increased to 107.2 (73.7 to 155.8) in CV/ZF/ZF (D0-D28-M5) regimen and 141.2 (83.4 to 238.8) in CV/ZF/ZF (D0-D56-M6) regimen. Two-dose schedules of CV/ZF (D0-M5) and CV/ZF (D0-M6) induced antibody levels comparable with that elicited by 3-dose schedules, with GMTs of 90.5 (45.6, 179.8) and 94.1 (44.0, 200.9), respectively. Study limitations include the absence of vaccine effectiveness in a real-world setting and current lack of immune persistence data.
CONCLUSIONS


Heterologous boosting with ZF2001 following primary vaccination with Convidecia is more immunogenic than a single dose of Convidecia and is not associated with safety concerns. These results support flexibility in cooperating viral vectored and recombinant protein vaccines.
TRIAL REGISTRATION


Study on Heterologous Prime-boost of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine; ClinicalTrial.gov NCT04833101.",2022,Heterologous boosting with ZF2001 following primary vaccination with Convidecia is more immunogenic than a single dose of Convidecia and is not associated with safety concerns.,"['Sixty participants', 'healthy adults aged 18 years or older, who have received 1 dose of Convidecia, with no history of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, were recruited in Jiangsu, China', 'Between April 7, 2021 and May 6, 2021, 120 eligible participants']","['ZF2001 or placebo control (trivalent inactivated influenza vaccine (TIV', 'recombinant adenovirus type-5-vectored', 'CV/ZF (D0-M5) and CV/ZF (D0-M6', 'Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine', 'ZF2001/ZF2001', 'ZF2001 at 6 months, referred to as CV/ZF/ZF (D0-D56-M6) and CV/ZF (D0-M6', 'ZF2001 at 5 months, referred to as CV/ZF/ZF (D0-D28-M5) and CV/ZF (D0-M5', 'ZF2001/ZF2001 (n = 40) or TIV/ZF2001', 'TIV/ZF2001', 'ZF2001 or TIV', 'heterologous boost immunization with an adenovirus type-5-vectored and protein-subunit-based COVID-19 vaccine (Convidecia/ZF2001', 'placebo', 'ZF2001']","['GMTs of neutralizing antibodies', 'antibody levels', 'neutralizing antibodies', 'geometric mean titer (GMT) of neutralizing antibodies against wild-type SARS-CoV-2 and 7-day solicited adverse reactions', 'solicited adverse reactions', 'adverse reactions']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0574482', 'cui_str': 'Tiv language'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0528480', 'cui_str': 'Presenilin 2'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}]","[{'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",60.0,0.54862,Heterologous boosting with ZF2001 following primary vaccination with Convidecia is more immunogenic than a single dose of Convidecia and is not associated with safety concerns.,"[{'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Xiling', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Anhui Zhifei Longcom Biopharmaceutical, Hefei, PR China.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Guanyun County Center for Disease Control and Prevention, Guanyun County, PR China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Lianpan', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Sciences, Beijing, PR China.'}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': 'Vazyme Biotech, Nanjing, PR China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Guanyun County Center for Disease Control and Prevention, Guanyun County, PR China.'}, {'ForeName': 'Lairun', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'School of Public Health, Southeast University, Nanjing, PR China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Fengjuan', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Jingxian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Vazyme Biotech, Nanjing, PR China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Anhui Zhifei Longcom Biopharmaceutical, Hefei, PR China.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Gao', 'Affiliation': 'CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Sciences, Beijing, PR China.'}, {'ForeName': 'Cancan', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Anhui Zhifei Longcom Biopharmaceutical, Hefei, PR China.'}, {'ForeName': 'Jialu', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'School of Public Health, Nanjing Medical University, Nanjing, PR China.'}, {'ForeName': 'Jingxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention, Nanjing, PR China.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention, Nanjing, PR China.'}]",PLoS medicine,['10.1371/journal.pmed.1003953']
1252,35622206,"A Phase 1, Open-Label Study to Evaluate the Effects of Food and Evening Dosing on the Pharmacokinetics of Oral Trofinetide in Healthy Adult Subjects.","BACKGROUND AND OBJECTIVE


Trofinetide, a synthetic analog of tripeptide glycine-proline-glutamate, is an investigational agent for the treatment of Rett syndrome, a neurodevelopmental disorder with affected individuals requiring lifelong support. Food can affect the pharmacokinetic profile of a drug, and this phase 1 study assessed the potential effect of food on the pharmacokinetics of trofinetide. The study also evaluated the potential effect of evening dosing on trofinetide bioavailability and characterized the pharmacokinetic profile of trofinetide in urine.
METHODS


A 60 mL oral solution of trofinetide (12 g) was administered in three dosing periods: morning fasted (A; reference), morning fed (B), and evening fasted (C). Healthy adult subjects (18-45 years) were randomized to sequence ABC (n = 19) or BAC (n = 22). Blood and urine samples were collected at scheduled timepoints for trofinetide pharmacokinetic analysis. Bioequivalence was confirmed if 90% confidence intervals for geometric mean ratio between B/A or C/A fell within 80-125% equivalence limits for area under the concentration-time curve (AUC) and maximum concentration (C max ) in whole blood.
RESULTS


Bioequivalence criteria were met for all conditions (i.e., morning fed vs. morning fasted and evening fasted vs. morning fasted) except C max  in the fed versus fasted condition, which was just below the bioequivalence limit (75.49%), suggesting a negligible food effect and lack of diurnal variation on bioavailability. Trofinetide was primarily excreted unchanged in urine. Trofinetide was well tolerated, and there were no significant changes in vital signs or laboratory parameters.
CONCLUSION


This study supports dosing of trofinetide without regard to food.",2022,"Trofinetide was well tolerated, and there were no significant changes in vital signs or laboratory parameters.
","['Healthy Adult Subjects', 'Healthy adult subjects (18-45 years', 'Rett syndrome, a neurodevelopmental disorder with affected individuals requiring lifelong support']","['60 mL oral solution of trofinetide', 'sequence ABC', 'BAC']","['Blood and urine samples', 'vital signs or laboratory parameters', 'concentration-time\xa0curve (AUC) and maximum concentration (C max ']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035372', 'cui_str': ""Rett's disorder""}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.0453276,"Trofinetide was well tolerated, and there were no significant changes in vital signs or laboratory parameters.
","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Acadia Pharmaceuticals Inc., 12830 El Camino Real, Suite 400, San Diego, CA, USA. mdarwish@acadia-pharm.com.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Youakim', 'Affiliation': 'Acadia Pharmaceuticals Inc., 12830 El Camino Real, Suite 400, San Diego, CA, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Harlick', 'Affiliation': 'Acadia Pharmaceuticals Inc., 12830 El Camino Real, Suite 400, San Diego, CA, USA.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'DeKarske', 'Affiliation': 'Acadia Pharmaceuticals Inc., 12830 El Camino Real, Suite 400, San Diego, CA, USA.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'Acadia Pharmaceuticals Inc., 12830 El Camino Real, Suite 400, San Diego, CA, USA.'}]",Clinical drug investigation,['10.1007/s40261-022-01156-4']
1253,35624116,Response of blood glucose and GLP-1 to different food temperature in normal subject and patients with type 2 diabetes.,"BACKGROUND


Eating behavior is a major factor in type 2 diabetes. We investigated the different responses of glucose-regulating hormones to cold and hot glucose solutions in normal subjects and patients with type 2 diabetes.
METHODS


In this crossover, self-controlled study, normal subjects (N = 19) and patients with type 2 diabetes (N = 22) were recruited and randomly assigned to a hot (50 °C) or a cold (8 °C) oral glucose-tolerance test (OGTT). The subsequent day, they were switched to the OGTT at the other temperature. Blood glucose, insulin, GIP, glucagon-like peptide-1 (GLP-1), and cortisol were measured at 0, 5, 10, 30, 60, and 120 min during each OGTT. After the hot OGTT, all subjects ingested hot (>42 °C) food and water for that day, and ingested food and water at room temperature (≤24 °C) for the day after cold OGTT. All participants had continuous glucose monitoring (CGM) throughout the study.
RESULTS


Compared to cold OGTT, blood glucose was significantly higher with hot OGTT in both groups (both P < 0.05). However, insulin and GLP-1 levels were significantly higher in hot OGTT in normal subjects only (both P < 0.05). The GIP and cortisol responses did not differ with temperature in both groups. CGM showed that normal subjects had significantly higher 24-h mean glucose (MBG) (6.11 ± 0.13 vs. 5.84 ± 0.11 mmol/L, P = 0.021), and standard deviation of MBG with hot meals (0.59 ± 0.06 vs. 0.48 ± 0.05 mmol/L, P = 0.043), T2DM patients had higher MBG only (8.46 ± 0.38 vs. 8.88 ± 0.39 mmol/L, P = 0.022).
CONCLUSIONS


Food temperature is an important factor in glucose absorption and GLP-1 response. These food temperatures elicited differences are lost in type 2 diabetes.",2022,"Compared to cold OGTT, blood glucose was significantly higher with hot OGTT in both groups (both P < 0.05).","['All participants had continuous glucose monitoring (CGM) throughout the study', 'normal subjects (N\u2009=\u200919) and patients with type 2 diabetes (N\u2009=\u200922', 'normal subjects and patients with type 2 diabetes', 'normal subject and patients with type 2 diabetes']","['glucose-regulating hormones to cold and hot glucose solutions', 'hot (50\u2009°C) or a cold (8\u2009°C) oral glucose-tolerance test (OGTT', 'CGM']","['GLP-1), and cortisol', 'Blood glucose, insulin, GIP, glucagon-like peptide-1', 'GIP and cortisol responses', 'blood glucose', '24-h mean glucose (MBG', 'insulin and GLP-1 levels']","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0241132,"Compared to cold OGTT, blood glucose was significantly higher with hot OGTT in both groups (both P < 0.05).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Endocrinology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Kok-Onn', 'Initials': 'KO', 'LastName': 'Lee', 'Affiliation': 'Department of Endocrinology, National university hospital of Singapore, Singapore, Singapore.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. majianhua196503@126.com.'}]",Nutrition & diabetes,['10.1038/s41387-022-00208-0']
1254,35627496,Evaluation of the Effect of Supervised Group Exercise on Self-Reported Sleep Quality in Pregnant Women with or at High Risk of Depression: A Secondary Analysis of a Randomized Controlled Trial.,"Poor sleep quality is common during pregnancy. Our objective was to evaluate the effect of supervised group physical exercise on self-reported sleep quality in pregnant women with or at high risk of depression, and secondly, to describe the association between sleep quality and psychological well-being during pregnancy and postpartum. This was a secondary analysis of a randomized controlled trial ( n  = 282) (NCT02833519) at Rigshospitalet, Denmark. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI), psychological well-being by the five-item WHO Well-Being Index (WHO-5). The intention-to-treat analysis showed no difference in mean global PSQI score neither at 29-34 weeks, 6.56 (95% CI: 6.05-7.07) in the intervention group and 7.00 (95% CI: 6.47-7.53) in the control group,  p  = 0.2, nor at eight weeks postpartum. Women with WHO-5 ≤ 50 reported higher mean global PSQI scores at baseline, 7.82 (95% CI: 7.26-8.38), than women with WHO-5 score &gt; 50, mean 5.42 (95% CI: 5.02-5.82),  p  &lt; 0.0001. A significant difference was also present post-intervention and eight weeks postpartum. No significant effect of group exercise regarding self-reported sleep quality was seen at 29-34 weeks of gestation or postpartum. Low psychological well-being was associated with poor sleep quality during pregnancy and postpartum.",2022,No significant effect of group exercise regarding self-reported sleep quality was seen at 29-34 weeks of gestation or postpartum.,"['n  = 282', 'pregnant women with or at high risk of depression', 'Pregnant Women with or at High Risk of Depression']","['supervised group physical exercise', 'Supervised Group Exercise']","['Self-Reported Sleep Quality', 'Sleep quality', 'sleep quality', 'Pittsburgh Sleep Quality Index (PSQI), psychological well-being by the five-item WHO Well-Being Index (WHO-5', 'mean global PSQI score', 'mean global PSQI scores', 'Poor sleep quality']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.202304,No significant effect of group exercise regarding self-reported sleep quality was seen at 29-34 weeks of gestation or postpartum.,"[{'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Broberg', 'Affiliation': 'Department of Obstetrics, Copenhagen University Hospital-Rigshospitalet, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Damm', 'Affiliation': 'Department of Obstetrics, Copenhagen University Hospital-Rigshospitalet, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Vibe G', 'Initials': 'VG', 'LastName': 'Frokjaer', 'Affiliation': 'Neurobiology Research Unit, Department of Neurology, Copenhagen University Hospital-Rigshospitalet, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Rosthøj', 'Affiliation': 'Danish Cancer Society Research Center, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Mie Gaarskjaer', 'Initials': 'MG', 'LastName': 'de Wolff', 'Affiliation': 'Department of Obstetrics and Gynecology, Copenhagen University Hospital-Hvidovre, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Stinne', 'Initials': 'S', 'LastName': 'Høgh', 'Affiliation': 'Department of Obstetrics, Copenhagen University Hospital-Rigshospitalet, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Tabor', 'Affiliation': 'Department Clinical Medicine, University of Copenhagen, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Hanne Kristine', 'Initials': 'HK', 'LastName': 'Hegaard', 'Affiliation': 'Department of Obstetrics, Copenhagen University Hospital-Rigshospitalet, 2100 Copenhagen, Denmark.'}]",International journal of environmental research and public health,['10.3390/ijerph19105954']
1255,35627475,Nitric-Oxide-Inducing Factors on Vitamin D Changes in Older People Susceptible to Suffer from Sarcopenia.,"Calcium and magnesium, together with vitamin D and the hormones testosterone and cortisol, are key elements in muscle function, to maintain physical fitness. This study aims to analyze if supplementation with NO precursors (L-arginine, L-citrulline and beetroot extract) modulates the circulating levels of calcium, magnesium, vitamin D and steroid hormones in elders. Sixty-one volunteers (65.1 years old, 164.6 cm of height and 71.2 kg of weight) susceptible to develop sarcopenia participated in a physical activity program for 6 weeks. Participants were divided into four groups: one placebo and three taking one of the indicated supplements. Physical capacity was assessed through the following tests: (a) distance covered in 6 min by walking (endurance indicator); (b) hand grip (upper-body strength indicator); (c) time to cover 4 m by walking (speed indicator); and (d) time to perform five full squats (lower-body strength indicator). We concluded that there is a disparity in the association of steroid hormones, vitamin D levels and physical fitness. However, a significant inverse correlation between speed and endurance indicators was observed. Higher circulating vitamin D levels were observed in the L-arginine- and beetroot-supplemented groups. In conclusion, vasodilators increase vitamin D circulating levels that, in the long term, could maintain mineral homeostasis, improving muscular function.",2022,Higher circulating vitamin D levels were observed in the L-arginine- and beetroot-supplemented groups.,"['Older People Susceptible to Suffer from Sarcopenia', 'elders', 'Sixty-one volunteers (65.1 years old, 164.6 cm of height and 71.2 kg of weight) susceptible to develop sarcopenia participated in a physical activity program for 6 weeks']","['placebo', 'Calcium and magnesium, together with vitamin D', 'Nitric-Oxide-Inducing Factors', 'supplementation with NO precursors (L-arginine, L-citrulline and beetroot extract']","['circulating levels of calcium, magnesium, vitamin D and steroid hormones', 'Higher circulating vitamin D levels', 'hand grip (upper-body strength indicator); (c) time to cover 4 m by walking (speed indicator); and (d) time to perform five full squats (lower-body strength indicator', 'Physical capacity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360641', 'cui_str': 'Calcium- and magnesium-containing product'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",61.0,0.0366011,Higher circulating vitamin D levels were observed in the L-arginine- and beetroot-supplemented groups.,"[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Córdova', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Health Sciences, GIR Physical Exercise and Aging, University of Valladolid, Campus Duques de Soria, 42004 Soria, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Caballero-García', 'Affiliation': 'Department of Anatomy and Radiology, Faculty of Health Sciences, GIR Physical Exercise and Aging, University of Valladolid, Campus Los Pajaritos, 42004 Soria, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Noriega-González', 'Affiliation': 'Department of Surgery, Ophthalmology, Otorhinolaryngology and Physiotherapy, Faculty of Medicine, Hospital Clínico Universitario de Valladolid, 47005 Valladolid, Spain.'}, {'ForeName': 'Hugo J', 'Initials': 'HJ', 'LastName': 'Bello', 'Affiliation': 'Department of Mathematics, Escuela de Ingeniería de la Industria Forestal, Agronómica y de la Bioenergía, GIR Physical Exercise and Aging, University of Valladolid, Campus Los Pajaritos, 42004 Soria, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Pons', 'Affiliation': 'Research Group on Community Nutrition and Oxidative Stress, University of Balearic Islands, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Roche', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19105938']
1256,35627452,Comparative Study on the Joint Biomechanics of Different Skill Level Practitioners in Chen-Style Tai Chi Punching.,"PURPOSE


""Yan Shou Hong Cui"" is a representative punch in Chen-style Tai Chi. The training is an important factor in affecting the effect of Tai Chi practice. Joint angles are the most intuitive way to evaluate motion. The purpose of this study is to compare the movements of Tai Chi masters and beginners' movements through the analysis of joint angle and punching effect, and explore the influence of training years on the power generation of Tai Chi punches.
METHODS


There were 14 Chinese Chen-style Tai Chi subjects recruited for this study. They were divided into the master group ( n  = 7, age of 38.14 ± 10.42 years, height of 1.68 ± 0.06 m, weight of 71.33 ± 8.61 kg) and the beginner group ( n  = 7, age of 38.00 ± 11.94 years, height of 1.69 ± 0.07 m, weight of 70.14 ± 9.79 kg). The typical movement from Chen-style Tai Chi is called Yan Shou Hong Cui. All subjects were asked to perform the action three times, and the way of force was applied each time. The kinematic and kinetic characteristics of Tai Chi were analyzed by the VICON 3D motion analysis system (100 Hz) with 16 MX13 cameras, and the punch efficiency was measured by the Chinese Kung Fu Dummy (80,000 Hz).
RESULTS


The experimental results show that the shoulder, elbow, and hand movements of the master group are more precise and the force strength is more vigorous (master group: the peak angular velocity of the shoulder joint was -324.12 ± 50.88°/s, the angular velocity of the elbow joint was -112.83 ± 56.98°/s, and the hand angular velocity was -121.69 ± 49.55°/s; beginner group: shoulder angle velocity was -281.17 ± 30.56°/s, the elbow angle speed was -263.64 ± 68.63°/s, and the hand angle speed was -36.80 ± 12.53°/s). The rotation angle and rotation speed of the hip joint in the master group were significantly higher than those in the beginner group (as for the hip rotation angle, the master group was 64°, which was significantly higher than the beginner group's 44°, and there was a significant difference ( p  = 0.019 &lt; 0.05)). In terms of rotation speed, the peak value of the master group was 370.3 ± 94.8°/s, which was significantly faster than that of the beginner group at 210.4 ± 56.1°/s, and there was a very significant difference ( p  = 0.003 &lt; 0.01). The master group's punch effect acceleration (496.39 ± 256.52 m/s 2 ) was significantly higher than that of the beginner group (396.90 ± 116.79 m/s 2 ).
CONCLUSION


People who practice Tai Chi for a long time differ from the beginners in terms of joint flexibility, punching posture, and the effect of application.",2022,"The rotation angle and rotation speed of the hip joint in the master group were significantly higher than those in the beginner group (as for the hip rotation angle, the master group was 64°, which was significantly higher than the beginner group's 44°, and there was a significant difference ( p  = 0.019 &lt; 0.05)).","['They were divided into the master group ( n  = 7, age of 38.14 ± 10.42 years, height of 1.68 ± 0.06 m, weight of 71.33 ± 8.61 kg) and the beginner group ( n  = 7, age of 38.00 ± 11.94 years, height of 1.69 ± 0.07 m, weight of 70.14 ± 9.79 kg', 'Joint Biomechanics of Different Skill Level Practitioners in Chen-Style Tai Chi Punching', '14 Chinese Chen-style Tai Chi subjects recruited for this study']",[],"['angular velocity of the elbow joint', 'shoulder angle velocity', 'rotation angle and rotation speed of the hip joint']","[{'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517520', 'cui_str': '10.42'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4518239', 'cui_str': '0.07'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0999213', 'cui_str': 'Chen'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0182555', 'cui_str': 'Punch'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0013770', 'cui_str': 'Elbow joint structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}]",,0.00759447,"The rotation angle and rotation speed of the hip joint in the master group were significantly higher than those in the beginner group (as for the hip rotation angle, the master group was 64°, which was significantly higher than the beginner group's 44°, and there was a significant difference ( p  = 0.019 &lt; 0.05)).","[{'ForeName': 'Hongguang', 'Initials': 'H', 'LastName': 'Hua', 'Affiliation': 'Department of Physical Education, Hangzhou Dianzi University, Hangzhou 310018, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'School of International Education, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Education, Zhejiang University, Hangzhou 310058, China.'}]",International journal of environmental research and public health,['10.3390/ijerph19105915']
1257,35627446,Improving the Technique of Pelvic Floor Muscle Contraction in Active Nulliparous Women Attending a Structured High-Low Impact Aerobics Program-A Randomized Control Trial.,"Learning the correct technique of performing pelvic floor muscle (PFM) exercises is a very important factor influencing the effectiveness of this muscle group training. Correctly performed PFM contractions are involved in the urinary continence mechanism. In this study, we tested the hypothesis that a six-week high-low impact aerobics program, supported by one EMG biofeedback session and pelvic floor muscle training, improves the technique of PFM contraction. Participants were 42 active nulliparous women (age 22 ± 2 years, mean ± SD), randomly allocated into intervention ( n  = 18) and control ( n  = 24) groups. We analyzed the technique of PFM contractions, taking into account the order in which selected muscle groups were activated, so called 'firing order'. In both groups, we assessed the PFM contraction technique using surface electromyography (sEMG) and intravaginal probes, before and after six weeks of intervention. The intervention group received one biofeedback session on how to properly contract PFM and afterwards participated in a high-low impact aerobics program supplemented by PFM training. The control group did not receive any intervention. In the pre-test, 67% of the intervention group activated PFM first in order in short, quick contractions. After six weeks of training, this task was correctly performed by 100% of this group ( p  = 0.04). The proper performance of PFM short contraction in the control group was 75% and 67%, before and after intervention, respectively. In the intervention group we also observed statistically significant improvement in the PFM contraction technique in 10-s contractions. The presented intervention was beneficial for the improvement of PFM contraction. High-low impact aerobics, supplemented by one EMG biofeedback session and pelvic floor muscle training can be recommended for active nulliparous women.",2022,"After six weeks of training, this task was correctly performed by 100% of this group ( p  = 0.04).","['Active Nulliparous Women Attending a', 'active nulliparous women', 'Participants were 42 active nulliparous women (age 22 ± 2 years, mean ± SD']","['biofeedback session on how to properly contract PFM and afterwards participated in a high-low impact aerobics program supplemented by PFM training', 'EMG biofeedback session and pelvic floor muscle training', 'Structured High-Low Impact Aerobics Program', 'High-low impact aerobics, supplemented by one EMG biofeedback session and pelvic floor muscle training', 'pelvic floor muscle (PFM) exercises']","['PFM short contraction', 'PFM contraction technique using surface electromyography (sEMG) and intravaginal probes', 'PFM contraction', 'PFM contraction technique']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]",42.0,0.0118149,"After six weeks of training, this task was correctly performed by 100% of this group ( p  = 0.04).","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Piernicka', 'Affiliation': 'Department of Fitness, Gdansk University of Physical Education and Sport, 80-336 Gdańsk, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Błudnicka', 'Affiliation': 'Department of Clinical Physiotherapy and Professional Practices, Gdansk University of Physical Education and Sport, 80-336 Gdańsk, Poland.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Bojar', 'Affiliation': 'Department of Sport Science, Gdansk University of Physical Education and Sport, 80-336 Gdańsk, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Kortas', 'Affiliation': 'Department of Biomechanics and Sports Engineering, Gdansk University of Physical Education and Sport, 80-336 Gdańsk, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Szumilewicz', 'Affiliation': 'Department of Fitness, Gdansk University of Physical Education and Sport, 80-336 Gdańsk, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph19105911']
1258,35627740,Effects of Two Short-Term Aerobic Exercises on Cognitive Function in Healthy Older Adults during COVID-19 Confinement in Japan: A Pilot Randomized Controlled Trial.,"Aerobic exercise improves executive function-which tends to decline with age-and dual-task training with aerobic exercise improves the global cognitive function. However, home-based older adults could not follow these programs due to social isolation during the coronavirus disease 2019 pandemic. Therefore, we conducted a single-blind randomized controlled trial with 88 healthy older adults without dementia or sarcopenia who were randomly assigned into the Nordic walking (aerobic exercise), dance (dual-task training with aerobic exercise), or control group. The participants in both exercise intervention groups trained for 30 min, three times per week, for 4 weeks. All groups consumed amino acid-containing foods three times per week. We found that both exercise intervention groups showed improvements in executive function, while the dance group showed additional improvement in global cognitive function. The dance group showed a higher maximum gait speed, greater improvement in imitation ability, and improved executive function and cognitive function than the Nordic walking group. The intervention programs did not significantly affect the muscle mass or muscle output than the control group; however, both programs improved the participant neurological functions such as the heel lift, with dance training being the most effective intervention. In conclusion, dance training effectively improves cognitive function.",2022,"The dance group showed a higher maximum gait speed, greater improvement in imitation ability, and improved executive function and cognitive function than the Nordic walking group.","['Healthy Older Adults during COVID-19 Confinement in Japan', '88 healthy older adults without dementia or sarcopenia']","['Two Short-Term Aerobic Exercises', 'aerobic exercise', 'exercise intervention', 'Aerobic exercise', 'Nordic walking (aerobic exercise), dance (dual-task training with aerobic exercise), or control group']","['imitation ability, and improved executive function and cognitive function', 'executive function', 'Cognitive Function', 'global cognitive function', 'muscle mass or muscle output', 'cognitive function', 'participant neurological functions such as the heel lift', 'maximum gait speed']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",88.0,0.0357141,"The dance group showed a higher maximum gait speed, greater improvement in imitation ability, and improved executive function and cognitive function than the Nordic walking group.","[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Miyazaki', 'Affiliation': 'Information Somatics Laboratory, Research Center for Advanced Science and Technology, The University of Tokyo, Tokyo 153-8904, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Okuyama', 'Affiliation': 'Information Somatics Laboratory, Research Center for Advanced Science and Technology, The University of Tokyo, Tokyo 153-8904, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Super Reha, LLC., Tokyo 198-0074, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Care 21 Co., Ltd., Osaka 530-0003, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Kumamoto', 'Affiliation': 'General Education Center, Nagano University of Health and Medicine, Nagano 381-2227, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hiyama', 'Affiliation': 'Information Somatics Laboratory, Research Center for Advanced Science and Technology, The University of Tokyo, Tokyo 153-8904, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph19106202']
1259,35627739,What Comes after the Trial? An Observational Study of the Real-World Uptake of an E-Mental Health Intervention by General Practitioners to Reduce Depressive Symptoms in Their Patients.,"Unguided and free e-mental health platforms can offer a viable treatment and self-help option for depression. This study aims to investigate, from a public health perspective, the real-world uptake, benefits, barriers, and implementation support needed by general practitioners (GPs). The study presents data from a spin-off GP survey conducted 2.5 years subsequent to a cluster-randomized trial. A total of  N =  68 GPs (intervention group (IG) GPs = 38, control group (CG) GPs = 30) participated in the survey (response rate 62.4%). Data were collected via postal questionnaires. Overall, 66.2% of the GPs were female. The average age was 51.6 years (SD = 9.4), and 48.5% of the GPs indicated that they continued (IG) or started recommending (CG) the e-mental health intervention under real-world conditions beyond the trial. A number of benefits could be identified, such as ease of integration and strengthening patient activation in disease management. Future implementation support should include providing appealing informational materials and including explainer videos. Workshops, conferences, and professional journals were identified as suitable for dissemination. Social media approaches were less appealing. Measures should be taken to make it easier for health care professionals to use an intervention after the trial and to integrate it into everyday practice.",2022,"A total of  N =  68 GPs (intervention group (IG) GPs = 38, control group (CG) GPs = 30) participated in the survey (response rate 62.4%).",[],['E-Mental Health Intervention'],['Depressive Symptoms'],[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",30.0,0.0427437,"A total of  N =  68 GPs (intervention group (IG) GPs = 38, control group (CG) GPs = 30) participated in the survey (response rate 62.4%).","[{'ForeName': 'Margrit', 'Initials': 'M', 'LastName': 'Löbner', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Luppa', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bleckwenn', 'Affiliation': 'Department of General Practice, Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mehnert-Theuerkauf', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Steffi G', 'Initials': 'SG', 'LastName': 'Riedel-Heller', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19106203']
1260,35627725,Does Training Motivation Influence Resilience Training Outcome on Chronic Stress? Results from an Interventional Study.,"Resilience is understood as an acquired skill which aids in coping with acute and chronic stress. Accordingly, the present study aimed to determine the effect of resilience training on mental health problems during chronic stress. To this end, we conducted a quasi-experimental study with 127 male cadets (mean age: 21 years) of the Swiss Armed Forces officers' school. Whereas the intervention group (IG) received resilience training in addition to the standard officer's education program, the control group (CG) completed the officers' school as usual. Data assessment included pre- and post- measurement of chronic stress, symptoms of depression, and vital exhaustion in both groups. Motivation for training was collected before the first training session. Those who received the resilience training reported no change in chronic stress, whereas participants in the CG showed a significant increase in chronic stress over time ( η p 2  = 0.025). Furthermore, significant differences between IG and CG were only found for symptoms of depression: Participants in the IG reported significantly decreased symptoms of depression, while this was not the case for participants in the CG. Within the IG, participants' training motivation strongly influenced the effectiveness of the resilience training. More specifically, motivated individuals were more likely to benefit from the resilience training than unmotivated ones. Outcome data suggest that resilience training appeared to favorably affect chronic stress and related mental health symptoms; however, the motivation for the training seemed to be an essential prerequisite.",2022,"Furthermore, significant differences between IG and CG were only found for symptoms of depression: Participants in the IG reported significantly decreased symptoms of depression, while this was not the case for participants in the CG.","[""127 male cadets (mean age: 21 years) of the Swiss Armed Forces officers' school"", 'mental health problems during chronic stress']","[""resilience training in addition to the standard officer's education program, the control group (CG) completed the officers' school as usual"", 'resilience training']","['chronic stress', 'symptoms of depression', 'pre- and post- measurement of chronic stress, symptoms of depression, and vital exhaustion', 'chronic stress and related mental health symptoms']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0237758', 'cui_str': 'Non-commissioned officer'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0237758', 'cui_str': 'Non-commissioned officer'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",127.0,0.0060982,"Furthermore, significant differences between IG and CG were only found for symptoms of depression: Participants in the IG reported significantly decreased symptoms of depression, while this was not the case for participants in the CG.","[{'ForeName': 'Madlaina', 'Initials': 'M', 'LastName': 'Niederhauser', 'Affiliation': 'Military Academy, Swiss Federal Institute of Technology ETH Zurich, 8903 Birmensdorf, Switzerland.'}, {'ForeName': 'Regula', 'Initials': 'R', 'LastName': 'Zueger', 'Affiliation': 'Military Academy, Swiss Federal Institute of Technology ETH Zurich, 8903 Birmensdorf, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sefidan', 'Affiliation': 'Military Academy, Swiss Federal Institute of Technology ETH Zurich, 8903 Birmensdorf, Switzerland.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Annen', 'Affiliation': 'Military Academy, Swiss Federal Institute of Technology ETH Zurich, 8903 Birmensdorf, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah 67146, Iran.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi-Bahmani', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah 67146, Iran.'}]",International journal of environmental research and public health,['10.3390/ijerph19106179']
1261,35627704,Kitchen Diet vs. Industrial Diets-Impact on Intestinal Barrier Parameters among Stroke Patients.,"BACKGROUND AND AIMS


Strokes are the second highest cause of death in the world and the most common cause of permanent disability in adults. Intestinal barrier permeability thus contributes to diminished homeostasis within the body, which further affects the healing process and convalescence. Each stroke patient should be administered with ingredients that support the intestinal barrier (e.g., protein and fiber). The aim of this study was to compare the effect of various types of diet (enteral with or without fiber vs. a mixed kitchen diet) on the metabolic activity of intestinal microbiota, namely short chain fatty acids, and gut barrier integrity parameters (zonulin and calprotectin.
METHODS


Patients ( n  = 59), after suffering an ischemic stroke, were randomly allocated to three groups receiving: the kitchen diet ( n  = 32; 1.2 g fiber in 100 mL); Nutrison Energy ®  ( n  = 14; 0.02 g fiber in 100 mL); and Nutrison Diason Energy HP ®  ( n  = 13; 1.8 g fiber in 100 mL). The patients underwent anthropometric measurements and blood samples (for prealbumin measurements), and stool samples (for zonulin and calprotectin determinations) were taken twice, on admission and a week later.
RESULTS


Industrial diets enriched with fiber maintained nutritional status and had a beneficial effect on intestinal barrier permeability parameters. Patients fed with kitchen diets demonstrated a decreased number of lymphocytes, hemoglobin, erythrocytes, and increased serum concentration of C-reactive protein, but improved gut barrier markers. Proton pump inhibitors were shown to increase the inflammatory process in gut.
CONCLUSIONS


Stroke patients should be administered with industrial diets enriched with fiber to improve gut barrier integrity and nutritional parameters.",2022,"Patients fed with kitchen diets demonstrated a decreased number of lymphocytes, hemoglobin, erythrocytes, and increased serum concentration of C-reactive protein, but improved gut barrier markers.","['after suffering an ischemic stroke', 'Stroke Patients', 'Patients ( n  = 59']","['diet (enteral with or without fiber vs. a mixed kitchen diet', 'Proton pump inhibitors', 'kitchen diet ( n  = 32; 1.2 g fiber in 100 mL); Nutrison Energy ®  ( n  = 14; 0.02 g fiber in 100 mL); and Nutrison Diason Energy HP ®', 'Kitchen Diet vs. Industrial Diets-Impact']","['metabolic activity of intestinal microbiota, namely short chain fatty acids, and gut barrier integrity parameters (zonulin and calprotectin', 'gut barrier integrity and nutritional parameters', 'Intestinal Barrier Parameters', 'intestinal barrier permeability parameters', 'blood samples (for prealbumin measurements), and stool samples (for zonulin and calprotectin determinations', 'number of lymphocytes, hemoglobin, erythrocytes, and increased serum concentration of C-reactive protein, but improved gut barrier markers']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0337441', 'cui_str': 'Transthyretin measurement'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0208512,"Patients fed with kitchen diets demonstrated a decreased number of lymphocytes, hemoglobin, erythrocytes, and increased serum concentration of C-reactive protein, but improved gut barrier markers.","[{'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Czerwińska-Rogowska', 'Affiliation': 'Department of Human Nutrition and Metabolomics, Pomeranian Medical University, 71-460 Szczecin, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Skonieczna-Żydecka', 'Affiliation': 'Department od Biochemical Sciences, Pomeranian Medical University, 71-460 Szczecin, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Kaseja', 'Affiliation': 'Department of General and Transplant Surgery, Pomeranian Medical University, 71-460 Szczecin, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Jakubczyk', 'Affiliation': 'Department of Human Nutrition and Metabolomics, Pomeranian Medical University, 71-460 Szczecin, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Palma', 'Affiliation': 'Department od Biochemical Sciences, Pomeranian Medical University, 71-460 Szczecin, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bott-Olejnik', 'Affiliation': 'Neurology Department Regional Specialist Hospital in Gryfice, 72-300 Gryfice, Poland.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Brzozowski', 'Affiliation': 'Neurology Department Regional Specialist Hospital in Gryfice, 72-300 Gryfice, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Stachowska', 'Affiliation': 'Department of Human Nutrition and Metabolomics, Pomeranian Medical University, 71-460 Szczecin, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph19106168']
1262,35627702,Parent Fruit and Vegetable Consumption Outcomes from the Translational 'Time for Healthy Habits' Trial: Secondary Outcomes from a Partially Randomized Preference Trial.,"Healthy eating and active living interventions targeting parents of young children could have benefits for both children and parents. The aim of this study was to assess the effectiveness of two remotely delivered healthy eating and active living interventions delivered at scale to parents, in increasing parent vegetable and fruit consumption (pre-specified secondary outcomes). Parents of children aged 2-6 years residing in New South Wales, Australia (n = 458), were recruited to a partially randomized preference trial consisting of three groups (telephone intervention (n = 95); online intervention (n = 218); written material (Control) (n = 145)). This design allowed parents with a strong preference to select their preferred intervention, and once preference trends had been established, all parents that were subsequently recruited were randomized to obtain robust relative effects. Parent vegetable and fruit consumption was assessed via telephone interview at baseline and 9 months later. At follow-up, randomized parents who received the telephone intervention (n = 73) had significantly higher vegetable consumption compared to those who received the written control (n = 81) (+0.41 serves/day,  p  = 0.04), but there were no differences in parents allocated to intervention groups based on preference. No differences in fruit consumption were found for randomized or preference participants for either the telephone or online intervention. There may be some benefit to parents participating in the Healthy Habits Plus (telephone-based) intervention aimed at improving the eating behaviors of their children.",2022,"At follow-up, randomized parents who received the telephone intervention (n = 73) had significantly higher vegetable consumption compared to those who received the written control (n = 81) (+0.41 serves/day,  p  = 0.04), but there were no differences in parents allocated to intervention groups based on preference.","['Healthy eating and active living interventions targeting parents of young children', 'parents with a strong preference to select their preferred intervention, and once preference trends had been established, all parents that were subsequently recruited', 'Parents of children aged 2-6 years residing in New South Wales, Australia (n = 458', ""Healthy Habits' Trial""]","['healthy eating and active living interventions', 'online intervention (n = 218); written material (Control', 'telephone intervention']","['vegetable consumption', 'fruit consumption']","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}]",458.0,0.0422295,"At follow-up, randomized parents who received the telephone intervention (n = 73) had significantly higher vegetable consumption compared to those who received the written control (n = 81) (+0.41 serves/day,  p  = 0.04), but there were no differences in parents allocated to intervention groups based on preference.","[{'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Wyse', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, University Drive, Newcastle, NSW 2308, Australia.'}, {'ForeName': 'Jacklyn K', 'Initials': 'JK', 'LastName': 'Jackson', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, University Drive, Newcastle, NSW 2308, Australia.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Hammersley', 'Affiliation': 'Early Start, Faculty of the Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stacey', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, University Drive, Newcastle, NSW 2308, Australia.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Jones', 'Affiliation': 'Early Start, Faculty of the Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Okely', 'Affiliation': 'Early Start, Faculty of the Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Centre for Population Health, New South Wales Ministry of Health, St. Leonards, Sydney, NSW 2065, Australia.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, University Drive, Newcastle, NSW 2308, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, University Drive, Newcastle, NSW 2308, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Innes-Hughes', 'Affiliation': 'Centre for Population Health, New South Wales Ministry of Health, St. Leonards, Sydney, NSW 2065, Australia.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Centre for Population Health, New South Wales Ministry of Health, St. Leonards, Sydney, NSW 2065, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gillham', 'Affiliation': 'Hunter New England Population Health, Wallsend, Newcastle, NSW 2287, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Darwin, NT 0800, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph19106165']
1263,35633604,Bringing disability experiences front stage: Research-based theatre as a teaching approach to promote inclusive health education.,"BACKGROUND


Despite efforts to promote inclusion of people living with disabilities in health and human service education and professions, students and clinicians living with disabilities continue to face powerful barriers, arising most notably from the stigma and negative attitudes of their peers. Increased awareness of these lived experiences are needed to affect attitudinal changes and reduce barriers to participation in those professions. To achieve this, information (stories) must be presented to learners in a way that promotes emotional engagement and highlights these issues from multiple perspectives. The following study measures the impact of a Research based Theatre play, based on the collected experiences of people living with disabilities in health and human service professions, as a teaching approach for knowledge and attitudinal change among audiences.
METHOD


This mixed-methods study (pre and post surveys, groups and individual interviews) aimed at measuring the impact (knowledge and attitudinal change) incurred among audience members. In total, a 174 students, faculty, staff, and clinicians in health and human service professions across two major Canadian cities completed the surveys before and after witnessing the play. Of these, 20 participants also participated in follow-up interviews. Two-way repeated measures ANOVA was used to compare the pre and post surveys while thematic content analysis was used for the interviews.
RESULTS


Two main themes emerged from combined analysis of both the quantitative and qualitative data. First, quantitative data revealed a significant change in participants' attitudes towards people living with disabilities which was corroborated by interview participants who expressed more comfort in their interactions with students and clinicians living with disabilities. Second, learners also reported meaningful and statistically significant change in their knowledge about the experiences of health and human service professionals living with disabilities.
CONCLUSIONS


The results of this study support applying Research-based Theatre as a teaching approach that can promote knowledge and attitudinal change among audiences and increase the inclusion and equity of people living with disabilities in health and human service education. Future research in this area might investigate Research-based Theatre's pedagogical impact using a randomized control design and measuring longer term impact.",2022,"First, quantitative data revealed a significant change in participants' attitudes towards people living with disabilities which was corroborated by interview participants who expressed more comfort in their interactions with students and clinicians living with disabilities.","['20 participants also participated in follow-up interviews', 'people living with disabilities in health and human service education and professions, students and clinicians living with disabilities', 'people living with disabilities in health and human service professions', 'people living with disabilities in health and human service education', '174 students, faculty, staff, and clinicians in health and human service professions across two major Canadian cities completed the surveys before and after witnessing the play']",[],[],"[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",[],[],,0.025128,"First, quantitative data revealed a significant change in participants' attitudes towards people living with disabilities which was corroborated by interview participants who expressed more comfort in their interactions with students and clinicians living with disabilities.","[{'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Jarus', 'Affiliation': 'Occupational Science and Occupational Therapy department, The University of British Columbia, Canada; Research-based Theatre Collaborative, The University of British Columbia, Canada. Electronic address: tal.jarus@ubc.ca.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Mayer', 'Affiliation': 'Occupational Science and Occupational Therapy department, The University of British Columbia, Canada; Research-based Theatre Collaborative, The University of British Columbia, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gross', 'Affiliation': 'Occupational Science and Occupational Therapy department, The University of British Columbia, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Department of Language and Literacy Education, The University of British Columbia, Canada; Research-based Theatre Collaborative, The University of British Columbia, Canada.'}, {'ForeName': 'Laura Yvonne', 'Initials': 'LY', 'LastName': 'Bulk', 'Affiliation': 'Occupational Science and Occupational Therapy department, The University of British Columbia, Canada; Research-based Theatre Collaborative, The University of British Columbia, Canada.'}, {'ForeName': 'Laen A D', 'Initials': 'LAD', 'LastName': 'Hershler', 'Affiliation': 'Department of Language and Literacy Education, The University of British Columbia, Canada; Research-based Theatre Collaborative, The University of British Columbia, Canada.'}, {'ForeName': 'Jennica', 'Initials': 'J', 'LastName': 'Nichols', 'Affiliation': 'Research-based Theatre Collaborative, The University of British Columbia, Canada; School of Population and Public Health, The University of British Columbia, Canada.'}, {'ForeName': 'Shahbano', 'Initials': 'S', 'LastName': 'Zaman', 'Affiliation': 'Occupational Science and Occupational Therapy department, The University of British Columbia, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Belliveau', 'Affiliation': 'Department of Language and Literacy Education, The University of British Columbia, Canada; Research-based Theatre Collaborative, The University of British Columbia, Canada.'}]",Nurse education today,['10.1016/j.nedt.2022.105408']
1264,35640438,Effectiveness of Kegel exercise and lubricant gel for improving sexual function in menopausal women: A randomized trial.,"BACKGROUND


There are different approaches to improving sexual function among menopausal women including Kegel exercise and using lubricant gel. However, it is not clear which of these methods could be more effective. This study aimed to compare the effectiveness of these two methods on sexual function in menopausal women.
METHODS


The present randomized trial was conducted on 150 menopausal women in Dezful, Iran. Eligible women were randomly assigned to two interventions (Kegel exercise and lubricating gel) and one control groups. The Kegel exercise group received training on the exercise method; the lubricant gel group was given the lubricating gel and taught how it should be used, while the control group received no intervention. The interventions continued for 12 weeks, and sexual function was assessed at four times: baseline, one month, two months, and three-months follow-up. Chi-square test, one-way analysis of variance, repeated measures, analysis of covariance, and logistic regression analyses were applied.
RESULTS


No significant difference was found between groups regarding demographic and obstetrics variables. After adjusting for the baseline sexual function score, covariate analysis showed a significant improvement in sexual function in Kegel and gel groups as compared to the control group. Similarly, within-group comparison using repeated measures analysis showed that sexual function in both Kegel and gel groups improved during the study follow-up periods while women in the control group showed no changes in their sexual function. Finally, logistic regression analysis indicated a significantly higher odds ratio for better sexual function in both Kegel and gel groups. However, the odds of better sexual function for the Kegel group (OR = 4.19, 95% CI: 1.81-9.72, P = 0.001) was higher than the gel group (OR = 3.7, 95% CI: 1.42-7.52, P = 0.005).
CONCLUSION


Both Kegel exercise and gel were effectively improved sexual function in menopausal women. However, the findings indicated that sexual function was more likely to be improved after using Kegel exercise than using lubricant gel.
TRIAL REGISTRATION


IRCT20150128020854N7. Registered 30 September 2019, https://fa.irct.ir/user/trial/40878/view.",2022,"However, the odds of better sexual function for the Kegel group (OR = 4.19, 95% CI: 1.81-9.72, P = 0.001) was higher than the gel group (OR = 3.7, 95% CI: 1.42-7.52, P = 0.005).
","['menopausal women including', 'menopausal women', 'Eligible women', '150 menopausal women in Dezful, Iran']","['Kegel exercise and lubricant gel', 'Kegel exercise group received training on the exercise method; the lubricant gel group was given the lubricating gel and taught how it should be used, while the control group received no intervention', 'interventions (Kegel exercise and lubricating gel', 'Kegel exercise', 'Kegel exercise and using lubricant gel']",['sexual function'],"[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}, {'cui': 'C0282222', 'cui_str': 'Lubricant'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}]",150.0,0.0150382,"However, the odds of better sexual function for the Kegel group (OR = 4.19, 95% CI: 1.81-9.72, P = 0.001) was higher than the gel group (OR = 3.7, 95% CI: 1.42-7.52, P = 0.005).
","[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': 'Student Research Committee, Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hedyeh', 'Initials': 'H', 'LastName': 'Riazi', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: h.riazi@sbmu.ac.ir.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Simbar', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Population Health Research Group, Health Metrics Research Center, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran; Faculty of Humanity Sciences, University of Science and Culture, Tehran, Iran. Electronic address: montazeri@acecr.ac.ir.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2022.05.022']
1265,35640310,Prospective relations between anxiety sensitivity and transdiagnostic anxiety following cognitive-behavioral therapy: Evidence from the Coordinated Anxiety Learning management trial.,"Previous research has implicated reductions in anxiety sensitivity (AS) - the dispositional tendency to fear anxiety-related sensations - as critical to change during cognitive behavioral therapy (CBT) for anxiety. However, the relationship of AS to anxiety symptom remittance following CBT remains largely unknown. To address this gap, the current study evaluated prospective associations between AS and symptoms of various anxiety disorders following completion of the Coordinated Anxiety Learning and Management (CALM) study- a large clinical trial evaluating the efficacy of a brief, computer-facilitated CBT intervention for transdiagnostic anxiety within primary care. Participants were randomized to CALM (n = 460) or a control treatment (n = 501) and completed self-report measures of general and disorder-specific anxiety symptoms at pretreatment and at 6-month, 12-month, and 18-month follow-up. Longitudinal relations between AS and each anxiety measure across timepoints and within each treatment group were assessed using cross-lagged panel models. Results indicated that higher AS following CALM predicted greater anxiety symptoms at the subsequent timepoint for all anxiety symptoms except social anxiety symptoms. Higher anxiety following treatment also predicted later AS. These findings implicate AS as an indicator of transdiagnostic anxiety remittance and suggest that targeting AS could be useful for reducing clinical anxiety relapse following CBT.",2022,Results indicated that higher AS following CALM predicted greater anxiety symptoms at the subsequent timepoint for all anxiety symptoms except social anxiety symptoms.,['transdiagnostic anxiety within primary care'],"['CALM', 'cognitive-behavioral therapy', 'control treatment', 'computer-facilitated CBT intervention', 'Coordinated Anxiety Learning and Management (CALM']","['anxiety symptoms', 'anxiety symptoms except social anxiety symptoms', 'Higher anxiety', 'anxiety sensitivity and transdiagnostic anxiety', 'clinical anxiety relapse']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",501.0,0.0155246,Results indicated that higher AS following CALM predicted greater anxiety symptoms at the subsequent timepoint for all anxiety symptoms except social anxiety symptoms.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'VA San Diego Healthcare System, Center of Excellence for Stress and Mental Health, USA; University of California San Diego, Department of Psychiatry, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Campbell-Sills', 'Affiliation': 'University of California San Diego, Department of Psychiatry, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Chavira', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Craske', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sherbourne', 'Affiliation': 'RAND Corporation, USA.'}, {'ForeName': 'Greer', 'Initials': 'G', 'LastName': 'Sullivan', 'Affiliation': 'University of California, Riverside, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Roy-Byrne', 'Affiliation': 'University of Washington School of Medicine, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'University of California San Diego, Department of Psychiatry, USA; University of California San Diego, Department of Family Medicine and Public Health, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bomyea', 'Affiliation': 'VA San Diego Healthcare System, Center of Excellence for Stress and Mental Health, USA; University of California San Diego, Department of Psychiatry, USA. Electronic address: jbomyea@health.ucsd.ed.'}]",Behaviour research and therapy,['10.1016/j.brat.2022.104119']
1266,35624347,Vericiguat: A Review in Chronic Heart Failure with Reduced Ejection Fraction.,"Vericiguat (Verquvo ® ) is the first oral soluble guanylate cyclase (sGC) stimulator to be approved for the treatment of adults with symptomatic, chronic heart failure with reduced ejection fraction (HFrEF). In the phase III VICTORIA trial, vericiguat added to standard of care (SOC) was associated with a significantly lower risk of the primary composite endpoint of death from cardiovascular (CV) causes or first hospitalization from heart failure (HHF) than placebo added to SOC in adults with chronic HFrEF. The risk of all-cause mortality or first HHF (secondary composite endpoint) and the total number of HHF were also statistically significantly reduced by vericiguat therapy. Vericiguat showed no benefit with respect to the primary endpoint in a subgroup of patients with grossly elevated N-terminal pro-brain natriuretic peptide levels. Vericiguat was generally well tolerated; the most common treatment-related adverse event (AE) was hypotension. AEs of special interest included symptomatic hypotension and syncope, which occurred with low incidences that were similar between treatment groups. Thus, vericiguat is an effective and generally well-tolerated treatment option in patients with symptomatic, chronic HFrEF who have experienced a recent worsening event, expanding the options currently available for chronic HFrEF management.",2022,"AEs of special interest included symptomatic hypotension and syncope, which occurred with low incidences that were similar between treatment groups.","['adults with symptomatic, chronic heart failure with reduced ejection fraction (HFrEF', 'adults with chronic HFrEF', 'patients with symptomatic, chronic HFrEF who have experienced a recent worsening event']","['Vericiguat', 'placebo', 'Vericiguat (Verquvo ® ']","['total number of HHF', 'tolerated', 'symptomatic hypotension and syncope']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}]",,0.0805795,"AEs of special interest included symptomatic hypotension and syncope, which occurred with low incidences that were similar between treatment groups.","[{'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. demail@springer.com.'}, {'ForeName': 'Yvette N', 'Initials': 'YN', 'LastName': 'Lamb', 'Affiliation': 'Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-022-00538-5']
1267,35627346,Effects of Robot-Assisted Gait Training with Body Weight Support on Gait and Balance in Stroke Patients.,"This study investigated the effects of robot-assisted gait training with body weight support on gait and balance in stroke patients. The study participants comprised 24 patients diagnosed with stroke. Patients were randomly assigned to four groups of six: robot A, B, C, and non-robot. The body weight support (BWS) for the harness of the robot was set to 30% of the patient's body weight in robot group A, 50% in robot group B, and 70% in robot group C. All experimental groups received robot-assisted gait training and general physical therapy. The non-robot group underwent gait training using a p-bar, a treadmill, and general physical therapy. The intervention was performed for 30 min a day, five times a week, for 6 weeks. All participants received the intervention after the pre-test. A post-test was performed after all of the interventions were completed. Gait was measured using a 10 m Walking test (10MWT) and the timed up and go (TUG) test. Balance was assessed using the Berg Balance Scale (BBS). Robot groups A, B, and C showed significantly better 10MWT results than did the non-robot group ( p  &lt; 0.5). TUG was significantly shorter in robot groups A, B, and C than in the non-robot group ( p  &lt; 0.5). The BBS scores for robot group A improved significantly more than did those for robot groups B and C and the non-robot group ( p  &lt; 0.5), indicating that robot-assisted gait training with body weight support effectively improved the gait of stroke patients.",2022,"TUG was significantly shorter in robot groups A, B, and C than in the non-robot group ( p  &lt; 0.5).","['Stroke Patients', 'stroke patients', '24 patients diagnosed with stroke']","['Robot-Assisted Gait Training with Body Weight Support', 'robot-assisted gait training and general physical therapy', 'robot-assisted gait training with body weight support', 'gait training using a p-bar, a treadmill, and general physical therapy']","['gait of stroke patients', 'Gait and Balance', 'TUG', 'body weight support (BWS', 'Berg Balance Scale (BBS', 'gait and balance', 'BBS scores']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.00673336,"TUG was significantly shorter in robot groups A, B, and C than in the non-robot group ( p  &lt; 0.5).","[{'ForeName': 'Wonho', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, Gachon University, Incheon 21936, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph19105814']
1268,35627343,Health Literacy among Pregnant Women in a Lifestyle Intervention Trial.,"Health literacy plays a crucial role during pregnancy, influencing the mother's health behavior which in turn affects the unborn child's health. To date, there are only few studies that report on health literacy among pregnant women or even interventions to promote health literacy. GeMuKi (acronym for ""Gemeinsam Gesund: Vorsorge plus für Mutter und Kind""-Strengthening health promotion: enhanced check-up visits for mother and child) is a cluster-randomized controlled trial, aimed at improving health literacy in pregnant women by means of a lifestyle intervention in the form of brief counseling. The women in the intervention group receive counseling on lifestyle topics, such as nutrition and physical activity, during their regular prenatal check-ups. The counseling is tailored to the needs of pregnant women. Demographic data is collected at baseline using a paper-based questionnaire. Data on health literacy is collected using the Health Literacy Survey Europe with 16 items (HLS-EU-16) at baseline and the Brief Health Literacy Screener (BHLS) questionnaire at two points during the pregnancy by means of an app, which was developed specifically for the purpose of the project. The results of the study indicate that around 61.9% of the women participating in the GeMuKi study have an adequate level of health literacy at baseline. The regression analyses (general estimating equations) showed no significant effect of the GeMuKi intervention on general health literacy as measured by the BHLS (ß = 0.086, 95% CI [-0.016-0.187]). However, the intervention was significantly positively associated with pregnancy specific knowledge on lifestyle (ß = 0.089, 95% CI [0.024-0.154]). The results of this study indicate that GeMuKi was effective in improving specific pregnancy related knowledge, but did not improve general health literacy.",2022,"However, the intervention was significantly positively associated with pregnancy specific knowledge on lifestyle (ß = 0.089, 95% CI [0.024-0.154]).","['Pregnant Women in a Lifestyle Intervention Trial', 'pregnant women']","['counseling on lifestyle topics, such as nutrition and physical activity, during their regular prenatal check-ups', 'GeMuKi intervention', 'GeMuKi', 'acronym for ""Gemeinsam Gesund: Vorsorge plus für Mutter und Kind']","['adequate level of health literacy', 'Brief Health Literacy Screener (BHLS) questionnaire', 'pregnancy specific knowledge on lifestyle', 'general health literacy', 'Health Literacy']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1956259', 'cui_str': 'Acronyms'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]",,0.0303174,"However, the intervention was significantly positively associated with pregnancy specific knowledge on lifestyle (ß = 0.089, 95% CI [0.024-0.154]).","[{'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Nawabi', 'Affiliation': 'Institute for Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Krebs', 'Affiliation': 'Institute for Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lorenz', 'Affiliation': 'Institute for Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}, {'ForeName': 'Arim', 'Initials': 'A', 'LastName': 'Shukri', 'Affiliation': 'Institute for Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Alayli', 'Affiliation': 'Institute for Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Stock', 'Affiliation': 'Institute for Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19105808']
1269,35627640,"Effect of Chest Resistance and Expansion Exercises on Respiratory Muscle Strength, Lung Function, and Thoracic Excursion in Children with a Post-Operative Congenital Diaphragmatic Hernia.","BACKGROUND


Congenital diaphragmatic hernia (CDH) is a life-threatening condition with long-term complications including respiratory tract infections, respiratory muscle weakness, and abnormal lung functions. This study was designed to ascertain the effects of chest resistance and chest expansion exercises on respiratory muscle strength, lung function, and chest mobility in children with post-operative CDH.
METHODS


This randomized controlled clinical study was conducted in the outpatient physiotherapy clinic at Prince Sattam bin Abdulaziz University. Thirty-two children with CDH aged 10-14 years between May 2020 and February 2021 were randomly allocated to the study group ( n  = 16) and the control group ( n  = 16). The control group underwent a usual chest physiotherapy program; however, the study group underwent a 12-week chest resistance exercise combined with chest expansion exercise in addition to usual chest physiotherapy, with three sessions per week. Respiratory muscle strength, lung function, and thoracic excursion were assessed pre- and post-treatment.
RESULTS


Using the 2 × 2 repeated ANOVA, significant time × group interactions were detected in favor of the study group, FVC (F = 4.82, 95% CI = -15.6 to -0.97,  p  = 0.005, and η 2  = 0.16), FEV1 (F = 4.54, 95% CI = -11.99 to -2.8,  p  ˂ 0.001, and η 2  = 0.14), PImax (F = 5.12, 95% CI = -15.71 to -5.3,  p  ˂ 0.001, and η 2  = 0.15), and thoracic excursion (F = 4.41, 95% CI = -2.04 to -0.16,  p  = 0.036, and η 2  = 0.17).
CONCLUSIONS


Concurrent chest resistance and expansion exercises may improve respiratory muscle strength, lung function, and thoracic excursion in children with post-operative CDH. The study findings suggest that concurrent chest and chest expansion exercises be part of an appropriate pulmonary rehabilitation program in children with a history of CDH.",2022,"CONCLUSIONS


Concurrent chest resistance and expansion exercises may improve respiratory muscle strength, lung function, and thoracic excursion in children with post-operative CDH.","['children with a history of CDH', 'Congenital diaphragmatic hernia (CDH', 'children with post-operative CDH', 'children with post-operative CDH.\nMETHODS', 'outpatient physiotherapy clinic at Prince Sattam bin Abdulaziz University', 'Thirty-two children with CDH aged 10-14 years between May 2020 and February 2021', 'Children with a Post-Operative Congenital Diaphragmatic Hernia']","['Chest Resistance and Expansion Exercises', 'chest resistance exercise combined with chest expansion exercise in addition to usual chest physiotherapy', 'usual chest physiotherapy program', 'chest resistance and chest expansion exercises']","['FVC', 'Respiratory muscle strength, lung function, and thoracic excursion', 'respiratory muscle strength, lung function, and chest mobility', 'Respiratory Muscle Strength, Lung Function, and Thoracic Excursion', 'thoracic excursion', 'FEV1', 'respiratory muscle strength, lung function, and thoracic excursion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0235833', 'cui_str': 'Congenital diaphragmatic hernia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0574497', 'cui_str': 'Edo language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",32.0,0.0124108,"CONCLUSIONS


Concurrent chest resistance and expansion exercises may improve respiratory muscle strength, lung function, and thoracic excursion in children with post-operative CDH.","[{'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Azab', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'Abbas Elbakry A', 'Initials': 'AEA', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pediatrics, College of Medicine, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'Mohammed Ibrahim', 'Initials': 'MI', 'LastName': 'Hajelbashir', 'Affiliation': 'Department of Pediatrics, College of Medicine, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'FatmaAlzahraa H', 'Initials': 'FH', 'LastName': 'Kamel', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza 12613, Egypt.'}, {'ForeName': 'Maged A', 'Initials': 'MA', 'LastName': 'Basha', 'Affiliation': 'Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Buraidah 51452, Saudi Arabia.'}]",International journal of environmental research and public health,['10.3390/ijerph19106101']
1270,35627616,Effects of a 6-Month Aerobic Exercise Intervention on Mood and Amygdala Functional Plasticity in Young Untrained Subjects.,"Acute exercise has beneficial effects on mood and is known to induce modulations in functional connectivity (FC) within the emotional network. However, the long-term effects of exercise on affective brain circuits remain largely unknown. Here, we investigated the effects of 6 months of regular exercise on mood, amygdala structure, and functional connectivity. This study comprised  N  = 18 healthy sedentary subjects assigned to an intervention group (IG; 23.9 ± 3.9 years; 3 trainings/week) and  N  = 10 subjects assigned to a passive control group (CG; 23.7 ± 4.2 years). At baseline and every two months, performance diagnostics, mood questionnaires, and structural and resting-state-fMRI were conducted. Amygdala-nuclei segmentation and amygdala-to-whole-brain FC analysis were performed. Linear mixed effects models and correlation analyses were conducted between FC, relVO 2max , and mood scores. Data showed increases in relVO 2max  exclusively in the IG. Stronger anticorrelation in amygdala-precuneus FC was found, along with a stronger positive correlation in the amygdala-temporal pole FC in the IG after 4 and 6 months, while mood and amygdala volume did not reveal significant interactions. The relVO 2max /amygdala-temporal pole FC correlated positively, and the amygdala-precuneus/amygdala-temporal pole FC correlated negatively. Findings suggest that exercise induced long-term modulations of the amygdala FC with the precuneus and temporal pole, shedding light on potential mechanisms by which exercise has positive influences on mood-related networks, typically altered in affective disorders.",2022,Acute exercise has beneficial effects on mood and is known to induce modulations in functional connectivity (FC) within the emotional network.,"['Young Untrained Subjects', 'N  = 18 healthy sedentary subjects']","['regular exercise', '6-Month Aerobic Exercise Intervention']","['FC, relVO 2max , and mood scores', 'mood, amygdala structure, and functional connectivity', 'performance diagnostics, mood questionnaires, and structural and resting-state-fMRI', 'Mood and Amygdala Functional Plasticity', 'relVO 2max', 'amygdala-precuneus FC', 'relVO 2max /amygdala-temporal pole FC']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0149552', 'cui_str': 'Structure of temporal pole'}]",18.0,0.0309169,Acute exercise has beneficial effects on mood and is known to induce modulations in functional connectivity (FC) within the emotional network.,"[{'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Maurer', 'Affiliation': 'Clinical Functional Imaging Lab, Department of Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Klein', 'Affiliation': 'Clinical Functional Imaging Lab, Department of Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.'}, {'ForeName': 'Jannik', 'Initials': 'J', 'LastName': 'Claus', 'Affiliation': 'Clinical Functional Imaging Lab, Department of Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Upadhyay', 'Affiliation': 'Clinical Functional Imaging Lab, Department of Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Henschel', 'Affiliation': 'German Center for Neurodegenerative Diseases, Venusberg-Campus 1, Building 99, 53127 Bonn, Germany.'}, {'ForeName': 'Jason Anthony', 'Initials': 'JA', 'LastName': 'Martin', 'Affiliation': 'Clinical Functional Imaging Lab, Department of Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Scheef', 'Affiliation': 'Clinical Functional Imaging Lab, Department of Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Daamen', 'Affiliation': 'German Center for Neurodegenerative Diseases, Venusberg-Campus 1, Building 99, 53127 Bonn, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schörkmaier', 'Affiliation': 'German Center for Neurodegenerative Diseases, Venusberg-Campus 1, Building 99, 53127 Bonn, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Stirnberg', 'Affiliation': 'German Center for Neurodegenerative Diseases, Venusberg-Campus 1, Building 99, 53127 Bonn, Germany.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Stöcker', 'Affiliation': 'German Center for Neurodegenerative Diseases, Venusberg-Campus 1, Building 99, 53127 Bonn, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Radbruch', 'Affiliation': 'Department of Neuroradiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.'}, {'ForeName': 'Ulrike I', 'Initials': 'UI', 'LastName': 'Attenberger', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reuter', 'Affiliation': 'German Center for Neurodegenerative Diseases, Venusberg-Campus 1, Building 99, 53127 Bonn, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Boecker', 'Affiliation': 'Clinical Functional Imaging Lab, Department of Diagnostic and Interventional Radiology, University Hospital Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19106078']
1271,35627413,Effectiveness of Interdisciplinary Teaching on Creativity: A Quasi-Experimental Study.,"Little is known about the effectiveness of Interdisciplinary teaching (IDT) in higher education, particularly for healthcare education in Taiwan. It is vital to determine if IDT could enhance divergent creative thinking and team creativity among nursing students. A quasi-experimental study with a pretest-posttest design. Students enrolled in a capstone nursing course for the development of healthcare-related products were divided into two groups. The intervention group ( n  = 61) was taught creative thinking skills with IDT by faculty. The control group ( n  = 84) was taught by nursing faculty with traditional teaching. This study found that students who received the IDT intervention scored significantly higher on measures of creative thinking and team creativity compared with students in the control group. These findings suggest integrating IDT from nursing and design faculty into the teaching curriculum to foster students' creative thinking abilities when formulating interdisciplinary student teams to develop innovative, creative healthcare products.",2022,This study found that students who received the IDT intervention scored significantly higher on measures of creative thinking and team creativity compared with students in the control group.,"['healthcare education in Taiwan', 'Students enrolled in a capstone nursing course for the development of healthcare-related products', 'nursing students']","['Interdisciplinary Teaching', 'Interdisciplinary teaching (IDT', 'IDT intervention']","['Creativity', 'creative thinking and team creativity']","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010297', 'cui_str': 'Creative thought'}]",,0.0306329,This study found that students who received the IDT intervention scored significantly higher on measures of creative thinking and team creativity compared with students in the control group.,"[{'ForeName': 'Hsing-Yuan', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Ding-Yang', 'Initials': 'DY', 'LastName': 'Hsu', 'Affiliation': 'Department of Industrial Design, Ming Chi University of Tchnology, 84 Gungjuan Rd., Taishan Dist., New Taipei City 243303, Taiwan.'}, {'ForeName': 'Hui-Mei', 'Initials': 'HM', 'LastName': 'Han', 'Affiliation': 'Department of Nursing, Linkou Chang Gung Memorial Hospital, No. 5, Fuxing St., Guishan Dist., Taoyuan City 333423, Taiwan.'}, {'ForeName': 'I-Teng', 'Initials': 'IT', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Nai-Hung', 'Initials': 'NH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Chin-Yen', 'Initials': 'CY', 'LastName': 'Han', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Sheau-Ming', 'Initials': 'SM', 'LastName': 'Wu', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Hsiu-Fang', 'Initials': 'HF', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Ding-Hau', 'Initials': 'DH', 'LastName': 'Huang', 'Affiliation': 'Institute of Creative Design and Management, National Taipei University of Business, No. 100, Sec. 1, Fulong Rd., Pingzhen Dist., Taoyuan City 324022, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19105875']
1272,35627403,Effectiveness of a Brief Lifestyle Intervention in the Prenatal Care Setting to Prevent Excessive Gestational Weight Gain and Improve Maternal and Infant Health Outcomes.,"Research on perinatal programming shows that excessive gestational weight gain (GWG) increases the risk of overweight and obesity later in a child's life and contributes to maternal weight retention and elevated risks of obstetrical complications. This study examined the effectiveness of a brief lifestyle intervention in the prenatal care setting, compared to routine prenatal care, in preventing excessive GWG as well as adverse maternal and infant health outcomes. The GeMuKi study was designed as a cluster RCT using a hybrid effectiveness implementation design and was conducted in the prenatal care setting in Germany. A total of 1466 pregnant women were recruited. Pregnant women in intervention regions received up to six brief counseling sessions on lifestyle topics (e.g., physical activity, nutrition, drug use). Data on GWG and maternal and infant outcomes were entered into a digital data platform by the respective healthcare providers. The intervention resulted in a significant reduction in the proportion of women with excessive GWG (OR = 0.76, 95% CI (0.60 to 0.96),  p  = 0.024). Gestational weight gain in the intervention group was reduced by 1 kg (95% CI (-1.56 to -0.38),  p  &lt; 0.001). No evidence of intervention effects on pregnancy, birth, or neonatal outcomes was found.",2022,"The intervention resulted in a significant reduction in the proportion of women with excessive GWG (OR = 0.76, 95% CI (0.60 to 0.96),  p  = 0.024).","['prenatal care setting in Germany', 'Pregnant women in intervention regions', '1466 pregnant women were recruited']","['six brief counseling sessions', 'brief lifestyle intervention', 'Brief Lifestyle Intervention']","['adverse maternal and infant health outcomes', 'pregnancy, birth, or neonatal outcomes', 'proportion of women with excessive GWG', 'Excessive Gestational Weight Gain and Improve Maternal and Infant Health Outcomes', 'Gestational weight gain']","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",1466.0,0.0361787,"The intervention resulted in a significant reduction in the proportion of women with excessive GWG (OR = 0.76, 95% CI (0.60 to 0.96),  p  = 0.024).","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Krebs', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lorenz', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Nawabi', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Alayli', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Stock', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19105863']
1273,35627877,Neuroendocrine Response and State Anxiety Due to Psychosocial Stress Decrease after a Training with Subject's Own (but Not Another) Virtual Body: An RCT Study.,"Previous research involving healthy participants has reported that seeing a moving virtual body from the first person perspective induces the illusion of ownership and agency over that virtual body. When a person is sitting and the virtual body runs, it is possible to measure physiological, behavioral and cognitive reactions that are comparable to those that occur during actual movement. Capitalizing on this evidence, we hypothesized that virtual training could also induce neuroendocrine effects that prompt a decreased psychosocial stress response, as occurs after physical training. While sitting, 26 healthy young adults watched a virtual avatar running for 30 min from the first person perspective (experimental group), while another 26 participants watched the virtual body from the third person perspective (control group). We found a decreased salivary alpha-amylase concentration (a biomarker for the stress response) after the virtual training among the experimental group only, as well as a decreased subjective feeling of state anxiety (but no difference in heart rate). We argue that the virtual illusion of a moving body from the first person perspective can initiate a cascade of events, from the perception of the visual illusion to physiological activation that triggers other biological effects, such as the neuroendocrine stress response.",2022,"We found a decreased salivary alpha-amylase concentration (a biomarker for the stress response) after the virtual training among the experimental group only, as well as a decreased subjective feeling of state anxiety (but no difference in heart rate).","['26 healthy young adults watched a', 'healthy participants']","['virtual avatar running for 30 min from the first person perspective (experimental group), while another 26 participants watched the virtual body from the third person perspective (control group']","['subjective feeling of state anxiety', 'salivary alpha-amylase concentration', 'Neuroendocrine Response and State Anxiety', 'psychosocial stress response', 'heart rate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",26.0,0.00383765,"We found a decreased salivary alpha-amylase concentration (a biomarker for the stress response) after the virtual training among the experimental group only, as well as a decreased subjective feeling of state anxiety (but no difference in heart rate).","[{'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Burin', 'Affiliation': 'Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Cavanna', 'Affiliation': 'Smart Aging Research Center (SARC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rabellino', 'Affiliation': 'Department of Psychiatry, Western University, 550 Wellington Rd., London, ON N6C 5J1, Canada.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Kotozaki', 'Affiliation': 'Division of Clinical Research and Epidemiology, Iwate Tohoku Medical Megabank Organization, Iwate Medical University, 1-1-1, Idaidori, Yahaba, Iwate, Morioka 028-3694, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph19106340']
1274,35627867,The Effect of Physical Exercise on Fundamental Movement Skills and Physical Fitness among Preschool Children: Study Protocol for a Cluster-Randomized Controlled Trial.,"Background : Evidence shows that physical exercise promotes preschoolers' fundamental movement skills (FMSs) and physical fitness (PF). However, studies that assess the effectiveness of different types of physical exercise interventions to improve FMSs and PF in preschool children remain scarce. To explore and compare the effectiveness of different physical exercise on FMSs and PF, interventions comprising ball games (BGs), rhythm activities (RAs), basic movements (BMs), and a combination of all related activities (multiple activities, MAs) will be conducted among preschoolers.  Methods : A single-blind, five-arm, cluster-randomized trial will be conducted in kindergarten in Shanghai, China. In total, 300 healthy preschoolers, aged 4 to 5 years, will be randomized to four intervention groups (BG, RA, BM, or MA) and one control group (unorganized physical activities). Four intervention groups will receive three 30-min lessons weekly for 16 weeks. At the baseline, the end of the 16-week intervention, and the 6-month follow-up after the end of the intervention, the primary outcomes (FMSs and PF) and physical activity (PA), and sociodemographic and anthropometric data will be assessed.  Discussion : This study will provide vital information regarding the effect of different physical exercise interventions on preschool children's FMSs and PF, PA, and the potential interactions between these domains. The most effective intervention strategy can be generalized to kindergarten and other preschool educational institutions in practice to promote preschoolers' development of FMSs and PF.  Conclusions : This study protocol aims to provide a method to solve the problem of ""how to arrange physical exercise and which kind of physical exercise program can promote FMS and PF better in preschool children"".",2022,"To explore and compare the effectiveness of different physical exercise on FMSs and PF, interventions comprising ball games (BGs), rhythm activities (RAs), basic movements (BMs), and a combination of all related activities (multiple activities, MAs) will be conducted among preschoolers.  ","['kindergarten in Shanghai, China', 'Discussion ', '300 healthy preschoolers, aged 4 to 5 years', ""preschool children's"", 'preschool children', 'Preschool Children']","['physical exercise', 'Physical Exercise', 'physical exercise interventions', ' ', 'physical exercise program']","['FMSs and PF, interventions comprising ball games (BGs), rhythm activities (RAs), basic movements (BMs), and a combination of all related activities (multiple activities, MAs', 'primary outcomes (FMSs and PF) and physical activity (PA), and sociodemographic and anthropometric data will be assessed', ""preschoolers' fundamental movement skills (FMSs) and physical fitness (PF"", 'Fundamental Movement Skills and Physical Fitness']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]",300.0,0.025744,"To explore and compare the effectiveness of different physical exercise on FMSs and PF, interventions comprising ball games (BGs), rhythm activities (RAs), basic movements (BMs), and a combination of all related activities (multiple activities, MAs) will be conducted among preschoolers.  ","[{'ForeName': 'Guangxu', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yahua', 'Initials': 'Y', 'LastName': 'Zi', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Chener', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai 200438, China.'}]",International journal of environmental research and public health,['10.3390/ijerph19106331']
1275,35627863,Self-Serving Dishonesty Partially Substitutes Fairness in Motivating Cooperation When People Are Treated Fairly.,"Fairness is a key expectation in social interactions. Its violation leads to adverse reactions, including non-cooperation and dishonesty. The present study aimed to examine how (1) fair (unfair) treatment may drive cooperation (defection) and honesty (self-serving dishonesty), (2) dishonesty primes further moral disengagement and reduced cooperation, and (3) dishonesty weakens (substitutes) the effect of fairness on cooperation. The prisoner's dilemma (Experiment 1 and 2) and die-rolling task (Experiment 2) were employed for capturing cooperation and dishonest behaviors, respectively. To manipulate perceived unfairness, participants were randomly assigned to play the prisoner's dilemma game, where players either choose more cooperation (fair condition) or defection (unfair condition). Results of Experiment 1 ( n  = 102) suggested that participants perceive higher unfairness and behave less cooperatively when the other player primarily chooses defection. Results of Exp. 2 ( n  = 240) (a) confirmed Exp. 1 results, (b) showed that players in the unfair condition also show more self-serving dishonest behavior, and (c) that dishonest behavior weakens the effect of fairness on cooperation. Together, these results extended previous work by highlighting the self-serving lies when the opponent is fair trigger higher cooperation, presumably as a means to alleviate self-reflective moral emotions or restore justice.",2022,"The prisoner's dilemma (Experiment 1 and 2) and die-rolling task (Experiment 2) were employed for capturing cooperation and dishonest behaviors, respectively.",['2 ( n  = 240'],"[""prisoner's dilemma game, where players either choose more cooperation (fair condition) or defection (unfair condition"", 'Self-Serving Dishonesty']",[],"[{'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0033166', 'cui_str': ""Prisoner's Dilemma""}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",[],,0.0467381,"The prisoner's dilemma (Experiment 1 and 2) and die-rolling task (Experiment 2) were employed for capturing cooperation and dishonest behaviors, respectively.","[{'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'MOE Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Turel', 'Affiliation': 'Computing Information Systems, The University of Melbourne, Parkville, VIC 3010, Australia.'}, {'ForeName': 'Shuyue', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Guangxi Colleges and Universities Key Laboratory of Cognitive Neuroscience and Applied Psychology, Faculty of Education, Guangxi Normal University, Guilin 541006, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'MOE Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing 400715, China.'}]",International journal of environmental research and public health,['10.3390/ijerph19106326']
1276,35635266,Testing temporal frames of colorectal cancer risks: evidence from randomized online experiments.,"Low perceived risk of is associated with a low probability of engaging in risk preventive behaviours. Temporal framing has been suggested to make the risk seem higher, as narrower time frames appear to increase perceived risk and intentions to engage in risk-preventive behaviours. In two online experiments, we tested how manipulating risk information about colorectal cancer (CRC) influenced risk perception and preventive behaviours. 902 men and women aged 45-54 were recruited from an English online panel. Study 1 (N = 132) investigated how communicating CRC mortality instead of incidence rates influences risk perception, using both yearly and daily frames. In study 2 (N = 770), CRC incidence was described as occurring  yearly, daily  or  hourly . The primary outcome measures were risk perception, intention to engage in preventive behaviours and whether participants chose to read information about ways to reduce CRC risk or skip it to finish the survey. Study 1 did not find a difference in intentions based on information about the risk of developing vs the risk of dying of CRC. Study 2 found that, while communicating CRC incidence occurring as  every day  increased information-seeking behaviour compared to  every year  and  every hour  (57.4% vs 45.9% vs 45.6%, p = 0.012), individuals in the  daily  condition were less likely to get all comprehension questions right (69.9% vs 78.2% vs 85.0%, respectively, p = 0.015). Temporal framing had no impact on perceived risk or intentions to engage in risk-reducing behaviours. While manipulating risk information in terms of temporal framing did not increase perceived risk, it may influence people's decision to engage with the information in the first place.",2022,"The primary outcome measures were risk perception, intention to engage in preventive behaviours and whether participants chose to read information about ways to reduce CRC risk or skip it to finish the survey.",['902 men and women aged 45-54 were recruited from an English online panel'],[],"['perceived risk or intentions to engage in risk-reducing behaviours', 'risk perception and preventive behaviours', 'information-seeking behaviour', 'risk perception, intention to engage in preventive behaviours and whether participants chose to read information about ways to reduce CRC risk or skip it to finish the survey', 'CRC incidence']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",902.0,0.101934,"The primary outcome measures were risk perception, intention to engage in preventive behaviours and whether participants chose to read information about ways to reduce CRC risk or skip it to finish the survey.","[{'ForeName': 'Sandro T', 'Initials': 'ST', 'LastName': 'Stoffel', 'Affiliation': 'European Commission, Joint Research Centre (JRC), Ispra, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Hvalica Coldwell', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Herrmann', 'Affiliation': 'European Commission, Joint Research Centre (JRC), Ispra, Italy.'}]","Psychology, health & medicine",['10.1080/13548506.2022.2061716']
1277,35636734,"An integrated mindfulness meditation and acceptance and commitment therapy intervention for chronic pain: Rationale, design, and methodology of a pilot randomized controlled trial of Acting with Mindfulness for Pain (AMP).","Acceptance and commitment therapy (ACT) is an evidence-based psychosocial intervention for chronic pain; however, in its present form ACT produces modest improvements in function and is no more effective than cognitive behavioral therapy (CBT), the current gold standard. This protocol paper describes the Acting with Mindfulness for Pain (AMP) protocol, which emphasizes and integrates formal mindfulness meditation practice within an ACT-based approach. This paper presents the rationale, design and methodology of an ongoing pilot randomized controlled trial (RCT) comparing AMP to CBT among Veterans with chronic pain (N = 86). Specifically, we argue that formal meditation practice is a necessary treatment component that directly targets key ACT processes which will help facilitate large treatment effects on function (e.g., general activity, social relationships, life enjoyment) among individuals with chronic pain. This study will be the first to consider formal mindfulness meditation practice as a principal treatment ingredient in the context of ACT for chronic pain. The purpose of this trial is to evaluate the feasibility of recruitment and collection of measures, and to examine preliminary treatment effects to determine the appropriateness of a subsequent full-scale RCT. This study will also explore within and between group change on primary and secondary outcomes including pain interference, pain acceptance, trait mindfulness, pain catastrophizing, values-based living, quality of life, practice adherence, and objective measures of physical activity. This study will help delineate the role of formal mindfulness practice within an ACT-based approach for chronic pain and provide preliminary data for a future fully powered RCT.",2022,"This study will also explore within and between group change on primary and secondary outcomes including pain interference, pain acceptance, trait mindfulness, pain catastrophizing, values-based living, quality of life, practice adherence, and objective measures of physical activity.","['chronic pain', 'Veterans with chronic pain (N\u202f=\u202f86', 'individuals with chronic pain']","['Acceptance and commitment therapy (ACT', 'integrated mindfulness meditation and acceptance and commitment therapy intervention']","['pain interference, pain acceptance, trait mindfulness, pain catastrophizing, values-based living, quality of life, practice adherence, and objective measures of physical activity']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.118568,"This study will also explore within and between group change on primary and secondary outcomes including pain interference, pain acceptance, trait mindfulness, pain catastrophizing, values-based living, quality of life, practice adherence, and objective measures of physical activity.","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Herbert', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, CA, USA; VA Center of Excellence for Stress and Mental Health, San Diego, CA, USA. Electronic address: Matthew.Herbert2@va.gov.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Tynan', 'Affiliation': 'San Diego State University/University of California San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Ariel J', 'Initials': 'AJ', 'LastName': 'Lang', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA; VA Center of Excellence for Stress and Mental Health, San Diego, CA, USA; Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, CA, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Backhaus', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Casmar', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Golshan', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Afari', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California, San Diego, CA, USA; VA Center of Excellence for Stress and Mental Health, San Diego, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106809']
1278,35636733,COMbined Exercise Trial (COMET) to improve cognition in older adults: Rationale and methods.,"Substantial evidence suggests physical exercise may sustain cognitive function and perhaps prevent Alzheimer's Disease (1, 2). Current public health recommendations call for older adults to do at least 150 min a week of aerobic exercise (e.g. walking) and twice a week resistance exercise (e.g. weight lifting) for physical health. Yet, much remains unknown about how these exercise modalities support brain health independently or in combination. The COMbined Exercise Trial (COMET) is designed to test the combined and independent effects of aerobic and resistance training specifically focusing on exercise-related changes in 1) cognitive performance, 2) regional brain volume, 3) physical function, and 4) blood-based factors. To explore these questions, we will enroll 280 cognitively normal older adults, age 65-80 years, into a 52-week community-based exercise program. Participants will be randomized into one of four arms: 1) flexibility/toning- control 2) 150 min of aerobic exercise only, 3) progressive resistance training only, or 4) combined aerobic and progressive resistance training. Outcomes assessed include a comprehensive cognitive battery, blood biomarkers, brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and battery of psychosocial questionnaires is assessed at baseline, 6 and 12-months. COMET will provide rigorous randomized controlled trial data to understand the effects of the most common exercise modalities, and their combination (i.e., the standard public health recommendation), on brain health.",2022,"Participants will be randomized into one of four arms: 1) flexibility/toning- control 2) 150 min of aerobic exercise only, 3) progressive resistance training only, or 4) combined aerobic and progressive resistance training.","['280 cognitively normal older adults, age 65-80\u202fyears, into a 52-week community-based exercise program', 'older adults']","['flexibility/toning- control 2) 150\u202fmin of aerobic exercise only, 3) progressive resistance training only, or 4) combined aerobic and progressive resistance training', 'COMbined Exercise Trial (COMET', 'aerobic exercise (e.g. walking) and twice a week resistance exercise']","['exercise-related changes in 1) cognitive performance, 2) regional brain volume, 3) physical function, and 4) blood-based factors', 'comprehensive cognitive battery, blood biomarkers, brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and battery of psychosocial questionnaires']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",280.0,0.0458289,"Participants will be randomized into one of four arms: 1) flexibility/toning- control 2) 150 min of aerobic exercise only, 3) progressive resistance training only, or 4) combined aerobic and progressive resistance training.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Szabo-Reed', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA; Department of Internal Medicine, Division of Physical Activity and Weight Management, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: aszabo2@ku.edu.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Clutton', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA.""}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'White', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Van Sciver', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA.""}, {'ForeName': 'Dreu', 'Initials': 'D', 'LastName': 'White', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA.""}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, USA; Hoglund Biomedical Imaging Center, University of Kansas Medical Center, Kanas City, KS, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lepping', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA; Hoglund Biomedical Imaging Center, University of Kansas Medical Center, Kanas City, KS, USA.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Shaw', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.""}, {'ForeName': 'Jaime Perales', 'Initials': 'JP', 'LastName': 'Puchalt', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Montgomery', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mahnken', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, Division of Physical Activity and Weight Management, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.""}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ""KU Alzheimer's Disease Research Center, Fairway, KS, USA; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2022.106805']
1279,35636696,Randomized Phase 2 Study of Osimertinib Plus Bevacizumab Versus Osimertinib for Untreated Patients With Nonsquamous NSCLC Harboring EGFR Mutations: WJOG9717L Study.,"INTRODUCTION


To evaluate the efficacy and safety of osimertinib plus bevacizumab for previously untreated patients with advanced nonsquamous NSCLC harboring EGFR-sensitizing mutations.
METHODS


We conducted a randomized, open-label, phase 2 study at 21 institutions in Japan. Previously untreated patients with advanced nonsquamous NSCLC harboring EGFR-sensitizing mutations received either osimertinib (80 mg, daily) plus bevacizumab (15 mg/kg, every 3 wk) or osimertinib monotherapy, and were stratified according to sex, stage, and EGFR mutation status. The primary end point was progression-free survival (PFS) in the intention-to-treat population, assessed by means of blinded, independent central radiologic review.
RESULTS


Between January 2018 and September 2018, a total of 122 patients were enrolled (osimertinib + bevacizumab arm, 61 patients; osimertinib monotherapy arm, 61 patients). At a median follow-up duration of 19.8 months, the median PFS was 22.1 months for osimertinib plus bevacizumab and 20.2 months for osimertinib monotherapy, with a hazard ratio of 0.862 (60% confidence interval: 0.700-1.060, 95% confidence interval: 0.531-1.397, one-sided stratified log-rank p = 0.213). Adverse events of grade 3 or worse were observed in 34 patients (56%) in the osimertinib plus bevacizumab arm and 29 (48%) in the osimertinib monotherapy arm. In addition, two (3%) and 11 patients (18%) experienced any grade pneumonitis, respectively, and grade 3 pneumonitis was observed in one patient (2%) in each arm.
CONCLUSIONS


This study failed to exhibit the efficacy of osimertinib plus bevacizumab for improving the PFS among patients with nonsquamous NSCLC harboring EGFR mutations as first-line treatment.",2022,"At a median follow-up duration of 19.8 months, the median PFS was 22.1 months for osimertinib plus bevacizumab and 20.2 months for Osimertinib monotherapy, with a hazard ratio of 0.862 (60% confidence interval, 0.700-1.060; 95% confidence interval, 0.531-1.397; one-sided stratified log-rank p=0.213).","['21 institutions in Japan', 'Previously untreated patients with advanced non-squamous NSCLC harboring EGFR sensitizing mutations', 'untreated patients with non-squamous non-small cell lung cancer harboring EGFR mutations', 'Between January 2018 and September 2018, 122 patients were enrolled (osimertinib plus bevacizumab arm, 61 patients; osimertinib monotherapy arm, 61 patients', 'previously untreated patients with advanced non-squamous NSCLC harboring EGFR sensitizing mutations', 'patients with non-squamous NSCLC harboring EGFR mutations as first-line treatment']","['osimertinib plus bevacizumab', 'osimertinib', 'bevacizumab']","['efficacy and safety', 'grade pneumonitis', 'progression-free survival (PFS', 'median PFS', 'grade 3 pneumonitis']","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",122.0,0.138681,"At a median follow-up duration of 19.8 months, the median PFS was 22.1 months for osimertinib plus bevacizumab and 20.2 months for Osimertinib monotherapy, with a hazard ratio of 0.862 (60% confidence interval, 0.700-1.060; 95% confidence interval, 0.531-1.397; one-sided stratified log-rank p=0.213).","[{'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kenmotsu', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan. Electronic address: h.kenmotsu@scchr.jp.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Wakuda', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Mori', 'Affiliation': 'Clinical Research Center, Shizuoka Cancer Center, Nagaizumi, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kirita', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Yoneshima', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Nishino', 'Affiliation': 'Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Teraoka', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Takehito', 'Initials': 'T', 'LastName': 'Shukuya', 'Affiliation': 'Department of Respiratory Medicine, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Masuda', 'Affiliation': 'Department of Respiratory Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Toyozawa', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Miura', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Fujimoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan; Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Hyogo, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2022.05.006']
1280,35642688,The effect of empowerment counseling on stress and self-esteem of mothers with hospitalized premature infants.,"BACKGROUND


This study aimed to investigate the effect of counselling on stress and self-esteem of mothers with hospitalized premature infants.
MATERIALS AND METHODS


This parallel randomized clinical trial was conducted on 80 primigravida mothers aged 18-40 years, gestational age of 28-34 weeks in 2021 in Iran. The women were randomly assigned to two groups by blocked randomization. The data were collected using a demographic information questionnaire, Paternal Stress Scale and Rosenberg self-esteem questionnaire. Individual counselling based on the GATHER model was carried out within two consecutive weeks in four sessions. Data were analyzed with SPSS 24.
RESULTS


There was no significant difference between the two groups in demographic variables, stress, and self-esteem before the intervention (P>0.05). There was a substantial difference in the mean score of self - esteem 9.52±3.22 and 16.75±6.39 (P<0.001), stress 154.65±32.15and 61±10.98 (P<0.001) and different dimensions of stress between the control and intervention groups after the intervention. The most significant reduction occurred in the dimension of appearance and behaviour of the infant (cohen d=3.146).
CONCLUSIONS


The results show counselling with an empowerment approach based on the GATHER model is effective in reducing stress and increasing self-esteem of mothers of premature infants admitted to the intensive care unit.",2022,"There was no significant difference between the two groups in demographic variables, stress, and self-esteem before the intervention (P>0.05).","['80 primigravida mothers aged 18-40 years, gestational age of 28-34 weeks in 2021 in Iran', 'mothers with hospitalized premature infants', 'mothers of premature infants admitted to the intensive care unit']",['empowerment counseling'],"['stress and self-esteem', 'demographic information questionnaire, Paternal Stress Scale and Rosenberg self-esteem questionnaire', 'demographic variables, stress, and self-esteem', 'mean score of self - esteem']","[{'cui': 'C0860096', 'cui_str': 'Primigravida'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0337493', 'cui_str': 'Paternal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0412163,"There was no significant difference between the two groups in demographic variables, stress, and self-esteem before the intervention (P>0.05).","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'Department of Mother and Child Health, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Rafat', 'Initials': 'R', 'LastName': 'Bakht', 'Affiliation': 'Department of Mother and Child Health, Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Tapak', 'Affiliation': 'Department of Biostatistics, School of Public Health ND Modeling of Noncommunicable Diseases Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mansoureh', 'Initials': 'M', 'LastName': 'Refaei', 'Affiliation': 'Department of Mother and Child Health, Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Basiri', 'Affiliation': 'Department of Pediatrics, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of reproductive and infant psychology,['10.1080/02646838.2022.2081674']
1281,35642684,The effect of environmental noise isolation on bronchiolitis severity in hospitalised children.,"AIM


Bronchiolitis is an infectious disease, with no effective treatment. Music and Mozart's works specifically are known to have a positive effect on physiological parameters, while noise is considered harmful. We aim to evaluate the short-term effect of environmental noise detachment and/or music listening on the course of bronchiolitis in hospitalised children.
METHODS


This is a prospective, double-blinded randomised controlled trial. Patients were divided into three intervention groups: 1-Mozart's Sonata, 2-instrumental music, 3-silence. Music was heard via media players and soundproof headphones. Disease severity was evaluated before and after intervention using the Modified Tal score.
RESULTS


Seventy music sessions were included in the analysis (Mozart n = 23, instrumental n = 22, silence n = 25). A one-point drop in the average bronchiolitis severity score was observed in all three groups from 7.1 (CI 95%, 5 to 9.2) to 6.1 (CI 95%, 4.3 to 7.9), p < 0.001. No significant difference was found between the three groups with respect to change in the severity score before and after the intervention.
CONCLUSION


Isolation from disturbing sounds heard in paediatric departments could be considered a simple non-invasive intervention in children hospitalised with bronchiolitis. Further studies are warranted to evaluate long-term effects of this intervention and the specific effect of music.",2022,"No significant difference was found between the three groups with respect to change in the severity score before and after the intervention.
","['Hospitalized Children', 'Seventy music sessions were included in the analysis (Mozart n=23, instrumental n=22, silence n=25', 'hospitalized children', 'children hospitalized with bronchiolitis']","['environmental noise detachment and/or music listening', ""1-Mozart'a Sonata, 2-instrumental music, 3-silence"", 'environmental Noise Isolation']","['Disease severity', 'average bronchiolitis severity score', 'severity score']","[{'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0876170', 'cui_str': 'Sonata'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",,0.0602224,"No significant difference was found between the three groups with respect to change in the severity score before and after the intervention.
","[{'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Ziv', 'Affiliation': ""Department of Pediatrics C, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Zagon-Rogel', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yehezkel', 'Initials': 'Y', 'LastName': 'Waisman', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Rom', 'Affiliation': ""Department of Pediatrics C, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Attias', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Krause', 'Affiliation': ""Department of Pediatrics C, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.16437']
1282,35642570,"Efficacy and safety of PavéDerm J-Fill for nasolabial folds: A phase III randomized, blinded, prospective, and split-faced head-to-head trial.",,2022,,['Nasolabial Folds'],['PavéDerm J-Fill'],['Efficacy and Safety'],"[{'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0405386,,"[{'ForeName': 'Sheng-Hsiang', 'Initials': 'SH', 'LastName': 'Ma', 'Affiliation': 'Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsun', 'Initials': 'YH', 'LastName': 'Wei', 'Affiliation': 'Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ding-Dar', 'Initials': 'DD', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yun-Ting', 'Initials': 'YT', 'LastName': 'Chang', 'Affiliation': 'Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Chiang', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan.'}]",Dermatologic therapy,['10.1111/dth.15612']
1283,35644993,Cost-effectiveness of an exercise-based cardiovascular rehabilitation program in patients with chronic Chagas cardiomyopathy in Brazil: An analysis from the PEACH study.,"OBJECTIVES


The present study aimed to perform a cost-effectiveness analysis of an exercise-based cardiovascular rehabilitation (CR) program in patients with chronic Chagas cardiomyopathy (CCC).
METHODS


Cost-effectiveness analysis alongside a randomised clinical trial evaluating the effects of a 6-month exercise-based CR program. The intervention group underwent 3 weekly exercise sessions. The variation of peak oxygen consumption (VO 2peak  ) was used as a measurement of clinical outcome. Cost information from all healthcare expenses (examinations, healthcare visits, medication and hospitalisation) were obtained from the medical records in Brazilian reais (R$) and transformed into dollars using the purchasing power parity ($PPP). The longitudinal costs variation was evaluated through linear mixed models, represented by β coefficient, adjusted for the baseline values of the dependent variable. The cost-effectiveness evaluation was determined through an incremental cost-effectiveness ratio using the HEABS package (Stata 15.0).
RESULTS


The intervention group presented higher costs with healthcare visits (β = +3317.3; p < 0.001), hospitalisation (β = +2810.4; p = 0.02) and total cost (β = +6407.9; p < 0.001) after 3 months of follow-up. Costs related to healthcare visits (β = +2455.8; p < 0.001) and total cost (β = +4711.4; p < 0.001) remained higher in the intervention group after 6 months. The CR program showed an incremental cost-effectiveness ratio (ICER) of $PPP 1874.3 for each increase of 1.0 ml kg -1   min -1  of VO 2peak  .
CONCLUSIONS


The CR program can be considered a cost-effective alternative and should be included as an intervention strategy in the care of patients with CCC.",2022,"Costs related to healthcare visits (β = +2,455.8; p<0.001) and total cost (β = +4,711.4; p<0.001) remained higher in the intervention group after six months.","['patients with chronic Chagas cardiomyopathy (CCC', 'Patients with Chronic Chagas Cardiomyopathy in Brazil', 'patients with CCC']","['6-month exercise-based CR program', 'exercise-based cardiovascular rehabilitation (CR) program', 'Exercise-Based Cardiovascular Rehabilitation Program', 'exercise sessions']","['Cost-effectiveness', 'higher costs with healthcare visits', 'total cost', 'incremental cost-effectiveness ratio (ICER', 'cost-effectiveness evaluation', 'peak oxygen consumption (VO 2peak  ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007930', 'cui_str': ""Chagas' disease with heart involvement""}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0700431', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",,0.00953435,"Costs related to healthcare visits (β = +2,455.8; p<0.001) and total cost (β = +4,711.4; p<0.001) remained higher in the intervention group after six months.","[{'ForeName': 'Valeria Alencar Linhares', 'Initials': 'VAL', 'LastName': 'Simões', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fernanda de Souza Nogueira Sardinha', 'Initials': 'FSNS', 'LastName': 'Mendes', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alexandre Monken', 'Initials': 'AM', 'LastName': 'Avellar', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gilberto Marcelo Sperandio', 'Initials': 'GMS', 'LastName': 'da Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fernanda Martins', 'Initials': 'FM', 'LastName': 'Carneiro', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Paula Simplício', 'Initials': 'PS', 'LastName': 'Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Mazzoli-Rocha', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rudson Santos', 'Initials': 'RS', 'LastName': 'Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marcelo Carvalho', 'Initials': 'MC', 'LastName': 'Vieira', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Celson Júnio do Nascimento', 'Initials': 'CJDN', 'LastName': 'Costa', 'Affiliation': 'Department of Research and Education, National Institute of Cardiology, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Sousa', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Claudia Maria Valete', 'Initials': 'CMV', 'LastName': 'Rosalino', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Patrícia Fernandes da Silva', 'Initials': 'PFDS', 'LastName': 'Nobre', 'Affiliation': 'National Institute Quality Control in Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marcelo Teixeira', 'Initials': 'MT', 'LastName': 'de Holanda', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Henrique Silveira', 'Initials': 'HS', 'LastName': 'Costa', 'Affiliation': 'Department of Physical Therapy, Faculty of Healthy and Biological Sciences, Federal University of Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Brazil.'}, {'ForeName': 'Roberto Magalhães', 'Initials': 'RM', 'LastName': 'Saraiva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alejandro Marcel', 'Initials': 'AM', 'LastName': 'Hasslocher-Moreno', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Castro', 'Affiliation': 'Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mauro Felippe Felix', 'Initials': 'MFF', 'LastName': 'Mediano', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13784']
1284,35568940,A novel nomogram for predicting cancer-specific survival in women with uterine sarcoma: a large population-based study.,"BACKGROUND


Uterine sarcoma (US) is a rare malignant uterine tumor with aggressive behavior and rapid progression. The purpose of this study was to constructa comprehensive nomogram to predict cancer-specific survival (CSS) of patients with US-based on the Surveillance, Epidemiology, and End Results (SEER) database.
METHODS


A retrospective population-based study was conducted using data from patients with US between 2010 and 2015 from the SEER database. They were randomly divided into a training cohort and a validation cohort ata 7-to-3 ratio. Multivariate Cox analysis was performed to identify independent prognostic factors. Subsequently, a nomogram was established to predict patient CSS. The discrimination and calibration of the nomogram were evaluated by the concordance index (C-index) and the area under the curve (AUC). Finally, net reclassification improvement (NRI), integrated discrimination improvement (IDI), calibration plotting, and decision-curve analysis (DCA) were used to evaluate the benefits of the new prediction model.
RESULTS


A total of 3861 patients with US were included in our study. As revealed in multivariate Cox analysis, age at diagnosis, race, marital status, insurance record, tumor size, pathology grade, histological type, SEER stage, AJCC stage, surgery status, radiotherapy status, and chemotherapy status were found to be independent prognostic factors. In our nomogram, pathology grade had strongest correlation with CSS, followed by age at diagnosis and surgery status. Compared to the AJCC staging system, the new nomogram showed better predictive discrimination with a higher C-index in the training and validation cohorts (0.796 and 0.767 vs. 0.706 and 0.713, respectively). Furthermore, the AUC value, calibration plotting, NRI, IDI, and DCA also demonstrated better performance than the traditional system.
CONCLUSION


Our study validated the first comprehensive nomogram for US, which could provide more accurate and individualized survival predictions for US patients in clinical practice.",2022,"Compared to the AJCC staging system, the new nomogram showed better predictive discrimination with a higher C-index in the training and validation cohorts (0.796 and 0.767 vs. 0.706 and 0.713, respectively).","['patients with US-based on the Surveillance, Epidemiology, and End Results (SEER) database', 'patients with US between 2010 and 2015 from the SEER database', '3861 patients with US were included in our study', 'women with uterine sarcoma']",[],"['cancer-specific survival', 'net reclassification improvement (NRI), integrated discrimination improvement (IDI), calibration plotting, and decision-curve analysis (DCA', 'AUC value, calibration plotting, NRI, IDI, and DCA', 'cancer-specific survival (CSS', 'concordance index (C-index) and the area under the curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338113', 'cui_str': 'Sarcoma of uterus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",3861.0,0.0914355,"Compared to the AJCC staging system, the new nomogram showed better predictive discrimination with a higher C-index in the training and validation cohorts (0.796 and 0.767 vs. 0.706 and 0.713, respectively).","[{'ForeName': 'Yuan-Jie', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': ""Department of Human Anatomy, Histology and Embryology, School of Basic Medical Sciences, Xi'an Jiao Tong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Hai-Rong', 'Initials': 'HR', 'LastName': 'He', 'Affiliation': ""Department of Clinical Research Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Wang', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Yue-Ling', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': ""Department of Gynecology and Obstetrics, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, Shaanxi, China. jijing08@xjtu.edu.cn.""}]",BMC women's health,['10.1186/s12905-022-01739-5']
1285,35570288,Health-related quality of life and associated factors in Chinese menstrual migraine patients: a cross-sectional study.,"BACKGROUND


Menstrual migraine is a particular form of migraine with a significant impact on the quality of life for women afflicted. Presently, no study has reported the quality of life in menstrual migraine patients. This work aims to assess the health-related quality of life and identify its associated factors among Chinese menstrual migraine patients.
METHODS


The cross-sectional study group consisted of 109 patients with menstrual migraine, and the control group consisted of 397 female patients with non-menstrual migraine. In total, 506 patients completed questionnaires for demographic and clinical information, the Self-rating Idea of Suicide Scale, the Hamilton Depression Scale, the Hamilton Anxiety Scale, the Headache Impact Test-6, the Perceived Social Support Scale, the Pittsburgh Sleep Quality Index. Health-related quality of life was measured using the 36-Item Short Form Survey.
RESULTS


Compared with non-menstrual migraine patients, five dimensions of health-related quality of life were all found to be significantly impaired in menstrual migraine patients. Headache frequency (ß = - 0.218, P = 0.014), the impact of headache on daily life (ß = - 0.270, P = 0.002), depression symptoms (ß = - 0.345, P < 0.001) were significantly associated with physical component summary, depression symptoms (ß = - 0.379, P < 0.001), social support (ß = 0.270, P < 0.001), suicidal ideation (ß = - 0.344, P < 0.001) were closely related to mental component summary.
CONCLUSION


Menstrual migraine patients had a significantly poorer health-related quality of life in many domains than non-menstrual migraine patients. Headache frequency, the impact of headache on daily life, depression symptoms, social support, and suicidal ideation were significantly associated with health-related quality of life in menstrual migraine patients.
TRIAL REGISTRATION


ChiCTR1800014343. This study was registered prospectively on 7 January 2018 at Chinese Clinical Trial registry. http://www.chictr.org.cn/showproj.aspx?proj=24526.",2022,"CONCLUSION


Menstrual migraine patients had a significantly poorer health-related quality of life in many domains than non-menstrual migraine patients.","['506 patients completed', 'menstrual migraine patients', '7 January 2018 at Chinese Clinical Trial registry', '109 patients with menstrual migraine, and the control group consisted of 397 female patients with non-menstrual migraine', 'Chinese menstrual migraine patients']",[],"['depression symptoms', 'health-related quality of life', 'suicidal ideation', 'Health-related quality of life', 'questionnaires for demographic and clinical information, the Self-rating Idea of Suicide Scale, the Hamilton Depression Scale, the Hamilton Anxiety Scale, the Headache Impact Test-6, the Perceived Social Support Scale, the Pittsburgh Sleep Quality Index', 'quality of life', 'Headache frequency', 'Headache frequency, the impact of headache on daily life, depression symptoms, social support, and suicidal ideation', 'physical component summary, depression symptoms', 'social support', 'impact of headache on daily life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0269226', 'cui_str': 'Menstrual migraine'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",109.0,0.0341567,"CONCLUSION


Menstrual migraine patients had a significantly poorer health-related quality of life in many domains than non-menstrual migraine patients.","[{'ForeName': 'Wenxiu', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cen', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Jinlong', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Yunling', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Liqiu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Pang', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China.'}, {'ForeName': 'Jiazhu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Nanyang Centre for Public Administration, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, The North Sichuan Medical College, Nanchong, Sichuan Province, China. jiamingluo@nsmc.edu.cn.'}]",BMC women's health,['10.1186/s12905-022-01760-8']
1286,35635014,"Effects of methylphenidate on subjective sleep parameters in adults with ADHD: a prospective, non-randomized, non-blinded 6-week trial.","OBJECTIVE


Methylphenidate is a first-line treatment for ADHD; its contribution to sleep problems in adult ADHD is currently unclear. This study investigates (a) subjective sleep disturbances in a group of initially stimulant medication-naïve adults with ADHD and (b) reported changes in sleep problems after 6 weeks of methylphenidate treatment.
METHOD


A prospective, non-randomized, non-blinded, 6-week follow-up study utilising a self-report measure.
RESULTS


We found (1) a large difference in reported sleep quality between methylphenidate medication-naïve patients and controls at baseline, (2) a marked improvement in patients after methylphenidate medication, and (3) largest improvement for patients with the poorest reported sleep at baseline.
CONCLUSION


The study indicates that treatment with methylphenidate increases subjective sleep quality for at least some adults with ADHD.",2022,"We found (1) a large difference in reported sleep quality between methylphenidate medication-naïve patients and controls at baseline, (2) a marked improvement in patients after methylphenidate medication, and (3) largest improvement for patients with the poorest reported sleep at baseline.
","['adults with ADHD', 'a group of initially stimulant medication-naïve adults with ADHD and (b']","['methylphenidate', 'Methylphenidate', 'methylphenidate treatment']","['sleep problems', 'subjective sleep quality', 'sleep quality', 'subjective sleep disturbances', 'subjective sleep parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.068105,"We found (1) a large difference in reported sleep quality between methylphenidate medication-naïve patients and controls at baseline, (2) a marked improvement in patients after methylphenidate medication, and (3) largest improvement for patients with the poorest reported sleep at baseline.
","[{'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Low', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Vangkilde', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Julijana', 'Initials': 'J', 'LastName': 'le Sommer', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research (CNSR) and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Fagerlund', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research (CNSR) and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Glenthøj', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research (CNSR) and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Richardt Møllegaard', 'Initials': 'JRM', 'LastName': 'Jepsen', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research (CNSR) and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Habekost', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}]",Nordic journal of psychiatry,['10.1080/08039488.2022.2080253']
1287,35635482,"Effect of a Multi-Ingredient Supplement Designed to Regulate Mood on Physiological and Psychological Outcomes: A Randomized, Double-Blind, Placebo-Controlled Trial.","Stress is inevitable in college, and many students utilize alternatives to professional help such as supplements to manage stress, anxiety, or depression. A randomized, double-blind, placebo-controlled trial was conducted to assess the effectiveness of a multi-ingredient supplement (MIS) in supporting optimal mood balance and reducing daily stress among healthy collegiate-aged students (clinicaltrials.gov, NCT05109923). Participants (age 18-22) were randomly assigned to a placebo (PLA;  n  = 29) or MIS ( n  = 27) group and were asked to consume 2 capsules upon waking and before bed. Resting heart rate, blood pressure and salivary cortisol awakening response (CAR) were measured at weeks 2, 5 and 8. Depression, anxiety, stress, and affect were assessed weekly. There was a significant negative linear change in CAR, depression, stress, positive and negative affect throughout the study although only CAR differed by group. From week 2 to 5, MIS decreased, on average, from 0.22 μg/dL to 0.14 μg/dL (-0.8 μg/dL), whereas PLA, on average, increased from 0.11 μg/dL to 0.17 μg/dL. MIS continued to experience a decline in CAR, ending the study with an average CAR of 0.08 μg/dL. These results suggest that MIS may help maintain a healthy physiological response during stressful life events.",2022,"There was a significant negative linear change in CAR, depression, stress, positive and negative affect throughout the study although only CAR differed by group.","['healthy collegiate-aged students', 'Participants (age 18-22']","['multi-ingredient supplement (MIS', 'placebo (PLA;  n  = 29) or MIS', 'placebo', 'Placebo', 'Multi-Ingredient Supplement']","['Depression, anxiety, stress, and affect', 'Resting heart rate, blood pressure and salivary cortisol awakening response (CAR', 'Physiological and Psychological Outcomes', 'daily stress', 'CAR, depression, stress, positive and negative affect']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.245379,"There was a significant negative linear change in CAR, depression, stress, positive and negative affect throughout the study although only CAR differed by group.","[{'ForeName': 'Ann F', 'Initials': 'AF', 'LastName': 'Brown', 'Affiliation': 'Department of Movement Sciences, University of Idaho, Moscow, ID, USA.'}, {'ForeName': 'Clarissa M E', 'Initials': 'CME', 'LastName': 'Richardson', 'Affiliation': 'Department of Psychology, Illinois College, Jacksonville, IL, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Newby', 'Affiliation': 'Department of Movement Sciences, University of Idaho, Moscow, ID, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Pulsipher', 'Affiliation': 'Department of Movement Sciences, University of Idaho, Moscow, ID, USA.'}, {'ForeName': 'Talje', 'Initials': 'T', 'LastName': 'Hoene', 'Affiliation': 'Department of Psychology and Communication Studies, University of Idaho, Moscow, ID, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2022.2077880']
1288,35635335,Different intra-articular injection substances following temporomandibular joint arthroscopy and their effect on early postoperative period: A randomized clinical trial.,"OBJECTIVE


To compare the effect of plasma rich in growth factors (PRGF), hyaluronic acid (HA), and saline intra-articular injections following temporomandibular joint arthroscopy on decreasing pain and increasing maximal mouth opening.
METHODS


Included patients were randomized into three groups: PRGF group, hyaluronic acid group, and control group. Intra-articular injections were done at the end of the arthroscopy. Pain was measured using the VAS scale preoperatively, 7 days, 1 month, and 6 months postoperatively. Maximal mouth opening was measured preoperatively and 7 days postoperatively.
RESULTS


There was a statistically significant decrease in pain in all groups, although, the decrease was significantly greater in the HA group following surgery.
CONCLUSION


A hyaluronic acid injection following temporomandibular joint arthroscopy can decrease pain better than saline and platelet-rich plasma during the first postoperative week. However, the results do not differ in later postoperative periods.",2022,"There was a statistically significant decrease in pain in all groups, although, the decrease was significantly greater in the HA group following surgery.
",[],"['PRGF group, hyaluronic acid group, and control group', 'Different intra-articular injection substances', 'hyaluronic acid (HA), and saline intra-articular injections following temporomandibular joint arthroscopy', 'hyaluronic acid injection', 'temporomandibular joint arthroscopy']","['Maximal mouth opening', 'Pain', 'pain', 'pain better']",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.036686,"There was a statistically significant decrease in pain in all groups, although, the decrease was significantly greater in the HA group following surgery.
","[{'ForeName': 'Marijus', 'Initials': 'M', 'LastName': 'Leketas', 'Affiliation': 'Department of Maxillofacial Surgery, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Dominykas', 'Initials': 'D', 'LastName': 'Dvylys', 'Affiliation': 'Private Practice, Kaunas, Lithuania.'}, {'ForeName': 'Dovydas', 'Initials': 'D', 'LastName': 'Sakalys', 'Affiliation': 'Department of Maxillofacial Surgery, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Regimantas', 'Initials': 'R', 'LastName': 'Simuntis', 'Affiliation': 'Private Practice, Kaunas, Lithuania.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2022.2081445']
1289,35636031,Cognitive gains as a mechanism of functional capacity improvement in schizophrenia: Results from a multi-site randomized controlled trial.,"Randomized-controlled trials of Cognitive Enhancement Therapy (CET) reveal its impact on cognitive and functional improvements in schizophrenia and serve as an opportunity for causal claims of potential mediational relationships. In order to examine cognitive gains during CET as a mechanism for improving functional capacity, this secondary analysis included 86 outpatients in the early course of schizophrenia from an 18-month randomized-controlled trial of CET. Functional capacity was measured using the Brief UCSD Performance-Based Skills Assessment (UPSA-B) and cognitive performance by the MATRICS Consensus Cognitive Battery (MCCB) and additional measures of social cognition. Mixed-effects models were used to examine the effects of treatment on the UPSA-B changes and mediation through cognitive improvements. Changes in overall cognition proved to be a significant mediator of CET-related gains in functional capacity at mid-treatment and treatment completion. Exploratory models examining separable cognitive domains further found that improvements in attention, theory of mind, and emotion processing significantly mediated CET effects on functional capacity. This study suggests that CET has potential for improving functional capacity in individuals with schizophrenia, and that cognitive improvements partially mediate this relationship. This evidence can be beneficial for guiding more targeted approaches for rehabilitation in this population.",2022,Changes in overall cognition proved to be a significant mediator of CET-related gains in functional capacity at mid-treatment and treatment completion.,"['86 outpatients in the early course of schizophrenia', 'schizophrenia', 'individuals with schizophrenia']","['CET', 'Cognitive Enhancement Therapy (CET']","['Functional capacity', 'UPSA-B changes and mediation through cognitive improvements', 'Cognitive gains', 'Brief UCSD Performance-Based Skills Assessment (UPSA-B) and cognitive performance by the MATRICS Consensus Cognitive Battery (MCCB) and additional measures of social cognition']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",86.0,0.159133,Changes in overall cognition proved to be a significant mediator of CET-related gains in functional capacity at mid-treatment and treatment completion.,"[{'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Flores', 'Affiliation': 'School of Social Work, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: anaflores@pitt.edu.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Hogarty', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Raquelle I', 'Initials': 'RI', 'LastName': 'Mesholam-Gately', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Massachusetts Mental Health Center Division of Public Psychiatry, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Barrio', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Matcheri S', 'Initials': 'MS', 'LastName': 'Keshavan', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Massachusetts Mental Health Center Division of Public Psychiatry, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Shaun M', 'Initials': 'SM', 'LastName': 'Eack', 'Affiliation': 'School of Social Work, University of Pittsburgh, Pittsburgh, PA, USA; Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.05.016']
1290,35636516,Cognitive training using a mobile app as a coping tool against COVID-19 distress: A crossover randomized controlled trial.,"BACKGROUND


The COVID-19 pandemic has been suggested to constitute a broad base stressor with severe mental health consequences. mHealth applications are accessible self-help tools that can be used to reduce psychological distress during the pandemic. This randomized controlled trial evaluated the effects of mobile-based cognitive training exercises on COVID-19 related distress and maladaptive cognitions.
METHODS


Following initial screening (n = 924), participants scoring 1 standard deviations above the mean of the COVID-19 Distress Scale were randomized into two groups. Participants in the immediate-app group (iApp; n = 25) started using the application at baseline (T0) for 12 days (from T0 to T1). Participants in the delayed-app group (dApp; n = 22) started using the mobile application at T1 (crossover) and used it for the following 12 days (T1 to T2).
RESULTS


Intention to treat analyses indicated that the iApp group exhibited lower COVID-19 distress, lower depression, fewer intolerance of uncertainty and obsessive beliefs than the dApp group at T1. In addition, using the app for 12 consecutive days was associated with large effect-size reductions (Cohen's d ranging from 0.81 to 2.35) in COVID-19 distress and related maladaptive cognitions in the iApp group (from T0 to T1) and the dApp group (from T1 to T2). Moreover, these reductions were maintained at the follow-up.
LIMITATIONS


This study was a crossover trial with a relatively limited sample size and mainly female participants.
CONCLUSION


Our findings underscore the usefulness of brief, low-intensity, portable interventions in alleviating the negative effects of the pandemic on mental health.",2022,"RESULTS


Intention to treat analyses indicated that the iApp group exhibited lower COVID-19 distress, lower depression, fewer intolerance of uncertainty and obsessive beliefs than the dApp group at T1.","['COVID-19 distress', 'Following initial screening (n\u202f=\u202f924', 'relatively limited sample size and mainly female participants', 'participants scoring 1 standard deviations above the mean of the COVID-19 Distress Scale']",['mobile-based cognitive training exercises'],"['psychological distress', 'COVID-19 distress and related maladaptive cognitions', 'COVID-19 distress, lower depression, fewer intolerance of uncertainty and obsessive beliefs']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",924.0,0.129811,"RESULTS


Intention to treat analyses indicated that the iApp group exhibited lower COVID-19 distress, lower depression, fewer intolerance of uncertainty and obsessive beliefs than the dApp group at T1.","[{'ForeName': 'Burcin', 'Initials': 'B', 'LastName': 'Akin-Sari', 'Affiliation': 'Department of Psychology, Baskent University, Ankara, Turkey. Electronic address: bakinsari@baskent.edu.tr.'}, {'ForeName': 'Mujgan', 'Initials': 'M', 'LastName': 'Inozu', 'Affiliation': 'Department of Psychology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'A Bikem', 'Initials': 'AB', 'LastName': 'Haciomeroglu', 'Affiliation': 'Department of Psychology, Ankara Hacı Bayram Veli University, Ankara, Turkey.'}, {'ForeName': 'Ezgi', 'Initials': 'E', 'LastName': 'Trak', 'Affiliation': 'Department of Psychology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Damla', 'Initials': 'D', 'LastName': 'Tufan', 'Affiliation': 'Department of Psychology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Doron', 'Affiliation': 'Interdisiplinary Center of Herzliya to: Reichman University (IDC) Herzliya, Tel Aviv, Israel.'}]",Journal of affective disorders,['10.1016/j.jad.2022.05.118']
1291,35636467,Carbon dioxide rises beyond acceptable safety levels in children under nose and mouth covering: Results of an experimental measurement study in healthy children.,"Nose and mouth covering (NMC) has been made compulsory for children in many countries during the Covid-19 pandemic. We wanted to determine the average CO 2  levels in inhaled air with NMC in children between age 6 and 17. We used short term measurements under surgical masks and FFP2 masks according to European norm EN 149, compared to baseline in an experimental, intra-individually controlled study over 25 min. CO 2  content was measured every 15 s using an automated dual-wavelength infrared CO 2  measurement device (G100, Geotech, Leamington Spa, UK) over 25 min in a short-term experimental setting, with children seated. After baseline measurement children were provided with two types of commonly worn NMC: surgical masks and FFP2--masks in randomized sequence for 3 min each. We kept ambient CO 2 -levels below 1000 parts per million (ppm) through frequent ventilation. We measured breathing frequency and pulse as potential physiological moderator variables. Forty-five children, 25 boys, 20 girls, with a mean age of 10.7 years (standard deviation 2.6) were measured. We measured 13,100 ppm (SD 380) under surgical mask and 13,900 ppm (SD 370) under FFP2 mask in inhaled air. A linear model with age as a covariate showed a highly significant effect of the condition (p < 1*10 -9 ). We measured 2,700 ppm (SD 100) CO 2  at pre-baseline and 2,800 ppm (SD 100) at post-baseline, a non-significant small difference. Appropriate contrasts revealed that the change was due to the masks only and the difference between the two types of masks was small and not significant. Wearing of NMC (surgical masks or FFP2- -masks) raises CO 2  content in inhaled air quickly to a very high level in healthy children in a seated resting position that might be hazardous to children's health.",2022,Appropriate contrasts revealed that the change was due to the masks only and the difference between the two types of masks was small and not significant.,"['children between age 6 and 17', 'healthy children', 'Forty-five children, 25 boys, 20 girls, with a mean age of 10.7 years (standard deviation 2.6) were measured', 'children under nose and mouth covering']","['NMC (surgical masks or FFP2- -masks', 'surgical mask and 13,900\xa0ppm (SD 370) under FFP2 mask in inhaled air', 'Carbon dioxide rises', 'Nose and mouth covering (NMC']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",[],45.0,0.109124,Appropriate contrasts revealed that the change was due to the masks only and the difference between the two types of masks was small and not significant.,"[{'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Walach', 'Affiliation': 'Change Health Science Institute, Berlin, Germany. Electronic address: hwalac@gmail.com.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Traindl', 'Affiliation': 'Traindl-consult, Vienna, Austria. Electronic address: traindl@traindl-consult.at.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Prentice', 'Affiliation': 'Psychotherapeutic Practice, Müllheim, Germany. Electronic address: juliane.prentice@protonmail.com.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Weikl', 'Affiliation': 'Obstetric, Gynecological and General Practice, Passau, Germany. Electronic address: Dr.Weikl@t-online.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Diemer', 'Affiliation': 'General Practice, Gernsbach, Germany. Electronic address: praxisdiemer@gmx.de.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kappes', 'Affiliation': 'Anna Kappes, Psychotherapeutic Practice for Children and Youths, Müllheim, Germany. Electronic address: anna_kappes@gmx.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hockertz', 'Affiliation': 'Tpi Consult GmbH, Bollschweil, Germany. Electronic address: Prof.Hockertz@tpi-consult.de.'}]",Environmental research,['10.1016/j.envres.2022.113564']
1292,35637604,Assessment of the need of a waiting period after pulmonary vein isolation with the ablation index software.,"PURPOSE


Since the widespread availability of contact-force sensing catheters, the need for a waiting period after pulmonary vein isolation (PVI) has not been reassessed. We aim to evaluate whether a waiting period is still necessary after PVI guided by the ablation Index (AI).
METHODS


Prospective, multicenter, randomized study of consecutive patients referred for paroxysmal atrial fibrillation (AF) ablation from May 2019 to February 2020. Patients were randomized in a 1:1 ratio to PVI with versus without a waiting period of 20 min. Acute pulmonary vein (PV) reconnection after adenosine challenge was the primary endpoint. A per-protocol analysis was designed to determine whether a strategy of dismissing the waiting period after PVI was noninferior to waiting for 20 min for identifying acute PV reconnection. PVI was guided by tailored AI values and an interlesion distance ≤6 mm.
RESULTS


During the enrollment period, 167 patients (56% males, mean age of 57 ± 14 years) fulfilled the study inclusion criteria - 84 patients (308 PV) in the waiting period group (Group A) and 83 patients (314 PV) in the group without a waiting period (Group B). Acute PV reconnection was identified in 3.8% (95% confidence interval [CI], 1.7%-5.9%) of PVs in the study group B compared to 2.9% (95% CI, 1.0%-4.8%) of PVs in the Group A (p = .002 for non-inferiority). At 1-year follow-up, there was no significant difference in arrhythmia recurrence between groups (9.5% in Group A vs. 9.6% in Group B, hazard ratio: 1.03 [95% CI, 0.39-2.73], p = .98).
CONCLUSION


In paroxysmal AF patients submitted to ablation, a tailored PVI guided by the AI rendered a 20-min waiting period unnecessary.",2022,"Acute PV reconnection was identified in 3.8% (95% CI, 1.7% to 5.9%) of PVs in the study group B compared to 2.9% (95% CI, 1.0% to 4.8%) of PVs in the group A (p=0.002 for non-inferiority).","['167 patients (56% males, mean age of 57±14 years) fulfilled the study inclusion criteria - 84 patients (308 PV) in the waiting period group (group A) and 83 patients (314 PV) in the group without a waiting period (group B', 'consecutive patients referred for paroxysmal atrial fibrillation (AF) ablation from May 2019 to February 2020']",[],"['arrhythmia recurrence', 'Acute PV reconnection', 'Acute pulmonary vein (PV) reconnection']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",[],"[{'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}]",,0.0344725,"Acute PV reconnection was identified in 3.8% (95% CI, 1.7% to 5.9%) of PVs in the study group B compared to 2.9% (95% CI, 1.0% to 4.8%) of PVs in the group A (p=0.002 for non-inferiority).","[{'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Sousa', 'Affiliation': ""Pacing and Electrophysiology Unit, Cardiology Department, Coimbra's Hospital and University Center, Coimbra, Portugal.""}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Barra', 'Affiliation': 'Cardiology Department, Hospital da Luz Arrábida, V. N. Gaia, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Adão', 'Affiliation': 'Cardiology Department, University Hospital Center of São João, Porto, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Primo', 'Affiliation': 'Cardiology Department, Vila Nova de Gaia and Espinho Hospital Center, V. N. Gaia, Portugal.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Khoueiry', 'Affiliation': 'Cardiology Department, Clinique Saint Pierre, Perpignan, France.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Puga', 'Affiliation': ""Pacing and Electrophysiology Unit, Cardiology Department, Coimbra's Hospital and University Center, Coimbra, Portugal.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lebreiro', 'Affiliation': 'Cardiology Department, University Hospital Center of São João, Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Fonseca', 'Affiliation': 'Cardiology Department, Vila Nova de Gaia and Espinho Hospital Center, V. N. Gaia, Portugal.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lagrange', 'Affiliation': 'Cardiology Department, Clinique Saint Pierre, Perpignan, France.'}, {'ForeName': 'Lino', 'Initials': 'L', 'LastName': 'Gonçalves', 'Affiliation': ""Pacing and Electrophysiology Unit, Cardiology Department, Coimbra's Hospital and University Center, Coimbra, Portugal.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiovascular electrophysiology,['10.1111/jce.15568']
1293,35640058,A Smartphone App for Parental Management of Adolescent Conduct Problems: Randomized Clinical Trial of iKinnect.,"OBJECTIVE


This study evaluates iKinnect, a linked caregiver-teen mobile app system designed to address serious adolescent conduct problems through a focus on key targets of evidence-based treatments for juvenile offending, such as parent expectation setting, monitoring, consistency, and positive reinforcement. Additional gamification and autonomy-supporting features are designed to maximize youth engagement. Digital therapeutics such as mobile apps have great potential to expand access to effective interventions, particularly for youth who engage in serious conduct problems and substance abuse, since most never receive an evidence-based treatment and few apps exist for these concerns.
METHODS


This randomized clinical trial used a short-term (12 week) longitudinal design with four time points. Recruited was a U.S. national sample of teens ( n  = 72, age 13-17, 59.7% male, 68.1% White) receiving services for a serious conduct problem and their primary caregiver. The efficacy of iKinnect, used by parent and teen dyads, was measured against an active control condition, Life360, an app that provided mutual GPS-based location tracking to dyads.
RESULTS


Across 12 weeks of app use, youth who used iKinnect showed significantly greater reductions in alcohol use, marijuana use, school delinquency, status offenses, and general delinquency than did controls. Parents who used iKinnect Reported greater improvements in structure/rule clarity and discipline consistency relative to control parents. Teen and parent iKinnect app use and acceptability ratings were high.
CONCLUSIONS


Real-world use of iKinnect in future applications can, like other emerging digital health technologies, help to expand the reach of evidence-based interventions to children, youth, and families.Registered at clinicaltrials.gov (NCT03065517).",2022,"Across 12 weeks of app use, youth who used iKinnect showed significantly greater reductions in alcohol use, marijuana use, school delinquency, status offenses, and general delinquency than did controls.","['Adolescent Conduct Problems', 'Recruited was a U.S. national sample of teens ( n  = 72, age 13-17, 59.7% male, 68.1% White) receiving services for a serious conduct problem and their primary caregiver']",[],"['structure/rule clarity and discipline consistency relative', 'alcohol use, marijuana use, school delinquency, status offenses, and general delinquency', 'acceptability ratings']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}]",[],"[{'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022438', 'cui_str': 'Juvenile Delinquency'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0745662,"Across 12 weeks of app use, youth who used iKinnect showed significantly greater reductions in alcohol use, marijuana use, school delinquency, status offenses, and general delinquency than did controls.","[{'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Schaeffer', 'Affiliation': 'School of Medicine, University of Maryland.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Dimeff', 'Affiliation': 'Evidence Based Practice Institute, Inc.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Koerner', 'Affiliation': 'Evidence Based Practice Institute, Inc.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Chung', 'Affiliation': 'Evidence Based Practice Institute, Inc.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kelley-Brimer', 'Affiliation': 'Evidence Based Practice Institute, Inc.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Kako', 'Affiliation': 'Evidence Based Practice Institute, Inc.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ilac', 'Affiliation': 'Evidence Based Practice Institute, Inc.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tuerk', 'Affiliation': 'Department of Human Services, University of Virginia School of Education.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carroll', 'Affiliation': 'Department of Media Design, Parsons School of Design.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Beadnell', 'Affiliation': 'Evaluation Specialists.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2022.2070851']
1294,35640787,Methylphenidate remediates aberrant brain network dynamics in children with attention-deficit/hyperactivity disorder: A randomized controlled trial.,"Methylphenidate is a widely used first-line treatment for attention deficit/hyperactivity disorder (ADHD), but the underlying circuit mechanisms are poorly understood. Here we investigate whether a single dose of osmotic release oral system methylphenidate can remediate attention deficits and aberrancies in functional circuit dynamics in cognitive control networks, which have been implicated in ADHD. In a randomized placebo-controlled double-blind crossover design, 27 children with ADHD were scanned twice with resting-state functional MRI and sustained attention was examined using a continuous performance task under methylphenidate and placebo conditions; 49 matched typically-developing (TD) children were scanned once for comparison. Dynamic time-varying cross-network interactions between the salience (SN), frontoparietal (FPN), and default mode (DMN) networks were examined in children with ADHD under both administration conditions and compared with TD children. Methylphenidate improved sustained attention on a continuous performance task in children with ADHD, when compared to the placebo condition. Children with ADHD under placebo showed aberrancies in dynamic time-varying cross-network interactions between the SN, FPN and DMN, which were remediated by methylphenidate. Multivariate classification analysis confirmed that methylphenidate remediates aberrant dynamic brain network interactions. Furthermore, dynamic time-varying network interactions under placebo conditions predicted individual differences in methylphenidate-induced improvements in sustained attention in children with ADHD. These findings suggest that a single dose of methylphenidate can remediate deficits in sustained attention and aberrant brain circuit dynamics in cognitive control circuits in children with ADHD. Findings identify a novel brain circuit mechanism underlying a first-line pharmacological treatment for ADHD, and may inform clinically useful biomarkers for evaluating treatment outcomes.",2022,"Children with ADHD under placebo showed aberrancies in dynamic time-varying cross-network interactions between the SN, FPN and DMN, which were remediated by methylphenidate.","['Children with ADHD under', 'children with ADHD', 'children with attention-deficit/hyperactivity disorder', '27 children with ADHD', 'children with ADHD under both administration conditions and compared with TD children']","['osmotic release oral system methylphenidate', 'Methylphenidate', 'methylphenidate', 'methylphenidate and placebo', 'placebo']","['Dynamic time-varying cross-network interactions between the salience (SN), frontoparietal (FPN), and default mode (DMN) networks', 'aberrancies in dynamic time-varying cross-network interactions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0029391', 'cui_str': 'Osmosis'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",27.0,0.226123,"Children with ADHD under placebo showed aberrancies in dynamic time-varying cross-network interactions between the SN, FPN and DMN, which were remediated by methylphenidate.","[{'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94304, USA; Research Center for Child Mental Development, University of Fukui, Fukui, 910-1193, Japan; Division of Developmental Higher Brain Functions, United Graduate School of Child Development, University of Fukui, Fukui, 910-1193, Japan; Department of Child and Adolescent Psychological Medicine, University of Fukui Hospital, Fukui, 910-1193, Japan. Electronic address: mizunoy@u-fukui.ac.jp.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94304, USA; Wu Tsai Neurosciences Institute, Stanford University, Stanford, CA 94304, USA; Maternal & Child Health Research Institute, Stanford University, Stanford, CA 94304, USA.'}, {'ForeName': 'Kaustubh', 'Initials': 'K', 'LastName': 'Supekar', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94304, USA; Wu Tsai Neurosciences Institute, Stanford University, Stanford, CA 94304, USA; Maternal & Child Health Research Institute, Stanford University, Stanford, CA 94304, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Makita', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui, 910-1193, Japan; Division of Developmental Higher Brain Functions, United Graduate School of Child Development, University of Fukui, Fukui, 910-1193, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Takiguchi', 'Affiliation': 'Division of Developmental Higher Brain Functions, United Graduate School of Child Development, University of Fukui, Fukui, 910-1193, Japan; Department of Child and Adolescent Psychological Medicine, University of Fukui Hospital, Fukui, 910-1193, Japan.'}, {'ForeName': 'Akemi', 'Initials': 'A', 'LastName': 'Tomoda', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui, 910-1193, Japan; Division of Developmental Higher Brain Functions, United Graduate School of Child Development, University of Fukui, Fukui, 910-1193, Japan; Department of Child and Adolescent Psychological Medicine, University of Fukui Hospital, Fukui, 910-1193, Japan. Electronic address: atomoda@u-fukui.ac.jp.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94304, USA; Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA 94304, USA; Wu Tsai Neurosciences Institute, Stanford University, Stanford, CA 94304, USA; Maternal & Child Health Research Institute, Stanford University, Stanford, CA 94304, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2022.119332']
1295,35642801,"A commentary on ""Ultrasound-guided versus laparoscopic-guided subcostal transversus abdominis plane (TAP) block versus No TAP block in laparoscopic cholecystectomy; a randomized double-blind controlled trial"" (Int. J. Surg. 2022;101:106639).",,2022,,['laparoscopic cholecystectomy'],['Ultrasound-guided versus laparoscopic-guided subcostal transversus abdominis plane (TAP) block versus No TAP block'],[],"[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]",[],,0.784725,,"[{'ForeName': 'Xin-Tao', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China. Electronic address: mz_lxt@163.com.""}, {'ForeName': 'Fu-Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China. Electronic address: xuefushan@aliyun.com.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Tian', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China. Electronic address: tiantchina@126.com.""}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2022.106683']
1296,35643360,Nutritional quality of calorie restricted diets in the CALERIE™ 1 trial.,"OBJECTIVES


The aim was to determine the nutritional adequacy of calorie restricted (CR) diets during CR interventions up to 12 months.
METHODS


The Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE™) phase 1 trial consisted of 3 single-site studies to test the feasibility and effectiveness of CR in adults without obesity. After baseline assessments, participants who were randomized to a CR intervention received education and training from registered dietitians on how to follow a healthful CR diet. Food diaries were completed at baseline and during the CR interventions (~6, 9, and 12 months) when participants were self-selecting CR diets. Diaries were analyzed for energy, macronutrients, fiber, 11 vitamins, and 9 minerals. Nutritional adequacy was defined by sex- and age-specific Estimated Average Requirement (EAR) or Adequate Intake (AI) criteria for each nutrient. Diet quality was evaluated using the PANDiet diet quality index.
RESULTS


Eighty-eight CR participants (67% women, age 40 ± 9 y, BMI 27.7 ± 1.5 kg/m 2 ) were included in the analysis. Dietary intake of fiber and most vitamins and minerals increased during CR. More than 90% of participants achieved 100% of EAR or AI during CR for 2 of 4 macronutrients (carbohydrate and protein), 6 of 11 vitamins (A, B1, B2, B3, B6, B12), and 6 of 9 minerals assessed (copper, iron, phosphorus, selenium, sodium, zinc). Nutrients for which <90% of participants achieved adequacy included fiber, omega-3 fatty acids, vitamins B5, B9, C, E, and K, and the minerals calcium, magnesium, and potassium. The PANDiet diet quality index improved from 72.9 ± 6.0% at baseline to 75.7 ± 5.2% during CR (p < 0.0001).
CONCLUSION


Long-term, calorie-restricted diets were nutritionally equal or superior to baseline ad libitum diets among adults without obesity. Our results support modest calorie restriction as a safe strategy to promote healthy aging without compromising nutritional adequacy or diet quality.",2022,"More than 90% of participants achieved 100% of EAR or AI during CR for 2 of 4 macronutrients (carbohydrate and protein), 6 of 11 vitamins (A, B1, B2, B3, B6, B12), and 6 of 9 minerals assessed (copper, iron, phosphorus, selenium, sodium, zinc).","['Eighty-eight CR participants (67% women, age 40\u202f±\u202f9 y, BMI 27.7\u202f±\u202f1.5\u202fkg/m 2 ) were included in the analysis', 'adults without obesity']","['calorie-restricted diets were nutritionally equal or superior to baseline ad libitum diets', 'calorie restricted (CR) diets', 'CR intervention received education and training from registered dietitians on how to follow a healthful CR diet', 'Energy']","['adequacy included fiber, omega-3 fatty acids, vitamins B5, B9, C, E, and K, and the minerals calcium, magnesium, and potassium', 'PANDiet diet quality index', 'Nutritional adequacy', 'Food diaries', 'Diet quality']","[{'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0030342', 'cui_str': 'Pantothenic Acid'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}]",,0.0595107,"More than 90% of participants achieved 100% of EAR or AI during CR for 2 of 4 macronutrients (carbohydrate and protein), 6 of 11 vitamins (A, B1, B2, B3, B6, B12), and 6 of 9 minerals assessed (copper, iron, phosphorus, selenium, sodium, zinc).","[{'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Racette', 'Affiliation': 'Washington University School of Medicine, Program in Physical Therapy, St. Louis, MO, United States of America; Washington University School of Medicine, Department of Medicine, St. Louis, MO, United States of America. Electronic address: racettes@wustl.edu.'}, {'ForeName': 'Valene Garr', 'Initials': 'VG', 'LastName': 'Barry', 'Affiliation': 'Washington University School of Medicine, Program in Physical Therapy, St. Louis, MO, United States of America; Washington University School of Medicine, Department of Obstetrics and Gynecology, St. Louis, MO, United States of America.'}, {'ForeName': 'Connie W', 'Initials': 'CW', 'LastName': 'Bales', 'Affiliation': 'Durham VA Medical Center, Durham, NC, United States of America; Duke University School of Medicine, Department of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'McCrory', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Energy Metabolism Lab, Boston, MA, United States of America; Boston University, Department of Health Sciences, Boston, MA, United States of America.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Obert', 'Affiliation': 'Washington University School of Medicine, Department of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Cheryl H', 'Initials': 'CH', 'LastName': 'Gilhooly', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Energy Metabolism Lab, Boston, MA, United States of America.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Roberts', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Energy Metabolism Lab, Boston, MA, United States of America.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States of America.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States of America.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Energy Metabolism Lab, Boston, MA, United States of America.'}]",Experimental gerontology,['10.1016/j.exger.2022.111840']
1297,35643358,The effect of casein hydrolysate intake on cerebral neural regulation during cognitive tasks in the elderly.,"Human and animal studies have shown that casein peptide (casein hydrolysate) has positive effects on cognitive function. This double-blind randomized controlled study aimed to investigate whether single ingestion of casein peptide could affect cognitive function (executive function) and cognitive neural activity in healthy older adults. We assigned 47 participants to one of the three dietary supplements as follows: casein peptide (TMP, n = 15), casein (TMC, n = 16), and indigestible dextrin (TMF, n = 16). Dietary supplements were ingested 30 min before starting the experiment; moreover, neural activity while performing the task-switching reaction time (SWT) trial was assessed through functional magnetic resonance imaging (fMRI). Additionally, we used a visual analog scale (VAS) test to assess the pre- and post-test feeling and mood. Regarding the parameters of the SWT trial, there were no significant among-group differences in the reaction time, accuracy rate, and %SwitchCost. Contrastingly, the fMRI experiment revealed among-group differences in the main effects in the medial frontal gyrus, Supplementary motor cortex (SMC), posterior cingulate gyrus (PCg), and amygdala (Amyg). Specifically, there was a significant decrease in the neural activities in the SMC and PCg in the TMP group than in the other two groups. Moreover, there was a significant increase in the neural activity in the Amyg in the TMP group compared with the TMF, but not the TMC, group. Furthermore, the VAS score was significantly higher in the TMP group than in the other two groups. There were no recorded adverse outcomes. Our findings suggested that TMP ingestion by older adults could temporarily suppress complementary neural activity in specific brain regions involved in executive functions, as well as default mode network activity, which could improve cognitive neural activities.",2022,"Regarding the parameters of the SWT trial, there were no significant among-group differences in the reaction time, accuracy rate, and %SwitchCost.","['cognitive tasks in the elderly', 'healthy older adults', '47 participants to one of the three dietary supplements as follows']","['TMF', 'casein peptide (casein hydrolysate', 'TMP ingestion', 'TMP', 'casein peptide', 'casein hydrolysate intake', 'casein peptide (TMP, n\u202f=\u202f15), casein (TMC, n\u202f=\u202f16), and indigestible dextrin (TMF, n\u202f=\u202f16']","['visual analog scale (VAS) test to assess the pre- and post-test feeling and mood', 'cerebral neural regulation', 'neural activities', 'cognitive function (executive function) and cognitive neural activity', 'VAS score', 'medial frontal gyrus, Supplementary motor cortex (SMC), posterior cingulate gyrus (PCg), and amygdala (Amyg', 'reaction time, accuracy rate, and %SwitchCost', 'neural activity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0244554', 'cui_str': 'TMF protocol'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0054845', 'cui_str': 'Casein hydrolysate'}, {'cui': 'C0040079', 'cui_str': 'Deoxythymidylic acid'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0011808', 'cui_str': 'Dextrins'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",47.0,0.174997,"Regarding the parameters of the SWT trial, there were no significant among-group differences in the reaction time, accuracy rate, and %SwitchCost.","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'School of Engineering, Department of Humanities and School Sciences, Tokyo Denki University, 5 Senju-Asahi-cho, Adachi-ku, Tokyo 120-8551, Japan. Electronic address: kimura@cck.dendai.ac.jp.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Saito', 'Affiliation': 'Wellness & Nutrition Science Institute, R&D Division, Morinaga Milk Industry Co., Ltd., 1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref. 252-8583, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Wellness & Nutrition Science Institute, R&D Division, Morinaga Milk Industry Co., Ltd., 1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref. 252-8583, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Takeda', 'Affiliation': 'Food Research & Development Institute, R&D Division, Morinaga Milk Industry Co., Ltd., 1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref. 252-8583, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2022.111853']
1298,35649301,"Decision making in a clinical trial for a life-threatening illness: Therapeutic expectation, not misconception.","Potential participants for clinical trials which aim to define treatments for life-threatening conditions are often extremely unwell. When exploring why individuals participate in clinical trials one common observation is a misplaced expectation of personal benefit - a therapeutic misconception. The care offered in some clinical trials is of a higher standard than is routinely available and this has led to criticism around the freedom of choice to enrol - structural coercion. We embedded an ethnographic study within a randomised controlled trial for HIV-associated cryptococcal meningitis in Gaborone, Botswana and Kampala, Uganda. We aimed to gain an understanding of decision-making around the trial and how this was impacted by the study design and broader social context. We conducted in-depth interviews with trial participants, surrogate decision makers and researchers, combined these with direct observations and analysed data using thematic analysis. Between January 2020 and June 2021 we interviewed 89 individuals. We found previous exposure to and awareness of clinical research was limited, as was understanding of the trial objectives and design. Through observations and engagement with healthcare facilities decision-makers were able to identify the trial as providing the best possible chance of survival. Hesitation and reluctance were mostly due to fear of lumbar punctures which was sometimes based on rumours but often based on tragic personal experience. Despite fear, and sometimes conviction that they would die, individuals agreed to consent, often against the wishes of family members. Reassurance and confidence came from trust in routine care staff and the research team but also from fellow participants and their surrogates. We argue that participants made informed decisions based on a therapeutic expectation from the trial and that rather than being the result of structural coercion this was an informed and voluntary choice.",2022,"Despite fear, and sometimes conviction that they would die, individuals agreed to consent, often against the wishes of family members.","['Between January 2020 and June 2021 we interviewed 89 individuals', 'life-threatening illness', 'HIV-associated cryptococcal meningitis in Gaborone, Botswana and Kampala, Uganda']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0085436', 'cui_str': 'Cryptococcal meningitis'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],[],89.0,0.273274,"Despite fear, and sometimes conviction that they would die, individuals agreed to consent, often against the wishes of family members.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Lawrence', 'Affiliation': 'Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, UK; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana. Electronic address: david.s.lawrence@lshtm.ac.uk.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Ssali', 'Affiliation': 'Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Institute, Entebbe, Uganda; Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, UK.'}, {'ForeName': 'Neo', 'Initials': 'N', 'LastName': 'Moshashane', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Nabaggala', 'Affiliation': 'Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Institute, Entebbe, Uganda.'}, {'ForeName': 'Lebogang', 'Initials': 'L', 'LastName': 'Maphane', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Harrison', 'Affiliation': ""Institute of Infection and Immunity, St George's University London, London, UK; Clinical Academic Group in Infection and Immunity, St George's University Hospitals NHS Foundation Trust, London, UK; MRC Centre for Medical Mycology, University of Exeter, Exeter, UK.""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Jarvis', 'Affiliation': 'Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, UK; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Social Aspects of Health Programme, MRC/UVRI & LSHTM Uganda Research Institute, Entebbe, Uganda; Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2022.115082']
1299,35650583,"ALIMUS-We are feeding! Study protocol of a multi-center, cluster-randomized controlled trial on the effects of a home garden and nutrition counseling intervention to reduce child undernutrition in rural Burkina Faso and Kenya.","BACKGROUND


Climate change heavily affects child nutritional status in sub-Saharan Africa. Agricultural and dietary diversification are promising tools to balance agricultural yield losses and nutrient deficits in crops. However, rigorous impact evaluation of such adaptation strategies is lacking. This project will determine the potential of an integrated home gardening and nutrition counseling program as one possible climate change adaptation strategy to improve child health in rural Burkina Faso and Kenya.
METHODS


Based on careful co-design with stakeholders and beneficiaries, we conduct a multi-center, cluster-randomized controlled trial with 2 × 600 households in North-Western Burkina Faso and in South-Eastern Kenya. We recruit households with children at the age of complementary feed introduction (6-24 months) and with access to water sources. The intervention comprises the bio-diversification of horticultural home gardens and nutritional health counseling, using the 7 Essential Nutrition Action messages by the World Health Organization. After 12-months of follow-up, we will determine the intervention effect on the primary health outcome height-for-age z-score, using multi-level mixed models in an intention-to-treat approach. Secondary outcomes comprise other anthropometric indices, iron and zinc status, dietary behavior, malaria indicators, and household socioeconomic status.
DISCUSSION


This project will establish the potential of a home gardening and nutrition counseling program to counteract climate change-related quantitative and qualitative agricultural losses, thereby improving the nutritional status among young children in rural sub-Saharan Africa.
TRIAL REGISTRATION


German Clinical Trials Register (DRKS) DRKS00019076 . Registered on 27 July 2021.",2022,"After 12-months of follow-up, we will determine the intervention effect on the primary health outcome height-for-age z-score, using multi-level mixed models in an intention-to-treat approach.","['households with children at the age of complementary feed introduction (6-24\u2009months) and with access to water sources', 'child undernutrition in rural Burkina Faso and Kenya', 'child health in rural Burkina Faso and Kenya', 'young children in rural sub-Saharan Africa', '600 households in North-Western Burkina Faso and in South-Eastern Kenya']","['home garden and nutrition counseling intervention', 'nutrition counseling program']","['anthropometric indices, iron and zinc status, dietary behavior, malaria indicators, and household socioeconomic status']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]",,0.0886167,"After 12-months of follow-up, we will determine the intervention effect on the primary health outcome height-for-age z-score, using multi-level mixed models in an intention-to-treat approach.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mank', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital Heidelberg, Heidelberg University, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.'}, {'ForeName': 'Raissa', 'Initials': 'R', 'LastName': 'Sorgho', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital Heidelberg, Heidelberg University, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.'}, {'ForeName': 'Fanta', 'Initials': 'F', 'LastName': 'Zerbo', 'Affiliation': 'Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.'}, {'ForeName': 'Moubassira', 'Initials': 'M', 'LastName': 'Kagoné', 'Affiliation': 'Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Oguso', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), Kisumu, Kenya.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mbata', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), Kisumu, Kenya.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Khagayi', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), Kisumu, Kenya.'}, {'ForeName': 'Erick M O', 'Initials': 'EMO', 'LastName': 'Muok', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), Kisumu, Kenya.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Danquah', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital Heidelberg, Heidelberg University, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany. ina.danquah@uni-heidelberg.de.'}]",Trials,['10.1186/s13063-022-06423-5']
1300,35650562,The impact of working as a peer worker in mental health services: a longitudinal mixed methods study.,"BACKGROUND


Peer workers are increasingly employed in mental health services to use their own experiences of mental distress in supporting others with similar experiences. While evidence is emerging of the benefits of peer support for people using services, the impact on peer workers is less clear. There is a lack of research that takes a longitudinal approach to exploring impact on both employment outcomes for peer workers, and their experiences of working in the peer worker role.
METHODS


In a longitudinal mixed methods study, 32 peer workers providing peer support for discharge from inpatient to community mental health care - as part of a randomised controlled trial - undertook in-depth qualitative interviews conducted by service user researchers, and completed measures of wellbeing, burnout, job satisfaction and multi-disciplinary team working after completing training, and four and 12 months into the role. Questionnaire data were summarised and compared to outcomes for relevant population norms, and changes in outcomes were analysed using paired t-tests. Thematic analysis and interpretive workshops involving service user researchers were used to analysis interview transcripts. A critical interpretive synthesis approach was used to synthesise analyses of both datasets.
RESULTS


For the duration of the study, all questionnaire outcomes were comparable with population norms for health professionals or for the general population. There were small-to-medium decreases in wellbeing and aspects of job satisfaction, and increase in burnout after 4 months, but these changes were largely not maintained at 12 months. Peer workers felt valued, empowered and connected in the role, but could find it challenging to adjust to the demands of the job after initial optimism. Supervision and being part of a standalone peer worker team was supportive, although communication with clinical teams could be improved.
CONCLUSIONS


Peer workers seem no more likely to experience negative impacts of working than other healthcare professionals but should be well supported as they settle into post, provided with in-work training and support around job insecurity. Research is needed to optimise working arrangements for peer workers alongside clinical teams.",2022,"For the duration of the study, all questionnaire outcomes were comparable with population norms for health professionals or for the general population.","['32 peer workers providing peer support for discharge from inpatient to community mental health care ', 'mental health services']",[],['wellbeing and aspects of job satisfaction'],"[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]",[],"[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",32.0,0.0680804,"For the duration of the study, all questionnaire outcomes were comparable with population norms for health professionals or for the general population.","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gillard', 'Affiliation': 'City, University of London, London, UK. steven.gillard@city.ac.uk.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Barlow', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Bhattacharya', 'Affiliation': 'East London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Binfield', 'Affiliation': 'East London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Eborall', 'Affiliation': 'South London & Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Faulkner', 'Affiliation': 'Independent Survivor Researcher, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Lucy P', 'Initials': 'LP', 'LastName': 'Goldsmith', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lucock', 'Affiliation': 'University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Marks', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Rosaleen', 'Initials': 'R', 'LastName': 'Morshead', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': ""South West London & St George's Mental Health NHS Trust, London, UK.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Queen Mary, University of London, London, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Repper', 'Affiliation': 'Implementing Recovery through Organisational Change, Nottingham, UK.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Rinaldi', 'Affiliation': ""South West London & St George's Mental Health NHS Trust, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Worner', 'Affiliation': 'National Suicide Prevention Alliance, London, UK.'}]",BMC psychiatry,['10.1186/s12888-022-03999-9']
1301,35653934,Cognitive flexibility improves in cognitive behavioral therapy for irritable bowel syndrome but not nonspecific education/support.,"This study tested the novel hypothesis that CBT-treated IBS patients who learn to self-manage painful GI symptoms by targeting rigid cognitive style show improvement in cognitive flexibility, GI symptoms (e.g., abdominal pain), and quality of life. Participants included 130 Rome-III diagnosed IBS patients (M age = 40.3, F = 83%) with moderate-to-severe symptoms randomly assigned to either cognitive behavioral therapy (CBT; N = 86) or a nonspecific education/support (EDU) comparator (N = 44). Participants completed an assessment battery at baseline and post-treatment 2 weeks after 10-week acute treatment phase. Measures included cognitive flexibility, psychological flexibility, emotion regulation strategies, IBS symptom severity, quality of life (QOL), and distress. CBT but not EDU patients showed significant GI sympton improvement from baseline to post-treatment in cognitive flexibility. For CBT patients, changes in cognitive flexibility were significantly associated with changes in IBS symptom severity, abdominal pain, and IBS QOL. Neither condition showed significant changes in psychological flexibility (Acceptance and Action Questionnaire-II) or use of emotion regulation strategies (Emotion Regulation Questionnaire). The ability to self-manage painful IBS symptoms refractory to conventional medical and dietary treatments is related to the ability to respond flexibly across shifting contexts using cognitive change procedures featured in CBT for IBS.",2022,"For CBT patients, changes in cognitive flexibility were significantly associated with changes in IBS symptom severity, abdominal pain, and IBS QOL.","['patients who learn to self-manage painful GI symptoms', 'Participants included 130 Rome-III diagnosed IBS patients (M age\u202f=\u202f40.3, F\u202f=\u202f83%) with moderate-to-severe symptoms randomly assigned to either']","['CBT-treated IBS', 'cognitive behavioral therapy', 'cognitive behavioral therapy (CBT; N\u202f=\u202f86) or a nonspecific education/support (EDU) comparator']","['psychological flexibility (Acceptance and Action Questionnaire-II) or use of emotion regulation strategies (Emotion Regulation Questionnaire', 'cognitive flexibility, psychological flexibility, emotion regulation strategies, IBS symptom severity, quality of life (QOL), and distress', 'GI sympton improvement', 'Cognitive flexibility', 'IBS symptom severity, abdominal pain, and IBS QOL', 'cognitive flexibility', 'cognitive flexibility, GI symptoms (e.g., abdominal pain), and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]",130.0,0.0475391,"For CBT patients, changes in cognitive flexibility were significantly associated with changes in IBS symptom severity, abdominal pain, and IBS QOL.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Lackner', 'Affiliation': 'Division of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, ECMC, 462 Grider St., Buffalo, NY, 14215, USA. Electronic address: lackner@buffalo.edu.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Gudleski', 'Affiliation': 'Division of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, ECMC, 462 Grider St., Buffalo, NY, 14215, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Radziwon', 'Affiliation': 'Division of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, ECMC, 462 Grider St., Buffalo, NY, 14215, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Krasner', 'Affiliation': 'Division of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, ECMC, 462 Grider St., Buffalo, NY, 14215, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Firth', 'Affiliation': 'Division of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, ECMC, 462 Grider St., Buffalo, NY, 14215, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Naliboff', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, Division of Digestive Diseases, University of California, Los Angeles, CA, 90095-7378, USA.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Vargovich', 'Affiliation': 'Division of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, ECMC, 462 Grider St., Buffalo, NY, 14215, USA.'}, {'ForeName': 'Ashlye B', 'Initials': 'AB', 'LastName': 'Borden', 'Affiliation': 'Division of Behavioral Medicine, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, ECMC, 462 Grider St., Buffalo, NY, 14215, USA.'}, {'ForeName': 'Emeran A', 'Initials': 'EA', 'LastName': 'Mayer', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, Division of Digestive Diseases, University of California, Los Angeles, CA, 90095-7378, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2022.104033']
1302,35653917,Simulation of CAD/CAM milling on lithium disilicate: Mechanical and topographic analyses of surface grinding different protocols.,"The aim of this study was to evaluate the topography and the fatigue performance of lithium disilicate glass-ceramic after surface grinding through different laboratory protocols used to simulate the Computer-aided design/Computer-aided manufacturing (CAD/CAM) milling. Ceramic discs (IPS e.max CAD, Ø = 13.5 mm × 1.2 mm of thickness) were produced through different methodologies: milling in CAD/CAM system (CAD/CAM group); produced in-lab with a polished surface (POL group); or produced through in-lab methods and randomly distributed into five groups according to different grinding protocols to simulate the CAD/CAM milling [grinding with a CAD/CAM bur coupled to a mandrel (CAD/CAM Bur group); fine diamond bur using oscillatory movements (DBO group); fine diamond bur in x and y axes of the disc (DBXY group); #60-grit silicon carbide sandpaper (SiC group); and #60-grit wood sandpaper (WS group)]. The specimens were fatigue tested (n = 15) according to the step-stress method (initial load: 60 N; step-size: 20 N; 10,000 cycles/step; 20 Hz frequency). A roughness analysis was performed on all specimens, while fractal dimension (FD) and fractography were performed on representative samples. The Kaplan-Meier analysis showed that the POL (293.3 N) group presented better fatigue performance (higher load and number of cycles for failure) (p < 0.05) than the other groups (CAD/CAM = 222.7 N; CAD/CAM Bur = 181.3 N; DBO = 184.0 N; DBXY = 192.0 N; SiC = 182.6 N; WS = 182.6 N). For roughness, only the SiC (Ra = 1.616; Rz = 10.465) and WS (Ra = 1.673; Rz = 10.655) groups produced statistically similar Ra (μm) and Rz (μm) values to the CAD/CAM (Ra = 1.628; Rz = 9.571) group (p > 0.05). The surface created by CAD/CAM milling and POL group exhibited more complexity (FD) higher values than the experimental groups. For the ceramic surface topography images, the CAD/CAM milling visibly produced a uniform surface compared to the other groups; however, the POL group was the smoothest. The DBO, DBXY, SiC, and WS groups resulted in similar characteristics of surface topography. Therefore, although the SiC and WS groups showed similar roughness to the control group (CAD/CAM), no in-lab simulation method was fully capable to mimic the mechanical performance of the CAD/CAM-milled lithium disilicate glass-ceramic.",2022,"For the ceramic surface topography images, the CAD/CAM milling visibly produced a uniform surface compared to the other groups; however, the POL group was the smoothest.","['182.6', '222.7']","['lithium disilicate glass-ceramic', 'CAD/CAM milling [grinding with a CAD/CAM bur coupled to a mandrel (CAD/CAM Bur group); fine diamond bur using oscillatory movements (DBO group); fine diamond bur in x and y axes of the disc (DBXY group); #60-grit silicon carbide sandpaper (SiC group); and #60-grit wood sandpaper', 'Ceramic discs (IPS e.max CAD, Ø\xa0']","['fatigue performance', 'Ra (μm) and Rz (μm) values to the CAD/CAM']",[],"[{'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0162516', 'cui_str': 'Computer-Assisted Manufacturing'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0440273', 'cui_str': 'Grit'}, {'cui': 'C0074523', 'cui_str': 'Silicon carbide'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0162516', 'cui_str': 'Computer-Assisted Manufacturing'}]",,0.0542129,"For the ceramic surface topography images, the CAD/CAM milling visibly produced a uniform surface compared to the other groups; however, the POL group was the smoothest.","[{'ForeName': 'Gabriela Carrão', 'Initials': 'GC', 'LastName': 'Aragonez', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: gabriela_aragonez@outlook.com.'}, {'ForeName': 'Rafaela Oliveira', 'Initials': 'RO', 'LastName': 'Pilecco', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: rafaela-pilecco@hotmail.com.'}, {'ForeName': 'Kiara Serafini', 'Initials': 'KS', 'LastName': 'Dapieve', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: kiara_s_d@hotmail.com.'}, {'ForeName': 'Thiago Augusto Lima', 'Initials': 'TAL', 'LastName': 'Burgo', 'Affiliation': 'Department of Physics, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: thiago.burgo@ufsm.br.'}, {'ForeName': 'Luís Felipe', 'Initials': 'LF', 'LastName': 'Guilardi', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: luisfguilardi@hotmail.com.'}, {'ForeName': 'Catina', 'Initials': 'C', 'LastName': 'Prochnow', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: catinaprochnow@hotmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}, {'ForeName': 'Marília Pivetta', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: mariliarip@hotmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2022.105278']
1303,35653789,"The dienogest-related cystitis in women with endometriosis: a prospective, controlled, comparative study.","The aim of the study was to examine the severity of clinical symptoms of acute cystitis and the level bacteriuria in female patients who underwent to laparoscopic surgery followed by a postoperative administration of dienogest 2 mg and combined oral contraceptives pills (COCP). One hundred and forty five women who had a laparoscopic surgery prospectively were enrolled. Criteria inclusions were the age from 30 to 45 years old; body mass index (BMI) absence of previous hormonal therapy at least 6 month and recent performed a laparoscopy surgery for endometriosis. The women ( n  = 35) who had uterine myoma, abnormal coagulation profile; concomitant neoplastic diseases; chronic pelvic inflammatory disease and chronic recurrent cystitis were excluded from study. The female patients were assigned into both groups treatment: group I ( n  = 54) and group II (control,  n  = 56) who received dienogest 2 mg once daily and COCP, respectively. During follow-up three female patients of group I were withdrawn due to prolonged genital bleedings. The final analysis included 105 women. The patients of both groups had a low level of bacteriuria <10 3  CFU/ml without clinical symptoms of acute cystitis before treatment. The level of bacteriuria in-group I significantly increased from 10 2  to 10 6  CFU/ml whereas in-group II did not exceed 10 2  CFU/ml during 4 weeks of hormonal treatment. The differences of values of acute cystitis symptom score (ACSS) for differential, typical, quality of life domains were statistically significant after 4, 8 and 12 weeks of therapy in-group I compared with group II. During 3 months of hormonal treatment with dienogest 2 mg in group I, the acute cystitis developed in 10 (18.5%), in 19 (38%) and in 34 (68%) women at 4, 8 and 12 weeks of follow-up, respectively. All cases of acute cystitis in-group I were successfully treated with fosfomycin trometamol 3 g single dose or nitrofurantoin 50 mg four times a day during 5 days. We concluded that the dienogest might increase the level bacteriuria and severity of clinical symptoms of acute cystitis during a postoperative prophylaxis of endometriosis.Impact statement What is already known on this subject?  Dienogest is a 19-nortestosterone derivative progestogen that is highly selective for progesterone receptors with high efficacy for reducing endometriosis-related pelvic pain syndrome. The administration of dienogest is a standard treatment option after laparoscopic excision of endometrial heterotopic tissue with prophylactic purpose. However, there are some adverse events, which are a cause for discontinuation. What do the results of this study add?  Despite the low incidence of urinary tract infection (1-5.4%) reported in different studies this study has shown that there was a significant increase of level bacteriuria and severity of clinical symptoms of cystitis in the dienogest group. What are the implications of these findings for clinical practice and/or further research?  The implications of these findings are that the administration of dienogest may lead to enhancing of clinical symptoms of cystitis and increasing bacteriuria in some women after operative treatment of endometriosis.",2022,All cases of acute cystitis in-group I were successfully treated with fosfomycin trometamol 3 g single dose or nitrofurantoin 50 ,"['female patients who underwent to', 'female patients', 'One hundred and forty five women who had a laparoscopic surgery prospectively were enrolled', 'Criteria inclusions were the age from 30 to 45\u2009years old; body mass index (BMI) absence of previous hormonal therapy at least 6\u2009month and recent performed a laparoscopy surgery for endometriosis', '105 women', 'women with endometriosis', 'women ( n \u2009=\u200935) who had uterine myoma, abnormal coagulation profile; concomitant neoplastic diseases; chronic pelvic inflammatory disease and chronic recurrent cystitis']","['nitrofurantoin 50', 'fosfomycin trometamol', 'dienogest 2\u2009mg once daily and COCP', 'laparoscopic surgery followed by a postoperative administration of dienogest 2\u2009mg and combined oral contraceptives pills (COCP']","['level of bacteriuria', 'low level of bacteriuria', 'values of acute cystitis symptom score (ACSS) for differential, typical, quality of life domains', 'acute cystitis', 'prolonged genital bleedings', 'level bacteriuria and severity of clinical symptoms of acute cystitis', 'level bacteriuria and severity of clinical symptoms of cystitis', 'urinary tract infection']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0375576', 'cui_str': 'Abnormal coagulation profile'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0149960', 'cui_str': 'Chronic pelvic inflammatory disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0581366', 'cui_str': 'Recurrent cystitis'}]","[{'cui': 'C0028156', 'cui_str': 'Nitrofurantoin'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0041175', 'cui_str': 'Tromethamine'}, {'cui': 'C1368405', 'cui_str': 'dienogest 2 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004659', 'cui_str': 'Bacteriuria'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0149523', 'cui_str': 'Acute cystitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0854381', 'cui_str': 'Genital haemorrhage'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]",145.0,0.0408282,All cases of acute cystitis in-group I were successfully treated with fosfomycin trometamol 3 g single dose or nitrofurantoin 50 ,"[{'ForeName': 'Denis V', 'Initials': 'DV', 'LastName': 'Krakhotkin', 'Affiliation': 'Central District Hospital, Outpatient Clinic, Kamenolomni, Russia.'}, {'ForeName': 'Maria N', 'Initials': 'MN', 'LastName': 'Silkina', 'Affiliation': 'Department of Gynecology, Emergency City Hospital, Rostov-on-Don, Russia.'}, {'ForeName': 'Volodymyr A', 'Initials': 'VA', 'LastName': 'Chernylovskyi', 'Affiliation': 'Department of Urology 1, City Clinical Hospital № 4, Dnipro, Ukraine.'}, {'ForeName': 'Svetlana A', 'Initials': 'SA', 'LastName': 'Gayvoronskaya', 'Affiliation': 'Department of Bacteriology, Central District Hospital, Kamenolomni, Russia.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2022.2081492']
1304,35654771,Changes in adiponectin:leptin ratio among older adults with obesity following a 12-month exercise and diet intervention.,"BACKGROUND


Excess adiposity is characterized by alterations in adipokine secretion such that circulating leptin concentrations are increased with reductions in adiponectin. An emerging biomarker for the assessment of this adipose tissue (AT) dysfunction is the adiponectin:leptin (AL) ratio. A low AL ratio may be suggestive of dysfunctional AT and, consequently, a heightened cardiometabolic disease risk. This ancillary study investigated the relationship between the AL ratio and cardiometabolic health among community-dwelling older adults with obesity, as well as the effects of a 12-month exercise and diet intervention on changes in the AL ratio.
METHODS


Participants (n = 163, 70.2 ± 4.7 years, 38.0% male) were randomized to the exercise only group, exercise + nutrient-dense weight maintenance group (exercise + weight maintenance), or exercise + nutrient-dense caloric restriction of 500 kcal/d group (exercise + intentional weight loss) (clinicaltrials.gov #NCT00955903). Total and regional adiposity as determined by magnetic resonance imaging (MRI) and dual-energy X-ray absorptiometry (DXA), anthropometrics, and cardiometabolic biomarkers were assessed at baseline and 12 months.
RESULTS


The AL ratio was significantly (p < 0.05) inversely correlated with body mass index, waist circumference, measures of adiposity, and insulin among all participants at baseline. Among females only, significant positive and inverse correlations were also observed between this ratio and high-density lipoprotein cholesterol and the inflammatory biomarkers high sensitivity C-reactive protein and interleukin-6, respectively. While controlling for biological sex, a significant time by intervention group interaction effect (p < 0.05) was observed such that the AL ratio significantly increased from baseline to study completion among participants in the exercise + weight maintenance group and exercise + intentional weight loss group. Post hoc analysis revealed that the exercise + intentional weight loss group exhibited a significantly greater AL ratio at study completion compared to other groups (p < 0.05 all).
CONCLUSIONS


Results are in support of the AL ratio as a measure of AT dysfunction among older adults. Furthermore, results suggest that a 12-month exercise and diet intervention with intentional weight loss assists in improving the AL ratio in this population.",2022,"While controlling for biological sex, a significant time by intervention group interaction effect (p < 0.05) was observed such that the AL ratio significantly increased from baseline to study completion among participants in the exercise + weight maintenance group and exercise + intentional weight loss group.","['older adults with obesity following a 12-month exercise and diet intervention', 'Participants (n\u2009=\u2009163, 70.2\u2009±\u20094.7 years, 38.0% male', 'community-dwelling older adults with obesity', 'older adults']","['exercise and diet intervention', 'exercise only group, exercise\u2009+\u2009nutrient-dense weight maintenance group (exercise\u2009+\u2009weight maintenance), or exercise\u2009+\u2009nutrient-dense caloric restriction of 500\u2009kcal/d group (exercise\u2009+\u2009intentional weight loss']","['Total and regional adiposity as determined by magnetic resonance imaging (MRI) and dual-energy X-ray absorptiometry (DXA), anthropometrics, and cardiometabolic biomarkers', 'body mass index, waist circumference, measures of adiposity, and insulin', 'adiponectin:leptin ratio', 'AL ratio and cardiometabolic health', 'AL ratio', 'ratio and high-density lipoprotein cholesterol']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",,0.0482221,"While controlling for biological sex, a significant time by intervention group interaction effect (p < 0.05) was observed such that the AL ratio significantly increased from baseline to study completion among participants in the exercise + weight maintenance group and exercise + intentional weight loss group.","[{'ForeName': 'Katelyn E', 'Initials': 'KE', 'LastName': 'Senkus', 'Affiliation': 'Department of Human Nutrition, The University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'Kristi M', 'Initials': 'KM', 'LastName': 'Crowe-White', 'Affiliation': 'Department of Human Nutrition, The University of Alabama, Tuscaloosa, AL, USA. kcrowe@ches.ua.edu.'}, {'ForeName': 'Anneliese C', 'Initials': 'AC', 'LastName': 'Bolland', 'Affiliation': 'College of Communication and Information Sciences, Communication Studies & Institute for Communication and Information Research, The University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Locher', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jamy D', 'Initials': 'JD', 'LastName': 'Ard', 'Affiliation': 'Wake Forest University School of Medicine, Department of Epidemiology and Prevention, Winston-Salem, NC, USA.'}]",Nutrition & diabetes,['10.1038/s41387-022-00207-1']
1305,35655483,Psychological Nursing Effect of Patients with Gynecological Malignant Tumor.,"Objective


To analyze the psychological nursing effect of patients with gynecological malignant tumor.
Method


A total of 104 patients with gynecological malignant tumor receiving chemotherapy in our hospital from December 2019 to November 2020 were selected and randomly divided into observation group and control group with 52 cases each. Patients in the control group were treated with routine nursing of gynecological malignant tumor chemotherapy. The observation group applied psychological nursing methods on the basis of the control group, and psychological status, quality of sleep, quality of life, treatment coordination, and adverse reactions were compared between the two groups.
Results


There was no difference in anxiety and depression scores ( P  > 0.05), the postintervention score was lower than the preintervention score, and the reduction was more significant in the observation group ( P  < 0.05). After intervention, PSQI scores of the two groups of subjects were significantly lower than before intervention ( P  < 0.05), subjects in the observation group were significantly lower than those in the control group, and the difference was statistically significant ( P  < 0.05). After intervention, the total score of FACT-B scale was significantly higher in the observation group than in the control group, and the difference was statistically significant ( P  < 0.05). After the implementation of psychological nursing, the degree of tumor treatment cooperation of observation group was higher than the control group ( P  < 0.05). After intervention, there was no statistically significant difference in hematology, allergic reaction, or hair loss between the two groups ( P  > 0.05). The incidence of gastrointestinal and neurological adverse events in the observation group was significantly lower than that in the control group, and the difference was statistically significant ( P  < 0.05).
Conclusion


The psychological state of patients with gynecological malignant tumor mainly included anxiety and terror and so on. Through psychological counseling, it could effectively alleviate the abovementioned bad psychology, improve the cooperation of patients with tumor treatment, and reduce the occurrence of patients' adverse reactions.",2022,"After intervention, the total score of FACT-B scale was significantly higher in the observation group than in the control group, and the difference was statistically significant ( P  < 0.05).","['patients with gynecological malignant tumor mainly included anxiety and terror and so on', 'patients with gynecological malignant tumor', '104 patients with gynecological malignant tumor receiving chemotherapy in our hospital from December 2019 to November 2020', 'Patients with Gynecological Malignant Tumor']",['routine nursing of gynecological malignant tumor chemotherapy'],"['hematology, allergic reaction, or hair loss', 'incidence of gastrointestinal and neurological adverse events', 'PSQI scores', 'total score of FACT-B scale', 'anxiety and depression scores', 'psychological status, quality of sleep, quality of life, treatment coordination, and adverse reactions', 'postintervention score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",104.0,0.0115134,"After intervention, the total score of FACT-B scale was significantly higher in the observation group than in the control group, and the difference was statistically significant ( P  < 0.05).","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Lianyungang, 222001, China.""}, {'ForeName': 'Xitao', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""The First People's Hospital of Lianyungang, 222001, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': ""The First People's Hospital of Lianyungang, 222001, China.""}]",BioMed research international,['10.1155/2022/1569656']
1306,35634931,"Efficacy of conventional-dose cytarabine, idarubicin and thioguanine versus intermediate-dose cytarabine and idarubicin in the induction treatment of acute myeloid leukemia: Long-term results of the prospective randomized nationwide AML-2003 study by the Finnish Leukemia Group.","OBJECTIVES


AML-2003 study sought to compare the long-term efficacy and safety of IAT and IdAraC-Ida in induction chemotherapy of acute myeloid leukemia (AML) and introduce the results of an integrated genetic and clinical risk classification guided treatment strategy.
METHODS


Patients were randomized to receive either IAT or IdAraC-Ida as the first induction treatment. Intensified postremission strategies were employed based on measurable residual disease (MRD) and risk classification. Structured questionnaire forms were used to gather data prospectively.
RESULTS


A total of 356 AML patients with a median age of 53 years participated in the study. Long-term overall survival (OS) and relapse-free survival (RFS) were both 49% at 10 years. The median follow-up was 114 months. No significant difference in remission rate, OS or RFS was observed between the two induction treatments. Risk classification according to the protocol, MRD after the first and the last consolidation treatment affected the OS and RFS significantly (p < .001).
CONCLUSIONS


Intensified cytarabine dose in the first induction treatment was not better than IAT in patients with AML. Intensification of postremission treatment in patients with clinical risk factors or MRD seems reasonable, but randomized controlled studies are warranted in the future.",2022,Long term overall survival (OS) and relapse-free survival (RFS) were both 49 % at 10 years.,"['Finnish Leukemia Group', 'Patients', 'patients with AML', 'patients with clinical risk factors or MRD', 'acute myeloid leukemia (AML', '356 AML patients with a median age of 53\u2009years participated in the study']","['IAT or IdAraC-Ida', 'conventional-dose cytarabine, idarubicin and thioguanine (IAT) versus intermediate-dose cytarabine and idarubicin (IdAraC-Ida', 'IAT and IdAraC-Ida', 'cytarabine']","['OS and RFS', 'remission rate, OS or RFS', 'overall survival (OS) and relapse-free survival (RFS']","[{'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0969832', 'cui_str': 'Idarac'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0039902', 'cui_str': 'Thioguanine'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",356.0,0.0387391,Long term overall survival (OS) and relapse-free survival (RFS) were both 49 % at 10 years.,"[{'ForeName': 'Aarne', 'Initials': 'A', 'LastName': 'Kolonen', 'Affiliation': 'Department of Internal Medicine, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Marjatta', 'Initials': 'M', 'LastName': 'Sinisalo', 'Affiliation': 'Department of Internal Medicine, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Rimpiläinen', 'Affiliation': 'Department of Internal Medicine, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Hannele', 'Initials': 'H', 'LastName': 'Rintala', 'Affiliation': 'Department of Internal Medicine, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Sankelo', 'Affiliation': 'Department of Internal Medicine, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Koivunen', 'Affiliation': 'Department of Internal Medicine, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Raija', 'Initials': 'R', 'LastName': 'Silvennoinen', 'Affiliation': 'Department of Internal Medicine, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Räty', 'Affiliation': 'Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Ruutu', 'Affiliation': 'Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Volin', 'Affiliation': 'Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Porkka', 'Affiliation': 'Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Esa', 'Initials': 'E', 'LastName': 'Jantunen', 'Affiliation': 'Department of Medicine, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Nousiainen', 'Affiliation': 'Department of Medicine, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Taru', 'Initials': 'T', 'LastName': 'Kuittinen', 'Affiliation': 'Department of Medicine, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Karri', 'Initials': 'K', 'LastName': 'Penttilä', 'Affiliation': 'Department of Medicine, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Pyörälä', 'Affiliation': 'Department of Medicine, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Säily', 'Affiliation': 'Department of Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Koistinen', 'Affiliation': 'Department of Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Marjut', 'Initials': 'M', 'LastName': 'Kauppila', 'Affiliation': 'Stem Cell Transplantation Unit, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Itälä-Remes', 'Affiliation': 'Stem Cell Transplantation Unit, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Ollikainen', 'Affiliation': 'Department of Medicine, Satakunta Central Hospital, Pori, Finland.'}, {'ForeName': 'Auvo', 'Initials': 'A', 'LastName': 'Rauhala', 'Affiliation': 'The Faculty of Education and Welfare Studies, Department of Health Sciences, Åbo Akademi University, Vaasa, Finland.'}, {'ForeName': 'Veli', 'Initials': 'V', 'LastName': 'Kairisto', 'Affiliation': 'Laboratory of Molecular Haematology and Pathology, Turku University Central Hospital, Turku, Finland.'}, {'ForeName': 'Tarja-Terttu', 'Initials': 'TT', 'LastName': 'Pelliniemi', 'Affiliation': 'Department of Clinical Chemistry, University of Turku, Finland and Fimlab Laboratories Ltd, Tampere, Finland.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Elonen', 'Affiliation': 'Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of haematology,['10.1111/ejh.13805']
1307,35634887,3D laparoscopic prostatectomy: results of multicentre study.,"INTRODUCTION


Three-dimensional laparoscopic prostatectomy (3D LRP) is a potentially cost-effective option for robot-assisted laparoscopic prostatectomy (RALP). Results for two-dimensional LRP and RALP are well documented; however, little has been published on the outcomes of 3D LRP. Our objective was to report the perioperative and short-term results of 3D LRP in a multicentre study.
MATERIALS AND METHODS


In total, 496 unselected men with prostate cancer underwent 3D LRP by three surgeons between December 2013 and December 2018. Median age was 64 (43-76) years. Median prostate-specific antigen (PSA) was 7.9 (0.7-148) ng/ml. Preoperative and perioperative data and complications according to the Clavien-Dindo classification were collected. PSA and continence results were reported at 3 and 12 months postoperatively. Data were analysed with IBM SPSS statistics (25).
RESULTS


Pathological Gleason score was 6 in 29%, 7 in 55.4%, 8 in 9.1%, 9 in 5.2% and 10 in 1.2% of patients. Pathological tumour classification was T2c in 59.5%, T3a in 19.5% and T3b in 10.9% of cases. Positive surgical margins occurred in 27.2%. Lymphadenectomy was performed in 36.3%, with positive lymph nodes in 11.8%. Median operative time was 137 (78-334) min and median blood loss 200 (10-1100) ml. Clavien-Dindo IIIa and IIIb complications occurred in 6.9% and 1.6%, respectively. At 3 and 12 months postoperatively, 90.2% and 91.4% of patients, respectively, had PSA <0.2 ng/ml, while 77.1% and 87.7% of patients were completely dry or using a maximum of one pad daily.
CONCLUSIONS


3D LRP shows promising results, comparable to similar studies published on RALP.",2022,"Clavien-Dindo IIIa and IIIb complications occurred in 6.9% and 1.6%, respectively.","['496 unselected men with prostate cancer underwent 3D LRP by three surgeons between December 2013 and December 2018', 'Median age was 64 (43-76) years']","['dimensional laparoscopic prostatectomy (3D LRP', '3D laparoscopic prostatectomy', 'Lymphadenectomy', 'robot-assisted laparoscopic prostatectomy (RALP']","['Pathological tumour classification', 'Median prostate-specific antigen (PSA', 'Positive surgical margins', 'Pathological Gleason score', 'Median operative time', 'Clavien-Dindo IIIa and IIIb complications', 'PSA and continence results']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1301142', 'cui_str': 'WHO tumor classification'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",496.0,0.144061,"Clavien-Dindo IIIa and IIIb complications occurred in 6.9% and 1.6%, respectively.","[{'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Haapiainen', 'Affiliation': 'Department of Urology, The Hospital District of South Ostrobothnia, Seinäjoki, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Kaipia', 'Affiliation': 'Department of Urology, TAYS Cancer Centre, Tampere, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Murtola', 'Affiliation': 'Department of Urology, TAYS Cancer Centre, Tampere, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Seikkula', 'Affiliation': 'Department of Urology, Central Finland Health Care District, Jyväskylä, Finland.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Seppänen', 'Affiliation': 'Department of Urology, Satakunta Hospital District, Pori, Finland.'}, {'ForeName': 'Pyry', 'Initials': 'P', 'LastName': 'Jämsä', 'Affiliation': 'Department of Urology, TAYS Cancer Centre, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Raitanen', 'Affiliation': 'Department of Urology, The Hospital District of South Ostrobothnia, Seinäjoki, Finland.'}]",Scandinavian journal of urology,['10.1080/21681805.2022.2075458']
1308,35636174,Parent-administered pediatric Tuina for attention deficit/hyperactivity disorder symptoms in preschool children: A pilot randomized controlled trial embedded with a process evaluation.,"BACKGROUND


Beneficial effects of parent-administered pediatric tuina on ADHD in children have been reported in previous studies, but no rigorously designed randomized controlled trials (RCTs) have been conducted on it.
OBJECTIVE


To assess the feasibility and preliminary effects of parent-administered pediatric tuina for ADHD symptoms in preschoolers.
METHODS


This project was a two-arm, parallel, open-label, pilot RCT. Sixty-four participants were randomized into two groups at a 1:1 ratio. Parents in the parent-administered tuina group (n = 32) attended an online training program on pediatric tuina for ADHD and conduct this intervention on their children at home. Parents in the parent-child interaction group (n = 32) attended an online training about progressive muscle relaxation exercise and carried out parent-child interactive physical activities with their children at home. Both interventions were carried out every other day during a two-month intervention period, with each manipulation for at least 20 min. Feasibility outcomes included recruitment rate, consent rate, participants' adherence, retention rate, and adverse event. Outcomes were assessed at baseline, week 4, and week 8. The primary outcome measure was the Swanson, Nolan, and Pelham parent scale (SNAP); the secondary outcomes included preschool anxiety scale, children's sleep habits questionnaire, and parental stress scale. A mixed-method process evaluation embedded within the outcome evaluation was performed.
RESULTS


The recruitment rate was 12.8 per month. The consent rate was 98.5%. Good adherence was shown from the parent logbook. Four participants withdraw from the study. No severe adverse event was reported. For the SNAP total score, both groups showed improvement with moderate within-group effect size (Cohen's d > 0.5, all p < 0.001) and the between-group effect size was minimal (d ppc2 < 0.2, p > 0.05). Perceived improvements on children's appetite and sleep quality, and parent-child relationship was observed from the qualitative data.
CONCLUSIONS


The study design and the parent-administered pediatric tuina intervention were feasible. Parent-administered pediatric tuina provided beneficial effects on improving core hyperactivity/impulsivity symptoms in preschool children. Parents perceived improvements on children's appetite and sleep quality. Further large-scale are warranted.",2022,No severe adverse event was reported.,"['preschoolers', 'preschool children', 'Sixty-four participants']","['online training about progressive muscle relaxation exercise and carried out parent-child interactive physical activities with their children at home', 'online training program on pediatric tuina for ADHD and conduct this intervention', 'parent-administered pediatric tuina']","['severe adverse event', 'consent rate', ""children's appetite and sleep quality, and parent-child relationship"", ""recruitment rate, consent rate, participants' adherence, retention rate, and adverse event"", ""Swanson, Nolan, and Pelham parent scale (SNAP); the secondary outcomes included preschool anxiety scale, children's sleep habits questionnaire, and parental stress scale"", 'recruitment rate', ""children's appetite and sleep quality"", 'SNAP total score']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.103904,No severe adverse event was reported.,"[{'ForeName': 'Shu-Cheng', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, 11 Yuk Choi Road, Hung Hom, Kowloon, HKSAR, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Yantai Aviation Medical Room, Shandong airlines, China.'}, {'ForeName': 'Hao-Sheng', 'Initials': 'HS', 'LastName': 'Wang', 'Affiliation': 'Yantai Aviation Medical Room, Shandong airlines, China.'}, {'ForeName': 'Dong-Dong', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': ""Children's Massage Center, Shandong University of Traditional Chinese Medicine Affiliated Hospital, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Yantai Aviation Medical Room, Shandong airlines, China.'}, {'ForeName': 'Hui-Lin', 'Initials': 'HL', 'LastName': 'Cheng', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, 11 Yuk Choi Road, Hung Hom, Kowloon, HKSAR, China.'}, {'ForeName': 'Lorna Kwai-Ping', 'Initials': 'LK', 'LastName': 'Suen', 'Affiliation': 'School of Nursing, Tung Wah College, HKSAR, China.'}, {'ForeName': 'Wing-Fai', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, 11 Yuk Choi Road, Hung Hom, Kowloon, HKSAR, China. Electronic address: jerry-wf.yeung@polyu.edu.hk.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2022.154191']
1309,35636634,Naturalistic stimuli reveal a sensitive period in cross modal responses of visual cortex: Evidence from adult-onset blindness.,"How do life experiences impact cortical function? In people who are born blind, the ""visual"" cortices are recruited during nonvisual tasks, such as Braille reading and sound localization. Do visual cortices have a latent capacity to respond to nonvisual information throughout the lifespan? Alternatively, is there a sensitive period of heightened plasticity that makes visual cortex repurposing especially possible during childhood? To gain insight into these questions, we leveraged meaningful naturalistic auditory stimuli to simultaneously engage a broad range of cognitive domains and quantify cross-modal responses across congenitally blind (n = 22), adult-onset blind (vision loss >18 years-of-age, n = 14) and sighted (n = 22) individuals. During fMRI scanning, participants listened to two types of meaningful naturalistic auditory stimuli: excerpts from movies and a spoken narrative. As controls, participants heard the same narrative with the sentences shuffled and the narrative played backwards (i.e., meaningless sounds). We correlated the voxel-wise timecourses of different participants within condition and group. For all groups, all stimulus conditions induced synchrony in auditory cortex while only the narrative stimuli synchronized responses in higher-cognitive fronto-parietal and temporal regions. As previously reported, inter-subject synchrony in visual cortices was higher in congenitally blind than sighted blindfolded participants and this between-group difference was particularly pronounced for meaningful stimuli (movies and narrative). Critically, visual cortex synchrony was no higher in adult-onset blind than sighted blindfolded participants and did not increase with blindness duration. Sensitive period plasticity enables cross-modal repurposing in visual cortices.",2022,"For all groups, all stimulus conditions induced synchrony in auditory cortex while only the narrative stimuli synchronized responses in higher-cognitive fronto-parietal and temporal regions.","['18 years-of-age, n\u202f=\u202f14) and sighted (n\u202f=\u202f22) individuals', 'visual cortex: Evidence from adult-onset blindness']",[],"['adult-onset blind (vision loss', 'visual cortices', 'blindness duration', 'visual cortex synchrony']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",22.0,0.0657317,"For all groups, all stimulus conditions induced synchrony in auditory cortex while only the narrative stimuli synchronized responses in higher-cognitive fronto-parietal and temporal regions.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Musz', 'Affiliation': 'Department of Psychological and Brain Sciences, Johns Hopkins University, Baltimore, MD, USA. Electronic address: emusz1@jhu.edu.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Loiotile', 'Affiliation': 'Department of Psychological and Brain Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological and Brain Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Rhodri', 'Initials': 'R', 'LastName': 'Cusack', 'Affiliation': 'Trinity College Institute of Neuroscience, School of Psychology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bedny', 'Affiliation': 'Department of Psychological and Brain Sciences, Johns Hopkins University, Baltimore, MD, USA.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2022.108277']
1310,35637354,"The Impact of Post-Thyroidectomy Neck Stretching Exercises on Neck Discomfort, Pressure Symptoms, Voice and Quality of Life: A Randomized Controlled Trial.","BACKGROUND


Following surgery for benign nodular goiter, patients may experience neck and shoulder pain, neck pressure and tightness, choking sensation, altered voice function, and dysphagia leading to decreased short-term quality of life (QoL). This single-blinded randomized controlled trial investigated the effect of post-thyroidectomy rehabilitative neck stretching and movement exercises on these variables including QoL.
METHODS


Patients undergoing thyroid lobectomy or total thyroidectomy were randomized to perform neck stretching and movement exercises three times daily in four weeks following surgery (intervention group) or conventional follow-up without exercises (control group). Outcome measures were scores in the following questionnaires: Disease-specific Thyroid-Related Patient-Reported Outcome (ThyPRO-39) involving symptoms of ""sense of fullness in the neck,"" ""pressure in the throat,"" and ""discomfort swallowing"" combined in the multi-item Goiter Symptom Scale, the Voice Handicap-Index-10 (VHI-10), neck and shoulder pain measurement by a numeric rating scale (NRS), and General measure of health (EQ-5D-5L). All scores were assessed prior to surgery and one, two, four weeks, and three months after surgery. Data were analyzed using a linear mixed model.
RESULTS


Eighty-nine patients were included and randomized to the control (n = 45) or the intervention group (n = 44). At three months after surgery, both the control and the intervention group experienced large to moderate improvements in the Goiter symptom and Hyperthyroid symptom scale of the ThyPRO questionnaire (p < 0.004). No significant between-group differences were found in any of the other applied scales.
CONCLUSIONS


This study confirms that patients experience profound improvements in QoL after surgery for benign nodular goiter. However, early post-thyroidectomy neck stretching and movement exercises did not result in further QoL improvement, reduction in pain or less impacted subjective voice function for patients primarily undergoing thyroid lobectomy. Trial Registration Number NCT04645056 ( https://clinicaltrials.gov ).",2022,"At three months after surgery, both the control and the intervention group experienced large to moderate improvements in the Goiter symptom and Hyperthyroid symptom scale of the ThyPRO questionnaire (p < 0.004).","['patients primarily undergoing thyroid lobectomy', 'Patients undergoing thyroid lobectomy or total thyroidectomy', 'Eighty-nine patients']","['neck stretching and movement exercises three times daily in four weeks following surgery (intervention group) or conventional follow-up without exercises (control group', 'Post-Thyroidectomy Neck Stretching Exercises', 'post-thyroidectomy rehabilitative neck stretching and movement exercises']","['QoL', 'questionnaires: Disease-specific Thyroid-Related Patient-Reported Outcome (ThyPRO-39) involving symptoms of ""sense of fullness in the neck,"" ""pressure in the throat,"" and ""discomfort swallowing"" combined in the multi-item Goiter Symptom Scale, the Voice Handicap-Index-10 (VHI-10), neck and shoulder pain measurement by a numeric rating scale (NRS), and General measure of health (EQ-5D-5L', 'QoL improvement, reduction in pain', 'Neck Discomfort, Pressure Symptoms, Voice and Quality of Life', 'Goiter symptom and Hyperthyroid symptom scale of the ThyPRO questionnaire', 'subjective voice function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0556818', 'cui_str': 'Neck stretching'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018021', 'cui_str': 'Goiter'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0863104', 'cui_str': 'Neck discomfort'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0020550', 'cui_str': 'Hyperthyroidism'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",89.0,0.156942,"At three months after surgery, both the control and the intervention group experienced large to moderate improvements in the Goiter symptom and Hyperthyroid symptom scale of the ThyPRO questionnaire (p < 0.004).","[{'ForeName': 'Rikke Taudal', 'Initials': 'RT', 'LastName': 'Thorsen', 'Affiliation': 'Department of ORL-Head & Neck Surgery and Audiology, Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense C, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Døssing', 'Affiliation': 'Department of ORL-Head & Neck Surgery and Audiology, Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense C, Denmark.'}, {'ForeName': 'Steen Joop', 'Initials': 'SJ', 'LastName': 'Bonnema', 'Affiliation': 'Faculty of Health Sciences, Institute of Clinical Research, University of Southern Denmark, Denmark Winsløws Vej 4, 5000, Odense C, Denmark.'}, {'ForeName': 'Thomas Heiberg', 'Initials': 'TH', 'LastName': 'Brix', 'Affiliation': 'Faculty of Health Sciences, Institute of Clinical Research, University of Southern Denmark, Denmark Winsløws Vej 4, 5000, Odense C, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Godballe', 'Affiliation': 'Department of ORL-Head & Neck Surgery and Audiology, Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense C, Denmark.'}, {'ForeName': 'Jesper Roed', 'Initials': 'JR', 'LastName': 'Sorensen', 'Affiliation': 'Department of ORL-Head & Neck Surgery and Audiology, Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense C, Denmark. jesper.roed.sorensen@rsyd.dk.'}]",World journal of surgery,['10.1007/s00268-022-06610-0']
1311,35638317,"The effect of duloxetine on mechanistic pain profiles, cognitive factors and clinical pain in patients with painful knee osteoarthritis-A randomized, double-blind, placebo-controlled, crossover study.","BACKGROUND


Duloxetine is indicated in the management of pain in osteoarthritis. Evidence suggests that duloxetine modulates central pain mechanisms and cognitive factors, and these factors are assumed contributing to the analgesic effect. This proof-of-mechanism, randomized, placebo-controlled, crossover, double-blinded trial evaluated the effect of duloxetine on quantitative sensory testing (QST), cognitive factors and clinical pain in patients with osteoarthritis and to predict the analgesic effect.
METHODS


Twenty-five patients completed this cross-over study with either 18-week duloxetine (maximum 60 mg/daily) followed by placebo or vice-versa. Pressure pain thresholds, temporal summation of pain and conditioned pain modulation were assessed using cuff algometry. The Hospital Anxiety and Depression Scale and the Pain Catastrophizing Scale evaluated cognitive factors. Clinical pain was assessed using Brief Pain Inventory and Western Ontario and McMaster Universities Osteoarthritis Index. Linear regression models were used to predict the analgesic effect of duloxetine.
RESULTS


Depending on the clinical pain outcome, 40%-68% of patients were classified as responders to duloxetine. Linear regression models predicted the analgesic effect (predictive value of 45%-75% depending on clinical pain outcome parameter) using a combination of pretreatment QST parameters, cognitive factors and clinical pain. No significant changes were found for QST, cognitive factors or clinical pain on a group level when comparing duloxetine to placebo.
CONCLUSION


A combination of pretreatment QST, cognitive factors and clinical pain was able to predict the analgesic response of duloxetine. However, in this relatively small study, duloxetine did not selectively modulate QST, cognitive factors or clinical pain intensity when compared with placebo.
SIGNIFICANCE


Duloxetine is proposed as a treatment for chronic pain. Pre-clinical trials suggest that duloxetine provides analgesia through modulation of descending pain inhibitory pathways or through improvements in cognitive factors. The current study demonstrates that pretreatment mechanistic pain profiling, cognitive factors and clinical pain can predict the analgesic effect of duloxetine and that only a subset of patients might benefit from duloxetine treatment.",2022,"No significant changes were found for QST, cognitive factors, or clinical pain on a group level when comparing duloxetine to placebo.
","['Patients with Painful Knee Osteoarthritis ', 'Twenty-five patients completed this cross-over study with either 18-weeks', 'patients with osteoarthritis', 'pain in osteoarthritis']","['Duloxetine', 'duloxetine (maximum 60 mg/daily) followed by placebo or vice-versa', 'duloxetine', 'placebo', 'Placebo']","['QST, cognitive factors, or clinical pain intensity', 'Hospital Anxiety and Depression Scale and the Pain Catastrophizing Scale evaluated cognitive factors', 'Brief Pain Inventory and Western Ontario and McMaster Universities Osteoarthritis Index', 'quantitative sensory testing (QST), cognitive factors, and clinical pain', 'Pressure pain thresholds, temporal summation of pain, and conditioned pain modulation', 'Mechanistic Pain Profiles, Cognitive Factors, and Clinical Pain', 'clinical pain outcome', 'QST, cognitive factors, or clinical pain', 'Clinical pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",25.0,0.244192,"No significant changes were found for QST, cognitive factors, or clinical pain on a group level when comparing duloxetine to placebo.
","[{'ForeName': 'Kristian Kjaer-Staal', 'Initials': 'KK', 'LastName': 'Petersen', 'Affiliation': 'Center for Neuroplasticity and Pain, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Anne Estrup', 'Initials': 'AE', 'LastName': 'Olesen', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ammitzbøll', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Bertoli', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Arendt-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1988']
1312,35641440,"Effectiveness of a fluid immersion simulation system in the acute post-operative management of pressure ulcers: A prospective, randomised controlled trial.","The fluid immersion simulation system (FIS) has demonstrated good clinical applicability. This is the first study to compare surgical flap closure outcomes of FIS with an air-fluidised bed (AFB), considered as standard of care. The success of closure after 14 days post-op was the primary endpoint. Secondary endpoints were incidences of complications in the first 2 weeks after surgery and the rate of acceptability of the device. Thirty-eight subjects were in the FIS group while 42 subjects were placed in the AFB group. Flap failure rate was similar between groups (14% vs. 12%; p = 0.84). Complications, notably dehiscence and maceration, were significantly higher in the FIS group (40% vs. 17%; p = 0.0296). The addition of a microclimate regulation device (ClimateCare®) to FIS for the last 43 patients showed a significant decrease in the rate of flap failure (71% vs. 16%; p = 0.001) and incidence of complications (33% vs. 0%; p = 0.011). There was no statistically significant difference between the FIS and air-fluidised bed (AFB) in the rate of acceptability (nurse acceptance: 1.49 vs. 1.72; p = 0.8; patient acceptance: 2.08 vs. 2.06; p = 0.17), which further illustrates the potential implementation of this tool in a patient-care setting. Our results show that the use of ClimateCare® in combination with FIS can be a better alternative to the AFB in surgical closure of pressure ulcers.",2022,"Complications, notably dehiscence and maceration, were significantly higher in the FIS group (40% vs 17%; P=0.0296).","['38 subjects were in the FIS group while 42 subjects were placed in the AFB group', 'pressure ulcers']","['fluid immersion simulation system', 'Fluid Immersion Simulation system (FIS', 'FIS with an Air-Fluidized Bed (AFB']","['rate of acceptability', 'incidence of complications', 'rate of flap failure', 'incidences of complications', 'Complications, notably dehiscence and maceration', 'success of closure', 'FIS and AFB', 'rate of acceptability of the device', 'Flap failure rate']","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0179267', 'cui_str': 'Air-fluidized bed'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0179267', 'cui_str': 'Air-fluidized bed'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0438398', 'cui_str': 'Flap failure'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0333525', 'cui_str': 'Maceration'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0179267', 'cui_str': 'Air-fluidized bed'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",38.0,0.0244111,"Complications, notably dehiscence and maceration, were significantly higher in the FIS group (40% vs 17%; P=0.0296).","[{'ForeName': 'Chitang J', 'Initials': 'CJ', 'LastName': 'Joshi', 'Affiliation': 'Division of Plastic & Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Carabano', 'Affiliation': 'Division of Plastic & Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Perez', 'Affiliation': 'Division of Plastic & Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ullrich', 'Affiliation': 'Division of Plastic & Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Abbas M', 'Initials': 'AM', 'LastName': 'Hassan', 'Affiliation': 'Division of Plastic & Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Rou', 'Initials': 'R', 'LastName': 'Wan', 'Affiliation': 'Division of Plastic & Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Plastic & Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Soriano', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Galiano', 'Affiliation': 'Division of Plastic & Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.13031']
1313,35642699,The adaptations in muscle architecture following whole body vibration training.,"OBJECTIVE


This study aims to investigate the effect of 8-week whole-body vibration (WBV) added to conventional training on muscular architecture, dynamic muscle strength and physical performance compared to controls in young basketball players.
METHODS


Sixteen young basketball players between the ages of 14-16 years were randomly assigned to whole body vibration group (VG) or control group (CG). Both groups were trained with a conventional program. Pennation angle (PeA), fascicle length and muscle thickness of Rectus Femoris (RF) and Vastus lateralis were measured by ultrasonography. Isokinetic dynamic muscle testing at 180 °/s and 60°/s, squat jump (SJ) and flexibility were evaluated before and after 8 weeks of training programs. Primary outcome measure was the fascicle length.
RESULTS


Fascicle length of RF, SJ height and flexibility increased significantly within VG compared to pretraining (p<0.05). SJ height increased in VG compared to CG significantly following training (p<0.05). PeA, fascicle length, muscle thicknesses, strength and flexibility did not differ between groups.
CONCLUSION


Eight weeks of WBV training improved fascicle length of RF, SJ height, and flexibility compared to pre-training. Addition of WBV to conventional training did not cause improvement in muscle architecture, strength and flexibility compared to conventional training alone.",2022,"Addition of WBV to conventional training did not cause improvement in muscle architecture, strength and flexibility compared to conventional training alone.","['Sixteen young basketball players between the ages of 14-16 years', 'young basketball players']","['Isokinetic dynamic muscle testing at 180 °/s and 60°/s, squat jump (SJ', '8-week whole-body vibration (WBV', 'conventional training', 'whole body vibration group (VG) or control group (CG', 'WBV training']","['muscular architecture, dynamic muscle strength and physical performance', 'Fascicle length of RF, SJ height and flexibility', 'SJ height', 'PeA, fascicle length, muscle thicknesses, strength and flexibility', 'Pennation angle (PeA), fascicle length and muscle thickness of Rectus Femoris (RF) and Vastus lateralis', 'muscle architecture, strength and flexibility', 'fascicle length of RF, SJ height, and flexibility', 'fascicle length']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",16.0,0.0121798,"Addition of WBV to conventional training did not cause improvement in muscle architecture, strength and flexibility compared to conventional training alone.","[{'ForeName': 'Eylem', 'Initials': 'E', 'LastName': 'Celik', 'Affiliation': 'Department of Coaching Education, Faculty of Sports Sciences, University of Pamukkale, Denizli, Turkey.'}, {'ForeName': 'Gulin', 'Initials': 'G', 'LastName': 'Findikoglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University of Pamukkale, Denizli, Turkey.'}, {'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Ozdemir Kart', 'Affiliation': 'Department of Physics, Faculty of Art and Science, University of Pamukkale, Denizli, Turkey.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Akkaya', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University of Pamukkale, Denizli, Turkey.'}, {'ForeName': 'Hayri', 'Initials': 'H', 'LastName': 'Ertan', 'Affiliation': 'Department of Coaching Education, Faculty of Sport Sciences, Eskisehir Technical University, Eskisehir, Turkey.'}]",Journal of musculoskeletal & neuronal interactions,[]
1314,35642697,Effects of a core stability exercise program on balance and coordination in children with cerebellar ataxic cerebral palsy.,"OBJECTIVE


To evaluate the effects of a core stability exercise program on balance, coordination, and severity of ataxia in children with cerebellar ataxic cerebral palsy (CP).
METHODS


Forty children with cerebellar ataxic CP (mean age: 6.75±1.35 years) were randomly assigned to a control group and an intervention group for 2 months of follow-up. The control group received a standard physical therapy program three times weekly (1 h  per session ), while the intervention group received a core stability program for 30 min, in addition to the selected physical therapy program. Both groups were evaluated pre-treatment and post-treatment using the Scale for the Assessment and Rating of Ataxia, the Balance Error Scoring Systems scale, Bruininks-Oseretsky tests of motor proficiency, and HUMAC balance system scores.
RESULTS


We found statistically significant reductions in the severity of ataxia, as well as improved balance and coordination in both groups, with stronger effects observed in the intervention group ( P <0.05).
CONCLUSION


The core stability program can improve balance and coordination in children with cerebellar ataxic CP when incorporated with a standard physical therapy program.",2022,"We found statistically significant reductions in the severity of ataxia, as well as improved balance and coordination in both groups, with stronger effects observed in the intervention group ( P <0.05).
","['Forty children with cerebellar ataxic CP (mean age: 6.75±1.35 years', 'children with cerebellar ataxic cerebral palsy', 'children with cerebellar ataxic CP', 'children with cerebellar ataxic cerebral palsy (CP']","['core stability exercise program', 'core stability program for 30 min, in addition to the selected physical therapy program', 'standard physical therapy program']","['severity of ataxia', 'balance, coordination, and severity of ataxia', 'Rating of Ataxia, the Balance Error Scoring Systems scale, Bruininks-Oseretsky tests of motor proficiency, and HUMAC balance system scores', 'balance and coordination']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0394005', 'cui_str': 'Ataxic cerebral palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0021608,"We found statistically significant reductions in the severity of ataxia, as well as improved balance and coordination in both groups, with stronger effects observed in the intervention group ( P <0.05).
","[{'ForeName': 'Mohamed Ali', 'Initials': 'MA', 'LastName': 'Elshafey', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Mohamed Samy', 'Initials': 'MS', 'LastName': 'Abdrabo', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Ragab Kamal', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Egypt.'}]",Journal of musculoskeletal & neuronal interactions,[]
1315,35643381,"A randomized, placebo-controlled, double-blind trial to evaluate efficacy and safety of Shen-Yuan-Dan capsules, a traditional Chinese medicine, for treatment of peri-procedure myocardial injury following percutaneous coronary intervention.","BACKGROUND


Peri-procedural myocardial injury (PMI) is a common complication of percutaneous coronary intervention (PCI), which cannot be entirely avoided using available treatments. The findings of earlier research have shown that Shen-Yuan-Dan (SYD) capsules, a traditional Chinese medicine, can potentially alleviating PMI. This study aimed to confirm further this hypothesis in a rigorous, well-designed randomized controlled study.
METHODS


Our clinical trial was randomized, double-blinded, and placebo-controlled. A total of 181 patients with unstable angina (UA) undergoing elective PCI were randomized to pretreatment with SYD or a placebo under the basis of conventional treatment; 87 patients were pretreated with SYD (4 capsules, 3 times a day, with a further 4 capsules 2 h before PCI) 3 days before the procedure, and 94 patients were given a placebo. No patients received reloading statins before PCI, and SYD or placebo was maintained for 1 month after PCI. The primary endpoint was the incidence of PMI. The secondary endpoint was calculating the incidence rate of all 30-day major adverse cardiovascular events (all-cause mortality, non-fatal myocardial infarction, unplanned revascularization). The safety outcomes, including abnormalities in electrocardiogram and serum biochemical examinations caused by drug use, were also tested.
RESULTS


The levels of creatine kinase-myocardial band (CK-MB) in both the SYD and placebo groups were increased at 4 h and 24 h after PCI compared with before the procedure (P < 0.05). The incidence rate of PMI in the SYD group (10.3 %) was lower than that in the placebo group (34 %) (absolute difference, 23.7 % [95 % CI, 11.7-34.8 %], P < 0.01). After taking SYD, the relative risk reduction (RRR) and absolute risk reduction (ARR) were 69.7 % and 24.3 %, respectively; further, number needed to treat (NNT) was 4.2. The 30-day major adverse cardiovascular event (MACE) rate was not statistically different between the SYD and placebo groups (6.9 % vs. 9.6 %, P = 0.352). There were no abnormal situations during the trial.
CONCLUSION


These findings showed that pretreatment with SYD could safely reduce the incidence rate of PMI in patients with UA undergoing elective PCI. Further study on the effects of SYD and how it can improve adverse cardiovascular events outcomes is needed.",2022,"The 30-day major adverse cardiovascular event (MACE) rate was not statistically different between the SYD and placebo groups (6.9% vs. 9.6%, P=0.352).","['181 patients with unstable angina (UA) undergoing elective PCI', 'patients with UA undergoing elective PCI']","['SYD', 'reloading statins before PCI, and SYD or placebo', 'percutaneous coronary intervention (PCI', 'Percutaneous Coronary Intervention', 'Shen-Yuan-Dan Capsules, A Traditional Chinese Medicine', 'placebo', 'Placebo']","['incidence rate of PMI', 'levels of creatine kinase-myocardial band (CK-MB', 'abnormalities in electrocardiogram and serum biochemical examinations', 'incidence of PMI', '30-day major adverse cardiovascular event (MACE) rate', 'relative risk reduction (RRR) and absolute risk reduction (ARR', 'incidence rate of all 30-day major adverse cardiovascular events (all-cause mortality, non-fatal myocardial infarction, unplanned revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",181.0,0.480174,"The 30-day major adverse cardiovascular event (MACE) rate was not statistically different between the SYD and placebo groups (6.9% vs. 9.6%, P=0.352).","[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hong-Xu', 'Initials': 'HX', 'LastName': 'Liu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China. Electronic address: liuhongxu@bjzhongyi.com.'}, {'ForeName': 'Ju-Ju', 'Initials': 'JJ', 'LastName': 'Shang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ai-Yong', 'Initials': 'AY', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao-Lei', 'Initials': 'XL', 'LastName': 'Lai', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wen-Long', 'Initials': 'WL', 'LastName': 'Xing', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Si-Han', 'Initials': 'SH', 'LastName': 'Jia', 'Affiliation': 'Beijing University of Traditional Chinese Medicine, Beijing, China.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2022.102841']
1316,35644071,A double-blind randomised crossover trial of low-dose flumazenil for benzodiazepine withdrawal: A proof of concept.,"INTRODUCTION


Benzodiazepines (BZD) are a class of anxiolytics with varying uses, which primarily act on the GABA A  receptor resulting in hyperpolarisation. BZDs are often a difficult drug class to cease once neuroadaptation has occurred; recommendations usually involve gradual dose reductions at variable rates. A growing body of evidence has suggested that low-dose flumazenil, a GABA A  receptor antagonist, may be a useful agent to allow for rapid detoxification.
AIM


To collect pilot data on the safety and efficacy of low-dose subcutaneous flumazenil to reduce BZD use, withdrawal symptoms, and craving in participants taking above and below the therapeutic maximum diazepam equivalent of 30 mg to inform on sample size for future trials.
METHOD


In a randomised double-blinded crossover study design, participants received low-dose flumazenil first (4 mg/24 h for approximately eight days) or placebo first. Groups were divided into those taking < 30 mg diazepam equivalent and ≥ 30 mg diazepam equivalent at baseline. Main outcome measures were percentage reduction in daily diazepam use, withdrawal symptoms, and craving scores from baseline, difference in diazepam use across the placebo first group, and flumazenil related adverse events.
RESULTS


Twenty-eight participants were recruited and randomised to flumazenil first (n = 14) and placebo first (n = 14). In participants taking ≥ 30 mg diazepam equivalent at baseline (n = 15), flumazenil significantly reduced diazepam use by 30.5% (p = 0.024) compared to placebo.
CONCLUSION


Low-dose flumazenil may aid in BZD detoxification in participants taking daily diazepam equivalent doses greater than or equal to the therapeutic maximum (≥30 mg) by reducing the need for diazepam.",2022,"In participants taking ≥ 30 mg diazepam equivalent at baseline (n = 15), flumazenil significantly reduced diazepam use by 30.5% (p = 0.024) compared to placebo.
","['participants taking above and below the therapeutic maximum diazepam equivalent of 30\xa0mg to inform on sample size for future trials', 'Twenty-eight participants']","['low-dose subcutaneous flumazenil', 'benzodiazepine', 'diazepam', 'flumazenil', 'diazepam equivalent and ≥', 'Benzodiazepines (BZD', 'placebo', 'flumazenil first']","['percentage reduction in daily diazepam use, withdrawal symptoms, and craving scores', 'safety and efficacy', 'BZD use, withdrawal symptoms, and craving']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]",28.0,0.541365,"In participants taking ≥ 30 mg diazepam equivalent at baseline (n = 15), flumazenil significantly reduced diazepam use by 30.5% (p = 0.024) compared to placebo.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'MacDonald', 'Affiliation': 'Currumbin Clinic, Currumbin, Queensland, Australia; School of Medicine, Griffith University, Australia. Electronic address: tmacdonald365@gmail.com.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Gallo', 'Affiliation': 'Division of Psychiatry, Medical School, The University of Western Australia, Australia; Fresh Start Recovery Programme, Subiaco, Western Australia, Australia. Electronic address: alexander.gallo@research.uwa.edu.au.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Basso-Hulse', 'Affiliation': 'Division of Psychiatry, Medical School, The University of Western Australia, Australia; Fresh Start Recovery Programme, Subiaco, Western Australia, Australia.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Bennett', 'Affiliation': 'Division of Psychiatry, Medical School, The University of Western Australia, Australia.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Hulse', 'Affiliation': 'Division of Psychiatry, Medical School, The University of Western Australia, Australia; School of Medical and Health Sciences, Edith Cowan University, Australia; Fresh Start Recovery Programme, Subiaco, Western Australia, Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109501']
1317,35649167,Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI).,"Objective:  Altered glutamatergic neurotransmission has been implicated in the pathogenesis of depression. This trial evaluated the efficacy and safety of AXS-05 (dextromethorphan-bupropion), an oral  N -methyl- D -aspartate (NMDA) receptor antagonist and σ 1  receptor agonist, in the treatment of major depressive disorder (MDD).
Methods:  This double-blind, phase 3 trial, was conducted between June 2019 and December 2019. Patients with a  DSM-5  diagnosis of MDD were randomized in a 1:1 ratio to receive dextromethorphan-bupropion (45 mg-105 mg tablet) or placebo, orally (once daily for days 1-3, twice daily thereafter) for 6 weeks. The primary endpoint was the change from baseline to week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Other efficacy endpoints and variables included MADRS changes from baseline at week 1 and 2, clinical remission (MADRS score ≤ 10), clinical response (≥ 50% reduction in MADRS score from baseline), clinician- and patient-rated global assessments, Quick Inventory of Depressive Symptomatology-Self-Rated, Sheehan Disability Scale, and quality of life measures.
Results:  A total of 327 patients were randomized: 163 patients to dextromethorphan-bupropion and 164 patients to placebo. Mean baseline MADRS total scores were 33.6 and 33.2 in the dextromethorphan-bupropion and placebo groups, respectively. The least-squares mean change from baseline to week 6 in MADRS total score was -15.9 points in the dextromethorphan-bupropion group and -12.0 points in the placebo group (least-squares mean difference, -3.87; 95% confidence interval [CI], -1.39 to -6.36;  P  = .002). Dextromethorphan-bupropion was superior to placebo for MADRS improvement at all time points including week 1 ( P  = .007) and week 2 ( P  < .001). Remission was achieved by 39.5% of patients with dextromethorphan-bupropion versus 17.3% with placebo (treatment difference, 22.2; 95% CI, 11.7 to 32.7;  P  < .001), and clinical response by 54.0% versus 34.0%, respectively (treatment difference, 20.0%; 95% CI, 8.4%, 31.6%;  P  < .001), at week 6. Results for most secondary endpoints were significantly better with dextromethorphan-bupropion than with placebo at almost all time points (eg, CGI-S least-squares mean difference at week 6, -0.48; 95% CI, -0.48 to -0.79;  P  = .002). The most common adverse events in the dextromethorphan-bupropion group were dizziness, nausea, headache, somnolence, and dry mouth. Dextromethorphan-bupropion was not associated with psychotomimetic effects, weight gain, or increased sexual dysfunction.
Conclusions:  In this phase 3 trial in patients with MDD, treatment with dextromethorphan-bupropion (AXS-05) resulted in significant improvements in depressive symptoms compared to placebo starting 1 week after treatment initiation and was generally well tolerated.
Trial Registration:  ClinicalTrials.gov Identifier: NCT04019704.",2022,Dextromethorphan-bupropion was superior to placebo for MADRS improvement at all time points including week 1 ( P  = .007) and week 2 ( P  < .001).,"['and 164 patients to', 'major depressive disorder (MDD', 'June 2019 and December 2019', 'Patients with a  DSM-5  diagnosis of MDD', '327 patients were randomized: 163 patients to', 'patients with MDD', 'Patients With Major Depressive Disorder']","['AXS-05', 'dextromethorphan-bupropion', 'Dextromethorphan-Bupropion', 'Dextromethorphan-bupropion', 'oral  N -methyl- D -aspartate (NMDA) receptor antagonist', 'AXS-05 (dextromethorphan-bupropion', 'placebo', 'dextromethorphan-bupropion (AXS-05']","['dizziness, nausea, headache, somnolence, and dry mouth', 'psychotomimetic effects, weight gain, or increased sexual dysfunction', 'depressive symptoms', 'tolerated', 'change from baseline to week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score', 'MADRS total score', 'Mean baseline MADRS total scores', 'Efficacy and Safety', 'clinical response', 'clinical remission (MADRS score ≤\u200910), clinical response (≥\u200950% reduction in MADRS score from baseline), clinician- and patient-rated global assessments, Quick Inventory of Depressive Symptomatology-Self-Rated, Sheehan Disability Scale, and quality of life measures', 'Remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",327.0,0.556976,Dextromethorphan-bupropion was superior to placebo for MADRS improvement at all time points including week 1 ( P  = .007) and week 2 ( P  < .001).,"[{'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Nathan Kline Institute and New York University School of Medicine, New York, New York.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Axsome Therapeutics, Inc, New York, New York.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': ""O'Gorman"", 'Affiliation': 'Axsome Therapeutics, Inc, New York, New York.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Streicher', 'Affiliation': 'Axsome Therapeutics, Inc, New York, New York.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Feliz', 'Affiliation': 'Axsome Therapeutics, Inc, New York, New York.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute, Boston, Massachusetts.'}, {'ForeName': 'Herriot', 'Initials': 'H', 'LastName': 'Tabuteau', 'Affiliation': 'Axsome Therapeutics, Inc, New York, New York.'}]",The Journal of clinical psychiatry,['10.4088/JCP.21m14345']
1318,35649128,Implications of providing wrist-hand orthoses for children with cerebral palsy: evidence from a randomised controlled trial.,"PURPOSE


To investigate the effects of providing rigid wrist-hand orthoses plus usual multidisciplinary care, on reducing hand impairments in children with cerebral palsy.
METHODS


A pragmatic, multicentre, assessor-blinded randomised controlled trial aimed to enrol 194 children aged 5-15 years, with wrist flexor Modified Ashworth Scale score ≥1. Randomisation with concealed allocation was stratified by study site and passive wrist range. The treatment group received a rigid wrist-hand orthosis, to wear ≥6 h per night for 3 years. Analysis included repeated measures mixed-effects linear regression models, using intention-to-treat principles.
RESULTS


The trial stopped early due to insufficient recruitment: 74 children, across all Manual Ability Classification System levels, were randomised ( n  = 38 orthosis group;  n  = 36 control). Mean age was 10.2 (SD 3.1) years (orthosis group) and 9.1 (SD 2.8) years (control). Data showed some evidence that rigid wrist-hand orthosis impacted passive wrist extension with fingers extended in the first year [mean difference between-groups at 6 months: 13.15° (95%CI: 0.81-25.48°,  p  = 0.04); 12 months: 20.94° (95%CI: 8.20-33.69°,  p  = 0.001)]. Beyond 18 months, participant numbers were insufficient for conclusive findings.
CONCLUSION


The study provided detailed data about short- and long-term effects of the wrist-hand orthosis and highlighted challenges in conducting large randomised controlled trials with this population.  Trial Registration:  Australia and New Zealand Clinical Trials Registry: U1111-1164-0572 IMPLICATIONS FOR REHABILITATIONThere may be incremental benefit, for children with cerebral palsy, at 6 and 12 months on passive wrist range from wearing a rigid wrist-hand orthosis designed according to this protocol.The rigid-wrist-hand orthosis evaluated in this study, which allowed for some tailoring for individual children's presentations, differed in design from past recommendations for ""resting hand"" positioning.Longitudinal follow up of children with cerebral palsy prescribed a rigid wrist-hand orthosis is essential to monitor any benefit.Minor adverse events were commonly experienced when wearing the orthosis and should be discussed prior to prescription of a rigid wrist-hand orthosis.",2022,Minor adverse events were commonly experienced when wearing the orthosis and should be discussed prior to prescription of a rigid wrist-hand orthosis.,"['U1111-1164-0572', 'Mean age was 10.2 (SD 3.1) years (orthosis group) and 9.1 (SD 2.8) years (control', 'children with cerebral palsy', '194 children aged 5-15\u2009years, with wrist flexor Modified Ashworth Scale score ≥1']","['wrist-hand orthoses', 'rigid wrist-hand orthoses plus usual multidisciplinary care', 'rigid wrist-hand orthosis, to wear ≥6\u2009h per night for 3\u2009years']",['passive wrist extension'],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C3877210', 'cui_str': 'Hand orthosis'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",194.0,0.229573,Minor adverse events were commonly experienced when wearing the orthosis and should be discussed prior to prescription of a rigid wrist-hand orthosis.,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Imms', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, and Murdoch Children's Research Institute, Parkville, Australia.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Wallen', 'Affiliation': 'School of Allied Health, Faculty of Health Sciences, Australian Catholic University, North Sydney, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Elliott', 'Affiliation': 'Telethon Kids Institute, Nedlands, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hoare', 'Affiliation': 'School of Occupational Therapy, La Trobe University, Bundoora, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Greaves', 'Affiliation': ""Murdoch Children's Research Institute, and The Royal Children's Hospital, Parkville, Australia.""}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Randall', 'Affiliation': ""Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Australia.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne Children's Trials Centre, Parkville, Australia.""}]",Disability and rehabilitation,['10.1080/09638288.2022.2079734']
1319,35652362,Does machine-vision-assisted dynamic navigation improve the accuracy of digitally planned prosthetically guided immediate implant placement? A randomized controlled trial.,"OBJECTIVES


This randomized controlled clinical trial was designed to compare the accuracy of machine-vision (MV)-based dynamic navigation (DN)-assisted immediate implant placement with the conventional freehand technique.
MATERIAL AND METHODS


A total of 24 subjects requiring immediate implant placement in maxillary anterior teeth were randomly assigned to either the control (freehand by an experienced surgeon, n = 12) or the test group (MV-DN, n = 12). Implant platform, implant apex, angular, and depth deviations with respect to prosthetically guided digital planning and differences in implant insertion torque (ITV) and implant stability quotient (ISQ) were compared between the groups.
RESULTS


MV-DN resulted in more accurate immediate implant position: significantly smaller global platform deviation (1.01 ± 0.41 mm vs. 1.51 ± 0.67 mm, p = .038), platform depth deviation (0.44 ± 0.46 mm vs. 0.95 ± 0.68 mm, p = .045), global apex deviation (0.88 ± 0.43 mm vs. 1.94 ± 0.86 mm, p = .001), and lateral apex deviation (0.68 ± 0.30 mm vs. 1.61 ± 0.88 mm, p = .004) were found in MV-DN compared to controls. No significant intergroup differences were observed for ITV and ISQ.
CONCLUSIONS


MV-DN achieved more precise immediate implant position and comparable primary stability. Further trials are necessary to assess the benefits in terms of esthetics and tissue health/stability.",2022,"RESULTS


MV-DN resulted in more accurate immediate implant position: significantly smaller global platform deviation (1.01±0.41 mm vs. 1.51±0.67 mm, P=0.038), platform depth deviation (0.44±0.46 mm vs. 0.95±0.68 mm, P=0.045), global apex deviation (0.88±0.43 mm vs. 1.94±0.86 mm, P=0.001), and lateral apex deviation (0.68±0.30 mm vs. 1.61±0.88 mm, P=0.004) were found in MV-DN compared to controls.",['24 subjects requiring immediate implant placement in maxillary anterior teeth'],"['Machine-Vision Assisted Dynamic Navigation', 'machine-vision (MV) based dynamic navigation (DN) assisted immediate implant placement']","['lateral apex deviation', 'global apex deviation', 'global platform deviation', 'implant insertion torque (ITV) and implant stability quotient (ISQ', 'ITV and ISQ', 'platform depth deviation']","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",24.0,0.117969,"RESULTS


MV-DN resulted in more accurate immediate implant position: significantly smaller global platform deviation (1.01±0.41 mm vs. 1.51±0.67 mm, P=0.038), platform depth deviation (0.44±0.46 mm vs. 0.95±0.68 mm, P=0.045), global apex deviation (0.88±0.43 mm vs. 1.94±0.86 mm, P=0.001), and lateral apex deviation (0.68±0.30 mm vs. 1.61±0.88 mm, P=0.004) were found in MV-DN compared to controls.","[{'ForeName': 'Shi-Min', 'Initials': 'SM', 'LastName': 'Wei', 'Affiliation': ""Shanghai PerioImplant Innovation Center and Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Shanghai PerioImplant Innovation Center and Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Deng', 'Affiliation': ""Shanghai PerioImplant Innovation Center and Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Hong-Chang', 'Initials': 'HC', 'LastName': 'Lai', 'Affiliation': ""Shanghai PerioImplant Innovation Center and Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Maurizio S', 'Initials': 'MS', 'LastName': 'Tonetti', 'Affiliation': ""Shanghai PerioImplant Innovation Center and Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Jun-Yu', 'Initials': 'JY', 'LastName': 'Shi', 'Affiliation': ""Shanghai PerioImplant Innovation Center and Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}]",Clinical oral implants research,['10.1111/clr.13961']
1320,35656979,Predictors of Recurrent Stroke After Embolic Stroke of Undetermined Source in the RE-SPECT ESUS Trial.,"Background We sought to determine recurrent stroke predictors among patients with embolic strokes of undetermined source (ESUS). Methods and Results We applied Cox proportional hazards models to identify clinical features associated with recurrent stroke among participants enrolled in RE-SPECT ESUS (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) trial, an international clinical trial evaluating dabigatran versus aspirin for patients with ESUS. During a median follow-up of 19 months, 384 of 5390 participants had recurrent stroke (annual rate, 4.5%). Multivariable models revealed that stroke or transient ischemic attack before the index event (hazard ratio [HR], 2.27 [95% CI, 1.83-2.82]), creatinine clearance <50 mL/min (HR, 1.69 [95% CI, 1.23-2.32]), male sex (HR, 1.60 [95% CI, 1.27-2.02]), and CHA 2 DS 2 -VASc ≥4 (HR, 1.55 [95% CI, 1.15-2.08] and HR, 1.66 [95% CI, 1.21-2.26] for scores of 4 and ≥5, respectively) versus CHA 2 DS 2 -VASc of 2 to 3, were independent predictors for recurrent stroke. Conclusions In RE-SPECT ESUS trial, expected risk factors previously linked to other common stroke causes were associated with stroke recurrence. These data help define high-risk groups for subsequent stroke that may be useful for clinicians and for researchers designing trials among patients with ESUS. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02239120.",2022,"Multivariable models revealed that stroke or transient ischemic attack before the index event (hazard ratio [HR], 2.27 [95% CI, 1.83-2.82]), creatinine clearance <50 mL/min (HR, 1.69 [95% CI, 1.23-2.32]), male sex (HR, 1.60 [95% CI, 1.27-2.02]), and CHA 2 DS 2 -VASc ≥4 (HR, 1.55 [95% CI, 1.15-2.08] and HR, 1.66","['patients with embolic strokes of undetermined source (ESUS', 'patients with ESUS', 'participants enrolled in RE-SPECT ESUS (Randomized, Double-Blind', 'Patients With Embolic Stroke of Undetermined Source']","['dabigatran versus aspirin', 'Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid']","['Recurrent Stroke', 'creatinine clearance', 'stroke or transient ischemic attack', 'recurrent stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}]","[{'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]",5390.0,0.423521,"Multivariable models revealed that stroke or transient ischemic attack before the index event (hazard ratio [HR], 2.27 [95% CI, 1.83-2.82]), creatinine clearance <50 mL/min (HR, 1.69 [95% CI, 1.23-2.32]), male sex (HR, 1.60 [95% CI, 1.27-2.02]), and CHA 2 DS 2 -VASc ≥4 (HR, 1.55 [95% CI, 1.15-2.08] and HR, 1.66","[{'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Del Brutto', 'Affiliation': 'Department of Neurology University of Miami Miller School of Medicine Miami FL.'}, {'ForeName': 'Han-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Department of Neurology University Duisburg-Essen Essen Germany.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology University of California San Francisco CA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute Durham NC.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cronin', 'Affiliation': 'Boehringer Ingelheim Pharma Burlington Ontario Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG Biberach Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Grauer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG Biberach Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH Ingelheim Germany.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine National Cerebral and Cardiovascular Center Suita Osaka Japan.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Schellinger', 'Affiliation': 'Johannes Wesling Medical Center, MindenUK RUB Minden Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lyrer', 'Affiliation': 'University Hospital Basel Basel Switzerland.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Vall d'Hebron Stroke Center Barcelona Spain.""}, {'ForeName': 'Aurauma', 'Initials': 'A', 'LastName': 'Chutinet', 'Affiliation': 'Department of Medicine Faculty of Medicine Chulalongkorn UniversityChulalongkorn Stroke CenterKing Chulalongkorn Memorial HospitalThai Red Cross Society Bangkok Thailand.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Bladin', 'Affiliation': 'Eastern Health Clinical School Monash University Melbourne Australia.'}, {'ForeName': 'Conrado J', 'Initials': 'CJ', 'LastName': 'Estol', 'Affiliation': 'Stroke UnitSanatorio Guemes and Breyna Buenos Aires Argentina.'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Department of Neurology University of Miami Miller School of Medicine Miami FL.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.023545']
1321,35660539,"Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension.","RATIONALE AND OBJECTIVE


APOL1 risk alleles are associated with increased cardiovascular and chronic kidney disease (CKD) risk. It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease.
STUDY DESIGN


Multicenter, pragmatic, randomized controlled clinical trial.
SETTING AND PARTICIPANTS


6650 individuals with African ancestry and hypertension from 13 health systems.
INTERVENTION


APOL1 genotyping with clinical decision support (CDS) results are returned to participants and providers immediately (intervention) or at 6 months (control). A subset of participants are re-randomized to pharmacogenomic testing for relevant antihypertensive medications (pharmacogenomic sub-study). CDS alerts encourage appropriate CKD screening and antihypertensive agent use.
OUTCOMES


Blood pressure and surveys are assessed at baseline, 3 and 6 months. The primary outcome is change in systolic BP from enrollment to 3 months in individuals with two APOL1 risk alleles. Secondary outcomes include new diagnoses of CKD, systolic blood pressure at 6 months, diastolic BP, and survey results. The pharmacogenomic sub-study will evaluate the relationship of pharmacogenomic genotype and change in systolic BP between baseline and 3 months.
RESULTS


To date, the trial has enrolled 3423 participants.
CONCLUSIONS


The effect of patient and provider knowledge of APOL1 genotype on systolic blood pressure has not been well-studied. GUARDD-US addresses whether blood pressure improves when patients and providers have this information. GUARDD-US provides a CDS framework for primary care and specialty clinics to incorporate APOL1 genetic risk and pharmacogenomic prescribing in the electronic health record.
TRIAL REGISTRATION


ClinicalTrials.govNCT04191824.",2022,"It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease.
","['patients with hypertension', '6650 individuals with African ancestry and hypertension from 13 health systems', 'enrolled 3423 participants']",[],"['change in systolic BP', 'new diagnoses of CKD, systolic blood pressure at 6\u202fmonths, diastolic BP, and survey results', 'systolic BP', 'blood pressure', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",3423.0,0.39387,"It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease.
","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Eadon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Cavanaugh', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Orlando', 'Affiliation': 'Duke University School of Medicine, Durham, NC 27720, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Christian', 'Affiliation': 'Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Duke University School of Medicine, Durham, NC 27720, USA; Duke Clinical Research Institute, Durham, NC 27720, USA.'}, {'ForeName': 'Kady-Ann', 'Initials': 'KA', 'LastName': 'Steen-Burrell', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC 27720, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC 27720, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hauser', 'Affiliation': 'Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Institute for Family Health, New York, NY 10029, USA.'}, {'ForeName': 'Rajbir', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Meharry Medical College, Nashville, TN 37208, USA.'}, {'ForeName': 'Cherry Maynor', 'Initials': 'CM', 'LastName': 'Beasley', 'Affiliation': 'McKenzie-Elliott School of Nursing, University of North Carolina at Pembroke, Pembroke, NC 28372, USA.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Fuloria', 'Affiliation': 'Office of Research, University Medical Center New Orleans, New Orleans, LA 70112, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'Baylor Scott & White Health, Baylor University, Robbins Institute for Health Policy & Leadership, Dallas, TX 75246, USA.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Parker', 'Affiliation': 'University of Florida College of Medicine - Jacksonville, Jacksonville, FL 32209, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Henry H', 'Initials': 'HH', 'LastName': 'Ong', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Elwood', 'Affiliation': 'University of Florida, College of Pharmacy, Gainesville, FL 32610, USA.'}, {'ForeName': 'Sheryl E', 'Initials': 'SE', 'LastName': 'Lynch', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Clermont', 'Affiliation': 'Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Cicali', 'Affiliation': 'University of Florida, College of Pharmacy, Gainesville, FL 32610, USA.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Starostik', 'Affiliation': 'University of Florida, College of Medicine, Gainesville, FL 32610, USA.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Pratt', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Khoa A', 'Initials': 'KA', 'LastName': 'Nguyen', 'Affiliation': 'University of Florida, College of Pharmacy, Gainesville, FL 32610, USA.'}, {'ForeName': 'Marc B', 'Initials': 'MB', 'LastName': 'Rosenman', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Calman', 'Affiliation': 'Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Institute for Family Health, New York, NY 10029, USA.'}, {'ForeName': 'Mimsie', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Bethel Gospel Assembly, New York, NY 10035, USA.'}, {'ForeName': 'Girish N', 'Initials': 'GN', 'LastName': 'Nadkarni', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Ebony B', 'Initials': 'EB', 'LastName': 'Madden', 'Affiliation': 'Division of Genomic Medicine, National Human Genome Research Institute, Bethesda, MD 20892, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Kucher', 'Affiliation': 'Division of Genomic Medicine, National Human Genome Research Institute, Bethesda, MD 20892, USA.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Volpi', 'Affiliation': 'Division of Genomic Medicine, National Human Genome Research Institute, Bethesda, MD 20892, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Dexter', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Skaar', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'University of Florida, College of Pharmacy, Gainesville, FL 32610, USA.'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Cooper-DeHoff', 'Affiliation': 'University of Florida, College of Pharmacy, Gainesville, FL 32610, USA. Electronic address: dehoff@cop.ufl.edu.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Horowitz', 'Affiliation': 'Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Electronic address: carol.horowitz@mountsinai.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2022.106813']
1322,35660514,Self- and Situation-Focused Reappraisal are not homogeneous: Evidence from behavioral and brain networks.,"Reappraisal is an effective emotion regulation strategy which can be divided into self- and situation-focused subtypes. Previous studies have produced inconsistent findings on the moderating effects and neural mechanisms of reappraisal; thus, further research is necessary to clarify these inconsistencies. In this study, a total of 44 participants were recruited and randomly assigned to two groups. 23 participants were assigned to the self-focused group, while 21 participants were assigned to the situation-focused group. The participants' resting EEG data were collected for 6 min before the experiment began, followed by an emotional regulation task. During this task, participants were asked to view emotion-provoking images under four emotion regulation conditions (View, Watch, Increase, or Decrease). Late positive potential (LPP) was obtained when these emotional images were observed. LPP is an effective physiological indicator of emotion regulation, enabling this study to explore emotion regulation under different reappraisal strategies, as well as the functional connectivity and node efficiency within the brain. It was found that, in terms of the effect on emotion regulation, situation-focused reappraisal was significantly better than self-focused reappraisal at enhancing the valence of negative emotion, while self-focused reappraisal was significantly better than situation-focused reappraisal at increasing the arousal of negative emotion. In terms of neural mechanisms, multiple brain regions such as the anterior cingulate cortex, the frontal lobe, the parahippocampal gyrus, parts of the temporal lobe, and parts of the parietal lobe were involved in both reappraisal processes. In addition, there were some differences in brain regions associated with different forms of cognitive reappraisal. Self-focused reappraisal was associated with the posterior cingulate gyrus, fusiform gyrus, and lingual gyrus, and situation-focused reappraisal was associated with the parietal lobule, anterior central gyrus, and angular gyrus. In conclusion, this research demonstrates that self- and situation-focused reappraisal are not homogenous in terms of their effects and neural mechanisms and clarifies the uncertainties over their regulatory effects. Different types of reappraisal activate different brain regions when used, and the functional connectivity or node efficiency of these brain regions seems to be a suitable indicator for assessing the effects of different types of reappraisal.",2022,"Self-focused reappraisal was associated with the posterior cingulate gyrus, fusiform gyrus, and lingual gyrus, and situation-focused reappraisal was associated with the parietal lobule, anterior central gyrus, and angular gyrus.","['23 participants', '44 participants']",['LPP'],"['Late positive potential (LPP', 'emotion regulation, situation-focused reappraisal']",[],[],"[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",44.0,0.025485,"Self-focused reappraisal was associated with the posterior cingulate gyrus, fusiform gyrus, and lingual gyrus, and situation-focused reappraisal was associated with the parietal lobule, anterior central gyrus, and angular gyrus.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'School of Psychology, Liaoning Normal University, Dalian, 116029, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'School of Psychology, Liaoning Normal University, Dalian, 116029, China.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'School of Psychology, Liaoning Normal University, Dalian, 116029, China; Department of Psychology, Shanxi Datong University, Datong, 037009, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Psychology, Liaoning Normal University, Dalian, 116029, China. Electronic address: yliu@lnnu.edu.cn.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2022.108282']
1323,35638295,"Pilot phase results of a prospective, randomized controlled trial of narrowband ultraviolet B phototherapy in hospitalized COVID-19 patients.","COVID-19 morbidity and mortality are driven by poor immune regulation. Narrowband ultraviolet B (NB-UVB) phototherapy is standard of care in a number of immune-dysregulated diseases. To assess the efficacy of NB-UVB phototherapy for improving COVID-19 outcomes in high-risk, hospitalized, we developed the Adaptive Photo-Protection Trial. This is a multi-center, prospective, double-blinded, randomized, placebo-controlled trial. The pilot phase results are reported here. Consecutive patients admitted with a positive COVID-19 PCR were screened for eligibility. Enrolled subjects were computer randomized 1:1 to NB-UVB or placebo phototherapy. Subjects were treated daily with escalating doses on 27% of their body surface area for up to 8 consecutive days. Primary outcomes were safety and efficacy, defined as persistent or painful erythema and 28-day mortality. Comparisons were made via non-parametric exact tests. Patients in treatment (n = 15) and placebo (n = 15) arms had similar demographics. No adverse events occurred. Twenty eight-day mortality was 13.3% in treatment vs. 33.3% in placebo arms (p = 0.39). NB-UVB phototherapy in hospitalized COVID-19 patients was safe. Decreased mortality was observed in treated patients but this was statistically non-significant. Given its low-cost, scalability, and adjunctive nature, NB-UVB has the potential to improve COVID-19 outcomes. Continuation of this trial is warranted.",2022,"28-day mortality was 13.3% in treatment vs. 33.3% in placebo arms (p=0.39).
","['Hospitalized COVID-19 Patients', 'Consecutive patients admitted with a positive COVID-19 PCR were screened for eligibility']","['phototherapy', 'Narrowband Ultraviolet B Phototherapy', 'NB-UVB or placebo phototherapy', 'NB-UVB phototherapy', 'Narrowband ultraviolet B (NB-UVB', 'placebo']","['28-day mortality', 'safety and efficacy, defined as persistent or painful erythema and 28-day mortality', 'Decreased mortality']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C3472306', 'cui_str': 'Narrowband ultraviolet B phototherapy'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.234471,"28-day mortality was 13.3% in treatment vs. 33.3% in placebo arms (p=0.39).
","[{'ForeName': 'Frank H', 'Initials': 'FH', 'LastName': 'Lau', 'Affiliation': 'Department of Surgery, Louisiana State University Health Sciences Center New Orleans, New Orleans, Louisiana, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Powell', 'Affiliation': 'Department of Surgery, Louisiana State University Health Sciences Center New Orleans, New Orleans, Louisiana, USA.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Adonecchi', 'Affiliation': 'School of Medicine, Louisiana State University Health Sciences Center New Orleans, New Orleans, Louisiana, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Danos', 'Affiliation': 'School of Public Health, Louisiana State University Health Sciences Center New Orleans, New Orleans, Louisiana, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'DiNardo', 'Affiliation': 'Baylor College of Medicine, Global TB program and William T Shearer Center for Human Immunobiology, Houston, Texas, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Chugden', 'Affiliation': 'West Jefferson Medical Center, Marrero, Louisiana, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wolf', 'Affiliation': 'Department of Dermatology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Carmen F', 'Initials': 'CF', 'LastName': 'Castilla', 'Affiliation': 'New York Dermatology Group; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}]",Experimental dermatology,['10.1111/exd.14617']
1324,35641979,"Effects of a smartphone application named ""Shared Decision Making Assistant"" for informed patients with primary liver cancer in decision-making in China: a quasi-experimental study.","BACKGROUND


It is well known that decision aids can promote patients' participation in decision-making, increase patients' decision preparation and reduce decision conflict. The goal of this study is to explore the effects of a ""Shared Decision Making Assistant"" smartphone application on the decision-making of informed patients with Primary Liver Cancer (PLC) in China.
METHODS


In this quasi-experimental study , 180 PLC patients who knew their real diagnoses in the Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China, from April to December 2020 were randomly assigned to a control group and an intervention group. Patients in the intervention group had an access to the ""Shared Decision Making Assistant"" application in decision-making, which included primary liver cancer treatment knowledge, decision aids path, continuing nursing care video clips, latest information browsing and interactive platforms. The study used decision conflict scores to evaluate the primary outcome, and the data of decision preparation, decision self-efficacy, decision satisfaction and regret, and knowledge of PLC treatment for secondary outcomes. Then, the data were entered into the SPSS 22.0 software and were analyzed by descriptive statistics, Chi-square, independent t-test, paired t-test, and Mann-Whitney tests.
RESULTS


Informed PLC patients in the intervention group (""SDM Assistant"" group) had significantly lower decision conflict scores than those in the control group. (""SDM Assistant"" group: 16.89 ± 8.80 vs. control group: 26.75 ± 9.79, P < 0.05). Meanwhile, the decision preparation score (80.73 ± 8.16), decision self-efficacy score (87.75 ± 6.87), decision satisfaction score (25.68 ± 2.10) and knowledge of PLC treatment score (14.52 ± 1.91) of the intervention group were significantly higher than those of the control group patients (P < 0.05) at the end of the study. However, the scores of ""regret of decision making"" between the two groups had no statistical significance after 3 months (P > 0.05).
CONCLUSIONS


Access to the ""Shared Decision Making Assistant"" enhanced the PLC patients' performance and improved their quality of decision making in the areas of decision conflict, decision preparation, decision self-efficacy, knowledge of PLC treatment and satisfaction. Therefore, we recommend promoting and updating the ""Shared Decision Making Assistant"" in clinical employment and future studies.",2022,"CONCLUSIONS


Access to the ""Shared Decision Making Assistant"" enhanced the PLC patients' performance and improved their quality of decision making in the areas of decision conflict, decision preparation, decision self-efficacy, knowledge of PLC treatment and satisfaction.","['patients with Primary Liver Cancer (PLC) in China', '180 PLC patients who knew their real diagnoses in the Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China, from April to December 2020', 'patients with primary liver cancer in decision-making in China']","['Shared Decision Making Assistant"" smartphone application', 'smartphone application named ""Shared Decision Making Assistant']","['decision self-efficacy score', 'decision satisfaction score', 'knowledge of PLC treatment score', 'scores of ""regret of decision making', 'decision conflict scores', 'data of decision preparation, decision self-efficacy, decision satisfaction and regret, and knowledge of PLC treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024620', 'cui_str': 'Primary malignant neoplasm of liver'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]","[{'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0027365', 'cui_str': 'Name'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0024620', 'cui_str': 'Primary malignant neoplasm of liver'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",180.0,0.0383679,"CONCLUSIONS


Access to the ""Shared Decision Making Assistant"" enhanced the PLC patients' performance and improved their quality of decision making in the areas of decision conflict, decision preparation, decision self-efficacy, knowledge of PLC treatment and satisfaction.","[{'ForeName': 'Sitong', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Nursing, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, No. 700 Moyu Road, Jiading District, Shanghai, 201805, People's Republic of China.""}, {'ForeName': 'Qingwen', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ""Department of Nursing, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, No. 700 Moyu Road, Jiading District, Shanghai, 201805, People's Republic of China.""}, {'ForeName': 'Zhixia', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Department of Nursing, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, No. 700 Moyu Road, Jiading District, Shanghai, 201805, People's Republic of China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Nursing, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, No. 700 Moyu Road, Jiading District, Shanghai, 201805, People's Republic of China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': ""Department of No. 5 Hepatobiliary Surgery, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 201805, People's Republic of China.""}, {'ForeName': 'Zeya', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': ""Department of No. 3 Hepatobiliary Surgery, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 201805, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Organ Transplantation, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, 201805, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Nursing, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, No. 700 Moyu Road, Jiading District, Shanghai, 201805, People's Republic of China. smallsweetlily@163.com.""}]",BMC medical informatics and decision making,['10.1186/s12911-022-01883-w']
1325,35643018,"Effect of mobile health intervention for self-management on self-efficacy, motor and non-motor symptoms, self-management, and quality of life in people with Parkinson's disease: Randomized controlled trial.","OBJECTIVES


To evaluate the effects of a mobile health intervention for self-management on self-efficacy, motor and non-motor symptoms, self-management, and quality of life in people with Parkinson's disease.
METHODS


A randomized controlled design was used. The participants were randomly assigned to an intervention or a control group. The intervention group (n = 20) received mobile health intervention comprising mobile applications, smartwatches, smartphone-based short text messages and information, and telephone counselling; whereas the control group (n = 23) received short text messages and telephone counselling for 16 weeks.
RESULTS


After 16 weeks, self-efficacy and non-motor symptom scores in the intervention group significantly improved compared to those in the control group. However, no significant differences were observed in the motor symptoms, self-management, and quality of life between the groups.
CONCLUSIONS


The mobile health intervention for self-management is effective for self-efficacy and non-motor symptoms in people with Parkinson's disease.",2022,The mobile health intervention for self-management is effective for self-efficacy and non-motor symptoms in people with Parkinson's disease.,"[""people with Parkinson's disease""]","['mobile health intervention comprising mobile applications, smartwatches, smartphone-based short text messages and information, and telephone counselling', 'short text messages and telephone counselling for 16 weeks', 'mobile health intervention']","['self-efficacy, motor and non-motor symptoms, self-management, and quality of life', 'self-efficacy and non-motor symptom scores', 'motor symptoms, self-management, and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.019676,The mobile health intervention for self-management is effective for self-efficacy and non-motor symptoms in people with Parkinson's disease.,"[{'ForeName': 'Yusun', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Korea University Nursing Research Institute, Korea University, Anam-ro 145, Seongbuk-gu, Seoul 02841, Republic of Korea.'}, {'ForeName': 'Sung Reul', 'Initials': 'SR', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Korea University Nursing Research Institute, Korea University, Anam-ro 145, Seongbuk-gu, Seoul 02841, Republic of Korea. Electronic address: srkim74@korea.ac.kr.'}, {'ForeName': 'Hui Young', 'Initials': 'HY', 'LastName': 'So', 'Affiliation': 'Department of Nursing, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Sungyang', 'Initials': 'S', 'LastName': 'Jo', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Seoul Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Yun Su', 'Initials': 'YS', 'LastName': 'Hwang', 'Affiliation': 'Department of Neurology, Jeonbuk National University Medical School and Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Mi Sun', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Sun Ju', 'Initials': 'SJ', 'LastName': 'Chung', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.05.003']
1326,35643013,"Comment on ""Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial"".",,2022,,['major abdominal surgery'],['liposomal bupivacaine'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.141441,,"[{'ForeName': 'Fu-Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China. Electronic address: xuefushan@aliyun.com.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Tian', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Xin-Tao', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2022.110869']
1327,35642832,Efficacy and safety of fibrinogen administration in acute post-traumatic hypofibrinogenemia in isolated severe traumatic brain injury: A randomized clinical trial.,"AIM


This study was conducted to evaluate clinical outcomes after fibrinogen administration in hypofibrinogenemia following severe traumatic brain injury.
BACKGROUND


Post traumatic coagulopathy (PTC) is a common but devastating medical condition in patients with severe head injury. Hypofibrinogenemia is considered as an indicator for poor clinical outcomes in traumatic brain injury (TBI).
METHODS


In this randomized clinical trial (RCT), primarily 137 patients with severe traumatic brain injury (Glasgow coma scale score: GCS < 9) were enrolled. Thereafter, their plasma fibrinogen level was measured. The patients with primary hypofibrinogenemia (<200 mg/dL) with no concurrent coagulopathy were randomly allocated into fibrinogen-receiving (n = 50) and control (n = 54) groups. P-value < 0.05 was considered as statistically significant.
RESULTS


Seventy-one patients were analyzed in the final step of the study. The mean value for age in fibrinogen and control groups was 25.64 ± 10.71 and 28.91 ± 12.25 years old, respectively. Male - female patients in both groups were equally distributed. In the fibrinogen receiving group, GCS scores were significantly higher after 24, 48, and 72 h compared to the control group (p = 0.000). Hematoma expansion was better controlled in the fibrinogen receiving group (p = 0.000). Notably, the number needed to treat (NNT) for fibrinogen infusion and hematoma expansion control was 2.3. Glasgow outcome scale-extended (GOSE) was significantly better in the fibrinogen group (p = 0.25). Multiple regression tests showed intracerebral hematoma (ICH) and severe brain edema had the most detrimental effect on GOSE outcomes. The need for cranial surgery, hospital stay duration, mechanical ventilator dependency, in hospital and 90-day post discharge mortality rates were similar in both study groups.
CONCLUSION


In severe TBI, hypofibrinogenemia correction (>200 mg/dL) could improve GOSE, GCS score progression within 3 days after primary head injury and hematoma expansion controllability.",2022,Glasgow outcome scale-extended (GOSE) was significantly better in the fibrinogen group (p = 0.25).,"['patients with primary hypofibrinogenemia (<200\xa0mg/dL) with no concurrent coagulopathy', 'Seventy-one patients were analyzed in the final step of the study', '137 patients with severe traumatic brain injury (Glasgow coma scale score: GCS\xa0<\xa09) were enrolled', 'patients with severe head injury', 'Male - female patients in both groups were equally distributed', 'acute post-traumatic hypofibrinogenemia in isolated severe traumatic brain injury']","['fibrinogen administration in hypofibrinogenemia', 'fibrinogen administration', 'Hypofibrinogenemia', 'fibrinogen-receiving (n\xa0=\xa050) and control']","['plasma fibrinogen level', 'GOSE, GCS score progression', 'Glasgow outcome scale-extended (GOSE', 'intracerebral hematoma (ICH) and severe brain edema', 'Efficacy and safety', 'Hematoma expansion', 'need for cranial surgery, hospital stay duration, mechanical ventilator dependency, in hospital and 90-day post discharge mortality rates', 'GCS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0553681', 'cui_str': 'Hypofibrinogenemia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]","[{'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0553681', 'cui_str': 'Hypofibrinogenemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0021870', 'cui_str': 'Intracerebral hematoma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042497', 'cui_str': 'Mechanical ventilator'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",137.0,0.13842,Glasgow outcome scale-extended (GOSE) was significantly better in the fibrinogen group (p = 0.25).,"[{'ForeName': 'Masih', 'Initials': 'M', 'LastName': 'Sabouri', 'Affiliation': 'Department of Neurosurgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Vahidian', 'Affiliation': 'Department of Neurosurgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Sourani', 'Affiliation': 'Department of Neurosurgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: armansourani@yahoo.com.'}, {'ForeName': 'Sadegh Baradaran', 'Initials': 'SB', 'LastName': 'Mahdavi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Student Research Committee, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Donya Sheibani', 'Initials': 'DS', 'LastName': 'Tehrani', 'Affiliation': 'Department of IT, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shafiei', 'Affiliation': 'Non-Communicable Diseases Research Center, Ilam University of Medical Sciences, Iran.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2022.05.016']
1328,35644376,Clinic navigation and home visits to improve asthma care in low income adults with poorly controlled asthma: Before and during the pandemic.,"Asthma-related deaths, hospitalizations, and emergency visits are more numerous among low-income patients, yet management guidelines do not address this high-risk group's special needs. We recently demonstrated feasibility, acceptability, and preliminary evidence of effectiveness of two interventions to improve access to care, patient-provider communication, and asthma outcomes: 1) Clinic Intervention (CI): study staff facilitated patient preparations for office visits, attended visits, and afterwards confirmed patient understanding of physician recommendations, and 2) Home Visit (HV) by community health workers for care coordination and informing clinicians of home barriers to managing asthma. The current project, denominated ""HAP3,"" combines these interventions for greater effectiveness, delivery of guideline-based asthma care, and asthma control for low-income patients recruited from 6 primary care and 3 asthma specialty practices. We assess whether patients of clinicians receiving guideline-relevant, real-time feedback on patient health and home status have better asthma outcomes. In a pragmatic factorial longitudinal trial, HAP3 enrolls 400 adults with uncontrolled asthma living in low-income urban neighborhoods. 100 participants will be randomized to each of four interventions: (1) CI, (2) CI with HVs, (3) CI and real-time feedback to asthma clinician of guideline-relevant elements of patients' current care, or (4) both (2) and (3). The outcomes are asthma control, quality of life, ED visits, hospitalizations, prednisone bursts, and intervention costs. The COVID-19 pandemic struck 6.5 months into recruitment. We describe study development, design, methodology, planned analysis, baseline findings and adaptions to achieve the original aims of improving patient-clinician communication and asthma outcomes despite the markedly changed pandemic environment.",2022,"The outcomes are asthma control, quality of life, ED visits, hospitalizations, prednisone bursts, and intervention costs.","['low income adults with poorly controlled asthma', 'enrolls 400 adults with uncontrolled asthma living in low-income urban neighborhoods', '100 participants', 'low-income patients recruited from 6 primary care and 3 asthma specialty practices', 'study staff facilitated patient preparations for office visits, attended visits, and afterwards confirmed patient understanding of physician recommendations, and 2) Home Visit (HV) by community health workers for care coordination and informing clinicians of home barriers to managing asthma']","['HAP3', 'Clinic Intervention (CI', 'Clinic navigation and home visits']","['asthma control, quality of life, ED visits, hospitalizations, prednisone bursts, and intervention costs']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0582431', 'cui_str': 'Preparation of patient'}, {'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",400.0,0.0716107,"The outcomes are asthma control, quality of life, ED visits, hospitalizations, prednisone bursts, and intervention costs.","[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Apter', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, 829 Gates/ HUP, 3400 Spruce Street, Philadelphia, PA 19104, USA. Electronic address: Andrea.apter@pennmedicine.upenn.edu.'}, {'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, CHOP Roberts Building, 27616 South Street Room 9364, Philadelphia, PA 19146, USA. Electronic address: stephenst@email.chop.edu.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, 829 Gates/ HUP, 3400 Spruce Street, Philadelphia, PA 19104, USA; Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, 600 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104, USA. Electronic address: HanXiaoy@pennmedicine.upenn.edu.'}, {'ForeName': 'Hami', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, 829 Gates/ HUP, 3400 Spruce Street, Philadelphia, PA 19104, USA. Electronic address: hami.park@pennmedicine.upenn.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania, 6th floor, 3701 Market Street, Philadelphia, PA 19104, USA. Electronic address: Anna.Morgan@pennmedicine.upenn.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Klusaritz', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Room 143 Anatomy Chemistry, 3620 Hamilton Walk, Philadelphia, PA 19104, USA. Electronic address: Heather.Klusaritz@pennmedicine.upenn.edu.'}, {'ForeName': 'Zuleyha', 'Initials': 'Z', 'LastName': 'Cidav', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania 3535 Market Street, Philadelphia, PA 19104, USA. Electronic address: Zuleyha.Cidav@pennmedicine.upenn.edu.'}, {'ForeName': 'Audreesh', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, 9th floor, 3737 Market Street, Philadelphia, PA 19104, USA. Electronic address: Audreesh.banerjee@pennmedicine.upenn.edu.'}, {'ForeName': 'A Russell', 'Initials': 'AR', 'LastName': 'Localio', 'Affiliation': 'Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, 600 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104, USA. Electronic address: rlocalio@pennmedicine.upenn.edu.'}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, 600 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104, USA. Electronic address: Knashawn.Morales@pennmedicine.upenn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106808']
1329,35644335,A prospective ex vivo biomechanical analysis of retrievable inferior vena cava filters.,"OBJECTIVE


In the present study, we investigated the structural integrity of inferior vena cava (IVC) filters after their retrieval.
METHODS


A prospective ex vivo biomechanical analysis was performed of the structural integrity of 100 IVC filters used in a randomized controlled trial to evaluate the effectiveness of prophylactic IVC filters in preventing mortality or symptomatic pulmonary embolism in major trauma patients.
RESULTS


Of the 100 included patients, 7 (7%) had required more than one attempt to remove the filter. The median duration of the filter left in situ was 54 days (interquartile range, 17-101 days). During the initial attempt to remove six filters (6%), thrombi were found entrapped and required 4 weeks of systemic anticoagulation therapy before the filters could be removed in a second attempt. A positive correlation was found between the duration of the filter left in situ and the loss in metallic elasticity of the nitinol alloy of the filter struts (Pearson correlation coefficient, 0.232; P = .008). One filter was adherent to the IVC wall and required open surgical removal 227 days after its initial placement. One of the six long struts of the filter had been fractured during the removal process, with evidence of hardening to bending stress in the remaining five struts of the fractured filter compared with the struts of the 25 intact filters. Fibrous endothelial tissue (73%) and thrombi (33%) adherent to the retrieved filters were frequently observed. The presence of adherent fibrous tissue was not significantly related statistically to the duration of the filter left in situ (P = .353) but was more common among the patients who had had a delay in receiving prophylactic anticoagulation therapy (mean difference, 2 days; 95% confidence interval, 0.6-3.3; P = .039).
CONCLUSIONS


Metallic fatigue might account for IVC filter strut fractures. Fibrous endothelial tissue adherent to the filters was common, especially for those with a delay in receiving prophylactic anticoagulation therapy.",2022,"There was a positive correlation between the duration of the filter left in situ and loss in metallic elasticity of the nitinol alloy of the filter struts (Pearson correlation coefficient = 0.232, P = 0.008).",['major trauma patients'],"['inferior vena cava (IVC) filters', 'retrievable inferior vena cava filters', 'prophylactic vena cava filters']","['Fibrous endothelial tissue', 'metallic elasticity', 'mortality or symptomatic pulmonary embolism']","[{'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0080306', 'cui_str': 'Vena cava filter'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}]",,0.0641451,"There was a positive correlation between the duration of the filter left in situ and loss in metallic elasticity of the nitinol alloy of the filter struts (Pearson correlation coefficient = 0.232, P = 0.008).","[{'ForeName': 'Kwok M', 'Initials': 'KM', 'LastName': 'Ho', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia; School of Veterinary and Life Sciences, Murdoch University, Perth, WA, Australia; Department of Intensive Care Medicine, Royal Perth Hospital, Perth, WA, Australia. Electronic address: kwok.ho@health.wa.gov.au.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chamberlain', 'Affiliation': 'Department of Intensive Care Medicine, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Nasim', 'Affiliation': 'Department of Surgery, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Frederick B', 'Initials': 'FB', 'LastName': 'Rogers', 'Affiliation': 'Department of Surgery, University of Pennsylvania, Lancaster, PA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kop', 'Affiliation': 'Department of Medical Engineering and Physics, Royal Perth Hospital, Perth, WA, Australia.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2022.04.007']
1330,35645222,Additional insulin dosing for fat and protein in children with type 1 diabetes using multiple daily injections.,"OBJECTIVE


High-fat high-protein (HFHP) meals are associated with post-prandial hyperglycemia in type 1 diabetes (T1D), administration of additional insulin for such meals is recommended in order to optimize glucose levels. Optimal timing of additional insulin for HFHP meals in children and young people receiving multiple daily injections (MDI) remains unclear.
AIM


To investigate the glycemic impact of additional insulin doses given before or after eating a HFHP meal in children with T1D using MDI.
RESEARCH DESIGN AND METHODS


A randomized, controlled three period crossover trial of 27 participants aged 13 years (6.1-17.7) at two Pediatric Diabetes centers was conducted. Additional rapid-acting insulin for the fat-protein content of a standardized HFHP meal was given at three time points        +   0     +   1     +   2     h     of     usual     pre   -   prandial carbohydrate     insulin     ;   $$ \left(+0,\kern0.5em +1,\kern0.5em +2\kern0.5em \mathrm{h}\kern0.5em \mathrm{of}\kern0.5em \mathrm{usual}\kern0.5em \mathrm{pre}\hbox{-} \mathrm{prandial}\ \mathrm{carbohydrate}\kern0.5em \mathrm{insulin}\right); $$    calculated using an algorithm extrapolated from current evidence base and clinical recommendations. Post-prandial glucose (PPG) parameters were calculated for 420 minutes using continuous glucose monitoring. The primary outcome was mean PPG excursion. Secondary outcomes included peak glucose, time to peak and hypoglycemia incidence.
RESULTS


There was no difference in post-prandial glucose parameters when additional HFHP insulin was administered at    +   0   ,     +   1   ,     or     +   2     h   :   $$ +0,\kern0.5em +1,\kern0.5em \mathrm{or}\kern0.5em +2\kern0.5em \mathrm{h}: $$    mean glucose excursion (mmol/L) (SE): 1.9(0.7), 1.2(0.7), 2.5(0.7); p = 0.5); mean peak glucose (mmol/L)(SE): 10.9(0.9), 11.5(0.8), 11.5(0.9); p = 0.9; time to peak glucose (mins)(SE): 82.3(35.4), 113.6(30.9), 95.1(32.1); p = 0.8. Mild hypoglycemia was common (55%) in all groups (p = 0.97).
CONCLUSION


We found no benefit in giving additional insulin as a split dose for HFHP meals in children using MDI, mild hypoglycemia was common. Future studies would benefit from refinement of the insulin dose algorithm.",2022,"There was no difference in post-prandial glucose parameters when additional HFHP insulin was administered at +0hr, +1hr or +2hr: mean glucose excursion (mmol/l)(SE): 1.9(0.7), 1.2(0.7), 2.5(0.7); P=0.5); mean peak glucose (mmol/l)(SE):","['Children with Type 1 Diabetes using Multiple Daily Injections', 'children with T1D using MDI', '27 participants aged 13yrs (6.1-17.7) at two Paediatric Diabetes centres was conducted', 'children and young people receiving multiple daily injections (MDI']","['High-fat high-protein (HFHP) meals', 'additional insulin for HFHP meals']","['mean peak glucose (mmol/l)(SE', 'post-prandial glucose parameters', 'time to peak glucose (mins)(SE', 'Post-prandial glucose (PPG) parameters', 'peak glucose, time to peak and hypoglycaemia incidence', 'mean PPG excursion', 'Mild hypoglycaemia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",27.0,0.121355,"There was no difference in post-prandial glucose parameters when additional HFHP insulin was administered at +0hr, +1hr or +2hr: mean glucose excursion (mmol/l)(SE): 1.9(0.7), 1.2(0.7), 2.5(0.7); P=0.5); mean peak glucose (mmol/l)(SE):","[{'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Frohock', 'Affiliation': 'Paediatric Dietetics, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Oke', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Yaliwal', 'Affiliation': ""Children's and Adolescent Services, Royal Berkshire Hospital NHS Trust, Reading, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Edge', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel E J', 'Initials': 'REJ', 'LastName': 'Besser', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}]",Pediatric diabetes,['10.1111/pedi.13372']
1331,35648636,Efficacy of Emotion-Focused Parenting Programs for Children's Internalizing and Externalizing Symptoms: A Randomized Clinical Study.,"OBJECTIVE


Emotion-Focused Skills Training (EFST) is a 12-week parental program based on Emotion-Focused Therapy, developed to improve children and adolescents' mental health problems.
METHODS


In a randomized clinical dismantling study, including parents of 236 children and adolescents (ages 6-13, M age  8.9, 60.6% boys, 95.8% Caucasian) with externalizing and/or internalizing problems within clinical range, we examined the efficacy of two versions of EFST: one  experiential  condition (n = 120) involving emotionally evocative techniques and two-chair interventions, and one  psychoeducational only  condition (n = 116) involving didactic teaching of emotion skills. Both groups received a 2-day group training and 6 hours of individual supervision. Outcomes were parent- and teacher-reported symptoms at baseline, posttreatment, and 4-, 8-, and 12-month follow-up. Analyses were conducted using multilevel growth curve modeling and Bayesian post hoc analysis.
RESULTS


EFST showed efficacy in reducing parent-reported externalizing ( b  = -1.72,  p  < .001,  d  = 1.0) and internalizing ( b  = -1.71,  p  < .001,  d  = 0.9) symptoms, and teacher-reported externalizing ( b  = -.96,  p  < .001,  d  = 0.4), but not internalizing ( b  = -.13,  p  > .05,  d  = 0.2) symptoms. Multilevel analyses showed nonsignificant differences between conditions (all  p 's > .05), although a Bayesian longitudinal sensitivity analysis indicated a better outcome for the  experiential  condition.
CONCLUSION


EFST showed efficacy in symptom reduction for children and adolescents with internalizing and externalizing symptoms. Outcomes were maintained over 12 months for both conditions, supporting EFST as a transdiagnostic parental approach for early intervention.",2022,"Outcomes were maintained over 12 months for both conditions, supporting EFST as a transdiagnostic parental approach for early intervention.","[""children and adolescents' mental health problems"", 'parents of 236 children and adolescents (ages 6-13, M age  8.9, 60.6% boys, 95.8% Caucasian) with externalizing and/or internalizing problems within clinical range', 'children and adolescents with internalizing and externalizing symptoms', ""Children's Internalizing and Externalizing Symptoms""]","['2-day group training and 6\xa0hours of individual supervision', 'Emotion-Focused Skills Training (EFST', 'EFST', 'EFST: one  experiential  condition (n\xa0=\xa0120) involving emotionally evocative techniques and two-chair interventions, and one  psychoeducational only  condition (n\xa0=\xa0116) involving didactic teaching of emotion skills', 'Emotion-Focused Parenting Programs']",['efficacy in reducing parent-reported externalizing'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",236.0,0.0815417,"Outcomes were maintained over 12 months for both conditions, supporting EFST as a transdiagnostic parental approach for early intervention.","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ansar', 'Affiliation': 'Department of Clinical Psychology, University of Oslo.'}, {'ForeName': 'Helene A', 'Initials': 'HA', 'LastName': 'Nissen Lie', 'Affiliation': 'Department of Clinical Psychology, University of Oslo.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Zahl-Olsen', 'Affiliation': 'Department of Child and Adolescent Mental Health, Sorlandet Hospital.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Bertelsen', 'Affiliation': 'Department of Child and Adolescent Mental Health, Sorlandet Hospital.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'School of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Jan Reidar', 'Initials': 'JR', 'LastName': 'Stiegler', 'Affiliation': 'Department of Research and Development, The Norwegian Institute of Emotion-Focused Therapy.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2022.2079130']
1332,35649713,ANT-DBS in epilepsy shows no effect on selected neuropsychiatric tests.,"OBJECTIVES


Deep brain stimulation of the anterior thalamic nucleus (ANT-DBS) is an established option in treatment-resistant epilepsy and obtained FDA approval in 2018. Increased psychiatric comorbidity is well known in epilepsy. The main objective of this study was to investigate possible neuropsychiatric treatment-related changes in patients receiving ANT-DBS.
MATERIALS AND METHODS


Bilateral ANT electrodes were implanted in 18 adult patients with refractory epilepsy in a randomized, double-blinded study. Immediately after implantation, patients were randomized to stimulation ON (n = 8) or OFF (n = 10) for the first 6 months (blinded phase). During the next six months (open phase), both groups received active stimulation. Neuropsychiatric assessment was conducted before implantation (T1), at the end of the blinded period (T2), and 1 year after implantation (T3).
RESULTS


Comparing preoperative status (T1) and 12 months (T3), postoperative outcome in all patients did not show significant differences between the two groups for any of the applied tests. Groupwise comparisons across the two first time points (the blinded period, representing the randomized controlled trial) showed no significant differences between the two groups in any of the neuropsychiatric parameters studied. Comparing test results after 6 months of stimulation in both groups (sum of ON group T1 to T2 and OFF group T2 to T3) did not show significant changes for any of the psychiatric assessments.
CONCLUSIONS


Our results indicate that ANT-DBS has limited effect concerning psychiatric issues. Subjective side effects were, however, reported in individual patients.",2022,"Comparing preoperative status (T1) and 12 months (T3), postoperative outcome in all patients did not show significant differences between the two groups for any of the applied tests.","['18 adult patients with refractory epilepsy', 'patients receiving ANT-DBS']","['anterior thalamic nucleus (ANT-DBS', 'ANT-DBS', 'active stimulation', 'OFF']","['Subjective side effects', 'psychiatric comorbidity', 'postoperative outcome']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0003455', 'cui_str': 'Family Formicidae'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0228316', 'cui_str': 'Structure of anterior nuclear group of thalamus'}, {'cui': 'C0003455', 'cui_str': 'Family Formicidae'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",18.0,0.237743,"Comparing preoperative status (T1) and 12 months (T3), postoperative outcome in all patients did not show significant differences between the two groups for any of the applied tests.","[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Herrman', 'Affiliation': 'Department of Neurology, Oslo University Hospital-Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kåre', 'Initials': 'K', 'LastName': 'Osnes', 'Affiliation': 'Division of Mental Health and Substance Abuse, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Arild', 'Initials': 'A', 'LastName': 'Egge', 'Affiliation': 'Department of Neurosurgery, Oslo University Hospital-Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Konglund', 'Affiliation': 'Department of Neurosurgery, Oslo University Hospital-Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ramm-Pettersen', 'Affiliation': 'Department of Neurosurgery, Oslo University Hospital-Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Dietrichs', 'Affiliation': 'Department of Neurology, Oslo University Hospital-Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Taubøll', 'Affiliation': 'Department of Neurology, Oslo University Hospital-Rikshospitalet, Oslo, Norway.'}]",Acta neurologica Scandinavica,['10.1111/ane.13658']
1333,35652747,Levels and dynamics of estimated glomerular filtration rate and recurrent vascular events and death in patients with minor stroke or transient ischemic attack.,"BACKGROUND AND PURPOSE


Impaired kidney function is associated with an increased risk of vascular events in acute stroke patients, when assessed by single measurements of estimated glomerular filtration rate (eGFR). It is unknown whether repeated measurements provide additional information for risk prediction.
METHODS


The MonDAFIS (Systematic Monitoring for Detection of Atrial Fibrillation in Patients with Acute Ischemic Stroke) study randomly assigned 3465 acute ischemic stroke patients to either standard procedures or an additive Holter electrocardiogram. Baseline eGFR (CKD-EPI formula) were dichotomized into values of < versus ≥60 ml/min/1.73 m 2  . eGFR dynamics were classified based on two in-hospital values as ""stable normal"" (≥60 ml/min/1.73 m 2  ), ""increasing"" (by at least 15% from baseline, second value ≥ 60 ml/min/1.73 m 2  ), ""decreasing"" (by at least 15% from baseline of ≥60 ml/min/1.73 m 2  ), and ""stable decreased"" (<60 ml/min/1.73 m 2  ). The composite endpoint (stroke, major bleeding, myocardial infarction, all-cause death) was assessed after 24 months. We estimated hazard ratios in confounder-adjusted models.
RESULTS


Estimated glomerular filtration rate at baseline was available in 2947 and a second value in 1623 patients. After adjusting for age, stroke severity, cardiovascular risk factors, and randomization, eGFR < 60 ml/min/1.73 m 2  at baseline (hazard ratio [HR] = 2.2, 95% confidence interval [CI] = 1.40-3.54) as well as decreasing (HR = 1.79, 95% CI = 1.07-2.99) and stable decreased eGFR (HR = 1.64, 95% CI = 1.20-2.24) were independently associated with the composite endpoint. In addition, eGFR < 60 ml/min/1.73 2  at baseline (HR = 3.02, 95% CI = 1.51-6.10) and decreasing eGFR were associated with all-cause death (HR = 3.12, 95% CI = 1.63-5.98).
CONCLUSIONS


In addition to patients with low eGFR levels at baseline, also those with decreasing eGFR have increased risk for vascular events and death; hence, repeated estimates of eGFR might add relevant information to risk prediction.",2022,"In addition, eGFR<60ml/min/1.73 2  at baseline (HR 3.02; 95%CI: 1.51-6.10) and ""decreasing"" eGFR were associated with all-cause death (HR 3.12; 95%CI: 1.63-5.98).
","['acute stroke patients', '1,623 patients', 'Patients with Minor Stroke or TIA', 'Patients with Acute Ischemic Stroke (MonDAFIS) study randomly assigned 3,465 acute ischemic-stroke patients to either']",['standard procedures or an additive Holter-ECG'],"['glomerular filtration rate (eGFR', 'decreasing"" eGFR', 'composite endpoint (stroke, major-bleeding, myocardial-infarction, all-cause death', 'Levels and Dynamics of estimated Glomerular Filtration Rate and Recurrent Vascular Events and Death', ' eGFR', 'Baseline eGFR (CKD-epi formula']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]",3465.0,0.212759,"In addition, eGFR<60ml/min/1.73 2  at baseline (HR 3.02; 95%CI: 1.51-6.10) and ""decreasing"" eGFR were associated with all-cause death (HR 3.12; 95%CI: 1.63-5.98).
","[{'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Tütüncü', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Manuel C', 'Initials': 'MC', 'LastName': 'Olma', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kunze', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Krämer', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Dietzel', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schurig', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Filser', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Waltraud', 'Initials': 'W', 'LastName': 'Pfeilschifter', 'Affiliation': 'Department of Neurology, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Gerhard F', 'Initials': 'GF', 'LastName': 'Hamann', 'Affiliation': 'Department of Neurology, BKH Günzburg, Günzburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Büttner', 'Affiliation': 'Department of Neurology, Hans-Susemihl Hospital, Emden, Germany.'}, {'ForeName': 'Peter U', 'Initials': 'PU', 'LastName': 'Heuschmann', 'Affiliation': 'Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': 'German Atrial Fibrillation Network, Münster, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Department of Cardiology, University Hospital of Leipzi, Leipzig, Germany.'}, {'ForeName': 'Darius G', 'Initials': 'DG', 'LastName': 'Nabavi', 'Affiliation': 'Department of Neurology, Vivantes Hospital Neukölln, Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Röther', 'Affiliation': 'Department of Neurology, Asklepios Clinic Altona, Hamburg, Germany.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Department of Neurology, Alfried Krupp Hospital, Essen, Germany.'}, {'ForeName': 'Kai-Uwe', 'Initials': 'KU', 'LastName': 'Eckardt', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Karl Georg', 'Initials': 'KG', 'LastName': 'Haeusler', 'Affiliation': 'Department of Neurology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.15431']
1334,35653611,The Effects of a Prenatal Mindfulness Intervention on Infant Autonomic and Behavioral Reactivity and Regulation.,"OBJECTIVE


Maternal health and wellness during pregnancy are associated with long-term health outcomes in children. The current study examined whether infants of women who participated in a mindfulness-based intervention during pregnancy that reduced levels of stress and depression, increased physical activity, and improved glucose tolerance differed on biobehavioral markers of psychopathological and physical health risk compared with infants of women who did not.
METHODS


Participants were 135 mother-infant dyads drawn from a racially and ethnically diverse, low-income sample experiencing high stress. The women participated in an intervention trial during pregnancy that involved assignment to either mindfulness-based intervention or treatment-as-usual (TAU). Infants of women from both groups were assessed at 6 months of age on sympathetic (preejection period), parasympathetic (respiratory sinus arrhythmia), and observed behavioral (negativity and object engagement) reactivity and regulation during the still face paradigm. Linear mixed-effects and generalized linear mixed-effects models were used to examine treatment group differences in infant outcomes.
RESULTS


Relative to those in the intervention group, infants in the TAU group showed a delay in sympathetic activation and subsequent recovery across the still face paradigm. In addition, infants in the intervention group engaged in higher proportions of self-regulatory behavior during the paradigm, compared with the TAU group. No significant effect of intervention was found for parasympathetic response or for behavioral negativity during the still face paradigm.
CONCLUSIONS


Findings provide evidence that maternal participation in a short-term, group mindfulness-based intervention during pregnancy is associated with the early development of salutary profiles of biobehavioral reactivity and regulation in their infants. Because these systems are relevant for psychopathology and physical health, prenatal behavioral interventions may benefit two generations.",2022,"No significant effect of intervention was found for parasympathetic response or for behavioral negativity during the still face paradigm.
","['children', 'infants of women who participated in a', 'Participants were 135 mother-infant dyads drawn from a racially and ethnically diverse, low-income sample experiencing high stress']","['mindfulness-based intervention or treatment-as-usual (TAU', 'Prenatal Mindfulness Intervention', 'mindfulness-based intervention']","['stress and depression, increased physical activity, and improved glucose tolerance', 'higher proportions of self-regulatory behavior', 'parasympathetic response or for behavioral negativity', 'delay in sympathetic activation and subsequent recovery', 'sympathetic (preejection period), parasympathetic (respiratory sinus arrhythmia), and observed behavioral (negativity and object engagement) reactivity and regulation', 'biobehavioral markers of psychopathological and physical health risk', 'Infant Autonomic and Behavioral Reactivity and Regulation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",135.0,0.0244636,"No significant effect of intervention was found for parasympathetic response or for behavioral negativity during the still face paradigm.
","[{'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Noroña-Zhou', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences, Center for Health and Community, Weill Institute for Neurosciences (Noroña-Zhou, Coccia, Epel, Adler, Bush), University of California, San Francisco, San Francisco; Division of Physical Sciences (Vieten), University of California, San Diego, San Diego, California; John W. Brick Mental Health Foundation (Vieten), Timonium, Maryland; Institute of Noetic Sciences (Vieten), Petaluma; Department of Pediatrics (Adler, Bush), University of California, San Francisco, San Francisco; School of Public Health (Laraia), University of California, Berkeley, Berkeley; Center for Health and Community, Weill Institute for Neurosciences (Jones-Mason), Department of Family Health Care Nursing (Alkon), and Department of Pediatrics, Division of Developmental Medicine (Bush), University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coccia', 'Affiliation': ''}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Epel', 'Affiliation': ''}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Vieten', 'Affiliation': ''}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Adler', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Laraia', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jones-Mason', 'Affiliation': ''}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Alkon', 'Affiliation': ''}, {'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Bush', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000001066']
1335,35654284,Randomized controlled trial of Sunnyside: Individual versus group-based online interventions to prevent postpartum depression.,"BACKGROUND


Postpartum depression (PPD) is a serious mental health problem that has a prevalence rate of nearly 20% in the first three months after delivery. The purpose of this study was to evaluate the benefit of Sunnyside, an internet-based cognitive-behavioral intervention, delivered in a group format compared to the same intervention delivered individually for the prevention of PPD.
METHOD


210 people between 20- and 28-weeks gestation and who scored between 5 and 14 on the PHQ-8 and who did not meet criteria for major depression were recruited online. The Inventory of Depression and Anxiety Symptoms (IDAS), the Hamilton Rating Scale for Depression (HAMD), and the depression and anxiety modules of the MINI were obtained at baseline, post-treatment, and 12-weeks postpartum. Intervention adherence was measured by site usage.
RESULTS


Across self-report and interview measures of depression there were no significant differences in outcome between the group and the individual versions of the program. Rates of major depression and generalized anxiety disorder in the postpartum period were low and adherence to the conditions was similarly high. Participants in the individual condition were significantly more satisfied than participants in the group condition (p < 0.05).
LIMITATIONS


The sample was predominantly white (85%) and recruited online, which may limit generalizability.
CONCLUSIONS


The group intervention was not more effective than the individual intervention. However, ignoring groups, many measures improved over time. The results of this study provide evidence that mood symptoms improve when participating in an online preventive intervention for postpartum depression.",2022,Across self-report and interview measures of depression there were no significant differences in outcome between the group and the individual versions of the program.,['210 people between 20- and 28-weeks gestation and who scored between 5 and 14 on the PHQ-8 and who did not meet criteria for major depression were recruited online'],['Sunnyside: Individual versus group-based online interventions'],"['Intervention adherence', 'Inventory of Depression and Anxiety Symptoms (IDAS), the Hamilton Rating Scale for Depression (HAMD), and the depression and anxiety modules of the MINI', 'Rates of major depression and generalized anxiety disorder']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]",210.0,0.0555878,Across self-report and interview measures of depression there were no significant differences in outcome between the group and the individual versions of the program.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Duffecy', 'Affiliation': 'University of Illinois - Chicago, Department of Psychiatry, United States of America. Electronic address: jduffecy@uic.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Grekin', 'Affiliation': 'University of Iowa, Department of Psychological and Brain Sciences, United States of America.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Long', 'Affiliation': 'University of Iowa, Department of Psychiatry, United States of America; University of Iowa, Department of Biostatistics, United States of America.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Mills', 'Affiliation': 'University of Iowa, Department of Psychiatry, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Hara"", 'Affiliation': 'University of Iowa, Department of Psychological and Brain Sciences, United States of America.'}]",Journal of affective disorders,['10.1016/j.jad.2022.05.123']
1336,35654673,Shear bond strength of metallic orthodontic brackets to zirconium crowns treated by sandblasting compared to enamel using a universal adhesive: An in vitro study.,"OBJECTIVES


Orthodontic brackets are increasingly bonded to the surface of zirconium crowns due to the growing aesthetic demands in adults' restorations. Therefore, providing a reliable bond between these substrates is of great importance. This study aimed at investigating the shear bond strength (SBS) of orthodontic metal brackets bonded to zirconium treated by sandblasting. In addition, the value was compared with SBS between metal brackets and enamel.
MATERIALS AND METHODS


Samples were divided into three groups including first premolar enamel specimens (n=20), untreated zirconium blocks (n=20) and sandblasted zirconium blocks (n=20). Enamel specimens underwent etching and bonding procedures using 37% phosphoric acid and 3M™ Scotchbond™ Universal adhesive. Zirconium blocks were randomly allocated to two groups. The first group was prepared by sandblasting with 50μm aluminium oxide particles (Al 2 O 3 ) under 4 bars pressure followed by bonding brackets with 3M™ Scotchbond™ Universal adhesive. Metal brackets were also bonded to the untreated zirconium group using the same adhesive. All samples underwent thermocycling, and SBS was calculated using a universal testing machine with a crosshead speed of 1mm/min. Data were analysed using One-way Anova and Tukey's tests.
RESULTS


The highest SBS was recorded in sandblasted zirconium group (26.17±8.22MPa) followed by enamel group (23.667±7.00MPa) and untreated zirconium group (11.49±7.00MPa). There was a significant difference between the SBS of untreated zirconium and that of two other groups.
CONCLUSION


Perfect SBS was achieved by sandblasting pre-treatment, comparable to that of enamel. Therefore, sandblasting of zirconium crowns is recommended prior to bonding orthodontic brackets.",2022,The highest SBS was recorded in sandblasted zirconium group (26.17±8.22MPa) followed by enamel group (23.667±7.00MPa) and untreated zirconium group (11.49±7.00MPa).,['Samples were divided into three groups including first premolar enamel specimens (n=20'],"['untreated zirconium blocks (n=20) and sandblasted zirconium blocks', 'zirconium crowns', 'phosphoric acid and 3M™ Scotchbond™ Universal adhesive', '50μm aluminium oxide particles']","['highest SBS', 'Perfect SBS', 'Shear bond strength of metallic orthodontic brackets', 'shear bond strength (SBS']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}]","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0043506', 'cui_str': 'Zirconium'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C0074197', 'cui_str': 'Scotchbond'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0002374', 'cui_str': 'Aluminum Oxide'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0085428', 'cui_str': 'Orthodontic bracket'}]",,0.0540463,The highest SBS was recorded in sandblasted zirconium group (26.17±8.22MPa) followed by enamel group (23.667±7.00MPa) and untreated zirconium group (11.49±7.00MPa).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Namvar', 'Affiliation': 'Private practice orthodontist, Tehran, Iran.'}, {'ForeName': 'Mansoure Zarmehi', 'Initials': 'MZ', 'LastName': 'Shahrebabak', 'Affiliation': 'School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Arab', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam Abdoh', 'Initials': 'MA', 'LastName': 'Tabrizi', 'Affiliation': 'Department of Operative Dentistry, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Department of Operative Dentistry and Dental Research Centre, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Safari', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: safarii_fatemeh@yahoo.com.'}]",International orthodontics,['10.1016/j.ortho.2022.100640']
1337,35662036,Epidural blood patch in the treatment of severe post dural puncture headache after spinal anesthesia: A rare case report.,"INTRODUCTION AND IMPORTANCE


Spinal anesthesia is a type of regional anesthesia that involves injecting a local anesthetic directly into the cerebrospinal fluid. In Ethiopia, the prevalence of PDPH was 42.6%, with large spinal needles and repeated attempts being independently associated risk factors.
CASE PRESENTATION


A 20-year-old woman is undergoing a cesarean section while under spinal anesthesia. On the second postoperative day, the patient begins to complain of PDPH-like headaches. The headache was severe according to the VAS score, and the team attempted to manage it using the WHO analgesic ladder, but it was refractory to supportive and pharmaceutical therapy. We then used EPDBP, and the headache was promptly reduced. The treatment had a considerable impact on the movement, satisfaction, and discharge conditions of the patients.
CLINICAL DISCUSSION


A prospective research conducted in Helsinki found that EBP was effective in 88-96% of the patients in the various study groups. One randomized, double-blind trial on the therapeutic efficacy of EPDBP found that it is an effective treatment for PDPH. It provides complete symptom relief in a high number of people. In the remaining patients, it lessens the severity of their headaches and allows them to resume their normal activities. An epidural blood patch is a highly successful treatment option for a subset of people suffering from post-Dural puncture headache. It is an elective procedure with a low risk of complications.
CONCLUSION


The epidural blood patch procedure that we use proved helpful in treating severe PDPH after spinal anesthesia for cesarean delivery. There were no complications associated with the procedure until she was discharged from the hospital.",2022,An epidural blood patch is a highly successful treatment option for a subset of people suffering from post-Dural puncture headache.,"['A 20-year-old woman is undergoing a cesarean section while under spinal anesthesia', 'severe post dural puncture headache after spinal anesthesia']","['EBP', 'Epidural blood patch', 'EPDBP', 'epidural blood patch']","['movement, satisfaction, and discharge conditions of the patients']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}]","[{'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0186221,An epidural blood patch is a highly successful treatment option for a subset of people suffering from post-Dural puncture headache.,"[{'ForeName': 'Mekuanint', 'Initials': 'M', 'LastName': 'Asmare', 'Affiliation': 'Finote Selam General Hospital, Amhara Region Health bureau Department of Anesthesia, Ethiopia.'}, {'ForeName': 'Liyew', 'Initials': 'L', 'LastName': 'Ewnetu', 'Affiliation': 'Finote Selam General Hospital, Amhara Region Health bureau Department of Obstetrics and Gynecology, Ethiopia.'}, {'ForeName': 'Kumlachew', 'Initials': 'K', 'LastName': 'Geta', 'Affiliation': 'Department of Anesthesia, College of Health Sciences, School of Medicine, DebreTabor University, Ethiopia. Electronic address: Kumlachew.kg@gmail.com.'}]",International journal of surgery case reports,['10.1016/j.ijscr.2022.107256']
1338,35662019,Effects of manual massage given by family caregivers for patients with dementia: A preliminary investigation.,"OBJECTIVES


To explore the effects of a 10-week manual massage intervention given by caregivers of patients with dementia on the behavioral and psychological symptoms of dementia (BPSD) and caregiver burden.
METHODS


Twelve pairs of participants-patients with dementia and their family caregivers-were recruited. Before the intervention, caregivers received a four-hour full body manual massage training course. Thereafter, the caregivers gave a 30-min massage to the patients once a week for a 10-week period. The Cornell Scale for Depression in Dementia, Cohen-Mansfield Agitation Inventory, and Zarit Burden Scale were administered pre- and post-intervention.
RESULTS


Total scores on all questionnaires significantly decreased after the intervention (p < .05). Moreover, two subscale scores of the Cornell Scale for Depression in Dementia-behavioral disturbance and physical signs-reduced significantly (p < .05).
CONCLUSIONS


This study provides preliminary evidence on the benefits of manual massage given by caregivers for the management of BPSD and caregiver burden.",2022,"RESULTS


Total scores on all questionnaires significantly decreased after the intervention (p < .05).","['caregivers of patients with dementia on the behavioral and psychological symptoms of dementia (BPSD) and caregiver burden', 'Twelve pairs of participants-patients with dementia and their family caregivers-were recruited', 'patients with dementia']","['manual massage intervention', 'manual massage']","['Cornell Scale for Depression in Dementia, Cohen-Mansfield Agitation Inventory, and Zarit Burden Scale', 'Cornell Scale for Depression in Dementia-behavioral disturbance and physical signs']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]",12.0,0.0368242,"RESULTS


Total scores on all questionnaires significantly decreased after the intervention (p < .05).","[{'ForeName': 'Yi-Chien', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Cardinal Tien Hospital, New Taipei, Taiwan; Medical school of Fu-Jen University, New Taipei, Taiwan.'}, {'ForeName': 'Chih-Ning', 'Initials': 'CN', 'LastName': 'Liao', 'Affiliation': 'Department of Long-Term Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Chen-Yi', 'Initials': 'CY', 'LastName': 'Song', 'Affiliation': 'Department of Long-Term Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan. Electronic address: cysong@ntunhs.edu.tw.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.05.006']
1339,35662680,Parenting Acceptance and Commitment Therapy: An RCT of an online course with families of children with CP.,"AIM


To test an online course Parenting Acceptance and Commitment Therapy (PACT) in an RCT with families of children with cerebral palsy (CP), predicting improvements in emotional availability and parent and child adjustment.
METHOD


67 families of children (2-10 years) with CP participated. Families were randomly assigned to waitlist control or PACT. Assessments at baseline, post-intervention and at six-month follow up (durability of intervention effects) focussed on emotional availability, adjustment and quality of life. Analysis consisted of repeated measure linear regression models.
RESULTS


At postintervention (T2), an intervention effect was demonstrated for two aspects of observed emotional availability: parental non-intrusiveness MD = 0.68 (-0.56 to 1.92), p = 0.050 and child involvement, MD = 0.91 (-0.36 to 2.18), p = 0.011. An intervention effect was also found for the parent-reported emotional availability in terms of child involvement. Further intervention effects were found in parent-report measures of child quality of life (social wellbeing and acceptance, participation and physical health), parental mindfulness, parental acceptance, support, social connection, and meaning. No effects were found on parent or child adjustment. Analyses focussed on durability of intervention effect, collapsed across groups, indicated that effects persisted at 6 month follow up (T4).
INTERPRETATION


PACT demonstrated an intervention effect for two aspects of emotional availability-parental non-intrusiveness and child involvement-as well as parental mindfulness and child quality of life. Parents reported increased comfort with the CP diagnosis, higher likelihood to seek support, higher likelihood to stay connected to others and greater meaningful living. PACT is an effective online/telehealth parenting support intervention for parents of children with CP.",2022,"INTERPRETATION


PACT demonstrated an intervention effect for two aspects of emotional availability-parental non-intrusiveness and child involvement-as well as parental mindfulness and child quality of life.","['parents of children with CP', '67 families of children (2-10 years) with CP participated', 'RCT with families of children with cerebral palsy (CP', 'families of children with CP']","['online course Parenting Acceptance and Commitment Therapy (PACT', 'waitlist control or PACT', 'PACT', 'Parenting Acceptance and Commitment Therapy']","['child quality of life (social wellbeing and acceptance, participation and physical health), parental mindfulness, parental acceptance, support, social connection, and meaning', 'emotional availability, adjustment and quality of life']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3696958', 'cui_str': 'Social wellbeing'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",67.0,0.0214264,"INTERPRETATION


PACT demonstrated an intervention effect for two aspects of emotional availability-parental non-intrusiveness and child involvement-as well as parental mindfulness and child quality of life.","[{'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Australia. Electronic address: koawhittingham@uq.edu.au.'}, {'ForeName': 'Jeanie', 'Initials': 'J', 'LastName': 'Sheffield', 'Affiliation': 'School of Psychology, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mak', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}]",Behaviour research and therapy,['10.1016/j.brat.2022.104129']
1340,35642490,Mat Pilates training reduces blood pressure in both well-controlled hypertensive and normotensive postmenopausal women: a controlled clinical trial study.,"AIM


The aim of this study was to compare the Mat Pilates training-induced responses in resting and ambulatory blood pressure monitoring (ABPM), blood pressure variability (BPV), and heart rate variability (HRV) in well-controlled hypertensive and normotensive postmenopausal women.
METHODS


Forty-seven postmenopausal women were allocated in well-controlled hypertensive (HT) and normotensive (NT) groups. The exercise program was performed three times a week for 12 weeks. Before and after the intervention resting, blood pressure (BP), ABPM, HRV, and BPV were analyzed.
RESULTS


Student's  t -test showed no difference in baseline anthropometric and resting BP values between groups. The generalized estimation equation (GEE) showed no interactions (group*time), but time (p < .05) reductions in resting systolic, diastolic and mean BP after training in both groups. Sleep ambulatory systolic, diastolic and mean BP were higher overall in the HT group (p < .05 in group effect). We also found a time effect (p < .05) with significant increases in BPV in the mean diurnal and nocturnal deviations weighted for the duration of the daytime and nighttime interval (SDdn) in systolic, diastolic and mean BP, and in the average real variability (ARV) in diastolic and mean in both groups. In addition, HRV increases (p < .05 in time effect) through the percentage of pairs of adjacent RR intervals with a difference of at least 50 ms (pNN50) after training in both groups.
CONCLUSION


Both normotensive and well-controlled hypertensive postmenopausal women may have similar Mat Pilates exercise training-induced responses in ambulatory BP, BPV and HRV.",2022,"Sleep ambulatory systolic, diastolic and mean BP were higher overall in the HT group (p < .05 in group effect).","['Both normotensive and well-controlled hypertensive postmenopausal women', 'both well-controlled hypertensive and normotensive postmenopausal women', 'well-controlled hypertensive and normotensive postmenopausal women', 'Forty-seven postmenopausal women were allocated in well-controlled hypertensive (HT) and normotensive (NT) groups']","['Mat Pilates training', 'Mat Pilates training-induced responses in resting and ambulatory blood pressure monitoring (ABPM']","['BPV', 'blood pressure variability (BPV), and heart rate variability (HRV', 'Sleep ambulatory systolic, diastolic and mean BP', 'daytime and nighttime interval (SDdn) in systolic, diastolic and mean BP, and in the average real variability (ARV', 'resting systolic, diastolic and mean BP', 'baseline anthropometric and resting BP values', 'ambulatory BP, BPV and HRV', 'blood pressure', 'blood pressure (BP), ABPM, HRV, and BPV']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}]",47.0,0.0426605,"Sleep ambulatory systolic, diastolic and mean BP were higher overall in the HT group (p < .05 in group effect).","[{'ForeName': 'Jaqueline Pontes', 'Initials': 'JP', 'LastName': 'Batista', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Julia Buiatte', 'Initials': 'JB', 'LastName': 'Tavares', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Ludimila Ferreira', 'Initials': 'LF', 'LastName': 'Gonçalves', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Tállita Cristina Ferreira', 'Initials': 'TCF', 'LastName': 'de Souza', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Igor Moraes', 'Initials': 'IM', 'LastName': 'Mariano', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Mateus de Lima', 'Initials': 'ML', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Larissa Aparecida Santos', 'Initials': 'LAS', 'LastName': 'Matias', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Magalhães Resende', 'Affiliation': 'Physical Therapy Department, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Guilherme Morais', 'Initials': 'GM', 'LastName': 'Puga', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education Department, Federal University of Uberlândia, Uberlândia, Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2022.2079670']
1341,35643952,Sequential eradication of Helicobacter pylori as a treatment for immune thrombocytopenia in patients with moderate thrombocytopenia: a multicenter prospective randomized phase 3 study.,"Due to several issues, standard treatments are not recommended for asymptomatic patients with moderate immune thrombocytopenia (ITP). Since platelet responses are reported in some patients with Helicobacter pylori (H. pylori)-positive ITP after eradication, we conducted a multicenter, phase 3 study to evaluate the safety and efficacy of recently established sequential eradication for these patients having moderate thrombocytopenia. Persistent or chronic ITP patients with platelet count (30 × 10 3  ~ 80 × 10 3 /μL) and confirmed active H. pylori infection were randomly assigned to a treatment and a control group. The former received 10-day sequential treatment. Eradication was assessed by urea breath test at 3 months after treatment. Primary endpoint was the overall platelet response rate at 3 months in successfully eradicated treatment group and control group. Secondary endpoints were platelet response time, H. pylori eradication success rate, etc. The patient enrollment terminated early because of the change of national insurance and treatment guideline for H. pylori-positive patients in Korea during the study. Of the 28 H. pylori-positive ITP patients, 17 were randomized to the treatment group, and eradication was achieved for 15 (88.2%) at 3 months, and seven in control group after withdrawal. Statistically, significant difference in platelet response rates between the two groups were observed (p = 0.017). Our study verifies that H. pylori eradication was an effective ITP treatment for patients with H. pylori-associated moderate ITP. This sequential eradication regimen showed not only a high H. pylori eradication rate, but also a remarkable platelet response for ITP patients. Trial registration number and date of registration for these prospectively registered trials is ClinicalTrials.gov number, NCT03177629 and June 6, 2017.",2022,"This sequential eradication regimen showed not only a high H. pylori eradication rate, but also a remarkable platelet response for ITP patients.","['Persistent or chronic ITP patients with platelet count (30\u2009×\u200910 3 \u2009~\u200980\u2009×\u200910 3 /μL) and confirmed active H. pylori infection', 'patients with moderate thrombocytopenia', 'patients with Helicobacter pylori (H. pylori)-positive ITP after eradication', '28 H. pylori-positive ITP patients', 'patients having moderate thrombocytopenia', 'asymptomatic patients with moderate immune thrombocytopenia (ITP', 'patients with H. pylori-associated moderate ITP']",[],"['platelet response rates', 'overall platelet response rate', 'eradication', 'platelet response time, H. pylori eradication success rate, etc', 'Eradication', 'high H. pylori eradication rate', 'urea breath test']","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",[],"[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}]",,0.0515361,"This sequential eradication regimen showed not only a high H. pylori eradication rate, but also a remarkable platelet response for ITP patients.","[{'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Hyo Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Ho-Young', 'Initials': 'HY', 'LastName': 'Yhim', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Doyeun', 'Initials': 'D', 'LastName': 'Oh', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Sung Hwa', 'Initials': 'SH', 'LastName': 'Bae', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Daegu Catholic University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Won-Sik', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Republic of Korea.'}, {'ForeName': 'JiHyun', 'Initials': 'J', 'LastName': 'Kwon', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.'}, {'ForeName': 'Jeong-Ok', 'Initials': 'JO', 'LastName': 'Lee', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Hwa Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Prevention Medicine, University of Ulsan College of Medicine, Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Mee', 'Initials': 'SM', 'LastName': 'Bang', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea. smbang7@snu.ac.kr.'}]",Annals of hematology,['10.1007/s00277-022-04782-2']
1342,35644672,"Immunogenicity and safety of double dosage of pneumococcal vaccines in adult kidney transplant recipients and waiting list patients: A non-blinded, randomized clinical trial.","BACKGROUND


Pneumococcal prime-boost vaccination is recommended for solid organ transplant recipients, but is not thoroughly tested in this population. Furthermore, a pneumococcal vaccine dose effect has never been investigated, though observed in healthy adults. To assess whether a double dose of 13-valent pneumococcal conjugate vaccine (PCV13) and of 23-valent pneumococcal polysaccharide vaccine (PPV23) increases the immunogenicity of prime-boost vaccination in kidney transplant recipients (KTRs) and patients on the kidney transplant waiting list (WLPs), a phase 3, randomized, non-blinded trial was conducted.
METHODS


KTRs and WLPs were in parallel groups assigned either normal or double dosage of both vaccines 12 weeks apart. A 'protective response' was an average geometric mean concentration ≥ 1 mg/L based on 12 vaccine shared serotype-specific IgG antibodies. Furthermore, number of antibodies with ≥ 2-fold rises and individual serotype-specific antibody concentrations were evaluated. Follow-up was 48 weeks.
RESULTS


Seventy-four KTRs and 65 WLPs were enrolled. In WLPs, double dosage resulted in a significantly higher proportion of participants with a 'protective response' (66.7%), 5 weeks after PPV23, compared to normal dosage (35.5%), p = 0.015. KTRs exhibited no dose effect. After PPV23, all four groups had increased their number of serotypes with ≥ 2-fold rises (p ≤ 0.05 for both WLPs groups; p ≤ 0.01 for both KTRs groups). Vaccines were safe, well tolerated and still immunogenic at week 48.
CONCLUSIONS


Data suggests that double dosage of pneumococcal vaccines used according to the prime-boost strategy might be recommendable for WLPs. Furthermore, our data supports PPV23́s additive effect to PCV13 in KTRs and WLPs. (EudraCT: 2016-004123-23).",2022,"After PPV23, all four groups had increased their number of serotypes with ≥ 2-fold rises (p ≤ 0.05 for both WLPs groups; p ≤ 0.01 for both KTRs groups).","['healthy adults', 'kidney transplant recipients (KTRs) and patients on the kidney transplant waiting list (WLPs', 'adult kidney transplant recipients and waiting list patients', 'Seventy-four KTRs and 65 WLPs were enrolled', 'solid organ transplant recipients']","['pneumococcal vaccines', '23-valent pneumococcal polysaccharide vaccine (PPV23', '13-valent pneumococcal conjugate vaccine (PCV13']","['safe, well tolerated and still immunogenic', 'Immunogenicity and safety', 'protective response', 'number of serotypes with\xa0≥\xa02-fold rises', 'immunogenicity of prime-boost vaccination', 'number of antibodies with\xa0≥\xa02-fold rises and individual serotype-specific antibody concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0730400', 'cui_str': 'Solid organ transplant'}]","[{'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}, {'cui': 'C0961101', 'cui_str': '23-valent pneumococcal capsular polysaccharide vaccine'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.339497,"After PPV23, all four groups had increased their number of serotypes with ≥ 2-fold rises (p ≤ 0.05 for both WLPs groups; p ≤ 0.01 for both KTRs groups).","[{'ForeName': 'Lykke', 'Initials': 'L', 'LastName': 'Larsen', 'Affiliation': 'Department of Infectious Diseases, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; OPEN, Open Patient Data Explorative Network, Odense University Hospital, Region of Southern Denmark. Electronic address: lykke.larsen@rsyd.dk.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bistrup', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Nephrology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Søren Schwartz', 'Initials': 'SS', 'LastName': 'Sørensen', 'Affiliation': 'Department of Nephrology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Boesby', 'Affiliation': 'Department of Medicine, Zealand University Hospital Roskilde, Roskilde, Denmark.'}, {'ForeName': 'Charlotte Sværke', 'Initials': 'CS', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Virus and Microbiological Special Diagnostics, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Isik Somuncu', 'Initials': 'IS', 'LastName': 'Johansen', 'Affiliation': 'Department of Infectious Diseases, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",Vaccine,['10.1016/j.vaccine.2022.05.040']
1343,35648794,"Efficacy of rupatadine in reducing the incidence of dengue haemorrhagic fever in patients with acute dengue: A randomised, double blind, placebo-controlled trial.","BACKGROUND


Rupatadine was previously shown to reduce endothelial dysfunction in vitro, reduced vascular leak in dengue mouse models and to reduce the extent of pleural effusions and thrombocytopenia in patients with acute dengue. Therefore, we sought to determine the efficacy of rupatadine in reducing the incidence of dengue haemorrhagic fever (DHF) in patients with acute dengue.
METHODS AND FINDINGS


A phase 2, randomised, double blind, placebo controlled clinical trial was carried out in patients with acute dengue in Sri Lanka in an outpatient setting. Patients with ≤3 days since the onset of illness were either recruited to the treatment arm of oral rupatadine 40mg for 5 days (n = 123) or the placebo arm (n = 126). Clinical and laboratory features were measured daily to assess development of DHF and other complications. 12 (9.7%) patients developed DHF in the treatment arm compared to 22 (17.5%) who were on the placebo although this was not significant (p = 0.09, relative risk 0.68, 95% CI 0.41 to 1.08). Rupatadine also significantly reduced (p = 0.01) the proportion of patients with platelet counts <50,000 cells/mm3 and significantly reduced (p = 0.04) persisting vomiting, headache and hepatic tenderness (p<0.0001) in patients. There was a significant difference in the duration of illness (p = 0.0002) although the proportion of individuals who required hospital admission in both treatment arms. Only 2 patients on rupatadine and 3 patients on the placebo developed shock, while bleeding manifestations were seen in 6 patients on rupatadine and 7 patients on the placebo.
CONCLUSIONS


Rupatadine appeared to be safe and well tolerated and showed a trend towards a reducing proportion of patients with acute dengue who developed DHF. Its usefulness when used in combination with other treatment modalities should be explored.
TRIAL REGISTRATION


International Clinical Trials Registration Platform: SLCTR/2017/024.",2022,"Rupatadine also significantly reduced (p = 0.01) the proportion of patients with platelet counts <50,000 cells/mm3 and significantly reduced (p = 0.04) persisting vomiting, headache and hepatic tenderness (p<0.0001) in patients.","['Patients with ≤3 days since the onset of illness', 'patients with acute dengue who developed DHF', 'patients with acute dengue', 'patients with acute dengue in Sri Lanka in an outpatient setting']","['oral rupatadine', 'placebo', 'rupatadine']","['shock, while bleeding manifestations', 'Rupatadine', 'duration of illness', 'vomiting, headache and hepatic tenderness', 'DHF', 'safe and well tolerated', 'hospital admission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0019100', 'cui_str': 'Dengue hemorrhagic fever'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0534301', 'cui_str': 'rupatadine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0534301', 'cui_str': 'rupatadine'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0151767', 'cui_str': 'Liver tender'}, {'cui': 'C0019100', 'cui_str': 'Dengue hemorrhagic fever'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.63622,"Rupatadine also significantly reduced (p = 0.01) the proportion of patients with platelet counts <50,000 cells/mm3 and significantly reduced (p = 0.04) persisting vomiting, headache and hepatic tenderness (p<0.0001) in patients.","[{'ForeName': 'Gathsaurie Neelika', 'Initials': 'GN', 'LastName': 'Malavige', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Chandima', 'Initials': 'C', 'LastName': 'Jeewandara', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Wijewickrama', 'Affiliation': 'National Institute of Infectious Diseases, Angoda, Sri Lanka.'}, {'ForeName': 'Dumni', 'Initials': 'D', 'LastName': 'Gunasinghe', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Sameera D', 'Initials': 'SD', 'LastName': 'Mahapatuna', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Chathurika', 'Initials': 'C', 'LastName': 'Gangani', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Vimalahan', 'Initials': 'V', 'LastName': 'Vimalachandran', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Geethal', 'Initials': 'G', 'LastName': 'Jayarathna', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Yashoda', 'Initials': 'Y', 'LastName': 'Perera', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Chandanie', 'Initials': 'C', 'LastName': 'Wanigatunga', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Dissanayake', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Shamini', 'Initials': 'S', 'LastName': 'Prathapan', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Eranga', 'Initials': 'E', 'LastName': 'Narangoda', 'Affiliation': 'National Institute of Infectious Diseases, Angoda, Sri Lanka.'}, {'ForeName': 'Damayanthi', 'Initials': 'D', 'LastName': 'Idampitiya', 'Affiliation': 'National Institute of Infectious Diseases, Angoda, Sri Lanka.'}, {'ForeName': 'Laksiri', 'Initials': 'L', 'LastName': 'Gomes', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Samurdhi', 'Initials': 'S', 'LastName': 'Wickramanayake', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Pramodth', 'Initials': 'P', 'LastName': 'Sahabandu', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Ogg', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0010123']
1344,35650437,Combination anti-HIV antibodies provide sustained virological suppression.,"Antiretroviral therapy is highly effective in suppressing human immunodeficiency virus (HIV) 1 . However, eradication of the virus in individuals with HIV has not been possible to date 2 . Given that HIV suppression requires life-long antiretroviral therapy, predominantly on a daily basis, there is a need to develop clinically effective alternatives that use long-acting antiviral agents to inhibit viral replication 3 . Here we report the results of a two-component clinical trial involving the passive transfer of two HIV-specific broadly neutralizing monoclonal antibodies, 3BNC117 and 10-1074. The first component was a randomized, double-blind, placebo-controlled trial that enrolled participants who initiated antiretroviral therapy during the acute/early phase of HIV infection. The second component was an open-label single-arm trial that enrolled individuals with viraemic control who were naive to antiretroviral therapy. Up to 8 infusions of 3BNC117 and 10-1074, administered over a period of 24 weeks, were well tolerated without any serious adverse events related to the infusions. Compared with the placebo, the combination broadly neutralizing monoclonal antibodies maintained complete suppression of plasma viraemia (for up to 43 weeks) after analytical treatment interruption, provided that no antibody-resistant HIV was detected at the baseline in the study participants. Similarly, potent HIV suppression was seen in the antiretroviral-therapy-naive study participants with viraemia carrying sensitive virus at the baseline. Our data demonstrate that combination therapy with broadly neutralizing monoclonal antibodies can provide long-term virological suppression without antiretroviral therapy in individuals with HIV, and our experience offers guidance for future clinical trials involving next-generation antibodies with long half-lives.",2022,"Compared with the placebo, the combination broadly neutralizing monoclonal antibodies maintained complete suppression of plasma viraemia (for up to 43 weeks) after analytical treatment interruption, provided that no antibody-resistant HIV was detected at the baseline in the study participants.","['enrolled individuals with viraemic control who were naive to antiretroviral therapy', 'enrolled participants who initiated antiretroviral therapy during the acute/early phase of HIV infection']","['Antiretroviral therapy', 'placebo', '3BNC117']","['potent HIV suppression', 'plasma viraemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}]",,0.514647,"Compared with the placebo, the combination broadly neutralizing monoclonal antibodies maintained complete suppression of plasma viraemia (for up to 43 weeks) after analytical treatment interruption, provided that no antibody-resistant HIV was detected at the baseline in the study participants.","[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Sneller', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Blazkova', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'J Shawn', 'Initials': 'JS', 'LastName': 'Justement', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Brooke D', 'Initials': 'BD', 'LastName': 'Kennedy', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Gittens', 'Affiliation': 'Critical Care Medicine Department, Clinical Center, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jekaterina', 'Initials': 'J', 'LastName': 'Tolstenko', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'McCormack', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Whitehead', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Schneck', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Proschan', 'Affiliation': 'Biostatistics Research Branch, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Benko', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Kovacs', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Oguz', 'Affiliation': 'NIAID Collaborative Bioinformatics Resource, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Caskey', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Michel C', 'Initials': 'MC', 'LastName': 'Nussenzweig', 'Affiliation': 'Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Fauci', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Moir', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Tae-Wook', 'Initials': 'TW', 'LastName': 'Chun', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA. twchun@nih.gov.'}]",Nature,['10.1038/s41586-022-04797-9']
1345,35653174,Indicated Web-Based Prevention for Women With Anorexia Nervosa Symptoms: Randomized Controlled Efficacy Trial.,"BACKGROUND


Although preventive interventions for eating disorders in general have shown promise, interventions specifically targeting individuals at risk for anorexia nervosa (AN) are lacking.
OBJECTIVE


The aim of this study was to determine the efficacy of a guided, indicated web-based prevention program for women at risk for AN.
METHODS


We conducted a randomized controlled efficacy trial for women at risk for AN. Assessments were carried out at baseline (before the intervention), after the intervention (10 weeks after baseline), and at 6- and 12-month follow-ups (FUs). A total of 168 women with low body weight (17.5 kg/m 2 ≤BMI≤19 kg/m 2 ) and high weight concerns or with normal body weight (19 kg/m 2 <BMI≤25 kg/m 2 ), high weight concerns, and high restrained eating were recruited from 3 German universities as well as on the web and randomized to Student Bodies-AN (SB-AN; intervention group [IG]) or a wait-list control group (CG). The exclusion criteria were current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-based full-syndrome eating disorders and serious medical or mental problems. The interventions were a cognitive-behavioral guided web-based prevention program (SB-AN) over 10 weeks (IG) and a wait-list CG. The primary outcomes were clinically significant changes in disordered eating attitudes and behaviors and change in BMI at 12-month FU in the group of participants who were underweight. The secondary outcomes were new onset of eating disorders, symptoms of disordered eating, and associated psychopathology.
RESULTS


Data were available for 81.5% (137/168) of the women after the intervention and for 69% (116/168) of the women at 12-month FU. At 12-month FU, the IG participants showed larger decreases in Eating Disorder Examination total scores (38/48, 79% vs 33/58, 57%) than the CG participants and the IG participants who were underweight also showed larger clinically relevant increases in BMI (15/31, 49% vs 10/32, 32%) than the CG participants, but these differences were not significant. In addition, after the intervention and at 12-month FU, we found a significant increase in continuously measured BMI for the participants who were underweight and significant improvements in disordered eating attitudes and behaviors (eg, restrained eating as well as weight and shape concerns). At all time points, the rates of new-onset eating disorder cases were (nonsignificantly) lower in the IG than in the CG and the reductions in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition-based eating disorder syndromes were (nonsignificantly) higher in the IG than in the CG.
CONCLUSIONS


SB-AN is the first preventive intervention shown to significantly reduce specific risk factors for, and symptoms of, AN and shows promise for reducing full-syndrome AN onset.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN70380261; https://www.isrctn.com/ISRCTN70380261.",2022,"At 12-month FU, the IG participants showed larger decreases in Eating Disorder Examination total scores (38/48, 79% vs 33/58, 57%) than the CG participants and the IG participants who were underweight also showed larger clinically relevant increases in BMI (15/31, 49% vs 10/32, 32%) than the CG participants, but these differences were not significant.","['women at risk for AN', '168 women with low body weight (17.5 kg/m 2 ≤BMI≤19 kg/m 2 ) and high weight concerns or with normal body weight', 'Women With Anorexia Nervosa Symptoms']","['guided, indicated web-based prevention program', 'cognitive-behavioral guided web-based prevention program (SB-AN', 'Student Bodies-AN (SB-AN; intervention group [IG]) or a wait-list control group (CG']","['new onset of eating disorders, symptoms of disordered eating, and associated psychopathology', 'BMI', 'disordered eating attitudes and behaviors and change in BMI', 'Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition-based eating disorder syndromes', 'rates of new-onset eating disorder cases', 'disordered eating attitudes and behaviors (eg, restrained eating as well as weight and shape concerns', 'Eating Disorder Examination total scores', 'continuously measured BMI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",168.0,0.0852074,"At 12-month FU, the IG participants showed larger decreases in Eating Disorder Examination total scores (38/48, 79% vs 33/58, 57%) than the CG participants and the IG participants who were underweight also showed larger clinically relevant increases in BMI (15/31, 49% vs 10/32, 32%) than the CG participants, but these differences were not significant.","[{'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Jacobi', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Faculty of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Vollert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Faculty of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Hütter', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Faculty of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'von Bloh', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Faculty of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Eiterich', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Faculty of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Görlich', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfälische Wilhelms-Universität Münster, Münster, Germany.'}, {'ForeName': 'C Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry, Stanford University School of Medicine, Stanford, CA, United States.'}]",Journal of medical Internet research,['10.2196/35947']
1346,35653788,Does trans fatty acid affect low birth weight? A randomised controlled trial.,"To evaluate the effect of low trans fatty acids (TFAs) dietary patterns during pregnancy on the risk of low birth weight (LBW). All pregnant women who received prenatal care with gestational age <8 weeks in this study took place in Tehran from December 2014 to August 2016. Women in the intervention group received dietary patterns with TFAs content of < 1%; those in the control group had dietary intake without any change in TFAs content. Dietary intakes were assessed by 3 non-consecutive 24-hour recalls in three trimesters. Hazard ratio (HR) was calculated using Cox proportional-hazards models. Incidence and HR (95% CI) for LBW based on multivariable adjusted models were calculated. Of the 800 women ( n  = 407 in control and  n  = 393 in intervention groups), 108 (13.5%) women were diagnosed with LBW. The incidence of LBW in the intervention group was 12% and in the control group was 19%. After multivariable adjustment for confounders, the HR for incident LBW in the intervention group was 0.65 (0.44-0.96). Kaplan-Meier plot showed a significant difference between the two groups in the incidence of LBW. Intake of low TFAs dietary patterns during pregnancy reduced the risk of LBW. IMPACT STATEMENT What is already known on this subject?  Maternal nutrition affects foetal development, and one important dietary determinant of foetal growth may be trans fatty acids (TFAs). It is generally advised to avoid high-fat dairy products that are the main sources of TFAs during pregnancy; however, there is limited data on the effects of a diet of LBW. What do the results of this study add?  Intake of low TFAs dietary patterns during pregnancy reduced the risk of LBW. In this study, the risk of LBW in the intervention group decreased by about 50%. What are the implications of these findings for clinical practice and/or further research?  The results of this study could give physicians and other health care providers the hint that Management of maternal nutrition with focussed on TFAs content should be included in routine prenatal care, to facilitate interventions and guidance regarding maternal nutrition.",2022,Kaplan-Meier plot showed a significant difference between the two groups in the incidence of LBW.,"['800 women ( n \u2009=\u2009407 in control and  n \u2009=\u2009393 in intervention groups), 108 (13.5%) women were diagnosed with LBW', 'All pregnant women who received prenatal care with gestational age <8\u2009weeks in this study took place in Tehran from December 2014 to August 2016']","['dietary patterns with TFAs', 'low trans fatty acids (TFAs) dietary patterns', 'IMPACT']","['risk of LBW', 'Dietary intakes', 'Hazard ratio (HR', 'risk of low birth weight (LBW', 'incidence of LBW', 'Incidence and HR']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0304772,Kaplan-Meier plot showed a significant difference between the two groups in the incidence of LBW.,"[{'ForeName': 'Seideh Hanieh', 'Initials': 'SH', 'LastName': 'Alamolhoda', 'Affiliation': 'Midwifery and Reproductive Health Research Center, Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Golaleh', 'Initials': 'G', 'LastName': 'Asghari', 'Affiliation': 'Nutritional Sciences Department of Clinical Nutrition, School of Nutrition Sciences & Food Technology, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Mirabi', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Mazandaran, Iran.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2022.2080532']
1347,35654226,Continuous versus routine EEG in patients after cardiac arrest: Analysis of a randomized controlled trial (CERTA).,"BACKGROUND


Electroencephalography (EEG) is essential to assess prognosis in patients after cardiac arrest (CA). Use of continuous EEG (cEEG) is increasing in critically-ill patients, but it is more resource-consuming than routine EEG (rEEG). Observational studies did not show a major impact of cEEG versus rEEG on outcome, but randomized studies are lacking.
METHODS


We analyzed data of the CERTA trial (NCT03129438), including comatose adults after CA undergoing cEEG (30-48 hours) or two rEEG (20-30 minutes each). We explored correlations between recording EEG type and mortality (primary outcome), or Cerebral Performance Categories (CPC, secondary outcome), assessed blindly at 6 months, using uni- and multivariable analyses (adjusting for other prognostic variables showing some imbalance across groups).
RESULTS


We analyzed 112 adults (52 underwent rEEG, 60 cEEG,); 31 (27.7%) were women; 68 (60.7%) patients died. In univariate analysis, mortality (rEEG 59%, cEEG 65%, p = 0.318) and good outcome (CPC 1-2; rEEG 33%, cEEG 27%, p = 0.247) were comparable across EEG groups. This did not change after multiple logistic regressions, adjusting for shockable rhythm, time to return of spontaneous circulation, serum neuron-specific enolase, EEG background reactivity, regarding mortality (cEEG vs rEEG: OR 1.60, 95% CI 0.43-5.83, p = 0.477), and good outcome (OR 0.51, 95% CI 0.14-1.90, p = 0.318).
CONCLUSION


This analysis suggests that cEEG or repeated rEEG are related to comparable outcomes of comatose patients after CA. Pending a prospective, large randomized trial, this finding does not support the routine use of cEEG for prognostication in this setting.
TRIAL REGISTRATION


Continuous EEG Randomized Trial in Adults (CERTA); NCT03129438; July 25, 2019.",2022,"In univariate analysis, mortality (rEEG 59%, cEEG 65%, p=0.318) and good outcome (CPC 1-2; rEEG 33%, cEEG 27%, p=0.247) were comparable across EEG groups.","['patients after cardiac arrest (CA', 'comatose patients after CA', 'patients after cardiac arrest-Analysis', 'Adults (CERTA); NCT03129438; July 25, 2019', 'comatose adults after CA undergoing cEEG (30-48 hours) or two rEEG (20-30 minutes each', 'critically-ill patients', '112 adults (52 underwent rEEG, 60 cEEG,); 31 (27.7%) were women; 68 (60.7%) patients died']","['cEEG versus rEEG', 'continuous EEG (cEEG', 'Electroencephalography (EEG', 'Continuous versus routine EEG']","['shockable rhythm, time to return of spontaneous circulation, serum neuron-specific enolase, EEG background reactivity, regarding mortality', 'recording EEG type and mortality (primary outcome), or Cerebral Performance Categories (CPC, secondary outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1306577', 'cui_str': 'O/E - dead'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.16253,"In univariate analysis, mortality (rEEG 59%, cEEG 65%, p=0.318) and good outcome (CPC 1-2; rEEG 33%, cEEG 27%, p=0.247) were comparable across EEG groups.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Urbano', 'Affiliation': 'Department of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Alvarez', 'Affiliation': 'Department of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland; Department of Neurology, Hôpital du Valais, Sion, Switzerland.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Schindler', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rüegg', 'Affiliation': 'Department of Neurology, University Hospital Basel, and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nawfel', 'Initials': 'N', 'LastName': 'Ben-Hamouda', 'Affiliation': 'Department of Adult Intensive Care Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Novy', 'Affiliation': 'Department of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Andrea O', 'Initials': 'AO', 'LastName': 'Rossetti', 'Affiliation': 'Department of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland. Electronic address: andrea.rossetti@chuv.ch.'}]",Resuscitation,['10.1016/j.resuscitation.2022.05.017']
1348,35654120,The effect of coupled inhibitory-facilitatory repetitive transcranial magnetic stimulation on shaping early reorganization of the motor network after stroke.,"Neural plasticity is a major factor driving cortical reorganization after stroke. This study aimed to evaluate functional connectivity (FC) changes in the cortical motor network after coupled inhibitory-facilitatory repetitive transcranial magnetic stimulation (rTMS) treatment and to assess the correlation between FC changes and functional recovery, further characterizing the neural mechanisms underlying the beneficial effects of rTMS. We randomly divided 63 patients with acute stroke into four groups: (1) Group A received coupled inhibitory-facilitatory rTMS [1 Hz over the contralesional primary motor cortex (M1) and 10 Hz over ipsilesional M1]; (2) Group B received a contralesional sham stimulation and ipsilesional 10 Hz stimulation; (3) Group C received a contralesional 1 Hz rTMS and ipsilesional sham stimulation; and (4) Group D received bilateral sham stimulation only. Standardized rehabilitation therapy was performed immediately after rTMS, and each group was treated with their respective treatment modalities for 4 weeks. Twenty-four hours before and after the intervention, participants underwent resting-state functional magnetic resonance imaging. Additional functional assessments were conducted at baseline, after treatment, and at the 3 month follow-up. The rTMS treatment significantly changed the FCs of intra- and inter-hemispheric cortical motor networks in the rTMS groups (A and B) compared with the sham group (Group D). This effect was more pronounced in Group A, which displayed a changed FC between the contralesional postcentral gyrus and contralesional superior parietal gyrus, between the contralesional precentral gyrus and contralesional postcentral gyrus, and between the ipsilesional postcentral gyrus and contralesional superior parietal gyrus, when compared with Groups B and C. Importantly, FC changes were significantly correlated with improvement of motor function. In the early stages of ischemic stroke, coupled rTMS was more conducive to motor recovery by modulating the FCs of intra-hemispheric and inter-hemispheric motor networks. Our results suggested that FC changes were related to motor function recovery for early-stage cerebral stroke patients treated with coupled rTMS. These findings could help to understand the mechanism of coupled rTMS and further the use of this therapy as an adjunct rehabilitation technique in motor recovery.",2022,The rTMS treatment significantly changed the FCs of intra- and inter-hemispheric cortical motor networks in the rTMS groups (A and B) compared with the sham group (Group D).,['63 patients with acute stroke into four groups: (1) Group A received'],"['coupled inhibitory-facilitatory rTMS [1 Hz over the contralesional primary motor cortex (M1) and 10 Hz over ipsilesional M1]; (2) Group B received a contralesional sham stimulation and ipsilesional 10 Hz stimulation; (3) Group C received a contralesional 1 Hz rTMS and ipsilesional sham stimulation; and (4) Group D received bilateral sham stimulation only', 'rTMS', 'resting-state functional magnetic resonance imaging', 'Standardized rehabilitation therapy', 'coupled inhibitory-facilitatory repetitive transcranial magnetic stimulation', 'inhibitory-facilitatory repetitive transcranial magnetic stimulation (rTMS']","['FCs of intra- and inter-hemispheric cortical motor networks', 'motor function recovery', 'motor function', 'FC changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",63.0,0.0139036,The rTMS treatment significantly changed the FCs of intra- and inter-hemispheric cortical motor networks in the rTMS groups (A and B) compared with the sham group (Group D).,"[{'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine &Rehabilitation, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China; Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Haiwei', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Emergency Medicine, The Second Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Physical Medicine &Rehabilitation, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China.'}, {'ForeName': 'Chuandao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Medicine &Rehabilitation, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China.'}, {'ForeName': 'Liqiang', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China.'}, {'ForeName': 'Xiuying', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine &Rehabilitation, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China. Electronic address: lilisuda@126.com.'}, {'ForeName': 'Lichi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai 200030, China. Electronic address: lichizhang@sjtu.edu.cn.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, China. Electronic address: fangqi@suda.edu.cn.'}]",Brain research,['10.1016/j.brainres.2022.147959']
1349,35655280,Surgical versus non-surgical treatment of humeral SHAFT fractures compared by a patient-reported outcome: the Scandinavian Humeral diAphyseal Fracture Trial (SHAFT)-a study protocol for a pragmatic randomized controlled trial.,"BACKGROUND


The outcome of non-surgical treatment is generally good, but the treatment course can be long and painful with approximately a quarter of the patients acquiring a nonunion. Both surgical and non-surgical treatment can have disabling consequences such as nerve injury, infection, and nonunion. The purpose of the study is to compare patient-reported outcomes after surgical and non-surgical treatment for humeral shaft fractures.
METHODS


A pragmatic randomized controlled trial (RCT) is planned with two study groups (SHAFT-Young and SHAFT-Elderly). A total of 287 eligible acute humeral shaft fractures are scheduled to be recruited and randomly allocated to surgical or non-surgical treatment with the option of early crossover due to delayed union. The surgical method within the allocation is decided by the surgeon. The primary outcome is the Disability of Arm, Shoulder, and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score, EQ-5D-5L, pain assessed by visual analog score, Constant-Murley score including elbow range of motion, and anchor questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening, and peri-implant fracture), major adverse cardiovascular events, and mortality.
DISCUSSION


The SHAFT trial is a pragmatic multicenter RCT, that will compare the effectiveness of the main strategies in humeral shaft fracture treatment. This will include a variety of fracture morphologies, while taking the dilemmas within the population into account by splitting the population by age and providing the orthopedic society with an interval for early crossover surgery.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04574336 . Registered on 5 October 2020.",2022,"The primary outcome is the Disability of Arm, Shoulder, and Hand (DASH) score at 52 weeks, and is assessor blinded.","['humeral shaft fractures', '287 eligible acute humeral shaft fractures', 'groups (SHAFT-Young and SHAFT-Elderly']","['surgical or non-surgical treatment with the option of early crossover due to delayed union', 'surgical and non-surgical treatment', 'Surgical versus non-surgical treatment of humeral SHAFT fractures']","['infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening, and peri-implant fracture), major adverse cardiovascular events, and mortality', 'DASH score, EQ-5D-5L, pain assessed by visual analog score, Constant-Murley score including elbow range of motion, and anchor questions', 'Disability of Arm, Shoulder, and Hand (DASH) score']","[{'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0337141', 'cui_str': 'Shaft'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0178324', 'cui_str': 'Injury of blood vessel'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C2717972', 'cui_str': 'Peri-Implant Fractures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0575649', 'cui_str': 'Elbow joint - range of movement'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}]",287.0,0.259217,"The primary outcome is the Disability of Arm, Shoulder, and Hand (DASH) score at 52 weeks, and is assessor blinded.","[{'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Karimi', 'Affiliation': 'Department of Orthopedic Surgery, Kolding Hospital, Kolding, Denmark. dennis.karimi@rsyd.dk.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Brorson', 'Affiliation': 'Department of Orthopedic Surgery, Centre for Evidence-Based Orthopaedics, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Kaare S', 'Initials': 'KS', 'LastName': 'Midtgaard', 'Affiliation': 'Department of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Fjalestad', 'Affiliation': 'Department of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Aksel', 'Initials': 'A', 'LastName': 'Paulsen', 'Affiliation': 'Department of Orthopedic Surgery, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Olerud', 'Affiliation': 'Department of Orthopedic Surgery, Stockholm South General Hospital, Stockholm, Sweden.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Ekholm', 'Affiliation': 'Department of Orthopedic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Wolf', 'Affiliation': 'Department of Surgical Sciences, Section of Orthopedics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Bjarke', 'Initials': 'B', 'LastName': 'Viberg', 'Affiliation': 'Department of Orthopedic Surgery, Kolding Hospital, Kolding, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-022-06317-6']
1350,35657133,Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial.,"The PRIORITIZE trial (clinicaltrials.gov: NCT02786537) was the first comparative effectiveness study to directly compare ledipasvir/sofosbuvir (LDV/SOF) and elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic hepatitis C virus (HCV). A secondary aim of this study was to compare LDV/SOF and EBR/GZR on sustainable changes in several HCV-associated symptoms and functional well-being in patients who achieved sustained virological response (SVR). PRIORITIZE, a randomized controlled trial conducted between 2016 and 2020, evaluated change in six PROMIS® symptom scores (fatigue, sleep disturbance, cognitive disturbance, nausea, diarrhoea, abdominal pain) and functional well-being using the disease-specific HCV-PRO instrument. Survey assessments were administered at baseline, early post-treatment (median = 6 months) and late post-treatment (median = 21 months). Constrained longitudinal linear mixed-effects models were used to evaluate within-treatment change and between-treatment differences. Data from 793 participants (average 55 years old, 57% male, 44% black, 17% with cirrhosis) were analysed. From baseline to early post-treatment, 5 out of 6 symptoms and functional well-being significantly improved (all p's < .05). In the LDV/SOF arm, mean changes ranged from -3.73 for nausea to -6.41 for fatigue and in the EBR/GZR, mean changes ranged from -2.19 for cognitive impairment to -4.67 for fatigue. Change of >3 points was consider clinically meaningful. Improvements in most symptoms slightly favoured LDV/SOF, although the magnitude of differences between the regimens were small. Both regimens demonstrated significant improvements in symptoms and functional well-being that were sustained during the late post-treatment phase. EBR/GZR and LDV/SOF regimens had clinically equivalent and durable improvements in HCV symptoms and functional well-being up to two years after SVR.",2022,EBR/GZR and LDV/SOF regimens had clinically equivalent and durable improvements in HCV symptoms and functional well-being up to two years after SVR.,"['patients who achieved sustained virological response (SVR', '793 participants (average 55\u2009years old, 57% male, 44% black, 17% with cirrhosis', 'chronic hepatitis C virus (HCV']","['ledipasvir/sofosbuvir (LDV/SOF) and elbasvir/grazoprevir (EBR/GZR', 'Ledipasvir/Sofosbuvir versus Elbasvir/Grazoprevir']","['nausea', 'six PROMIS® symptom scores (fatigue, sleep disturbance, cognitive disturbance, nausea, diarrhea, abdominal pain) and functional well-being using the disease-specific HCV-PRO instrument', 'HCV symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}]","[{'cui': 'C3858051', 'cui_str': 'sofosbuvir and ledipasvir'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.11319,EBR/GZR and LDV/SOF regimens had clinically equivalent and durable improvements in HCV symptoms and functional well-being up to two years after SVR.,"[{'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Evon', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Meichen', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Bryce B', 'Initials': 'BB', 'LastName': 'Reeve', 'Affiliation': 'Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Peter', 'Affiliation': 'Division of Gastroenterology, Hepatology & Nutrition, Department of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Michael', 'Affiliation': 'Center for Gastroenterology Biology and Disease, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Lok', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Nelson', 'Affiliation': 'Division of Gastroenterology, Hepatology & Nutrition, Department of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Stewart', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina, USA.'}]",Journal of viral hepatitis,['10.1111/jvh.13716']
1351,35659521,Enhanced parasympathetic cholinergic activity with galantamine inhibited lipid-induced oxidative stress in obese African Americans.,"BACKGROUND


African Americans (AAs) are disproportionately affected by cardiovascular disease (CVD), they are 20% more likely to die from CVD than whites, chronic exposure to inflammation and oxidative stress contributes to CVD. In previous studies, enhancing parasympathetic cholinergic activity has been shown to decrease inflammation. Considering that AAs have decreased parasympathetic activity compared to whites, we hypothesize that stimulating it with a central acetylcholinesterase (AChE) inhibitor, galantamine, would prevent lipid-induced oxidative stress.
OBJECTIVE


To test the hypothesis that acute dose of galantamine, an AChE inhibitor, decreases lipid-induced oxidative stress in obese AAs.
METHODS


Proof-of-concept, double-blind, randomized, placebo-controlled, crossover study that tested the effect of a single dose of 16 mg of galantamine versus placebo on lipid-induced oxidative stress in obese AAs. Subjects were studied on two separate days, one week apart. In each study day, 16 mg or matching placebo was administered before 20% intralipids infusion at doses of 0.8 mL/m2/min with heparin at doses of 200 U/h for 4 h. Outcomes were assessed at baseline, 2 and 4 h during the infusion.
MAIN OUTCOME MEASURES


Changes in F 2 -isoprostane (F 2 -IsoPs), marker of oxidative stress, measured in peripheral blood mononuclear cells (PBMC) and in plasma at baseline, 2, and 4-h post-lipid infusion. Secondary outcomes include changes in inflammatory cytokines (IL-6, TNF alpha).
RESULTS


A total of 32 obese AA women were screened and fourteen completed the study (age 37.8 ± 10.70 years old, BMI 38.7 ± 3.40 kg/m 2 ). Compared to placebo, 16 mg of galantamine significantly inhibited the increase in F 2 -IsoPs in PBMC (0.007 ± 0.008 vs. - 0.002 ± 0.006 ng/sample, P = 0.016), and plasma (0.01 ± 0.02 vs. - 0.003 ± 0.01 ng/mL, P = 0.023). Galantamine also decreased IL-6 (11.4 ± 18.45 vs. 7.7 ± 15.10 pg/mL, P = 0.021) and TNFα levels (18.6 ± 16.33 vs. 12.9 ± 6.16 pg/mL, P = 0.021, 4-h post lipid infusion) compared with placebo. These changes were associated with an increased plasma acetylcholine levels induced by galantamine (50.5 ± 10.49 vs. 43.6 ± 13.38 during placebo pg/uL, P = 0.025).
CONCLUSIONS


In this pilot, proof-of-concept study, enhancing parasympathetic nervous system (PNS) cholinergic activity with galantamine inhibited lipid-induced oxidative stress and inflammation induced by lipid infusion in obese AAs.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers NCT02365285.",2022,Galantamine also decreased IL-6,"['32 obese AA women were screened and fourteen completed the study (age 37.8\u2009±\u200910.70\xa0years old, BMI 38.7\u2009±\u20093.40\xa0kg/m 2 ', 'African Americans (AAs', 'obese AAs', 'obese African Americans']","['heparin', 'galantamine', 'Galantamine', 'matching placebo', 'galantamine versus placebo', 'placebo']","['changes in inflammatory cytokines (IL-6, TNF alpha', 'parasympathetic activity', 'lipid-induced oxidative stress', 'IL-6', 'Changes in F 2 -isoprostane (F 2 -IsoPs), marker of oxidative stress, measured in peripheral blood mononuclear cells (PBMC) and in plasma at baseline, 2, and 4-h post-lipid infusion', 'TNFα levels', 'oxidative stress', 'F 2 -IsoPs in PBMC', 'plasma acetylcholine levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0949860', 'cui_str': 'Isoprostane'}, {'cui': 'C0997851', 'cui_str': 'Geodia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}]",,0.422313,Galantamine also decreased IL-6,"[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Parsa', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232, USA.'}, {'ForeName': 'Luul A', 'Initials': 'LA', 'LastName': 'Aden', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Pitzer', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232, USA.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Ding', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Diedrich', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232, USA.'}, {'ForeName': 'Ginger L', 'Initials': 'GL', 'LastName': 'Milne', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232, USA.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Kirabo', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232, USA.'}, {'ForeName': 'Cyndya A', 'Initials': 'CA', 'LastName': 'Shibao', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Vanderbilt University Medical Center, 506 Robinson Research Building, Nashville, TN, 37232, USA. cyndya.shibao@vumc.org.'}]","Molecular medicine (Cambridge, Mass.)",['10.1186/s10020-022-00486-5']
1352,35660486,The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use.,"BACKGROUND


Total joint arthroplasties are common orthopedic surgeries that carry risk for developing chronic post-surgical pain. In addition to pre- and post-operative pain severity, psychological distress (e.g., anxiety, pain catastrophizing) is a risk factor for chronic postsurgical pain. Cognitive behavioral therapy (CBT) for chronic pain is an empirically supported approach to managing chronic pain, functional impairment, and related distress. While CBT has been used extensively in patients with established chronic pain, using it as a preventive intervention targeting the transition from acute to chronic postsurgical pain is a novel application.
OBJECTIVES


The Perioperative Pain Self-Management (PePS) program is a pain self-management intervention based on the principles of CBT. This innovative intervention is brief, flexible, and is delivered remotely. The current study aims to determine the efficacy of PePS compared to standard care on reducing the incidence of significant surgical site pain at 6-months post-surgery. The current study also aims to evaluate the context for subsequent implementation.
METHODS


This study is a hybrid type I efficacy-preparing for implementation trial. It is a two-site, single-blind, two-arm, parallel, randomized control trial. Surgical patients will be randomized to either receive: 1) PePS plus standard care, or 2) Standard care. The primary end point will be surgical site pain severity at 6-months post-surgery.
CONCLUSION


Results from this study are expected to result in support for a brief scalable intervention (PePS) that can prevent the development of chronic pain and prolonged post-surgical opioid use, as well as key details to inform subsequent implementation.
CLINICALTRIALS


govIdentifier:NCT04979429.",2022,The current study aims to determine the efficacy of PePS compared to standard care on reducing the incidence of significant surgical site pain at 6-months post-surgery.,"['Surgical patients', 'patients with established chronic pain']","['receive: 1) PePS plus standard care, or 2) Standard care', 'PePS', 'Cognitive behavioral therapy (CBT', 'CBT']",['surgical site pain severity'],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0779772,The current study aims to determine the efficacy of PePS compared to standard care on reducing the incidence of significant surgical site pain at 6-months post-surgery.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hadlandsmyth', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA; University of Iowa, Carver College of Medicine, Department of Anesthesia, Iowa City, IA 52242, USA. Electronic address: katherine-hadlandsmyth@uiowa.edu.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Burgess', 'Affiliation': 'Center for Care Delivery and Outcomes Research (CCDOR), Minneapolis VA Healthcare System, Minneapolis, MN 55417, USA.'}, {'ForeName': 'Ryan F', 'Initials': 'RF', 'LastName': 'Leparski', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA.'}, {'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Odom', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Campbell', 'Affiliation': 'Center for Care Delivery and Outcomes Research (CCDOR), Minneapolis VA Healthcare System, Minneapolis, MN 55417, USA.'}, {'ForeName': 'Ashlie A', 'Initials': 'AA', 'LastName': 'Obrecht', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA; University of Iowa, Carver College of Medicine, Department of Anesthesia, Iowa City, IA 52242, USA.'}, {'ForeName': 'Jenna L', 'Initials': 'JL', 'LastName': 'Adamowicz', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA; University of Iowa, College of Liberal Arts and Sciences, Department of Psychological and Brain Sciences, Iowa City, IA 52242, USA.'}, {'ForeName': 'Hyunkeun', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'University of Iowa College of Public Health, Department of Biostatistics, Iowa City, IA 52242, USA.'}, {'ForeName': 'Kenda Stewart', 'Initials': 'KS', 'LastName': 'Steffensmeier', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Johnson', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Richards', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA; University of Iowa, College of Liberal Arts and Sciences, Department of Psychological and Brain Sciences, Iowa City, IA 52242, USA; University of Iowa College of Public Health, Department of Community and Behavioral Health, Iowa City, IA 52242, USA; University of Iowa, Carver College of Medicine, Department of Internal Medicine, Iowa City, IA 52242, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Lund', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA; University of Iowa College of Public Health, Department of Epidemiology, Iowa City, IA 52242, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Yoon', 'Affiliation': 'Center for Care Delivery and Outcomes Research (CCDOR), Minneapolis VA Healthcare System, Minneapolis, MN 55417, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Mosher', 'Affiliation': 'Center for Access & Delivery Research and Evaluation (CADRE), Iowa City VA Health Care System, Iowa City, IA 52246, USA; University of Iowa, Carver College of Medicine, Department of Internal Medicine, Iowa City, IA 52242, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106810']
1353,35660485,Rationale and design of a randomized controlled clinical trial; Titration of oxygen levels (TOOL) during mechanical ventilation.,"BACKGROUND


Both hyperoxemia and hypoxemia are deleterious in critically ill patients. Targeted oxygenation is recommended to prevent both of these extremes, however this has not translated to the bedside. Hyperoxemia likely persists more than hypoxemia due to absence of immediate discernible adverse effects, cognitive biases and delay in prioritization of titration.
METHODS


We present the methodology for the Titration Of Oxygen Levels (TOOL) trial, an open label, randomized controlled trial of an algorithm-based FiO 2  titration with electronic medical record-based automated alerts. We hypothesize that the study intervention will achieve targeted oxygenation by curbing episodes of hyperoxemia while preventing hypoxemia. In the intervention arm, electronic alerts will be used to titrate FiO 2  if SpO 2  is ≥94% with FiO 2  levels ≥0.4 over 45 min. FiO 2  will be titrated per standard practice in the control arm. This study is being carried out with deferred consent. The sample size to determine efficacy is 316 subjects, randomized in a 1:1 ratio to the intervention vs. control arm. The primary outcome is proportion of time during mechanical ventilation spent with FiO 2  ≥ 0.4 and SpO 2  ≥ 94%. We will also assess proportion of time during mechanical ventilation spent with SpO 2  < 88%, duration of mechanical ventilation, length of ICU and hospital stay, hospital mortality, and adherence to electronic alerts as secondary outcomes.
CONCLUSION


This study is designed to evaluate the efficacy of a high fidelity, bioinformatics-based, electronic medical record derived electronic alert system to improve targeted oxygenation in mechanically ventilated patients by reducing excessive FiO 2  exposure.",2022,The primary outcome is proportion of time during mechanical ventilation spent with FiO 2  ≥ 0.4 and SpO 2  ≥ 94%.,"['mechanically ventilated patients by reducing excessive FiO 2  exposure', '316 subjects', 'critically ill patients']",['algorithm-based FiO 2  titration with electronic medical record-based automated alerts'],"['proportion of time during mechanical ventilation spent with FiO 2 \u202f≥\u202f0.4 and SpO 2 \u202f≥\u202f94', 'duration of mechanical ventilation, length of ICU and hospital stay, hospital mortality, and adherence to electronic alerts']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]",,0.180391,The primary outcome is proportion of time during mechanical ventilation spent with FiO 2  ≥ 0.4 and SpO 2  ≥ 94%.,"[{'ForeName': 'Sonal R', 'Initials': 'SR', 'LastName': 'Pannu', 'Affiliation': 'The Ohio State University, Division of Pulmonary, Critical Care & Sleep Medicine, Columbus, OH, United States. Electronic address: sonal.pannu@osumc.edu.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Haddad', 'Affiliation': 'The Ohio State University, Department of Internal Medicine, Columbus, OH, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Exline', 'Affiliation': 'The Ohio State University, Division of Pulmonary, Critical Care & Sleep Medicine, Columbus, OH, United States.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Christman', 'Affiliation': 'The Ohio State University, Division of Pulmonary, Critical Care & Sleep Medicine, Columbus, OH, United States.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Horowitz', 'Affiliation': 'The Ohio State University, Division of Pulmonary, Critical Care & Sleep Medicine, Columbus, OH, United States.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Peters', 'Affiliation': 'The Ohio State University, Department of Respiratory Therapy, Columbus, OH, United States.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Brock', 'Affiliation': 'The Ohio State University, Center for Biostatistics and Bioinformatics, Columbus, OH, United States.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Diaz', 'Affiliation': 'The Ohio State University, Division of Pulmonary, Critical Care & Sleep Medicine, Columbus, OH, United States.'}, {'ForeName': 'Elliott D', 'Initials': 'ED', 'LastName': 'Crouser', 'Affiliation': 'The Ohio State University, Division of Pulmonary, Critical Care & Sleep Medicine, Columbus, OH, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106811']
1354,35660843,Conservative or liberal oxygen therapy for mechanically ventilated adults with acute brain pathologies: A post-hoc subgroup analysis.,"PURPOSE


To compare the effect of conservative vs. liberal oxygen therapy in mechanically ventilated adults in the intensive care unit (ICU) with non-hypoxic ischemic encephalopathy (HIE) acute brain pathologies.
MATERIALS AND METHODS


Post-hoc analysis of data from 217 patients with non-HIE acute brain pathologies included in the ICU Randomized Trial Comparing Two Approaches to OXygen therapy (ICU-ROX).
RESULTS


Patients allocated to conservative oxygen spent less time with oxygen saturation ≥ 97% (50.5 [interquartile range (IQR), 18.5-119] vs. 82 h [IQR, 38-164], absolute difference, -31.5 h; 95%CI, -59.6 to -3.4). At 180 days, 38 of 110 conservative oxygen patients (34.5%) and 28 of 104 liberal oxygen patients (26.9%) had died (absolute difference, 7.6 percentage points; 95%CI, -4.7 to 19.9 percentage points; P = 0.23; interaction P = 0.02 for non-HIE acute brain pathologies vs. HIE; interaction P = 0.53 for non-HIE acute brain pathologies vs. non-neurological conditions).
CONCLUSIONS


In this post-hoc analysis, patients admitted to the ICU with non-HIE acute brain pathologies treated with conservative oxygen therapy did not have significantly lower mortality than those treated with liberal oxygen. A trial with adequate statistical power is needed to determine whether our day 180 mortality point estimate of treatment effect favoring liberal oxygen therapy indicates a true effect.",2022,"RESULTS


Patients allocated to conservative oxygen spent less time with oxygen saturation ≥ 97% (50.5 [interquartile range (IQR), 18.5-119] vs. 82 h [IQR, 38-164], absolute difference, -31.5 h; 95%CI, -59.6 to -3.4).","['mechanically ventilated adults with acute brain pathologies', '217 patients with non-HIE acute brain pathologies included in the ICU Randomized Trial', 'patients admitted to the ICU with non-HIE acute brain pathologies treated with', 'mechanically ventilated adults in the intensive care unit (ICU) with non-hypoxic ischemic encephalopathy (HIE) acute brain pathologies']","['conservative oxygen therapy', 'OXygen therapy (ICU-ROX', 'Conservative or liberal oxygen therapy', 'liberal oxygen therapy', 'conservative vs. liberal oxygen therapy']","['conservative oxygen spent less time with oxygen saturation ≥', 'died', 'mortality']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",217.0,0.123508,"RESULTS


Patients allocated to conservative oxygen spent less time with oxygen saturation ≥ 97% (50.5 [interquartile range (IQR), 18.5-119] vs. 82 h [IQR, 38-164], absolute difference, -31.5 h; 95%CI, -59.6 to -3.4).","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Intensive Care Unit, Wellington Hospital, Wellington, New Zealand; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia; University of Melbourne, Parkville, Victoria, Australia. Electronic address: paul.young@ccdhb.org.nz.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Hodgson', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia; University of Melbourne, Parkville, Victoria, Australia; Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia; Intensive Care Unit, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia; Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia; Intensive Care Unit, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia; University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'Critical Care Division and Trauma, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia; School of Public Health, Imperial College London, London, England, UK.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Freebairn', 'Affiliation': 'Intensive Care Unit, Hawkes Bay Hospital, Hastings, New Zealand.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'King', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Linke', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, New Lambton Heights, New South Wales, Australia; School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2022.154079']
1355,35666897,Promoting glycemic control in young children with type I diabetes: Results from a pilot intervention for parents.,"OBJECTIVE


Nutrition and physical activity are key components of daily diabetes care in young children with type I diabetes (T1D). Normative developmental behavioral challenges related to nutrition and physical activity complicate management of T1D. The current pilot study evaluated the feasibility, acceptability, and indications of behavior change of an intervention aimed at improving nutrition and physical activity in young children with T1D.
METHOD


Thirty-6 parents of young children (ages 2-5 years, M = 4.2) with T1D from 2 clinics in the Washington, DC area were randomized to receive the type One Training (TOTs) program or Usual Care (UC). Assessments included recruitment and completion rates, participant acceptability, and outcomes including glycemic variability via continuous glucose monitoring, nutritional intake via remote food photography, physical activity via accelerometers, and parental report on behavior and psychosocial functioning.
RESULTS


Despite recruitment challenges, the TOTs program was feasible to administer, with high program and assessment completion rates. Acceptability ratings were very high but differed by recruitment site. Participants randomized to TOTs had an increase in percent of time in target glycemic range and reduction in behavioral feeding problems between baseline and follow-up while those randomized to UC did not. Participants in UC demonstrated a decrease in in moderate to vigorous physical activity at follow-up.
CONCLUSIONS


The TOTs program demonstrated preliminary feasibility and acceptability. Future research will examine components of treatment for evidence of efficacy and target the intervention to those most likely to benefit. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,Participants randomized to TOTs had an increase in percent of time in target glycemic range and reduction in behavioral feeding problems between baseline and follow-up while those randomized to UC did not.,"['young children with T1D.\nMETHOD\n\n\nThirty-6 parents of young children (ages 2-5 years, M = 4.2) with T1D from 2 clinics in the Washington, DC area', 'young children with type I diabetes', 'young children with type I diabetes (T1D']","['type One Training (TOTs) program or Usual Care (UC', 'TOTs']","['moderate to vigorous physical activity', 'recruitment and completion rates, participant acceptability, and outcomes including glycemic variability via continuous glucose monitoring, nutritional intake via remote food photography, physical activity via accelerometers, and parental report on behavior and psychosocial functioning', 'Acceptability ratings', 'percent of time in target glycemic range and reduction in behavioral feeding problems']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",,0.0067786,Participants randomized to TOTs had an increase in percent of time in target glycemic range and reduction in behavioral feeding problems between baseline and follow-up while those randomized to UC did not.,"[{'ForeName': 'Eleanor R', 'Initials': 'ER', 'LastName': 'Mackey', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Tully', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Rose', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hamburger', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Herrera', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Cogen', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Monaghan', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hornack', 'Affiliation': 'Department of Psychology and Behavioral Health.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Streisand', 'Affiliation': 'Department of Psychology and Behavioral Health.'}]","Families, systems & health : the journal of collaborative family healthcare",['10.1037/fsh0000672']
1356,35667401,Short term outcomes with dual chamber versus single chamber pacing for atrioventricular block - A crossover trial.,"A total of 42 patients were studied for primary outcomes of quality of life and 6MWD between VVIR and DDD modes. At end of 2 months after device implantation, randomization was done and the device was programmed to VVIR or DDD modes. At the end of 2 months in this mode QOL and functional was assessed and the patient was switched to other mode. The same protocol was followed at the end of 2 months. We found no difference in functional capacity and quality of life between the two pacing modes. None of the patients developed pacemaker syndrome and there was no preference for any of the modes.",2022,We found no difference in functional capacity and quality of life between the two pacing modes.,['42 patients'],['Dual Chamber versus Single Chamber Pacing'],"['quality of life and 6MWD between VVIR and DDD modes', 'pacemaker syndrome', 'functional capacity and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011037', 'cui_str': 'DDD'}, {'cui': 'C0340929', 'cui_str': 'Cardiac pacemaker syndrome'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",42.0,0.123334,We found no difference in functional capacity and quality of life between the two pacing modes.,"[{'ForeName': 'Ragavendra', 'Initials': 'R', 'LastName': 'Chanthanamuthu', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Sakthivel', 'Initials': 'S', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Anantharaj', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ajith Ananthakrishna', 'Initials': 'AA', 'LastName': 'Pillai', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Satheesh', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Raja J', 'Initials': 'RJ', 'LastName': 'Selvaraj', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India. Electronic address: raja.selvaraj@jipmer.ac.in.'}]",Indian heart journal,['10.1016/j.ihj.2022.06.003']
1357,35667400,A comparative study of intravenous labetalol VS intravenous nitroglycerin in the treatment of hypertensive crises.,"Hypertensive crises is still a major public health problem, causing end organ damage like myocardial infarction, stroke, and renal failure. Labetalol and nitroglycerine are among the two most commonly used medicine to control the blood pressure, but there is no head to head comparison between these two medicines. This was a prospective randomized non-blinded study which included 50 patients of hypertensive crises, out which 25 patients received intravenous labetalol and 25 patients received intravenous nitroglycerine. We found that labetalol controlled the blood pressure more rapidly in comparison to nitroglycerine, without causing any extra side effect.",2022,"We found that labetalol controlled the blood pressure more rapidly in comparison to nitroglycerine, without causing any extra side effect.","['hypertensive crises', '50 patients of hypertensive crises, out which 25 patients received']","['intravenous nitroglycerine', 'intravenous labetalol', 'labetalol', 'Labetalol and nitroglycerine', 'labetalol VS intravenous Nitroglycerin']",['blood pressure'],"[{'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",50.0,0.0269122,"We found that labetalol controlled the blood pressure more rapidly in comparison to nitroglycerine, without causing any extra side effect.","[{'ForeName': 'Mohammad Azharuddin', 'Initials': 'MA', 'LastName': 'Malik', 'Affiliation': 'Department of Cardiology, JN Medical College, AMU, Aligarh, India.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medicine, JN Medical College, AMU, Aligarh, India.'}, {'ForeName': 'Mujahid', 'Initials': 'M', 'LastName': 'Beg', 'Affiliation': 'Department of Medicine, JN Medical College, AMU, Aligarh, India.'}, {'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medicine, JN Medical College, AMU, Aligarh, India. Electronic address: shebuansari@gmail.com.'}]",Indian heart journal,['10.1016/j.ihj.2022.06.001']
1358,35670029,Adapting Brief Behavioral Treatment for Insomnia for Former National Football League Players: A Pilot Study.,"OBJECTIVES


Insomnia is highly prevalent among persons with chronic pain. Although cognitive behavioral therapy for insomnia is recommended as first-line treatment for insomnia, it is underutilized. We tested the feasibility of a potentially scalable alternative - Brief Behavioral Therapy for Insomnia (BBTI) for former National Football League (NFL) players, a group with a high prevalence of chronic pain. We assessed changes in sleep, pain, and psychological health.
METHODS


Single-arm clinical trial of an adapted telephone-delivered BBTI intervention in 40 former NFL players with insomnia. We collected data on changes in sleep, pain, and psychological health outcomes.
RESULTS


Among former players (30% racial/ethnic minorities), BBTI was both acceptable and feasible. BBTI was associated with improvements in sleep disturbance (primary exploratory sleep outcome, mean T-score change -6.2, 95% CI: -7.6, -4.8), sleep-related impairment (mean T-score change -5.7, 95% CI: -7.9, -3.5) and insomnia severity (mean change -5.3, 95% CI: -6.8, -3.5) post-intervention. Improvements were maintained at 2-months. BBTI was also associated with improvements in pain interference and intensity, but not psychological health.
CONCLUSION


An adapted telephone-delivered BBTI is acceptable and feasible among retired players with a range of insomnia symptoms and shows promise for improving sleep and pain. These data support the need for future trials assessing BBTI's effect on both sleep and pain outcomes.",2022,"T-score change -6.2, 95% CI: -7.6, -4.8)","['Insomnia for Former National Football League Players', 'Insomnia (BBTI) for former National Football League (NFL) players, a group with a high prevalence of chronic pain', 'persons with chronic pain', '40 former NFL players with insomnia']","['adapted telephone-delivered BBTI intervention', 'cognitive behavioral therapy']","['sleep, pain, and psychological health', 'sleep disturbance', 'pain interference and intensity', 'sleep, pain, and psychological health outcomes', 'insomnia severity', ' sleep-related impairment (mean TT-score change']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.151184,"T-score change -6.2, 95% CI: -7.6, -4.8)","[{'ForeName': 'Lindsey J', 'Initials': 'LJ', 'LastName': 'Wanberg', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston.""}, {'ForeName': 'S Justin', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Rottapel', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston.""}, {'ForeName': 'Tayla', 'Initials': 'T', 'LastName': 'von Ash', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jones', 'Affiliation': 'John Hopkins Bloomberg School of Public Health, Baltimore.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Brar', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Rinad', 'Initials': 'R', 'LastName': 'Beidas', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rueschman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston.""}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesia, Brigham and Women's Hospital, Boston.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Buysse', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston.""}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Bertisch', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston.""}]",Behavioral sleep medicine,['10.1080/15402002.2022.2082429']
1359,35671089,Mobile Phone Ownership and Use Among Women Screening for Cervical Cancer in a Community-Based Setting in Western Kenya: Observational Study.,"BACKGROUND


Mobile phone ownership among women of reproductive age in western Kenya is not well described, and our understanding of its link with care-seeking behaviors is nascent. Understanding access to and use of mobile phones among this population as well as willingness to participate in mobile health interventions are important in improving and more effectively implementing mobile health strategies.
OBJECTIVE


This study aims to describe patterns of mobile phone ownership and use among women attending cervical cancer screening and to identify key considerations for the use of SMS text message-guided linkage to treatment strategies and other programmatic implications for cervical cancer screening in Kenya.
METHODS


This analysis was nested within a cluster randomized trial evaluating various strategies for human papillomavirus (HPV)-based cervical cancer screening and prevention in a rural area in western Kenya between February and November 2018. A total of 3299 women were surveyed at the time of screening and treatment. Questionnaires included items detailing demographics, health history, prior care-seeking behaviors, and patterns of mobile phone ownership and use. We used bivariate and multivariable log-binomial regression to analyze associations between independent variables and treatment uptake among women testing positive for high-risk HPV.
RESULTS


Rates of mobile phone ownership (2351/3299, 71.26%) and reported daily use (2441/3299, 73.99%) were high among women. Most women (1953/3277, 59.59%) were comfortable receiving their screening results via SMS text messages, although the most commonly preferred method of notification was via phone calls. Higher levels of education (risk ratio 1.23, 95% CI 1.02-1.50), missing work to attend screening (risk ratio 1.29, 95% CI 1.10-1.52), and previous cervical cancer screening (risk ratio 1.27, 95% CI 1.05-1.55) were significantly associated with a higher risk of attending treatment after testing high-risk HPV-positive, although the rates of overall treatment uptake remained low (278/551, 50.5%) among this population. Those who shared a mobile phone with their partner or spouse were less likely to attend treatment than those who owned a phone (adjusted risk ratio 0.69, 95% CI 0.46-1.05). Treatment uptake did not vary significantly according to the type of notification method, which were SMS text message, phone call, or home visit.
CONCLUSIONS


Although the rates of mobile phone ownership and use among women in western Kenya are high, we found that individual preferences for communication of messages about HPV results and treatment varied and that treatment rates were low across the entire cohort, with no difference by modality (SMS text message, phone call, or home visit). Therefore, although text-based results performed as well as phone calls and home visits, our findings highlight the need for more work to tailor communication about HPV results and support women as they navigate the follow-up process.",2022,"Treatment uptake did not vary significantly according to the type of notification method, which were SMS text message, phone call, or home visit.
","['women testing positive for high-risk HPV', 'human papillomavirus (HPV)-based cervical cancer screening and prevention in a rural area in western Kenya between February and November 2018', 'A total of 3299 women were surveyed at the time of screening and treatment', 'women of reproductive age in western Kenya', 'women attending cervical cancer screening', 'cervical cancer screening in Kenya', 'Women Screening for Cervical Cancer in a Community-Based Setting in Western Kenya']","['mobile phone ownership', 'Mobile Phone Ownership and Use']","['previous cervical cancer screening', 'Questionnaires included items detailing demographics, health history, prior care-seeking behaviors, and patterns of mobile phone ownership and use']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0455458', 'cui_str': 'PMH - past medical history'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",3299.0,0.0983332,"Treatment uptake did not vary significantly according to the type of notification method, which were SMS text message, phone call, or home visit.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Stocks', 'Affiliation': 'Center for Global Reproductive Health, Duke Global Health Institute, Durham, NC, United States.'}, {'ForeName': 'Saduma', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Huchko', 'Affiliation': 'Center for Global Reproductive Health, Duke Global Health Institute, Durham, NC, United States.'}]",JMIR public health and surveillance,['10.2196/28885']
1360,35671553,Effects of Very Low Nicotine Content Cigarette use on Cigarette Reinforcement among Smokers with Serious Mental Illness.,"BACKGROUND


Among people without psychiatric disorders who smoke, very low nicotine content (VLNC) cigarette use reduces cigarette reinforcement. Whether this is true of people with serious mental illness (SMI) who smoke is unknown. Using a hypothetical purchase task, we compared the effects of 6-week use of VLNC versus normal nicotine content (NNC) cigarettes on study cigarette and usual brand (UB) cigarette reinforcement among people with SMI who smoke.
METHODS


After a baseline period of UB cigarette use, participants with SMI (n = 58) were randomized to use NNC cigarettes (15.8 mg nicotine/g tobacco) or VLNC cigarettes (0.4 mg/g) for 6 weeks. At Week 6, they completed the CPT for both their assigned study cigarette and UB. The groups were compared on demand intensity (number of cigarettes purchased at no cost) and elasticity (rate of decline in demand as price increases) using extra sum-of-squares F-tests. The effects of treatment on demand indices while controlling for covariates were assessed using hierarchical regression.
RESULTS


At Week 6, intensity of demand for study cigarettes was lower and elasticity was higher for the VLNC group relative to the NNC group (p < 0.0001). Furthermore, intensity of demand for UB cigarettes was lower for participants in the VLNC group relative to participants in the NNC group (p < 0.01). When controlling for baseline cigarettes per day, intensity remained significantly different for study cigarettes and usual brand cigarettes at Week 6.
CONCLUSION


A nicotine reduction policy may reduce cigarette reinforcement in this vulnerable population.",2022,"Furthermore, intensity of demand for UB cigarettes was lower for participants in the VLNC group relative to participants in the NNC group (p < 0.01).","['people without psychiatric disorders who smoke, very low nicotine content (VLNC) cigarette use reduces cigarette reinforcement', 'participants with SMI (n\xa0=\xa058', 'people with serious mental illness (SMI', 'people with SMI who smoke', 'smokers with serious mental illness']","['VLNC versus normal nicotine content (NNC) cigarettes on study cigarette and usual brand (UB) cigarette reinforcement', 'NNC cigarettes (15.8\xa0mg nicotine/g tobacco) or VLNC cigarettes', 'low nicotine content cigarette']","['intensity of demand for study cigarettes', 'intensity of demand for UB cigarettes', 'cigarette reinforcement']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]",58.0,0.0428915,"Furthermore, intensity of demand for UB cigarettes was lower for participants in the VLNC group relative to participants in the NNC group (p < 0.01).","[{'ForeName': 'Teresa E', 'Initials': 'TE', 'LastName': 'DeAtley', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI 02912, USA. Electronic address: Teresa_DeAtley@alumni.brown.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Cassidy', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Morgan L', 'Initials': 'ML', 'LastName': 'Snell', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI 02912, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2022.107376']
1361,35672833,Keeping up with the guidelines: design changes to the STREAM stage 2 randomised controlled non-inferiority trial for rifampicin-resistant tuberculosis.,"Results from the STREAM stage 1 trial showed that a 9-month regimen for patients with rifampicin-resistant tuberculosis was non-inferior to the 20-month regimen recommended by the 2011 WHO treatment guidelines. Similar levels of severe adverse events were reported on both regimens suggesting the need for further research to optimise treatment. Stage 2 of STREAM evaluates two additional short-course regimens, both of which include bedaquiline. Throughout stage 2 of STREAM, new drug choices and a rapidly changing treatment landscape have necessitated changes to the trial's design to ensure it remains ethical and relevant. This paper describes changes to the trial design to ensure that stage 2 continues to answer important questions. These changes include the early closure to recruitment of two trial arms and an adjustment to the definition of the primary endpoint. If the STREAM experimental regimens are shown to be non-inferior or superior to the stage 1 study regimen, this would represent an important contribution to evidence about potentially more tolerable and more efficacious MDR-TB regimens, and a welcome advance for patients with rifampicin-resistant tuberculosis and tuberculosis control programmes globally.Trial registration: ISRCTN ISRCTN18148631 . Registered 10 February 2016.",2022,Similar levels of severe adverse events were reported on both regimens suggesting the need for further research to optimise treatment.,['patients with rifampicin-resistant tuberculosis and tuberculosis control programmes globally'],['rifampicin-resistant tuberculosis'],['severe adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532782', 'cui_str': 'Rifampicin resistant tuberculosis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1532782', 'cui_str': 'Rifampicin resistant tuberculosis'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",,0.361904,Similar levels of severe adverse events were reported on both regimens suggesting the need for further research to optimise treatment.,"[{'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Goodall', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn 2nd Floor, London, WC1V 6LJ, UK. r.goodall@ucl.ac.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sanders', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn 2nd Floor, London, WC1V 6LJ, UK.'}, {'ForeName': 'Gay', 'Initials': 'G', 'LastName': 'Bronson', 'Affiliation': 'Research Division, Vital Strategies, New York, USA.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Gurumurthy', 'Affiliation': 'Vital Strategies, Singapore, Singapore.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Torrea', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Meredith', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn 2nd Floor, London, WC1V 6LJ, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nunn', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn 2nd Floor, London, WC1V 6LJ, UK.'}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Rusen', 'Affiliation': 'Research Division, Vital Strategies, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-022-06397-4']
1362,35648041,Continuous induction with lenalidomide/dexamethasone versus autologous stem cell transplantation in newly diagnosed multiple myeloma: a case for response-adapted approach.,"Although upfront autologous stem cell transplantation (ASCT) generally improves progression-free survival (PFS) in newly diagnosed multiple myeloma (NDMM), the overall survival (OS) benefit and optimal timing of ASCT are not well established. Patients with early response may be able to safely continue induction and avoid ASCT without compromised outcomes. We report an extended follow-up analysis of a phase 2 trial that randomized transplant-eligible patients with NDMM who responded to induction (50/65 patients) to continued induction or ASCT; median follow-up was 8.0 years. Patients had similar 8-year PFS (55% vs. 43%), 8-year OS (83% vs. 72%), and rates of at least very good partial response (72% vs. 84%) whether continuing induction of lenalidomide and dexamethasone (Ld arm) or receiving ASCT (Ld + ASCT arm) ( p  = 0.5). Notably, over 50% of patients receiving continuous Ld had PFS of 5-10 years. These results suggest the need for prospective trials incorporating response-adapted therapeutic approaches to NDMM.STATEMENT OF PRIOR PRESENTATIONPresented in abstract form (interim analysis) at the 56th annual meeting of the American Society of Hematology (San Francisco, CA, 6 December 2014) and at the 57th annual meeting of the American Society of Hematology (Orlando, FL, 3 December 2015).",2022,"Patients had similar 8-year PFS (55% vs. 43%), 8-year OS (83% vs. 72%), and rates of at least very good partial response (72% vs. 84%) whether continuing induction of lenalidomide and dexamethasone (Ld arm) or receiving ASCT (Ld + ASCT arm) ( p  = 0.5).","['randomized transplant-eligible patients with NDMM who responded to induction (50/65 patients) to continued induction or ASCT; median follow-up was 8.0\u2009years', 'newly diagnosed multiple myeloma']","['lenalidomide/dexamethasone', 'dexamethasone', 'ASCT', 'upfront autologous stem cell transplantation (ASCT', 'autologous stem cell transplantation']","['8-year PFS', '8-year OS', 'overall survival (OS) benefit', 'progression-free survival (PFS']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0762491,"Patients had similar 8-year PFS (55% vs. 43%), 8-year OS (83% vs. 72%), and rates of at least very good partial response (72% vs. 84%) whether continuing induction of lenalidomide and dexamethasone (Ld arm) or receiving ASCT (Ld + ASCT arm) ( p  = 0.5).","[{'ForeName': 'Oscar B', 'Initials': 'OB', 'LastName': 'Lahoud', 'Affiliation': 'Adult Bone Marrow Transplant Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Landau', 'Affiliation': 'Adult Bone Marrow Transplant Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Devlin', 'Affiliation': 'Department of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nikoletta', 'Initials': 'N', 'LastName': 'Lendvai', 'Affiliation': 'Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weltz', 'Affiliation': 'Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Tumininu', 'Initials': 'T', 'LastName': 'Ayorinde', 'Affiliation': 'Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Chung', 'Affiliation': 'Adult Bone Marrow Transplant Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Lesokhin', 'Affiliation': 'Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Kewalramani', 'Affiliation': 'Department of Hematology/Oncology, Lahey Hospital & Medical Center, Burlington, MA, USA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Korde', 'Affiliation': 'Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sham', 'Initials': 'S', 'LastName': 'Mailankody', 'Affiliation': 'Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Landgren', 'Affiliation': 'Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Adult Bone Marrow Transplant Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Raymond L', 'Initials': 'RL', 'LastName': 'Comenzo', 'Affiliation': 'Hematology/Oncology Service, Department of Medicine, Pathology and Laboratory Medicine, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Hassoun', 'Affiliation': 'Myeloma Service, Division of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2022.2062347']
1363,35648446,Microneedling plus topical dutasteride solution for androgenetic alopecia: a randomized placebo-controlled study.,,2022,,['androgenetic alopecia'],"['Microneedling plus topical dutasteride solution', 'placebo']",[],"[{'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.237612,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sánchez-Meza', 'Affiliation': ""Department of Dermatology, Hospital Universitario 'Dr. José Eleuterio González', Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ocampo-Candiani', 'Affiliation': ""Department of Dermatology, Hospital Universitario 'Dr. José Eleuterio González', Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gómez-Flores', 'Affiliation': ""Department of Dermatology, Hospital Universitario 'Dr. José Eleuterio González', Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.""}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Herz-Ruelas', 'Affiliation': ""Department of Dermatology, Hospital Universitario 'Dr. José Eleuterio González', Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ocampo-Garza', 'Affiliation': ""Department of Dermatology, Hospital Universitario 'Dr. José Eleuterio González', Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.""}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Orizaga-Y-Quiroga', 'Affiliation': ""Department of Dermatology, Hospital Universitario 'Dr. José Eleuterio González', Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Martínez-Moreno', 'Affiliation': ""Department of Dermatology, Hospital Universitario 'Dr. José Eleuterio González', Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.""}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Ocampo-Garza', 'Affiliation': ""Department of Dermatology, Hospital Universitario 'Dr. José Eleuterio González', Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.""}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.18285']
1364,35649684,Explicit versus implicit lower extremity sensory retraining for post-stroke chronic sensory deficits: a randomized controlled trial.,"PURPOSE


Sensory impairment post-stroke limits rehabilitation of balance and gait. This study aims to compare the effect of explicit sensory retraining (ESR) versus implicit repeated exposure (IRE) to stimuli of the lower extremity, assessing their effects on sensation, balance, and gait in individuals with chronic post-stroke sensory impairment.
MATERIALS AND METHODS


A two-arm parallel double-blind multicenter randomized controlled trial was conducted in physical therapy outpatient clinics. Volunteers with chronic sensory impairment post-stroke participated in 10 sessions of 45 min ESR or IRE, according to a detailed protocol. Outcome measures assessed sensation, balance, mobility, and participation.
RESULTS


A total of 64 participants were recruited (ESR,  n  = 34; IRE,  n  = 30). The intention-to-treat pre-post analysis demonstrated clinically meaningful changes for both interventions (10-31% improvement for the various measures), with no between-group difference or time × group interaction. The effect size for the time effect varied, with the largest being 0.63 for the miniBEST.
CONCLUSIONS


Sensory rehabilitation treatment by either ESR or IRE led to similar clinically significant changes in the performance of the lower extremity and participation in subjects with sensory loss post-stroke. Both treatment protocols are easy to implement in an outpatient clinic.  .
CLINICALTRIALS.GOV REGISTRATION


NCT01988220. Implications for rehabilitationStandardized, structured, sensory-focused training can improve balance and gait in subjects with chronic post-stroke sensory impairment.Both explicit and implicit learning-based sensory protocols focused on the lower extremity effectively improved balance, mobility, and gait abilities, resulting in enhanced participation of individuals in the chronic post-stroke phase.A series of ten 45-minute treatment sessions in outpatient clinics lead to clinically significant improvements.",2022,"Both explicit and implicit learning-based sensory protocols focused on the lower extremity effectively improved balance, mobility, and gait abilities, resulting in enhanced participation of individuals in the chronic post-stroke phase.","['subjects with chronic post-stroke sensory impairment', 'Volunteers with chronic sensory impairment post-stroke participated in 10', 'A total of 64 participants were recruited (ESR,  n \u2009=\u200934; IRE,  n \u2009=\u200930', 'post-stroke chronic sensory deficits', 'physical therapy outpatient clinics', 'individuals with chronic post-stroke sensory impairment']","['Explicit versus implicit lower extremity sensory retraining', 'explicit sensory retraining (ESR) versus implicit repeated exposure (IRE', 'implicit learning-based sensory protocols', 'sessions of 45\u2009min ESR or IRE']","['sensation, balance, and gait', 'balance, mobility, and gait abilities', 'sensation, balance, mobility, and participation']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0556505', 'cui_str': 'Sensory retraining'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0748618', 'cui_str': 'Sensory deficit'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0556505', 'cui_str': 'Sensory retraining'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",64.0,0.102076,"Both explicit and implicit learning-based sensory protocols focused on the lower extremity effectively improved balance, mobility, and gait abilities, resulting in enhanced participation of individuals in the chronic post-stroke phase.","[{'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Ofek', 'Affiliation': 'Department of Physical Therapy, School of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Alperin', 'Affiliation': 'Clalit Health Services, Haifa and Western Galilee, Haifa, Israel.'}, {'ForeName': 'Tsipi', 'Initials': 'T', 'LastName': 'Knoll', 'Affiliation': 'Clalit Health Services, Haifa and Western Galilee, Haifa, Israel.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Livne', 'Affiliation': 'Department of Physical Therapy, Zefat Academic College, Safed, Israel.'}, {'ForeName': 'Yocheved', 'Initials': 'Y', 'LastName': 'Laufer', 'Affiliation': 'Department of Physical Therapy, School of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}]",Disability and rehabilitation,['10.1080/09638288.2022.2080288']
1365,35653577,Efficacy of Intramuscular Ketorolac for Preventing Renal Colic Post Stent Removal: Randomized Controlled Trial.,"PURPOSE


The treatment of stones ureteroscopically is associated with postoperative pain, thought to be due largely to the use of ureteral stents. In some, stent removal precipitates renal colic that can last from minutes to hours. We sought to determine if intramuscular ketorolac could reduce post-stent removal renal colic.
MATERIALS AND METHODS


We performed a prospective, randomized, double-blind, placebo-controlled trial assessing the effects of ketorolac administered at time of stent removal. Patients were randomized to receive an intramuscular ketorolac 30 mg or placebo immediately prior to stent removal. Patients were contacted 1 and 7 days after stent removal to assess pain, need for opioids, emergency department or clinic visits and the need for surgical/medical interventions.
RESULTS


A total of 124 patients (62 patients each in the control and treatment groups) were included in the study. The groups were comparable in demographic/operative characteristics. No difference in mean pain scores or proportion of patients who experienced severe pain at 1 and 7 days post stent removal was detected between groups. However, use of ketorolac resulted in significantly fewer renal colic-related unplanned emergency department/clinic visits in the treatment group (2%) compared with the control group (13%, p=0.032).
CONCLUSIONS


Although administration of ketorolac prior to stent removal does not significantly reduce overall subjective pain experienced post stent removal compared to placebo, it does reduce the likelihood of severe renal colic requiring emergency department or office visits. Eligible patients may benefit from routine use of ketorolac injection at the time of stent removal.",2022,"Although administration of ketorolac prior to stent removal does not significantly reduce overall subjective pain experienced post-stent removal pain compared to placebo, it does reduce the likelihood of severe renal colic requiring emergency department or office visits.","['Patients were contacted 1 and 7 days after stent removal to assess pain, need for opioids, emergency department or clinic visits and the need for surgical/medical interventions', 'Renal Colic Post-stent Removal', '124 patients (62 patients each in the control and treatment groups) were included in the study']","['intramuscular ketorolac 30mg or placebo', 'ketorolac injection', 'ketorolac', 'placebo', 'Intramuscular Ketorolac']","['overall subjective pain', 'severe pain', 'renal colic-related unplanned ED/clinic visits', 'mean pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0522778', 'cui_str': 'Removal of stent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4050976', 'cui_str': 'Ketorolac Injection'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",124.0,0.203771,"Although administration of ketorolac prior to stent removal does not significantly reduce overall subjective pain experienced post-stent removal pain compared to placebo, it does reduce the likelihood of severe renal colic requiring emergency department or office visits.","[{'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Johnson', 'Affiliation': 'Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sorokin', 'Affiliation': 'Department of Urology, University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Antonelli', 'Affiliation': 'Department of Surgery, Division of Urology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pearle', 'Affiliation': 'Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",The Journal of urology,['10.1097/JU.0000000000002750']
1366,35654408,Clinical effect of CO 2  laser resection of the epiglottic cyst under micro-laryngoscope suspension.,"BACKGROUND


Epiglottic cysts are common diseases and have multiple morbidity, and traditional surgery causes intraoperative bleeding and postoperative recurrence.
OBJECTIVE


To investigate the therapeutic effect of CO 2  laser resection on epiglottic cyst when compared with traditional surgery.
METHOD


Eighty patients with epiglottic cysts were randomly enrolled into the CO 2  laser group (44 patients) and the high-frequency electrocautery group (36 patients).
RESULTS


The CO 2  laser group had a shorter operation time, less blood loss and fewer intraoperative ruptured cysts ( p  < .05). The duration of sore throat and the time before wound redness and swelling subsidence in the CO 2  laser group were significantly shorter than those in the high-frequency electrocautery group ( p  < .05). Within one year after the operation, the incidence of epiglottic scar contracture in the CO 2  laser group was significantly lower than that in the high-frequency electrocautery group ( p  < .05).
CONCLUSION


The CO 2  laser group has the advantages of minimally invasive, less bleeding, short operation time and less postoperative complications, and it is worthy of applying as clinical routine to treat epiglottic cysts.",2022,"The CO 2  laser group had a shorter operation time, less blood loss and fewer intraoperative ruptured cysts ( p  < .05).","['group (36 patients', 'Eighty patients with epiglottic cysts']","['CO 2  laser resection of the epiglottic cyst under micro-laryngoscope suspension', 'CO 2  laser resection', 'CO 2  laser group (44 patients) and the high-frequency electrocautery']","['shorter operation time', 'duration of sore throat and the time before wound redness and swelling subsidence', 'incidence of epiglottic scar contracture', 'bleeding, short operation time and less postoperative complications', 'blood loss and fewer intraoperative ruptured cysts']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1112638', 'cui_str': 'Cyst of epiglottis'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1112638', 'cui_str': 'Cyst of epiglottis'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0333140', 'cui_str': 'Ruptured simple cyst'}]",80.0,0.02211,"The CO 2  laser group had a shorter operation time, less blood loss and fewer intraoperative ruptured cysts ( p  < .05).","[{'ForeName': 'Dengsheng', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of otolaryngology, People's Hospital of Xuancheng City, the Affiliated Xuancheng Hospital of Wannan Medical College, Xuancheng City, Anhui Province, China.""}, {'ForeName': 'Maoli', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Department of Otolaryngology Head and Neck Surgery & Audiology and Neurotology, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.'}]",Acta oto-laryngologica,['10.1080/00016489.2022.2079717']
1367,35655149,Cognitive behavioural group therapy as addition to psychoeducation and pharmacological treatment for adolescents with ADHD symptoms and related impairments: a randomised controlled trial.,"BACKGROUND


Cognitive behavioural therapy (CBT) is recommended for attention-deficit/hyperactivity-disorder (ADHD) in adolescents. However, all CBTs are not created equal, and the guidelines do not specify which CBT interventions are the most effective for this patient group. This study examines the efficacy of a group CBT without parent involvement as follow-up treatment compared to no additional CBT in adolescents with persistent and impairing ADHD symptoms after a short psychoeducational intervention and medical treatment.
METHODS


The authors conducted a two-arm parallel randomized controlled trial in two child and adolescent mental health outpatient clinics in Norway. One hundred patients aged 14-18 years with a diagnosis of ADHD (66%) or subthreshold ADHD (34%) were randomized to either a 12-week group CBT program (N = 50) or a non-CBT control condition (N = 50). Assessments were made at admission to the clinic, two weeks before and two weeks after treatment. The primary outcomes were parent-, teacher- and self-ratings of ADHD symptoms (ADHD Rating Scale-IV), and the secondary outcomes were ratings of ADHD symptom severity, executive function, functional impairment, and emotional problems. Evaluators blinded to group allocation rated ADHD symptom severity with the Clinical Global Impression Scale for Severity (CGI-S) at baseline and post-treatment.
RESULTS


Analyses using mixed-effects models showed no difference between the treatment arms from baseline to post treatment in primary and secondary outcomes.
CONCLUSIONS


Contrary to our hypothesis, we found no incremental treatment effect on the part of a group CBT as follow-up to psychoeducation and pharmacological treatment on ADHD symptoms and accompanying impairments. Limitations with the CBT was the large number and low dosage of treatment components, causing restricted time for practice. Unlike evidence-based, individualized targeted CBTs with parent involvement, a group CBT directed solely at the adolescents with no parent involvement does not appear effective for treating ADHD.
TRIAL REGISTRATION


NCT02937142 , 18/10/2016.",2022,"RESULTS


Analyses using mixed-effects models showed no difference between the treatment arms from baseline to post treatment in primary and secondary outcomes.
","['One hundred patients aged 14-18\u2009years with a diagnosis of ADHD (66%) or subthreshold ADHD (34', 'adolescents with persistent and impairing ADHD symptoms after a short psychoeducational intervention and medical treatment', 'two child and adolescent mental health outpatient clinics in Norway', 'adolescents with ADHD symptoms and related impairments']","['Cognitive behavioural therapy (CBT', 'CBT', 'Cognitive behavioural group therapy', 'psychoeducation and pharmacological treatment', 'CBT program (N\u2009=\u200950) or a non-CBT control condition']","['ADHD symptom severity with the Clinical Global Impression Scale for Severity (CGI-S', 'parent-, teacher- and self-ratings of ADHD symptoms (ADHD Rating Scale-IV), and the secondary outcomes were ratings of ADHD symptom severity, executive function, functional impairment, and emotional problems']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}]",100.0,0.127364,"RESULTS


Analyses using mixed-effects models showed no difference between the treatment arms from baseline to post treatment in primary and secondary outcomes.
","[{'ForeName': 'Anne-Lise Juul', 'Initials': 'AJ', 'LastName': 'Haugan', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), NTNU- Norwegian University of Science and Technology, Trondheim, Norway. anne-lise.j.haugan@ntnu.no.'}, {'ForeName': 'Anne Mari', 'Initials': 'AM', 'LastName': 'Sund', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), NTNU- Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Psychology Services Limited, London, UK.'}, {'ForeName': 'Per Hove', 'Initials': 'PH', 'LastName': 'Thomsen', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), NTNU- Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), NTNU- Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Torunn Stene', 'Initials': 'TS', 'LastName': 'Nøvik', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), NTNU- Norwegian University of Science and Technology, Trondheim, Norway.'}]",BMC psychiatry,['10.1186/s12888-022-04019-6']
1368,35656777,"Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial.","WHAT IS THIS SUMMARY ABOUT?


This is a summary of a publication about the ARASENS trial, which was published in the  New England Journal of Medicine  in February 2022. The trial includes 1,306 men with a type of prostate cancer called metastatic, hormone-sensitive prostate cancer (also called mHSPC). In the trial, researchers wanted to learn if combining a treatment called darolutamide (also known by the brand name Nubeqa ® ) with two other medicines called androgen deprivation therapy (also called ADT) and docetaxel (brand name Taxotere ® ) could help treat patients with mHSPC better than placebo plus ADT and docetaxel. ADT with docetaxel is a treatment used for patients with mHSPC. Darolutamide is an approved treatment for a different type of prostate cancer called non-metastatic, castration-resistant prostate cancer (also called nmCRPC).
WHAT WERE THE RESULTS?


The trial results showed that combining darolutamide with ADT and docetaxel increased the chance of survival and lowered the risk of death by 32.5% compared to combining ADT and docetaxel with placebo instead. Compared to patients who received the placebo, patients who received darolutamide had a delay in: their cancer becoming castration-resistant worsening pain having cancer-related bone fractures or related symptoms needing additional therapies for cancer The percentage of trial patients who had medical problems during the trial, also called adverse events, was similar between trial patients who received darolutamide and those who received the placebo.
WHAT DO THE RESULTS OF THE STUDY MEAN?


Combining darolutamide with ADT and docetaxel helped treat trial patients with mHSPC better than placebo with ADT and docetaxel. Darolutamide in combination with ADT and docetaxel could be a treatment option for patients with mHSPC. Patients should always talk to their doctors and nurses before making any decisions about their treatment. This summary also includes perspectives on the ARASENS trial and prostate cancer from 3 members of the patient community. ClinicalTrials.gov NCT number: NCT02799602.",2022,"Compared to patients who received the placebo, patients who received darolutamide had a delay in: their cancer becoming castration-resistant worsening pain having cancer-related bone fractures or related symptoms needing additional therapies for cancer The percentage of trial patients who had medical problems during the trial, also called adverse events, was similar between trial patients who received darolutamide and those who received the placebo.
","['prostate cancer from 3 members of the patient community', '1,306 men with a type of prostate cancer called metastatic, hormone-sensitive prostate cancer (also called mHSPC', 'patients with mHSPC']","['ADT and docetaxel', 'placebo plus ADT and docetaxel', 'medicines called androgen deprivation therapy (also called ADT) and docetaxel (brand name Taxotere ® ', 'darolutamide', 'ADT with docetaxel', 'placebo with ADT and docetaxel', 'placebo']","['risk of death', 'Darolutamide and survival', 'chance of survival']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0699967', 'cui_str': 'Taxotere'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1306.0,0.255898,"Compared to patients who received the placebo, patients who received darolutamide had a delay in: their cancer becoming castration-resistant worsening pain having cancer-related bone fractures or related symptoms needing additional therapies for cancer The percentage of trial patients who had medical problems during the trial, also called adverse events, was similar between trial patients who received darolutamide and those who received the placebo.
","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'University of Montreal Hospital Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Department of Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crawford', 'Affiliation': 'UC San Diego School of Medicine, San Diego, CA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Manarite', 'Affiliation': 'Caregiver Author.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muslin', 'Affiliation': 'Patient Author.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Farrington', 'Affiliation': 'Patient Author.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Division of Urology, IREC, Cliniques Universitaires Saint Luc, UCLouvain, Brussels, Belgium.'}]","Future oncology (London, England)",['10.2217/fon-2022-0433']
1369,35657073,Two-day  versus  seven-day course of levofloxacin in acute COPD exacerbation: a randomized controlled trial.,"INTRODUCTION


Duration of antibiotic treatment in acute exacerbation of COPD (AECOPD) is most commonly based on expert opinion. Typical administration periods range from 5 to 7 days. A 2-day course with levofloxacin was not previously assessed. We performed a randomized clinical trial to evaluate the efficacy of 2-day  versus  7-day treatment with levofloxacin in patients with AECOPD.
METHODS AND ANALYSIS


Patients with AECOPD were randomized to receive levofloxacin for 2 days and 5 days placebo ( n  = 155) or levofloxacin for 7 days ( n  = 155). All patients received a common dose of intravenous prednisone daily for 5 days. The primary outcome measure was cure rate, and secondary outcomes included need for additional antibiotics, ICU admission rate, re-exacerbation rate, death rate, and exacerbation-free interval (EFI) within 1-year follow-up. The study protocol has been prepared in accordance with the revised Helsinki Declaration for Biomedical Research Involving Human Subjects and Guidelines for Good Clinical Practice. The study was approved by ethics committees of all participating centers prior to implementation (Monastir and Sousse Universities).
RESULTS


310 patients were randomized to receive 2-day course of levofloxacin ( n  = 155) or 7-day course ( n  = 155). Cure rate was 79.3% ( n  = 123) and 74.2% ( n  = 115), respectively, in 2-day and 7-day groups [OR 1.3; 95% CI 0.78-2.2 ( p  = 0.28)]. Need for additional antibiotics rate was 3.2% and 1.9% in the 2-day group and 7-day group, respectively; ( p  = 0.43). ICU admission rate was not significantly different between both groups. One-year re-exacerbation rate was 34.8% ( n  = 54) in 2-day group  versus  29% ( n  = 45) in 7-day group ( p  = 0.19); the EFI was 121 days (interquartile range, 99-149)  versus  110 days (interquartile range, 89-132) in 2-day and 7-day treatment groups, respectively; ( p  = 0.73). One-year death rate was not significantly different between the 2 groups, 5.2%  versus  7.1% in the 2-day group and 7-day group, respectively; ( p  = 0.26). No difference in adverse effects was detected.
CONCLUSION


Levofloxacin once daily for 2 days is not inferior to 7 days with respect to cure rate, need for additional antibiotics and hospital readmission in AECOPD. Our findings would improve patient compliance and reduce the incidence of bacterial resistance and adverse effects.",2022,"One-year death rate was not significantly different between the 2 groups, 5.2%  versus  7.1% in the 2-day group and 7-day group, respectively; ( p  = 0.26).","['acute COPD exacerbation', 'participating centers prior to implementation (Monastir and Sousse Universities', '310 patients', 'patients with AECOPD', 'acute exacerbation of COPD (AECOPD', 'Patients with AECOPD']","['levofloxacin', 'intravenous prednisone', 'placebo', 'Levofloxacin']","['death rate', 'incidence of bacterial resistance and adverse effects', 'Cure rate', 'cure rate, and secondary outcomes included need for additional antibiotics, ICU admission rate, re-exacerbation rate, death rate, and exacerbation-free interval (EFI', 'adverse effects', 'cure rate, need for additional antibiotics and hospital readmission', 'ICU admission rate', 'exacerbation rate', 'additional antibiotics rate']","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151521', 'cui_str': 'Bacterial resistance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0081934', 'cui_str': 'Ef1 protein, rat'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",310.0,0.484303,"One-year death rate was not significantly different between the 2 groups, 5.2%  versus  7.1% in the 2-day group and 7-day group, respectively; ( p  = 0.26).","[{'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Messous', 'Affiliation': 'Research Laboratory LR12SP18, Monastir University, Monastir, Tunisia.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Trabelsi', 'Affiliation': 'Research Laboratory LR12SP18, Monastir University, Monastir, Tunisia.'}, {'ForeName': 'Khaoula', 'Initials': 'K', 'LastName': 'Bel Haj Ali', 'Affiliation': 'Emergency Department and Laboratory Research (LR12SP18), Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdelghani', 'Affiliation': 'Pneumology Department, Farhat Hached University Hospital, Sousse, Tunisia.'}, {'ForeName': 'Yosra', 'Initials': 'Y', 'LastName': 'Ben Daya', 'Affiliation': 'Medis Laboratories, Tunis, Tunisia.'}, {'ForeName': 'Rabie', 'Initials': 'R', 'LastName': 'Razgallah', 'Affiliation': 'DACIMA Consulting, Tunis, Tunisia.'}, {'ForeName': 'Mohamed Habib', 'Initials': 'MH', 'LastName': 'Grissa', 'Affiliation': 'Emergency Department and Laboratory Research (LR12SP18), Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Kaouthar', 'Initials': 'K', 'LastName': 'Beltaief', 'Affiliation': 'Emergency Department and Laboratory Research (LR12SP18), Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Zied', 'Initials': 'Z', 'LastName': 'Mezgar', 'Affiliation': 'Emergency Department, Farhat Hached University Hospital, Sousse, Tunisia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Belguith', 'Affiliation': 'Department of Preventive Medicine, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Wahid', 'Initials': 'W', 'LastName': 'Bouida', 'Affiliation': 'Emergency Department and Laboratory Research (LR12SP18), Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Riadh', 'Initials': 'R', 'LastName': 'Boukef', 'Affiliation': 'Emergency Department, Sahloul University Hospital, Sousse, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Boubaker', 'Affiliation': 'Emergency Department and Laboratory Research (LR12SP18), Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Msolli', 'Affiliation': 'Emergency Department and Laboratory Research (LR12SP18), Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Sekma', 'Affiliation': 'Emergency Department and Laboratory Research (LR12SP18), Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Semir', 'Initials': 'S', 'LastName': 'Nouira', 'Affiliation': 'Research Laboratory LR12SP18, Monastir University, Tunisia.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666221099729']
1370,35659547,"Long-acting HIV fusion inhibitor albuvirtide combined with ritonavir-boosted lopinavir for HIV-1-infected patients after failing the first-line antiretroviral therapy: 48-week randomized, controlled, phase 3 non-inferiority TALENT study.",,2022,,['HIV-1-infected patients after failing the first-line antiretroviral therapy'],['ritonavir-boosted lopinavir'],[],"[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}]",[],,0.236881,,"[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Su', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Qing-Xia', 'Initials': 'QX', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, Infectious Disease Hospital of Henan Province, Zhengzhou, Henan 450061, China.'}, {'ForeName': 'Wei-Ping', 'Initials': 'WP', 'LastName': 'Cai', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, Guangdong 510060, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Institute of HIV/AIDS, the First Hospital of Changsha, Changsha, Hunan 410005, China.'}, {'ForeName': 'Hong-Zhou', 'Initials': 'HZ', 'LastName': 'Lu', 'Affiliation': 'Department of Infectious Diseases, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Mu', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Infectious Disease Hospital of Henan Province, Zhengzhou, Henan 450061, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Infectious Diseases, National Clinical Center for Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, Guangdong 518112, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Infectious Diseases, National Clinical Center for Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, Guangdong 518112, China.""}, {'ForeName': 'Yu-Huang', 'Initials': 'YH', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, the Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China.'}, {'ForeName': 'Ling-Hua', 'Initials': 'LH', 'LastName': 'Li', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, Guangdong 510060, China.""}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Chen', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, Guangdong 510060, China.""}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases, Xixi Hospital of Hangzhou, Hangzhou, Zhejiang 310023, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, the First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang 310003, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center for Infectious Diseases, the Fifth Medical Center of PLA General Hospital, Beijing 100039, China.'}, {'ForeName': 'Yong-Tao', 'Initials': 'YT', 'LastName': 'Sun', 'Affiliation': ""Department of Infectious Diseases, Tangdu Hospital, the Fourth Military Medical University, Xi'an Shaanxi 710038, China.""}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Lun', 'Affiliation': 'Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.'}, {'ForeName': 'Yi-Hang', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Sun', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Dai', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Tai-Yi', 'Initials': 'TY', 'LastName': 'Jiang', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Mei-Xia', 'Initials': 'MX', 'LastName': 'Wang', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Qing-Shan', 'Initials': 'QS', 'LastName': 'Zheng', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Peng', 'Affiliation': 'Beijing Co-CRO Medical Development Co., Ltd., Beijing 100711, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Co-CRO Medical Development Co., Ltd., Beijing 100711, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Rong-Jian', 'Initials': 'RJ', 'LastName': 'Lu', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Hu', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Cheng-Chen', 'Initials': 'CC', 'LastName': 'Sun', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': 'State Key Laboratory for Infectious Disease Prevention and Control, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Shao', 'Affiliation': 'State Key Laboratory for Infectious Disease Prevention and Control, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China. Electronic address: dxie@frontierbiotech.com.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China. Electronic address: zt_doc@ccmu.edu.cn.'}, {'ForeName': 'Fu-Jie', 'Initials': 'FJ', 'LastName': 'Zhang', 'Affiliation': 'Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China. Electronic address: treatment@chinaaids.cn.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China. Electronic address: whdoc@ccmu.edu.cn.'}]",The Journal of infection,['10.1016/j.jinf.2022.05.034']
1371,35660372,Targeting gut-brain axis through scalp-abdominal electroacupuncture in Parkinson's disease.,"BACKGROUND


Evidence suggests that the pathogenesis of Parkinson's disease (PD) is initiated in the gut rather than in the brain. Thus, targeting the gut in early stages may have the potential to halt disease progression and alleviate symptoms. Various acupuncture techniques have been used to treat patients with PD and have shown promising results. However, previous acupuncture techniques focused on the brain and motor symptoms. We aimed to determine if targeting PD patients' gut-brain axis through electroacupuncture could be an effective, safe, and low-cost therapeutic option for management of non-motor and motor symptoms.
METHODS


Thirty patients with mild to moderate PD were randomised into an intervention (n = 15) and a control group (n = 15). The intervention group received electroacupuncture twice a week for 30 min based on conventional drug treatment for 8 weeks. Conventional drug treatment was continued in the control group. The primary outcomes were changes in the score of clinical scales including the Non-motor Symptom Rating Scale (NMSS), PD Sleep Scale (PDSS), Bristol Stool Function Scale (BSFS), and Patient Associated Constipation and Quality of Life Scale (PAC-QOL). The secondary outcomes were the Unified PD Rating Scale (UPDRS) and Modified Hoehn-Yahr Staging Scale scores. Stool samples from the intervention group were collected before and after the procedure and were sent for gene sequencing. Adverse effects and personal impressions of the patients were noted during the course of the trial.
RESULT


An 8-week course of scalp-abdominal electroacupuncture treatment was effective in improving the NMSS, PDSS, and UPDRS scores in patients with PD. Further, there was statistical significance in the two subdomains of NMSS, namely sleep/fatigue and miscellaneous, further implying the efficacy of acupuncture on sleep disturbance. However, although the current acupuncture treatment was gut targeted, it had no effect on BSFS or PAC-QOL. Apart from improved UPDRS motor scores and activities of daily living scores, acupuncture had no significant impact on scores of mentation, behaviour, mood, and therapy complications. Acupuncture did not alter the Hoehn and Yahr stage. Significant alterations in gut bacterial composition were detected in nine taxa at the genus level. The relative abundances of the genera Bacteroides and Parasutterella were significantly increased after the intervention, whereas the abundances of the genera Dialister, Hungatella, Barnesiella, Megasphaera, Allisonella, Intestinimon, and Moryella were significantly lower.
CONCLUSION


An 8-week scalp-abdominal electroacupuncture treatment may be a complementary and alternative vehicle for PD patients. We detected nine taxa at the genus level which were significantly altered after treatment, emphasising the role of the gut-brain axis in the process.",2022,"Apart from improved UPDRS motor scores and activities of daily living scores, acupuncture had no significant impact on scores of mentation, behaviour, mood, and therapy complications.","['Thirty patients with mild to moderate PD', 'patients with PD', ""Parkinson's disease"", 'PD patients']","['Acupuncture', 'electroacupuncture', 'Scalp-Abdominal electroacupuncture', 'acupuncture', 'scalp-abdominal electroacupuncture']","['sleep disturbance', 'relative abundances of the genera Bacteroides and Parasutterella', 'BSFS or PAC-QOL', 'UPDRS motor scores and activities of daily living scores', 'abundances of the genera Dialister, Hungatella, Barnesiella, Megasphaera, Allisonella, Intestinimon, and Moryella', 'Unified PD Rating Scale (UPDRS) and Modified Hoehn-Yahr Staging Scale scores', 'scores of mentation, behaviour, mood, and therapy complications', 'score of clinical scales including the Non-motor Symptom Rating Scale (NMSS), PD Sleep Scale (PDSS), Bristol Stool Function Scale (BSFS), and Patient Associated Constipation and Quality of Life Scale (PAC-QOL', 'gut bacterial composition', 'Adverse effects and personal impressions', 'NMSS, PDSS, and UPDRS scores']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C2660976', 'cui_str': 'Parasutterella'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1008539', 'cui_str': 'Dialister'}, {'cui': 'C0317723', 'cui_str': 'Megasphaera'}, {'cui': 'C1225738', 'cui_str': 'Allisonella'}, {'cui': 'C1911062', 'cui_str': 'Moryella'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",30.0,0.0952643,"Apart from improved UPDRS motor scores and activities of daily living scores, acupuncture had no significant impact on scores of mentation, behaviour, mood, and therapy complications.","[{'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Nazarova', 'Affiliation': 'Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.'}, {'ForeName': 'Hongrong', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.'}, {'ForeName': 'Lufeng', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.'}, {'ForeName': 'Hedi', 'Initials': 'H', 'LastName': 'An', 'Affiliation': 'Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.'}, {'ForeName': 'Dongya', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai 200120, China.'}]",Brain research,['10.1016/j.brainres.2022.147956']
1372,35661010,"Comparison of laparoscopic and open surgery in hepatic hydatid disease in children: Feasibility, efficacy and safety.","Background


: Surgery continues to be the mainstay of treatment of hydatid cysts of the liver. Laparoscopy provides a lesser invasive tool for achieving results same as with the established open surgical techniques. The purpose of the study was to evaluate the feasibility and safety of laparoscopic management of hepatic hydatid disease in children.
Patients and Methods


It was a prospective randomised study conducted over a period of 7 years. Children with Gharbi Type I, II, III cysts, ≤3 cysts and superficial accessible cysts were treated laparoscopically and their outcomes were compared with matched controls treated by open approach.
Results


Sixty patients were included in the study with thirty patients in each matched group. Thirty paediatric patients (male 12:female 18) with 35 liver hydatid cysts underwent laparoscopic surgery. The mean cyst size was 8.8 ± 2.39 cm. Two patients needed conversion to open. No significant spillage of cyst contents was observed in any of the patients. Duration of hospital stay, time to removal of drains, duration of parenteral analgesia, severity of pain in postoperative period, time to ambulation and time to return to full orals were significantly lower in laparoscopic group compared to open group. Complication rates in both the groups were similar.
Conclusion


With proper patient selection, laparoscopic management of hydatid cysts of the liver in children is feasible and safe option with low morbidity, low rates of conversion and minimal complications.",2022,"Complication rates in both the groups were similar.
","['Children with Gharbi Type I, II, III cysts, ≤3 cysts and superficial accessible cysts', 'children', 'Thirty paediatric patients (male 12:female 18) with 35 liver hydatid cysts underwent', 'Sixty patients were included in the study with thirty patients in each matched group']","['\n\n\n', 'Laparoscopy', 'laparoscopic surgery', 'laparoscopic management', 'laparoscopic and open surgery']","['mean cyst size', 'Complication rates', 'Duration of hospital stay, time to removal of drains, duration of parenteral analgesia, severity of pain in postoperative period, time to ambulation and time to return to full orals', 'spillage of cyst contents', 'feasibility and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0013502', 'cui_str': 'Echinococcosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.00864231,"Complication rates in both the groups were similar.
","[{'ForeName': 'Pirzada Faisal', 'Initials': 'PF', 'LastName': 'Masood', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Gowhar Nazir', 'Initials': 'GN', 'LastName': 'Mufti', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Sajad Ahmad', 'Initials': 'SA', 'LastName': 'Wani', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Khurshid', 'Initials': 'K', 'LastName': 'Sheikh', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Aejaz Ahsan', 'Initials': 'AA', 'LastName': 'Baba', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Nisar Ahamd', 'Initials': 'NA', 'LastName': 'Bhat', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Raashid', 'Initials': 'R', 'LastName': 'Hamid', 'Affiliation': 'Department of Paediatric Surgery, GMC, Srinagar, Jammu and Kashmir, India.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_220_20']
1373,35660972,A prognostic score for patients with malignant pleural mesothelioma (MPM) receiving second-line immunotherapy or chemotherapy in the ETOP 9-15 PROMISE-meso phase III trial.,"INTRODUCTION


Clinical and laboratory parameters associated with response for patients with advanced pre-treated malignant pleural mesothelioma (MPM) are lacking. We aimed to identify prognostic and predictive markers among patients with relapsed MPM who were randomised into the ETOP 9-15 PROMISE-meso phase III trial, evaluating pembrolizumab and chemotherapy.
METHODS


Baseline clinical and laboratory parameters were investigated for prognostic or predictive value on progression-free survival (PFS) and overall survival (OS) in a retrospective analysis, based on the full cohort of 144 MPM patients. These consisted of immune-inflammatory indexes (neutrophil-lymphocyte ratio [NLR], systemic immune-inflammatory index [SII], lactate dehydrogenase [LDH]) along with other already known prognostic baseline characteristics and laboratory values. Cut-offs were chosen independently of outcome. Based on Cox multivariable analysis for PFS in the whole cohort, a risk factor model was built to illustrate the prognostic stratification of patients by the combination of the derived independent prognostic factors, taking into account the EORTC score, a validated prognostic score in MPM. All models were stratified by histology and adjusted by treatment.
RESULTS


In the stratified multivariable analysis in the whole cohort, high SII (hazard ratio (HR) 2.06; 95%CI 1.39-3.05) and low haemoglobin (HR 1.62; 95%CI 1.06-2.50) were associated with worse PFS. Based on these two prognostic factors, a mesothelioma risk score (MRS) was constructed with three PFS risk prognosis categories: favourable, intermediate and poor with 0, 1 and 2 risk factors, respectively (corresponding percent of cohort: 24%, 34% and 42% and median PFS: 5.8, 4.2 and 2.1 months). The derived MRS stratified the prognosis for PFS and OS, overall and within each of the EORTC groups. No significant predictors of treatment benefit were identified.
CONCLUSIONS


The proposed MRS is prognostic of patient outcome and it fine-tunes the prognosis of patients with pre-treated MPM alone or when used with the already established EORTC score.",2022,"In the stratified multivariable analysis in the whole cohort, high SII (hazard ratio (HR) 2.06; 95%CI 1.39-3.05) and low haemoglobin (HR 1.62; 95%CI 1.06-2.50) were associated with worse PFS.","['144 MPM patients', 'patients with advanced pre-treated malignant pleural mesothelioma (MPM', 'patients with relapsed MPM', 'patients with malignant pleural mesothelioma (MPM) receiving second-line']","['pembrolizumab and chemotherapy', 'immunotherapy or chemotherapy']","['immune-inflammatory indexes (neutrophil-lymphocyte ratio [NLR], systemic immune-inflammatory index [SII], lactate dehydrogenase [LDH', 'progression-free survival (PFS) and overall survival (OS', 'mesothelioma risk score (MRS']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0854891', 'cui_str': 'Pleural mesothelioma malignant recurrent'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0025500', 'cui_str': 'Mesothelioma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",144.0,0.0903326,"In the stratified multivariable analysis in the whole cohort, high SII (hazard ratio (HR) 2.06; 95%CI 1.39-3.05) and low haemoglobin (HR 1.62; 95%CI 1.06-2.50) were associated with worse PFS.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Luigi Banna', 'Affiliation': 'Candiolo Cancer Institute, FPO-IRCCCS, Candiolo, Turin, Italy; Portsmouth Hospitals University NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Addeo', 'Affiliation': 'Department of Medical Oncology, Geneva University Hospital (HUG), Genève, Switzerland.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Zygoura', 'Affiliation': 'Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'Zoi', 'Initials': 'Z', 'LastName': 'Tsourti', 'Affiliation': 'Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Lung Unit, Royal Marsden Hospital, and Division of Clinical Studies, Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Curioni-Fontecedro', 'Affiliation': 'Department of Medical Oncology and Hematology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Nadal', 'Affiliation': ""Catalan Institute of Oncology (ICO), L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Riyaz', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Medical Oncology, Kent Oncology Centre, Maidstone, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Pope', 'Affiliation': 'Department of Medical Oncology, Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Fisher', 'Affiliation': 'Department of Medical Oncology, Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Spicer', 'Affiliation': ""Department of Medical Oncology, King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Medical Oncology, University Hospital Plymouth, Plymouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gilligan', 'Affiliation': ""Department of Oncology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gautschi', 'Affiliation': 'University of Berne and Cantonal Hospital Luzern, Switzerland.'}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Janthur', 'Affiliation': 'Department of Medical Oncology, Cantonal Hospital Aarau, Switzerland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López-Castro', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario de Valladolid, Spain.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Roschitzki-Voser', 'Affiliation': 'Coordinating Center, European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'Urania', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': 'National and Kapodistrian University of Athens & Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Rolf A', 'Initials': 'RA', 'LastName': 'Stahel', 'Affiliation': 'Coordinating Center, European Thoracic Oncology Platform (ETOP), Bern, Switzerland. Electronic address: Rolf.Stahel@etop-eu.org.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2022.05.018']
1374,35661781,Enhancing adherence and management in patients with hypertension: Impact of form and frequency of knowledge intervention.,"BACKGROUND


The alarming rise in prevalence of hypertension warrants psychosocial methods supplementing pharmacotherapy for better management and prevention of cardiac emergencies. The objective of the study was to assess the differential impact of the form and frequency of knowledge intervention on management of primary hypertension.
MATERIALS AND METHOD


The study was conducted on 256 hypertensive patients recruited through purposive sampling at health centers in Hyderabad, India. Pretest post-test control group quasi-experimental design was adopted for the study. There were two forms of the knowledge intervention, namely 'Direct Interaction' and 'Audio-Visual'. Each form was presented in two frequencies namely 'single exposure' and 'double exposure'. The four groups were labelled as Direct Intervention Single (DIS), Direct Intervention Double (DID), Audio-Visual Single (AVS) and Audio-Visual Double (AVD). Adherence and management of hypertension were assessed at baseline and six weeks post experiment. Analysis of Covariance (ANCOVA) was applied using IBM SPSS Statistics version 20.
RESULTS


ANCOVA followed by Bonferroni Multiple Group Comparison Test revealed significant differences between the four intervention groups and control group on adherence (p< .001). In case of hypertension management significant differences were observed between Control group and DIS, DID (p < .001), Control and AVS (p < .01). Control group did not differ from AVD.
CONCLUSION


There was a positive impact of Knowledge Intervention on adherence and management of hypertension. Double exposure in audio visual form was counterproductive in hypertension management.",2022,"In case of hypertension management significant differences were observed between Control group and DIS, DID (P<.001), Control and AVS (P<.01).","['Patients with Hypertension', '256 hypertensive patients recruited through purposive sampling at health centers in Hyderabad, India']","['knowledge intervention', 'Direct Intervention Single (DIS), Direct Intervention Double (DID), Audio-Visual Single (AVS) and Audio-Visual Double (AVD']","[""knowledge intervention, namely 'Direct Interaction' and 'Audio-Visual"", 'Adherence and management of hypertension', 'adherence and management of hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",256.0,0.0157294,"In case of hypertension management significant differences were observed between Control group and DIS, DID (P<.001), Control and AVS (P<.01).","[{'ForeName': 'Asher', 'Initials': 'A', 'LastName': 'Andrew', 'Affiliation': 'Centre for Health Psychology, School of Medical Sciences, University of Hyderabad, Central University PO, Prof. C R Rao Road, Gachibowli, Hyderabad, 500046, Telangana, India. Electronic address: ashi.andrew@gmail.com.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Hariharan', 'Affiliation': 'Centre for Health Psychology, School of Medical Sciences, University of Hyderabad, Central University PO, Prof. C R Rao Road, Gachibowli, Hyderabad, 500046, Telangana, India. Electronic address: meenahariharan@uohyd.ac.in.'}, {'ForeName': 'Sandra Roshni', 'Initials': 'SR', 'LastName': 'Monteiro', 'Affiliation': 'Department of Applied Psychology, GITAM School of Humanities and Social Sciences, GITAM (Deemed to Be University), Hyderabad, 502329, Telangana, India. Electronic address: monteiro.san10@gmail.com.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Padhy', 'Affiliation': 'Centre for Health Psychology, School of Medical Sciences, University of Hyderabad, Central University PO, Prof. C R Rao Road, Gachibowli, Hyderabad, 500046, Telangana, India. Electronic address: meerapadhy@yahoo.com.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chivukula', 'Affiliation': 'Centre for Health Psychology, School of Medical Sciences, University of Hyderabad, Central University PO, Prof. C R Rao Road, Gachibowli, Hyderabad, 500046, Telangana, India. Electronic address: cvusha24@gmail.com.'}]",Indian heart journal,['10.1016/j.ihj.2022.06.002']
1375,35662238,Functional outcome and CEUS-assessed deltoid muscle vitality after fracture-specific versus standard prosthetic design in reverse shoulder arthroplasty for trauma.,"Functional outcome after reverse-shoulder-arthroplasty (RSA) in proximal humerus fractures (PHF) depends on deltoid muscle integrity and successful reattachment of the tuberosities for best possible recovery of rotator-cuff function. In this monocentric, prospective, randomized, controlled trial we investigated whether a reverse-fracture-prosthesis (RFP) with a metaphyseal fenestrated stem achieved superior shoulder and muscle function compared to a common reverse-prosthesis (RP) design for patients with PHF. Our hypothesis was that patients with RFP may achieve a superior healing rate of the greater tuberosity (GT) compared to patients receiving RP, which translates to significantly higher clinical outcome and functional scores as well as differences in deltoid muscle microperfusion. Forty-four patients with PHF were randomized preoperatively to one of the prosthesis types in RSA between 2018 and 2020 (22 with RFP and 22 with RP) and prospectively assessed 6 months after surgery. We assessed osteointegration of the GT with radiographs 1 day and 6 months postoperatively and examined shoulder function and patient satisfaction by using established shoulder scores. A contrast-enhanced ultrasound (CEUS) examination of both shoulders was performed to quantify intramuscular blood flow and evaluate vitality of the deltoid muscle. None of the functional and psychosocial scores or radiographs and ultrasound examinations showed significant differences between the RSA designs. The constant-Murley score (p = 0.384) and active anterior-elevation-abduction, and external rotation were comparable between the RFP and RP group. Similar healing rates of the GT were observed (p = 0.655). CEUS-assessed deltoid microperfusion revealed equivalent muscle vitality for both groups (p = 0.312). Level of evidence: Level II; Randomized Controlled Trial; Treatment Study. Clinical significance: The radiographic evaluation for the investigation of the GT healing rate indicates that the proclaimed benefits of the fracture prosthesis with fenestration design might not be as great as expected.",2022,CEUS-assessed deltoid microperfusion revealed equivalent muscle vitality for both groups (p = .312).,"['Forty-four patients with PHF', 'proximal humerus fractures (PHF', 'patients with PHF', 'reverse shoulder arthroplasty for trauma']","['reverse-shoulder-arthroplasty (RSA', 'reverse-fracture-prosthesis (RFP) with a metaphyseal fenestrated stem achieved superior shoulder and muscle function compared to a common reverse-prosthesis (RP']","['Constant-Murley score', 'functional and psychosocial scores or radiographs and ultrasound examinations', 'muscle vitality', 'active anterior-elevation-abduction, and external rotation', 'superior healing rate', 'healing rates', 'Functional outcome and CEUS-assessed deltoid muscle vitality']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0205214', 'cui_str': 'Common'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}]",44.0,0.0332677,CEUS-assessed deltoid microperfusion revealed equivalent muscle vitality for both groups (p = .312).,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Doll', 'Affiliation': 'Center for Orthopaedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Neide', 'Affiliation': 'Center for Orthopaedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mick', 'Affiliation': 'Center for Orthopaedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Brunnemer', 'Affiliation': 'Center for Orthopaedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schmidmaier', 'Affiliation': 'Center for Orthopaedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': 'Center for Orthopaedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, Heidelberg University Hospital, Heidelberg, Germany.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.25392']
1376,35662619,Correcting the reward imbalance in binge eating: A pilot randomized trial of reward re-training treatment.,"Behavioral treatments for psychological disorders characterized by reward-driven maladaptive behaviors (e.g., substance use disorder, eating disorders, behavioral addictions) primarily seek to reduce hyper-reward response to disorder-specific stimuli. Suboptimal outcomes for these treatments highlight the need to also target hypo-reward response to day-to-day life activities. The present study sought to conduct an initial test of a novel behavioral treatment, Reward Re-Training (RRT) to target hyper- and hypo-reward response in individuals with binge eating. Individuals with binge eating (N = 23) were randomly assigned to either 10 weeks of outpatient, group-based RRT treatment or a waitlist control. RRT was found to be feasible and acceptable, demonstrated large impacts on both hypo- and hyper-reward response (measured by self-report (pre-to post-treatment η p 2  range 0.38-0.58) and neural activation via fMRI), and was efficacious in reducing eating disorder pathology (η p 2  range 0.40-0.64, including binge eating, η p 2  = 0.64) compared to waitlist control (η p 2  range 0.00-0.04). This pilot data provides preliminary support for the feasibility, acceptability, and effectiveness of a novel treatment targeting reward imbalance for individuals with binge eating. Future evaluations of RRT may benefit from an active treatment comparison condition and a follow-up assessment to examine persistence of positive outcomes.",2022,"RRT was found to be feasible and acceptable, demonstrated large impacts on both hypo- and hyper-reward response (measured by self-report (pre-to post-treatment η p 2  range 0.38-0.58) and neural activation via fMRI), and was efficacious in reducing eating disorder pathology (η p 2  range 0.40-0.64, including binge eating, η p 2  = 0.64) compared to waitlist control (η p 2  range 0.00-0.04).","['individuals with binge eating', 'Individuals with binge eating (N\u202f=\u202f23', 'binge eating']","['RRT', 'RRT treatment or a waitlist control', 'novel behavioral treatment, Reward Re-Training (RRT', 'reward re-training treatment']","['eating disorder pathology', 'hypo- and hyper-reward response', 'neural activation via fMRI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",23.0,0.0254823,"RRT was found to be feasible and acceptable, demonstrated large impacts on both hypo- and hyper-reward response (measured by self-report (pre-to post-treatment η p 2  range 0.38-0.58) and neural activation via fMRI), and was efficacious in reducing eating disorder pathology (η p 2  range 0.40-0.64, including binge eating, η p 2  = 0.64) compared to waitlist control (η p 2  range 0.00-0.04).","[{'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Department of Psychology, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA; Center for Weight, Eating, and Lifestyle Science, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Presseller', 'Affiliation': 'Department of Psychology, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA; Center for Weight, Eating, and Lifestyle Science, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA. Electronic address: ekp55@drexel.edu.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Psychology, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA; Center for Weight, Eating, and Lifestyle Science, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA.'}, {'ForeName': 'Apoorva', 'Initials': 'A', 'LastName': 'Kelkar', 'Affiliation': 'Department of Psychology, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA.'}, {'ForeName': 'Paakhi', 'Initials': 'P', 'LastName': 'Srivastava', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA.'}, {'ForeName': 'Joanna Y', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dengler', 'Affiliation': 'Department of Bioengineering, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Manasse', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Medaglia', 'Affiliation': 'Department of Psychology, Drexel University, 3141 Chestnut St, Philadelphia, Pennsylvania, 19104, USA.'}]",Appetite,['10.1016/j.appet.2022.106103']
1377,35662679,Future-oriented imagery rescripting facilitates conducting behavioral experiments in social anxiety.,"Distressing mental images are common in anxiety disorders and can make it difficult for patients to confront feared situations. This study examined whether imagery rescripting focused on a feared social situation prepares participants to engage in a feared situation. Sixty healthy individuals were asked to formulate a behavioral experiment to test negative beliefs about a social situation they feared. They were assigned to one of two groups: imagery rescripting focused on the feared outcome of the behavioral experiment or no imagery rescripting (i.e., a break). All participants were then asked to complete ratings scales and to conduct the behavioral experiment. Before the behavioral experiment, the imagery rescripting condition, compared to the control condition, showed reduced anticipated probability and severity of the feared outcome, lower anxiety and helplessness levels, and increased willingness to conduct the behavioral experiment. Imagery-based interventions focused on feared outcomes seem promising to prepare anxious individuals to engage in treatment.",2022,"Before the behavioral experiment, the imagery rescripting condition, compared to the control condition, showed reduced anticipated probability and severity of the feared outcome, lower anxiety and helplessness levels, and increased willingness to conduct the behavioral experiment.",['Sixty healthy individuals'],"['Imagery-based interventions', 'behavioral experiment or no imagery rescripting']","['probability and severity of the feared outcome, lower anxiety and helplessness levels, and increased willingness to conduct the behavioral experiment']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",60.0,0.0346839,"Before the behavioral experiment, the imagery rescripting condition, compared to the control condition, showed reduced anticipated probability and severity of the feared outcome, lower anxiety and helplessness levels, and increased willingness to conduct the behavioral experiment.","[{'ForeName': 'Elze', 'Initials': 'E', 'LastName': 'Landkroon', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands. Electronic address: e.landkroon@tilburguniversity.edu.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Meyerbröker', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Salemink', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Behaviour research and therapy,['10.1016/j.brat.2022.104130']
1378,35658800,Effects of Low vs Moderate Dose of Recreational Football on Cardiovascular Risk Factors.,"This study aimed to compare the effectiveness of recreational football performed once (LOW) vs. twice (MOD) a week on cardiovascular risk factors in healthy, sedentary men. Body composition, resting blood pressure, blood lipid profile and maximal oxygen consumption (VO 2 max) were measured at baseline, after a 12-week control and training period, using an interrupted time series study (study 1, n=18: n=8, LOW and n=10, MOD) nested in a randomised parallel trial (study 2, n=34: n=18 LOW and n=16 MOD). After the intervention in the study 1, LDL-Cholesterol (-12.3 mg•dL- 1  [-22.7 to -2.0]) and VO 2 max (4.5 ml•kg-¹•min-¹ [1.2 to 7.8 ]) changed in LOW whereas differences were found in weight (-2.1 kg [-3.7 to -0.4]), BMI (-0.7 kg•m -2  [-1.2 to -0.1]), total cholesterol (-22.2 mg•dL- 1  [-36.0 to -8.4]), no-HDL-cholesterol (-17.5 mg•dL- 1  [-30.5 to -4.5]), LDL-cholesterol (-14.9 mg•dL- 1  [-23.6 to -6.2]) and VO 2 max (5.7 ml•kg-¹•min-¹ [2.8 to 8.6]) in MOD. Study 2 showed no evidence of differences between groups. Our results therefore, suggest positive health effects of recreational football even when performed at low frequency as it can happen in real context.",2022,Study 2 showed no evidence of differences between groups.,"['healthy, sedentary men', 'n=18 LOW and n=16 MOD', 'n=18: n=8, LOW and n=10, MOD) nested in a randomised parallel trial (study 2, n=34']",['recreational football performed once (LOW) vs. twice (MOD'],"['weight', 'BMI', 'total cholesterol', 'cardiovascular risk factors', 'LDL-cholesterol', 'Body composition, resting blood pressure, blood lipid profile and maximal oxygen consumption (VO 2 max', 'no-HDL-cholesterol', 'LDL-Cholesterol', 'Cardiovascular Risk Factors']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}]",,0.0303556,Study 2 showed no evidence of differences between groups.,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Modena', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Franco M', 'Initials': 'FM', 'LastName': 'Impellizzeri', 'Affiliation': 'University of Technology of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fornasiero', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}]",European journal of sport science,['10.1080/17461391.2022.2086488']
1379,35658728,Effect of oestriol gel on dyspareunia in postmenopausal women in 2 weeks of treatment: a pilot study.,"This brief report evaluates the early effect of ultra-low dose 0.005% oestriol vaginal gel on dyspareunia in postmenopausal women within the first 2 weeks of treatment. This was a prospective and multicentre single-arm pilot study and the effect of the treatment on dyspareunia was evaluated by using a diary. In total 23 women and 150 coitus were studied. 8 coitus were painless in the first week and 42 during the second week ( p  < .0001). A reduction in pain from the baseline was seen in 116 (77.3%) out of the 150 coitus. 0.005% oestriol vaginal gel produced a rapid and progressive improvement in dyspareunia from the very first days of treatment in postmenopausal women.IMPACT STATEMENT What is already known on this subject?  Local oestrogen therapy has shown efficacy in the treatment of genitourinary syndrome of menopause (GSM) and dyspareunia when used for a duration of greater than 3 weeks. What do the results of this study add?  This study shows that the use of oestriol gel produces clinical effects from the beginning of its use, decreasing dyspareunia in postmenopausal women within just 14 days of daily use. What are the implications of these findings for clinical practice and/or further research?  In cases of dyspareunia in relation to menopause, therapy with local oestrogens, in our case oestriol gel, produces an improvement from the beginning of its use. This information is clinically relevant when evaluating therapeutic options.",2022,8 coitus were painless in the first week and 42 during the second week ( p  < .0001).,"['postmenopausal women', 'In total 23 women and 150 coitus were studied', 'postmenopausal women in 2 weeks of treatment', 'postmenopausal women within the first 2 weeks of treatment', 'postmenopausal women within just 14 days of daily use']","['oestriol gel', 'Local oestrogen therapy', 'IMPACT', 'ultra-low dose 0.005% oestriol vaginal gel']","['dyspareunia', 'pain']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}]","[{'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",23.0,0.00788602,8 coitus were painless in the first week and 42 during the second week ( p  < .0001).,"[{'ForeName': 'Marcos J', 'Initials': 'MJ', 'LastName': 'Cuerva', 'Affiliation': 'Department of Gynaecology, Hospital San Francisco de Asís, Madrid, Spain.'}, {'ForeName': 'Silvia P', 'Initials': 'SP', 'LastName': 'González', 'Affiliation': 'Department of Gynaecology, Policlínico HM Gabinete Velázquez, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Lazaro-Carrasco De La Fuente', 'Affiliation': 'Department of Gynaecology, Clínica Arpa Médica, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Lopez', 'Affiliation': 'Centro Gaztambide de Ginecología y Obstetricia, Madrid, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Nieto', 'Affiliation': 'ITF Research Pharma S.L.U, Madrid, Spain.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2022.2081800']
1380,35659196,Clinical and cost-effectiveness of a personalised health promotion intervention enabling independence in older people with mild frailty ('HomeHealth') compared to treatment as usual: study protocol for a randomised controlled trial.,"BACKGROUND


Frailty is clinically associated with multiple adverse outcomes, including reduced quality of life and functioning, falls, hospitalisations, moves to long-term care and mortality. Health services commonly focus on the frailest, with highest levels of need. However, evidence suggests that frailty is likely to be more reversible in people who are less frail. Evidence is emerging on what interventions may help prevent or reduce frailty, such as resistance exercises and multi-component interventions, but few interventions are based on behaviour change theory. There is little evidence of cost-effectiveness. Previously, we co-designed a new behaviour change health promotion intervention (""HomeHealth"") to support people with mild frailty. HomeHealth is delivered by trained voluntary sector support workers over six months who support older people to work on self-identified goals to maintain their independence, such as strength and balance exercises, nutrition, mood and enhancing social engagement. The service was well received in our feasibility randomised controlled trial and showed promising effects upon outcomes.
AIM


To test the clinical and cost-effectiveness of the HomeHealth intervention on maintaining independence in older people with mild frailty in comparison to treatment as usual (TAU).
METHODS


Single-blind individually randomised controlled trial comparing the HomeHealth intervention to TAU. We will recruit 386 participants from general practices and the community across three English regions. Participants are included if they are community-dwelling, aged 65 + , with mild frailty according to the Clinical Frailty Scale. Participants will be randomised 1:1 to receive HomeHealth or TAU for 6 months. The primary outcome is independence in activities of daily living (modified Barthel Index) at 12 months. Secondary outcomes include instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality. Outcomes will be analysed using linear mixed models, controlling for baseline Barthel score and site. A health economic analysis and embedded mixed-methods process evaluation will be conducted.
DISCUSSION


This trial will provide definitive evidence on the effectiveness and cost-effectiveness of a home-based, individualised intervention to maintain independence in older people with mild frailty in comparison to TAU, that could be implemented at scale if effective.
TRIAL REGISTRATION


ISRCTN, ISRCTN54268283 . Registered 06/04/2020.",2022,"Secondary outcomes include instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality.","[""older people with mild frailty ('HomeHealth"", 'Participants are included if they are community-dwelling, aged 65\u2009+\u2009, with mild frailty according to the Clinical Frailty Scale', 'older people with mild frailty', 'older people with mild frailty in comparison to treatment as usual (TAU', 'people with mild frailty', '386 participants from general practices and the community across three English regions']","['HomeHealth intervention to TAU', 'HomeHealth or TAU', 'HomeHealth intervention', 'individualised intervention', 'personalised health promotion intervention', 'new behaviour change health promotion intervention (""HomeHealth']","['instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality', 'independence in activities of daily living (modified Barthel Index']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",386.0,0.234147,"Secondary outcomes include instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality.","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Frost', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK. rachael.frost@ucl.ac.uk.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Avgerinou', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Goodman', 'Affiliation': 'Centre for Research in Public Health and Community Care, University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clegg', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, University of Leeds, Bradford Institute for Health Research, Bradford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hopkins', 'Affiliation': 'Patient and Public Involvement Member, London, UK.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Gould', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gardner', 'Affiliation': ""Department of Psychology, King's College London, London, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Manthorpe', 'Affiliation': ""NIHR Policy Research Unit in Health and Social Care Workforce, King's College London, London, UK.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'Department of Physiotherapy and Paramedicine, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Vari M', 'Initials': 'VM', 'LastName': 'Drennan', 'Affiliation': ""Centre for Health and Social Care Research, Kingston University & St George's University, London, UK.""}, {'ForeName': 'Pip', 'Initials': 'P', 'LastName': 'Logan', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walters', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}]",BMC geriatrics,['10.1186/s12877-022-03160-x']
1381,35666231,"Dose Proportionality and Steady-State Pharmacokinetics of Serdexmethylphenidate/Dexmethylphenidate, a Novel Prodrug Combination to Treat Attention-Deficit/Hyperactivity Disorder.","Objective:  The study was designed to determine (1) the pharmacokinetic (PK) profile of dexmethylphenidate (d-MPH) after oral administration of three dosage strengths of a new treatment containing d-MPH and a novel prodrug, serdexmethylphenidate (SDX); (2) the dose proportionality of the different SDX/d-MPH dosages; and (3) the steady-state PK profile of d-MPH and SDX after multiple dosing of SDX/d-MPH.  Methods:  Twenty-three healthy volunteers (aged 18-55 years) under fasted conditions received in a crossover design SDX/d-MPH 26.1/5.2 mg (Treatment A), 39.2/7.8 mg (Treatment B), and 52.3/10.4 mg (Treatment C) for a total d-MPH hydrochloride equivalent dose of 20, 30, and 40 mg, respectively. After a 96-hour washout period, all participants received four consecutive daily doses of SDX/d-MPH 52.3/10.4 mg. Blood samples were collected for measurement of plasma d-MPH and SDX and for PK analysis.  Results:  Administration of all three doses of SDX/d-MPH resulted in a rapid rise and slow decline in the plasma concentration of d-MPH. For Treatments A, B, and C, mean (± standard deviation) maximum concentrations ( C max ) were 7.1 ± 2.1, 9.8 ± 2.8, and 13.8 ± 3.8 ng/mL, and overall exposures (AUC 0-last ) were 97.2 ± 28.8, 142.5 ± 41.2, and 199.8 ± 57.2 h*ng/mL, respectively. Dose-normalized  C max , AUC 0-last , and AUC 0-inf  for d-MPH were similar when comparing the high and low doses versus the middle dose. Power model regression analysis revealed that  C max  and AUC 0-inf  proportionally increased with an increase in SDX/d-MPH dose. In the multiple-dose study, d-MPH reached steady state before the third dose, and SDX after the first dose.  Conclusion:  The PK profile of SDX/d-MPH is characterized by a rapid rise and a gradual decline in d-MPH concentration, with proportional  C max  and AUC 0-inf  across doses. The PK attributes of SDX/d-MPH may optimize symptom control from early morning to early evening, while the demonstrated dose proportionality may facilitate initial dose titration and ongoing dose adjustment.",2022,Power model regression analysis revealed that  C max  and AUC 0-inf  proportionally increased with an increase in SDX/d-MPH dose.,['Twenty-three healthy volunteers (aged 18-55 years) under fasted conditions'],"['SDX/d-MPH 52.3/10.4\u2009mg', 'SDX', 'Serdexmethylphenidate/Dexmethylphenidate', 'dexmethylphenidate (d-MPH', 'novel prodrug, serdexmethylphenidate (SDX']","['Dose-normalized  C max , AUC 0-last , and AUC 0-inf  for d-MPH', 'C max  and AUC 0-inf', 'maximum concentrations ( C max ']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1169997', 'cui_str': 'dexmethylphenidate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1169997', 'cui_str': 'dexmethylphenidate'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",23.0,0.125496,Power model regression analysis revealed that  C max  and AUC 0-inf  proportionally increased with an increase in SDX/d-MPH dose.,"[{'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Braeckman', 'Affiliation': 'KemPharm, Inc., Celebration, Florida, USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Guenther', 'Affiliation': 'KemPharm, Inc., Celebration, Florida, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Mickle', 'Affiliation': 'KemPharm, Inc., Celebration, Florida, USA.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Barrett', 'Affiliation': 'KemPharm, Inc., Celebration, Florida, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'KemPharm, Inc., Celebration, Florida, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Corium, Inc., Grand Rapids, Michigan, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2022.0015']
1382,35676679,A pragmatic multi-setting lifestyle intervention to improve leisure-time physical activity from adolescence to young adulthood: the vital role of sex and intervention onset time.,"BACKGROUND


The long-term effectiveness of healthy lifestyle interventions on improving leisure-time physical activity (LTPA) in adolescents and its factors in low- and middle-income communities is unclear. This study is the first to investigate LTPA trends in a population of Iranian adolescents who underwent a multi-setting lifestyle intervention, considering sex and the time of intervention onset.
METHODS


Participants were 2374 adolescents (57.2% girls), aged 12-18 years, who participated in the Tehran Lipid and Glucose Study (TLGS) during 1999-2001 and followed for a median follow-up of 15.9 over five data points every 3 years. Adolescent participants were assigned to the intervention or control groups based on their residential areas. Boys and girls were categorized into 12-15 or 16-18 years old to minimize participants' bio-psychological differences, facilitate environmental interventions by more compliance with the Iranian educational system and identify the best time to start the intervention. All adolescents in the intervention area received healthy lifestyle interventions via the school-, family-, and community-based programs. LTPA was assessed using the reliable and validated Iranian Modifiable Activity Questionnaire (MAQ) version over the five data points. The Generalized Estimating Equations method was used to evaluate educational intervention's effect on LTPA in adolescents during the follow-up.
RESULTS


In boys who experienced the early onset of intervention (12-15 years), the interaction effect of follow-up examinations and the intervention was significant where the impact of the intervention differed over time. In this group, LTPA was higher in the control group than in the intervention group at the first follow-up examination (β = - 1088.54). However, an increasing trend of LTPA was observed in the intervention group until the third follow-up examination (β = 1278.21, p = 0.08, and β = 1962.81, p = 0.02, respectively), with borderline significance levels at the 2nd (P = 0.08) and the 4th (P = 0.08) measurements. The interaction terms and main effects of intervention and follow-up examinations were not significant in boys with late intervention onset. Although older boys in the intervention group had higher LTPA than the control group, there were no significant differences among study groups in all follow-up examinations. Regarding girls, LTPA did not differ significantly between intervention and control groups in all follow-up examinations (P > 0.05).
CONCLUSION


Our results showed that a multi-setting practical lifestyle intervention could improve long-term energy expenditure in LTPA in adolescent boys who have experienced an early onset intervention. Findings emphasized the vital role of gender and the onset of these interventions. The current results would be valuable to plan tailored interventions to improve LTPA and community health.
TRIAL REGISTRATION


This study is registered at Iran Registry for Clinical Trials (IRCT), a WHO primary registry ( http://irct.ir ). The TLGS clinical trial was the very first registration in the IRCT (Iran Registry of Clinical Trials). it was registered on 2008-10-29 by the registration number IRCT138705301058N1 . Based on the international committee of medical journal Editors (ICMJE), ""retrospective registration"" is acceptable for trials that began before July 1, 2005.",2022,"In this group, LTPA was higher in the control group than in the intervention group at the first follow-up examination (β = - 1088.54).","['adolescents during the follow-up', 'adolescent boys who have experienced an early onset intervention', 'adolescents and its factors in low- and middle-income communities', 'adolescence to young adulthood', 'Adolescent participants', 'boys with late intervention onset', 'Iranian adolescents who underwent a multi-setting lifestyle intervention, considering sex and the time of intervention onset', 'Participants were 2374 adolescents (57.2% girls), aged 12-18\u2009years, who participated in the Tehran Lipid and Glucose Study (TLGS) during 1999-2001 and followed for a median follow-up of 15.9 over five data points every 3 years']","['LTPA', 'healthy lifestyle interventions', 'healthy lifestyle interventions via the school-, family-, and community-based programs']","['reliable and validated Iranian Modifiable Activity Questionnaire (MAQ) version', 'LTPA', 'leisure-time physical activity (LTPA']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",2374.0,0.0222224,"In this group, LTPA was higher in the control group than in the intervention group at the first follow-up examination (β = - 1088.54).","[{'ForeName': 'Parnian', 'Initials': 'P', 'LastName': 'Parvin', 'Affiliation': 'Research Center for Social Determinants of Health, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Amiri', 'Affiliation': 'Research Center for Social Determinants of Health, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. amiri@endocrine.ac.ir.'}, {'ForeName': 'Hasti', 'Initials': 'H', 'LastName': 'Masihay-Akbar', 'Affiliation': 'Research Center for Social Determinants of Health, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Khalafehnilsaz', 'Affiliation': 'Research Center for Social Determinants of Health, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cheraghi', 'Affiliation': 'Research Center for Social Determinants of Health, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ghanbarian', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-022-01301-4']
1383,35676616,New challenges of fetal therapy in Japan.,"AIM


To review new challenges of fetal therapy in Japan after the establishment of four existing fetal therapies as standard prenatal care with National Health Insurance coverage over the past 20 years.
METHODS


Reported studies and our current research activities related to four fetal therapies newly performed in Japan were reviewed.
RESULTS


Fetoscopic endoluminal tracheal occlusion (FETO) for congenital diaphragmatic hernia (CDH) aims to occlude the trachea using a detachable balloon to promote lung growth. Following the recent successful completion of an international randomized controlled trial for CDH, in which we participated, FETO is offered for severe left CDH to perform balloon insertion at 27-29 weeks and removal at 34 weeks of gestation. Fetal cystoscopy (FC) for low urinary tract obstruction was introduced to overcome the demerits of vesicoamniotic shunting. FC may provide a proper diagnosis by visual observation of the urethra and physiological treatment of the posterior urethral valve. The effectiveness of open fetal surgery for myelomeningocele (MMC), direct surgery with laparotomy and hysterotomy, for ameliorating hindbrain herniation and the motor function was demonstrated, but it was also associated with substantial maternal and fetal risks. Fetal aortic valvuloplasty (FAV), ultrasound-guided fetal aortic balloon dilation for critical aortic stenosis with evolving hypoplastic left heart syndrome may improve left heart development and maintain biventricular circulation. Feasibility and safety studies for FC, MMC open fetal surgery, and FAV are currently ongoing.
CONCLUSIONS


Clinical research on FETO, FC, MMC open fetal surgery, and FAV has proceeded with careful preparations in Japan.",2022,"The effectiveness of open fetal surgery for myelomeningocele (MMC), direct surgery with laparotomy and hysterotomy, for ameliorating hindbrain herniation and the motor function was demonstrated, but it was also associated with substantial maternal and fetal risks.","['congenital diaphragmatic hernia (CDH', 'Reported studies and our current research activities related to four fetal therapies newly performed in Japan were reviewed', 'Japan after the establishment of four existing fetal therapies as standard prenatal care with National Health Insurance coverage over the past 20\u2009years', 'Japan']","['open fetal surgery for myelomeningocele (MMC), direct surgery with laparotomy and hysterotomy', 'Fetal aortic valvuloplasty (FAV), ultrasound-guided fetal aortic balloon dilation', 'Fetoscopic endoluminal tracheal occlusion (FETO', 'Fetal cystoscopy (FC']",[],"[{'cui': 'C0235833', 'cui_str': 'Congenital diaphragmatic hernia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0015952', 'cui_str': 'Foetal therapeutic procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1261465', 'cui_str': 'Operation on fetus'}, {'cui': 'C0025312', 'cui_str': 'Meningomyelocele'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0020711', 'cui_str': 'Incision of uterus'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0396949', 'cui_str': 'Valvuloplasty of aortic valve'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]",[],,0.0698606,"The effectiveness of open fetal surgery for myelomeningocele (MMC), direct surgery with laparotomy and hysterotomy, for ameliorating hindbrain herniation and the motor function was demonstrated, but it was also associated with substantial maternal and fetal risks.","[{'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Wada', 'Affiliation': 'Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Katsusuke', 'Initials': 'K', 'LastName': 'Ozawa', 'Affiliation': 'Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Sago', 'Affiliation': 'Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.15320']
1384,35678785,"Hypericum and neem oil for dehisced post-surgical wounds: a randomised, controlled, single-blinded phase III study.","OBJECTIVE


To evaluate the clinical efficacy of a hypericum and neem oil dressing, Primary Wound Dressing [ONE] (1PWD) (Kerecis AG, Switzerland), in a patient population with dehiscence of surgical wounds with critical colonisation/infection. Efficacy was defined as resolution of inflammatory/infective symptoms.
METHOD


A randomised, controlled, single-blinded, parallel-arms phase III study was conducted comparing the experimental medication to silver-based dressings. All patients were evaluated at enrolment, on days 7, 14, 21 and 28. Improvement of inflammatory/infective symptoms was measured by detecting seven items of the Bates-Jensen Wound Assessment Tool (BWAT). Pain was assessed using the Numeric Rating Scale (NRS).
RESULTS


The study enrolled 99 patients. Follow-up was completed in 49 patients in the experimental group and 48 patients in the control group. Overall BWAT evaluation demonstrated similar outcomes between the groups: t=0.23, p-value=0.81, 95% confidence interval (CI): -13.3-10.8. Furthermore, when evaluating the seven items of the BWAT relating to inflammatory signs, there was not a significant difference between the groups: t=0.38, p=0.35, 95% CI: -2.8-2.7. However, when an analysis using the NRS pain scale was performed, a statistically significant pain reduction was demonstrated in favour of the experimental group: t=7.8, p<0.0001, 95% CI: 2.918-4.8819.
CONCLUSION


This randomised controlled trial confirmed the efficacy of 1PWD, an investigational product, in the management of surgical dehiscence with critical colonisation or infection, with the added benefit of significant pain reduction when compared with a silver-based dressing.",2022,"This randomised controlled trial confirmed the efficacy of 1PWD, an investigational product, in the management of surgical dehiscence with critical colonisation or infection, with the added benefit of significant pain reduction when compared with a silver-based dressing.","['49 patients in the experimental group and 48 patients in the control group', 'enrolled 99 patients', 'patient population with dehiscence of surgical wounds with critical colonisation/infection', 'dehisced post-surgical wounds']","['hypericum and neem oil dressing, Primary Wound Dressing [ONE] (1PWD) (Kerecis AG, Switzerland', 'silver-based dressings', 'Hypericum and neem oil']","['Improvement of inflammatory/infective symptoms', 'resolution of inflammatory/infective symptoms', 'NRS pain scale', 'Numeric Rating Scale (NRS', 'Efficacy', 'pain reduction', 'Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0038940', 'cui_str': 'Dehiscence of surgical wound'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}]","[{'cui': 'C1256259', 'cui_str': 'Hypericum'}, {'cui': 'C0068484', 'cui_str': 'neem oil'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",99.0,0.10269,"This randomised controlled trial confirmed the efficacy of 1PWD, an investigational product, in the management of surgical dehiscence with critical colonisation or infection, with the added benefit of significant pain reduction when compared with a silver-based dressing.","[{'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Oncology, Azienda Ospedaliera Garibaldi, Catania, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Strazzeri', 'Affiliation': ""Azienda Ospedaliero Universitaria Policlinico 'G.Rodolico - San Marco', Catania, Italy.""}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Bianchi', 'Affiliation': 'Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Peghetti', 'Affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Merli', 'Affiliation': 'Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Abbenante', 'Affiliation': 'Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Olivari', 'Affiliation': 'Clinica Medica, Università Politecnica delle Marche, Ancona, Italy.'}]",Journal of wound care,['10.12968/jowc.2022.31.6.492']
1385,35679193,Economic evaluation of the e-Health StandingTall balance exercise programme for fall prevention in people aged 70 years and over.,"BACKGROUND


globally, falls and fall-related injuries are the leading cause of injury-related morbidity and mortality in older people. In our ageing society healthcare costs are increasing, therefore programmes that reduce falls and are considered value for money are needed.
OBJECTIVE


to complete an economic evaluation of an e-Health balance exercise programme that reduced falls and injurious falls in community-dwelling older people compared to usual care from a health and community-care funder perspective.
DESIGN


a within-trial economic evaluation of an assessor-blinded randomised controlled trial with 2 years of follow-up.
SETTING


StandingTall was delivered via tablet-computer at home to older community-dwelling people in Sydney, Australia.
PARTICIPANTS


five hundred and three individuals aged 70+ years who were independent in activities of daily living, without cognitive impairment, progressive neurological disease or any other unstable or acute medical condition precluding exercise.
MAIN OUTCOME MEASURES


cost-effectiveness was measured as the incremental cost per fall and per injurious fall prevented. Cost-utility was measured as the incremental cost per quality-adjusted life year (QALY) gained.
MAIN RESULTS


the total average cost per patient for programme delivery and care resource cost was $8,321 (standard deviation [SD] 18,958) for intervention participants and $6,829 (SD 15,019) for control participants. The incremental cost per fall prevented was $4,785 and per injurious fall prevented was $6,585. The incremental cost per QALY gained was $58,039 (EQ5D-5L) and $110,698 (AQoL-6D).
CONCLUSION


this evaluation found that StandingTall has the potential to be cost-effective in specific subpopulations of older people, but not necessarily the whole older population.
TRIAL REGISTRATION


ACTRN12615000138583.",2022,"The incremental cost per QALY gained was $58,039 (EQ5D-5L) and $110,698 (AQoL-6D).
","['community-dwelling older people', 'people aged 70\xa0years and over', 'older community-dwelling people in Sydney, Australia', 'five hundred and three individuals aged 70+ years who were independent in activities of daily living, without cognitive impairment, progressive neurological disease or any other unstable or acute medical condition precluding exercise', 'older people']","['e-Health StandingTall balance exercise programme', 'e-Health balance exercise programme']","['falls and injurious falls', 'incremental cost per fall', 'cost-effectiveness', 'Cost-utility', 'total average cost per patient for programme delivery and care resource cost', 'incremental cost per fall and per injurious fall prevented']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]",503.0,0.0662424,"The incremental cost per QALY gained was $58,039 (EQ5D-5L) and $110,698 (AQoL-6D).
","[{'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Ambrens', 'Affiliation': 'School of Health, Medicine and Applied Science, Appleton Institute, CQUniversity, Melbourne, VIC, Australia.'}, {'ForeName': 'Kimberley S', 'Initials': 'KS', 'LastName': 'van Schooten', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Newtown, NSW, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jacqueline C T', 'Initials': 'JCT', 'LastName': 'Close', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'G A Rixt', 'Initials': 'GAR', 'LastName': 'Zijlstra', 'Affiliation': 'Care and Public Health Research Institute, Department of Health Services Research, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Valenzuela', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Medicine and Health Sciences, The University of Sydney, Sydney NSW 2141, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Appleton Institute, CQUniversity, Rockhampton, QLD, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chow', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'McInerney', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Miles', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Woodbury', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Delbaere', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Randwick, NSW, Australia.'}]",Age and ageing,['10.1093/ageing/afac130']
1386,35679047,Effect of Point-of-Care Testing for Respiratory Pathogens on Antibiotic Use in Children: A Randomized Clinical Trial.,"Importance


Limited data are available on the clinical impact of multiplex polymerase chain reaction (PCR) point-of-care testing for respiratory pathogens in acutely ill children.
Objective


To evaluate the effect of multiplex PCR point-of-care testing for respiratory pathogens on antibiotic use in acutely ill children.
Design, Setting, and Participants


This unblinded, randomized clinical trial was conducted from May 6, 2019, through March 12, 2020. The participants were followed up until hospitalization or discharge from the emergency department (ED) for primary outcome. The study was conducted at the pediatric ED of Oulu University Hospital, Finland. Eligible study participants were children aged 0 to 17 years with fever and/or any respiratory signs or symptoms. Children with underlying medical conditions were included. The statistical analyses were performed between August 11, 2020, and September 14, 2021.
Interventions


The participants were randomly assigned in a 2:1 ratio either to undergo multiplex PCR point-of-care testing (18 respiratory viruses and 3 bacteria with results ready within 70 minutes) upon arrival at the ED or to receive routine care.
Main Outcomes and Measures


The primary outcome was the proportion of children receiving antibiotic therapy. The secondary outcomes were the numbers of diagnostic tests and radiographic imaging procedures performed and costs.
Results


A total of 1417 children were assessed for eligibility. After exclusions, 1243 children (692 boys [56%]) were randomly allocated to either the intervention (829 children) or control (414 children) group. The mean (SD) age of the participants was 3.0 (3.6) years in the intervention group (median [IQR], 1.7 [0.4-4.1] years) and 3.0 (3.5) years (median [IQR], 1.9 [0.4-4.1] years) in the control group. Multiplex PCR point-of-care testing for respiratory pathogens did not reduce the overall prescribing of antibiotics in the emergency department (226 children [27.3%] in the intervention group vs 118 children [28.5%] in the control group; risk ratio, 0.96; 95% CI, 0.79-1.16). Targeted antibiotic therapy was started in 12 children (1.4%) tested with point-of-care multiplex PCR and 2 children (0.5%) in the control group (risk ratio, 3.0; 95% CI, 0.76-11.9). The numbers of diagnostic tests did not differ between the groups, nor did the costs.
Conclusions and Relevance


In this randomized clinical trial, point-of-care testing for respiratory pathogens did not reduce the use of antibiotics at the pediatric ED. Testing for respiratory pathogens appears to have a limited impact on clinical decision-making for acutely ill children.
Trial Registration


ClinicalTrials.gov Identifier: NCT03932942.",2022,"Multiplex PCR point-of-care testing for respiratory pathogens did not reduce the overall prescribing of antibiotics in the emergency department (226 children [27.3%] in the intervention group vs 118 children [28.5%] in the control group; risk ratio, 0.96; 95% CI, 0.79-1.16).","['Children', 'pediatric ED of Oulu University Hospital, Finland', 'Eligible study participants were children aged 0 to 17 years with fever and/or any respiratory signs or symptoms', 'Children with underlying medical conditions', 'acutely ill children', '1417 children', '1243 children (692 boys [56%]) were randomly allocated to either the intervention (829 children) or control (414 children) group', 'May 6, 2019, through March 12, 2020']","['multiplex PCR point-of-care testing', 'Point-of-Care Testing', 'multiplex polymerase chain reaction (PCR) point-of-care testing', 'multiplex PCR point-of-care testing (18 respiratory viruses and 3 bacteria with results ready within 70 minutes) upon arrival at the ED or to receive routine care']","['proportion of children receiving antibiotic therapy', 'numbers of diagnostic tests', 'overall prescribing of antibiotics', 'numbers of diagnostic tests and radiographic imaging procedures performed and costs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C3179032', 'cui_str': 'Multiplex PCR'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0597404', 'cui_str': 'Respiratory viruses'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1962945', 'cui_str': 'Radiographic imaging procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1417.0,0.308105,"Multiplex PCR point-of-care testing for respiratory pathogens did not reduce the overall prescribing of antibiotics in the emergency department (226 children [27.3%] in the intervention group vs 118 children [28.5%] in the control group; risk ratio, 0.96; 95% CI, 0.79-1.16).","[{'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Mattila', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Paalanne', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Honkila', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Pokka', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Tapiainen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.16162']
1387,35679043,Cost-effectiveness of Implementing Smoking Cessation Interventions for Patients With Cancer.,"Importance


Guidelines recommend cancer care clinicians offer smoking cessation treatment. Cost analyses will help stakeholders understand and plan for implementation of cessation programs.
Objective


To estimate the incremental cost per quit (ICQ) of adopting an intensive smoking cessation intervention among patients undergoing treatment at cancer care clinics, from a clinic perspective.
Design, Setting, and Participants


This economic evaluation, a secondary analysis of the Smokefree Support Study (conducted 2013-2018; completed 2021), used microcosting methods and sensitivity analyses to estimate the ICQ of the interventions. Participants included patients undergoing treatment for a broad range of solid tumors and lymphomas who reported current smoking and were receiving care at cancer care clinics within 2 academic medical centers.
Exposures


Intensive smoking cessation treatment (up to 11 counseling sessions with free medications), standard of care (up to 4 counseling sessions with medication advice), or usual care (referral to the state quitline).
Main Outcomes and Measures


Total costs, component-specific costs, and the ICQ of the intensive smoking cessation treatment relative to both standard of care (comparator in the parent randomized trial) and usual care (a common comparator outside this trial) were calculated. Overall and post hoc site-specific estimates are provided. Because usual care was not included in the parent trial, sensitivity analyses were conducted to assess how assumptions about usual care quit rates affected study outcomes (ie, base case [from a published smoking cessation trial among patients with thoracic cancer], best case, and conservative case scenarios).
Results


The per-patient costs of offering intensive smoking cessation treatment, standard of care, and usual care were $1989, $1482, and $0, respectively. For intensive treatment, the dominant costs were treatment (35%), staff supervision (26%), and patient enrollment (24%). Relative to standard of care, intensive treatment had an overall ICQ of $3906, and one site had an ICQ of $2892. Relative to usual care, intensive treatment had an ICQ of $9866 overall (base case), although at one site, the ICQ was $5408 (base case) and $3786 (best case).
Conclusions and Relevance


In this economic evaluation study, implementation of an intensive smoking cessation treatment intervention was moderately to highly cost-effective, depending on existing smoking cessation services in place.",2022,"In this economic evaluation study, implementation of an intensive smoking cessation treatment intervention was moderately to highly cost-effective, depending on existing smoking cessation services in place.","['Participants included patients undergoing treatment for a broad range of solid tumors and lymphomas who reported current smoking and were receiving care at cancer care clinics within 2 academic medical centers', 'patients undergoing treatment at cancer care clinics, from a clinic perspective', 'patients with thoracic cancer', 'Patients With Cancer']","['Implementing Smoking Cessation Interventions', 'Exposures\n\n\nIntensive smoking cessation treatment (up to 11 counseling sessions with free medications), standard of care (up to 4 counseling sessions with medication advice), or usual care (referral to the state quitline', 'incremental cost per quit (ICQ) of adopting an intensive smoking cessation intervention']","['Cost-effectiveness', 'Measures\n\n\nTotal costs, component-specific costs, and the ICQ of the intensive smoking cessation treatment relative to both standard of care (comparator', 'per-patient costs of offering intensive smoking cessation treatment, standard of care, and usual care']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0153661', 'cui_str': 'Malignant neoplasm of thorax'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]",,0.0471287,"In this economic evaluation study, implementation of an intensive smoking cessation treatment intervention was moderately to highly cost-effective, depending on existing smoking cessation services in place.","[{'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'MGH Biostatistics Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Friedman', 'Affiliation': 'Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rabin', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ostroff', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.16362']
1388,35680254,Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skills (YES) programme.,"INTRODUCTION


Adolescence is a challenging period for young people with type 1 diabetes, associated with worsening glycaemia and care disengagement. Educational interventions in this period tend to focus on diabetes-specific skills, with less emphasis on the psychosocial challenges associated with diabetes experienced by young people. To address this limitation, we codesigned with young people a psychosocially modelled programme of diabetes education, named 'Youth Empowerment Skills' (YES). The programme aims to facilitate a positive adaptation to life with diabetes and engagement with diabetes care through peer-based learning, immersive simulations and support from an outreach youth worker. Here, we present a protocol for a feasibility study of the YES programme.
METHODS AND ANALYSIS


The study was designed following the Medical Research Council Complex Intervention Evaluation Framework to: test the feasibility (acceptance, implementability, recruitment and completion) of the YES programme; and estimate its efficacy in relation to metabolic and psychosocial outcomes. The study will take place in diabetes centres serving socioculturally diverse populations. We will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Fifty young people with type 1 diabetes (aged 14-19 years) will be randomly allocated to either the YES intervention or a waiting-list control. Randomisation acceptability will be assessed with provision for a preference allocation. Outcomes will be evaluated at 6 months, at which point the waiting list participants will be exposed to the YES programme with further follow-up to 12 months. A simultaneous process evaluation will use a mixed-methods approach collecting qualitative and quantitative data. Study findings will be used to optimise the intervention components, outcome measures and recruitment methods to inform a subsequent definitive trial.
ETHICS AND DISSEMINATION


The protocol has ethical approval from the UK Health Research Authority (approval IRAS project ID: 279877). Findings will be disseminated in multiple formats for lay and professional audiences.
PROTOCOL DATE AND VERSION


7 April 2021, V.1.1.
TRIAL REGISTRATION NUMBER


NCT04670198.",2022,Fifty young people with type 1 diabetes (aged 14-19 years) will be randomly allocated to either the YES intervention or a waiting-list control.,"['young people with type 1 diabetes', ""young people a psychosocially modelled programme of diabetes education, named 'Youth Empowerment Skills' (YES"", '7 April 2021, V.1.1', 'Fifty young people with type 1 diabetes (aged 14-19 years', 'diabetes centres serving socioculturally diverse populations']","['diabetes care through peer-based learning, immersive simulations and support from an outreach youth worker', 'psychosocially modelled diabetes education programme', 'YES intervention or a waiting-list control']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0605853,Fifty young people with type 1 diabetes (aged 14-19 years) will be randomly allocated to either the YES intervention or a waiting-list control.,"[{'ForeName': 'Dulmini', 'Initials': 'D', 'LastName': 'Kariyawasam', 'Affiliation': ""Department of Diabetes and Endocrinology, Guy's and St.Thomas 'NHS foundation Trust, London, UK.""}, {'ForeName': 'Tayana', 'Initials': 'T', 'LastName': 'Soukup', 'Affiliation': ""Health Service and Population Research Department, King's College London, London, UK tayana.soukup@kcl.ac.uk.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Parsons', 'Affiliation': ""Division of Care Long-term Conditions, King's College London Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, London, UK.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Sevdalis', 'Affiliation': ""Health Service and Population Research Department, King's College London, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baldellou Lopez', 'Affiliation': ""Health Service and Population Research Department, King's College London, London, UK.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Forde', 'Affiliation': ""Division of Care Long-term Conditions, King's College London Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, London, UK.""}, {'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Health Service and Population Research Department, King's College London, London, UK.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': ""Department of Diabetes and Endocrinology, Guy's and St.Thomas 'NHS foundation Trust, London, UK.""}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Ford-Adams', 'Affiliation': ""Paediatric Diabetes Department, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Nardos', 'Initials': 'N', 'LastName': 'Yemane', 'Affiliation': ""Department of Diabetes and Endocrinology, Guy's and St.Thomas 'NHS foundation Trust, London, UK.""}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Pender', 'Affiliation': ""Department of Diabetes and Endocrinology, Guy's and St.Thomas 'NHS foundation Trust, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Department of Diabetes and Endocrinology, Guy's and St.Thomas 'NHS foundation Trust, London, UK.""}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Murrells', 'Affiliation': ""National Nursing Research Unit, King's College London, London, UK.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Silverstien', 'Affiliation': ""Division of Care Long-term Conditions, King's College London Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, London, UK.""}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': ""Division of Care Long-term Conditions, King's College London Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, London, UK.""}]",BMJ open,['10.1136/bmjopen-2022-062971']
1389,35680252,"Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol.","INTRODUCTION


Chronic, non-cancer pain impacts approximately 50 million adults in the USA (20%), approximately 25% of whom receive chronic prescription opioids for pain despite limited empirical efficacy data and strong dose-related risk for opioid use disorder and opioid overdose. Also despite lack of efficacy data, there are many reports of people using cannabis products to manage chronic pain and replace or reduce chronic opioids. Here we describe the protocol for a randomised trial of the effect of cannabis, when added to a behavioural pain management and prescription opioid taper support programme, on opioid utilisation, pain intensity and pain interference.
METHODS


This is a pragmatic, single-blind, randomised, wait-list controlled trial that aims to enrol 250 adults taking prescription opioids at stable doses of ≥25 morphine milligram equivalents per day for chronic non-cancer pain who express interest in using cannabis to reduce their pain, their opioid dose or both. All participants will be offered a weekly, 24-session Prescription Opioid Taper Support group behavioural pain management intervention. Participants will be randomly assigned in 1:1 ratio to use cannabis products, primarily from commercial cannabis dispensaries or to abstain from cannabis use for 6 months. Coprimary outcomes are change in prescription monitoring programme-verified opioid dose and change in Pain, Enjoyment, General Activity scale scores. Secondary outcomes include quality of life, depression, anxiety, self-reported opioid dose and opioid and cannabis use disorder symptoms. All other outcomes will be exploratory. We will record adverse events.
ETHICS AND DISSEMINATION


This study has ethical approval by the Massachusetts General Brigham Institutional Review Board (#2021P000871). Results will be published in peer-reviewed journals and presented at national conferences.
TRIAL REGISTRATION NUMBER


NCT04827992.",2022,"Coprimary outcomes are change in prescription monitoring programme-verified opioid dose and change in Pain, Enjoyment, General Activity scale scores.","['enrol 250 adults taking prescription opioids at stable doses of ≥25 morphine milligram equivalents per day for chronic non-cancer pain who express interest in using cannabis to reduce their pain, their opioid dose or both', 'adults with chronic non-cancer pain']","['24-session Prescription Opioid Taper Support group behavioural pain management intervention', 'cannabis products, primarily from commercial cannabis dispensaries or to abstain from cannabis use for 6\u2009months']","['opioid utilisation, pain intensity and pain interference', 'change in prescription monitoring programme-verified opioid dose and change in Pain, Enjoyment, General Activity scale scores', 'quality of life, depression, anxiety, self-reported opioid dose and opioid and cannabis use disorder symptoms']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505167', 'cui_str': 'Prescription drug monitoring program'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441655', 'cui_str': 'Activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.201928,"Coprimary outcomes are change in prescription monitoring programme-verified opioid dose and change in Pain, Enjoyment, General Activity scale scores.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Jashinski', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Grossman', 'Affiliation': 'Department of Medicine, Cambridge Health Alliance, Somerville, Massachusetts, USA.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Quaye', 'Affiliation': 'Department of Anesthesiology, MaineHealth, Portland, Maine, USA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jodi M', 'Initials': 'JM', 'LastName': 'Gilman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA jgilman1@mgh.harvard.edu.'}]",BMJ open,['10.1136/bmjopen-2022-064457']
1390,35680197,Clinical Outcomes in Patients With ST-Segment Elevation MI and No Standard Modifiable Cardiovascular Risk Factors.,"BACKGROUND


The author recently reported ∼50% excess early mortality in patients with first-presentation ST-segment elevation myocardial infarction (STEMI) without standard modifiable cardiovascular risk factors (SMuRFs); the cause of this is not clear.
OBJECTIVES


The aim of this study was to examine differences in infarct characteristics and clinical outcomes in patients with versus without SMuRFs (dyslipidemia, hypertension, diabetes mellitus, and smoking).
METHODS


Individual-level data were pooled from 10 randomized percutaneous intervention (PCI) trials in which infarct size was measured within 1 month by either cardiac magnetic resonance or technetium-99m sestamibi single-photon emission computed tomography imaging. First-presentation STEMI was classified into 2 groups according to the presence or absence of at least 1 SMuRF.
RESULTS


Among 2,862 patients, 524 (18.3%) were SMuRF-less. After adjusting for study effect, SMuRF-less patients had more frequent poor pre-PCI flow Thrombolysis In Myocardial Infarction 0/1 compared with patients with at least 1 SMuRF (72.0% vs 64.1%; OR: 1.35; 95% CI: 1.08-1.70). There were no independent associations between the presence or absence of SMuRFs at baseline and infarct size (estimate = -0.35; 95% CI: -1.93 to 1.23), left ventricular ejection fraction (estimate = -0.06; 95% CI: -1.33 to 1.20), or mortality at 30 days (HR: 0.46; 95% CI: 0.19-1.07) and 1 year (HR: 0.74; 95% CI: 0.43-1.29).
CONCLUSIONS


First-presentation STEMI patients with no identifiable baseline SMuRFs had a higher risk of Thrombolysis In Myocardial Infarction flow grade 0/1 pre-PCI. However, after adjustment, there were no significant associations between SMuRF-less status and infarct size, left ventricle ejection fraction, or mortality.",2022,"After adjusting for study effect, SMuRF-less patients had more frequent poor pre-PCI flow Thrombolysis","['patients with first-presentation ST-segment elevation myocardial infarction (STEMI) without standard modifiable cardiovascular risk factors (SMuRFs', 'patients with versus without SMuRFs (dyslipidemia, hypertension, diabetes mellitus, and smoking', 'Individual-level data were pooled from 10 randomized', '2,862 patients, 524 (18.3%) were SMuRF-less', 'Patients With ST-Segment Elevation MI and No Standard Modifiable Cardiovascular Risk Factors']","['percutaneous intervention (PCI', 'cardiac magnetic resonance or technetium-99m sestamibi single-photon emission computed tomography imaging']","['left ventricular ejection fraction', 'risk of Thrombolysis', 'presence or absence of SMuRFs at baseline and infarct size', 'frequent poor pre-PCI flow Thrombolysis', 'mortality', 'SMuRF-less status and infarct size, left ventricle ejection fraction, or mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439629', 'cui_str': 'First presentation'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0162680', 'cui_str': 'Technetium Tc 99m Sestamibi'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",2862.0,0.141239,"After adjusting for study effect, SMuRF-less patients had more frequent poor pre-PCI flow Thrombolysis","[{'ForeName': 'Gemma A', 'Initials': 'GA', 'LastName': 'Figtree', 'Affiliation': 'Kolling Research Institute, University of Sydney, Sydney, Australia; Imaging and Phenotyping Laboratory, Charles Perkins Centre and Faculty of Medicine and Health, University of Sydney, Sydney, Australia. Electronic address: gemma.figtree@sydney.edu.au.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, New York, New York, USA; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kozor', 'Affiliation': 'Kolling Research Institute, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Vernon', 'Affiliation': 'Kolling Research Institute, University of Sydney, Sydney, Australia; Imaging and Phenotyping Laboratory, Charles Perkins Centre and Faculty of Medicine and Health, University of Sydney, Sydney, Australia. Electronic address: https://twitter.com/steve_vern.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Grieve', 'Affiliation': 'Imaging and Phenotyping Laboratory, Charles Perkins Centre and Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jawad', 'Initials': 'J', 'LastName': 'Mazhar', 'Affiliation': 'Kolling Research Institute, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Duke University Hospital, Durham, North Carolina, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Harry P', 'Initials': 'HP', 'LastName': 'Selker', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Division of Cardiology, Duke University Hospital, Durham, North Carolina, USA.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Clinical Trials Center, New York, New York, USA.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Karmpaliotis', 'Affiliation': 'Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey, USA.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'University Heart Center Lübeck and the German Center for Cardiovascular Research, Lübeck, Germany.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology, Duke University Hospital, Durham, North Carolina, USA.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, New York, New York, USA; Division of Cardiovascular Medicine, University of California-San Diego, San Diego, California, USA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, New York, New York, USA; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: https://twitter.com/GreggWStone.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': 'Clinical Trials Center, New York, New York, USA; Division of Cardiology, Memorial Sloan Kettering Cancer Center and Weill-Cornell College of Medicine, New York, New York, USA. Electronic address: https://twitter.com/IKosmidou.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2022.03.036']
1391,35680195,Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.,"BACKGROUND


Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year.
OBJECTIVES


This study reports the final 2-year results of the randomized Onyx ONE trial.
METHODS


The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y 12  inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years.
RESULTS


A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54).
CONCLUSIONS


Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).",2022,"The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year.","['1,003 patients', 'and 993 patients to DCS', 'High Bleeding Risk Patients', 'High-Bleeding Risk Patients [Onyx ONE', 'High-Bleeding Risk Patients) trial randomly assigned HBR patients']","['ZES or DCS', 'BioFreedom polymer-free biolimus A9-coated stents (DCS', 'DAPT', 'SAPT (either aspirin', 'Antiplatelet Therapy (DAPT', 'zotarolimus-eluting stents (ZES', 'ZES', 'dual antiplatelet therapy (DAPT', 'Polymer-Based Versus Polymer-Free Stents']","['composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1700035', 'cui_str': 'Zotarolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C4310325', 'cui_str': 'Biolimus A9'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year'}]",1003.0,0.122088,"The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch.'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': 'Montefiore Medical Center, New York, New York, USA.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Clinique Hopitaliere Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Mount Sinai Medical Center, New York, New York, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Price', 'Affiliation': 'Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Abizaid', 'Affiliation': 'Instituto do Coracao, São Paulo, Brazil.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Simon', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Worthley', 'Affiliation': 'GenesisCare Cardiology, Alexandria, Australia.'}, {'ForeName': 'Azfar', 'Initials': 'A', 'LastName': 'Zaman', 'Affiliation': 'Freeman Hospital, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hudec', 'Affiliation': 'Stredoslovensky Ustav Srdcovych a Cievnych Chorob, Banska Bystrica, Slovakia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Poliacikova', 'Affiliation': 'Stredoslovensky Ustav Srdcovych a Cievnych Chorob, Banska Bystrica, Slovakia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Kahar Bin Abdul Ghapar', 'Affiliation': 'Hospital Serdang, Kajang, Malaysia.'}, {'ForeName': 'Kamaraj', 'Initials': 'K', 'LastName': 'Selvaraj', 'Affiliation': 'Hospital Serdang, Kajang, Malaysia.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Petrov', 'Affiliation': 'Acibadem City Clinic, Sofia, Bulgaria.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mylotte', 'Affiliation': 'Galway University Hospitals, Galway, Ireland.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Pinar', 'Affiliation': 'Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Spain.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Paz Institute for Health Research, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Fabbiocchi', 'Affiliation': 'Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Sanjeevan', 'Initials': 'S', 'LastName': 'Pasupati', 'Affiliation': 'Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tie', 'Affiliation': ""St Andrew's Hospital, Adelaide, Australia.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wlodarczak', 'Affiliation': 'Miedziowe Centrum Zdrowia, Lubin, Poland.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Steven O', 'Initials': 'SO', 'LastName': 'Marx', 'Affiliation': 'Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'St. Francis Hospital and Heart Center, Roslyn, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Parke', 'Affiliation': 'Medtronic, Santa Rosa, California, USA.'}, {'ForeName': 'Te-Hsin', 'Initials': 'TH', 'LastName': 'Lung', 'Affiliation': 'Medtronic, Santa Rosa, California, USA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York, USA; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2022.04.010']
1392,35680813,[The Treatment of Newly Diagnosed Primary Immune Thrombocytopenia by Recombinant Human Thrombopoietin Combined with Glucocorticoid].,"OBJECTIVE


To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) combined with glucocorticoid in treatment of newly diagnosed adult primary immune thrombocytopenia (ITP).
METHODS


Eleven male and 23 female patients with the diagnosis of primary ITP in our hospital from November 2018 to October 2019 were enrolled and randomly divided into test group (17 cases) and control group (17 cases), the median age was 52 years old (range: 20-76 years old). The patients in test group were treated with rhTPO 300 IU/(kg·d) combined with glucocorticoid , while the patients in control group were treated with rhTPO (15 000 IU/d) combined with glucocorticoid. Platelet count, platelet increase, as well as the overall response rate were compared. At the same time, the drug tolerance and any adverse drug reactions were observed.
RESULTS


The platelet counts and platelet increase of the patients in the test group were significantly higher than those in control group (P<0.05). There was no significant difference in platelet counts and platelet increase between the patients in the test group and control group at day 3, 7 after treatment. There was no significant difference in overall response rates and complete response rates at day 7, 14 between the two groups either. In test group, there were 13 cases received platelet transfusion, while 12 cases in control group. The muscle aches occurred in one patient, and mild aminotransferase increased in another patient in test group which was self-recovery without treatment.
CONCLUSION


RhTPO 300 U/(kg·d) combined with glucocorticoid could rapidly increase the platelet count with a low incidence of tolerable adverse events compared with conventional dose rhTPO with glucocorticoid.",2022,"There was no significant difference in overall response rates and complete response rates at day 7, 14 between the two groups either.","['Eleven male and 23 female patients with the diagnosis of primary ITP in our hospital from November 2018 to October 2019 were enrolled and randomly divided into test group (17 cases) and control group (17 cases), the median age was 52 years old (range: 20-76 years old', 'newly diagnosed adult primary immune thrombocytopenia (ITP']","['glucocorticoid', 'RhTPO 300', 'Recombinant Human Thrombopoietin Combined with Glucocorticoid', 'U/(kg·d', 'recombinant human thrombopoietin (rhTPO) combined with glucocorticoid', 'rhTPO 300 IU/(kg·d) combined with glucocorticoid', 'rhTPO']","['Platelet count, platelet increase', 'overall response rate', 'overall response rates and complete response rates', 'platelet count', 'platelet counts and platelet increase', 'mild aminotransferase', 'muscle aches', 'drug tolerance and any adverse drug reactions']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0857460', 'cui_str': 'Platelet count above reference range'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",11.0,0.0544333,"There was no significant difference in overall response rates and complete response rates at day 7, 14 between the two groups either.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China.'}, {'ForeName': 'Li-Yuan', 'Initials': 'LY', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China.'}, {'ForeName': 'Zhen-Zhen', 'Initials': 'ZZ', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China.'}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China,E-mail: ylhbsjz@163.com.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China.'}]",Zhongguo shi yan xue ye xue za zhi,['10.19746/j.cnki.issn.1009-2137.2022.03.027']
1393,35681162,Patients' and clinicians' experiences with stratified exercise therapy in knee osteoarthritis: a qualitative study.,"BACKGROUND


We have developed a model of stratified exercise therapy that distinguishes three knee osteoarthritis (OA) subgroups ('high muscle strength subgroup', 'low muscle strength subgroup', 'obesity subgroup'), which are provided subgroup-specific exercise therapy (supplemented by a dietary intervention for the 'obesity subgroup'). In a large clinical trial, this intervention was found to be no more effective than usual exercise therapy. The present qualitative study aimed to explore experiences from users of this intervention, in order to identify possible improvements.
METHODS


Qualitative research design embedded within a cluster randomized controlled trial in a primary care setting. A random sample from the experimental arm (i.e., 15 patients, 11 physiotherapists and 5 dieticians) was interviewed on their experiences with receiving or applying the intervention. Qualitative data from these semi-structured interviews were thematically analysed.
RESULTS


We identified four themes: one theme regarding the positive experiences with the intervention and three themes regarding perceived barriers. Although users from all 3 perspectives (patients, physiotherapists and dieticians) generally perceived the intervention as having added value, we also identified several barriers, especially for the 'obesity subgroup'. In this 'obesity subgroup', physiotherapists perceived obesity as difficult to address, dieticians reported that more consultations are needed to reach sustainable weight loss and both physiotherapists and dieticians reported a lack of interprofessional collaboration. In the 'high muscle strength subgroup', the low number of supervised sessions was perceived as a barrier by some patients and physiotherapists, but as a facilitator by others. A final theme addressed barriers to knee OA treatment in general, with lack of motivation as the most prominent of these.
CONCLUSION


Our qualitative study revealed a number of barriers to effective application of the stratified exercise therapy, especially for the 'obesity subgroup'. Based on these barriers, the intervention and its implementation could possibly be improved. Moreover, these barriers are likely to account at least partly for the lack of superiority over usual exercise therapy.
TRIAL REGISTRATION


The Netherlands National Trial Register (NTR): NL7463 (date of registration: 8 January 2019).",2022,"Although users from all 3 perspectives (patients, physiotherapists and dieticians) generally perceived the intervention as having added value, we also identified several barriers, especially for the 'obesity subgroup'.","[""distinguishes three knee osteoarthritis (OA) subgroups ('high muscle strength subgroup', 'low muscle strength subgroup', 'obesity subgroup"", 'knee osteoarthritis', '15 patients, 11 physiotherapists and 5 dieticians) was interviewed on their experiences with receiving or applying the intervention']","['specific exercise therapy', 'stratified exercise therapy']",[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}]",[],,0.0271321,"Although users from all 3 perspectives (patients, physiotherapists and dieticians) generally perceived the intervention as having added value, we also identified several barriers, especially for the 'obesity subgroup'.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Knoop', 'Affiliation': 'Vrije Universiteit Amsterdam, Department of Health Sciences, Amsterdam, De Boelelaan 1105, Amsterdam, 1081 HV, Netherlands. j.knoop@vu.nl.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'de Joode', 'Affiliation': 'Vrije Universiteit Amsterdam, Department of Health Sciences, Amsterdam, De Boelelaan 1105, Amsterdam, 1081 HV, Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brandt', 'Affiliation': 'Vrije Universiteit Amsterdam, Department of Health Sciences, Amsterdam, De Boelelaan 1105, Amsterdam, 1081 HV, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Amsterdam UMC, Location VUmc, Department of Rehabilitation Medicine, Amsterdam, Netherlands.'}, {'ForeName': 'R W J G', 'Initials': 'RWJG', 'LastName': 'Ostelo', 'Affiliation': 'Vrije Universiteit Amsterdam, Department of Health Sciences, Amsterdam, De Boelelaan 1105, Amsterdam, 1081 HV, Netherlands.'}]",BMC musculoskeletal disorders,['10.1186/s12891-022-05496-2']
1394,35681155,Ventilator-associated pneumonia prevention in the Intensive care unit using Postpyloric tube feeding in China (VIP study): study protocol for a randomized controlled trial.,"BACKGROUND


Ventilator-associated pneumonia is a challenge in critical care and is associated with high mortality and morbidity. Although some consensuses on preventing ventilator-associated pneumonia are reached, it is still somewhat controversial. Meta-analysis has shown that postpyloric tube feeding may reduce the incidences of ventilator-associated pneumonia, which still desires high-quality evidence. This trial aims to evaluate the efficacy and safety profiles of postpyloric tube feeding versus gastric tube feeding.
METHODS/DESIGN


In this multicenter, open-label, randomized controlled trial, we will recruit 924 subjects expected to receive mechanical ventilation for no less than 48 h. Subjects on mechanical ventilation will be randomized (1:1) to receive postpyloric or gastric tube feeding and routine preventive measures simultaneously. The primary outcome is the proportion of patients with at least one ventilator-associated pneumonia episode. Adverse events and serious adverse events will be observed closely.
DISCUSSION


The VIP study is a large-sample-sized, multicenter, open-label, randomized, parallel-group, controlled trial of postpyloric tube feeding in China and is well-designed based on previous studies. The results of this trial may help to provide evidence-based recommendations for the prevention of ventilator-associated pneumonia.
TRIAL REGISTRATION


Chictr.org.cn ChiCTR2100051593 . Registered on 28 September 2021.",2022,"Meta-analysis has shown that postpyloric tube feeding may reduce the incidences of ventilator-associated pneumonia, which still desires high-quality evidence.",['924 subjects expected to receive mechanical ventilation for no less than 48 h. Subjects on mechanical ventilation'],"['postpyloric tube feeding versus gastric tube feeding', 'postpyloric or gastric tube feeding and routine preventive measures simultaneously']","['proportion of patients with at least one ventilator-associated pneumonia episode', 'Adverse events and serious adverse events']","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C0086337', 'cui_str': 'Gastric Feeding Tubes'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",924.0,0.172629,"Meta-analysis has shown that postpyloric tube feeding may reduce the incidences of ventilator-associated pneumonia, which still desires high-quality evidence.","[{'ForeName': 'Linhui', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""Department of Critical Care Medicine, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China.""}, {'ForeName': 'Kaiyi', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': ""Department of Critical Care Medicine, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China.""}, {'ForeName': 'Xiangwei', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Critical Care Medicine, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China.""}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China.""}, {'ForeName': 'Quanzhong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Surgical Intensive Care Unit, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China.""}, {'ForeName': 'Yumei', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': ""Department of Neurocritical Care Unit, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China.""}, {'ForeName': 'Yating', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ""Department of Oncology, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China.""}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Clinical Research Center, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China.""}, {'ForeName': 'Xinjuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Department of Clinical Research Center, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China.""}, {'ForeName': 'Chunbo', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Critical Care Medicine, Maoming People's Hospital, 101 Weimin Road, Maoming, 525000, Guangdong, China. gghccm@163.com.""}]",Trials,['10.1186/s13063-022-06407-5']
1395,35681130,teen Mental Health First Aid: 12-month outcomes from a cluster crossover randomized controlled trial evaluation of a universal program to help adolescents better support peers with a mental health problem.,"BACKGROUND


teen Mental Health First Aid (tMHFA) is a universal mental health literacy, stigma reduction, help-seeking, and suicide prevention program designed for adolescents in Years 10-12 of secondary school (16-18 years). tMHFA is delivered by trained instructors, in a regular classroom setting, to increase the knowledge, attitudes and behaviours that adolescents' require to better support peers with mental health problems or mental health crises.
METHODS


To explore the efficacy of tMHFA, a cluster crossover randomised controlled trial was conducted with Year 10 students in four schools in Victoria, Australia, using physical first aid training as the control intervention. Of the 1942 eligible students, 1,624 completed baseline and 894 completed follow-up surveys. Online surveys, administered one week before training and again 12-months later, included vignettes depicting peers John (depression and suicide risk) and Jeanie (social anxiety/phobia), measures of mental health first aid (quality of first aid intentions, confidence, first aid behaviours provided, and first aid behaviours received), mental health literacy (beliefs about adult help, help-seeking intentions), and stigma (social distance, weak-not-sick, dangerous/unpredictable, and would not tell anyone).
RESULTS


The primary outcome-quality of first aid intentions towards the John vignette-showed statistically significant group x time interactions, with tMHFA students reporting more helpful and less unhelpful first aid intentions, than PFA students did over time. Confidence in providing first aid also showed significant interactions. First aid behaviours-both those provided to a peer with a mental health problem and those received from a peer-showed null results. Ratings of both beliefs about adult help and help-seeking intentions were found to be significantly improved among tMHFA students at follow-up. A group x time interaction was found on one stigma scale (would not tell anyone).
CONCLUSIONS


This trial showed that, one year after training, tMHFA improves first aid intentions towards peers with depression and suicide risk, confidence in helping peers with mental health problems, willingness to tell someone and seek help from an adult or health professional if experiencing a mental health problem.
TRIAL REGISTRATION


This research was registered with Australia New Zealand Clinical Trials Registry: ACTRN12614000061639 .",2022,Ratings of both beliefs about adult help and help-seeking intentions were found to be significantly improved among tMHFA students at follow-up.,"['Year 10 students in four schools in Victoria, Australia, using physical first aid training as the control intervention', 'adolescents better support peers with a mental health problem', 'adolescents in Years 10-12 of secondary school (16-18\xa0years', '1942 eligible students, 1,624 completed baseline and 894 completed follow-up surveys']","['tMHFA', 'universal program', 'mental health literacy (beliefs about adult help, help-seeking intentions), and stigma (social distance, weak-not-sick, dangerous/unpredictable, and would not tell anyone']","['quality of first aid intentions towards the John vignette-showed statistically significant group x time interactions, with tMHFA students reporting more helpful and less unhelpful first aid intentions', 'vignettes depicting peers John (depression and suicide risk) and Jeanie (social anxiety/phobia), measures of mental health first aid (quality of first aid intentions, confidence, first aid behaviours', 'Ratings of both beliefs about adult help and help-seeking intentions', 'stigma scale']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441857', 'cui_str': 'Group X'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.11574,Ratings of both beliefs about adult help and help-seeking intentions were found to be significantly improved among tMHFA students at follow-up.,"[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hart', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health , University of Melbourne, Melbourne, Australia. lhart@unimelb.edu.au.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Morgan', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health , University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Alyssia', 'Initials': 'A', 'LastName': 'Rossetto', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health , University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Kelly', 'Affiliation': 'Mental Health First Aid Australia, Melbourne, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gregg', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health , University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Gross', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health , University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health , University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Anthony F', 'Initials': 'AF', 'LastName': 'Jorm', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health , University of Melbourne, Melbourne, Australia.'}]",BMC public health,['10.1186/s12889-022-13554-6']
1396,35681510,Analysis of Leukocyte Recruitment in Continuous Veno-Venous Hemofiltration with Regional Citrate vs. Systemic Heparin Anticoagulation.,"Acute kidney injury (AKI) is a frequent complication in critically ill patients. Supportive treatment of AKI patients is based on renal-replacement therapy, including continuous veno-venous hemofiltration (CVVH). To limit clotting events on extracorporeal surfaces, anticoagulants are administered, including systemic heparin and local citrate. The differential and comparative effects of these anticoagulants on leukocyte function in acute kidney injury patients are, so far, insufficiently understood. In this bio-add-on-study, AKI patients were randomized as part of a parallel-group trial to either systemic heparin or regional citrate anticoagulation. Patient samples were collected upon inclusion, prior to CVVH initiation at day 0, day 1, day 3 and day 5, following CVVH initiation, and one day after cessation of CVVH, then immediately analyzed. Flow cytometric assessment of surface-receptor molecules was conducted. Whole-blood-perfused human microfluidic chambers were used for the analysis of neutrophil rolling and adhesion. Acute kidney injury was associated with significant changes in the surface expression of CD182 and CD16 throughout CVVH treatment, independent of the anticoagulation regime. AKI furthermore abrogated selectin-induced slow leukocyte rolling and diminished chemokine-induced leukocyte arrest. Subgroup analyses of citrate vs. heparin treatment showed no significant differences between groups, independent of the duration of CVVH treatment. CD182 and CD16 expression remained low in both groups throughout CVVH therapy. These data confirm that AKI impairs selectin-mediated leukocyte slow rolling and chemokine-induced leukocyte arrest in vitro. Systemic heparin or local citrate anticoagulation have no differential effect on the leukocyte recruitment steps examined in this study.",2022,"Acute kidney injury was associated with significant changes in the surface expression of CD182 and CD16 throughout CVVH treatment, independent of the anticoagulation regime.","['Acute kidney injury (AKI', 'AKI patients', 'acute kidney injury patients', 'critically ill patients']","['Continuous Veno-Venous Hemofiltration with Regional Citrate vs. Systemic Heparin Anticoagulation', 'Systemic heparin or local citrate anticoagulation', 'systemic heparin or regional citrate anticoagulation', 'anticoagulants', 'citrate vs. heparin', 'continuous veno-venous hemofiltration (CVVH']","['duration of CVVH treatment', 'surface expression of CD182 and CD16', 'CD182 and CD16 expression', 'leukocyte function']","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0472684', 'cui_str': 'Continuous venovenous hemofiltration'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0472684', 'cui_str': 'Continuous venovenous hemofiltration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0108747', 'cui_str': 'Lymphocyte antigen CD16'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0766706,"Acute kidney injury was associated with significant changes in the surface expression of CD182 and CD16 throughout CVVH treatment, independent of the anticoagulation regime.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Margraf', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Therapy, University Hospital Münster, 48149 Münster, Germany.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Therapy, University Hospital Münster, 48149 Münster, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Küllmar', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Therapy, University Hospital Münster, 48149 Münster, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Therapy, University Hospital Münster, 48149 Münster, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rossaint', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Therapy, University Hospital Münster, 48149 Münster, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Therapy, University Hospital Münster, 48149 Münster, Germany.'}]",Cells,['10.3390/cells11111815']
1397,35661491,"""Efficacy of intensive bilateral Temporo-Parietal Continuous theta-burst Stimulation for Auditory VErbal hallucinations (TPC-SAVE) in schizophrenia: A randomized sham-controlled trial"" ☆ .","Transcranial magnetic stimulation (TMS) is a non-invasive tool that moderates specific brain regions to ameliorate auditory verbal hallucinations (AVH) in schizophrenia. Citing the critical involvement of temporoparietal cortex (TPC) in AVH, our study aimed to evaluate the effect of continuous theta burst stimulation (cTBS) targeting bilateral TPC in schizophrenia subjects with AVH, on a randomized rater blinded placebo control trial. 59 patients were randomly allocated to active and sham groups. They received 20 cTBS sessions (2 per day: first right TPC, then left TPC) 5 days a week for 2 weeks. PANSS (Positive and Negative Syndrome Scale), AVHRS (Auditory vocal hallucination rating scale), PSYRAT-AH (Psychiatric symptoms rating scale- Auditory hallucinations scale), CDSS (Calgary depression scale for schizophrenia), SCoRS (Schizophrenia cognition rating scale) and CGI-S (Clinical global impression-severity) were rated at baseline, immediately post 20th session and 2 weeks post-TBS. 50 patients (25-active, 25-sham) completed the study. Conducting an intention to treat analysis, we found a significant group*time effect for PANSS, AVHRS, PSYRAT-AH, CDSS, SCoRS, CGI-S but when controlled for confounding variables and multiple comparisons, only PANSS-PS (F=26.617, p < 0.001), PANSS-TOTAL (F=23.671, p < 0.001), AVHRS (F=17.779, p < 0.001), PSYRAT-AH (F=11.385, p < 0.001) and CGI-S (F=28.462, p < 0.001) retained significance. We conclude that cTBS over TPC is safe and has efficacy in treating AVH in schizophrenia. Limited sample size and lack of integrity assessment for blinding in the study participants are major limitations of the study.",2022,"Conducting an intention to treat analysis, we found a significant group*time effect for PANSS, AVHRS, PSYRAT-AH, CDSS, SCoRS, CGI-S but when controlled for confounding variables and multiple comparisons, only PANSS-PS (F=26.617, p < 0.001), PANSS-TOTAL (F=23.671, p < 0.001), AVHRS (F=17.779, p < 0.001), PSYRAT-AH (F=11.385, p < 0.001) and CGI-S (F=28.462, p < 0.001) retained significance.","['50 patients (25-active, 25-sham) completed the study', 'Auditory VErbal hallucinations (TPC-SAVE) in schizophrenia', '59 patients', 'schizophrenia subjects with AVH']","['continuous theta burst stimulation (cTBS', 'cTBS over TPC', 'intensive bilateral Temporo-Parietal Continuous theta-burst Stimulation', 'Transcranial magnetic stimulation (TMS', 'placebo']","['AVHRS', 'Psychiatric symptoms rating scale- Auditory hallucinations scale), CDSS (Calgary depression scale for schizophrenia), SCoRS (Schizophrenia cognition rating scale) and CGI-S (Clinical global impression-severity', 'PANSS (Positive and Negative Syndrome Scale), AVHRS (Auditory vocal hallucination rating scale), PSYRAT-AH ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}]",59.0,0.129597,"Conducting an intention to treat analysis, we found a significant group*time effect for PANSS, AVHRS, PSYRAT-AH, CDSS, SCoRS, CGI-S but when controlled for confounding variables and multiple comparisons, only PANSS-PS (F=26.617, p < 0.001), PANSS-TOTAL (F=23.671, p < 0.001), AVHRS (F=17.779, p < 0.001), PSYRAT-AH (F=11.385, p < 0.001) and CGI-S (F=28.462, p < 0.001) retained significance.","[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Tyagi', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand 248001, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Dhyani', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand 248001, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Khattri', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand 248001, India.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Tejan', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand 248001, India.'}, {'ForeName': 'Sai Krishna', 'Initials': 'SK', 'LastName': 'Tikka', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bibinagar, Telangana, India.'}, {'ForeName': 'Shobit', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, Uttarakhand 248001, India. Electronic address: shobit.garg@gmail.com.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2022.103176']
1398,35661445,Short-term effects of electronic cigarettes on cerebrovascular function: A time course study.,"NEW FINDINGS


What is the central question of this study? Acute exposure to electronic cigarettes (Ecigs) triggers abnormal vascular responses in systemic arteries; however, effects on cerebral vessels are poorly understood and time for recovery is not known. We hypothesized that exposure to cigarettes or Ecigs would trigger rapid (<4 h) impairment of the middle cerebral artery (MCA) but that this would resolve by 24 h. What is the main finding and its importance? Cigarettes and Ecigs caused similar degree and duration of MCA impairment. We find it takes ~72 hours after exposure for MCA function to return to normal. This suggests that Ecig use is likely to produce similar adverse vascular health outcomes to those seen with cigarette smoke.
ABSTRACT


Temporal influences of electronic cigarettes (Ecigs) on blood vessels are poorly understood. In this study, we evaluated a single episode of cigarette versus Ecig exposure on middle cerebral artery (MCA) reactivity and determined how long after the exposure MCA responses took to return to normal. We hypothesized that cigarette and Ecig exposure would induce rapid (<4 h) reduction in MCA endothelial function and would resolve within 24 h. Sprague-Dawley rats (4 months old) were exposed to either air (n = 5), traditional cigarettes (20 puffs, n = 16) or Ecigs (20-puff group, n = 16; or 60-puff group, n = 12). Thereafter, the cigarette and Ecig groups were randomly assigned for postexposure vessel myography testing on day 0 (D0, 1-4 h postexposure), day 1 (D1, 24-28 h postexposure), day 2 (D2, 48-52 h postexposure) and day 3 (72-76 h postexposure). The greatest effect on endothelium-dependent dilatation was observed within 24 h of exposure (∼50% decline between D0 and D1) for both cigarette and Ecig groups, and impairment persisted with all groups for up to 3 days. Changes in endothelium-independent dilatation responses were less severe (∼27%) and shorter lived (recovering by D2) compared with endothelium-dependent dilatation responses. Vasoconstriction in response to serotonin (5-HT) was similar to endothelium-independent dilatation, with greatest impairment (∼45% for all exposure groups) at D0-D1, returning to normal by D2. These data show that exposure to cigarettes and Ecigs triggers a similar level/duration of cerebrovascular dysfunction after a single exposure. The finding that Ecig (without nicotine) and cigarette (with nicotine) exposure produce the same effects suggesting that nicotine is not likely to be triggering MCA dysfunction, and that vaping (with/without nicotine) has potential to produce the same vascular harm and/or disease as smoking.",2022,"Vasoconstriction in response to serotonin (5-HT) was similar to EID, with greatest impairment (∼45% for all exposure groups) at D0-D1, and returning to normal by D2.",['Sprague-Dawley rats (4-month-old'],"['electronic cigarettes', 'serotonin (5-HT', 'Ecig (without nicotine) and cigarette exposure (with nicotine', 'cigarette versus Ecig exposure', 'electronic cigarettes (Ecigs']","['adverse vascular health outcomes', 'middle cerebral artery (MCA) reactivity', 'cerebrovascular function', 'degree and duration of MCA impairment', 'Changes in endothelial-independent-dilation (EID) responses', 'endothelial-dependent-dilation (EDD', 'MCA endothelial function']","[{'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]",,0.0481974,"Vasoconstriction in response to serotonin (5-HT) was similar to EID, with greatest impairment (∼45% for all exposure groups) at D0-D1, and returning to normal by D2.","[{'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Mills', 'Affiliation': 'Department of Physiology and Pharmacology, West Virginia University School of Medicine, Morgantown, West Virginia, USA.'}, {'ForeName': 'Duaa', 'Initials': 'D', 'LastName': 'Dakhlallah', 'Affiliation': 'Department of Microbiology, Immunology and Cell Biology, West Virginia University School of Medicine, Morgantown, West Virginia, USA.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Division of Exercise Physiology, West Virginia University School of Medicine, Morgantown, West Virginia, USA.'}, {'ForeName': 'Ally', 'Initials': 'A', 'LastName': 'Kirk', 'Affiliation': 'Alderson Broaddus University, West Virginia University School of Medicine, Morgantown, West Virginia, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Llavina', 'Affiliation': 'Center for Inhalation Toxicology, West Virginia University School of Medicine, Morgantown, West Virginia, USA.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Boyd', 'Affiliation': 'Center for Inhalation Toxicology, West Virginia University School of Medicine, Morgantown, West Virginia, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Chantler', 'Affiliation': 'Division of Exercise Physiology, West Virginia University School of Medicine, Morgantown, West Virginia, USA.'}, {'ForeName': 'I Mark', 'Initials': 'IM', 'LastName': 'Olfert', 'Affiliation': 'Department of Physiology and Pharmacology, West Virginia University School of Medicine, Morgantown, West Virginia, USA.'}]",Experimental physiology,['10.1113/EP090341']
1399,35661898,Patient perceptions of a community-based intervention designed to provide support post administration of anti-cancer systemic treatments: A qualitative evaluation.,"PURPOSE


This paper reports on patient participant experiences of a larger randomised controlled trial evaluating a shared-care pathway intervention designed to support outpatients at home during their first three cycles of systemic anti-cancer therapies delivered in two large tertiary hospitals in Sydney, Australia. This qualitative study explores the perspectives of patient participants who received the intervention, which involved targeted home visits by community nurses post treatment administration.
METHODS


A qualitative inductive thematic analysis was used to examine data from semi-structured interviews with patients who received the intervention.
RESULTS


Twenty-five patient participants were interviewed. We identified four themes: Stepping into the unknown; Impact of availability of health and social care support; Building confidence to manage self-care; Uncertainty, frailty and co-morbidities. Targeted support at home is seen to be effective and welcomed by patients as early stages of each treatment cycle can be extremely challenging, particularly for those who are elderly, frail or with co-morbidities, and for those with limited health and social support.
CONCLUSION


Regular contact with community nursing services can, at least for some patients, support the development of patient self-efficacy in managing aspects of their own care. Some patients are sufficiently confident to self-manage some treatment side effects by treatment cycle four.",2022,"Targeted support at home is seen to be effective and welcomed by patients as early stages of each treatment cycle can be extremely challenging, particularly for those who are elderly, frail or with co-morbidities, and for those with limited health and social support.
","['outpatients at home during their first three cycles of systemic anti-cancer therapies delivered in two large tertiary hospitals in Sydney, Australia', 'patient participants who received the intervention, which involved targeted home visits by community nurses post treatment administration', 'Twenty-five patient participants were interviewed']",['community-based intervention designed to provide support post administration of anti-cancer systemic treatments'],[],"[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0557521', 'cui_str': 'Community nurse'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],25.0,0.0596504,"Targeted support at home is seen to be effective and welcomed by patients as early stages of each treatment cycle can be extremely challenging, particularly for those who are elderly, frail or with co-morbidities, and for those with limited health and social support.
","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McKenzie', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, The University of Sydney, Australia. Electronic address: h.mckenzie@sydney.edu.au.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, The University of Sydney, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Acret', 'Affiliation': 'Cancer Care Research Unit, Faculty of Medicine and Health, The University of Sydney, Australia; The Daffodil Centre, The University of Sydney, a Joint Venture with Cancer Council NSW, Australia.'}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Boustany', 'Affiliation': 'Cancer Care Research Unit, Faculty of Medicine and Health, The University of Sydney, Australia; The Daffodil Centre, The University of Sydney, a Joint Venture with Cancer Council NSW, Australia; Sydney Local Health District, Australia.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Cancer Care Research Unit, Faculty of Medicine and Health, The University of Sydney, Australia; Nursing & Midwifery and Health Sciences, Faculty of Medicine, Notre Dame University, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Fethney', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, The University of Sydney, Australia.'}, {'ForeName': 'Judy M', 'Initials': 'JM', 'LastName': 'Simpson', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Australia.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'McLeod', 'Affiliation': 'Sydney District Nursing, Sydney Local Health District, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Willcock', 'Affiliation': 'MQ Health, Macquarie University Hospital, Primary Care, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Cook', 'Affiliation': 'Faculty of Medicine and Health, University of NSW, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'White', 'Affiliation': 'Cancer Care Research Unit, Faculty of Medicine and Health, The University of Sydney, Australia; The Daffodil Centre, The University of Sydney, a Joint Venture with Cancer Council NSW, Australia; Sydney Local Health District, Australia.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2022.102148']
1400,35662283,Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial.,"Chemotherapy combined with immunotherapy has improved the treatment of certain solid tumors, but effective regimens remain elusive for pancreatic ductal adenocarcinoma (PDAC). We conducted a randomized phase 2 trial evaluating the efficacy of nivolumab (nivo; anti-PD-1) and/or sotigalimab (sotiga; CD40 agonistic antibody) with gemcitabine/nab-paclitaxel (chemotherapy) in patients with first-line metastatic PDAC ( NCT03214250 ). In 105 patients analyzed for efficacy, the primary endpoint of 1-year overall survival (OS) was met for nivo/chemo (57.7%, P = 0.006 compared to historical 1-year OS of 35%, n = 34) but was not met for sotiga/chemo (48.1%, P = 0.062, n = 36) or sotiga/nivo/chemo (41.3%, P = 0.223, n = 35). Secondary endpoints were progression-free survival, objective response rate, disease control rate, duration of response and safety. Treatment-related adverse event rates were similar across arms. Multi-omic circulating and tumor biomarker analyses identified distinct immune signatures associated with survival for nivo/chemo and sotiga/chemo. Survival after nivo/chemo correlated with a less suppressive tumor microenvironment and higher numbers of activated, antigen-experienced circulating T cells at baseline. Survival after sotiga/chemo correlated with greater intratumoral CD4 T cell infiltration and circulating differentiated CD4 T cells and antigen-presenting cells. A patient subset benefitting from sotiga/nivo/chemo was not identified. Collectively, these analyses suggest potential treatment-specific correlates of efficacy and may enable biomarker-selected patient populations in subsequent PDAC chemoimmunotherapy trials.",2022,Survival after sotiga/chemo correlated with greater intratumoral CD4 T cell infiltration and circulating differentiated CD4 T cells and antigen-presenting cells.,"['first-line metastatic pancreatic cancer', 'patients with first-line metastatic PDAC ( NCT03214250 ']","['Chemotherapy combined with immunotherapy', 'Sotigalimab and/or nivolumab with chemotherapy', 'nivolumab (nivo; anti-PD-1) and/or sotigalimab (sotiga; CD40 agonistic antibody) with gemcitabine/nab-paclitaxel (chemotherapy']","['suppressive tumor microenvironment and higher numbers of activated, antigen-experienced circulating T cells', '1-year overall survival (OS', 'intratumoral CD4 T cell infiltration and circulating differentiated CD4 T cells and antigen-presenting cells', 'Survival', 'adverse event rates', 'progression-free survival, objective response rate, disease control rate, duration of response and safety']","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0054959', 'cui_str': 'Lymphocyte antigen CD40'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C2936626', 'cui_str': 'Tumor Microenvironment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.169037,Survival after sotiga/chemo correlated with greater intratumoral CD4 T cell infiltration and circulating differentiated CD4 T cells and antigen-presenting cells.,"[{'ForeName': 'Lacey J', 'Initials': 'LJ', 'LastName': 'Padrón', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA. lpadron@parkerici.org.'}, {'ForeName': 'Deena M', 'Initials': 'DM', 'LastName': 'Maurer', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': ""O'Hara"", 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wolff', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fisher', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Rahma', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Jaclyn P', 'Initials': 'JP', 'LastName': 'Lyman', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Cabanski', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Jia Xin', 'Initials': 'JX', 'LastName': 'Yu', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Pfeiffer', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Spasic', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Pier Federico', 'Initials': 'PF', 'LastName': 'Gherardini', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Joyson', 'Initials': 'J', 'LastName': 'Karakunnel', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Mick', 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Alanio', 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Katelyn T', 'Initials': 'KT', 'LastName': 'Byrne', 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Travis J', 'Initials': 'TJ', 'LastName': 'Hollmann', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jonni S', 'Initials': 'JS', 'LastName': 'Moore', 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Jones', 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tognetti', 'Affiliation': 'Biognosys AG, Schlieren, Switzerland.'}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Chen', 'Affiliation': 'Personalis, Inc., Menlo Park, CA, USA.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Apexigen, Inc., San Carlos, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Salvador', 'Affiliation': 'Bristol Myers Squibb, New York, NY, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Wherry', 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Dugan', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': ""O'Donnell-Tormey"", 'Affiliation': 'Cancer Research Institute, New York, NY, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Butterfield', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Hubbard-Lucey', 'Affiliation': 'Cancer Research Institute, New York, NY, USA.'}, {'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Ibrahim', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Fairchild', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bucktrout', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'LaVallee', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Vonderheide', 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA. rhv@upenn.edu.'}]",Nature medicine,['10.1038/s41591-022-01829-9']
1401,35658902,"""If somebody had told me I'd feel like I do now, I wouldn't have believed them…"" older adults' experiences of the BELL trial: a qualitative study.","OBJECTIVES


This study examined older adults' experiences of participating in the Ballistic Exercise of the Lower Limb (BELL) trial, involving 12-weeks of group-based hardstyle kettlebell training.
METHODS


In the BELL trial, 28 insufficiently active older adults (15 women, 13 men, 59-79 years) completed six weeks of face-to-face group training, and six weeks of home-based training. In-depth semi-structured interviews were audio recorded, transcribed, and inductively coded, with themes constructed from patterns of shared meaning.
RESULTS


Four higher-order themes were developed that reflect older adults' experiences participating in a group-exercise program of hardstyle kettlebell training. These included: (1) ""It's one of the best things we've done""-enjoying the physical and psychosocial benefits, (2) ""It's improved it tremendously!""-change in a long-term health condition, (3) ""It put me on a better course""-overcoming challenges, and (4) ""I wasn't just a number""-feeling part of a group/community.
DISCUSSION


Findings highlight the perceived physical and psychological benefits of older adults participating in hardstyle group kettlebell training, and the value attributed to being part of an age-matched community of like-minded people engaged in group exercise. Implications for program design and delivery, and future research, are discussed.",2022,I wasn't just a number,"['older adults', '28 insufficiently active older adults (15 women, 13 men, 59-79\xa0years', ""older adults' experiences of participating in the Ballistic Exercise of the Lower Limb (BELL) trial, involving 12-weeks of group-based hardstyle kettlebell training""]",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0443149', 'cui_str': 'Ballistic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],[],28.0,0.0218582,I wasn't just a number,"[{'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Meigh', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Bond Institute of Health & Sport, Gold Coast, QLD, 4226, Australia. nmeigh@bond.edu.au.'}, {'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Davidson', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Bond Institute of Health & Sport, Gold Coast, QLD, 4226, Australia.'}, {'ForeName': 'Justin W L', 'Initials': 'JWL', 'LastName': 'Keogh', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Bond Institute of Health & Sport, Gold Coast, QLD, 4226, Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Hing', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Bond Institute of Health & Sport, Gold Coast, QLD, 4226, Australia.'}]",BMC geriatrics,['10.1186/s12877-022-03174-5']
1402,35665994,A brief psychological intervention for chronic pain in primary care: Examining long-term effects from a pilot randomized clinical trial.,"BACKGROUND


Despite the existence of evidence-based psychological interventions for pain management, there are barriers that interfere with treatment engagement. A brief intervention integrated into primary care reduced barriers and showed promising benefits from pre- to post-intervention. However, it is unknown whether a brief intervention can provide long-term effects. The purpose of this study was to examine whether a brief psychological intervention offered benefits in pain severity, pain interference, pain catastrophizing, and depressive symptoms at 1- and 6-month follow-ups.
METHODS


The majority of participants who enrolled in a pilot randomized clinical trial of a 5-session psychological intervention for chronic pain in primary care completed the 1-month (n = 54; 90%) and 6-month follow-ups (n = 50; 83.3%). Participants completed measures of pain severity, pain interference, pain catastrophizing, and depressive symptoms.
RESULTS


From baseline to the 6-month follow-up, those in the intervention group had significantly better outcomes for pain severity (p = 0.01) and pain catastrophizing (p = 0.003) compared with the control group. There were no significant differences between the intervention and control groups for pain interference and depression. The percentage of patients in the intervention experiencing clinically significant improvement across all outcomes was higher than the control group.
CONCLUSIONS


Findings suggest that a brief psychological intervention for chronic pain in primary care may offer longer-term benefits similar to that of lengthier interventions. Future studies should examine this through a randomized clinical trial with a larger sample size.",2022,"RESULTS


From baseline to the 6-month follow-up, those in the intervention group had significantly better outcomes for pain severity (p= .01) and pain catastrophizing (p= .003) compared to the control group.",['Chronic Pain in Primary Care'],"['Psychological Intervention', 'psychological intervention', '5-session psychological intervention']","['pain severity, pain interference, pain catastrophizing, and depressive symptoms', 'pain interference and depression', 'pain catastrophizing', 'pain severity']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.148699,"RESULTS


From baseline to the 6-month follow-up, those in the intervention group had significantly better outcomes for pain severity (p= .01) and pain catastrophizing (p= .003) compared to the control group.","[{'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Miller-Matero', 'Affiliation': 'Behavioral Health, Henry Ford Health, Detroit, Michigan, USA.'}, {'ForeName': 'Lyubov', 'Initials': 'L', 'LastName': 'Gavrilova', 'Affiliation': 'Center for Health Policy and Health Services Research, Henry Ford Health, Detroit, Michigan, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Hecht', 'Affiliation': 'Center for Health Policy and Health Services Research, Henry Ford Health, Detroit, Michigan, USA.'}, {'ForeName': 'Kirsti', 'Initials': 'K', 'LastName': 'Autio', 'Affiliation': 'Center for Health Policy and Health Services Research, Henry Ford Health, Detroit, Michigan, USA.'}, {'ForeName': 'Erin T', 'Initials': 'ET', 'LastName': 'Tobin', 'Affiliation': 'Behavioral Health, Henry Ford Health, Detroit, Michigan, USA.'}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Braciszewski', 'Affiliation': 'Behavioral Health, Henry Ford Health, Detroit, Michigan, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Maye', 'Affiliation': 'Center for Health Policy and Health Services Research, Henry Ford Health, Detroit, Michigan, USA.'}, {'ForeName': 'Julia W', 'Initials': 'JW', 'LastName': 'Felton', 'Affiliation': 'Behavioral Health, Henry Ford Health, Detroit, Michigan, USA.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Ahmedani', 'Affiliation': 'Behavioral Health, Henry Ford Health, Detroit, Michigan, USA.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.13134']
1403,35670414,Single-dose versus multiple-dose antibiotics prophylaxis for preventing caesarean section postpartum infections: A randomized controlled trial.,"BACKGROUND


Caesarean section, a common obstetric surgical procedure, is a major predisposing factor for puerperal infections, requiring the need for antibiotic prophylaxis. Evidence suggests that single-dose antibiotic prophylaxis has comparable efficacy to multiple-dose antibiotic prophylaxis, but with a lower cost and risk of antibiotic resistance. However, single-dose antibiotic prophylaxis after caesarean section is not generally used in many centres in sub-Saharan Africa.
OBJECTIVE


This study aimed to compare the effectiveness of single- versus multiple-dose antibiotic prophylaxis to prevent post-caesarean section infections.
METHODOLOGY


This open-label, randomized controlled trial involved 162 consenting patients admitted for caesarean section (elective or emergency) at the Federal Medical Centre Keffi. They were distributed randomly into treatment arm A or B. Subjects in both arms received intravenous ceftriaxone (1 g) and metronidazole (500 mg) 30-60 min before incision; subjects in arm B received additional parenteral doses for 48 h and then cefuroxime 500 mg tablets every 12 h and metronidazole 400 mg tablets every 8 h for 5 days. The patients were monitored for 2 weeks for evidence of wound infection, febrile morbidity and clinical endometritis.
RESULT


There was no statistical difference in the incidence of wound infection (6.6% versus 7.4%;  p  = .882) and febrile morbidity (11.8% versus 11.1%,  p  = .807). However, clinical endometritis (0.0% versus 6.1%,  p  = .028) was statistically significant with none reported in the single-dose arm.
CONCLUSION


Single-dose ceftriaxone and metronidazole is as effective as multiple doses for antibiotic prophylaxis to prevent post-caesarean section infections. Adoption of this approach in low-risk patients would reduce the cost of prophylactic antibiotics, workload for staff and antibiotic resistance.",2022,"There was no statistical difference in the incidence of wound infection (6.6% versus 7.4%;  p  = .882) and febrile morbidity (11.8% versus 11.1%,  p  = .807).","['162 consenting patients admitted for caesarean section (elective or emergency) at the Federal Medical Centre Keffi', 'low-risk patients', 'caesarean section postpartum infections']","['ceftriaxone and metronidazole', 'Single-dose versus multiple-dose antibiotics prophylaxis', 'intravenous ceftriaxone', 'metronidazole', 'cefuroxime 500\u2009mg tablets every 12\u2009h and metronidazole', 'single- versus multiple-dose antibiotic prophylaxis']","['clinical endometritis', 'wound infection, febrile morbidity and clinical endometritis', 'cost of prophylactic antibiotics, workload for staff and antibiotic resistance', 'febrile morbidity', 'incidence of wound infection']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1124281', 'cui_str': 'Cefuroxime 500 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",162.0,0.0660651,"There was no statistical difference in the incidence of wound infection (6.6% versus 7.4%;  p  = .882) and febrile morbidity (11.8% versus 11.1%,  p  = .807).","[{'ForeName': 'Gerald Tochukwu', 'Initials': 'GT', 'LastName': 'Igwemadu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Federal Medical Centre, Keffi, Nigeria.'}, {'ForeName': 'George Uchenna', 'Initials': 'GU', 'LastName': 'Eleje', 'Affiliation': 'Effective Care Research Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, Nnamdi Azikiwe University, Awka, Nigeria.'}, {'ForeName': 'Enang Enang', 'Initials': 'EE', 'LastName': 'Eno', 'Affiliation': 'Department of Obstetrics and Gynaecology, Federal Medical Centre, Keffi, Nigeria.'}, {'ForeName': 'Uche Augustine', 'Initials': 'UA', 'LastName': 'Akunaeziri', 'Affiliation': 'Department of Obstetrics and Gynaecology, Federal Medical Centre, Keffi, Nigeria.'}, {'ForeName': 'Folashade Adeola', 'Initials': 'FA', 'LastName': 'Afolabi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Federal Medical Centre, Keffi, Nigeria.'}, {'ForeName': 'Abayomi Ibukun', 'Initials': 'AI', 'LastName': 'Alao', 'Affiliation': 'Department of Obstetrics and Gynaecology, Federal Medical Centre, Keffi, Nigeria.'}, {'ForeName': 'Onazi', 'Initials': 'O', 'LastName': 'Ochima', 'Affiliation': 'Department of Obstetrics and Gynaecology, Federal Medical Centre, Keffi, Nigeria.'}]","Women's health (London, England)",['10.1177/17455057221101071']
1404,35671902,A nutrition education intervention to improve eating behaviors of children with autism spectrum disorder: Study protocol for a pilot randomized controlled trial.,"Autism spectrum disorder (ASD) is a developmental disorder that affects communication and social behaviors. Children with ASD often experience mealtime behavior challenges and selective eating behaviors. They also tend to consume fewer fruits and vegetables and more high-energy dense foods, compared to neurotypical peers. A nutrition intervention was designed to prevent the development of feeding disorders and the long-term negative health impacts associated with poor dietary intake. This randomized controlled trial will evaluate the feasibility and preliminary efficacy of the nutrition education intervention for children with ASD and their parents through the Early Intervention (EI) services. We will recruit EI providers and parent-child dyads (n = 48) from EI programs, and randomly assign them into Autism Eats intervention (n = 24) or enhance usual care (EUC) comparison group (n = 24). The Autism Eats is 10 weekly sessions delivered individually as part of EI, while the EUC group will receive only 1 nutrition education session and then weekly parent handouts. The Autism Eats integrates ASD-specific feeding strategies and behaviorally-focused intervention strategies such as goal setting. Feasibility indicators include reach/participation, attrition, completion, fidelity, compatibility, and qualitative participant feedback. Outcome measures include dietary intakes and mealtime behaviors of children with ASD using 3-day food records and a validated questionnaire, the Brief Autism Mealtime Behavior Inventory (BAMBI). We will examine whether there are differences in children's food intakes, variety, diet quality, and mealtime behaviors between Autism Eats and EUC groups at post-intervention and 5-month follow-up assessment. This study will provide critical data to inform a full-scale randomized controlled trial.",2022,"They also tend to consume fewer fruits and vegetables and more high-energy dense foods, compared to neurotypical peers.","['Autism spectrum disorder (ASD', 'children with ASD and their parents through the Early Intervention (EI) services', 'children with autism spectrum disorder', 'Children with ASD']","['Autism Eats intervention (n\u202f=\u202f24) or enhance usual care (EUC) comparison group', 'EUC group will receive only 1 nutrition education session', 'nutrition education intervention']","['eating behaviors', 'dietary intakes and mealtime behaviors of children with ASD using 3-day food records and a validated questionnaire, the Brief Autism Mealtime Behavior Inventory (BAMBI', 'reach/participation, attrition, completion, fidelity, compatibility, and qualitative participant feedback']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0318668,"They also tend to consume fewer fruits and vegetables and more high-energy dense foods, compared to neurotypical peers.","[{'ForeName': 'Heewon L', 'Initials': 'HL', 'LastName': 'Gray', 'Affiliation': 'College of Public Health, University of South Florida, Tampa, FL, United States of America. Electronic address: hlgray@usf.edu.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Pang', 'Affiliation': 'College of Public Health, University of South Florida, Tampa, FL, United States of America. Electronic address: tiantianp@usf.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Agazzi', 'Affiliation': 'Department of Pediatrics, Morsani College of Medicine, University of South Florida, Tampa, FL, United States of America. Electronic address: hcurtis@usf.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Shaffer-Hudkins', 'Affiliation': 'Department of Pediatrics, Morsani College of Medicine, University of South Florida, Tampa, FL, United States of America. Electronic address: eshaffer@usf.edu.'}, {'ForeName': 'Eunsook', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Educational Measurement and Research, College of Education, University of South Florida, Tampa, FL, United States of America. Electronic address: ekim3@usf.edu.'}, {'ForeName': 'Raymond G', 'Initials': 'RG', 'LastName': 'Miltenberger', 'Affiliation': 'Department of Child and Family Studies, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States of America. Electronic address: miltenbe@usf.edu.'}, {'ForeName': 'Karah A', 'Initials': 'KA', 'LastName': 'Waters', 'Affiliation': 'College of Public Health, University of South Florida, Tampa, FL, United States of America. Electronic address: karahwaters@usf.edu.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Jimenez', 'Affiliation': 'College of Public Health, University of South Florida, Tampa, FL, United States of America. Electronic address: cjimenez124@usf.edu.'}, {'ForeName': 'Monise', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'College of Public Health, University of South Florida, Tampa, FL, United States of America. Electronic address: moniseh@usf.edu.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Stern', 'Affiliation': 'Department of Child and Family Studies, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States of America. Electronic address: mstern1@usf.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106814']
1405,35671862,Effect of the traditional Chinese herb Helminthostachys zeylanica on postsurgical recovery in patients with ankle fracture: A double-blinded randomized controlled clinical trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Helminthostachys zeylanica (HZ), which is also called ""Dao-Di-U-Gon"" in Taiwan, has anti-inflammatory and antiedema effects and is commonly used to treat edema in patients with fractures. The ugonin K component of HZ can induce osteogenesis and promote bone mineralization, its therapeutic effect, however, its therapeutic effect remains unclear. Therefore, the purpose of the present study was to investigate the effect of HZ on functional recovery in patients with ankle fractures requiring surgical treatment.
METHODS


A double-blinded, randomized, controlled study was conducted. A total of 45 patients with ankle fractures requiring surgical treatment were assigned to either the control group (n = 23 patients), which received the oral administration of HZ placebo 1.0 g t.i.d. for 42 days continuously, or to the treatment group (22 patients), which received HZ for 42 days.
RESULTS


The serum amino-terminal propeptide of type 1 procollagen (PINP) levels were similar in the first assessment (V1) between the control (45.90 ± 16.31 ng/mL) and treatment groups (52.61 ± 21.02 ng/mL; p = 0.240); the differences in PINP level between the third assessment (V3) and V1 were greater in the treatment group (35.84 ± 24.56 ng/mL) than in the control group (16.34 ± 11.97 ng/mL; p = 0.002). Radiographic healing time (RHT) was 9.09 ± 1.15 weeks in the treatment group, which was shorter than the 9.91 ± 0.79 weeks (p = 0.012) in the control group.
CONCLUSION


Oral administration of HZ for 42 days can increase serum PINP level and reduce the RHT. Therefore, HZ can be used to treat patients with ankle fractures requiring surgical treatment. However, a larger sample size is needed in future studies.",2022,The serum amino-terminal propeptide of type 1 procollagen (PINP) levels were similar in the first assessment (V1) between the control (45.90 ± 16.31ng/mL) and treatment groups (52.61 ± 21.02 ng/mL; p = 0.240); the differences in PINP level between the third assessment (V3) and V1 were greater in the treatment group (35.84 ± 24.56 ng/mL) than in the control group (16.34 ± 11.97 ng/mL; p = 0.002).,"['patients with fractures', 'patients with ankle fractures requiring surgical treatment', '45 patients with ankle fractures requiring surgical treatment', 'patients with ankle fracture']","['HZ', 'traditional Chinese herb Helminthostachys zeylanica', 'oral administration of HZ placebo 1.0\u202fg t.i.d']","['Radiographic healing time (RHT', 'serum amino-terminal propeptide of type 1 procollagen (PINP) levels', 'postsurgical recovery', 'PINP level', 'serum PINP level and reduce the RHT', 'functional recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",45.0,0.163823,The serum amino-terminal propeptide of type 1 procollagen (PINP) levels were similar in the first assessment (V1) between the control (45.90 ± 16.31ng/mL) and treatment groups (52.61 ± 21.02 ng/mL; p = 0.240); the differences in PINP level between the third assessment (V3) and V1 were greater in the treatment group (35.84 ± 24.56 ng/mL) than in the control group (16.34 ± 11.97 ng/mL; p = 0.002).,"[{'ForeName': 'Chin-Horng', 'Initials': 'CH', 'LastName': 'Su', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan; Orthopaedic Department, Yuan-Lin Christian Hospital, Changhua County, 510, Taiwan. Electronic address: cookykooky.tw@gmail.com.'}, {'ForeName': 'Ya-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, Yuan-Lin Christian Hospital, Changhua County, 510, Taiwan. Electronic address: xx91837@yahoo.com.tw.'}, {'ForeName': 'Ya-Hui', 'Initials': 'YH', 'LastName': 'Yang', 'Affiliation': 'Nursing Department, Yuan-Lin Christian Hospital, Changhua County, 510, Taiwan. Electronic address: 1520412@cch.org.tw.'}, {'ForeName': 'Chun-Yi', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Orthopaedic Department, Yuan-Lin Christian Hospital, Changhua County, 510, Taiwan. Electronic address: 1501735@cch.org.tw.'}, {'ForeName': 'Po-Wei', 'Initials': 'PW', 'LastName': 'Ko', 'Affiliation': 'Orthopaedic Department, Yuan-Lin Christian Hospital, Changhua County, 510, Taiwan. Electronic address: 1505224@cch.org.tw.'}, {'ForeName': 'Peng-Ju', 'Initials': 'PJ', 'LastName': 'Huang', 'Affiliation': 'Orthopedic Department, Kaohsiung Medical University Hospital, Kaohsiung, 80708, Taiwan. Electronic address: roger01@ms4.hinet.net.'}, {'ForeName': 'Chih-Chuang', 'Initials': 'CC', 'LastName': 'Liaw', 'Affiliation': 'Department of Marine Biotechnology and Resources, National Sun Yat-sen University, Kaohsiung, 804, Taiwan. Electronic address: ccliaw@mail.nsysu.edu.tw.'}, {'ForeName': 'Wen-Ling', 'Initials': 'WL', 'LastName': 'Liao', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan. Electronic address: wl0129@mail.cmu.edu.tw.'}, {'ForeName': 'Tsung-Lin', 'Initials': 'TL', 'LastName': 'Cheng', 'Affiliation': 'Institute of Statistics and Information Science, National Changhua University of Education, Taiwan. Electronic address: tlcheng@cc.ncue.edu.tw.'}, {'ForeName': 'Der-Yen', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan. Electronic address: deryen.lee@gmail.com.'}, {'ForeName': 'Lun-Chien', 'Initials': 'LC', 'LastName': 'Lo', 'Affiliation': 'School of Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan; Department of Chinese Medicine, China Medical University Hospital, Taichung, 40447, Taiwan. Electronic address: cmulclo@gmail.com.'}, {'ForeName': 'Ching-Liang', 'Initials': 'CL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Chinese Medicine, China Medical University Hospital, Taichung, 40447, Taiwan; Graduate Institute of Acupuncture Science, College of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan; Chinese Medicine Research Center, China Medical University, Taichung, 40402, Taiwan. Electronic address: clhsieh@mail.cmuh.org.tw.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2022.115435']
1406,35672178,Safety and immunogenicity of a quadrivalent seasonal influenza vaccine adjuvanted with hydroxypropyl-β-cyclodextrin: A phase 1 clinical trial.,"OBJECTIVES


Hydroxypropyl-β-cyclodextrin (HP-β-CyD), an oligosaccharide used as an excipient in pharmaceutical preparation, was recently reported to function as a vaccine adjuvant to co-administered antigens. In this study, we investigated the safety and immunogenicity of a seasonal influenza vaccine adjuvanted with HP-β-CyD (FluCyD-vac) in healthy adults compared with those of a standard seasonal influenza vaccine (Flu-vac).
METHODS


We conducted a single-blinded randomized phase 1 clinical trial study, and used two quadrivalent split seasonal influenza vaccines: FluCyD-vac containing 9 μg of HA/strain and 20% w/v of HP-β-CyD, and Flu-vac containing 15 μg of hemagglutinin (HA)/strain only. All participants were randomly assigned to receive a single dose of Flu/CyD-vac or Flu-vac at a ratio of 2:1. We assessed solicited and unsolicited adverse events (AEs) and immune responses using hemagglutination inhibition (HI) titers. In addition, we assessed T-cell function in peripheral blood mononuclear cells (PBMCs), after stimulation with HA vaccine strains, using flow cytometry.
RESULTS


Among 36 healthy volunteers enrolled in the study (FluCyD-vac, n = 24; Flu-vac, n = 12), FluCyD-vac was well tolerated. Most of the solicited AEs were mild local skin reactions at the injection site. No serious AEs were reported in either group. HI titers 21 days after vaccination with FluCyD-vac were comparable with those of Flu-vac and sufficient to meet international criteria, despite reduced HA antigen doses. When PBMCs were stimulated with the four HA antigens in the vaccine, tumor necrosis factor (TNF)-α-producing CD4 +  T cells were enhanced in the FluCyD-vac group.
CONCLUSION


FluCyD-vac was well-tolerated and immunogenic, despite containing 40% less HA antigens than Flu-vac. This study showed that HP-β-CyD is a potentially safe, novel adjuvant for human influenza vaccine.
CLINICAL TRIAL REGISTRY


UMIN000028530.",2022,No serious AEs were reported in either group.,"['36 healthy volunteers enrolled in the study (FluCyD-vac, n\xa0=\xa024; Flu-vac, n\xa0=\xa012), FluCyD-vac was well tolerated', 'healthy adults']","['standard seasonal influenza vaccine (Flu-vac', 'seasonal influenza vaccine adjuvanted with HP-β-CyD (FluCyD-vac', 'HP-β-CyD', 'Hydroxypropyl-β-cyclodextrin (HP-β-CyD', 'quadrivalent seasonal influenza vaccine adjuvanted with hydroxypropyl-β-cyclodextrin', 'Flu/CyD-vac or Flu-vac', 'quadrivalent split seasonal influenza vaccines: FluCyD-vac containing 9\xa0μg of HA/strain and 20% w/v of HP-β-CyD, and Flu-vac containing 15\xa0μg of hemagglutinin (HA)/strain only']","['safety and immunogenicity', 'T-cell function in peripheral blood mononuclear cells (PBMCs', 'solicited and unsolicited adverse events (AEs) and immune responses using hemagglutination inhibition (HI) titers', 'mild local skin reactions', 'tumor necrosis factor (TNF)-α-producing CD4 +  T cells', 'Safety and immunogenicity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C0010558', 'cui_str': 'Cyclodextrins'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0560267', 'cui_str': 'w/v'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}]",36.0,0.144198,No serious AEs were reported in either group.,"[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, Osaka University, Suita, Japan; Laboratory of Thermo-therapeutics for vascular dysfunction, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Sumiyuki', 'Initials': 'S', 'LastName': 'Nishida', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, Osaka University, Suita, Japan. Electronic address: sumiyuki-n@imed3.med.osaka-u.ac.jp.'}, {'ForeName': 'Temizöz', 'Initials': 'T', 'LastName': 'Burcu', 'Affiliation': 'Center for Vaccine and Adjuvant Research, National Institutes of Biomedical Innovation, Health and Nutrition, Ibaraki, Osaka, Japan; Laboratory of Vaccine Science, Immunology Frontier Research Center, Osaka University, Suita, Osaka, Japan; Division of Vaccine Science, Department of Microbiology and Immunology, Institute of Medical Science, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Shibahara', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, Osaka University, Suita, Japan; Center for Vaccine and Adjuvant Research, National Institutes of Biomedical Innovation, Health and Nutrition, Ibaraki, Osaka, Japan.'}, {'ForeName': 'Takato', 'Initials': 'T', 'LastName': 'Kusakabe', 'Affiliation': 'Center for Vaccine and Adjuvant Research, National Institutes of Biomedical Innovation, Health and Nutrition, Ibaraki, Osaka, Japan.'}, {'ForeName': 'Etsushi', 'Initials': 'E', 'LastName': 'Kuroda', 'Affiliation': 'Department of Immunology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Ken J', 'Initials': 'KJ', 'LastName': 'Ishii', 'Affiliation': 'Center for Vaccine and Adjuvant Research, National Institutes of Biomedical Innovation, Health and Nutrition, Ibaraki, Osaka, Japan; Laboratory of Vaccine Science, Immunology Frontier Research Center, Osaka University, Suita, Osaka, Japan; Division of Vaccine Science, Department of Microbiology and Immunology, Institute of Medical Science, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kumanogoh', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, Osaka University, Suita, Japan; Department of Immunopathology, WPI, Immunology Frontier Research Center (iFReC), Osaka University, Suita, Osaka, Japan; Integrated Frontier Research for Medical Science Division, Institute for Open and Transdisciplinary Research Initiatives (OTRI), Osaka University, Suita, Osaka, Japan; Center for Infectious Diseases for Education and Research (CiDER), Osaka University, Suita, Osaka, Japan.'}]",Vaccine,['10.1016/j.vaccine.2022.05.060']
1407,35675275,Morning light treatment for traumatic stress: The role of amygdala reactivity study protocol.,"BACKGROUND


Exposure to trauma can result in various mental health disorders including anxiety, depression, and posttraumatic stress disorder (PTSD). Although psychotherapies and pharmacotherapies exist for the treatment of these disorders, many individuals fail to receive treatment and among those who do, many remain symptomatic. Therefore, it is critical to continue developing new interventions for traumatic stress that target underlying mechanisms of pathology and offer a safe and acceptable alternative to current treatments. Morning light treatment has good potential as a novel non-invasive, low risk treatment for traumatic stress. Evidence suggests that morning light may improve traumatic stress by reducing reactivity in the amygdala, a brain region implicated in the pathophysiology of PTSD and anatomically linked to circadian photoreceptors in the eye.
METHODS


In this study, we aim to establish a significant dose-response relationship between duration of morning light treatment and reduction in amygdala reactivity among individuals with traumatic stress symptoms (NCT# 04117347). Using a transdiagnostic approach, sixty-six individuals with a history of a DSM-5 criterion A trauma and traumatic stress symptoms will be recruited to participate in a 5-week study. Participants will be randomized across three treatment arms based on morning light treatment duration: 15-minutes, 30-minutes, or 60-minutes of light treatment per day for four weeks. To evaluate amygdala activity, participants will undergo fMRI at pre-treatment, mid-treatment, and post-treatment. Participants will also complete clinical assessments and self-report measures of PTSD, depression, and anxiety at pre-treatment, mid-treatment, and post-treatment.
DISCUSSION


Morning light therapy may be an acceptable, feasible, and effective treatment for individuals suffering from traumatic stress. Identifying mechanistically relevant targets, and the doses needed to impact them, are critical steps in developing this new treatment approach for the sequelae of traumatic stress.",2022,"Evidence suggests that morning light may improve traumatic stress by reducing reactivity in the amygdala, a brain region implicated in the pathophysiology of PTSD and anatomically linked to circadian photoreceptors in the eye.
","['individuals with traumatic stress symptoms (NCT# 04117347', 'traumatic stress', 'individuals suffering from traumatic stress', 'sixty-six individuals with a history of a DSM-5 criterion A trauma and traumatic stress symptoms']",[],"['traumatic stress', 'complete clinical assessments and self-report measures of PTSD, depression, and anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",[],"[{'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",66.0,0.0561017,"Evidence suggests that morning light may improve traumatic stress by reducing reactivity in the amygdala, a brain region implicated in the pathophysiology of PTSD and anatomically linked to circadian photoreceptors in the eye.
","[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Cenkner', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, California, United States of America.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Burgess', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Huizenga', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duval', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Hyungjin Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Consulting for Statistics, Computing & Analytics Research, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, Columbus, Ohio, United States of America.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Texas A&M University, Bryan, Texas, United States of America.'}, {'ForeName': 'Heide', 'Initials': 'H', 'LastName': 'Klumpp', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Abelson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Horwitz', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Mooney', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Greta B', 'Initials': 'GB', 'LastName': 'Raglan', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Alyson K', 'Initials': 'AK', 'LastName': 'Zalta', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0269502']
1408,35675601,Timing of Adjunctive Azithromycin for Unscheduled Cesarean Delivery and Postdelivery Infection.,"OBJECTIVE


To estimate the association between timing of administration of adjunctive azithromycin for prophylaxis at unscheduled cesarean delivery and maternal infection and neonatal morbidity.
METHODS


We conducted a secondary analysis of a randomized trial of adjunctive azithromycin prophylaxis in patients with singleton gestations who were undergoing unscheduled cesarean delivery. The primary exposure was the timing of initiation of the study drug (after skin incision or 0-30 minutes, more than 30-60 minutes, or more than 60 minutes before skin incision). The primary outcome was a composite of endometritis, wound infection, and other maternal infections occurring up to 6 weeks after cesarean delivery. Secondary outcomes included composite neonatal morbidity, neonatal intensive care unit admission for longer than 72 hours, and neonatal sepsis. The association of azithromycin with outcomes was compared within each antibiotic timing group and presented as risk ratios (RRs) with 95% CIs. A Breslow-Day homogeneity test was applied to assess differences in association by antibiotic timing.
RESULTS


Of 2,013 participants, antibiotics were initiated after skin incision (median 3 minutes, range 0-229 minutes) in 269 (13.4%), 0-30 minutes before skin incision in 1,378 (68.5%), more than 30-60 minutes before skin incision in 270 (13.4%), and more than 60 minutes before skin incision (median 85 minutes, range 61-218 minutes) in 96 (4.8%). The RRs (95% CIs) of the infectious composite outcome for azithromycin compared with placebo were significantly lower for groups that initiated azithromycin after skin incision or within 1 hour before skin incision (after skin incision: RR 0.31, 95% CI 0.13-0.76; 0-30 minutes before: RR 0.62, 95% CI 0.44-0.89; more than 30-60 minutes before: 0.31, 95% CI 0.13-0.66). Risks were not significantly different in patients who received azithromycin more than 60 minutes before skin incision (RR 0.59, 95% CI 0.10-3.36). Results were similar when endometritis and wound infections were analyzed separately. Neonatal outcomes were not significantly different for azithromycin compared with placebo across all timing groups.
CONCLUSION


Adjunctive azithromycin administration up to 60 minutes before or at a median of 3 minutes after skin incision was associated with reduced risks of maternal composite postoperative infection in unscheduled cesarean deliveries.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01235546.",2022,"The RRs (95% CIs) of the infectious composite outcome for azithromycin compared with placebo were significantly lower for groups that initiated azithromycin after skin incision or within 1 hour before skin incision (after skin incision: RR 0.31, 95% CI 0.13-0.76; 0-30 minutes before: RR 0.62, 95% CI 0.44-0.89; more than 30-60 minutes before: 0.31, 95% CI 0.13-0.66).","['2,013 participants', 'patients with singleton gestations who were undergoing unscheduled cesarean delivery']","['adjunctive azithromycin prophylaxis', 'azithromycin', 'Adjunctive Azithromycin', 'adjunctive azithromycin', 'placebo', 'skin incision ']","['unscheduled cesarean delivery and maternal infection and neonatal morbidity', 'Neonatal outcomes', 'endometritis and wound infections', 'composite neonatal morbidity, neonatal intensive care unit admission for longer than 72 hours, and neonatal sepsis', 'composite of endometritis, wound infection, and other maternal infections', 'Unscheduled Cesarean Delivery and Postdelivery Infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}]","[{'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0239997', 'cui_str': 'Maternal infection'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.406703,"The RRs (95% CIs) of the infectious composite outcome for azithromycin compared with placebo were significantly lower for groups that initiated azithromycin after skin incision or within 1 hour before skin incision (after skin incision: RR 0.31, 95% CI 0.13-0.76; 0-30 minutes before: RR 0.62, 95% CI 0.44-0.89; more than 30-60 minutes before: 0.31, 95% CI 0.13-0.66).","[{'ForeName': 'Ayodeji', 'Initials': 'A', 'LastName': 'Sanusi', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, the Center for Women's Reproductive Health, and the Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama; the Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, and Mission Hospital, Asheville, North Carolina; and the Departments of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, Texas, Ochsner Health System, New Orleans, Louisiana, University of Utah and Intermountain Health Care, Salt Lake City, Utah, Columbia University, New York, New York, University of Mississippi, Jackson, Mississippi, University of Texas Health Sciences Center, Houston, Texas.""}, {'ForeName': 'Yuanfan', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Boggess', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': ''}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Esplin', 'Affiliation': ''}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Cleary', 'Affiliation': ''}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Blackwell', 'Affiliation': ''}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Subramaniam', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004788']
1409,35682348,A Comparison of Acute Effects of Climbing Therapy with Nordic Walking for Inpatient Adults with Mental Health Disorder: A Clinical Pilot Trial.,"As climbing therapy is increasingly used for mental health disorders, the present study aimed to compare acute effects of a therapeutic climbing intervention (CT) on affective responses, anxiety, and self-efficacy with those of Nordic walking (NW) and a sedentary control condition (SC) in an inpatient setting with persons with depression, anxiety, or obsessive-compulsive disorders. A total of 21 inpatients (32 ± 12.2 years) participated in a clinical trial in all interventions using an experimental within-subject design. Anxiety and self-efficacy were assessed preintervention (t 0 ) and postintervention (t 2 ) using the State-Trait Anxiety Inventory and the General Self-Efficacy Scale, and affective responses were additionally evaluated during (t 1 ) and 180 min after the intervention (t 3 ) using the Feeling Scale, Felt Arousal Scale, and Positive and Negative Affect Schedule. Statistical evaluation was performed with a 3 × 2 or 3 × 4 repeated measures ANOVA. Significant interaction effects were found for affective responses regarding positive affect, affective valence, and perceived activation ( p  &lt; 0.015) favoring CT over NW and SC. For anxiety, a significant interaction effect was found (F(2.40) = 6.603;  p  = 0.003; η 2  = 0.248), and also perceived self-efficacy increased significantly (F(2.40) = 6.046;  p  = 0.005; η 2  = 0.232). Single CT sessions may enhance affective responses and self-efficacy and reduce anxiety in inpatients with mental health disorders to a higher extent than NW. CT as part of an inpatient therapy program may help to improve key affective mechanisms and should be further studied in comparison with other exercise interventions with comparable intensity.",2022,Single CT sessions may enhance affective responses and self-efficacy and reduce anxiety in inpatients with mental health disorders to a higher extent than NW.,"['A total of 21 inpatients (32 ± 12.2 years) participated in a clinical trial in all interventions using an experimental within-subject design', 'inpatients with mental health disorders', 'Inpatient Adults with Mental Health Disorder', 'persons with depression, anxiety, or obsessive-compulsive disorders']","['Climbing Therapy with Nordic Walking', 'Single CT sessions', 'therapeutic climbing intervention (CT', 'Nordic walking (NW) and a sedentary control condition (SC', 'CT']","['perceived self-efficacy', 'Anxiety and self-efficacy', 'affective responses and self-efficacy and reduce anxiety', 'State-Trait Anxiety Inventory and the General Self-Efficacy Scale, and affective responses', 'affective responses regarding positive affect, affective valence, and perceived activation', 'Feeling Scale, Felt Arousal Scale, and Positive and Negative Affect Schedule', 'affective responses, anxiety, and self-efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]","[{'cui': 'C0561942', 'cui_str': 'Does climb'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}]",21.0,0.00327639,Single CT sessions may enhance affective responses and self-efficacy and reduce anxiety in inpatients with mental health disorders to a higher extent than NW.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Thaller', 'Affiliation': 'Department of Sports Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Frühauf', 'Affiliation': 'Department of Sports Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Heimbeck', 'Affiliation': 'Schoen Clinic Roseneck, 83209 Prien am Chiemsee, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Voderholzer', 'Affiliation': 'Schoen Clinic Roseneck, 83209 Prien am Chiemsee, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kopp', 'Affiliation': 'Department of Sports Science, University of Innsbruck, 6020 Innsbruck, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph19116767']
1410,35682322,Effectiveness of a Worksite-Based Lifestyle Intervention on Employees' Obesity Control and Prevention in China: A Group Randomized Experimental Study.,"Background : This study was to culturally adapt a lifestyle intervention for employees' obesity control and prevention using a participatory process, and evaluate the effectiveness of the project at worksites.  Methods : A group randomized experimental study included four worksites (two intervention, two control) in the Yangtze River Delta in China was conducted. A total of 388 participants (216 in the intervention worksites and 172 in the control worksites) were finally recruited from 955 employees at the four worksites (464 in the intervention worksites and 491 in the control worksites). The final evaluation was completed by two hundred and seventy-eight employees (159 in the intervention worksites and 119 in the control worksites, respectively). Data of demographic information, weight, BMI, waist circumference, hip circumference and weight-related behaviors including diary behaviors and physical activities were collected before and after a 12-month intervention and analyzed using descriptive statistics,  t -test, chi-square test, linear mixed regression and logistic mixed regression.  Results : Although the intervention worksites had a reduction in body mass index (23.21 to 22.95,  p  &lt; 0.01), hip circumference (95.97 to 95.28,  p  = 0.03) and waist-to-height ratio (0.49 to 0.48,  p  = 0.01), the differential changes compared to those of the control group were not statistically significant. The frequency of sweet beverages (-1.81, 95%CI: -0.52, -3.11), frequency of vegetable intake (5.66, 95%CI: 1.59, 9.74), daily servings of vegetables (0.53, 95%CI: 0.24, 0.82), frequency of fruit intake (3.68, 95%CI: 1.25, 6.12), daily servings of fruit (0.26, 95%CI: 0.44, 0.92), daily servings of vegetables and fruit (0.79, 95%CI: 0.43, 1.16), daily steps (863.19, 95%CI: 161.42, 1564.97) and self-efficacy to change physical activity (OR = 1.91, 95%CI: 1.02,3.60) were more improved in the intervention group than were those measures in the control group.  Conclusions : The worksite-based lifestyle intervention project for obesity control and prevention improved several employees' dietary behaviors and physical activities at worksites in China in a short time. Long-term intervention with larger samples in more worksites should be further examined.",2022,"Although the intervention worksites had a reduction in body mass index (23.21 to 22.95,  p  &lt; 0.01), hip circumference (95.97 to 95.28,  p  = 0.03) and waist-to-height ratio (0.49 to 0.48,  ","['four worksites (two intervention, two control) in the Yangtze River Delta in China was conducted', '388 participants (216 in the intervention worksites and 172 in the control worksites) were finally recruited from 955 employees at the four worksites (464 in the intervention worksites and 491 in the control worksites', ""Employees' Obesity Control and Prevention in China"", 'two hundred and seventy-eight employees (159 in the intervention worksites and 119 in the control worksites, respectively']","['worksite-based lifestyle intervention project for obesity control and prevention', 'Worksite-Based Lifestyle Intervention', 'lifestyle intervention', ' ']","['hip circumference', 'daily servings of vegetables', 'daily servings of vegetables and fruit', 'waist-to-height ratio', 'body mass index', 'frequency of vegetable intake', ""several employees' dietary behaviors and physical activities"", 'demographic information, weight, BMI, waist circumference, hip circumference and weight-related behaviors including diary behaviors and physical activities', 'frequency of fruit intake', 'frequency of sweet beverages', 'self-efficacy to change physical activity']","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337050', 'cui_str': 'River'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",388.0,0.0456933,"Although the intervention worksites had a reduction in body mass index (23.21 to 22.95,  p  &lt; 0.01), hip circumference (95.97 to 95.28,  p  = 0.03) and waist-to-height ratio (0.49 to 0.48,  ","[{'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Investment and Insurance, Zhejiang Financial College, Hangzhou 310018, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Social Medicine, Zhejiang University School of Public Health, Hangzhou 310058, China.'}, {'ForeName': 'Yingjing', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Social Medicine, Zhejiang University School of Public Health, Hangzhou 310058, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Health Development Research Centre (Shanghai Medical Information Centre), Shanghai 200031, China.'}, {'ForeName': 'Boyan', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Social Medicine, Zhejiang University School of Public Health, Hangzhou 310058, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Social Medicine, Zhejiang University School of Public Health, Hangzhou 310058, China.'}, {'ForeName': 'Mengna', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Social Medicine, Zhejiang University School of Public Health, Hangzhou 310058, China.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Patrick', 'Affiliation': 'Department of Health Systems and Population Health, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Shirley A A', 'Initials': 'SAA', 'LastName': 'Beresford', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Social Medicine, Zhejiang University School of Public Health, Hangzhou 310058, China.'}]",International journal of environmental research and public health,['10.3390/ijerph19116738']
1411,35682305,Influence of Sit-Stand Tables in Classrooms on Children's Sedentary Behavior and Teacher's Acceptance and Feasibility: A Mixed-Methods Study.,"Children spend over 70% of their school day sitting, most of the time in the classroom. Even when meeting physical activity guidelines but sitting for long uninterrupted periods, children are at risk of poorer health outcomes. With an approach to create an active learning environment through the implementation of sit-stand tables, this exploratory mixed-methods study aims to evaluate a holistic concept for reducing sedentary time in schools by implementing sit-stand tables as well as to examine the feasibility and didactic usability in classroom settings. Children from eight German schools aged 7 to 10 in primary schools and 11 to 13 in secondary schools ( n  = 211), allocated into control and intervention groups, were included in the study, as well as teachers ( n  = 13). An accelerometer was used as a quantitative measure to assess sitting and standing times and sport motoric tests were taken. Qualitative interviews were performed with teachers regarding feasibility and acceptance of the sit-stand tables. Independent  t -test analysis adjusted for age, sex and school type found that sitting times of children in the intervention group could be reduced (by 30.54 min per school day of 6 h,  p  &lt; 0.001) within all school and age levels. Overall, implementing sit-stand tables in classrooms serves as a feasible and effective opportunity to reduce sedentary behaviour and create an active learning environment.",2022,"Independent  t -test analysis adjusted for age, sex and school type found that sitting times of children in the intervention group could be reduced (by 30.54 min per school day of 6 h,  p  &lt; 0.001) within all school and age levels.","['Children from eight German schools aged 7 to 10 in primary schools and 11 to 13 in secondary schools ( n  = 211), allocated into control and intervention groups, were included in the study, as well as teachers ( n  = 13']",['Sit-Stand Tables'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0039224', 'cui_str': 'Table'}]",[],,0.0403663,"Independent  t -test analysis adjusted for age, sex and school type found that sitting times of children in the intervention group could be reduced (by 30.54 min per school day of 6 h,  p  &lt; 0.001) within all school and age levels.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Schwenke', 'Affiliation': 'Institute for Medical Information Processing, Biometry, and Epidemiology-IBE, Chair of Public Health and Health Services Research, LMU Munich, Elisabeth-Winterhalter-Weg 6, 81377 Munich, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Coenen', 'Affiliation': 'Institute for Medical Information Processing, Biometry, and Epidemiology-IBE, Chair of Public Health and Health Services Research, LMU Munich, Elisabeth-Winterhalter-Weg 6, 81377 Munich, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19116727']
1412,35682239,Cancer Screening Program Delivered by Community Health Workers for Chinese Married Immigrant Women in Korea.,"This quasi-experimental study used a cancer prevention program delivered by community health workers (CHWs) as an intervention to improve health literacy and increase screening uptake. The intervention group was educated by trained CHWs and received information about the nearby hospitals. After education, participants received telephone counseling once a month for 6 months. In the intervention group, CHWs met the participants individually and delivered the CD-ROM containing conversation scenarios with voice during the cancer screening test. The control group was provided educational materials related to breast and cervical cancers and a booklet containing information on mammography and Pap test. This study assessed the difference in mammography and Pap tests between the intervention and control groups. The results showed that the participants' knowledge improved, and the rate of cancer screening tests did not decrease in the intervention group. Therefore, it is necessary to develop and apply various programs that train CHWs and apply them to immigrant women to promote health-related behaviors under the health system that they are not familiar with while living in another country.",2022,"The results showed that the participants' knowledge improved, and the rate of cancer screening tests did not decrease in the intervention group.",['Chinese Married Immigrant Women in Korea'],"['educational materials related to breast and cervical cancers and a booklet containing information on mammography and Pap test', 'trained CHWs and received information about the nearby hospitals', 'Cancer Screening Program Delivered by Community Health Workers', 'telephone counseling', 'cancer prevention program delivered by community health workers (CHWs']","['mammography and Pap tests', 'rate of cancer screening tests']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C2717746', 'cui_str': 'Cancer Screening Tests'}]",,0.022653,"The results showed that the participants' knowledge improved, and the rate of cancer screening tests did not decrease in the intervention group.","[{'ForeName': 'Jiyun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'School of Nursing, Gachon University, Incheon 21936, Korea.'}, {'ForeName': 'Yuna', 'Initials': 'Y', 'LastName': 'Paik', 'Affiliation': 'School of Nursing, Gachon University, Incheon 21936, Korea.'}, {'ForeName': 'Seungmi', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Nursing Science, Chungbuk National University, Cheongju 28644, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph19116655']
1413,35682129,Effects of Music Therapy on Vital Signs in Children with Chronic Disease.,"BACKGROUND


Recent research found evidence supporting music therapy for hospitalized children with chronic diseases. The aim of this study was to investigate the effect of music therapy on hospitalized children's vital signs.
METHODS


In this prospective study, children with chronic gastroenterological and nephrological diseases received active or receptive music therapy two to four times a week until discharge from hospital at the pediatric special care unit (SCU) and pediatric intensive care unit (ICU). Baseline and post-therapy heart rate, oxygen saturation and blood pressure were recorded and analyzed as control values at three points on the same day when the children were alone in their patient room at rest.
RESULTS


A total of 83 children, median 3 age of years (range one month to eighteen years) received music therapy. In total, 377 music therapy sessions were treated: 200 receptive therapy (78 ICU, 122 SCU) and 177 with active therapy (0 ICU, 177 SCU). Music therapy interventions showed changes in vital signs during music therapy sessions. After music therapy, heart rates decreased by 18 beats per minute (95% confidence interval (CI), -19.4 to (-16.8)), oxygen saturation increased by 2.3% (95% CI, 2.2 to 2.5), systolic blood pressure decreased by 9.2 (95% CI, -10.6 to -7.7) and diastolic blood pressure decreased by 7.9 (95% CI, -9.6 to -6.3). When music therapy was applied at the SCU (ICU), heart rates significantly reduced by 17.9 (18.9) beats per min, oxygen saturation increased by 2.4% (2.1%) and blood pressure reduced by 9.2 (2.8) mmHg (systolic) and 7.9 (0.3) mmHg (diastolic). Almost all control values were better than directly before the intervention. However, after music therapy intervention, the children showed better values in vital signs compared to being alone in their patient room.
CONCLUSION


Music therapy is an added value for children with kidney and liver/gastrointestinal diseases during their hospital stay.",2022,"After music therapy, heart rates decreased by 18 beats per minute (95% confidence interval (CI), -19.4 to (-16.8)), oxygen saturation increased by 2.3% (95% CI, 2.2 to 2.5), systolic blood pressure decreased by 9.2 (95% CI, -10.6 to -7.7) and diastolic blood pressure decreased by 7.9 (95% CI, -9.6 to -6.3).","['Children with Chronic Disease', 'hospitalized children with chronic diseases', '83 children, median 3 age of years (range one month to eighteen years) received', ""hospitalized children's vital signs"", 'children with kidney and liver/gastrointestinal diseases during their hospital stay', 'children with chronic gastroenterological and nephrological diseases received']","['active or receptive music therapy two to four times a week until discharge from hospital at the pediatric special care unit (SCU) and pediatric intensive care unit (ICU', 'music therapy', 'Music therapy interventions', 'Music therapy', 'Music Therapy']","['diastolic blood pressure', 'Baseline and post-therapy heart rate, oxygen saturation and blood pressure', 'heart rates', 'oxygen saturation', 'vital signs', 'blood pressure', 'systolic blood pressure', 'Vital Signs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C4082106', 'cui_str': 'Two to four times'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0558600', 'cui_str': 'Special care unit'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",83.0,0.0438479,"After music therapy, heart rates decreased by 18 beats per minute (95% confidence interval (CI), -19.4 to (-16.8)), oxygen saturation increased by 2.3% (95% CI, 2.2 to 2.5), systolic blood pressure decreased by 9.2 (95% CI, -10.6 to -7.7) and diastolic blood pressure decreased by 7.9 (95% CI, -9.6 to -6.3).","[{'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Kobus', 'Affiliation': 'Center of Artistic Therapy, University Medicine Essen, 45147 Essen, Germany.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Buehne', 'Affiliation': ""Clinic for Pediatrics II, University Children's Hospital Essen, 45147 Essen, Germany.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kathemann', 'Affiliation': ""Clinic for Pediatrics II, University Children's Hospital Essen, 45147 Essen, Germany.""}, {'ForeName': 'Anja K', 'Initials': 'AK', 'LastName': 'Buescher', 'Affiliation': ""Clinic for Pediatrics II, University Children's Hospital Essen, 45147 Essen, Germany.""}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Lainka', 'Affiliation': ""Clinic for Pediatrics II, University Children's Hospital Essen, 45147 Essen, Germany.""}]",International journal of environmental research and public health,['10.3390/ijerph19116544']
1414,35682528,Effect of Strength vs. Plyometric Training upon Change of Direction Performance in Young Female Handball Players.,"The aim of the current study was to investigate the effect of six weeks of strength vs. plyometric training upon change of direction (COD) performance. A total of 21 young female handball players were randomly assigned to either a strength group: (n = 11, age: 17.5 ± 2.3 years, height: 1.69 ± 0.05 m, weight: 65.8 ± 5.9 kg) training bilateral, unilateral and later squats; or a plyometric training group (n = 10, age: 17.1 ± 2.4 years, height: 1.73 ± 0.07 m, weight: 67.1 ± 9.3 kg) training drop jumps, unilateral countermovement jumps and skate-jumps. Groups were assigned after being pair-matched based upon baseline COD performance. The training modalities were matched in training impulse. A force- (180°) and velocity-oriented (45°) COD of 20 m was used to measure changes in COD performance (10 m + COD + 10 m). Total time (s) to complete the COD test was defined as the performance variable. The level of significance was set at  p  &lt; 0.05. The two-way ANOVA showed no group effect upon COD performance. A significant effect was only observed for the strength training group in the last 10 m and total 20 m of the force-oriented COD (F ≥ 5.51;  p  ≤ 0.04; η 2  ≥ 0.36). Both groups improved performance in other strength- and power-related tests. It was concluded that only the strength training program was effective in developing force-oriented COD performance in the studied population, while the plyometric training program was not sufficient. Both training modalities are useful for improving performance in different strength and power tests in young female handball players.",2022,A significant effect was only observed for the strength training group in the last 10 m and total 20 m of the force-oriented COD (F ≥ 5.51;  ,"['young female handball players', 'Young Female Handball Players', '21 young female handball players', 'group (n = 10, age: 17.1 ± 2.4 years, height: 1.73 ± 0.07 m, weight: 67.1 ± 9.3 kg']","['training drop jumps, unilateral countermovement jumps and skate-jumps', 'strength vs. plyometric training', 'strength training', 'velocity-oriented (45°', 'strength training program', 'training bilateral, unilateral and later squats; or a plyometric training', 'Strength vs. Plyometric Training']","['COD performance', 'Total time (s) to complete the COD test', 'change of direction (COD) performance', 'Direction Performance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4518239', 'cui_str': '0.07'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0037246', 'cui_str': 'Family Rajidae - skate'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",21.0,0.0100537,A significant effect was only observed for the strength training group in the last 10 m and total 20 m of the force-oriented COD (F ≥ 5.51;  ,"[{'ForeName': 'Hallvard Nygaard', 'Initials': 'HN', 'LastName': 'Falch', 'Affiliation': 'Department of Sports Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}, {'ForeName': 'Markus Estifanos', 'Initials': 'ME', 'LastName': 'Haugen', 'Affiliation': 'Department of Sports Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}, {'ForeName': 'Eirik Lindset', 'Initials': 'EL', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Sports Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sports Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph19116946']
1415,35682461,Effects of Tongue-Strengthening Exercise on Tongue Strength Reserve and Detraining Effects among Healthy Adults: A Randomized Controlled Trial.,"INTRODUCTION


Tongue strength reserve is the difference between the maximum isometric pressure (MIP) and swallowing pressure of the tongue. People with decreased tongue strength reserve may have a higher risk of presbyphagia or dysphagia. Thus, this study explored the effects of tongue strengthening exercise (TSE) on tongue strength reserve and detraining effects in healthy adults.
MATERIALS AND METHODS


In total, 102 healthy volunteers without any reported history of speech or swallowing deficits were recruited and assigned to experimental ( n  = 50) and control groups ( n  = 52). Exercises in the experimental group consisted of compressing an air-filled bulb between the tongue and hard palate for 30 min a day, 5 days a week, for 8 weeks. Thereafter, the experimental group underwent a 4-week detraining period.
RESULTS


Following the TSE training, posterior tongue strength reserve (F = 4.92,  p  = 0.029) of the experimental group was significantly higher than that of the control group. No significant detraining effects were observed on the MIP and swallowing pressure from 4 weeks after the completion of TSE training.
CONCLUSIONS


According to the study results, TSE may be an effective approach for improving swallowing function.",2022,"No significant detraining effects were observed on the MIP and swallowing pressure from 4 weeks after the completion of TSE training.
","['Healthy Adults', 'healthy adults', '102 healthy volunteers without any reported history of speech or swallowing deficits']","['tongue strengthening exercise (TSE', 'Tongue-Strengthening Exercise', 'TSE']","['MIP and swallowing pressure', 'swallowing function', 'maximum isometric pressure (MIP) and swallowing pressure', 'posterior tongue strength reserve', 'Tongue Strength Reserve and Detraining Effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0226958', 'cui_str': 'Structure of root of tongue'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",102.0,0.0199167,"No significant detraining effects were observed on the MIP and swallowing pressure from 4 weeks after the completion of TSE training.
","[{'ForeName': 'Hui-Ling', 'Initials': 'HL', 'LastName': 'Hsiao', 'Affiliation': 'Department of Nursing, Central Taiwan University of Science and Technology, Taichung 40601, Taiwan.'}, {'ForeName': 'Jiunn-Horng', 'Initials': 'JH', 'LastName': 'Lou', 'Affiliation': 'Department of Nursing, Hsin Sheng Junior College of Medical Care and Management, Taoyuan 32544, Taiwan.'}, {'ForeName': 'Chun-Chieh', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Taichung Veterans General Hospital Puli Branch, Nantou 54552, Taiwan.'}, {'ForeName': 'Yun-Ju', 'Initials': 'YJ', 'LastName': 'Lai', 'Affiliation': 'Department of Internal Medicine, Taichung Veterans General Hospital Puli Branch, Nantou 54552, Taiwan.'}, {'ForeName': 'Shang-Jung', 'Initials': 'SJ', 'LastName': 'Wu', 'Affiliation': 'Department of Nursing, Taichung Veterans General Hospital Puli Branch, Nantou 54552, Taiwan.'}, {'ForeName': 'Yueh-Juen', 'Initials': 'YJ', 'LastName': 'Hwu', 'Affiliation': 'College of Nursing, Central Taiwan University of Science and Technology, Taichung 40601, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19116878']
1416,35682397,The Cost-Effectiveness Analysis of an Integrated Mental Health Care Programme in Germany.,"The network for mental health (NWpG = Netzwerk psychische Gesundheit) is an umbrella association for non-medical community mental health care facilities across Germany which are enabled to provide multi-professional mental health care packages including medical and psychosocial services reimbursed by German statutory health insurances since 2009. The aim of this study is to analyse the cost-effectiveness of providing NWpG mental health care packages plus treatment as usual (NWpG) to treatment as usual alone (TAU) in Germany. In a prospective, multicenter, controlled trial over 18 months, a total of 511 patients (NWpG = 251; TAU = 260) were observed in five regions, four times at six-month intervals. The EQ-5D-3L and the Client Sociodemographic and Service Receipt Inventory (CSSRI) were used to estimate quality-adjusted life-years and total costs of illness. Propensity score-adjusted cost-utility analysis was applied using the net benefit approach. No significant differences in costs and QALYs between NWpG and TAU groups were identified. The probability of NWpG being cost-effective compared to TAU was estimated below 75% for maximum willingness to pay (MWTP) values between 0 and 125,000 EUR. The additional provision of the NWpG package is not cost-effective compared to TAU alone.",2022,No significant differences in costs and QALYs between NWpG and TAU groups were identified.,"['Germany', '18 months, a total of 511 patients (NWpG = 251; TAU = 260']",['Integrated Mental Health Care Programme'],"['EQ-5D-3L and the Client Sociodemographic and Service Receipt Inventory (CSSRI', 'costs and QALYs']","[{'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517669', 'cui_str': '260'}]","[{'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",511.0,0.0411186,No significant differences in costs and QALYs between NWpG and TAU groups were identified.,"[{'ForeName': 'Annabel Sandra', 'Initials': 'AS', 'LastName': 'Mueller-Stierlin', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, 89312 Günzburg, Germany.'}, {'ForeName': 'Uemmueguelsuem', 'Initials': 'U', 'LastName': 'Dinc', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, 89312 Günzburg, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Herder', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, 89312 Günzburg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Walendzik', 'Affiliation': 'Schön Klinik MVZ GmbH, 81541 München, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schuetzwohl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Becker', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, 89312 Günzburg, Germany.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Kilian', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, 89312 Günzburg, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19116814']
1417,35684118,"Perioperative Administration of Cystine and Theanine Suppresses Inflammation and Facilitates Early Rehabilitation and Recovery after Esophagectomy: A Randomized, Double-Blind, Controlled Clinical Trial.","Oral administration of cystine and theanine (CT) increases glutathione levels to modulate the inflammatory response, which has yet to be sufficiently explored for patients' recovery and early rehabilitation. We planned a randomized, double-blind, placebo-controlled trial to determine whether perioperative oral administration of CT promotes recovery after esophagectomy. Patients were randomized into either CT or placebo groups, who received preoperative and postoperative treatments for 4 and 13 days, respectively. The main outcome measures were triaxial accelerometer readings, inflammation indicators, a 6 min walk test (6MWT), and a quality of life questionnaire (QoR-40). The study involved 32 patients. Although the CT group ( n  = 16) showed better patient activity across the investigated period, there was no significant difference between the two groups. However, white blood cell count on postoperative days (POD) 2 and 10, neutrophil count (POD 2, 7, and 10), and C-reactive protein level (POD 13) in the CT group were significantly lower than in the placebo group. Furthermore, 6MWT on POD 7 and QoR-40 on POD 13 were significantly higher in the CT group than those in the placebo group. This study suggests that perioperative administration of CT may contribute to early recovery and rehabilitation after esophagectomy via suppression of inflammatory response.",2022,"Furthermore, 6MWT on POD 7 and QoR-40 on POD 13 were significantly higher in the CT group than those in the placebo group.","['Esophagectomy', '32 patients']","['CT or placebo', 'cystine and theanine (CT', 'Cystine and Theanine', 'placebo', 'CT']","['POD 7 and QoR-40 on POD 13', 'triaxial accelerometer readings, inflammation indicators, a 6 min walk test (6MWT), and a quality of life questionnaire (QoR-40', 'glutathione levels', 'white blood cell count on postoperative days (POD) 2 and 10, neutrophil count (POD 2, 7, and 10), and C-reactive protein level (POD 13', 'patient activity']","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0076380', 'cui_str': 'theanine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",32.0,0.548262,"Furthermore, 6MWT on POD 7 and QoR-40 on POD 13 were significantly higher in the CT group than those in the placebo group.","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Taniyama', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Sakurai', 'Affiliation': 'Izumi Nomura Family Clinic, 1-5, Nomura Katsurashima-Higashi, Izumi-ku, Sendai 981-3124, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Kodama', 'Affiliation': 'Department of Rehabilitation, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Sato', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Fukutomi', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Ozawa', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Koseki', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'Department of Gastroenterologic and Hepato-Biliary-Pancreatic Surgery, Tohoku Medical and Pharmaceutical University, 1-12-1, Fukumuro, Miyagino-ku, Sendai 983-8512, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Unno', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kamei', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.'}]",Nutrients,['10.3390/nu14112319']
1418,35684041,"Photoprotective and Antiaging Effects of a Standardized Red Orange ( Citrus sinensis  (L.) Osbeck) Extract in Asian and Caucasian Subjects: A Randomized, Double-Blind, Controlled Study.","The increase in solar ultraviolet radiation (UVR) that reaches the Earth's surface should make us reflect on the need to develop new approaches in protecting the skin from UVR exposure. The present study aims to evaluate the photoprotective and antiaging efficacy of a red orange extract (100 mg/day) in both Asian and Caucasian subjects. A randomized, double-blind, controlled study was carried out in 110 Asian and Caucasian subjects. Product efficacy was measured as follows: (1) the photoprotective effect was measured by the minimal erythema dose (MED) assessment; (2) the efficacy in decreasing the UVA+B-induced skin redness was measured by colorimetry; (3) the antioxidant efficacy was measured by the ferric-reducing antioxidant power (FRAP) and the malondialdehyde (MDA) assay; and (4) skin moisturization, skin elasticity, skin radiance, the intensity of melanin staining, transepidermal water loss (TEWL), and wrinkles were measured to assess the antiaging efficacy. The intake of the product for 56 days was effective in improving the skin reaction to UV exposure; in increasing the skin antioxidant capacity as well as in decreasing UVA-induced lipid peroxidation; in increasing the skin moisturization, skin elasticity, and skin radiance; and in decreasing TEWL, the intensity of melanin staining inside dark spots, and wrinkle depth. Our results suggest that the test product is effective in counteracting both the harmful effects of UVR exposure and aging signs.",2022,"The intake of the product for 56 days was effective in improving the skin reaction to UV exposure; in increasing the skin antioxidant capacity as well as in decreasing UVA-induced lipid peroxidation; in increasing the skin moisturization, skin elasticity, and skin radiance; and in decreasing TEWL, the intensity of melanin staining inside dark spots, and wrinkle depth.","['Asian and Caucasian Subjects', 'Asian and Caucasian subjects', '110 Asian and Caucasian subjects']","['red orange extract', 'Standardized Red Orange ( Citrus sinensis  (L.) Osbeck) Extract']","['Product efficacy', 'photoprotective effect', 'skin moisturization, skin elasticity, and skin radiance', 'antioxidant efficacy', 'ferric-reducing antioxidant power (FRAP) and the malondialdehyde (MDA) assay; and (4) skin moisturization, skin elasticity, skin radiance, the intensity of melanin staining, transepidermal water loss (TEWL), and wrinkles', 'photoprotective and antiaging efficacy', 'solar ultraviolet radiation (UVR', 'UVA+B-induced skin redness']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C2702329', 'cui_str': 'orange allergenic extract'}, {'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C0522462', 'cui_str': 'Citrus sinensis'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",110.0,0.0710752,"The intake of the product for 56 days was effective in improving the skin reaction to UV exposure; in increasing the skin antioxidant capacity as well as in decreasing UVA-induced lipid peroxidation; in increasing the skin moisturization, skin elasticity, and skin radiance; and in decreasing TEWL, the intensity of melanin staining inside dark spots, and wrinkle depth.","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Nobile', 'Affiliation': 'R&D Department, Complife Italia S.r.l., 27028 San Martino Siccomario, PV, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Burioli', 'Affiliation': 'R&D Department, Complife Italia S.r.l., 27028 San Martino Siccomario, PV, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Clinical Study Department, Complife (Beijing) Testing Technology Co., Ltd., Beizhan North Street N.17, Room 902-Xicheng District, Beijing 100089, China.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Zhifeng', 'Affiliation': 'Clinical Study Department, Complife (Beijing) Testing Technology Co., Ltd., Beizhan North Street N.17, Room 902-Xicheng District, Beijing 100089, China.'}, {'ForeName': 'Enza', 'Initials': 'E', 'LastName': 'Cestone', 'Affiliation': 'R&D Department, Complife Italia S.r.l., 27028 San Martino Siccomario, PV, Italy.'}, {'ForeName': 'Violetta', 'Initials': 'V', 'LastName': 'Insolia', 'Affiliation': 'Active S.r.l., R&D Department, Piano Tavola, 95032 Belpasso, CT, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Zaccaria', 'Affiliation': 'Bionap S.r.l. R&D Department, Piano Tavola, 95032 Belpasso, CT, Italy.'}, {'ForeName': 'Giuseppe Antonio', 'Initials': 'GA', 'LastName': 'Malfa', 'Affiliation': 'Department of Drug and Health Science, University of Catania, Viale A. Doria, 95125 Catania, CT, Italy.'}]",Nutrients,['10.3390/nu14112241']
1419,35684034,The Impact of a Web-Based Lifestyle Educational Program ('Living Better') Reintervention on Hypertensive Overweight or Obese Patients.,"'Living Better', a self-administered web-based intervention, designed to facilitate lifestyle changes, has already shown positive short- and medium-term health benefits in patients with an obesity-hypertension phenotype. The objectives of this study were: (1) to examine the long-term (3-year) evolution of a group of hypertensive overweight or obese patients who had already followed the 'Living Better' program; (2) to analyze the effects of completing this program a second time (reintervention) during the COVID-19 pandemic. A quasi-experimental design was used. We recruited 29 individuals from the 105 who had participated in our first study. We assessed and compared their systolic and diastolic blood pressure (SBP and DBP), body mass index (BMI), eating behavior, and physical activity (PA) level (reported as METs-min/week), at Time 0 (first intervention follow-up), Time 1 (before the reintervention), and Time 2 (post-reintervention). Our results showed significant improvements between Time 1 and Time 2 in SBP (-4.7 (-8.7 to -0.7);  p  = 0.017), DBP (-3.5 (-6.2 to -0.8);  p  = 0.009), BMI (-0.7 (-1.0 to -0.4);  p  &lt; 0.001), emotional eating (-2.8 (-5.1 to -0.5);  p  = 0.012), external eating (-1.1 (-2.1 to -0.1);  p  = 0.039), and PA (Time 1: 2308 ± 2266; Time 2: 3203 ± 3314;  p  = 0.030, Z = -2.17). Statistical analysis showed no significant differences in SPB, DBP, BMI, and eating behavior between Time 0 and Time 1 ( p  &gt; 0.24). Implementation of the 'Living Better' program maintained positive long-term (3-year) health benefits in patients with an obesity-hypertension phenotype. Moreover, a reintervention with this program during the COVID-19 pandemic produced significant improvements in blood pressure, BMI, eating behavior, and PA.",2022,"Statistical analysis showed no significant differences in SPB, DBP, BMI, and eating behavior between Time 0 and Time 1 ( p  &gt; 0.24).","['patients with an obesity-hypertension phenotype', '29 individuals from the 105 who had participated in our first study', ""hypertensive overweight or obese patients who had already followed the 'Living Better' program; (2"", 'Hypertensive Overweight or Obese Patients']","[""Web-Based Lifestyle Educational Program ('Living Better"", ""Living Better' program maintained positive long-term (3-year) health benefits"", 'Reintervention']","['Time 1 and Time 2 in SBP', 'BMI', 'external eating', 'DBP', 'systolic and diastolic blood pressure (SBP and DBP), body mass index (BMI), eating behavior, and physical activity (PA) level', 'emotional eating', 'blood pressure, BMI, eating behavior, and PA', 'SPB, DBP, BMI, and eating behavior']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0597729', 'cui_str': 'Spindle Pole Body'}]",,0.0087607,"Statistical analysis showed no significant differences in SPB, DBP, BMI, and eating behavior between Time 0 and Time 1 ( p  &gt; 0.24).","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Múzquiz-Barberá', 'Affiliation': 'Department of Nursing and Physiotherapy, Faculty of Health Sciences, University CEU-Cardenal Herrera, CEU Universities, 46115 Valencia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ruiz-Cortés', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health Sciences, University CEU-Cardenal Herrera, CEU Universities, 46115 Valencia, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': 'Department of Psychology and Sociology, Universidad de Zaragoza, 50009 Teruel, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Vara', 'Affiliation': 'Centre of Physiopathology of Obesity and Nutrition (CIBERobn), CB06/03/0052, Instituto de Salud Carlos III, 46115 Valencia, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Escrivá-Martínez', 'Affiliation': 'Centre of Physiopathology of Obesity and Nutrition (CIBERobn), CB06/03/0052, Instituto de Salud Carlos III, 46115 Valencia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Carcelén', 'Affiliation': 'Department of Medicine and Surgery, Faculty of Health Sciences, University CEU-Cardenal Herrera, CEU Universities, 46115 Valencia, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Centre of Physiopathology of Obesity and Nutrition (CIBERobn), CB06/03/0052, Instituto de Salud Carlos III, 46115 Valencia, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Rodilla', 'Affiliation': 'Department of Medicine and Surgery, Faculty of Health Sciences, University CEU-Cardenal Herrera, CEU Universities, 46115 Valencia, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Lisón', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health Sciences, University CEU-Cardenal Herrera, CEU Universities, 46115 Valencia, Spain.'}]",Nutrients,['10.3390/nu14112235']
1420,35684031,"Consumption of Micronutrient Powder, Syrup or Fortified Food Significantly Improves Zinc and Iron Status in Young Mexican Children: A Cluster Randomized Trial.","The objective of this study was to compare the effect of three micronutrient products on biomarkers of iron and zinc status of Mexican children 6-12 months of age. As part of research to improve the impact of a national program, 54 communities were randomly assigned to receive: (1) fortified food (FF), provided by the program at the time, or (2) micronutrient powders (MNP) or (3) syrup. Each product contained 10 mg each of zinc and iron, plus other micronutrients. Children consumed the product 6 days/week for four months. Primary outcomes were changes in serum zinc, ferritin, soluble transferrin receptor, hemoglobin concentrations, and their deficiencies. Zinc concentration increased significantly from baseline to follow-up in all groups, with the largest change in the syrup group (geometric mean difference: +4.4 µmol/L; 95%CI: 3.2, 5.5), followed by MNP (+2.9 µmol/L; 95%CI: 2.1, 3.6) and FF (+0.9 µmol/L; 95%CI: 0.3, 1.6). There was a significant increase in hemoglobin concentration (+5.5 g/L; 2.5, 8.4) and a significant reduction in anemia prevalence (44.2% to 26.8%,  p  &lt; 0.01) only in the MNP group. Compliance differed significantly among groups (MNP vs. FF,  p  = 0.04; MNP vs. syrup,  p  = 0.04), but may not fully explain the greater improvement in zinc and iron status in the syrup and MNP groups. The food matrix may influence nutrient utilization from supplements.",2022,"Compliance differed significantly among groups (MNP vs. FF,  p  = 0.04; MNP vs. syrup,  p  = 0.04), but may not fully explain the greater improvement in zinc and iron status in the syrup and MNP groups.","['Young Mexican Children', 'Mexican children 6-12 months of age', '54 communities']","['fortified food (FF), provided by the program at the time, or (2) micronutrient powders (MNP) or (3) syrup', 'Micronutrient Powder, Syrup or Fortified Food']","['changes in serum zinc, ferritin, soluble transferrin receptor, hemoglobin concentrations, and their deficiencies', 'Zinc and Iron Status', 'hemoglobin concentration', 'zinc and iron status', 'Compliance', 'Zinc concentration', 'anemia prevalence', 'biomarkers of iron and zinc status']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",54.0,0.114824,"Compliance differed significantly among groups (MNP vs. FF,  p  = 0.04; MNP vs. syrup,  p  = 0.04), but may not fully explain the greater improvement in zinc and iron status in the syrup and MNP groups.","[{'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'García-Guerra', 'Affiliation': 'Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública (INSP), Universidad N-655, Colonia Santa María Ahuacatitlán, Cerrada los Pinos y Caminera, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Rivera', 'Affiliation': 'Centro de Investigación en Salud Poblacional, Instituto Nacional de Salud Pública (INSP), Universidad N-655, Colonia Santa María Ahuacatitlán, Cerrada los Pinos y Caminera, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Lynnette M', 'Initials': 'LM', 'LastName': 'Neufeld', 'Affiliation': 'Food and Agriculture Organization of the United Nations, 00153 Rome, Italy.'}, {'ForeName': 'Amado D', 'Initials': 'AD', 'LastName': 'Quezada-Sánchez', 'Affiliation': 'Centro de Investigación en Evaluación y Encuestas, Instituto Nacional de Salud Pública (INSP), Universidad N-655, Colonia Santa María Ahuacatitlán, Cerrada los Pinos y Caminera, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Dominguez Islas', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Vaccine and Infection Disease Division, 1100 Fairview Ave. N, Seattle, WA 98109, USA.'}, {'ForeName': 'Ana Cecilia', 'Initials': 'AC', 'LastName': 'Fernández-Gaxiola', 'Affiliation': 'Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública (INSP), Universidad N-655, Colonia Santa María Ahuacatitlán, Cerrada los Pinos y Caminera, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Anabelle', 'Initials': 'A', 'LastName': 'Bonvecchio Arenas', 'Affiliation': 'Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública (INSP), Universidad N-655, Colonia Santa María Ahuacatitlán, Cerrada los Pinos y Caminera, Cuernavaca 62100, Mexico.'}]",Nutrients,['10.3390/nu14112231']
1421,35684022,Effect of Dietary and Lifestyle Interventions on the Amelioration of NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study.,"BACKGROUND


Adults with fatty liver present unusual glycaemia and lipid metabolism; as a result, non-alcoholic fatty liver disease (NAFLD) is now considered as part of the metabolic syndrome (MetS).
OBJECTIVE


To assess the 6- and 12-month effects of customized hypocaloric dietary and enhanced physical activity intervention on intrahepatic fat contents and progression of NAFLD, in patients with MetS.
DESIGN


Cross-sectional study in 155 participants (40-60 years old) from Balearic Islands and Navarra (Spain) with a diagnosis of NAFLD and MetS, and BMI (body mass index) between 27 and 40 kg/m 2 ; patients were randomized in a 1:1:1 ratio to either Conventional Diet, Mediterranean diet (MD)-high meal frequency, and MD-physical activity groups.
METHODS


Dietary intake was assessed using a validated food frequency questionnaire. Adherence to Mediterranean diet, anthropometrics, physical activity, and biochemical parameters (fasting glucose, glycated hemoglobin, bilirubin, aspartate aminotransferase, alanine aminotransferase-ALT-, gamma-glutamyl transferase, uric acid, urea, creatinine, albumin, total cholesterol, high-density lipoprotein cholesterol-HDL-cholesterol-, and triglycerides) were also assessed.
RESULTS


Subjects with NAFLD and MetS had reduced intrahepatic fat contents, and liver stiffness, despite the intervention the participants went through. All participants ameliorated BMI, insulin, Hb1Ac, diastolic blood pressure, HDL-cholesterol, and ALT, and improved consumption of total energy, fish, and legumes. Participants in the MD-HMF group improved waist circumference.
CONCLUSIONS


Customized hypocaloric dietary and enhanced physical activity interventions may be useful to ameliorate NAFLD.",2022,"All participants ameliorated BMI, insulin, Hb1Ac, diastolic blood pressure, HDL-cholesterol, and ALT, and improved consumption of total energy, fish, and legumes.","['patients with MetS.\nDESIGN\n\n\nCross-sectional study in 155 participants (40-60 years old) from Balearic Islands and Navarra (Spain) with a diagnosis of NAFLD and MetS, and BMI (body mass index) between 27 and 40 kg/m 2 ; patients', 'Adults with fatty liver present unusual glycaemia and lipid metabolism', 'Patients with Metabolic Syndrome']","['Conventional Diet, Mediterranean diet (MD)-high meal frequency, and MD-physical activity groups', 'customized hypocaloric dietary and enhanced physical activity intervention', 'Dietary and Lifestyle Interventions']","['Amelioration of NAFLD', 'BMI, insulin, Hb1Ac, diastolic blood pressure, HDL-cholesterol, and ALT, and improved consumption of total energy, fish, and legumes', 'intrahepatic fat contents, and liver stiffness', 'Adherence to Mediterranean diet, anthropometrics, physical activity, and biochemical parameters (fasting glucose, glycated hemoglobin, bilirubin, aspartate aminotransferase, alanine aminotransferase-ALT-, gamma-glutamyl transferase, uric acid, urea, creatinine, albumin, total cholesterol, high-density lipoprotein cholesterol-HDL-cholesterol-, and triglycerides', 'waist circumference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0023263', 'cui_str': 'Pea family'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",155.0,0.0442158,"All participants ameliorated BMI, insulin, Hb1Ac, diastolic blood pressure, HDL-cholesterol, and ALT, and improved consumption of total energy, fish, and legumes.","[{'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Montemayor', 'Affiliation': 'Research Group on Community Nutrition and Oxidative Stress, University of the Balearic Islands-IUNICS, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bouzas', 'Affiliation': 'Research Group on Community Nutrition and Oxidative Stress, University of the Balearic Islands-IUNICS, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Catalina M', 'Initials': 'CM', 'LastName': 'Mascaró', 'Affiliation': 'Research Group on Community Nutrition and Oxidative Stress, University of the Balearic Islands-IUNICS, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Casares', 'Affiliation': 'Radiodiagnosis Service, Red Asistencial Juaneda, 07011 Palma de Mallorca, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Llompart', 'Affiliation': 'Research Group on Community Nutrition and Oxidative Stress, University of the Balearic Islands-IUNICS, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Abete', 'Affiliation': 'CIBEROBN (Physiopathology of Obesity and Nutrition CB12/03/30038), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Escarlata', 'Initials': 'E', 'LastName': 'Angullo-Martinez', 'Affiliation': 'Research Group on Community Nutrition and Oxidative Stress, University of the Balearic Islands-IUNICS, 07122 Palma de Mallorca, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Zulet', 'Affiliation': 'CIBEROBN (Physiopathology of Obesity and Nutrition CB12/03/30038), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'Research Group on Community Nutrition and Oxidative Stress, University of the Balearic Islands-IUNICS, 07122 Palma de Mallorca, Spain.'}]",Nutrients,['10.3390/nu14112223']
1422,35684021,"A Combination of Nicotinamide and D-Ribose (RiaGev) Is Safe and Effective to Increase NAD +  Metabolome in Healthy Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled, Cross-Over Pilot Clinical Trial.","Nicotinamide adenine dinucleotide (NAD + ) is an essential cofactor required for proper functioning of all cells and its decline is correlated with advancing age and disease. This randomized, triple-blind, placebo-controlled, crossover pilot study assessed the efficacy and safety of a combination of nicotinamide with D-ribose (RiaGev) for NAD metabolome enhancement and related benefits in healthy middle-aged adults. Supplementing with 1520 mg RiaGev twice daily for 7 days significantly increased the NAD +  metabolome in blood, especially NADP +  by 27% compared to the placebo group ( p  = 0.033) and over the baseline ( p  = 0.007). Increases in glutathione and high energy phosphates were also observed in the blood. Seven-day supplementation with RiaGev significantly ( p  = 0.013) reduced overall blood glucose without significant changes in insulin secretion ( p  = 0.796), suggesting an improved insulin sensitivity and glucose tolerance. The waking salivary cortisol of the subjects steadily and significantly decreased ( p  = 0.026) in the RiaGev group in contrast to the placebo. Subjects in the RiaGev group showed less fatigue, improved mental concentration and motivation over the baseline ( p  = 0.015, 0.018, and 0.012, respectively) as observed through the Checklist Individual Strength (CIS) questionnaire. There were no clinically relevant adverse events, or alterations in hematology, electrolytes, liver, and kidney markers pre- and post-supplementation. RiaGev appears to be safe and efficacious in increasing NAD +  metabolome in healthy middle-aged adults, as shown by this study.",2022,"Seven-day supplementation with RiaGev significantly ( p  = 0.013) reduced overall blood glucose without significant changes in insulin secretion ( p  = 0.796), suggesting an improved insulin sensitivity and glucose tolerance.","['healthy middle-aged adults', 'Healthy Middle-Aged Adults']","['nicotinamide with D-ribose (RiaGev', 'Nicotinamide adenine dinucleotide (NAD + ', 'NAD +  Metabolome', 'Nicotinamide and D', 'placebo', 'Placebo']","['NAD +  metabolome in blood, especially NADP ', 'glutathione and high energy phosphates', 'efficacy and safety', 'adverse events, or alterations in hematology, electrolytes, liver, and kidney markers pre- and post-supplementation', 'insulin secretion', 'insulin sensitivity and glucose tolerance', 'Checklist Individual Strength (CIS) questionnaire', 'overall blood glucose', 'waking salivary cortisol', 'fatigue, improved mental concentration and motivation']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0035549', 'cui_str': 'Ribose'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0027303', 'cui_str': 'Nicotinamide adenine dinucleotide phosphate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0721307,"Seven-day supplementation with RiaGev significantly ( p  = 0.013) reduced overall blood glucose without significant changes in insulin secretion ( p  = 0.796), suggesting an improved insulin sensitivity and glucose tolerance.","[{'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Bioenergy Life Science, Inc., Ham Lake, MN 55304, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Shamp', 'Affiliation': 'Prism Clinical Research Institute, Saint Paul, MN 55114, USA.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Nagana Gowda', 'Affiliation': 'Northwest Metabolomics Research Center, University of Washington, Seattle, WA 98109, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Crabtree', 'Affiliation': 'Bioenergy Life Science, Inc., Ham Lake, MN 55304, USA.'}, {'ForeName': 'Debasis', 'Initials': 'D', 'LastName': 'Bagchi', 'Affiliation': 'College of Pharmacy and Health Sciences, Texas Southern University, Houston, TX 77004, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Northwest Metabolomics Research Center, University of Washington, Seattle, WA 98109, USA.'}]",Nutrients,['10.3390/nu14112219']
1423,35684003,Fermented  Carica papaya  and  Morinda citrifolia  as Perspective Food Supplements for the Treatment of Post-COVID Symptoms: Randomized Placebo-Controlled Clinical Laboratory Study.,"Food supplements based on fermented  Carica papaya  and  Morinda citrifolia , known for their immune modulating, redox balancing, and anti-inflammatory effects, were added to conventional treatment protocols prescribed to patients recovering after severe and moderate COVID-19 disease in order to alleviate long-lasting post-COVID symptoms. A randomized single-center placebo-controlled clinical laboratory study was designed and performed (total number of participants 188, with delta variant of virus 157, with omicron 31). Clinical statuses were assessed using computer tomography, electrocardiography, a questionnaire, and physical endurance. Plasma cytokines (IL-6, IL-8, IL-17A, and INF-gamma), nitrate/nitrite ratio, antioxidant activity (AOA), and polymorphonuclear leukocyte (PMN) ATP levels were determined before and 20 days following the addition of 28 g of fermented supplements twice per day. The capacity of PMN to phagocyte and the oral-nasal-pharyngeal microbiota were assessed. Clinical symptoms, IL-6, IL-8, and nitric oxide metabolites diminished significantly compared to the placebo group and their background expression. The PMN capacity to phagocyte, AOA, and ATP content remarkably increased. The oral-nasal-pharyngeal microbiota were unchanged. On these grounds, we suggest that fermented tropical fruits could efficiently diminish post-COVID clinical symptoms through several immune-modulating, redox balancing, and pro-energy mechanisms.",2022,"Clinical symptoms, IL-6, IL-8, and nitric oxide metabolites diminished significantly compared to the placebo group and their background expression.","['participants 188, with delta variant of virus 157, with omicron 31']","['placebo', 'Placebo']","['Plasma cytokines (IL-6, IL-8, IL-17A, and INF-gamma), nitrate/nitrite ratio, antioxidant activity (AOA), and polymorphonuclear leukocyte (PMN', 'PMN capacity to phagocyte, AOA, and ATP content', 'Clinical symptoms, IL-6, IL-8, and nitric oxide metabolites', 'ATP levels', 'capacity of PMN to phagocyte and the oral-nasal-pharyngeal microbiota']","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C1720076', 'cui_str': 'Omicron'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0031307', 'cui_str': 'Phagocytic cell'}, {'cui': 'C1859598', 'cui_str': 'Early-onset ataxia with oculomotor apraxia and hypoalbuminemia'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",188.0,0.182366,"Clinical symptoms, IL-6, IL-8, and nitric oxide metabolites diminished significantly compared to the placebo group and their background expression.","[{'ForeName': 'Zaira', 'Initials': 'Z', 'LastName': 'Kharaeva', 'Affiliation': ""Microbiology, Immunology, and Virology Department, Kabardino-Balkar Berbekov's State University, 360022 Nal'chik, Russia.""}, {'ForeName': 'Albina', 'Initials': 'A', 'LastName': 'Shokarova', 'Affiliation': ""COVID Unit, Rehabilitation Centre, State Hospital N1, 360022 Nal'chik, Russia.""}, {'ForeName': 'Zalina', 'Initials': 'Z', 'LastName': 'Shomakhova', 'Affiliation': ""COVID Unit, Rehabilitation Centre, State Hospital N1, 360022 Nal'chik, Russia.""}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Ibragimova', 'Affiliation': 'Centre for Innovative Biotechnological Investigations Nanolab (CIBI-NANOLAB), 117437 Moscow, Russia.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Trakhtman', 'Affiliation': 'Blood Bank, Federal Centre for Paediatric Haematology, Oncology and Immunology, 117437 Moscow, Russia.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Trakhtman', 'Affiliation': 'R&D, Swiss DEKOTRA Ltd., CH-8048 Zurich, Switzerland.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Chung', 'Affiliation': 'R&D, Natural Health Farm, Shah Alam 40150, Selangor, Malaysia.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Mayer', 'Affiliation': 'R&D, Medena AGAffoltern-am-Albis, CH-8910 Zurich, Switzerland.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'De Luca', 'Affiliation': 'R&D, Medena AGAffoltern-am-Albis, CH-8910 Zurich, Switzerland.'}, {'ForeName': 'Liudmila', 'Initials': 'L', 'LastName': 'Korkina', 'Affiliation': 'Centre for Innovative Biotechnological Investigations Nanolab (CIBI-NANOLAB), 117437 Moscow, Russia.'}]",Nutrients,['10.3390/nu14112203']
1424,35683992,"Resistant Maltodextrin Consumption in a Double-Blind, Randomized, Crossover Clinical Trial Induces Specific Changes in Potentially Beneficial Gut Bacteria.","BACKGROUND


We have previously reported that the addition of resistant maltodextrin (RMD), a fermentable functional fiber, to the diet increases fecal weight as well as the amount of fecal bifidobacteria. Here, we report on the targeted analysis of changes in potentially beneficial gut bacteria associated with the intervention.
OBJECTIVE


The primary objective of this study was to determine the effect of adding 0, 15 and 25 g RMD to the diets of healthy free-living adults on potentially beneficial gut bacteria.
METHODS


We expanded on our previously reported microbiota analysis in a double-blind, placebo-controlled feeding study (NCT02733263) by performing additional qPCR analyses targeting fecal lactic acid bacteria (LAB),  Akkermansia muciniphila ,  Faecalibacterium prausnitzii  and  Fusicatenibacter saccharivorans  in samples from 49 participants.
RESULTS


RMD resulted in an approximately two-fold increase in fecal  Fusicatenibacter saccharivorans  ( p  = 0.024 for 15 g/day RMD and  p  = 0.017 for 25 g/day RMD). For  Akkermansia muciniphila  and  Faecalibacterium prausnitzii,  we obtained borderline evidence that showed increased amounts in participants that had low baseline levels of these bacteria ( p  &lt; 0.1 for 25 g/day RMD). We did not detect any effects of RMD on LAB.
CONCLUSIONS


RMD supplementation in healthy individuals increases  Fusicatenibacter saccharivorans.  Albeit to a lesser extent, RMD at the higher intake level may also increase  Akkermansia muciniphila  and  Faecalibacterium prausnitzii  in individuals with low baseline levels of those two species. Potential benefits associated with these microbiota changes remain to be established in studies with quantifiable health-related endpoints.",2022,"RESULTS


RMD resulted in an approximately two-fold increase in fecal  Fusicatenibacter saccharivorans  ( p  = 0.024 for 15 g/day RMD and  p  = 0.017 for 25 g/day RMD).","['individuals with low baseline levels of those two species', 'healthy individuals', 'healthy free-living adults', 'samples from 49 participants']","['RMD supplementation', 'Resistant Maltodextrin Consumption', 'resistant maltodextrin (RMD', 'placebo']","['fecal weight', 'fecal  Fusicatenibacter saccharivorans']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",49.0,0.436699,"RESULTS


RMD resulted in an approximately two-fold increase in fecal  Fusicatenibacter saccharivorans  ( p  = 0.024 for 15 g/day RMD and  p  = 0.017 for 25 g/day RMD).","[{'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Mai', 'Affiliation': 'Department of Epidemiology, Emerging Pathogens Institute, University of Florida, Gainesville, FL 32610, USA.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Burns', 'Affiliation': 'Food Science and Human Nutrition Department, University of Florida, 572 Newell Drive, Gainesville, FL 32611, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Solch', 'Affiliation': 'Food Science and Human Nutrition Department, University of Florida, 572 Newell Drive, Gainesville, FL 32611, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Dennis-Wall', 'Affiliation': 'Department of Epidemiology, Emerging Pathogens Institute, University of Florida, Gainesville, FL 32610, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ukhanova', 'Affiliation': 'Department of Epidemiology, Emerging Pathogens Institute, University of Florida, Gainesville, FL 32610, USA.'}, {'ForeName': 'Bobbi', 'Initials': 'B', 'LastName': 'Langkamp-Henken', 'Affiliation': 'Department of Epidemiology, Emerging Pathogens Institute, University of Florida, Gainesville, FL 32610, USA.'}]",Nutrients,['10.3390/nu14112192']
1425,35683991,The Efficacy of Fish as an Early Complementary Food on the Linear Growth of Infants Aged 6-7 Months: A Randomised Controlled Trial.,"Fish is a good animal-source protein for growth and development. The main objective of the study was to assess the efficacy of fish during the early complementary feeding period on infants' linear growth in the Samfya district of the Luapula Province of Zambia in 6 months randomised controlled trial. The study was conducted from April 2019 to January 2020. Infants aged 6-7 months ( N  = 238) were assigned to either the intervention (treatment) group or control (placebo) group to receive fish powder or sorghum powder, respectively. Participants were followed on a weekly basis to distribute the powder and record compliance/usage and any morbidities. Anthropometric measurements were taken monthly. A linear mixed-effects model showed that fish powder improved linear growth among infants over all the 6 months of the intervention period. The fish powder increased length-for-age z scores by 1.26 (95% CI: 0.94-1.57) and weight-for-age z score by 0.95 (95% CI 0.6-1.23). The addition of fish powder to the infant's usual food during the early complementary feeding improves the infant's linear growth outcome.",2022,A linear mixed-effects model showed that fish powder improved linear growth among infants over all the 6 months of the intervention period.,"['Infants aged 6-7 months ( N  = 238', 'Aged 6-7 Months', 'Infants', 'April 2019 to January 2020', ""infants' linear growth in the Samfya district of the Luapula Province of Zambia in 6 months""]",['intervention (treatment) group or control (placebo) group to receive fish powder or sorghum powder'],"['linear growth', 'length-for-age z scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0331570', 'cui_str': 'Genus Sorghum'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",238.0,0.169846,A linear mixed-effects model showed that fish powder improved linear growth among infants over all the 6 months of the intervention period.,"[{'ForeName': 'Given', 'Initials': 'G', 'LastName': 'Chipili', 'Affiliation': 'Department of Nutritional Sciences, Mukuba University, Itimpi, Off Chingola Road, P.O. Box 20382, Kitwe 50100, Zambia.'}, {'ForeName': 'Averalda', 'Initials': 'A', 'LastName': 'Van Graan', 'Affiliation': 'Division of Human Nutrition, Faculty of Medicine and Health Sciences, Stellenbosch University, Francie Van Zijl Drive, Tygerberg 7505, Cape Town P.O. Box 19063, South Africa.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Lombard', 'Affiliation': 'Division of Biostatistics, Faculty of Medicine and Health Sciences, Stellenbosch University, Francie Van Zijl Drive, Tygerberg 7505, Cape Town P.O. Box 19063, South Africa.'}, {'ForeName': 'Evette', 'Initials': 'E', 'LastName': 'Van Niekerk', 'Affiliation': 'Division of Human Nutrition, Faculty of Medicine and Health Sciences, Stellenbosch University, Francie Van Zijl Drive, Tygerberg 7505, Cape Town P.O. Box 19063, South Africa.'}]",Nutrients,['10.3390/nu14112191']
1426,35683988,"Secondary Outcomes of a Front-of-Pack-Labelling Randomised Controlled Experiment in a Representative British Sample: Understanding, Ranking Speed and Perceptions.","Front-of-pack labels (FOPLs) provide simplified nutritional information that aims to inform consumer choice and encourage reformulation. We conducted an online randomised controlled experiment on a representative British sample to test the effectiveness of FOPLs across a range of outcomes. The primary outcomes have been published; here, we present the secondary outcomes: the ability to rank the healthiest product and the time to complete the rankings by comparing the FOPL groups and a no-label control, as well as a descriptive analysis of the perceptions. Participants from the NatCen panel were randomised to one of five experimental groups (Multiple Traffic Lights; Nutri-Score; Warning Label; Positive Choice tick; no-label control). Six food/drink categories were selected (pizza, drinks, cakes, crisps, yoghurts, breakfast cereals), and three products were created with varying healthiness. The participants (analytic sample = 4530) were asked to rank the products in order of healthiness twice (baseline: no label; follow-up: experimental group label). Compared to the control, the probability of correctly ranking the healthiest product at follow-up was significantly greater for the N-S, MTL and WL across all products. The time to correctly complete the ranking was fastest for the N-S, PC and no-label control. The descriptive analysis showed that the FOPLs were perceived favourably, and especially N-S and MTL. The findings were supportive of the primary analyses, with those results suggesting that N-S performed the best, and then MTL.",2022,"Compared to the control, the probability of correctly ranking the healthiest product at follow-up was significantly greater for the N-S, MTL and WL across all products.",['Participants from the NatCen panel'],['five experimental groups (Multiple Traffic Lights; Nutri-Score; Warning Label; Positive Choice tick; no-label control'],"['ability to rank the healthiest product and the time to complete the rankings', 'Representative British Sample: Understanding, Ranking Speed and Perceptions']","[{'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0040203', 'cui_str': 'Ixodida'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",4530.0,0.171491,"Compared to the control, the probability of correctly ranking the healthiest product at follow-up was significantly greater for the N-S, MTL and WL across all products.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Packer', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, University College London, London WC1N 1EH, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Russell', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, University College London, London WC1N 1EH, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ridout', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, University College London, London WC1N 1EH, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Conolly', 'Affiliation': 'National Center for Social Research, London EC1V 0AX, UK.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Jessop', 'Affiliation': 'National Center for Social Research, London EC1V 0AX, UK.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Viner', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, University College London, London WC1N 1EH, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Croker', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, University College London, London WC1N 1EH, UK.'}]",Nutrients,['10.3390/nu14112188']
1427,35683985,"Wasting, Stunting, and Anemia in Angolan Children after Deworming with Albendazole or a Test-and-Treat Approach for Intestinal Parasites: Binary Longitudinal Models with Temporal Structure in a Four-Arm Randomized Trial.","Undernutrition, anemia, and intestinal parasitic infections are public health problems in Angola, especially in pre-school children. We analyzed binary data from a longitudinal four-arm randomized parallel trial conducted in Bengo Province, northern Angola, over the course of two years, with seven follow-up assessments to explore the effects of four interventions (deworming and a test-and-treat approach for intestinal parasites, at both the individual and household levels) on wasting and stunting, and to understand their indirect benefits for anemia, malaria, diarrhea, and vomiting. A total of 121 children with intestinal parasitic infections received baseline treatment, and were allocated to the four arms (1:1:1:1). Using continuous outcome variables of height-for-age (HAZ) and weight-for-height (WHZ) statistical approaches did not reveal a clear benefit of any particular arm (Pathogens 2021, 10, 309). Next, HAZ and WHZ were transformed into binary variables of stunting and wasting, respectively, considering their mild-to-severe (Z-score &lt; -1) and moderate-to-severe degrees (Z-score &lt; -2). Original clinical data (on anemia, diarrhea, vomiting, and malaria) were also analyzed. From a binary longitudinal analysis with different dependence structures, using the R package  bild , fitted models revealed the potential benefit of a test-and-treat approach at the individual level for wasting compared with annual albendazole at the individual level, especially considering mild-to-severe forms (OR adj  = 0.27;  p  = 0.007). All arms showed similar effects on stunting, compared with annual albendazole, at a 5% significance level. Time and age at baseline presented favorable effects in the percentage of stunting using both severity degrees. Results showed a decreased chance of having anemia and diarrhea over time, although with no significant differences between arms. Data from longitudinal studies are essential to study the direct and indirect effects of interventions, such as deworming, and to explore additional approaches aiming at better understanding the temporal structure of nutrition and health outcomes in children.",2022,"All arms showed similar effects on stunting, compared with annual albendazole, at a 5% significance level.","['children', '121 children with intestinal parasitic infections', 'Intestinal Parasites']","['Albendazole', 'albendazole']","['Undernutrition, anemia, and intestinal parasitic infections', 'Original clinical data (on anemia, diarrhea, vomiting, and malaria', 'Wasting, Stunting, and Anemia', 'anemia, malaria, diarrhea, and vomiting', 'chance of having anemia and diarrhea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021832', 'cui_str': 'Intestinal parasitism'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0021832', 'cui_str': 'Intestinal parasitism'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",121.0,0.142141,"All arms showed similar effects on stunting, compared with annual albendazole, at a 5% significance level.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Gasparinho', 'Affiliation': 'Centro de Investigação em Saúde de Angola (CISA), Rua Direita de Caxito, Caxito, Angola.'}, {'ForeName': 'Maria Helena', 'Initials': 'MH', 'LastName': 'Gonçalves', 'Affiliation': 'Departamento de Matemática, Faculdade de Ciências e Tecnologia, Universidade do Algarve, 8005-139 Faro, Portugal.'}, {'ForeName': 'Assucênio', 'Initials': 'A', 'LastName': 'Chissaque', 'Affiliation': 'Global Health and Tropical Medicine (GHTM), Instituto de Higiene e Medicina Tropical (IHMT), Universidade Nova de Lisboa (UNL), 1349-008 Lisbon, Portugal.'}, {'ForeName': 'Giovani L', 'Initials': 'GL', 'LastName': 'Silva', 'Affiliation': 'Centro de Estatística e Aplicações da Universidade de Lisboa (CEAUL), Faculdade de Ciências da Universidade de Lisboa, 1749-016 Lisbon, Portugal.'}, {'ForeName': 'Filomeno', 'Initials': 'F', 'LastName': 'Fortes', 'Affiliation': 'Global Health and Tropical Medicine (GHTM), Instituto de Higiene e Medicina Tropical (IHMT), Universidade Nova de Lisboa (UNL), 1349-008 Lisbon, Portugal.'}, {'ForeName': 'Luzia', 'Initials': 'L', 'LastName': 'Gonçalves', 'Affiliation': 'Global Health and Tropical Medicine (GHTM), Instituto de Higiene e Medicina Tropical (IHMT), Universidade Nova de Lisboa (UNL), 1349-008 Lisbon, Portugal.'}]",Nutrients,['10.3390/nu14112185']
1428,35683982,Efficacy of a New Low-Protein Multimedia Diet App for PKU.,"Patients with phenylketonuria (PKU) require a phenylalanine/protein-restricted diet, with limited food choice. Interpreting food labels, calculating protein intake, and determining food suitability are complex and confusing tasks. A mobile multi-media low-protein diet app was developed to guide food choice, label interpretation, and protein calculation. ' PKU Bite ' ®  includes &gt;1100 specialist and regular low-protein foods, is colour-coded for suitability, and features a protein calculator. A 12-week randomised controlled trial assessed app efficacy, compared with written/pictorial material, in 60 parents/caregivers of children with PKU, aged 1-16 years, and 21 adolescents with PKU. Questionnaires examined self-efficacy and label-reading knowledge; food records evaluated natural-protein intake, compared with prescriptions. There was no difference between groups in label-reading knowledge or self-efficacy, but there was a trend for improved accuracy of dietary protein calculation, when using the app (baseline/12-weeks: app 35%/48%; control 39%/35%). Parents of children &lt;10 years of age (median 5.5 years), were most likely to use the app to check the phenylalanine/protein content of a food or to verify suitability of foods. Whilst the app was popular (43%), so too was contacting the dietitian (43%), using written/pictorial information (24%), or using social media (18%). This is the first dietary app for PKU to be studied in a systematic way as well as validated by healthcare professionals. It is a useful adjunct to existing resources and will be a valuable tool for educating parents of younger children.",2022,"There was no difference between groups in label-reading knowledge or self-efficacy, but there was a trend for improved accuracy of dietary protein calculation, when using the app (baseline/12-weeks: app 35%/48%; control 39%/35%).","['Patients with phenylketonuria (PKU) require a phenylalanine/protein-restricted diet, with limited food choice', '60 parents/caregivers of children with PKU, aged 1-16 years, and 21 adolescents with PKU', 'Parents of children &lt;10 years of age (median 5.5 years', 'educating parents of younger children']","['New Low-Protein Multimedia Diet App', 'written/pictorial material']","['accuracy of dietary protein calculation', 'label-reading knowledge or self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",60.0,0.0258658,"There was no difference between groups in label-reading knowledge or self-efficacy, but there was a trend for improved accuracy of dietary protein calculation, when using the app (baseline/12-weeks: app 35%/48%; control 39%/35%).","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': ""Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham B4 6NH, UK.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ashmore', 'Affiliation': ""Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham B4 6NH, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daly', 'Affiliation': ""Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham B4 6NH, UK.""}, {'ForeName': 'Perninder', 'Initials': 'P', 'LastName': 'Dhadwar', 'Affiliation': 'Imobisoft, The Technocenter, Coventry University Technology Park Puma Way, Coventry CV1 2TT, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Syed', 'Affiliation': 'Imobisoft, The Technocenter, Coventry University Technology Park Puma Way, Coventry CV1 2TT, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Lecocq', 'Affiliation': ""Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham B4 6NH, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Brownlow Hill, Liverpool L69 3GL, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': ""Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham B4 6NH, UK.""}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'MacDonald', 'Affiliation': ""Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham B4 6NH, UK.""}]",Nutrients,['10.3390/nu14112182']
1429,35684157,"Effects of Five Amino Acids (Serine, Alanine, Glutamate, Aspartate, and Tyrosine) on Mental Health in Healthy Office Workers: A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial.","BACKGROUND


The importance of maintaining good mental health with overall well-being has recently drawn attention from various spheres of academics and the working population. Amino acid intake has been reported to reduce depression symptoms and other mental health problems. However, the effectiveness of amino acid intake (i.e., single or combined) remains unknown. In this study, we assessed a combination of five amino acids (serine, alanine, glutamate, aspartate, and tyrosine; SAGAT) reported to regulate mental health.
METHODS


A randomized, double-blind, placebo-controlled exploratory trial was conducted. Participants, aged between 20 and 65 years with fatigue sensation, were randomized to receive either SAGAT or the placebo and ingested them for four weeks. A transient mental work was loaded at day 0 and after four weeks of intervention. As the primary outcomes, the fatigue sensation was assessed. The mood status, cognitive function, work efficiency, and blood marker were also measured as secondary outcomes.
RESULTS


The number of participants analyzed for the efficacy evaluation were 20 in SAGAT and 22 in the placebo. There were no significant differences in the primary outcomes. However, as the secondary outcomes, the SAGAT group showed a significant improvement in motivation and cognitive function in the recovery period after mental work loaded in a four-week intervention compared to the placebo.
CONCLUSION


The current findings suggest that SAGAT contributes to maintaining proper motivation and cognitive function.
CLINICAL TRIAL REGISTRATION


University Hospital Medical Information Network Clinical Trial Registry (ID: UMIN 000041221).",2022,There were no significant differences in the primary outcomes.,"['Participants, aged between 20 and 65 years with fatigue sensation', 'Healthy Office Workers']","['five amino acids (serine, alanine, glutamate, aspartate, and tyrosine; SAGAT', 'Five Amino Acids (Serine, Alanine, Glutamate, Aspartate, and Tyrosine', 'SAGAT', 'placebo', 'Placebo']","['motivation and cognitive function', 'mood status, cognitive function, work efficiency, and blood marker', 'fatigue sensation']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.846991,There were no significant differences in the primary outcomes.,"[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Umeda', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shindo', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Somekawa', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Nishitani', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Sato', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Sakiko', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Sachise', 'Initials': 'S', 'LastName': 'Karakawa', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Kawasaki', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc., Kawasaki 210-8681, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Mine', 'Affiliation': 'Research & Business Planning Department, Ajinomoto Co., Inc., Tokyo 104-8315, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki 210-8681, Japan.'}]",Nutrients,['10.3390/nu14112357']
1430,35684150,Patterns and Predictors of Breast Milk Feeding from Birth to Age 4 Months among Primiparous African American Mother-Infant Dyads.,"The health benefits of breast milk feeding have been well-established, yet disparities exist, with African American mothers having the lowest breast milk feeding rates in the United States. This prospective, longitudinal study examined infant feeding (breast milk and/or infant formula) from birth to age 16 weeks, predictors of any breast milk feeding by age 1 week, and predictors of cessation of any breast milk feeding by ages 3, 8, and 16 weeks among primiparous African American mothers. This secondary analysis included 185 mother-infant dyads from the Sleep SAAF (Strong African American Families) study, a randomized clinical trial testing a responsive parenting vs. child safety control intervention. Mothers reported sociodemographic and psychosocial characteristics at age 1 week and infant feeding practices at ages 1, 3, 8, and 16 weeks. Rates of any breast milk feeding decreased from 66.5% at 1 week to 23.3% at 16 weeks. Bivariate logistic regression models showed that prepregnancy BMI (OR = 1.09), working prepregnancy (OR = 2.25), and food insecurity (OR = 2.49) significantly increased the odds of mothers feeding any breast milk by 1 week, whereas Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) participation (OR = 0.21) significantly decreased the odds. Bivariate logistic regression models showed that Supplemental Nutrition Assistance Program (SNAP) participation (OR = 2.86) and racial discrimination (OR = 2.14) significantly increased the odds of cessation of any breast milk feeding by 3 weeks. SNAP (OR = 2.33) and WIC (OR = 2.38) participation significantly increased the odds of cessation of any breast milk feeding by 8 weeks, whereas higher prepregnancy BMI (OR = 0.95) decreased the odds. Higher mother's age (OR = 0.92) significantly decreased the odds of cessation of any breast milk feeding by 16 weeks. The findings can be used to inform targeted interventions to promote mothers feeding any breast milk and help reduce breast milk feeding disparities among African American mothers.",2022,Higher mother's age (OR = 0.92) significantly decreased the odds of cessation of any breast milk feeding by 16 weeks.,"['Primiparous African American Mother-Infant Dyads', 'infant feeding (breast milk and/or infant formula) from birth to age 16 weeks, predictors of any breast milk feeding by age 1 week, and predictors of cessation of any breast milk feeding by ages 3, 8, and 16 weeks among primiparous African American mothers', '185 mother-infant dyads from the Sleep SAAF (Strong African American Families', 'African American mothers']",['responsive parenting vs. child safety control intervention'],"['working prepregnancy', 'Rates of any breast milk feeding', 'odds of cessation of any breast milk feeding', 'prepregnancy BMI']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",185.0,0.00628212,Higher mother's age (OR = 0.92) significantly decreased the odds of cessation of any breast milk feeding by 16 weeks.,"[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Moore', 'Affiliation': 'Center for Childhood Obesity Research, The Pennsylvania State University, 129 Noll Laboratory, University Park, PA 16802, USA.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Smith', 'Affiliation': 'Center for Family Research, University of Georgia, Athens, GA 30602, USA.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Stansfield', 'Affiliation': 'Department of Pediatrics, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, The Pennsylvania State University, 129 Noll Laboratory, University Park, PA 16802, USA.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Lavner', 'Affiliation': 'Department of Psychology, University of Georgia, 156 Psychology Building, Athens, GA 30602, USA.'}]",Nutrients,['10.3390/nu14112350']
1431,35684144,Randomized Clinical Trial: Effects of β-Hydroxy-β-Methylbutyrate (HMB)-Enriched vs. HMB-Free Oral Nutritional Supplementation in Malnourished Cirrhotic Patients.,"β-Hydroxy-β-methylbutyrate (HMB) supplementation increases muscle and strength mass in some muscle-wasting disorders. Malnutrition and sarcopenia are often present in liver cirrhosis. We aimed to investigate the effects of oral HMB supplementation on changes in body composition and liver status in patients with cirrhosis and malnutrition. In a randomized, controlled, double-blind trial, 43 individuals were randomized to receive twice a day and for 12 weeks an oral nutritional supplement (ONS) enriched with 1.5 g of calcium HMB per bottle or another supplement with similar composition devoid of HMB. Inclusion criteria were liver cirrhosis with at least one previous decompensation and clinical malnutrition. Liver function, plasma biochemistry analyses, and physical condition assessment were carried out at baseline, then after six and 12 weeks of supplementation. A total of 34 patients completed the clinical trial. An improvement in liver function and an increase in fat mass index were observed in both groups. None of the two ONS changed the fat-free mass. However, we observed an upward trend in handgrip strength and a downward trend in minimal hepatic encephalopathy in the HMB group. At the end of the trial and regardless of the supplement administered, fat mass content increased with no change in fat-free mass, while liver function scores and nutritional analytic markers also improved.",2022,"At the end of the trial and regardless of the supplement administered, fat mass content increased with no change in fat-free mass, while liver function scores and nutritional analytic markers also improved.","['Malnourished Cirrhotic Patients', 'patients with cirrhosis and malnutrition', '34 patients completed the clinical trial', 'Inclusion criteria were liver cirrhosis with at least one previous decompensation and clinical malnutrition', '43 individuals']","['β-Hydroxy-β-methylbutyrate (HMB) supplementation', 'oral nutritional supplement (ONS) enriched with 1.5 g of calcium HMB per bottle or another supplement with similar composition devoid of HMB', 'β-Hydroxy-β-Methylbutyrate (HMB)-Enriched vs. HMB-Free Oral Nutritional Supplementation', 'oral HMB supplementation']","['minimal hepatic encephalopathy', 'fat mass index', 'fat-free mass, while liver function scores and nutritional analytic markers', 'Liver function, plasma biochemistry analyses, and physical condition assessment', 'body composition and liver status', 'handgrip strength', 'liver function']","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C3888788', 'cui_str': 'Minimal hepatic encephalopathy'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",43.0,0.228753,"At the end of the trial and regardless of the supplement administered, fat mass content increased with no change in fat-free mass, while liver function scores and nutritional analytic markers also improved.","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Espina', 'Affiliation': 'Gastroenterology Department, Miguel Servet University Hospital, 50009 Zaragoza, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Sanz-Paris', 'Affiliation': 'Instituto de Investigación Sanitaria (IIS) Aragon, 50009 Zaragoza, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Gonzalez-Irazabal', 'Affiliation': 'Instituto de Investigación Sanitaria (IIS) Aragon, 50009 Zaragoza, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pérez-Matute', 'Affiliation': 'Infectious Diseases, Microbiota and Metabolism Unit, Center for Biomedical Research of La Rioja (CIBIR), 26006 Logroño, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Andrade', 'Affiliation': 'Metabolomics Platform, Biocruces Bizkaia Health Research Institute, 48903 Barakaldo, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Garcia-Rodriguez', 'Affiliation': 'Clinical Biochemistry Department, Miguel Servet University Hospital, 50009 Zaragoza, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Carpéné', 'Affiliation': 'Institute of Metabolic and Cardiovascular Diseases, INSERM, UMR1297, Team Dinamix, 31432 Toulouse, France.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Zakaroff', 'Affiliation': 'Institute of Metabolic and Cardiovascular Diseases, INSERM, UMR1297, Team Dinamix, 31432 Toulouse, France.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Bernal-Monterde', 'Affiliation': 'Gastroenterology Department, Miguel Servet University Hospital, 50009 Zaragoza, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fuentes-Olmo', 'Affiliation': 'Gastroenterology Department, Miguel Servet University Hospital, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Arbones-Mainar', 'Affiliation': 'Instituto de Investigación Sanitaria (IIS) Aragon, 50009 Zaragoza, Spain.'}]",Nutrients,['10.3390/nu14112344']
1432,35684140,Randomised Clinical Trial to Analyse the Efficacy of Eggshell Membrane to Improve Joint Functionality in Knee Osteoarthritis.,"Osteoarthritis is a source of chronic pain and disability. Dietary supplements have been shown to be a more secure option than NSAIDS. Particularly, the eggshell membrane has demonstrated efficacy in relieving joint pain and stiffness. A clinical trial was designed in which three groups were assigned to two different doses of this supplement and compared to a placebo control group. The primary outcome variable was knee pain, which was assessed using a visual analogue scale. Secondary outcome variables were knee functional ability, quadriceps muscle strength (assessed by isometric and isokinetic trials), and quality of sleep. All groups showed a significant decrease in pain perception, although maximum values were obtained in the high-dose group. Isokinetic and isometric trials showed a significant increase in strength in the high-dose group. Eggshell membrane showed the potential to reduce pain and stiffness symptomatology. Here, for the first time, two quantitative variables (mobility and strength of knee joint) were used to accurately evaluate changes in the quality of life of subjects affected by knee joint pain. The results of this study indicate a dose-dependent response, which should be taken into account for later use in therapeutics to establish the correct dosage.",2022,"All groups showed a significant decrease in pain perception, although maximum values were obtained in the high-dose group.",['Knee Osteoarthritis'],"['placebo control group', 'Eggshell Membrane']","['pain perception', 'knee functional ability, quadriceps muscle strength (assessed by isometric and isokinetic trials), and quality of sleep', 'quality of life', 'knee pain, which was assessed using a visual analogue scale', 'pain and stiffness symptomatology', 'strength']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013702', 'cui_str': 'Eggshell'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",,0.0552849,"All groups showed a significant decrease in pain perception, although maximum values were obtained in the high-dose group.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cánovas', 'Affiliation': 'Health Science Department, Campus de los Jerónimos, Universidad Católica San Antonio de Murcia UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'María Salud', 'Initials': 'MS', 'LastName': 'Abellán-Ruíz', 'Affiliation': 'Health Science Department, Campus de los Jerónimos, Universidad Católica San Antonio de Murcia UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'García-Muñoz', 'Affiliation': 'Health Science Department, Campus de los Jerónimos, Universidad Católica San Antonio de Murcia UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'Antonio Jesús', 'Initials': 'AJ', 'LastName': 'Luque-Rubia', 'Affiliation': 'Health Science Department, Campus de los Jerónimos, Universidad Católica San Antonio de Murcia UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Victoria-Montesinos', 'Affiliation': 'Health Science Department, Campus de los Jerónimos, Universidad Católica San Antonio de Murcia UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pérez-Piñero', 'Affiliation': 'Health Science Department, Campus de los Jerónimos, Universidad Católica San Antonio de Murcia UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'Maravilla', 'Initials': 'M', 'LastName': 'Sánchez-Macarro', 'Affiliation': 'Health Science Department, Campus de los Jerónimos, Universidad Católica San Antonio de Murcia UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'López-Román', 'Affiliation': 'Health Science Department, Campus de los Jerónimos, Universidad Católica San Antonio de Murcia UCAM, 30107 Murcia, Spain.'}]",Nutrients,['10.3390/nu14112340']
1433,35684131,Glycaemia Fluctuations Improvement in Old-Age Prediabetic Subjects Consuming a Quinoa-Based Diet: A Pilot Study.,"This study aimed to observe if quinoa could produce a benefit on postprandial glycemia that would result in less progression to type 2 diabetes (T2D). A cross-over design pilot clinical study with a nutritional intervention for 8 weeks was performed: 4 weeks on a regular diet (RD) and 4 weeks on a quinoa diet (QD). Nine subjects aged ≥65 years with prediabetes were monitored during the first 4 weeks of RD with daily dietary records and FreeStyle Libre ® . Subsequently, participants started the QD, where quinoa and 100% quinoa-based products replaced foods rich in complex carbohydrates that they had consumed in the first 4 weeks of RD. The glycemic measurements recorded by the sensors were considered as functions of time, and the effects of nutrients consumed at the intended time period were analyzed by means of a function-on-scalar regression (fosr) model. With QD participants, decreased body weight (-1.6 kg,  p  = 0.008), BMI (-0.6 kg/m 2 p  = 0.004) and waist circumference (-1.5 cm,  p  = 0.015) were observed. Nutrients intake changed during QD, namely, decreased carbohydrates ( p  = 0.004) and increased lipids ( p  = 0.004) and some amino acids ( p  &lt; 0.05). The fosr model showed a reduction in postprandial glycemia in QD despite intrapersonal differences thanks to the joint action of different nutrients and the suppression of others consumed on a regular diet. We conclude that in an old age and high T2D-risk population, a diet rich in quinoa reduces postprandial glycemia and could be a promising T2D-preventive strategy.",2022,The fosr model showed a reduction in postprandial glycemia in QD despite intrapersonal differences thanks to the joint action of different nutrients and the suppression of others consumed on a regular diet.,"['Old-Age Prediabetic Subjects Consuming a Quinoa-Based Diet', 'Nine subjects aged ≥65 years with prediabetes']","['RD with daily dietary records and FreeStyle Libre ® ', 'nutritional intervention', 'regular diet (RD) and 4 weeks on a quinoa diet (QD']","['amino acids', 'glycemic measurements', 'BMI', 'increased lipids', 'Glycaemia Fluctuations Improvement', 'body weight', 'waist circumference', 'postprandial glycemia']","[{'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C1504609', 'cui_str': 'Quinoa'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1504609', 'cui_str': 'Quinoa'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",9.0,0.0365898,The fosr model showed a reduction in postprandial glycemia in QD despite intrapersonal differences thanks to the joint action of different nutrients and the suppression of others consumed on a regular diet.,"[{'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Díaz-Rizzolo', 'Affiliation': 'Faculty of Health Science, Universitat Oberta de Catalunya, 08018 Barcelona, Spain.'}, {'ForeName': 'Nihan', 'Initials': 'N', 'LastName': 'Acar-Denizli', 'Affiliation': 'Department of Statistics and Operation Research, Universitat Politecnica de Catalunya, 08034 Barcelona, Spain.'}, {'ForeName': 'Belchin', 'Initials': 'B', 'LastName': 'Kostov', 'Affiliation': 'Primary Healthcare Transversal Research Group, IDIBAPS, 08036 Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Roura', 'Affiliation': 'Department of Health and Alimentary Habits, Alicia-elBulli Foundation, Sant Fruitós de Bages, 08272 Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Sisó-Almirall', 'Affiliation': 'Primary Healthcare Transversal Research Group, IDIBAPS, 08036 Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Delicado', 'Affiliation': 'Department of Statistics and Operation Research, Universitat Politecnica de Catalunya, 08034 Barcelona, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Gomis', 'Affiliation': 'Faculty of Health Science, Universitat Oberta de Catalunya, 08018 Barcelona, Spain.'}]",Nutrients,['10.3390/nu14112331']
1434,35667481,Finding humor in hormones: Oxytocin promotes laughing and smiling.,"Oxytocin (OT) is known for facilitating interpersonal interactions in favorable conditions. Humor, on the other hand, is an interpersonal phenomenon that reduces social distance. In this study, we investigated whether OT would increase laughing and smiling in a favorable environment. Therefore, participants were asked to view a brief video clip of a comedy television program in the presence of an ingroup member after administration of either OT or a placebo. Results demonstrated that participants in the OT condition exhibited more laughing and smiling behavior over the course of viewing the video compared to participants in the placebo condition. OT, however, neither affected self-reported affect nor perceived funniness of the clip. These findings indicate that OT, a hormone that can bolster attachment, also has the power to facilitate implicit social interactions by promoting visible and audible social signals, but does not affect the socially irrelevant inner cheerfulness.",2022,"OT, however, neither affected self-reported affect nor perceived funniness of the clip.",[],"['OT', 'Oxytocin (OT', 'OT or a placebo', 'video clip of a comedy television program']","['laughing and smiling behavior', 'laughing and smiling']",[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023133', 'cui_str': 'Laughing'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0582616,"OT, however, neither affected self-reported affect nor perceived funniness of the clip.","[{'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Pfundmair', 'Affiliation': 'Ludwig-Maximilians-University of Munich, Leopoldstr. 13, 80802 München, Germany; Federal University of Administrative Sciences, Habersaathstr. 51, 10115 Berlin, Germany. Electronic address: michaela.pfundmair@hsbund-nd.de.'}]",Biological psychology,['10.1016/j.biopsycho.2022.108377']
1435,35668567,Clinical efficacy and safety of norepinephrine combined with ulinastatin in the treatment of septic shock.,"To analyze the clinical efficacy and safety of norepinephrine combined with ulinastatin in the treatment of septic shock. 100 patients with septic shock treated in our institution from May 2019 to May 2021 were recruited and randomly assigned to receive either norepinephrine (control group) or norepinephrine plus ulinastatin (experimental group) according to the treatment scheme. The treatment efficacy, time for shock improvement, intensive care unit (ICU) stay, total hospital stay, in-hospital mortality, 30-day survival, and changes in inflammatory factors (plasma C-reactive protein (CRP), serum lactic acid (LAC), serum procalcitonin (PCT), and interleukin-10 (IL-10)) before and after treatment were analyzed, and the sequential organ failure scores of the two groups were compared. The experimental group exhibited superior performance with respect to efficacy, ICU stays, and total hospital stay, in-hospital mortality to the control group (all P<0.05). After treatment, the experimental group presented lower levels of CRP, LAC, PCT and IL-10 and higher SOFA scores than the control group (P<0.05). Norepinephrine plus ulinastatin achieved remarkable results in the treatment of septic shock, improving the treatment efficiency, shortening the time for shock improvement and hospitalization, reducing hospital mortality, driving down the expression of inflammatory factors and enhancing the survival of patients, with high safety.",2022,"After treatment, the experimental group presented lower levels of CRP, LAC, PCT and IL-10 and higher SOFA scores than the control group (P<0.05).","['septic shock', '100 patients with septic shock treated in our institution from May 2019 to May 2021']","['norepinephrine (control group) or norepinephrine plus ulinastatin', 'Norepinephrine plus ulinastatin', 'norepinephrine combined with ulinastatin']","['treatment efficiency, shortening the time for shock improvement and hospitalization, reducing hospital mortality, driving down the expression of inflammatory factors', 'treatment efficacy, time for shock improvement, intensive care unit (ICU) stay, total hospital stay, in-hospital mortality, 30-day survival, and changes in inflammatory factors (plasma C-reactive protein (CRP), serum lactic acid (LAC), serum procalcitonin (PCT), and interleukin-10 (IL-10', 'efficacy, ICU stays, and total hospital stay, in-hospital mortality', 'sequential organ failure scores', 'levels of CRP, LAC, PCT and IL-10 and higher SOFA scores']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0858129', 'cui_str': 'Serum lactic acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032452', 'cui_str': 'Polychlorotriphenyl Compounds'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0740974,"After treatment, the experimental group presented lower levels of CRP, LAC, PCT and IL-10 and higher SOFA scores than the control group (P<0.05).","[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Emergency and The Intensive Care Unit, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency and The Intensive Care Unit, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China.'}, {'ForeName': 'Guifang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency and The Intensive Care Unit, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': ""Department of Geriatrics, Chengdu Fifth People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Xie', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Emergency and The Intensive Care Unit, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China.'}]",Pakistan journal of pharmaceutical sciences,[]
1436,35670139,Mortality after multivitamin supplementation: Nearly 35-year follow-up of the randomized Linxian Dysplasia Nutrition Intervention Trial.,"BACKGROUND


The objective of this study was to update the association between multivitamin supplementation and total or cause-specific mortality in a population with a high prevalence of undernutrition in China.
METHODS


The Linxian Dysplasia Nutrition Intervention Trial was a randomized, double-blind, placebo-controlled trial in which 3318 persons aged 40-69 years with esophageal squamous dysplasia were assigned to receive daily multivitamin supplementation or a placebo for 6 years and were followed for 29 years. The primary outcome was esophageal/gastric cardia cancer mortality. The data were analyzed with Cox proportional hazards regression models. Subgroup analyses were performed by common characteristics such as age and gender.
RESULTS


The cumulative total mortality was 83.5%. Multivitamin supplementation did not affect total or cause-specific mortality in the participants as a whole (hazard ratio [HR], 0.96; 95% confidence interval [CI], 0.89-1.03). Subgroup analyses showed that no association between multivitamin supplementation and all-cause mortality was observed in men (HR, 0.90; 95% CI, 0.81-1.01), women (HR, 1.01; 95% CI, 0.91-1.12), younger participants (HR, 0.97; 95% CI, 0.87-1.08), or older participants (HR, 0.94; 95% CI, 0.85-1.04). Significant reductions in heart disease mortality (HR, 0.64; 95% CI, 0.47-0.87) and cerebrovascular disease mortality (HR, 0.74; 95% CI, 0.56-1.00) were seen in older men. In a subgroup of younger men and a subgroup of moderate or severe dysplasia, subjects receiving multivitamin supplementation had a lower risk of esophageal/cardia cancer mortality (HR for younger men, 0.76; 95% CI, 0.58-0.99; HR for moderate or severe dysplasia, 0.76; 95% CI, 0.58-1.00). No association between multivitamin supplementation and any cause-specific mortality was observed in a mild dysplasia population.
CONCLUSIONS


Multivitamin supplementation in a population with esophageal squamous dysplasia was not associated with the risk of total mortality in the 35-year follow-up of this randomized controlled trial. In light of this and previous trials, multivitamin supplements should be used thoughtfully to improve health status of populations with esophageal squamous dysplasia.
LAY SUMMARY


Multivitamin supplementation is common, yet its effect on mortality is unclear. The aim of this study was to update the long-term effects of multivitamin supplementation on total and cause-specific mortality during nearly 35 years of follow-up in the Linxian Dysplasia Nutrition Intervention Trial in China. Multivitamin supplementation in a population with esophageal squamous dysplasia was not associated with the risk of total mortality in the 35-year follow-up of this randomized controlled trial, and this indicates that multivitamin supplements should be used thoughtfully to improve health status.",2022,"Significant reductions in heart disease mortality (HR, 0.64; 95% CI, 0.47-0.87) and cerebrovascular disease mortality (HR, 0.74; 95% CI, 0.56-1.00) were seen in older men.","['population with esophageal squamous dysplasia', 'populations with esophageal squamous dysplasia', 'nearly 35\u2009years of follow-up in the Linxian Dysplasia Nutrition Intervention Trial in China', 'a population with a high prevalence of undernutrition in China', '3318 persons aged 40-69\u2009years with esophageal squamous dysplasia']","['multivitamin supplementation', 'Multivitamin supplementation', 'daily multivitamin supplementation or a placebo', 'multivitamin supplements', 'placebo']","['heart disease mortality', 'total and cause-specific mortality', 'esophageal/gastric cardia cancer mortality', 'cerebrovascular disease mortality', 'Mortality', 'total mortality', 'total or cause-specific mortality', 'cumulative total mortality', 'cause-specific mortality', 'risk of esophageal/cardia cancer mortality', 'cause mortality']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007144', 'cui_str': 'Cardia structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",3318.0,0.686593,"Significant reductions in heart disease mortality (HR, 0.64; 95% CI, 0.47-0.87) and cerebrovascular disease mortality (HR, 0.74; 95% CI, 0.56-1.00) were seen in older men.","[{'ForeName': 'Jin-Hu', 'Initials': 'JH', 'LastName': 'Fan', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jian-Bing', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': ""Department of Epidemiology and Biostatistics, Children's Hospital, National Clinical Research Center for Child Health, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Sanford M', 'Initials': 'SM', 'LastName': 'Dawsey', 'Affiliation': 'Metabolic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Taylor', 'Affiliation': 'Metabolic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA.'}, {'ForeName': 'You-Lin', 'Initials': 'YL', 'LastName': 'Qiao', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Abnet', 'Affiliation': 'Metabolic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA.'}]",Cancer,['10.1002/cncr.34344']
1437,35670873,"A Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 3 Weeks of Orally Administered Gefapixant in Healthy Younger and Older Adults.","PURPOSE


Patients with chronic cough are typically female and have a mean age of ~ 60 years. However, initial pharmacokinetic (PK) characterization of the P2X3-receptor antagonist gefapixant, developed to treat refractory or unexplained chronic cough, was performed in healthy participants who were predominantly younger adult males. The objective of this Phase 1 study was to assess the safety, tolerability, and PK of gefapixant in younger (18-55 years) and older (65-80 years) males and females.
METHODS


A randomized, double-blind, placebo-controlled study was conducted. Healthy adult participants were stratified into 4 cohorts by age and sex (younger males/females and older males/females) and randomized 4:1 (younger adults) or 3:1 (older adults) to receive gefapixant 300 mg twice daily (BID) for 1 week, followed by gefapixant 600 mg BID for 2 weeks or placebo. Safety, tolerability, and PK were assessed.
RESULTS


Of 36 randomized and treated participants, 28 (100%) receiving gefapixant and 6 (75%) receiving placebo reported ≥ 1 adverse event (AE). The most common treatment-related AEs in the gefapixant group were taste related. Predefined renal/urologic AEs were reported by 7 (25%) participants receiving gefapixant (all mild to moderate in severity). Gefapixant exposure was generally lower in younger males compared with younger females and older adults; however, differences may have been due to estimated glomerular filtration rate.
CONCLUSION


The safety profile of gefapixant 300-600 mg BID was generally consistent with previous studies. Additional characterization of gefapixant PK as a function of age and sex using population PK modeling is warranted.",2022,The most common treatment-related AEs in the gefapixant group were taste related.,"['Healthy Younger and Older Adults', 'healthy participants who were predominantly younger adult males', 'younger (18-55\xa0years) and older (65-80\xa0years) males and females', 'Patients with chronic cough are typically female and have a mean age of\u2009~\u200960\xa0years', 'Healthy adult participants were stratified into 4 cohorts by age and sex (younger males/females and older males/females) and randomized 4:1 (younger adults) or 3:1 (older adults']","['Gefapixant', 'gefapixant 300\xa0mg twice daily (BID) for 1\xa0week, followed by gefapixant 600\xa0mg BID for 2\xa0weeks or placebo', 'gefapixant PK', 'placebo reported\u2009≥\u20091 adverse event (AE', 'placebo', 'Placebo']","['Predefined renal/urologic AEs', 'Safety, tolerability, and PK', 'Safety, Tolerability, and Pharmacokinetics', 'safety, tolerability, and PK of gefapixant']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.351586,The most common treatment-related AEs in the gefapixant group were taste related.,"[{'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Nussbaum', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA. jesse.nussbaum@merck.com.'}, {'ForeName': 'Azher', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ford', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Butera', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kitt', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}]",Lung,['10.1007/s00408-022-00543-0']
1438,35672726,"Less meat in the shopping basket. The effect on meat purchases of higher prices, an information nudge and the combination: a randomised controlled trial.","BACKGROUND


Reduced meat consumption benefits human and planetary health. Modelling studies have demonstrated the significant health and environmental gains that could be achieved through fiscal measures targeting meat. Adding other interventions may enhance the effect of a fiscal measure. The current study aimed to examine the effect of higher meat prices, an information nudge and a combination of both measures on meat purchases in a three-dimensional virtual supermarket.
METHODS


A parallel designed randomised controlled trial with four conditions was performed. Participants (≥ 18 years) were randomly assigned to the control condition or one of the experimental conditions: a 30% price increase for meat ('Price condition'), an information nudge about the environmental impact of meat production and consumers' role in that regard ('Information nudge condition') or a combination of both ('Combination condition'). Participants were asked to shop for their household for one week. The primary outcome was the difference in the total amount of meat purchased in grams per household per week.
RESULTS


Between 22 June 2020 and 28 August 2020, participants were recruited and randomly assigned to the control and experimental conditions. The final sample included 533 participants. In the 'Combination condition', - 386 g (95% CI: - 579, - 193) meat was purchased compared with the 'Control condition'. Compared to the 'Control condition' less meat was purchased in the 'Price condition' (- 144 g (95%CI: - 331, 43)), although not statistically significant, whereas a similar amount of meat was purchased in the 'Information nudge condition' (1 g (95%CI: - 188, 189)).
CONCLUSION


Achieving the most pronounced effects on reduced meat purchases will require a policy mixture of pricing and informational nudging. Less meat is purchased in a virtual supermarket after raising the meat price by 30% combined with an information nudge. The results could be used to design evidence-based policy measures to reduce meat purchases.
TRIAL REGISTRATION


The trial was registered in the Netherlands Trial Register identifier NL8628 . Registered on 18/05/2020. ICTRP Search Portal (who.int) NTR (trialregister.nl).",2022,"Compared to the 'Control condition' less meat was purchased in the 'Price condition' (- 144 g (95%CI: - 331, 43)), although not statistically significant, whereas a similar amount of meat was purchased in the 'Information nudge condition' (1 g (95%CI: - 188, 189)).
","['Participants (≥ 18\u2009years', 'Between 22 June 2020 and 28 August 2020, participants', '533 participants']","[""control condition or one of the experimental conditions: a 30% price increase for meat ('Price condition'), an information nudge about the environmental impact of meat production and consumers' role in that regard ('Information nudge condition') or a combination of both ('Combination condition"", 'ICTRP Search Portal (who.int) NTR (trialregister.nl']",['total amount of meat purchased in grams per household per week'],"[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0282165', 'cui_str': 'Environmental Impact'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205054', 'cui_str': 'Portal'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",533.0,0.119173,"Compared to the 'Control condition' less meat was purchased in the 'Price condition' (- 144 g (95%CI: - 331, 43)), although not statistically significant, whereas a similar amount of meat was purchased in the 'Information nudge condition' (1 g (95%CI: - 188, 189)).
","[{'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Vellinga', 'Affiliation': 'National Institute for Public Health and the Environment, Antonie van Leeuwenhoeklaan 9, Bilthoven, 3721, MA, The Netherlands. reina.vellinga@rivm.nl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Eykelenboom', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Olthof', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'I H M', 'Initials': 'IHM', 'LastName': 'Steenhuis', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Jonge', 'Affiliation': 'National Institute for Public Health and the Environment, Antonie van Leeuwenhoeklaan 9, Bilthoven, 3721, MA, The Netherlands.'}, {'ForeName': 'E H M', 'Initials': 'EHM', 'LastName': 'Temme', 'Affiliation': 'National Institute for Public Health and the Environment, Antonie van Leeuwenhoeklaan 9, Bilthoven, 3721, MA, The Netherlands.'}]",BMC public health,['10.1186/s12889-022-13535-9']
1439,35672703,"Intermittent screening and treatment for malaria complementary to routine immunisation in the first year of life in Papua, Indonesia: a cluster randomised superiority trial.","BACKGROUND


In Papua (Indonesia), infants with P. falciparum and/or P. vivax malaria are at risk of severe anaemia and death. We hypothesized that in an area of high malaria transmission, intermittent screening and treatment of infants with malaria (ISTi) will reduce morbidity compared to passive case detection (PCDi).
METHODS


We conducted a cluster randomised, open label, superiority trial. A total of 21 clusters of village health posts (VHP) were randomised 1:1 to either IST for infants coinciding with 4 routine immunisation visits or PCDi. Healthy term infants born to consenting mothers enrolled into a maternal malaria cluster randomised trial were included in the study and followed for 12 months. Point of care malaria rapid diagnostic tests were used to detect peripheral parasitaemia at 2, 3, 4 and 9 months old in all infants in ISTi clusters and when symptomatic in PCDi clusters. Infants with detected peripheral parasitaemia were treated with dihydroartemisinin-piperaquine. The co-primary outcomes were the incidence rate of clinical malaria in the first year of life and the prevalence of parasitaemia at age 12 months. The incidence rate ratio and prevalence ratio between ISTi and PCDi were estimated using mixed-effects Poisson and log-binomial regression modelling (accounting for clustering at VHP level).
RESULTS


Between May 2014 and February 2017, 757 infants were enrolled into the study, 313 into 10 ISTi clusters, and 444 into 11 PCDi clusters. Overall, 132 episodes of parasitaemia were detected, of whom 17 (12.9%) were in symptomatic infants. Over 12 months, the incidence rate (IR) of clinical malaria was 24 [95% CI, 10-50] per 1000 children-years at risk in the ISTi arm and 19 [95% CI, 8,38] per 1000 children-years in the PCDi arm (adjusted incidence rate ratio [aIRR] 1.77 [95% CI, 0.62-5.01]; p = 0.280). The prevalence of parasitaemia at 12 months was 13% (33/254) in the IST clusters and 15% (57/379) in the PCD clusters (adjusted prevalence ratio (aPR) = 0.92 (95% CI, 0.70-1.21), p = 0.55). There was no difference in the risk of anaemia between treatment arms.
CONCLUSIONS


In high malaria transmission area outside of Africa, our study suggests that compared to PCDi, ISTi offers no significant benefit in reducing the risk of clinical malaria in infants born to women receiving effective protection from malaria during pregnancy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02001428 , registered on 20 Nov 2013.",2022,"Overall, 132 episodes of parasitaemia were detected, of whom 17 (12.9%) were in symptomatic infants.","['Papua, Indonesia', 'infants born to women receiving effective protection from malaria during pregnancy', 'Healthy term infants born to consenting mothers enrolled into a maternal malaria cluster randomised trial were included in the study and followed for 12\u2009months', 'Infants with detected peripheral parasitaemia', 'Between May 2014 and February 2017, 757 infants were enrolled into the study, 313 into 10 ISTi clusters, and 444 into 11 PCDi clusters', 'A total of 21 clusters of village health posts (VHP', 'infants with malaria (ISTi']","['IST', 'dihydroartemisinin-piperaquine']","['132 episodes of parasitaemia', 'incidence rate (IR) of clinical malaria', 'prevalence of parasitaemia', 'incidence rate of clinical malaria in the first year of life and the prevalence of parasitaemia', 'risk of anaemia', 'incidence rate ratio and prevalence ratio between ISTi and PCDi', 'peripheral parasitaemia']","[{'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]",757.0,0.329944,"Overall, 132 episodes of parasitaemia were detected, of whom 17 (12.9%) were in symptomatic infants.","[{'ForeName': 'Jeanne Rini', 'Initials': 'JR', 'LastName': 'Poespoprodjo', 'Affiliation': 'Centre for Child Health and Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Jl. Kesehatan no.1, Sekip, Yogyakarta, 55284, Indonesia. didot2266@yahoo.com.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Hafiidhaturrahmah', 'Affiliation': 'Timika Malaria Research Facility, Papuan Health and Community Development Foundation, Jl. SP2-SP5, RSMM Area, Timika, Papua, 99910, Indonesia.'}, {'ForeName': 'Novita', 'Initials': 'N', 'LastName': 'Sariyanti', 'Affiliation': 'Timika Malaria Research Facility, Papuan Health and Community Development Foundation, Jl. SP2-SP5, RSMM Area, Timika, Papua, 99910, Indonesia.'}, {'ForeName': 'Ratni', 'Initials': 'R', 'LastName': 'Indrawanti', 'Affiliation': 'Centre for Child Health and Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Jl. Kesehatan no.1, Sekip, Yogyakarta, 55284, Indonesia.'}, {'ForeName': 'Alistair R D', 'Initials': 'ARD', 'LastName': 'McLean', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, VIC, 3010, Melbourne, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Simpson', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, VIC, 3010, Melbourne, Australia.'}, {'ForeName': 'Enny', 'Initials': 'E', 'LastName': 'Kenangalem', 'Affiliation': 'Timika Malaria Research Facility, Papuan Health and Community Development Foundation, Jl. SP2-SP5, RSMM Area, Timika, Papua, 99910, Indonesia.'}, {'ForeName': 'Faustina Helena', 'Initials': 'FH', 'LastName': 'Burdam', 'Affiliation': 'Timika Malaria Research Facility, Papuan Health and Community Development Foundation, Jl. SP2-SP5, RSMM Area, Timika, Papua, 99910, Indonesia.'}, {'ForeName': 'Rintis', 'Initials': 'R', 'LastName': 'Noviyanti', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jl. Diponegoro No.69, Jakarta, 10430, Indonesia.'}, {'ForeName': 'Leily', 'Initials': 'L', 'LastName': 'Trianty', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jl. Diponegoro No.69, Jakarta, 10430, Indonesia.'}, {'ForeName': 'Chairunisa', 'Initials': 'C', 'LastName': 'Fadhilah', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jl. Diponegoro No.69, Jakarta, 10430, Indonesia.'}, {'ForeName': 'Yati', 'Initials': 'Y', 'LastName': 'Soenarto', 'Affiliation': 'Centre for Child Health and Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Jl. Kesehatan no.1, Sekip, Yogyakarta, 55284, Indonesia.'}, {'ForeName': 'Ric N', 'Initials': 'RN', 'LastName': 'Price', 'Affiliation': 'Global Health Division, Menzies School of Health Research and Charles Darwin University, PO Box 41096, Casuarina, Darwin, NT, 0811, Australia.'}]",BMC medicine,['10.1186/s12916-022-02394-1']
1440,35672690,Outcomes from a mechanistic biomarker multi-arm and randomised study of liposomal MTP-PE (Mifamurtide) in metastatic and/or recurrent osteosarcoma (EuroSarc-Memos trial).,"The phase III clinical study of adjuvant liposomal muramyl tripeptide (MTP-PE) in resected high-grade osteosarcoma (OS) documented positive results that have been translated into regulatory approval, supporting initial promise for innate immune therapies in OS. There remains, however, no new approved treatment such as MTP-PE for either metastatic or recurrent OS. Whilst the addition of different agents, including liposomal MTP-PE, to surgery for metastatic or recurrent high-grade osteosarcoma has tried to improve response rates, a mechanistic hiatus exists in terms of a detailed understanding the therapeutic strategies required in advanced disease. Here we report a Bayesian designed multi-arm, multi-centre, open-label phase II study with randomisation in patients with metastatic and/or recurrent OS, designed to investigate how patients with OS might respond to liposomal MTP-PE, either given alone or in combination with ifosfamide. Despite the trial closing because of poor recruitment within the allocated funding period, with no objective responses in eight patients, we report the design and feasibility outcomes for patients registered into the trial. We demonstrate the feasibility of the Bayesian design, European collaboration, tissue collection with genomic analysis and serum cytokine characterisation. Further mechanistic investigation of liposomal MTP-PE alone and in combination with other agents remains warranted in metastatic OS.",2022,"The phase III clinical study of adjuvant liposomal muramyl tripeptide (MTP-PE) in resected high-grade osteosarcoma (OS) documented positive results that have been translated into regulatory approval, supporting initial promise for innate immune therapies in OS.","['patients with metastatic and/or recurrent OS', 'resected high-grade osteosarcoma (OS', 'metastatic and/or recurrent osteosarcoma (EuroSarc-Memos trial']","['liposomal MTP-PE (Mifamurtide', 'adjuvant liposomal muramyl tripeptide (MTP-PE', 'liposomal MTP-PE', 'liposomal MTP-PE, either given alone or in combination with ifosfamide', 'liposomal MTP-PE alone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0278779', 'cui_str': 'Osteosarcoma recurrent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0129341', 'cui_str': 'mifamurtide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}]",[],,0.0831283,"The phase III clinical study of adjuvant liposomal muramyl tripeptide (MTP-PE) in resected high-grade osteosarcoma (OS) documented positive results that have been translated into regulatory approval, supporting initial promise for innate immune therapies in OS.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Barnes', 'Affiliation': 'Oxford Molecular Pathology Institute, Sir William Dunn School of Pathology, University of Oxford, South Parks Road, and Oxford University Hospital NHS Trust, Oxford, OX1 3RE, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dutton', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences and Centre for Statistics in Medicine (CSM), University of Oxford, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Bruland', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo and Department of Oncology-Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, P.O. Box 9600, Postzone K1-P, 2300RC, Leiden, The Netherlands.'}, {'ForeName': 'Ade', 'Initials': 'A', 'LastName': 'Faleti', 'Affiliation': 'Department of Oncology Early Phase trials unit and Oncology Clinical Trials Office (OCTO), University of Oxford, Old Road Campus Research Building, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bühnemann', 'Affiliation': 'Oxford Molecular Pathology Institute, Sir William Dunn School of Pathology, University of Oxford, South Parks Road, and Oxford University Hospital NHS Trust, Oxford, OX1 3RE, UK.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'van Maldegem', 'Affiliation': 'Oxford Molecular Pathology Institute, Sir William Dunn School of Pathology, University of Oxford, South Parks Road, and Oxford University Hospital NHS Trust, Oxford, OX1 3RE, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'Department of Oncology Early Phase trials unit and Oncology Clinical Trials Office (OCTO), University of Oxford, Old Road Campus Research Building, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Poulton', 'Affiliation': 'Department of Oncology Early Phase trials unit and Oncology Clinical Trials Office (OCTO), University of Oxford, Old Road Campus Research Building, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences and Centre for Statistics in Medicine (CSM), University of Oxford, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Tiemeier', 'Affiliation': 'Oxford Molecular Pathology Institute, Sir William Dunn School of Pathology, University of Oxford, South Parks Road, and Oxford University Hospital NHS Trust, Oxford, OX1 3RE, UK.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'van Beelen', 'Affiliation': 'Leiden University Medical Center, P.O. Box 9600, Postzone K1-P, 2300RC, Leiden, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Herbschleb', 'Affiliation': 'Department of Oncology Early Phase trials unit and Oncology Clinical Trials Office (OCTO), University of Oxford, Old Road Campus Research Building, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Haddon', 'Affiliation': 'Department of Oncology Early Phase trials unit and Oncology Clinical Trials Office (OCTO), University of Oxford, Old Road Campus Research Building, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Billingham', 'Affiliation': 'Cancer Research Clinical Trials Unit (Cancer Sciences), Institute of Cancer and Genomic Sciences, Robert Aitken Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bradley', 'Affiliation': 'Department of Radiology, Churchill Hospital, Oxford University Hospitals Foundation Trust, Oxford, OX3 7LJ, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Istituti Ortopedici Rizzoli, Via C. Pupilli 1, 40136, Bologna, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Palmerini', 'Affiliation': 'Istituti Ortopedici Rizzoli, Via C. Pupilli 1, 40136, Bologna, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Picci', 'Affiliation': 'Istituti Ortopedici Rizzoli, Via C. Pupilli 1, 40136, Bologna, Italy.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Dirksen', 'Affiliation': 'Pediatrics III, West German Cancer Centre Network Essen-Muenster, University Hospital Essen, Hufelanstr 55, Essen, 45147, Germany.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Strauss', 'Affiliation': 'Department of Oncology, UCLH NHS Foundation Trust, 250 Euston Road, London, NW1 2PG, UK.'}, {'ForeName': 'Pancras C W', 'Initials': 'PCW', 'LastName': 'Hogendoorn', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences and Centre for Statistics in Medicine (CSM), University of Oxford, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Emmeline', 'Initials': 'E', 'LastName': 'Buddingh', 'Affiliation': 'Leiden University Medical Center, P.O. Box 9600, Postzone K1-P, 2300RC, Leiden, The Netherlands.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Universitè Lyon 1 Claude Bernard, Lyon, France.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Cleton-Jansen', 'Affiliation': 'Leiden University Medical Center, P.O. Box 9600, Postzone K1-P, 2300RC, Leiden, The Netherlands.'}, {'ForeName': 'Andrew Bassim', 'Initials': 'AB', 'LastName': 'Hassan', 'Affiliation': 'Oxford Molecular Pathology Institute, Sir William Dunn School of Pathology, University of Oxford, South Parks Road, and Oxford University Hospital NHS Trust, Oxford, OX1 3RE, UK. bass.hassan@path.ox.ac.uk.'}]",BMC cancer,['10.1186/s12885-022-09697-9']
1441,35674566,Response to: RSBMT-2018-0270.R2 - Pain and quality of life in human T cell lymphotropic virus type 1 associated myelopathy or tropical spastic paraparesis after home-based exercise protocol: Randomized clinical trial.,,2022,,['human T cell lymphotropic virus type 1 associated myelopathy or tropical spastic paraparesis after home-based exercise protocol'],[],[],"[{'cui': 'C0020094', 'cui_str': 'Human T-lymphotropic virus 1'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],[],,0.18256,,"[{'ForeName': 'Maíra Carvalho', 'Initials': 'MC', 'LastName': 'Macêdo', 'Affiliation': 'Escola Bahiana de Medicina e Saúde Pública, Programa de Pós-graduação em Medicina e Saúde Humana, Salvador, BA, Brasil.'}, {'ForeName': 'Renata de Sousa', 'Initials': 'RS', 'LastName': 'Mota', 'Affiliation': 'Universidade Federal do Recôncavo da Bahia, Curso de Engenharia em Tecnologia Assistiva e Acessibilidade, Cruz das Almas, BA, Brasil.'}, {'ForeName': 'Naiane Araújo', 'Initials': 'NA', 'LastName': 'Patrício', 'Affiliation': 'Universidade Federal da Bahia, Programa de Pós-graduação em Medicina e Saúde, Salvador, BA, Brasil.'}, {'ForeName': 'Abrahão Fontes', 'Initials': 'AF', 'LastName': 'Baptista', 'Affiliation': 'Universidade Federal da Bahia, Programa de Pós-graduação em Medicina e Saúde, Salvador, BA, Brasil.'}, {'ForeName': 'Antônio de Souza', 'Initials': 'AS', 'LastName': 'Andrade Filho', 'Affiliation': 'Escola Bahiana de Medicina e Saúde Pública, Programa de Pós-graduação em Medicina e Saúde Humana, Salvador, BA, Brasil.'}, {'ForeName': 'Katia Nunes', 'Initials': 'KN', 'LastName': 'Sá', 'Affiliation': 'Escola Bahiana de Medicina e Saúde Pública, Programa de Pós-graduação em Medicina e Saúde Humana, Salvador, BA, Brasil.'}]",Revista da Sociedade Brasileira de Medicina Tropical,['10.1590/0037-8682-0723-2021']
1442,35674591,Bolus versus continuous insulin infusion in immediate postoperative blood glucose control in liver transplantation: pragmatic clinical trial.,"OBJECTIVE


To analyze the effectiveness and safety of two insulin therapy techniques (continuous and intermittent infusion) in the blood glucose control of people who have undergone liver transplantation, in the immediate postoperative period.
METHODS


The study was a prospective, open, pragmatic clinical trial with 42 participants, divided into two groups of 21 patients each, in the immediate postoperative period following liver transplantation. Participants in the Experimental Group and Control Group received continuous infusion and bolus insulin, respectively, starting at capillary blood glucose ≥150mg/dL.
RESULTS


There were no statistically significant differences in the blood glucose reduction time to reach the target range between the Experimental Group and Control Group in the transplanted patients (p=0.919). No statistically significant differences regarding the presence of low blood glucose (p=0.500) and in the initial blood glucose value (p=0.345) were found. The study identified the final blood glucose value in postoperative intensive care unit lower and statistically significant in the continuous infusion pump group in relation to the Bolus Group (p<0.001). Additionally, the variation of blood glucose reduction was higher and statistically significant in the continuous method group (p<0.05).
CONCLUSION


The continuous infusion method was more effective in the blood glucose control of patients in the postoperative period following liver transplantation.
BRAZILIAN REGISTRY OF CLINICAL TRIALS


RBR-9Y5tbp.",2022,There were no statistically significant differences in the blood glucose reduction time to reach the target range between the Experimental Group and Control Group in the transplanted patients (p=0.919).,"['people who have undergone liver transplantation, in the immediate postoperative period', '42 participants, divided into two groups of 21 patients each, in the immediate postoperative period following liver transplantation', 'liver transplantation']","['continuous insulin infusion', 'insulin therapy techniques (continuous and intermittent infusion', 'continuous infusion and bolus insulin, respectively, starting at capillary blood glucose']","['blood glucose reduction', 'low blood glucose', 'blood glucose control', 'initial blood glucose value', 'blood glucose reduction time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",42.0,0.0142786,There were no statistically significant differences in the blood glucose reduction time to reach the target range between the Experimental Group and Control Group in the transplanted patients (p=0.919).,"[{'ForeName': 'Luciana Vládia Carvalhêdo', 'Initials': 'LVC', 'LastName': 'Fragoso', 'Affiliation': 'Hospital Universitário Walter Cantídio, Universidade Federal do Ceará, Fortaleza, CE, Brazil.'}, {'ForeName': 'Márcio Flávio Moura de', 'Initials': 'MFM', 'LastName': 'Araújo', 'Affiliation': 'Fundação Oswaldo Cruz, Eusébio, CE, Brazil.'}, {'ForeName': 'Lidianne Fernandes da Silva', 'Initials': 'LFDS', 'LastName': 'Lobo', 'Affiliation': 'Hospital Universitário Walter Cantídio, Universidade Federal do Ceará, Fortaleza, CE, Brazil.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schreen', 'Affiliation': 'Hospital Universitário Walter Cantídio, Universidade Federal do Ceará, Fortaleza, CE, Brazil.'}, {'ForeName': 'Maria Lúcia', 'Initials': 'ML', 'LastName': 'Zanetti', 'Affiliation': 'Escola de Enfermagem de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Marta Maria Coelho', 'Initials': 'MMC', 'LastName': 'Damasceno', 'Affiliation': 'Universidade Federal do Ceará, Fortaleza, CE, Brazil.'}]","Einstein (Sao Paulo, Brazil)",['10.31744/einstein_journal/2022AO6959']
1443,35675604,Relugolix Combination Therapy for Uterine Leiomyoma-Associated Pain in the LIBERTY Randomized Trials.,"OBJECTIVE


To assess the effect of once-daily relugolix combination therapy (relugolix-CT: relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) compared with placebo on moderate-to-severe pain in women with uterine leiomyomas and heavy menstrual bleeding.
METHODS


Two replicate, multinational, double-blind, 24-week, randomized, phase 3 studies (LIBERTY 1 and 2) were conducted in premenopausal women with uterine leiomyoma-associated heavy menstrual bleeding (80 mL or greater per cycle for two cycles or 160 mL or greater during one cycle). A predefined secondary objective was to determine the effect of relugolix-CT on moderate-to-severe uterine leiomyoma-associated pain in the pain subpopulation (women with maximum pain scores of 4 or higher on the 0-10 numerical rating scale at baseline, with pain score reporting compliance of 80% (ie, 28 days or more over the last 35 days of treatment). This key secondary endpoint was defined as the proportion of women achieving minimal-to-no uterine leiomyoma-associated pain (maximum numerical rating scale score 1 or lower) at week 24; menstrual and nonmenstrual pain were evaluated in prespecified secondary analyses. Treatment comparisons were performed in the pooled LIBERTY 1 and 2 pain subpopulation using the Cochran-Mantel-Haenszel test stratified by baseline menstrual blood loss volume.
RESULTS


Across both trials, 509 women were randomized to relugolix-CT or placebo (April 2017-December 2018). Of these, 277 (54.4%) met pain subpopulation requirements. With relugolix-CT, 45.2% (95% CI 36.4-54.3) of women achieved minimal-to-no pain compared with 13.9% (95% CI 8.8-20.5) with placebo (nominal P<.001). The proportions of women with minimal-to-no pain during menstrual days and during nonmenstrual days were significantly higher with relugolix-CT (65.0% [95% CI 55.6-73.5] and 44.6% [95% CI 32.3-57.5], respectively) compared with placebo (19.3% [95% CI 13.2-26.7], nominal P<.001, and 21.6% [95% CI 12.9-32.7], nominal P=.004, respectively).
CONCLUSION


Over 24 weeks, relugolix-CT significantly reduced moderate-to-severe uterine leiomyoma-associated pain with a more pronounced effect on menstrual pain. These data support that relugolix-CT had clinically meaningful effects on women's experience of uterine leiomyoma-associated pain.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: LIBERTY 1, NCT03049735; LIBERTY 2, NCT03103087.
FUNDING SOURCE


Myovant Sciences GmbH.",2022,"With relugolix-CT, 45.2% (95% CI 36.4-54.3) of women achieved minimal-to-no pain compared with 13.9% (95% CI 8.8-20.5) with placebo (nominal P<.001).","['premenopausal women with uterine leiomyoma-associated heavy menstrual bleeding (80 mL or greater per cycle for two cycles or 160 mL or greater during one cycle', '509 women', 'women with uterine leiomyomas and heavy menstrual bleeding', 'moderate-to-severe uterine leiomyoma-associated pain in the pain subpopulation (women with maximum pain scores of 4 or higher on the 0-10 numerical rating scale at baseline, with pain score reporting compliance of 80% (ie, 28 days or more over the last 35 days of treatment']","['Relugolix Combination Therapy', 'relugolix-CT', 'relugolix combination therapy (relugolix-CT: relugolix 40 mg, estradiol 1 mg, and norethindrone acetate', 'placebo', 'relugolix-CT or placebo']","['menstrual pain', 'proportions of women with minimal-to-no pain', 'proportion of women achieving minimal-to-no uterine leiomyoma-associated pain (maximum numerical rating scale score 1 or lower) at week 24; menstrual and nonmenstrual pain', 'moderate-to-severe uterine leiomyoma-associated pain', 'relugolix-CT', 'moderate-to-severe pain', 'minimal-to-no pain']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0985841', 'cui_str': 'Estradiol 1 MG'}, {'cui': 'C0068980', 'cui_str': 'Norethindrone acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]",509.0,0.496395,"With relugolix-CT, 45.2% (95% CI 36.4-54.3) of women achieved minimal-to-no pain compared with 13.9% (95% CI 8.8-20.5) with placebo (nominal P<.001).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stewart', 'Affiliation': ""Mayo Clinic, Rochester, Minnesota; the Carolina Woman's Research and Wellness Center, Durham, North Carolina; the Department of Clinical and Experimental Medicine, Unit of Obstetrics and Gynecology, Magna Graecia University of Catanzaro, Catanzaro, Italy; Myovant Sciences, Inc., Brisbane, California; Myovant Sciences GmbH, Basel, Switzerland; and the Department of Obstetrics and Gynecology, University of Chicago, Chicago, Illinois.""}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Lukes', 'Affiliation': ''}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Venturella', 'Affiliation': ''}, {'ForeName': 'Juan-Camilo', 'Initials': 'JC', 'LastName': 'Arjona Ferreira', 'Affiliation': ''}, {'ForeName': 'Yulan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Hunsche', 'Affiliation': ''}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Wagman', 'Affiliation': ''}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Al-Hendy', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004787']
1444,35678033,"Different effects might be introduced by blinding in acupuncture: Comments on Wang et al's ""Placebo response varies between different types of sham acupuncture: A randomized double-blind trial in neck pain patients"".",,2022,,['neck pain patients'],['acupuncture'],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.623391,,"[{'ForeName': 'Tae-Hun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Myeong Soo', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Birch', 'Affiliation': 'School of Health Sciences, Kristiania University College, Oslo, Norway.'}, {'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Alraek', 'Affiliation': 'School of Health Sciences, Kristiania University College, Oslo, Norway.'}]","European journal of pain (London, England)",['10.1002/ejp.1993']
1445,35678369,Effects of prenatal group program in rural Tanzania: A quasi-experimental study.,"AIM


This study conducted in rural Tanzania examined the effects of a midwife-led prenatal group program on: (1) improvement of knowledge of the physiological symptoms of pregnancy; (2) promotion of pregnancy-related empowerment; (3) enhancement of intention to self-care behaviors for safer childbirth; and (4) gaining satisfaction with antenatal care visits.
METHODS


This work was a quasi-experimental study with a control group using a pre-post study design conducted in two district hospitals in Tanzania. Data were collected from 108 analyzed pregnant women from the prenatal group program (n = 54) and control program (n = 54) using questionnaires before (baseline) and after (endline) the program. The program consisted of lecture, sharing, and review sessions. The control program consisted of the same lectures. The contents of both programs included physiological symptoms of pregnancy and self-care behaviors. The primary outcome was knowledge of common symptoms of pregnancy. The secondary outcomes were Pregnancy-Related Empowerment Scale score, intention to self-care behaviors, and satisfaction.
RESULTS


The primary outcome of knowledge of common symptoms of pregnancy was significantly increased in the intervention group compared with the control group (t = 2.677, p = .009). The secondary outcome of one of the Pregnancy-Related Empowerment Scale statements about midwife's respectful attitude toward women's decision was significantly increased in the intervention group compared with the control group (U = 2.076, p = .038).
CONCLUSIONS


The interventional prenatal group program during pregnancy was effective in increasing knowledge of common symptoms of pregnancy and in identifying favorable midwife connectedness.",2022,The interventional prenatal group program during pregnancy was effective in increasing knowledge of common symptoms of pregnancy and in identifying favorable midwife connectedness.,"['two district hospitals in Tanzania', 'rural Tanzania', '108 analyzed pregnant women from the prenatal group program (n\xa0=\xa054) and control program (n\xa0=\xa054) using questionnaires before (baseline) and after (endline) the program']",['midwife-led prenatal group program'],"['Pregnancy-Related Empowerment Scale score, intention to self-care behaviors, and satisfaction', ""Pregnancy-Related Empowerment Scale statements about midwife's respectful attitude toward women's decision"", 'physiological symptoms of pregnancy and self-care behaviors', 'knowledge of common symptoms of pregnancy']","[{'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205214', 'cui_str': 'Common'}]",108.0,0.0142133,The interventional prenatal group program during pregnancy was effective in increasing knowledge of common symptoms of pregnancy and in identifying favorable midwife connectedness.,"[{'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Oka', 'Affiliation': ""St. Luke's International University, Tokyo, Japan.""}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Madeni', 'Affiliation': 'Korogwe District Hospital, Tanga, Tanzania.'}, {'ForeName': 'Shigeko', 'Initials': 'S', 'LastName': 'Horiuchi', 'Affiliation': ""St. Luke's International University, Tokyo, Japan.""}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12502']
1446,35678800,Effects of Orlistat or Telmisartan on the Serum Free Fatty Acids in Non-alcoholic Fatty Liver Disease Patients: An Open-Labeled Randomized Controlled Study.,"BACKGROUND


One of the important inducers of inflammatory responses and accumulation of fat in hepatocytes is free fatty acids which ultimately lead to the development of non-alcoholic fatty liver disease. Patients with non-alcoholic fatty liver disease have high levels of plasma free fatty acids which are usually associated with type 2 diabetes and components of metabolic syndrome including dyslipidemia. Objective of this research is to investigate the effects of orlistat (a lipase enzyme inhibitor) or telmisartan (an angiotensin receptor blocker) on the serum free fatty acids in non-alcoholic fatty liver disease patients taking into consideration the baseline lipid profile.
METHODS


This open-label clinical trial was carried out in the Department of Pharmacology, College of Medicine at the University of Sulaimani in cooperation with Shar Teaching Hospital in Sulaimani city-Kurdistan Region of Iraq. A total number of 74 non-alcoholic fatty liver disease patients were recruited and grouped randomly into group I (n = 25) treated with orlistat (120 mg/day orally) for 12 weeks, group II (n = 24) treated with telmisartan (20 mg/day orally) for 8 weeks, and group III (n = 25) treated with placebo (carboxy- methyl cellulose) once daily. Fasting serum level of free fatty acid and lipid profile including total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoproteins were determined.
RESULTS


Orlistat and telmisartan significantly reduced the triglyceride-glucose index and free fatty acid levels (P < .001) in patients with non-alcoholic fatty liver diseases.
CONCLUSION


Short-term treatment with orlistat or telmisartan produce effective and significant reductions in FFAs in patients with non-alcoholic fatty liver disease compared to placebo. Orlistat effectively reduces the free fatty acid irrespective of the baseline lipid profile.",2022,"RESULTS


Orlistat and telmisartan significantly reduced the triglyceride-glucose index and free fatty acid levels (P < .001) in patients with non-alcoholic fatty liver diseases.
","['Non-alcoholic Fatty Liver Disease Patients', 'patients with non-alcoholic fatty liver disease', 'Department of Pharmacology, College of Medicine at the University of Sulaimani in cooperation with Shar Teaching Hospital in Sulaimani city-Kurdistan Region of Iraq', 'non-alcoholic fatty liver disease patients taking into consideration the baseline lipid profile', 'Patients with non-alcoholic fatty liver disease', 'A total number of 74 non-alcoholic fatty liver disease patients']","['telmisartan (an angiotensin receptor blocker', 'orlistat', 'orlistat or telmisartan', 'Orlistat or Telmisartan', 'placebo (carboxy- methyl cellulose', 'Orlistat', 'Orlistat and telmisartan', 'placebo', 'telmisartan']","['Serum Free Fatty Acids', 'Fasting serum level of free fatty acid and lipid profile including total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoproteins', 'free fatty acid', 'FFAs', 'triglyceride-glucose index and free fatty acid levels']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0076275', 'cui_str': 'orlistat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025729', 'cui_str': 'Methylcellulose'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1278072', 'cui_str': 'Serum free fatty acid measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1535899', 'cui_str': 'Non-high-density lipoprotein cholesterol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.158949,"RESULTS


Orlistat and telmisartan significantly reduced the triglyceride-glucose index and free fatty acid levels (P < .001) in patients with non-alcoholic fatty liver diseases.
","[{'ForeName': 'Vian Ahmed', 'Initials': 'VA', 'LastName': 'Wasta Esmail', 'Affiliation': 'Department of Clinical Pharmacy, University of Sulaimani School of Pharmacy, Sulaimani-Iraq.'}, {'ForeName': 'Marwan S M', 'Initials': 'MSM', 'LastName': 'Al-Nimer', 'Affiliation': 'Department of Pharmacology and Toxicology, Hawler Medical University School of Pharmacy, Erbil-Iraq.'}, {'ForeName': 'Mohammed Omer', 'Initials': 'MO', 'LastName': 'Mohammed', 'Affiliation': 'Department of Medicine, University of Sulaimani School of Medicine, Sulaimani-Iraq.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.19365']
1447,35679283,Improving outcomes for care partners of persons with traumatic brain injury: Protocol for a randomized control trial of a just-in-time-adaptive self-management intervention.,"Informal family care partners of persons with traumatic brain injury (TBI) often experience intense stress resulting from their caregiver role. As such, there is a need for low burden, and easy to engage in interventions to improve health-related quality of life (HRQOL) for these care partners. This study is designed to evaluate the effectiveness of a personalized just-in-time adaptive intervention (JITAI) aimed at improving the HRQOL of care partners. Participants are randomized either to a control group, where they wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback), or the JITAI group, where they wear the Fitbit®, provide daily reports of HRQOL and receive personalized self-management pushes for 6 months. 240 participants will be enrolled (n = 120 control group; n = 120 JITAI group). Outcomes are collected at baseline, 1-, 2-, 3-, 4-, 5- & 6-months, as well as 3- and 6-months post intervention. We hypothesize that the care partners who receive the intervention (JITAI group) will show improvements in caregiver strain (primary outcome) and mental health (depression and anxiety) after the 6-month (180 day) home monitoring period. Participant recruitment for this study started in November 2020. Data collection efforts should be completed by spring 2025; results are expected by winter 2025. At the conclusion of this randomized control trial, we will be able to identify care partners at greatest risk for negative physical and mental health outcomes, and will have demonstrated the efficacy of this JITAI intervention to improve HRQOL for these care partners. Trial registration: ClinicalTrial.gov NCT04570930; https://clinicaltrials.gov/ct2/show/NCT04570930.",2022,This study is designed to evaluate the effectiveness of a personalized just-in-time adaptive intervention (JITAI) aimed at improving the HRQOL of care partners.,"['240 participants will be enrolled (n = 120 control group; n = 120 JITAI group', 'Informal family care partners of persons with traumatic brain injury (TBI', 'care partners of persons with traumatic brain injury']","['personalized just-in-time adaptive intervention (JITAI', 'just-in-time-adaptive self-management intervention', 'Fitbit® and provide daily reports of HRQOL']",['caregiver strain (primary outcome) and mental health (depression and anxiety'],"[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",240.0,0.0828766,This study is designed to evaluate the effectiveness of a personalized just-in-time adaptive intervention (JITAI) aimed at improving the HRQOL of care partners.,"[{'ForeName': 'Noelle E', 'Initials': 'NE', 'LastName': 'Carlozzi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Angelle M', 'Initials': 'AM', 'LastName': 'Sander', 'Affiliation': 'H. Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine/Harris Health System, Houston, Texas, United States of America.'}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Zhenke', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Miner', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Angela K', 'Initials': 'AK', 'LastName': 'Lyden', 'Affiliation': 'Clinical Trials Support Office, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Graves', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, Michigan, United States of America.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States of America.'}]",PloS one,['10.1371/journal.pone.0268726']
1448,35679489,Simulation-Based Mastery Learning Improves the Performance of Donning and Doffing of Personal Protective Equipment by Medical Students.,"INTRODUCTION


Medical students lack adequate training on how to correctly don and doff personal protective equipment (PPE). Simulation-based mastery learning (SBML) is an effective technique for procedural education. The aim of this study was to determine whether SBML improves proper PPE donning and doffing by medical students.
METHODS


This was a prospective, pre-test/post-test study of 155 medical students on demonstration of correct PPE use before and after a SBML intervention. Subjects completed standard hospital training by viewing a US Centers for Disease Control and Prevention training video on proper PPE use prior to the intervention. They then participated in a SBML training session that included baseline testing, deliberate practice with expert feedback, and post-testing until mastery was achieved. Students were assessed using a previously developed 21-item checklist on donning and doffing PPE with a minimum passing standard (MPS) of 21/21 items. We analyzed differences between pre-test and post-test scores using paired t-tests. Students at preclinical and clinical levels of training were compared with an independent t-test.
RESULTS


Two participants (1.3%) met the MPS on pre-test. Of the remaining 153 subjects who participated in the intervention, 151 (98.7%) reached mastery. Comparison of mean scores from pre-test to final post-test significantly improved from an average raw score of 12.55/21 (standard deviation [SD] = 2.86), to 21/21(SD = 0), t(150) = 36.3, P <0.001. There was no difference between pre-test scores of pre-clinical and clinical students.
CONCLUSION


Simulation-based mastery learning improves medical student performance in PPE donning and doffing in a simulated environment. This approach standardizes PPE training for students in advance of clinical experiences.",2022,"There was no difference between pre-test scores of pre-clinical and clinical students.
","['153 subjects who participated in the intervention, 151 (98.7%) reached mastery', 'students in advance of clinical experiences', '155 medical students on demonstration of correct PPE use before and after a SBML intervention', 'Medical Students']","['Simulation-based mastery learning', 'standard hospital training by viewing a US Centers for Disease Control and Prevention training video', 'Simulation-based mastery learning (SBML', 'Simulation-Based Mastery Learning', 'SBML']",['medical student performance'],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1960806', 'cui_str': 'Protective equipment used'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0038495', 'cui_str': 'Medical student'}]",155.0,0.0208188,"There was no difference between pre-test scores of pre-clinical and clinical students.
","[{'ForeName': 'Danielle T', 'Initials': 'DT', 'LastName': 'Miller', 'Affiliation': 'University of Colorado School of Medicine, Department of Emergency Medicine, Denver, Colorado.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pokrajac', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ngo', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Gallegos', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Dixon', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}, {'ForeName': 'Kelly N', 'Initials': 'KN', 'LastName': 'Roszczynialski', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}, {'ForeName': 'Nounou', 'Initials': 'N', 'LastName': 'Taleghani', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gisondi', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}]",The western journal of emergency medicine,['10.5811/westjem.2022.2.54748']
1449,35685584,The Clinical Risk Factors of Adenovirus Pneumonia in Children Based on the Logistic Regression Model: Correlation with Lactate Dehydrogenase.,"Methods


Children with bacterial pneumonia (41 cases) and adenovirus pneumonia (179 cases) hospitalized in Tianjin Children's Hospital from January to October 2020 were selected. The differences in baseline and clinical characteristics between children with two pneumonias, respectively, were compared via the chi-square test and Wilcox test. The Least Absolute Shrinkage and Selection Operator (LASSO) model was applied to screen the pneumonia type-related characteristics. Patients were randomly divided into the training set ( n  = 154) and test set ( n  = 66). The logistic model was constructed using the screened characteristics in the training set to predict whether the cases are bacterial pneumonia or adenovirus pneumonia. Finally, the model was validated by receiver operating characteristic (ROC) curve and area under curve (AUC) in the test set.
Results


The age ( p  < 0.001), hospital stay ( p  < 0.001), tonsil condition ( p  < 0.001), interleukin-6 (IL-6;  p =0.033), and lactate dehydrogenase (LDH;  p  < 0.001) between children with bacterial pneumonia and adenovirus pneumonia were significantly different. Sex, tonsil condition, age, hospital stay, r-glutamyltransferase (r-GT), and LDH levels were the factors associated with the types of pneumonia. Compared with bacterial pneumonia, children with adenovirus pneumonia were younger (OR = 0.207, 95% CI: 0.041-0.475), with longer hospital stay (OR = 7.974, 95% CI: 2.626-74.354) and higher LDH expression level (OR = 1.025, 95% CI: 1.006-1.060). 92.4% types of pneumonia were correctly predicted, and the AUC value of the model was 0.981.
Conclusion


The LDH level was the associated factor to predict the types of pneumonia. Adenovirus pneumonia was associated with earlier age and longer hospital stay than bacterial pneumonia. The established model can well predict the types of pneumonia in children and provide clinical basis for guiding the individualized treatment of children.",2022,"Compared with bacterial pneumonia, children with adenovirus pneumonia were younger (OR = 0.207, 95% CI: 0.041-0.475), with longer hospital stay (OR = 7.974, 95% CI: 2.626-74.354) and higher LDH expression level (OR = 1.025, 95% CI: 1.006-1.060).","[""Children with bacterial pneumonia (41 cases) and adenovirus pneumonia (179 cases) hospitalized in Tianjin Children's Hospital from January to October 2020 were selected""]",[],"['LDH level', 'higher LDH expression level', 'lactate dehydrogenase', 'Adenovirus pneumonia', 'bacterial pneumonia and adenovirus pneumonia', 'longer hospital stay', 'receiver operating characteristic (ROC) curve and area under curve (AUC', 'Sex, tonsil condition, age, hospital stay, r-glutamyltransferase (r-GT), and LDH levels', 'hospital stay ', 'tonsil condition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0276156', 'cui_str': 'Adenoviral pneumonia'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]",[],"[{'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0276156', 'cui_str': 'Adenoviral pneumonia'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}]",,0.0580341,"Compared with bacterial pneumonia, children with adenovirus pneumonia were younger (OR = 0.207, 95% CI: 0.041-0.475), with longer hospital stay (OR = 7.974, 95% CI: 2.626-74.354) and higher LDH expression level (OR = 1.025, 95% CI: 1.006-1.060).","[{'ForeName': 'Yuqiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Tianjin Children's Hospital, 238 Longyan Road, Beichen District, Tianjin, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Infectious Diseases, Tianjin Children's Hospital, 238 Longyan Road, Beichen District, Tianjin, China.""}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Wei', 'Affiliation': ""Department of Infectious Diseases, Tianjin Children's Hospital, 238 Longyan Road, Beichen District, Tianjin, China.""}]",International journal of clinical practice,['10.1155/2022/3001013']
1450,35685573,Efficacy of Adjuvant Tamsulosin for Improving the Stone-Free Rate after Extracorporeal Shock Wave Lithotripsy in Renal Stones: A Randomized Controlled Trial.,"Introduction


Extracorporeal shock wave lithotripsy (ESWL) is an effective treatment for urolithiasis. Tamsulosin is capable of causing dilation and facilitating the migration of stones. The aim of this study is to evaluate the efficacy of adjuvant treatment with tamsulosin for improving the stone-free rate after a single session of ESWL in the treatment of kidney stones.
Methods


This is a randomized, nonplacebo-controlled study with a sample of 60 adults with a single radiopaque kidney stone of 5-20 mm in diameter. After the ESWL session, the patients were divided into two groups. The control group received standard treatment for analgesia consisting of oral diclofenac (75 mg/12 h) as needed. The tamsulosin group received standard treatment for analgesia plus oral tamsulosin (0.4 mg/day) for eight weeks. In both groups, stone-free status was determined using a CT scan eight weeks after ESWL. The protocol of this study was registered with ClinicalTrials.gov, identifier: NCT04819828.
Results


Only 57 patients completed the study (28 tamsulosin and 29 control). Overall, the average stone diameter was 11.42 ± 4.52 mm. The stone-free rate was 50.88% (29 of 57) overall, 53.57% (15 of 28) for the tamsulosin group, and 48.27% (14 of 29) for the control group ( p  = 0.680). The estimated relative risk in favor of the tamsulosin group to achieve a stone-free status was 1.11 (95% CI 0.67-1.9). The estimated number needed to treat to achieve a single patient with renal stone-free status after eight weeks of ESWL adjuvant treatment with tamsulosin was 19.
Conclusion


Our findings suggest that tamsulosin as adjuvant treatment after a single ESWL session is well tolerated and safe, but it does not increase the stone-free rate in patients with a single radiopaque renal stone of 5-20 mm in diameter. Our results may support the use of tamsulosin with ESWL in the case of patients with a single radiopaque renal stone of 11-20 mm in diameter based on an apparent higher stone-free rate and a low rate of complications.",2022,"The stone-free rate was 50.88% (29 of 57) overall, 53.57% (15 of 28) for the tamsulosin group, and 48.27% (14 of 29) for the control group ( p  = 0.680).","['60 adults with a single radiopaque kidney stone of 5-20\u2009mm in diameter', 'kidney stones', '57 patients completed the study (28 tamsulosin and 29 control', 'Renal Stones']","['tamsulosin', 'Tamsulosin', 'standard treatment for analgesia consisting of oral diclofenac', 'Extracorporeal shock wave lithotripsy (ESWL', 'Extracorporeal Shock Wave Lithotripsy', 'ESWL', 'analgesia plus oral tamsulosin', 'tamsulosin with ESWL', 'Adjuvant Tamsulosin']","['average stone diameter', 'stone-free rate', 'tolerated and safe']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",60.0,0.169844,"The stone-free rate was 50.88% (29 of 57) overall, 53.57% (15 of 28) for the tamsulosin group, and 48.27% (14 of 29) for the control group ( p  = 0.680).","[{'ForeName': 'Rafael Edgardo', 'Initials': 'RE', 'LastName': 'Maldonado-Valadez', 'Affiliation': 'Department of Urology, Hospital Regional de Alta Especialidad Del Bajío, Leon, Mexico.'}, {'ForeName': 'Angel David', 'Initials': 'AD', 'LastName': 'Valdez-Vargas', 'Affiliation': 'Department of Urology, Hospital Regional de Alta Especialidad Del Bajío, Leon, Mexico.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Alvarez', 'Affiliation': 'Universidad de Guanajuato, Leon, Mexico.'}, {'ForeName': 'Edel Rafael', 'Initials': 'ER', 'LastName': 'Rodea-Montero', 'Affiliation': 'Universidad de Guanajuato, Leon, Mexico.'}]",International journal of clinical practice,['10.1155/2022/3757588']
1451,35685566,Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial.,"Background


Overactive bladder (OAB) is characterized by urgency and frequency with (OAB wet) or without (OAB dry) urge urinary incontinence (UUI). In the phase 3 EMPOWUR trial, vibegron-a selective  β   3 -adrenergic receptor agonist for the treatment of OAB-significantly improved daily number of urgency episodes and micturitions vs. placebo ( P  < 0.01). These post hoc analyses aimed to compare the efficacy of vibegron vs. placebo in OAB dry and wet populations.
Methods


Patients were randomly assigned 5:5:4 to receive once-daily vibegron 75 mg, placebo, or tolterodine 4 mg extended release, respectively, for 12 weeks. Baseline criteria for OAB dry included an average of ≥8 micturitions, ≥3 urgency episodes, and <1 UUI episode per diary day and for OAB wet included an average of ≥8 micturitions and ≥1 UUI episode per diary day. Change from baseline in mean daily number of urgency episodes and micturitions was assessed in both populations.
Results


Of the 1463 patients included in the full analysis set, 336 (23%) had OAB dry (vibegron,  N  = 123; placebo,  N  = 115; and tolterodine,  N  = 98), and 1127 (77%) had OAB wet (vibegron,  N  = 403; placebo,  N  = 405; and tolterodine,  N  = 319). Vibegron was associated with significant reductions (95% CIs of the least squares mean differences [LSMD] does not include 0) from baseline at week 12 vs. placebo in mean daily urgency episodes for the dry (LSMD [95% CI], ‒1.0 [‒2.0, ‒0.1]) and wet (‒0.6 [‒1.0, ‒0.1]) populations. Vibegron was associated with significant reductions from baseline at week 12 vs. placebo in mean daily micturitions for the dry (LSMD [95% CI], ‒0.8 [‒1.5, ‒ 0.1]) and wet (‒0.5 [‒0.8, ‒0.1]) populations. There were no significant differences in either outcome between tolterodine and placebo for either the dry or wet populations in this study.
Conclusions


In this subgroup analysis from the EMPOWUR trial, vibegron was associated with significant reductions compared with placebo in urgency episodes and micturitions in both the OAB dry and wet populations, suggesting that vibegron is similarly efficacious for these endpoints in patients with and without UUI. This trial is registered with NCT03492281.",2022,"There were no significant differences in either outcome between tolterodine and placebo for either the dry or wet populations in this study.
","['Patients with Dry and Wet Overactive Bladder', 'patients with and without UUI']","['placebo', 'vibegron vs. placebo', 'tolterodine and placebo', 'once-daily vibegron 75\u2009mg, placebo, or tolterodine']","['mean daily urgency episodes', 'urgency and frequency with (OAB wet) or without (OAB dry) urge urinary incontinence (UUI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}]",1463.0,0.59947,"There were no significant differences in either outcome between tolterodine and placebo for either the dry or wet populations in this study.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Frankel', 'Affiliation': 'Seattle Urology Research Center, Seattle, WA, USA.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Varano', 'Affiliation': 'Clinical Research Consulting, Milford, CT, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kennelly', 'Affiliation': 'Carolinas Medical Center, Charlotte, NC, USA.'}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Matt T', 'Initials': 'MT', 'LastName': 'Rosenberg', 'Affiliation': 'Mid-Michigan Health Centers, Jackson, MI, USA.'}, {'ForeName': 'Denise D', 'Initials': 'DD', 'LastName': 'Shortino', 'Affiliation': 'Urovant Sciences, Irvine, CA, USA.'}, {'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Jankowich', 'Affiliation': 'Urovant Sciences, Irvine, CA, USA.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mudd', 'Affiliation': 'Urovant Sciences, Irvine, CA, USA.'}]",International journal of clinical practice,['10.1155/2022/6475014']
1452,35685555,Efficacy of Pharmaceutical Care in Patients with Type 2 Diabetes Mellitus and Hypertension: A Randomized Controlled Trial.,"Background


The rates of treatment adherence and treat-to-target rates of blood pressure and blood glucose-related indexes in patients with hypertension and type 2 diabetes mellitus (T2DM) are associated with prognosis. This study aimed to investigate the efficacy of pharmaceutical care postdischarge for treatment adherence in hypertensive patients with type 2 diabetes mellitus (T2DM).
Methods


This was a randomized controlled trial of patients with combined T2DM and hypertension treated between January and May 2018. Pharmaceutical care included free access to a clinical pharmacist, education material, a WeChat account for live discussion, and a telephone follow-up. The primary endpoint was the 3-month medication adherence. The secondary endpoints included the achieving levels of target rates and values of fasting plasma glucose (FPG), 2 h postprandial glucose (2hPG), and hemoglobin A1c (HbA1c) and the rates of reaching the achieving target rate of blood pressure target <130/80.
Results


In 80 participants, the 3-month medication adherence was higher in the pharmaceutical care group than the routine group (90.0% vs. 52.5%,  P  < 0.001). In terms of FPG, 2hPG, and HbA1c, there were also significant differences between the pharmaceutical care and routine groups (FPG, 6.50 (6.00, 7.18) vs. 7.00 (6.83, 7.78) mmol/L,  P =0.004; 2hPG, 8.45 (7.45, 9.28) vs. 9.35 (8.23, 10.15),  P =0.007; HbA1c, 6.5% (6.3%, 7.0%) vs. 7.0% (6.5%, 7.4%),  P =0.007). The achieving target rate of reaching the blood pressure target in the pharmaceutical care group (92.5%) was significantly higher than that in the routine group (62.5%;  P  < 0.05).
Conclusion


The postdischarge pharmaceutical care program in patients with T2DM and hypertension improves medication adherence.",2022,"In terms of FPG, 2hPG, and HbA1c, there were also significant differences between the pharmaceutical care and routine groups (FPG, 6.50 (6.00, 7.18) vs. 7.00 (6.83, 7.78) mmol/L,  P =0.004; 2hPG, 8.45 (7.45, 9.28) vs. 9.35 (8.23, 10.15),  P =0.007; HbA1c, 6.5% (6.3%, 7.0%) vs. 7.0% (6.5%, 7.4%),  P =0.007).","['patients with T2DM and hypertension improves medication adherence', 'Patients with Type 2 Diabetes Mellitus and Hypertension', 'patients with combined T2DM and hypertension treated between January and May 2018', 'patients with hypertension and type 2 diabetes mellitus (T2DM', 'hypertensive patients with type 2 diabetes mellitus (T2DM']","['Pharmaceutical Care', 'pharmaceutical care postdischarge']","['achieving target rate of reaching the blood pressure target', '3-month medication adherence', 'achieving levels of target rates and values of fasting plasma glucose (FPG), 2\u2009h postprandial glucose (2hPG), and hemoglobin A1c (HbA1c) and the rates of reaching the achieving target rate of blood pressure target <130/80', 'rates of treatment adherence and treat-to-target rates of blood pressure and blood glucose-related indexes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.175421,"In terms of FPG, 2hPG, and HbA1c, there were also significant differences between the pharmaceutical care and routine groups (FPG, 6.50 (6.00, 7.18) vs. 7.00 (6.83, 7.78) mmol/L,  P =0.004; 2hPG, 8.45 (7.45, 9.28) vs. 9.35 (8.23, 10.15),  P =0.007; HbA1c, 6.5% (6.3%, 7.0%) vs. 7.0% (6.5%, 7.4%),  P =0.007).","[{'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Geng', 'Affiliation': ""Department of Pharmacy, The Second People's Hospital of Dongying, Dongying, China.""}, {'ForeName': 'Chenjing', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ""Department of Pharmacy, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Quality Management, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Dongying People's Hospital, Dongying, China.""}]",International journal of clinical practice,['10.1155/2022/7681404']
1453,35685534,The Effects of Probiotic Supplementation on Opioid-Related Disorder in Patients under Methadone Maintenance Treatment Programs.,"Introduction


Patients under methadone maintenance treatment programs (MMTPs) are susceptible to numerous complications (e.g., mental and metabolic disorders). This study evaluated the effects of probiotics on clinical symptoms, biomarkers of oxidative stress, inflammation, insulin resistance, and serum lipid content in patients receiving MMTPs.
Materials and Methods


A randomized, double-blind, placebo-controlled trial was conducted among 70 patients receiving MMTPs to receive either 1.8 × 10 9  CFU/day probiotics ( n  = 35) or placebo ( n  = 35) for 12 weeks. Clinical symptoms and metabolic profiles were measured before and after the intervention in patients receiving MMTPs.
Results


Compared with the placebo group, probiotic supplementation resulted in a significant improvement in the severity of depression ( P  < 0.05). In addition, probiotic administration significantly decreased fasting plasma glucose (FPG), total cholesterol, and low-density lipoprotein cholesterol (LDL cholesterol) ( P  < 0.05). Furthermore, probiotics resulted in a significant reduction in high-sensitivity C-reactive protein (hs-CRP) and a significant elevation in total antioxidant capacity (TAC) and total glutathione (GSH) levels ( P  < 0.05).
Conclusion


Treatment with probiotics for 12 weeks to patients receiving MMTPs had beneficial effects on symptoms of depression, as well as several metabolic profiles. Clinical Trial Registration: this study was registered in the Iranian website (https://www.irct.ir) for clinical trials registration (https://fa.irct.ir/trial/46363/IRCT20170420033551N9). The registration date is March 22, 2020.",2022,"Furthermore, probiotics resulted in a significant reduction in high-sensitivity C-reactive protein (hs-CRP) and a significant elevation in total antioxidant capacity (TAC) and total glutathione (GSH) levels ( P  < 0.05).
","['70 patients receiving MMTPs to receive either 1.8\u2009×\u200910 9 \u2009CFU/day probiotics ( n \u2009=\u200935) or', 'Patients under Methadone Maintenance Treatment Programs', 'patients receiving MMTPs']","['probiotics', 'Probiotic Supplementation', 'MMTPs', 'methadone maintenance treatment programs (MMTPs', 'probiotic supplementation', 'placebo']","['clinical symptoms, biomarkers of oxidative stress, inflammation, insulin resistance, and serum lipid content', 'fasting plasma glucose (FPG), total cholesterol, and low-density lipoprotein cholesterol (LDL cholesterol', 'symptoms of depression', 'total antioxidant capacity (TAC) and total glutathione (GSH) levels', 'severity of depression', 'high-sensitivity C-reactive protein (hs-CRP', 'Clinical symptoms and metabolic profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",,0.264015,"Furthermore, probiotics resulted in a significant reduction in high-sensitivity C-reactive protein (hs-CRP) and a significant elevation in total antioxidant capacity (TAC) and total glutathione (GSH) levels ( P  < 0.05).
","[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Molavi', 'Affiliation': 'Department of Addiction Studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Morad', 'Initials': 'M', 'LastName': 'Rasouli-Azad', 'Affiliation': 'International Center for Comparative Criminology, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mirzaei', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Amir Hassan', 'Initials': 'AH', 'LastName': 'Matini', 'Affiliation': 'Department of Clinical Pathology, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Department of Addiction Studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Valiollahzadeh', 'Affiliation': 'Student Research Committee, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Hassanzadeh', 'Affiliation': 'Department of Addiction Studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Saghazade', 'Affiliation': 'Student Research Committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Abbaszadeh-Mashkani', 'Affiliation': 'Trauma Nursing Research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Mamsharifi', 'Affiliation': ""Department of Psychology, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Addiction Studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}]",International journal of clinical practice,['10.1155/2022/1206914']
1454,35685530,The Impact of Telemonitoring on Improving Glycemic and Metabolic Control in Previously Lost-to-Follow-Up Patients with Type 2 Diabetes Mellitus: A Single-Center Interventional Study in the United Arab Emirates.,"Background


Telemonitoring (TM), mobile-phone technology for health, and bluetooth-enabled self-monitoring devices represent innovative solutions for proper glycemic control, compliance and monitoring, and access to providers.
Objective


In this study, we evaluated the impact of TM devices on glycemic control and the compliance of 38 previously lost-to-follow-up (LTFU) patients with type 2 diabetes mellitus (T2DM).
Methods


This was an interventional single-center study that randomly recruited LTFU patients from the Dubai Diabetes Center (DDC), UAE. After contact and recruitment by phone, patients had an initial visit at which they were provided with home-based TM devices. A follow-up visit was conducted three months later.
Results


The mean HbA1c decreased significantly from 10.3 ± 1.9% at baseline to 7.4 ± 1.5% at the end of follow-up, with a mean difference (MD) of -2.9% [95% CI: -3.6 to -2.2]. The percentage of patients with HbA1c <7% was 50% after three months. Home-based blood sugar monitor devices showed a significant reduction in fasting blood glucose (FBG) after three months (MD = -40.1 mg/dL, 95% CI: -70.8 to -9.3). A significant reduction was observed in terms of body weight after three months (MD = -1.3 kg, 95% CI: -2.5 to -0.08). The mean number of days the participants used a device was the highest for portable pill dispensers (86.5 ± 22.8 days), followed by a OneTouch® blood glucose monitor (72.9 ± 23.5 days).
Conclusions


TM led to significant improvements in overall diabetes outcomes, including glycemic control and body weight, indicating its effectiveness in a challenging population of T2DM patients who had previously been lost to follow-up.",2022,"A significant reduction was observed in terms of body weight after three months (MD = -1.3 kg, 95% CI: -2.5 to -0.08).","['Previously Lost-to-Follow-Up Patients with Type 2 Diabetes Mellitus', 'randomly recruited LTFU patients from the Dubai Diabetes Center (DDC), UAE', '38 previously lost-to-follow-up (LTFU) patients with type 2 diabetes mellitus (T2DM']","['TM devices', '\n\n\nTelemonitoring (TM), mobile-phone technology', 'Telemonitoring']","['glycemic control and body weight', 'fasting blood glucose (FBG', 'overall diabetes outcomes', 'body weight', 'mean HbA1c']","[{'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0425168,"A significant reduction was observed in terms of body weight after three months (MD = -1.3 kg, 95% CI: -2.5 to -0.08).","[{'ForeName': 'Muhammad Hamed', 'Initials': 'MH', 'LastName': 'Farooqi', 'Affiliation': 'Dubai Diabetes Center, Dubai Health Authority, Dubai, UAE.'}, {'ForeName': 'Dima Kamal', 'Initials': 'DK', 'LastName': 'Abdelmannan', 'Affiliation': 'Dubai Diabetes Center, Dubai Health Authority, Dubai, UAE.'}, {'ForeName': 'Manal Mubarak', 'Initials': 'MM', 'LastName': 'Al Buflasa', 'Affiliation': 'Dubai Diabetes Center, Dubai Health Authority, Dubai, UAE.'}, {'ForeName': 'Moataz Abdalla', 'Initials': 'MA', 'LastName': 'Abbas Hamed', 'Affiliation': 'Dubai Diabetes Center, Dubai Health Authority, Dubai, UAE.'}, {'ForeName': 'Maxon', 'Initials': 'M', 'LastName': 'Xavier', 'Affiliation': 'Dubai Diabetes Center, Dubai Health Authority, Dubai, UAE.'}, {'ForeName': 'Tessa Joyce', 'Initials': 'TJ', 'LastName': 'Santos Cadiz', 'Affiliation': 'Dubai Diabetes Center, Dubai Health Authority, Dubai, UAE.'}, {'ForeName': 'Faisal Amir', 'Initials': 'FA', 'LastName': 'Nawaz', 'Affiliation': 'Cognitive Healthcare International, Dubai, UAE.'}]",International journal of clinical practice,['10.1155/2022/6286574']
1455,35685524,"Efficacy of the Synbiotic Supplementation on the Metabolic Factors in Patients with Metabolic Syndrome: A Randomized, Triple-Blind, Placebo-Controlled Trial.","Background


Metabolic syndrome is overwhelmingly increasing and is a significant risk factor for cardiovascular disorder, so effective treatment strategies are considered high priority. This study aimed to determine the effects of synbiotic supplementation on metabolic factors in patients with metabolic syndrome.
Methods


In this triple-blind, randomized, placebo-controlled, clinical trial, 108 participants were divided into two groups to receive synbiotic supplementation or placebo for 12 weeks. All participants were also educated about maintaining a healthy lifestyle and consuming low-calorie nutritious meals, along with dietary intake and physical activity monitoring. Anthropometric measures, blood pressure, glycemic indices, lipid profile, hepatic enzymes, and hs-CRP were evaluated at the baseline and end of the trial.
Results


Synbiotic supplementation significantly reduces fasting blood glucose (FBG) levels in the intervention group versus placebo group [-14.69 ± 15.11 mg/dl vs. -8.23 ± 7.90 mg/dl;  p =0.007], but there was no difference between groups in other metabolic factors.
Conclusions


These findings suggest that synbiotic supplementation while following a healthy lifestyle and nutrition improved FBG in patients with metabolic syndrome.",2022,"Anthropometric measures, blood pressure, glycemic indices, lipid profile, hepatic enzymes, and hs-CRP were evaluated at the baseline and end of the trial.
","['108 participants', 'patients with metabolic syndrome', 'Patients with Metabolic Syndrome']","['Synbiotic Supplementation', 'Synbiotic supplementation', 'synbiotic supplementation or placebo', 'synbiotic supplementation', 'placebo', 'Placebo']","['Anthropometric measures, blood pressure, glycemic indices, lipid profile, hepatic enzymes, and hs-CRP', 'fasting blood glucose (FBG) levels', 'Metabolic Factors', 'metabolic factors']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",108.0,0.204272,"Anthropometric measures, blood pressure, glycemic indices, lipid profile, hepatic enzymes, and hs-CRP were evaluated at the baseline and end of the trial.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rahimi', 'Affiliation': 'Nutritional Sciences Department, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Pasdar', 'Affiliation': 'Nutritional Sciences Department, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'School of Nutrition and Dietetics, Acadia University, Wolfville, NS, Canada.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Abbasi', 'Affiliation': 'Nutritional Sciences Department, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Fry', 'Affiliation': 'School of Nutrition and Dietetics, Acadia University, Wolfville, NS, Canada.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mansoaur', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Department of Biostatistics, Medical School, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Seyed Mostafa', 'Initials': 'SM', 'LastName': 'Nachvak', 'Affiliation': 'Nutritional Sciences Department, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadi', 'Affiliation': 'Food Sciences Department, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",International journal of clinical practice,['10.1155/2022/2967977']
1456,35685522,Dietary Pattern or Weight Loss: Which One Is More Important to Reduce Disease Activity Score in Patients with Rheumatoid Arthritis? A Randomized Feeding Trial.,"Objectives


Herein, disease activity score 28 (DAS 28) was compared between patients with rheumatoid arthritis (RA) receiving the Mediterranean dietary pattern (MD) and low-fat diet.  Subjects/Methods . Overweight and obese RA patients aged 15-75 y participated in this randomized feeding trial. Participants were randomized to MD ( n  = 51) and low-fat high-carbohydrate diet ( n  = 53) for 12 weeks. The control group followed their regular diet ( n  = 50). Participants completed the form of tender and swollen joint counts before the study enrollment and after 12 weeks to compute DAS 28.
Results


Weight loss was not statistically significant between the MD and LF-HC groups. DAS 28 significantly decreased in MD compared to the LF-HC group ( p =0.02) and controls ( p =0.001). Adjusting for the baseline variables, MD reduced DAS 28 by 76% (95% CI = -0.45, -0.2;  p =0.03) after 12 weeks of intervention. The baseline serum ESR level showed 99.8% effect on DAS 28 score at the end (95% CI = 0.014, 0.035;  p  < 0.001).
Conclusions


The MD showed beneficial effects on DAS 28 compared to the LF-HC diet in patients with RA, regardless of weight loss. It is a better dietary choice for pain reduction in patients with RA. The trial is registered at Iranian Registry of Clinical Trials (IRCT20200929048876N2).",2022,DAS 28 significantly decreased in MD compared to the LF-HC group ( p =0.02) and controls ( p =0.001).,"['Patients with Rheumatoid Arthritis', 'Overweight and obese RA patients aged 15-75', 'patients with rheumatoid arthritis (RA) receiving the Mediterranean dietary pattern (MD) and low-fat diet', 'patients with RA']","['low-fat high-carbohydrate diet', 'regular diet']","['Dietary Pattern or Weight Loss', 'baseline serum ESR level', 'weight loss', 'Disease Activity Score', 'MD', 'Weight loss', 'pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.190246,DAS 28 significantly decreased in MD compared to the LF-HC group ( p =0.02) and controls ( p =0.001).,"[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Internal Medicine, Vali-e-Asr Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Tabatabaiee', 'Affiliation': 'Department of Internal Medicine, Vali-e-Asr Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Mir Ali', 'Initials': 'MA', 'LastName': 'Mousavi', 'Affiliation': 'Department of General Surgery, Ayatollah Mousavi Hospital, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Seyedeh Neda', 'Initials': 'SN', 'LastName': 'Mousavi', 'Affiliation': 'Zanjan Metaboilc Diseases Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Somayae', 'Initials': 'S', 'LastName': 'Abdollahi Sabet', 'Affiliation': 'Department of Community Medicine, School of Medicine, Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Jalili', 'Affiliation': 'Department of Internal Medicine, Vali-e-Asr Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}]",International journal of clinical practice,['10.1155/2022/6004916']
1457,35685760,Using Digital Platform Approach to Reduce Salt Intake in a Sample of UAE Population: An Intervention Study.,"Background


Non-communicable diseases (NCDs) are the leading causes of mortality globally, accounting for more deaths than all other causes combined. World Health Organization launched its initiative in 2013 to reduce the intake of salt, the number of countries that have national sodium reduction strategies reached to 89 countries in 2017. In 2020, a study conducted in UAE showed more than 65% of the population exceeded WHO recommendations for salt intake. This study aimed to measure effectiveness of using digital platform approach to deliver educational materials to facilitate salt reduction in a sample of UAE population.
Methods


A controlled parallel intervention study was conducted in 2020. A sample of 121 participants completed the study and fulfilled the inclusion criteria with female to male ratio of (0.95:1.05). Participants were distributed randomly into three groups Control group, WhatsApp group, and Electronic Brochures group. Educational materials were distributed among participants of WhatsApp and Electronic brochures groups for 6-weeks. 24-h urinary excretion for sodium, potassium and creatinine, were measured in addition to KAP questionnaire and physical activity on two occasions at baseline and endpoint after 10-weeks (6-weeks of educational intervention).
Results


Both intervention groups showed a reduction in sodium with 278 mg ( p  < 0.001) for WhatsApp group ( n  = 41) and 169 mg ( p  < 0.018) for Electronic brochures group ( n  = 41), while Control group didn't show any significant change. Moreover, the percentage of participants exceeding WHO recommendation of sodium intake was significantly reduced at the end of intervention, ( p  = 0.004). WhatsApp group was more efficient in the percentage of reduction of participants exceeding WHO recommendation compared with baseline, with  p  = 0.023. A significant reduction in the practice toward adding salt during cooking, use of table salt, adding salt before tasting the foods and use of chicken stocks for both intervention groups was noted with  p  < 0.05. Intervention groups showed a significant improvement ( p  < 0.001) in Food and Health related knowledge after 6-weeks of intervention.
Conclusion


The digital platform approach such as WhatsApp and Electronic Brochure were effective in salt reduction. This study proves that UAE population is ready to reduce salt intake with appropriate education materials and easy delivery approach.",2022,"Intervention groups showed a significant improvement ( p  < 0.001) in Food and Health related knowledge after 6-weeks of intervention.
",['121 participants completed the study and fulfilled the inclusion criteria with female to male ratio of (0.95:1.05'],"['digital platform approach', 'WhatsApp group, and Electronic Brochures group']","['Salt Intake', 'KAP questionnaire and physical activity', 'sodium intake', 'reduction in sodium']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",121.0,0.0403949,"Intervention groups showed a significant improvement ( p  < 0.001) in Food and Health related knowledge after 6-weeks of intervention.
","[{'ForeName': 'Amjad H', 'Initials': 'AH', 'LastName': 'Jarrar', 'Affiliation': 'Department of Nutrition and Health, College of Medicine and Health Sciences, United Arab Emirates University (UAEU), Al Ain, United Arab Emirates.'}, {'ForeName': 'Ayesha S', 'Initials': 'AS', 'LastName': 'Al Dhaheri', 'Affiliation': 'Department of Nutrition and Health, College of Medicine and Health Sciences, United Arab Emirates University (UAEU), Al Ain, United Arab Emirates.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lightowler', 'Affiliation': 'Oxford Brookes Center for Nutrition and Health, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, United Kingdom.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cheikh Ismail', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, Sharjah, United Arab Emirates.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Al-Meqbaali', 'Affiliation': 'Department of Nutrition and Health, College of Medicine and Health Sciences, United Arab Emirates University (UAEU), Al Ain, United Arab Emirates.'}, {'ForeName': ""Mo'ath F"", 'Initials': 'MF', 'LastName': 'Bataineh', 'Affiliation': 'Department of Nutrition and Health, College of Medicine and Health Sciences, United Arab Emirates University (UAEU), Al Ain, United Arab Emirates.'}, {'ForeName': 'Aseilah', 'Initials': 'A', 'LastName': 'Alhefeiti', 'Affiliation': 'Department of Nutrition and Health, College of Medicine and Health Sciences, United Arab Emirates University (UAEU), Al Ain, United Arab Emirates.'}, {'ForeName': 'Maithah', 'Initials': 'M', 'LastName': 'Albreiki', 'Affiliation': 'Department of Nutrition and Health, College of Medicine and Health Sciences, United Arab Emirates University (UAEU), Al Ain, United Arab Emirates.'}, {'ForeName': 'Nouf', 'Initials': 'N', 'LastName': 'Albadi', 'Affiliation': 'Department of Nutrition and Health, College of Medicine and Health Sciences, United Arab Emirates University (UAEU), Al Ain, United Arab Emirates.'}, {'ForeName': 'Salama', 'Initials': 'S', 'LastName': 'Alkaabi', 'Affiliation': 'Department of Nutrition and Health, College of Medicine and Health Sciences, United Arab Emirates University (UAEU), Al Ain, United Arab Emirates.'}, {'ForeName': 'Pariyarath S', 'Initials': 'PS', 'LastName': 'Thondre', 'Affiliation': 'Oxford Brookes Center for Nutrition and Health, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, United Kingdom.'}]",Frontiers in public health,['10.3389/fpubh.2022.860835']
1458,35685676,Effect of Preventive Analgesia with Nalbuphine and Dexmedetomidine in Endoscopic Sinus Surgery.,"Background


The study was to assess the efficacy and safety of nalbuphine combined with dexmedetomidine for preventive analgesia in endoscopic sinus surgery.
Methods


110 patients with deviation of the nasal septum were randomized into the nalbuphine group (group N), dexmedetomidine combined with nalbuphine group (group DN), and saline group (group C). Fifteen minutes before the induction of anesthesia, patients in group N were injected nalbuphine 0.2 mg/kg intravenously; patients in group DN received intravenous infusion of dexmedetomidine 0.5  μ g/kg and injection of nalbuphine 0.2 mg/kg; patients in group C received 0.9% saline. Mean arterial pressure (MAP), heart rate (HR), numerical rating scale (NRS) scores, quality of recovery-40 (QoR-40) scores, the need for remedial analgesia, the consumption of remifentanil and propofol, and the incidence of adverse reactions were recorded.
Results


MAP, HR, and NRS scores of the DN group were significantly lower and the QoR-40 scores were higher than those of groups N and C ( P  < 0.001). The need for remedial analgesia, the consumption of remifentanil and propofol, and the incidence of nausea in the DN group were the lowest among the three groups ( P  < 0.001).
Conclusion


Preventive analgesia with nalbuphine and dexmedetomidine in endoscopic sinus surgery can not only maintain hemodynamic stability but also reduce intraoperative anesthetic dosage, postoperative pain, and improve the quality of postoperative recovery without affecting the revival and extubation time.",2022,"Results


MAP, HR, and NRS scores of the DN group were significantly lower and the QoR-40 scores were higher than those of groups N and C ( P  < 0.001).","['Endoscopic Sinus Surgery', '110 patients with deviation of the nasal septum']","['intravenous infusion of dexmedetomidine 0.5\u2009 μ g/kg and injection of nalbuphine 0.2\u2009mg/kg; patients in group C received 0.9% saline', 'dexmedetomidine combined with nalbuphine group (group DN), and saline', 'nalbuphine', 'Nalbuphine and Dexmedetomidine', 'nalbuphine and dexmedetomidine', 'nalbuphine combined with dexmedetomidine']","['hemodynamic stability', 'intraoperative anesthetic dosage, postoperative pain', 'QoR-40 scores', 'efficacy and safety', 'incidence of nausea', 'Mean arterial pressure (MAP), heart rate (HR), numerical rating scale (NRS) scores, quality of recovery-40 (QoR-40) scores, the need for remedial analgesia, the consumption of remifentanil and propofol, and the incidence of adverse reactions', 'Results\n\n\nMAP, HR, and NRS scores']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0027432', 'cui_str': 'Nasal septum structure'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",110.0,0.208938,"Results


MAP, HR, and NRS scores of the DN group were significantly lower and the QoR-40 scores were higher than those of groups N and C ( P  < 0.001).","[{'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, Department of Pain, The Affiliated Huaian Hospital of Xuzhou Medical University, Huaian Second People's Hospital, Huaian, Jiangsu, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of General Surgery, The Affiliated Huaian Hospital of Xuzhou Medical University, Huaian Second People's Hospital, Huaian, Jiangsu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ""Department of Anesthesiology, Department of Pain, The Affiliated Huaian Hospital of Xuzhou Medical University, Huaian Second People's Hospital, Huaian, Jiangsu, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Department of Pain, The Affiliated Huaian Hospital of Xuzhou Medical University, Huaian Second People's Hospital, Huaian, Jiangsu, China.""}]",Pain research & management,['10.1155/2022/2344733']
1459,35685654,Computed Tomography Imaging under Artificial Intelligence Reconstruction Algorithm Used in Recovery of Sports Injury of the Knee Anterior Cruciate Ligament.,"This study aimed to analyze the influence of artificial intelligence (AI) reconstruction algorithm on computed tomography (CT) images and the application of CT image analysis in the recovery of knee anterior cruciate ligament (ACL) sports injuries. A total of 90 patients with knee trauma were selected for enhanced CT scanning and randomly divided into three groups. Group A used the filtered back projection (FBP) reconstruction algorithm, and the tube voltage was set to 120 kV during CT scanning. Group B used the iDose4 reconstruction algorithm, and the tube voltage was set to 120 kV during CT scanning. In group C, the iDose4 reconstruction algorithm was used, and the tube voltage was set to 100 kV during CT scanning. The noise, signal-to-noise ratio (SNR), carrier-to-noise ratio (CNR), CT dose index volume (CTDI), dose length product (DLP), and effective radiation dose (ED) of the three groups of CT images were compared. The results showed that the noise of groups B and C was smaller than that of group A ( P  < 0.05), and the SNR and CNR of groups B and C were higher than those of group A. The images of patients in group A with the FBP reconstruction algorithm were noisy, and the boundaries were not clear. The noise of the images obtained by the iDose4 reconstruction algorithm in groups B and C was improved, and the image resolution was also higher. The agreement between arthroscopy and CT scan results was 96%. Therefore, the iterative reconstruction algorithm of iDose4 can improve the image quality. It was of important value in the diagnosis of knee ACL sports injury.",2022,"The results showed that the noise of groups B and C was smaller than that of group A ( P  < 0.05), and the SNR and CNR of groups B and C were higher than those of group A.","['90 patients with knee trauma', 'knee anterior cruciate ligament (ACL) sports injuries', 'Sports Injury of the Knee Anterior Cruciate Ligament']","['filtered back projection (FBP) reconstruction algorithm', 'artificial intelligence (AI) reconstruction algorithm', 'enhanced CT scanning', 'Computed Tomography Imaging under Artificial Intelligence Reconstruction Algorithm']","['noise, signal-to-noise ratio (SNR), carrier-to-noise ratio (CNR), CT dose index volume (CTDI), dose length product (DLP), and effective radiation dose (ED']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0004161', 'cui_str': 'Sports injury'}]","[{'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",90.0,0.0169128,"The results showed that the noise of groups B and C was smaller than that of group A ( P  < 0.05), and the SNR and CNR of groups B and C were higher than those of group A.","[{'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'College of Mathematics and Statistics, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Haiming', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Military Logistics, Army Logistics Academy, Chongqing 401331, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Department of Military Logistics, Army Logistics Academy, Chongqing 401331, China.'}, {'ForeName': 'Kaiwen', 'Initials': 'K', 'LastName': 'Luo', 'Affiliation': 'Department of Military Logistics, Army Logistics Academy, Chongqing 401331, China.'}, {'ForeName': 'Shukai', 'Initials': 'S', 'LastName': 'Duan', 'Affiliation': 'College of Artificial Intelligence, Southwest University, Chongqing 400715, China.'}]",Contrast media & molecular imaging,['10.1155/2022/1199841']
1460,35686088,MindKind: A mixed-methods protocol for the feasibility of global digital mental health studies in young people.,"Background:  While an estimated 14-20% of young adults experience mental health conditions worldwide, the best strategies for prevention and management are not fully understood. The ubiquity of smartphone use among young people makes them excellent candidates for collecting data about lived experiences and their relationships to mental health. However, not much is known about the factors affecting young peoples' willingness to share information about their mental health.  Objective:  We aim to understand the data governance and engagement strategies influencing young peoples' (aged 16-24) participation in app-based studies of mental health. We hypothesize that willingness to participate in research is influenced by involvement  in how their data is collected, shared, and used.  Methods:  Here, we describe the MindKind Study, which employs mixed methods to understand the feasibility of global, smartphone-based studies of youth mental health. A pilot 12-week app-based substudy will query participants' willingness to engage with remote mental health studies. Participants will be randomized into one of four different data governance models designed to understand their preferences, as well as the acceptability of models that allow them more or less control over how their data are accessed and used. Enrolees will receive one of two different engagement strategies. A companion qualitative study will employ a deliberative democracy approach to examine the preferences, concerns and expectations of young people, with respect to remote mental health research. We also detail our engagement with young people as co-researchers in this study. This pilot study is being conducted in India, South Africa and the United Kingdom.  Conclusions:  This study is expected to generate new insights into the feasibility of, and best practices for, remote smartphone-based studies of mental health in youth and represents an important step toward understanding which approaches could help people better manage their mental health.",2021,A pilot 12-week app-based substudy will query participants' willingness to engage with remote mental health studies.,"[""young peoples' (aged 16-24) participation in app-based studies of mental health"", ""query participants' willingness to engage with remote mental health studies"", 'youth mental health', 'young people', 'India, South Africa and the United Kingdom']",[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]",[],[],,0.0478373,A pilot 12-week app-based substudy will query participants' willingness to engage with remote mental health studies.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Wellcome open research,['10.12688/wellcomeopenres.17167.2']
1461,35685986,"Effect of Single-Dose Preemptive Systemic Dexamethasone on Postoperative Dysphagia and Odynophagia Following Anterior Cervical Spine Surgery: A Double-Blinded, Prospective, Randomized Controlled Trial.","Background


The efficacy of preoperative dexamethasone in anterior cervical discectomy and fusion (ACDF) to reduce dysphagia and odynophagia remains controversial. This study evaluated the effect of a single dose of intravenous dexamethasone given as preemptive analgesia in the ACDF procedure.
Methods


A total of 64 patients aged 18 years or over were randomized into two groups. The experimental group received dexamethasone 10 mg intravenously before surgery for 60 minutes, and the control group received normal saline. One surgeon operated on all patients. The Bazaz score and visual analog scale (VAS) for odynophagia were measured at 0 hour, 24 hours, 48 hours, 72 hours, and 2 weeks postoperatively. Prevertebral soft-tissue swelling (PSTS) and the modified Japanese orthopedic association (mJOA) score were measured preoperatively and 2 weeks postoperatively.
Results


The Bazaz scores at 0, 24, 48, and 72 hours after operation were significantly lower in the dexamethasone group than in the placebo group ( p  < 0.001,  p  < 0.001,  p  < 0.001, and  p  = 0.004, respectively). The VAS scores of the dexamethasone group were significantly lower than those of the placebo group at 0, 24, 48, and 72 hours after surgery (all  p  < 0.001), but there was no significant reduction in the Bazaz score and VAS score at 2 weeks postoperatively. There was no difference in PSTS and mJOA preoperatively and 2 weeks postoperatively.
Conclusions


A single dose of intravenous dexamethasone used preoperatively in single-level and multilevel ACDF can significantly improve symptoms of dysphagia and odynophagia early on postoperatively.",2022,"The Bazaz scores at 0, 24, 48, and 72 hours after operation were significantly lower in the dexamethasone group than in the placebo group ( p  < 0.001,  p  < 0.001,  p  < 0.001, and  p  = 0.004, respectively).",['64 patients aged 18 years or over'],"['dexamethasone', 'preoperative dexamethasone', 'placebo', 'Single-Dose Preemptive Systemic Dexamethasone', 'control group received normal saline', 'Anterior Cervical Spine Surgery']","['Bazaz score and visual analog scale (VAS) for odynophagia', 'Postoperative Dysphagia and Odynophagia', 'Prevertebral soft-tissue swelling (PSTS) and the modified Japanese orthopedic association (mJOA) score', 'Bazaz scores', 'Bazaz score and VAS score', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0221150', 'cui_str': 'Swallowing painful'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0037580', 'cui_str': 'Soft tissue swelling'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",64.0,0.568085,"The Bazaz scores at 0, 24, 48, and 72 hours after operation were significantly lower in the dexamethasone group than in the placebo group ( p  < 0.001,  p  < 0.001,  p  < 0.001, and  p  = 0.004, respectively).","[{'ForeName': 'Koopong', 'Initials': 'K', 'LastName': 'Siribumrungwong', 'Affiliation': 'Department of Orthopaedics, Thammasat Hospital, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Patipan', 'Initials': 'P', 'LastName': 'Kanjanapirom', 'Affiliation': 'Department of Orthopaedics, Thammasat Hospital, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Naphakkhanith', 'Initials': 'N', 'LastName': 'Dhanachanvisith', 'Affiliation': 'Department of Orthopaedics, Thammasat Hospital, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Pattanapattana', 'Affiliation': 'Department of Orthopaedics, Thammasat Hospital, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.'}]",Clinics in orthopedic surgery,['10.4055/cios21139']
1462,35685982,"Clinical and Anatomical Outcomes of Arthroscopic Repair of Large Rotator Cuff Tears with Allograft Patch Augmentation: A Prospective, Single-Blinded, Randomized Controlled Trial with a Long-term Follow-up.","Background


Arthroscopic rotator cuff repair using human dermal matrix allograft augmentation has been widely used. We assessed the effect of acellular human dermal matrix augmentation after arthroscopic repair of large rotator cuff tears through a prospective, single-blinded, randomized controlled trial with a long-term follow-up.
Methods


Sixty patients with large-sized rotator cuff tears were randomly assigned to two groups. Patients in the control group underwent arthroscopic rotator cuff repair. Allograft patch augmentation was additionally performed in the allograft group. All patients were subdivided into a complete coverage (CC) group or an incomplete coverage (IC) group according to footprint coverage after cuff repair. Constant and American Shoulder and Elbow Surgeons (ASES) scores were assessed preoperatively and at final follow-up. Magnetic resonance imaging was also performed at the same time to evaluate the anatomical results.
Results


Forty-three patients were followed up for an average of 5.7 years. Clinical scores (Constant and ASES) increased significantly at the last follow-up in both groups. The increase in ASES score in the allograft group was statistically significantly greater than that in the control group. The degree of Constant score improvement did not differ significantly between the two groups. The retear rate was 9.1% in the allograft group, which was significantly lower than that in the control group (38.1%). In the control group, the CC subgroup had a statistically significantly lower retear rate (16.7%) than did the IC subgroup. There were no retear cases in the CC subgroup of the allograft group.
Conclusions


Long-term follow-up of arthroscopic repair of large rotator cuff tears with allograft patch augmentation showed better clinical and anatomical results. Footprint coverage after rotator cuff repair was an important factor affecting the retear rate. If the footprint was not completely covered after rotator cuff repair, allograft patch augmentation may reduce the retear rate.",2022,"The retear rate was 9.1% in the allograft group, which was significantly lower than that in the control group (38.1%).","['large rotator cuff tears', 'Sixty patients with large-sized rotator cuff tears']","['\n\n\nArthroscopic rotator cuff repair using human dermal matrix allograft augmentation', 'acellular human dermal matrix augmentation', 'incomplete coverage (IC) group according to footprint coverage after cuff repair', 'arthroscopic rotator cuff repair', 'Arthroscopic Repair of Large Rotator Cuff Tears with Allograft Patch Augmentation', 'Magnetic resonance imaging']","['degree of Constant score improvement', 'Clinical scores (Constant and ASES', 'Allograft patch augmentation', 'Constant and American Shoulder and Elbow Surgeons (ASES) scores', 'ASES score', 'retear rate']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",60.0,0.0544994,"The retear rate was 9.1% in the allograft group, which was significantly lower than that in the control group (38.1%).","[{'ForeName': 'Geun Woo', 'Initials': 'GW', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung Youn', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ho Won', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joon Hyeok', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Orthopaedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyu-Cheol', 'Initials': 'KC', 'LastName': 'Noh', 'Affiliation': 'Department of Orthopaedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}]",Clinics in orthopedic surgery,['10.4055/cios21135']
1463,35685899,Deep Learning-Based Surface Nerve Electromyography Data of E-Health Electroacupuncture in Treatment of Peripheral Facial Paralysis.,"This study was aimed at exploring the application value of electroacupuncture in the treatment of peripheral facial palsy using surface nerve electromyogram (EMG) image data based on deep learning. The surface nerve EMG recognition model was constructed based on multiview convolutional neural network, and the differences between it and the traditional single-view convolutional neural network were analyzed. Meanwhile, the influence of the multiview aggregation method based on pooling of view and decision fusion on facial recognition accuracy was compared and analyzed. 150 patients with peripheral facial paralysis were randomly divided into the control group ( n  = 70, basic treatment) and treatment group ( n  = 80, basic treatment + electroacupuncture). After 4 weeks of treatment, the therapeutic effect was evaluated by surface EMG parameters based on Horsfall-Barratt ( H - B ) scale and multiview convolutional neural network. The results showed that the face recognition accuracy of multiview convolutional neural networks was significantly higher than that of all single-view convolutional neural networks. The multiview aggregation network proposed in this research had a higher accuracy in facial recognition than the pooling of the view method and decision fusion-based multiview aggregation method. According to the evaluation results of H-B scale, the number of patients who recovered, significantly effective, effective, and ineffective in the control group was 39, 17, 3, and 11, respectively. The number of patients in the treatment group who recovered, significantly effective, effective, and ineffective was 51, 15, 9, and 5, respectively. Total effective rate of patients in the control group was 84.29%, and that of the treatment group was 93.75%, which was significantly higher than the control group ( P  < 0.05). According to surface EMG assessment results, compared with the control group, the mean root mean square (RMS), median frequency (MF), and mean power frequency (MPF) of the buccal and frontalis muscles in the treatment group increased significantly ( P  < 0.05). Compared with that before treatment, the mean buccal and frontalis RMS of patients in the control and treatment groups increased significantly after treatment ( P  < 0.05). In conclusion, electroacupuncture treatment could significantly improve the muscle strength of patients with peripheral facial paralysis.",2022,"Compared with that before treatment, the mean buccal and frontalis RMS of patients in the control and treatment groups increased significantly after treatment ( P  < 0.05).","['150 patients with peripheral facial paralysis', 'Peripheral Facial Paralysis', 'peripheral facial palsy', 'patients with peripheral facial paralysis']","['Deep Learning-Based Surface Nerve Electromyography Data of E-Health Electroacupuncture', 'control group ( n  = 70, basic treatment) and treatment group ( n  = 80, basic treatment + electroacupuncture', 'electroacupuncture']","['surface EMG parameters based on Horsfall-Barratt ( H - B ) scale and multiview convolutional neural network', 'muscle strength', 'effective, effective, and ineffective', 'mean buccal and frontalis RMS', 'facial recognition accuracy', 'face recognition accuracy of multiview convolutional neural networks', 'mean root mean square (RMS), median frequency (MF), and mean power frequency (MPF) of the buccal and frontalis muscles', 'Total effective rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751142', 'cui_str': 'Lower Motor Neuron Facial Palsy'}, {'cui': 'C3266178', 'cui_str': 'Peripheral facial palsy'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0871740', 'cui_str': 'Face Perception'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0224110', 'cui_str': 'Structure of frontal belly of occipitofrontalis muscle'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",150.0,0.0109895,"Compared with that before treatment, the mean buccal and frontalis RMS of patients in the control and treatment groups increased significantly after treatment ( P  < 0.05).","[{'ForeName': 'Pengdong', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': ""Department of Acupuncture and Rehabilitation Physiotherapy, Ningbo Fenghua People's Hospital Medical Community, Ningbo, 315500 Zhejiang, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Electromyography, Ningbo Fenghua People's Hospital Medical Community, Ningbo, 315500 Zhejiang, China.""}, {'ForeName': 'Lumin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Acupuncture and Rehabilitation Physiotherapy, Ningbo Fenghua People's Hospital Medical Community, Ningbo, 315500 Zhejiang, China.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Acupuncture and Rehabilitation Physiotherapy, Ningbo Fenghua People's Hospital Medical Community, Ningbo, 315500 Zhejiang, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/8436741']
1464,35686212,Hospital Cost Savings for Sequential COPD Patients Receiving Domiciliary Nasal High Flow Therapy.,"Purpose


To estimate the 5-year budget impact to Aotearoa New Zealand (NZ) hospitals of domiciliary nasal high flow (NHF) therapy to patients with chronic obstructive pulmonary disease (COPD) who require long term oxygen therapy.
Methods


Hospital admission counts along with length of stay were obtained from hospital records of 200 COPD patients enrolled in a 12-month randomized clinical trial of NHF in Denmark, both over a 12-month baseline and then in the study period while on randomized treatment (control or NHF). NZ costings from similar COPD patients were estimated using data from Middlemore Hospital, Auckland and were applied to the Danish trial. The budget impact of NHF was estimated over the predicted 5-year lifetime of the device when used by patients sequentially.
Results


Fifty-five of 100 patients in the NHF group and 44 of 100 patients in the control group were admitted to hospital with a respiratory diagnosis during the baseline year. They had 108 admissions in the treatment group vs 89 in the control group, with 632 vs 438 days in hospital, and modeled annual costs of $9443 vs $6512 per patient, respectively. During the study period there were 38 vs 44 patients with 67 vs 80 admissions and 302 vs 526 days in hospital, at a modeled annual cost of $6961 vs $9565 per patient respectively. Taking into account capital expenditure and running costs, this resulted in cost savings of $5535 per patient-year (95% CI, -$36 to -$11,034). With 90% usage over the estimated five-year lifetime of the NHF device, amortized capital costs of $594 per year and annual running costs of $662, we estimate a 5-year undiscounted cost saving per NHF device of $18,626 ($16,934 when discounted to net present value at 5% per annum). There would still be annual cost savings over a wide range of assumptions.
Conclusion


Domiciliary NHF therapy for patients with severe COPD has the potential to provide substantial hospital cost savings over the five-year lifetime of the NHF device.",2022,"They had 108 admissions in the treatment group vs 89 in the control group, with 632 vs 438 days in hospital, and modeled annual costs of $9443 vs $6512 per patient, respectively.","['Fifty-five of 100 patients in the NHF group and 44 of 100 patients in the control group were admitted to hospital with a respiratory diagnosis during the baseline year', '44 patients with 67 vs 80 admissions and 302 vs 526 days in hospital, at a modeled annual cost of $6961 vs $9565 per patient respectively', '200 COPD patients enrolled', 'Sequential COPD Patients', 'patients with chronic obstructive pulmonary disease (COPD) who require long term oxygen therapy', 'patients with severe COPD']","['Domiciliary NHF therapy', 'NHF', 'randomized treatment (control or NHF', 'Aotearoa New Zealand (NZ) hospitals of domiciliary nasal high flow (NHF) therapy', 'Domiciliary Nasal High Flow Therapy']","['cost savings', 'Hospital Cost Savings', '5-year undiscounted cost saving per NHF device']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}]","[{'cui': 'C0338047', 'cui_str': 'Domiciliary'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",200.0,0.143992,"They had 108 admissions in the treatment group vs 89 in the control group, with 632 vs 438 days in hospital, and modeled annual costs of $9443 vs $6512 per patient, respectively.","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Milne', 'Affiliation': 'Health Outcomes Associates Ltd, Auckland, New Zealand.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Hockey', 'Affiliation': 'Biometrics Matters Ltd, Hamilton, New Zealand.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Garrett', 'Affiliation': 'Middlemore Hospital, Auckland, New Zealand.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S350267']
1465,35675677,Safety and Efficacy of a Mobiderm Compression Bandage During Intensive Phase of Decongestive Therapy in Patients with Breast Cancer-Related Lymphedema: A Randomized Controlled Trial.,"Background:  Breast cancer-related lymphedema (BCRL) after primary therapy is a common condition, causing physical and psychological distress. Decongestive lymphedema therapy (DLT) using multi-layered compression bandages is an effective treatment. We conducted a randomized controlled trial evaluating the use of a specific mobilizing bandage (Mobiderm ® ) on lymphedema volume reduction during the intensive phase of DLT.  Methods and Results:  Fifty female BCRL patients were randomized to receive either conventional multi-layered bandages or mobilizing bandaging by using Mobiderm. Affected limb volume and excess volume were evaluated at baseline (D0) and after 15 days. The primary outcome was change in affected limb volume after adjustment for baseline. Symptom scores were evaluated by visual analogue scale (VAS); safety and tolerability were also assessed. Baseline characteristics were comparable. Affected limb volume reduction was observed in both study groups after 15 days: by 19.0% in the Mobiderm arm and 8.6% in controls (adjusted values). The between-group mean difference in adjusted volume reduction at day 15 was 256 mL (95% confidence interval [CI], 92.5 to 421.3 mL;  p  = 0.003) favoring Mobiderm. Reductions in excess volume of 57.3% (Mobiderm) and 25.1% (controls) were observed (adjusted values); with between-group mean difference in adjusted excess volume of 220.2 mL (95% CI, 69.3 to 371.3 mL;  p  = 0.006) favoring Mobiderm. Pain/heaviness VAS scores fell significantly in both groups, with mean reductions of 1.84 (Mobiderm) versus 0.83 (control;  p  = 0.001). Both regimens were well tolerated.  Conclusion:  The use of Mobiderm in multilayer compression bandaging shows benefit in lymphedema reduction and in alleviating functional symptoms/pain in patients with BRCL.",2022,"Pain/heaviness VAS scores fell significantly in both groups, with mean reductions of 1.84 (Mobiderm) versus 0.83 (control;  p  = 0.001).","['Patients with Breast Cancer-Related Lymphedema', 'patients with BRCL', 'Fifty female BCRL patients', 'Breast cancer-related lymphedema (BCRL']","['conventional multi-layered bandages or mobilizing bandaging by using Mobiderm', 'Decongestive Therapy', 'Mobiderm in multilayer compression bandaging', 'specific mobilizing bandage (Mobiderm ® ', 'Mobiderm Compression Bandage', 'Decongestive lymphedema therapy (DLT) using multi-layered compression bandages']","['adjusted volume reduction', 'Pain/heaviness VAS scores', 'tolerated', 'limb volume', 'Symptom scores', 'lymphedema volume reduction', 'limb volume reduction', 'visual analogue scale (VAS); safety and tolerability', 'limb volume and excess volume', 'Safety and Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1533146', 'cui_str': 'Compression bandaging'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0677875', 'cui_str': 'Compression Bandage'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0797894,"Pain/heaviness VAS scores fell significantly in both groups, with mean reductions of 1.84 (Mobiderm) versus 0.83 (control;  p  = 0.001).","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Dhar', 'Affiliation': 'Department of Surgical Disciplines and All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Department of Surgical Disciplines and All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Shrestha', 'Affiliation': 'THUASNE, Saint Etienne, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Villet', 'Affiliation': 'THUASNE, Saint Etienne, France.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Rekha Gogia', 'Affiliation': 'Amla Mediquip, New Delhi, India.'}]",Lymphatic research and biology,['10.1089/lrb.2021.0104']
1466,35676006,Randomised controlled trial comparing intraoperative cell salvage and autotransfusion with standard care in the treatment of hip fractures: a protocol for the WHITE 9 study.,"INTRODUCTION


People who sustain a hip fracture are typically elderly, frail and require urgent surgery. Hip fracture and the urgent surgery is associated with acute blood loss, compounding patients' pre-existing comorbidities including anaemia. Approximately 30% of patients require a donor blood transfusion in the perioperative period. Donor blood transfusions are associated with increased rates of infections, allergic reactions and longer lengths of stay. Furthermore, there is a substantial cost associated with the use of donor blood. Cell salvage and autotransfusion is a technique that recovers, washes and transfuses blood lost during surgery back to the patient. The objective of this study is to determine the clinical and cost effectiveness of intraoperative cell salvage, compared with standard care, in improving health related quality-of-life of patients undergoing hip fracture surgery.
METHODS AND ANALYSIS


Multicentre, parallel group, two-arm, randomised controlled trial. Patients aged 60 years and older with a hip fracture treated with surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either undergo cell salvage and autotransfusion or they will follow the standard care pathway. Otherwise, all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: EuroQol-5D-5L HRQoL at 4 months post injury. Secondary outcomes will include complications, postoperative delirium, residential status, mobility, allogenic blood use, mortality and resource use.
ETHICS AND DISSEMINATION


NHS ethical approval was provided on 14 August 2019 (19/WA/0197) and the trial registered (ISRCTN15945622). After the conclusion of this trial, a manuscript will be prepared for peer-review publication. Results will be disseminated in lay form to participants and the public.
TRIAL REGISTRATION NUMBER


ISRCTN15945622.",2022,"Donor blood transfusions are associated with increased rates of infections, allergic reactions and longer lengths of stay.","['1128 patients', 'hip fractures', 'People who sustain a hip fracture are typically elderly, frail and require urgent surgery', 'Patients aged 60 years and older with a hip fracture treated with surgery are eligible', 'patients undergoing hip fracture surgery']","['cell salvage and autotransfusion or they will follow the standard care pathway', 'intraoperative cell salvage and autotransfusion with standard care', 'Cell salvage and autotransfusion', 'intraoperative cell salvage']","['complications, postoperative delirium, residential status, mobility, allogenic blood use, mortality and resource use', 'rates of infections, allergic reactions and longer lengths of stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0005842', 'cui_str': 'Autotransfusion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.278613,"Donor blood transfusions are associated with increased rates of infections, allergic reactions and longer lengths of stay.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Dickenson', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Xavier Luke', 'Initials': 'XL', 'LastName': 'Griffin', 'Affiliation': 'Bone and Joint Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK x.griffin@qmul.ac.uk.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Mironov', 'Affiliation': 'Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': 'NHS Blood and Transplant, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wyse', 'Affiliation': 'Consultant Anaesthetist, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Appelbe', 'Affiliation': 'Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Athwal', 'Affiliation': 'Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Griffin', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2022-062338']
1467,35678177,"Hydrocortisone in the emergency department: a prospective, double-blind, randomized, controlled posttraumatic stress disorder study. Hydrocortisone during golden hours.","OBJECTIVES


A blunted response of the hypothalamic-pituitary-adrenal axis immediately after exposure to traumatic events has been proposed as a risk factor for posttraumatic stress disorder (PTSD). Accordingly, administration of hydrocortisone in the aftermath of a traumatic event is indicated. This study consisted of a randomized, placebo-controlled, double-blind trial investigating whether a single intravenous dose of hydrocortisone administered within 6 hours after exposure to trauma would reduce the incidence of PTSD at the 13-month follow-up.
METHODS


A total of 118 consented patients with acute stress symptoms were administered a single intravenous bolus of hydrocortisone/placebo within 6 hours of the traumatic event. Blood samples were taken before hydrocortisone administration.
RESULTS


At 13 months, the hydrocortisone group did not differ from the placebo group regarding PTSD prevalence or symptom severity. However, a significant interaction between time of the trauma (ie, night, when cortisol's level is low) and treatment was found. Specifically, a lower prevalence of PTSD was found at the 13-month follow-up in the hydrocortisone night group.
CONCLUSIONS


Administration of hydrocortisone within 6 hours of the traumatic event was not effective in preventing PTSD compared to placebo. However, nocturnal administration (when cortisol levels are low) may suggest a new venue for research.",2022,,[],['Hydrocortisone'],[],[],"[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",[],,0.728611,,"[{'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmi', 'Affiliation': 'Post Trauma Center, Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Zohar', 'Affiliation': 'Post Trauma Center, Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Weissman', 'Affiliation': 'Post Trauma Center, Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Alzbeta', 'Initials': 'A', 'LastName': 'Juven-Wetzler', 'Affiliation': 'The Psychiatry Department, Chaim Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bierer', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yehuda', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Hagit', 'Initials': 'H', 'LastName': 'Cohen', 'Affiliation': 'Anxiety and Stress Research Unit, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",CNS spectrums,['10.1017/S1092852922000852']
1468,35678134,The impact of mTOR inhibitors in the regression of left ventricular hypertrophy in elderly kidney transplant recipients.,"End-stage kidney disease is frequently associated with left ventricular hypertrophy (LVH), a condition more prevalent in the elderly, that may increase mortality after renal transplantation (RTx). Previous studies suggested that mTOR inhibitors (mTORi) can improve LVH, but this has never been tested in elderly kidney transplant recipients. In this prospective randomized clinical trial, we analyzed the impact of Everolimus (EVL) on the reversal of LVH after RTx in elderly recipients (≥60 years) submitted to different immunosuppressive regimens: EVL/lowTacrolimus (EVL group, n = 53) or mycophenolate sodium/regularTacrolimus (MPS group, n = 47). Patients performed echocardiograms (Echo) up to 3 months after RTx and then annually. At baseline, mean age was 65±3 years in both groups and LVH was observed in 63.6% of patients in EVL group and in 61.8% of MPS group. Last Echo was performed at mean time of 47 and 49 months after RTx in EVL and MPS groups, respectively (P = .34). LVH regression was observed in 23.8% (EVL group) and 19% (MPS group) of patients (P = 1.00). Mean eGFR, blood pressure, and use of RAS blockers were similar between groups throughout follow-up. EVL did not improve LVH in this cohort, and this lack of benefit may be attributed to concomitant use of TAC, senescence, or both.",2022,"Last Echo was performed at mean time of 47 and 49 months after RTx in EVL and MPS groups, respectively (p = 0.34).","['group, n = 47', 'elderly recipients (≥60y) submitted to different', 'elderly kidney transplant recipients']","['mTOR inhibitors', 'EVL', 'immunosuppressive regimens: EVL/lowTacrolimus (EVL group, n = 53) or mycophenolate sodium/regularTacrolimus (MPS', 'Everolimus (EVL', 'mTOR inhibitors (mTORi']","['Mean eGFR, blood pressure and use of RAS blockers', 'LVH regression']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1337395', 'cui_str': 'Mycophenolate sodium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}]",,0.0236426,"Last Echo was performed at mean time of 47 and 49 months after RTx in EVL and MPS groups, respectively (p = 0.34).","[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'David-Neto', 'Affiliation': 'Kidney Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Paes Menezes', 'Initials': 'MPM', 'LastName': 'Filho', 'Affiliation': 'Kidney Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Ítalo José Araújo Silveira', 'Initials': 'ÍJAS', 'LastName': 'de Sá', 'Affiliation': 'Kidney Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Agena', 'Affiliation': 'Kidney Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'José Lázaro', 'Initials': 'JL', 'LastName': 'de Andrade', 'Affiliation': 'Echochardiographic Service of the Image and Radiology Institute, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Flávio Jota', 'Initials': 'FJ', 'LastName': 'de Paula', 'Affiliation': 'Kidney Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.'}]",Clinical transplantation,['10.1111/ctr.14742']
1469,35679281,The SWIS trial: Protocol of a pragmatic cluster randomised controlled trial of school based social work.,"BACKGROUND


Child and family social workers in the UK work closely with other agencies including schools and the police, and typically they are based in local authority offices. This study will evaluate the effectiveness of placing social workers in schools (SWIS) on the need for social care interventions. SWIS was piloted in three local authorities in 2018-2020, and findings from a feasibility study of the pilots suggests SWIS may operate through three key pathways: (1) by enhancing schools' response to safeguarding issues, (2) through increased collaboration between social workers, school staff, and parents, and (3) by improving relationships between social workers and young people.
METHODS


The study is a two-arm pragmatic cluster randomised controlled trial building on three feasibility studies which found SWIS to be promising. Social workers will work within secondary schools across local authorities in England. 280 mainstream secondary schools will be randomly allocated with a 1:1 ratio to SWIS or a comparison arm, which will be schools that continue as normal, without a social worker. The primary outcome will be the rate of Child Protection (Section 47) enquiries. Secondary outcomes will comprise rate of referrals to children's social care, rate of Child in Need (Section 17) assessments, days spent in care, and educational attendance and attainment. The study also includes an economic evaluation, and an implementation and process evaluation. Social care outcomes will be measured in July 2022, and educational outcomes will be measured in July 2023. Days in care will be measured at both time points.
DISCUSSION


Findings will explore the effectiveness and cost-effectiveness of SWIS on the need for social care interventions. A final report will be published in January 2024.
TRIAL REGISTRATION


The study was registered retrospectively with the International Standard Randomised Controlled Trial Number registry on 13.11.2020 (ISRCTN90922032).",2022,This study will evaluate the effectiveness of placing social workers in schools (SWIS) on the need for social care interventions.,"['280 mainstream secondary schools', 'placing social workers in schools (SWIS', 'Child and family social workers']",[],"[""rate of referrals to children's social care, rate of Child in Need (Section 17) assessments, days spent in care, and educational attendance and attainment"", 'rate of Child Protection (Section 47) enquiries']","[{'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],"[{'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",,0.0974754,This study will evaluate the effectiveness of placing social workers in schools (SWIS) on the need for social care interventions.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Westlake', 'Affiliation': 'CASCADE, Cardiff University, Cardiff, Wales.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Pallmann', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, Wales.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lugg-Widger', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, Wales.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Forrester', 'Affiliation': 'CASCADE, Cardiff University, Cardiff, Wales.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Nuffield Department of primary care, University of Oxford, Oxford, England, United Kingdom.'}, {'ForeName': 'Shahd', 'Initials': 'S', 'LastName': 'Daher', 'Affiliation': 'Nuffield Department of primary care, University of Oxford, Oxford, England, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Adara', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, Wales.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'CASCADE, Cardiff University, Cardiff, Wales.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Munnery', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, Wales.'}, {'ForeName': 'Verity', 'Initials': 'V', 'LastName': 'Bennett', 'Affiliation': 'CASCADE, Cardiff University, Cardiff, Wales.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'CASCADE, Cardiff University, Cardiff, Wales.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, Wales.'}]",PloS one,['10.1371/journal.pone.0265354']
1470,35679254,Feasibility of a new multifactorial fall prevention assessment and personalized intervention among older people recently discharged from the emergency department.,"BACKGROUND AND IMPORTANCE


Falls among older people occur frequently and are a leading cause of Emergency department (ED) admissions, disability, death and rising health care costs. Multifactorial fall prevention programs that are aimed to target the population at risk have shown to effectively reduce the rate of falling and fall-related injuries in community-dwelling older people. However, the participation of and adherence to these programs in real life situation is generally low.
OBJECTIVE


To test the feasibility of a transitionally organized fall prevention assessment with accompanying personalized intervention initiated at the ED.
DESIGN, SETTINGS AND PARTICIPANTS


A process evaluation, of a non-randomized controlled pilot trial for implementing a transitionally organized multifactorial fall prevention intervention, was performed using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to gain insight into the barriers and facilitators of implementation. Older fallers (>70yrs) presenting at the ED were selected based on ZIP-code and after obtaining informed consent, data for the evaluation was collected through questionnaires and interviews. Furthermore, feedback was collected from the healthcare providers.
MAIN RESULTS


The consent was obtained by 24 (70%) of the patients approached directly at the ED and 17 (26%) of the patients approached later by phone. Adherence to the protocol by the participants, clinical assessors and family practice were all more than 90%. After three months, nine (26%) of the participants had at least one recurrent fall: three (20%) patients in the intervention group and six (32%) in the control group.
CONCLUSION


ED presentation due to a fall in older persons provides a window of opportunity for optimizing adherence to a multifactorial fall prevention program as willingness to participate was higher when the patients were approached at the ED during their stay. Implementing a transitionally organized multidisciplinary fall prevention program was successful with a high protocol adherence.
THE NETHERLANDS TRIAL REGISTER


NTR NL8142, November 8, 2019.",2022,The consent was obtained by 24 (70%) of the patients approached directly at the ED and 17 (26%) of the patients approached later by phone.,"['older persons', 'Older fallers (>70yrs) presenting at the ED', 'community-dwelling older people', 'older people recently discharged from the emergency department']","['transitionally organized fall prevention assessment with accompanying personalized intervention', 'new multifactorial fall prevention assessment and personalized intervention', 'transitionally organized multifactorial fall prevention intervention']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1300196', 'cui_str': 'Organized'}]",[],,0.023294,The consent was obtained by 24 (70%) of the patients approached directly at the ED and 17 (26%) of the patients approached later by phone.,"[{'ForeName': 'Bouke W', 'Initials': 'BW', 'LastName': 'Hepkema', 'Affiliation': 'Department of Rehabilitation VUmc, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Köster', 'Affiliation': 'Department of Rehabilitation VUmc, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Geleijn', 'Affiliation': 'Department of Rehabilitation VUmc, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'VAN DEN Ende', 'Affiliation': 'Department of Internal Medicine, Section General Internal Medicine Unit Acute Medicine, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Tahir', 'Affiliation': 'Department of Internal Medicine, Section General Internal Medicine Unit Acute Medicine, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Osté', 'Affiliation': 'Senior Policy Advisor Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Prins', 'Affiliation': 'General Practitioner Medical Center Gelderlandplein, Amsterdam, The Netherlands.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'VAN DER Velde', 'Affiliation': 'Department of Internal Medicine, Section of Geriatric Medicine, Amsterdam UMC Location AMC Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'VAN Hout', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Prabath W B', 'Initials': 'PWB', 'LastName': 'Nanayakkara', 'Affiliation': 'Department of Internal Medicine, Section General Internal Medicine Unit Acute Medicine, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0268682']
1471,35679691,"Effect of menthol/mint-flavored pods on young JUUL E-cigarette users' subjective experience, puffing behavior, and nicotine exposure: A pilot study.","BACKGROUND


Recent regulations have banned all flavors except menthol/mint and classic tobacco from pod-based e-cigarette devices such as JUUL. However, menthol/mint flavor can present a potential risk given its increasing popularity among young people in the US and its puffing and nicotine-enhancing properties. This study examines the impact of menthol/mint flavor manipulation on users' puffing behavior, subjective experience, and nicotine exposure among young people.
METHODS


JUUL users (n = 33, 18-24 years) attended two 60-min ad libitum e-cigarette use sessions (menthol/mint flavor vs. classic tobacco flavor) in a cross-over design. Puff topography and plasma nicotine concentration were measured, and participants completed subjective experience questionnaires.
RESULTS


Following the use of the menthol/mint-flavored pod, increases were observed in measures of satisfaction, pleasurable/interest to use, willingness to use again, enjoyment, urge to vape, product appeal, taste, and concentration (p < .05 for all). For example, compared to the classic tobacco flavor, participants experienced significantly more satisfaction of the product (4.24 vs. 3.09; p = .001) and sensation enjoyment of the product (3.55 vs. 2.48; p = .002) when using the menthol/mint flavor. While means of the plasma nicotine boost and puff parameters were lower in the classic tobacco condition compared to the menthol/mint flavor condition, no statistical significance was observed between the two conditions (p > .05 for all).
CONCLUSIONS


Results of this pilot study suggest that menthol/mint-flavor increases e-cigarette users' subjective experience significantly. Regulating menthol/mint flavor is a potentially promising strategy to curb e-cigarette use among young people.",2022,"While means of the plasma nicotine boost and puff parameters were lower in the classic tobacco condition compared to the menthol/mint flavor condition, no statistical significance was observed between the two conditions (p > .05 for all).
","['young people', 'JUUL users (n\xa0=\xa033, 18-24 years) attended two']","['Regulating menthol/mint flavor', '60-min ad libitum e-cigarette use sessions (menthol/mint flavor vs. classic tobacco flavor', 'menthol/mint flavor manipulation', 'menthol/mint-flavored pods', 'menthol/mint-flavor', 'menthol/mint flavor']","['plasma nicotine boost and puff parameters', 'measures of satisfaction, pleasurable/interest to use, willingness to use again, enjoyment, urge to vape, product appeal, taste, and concentration', 'sensation enjoyment', 'Puff topography and plasma nicotine concentration']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0452249', 'cui_str': 'Mint'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4083280', 'cui_str': 'Vape'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",33.0,0.0168828,"While means of the plasma nicotine boost and puff parameters were lower in the classic tobacco condition compared to the menthol/mint flavor condition, no statistical significance was observed between the two conditions (p > .05 for all).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Vargas-Rivera', 'Affiliation': 'Department of Community Outreach, Healthcare Network of Southwest Florida, FL, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Eissenberg', 'Affiliation': 'Center for the Study of Tobacco Products, Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Shihadeh', 'Affiliation': 'Center for the Study of Tobacco Products, Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA; Department of Mechanical Engineering, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Talih', 'Affiliation': 'Center for the Study of Tobacco Products, Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA; Department of Mechanical Engineering, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Maziak', 'Affiliation': 'Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, USA; Syrian Center for Tobacco Studies, Aleppo, Syrian Arab Republic. Electronic address: wmaziak@fiu.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109516']
1472,35680347,"Efficacy and safety of hydroxychloroquine in healthcare professionals with mild SARS-CoV-2 infection: Prospective, non-randomized trial.","OBJECTIVES


To assess the efficacy and safety of hydroxychloroquine (HCQ) compared with no treatment in healthcare workers with mild SARS-CoV-2 infection.
METHODS


Prospective, non-randomized study. All health professionals with confirmed COVID-19 between April 7 and May 6, 2020, non-requiring initial hospitalization were asked to participate. Patients who accepted treatment were given HCQ for five days (loading dose of 400mg q12h the first day followed by200mg q12h). Control group included patients with contraindications for HCQ or who rejected treatment. Study outcomes were negative conversion and viral dynamics of SARS-CoV-2, symptoms duration and disease progression.
RESULT


Overall, 142 patients were enrolled: 87 in treatment group and 55 in control group. The median age was 37 years and 75% were female, with few comorbidities. There were no significant differences in time to negative conversion of PCR between both groups. The only significant difference in the probability of negative conversion of PCR was observed at day 21 (18.7%, 95%CI 2.0-35.4). The decrease of SARS-CoV-2 viral load during follow-up was similar in both groups. A non significant reduction in duration of some symptoms in HCQ group was observed. Two patients with HCQ and 4 without treatment developed pneumonia. No patients required admission to the Intensive Care Unit or died. About 50% of patients presented mild side effects of HCQ, mainly diarrhea.
CONCLUSIONS


Our study failed to show a substantial benefit of HCQ in viral dynamics and in resolution of clinical symptoms in health care workers with mild COVID-19.",2022,Our study failed to show a substantial benefit of HCQ in viral dynamics and in resolution of clinical symptoms in health care workers with mild COVID-19.,"['Control group included patients with contraindications for HCQ or who rejected treatment', '142 patients were enrolled: 87 in treatment group and 55 in control group', 'healthcare professionals with mild SARS-CoV-2 infection', 'healthcare workers with mild SARS-CoV-2 infection', 'The median age was 37 years and 75% were female, with few comorbidities', 'health care workers with mild COVID-19']","['hydroxychloroquine', 'HCQ', 'hydroxychloroquine (HCQ']","['SARS-CoV-2 viral load', 'duration of some symptoms', 'time to negative conversion of PCR', 'mild side effects of HCQ, mainly diarrhea', 'pneumonia', 'efficacy and safety', 'Efficacy and safety', 'negative conversion and viral dynamics of SARS-CoV-2, symptoms duration and disease progression', 'probability of negative conversion of PCR']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C4319517', 'cui_str': 'Order rejected'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",142.0,0.0348417,Our study failed to show a substantial benefit of HCQ in viral dynamics and in resolution of clinical symptoms in health care workers with mild COVID-19.,"[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Agusti', 'Affiliation': ""Clinical Pharmacology Service, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Farmacologia, Terapèutica I Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Guillen', 'Affiliation': ""Clinical Pharmacology Service, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Farmacologia, Terapèutica I Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Ayora', 'Affiliation': ""Occupational Health Service, Vall d'Hebron Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Anton', 'Affiliation': ""Respiratory Viruses Unit, Microbiology Department, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Genètica i de Microbiologia, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Aguilera', 'Affiliation': ""Clinical Pharmacology Service, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Farmacologia, Terapèutica I Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vidal', 'Affiliation': ""Clinical Pharmacology Service, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Farmacologia, Terapèutica I Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andres', 'Affiliation': ""Respiratory Viruses Unit, Microbiology Department, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Genètica i de Microbiologia, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Alonso', 'Affiliation': ""Occupational Health Service, Vall d'Hebron Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Espuga', 'Affiliation': ""Occupational Health Service, Vall d'Hebron Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Esperalba', 'Affiliation': ""Respiratory Viruses Unit, Microbiology Department, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Genètica i de Microbiologia, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Mª Queralt', 'Initials': 'MQ', 'LastName': 'Gorgas', 'Affiliation': ""Departament de Farmacologia, Terapèutica I Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain; Clinical Pharmacy Service, Vall d'Hebron Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Benito', 'Initials': 'B', 'LastName': 'Almirante', 'Affiliation': ""Infectious Diseases Department, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Ribera', 'Affiliation': ""Infectious Diseases Department, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Electronic address: eriberap@gmail.com.""}]",Enfermedades infecciosas y microbiologia clinica (English ed.),['10.1016/j.eimce.2020.10.015']
1473,35680270,Improving community-based first response to out of hospital cardiac arrest (FirstCPR): protocol for a cluster randomised controlled trial.,"INTRODUCTION


Out-of-hospital cardiac arrest (OHCA) is associated with poor survival outcomes, but prompt bystander action can more than double survival rates. Being trained, confident and willing-to-perform cardiopulmonary resuscitation (CPR) are known predictors of bystander action. This study aims to assess the effectiveness of a community organisation targeted multicomponent education and training initiative on being willing to respond to OHCAs. The study employs a novel approach to reaching community members via social and cultural groups, and the intervention aims to address commonly cited barriers to training including lack of availability, time and costs.
METHODS AND ANALYSIS


FirstCPR is a cluster randomised trial that will be conducted across 200 community groups in urban and regional Australia. It will target community groups where CPR training is not usual. Community groups (clusters) will be stratified by region, size and organisation type, and then randomly assigned to either immediately receive the intervention programme, comprising digital and in-person education and training opportunities about CPR and OHCA over 12 months, or a delayed programme implementation. The primary outcome is self-reported 'training and willingness-to-perform CPR' at 12 months. It will be assessed through surveys of group members that consent in intervention versus control groups and administered prior to control groups receiving the intervention. The primary analysis will follow intention-to-treat principles, use log binomial regression accounting for baseline covariates and be conducted at the individual level, while accounting for clustering within communities. Focus groups and interviews will be conducted to examine barriers and enablers to implementation and costs will also be examined.
ETHICS AND DISSEMINATION


Ethical approval was obtained from The University of Sydney. Findings from this study will be disseminated via presentations at scientific conferences, publications in peer-reviewed journals, scientific and lay reports.
TRIAL REGISTRATION NUMBER


ACTRN12621000367842.",2022,"Being trained, confident and willing-to-perform cardiopulmonary resuscitation (CPR) are known predictors of bystander action.",['200 community groups in urban and regional Australia'],"['community organisation targeted multicomponent education and training initiative', 'intervention programme, comprising digital and in-person education and training opportunities about CPR and OHCA over 12\u2009months, or a delayed programme implementation']","[""self-reported 'training and willingness-to-perform CPR""]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",,0.0780188,"Being trained, confident and willing-to-perform cardiopulmonary resuscitation (CPR) are known predictors of bystander action.","[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Munot', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Bray', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Angell', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Newtown, New South Wales, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Coggins', 'Affiliation': 'Department of Emergency Medicine, Westmead Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alan Robert', 'Initials': 'AR', 'LastName': 'Denniss', 'Affiliation': 'Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Cate', 'Initials': 'C', 'LastName': 'Ferry', 'Affiliation': 'NSW Division, Heart Foundation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Jennings', 'Affiliation': 'Sydney Health Partners, Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Pramesh', 'Initials': 'P', 'LastName': 'Kovoor', 'Affiliation': 'Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Lai', 'Affiliation': 'Department of Emergency Medicine, Westmead Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Khanlari', 'Affiliation': 'Centre for Epidemiology and Evidence, NSW Ministry of Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Marschner', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Middleton', 'Affiliation': 'Emergency Department, Ingham Institute, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Centre for Epidemiology and Evidence, NSW Ministry of Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Opperman', 'Affiliation': 'NSW Data Analytics Centre, NSW Government, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Semsarian', 'Affiliation': 'Agnes Ginges Centre for Molecular Cardiology, Centenary Institute, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'Centre for Epidemiology and Evidence, NSW Ministry of Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Vukasovic', 'Affiliation': 'Department of Emergency Medicine, Westmead Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ware', 'Affiliation': 'Ambulance Service of NSW, Rozelle, New South Wales, Australia.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia clara.chow@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2021-057175']
1474,35680268,Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol.,"INTRODUCTION


New Interventions for independence in Dementia Study (NIDUS)-Family is an Alzheimer's Society funded new manualised, multimodal psychosocial intervention to support people living with dementia (PLWD) to achieve goals that they and their family carers set, towards living as independently and as well as possible at home for longer. This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment. The evaluation will test, refine and develop the NIDUS-Family theoretical model, associated causal assumptions and logic model to identify key mechanisms of impact, implementation and contextual factors influencing the intervention's effectiveness. Findings will inform how the programme is implemented in practice.
METHODS AND ANALYSIS


The process evaluation will be theory driven and apply a convergent mixed-methods design. Dyads (PLWD and family carer) will be purposively sampled based on high or low Goal Attainment Scaling scores (trial primary outcome). Qualitative interviews with dyads (approx. n=30) and their respective facilitators post-trial will explore their experiences of receiving and delivering the intervention. Interviews will be iteratively thematically analysed. Matching observational quantitative data will be collected concurrently from videorecordings and/or audiorecordings of NIDUS-Family dyad trial sessions. Further quantitative data will be collected through an acceptability questionnaire for all intervention-arm dyads (n=199). Mixed-method integration will use an interactive analysis strategy, considering qualitative and quantitative findings through mixed-method matrix for dyadic level 'case studies', and a joint display for 'population' level analysis and interpretation.
ETHICS AND DISSEMINATION


Ethical approval was received from Camden & Kings Cross Research Ethics Committee (REC). Study reference: 19/LO/1667. IRAS project ID: 271 363. This work is carried out within the UCL Alzheimer's Society Centre of Excellence (grant 300) for Independence at home, NIDUS programme.Findings will be disseminated through publications and conferences, and as recommendations for the implementation study and strategy.
TRIAL REGISTRATION NUMBER


ISRCTN11425138.",2022,"This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment.",['Dementia Study (NIDUS'],[],[],"[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],,0.147151,"This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment.","[{'ForeName': 'Danielle Laura', 'Initials': 'DL', 'LastName': 'Wyman', 'Affiliation': 'Faculty of Science and Engineering, Anglia Ruskin University - Cambridge Campus, Cambridge, UK dlw136@pgr.aru.ac.uk.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Butler', 'Affiliation': 'Psychology, Anglia Ruskin University - Cambridge Campus, Cambridge, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Psychiatry of Older Age, University College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bright', 'Affiliation': 'Psychology, Anglia Ruskin University - Cambridge Campus, Cambridge, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan-Trimmer', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Barber', 'Affiliation': 'Statistical Science, UCL, London, UK.'}]",BMJ open,['10.1136/bmjopen-2021-054613']
1475,35680173,"Efficacy and safety of the combined metabolic medication, containing inosine, nicotinamide, riboflavin and succinic acid, for the treatment of diabetic neuropathy: a multicenter randomized, double-blind, placebo-controlled parallel group clinical trial (CYLINDER).","INTRODUCTION


Antioxidants may have positive impact on diabetic polyneuropathy (DPN), presumably due to alleviation of oxidative stress. We aimed to evaluate the efficacy and safety of combination of antioxidants: succinic acid, inosine, nicotinamide, and riboflavin (SINR) in the treatment of DPN.
RESEARCH DESIGN AND METHODS


In a double-blind, placebo-controlled clinical trial, men and women aged 45-74 years with type 2 diabetes and symptomatic DPN, with initial Total Symptom Score (TSS) ˃5, were randomized into experimental (n=109) or placebo (n=107) group. Patients received study medication/placebo intravenously for 10 days, followed by oral administration for 75 days. Statistical significance was defined as a two-tailed p<0.05.
RESULTS


In SINR group, mean TSS change after 12 weeks was -2.65 (±1.46) vs -1.73 (±1.51) in the placebo group (p<0.0001; t-test). Reduction of symptoms in the SINR group was achieved regardless of hemoglobin A1c levels, but better results were observed in patients with initial TSS <7.5. The analysis of TSS subscores revealed statistically significant between-group differences by dynamics of the intensity of paresthesia and of numbness starting from day 11 (p=0.035 and p=0.001, respectively; mixed model); by day 57, statistically significant between-group differences were detected also by dynamics of burning intensity (p=0.005; mixed model). Study limitations are small effect size, moderate proportion of patients with severe DPN symptoms, subjective assessment of outcomes, exclusion of participants who received injectable glucose-lowering medications other than insulins, and patients with uncontrolled and type 1 diabetes.
CONCLUSIONS


The combination of SINR effectively alleviates DPN symptoms in patients with type 2 diabetes.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04649203; Unique Protocol ID: CTF-III-DM-2019).",2022,"Reduction of symptoms in the SINR group was achieved regardless of hemoglobin A1c levels, but better results were observed in patients with initial TSS <7.5.","['men and women aged 45-74 years with type 2 diabetes and symptomatic DPN, with initial Total Symptom Score (TSS) ˃5', 'patients with type 2 diabetes', 'patients with severe DPN symptoms, subjective assessment of outcomes, exclusion of participants who received injectable glucose-lowering medications other than insulins, and patients with uncontrolled and type 1 diabetes', 'diabetic neuropathy']","['antioxidants: succinic acid, inosine, nicotinamide, and riboflavin (SINR', 'SINR', 'placebo', 'combined metabolic medication, containing inosine, nicotinamide, riboflavin and succinic acid']","['intensity of paresthesia and of numbness starting', 'Efficacy and safety', 'mean TSS change', 'dynamics of burning intensity', 'Reduction of symptoms', 'DPN symptoms', 'hemoglobin A1c levels', 'TSS subscores']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0075429', 'cui_str': 'Succinic Acid'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}]",,0.606305,"Reduction of symptoms in the SINR group was achieved regardless of hemoglobin A1c levels, but better results were observed in patients with initial TSS <7.5.","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Kharitonova', 'Affiliation': ""Department of Acute Cerebrovascular Pathology and Emergency Neurology, Sankt-Peterburgskij naucno-issledovatel'skij institut skoroj pomosi imeni I I Dzanelidze, Sankt Peterburg, Russian Federation tvh2001@mail.ru.""}, {'ForeName': 'Yury G', 'Initials': 'YG', 'LastName': 'Shvarts', 'Affiliation': 'Department of Faculty Therapy, City Clinical Hospital, Saratov, Russian Federation.'}, {'ForeName': 'Andrey F', 'Initials': 'AF', 'LastName': 'Verbovoy', 'Affiliation': ""Department of Endocrinilogy, Limited Liability Company 'Center Diabetes', Samara, Russian Federation.""}, {'ForeName': 'Natalia S', 'Initials': 'NS', 'LastName': 'Orlova', 'Affiliation': ""Endocrinologist, 'Eco-Safety' Medical Center, St Petersburg, Russian Federation.""}, {'ForeName': 'Valentina P', 'Initials': 'VP', 'LastName': 'Puzyreva', 'Affiliation': 'City Endocrinology Center, City Hospital No 4, Rostov-on-Don, Russian Federation.'}, {'ForeName': 'Igor A', 'Initials': 'IA', 'LastName': 'Strokov', 'Affiliation': 'Department of Nervous Diseases and Neurosurgery, Sechenov University, Moskva, Russian Federation.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2022-002785']
1476,35680626,[Efficacy and safety of IAC regimen for relapse/refractory acute myeloid leukemia: a prospective randomized controlled study].,"Objective:  To evaluate the efficacy and toxicity profiles of idarubicin, cytarabine, and cyclophosphamide (IAC) in relapse/refractory acute myeloid leukemia (AML) .  Methods:  This study was a prospective, randomized controlled clinical trial with the registration number NCT02937662. The patients were randomly divided into two groups. The experimental group was treated with an IAC regimen, and the regimen of the control group was selected by doctors according to medication experience. After salvage chemotherapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) was conducted as far as possible according to the situation of the patients. We aimed to observe the efficacy, safety, and toxicity of the IAC regimen in relapse/refractory AML and to explore which is the better regimen.  Results:  Forty-two patients were enrolled in the clinical trial, with a median age of 36 years (IAC group, 22 cases and control groups, 20 cases) . ①The objective response rate was 71.4% in the IAC group and 40.0% in the control group ( P =0.062) ; the complete remission (CR) rate was 66.7% in the IAC group and 40.0% in the control group ( P =0.121) . The median follow-up time of surviving patients was 10.5 (range:1.7-32.8) months; the median overall survival (OS) was 14.1 (range: 0.6-49.1) months in the IAC group and 9.9 (range: 2.0-53.8) months in the control group ( P =0.305) . The 1-year OS was 54.5% (95% CI  33.7%-75.3%) in the IAC group and 48.2% (95% CI  25.9%-70.5%) in the control group ( P =0.305) , with no significant difference between these two regimens. ②The main hematologic adverse events (AEs) were anemia, thrombocytopenia, and neutropenia. The incidence of grade 3-4 hematologic AEs in the two groups was 100% (22/22) in the IAC group and 95% (19/20) in the control group. The median time of neutropenia after chemotherapy in the IAC group and control group was 20 (IQR: 8-30) and 14 (IQR: 5-50) days, respectively ( P =0.023) . ③The CR rate of the early relapse (relapse within 12 months) group was 46.7% and that of the late relapse (relapse after 12 months) group was 72.7% ( P =0.17) . The median OS time of early recurrence was 9.9 (range:1.7-53.8) months, and that of late recurrence patients was 19.3 (range: 0.6-40.8) months ( P =0.420) , with no significant differences between the two groups. The 1-year OS rates were 45.3% (95% CI  27.2%-63.3%) and 66.7% (95% CI  40.0%-93.4%) , respectively ( P =0.420) . Survival analysis showed that the 1-year OS rates of the hematopoietic stem cell transplantation group and non-hematopoietic stem cell transplantation group were 87.5% (95% CI  71.2%-100%) and 6.3% (95% CI  5.7%-18.3%) , respectively. The OS rate of the hematopoietic stem cell transplantation group was significantly higher than that of the non-hematopoietic stem cell transplantation group ( P <0.001) .  Conclusion:  The IAC regimen is a well-tolerated and effective regimen in relapsed/refractory AML; this regimen had similar efficacy and safety with the regimen selected according to the doctor's experience for treating relapsed/refractory AML. For relapsed/refractory patients with AML, allogeneic hematopoietic stem cell transplantation should be attempted as soon as possible to achieve long-term survival.",2022,The OS rate of the hematopoietic stem cell transplantation group was significantly higher than that of the non-hematopoietic stem cell transplantation group ( P <0.001) .  ,"['For relapsed/refractory patients with AML, allogeneic hematopoietic stem cell transplantation', 'relapse/refractory acute myeloid leukemia (AML) ', 'Forty-two patients were enrolled in the clinical trial, with a median age of 36 years (IAC group, 22 cases and control groups, 20 cases) ', 'relapse/refractory acute myeloid leukemia']","['IAC regimen', 'idarubicin, cytarabine, and cyclophosphamide (IAC', 'IAC', 'salvage chemotherapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT']","['objective response rate', '1-year OS', 'median OS time of early recurrence', 'OS rate', 'complete remission (CR) rate', 'efficacy and toxicity profiles', 'CR rate of the early relapse (relapse', 'incidence of grade 3-4 hematologic AEs', 'median overall survival (OS', 'hematologic adverse events (AEs) were anemia, thrombocytopenia, and neutropenia', 'efficacy, safety, and toxicity', 'median time of neutropenia', '1-year OS rates']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C4528668', 'cui_str': 'Acute myeloid leukaemia refractory'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",42.0,0.108625,The OS rate of the hematopoietic stem cell transplantation group was significantly higher than that of the non-hematopoietic stem cell transplantation group ( P <0.001) .  ,"[{'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Wei', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Qiu', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Gong', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Gong', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'Q Y', 'Initials': 'QY', 'LastName': 'Fang', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Zhang', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'K Q', 'Initials': 'KQ', 'LastName': 'Liu', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Zhou', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Liu', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Mi', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}, {'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Wang', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center for Blood Diseases, Tianjin 300020, China.'}]",Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi,['10.3760/cma.j.issn.0253-2727.2022.04.004']
1477,35681233,Paclitaxel and cisplatin combined with concurrent involved-field irradiation in definitive chemoradiotherapy for locally advanced esophageal squamous cell carcinoma: a phase II clinical trial.,"PURPOSE


This trial aims to explore the efficacy and safety of involved-field irradiation (IFI) combined with paclitaxel plus cisplatin as concurrent chemoradiotherapy for locally advanced esophageal squamous cell carcinoma (ESCC), under the premise of intensity-modulated radiotherapy (IMRT).
METHODS


Enrolled patients with locally advanced ESCC were treated with definitive concurrent chemoradiotherapy. IFI was administered adopting IMRT and the total dose was 61.2 Gy delivered in 34 fractions. On the first day of radiotherapy, the patients were treated with paclitaxel and cisplatin one cycle per month for 2 cycles followed by the same regimen in consolidation chemotherapy for two cycles. The primary endpoint of the study was the 2-year locoregional recurrence-free survival (LRFS) rate, and secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety.
RESULTS


Between January 2018 and September 2020, 108 patients participated in the trial. 78.7% (85/108) of patients completed all 4 cycles of chemotherapy. The median follow-up of the surviving patients was 33.9 months (interquartile range, 29.2-41.1). The 2-year LRFS rate, as the primary endpoint, was 64.2%. In addition, the median PFS was 39.2 months, and 1-year and 3-year OS rates of 88.0% and 63.3%, respectively. Among the patients, out-of-field regional failure was seen in only 7 (6.5%) patients. Neutropenia grade 3 and 4 occurred in 21.3% and 37.0% of the patients, respectively.
CONCLUSIONS


IFI using IMRT combined with paclitaxel and cisplatin concurrent chemotherapy for locally advanced ESCC yields encouraging local control and overall survival, but high hematological toxicity. Trial registration Clinical Trials ChiCTR1800017039.",2022,"The primary endpoint of the study was the 2-year locoregional recurrence-free survival (LRFS) rate, and secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety.
","['Between January 2018 and September 2020, 108 patients participated in the trial', 'locally advanced esophageal squamous cell carcinoma', 'locally advanced esophageal squamous cell carcinoma (ESCC', 'Enrolled patients with locally advanced ESCC']","['field irradiation (IFI) combined with paclitaxel plus cisplatin', 'IMRT combined with paclitaxel and cisplatin concurrent chemotherapy', 'radiotherapy', 'Paclitaxel and cisplatin combined with concurrent involved-field irradiation', 'paclitaxel and cisplatin', 'definitive concurrent chemoradiotherapy']","['efficacy and safety', '2-year LRFS rate', 'local control and overall survival', '2-year locoregional recurrence-free survival (LRFS) rate', '1-year and 3-year OS rates', 'median PFS', 'overall survival (OS), progression-free survival (PFS), and safety', 'Neutropenia grade']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}]","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",108.0,0.153856,"The primary endpoint of the study was the 2-year locoregional recurrence-free survival (LRFS) rate, and secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety.
","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Oncology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Dayong', 'Initials': 'D', 'LastName': 'Gu', 'Affiliation': 'Department of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Du', 'Affiliation': 'Department of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Radiology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Guoren', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Jinjun', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research, No. 42, Baiziting, Nanjing, 210009, China. jjye2004@163.com.'}]","Radiation oncology (London, England)",['10.1186/s13014-022-02078-3']
1478,35681224,Effectiveness of the MULTIPAP Plus intervention in youngest-old patients with multimorbidity and polypharmacy aimed at improving prescribing practices in primary care: study protocol of a cluster randomized trial.,"BACKGROUND


The progressive ageing of the population is leading to an increase in multimorbidity and polypharmacy, which in turn may increase the risk of hospitalization and mortality. The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process.
OBJECTIVE


To assess the effectiveness and cost-effectiveness of the complex intervention MULTIPAP Plus, compared to usual care, in improving prescriptions for young-old patients (65-74 years old) with multimorbidity and polypharmacy in primary care.
METHODS/DESIGN


This is a pragmatic cluster-randomized clinical trial with a follow-up of 18 months in health centres of the Spanish National Health System. Unit of randomization: family physician. Unit of analysis: patient.
POPULATION


Patients aged 65-74 years with multimorbidity (≥ 3 chronic diseases) and polypharmacy (≥ 5 drugs) during the previous 3 months were included.
SAMPLE SIZE


n = 1148 patients (574 per study arm).
INTERVENTION


Complex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system.
OUTCOMES


The primary outcome is a composite endpoint of hospital admission or death during the observation period measured as a binary outcome, and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment. Clinical and sociodemographic factors will be explanatory variables.
STATISTICAL ANALYSIS


The main result is the difference in percentages in the final composite endpoint variable at 18 months, with its corresponding 95% CI. Adjustments by the main confounding and prognostic factors will be performed through a multilevel analysis. All analyses will be carried out in accordance to the intention-to-treat principle.
DISCUSSION


It is important to prevent the cascade of negative health and health care impacts attributable to the multimorbidity-polypharmacy binomial. ICT-enhanced routine clinical practice could improve the prescription process in patient care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04147130 . Registered on 22 October 2019.",2022,"The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process.
","['young-old patients (65-74\u2009years old) with multimorbidity and polypharmacy in primary care', 'SAMPLE SIZE\n\n\nn = 1148 patients (574 per study arm', '18\u2009months in health centres of the Spanish National Health System', 'Patients aged 65-74\u2009years with multimorbidity (≥\u20093 chronic diseases) and polypharmacy (≥\u20095 drugs) during the previous 3\u2009months were included', 'youngest-old patients with multimorbidity and polypharmacy aimed at improving prescribing practices in primary care']","['ICT', 'care with information and communications technology (ICT', 'Complex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system', 'MULTIPAP Plus intervention', 'complex intervention MULTIPAP Plus']","['composite endpoint of hospital admission or death during the observation period measured as a binary outcome, and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment', 'effectiveness and cost-effectiveness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0150185', 'cui_str': 'Decision making encouragement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.213212,"The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process.
","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Del Cura-González', 'Affiliation': 'Research Unit, Primary Care Assistance Management, Madrid Health Service, Madrid, Spain. Isabel.cura@salud.madrid.org.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'López-Rodríguez', 'Affiliation': 'Research Unit, Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Gimeno-Feliu', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Pico-Soler', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Mª Josefa', 'Initials': 'MJ', 'LastName': 'Bujalance-Zafra', 'Affiliation': 'Multiprofessional Family and Community Care Teaching Unit of the Málaga-Guadalhorce Health District, Málaga, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Domínguez-Santaella', 'Affiliation': 'Multiprofessional Family and Community Care Teaching Unit of the Málaga-Guadalhorce Health District, Málaga, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Polentinos-Castro', 'Affiliation': 'Research Unit, Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Poblador-Plou', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ara-Bardají', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Aza-Pascual-Salcedo', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Rogero-Blanco', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Castillo-Jiménez', 'Affiliation': 'Multiprofessional Family and Community Care Teaching Unit of the Málaga-Guadalhorce Health District, Málaga, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lozano-Hernández', 'Affiliation': 'Research Unit, Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gimeno-Miguel', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'González-Rubio', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Medina-García', 'Affiliation': 'Research Unit, Primary Care Assistance Management, Madrid Health Service, Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'González-Hevilla', 'Affiliation': 'Multiprofessional Family and Community Care Teaching Unit of the Málaga-Guadalhorce Health District, Málaga, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gil-Conesa', 'Affiliation': 'Preventive Medicine Service, University Hospital Alcorcon Foundation, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Martín-Fernández', 'Affiliation': 'Department of Medical Specialties and Public Health, School of Health Sciences, Rey Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Valderas', 'Affiliation': 'Department of Family Medicine, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Marengoni', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Department of General Practice and Family Medicine, Medical Faculty OWL, University of Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'J Daniel', 'Initials': 'JD', 'LastName': 'Prados-Torres', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prados-Torres', 'Affiliation': 'Research Network on Health Services in Chronic Diseases REDISSEC-ISCIII, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-022-06293-x']
1479,35681220,"Early versus delayed enteral nutrition in mechanically ventilated patients with circulatory shock: a nested cohort analysis of an international multicenter, pragmatic clinical trial.","INTRODUCTION


Real-world evidence on the timing and efficacy of enteral nutrition (EN) practices in intensive care unit (ICU) patients with circulatory shock is limited. We hypothesized early EN (EEN), as compared to delayed EN (DEN), is associated with improved clinical outcomes in mechanically ventilated (MV) patients with circulatory shock.
METHODS


We analyzed a dataset from an international, multicenter, pragmatic randomized clinical trial (RCT) evaluating protein dose in ICU patients. Data were collected from ICU admission, and EEN was defined as initiating < 48 h from ICU admission and DEN > 48 h. We identified MV patients in circulatory shock to evaluate the association between the timing of EN initiation and clinical outcomes. The regression analysis model controlled for age, mNUTRIC score, APACHE II score, sepsis, and Site.
RESULTS


We included 626 patients, from 52 ICUs in 14 countries. Median age was 60 years [18-93], 55% had septic shock, 99% received norepinephrine alone, 91% received EN alone, and 50.3% were randomized to a usual protein dose. Forty-two percent of EEN patients had persistent organ dysfunction syndrome plus death at day 28, compared to 53% in the DEN group (p = 0.04). EEN was associated with more ICU-free days (9.3 ± 9.2 vs. 5.7 ± 7.9, p = 0.0002), more days alive and free of vasopressors (7.1 ± 3.1 vs. 6.3 ± 3.2, p = 0.007), and shorter duration of MV among survivors (9.8 ± 10.9 vs. 13.8 ± 14.5, p = 0.0002). This trend was no longer observed in the adjusted analysis. There were no differences in ICU/60-day mortality or feeding intolerance rates between groups.
CONCLUSION


In MV patients with circulatory shock, EEN, as compared to DEN, was associated with improved clinical outcomes, but no longer when adjusting for illness severity. RCTs comparing the efficacy of EEN to DEN in MV patients with circulatory shock are warranted.",2022,"We hypothesized early EN (EEN), as compared to delayed EN (DEN), is associated with improved clinical outcomes in mechanically ventilated (MV) patients with circulatory shock.
","['626 patients, from 52 ICUs in 14 countries', 'ICU patients', 'mechanically ventilated patients with circulatory shock', 'mechanically ventilated (MV) patients with circulatory shock', 'intensive care unit (ICU) patients with circulatory shock', 'MV patients with circulatory shock', 'Median age was 60\xa0years [18-93], 55% had septic shock, 99% received']","['enteral nutrition (EN) practices', 'EN alone', 'delayed enteral nutrition', 'RCTs', 'norepinephrine']","['persistent organ dysfunction syndrome plus death', 'shorter duration of MV', 'ICU/60-day mortality or feeding intolerance rates', 'days alive and free of vasopressors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0342953', 'cui_str': 'Organ dysfunction syndrome'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}]",626.0,0.187457,"We hypothesized early EN (EEN), as compared to delayed EN (DEN), is associated with improved clinical outcomes in mechanically ventilated (MV) patients with circulatory shock.
","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ortiz-Reyes', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Jayshil J', 'Initials': 'JJ', 'LastName': 'Patel', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical College of Wisconsin, Milwaukee, WI, USA. jpatel2@mcw.edu.'}, {'ForeName': 'Xuran', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Clinical Evaluation Research Unit, Department of Critical Care Medicine, Queen's University, KGH Research Institute, Kingston Health Sciences Centre, Kingston, ON, Canada.""}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Coz Yataco', 'Affiliation': 'Department of Critical Care Medicine and Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic, Cleveland, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Day', 'Affiliation': ""Clinical Evaluation Research Unit, Department of Critical Care Medicine, Queen's University, KGH Research Institute, Kingston Health Sciences Centre, Kingston, ON, Canada.""}, {'ForeName': 'Faraaz', 'Initials': 'F', 'LastName': 'Shah', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zelten', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Maximiliano', 'Initials': 'M', 'LastName': 'Tamae-Kakazu', 'Affiliation': 'Pulmonary and Critical Care Medicine, Spectrum Health, Michigan State University, East Lansing, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Clinical Evaluation Research Unit, Department of Critical Care Medicine, Queen's University, KGH Research Institute, Kingston Health Sciences Centre, Kingston, ON, Canada.""}]","Critical care (London, England)",['10.1186/s13054-022-04047-4']
1480,35681190,Comparison of the BOPPPS model and traditional instructional approaches in thoracic surgery education.,"BACKGROUND


BOPPPS (bridge-in, learning objective, pretest, participatory learning, posttest, and summary) is a student-centered modular teaching model that improves classroom teaching effectiveness. This study's primary aim was to explore whether the BOPPPS model has advantages over traditional instructional approaches in teaching lung cancer courses to clinical medical interns.
METHODS


A total of 88 students majoring in clinical medicine of Shandong First Medical University and Shandong University, who had clinical practice in thoracic surgery from January 2018 to December 2019, were divided into two groups, receiving the same lung cancer teaching content. The experimental group (n = 44) utilized the BOPPPS model, while the control group (n = 44) used the traditional instructional approach. A questionnaire was used to attain the students' satisfaction and self-evaluation of the course, and a post-study examination was used to assess end-of-course performance.
RESULTS


The experimental group's theoretical examination scores with the BOPPPS teaching model were significantly higher than those in the control group. Students preferred the BOPPPS model more than the traditional instructional approach in course satisfaction, student-teacher interaction, learning initiative, analytical ability, clinical thinking ability, and self-study ability (p < 0.05).
CONCLUSIONS


Compared with the traditional instructional approach. The BOPPPS model can better inspire clinical medical students' enthusiasm for thoracic surgery and enhance the students' comprehensive ability. In a word, the BOPPPS model has better teaching effectiveness in the clinical teaching practice of thoracic surgery, which is worthy of reference and popularization.",2022,The experimental group's theoretical examination scores with the BOPPPS teaching model were significantly higher than those in the control group.,"['thoracic surgery education', '88 students majoring in clinical medicine of Shandong First Medical University and Shandong University, who had clinical practice in thoracic surgery from January 2018 to December 2019']","['traditional instructional approach', 'BOPPPS model', 'BOPPPS model and traditional instructional approaches']","['course satisfaction, student-teacher interaction, learning initiative, analytical ability, clinical thinking ability, and self-study ability', 'theoretical examination scores with the BOPPPS teaching model']","[{'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008964', 'cui_str': 'Medicine, Clinical'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",88.0,0.0632423,The experimental group's theoretical examination scores with the BOPPPS teaching model were significantly higher than those in the control group.,"[{'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': ""Department of Thoracic Surgery, Jinan Central Hospital, Cheeloo College of Medicine, Shandong University, Jinan, 250013, People's Republic of China.""}, {'ForeName': 'Rui-Jie', 'Initials': 'RJ', 'LastName': 'Ma', 'Affiliation': ""Department of Thoracic Surgery, Jinan Central Hospital, Cheeloo College of Medicine, Shandong University, Jinan, 250013, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': ""School of Clinical Medicine, Weifang Medical University, Weifang, 261053, People's Republic of China.""}, {'ForeName': 'Qing-Kang', 'Initials': 'QK', 'LastName': 'Zheng', 'Affiliation': ""School of Clinical Medicine, Weifang Medical University, Weifang, 261053, People's Republic of China.""}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Sun', 'Affiliation': ""Department of Thoracic Surgery, Jinan Central Hospital, Cheeloo College of Medicine, Shandong University, Jinan, 250013, People's Republic of China. sunszg@126.com.""}]",BMC medical education,['10.1186/s12909-022-03526-0']
1481,35687604,Agility and change-of-direction speed are two different abilities also during the execution of repeated trials and in fatigued conditions.,"Agility and change of direction speed are two different abilities, but no study has investigated if this difference exists also in fatigued conditions, and whether fatigue develops in a different way in a repeated-trial scenario. Fourteen soccer players (age: 17.0 ± 0.4 yrs; height: 176.9 ± 6.5 cm; body mass: 69.2 ± 6.4 kg) competing in a national-level youth league completed in a randomized counter-balanced crossover design a repeated agility protocol (RA) and a repeated change-of-direction one (RCOD), both consisting in performing 20 consecutive repetitions (work:rest ratio 1:5). The 20 repetitions were divided into 4 blocks (each block containing 5 repetitions) for the analysis. Results show that agility and COD are two different abilities both in rest and fatigue conditions: block 1 RA vs 1 RCOD (p < 0.001; ES = 2.02 huge; r = 0.17 poor; r2 = 0.03), 2 RA vs 2 RCOD (p < 0.001; ES = 2.3 huge; r = 0.51 fair; r2 = 0.26), 3 RA vs 3 RCOD (p < 0.001; ES = 2.38 huge; r = 0.54 fair; r2 = 0.29), and 4 RA vs 4 RCOD (p < 0.001; ES = 2.7 huge; r = 0.41 fair; r2 = 0.17). However, the fatigue development in both conditions was similar, with a percentage decrement score (Sdec) of 7.5% for RA, and 7.3% for RCOD. Ratings of perceived exertions (RPE) were similar too (7.3 ± 1.7, and 6.6 ± 1.9, for RA and RCOD, respectively). However, a significant fatigue-related performance impairment arose earlier in RA (block 2) than in RCOD (block 3). Total RA and total RCOD times were significantly different (p < 0.001; ES = 2.65 huge; r = 0.41 fair; r2 = 0.17), suggesting that they are two different and independent abilities.",2022,"Total RA and total RCOD times were significantly different (p < 0.001; ES = 2.65 huge; r = 0.41 fair; r2 = 0.17), suggesting that they are two different and independent abilities.",['Fourteen soccer players (age: 17.0 ± 0.4 yrs; height: 176.9 ± 6.5 cm; body mass: 69.2 ± 6.4 kg) competing in a national-level youth league'],"['repeated agility protocol (RA) and a repeated change-of-direction one (RCOD), both consisting in performing 20 consecutive repetitions (work:rest ratio 1:5']","['Ratings of perceived exertions (RPE', 'Total RA and total RCOD times', 'Agility and change-of-direction speed']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",20.0,0.204464,"Total RA and total RCOD times were significantly different (p < 0.001; ES = 2.65 huge; r = 0.41 fair; r2 = 0.17), suggesting that they are two different and independent abilities.","[{'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Ciocca', 'Affiliation': 'Centre for Sports Science and University Sports, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tessitore', 'Affiliation': 'Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Rome, Italy.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Tschan', 'Affiliation': 'Centre for Sports Science and University Sports, University of Vienna, Vienna, Austria.'}]",PloS one,['10.1371/journal.pone.0269810']
1482,35687385,Informing a Randomized Control Trial in Rural Populations: Adaptation of a Diabetes Self-Management Education and Support Intervention.,"BACKGROUND


Over 34 million people in the United States have diabetes, with 1.5 million diagnosed every year. Diabetes self-management education and support (DSMES) is a crucial component of treatment to delay or prevent complications. Rural communities face many unique challenges in accessing DSMES, including geographic barriers and availability of DSMES programs that are culturally adapted to rural context.
OBJECTIVE


Boot Camp Translation (BCT) is an established approach to community-based participatory research used to translate complex clinical and scientific information into concepts, messages, and materials that are understandable, meaningful, and relevant to community members and patients. This study aimed to utilize BCT to adapt an existing DSMES program for delivery in rural primary care for English- and Spanish-speaking people with diabetes.
METHODS


The High Plains Research Network (HPRN) Community Advisory Council (C.A.C.) partnered with researchers at the University of Colorado and University of Utah to use BCT to aid in translating medical jargon and materials from an existing DSMES program, called ""Diabetes One Day (D1D)."" BCT consisted of 10 virtual meetings over a 6-month period among the C.A.C., which included 15 diverse community stakeholders. Both English-speaking and bilingual Spanish-English-speaking C.A.C. members were recruited to reflect the diversity of the rural communities in which the adapted program would be delivered.
RESULTS


The BCT process guided adaptations to D1D for use in rural settings (R-D1D). R-D1D adaptations reflect both content and delivery to assure that the intervention is appropriate and likely to be accepted by rural English- and Spanish-speaking people with diabetes. Additionally, BCT informed the design of recruitment and program materials and identification of recruitment venues. During the BCT process, the importance of tailoring materials to reflect culture differences in English- and Spanish-speaking patients was identified.
CONCLUSIONS


BCT was an effective strategy for academic researchers to partner with rural community members to adapt an existing DSMES intervention for delivery in rural areas to both English- and Spanish-speaking patients with diabetes. Through BCT, adaptations to recruitment materials and methods, program content and delivery, and supplemental materials were developed. The need to culturally adapt Spanish materials with input from stakeholders rather than simply translate materials into Spanish was highlighted. The importance of increasing awareness of the connection between diabetes and depression or diabetes distress, adaptations to include local foods, and the importance of the relationship between people with diabetes and their primary care practices were identified.",2022,"CONCLUSIONS


BCT was an effective strategy for academic researchers to partner with rural community members to adapt an existing DSMES intervention for delivery in rural areas to both English- and Spanish-speaking patients with diabetes.","['rural primary care for English- and Spanish-speaking people with diabetes', 'Rural Populations', '34 million people in the United States have diabetes, with 1.5 million diagnosed every year', 'The High Plains Research Network (HPRN']","['Diabetes self-management education and support (DSMES', 'DSMES intervention', 'Boot Camp Translation (BCT', 'BCT']",[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0040712', 'cui_str': 'Translations'}]",[],10.0,0.0211241,"CONCLUSIONS


BCT was an effective strategy for academic researchers to partner with rural community members to adapt an existing DSMES intervention for delivery in rural areas to both English- and Spanish-speaking patients with diabetes.","[{'ForeName': 'Tamara K', 'Initials': 'TK', 'LastName': 'Oser', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zittleman', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, United States.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Curcija', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, United States.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Kwan', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, United States.'}, {'ForeName': 'Shawnecca', 'Initials': 'S', 'LastName': 'Burke', 'Affiliation': 'Community Advisory Council, High Plains Research Network, Aurora, CO, United States.'}, {'ForeName': 'Sindy', 'Initials': 'S', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, United States.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Huss', 'Affiliation': 'Community Advisory Council, High Plains Research Network, Aurora, CO, United States.'}, {'ForeName': 'Marilee', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Community Advisory Council, High Plains Research Network, Aurora, CO, United States.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Sanchez', 'Affiliation': 'Community Advisory Council, High Plains Research Network, Aurora, CO, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Neuberger', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Iacob', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Simonetti', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Litchman', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, UT, United States.'}]",JMIR diabetes,['10.2196/35664']
1483,35687858,"Efficacy of HP-3070, an Asenapine Transdermal System, on Symptoms of Hostility in Adults With Schizophrenia: A Post Hoc Analysis of a 6-Week Phase 3 Study.","Objective:  Patients with schizophrenia may exhibit symptoms of hostility. HP-3070 is the first antipsychotic patch approved by the US Food and Drug Administration (FDA) for adults with schizophrenia. Its efficacy was demonstrated in a phase 3 study. This post hoc analysis assessed the efficacy of HP-3070 in treating hostility in schizophrenia.
Methods:  In the pivotal phase 3 study, conducted between August 2016 and November 2017, adults with schizophrenia (per  DSM-5  criteria) were randomized to HP-3070 3.8 mg/24 h, HP-3070 7.6 mg/24 h, or placebo. Least-squares mean (LSM) changes in Positive and Negative Syndrome Scale (PANSS) hostility item and PANSS-Excited Component (PANSS-EC) scores from baseline to week 6 were assessed post hoc using a mixed-effects model for repeated measures adjusted for selected PANSS-Positive symptoms and presence of somnolence or akathisia.
Results:  Among 442 patients with baseline PANSS hostility item score > 1 (n = 151, HP-3070 7.6 mg/24 h; n = 147, 3.8 mg/24 h; n = 144, placebo), week 6 LSM (95% CI) change from baseline (CFB) in hostility score was superior with HP-3070 versus placebo for 7.6 mg/24 h (-0.4 [-0.6 to -0.2];  P  < .001) and 3.8 mg/24 h (-0.3 [-0.6 to -0.1];  P  < .01), with similar results for 7.6 mg/24 h after adjusting for covariates ( P  < .05). For all patients regardless of baseline PANSS hostility item score, PANSS-EC week 6 LSM CFB was greater for HP-3070 7.6 mg/24 h (-1.1 [-1.9 to -0.4]; n = 203;  P  < .01) and 3.8 mg/24 h (-1.3 [-2.0 to -0.6]; n = 201;  P  < .001) than for placebo (n = 203), with similar results observed in patients with baseline hostility item score > 1.
Conclusions:  In this post hoc analysis, HP-3070 was superior to placebo in reducing schizophrenia-associated hostility, even after adjusting for covariates, suggesting these effects are at least partially independent of general antipsychotic effects or effects on sedation or akathisia. These findings suggest HP-3070 has a specific antihostility effect in patients with schizophrenia.
Clinical Trials Registration:  ClinicalTrials.gov identifier: NCT02876900; EudraCT number: 2015-005134-21.",2022,"In this post hoc analysis, HP-3070 was superior to placebo in reducing schizophrenia-associated hostility, even after adjusting for covariates, suggesting these effects are at least partially independent of general antipsychotic effects or effects on sedation or akathisia.","['442 patients with baseline PANSS hostility item score ', 'patients with schizophrenia', 'conducted between August 2016 and November 2017, adults with schizophrenia (per  DSM-5  criteria', 'adults with schizophrenia', 'Adults With Schizophrenia', 'Patients with schizophrenia may exhibit symptoms of hostility']","['HP-3070 3.8 mg/24 h, HP-3070 7.6 mg/24 h, or placebo', 'HP-3070', 'placebo']","['baseline PANSS hostility item score, PANSS-EC week 6 LSM CFB', 'hostility score', 'Least-squares mean (LSM) changes in Positive and Negative Syndrome Scale (PANSS) hostility item and PANSS-Excited Component (PANSS-EC) scores', 'sedation or akathisia', 'schizophrenia-associated hostility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009002', 'cui_str': 'Clofibrate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",442.0,0.168779,"In this post hoc analysis, HP-3070 was superior to placebo in reducing schizophrenia-associated hostility, even after adjusting for covariates, suggesting these effects are at least partially independent of general antipsychotic effects or effects on sedation or akathisia.","[{'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Citrome', 'Affiliation': 'Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, New York.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Komaroff', 'Affiliation': 'Research and Development, Noven Pharmaceuticals, Inc., Jersey City, New Jersey.'}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Starling', 'Affiliation': 'Research and Development, Noven Pharmaceuticals, Inc., Jersey City, New Jersey.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Byreddy', 'Affiliation': 'Research and Development, Noven Pharmaceuticals, Inc., Jersey City, New Jersey.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Terahara', 'Affiliation': 'Hisamitsu Pharmaceutical Co, Inc., Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Hasebe', 'Affiliation': 'Hisamitsu Pharmaceutical Co, Inc., Chiyoda-ku, Tokyo, Japan.'}]",The Journal of clinical psychiatry,['10.4088/JCP.21m14355']
1484,35687774,Effects of hydrodissection on anesthesia characteristics in ultrasound guided infraclavicular brachial plexus blockade.,"BACKGROUND


The development of ultrasonography technology and its widespread application have increased peripheral nerve block applications, especially in limb surgeries, since it reduces complication rates and increases success rates in peripheral nerve block applications. However, even experienced physicians need to direct a large number of needles and injections for adequate local anesthetic spread, which can cause accidental vascular puncture and local anesthetic systemic toxicity. Such complications can be prevented by hydrodissection and a safer and successful anesthesia can be provided to patients in this study, it was aimed to investigate the effects of hydrodissection on anesthesia characteristics in the infraclavicular brachial plexus blockade.
MATERIALS AND METHODS


Ninety patients were included in our study after approval by the Ethics Committee. These patients were randomly divided into 2 groups (Group I: Infraclavicular brachial plexus blockade with normal method and Group II: infraclavicular brachial plexus blockade with hydrodissection). After obtaining patient consent, monitoring and vascular access were provided. Group I patients were mixed with 30 mL of local anesthetic mixture (15 mL of distilled water and 15 mL of 0.5% bupivacaine), and Group II patients were treated with 15 mL of distilled water by hydrodissection and 15 mL of 0.5% bupivacaine anesthesia resident. Block characteristics were evaluated and recorded every 5 minutes for the first 30 minutes by a blinded observer. The sensory block score was 7, the total score was 14 or above, and the block was considered successful, and the patient was ready for surgery. Postoperative block removal times, analgesia, and complications were evaluated and recorded.
RESULTS


A significant difference was found between the sensory and motor block onset times and postoperative VAS scores between the normal and hydrodissection groups (P < .05). There were no significant differences in terms of block application times, postoperative block removal times, and complications between the groups.
CONCLUSION


In this study, it has been shown that hydrodissection in peripheral nerve blocks does not lag in terms of block success and characteristics compared to normal methods, whereas anesthetists with less experience in peripheral nerve block experience obtain safer and more successful results in practice.",2022,A significant difference was found between the sensory and motor block onset times and postoperative VAS scores between the normal and hydrodissection groups (P < .05).,"['ultrasound guided infraclavicular brachial plexus blockade', 'Ninety patients were included in our study after approval by the Ethics Committee']","['Infraclavicular brachial plexus blockade with normal method and Group II: infraclavicular brachial plexus blockade with hydrodissection', 'local anesthetic mixture (15\u200amL of distilled water and 15\u200amL of 0.5% bupivacaine', '15\u200amL of distilled water by hydrodissection and 15\u200amL of 0.5% bupivacaine anesthesia resident', 'hydrodissection']","['sensory block score', 'block application times, postoperative block removal times, and complications', 'sensory and motor block onset times and postoperative VAS scores', 'Postoperative block removal times, analgesia, and complications']","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}]","[{'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",90.0,0.0401114,A significant difference was found between the sensory and motor block onset times and postoperative VAS scores between the normal and hydrodissection groups (P < .05).,"[{'ForeName': 'Samet', 'Initials': 'S', 'LastName': 'Er', 'Affiliation': 'Halil Sivgin Cubuk State Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey.'}, {'ForeName': 'Semih', 'Initials': 'S', 'LastName': 'Baskan', 'Affiliation': 'Ankara City Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Akcay', 'Affiliation': 'Ankara City Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey.'}, {'ForeName': 'Feryal', 'Initials': 'F', 'LastName': 'Akcay', 'Affiliation': 'Ankara City Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Zengin', 'Affiliation': 'University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital, Anesthesiology and Reanimation Clinic, Ankara, Turkey.'}]",Medicine,['10.1097/MD.0000000000029241']
1485,35687936,Examining the influence of rurality on frequency of cannabis use and severity of consequences as moderated by age and gender.,"AIM


A number of important health disparities associated with place of residence have been reported in the literature. The Remoteness Index (RI) was developed to account for community size, population density, and proximity to larger population centres. This exploratory analysis uses the RI to examine community level associations related to cannabis use.
DESIGN


This secondary analysis uses data collected as part of a randomized controlled trial of a brief cannabis intervention. Participants' place of residence was matched to a corresponding value on the RI. Univariate regressions of RI and cannabis related outcomes were modeled with age and gender as moderating variables. Three outcomes were analyzed separately: 1) total number of days of cannabis use in the past 30 days; 2) risk of experiencing cannabis related problems; and 3) number of self-reported consequences related to cannabis.
FINDINGS


Participants living in more remote areas were significantly more likely to drive within an hour of using cannabis, but also reported fewer consequences and less risky cannabis use. Although the overall regression models tested in the moderation analyses were significant, there were no interaction effects between RI and age or gender.
CONCLUSION


While this analysis did not find significant conditional effects of age or gender on the relationship between cannabis use and place of residence, further research is needed to investigate other factors which may contribute to health disparities related to substance use between individuals living in different geographic regions.",2022,"The Remoteness Index (RI) was developed to account for community size, population density, and proximity to larger population centres.",[],[],['total number of days of cannabis use in the past 30\xa0days; 2) risk of experiencing cannabis related problems; and 3) number of self-reported consequences related to cannabis'],[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}]",,0.0603693,"The Remoteness Index (RI) was developed to account for community size, population density, and proximity to larger population centres.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schell', 'Affiliation': 'Institute of Mental Health and Policy Research, Centre for Addiction and Mental Health, Toronto, Canada; Dalla Lana School of Public Health, University of Toronto, Canada. Electronic address: christina.schell@camh.ca.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Godinho', 'Affiliation': 'Institute of Mental Health and Policy Research, Centre for Addiction and Mental Health, Toronto, Canada. Electronic address: alexandra.godinho@camh.ca.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cunningham', 'Affiliation': 'Institute of Mental Health and Policy Research, Centre for Addiction and Mental Health, Toronto, Canada; National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, United Kingdom; Department of Psychiatry, University of Toronto, Toronto, Canada. Electronic address: john.cunningham@kcl.ac.uk.'}]",Addictive behaviors,['10.1016/j.addbeh.2022.107385']
1486,35688590,"Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes.","INTRODUCTION


Robot-assisted surgery (RAS) and kinematic alignment (KA) are being increasingly adopted to improve patient outcomes in total knee arthroplasty (TKA). There is uncertainty around the individual or combined effect of these concepts compared with computer-assisted surgery (CAS) and mechanical alignment (MA), respectively. This study aims to assess the effectiveness of RAS, KA or both to improve clinical outcomes, functional measures, radiographic precision and prosthetic survivorship when compared with current gold standards of surgical care.
METHODS AND ANALYSIS


A national registry-nested, multicentre, double-blinded, 2×2 factorial, randomised trial will be undertaken with 300 patients undergoing primary unilateral TKA performed by 15 surgeons. The primary outcome will be the between-group differences in postoperative change over 2 years in the mean Knee injury and Osteoarthritis Outcome Score (KOOS-12), comparing first, RAS to CAS as its control, and second, KA to MA as its control. Secondary outcomes will include other knee-specific and general health patient-reported outcome measures (PROMs), intraoperative pressure loads as a measure of soft tissue balance, 6-month postoperative functional outcomes, radiological precision using CT imaging, complications and long-term prosthetic survivorship. The contribution of each patient's unique coronal plane alignment of the knee phenotype to primary and secondary PROMs will be investigated. OMERACT-OARSI criteria and Patient Acceptable Symptom State outcome score thresholds for the KOOS-12 and Oxford Knee Score will be used in secondary analyses. Primary intention-to-treat and secondary per-protocol analyses will be performed. Statistical analysis will include a generalised linear mixed model for repeated measures for continuous KOOS-12 scores. Kaplan-Meier estimates with adjusted HRs of implant survivorship will be calculated.
ETHICS AND DISSEMINATION


Ethics approval was obtained from Sydney Local Health District-Royal Prince Alfred Hospital (Approval X20-0494 and 2020/ETH02896 10.24/DEC20). Results will be submitted for publication in a peer-reviewed journal and presented in national, state and international meetings.
TRIAL REGISTRATION NUMBER


ACTRN12621000205831.",2022,"There is uncertainty around the individual or combined effect of these concepts compared with computer-assisted surgery (CAS) and mechanical alignment (MA), respectively.","['total knee arthroplasty (TKA', '300 patients undergoing primary unilateral TKA performed by 15 surgeons', 'Ethics approval was obtained from Sydney Local Health District-Royal Prince Alfred Hospital (Approval X20', 'total knee arthroplasty (RASKAL study']","['Robot-assisted surgery (RAS) and kinematic alignment (KA', 'Robotic-assisted surgery and kinematic alignment']","['postoperative change over 2 years in the mean Knee injury and Osteoarthritis Outcome Score (KOOS-12), comparing first, RAS to CAS as its control, and second, KA to MA as its control', 'clinical outcomes, functional measures, radiographic precision and prosthetic survivorship', 'knee-specific and general health patient-reported outcome measures (PROMs), intraoperative pressure loads as a measure of soft tissue balance, 6-month postoperative functional outcomes, radiological precision using CT imaging, complications and long-term prosthetic survivorship']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0949696', 'cui_str': 'Computer-Assisted Surgery'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",300.0,0.568281,"There is uncertainty around the individual or combined effect of these concepts compared with computer-assisted surgery (CAS) and mechanical alignment (MA), respectively.","[{'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'MacDessi', 'Affiliation': 'Orthopaedics, University of New South Wales, Sydney, New South Wales, Australia samuelmacdessi@sydneyknee.com.au.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Wernecke', 'Affiliation': 'Sydney Knee Specialists, Kogarah, New South Wales, Australia.'}, {'ForeName': 'Durga', 'Initials': 'D', 'LastName': 'Bastiras', 'Affiliation': 'Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hooper', 'Affiliation': 'Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Heath', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lorimer', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Harris', 'Affiliation': 'University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-051088']
1487,35688588,Effects of a nurse-led peer support intervention for stroke survivors: protocol for a randomised controlled trial.,"INTRODUCTION


Many stroke survivors have unmet psychosocial needs during the recovery phase following a stroke. There is emerging evidence that peer support interventions may play a valuable role in managing stroke. However, evidence regarding the effectiveness of peer support interventions on the psychosocial outcomes of stroke survivors is uncertain. This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.
METHODS AND ANALYSIS


This is an assessor-blinded two-arm randomised controlled trial. A convenience sample of 120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups. The participants allocated to the intervention group will receive the nurse-led peer support intervention, which includes 6 weekly peer support sessions facilitated by a nurse and at least one peer facilitator. Participants randomised to the control group will receive the same dose of interpersonal interaction as intervention participants, including weekly individual face-to-face session for 6 weeks. The primary outcomes are social participation and participation self-efficacy. The secondary outcomes are psychosocial distress, social support, stigma towards disease, self-efficacy in managing chronic conditions and quality of life. Data will be collected at baseline, immediately after the intervention and 3 months after the intervention. A process evaluation will be conducted qualitatively and quantitively to examine the mechanism by which the intervention impacts the psychosocial outcomes of stroke survivors. All outcomes will be analysed following the intention to treat principle. Generalised Estimation Equation models will be used to assess the intervention effect.
ETHICS AND DISSEMINATION


This protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2021.196-T). All participants will be required to provide written informed consent. Results of the study will be disseminated through publication in peer-reviewed journals and presentation at local or international conferences.
TRIAL REGISTRATION NUMBER


ChiCTR2100050853.",2022,"This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.
","['stroke survivors', '120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups']","['peer support interventions', 'nurse-led peer support intervention', 'nurse-led peer support intervention, which includes 6\u2009weekly peer support sessions facilitated by a nurse and at least one peer facilitator']","['psychosocial distress, social support, stigma towards disease, self-efficacy in managing chronic conditions and quality of life', 'social participation and participation self-efficacy']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}]",,0.173675,"This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.
","[{'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong xjwan@link.cuhk.edu.hk.'}, {'ForeName': 'Janita Pak Chun', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Yangzhou Hospital of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Yangzhou, China.'}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Outpatient Pharmacy, Wenfeng Community Health Service Centre, Yangzhou, China.'}, {'ForeName': 'Weijuan', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Medicine, Yangzhou University, Yangzhou, China.'}]",BMJ open,['10.1136/bmjopen-2022-062531']
1488,35688587,"Comparing propofol anaesthesia guided by Bispectral Index monitoring and frontal EEG wave analysis with standard monitoring in laparoscopic surgery: protocol for the 'EEG in General Anaesthesia - More Than Only a Bispectral Index' Trial, a multicentre, double-blind, randomised controlled trial.","INTRODUCTION


The use of Bispectral Index (BIS) monitors for assessing depth of sedation has led to a reduction in both the incidence of awareness and anaesthetic consumption in total intravenous anaesthesia. However, these monitors are vulnerable to artefacts. In addition to the processed number, the raw frontal electroencephalogram (EEG) can be displayed as a curve on the same monitor. Anaesthesia practitioners can learn to interpret the EEG in a short tutorial and may be quicker and more accurate thanBIS in assessing anaesthesia depth by recognising EEG patterns. We hypothesise that quality of recovery (QoR) in patients undergoing laparoscopic surgery is better, if propofol is titrated by anaesthesia practitioners able to interpret the EEG.
METHODS AND ANALYSIS


This is a multicentre, double-blind (patients and outcome assessors) randomised controlled trial taking place in four Swiss hospitals. Patients aged 18 years or older undergoing laparoscopic procedures with general anaesthesia using propofol and anaesthesia practitioners with more than 2 years experience will be eligible. The primary study outcome is the difference in QoR 24 hours after surgery. Secondary outcomes are propofol consumption, incidence of postoperative nausea and vomiting (PONV) and postoperative delirium.QoR and propofol consumption are compared between both groups using a two-sample t-test. Fisher's exact test is used to compare the incidences of PONV and delirium. A total of 200 anaesthesia practitioners (and 200 patients) are required to have an 80% chance of detecting the minimum relevant difference for the QoR-15 as significant at the 5% level assuming a SD of 20.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from all responsible ethics committees (lead committee: Ethikkommission Nordwest- und Zentralschweiz, 16 January 2021). The findings of the trial will be published in a peer-reviewed journal, presented at international conferences, and may lead to a change in titrating propofol in clinical practice.
TRIAL REGISTRATION NUMBER


www.
CLINICALTRIALS


gov:NCT04105660.",2022,Anaesthesia practitioners can learn to interpret the EEG in a short tutorial and may be quicker and more accurate thanBIS in assessing anaesthesia depth by recognising EEG patterns.,"['200 anaesthesia practitioners (and 200 patients', 'Patients aged 18 years or older undergoing laparoscopic procedures with general anaesthesia using propofol and anaesthesia practitioners with more than 2 years experience will be eligible', 'four Swiss hospitals', 'patients undergoing laparoscopic surgery']","['Bispectral Index (BIS) monitors', 'propofol', 'propofol anaesthesia guided by Bispectral Index monitoring and frontal EEG wave analysis with standard monitoring']","['propofol consumption, incidence of postoperative nausea and vomiting (PONV) and postoperative delirium', 'QoR and propofol consumption']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.586062,Anaesthesia practitioners can learn to interpret the EEG in a short tutorial and may be quicker and more accurate thanBIS in assessing anaesthesia depth by recognising EEG patterns.,"[{'ForeName': 'Bettina U', 'Initials': 'BU', 'LastName': 'Gruber', 'Affiliation': 'Department of Anaesthesiology, Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Girsberger', 'Affiliation': 'Department of Anaesthesiology, Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Kusstatscher', 'Affiliation': 'Department of Anaesthesiology, Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Funk', 'Affiliation': 'Clinic for Anaesthesiology, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Luethy', 'Affiliation': 'Department of Anaesthesiology, Kantonsspital Aarau AG, Aarau, Switzerland.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Jakus', 'Affiliation': 'Department of Anaesthesiology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Maillard', 'Affiliation': 'Department of Anaesthesiology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Luzius A', 'Initials': 'LA', 'LastName': 'Steiner', 'Affiliation': 'Clinic for Anaesthesiology, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Dell-Kuster', 'Affiliation': 'Clinic for Anaesthesiology, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph S', 'Initials': 'CS', 'LastName': 'Burkhart', 'Affiliation': 'Department of Anaesthesiology, Kantonsspital Graubünden, Chur, Switzerland christoph.Burkhart@ksgr.ch.'}]",BMJ open,['10.1136/bmjopen-2021-059919']
1489,35688460,Dexamethasone should not be given to people with a chronic subdural haematoma.,"The studyHutchinson P, Edlmann E, Bulters D, et al. Trial of dexamethasone for chronic subdural haematoma.  N Engl J Med  2020;383:2616-27.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/dexamethasone-should-not-be-used-chronic-subdural-haematoma/.",2022,"2020;383:2616-27.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/dexamethasone-should-not-be-used-chronic-subdural-haematoma/.",['people with a chronic subdural haematoma'],"['dexamethasone', 'Dexamethasone', 'https://evidence.nihr.ac.uk/alert/dexamethasone-should-not-be-used-chronic-subdural-haematoma']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}]",[],,0.145593,"2020;383:2616-27.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/dexamethasone-should-not-be-used-chronic-subdural-haematoma/.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Saul', 'Affiliation': 'NIHR Centre for Engagement and Dissemination, Twickenham, UK.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Gursul', 'Affiliation': 'NIHR Centre for Engagement and Dissemination, Twickenham, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Cassidy', 'Affiliation': 'NIHR Centre for Engagement and Dissemination, Twickenham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hutchinson', 'Affiliation': ""Addenbrooke's Hospital and University of Cambridge, UK.""}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Kolias', 'Affiliation': ""Addenbrooke's Hospital and University of Cambridge, UK.""}]",BMJ (Clinical research ed.),['10.1136/bmj.o1302']
1490,35681488,Effect of Sperm Selection by Magnetic-Activated Cell Sorting in D-IUI: A Randomized Control Trial.,"Clinical outcome in assisted reproduction techniques (ARTs) is mainly influenced by the quality of gametes used. It is known that a high percentage of sperm DNA fragmentation (DNAf) decreases the success of ART clinical results. Therefore, techniques such as magnetic-activated cell sorting (MACS) help to improve results in cases of patients with a high percentage of DNAf. Cryopreservation of sperm in donor intrauterine insemination (D-IUI) treatments increases sperm DNAf, so patients using these sperm samples can benefit from using this technique. This prospective randomized national multicenter study analyzed clinical outcomes of 181 D-IUI treatments. MACS was performed after density gradient centrifugation (DGC) in 90 thawed semen donor samples (MACSG), whereas only DGC was performed in 91 thawed semen donor samples (CG). To our knowledge, this is the first study analyzing the effect of MACS on D-IUI cycles. Our results show no significant differences in gestation, live birth, or miscarriage rates between the two groups. We believe that further studies with a larger sample size are needed to evaluate the application of MACS in combination with standard IUI donor sperm preparations in fertility clinics.",2022,"Our results show no significant differences in gestation, live birth, or miscarriage rates between the two groups.","['181 D-IUI treatments', 'D-IUI']","['MACS', 'magnetic-activated cell sorting (MACS', 'assisted reproduction techniques (ARTs']","['gestation, live birth, or miscarriage rates']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0007616', 'cui_str': 'Cell Isolation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035151', 'cui_str': 'Reproduction Techniques'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.0407031,"Our results show no significant differences in gestation, live birth, or miscarriage rates between the two groups.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'González-Ravina', 'Affiliation': 'IVI-RMA Seville, Avda. Américo Vespucio 19, 41092 Seville, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Santamaría-López', 'Affiliation': 'IVI-RMA Seville, Avda. Américo Vespucio 19, 41092 Seville, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pacheco', 'Affiliation': 'IVI-RMA Madrid, Avenida del Talgo 68, 28023 Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ramos', 'Affiliation': 'IVI-RMA Seville, Avda. Américo Vespucio 19, 41092 Seville, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Carranza', 'Affiliation': 'IVI-RMA Seville, Avda. Américo Vespucio 19, 41092 Seville, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Murria', 'Affiliation': 'IVI Foundation, Instituto de Investigación Sanitaria La Fe (IIS La Fe), 46026 Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz-Vallecillo', 'Affiliation': 'IVI Foundation, Instituto de Investigación Sanitaria La Fe (IIS La Fe), 46026 Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernández-Sánchez', 'Affiliation': 'IVI-RMA Seville, Avda. Américo Vespucio 19, 41092 Seville, Spain.'}]",Cells,['10.3390/cells11111794']
1491,35682121,The Comparative Effect of Reduced Mindfulness-Based Stress on Heart Rate Variability among Patients with Breast Cancer.,"Heart rate variability (HRV) is a powerful tool for observing interactions between the sympathetic and parasympathetic nervous systems. This study evaluated HRV during a mindfulness-based stress reduction (MBSR) program among women with breast cancer after receiving treatment. A quasi-experimental, nonrandomized design was used. Patients were allocated to usual care ( n  = 25) and MBSR ( n  = 25) groups. HRV was measured using recognized methods to assess the autonomic nervous system. Two-way ANOVA and  t -tests were used to examine HRV changes between and within groups, respectively. A significant interaction effect of time with group was observed on heart rate (F (1, 96) = 4.92,  p  = 0.029, η 2  = 0.049). A significant difference was also observed within the MBSR group preintervention and postintervention with regard to heart rate (t (24) = -3.80,  p  = 0.001), standard deviation of the RR interval (t (24) = 5.40,  p  &lt; 0.001), root-mean-square difference in the RR interval (t (24) = 2.23,  p  = 0.035), and high-frequency power (t (24) = 7.73,  p  &lt; 0.001). Large effect sizes for heart rate and SDNN of 0.94 and 0.85, respectively, were observed between the MBSR and usual care groups. This study provides preliminary evidence that an MBSR program may be clinically useful for facilitating parasympathetic activity associated with feelings of relaxation in treated breast cancer survivors.",2022,"A significant difference was also observed within the MBSR group preintervention and postintervention with regard to heart rate (t (24) = -3.80,  p  = 0.001), standard deviation of the RR interval (t (24) = 5.40,  ","['women with breast cancer after receiving treatment', 'treated breast cancer survivors', 'Patients with Breast Cancer']","['Reduced Mindfulness-Based Stress', 'mindfulness-based stress reduction (MBSR) program', 'MBSR program', 'MBSR']","['standard deviation of the RR interval', 'HRV', 'heart rate', 'Heart Rate Variability', 'Heart rate variability (HRV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0272305,"A significant difference was also observed within the MBSR group preintervention and postintervention with regard to heart rate (t (24) = -3.80,  p  = 0.001), standard deviation of the RR interval (t (24) = 5.40,  ","[{'ForeName': 'Shu-Jung', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, College of Medicine, National Taiwan University, No. 1, Ren-Ai Rd. Sec. 1, Taipei 10051, Taiwan.'}, {'ForeName': 'Yun-Chen', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'School of Nursing and Graduate Institute of Nursing, China Medical University, No. 100, Sec. 1, Jingmao Rd., Beitun Dist., Taichung 40604, Taiwan.'}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, College of Medicine, National Taiwan University, No. 1, Ren-Ai Rd. Sec. 1, Taipei 10051, Taiwan.'}, {'ForeName': 'Yuh-Ming', 'Initials': 'YM', 'LastName': 'Chang', 'Affiliation': 'Institute of Biochemistry, Microbiology, and Immunology, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Lo', 'Affiliation': 'Department of Hospitality Management, Chung Hua University, Hsinchu 30012, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19116537']
1492,35682056,The Impact of One-Time Relaxation Training on Attention Efficiency Measured by Continuous Performance Test in Depressive Disorders.,"Introduction : People with depression often complain of dysfunction in cognitive processes, particularly attention. Pharmacotherapy is one of the most commonly used methods of treating depressive disorders and related attention difficulties. Patients also benefit from various forms of psychotherapy and frequently support themselves with alternative therapeutic methods. The purpose of this study was to examine whether a 15-min-long relaxation training session could improve the efficiency of attention and perceptiveness in individuals diagnosed with depressive disorders.  Methods:  Forty-two individuals participated in the study, including 20 individuals diagnosed with recurrent depressive disorder (rDD) and 22 healthy subjects (comparison group, CG). The so-called continuous performance test in the Polish version (Attention and Perceptiveness Test, APT) was applied in the study. In the first stage, the participants completed the 6/9 version of the APT test and then took part in a 15-min relaxation training session (autogenic training developed by the German psychiatrist Johannes Heinrich Schultz). The next step of the study was to perform APT again (parallel version-3/8).  Results:  The analyses showed statistically significant differences ( p  &lt; 0.001) in the results obtained in the two versions of APT between the studied groups (rDD versus CG) in terms of the perceptual speed index. These differences were seen both before and after the introduction of the relaxation training. There was a statistically significant difference in the value of the perceptual speed index before and after the applied relaxation training for the subjects with depression ( p  = 0.004) and for the whole study group ( p  = 0.008). A significant correlation of illness symptom severity with decreased attentional efficiency was observed in the rDD group (perceptual speed index)-both before ( r  = -0.864;  p  &lt; 0.001) and after the relaxation training ( r  = -0.785;  p  &lt; 0.001).  Conclusions:  The continuous performance test (APT) is a reliable indicator of impaired attention efficiency among patients with depressive symptoms compared to healthy subjects. 15-min-long one-time relaxation exercise has a beneficial effect on attention efficiency measured by APT in people with depression.",2022,A significant correlation of illness symptom severity with decreased attentional efficiency was observed in the rDD group (perceptual speed index)-both before (,"['Depressive Disorders', 'Methods:  Forty-two individuals participated in the study, including 20 individuals diagnosed with recurrent depressive disorder (rDD) and 22 healthy subjects (comparison group, CG', 'individuals diagnosed with depressive disorders', 'people with depression', 'patients with depressive symptoms compared to healthy subjects']","['One-Time Relaxation Training', 'relaxation training session (autogenic training', '15-min-long relaxation training session', 'continuous performance test (APT']","['efficiency of attention and perceptiveness', 'Attention Efficiency', 'attentional efficiency', 'attention efficiency', 'perceptual speed index', 'illness symptom severity']","[{'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0349218', 'cui_str': 'Recurrent depressive disorder, unspecified'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0004361', 'cui_str': 'Autogenic therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003645', 'cui_str': 'APT'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",42.0,0.00823528,A significant correlation of illness symptom severity with decreased attentional efficiency was observed in the rDD group (perceptual speed index)-both before (,"[{'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Rucka', 'Affiliation': 'Institute of Psychology, Faculty of Educational Sciences, University of Lodz, ul. Smugowa 10/12, 90-433 Lodz, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Talarowska', 'Affiliation': 'Institute of Psychology, Faculty of Educational Sciences, University of Lodz, ul. Smugowa 10/12, 90-433 Lodz, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph19116473']
1493,35681986,Effects of Sedentary Behavior Interventions on Mental Well-Being and Work Performance While Working from Home during the COVID-19 Pandemic: A Pilot Randomized Controlled Trial.,"Sedentary behavior negatively impacts mental health, which can decrease employee productivity. Employee mental well-being and work performance may improve with sedentary reduction interventions, especially strategies that include environmental workplace modifications and behavior-changing strategies. However, such interventions have not been examined among employees working remotely during the COVID-19 pandemic. As part of the Stand Up Kansas program, 95 sedentary university employees working from home were randomized into one of four intervention arms: height-adjustable desk provision (Desk Only), online sedentary behavior modification program (Program Only), Desk + Program, or Control. The outcomes were measured at a baseline (November 2020) and following the 12-week intervention (February 2021). Employees reported mood (positive and negative affect), stress, fatigue (duration, interference with activities and severity) and work performance (irritability, focus, work satisfaction, non-work satisfaction and productivity) were measured using established self-report instruments. The effect sizes, by comparing the Control arm to the Desk + Program arm, revealed large improvements in mood (positive affect,  d  = 1.106). Moderate improvements were also seen in fatigue (duration,  d  = -0.533, and interference with activities,  d  = -0.648) and several aspects of work performance (focus,  d  = 0.702, work satisfaction,  d  = 0.751, and productivity,  d  = 0.572). Moderate effect sizes were also seen for positive affect ( d  = 0.566) and fatigue severity ( d  = 0.577) among the Program Only arm, whereas no noteworthy effect sizes were observed among the Desk Only arm. Combining an online sedentary behavior modification program with height-adjustable desk provisions appeared to positively affect mental well-being and work performance among remote employees.",2022,"Moderate improvements were also seen in fatigue (duration,  d  = -0.533, and interference with activities,  d  = -0.648) and several aspects of work performance (focus,  d  = 0.702, work satisfaction,  d  = 0.751, and productivity,  d  = 0.572).",['95 sedentary university employees working from home'],"['height-adjustable desk provision (Desk Only), online sedentary behavior modification program (Program Only), Desk + Program, or Control', 'Sedentary Behavior Interventions']","['fatigue (duration,  d  = -0.533, and interference with activities,  d  = -0.648) and several aspects of work performance', 'mood (positive and negative affect), stress, fatigue (duration, interference with activities and severity) and work performance (irritability, focus, work satisfaction, non-work satisfaction and productivity', 'fatigue severity', 'Mental Well-Being and Work Performance']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0147171,"Moderate improvements were also seen in fatigue (duration,  d  = -0.533, and interference with activities,  d  = -0.648) and several aspects of work performance (focus,  d  = 0.702, work satisfaction,  d  = 0.751, and productivity,  d  = 0.572).","[{'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Falk', 'Affiliation': 'School of Medicine, University of Kansas School of Medicine, Wichita, KS 67214, USA.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Mailey', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Hayrettin', 'Initials': 'H', 'LastName': 'Okut', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Wichita, KS 67214, USA.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Food, Nutrition, Dietetics and Health, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Food, Nutrition, Dietetics and Health, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Montney', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ablah', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Wichita, KS 67214, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph19116401']
1494,35681960,Relationship between Health Counselor Characteristics and Counseling Impact on Individuals at High-Risk for Lifestyle-Related Disease: Sub-Analysis of the J-HARP Cluster-Randomized Controlled Trial.,"Early diagnosis and treatment are necessary to prevent lifestyle-related diseases among high-risk individuals. This study aimed to examine the impact of counselor characteristics on clinic visits among individuals at high risk for lifestyle-related diseases. A total of 8975 patients aged 40 to 74 years with lifestyle-related comorbidities, who underwent an annual health checkup and received health counseling, were included in this study. Data intervention timing, mode of counseling, number of counseling sessions, and explanation methods were collected. We assessed the impact of counselor characteristics, including profession (public health nurse, clinical nurse, and nutritionist), age, and years of counseling experience, on counseling outcomes. The probability ratios (95% confidence intervals) of clinic visits were 1.22 (1.11-1.35) for public health nurses and 1.04 (0.90-1.20) for nurses compared with nutritionists. After adjustment for participant and counselor characteristics and initial timing, mode, and number of counseling sessions, the corresponding probability ratios (95% confidence intervals) were 1.16 (1.05-1.29) and 1.12 (0.95-1.31), respectively. Counselor age and years of experience did not influence clinic visits of the target population. Public health nurses were more effective in increasing clinic visits among the target population owing to their profession-specific knowledge, skills, and experience.",2022,"Public health nurses were more effective in increasing clinic visits among the target population owing to their profession-specific knowledge, skills, and experience.","['8975 patients aged 40 to 74 years with lifestyle-related comorbidities, who underwent an annual health checkup and received health counseling, were included in this study', 'Individuals at High-Risk for Lifestyle-Related Disease', 'individuals at high risk for lifestyle-related diseases']",[],"['clinic visits', 'probability ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0260860', 'cui_str': 'General medical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",8975.0,0.0464959,"Public health nurses were more effective in increasing clinic visits among the target population owing to their profession-specific knowledge, skills, and experience.","[{'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Noguchi', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Suita-shi 565-0871, Japan.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Kinuta', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Suita-shi 565-0871, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Sairenchi', 'Affiliation': 'Center for Research Collaboration and Support, Comprehensive Research Facilities for Advanced Medical Science, Dokkyo Medical University, Mibu-machi 321-0293, Japan.'}, {'ForeName': 'Miyae', 'Initials': 'M', 'LastName': 'Yamakawa', 'Affiliation': 'Geriatric Nursing, Division of Health Sciences, Graduate School of Medicine, Osaka University, Suita-shi 565-0871, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Koide', 'Affiliation': 'Division of Health Sciences, Graduate School of Medicine, Osaka University, Suita-shi 565-0871, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Katsura', 'Affiliation': 'Graduate School of Nursing, Miyagi University, Taiwa-cho 981-3298, Japan.'}, {'ForeName': 'Kazue', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': 'Department of Public Health Nursing, Fukuoka Jo Gakuin Nursing University, Fukuoka-shi 811-1313, Japan.'}, {'ForeName': 'Shizuko', 'Initials': 'S', 'LastName': 'Omote', 'Affiliation': 'Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa-shi 920-8640, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Imano', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Suita-shi 565-0871, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Suita-shi 565-0871, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Suita-shi 565-0871, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Iso', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Suita-shi 565-0871, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The J-Harp Research Group', 'Affiliation': ''}]",International journal of environmental research and public health,['10.3390/ijerph19116375']
1495,35682232,Exercise and Reduced Nicotine Content Cigarettes in Adult Female Smokers: A Pilot Trial.,"Background:  Although Reduced Nicotine Cigarettes (RNC) are suggested to improve smoking cessation and cardiometabolic health in relation to cancer risk, the effectiveness of exercise training with RNC on smoking cessation and cardiometabolic health is unknown.  Methods:  Female smokers (N = 27) were randomized to: (1) usual nicotine cigarettes (i.e., control), (2) RNC or (3) RNC plus exercise treatment for 12 weeks. Smoking withdrawal symptoms (e.g., Wisconsin Smoking Withdrawal Scale) and cardiometabolic health (e.g., weight, VO 2 max, resting respiratory exchange ratio (RER), glucose, HOMA-IR) were examined before and after treatment.  Results:  Treatments had no differential effect on weight ( p  = 0.80; partial η 2  = 0.29), VO 2 max ( p  = 0.20, partial η 2  = 0.18), or total cholesterol/HDL ratios ( p  = 0.59, partial η 2  = 0.06). However, RNC + Exercise tended to maintain RER (i.e., fat oxidation;  p  = 0.10, partial η 2  = 0.10) as well as insulin resistance ( p  = 0.13, partial η 2  = 0.25) and cortisol compared ( p  = 0.06, partial η 2  = 0.30) with control and RNC. Increased VO 2 max was also associated with lower nicotine dependence scores (r = -0.50,  p  &lt; 0.05).  Conclusion:  In this pilot study, improved fitness was associated with lower nicotine dependence. Additional work is warranted to examine the effects of exercise in smokers as a tool to improving smoking cessation and lower disease risk.",2022,"Increased VO 2 max was also associated with lower nicotine dependence scores (r = -0.50,  p  &lt; 0.05).  ","['Adult Female Smokers', 'Methods:  Female smokers (N = 27']","['usual nicotine cigarettes (i.e., control), (2) RNC or (3) RNC plus exercise treatment', 'RNC + Exercise', 'exercise training with RNC', 'Nicotine Cigarettes (RNC', 'Exercise and Reduced Nicotine Content Cigarettes']","['weight', 'insulin resistance', 'nicotine dependence scores', 'Smoking withdrawal symptoms (e.g., Wisconsin Smoking Withdrawal Scale) and cardiometabolic health (e.g., weight, VO 2 max, resting respiratory exchange ratio (RER), glucose, HOMA-IR', 'total cholesterol/HDL ratios']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C2938855', 'cui_str': 'Total cholesterol:HDL ratio measurement'}]",27.0,0.083187,"Increased VO 2 max was also associated with lower nicotine dependence scores (r = -0.50,  p  &lt; 0.05).  ","[{'ForeName': 'Chaofan', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Centre for Health Management and Policy Research, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Nengliang', 'Initials': 'N', 'LastName': 'Yao', 'Affiliation': 'Centre for Health Management and Policy Research, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Miller', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA 22904, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Macpherson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA 22904, USA.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Hassinger', 'Affiliation': 'Department of Medicine, University of Virginia, Charlottesville, VA 22904, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Love', 'Affiliation': 'Division of Endocrinology and Metabolism, University of Virginia, Charlottesville, VA 22904, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA 22904, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph19116647']
1496,35682217,"Effects of Team-Based Learning on Students' Teamwork, Learning Attitude, and Health Care Competence for Older People in the Community to Achieve SDG-3.","BACKGROUND


Team-based learning (TBL) was studied in several preclinical settings, but evidence for its effectiveness in community nursing education is scant. A community health care nursing course was developed, and nursing students engaged in TBL to achieve Sustainable Development Goal 3.
PURPOSE


This study aimed to examine the effect of TBL model integration on students' learning attitude, community understanding, and community care competence for achieving SDG 3 and determine the extent to which the TBL model altered students' nursing competence for providing community health care. We compared the effect of TBL and traditional learning (TL) in terms of community health care knowledge objectives.
METHODS


TBL was employed as the teaching strategy to guide students' discussion of community care issues, allowing them to fully utilize the knowledge acquired in their community practice. We used an unblinded crossover design, and 99 students participated in the community health nursing course.
RESULTS


The results demonstrated that TBL improved participants' community understanding and enhanced their skills for assessing and fulfilling community needs. The experimental and control groups differed significantly in their TBL performance, learning attitude, and nursing competencies. The performance of those who engaged in TBL was higher than that of those who engaged in TL on all community issues. TBL appears to be a more effective method than TL in terms of achieving nursing students' knowledge objectives.
CONCLUSIONS


Regarding practical application, the proposed intervention enables nursing students to acquire professional knowledge related to community aging health care and nursing skills, and establish partnerships with community residents. This facilitates the achievement of the United Nations' sustainable development goal of ensuring healthy living and promoting well-being at all ages.",2022,The performance of those who engaged in TBL was higher than that of those who engaged in TL on all community issues.,"['Older People in the Community to Achieve SDG-3', '99 students participated in the community health nursing course']","['TBL and traditional learning (TL', 'TBL model integration', 'Team-Based Learning', 'TBL']","['TBL performance, learning attitude, and nursing competencies', ""Students' Teamwork, Learning Attitude, and Health Care Competence""]","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0074247', 'cui_str': 'secoisolariciresinol'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009471', 'cui_str': 'Nursing, Community Health'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0582590', 'cui_str': 'Learning performance'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",99.0,0.023405,The performance of those who engaged in TBL was higher than that of those who engaged in TL on all community issues.,"[{'ForeName': 'Shang-Yu', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Department of Healthcare Administration, College of Medical and Health Science, Asia University, Taichung 41354, Taiwan.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Healthcare Administration, College of Medical and Health Science, Asia University, Taichung 41354, Taiwan.'}, {'ForeName': 'Pei-Lun', 'Initials': 'PL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Nursing, College of Health, National Taichung University of Science and Technology, Taichung 40401, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19116632']
1497,35682213,Ischemic Preconditioning Improves Handgrip Strength and Functional Capacity in Active Elderly Women.,"BACKGROUND


Aging decreases some capacities in older adults, sarcopenia being one of the common processes that occur and that interfered with strength capacity. The present study aimed to verify the acute effect of IPC on isometric handgrip strength and functional capacity in active elderly women.
METHODS


In a single-blind, placebo-controlled design, 16 active elderly women (68.1 ± 7.6 years) were randomly performed on three separate occasions a series of tests: (1) alone (control, CON); (2) after IPC (3 cycles of 5-min compression/5-min reperfusion at 15 mmHg above systolic blood pressure, IPC); and (3) after placebo compressions (SHAM). Testing included a handgrip isometric strength test (HIST) and three functional tests (FT): 30 s sit and stand up from a chair (30STS), get up and go time (TUG), and 6 min walk distance test (6MWT).
RESULTS


HIST significantly increased in IPC (29.3 ± 6.9 kgf) compared to CON (27.3 ± 7.1 kgf; 7.1% difference;  p  = 0.01), but not in SHAM (27.7 ± 7.9; 5.5%;  p  = 0.16). The 30STS increased in IPC (20.1 ± 4.1 repetitions) compared to SHAM (18.5 ± 3.5 repetitions; 8.7%;  p  = 0.01) and CON (18.5 ± 3.9 repetitions; 8.6%;  p  = 0.01). TUG was significantly lower in IPC (5.70 ± 1.35 s) compared to SHAM (6.14 ± 1.37 s; -7.2%;  p  = 0.01), but not CON (5.91 ± 1.45 s; -3.7%;  p  = 0.24). The 6MWT significantly increased in IPC (611.5 ± 93.8 m) compared to CON (546.1 ± 80.5 m; 12%;  p  = 0.02), but not in SHAM (598.7 ± 67.6 m; 2.1%;  p  = 0.85).
CONCLUSIONS


These data suggest that IPC can promote acute improvements in handgrip strength and functional capacity in active elderly women.",2022,"The 6MWT significantly increased in IPC (611.5 ± 93.8 m) compared to CON (546.1 ± 80.5 m; 12%;  p  = 0.02), but not in SHAM (598.7 ± 67.6 m; 2.1%;  p  = 0.85).
","['16 active elderly women (68.1 ± 7.6 years', 'Active Elderly Women', 'older adults', 'active elderly women']","['IPC', 'handgrip isometric strength test (HIST) and three functional tests (FT): 30 s sit and stand up from a chair (30STS), get up and go time (TUG), and 6 min walk distance test (6MWT', 'Ischemic Preconditioning', 'placebo compressions (SHAM', 'placebo']","['IPC', 'handgrip strength and functional capacity', '30STS increased in IPC', 'Handgrip Strength and Functional Capacity', 'isometric handgrip strength and functional capacity']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3160837', 'cui_str': 'Walking distance test'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}]",16.0,0.122374,"The 6MWT significantly increased in IPC (611.5 ± 93.8 m) compared to CON (546.1 ± 80.5 m; 12%;  p  = 0.02), but not in SHAM (598.7 ± 67.6 m; 2.1%;  p  = 0.85).
","[{'ForeName': 'Luiz Guilherme da Silva', 'Initials': 'LGDS', 'LastName': 'Telles', 'Affiliation': 'Physical Education and Sports Department, Federal University of Rio de Janeiro, Rio de Janeiro 21941-901, Brazil.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Billaut', 'Affiliation': 'Department of Kinesiology, Laval University, Quebec, QC G1V 0A6, Canada.'}, {'ForeName': 'Gélio', 'Initials': 'G', 'LastName': 'Cunha', 'Affiliation': 'Estácio de Sá University (UNESA), Rio de Janeiro 20261-063, Brazil.'}, {'ForeName': 'Aline de Souza', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'Physical Education and Sports Department, Federal University of Juiz de Fora, São Pedro 36036-900, Brazil.'}, {'ForeName': 'Estêvão Rios', 'Initials': 'ER', 'LastName': 'Monteiro', 'Affiliation': 'Physical Education and Sports Department, Federal University of Rio de Janeiro, Rio de Janeiro 21941-901, Brazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Barreto', 'Affiliation': 'Celso Lisboa University Center, Rio de Janeiro 20950-092, Brazil.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Leitão', 'Affiliation': 'Sciences and Technology Department, Superior School of Education of Polytechnic Institute of Setubal, 2910-761 Setúbal, Portugal.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Panza', 'Affiliation': 'Physical Education and Sports Department, Federal University of Juiz de Fora, São Pedro 36036-900, Brazil.'}, {'ForeName': 'Jeferson Macedo', 'Initials': 'JM', 'LastName': 'Vianna', 'Affiliation': 'Physical Education and Sports Department, Federal University of Juiz de Fora, São Pedro 36036-900, Brazil.'}, {'ForeName': 'Jefferson da Silva', 'Initials': 'JDS', 'LastName': 'Novaes', 'Affiliation': 'Physical Education and Sports Department, Federal University of Rio de Janeiro, Rio de Janeiro 21941-901, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph19116628']
1498,35682201,The STress-And-Coping suppoRT Intervention (START) for Chinese Women Undergoing Abortion: A Randomized Controlled Trial Protocol.,"BACKGROUND


Although undergoing an abortion is stressful for most women, little attention has been given to their psychological wellbeing. This protocol aims to assess the feasibility, acceptability, and primary effects of a complex intervention to promote positive coping behaviors and alleviate depression symptoms among Chinese women who have undergone an abortion.
METHODS


A two-arm randomized controlled trial design will be used. Participants will be recruited at their first appointment with the abortion clinic and randomly allocated to receive either the Stress-And-Coping suppoRT (START) intervention (in addition to standard abortion care) or standard care only. All participants will be followed-up at two- and six-weeks post-abortion. Approval has been granted by local and university ethics committees. This research was supported by an Australian Government Research Training Program Scholarship.
DISCUSSION


The results will assist refinement and further evaluations of the START intervention, contribute to improved abortion care practices in China, and enrich the evidence on improving women's psychological well-being following abortion in China.
TRIAL REGISTRATION


Registered at the Chinese Clinical Trials.gov: ChiCTR2100046101. Date of registration: 4 May 2021.",2022,"The results will assist refinement and further evaluations of the START intervention, contribute to improved abortion care practices in China, and enrich the evidence on improving women's psychological well-being following abortion in China.
","['Chinese women who have undergone an abortion', 'Participants will be recruited at their first appointment with the abortion clinic', 'Chinese Women Undergoing Abortion']","['STress-And-Coping suppoRT Intervention (START', 'Stress-And-Coping suppoRT (START) intervention (in addition to standard abortion care) or standard care only', 'complex intervention']",[],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0000789', 'cui_str': 'Abortion Clinics'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0150181', 'cui_str': 'Coping support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",[],,0.2104,"The results will assist refinement and further evaluations of the START intervention, contribute to improved abortion care practices in China, and enrich the evidence on improving women's psychological well-being following abortion in China.
","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'School of Nursing and Midwifery, Gold Coast Campus, Griffith University, Parklands Drive, Gold Coast, QLD 4215, Australia.'}, {'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Haidian District, Beijing 100191, China.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gamble', 'Affiliation': 'School of Nursing and Midwifery, Logan Campus, Griffith University, University Drive, Meadowbrook, Brisbane, QLD 4131, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Elder', 'Affiliation': 'School of Nursing and Midwifery, Gold Coast Campus, Griffith University, Parklands Drive, Gold Coast, QLD 4215, Australia.'}, {'ForeName': 'Jyai', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'School of Nursing and Midwifery, Logan Campus, Griffith University, University Drive, Meadowbrook, Brisbane, QLD 4131, Australia.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Creedy', 'Affiliation': 'School of Nursing and Midwifery, Logan Campus, Griffith University, University Drive, Meadowbrook, Brisbane, QLD 4131, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph19116611']
1499,35682192,Home-Based Frailty Prevention Program for Older Women Participants of Kayoi-No-Ba during the COVID-19 Pandemic: A Feasibility Study.,"This study presents a single-arm intervention that aimed to determine the feasibility of a three-month home-based exercise program to prevent the progression of frailty during COVID-19. We recruited four groups of Kayoi-no-ba, or community salons for frailty prevention, and a total of 69 community-dwelling older women who belonged to one of the Kayoi-no-ba in a preliminary study for a follow-up study. The intervention program was developed on the basis of the 5A approach, and the focus group by the volunteer leaders of Kayoi-no-ba. We adapted the National Center for Geriatrics and Gerontology Home Exercise Program for Older People for 10-min daily home-based exercise. For feasibility outcomes, 91.3% of the participants completed the intervention program, whereas the percentage of exercise performed was 86.5% during the intervention period. For health-related outcomes, the five times sit-to-stand test exhibited significant improvement after the intervention. The results of feasibility outcomes indicate that the program may be feasible due to the high rates of completion and exercise performed. Additionally, improvement was noted for the health indicators of the five times sit-to-stand test, which may help prevent frailty. The feasibility trial has provided the necessary data to design a future-cluster randomized controlled trial.",2022,"For health-related outcomes, the five times sit-to-stand test exhibited significant improvement after the intervention.","['Older Women Participants of Kayoi-No-Ba during the COVID-19 Pandemic', 'Older People for 10-min daily home-based exercise', 'We recruited four groups of Kayoi-no-ba, or community salons for frailty prevention, and a total of 69 community-dwelling older women who belonged to one of the Kayoi-no-ba in a preliminary study for a follow-up study']","['Kayoi-no-ba', 'Home-Based Frailty Prevention Program', 'three-month home-based exercise program']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],69.0,0.0275366,"For health-related outcomes, the five times sit-to-stand test exhibited significant improvement after the intervention.","[{'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Watanabe', 'Affiliation': 'Department of Frailty Research, Research Institute, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Masayo', 'Initials': 'M', 'LastName': 'Kojima', 'Affiliation': 'Department of Frailty Research, Research Institute, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Mikako', 'Initials': 'M', 'LastName': 'Yasuoka', 'Affiliation': 'Department of Frailty Research, Research Institute, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Chieko', 'Initials': 'C', 'LastName': 'Kimura', 'Affiliation': 'Senior Care Division, Welfare Department, Handa City, Handa 475-8666, Aichi, Japan.'}, {'ForeName': 'Koto', 'Initials': 'K', 'LastName': 'Kamiji', 'Affiliation': 'Department of Frailty Research, Research Institute, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Otani', 'Affiliation': 'Department of Frailty Research, Research Institute, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Tsujimura', 'Affiliation': 'Department of Frailty Research, Research Institute, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Frailty Research, Research Institute, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Nogimura', 'Affiliation': 'Department of Frailty Research, Research Institute, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Ozeki', 'Affiliation': 'Department of Frailty Research, Research Institute, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Osawa', 'Affiliation': 'Department of Rehabilitation Medicine, Hospital, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph19116609']
1500,35682148,Effects of Copenhagen Adduction Exercise on Muscle Architecture and Adductor Flexibility.,"Groin injuries are one of the most prevalent in sports, especially due to the hip adductor muscles' weakness, which is considered as a risk factor. The Copenhagen adduction exercise (CAE) has been demonstrated to increase the strength of adductor muscles, but its effects on the architectural characteristics and flexibility of the adductors has been little studied. The aim of the present study was to analyse the impact on the muscular architecture and flexibility of the adductor musculature after 8 weeks of CAE-based training and after 4 weeks of subsequent detraining. A sample of 45 active subjects (26.1 ± 2.8 years old) were randomly divided into a control group with no intervention and an experimental group with an intervention based on 8 weeks of CAE training and 4 weeks of subsequent detraining. The muscle thickness of adductors was measured before and after training and detraining using ultrasound imaging and hip abduction range with goniometry. A significant increase in muscle thickness (left leg: +17.83%, d = 1.77,  p  &lt; 0.001//right leg: +18.38%, d = 1.82,  p  &lt; 0.001) and adductor flexibility was found in the experimental group (left leg: +7.3%, d = 0.96,  p  &lt; 0.05//right leg: +7.15%, d = 0.94,  p  &lt; 0.05), and after detraining, both variables returned to their initial values. These results could indicate that CAE would be a suitable strategy to modify the architecture of the adductors and thus form part of training protocols designed for the prevention and rehabilitation of muscle injuries.",2022,"A significant increase in muscle thickness (left leg: +17.83%, d = 1.77,  p  &lt; 0.001//right leg: +18.38%, d = 1.82,  p  &lt; 0.001) and adductor flexibility was found in the experimental group (left leg: +7.3%, d = 0.96,  ",['45 active subjects (26.1 ± 2.8 years old'],"['CAE', 'Copenhagen Adduction Exercise', 'control group with no intervention and an experimental group with an intervention based on 8 weeks of CAE training and 4 weeks of subsequent detraining', 'Copenhagen adduction exercise (CAE']","['muscle thickness', 'muscle thickness of adductors', 'adductor flexibility', 'Muscle Architecture and Adductor Flexibility']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}]",45.0,0.00690377,"A significant increase in muscle thickness (left leg: +17.83%, d = 1.77,  p  &lt; 0.001//right leg: +18.38%, d = 1.82,  p  &lt; 0.001) and adductor flexibility was found in the experimental group (left leg: +7.3%, d = 0.96,  ","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Alonso-Fernández', 'Affiliation': 'Department of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Fernández-Rodríguez', 'Affiliation': 'Department of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Yaiza', 'Initials': 'Y', 'LastName': 'Taboada-Iglesias', 'Affiliation': 'Department of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Águeda', 'Initials': 'Á', 'LastName': 'Gutiérrez-Sánchez', 'Affiliation': 'Department of Special Didactics, Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19116563']
1501,35682140,Effects of 8-Week In-Season Contrast Strength Training Program on Measures of Athletic Performance and Lower-Limb Asymmetry in Male Youth Volleyball Players.,"Strength training using high and lower load such as contrast training (CST) seems to be beneficial as it addresses larger adaptive reserves in youth athletes. Therefore, the aim of this study was to investigate the effects of CST on dynamic balance (composite score during dynamic balance test (CS-YBT)), one repetition maximum lower-limb back squat (1RM), jumping performance (single-leg hop (SLH) or countermovement jump height (CMJ)), lower-limb asymmetry (predicted from the single-leg jump performance between two legs [ILA]) in elite youth male volleyball players. Thirty-one male youth volleyball players aged 14 years were randomly assigned to a CST group ( n  = 16) or a control group ( n  = 15). The tests were performed before and after 8 weeks of training. Significant group × time interactions was observed for CS-YBT [ p  &lt; 0.001, η p 2  = 0.70], 1RM [ p  &lt; 0.001, η p 2  = 0.95], SLH with right and left leg [ p  &lt; 0.001, η p 2  = 0.69 and 0.51], CMJ [ p  &lt; 0.001, η p 2  = 0.47]), whilst it was not notable in ILA [ p  &lt; 0.294]. Post hoc tests showed that CST group demonstrated greater improvement in all of the dependent variables from medium to large effect size (for all  p  &lt; 0.001). As a result, 8 weeks of CST twice a week can be an effective and efficient training along with volleyball training to improve skill-related fitness measures, except for lower-limb asymmetry in young volleyball players.",2022,Post hoc tests showed that CST group demonstrated greater improvement in all of the dependent variables from medium to large effect size (for all  p  &lt; 0.001).,"['youth athletes', 'elite youth male volleyball players', 'Thirty-one male youth volleyball players aged 14 years', 'Male Youth Volleyball Players', 'young volleyball players']","['Season Contrast Strength Training Program', 'Strength training using high and lower load such as contrast training (CST', 'CST']","['dynamic balance (composite score during dynamic balance test (CS-YBT)), one repetition maximum lower-limb back squat (1RM), jumping performance (single-leg hop (SLH) or countermovement jump height (CMJ)), lower-limb asymmetry', '1RM ', 'Athletic Performance and Lower-Limb Asymmetry', 'CS-YBT ']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0560172', 'cui_str': 'cSt'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0023221', 'cui_str': 'Leg length inequality'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}]",31.0,0.00975284,Post hoc tests showed that CST group demonstrated greater improvement in all of the dependent variables from medium to large effect size (for all  p  &lt; 0.001).,"[{'ForeName': 'Abdeltif', 'Initials': 'A', 'LastName': 'Mesfar', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar Said, Manouba University, Tunis 2010, Tunisia.'}, {'ForeName': 'Raouf', 'Initials': 'R', 'LastName': 'Hammami', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar Said, Manouba University, Tunis 2010, Tunisia.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Selmi', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar Said, Manouba University, Tunis 2010, Tunisia.'}, {'ForeName': 'Sabri', 'Initials': 'S', 'LastName': 'Gaied-Chortane', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar Said, Manouba University, Tunis 2010, Tunisia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Duncan', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry CV1 5FB, UK.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Bowman', 'Affiliation': 'Department of Athletic Training, College of Health Sciences, University of Lynchburg, Lynchburg, VA 24501, USA.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Nobari', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sports Science, Nord University, 7600 Levanger, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph19116547']
1502,35684105,The Matrix Matters: Beverage Carbonation Impacts the Timing of Caffeine Effects on Sustained Attention.,"Both caffeine and the perception of refreshment delivered by cooling, tingling, and mouth-watering flavors have individually been shown to positively impact cognitive performance and mood, though presently there is limited evidence on their possible combined effects. This study explored the contribution of refreshing compounds in beverages, namely, carbon dioxide and citric acid, on the acute effects of caffeine on sustained attention and self-rated physical and mental energy. A randomized, controlled crossover trial was conducted by testing three products: a carbonated caffeinated beverage; a comparator caffeinated beverage; and a flavor-matched control beverage. Findings from 24 healthy adults revealed product-dependent variations in cognitive performance during a 60-min visual sustained-attention task, suggesting that the carbonated-caffeinated beverage led to faster, greater and more consistent levels of accuracy, compared to the control beverage. Specifically, significant differences were found between: (1) the carbonated-caffeinated beverage and the caffeinated beverage, and (2) between the caffeinated beverage and the control beverage for number of hits, reaction time and false alarm scores. Both caffeinated beverages led to higher physical and mental energy, and lower physical and mental fatigue 60-min post-consumption. These findings suggest beneficial effects on sustained attention through the combination of caffeine with refreshing compounds.",2022,"Findings from 24 healthy adults revealed product-dependent variations in cognitive performance during a 60-min visual sustained-attention task, suggesting that the carbonated-caffeinated beverage led to faster, greater and more consistent levels of accuracy, compared to the control beverage.",['24 healthy adults'],"['caffeine', 'carbonated caffeinated beverage; a comparator caffeinated beverage; and a flavor-matched control beverage']","['number of hits, reaction time and false alarm scores', 'higher physical and mental energy, and lower physical and mental fatigue 60-min post-consumption', 'sustained attention and self-rated physical and mental energy', 'cognitive performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0007026', 'cui_str': 'Carbonate'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",24.0,0.0464621,"Findings from 24 healthy adults revealed product-dependent variations in cognitive performance during a 60-min visual sustained-attention task, suggesting that the carbonated-caffeinated beverage led to faster, greater and more consistent levels of accuracy, compared to the control beverage.","[{'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'De Longis', 'Affiliation': 'Brain Health Department, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Lerond', 'Affiliation': 'Brain Health Department, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Costello', 'Affiliation': 'Brain Health Department, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hudry', 'Affiliation': 'Brain Health Department, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}]",Nutrients,['10.3390/nu14112305']
1503,35684098,Vitamin D Supplementation on Carotid Remodeling and Stiffness in Obese Adolescents.,"Obesity is associated with vitamin D (VD) deficiency and arterial stiffness. This randomized control trial assessed the effects of VD supplementation during a weight-loss program on carotid intima-media thickness (IMT) and carotid compliance in obese adolescents. Participants were randomly assigned to receive either a 12-week lifestyle program with VD supplementation ( n  = 13), a lifestyle program without VD supplementation ( n  = 13) or a control group composed of normal-weight adolescents ( n  = 18). Serum total and free 25-hydroxyvitamin D (25(OH)D), IMT and carotid compliance were measured before and after the trial. Insufficiency in 25(OH)D concentration was found in 73% of obese participants compared to 22% among controls. Obese adolescents had lower free 25(OH)D and displayed higher IMT but lower carotid compliance than controls. Free 25(OH)D and IMT were negatively correlated in adolescents displaying VD insufficiency at baseline. After three months, total and free 25(OH)D increased in both groups. The changes of IMT and carotid compliance were similar between groups. The changes in IMT were correlated with the changes in total 25(OH)D in obese adolescents with VD insufficiency at baseline ( r  = -0.59,  p  = 0.03). While the lifestyle program with VD supplementation did not affect carotid compliance, IMT reduction was improved in obese adolescents.",2022,Obese adolescents had lower free 25(OH)D and displayed higher IMT but lower carotid compliance than controls.,"['Obese adolescents', 'obese adolescents', 'Obese Adolescents']","['VD supplementation', 'lifestyle program without VD supplementation ( n  = 13) or a control group composed of normal-weight adolescents', 'lifestyle program with VD supplementation', 'Vitamin D Supplementation']","['Insufficiency in 25(OH)D concentration', 'carotid compliance, IMT reduction', 'Serum total and free 25-hydroxyvitamin D (25(OH)D), IMT and carotid compliance', 'Free 25(OH)D and IMT', 'changes in IMT', 'total and free 25(OH)D', 'total 25(OH)D', 'Carotid Remodeling and Stiffness', 'carotid intima-media thickness (IMT) and carotid compliance', 'changes of IMT and carotid compliance']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.219157,Obese adolescents had lower free 25(OH)D and displayed higher IMT but lower carotid compliance than controls.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Morrissey', 'Affiliation': 'LAPEC UPR4278-Laboratoire de Pharm-Ecologie Cardiovasculaire, Avignon University, 84029 Avignon, France.'}, {'ForeName': 'Marie-Josèphe', 'Initials': 'MJ', 'LastName': 'Amiot', 'Affiliation': 'MOISA-Montpellier Interdisciplinary Center on Sustainable Agri-Food Systems, CIRAD-Centre de Coopération Internationale en Recherche Agronomique pour le Développement, Institut Agro-SupAgro, University Montpellier, INRAE-National Research Institute for Agriculture, Food and the Environment, CIHEAM-IAMM-International Centre for Advanced Mediterranean Agronomic Studies-Mediterranean Agronomic Institute of Montpellier, 34090 Montpellier, France.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Goncalves', 'Affiliation': 'APSY-V-Laboratoire APSY-v, University Nimes, 30021 Nîmes, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Raverdy', 'Affiliation': 'SSR-Centre de Soins de Suite et de Réadaptation, Institut Saint Pierre, 34250 Palavas-les-Flots, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Masson', 'Affiliation': 'SSR-Centre de Soins de Suite et de Réadaptation, Institut Saint Pierre, 34250 Palavas-les-Flots, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tardivel', 'Affiliation': 'UMR C2VN-Center for CardioVascular and Nutrition Research, Aix Marseille University, INSERM-National Institute of Health and Medical Research, INRAE-National Research Institute for Agriculture, Food and the Environment, 13385 Marseille, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Gayrard', 'Affiliation': 'LAPEC UPR4278-Laboratoire de Pharm-Ecologie Cardiovasculaire, Avignon University, 84029 Avignon, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Carrère', 'Affiliation': 'MOISA-Montpellier Interdisciplinary Center on Sustainable Agri-Food Systems, CIRAD-Centre de Coopération Internationale en Recherche Agronomique pour le Développement, Institut Agro-SupAgro, University Montpellier, INRAE-National Research Institute for Agriculture, Food and the Environment, CIHEAM-IAMM-International Centre for Advanced Mediterranean Agronomic Studies-Mediterranean Agronomic Institute of Montpellier, 34090 Montpellier, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Landrier', 'Affiliation': 'UMR C2VN-Center for CardioVascular and Nutrition Research, Aix Marseille University, INSERM-National Institute of Health and Medical Research, INRAE-National Research Institute for Agriculture, Food and the Environment, 13385 Marseille, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Vinet', 'Affiliation': 'LAPEC UPR4278-Laboratoire de Pharm-Ecologie Cardiovasculaire, Avignon University, 84029 Avignon, France.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Perez-Martin', 'Affiliation': 'Vascular Medicine Laboratory, Nimes University Hospital, 30900 Nimes, France.'}]",Nutrients,['10.3390/nu14112296']
1504,35684089,Muscle-Related Effect of Whey Protein and Vitamin D 3  Supplementation Provided before or after Bedtime in Males Undergoing Resistance Training.,"There is increasing evidence that dietary protein intake with leucine and vitamin D is an important factor in muscle protein synthesis. This study investigated the combined effects of consuming whey protein and vitamin D 3  in the evening before bedtime or in the morning after sleeping on muscle mass and strength. Healthy, untrained males ( N  = 42; Age = 18-24 year) were randomly assigned into three groups: before bedtime, after sleeping, and control. Subjects underwent a 6-week resistance training program in combination with supplements that provided 25 g whey protein and 4000 IU vitamin D 3  for the before bedtime and after sleeping groups and a 5 g maltodextrin placebo for the control group. A significant increase in serum vitamin D was observed in both before bedtime and after sleeping groups. All groups experienced a significant gain in leg press. However, the control group did not experience significant improvements in muscle mass and associated blood hormones that were experienced by the before bedtime and after sleeping groups. No significant differences in assessed values were observed between the before bedtime and after sleeping groups. These findings suggest that the combination of whey protein and vitamin D supplements provided either before or after sleep resulted in beneficial increases in muscle mass in young males undergoing resistance training that exceeded the changes observed without these supplements.",2022,All groups experienced a significant gain in leg press.,"['Healthy, untrained males ( N  = 42; Age = 18-24 year', 'young males undergoing resistance training', 'Males Undergoing Resistance Training']","['Whey Protein and Vitamin D', 'whey protein and vitamin D supplements', 'leucine and vitamin D', 'consuming whey protein and vitamin D', 'maltodextrin placebo']","['serum vitamin D', 'muscle mass and associated blood hormones', 'significant gain in leg press', 'muscle mass']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.0211058,All groups experienced a significant gain in leg press.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Meng', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Junqiang', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Exercise Biochemistry, Exercise Science School, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Benardot', 'Affiliation': 'Department of Nutrition, Georgia State University, Atlanta, GA 30303, USA.'}]",Nutrients,['10.3390/nu14112289']
1505,35684083,Adherence to Diet and Meal Timing in a Randomized Controlled Feeding Study of Time-Restricted Feeding.,"Adherence is critical in feeding studies to determine the efficacy of dietary interventions. This time-restricted intake of meals (TRIM) investigation was a controlled feeding study that randomized 41 participants to follow 12 weeks of time-restricted feeding (TRF) or a usual feeding pattern (UFP). Adherence was optimized through careful screening and participant orientation, flexibility in beverages and seasonings, and frequent contact between participants and staff. Adherence was measured daily using a self-administered diary form. We calculated the percentage of participant-days with perfect adherence to meal timing (ate all meals within their designated time window) and to food consumption (ate all study food and no non-study food). Adherence was compared between study arms, days of the week, and weeks of the study period using generalized estimating equations (GEE) regression. There was perfect adherence to meal timing on 87% of participant-days and to food consumption on 94% of participant-days, with no significant difference by arm. In UFP, but not TRF, participants had lower adherence to meal timing over the weekend ( p -value = 0.002) and during the first two weeks of intervention ( p -value = 0.03). A controlled feeding study randomizing free-living individuals to different meal timings achieved a high degree of adherence to meal timing and food consumption, utilizing multiple strategies.",2022,"A controlled feeding study randomizing free-living individuals to different meal timings achieved a high degree of adherence to meal timing and food consumption, utilizing multiple strategies.",['41 participants to follow 12 weeks of time-restricted feeding (TRF) or a usual feeding pattern (UFP'],[],['Adherence'],"[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",[],"[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",41.0,0.0347363,"A controlled feeding study randomizing free-living individuals to different meal timings achieved a high degree of adherence to meal timing and food consumption, utilizing multiple strategies.","[{'ForeName': 'Beiwen', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'White', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'May Thu Thu', 'Initials': 'MTT', 'LastName': 'Maw', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21287, USA.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21287, USA.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Guallar', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Nisa M', 'Initials': 'NM', 'LastName': 'Maruthur', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Pilla', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}]",Nutrients,['10.3390/nu14112283']
1506,35684082,Dietary Intake over a 7-Day Training and Game Period in Female Varsity Rugby Union Players.,"This study estimated the daily energy intake (EI) and energy expenditure (TDEE) in female varsity rugby union players during a weekly training/game cycle. Fifteen (nine forwards, six backs) players (20.5 ± 0.4 y, 167.1 ± 1.8 cm, 74.9 ± 2.9 kg) were monitored for a 7-day period (one fitness, two heavy training, one light training, one game, and two recovery days) during their regular season. The average EI throughout the week for all 15 players was 2158 ± 87 kcal. There were no significant differences between days, but the lowest EI (1921 ± 227 kcal) occurred on the mid-week recovery day and the highest on game day (2336 ± 231 kcal). The average TDEE was 2286 ± 168 kcal (~6% &gt; EI). The mean energy availability (EA) over the 7-day period was 31.1 ± 3.6 kcal/kg FFM/day for the group. Of the players, 14% were in the optimal EA range (&gt;45 kcal/kg FFM/day); 34% were in the moderate range (≥30-45 kcal/kg FFM/day); and 52% had a poor EA of &lt;30 kcal/kg FFM/day. Carbohydrate (3.38 ± 0.36 g/kg/day, 45% of EI); fat (1.27 ± 0.12 g/kg/day, 37% of EI); and protein (1.38 ± 0.12 g/kg/day, 18% of EI) consumption remained similar throughout the week ( p  &gt; 0.05). The players consumed 6% less energy than they expended, providing poor to moderate EA; therefore, daily carbohydrate intake recommendations were not met.",2022,"There were no significant differences between days, but the lowest EI (1921 ± 227 kcal) occurred on the mid-week recovery day and the highest on game day (2336 ± 231 kcal).","['Female Varsity Rugby Union Players', 'female varsity rugby union players during a weekly training/game cycle', 'Fifteen (nine forwards, six backs) players (20.5 ± 0.4 y, 167.1 ± 1.8 cm, 74.9 ± 2.9 kg']",[],"['mean energy availability (EA', 'daily energy intake (EI) and energy expenditure (TDEE']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517641', 'cui_str': '2.9'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]",,0.0596695,"There were no significant differences between days, but the lowest EI (1921 ± 227 kcal) occurred on the mid-week recovery day and the highest on game day (2336 ± 231 kcal).","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Traversa', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, QC H2W 1S4, Canada.'}, {'ForeName': 'Danielle L E', 'Initials': 'DLE', 'LastName': 'Nyman', 'Affiliation': 'Queens University, Kingston, ON K7L 3N6, Canada.'}, {'ForeName': 'Lawrence L', 'Initials': 'LL', 'LastName': 'Spriet', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON N1G 2W1, Canada.'}]",Nutrients,['10.3390/nu14112281']
1507,35689188,Impulsive Lifestyle Counselling versus treatment as usual to reduce offending in people with co-occurring antisocial personality disorder and substance use disorder: a post hoc analysis.,"OBJECTIVES


To assess the impact of a short psychoeducation intervention for antisocial personality disorder on offending after randomization to treatment.
DESIGN


Multicentre, superiority, non-blinded randomized controlled trial. Random assignment was conducted in blocks of varying sizes at a central randomization centre. Participants were followed using national register data until 365 days after randomization, migration, or death, whichever occurred first.
SETTING


Thirteen outpatient uptake areas in Denmark.
PARTICIPANTS


Patients with antisocial personality disorder in treatment for substance use disorders were randomized to treatment as usual (TAU, n = 80) or Impulsive Lifestyle Counselling (ILC, n = 96). A total of 165 patients could be linked to criminal records (TAU, n = 74; ILC, n = 91).
INTERVENTION


ILC is a brief psychoeducational program targeting antisocial behavior. The trial was conducted between January 2012 and June 2014.
OUTCOMES


Number of criminal offences leading to convictions based on national registers.
RESULTS


The mean number of offences was 2.76 in the TAU group (95% Poisson confidence interval [CI] = 2.39, 3.16) and 1.87 in the ILC group (95% CI = 0.97, 1.43). Negative binomial regression was used to assess total number of convictions, as well as convictions for violent, property, driving under the influence, and drug-related crimes. In both adjusted and unadjusted analyses, random assignment to ILC was associated with a lower number of total offences (incidence rate risk ratio [IRR] = 0.43, p = .013; adjusted IRR = 0.45, p < .001) and convictions related to violence (IRR = 0.19, p = .001 adjusted IRR = 0.19, p = .007) and property offences (unadjusted IRR = 0.30, p = 0.003, adjusted IRR = 0.42, p = 0.010). Differences between conditions were not significant for driving under the influence (unadjusted IRR = 0.49, p = .370; adjusted IRR = 0.53, p = .417) or drug offences (unadjusted IRR = 1.06, p = .907; adjusted IRR = 0.55, p = .223).
CONCLUSIONS


The ILC program shows promise in reducing offending behavior in people with comorbid substance use and antisocial personality disorder.
TRIAL REGISTRATION


ISRCTN registry, ISRCTN67266318 , 15/10/2012.",2022,"Differences between conditions were not significant for driving under the influence (unadjusted IRR = 0.49, p = .370; adjusted IRR = 0.53, p = .417) or drug offences (unadjusted IRR = 1.06, p = .907; adjusted IRR = 0.55, p = .223).
","['165 patients could be linked to criminal records (TAU, n\u2009=\u200974; ILC, n\u2009=\u200991', 'January 2012 and June 2014', 'people with co-occurring antisocial personality disorder and substance use disorder', 'Patients with antisocial personality disorder in treatment for substance use disorders', 'Thirteen outpatient uptake areas in Denmark', 'people with comorbid substance use and antisocial personality disorder']","['Impulsive Lifestyle Counselling', 'ILC', 'short psychoeducation intervention', 'usual (TAU, n\u2009=\u200980) or Impulsive Lifestyle Counselling (ILC, n\u2009=\u200996']","['mean number of offences', 'Number of criminal offences leading to convictions based on national registers']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0425167', 'cui_str': 'Has a criminal record'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0003431', 'cui_str': 'Antisocial personality disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",165.0,0.181844,"Differences between conditions were not significant for driving under the influence (unadjusted IRR = 0.49, p = .370; adjusted IRR = 0.53, p = .417) or drug offences (unadjusted IRR = 1.06, p = .907; adjusted IRR = 0.55, p = .223).
","[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hesse', 'Affiliation': 'Centre for Alcohol and Drug Research, Aarhus University, Bartholins Allé 10, 8000, Aarhus C, Denmark. mh.crf@psy.au.dk.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Del Palacio-Gonzalez', 'Affiliation': 'Centre for Alcohol and Drug Research, Aarhus University, Bartholins Allé 10, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Thylstrup', 'Affiliation': 'Centre for Alcohol and Drug Research, Aarhus University, Bartholins Allé 10, 8000, Aarhus C, Denmark.'}]",BMC psychiatry,['10.1186/s12888-022-04025-8']
1508,35689178,Spirometry as a motivator for smoking cessation among patients attending the smoking cessation clinic of Monastir.,"BACKGROUND


The choice of spirometry, a biomarker of lung health, as a motivator for smoking cessation is based on its fidelity in emphasizing tobacco adverse effects. Yet, there is a paucity of evidence on its efficacy, and the findings are currently inconclusive. The aim of this study was to determine whether a spirometry and lung age communication has an effect on smoking cessation rates.
METHODOLOGY


We conducted a randomized controlled trial among patients who attended the smoking cessation clinic (SCC) at Fattouma Bourguiba University Hospital in Monastir, from June 2017 to February 2020. Participants were assigned into two groups, a control arm receiving standard program and intervention arm receiving a spirometry and lung age announcement along with usual care. The primary outcomes were the smoking cessation rates after one year of follow-up between the intervention arm and the control arm.
RESULTS


At one-year endpoint, a total of 456 were reachable for assessment, 236 in control group and 220 in spirometry group, which leads to a loss rate equal to 8.8%. One-year smoking cessation rate was higher among the intervention group than among control group (25.5% versus 16.5%), with a considerable statistical significance (p = 0.019). Lung age was significantly higher at paired comparison with chronological age.
CONCLUSION


Smoking cessation is still a challenging procedure with a high risk of relapse, making very valuable any approach that may increase motivation in both unmotivated and motivated smokers. This study is an additional evidence for spirometry and lung age announcement as motivators for smoking cessation.
TRIAL REGISTRATION


Pan African Clinical Trial Registry database ( PACTR202110595729653 ), 06/10/ 2021.",2022,"One-year smoking cessation rate was higher among the intervention group than among control group (25.5% versus 16.5%), with a considerable statistical significance (p = 0.019).","['patients who attended the smoking cessation clinic (SCC) at Fattouma Bourguiba University Hospital in Monastir, from June 2017 to February 2020', 'patients attending the smoking cessation clinic of Monastir']",['control arm receiving standard program and intervention arm receiving a spirometry and lung age announcement along with usual care'],"['Lung age', 'smoking cessation rate', 'smoking cessation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.034486,"One-year smoking cessation rate was higher among the intervention group than among control group (25.5% versus 16.5%), with a considerable statistical significance (p = 0.019).","[{'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Ben Fredj', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University Hospital Fattouma Bourguiba, Monastir, Tunisia. manel-ben-fredj@hotmail.fr.'}, {'ForeName': 'Behaeddin', 'Initials': 'B', 'LastName': 'Garrach', 'Affiliation': 'Faculty of Medicine of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Cyrine', 'Initials': 'C', 'LastName': 'Bennasrallah', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University Hospital Fattouma Bourguiba, Monastir, Tunisia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Migaou', 'Affiliation': 'Faculty of Medicine of Monastir, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Hela', 'Initials': 'H', 'LastName': 'Abroug', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University Hospital Fattouma Bourguiba, Monastir, Tunisia.'}, {'ForeName': 'Wafa', 'Initials': 'W', 'LastName': 'Dhouib', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University Hospital Fattouma Bourguiba, Monastir, Tunisia.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Zemni', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University Hospital Fattouma Bourguiba, Monastir, Tunisia.'}, {'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'Kacem', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University Hospital Fattouma Bourguiba, Monastir, Tunisia.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Bouanene', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University Hospital Fattouma Bourguiba, Monastir, Tunisia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Belguith Sriha', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University Hospital Fattouma Bourguiba, Monastir, Tunisia.'}]",BMC public health,['10.1186/s12889-022-13583-1']
1509,35685192,Title-comparison of coronally advanced flap with chorion membrane vs coronally advanced flap with connective tissue graft in the treatment of multiple gingival recessions: a split-mouth randomised controlled study.,"Background:  The importance of esthetics has escalated over the years. The purpose of any perioplastic surgery is to address gingival recession while ensuring predictable root coverage and a pleasing appearance. An array of surgical procedures have been recommended for the management of recession defects. The present study compares the clinical and patient related outcome measures of coronally advanced flap with chorion membrane and connective tissue graft in the management of multiple adjacent gingival recessions.  Methods:  The study was a prospective randomized controlled trial which included eight systemically healthy patients with an age range of 30-44 years with 36 labial/buccal, multiple adjacent, Cairo's RT1 gingival recession defects, bilaterally.  CAF+CM was performed on one side whereas CAF+CTG was performed on the other side. The two groups were compared clinically at three and six months postoperatively.  Results:  There was statistically significant decrease in recession depth, recession width, probing depth and clinical attachment level in both the groups from baseline to three and six months. However, intergroup comparisons revealed no statistically significant difference. At six months, both groups showed statistically significant improvements in keratinized tissue width and gingival thickness. The gingival thickness of the CAF+CM group increased significantly at three and six months. In terms of root coverage aesthetic score (RES), there was no significant difference observed between the two groups. In terms of patient reported outcome measures (PROMS), patients preferred the CAF+CM technique.  Conclusion:  Within the limits of the current study, the use of chorion membrane resulted in considerable root coverage and increased gingival thickness. Periodontal regeneration can be facilitated by the distinctive features of the chorion membrane. Coronally advanced flap plus chorion membrane is a novel approach for root coverage procedures.",2022,"There was statistically significant decrease in recession depth, recession width, probing depth and clinical attachment level in both the groups from baseline to three and six months.","['multiple gingival recessions', ""eight systemically healthy patients with an age range of 30-44 years with 36 labial/buccal, multiple adjacent, Cairo's RT1 gingival recession defects, bilaterally""]","['Coronally advanced flap plus chorion membrane', 'coronally advanced flap with chorion membrane and connective tissue graft', 'perioplastic surgery', 'CAF+CM', 'coronally advanced flap with chorion membrane vs coronally advanced flap with connective tissue graft']","['gingival thickness', 'recession depth, recession width, probing depth and clinical attachment level', 'root coverage and increased gingival thickness', 'keratinized tissue width and gingival thickness', 'root coverage aesthetic score (RES']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008503', 'cui_str': 'Chorionic structure'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",8.0,0.0155348,"There was statistically significant decrease in recession depth, recession width, probing depth and clinical attachment level in both the groups from baseline to three and six months.","[{'ForeName': 'Sweta', 'Initials': 'S', 'LastName': 'Pradhan', 'Affiliation': 'Department of Periodontology, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, 575001, India.'}, {'ForeName': 'Neetha', 'Initials': 'N', 'LastName': 'Shetty', 'Affiliation': 'Professor and HOD, Department of Periodontology, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, 575001, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Kamath', 'Affiliation': 'Professor, Department of Periodontology, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, 575001, India.'}]",F1000Research,['10.12688/f1000research.110829.1']
1510,35685611,Comparison of the Effect of Anesthetic Agents on Blood Levels of Parathyroid Hormone and Ionized Calcium: A Prospective Randomized Controlled Trial.,"The aim of this randomized control trial is to compare the effect of anesthetic agents on blood levels of parathyroid hormone and ionized calcium. 77 American Society of Anesthesiologists I-II patients who would undergo laparoscopic cholecystectomy were enrolled into this prospective study and randomized into 3 groups with sealed envelope technique as Group S: sevoflurane, Group D: desflurane, and Group TIVA: total intravenous anesthesia. The first blood sample was used to check the baseline blood levels of parathyroid hormone and ionized calcium. In Group S or D, maintenance of anesthesia was being performed with 1 MAC (minimum alveolar concentration) sevoflurane or desflurane, respectively, while in Group TIVA, it was performed with 150 mcg/kg/min propofol and 1 mcg/kg/min remifentanil IV infusions. At the 30 th  minute of anesthesia and at the 1 st  hour of end of anesthesia, 2 nd  and 3 rd  blood samples, respectively, were used to check the blood levels of PTH and Ca. During perioperative period, hemodynamic parameters were also noted. Blood levels of parathyroid hormone at the 30 th  min after anesthesia were found to be significantly different between groups ( P =0,01). The PTH level at the 30 th  min after anesthesia was found significantly higher in Group S than that of Groups D and TIVA ( P =0.005 and  P =0.001, respectively). Blood levels of ionized calcium at 30 th  min after anesthesia were found significantly different between groups ( P =0,048). It was found significantly higher in Group TIVA than that in Group S ( P =0.024). Desflurane seems to be the best agent for parathyroidectomy procedures. Future research studies are needed to be conducted to reach out more correct and valuable outcomes.",2022,"Blood levels of ionized calcium at 30 th  min after anesthesia were found significantly different between groups ( P =0,048).",['77 American Society of Anesthesiologists I-II patients who would undergo laparoscopic cholecystectomy'],"['sealed envelope technique as Group S: sevoflurane, Group D: desflurane, and Group TIVA: total intravenous anesthesia', 'Desflurane', 'propofol and 1\u2009mcg/kg/min remifentanil IV infusions', 'sevoflurane or desflurane', 'Anesthetic Agents']","['Blood Levels of Parathyroid Hormone and Ionized Calcium', 'PTH level', 'Blood levels of parathyroid hormone', 'blood levels of parathyroid hormone and ionized calcium', 'Blood levels of ionized calcium', 'blood levels of PTH and Ca']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1300567', 'cui_str': 'mcg/kg/min'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0201927', 'cui_str': 'Measurement of serum ionized calcium'}]",77.0,0.0245565,"Blood levels of ionized calcium at 30 th  min after anesthesia were found significantly different between groups ( P =0,048).","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Mercanoglu Efe', 'Affiliation': 'Uludag University Medical Faculty, Department of Anesthesiology and Reanimation, Bursa, Turkey.'}, {'ForeName': 'Turkay', 'Initials': 'T', 'LastName': 'Kirdak', 'Affiliation': 'Uludag University Medical Faculty, Department of General Surgery, Bursa, Turkey.'}, {'ForeName': 'Gulnihal', 'Initials': 'G', 'LastName': 'Aykut', 'Affiliation': 'Uludag University Medical Faculty, Department of Anesthesiology and Reanimation, Bursa, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Kaya Argadal', 'Affiliation': 'Uludag University Medical Faculty, Department of Anesthesiology and Reanimation, Bursa, Turkey.'}, {'ForeName': 'Ekrem', 'Initials': 'E', 'LastName': 'Kaya', 'Affiliation': 'Uludag University Medical Faculty, Department of General Surgery, Bursa, Turkey.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Ersoy', 'Affiliation': 'Uludag University Medical Faculty, Department of Biochemistry, Bursa, Turkey.'}]",International journal of clinical practice,['10.1155/2022/7795004']
1511,35685610,"Effect of Vitamin D on Paraxonase-1, Total Antioxidant Capacity, and 8-Isoprostan in Children with Attention Deficit Hyperactivity Disorder.","Method


In this double-blind, randomized, placebo-controlled trial, 75 children (aged 6-12) diagnosed with ADHD were randomly assigned into two groups. The supplementation group received vitamin D3 (2000 IU), and the control group received a placebo for 3 months. Blood samples were collected at baseline and after intervention to analyze the 25(OH)D, paraxonase-1 activity (PON-1), Total Antioxidant Capacity (TAC), and 8-isoprostan levels.
Results


A significant rise in circulating 25(OH)D was observed in the vitamin D group versus the placebo group at the end of the study. There was no reduction in 8-isoprostan levels in the vitamin D group compared to the placebo group. Serum paraxonase-1 and TAC concentration decreased in both groups, but these alterations were not statistically significant in the treatment group versus the placebo group at the end of the intervention.
Conclusion


Vitamin D supplementation for 3 months did not have beneficial effects on biomarkers of oxidative stress status. To confirm these findings, further studies on children are suggested.",2022,"Serum paraxonase-1 and TAC concentration decreased in both groups, but these alterations were not statistically significant in the treatment group versus the placebo group at the end of the intervention.
","['75 children (aged 6-12) diagnosed with ADHD', 'Children with Attention Deficit Hyperactivity Disorder']","['Vitamin D supplementation', 'Vitamin D', 'vitamin D3', 'placebo', 'vitamin D']","['Blood samples', 'circulating 25(OH)D', '8-isoprostan levels', 'Paraxonase-1, Total Antioxidant Capacity, and 8-Isoprostan', '25(OH)D, paraxonase-1 activity (PON-1), Total Antioxidant Capacity (TAC), and 8-isoprostan levels', 'Serum paraxonase-1 and TAC concentration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",75.0,0.528267,"Serum paraxonase-1 and TAC concentration decreased in both groups, but these alterations were not statistically significant in the treatment group versus the placebo group at the end of the intervention.
","[{'ForeName': 'Niyaz', 'Initials': 'N', 'LastName': 'Mohammadzadeh Honarvar', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Samadi', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Seyedi Chimeh', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Gholami', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Bahrampour', 'Affiliation': 'Department of Nutrition, Science and Research Branch Islamic Azad University (SRBIAU), Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Jalali', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Effatpanah', 'Affiliation': 'School of Medicine, Ziaeian Hospital, International Campus, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeid', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Abdolahi', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Chamari', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of clinical practice,['10.1155/2022/4836731']
1512,35685608,Is Right Unilateral Transversus Abdominis Plane (TAP) Block Successful in Postoperative Analgesia in Laparoscopic Cholecystectomy?,"Background


Transversus abdominis plane (TAP) block is used for postoperative analgesia in laparoscopic cholecystectomy. In laparoscopic cholecystectomy, the incisions are located mainly on the upper right side of the abdomen.
Aims


We aim to determine the efficacy of less-invasive ultrasound-guided right unilateral oblique subcostal TAP block in laparoscopic cholecystectomy on postoperative analgesia by comparing patients undergoing bilateral TAP block and a control group.
Methods


Ninety patients were equally divided into control, unilateral, and bilateral TAP block groups. TAP blocks were conducted before anesthesia. No block was applied to the control group. Patients' demographics and postoperative pain, satisfaction, and nausea-vomiting scores and tramadol/ondansetron doses were evaluated.
Results


There was no significant difference in the verbal numerical rating scale for pain scores at rest and during coughing (VNRS-R and VNRS-C) between unilateral and bilateral TAP block groups at postoperative 1 hour, 2 hour, 4 hour, 8 hour, 12 hour, and 24 hours. In addition, VNRS-R and VNRS-C scores were significantly higher in the control group than in the other two groups. Tramadol consumption in the control group was significantly higher than in the unilateral and bilateral TAP block groups ( p  ≤ 0.01), while no significant difference was identified between unilateral and bilateral TAP block groups ( p =0.303). Nausea-vomiting scores and ondansetron consumption did not differ significantly between all the groups. Patient satisfaction was significantly higher in unilateral and bilateral groups ( p  < 0.01,  p  < 0.01) than in the control group, while there was no significant difference between unilateral and bilateral TAP block groups ( p =0.793).
Conclusions


Right unilateral TAP block provides postoperative analgesia as effective as bilateral TAP block in laparoscopic cholecystectomy.",2022,"Patient satisfaction was significantly higher in unilateral and bilateral groups ( p  < 0.01,  p  < 0.01) than in the control group, while there was no significant difference between unilateral and bilateral TAP block groups ( p =0.793).
","['Methods\n\n\nNinety patients were equally divided into control, unilateral, and bilateral TAP block groups', 'laparoscopic cholecystectomy', 'patients undergoing bilateral TAP block and a control group']","['\n\n\nTransversus abdominis plane (TAP) block', 'tramadol/ondansetron', 'Right Unilateral Transversus Abdominis Plane (TAP', 'invasive ultrasound-guided right unilateral oblique subcostal TAP block']","['Nausea-vomiting scores and ondansetron consumption', 'verbal numerical rating scale for pain scores', ""Patients' demographics and postoperative pain, satisfaction, and nausea-vomiting scores"", 'Tramadol consumption', 'VNRS-R and VNRS-C scores', 'Patient satisfaction']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",90.0,0.0705597,"Patient satisfaction was significantly higher in unilateral and bilateral groups ( p  < 0.01,  p  < 0.01) than in the control group, while there was no significant difference between unilateral and bilateral TAP block groups ( p =0.793).
","[{'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Ozciftci', 'Affiliation': 'Hitit University Faculty of Medicine, Department of Anesthesiology and Reanimation, Çorum Merkez, Turkey.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Sahiner', 'Affiliation': 'Hitit University Faculty of Medicine, Department of Anesthesiology and Reanimation, Çorum Merkez, Turkey.'}, {'ForeName': 'Ibrahim Tayfun', 'Initials': 'IT', 'LastName': 'Sahiner', 'Affiliation': 'Hitit University Faculty of Medicine, Department of General Surgery, Çorum Merkez, Turkey.'}, {'ForeName': 'Taylan', 'Initials': 'T', 'LastName': 'Akkaya', 'Affiliation': 'University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Anesthesiology and Reanimation and Pain Clinic, Ankara, Turkey.'}]",International journal of clinical practice,['10.1155/2022/2668215']
1513,35685605,A Comparative Study on Alvogyl and a Mixture of Black Seed Oil and Powder for Alveolar Osteitis: A Randomized Double-Blind Controlled Clinical Trial.,"Introduction


Alveolar osteitis (AO) is the most common complication faced by exodontia patients and is usually seen 24-74 hours after tooth extraction, heralded by severe throbbing pain.  Nigella sativa  is commonly known as black seed known to have anti-inflammatory and antibacterial properties along with other reparative properties that enhance bone formation. This study aimed to evaluate and compare the effects of Alvogyl and a mixture of  Nigella sativa  powder and oil in the treatment of dry sockets.
Materials and Methods


Sixty patients above the age of 18 and below 70 years, from both genders, who underwent extraction of teeth and were clinically diagnosed with a dry socket at the clinic of the College of Dentistry, Jouf University, Saudi Arabia, were included in this study. Pain scores were assessed after placement of the dressing at the following intervals: 5 minutes, 30 minutes, 60 minutes, 2 nd  day, 4 th  day, and 7 th  day. Patients were randomly allocated to three groups, namely, Group 1 (Alvogyl), Group 2 (mixture of  Nigella sativa 's powder and oil), and Group 3 (control). Pain relief and healing of the socket were compared between the three groups. The collected data were subjected to statistical analysis through Spearman's correlation test, independent  t -test, ANOVA, and post hoc test.
Results


A mixture of  Nigella sativa  powder and oil showed a statistically significant difference in relieving pain compared to the Alvogyl group. A mixture of  Nigella sativa 's powder and oil required fewer dressings when compared to the Alvogyl group.
Conclusion


A mixture of  Nigella sativa  powder and oil is the more efficacious dressing material for the management of dry sockets compared to Alvogyl. It provides immediate and complete pain relief and fewer numbers of repeated visits.",2022,A mixture of  Nigella sativa  powder and oil is the more efficacious dressing material for the management of dry sockets compared to Alvogyl.,"['Alveolar Osteitis', 'Sixty patients above the age of 18 and below 70\u2009years, from both genders, who underwent extraction of teeth and were clinically diagnosed with a dry socket at the clinic of the College of Dentistry, Jouf University, Saudi Arabia']","['Alvogyl and a Mixture of Black Seed Oil and Powder', ""Group 2 (mixture of  Nigella sativa 's powder and oil"", 'Alvogyl and a mixture of  Nigella sativa  powder and oil']","['Pain relief and healing of the socket', 'Pain scores', 'pain relief', 'relieving pain']","[{'cui': 'C0013240', 'cui_str': 'Alveolar periostitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}]","[{'cui': 'C0051530', 'cui_str': 'alvogyl'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",60.0,0.18387,A mixture of  Nigella sativa  powder and oil is the more efficacious dressing material for the management of dry sockets compared to Alvogyl.,"[{'ForeName': 'Zafar Ali', 'Initials': 'ZA', 'LastName': 'Khan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Diagnostic Sciences, College of Dentistry, Jouf University, Sakaka, Saudi Arabia.'}, {'ForeName': 'Namdeo', 'Initials': 'N', 'LastName': 'Prabhu', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Diagnostic Sciences, College of Dentistry, Jouf University, Sakaka, Saudi Arabia.'}, {'ForeName': 'Naseer', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Department of Prosthodontics, Altamash Institute of Dental Medicine, Karachi 75500, Pakistan.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Lal', 'Affiliation': 'Department of Prosthodontics, Altamash Institute of Dental Medicine, Karachi 75500, Pakistan.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Issrani', 'Affiliation': 'Department of Preventive Dentistry, College of Dentistry, Jouf University, Sakaka, Al Jouf 72345, Saudi Arabia.'}, {'ForeName': 'Afsheen', 'Initials': 'A', 'LastName': 'Maqsood', 'Affiliation': 'Department of Oral Pathology, Bahria University Dental College, Karachi 75530, Pakistan.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammad Khursheed', 'Initials': 'MK', 'LastName': 'Alam', 'Affiliation': 'Department of Preventive Dentistry, College of Dentistry, Jouf University, Sakaka, Al Jouf 72345, Saudi Arabia.'}]",International journal of clinical practice,['10.1155/2022/7756226']
1514,35685601,"Influence on Depression, Anxiety, and Satisfaction of the Relatives' Visit to Intensive Care Units prior to Hospital Admission for Elective Cardiac Surgery: A Randomized Clinical Trial.","Background


Intensive care units (ICUs) may produce stress on the relatives of patients that have long-term physiological and psychological implications.
Objectives


This study aimed to evaluate the effects of the relatives´ visit prior to hospital admission(s) on the patient's scheduled cardiac surgery regarding depression, anxiety, and satisfaction of the patient's family in an ICU.
Methods


A randomized clinical trial [NCT03605420] was carried out according to the CONSORT criteria. Thirty-eight relatives of ICU patients were recruited at an ICU and randomized into study groups. Experimental group participants ( n  = 19) consisted of relatives who received 1 ICU visit prior to the patient's admission. Control group participants ( n  = 19) consisted of patients' relatives who received standard care alone. A self-report test battery, including the Impact of Event Scale-Revised (IES-R) and the Hospital Anxiety and Depression Scale (HADS), was completed by the patient's relative prior to the patient's ICU admission and again three and 90 days after ICU discharge. Furthermore, the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU) and Critical Care Family Needs Inventory (CCFNI) were administered to help determine the respondents' satisfaction three days after the patient's ICU discharge.
Results


Statistically significant differences in FS-ICU results were found between control and experimental groups; no statistically significant differences were found in IES-R, HADS, and CCFNI results. Thus, members in the control group were more satisfied with the time elapsed to raise their concerns ( p =0.005), emotional support provided ( p =0.020), quality of care ( p =0.035), opportunities to express concerns and ask questions ( p =0.005), and general satisfaction with the ICU's decision-making ( p =0.003).
Conclusions


Relatives' satisfaction during patients' ICU admission may be impaired after their prior visit to the hospital admission. Relative's anxiety and depression scores did not seem to be significantly affected. Relatives´ visit prior to elective cardiac surgery hospital admission impaired their satisfaction in an ICU and may not be advisable for healthcare practice.",2022,"Statistically significant differences in FS-ICU results were found between control and experimental groups; no statistically significant differences were found in IES-R, HADS, and CCFNI results.","['Thirty-eight relatives of ICU patients', ""Experimental group participants ( n \u2009=\u200919) consisted of relatives who received 1 ICU visit prior to the patient's admission"", ""patient's scheduled cardiac surgery regarding depression, anxiety, and satisfaction of the patient's family in an ICU""]","['relatives´ visit prior to hospital admission(s', '\n\n\nIntensive care units (ICUs', 'standard care alone']","['Impact of Event Scale-Revised (IES-R) and the Hospital Anxiety and Depression Scale (HADS', 'IES-R, HADS, and CCFNI results', ""Depression, Anxiety, and Satisfaction of the Relatives' Visit"", 'general satisfaction', 'quality of care', 'FS-ICU results', ""Relative's anxiety and depression scores""]","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030673', 'cui_str': 'Patient Admission'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3472482', 'cui_str': 'Impact of event scale revised'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.141571,"Statistically significant differences in FS-ICU results were found between control and experimental groups; no statistically significant differences were found in IES-R, HADS, and CCFNI results.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'González-Martín', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Becerro-de-Bengoa-Vallejo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Moisés', 'Initials': 'M', 'LastName': 'Rodríguez-García', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Marta Elena', 'Initials': 'ME', 'LastName': 'Losa-Iglesias', 'Affiliation': 'Faculty of Health Sciences, Universidad Rey Juan Carlos, Móstoles, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Mazoteras-Pardo', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, School of Physiotherapy and Nursing, University of Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Palomo-López', 'Affiliation': 'University Center of Plasencia, Universidad de Extremadura, Plasencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-López', 'Affiliation': 'Research, Health and Podiatry Group, Department of Health Sciences, Faculty of Nursing and Podiatry, Industrial Campus of Ferrol, Universidade da Coruña, A Coruña, Spain.'}]",International journal of clinical practice,['10.1155/2022/1746782']
1515,35685595,Combined Efficacy of Balloon Occlusion and Uterine Artery Embolization on Coagulation Function in Patients with High-Risk Placenta Previa during Cesarean Section.,"Purpose


The present study was performed in order to investigate the conbined effect of balloon occlusion and uterine artery embolization on coagulation function in patients with high-risk placenta previa during cesarean section.
Methods


There involved a total of 38 patients with high-risk placenta previa undergoing cesarean section in our hospital from August 2019 to January 2021. The patients enrolled were randomly divided into study group (19 cases, receiving balloon occlusion combined with uterine artery embolization) and control group (19 cases, receiving conventional cesarean section). The operation time, intraoperative blood loss, plasma injection volume and hospital stay of the two groups were recorded. Moreover, the postoperative coagulation function indexes, including thrombin time (TT), fibrinogen (FBI), activated partial thromboplastin time (APTT) and prothrombin time (PT), were monitored and compared. Neonatal Apgar score and postoperative complications of the two groups were regarded as parameters for comparison.
Results


The intraoperative blood loss, plasma injection volume and hospital stay of the study group were significantly lower compared with the control group ( P  < 0.05), whereas the operation time of the two groups was comparable ( P  > 0.05). Compared with the control group, the levels of TT, APTT and PT were lower while the level of FBI was higher in the study group ( P  < 0.05). The Apgar 1-min and 5-min scores of newborns were compared between the two groups ( P  > 0.05). However, the incidence of postoperative complications in the study group showed evidently lower outcomes compared with the control group ( P  < 0.05).
Conclusion


The combined approach of balloon occlusion and uterine artery embolization offered potential for improving the coagulation function of patients with high-risk placenta previa during cesarean section. In addition, the approach reduced the amount of blood loss and plasma injection, shortened the length of hospital stay, which was believed available for wide clinical application.",2022,"The intraoperative blood loss, plasma injection volume and hospital stay of the study group were significantly lower compared with the control group ( P  < 0.05), whereas the operation time of the two groups was comparable ( P  > 0.05).","['Patients with High-Risk Placenta Previa during Cesarean Section', '38 patients with high-risk placenta previa undergoing cesarean section in our hospital from August 2019 to January 2021', 'patients with high-risk placenta previa during cesarean section']","['balloon occlusion and uterine artery embolization', 'balloon occlusion combined with uterine artery embolization) and control group (19 cases, receiving conventional cesarean section', 'Balloon Occlusion and Uterine Artery Embolization']","['Coagulation Function', 'coagulation function', 'operation time', 'postoperative coagulation function indexes, including thrombin time (TT), fibrinogen (FBI), activated partial thromboplastin time (APTT) and prothrombin time (PT', 'Apgar 1-min and 5-min scores of newborns', 'Neonatal Apgar score and postoperative complications', 'postoperative complications', 'blood loss and plasma injection, shortened the length of hospital stay', 'operation time, intraoperative blood loss, plasma injection volume and hospital stay', 'levels of TT, APTT and PT', 'intraoperative blood loss, plasma injection volume and hospital stay', 'level of FBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032046', 'cui_str': 'Placenta previa'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0729536', 'cui_str': 'Embolization of uterine artery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0677634', 'cui_str': 'Reptilase time'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",38.0,0.0250088,"The intraoperative blood loss, plasma injection volume and hospital stay of the study group were significantly lower compared with the control group ( P  < 0.05), whereas the operation time of the two groups was comparable ( P  > 0.05).","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Obstetrics and Gynecology, Gezhouba Central Hospital of Sinopharm, China Three Gorges University, Yichang, Hubei, China.'}, {'ForeName': 'Xiayun', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, Gezhouba Central Hospital of Sinopharm, China Three Gorges University, Yichang, Hubei, China.'}]",International journal of clinical practice,['10.1155/2022/7750598']
1516,35685551,Application of Suctioning Ureteral Access Sheath during Flexible Ureteroscopy for Renal Stones Decreases the Risk of Postoperative Systemic Inflammatory Response Syndrome.,"Purpose


To clarify the efficiency and outcomes of suctioning ureteral access sheath (UAS) during flexible ureteroscopic lithotripsy (fURL) for the management of renal stones.
Methods


Between January 2017 and January 2019, a total of 444 patients with renal stones undergoing fURL were divided into suctioning UAS and nonsuctioning UAS groups. The outcomes of patients in both groups were compared using a matched-pair analysis (1 : 1 scenario). Furthermore, a directed acyclic graph (DAG) was drawn to guide the multivariate logistic regression model and analyze the protective effect of suctioning UAS on the incidence of postoperative systemic inflammatory response syndrome (SIRS).
Results


Before propensity score matching, significant differences were observed between the two groups in blood white cell counts, urine white cell counts, preoperative fever, preoperative indwelling stents, and laterality ( P  < 0.05). Eighty-one patients in the suctioning UAS group were successfully matched with 81 patients in the nonsuctioning group. The stone-free rate (SFR) on postoperative day 1 after fURL in the suctioning group was higher than that in the nonsuctioning group (86.4% vs. 71.6%;  P =0.034), whereas it was comparable between the two groups 1 month after the surgery (88.9% vs. 82.7%;  P =0.368). The incidence of postoperative fever or SIRS was lower in the suctioning group (fever: 3.70% vs. 14.8%;  P =0.030; SIRS: 1.23% vs. 12.3%;  P =0.012). However, the operative duration was similar in both groups (mean (SD)) (72.9 (28.1) min vs. 80.0 (29.5) min;  P =0.121). The result of the multivariate logistic regression model guided by DAG revealed that the application of nonsuctioning UAS (odds ratio: 5.28 [1.38-35.07],  P =0.034) during fURL was associated with postoperative SIRS.
Conclusions


The application of suctioning UAS during fURL was associated with higher SFR on day 1 after surgery and a lower incidence of postoperative fever or SIRS.",2022,"The stone-free rate (SFR) on postoperative day 1 after fURL in the suctioning group was higher than that in the nonsuctioning group (86.4% vs. 71.6%;  P =0.034), whereas it was comparable between the two groups 1 month after the surgery (88.9% vs. 82.7%;  P =0.368).","['Methods\n\n\nBetween January 2017 and January 2019, a total of 444 patients with renal stones undergoing fURL were divided into suctioning UAS and nonsuctioning UAS groups']","['suctioning UAS', 'flexible ureteroscopic lithotripsy (fURL', 'suctioning ureteral access sheath (UAS', 'Suctioning Ureteral Access Sheath during Flexible Ureteroscopy']","['stone-free rate (SFR) on postoperative day 1 after fURL', 'operative duration', 'blood white cell counts, urine white cell counts, preoperative fever, preoperative indwelling stents, and laterality', 'incidence of postoperative fever or SIRS']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0023114', 'cui_str': 'Handedness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0424786', 'cui_str': 'Postoperative fever'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}]",444.0,0.0405428,"The stone-free rate (SFR) on postoperative day 1 after fURL in the suctioning group was higher than that in the nonsuctioning group (86.4% vs. 71.6%;  P =0.034), whereas it was comparable between the two groups 1 month after the surgery (88.9% vs. 82.7%;  P =0.368).","[{'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Chenqian', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Senyuan', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jinzhou', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Department of Traditional Chinese Medicine and Rheumatology, Southwest Hospital, Army Military Medical University, Chongqing, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Shaogang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jiaqiao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",International journal of clinical practice,['10.1155/2022/9354714']
1517,35685548,Application of Enhanced T1WI of MRI Radiomics in Glioma Grading.,"Objective


To explore the application value of the radiomics method based on enhanced T1WI in glioma grading.
Materials and Methods


A retrospective analysis was performed using data of 114 patients with glioma, which was confirmed using surgery and pathological tests, at our hospital between January 2017 and November 2020. The patients were randomly divided into the training and test groups in a ratio of 7 : 3. The Analysis Kit (AK) software was used for radiomic analysis, and a total of 461 tumor texture features were extracted. Spearman correlation analysis and the least absolute shrinkage and selection (LASSO) algorithm were employed to perform feature dimensionality reduction on the training group. A radiomics model was then constructed for glioma grading, and the validation group was used for verification.
Results


The area under the ROC curve (AUC) of the proposed model was calculated to identify its performance in the training group, which was 0.95 (95% CI = 0.905-0.994), accuracy was 84.8%, sensitivity was 100%, and specificity was 77.8%. The AUC of the validation group was 0.952 (95% CI = 0.871-1.000), accuracy was 93.9%, sensitivity was 90.0%, and specificity was 95.6%.
Conclusions


The radiomics model based on enhanced T1WI improved the accuracy of glioma grading and better assisted clinical decision-making.",2022,The radiomics model based on enhanced T1WI improved the accuracy of glioma grading and better assisted clinical decision-making.,"['114 patients with glioma, which was confirmed using surgery and pathological tests, at our hospital between January 2017 and November 2020']",[],"['sensitivity', 'accuracy', 'area under the ROC curve (AUC', 'least absolute shrinkage and selection (LASSO']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]",114.0,0.0378629,The radiomics model based on enhanced T1WI improved the accuracy of glioma grading and better assisted clinical decision-making.,"[{'ForeName': 'Hongzhang', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Medical College of Nanchang University, Nanchang 330036, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang 330006, China.""}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang 330006, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical College of Nanchang University, Nanchang 330036, China.'}, {'ForeName': 'Qiyun', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang 330006, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang 330006, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang 330006, China.""}]",International journal of clinical practice,['10.1155/2022/3252574']
1518,35685538,The Effect of Ondansetron on the Analgesic Efficacy of Tramadol in Patients Undergoing Laparoscopic Cholecystectomy.,"Purpose


Investigating the effect of ondansetron on the efficacy of tramadol in patients undergoing laparoscopic cholecystectomy.
Methods


Sixty American Society of Anesthesiologists (ASA) I-II patients over the age of 18 who underwent laparoscopic cholecystectomy were included in this study. All patients were given 1 mg/kg tramadol intravenously (iv) during the intraoperative period. Patients were randomly assigned to receive either 4 mg ondansetron (Group O) or 2 mL saline (Group S). Postoperative tramadol consumption, pain score (NRS), intensity of nausea (NRS), presence of vomiting, consumption of rescue analgesics and antiemetics, and patient satisfaction were recorded.
Results


A total of 60 patients were enrolled in the study; five patients were excluded due to deviation from the protocol. Data from 55 patients (Group O: 28 patients, Group S: 27 patients) were evaluated in the study. No differences between the two groups were detected for postoperative consumption of tramadol, pain score (NRS), intensity of nausea (NRS), presence of vomiting, consumption of rescue analgesics and antiemetics, and patient satisfaction.
Conclusions


The results showed that coadministration of tramadol and ondansetron did not change tramadol consumption during the postoperative 24 hours after laparoscopic cholecystectomy. Clinical trial registration number is as follows: https://clinicaltrials.gov/ct2/show/NCT04745273-01/31/2021.",2022,"No differences between the two groups were detected for postoperative consumption of tramadol, pain score (NRS), intensity of nausea (NRS), presence of vomiting, consumption of rescue analgesics and antiemetics, and patient satisfaction.
","['patients undergoing laparoscopic cholecystectomy', '55 patients (Group O: 28 patients, Group S: 27 patients', 'Patients Undergoing Laparoscopic Cholecystectomy', 'Methods\n\n\nSixty American Society of Anesthesiologists (ASA', '60 patients were enrolled in the study; five patients were excluded due to deviation from the protocol', 'I-II patients over the age of 18 who underwent']","['ondansetron', 'Ondansetron', 'tramadol and ondansetron', 'Tramadol', 'laparoscopic cholecystectomy', 'ondansetron (Group O) or 2\u2009mL saline', 'tramadol']","['tramadol consumption', 'postoperative consumption of tramadol, pain score (NRS), intensity of nausea (NRS), presence of vomiting, consumption of rescue analgesics and antiemetics, and patient satisfaction', 'Postoperative tramadol consumption, pain score (NRS), intensity of nausea (NRS), presence of vomiting, consumption of rescue analgesics and antiemetics, and patient satisfaction', 'Analgesic Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0427626', 'cui_str': 'Group O'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0427626', 'cui_str': 'Group O'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0781112,"No differences between the two groups were detected for postoperative consumption of tramadol, pain score (NRS), intensity of nausea (NRS), presence of vomiting, consumption of rescue analgesics and antiemetics, and patient satisfaction.
","[{'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Bilgen', 'Affiliation': 'Acibadem Kozyataği Hospital, Department of Anesthesiology, Ondokuz Mayıs Mah, Begonya Sokak, No. 12, Kadıköy, İstanbul, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Erdoğan Ari', 'Affiliation': 'Acibadem Kozyataği Hospital, Department of Anesthesiology, Ondokuz Mayıs Mah, Begonya Sokak, No. 12, Kadıköy, İstanbul, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Özveri', 'Affiliation': 'Acibadem Kozyataği Hospital, Department of General Surgery, Ondokuz Mayıs Mah, Begonya Sokak, No. 12, Kadıköy, İstanbul, Turkey.'}]",International journal of clinical practice,['10.1155/2022/7387600']
1519,35685535,"Sesame Oil Ameliorates Alanine Aminotransferase, Aspartate Aminotransferase, and Fatty Liver Grade in Women with Nonalcoholic Fatty Liver Disease Undergoing Low-Calorie Diet: A Randomized Double-Blind Controlled Trial.","Background


The type and amount of dietary fats play an important role in fat accumulation in the liver. Sesame oil (SO) is a good source of monounsaturated acids (MUFAs) and polyunsaturated fatty acids (PUFAs).
Objective


This trial aimed at examining the effect of SO consumption on the levels of liver enzymes and the severity of fatty liver in women with nonalcoholic fatty liver disease (NAFLD) undergoing a weight loss diet.
Methods


This randomized, double-blind, controlled trial was carried out on 60 women with NAFLD. Subjects were randomly assigned to the SO group ( n  = 30) and sunflower oil (SFO) group ( n  = 30), each person consuming 30 grams of oil per day for 12 weeks. All the participants received a hypocaloric diet (-500 kcal/day) during the study. Fatty liver grade and liver enzymes were assessed at pre- and postintervention phases.
Results


53 patients completed the study. Significant reductions in body weight, body mass index (BMI), waist circumference (WC), and fatty liver grade were observed in both groups ( P  < 0.05). Following SO, significant decreases in serum aspartate and alanine aminotransferases (AST and ALT) were observed. After adjusting for confounders, ALT, AST, and fatty liver grade of the SO group were significantly reduced compared to the SFO group ( P  < 0.05). However, the changes in serum alkaline phosphatase (ALP) were not significant ( P  > 0.05).
Conclusions


The desired effects of weight loss were reinforced by the consumption of SO through improving fatty liver severity and serum ALT and AST levels in NAFLD patients. Moreover, low-calorie diets may lead to favorable outcomes for NAFLD patients through mitigation of obesity and fatty liver grade.",2022,"Significant reductions in body weight, body mass index (BMI), waist circumference (WC), and fatty liver grade were observed in both groups ( P  < 0.05).","['Women with Nonalcoholic Fatty Liver Disease Undergoing Low-Calorie Diet', 'women with nonalcoholic fatty liver disease (NAFLD) undergoing a weight loss diet', '60 women with NAFLD', '53 patients completed the study']","['SO consumption', 'SFO', 'Sesame oil (SO', 'hypocaloric diet', 'sunflower oil (SFO']","['weight loss', 'Fatty liver grade and liver enzymes', 'serum aspartate and alanine aminotransferases (AST and ALT', 'body weight, body mass index (BMI), waist circumference (WC), and fatty liver grade', 'serum alkaline phosphatase (ALP', 'Sesame Oil Ameliorates Alanine Aminotransferase, Aspartate Aminotransferase, and Fatty Liver Grade', 'fatty liver severity and serum ALT and AST levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036845', 'cui_str': 'Sesame Oil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0036845', 'cui_str': 'Sesame Oil'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.225282,"Significant reductions in body weight, body mass index (BMI), waist circumference (WC), and fatty liver grade were observed in both groups ( P  < 0.05).","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Atefi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Entezari', 'Affiliation': 'Food Security Research Centre and Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Vahedi', 'Affiliation': 'Department of Gastroenterology, School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hassanzadeh', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",International journal of clinical practice,['10.1155/2022/4982080']
1520,35685492,Effects of a Mediterranean Diet Compared with the Low-Fat Diet on Patients with Knee Osteoarthritis: A Randomized Feeding Trial.,"Objectives


Knee osteoarthritis is a common global problem, especially in overweight and obese people. It is not clear that weight loss is a factor for pain reduction in these patients or dietary components are important. Herein, we compared the effects of Mediterranean (MD) and low-fat diet on pain, stiffness, and physical function in patients with knee osteoarthritis.
Subjects


/.
Methods


In this randomized feeding trial, 129 patients with knee osteoarthritis were enrolled. Participants were randomly allocated to the MD ( n  = 43), low-fat diet ( n  = 43), and control group (regular diet) ( n  = 43) for 12 weeks by the blocked randomization method. Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score and its subscales and anthropometric indices were compared among the groups at the baseline and end of the study.
Results


Weight and waist circumference reduction was significantly higher in the MD and low-fat diet groups compared with the regular group ( p  < 0.001 and  p  < 0.001, respectively), but there was no significant difference between the MD and low-fat diet groups ( p  = 0.2). Pain was significantly decreased in the Mediterranean-style compared with the low-fat ( p  = 0.04) and regular ( p  = 0.002) diet groups. Physical function was significantly improved in the MD compared with the regular diet group ( p  = 0.01), but had no significant difference with the low-fat one. Stiffness had no significant difference among the dietary groups.
Conclusions


Pain severity was reduced in the MD group, but no significant change was reported in patients on low-fat and regular diets. It seems that dietary components in the MD, regardless of weight loss effect, are effective on pain reduction in patients with KOA. The present study was registered in the IRCT under the code of IRCT20200929048876N1.",2022,"Results


Weight and waist circumference reduction was significantly higher in the MD and low-fat diet groups compared with the regular group ( p  < 0.001 and  ","['129 patients with knee osteoarthritis were enrolled', 'patients with knee osteoarthritis', 'Patients with Knee Osteoarthritis', 'overweight and obese people', 'Subjects\n\n\n', 'patients with KOA']","['Low-Fat Diet', 'low-fat diet ( n \u2009=\u200943), and control group (regular diet', 'Mediterranean (MD) and low-fat diet', 'Mediterranean Diet']","['Weight and waist circumference reduction', 'pain, stiffness, and physical function', 'Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score and its subscales and anthropometric indices', 'Physical function', 'Conclusions\n\n\nPain severity', 'pain reduction', 'Pain']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",129.0,0.0155706,"Results


Weight and waist circumference reduction was significantly higher in the MD and low-fat diet groups compared with the regular group ( p  < 0.001 and  ","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Internal Medicine, Vali-e Asr Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Zarrinjooiee', 'Affiliation': 'Department of Internal Medicine, Vali-e Asr Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Seyedeh Neda', 'Initials': 'SN', 'LastName': 'Mousavi', 'Affiliation': 'Zanjan Metaboilc Diseases Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Somayae', 'Initials': 'S', 'LastName': 'Abdollahi Sabet', 'Affiliation': 'Department of Community Medicine, School of Medicine, Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Jalili', 'Affiliation': 'Department of Internal Medicine, Vali-e Asr Hospital, Zanjan University of Medical Science, Zanjan, Iran.'}]",International journal of clinical practice,['10.1155/2022/7275192']
1521,35685488,A Novel Risk-Prediction Scoring System for Sepsis among Patients with Acute Pancreatitis: A Retrospective Analysis of a Large Clinical Database.,"Background


The prognosis is poor when acute pancreatitis (AP) progresses to sepsis; therefore, it is necessary to accurately predict the probability of sepsis and develop a personalized treatment plan to reduce the disease burden of AP patients.
Methods


A total of 1295 patients with AP and 43 variables were extracted from the Medical Information Mart for Intensive Care (MIMIC) IV database. The included patients were randomly assigned to the training set and to the validation set at a ratio of 7 : 3. The chi-square test or Fisher's exact test was used to test the distribution of categorical variables, and Student's  t -test was used for continuous variables. Multivariate logistic regression was used to establish a prognostic model for predicting the occurrence of sepsis in AP patients. The indicators to verify the overall performance of the model included the area under the receiver operating characteristic curve (AUC), calibration curves, the net reclassification improvement (NRI), the integrated discrimination improvement (IDI), and a decision curve analysis (DCA).
Results


The multifactor analysis results showed that temperature, phosphate, calcium, lactate, the mean blood pressure (MBP), urinary output, Glasgow Coma Scale (GCS), Charlson Comorbidity Index (CCI), sodium, platelet count, and albumin were independent risk factors. All of the indicators proved that the prediction performance and clinical profitability of the newly established nomogram were better than those of other common indicators (including SIRS, BISAP, SOFA, and qSOFA).
Conclusions


The new risk-prediction system that was established in this research can accurately predict the probability of sepsis in patients with acute pancreatitis, and this helps clinicians formulate personalized treatment plans for patients. The new model can reduce the disease burden of patients and can contribute to the reasonable allocation of medical resources, which is significant for tertiary prevention.",2022,"All of the indicators proved that the prediction performance and clinical profitability of the newly established nomogram were better than those of other common indicators (including SIRS, BISAP, SOFA, and qSOFA).
","['1295 patients with AP and 43 variables were extracted from the Medical Information Mart for Intensive Care (MIMIC', 'Patients with Acute Pancreatitis', 'patients with acute pancreatitis']",[],"['receiver operating characteristic curve (AUC), calibration curves, the net reclassification improvement (NRI), the integrated discrimination improvement (IDI), and a decision curve analysis (DCA', 'prediction performance and clinical profitability', 'temperature, phosphate, calcium, lactate, the mean blood pressure (MBP), urinary output, Glasgow Coma Scale (GCS), Charlson Comorbidity Index (CCI), sodium, platelet count, and albumin']","[{'cui': 'C4517556', 'cui_str': '1295'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",[],"[{'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037501', 'cui_str': 'Sodium Dichloroacetate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]",1295.0,0.0642779,"All of the indicators proved that the prediction performance and clinical profitability of the newly established nomogram were better than those of other common indicators (including SIRS, BISAP, SOFA, and qSOFA).
","[{'ForeName': 'Aozi', 'Initials': 'A', 'LastName': 'Feng', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong 510632, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Ao', 'Affiliation': 'The Science & Education Office, The First Affiliated Hospital, Jinan University, Guangzhou, Guangdong 510632, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'College of Pharmacy, Henan University of Chinese Medicine, Zhengzhou, Henan 450046, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong 510632, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong 510632, China.'}, {'ForeName': 'Mengnan', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'College of Pharmacy, Henan University of Chinese Medicine, Zhengzhou, Henan 450046, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong 510632, China.'}]",International journal of clinical practice,['10.1155/2022/5435656']
1522,35685430,COlchicine to Prevent PeriprocEdural Myocardial Injury in Percutaneous Coronary Intervention (COPE-PCI): Coronary Microvascular Physiology Pilot Substudy.,"Aim


In this randomized pilot trial, we aimed to assess the anti-inflammatory effect of preprocedural colchicine on coronary microvascular physiology measurements before and after PCI.
Methods


Patients undergoing PCI for stable angina (SA) or non-ST-elevation myocardial infarction (NSTEMI) were randomized to oral colchicine or placebo, 6- to 24-hours before the procedure. Strict prespecified inclusion/exclusion criteria were set to ensure all patients were given the study medication, had a PCI, and had pre- and post-PCI culprit vessel invasive coronary physiology measurements. Fractional flow reserve (FFR), Index of Microvascular Resistance (IMR), Coronary Flow Reserve (CFR), and Resistive Reserve Ratio (RRR) were measured immediately before and after PCI. CMVD was defined as any one of post-PCI IMR >32 or CFR <2 or RRR <2. High-sensitive-(hs)-troponin-I, hsCRP, and leucocyte count were measured before and 24 hours after PCI.
Results


A total of 50 patients were randomized and met the strict prespecified inclusion/exclusion criteria: 24-colchicine and 26-placebo. Pre-PCI coronary physiology measurements, hs-troponin-I, and hsCRP were similar between groups. Although numerically lower in patients given colchicine, the proportion of patients who developed CMVD was not significantly different between groups (colchicine: 10 (42%) vs placebo: 16 (62%),  p =0.16). Colchicine patients had higher post-PCI CFR and RRR vs placebo (respectively: 3.25 vs 2.00,  p =0.03 & 4.25 vs 2.75,  p  < 0.01). Neutrophil count was lower after PCI in the colchicine arm ( p =0.02), and hsCRP post-PCI remained low in both treatment arms (1.0 mg/L vs 1.7 mg/L,  p =0.97). Patients randomized to colchicine had significantly less PCI-related absolute hs-troponin-I change (46 ng/L vs 152 ng/L,  p =0.01).
Conclusion


In this pilot randomized substudy, colchicine given 6 to 24 hours before PCI did not statistically impact the post-PCI CMVD definition used in this study, yet it did improve post-PCI RRR and CFR measurements, with less procedure-related troponin release and less inflammation.",2022,"Neutrophil count was lower after PCI in the colchicine arm ( p =0.02), and hsCRP post-PCI remained low in both treatment arms (1.0 mg/L vs 1.7 mg/L,  p =0.97).","['50 patients were randomized and met the strict prespecified inclusion/exclusion criteria', 'Patients undergoing PCI for stable angina (SA) or non-ST-elevation myocardial infarction (NSTEMI']","['24-colchicine and 26-placebo. Pre-PCI coronary physiology measurements, hs-troponin', 'colchicine', 'Colchicine', 'High-sensitive-(hs)-troponin', 'preprocedural colchicine', 'COlchicine', 'colchicine or placebo', 'placebo']","['PCI-related absolute hs-troponin-I change', 'I, hsCRP, and leucocyte count', 'CMVD', 'Neutrophil count', 'coronary microvascular physiology measurements', 'Fractional flow reserve (FFR), Index of Microvascular Resistance (IMR), Coronary Flow Reserve (CFR), and Resistive Reserve Ratio (RRR', 'higher post-PCI CFR and RRR', 'post-PCI RRR and CFR measurements', 'PeriprocEdural Myocardial Injury', 'hsCRP post-PCI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C1276061', 'cui_str': 'Acute non-ST segment elevation myocardial infarction'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0772289', 'cui_str': 'corticotropin-releasing factor, human'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",50.0,0.0596851,"Neutrophil count was lower after PCI in the colchicine arm ( p =0.02), and hsCRP post-PCI remained low in both treatment arms (1.0 mg/L vs 1.7 mg/L,  p =0.97).","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Peninsula Heart Service, Peninsula Health, Frankston, Australia.'}, {'ForeName': 'Nay', 'Initials': 'N', 'LastName': 'Htun', 'Affiliation': 'Peninsula Heart Service, Peninsula Health, Frankston, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lew', 'Affiliation': 'Peninsula Heart Service, Peninsula Health, Frankston, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Freilich', 'Affiliation': 'Peninsula Heart Service, Peninsula Health, Frankston, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Quinn', 'Affiliation': 'Department of Health Science and Biostatistics, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Layland', 'Affiliation': 'Peninsula Heart Service, Peninsula Health, Frankston, Australia.'}]",Journal of interventional cardiology,['10.1155/2022/1098429']
1523,35685671,A Case-Control Study of Continuous Veno-Venous Hemofiltration Combined with Xuebijing Injection in the Treatment of Severe Sepsis.,"A case-control study was conducted to evaluate the efficacy of continuous veno-venous hemofiltration (CVVH) combined with Xuebijing in the treatment of severe sepsis. In order to verify this claim, this study included 100 patients with severe sepsis treated in our hospital from February 2019 to April 2021. The patients were randomly divided into control group and study group. The control group was treated with CVVH, and the study group was treated with CVVH combined with Xuebijing. The curative effect and mortality, NT-proBNP, PCT, Ca∼_(2+), white blood cell count, neutrophil ratio, blood gas analysis, and APACHE-II score were compared between the two groups. The total effective rate of the study group was better than that of the control group ( P  < 0.05). The fatality rate in the study group was lower than that in the control group ( P  < 0.05). The levels of NT-proBNP and PCT in the study group were lower than those in the control group, while the level of serum calcium in the study group was higher than that in the control group. After treatment, the white blood cell count (WBC) and neutrophil count in the study group were (13.76 ± 1.28) × 109 shock L and (73.48 ± 1.23)%, respectively, which were significantly lower than those in the control group (17.45 ± 1.36) × 109 shock L and (77.82 ± 1.44)% ( P  < 0.05). After treatment, the levels of APTT, PT, and DD in the study group were lower than those in the control group. The level of FIB in the study group was significantly higher than that in the control group after treatment. After treatment, the PaO 2  and PaO 2 /FiO 2  of the study group were higher than those of the control group, and the APACHE-II score of the study group was lower than that of the control group. CVVH combined with Xuebijing is of positive significance in the treatment of severe sepsis and is worth popularizing.",2022,The fatality rate in the study group was lower than that in the control group ( P  < 0.05).,"['Severe Sepsis', 'severe sepsis', '100 patients with severe sepsis treated in our hospital from February 2019 to April 2021']","['CVVH', 'continuous veno-venous hemofiltration (CVVH) combined with Xuebijing', 'CVVH combined with Xuebijing', 'Continuous Veno-Venous Hemofiltration Combined with Xuebijing Injection']","['total effective rate', 'levels of APTT, PT, and DD', 'level of serum calcium', 'curative effect and mortality, NT-proBNP, PCT, Ca∼_(2+), white blood cell count, neutrophil ratio, blood gas analysis, and APACHE-II score', 'levels of NT-proBNP and PCT', 'white blood cell count (WBC) and neutrophil count', 'fatality rate', 'level of FIB']","[{'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0472684', 'cui_str': 'Continuous venovenous hemofiltration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2933944', 'cui_str': 'Xuebijing'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0032452', 'cui_str': 'Polychlorotriphenyl Compounds'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}]",100.0,0.0463372,The fatality rate in the study group was lower than that in the control group ( P  < 0.05).,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Intensive Care Unit, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University, 269 University Road, Xuzhou 221000, Jiangsu, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Lianyungang, 182 Tongguan Road, Lianyungang 222000, Jiangsu, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Lianyungang, 182 Tongguan Road, Lianyungang 222000, Jiangsu, China.""}, {'ForeName': 'Yuliang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Intensive Care Unit, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University, 269 University Road, Xuzhou 221000, Jiangsu, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University, 269 University Road, Xuzhou 221000, Jiangsu, China.'}]",Contrast media & molecular imaging,['10.1155/2022/7884508']
1524,35685664,Artificial Intelligence Algorithm-Based High-Resolution Computed Tomography Image in the Treatment of Children with Bronchiolitis Obliterans by Traditional Chinese Medicine Method of Resolving Phlegm and Removing Blood Stasis.,"This research was aimed to explore the application of high-resolution computed tomography (HRCT) based on intelligent iterative reconstruction technique in the early diagnosis and treatment of bronchiolitis obliterans (BO) in children and to explore the efficacy of traditional Chinese medicine (TCM) in resolving phlegm and removing blood stasis. Sixty pediatric patients with BO were selected as the study subjects and diagnosed by HRCT scanning, and the scanned images were processed by iterative reconstruction technique. The patients were treated with TCM therapy of resolving phlegm and removing blood stasis alone (group A), HRCT-guided TCM therapy of resolving phlegm and removing blood stasis (group B), and iterative reconstruction HRCT-guided TCM therapy of resolving phlegm and removing blood stasis (group C). The results showed that the lung HRCT image after iterative reconstruction was closer to the original image than that after filtered back projection reconstruction, and the edge of the image after filtered back projection reconstruction was more blurred and the noise was higher. The image obtained by iterative reconstruction technique was smoother and clearer, and the image stability after iterative reconstruction was higher. The treatment results showed that the proportion of moderate and severe obstruction in group C was 5.18%, which was significantly lower than that in group A (18.75%) and group B (11.29%), and group B was significantly lower than that in group A (18.75%) ( P  < 0.05). The proportion of clinical effect in group C after treatment was 70.18%, significantly higher than that in group A (55.5%) and group B (63.34%), and that in group B was significantly higher than that in group A (55.5%) ( P  < 0.05). In summary, the lung HRCT after iterative reconstruction can more clearly and intuitively show the lesion site, which has a key role in guiding the early diagnosis and treatment planning of BO; the HRCT image based on iterative reconstruction technique combined with TCM treatment of removing blood stasis and resolving phlegm has a better therapeutic effect on children, with a high application value.",2022,"The proportion of clinical effect in group C after treatment was 70.18%, significantly higher than that in group A (55.5%) and group B (63.34%), and that in group B was significantly higher than that in group A (55.5%) ( P  < 0.05).","['Sixty pediatric patients with BO', 'Children with Bronchiolitis Obliterans', 'bronchiolitis obliterans (BO) in children']","['HRCT-guided TCM therapy of resolving phlegm and removing blood stasis (group B), and iterative reconstruction HRCT-guided TCM therapy of resolving phlegm and removing blood stasis', 'Artificial Intelligence Algorithm-Based High-Resolution Computed Tomography Image', 'high-resolution computed tomography (HRCT', 'TCM therapy of resolving phlegm and removing blood stasis alone', 'traditional Chinese medicine (TCM']","['proportion of clinical effect', 'proportion of moderate and severe obstruction']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006272', 'cui_str': 'Obliterative bronchiolitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",60.0,0.0175443,"The proportion of clinical effect in group C after treatment was 70.18%, significantly higher than that in group A (55.5%) and group B (63.34%), and that in group B was significantly higher than that in group A (55.5%) ( P  < 0.05).","[{'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Child Health Section, Hunan Province Directly Affiliated TCM Hospital, Zhuzhou, Hunan 412000, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics and Traumatology, Zhuzhou 331 Hospital, Zhuzhou, Hunan 412000, China.'}]",Contrast media & molecular imaging,['10.1155/2022/8952791']
1525,35685661,Effect of Berberine Hydrochloride on the Diversity of Intestinal Flora in Parkinson's Disease Patients.,"This study aimed to investigate the effect of berberine hydrochloride on the diversity of intestinal flora in patients with Parkinson's disease (PD). Prospectively selected 68 PD patients, admitted to our hospital from April 2021 to June 2021, were randomly assigned to an observation group and a control group ( n  = 34 per group). Patients in the control group were given conventional treatment in accordance with Parkinson's diagnosis and treatment guidelines. Patients in the observation group were administered berberine hydrochloride besides the treatment in the control group. After continuous treatment for 3 months, the enzyme-linked immunosorbent assay was applied to determine interleukin-8 (IL-8), interleukin-6 (IL-6), and tumor necrosis factor- α  (TNF- α ) levels. High-throughput sequencing technology was employed to perform DNA sequencing on the 16S rRNA genes of all bacteria in stool samples before and after treatment in the two groups to analyze the distribution of intestinal flora. After treatment, the levels of IL-8, IL-6, and TNF- α  were lower in the observation group than those in the control group ( P  < 0.05). Regarding intestinal flora, the Chao index, Ace index, and Shannon index were higher in the observation group than those in the control group. The Simpson index was lower in the observation group than that of the control group ( P  < 0.05). The principal component analysis chart analysis exhibited that the overall structure of the intestinal flora was quite different between the observation and the control groups after treatment. Berberine hydrochloride can improve the disorder of intestinal flora in PD patients and suppress the expression of inflammatory factors.",2022,"After treatment, the levels of IL-8, IL-6, and TNF- α  were lower in the observation group than those in the control group ( P  < 0.05).","[""Parkinson's Disease Patients"", '68 PD patients, admitted to our hospital from April 2021 to June 2021', ""patients with Parkinson's disease (PD""]","['Berberine Hydrochloride', 'berberine hydrochloride', 'conventional treatment', 'Berberine hydrochloride']","['Chao index, Ace index, and Shannon index', 'interleukin-8 (IL-8), interleukin-6 (IL-6), and tumor necrosis factor- α  (TNF- α ) levels', 'Diversity of Intestinal Flora', 'levels of IL-8, IL-6, and TNF- α', 'Simpson index']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0873019', 'cui_str': 'Berberine hydrochloride'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.0786041,"After treatment, the levels of IL-8, IL-6, and TNF- α  were lower in the observation group than those in the control group ( P  < 0.05).","[{'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""The First People's Hospital of Lianyungang, The First Affiliated Hospital of KangDA College of Nanjing Medical University, Lianyungang 222000, Jiangsu Province, China.""}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Meng', 'Affiliation': ""The First People's Hospital of Lianyungang, The First Affiliated Hospital of KangDA College of Nanjing Medical University, Lianyungang 222000, Jiangsu Province, China.""}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""The First People's Hospital of Lianyungang, The First Affiliated Hospital of KangDA College of Nanjing Medical University, Lianyungang 222000, Jiangsu Province, China.""}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'He', 'Affiliation': ""The First People's Hospital of Lianyungang, The First Affiliated Hospital of KangDA College of Nanjing Medical University, Lianyungang 222000, Jiangsu Province, China.""}]",Contrast media & molecular imaging,['10.1155/2022/8381870']
1526,35685657,Efficacy and Safety of Botulinum Toxin A and Pulsed Radiofrequency on Postherpetic Neuralgia: A Randomized Clinical Trial.,"This study evaluated the effectiveness and safety of botulinum toxin type A (BoNT-A) and pulsed radiofrequency (RF) in the clinical treatment of postherpetic neuralgia (PHN). A total of 100 patients with PHN were randomly divided into two groups ( n  = 50 per group): RF group and BoNT-A group. Based on conventional drug treatment, patients were treated with either a single nerve root pulsed radiofrequency therapy or a single local subcutaneous injection of BoNT-A in the lesion area. All the patients were followed up for 24 weeks on pain scores, sleep quality, anxiety, and depression scores, etc. In the last follow-up at the end of 24 weeks postoperation, the pain scores of patients in both groups were significantly lower than those before the operation ( P  < 0.05), indicating that both treatments were effective against PHN; however, there was no significant difference between these two groups ( P  > 0.05). It is noteworthy that the subcutaneous injection of BoNT-A is relatively easy to administer and less expensive compared to RF. Therefore, we believe that the subcutaneous injection of BoNT-A is an effective and safe method for the treatment of PHN.",2022,"In the last follow-up at the end of 24 weeks postoperation, the pain scores of patients in both groups were significantly lower than those before the operation ( P  < 0.05), indicating that both treatments were effective against PHN; however, there was no significant difference between these two groups ( P  > 0.05).","['postherpetic neuralgia (PHN', 'Postherpetic Neuralgia', '100 patients with PHN']","['single nerve root pulsed radiofrequency therapy', 'botulinum toxin type A (BoNT-A) and pulsed radiofrequency (RF', 'Botulinum Toxin A and Pulsed Radiofrequency']","['pain scores, sleep quality, anxiety, and depression scores, etc', 'pain scores', 'Efficacy and Safety']","[{'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C4704842', 'cui_str': 'Radio-Frequency Therapy'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.0343324,"In the last follow-up at the end of 24 weeks postoperation, the pain scores of patients in both groups were significantly lower than those before the operation ( P  < 0.05), indicating that both treatments were effective against PHN; however, there was no significant difference between these two groups ( P  > 0.05).","[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Soochow University Department of Anesthesiology, Suzhou 215006, Jiangsu, China.'}, {'ForeName': 'Yaoyao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Xuzhou Medical University Institute of Anesthesia, Xuzhou 221000, Jiangsu, China.'}, {'ForeName': 'Yanru', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Xuzhou Medical University Institute of Anesthesia, Xuzhou 221000, Jiangsu, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'The Second Affiliated Hospital of Xuzhou Medical University Department of Pain, Xuzhou 221002, Jiangsu, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'The Affiliated Hospital of Xuzhou Medical University Department of Pain, Xuzhou 221000, Jiangsu, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'The Affiliated Hospital of Xuzhou Medical University Department of Pain, Xuzhou 221000, Jiangsu, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'The Affiliated Hospital of Xuzhou Medical University Department of Pain, Xuzhou 221000, Jiangsu, China.'}, {'ForeName': 'Fuhai', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'The First Affiliated Hospital of Soochow University Department of Anesthesiology, Suzhou 215006, Jiangsu, China.'}]",Contrast media & molecular imaging,['10.1155/2022/1579937']
1527,35690797,"Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial.","BACKGROUND


Cognitive problems affect up to 70% of people with multiple sclerosis (MS), which can negatively impact mood, ability to work, and quality of life. Addressing cognitive problems is a top 10 research priority for people with MS. Our ongoing research has systematically developed a cognitive screening and management pathway (NEuRoMS) tailored for people with MS, involving a brief cognitive evaluation and rehabilitation intervention. The present study aims to assess the feasibility of delivering the pathway and will inform the design of a definitive randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of the intervention and eventually guide its clinical implementation.
METHODS


The feasibility study is in three parts. Part 1 involves an observational study of those who receive screening and support for cognitive problems, using routinely collected clinical data. Part 2 is a two-arm, parallel group, multicentre, feasibility RCT with a nested fidelity evaluation. This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60). In part 3, semi-structured interviews will be undertaken with participants from part 2 (n = 25), clinicians (n = 9), and intervention providers (n = 3) involved in delivering the NEuRoMS cognitive screening and management pathway. MS participants will be recruited from outpatient clinics at three UK National Health Service hospitals.
DISCUSSION


Timely screening and effective management of cognitive problems in MS are urgently needed due to the detrimental consequences of cognitive problems on people with MS, the healthcare system, and wider society. The NEuRoMS intervention is based on previous and extant literature and has been co-constructed with relevant stakeholders. If effective, the NEuRoMS pathway will facilitate timely identification and management of cognitive problems in people with MS.
TRIAL REGISTRATION


ISRCTN11203922 . Prospectively registered on 09.02.2021.",2022,"This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60).","['MS participants will be recruited from outpatient clinics at three UK National Health Service hospitals', 'people with multiple sclerosis (MS', 'people with MS', 'multiple sclerosis (NEuRoMS', 'people with MS with mild cognitive problems (n = 60']","['NEuRoMS cognitive screening and management pathway', 'NEuRoMS intervention', 'NEuRoMS intervention plus usual care']",[],"[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.033306,"This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60).","[{'ForeName': 'Gogem', 'Initials': 'G', 'LastName': 'Topcu', 'Affiliation': 'Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'School of Psychology, Keynes College, University of Kent, Canterbury, Kent, UK.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Mhizha-Murira', 'Affiliation': 'Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nia', 'Initials': 'N', 'LastName': 'Goulden', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health Clinical Trials Unit, Bangor University, Bangor, UK.'}, {'ForeName': 'Zoë', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health Clinical Trials Unit, Bangor University, Bangor, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fitzsimmons', 'Affiliation': 'Swansea Centre for Health Economics, School of Health and Social Care, Faculty of Medicine, Health and Life Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Evangelou', 'Affiliation': 'Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schmierer', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Barts and the London School of Medicine and Dentistry, The Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Tallantyre', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leighton', 'Affiliation': 'Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Allen-Philbey', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Barts and the London School of Medicine and Dentistry, The Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Stennett', 'Affiliation': 'Wolfson Institute of Population Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bradley', 'Affiliation': 'Department of Neurology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Bale', 'Affiliation': 'Multiple Sclerosis Patient and Public Involvement Group, Nottingham, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Turton', 'Affiliation': 'Multiple Sclerosis Patient and Public Involvement Group, Nottingham, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'das Nair', 'Affiliation': 'Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK. roshan.dasnair@nottingham.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pilot and feasibility studies,['10.1186/s40814-022-01073-5']
1528,35690783,Factors associated with the health-related quality of life among people with Duchenne muscular dystrophy: a study using the Health Utilities Index (HUI).,"BACKGROUND


Data on health state utility in Duchenne muscular dystrophy (DMD) are few. This study estimated mean utility values by age, ambulatory status and over time, and investigated which aspects of health-related quality-of-life (HRQoL) are most strongly associated with utility in DMD.
METHODS


Data from placebo-treated ambulant boys with DMD with exon 51 skip amenable mutations, (NCT01254019), were included. Ambulatory function assessments were conducted at baseline and every 12 weeks for the trial duration. Family member proxies completed the Health Utility Index (HUI) at baseline, 24 and 48 weeks; and HUI3 and HUI2 utility values were summarized. Changes in HUI attribute level over time, and predictors of changes in utility, were explored.
RESULTS


Sixty-one boys (mean [range] age of 8.0 [5-16] years) were included in the analysis. Mean baseline utilities were 0.82 (HUI3) and 0.87 (HUI2); and utilities were 0.35 (HUI3) and 0.55 (HUI2) after loss of ambulation (LOA, where applicable). Over the follow-up period mean utility declined more among the older versus younger boys. Pain accounted for the highest proportion of variability (42%) in change in HUI3 utility from baseline to week 48, while for HUI2, self-care (39%) did. After LOA, change in ambulation levels explained 88% of the decline in mean HUI3 utility and change in mobility levels explained 66% of the decline in mean HUI2 utility.
CONCLUSIONS


Utility values among this sample were higher than previously published estimates. In younger boys utility remained relatively stable, but older boys and those losing ambulation experienced important declines over follow-up.",2022,"Pain accounted for the highest proportion of variability (42%) in change in HUI3 utility from baseline to week 48, while for HUI2, self-care (39%) did.","['people with Duchenne muscular dystrophy', 'treated ambulant boys with DMD with exon 51 skip amenable mutations, (NCT01254019), were included', 'Sixty-one boys (mean [range] age of 8.0 [5-16] years) were included in the analysis']",['placebo'],"['ambulation levels', 'Mean baseline utilities', 'Health Utility Index (HUI', 'mean HUI3 utility and change in mobility levels', 'Pain', 'HUI3 and HUI2 utility values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.144251,"Pain accounted for the highest proportion of variability (42%) in change in HUI3 utility from baseline to week 48, while for HUI2, self-care (39%) did.","[{'ForeName': 'Shelagh M', 'Initials': 'SM', 'LastName': 'Szabo', 'Affiliation': 'Broadstreet HEOR, 201 - 343 Railway St, Vancouver, BC, Canada. sszabo@broadstreetheor.com.'}, {'ForeName': 'Ivana F', 'Initials': 'IF', 'LastName': 'Audhya', 'Affiliation': 'Sarepta Therapeutics, 215 First St, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Basia', 'Initials': 'B', 'LastName': 'Rogula', 'Affiliation': 'Broadstreet HEOR, 201 - 343 Railway St, Vancouver, BC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feeny', 'Affiliation': 'McMaster University and Health Utilities Inc., Hamilton, ON, Canada.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Gooch', 'Affiliation': 'Sarepta Therapeutics, 215 First St, Cambridge, MA, 02142, USA.'}]",Health and quality of life outcomes,['10.1186/s12955-022-02001-0']
1529,35690773,Efficacy and safety of radiotherapy plus anti-PD1 versus transcatheter arterial chemoembolization plus sorafenib for advanced hepatocellular carcinoma: a real-world study.,"BACKGROUND


The combination of transcatheter arterial chemoembolization (TACE) plus sorafenib prolonged progression-free survival (PFS) and overall survival (OS) than sorafenib or TACE monotherapy for patients with hepatocellular carcinoma (HCC). This study assessed the efficacy and safety of radiotherapy (RT) plus monoclonal antibody against programmed cell death 1 (anti-PD1) versus TACE plus sorafenib for patients with advanced HCC.
METHODS


Patients with advanced HCC who treated with RT plus anti-PD1 and TACE plus sorafenib were enrolled. Objective response rate (ORR), PFS, disease control rate (DCR) and OS were calculated to assess the antitumor response and the treatment-related adverse events to the safety.
RESULTS


Between January 2018 to March 2021, 37 patients underwent RT plus anti-PD1 and 41 patients underwent TACE plus sorafenib. The baseline characteristics between the two groups were comparable. The ORR and DCR were significantly higher in the RT + PD1 group than the TACE plus sorafenib group according to RECIST 1.1 (54.05% vs. 12.20%, P < 0.001; 70.27% vs. 46.37%, P = 0.041; respectively) and according to mRECIST (56.76% vs. 31.71%, P = 0.039; 70.27% vs. 46.37%, P = 0.041; respectively). RT plus anti-PD1 provided significantly better PFS (HR, 0.51; 95% CI 0.30-0.86; P = 0.017) than TACE plus sorafenib. Moreover, patients with RT plus anti-PD1 had significantly higher 3-, 6-, and 9-month OS rates than those with TACE plus sorafenib(97.3% vs. 92.30%, P < 0.001; 91.89% vs. 68.60%, P < 0.001; 75.5% vs. 60.60%, P < 0.001; respectively). The median OS was more favorable 17.4 months for the RT + PD1 group and 11.9 months for the TACE plus sorafenib group. No treatment-related death was observed. Grade 3 or more treatment-related adverse events (TRAEs) occurred significantly less in patients in the RT + PD1 group than the TACE plus sorafenib group (29.7% vs. 75.6%, P < 0.001), and all TRAEs were manageable.
CONCLUSIONS


In this real-world study, RT plus anti-PD1 showed significantly promising efficacy and manageable safety than TACE plus sorafenib in patients with advanced HCC. Toxicities were manageable, with no unexpected safety signals. The study provides evidence on a new therapeutic method in the treatment of advanced HCC.",2022,"Grade 3 or more treatment-related adverse events (TRAEs) occurred significantly less in patients in the RT + PD1 group than the TACE plus sorafenib group (29.7% vs. 75.6%, P < 0.001), and all TRAEs were manageable.
","['Patients with advanced HCC who treated with RT plus anti-PD1 and TACE plus sorafenib were enrolled', 'patients with advanced HCC', 'advanced hepatocellular carcinoma', 'patients with hepatocellular carcinoma (HCC', 'Between January 2018 to March 2021, 37 patients underwent']","['RT plus anti-PD1', 'radiotherapy (RT) plus monoclonal antibody', 'sorafenib or TACE monotherapy', 'transcatheter arterial chemoembolization (TACE) plus sorafenib', 'TACE plus sorafenib', 'radiotherapy plus anti-PD1 versus transcatheter arterial chemoembolization plus sorafenib']","['ORR and DCR', 'Toxicities', 'efficacy and manageable safety', 'efficacy and safety', 'Efficacy and safety', '9-month OS rates', 'median OS', 'progression-free survival (PFS) and overall survival (OS', 'Objective response rate (ORR), PFS, disease control rate (DCR) and OS', 'PFS', 'adverse events (TRAEs', 'death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0420773,"Grade 3 or more treatment-related adverse events (TRAEs) occurred significantly less in patients in the RT + PD1 group than the TACE plus sorafenib group (29.7% vs. 75.6%, P < 0.001), and all TRAEs were manageable.
","[{'ForeName': 'Jian-Xu', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Wen-Xiang', 'Initials': 'WX', 'LastName': 'Deng', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Shi-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Mei-Ying', 'Initials': 'MY', 'LastName': 'Long', 'Affiliation': 'School of Public Health, Guangxi Medical University, Nanning, 530021, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Ting-Shi', 'Initials': 'TS', 'LastName': 'Su', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Li-Qing', 'Initials': 'LQ', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Ya-Dan', 'Initials': 'YD', 'LastName': 'Pang', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Chun-Feng', 'Initials': 'CF', 'LastName': 'Liang', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Hong-Mei', 'Initials': 'HM', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Shi-Xiong', 'Initials': 'SX', 'LastName': 'Liang', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.'}, {'ForeName': 'Bang-De', 'Initials': 'BD', 'LastName': 'Xiang', 'Affiliation': 'Department of Hepatobiliary Surgery, Guangxi Medical University Cancer Hospital, Nanning, 530021, China. xiangbangde@gxmu.edu.cn.'}]","Radiation oncology (London, England)",['10.1186/s13014-022-02075-6']
1530,35691283,Initial eGFR Changes with Ertugliflozin and Associations with Clinical Parameters: Analyses from the VERTIS CV Trial.,"INTRODUCTION


Using data from the ertugliflozin cardiovascular outcomes trial in patients with type 2 diabetes mellitus (VERTIS CV; NCT01986881), associations between the initial estimated glomerular filtration rate (eGFR) ""dip"" with eGFR slope, glucosuria/natriuresis-related measures, and safety were investigated.
METHODS


Patients were categorized into tertiles based on change in eGFR at week 6: >+1.00 mL/min/1.73 m2 (tertile 1), >-5.99 and ≤+1.00 (tertile 2), and ≤-6.00 (tertile 3). eGFR slope after week 6 and week 18 was assessed by tertile. Glucosuria/natriuresis-related measures were also determined. Adverse events (AEs) were analyzed in the acute (baseline-week 6) and chronic periods (week 6-30 days after last dose of trial medication).
RESULTS


In the ertugliflozin group, chronic eGFR slopes (95% CI, mL/min/1.73 m2/year; weeks 6-156) were -0.76 (-1.03, -0.50), -0.29 (-0.51, -0.07), and -0.05 (-0.26, 0.17) in tertiles 1, 2, and 3, respectively (p value <0.001), and approximately -1.5 mL/min/1.73 m2/year across tertiles in the placebo group (p value = 0.79). At week 18, least squares mean (LSM) changes from baseline in glycated hemoglobin (%) were -0.77, -0.71, and -0.67 in tertiles 1, 2, and 3, respectively, in the ertugliflozin group; a similar tertile-associated trend was observed for uric acid. At week 18, LSM changes from baseline in hematocrit (%) were 2.07, 2.33, and 2.55 in tertiles 1, 2, and 3, respectively, in the ertugliflozin group; similar tertile-associated trends were observed for blood pressure. All pinteraction values were <0.0001 for glucosuria- and natriuresis-related measures. Kidney-related AEs were reported more frequently in tertiles 3 and 2 in the chronic period for both placebo- and ertugliflozin-treated groups. In both periods and in all tertiles, incidences of AEs did not differ between placebo- and ertugliflozin-treated groups.
CONCLUSION


With ertugliflozin, the tertile with the largest initial dip in eGFR had a slower rate of chronic eGFR decline. Initial eGFR changes were associated with changes in both glucosuria- and natriuresis-related measures.",2022,"In both periods and in all tertiles, incidences of AEs did not differ between placebo- and ertugliflozin-treated groups.
","['patients with type 2 diabetes mellitus', 'Patients were categorized into tertiles based on change in eGFR at week 6: >+1.00 mL/min/1.73 m2 (tertile 1), >-5.99 and ≤+1.00 (tertile 2), and ≤-6.00 (tertile 3']","['ertugliflozin', 'placebo']","['uric acid', 'glomerular filtration rate (eGFR) ""dip"" with eGFR slope, glucosuria/natriuresis-related measures, and safety', 'glycated hemoglobin', 'Initial eGFR changes', 'chronic eGFR slopes', 'Adverse events (AEs', 'eGFR slope', 'rate of chronic eGFR decline', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",156.0,0.170123,"In both periods and in all tertiles, incidences of AEs did not differ between placebo- and ertugliflozin-treated groups.
","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Unit of Cardiology, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Parkland Health and Hospital System, Dallas, Texas, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maldonado', 'Affiliation': 'MSD Limited, London, United Kingdom.'}, {'ForeName': 'Chih-Chin', 'Initials': 'CC', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Rahway, New Jersey, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Rahway, New Jersey, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000524889']
1531,35691282,Effects of Selenium and/or N-Acetyl-Cysteine Supplementation on Nonthyroidal Illness Syndrome in Hemodialysis Patients: A Factorial Randomized Controlled Trial.,"INTRODUCTION


Nonthyroidal illness syndrome (NTIS) is common in hemodialysis patients (HPs). However, limited clinical trials have been conducted in this field. Therefore, the aim of this study was to investigate the effect of Se and/or N-acetyl-cysteine (NAC) on NTIS parameters in HPs.
METHODS


In this factorial randomized controlled trial, 68 HPs were divided into four groups: group A received placebo of Se and NAC, group B received 600 μg per day of NAC and placebo of Se, group C received 200 μg of Se per day and placebo of NAC and group D received 200 μg of selenium and 600 μg of NAC per day for 12 weeks. Blood samples were taken at baseline and after 12 weeks to assess free tri-iodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), and reverse T3 (rT3) concentrations.
RESULTS


Our finding demonstrated that rT3 levels were decreased in B, C, and D groups and increased nearly to baseline levels in the A group after 12 weeks, with a marked difference between the groups (p < 0.001) based on ANOVA. Although there were no significant differences in FT3 (p = 0.39), FT4 (p = 0.76), and TSH (p = 0.71) between the groups at the end of the trial.
CONCLUSION


This trial showed that Se and/or NAC exert beneficial effects on rT3 levels in HPs. However, long-term clinical trials with a larger sample size using more appropriate biomarkers are recommended to evaluate the efficacy and safety of Se and/or NAC in HPs.",2022,"Although there were no significant differences in FT3 (p = 0.39), FT4 (p = 0.76), and TSH (p = 0.71) between the groups at the end of the trial.
","['Hemodialysis Patients', '68 HPs', 'HPs', 'hemodialysis patients (HPs']","['Selenium and/or N-Acetyl-Cysteine Supplementation', 'placebo of Se and NAC', 'Se and/or N-acetyl-cysteine (NAC', 'NAC and placebo of Se, group C received 200 μg of Se per day and placebo of NAC and group D received 200 μg of selenium and 600 μg of NAC']","['FT3', 'Nonthyroidal Illness Syndrome', 'rT3 levels', 'free tri-iodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), and reverse T3 (rT3) concentrations']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0202223', 'cui_str': 'T3 reverse measurement'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0202237', 'cui_str': 'Tri-iodothyronine measurement, total'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0041017', 'cui_str': 'Reverse T>3<'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",68.0,0.341856,"Although there were no significant differences in FT3 (p = 0.39), FT4 (p = 0.76), and TSH (p = 0.71) between the groups at the end of the trial.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shahreki', 'Affiliation': 'Department of Nephrology, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Mahmoud Ali', 'Initials': 'MA', 'LastName': 'Kaykhaei', 'Affiliation': 'Genetics of Noncomunicable Disease Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Adineh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Ali Mohammad', 'Initials': 'AM', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Social Development and Health Promotion Research Center, Gonabad University of Medical Sciences, Gonabad, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Hosseini', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Aliyeh', 'Initials': 'A', 'LastName': 'Bazi', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Zabol University of Medical Sciences, Zabol, Iran.'}]",Pharmacology,['10.1159/000525094']
1532,35691258,Efficacy of a standardized herbal product from Pistacia atlantica subsp. Kurdica in type 2 diabetic patients with hyperlipidemia: A triple-blind randomized clinical trial.,"BACKGROUND


Hyperlipidemia is one of the consequences of type 2 diabetes mellitus (T2DM) that puts the patients at the risk of getting cardiovascular disease. Pistacia atlantica subsp. Kurdica is used by local people for the improvement of lipid and glucose indices. This study was carried out to evaluate clinical effects of P. atlantica subsp. Kurdica on hyperlipidemia related to T2DM patients.
MATERIALS AND METHODS


In this randomized, triple-blind, and placebo-controlled study, type 2 diabetes patients with hyperlipidemia were randomly allocated to receive either P. atlantica kurdica or placebo capsule for 2 months. 58 Patients were followed up at the beginning and after the end of each month for assessment of lipid profiles, glucose indices, and liver and renal function tests. The herbal capsule was standardized according to volatile and nonvolatile compounds by GC-MS/FID and RP-HPLC-PDA, respectively. The total phenolic and flavonoid contents were also determined with a spectrophotometer.
RESULTS


After 1 and 2 months of the intervention period, mean differences of 2HPP, total cholesterol, and LDL-c have been reduced significantly (P < 0.05) between the two groups, but there were not reported any significant statistical changes in FBS, HbA1c, TG, HDL-c, ALT, AST, and Cr. The herbal capsule was standardized according to benzoic acid, ballic acid, rutin, and quercetin standard (6.5, 2.1, 1.4, 0.7 mg, respectively), and also α-pinene as major volatile constituent 28.51%.
CONCLUSION


According to results the P. atlantica kurdica is effective in the improvement of lipid profile and glucose indices in line with its local application.
CLINICAL TRIAL ID


(IRCT201708109014N178).",2022,"According to results the P. atlantica kurdica is effective in the improvement of lipid profile and glucose indices in line with its local application.
","['type 2 diabetes patients with hyperlipidemia', 'Kurdica on hyperlipidemia related to T2DM patients', 'type 2 diabetic patients with hyperlipidemia']","['P. atlantica kurdica or placebo capsule', 'placebo', 'standardized herbal product from Pistacia atlantica subsp']","['FBS, HbA1c, TG, HDL-c, ALT, AST, and Cr', 'total phenolic and flavonoid contents', '2HPP, total cholesterol, and LDL-c', 'lipid profiles, glucose indices, and liver and renal function tests', 'lipid profile and glucose indices']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0949836', 'cui_str': 'Pistacia'}]","[{'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",58.0,0.0448072,"According to results the P. atlantica kurdica is effective in the improvement of lipid profile and glucose indices in line with its local application.
","[{'ForeName': 'Faezeh Safari', 'Initials': 'FS', 'LastName': 'Majd', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyed Saman', 'Initials': 'SS', 'LastName': 'Talebi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Amir Nili', 'Initials': 'AN', 'LastName': 'Ahmad Abadi', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Poorolajal', 'Affiliation': 'Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Dastan', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: d.dastan@umsha.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2022.101613']
1533,35691250,Ovarian reserve in premenopausal women with breast cancer.,"BACKGROUND


As a special reproductive hormone and ovarian reserve indicator, the role of anti-Müllerian hormone (AMH) in premenopausal women with breast cancer deserves further study.
METHODS


We conducted an in-depth analysis of the data from the EGOFACT study (NCT02518191), a phase Ⅲ, randomized, controlled trial involving premenopausal female breast cancer patients in two parallel groups: chemotherapy with or without gonadotropin-releasing hormone analogs (GnRHa). Three hundred thirty premenopausal women aged 25-49 years with operable stage I to III breast cancer were included in this study. The characteristics of ovarian reserve changes marked by AMH in the EGOFACT study and the factors affecting ovarian function in premenopausal women with breast cancer were analyzed.
RESULTS


The AMH level of the chemotherapy alone group decreased gradually within one year, while the AMH level of the GnRHa group was significantly higher as early as 6 months after chemotherapy and recovered to close to the baseline level 12 months after chemotherapy (F = 34.991, P < 0.001). Correlation analysis showed that the factors affecting AMH levels mainly included age, menarche age, body mass index (BMI), reproductive history, baseline follicle stimulating hormone (FSH) level, pathological stage and GnRHa application, but they had different effects on the incidence of premature ovarian insufficiency (POI) at different periods. Multivariate logistic regression analysis showed that menarche age younger than 14 years (OR 0.470 [0.259, 0.852], P = 0.013), baseline AMH level higher than 0.5 ng/mL (OR 9.590 [3.366, 27.320], P < 0.001), pathological stage Ⅰ(OR 0.315 [0.124, 0.798], P = 0.015) and GnRHa application (OR 0.090 [0.045, 0.183], P < 0.001) were independent factors conducive to protection of ovarian reserve, as well as to recovery of ovarian reserve.
CONCLUSIONS


Age, menarche age, baseline AMH level, and GnRHa application are the most important influencing factors for ovarian reserve in premenopausal women with breast cancer.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02518191, registered on Aug 5, 2015.",2022,"The AMH level of the chemotherapy alone group decreased gradually within one year, while the AMH level of the GnRHa group was significantly higher as early as 6 months after chemotherapy and recovered to close to the baseline level 12 months after chemotherapy (F = 34.991, P < 0.001).","['Three hundred thirty premenopausal women aged 25-49 years with operable stage I to III breast cancer', 'premenopausal women with breast cancer', 'premenopausal female breast cancer patients in two parallel groups']","['chemotherapy with or without gonadotropin-releasing hormone analogs (GnRHa', 'ng/mL (OR']","['baseline AMH level', 'body mass index (BMI), reproductive history, baseline follicle stimulating hormone (FSH) level, pathological stage and GnRHa application', 'pathological stage', 'recovery of ovarian reserve', 'premature ovarian insufficiency (POI', 'GnRHa application', 'AMH level']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0206076', 'cui_str': 'History, Reproductive'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}]",330.0,0.448209,"The AMH level of the chemotherapy alone group decreased gradually within one year, while the AMH level of the GnRHa group was significantly higher as early as 6 months after chemotherapy and recovered to close to the baseline level 12 months after chemotherapy (F = 34.991, P < 0.001).","[{'ForeName': 'Xiangyun', 'Initials': 'X', 'LastName': 'Zong', 'Affiliation': ""Department of Breast Surgery, Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital, 600 Yishan Road, Shanghai, 200233, China. Electronic address: tigerzong@msn.com.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital), 1 Banshan Road, Hangzhou, 310022, China.'}, {'ForeName': 'Wenhu', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital), 1 Banshan Road, Hangzhou, 310022, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Zong', 'Affiliation': 'Department of Pharmacy, University of Michigan, United States.'}, {'ForeName': 'Hongjian', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital), 1 Banshan Road, Hangzhou, 310022, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Breast Surgery, Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital, 600 Yishan Road, Shanghai, 200233, China.""}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2022.05.009']
1534,35691568,Comparison of 25 mg and 10 mg of Empagliflozin in Heart Failure with Reduced Ejection Fraction.,This randomized controlled study aimed to compare the effects of different doses of empagliflozin on the prognosis of patients with heart failure with reduced ejection fraction (HFrEF). The results suggested that 25 mg empagliflozin could further reduce the incidence of the composite of heart failure hospitalization and cardiovascular death in HFrEF patients compared to 10 mg.,2022,The results suggested that 25 mg empagliflozin could further reduce the incidence of the composite of heart failure hospitalization and cardiovascular death in HFrEF patients compared to 10 mg.,['patients with heart failure with reduced ejection fraction (HFrEF'],"['Empagliflozin', 'empagliflozin']","['Heart Failure with Reduced Ejection Fraction', 'incidence of the composite of heart failure hospitalization and cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.079455,The results suggested that 25 mg empagliflozin could further reduce the incidence of the composite of heart failure hospitalization and cardiovascular death in HFrEF patients compared to 10 mg.,"[{'ForeName': 'Zhengyang', 'Initials': 'Z', 'LastName': 'Hao', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.'}, {'ForeName': 'Yanzhou', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China. Electronic address: zhangyanzhou666@outlook.com.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2022.05.026']
1535,35691487,"A pragmatic randomized trial of home-based testing for COVID-19 in rural native American and Latino communities: Protocol for the ""Protecting our Communities"" study.","BACKGROUND


Home-based testing for COVID-19 has potential to reduce existing health care disparities among underserved populations in the United States. However, implementation of home-based tests in these communities may face significant barriers. This study evaluates the acceptability, feasibility, and success of home-based testing and the potential added benefit of active support from trusted community health workers for Native Americans and Hispanic/Latino adults living in rural Montana and Washington states.
METHODS/DESIGN


The academic-community research team designed the trial to be responsive to community needs for understanding barriers and supports to home-based COVID-19 testing. The ""Protecting Our Community"" study is a two-arm pragmatic randomized controlled trial in which a total of 400 participants are randomized to active or passive arms. Participants of both study arms receive a commercially available home collection COVID-19 test kit, which is completed by mailing a self-collected nasal swab to a central laboratory. The primary study outcome is return of the kit to the central lab within 14 days. The cultural, social, behavioral, and economic barriers to home-based COVID-19 testing are also assessed by qualitative research methods. A survey and semi-structured interviews are conducted after the trial to evaluate perceptions and experience of home-based testing.
DISCUSSION


Implementing home-based testing in underserved populations, including among Native American and Hispanic/Latino communities, may require additional support to be successful. The Protecting Our Community trial examines the effect of trusted community health workers on use of home-based testing, which may be adaptable for community-driven models of home-based testing in other underserved populations.",2022,"BACKGROUND


Home-based testing for COVID-19 has potential to reduce existing health care disparities among underserved populations in the United States.","['rural native American and Latino communities', '400 participants', 'Native Americans and Hispanic/Latino adults living in rural Montana and Washington states']","['commercially available home collection COVID-19 test kit, which is completed by mailing a self-collected nasal swab to a central laboratory', 'home-based testing for COVID-19']",['return of the kit to the central lab within 14\u202fdays'],"[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0026506', 'cui_str': 'Montana'}, {'cui': 'C0043038', 'cui_str': 'Washington'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",400.0,0.136442,"BACKGROUND


Home-based testing for COVID-19 has potential to reduce existing health care disparities among underserved populations in the United States.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Thompson', 'Affiliation': 'Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA; Department of Family Medicine, University of Washington, Box 354696, Seattle, WA 98195, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Global Health, University of Washington, Box 351620, Seattle, WA 98195, USA; Department of Medicine, University of Washington, Box 356420, Seattle, WA 98195, USA; Department of Epidemiology, University of Washington, Box 351619, Seattle, WA 98195, USA.'}, {'ForeName': 'Charlie E', 'Initials': 'CE', 'LastName': 'Gregor', 'Affiliation': 'Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Hassell', 'Affiliation': 'Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA.'}, {'ForeName': 'Linda K', 'Initials': 'LK', 'LastName': 'Ko', 'Affiliation': 'Department of Health Systems and Population Health, University of Washington, Box 351621, Seattle, WA 98195, USA; Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA; Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue N, PO Box 19024, Seattle, WA 98109, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Lyon', 'Affiliation': 'Department of Family Medicine, University of Washington, Box 354696, Seattle, WA 98195, USA.'}, {'ForeName': 'Selena', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Center for American Indian and Rural Health Equity (CAIRHE), Montana State University, PO Box 173485, Bozeman, MT 59715, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bishop', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue N, PO Box 19024, Seattle, WA 98109, USA.'}, {'ForeName': 'Virgil', 'Initials': 'V', 'LastName': 'Dupuis', 'Affiliation': 'Salish Kootenai College, 58138 US-93, Pablo, MT, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Garza', 'Affiliation': 'Sunnyside School District, 1110 S 6th St., Sunnyside, WA, USA.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Lambert', 'Affiliation': 'Department of Medicine, University of Washington, Box 356420, Seattle, WA 98195, USA; Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA; Providence Medical Research Center, Providence Health Care, 105 W 8th Ave, Suite 6050W, Spokane, WA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Rowe', 'Affiliation': 'Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Warne', 'Affiliation': 'Center for American Indian and Rural Health Equity (CAIRHE), Montana State University, PO Box 173485, Bozeman, MT 59715, USA.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Webber', 'Affiliation': 'Center for American Indian and Rural Health Equity (CAIRHE), Montana State University, PO Box 173485, Bozeman, MT 59715, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Westbroek', 'Affiliation': 'Salish Kootenai College, 58138 US-93, Pablo, MT, USA.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Adams', 'Affiliation': 'Center for American Indian and Rural Health Equity (CAIRHE), Montana State University, PO Box 173485, Bozeman, MT 59715, USA. Electronic address: alexandra.adams2@montana.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106820']
1536,35691486,Women's Health Initiative strong and healthy (WHISH): A pragmatic physical activity intervention trial for cardiovascular disease prevention.,"BACKGROUND


National guidelines promote physical activity to reduce cardiovascular disease (CVD); yet, no RCT has tested the effectiveness of physical activity as the sole intervention for primary CVD prevention in older adults. The Women's Health Initiative (WHI) Strong and Healthy (WHISH) trial, a pragmatic trial embedded in the WHI-Extension Study (ES), is testing whether increasing physical activity and decreasing sedentary behavior will reduce major CV events in older women.
METHODS


The randomized consent design was used to assign 49,331 women (aged 68-99 years in 2015) who had consented to ongoing WHI-ES follow-up and for whom CV outcomes were available through WHI-ES procedures (N = 18,985) and/or linkage to the Centers for Medicare and Medicaid Services (N = 30,346) to a physical activity (PA) intervention designed to promote national recommendations (N = 24,657) or ""usual activity"" comparison (N = 24,674). Women assigned to the intervention provided passive consent to receive the intervention and provide data. A multi-component PA intervention is delivered by seasonal (quarterly) newsletters with targeted inserts (lower, middle, higher) based on self-reported levels of physical functioning (PF) and physical activity; monthly motivational telephone messages; monthly emails; a website; and contact with staff, as requested. Major CV events, myocardial infarction (MI), stroke, or CVD death, collected annually through WHI-ES, comprise the primary outcome. Hip fracture and non-CVD death are primary safety outcomes. Intention-to-treat analyses in all randomized participants will include 8 years of follow-up.
CONCLUSION


Determining whether increased physical activity and decreased sedentary behavior reduce major CV events in older women is of major public health significance.
CLINICALTRIALS REGISTRATION


ClinicalTrials.govidentifier:NCT02425345.",2022,"Major CV events, myocardial infarction (MI), stroke, or CVD death, collected annually through WHI-ES, comprise the primary outcome.","[""Women's Health Initiative strong and healthy (WHISH"", ""Women's Health Initiative (WHI"", '49,331 women (aged 68-99\u202fyears in 2015) who had consented to ongoing WHI-ES follow-up and for whom CV outcomes were available through WHI-ES procedures (N\u202f=\u202f18,985) and/or linkage to the Centers for Medicare and Medicaid Services', 'older adults', 'older women']","['physical activity (PA) intervention designed to promote national recommendations (N\u202f=\u202f24,657) or ""usual activity"" comparison']","['Major CV events, myocardial infarction (MI), stroke, or CVD death, collected annually through WHI-ES', 'Hip fracture and non-CVD death']","[{'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0041718', 'cui_str': 'Centers for Medicare and Medicaid Services'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]",49331.0,0.085177,"Major CV events, myocardial infarction (MI), stroke, or CVD death, collected annually through WHI-ES, comprise the primary outcome.","[{'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Department of Medicine, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, California, USA; Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California, USA. Electronic address: stefanick@stanford.edu.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kooperberg', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.'}, {'ForeName': 'Andrea Z', 'Initials': 'AZ', 'LastName': 'LaCroix', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA; Herbert Wertheim School of Public Health and Longevity Science, University of California San Diego, La Jolla, California, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106815']
1537,35691448,Definitive Local Consolidative Therapy for Oligometastatic Solid Tumors: Results from the Lead-In Phase of the Randomized Basket Trial EXTEND.,"PURPOSE


The benefit of local consolidative therapy (LCT) for oligometastasis across histologies remains uncertain. EXTernal beam radiation to Eliminate Nominal metastatic Disease (EXTEND; NCTXXXX) is a randomized phase II basket trial evaluating the effectiveness of LCT for oligometastatic solid tumors. We report here the prospective results of the single arm ""lead-in"" phase intended to identify histologies most likely to accrue to histology-specific endpoints in the randomized phase.
METHODS AND MATERIALS


Eligible histologies included colorectal, sarcoma, lung, head and neck, ovarian, renal, melanoma, pancreatic, prostate, cervix/uterine, breast, and hepatobiliary. Patients received LCT to all sites of active metastatic disease and primary/regional disease (as applicable) plus standard-of-care systemic therapy or observation. The primary endpoint in EXTEND was progression-free survival (PFS), and the primary endpoint of the lead-phase was histology-specific accrual feasibility. Adverse events were graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
RESULTS


From August 2018 through January 2019, 50 patients were enrolled and 49 received definitive LCT. Prostate, breast, and kidney were the highest enrolling histologies and identified for independent accrual in the randomization phase. Most patients (73%) had 1 or 2 metastases, most often in lung or bone (79%), and received ablative radiation (62%). Median follow-up for censored patients was 38 months (range 16-42 months). Median PFS was 13 months (95% CI 9-24), 3-year overall survival rate was 73% (95% CI 57%-83%), and local control rate was 98% (93 of 95 tumors). Two patients (4%) had CTCAE grade 3 toxicity related to LCT; no patient had grade 4 or 5 toxicity.
CONCLUSIONS


The prospective lead-in phase of the EXTEND basket trial demonstrated feasible accrual, encouraging PFS, and low severe-toxicity rates at mature follow-up. The randomized phase is ongoing with histology-based baskets that will provide histology-specific evidence for LCT in oligometastatic disease.",2022,"Median PFS was 13 months (95% CI 9-24), 3-year overall survival rate was 73% (95% CI 57%-83%), and local control rate was 98% (93 of 95 tumors).","['Eligible histologies included colorectal, sarcoma, lung, head and neck, ovarian, renal, melanoma, pancreatic, prostate, cervix/uterine, breast, and hepatobiliary', 'From August 2018 through January 2019, 50 patients were enrolled and 49 received', 'Oligometastatic Solid Tumors']","['Definitive Local Consolidative Therapy', 'LCT', 'ablative radiation', 'local consolidative therapy (LCT', 'definitive LCT']","['Median PFS', 'severe-toxicity rates', 'progression-free survival (PFS), and the primary endpoint of the lead-phase was histology-specific accrual feasibility', 'Adverse events', 'local control rate', '3-year overall survival rate', 'CTCAE grade 3 toxicity']","[{'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",50.0,0.139795,"Median PFS was 13 months (95% CI 9-24), 3-year overall survival rate was 73% (95% CI 57%-83%), and local control rate was 98% (93 of 95 tumors).","[{'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Sherry', 'Affiliation': 'Departments of Radiation Oncology, Division of Radiation Oncology.'}, {'ForeName': 'Tharakeswara K', 'Initials': 'TK', 'LastName': 'Bathala', 'Affiliation': 'Departments of Abdominal Imaging.'}, {'ForeName': 'Suyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Departments of Biostatistics.'}, {'ForeName': 'Bryan M', 'Initials': 'BM', 'LastName': 'Fellman', 'Affiliation': 'Departments of Biostatistics.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Chun', 'Affiliation': 'Departments of Radiation Oncology, Division of Radiation Oncology.'}, {'ForeName': 'Nikesh', 'Initials': 'N', 'LastName': 'Jasani', 'Affiliation': 'Departments of General Oncology.'}, {'ForeName': 'B Ashleigh', 'Initials': 'BA', 'LastName': 'Guadagnolo', 'Affiliation': 'Departments of Radiation Oncology, Division of Radiation Oncology.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Jhingran', 'Affiliation': 'Departments of Radiation Oncology, Division of Radiation Oncology.'}, {'ForeName': 'Jay P', 'Initials': 'JP', 'LastName': 'Reddy', 'Affiliation': 'Departments of Radiation Oncology, Division of Radiation Oncology.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'Amishi Y', 'Initials': 'AY', 'LastName': 'Shah', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'Kelsey W', 'Initials': 'KW', 'LastName': 'Kaiser', 'Affiliation': 'Departments of Radiation Oncology, Division of Radiation Oncology.'}, {'ForeName': 'Amol J', 'Initials': 'AJ', 'LastName': 'Ghia', 'Affiliation': 'Departments of Radiation Oncology, Division of Radiation Oncology.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Gomez', 'Affiliation': 'Departments of Radiation Oncology, Division of Radiation Oncology; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Departments of Radiation Oncology, Division of Radiation Oncology; Departments of Investigational Cancer Therapeutics; Departments of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: ctang1@mdanderson.org.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2022.05.023']
1538,35691371,Design and rationale of the Mobile health intervention for rural atrial fibrillation.,"BACKGROUND


Atrial fibrillation (AF) is a highly morbid condition which requires long-term adherence to oral anticoagulation and may be associated with adverse quality of life and health care utilization. We developed a relational agent - an interactive smartphone-based intervention accessible regardless of digital or health literacy - to assist individuals residing in rural, Western Pennsylvania, with AF with chronic disease self-management.
METHODS


The ""Mobile health intervention for rural atrial fibrillation"" is a single center, parallel-arm randomized clinical trial for adults with AF funded by the National Institute of Health's National Heart, Lung, and Blood Institute to enroll 264 participants. All participants receive a smartphone with data plan: The intervention is a 4-month relational agent coupled with the AliveCor Kardia for heart rate and rhythm monitoring provided by smartphone, and the control a pre-installed, smartphone-based application for health-related information (WebMD). The study uses remote recruitment and engagement to enroll individuals who would otherwise be unlikely to participate in clinical research due to rurality. The primary outcome of the trial is adherence to oral anticoagulation, determined by proportion of days covered, as measured at 12 months. The secondary outcomes are quality of life, both AF-specific and general, and health care utilization. The study entails a baseline visit, a 4-month intervention phase, and 8- and 12-month follow-up visits.
CONCLUSIONS


This mobile health trial tests the effectiveness of a smartphone-based relational agent to improve clinical and patient-reported outcomes in rural-dwelling individuals.",2022,"We developed a relational agent - an interactive smartphone-based intervention accessible regardless of digital or health literacy - to assist individuals residing in rural, Western Pennsylvania, with AF with chronic disease self-management.
","['rural-dwelling individuals', 'rural atrial fibrillation', ""adults with AF funded by the National Institute of Health's National Heart, Lung, and Blood Institute to enroll 264 participants""]","['relational agent - an interactive smartphone-based intervention accessible regardless of digital or health literacy - to assist individuals residing in rural, Western Pennsylvania, with AF with chronic disease self-management', 'Mobile health intervention', 'smartphone-based relational agent', 'relational agent coupled with the AliveCor Kardia for heart rate and rhythm monitoring provided by smartphone, and the control a pre-installed, smartphone-based application for health-related information (WebMD']","['quality of life, both AF-specific and general, and health care utilization', 'adherence to oral anticoagulation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1955970', 'cui_str': 'National Heart, Lung, and Blood Institute'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",,0.146523,"We developed a relational agent - an interactive smartphone-based intervention accessible regardless of digital or health literacy - to assist individuals residing in rural, Western Pennsylvania, with AF with chronic disease self-management.
","[{'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Magnani', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA; Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA. Electronic address: magnanij@pitt.edu.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ferry', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Swabe', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA.'}, {'ForeName': 'Xirun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA.'}, {'ForeName': 'Everlyne', 'Initials': 'E', 'LastName': 'Kimani', 'Affiliation': 'Human-Computer Interaction Institute, Northeastern University, Boston, MA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Department of General Internal Medicine, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Stefán', 'Initials': 'S', 'LastName': 'Ólafsson', 'Affiliation': 'Human-Computer Interaction Institute, Northeastern University, Boston, MA; Department of Computer Science, Reykjavik University, Iceland.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Bickmore', 'Affiliation': 'Human-Computer Interaction Institute, Northeastern University, Boston, MA.'}, {'ForeName': 'Samar R El', 'Initials': 'SRE', 'LastName': 'Khoudary', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA.'}]",American heart journal,['10.1016/j.ahj.2022.05.023']
1539,35691867,Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation.,"INTRODUCTION AND OBJECTIVES


The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system.
METHODS


Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days.
RESULTS


We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001).
CONCLUSIONS


Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.",2022,The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept.,"['consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers', 'A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III', 'mitral valve regurgitation', '68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5']",['PASCAL transcatheter edge-to-edge repair'],"['technical success and degree of residual MR at discharge', 'Technical success', 'MR etiology', 'MR', 'MAE rate', 'mortality rate', 'rate of major adverse events (MAE', 'functional status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439473', 'cui_str': 'Pa'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C3844009', 'cui_str': '4.5'}]","[{'cui': 'C0439473', 'cui_str': 'Pa'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",68.0,0.063668,The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept.,"[{'ForeName': 'Chi-Hion Pedro', 'Initials': 'CP', 'LastName': 'Li', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, IIB Sant Pau, Barcelona, Spain; Facultat de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain. Electronic address: CH.PedroLi@gmail.com.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Estévez-Loureiro', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Freixa', 'Affiliation': 'Servicio de Cardiología, Hospital Clínic de Barcelona, Institut Clínic Cardiovascular, Barcelona, Spain.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Teles', 'Affiliation': 'Serviço de Cardiologia, Hospital de Santa Cruz, Lisboa, Portugal.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Molina-Ramos', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain; Servicio de Cardiología, Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pan', 'Affiliation': 'Servicio de Cardiología, Hospital Reina Sofía, Universidad de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Nombela-Franco', 'Affiliation': 'Instituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Melica', 'Affiliation': 'Serviço de Cardiologia, Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Ignacio J', 'Initials': 'IJ', 'LastName': 'Amat-Santos', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain; Servicio de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz-González', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain; Servicio de Cardiología, Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Asmarats', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, IIB Sant Pau, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Alarcón', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sanchis', 'Affiliation': 'Servicio de Cardiología, Hospital Clínic de Barcelona, Institut Clínic Cardiovascular, Barcelona, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Fernández-Peregrina', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, IIB Sant Pau, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Baz', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Millán', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, IIB Sant Pau, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Menduiña', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, IIB Sant Pau, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain.'}, {'ForeName': 'Dabit', 'Initials': 'D', 'LastName': 'Arzamendi', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, IIB Sant Pau, Barcelona, Spain; Facultat de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2022.05.003']
1540,35691865,A classroom-based pilot of a self-compassion intervention to increase wellbeing in early adolescents.,"A Classroom-Based Pilot of a Self-Compassion Intervention to Increase Wellbeing in Early adolescents Abstract Objective:  Our first aim was to examine the effect of a 4-week self-compassion-based intervention on emotional well-being in a school classroom of early adolescents. The second aim was to evaluate feasibility and acceptability of the program within a classroom setting.  Design:  This study was a pre-post pilot design utilizing paired sample  t -tests to examine within-person changes in the outcome measures prior to, and following, the intervention. Bivariate correlations were also used to assess covariation between the pre-to-post change scores in self-compassion and the pre-to-post change scores in the outcome measures.
SETTING


The intervention was conducted during a wellbeing class at a culturally diverse secondary school.
PARTICIPANTS


The sample comprised 18 students aged 12- to 14-years old ( M age  = 12.44,  SD  = 0.61).  Intervention:  A brief self-compassion-based program, Be Kind to Yourself, Inspire Others, was developed specifically for early adolescents and delivered across four 70- minute lessons.
MAIN OUTCOME MEASURES


The outcome measures were self-compassion, resilience, perceived stress, social and general anxiety, and peer and school connectedness.
RESULTS


Findings revealed significant increases in self-compassion, resilience, and peer connectedness, and significant decreases in social and general anxiety at posttest, with small to medium effect sizes (Hedges'  g =  0.30-0.67). No significant differences were found for perceived stress and school connectedness. Pre-to-post changes in self-compassion covaried with pre-to-post changes in resilience and peer connectedness. Feasibility and acceptability were high. Findings suggest that a brief, classroom-based self-compassion intervention may be feasible and effective in improving indicators of emotional well-being among early adolescents.",2022,No significant differences were found for perceived stress and school connectedness.,"['early adolescents', 'The sample comprised 18 students aged 12- to 14-years old ( M age \xa0=\xa012.44,\xa0 SD \xa0=\xa00.61', 'school classroom of early adolescents']","['Self-Compassion Intervention', '4-week self-compassion-based intervention', 'self-compassion intervention', 'classroom-based self-compassion intervention']","['feasibility and acceptability', 'social and general anxiety', 'Feasibility and acceptability', 'perceived stress and school connectedness', 'self-compassion, resilience, and peer connectedness', 'self-compassion, resilience, perceived stress, social and general anxiety, and peer and school connectedness']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]",18.0,0.0233681,No significant differences were found for perceived stress and school connectedness.,"[{'ForeName': 'Veya', 'Initials': 'V', 'LastName': 'Seekis', 'Affiliation': 'School of Applied Psychology, Griffith University, Parklands Drive, Gold Coast 4222, Queensland, Australia. Electronic address: v.seekis@griffith.edu.au.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Farrell', 'Affiliation': 'School of Applied Psychology, Griffith University, Parklands Drive, Gold Coast 4222, Queensland, Australia. Electronic address: l.farrell@griffith.edu.au.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Zimmer-Gembeck', 'Affiliation': 'School of Applied Psychology, Griffith University, Parklands Drive, Gold Coast 4222, Queensland, Australia. Electronic address: m.zimmer-gembeck@griffith.edu.au.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2022.06.003']
1541,35692047,Improvement of functional outcome for patients with newly diagnosed grade 2 or 3 gliomas with co-deletion of 1p/19q - IMPROVE CODEL: the NOA-18 trial.,"BACKGROUND


Given the young age of patients with CNS WHO grade 2 and 3 oligodendrogliomas and the relevant risk of neurocognitive, functional, and quality-of-life impairment with the current aggressive standard of care treatment, chemoradiation with PCV, of the tumour located in the brain optimizing care is the major challenge.
METHODS


NOA-18 aims at improving qualified overall survival (qOS) for adult patients with CNS WHO grade 2 and 3 oligodendrogliomas by randomizing between standard chemoradiation with up to six six-weekly cycles with PCV and six six-weekly cycles with lomustine and temozolomide (CETEG) (n = 182 patients per group accrued over 4 years) thereby delaying radiotherapy and adding the chemoradiotherapy concept at progression after initial radiation-free chemotherapy, allowing for effective salvage treatment and delaying potentially deleterious side effects. QOS represents a new concept and is defined as OS without functional and/or cognitive and/or quality of life deterioration regardless of whether tumour progression or toxicity is the main cause. The primary objective is to show superiority of an initial CETEG treatment followed by partial brain radiotherapy (RT) plus PCV (RT-PCV) at progression over partial brain radiotherapy (RT) followed by procarbazine, lomustine, and vincristine (PCV) chemotherapy (RT-PCV) and best investigators choice (BIC) at progression for sustained qOS. An event concerning a sustained qOS is then defined as a functional and/or cognitive and/or quality of life deterioration after completion of primary therapy on two consecutive study visits with an interval of 3 months, tolerating a deviation of at most 1 month. Assessments are done with a 3-monthly MRI, assessment of the NANO scale, HRQoL, and KPS, and annual cognitive testing. Secondary objectives are evaluation and comparison of the two groups regarding secondary endpoints (short-term qOS, PFS, OS, complete and partial response rate). The trial is planned to be conducted at a minimum of 18 NOA study sites in Germany.
DISCUSSION


qOS represents a new concept. The present NOA trial aims at showing the superiority of CETEG plus RT-PCV over RT-PCV plus BIC as determined at the level of OS without sustained functional deterioration for all patients with oligodendroglioma diagnosed according to the most recent WHO classification.
TRIAL REGISTRATION


Clinicaltrials.gov NCT05331521 . EudraCT 2018-005027-16.",2022,NOA-18 aims at improving qualified overall survival (qOS) for adult patients with CNS WHO grade 2 and 3 oligodendrogliomas by randomizing between standard chemoradiation with up to six six-weekly cycles with PCV and six six-weekly cycles with lomustine and temozolomide (CETEG) (,"['18 NOA study sites in Germany', 'adult patients with CNS WHO grade 2 and 3 oligodendrogliomas by randomizing between standard chemoradiation with up to six six-weekly cycles with', 'patients with newly diagnosed grade 2 or 3 gliomas with co-deletion of 1p/19q - IMPROVE CODEL']","['QOS', 'partial brain radiotherapy (RT) plus PCV (RT-PCV) at progression over partial brain radiotherapy (RT) followed by procarbazine, lomustine, and vincristine (PCV) chemotherapy (RT-PCV', 'PCV and six six-weekly cycles with lomustine and temozolomide (CETEG) ']","['NANO scale, HRQoL, and KPS, and annual cognitive testing', 'qualified overall survival (qOS', 'secondary endpoints (short-term qOS, PFS, OS, complete and partial response rate']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0028945', 'cui_str': 'Oligodendroglioma, no ICD-O subtype'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0852224', 'cui_str': 'Brain radiotherapies'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",,0.148206,NOA-18 aims at improving qualified overall survival (qOS) for adult patients with CNS WHO grade 2 and 3 oligodendrogliomas by randomizing between standard chemoradiation with up to six six-weekly cycles with PCV and six six-weekly cycles with lomustine and temozolomide (CETEG) (,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic and National Centre for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sander', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Neurology Clinic and National Centre for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Combs', 'Affiliation': 'Department of Radiation Oncology at the Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Haut', 'Affiliation': 'Neurology Clinic and National Centre for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dormann', 'Affiliation': 'Neurology Clinic and National Centre for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Walter', 'Affiliation': 'Neurology Clinic and National Centre for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pertz', 'Affiliation': 'Department of Neurology, University Hospital Knappschaftskrankenhaus Bochum, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Merkle-Lock', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Medical Faculty & University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Selkrig', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Medical Faculty & University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Limprecht', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Baumann', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kieser', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sahm', 'Affiliation': 'Department of Neuropathology, University Hospital Heidelberg, DKTK and CCU Neuropathology, DKFZ, Heidelberg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Schlegel', 'Affiliation': 'Department of Neurology, University Hospital Knappschaftskrankenhaus Bochum, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Winkler', 'Affiliation': 'Neurology Clinic and National Centre for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Platten', 'Affiliation': 'DKTK, Clinical Cooperation Unit Neuroimmunology and Brain Tumor Immunology, DKFZ, Heidelberg, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic and National Centre for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Germany. wolfgang.wick@med.uni-heidelberg.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'Neurology Clinic and National Centre for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}]",BMC cancer,['10.1186/s12885-022-09720-z']
1542,35692038,A randomized clinical trial to assess the effect of zinc and vitamin D supplementation in addition to hypertonic saline on treatment of acute bronchiolitis.,"BACKGROUND


Bronchiolitis, the most common cause of hospitalization in infancy has not yet a definitive treatment. This study was conducted to assess the effect of Zinc and vitamin D on treatment of infants with bronchiolitis.
METHODS


In this double blind, randomized clinical trial, 94 infants aged 2 to 23 months, admitted in Mousavi Hospital in Zanjan, Iran, with the diagnosis of acute bronchiolitis were randomly assigned into 3 groups. The control group was only treated with hypertonic saline. The two case groups received either 100 unit/kg/day of Vitamin D or 20 mg/day of zinc in addition to hypertonic saline. Wheezing, duration of hospital stay, cough, cyanosis, respiratory distress and the respiratory rate in the first, third and seventh day of hospitalization were evaluated.
RESULTS


There was no significant difference between groups in terms of age, sex, weight, passive smoking, wheezing, oxygen saturation, cyanosis and type of delivery. On the third day of hospitalization, the respiratory rate/min in the control group, the groups receiving vitamin D and zinc were 45.2 ± 10.7, 37.8 ± 3.9 and 41.1 ± 9.1 respectively and the result of repeated measure analysis didn't show any significant difference between the 3 groups (P = 0.562). Duration of hospitalization in the group receiving Vitamin D or zinc and in controls were 4.2 ± 2.6, 4.4 ± 2.2 and 5.1 ± 2.4 days respectively and this difference was not significant. Zinc receiving patients did not differ from the control group regarding to respiratory rate, cyanosis and wheezing.
CONCLUSION


Vitamin D or zinc administration was not effective in reducing respiratory rate in children with bronchiolitis. Trial registration This project was approved by the Institutional Ethics Committee (IR, ZUMS.REC.1396.50), and registered on IRCT (IRCT20131217015835N7).",2022,"There was no significant difference between groups in terms of age, sex, weight, passive smoking, wheezing, oxygen saturation, cyanosis and type of delivery.","['children with bronchiolitis', '94 infants aged 2 to 23\xa0months, admitted in Mousavi Hospital in Zanjan, Iran, with the diagnosis of acute bronchiolitis', 'infants with bronchiolitis']","['zinc and vitamin D supplementation', 'Vitamin D or 20\xa0mg/day of zinc in addition to hypertonic saline', 'Zinc and vitamin D', 'hypertonic saline', 'Vitamin D or zinc administration']","['age, sex, weight, passive smoking, wheezing, oxygen saturation, cyanosis and type of delivery', 'Duration of hospitalization', 'respiratory rate', 'respiratory rate, cyanosis and wheezing', 'Wheezing, duration of hospital stay, cough, cyanosis, respiratory distress and the respiratory rate in the first, third and seventh day of hospitalization', 'acute bronchiolitis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0010520', 'cui_str': 'Cyanosis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}]",94.0,0.42913,"There was no significant difference between groups in terms of age, sex, weight, passive smoking, wheezing, oxygen saturation, cyanosis and type of delivery.","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Khoshnevisasl', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Sadeghzadeh', 'Affiliation': 'Metabolic Disease Research Center, Zanjan University of Medical Sciences, Zanjan, Iran. sadeghzadeh@zums.ac.ir.'}, {'ForeName': 'Koorosh', 'Initials': 'K', 'LastName': 'Kamali', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Armita', 'Initials': 'A', 'LastName': 'Ardalani', 'Affiliation': 'Department of Pediatrics, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",BMC infectious diseases,['10.1186/s12879-022-07492-2']
1543,35691974,Alpha/Theta Ratio Neurofeedback Training for Attention Enhancement in Normal Developing Children: A Brief Report.,"Attention plays an important role in children's development and learning, and neurofeedback training (NFT) has been proposed as a promising method to improve attention, mainly in population with attention problems such as attention deficit hyperactivity disorder. However, whether this approach has a positive effect on attention in normal developing children has been rarely investigated. This pilot study conducted ten sessions of alpha/theta ratio (ATR) NFT on eight primary students in school environment, with two to three sessions per week. The results showed inter-individual difference in NFT learning efficacy that was assessed by the slope of ATR over training sessions. In addition, the attention performance was significantly improved after NFT. Importantly, the improvement of attention performance was positively correlated with the NFT learning efficacy. It thus highlighted the need for optimizing ATR NFT protocol for the benefits on attention at the individual level. Future work can employ a double-blind placebo-controlled design with larger sample size to validate the benefits of ATR NFT for attention in normal developing children.",2022,The results showed inter-individual difference in NFT learning efficacy that was assessed by the slope of ATR over training sessions.,"['eight primary students in school environment, with two to three sessions per week', 'Normal Developing Children']","['Alpha/Theta Ratio Neurofeedback Training', 'ATR NFT', 'neurofeedback training (NFT', 'alpha/theta ratio (ATR) NFT', 'placebo']","['attention performance', 'NFT learning efficacy']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",8.0,0.0815135,The results showed inter-individual difference in NFT learning efficacy that was assessed by the slope of ATR over training sessions.,"[{'ForeName': 'Wenya', 'Initials': 'W', 'LastName': 'Nan', 'Affiliation': 'Department of Psychology, Shanghai Normal University, Shanghai, China.'}, {'ForeName': 'Mengqi', 'Initials': 'M', 'LastName': 'Wan', 'Affiliation': 'Department of Psychology, Shanghai Normal University, Shanghai, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychology, Shanghai Normal University, Shanghai, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Psychology, Shanghai Normal University, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wan', 'Affiliation': 'Department of Electrical and Computer Engineering, Faculty of Science and Engineering, University of Macau, Macau, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Cai', 'Affiliation': 'Department of Psychology, Shanghai Normal University, Shanghai, China. caidan@shnu.edu.cn.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-022-09550-6']
1544,35691955,ASO Visual Abstract: Preservation of Axillary Lymph Nodes Compared with Complete Dissection in T1-2 Breast Cancer Patients Presenting 1-2 Metastatic Sentinel Lymph Nodes: The Multicenter Randomized Clinical Trial SINODAR-ONE.,,2022,,"['T1-2 Breast Cancer Patients', 'Presenting 1-2 Metastatic Sentinel Lymph Nodes']",['Complete Dissection'],[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]",[],,0.206965,,"[{'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tinterri', 'Affiliation': 'Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Gentile', 'Affiliation': 'Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy. damiano.gentile@humanitas.it.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gatzemeier', 'Affiliation': 'Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sagona', 'Affiliation': 'Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Barbieri', 'Affiliation': 'Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Testori', 'Affiliation': 'Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Errico', 'Affiliation': 'Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bottini', 'Affiliation': 'Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Marrazzo', 'Affiliation': 'Breast Unit, Ospedale Maggiore di Lodi, Lodi, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Department of Epidemiology, Biostatistics and Clinical Trials, IRCCS S. Martino, IST, Genova, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Dozin', 'Affiliation': 'Department of Epidemiology, Biostatistics and Clinical Trials, IRCCS S. Martino, IST, Genova, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Department of Epidemiology, Biostatistics and Clinical Trials, IRCCS S. Martino, IST, Genova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': 'Department of Epidemiology, Biostatistics and Clinical Trials, IRCCS S. Martino, IST, Genova, Italy.'}, {'ForeName': 'Bethania', 'Initials': 'B', 'LastName': 'Fernandes', 'Affiliation': 'Department of Pathology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Franceschini', 'Affiliation': 'Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Ruggero', 'Initials': 'R', 'LastName': 'Spoto', 'Affiliation': 'Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Torrisi', 'Affiliation': 'Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Scorsetti', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Canavese', 'Affiliation': 'Breast Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgical oncology,['10.1245/s10434-022-11908-3']
1545,35691890,Efficacy of octreotide in bleeding recurrence from small bowel angioectasia: A comparative study.,"INTRODUCTION


Fifty percent of small bowel bleeding is caused by angioectasia and the rebleeding rate due to small bowel angioectasia (SBA) is 80%. Its endoscopic treatment is difficult. Beneficial effects of octreotide on gastrointestinal angioectasia have been described, but no studies have reported its efficacy in SBA.
AIM


Our aim was to investigate the effectiveness of octreotide in the prevention of rebleeding due to SBA.
MATERIAL AND METHODS


Sixteen patients with bleeding caused by SBA were assigned to treatment with octreotide 100 μg/24 h SC, for at least 6 months, and compared with a non-treatment group of 36 patients. The primary outcome was the rebleeding rate, and the secondary outcomes were the number of hospital readmissions, bleeding-related death, and adverse effects.
RESULTS


Octreotide was administered for 10.5 ± 8.4 months. Follow-up was 12.9 ± 17.3 months and 15.3 ± 17.7 months, in the treatment and non-treatment groups, respectively (p = 0.09). At the end of follow-up, 4 (25%) treatment group patients and 26 (72.2%) non-treatment group patients presented with rebleeding (p = 0.002). In the treatment group and non-treatment group, the cumulative probability of remaining rebleeding-free at one year was 79% vs 44.2%, and 79% vs 34.6% at 2 years, respectively (p = 0.05). Through the multiple logistic regression analysis, treatment was the protective variable. Six patients presented with adverse events. One of those patients (6.25%) had a major adverse event.
CONCLUSIONS


Our results suggest that treatment with octreotide could be efficacious in the prevention of rebleeding due to SBA.",2022,"In the treatment group and non-treatment group, the cumulative probability of remaining rebleeding-free at one year was 79% vs 44.2%, and 79% vs 34.6% at 2 years, respectively (p = 0.05).","['bleeding recurrence from small bowel angioectasia', 'Sixteen patients with bleeding caused by SBA']","['SBA', 'Octreotide', 'octreotide']","['adverse events', 'number of hospital readmissions, bleeding-related death, and adverse effects', 'cumulative probability of remaining rebleeding-free', 'rebleeding', 'rebleeding rate', 'major adverse event']","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",16.0,0.119181,"In the treatment group and non-treatment group, the cumulative probability of remaining rebleeding-free at one year was 79% vs 44.2%, and 79% vs 34.6% at 2 years, respectively (p = 0.05).","[{'ForeName': 'Á N', 'Initials': 'ÁN', 'LastName': 'Del Cueto-Aguilera', 'Affiliation': 'Servicio de Gastroenterología y Departamento de Medicina Interna, Facultad de Medicina, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'García-Compeán', 'Affiliation': 'Servicio de Gastroenterología y Departamento de Medicina Interna, Facultad de Medicina, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico. Electronic address: digarciacompean@prodigy.net.mx.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Jiménez-Rodríguez', 'Affiliation': 'Servicio de Gastroenterología y Departamento de Medicina Interna, Facultad de Medicina, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'O D', 'Initials': 'OD', 'LastName': 'Borjas-Almaguer', 'Affiliation': 'Servicio de Gastroenterología y Departamento de Medicina Interna, Facultad de Medicina, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Wah-Suárez', 'Affiliation': 'Servicio de Gastroenterología y Departamento de Medicina Interna, Facultad de Medicina, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'González-González', 'Affiliation': 'Servicio de Gastroenterología y Departamento de Medicina Interna, Facultad de Medicina, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Maldonado-Garza', 'Affiliation': 'Servicio de Gastroenterología y Departamento de Medicina Interna, Facultad de Medicina, Hospital Universitario «Dr. José E. González», Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}]",Revista de gastroenterologia de Mexico (English),['10.1016/j.rgmxen.2022.05.016']
1546,35692368,Virtual auscultation course via video chat in times of COVID-19 improves cardiac auscultation skills compared to literature self-study in third-year medical students: a prospective randomized controlled cross-over study.,"Background


Cardiac auscultation is a core clinical skill taught in medical school. Due to contact restrictions during the SARS-CoV-2 pandemic, interaction with patients was very limited. Therefore, a peer-to-peer virtual case-based auscultation course via video conference was established.
Methods


A randomized controlled cross-over study was conducted to evaluate whether participation in a virtual auscultation course could improve heart auscultation skills in 3 rd -year medical students. A total of sixty medical students were randomly assigned to either the experimental or control group after informed consent was obtained. Due to no-shows, 55 students participated. Depending on allocation, students attended three ninety-minute courses in intervals of one week in a different order: a virtual case-based auscultation course held via video chat, literature self-study, and an on-site course using a high-fidelity auscultation simulator (SAM II). The study's primary endpoint was the performance of the two groups at the simulator after participating in the virtual auscultation course or literature self-study. To evaluate their auscultation skills, students participated in five assessments using the same six pathologies: stenosis and regurgitation of the aortic and mitral valve, ventricular septal defect, and patent ductus arteriosus. Moreover, participants rated their satisfaction with each course and provided a self-assessment of competence.
Results


Compared to literature self-study, participation in the virtual auscultation course led to a significantly improved description of heart murmurs at the auscultation simulator with regard to the presence in systole and diastole, low- and high-pitched sounds, and volume dynamics. There was no significant difference between the groups in diagnostic accuracy and identification of the point of maximal intensity. After the virtual course, students showed higher satisfaction rates and a higher increase in self-assessed competence compared to participants who engaged in literature self-study.
Conclusions


For the first time, this study demonstrates that a case-based virtual auscultation course can improve aspects of cardiac auscultation skills on a simulator. This may facilitate the further acquisition of an essential clinical skill, even when contact restrictions will be lifted.",2022,"After the virtual course, students showed higher satisfaction rates and a higher increase in self-assessed competence compared to participants who engaged in literature self-study.
","['3 rd -year medical students', 'third-year medical students', 'students participated in five assessments using the same six pathologies: stenosis and regurgitation of the aortic and mitral valve, ventricular septal defect, and patent ductus arteriosus', '55 students participated', 'A total of sixty medical students']","['virtual case-based auscultation course held via video chat, literature self-study, and an on-site course using a high-fidelity auscultation simulator (SAM II']","['heart auscultation skills', 'diagnostic accuracy and identification of the point of maximal intensity', 'virtual auscultation course or literature self-study', 'cardiac auscultation skills', 'self-assessed competence', 'description of heart murmurs', 'satisfaction rates']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}]","[{'cui': 'C0018793', 'cui_str': 'Auscultation of heart'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0018808', 'cui_str': 'Heart murmur'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",60.0,0.0599293,"After the virtual course, students showed higher satisfaction rates and a higher increase in self-assessed competence compared to participants who engaged in literature self-study.
","[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Rüllmann', 'Affiliation': 'Heinrich-Heine-University Düsseldorf, Medical Faculty, Office of the dean of studies, Düsseldorf, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Hirtz', 'Affiliation': 'University of Duisburg-Essen, Department of Pediatrics II, Division of Pediatric Endocrinology and Diabetology, Essen, Germany.'}, {'ForeName': 'Unaa', 'Initials': 'U', 'LastName': 'Lee', 'Affiliation': ""University Children's Hospital Düsseldorf, Department of General Pediatrics, Neonatology and Pediatric Cardiology, Düsseldorf, Germany.""}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Klein', 'Affiliation': 'University Hospital Düsseldorf, Division of Cardiology, Pneumology and Angiology, Düsseldorf, Germany.'}, {'ForeName': 'Ertan', 'Initials': 'E', 'LastName': 'Mayatepek', 'Affiliation': ""University Children's Hospital Düsseldorf, Department of General Pediatrics, Neonatology and Pediatric Cardiology, Düsseldorf, Germany.""}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Malzkorn', 'Affiliation': 'Heinrich-Heine-University Düsseldorf, Medical Faculty, Office of the dean of studies, Düsseldorf, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Döing', 'Affiliation': 'Heinrich-Heine-University Düsseldorf, Medical Faculty, Office of the dean of studies, Düsseldorf, Germany.'}]",GMS journal for medical education,['10.3205/zma001542']
1547,35692277,"The Effects of Lidocaine, Fentanyl, and Remifentanil on Hemodynamics and Intraocular Eye Pressure After Tracheal Intubation: A Randomized Clinical Trial.","Objectives


An increased reflex in sympathetic and sympathoadrenal activity caused by tracheal intubation causes an increase in arterial blood pressure, and increased venous pressure causes an increase in intraocular pressure (IOP). The aim of the current study was to compare the effects of lidocaine, fentanyl, and remifentanil to determine which agent was most effective in the prevention of elevated IOP.
Methods


The patients were separated into 3 groups (lidocaine, fentanyl, and remifentanil). Heart rate and mean arterial pressure (MAP) were measured and recorded 2 min after the administration of the drugs and at 1, 5, and 10 min after intubation. IOP was measured and recorded in each eye separately by an ophthalmologist preoperatively, at 2 min after drug administration and at 1, 5, and 10 min after intubation.
Results


MAP was found to be high (122.750±17.068) in the lidocaine group at 1 min after intubation. In all 3 groups, the right and left eye IOP values were found to be higher at 1 min after intubation than at 2 min after drug administration. Only the difference in the lidocaine group was statistically significant (p=0.003). In all 3 groups, the right and left eye IOP values at 5 min after intubation were statistically significantly lower than the values at 1 min after intubation (Group 1: p=0.001, Group 2: p=0.000, and Group 3: p=0.000).
Conclusion


From the results of this study, it was concluded that remifentanil and fentanyl were more effective drugs than lidocaine in the prevention of increased IOP and hemodynamic response to intubation, and there was no significant difference between these two drugs.",2022,"In all 3 groups, the right and left eye IOP values were found to be higher at 1 min after intubation than at 2 min after drug administration.",[],"['remifentanil', 'Lidocaine, Fentanyl, and Remifentanil', 'lidocaine', 'lidocaine, fentanyl, and remifentanil']","['arterial blood pressure', 'Hemodynamics and Intraocular Eye Pressure', 'right and left eye IOP values', 'IOP and hemodynamic response', 'intraocular pressure (IOP', 'IOP', 'Heart rate and mean arterial pressure (MAP']",[],"[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.0410065,"In all 3 groups, the right and left eye IOP values were found to be higher at 1 min after intubation than at 2 min after drug administration.","[{'ForeName': 'Ali Caner', 'Initials': 'AC', 'LastName': 'Sayar', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences Turkey, Haydarpaşa Numune Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Deligoz', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences Turkey, Haydarpaşa Numune Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ferhunde Dilek', 'Initials': 'FD', 'LastName': 'Subasi', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences Turkey, Haydarpaşa Numune Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Imamoglu', 'Affiliation': 'Department of Ophthalmology, University of Health Sciences Turkey, Haydarpaşa Numune Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences Turkey, Haydarpaşa Numune Training and Research Hospital, Istanbul, Turkey.'}]",Beyoglu eye journal,['10.14744/bej.2022.79037']
1548,35692262,The Role of Chance in the Census Bureau Database Reconstruction Experiment.,"The Census Bureau plans a new approach to disclosure control for the 2020 census that will add noise to every statistic the agency produces for places below the state level. The Bureau argues the new approach is needed because the confidentiality of census responses is threatened by ""database reconstruction,"" a technique for inferring individual-level responses from tabular data. The Census Bureau constructed hypothetical individual-level census responses from public 2010 tabular data and matched them to internal census records and to outside sources. The Census Bureau did not compare these results to a null model to demonstrate that their success in matching would not be expected by chance. This is analogous to conducting a clinical trial without a control group. We implement a simple simulation to assess how many matches would be expected by chance. We demonstrate that most matches reported by the Census Bureau experiment would be expected randomly. To extend the metaphor of the clinical trial, the treatment and the placebo produced similar outcomes. The database reconstruction experiment therefore fails to demonstrate a credible threat to confidentiality.",2022,The Census Bureau did not compare these results to a null model to demonstrate that their success in matching would not be expected by chance.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0713897,The Census Bureau did not compare these results to a null model to demonstrate that their success in matching would not be expected by chance.,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ruggles', 'Affiliation': 'Institute for Social Research and Data Innovation, University of Minnesota, Minneapolis, Minnesota, USA, 55455.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Van Riper', 'Affiliation': 'Institute for Social Research and Data Innovation, University of Minnesota, Minneapolis, Minnesota, USA, 55455.'}]",Population research and policy review,['10.1007/s11113-021-09674-3']
1549,35692260,Neonatal azithromycin administration for prevention of infant mortality.,"Background


Biannual mass azithromycin administration reduces all-cause childhood mortality in some sub-Saharan African settings, with the largest effects in children aged 1-5 months. Azithromycin has not been distributed to children <1 month due to risk of infantile hypertrophic pyloric stenosis (IHPS).
Methods


This 1:1 placebo-controlled trial, randomized neonates aged 8-27 days to a single oral dose of azithromycin (20 mg/kg) or equivalent volume of placebo in 5 regions of Burkina Faso during 2019 and 2020. The primary outcome was all-cause mortality at 6 months of age. Infants were evaluated at 21 days after treatment and at 3 and 6 months of age for vital status; family and provider surveillance for IHPS continued throughout.
Results


Of 21,832 enrolled neonates, 10,898 were allocated to azithromycin and 10,934 to placebo. At 6 months of age, 92 infants had died, 42 (0.44%) in the azithromycin group and 50 (0.52%) in the placebo group (hazard ratio 0.85, 95% confidence interval 0.56 to 1.28,  P =0.46). A single IHPS case was detected, which was in the azithromycin arm. Serious adverse events, including death and hospitalization within 28 days of treatment, occurred in 0.27% of infants in the azithromycin group and 0.14% in the placebo group, for an absolute risk difference 0.14 percentage points, 95% confidence interval 0.01 to 0.26.
Conclusions


Overall mortality was lower than anticipated when the trial was designed, thus limiting its power. The available data do not support the routine use of azithromycin for prevention of mortality in neonates in sub-Saharan African settings similar to the one in which this trial was conducted.
Trial registration


ClinicalTrials.gov NCT03682653.",2022,"At 6 months of age, 92 infants had died, 42 (0.44%) in the azithromycin group and 50 (0.52%) in the placebo group (hazard ratio 0.85, 95% confidence interval 0.56 to 1.28,  P =0.46).","['21,832 enrolled neonates, 10,898 were allocated to', 'in 5 regions of Burkina Faso during 2019 and 2020']","['Neonatal azithromycin', 'azithromycin', 'Azithromycin', '\n\n\nBiannual mass azithromycin', 'placebo', 'azithromycin (20 mg/kg) or equivalent volume of placebo']","['Serious adverse events, including death and hospitalization', 'cause mortality', 'infant mortality', 'Overall mortality']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021278', 'cui_str': 'Mortality, Infant'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",21832.0,0.805185,"At 6 months of age, 92 infants had died, 42 (0.44%) in the azithromycin group and 50 (0.52%) in the placebo group (hazard ratio 0.85, 95% confidence interval 0.56 to 1.28,  P =0.46).","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Burkina Faso.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Bountogo', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Burkina Faso.'}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Zakane', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Burkina Faso.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Compaoré', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Burkina Faso.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Ouedraogo', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Burkina Faso.'}, {'ForeName': 'Fla', 'Initials': 'F', 'LastName': 'Koueta', 'Affiliation': 'Centre Hospitalier Universitaire Pédiatrique Charles-de-Gaulle, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brogdon', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, USA.'}, {'ForeName': 'Fanice', 'Initials': 'F', 'LastName': 'Nyatigo', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, USA.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",NEJM evidence,['10.1056/EVIDoa2100054']
1550,35692245,Comparative study of the effect of BlueM active oxygen gel and coe-pack dressing on postoperative surgical depigmentation healing.,"Introduction


Black colored gingiva is an esthetic concern, especially when accompanied by a high lip line or gummy smile.Surgical depigmentation with a scalpel is still considered the golden standard in gingival pigmentation management although it causes an area of open wound, which needs a special management with dressing.This study aimed to comparatively evaluate the effectiveness of reactive oxygen gel species (BlueM gel) and the traditional Coe-Pack dressing on gingival healing and pain after surgical depigmentation.
Materials and Methods


This split-mouth randomized clinical trial was conducted on 20 nonsmoking individuals aged 20-38 years with maxillary physiologic gingival pigmentation classes (III) and (IV) according to the Dummett-Gupta Oral Pigmentation Index (40 treated sites) who had requested an esthetic treatment for gingival hyperpigmentation of the maxillary gingiva.The maxilla was randomly divided into two symmetrical parts-from the right second premolar to the midline and from the midline to the left second premolar-to receive either BlueM gel or Coe-Pack as a dressing after surgical depigmentation with a scalpel. Various indices were assessed, such as pain and reepithelization index with toluidine blue, and the follow-up period was 1 month.
Results


A total of 20 patients were included in this study. There were statistically significant differences in the pain index after 1, 2, 3, 4, and 5 days. The BlueM gel group showed a higher significant difference after 1, 2, and 3 weeks in the reepithelization index.
Conclusion


Hence, BlueM gel can be considered as a good alternative for the Coe-Pack dressing after gingival depigmentation owing to its pain reduction properties, acceleration of wound healing, and postoperative reepithelization.",2022,"The BlueM gel group showed a higher significant difference after 1, 2, and 3 weeks in the reepithelization index.
","['A total of 20 patients were included in this study', '20 nonsmoking individuals aged 20-38\xa0years with maxillary physiologic gingival pigmentation classes (III) and (IV) according to the Dummett-Gupta Oral Pigmentation Index (40 treated sites) who had requested an esthetic treatment for gingival hyperpigmentation of the maxillary gingiva']","['reactive oxygen gel species (BlueM gel) and the traditional Coe-Pack dressing', 'BlueM gel or Coe-Pack as a dressing after surgical depigmentation with a scalpel', 'BlueM active oxygen gel and coe-pack dressing']","['postoperative surgical depigmentation healing', 'pain index', 'gingival healing and pain', 'pain and reepithelization index with toluidine blue']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1274808', 'cui_str': 'Gingival pigmentation'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0426517', 'cui_str': 'Pigmentation of oral mucosa'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877541', 'cui_str': 'Gingival hyperpigmentation'}, {'cui': 'C0227121', 'cui_str': 'Structure of gum of maxilla'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}]",20.0,0.0135177,"The BlueM gel group showed a higher significant difference after 1, 2, and 3 weeks in the reepithelization index.
","[{'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Juliana', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Damascus University, Mazzeh, Damascus, Syria.'}, {'ForeName': 'Shwaiki', 'Initials': 'S', 'LastName': 'Tarek', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Damascus University, Mazzeh, Damascus, Syria.'}]",The Saudi dental journal,['10.1016/j.sdentj.2022.04.005']
1551,35692243,"Comparative study of local anesthetic efficacy of 5% tramadol versus 2 %Lignocaine with 1:100,000 adrenaline for extraction of fully erupted maxillary 3rd molars using infiltration anesthesia.","Introduction


The majority of dental procedures need local anesthesia for pain control, and lidocaine/ lignocaine is the most commonly used anesthetic agent in dentistry. Although effective and safest, the anesthetic agent still has some complications. To overcome these many alternatives have been used. Tramadol has been shown to have some local anesthetic (LA) effects when used for infiltration anesthesia in dentistry.
Methods


In the present study, the local anesthetic efficacy of tramadol was compared with 2% lignocaine containing 1: 100,000 adrenaline for the extraction of maxillary fully erupted 3rd molar teeth. The parameters recorded included the onset of action, duration of action, intraoperative pain, post-operative analgesic effect, and incidence of an allergic reaction. A total of 200 patients were randomly divided into two groups. In group A -Each patient received 0.6 ml of 5% tramadol (Tramataj- 50 mg prepared by Taj pharma company) 0.4 ml buccally and 0.2 ml palatally for extraction of maxillary 3rd molar as local infiltration following strict aseptic precaution. In Group B- patients received 0.6 ml of 2% lignocaine containing 1: 100,000 adrenaline buccally and 0.2 ml palatally as infiltrations.
Results


It was found that 5% tramadol has a local anesthetic efficacy similar to 2% lignocaine with adrenaline but was found to be a comparatively weaker agent.
Conclusion


tramadol is a valid alternative for performing extractions in normal patients or patients allergic to lidocaine.",2022,"It was found that 5% tramadol has a local anesthetic efficacy similar to 2% lignocaine with adrenaline but was found to be a comparatively weaker agent.
","['normal patients or patients allergic to lidocaine', '200 patients', 'fully erupted maxillary 3rd molars using infiltration anesthesia']","['lidocaine/ lignocaine', 'lignocaine', 'tramadol (Tramataj- 50\xa0mg prepared by Taj pharma company', 'adrenaline buccally and 0.2\xa0ml palatally as infiltrations', 'adrenaline', 'Tramadol', 'Lignocaine with 1:100,000 adrenaline', 'tramadol']","['local anesthetic efficacy', 'onset of action, duration of action, intraoperative pain, post-operative analgesic effect, and incidence of an allergic reaction']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",200.0,0.0120169,"It was found that 5% tramadol has a local anesthetic efficacy similar to 2% lignocaine with adrenaline but was found to be a comparatively weaker agent.
","[{'ForeName': 'Ahtesham', 'Initials': 'A', 'LastName': 'Ahmad Qureshi', 'Affiliation': 'Department of Maxillofacial Surgery and Diagnostic Sciences, College of Dentistry Jazan University, Jazan Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Mousa Bakri', 'Affiliation': 'Department of Maxillofacial Surgery and Diagnostic Sciences, College of Dentistry Jazan University, Jazan Saudi Arabia.'}]",The Saudi dental journal,['10.1016/j.sdentj.2022.03.002']
1552,35692238,Clinical efficacy of hydroxyapatite toothpaste containing Polyol Germanium Complex (PGC) with threonine in the treatment of dentine hypersensitivity.,"Introduction


This study aims to evaluate the clinical efficacy of a hydroxyapatite toothpaste containing a Polyol Germanium Complex with threonine in treating dentine hypersensitivity. The study also seeks to monitor the quality of life of the treated dentine hypersensitivity sufferers.
Materials and methods


This study is a randomized clinical trial with a total of 120 patients with dentine hypersensitivity. All participants were divided into three groups: patients assigned to the GARDA SILK toothpaste; patients receiving the conventional fluoride toothpaste for comparison purposes, and patients asked to brush their teeth without toothpaste. The modified Quigley-Heine Plaque Index was assessed at the baseline and after treatment. Sensitivity was assessed at baseline, 3, 7 and 14 days using the air stimulus (Schiff Index). The impact of dentine hypersensitivity on the quality of life was assessed before and after the treatment with the Russian version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ).
Results


After 14 days of treatment, the mean Plaque Index scores in Groups 1 and 2 did not exceed 1 and averaged 0.72 ± 0.249 and 0.86 ± 0.213, respectively. In Group 3, the mean Plaque Index was significantly higher (1.04 ± 0.070, p < 0.05). The mean Schiff sensitivity scores in Group 1 decreased to 2.45 ± 0.42 at 3 days, 1.84 ± 0.26 at 7 days, and 1.02 ± 0.34 at 14 days. Group 2 exhibited smaller reductions in the Schiff index at all time points. In this group, Schiff scores dropped to 2.67 ± 0.28 after 3 days, 2.34 ± 0.44 after 7 days, and 1.93 ± 0.36 after 14 days.
Conclusion


The GARDA SILK hydroxyapatite toothpaste with a threonine-containing Polyol Germanium Complex (PGC) is effective in maintaining good oral hygiene, reducing dentine hypersensitivity, and improving the quality of life of dentine hypersensitivity sufferers.",2022,"The impact of dentine hypersensitivity on the quality of life was assessed before and after the treatment with the Russian version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ).
","['120 patients with dentine hypersensitivity', 'dentine hypersensitivity']","['hydroxyapatite toothpaste containing Polyol Germanium Complex (PGC) with threonine', 'hydroxyapatite toothpaste', 'threonine-containing Polyol Germanium Complex (PGC', 'conventional fluoride toothpaste', 'GARDA SILK toothpaste']","['Dentine Hypersensitivity Experience Questionnaire (DHEQ', 'Sensitivity', 'Schiff scores', 'quality of life', 'mean Plaque Index scores', 'Schiff index', 'mean Schiff sensitivity scores', 'modified Quigley-Heine Plaque Index', 'mean Plaque Index']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}]","[{'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0017479', 'cui_str': 'Germanium'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0040005', 'cui_str': 'Threonine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0074529', 'cui_str': 'Silk'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",120.0,0.0558518,"The impact of dentine hypersensitivity on the quality of life was assessed before and after the treatment with the Russian version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ).
","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Vlasova', 'Affiliation': 'Department of Therapeutic Dentistry, The State Education Institution of Higher Professional Training The First Sechenov Moscow State Medical University under Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Samusenkov', 'Affiliation': 'Department of Prosthetic Dentistry, The State Education Institution of Higher Professional Training The First Sechenov Moscow State Medical University under Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Novikova', 'Affiliation': 'Department of Therapeutic Dentistry, The State Education Institution of Higher Professional Training The First Sechenov Moscow State Medical University under Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nikolenko', 'Affiliation': 'Department of Prosthetic Dentistry, The State Education Institution of Higher Professional Training The First Sechenov Moscow State Medical University under Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Nikolashvili', 'Affiliation': 'Department of Prosthetic Dentistry, The State Education Institution of Higher Professional Training The First Sechenov Moscow State Medical University under Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Gor', 'Affiliation': 'Department of Surgical Dentistry, The State Education Institution of Higher Professional Training The First Sechenov Moscow State Medical University under Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Danilina', 'Affiliation': 'Department of Therapeutic Dentistry, The State Education Institution of Higher Professional Training The First Sechenov Moscow State Medical University under Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}]",The Saudi dental journal,['10.1016/j.sdentj.2022.03.001']
1553,35692220,"Favipiravir, camostat, and ciclesonide combination therapy in patients with moderate COVID-19 pneumonia with/without oxygen therapy: An open-label, single-center phase 3 randomized clinical trial.","Background


The effectiveness of combination therapy for COVID-19 pneumonia remains unclear. We evaluated favipiravir, camostat, and ciclesonide combination therapy in patients with moderate COVID-19 pneumonia.
Methods


In this open-label phase 3 study, hospitalized adults who were positive for SARS-CoV-2 and had COVID-19 pneumonia were enrolled prior to official vaccination drive in Japan. Participants were randomly assigned to favipiravir monotherapy or favipiravir + camostat + ciclesonide combination therapy. The primary outcome was the length of hospitalization due to COVID-19 infection after study treatment. The hospitalization period was calculated from the time of admission to the time of patient discharge using the clinical management guide of COVID-19 for front-line healthcare workers developed by the Japanese Ministry of Health, Labour, and Welfare (Version 3). Cases were registered between November 11, 2020, and May 31, 2021. Japan Registry of Clinical Trials registration: jRCTs031200196.
Findings


Of 121 enrolled patients, 56 received monotherapy and 61 received combination therapy. Baseline characteristics were balanced between the groups. The median time of hospitalization was 10 days for the combination and 11 days for the monotherapy group. The median time to discharge was statistically significantly lower in the combination therapy vs monotherapy group (HR, 1·67 (95% CI 1·03-2·7; P = 0·035). The hospital discharge rate was statistically significantly higher in the combination therapy vs monotherapy group in patients with less severe COVID-19 infections and those who were ≤60 years. There were no significant differences in clinical findings between the groups at 4, 8, 11, 15, and 29 days. Adverse events were comparable between the groups. There were two deaths, with one in each group.
Interpretation


Combination oral favipiravir, camostat and, ciclesonide therapy could decrease the length of hospitalization stays without safety concerns in patients with moderate COVID-19 pneumonia. However, lack of hard clinical primary outcome is one of the major limitations of the study.
Funding


This research was supported by Japan Agency for Medical Research and Development (AMED) under Grant Number 20fk0108261h0001.",2022,"There were no significant differences in clinical findings between the groups at 4, 8, 11, 15, and 29 days.","['hospitalized adults who were positive for SARS-CoV-2 and had COVID-19 pneumonia were enrolled prior to official vaccination drive in Japan', '121 enrolled patients, 56 received', 'patients with moderate COVID-19 pneumonia', 'patients with moderate COVID-19 pneumonia with/without oxygen therapy']","['Interpretation\n\n\nCombination oral favipiravir, camostat and, ciclesonide therapy', 'monotherapy', 'ciclesonide combination therapy', 'combination therapy', 'favipiravir monotherapy or favipiravir\xa0+\xa0camostat\xa0+\xa0ciclesonide combination therapy']","['length of hospitalization stays', 'length of hospitalization due to COVID-19 infection', 'median time of hospitalization', 'Adverse events', 'median time to discharge', 'hospital discharge rate']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0129975', 'cui_str': 'camostat'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",121.0,0.163998,"There were no significant differences in clinical findings between the groups at 4, 8, 11, 15, and 29 days.","[{'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Terada', 'Affiliation': 'Department of Pulmonary Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan.'}, {'ForeName': 'Retsu', 'Initials': 'R', 'LastName': 'Fujita', 'Affiliation': 'Innovation and Research Support Center, Graduate School of Medicine, International University of Health and Welfare, Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Clinical Research Promotion Center, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Hirasawa', 'Affiliation': 'Department of Pulmonary Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Pulmonary Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Takeshita', 'Affiliation': 'Department of Pulmonary Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Isaka', 'Affiliation': 'Department of Pulmonary Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kinouchi', 'Affiliation': 'Department of Pulmonary Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tajima', 'Affiliation': 'Department of Pulmonary Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Tada', 'Affiliation': 'Department of Pulmonary Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsushima', 'Affiliation': 'Department of Pulmonary Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan.'}]",EClinicalMedicine,['10.1016/j.eclinm.2022.101484']
1554,35692209,[Effect of neuromuscular electrical stimulation on muscle strength in patients with mechanical ventilation in intensive care unit: cumulative Meta-analysis and trial sequential analysis].,"OBJECTIVE


To evaluate the effect of neuromuscular electrical stimulation (NMES) on muscle strength and duration of mechanical ventilation through cumulative Meta-analysis and sequential trial analysis (TSA).
METHODS


Randomized controlled trial (RCT) of NMES intervention in intensive care unit (ICU) patients with mechanical ventilation were searched from PubMed database of US National Library of Medicine, EMbase database of Netherlands Medical Abstract, Web of Science, SinoMed database of China, CNKI, Wanfang data, VIP and other Chinese and English databases from database construction to July 15, 2021. The control group received ICU routine nursing or rehabilitation exercise; the experimental group received NMES (low frequency electric current through electrode stimulation to make muscle groups twitch or contract) based on routine care in ICU. Relevant data were screened, evaluated and extracted by two researchers independently. After extracting data, STATA 15.0 and TSA software were used to analyze the data and evaluate the research results.
RESULTS


A total of 9 studies were enrolled, including 619 subjects. Among the 9 articles included, 2 were grade A and 7 were grade B, indicating good overall quality. Cumulative Meta-analysis showed that compared with ICU routine care, NMES improved muscle strength of patients undergoing mechanical ventilation [standardized mean difference (SMD) = 0.64, 95% confidence interval (95%CI) was 0.07 to 1.21] and shortened the duration of mechanical ventilation (SMD = -1.84, 95%CI was -2.58 to -1.10). TSA analysis of the two outcomes showed that the sample size of muscle strength outcome index (n = 518) and mechanical ventilation outcome index (n = 419) did not meet the expected information (RIS; n values of 618 and 685); the cumulative Z-value line of the muscle strength outcome index crossed the traditional boundary line and TSA boundary line, indicating that more tests were not needed to verify this result. In the outcome index of mechanical ventilation duration, it was found that the cumulative Z-value line only crossed the traditional boundary line, but did not cross the TSA boundary line, indicating that further studies in this area should be carried out in the future to demonstrate this result.
CONCLUSION


NMES can improve ICU patients' muscle strength and reduce the duration of mechanical ventilation.",2022,"TSA analysis of the two outcomes showed that the sample size of muscle strength outcome index (n = 518) and mechanical ventilation outcome index (n = 419) did not meet the expected information (RIS; n values of 618 and 685); the cumulative Z-value line of the muscle strength outcome index crossed the traditional boundary line and TSA boundary line, indicating that more tests were not needed to verify this result.","['A total of 9 studies were enrolled, including 619 subjects', 'intensive care unit (ICU) patients with mechanical ventilation were searched from PubMed database of US National Library of Medicine, EMbase database of Netherlands Medical Abstract, Web of Science, SinoMed database of China, CNKI, Wanfang data, VIP and other Chinese and English databases from database construction to July 15, 2021', 'patients with mechanical ventilation in intensive care unit']","['NMES intervention', 'neuromuscular electrical stimulation', 'neuromuscular electrical stimulation (NMES', 'NMES (low frequency electric current through electrode stimulation to make muscle groups twitch or contract) based on routine care in ICU', 'NMES', 'ICU routine nursing or rehabilitation exercise']","['muscle strength', 'mechanical ventilation outcome index', ""ICU patients' muscle strength"", 'muscle strength and duration of mechanical ventilation', 'duration of mechanical ventilation', 'duration of mechanical ventilation ']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1138432', 'cui_str': 'PubMed'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0027470', 'cui_str': 'National Library of Medicine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042395', 'cui_str': 'vasoactive intestinal peptide'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0585865,"TSA analysis of the two outcomes showed that the sample size of muscle strength outcome index (n = 518) and mechanical ventilation outcome index (n = 419) did not meet the expected information (RIS; n values of 618 and 685); the cumulative Z-value line of the muscle strength outcome index crossed the traditional boundary line and TSA boundary line, indicating that more tests were not needed to verify this result.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Second Affiliated Hospital of Nanchang University, Nanchang 330000, Jiangxi, China.'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'School of Nursing, Nanchang University, Nanchang 330006, Jiangxi, China. Corresponding author: Li Dongying, Email: sunfang100@126.com.'}, {'ForeName': 'Jianting', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Critical Care Medicine, Second Affiliated Hospital of Nanchang University, Nanchang 330000, Jiangxi, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Second Affiliated Hospital of Nanchang University, Nanchang 330000, Jiangxi, China.'}, {'ForeName': 'Dongying', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Second Affiliated Hospital of Nanchang University, Nanchang 330000, Jiangxi, China.'}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20210915-01375']
1555,35692201,[Construction and verification of the risk prediction model for acute exacerbation within 6 months in patients with chronic obstructive pulmonary disease: a secondary analysis based on previous research data].,"OBJECTIVE


To construct the risk prediction model of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and verify its effectiveness based on deep learning and back propagation algorithm neural network (BP neural network).
METHODS


Based on the relevant data of 1 326 patients with chronic obstructive pulmonary disease (COPD) in the team's previous clinical study, the acute exacerbation, and its risk factors during the stable period and 6 months of follow-up were recorded and analyzed. Combined with previous clinical research data and expert questionnaire results, the independent risk factors of AECOPD after screening and optimization by multivariate Logistic regression including gender, body mass index (BMI) classification, number of acute exacerbation, duration of acute exacerbation and forced expiratory volume in one second (FEV1) were used to build the BP neural network by Python 3.6 programming language and Tensorflow 1.12 deep learning framework. The patients were randomly selected according to the ratio of 4:1 to generate the training group and the test group, of which, the training group had 1 061 sample data while the test group had 265 pieces of sample data. The training group was used to establish the prediction model of neural network, and the test group was used for back-substitution test. When using the training group data to construct the neural network model, the training group was randomly divided into training set and verification set according to the ratio of 4:1. There were 849 training samples in the training set and 212 verification samples in the verification set. The optimal model was screened by adjusting the parameters of the neural network and combining the area under the receiver operator characteristic curve (AUC), and the sample data of the test group was substituted into the model for verification.
RESULTS


The independent risk factors including gender, BMI classification, number of acute exacerbation, duration of acute exacerbation and FEV1 were collected from the team's previous clinical research, and the AECOPD risk prediction model was constructed based on deep learning and BP neural network. After 10 000 training sessions, the accuracy of the AECOPD risk prediction model in the validation set of the training group was 83.09%. When the number of training times reached 8 000, the accuracy basically tended to be stable and the prediction ability reached the upper limit. The AECOPD risk prediction model trained for 10 000 times was used to predict the risk of the validation set data, and the receiver operator characteristic curve (ROC curve) analysis showed that the AUC was 0.803. When using this model to predict the risk of the data of the test group, the accuracy rate was 81.69%.
CONCLUSION


The risk prediction model based on deep learning and BP neural network has a medium level of prediction efficiency for acute exacerbation within 6 months in COPD patients, which can evaluate the risk of AECOPD and assist the clinic in making accurate treatment decisions.",2022,"The risk prediction model based on deep learning and BP neural network has a medium level of prediction efficiency for acute exacerbation within 6 months in COPD patients, which can evaluate the risk of AECOPD and assist the clinic in making accurate treatment decisions.","['chronic obstructive pulmonary disease (AECOPD', '326 patients with chronic obstructive pulmonary disease (COPD', 'patients with chronic obstructive pulmonary disease']",[],"['accuracy rate', 'accuracy of the AECOPD risk prediction model', 'gender, BMI classification, number of acute exacerbation, duration of acute exacerbation and FEV1', 'body mass index (BMI) classification, number of acute exacerbation, duration of acute exacerbation and forced expiratory volume']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",1326.0,0.0447063,"The risk prediction model based on deep learning and BP neural network has a medium level of prediction efficiency for acute exacerbation within 6 months in COPD patients, which can evaluate the risk of AECOPD and assist the clinic in making accurate treatment decisions.","[{'ForeName': 'Minghang', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan, China.'}, {'ForeName': 'Kunkun', 'Initials': 'K', 'LastName': 'Cai', 'Affiliation': 'Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan, China.'}, {'ForeName': 'Dingli', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan, China.'}, {'ForeName': 'Lichan', 'Initials': 'L', 'LastName': 'Bi', 'Affiliation': 'Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan, China.'}, {'ForeName': 'Jiansheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Respiratory Disease Diagnosis and Treatment and New Drug Research and Development Provincial and Ministry Co-built Collaborative Innovation Center, Henan University of Traditional Chinese Medicine, Henan Key Laboratory of Chinese Medicine for Respiratory Diseases, Zhengzhou 450046, Henan, China. Corresponding author: Li Jiansheng, Email: li_js8@163.com.'}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20210929-01414']
1556,35692186,Effect Compartment Model for Evaluation of Tolerance to Psychological Highness following Marijuana Smoking.,"The purpose of this study is to evaluate the development of tolerance, using population modeling approach, in recreational Marijuana users after acute pulmonary administration of tetrahydrocannabinol, a primary ingredient in Marijuana. Total of 85 subjects in three separate studies smoked Marijuana cigarettes (dose = 13-49 mg) under controlled conditions. Each study was designed as a randomized, crossover, double-blind, and placebo-controlled study. Up to five tetrahydrocannabinol plasma samples and corresponding user-reported psychological highness were pooled for population modeling analyses. Age, sex, user status, and BMI were evaluated as covariates. Population PK parameters were estimated in the 2-compartment PK model. PK parameters were fixed in the effect compartment model to describe the tetrahydrocannabinol plasma concentration-psychological highness relationship. The distribution rate constant in the effect compartment was estimated to be 0.988 (0.964 - 1.01, 95% C.I.) h -1  . Population mean EC 50  was 23.8 (22.7 - 24.9, 95% C.I.) ng/mL. Covariate analysis revealed that user status was a significant covariate and chronic users appear to need higher plasma concentrations compared to occasional users, to achieve a similar degree of highness. The modeling results conclude that chronic users are exhibiting the development of tolerance to euphoria, a primary central nervous system effect after Marijuana smoking. This article is protected by copyright. All rights reserved.",2022,"Population mean EC 50  was 23.8 (22.7 - 24.9, 95% C.I.) ng","['recreational Marijuana users after acute pulmonary administration of tetrahydrocannabinol, a primary ingredient in Marijuana', 'Marijuana Smoking', 'Total of 85 subjects in three separate studies smoked Marijuana cigarettes (dose = 13-49 mg) under controlled conditions']",['placebo'],['distribution rate constant'],"[{'cui': 'C4518790', 'cui_str': 'Marijuana user'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",85.0,0.0449066,"Population mean EC 50  was 23.8 (22.7 - 24.9, 95% C.I.) ng","[{'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Singla', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Iowa, Iowa City, Iowa, 52246, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Block', 'Affiliation': 'Department of Anesthesia, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.2109']
1557,35692580,Effectiveness of Proanthocyanidin plus Trimetazidine in the Treatment of Non-Small-Cell Lung Cancer with Radiation Heart Injury.,"This study was intended to explore the effect of proanthocyanidin (PC) combined with trimetazidine in non-small-cell lung cancer (NSCLC) with radiation-induced heart damage (RIHD). It was a prospective randomized controlled study that 86 NSCLC patients with radiation treatment in Cangzhou People's Hospital from January 2019 and June 2021 were enrolled and randomized to either the control group or the study group via the random table method, 43 cases in each group. The control group received trimetazidine, and the study group additionally received PC. The incidence of RIHD-related clinical manifestation, RIHD-related ECG, and RIHD-related cardiac ultrasound change were all lower in the study group. After radiotherapy, the serum level of superoxide dismutase (SOD) was higher, and malondialdehyde (MDA) was lower in the study group when compared with the control group. After radiotherapy, the serum levels of brain natriuretic peptide (BNP), cardiac troponin (cTnT), creatine kinase (CK), and creatine kinase isoenzymes (CKMB) were all lower in the study group when compared with the control group. The efficacy of PC plus trimetazidine for NSCLC with RIHD is superior to trimetazidine alone, and it significantly mitigates radiation-induced inflammatory response and oxidative stress.",2022,"After radiotherapy, the serum level of superoxide dismutase (SOD) was higher, and malondialdehyde (MDA) was lower in the study group when compared with the control group.","[""86 NSCLC patients with radiation treatment in Cangzhou People's Hospital from January 2019 and June 2021"", 'non-small-cell lung cancer (NSCLC) with radiation-induced heart damage (RIHD', 'Non-Small-Cell Lung Cancer with Radiation Heart Injury']","['Proanthocyanidin plus Trimetazidine', 'PC', 'PC plus trimetazidine', 'proanthocyanidin (PC) combined with trimetazidine', 'trimetazidine']","['incidence of RIHD-related clinical manifestation, RIHD-related ECG, and RIHD-related cardiac ultrasound change', 'serum level of superoxide dismutase (SOD', 'serum levels of brain natriuretic peptide (BNP), cardiac troponin (cTnT), creatine kinase (CK), and creatine kinase isoenzymes (CKMB', 'malondialdehyde (MDA']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522449', 'cui_str': 'Radiation therapy procedure or service'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0018805', 'cui_str': 'Injury of heart'}]","[{'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0010288', 'cui_str': 'Creatine kinase isoenzyme'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}]",86.0,0.0611383,"After radiotherapy, the serum level of superoxide dismutase (SOD) was higher, and malondialdehyde (MDA) was lower in the study group when compared with the control group.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Ward I, Department of Cardiovascular Medicine, Cangzhou People's Hospital, Cangzhou, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department II of Radiotherapy, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Yucui', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Ward I, Department of Cardiovascular Medicine, Cangzhou People's Hospital, Cangzhou, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Ward I, Department of Cardiovascular Medicine, Cangzhou People's Hospital, Cangzhou, China.""}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Ward I, Department of Cardiovascular Medicine, Cangzhou People's Hospital, Cangzhou, China.""}, {'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': ""Ward I, Department of Cardiovascular Medicine, Cangzhou People's Hospital, Cangzhou, China.""}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/2338622']
1558,35692575,Exploration on the Improvement of Cognitive Function and Inflammatory Response in Perimenopausal Patients with Mild Cognitive Impairment by Self-Prepared Ningshen Prescription.,"Objective


To investigate the improvement of cognitive function and inflammatory response in perimenopausal patients with MCI by kidney-tonifying, blood-activating, and mind-nourishing.
Methods


80 perimenopausal patients with MCI who met the diagnostic criteria were divided into a therapy group ( n  = 40) and a control group ( n  = 40) according to the treatment method. The control group was given nimodipine (Bayer Pharmaceuticals) 30 mg, 3 times/day orally, while the therapy group was given a decoction of self-prepared Ningshen prescription on the top of the control group (glossy privet fruit, mulberry, aizoon stonecrop, dan-shen root, tuber fleeceflower stem, cyperus rotundus, citron). Patients in the 2 groups were assessed on the MocA scale, ADL scale, and TCM symptom score before and after 2 months of treatment, respectively, to observe whether there was any change in the scale scores and in the levels of inflammatory factors (hs-CRP, Hcy, and IL-1 β ) Pre- and posttherapy in the 2 groups. Observe the improvement of clinical symptoms and their safety in both groups (liver and kidney function indicators such as ALT, AST and Cr, dizziness, headache, decrease in blood pressure, flushing, and gastrointestinal reactions).
Results


The efficacy of the therapy group was better than that of the control group; the MocA scale and ADL scale scores improved and the TCM symptom score decreased in both groups posttherapy, with the MocA scale and ADL scale scores improving more and the TCM symptom score decreasing more in the therapy group compared with the control group during the same period ( p  < 0.05). The serum levels of hs-CRP, Hcy, and IL-1 β  decreased in both groups posttherapy, with the serum levels of hs-CRP, Hcy, and IL-1 β  decreasing more in the therapy group compared to the control group during the same period ( p  < 0.05). The difference in adverse events between the two groups was not statistically significant when compared by a chi-square test ( p  > 0.05). The differences in ALT, AST, and Cr levels between the control group and the treatment group before and after treatment were not significant ( p  > 0.05).
Conclusion


Ning Shen prescription can effectively prevent the continued development of cognitive dysfunction in perimenopausal patients with MCI, delay its natural course, and can improve the patients' ability to perform daily activities and improve their TCM symptoms.",2022,"The serum levels of hs-CRP, Hcy, and IL-1 β  decreased in both groups posttherapy, with the serum levels of hs-CRP, Hcy, and IL-1 β  decreasing more in the therapy group compared to the control group during the same period ( p  < 0.05).","['Perimenopausal Patients with Mild Cognitive Impairment by Self-Prepared Ningshen Prescription', 'perimenopausal patients with MCI', 'perimenopausal patients with MCI by kidney-tonifying, blood-activating, and mind-nourishing', '80 perimenopausal patients with MCI who met the diagnostic criteria']","['nimodipine', 'decoction of self-prepared Ningshen prescription on the top of the control group (glossy privet fruit, mulberry, aizoon stonecrop, dan-shen root, tuber fleeceflower stem, cyperus rotundus, citron']","['ALT, AST and Cr, dizziness, headache, decrease in blood pressure, flushing, and gastrointestinal reactions', 'clinical symptoms', 'Cognitive Function and Inflammatory Response', 'MocA scale and ADL scale scores', 'adverse events', 'MocA scale, ADL scale, and TCM symptom score', 'levels of inflammatory factors (hs-CRP, Hcy, and IL-1 β ) Pre- and posttherapy', 'serum levels of hs-CRP, Hcy, and IL-1 β', 'TCM symptom score', 'ALT, AST, and Cr levels', 'cognitive function and inflammatory response', 'cognitive dysfunction']","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0995160', 'cui_str': 'Genus Ligustrum'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0330540', 'cui_str': 'Morus'}, {'cui': 'C0696940', 'cui_str': 'Salvia miltiorrhizae'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0228487', 'cui_str': 'Cerebellar tuber'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0950026', 'cui_str': 'Cyperus'}, {'cui': 'C1135895', 'cui_str': 'Citron Tree'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",80.0,0.0121376,"The serum levels of hs-CRP, Hcy, and IL-1 β  decreased in both groups posttherapy, with the serum levels of hs-CRP, Hcy, and IL-1 β  decreasing more in the therapy group compared to the control group during the same period ( p  < 0.05).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of TCM, Seventh People's of Shanghai University of TCM, Shanghai 200137, China.""}, {'ForeName': 'Yumei', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': ""Department of TCM, Seventh People's of Shanghai University of TCM, Shanghai 200137, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""Department of TCM, Seventh People's of Shanghai University of TCM, Shanghai 200137, China.""}, {'ForeName': 'Guiyan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""Department of TCM, Seventh People's of Shanghai University of TCM, Shanghai 200137, China.""}, {'ForeName': 'Menghao', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of TCM, Seventh People's of Shanghai University of TCM, Shanghai 200137, China.""}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of TCM, Seventh People's of Shanghai University of TCM, Shanghai 200137, China.""}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/4311031']
1559,35692573,"A Comparative Histomorphometric Analysis of Two Biomaterials for Maxillary Sinus Augmentation: A Randomized Clinical, Crossover, and Split-Mouth Study.","Introduction


Considering oral rehabilitation with dental implants, many studies have aimed at improving bone regeneration through the use of biomaterials.
Objective


This study aimed at comparing bone neoformation in patients undergoing bilateral maxillary sinus surgery with two bovine biomaterials.
Materials and Methods


This is a randomized, blinded, clinical crossover, and divided mouth study. Ten participants with an indication of maxillary sinus enlargement were selected and underwent surgical treatment with Bio-Oss® graft biomaterial (graft 1) on one side and Lumina-Porous® graft biomaterial (graft 2) on the other. The samples were collected after nine months and fixed and then decalcified in 10% ethylenediamine tetra-acetic acid (EDTA) solution for 30 days to process and make histological slides. Connective and bone tissue were further analyzed to identify the amount of newly formed bone.
Results


The graft 1 group had a greater formation of vital mineralized tissue when compared to the graft 2 group ( p  = 0.01). For nonvital mineralized tissue and amount of connective tissue, there was no statistical difference ( p  = 0.21 and  p  = 0.09, respectively). The medullary spaces were larger in the graft 2 group. The group treated with graft 1 presented a higher percentage of osteoclasts and viable osteocytes compared to the graft 2 group ( p  = 0.014 and  p  = 0.027, respectively).
Conclusion


Every day, new alternative biomaterials are offered as an option in oral rehabilitation. In this study, both treatments induced bone neoformation after 9 months; however, the group treated with Bio-Oss® showed a higher percentage of vital mineralized bone tissue.",2022,"The group treated with graft 1 presented a higher percentage of osteoclasts and viable osteocytes compared to the graft 2 group ( p  = 0.014 and  p  = 0.027, respectively).
","['Ten participants with an indication of maxillary sinus enlargement were selected and underwent', 'patients undergoing bilateral maxillary sinus surgery with two bovine biomaterials', 'Two Biomaterials for Maxillary Sinus Augmentation']","['surgical treatment with Bio-Oss® graft biomaterial (graft 1) on one side and Lumina-Porous® graft biomaterial (graft 2', 'ethylenediamine tetra-acetic acid (EDTA) solution']","['bone neoformation', 'percentage of osteoclasts and viable osteocytes', 'medullary spaces', 'formation of vital mineralized tissue', 'vital mineralized bone tissue']","[{'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730608', 'cui_str': 'Bilateral maxillary sinus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0005479', 'cui_str': 'Biomaterials'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0174021', 'cui_str': 'Bio-Oss'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0005479', 'cui_str': 'Biomaterials'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0015091', 'cui_str': 'Ethylenediamine'}, {'cui': 'C1010292', 'cui_str': 'Tetragonopterus'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0029431', 'cui_str': 'Osteoclast'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0029432', 'cui_str': 'Osteocyte'}, {'cui': 'C0001629', 'cui_str': 'Adrenal medulla structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0391978', 'cui_str': 'Bone (tissue) structure'}]",10.0,0.0263922,"The group treated with graft 1 presented a higher percentage of osteoclasts and viable osteocytes compared to the graft 2 group ( p  = 0.014 and  p  = 0.027, respectively).
","[{'ForeName': 'Carlos Ricardo de Queiroz', 'Initials': 'CRQ', 'LastName': 'Martiniano', 'Affiliation': 'São Leopoldo Mandic Institute and Research Center, São Paulo, Brazil.'}, {'ForeName': 'Lídia Audrey Rocha', 'Initials': 'LAR', 'LastName': 'Valadas', 'Affiliation': 'Department of Community and Preventive Dentistry, University of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Jose Ronildo', 'Initials': 'JR', 'LastName': 'Lins do Carmo Filho', 'Affiliation': 'Dentistry and Nursing School, Federal University of Ceara, Fortaleza, Ceara, Brazil.'}, {'ForeName': 'Ana Paula Negreiros Nunes', 'Initials': 'APNN', 'LastName': 'Alves', 'Affiliation': 'Dentistry and Nursing School, Federal University of Ceara, Fortaleza, Ceara, Brazil.'}, {'ForeName': 'Mara Assef', 'Initials': 'MA', 'LastName': 'Leitão Lotif', 'Affiliation': 'Dentistry and Nursing School, Federal University of Ceara, Fortaleza, Ceara, Brazil.'}, {'ForeName': 'Bruno Salles', 'Initials': 'BS', 'LastName': 'Sotto-Maior', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Thereza Cristina Farias Botelho', 'Initials': 'TCFB', 'LastName': 'Dantas', 'Affiliation': 'Paulo Picanço College of Dentistry, Fortaleza, Brazil.'}, {'ForeName': 'Luciane Lacerda Franco Rocha', 'Initials': 'LLFR', 'LastName': 'Rodrigues', 'Affiliation': 'São Leopoldo Mandic Institute and Research Center, São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Francischone', 'Affiliation': 'São Leopoldo Mandic Institute and Research Center, São Paulo, Brazil.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/4577148']
1560,35692571,Effectiveness of Nursing Risk Management in Neonatal Asphyxia Resuscitation Care.,"Objective


To analyze the effectiveness of nursing risk management in neonatal asphyxia resuscitation care and to observe and summarize the nursing measures and outcomes.
Methods


A total of 60 neonatal asphyxia cases from January 2021 to December 2021 were recruited and assigned via a random number table method at a ratio of 1 : 1 to receive either routine care plus nursing risk management (the observation group,  n  = 30) or routine care (the control group,  n  = 30). Outcome measures included blood gas index, neonatal Apgar score, neonatal behavioral neurological assessment (NBNA) score, nursing satisfaction, and complications.
Results


The differences in partial pressure of oxygen (PaO 2 ) and partial pressure of carbon dioxide (PaCO 2 ) between the two groups before care were not statistically significant ( P  > 0.05), while after care, PaO 2  in the observation group had a higher level of PaO 2  and a lower level of PaCO 2  than the control group ( P  < 0.01). The two groups showed similar Apgar scores and NBNA scores before care ( P  > 0.05), while after care, routine care plus nursing risk management resulted in higher Apgar scores and NBNA scores versus routine care alone ( P  < 0.01). The nursing satisfaction rate in the observation group (96.67%) was significantly higher than that of the control group (73.33%) ( P =0.030). Nursing risk management plus routine care was associated with a significantly lower incidence of complications (6.67%) compared to routine care (26.67%) ( P =0.038).
Conclusion


Nursing risk management in neonatal asphyxia resuscitation care showed outstanding outcomes in improving neonatal blood gas index, neurological function, and Apgar score, while reducing the occurrence of complications and achieving high nursing satisfaction.",2022,The nursing satisfaction rate in the observation group (96.67%) was significantly higher than that of the control group (73.33%) ( P =0.030).,"['neonatal asphyxia resuscitation care', '60 neonatal asphyxia cases from January 2021 to December 2021', 'Neonatal Asphyxia Resuscitation Care']","['routine care plus nursing risk management (the observation group,  n \u2009=\u200930) or routine care', 'nursing risk management', 'Nursing Risk Management']","['similar Apgar scores and NBNA scores', 'incidence of complications', 'neonatal blood gas index, neurological function, and Apgar score', 'higher Apgar scores and NBNA scores', 'nursing satisfaction rate', 'partial pressure of oxygen (PaO 2 ) and partial pressure of carbon dioxide (PaCO 2 ', 'blood gas index, neonatal Apgar score, neonatal behavioral neurological assessment (NBNA) score, nursing satisfaction, and complications']","[{'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0035649', 'cui_str': 'Risk management'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}]",2.0,0.0292424,The nursing satisfaction rate in the observation group (96.67%) was significantly higher than that of the control group (73.33%) ( P =0.030).,"[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Delivery Room, People's Hospital of Lujiang County, Lujiang County, Hefei 231500, Anhui Province, China.""}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""People's Hospital of Lujiang County, Lujiang County, Hefei 231500, Anhui Province, China.""}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Sun', 'Affiliation': ""Department of Infectious Diseases, People's Hospital of Lujiang County, Lujiang County, Hefei 231500, Anhui Province, China.""}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/5465472']
1561,35692515,Development of a convolutional neural network to detect abdominal aortic aneurysms.,"Objective


We sought to train a foundational convolutional neural network (CNN) for screening computed tomography (CT) angiography (CTA) scans for the presence of infrarenal abdominal aortic aneurysms (AAAs) for future predictive modeling and other artificial intelligence applications.
Methods


From January 2015 to January 2020, a HIPAA (Health Insurance and Accountability Act)-compliant, institutional review board-approved, retrospective clinical study analyzed contrast-enhanced abdominopelvic CTA scans from 200 patients with infrarenal AAAs and 200 propensity-matched control patients with non-aneurysmal infrarenal abdominal aortas. A CNN was trained to binary classification on the input. For model improvement and testing, transfer learning using the ImageNet database was applied to the VGG-16 base model. The image dataset was randomized to sets of 60%, 10%, and 30% for model training, validation, and testing, respectively. A stochastic gradient descent was used for optimization. The models were assessed by testing validation accuracy and the area under the receiver operating characteristic curve.
Results


Preliminary data demonstrated a nonrandom pattern of accuracy and detectability. Iterations (≤10) of the model characteristics generated a final custom CNN model reporting an accuracy of 99.1% and area under the receiver operating characteristic curve of 0.99. Misjudgments were analyzed through review of the heat maps generated via gradient weighted class activation mapping overlaid on the original CT images. The greatest misjudgments were seen in small aneurysms (<3.3 cm) with mural thrombus.
Conclusions


Preliminary data from a CNN model have shown that the model can accurately screen and identify CTA findings of infrarenal AAAs. This model serves as a proof-of-concept to proceed with potential future directions to include expansion to predictive modeling and other artificial intelligence-based applications.",2022,Iterations (≤10) of the model characteristics generated a final custom CNN model reporting an accuracy of 99.1% and area under the receiver operating characteristic curve of 0.99.,['200 patients with infrarenal AAAs and 200 propensity-matched control patients with non-aneurysmal infrarenal abdominal aortas'],"['train a foundational convolutional neural network (CNN', 'screening computed tomography (CT) angiography (CTA) scans']",['nonrandom pattern of accuracy and detectability'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439651', 'cui_str': 'Aneurysmal'}, {'cui': 'C0003484', 'cui_str': 'Abdominal aorta structure'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0617243,Iterations (≤10) of the model characteristics generated a final custom CNN model reporting an accuracy of 99.1% and area under the receiver operating characteristic curve of 0.99.,"[{'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Camara', 'Affiliation': 'Section of Vascular and Interventional Radiology, Department of Radiology, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Roger T', 'Initials': 'RT', 'LastName': 'Tomihama', 'Affiliation': 'Section of Vascular and Interventional Radiology, Department of Radiology, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pop', 'Affiliation': 'Section of Vascular and Interventional Radiology, Department of Radiology, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Shedd', 'Affiliation': 'Section of Vascular and Interventional Radiology, Department of Radiology, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Brandon S', 'Initials': 'BS', 'LastName': 'Dobrowski', 'Affiliation': 'Section of Vascular and Interventional Radiology, Department of Radiology, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Cole J', 'Initials': 'CJ', 'LastName': 'Knox', 'Affiliation': 'Section of Vascular and Interventional Radiology, Department of Radiology, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abou-Zamzam', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Sharon C', 'Initials': 'SC', 'LastName': 'Kiang', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Linda University School of Medicine, Loma Linda, CA.'}]",Journal of vascular surgery cases and innovative techniques,['10.1016/j.jvscit.2022.04.003']
1562,35692486,Safety and Efficacy of Polymethylmethacrylate-Collagen Gel Filler for Correction of the Pre-jowl Sulcus: A 24-month Prospective Study.,"Background


Polymethylmethacrylate (PMMA)-collagen gel is approved for the correction of nasolabial folds and severe atrophic, distensible facial acne scars on the cheek. However, fillers are often used off-label in clinical practice, necessitating additional study of safety and efficacy.
Objectives


To determine the safety and efficacy of PMMA-collagen gel for the correction of lower face aging, specifically the pre-jowl sulcus.
Methods


In this prospective, single-center, 1-year study (N = 20) and additional 1-year extension (N = 10), 20 patients with a pretreatment score of 2, 3, or 4 on the 5-point Merz Aesthetic Scale for jawline at rest were eligible for treatment with PMMA-collagen gel. Efficacy was measured by blinded review using the jawline scale, Subject and Physician Global Aesthetic Improvement Scale (GAIS) and Subject Satisfaction scores, collected at weeks 4, 12, 26, 52, and 104.
Results


Improvement in jawline score was significant at all posttreatment time points up to 104 weeks ( P  < 0.01). The percentage of patients with subject-reported GAIS ratings of ""improved"" or ""much improved"" was 79% at 12 weeks and ratings were maintained at 76% at 52 weeks and increased to 90% at week 104. At 52 and 104 weeks, 82% and 100% of patients, respectively, were at least ""somewhat satisfied."" All adverse events were minor.
Conclusions


PMMA-collagen gel is well tolerated and effective for durable correction of the pre-jowl sulcus and jawline.
Level of Evidence 4


",2022,"Results


Improvement in jawline score was significant at all posttreatment time points up to 104 weeks ( P  < 0.01).","['Pre-jowl Sulcus', '20 patients with a pretreatment score of 2, 3, or 4 on the 5-point Merz Aesthetic Scale for jawline at rest were eligible for treatment with']","['PMMA-collagen gel', 'Polymethylmethacrylate-Collagen Gel Filler', '\n\n\nPolymethylmethacrylate (PMMA)-collagen gel']","['jawline score', 'GAIS ratings of ""improved"" or ""much improved', 'Efficacy', 'Safety and Efficacy', 'jawline scale, Subject and Physician Global Aesthetic Improvement Scale (GAIS) and Subject Satisfaction scores']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005533', 'cui_str': 'Polymethyl methacrylate'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0729441', 'cui_str': 'Filler'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",20.0,0.0355922,"Results


Improvement in jawline score was significant at all posttreatment time points up to 104 weeks ( P  < 0.01).","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Hevia', 'Affiliation': ''}]",Aesthetic surgery journal. Open forum,['10.1093/asjof/ojac030']
1563,35692457,The effectiveness of high-flow nasal cannula and standard non-rebreathing mask for oxygen therapy in moderate category COVID-19 pneumonia: Randomised controlled trial.,"Background


COVID-19 caused by the highly infectious severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection is a matter of concern and has led to severe health problems all over the world. Oxygen therapy is the mainstay for the management of patients suffering from various stages of the disease.
Objectives


To compare the effectiveness of high-flow nasal cannula (HFNC) and standard non-rebreathing mask (NRBM) as oxygen delivery devices in moderate cases of COVID-19 pneumonia.
Methods


A single-centre, open-label, randomised controlled trial was conducted between February 2021 and April 2021. All the enrolled patients (N=120) were randomly allocated into two groups according to the oxygen delivery device used. Group 1 (n=60) received HFNC and group 2 (n=60) received NRBM as the initial oxygen delivery device, to maintain a target saturation ≥96% in both groups. The progression-free survival without escalation of respiratory support, partial pressure of arterial oxygen (PaO 2  ), a ratio of partial pressure of arterial oxygen to fractional inspiratory oxygen concentration (PaO 2  /FiO 2  ), respiratory rate, heart rate, blood pressure, number of patients requiring non-invasive ventilation or endotracheal intubation, time for de-escalation of oxygen therapy to lower FiO 2  device, time to progression to severe disease, survival at day 28, and patient satisfaction level were compared between the two groups.
Results


Demographic, clinical variables and treatment received were comparable in the two groups. In the HFNC group, 90% of patients had successful outcomes with the initial oxygen therapy device used as compared with 56.6% in the NRBM group (p<0.001; odds ratio (OR) 0.145; 95% confidence interval (CI) 0.054 - 0.389). Using HFNC also resulted in improved oxygenation (PaO 2  /FiO 2  ) (p<0.001), better patient satisfaction (p<0.001), and a shorter time for de-escalation of oxygen therapy to a lower FiO 2  device (p<0.001). The 28-day survival was higher in the HFNC group, but the difference was statistically insignificant (p=0.468).
Conclusion


HFNC is a reliable oxygen therapy modality for moderate category COVID-19 pneumonia and results in a higher success rate of oxygen therapy, better oxygenation, and a greater patient satisfaction level as compared with a NRBM.",2022,"Using HFNC also resulted in improved oxygenation (PaO 2  /FiO 2  ) (p<0.001), better patient satisfaction (p<0.001), and a shorter time for de-escalation of oxygen therapy to a lower FiO 2  device (p<0.001).","['moderate cases of COVID-19 pneumonia', 'patients suffering from various stages of the disease', 'enrolled patients (N=120', 'February 2021 and April 2021', 'moderate category COVID-19 pneumonia']","['NRBM', 'HFNC', 'high-flow nasal cannula (HFNC) and standard non-rebreathing mask (NRBM', 'high-flow nasal cannula and standard non-rebreathing mask for oxygen therapy', 'Oxygen therapy']","['28-day survival', 'progression-free survival without escalation of respiratory support, partial pressure of arterial oxygen (PaO 2  ), a ratio of partial pressure of arterial oxygen to fractional inspiratory oxygen concentration (PaO 2  /FiO 2  ), respiratory rate, heart rate, blood pressure, number of patients requiring non-invasive ventilation or endotracheal intubation, time for de-escalation of oxygen therapy to lower FiO 2  device, time to progression to severe disease, survival at day 28, and patient satisfaction level', 'successful outcomes']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.212354,"Using HFNC also resulted in improved oxygenation (PaO 2  /FiO 2  ) (p<0.001), better patient satisfaction (p<0.001), and a shorter time for de-escalation of oxygen therapy to a lower FiO 2  device (p<0.001).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nazir', 'Affiliation': 'Department of Anesthesiology and Critical Care, Government Institute of Medical Sciences, Greater Noida, Uttar Pradesh, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Anesthesiology and Critical Care, Government Institute of Medical Sciences, Greater Noida, Uttar Pradesh, India.'}]",African journal of thoracic and critical care medicine,['10.7196/AJTCCM.2022.v28i1.206']
1564,35692449,Precision medicine for acute pancreatitis: current status and future opportunities.,"Acute pancreatitis is a common inflammatory condition affecting the pancreas, predominantly caused by gallstones, alcohol excess, and hypertriglyceridaemia, with severe disease carrying up to 50% mortality. Despite significant research and preclinical promise, no targeted drug treatments exist for the disease and precision medicine approaches are lacking significantly, when compared to other health conditions. Advances in omics applications will facilitate improved preclinical models and target identification as well as biomarker discovery for refined trial design, focusing on risk stratification, subject selection, and outcome determination. Randomised treatment of Acute Pancreatitis with Infliximab: Double-blind, placebo-controlled, multi-centre trial (RAPID-I) is a pioneering trial, currently under way in acute pancreatitis, which may serve as an innovative model for the implementation of precision medicine strategies for acute pancreatitis in the future.",2019,"Advances in omics applications will facilitate improved preclinical models and target identification as well as biomarker discovery for refined trial design, focusing on risk stratification, subject selection, and outcome determination.",['acute pancreatitis'],"['Infliximab', 'placebo']",[],"[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.111603,"Advances in omics applications will facilitate improved preclinical models and target identification as well as biomarker discovery for refined trial design, focusing on risk stratification, subject selection, and outcome determination.","[{'ForeName': 'Rajarshi', 'Initials': 'R', 'LastName': 'Mukherjee', 'Affiliation': 'Liverpool Pancreatitis Research Group, Royal Liverpool University Hospital and Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Nunes', 'Affiliation': 'Liverpool Pancreatitis Research Group, Royal Liverpool University Hospital and Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Liverpool Pancreatitis Research Group, Royal Liverpool University Hospital and Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sutton', 'Affiliation': 'Liverpool Pancreatitis Research Group, Royal Liverpool University Hospital and Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}]",Precision clinical medicine,['10.1093/pcmedi/pbz010']
1565,35692440,Sedentary Behaviour Intervention as a Personalised Secondary Prevention Strategy (SIT LESS) for patients with coronary artery disease participating in cardiac rehabilitation: rationale and design of the SIT LESS randomised clinical trial.,"Patients with coronary artery disease (CAD) are more sedentary compared with the general population, but contemporary cardiac rehabilitation (CR) programmes do not specifically target sedentary behaviour (SB). We developed a 12-week, hybrid (centre-based+home-based) Sedentary behaviour IntervenTion as a personaLisEd Secondary prevention Strategy (SIT LESS). The SIT LESS programme is tailored to the needs of patients with CAD, using evidence-based behavioural change methods and an activity tracker connected to an online dashboard to enable self-monitoring and remote coaching. Following the intervention mapping principles, we first identified determinants of SB from literature to adapt theory-based methods and practical applications to target SB and then evaluated the intervention in advisory board meetings with patients and nurse specialists. This resulted in four core components of SIT LESS: (1) patient education, (2) goal setting, (3) motivational interviewing with coping planning, and (4) (tele)monitoring using a pocket-worn activity tracker connected to a smartphone application and providing vibrotactile feedback after prolonged sedentary bouts. We hypothesise that adding SIT LESS to contemporary CR will reduce SB in patients with CAD to a greater extent compared with usual care. Therefore, 212 patients with CAD will be recruited from two Dutch hospitals and randomised to CR (control) or CR+SIT LESS (intervention). Patients will be assessed prior to, immediately after and 3 months after CR. The primary comparison relates to the pre-CR versus post-CR difference in SB (objectively assessed in min/day) between the control and intervention groups. Secondary outcomes include between-group differences in SB characteristics (eg, number of sedentary bouts); change in SB 3 months after CR; changes in light-intensity and moderate-to-vigorous-intensity physical activity; quality of life; and patients' competencies for self-management. Outcomes of the SIT LESS randomised clinical trial will provide novel insight into the effectiveness of a structured, hybrid and personalised behaviour change intervention to attenuate SB in patients with CAD participating in CR. Trial registration number NL9263.",2022,We hypothesise that adding SIT LESS to contemporary CR will reduce SB in patients with CAD to a greater extent compared with usual care.,"['patients with CAD', 'patients with coronary artery disease participating in cardiac rehabilitation', '212 patients with CAD will be recruited from two Dutch hospitals and randomised to CR (control) or CR+SIT\u2009LESS (intervention', 'patients with CAD participating in CR', 'Patients with coronary artery disease (CAD']","['Sedentary Behaviour Intervention', 'Personalised Secondary Prevention Strategy (SIT LESS', 'Sedentary behaviour IntervenTion', 'motivational interviewing with coping planning, and (4) (tele)monitoring using a pocket-worn activity tracker connected to a smartphone application and providing vibrotactile feedback after prolonged sedentary bouts', 'hybrid (centre-based+home-based']","[""SB characteristics (eg, number of sedentary bouts); change in SB 3\u2009months after CR; changes in light-intensity and moderate-to-vigorous-intensity physical activity; quality of life; and patients' competencies for self-management""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0679699', 'cui_str': 'Secondary prevention'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]",212.0,0.0243782,We hypothesise that adding SIT LESS to contemporary CR will reduce SB in patients with CAD to a greater extent compared with usual care.,"[{'ForeName': 'B M A', 'Initials': 'BMA', 'LastName': 'van Bakel', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Kroesen', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Günal', 'Affiliation': 'Department of Cardiology, Bernhoven Hospital, Uden, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Scheepmaker', 'Affiliation': 'Department of Cardiology, Bernhoven Hospital, Uden, The Netherlands.'}, {'ForeName': 'W R M', 'Initials': 'WRM', 'LastName': 'Aengevaeren', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'F F', 'Initials': 'FF', 'LastName': 'Willems', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wondergem', 'Affiliation': 'Department of Rehabilitation, Physical Therapy Science and Sport, University Medical Center Utrecht Brain Center, Utrecht, The Netherlands.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Pisters', 'Affiliation': 'Department of Rehabilitation, Physical Therapy Science and Sport, University Medical Center Utrecht Brain Center, Utrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dam', 'Affiliation': 'Department of IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Janssen', 'Affiliation': 'Department of IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Bruin', 'Affiliation': 'Department of IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'M T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'D H J', 'Initials': 'DHJ', 'LastName': 'Thijssen', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands.'}, {'ForeName': 'T M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2022-001364']
1566,35692398,Radiomics Analysis of Computed Tomography for Prediction of Thyroid Capsule Invasion in Papillary Thyroid Carcinoma: A Multi-Classifier and Two-Center Study.,"Objective


To investigate the application of computed tomography (CT)-based radiomics model for prediction of thyroid capsule invasion (TCI) in papillary thyroid carcinoma (PTC).
Methods


This retrospective study recruited 412 consecutive PTC patients from two independent institutions and randomly assigned to training (n=265), internal test (n=114) and external test (n=33) cohorts. Radiomics features were extracted from non-contrast (NC) and artery phase (AP) CT scans. We also calculated delta radiomics features, which are defined as the absolute differences between the extracted radiomics features. One-way analysis of variance and least absolute shrinkage and selection operator were used to select optimal radiomics features. Then, six supervised machine learning radiomics models (k-nearest neighbor, logistic regression, decision tree, linear support vector machine [L-SVM], Gaussian-SVM, and polynomial-SVM) were constructed. Univariate was used to select clinicoradiological risk factors. Combined models including optimal radiomics features and clinicoradiological risk factors were constructed by these six classifiers. The prediction performance was evaluated using the receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis (DCA).
Results


In the internal test cohort, the best combined model (L-SVM, AUC=0.820 [95% CI 0.758-0.888]) performed better than the best radiomics model (L-SVM, AUC = 0.733 [95% CI 0.654-0.812]) and the clinical model (AUC = 0.709 [95% CI 0.649-0.783]). Combined-L-SVM model combines 23 radiomics features and 1 clinicoradiological risk factor (CT-reported TCI). In the external test cohort, the AUC was 0.776 (0.625-0.904) in the combined-L-SVM model, showing that the model is stable. DCA demonstrated that the combined model was clinically useful.
Conclusions


Our combined model based on machine learning incorporated with CT radiomics features and the clinicoradiological risk factor shows good predictive ability for TCI in PTC.",2022,"In the external test cohort, the AUC was 0.776 (0.625-0.904) in the combined-L-SVM model, showing that the model is stable.","['Papillary Thyroid Carcinoma', '412 consecutive PTC patients from two independent institutions and randomly assigned to training (n=265), internal test (n=114) and external test (n=33) cohorts', 'papillary thyroid carcinoma (PTC']","['computed tomography (CT)-based radiomics model', 'DCA', 'Computed Tomography']","['receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis (DCA']","[{'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",412.0,0.050724,"In the external test cohort, the AUC was 0.776 (0.625-0.904) in the combined-L-SVM model, showing that the model is stable.","[{'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Pengyi', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Mao', 'Affiliation': 'Department of Radiology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Kaili', 'Initials': 'K', 'LastName': 'Che', 'Affiliation': 'Department of Radiology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Guan', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Haicheng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Big Data and Artificial Intelligence Laboratory, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Yakui', 'Initials': 'Y', 'LastName': 'Mou', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}, {'ForeName': 'Xicheng', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2022.849065']
1567,35692380,The Impact of Aerobic Exercise on Mood Symptoms in Trauma-Exposed Young Adults: A Pilot Study.,"Introduction


Physical activity has beneficial effects on mood in both healthy and clinical populations. Emerging literature suggests that physical activity may benefit psychological symptoms, such as depressive mood, in those with post-traumatic stress disorder (PTSD). It is estimated that 76% of Canadians have experienced a traumatic event during their lifetime (Van Ameringen et al., 2008). Thus, there is a large proportion of the population that does not meet criteria for PTSD but may still suffer from trauma-related symptoms such as depression and require support for their mental health. The current pilot study aimed to evaluate the impact of an aerobic exercise intervention on mood symptoms in trauma-exposed young adults.
Methods


Twenty-five low active young adults with subclinical trauma symptoms but no current or past diagnosis of PTSD were recruited. Participants were randomly assigned to participate in an 8-week exercise intervention group or a waitlist control group. Mood symptoms were assessed before and after the intervention. In addition, measures of aerobic fitness, trauma symptoms, emotion regulation, and trait mindfulness were assessed at both time points.
Results


The exercise intervention was effective at inducing the expected improvements in aerobic fitness. Overall, the exercise group had a significantly greater decrease in mood symptoms across the intervention compared to the waitlist control group.
Conclusion


The current pilot study is the first to evaluate the impact of aerobic exercise on mood in trauma-exposed young adults. An 8-week intervention significantly reduced mood symptoms in exercisers relative to waitlist controls. Our results are consistent with previous research indicating that physical activity reduced depressive symptoms in those with PTSD (Rosenbaum et al., 2015b). Importantly, we extend these findings to individuals with subclinical or undiagnosed PTSD symptoms, where exercise may be an effective intervention to improve mood and manage or prevent further decline in mental health in those at risk of developing PTSD.",2022,"Overall, the exercise group had a significantly greater decrease in mood symptoms across the intervention compared to the waitlist control group.
","['trauma-exposed young adults', 'individuals with subclinical or undiagnosed PTSD symptoms', 'Trauma-Exposed Young Adults', 'Methods\n\n\nTwenty-five low active young adults with subclinical trauma symptoms but no current or past diagnosis of PTSD were recruited']","['Aerobic Exercise', 'aerobic exercise', 'exercise intervention', 'exercise intervention group or a waitlist control group', 'aerobic exercise intervention']","['depressive symptoms', 'aerobic fitness, trauma symptoms, emotion regulation, and trait mindfulness', 'mood symptoms', 'aerobic fitness', 'Mood symptoms', 'Mood Symptoms']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1444635', 'cui_str': 'Current or past'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",25.0,0.0083146,"Overall, the exercise group had a significantly greater decrease in mood symptoms across the intervention compared to the waitlist control group.
","[{'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Mizzi', 'Affiliation': 'Department of Psychology, Neuroscience and Behaviour, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'McKinnon', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, Neuroscience and Behaviour, McMaster University, Hamilton, ON, Canada.'}]",Frontiers in behavioral neuroscience,['10.3389/fnbeh.2022.829571']
1568,35692813,Prediction of Prognosis and Immunotherapy of Osteosarcoma Based on Necroptosis-Related lncRNAs.,"Background:  Osteosarcoma (OS) is the most common primary tumor of bone in adolescents, and its survival rate is generally less than 20% when metastases occur. Necroptosis, a novel form of programmed necrotic cell death distinct from apoptosis, has been increasingly recognized as a promising therapeutic strategy. This study sought to identify long non-coding RNAs (lncRNAs) associated with necrotizing apoptosis to predict prognosis and target drug use to improve patient survival.  Methods:  Transcriptomic data and clinical data from 85 OS patients with survival time data and expression profiles from 85 random normal adipose tissue samples were extracted from the UCSC Xena website (http://xena.ucsc.edu/). Nine necroptosis-associated differential prognostic lncRNAs were then identified by analysis of variance, correlation analysis, univariate Cox (uni-Cox) regression, and Kaplan-Meier analysis. Then, patients were randomized into training or testing groups. According to uni-Cox, we obtained prognostic lncRNAs in the training group and intersected them with the abovementioned nine lncRNAs to obtain the final necrotizing apoptosis-related differential prognostic lncRNAs (NRlncRNAs). Next, we performed the least absolute shrinkage and selection operator (LASSO) to construct a risk model of NRlncRNAs. Kaplan-Meier analysis, ROC curves, nomograms, calibration curves, and PCA were used to validate and evaluate the models and grouping. We also analyzed the differences in tumor immunity and drugs between risk groups.  Results:  We constructed a model containing three NRlncRNAs (AL391121.1, AL354919.2, and AP000851.2) and validated its prognostic predictive power. The value of the AUC curve of 1-, 3-, and 5-year survival probability was 0.806, 0.728, and 0.731, respectively. Moreover, we found that the overall survival time of patients in the high-risk group was shorter than that in the low-risk group. GSEA and ssGSEA showed that immune-related pathways were mainly abundant in the low-risk group. We also validated the differential prediction of immune checkpoint expression, tumor immunity, and therapeutic compounds in the two risk groups.  Conclusion:  Overall, NRlncRNAs have important functions in OS, and these three NRlncRNAs can predict the prognosis of OS and provide guidance for immunotherapy in OS.",2022,"The value of the AUC curve of 1-, 3-, and 5-year survival probability was 0.806, 0.728, and 0.731, respectively.",['85 OS patients with survival time data and expression profiles from 85 random normal adipose tissue samples were extracted from the UCSC Xena website (http://xena.ucsc.edu'],[],"['survival rate', 'overall survival time', 'Kaplan-Meier analysis, ROC curves, nomograms, calibration curves, and PCA', 'AUC curve of 1-, 3-, and 5-year survival probability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0586544', 'cui_str': 'Adipose tissue sample'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",85.0,0.0503072,"The value of the AUC curve of 1-, 3-, and 5-year survival probability was 0.806, 0.728, and 0.731, respectively.","[{'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Wanjiang', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopedics, Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jianlong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Third Xiangya Hospital, Central South University, Changsha, China.'}]",Frontiers in genetics,['10.3389/fgene.2022.917935']
1569,35692738,Is Early Preventive Caffeine Safe and Effective in Premature Neonates? A Clinical Trial.,"Background


Advantages of caffeine for the treatment of apnea of prematurity (AOP) have prompted clinicians to use it as a preventive drug even before the occurrence of apnea.
Objective


To compare the effect of early preventive caffeine therapy with routine late preventive caffeine on the occurrence rate of apnea of prematurity, bronchopulmonary dysplasia (BPD) and related radiographic changes, necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), and patent ductus arteriosus (PDA), the need for mechanical ventilation, the length of mechanical ventilation, and the length of hospitalization.
Materials and Methods


In this open randomized clinical trial study, 90 preterm neonates with the gestational age of 25-35 weeks were divided into 2 groups: group A received caffeine during the first two days of life (early preventive caffeine), while group B received caffeine during the third to the tenth day of life (late preventive caffeine). The occurrence rate of AOP and other outcomes were the primary outcomes. The adverse effects of caffeine in each group were the secondary outcomes.
Results


The total occurrence rate of AOP was significantly higher (32.6%) in the late group versus (6.8%) in the early group ( p  = 0.002). The total occurrence rate of BPD was also significantly higher (37%) in the late group versus (18.2%) in the early group ( p  = 0.047). On the other hand, we found a lower need for mechanical ventilation, shorter length of mechanical ventilation, shorter length of hospitalization, and a lower occurrence rate of PDA, NEC, and IVH in the early group that was not significant. No adverse effect of caffeine was observed in each group.
Conclusions


Early preventive caffeine administration was associated with a significantly lower occurrence rate of AOP, BPD, and BPD radiologic changes. As other outcomes occurred lesser in the early group that were not significant, future studies with more participants are recommended. This study has been registered at the Iranian Registry of Clinical Trials (IRCT20160827029535N8).",2022,The total occurrence rate of AOP was significantly higher (32.6%) in the late group versus (6.8%) in the early group ( p  = 0.002).,"['Premature Neonates', 'apnea of prematurity (AOP', '90 preterm neonates with the gestational age of 25-35 weeks']","['caffeine during the first two days of life (early preventive caffeine', 'caffeine', 'early preventive caffeine therapy with routine late preventive caffeine']","['mechanical ventilation, shorter length of mechanical ventilation, shorter length of hospitalization, and a lower occurrence rate of PDA, NEC, and IVH', 'occurrence rate of AOP, BPD, and BPD radiologic changes', 'occurrence rate of AOP', 'adverse effects', 'occurrence rate of apnea of prematurity, bronchopulmonary dysplasia (BPD) and related radiographic changes, necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), and patent ductus arteriosus (PDA), the need for mechanical ventilation, the length of mechanical ventilation, and the length of hospitalization', 'total occurrence rate of AOP', 'total occurrence rate of BPD']","[{'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",90.0,0.111917,The total occurrence rate of AOP was significantly higher (32.6%) in the late group versus (6.8%) in the early group ( p  = 0.002).,"[{'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Sajjadian', 'Affiliation': 'Tehran University of Medical Sciences, Shariati Hospital, Tehran, Iran.'}, {'ForeName': 'Peymaneh Alizadeh', 'Initials': 'PA', 'LastName': 'Taheri', 'Affiliation': 'Tehran University of Medical Sciences, Bahrami Children Hospital, Tehran, Iran.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Jabbari', 'Affiliation': 'Tehran University of Medical Sciences, Bahrami Children Hospital, Tehran, Iran.'}]",International journal of pediatrics,['10.1155/2022/8701598']
1570,35692672,Effect of matcha consumption on gut microbiota in healthy Japanese individuals: study protocol for a double-blind crossover interventional study.,"This study compares and clarifies the changes in intestinal flora resulting from the continuous consumption of two types of matcha. Healthy adults will consume two types of matcha tea for four weeks, and differences in the intestinal microflora before and after drinking will be compared. Gut microbiota will be identified using next-generation sequencing. Phylogenetic classification of the enterobacteria will be performed based on sequence similarities. The relative proportions of the classified enterobacteria to the total nucleotide sequences will be compared between the samples obtained from the two groups consuming different matcha. The continuous consumption of matcha may improve dysbiosis and prevent atherosclerosis. The effects may vary according to the type of matcha used. Trial registration: The study was registered with university hospital medical information network (UMIN) (UMIN000040303), and all participants gave their written informed consent. Registered 1 November 2020, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000045982.",2022,The relative proportions of the classified enterobacteria to the total nucleotide sequences will be compared between the samples obtained from the two groups consuming different matcha.,"['Healthy adults', 'healthy Japanese individuals']",['matcha consumption'],['gut microbiota'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.107174,The relative proportions of the classified enterobacteria to the total nucleotide sequences will be compared between the samples obtained from the two groups consuming different matcha.,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Takegami', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Munekawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Nakajima', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Nakanishi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kitao', 'Affiliation': 'Tea Industry Research Division, Kyoto Prefectural Agriculture, Forestry and Fisheries Technology Center, 1 Nakanosono, Shirakawa, Uji, Kyoto 611-0022, Japan.'}, {'ForeName': 'Kazutsugu', 'Initials': 'K', 'LastName': 'Kinoshita', 'Affiliation': 'Tea Industry Research Division, Kyoto Prefectural Agriculture, Forestry and Fisheries Technology Center, 1 Nakanosono, Shirakawa, Uji, Kyoto 611-0022, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}]",Journal of clinical biochemistry and nutrition,['10.3164/jcbn.21-110']
1571,35693031,The Effect of a Brief Mindfulness Practice on Perceived Stress and Sustained Attention: Does Priming Matter?,"Objectives


The objective of the current study was to investigate the effect of a brief mindfulness practice on perceived stress and sustained attention, and to determine whether priming the benefits of mindfulness meditation enhances this effect.
Methods


Two hundred and twenty undergraduate students were randomly assigned to a control condition (CC), a meditation condition (MC), or a priming + meditation condition (PMC). Baseline and post-treatment measures included subjective stress ratings on a visual analog scale (VAS) and performance on a Sustained Attention to Response Task (SART), determined by reaction time coefficient of variability (RTCV) and three measures of accuracy: correct responses, errors of commission, and errors of omission.
Results


Repeated measures analyses revealed that both the MC and the PMC displayed a decline in perceived stress relative to the CC. Analyses further revelated that the MC and PMC displayed fewer errors of omission relative to the CC. However, only the PMC displayed better performance relative to the CC with respect to total correct response and errors of commission. There were no significant between-group differences for RTCV.
Conclusions


These findings are novel and provide a foundation to further investigate the effect of priming on mindfulness engagement and its potential benefits.
Supplementary Information


The online version contains supplementary material available at 10.1007/s12671-022-01913-8.",2022,"Results


Repeated measures analyses revealed that both the MC and the PMC displayed a decline in perceived stress relative to the CC.",['Two hundred and twenty undergraduate students'],"['Brief Mindfulness Practice', 'mindfulness meditation', 'control condition (CC), a meditation condition (MC), or a priming\u2009+\u2009meditation condition (PMC']","['subjective stress ratings on a visual analog scale (VAS) and performance on a Sustained Attention to Response Task (SART), determined by reaction time coefficient of variability (RTCV) and three measures of accuracy: correct responses, errors of commission, and errors of omission']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.0667982,"Results


Repeated measures analyses revealed that both the MC and the PMC displayed a decline in perceived stress relative to the CC.","[{'ForeName': 'Rhiannon Y', 'Initials': 'RY', 'LastName': 'Ueberholz', 'Affiliation': 'Institute for Stress and Wellbeing Research, Department of Psychology, Toronto Metropolitan University, 350 Victoria St, Toronto, ON M5B 2K3 Canada.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Fiocco', 'Affiliation': 'Institute for Stress and Wellbeing Research, Department of Psychology, Toronto Metropolitan University, 350 Victoria St, Toronto, ON M5B 2K3 Canada.'}]",Mindfulness,['10.1007/s12671-022-01913-8']
1572,35692989,Intervening with Opioid-Exposed Newborns:: Modifying an Evidence-Based Parenting Intervention.,"Background


Prenatal opioid exposure predisposes infants to adverse development of regulatory systems and jeopardizes their long-term health outcomes. While sensitive caregiving promotes healthy development of emotional and physiological regulation and may remediate risks associated with prenatal opioid exposure, mothers with opioid use disorder often experience unique challenges that make providing sensitive care difficult.
Rationale


Empirically tested early interventions, such as the Attachment and Biobehavioral Catch-up (ABC) intervention, can positively impact children's development following adversity through promoting sensitive caregiving. ABC intervention targets correspond to those parenting behaviors that may be challenging for mothers with opioid use disorder (i.e., nurturing infants who may be difficult to soothe, responding sensitively to infants by following the child's lead with delight, and avoiding intrusive/frightening behavior), and have positive impacts on child development and regulation. However, given the unique challenges for infants and mothers impacted by opioid use, some adaptations may strategically address those vulnerabilities and thereby maximize the potential benefits for this population.
Methods


The present paper describes modifications made to the ABC intervention for use with pregnant mothers in treatment for opioid use disorder. This modified intervention is currently being examined via a large scale randomized clinical trial (RCT) at the University of Delaware, and a case study is presented here to highlight considerations for working with mothers and infants impacted by opioid use and to exemplify ways that modified ABC addresses the needs of this population.",2022,"Background


Prenatal opioid exposure predisposes infants to adverse development of regulatory systems and jeopardizes their long-term health outcomes.",['pregnant mothers in treatment for opioid use disorder'],"['Biobehavioral Catch-up (ABC) intervention', 'ABC intervention']",[],"[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0237528,"Background


Prenatal opioid exposure predisposes infants to adverse development of regulatory systems and jeopardizes their long-term health outcomes.","[{'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'Doctoral Candidate, Clinical Psychology, University of Delaware.'}, {'ForeName': 'Hung-Wei Bernie', 'Initials': 'HB', 'LastName': 'Chen', 'Affiliation': 'University of Delaware.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Unidel Amy Elizabeth du Pont Chair in Child Development, University of Delaware.'}]",Delaware journal of public health,['10.32481/djph.2022.05.014']
1573,35692982,"Is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? Study protocol of the multicentre, non-inferiority Antarctica-2 randomised controlled trial.","STUDY QUESTION


The objective of this trial is to compare the effectiveness and costs of true natural cycle (true NC-) frozen embryo transfer (FET) using urinary LH tests to modified NC-FET using repeated ultrasound monitoring and ovulation trigger to time FET in the NC. Secondary outcomes are the cancellation rates of FET (ovulation before hCG or no dominant follicle, no ovulation by LH urine test, poor embryo survival), pregnancy outcomes (miscarriage rate, clinical pregnancy rates, multiple ongoing pregnancy rates, live birth rates, costs) and neonatal outcomes (including gestational age, birthweight and sex, congenital abnormalities or diseases of babies born).
WHAT IS KNOWN ALREADY


FET is at the heart of modern IVF. To allow implantation of the thawed embryo, the endometrium must be prepared either by exogenous oestrogen and progesterone supplementation (artificial cycle (AC)-FET) or by using the NC to produce endogenous oestradiol before and progesterone after ovulation to time the transfer of the thawed embryo (NC-FET). During an NC-FET, women visit the hospital repeatedly and receive an ovulation trigger to time FET (i.e. modified (m)NC-FET or hospital-based monitoring). From the woman's point of view, a more natural approach using home-based monitoring of the ovulation with LH urine tests to allow a natural ovulation to time FET may be desired (true NC-FET or home-based monitoring).
STUDY DESIGN SIZE DURATION


This is a multicentre, non-inferiority prospective randomised controlled trial design. Consenting women will undergo one FET cycle using either true NC-FET or mNC-FET based on randomisation.
PARTICIPANTS/MATERIALS SETTING METHODS


Based on our sample size calculation, the study group will consist of 1464 women between 18 and 45 years old who are scheduled for FET. Women with anovulatory cycles, women who need ovulation induction and women with a contra indication for pregnancy will be excluded. The primary outcome is ongoing pregnancy. Secondary outcomes are cancellation rates of FET, pregnancy outcomes (including miscarriage rate, clinical pregnancy, multiple pregnancy rate and live birth rate). Costs will be estimated by counting resource use and calculating unit prices.
STUDY FUNDING/COMPETING INTERESTS


The study received a grant from the Dutch Organisation for Health Research and Development (ZonMw 843002807; www.zonmw.nl). ZonMw has no role in the design of the study, collection, analysis, and interpretation of data or writing of the manuscript. F.B. reports personal fees from member of the external advisory board for Merck Serono, grants from Research support grant Merck Serono, outside the submitted work. A.E.P.C. reports and Unrestricted grant of Ferring B.V. to the Center for Reproductive medicine, no personal fee. Author up-to-date on Hyperthecosis. Congress meetings 2019 with Ferring B.V. and Theramex B.V. M.G. reports Department research and educational grants from Guerbet, Merck and Ferring (location VUMC) outside the submitted work. E.R.G. reports personal fees from Titus Health Care, outside the submitted work. C.B.L. reports grants from Ferring, grants from Merck, from Guerbet, outside the submitted work. The other authors have none to declare.
TRIAL REGISTRATION NUMBER


Dutch Trial Register (Trial NL6414 (NTR6590), https://www.trialregister.nl/).
TRIAL REGISTRATION DATE


23 July 2017.
DATE OF FIRST PATIENT’S ENROLMENT


10 April 2018.",2021,"Secondary outcomes are the cancellation rates of FET (ovulation before hCG or no dominant follicle, no ovulation by LH urine test, poor embryo survival), pregnancy outcomes (miscarriage rate, clinical pregnancy rates, multiple ongoing pregnancy rates, live birth rates, costs) and neonatal outcomes (including gestational age, birthweight and sex, congenital abnormalities or diseases of babies born).
","['Consenting women will undergo one FET cycle using either true NC-FET or mNC-FET based on randomisation', '23 July 2017', 'Women with anovulatory cycles, women who need ovulation induction and women with a contra indication for pregnancy will be excluded', '1464 women between 18 and 45 years old who are scheduled for FET']","['true natural cycle (true NC-) frozen embryo transfer (FET', 'exogenous oestrogen and progesterone supplementation (artificial cycle (AC)-FET', 'SIZE']","['cancellation rates of FET, pregnancy outcomes (including miscarriage rate, clinical pregnancy, multiple pregnancy rate and live birth rate', 'cancellation rates of FET (ovulation before hCG or no dominant follicle, no ovulation by LH urine test, poor embryo survival), pregnancy outcomes (miscarriage rate, clinical pregnancy rates, multiple ongoing pregnancy rates, live birth rates, costs) and neonatal outcomes (including gestational age, birthweight and sex, congenital abnormalities or diseases of babies born']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",1464.0,0.17957,"Secondary outcomes are the cancellation rates of FET (ovulation before hCG or no dominant follicle, no ovulation by LH urine test, poor embryo survival), pregnancy outcomes (miscarriage rate, clinical pregnancy rates, multiple ongoing pregnancy rates, live birth rates, costs) and neonatal outcomes (including gestational age, birthweight and sex, congenital abnormalities or diseases of babies born).
","[{'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Zaat', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Baal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Flevo ziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Benneheij', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Brandes', 'Affiliation': 'Center for Reproductive Medicine Nij Geertgen, Elsendorp, The Netherland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Broekmans', 'Affiliation': 'Department of Reproductive Medicine, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'A E P', 'Initials': 'AEP', 'LastName': 'Cantineau', 'Affiliation': 'Center for Reproductive Medicine, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cohlen', 'Affiliation': 'Isala Fertility Centre, Isala Clinics, Zwolle, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Disseldorp', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'S C J P', 'Initials': 'SCJP', 'LastName': 'Gielen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Franciscus Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Groenewoud', 'Affiliation': 'Department of Obstetrics and Gynaecology, Noordwest Ziekenhuisgroep, Den Helder, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van Heusden', 'Affiliation': 'TFP Medisch Centrum Kinderwens, Leiderdorp, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Kaaijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG Oost, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Koks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'de Koning', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tergooi Hospital, Blaricum, The Netherlands.'}, {'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Klijn', 'Affiliation': 'Reproductive Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'P J Q', 'Initials': 'PJQ', 'LastName': 'van der Linden', 'Affiliation': 'Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Manger', 'Affiliation': 'Department of Obstetrics and Gynaecology, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'R H F', 'Initials': 'RHF', 'LastName': 'van Oppenraaij', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maasstad ziekenhuis, Rotterdam, The Netherlands.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Pieterse', 'Affiliation': 'Department of Obstetrics and Gynaecology, Haga ziekenhuis, Den Haag, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Smeenk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Visser', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amphia Ziekenhuis, Breda, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Human reproduction open,['10.1093/hropen/hoab035']
1574,35692966,Crosslinking vs. Observation in Fellow Eyes of Keratoconus Patients.,"Purpose


To evaluate whether unilateral crosslinking (CXL) and conservative follow-up of the fellow eye is an acceptable management strategy in patients with keratoconus (KC).
Methods


Seventy-nine fellow eyes of KC subjects that initially underwent unilateral CXL were included. Thirty fellow eyes ultimately received CXL (group 1) whereas 49 fellow eyes were followed (group 2). Best spectacle corrected visual acuity (BSCVA) and corneal tomographic parameters were collected in all eyes preoperatively and at the last follow-up.
Results


Subjects who received CXL in the fellow eye (group 1) were younger than subjects who did not (group 2,  p =0.026). Group 1 eyes had higher baseline K1 ( p =0.026), K2 ( p =0.006), Km ( p =0.01), and Kmax ( p =0.002) compared to group 2 eyes. Amongst the 49 naïve fellow eyes (group 2), 19 eyes showed evidence of progression. Progressing naïve eyes had higher baseline K1, K2, Km, and Kmax ( p  < 0.01); progressors also had thinner pachymetry at the pupil, apex, and thinnest point ( p  < 0.01). Baseline values of K1 ≥ 43.5 Diopter (D), K2 > 45.1D, Km > 44.3D, K max  > 47.9D, astigmatism > 1.4D, pachymetry at the pupil <475  μ m, and thinnest pachymetry <478  μ m were tentative predictors of progression in the naïve fellow eye.
Conclusions


Unilateral CXL with vigilant follow up of the fellow eye may be an acceptable management strategy in a subset of KC eyes.",2022,"Group 1 eyes had higher baseline K1 ( p =0.026), K2 ( p =0.006), Km ( p =0.01), and Kmax ( p =0.002) compared to group 2 eyes.","['Methods\n\n\nSeventy-nine fellow eyes of KC subjects that initially underwent unilateral CXL were included', 'patients with keratoconus (KC', 'Thirty fellow eyes ultimately received', 'Fellow Eyes of Keratoconus Patients']","['unilateral crosslinking (CXL) and conservative follow-up of the fellow eye', 'CXL']","['evidence of progression', 'baseline K1, K2, Km, and Kmax', 'Best spectacle corrected visual acuity (BSCVA) and corneal tomographic parameters']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0260933,"Group 1 eyes had higher baseline K1 ( p =0.026), K2 ( p =0.006), Km ( p =0.01), and Kmax ( p =0.002) compared to group 2 eyes.","[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Di Meglio', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jiangxia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Fasika A', 'Initials': 'FA', 'LastName': 'Woreta', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kraig S', 'Initials': 'KS', 'LastName': 'Bower', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Jhanji', 'Affiliation': 'UPMC Eye Center, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Srikumaran', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Uri S', 'Initials': 'US', 'LastName': 'Soiberman', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Journal of ophthalmology,['10.1155/2022/4661392']
1575,35692935,Role of Transcutaneous Electric Nerve Stimulation in Pain and Pulmonary Function in Patients after Bariatric Surgery.,"Background


Changes in lifestyle, a carbohydrate-rich diet, and decreased physical activity are part of the context that led to an obesity pandemic. Treating obesity is a task that requires multidisciplinary care; however, in many cases, conventional therapy has no effect, requiring surgical intervention. This, in turn, is not without risks and causes important changes in lung function. Therefore, the aim of this study is to evaluate the effect of electroanalgesia through conventional transcutaneous electrical nerve stimulation (TENS) on the pain and lung function in the postoperative period of bariatric surgery.
Methods


This is a controlled and blinded clinical trial with 66 subjects who underwent bariatric surgery. The participants were randomized into 2 groups as follows: an intervention group treated with TENS ( n  = 33) and a placebo group ( n  = 33). The participants underwent 4 TENS sessions, and the effect on pain was assessed using a visual analogue scale (VAS pain). Lung function was measured by spirometry.
Results


There were no differences between the 2 groups regarding time of surgery and time of mechanical ventilation. Compared to placebo, TENS reduced pain in the intervention group ( p  = 0.001). Regarding the effect of electroanalgesia on pulmonary function, the spirometric parameters were similar between the groups. However, regarding muscle strength between the preoperative and postoperative periods, maximal inspiratory pressure (MIP) was maintained in the intervention group and decreased in the placebo group ( p  = 0.03). Compared with that in the intervention group, the respiratory rate in the placebo group increased during the application of TENS ( p  = 0.003).
Conclusion


Electroanalgesia reduces pain in patients who underwent bariatric surgery. Importantly, in these patients, the MIP is maintained between the preoperative and postoperative periods. However, electroanalgesia does not contribute to improvements in spirometric data. This trial is registered with NCT04800640.",2022,"Compared to placebo, TENS reduced pain in the intervention group ( p  = 0.001).","['Patients after Bariatric Surgery', 'patients who underwent bariatric surgery', '66 subjects who underwent bariatric surgery']","['electroanalgesia', 'electroanalgesia through conventional transcutaneous electrical nerve stimulation (TENS', 'Transcutaneous Electric Nerve Stimulation', 'intervention group treated with TENS', 'Electroanalgesia', 'placebo']","['pain', 'maximal inspiratory pressure (MIP', 'respiratory rate', 'Lung function', 'Pain and Pulmonary Function', 'time of surgery and time of mechanical ventilation', 'pain and lung function', 'visual analogue scale (VAS pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C1522015', 'cui_str': 'Electroanalgesia'}, {'cui': 'C0394678', 'cui_str': 'Conventional transcutaneous electrical nerve stimulation'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",66.0,0.0346075,"Compared to placebo, TENS reduced pain in the intervention group ( p  = 0.001).","[{'ForeName': 'Cesar Antonio', 'Initials': 'CA', 'LastName': 'Luchesa', 'Affiliation': 'Rehabilitation Sciences Post-Graduation Programme, Augusto Motta University Center (UNISUAM), Rio de Janeiro, Brazil.'}, {'ForeName': 'Agnaldo José', 'Initials': 'AJ', 'LastName': 'Lopes', 'Affiliation': 'Rehabilitation Sciences Post-Graduation Programme, Augusto Motta University Center (UNISUAM), Rio de Janeiro, Brazil.'}]",Rehabilitation research and practice,['10.1155/2022/9138602']
1576,35692915,Cold snare polypectomy of colorectal polyps ≤ 10 mm on clopidogrel: Australian and New Zealand randomized controlled trial.,,2022,,[],"['Cold snare polypectomy', 'clopidogrel']",[],[],"[{'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]",[],,0.310172,,"[{'ForeName': 'Shara', 'Initials': 'S', 'LastName': 'Ket', 'Affiliation': 'Department of Gastroenterology, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Hewett', 'Affiliation': 'Department of Gastroenterology, Queen Elizabeth II Jubilee Hospital, Queensland.'}, {'ForeName': 'Ammar O', 'Initials': 'AO', 'LastName': 'Kheir', 'Affiliation': 'Department of Gastroenterology, Queen Elizabeth II Jubilee Hospital, Queensland.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Metz', 'Affiliation': 'Department of Gastroenterology, Melbourne Health, Victoria, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Moss', 'Affiliation': 'Department of Endoscopic Services, Western Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Ogra', 'Affiliation': 'Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Tjandra', 'Affiliation': 'Department of Gastroenterology, Melbourne Health, Victoria, Australia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tam', 'Affiliation': 'Royal Adelaide Hospital, South Australia, Australia.'}, {'ForeName': 'Spiro', 'Initials': 'S', 'LastName': 'Raftopoulos', 'Affiliation': 'Sir Charles Gairdner Hospital, Western Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Biostatistics Consulting Platform, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Secomb', 'Affiliation': 'Department of Gastroenterology, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Cavalieri', 'Affiliation': 'Eastern Health, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Urquhart', 'Affiliation': 'Eastern Health, Victoria, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Gibson', 'Affiliation': 'Department of Gastroenterology, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': 'Department of Gastroenterology, Alfred Health, Melbourne, Victoria, Australia.'}]",Endoscopy international open,['10.1055/a-1813-1019']
1577,35692895,"Feasibility of an Integrated Treatment Approach for Youth with Depression, Suicide Attempts, and Substance Use Problems.","Depression, suicidal behaviors and substance use problems frequently co-occur, and treatment for youth with these co-occurring problems is often fragmented and challenging. An integrated cognitive-behavioral treatment approach that builds upon a relapse prevention framework and applies common core skills, language, and approach for treating these related problems may be clinically beneficial. Following a description of the integrated approach, we present results of a pilot trial (n = 13) to examine the acceptability and feasibility of the Cognitive-Behavioral Therapy - Relapse Prevention (CBT-RP) intervention plus enhanced treatment as usual (TAU) compared to enhanced TAU alone. The feasibility of the CBT-RP + TAU intervention was reflected by high rates of retention (86%). The acceptability was reflected in positive evaluations regarding the helpfulness of the intervention by adolescents and families. The majority of youth in both CBT-RP + TAU and TAU alone groups evidenced reductions in depression and suicide ideation from study entry to Week 20. Patterns of reduction were more consistent, however, for youth receiving CBT-RP + TAU, and reductions were slower to emerge for some youth receiving TAU alone. Reductions in alcohol and marijuana problems were similar, but half of the youth in TAU alone (and none in the CBT-RP + TAU group) had emergency department visits related to psychiatric crises or substance related problems. These findings, although based on a small sample, underscore the feasibility and acceptability of an integrated cognitive-behavioral relapse prevention approach for youth with depression, suicide attempt histories, and substance use problems.",2021,The majority of youth in both CBT-RP + TAU and TAU alone groups evidenced reductions in depression and suicide ideation from study entry to Week 20.,"['Youth with Depression, Suicide Attempts, and Substance Use Problems']","['Cognitive-Behavioral Therapy - Relapse Prevention (CBT-RP) intervention plus enhanced treatment as usual (TAU', 'CBT-RP + TAU intervention']",['depression and suicide ideation'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}]",,0.0217394,The majority of youth in both CBT-RP + TAU and TAU alone groups evidenced reductions in depression and suicide ideation from study entry to Week 20.,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Goldston', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Curry', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Wells', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yifrah', 'Initials': 'Y', 'LastName': 'Kaminer', 'Affiliation': 'Department of Psychiatry, University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Daniel', 'Affiliation': 'Department of Family and Community Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Christianne', 'Initials': 'C', 'LastName': 'Esposito-Smythers', 'Affiliation': 'Department of Psychology, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Otima', 'Initials': 'O', 'LastName': 'Doyle', 'Affiliation': 'Jane Addams School of Social Work, University of Illinois Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sapyta', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Tunno', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': 'Heilbron', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Roley-Roberts', 'Affiliation': 'Department of Psychiatry, Creighton University School of Medicine, Omaha, NE, USA.'}]",Evidence-based practice in child and adolescent mental health,['10.1080/23794925.2021.1888664']
1578,35692885,"Effects of Metformin on Renal Function, Cardiac Function, and Inflammatory Response in Diabetic Nephropathy and Its Protective Mechanism.","Objective


To investigate the effect of metformin on renal function, cardiac function, and inflammatory response in diabetic nephropathy and its protective mechanism.
Methods


A total of 88 patients with diabetic nephropathy who were admitted to our hospital from April 2019 to October 2020 were recruited and grouped according to different treatment methods, namely, the experimental group ( n  = 44) and the control group ( n  = 44). The patients in the experimental group were treated with metformin, and the patients in the control group were treated with liraglutide injection (nonmetformin). Left ventricular end-diastolic diameter (LVEDD), left ventricular ejection fraction (LVEF), left ventricular end-systolic diameter (LVESD), and inflammatory response (hs-CRP, TNF- α , IL-6) were compared.
Results


Compared with corresponding values before treatment, BUN, Scr, hs-CRP, TNF- α , IL-6, LVEDD, and LVESD were decreased after treatment, whereas LVEF was increased (all  P  < 0.05), with significant change in the experimental group (all  P  < 0.001).
Conclusion


Metformin can effectively improve the level of renal function and cardiac function in patients with diabetic nephropathy and help patients control and reduce the body's inflammatory response, and its therapeutic efficacy is superior to that of liraglutide injection.",2022,"Compared with corresponding values before treatment, BUN, Scr, hs-CRP, TNF- α , IL-6, LVEDD, and LVESD were decreased after treatment, whereas LVEF was increased (all  P  < 0.05), with significant change in the experimental group (all  P  < 0.001).
","['88 patients with diabetic nephropathy who were admitted to our hospital from April 2019 to October 2020', 'patients with diabetic nephropathy']","['Metformin', 'liraglutide injection (nonmetformin', 'metformin']","['LVEF', 'BUN, Scr, hs-CRP, TNF- α , IL-6, LVEDD, and LVESD', 'Left ventricular end-diastolic diameter (LVEDD), left ventricular ejection fraction (LVEF), left ventricular end-systolic diameter (LVESD), and inflammatory response (hs-CRP, TNF- α , IL-6', 'renal function, cardiac function, and inflammatory response', 'level of renal function and cardiac function', 'Renal Function, Cardiac Function, and Inflammatory Response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",88.0,0.0160935,"Compared with corresponding values before treatment, BUN, Scr, hs-CRP, TNF- α , IL-6, LVEDD, and LVESD were decreased after treatment, whereas LVEF was increased (all  P  < 0.05), with significant change in the experimental group (all  P  < 0.001).
","[{'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'Department of Rheumatology and Immunology, Shijingshan Teaching Hospital of Capital Medical University, Beijing Shijingshan Hospital, Beijing 100043, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': 'Department of Nephrology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, China-Japan Union Hospital of Jilin University, Changchun, China.'}]",Disease markers,['10.1155/2022/8326767']
1579,35692883,Combination of Calcitriol and Zoledronic Acid on PINP and  β -CTX in Postoperative Patients with Diabetic Osteoporosis: A Randomized Controlled Trial.,"Objective


To explore the effect of calcitriol combined with zoledronic acid in posterior cruciate ligament tibial avulsion fractures of the knee joint in patients with diabetic osteoporosis.
Methods


Between January 2020 and January 2022, 60 patients with diabetic osteoporosis treated in our hospital were included. All patients underwent knee joint posterior cruciate ligament tibial avulsion fractures, and they were randomized (1 : 1) into the observation group (calcitriol combined with zoledronic acid) and control group (calcitriol). The two groups were compared with respect to the improvement of bone mineral density and bone metabolism indexes, the pain degree (VAS) and knee joint function (Lysholm), and the incidence of refracture.
Results


Both groups showed an increasing bone mineral density after treatment, and significant increase was observed in the observation group vs. control group (all  p  < 0.05). After treatment, VAS scores decreased in the two groups, and Lysholm scores increased compared to the corresponding values before treatment (all  p  < 0.05), with more notable changes in the observation group versus control group (all  p  < 0.05). The observation group had fewer cases of refractures than the control group (2 cases vs. 8 cases) ( p  < 0.05).
Conclusion


Calcitriol combined with zoledronic acid used in patients with diabetic osteoporosis after the posterior cruciate ligament tibial attachment avulsion fracture of the knee joint yields a promising result in enhancing bone mineral density and bone metabolism indicators, relieving pain, improving knee joint function, and reducing the risk of refracture.",2022,"After treatment, VAS scores decreased in the two groups, and Lysholm scores increased compared to the corresponding values before treatment (all  p  < 0.05), with more notable changes in the observation group versus control group (all  p  < 0.05).","['patients with diabetic osteoporosis after the posterior cruciate ligament tibial attachment avulsion fracture', 'patients with diabetic osteoporosis', 'Methods\n\n\nBetween January 2020 and January 2022, 60 patients with diabetic osteoporosis treated in our hospital were included', 'posterior cruciate ligament tibial avulsion fractures', 'All patients underwent knee joint posterior cruciate ligament tibial avulsion fractures', 'Postoperative Patients with Diabetic Osteoporosis']","['calcitriol combined with zoledronic acid', 'Calcitriol combined with zoledronic acid', 'observation group (calcitriol combined with zoledronic acid) and control group (calcitriol', 'Calcitriol and Zoledronic Acid']","['bone mineral density and bone metabolism indexes, the pain degree (VAS) and knee joint function (Lysholm), and the incidence of refracture', 'Lysholm scores', 'bone mineral density and bone metabolism indicators, relieving pain, improving knee joint function', 'VAS scores', 'bone mineral density']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0080039', 'cui_str': 'Structure of posterior cruciate ligament of knee joint'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0332758', 'cui_str': 'Avulsion fracture'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",60.0,0.0179224,"After treatment, VAS scores decreased in the two groups, and Lysholm scores increased compared to the corresponding values before treatment (all  p  < 0.05), with more notable changes in the observation group versus control group (all  p  < 0.05).","[{'ForeName': 'Qingchang', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Emergency Medicine, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""People's Hospital of Qingxian, Qingxian, China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Anesthesia Operating Room, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Lishuai', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': ""People's Hospital of Qingxian, Qingxian, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""People's Hospital of Qingxian, Qingxian, China.""}, {'ForeName': 'Guangdong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedics, Cangzhou Central Hospital, Cangzhou, China.'}]",Disease markers,['10.1155/2022/6053410']
1580,35693356,Programmed-release intraosseus anesthesia as an alternative to lower alveolar nerve block in lower third molar extraction: a randomized clinical trial.,"Background


Intraosseous anesthesia is the process by which an anesthetic solution, after penetration of the cortical bone, is directly injected into the spongiosa of the alveolar bone supporting the tooth. This study aimed to compare the effectiveness of the traditional inferior alveolar nerve block (IANB) and computerized intraosseous anesthesia in the surgical extraction of impacted lower third molars, compare their side effects systemically by monitoring heart rate, and assess patients' a posteriori preference of one technique over the other.
Methods


Thirty-nine patients with bilaterally impacted third molars participated in this study. Each patient in the sample was both a case and control, where the conventional technique was randomly assigned to one side (group 1) and the alternative method to the contralateral side (group 2).
Results


The traditional technique was faster in execution than anesthesia delivered via electronic syringe, which took 3 min to be administered. However, it was necessary to wait for an average of 6 ± 4 min from the execution to achieve the onset of IANB, while the latency of intraosseous anesthesia was zero. Vincent's sign and lingual nerve anesthesia occurred in 100% of cases in group 1. In group 2, Vincent's sign was recorded in 13% of cases and lingual anesthesia in four cases. The average duration of the perceived anesthetic effect was 192 ± 68 min in group 1 and 127 ± 75 min in group 2 (P < 0.001). The difference between the heart rate of group 1 and group 2 was statistically significant. During infiltration in group 1, heartbeat frequency increased by 5 ± 13 beats per minute, while in group 2, it increased by 22 ± 10 beats per minute (P < 0.001). No postoperative complications were reported for either technique. Patients showed a preference of 67% for the alternative technique and 20% for the traditional, and 13% of patients were indifferent.
Conclusion


The results identified intraosseous anesthesia as a valid alternative to conventional anesthesia in impacted lower third molar extraction.",2022,No postoperative complications were reported for either technique.,['Methods\n\n\nThirty-nine patients with bilaterally impacted third molars participated in this study'],"['traditional inferior alveolar nerve block (IANB) and computerized intraosseous anesthesia', 'Programmed-release intraosseus anesthesia']","[""Vincent's sign and lingual nerve anesthesia"", 'postoperative complications', 'average duration of the perceived anesthetic effect', 'heartbeat frequency', 'heart rate']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C4285980', 'cui_str': 'Intraosseous anaesthesia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0023740', 'cui_str': 'Structure of lingual nerve'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3179301', 'cui_str': 'Anesthetic Effects'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",39.0,0.0376395,No postoperative complications were reported for either technique.,"[{'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Pol', 'Affiliation': 'Oral Surgery Unit, Dentistry Section, Department of Surgical Sciences, University of Turin, Dental School, Turin, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Ruggiero', 'Affiliation': 'Oral Surgery Unit, Dentistry Section, Department of Surgical Sciences, University of Turin, Dental School, Turin, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bezzi', 'Affiliation': 'Oral Surgery Unit, Dentistry Section, Department of Surgical Sciences, University of Turin, Dental School, Turin, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Camisassa', 'Affiliation': 'Oral Surgery Unit, Dentistry Section, Department of Surgical Sciences, University of Turin, Dental School, Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Carossa', 'Affiliation': 'Oral Surgery Unit, Dentistry Section, Department of Surgical Sciences, University of Turin, Dental School, Turin, Italy.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2022.22.3.217']
1581,35693350,"Evaluating anxiety levels and pain perception while administering local anesthesia using conventional, insulin, and deception syringes in 6-12-year-olds.","Background


Injections are one of the most fear-provoking stimuli in dentistry. Painless administration of an injection is a vital step in alleviating anxiety, which in turn leads to good behavior in children. The aim is to evaluate and compare anxiety levels and pain perception using conventional, insulin, and deception syringes during the administration of local anesthesia in children.
Methods


Forty-five children aged 6-12 were selected using a standard sample size formula and equally divided into three groups. Local anesthesia was administered using a conventional syringe to Group A participants and an insulin syringe for Group B participants. Group C participants were administered local anesthesia using a deception syringe by showing the patient disposable obturation tips, and eventually a conventional syringe was used for administration of local anesthesia after hiding them from the patient. Anxiety levels were assessed using Venham's Picture Scale and pulse rate at baseline and after administration of local anesthesia. The Wong-Baker Faces Pain Rating Scale was used to assess pain perception after the administration of local anesthesia.
Results


Insulin and deception syringes showed better reduction in anxiety levels and pain perception than conventional syringes, demonstrating a high statistically significant difference.
Conclusion


The use of insulin and deception syringes for administration of anesthesia was demonstrated to be effective in alleviating anxiety in children and is therefore recommended as an alternative to conventional syringes.",2022,"Results


Insulin and deception syringes showed better reduction in anxiety levels and pain perception than conventional syringes, demonstrating a high statistically significant difference.
","['Methods\n\n\nForty-five children aged 6-12 were selected using a standard sample size formula and equally divided into three groups', 'children', '6-12-year-olds']","['conventional, insulin, and deception syringes', 'local anesthesia using conventional, insulin, and deception syringes', 'local anesthesia using a deception syringe', 'conventional syringe to Group A participants and an insulin syringe', 'insulin and deception syringes', 'Local anesthesia']","['pain perception', 'Wong-Baker Faces Pain Rating Scale', 'anxiety levels and pain perception', 'Anxiety levels', 'Evaluating anxiety levels and pain perception']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0024195', 'cui_str': 'Deception'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",45.0,0.0479835,"Results


Insulin and deception syringes showed better reduction in anxiety levels and pain perception than conventional syringes, demonstrating a high statistically significant difference.
","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Kohli', 'Affiliation': ""Department of Pediatric and Preventive Dentistry, KAHER'S KLE VK Institute of Dental Sciences, Belagavi, Karnataka, India.""}, {'ForeName': 'Shivayogi M', 'Initials': 'SM', 'LastName': 'Hugar', 'Affiliation': ""Department of Pediatric and Preventive Dentistry, KAHER'S KLE VK Institute of Dental Sciences, Belagavi, Karnataka, India.""}, {'ForeName': 'Vidyavathi H', 'Initials': 'VH', 'LastName': 'Patil', 'Affiliation': ""Department of Pediatric and Preventive Dentistry, KAHER'S KLE VK Institute of Dental Sciences, Belagavi, Karnataka, India.""}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Saxena', 'Affiliation': ""Department of Pediatric and Preventive Dentistry, KAHER'S KLE VK Institute of Dental Sciences, Belagavi, Karnataka, India.""}, {'ForeName': 'Krishna S', 'Initials': 'KS', 'LastName': 'Kadam', 'Affiliation': ""Department of Pediatric and Preventive Dentistry, KAHER'S KLE VK Institute of Dental Sciences, Belagavi, Karnataka, India.""}, {'ForeName': 'Sanika', 'Initials': 'S', 'LastName': 'Karmarkar', 'Affiliation': ""Department of Pediatric and Preventive Dentistry, KAHER'S KLE VK Institute of Dental Sciences, Belagavi, Karnataka, India.""}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2022.22.3.197']
1582,35693308,Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract (Kamikawa Versus Double-Tract Reconstruction Versus Tube-Like Stomach) After Proximal Gastrectomy.,"Background


Appropriate gastrointestinal reconstruction after proximal gastrectomy can effectively reduce the incidence of postoperative complications in patients with proximal early gastric cancer. However, there is still great controversy about the choice of digestive tract reconstruction after proximal gastrectomy, and there is no clinical consensus on the choice of digestive tract reconstruction after proximal gastrectomy. Currently, there is a lack of large-sample, prospective, randomized controlled studies to compare the efficacy of Kamikawa, double-tract reconstruction, and tube-like stomach reconstruction after proximal gastrectomy.
Methods/design


This study will investigate the efficacy of three reconstruction methods after proximal gastrectomy in a prospective, multicenter, randomized controlled trial, which will enroll 180 patients with proximal early gastric cancer. Patients will be randomly divided into three groups: Group A (Kamikawa,  n  = 60), Group B (double-tract reconstruction,  n  = 60), and Group C (tube-like stomach,  n  = 60). The general information, past medical history, laboratory findings, imaging findings, and surgical procedures of the patients will be recorded and analyzed. The incidence of reflux esophagitis will be recorded as the primary endpoint. The incidence of anastomotic leakage, anastomotic stenosis, operative time and intraoperative blood loss will be recorded as secondary endpoints.
Discussion


This study will establish a large-sample, prospective, randomized controlled trial to compare the efficacy of Kamikawa, double-tract reconstruction, and tube-like stomach reconstruction after proximal gastrectomy.
Trial registration


This study was approved by the Chinese Clinical Trial Registry and registered on April 30, 2021. The registration number is ChiCTR2100045975.",2022,"The incidence of anastomotic leakage, anastomotic stenosis, operative time and intraoperative blood loss will be recorded as secondary endpoints.
","['180 patients with proximal early gastric cancer', 'Chinese Clinical Trial Registry and registered on April 30, 2021', 'patients with proximal early gastric cancer']","['Kamikawa, double-tract reconstruction, and tube-like stomach reconstruction after proximal gastrectomy', 'Versus Tube-Like Stomach', 'Digestive Tract (Kamikawa Versus Double-Tract Reconstruction', 'proximal gastrectomy', 'Proximal Gastrectomy']","['postoperative complications', 'incidence of anastomotic leakage, anastomotic stenosis, operative time and intraoperative blood loss', 'reflux esophagitis']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0349530', 'cui_str': 'Early gastric cancer'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0842140', 'cui_str': 'Stomach reconstruction'}, {'cui': 'C0399713', 'cui_str': 'Proximal subtotal gastrectomy'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0014869', 'cui_str': 'Esophagitis, Reflux'}]",180.0,0.110516,"The incidence of anastomotic leakage, anastomotic stenosis, operative time and intraoperative blood loss will be recorded as secondary endpoints.
","[{'ForeName': 'Wei Dong', 'Initials': 'WD', 'LastName': 'Wang', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Rui Qi', 'Initials': 'RQ', 'LastName': 'Gao', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Dan Hong', 'Initials': 'DH', 'LastName': 'Dong', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Qin Chuan', 'Initials': 'QC', 'LastName': 'Yang', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Hai Kun', 'Initials': 'HK', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Jiang Peng', 'Initials': 'JP', 'LastName': 'Wei', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Peng Fei', 'Initials': 'PF', 'LastName': 'Yu', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Xi Sheng', 'Initials': 'XS', 'LastName': 'Yang', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiao Hua', 'Initials': 'XH', 'LastName': 'Li', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': ""Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.""}]",Frontiers in surgery,['10.3389/fsurg.2022.891693']
1583,35686579,Somatosensory Profiles Differentiate Pain and Psychophysiological Symptoms Among Young Adults With Irritable Bowel Syndrome: A Cluster Analysis.,"OBJECTIVE


The aim of this study was to investigate if somatosensory profiles can differentiate pain and psychophysiological symptoms among young adults with irritable bowel syndrome (IBS).
METHODS


We performed a cluster analysis of data collected from a randomized clinical trial of 80 IBS patients and 21 age-matched healthy controls (HCs) to stratify pain and symptoms among young adults with IBS by their peripheral sensory profiles. Data of quantitative sensory testing and IBS-related pain and symptoms were collected at baseline and 6-week and 12-week follow-ups.
RESULTS


Using the K-means method, IBS patients were classified into 2 clusters, the ""IBS normal threshold"" (IBS-NT) and the ""IBS increased threshold"" (IBS-IT). The IBS-NT cluster had a similar pain threshold as the HCs, and the IBS-IT cluster had an increased threshold of somatic pain perception (lower cold pain threshold, higher heat pain threshold, and higher pressure pain threshold, all P<0.001) than HCs. Compared with the IBS-NT cluster, the IBS-IT cluster reported higher levels of IBS-related pain intensity, anxiety, fatigue, and sleep disturbance over the 3 visits (all P<0.05).
DISCUSSION


Young adults with IBS fell into 2 clusters, one with a similar sensory threshold as the HCs and another with an increased pain threshold, who reported higher pain intensity and more severe symptoms. Somatic sensory profiles should be integrated into further personalized self-management intervention among patients with IBS.",2022,"Compared with the IBS-NT cluster, the IBS-IT cluster reported higher levels of IBS-related pain intensity, anxiety, fatigue, and sleep disturbance over the 3 visits (all P<0.05).
","['young adults with irritable bowel syndrome (IBS', 'patients with IBS', 'Young Adults With Irritable Bowel Syndrome', '80 IBS patients and 21 age-matched healthy controls (HCs) to stratify pain and symptoms among young adults with IBS by their peripheral sensory profiles']",[],"['pain intensity', 'levels of IBS-related pain intensity, anxiety, fatigue, and sleep disturbance', 'somatic pain perception']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2732625', 'cui_str': 'Sensory profile'}]",[],"[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0234244', 'cui_str': 'Somatic pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",80.0,0.0501331,"Compared with the IBS-NT cluster, the IBS-IT cluster reported higher levels of IBS-related pain intensity, anxiety, fatigue, and sleep disturbance over the 3 visits (all P<0.05).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Zahra A', 'Initials': 'ZA', 'LastName': 'Barandouzi', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Wanli', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Department of Biomedical Engineering, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Ki', 'Initials': 'K', 'LastName': 'Chon', 'Affiliation': 'Department of Biomedical Engineering, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': ""Pediatric Obesity Center, Connecticut Children's Medical Center, Harford, CT.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Starkweather', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Cong', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, CT.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000001046']
1584,35686576,Rapid Transition to Virtual Assessment and Treatment in an Interdisciplinary Randomized Clinical Trial for Youth With Chronic Pain: Adaptations and Implications for Future Trials.,"OBJECTIVES


COVID-19 abruptly halted in-person clinical care and research requiring a shift to virtual assessment and treatment. This unexpected transition of a 2-arm randomized controlled trial (RCT) examining interdisciplinary graded exposure treatment (GET Living) compared with multidisciplinary pain management for youth with chronic pain provided an opportunity to implement the first remotely delivered exposure treatment and remotely delivered biomechanical assessment for pediatric chronic pain. Here we describe these new approaches and provide lessons learned to inform future efforts in digital health care.
METHODS


A total of 68 youth (M=14.2 y; 80.9% female) were enrolled in the RCT (n=31 in-person, n=5 hybrid, n=32 virtual, n=9 withdrew). Of those withdrawn, n=3 withdrew due to COVID-19 related reasons. Some RCT elements required slight modification (eg, e-consent, actigraphy deployment, recruitment, and screening), while others were significantly altered (eg, session format and lab-based biomechanical assessment). Data from exit interviews were also examined to assess perspectives on the virtual format transition.
RESULTS


Results showed an increased enrollment rate when virtual care was an option (70.7%) compared with in-person (44.3%). Equivalent rates of completion for daily assessment (in-person, 72.8%; virtual, 73.3) were also observed, and participants described enhanced experience when able to complete exercises and exposures in their home environment during session (vs. a rehabilitation gym) allowing for genuine in vivo exposures (eg, household chores, riding bicycles).
DISCUSSION


Overall, our data demonstrate acceptability, feasibility, and equivalent patient engagement to virtual treatment. Novel methods implemented in this RCT can inform trial design and measures of clinical endpoints for future digital health interventions.",2022,"Equivalent rates of completion for daily assessment (in-person, 72.8%; virtual, 73.3) were also observed, and participants described enhanced experience when able to complete exercises and exposures in their home environment during session (vs. a rehabilitation gym) allowing for genuine in vivo exposures (eg, household chores, riding bicycles).
","['youth with chronic pain', 'A total of 68 youth (M=14.2\u2009y; 80.9% female) were enrolled in the RCT (n=31 in-person, n=5 hybrid, n=32 virtual, n=9 withdrew', 'Youth With Chronic Pain', 'pediatric chronic pain']","['interdisciplinary graded exposure treatment (GET Living', 'multidisciplinary pain management']",['enrollment rate'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0036369', 'cui_str': 'School Enrollment'}]",68.0,0.259127,"Equivalent rates of completion for daily assessment (in-person, 72.8%; virtual, 73.3) were also observed, and participants described enhanced experience when able to complete exercises and exposures in their home environment during session (vs. a rehabilitation gym) allowing for genuine in vivo exposures (eg, household chores, riding bicycles).
","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Shear', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Harrison', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto.'}, {'ForeName': 'Zeena', 'Initials': 'Z', 'LastName': 'Khazendar', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Lyons', 'Affiliation': ""Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Sunnyvale, CA.""}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Morgan', 'Affiliation': ""Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Sunnyvale, CA.""}, {'ForeName': 'Salinda K', 'Initials': 'SK', 'LastName': 'Chan', 'Affiliation': ""Motion and Sports Performance Lab, Department of Orthopedic Sports Medicine, Lucile Packard Children's Hospital, Sunnyvale, CA.""}, {'ForeName': 'Amanda B', 'Initials': 'AB', 'LastName': 'Feinstein', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Simons', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000001040']
1585,35686399,Starting Antrectomy in Less than 2 cm from Pylorus at Laparoscopic Sleeve Gastrectomy.,"OBJECTIVE


To evaluate the effect of antrectomy in which resection was started from 2 cm or closer to the pylorus on % excess weight loss (EWL), nausea, vomiting, and complication rates.
STUDY DESIGN


Comparative study.
PLACE AND DURATION OF STUDY


Antalya Training and Research Hospital, from April 2018 to December 2018.
METHODOLOGY


Patients in whom laparoscopic sleeve gastrectomy (LSG)were done starting at a level of 2 cm or closer to pylorus were included in the study. Patients were divided into one of the two groups based on the distance between the pylorus and the resection margin: group 1 having resection ≤10 mm and group 2 at 11-20 mm. Above mentioned parameters were compared in both groups.
RESULTS


Ninety-two patients were included. Postoperative nausea and vomiting rates were similar in both groups. At the end of the first year, % EWL was 82.9% and 73.5% in groups 1 and 2 (p=0.003).
CONCLUSION


Starting antrectomy at a distance of 2 cm or less from the pylorus is safe and effective. Starting antrectomy at a distance of 1 cm or less from the pylorus in LSG provides effective weight loss without increasing complications.
KEY WORDS


Bariatric surgery, Antrectomy, Laparoscopic sleeve gastrectomy, Complications.",2022,Postoperative nausea and vomiting rates were similar in both groups.,"['Ninety-two patients were included', 'Patients in whom laparoscopic sleeve gastrectomy (LSG)were done starting at a level of 2 cm or closer to pylorus were included in the study']","['Laparoscopic Sleeve Gastrectomy', 'Laparoscopic sleeve gastrectomy, Complications']","['weight loss (EWL), nausea, vomiting, and complication rates', 'Postoperative nausea and vomiting rates']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",92.0,0.0311757,Postoperative nausea and vomiting rates were similar in both groups.,"[{'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Mayir', 'Affiliation': 'Department of General Surgery, Antalya Training and Research Hospital, Antalya, Turkey.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2022.06.701']
1586,35686709,Comparative Contralateral Randomized Clinical Trial of Standard (3 mW/cm 2 ) Versus Accelerated (9 mW/cm 2 ) CXL in Patients With Down Syndrome: 3-Year Results.,"PURPOSE


To compare the long-term results of accelerated corneal cross-linking (CXL) (9 mW/cm 2 , 10 min) with standard CXL (3 mW/cm 2 , 30 min) in patients with Down syndrome who had keratoconus.
METHODS


In this contralateral randomized clinical trial, 27 patients with Down syndrome aged 15.78 ± 2.46 years (range: 10 to 19 years) were enrolled. CXL was performed using the KXL System (Avedro, Inc) under general anesthesia, and patients were followed up for 3 years. The main outcome measure was a change in average keratometry in the 3-mm zone around the steepest point (zonal Kmax-3mm). Secondary outcomes were changes in Corvis ST (Oculus Optikgeräte GmbH) biomechanical parameters and vision, refraction, and corneal tomography measurements.
RESULTS


Mean 3-year changes in zonal Kmax-3mm were not significantly different between the accelerated and standard groups (-0.06 ± 0.75 and -0.35 ± 0.94 diopters [D], respectively,  P  = .727). Despite the contralateral design of the study, based on most baseline biomechanical indices, corneas in the standard group were weaker before treatment. The standard group also showed significantly fewer 3-year changes in the stress-strain index (-0.11 ± 0.21 vs -0.30 ± 0.32), integrated radius (+0.99 ± 3.48 vs +3.14 ± 2.84), and deformation amplitude ratio-2mm (-1.38 ± 1.33 vs +0.30 ± 1.75) (all  P  < .0167). Corneal stiffness in the accelerated group was stable for 2 years, and the decline mainly occurred during the third year.
CONCLUSIONS


In young patients with Down syndrome who had keratoconus, accelerated and standard CXL showed a similar flattening effect. Standard CXL is better able to maintain corneal stiffness in weaker corneas. With accelerated CXL, despite stable results for 2 years, there was decreased corneal stiffness in the third year. Longer follow-up periods are warranted to study the decreased efficacy on keratoconus progression.  [ J Refract Surg . 2022;38(6):381-388.] .",2022,"Mean 3-year changes in zonal Kmax-3mm were not significantly different between the accelerated and standard groups (-0.06 ± 0.75 and -0.35 ± 0.94 diopters [D], respectively,  P  = .727).","['Patients With Down Syndrome', 'patients with Down syndrome who had keratoconus', '27 patients with Down syndrome aged 15.78 ± 2.46 years (range: 10 to 19 years) were enrolled']","['accelerated corneal cross-linking (CXL) (9 mW/cm 2 , 10 min) with standard CXL', 'CXL']","['Mean 3-year changes in zonal Kmax-3mm', 'stress-strain index', 'Corneal stiffness', 'change in average keratometry in the 3-mm zone around the steepest point (zonal Kmax-3mm', 'deformation amplitude ratio-2mm', 'corneal stiffness', 'changes in Corvis ST (Oculus Optikgeräte GmbH) biomechanical parameters and vision, refraction, and corneal tomography measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C4728129', 'cui_str': 'Corneal cross linking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1564799', 'cui_str': 'Zonal'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",27.0,0.071447,"Mean 3-year changes in zonal Kmax-3mm were not significantly different between the accelerated and standard groups (-0.06 ± 0.75 and -0.35 ± 0.94 diopters [D], respectively,  P  = .727).","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Hashemi', 'Affiliation': ''}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Ambrósio', 'Affiliation': ''}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Mehravaran', 'Affiliation': ''}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hafezi', 'Affiliation': ''}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vinciguerra', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Vinciguerra', 'Affiliation': ''}, {'ForeName': 'Parsa', 'Initials': 'P', 'LastName': 'Panahi', 'Affiliation': ''}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Asgari', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20220329-01']
1587,35686900,"Comparison of the effects of ivermectin, permethrin, and gamma benzene hexachloride alone and with that of combination therapy for the management of scabies.","RESULTS


The present study compared three scabicidal agents alone or with combination, the currently considered medicine of choice permethrin, oral ivermectin, and gamma benzene hexachloride in the local population of India. A total of 120 patients were studied. They were randomly divided into four groups -Group A, Group B, Group C, and Group D. Group A received topical 5% permethrin and oral placebo. Group B was given topical placebo cream and oral ivermectin in two dose regimen. Group C received topical 1% gamma benzene hexachloride with oral placebo, and Group D was given topical 5% permethrin and oral ivermectin. The improvement of lesions and pruritus were assessed in the next three follow-ups, i.e., on the 7th day, 14th day, and 28th day along with any adverse drug reactions (ADRs). It was found that Group A had 83%, 90%, 97%, and Group B had 70%, 81%, and 91% improvement of lesions in the three follow-ups respectively. Group C showed 57%, 70%, 86%, and Group D had 82%, 90%, 97% efficiency to decrease lesion count (p>0.05) respectively. Again, Group A observed 77%, 88%, and 94% improvement in pruritus in subsequent follow-ups, while for Group B it was 63%, 76%, and 86%. Group C had 55%, 71%, 85% efficiency, and Group D had recorded 77%, 88%, and 94% improvement to decrease pruritus (p>0.05). The incidence of adverse effects was found to be less in Group B, Group C, and Group D when compared to Group A.
CONCLUSION


Group D or a combination therapy was a better choice for scabies in comparison to other monotherapy due to its better efficacy and safety profile.",2022,"The incidence of adverse effects was found to be less in Group B, Group C, and Group D when compared to Group A.
CONCLUSION


Group D or a combination therapy was a better choice for scabies in comparison to other monotherapy due to its better efficacy and safety profile.",['120 patients were studied'],"['topical placebo cream and oral ivermectin', 'topical 5% permethrin and oral placebo', 'topical 1% gamma benzene hexachloride with oral placebo', 'topical 5% permethrin and oral ivermectin', 'ivermectin, permethrin, and gamma benzene hexachloride alone and with that of combination therapy']","['lesion count', 'pruritus', 'adverse effects', 'lesions and pruritus', 'efficacy and safety profile']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0005038', 'cui_str': 'Lindane'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.0257413,"The incidence of adverse effects was found to be less in Group B, Group C, and Group D when compared to Group A.
CONCLUSION


Group D or a combination therapy was a better choice for scabies in comparison to other monotherapy due to its better efficacy and safety profile.","[{'ForeName': 'Saborni', 'Initials': 'S', 'LastName': 'Dey', 'Affiliation': 'Associate Professor, Pharmacology Department, Saraswathi Institute of Medical Sciences, Hapur, Uttar Pradesh, India; sabornidey7@gmail.com.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Professor and Head, Department of Dermatology, Venereology and Leprology, Saraswathi Institute of Medical Sciences, Hapur, Uttar Pradesh, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Sagar', 'Affiliation': 'Senior Resident, Department of Dermatology, Venereology and Leprology, Saraswathi Institute of Medical Sciences, Hapur, Uttar Pradesh, India.'}]",Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique,['10.47750/jptcp.2022.845']
1588,35687409,"A Theory-Informed, Personalized mHealth Intervention for Adolescents (Mobile App for Physical Activity): Development and Pilot Study.","BACKGROUND


Evidence suggests that physical activity (PA) during childhood and adolescence is crucial as it usually results in adequate PA levels in adulthood. Given the ubiquitous use of smartphones by adolescents, these devices may offer feasible means to reach young populations and deliver interventions aiming to increase PA participation and decrease sedentary time. To date, very few studies have reported smartphone-based interventions promoting PA for adolescents. In addition, most available fitness apps do not include the latest evidence-based content.
OBJECTIVE


This paper described the systematic development of a behavior change, theory-informed Mobile App for Physical Activity intervention with personalized prompts for adolescents aged 16 to 18 years. The within-subject trial results provided the first evidence of the general effectiveness of the intervention based on the outcomes step count, sedentary time, and moderate to vigorous PA (MVPA) minutes. The effectiveness of the intervention component personalized PA prompt was also assessed.
METHODS


A 4-week within-subject trial with 18 healthy adolescents aged 16 to 18 years was conducted (mean age 16.33, SD 0.57 years). After the baseline week, the participants used the Mobile App for Physical Activity intervention (Fitbit fitness tracker+app), which included a daily personalized PA prompt delivered via a pop-up notification. A paired 1-tailed t test was performed to assess the effectiveness of the intervention. Change-point analysis was performed to assess the effectiveness of a personalized PA prompt 30 and 60 minutes after prompt delivery.
RESULTS


The results showed that the intervention significantly reduced sedentary time in adolescents during the first week of the trial (t 17 =-1.79; P=.04; bootstrapped P=.02). This trend, although remaining positive, diminished over time. Our findings indicate that the intervention had no effect on metabolic equivalent of task-based MVPA minutes, although the descriptive increase may give reason for further investigation. Although the results suggested no overall change in heart rate-based MVPA minutes, the results from the change-point analyses suggest that the personalized PA prompts significantly increased heart rate per minute during the second week of the study (t 16 =1.84; P=.04; bootstrapped P=.04). There were no significant increases in participants' overall step count; however, the personalized PA prompts resulted in a marginally significant increase in step counts per minute in the second week of the study (t 17 =1.35; P=.09; bootstrapped P=.05).
CONCLUSIONS


The results of the trial provide preliminary evidence of the benefit of the Mobile App for Physical Activity intervention for modest yet significant reductions in participants' sedentary time and the beneficial role of personalized PA prompts. These results also provide further evidence of the benefits and relative efficacy of personalized activity suggestions for inclusion in smartphone-based PA interventions. This study provides an example of how to guide the development of smartphone-based mobile health PA interventions for adolescents.",2022,"There were no significant increases in participants' overall step count; however, the personalized PA prompts resulted in a marginally significant increase in step counts per minute in the second week of the study (t 17 =1.35; P=.09; bootstrapped P=.05).
","['adolescents', '18 healthy adolescents aged 16 to 18 years was conducted (mean age 16.33, SD 0.57 years', 'adolescents aged 16 to 18 years']","['smartphone-based mobile health PA interventions', 'Mobile App for Physical Activity intervention (Fitbit fitness tracker+app), which included a daily personalized PA prompt delivered via a pop-up notification', 'physical activity (PA', 'Personalized mHealth Intervention']","['heart rate per minute', 'step counts per minute', 'heart rate-based MVPA minutes', 'outcomes step count, sedentary time, and moderate to vigorous PA (MVPA) minutes', ""participants' overall step count"", 'sedentary time']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",18.0,0.0531285,"There were no significant increases in participants' overall step count; however, the personalized PA prompts resulted in a marginally significant increase in step counts per minute in the second week of the study (t 17 =1.35; P=.09; bootstrapped P=.05).
","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Domin', 'Affiliation': 'Research Group: Self-Regulation and Health, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Uslu', 'Affiliation': 'Research Group: Self-Regulation and Health, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Research Group: Self-Regulation and Health, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Yacine', 'Initials': 'Y', 'LastName': 'Ouzzahra', 'Affiliation': 'Research Support Department, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Research Group: Self-Regulation and Health, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}]",JMIR formative research,['10.2196/35118']
1589,35687394,Evaluation of the Web-Based OutsidePlay-ECE Intervention to Influence Early Childhood Educators' Attitudes and Supportive Behaviors Toward Outdoor Play: Randomized Controlled Trial.,"BACKGROUND


Outdoor play is critical to children's healthy development and well-being. Early learning and childcare centers (ELCCs) are important venues for increasing children's outdoor play opportunities, and early childhood educators' (ECE) perception of outdoor play can be a major barrier to outdoor play. The OutsidePlay-ECE risk-reframing intervention is a fully automated and open access web-based intervention to reframe ECEs' perceptions of the importance of outdoor play and risk in play and to promote a change in their practice in supporting it in ELCC settings. We grounded the intervention in social cognitive theory and behavior change techniques.
OBJECTIVE


The aim of this study is to evaluate the effectiveness of the OutsidePlay-ECE web-based risk-reframing intervention.
METHODS


We conducted a single-blind randomized controlled trial in Canada between December 2020 and June 2021 to test the OutsidePlay-ECE risk-reframing intervention for ECEs. We recruited participants using social media and mass emails through our partner and professional networks. We invited ECEs and administrators working in an ELCC, who can speak, read, and understand English. We randomized consented participants to the intervention or control condition. The participants allocated to the intervention condition received a link to the OutsidePlay-ECE intervention. Participants allocated to the control condition read the Position Statement on Active Outdoor Play, a 4-page document on research and recommendations for action in addressing barriers to outdoor play. The primary outcome was a change in tolerance of risk in play. The secondary outcome was goal attainment. We collected data on the web via REDCap (Vanderbilt University) at baseline and 1 week and 3 months after intervention.
RESULTS


A total of 563 participants completed the baseline survey, which assessed their demographics and tolerance of risk in play. They were then randomized: 281 (49.9%) to the intervention and 282 (50.1%) to the control condition. Of these, 136 (48.4%) and 220 (78%) participants completed the baseline requirements for the intervention and control conditions, respectively. At 1 week after intervention, 126 (44.8%) and 209 (74.1%) participants completed follow-up assessments, respectively, and at 3 months after intervention, 119 (42.3%) and 195 (69.1%) participants completed the assessments, respectively. Compared with participants in the control condition, participants in the intervention group had significantly higher tolerance of risk in play at 1 week (β=.320; P=.001) and 3 months after intervention (β=.251; P=.009). Intention-to-treat analyses replicated these findings (β=.335; P<.001 and β=.271; P=.004, respectively). No significant intervention effect was found for goal attainment outcomes (odds ratio 1.124, 95% CI 0.335-3.774; P=.85).
CONCLUSIONS


The results of this randomized controlled trial demonstrated that the OutsidePlay-ECE intervention was effective and had a sustained effect in increasing ECEs' and administrators' tolerance of risk in play. It was not effective in increasing goal attainment.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04624932; https://clinicaltrials.gov/ct2/show/NCT04624932.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/31041.",2022,"No significant intervention effect was found for goal attainment outcomes (odds ratio 1.124, 95% CI 0.335-3.774; P=.85).
","['Canada between December 2020 and June 2021 to test the OutsidePlay-ECE risk-reframing intervention for ECEs', '563 participants completed the baseline survey, which assessed their demographics and tolerance of risk in play', 'participants using social media and mass emails through our partner and professional networks']","['OutsidePlay-ECE web-based risk-reframing intervention', 'control condition read the Position Statement on Active Outdoor Play, a 4-page document on research and recommendations for action in addressing barriers to outdoor play', 'Web-Based OutsidePlay-ECE Intervention', 'OutsidePlay-ECE intervention', 'intervention condition received a link to the OutsidePlay-ECE intervention']","['change in tolerance of risk in play', 'goal attainment outcomes', 'tolerance of risk in play']","[{'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",563.0,0.133615,"No significant intervention effect was found for goal attainment outcomes (odds ratio 1.124, 95% CI 0.335-3.774; P=.85).
","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Brussoni', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Han', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Yingyi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Spatial Sciences Institute, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jacob', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Fritha', 'Initials': 'F', 'LastName': 'Munday', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Zeni', 'Affiliation': 'Faculty of Education, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Walters', 'Affiliation': 'Child Care Services, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Oberle', 'Affiliation': 'Human Early Learning Partnership, School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.'}]",Journal of medical Internet research,['10.2196/36826']
1590,35687390,Feedback on Trunk Movements From an Electronic Game to Improve Postural Balance in People With Nonspecific Low Back Pain: Pilot Randomized Controlled Trial.,"BACKGROUND


Postural balance is compromised in people with low back pain, possibly by changes in motor control of the trunk. Augmenting exercising interventions with sensor-based feedback on trunk posture and movements might improve postural balance in people with low back pain.
OBJECTIVE


We hypothesized that exercising with feedback on trunk movements reduces sway in anterior-posterior direction during quiet standing in people with low back pain. Secondary outcomes were lumbar spine and hip movement assessed during box lift and waiter bow tasks, as well as participant-reported outcomes. Adherence to the exercising intervention was also examined.
METHODS


A randomized controlled trial was conducted with the intervention group receiving unsupervised home exercises with visual feedback using the Valedo Home, an exergame based on 2 inertial measurement units. The control group received no intervention. Outcomes were recorded by blinded staff during 4 visits (T1-T4) at University Hospital Zurich. The intervention group performed 9 sessions of 20 minutes in the 3 weeks between T2 and T3 and were instructed to exercise at their own convenience between T3 and T4. Postural balance was assessed on a force platform. Lumbar spine and hip angles were obtained from 3 inertial measurement units. The assessments included pain intensity, disability, quality of life, and fear of movement questionnaires.
RESULTS


A total of 32 participants with nonspecific low back pain completed the first assessment T1, and 27 (84%) participants were randomized at T2 (n=14, 52% control and n=13, 48% intervention). Intention-to-treat analysis revealed no significant difference in change in anterior-posterior sway direction during the intervention period with a specified schedule (T2-T3) between the groups (W=99; P=.36; r=0.07). None of the outcomes showed significant change in accordance with our hypotheses. The intervention group completed a median of 61% (55/90; range 2%-99%) of the exercises in the predefined training program. Adherence was higher in the first intervention period with a specified schedule.
CONCLUSIONS


The intervention had no significant effect on postural balance or other outcomes, but the wide range of adherence and a limited sample size challenged the robustness of these conclusions. Future work should increase focus on improving adherence to digital interventions.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04364243; https://clinicaltrials.gov/ct2/show/NCT04364243.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/26982.",2022,Intention-to-treat analysis revealed no significant difference in change in anterior-posterior sway direction during the intervention period with a specified schedule (T2-T3) between the groups (W=99; P=.36; r=0.07).,"['32 participants with nonspecific low back pain completed the first assessment T1, and 27 (84%) participants', 'People With Nonspecific Low Back Pain', 'people with low back pain']","['Feedback on Trunk Movements From an Electronic Game', 'Augmenting exercising interventions with sensor-based feedback on trunk posture and movements', 'no intervention', 'intervention group receiving unsupervised home exercises with visual feedback using the Valedo Home']","['Adherence', 'pain intensity, disability, quality of life, and fear of movement questionnaires', 'lumbar spine and hip movement assessed during box lift and waiter bow tasks, as well as participant-reported outcomes', 'Lumbar spine and hip angles', 'postural balance', 'anterior-posterior sway direction', 'Postural balance', 'Postural Balance']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0575119', 'cui_str': 'Truncal posture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439755', 'cui_str': 'Directions'}]",32.0,0.116488,Intention-to-treat analysis revealed no significant difference in change in anterior-posterior sway direction during the intervention period with a specified schedule (T2-T3) between the groups (W=99; P=.36; r=0.07).,"[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Meinke', 'Affiliation': 'Mobile Health Systems Lab, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Peters', 'Affiliation': 'Department of Physiotherapy Occupational Therapy, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ruud H', 'Initials': 'RH', 'LastName': 'Knols', 'Affiliation': 'Department of Physiotherapy Occupational Therapy, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Swanenburg', 'Affiliation': 'Directorate of Research and Education, Physiotherapy Occupational Therapy Research Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Karlen', 'Affiliation': 'Mobile Health Systems Lab, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.'}]",JMIR serious games,['10.2196/31685']
1591,35688056,Effect of yoga on cognitive functions and anxiety among female school children with low academic performance: A randomized control trial.,"BACKGROUND


To achieve better academic performance, students should improve their cognitive faculties and overcome anxiety. Therefore, the present research was conducted to assess the effect of yoga on the cognitive functions of female adolescents with low academic performance.
METHODS


The present study is a randomized control trial (RCT). Eighty-nine female students in the age range of 12-14 years were randomly assigned into two groups [yoga (n = 45); physical exercise (n = 44)] at a school setting. Both groups were assessed before and after on Raven's standard progressive matrices (RSPM), Corsi Block Tapping Test (CBTT), Six Letter Cancellation Test (SLCT), Digit Letter Substitution Test (DLST), Stroop Color and Word Test (SCWT), and State-Trait Anxiety Inventory for Children (STAIC).
RESULTS


Findings of the present study showed significant (p < .05) differences in scores of forward CBTT, SWCT, and SLCT in group × time interaction. Both the groups showed significant (p < .05) improvement in SLCT, backward scores of CBTT, and STAIC-T. All outcomes measured were significantly (p < .05) improved in the yoga group except STAIC-S.
CONCLUSION


Yoga improves general intelligence, visuospatial working memory, and attention, as well as reduces the anxiety of students with low academic performance. Similarly, physical exercise was also found to be improving visuospatial working memory, sustained attention, and reduce trait anxiety. However, the finding of the present study indicated yoga to be more effective compared to physical exercise in regards to students' fluid intelligence and executive function. Improvement in general intelligence, visuospatial working memory, and attention is expected to positively influence students' academic performance.",2022,Both the groups showed significant (p < .05),"['female adolescents with low academic performance', 'Eighty-nine female students in the age range of 12-14 years', 'female school children with low academic performance']","['physical exercise', 'yoga', 'yoga (n\xa0=\xa045); physical exercise']","['SLCT, backward scores of CBTT, and STAIC-T', 'general intelligence, visuospatial working memory, and attention, as well as reduces the anxiety of students with low academic performance', 'cognitive functions and anxiety', ""general intelligence, visuospatial working memory, and attention is expected to positively influence students' academic performance"", 'progressive matrices (RSPM), Corsi Block Tapping Test (CBTT), Six Letter Cancellation Test (SLCT), Digit Letter Substitution Test (DLST), Stroop Color and Word Test (SCWT), and State-Trait Anxiety Inventory for Children (STAIC', 'visuospatial working memory, sustained attention, and reduce trait anxiety']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0451260', 'cui_str': 'Letter cancelation test'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C1449597', 'cui_str': 'Corvus corax'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}]",89.0,0.0318419,Both the groups showed significant (p < .05),"[{'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Parajuli', 'Affiliation': 'Centre for Integrative Medicine and Research (CIMR), AIIMS, New Delhi, India. Electronic address: ranjan.happy1@gmail.com.'}, {'ForeName': 'Balaram', 'Initials': 'B', 'LastName': 'Pradhan', 'Affiliation': 'Division of Yoga and Humanities, SVYASA, Bangalore, India.'}, {'ForeName': 'Saee', 'Initials': 'S', 'LastName': 'Bapat', 'Affiliation': 'Division of Yoga and Humanities, SVYASA, Bangalore, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2022.101614']
1592,35688598,"Therapy of genomic unstable solid tumours (WHO grade 3/4）in clinical stage III/IV using individualised neoantigen tumour peptides-INP trial (individualised neoantigen tumour peptides immunotherapy): study protocol for an open-label, non-randomised, prospective, single-arm trial.","INTRODUCTION


Neoantigens derived from tumour somatic mutations are recognised as ideal vaccine targets. Tumour neoantigens have been studied in a wide range of tumours. Most of research on neoantigens has focused just on a unique tumour and a single mutated gene. Currently, a few studies have reported using a mixture of neoantigen peptides derived from multiple genetic mutation sites in the treatment of genomic unstable advanced solid malignancies. The trial aims to evaluate the safety and efficacy of individualised tumour neoantigen peptide mixtures in the treatment of genomic unstable advanced solid malignant tumours.
METHODS AND ANALYSIS


This is a prospective, non-randomised, open, single-centre, single-arm, phase I trial. Patients with genomic unstable advanced solid malignancies are eligible for study participations. 20 patients will be included in the trial. Through the whole exome and transcriptome sequencing analysis of the fresh blood and tumour tissues of the enrolled patients, the 20 25-33aa antigen peptides with the highest mutation scores of the patients will be screened out, and the corresponding new antigen peptides will be synthesised and prepared. Patients will be treated with their own individualised neoantigen polypeptide combined with a polypeptide adjuvant (human granulocyte-macrophage colony-stimulating factor). The primary endpoint is safety indicators, including general and specific adverse events which will be monitored continuously. Secondary endpoints are progression-free survival, objective response rate, objective duration of remission, 1-year survival rate and overall survival.
ETHICS AND DISSEMINATION


This study has received approval from the Ethics Committee of Chongqing University Cancer Hospital on 21 November 2019 (207/2019). The findings of this trial will be disseminated through national and international presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER


ChiCTR1900025364.",2022,"The trial aims to evaluate the safety and efficacy of individualised tumour neoantigen peptide mixtures in the treatment of genomic unstable advanced solid malignant tumours.
","['Patients with genomic unstable advanced solid malignancies are eligible for study participations', '20 patients will be included in the trial', 'genomic unstable advanced solid malignant tumours', 'Chongqing University Cancer Hospital on 21 November 2019 (207/2019']","['polypeptide adjuvant (human granulocyte-macrophage colony-stimulating factor', 'individualised tumour neoantigen peptide mixtures']","['progression-free survival, objective response rate, objective duration of remission, 1-year survival rate and overall survival', 'safety indicators, including general and specific adverse events', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}]","[{'cui': 'C1305923', 'cui_str': 'Polypeptide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0312555', 'cui_str': 'Neoantigen'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",20.0,0.27115,"The trial aims to evaluate the safety and efficacy of individualised tumour neoantigen peptide mixtures in the treatment of genomic unstable advanced solid malignant tumours.
","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Phase I Clinical Trial Ward, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Trial Center, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Phase I Clinical Trial Ward, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Wanyan', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Phase I Clinical Trial Ward, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liao', 'Affiliation': 'Department of Phase I Clinical Trial Ward, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Weiqi', 'Initials': 'W', 'LastName': 'Nian', 'Affiliation': 'Department of Phase I Clinical Trial Ward, Chongqing University Cancer Hospital, Chongqing, China nwqone@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2021-055742']
1593,35688593,Acceptance commitment therapy (ACT) for psychological distress associated with inflammatory bowel disease (IBD): protocol for a feasibility trial of the ACTforIBD programme.,"INTRODUCTION


Inflammatory bowel disease (IBD) involves an abnormal immune response to healthy gut bacteria. When a person develops IBD, their susceptibility to anxiety and/or depression increases. The ACTforIBD programme, specifically designed for people with IBD and comorbid psychological distress, draws on acceptance and commitment therapy (ACT), which promotes acceptance of situations that cannot be solved such as persistent physical symptoms. There are no ACT trials for IBD using an active control group or a telemedicine approach, which is important to improve accessibility, particularly in the context of the ongoing COVID-19 pandemic. The ACTforIBD programme is administered online with a 4-hour therapist involvement per participant only; if successful it can be widely implemented to improve the well-being of many individuals with IBD.
METHODS AND ANALYSIS


Our team have codesigned with consumers the ACTforIBD programme, an 8-week intervention of 1-hour sessions, with the first three sessions and the last session delivered one-to-one by a psychologist, and the other sessions self-directed online. This study aims to evaluate the feasibility and preliminary efficacy of ACTforIBD to reduce psychological distress in patients with IBD. Using a randomised controlled trial, 25 participants will be randomised to ACTforIBD, and 25 patients to an active control condition.
ETHICS AND DISSEMINATION


This protocol has been approved by Deakin University Research Ethics Committee in September 2021 (Ref. 2021-263) and the New Zealand Central Health and Disability Ethics Committee in December 2021 (Ref. 2021 EXP 11384). The results of this research will be published in peer-reviewed journals and shared with various stakeholders, including community members, policy-makers and researchers, through local and international conferences.
TRIAL REGISTRATION NUMBER


ACTRN12621001316897.",2022,"The ACTforIBD programme, specifically designed for people with IBD and comorbid psychological distress, draws on acceptance and commitment therapy (ACT), which promotes acceptance of situations that cannot be solved such as persistent physical symptoms.","['2021-263) and the New Zealand Central Health and Disability Ethics Committee in December 2021 (Ref', 'people with IBD and comorbid psychological distress', '25 participants will be randomised to ACTforIBD, and 25 patients to an active control condition.\nETHICS AND DISSEMINATION', 'patients with IBD', 'psychological distress associated with inflammatory bowel disease (IBD', '2021']","['Acceptance commitment therapy (ACT', 'ACTforIBD']",['psychological distress'],"[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",25.0,0.0925279,"The ACTforIBD programme, specifically designed for people with IBD and comorbid psychological distress, draws on acceptance and commitment therapy (ACT), which promotes acceptance of situations that cannot be solved such as persistent physical symptoms.","[{'ForeName': 'Subhadra', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'Psychology, Deakin University Faculty of Health, Burwood, Victoria, Australia subhadra.evans@deakin.edu.au.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Olive', 'Affiliation': 'School of Pyschology, Deakin, Geelong, Victoria, Australia.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Dober', 'Affiliation': 'School of Psychology, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Knowles', 'Affiliation': 'School of Health Sciences, Swinburne University of Technology, Hawthorn, Victoria, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'School of Psychology, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'O', 'Affiliation': 'Faculty of Health, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibson', 'Affiliation': 'Gastroenterology, Monash University Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Raven', 'Affiliation': ""Crohn's and Colitis Australia, Camberwell, Victoria, Australia.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gearry', 'Affiliation': 'Department of Medicine, Christchurch School of Medicine and Health Sciences, Medicine, Christchurch, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McCombie', 'Affiliation': 'Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Leesa', 'Initials': 'L', 'LastName': 'van Niekerk', 'Affiliation': 'School of Psychological Sciences, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chesterman', 'Affiliation': 'School of Pyschology, Deakin, Geelong, Victoria, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Romano', 'Affiliation': 'School of Pyschology, Deakin, Geelong, Victoria, Australia.'}, {'ForeName': 'Antonina', 'Initials': 'A', 'LastName': 'Mikocka-Walus', 'Affiliation': 'Psychology, Deakin University Faculty of Health, Burwood, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2021-060272']
1594,35688585,Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-Based Context (TrainStim-Home): study protocol for a randomised controlled trial.,"INTRODUCTION


With the worldwide increase of life expectancy leading to a higher proportion of older adults experiencing age-associated deterioration of cognitive abilities, the development of effective and widely accessible prevention and therapeutic measures has become a priority and challenge for modern medicine. Combined interventions of cognitive training and transcranial direct current stimulation (tDCS) have shown promising results for counteracting age-associated cognitive decline. However, access to clinical centres for repeated sessions is challenging, particularly in rural areas and for older adults with reduced mobility, and lack of clinical personnel and hospital space prevents extended interventions in larger cohorts. A home-based and remotely supervised application of tDCS would make the treatment more accessible for participants and relieve clinical resources. So far, studies assessing feasibility of combined interventions with a focus on cognition in a home-based setting are rare. With this study, we aim to provide evidence for the feasibility and the effects of a multisession home-based cognitive training in combination with tDCS on cognitive functions of healthy older adults.
METHODS AND ANALYSIS


The TrainStim-Home trial is a monocentric, randomised, double-blind, placebo-controlled study. Thirty healthy participants, aged 60-80 years, will receive 2 weeks of combined cognitive training and anodal tDCS over left dorsolateral prefrontal cortex (target intervention), compared with cognitive training plus sham stimulation. The cognitive training will comprise a letter updating task, and the participants will be stimulated for 20 min with 1.5 mA. The intervention sessions will take place at the participants' home, and primary outcome will be the feasibility, operationalised by two-thirds successfully completed sessions per participant. Additionally, performance in the training task and an untrained task will be analysed.
ETHICS AND DISSEMINATION


Ethical approval was granted by the ethics committee of the University Medicine Greifswald. Results will be available through publications in peer-reviewed journals and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER


NCT04817124.",2022,"Thirty healthy participants, aged 60-80 years, will receive 2 weeks of combined cognitive training and anodal tDCS over left dorsolateral prefrontal cortex (target intervention), compared with cognitive training plus sham stimulation.","['Thirty healthy participants, aged 60-80 years', 'healthy older adults']","['Transcranial Direct Current Stimulation', 'Cognitive Training', 'cognitive training plus sham stimulation', 'multisession home-based cognitive training in combination with tDCS', 'combined cognitive training and anodal tDCS over left dorsolateral prefrontal cortex (target intervention', 'cognitive training and transcranial direct current stimulation (tDCS', 'placebo']","['cognitive abilities', 'cognitive functions']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",30.0,0.0846048,"Thirty healthy participants, aged 60-80 years, will receive 2 weeks of combined cognitive training and anodal tDCS over left dorsolateral prefrontal cortex (target intervention), compared with cognitive training plus sham stimulation.","[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Thams', 'Affiliation': 'Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Rocke', 'Affiliation': 'Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Malinowski', 'Affiliation': 'Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Nowak', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Grittner', 'Affiliation': 'Berlin Institute of Health, Charité - University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Antonenko', 'Affiliation': 'Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Flöel', 'Affiliation': 'Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany agnes.floeel@med.uni-greifswald.de.'}]",BMJ open,['10.1136/bmjopen-2021-059943']
1595,35688582,Nissen-Sleeve procedure versus laparoscopic Roux-en-Y gastric bypass in patients with morbid obesity and gastro-oesophageal reflux disease: protocol for a non-inferiority randomised trial (GINSBY).,"INTRODUCTION


Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most frequently performed procedures in bariatric surgery. In patients with morbid obesity and gastro-oesophageal reflux disease (GORD), LRYGB is the most accepted procedure. For patients with a contraindication for LRYGB or a strong preference for LSG, the Nissen-Sleeve procedure may be a viable new option. The aim of this study is to compare effectiveness of Nissen-Sleeve with LRYGB.
METHOD AND ANALYSIS


This is a single-centre, phase III, parallel-group randomised controlled trial in a high-volume bariatric centre in the Netherlands. A total of 88 patients with morbid obesity and GORD will be randomised to evaluate non-inferiority of Nissen-Sleeve versus LRYGB (non-inferiority margin 15%, power 80%, one-sided α 0.025, 9% drop out). Patients with morbid obesity aged 18 years and older with GORD according to the Montreal definition will be included after obtaining informed consent. Exclusion criteria are achalasia, neoplastic abnormalities diagnosed during endoscopy, super obesity (body mass index ≥50 kg/m 2 ), Crohn's disease and medical history of major abdominal surgery. After randomisation, all patients will undergo an upper gastrointestinal endoscopy. Patients in the Nissen-Sleeve arm will undergo a timed barium oesophagram to exclude oesophageal motility disorders. Patients will complete six questionnaires at baseline and every year until 5 years of follow-up. At day 1 postoperative, patients in the Nissen-Sleeve arm will undergo a swallow X-ray to confirm passage. At 1 year, all patients will undergo another endoscopy. The primary outcome is GORD status. Absence of GORD is defined as <8 points on the GORD questionnaire. Secondary outcome measures are long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A-D) and/or presence of Barrett's oesophagus and cost-effectiveness.
ETHICS AND DISSEMINATION


The protocol was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 15 September 2021. Written informed consent will be obtained for all participants in the study. The study results will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NL9789; The Netherlands Trial Registry.",2022,"Secondary outcome measures are long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A-D) and/or presence of Barrett's oesophagus and cost-effectiveness.
","['88 patients with morbid obesity and GORD', 'Patients with morbid obesity aged 18 years and older with GORD according to the Montreal definition', ""Exclusion criteria are achalasia, neoplastic abnormalities diagnosed during endoscopy, super obesity (body mass index ≥50\u2009kg/m 2 ), Crohn's disease and medical history of major abdominal surgery"", 'For patients with a contraindication for LRYGB or a strong preference for LSG', 'patients with morbid obesity and gastro-oesophageal reflux disease', 'patients with morbid obesity and gastro-oesophageal reflux disease (GORD']","['Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB', 'Nissen-Sleeve arm will undergo a timed barium oesophagram', 'Nissen-Sleeve with LRYGB', 'Nissen-Sleeve versus LRYGB', 'Nissen-Sleeve procedure versus laparoscopic Roux-en-Y gastric bypass']","[""long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A-D) and/or presence of Barrett's oesophagus and cost-effectiveness"", 'GORD status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0014848', 'cui_str': 'Achalasia of esophagus'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004749', 'cui_str': 'Barium'}, {'cui': 'C1318509', 'cui_str': 'Contrast radiography of esophagus'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",88.0,0.0881778,"Secondary outcome measures are long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A-D) and/or presence of Barrett's oesophagus and cost-effectiveness.
","[{'ForeName': 'Judith W H', 'Initials': 'JWH', 'LastName': ""'t Hart"", 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands j.hart@franciscus.nl.'}, {'ForeName': 'Bo J', 'Initials': 'BJ', 'LastName': 'Noordman', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Laser U', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Ivonne', 'Initials': 'I', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Gastroenterology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dunkelgrun', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Apers', 'Affiliation': 'Surgery, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2022-061499']
1596,35688526,Oligometastatic Breast Cancer.,"Oligometastatic breast cancer is typically defined as the presence of 1-5 metastases and represents an intermediate state between locally advanced and widely metastatic disease. Oligometastatic cancer appears have a molecular signature that is distinct from widely metastatic disease and is associated with a superior prognosis. Due to its more limited capacity for widespread progression, oligometastatic disease could potentially benefit from aggressive ablative therapy to known sites of disease. The phase II SABR-COMET trial enrolled patients with oligometastatic disease of multiple histologies and randomized them to HIGRT vs. standard of care, finding a notable survival advantage in favor of HIGRT. There are many ongoing trials exploring the role of HIGRT for the treatment of oligometastatic breast cancer. Future studies may identify optimal candidates for ablative therapy by molecular signature; current clinically-based selection criteria include longer disease-free interval from diagnosis to metastasis (>2 years), fewer metastases, and fewer involved organs.",2022,"Due to its more limited capacity for widespread progression, oligometastatic disease could potentially benefit from aggressive ablative therapy to known sites of disease.","['Oligometastatic Breast Cancer', 'patients with oligometastatic disease of multiple histologies']",['HIGRT'],[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019638', 'cui_str': 'Histology'}]",[],[],,0.223349,"Due to its more limited capacity for widespread progression, oligometastatic disease could potentially benefit from aggressive ablative therapy to known sites of disease.","[{'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Strauss', 'Affiliation': 'Department of Radiation Oncology, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL 60611. Electronic address: jstrauss@nm.org.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Chmura', 'Affiliation': 'Department of Radiation and Cellular Oncology, University of Chicago, Chicago IL, 60637.'}]",Seminars in radiation oncology,['10.1016/j.semradonc.2022.01.008']
1597,35688490,Impact of micronised progesterone and medroxyprogesterone acetate in combination with transdermal oestradiol on cardiovascular markers in women diagnosed with premature ovarian insufficiency or an early menopause: a randomised pilot trial.,"OBJECTIVE


To compare the difference between micronised progesterone (MP) and medroxyprogesterone acetate (MPA) in combination with transdermal oestradiol (t-E 2 ) on cardiovascular disease (CVD) risk markers in women diagnosed with an early menopause and premature ovarian insufficiency (EMPOI).
BACKGROUND


The European Society for Cardiology has identified carotid femoral pulse wave velocity (cfPWV) as the gold standard cardiogenic biomarker for risk stratification of arterial disease. Menopause has been shown to augment the age-dependent increase in arterial stiffness, with hormone replacement therapy (HRT) being the mainstay of management of women diagnosed with EMPOI.
STUDY DESIGN


A pilot randomised prospective open-label trial. Women were randomised to either cyclical MP (Utrogestan® 200mg) or MPA (Provera® 10mg) in conjunction with t-E 2  (Evorel® Patches 50mcg/day) for 12 months. Seventy-one subjects were screened, and baseline data are available for 57 subjects.
MAIN OUTCOME MEASURE


Carotid-femoral pulse wave velocity (cfPWV).
RESULTS


PWV did not significantly change from baseline in either treatment arm. MP + t-E 2  demonstrated a positive effect on traditional CVD markers, with a significant improvement seen in cardiac output (CO) (0.71±1.01mL/min, 95% CI 0.20 to 1.21) and reduction in diastolic blood pressure (DBP) (-3.43±6.31mmHg, 95% Cl -6.57 to -0.29) and total peripheral resistance (TPR) (-0.15±0.19mmHg⋅min⋅mL -1 , 95% CI -0.24 to -0.05) after 12 months. MPA + t-E 2 , in contrast, did not demonstrate significant changes from baseline in traditional haemodynamic parameters.
CONCLUSION


The positive changes in traditional markers were not reflected in the cardiogenic biomarker, cfPWV, which has demonstrated a higher positive predictive value for cardiovascular events than traditional measurements.",2022,"MP + t-E 2  demonstrated a positive effect on traditional CVD markers, with a significant improvement seen in cardiac output (CO) (0.71±1.01mL/min, 95% CI 0.20 to 1.21) and reduction in diastolic blood pressure (DBP) (-3.43±6.31mmHg, 95%","['women diagnosed with premature ovarian insufficiency or an early menopause', 'women diagnosed with an early menopause and premature ovarian insufficiency (EMPOI', 'Seventy-one subjects were screened, and baseline data are available for 57 subjects']","['cyclical MP (Utrogestan® 200mg) or MPA (Provera® 10mg) in conjunction with t-E 2  (Evorel®', 'transdermal oestradiol (t-E 2 ', 'micronised progesterone (MP) and medroxyprogesterone acetate (MPA', 'transdermal oestradiol', 'hormone replacement therapy (HRT', 'micronised progesterone and medroxyprogesterone acetate']","['traditional CVD markers', 'Carotid-femoral pulse wave velocity (cfPWV', 'PWV', 'cardiovascular markers', 'diastolic blood pressure (DBP', 'cardiovascular disease (CVD) risk markers', 'cardiac output (CO', 'total peripheral resistance (TPR) ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C1515400', 'cui_str': 'Utrogestan'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0699702', 'cui_str': 'Provera'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}]",71.0,0.147592,"MP + t-E 2  demonstrated a positive effect on traditional CVD markers, with a significant improvement seen in cardiac output (CO) (0.71±1.01mL/min, 95% CI 0.20 to 1.21) and reduction in diastolic blood pressure (DBP) (-3.43±6.31mmHg, 95%","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Mittal', 'Affiliation': ""Imperial College Healthcare NHS Trust, St Mary's and Hammersmith Hospitals, Department of Obstetrics and Gynaecology, Praed Street, London W2 1NY. Electronic address: monica.mittal@nhs.net.""}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'McEniery', 'Affiliation': ""University of Cambridge, Division of Cardiovascular Medicine, Addenbrooke's Hospital, Cambridge, Hills Road, Cambridge CB2 0QQ.""}, {'ForeName': 'Prasanna Raj', 'Initials': 'PR', 'LastName': 'Supramaniam', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Department of Obstetrics and Gynaecology, Headley Way, Headington, Oxford OX3 9DU.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cardozo', 'Affiliation': ""King's College Hospital NHS Foundation Trust, Department of Obstetrics and Gynaecology, Denmark Hill, Brixton, London SE5 9RS.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Savvas', 'Affiliation': ""King's College Hospital NHS Foundation Trust, Department of Obstetrics and Gynaecology, Denmark Hill, Brixton, London SE5 9RS.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Panay', 'Affiliation': ""Imperial College Healthcare NHS Trust and Chelsea and Westminster NHS Foundation Trust, Queen Charlotte's and Chelsea Hospital, Department of Obstetrics and Gynaecology, Du Cane Rd, White City, London W12 0HS.""}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Hamoda', 'Affiliation': ""King's College Hospital NHS Foundation Trust, Department of Obstetrics and Gynaecology, Denmark Hill, Brixton, London SE5 9RS.""}]",Maturitas,['10.1016/j.maturitas.2022.01.012']
1598,35689084,Fostering eating after stroke (FEASt) trial for improving post-stroke dysphagia with non-invasive brain stimulation.,"Dysphagia is a serious stroke complication but lacks effective therapy. We investigated safety and preliminary efficacy of anodal transcranial direct current stimulation (atDCS) paired with swallowing exercises in improving post-stroke dysphagia from an acute unilateral hemispheric infarction (UHI). We conducted a double-blind, early phase-2 randomized controlled trial, in subjects (n = 42) with moderate-severe dysphagia [Penetration and Aspiration Scale (PAS) score ≥ 4], from an acute-subacute UHI. Subjects were randomized to Low-Dose, High-Dose atDCS or Sham stimulation for 5 consecutive days. Primary safety outcomes were incidence of seizures, neurological, motor, or swallowing function deterioration. Primary efficacy outcome was a change in PAS scores at day-5 of intervention. Main secondary outcome was dietary improvement at 1-month, assessed by Functional Oral Intake (FOIS) score. No differences in pre-defined safety outcomes or adjusted mean changes in PAS, FOIS scores, between groups, were observed. Post-hoc analysis demonstrated that 22 /24 subjects in the combined atDCS group had a clinically meaningful dietary improvement (FOIS score ≥ 5) compared to 8 /14 in Sham (p = 0.037, Fisher-exact). atDCS application in the acute-subacute stroke phase is safe but did not decrease risk of aspiration in this early phase trial. The observed dietary improvement is promising and merits further investigation.",2022,"No differences in pre-defined safety outcomes or adjusted mean changes in PAS, FOIS scores, between groups, were observed.","['subjects (n\u2009=\u200942) with moderate-severe dysphagia [Penetration and Aspiration Scale (PAS) score\u2009≥\u20094], from an acute-subacute UHI', 'acute unilateral hemispheric infarction (UHI']","['Low-Dose, High-Dose atDCS or Sham stimulation', 'anodal transcranial direct current stimulation (atDCS) paired with swallowing exercises']","['incidence of seizures, neurological, motor, or swallowing function deterioration', 'PAS, FOIS scores', 'dietary improvement at 1-month, assessed by Functional Oral Intake (FOIS) score', 'PAS scores']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0589276', 'cui_str': 'Swallowing exercises'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",42.0,0.157008,"No differences in pre-defined safety outcomes or adjusted mean changes in PAS, FOIS scores, between groups, were observed.","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Neurology, Stroke Division, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Palmer 127, Boston, MA, 02215, USA. skumar@bidmc.harvard.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marchina', 'Affiliation': 'Department of Neurology, Stroke Division, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Palmer 127, Boston, MA, 02215, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Langmore', 'Affiliation': 'Department of Otolaryngology, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Massaro', 'Affiliation': 'Biostatistics, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Palmisano', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center (BEDAC), Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center (BEDAC), Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David Eric', 'Initials': 'DE', 'LastName': 'Searls', 'Affiliation': 'Department of Neurology, Stroke Division, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Palmer 127, Boston, MA, 02215, USA.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Lioutas', 'Affiliation': 'Department of Neurology, Stroke Division, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Palmer 127, Boston, MA, 02215, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pisegna', 'Affiliation': 'Department of Otolaryngology, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Wagner', 'Affiliation': 'Department of Neurology, Stroke Division, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Palmer 127, Boston, MA, 02215, USA.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Shinde', 'Affiliation': 'Department of Neurology, UMass Chan Medical School-Baystate, Springfield, MA, USA.'}, {'ForeName': 'Gottfried', 'Initials': 'G', 'LastName': 'Schlaug', 'Affiliation': 'Department of Neurology, UMass Chan Medical School-Baystate, Springfield, MA, USA.'}]",Scientific reports,['10.1038/s41598-022-14390-9']
1599,35689033,Comparative clinical and radiographic outcomes between early and delayed wrist mobilization after volar fixed-angle plate fixation of distal radius fracture.,"Postoperative immobilization protocols after volar fixed-angle plate fixation of distal radius fractures (DRF) vary among surgeons. This study aimed to compare functional outcomes, radiographic parameters, and complications between early and delayed mobilization after volar fixed-angle plate fixation of DRF. This study is a randomized controlled trial. The early group was allowed to perform wrist motion exercise immediately after surgery and the delayed group was allowed to perform it after 2 weeks of external immobilization. Postoperative patient-rated wrist evaluation (PRWE), disabilities of arm, shoulder, and hand (DASH), wrist range of motion, visual analog scale (VAS) pain score, and grip strength were evaluated. Forty-eight patients with DRF were enrolled and randomly allocated to the early or delayed mobilization groups. The PRWE, DASH, VAS pain score, grip strength, and wrist motion of both groups significantly improved over time. However, there were no significant differences between groups at any timepoint. Radiographic parameters were not different between groups. There were no significant differences in functional outcomes, radiographic parameters, and complications between early and delayed mobilization after volar fixed-angle plate of DRF. Immediate postoperative wrist range-of-motion exercise can be safely initiated after volar fixed-angle plate fixation of DRF without external immobilization.Clinical trial registration: Thaiclinicaltrials.org identifier: TCTR20180927005. Registered 27/09/2018-retrospectively registered. https://www.thaiclinicaltrials.org/show/TCTR20180927005 .",2022,"The PRWE, DASH, VAS pain score, grip strength, and wrist motion of both groups significantly improved over time.","['distal radius fracture', 'Thaiclinicaltrials.org identifier', 'distal radius fractures (DRF) vary among surgeons', 'Forty-eight patients with DRF']","['wrist motion exercise', 'Immediate postoperative wrist range-of-motion exercise']","['functional outcomes, radiographic parameters, and complications between early and delayed mobilization', 'PRWE, DASH, VAS pain score, grip strength, and wrist motion of both groups significantly improved over time', 'Postoperative patient-rated wrist evaluation (PRWE), disabilities of arm, shoulder, and hand (DASH), wrist range of motion, visual analog scale (VAS) pain score, and grip strength', 'Radiographic parameters']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0575717', 'cui_str': 'Wrist joint - range of movement'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0575717', 'cui_str': 'Wrist joint - range of movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",48.0,0.0158219,"The PRWE, DASH, VAS pain score, grip strength, and wrist motion of both groups significantly improved over time.","[{'ForeName': 'Panai', 'Initials': 'P', 'LastName': 'Laohaprasitiporn', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. panai.lao@mahidol.edu.'}, {'ForeName': 'Kitidate', 'Initials': 'K', 'LastName': 'Boonchai', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Yuwarat', 'Initials': 'Y', 'LastName': 'Monteerarat', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Roongsak', 'Initials': 'R', 'LastName': 'Limthongthang', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Torpon', 'Initials': 'T', 'LastName': 'Vathana', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Scientific reports,['10.1038/s41598-022-13909-4']
1600,35693609,"Study design for a multicenter, randomized controlled trial evaluating the diagnostic value of ultrathin bronchoscope compared to thin bronchoscope without fluoroscopy for peripheral pulmonary lesions.","Background


Ultrathin bronchoscope (UTB) with a 3.0-mm outer diameter and a 1.7-mm working channel currently appeared as a potential tool for better biopsy and diagnosis of peripheral pulmonary lesions (PPLs) by accessing more distal bronchus. However, published research is primarily limited to diagnosis value of UTB for PPLs with fluoroscopy, the value of UTB compared with thin bronchoscope (TB) without fluoroscopy guidance has not been determined yet.
Methods


We design a prospective, randomized, controlled, non-inferior, multicenter study aiming to evaluate the diagnostic value and safety of UTB for PPLs with the guidance of virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) without fluoroscopy by comparing to TB. The study aims to enroll 578 patients presenting for evaluation of PPLs at five clinical sites in China. Subjects will be randomized to UTB-VBN-EBUS group, TB-VBN-EBUS-guide sheath (GS) group, and TB-VBN-EBUS-non-GS group. Primary endpoint is the diagnostic yield of PPLs. The total examination time, duration of finding lesions, the proportion of lesions visible by radial EBUS, factors affecting the diagnostic yield, difference in the bronchus level reached with the bronchoscope, difference in diagnostic yield, and complication rate will be determined as secondary endpoints. The primary endpoint will be followed-up at least 6-month post-procedure and 1-month post-procedure for safety endpoint.
Discussion


Study enrollment began in March 2021. Our preliminary experience reveals that UTB is a powerful tool in the diagnosis of PPLs even without fluoroscopy. The results of the current study will compensate the limitations of the previous research, further provide evidence of UTB in diagnosing PPLs without fluoroscopy.
Trial Registration


ClinicalTrials.gov NCT04571476. Registered on 30 September 2020.",2022,"The total examination time, duration of finding lesions, the proportion of lesions visible by radial EBUS, factors affecting the diagnostic yield, difference in the bronchus level reached with the bronchoscope, difference in diagnostic yield, and complication rate will be determined as secondary endpoints.","['578 patients presenting for evaluation of PPLs at five clinical sites in China', 'peripheral pulmonary lesions']","['thin bronchoscope without fluoroscopy', 'UTB', '\n\n\nUltrathin bronchoscope (UTB', 'ultrathin bronchoscope', 'virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) without fluoroscopy']","['diagnostic yield, and complication rate', 'diagnostic yield of PPLs', 'total examination time, duration of finding lesions, the proportion of lesions visible by radial EBUS, factors affecting the diagnostic yield, difference in the bronchus level', 'followed-up at least 6-month post-procedure and 1-month post-procedure for safety endpoint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscope'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0006255', 'cui_str': 'Bronchial structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0906384,"The total examination time, duration of finding lesions, the proportion of lesions visible by radial EBUS, factors affecting the diagnostic yield, difference in the bronchus level reached with the bronchoscope, difference in diagnostic yield, and complication rate will be determined as secondary endpoints.","[{'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Respiratory Endoscopy, Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Endoscopy, Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Fengming', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaoju', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Henan Provincial People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Endoscopy, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory Endoscopy, Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jiayuan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Respiratory Endoscopy, Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shiyue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Diseases, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",Journal of thoracic disease,['10.21037/jtd-22-20']
1601,35693576,Postpartum Care Behavior Improvement during COVID-19 Pandemic in Indonesia Using Mobile-Health Interactive Message.,"Background


Since 2018, maternal mortality in Semarang City, Indonesia, has mostly (75%) occurred during the postpartum period. Therefore, a health intervention is necessary to improve safe and effective postpartum care. During the Covid-19 pandemic, a mobile-based health intervention is preferred due to the government's regulation of COVID-19 safety prevention. This study aimed to determine the effectiveness of the mobile-health interactive message on the postpartum care behavior of mothers and their husbands.
Methods


The study was conducted in a quasi-experimental design. It includes the treatment group and the control group, in which each group consists of 46 pairs of pregnant women in the third trimester and their husbands. The research subjects were chosen through the purposive sampling technique. Data collection was conducted via interviews and observations. The m-health intervention is carried out in the form of text messages, images, videos, and interactive mentoring. The latter was carried out through group messaging via the WhatsApp application for the treatment group. Meanwhile, the control group received regular counseling from the local Community Health Center. Data analysis was performed by Mann-Whitney test, unpaired T-Test, Chi-Square Test dan Fisher Exact Test.
Results


Intervention for 2.5 months increased the knowledge of mothers and husbands. The intervention for 3.5 months improved the mother's attitude, but not the husband's attitude. The intervention also improves maternal practices related to postpartum visits, such as Early Initiation of Breastfeeding assistance requests from health workers, iron tablets and nutritious food consumption, personal hygiene, postpartum danger signs monitoring, and the husband's practice of accompanying mothers during postpartum visits.
Conclusion


Mobile-Health interactive messages effectively improved postpartum care behavior for mothers and their husbands.",2022,"The intervention also improves maternal practices related to postpartum visits, such as Early Initiation of Breastfeeding assistance requests from health workers, iron tablets and nutritious food consumption, personal hygiene, postpartum danger signs monitoring, and the husband's practice of accompanying mothers during postpartum visits.
",['mothers and their husbands'],"['regular counseling from the local Community Health Center', 'mobile-health interactive message']","['knowledge of mothers and husbands', 'postpartum care behavior', ""maternal practices related to postpartum visits, such as Early Initiation of Breastfeeding assistance requests from health workers, iron tablets and nutritious food consumption, personal hygiene, postpartum danger signs monitoring, and the husband's practice of accompanying mothers during postpartum visits""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242664', 'cui_str': 'Husband'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0338050', 'cui_str': 'Local community health center'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242664', 'cui_str': 'Husband'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0453857', 'cui_str': 'Nutritious food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0564673', 'cui_str': 'Personal hygiene activities'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",,0.0278845,"The intervention also improves maternal practices related to postpartum visits, such as Early Initiation of Breastfeeding assistance requests from health workers, iron tablets and nutritious food consumption, personal hygiene, postpartum danger signs monitoring, and the husband's practice of accompanying mothers during postpartum visits.
","[{'ForeName': 'Respati', 'Initials': 'R', 'LastName': 'Wulandari', 'Affiliation': 'Doctoral Program, Faculty of Public Health, Diponegoro University, Semarang, Indonesia.'}, {'ForeName': 'Agus', 'Initials': 'A', 'LastName': 'Suwandono', 'Affiliation': 'Departement of Epidemiology, Faculty of Public Health, Diponegoro University, Semarang, Indonesia.'}, {'ForeName': 'Martha Irene', 'Initials': 'MI', 'LastName': 'Kartasurya', 'Affiliation': 'Department of Public Health Nutrition, Faculty of Public Health, Diponegoro University, Semarang, Indonesia.'}, {'ForeName': 'Sri Achadi', 'Initials': 'SA', 'LastName': 'Nugraheni', 'Affiliation': 'Department of Public Health Nutrition, Faculty of Public Health, Diponegoro University, Semarang, Indonesia.'}]",Ethiopian journal of health sciences,['10.4314/ejhs.v32i2.4']
1602,35693542,Effects of Transcranial Direct Current Stimulation Over the Left Primary Motor Cortex on Verbal Intelligence.,"Previous studies have shown that changes in gray matter density and volume in the left primary motor cortex are significantly associated with changes in individuals' verbal intelligence quotient (VIQ), but not with their performance intelligence quotient (PIQ). In the present study, we examined the effects of transcranial direct current stimulation (tDCS) over the left primary motor cortex on performance in intelligence tests. We chose four subtests (two each for VIQ and PIQ) of the Wechsler Adult Intelligence Scale-Chinese Revised version and randomized participants into anodal, cathodal, and sham groups. We found that anodal stimulation significantly improved performance in verbal intelligence subtests compared to cathodal and sham stimulation, while performance intelligence subtest scores did not change in any stimulation condition. These findings suggest that the excitation level of the left primary motor cortex has a unique effect on verbal intelligence.",2022,"We found that anodal stimulation significantly improved performance in verbal intelligence subtests compared to cathodal and sham stimulation, while performance intelligence subtest scores did not change in any stimulation condition.",[],"['anodal stimulation', 'Transcranial Direct Current Stimulation', 'transcranial direct current stimulation (tDCS']","['performance in verbal intelligence subtests', 'performance intelligence subtest scores', ""individuals' verbal intelligence quotient (VIQ"", 'Verbal Intelligence', 'verbal intelligence']",[],"[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0582577', 'cui_str': 'Verbal intelligence quotient'}]",4.0,0.0563673,"We found that anodal stimulation significantly improved performance in verbal intelligence subtests compared to cathodal and sham stimulation, while performance intelligence subtest scores did not change in any stimulation condition.","[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Psychology, Renmin University of China, Beijing, China.'}, {'ForeName': 'Yinling', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Renmin University of China, Beijing, China.'}, {'ForeName': 'Yizhe', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Psychological Counseling Center, Shanghai University, Shanghai, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Mai', 'Affiliation': 'Department of Psychology, Renmin University of China, Beijing, China.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2022.888590']
1603,35693501,Providing Support Differentially Affects Asian American and Latinx Psychosocial and Physiological Well-Being: A Pilot Study.,"Although substantial evidence suggests receiving social support has positive implications for well-being, less is known about how providing support can confer benefits, particularly for Asian American and Latinx individuals who are more likely to come from interdependent cultures that emphasize family obligation. Asian American and Latinx college students ( N  = 48;  M   age  = 21.44,  SD  = 2.61; 68.75% female) reported on anxiety before taking part in a modified laboratory task that elicited a physiological stress response as measured by total cortisol output. They were randomly assigned to write (a) a supportive note to a family member, (b) a supportive note to a close friend, or (c) about their day in a control condition after the mild lab stressor and reported on psychosocial well-being (i.e., post-task anxiety and self-esteem). Those who provided support to a family member experienced higher self-esteem compared to those in the control condition. However, there was variation in Asian American and Latinx participants' physiological stress response (i.e., total cortisol output). The findings suggest that providing support to close others, particularly family members, can be differentially meaningful for individuals from diverse backgrounds.",2022,"The findings suggest that providing support to close others, particularly family members, can be differentially meaningful for individuals from diverse backgrounds.","['Asian American and Latinx college students ( N \u2009=\u200948;  M   age \u2009=\u200921.44,  SD \u2009=\u20092.61; 68.75% female']",[],['self-esteem'],"[{'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",,0.0391023,"The findings suggest that providing support to close others, particularly family members, can be differentially meaningful for individuals from diverse backgrounds.","[{'ForeName': 'Shu-Sha Angie', 'Initials': 'SA', 'LastName': 'Guan', 'Affiliation': 'Department of Child and Adolescent Development, California State University, Northridge, CA, United States.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Jimenez', 'Affiliation': 'Department of Child and Adolescent Development, California State University, Northridge, CA, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cabrera', 'Affiliation': 'Department of Child and Adolescent Development, California State University, Northridge, CA, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cho', 'Affiliation': 'Department of Child and Adolescent Development, California State University, Northridge, CA, United States.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ullah', 'Affiliation': 'Department of Environmental and Occupational Health, California State University, Northridge, CA, United States.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Den Broeder', 'Affiliation': 'Department of Health Sciences, California State University, Northridge, CA, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2022.869715']
1604,35693457,Effect of Sectioning of the Anterior Cruciate Ligament and Posterolateral Structures on Lateral Compartment Gapping: A Randomized Biomechanical Study.,"Background


The contribution of anterior cruciate ligament (ACL) injury to lateral instability under varus stress, particularly compared with posterolateral structures, is not well known.
Purpose


To investigate the effect of sectioning the ACL and posterolateral knee structures on lateral compartment gapping under varus stress.
Study Design


Controlled laboratory study.
Methods


Fourteen nonpaired cadaveric knees were randomized to 1 of 2 groups: sequential sectioning of the ACL, fibular collateral ligament (FCL), popliteus tendon (PLT), and popliteofibular ligament (PFL) (ACL-first group) or sequential sectioning of the FCL, PLT, PFL, and ACL (FCL-first group). Knees were loaded onto a custom jig at a 20° flexion angle. A standardized 12-N·m varus moment was applied to each specimen in the intact state and after each randomized sequential-sectioning state. Lateral compartment opening was measured on radiographs to assess the contribution to the increase in the lateral gap caused by resecting the respective structure. The distance was measured by 3 observers on 15 images (5 testing states each imaged 3 times) per specimen, for a total of 210 radiographs. The articular cartilage surfaces were not included in the measurements.
Results


The mean increase in lateral opening after sectioning all structures (ACL and posterolateral corner) was 4.6 ± 1.8 mm (range, 1.9-7.7 mm). The ACL and FCL sectioning contributed the most to lateral knee opening (1.3 ± 0.6 and 2.2 ± 1.3 mm, respectively). In both groups, lateral gapping >3 mm was achieved only after both the ACL and FCL were sectioned. All comparisons of increased mean gapping distances demonstrated a significant difference with subsequent sequential sectioning of structures, except comparisons between the FCL and PLT and the PLT and PFL. When considering the effect of the ACL on lateral opening, no significant difference was found between sectioning the ACL first or FCL first ( P  = .387).
Conclusion


ACL deficiency significantly increased lateral opening under varus stress, regardless of the sequence of injury. The effect of injury to the ACL in addition to the lateral structures should be considered when using varus stress radiographs to evaluate knee injuries.
Clinical Relevance


With the current findings, understanding the effect of ACL and posterolateral corner injuries on lateral gapping under varus stress can aid in correctly diagnosing knee injuries and determining appropriate treatment plans.",2022,"The ACL and FCL sectioning contributed the most to lateral knee opening (1.3 ± 0.6 and 2.2 ± 1.3 mm, respectively).",['Methods\n\n\nFourteen nonpaired cadaveric knees'],"['ACL', 'Sectioning of the Anterior Cruciate Ligament and Posterolateral Structures', 'sequential sectioning of the ACL, fibular collateral ligament (FCL), popliteus tendon (PLT), and popliteofibular ligament (PFL) (ACL-first group) or sequential sectioning of the FCL, PLT, PFL, and ACL (FCL-first group']","['lateral opening under varus stress', 'mean increase in lateral opening', 'articular cartilage surfaces']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0206365', 'cui_str': 'Structure of collateral ligament'}, {'cui': 'C0448645', 'cui_str': 'Tendon of popliteus'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007303', 'cui_str': 'Structure of articular cartilage'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",210.0,0.0550007,"The ACL and FCL sectioning contributed the most to lateral knee opening (1.3 ± 0.6 and 2.2 ± 1.3 mm, respectively).","[{'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Gursoy', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'Perry', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Navya', 'Initials': 'N', 'LastName': 'Dandu', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Harsh', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Amar S', 'Initials': 'AS', 'LastName': 'Vadhera', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Yanke', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'LaPrade', 'Affiliation': 'Twin Cities Orthopedics, Edina, Minnesota, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Chahla', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, USA.'}]",Orthopaedic journal of sports medicine,['10.1177/23259671221100216']
1605,35693746,"Comparison of the effects of dexmedetomidine and propofol on hypothermia in patients under spinal anesthesia: a prospective, randomized, and controlled trial.","Background:  Redistribution hypothermia caused by vasodilation during anesthesia is the primary cause of perioperative hypothermia. Propofol exerts a dose-dependent vasodilatory effect, whereas dexmedetomidine induces peripheral vasoconstriction at high plasma concentrations. This study compared the effects of dexmedetomidine and propofol on core temperature in patients undergoing surgery under spinal anesthesia.  Methods:  This prospective study included 40 patients (aged 19-70 years) with American Society of Anesthesiologists Physical Status class I-III who underwent elective orthopedic lower-limb surgery under spinal anesthesia. Patients were randomly allocated to a dexmedetomidine or propofol group ( n  = 20 per group). After induction of spinal anesthesia, patients received dexmedetomidine (loading dose: 1 μg/kg over 10 min; maintenance dose: 0.2-0.7 μg/kg/h) or propofol (loading dose: 75 μg/kg over 10 min; maintenance dose: 12.5-75 μg/kg/min). The doses of sedatives were titrated to maintain moderate sedation. During the perioperative period, tympanic temperatures, thermal comfort score, and shivering grade were recorded.  Results:  Core temperature at the end of surgery did not differ significantly between the groups (36.4 ± 0.4 and 36.1 ± 0.7°C in the dexmedetomidine and propofol groups, respectively; P = 0.118). The lowest perioperative temperature, incidence and severity of perioperative hypothermia, thermal comfort score, and shivering grade did not differ significantly between the groups (all P > 0.05).  Conclusions:  In patients undergoing spinal anesthesia with moderate sedation, the effect of dexmedetomidine on patients' core temperature was similar to that of propofol.",2022,"The lowest perioperative temperature, incidence and severity of perioperative hypothermia, thermal comfort score, and shivering grade did not differ significantly between the groups (all P > 0.05).  ","['patients under spinal anesthesia', 'patients undergoing surgery under spinal anesthesia', '40 patients (aged 19-70 years) with American Society of Anesthesiologists Physical Status class I-III who underwent elective orthopedic lower-limb surgery under spinal anesthesia', 'patients undergoing spinal anesthesia with moderate sedation']","['dexmedetomidine and propofol', 'propofol', 'dexmedetomidine or propofol', 'Propofol', 'propofol (loading dose', 'dexmedetomidine']","['hypothermia', 'tympanic temperatures, thermal comfort score, and shivering grade', 'lowest perioperative temperature, incidence and severity of perioperative hypothermia, thermal comfort score, and shivering grade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0578808', 'cui_str': 'American Society of Anesthesiologists physical status class'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",40.0,0.0329025,"The lowest perioperative temperature, incidence and severity of perioperative hypothermia, thermal comfort score, and shivering grade did not differ significantly between the groups (all P > 0.05).  ","[{'ForeName': 'Minhye', 'Initials': 'M', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Sung-Ae', 'Initials': 'SA', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Seok-Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Tae-Yun', 'Initials': 'TY', 'LastName': 'Sung', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Choon-Kyu', 'Initials': 'CK', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Young Seok', 'Initials': 'YS', 'LastName': 'Jee', 'Affiliation': 'Department of Anesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea.'}]",International journal of medical sciences,['10.7150/ijms.72754']
1606,35694108,Examining differential responses to the  Take Care of Me  trial: A latent class and moderation analysis.,"Given prevalent alcohol misuse-emotional comorbidities among young adults, we developed an internet-based integrated treatment called  Take Care of Me . Although the treatment had an impact on several secondary outcomes, effects were not observed for the primary outcome. Therefore, the goal of the current study was to examine heterogeneity in treatment responses. The initial RCT randomized participants to either a treatment or psychoeducational control condition. We conducted an exploratory latent class analysis to distinguish individuals based on pre-treatment risk and then used moderated regressions to examine differential treatment responses based on class membership. We found evidence for three distinct groups. Most participants fell in the ""low severity"" group (n = 123), followed by the ""moderate severity"" group (n = 57) who had a higher likelihood of endorsing a previous mental health diagnosis and treatment and higher symptom severity than the low group. The ""high severity"" group (n = 42) endorsed a family history of alcoholism, and the highest symptom severity and executive dysfunction. Moderated regressions revealed significant class differences in treatment responses. In the treatment condition, high severity (relative to low) participants reported higher alcohol consumption and hazardous drinking and lower quality of life at follow-up, whereas moderate severity (relative to low) individuals had lower alcohol consumption at follow-up, and lower hazardous drinking at end-of-treatment. No class differences were found for participants in the control group. Higher risk individuals in the treatment condition had poorer responses to the program. Tailoring interventions to severity may be important to examine in future research.",2022,"In the treatment condition, high severity (relative to low) participants reported higher alcohol consumption and hazardous drinking and lower quality of life at follow-up, whereas moderate severity (relative to low) individuals had lower alcohol consumption at follow-up, and lower hazardous drinking at end-of-treatment.",['young adults'],['psychoeducational control condition'],"['alcohol consumption', 'alcohol consumption and hazardous drinking and lower quality of life']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0226137,"In the treatment condition, high severity (relative to low) participants reported higher alcohol consumption and hazardous drinking and lower quality of life at follow-up, whereas moderate severity (relative to low) individuals had lower alcohol consumption at follow-up, and lower hazardous drinking at end-of-treatment.","[{'ForeName': 'Jona R', 'Initials': 'JR', 'LastName': 'Frohlich', 'Affiliation': 'Department of Psychology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Karli K', 'Initials': 'KK', 'LastName': 'Rapinda', 'Affiliation': 'Department of Psychology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wenger', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Arkin Mental Health Care, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of eMental Health, University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Hadjistavropoulos', 'Affiliation': 'University of Regina, Psychology, Regina, SK, Canada.'}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Mackenzie', 'Affiliation': 'Department of Psychology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Wardell', 'Affiliation': 'Department of Psychology, York University, Toronto, ON, Canada.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Edgerton', 'Affiliation': 'Department of Sociology and Criminology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Keough', 'Affiliation': 'Department of Psychology, York University, Toronto, ON, Canada.'}]",Addictive behaviors reports,['10.1016/j.abrep.2022.100437']
1607,35694107,Research on the Effect of MT+FES Training on Sensorimotor Cortex.,"Purpose


Aiming at the motor recovery of patients with unilateral upper limb motor dysfunction after stroke, we propose a mirror therapy (MT) training method, which uses surface electromyography (sEMG) to identify movements on one side and control the other side to perform functional electrical stimulation (FES) while mirror therapy is used. And we verify the effect of this training method by analyzing the activity changes of the sensorimotor cortex.
Method


Ten subjects (6 men and 4 women) were randomly divided into two groups according to 3 men and 2 women in each group: the experimental group ( n  = 5) received FES+MT training, and the control group ( n  = 5) received MT training. Both groups were trained at a fixed time at 9 : 00 am every day, each time lasting 20 minutes, once a day, 5 days a week, continuous training for 4 weeks, and the training action was elbow flexion training. During the training of the elbow flexion exercise, the experimental group applied FES with a frequency of 30 Hz, a pulse width of 100  μs , and a current of 10 mA to the muscles corresponding to the elbow flexion exercise, and rested for 10 s after 10-s stimulation. We collect the EEG of the elbow flexion motor imagery of all subjects before and after training, and calculate the eigenvalue  E , and analyze the effect of FES+MT training on the activity of the cerebral sensorimotor cortex.
Results


After repeated measure (RM) two-way ANOVA of the two groups, comparing the subjects'  μ  rhythm elbow flexion motor imagery eigenvalue E, the experimental group (after training) > the control group (after training) > before training.
Conclusion


The FES+MT training method has obvious activation effect on the cerebral sensorimotor cortex.",2022,The FES+MT training method has obvious activation effect on the cerebral sensorimotor cortex.,"['Ten subjects (6 men and 4 women', 'patients with unilateral upper limb motor dysfunction after stroke']","['mirror therapy (MT) training method, which uses surface electromyography (sEMG) to identify movements on one side and control the other side to perform functional electrical stimulation (FES) while mirror therapy', 'FES+MT training', 'MT+FES Training', 'MT training']",['Sensorimotor Cortex'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}]","[{'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}]",,0.00146142,The FES+MT training method has obvious activation effect on the cerebral sensorimotor cortex.,"[{'ForeName': 'Yuan-Xing', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Institute of Intelligent Control and Robotics, Hangzhou Dianzi University, Hangzhou 310018, China.'}, {'ForeName': 'Zhi-Zeng', 'Initials': 'ZZ', 'LastName': 'Luo', 'Affiliation': 'Institute of Intelligent Control and Robotics, Hangzhou Dianzi University, Hangzhou 310018, China.'}]",Neural plasticity,['10.1155/2022/6385755']
1608,35694079,"Comparison of Recovery Profiles of Patients Undergoing Endoscopic Lumbar Discectomy under Desflurane, Propofol, or Sevoflurane Anesthesia: A Randomized, Prospective, Clinical, Comparative Study.","Background   Agents like propofol, sevoflurane, and desflurane having rapid revival of psychomotor and cognitive functions translating into reliable anesthetic recovery are chosen for day care procedures. This prospective randomized comparative study was undertaken to compare the psychomotor and cognitive functions of patients undergoing discectomy under different anesthetic strategies.  Methods   Seventy-five adult American Society of Anesthesiologists grade I and II patients being operated for endoscopic lumbar discectomy under different anesthetic regimens were enrolled and were subjected to Trieger Dot Test (TDT), Digit Symbol Substitution Test (DSST), and Mini-Mental State Examination (MMSE) preoperatively at specified intervals postoperatively. There emergence and early recovery times, complications, and satisfaction levels were also noted.  Results   No difference was found in the postoperative TDT and DSST and MMSE scores among the groups at all the time points (15 minutes, 3 minutes, 1 hour, 2 hours, 3 hours, and 4 hours). TDT and DSST demonstrated a tendency to return to baseline by 2nd and 3rd hour postoperatively. Emergence and early recovery times were earlier in the inhalation groups (  p  0.005 and 0.007, respectively). Time required to attain a Modified Aldrete Score of 9, complications, and observed side effects were similar among the groups.  Conclusion   Patients in the three groups had similar impairments in their psychomotor and cognitive functions which recovered at comparable time periods postoperatively. Emergence and early recovery were, however, faster in the desflurane group.",2022,"No difference was found in the postoperative TDT and DSST and MMSE scores among the groups at all the time points (15 minutes, 3 minutes, 1 hour, 2 hours, 3 hours, and 4 hours).","['I and II patients being operated for endoscopic lumbar discectomy under different anesthetic regimens', 'adult American Society of Anesthesiologists grade', 'patients undergoing discectomy under different anesthetic strategies', 'Patients Undergoing Endoscopic Lumbar Discectomy under', 'Methods  \u2003Seventy-five']","['TDT and DSST', 'desflurane', 'propofol, sevoflurane, and desflurane', 'Desflurane, Propofol, or Sevoflurane Anesthesia']","['postoperative TDT and DSST and MMSE scores', 'Time required to attain a Modified Aldrete Score of 9, complications, and observed side effects', 'psychomotor and cognitive functions', 'Emergence and early recovery times', 'Trieger Dot Test (TDT), Digit Symbol Substitution Test (DSST), and Mini-Mental State Examination (MMSE', 'emergence and early recovery times, complications, and satisfaction levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",75.0,0.0364036,"No difference was found in the postoperative TDT and DSST and MMSE scores among the groups at all the time points (15 minutes, 3 minutes, 1 hour, 2 hours, 3 hours, and 4 hours).","[{'ForeName': 'Amit Kumar', 'Initials': 'AK', 'LastName': 'Verma', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Rudrashish', 'Initials': 'R', 'LastName': 'Haldar', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Shashi', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Kuntal Kanti', 'Initials': 'KK', 'LastName': 'Das', 'Affiliation': 'Department of Neurosurgery, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Prabhaker', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Department of Biostatistics, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}]",Journal of neurosciences in rural practice,['10.1055/s-0042-1743443']
1609,35694071,"Commentary on ""Comparison of Recovery Profiles of Patients Undergoing Endoscopic Lumbar Discectomy under Desflurane, Propofol, or Sevoflurane Anesthesia. A Randomized, Prospective, Clinical, Comparative Study"".",,2022,,['Patients Undergoing Endoscopic Lumbar Discectomy under'],"['Desflurane, Propofol, or Sevoflurane Anesthesia']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",[],,0.0151424,,"[{'ForeName': 'Sohan Lal', 'Initials': 'SL', 'LastName': 'Solanki', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Ketan', 'Initials': 'K', 'LastName': 'Kataria', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}]",Journal of neurosciences in rural practice,['10.1055/s-0042-1744121']
1610,35693874,Efficacy of single-dose HPV vaccination among young African women.,"Background


Single-dose HPV vaccination, if efficacious, would be tremendously advantageous; simplifying implementation and decreasing costs.
Methods


We performed a randomized, multi-center, double-blind, controlled trial of single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11) or bivalent (HPV 16/18) HPV vaccination compared to meningococcal vaccination among Kenyan women aged 15-20 years. Enrollment and six monthly cervical swabs and a month three vaginal swab were tested for HPV DNA. Enrollment sera were tested for HPV antibodies. The modified intent-to-treat (mITT) cohort comprised participants who tested HPV antibody negative at enrollment and HPV DNA negative at enrollment and month three. The primary outcome was incident persistent vaccine-type HPV infection by month 18.
Results


Between December 2018 and June 2021, 2,275 women were randomly assigned and followed; 758 received the nonavalent HPV vaccine, 760 the bivalent HPV vaccine, and 757 the meningococcal vaccine; retention was 98%. Thirty-eight incident persistent infections were detected in the HPV 16/18 mITT cohort: one each among participants assigned to the bivalent and nonavalent groups and 36 among those assigned to the meningococcal group; nonavalent Vaccine Efficacy (VE) was 97.5% (95%CI 81.7-99.7%, p=<0.0001), and bivalent VE was 97.5% (95%CI 81.6-99.7%, p=<0.0001). Thirty-three incident persistent infections were detected in the HPV 16/18/31/33/45/52/58 mITT cohort: four in the nonavalent group and 29 in the meningococcal group; nonavalent VE for HPV 16/18/31/33/45/52/58 was 88.9% (95%CI 68.5-96.1%, p<0.0001). The rate of SAEs was 4.5-5.2% by group.
Conclusions


Over the 18 month time-frame we studied, single-dose bivalent and nonavalent HPV vaccines were each highly effective in preventing incident persistent oncogenic HPV infection, similar to multidose regimens.",2022,"; nonavalent Vaccine Efficacy (VE) was 97.5% (95%CI 81.7-99.7%, p=<0.0001), and bivalent VE was 97.5% (95%CI 81.6-99.7%, p=<0.0001).","['2,275 women were randomly assigned and followed; 758 received the', 'Results\n\n\nBetween December 2018 and June 2021', 'Kenyan women aged 15-20 years', 'young African women']","['nonavalent HPV vaccine, 760 the bivalent HPV vaccine', 'single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11) or bivalent (HPV 16/18) HPV vaccination', 'single-dose HPV vaccination', 'meningococcal group']","['rate of SAEs', 'Vaccine Efficacy (VE', 'incident persistent vaccine-type HPV infection', 'bivalent VE']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027567', 'cui_str': 'African race'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}]",2275.0,0.414272,"; nonavalent Vaccine Efficacy (VE) was 97.5% (95%CI 81.7-99.7%, p=<0.0001), and bivalent VE was 97.5% (95%CI 81.6-99.7%, p=<0.0001).","[{'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, USA.'}, {'ForeName': 'Maricianah A', 'Initials': 'MA', 'LastName': 'Onono', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, Kenya.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Njoroge', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Kenya.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Winer', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, USA.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Galloway', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'Leeya F', 'Initials': 'LF', 'LastName': 'Pinder', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Wakhungu', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, Kenya.'}, {'ForeName': 'Ouma', 'Initials': 'O', 'LastName': 'Congo', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Kenya.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Biwott', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Kenya.'}, {'ForeName': 'Syovata', 'Initials': 'S', 'LastName': 'Kimanthi', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Kenya.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Oluoch', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Kenya.'}, {'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Heller', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Leingang', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morrison', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Rechkina', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cherne', 'Affiliation': 'Department of Pathology, University of Washington, Seattle, USA.'}, {'ForeName': 'Torin T', 'Initials': 'TT', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'McClelland', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mugo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}]",NEJM evidence,['10.1056/EVIDoa2100056']
1611,35694182,Development and Pilot Randomized Trial of a Coping Skills Intervention for Low-SES Latinx Families of Children with Asthma.,"Objective


Psychosocial stress contributes to asthma disparities for low-SES Latinx children, but primary and secondary control coping by children and parents is associated with better psychosocial and asthma outcomes. Therefore, we developed and pilot tested  Adapt 2 Asthma  (A2A), a family-based coping and asthma self-management intervention for low-SES Latinx families.
Methods


Children, parents, and primary care providers (N=16) participated in five focus groups to refine A2A's content and delivery. Subsequently, families of children ages 9-12 with asthma (N=24) were recruited from primary care clinics and randomly assigned to receive A2A or enhanced usual care (EUC).
Results


Based on focus groups, A2A was refined to address feasibility, Latinx-specific cultural factors, and provider-family gaps. Results of the pilot RCT showed that 92% of families completed all sessions of A2A, and there were high levels of satisfaction with and fidelity to A2A. There were no statistically significant differences between the A2A and EUC groups at 3-month follow-up, although there were small, non-significant effects favoring A2A on parent-reported asthma control, parent secondary control coping, and emergency department visits.
Conclusions


We found evidence of acceptability, feasibility, and potential benefits of A2A for low-SES Latinx families. Findings provide guidance for future implementation in primary care.",2022,"There were no statistically significant differences between the A2A and EUC groups at 3-month follow-up, although there were small, non-significant effects favoring A2A on parent-reported asthma control, parent secondary control coping, and emergency department visits.
","[""Methods\n\n\nChildren, parents, and primary care providers (N=16) participated in five focus groups to refine A2A's content and delivery"", 'Low-SES Latinx Families of Children with Asthma', 'Subsequently, families of children ages 9-12 with asthma (N=24) were recruited from primary care clinics']","['A2A or enhanced usual care (EUC', 'Coping Skills Intervention']",['satisfaction with and fidelity to A2A'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0628114,"There were no statistically significant differences between the A2A and EUC groups at 3-month follow-up, although there were small, non-significant effects favoring A2A on parent-reported asthma control, parent secondary control coping, and emergency department visits.
","[{'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, 1912 Speedway, Stop D5000, Austin, TX 78712.'}, {'ForeName': 'Sharon D', 'Initials': 'SD', 'LastName': 'Horner', 'Affiliation': 'School of Nursing, University of Texas at Austin, 1710 Red River Street, Austin, TX 78712.'}, {'ForeName': 'Sarah Kate', 'Initials': 'SK', 'LastName': 'Bearman', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, 1912 Speedway, Stop D5000, Austin, TX 78712.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Gulbas', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, 1925 San Jacinto Blvd D3500, Austin, TX 78712.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'George-Jones', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, 1912 Speedway, Stop D5000, Austin, TX 78712.'}, {'ForeName': 'Cinthia', 'Initials': 'C', 'LastName': 'Alvarado', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, 1912 Speedway, Stop D5000, Austin, TX 78712.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Esperanza', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, 1912 Speedway, Stop D5000, Austin, TX 78712.'}]",Clinical practice in pediatric psychology,['10.1037/cpp0000423']
1612,35694173,Bitter Orange  (Citrus aurantium L.)  Intake Before Submaximal Aerobic Exercise Is Safe for Cardiovascular and Autonomic Systems in Healthy Males: A Randomized Trial.,"Background


There are still no studies of the cardiovascular safety of the isolated use of  Citrus aurantium  in aerobic submaximal exercise.
Objective


To evaluate the effect of  C. aurantium  supplementation on the recovery of cardiorespiratory and autonomic parameters following a session of submaximal aerobic exercise.
Methods


Twelve healthy male adults achieved a crossover, randomized, double-blind, and placebo-controlled trial.  C. aurantium  (600 mg, p-synephrine at 30% amount [180 mg]) or placebo (600 mg of starch) were ingested 90 min before evaluation in randomized days. We evaluated systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP), mean arterial pressure (MAP), heart rate (HR) and, HR variability indexes at Rest and during 60 min of recovery from exercise.
Results


Citrus aurantium  ingestion accelerated the reduction in SBP after exercise, anticipated the return of vagal modulation of the heart after exercise via the HF (ms2), pNN50 (%), and 2 UV% indices. Moreover, rushed the output of sympathetic modulation after exercise via the 0V% index. No unfavorable cardiovascular effects were achieved for HR, DBP, PP, and MAP parameters.
Conclusions


Citrus aurantium  was shown to be safe for the cardiovascular and autonomic systems alongside submaximal aerobic exercise in healthy males.",2022,"Conclusions


Citrus aurantium  was shown to be safe for the cardiovascular and autonomic systems alongside submaximal aerobic exercise in healthy males.","['Twelve healthy male adults', 'Healthy Males', 'healthy males']","['C. aurantium  supplementation', 'Bitter Orange  (Citrus aurantium L.)  Intake', 'C. aurantium  ', 'Submaximal Aerobic Exercise', 'placebo']","['SBP', 'return of vagal modulation', 'recovery of cardiorespiratory and autonomic parameters', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP), mean arterial pressure (MAP), heart rate (HR) and, HR variability indexes at Rest and during 60 min of recovery from exercise', 'HR, DBP, PP, and MAP parameters', 'unfavorable cardiovascular effects']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0330922', 'cui_str': 'Citrus aurantium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",12.0,0.0925639,"Conclusions


Citrus aurantium  was shown to be safe for the cardiovascular and autonomic systems alongside submaximal aerobic exercise in healthy males.","[{'ForeName': 'Cicero Jonas R', 'Initials': 'CJR', 'LastName': 'Benjamim', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Francisco Welington de Sousa', 'Initials': 'FWS', 'LastName': 'Júnior', 'Affiliation': 'University Center of the Juazeiro do Norte, Juazeiro do Norte, Brazil.'}, {'ForeName': 'Andrey Alves', 'Initials': 'AA', 'LastName': 'Porto', 'Affiliation': 'Autonomic Nervous System Center, São Paulo State University (UNESP), Marilia, São Paulo, Brazil.'}, {'ForeName': 'Élida Mara B', 'Initials': 'ÉMB', 'LastName': 'Rocha', 'Affiliation': 'University Center of the Juazeiro do Norte, Juazeiro do Norte, Brazil.'}, {'ForeName': 'Milana D', 'Initials': 'MD', 'LastName': 'Santana', 'Affiliation': 'University Center of the Juazeiro do Norte, Juazeiro do Norte, Brazil.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Garner', 'Affiliation': 'Autonomic Nervous System Center, São Paulo State University (UNESP), Marilia, São Paulo, Brazil.'}, {'ForeName': 'Vitor E', 'Initials': 'VE', 'LastName': 'Valenti', 'Affiliation': 'Autonomic Nervous System Center, São Paulo State University (UNESP), Marilia, São Paulo, Brazil.'}, {'ForeName': 'Carlos Roberto', 'Initials': 'CR', 'LastName': 'Bueno Júnior', 'Affiliation': 'Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}]",Frontiers in nutrition,['10.3389/fnut.2022.890388']
1613,35694163,"Impact of Intermittent Fasting Combined With High-Intensity Interval Training on Body Composition, Metabolic Biomarkers, and Physical Fitness in Women With Obesity.","Background


Intermittent fasting (IF) is a dietary approach that is widely popular due to its effects on weight and body fat loss, but it does not appear to ensure muscle mass preservation. Incorporating high-intensity interval training (HIIT) into an individual's routine could be an attractive and viable therapeutic option for improving body composition, lifestyle and health promotion. Problematizing the emerging situation of fighting obesity, led us to clarify gaps about IF and hypothesize that IF and HIIT in conjunction may protect against muscle mass decline without impairing nitrogen balance (NB), in addition to improving the physical fitness of women with obesity.
Objectives


To evaluate the effects of IF alone and combined with HIIT on body composition, NB and strength and physical fitness in women with obesity.
Methods


Thirty-six women (BMI 34.0 ± 3.2; 32.2 ± 4.4 years) participated and were randomly distributed into three groups: (1) Intermittent fasting combined with exercise group (IF + EX); (2) Exercise group (EX); and (3) Intermittent fasting group (IF). The interventions took place over 8 weeks and all evaluations were performed pre and post-intervention. The HIIT circuit was performed 3x/week, for 25 mins/session, at 70-85% of the maximum heart rate. The intermittent fasting protocol was a 5:2 diet with two meals within 6 h on fasting days, being 25% of total energy intake, plus 18 h of complete fasting. The protocol was performed 2x/week and 5 days of  ad libitum  ingestion. Resting metabolic rate (RMR) was measured by indirect calorimetry, body composition by BodPod ® , NB from urinary nitrogen, food consumption by food records and physical and strength performance were measured by physical tests. ANOVA two-way repeated measures mixed model was performed followed by Sidak  post hoc  ( p  < 0.05). This project was registered in ClinicalTrials.gov, NCT05237154.
Results


There were a reduction in body weight ( P  = 0.012) and BMI ( P  = 0.031) only in the IF + EX group. There was body fat loss in the IF + EX group (-4%,  P  < 0.001) and in the EX group (-2.3%,  P  = 0.043), an increase in fat-free mass in the IF + EX group (+3.3%,  P  < 0.001) and also in the EX group (+2%,  P  = 0.043), without differences between groups and the IF group showed no changes. The NB was equilibrium in all groups. All parameters of aerobic capacity and strength improved.
Conclusion


Combining IF with HIIT can promote increments in fat-free mass, NB equilibrium and improve physical fitness and strength.",2022,"There was body fat loss in the IF + EX group (-4%,  P  < 0.001) and in the EX group (-2.3%,  P  = 0.043), an increase in fat-free mass in the IF + EX group (+3.3%,  P  < 0.001) and also in the EX group (+2%,  P  = 0.043), without differences between groups and the IF group showed no changes.","['women with obesity', 'Women With Obesity', 'Methods\n\n\nThirty-six women (BMI 34.0 ± 3.2; 32.2 ± 4.4 years) participated and were randomly distributed into three groups']","['Incorporating high-intensity interval training (HIIT', 'IF alone and combined with HIIT', 'High-Intensity Interval Training', 'Intermittent fasting combined with exercise group (IF + EX); (2) Exercise group (EX); and (3) Intermittent fasting group (IF']","['Resting metabolic rate (RMR', 'BMI', 'body composition, NB and strength and physical fitness', 'fat-free mass', 'fat-free mass, NB equilibrium and improve physical fitness and strength', 'body fat loss', 'indirect calorimetry, body composition by BodPod ® , NB from urinary nitrogen, food consumption by food records and physical and strength performance', 'aerobic capacity and strength improved', 'body weight', 'Body Composition, Metabolic Biomarkers, and Physical Fitness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0429631', 'cui_str': 'Nitrogen balance'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424630', 'cui_str': 'Loss of body fat - finding'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",36.0,0.00563122,"There was body fat loss in the IF + EX group (-4%,  P  < 0.001) and in the EX group (-2.3%,  P  = 0.043), an increase in fat-free mass in the IF + EX group (+3.3%,  P  < 0.001) and also in the EX group (+2%,  P  = 0.043), without differences between groups and the IF group showed no changes.","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Batitucci', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of São Paulo - FCFAR/UNESP, Araraquara, Brazil.'}, {'ForeName': 'Eli V', 'Initials': 'EV', 'LastName': 'Faria Junior', 'Affiliation': 'Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo - FMRP/USP, Ribeirão Preto, Brazil.'}, {'ForeName': 'Jonatas E', 'Initials': 'JE', 'LastName': 'Nogueira', 'Affiliation': 'Laboratory of Exercise Physiology and Metabolism, School of Physical Education and Sports of Ribeirão Preto, University of São Paulo - EEFERP/USP, Ribeirão Preto, Brazil.'}, {'ForeName': 'Camila F C', 'Initials': 'CFC', 'LastName': 'Brandão', 'Affiliation': 'Internal Medicine Department, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Gabriela F', 'Initials': 'GF', 'LastName': 'Abud', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of São Paulo - FCFAR/UNESP, Araraquara, Brazil.'}, {'ForeName': 'Gabriela U', 'Initials': 'GU', 'LastName': 'Ortiz', 'Affiliation': 'Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo - FMRP/USP, Ribeirão Preto, Brazil.'}, {'ForeName': 'Julio S', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Internal Medicine Department, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Ellen C', 'Initials': 'EC', 'LastName': 'Freitas', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of São Paulo - FCFAR/UNESP, Araraquara, Brazil.'}]",Frontiers in nutrition,['10.3389/fnut.2022.884305']
1614,35694161,"Extruded Wheat Bran Consumption Increases Serum Short-Chain Fatty Acids but Does Not Modulate Psychobiological Functions in Healthy Men: A Randomized, Placebo-Controlled Trial.","Background


Incorporation of wheat bran (WB) into food products increases intake of dietary fiber, which has been associated with improved mood and cognition and a lower risk for psychiatric disorders such as depression, with short-chain fatty acids (SCFAs) as candidate mediators of these effects. Modifying WB using extrusion cooking increases SCFA production  in vitro  relative to unmodified WB.
Objective


The aim of this study was to evaluate the effects of extruded WB on psychobiological functioning and the mediating role of SCFAs.
Methods


In a randomized, triple-blind, placebo-controlled trial, 69 healthy male participants consumed 55 g of breakfast cereal containing either extruded WB or placebo daily for 28 days. At pre- and post-intervention visits, the cortisol response to experimentally induced stress was measured as a primary outcome. In addition, serum SCFAs and brain-derived neurotrophic factors were quantified as potential mediators. Secondary psychobiological outcomes included subjective stress responses, responses to experimentally induced fear, cortisol awakening response, heart rate variability, and retrospective subjective mood ratings. Intestinal permeability, fecal SCFAs, and stool consistency were measured as secondary biological outcomes.
Results


Extruded WB increased serum acetate and butyrate ( p  < 0.05). None of the primary or secondary outcomes were affected by the intervention. Participants who consumed a placebo exhibited an increase in the percentage of fecal dry weight but did not report increased constipation. Despite these statistically significant effects, these changes were small in magnitude.
Conclusions


Extruded WB consumption increased serum short-chain fatty acids but did not modulate psychobiological functions in healthy men. Effective modulation of psychobiological functions may require greater increases in SCFAs than those achieved following extruded WB consumption. Rather than attempting to induce health benefits with a single fiber-rich food, combinations of different fibers, particularly highly fermentable ones, might be needed to further increase SCFA production and uptake in the systemic circulation to observe an effect on psychobiological processes.",2022,Extruded WB increased serum acetate and butyrate ( p  < 0.05).,"['Healthy Men', '69 healthy male participants consumed 55 g of', 'healthy men']","['wheat bran (WB', 'extruded WB', 'breakfast cereal containing either extruded WB or placebo', 'Extruded Wheat Bran Consumption', 'placebo', 'Placebo']","['percentage of fecal dry weight', 'constipation', 'serum SCFAs and brain-derived neurotrophic factors', 'Serum Short-Chain Fatty Acids', 'Intestinal permeability, fecal SCFAs, and stool consistency', 'serum acetate and butyrate', 'subjective stress responses, responses to experimentally induced fear, cortisol awakening response, heart rate variability, and retrospective subjective mood ratings', 'SCFAs', 'psychobiological functions']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0043138', 'cui_str': 'Wheat bran'}, {'cui': 'C0532245', 'cui_str': 'Extrude'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",69.0,0.158827,Extruded WB increased serum acetate and butyrate ( p  < 0.05).,"[{'ForeName': 'Boushra', 'Initials': 'B', 'LastName': 'Dalile', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases and Metabolism, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Danique', 'Initials': 'D', 'LastName': 'La Torre', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases and Metabolism, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Polona', 'Initials': 'P', 'LastName': 'Kalc', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases and Metabolism, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zoppas', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases and Metabolism, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Roye', 'Affiliation': 'Laboratory of Food Chemistry and Biochemistry and Leuven Food Science and Nutrition Research Centre (LFoRCe), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Chrystel', 'Initials': 'C', 'LastName': 'Loret', 'Affiliation': 'Nestlé Product Technology Centre, Coffee Société des Produits Nestlé S.A., Lausanne, Switzerland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lamothe', 'Affiliation': 'Nestlé Institute of Materials Science, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Bergonzelli', 'Affiliation': 'Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.'}, {'ForeName': 'Christophe M', 'Initials': 'CM', 'LastName': 'Courtin', 'Affiliation': 'Laboratory of Food Chemistry and Biochemistry and Leuven Food Science and Nutrition Research Centre (LFoRCe), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Leuven Brain Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lukas Van', 'Initials': 'LV', 'LastName': 'Oudenhove', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases and Metabolism, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Verbeke', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases and Metabolism, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}]",Frontiers in nutrition,['10.3389/fnut.2022.896154']
1615,35694159,"The Risk Reduction Effect of a Nutritional Intervention With a Partially Hydrolyzed Whey-Based Formula on Cow's Milk Protein Allergy and Atopic Dermatitis in High-Risk Infants Within the First 6 Months of Life: The Allergy Reduction Trial (A.R.T.), a Multicenter Double-Blinded Randomized Controlled Study.","Background


The role of partially hydrolyzed formulas (pHF) as part of nutritional interventions to prevent the development of allergic manifestations (AM) is questioned, and efficacy of each specific pHF should be substantiated.
Objective


To investigate the risk-reduction effect of a whey-based pHF on the development of cow's milk protein allergy (CMPA) and atopic dermatitis (AD) in infants at high-risk for allergy within the first 6 months of life.
Materials and Methods


In a multicenter double-blinded randomized controlled setting, healthy non-exclusively breastfed full-term infants, received either a specific whey-based pHF or a standard cow's milk-based formula (SF) and were clinically assessed for AM at 2, 4, and 6 months of age, supported by the objective scoring tools SCORAD and CoMiSS. CMPA was confirmed by open food challenge. Intention-to-Treat (ITT) and Per-Protocol (PP) analyses were performed.
Results


Of 331 randomized subjects (ITT analysis set), 160 received the pHF and 171 the SF. Six (3.8%) infants in the pHF and 12 (7%) in the SF group developed CMPA ( p  = 0.186). AD incidence was significantly lower in those receiving pHF as compared to SF (10.6% vs. 18.7%,  p  = 0.024) with a relative risk (RR, 95% CI) of 0.54 (0.32, 0.92), in particular when adjusting for family history of AD [6.5% vs. 27.3%, RR 0.24 (0.07, 0.78),  p  = 0.018] representing a risk reduction of 76%. The PP analysis showed similar results.
Conclusion


This specific whey-based pHF reduced the risk of AD development, particularly in those with a family history of AD, and tended to reduce the development of CMPA in non-exclusively breastfed infants at high-risk for allergy. The A.R.T. study suggests that this particular pHF may contribute to measures aimed at prevention of allergic manifestations. However, further studies are needed to confirm this risk-reduction effect.",2022,"AD incidence was significantly lower in those receiving pHF as compared to SF (10.6% vs. 18.7%,  p  = 0.024) with a relative risk (RR, 95% CI) of 0.54 (0.32, 0.92), in particular when adjusting for family history of AD [6.5% vs. 27.3%, RR 0.24 (0.07, 0.78),  p  = 0.018] representing a risk reduction of 76%.","['331 randomized subjects (ITT analysis set', 'healthy non-exclusively breastfed full-term infants', 'High-Risk Infants', ""cow's milk protein allergy (CMPA) and atopic dermatitis (AD) in infants at high-risk for allergy within the first 6 months of life""]","['partially hydrolyzed formulas (pHF', 'whey-based pHF', 'Intention-to-Treat (ITT) and Per-Protocol (PP', 'CMPA', 'Nutritional Intervention With a Partially Hydrolyzed Whey-Based Formula', ""specific whey-based pHF or a standard cow's milk-based formula (SF""]","['CMPA', 'AD incidence']","[{'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0419437', 'cui_str': 'High risk infant'}, {'cui': 'C0440448', 'cui_str': ""Cow's milk protein""}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0440448', 'cui_str': ""Cow's milk protein""}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}]","[{'cui': 'C0440448', 'cui_str': ""Cow's milk protein""}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",331.0,0.326646,"AD incidence was significantly lower in those receiving pHF as compared to SF (10.6% vs. 18.7%,  p  = 0.024) with a relative risk (RR, 95% CI) of 0.54 (0.32, 0.92), in particular when adjusting for family history of AD [6.5% vs. 27.3%, RR 0.24 (0.07, 0.78),  p  = 0.018] representing a risk reduction of 76%.","[{'ForeName': 'Nicolaos', 'Initials': 'N', 'LastName': 'Nicolaou', 'Affiliation': 'Asthma and Allergy Centre, Limassol, Cyprus.'}, {'ForeName': 'Rouzha', 'Initials': 'R', 'LastName': 'Pancheva', 'Affiliation': 'Department of Hygiene and Epidemiology, Faculty of Public Health, Medical University of Varna, Varna, Bulgaria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Karaglani', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sekkidou', 'Affiliation': 'Asthma and Allergy Centre, Limassol, Cyprus.'}, {'ForeName': 'Miglena', 'Initials': 'M', 'LastName': 'Marinova-Achkar', 'Affiliation': 'Department of Hygiene and Epidemiology, Faculty of Public Health, Medical University of Varna, Varna, Bulgaria.'}, {'ForeName': 'Simoneta', 'Initials': 'S', 'LastName': 'Popova', 'Affiliation': 'Department of Hygiene and Epidemiology, Faculty of Public Health, Medical University of Varna, Varna, Bulgaria.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Tzaki', 'Affiliation': 'General Hospital Elena Venizelou, Athens, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Kapetanaki', 'Affiliation': 'General Hospital Elena Venizelou, Athens, Greece.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Iacovidou', 'Affiliation': 'Neonatal Department, National and Kapodistrian University of Athens, Aretaieio Hospital, Athens, Greece.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Boutsikou', 'Affiliation': 'Neonatal Department, National and Kapodistrian University of Athens, Aretaieio Hospital, Athens, Greece.'}, {'ForeName': 'Zoi', 'Initials': 'Z', 'LastName': 'Iliodromiti', 'Affiliation': 'Neonatal Department, National and Kapodistrian University of Athens, Aretaieio Hospital, Athens, Greece.'}, {'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Papaevangelou', 'Affiliation': 'Third Department of Pediatrics, National and Kapodistrian University of Athens, ATTIKON General University Hospital, Athens, Greece.'}, {'ForeName': 'Olympia', 'Initials': 'O', 'LastName': 'Sardeli', 'Affiliation': 'Third Department of Pediatrics, National and Kapodistrian University of Athens, ATTIKON General University Hospital, Athens, Greece.'}, {'ForeName': 'Paraskevi', 'Initials': 'P', 'LastName': 'Xepapadaki', 'Affiliation': 'Allergy Department, 2nd Pediatric Clinic, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Papathoma', 'Affiliation': 'Neonatal Intensive Care Unit, Alexandra University and State Maternity Hospital, Athens, Greece.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Thijs-Verhoeven', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Kudla', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Laurien H', 'Initials': 'LH', 'LastName': 'Ulfman', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schaafsma', 'Affiliation': 'FrieslandCampina, Amersfoort, Netherlands.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece.'}]",Frontiers in nutrition,['10.3389/fnut.2022.863599']
1616,35694563,Vasopressin for Post-kidney Transplant Hypotension.,"Introduction


Hypotension after deceased donor kidney transplant (DDKT) is a risk factor for delayed graft function (DGF) and poor graft survival (GS). We hypothesize that vasopressin use in hypotensive DDKT recipients (DDKTRs) to increase blood pressure (BP) reduces DGF rates and is safe without increasing mortality.
Methods


Group with vasopressin ""study group"" ( n =  45) was defined as DDKTRs between 2012 and 2017 who required vasopressin for hypotension systolic BP (SBP) <120 mm Hg or diastolic BP (DBP) <60 mm Hg. DDKTRs with no-vasopressin ""comparison group"" ( n =  90) were propensity score-matched DDKTRs between 2012 and 2017 without vasopressin use. Primary outcomes were GS, creatinine and allograft biopsy rate at 1 year, DGF rate, and death during transplant hospitalization.
Results


Vasopressin group had lower mean maximum and minimum SBP and DBP in the operating room (OR). Median vasopressin start time post-DDKT was 2 hours (interquartile range [IQR] 1-6), and duration of use was 42 hours (IQR 24-63). DGF, creatinine at 1 year, and allograft biopsy rates were comparable. No deaths occurred during transplant hospitalization. Multivariable analysis did not find an effect of vasopressin use on GS.
Conclusion


Treatment of hypotensive DDKTRs with vasopressin is safe and facilitated similar graft function and survival with that of nonhypotensive patients. In the absence of a randomized control trial, our study supports the safety of vasopressin therapy to prevent the adverse effects of hypotension.",2022,"Conclusion


Treatment of hypotensive DDKTRs with vasopressin is safe and facilitated similar graft function and survival with that of nonhypotensive patients.",['Post-kidney Transplant Hypotension'],"['Vasopressin', 'vasopressin', 'vasopressin ', 'vasopressin therapy']","['Median vasopressin start time', 'DGF, creatinine at 1 year, and allograft biopsy rates', 'mean maximum and minimum SBP and DBP', 'deaths', 'hypotension systolic BP (SBP)\xa0<120 mm\xa0Hg or diastolic BP (DBP', 'blood pressure (BP) reduces DGF rates', 'adverse effects of hypotension', 'delayed graft function (DGF) and poor graft survival (GS', 'GS, creatinine and allograft biopsy rate at 1 year, DGF rate, and death during transplant hospitalization']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]","[{'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C1301880', 'cui_str': 'Start time'}, {'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",90.0,0.0451295,"Conclusion


Treatment of hypotensive DDKTRs with vasopressin is safe and facilitated similar graft function and survival with that of nonhypotensive patients.","[{'ForeName': 'Muhammad Y', 'Initials': 'MY', 'LastName': 'Jan', 'Affiliation': 'Division of Nephrology and Hypertension, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Moe', 'Affiliation': 'Division of Nephrology and Hypertension, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Oluwafisayo', 'Initials': 'O', 'LastName': 'Adebiyi', 'Affiliation': 'Division of Nephrology and Hypertension, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Indiana University Health, Indianapolis, Indiana, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Powelson', 'Affiliation': 'Division Transplant Surgery, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Burney', 'Affiliation': 'Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Muhammad S', 'Initials': 'MS', 'LastName': 'Yaqub', 'Affiliation': 'Division of Nephrology and Hypertension, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Dennis P', 'Initials': 'DP', 'LastName': 'Mishler', 'Affiliation': 'Division of Nephrology and Hypertension, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ranjani N', 'Initials': 'RN', 'LastName': 'Moorthi', 'Affiliation': 'Division of Nephrology and Hypertension, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Tim E', 'Initials': 'TE', 'LastName': 'Taber', 'Affiliation': 'Division of Nephrology and Hypertension, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Anderson', 'Affiliation': 'Division of Nephrology and Hypertension, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Fridell', 'Affiliation': 'Division Transplant Surgery, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goggins', 'Affiliation': 'Division Transplant Surgery, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Asif A', 'Initials': 'AA', 'LastName': 'Sharfuddin', 'Affiliation': 'Division of Nephrology and Hypertension, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}]",Kidney international reports,['10.1016/j.ekir.2022.03.035']
1617,35694435,Does Dispositional Mindfulness Predict Cardiovascular Reactivity to Emotional Stress in Prehypertension? Latent Growth Curve Analyses from the Serenity Study.,"OBJECTIVE


Mindfulness stress buffering theory (Creswell & Lindsay, 2014) posits higher dispositional (trait) mindfulness can protect cardiovascular health by buffering physiological stress reactivity - a risk marker for hypertension and cardiac events. Yet, empirical evidence is mixed. This study used baseline data from the Serenity Study - a recently completed, two-site randomized clinical trial - to assess the link between trait mindfulness and cardiovascular stress reactivity in adults with unmedicated prehypertension (n=153, M age =50, 47% male, 69% White, 28% African-American).
METHODS


Latent growth curve modeling was used to determine whether specific facets of trait mindfulness, measured by the Five Facet Mindfulness Questionnaire and the Decentering subscale of the Experiences Questionnaire, predict blood pressure (BP) and heart rate (HR) responses to a brief laboratory stressor (5-min anger recall task). BP and HR taken 1-min apart were used in latent growth curve models. We hypothesized after controlling for known covariates of cardiovascular health, higher trait mindfulness would predict lower cardiovascular reactivity to, and faster recovery from, acute emotional stress.
RESULTS


Contrary to predictions, no mindfulness facets predicted cardiovascular reactivity or recovery.
CONCLUSIONS


These findings indicate trait mindfulness facets may not independently affect BP and HR responses to acute emotional stress among prehypertensive but otherwise healthy adults with normal stress levels, prior to mindfulness training. Mindfulness-based interventions may therefore be necessary to engender benefits of mindfulness on stress physiology, as a putative biological mechanism of cardiovascular risk reduction and health promotion.
Trial registration number and date of registration


NCT02371317, 1/21/2015.",2021,"Contrary to predictions, no mindfulness facets predicted cardiovascular reactivity or recovery.
","['adults with unmedicated prehypertension (n=153, M age =50, 47% male, 69% White, 28% African-American']","['Mindfulness stress buffering theory (Creswell & Lindsay, 2014) posits higher dispositional (trait) mindfulness']","['Five Facet Mindfulness Questionnaire and the Decentering subscale of the Experiences Questionnaire, predict blood pressure (BP) and heart rate (HR) responses to a brief laboratory stressor (5-min anger recall task', 'cardiovascular reactivity or recovery', 'BP and HR responses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}]",,0.105183,"Contrary to predictions, no mindfulness facets predicted cardiovascular reactivity or recovery.
","[{'ForeName': 'Gabrielle R', 'Initials': 'GR', 'LastName': 'Chin', 'Affiliation': 'Rowan University, Department of Psychology, College of Science and Mathematics, Glassboro, NJ.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Greeson', 'Affiliation': 'Rowan University, Department of Psychology, College of Science and Mathematics, Glassboro, NJ.'}, {'ForeName': 'Joel W', 'Initials': 'JW', 'LastName': 'Hughes', 'Affiliation': 'Kent State University, Department of Psychology, Kent, OH.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fresco', 'Affiliation': 'Kent State University, Department of Psychology, Kent, OH.'}]",Mindfulness,['10.1007/s12671-021-01745-y']
1618,35694402,Effects of Intermittent Hypoxia-Hyperoxia Exposure Prior to Aerobic Cycling Exercise on Physical and Cognitive Performance in Geriatric Patients-A Randomized Controlled Trial.,"Background:  It was recently shown that intermittent hypoxic-hyperoxic exposure (IHHE) applied prior to a multimodal training program promoted additional improvements in cognitive and physical performance in geriatric patients compared to physical training only. However, there is a gap in the literature to which extent the addition of IHHE can enhance the effects of an aerobic training. Therefore, the aim of this study was to investigate the efficacy of IHHE applied prior to aerobic cycling exercise on cognitive and physical performance in geriatric patients.  Methods:  In a randomized, two-armed, controlled, and single-blinded trial, 25 geriatric patients (77-94 years) were assigned to two groups: intervention group (IG) and sham control group (CG). Both groups completed 6 weeks of aerobic training using a motorized cycle ergometer, three times a week for 20 min per day. The IG was additionally exposed to intermittent hypoxic and hyperoxic periods for 30 min prior to exercise. The CG followed the similar procedure breathing sham hypoxia and hyperoxia (i.e., normoxia). Within 1 week before and after the interventions, cognitive performance was assessed with the Dementia-Detection Test (DemTect) and the Clock Drawing Test (CDT), while physical performance was measured using the Timed ""Up and Go"" Test (TUG) and the Short-Physical-Performance-Battery (SPPB).  Results:  No interaction effect was found with respect to the DemTect ( η   p   2  = 0.02). An interaction effect with medium effect size ( η   p   2  = 0.08) was found for CDT performance with a higher change over time for IG ( d  = 0.57) compared to CG ( d  = 0.05). The ANCOVA with baseline-adjustment indicated between-group differences with a large and medium effect size at post-test for the TUG ( η   p   2  = 0.29) and SPPB ( η   p   2  = 0.06) performance, respectively, in favour of the IG. Within-group post-hoc analysis showed that the TUG performance was worsened in the CG ( d  = 0.65) and remained unchanged in the IG ( d  = 0.19). Furthermore, SPPB performance was increased ( d  = 0.58) in IG, but no relevant change over time was found for CG ( d  = 0.00).  Conclusion:  The current study suggests that an additional IHHE prior to aerobic cycling exercise seems to be more effective to increase global cognitive functions as well as physical performance and to preserve functional mobility in geriatric patients in comparison to aerobic exercise alone after a 6-week intervention period.",2022,"Furthermore, SPPB performance was increased ( d  = 0.58) in IG, but no relevant change over time was found for CG ( d  = 0.00).  ","['Geriatric Patients', 'geriatric patients', '25 geriatric patients (77-94\xa0years']","['Intermittent Hypoxia-Hyperoxia Exposure Prior to Aerobic Cycling Exercise', 'aerobic cycling exercise', 'aerobic training', 'IHHE', 'aerobic exercise alone', 'intervention group (IG) and sham control group (CG']","['global cognitive functions', 'SPPB performance', 'CDT performance', 'cognitive and physical performance', 'Dementia-Detection Test (DemTect) and the Clock Drawing Test (CDT), while physical performance', 'Physical and Cognitive Performance', 'TUG performance', 'SPPB']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0054696', 'cui_str': 'Carbohydrate deficient transferrin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}]",25.0,0.0226284,"Furthermore, SPPB performance was increased ( d  = 0.58) in IG, but no relevant change over time was found for CG ( d  = 0.00).  ","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Behrendt', 'Affiliation': 'Department for Sport Science, Chair for Health and Physical Activity, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bielitzki', 'Affiliation': 'Department for Sport Science, Chair for Health and Physical Activity, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Behrens', 'Affiliation': 'Department for Sport Science, Chair for Health and Physical Activity, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Oleg S', 'Initials': 'OS', 'LastName': 'Glazachev', 'Affiliation': 'Department Human Physiology, Institute of Clinical Medicine, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Schega', 'Affiliation': 'Department for Sport Science, Chair for Health and Physical Activity, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2022.899096']
1619,35694401,The Effect of Whole-Body Traditional and Functional Resistance Training on CAVI and Its Association With Muscular Fitness in Untrained Young Men.,"Background:  Resistance training-induced changes in the muscle function is essential for the health promotion of the young and older, but the discrepancies of the effect of resistance training on arterial stiffness leads to the divergence regarding to the effect of resistance training on cardiovascular health. What confuses our understanding in this field may be the following factors: external load (higher intensity vs. lighter intensity), participants' cardiovascular health, and arterial stiffness assessment measurement. The purpose of the present study was to investigate the effects of the whole-body traditional high-intensity vs. functional low-intensity resistance training protocol on systemic arterial stiffness, and their association with muscular fitness components in untrained young men.  Methods:  In this randomized controlled trial, twenty-nine untrained young men (mean age about 22.5 years old) were randomized into a 6-weeks (three sessions per week) supervised whole-body traditional high-intensity resistance group (TRT,  n  = 15) consisting of 4-5 sets of 12 repetitions (70%1RM, lower-repetitions) or a whole-body functional low-intensity resistance group (FRT,  n  = 14) with 4-5 sets of 20 repetitions (40%1RM, higher-repetitions) to volitional failure. The systemic arterial stiffness (cardio-ankle vascular index, CAVI) and muscular fitness components were assessed before and after the 6-weeks training program.  Results:  There was a significant decrease (pre-post) for CAVI only in FRT group ( p  < 0.05), but no significant difference was observed between two groups. In addition, the TRT and FRT groups showed equally significantly increased in maximal strength, muscular endurance and power (within group: both  p  < 0.01); however, the independent  t  test exhibited that the difference between two groups in terms of change in maximal strength, muscular endurance and power were no significant ( p  > 0.05). Furthermore, the reduction in CAVI was negatively correlated with the increase in 1RM of bench press for all participants (r = -0.490,  p  < 0.01).  Conclusion: Using present criterion-standard assessments measurements demonstrates that CAVI was significantly reduced after 6-weeks functional resistance training with beneficial effect on muscular fitness. Negative and significant association between CAVI and 1RM bench press indicated the cardiovascular health may be involved in the regulation of resistance training.",2022,"There was a significant decrease (pre-post) for CAVI only in FRT group ( p  < 0.05), but no significant difference was observed between two groups.","['untrained young men', 'twenty-nine untrained young men (mean age about 22.5\xa0years old', 'Untrained Young Men']","['supervised whole-body traditional high-intensity resistance group (TRT,  n  = 15) consisting of 4-5 sets of 12 repetitions (70%1RM, lower-repetitions) or a whole-body functional low-intensity resistance group (FRT,  n  = 14) with 4-5 sets of 20 repetitions (40%1RM, higher-repetitions) to volitional failure', 'whole-body traditional high-intensity vs. functional low-intensity resistance training protocol', 'TRT and FRT', 'Whole-Body Traditional and Functional Resistance Training']","['systemic arterial stiffness (cardio-ankle vascular index, CAVI) and muscular fitness components', 'maximal strength, muscular endurance and power', '1RM of bench press', 'muscular fitness', 'CAVI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}, {'cui': 'C0085979', 'cui_str': 'Genus Cavia'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}]",29.0,0.00758076,"There was a significant decrease (pre-post) for CAVI only in FRT group ( p  < 0.05), but no significant difference was observed between two groups.","[{'ForeName': 'Chongwen', 'Initials': 'C', 'LastName': 'Zuo', 'Affiliation': 'Graduate Department of Capital University of Physical Education and Sports, Beijing, China.'}, {'ForeName': 'Shumin', 'Initials': 'S', 'LastName': 'Bo', 'Affiliation': 'School of Kinesiology and Health of Capital University of Physical Education and Sports, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Graduate Department of Capital University of Physical Education and Sports, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Graduate Department of Capital University of Physical Education and Sports, Beijing, China.'}]",Frontiers in physiology,['10.3389/fphys.2022.888048']
1620,35694399,Cancer and Associated Therapies Impact the Skeletal Muscle Proteome.,"Introduction:  Both cancer and cancer associated therapies (CAT; including chemotherapy or concurrent chemoradiation) disrupt cellular metabolism throughout the body, including the regulation of skeletal muscle mass and function. Adjunct testosterone therapy during standard of care chemotherapy and chemoradiation modulates CAT-induced dysregulation of skeletal muscle metabolism and protects lean body mass during CAT. However, the extent to which the skeletal muscle proteome is altered under these therapeutic conditions is unknown.  Objective:  We probed the skeletal muscle proteome of cancer patients as an ancillary analysis following a randomized, double-blind, placebo-controlled phase II trial investigating the effect of adjunct testosterone on body composition in men and women with advanced cancers undergoing CAT.  Methods:  Men and women diagnosed with late stage (≥IIB) or recurrent head and neck or cervical cancer who were scheduled to receive standard of care CAT were administered an adjunct 7 weeks treatment of weekly intramuscular injections of either 100 mg testosterone (CAT+T,  n  = 7; 2M/5F) or placebo/saline (CAT+P,  n  = 6; 4M/2F). Biopsies were performed on the vastus lateralis before (PRE) and after (POST) the 7 weeks treatment. Extracted proteins were separated with 2-dimensional gel electrophoresis (2DE), and subjected to analyses of total protein abundance, phosphorylation and S-nitrosylation. Proteoforms showing significant 1.5 fold differences ( t -test  p  ≤ 0.05) between PRE and POST timepoints were identified by mass spectroscopy (MS), and lists of altered proteins were subjected to Gene Set Enrichment Analysis (GSEA) to identify affected pathways.  Results:  A total of 756 distinct protein spots were identified. Of those spots, 102 were found to be altered in terms of abundance, phosphorylation, or S-nitrosylation, and identified by mass spectroscopy analysis to represent 58 unique proteins. Among the biological processes and pathways identified, CAT+P predominantly impacted metabolic processes, cell assembly, oxygen transport, and apoptotic signaling, while CAT+T impacted transcription regulation, muscle differentiation, muscle development, and contraction.  Conclusion:  Cancer and CAT significantly altered the skeletal muscle proteome in a manner suggestive of loss of structural integrity, reduced contractile function, and disrupted metabolism. Proteomic analysis suggests that the addition of adjunct testosterone minimized the structural and contractile influence of cancer and its associated therapies.",2022,"Of those spots, 102 were found to be altered in terms of abundance, phosphorylation, or S-nitrosylation, and identified by mass spectroscopy analysis to represent 58 unique proteins.","['cancer patients', 'Men and women diagnosed with late stage (≥IIB) or recurrent head and neck or cervical cancer who were scheduled to receive', 'men and women with advanced cancers undergoing CAT']","['2-dimensional gel electrophoresis (2DE', 'adjunct testosterone', 'Adjunct testosterone therapy', 'chemotherapy or concurrent chemoradiation', 'testosterone (CAT+T,  n  = 7;\u20092M/5F) or placebo/saline (CAT+P,  n  = 6; 4M/2F', 'placebo', 'standard of care CAT']",['body composition'],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}]","[{'cui': 'C0013860', 'cui_str': 'Electrophoresis, Gel, Two Dimensional'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.267129,"Of those spots, 102 were found to be altered in terms of abundance, phosphorylation, or S-nitrosylation, and identified by mass spectroscopy analysis to represent 58 unique proteins.","[{'ForeName': 'Dillon', 'Initials': 'D', 'LastName': 'E L', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, United States.'}, {'ForeName': 'Wright', 'Initials': 'W', 'LastName': 'T J', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, College Station, TX, United States.'}, {'ForeName': 'Filley', 'Initials': 'F', 'LastName': 'A R', 'Affiliation': 'Department of Biomedical Sciences, Texas A&M University, College Station, TX, United States.'}, {'ForeName': 'Pulliam', 'Initials': 'P', 'LastName': 'A B', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, College Station, TX, United States.'}, {'ForeName': 'Randolph', 'Initials': 'R', 'LastName': 'K M', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, College Station, TX, United States.'}, {'ForeName': 'Danesi', 'Initials': 'D', 'LastName': 'C P', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, United States.'}, {'ForeName': 'Gilkison', 'Initials': 'G', 'LastName': 'C R', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, United States.'}, {'ForeName': 'Wiktorowicz', 'Initials': 'W', 'LastName': 'J E', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, United States.'}, {'ForeName': 'Soman', 'Initials': 'S', 'LastName': 'K V', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, United States.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'R J', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, United States.'}, {'ForeName': 'Sheffield-Moore', 'Initials': 'SM', 'LastName': 'M', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, United States.'}]",Frontiers in physiology,['10.3389/fphys.2022.879263']
1621,35694390,"Influence of Long-Lasting Static Stretching on Maximal Strength, Muscle Thickness and Flexibility.","Background:  In animal studies long-term stretching interventions up to several hours per day have shown large increases in muscle mass as well as maximal strength. The aim of this study was to investigate the effects of a long-term stretching on maximal strength, muscle cross sectional area (MCSA) and range of motion (ROM) in humans.  Methods:  52 subjects were divided into an Intervention group (IG,  n  = 27) and a control group (CG,  n  = 25). IG stretched the plantar flexors for one hour per day for six weeks using an orthosis. Stretching was performed on one leg only to investigate the contralateral force transfer. Maximal isometric strength (MIS) and 1RM were both measured in extended knee joint. Furthermore, we investigated the MCSA of IG in the lateral head of the gastrocnemius (LG) using sonography. Additionally, ROM in the upper ankle was investigated  via  the functional ""knee to wall stretch"" test (KtW) and a goniometer device on the orthosis. A two-way ANOVA was performed in data analysis, using the Scheffé Test as post-hoc test.  Results:  There were high time-effects ( p  = 0.003, ƞ² = 0.090) and high interaction-effect ( p  < 0.001, ƞ²=0.387) for MIS and also high time-effects ( p  < 0.001, ƞ²=0.193) and interaction-effects ( p  < 0.001, ƞ²=0,362) for 1RM testing. Furthermore, we measured a significant increase of 15.2% in MCSA of LG with high time-effect ( p  < 0.001, ƞ²=0.545) and high interaction-effect ( p =0.015, ƞ²=0.406). In ROM we found in both tests significant increases up to 27.3% with moderate time-effect ( p  < 0.001, ƞ²=0.129) and high interaction-effect ( p  < 0.001, ƞ²=0.199). Additionally, we measured significant contralateral force transfers in maximal strength tests of 11.4% ( p  < 0.001) in 1RM test and 1.4% ( p =0.462) in MIS test. Overall, there we no significant effects in control situations for any parameter (CG and non-intervened leg of IG).  Discussion:  We hypothesize stretching-induced muscle damage comparable to effects of mechanical load of strength training, that led to hypertrophy and thus to an increase in maximal strength. Increases in ROM could be attributed to longitudinal hypertrophy effects, e.g., increase in serial sarcomeres. Measured cross-education effects could be explained by central neural adaptations due to stimulation of the stretched muscles.",2022,"Overall, there we no significant effects in control situations for any parameter (CG and non-intervened leg of IG).  ","['humans', '52 subjects']","['Long-Lasting Static Stretching', 'strength training', 'long-term stretching']","['Maximal Strength, Muscle Thickness and Flexibility', 'plantar flexors', 'Maximal isometric strength (MIS) and 1RM', 'high time-effects', 'maximal strength', 'maximal strength, muscle cross sectional area (MCSA) and range of motion (ROM', 'interaction-effects']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",52.0,0.0158756,"Overall, there we no significant effects in control situations for any parameter (CG and non-intervened leg of IG).  ","[{'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Warneke', 'Affiliation': 'Department for Exercise, Sport and Health, Leuphana University, Lüneburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Brinkmann', 'Affiliation': 'Assistive Systems and Medical Device Technology, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hillebrecht', 'Affiliation': 'Assistive Systems and Medical Device Technology, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schiemann', 'Affiliation': 'Department for Exercise, Sport and Health, Leuphana University, Lüneburg, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2022.878955']
1622,35694856,A low-intensity behavioral intervention for depression in older adults delivered by lay coaches: proof-of-concept trial.,"OBJECTIVES


A broader workforce is necessary to expand U.S. geriatric mental health services. We examined (1) feasibility of training undergraduate students to deliver Do More, Feel Better (DMFB), an evidence-informed program for depression; and (2) feasibility, acceptability, and outcomes in a single-arm proof-of-concept trial.
METHOD


In Study 1, we taught DMFB to 18 upper-level undergraduate students and assessed fidelity using role plays. In Study 2, four students delivered six weekly DMFB sessions to 12 community-dwelling older adults ( M  = 66.83 years old,  SD  = 10.39) with depression (PHQ ≥ 10). Patient outcomes were change in pre- to post-treatment depressive symptoms, disability, and the target mechanism of increased activity.
RESULTS


Fidelity was high in the course (Study 1; 82.4% of role plays rated as 'passing') and the trial (Study 2; 100% of 24 sessions rated as 'passing'). The majority (83.3%) of patients were retained and evidenced statistically and clinically significant improvement in depressive symptoms (Hamilton Rating Scale for Depression [HAM-D]), disability (World Health Organization's Disability Assessment Schedule 2.0 [WHODAS 2.0], and activity (Behavioral Activation for Depression Scale [BADS]).
CONCLUSION


It is feasible to train bachelor's-level students to deliver a brief, structured intervention for depression. Future research should consider implementation strategies and stakeholder feedback.",2022,The majority (83.3%) of patients were retained and evidenced statistically and clinically significant improvement in depressive symptoms (Hamilton Rating Scale for Depression,"['12 community-dwelling older adults ( M \u2009=\u200966.83\u2009years old,  SD \u2009=\u200910.39) with depression (PHQ ≥ 10', 'older adults delivered by lay coaches', 'training undergraduate students', '18 upper-level undergraduate students']","['DMFB sessions', 'low-intensity behavioral intervention']","['depressive symptoms (Hamilton Rating Scale for Depression', 'change in pre- to post-treatment depressive symptoms, disability, and the target mechanism of increased activity', ""HAM-D]), disability (World Health Organization's Disability Assessment Schedule 2.0 [WHODAS 2.0], and activity (Behavioral Activation for Depression Scale [BADS""]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0474395', 'cui_str': 'Behavior showing increased motor activity'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C4304971', 'cui_str': 'WHODAS (World Health Organization Disability Assessment Schedule) 2.0'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.0334251,The majority (83.3%) of patients were retained and evidenced statistically and clinically significant improvement in depressive symptoms (Hamilton Rating Scale for Depression,"[{'ForeName': 'Brenna N', 'Initials': 'BN', 'LastName': 'Renn', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Nichole', 'Initials': 'N', 'LastName': 'Sams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Areán', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}]",Aging & mental health,['10.1080/13607863.2022.2084709']
1623,35694836,Ureteroenteric Stricture Outcomes: Secondary analysis of an RCT comparing open vs robotic cystectomy.,"OBJECTIVES


To analyze the risk of ureteroenteric anastomotic stricture in patients randomized to open or robotic cystectomy with extracorporeal urinary diversion.
PATIENTS AND METHODS


We included 118 patients randomized to robotic (n=60) or open (n=58) cystectomy at a single, high-volume institution from March 2010 to April 2013. Urinary diversion was performed by experienced open surgeons. Stricture was defined as non-malignant obstruction on imaging, corroborated by clinical status, and requiring procedural intervention. The risk of stricture within 1 year was compared between groups using Fisher's exact test.
RESULTS


Fifty-eight and 60 patients were randomized to robotic and open cystectomy, respectively. We identified 5 strictures, all in the open group. In patients with at least 1 year of follow-up, the increase in risk of stricture from open surgery was 9.3% (95% CI 1.5%, 17%). Of the 5 strictures, 3 were managed endoscopically while 2 required open revision. There was no evidence that perioperative grade 3-5 complication were associated with development of a stricture (p=1) and no evidence of a difference in 24-month estimated glomerular filtration rate between arms (p=0.15).
CONCLUSIONS


In this study at a high volume center, robotic cystectomy with extracorporeal urinary diversion achieved excellent ureteral anastomotic outcomes. Purported increased risk of stricture is not a reason to avoid robot-assisted radical cystectomy. Future research should examine the impact of different surgical techniques and operator experience on the risk of stricture, especially as more intracorporeal diversions are performed.",2022,"There was no evidence that perioperative grade 3-5 complication were associated with development of a stricture (p=1) and no evidence of a difference in 24-month estimated glomerular filtration rate between arms (p=0.15).
","['118 patients randomized to robotic (n=60) or open (n=58) cystectomy at a single, high-volume institution from March 2010 to April 2013', 'Fifty-eight and 60 patients']","['robotic and open cystectomy', 'RCT comparing open vs robotic cystectomy', 'robotic cystectomy with extracorporeal urinary diversion']","['risk of stricture', 'Urinary diversion', 'perioperative grade 3-5 complication', 'risk of stricture from open surgery', 'glomerular filtration rate', 'excellent ureteral anastomotic outcomes']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0042020', 'cui_str': 'Urinary diversion procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0042020', 'cui_str': 'Urinary diversion procedure'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",118.0,0.0483408,"There was no evidence that perioperative grade 3-5 complication were associated with development of a stricture (p=1) and no evidence of a difference in 24-month estimated glomerular filtration rate between arms (p=0.15).
","[{'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Assel', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Benjamin B', 'Initials': 'BB', 'LastName': 'Beech', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Benfante', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Sjoberg', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Touijer', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Coleman', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Dalbagni', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Harry W', 'Initials': 'HW', 'LastName': 'Herr', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'S Machele', 'Initials': 'SM', 'LastName': 'Donat', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Laudone', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Vickers', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Bernard H', 'Initials': 'BH', 'LastName': 'Bochner', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",BJU international,['10.1111/bju.15825']
1624,35694835,Effect of three different remineralizing agents on artificial erosive lesions of primary teeth.,"BACKGROUND


This study aimed to investigate the efficacy of three remineralizing agents on dental erosion in primary teeth.
METHODS


Forty primary molars were randomly divided into four groups (n = 10 each): self-assembling peptide (P 11-4  ), casein phosphopeptide-amorphous calcium fluoride phosphate (CPP-ACFP), sodium fluoride (NaF), and artificial saliva (AS; control). The erosion-like formation was created by immersing the samples in citric acid (4 × 2 min, pH 2.3) and AS (4 × 2 h, pH 7). The eroded samples were then treated with remineralizing agents and subjected to further erosion consisting of 15 cycles (3x/8-h interval) of immersion in citric acid and AS for 6 s each. Alterations in the mineral content and morphology of the samples were quantified using a microhardness tester and atomic force microscope.
RESULTS


All agents had a significant remineralization effect on eroded primary tooth enamel. After further erosive challenge, enamel loss in the CPP-ACFP group was found to be significantly lower than in all other groups, and no significant difference was found between the P 11-4  and NaF groups.
CONCLUSIONS


This study demonstrated that all tested materials had remineralization ability, and CPP-ACFP had a superior effect in inhibiting enamel loss due to dental erosion in primary teeth. © 2022 Australian Dental Association.",2022,"After further erosive challenge, enamel loss in the CPP-ACFP group was found to be significantly lower than in all other groups, and no significant difference was found between the P 11-4  and NaF groups.
","['dental erosion in primary teeth', '© 2022 Australian Dental Association', 'Forty primary molars', 'artificial erosive lesions of primary teeth']","['remineralizing agents', 'self-assembling peptide (P 11-4  ), casein phosphopeptide-amorphous calcium fluoride phosphate (CPP-ACFP), sodium fluoride (NaF), and artificial saliva (AS; control']","['erosion-like formation', 'enamel loss', 'eroded primary tooth enamel']","[{'cui': 'C0040436', 'cui_str': 'Erosion of teeth'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0069877', 'cui_str': 'P 11'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C0006695', 'cui_str': 'Calcium Fluoride'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}]",40.0,0.0461901,"After further erosive challenge, enamel loss in the CPP-ACFP group was found to be significantly lower than in all other groups, and no significant difference was found between the P 11-4  and NaF groups.
","[{'ForeName': 'Nilüfer', 'Initials': 'N', 'LastName': 'Üstün', 'Affiliation': 'Istanbul Medipol University, Faculty of Dentistry, Department of Pedodontics, Istanbul, Turkey.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Güven', 'Affiliation': 'Istanbul University, Faculty of Dentistry, Department of Pedodontics, Istanbul, Turkey.'}]",Australian dental journal,['10.1111/adj.12922']
1625,35688442,HTX-011 in Combination with Multimodal Analgesic Regimen Minimized Severe Pain and Opioid Use after Total Knee Arthroplasty in an Open-Label Study.,"Total knee arthroplasty (TKA) can be associated with significant postoperative pain despite multimodal analgesic (MMA) protocols, and most patients require the use of opioids postoperatively. HTX-011 is a dual-acting local anesthetic containing bupivacaine and low-dose meloxicam in an extended-release polymer. In a prior randomized controlled trial (RCT), HTX-011 reduced pain and opioid use through 72 hours after TKA compared with bupivacaine hydrochloride. This open-label study (NCT03974932) evaluated the efficacy and safety of HTX-011 combined with an MMA regimen in patients undergoing TKA under spinal anesthesia. All patients received intraoperative HTX-011 (400 mg bupivacaine/12 mg meloxicam) in combination with an MMA regimen consisting of preoperative acetaminophen, celecoxib, and pregabalin and postoperative acetaminophen and celecoxib until discharge. Opioid rescue was allowed upon patient request for additional pain control. Pain scores, opioid consumption, discharge readiness, and adverse events were recorded. Fifty-one patients were treated. Compared with the prior RCT, HTX-011 with this MMA regimen further lowered pain scores and reduced opioid use. Mean patient-reported pain scores remained in the mild range, and 82% of patients or more did not experience severe pain at any individual time point through 72 hours after surgery. Mean total opioid consumption was low over 72 hours: 24.8 morphine milligram equivalents (1-2 tablets of oxycodone 10 mg/day). Approximately 60% of patients were ready for discharge by 12 hours, and 39% were discharged without an opioid prescription and did not call back for pain management. The treatment regimen was well tolerated, and no added risk was observed with the addition of MMA. HTX-011 with an MMA regimen reduced postoperative pain and opioid use following TKA.",2022,Mean total opioid consumption was low over 72 hours: 24.8 morphine milligram equivalents (1-2 tablets of oxycodone 10 mg/day).,['patients undergoing TKA under spinal anesthesia'],"['bupivacaine hydrochloride', 'bupivacaine and low-dose meloxicam', 'intraoperative HTX-011 (400\u2009mg bupivacaine/12\u2009mg meloxicam', 'HTX-011 combined with an MMA regimen', 'oxycodone', 'HTX-011 with an MMA', 'acetaminophen, celecoxib, and pregabalin and postoperative acetaminophen and celecoxib', 'Total knee arthroplasty (TKA', 'HTX-011']","['experience severe pain', 'pain scores', 'efficacy and safety', 'call back for pain management', 'postoperative pain', 'Mean total opioid consumption', 'Pain scores, opioid consumption, discharge readiness, and adverse events', 'Mean patient-reported pain scores', 'Severe Pain and Opioid Use']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",51.0,0.139068,Mean total opioid consumption was low over 72 hours: 24.8 morphine milligram equivalents (1-2 tablets of oxycodone 10 mg/day).,"[{'ForeName': 'Gwo-Chin', 'Initials': 'GC', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Berkowitz', 'Affiliation': 'University Orthopedic and Joint Replacement Center, Tamarac, Florida.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hacker', 'Affiliation': 'Grossmont Orthopedic Medical Group, La Mesa, California.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Heron Therapeutics, Inc., San Diego, California.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Rechter', 'Affiliation': 'Department of Orthopaedic Surgery, Orthopaedic Associates, LLP, Houston, Texas.'}]",The journal of knee surgery,['10.1055/s-0042-1747945']
1626,35689289,Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial.,"BACKGROUND


Treatment of superficial venous reflux has been shown to improve ulcer healing time and reduce the risk of ulcer recurrence. Terminal ablation of the reflux source (TIRS) is an alternative to formal endovenous ablation or surgery which can be performed by injecting sclerosant foam into the peri-ulcer plexus of the veins. TIRS has been shown to be successful and in our experience is the option preferred by many patients, when offered as an alternative to axial ablation (AA).
AIM


To determine if the proportion of ulcers healed within 6 months of endovenous treatment differs between patients undergoing AA of varicose veins or TIRS by peri-ulcer foam sclerotherapy.
METHODS


AAVTIRS is an assessor-blinded randomised controlled trial. Patients will be recruited from a dedicated ulcer clinic in Roscommon University Hospital and from the vascular surgical clinics in University Hospital Galway. All patients attending the ulcer clinic will be screened for eligibility.
RANDOMISATION


Random computer-generated sequence is stratified by ulcer size. Allocation will be concealed using sealed opaque envelopes.
BLINDING


Assessors reviewing wounds at follow -p visits will be blinded to patient allocation.
PRIMARY ENDPOINT


The proportion of ulcers healed within 6 months of enrolment.
DISCUSSION


This will be the first time that TIRS has been evaluated with a properly powered randomised trial in the setting of venous ulcer management. Streamlining the management of venous ulcers has broad health economic benefits. If it is found that TIRS is superior or non-inferior to AA, then a less expensive, less invasive injection can be offered as an alternative to AA in an attempt to encourage the healing of venous ulcers. If AA is found to be superior to TIRS, then this would suggest that all patients undergoing ablation in the management of venous ulcers should have their superficial reflux fully treated, building on the evidence of the EVRA trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04484168. Registered on 23 July 2020.",2022,Terminal ablation of the reflux source (TIRS) is an alternative to formal endovenous ablation or surgery which can be performed by injecting sclerosant foam into the peri-ulcer plexus of the veins.,"['Patients will be recruited from a dedicated ulcer clinic in Roscommon University Hospital and from the vascular surgical clinics in University Hospital Galway', 'patients undergoing AA of varicose veins or TIRS by peri-ulcer foam sclerotherapy', 'All patients attending the ulcer clinic will be screened for eligibility']","['Terminal ablation of the reflux source (TIRS', 'Axial ablation versus terminal interruption of the reflux source (AAVTIRS', 'TIRS']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0454793', 'cui_str': 'Roscommon'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0454778', 'cui_str': 'Galway'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",[],,0.149721,Terminal ablation of the reflux source (TIRS) is an alternative to formal endovenous ablation or surgery which can be performed by injecting sclerosant foam into the peri-ulcer plexus of the veins.,"[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Keohane', 'Affiliation': 'University Hospital Galway, Galway, Ireland. columkeohane@rcsi.ie.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Westby', 'Affiliation': 'Roscommon University Hospital, Roscommon, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Twyford', 'Affiliation': 'University Hospital Galway, Galway, Ireland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ahern', 'Affiliation': 'University Hospital Galway, Galway, Ireland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Tawfick', 'Affiliation': 'University Hospital Galway, Galway, Ireland.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'University Hospital Galway, Galway, Ireland.'}]",Trials,['10.1186/s13063-022-06440-4']
1627,35689284,Immediate and six-week effects of wearing a knee sleeve following anterior cruciate ligament reconstruction on knee kinematics and kinetics: a cross-over laboratory and randomised clinical trial.,"BACKGROUND


Elastic knee sleeves are often worn following anterior cruciate ligament reconstruction (ACLR) but their effects on movement patterns are unclear.
AIM


To determine the immediate and six-week effects of wearing a knee sleeve on biomechanics of the knee during a step-down hop task.
METHODS


Using a cross-over design, we estimated sagittal plane knee kinematics and kinetics and stance duration during a step-down hop for 31 participants (age 26.0 [SD 6.6] years, 15 women) after ACLR (median 16 months post-surgery) with and without wearing a knee sleeve. In a subsequent randomised clinical trial, participants in the 'Sleeve Group' (n = 9) then wore the sleeve for 6 weeks at least 1 h daily, while a 'Control Group' (n = 9) did not wear the sleeve. We used statistical parametric mapping to compare (1) knee flexion/extension angle and external flexion/extension moment trajectories between three conditions at baseline (uninjured side, unsleeved injured side and sleeved injured side); (2) within-participant changes for knee flexion angles and external flexion/extension moment trajectories from baseline to follow-up between groups. We compared discrete flexion angles and moments, and stance duration between conditions and between groups.
RESULTS


Without sleeves, knee flexion was lower for the injured than the uninjured sides during mid-stance phase. When wearing the sleeve on the injured side, knee flexion increased during the loading phase of the stance phase. Discrete initial and peak knee flexion angles increased by (mean difference, 95% CIs) 2.7° (1.3, 4.1) and 3.0° (1.2, 4.9), respectively, when wearing the knee sleeve. Knee external flexion moments for the unsleeved injured sides were lower than the uninjured sides for 80% of stance phase, with no change when sleeved. The groups differenced for within-group changes in knee flexion trajectories at follow-up. Knee flexion angles increased for the Control group only. Stance duration decreased by 22% for the Sleeve group from baseline to follow-up (-89 ms; -153, -24) but not for the Controls.
CONCLUSIONS


Application of knee sleeves following ACLR is associated with improved knee flexion angles during hop landing training. Longer term (daily) knee sleeve application may help improve hop stance duration, potentially indicating improved hop performance.
TRIAL REGISTRATION


The trial was prospectively registered with the Australia New Zealand Clinical Trials Registry No: ACTRN12618001083280, 28/06/2018. ANZCTR.",2022,"Without sleeves, knee flexion was lower for the injured than the uninjured sides during mid-stance phase.","['31 participants (age 26.0 [SD 6.6] years, 15 women) after ACLR (median 16\xa0months post-surgery) with and without wearing a knee sleeve']","['anterior cruciate ligament reconstruction (ACLR', 'wearing a knee sleeve', ""Sleeve Group' (n\u2009=\u20099) then wore the sleeve for 6\xa0weeks at least 1\xa0h daily, while a 'Control Group' (n\u2009=\u20099) did not wear the sleeve"", 'anterior cruciate ligament reconstruction']","['knee kinematics and kinetics', 'Knee flexion angles', 'Stance duration', 'Discrete initial and peak knee flexion angles', 'knee flexion angles', 'Knee external flexion moments', 'knee flexion', 'sagittal plane knee kinematics and kinetics and stance duration', 'knee flexion trajectories']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}]",,0.173928,"Without sleeves, knee flexion was lower for the injured than the uninjured sides during mid-stance phase.","[{'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sole', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand. gisela.sole@otago.ac.nz.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lamb', 'Affiliation': 'School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Pataky', 'Affiliation': 'Graduate School of Medicine, Department of Human Health Sciences, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Anupa', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klima', 'Affiliation': ', Orthopaedicus, Leipzig, Germany.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Navarre', 'Affiliation': 'Southland Hospital, Invercargill, New Zealand and Clinical Senior Lecturer, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hammer', 'Affiliation': 'Division of Macroscopic and Clinical Anatomy, Gottfried Schatz Research Center, Medical University of Graz, Graz, Austria.'}]",BMC musculoskeletal disorders,['10.1186/s12891-022-05488-2']
1628,35689281,Creating 'Partnership in iSupport program' to optimise family carers' impact on dementia care: a randomised controlled trial protocol.,"BACKGROUND


The majority of people with dementia are cared for by their family members. However, family carers are often unprepared for their caring roles, receiving less education and support compared with professional carers. The consequences are their reduced mental and physical health and wellbeing, and that of care recipients. This study protocol introduces the 'Partnership in iSupport program' that includes five interventional components: managing transitions, managing dementia progression, psychoeducation, carer support group and feedback on services. This health services research is built on family carer and dementia care service provider partnerships. The aims of the study are to evaluate the effectiveness, cost-effectiveness and family carers' experiences in the program.
METHODS


A multicentre randomised controlled trial will be conducted with family carers of people living with dementia from two tertiary hospitals and two community aged care providers across three Australian states. The estimated sample size is 185 family carers. They will be randomly assigned to either the intervention group or the usual care group. Outcomes are measurable improvements in quality of life for carers and people with dementia, caregiving self-efficacy, social support, dementia related symptoms, and health service use for carers and their care recipients. Data will be collected at three time points: baseline, 6 months and 12 months post-initiation of the intervention.
DISCUSSION


This is the first large randomised controlled trial of a complex intervention on health and social care services with carers of people living with dementia in real-world practice across hospital and community aged care settings in three Australian states to ascertain the effectiveness, cost-effectiveness and carers' experiences of the innovative program. We expect that this study will address gaps in supporting dementia carers in health and social care systems while generating new knowledge of the mechanisms of change in the systems. Findings will strengthen proactive health management for both people living with dementia and their carers by embedding, scaling up and sustaining the 'Partnership in iSupport program' in the health and social care systems.
TRIAL REGISTRATION


The Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12622000199718 . Registered February 4 th , 2022.",2022,"Outcomes are measurable improvements in quality of life for carers and people with dementia, caregiving self-efficacy, social support, dementia related symptoms, and health service use for carers and their care recipients.","['family carers of people living with dementia from two tertiary hospitals and two community aged care providers across three Australian states', '185 family carers', 'health and social care services with carers of people living with dementia in real-world practice across hospital and community aged care settings in three Australian states']","['complex intervention', 'usual care group']","['quality of life for carers and people with dementia, caregiving self-efficacy, social support, dementia related symptoms, and health service use for carers and their care recipients', 'effectiveness, cost-effectiveness']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0868988,"Outcomes are measurable improvements in quality of life for carers and people with dementia, caregiving self-efficacy, social support, dementia related symptoms, and health service use for carers and their care recipients.","[{'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, South Australia, 5042, Australia. lily.xiao@flinders.edu.au.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, South Australia, 5042, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, South Australia, 5042, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Milte', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, South Australia, 5042, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, South Australia, 5042, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chapman', 'Affiliation': 'Canberra Health Services, ACT, Canberra, Australia.'}, {'ForeName': 'Langduo', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, South Australia, 5042, Australia.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Ullah', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Kitson', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, South Australia, 5042, Australia.'}, {'ForeName': 'Andre Queiroz', 'Initials': 'AQ', 'LastName': 'De Andrade', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, Clinical and Medical Sciences, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beattie', 'Affiliation': 'Queensland Dementia Training Study Centre, School of Nursing, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Brodaty', 'Affiliation': 'Centre for Healthy Brain Ageing (CHeBA), School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'McKechnie', 'Affiliation': 'Community Services, Resthaven Incorporated, Wayville, South Australia, Australia.'}, {'ForeName': 'Lee-Fay', 'Initials': 'LF', 'LastName': 'Low', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Tuan Anh', 'Initials': 'TA', 'LastName': 'Nguyen', 'Affiliation': 'Social Gerontology Division, National Ageing Research Institute, Melbourne, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Whitehead', 'Affiliation': 'Southern Adelaide Local Health Network, Adelaide, South Australia, Australia.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Brijnath', 'Affiliation': 'Social Gerontology Division, National Ageing Research Institute, Melbourne, Australia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Sinclair', 'Affiliation': 'Faculty of Sciences, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Voss', 'Affiliation': 'Southern Adelaide Local Health Network, Adelaide, South Australia, Australia.'}]",BMC health services research,['10.1186/s12913-022-08148-2']
1629,35689239,Efficacy and safety of HLX01 in patients with moderate-to-severe rheumatoid arthritis despite methotrexate therapy: a phase 3 study.,"BACKGROUND


To evaluate the efficacy and safety of HLX01, a rituximab biosimilar, as combination therapy with methotrexate in Chinese patients with active rheumatoid arthritis who had inadequate responses to methotrexate.
METHODS


In this double-blind, placebo-controlled phase 3 trial, biologic-naïve patients with moderate-to-severe active rheumatoid arthritis and inadequate responses to methotrexate were randomized 2:1 to receive 1000 mg HLX01 or placebo intravenously on days 1 and 15. On the first day of weeks 24 and 26, patients in both groups received 1000 mg HLX01 via intravenous infusion. The primary endpoint was the American College of Rheumatology (ACR) 20 response rate at week 24. Secondary endpoints including efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics were assessed up to week 48.
RESULTS


Between 28 May 2018 and 11 September 2020, 275 patients were randomized to the HLX01 group (n = 183) or the placebo group (n = 92). At week 24, the proportion of patients achieving ACR20 response was significantly greater in the HLX01 group compared with the placebo group in the intention-to-treat population (60.7% vs 35.9%; P < 0.001) and per-protocol set (60.3% vs 37.1%; P < 0.001). Most secondary efficacy endpoints favoured HLX01 when assessed at weeks 12, 24, 36 and 48. Incidences of treatment-emergent adverse events were similar between groups. Infusion-related reactions occurred more frequently following the initial two doses of HLX01 than the subsequent doses.
CONCLUSIONS


HLX01 plus methotrexate improved clinical outcomes compared with placebo in Chinese patients with rheumatoid arthritis who had inadequate responses to methotrexate. This treatment regimen was well tolerated, showing comparable safety profiles to placebo.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03522415 . Registered on 11 May 2018.",2022,Incidences of treatment-emergent adverse events were similar between groups.,"['Chinese patients with active rheumatoid arthritis who had inadequate responses to methotrexate', 'Between 28 May 2018 and 11 September 2020, 275 patients', 'patients with moderate-to-severe rheumatoid arthritis despite', 'Chinese patients with rheumatoid arthritis', 'naïve patients with moderate-to-severe active rheumatoid arthritis and inadequate responses to']","['HLX01', 'HLX01 or placebo', 'biologic', 'methotrexate therapy', 'HLX01 plus methotrexate', 'methotrexate', 'placebo']","['American College of Rheumatology (ACR) 20 response rate', 'Incidences of treatment-emergent adverse events', 'Efficacy and safety', 'HLX01', 'proportion of patients achieving ACR20 response', 'efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",275.0,0.486351,Incidences of treatment-emergent adverse events were similar between groups.,"[{'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Beijing, China. Zengxfpumc@163.com.'}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Rheumatology, Jiujiang No. 1 People's Hospital, Jiujiang, China.""}, {'ForeName': 'Xiumei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, First Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Rheumatology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiangping', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': ""Department of Nephrology, Chenzhou First People's Hospital, Chenzhou, China.""}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jiankang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Department of Rheumatology, Jiangxi Pingxiang People's Hospital, Pingxiang, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology and Immunology, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Rheumatology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Fu-Ai', 'Initials': 'FA', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Henlius Biotech, Inc., Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthritis research & therapy,['10.1186/s13075-022-02821-x']
1630,35689208,"Remimazolam tosilate compared with propofol for gastrointestinal endoscopy in elderly patients: a prospective, randomized and controlled study.","BACKGROUND


Remimazolam tosilate (HR7056, RT), a novel ultrashort-acting benzodiazepine, can be used for procedural sedation and general anaesthesia. However, few studies have focused on the sedative effect of RT during gastrointestinal endoscopy in elderly patients. The purpose of this study is to compare the sedative effect of RT and propofol for gastrointestinal endoscopy in elderly patients.
METHODS


A total of 82 patients aged ≥65 years with an American Society of Anaesthesiologists (ASA) grade I-II and a body mass index (BMI) of 18.0 to 30.0 kg/m 2  who were scheduled for gastrointestinal endoscopy from Jan 2021 to Aug 2021 were selected and randomly divided into a RT group and a propofol group. Alfentanil 5 μg/kg was used for analgesia in both groups. The RT group was given remimazolam tosilate 0.15 mg/kg with supplemental doses of 0.05 mg/kg as need, while the propofol group was given propofol 1.5 mg/kg with supplemental doses of 0.5 mg/kg. The supplemental doses were determined by the modified observational alertness/sedation assessment (MOAA/S) score and the patients' body movements. Sedative effects, such as the time to loss of consciousness (LOC) (MOAA/S score ≤ 1), successful sedation in one dose, number of supplemental doses after successful induction, and recovery time, were evaluated. Sedation-related side effects, such as injection pain, haemodynamic events and respiratory depression, were also noted. Postoperative nausea and vomiting (PONV), visual analogue scale (VAS) scores at rest, remedial analgesics, and dizziness or headache were recorded. In addition, patients' satisfaction and physician's satisfaction of the procedure were compared between the two groups.
RESULTS


Data from 77 patients were analysed. The success rate of sedation in both groups was 100%. The time to LOC (MOAA/S score ≤ 1) in the RT group was longer than that in the propofol group (20.7 ± 6.1s vs. 13.2 ± 5.2s, P < 0.001). There were fewer patients in the RT group reporting injection pain than that in the propofol group (0/39 vs. 5/38, P = 0.025). Haemodynamic events and respiratory depression in the RT group were less frequent than those in the propofol group ((6/39 vs. 17/38, P = 0.005), (2/39 vs. 9/38, P = 0.026), respectively). The number of supplemental doses after successful induction in the RT group was greater than that in the propofol group (4/9/11/13/1/1 vs. 8/4/18/6/2/0 requiring 0, 1, 2, 3, 4 or 5 supplemental doses, P = 0.014). The characteristics of the patients enrolled, postoperative parameters of the patients, and patients' and physician's satisfaction of the procedure were comparable in the two groups.
CONCLUSIONS


Compared with propofol, RT can be safely and effectively used for gastrointestinal endoscopy sedation in elderly patients, and the incidence of sedation-related adverse reactions, especially haemodynamic events and respiratory depression, is lower. When RT is used, the number of supplemental doses after successful induction may increase slightly.
TRIAL REGISTRATION


Chictr.org.cn ChiCTR2000040498. Retrospectively registered (date of registration: December 1, 2020).",2022,"Haemodynamic events and respiratory depression in the RT group were less frequent than those in the propofol group ((6/39 vs. 17/38, P = 0.005), (2/39 vs. 9/38, P = 0.026), respectively).","['77 patients were analysed', '82 patients aged ≥65\u2009years with an American Society of Anaesthesiologists (ASA) grade I-II and a body mass index (BMI) of 18.0 to 30.0\u2009kg/m 2  who were scheduled for gastrointestinal endoscopy from Jan 2021 to Aug 2021', 'elderly patients']","['propofol, RT', 'propofol', 'benzodiazepine', 'RT and propofol', 'propofol 1.5\u2009mg/kg with supplemental doses of 0.5\u2009mg/kg', 'Alfentanil', 'Remimazolam tosilate']","['injection pain', 'Sedation-related side effects, such as injection pain, haemodynamic events and respiratory depression', 'time to LOC (MOAA/S score', ""modified observational alertness/sedation assessment (MOAA/S) score and the patients' body movements"", 'number of supplemental doses after successful induction', 'Haemodynamic events and respiratory depression', 'time to loss of consciousness (LOC) (MOAA/S score\u2009≤\u20091), successful sedation in one dose, number of supplemental doses after successful induction, and recovery time', 'success rate of sedation', 'Postoperative nausea and vomiting (PONV), visual analogue scale (VAS) scores at rest, remedial analgesics, and dizziness or headache']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0079278', 'cui_str': 'Gastrointestinal tract endoscopy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}]","[{'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234425', 'cui_str': 'Level of consciousness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",82.0,0.00629605,"Haemodynamic events and respiratory depression in the RT group were less frequent than those in the propofol group ((6/39 vs. 17/38, P = 0.005), (2/39 vs. 9/38, P = 0.026), respectively).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Anaesthesiology, The Fourth Affiliated Hospital, Zhejiang University, School of Medicine, Yiwu, 322000, Zhejiang, China.'}, {'ForeName': 'Yitao', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': 'Department of Anaesthesiology, The Fourth Affiliated Hospital, Zhejiang University, School of Medicine, Yiwu, 322000, Zhejiang, China.'}, {'ForeName': 'Xiaojin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics, The Fourth Affiliated Hospital, Zhejiang University, School of Medicine, Yiwu, 322000, Zhejiang, China.'}, {'ForeName': 'Shuangjian', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Anaesthesiology, The Fourth Affiliated Hospital, Zhejiang University, School of Medicine, Yiwu, 322000, Zhejiang, China.'}, {'ForeName': 'Qinye', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Anaesthesiology, The Fourth Affiliated Hospital, Zhejiang University, School of Medicine, Yiwu, 322000, Zhejiang, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Anaesthesiology, The Fourth Affiliated Hospital, Zhejiang University, School of Medicine, Yiwu, 322000, Zhejiang, China. 1197058@zju.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-022-01713-6']
1631,35689191,"Impact of the 'Healthy Youngsters, Healthy Dads' program on physical activity and other health behaviours: a randomised controlled trial involving fathers and their preschool-aged children.","BACKGROUND


Targeting fathers may be a key strategy to increase physical activity among their preschool-aged children, but limited research exists in this area. The primary study aim was to examine the impact of a lifestyle program for fathers and their preschool-aged children on child physical activity levels.
METHODS


A total of 125 fathers (aged: 38 ± 5.4 years, BMI: 28.1 ± 4.9 kg/m 2 ) and 125 preschool-aged children (aged: 3.9 ± 0.8 years, BMI z-score: 0.3 ± 0.9, 39.2% girls) recruited from Newcastle, Australia, NSW were randomised to (i) the Healthy Youngsters, Healthy Dads (HYHD) program, or (ii) wait-list control group. The program included two fathers-only workshops (2 h each) and eight father-child weekly educational and practical sessions (75 min each), plus home-based activities targeting family physical activity and nutrition. Assessments took place at baseline, 10-weeks (post-intervention) and 9-months follow-up. The primary outcome was the children's mean steps/day at 10-weeks. Secondary outcomes included: co-physical activity, fathers' physical activity levels and parenting practices for physical activity and screen time behaviours, children's fundamental movement skill (FMS) proficiency, plus accelerometer based light physical activity (LPA) and moderate-to-vigorous physical activity (MVPA), screen time and adiposity for fathers and children. Process measures included; attendance, satisfaction, fidelity and retention. Linear mixed models estimated the treatment effect at all time-points for all outcomes.
RESULTS


Intention-to-treat analyses revealed a significant group-by-time effect for steps per day at 10-weeks (+ 1417, 95%CI: 449, 2384) and 9-months follow-up (+ 1480, 95%CI: 493, 2467) in intervention children compared to control. There were also favourable group-by-time effects for numerous secondary outcomes including fathers' physical activity levels, children's FMS proficiency, and several parenting constructs. No effects were observed for both fathers' and children's accelerometer based LPA or MVPA, co-physical activity, screen-time and adiposity measures. Process evaluation data revealed very high levels of satisfaction, attendance, retention, and intervention fidelity.
CONCLUSION


Engaging fathers in a lifestyle program is a promising strategy to increase physical activity among preschool-aged children. Additional benefits to fathers' physical activity levels, children's FMS proficiency and parenting practices further support the importance of engaging fathers to improve family health outcomes.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry: ACTRN12619000105145 . Registered 24/01/2019.",2022,"No effects were observed for both fathers' and children's accelerometer based LPA or MVPA, co-physical activity, screen-time and adiposity measures.","[""Healthy Youngsters, Healthy Dads' program on physical activity and other health behaviours"", 'fathers and their preschool-aged children', 'preschool-aged children', '125 fathers (aged: 38\u2009±\u20095.4\xa0years, BMI: 28.1\u2009±\u20094.9\xa0kg/m 2 ) and 125 preschool-aged children (aged: 3.9\u2009±\u20090.8\xa0years, BMI z-score: 0.3\u2009±\u20090.9, 39.2% girls) recruited from Newcastle, Australia, NSW', 'fathers and their preschool-aged children on child physical activity levels']","['lifestyle program', 'plus home-based activities targeting family physical activity and nutrition', 'Healthy Youngsters, Healthy Dads (HYHD) program, or (ii) wait-list control group']","[""children's mean steps/day at 10-weeks"", ""fathers' and children's accelerometer based LPA or MVPA, co-physical activity, screen-time and adiposity measures"", ""fathers' physical activity levels, children's FMS proficiency, and several parenting constructs"", 'satisfaction, attendance, retention, and intervention fidelity', 'physical activity', "" co-physical activity, fathers' physical activity levels and parenting practices for physical activity and screen time behaviours, children's fundamental movement skill (FMS) proficiency, plus accelerometer based light physical activity (LPA) and moderate-to-vigorous physical activity (MVPA), screen time and adiposity for fathers and children"", ' attendance, satisfaction, fidelity and retention']","[{'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027983', 'cui_str': 'Newcastle disease'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015670', 'cui_str': 'Father-Child Relationship'}]",,0.0506176,"No effects were observed for both fathers' and children's accelerometer based LPA or MVPA, co-physical activity, screen-time and adiposity measures.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'School of Education, College of Human and Social Futures, University of Newcastle, Callaghan, NSW, 2308, Australia. philip.morgan@newcastle.edu.au.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Grounds', 'Affiliation': 'School of Education, College of Human and Social Futures, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ashton', 'Affiliation': 'School of Education, College of Human and Social Futures, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'College of Health, Medicine and Wellbeing, School of Health Sciences, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Alyce T', 'Initials': 'AT', 'LastName': 'Barnes', 'Affiliation': 'School of Education, College of Human and Social Futures, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Pollock', 'Affiliation': 'School of Education, College of Human and Social Futures, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Stevie-Lee', 'Initials': 'SL', 'LastName': 'Kennedy', 'Affiliation': 'School of Education, College of Human and Social Futures, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Rayward', 'Affiliation': 'School of Education, College of Human and Social Futures, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Saunders', 'Affiliation': 'School of Education, College of Human and Social Futures, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Drew', 'Affiliation': 'Active Living Research Program, Hunter Medical Research Institute, New Lambton Heights, NSW, 2305, Australia.'}, {'ForeName': 'Myles D', 'Initials': 'MD', 'LastName': 'Young', 'Affiliation': 'Active Living Research Program, Hunter Medical Research Institute, New Lambton Heights, NSW, 2305, Australia.'}]",BMC public health,['10.1186/s12889-022-13424-1']
1632,35690665,Circulating nitrate-nitrite reduces oxygen uptake for improving resistance exercise performance after rest time in well-trained CrossFit athletes.,"This study aimed to determine the effects of circulating nitrate plus nitrite (NOx) concentrations on resistance exercise performance, VO 2  and biomarkers of muscle damage. Eleven well-trained male CrossFit athletes (29.2 ± 3.7 years, 78.9 ± 5.4 kg, 175.1 ± 6.3 cm) carried out a resistance exercise test after drinking 140 mL of beetroot juice (BJ) or placebo. The test consisted of repeating the same resistance exercise routine twice: wall ball shots plus full back squat with 3-min rest (1st routine) or without rest (2nd routine) between the two exercises. Higher NO x  plasma levels were verified after BJ than placebo in the pretest and post-test (p < 0.001). A higher number of repetitions was observed after BJ intake compared to placebo in the full back squat exercise during the first routine (p = 0.004). A significantly reduced VO 2  was detected after BJ intake compared to placebo during rest and full back squat execution in the first routine (p < 0.05). Plasma myoglobin concentrations were significantly increased with BJ compared to placebo (p = 0.036). These results showed that plasma NOx levels reduced VO 2  after BJ intake during rest time. These reduced VO 2  was a key factor for improving full back squat performance during the first routine.",2022,A significantly reduced VO 2  was detected after BJ intake compared to placebo during rest and full back squat execution in the first routine (p < 0.05).,"['Eleven well-trained male CrossFit athletes (29.2\u2009±\u20093.7\xa0years, 78.9\u2009±\u20095.4\xa0kg, 175.1\u2009±\u20096.3\xa0cm) carried out a', 'well-trained CrossFit athletes']","['Circulating nitrate-nitrite', 'circulating nitrate plus nitrite (NOx', 'resistance exercise test after drinking 140\xa0mL of beetroot juice (BJ) or placebo', 'resistance exercise routine twice: wall ball shots plus full back squat with 3-min rest (1st routine) or without rest (2nd routine) between the two exercises', 'placebo']","['Higher NO x  plasma levels', 'full back squat performance', 'resistance exercise performance', 'plasma NOx levels', 'Plasma myoglobin concentrations', 'resistance exercise performance, VO 2  and biomarkers of muscle damage']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}]",,0.10246,A significantly reduced VO 2  was detected after BJ intake compared to placebo during rest and full back squat execution in the first routine (p < 0.05).,"[{'ForeName': 'Manuel Vicente', 'Initials': 'MV', 'LastName': 'Garnacho-Castaño', 'Affiliation': 'Campus Docent Sant Joan de Déu, Universidad de Barcelona, Carrer de Miret I Sans, 10, 08034, Barcelona, Spain. manuelvicente.garnacho@sjd.edu.es.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sánchez-Nuño', 'Affiliation': 'Campus Docent Sant Joan de Déu, Universidad de Barcelona, Carrer de Miret I Sans, 10, 08034, Barcelona, Spain.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Molina-Raya', 'Affiliation': 'Campus Docent Sant Joan de Déu, Universidad de Barcelona, Carrer de Miret I Sans, 10, 08034, Barcelona, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Carbonell', 'Affiliation': 'Department of Cell Biology, Physiology and Immunology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Maté-Muñoz', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Eulogio', 'Initials': 'E', 'LastName': 'Pleguezuelos-Cobo', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Hospital de Mataró, Mataró, Barcelona, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Serra-Payá', 'Affiliation': 'School of Health Sciences, TecnoCampus-Pompeu Fabra University, Mataró, Barcelona, Spain.'}]",Scientific reports,['10.1038/s41598-022-13786-x']
1633,35690655,"Blood gas levels, cardiovascular strain and cognitive performance during surgical mask and filtering face piece application.","Mask induced airway resistance and carbon dioxide rebreathing is discussed to impact gas exchange and to induce discomfort and impairments in cognitive performance. N = 23 healthy humans (13 females, 10 males; 23.5 ± 2.1 years) participated in this randomized crossover trial (3 arms, 48-h washout periods). During interventions participants wore either a surgical face mask (SM), a filtering face piece (FFP2) or no mask (NM). Interventions included a 20-min siting period and 20 min steady state cycling on an ergometer at 77% of the maximal heart rate (HR). Hemodynamic data (HR, blood pressure), metabolic outcomes (pulse derived oxygen saturation, capillary carbon dioxide (pCO 2 ), and oxygen partial pressure (pO 2 ), lactate, pH, base excess), subjective response (ability to concentrate, arousal, perceived exertion) and cognitive performance (Stroop Test) were assessed. Compared to NM, both masks increased pCO 2  (NM 31.9 ± 3.3 mmHg, SM = 35.2 ± 4.0 mmHg, FFP2 = 34.5 ± 3.8 mmHg, F = 12.670, p < 0.001) and decreased pH (NM = 7.42 ± 0.03, SM = 7.39 ± 0.03, FFP2 = 7.39 ± 0.04, F = 11.4, p < 0.001) during exercise. The FFP2 increased blood pressure during exercise (NM = 158 ± 15 mmHg, SM = 159 ± 16 mmHg, FFP2 = 162 ± 17 mmHg, F = 3.21, p = 0.050), the SM increased HR during sitting (NM = 70 ± 8 bpm, SM = 74 ± 8 bpm, FFP2 = 73 ± 8 bpm, F = 4.70, p = 0.014). No mask showed any comparative effect on other hemodynamic, metabolic, subjective, or cognitive outcomes. Mask wearing leads to slightly increased cardiovascular stress and elevated carbon dioxide levels during exercise but did not affect cognitive performance or wellbeing.",2022,Mask wearing leads to slightly increased cardiovascular stress and elevated carbon dioxide levels during exercise but did not affect cognitive performance or wellbeing.,"['N\u2009=\u200923 healthy humans (13 females, 10 males; 23.5\u2009±\u20092.1\xa0years']","['surgical face mask (SM), a filtering face piece (FFP2) or no mask (NM', '20-min siting period and 20\xa0min steady state cycling', 'carbon dioxide rebreathing']","['Blood gas levels, cardiovascular strain and cognitive performance', 'SM increased HR', 'cognitive performance or wellbeing', 'cardiovascular stress and elevated carbon dioxide levels', 'hemodynamic, metabolic, subjective, or cognitive outcomes', 'blood pressure', 'Hemodynamic data (HR, blood pressure), metabolic outcomes (pulse derived oxygen saturation, capillary carbon dioxide (pCO 2 ), and oxygen partial pressure (pO 2 ), lactate, pH, base excess), subjective response (ability to concentrate, arousal, perceived exertion) and cognitive performance\xa0(Stroop Test']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0201985', 'cui_str': 'Delta base, blood'}, {'cui': 'C0424098', 'cui_str': 'Ability to concentrate'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]",23.0,0.0329987,Mask wearing leads to slightly increased cardiovascular stress and elevated carbon dioxide levels during exercise but did not affect cognitive performance or wellbeing.,"[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Grimm', 'Affiliation': 'Division Health and Performance, Institute of Occupational, Social and Environmental Medicine, Goethe University Frankfurt, Theodor-Stern-Kai 7, Building 9B, 60590, Frankfurt am Main, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Nienhaus', 'Affiliation': 'Institute for Health Service Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Groneberg', 'Affiliation': 'Institute of Occupational, Social and Environmental Medicine, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Engeroff', 'Affiliation': 'Division Health and Performance, Institute of Occupational, Social and Environmental Medicine, Goethe University Frankfurt, Theodor-Stern-Kai 7, Building 9B, 60590, Frankfurt am Main, Germany. engeroff@sport.uni-frankfurt.de.'}]",Scientific reports,['10.1038/s41598-022-13711-2']
1634,34890563,Determining the Interrater Reliability of the SOFMER Activity Score (version 2) for Individuals in Rehabilitation Centers.,"OBJECTIVE


To assess the interrater reliability of the SOFMER Activity Score (SAS) (version 2 [v2], an 8-item [4 motor and 4 cognitive] and 5-level scale) and improve its scoring system before conducting further validation steps.
DESIGN


Cross-sectional, prospective, observational, noninterventional, and multicentric study.
SETTING


The study was conducted between November 2018 and September 2019 in 4 French rehabilitation centers (2 public university hospitals for adults and 2 private not-for-profit rehabilitation centers for children).
PARTICIPANTS


The study included 101 participants (N=101; mean age, 44.5±25.4 years; 28.7% younger than 18 and 18.8% older than 65 years). The female/male sex ratio was 0.6. The causes for admission to the center were mainly neurologic (65%) or orthopedic (24%).
INTERVENTIONS


None.
MAIN OUTCOME MEASURES


Activity limitation was rated with the SAS the same day by 2 independent multidisciplinary teams. The interrater reliabilities of the score items were assessed using weighted kappa coefficients.
RESULTS


All weighted kappa coefficients ranged between 0.83 and 0.92, indicating ""good"" to ""excellent"" interrater reliability. Interteam score disagreements occurred in 227 of 808 scores (28%). The reason for most disagreements was unnoticed human or material aid during the observation period.
CONCLUSIONS


The results demonstrate the high interrater reliability of the SASv2 and allow carrying out further validation steps after minor changes to item scoring instructions and clearer definitions of some items that help improving scoring standardization. The SASv2 may then become a consistent measure of activity level for clinical research or burden of care investigations.",2022,The results demonstrate the high interrater reliability of the SASv2 and allow carrying out further validation steps after minor changes to item scoring instructions and clearer definitions of some items that help improving scoring standardization.,"['The study was conducted between November 2018 and September 2019 in 4 French rehabilitation centers (2 public university hospitals for adults and 2 private not-for-profit rehabilitation centers for children', 'The study included 101 participants (N=101; mean age, 44.5±25.4 years; 28.7% younger than 18 and 18.8% older than 65 years']",[],"['Interrater Reliability of the SOFMER Activity Score', 'interrater reliability of the SOFMER Activity Score (SAS) (version 2 [v2], an 8-item [4 motor and 4 cognitive] and 5-level scale', 'Interteam score disagreements']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",101.0,0.0647126,The results demonstrate the high interrater reliability of the SASv2 and allow carrying out further validation steps after minor changes to item scoring instructions and clearer definitions of some items that help improving scoring standardization.,"[{'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Charvolin', 'Affiliation': ""Service de Médecine Physique et de Réadaptation Pédiatrique (L'Escale), Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, Bron. Electronic address: lorraine.charvolin@gmail.com.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Rippert', 'Affiliation': 'Service Recherche et Épidémiologie Clinique, Pôle Santé Publique, Hospices Civils de Lyon, Lyon.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Roche', 'Affiliation': 'Université de Lyon, Lyon; Université Lyon 1, Villeurbanne; Service de Biostatistique-Bioinformatique, Hospices Civils de Lyon, Pôle Santé Publique, Lyon; Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Rabilloud', 'Affiliation': 'Université de Lyon, Lyon; Université Lyon 1, Villeurbanne; Service de Biostatistique-Bioinformatique, Hospices Civils de Lyon, Pôle Santé Publique, Lyon; Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne.'}, {'ForeName': 'Marie-Doriane', 'Initials': 'MD', 'LastName': 'Morard', 'Affiliation': ""Service de Médecine Physique et de Réadaptation Pédiatrique (L'Escale), Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, Bron.""}, {'ForeName': 'Julie Di', 'Initials': 'JD', 'LastName': 'Marco', 'Affiliation': 'Service de Médecine Physique et Réadaptation, Hôpital Henry-Gabrielle, Hospices Civils de Lyon, Saint-Genis-Laval.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Dinomais', 'Affiliation': 'Département de Médecine Physique et Rééducation, Centre Hospitalier Universitaire, Angers.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Pouyfaucon', 'Affiliation': ""Service Médecine Physique et Rééducation Fonctionnelle, Centre Hospitalier Universitaire d'Angers, Angers; Centre de Rééducation et de Réadaptation Fonctionnelles Les Capucins, Angers; Service de Rééducation, Centre Hospitaliser de Cholet, Cholet.""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Gimat', 'Affiliation': 'Service Rééducation Neurologique, Hôpital Sud Centre Hospitalier Universitaire de Grenoble-Alpes, Echirolles; Laboratoire de Psychologie et Neurocognition (LPNC), Université Grenoble-Alpes, Grenoble.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Perennou', 'Affiliation': 'Service Rééducation Neurologique, Hôpital Sud Centre Hospitalier Universitaire de Grenoble-Alpes, Echirolles; Laboratoire de Psychologie et Neurocognition (LPNC), Université Grenoble-Alpes, Grenoble.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Houx', 'Affiliation': ""Service de Médecine Physique et de Réadaptation, Centre Hospitalier Régional et Universitaire de Brest, Brest; Laboratoire de Traitement de l'Information Médicale (LaTIM), Brest; Service de Médecine Physique et de Réadaptation Pédiatrique, Fondation Ildys, Brest.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Iwaz', 'Affiliation': 'Université de Lyon, Lyon; Université Lyon 1, Villeurbanne; Service de Biostatistique-Bioinformatique, Hospices Civils de Lyon, Pôle Santé Publique, Lyon; Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Rode', 'Affiliation': 'Université de Lyon, Lyon; Service de Médecine Physique et Réadaptation, Hôpital Henry-Gabrielle, Hospices Civils de Lyon, Saint-Genis-Laval; Integrative, Multisensory, Perception, Action, and Cognition Team (IMPACT), Centre de Recherche en Neurosciences de Lyon, Université Saint-Etienne, Bron.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Vuillerot', 'Affiliation': ""Service de Médecine Physique et de Réadaptation Pédiatrique (L'Escale), Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, Bron; Université de Lyon, Lyon; Institut Neuromyogène, Lyon, France.""}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.11.005']
1635,35691103,Prospective examination of psychological risk and maintenance factors for body image distress after mastectomy with immediate breast reconstruction.,"Reconstructive breast surgery aims to improve body image following mastectomy, yet many women experience ongoing body image distress (BID). The relationship between the esthetic outcome of reconstructive surgery with BID has been underexplored in mastectomy. This study aimed to assess whether reconstruction outcome following mastectomy is associated with post-surgery BID, and to examine potential psychological risk and maintenance factors for BID above reconstruction outcome. In 49 women undergoing mastectomy with immediate breast reconstruction, we prospectively assessed hypothesized pre-surgery psychological risk factors and post-surgery maintenance factors for post-surgery BID. Reconstruction outcome was assessed via blind surgeon ratings of post-surgery photographs. Surgeon-rated reconstruction outcome was uncorrelated with BID, or with patients' ratings of surgical outcome. Higher pre-surgery depressive symptoms and lower pre-surgery patient expectations for reconstruction predicted greater post-surgery BID, above reconstruction outcome. Post-surgery body checking also predicted greater BID, above reconstruction outcome. Results suggest that the medical team cannot assume their perception of reconstruction outcome matches the patient's view or degree of BID. If replicated, results point to potential psychological risk and maintenance factors that are stronger predictors of post-reconstruction BID, highlighting opportunities for light-touch prevention and intervention to reduce BID after mastectomy with breast reconstruction.",2022,"Surgeon-rated reconstruction outcome was uncorrelated with BID, or with patients' ratings of surgical outcome.","['body image distress after mastectomy with immediate breast reconstruction', '49 women undergoing mastectomy with immediate breast reconstruction']",['Reconstructive breast surgery'],[],"[{'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}]",[],49.0,0.104798,"Surgeon-rated reconstruction outcome was uncorrelated with BID, or with patients' ratings of surgical outcome.","[{'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Weingarden', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge St., Suite 2000, Boston, MA 02114, United States. Electronic address: hilary_weingarden@mgh.harvard.edu.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge St., Suite 2000, Boston, MA 02114, United States. Electronic address: swilhelm@mgh.harvard.edu.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St., Boston, MA 02114, United States. Electronic address: jjacobs@mgh.harvard.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Carrellas', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge St., Suite 2000, Boston, MA 02114, United States. Electronic address: jcarrellas@mgh.harvard.edu.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Cetrulo', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St., Boston, MA 02114, United States. Electronic address: ccetrulo@mgh.harvard.edu.'}, {'ForeName': 'William Gerald', 'Initials': 'WG', 'LastName': 'Austen', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St., Boston, MA 02114, United States. Electronic address: wausten@mgh.harvard.edu.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Colwell', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St., Boston, MA 02114, United States. Electronic address: acolwell@mgh.harvard.edu.'}]",Body image,['10.1016/j.bodyim.2022.05.014']
1636,35691087,Spatial and neighborhood-level correlates of lay naloxone reversal events and service availability.,"BACKGROUND


The opioid epidemic in the United States continues to surge, reaching record deaths from opioid and fentanyl overdoses in 2020. This study analyzes spatial and neighborhood correlates of free naloxone distribution sites as well as overdose and naloxone reversal events in Baltimore, Maryland, which has one of the highest overdose rates in the country.
METHODS


Using data from a randomized clinical trial on HIV prevention among people using substances in Baltimore, Maryland, as well as demographic data from the US Census Bureau, we conducted: (1) exploratory spatial visualizations of census tracts' minimum distance to naloxone distribution sites, (2) univariable Wilcoxon rank-sum tests to compare census tracts on demographic metrics, and (3) bivariable and multivariable negative binomial regression models to assess associations between census tract characteristics and naloxone reversal events.
RESULTS


Valid geographic data were provided for 518 overdose events involving either fentanyl or heroin in this study. Of these, 190 (37%) attempted naloxone reversal events were reported. Exploratory spatial visualization techniques suggest that most distribution sites are appropriately located near populations at high risk of overdose, but study findings also identify areas where drug use and overdoses occur that are located farther from distribution sites. In multivariable analyses, naloxone administration was significantly and inversely associated with distance to the nearest distribution site (incidence rate ratio (IRR)=0.72 per 1000m increase, 95% CI 0.59-0.89, p=0.002).
CONCLUSION


Study findings emphasize the correlation between proximity to naloxone sites and utilization of resources, highlighting that physical proximity to harm reduction resources may contribute to uptake. Results further underscore that research on service accessibility and utilization must consider the spatial distribution of health services.",2022,"In multivariable analyses, naloxone administration was significantly and inversely associated with distance to the nearest distribution site (incidence rate ratio (IRR)=0.72 per 1000m increase, 95% CI 0.59-0.89, p=0.002).
","[""people using substances in Baltimore, Maryland, as well as demographic data from the US Census Bureau, we conducted: (1) exploratory spatial visualizations of census tracts' minimum distance to naloxone distribution sites""]","['naloxone', 'fentanyl or heroin']","['distance to the nearest distribution site (incidence rate ratio', 'naloxone reversal events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1829462', 'cui_str': 'Using substance'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}, {'cui': 'C0007663', 'cui_str': 'Census'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.177415,"In multivariable analyses, naloxone administration was significantly and inversely associated with distance to the nearest distribution site (incidence rate ratio (IRR)=0.72 per 1000m increase, 95% CI 0.59-0.89, p=0.002).
","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Yi', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; David Geffen School of Medicine, University of California, Los Angeles, 10833 Le Conte Ave., Los Angeles, CA 90025. Electronic address: gyi1@jhu.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Dayton', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Mudia', 'Initials': 'M', 'LastName': 'Uzzi', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Browne', 'Affiliation': 'Luskin School of Public Policy, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Konstantopoulos', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",The International journal on drug policy,['10.1016/j.drugpo.2022.103739']
1637,35691053,Transcutaneous electric nerve stimulation in chronic subjective tinnitus.,"OBJECTIVE


It is aimed to determine the therapeutic role of transcutaneous electrical nerve stimulation (TENS) on chronic subjective tinnitus with a randomized and comparative analysis.
METHOD


46 individuals with normal hearing, chronic subjective tinnitus, aged 20-65; randomly divided into the study (TENS therapy) and tje control groups. The control group (n = 23) was informed only about tinnitus, while the study group (n = 23) received TENS therapy (20 sessions in 4 weeks). Before TENS therapy, tinnitus-related evaluations of all participants [tinnitus frequency, loudness, minimum masking level (MMS), residual inhibition (RI)] were made and Tinnitus Handicap Inventory (THI), Visual Analogue Scale (VAS), Short Form 36 (SF-36), and The Quality of Life Scale were applied to the participants. These evaluations and questionnaires were repeated after 4 weeks of the therapy.
RESULTS


There was a significant decrease in the tinnitus severity after TENS therapy in the study group (p = 0.003). Moreover, it was found that VAS (loudness and annoyance), THI (functional, emotional and total score), SF-36 (physical function, physical role, pain, general health, vitality, emotional role and social function) values improved compared to before TENS therapy and the difference was significant (p < 0.05). There was no significant difference between the first and last evaluations of the control group (p > 0.05).
CONCLUSION


TENS is an effective, practical and reliable therapy method in reducing severity, loudness, and annoyance of tinnitus, and increasing the quality of life in individuals with chronic subjective tinnitus.",2022,There was a significant decrease in the tinnitus severity after TENS therapy in the study group (p = 0.003).,"['46 individuals with normal hearing, chronic subjective tinnitus, aged 20-65; randomly divided into the study (TENS therapy) and tje control groups', 'individuals with chronic subjective tinnitus', 'chronic subjective tinnitus']","['transcutaneous electrical nerve stimulation (TENS', 'TENS', 'Transcutaneous electric nerve stimulation', 'TENS therapy']","['severity, loudness, and annoyance of tinnitus', 'quality of life', 'chronic subjective tinnitus', 'VAS (loudness and annoyance), THI (functional, emotional and total score), SF-36 (physical function, physical role, pain, general health, vitality, emotional role and social function) values', 'tinnitus severity', 'tinnitus frequency, loudness, minimum masking level (MMS), residual inhibition (RI)] were made and Tinnitus Handicap Inventory (THI), Visual Analogue Scale (VAS), Short Form 36 (SF-36), and The Quality of Life Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0234725', 'cui_str': 'Hearing normal'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0155533', 'cui_str': 'Subjective tinnitus'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0155533', 'cui_str': 'Subjective tinnitus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",46.0,0.0111713,There was a significant decrease in the tinnitus severity after TENS therapy in the study group (p = 0.003).,"[{'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Aydogan', 'Affiliation': 'Department of Audiology, Faculty of Health Sciences, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Cinar Satekin', 'Affiliation': 'Ankara University, Faculty of Medicine, Otolaryngology Department, Audiology, Speech, Balance Disorders Diagnosis and Rehabilitation Unit, Ankara, Turkey.'}, {'ForeName': 'Muhammed Sefa', 'Initials': 'MS', 'LastName': 'Uyar', 'Affiliation': 'Ankara University, Faculty of Medicine, Otolaryngology Department, Ankara, Turkey.'}, {'ForeName': 'Suna Tokgoz', 'Initials': 'ST', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Audiology, Faculty of Health Sciences, Ankara University, Ankara, Turkey; Ankara University, Faculty of Medicine, Otolaryngology Department, Audiology, Speech, Balance Disorders Diagnosis and Rehabilitation Unit, Ankara, Turkey. Electronic address: sunatokgoz@yahoo.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2022.103521']
1638,35691323,"Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial.","BACKGROUND


Active-comparator trials are important to inform patient and physician choice. We aimed to evaluate the efficacy and safety of monotherapy with either ustekinumab or adalimumab in biologic-naive patients with moderately to severely active Crohn's disease.
METHODS


We conducted a randomised, double-blind, parallel-group, active-comparator, phase 3b trial (SEAVUE) at 121 hospitals or private practices in 18 countries. We included biologic-naive patients aged 18 years or older with moderately to severely active Crohn's disease and a Crohn's Disease Activity Index (CDAI) score of 220-450, who had not responded to or were intolerant to conventional therapy (or were corticosteroid dependent) and had at least one ulcer of any size at baseline endoscopic evaluation. Eligible patients were randomly assigned (1:1; via an interactive web response system) to receive ustekinumab (approximately 6 mg/kg intravenously on day 0, then 90 mg subcutaneously once every 8 weeks) or adalimumab (160 mg on day 0, 80 mg at 2 weeks, then 40 mg once every 2 weeks, subcutaneously) through week 56. Study treatments were administered as monotherapy and without dose modifications. Patients, investigators, and study site personnel were masked to treatment group assignment. The primary endpoint was the proportion of patients who were in clinical remission (CDAI score <150) at week 52 in the intention-to-treat population (ie, all patients who were randomly assigned to a treatment group). This trial is registered with ClinicalTrials.gov, NCT03464136, and EudraCT, 2017-004209-41.
FINDINGS


Between June 28, 2018, and Dec 12, 2019, 633 patients were assessed for eligibility and 386 were enrolled and randomly assigned to receive ustekinumab (n=191) or adalimumab (n=195). 29 (15%) of 191 patients in the ustekinumab group and 46 (24%) of 195 in the adalimumab group discontinued study treatment before week 52. There was no significant difference between the ustekinumab and adalimumab groups in the occurrence of the primary endpoint; at week 52, 124 (65%) of 191 patients in the ustekinumab group versus 119 (61%) of 195 in the adalimumab group were in clinical remission (between-group difference 4%, 95% CI -6 to 14; p=0·42). Safety for both groups was consistent with previous reports. Serious infections were reported in four (2%) of 191 patients in the ustekinumab group and five (3%) of 195 in the adalimumab group. No deaths occurred through week 52 of the study.
INTERPRETATION


Both ustekinumab and adalimumab monotherapies were highly effective in this population of biologic-naive patients, with no difference in the primary outcome between the drugs.
FUNDING


Janssen Scientific Affairs.",2022,"There was no significant difference between the ustekinumab and adalimumab groups in the occurrence of the primary endpoint; at week 52, 124 (65%) of 191 patients in the ustekinumab group versus 119 (61%) of 195 in the adalimumab group were in clinical remission (between-group difference 4%, 95% CI -6 to 14; p=0·42).","['121 hospitals or private practices in 18 countries', 'Eligible patients', ""biologic-naive patients with moderately to severely active Crohn's disease"", ""patients aged 18 years or older with moderately to severely active Crohn's disease and a Crohn's Disease Activity Index (CDAI) score of 220-450, who had not responded to or were intolerant to conventional therapy (or were corticosteroid dependent) and had at least one ulcer of any size at baseline endoscopic evaluation"", 'Between June 28, 2018, and Dec 12, 2019, 633 patients were assessed for eligibility and 386 were enrolled']","['ustekinumab', 'Ustekinumab versus adalimumab', 'ustekinumab or adalimumab', 'adalimumab']","['efficacy and safety', 'clinical remission', 'proportion of patients who were in clinical remission (CDAI score', 'deaths', 'Serious infections']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",633.0,0.654544,"There was no significant difference between the ustekinumab and adalimumab groups in the occurrence of the primary endpoint; at week 52, 124 (65%) of 191 patients in the ustekinumab group versus 119 (61%) of 195 in the adalimumab group were in clinical remission (between-group difference 4%, 95% CI -6 to 14; p=0·42).","[{'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: bruce.sands@mssm.edu.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Irving', 'Affiliation': ""Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, UK; School of Immunology and Microbial Sciences, King's College London, London, UK.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hoops', 'Affiliation': 'Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Izanec', 'Affiliation': 'Janssen Scientific Affairs, Horsham, PA, USA.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Gao', 'Affiliation': 'Janssen Scientific Affairs, Horsham, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gasink', 'Affiliation': 'Janssen Scientific Affairs, Horsham, PA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Greenspan', 'Affiliation': 'Janssen Scientific Affairs, Horsham, PA, USA.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Allez', 'Affiliation': 'Gastroenterology Department, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris (AP-HP), INSERM U1160, Université de Paris, Paris, France.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Hanauer', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University Hospital, London, ON, Canada; Division of Epidemiology and Biostatistics, Western University, London, ON, Canada.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Kuehbacher', 'Affiliation': 'Department of Internal Medicine, Gastroenterology, Diabetology, Hemato-Oncology, and Palliative Medicine, Medius Clinic Nuertingen, Nürtingen, Germany.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Lewis', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Loftus', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Mihaly', 'Affiliation': 'Department of Internal Medicine and Hematology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Scherl', 'Affiliation': 'Weill Department of Medicine, New York Presbyterian Hospital Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Oksana B', 'Initials': 'OB', 'LastName': 'Shchukina', 'Affiliation': 'Division The City Center for IBD Diagnosis and Treatment, Saint Petersburg State Budgetary Health Institution, City Clinical Hospital 31, Saint Petersburg, Russia.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(22)00688-2']
1639,35694708,Efficacy of Self-Made  Hewei  Decoction for Chronic Atrophic Gastritis and Its Effect on Gastrin and Pepsinogen Expression Levels.,"We aim to investigate the therapeutic effect of self-made  Hewei  decoction based on the differences-in-differences (DID) model for treating chronic atrophic gastritis and its effect on the gastrin and pepsinogen expression. A total of 166 chronic atrophic gastritis patients treated in our hospital from January 2019 to September 2020 were recruited and randomly assigned to a treatment group and a control group ( n  = 83 per group). In the control group, patients were given conventional western medicine. In the treatment group, patients were administered self-made  Hewei  decoction besides conventional western medicine. The general data, total effective rate, and histological changes before and after treatment were compared between the two groups. The DID model was utilized to compare the changes in three items of gastric function and traditional Chinese medicine (TCM) syndrome scores at various time points (before treatment and 1, 3, 6, and 12 months after treatment) between the two groups. In the treatment group, 5 cases were lost to follow-up, and 78 cases remained. In the control group, 4 cases were lost to follow-up, and 79 cases remained. The total effective rate in the treatment group (93.59%) was significantly higher than that in the control group (82.28%) ( P  < 0.05). The histological score was not significantly different between the two groups before treatment ( P  > 0.05). The histological score at 12 months after treatment was lower than those before treatment in the two groups ( P  < 0.05). The histological score was lower in the treatment group than that in the control group ( P  < 0.05). After treatment, the TCM syndrome score and PGR17 level were lower in the treatment group than those in the control group at each time point ( P  < 0.05). PGI and PGII levels were higher in the treatment group than those in the control group at each time point ( P  < 0.05). DID regression model showed that TCM syndrome score and PGR17 level decreased by 106.2% and 65.8%, respectively, after treatment in patients with chronic atrophic gastritis ( P  < 0.05), but the treatment mode was opposite to the overall therapeutic effect in terms of time. The PGI and PGII levels increased by 102.9% and 97.8%, respectively, in patients with chronic atrophic gastritis ( P  < 0.05), and the treatment mode was the same as the overall therapeutic effect in terms of time. There was no significant difference in the therapeutic effect between the two groups at 1 month after treatment. A significant difference in the therapeutic effect was detected between the two groups at 3 months after treatment, and the difference showed a decreasing trend after 6 months after treatment. Self-made  Hewei  decoction can improve the histological alterations in chronic atrophic gastritis, relieve clinical symptoms, and ameliorate the expression levels of three items of gastric function.",2022,"After treatment, the TCM syndrome score and PGR17 level were lower in the treatment group than those in the control group at each time point ( P  < 0.05).",['166 chronic atrophic gastritis patients treated in our hospital from January 2019 to September 2020'],"['conventional western medicine', 'self-made  Hewei  decoction', 'Self-Made  Hewei  Decoction', 'Self-made  Hewei  decoction', 'self-made  Hewei  decoction besides conventional western medicine']","['total effective rate', 'gastric function and traditional Chinese medicine (TCM) syndrome scores', 'PGI and PGII levels', 'Chronic Atrophic Gastritis', 'therapeutic effect', 'total effective rate, and histological changes', 'histological score', 'chronic atrophic gastritis', 'Gastrin and Pepsinogen Expression Levels', 'TCM syndrome score and PGR17 level']","[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0017154', 'cui_str': 'Atrophic gastritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232538', 'cui_str': 'Gastric function'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C0523817', 'cui_str': 'Pepsinogen II measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017154', 'cui_str': 'Atrophic gastritis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0030913', 'cui_str': 'Pepsinogen'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",166.0,0.0132666,"After treatment, the TCM syndrome score and PGR17 level were lower in the treatment group than those in the control group at each time point ( P  < 0.05).","[{'ForeName': 'Jianyun', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': ""Department of Traditional Chinese Medicine, Changkou Branch of the First People's Hospital Medical Community of Fuyang District, Hangzhou 311411, Zhejiang Province, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Integrated Traditional Chinese and Western Medicine, First People's Hospital of Fuyang District, Hangzhou 311400, Zhejiang Province, China.""}]",Contrast media & molecular imaging,['10.1155/2022/1092695']
1640,35694706,Quantitative Evaluation of Extramural Vascular Invasion of Rectal Cancer by Dynamic Contrast-Enhanced Magnetic Resonance Imaging.,"This study was carried out to explore the preoperative predictive value of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in extramural vascular invasion (EMVI) in patients with rectal cancer. 124 patients with rectal cancer were randomly divided into two groups, with 62 groups in each group. One group used conventional magnetic resonance imaging (MRI) and was recorded as the control group. The other group used DCE-MRI and was recorded as the experimental group. The diagnostic value was evaluated by comparing the MRI quantitative parameters of EMVI positive and EMVI negative patients, as well as the area under the curve (AUC) of the receiver operating characteristic curve (ROC), diagnostic sensitivity, and specificity of the two groups. The results showed that the Ktrans and Ve values of EMVI positive patients in the experimental group and the control group were 1.08 ± 0.97 and 1.03 ± 0.93, and 0.68 ± 0.29 and 0.65 ± 0.31, respectively, which were significantly higher than those in EMVI negative patients ( P  < 0.05). The AUC of EMVI diagnosis in the experimental group and the control group were 0.732 and 0.534 ( P  < 0.05), the sensitivity was 0.913 and 0.765 ( P  < 0.05), and the specificity was 0.798 and 0.756 ( P  > 0.05), respectively. In conclusion, DCE-MRI has a higher diagnostic value than conventional MRI in predicting EMVI in patients with rectal cancer, which was worthy of further clinical promotion.",2022,"The AUC of EMVI diagnosis in the experimental group and the control group were 0.732 and 0.534 ( P  < 0.05), the sensitivity was 0.913 and 0.765 (","['patients with rectal cancer', '124 patients with rectal cancer']","['Dynamic Contrast-Enhanced Magnetic Resonance Imaging', 'conventional MRI', 'conventional magnetic resonance imaging (MRI', 'dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI']","['sensitivity', 'area under the curve (AUC) of the receiver operating characteristic curve (ROC), diagnostic sensitivity, and specificity', 'AUC of EMVI diagnosis', 'specificity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",124.0,0.0914551,"The AUC of EMVI diagnosis in the experimental group and the control group were 0.732 and 0.534 ( P  < 0.05), the sensitivity was 0.913 and 0.765 (","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, The First Hospital of Changsha, Changsha 410005, Hunan, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, The First Hospital of Changsha, Changsha 410005, Hunan, China.'}, {'ForeName': 'Guannan', 'Initials': 'G', 'LastName': 'Ye', 'Affiliation': 'Department of Gastroenterology, The First Hospital of Changsha, Changsha 410005, Hunan, China.'}, {'ForeName': 'Dayong', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, The First Hospital of Changsha, Changsha 410005, Hunan, China.'}]",Contrast media & molecular imaging,['10.1155/2022/3038308']
1641,35694704,K-Space Data Reconstruction Algorithm-Based MRI Diagnosis and Influencing Factors of Knee Anterior Cruciate Ligament Injury.,"This study was aimed at investigating the diagnostic value of MRI based on K-space data reconstruction algorithm for anterior cruciate ligament (ACL) injury of knee joint and the influencing factors of ligament injury. 96 patients with ACL injury of knee joint were selected, and they were randomly divided into two groups: group A (arthroscopy) and group B (MRI examination), and another 96 healthy volunteers in the same period were selected as the control group. The test results of each indicator were compared. The results showed that the signal-to-noise ratio (SNR) of SMASH algorithm was higher than that of sum of squares (SOS) algorithm. In group A, there were 66 positive and 30 negative tests, and in group B, there were 56 positive and 40 negative tests ( P  < 0.05). The intercondylar fossa width, the intercondylar fossa width index, and the ratio of tibial intercondylar eminence width to intercondylar fossa width in group B were lower than those in the control group ( P  < 0.05). Compared with the traditional SOS algorithm, SMASH algorithm can improve the image quality, reduce the impact of damage data on the final synthesis image, and improve the image SNR. In clinical work, the ratio of the width of tibial intercondylar eminence to the width of femoral intercondylar fossa can be measured by imaging data to evaluate the matching between tibial intercondylar eminence and femoral intercondylar fossa, so as to evaluate the risk of ACL rupture.",2022,"Compared with the traditional SOS algorithm, SMASH algorithm can improve the image quality, reduce the impact of damage data on the final synthesis image, and improve the image SNR.","['96 healthy volunteers in the same period were selected as the control group', 'Knee Anterior Cruciate Ligament Injury', '96 patients with ACL injury of knee joint', 'anterior cruciate ligament (ACL) injury of knee joint']","['K-space data reconstruction algorithm', 'K-Space Data Reconstruction Algorithm-Based MRI Diagnosis', 'group A (arthroscopy) and group B (MRI examination']","['intercondylar fossa width, the intercondylar fossa width index, and the ratio of tibial intercondylar eminence width to intercondylar fossa width', 'signal-to-noise ratio (SNR) of SMASH algorithm']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0325079', 'cui_str': 'Cryptoprocta ferox'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0223894', 'cui_str': 'Structure of intercondylar spine of tibia'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}]",96.0,0.0658005,"Compared with the traditional SOS algorithm, SMASH algorithm can improve the image quality, reduce the impact of damage data on the final synthesis image, and improve the image SNR.","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Chang', 'Affiliation': ""Department of Orthopaedics, The People's Hospital of Wenjiang, Chengdu 611130, Sichuan, China.""}, {'ForeName': 'Angang', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedics, The People's Hospital of Wenjiang, Chengdu 611130, Sichuan, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics, The People's Hospital of Wenjiang, Chengdu 611130, Sichuan, China.""}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Department of Orthopaedics, The People's Hospital of Wenjiang, Chengdu 611130, Sichuan, China.""}, {'ForeName': 'Benqiang', 'Initials': 'B', 'LastName': 'Zeng', 'Affiliation': ""Department of Orthopaedics, The People's Hospital of Wenjiang, Chengdu 611130, Sichuan, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, The People's Hospital of Wenjiang, Chengdu 611130, Sichuan, China.""}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Neurorehabilitation, Affiliated Sichuan Provincial Rehabilitation Hospital of Chengdu University of TCM, Chengdu 611130, Sichuan, China.'}]",Contrast media & molecular imaging,['10.1155/2022/1711456']
1642,35694680,"The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial.","Introduction and Aim


Radial artery approach angiography is the current gold standard for coronary status diagnostics and eventual percutaneous revascularization (PCI). Currently, application of adequate, patent hemostasis based physical torniquets are used for puncture site control, to avoid bleeding, radial artery occlusion and damage (RAO and RAD). The Radial Artery Puncture Hemostasis Evaluation (RAPHE) is a prospective, randomized, multicenter clinical trial designed to investigate new, simplified techniques of radial artery hemostasis utilizing physical compression free methods.
Methods and Results


The RAPHE study has been designed to evaluate the efficacy and safety of two non-compression based radial artery hemostasis methods: a 100% chitosan bioactive hemostatic dressing and a purpose-built radial potassium-ferrate based topical hemostasis disc. These devices will be investigated in a standalone configuration. Control group is a standard pneumatic airbladder-based compression device. A total of 600 patients will be enrolled in a three-way randomization (1:1:1) with two study and one control groups. Safety and efficacy endpoints are RAO, puncture site hematoma formation and RAD respectively, consisting of dissection, (pseudo)aneurism and/or fistula formation, measured post-procedure and at sixty days.
Conclusion


The results from this trial will provide valuable information on new, simplified methods of radial artery hemostasis options and possibly simplify post-puncture management of patients.
Clinical Trial Registration


[www.ClinicalTrials.gov], identifier [NCT04857385].",2022,The RAPHE study has been designed to evaluate the efficacy and safety of two non-compression based radial artery hemostasis methods: a 100% chitosan bioactive hemostatic dressing and a purpose-built radial potassium-ferrate based topical hemostasis disc.,['600 patients will be enrolled in a three-way randomization (1:1:1) with two study and one control groups'],"['standard pneumatic airbladder-based compression device', 'radial artery hemostasis utilizing physical compression free methods']","['pseudo)aneurism and/or fistula formation', 'efficacy and safety', 'Safety and efficacy endpoints are RAO, puncture site hematoma formation and RAD respectively, consisting of dissection, ']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4760962', 'cui_str': 'Puncture site haematoma'}, {'cui': 'C0406775', 'cui_str': 'Symmetrical dyschromatosis of extremities'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]",600.0,0.0657835,The RAPHE study has been designed to evaluate the efficacy and safety of two non-compression based radial artery hemostasis methods: a 100% chitosan bioactive hemostatic dressing and a purpose-built radial potassium-ferrate based topical hemostasis disc.,"[{'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Kulyassa', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Balázs T', 'Initials': 'BT', 'LastName': 'Németh', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Réka', 'Initials': 'R', 'LastName': 'Ehrenberger', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Ruzsa', 'Affiliation': 'Invasive Cardiology Division, Department of Internal Medicine, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Szük', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Fehérvári', 'Affiliation': 'Center for Translational Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Marie Anne', 'Initials': 'MA', 'LastName': 'Engh', 'Affiliation': 'Center for Translational Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Dávid', 'Initials': 'D', 'LastName': 'Becker', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'István F', 'Initials': 'IF', 'LastName': 'Édes', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2022.881266']
1643,35694924,Training with Odors Impacts Hippocampal Thickness in Patients with Mild Cognitive Impairment.,"BACKGROUND


The olfactory system is affected early in Alzheimer's disease and olfactory loss can already be observed in patients with mild cognitive impairment (MCI). Olfactory training is effective for improving olfactory and cognitive function by stimulating the olfactory pathway, but its effect on patients with MCI remains unclear.
OBJECTIVE


The aim of this randomized, prospective, controlled, blinded study was to assess whether a 4-month period of olfactory training (frequent short-term sniffing various odors) may have an effect on olfactory function, cognitive function, and morphology of medial temporal lobe (MTL) subregions and olfactory bulb in MCI patients.
METHODS


A total of thirty-seven MCI patients were randomly assigned to the training group or a placebo group, which were performed twice a day for 4 months. Olfactory assessments, cognitive tests and magnetic resonance imaging were performed at the baseline and follow-up period.
RESULTS


After the training, there was an increase in odor discrimination, and increased cortical thickness of bilateral hippocampus (CA23DG and CA1) and mean MTL. Additionally, the change of olfactory score was positively associated with change of volume of olfactory bulb and hippocampus; the change of global cognition was positively associated with change of cortical thickness of hippocampus, entorhinal cortex and mean MTL; the change of cortical thickness of entorhinal cortex was positively associated with change of executive function.
CONCLUSION


Olfactory training was associated with an increase in cortical thickness of the hippocampus but not olfactory bulb volume in patients with MCI. Olfactory training may serve as an early intervention of preventing hippocampal atrophy.",2022,"CONCLUSION


Olfactory training was associated with an increase in cortical thickness of the hippocampus but not olfactory bulb volume in patients with MCI.","['Patients with Mild Cognitive Impairment', 'MCI patients', 'patients with mild cognitive impairment (MCI', 'A total of thirty-seven MCI patients']","['Olfactory training', 'Training with Odors Impacts Hippocampal Thickness', 'placebo', 'olfactory training (frequent short-term sniffing various odors']","['cortical thickness', 'olfactory function, cognitive function, and morphology of medial temporal lobe (MTL) subregions and olfactory bulb', 'odor discrimination, and increased cortical thickness of bilateral hippocampus (CA23DG and CA1) and mean MTL', 'cortical thickness of hippocampus, entorhinal cortex and mean MTL; the change of cortical thickness of entorhinal cortex', 'change of olfactory score', 'global cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1720573', 'cui_str': 'Sniff'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}, {'cui': 'C0028936', 'cui_str': 'Structure of olfactory bulb'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0694598', 'cui_str': 'CA1 Field of Hippocampus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175196', 'cui_str': 'Structure of entorhinal cortex'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",37.0,0.0372993,"CONCLUSION


Olfactory training was associated with an increase in cortical thickness of the hippocampus but not olfactory bulb volume in patients with MCI.","[{'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Haehner', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Espin', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haussmann', 'Affiliation': 'Department of Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Matthes', 'Affiliation': 'Department of Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Desser', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Loessner', 'Affiliation': 'Department of Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Moritz D', 'Initials': 'MD', 'LastName': 'Brandt', 'Affiliation': 'Department of Neurology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Donix', 'Affiliation': 'Department of Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-220248']
1644,35695362,The Influence of Low and Iso-osmolar Contrast Media on Diagnostic Performance of Contrast Fractional Flow Reserve Measurement.,"OBJECTIVE


For fractional flow reserve measurement, contrast media can be used as an alterna- tive for adenosine. However, contrast media with different physical characteristics (e.g., osmo- lality and viscosity) may have different effects on hyperemia. This study aimed to determine if the diagnostic accuracy of contrast fractional flow reserve was influenced by 2 commonly used contrast media (Visipaque and Ultravist).
METHODS


In this diagnostic study, candidates for coronary angiography with intermediate cor- onary lesion were enrolled and randomized to receive either an iso-osmolar contrast media (Visipaque) or a low osmolar contrast media (Ultravist) for fractional flow reserve measure- ment. The gold standard was fractional flow reserve measured by adenosine fractional flow reserve. Then cFFR and adenosine fractional flow reserve were compared between the groups, and the diagnostic values of both contrasts were calculated. Finally, the cut-point for diagnos- ing adenosine fractional flow reserve ≤ 0.8 was calculated for cFFR in both groups.
RESULTS


In this study, 46 patients were studied (24 patients received Ultravist and 22 patients received Visipaque). There was no significant difference between the groups in adenosine frac- tional flow reserve. Also, the mean cFFR was not different from the mean adenosine fractional flow reserve in both groups. There was a strong correlation between cFFR and adenosine frac- tional flow reserve for each of the contrasts (r = 0.937 for Ultravist and r = 0.927 for Visipaque). Both contrasts had high specificity to diagnose fractional flow reserve ≤ 0.8 (specificity = 1), and the sensitivities of cFFR for Ultravist and Visipaque were 83.3% and 94.7%. The cut-point to predict adenosine fractional flow reserve ≤ 0.80 was 0.845 for Ultravist and 0.835 for Visipaque.
CONCLUSIONS


Both iso-osmolar or low osmolar contrast media have an acceptable diagnostic accuracy in measuring cFFR.",2022,"The cut-point to predict adenosine fractional flow reserve ≤ 0.80 was 0.845 for Ultravist and 0.835 for Visipaque.
","['46 patients were studied (24 patients received Ultravist and 22 patients received', 'candidates for coronary angiography with intermediate cor- onary lesion']","['Low and Iso-osmolar Contrast Media', 'iso-osmolar contrast media (Visipaque) or a low osmolar contrast media (Ultravist) for fractional flow reserve measure- ment', 'Visipaque']","['cFFR and adenosine fractional flow reserve', 'Diagnostic Performance of Contrast Fractional Flow Reserve Measurement', 'cFFR and adenosine frac- tional flow reserve', 'mean adenosine fractional flow reserve', 'sensitivities of cFFR for Ultravist and Visipaque', 'adenosine fractional flow reserve', 'fractional flow reserve measured by adenosine fractional flow reserve', 'adenosine frac- tional flow reserve', 'mean cFFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0728741', 'cui_str': 'Ultravist'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0439351', 'cui_str': 'osmol/L'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0084844', 'cui_str': 'trestolone'}, {'cui': 'C0377786', 'cui_str': 'Visipaque'}]","[{'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0728741', 'cui_str': 'Ultravist'}, {'cui': 'C0377786', 'cui_str': 'Visipaque'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",46.0,0.0241542,"The cut-point to predict adenosine fractional flow reserve ≤ 0.80 was 0.845 for Ultravist and 0.835 for Visipaque.
","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rahmani', 'Affiliation': 'Department of Cardiology, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ramezani', 'Affiliation': 'Department of Cardiology, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Shafiee', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir,['10.5543/tkda.2022.21273']
1645,35657320,Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer.,"BACKGROUND


The role of adjuvant chemotherapy in stage II colon cancer continues to be debated. The presence of circulating tumor DNA (ctDNA) after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low risk of recurrence. The benefit of adjuvant chemotherapy for ctDNA-positive patients is not well understood.
METHODS


We conducted a trial to assess whether a ctDNA-guided approach could reduce the use of adjuvant chemotherapy without compromising recurrence risk. Patients with stage II colon cancer were randomly assigned in a 2:1 ratio to have treatment decisions guided by either ctDNA results or standard clinicopathological features. For ctDNA-guided management, a ctDNA-positive result at 4 or 7 weeks after surgery prompted oxaliplatin-based or fluoropyrimidine chemotherapy. Patients who were ctDNA-negative were not treated. The primary efficacy end point was recurrence-free survival at 2 years. A key secondary end point was adjuvant chemotherapy use.
RESULTS


Of the 455 patients who underwent randomization, 302 were assigned to ctDNA-guided management and 153 to standard management. The median follow-up was 37 months. A lower percentage of patients in the ctDNA-guided group than in the standard-management group received adjuvant chemotherapy (15% vs. 28%; relative risk, 1.82; 95% confidence interval [CI], 1.25 to 2.65). In the evaluation of 2-year recurrence-free survival, ctDNA-guided management was noninferior to standard management (93.5% and 92.4%, respectively; absolute difference, 1.1 percentage points; 95% CI, -4.1 to 6.2 [noninferiority margin, -8.5 percentage points]). Three-year recurrence-free survival was 86.4% among ctDNA-positive patients who received adjuvant chemotherapy and 92.5% among ctDNA-negative patients who did not.
CONCLUSIONS


A ctDNA-guided approach to the treatment of stage II colon cancer reduced adjuvant chemotherapy use without compromising recurrence-free survival. (Supported by the Australian National Health and Medical Research Council and others; DYNAMIC Australian New Zealand Clinical Trials Registry number, ACTRN12615000381583.).",2022,"Three-year recurrence-free survival was 86.4% among ctDNA-positive patients who received adjuvant chemotherapy and 92.5% among ctDNA-negative patients who did not.
","['Stage II Colon Cancer', 'stage II colon cancer', '455 patients who underwent randomization', 'Patients with stage II colon cancer']","['oxaliplatin-based or fluoropyrimidine chemotherapy', 'adjuvant chemotherapy', 'ctDNA-guided approach']","['recurrence-free survival', '2-year recurrence-free survival, ctDNA-guided management']","[{'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",455.0,0.273693,"Three-year recurrence-free survival was 86.4% among ctDNA-positive patients who received adjuvant chemotherapy and 92.5% among ctDNA-negative patients who did not.
","[{'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Tie', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Cohen', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Lahouel', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Serigne N', 'Initials': 'SN', 'LastName': 'Lo', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Yuxuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Kosmider', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wong', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burge', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lynam', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Nott', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Day', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hayes', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Sue-Anne', 'Initials': 'SA', 'LastName': 'McLachlan', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Ptak', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Silliman', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dobbyn', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Popoli', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Hruban', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Lennon', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Papadopoulos', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Kinzler', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Vogelstein', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Tomasetti', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': ""From the Division of Personalised Oncology, Walter and Eliza Hall Institute of Medical Research (J.T., R.W., M.L., B.L., P.G.), the Department of Medical Oncology, Peter MacCallum Cancer Centre (J.T., B.L.), the Department of Medical Oncology, Western Health (J.T., S.K., M.L., P.G.), the Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne (J.T., P.G.), the Department of Medical Oncology, Eastern Health (R.W., M.L.), the Eastern Health Clinical School, Faculty of Medicine, Nursing, and Health Sciences, Monash University (R.W., M.L.), the Department of Medical Oncology, Cabrini Health (J.S.), the Department of Medical Oncology, Monash Health (M.H.), the Department of Medical Oncology, St. Vincent's Hospital (S.-A.M.), and the Department of Medical Oncology, Northern Health (B.L.), Melbourne, VIC, the Research and Biostatistics Group, Melanoma Institute Australia, and the Faculty of Medicine and Health, University of Sydney, Sydney (S.N.L.), the Department of Medical Oncology, Bendigo Health, Bendigo, VIC (S.H.), the Department of Medical Oncology, Fiona Stanley Hospital, and Edith Cowan University, Perth, WA (A.K.), the Department of Medical Oncology, Royal Brisbane and Women's Hospital, and the University of Queensland, Brisbane, QLD (M.B.), Newcastle Private Hospital (J.L.), and the Department of Medical Oncology, Calvary Mater Newcastle Hospital (F.D.), Newcastle, NSW, the Department of Medical Oncology, Royal Hobart Hospital, Hobart, TAS (L.N.), and South West Healthcare, Warrnambool, VIC (T.H.) - all in Australia; the Ludwig Center for Cancer Genetics and Therapeutics (J.D.C., Y.W., J.P., N.S., L.D., M.P., N.P., K.W.K., B.V.), the Division of Biostatistics and Bioinformatics (K.L., C.T.), Department of Oncology, Sidney Kimmel Comprehensive Cancer Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), the Sol Goldman Pancreatic Cancer Research Center (J.D.C., Y.W., J.P., N.S., L.D., M.P., R.H., A.M.L., N.P., K.W.K., B.V.), and the Departments of Pathology (R.H.) and Medicine (A.M.L.), Johns Hopkins University School of Medicine, the Howard Hughes Medical Institute (J.P., N.S., B.V.), the Department of Biomedical Engineering, Johns Hopkins University (J.D.C.), and the Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health (C.T.) - all in Baltimore; and the Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (S.N.L.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2200075']
1646,35688920,An alternative method for personalized tourniquet pressure in total knee arthroplasty: a prospective randomized and controlled study.,"Tourniquet use always carries potential risks, which can range from mild transient functional impairments of thigh pain, skin blisters to severe permanent dysfunction of limb paralysis, nerve injuries or compartment syndrome. The ideal method for minimizing intraoperative tourniquet pressure (TP) for reducing postoperative complications remains controversial. In this prospective, randomized and controlled study, we reinvestigated an estimation formula for TP based on thigh circumferences and systolic blood pressure (SBP) with two traditional methods for TP determination in total knee arthroplasty (TKA): SBP plus 100 mmHg and a fixed value of 300 mmHg. TP values and postoperative thigh pain scores were compared among three groups. The intraoperative TP value of the formula-calculated group was lower than that of the traditional groups (14.7 mmHg, P = 0.3475 and 94.7 mmHg, P < 0.0001, respectively), while no differences of hemostatic effect at the surgical fields and wound complications were detected among groups. The thigh pain scores at the tourniquet site decreased gradually over time and the estimation group had the lowest scores at each timepoint after surgery. Estimation method for TP was easy and rapid, without relying on specific equipment. It could provide a practical low TP and comparable hemostatic effect in TKA using an inflating tourniquet.",2022,The thigh pain scores at the tourniquet site decreased gradually over time and the estimation group had the lowest scores at each timepoint after surgery.,"['total knee arthroplasty', 'total knee arthroplasty (TKA): SBP plus 100\xa0mmHg and a fixed value of 300\xa0mmHg']",['intraoperative tourniquet pressure (TP'],"['thigh circumferences and systolic blood pressure (SBP', 'hemostatic effect at the surgical fields and wound complications', 'thigh pain scores', 'TP values and postoperative thigh pain scores', 'intraoperative TP value']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0241374', 'cui_str': 'Thigh pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",,0.0244207,The thigh pain scores at the tourniquet site decreased gradually over time and the estimation group had the lowest scores at each timepoint after surgery.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Changzheng Hospital, Naval Medical University, 415#, Fengyang Road, Huangpu District, Shanghai, 200003, China.'}, {'ForeName': 'QiWei', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Changzheng Hospital, Naval Medical University, 415#, Fengyang Road, Huangpu District, Shanghai, 200003, China.'}, {'ForeName': 'HaoBo', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Changzheng Hospital, Naval Medical University, 415#, Fengyang Road, Huangpu District, Shanghai, 200003, China.'}, {'ForeName': 'YaGuang', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Changzheng Hospital, Naval Medical University, 415#, Fengyang Road, Huangpu District, Shanghai, 200003, China.'}, {'ForeName': 'JianHua', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': ""Department of Orthopaedic Surgery, Nantong Hospital Affiliated to Shanghai University (Nantong Sixth People's Hospital), 500#, Yonghe Road, Chongchuan District, Nantong, Jiangsu Province, 226011, China. jsntdeng@sina.com.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Changzheng Hospital, Naval Medical University, 415#, Fengyang Road, Huangpu District, Shanghai, 200003, China. lother@163.com.'}, {'ForeName': 'QiRong', 'Initials': 'Q', 'LastName': 'Qian', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Changzheng Hospital, Naval Medical University, 415#, Fengyang Road, Huangpu District, Shanghai, 200003, China. qianqr@163.com.'}]",Scientific reports,['10.1038/s41598-022-13672-6']
1647,35689370,Efficacy of Focused Extracorporeal Shock Wave Therapy in Chronic Low Back Pain: A Prospective Randomized 3-Month Follow-Up Study.,"BACKGROUND Extracorporeal shock wave therapy (ESWT) is a modern physiotherapeutic method that is useful for treating musculoskeletal conditions. There are still limited data from well-designed studies evaluating the clinical efficiency of ESWT in low back pain (LBP). Therefore, this study aimed to assess the effectiveness of the focused ESWT (fESWT) in reducing pain and improving the functional status of patients with chronic LBP. MATERIAL AND METHODS The study involved 40 patients with L5-S1 discopathy with chronic LBP pain who were randomized into 2 groups: group A (n=20, mean age of 42.3±13.1 years) and group B (n=20, mean age of 45.4±14 years). Group A was an experimental group treated with an fESWT at the lumbar and sacral spine (0.15 mJ/mm², 1000 pulses, 4 Hz). Group B was a control group, treated with a sham fESWT. The treatment protocol in both groups included identical stabilization training (45 minutes, once a day, 5 days a week). Study outcomes included subjective pain with a visual analog scale (VAS) and Laitinen Pain Scale (LPS), and functional status using the Oswestry Disability Index (ODI). Measurements were made before and after treatments, as well as follow-up observations at 1 and 3 months following ESWT. The study was prospectively registered at the ISRCTN registry platform (no. ISRCTN13785224). RESULTS There was a significant analgesic effect (VAS and LPS) in both groups; however, it was significantly greater in the experimental group compared to the sham group (P<0.05). A more significant decrease in the perceived pain (VAS and LPS) was observed immediately after the active fESWT therapy. In follow-up observations (after 1 and 3 months), there were no significant between-group differences (P>0.05). Also, there was a significant effect in terms of functional state (ODI) for both groups (P<0.05); however, between-group comparisons revealed no statistically significant differences (P>0.05). CONCLUSIONS Focused ESWT with an exercise program can be effective in patients with chronic LBP. ESWT allows reducing pain, although it does not seem to significantly improve a patient's functional state.",2022,"There was a significant analgesic effect (VAS and LPS) in both groups; however, it was significantly greater in the experimental group compared to the sham group (P<0.05).","['40 patients with L5-S1 discopathy with chronic LBP pain who were randomized into 2 groups: group A (n=20, mean age of 42.3±13.1 years) and group B (n=20, mean age of 45.4±14 years', 'Chronic Low Back Pain', 'patients with chronic LBP']","['Extracorporeal shock wave therapy (ESWT', 'ESWT with an exercise program', 'ESWT', 'identical stabilization training', 'fESWT at the lumbar and sacral spine', 'ESWT (fESWT', 'Extracorporeal Shock Wave Therapy']","['analgesic effect (VAS and LPS', 'pain', 'subjective pain with a visual analog scale (VAS) and Laitinen Pain Scale (LPS), and functional status using the Oswestry Disability Index (ODI', 'perceived pain (VAS and LPS', 'functional state (ODI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2747858', 'cui_str': 'Discopathy'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1301808', 'cui_str': 'State'}]",40.0,0.0153272,"There was a significant analgesic effect (VAS and LPS) in both groups; however, it was significantly greater in the experimental group compared to the sham group (P<0.05).","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Rajfur', 'Affiliation': 'Institute of Health Sciences, University of Opole, Opole, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Rajfur', 'Affiliation': 'Institute of Health Sciences, University of Opole, Opole, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Matusz', 'Affiliation': 'Institute of Health Sciences, University of Opole, Opole, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Walewicz', 'Affiliation': 'Institute of Health Sciences, University of Opole, Opole, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dymarek', 'Affiliation': 'Department of Physiotherapy, Institute of Health Sciences, Wrocław Medical University, Wrocław, Poland.'}, {'ForeName': 'Kuba', 'Initials': 'K', 'LastName': 'Ptaszkowski', 'Affiliation': 'Department of Physiotherapy, Wrocław Medical University, Wrocław, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Taradaj', 'Affiliation': 'Institute of Physiotherapy and Health Sciences, Academy of Physical Education, Katowice, Poland.'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.936614']
1648,35689278,Clinical evaluation of usefulness and effectiveness of sitting type continuous passive motion machines in patients with total knee arthroplasty: a study protocol for a single-blinded randomized controlled trial.,"BACKGROUND


Total knee arthroplasty (TKA) is an important management strategy for patients with knee osteoarthritis (OA) refractory to conservative management. Postoperative range of motion (ROM) exercise is important to recover patients' activities of daily living. Continuous passive motion (CPM) is a machine that provides passive ROM exercises of the knee joint in a pre-defined arc of motion. The short- and long-term effects of CPM exercise are controversial. We hypothesized that the inconsistent results of the CPM exercise are due to poor fitting of CPM machines and measurement errors. This study aims to present a protocol for investigating a new type of CPM machine that could be applied in a sitting position in comparison with the conventional type of CPM machine for patients with unilateral TKAs.
METHODS


This study presents the protocol of a prospective, multicenter, single-blinded, three-armed randomized controlled trial (RCT). One hundred and twenty-six patients receiving unilateral TKAs will be recruited at the physical medicine and rehabilitation clinics of two urban tertiary medical hospitals. The patients were randomly divided into three groups with a 1:1:1 allocation. The intervention group will receive two weeks of post-operative rehabilitation using a new type of CPM machine. The control group will receive 2 weeks of post-operative rehabilitation using conventional CPM machines. The third group will receive post-operative rehabilitation with both types of CPM machines. The primary outcome will be the change in the passive ROM of the affected knee joint from baseline to 2 weeks after baseline assessment. The secondary outcomes will be pain and functional measurements, and will include patient-reported outcomes and performance tests surveyed at multiple time points up to 3 months after TKA.
DISCUSSION


This is the first RCT to investigate the effect of a new type of CPM machine. The results of this RCT will determine whether the position of the patients during CPM exercise is important in post-operative rehabilitation protocols after TKAs and will provide evidence for the development of proper rehabilitation guidelines after TKAs.
TRIAL REGISTRATION


Clinical Research Information Service of Republic of Korea, KCT0005520, Registered on 21 October 2020, https://cris.nih.go.kr/cris/search/detailSearch.do/21750.",2022,The primary outcome will be the change in the passive ROM of the affected knee joint from baseline to 2 weeks after baseline assessment.,"['patients with total knee arthroplasty', 'patients with knee osteoarthritis (OA) refractory to conservative management', 'One hundred and twenty-six patients receiving unilateral TKAs will be recruited at the physical medicine and rehabilitation clinics of two urban tertiary medical hospitals', 'patients with unilateral TKAs']","['CPM exercise', 'Postoperative range of motion (ROM) exercise', 'Continuous passive motion (CPM', 'post-operative rehabilitation using a new type of CPM machine', 'conventional CPM machines', 'sitting type continuous passive motion machines', 'Total knee arthroplasty (TKA', 'CPM machine']","['passive ROM of the affected knee joint', 'pain and functional measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.109909,The primary outcome will be the change in the passive ROM of the affected knee joint from baseline to 2 weeks after baseline assessment.,"[{'ForeName': 'Byung Chan', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University College of Medicine, 266 Munhwa-ro, Jung-gu, Daejeon, 35015, Korea.'}, {'ForeName': 'Chang Won', 'Initials': 'CW', 'LastName': 'Moon', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University College of Medicine, 266 Munhwa-ro, Jung-gu, Daejeon, 35015, Korea.'}, {'ForeName': 'Woo Sung', 'Initials': 'WS', 'LastName': 'Choi', 'Affiliation': 'Department of Biomedical Institute, Chungnam National University, Daejeon, Korea.'}, {'ForeName': 'Young Mo', 'Initials': 'YM', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Yong Bum', 'Initials': 'YB', 'LastName': 'Joo', 'Affiliation': 'Department of Orthopedic Surgery, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Da Gyo', 'Initials': 'DG', 'LastName': 'Lee', 'Affiliation': 'Catholic University of Korea Industry Academic Cooperation Foundation. The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Sook Joung', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': ""Department of Rehabilitation Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Eun Seok', 'Initials': 'ES', 'LastName': 'Choi', 'Affiliation': ""Department of Rehabilitation Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Jong Hun', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': ""Department of Orthopedic Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Dong Whan', 'Initials': 'DW', 'LastName': 'Suh', 'Affiliation': ""Department of Orthopedic Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Kang Hee', 'Initials': 'KH', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University College of Medicine, 266 Munhwa-ro, Jung-gu, Daejeon, 35015, Korea. khcho@cnu.ac.kr.'}]",BMC musculoskeletal disorders,['10.1186/s12891-022-05507-2']
1649,35689274,"The effect of a probiotic on gastrointestinal symptoms due to menstruation in healthy adult women on oral contraceptives: randomized, double-blind, placebo-controlled trial protocol.","INTRODUCTION


For many women, uncomfortable and stressful symptoms accompany the menstrual cycle each month, sometimes in a debilitating manner. Previous studies have reported that gastrointestinal symptoms in healthy women significantly differ by the day of the menstrual cycle, but few studies have assessed interventions intended to minimize these symptoms. Probiotics supplements have been shown to attenuate gastrointestinal symptom severity as well as self-reported feelings of stress in various populations. This study evaluates the effect of a probiotic on abdominal pain and gastrointestinal symptoms in healthy women who take an oral contraceptive, have regular menses, and typically experience these symptoms during menstruation with the primary aim being change in abdominal pain intensity related to the menstrual cycle with probiotic versus placebo supplementation.
METHODS AND ANALYSIS


In this randomized, double-blind, placebo-controlled parallel study, participants will receive either a probiotic or placebo supplement. Participants will begin answering questionnaires approximately 7 days before the start of menstruation (i.e., active bleeding), and 3 days later, they will begin consuming the study supplement for 8 weeks. The questionnaires administered will collect data about abdominal pain severity (primary outcome) and duration related to the menstrual cycle, digestive health, dietary intake, stress, and digestion-associated quality-of-life. A subgroup of women will provide weekly vaginal swabs and stool samples to examine the effect of the probiotic supplement on microbiota composition and diversity for exploratory purposes. Two-sided tests using a linear model and a type I error rate of α = 0.05 will be employed to test all hypotheses. Continuous variables will be presented as means with standard errors and categorical variables, as counts or proportions.
ETHICS AND DISSEMINATION


This study was reviewed and approved by the University of Florida Institutional Review Board 01. Written informed consent will be obtained from all participants prior to any study activities. Study findings will be disseminated at scientific conferences and publication in the trial registry or in a peer-reviewed journal. Any protocol amendments will be reported in the final manuscript of this study.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04457401 . Registered prospectively on 07 July 2020. The trial was completed in December of 2021.
PROTOCOL VERSION


V4.0 (11-04-2020) TRIAL STATUS: Currently recruiting. Recruitment began in November 2020 and extend until December 2021.",2022,Probiotics supplements have been shown to attenuate gastrointestinal symptom severity as well as self-reported feelings of stress in various populations.,"['V4.0', 'healthy women who take an oral contraceptive, have regular menses', 'healthy adult women on oral contraceptives', 'healthy women', 'Registered prospectively on 07 July 2020']","['placebo supplementation', 'probiotic', 'probiotic supplement', 'probiotic or placebo supplement', 'Probiotics supplements', 'placebo']","['gastrointestinal symptoms', 'abdominal pain severity (primary outcome) and duration related to the menstrual cycle, digestive health, dietary intake, stress, and digestion-associated quality-of-life', 'abdominal pain and gastrointestinal symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.533465,Probiotics supplements have been shown to attenuate gastrointestinal symptom severity as well as self-reported feelings of stress in various populations.,"[{'ForeName': 'Taylor C', 'Initials': 'TC', 'LastName': 'Judkins', 'Affiliation': 'Food Science and Human Nutrition Department, University of Florida, 572 Newell Dr, Gainesville, FL, 32611, USA. tmcombs@ufl.edu.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Oula', 'Affiliation': 'Lallemand Health Solutions, 6100 Royalmount avenue, Montreal, QC, H4P 2R2, Canada.'}, {'ForeName': 'Shireen Madani', 'Initials': 'SM', 'LastName': 'Sims', 'Affiliation': 'Univeristy of Florida College of Medicine, PO Box 100294, Gainesville, FL, 32610, USA.'}, {'ForeName': 'Bobbi', 'Initials': 'B', 'LastName': 'Langkamp-Henken', 'Affiliation': 'Food Science and Human Nutrition Department, University of Florida, 572 Newell Dr, Gainesville, FL, 32611, USA.'}]",Trials,['10.1186/s13063-022-06410-w']
1650,35689272,Rifapentine and isoniazid for prevention of tuberculosis in people with diabetes (PROTID): protocol for a randomised controlled trial.,"BACKGROUND


Diabetes mellitus (DM) increases the risk of tuberculosis (TB) and will hamper global TB control due to the dramatic rise in type 2 DM in TB-endemic settings. In this trial, we will examine the efficacy and safety of TB preventive therapy against the development of TB disease in people with DM who have latent TB infection (LTBI), with a 12-week course of rifapentine and isoniazid (3HP).
METHODS


The 'Prevention of tuberculosis in diabetes mellitus' (PROTID) consortium will randomise 3000 HIV-negative eligible adults with DM and LTBI, as evidenced by a positive tuberculin skin test or interferon gamma release assay, to 12 weeks of 3HP or placebo. Participants will be recruited through screening adult patients attending DM clinics at referral hospitals in Tanzania and Uganda. Patients with previous TB disease or treatment with a rifamycin medication or isoniazid (INH) in the previous 2 years will be excluded. The primary outcome is the occurrence of definite or probable TB disease; secondary outcome measures include adverse events, all-cause mortality and treatment completion. The primary efficacy analysis will be intention-to-treat; per-protocol analyses will also be carried out. We will estimate the ratio of TB incidence rates in intervention and control groups, adjusting for the study site using Poisson regression. Results will be reported as efficacy estimates (1-rate ratio). Cumulative incidence rates allowing for death as a competing risk will also be reported. Approximately 1000 LTBI-negative, HIV-negative participants will be enrolled consecutively into a parallel cohort study to compare the incidence of TB in people with DM who are LTBI negative vs positive. A number of sub-studies will be conducted among others to examine the prevalence of LTBI and active TB, estimate the population impact and cost-effectiveness of LTBI treatment in people living with DM in these African countries and address gaps in the prevention and therapeutic management of combined TB-DM.
DISCUSSION


PROTID is anticipated to generate key evidence to guide decisions over the use of TB preventive treatment among people with DM as an important target group for better global TB control.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04600167 . Registered on 23 October 2020.",2022,"PROTID is anticipated to generate key evidence to guide decisions over the use of TB preventive treatment among people with DM as an important target group for better global TB control.
","['people with DM who have latent TB infection (LTBI', 'Participants will be recruited through screening adult patients attending DM clinics at referral hospitals in Tanzania and Uganda', 'people with diabetes (PROTID', 'Patients with previous TB disease or treatment with a', 'Approximately 1000 LTBI-negative, HIV-negative participants', 'people with DM who are LTBI negative vs positive', ""The 'Prevention of tuberculosis in diabetes mellitus' (PROTID) consortium will randomise 3000 HIV-negative eligible adults with DM and LTBI, as evidenced by a positive tuberculin skin test or interferon gamma release assay, to 12\u2009weeks of""]","['3HP or placebo', 'TB preventive therapy', 'rifamycin medication or isoniazid (INH', 'Rifapentine and isoniazid', 'rifapentine and isoniazid (3HP']","['adverse events, all-cause mortality and treatment completion', 'ratio of TB incidence rates', 'occurrence of definite or probable TB disease']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0032739', 'cui_str': 'Mantoux: positive'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0740413', 'cui_str': 'Tuberculosis prophylaxis'}, {'cui': 'C0035609', 'cui_str': 'Rifamycins'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",3000.0,0.507306,"PROTID is anticipated to generate key evidence to guide decisions over the use of TB preventive treatment among people with DM as an important target group for better global TB control.
","[{'ForeName': 'Nyanda Elias', 'Initials': 'NE', 'LastName': 'Ntinginya', 'Affiliation': 'National Institute for Medical Research (NIMR), Mbeya Medical Research Centre, Mbeya, Tanzania. nelias@nimr-mmrc.org.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Te Brake', 'Affiliation': 'Departmentt of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), Nijmegen, The Netherlands.'}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Sabi', 'Affiliation': 'National Institute for Medical Research (NIMR), Mbeya Medical Research Centre, Mbeya, Tanzania.'}, {'ForeName': 'Nyasatu', 'Initials': 'N', 'LastName': 'Chamba', 'Affiliation': 'The Good Samaritan Foundation (Kilimanjaro Christian Medical Centre GSF KCMC), Moshi, Tanzania.'}, {'ForeName': 'Kajiru', 'Initials': 'K', 'LastName': 'Kilonzo', 'Affiliation': 'The Good Samaritan Foundation (Kilimanjaro Christian Medical Centre GSF KCMC), Moshi, Tanzania.'}, {'ForeName': 'Sweetness', 'Initials': 'S', 'LastName': 'Laizer', 'Affiliation': 'The Good Samaritan Foundation (Kilimanjaro Christian Medical Centre GSF KCMC), Moshi, Tanzania.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Andia-Biraro', 'Affiliation': 'Department of Internal Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Davis', 'Initials': 'D', 'LastName': 'Kibirige', 'Affiliation': 'Uganda Martyrs Hospital Lubaga, Kampala, Uganda.'}, {'ForeName': 'Andrew Peter', 'Initials': 'AP', 'LastName': 'Kyazze', 'Affiliation': 'Department of Internal Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ninsiima', 'Affiliation': 'Department of Internal Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Critchley', 'Affiliation': ""St George's University of London, London, UK.""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Romeo', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'van de Maat', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Willyhelmina', 'Initials': 'W', 'LastName': 'Olomi', 'Affiliation': 'National Institute for Medical Research (NIMR), Mbeya Medical Research Centre, Mbeya, Tanzania.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Mrema', 'Affiliation': 'National Institute for Medical Research (NIMR), Mbeya Medical Research Centre, Mbeya, Tanzania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Magombola', 'Affiliation': 'National Institute for Medical Research (NIMR), Mbeya Medical Research Centre, Mbeya, Tanzania.'}, {'ForeName': 'Issakwisa Habakkuk', 'Initials': 'IH', 'LastName': 'Mwayula', 'Affiliation': 'Mbeya Zonal Referral Hospital (MZRH), Mbeya, Tanzania.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Sharples', 'Affiliation': 'Otago Global Health Institute, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Hill', 'Affiliation': 'Otago Global Health Institute, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-022-06296-8']
1651,35689257,"Effect of time restricted feeding on anthropometric measures, eating behavior, stress, and brain-derived neurotrophic factor (BDNF) and lipopolysaccharide-binding protein (LBP) levels in women with overweight/obesity and food addiction: a study protocol for a randomized clinical trial.","BACKGROUND


Food addiction is one of the behavioral factors that play an important role in the pathogenesis of obesity. Much evidence is available suggesting intestinal microbiomes can play a role in eating behavior, body composition, and BDNF levels, and they can be modified by time-restricted feeding (TRF). So, this study will aim to evaluate the effect of TRF on anthropometric measures, eating behavior, stress, and serum BDNF and LBP levels in women with overweight/obesity and food addiction.
METHODS


We will carry out a randomized clinical trial for 8 weeks to evaluate the effect of a TRF on anthropometric measures, eating behavior, stress level, serum BDNF and LBP levels in women with overweight/obesity and food addiction.
DISCUSSION


Given the effect of BDNF on regulating eating behavior and body weight and the effect of dietary restrictions on BDNF and the gut microbiome, the TRF diet could possibly be a new way to successfully manage weight through modifying BDNF in people with eating disorders, including food addiction.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials IRCT20131228015968N7 . Registered on 25 October 2020.",2022,"Given the effect of BDNF on regulating eating behavior and body weight and the effect of dietary restrictions on BDNF and the gut microbiome, the TRF diet could possibly be a new way to successfully manage weight through modifying BDNF in people with eating disorders, including food addiction.
","['people with eating disorders', 'women with overweight/obesity and food addiction']","['TRF', 'BDNF']","['eating behavior and body weight', 'anthropometric measures, eating behavior, stress level, serum BDNF and LBP levels', 'anthropometric measures, eating behavior, stress, and serum BDNF and LBP levels', 'anthropometric measures, eating behavior, stress, and brain-derived neurotrophic factor (BDNF) and lipopolysaccharide-binding protein (LBP) levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]","[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}]",,0.0578369,"Given the effect of BDNF on regulating eating behavior and body weight and the effect of dietary restrictions on BDNF and the gut microbiome, the TRF diet could possibly be a new way to successfully manage weight through modifying BDNF in people with eating disorders, including food addiction.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Irani', 'Affiliation': 'Department of Nutrition, Faculty of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Banafsheh', 'Initials': 'B', 'LastName': 'Khodami', 'Affiliation': 'Department of Nutrition, Faculty of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atoosa', 'Initials': 'A', 'LastName': 'Saidpour', 'Affiliation': 'Department of Nutrition, Faculty of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. atoosa.saidpour@gmail.com.'}]",Trials,['10.1186/s13063-022-06439-x']
1652,35689904,Investigation of the effect of delayed auditory feedback and transcranial direct current stimulation (DAF-tDCS) treatment for the enhancement of speech fluency in adults who stutter: A randomized controlled trial.,"BACKGROUND


Stuttering is a disorder that begins in childhood and can persist into adulthood. In the present study, it was hypothesized that the combined intervention of transcranial direct current stimulation (tDCS) and Delayed Auditory Feedback (DAF) would cause greater improvement in speech fluency in comparison to the intervention with DAF alone.
METHODS


A randomized, double-blind, sham-controlled clinical trial was conducted to investigate the effects of the combined intervention. Fifty adults with moderate to severe stuttering (25 females, 25 males, Mean age=26.92, SD=6.23) were randomly allocated to the anodal or sham tDCS group. In the anodal tDCS group, participants received DAF combined with anodal tDCS (1 mA), while the sham tDCS group was exposed to sham tDCS simultaneously with DAF. In this study, a 60-ms delay was used for DAF intervention, and tDCS was applied over the left superior temporal gyrus. Each individual participated in six 20-minute intervention sessions (held on six consecutive days). Speech fluency was assessed before and after the intervention.
RESULTS


In the anodal tDCS group, the scores of the Stuttering Severity Instrument, Overall Assessment of the Speaker's Experience of Stuttering questionnaire, and the percentage of stuttered syllable reduced significantly (from average baseline rates of 8.45%, across three tasks, to 5.36% at the follow-up assessment) after the intervention.
CONCLUSION


The results of this study suggest that delivery of anodal tDCS when combined with DAF may enhance stuttering reduction effects for six weeks following the intervention.",2022,"In the anodal tDCS group, the scores of the Stuttering Severity Instrument, Overall Assessment of the Speaker's Experience of Stuttering questionnaire, and the percentage of stuttered syllable reduced significantly (from average baseline rates of 8.45%, across three tasks, to 5.36% at the follow-up assessment) after the intervention.
","['Fifty adults with moderate to severe stuttering (25 females, 25 males, Mean age=26.92, SD=6.23', 'adults who stutter']","['anodal or sham tDCS', 'transcranial direct current stimulation (tDCS) and Delayed Auditory Feedback (DAF', 'delayed auditory feedback and transcranial direct current stimulation (DAF-tDCS', 'anodal tDCS', 'DAF combined with anodal tDCS (1\xa0mA), while the sham tDCS group was exposed to sham tDCS simultaneously with DAF', 'DAF']","['Speech fluency', 'speech fluency', 'percentage of stuttered syllable', ""scores of the Stuttering Severity Instrument, Overall Assessment of the Speaker's Experience of Stuttering questionnaire""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0233714', 'cui_str': 'Fluency of speech'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",50.0,0.144648,"In the anodal tDCS group, the scores of the Stuttering Severity Instrument, Overall Assessment of the Speaker's Experience of Stuttering questionnaire, and the percentage of stuttered syllable reduced significantly (from average baseline rates of 8.45%, across three tasks, to 5.36% at the follow-up assessment) after the intervention.
","[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Moein', 'Affiliation': 'Department of Speech-Language Pathology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Madadkaran St., Shahnazari Ave., Mirdamad Blvd., Madar Sq., Tehran, Iran. Electronic address: moin.narges@gmail.com.'}, {'ForeName': 'Reyhane', 'Initials': 'R', 'LastName': 'Mohamadi', 'Affiliation': 'Department of Speech-Language Pathology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Rehabilitationresearch Center, Iran University of Medical Sciences, Madadkaran St., Shahnazari Ave., Mirdamad Blvd., Madar Sq., Tehran, Iran. Electronic address: mohamadi.r@iums.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rostami', 'Affiliation': 'Faculty of Psychology and Education, University of Tehran, Dr. Kardan St., Jalal-Al-e-Ahmed Ave., Chamran Hwy., Tehran, Iran. Electronic address: rrostami@ut.ac.ir.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nitsche', 'Affiliation': 'Department of psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Ardeystrasse 67, Dortmund, Germany. Electronic address: nitsche@ifado.de.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, University of Toronto, Russell St., Toronto, Ontario, Canada. Electronic address: Reza.Zomorrodi@camh.ca.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ostadi', 'Affiliation': 'University of Waterloo, Waterloo, Ontario, Canada. Electronic address: Amir.ostadi@gmail.com.'}]",Journal of fluency disorders,['10.1016/j.jfludis.2022.105907']
1653,35690181,"A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-caffeine in healthy subjects.","The deuterium kinetic isotope effect has been used to affect the cytochrome P450 metabolism of the deuterated versions of substances. This study compares the pharmacokinetics of caffeine, a Generally Recognized As Safe food and beverage ingredient, versus d9-caffeine, a potential caffeine alternative, and their respective metabolites at two dose levels in 20 healthy adults. A single dose of 50 mg or 250 mg of caffeine, or a molar-equivalent dose of d9-caffeine, were orally administered in solution with blood samples collected for up to 48 h post-dose. Plasma concentrations of parent and metabolites were analyzed using validated LC-MS/MS methods. Both d9-caffeine and caffeine were rapidly absorbed; however, d9-caffeine exhibited a higher (ca. 29%-43%) C max  and 4-5-fold higher AUC last  than caffeine, and lower C max , lower AUC last , and a 5-10-fold reduction in the relative exposure to the active metabolites of caffeine. Results were consistent in normal and rapid metabolizers, and both substances were well tolerated.",2022,"C max  and 4-5-fold higher AUC last  than caffeine, and lower C max , lower AUC last , and a 5-10-fold reduction in the relative exposure to the active metabolites of caffeine.","['20 healthy adults', 'healthy subjects']","['d9-caffeine and caffeine', 'caffeine versus d9-Caffeine', 'caffeine', '50\u202fmg or 250\u202fmg of caffeine, or a molar-equivalent dose of d9-caffeine']","['Plasma concentrations of parent and metabolites', 'tolerated']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",20.0,0.0728145,"C max  and 4-5-fold higher AUC last  than caffeine, and lower C max , lower AUC last , and a 5-10-fold reduction in the relative exposure to the active metabolites of caffeine.","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Sherman', 'Affiliation': 'Lennham Pharmaceuticals, Inc., Concord, MA, USA. Electronic address: marymsherman@verizon.net.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Tarantino', 'Affiliation': 'Lennham Pharmaceuticals, Inc., Concord, MA, USA.'}, {'ForeName': 'Dennis N', 'Initials': 'DN', 'LastName': 'Morrison', 'Affiliation': 'QPS LLC (Bio-Kinetic Clinical Applications, LLC), Springfield, MO, USA.'}, {'ForeName': 'Chun-Han', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'QPS, Taiwan.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Parente', 'Affiliation': 'Burdock Group Consulting, Orlando, FL, USA.'}, {'ForeName': 'Bradford C', 'Initials': 'BC', 'LastName': 'Sippy', 'Affiliation': 'Lennham Pharmaceuticals, Inc., Concord, MA, USA.'}]",Regulatory toxicology and pharmacology : RTP,['10.1016/j.yrtph.2022.105194']
1654,35690500,Phase 1/2 study of a novel 24-valent pneumococcal vaccine in healthy adults aged 18 to 64 years and in older adults aged 65 to 85 years.,"BACKGROUND


Pneumococcal diseases remain prevalent despite available polysaccharide and conjugate vaccines. This phase 1/2 study evaluated safety/tolerability and immunogenicity of a novel 24-valent pneumococcal vaccine (ASP3772) based on high-affinity complexing of proteins and polysaccharides.
METHODS


Pneumococcal vaccine-naïve adults aged 18-85 years were randomized to receive either ASP3772 or PCV13 (13-valent conjugate vaccine). Participants received a single intramuscular injection of ASP3772 (1-, 2-, or 5-µg dose per polysaccharide) or PCV13. A separate, nonrandomized group of PCV13-vaccinated participants (65-85 years) received PPSV23 (23-valent polysaccharide vaccine). Assessments were obtained through Day 7 for reactogenicity, through Day 30 for safety and tolerability, and through Month 6 for serious adverse events. Immunogenicity was measured at Day 30 using assays for functional opsonophagocytic activity (OPA) and pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G for each serotype.
RESULTS


In both age cohorts, the most frequently reported local reactions were self-limited tenderness and pain after ASP3772 at all dose levels or after PCV13, occurring within 2-3 days. Fatigue, headache, and myalgia were the most frequently reported systemic reactions following either vaccine. Robust OPA responses for all serotypes were observed across all ASP3772 dose groups in both age cohorts. Older adults (aged 65-85 years) who received ASP3772 had significantly higher immune responses to several PCV13 serotypes and all non-PCV13 serotypes than participants who received PCV13. OPA responses to the ASP3772 5-µg dose were significantly higher for several serotypes in naïve participants than in older adults with prior exposure to PCV13 who were administered PPSV23 in this study.
CONCLUSIONS


These results demonstrate that ASP3772 is well tolerated, highly immunogenic, and in adults may offer significantly broader protection than existing pneumococcal vaccines.
CLINICALTRIALS


gov: NCT03803202.",2022,Older adults (aged 65-85 years) who received ASP3772 had significantly higher immune responses to several PCV13 serotypes and all non-PCV13 serotypes than participants who received PCV13.,"['Pneumococcal vaccine-naïve adults aged 18-85\xa0years', 'healthy adults aged 18 to 64 years and in older adults aged 65 to 85 years', 'Older adults (aged 65-85\xa0years', 'participants (65-85\xa0years) received']","['PCV13', 'novel 24-valent pneumococcal vaccine', 'novel 24-valent pneumococcal vaccine (ASP3772', 'PPSV23', 'PCV13-vaccinated', 'ASP3772 or PCV13 (13-valent conjugate vaccine', 'ASP3772']","['Fatigue, headache, and myalgia', 'safety/tolerability and immunogenicity', 'OPA responses', 'safety and tolerability, and through Month 6 for serious adverse events', 'Robust OPA responses', 'Immunogenicity']","[{'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}, {'cui': 'C0947642', 'cui_str': 'Pneumovax 23'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.238061,Older adults (aged 65-85 years) who received ASP3772 had significantly higher immune responses to several PCV13 serotypes and all non-PCV13 serotypes than participants who received PCV13.,"[{'ForeName': 'Gurunadh R', 'Initials': 'GR', 'LastName': 'Chichili', 'Affiliation': 'Astellas Pharma, Inc., 1 Astellas Way, Northbrook, IL 60062, United States. Electronic address: gurunadh.chichili@astellas.com.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Smulders', 'Affiliation': 'Astellas Pharma, Inc., 1 Astellas Way, Northbrook, IL 60062, United States.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Santos', 'Affiliation': 'Astellas Pharma, Inc., 1 Astellas Way, Northbrook, IL 60062, United States.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Cywin', 'Affiliation': 'Astellas Pharma, Inc., 1 Astellas Way, Northbrook, IL 60062, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kovanda', 'Affiliation': 'Astellas Pharma, Inc., 1 Astellas Way, Northbrook, IL 60062, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Van Sant', 'Affiliation': 'Astellas Pharma, Inc., 1 Astellas Way, Northbrook, IL 60062, United States.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Malinoski', 'Affiliation': 'Affinivax, 301 Binney St, Cambridge, MA 02142, United States.'}, {'ForeName': 'Shite', 'Initials': 'S', 'LastName': 'Sebastian', 'Affiliation': 'Affinivax, 301 Binney St, Cambridge, MA 02142, United States.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Siber', 'Affiliation': 'Affinivax, 301 Binney St, Cambridge, MA 02142, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Malley', 'Affiliation': 'Affinivax, 301 Binney St, Cambridge, MA 02142, United States.'}]",Vaccine,['10.1016/j.vaccine.2022.05.079']
1655,35691037,Acupuncture for female bladder pain syndrome: a randomized controlled trial.,"INTRODUCTION


Growing evidence supports acupuncture for several pain conditions including chronic prostatitis. This study aimed to determine the safety, tolerability, and effectiveness of acupuncture in reducing pain in women with interstitial cystitis/bladder pain syndrome (IC/BPS).
MATERIALS AND METHODS


This prospective randomized single-blinded study compared electro-acupuncture (EA) to minimal acupuncture (MA) after 6 weekly treatments and again after 6 weeks of no treatment. Pain was assessed using the Brief Pain Inventory-Short Form (worst pain, average pain, pain severity, pain interference) and the Pain Catastrophizing Scale (PCS). Physical exams evaluated pelvic floor muscle tenderness. Mixed-effects models were used to estimate adjusted means over follow up.
RESULTS


Patients were randomized to EA (n = 11) or MA (n = 10). There were no adverse events. Both groups' worst pain improved at 6 weeks, -2.91 ± 0.59 and -2.09 ± 0.68 for EA and MA respectively with no difference between groups (p = 0.37). Results were similar at 12 weeks. The EA group had greater improvement in pain interference at 6 weeks, -3.28 ± 0.51 versus -1.67 ± 0.58 (p = 0.049). The between group difference was not maintained at 12 weeks (p = 0.13). Average pain and pain severity showed no difference between groups (p > 0.05). The PCS improved overall at 6 weeks, -6.2 ± 2.5 (p = 0.03), with no difference between groups (p = 0.39). On physical exam, only the EA group showed a significant decrease in levator ani tenderness (p = 0.031) after treatment.
CONCLUSIONS


Both EA and MA showed improvement in worst pain scores, however EA showed greater improvement in pain interference and pelvic floor muscle tenderness in women with IC/BPS.",2022,"Both EA and MA showed improvement in worst pain scores, however EA showed greater improvement in pain interference and pelvic floor muscle tenderness in women with IC/BPS.","['women with interstitial cystitis/bladder pain syndrome (IC/BPS', 'female bladder pain syndrome']","['Acupuncture', 'electro-acupuncture (EA) to minimal acupuncture (MA', 'EA', 'acupuncture', 'MA']","['Brief Pain Inventory-Short Form (worst pain, average pain, pain severity, pain interference) and the Pain Catastrophizing Scale (PCS', 'Physical exams evaluated pelvic floor muscle tenderness', 'worst pain scores', 'pain', 'worst pain', 'pain interference and pelvic floor muscle tenderness', 'levator ani tenderness', 'pain interference', 'Average pain and pain severity', 'Pain', 'safety, tolerability, and effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0240419', 'cui_str': 'Tender muscles'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0224384', 'cui_str': 'Structure of levator ani muscle'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.125937,"Both EA and MA showed improvement in worst pain scores, however EA showed greater improvement in pain interference and pelvic floor muscle tenderness in women with IC/BPS.","[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Bresler', 'Affiliation': 'Department of Urology, Loyola University Chicago Stritch School of Medicine, Maywood, Illinois, USA.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Westbay', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Loyola University Chicago Stritch School of Medicine, Maywood, Illinois, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hekman', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, Illinois, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Joyce', 'Affiliation': 'Department of Medicine, Loyola University Chicago, Maywood, Illinois, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Loyola University Chicago Stritch School of Medicine, Maywood, Illinois, USA.'}]",The Canadian journal of urology,[]
1656,35691326,"Short versus extended treatment with a carbapenem in patients with high-risk fever of unknown origin during neutropenia: a non-inferiority, open-label, multicentre, randomised trial.","BACKGROUND


Early antibiotic discontinuation has been advocated in haematology patients with fever of unknown origin during chemotherapy-induced neutropenia, but its safety is unknown. We aimed to assess if short treatment with carbapenems is non-inferior to extended treatment.
METHODS


This non-inferiority, open-label, multicentre, randomised trial was done in six hospitals in the Netherlands. Adult patients (≥18 years) who were treated with intensive chemotherapy or haematopoietic stem-cell transplantation (HSCT) for a haematological malignancy, and had fever of unknown origin during high-risk neutropenia (<0·5 × 10 9 /L expected for ≥7 days) were eligible. After onset of fever, patients received either 500 mg intravenous imipenem-cilastatin four times a day or 1000 mg intravenous meropenem three times a day. Between 48 h and 72 h of treatment, participants were randomly assigned (1:1) by a computer-generated sequence to receive a short-term (72 h [60-84]; short treatment group) or extended (≥9 days until being afebrile for 5 days or neutrophil recovery; extended treatment group) carbapenem regimen. The composite primary endpoint was treatment failure, defined as recurrent fever or a carbapenem-sensitive infection between day 4 and day 9 and septic shock or respiratory failure or death from day 4 until neutrophil recovery. The study was designed to assess the non-inferiority of the short treatment compared with the extended treatment regimen, with a non-inferiority margin of 10%. The primary outcome was adjudicated by an independent outcome committee, who were masked to treatment allocation, and was analysed in the intention-to-treat and per-protocol populations. The trial is completed and registered with ClinicalTrials.gov, NCT02149329.
FINDINGS


Between Dec 1, 2014, and July 1, 2019, 281 patients were included in the intention-to-treat analysis: 144 (51%) patients were assigned to the short treatment group and 137 (49%) to the extended treatment group. Median age was 59 years (IQR 52-65); 109 (39%) patients were women and 172 (61%) were men; 205 (73%) patients received HSCT. In the intention-to-treat analysis, 28 (19%) of 144 patients in the short treatment group versus 21 (15%) of 137 patients in the extended treatment group had treatment failure (adjusted risk difference [ARD] 4·0% [90% CI -1·7% to 9·7%]; p=0·25). In the per-protocol analysis (n=225), 24 (23%) of 104 patients in the short treatment group and 19 (16%) of 121 patients in the extended treatment group had treatment failure (ARD 7·3% [0·3% to 14·9%]; p=0·11). The most common grade 3-5 infection-related adverse events were mucositis (23 [20%] of 114 adverse events in the short treatment group vs 28 [29%] of 98 adverse events in the extended treatment group), fever of unknown origin (20 [18%] vs 16 [16%] events), and bacteraemia (15 [13%] vs 13 [13%] events). The number of serious adverse events were higher in the short treatment group (23 [16%] of 144 patients) than in the extended treatment group (14 [10%] of 137 patients), due to an increased rate of readmission (17 [12%] patients in the short treatment group vs ten [7%] in the extended treatment group). Death before 30 days after neutrophil recovery occurred in five (3%) participants in the short treatment group: two due to progressive leukaemia, two due to candidaemia, and one due to Enterococcus faecium bacteraemia and drug-induced pneumonitis. One (1%) patient died in the extended treatment group due to candidaemia. None of the deaths were related to carbapenem-sensitive infections.
INTERPRETATION


Early discontinuation of carbapenem treatment in patients with febrile neutropenia of unknown origin does not result in increased treatment failure. Our study supports short treatment if patients are afebrile after 3 days of carbapenem treatment. However, because secondary analyses suggested that serious adverse events and all-cause mortality occurred more often in patients who are presistantly febrile the short treatment group, we recommend vigilance for non-susceptible pathogens and early resumption of empirical therapy in patients who are deteriorating.
FUNDING


The Netherlands Organisation for Health Research and Development and Fonds NutsOhra.",2022,"The number of serious adverse events were higher in the short treatment group (23 [16%] of 144 patients) than in the extended treatment group (14 [10%] of 137 patients), due to an increased rate of readmission (17 [12%] patients in the short treatment group vs ten [7%] in the extended treatment group).","['six hospitals in the Netherlands', 'Between Dec 1, 2014, and July 1, 2019', 'patients with high-risk fever of unknown origin during neutropenia', 'haematology patients with fever of unknown origin during chemotherapy-induced neutropenia', 'Adult patients (≥18 years) who were treated with intensive chemotherapy or haematopoietic stem-cell transplantation (HSCT) for a haematological malignancy, and had fever of unknown origin during high-risk neutropenia (<0·5', '281 patients were included in the intention-to-treat analysis: 144 (51', 'patients with febrile neutropenia of unknown origin', 'Median age was 59 years (IQR 52-65); 109 (39%) patients were women and 172 (61%) were men; 205 (73%) patients received']","['HSCT', 'imipenem-cilastatin', 'carbapenem', 'carbapenem regimen', 'carbapenems']","['treatment failure, defined as recurrent fever or a carbapenem-sensitive infection between day 4 and day 9 and septic shock or respiratory failure or death from day 4 until neutrophil recovery', 'mucositis', 'bacteraemia', 'neutrophil recovery', 'rate of readmission', 'treatment failure', 'number of serious adverse events', 'fever of unknown origin', 'Death']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015970', 'cui_str': 'Pyrexia of unknown origin'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1274119', 'cui_str': 'Hematopathology'}, {'cui': 'C1827687', 'cui_str': 'Chemotherapy-induced neutropenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0071972', 'cui_str': 'imipenem and cilastatin'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035021', 'cui_str': 'Relapsing fever'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015970', 'cui_str': 'Pyrexia of unknown origin'}]",281.0,0.376084,"The number of serious adverse events were higher in the short treatment group (23 [16%] of 144 patients) than in the extended treatment group (14 [10%] of 137 patients), due to an increased rate of readmission (17 [12%] patients in the short treatment group vs ten [7%] in the extended treatment group).","[{'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'de Jonge', 'Affiliation': 'Department of Haematology, Amsterdam University Medical Centres, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. Electronic address: ni.dejonge@amsterdamumc.nl.'}, {'ForeName': 'Jonne J', 'Initials': 'JJ', 'LastName': 'Sikkens', 'Affiliation': 'Department of Internal Medicine, Amsterdam University Medical Centres, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Haematology, Amsterdam University Medical Centres, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, Netherlands.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ypma', 'Affiliation': 'Department of Internal Medicine, Haga Hospital, The Hague, Netherlands.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Herbers', 'Affiliation': 'Department of Internal Medicine, Jeroen Bosch Hospital, Den Bosch, Netherlands.'}, {'ForeName': 'Wies', 'Initials': 'W', 'LastName': 'Vasmel', 'Affiliation': 'Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'de Kreuk', 'Affiliation': 'Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Juleon L L M', 'Initials': 'JLLM', 'LastName': 'Coenen', 'Affiliation': 'Department of Internal Medicine, Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Department of Internal Medicine, Amsterdam University Medical Centres, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Michiel A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Department of Internal Medicine, Amsterdam University Medical Centres, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jeroen J W M', 'Initials': 'JJWM', 'LastName': 'Janssen', 'Affiliation': 'Department of Haematology, Amsterdam University Medical Centres, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",The Lancet. Haematology,['10.1016/S2352-3026(22)00145-4']
1657,35691324,"Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial.","BACKGROUND


Vaccination of children and young people against SARS-CoV-2 is recommended in some countries. Scarce data have been published on immune responses induced by COVID-19 vaccines in people younger than 18 years compared with the same data that are available in adults.
METHODS


COV006 is a phase 2, single-blind, randomised, controlled trial of ChAdOx1 nCoV-19 (AZD1222) in children and adolescents at four trial sites in the UK. Healthy participants aged 6-17 years, who did not have a history of chronic respiratory conditions, laboratory-confirmed COVID-19, or previously received capsular group B meningococcal vaccine (the control), were randomly assigned to four groups (4:1:4:1) to receive two intramuscular doses of 5 × 10 10  viral particles of ChAdOx1 nCoV-19 or control, 28 days or 84 days apart. Participants, clinical investigators, and the laboratory team were masked to treatment allocation. Study groups were stratified by age, and participants aged 12-17 years were enrolled before those aged 6-11 years. Due to the restrictions in the use of ChAdOx1 nCoV-19 in people younger than 30 years that were introduced during the study, only participants aged 12-17 years who were randomly assigned to the 28-day interval group had received their vaccinations at the intended interval (day 28). The remaining participants received their second dose at day 112. The primary outcome was assessment of safety and tolerability in the safety population, which included all participants who received at least one dose of the study drug. The secondary outcome was immunogenicity, which was assessed in participants who were seronegative to the nucleocapsid protein at baseline and received both prime and boost vaccine. This study is registered with ISRCTN (15638344).
FINDINGS


Between Feb 15 and April 2, 2021, 262 participants (150 [57%] participants aged 12-17 years and 112 [43%] aged 6-11 years; due to the change in the UK vaccination policy, the study terminated recruitment of the younger age group before the planned number of participants had been enrolled) were randomly assigned to receive vaccination with two doses of either ChAdOx1 nCoV-19 (n=211 [n=105 at day 28 and n=106 at day 84]) or control (n=51 [n=26 at day 28 and n=25 at day 84]). One participant in the ChAdOx1 nCoV-19 day 28 group in the younger age bracket withdrew their consent before receiving a first dose. Of the participants who received ChAdOx1 nCoV-19, 169 (80%) of 210 participants reported at least one solicited local or systemic adverse event up to 7 days following the first dose, and 146 (76%) of 193 participants following the second dose. No serious adverse events related to ChAdOx1 nCoV-19 administration were recorded by the data cutoff date on Oct 28, 2021. Of the participants who received at least one dose of ChAdOx1 nCoV-19, there were 128 unsolicited adverse events up to 28 days after vaccination reported by 83 (40%) of 210 participants. One participant aged 6-11 years receiving ChAdOx1 nCoV-19 reported a grade 4 fever of 40·2°C on day 1 following first vaccination, which resolved within 24 h. Pain and tenderness were the most common local solicited adverse events for all the ChAdOx1 nCoV-19 and capsular group B meningococcal groups following both doses. Of the 242 participants with available serostatus data, 14 (6%) were seropositive at baseline. Serostatus data were not available for 20 (8%) of 262 participants. Among seronegative participants who received ChAdOx1 nCoV-19, anti-SARS-CoV-2 IgG and pseudoneutralising antibody titres at day 28 after the second dose were higher in participants aged 12-17 years with a longer interval between doses (geometric means of 73 371 arbitrary units [AU]/mL [95% CI 58 685-91 733] and 299 half-maximal inhibitory concentration [IC 50 ; 95% CI 230-390]) compared with those aged 12-17 years who received their vaccines 28 days apart (43 280 AU/mL [95% CI 35 852-52 246] and 150 IC 50  [95% CI 116-194]). Humoral responses were higher in those aged 6-11 years than in those aged 12-17 years receiving their second dose at the same 112-day interval (geometric mean ratios 1·48 [95% CI 1·07-2·07] for anti-SARS-CoV-2 IgG and 2·96 [1·89-4·62] for pseudoneutralising antibody titres). Cellular responses peaked after a first dose of ChAdOx1 nCoV-19 across all age and interval groups and remained above baseline after a second vaccination.
INTERPRETATION


ChAdOx1 nCoV-19 is well tolerated and immunogenic in children aged 6-17 years, inducing concentrations of antibody that are similar to those associated with high efficacy in phase 3 studies in adults. No safety concerns were raised in this trial.
FUNDING


AstraZeneca and the UK Department of Health and Social Care through the UK National Institute for Health and Care Research.",2022,Humoral responses were higher in those aged 6-11 years than in those aged 12-17 years receiving their second dose at the same 112-day interval (geometric mean ratios 1·48 [95% CI 1·07-2·07] for anti-SARS-CoV-2 IgG and 2·96 [1·89-4·62] for pseudoneutralising antibody titres).,"['Study groups were stratified by age, and participants aged 12-17 years were enrolled before those aged 6-11 years', 'children aged 6-17 years', 'Healthy participants aged 6-17 years, who did not have a history of chronic respiratory conditions, laboratory-confirmed COVID-19, or previously received capsular group B meningococcal vaccine (the control', 'One participant aged 6-11 years receiving', '262 participants (150 [57%] participants aged 12-17 years and 112 [43%] aged 6-11 years; due to the change in the UK vaccination policy, the study terminated recruitment of the younger age group before the planned number of participants had been enrolled', 'people younger than 30 years that were introduced during the study, only participants aged 12-17 years', 'seronegative participants who received', 'people younger than 18 years', 'children and adolescents at four trial sites in the UK', '242 participants with available serostatus data, 14 (6%) were seropositive at baseline']","['ChAdOx1 nCoV-19, anti-SARS-CoV-2 IgG', 'ChAdOx1 nCoV-19', 'ChAdOx1 nCoV-19 (AZD1222', 'control', 'vaccination with two doses of either ChAdOx1 nCoV-19', 'ChAdOx1 nCoV-19 (AZD1222) vaccine']","['Cellular responses', 'solicited local or systemic adverse event', 'Humoral responses', 'safety and tolerability', 'Safety and immunogenicity']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",242.0,0.705332,Humoral responses were higher in those aged 6-11 years than in those aged 12-17 years receiving their second dose at the same 112-day interval (geometric mean ratios 1·48 [95% CI 1·07-2·07] for anti-SARS-CoV-2 IgG and 2·96 [1·89-4·62] for pseudoneutralising antibody titres).,"[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Cappuccini', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK; Jenner Institute, University of Oxford, Old Road Campus, Oxford, UK.'}, {'ForeName': 'Natalie G', 'Initials': 'NG', 'LastName': 'Marchevsky', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Anslow', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Cathie', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': ""Vaccine Institute, St George's, University of London and St George's University Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kerridge', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Lelliott', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Yama', 'Initials': 'Y', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Khuen Foong', 'Initials': 'KF', 'LastName': 'Ng', 'Affiliation': 'Bristol Royal Hospital for Children, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rhead', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Marion R', 'Initials': 'MR', 'LastName': 'Roderick', 'Affiliation': 'Bristol Royal Hospital for Children, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Rinn', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Karly', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Yao', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK. Electronic address: xinxue.liu@paediatrics.ox.ac.uk.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK; Chinese Academy of Medical Science Oxford Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(22)00770-X']
1658,35691295,"Safety and immunogenicity of the FINLAY-FR-1A vaccine in COVID-19 convalescent participants: an open-label phase 2a and double-blind, randomised, placebo-controlled, phase 2b, seamless, clinical trial.","BACKGROUND


A phase 1, clinical trial to evaluate FINLAY-FR-1A vaccine in COVID-19 convalescent individuals was completed. Here, we report results of the phase 2, clinical trial.
METHODS


We studied 450 convalescent participants with a history of asymptomatic, mild, or moderate COVID-19 at the National Institute of Hematology and Immunology and the National Centre for Sexual Education in Havana, Cuba. The study included adults aged 19-78 years who had recovered from COVID-19 and had had a negative PCR test at least 2 months before the initiation of the study. Phase 2 was done sequentially in two stages. The first stage to assess safety comprised an open, non-controlled phase 2a study in participants aged 60-78 years who received a single dose of the FINLAY-FR-1A vaccine (50 μg of recombinant dimeric receptor binding domain [RBD]). The second stage comprised the placebo-controlled, double-blind, phase 2b trial in participants aged 19-78 years, where participants were randomly assigned (4:1) into two groups: an experimental group vaccinated with a single dose of the FINLAY-FR-1A vaccine, and a control (placebo) group injected with vaccine excipient. The primary outcomes were safety, evaluated 28 days after vaccination by the occurrence of serious adverse events in all participants, and successful immune response, assessed by neutralising antibody ELISA, and defined as half-maximal surrogate virus neutralisation titres of 250 or more. Secondary endpoints included vaccine immunogenicity assessed by ELISA anti-RBD and live-virus neutralisation test. All randomly assigned participants were included in the safety analysis (safety population), and immunogenicity was evaluated in participants without study interruptions (per-protocol population). The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000366-En and WHO-ICTRP and is complete.
FINDINGS


From April 9, 2021, to April 17, 2021, 663 COVID-19 convalescent participants were enrolled in the study; 213 participants did not meet the selection criteria and 450 volunteers were recruited. 20 participants aged 60-78 years were included in the open, single-group, phase 2a study and 430 participants were randomly assigned to the experimental (n=344) or control groups (n=86) in the phase 2b study of participants aged 19-78 years. 19 (95%) of 20 phase 2a volunteers achieved a successful immune response after vaccination. No vaccine-associated serious adverse events were reported in the whole study population. Minor adverse events were found, the most common being pain at the injection site (105 [29%] of 364 in the intervention group; 13 [15%] of 86 in the placebo group). A successful immune response was found in 289 (81%) of 358 participants 28 days after vaccination. The vaccine elicited a greater than 31-times increase in anti-RBD-IgG antibodies compared with prevaccination rates, and the seroconversion rate was 302 (84%) of 358 on day 28 after vaccination; the geometric mean titres of live-virus neutralisation test increased from 15·4 (95% CI 10·3-23·2) to 400·3 (272·4-588·1) and high response was found against alpha, beta, and delta variants of concern.
INTERPRETATION


A single dose of the FINLAY-FR-1A vaccine against SARS-CoV-2 strengthened the pre-existing natural immunity, with excellent safety profile.
FUNDING


Cuba's Ministry of Science, Technology, and Environment.",2022,"The vaccine elicited a greater than 31-times increase in anti-RBD-IgG antibodies compared with prevaccination rates, and the seroconversion rate was 302 (84%) of 358 on day 28 after vaccination; the geometric mean titres of live-virus neutralisation test increased from 15·4 (95% CI 10·3-23·2) to 400·3 (272·4-588·1) and high response was found against alpha, beta, and delta variants of concern.
","['adults aged 19-78 years who had recovered from COVID-19 and had had a negative PCR test at least 2 months before the initiation of the study', 'participants aged 19-78 years', '20 participants aged 60-78 years were included in the open, single-group, phase 2a study and 430 participants were randomly assigned to the experimental (n=344) or control groups (n=86) in the phase 2b study of participants aged 19-78 years', 'participants aged 60-78 years who received a single dose of the', '450 convalescent participants with a history of asymptomatic, mild, or moderate COVID-19 at the National Institute of Hematology and Immunology and the National Centre for Sexual Education in Havana, Cuba', 'COVID-19 convalescent participants', 'COVID-19 convalescent individuals', 'From April 9, 2021, to April 17, 2021, 663 COVID-19 convalescent participants were enrolled in the study; 213 participants did not meet the selection criteria and 450 volunteers were recruited']","['FINLAY-FR-1A vaccine (50 μg of recombinant dimeric receptor binding domain [RBD', 'FINLAY-FR-1A vaccine', 'vaccine excipient', 'experimental group vaccinated with a single dose of the FINLAY-FR-1A vaccine, and a control (placebo', 'placebo']","['anti-RBD-IgG antibodies', 'occurrence of serious adverse events', 'serious adverse events', 'successful immune response, assessed by neutralising antibody ELISA, and defined as half-maximal surrogate virus neutralisation titres', 'seroconversion rate', 'vaccine immunogenicity assessed by ELISA anti-RBD and live-virus neutralisation test', 'successful immune response', 'geometric mean titres of live-virus neutralisation test', 'Safety and immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010435', 'cui_str': 'Cuba'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C5197683', 'cui_str': 'Excipient, Vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C4277607', 'cui_str': 'Antigenicity, Vaccine'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",450.0,0.658251,"The vaccine elicited a greater than 31-times increase in anti-RBD-IgG antibodies compared with prevaccination rates, and the seroconversion rate was 302 (84%) of 358 on day 28 after vaccination; the geometric mean titres of live-virus neutralisation test increased from 15·4 (95% CI 10·3-23·2) to 400·3 (272·4-588·1) and high response was found against alpha, beta, and delta variants of concern.
","[{'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Ochoa-Azze', 'Affiliation': 'Finlay Vaccine Institute, Atabey, Playa, Havana, Cuba. Electronic address: ochoa@finlay.edu.cu.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Chang-Monteagudo', 'Affiliation': 'National Institute of Hematology and Immunology, Vedado, Havana, Cuba.'}, {'ForeName': 'Yanet', 'Initials': 'Y', 'LastName': 'Climent-Ruiz', 'Affiliation': 'Finlay Vaccine Institute, Atabey, Playa, Havana, Cuba.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Macías-Abraham', 'Affiliation': 'National Institute of Hematology and Immunology, Vedado, Havana, Cuba.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Valenzuela-Silva', 'Affiliation': 'Institute of Cybernetics, Mathematics and Physics, Vedado, Havana, Cuba.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'de Los Ángeles García-García', 'Affiliation': 'National Institute of Hematology and Immunology, Vedado, Havana, Cuba.'}, {'ForeName': 'Yanet', 'Initials': 'Y', 'LastName': 'Jerez-Barceló', 'Affiliation': 'National Institute of Hematology and Immunology, Vedado, Havana, Cuba.'}, {'ForeName': 'Yenisey', 'Initials': 'Y', 'LastName': 'Triana-Marrero', 'Affiliation': 'National Institute of Hematology and Immunology, Vedado, Havana, Cuba.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ruiz-Villegas', 'Affiliation': 'National Institute of Hematology and Immunology, Vedado, Havana, Cuba.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Dairon Rodríguez-Prieto', 'Affiliation': 'National Institute of Hematology and Immunology, Vedado, Havana, Cuba.'}, {'ForeName': 'Pedro Pablo', 'Initials': 'PP', 'LastName': 'Guerra-Chaviano', 'Affiliation': 'National Coordinating Centre of Clinical Trials, Miramar, Playa, Havana, Cuba.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Sánchez-Ramírez', 'Affiliation': 'Centre of Molecular Immunology, Siboney, Playa, Havana, Cuba.'}, {'ForeName': 'Tays', 'Initials': 'T', 'LastName': 'Hernández-García', 'Affiliation': 'Centre of Molecular Immunology, Siboney, Playa, Havana, Cuba.'}, {'ForeName': 'Ivette', 'Initials': 'I', 'LastName': 'Orosa-Vázquez', 'Affiliation': 'Centre of Molecular Immunology, Siboney, Playa, Havana, Cuba.'}, {'ForeName': 'Marianniz', 'Initials': 'M', 'LastName': 'Díaz-Hernández', 'Affiliation': 'Centre of Molecular Immunology, Siboney, Playa, Havana, Cuba.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Chiodo', 'Affiliation': 'Finlay Vaccine Institute, Atabey, Playa, Havana, Cuba; Department of Molecular Cell Biology and Immunology, Amsterdam UMC, Vrije Universiteit Amsterdam, Netherlands and Institute of Biomolecular Chemistry, National Research Council, Pozzuoli, Napoli, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Calcagno', 'Affiliation': 'Unit of Infectious Diseases, Department of Medical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Ghisetti', 'Affiliation': 'Laboratory of Microbiology and Virology, Amedeo di Savoia Hospital, ASL, Turin, Italy.'}, {'ForeName': 'Mireida', 'Initials': 'M', 'LastName': 'Rodríguez-Acosta', 'Affiliation': 'Research Centre of Civil Defence, San José de las Lajas, Mayabeque, Cuba.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Noa-Romero', 'Affiliation': 'Research Centre of Civil Defence, San José de las Lajas, Mayabeque, Cuba.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Enríquez-Puertas', 'Affiliation': 'Research Centre of Civil Defence, San José de las Lajas, Mayabeque, Cuba.'}, {'ForeName': 'Darién', 'Initials': 'D', 'LastName': 'Ortega-León', 'Affiliation': 'Immunoassay Centre, Cubanacán, Playa, Havana, Cuba.'}, {'ForeName': 'Irinia', 'Initials': 'I', 'LastName': 'Valdivia-Álvarez', 'Affiliation': 'Immunoassay Centre, Cubanacán, Playa, Havana, Cuba.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Delahanty-Fernández', 'Affiliation': 'Immunoassay Centre, Cubanacán, Playa, Havana, Cuba.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Palenzuela-Díaz', 'Affiliation': 'Immunoassay Centre, Cubanacán, Playa, Havana, Cuba.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rodríguez-Noda', 'Affiliation': 'Finlay Vaccine Institute, Atabey, Playa, Havana, Cuba.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'González-Mugica', 'Affiliation': 'Finlay Vaccine Institute, Atabey, Playa, Havana, Cuba.'}, {'ForeName': 'Yury', 'Initials': 'Y', 'LastName': 'Valdés-Balbín', 'Affiliation': 'Finlay Vaccine Institute, Atabey, Playa, Havana, Cuba.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'García-Rivera', 'Affiliation': 'Finlay Vaccine Institute, Atabey, Playa, Havana, Cuba.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Verez-Bencomo', 'Affiliation': 'Finlay Vaccine Institute, Atabey, Playa, Havana, Cuba.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(22)00100-X']
1659,35691288,Changes in Psychological Determinants of Behavior Change after Individual versus Group-Based Lifestyle-integrated Fall Prevention: Results from the LiFE-is-LiFE Trial.,"OBJECTIVE


The Lifestyle-integrated Functional Exercise (LiFE) intervention has been shown to promote physical activity in fall-prone older adults. However, the underlying mechanisms of how LiFE functions remain unclear. This study compares the effects of the individual and group-based LiFE formats on psychological determinants of behavior change derived from the health action process approach, habit formation theory, and self-determination theory.
METHODS


Secondary analysis on basis of the randomized, non-inferiority LiFE-is-LiFE trial were performed. Questionnaire data on psychological determinants were obtained from older adults (M = 78.8 years, range 70-95) who took part in either the individual (n = 156) or the group-based (n = 153) LiFE intervention. Measurement points varied from three to six times, and from baseline (T1) up to a 12-month follow-up (T6). A generalized linear mixed model was specified for each determinant.
RESULTS


Both LiFE and gLiFE participants reported lower levels of motivational determinants at T6. LiFE participants showed significantly higher values of action planning and coping planning at T6. Participants in both formats showed increased levels of action control at T6, whereas participants' habit strength decreased post-intervention but then stabilized over time. LiFE participants showed higher levels of autonomy, competence, and relatedness throughout the study, but levels of intrinsic motivation did not differ between formats and from T1 to T6.
CONCLUSION


In both formats, but especially in the individual LiFE, the behavior change techniques used affected volitional rather than motivational or general determinants of behavior change. Habit strength as an important indicator of the sustainability of the LiFE exercises stabilized over time, indicating that participants, at least partly, sustained their formed habits long-term.",2022,"Participants in both formats showed increased levels of action control at T6, whereas participants' habit strength decreased post-intervention but then stabilized over time.","['fall-prone older adults', 'older adults (M = 78.8 years, range 70-95) who took part in either the individual (n = 156) or the group-based (n = 153) LiFE intervention']","['Lifestyle-integrated Functional Exercise (LiFE) intervention', 'individual and group-based LiFE formats', 'gLiFE']","['levels of motivational determinants', 'habit strength', 'intrinsic motivation', 'Psychological Determinants of Behavior Change', 'levels of action control', 'levels of autonomy, competence, and relatedness']","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0278611,"Participants in both formats showed increased levels of action control at T6, whereas participants' habit strength decreased post-intervention but then stabilized over time.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Labudek', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Fleig', 'Affiliation': 'Department of Psychology, MSB Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Carl-Philipp', 'Initials': 'CP', 'LastName': 'Jansen', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Kramer-Gmeiner', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Nerz', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Klenk', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwenk', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany.'}]",Gerontology,['10.1159/000524701']
1660,35695781,Interdisciplinary Model-Informed Drug Development for Extending Duration of Elagolix Treatment in Patients with Uterine Fibroids.,"AIM


Elagolix, a gonadotropin-releasing hormone receptor antagonist, was recently approved for heavy menstrual bleeding associated with uterine fibroids (UF, Oriahnn™) at a dose of 300 mg twice daily (BID) in combination with add-back therapy (estradiol 1 mg/norethindrone acetate 0.5 mg [E2/NETA] once daily) for 24 months use. The limited duration of treatment is related to elagolix dose- and duration-dependent decrease in estrogen that is mechanistically linked to changes in bone mineral density (BMD). The work herein supported the extended treatment duration of 24 months.
METHODS


An integrated exposure-response and epidemiological modeling framework of elagolix effects on femoral neck BMD (FN-BMD), informed by real-world data and phase 3 clinical trials data, was developed to predict the time course and magnitude of changes in BMD and its relation to risk of bone fracture in women with UF.
RESULTS


Model results indicated that women treated with elagolix 300 mg BID + E2/NETA for long term (i.e., >24 months) may experience less than 1% loss in FN-BMD per year, relative to placebo. The exposure-response model simulations and clinical risk factors were used to estimate 10-year risk of fractures using the clinically validated Fracture Risk Assessment Tool (FRAX®). The impact of elagolix 300 mg BID + E2/NETA treatment on the 10-year risk of hip or major osteoporotic fractures estimated from the FRAX® model was minimal compared to placebo.
CONCLUSION


The elagolix integrated exposure-BMD analysis and translation to fracture risk provided an interdisciplinary model-informed drug development framework for clinical benefit-risk evaluation and enabled approval of longer treatment duration to benefit the patient.",2022,"The impact of elagolix 300 mg BID + E2/NETA treatment on the 10-year risk of hip or major osteoporotic fractures estimated from the FRAX® model was minimal compared to placebo.
","['women with UF', 'Patients with Uterine Fibroids']","['gonadotropin-releasing hormone receptor antagonist', 'norethindrone acetate 0.5 mg [E2/NETA', 'combination with add-back therapy (estradiol', 'elagolix 300 mg BID + E2/NETA']","['bone mineral density (BMD', 'femoral neck BMD (FN-BMD', '10-year risk of hip or major osteoporotic fractures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C3282435', 'cui_str': 'norethindrone acetate 0.5 MG'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}]",,0.0828424,"The impact of elagolix 300 mg BID + E2/NETA treatment on the 10-year risk of hip or major osteoporotic fractures estimated from the FRAX® model was minimal compared to placebo.
","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Beck', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.'}, {'ForeName': 'Insa', 'Initials': 'I', 'LastName': 'Winzenborg', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Analysis Group, Boston, United States.'}, {'ForeName': 'Nael M', 'Initials': 'NM', 'LastName': 'Mostafa', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, United States.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Chiuve', 'Affiliation': 'Global Epidemiology, AbbVie, North Chicago, IL, United States.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Owens', 'Affiliation': 'Clinical Development, General Medicine, AbbVie, North Chicago, IL, United States.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Shebley', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, United States.'}]",British journal of clinical pharmacology,['10.1111/bcp.15440']
1661,35695753,Influence of height on ED95 of intrathecal 2-chloroprocaine for knee arthroscopy: A prospective dose-response clinical trial.,"BACKGROUND


Plain 2-chloroprocaine , a rapid acting amino-ester-type local anaesthetic, is used in short ambulatory procedures under spinal anaesthesia. The ED95 of 2-chloroprocaine for lower limb surgery has not yet been defined. Moreover, patients' body height could influence the effects of the administered dose.
OBJECTIVES


The aim of this study was to determine the ED95 of plain 2-chloroprocaine based on the height of patients undergoing ambulatory knee arthroscopy under spinal anaesthesia using the continual reassessment statistical method (CRM).
DESIGN


prospective, dose-response, double blind, controlled, bi-center, clinical trial.
SETTING


One university teaching hospital in Brussels and one general teaching hospital, Braine l'Alleud, Belgium. Université libre de Bruxelles.
PATIENTS


ASA I-III (120 patients) scheduled for day-case knee arthroscopy under spinal anaesthesia.
INTERVENTIONS


Patients were divided into three groups of 40, each comprising 10 cohorts of 4 patients, according to their respective heights (Group 1: 150-165 cm, Group 2: 166-180 cm, Group 3: 181-195 cm). Each patient enrolled into one of the 3 groups received an intrathecal dose of plain 2-chloroprocaine determined by the CRM. The starting doses for the first cohorts of four were 40 mg in group 1, 45 mg in group 2 and 50 mg in group 3. The doses for subsequent cohorts were determined by CRM of outcomes in all patients in the previous competed cohorts. Anaesthesia was considered successful when there was a lack of pinprick or cold sensation up to T12, the visual analogue scale score for tourniquet pain was < 2 and no pain during surgery.
MAIN OUTCOMES


The primary outcome was the success or failure of the block. Side effects were also recorded.
RESULTS


ED95 of 2-chloroprocaine is 40 mg in group 1, 35 mg in group 2, 45 mg in group 3. Groups were different in terms of height and gender (P < 0.05) and similar in terms of body mass index and age (P > 0.05).
CONCLUSION


The ED95 of intrathecal 2-chloroprocaine for patients undergoing ambulatory knee arthroscopy is between 35 and 45 mg. Height could be a factor involved in the calculation, and patient sex could partly explain the nonlinear relation between height and dose.
TRIAL REGISTRY NUMBER


Clinicaltrials.gov NCT03882489.",2022,"Groups were different in terms of height and gender (P < 0.05) and similar in terms of body mass index and age (P > 0.05).
","['patients undergoing ambulatory knee arthroscopy is between 35 and 45\u200amg', 'patients undergoing ambulatory knee arthroscopy under spinal anaesthesia using the continual reassessment statistical method (CRM', 'knee arthroscopy', 'ASA I-III (120 patients) scheduled for day-case knee arthroscopy under spinal anaesthesia', ""One university teaching hospital in Brussels and one general teaching hospital, Braine l'Alleud, Belgium""]","['2-chloroprocaine', 'intrathecal dose of plain 2-chloroprocaine determined by the CRM', 'Plain 2-chloroprocaine', 'plain 2-chloroprocaine', 'intrathecal 2-chloroprocaine']","['success or failure of the block', 'visual analogue scale score for tourniquet pain', 'pinprick or cold sensation', 'Side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee joint'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0439598', 'cui_str': 'Continual'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0439598', 'cui_str': 'Continual'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234192', 'cui_str': 'Cold'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0605131,"Groups were different in terms of height and gender (P < 0.05) and similar in terms of body mass index and age (P > 0.05).
","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Guntz', 'Affiliation': ""From the Department of Anaesthesia, Hôpital de Braine l'Alleud Waterloo, 35 rue Wayez, 1420 Braine l'Alleud-Waterloo, Université Libre de Bruxelles (ULB), Belgium (EG, JGa, JGo), Department of Anaesthesia, University Hospital Saint Pierre, Bruxelles, ULB, Belgium (MM, YK), Department of Anaesthesia, CHU de Charleroi, Charleroi, ULB, Belgium (SS) and Ars Statistica Private Statistic Society (S.P.R.L). Nivelles (J-FF).""}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Jeanne', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gouwy', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': ""M'rini"", 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': ''}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Fils', 'Affiliation': ''}, {'ForeName': 'Yota', 'Initials': 'Y', 'LastName': 'Kapessidou', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001692']
1662,35695720,"Paliperidone Extended Release Versus Olanzapine in Treatment-Resistant Schizophrenia: A Randomized, Double-Blind, Multicenter Study.","PURPOSE


Paliperidone is an atypical antipsychotic as effective as other atypical antipsychotics for schizophrenia. However, few studies have explored the efficacy of paliperidone for treatment-resistant schizophrenia. This study aimed to compare the efficacy and safety of paliperidone extended release (ER) versus olanzapine in schizophrenia patients with either poor treatment response or intolerable adverse effects due to standardized antipsychotic therapy.
METHODS


This 12-week randomized, double-blind, multicenter study compared the treatment efficacy on psychotic symptoms, cognitive functions, and tolerance between paliperidone ER (6-15 mg/d, n = 45) and olanzapine (10-30 mg/d, n = 41) in treatment-resistant or treatment-intolerant patients with schizophrenia. The severity of psychotic symptoms was evaluated by the Positive and Negative Syndrome Scale and the Clinical Global Impression Severity of Illness Scale. The cognitive functions were assessed by the MATRICS Consensus Cognitive Battery. In addition, the metabolic impacts were evaluated by weight gain and waist circumference.
RESULTS


Patients with either paliperidone ER or olanzapine treatment showed apparent improvement in psychotic symptoms, without significant intergroup difference. Twelve-week paliperidone ER or olanzapine treatment did not improve the cognitive functions. Both paliperidone ER and olanzapine treatment caused significant increase in weight and waist circumference, and olanzapine had a greater impact on waist circumference than paliperidone ER. In addition, both drugs were well tolerated.
CONCLUSIONS


Paliperidone ER could be a safe alternative for treatment-resistant schizophrenia.",2022,The severity of psychotic symptoms was evaluated by the Positive and Negative Syndrome Scale and the Clinical Global Impression Severity of Illness Scale.,"['Treatment-Resistant Schizophrenia', 'schizophrenia patients with either poor treatment response or intolerable adverse effects due to standardized antipsychotic therapy', 'patients with schizophrenia']","['Paliperidone ER', 'Olanzapine', 'paliperidone ER or olanzapine', 'paliperidone ER', 'treatment-resistant or treatment-intolerant', 'paliperidone', 'olanzapine', 'Paliperidone']","['psychotic symptoms', 'tolerated', 'weight and waist circumference', 'efficacy and safety', 'cognitive functions', 'weight gain and waist circumference', 'psychotic symptoms, cognitive functions, and tolerance', 'waist circumference', 'severity of psychotic symptoms', 'Positive and Negative Syndrome Scale and the Clinical Global Impression Severity of Illness Scale']","[{'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0753678', 'cui_str': 'paliperidone'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.0581574,The severity of psychotic symptoms was evaluated by the Positive and Negative Syndrome Scale and the Clinical Global Impression Severity of Illness Scale.,"[{'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Fangzhen', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': ""Department of Psychiatry, Yongkang Third People's Hospital, Jinhua.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Psychiatry, Third People's Hospital of Huzhou, Huzhou.""}, {'ForeName': 'Yucheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Ningbo Kangning Hospital, Ningbo.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Department of Psychiatry, Ningbo Kangning Hospital, Ningbo.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, the Second Hospital of Jinhua, Jinhua.'}, {'ForeName': 'Mingrong', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Department of Psychiatry, Jiaxing Kangci Hospital, Jiaxing.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': ""Department of Psychiatry, Affiliated Mental Health Center and Hangzhou Seventh People's Hospital, Zhejiang University School of Medicine.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Psychiatry, the First People's Hospital of Xiaoshan, Hangzhou.""}, {'ForeName': 'Wenzhen', 'Initials': 'W', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, the Seventh Hospital of Wenzhou.'}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'Department of Psychiatry, Affiliated Kangning Hospital of Wenzhou Medical University, Wenzhou.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Department of Psychiatry, Jiaxing Kangci Hospital, Jiaxing.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Jingkai', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Chanchan', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001573']
1663,35695692,Postoperative Analgesic and Anti-inflammatory Effectiveness of Ginger (Zingiber officinale) and NSAIDs as Adjuncts to Nonsurgical Periodontal Therapy for the Management of Periodontitis.,"PURPOSE


The authors hypothesize that ginger (Zingiber officinale) tablets and non-steroidal anti-inflammatory drugs (NSAIDs) are effective in reducing postoperative self-rated pain and periodontal parameters (plaque index [PI], gingival index [GI], and probing depth [PD], clinical attachment loss [AL] and marginal bone loss) following non-surgical periodontal therapy (NSPT) in patients with periodontitis. The aim was to compare the postoperative analgesic and anti-inflammatory effectiveness of ginger tablets and NSAIDs as adjuncts to nonsurgical periodontal therapy for the management of periodontitis. Materials and Methods: Patients with periodontitis were included. All patients underwent NSPT. In groups 1 and 2, patients received postoperative ginger (400 mg) and non-steroidal anti-inflammatory drugs (400 mg), respectively. Demographic data were collected, and full-mouth periodontal parameters (PI, GI, PD and CAL) were evaluated at baseline and at 7, 14 and 21 days. Self-rated pain scores were assessed at baseline, and at 24 h, 3 and 7 days of follow-up. In both groups, self-rated pain was assessed pre- and postoperatively using the numeric rating scale (NRS). Power analysis was performed on data from a pilot investigation and group comparisons were done. Statistical significance was set at p < 0.01.
RESULTS


Baseline mean NRS scores in groups 1 and 2 were 4.19 ± 0.12 and 4.13 ± 0.08, respectively. All participants had stage II/grade B periodontitis. At baseline, self-rated pain scores were significantly higher among patients in groups 1 and 2 at 24 h (p < 0.01) and 3 days (p < 0.01) of follow-up. In groups 1 (p < 0.01) and 2 (p < 0.01), self-rated pain scores were significantly higher at 24 h compared with 3 days of follow-up. In both groups, there was a significant reduction in PI (p < 0.01), GI (p < 0.01) and PD (p < 0.01) at 7, 14 and 21 days of follow-up compared with baseline.
CONCLUSION


Ginger and traditional NSAIDs are effective in reducing postoperative pain and inflammation following NSPT in patients with moderate periodontitis.",2022,"In both groups, there was a significant reduction in PI (p < 0.01), GI (p < 0.01) and PD (p < 0.01) at 7, 14 and 21 days of follow-up compared with baseline.
","['All participants had stage II/grade B periodontitis', 'Patients with periodontitis were included', 'patients with moderate periodontitis', 'patients with periodontitis']","['ginger tablets and NSAIDs', 'postoperative ginger (400 mg) and non-steroidal anti-inflammatory drugs', 'NSPT', 'surgical periodontal therapy (NSPT', 'Ginger (Zingiber officinale) and NSAIDs', 'ginger (Zingiber officinale) tablets and non-steroidal anti-inflammatory drugs (NSAIDs', 'Ginger and traditional NSAIDs']","['postoperative self-rated pain and periodontal parameters (plaque index [PI], gingival index [GI], and probing depth [PD], clinical attachment loss [AL] and marginal bone loss', 'Baseline mean NRS scores', 'self-rated pain', 'Self-rated pain scores', 'postoperative analgesic and anti-inflammatory effectiveness', 'numeric rating scale (NRS', 'postoperative pain and inflammation', 'PD', 'PI', 'self-rated pain scores', 'full-mouth periodontal parameters (PI, GI, PD and CAL']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0441806', 'cui_str': 'Grade B'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",,0.0186153,"In both groups, there was a significant reduction in PI (p < 0.01), GI (p < 0.01) and PD (p < 0.01) at 7, 14 and 21 days of follow-up compared with baseline.
","[{'ForeName': 'Nouf', 'Initials': 'N', 'LastName': 'Alshibani', 'Affiliation': ''}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Al-Kattan', 'Affiliation': ''}, {'ForeName': 'Lamees', 'Initials': 'L', 'LastName': 'Alssum', 'Affiliation': ''}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Basudan', 'Affiliation': ''}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Shaheen', 'Affiliation': ''}, {'ForeName': 'Montaser N', 'Initials': 'MN', 'LastName': 'Alqutub', 'Affiliation': ''}, {'ForeName': 'Fahda', 'Initials': 'F', 'LastName': 'Al Dahash', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.b3125633']
1664,35696051,Bioabsorbable Glycolide Copolymer is Effective in Reducing Staple Line Bleeding in Sleeve Gastrectomy.,"BACKGROUND


Postoperative bleeding from the staple line after sleeve gastrectomy occurs in 2-8% of patients and it is associated with increased length and cost of hospitalization and may demand reoperation to gain hemostasis. Reinforced staplers are used by bariatric surgeons to reduce the incidence of postoperative leak but can have a role in avoiding bleeding. The aim of this study is to analyze the effects of reinforcement on the whole gastric staple line during sleeve gastrectomy on postoperative bleeding.
METHODS


Four hundred forty-eight consecutive patients undergoing sleeve gastrectomy from November 2012 to April 2019 were divided into two groups. In the Top-only group only the top staple shot was realized with reinforced material (GORE® SEAMGUARD®) while in the Bottom-to-Top group, patients received full staple line reinforcement. Statistical analysis focused on postoperative leak and bleeding, and length of stay; a propensity score matching analysis was performed to reduce between-group characteristics imbalance.
RESULTS


One hundred forty-five (Top-only) and 303 (Bottom-to-Top) patients were included. Four (2.8%) patients in the Top-only group and none in the Bottom-to-Top group experienced severe bleeding (p = 0.004); the difference was still significant after propensity score matching. Length of stay was significantly shorter for the Bottom-to-Top group before and after propensity score matching (4 vs. 5 days, p < 0.001).
CONCLUSIONS


Staple line buttressing reduces the incidence of severe postoperative bleeding when performed on the whole staple line, and it is associated with a shorter hospitalization.",2022,"Length of stay was significantly shorter for the Bottom-to-Top group before and after propensity score matching (4 vs. 5 days, p < 0.001).
","['Four hundred forty-eight consecutive patients undergoing sleeve gastrectomy from November 2012 to April 2019', 'Sleeve Gastrectomy', 'One hundred forty-five (Top-only) and 303 (Bottom-to-Top) patients were included']","['full staple line reinforcement', 'Staple line buttressing', 'Bioabsorbable Glycolide Copolymer']","['severe bleeding', 'severe postoperative bleeding', 'length and cost of hospitalization', 'Length of stay', 'postoperative leak and bleeding, and length of stay']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C3833240', 'cui_str': 'GLYCOLIDE'}, {'cui': 'C0596383', 'cui_str': 'Copolymer'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",448.0,0.0348234,"Length of stay was significantly shorter for the Bottom-to-Top group before and after propensity score matching (4 vs. 5 days, p < 0.001).
","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Iannelli', 'Affiliation': ""Université Côte d'Azur, Nice, France. iannelli.a@chu-nice.fr.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chierici', 'Affiliation': ""Service de Chirurgie Digestive, Centre Hospitalier d'Antibes Juan-Les-Pins, 107, av. de Nice, 06600, Antibes, France.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Castaldi', 'Affiliation': 'Digestive Surgery and Liver Transplantation Unit, Centre Hospitalier Universitaire de Nice, Archet 2 Hospital, 151 Route Saint Antoine de Ginestière, BP 3079, Nice, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Drai', 'Affiliation': ""Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Schneck', 'Affiliation': 'Digestive Surgery Unit, Centre Hospitalier Universitaire de Guadeloupe, 97159, Pointe à Pitre, Guadeloupe.'}]",Obesity surgery,['10.1007/s11695-022-06152-3']
1665,35696045,Temporal Trends in Grade 3/4 Adverse Events and Associated Costs of Nivolumab Plus Cabozantinib Versus Sunitinib for Previously Untreated Advanced Renal Cell Carcinoma.,"BACKGROUND AND OBJECTIVES


Novel immunotherapy-based combination treatments have drastically improved clinical outcomes for previously untreated patients with advanced/metastatic renal cell carcinoma (aRCC). This study aimed to assess the temporal trends in grade 3/4 adverse event (AE) rates and associated costs of nivolumab plus cabozantinib combination therapy versus sunitinib monotherapy in previously untreated patients with aRCC.
METHODS


Individual patient data from the CheckMate 9ER trial (nivolumab plus cabozantinib: N = 320; sunitinib: N = 320) were used to calculate the proportion of patients experiencing grade 3/4 AEs. AE unit costs were obtained from the United States (US) 2017 Healthcare Cost and Utilization Project (HCUP) and inflated to 2020 US dollars. Per-patient-per-month (PPPM) all-cause and treatment-related grade 3/4 AE costs over 18-months, temporal trends, and top drivers of AE costs were evaluated in both treatment arms.
RESULTS


Overall, the proportion of patients experiencing grade 3/4 AEs decreased over time, with the highest rates observed in the first 3 months for the nivolumab plus cabozantinib and sunitinib arms. Compared with sunitinib, nivolumab plus cabozantinib was associated with consistently lower average all-cause AE costs PPPM [month 3: $2021 vs. $3097 (p < 0.05); month 6: $1653 vs. $2418 (p < 0.05); month 12: $1450 vs. $1935 (p > 0.05); month 18: $1337 vs. $1755 (p > 0.05)]. Over 18 months, metabolism and nutrition disorders ($244), laboratory abnormalities ($182), and general disorders and administration site conditions ($122) were the costliest all-cause PPPM AE categories in the nivolumab plus cabozantinib arm, and laboratory abnormalities ($443), blood and lymphatic system disorders ($254), and metabolism and nutrition disorders ($177) were the costliest in the sunitinib arm. Trends of treatment-related AE costs were consistent with all-cause AE costs.
CONCLUSIONS


Nivolumab plus cabozantinib was associated with lower costs of grade 3/4 AE management PPPM than sunitinib, which accumulated over the 18-month study period.",2022,"Overall, the proportion of patients experiencing grade 3/4 AEs decreased over time, with the highest rates observed in the first 3 months for the nivolumab plus cabozantinib and sunitinib arms.","['Individual patient data from the CheckMate 9ER trial ', 'previously untreated patients with advanced/metastatic renal cell carcinoma (aRCC', 'previously untreated patients with aRCC']","['nivolumab plus cabozantinib', 'Healthcare Cost and Utilization Project (HCUP', 'nivolumab plus cabozantinib combination therapy versus sunitinib monotherapy']","['laboratory abnormalities ($182), and general disorders and administration site conditions', 'metabolism and nutrition disorders', 'grade 3/4 adverse event (AE) rates and associated costs', 'AE unit costs', 'blood and lymphatic system disorders ($254), and metabolism and nutrition disorders']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0851362', 'cui_str': 'General disorders and administration site conditions'}, {'cui': 'C0851358', 'cui_str': 'Metabolism and nutrition disorders'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0851353', 'cui_str': 'Blood and Lymphatic System Disorders'}]",320.0,0.120414,"Overall, the proportion of patients experiencing grade 3/4 AEs decreased over time, with the highest rates observed in the first 3 months for the nivolumab plus cabozantinib and sunitinib arms.","[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Burotto', 'Affiliation': 'Oncology Department, Bradford Hill Clinical Research Center, Santiago, Chile.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': ""Interdisciplinary Department of Medicine, University of Bari 'A.Moro' and Division of Oncology, A.O.U. Consorziale Policlinico di Bari, Bari, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suarez', 'Affiliation': ""Medical Oncology, Vall d' Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d' Hebron, Vall d' Hebron Barcelona Hospital Campus, Barcelona, Spain.""}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Bourlon', 'Affiliation': 'Department of Hemato-Oncology, Urologic Oncology Clinic, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Huo', 'Affiliation': 'Worldwide Health Economics and Outcomes Research-US Market, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Del Tejo', 'Affiliation': 'US Medical Oncology, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Ella X', 'Initials': 'EX', 'LastName': 'Du', 'Affiliation': 'Health Economics and Outcomes Research, Analysis Group, Inc., Los Angeles, CA, USA.'}, {'ForeName': 'Xiaoran', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Health Economics and Outcomes Research, Analysis Group, Inc., Los Angeles, CA, USA.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Betts', 'Affiliation': 'Health Economics and Outcomes Research, Analysis Group, Inc., Los Angeles, CA, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Department of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'McGregor', 'Affiliation': 'Department of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA. bradley_mcgregor@dfci.harvard.edu.'}]",Clinical drug investigation,['10.1007/s40261-022-01170-6']
1666,35696023,"Effect of Reducing Pigmentation by Collagen Peptide Intake: A Randomized, Double-Blind, Placebo-Controlled Study.","INTRODUCTION


We examined the effect of 5.0 g/day of collagen peptide (CP) or collagen peptide fermented with Aspergillus sojae (FCP) on skin pigmentation in healthy participants.
METHODS


In this randomized, double-blind, placebo-controlled study, 44 men and women aged 25-63 years were placed into three groups by stratified random allocation and treated with CP, FCP, or placebo (PL) at 5.0 g/day for 3 months. Their skin condition was measured monthly from baseline to 3 months of intake.
RESULTS


No adverse events were identified in any group. The CP group showed a significant reduction in pigmented patches and redness after 1 and 3 months of intake, respectively. In the FCP group, pigmented macules were significantly reduced after 1 month, and pigmented patches after 2 months. Both the all-ages analysis and the hierarchical analysis below 55 years old yielded similar results.
CONCLUSION


Intake of 5.0 g/day of FCP for 3 months is safe. CP and FCP intake is useful for suppressing pigmentation. In addition, CP intake may be useful for reducing redness. These results suggest a new beneficial effect on the skin of CP supplementation.
TRIAL REGISTRATION


UMIN clinical trials registry system, UMIN000040736.",2022,"The CP group showed a significant reduction in pigmented patches and redness after 1 and 3 months of intake, respectively.","['44 men and women aged 25-63\xa0years', 'healthy participants']","['FCP', 'CP, FCP, or placebo (PL', 'collagen peptide (CP) or collagen peptide fermented with Aspergillus sojae (FCP', 'placebo', 'Placebo']","['adverse events', 'pigmented patches and redness']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1009246', 'cui_str': 'Aspergillus sojae'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",44.0,0.416613,"The CP group showed a significant reduction in pigmented patches and redness after 1 and 3 months of intake, respectively.","[{'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Himeno', 'Affiliation': 'Nitta Gelatin Inc., R&D Center, 2-22 Futamata, Yao-City, Osaka, Japan. a-himeno@nitta-gelatin.co.jp.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Tsujikami', 'Affiliation': 'Nitta Gelatin Inc., R&D Center, 2-22 Futamata, Yao-City, Osaka, Japan.'}, {'ForeName': 'Seiko', 'Initials': 'S', 'LastName': 'Koizumi', 'Affiliation': 'Nitta Gelatin Inc., R&D Center, 2-22 Futamata, Yao-City, Osaka, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': ""Sonoda Women's University, Hyogo, Japan.""}, {'ForeName': 'Michiya', 'Initials': 'M', 'LastName': 'Igase', 'Affiliation': 'Department of Anti-Aging Medicine, Ehime University Graduate School of Medicine, Ehime, Japan.'}]",Dermatology and therapy,['10.1007/s13555-022-00748-4']
1667,35695996,Efficacy and safety of neuromuscular electrical stimulation in the prevention of pressure injuries in critically ill patients: a randomized controlled trial.,"BACKGROUND


Pressure injuries (PIs), especially in the sacral region are frequent, costly, and increase morbidity and mortality of patients in an intensive care unit (ICU). These injuries can occur as a result of prolonged pressure and/or shear forces. Neuromuscular electrical stimulation (NMES) can increase muscle mass and improve local circulation, potentially reducing the incidence of PI.
METHODS


We performed a randomized controlled trial to assess the efficacy and safety of NMES in preventing PI in critically ill patients. We included patients with a period of less than 48 h in the ICU, aged ≥ 18 years. Participants were randomly selected (1:1 ratio) to receive NMES and usual care (NMES group) or only usual care (control group-CG) until discharge, death, or onset of a PI. To assess the effectiveness of NMES, we calculated the relative risk (RR) and number needed to treat (NNT). We assessed the muscle thickness of the gluteus maximus by ultrasonography. To assess safety, we analyzed the effects of NMES on vital signs and checked for the presence of skin burns in the stimulated areas. Clinical outcomes were assessed by time on mechanical ventilation, ICU mortality rate, and length of stay in the ICU.
RESULTS


We enrolled 149 participants, 76 in the NMES group. PIs were present in 26 (35.6%) patients in the CG and 4 (5.3%) in the NMES group (p ˂ 0.001). The NMES group had an RR = 0.15 (95% CI 0.05-0.40) to develop a PI, NNT = 3.3 (95% CI 2.3-5.9). Moreover, the NMES group presented a shorter length of stay in the ICU: Δ = - 1.8 ± 1.2 days, p = 0.04. There was no significant difference in gluteus maximus thickness between groups (CG: Δ = - 0.37 ± 1.2 cm vs. NMES group: Δ = 0 ± 0.98 cm, p = 0.33). NMES did not promote deleterious changes in vital signs and we did not detect skin burns.
CONCLUSIONS


NMES is an effective and safe therapy for the prevention of PI in critically ill patients and may reduce length of stay in the ICU. Trial registration RBR-8nt9m4. Registered prospectively on July 20th, 2018, https://ensaiosclinicos.gov.br/rg/RBR-8nt9m4.",2022,"There was no significant difference in gluteus maximus thickness between groups (CG: Δ = - 0.37 ± 1.2 cm vs. NMES group: Δ = 0 ± 0.98 cm, p = 0.33).","['patients in an intensive care unit (ICU', 'We enrolled 149 participants, 76 in the NMES group', 'critically ill patients', 'patients with a period of less than 48\xa0h in the ICU, aged\u2009≥\u200918\xa0years']","['neuromuscular electrical stimulation', 'Neuromuscular electrical stimulation (NMES', 'NMES and usual care (NMES group) or only usual care (control group-CG', 'NMES']","['relative risk (RR) and number needed to treat (NNT', 'shorter length of stay', 'efficacy and safety', 'Efficacy and safety', 'gluteus maximus thickness', 'time on mechanical ventilation, ICU mortality rate, and length of stay in the ICU']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",149.0,0.100869,"There was no significant difference in gluteus maximus thickness between groups (CG: Δ = - 0.37 ± 1.2 cm vs. NMES group: Δ = 0 ± 0.98 cm, p = 0.33).","[{'ForeName': 'Miriam Viviane', 'Initials': 'MV', 'LastName': 'Baron', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Rio Grande do Sul, Porto Alegre, Brazil. miriambaron9@gmail.com.'}, {'ForeName': 'Paulo Eugênio', 'Initials': 'PE', 'LastName': 'Silva', 'Affiliation': 'Secretaria de Estado de Saúde do Distrito Federal, Hospital de Base do Distrito Federal, Distrito Federal, Brasília, Brazil.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Koepp', 'Affiliation': 'University of Santa Cruz do Sul, Santa Cruz do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Janete de Souza', 'Initials': 'JS', 'LastName': 'Urbanetto', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Andres Felipe Mantilla', 'Initials': 'AFM', 'LastName': 'Santamaria', 'Affiliation': 'Industrial University of Santander, Bucaramanga, Santander, Colombia.'}, {'ForeName': 'Michele Paula', 'Initials': 'MP', 'LastName': 'Dos Santos', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Marcus Vinicius', 'Initials': 'MV', 'LastName': 'de Mello Pinto', 'Affiliation': 'Instituto Celulare, Itaipava, Rio de Janeiro, Brazil.'}, {'ForeName': 'Cristine', 'Initials': 'C', 'LastName': 'Brandenburg', 'Affiliation': 'Faculdade de Educação, Ciências e Letras do Sertão Central, Quixadá, Ceará, Brazil.'}, {'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Reinheimer', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Carvalho', 'Affiliation': 'Rigshospital, Inge Lehmannsvej, Copenhagen East, Denmark.'}, {'ForeName': 'Mário Bernardes', 'Initials': 'MB', 'LastName': 'Wagner', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Miliou', 'Affiliation': 'State University of Campinas, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Poli-de-Figueiredo', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bartira Ercília', 'Initials': 'BE', 'LastName': 'Pinheiro da Costa', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Rio Grande do Sul, Porto Alegre, Brazil.'}]",Annals of intensive care,['10.1186/s13613-022-01029-1']
1668,35695970,Inclusion of information technology-based assessments of health-related quality of life in routine oncology practice in Uruguay.,"BACKGROUND


Previous research has shown that the inclusion of patient-reported outcomes measures in the patient's visit to the oncologists might improve the quality of global health care. The aim of the study was to assess the feasibility, acceptance, and utility perceived by patients and oncologists of health-related quality of life (HRQL) assessments obtained prior to clinical visits, and to evaluate if this has an impact on patient's well-being in a sample of Spanish-speaking patients from Uruguay.
METHODS


Patients assisted regularly in the Oncology Clinic were randomized into two groups: an intervention group that completed a set of questionnaires (European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Hospital Anxiety and Depression Scale using a touch screen device and a control group that did not respond to these questionnaires. At 2 months, the responses of all the participants to the Functional Assessment of Cancer Therapy-General (FACT-G) were collected over a telephone to determine whether there were differences in the HRQL between the intervention and control groups. The graphed scores of the intervention group were included in the clinical history of the patient during consultation. Patients and physicians completed the questionnaires on the usefulness of these measurements.
RESULTS


In total, 58 patients participated in this study: 36 in the intervention group and 22 in the control group; 65% of the participants were female, and median age was 59 years (18-79). Regarding patients, 97% found the questionnaires easy to complete and thought that they included important questions. As for oncologists, 68.8% used the information and 87.5% found it useful for the consultation. There were no significant differences in the FACT-G scores between the intervention and control groups.
CONCLUSIONS


The routine HRQL assessments using an electronic device prior to the consultations were positively valued by almost all patients and physicians. This could significantly contribute to a better understanding of the patient's overall problems during consultation. These results confirm the benefits of integrating the patient's self-reported quality of life outcomes into consultations.",2022,"There were no significant differences in the FACT-G scores between the intervention and control groups.
","['58 patients participated in this study: 36 in the intervention group and 22 in the control group; 65% of the participants were female, and median age was 59\xa0years (18-79', 'Patients assisted regularly in the Oncology Clinic', 'routine oncology practice in Uruguay']",[],"['FACT-G scores', 'Cancer-Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Hospital Anxiety and Depression Scale', 'Functional Assessment of Cancer Therapy-General']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0042113', 'cui_str': 'Uruguay'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",58.0,0.0292903,"There were no significant differences in the FACT-G scores between the intervention and control groups.
","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Castillo', 'Affiliation': 'Department of Clínical Oncology, Facultad de Medicina - Universidad de La República, Hospital de Clínicas ""Dr. Manual Quintela"". Av. Italia 2870, Planta Baja, 11600, Montevideo, Uruguay.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Alfonso', 'Affiliation': 'Department of Clínical Oncology, Facultad de Medicina - Universidad de La República, Hospital de Clínicas ""Dr. Manual Quintela"". Av. Italia 2870, Planta Baja, 11600, Montevideo, Uruguay.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Dapueto', 'Affiliation': 'Department of Medical Psychology, Facultad de Medicina - Universidad de La República, Hospital de Clínicas ""Dr. Manual Quintela"". Av. Italia 2870, piso 15, 11600, Montevideo, Uruguay. jdapueto@hc.edu.uy.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Camejo', 'Affiliation': 'Department of Clínical Oncology, Facultad de Medicina - Universidad de La República, Hospital de Clínicas ""Dr. Manual Quintela"". Av. Italia 2870, Planta Baja, 11600, Montevideo, Uruguay.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Humana IT, Enrique Muñoz 887, 11300, Montevideo, Uruguay.'}]",Journal of patient-reported outcomes,['10.1186/s41687-022-00458-7']
1669,35695947,Group comprehensive behavioral intervention for tics contribution to broader cognitive and emotion regulation in children.,"There is increasing evidence for the effectiveness of behavioral techniques in managing tics in youth with Tourette syndrome and tics disorders (TDs). One such intervention is Comprehensive Behavioral Intervention for Tics (CBIT), which focuses on reducing tic severity by training control and regulation. In view of the regulation deficits characteristic to TDs, in the current study, we aimed to explore the contribution of CBIT beyond tic control, to a wider expression of regulation abilities-cognitive inhibition and emotion regulation. A total of 55 participants with TDs, aged 8-15, who were randomly assigned to group-CBIT or group-Educational Intervention for Tics, were compared on cognitive inhibition tests and use of emotion-regulation strategies, pre- and post-intervention. Whereas on none of the scales a significant interaction effect was found reflecting superiority of CBIT over EIT, repeated measures ANOVA revealed a significant time effect, with post hoc analyses indicating that cognitive inhibition and cognitive reappraisal significantly increased following CBIT intervention only. Within the group-CBIT, the increase in cognitive reappraisal was associated with higher intellectual ability. These findings may lead to a broader understanding of CBIT contribution to more than tic control, but rather to better cognitive and emotional regulation abilities.",2022,There is increasing evidence for the effectiveness of behavioral techniques in managing tics in youth with Tourette syndrome and tics disorders (TDs).,"['children', '55 participants with TDs, aged 8-15', 'youth with Tourette syndrome and tics disorders (TDs']","['CBIT or group-Educational Intervention for Tics, were compared on cognitive inhibition tests and use of emotion-regulation strategies, pre- and post-intervention', 'comprehensive behavioral intervention']","['cognitive inhibition and cognitive reappraisal', 'cognitive reappraisal']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0201783', 'cui_str': 'Inhibition test'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",55.0,0.0114377,There is increasing evidence for the effectiveness of behavioral techniques in managing tics in youth with Tourette syndrome and tics disorders (TDs).,"[{'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Gur', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Mount Scopus, 9190501, Jerusalem, Israel. noeigur@gmail.com.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Zimmerman-Brenner', 'Affiliation': 'The Tourette Syndrome Association in Israel (TSAI), Tel Aviv-Yafo, Israel.'}, {'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Fattal-Valevski', 'Affiliation': ""The Pediatric Neurology Unit, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rotstein', 'Affiliation': ""The Pediatric Neurology Unit, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Pilowsky Peleg', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Mount Scopus, 9190501, Jerusalem, Israel.'}]",European child & adolescent psychiatry,['10.1007/s00787-022-02018-2']
1670,35695945,Assessment of absorbable gelatin sponge for maxillary sinus floor elevation versus anorganic bovine bone minerals: a randomized clinical trial.,"PURPOSE


The present study compared the absorbable gelatin sponge as a space-filling material versus anorganic bone bovine mineral (ABBM) in maxillary sinus augmentation with simultaneous endosseous dental implant placement.
METHODS


Eighteen maxillary sinus floor elevation cases were randomly allocated into two groups. The first group received ABBM, while the second group received an absorbable gelatin sponge as a space-filling material. For both groups, CBCT scans were obtained immediately postoperatively and six months later to calculate the difference in sinus floor bone gain. Osstell readings were recorded both at the time of implant placement and implant exposure with a total of twenty-three dental implant placements in relation to the eighteen elevated sinus floors.
RESULTS


The mean radiographic sinus floor gain in the ABBM group was 10.2 mm (± 2.5), while in the absorbable gelatin sponge group was 5.4 mm (± 2.0), with a mean difference of 4.8, which was statistically significant (p < 0.001). The mean implant stability for the ABBM was 77.3 (± 4.9), while in the absorbable gelatin sponge group was 74.2 (± 3.0), with a mean difference of 3.1, which was statistically insignificant (p = 0.1610).
CONCLUSION


The ABBM showed superior results regarding the amount of radiographic sinus floor bone gain. However, the implant stability was invariable between both groups.",2022,"The mean radiographic sinus floor gain in the ABBM group was 10.2 mm (± 2.5), while in the absorbable gelatin sponge group was 5.4 mm (± 2.0), with a mean difference of 4.8, which was statistically significant (","['maxillary sinus augmentation with simultaneous endosseous dental implant placement', 'maxillary sinus floor elevation versus anorganic bovine bone minerals', 'Eighteen maxillary sinus floor elevation cases']","['absorbable gelatin sponge as a space-filling material versus anorganic bone bovine mineral (ABBM', 'ABBM', 'absorbable gelatin sponge']","['implant stability', 'mean radiographic sinus floor gain', 'mean implant stability', 'sinus floor bone gain', 'radiographic sinus floor bone gain', 'Osstell readings']","[{'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0011371', 'cui_str': 'Endosseous Dental Implantation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0017238', 'cui_str': 'absorbable gelatin sponge'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",23.0,0.0592293,"The mean radiographic sinus floor gain in the ABBM group was 10.2 mm (± 2.5), while in the absorbable gelatin sponge group was 5.4 mm (± 2.0), with a mean difference of 4.8, which was statistically significant (","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Kandel', 'Affiliation': 'Department of Oral Implantology, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Shawky', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Egyptian Russian University, Badr City, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Gibaly', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Beni-Suef University, Beni-Suef, Egypt. amrgibaly@dent.bsu.edu.eg.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mounir', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Niveen', 'Initials': 'N', 'LastName': 'Askar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Atef', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",Oral and maxillofacial surgery,['10.1007/s10006-022-01086-7']
1671,35696263,Does the Effect of a 3-Year Lifestyle Intervention on Body Weight and Cardiometabolic Health Differ by Prediabetes Metabolic Phenotype? A Post Hoc Analysis of the PREVIEW Study.,"OBJECTIVE


To examine whether the effect of a 3-year lifestyle intervention on body weight and cardiometabolic risk factors differs by prediabetes metabolic phenotype.
RESEARCH DESIGN AND METHODS


This post hoc analysis of the multicenter, randomized trial, PREVention of diabetes through lifestyle interventions and population studies In Europe and around the World (PREVIEW), included 1,510 participants with prediabetes (BMI ≥25 kg ⋅ m-2; defined using oral glucose tolerance tests). Of these, 58% had isolated impaired fasting glucose (iIFG), 6% had isolated impaired glucose tolerance (iIGT), and 36% had IFG+IGT; 73% had normal hemoglobin A1c (HbA1c; <39 mmol ⋅ mol-1) and 25% had intermediate HbA1c (39-47 mmol ⋅ mol-1). Participants underwent an 8-week diet-induced rapid weight loss, followed by a 148-week lifestyle-based weight maintenance intervention. Linear mixed models adjusted for intervention arm and other confounders were used.
RESULTS


In the available-case and complete-case analyses, participants with IFG+IGT had greater sustained weight loss after lifestyle intervention (adjusted mean at 156 weeks -3.5% [95% CI, -4.7%, -2.3%]) than those with iIFG (mean -2.5% [-3.6%, -1.3%]) relative to baseline (P = 0.011). Participants with IFG+IGT and iIFG had similar cardiometabolic benefits from the lifestyle intervention. The differences in cardiometabolic benefits between those with iIGT and IFG+IGT were minor or inconsistent in different analyses. Participants with normal versus intermediate HbA1c had similar weight loss over 3 years and minor differences in cardiometabolic benefits during weight loss, whereas those with normal HbA1c had greater improvements in fasting glucose, 2-h glucose (adjusted between-group difference at 156 weeks -0.54 mmol ⋅ L-1 [95% CI -0.70, -0.39], P < 0.001), and triglycerides (difference -0.07 mmol ⋅ L-1 [-0.11, -0.03], P < 0.001) during the lifestyle intervention.
CONCLUSIONS


Individuals with iIFG and IFG+IGT had similar improvements in cardiometabolic health from a lifestyle intervention. Those with normal HbA1c had greater improvements than those with intermediate HbA1c.",2022,"Participants with normal versus intermediate HbA1c had similar weight loss over 3 years and minor differences in cardiometabolic benefits during weight loss, whereas those with normal HbA1c had greater improvements in fasting glucose, 2-h glucose (adjusted between-group difference at 156 weeks -0.54 mmol","['Participants with', 'Individuals with iIFG and', 'diabetes through lifestyle interventions and population studies In Europe and around the World (PREVIEW), included 1,510 participants with prediabetes (BMI ≥25 kg ⋅ m-2; defined using oral glucose tolerance tests']","['IFG+IGT and iIFG', 'Lifestyle Intervention', 'IFG+IGT', '⋅ L-1', '8-week diet-induced rapid weight loss, followed by a 148-week lifestyle-based weight maintenance intervention', '3-year lifestyle intervention']","['triglycerides', 'weight loss', 'Body Weight and Cardiometabolic Health', 'body weight and cardiometabolic risk factors', 'fasting glucose, 2-h glucose', 'cardiometabolic health', 'cardiometabolic benefits', 'normal hemoglobin A1c (HbA1c', 'glucose tolerance (iIGT', 'sustained weight loss', 'cardiometabolic benefits during weight loss', 'fasting glucose (iIFG']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600472', 'cui_str': 'L1 Elements'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0474529', 'cui_str': 'Hemoglobin normal'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",1510.0,0.0382595,"Participants with normal versus intermediate HbA1c had similar weight loss over 3 years and minor differences in cardiometabolic benefits during weight loss, whereas those with normal HbA1c had greater improvements in fasting glucose, 2-h glucose (adjusted between-group difference at 156 weeks -0.54 mmol","[{'ForeName': 'Ruixin', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Jalo', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Marta P', 'Initials': 'MP', 'LastName': 'Silvestre', 'Affiliation': 'Human Nutrition Unit, Department of Medicine, School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'Human Nutrition Unit, Department of Medicine, School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Handjieva-Darlenska', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Svetoslav', 'Initials': 'S', 'LastName': 'Handjiev', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Huttunen-Lenz', 'Affiliation': 'Institute for Nursing Science, University of Education Schwäbisch Gmünd, Schwäbisch Gmünd, Germany.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mackintosh', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea University, Swansea, U.K.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Stratton', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea University, Swansea, U.K.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Navas-Carretero', 'Affiliation': 'Centre for Nutrition Research, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Kirsi H', 'Initials': 'KH', 'LastName': 'Pietiläinen', 'Affiliation': 'Obesity Research Unit, Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Simpson', 'Affiliation': ""Division of Physiology, Pharmacology and Neuroscience, School of Life Sciences, Queen's Medical Centre, Medical Research Council (MRC)/Alzheimer's Research UK (ARUK) Centre for Musculoskeletal Ageing Research, ARUK Centre for Sport, Exercise and Osteoarthritis, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham, U.K.""}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': ""Division of Physiology, Pharmacology and Neuroscience, School of Life Sciences, Queen's Medical Centre, Medical Research Council (MRC)/Alzheimer's Research UK (ARUK) Centre for Musculoskeletal Ageing Research, ARUK Centre for Sport, Exercise and Osteoarthritis, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham, U.K.""}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Brand-Miller', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Clinical Research, Copenhagen University Hospital-Steno Diabetes Center Copenhagen, Herlev, Denmark.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'Centro de Investigacion Biomedica en Red Area de Fisiologia de la Obesidad y la Nutricion (CIBEROBN), Madrid, Spain.'}, {'ForeName': 'Margriet S', 'Initials': 'MS', 'LastName': 'Westerterp-Plantenga', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Tanja C', 'Initials': 'TC', 'LastName': 'Adam', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}]",Diabetes care,['10.2337/dc22-0549']
1672,35696234,Quality of Life of Edentulous Patients with Single Mandibular Implants and Mandibular Overdentures Using Two Different Attachments: A Randomized Clinical Trial.,"PURPOSE


To compare the changes in quality of life in edentulous patients with single implants supporting mandibular overdentures with two different attachment types before implant placement and after 6 and 24 months.
MATERIALS AND METHODS


Eighty edentulous patients were recruited, and all patients completed the validated Oral Health Impact Profile (OHIP)-EDENT-19 questionnaire before implant surgery. A single implant was placed in the midline of the edentulous mandibles. All implants were allowed to heal for 3 months. After the healing period, randomization into one of two groups was accomplished using sealed envelopes: group A (ball attachment) and group B (locator attachment). The same questionnaire was completed 6 and 24 months postplacement. Mann-Whitney U test for independent samples was used to compare the two groups, while Freidman test was used for comparison within each group. Two-sided P values less than .05 were considered statistically significant.
RESULTS


There was an improvement in all domains of the OHIP-EDENT-19 scores at the 6- and 24-month follow-ups for both groups. The social disability domain showed a statistically significant improvement for group A at 6 and 24 months postplacement (P = .004, .005). Within group A, there was a statistically significant improvement within all seven domains (P = .001); while in group B, four domains (functional limitation, physical pain, psychosocial discomfort, and physical disability) and the total score (P = .001) showed a statistically significant improvement.
CONCLUSION


Both attachments improved the patients' quality of life at 24 months postplacement. The ball attachment demonstrated a significant improvement regarding the social effects of the prostheses.",2022,"Within group A, there was a statistically significant improvement within all seven domains (P = .001);","['Edentulous Patients with Single Mandibular Implants and Mandibular Overdentures Using Two Different Attachments', 'edentulous patients with single implants supporting mandibular overdentures with two different attachment types before implant placement and after 6 and 24 months', 'Eighty edentulous patients']",[],"['four domains (functional limitation, physical pain, psychosocial discomfort, and physical disability) and the total score', 'Quality of Life', 'quality of life', 'validated Oral Health Impact Profile', ""patients' quality of life"", 'social disability domain', 'social effects']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816958', 'cui_str': '80'}]",[],"[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",80.0,0.0100016,"Within group A, there was a statistically significant improvement within all seven domains (P = .001);","[{'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Naguib', 'Affiliation': ''}, {'ForeName': 'Nagla', 'Initials': 'N', 'LastName': 'Nassouhy', 'Affiliation': ''}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'El Khourazaty', 'Affiliation': ''}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Salah', 'Affiliation': ''}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fouda', 'Affiliation': ''}, {'ForeName': 'Nouran A', 'Initials': 'NA', 'LastName': 'Nabi', 'Affiliation': ''}]",The International journal of prosthodontics,['10.11607/ijp.7942']
1673,35696185,Safety and Efficacy of Semorinemab in Individuals With Prodromal to Mild Alzheimer Disease: A Randomized Clinical Trial.,"Importance


Neurofibrillary tangles composed of aggregated tau protein are one of the neuropathological hallmarks of Alzheimer disease (AD) and correlate with clinical disease severity. Monoclonal antibodies targeting tau may have the potential to ameliorate AD progression by slowing or stopping the spread and/or accumulation of pathological tau.
Objective


To evaluate the safety and efficacy of the monoclonal anti-tau antibody semorinemab in prodromal to mild AD.
Design, Setting, and Participants


This phase 2 randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted between October 18, 2017, and July 16, 2020, at 97 sites in North America, Europe, and Australia. Individuals aged 50 to 80 years (inclusive) with prodromal to mild AD, Mini-Mental State Examination scores between 20 and 30 (inclusive), and confirmed β-amyloid pathology (by positron emission tomography or cerebrospinal fluid) were included.
Interventions


During the 73-week blinded study period, participants received intravenous infusions of placebo or semorinemab (1500 mg, 4500 mg, or 8100 mg) every 2 weeks for the first 3 infusions and every 4 weeks thereafter.
Main Outcomes and Measures


The primary outcomes were change from baseline on the Clinical Dementia Rating-Sum of Boxes score from baseline to week 73 and assessments of the safety and tolerability for semorinemab compared with placebo.
Results


In the modified intent-to-treat cohort (n = 422; mean [SD] age, 69.6 [7.0] years; 235 women [55.7%]), similar increases were seen on the Clinical Dementia Rating-Sum of Boxes score in the placebo (n = 126; Δ = 2.19 [95% CI, 1.74-2.63]) and semorinemab (1500 mg: n = 86; Δ = 2.36 [95% CI, 1.83-2.89]; 4500 mg: n = 126; Δ = 2.36 [95% CI, 1.92-2.79]; 8100 mg: n = 84; Δ = 2.41 [95% CI, 1.88-2.94]) arms. In the safety-evaluable cohort (n = 441), similar proportions of participants experienced adverse events in the placebo (130 [93.1%]) and semorinemab (1500 mg: 89 [88.8%]; 4500 mg: 132 [94.7%]; 8100 mg: 90 [92.2%]) arms.
Conclusions and Relevance


In participants with prodromal to mild AD in this randomized clinical trial, semorinemab did not slow clinical AD progression compared with placebo throughout the 73-week study period but did demonstrate an acceptable and well-tolerated safety profile. Additional studies of anti-tau antibodies may be needed to determine the clinical utility of this therapeutic approach.
Trial Registration


ClinicalTrials.gov Identifier: NCT03289143.",2022,"Monoclonal antibodies targeting tau may have the potential to ameliorate AD progression by slowing or stopping the spread and/or accumulation of pathological tau.
","['Individuals aged 50 to 80 years (inclusive) with prodromal to mild AD, Mini-Mental State Examination scores between 20 and 30 (inclusive), and confirmed β-amyloid pathology (by positron emission tomography or cerebrospinal fluid) were included', 'Individuals With Prodromal to Mild Alzheimer Disease', 'prodromal to mild AD', 'October 18, 2017, and July 16, 2020, at 97 sites in North America, Europe, and Australia']","['monoclonal anti-tau antibody semorinemab', 'Semorinemab', 'semorinemab', 'placebo or semorinemab', 'placebo']","['adverse events', 'acceptable and well-tolerated safety profile', 'Clinical Dementia Rating-Sum of Boxes score', 'safety and tolerability', 'Safety and Efficacy', 'safety and efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.936818,"Monoclonal antibodies targeting tau may have the potential to ameliorate AD progression by slowing or stopping the spread and/or accumulation of pathological tau.
","[{'ForeName': 'Edmond', 'Initials': 'E', 'LastName': 'Teng', 'Affiliation': 'Early Clinical Development, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Manser', 'Affiliation': 'Biostatistics, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Pickthorn', 'Affiliation': 'Early Clinical Development, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Brunstein', 'Affiliation': 'Product Development Safety, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Blendstrup', 'Affiliation': 'Clinical Operations, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sanabria Bohorquez', 'Affiliation': 'Clinical Imaging Group, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Wildsmith', 'Affiliation': 'Biomarker Development, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Bali', 'Initials': 'B', 'LastName': 'Toth', 'Affiliation': 'Biostatistics, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dolton', 'Affiliation': 'Roche Products Pty Limited, Sydney, Australia.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Ramakrishnan', 'Affiliation': 'Clinical Pharmacology, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Bobbala', 'Affiliation': 'Product Development Safety, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Sietske A M', 'Initials': 'SAM', 'LastName': 'Sikkes', 'Affiliation': 'Alzheimer Center Amsterdam, Amsterdam Neuroscience, Amsterdam University Medical Center, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ward', 'Affiliation': 'Early Clinical Development, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Reina N', 'Initials': 'RN', 'LastName': 'Fuji', 'Affiliation': 'Safety Assessment, Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Kerchner', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2022.1375']
1674,35696168,Home-Based Health Coaching for Girls With Overweight and Obesity: A Randomized Clinical Trial.,,2022,,"['With Overweight and Obesity', 'Girls']",['Home-Based Health Coaching'],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],,0.303605,,"[{'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Food, Nutrition, Dietetics and Health, Kansas State University, Manhattan.'}, {'ForeName': 'Brooke J', 'Initials': 'BJ', 'LastName': 'Cull', 'Affiliation': 'Department of Food, Nutrition, Dietetics and Health, Kansas State University, Manhattan.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Food, Nutrition, Dietetics and Health, Kansas State University, Manhattan.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Dzewaltowski', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.16720']
1675,35696165,Effect of Text Messaging and Behavioral Interventions on COVID-19 Vaccination Uptake: A Randomized Clinical Trial.,"Importance


COVID-19 vaccine uptake among urban populations remains low.
Objective


To evaluate whether text messaging with outbound or inbound scheduling and behaviorally informed content might increase COVID-19 vaccine uptake.
Design, Setting, and Participants


This randomized clinical trial with a factorial design was conducted from April 29 to July 6, 2021, in an urban academic health system. The trial comprised 16 045 patients at least 18 years of age in Philadelphia, Pennsylvania, with at least 1 primary care visit in the past 5 years, or a future scheduled primary care visit within the next 3 months, who were unresponsive to prior outreach. The study was prespecified in the trial protocol, and data were obtained from the intent-to-treat population.
Interventions


Eligible patients were randomly assigned in a 1:20:20 ratio to (1) outbound telephone call only by call center, (2) text message and outbound telephone call by call center to those who respond, or (3) text message, with patients instructed to make an inbound telephone call to a hotline. Patients in groups 2 and 3 were concurrently randomly assigned in a 1:1:1:1 ratio to receive different content: standard messaging, clinician endorsement (eg, ""Dr. XXX recommends""), scarcity (""limited supply available""), or endowment framing (""We have reserved a COVID-19 vaccine appointment for you"").
Main Outcomes and Measures


The primary outcome was the proportion of patients who completed the first dose of the COVID-19 vaccine within 1 month, according to the electronic health record. Secondary outcomes were the completion of the first dose within 2 months and completion of the vaccination series within 2 months of initial outreach. Additional outcomes included the percentage of patients with invalid cell phone numbers (wrong number or nontextable), no response to text messaging, the percentage of patients scheduled for the vaccine, text message responses, and the number of telephone calls made by the access center. Analysis was on an intention-to-treat basis.
Results


Among the 16 045 patients included, the mean (SD) age was 36.9 (11.1) years; 9418 (58.7%) were women; 12 869 (80.2%) had commercial insurance, and 2283 (14.2%) were insured by Medicaid; 8345 (52.0%) were White, 4706 (29.3%) were Black, and 967 (6.0%) were Hispanic or Latino. At 1 month, 14 of 390 patients (3.6% [95% CI, 1.7%-5.4%]) in the outbound telephone call-only group completed 1 vaccine dose, as did 243 of 7890 patients (3.1% [95% CI, 2.7%-3.5%]) in the text plus outbound call group (absolute difference, -0.5% [95% CI, -2.4% to 1.4%]; P = .57) and 253 of 7765 patients (3.3% [95% CI, 2.9%-3.7%]) in the text plus inbound call group (absolute difference, -0.3% [95% CI, -2.2% to 1.6%]; P = .72). Among the 15 655 patients receiving text messaging, 118 of 3889 patients (3.0% [95% CI, 2.5%-3.6%]) in the standard messaging group completed 1 vaccine dose, as did 135 of 3920 patients (3.4% [95% CI, 2.9%-4.0%]) in the clinician endorsement group (absolute difference, 0.4% [95% CI, -0.4% to 1.2%]; P = .31), 100 of 3911 patients (2.6% [95% CI, 2.1%-3.1%]) in the scarcity group (absolute difference, -0.5% [95% CI, -1.2% to 0.3%]; P = .20), and 143 of 3935 patients (3.6% [95% CI, 3.0%-4.2%]) in the endowment group (absolute difference, 0.6% [95% CI, -0.2% to 1.4%]; P = .14).
Conclusions and Relevance


There was no detectable increase in vaccination uptake among patients receiving text messaging compared with telephone calls only or behaviorally informed message content.
Trial Registration


ClinicalTrials.gov Identifier: NCT04834726.",2022,"There was no detectable increase in vaccination uptake among patients receiving text messaging compared with telephone calls only or behaviorally informed message content.
","['urban populations remains low', 'Among the 16\u202f045 patients included, the mean (SD) age was 36.9 (11.1) years; 9418 (58.7%) were women; 12\u202f869 (80.2%) had commercial insurance, and 2283 (14.2%) were insured by Medicaid; 8345 (52.0%) were White, 4706 (29.3%) were Black, and 967 (6.0%) were Hispanic or Latino', '16\u202f045 patients at least 18 years of age in Philadelphia, Pennsylvania, with at least 1 primary care visit in the past 5 years, or a future scheduled primary care visit within the next 3 months, who were unresponsive to prior outreach', 'April 29 to July 6, 2021, in an urban academic health system']","['Text Messaging and Behavioral Interventions', 'outbound telephone call only by call center, (2) text message and outbound telephone call by call center to those who respond, or (3) text message, with patients instructed to make an inbound telephone call to a hotline', 'content: standard messaging, clinician endorsement (eg, ""Dr. XXX recommends""), scarcity (""limited supply available""), or endowment framing (""We have reserved a COVID-19 vaccine appointment for you']","['COVID-19 Vaccination Uptake', 'vaccination uptake', 'completion of the first dose within 2 months and completion of the vaccination series within 2 months of initial outreach', 'percentage of patients with invalid cell phone numbers (wrong number or nontextable), no response to text messaging, the percentage of patients scheduled for the vaccine, text message responses, and the number of telephone calls made by the access center']","[{'cui': 'C0041935', 'cui_str': 'Urban Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4277665', 'cui_str': 'Call Center'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020042', 'cui_str': 'Telephone Hotlines'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0014265', 'cui_str': 'Endowments'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231173', 'cui_str': 'Invalidism'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",16045.0,0.619156,"There was no detectable increase in vaccination uptake among patients receiving text messaging compared with telephone calls only or behaviorally informed message content.
","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Mallozzi', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Shaw', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Vandertuyn', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Balachandran', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kopinsky', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christianne', 'Initials': 'C', 'LastName': 'Sevinc', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ward', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sae-Hwan', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Snider', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Rosin', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.16649']
1676,35584040,"The acute effect of a laboratory shame induction protocol on endothelial function in young, healthy adults.","NEW FINDINGS


What is the central question of this study? Shame is a form of social stress that involves internalizing social devaluations imposed by others. The aim of this study was to determine, for the first time, how acutely experienced shame impacts endothelial function. What is the main finding and its importance? Brachial artery flow-mediated dilatation, an index of endothelial function, was impaired after an intervention that acutely increased self-reported shame. This occurred without increases in cortisol or tumor necrosis factor alpha receptor binding. Frequent or prolonged shame-induced endothelial dysfunction could have important cardiovascular consequences.
ABSTRACT


The objective of this study was to examine the impact of a shame induction protocol on endothelial function. Fifteen participants (n = 7 men, n = 8 women) completed both a written shame induction protocol and a control protocol on two different experimental days. Pre- and post-protocol we assessed: (1) endothelial function and arterial shear rate via a standard brachial artery reactive hyperaemia flow-mediated dilatation (FMD) test across two post-intervention time points (15 and 35 min post); (2) perceived shame via the experiential shame scale (ESS); and (3) cortisol and soluble tumor necrosis factor alpha receptor (sTNFαRII) through oral fluid analysis. Shame increased after the shame induction protocol (pre, 2.9 ± 0.6 vs. post, 3.7 ± 0.5, P < 0.001) but not the control protocol (pre, 3.0 ± 0.5 vs. post, 2.8 ± 0.5, P = 0.15; protocol by time interaction, P < 0.001). When all three time points were included in the analysis, %FMD did not change over time. Considering only the lowest post time point, %FMD decreased significantly in response to the shame protocol (pre, 4.8 ± 1.9 vs. post, 3.2 ± 1.6, P < 0.001) but not the control protocol (pre, 4.2 ± 1.8 vs. post, 3.8 ± 1.5, P = 0.45; protocol by time interaction, P = 0.035). Covariation of the shear rate stimulus for FMD did not alter the FMD results. When including both the control and shame protocols, but not the shame protocol alone, increased shame was significantly associated with decreased FMD (r = -0.37, P < 0.046). There were no significant time by protocol interaction effects for cortisol or sTNFαRII. In conclusion, temporary increases in shame might cause transient endothelial dysfunction which, if chronically repeated, could manifest as reduced vasoprotection against atherosclerosis.",2022,"Brachial artery flow-mediated dilatation, an index of endothelial function, was impaired after an intervention that acutely increased self-reported shame.","['young, healthy adults', 'Fifteen participants (n\xa0=\xa07 men, n\xa0=\xa08 women']","['laboratory shame induction protocol', 'Pre- and post-protocol']","['endothelial function', 'FMD ', 'Shame', 'endothelial function and arterial shear rate via a standard brachial artery reactive hyperaemia flow-mediated dilatation (FMD) test', 'cortisol or tumor necrosis factor alpha receptor binding', '2) perceived shame via the experiential shame scale (ESS); and (3) cortisol and soluble tumor necrosis factor alpha receptor (sTNFαRII) through oral fluid analysis', 'Brachial artery flow-mediated dilatation, an index of endothelial function']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",15.0,0.0462555,"Brachial artery flow-mediated dilatation, an index of endothelial function, was impaired after an intervention that acutely increased self-reported shame.","[{'ForeName': 'Ellen C', 'Initials': 'EC', 'LastName': 'McGarity-Shipley', 'Affiliation': ""Cardiovascular Stress Response Laboratory, School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Lindsay A', 'Initials': 'LA', 'LastName': 'Lew', 'Affiliation': ""Cardiovascular Stress Response Laboratory, School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Bonafiglia', 'Affiliation': ""Muscle Physiology Laboratory, School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Kyra E', 'Initials': 'KE', 'LastName': 'Pyke', 'Affiliation': ""Cardiovascular Stress Response Laboratory, School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}]",Experimental physiology,['10.1113/EP090396']
1677,35677463,Observation on the Effect of MRI Image Scanning on Knee Pain in Football Injury.,"To study the effect of football injury on knee pain based on MRI image scanning, in this paper, a total of 31 knee injuries of 29 male professional football players from December 2012 to April 2015 were used as the experimental group. The players were 23.6 ± 3.5 years old and received professional football training time 15.3 ± 3.6 years; 31 outpatients of the same age group with acute knee joint acute injury were randomly selected as the control group; both groups were imaged with a 1.5 TMR scanner and knee joint standard array coil imaging, and 2 senior radiation surgeons evaluate knee cartilage, meniscus, ligaments, tendons, bone marrow, infrapatellar fat pad, and joint effusions. Pearson's chi-squared test and nonparametric test for two independent samples were used for statistical testing of the evaluation results. The experimental results showed that there were significant differences in the incidence of articular cartilage, lateral collateral ligament, tendon or ligament injury, multiligament or tendon injury, and bone marrow edema between the two groups ( P  < 0.05). There was no significant difference in the incidence of medial collateral ligament injury, infrapatellar fat pad edema, and joint effusion. MRI shows that knee injuries in male professional football players often involve ligaments or tendons, mostly multiligament or tendon injuries. The lesions of articular cartilage and meniscus are more common and serious, and bone marrow edema is also more common in football injuries. MRI has high diagnostic accuracy for various clinical knee injuries, and it belongs to a noninvasive examination method. It can not only reflect the pathological changes and changes of the knee joints of patients but also provide information for the formulation of clinical programs and the judgment of prognosis, for timely, accurate, and comprehensive imaging reference.",2022,"There was no significant difference in the incidence of medial collateral ligament injury, infrapatellar fat pad edema, and joint effusion.","['31 knee injuries of 29 male professional football players from December 2012 to April 2015 were used as the experimental group', 'Knee Pain in Football Injury', 'male professional football players', 'players were 23.6 ± 3.5 years old and received professional football training time 15.3 ± 3.6 years; 31 outpatients of the same age group with acute knee joint acute injury']","['MRI Image Scanning', 'MRI', 'TMR scanner and knee joint standard array coil imaging, and 2 senior radiation surgeons evaluate knee cartilage, meniscus, ligaments, tendons, bone marrow, infrapatellar fat pad, and joint effusions']","['incidence of articular cartilage, lateral collateral ligament, tendon or ligament injury, multiligament or tendon injury, and bone marrow edema', 'incidence of medial collateral ligament injury, infrapatellar fat pad edema, and joint effusion']","[{'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0224498', 'cui_str': 'Meniscus structure of joint'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C1253936', 'cui_str': 'Effusion of joint'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007303', 'cui_str': 'Structure of articular cartilage'}, {'cui': 'C3658298', 'cui_str': 'Lateral Collateral Ligament'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0435001', 'cui_str': 'Ligament injury'}, {'cui': 'C0039504', 'cui_str': 'Tendon injury'}, {'cui': 'C0948162', 'cui_str': 'Edema of bone marrow'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0206365', 'cui_str': 'Structure of collateral ligament'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C1253936', 'cui_str': 'Effusion of joint'}]",29.0,0.0224892,"There was no significant difference in the incidence of medial collateral ligament injury, infrapatellar fat pad edema, and joint effusion.","[{'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'College of Physical Education, Fuyang Normal University, Fuyang, Anhui 236037, China.'}]",Scanning,['10.1155/2022/7348978']
1678,35470143,Association Between EEG Patterns and Serum Neurofilament Light After Cardiac Arrest: A Post Hoc Analysis of the TTM Trial.,"BACKGROUND AND OBJECTIVES


EEG is widely used for prediction of neurologic outcome after cardiac arrest. To better understand the relationship between EEG and neuronal injury, we explored the association between EEG and neurofilament light (NfL) as a marker of neuroaxonal injury, evaluated whether highly malignant EEG patterns are reflected by high NfL levels, and explored the association of EEG backgrounds and EEG discharges with NfL.
METHODS


We performed a post hoc analysis of the Target Temperature Management After Out-of-Hospital Cardiac Arrest trial. Routine EEGs were prospectively performed after the temperature intervention ≥36 hours postarrest. Patients who awoke or died prior to 36 hours postarrest were excluded. EEG experts blinded to clinical information classified EEG background, amount of discharges, and highly malignant EEG patterns according to the standardized American Clinical Neurophysiology Society terminology. Prospectively collected serum samples were analyzed for NfL after trial completion. The highest available concentration at 48 or 72 hours postarrest was used.
RESULTS


A total of 262/939 patients with EEG and NfL data were included. Patients with highly malignant EEG patterns had 2.9 times higher NfL levels than patients with malignant patterns and NfL levels were 13 times higher in patients with malignant patterns than those with benign patterns (95% CI 1.4-6.1 and 6.5-26.2, respectively; effect size 0.47;  p  < 0.001). Both background and the amount of discharges were independently strongly associated with NfL levels ( p  < 0.001). The EEG background had a stronger association with NfL levels than EEG discharges (R 2  = 0.30 and R 2  = 0.10, respectively). NfL levels in patients with a continuous background were lower than for any other background (95% CI for discontinuous, burst-suppression, and suppression, respectively: 2.26-18.06, 3.91-41.71, and 5.74-41.74; effect size 0.30;  p  < 0.001 for all). NfL levels did not differ between suppression and burst suppression. Superimposed discharges were only associated with higher NfL levels if the EEG background was continuous.
DISCUSSION


Benign, malignant, and highly malignant EEG patterns reflect the extent of brain injury as measured by NfL in serum. The extent of brain injury is more strongly related to the EEG background than superimposed discharges. Combining EEG and NfL may be useful to better identify patients misclassified by single methods.
TRIAL REGISTRATION INFORMATION


ClinicalTrials.gov NCT01020916.",2022,"Patients with highly malignant EEG patterns had 2.9 times higher NfL levels than patients with malignant patterns and NfL levels were 13 times higher in patients with malignant patterns than those with benign patterns (95% CI 1.4-6.1 and 6.5-26.2, respectively; effect size 0.47;  p  < 0.001).","['262/939 patients with EEG and NfL data were included', 'Patients who awoke or died prior to 36 hours postarrest were excluded', 'After Cardiac Arrest']",[],"['EEG Patterns and Serum Neurofilament Light', 'NfL levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]",[],"[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.119407,"Patients with highly malignant EEG patterns had 2.9 times higher NfL levels than patients with malignant patterns and NfL levels were 13 times higher in patients with malignant patterns than those with benign patterns (95% CI 1.4-6.1 and 6.5-26.2, respectively; effect size 0.47;  p  < 0.001).","[{'ForeName': 'Linnéa', 'Initials': 'L', 'LastName': 'Grindegård', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China. linnea.grindegard@med.lu.se.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Cronberg', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Backman', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Dankiewicz', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Troels W', 'Initials': 'TW', 'LastName': 'Kjaer', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjaergaard', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kuiper', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Mattsson-Carlgren', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Anne-Fleur', 'Initials': 'AF', 'LastName': 'van Rootselaar', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Andrea O', 'Initials': 'AO', 'LastName': 'Rossetti', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Stammet', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Ullén', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Westhall', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Moseby-Knappe', 'Affiliation': 'From Neurology (L.G., T.C., N.M.-C., M.M.-K.), Clinical Neurophysiology (S.B., E.W.), Cardiology (J.D.), and Anaesthesia and Intensive Care (H.F.), Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö; Department of Psychiatry and Neurochemistry (K.B., H.Z.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg; Clinical Neurochemistry Laboratory (K.B., H.Z.), Sahlgrenska University Hospital, Mölndal, Sweden; Department of Cardiology (C.H.), Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Denmark; Departments of Intensive Care (J.H.) and Neurology/Clinical Neurophysiology (A.-F-V.R.), Amsterdam Neuroscience, Amsterdam UMC, Academic Medical Center, University of Amsterdam, the Netherlands; Departments of Clinical Neurophysiology (T.W.K.) and Cardiology (J.K.), Rigshospitalet University Hospital, Copenhagen, Denmark; Department of Intensive Care (M.K.), Medical Center Leeuwarden, the Netherlands; Clinical Memory Research Unit, Faculty of Medicine (N.M.-C.), and Wallenberg Centre for Molecular Medicine (N.M.-C.), Lund University; Anaesthesia and Intensive Care, Department of Clinical Sciences Lund (N.N.), Lund University, Helsingborg Hospital, Sweden; Department of Neurology (A.O.R.), CHUV and University of Lausanne, Switzerland; Department of Anesthesia and Intensive Care (P.S.), Centre Hospitalier de Luxembourg; Department of Life Sciences and Medicine (P.S.), Faculty of Science, Technology and Medicine, University of Luxembourg; Clinical Studies Sweden (S.U.), Skåne University Hospital, Lund; Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology; UK Dementia Research Institute at UCL (H.Z.), London, UK; and Hong Kong Center for Neurodegenerative Diseases (H.Z.), China.'}]",Neurology,['10.1212/WNL.0000000000200335']
1679,35696698,"Evaluating the Effect of Duloxetine Premedication on Postoperative Analgesic Requirement in Patients undergoing Laparoscopic Cholecystectomies: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study.","OBJECTIVE


The aim was to assess the effect of oral administration of preoperative duloxetine on postoperative pain and total analgesic requirement in the postoperative period as the primary objective. The secondary objective was to assess the perioperative hemodynamic parameters, sedation scores, demographic data and incidence of side effects (if any) in patients undergoing laparoscopic cholecystectomy.
METHODS


This was a prospective, randomized, double blind, placebo-controlled study conducted in a tertiary level medical college on 60 patients of either gender posted for laparoscopic cholecystectomies with American Society of Anesthesiologists (ASA) I and II. The patients were divided into two groups (n=30), received duloxetine 60 mg capsules and placebo capsules (Becosules) 2 hours before surgery.
RESULTS


The total requirement of both first and second rescue analgesic was higher in placebo as compared to duloxetine and found to be significant (P<0.05). The difference in mean Visual Analogue Scale (VAS) score was significantly (P<0.001) higher in placebo as compared to duloxetine at all time intervals postoperatively 0 mins (7.6±0.7 vs. 4.6±0.8); 15 mins (5.9±0.8 vs. 4.2±1.0); 30 mins (4.4±0.5 vs. 3.6±0.9); 4 hrs (6.6±0.06 vs. 5.3±1.3); 8 hrs (5.2±1.2 vs. 3.9±1.0) and 12 hrs (5.1±1.3 vs. 2.3±0.7). The mean arterial blood pressure (MAP) and heart rate (HR) was significantly higher in placebo compared to duloxetine in most of the time intervals in perioperative period. There was no significant difference in the sedation score between the groups except the 30 mins and 8 hours post operative.
DISCUSSION


Preoperative oral Duloxetine during laparoscopic cholecystectomy could reduce postoperative pain, postoperative analgesic requirements and better optimization of hemodynamics without causing major side effects.",2022,The mean arterial blood pressure (MAP) and heart rate (HR) was significantly higher in placebo compared to duloxetine in most of the time intervals in perioperative period.,"['Patients undergoing Laparoscopic Cholecystectomies', 'tertiary level medical college on 60 patients of either gender posted for laparoscopic cholecystectomies with American Society of Anesthesiologists (ASA) I and II', 'patients undergoing laparoscopic cholecystectomy']","['preoperative duloxetine', 'Duloxetine', 'Duloxetine Premedication', 'duloxetine 60\xa0mg capsules and placebo capsules (Becosules) 2 hours before surgery', 'duloxetine', 'placebo', 'Placebo']","['mean Visual Analogue Scale (VAS) score', 'perioperative hemodynamic parameters, sedation scores, demographic data and incidence of side effects', 'total requirement of both first and second rescue analgesic', 'sedation score', 'Postoperative Analgesic Requirement', 'postoperative pain, postoperative analgesic requirements', 'postoperative pain and total analgesic requirement', 'mean arterial blood pressure (MAP) and heart rate (HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C1667738', 'cui_str': 'duloxetine 60 MG'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292425', 'cui_str': '2 hours'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.279344,The mean arterial blood pressure (MAP) and heart rate (HR) was significantly higher in placebo compared to duloxetine in most of the time intervals in perioperative period.,"[{'ForeName': 'Shivika', 'Initials': 'S', 'LastName': 'Nath', 'Affiliation': 'Assistant Professor.'}, {'ForeName': 'Ambhrin', 'Initials': 'A', 'LastName': 'Saha', 'Affiliation': 'Second Year Post Graduate Student, HOD and Professor, Department of Anaesthesia, School of Medical Sciences and Research, Sharda University, Greater Noida, India.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': '■■■■.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000001052']
1680,35696684,"Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery : A Randomized Clinical Trial.","BACKGROUND


The REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) trial found similar ambulation and survival at 60 days with spinal versus general anesthesia for hip fracture surgery. Trial outcomes evaluating pain, prescription analgesic use, and patient satisfaction have not yet been reported.
OBJECTIVE


To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia.
DESIGN


Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505).
SETTING


46 U.S. and Canadian hospitals.
PARTICIPANTS


Patients aged 50 years or older undergoing hip fracture surgery.
INTERVENTION


Spinal or general anesthesia.
MEASUREMENTS


Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care.
RESULTS


A total of 1600 patients were enrolled. The average age was 78 years, and 77% were women. A total of 73.5% (1050 of 1428) of patients reported severe pain during the first 24 hours after surgery. Worst pain over the first 24 hours after surgery was greater with spinal anesthesia (rated from 0 [no pain] to 10 [worst pain imaginable]; mean difference, 0.40 [95% CI, 0.12 to 0.68]). Pain did not differ across groups at other time points. Prescription analgesic use at 60 days occurred in 25% (141 of 563) and 18.8% (108 of 574) of patients assigned to spinal and general anesthesia, respectively (relative risk, 1.33 [CI, 1.06 to 1.65]). Satisfaction was similar across groups.
LIMITATION


Missing outcome data and multiple outcomes assessed.
CONCLUSION


Severe pain is common after hip fracture. Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia.
PRIMARY FUNDING SOURCE


Patient-Centered Outcomes Research Institute .",2022,"Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia.
","['The average age was 78 years, and 77% were women', 'Patients aged 50 years or older undergoing hip fracture surgery', 'Hip Fracture Surgery ', '1600 patients were enrolled', 'hip fracture surgery', '46 U.S. and Canadian hospitals']","['Spinal or general anesthesia', 'Spinal Versus General Anesthesia']","['Severe pain', 'Worst pain', 'pain', 'Satisfaction', 'severe pain', 'pain, analgesic use, and satisfaction', 'Pain, Analgesic Use, and Patient Satisfaction', 'Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care', 'Pain', 'Prescription analgesic use', 'pain, prescription analgesic use, and patient satisfaction']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",1600.0,0.306814,"Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia.
","[{'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Neuman', 'Affiliation': 'Department of Anesthesiology and Critical Care, Perelman School of Medicine, and Center for Perioperative Outcomes Research and Transformation, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (M.D.N., N.E., L.J.G.).'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (R.F., S.S.E.).'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (R.F., S.S.E.).'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Sieber', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Medical Institutions, Baltimore, Maryland (F.S.).'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S., S.Ayad, M.H.).'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Magaziner', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland (J.M.).'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Elkassabany', 'Affiliation': 'Department of Anesthesiology and Critical Care, Perelman School of Medicine, and Center for Perioperative Outcomes Research and Transformation, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (M.D.N., N.E., L.J.G.).'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Schwenk', 'Affiliation': 'Department of Anesthesiology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (E.S.S.).'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Dillane', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Alberta Hospital, Edmonton, Alberta, Canada (D.Dillane).'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Marcantonio', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts (E.R.M.).'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Menio', 'Affiliation': 'Center for Advocacy for the Rights and Interests of the Elderly, Philadelphia, Pennsylvania (D.M.).'}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S., S.Ayad, M.H.).'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Hassan', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (D.I.S., S.Ayad, M.H.).'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Stone', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, Vancouver, British Columbia, Canada (T.S.).'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Papp', 'Affiliation': 'Division of Orthopaedics, Ottawa Hospital Civic Campus, Ottawa, Ontario, Canada (S.P.).'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Donegan', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (D.Donegan).'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'Department of Anesthesiology, New York University Langone Medical Center, New York, New York (M.M.).'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Jaffe', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina (J.D.J.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Luke', 'Affiliation': 'Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (C.L.).'}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesiology, Lahey Hospital and Medical Center, Burlington, Massachusetts (B.S.).'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Azim', 'Affiliation': 'Department of Anesthesiology, Stony Brook University, Stony Brook, New York (S.Azim).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hymes', 'Affiliation': 'Department of Orthopedic Surgery, Inova Fairfax Medical Campus, Falls Church, Virginia (R.H.).'}, {'ForeName': 'Ki-Jinn', 'Initials': 'KJ', 'LastName': 'Chin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada (K.C.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sheppard', 'Affiliation': 'Department of Anesthesiology, Hartford Hospital, Hartford, Connecticut (R.S.).'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Perlman', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon (B.P.).'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Sappenfield', 'Affiliation': 'Department of Anesthesiology, University of Florida College of Medicine, Gainesville, Florida (J.S.).'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Hauck', 'Affiliation': 'Department of Anesthesiology, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania (E.H.).'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Hoeft', 'Affiliation': 'Department of Anesthesiology, University of Vermont Larner College of Medicine, Burlington, Vermont (M.A.H.).'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Tierney', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (A.T., T.B., J.D.).'}, {'ForeName': 'Lakisha J', 'Initials': 'LJ', 'LastName': 'Gaskins', 'Affiliation': 'Department of Anesthesiology and Critical Care, Perelman School of Medicine, and Center for Perioperative Outcomes Research and Transformation, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (M.D.N., N.E., L.J.G.).'}, {'ForeName': 'Annamarie D', 'Initials': 'AD', 'LastName': 'Horan', 'Affiliation': 'Department of Anesthesiology and Critical Care, Perelman School of Medicine, and Department of Orthopaedic Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (A.D.H.).'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Brown', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (A.T., T.B., J.D.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dattilo', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (A.T., T.B., J.D.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Carson', 'Affiliation': 'Division of General Internal Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey (J.L.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M22-0320']
1681,35697127,Cap-assisted endoscopic mucosal resection versus standard inject and cut endoscopic mucosal resection for large colonic laterally spreading tumors treatment: a randomized multicenter study (with video).,"BACKGROUND AND AIMS


Piecemeal endoscopic mucosal resection (EMR) of laterally spreading colorectal lesions (LSTs) >20mm is effective. There is limited experience using cap-assisted EMR (EMR-C) for resection of colonic lesions. We compared the efficacy and the safety of the EMR-C for the removal of colonic LSTs ≥30mm with ""inject-and-cut"" or standard EMR (EMR-S).
METHODS


Randomized trial from 4 Italian centers. One hundred and thirty-eight patients were treated with EMR-C and 102 with EMR-S. The rate of residual lesions, percentage of recurrence after 12 months and adverse events were evaluated.
RESULTS


A total of 143 lesions were resected with EMR-C and 102 with EMR-S. Argon plasma coagulation (APC) was used as adjunctive treatment in 2.9% of EMR-C and in 22.5% of EMR-S (p<0.001). Median time required was 20 min for EMR-C and 30min for EMR-S (p<0.001).Adverse events (AEs) occurred in 14 (10.1%) EMR-C (2 perforations, 11 bleeding and 1 stenosis) and in 22 (21.6%) EMR-S (1 perforation and 21 bleeding) (p=0.017). Intra-procedural AEs occurred in 3.6% of EMR-C and in 16.7% of EMR-S (p=0.001).Overall, residual lesions within 12 months were found significantly higher with EMR-S (32 patients, 31.4%), than with EMR-C (8 patients, 5.8%) (p<0.001). Recurrence at follow up colonoscopy in 12 months occurred in 7 (5.1%) EMR-C and in 17 (16.7%) EMR-S (p<0.001).
CONCLUSIONS


The study demonstrated the feasibility and safety of EMR-C for removing large colorectal LSTs, with higher eradication rate, shorter resection time and less use of APC when compared to EMR-S.",2022,"The study demonstrated the feasibility and safety of EMR-C for removing large colorectal LSTs, with higher eradication rate, shorter resection time and less use of APC when compared to EMR-S.",['4 Italian centers'],"['endoscopic mucosal resection (EMR) of laterally spreading colorectal lesions (LSTs', 'Cap-assisted endoscopic mucosal resection versus standard inject and cut endoscopic mucosal resection', 'EMR-S. Argon plasma coagulation (APC', 'EMR-C', 'inject-and-cut"" or standard EMR', 'cap-assisted EMR (EMR-C', 'EMR-S']","['adverse events', 'Recurrence', 'rate of residual lesions, percentage of recurrence', 'EMR-S (1 perforation and 21 bleeding', 'Median time', 'Intra-procedural AEs']","[{'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1700928', 'cui_str': 'Strip Biopsy'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1700928', 'cui_str': 'Strip Biopsy'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",143.0,0.037505,"The study demonstrated the feasibility and safety of EMR-C for removing large colorectal LSTs, with higher eradication rate, shorter resection time and less use of APC when compared to EMR-S.","[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Conio', 'Affiliation': 'Massimo Conio, MD, Gastroenterology Department, Santa Corona General Hospital, Pietra, Ligure (SV), ASL2 Savonese, Italy; Polyclinique St George, Nice, France; Massimo Conio, MD, Gastroenterology Department, Santa Corona General Hospital, Pietra, Ligure (SV), ASL2 Savonese, Italy; Polyclinique St George, Nice, France.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Manta', 'Affiliation': 'Raffaele Manta: Gastroenterology and Digestive Endoscopy Department, General Hospital, 06129, Perugia, Italy.'}, {'ForeName': 'Rosa Angela', 'Initials': 'RA', 'LastName': 'Filiberti', 'Affiliation': 'Rosa Angela Filiberti: Clinical Epidemiology Unit, Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Todd H', 'Initials': 'TH', 'LastName': 'Baron', 'Affiliation': 'Todd H. Baron: Division of Gastroenterology and Hepatology, University of North Carolina at, Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Pasquale', 'Affiliation': 'Luigi Pasquale: Gastroenterology and Digestive Endoscopy Department, O. Frangipane Hospital, Ariano Irpino (AV), ASL Avellino, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Marini', 'Affiliation': 'Mario Marini: Gastroenterology and Operative Endoscopy Unit, Santa Maria Alle Scotte Hospital, Siena, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'De Ceglie', 'Affiliation': 'Antonella De Ceglie, Gastroenterology Department, Sanremo General Hospital, Sanremo (IM), ASL1 Imperiese, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2022.06.002']
1682,35697087,Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): randomized controlled trial.,"BACKGROUND


Insomnia in depression is common and difficult to resolve. Unresolved depression-related sleep disturbances increase risk of relapse at high costs for individuals and society. Trials have suggested music for insomnia in various populations, but there is little research on the effectiveness of music for depression-related insomnia.
METHODS


We examined the efficacy of a music intervention on insomnia, depression symptoms and quality of life in adults with depression-related insomnia. A two-armed randomized controlled trial was conducted, including depression outpatients with insomnia ( n  = 112) in a 1:1 ratio to music intervention and waitlist control group. The intervention group listened to music at bedtime for 4 weeks. Participants received treatment as usual during 8 weeks with assessments at baseline, at 4 and 8 weeks. The primary outcome measure was Pittsburgh Sleep Quality Index (PSQI), secondary outcomes comprised Actigraphy, the Hamilton Depression Rating Scale (HAMD-17) and World Health Organisation well-being questionnaires (WHO-5, WHOQOL-BREF).
RESULTS


The music intervention group experienced significant improvements in sleep quality and well-being at 4 weeks according to global PSQI scores (effect size = -2.1, 95%CI -3.3; -0.9) and WHO-5 scores (effect size 8.4, 95%CI 2.7;14.0). At 8 weeks, i.e. 4 weeks after termination of the music intervention, the improvement in global PSQI scores had decreased (effect size = -0.1, 95%CI -1.3; 1.1). Actigraphy sleep assessments showed no changes and there was no detection of change in depression symptoms.
CONCLUSIONS


Music intervention is suggested as a safe and moderately effective sleep aid in depression-related insomnia.  Trial registration:  Clinicaltrials.gov. ID NCT03676491.",2022,"The music intervention group experienced significant improvements in sleep quality and well-being at 4 weeks according to global PSQI scores (effect size = -2.1, 95%CI -3.3; -0.9) and WHO-5 scores (effect size 8.4, 95%CI 2.7;14.0).","['adults with depression-related insomnia', 'depression outpatients with insomnia ( n \u2009=\u2009112) in a 1:1 ratio to', 'adults with depression-related insomnia (MUSTAFI']","['Music intervention', 'music intervention and waitlist control group', 'Music', 'music intervention']","['depression symptoms', 'global PSQI scores', 'sleep quality and well-being at 4 weeks according to global PSQI scores', 'Pittsburgh Sleep Quality Index (PSQI), secondary outcomes comprised Actigraphy, the Hamilton Depression Rating Scale (HAMD-17) and World Health Organisation well-being questionnaires (WHO-5, WHOQOL-BREF', 'sleep quality', 'WHO-5 scores', 'insomnia, depression symptoms and quality of life', 'Actigraphy sleep assessments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0043236', 'cui_str': 'Worldwide Health'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.208476,"The music intervention group experienced significant improvements in sleep quality and well-being at 4 weeks according to global PSQI scores (effect size = -2.1, 95%CI -3.3; -0.9) and WHO-5 scores (effect size 8.4, 95%CI 2.7;14.0).","[{'ForeName': 'Helle Nystrup', 'Initials': 'HN', 'LastName': 'Lund', 'Affiliation': 'Unit for Psychiatric Research, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Inge Nygaard', 'Initials': 'IN', 'LastName': 'Pedersen', 'Affiliation': 'Music Therapy Clinic, Aalborg University Hospital, Psychiatry, Aalborg, Denmark.'}, {'ForeName': 'Agnieszka M', 'Initials': 'AM', 'LastName': 'Heymann-Szlachcinska', 'Affiliation': 'Unit for Anxiety and Obsession, Aalborg University Hospital, Psychiatry, Aalborg, Denmark.'}, {'ForeName': 'Maryla', 'Initials': 'M', 'LastName': 'Tuszewska', 'Affiliation': 'Department for Child and Adolescent Psychiatry, Aalborg University Hospital, Psychiatry, Aalborg, Denmark.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Bizik', 'Affiliation': 'Unit for Depression, Aalborg University Hospital, Psychiatry, Aalborg, Denmark.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Larsen', 'Affiliation': 'Unit for Depression, Aalborg University Hospital, Psychiatry, Aalborg, Denmark.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Drago', 'Affiliation': 'Unit for Depression, Aalborg University Hospital, Psychiatry, Aalborg, Denmark.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Kulhay', 'Affiliation': 'Unit for Depression, Aalborg University Hospital, Psychiatry, Aalborg, Denmark.'}, {'ForeName': 'Anelia', 'Initials': 'A', 'LastName': 'Larsen', 'Affiliation': 'Unit for Depression, Aalborg University Hospital, Psychiatry, Aalborg, Denmark.'}, {'ForeName': 'Helle Østermark', 'Initials': 'HØ', 'LastName': 'Sørensen', 'Affiliation': 'Unit for Psychiatric Research, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Grønbech', 'Affiliation': 'Unit for Psychiatric Research, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Lars Rye', 'Initials': 'LR', 'LastName': 'Bertelsen', 'Affiliation': 'Music Therapy Clinic, Aalborg University Hospital, Psychiatry, Aalborg, Denmark.'}, {'ForeName': 'Jan Brink', 'Initials': 'JB', 'LastName': 'Valentin', 'Affiliation': 'Danish Center for Clinical Health Services Research, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mainz', 'Affiliation': 'Danish Center for Clinical Health Services Research, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Søren Paaske', 'Initials': 'SP', 'LastName': 'Johnsen', 'Affiliation': 'Danish Center for Clinical Health Services Research, Aalborg University, Aalborg, Denmark.'}]",Nordic journal of psychiatry,['10.1080/08039488.2022.2080254']
1683,35697065,Menthacarin for long-term treatment of functional dyspepsia - Results from a clinical trial follow-up.,"BACKGROUND


Menthacarin was shown to be effective and safe in clinical trials in patients with functional dyspepsia (FD). Long-term treatment results have not been reported yet.
METHODS


An open-label, 11-month follow-up (FU) was offered to FD patients who had undergone treatment with Menthacarin (1 gastro-resistant capsule b.i.d. vs. placebo (PL)) in a 4-week, double-blind, clinical trial. During FU, all patients (former verum and PL) were treated with 1 gastro-resistant capsule Menthacarin b.i.d. Main outcomes were the changes in pain intensity and severity of sensation of pressure, heaviness, and fullness from original baseline and global improvement.
RESULTS


70 patients were included in the analyses (former Menthacarin group: 36, former PL group: 34). At the end of the PL-controlled study phase, all 3 main efficacy variables were statistically significantly improved in the Menthacarin group compared to PL. In the FU phase, former PL patients started to improve under Menthacarin treatment towards the outcomes seen in the former Menthacarin group (alignment at approximately 6 months), while former Menthacarin patients showed sustained or even continuously improved outcomes by month 12. At study end, more than 90% of patients were ""much or very much improved"" in both groups. Menthacarin treatment was well tolerated.
CONCLUSIONS


The favorable effects seen in the FU period suggest that Menthacarin is a valuable treatment option in FD patients who require symptomatic treatment also in the longer term for up to 12 months.",2022,"At the end of the PL-controlled study phase, all 3 main efficacy variables were statistically significantly improved in the Menthacarin group compared to PL.","['70 patients were included in the analyses (former Menthacarin group: 36, former PL group: 34', 'FD patients who had undergone treatment with Menthacarin (1 gastro-resistant capsule b.i.d', 'FD patients who require symptomatic treatment also in the longer term for up to 12 months', 'patients with functional dyspepsia (FD']","['placebo (PL', 'Menthacarin']","['pain intensity and severity of sensation of pressure, heaviness, and fullness from original baseline and global improvement', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0234222', 'cui_str': 'Baresthesia'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",70.0,0.14426,"At the end of the PL-controlled study phase, all 3 main efficacy variables were statistically significantly improved in the Menthacarin group compared to PL.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Storr', 'Affiliation': 'Zentrum für Endoskopie, Starnberg, Germany und Medizinische Klinik und Poliklinik II, Klinikum Großhadern, München, Germany.'}, {'ForeName': 'Berenike', 'Initials': 'B', 'LastName': 'Stracke', 'Affiliation': 'Global Medical Affairs, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.'}]",Zeitschrift fur Gastroenterologie,['10.1055/a-1823-1333']
1684,35697040,A Safety Analysis of Programmed Death 1 Pathway Inhibitors in Patients With Solid Tumor Malignancies and Preexisting Autoimmune Disease.,"OBJECTIVE


The aim of this study was to characterize the safety of programmed death 1 inhibitors in patients with preexisting autoimmune disease.
METHODS


A medical records review study was conducted on adults with solid tumor malignancies who received ≥1 dose of pembrolizumab or nivolumab at Emory Healthcare from September 4, 2014 until December 31, 2019. All autoimmune patients were included (n = 77), whereas the nonautoimmune patients were randomized and the first 156 patients were included in a 2:1 ratio to autoimmune patients. The primary objective was the comparison of incidence of immune-related adverse events (irAEs) between patients with preexisting autoimmune disease and those without. Secondary objectives included irAE characterization, irAE treatment, and survival analyses.
RESULTS


Preexisting autoimmune disease was controlled in all of the autoimmune patients before immunotherapy initiation. The rate of irAE was 32.7% in the nonautoimmune group and 42.9% in the autoimmune group (odds ratio, 0.65; 95% confidence interval, 0.37-1.14; p = 0.130). In the patient population diagnosed with a rheumatologic autoimmune disease, 23.81% of irAEs were considered to be a flare of their preexisting autoimmune disease. Less patients in the autoimmune group experienced a grade ≥3 irAE (21.21% vs 37.25%, p = 0.379) and received systemic corticosteroids (54.55% vs 67.35%, p = 0.241) for the treatment of the irAE.
CONCLUSIONS


These results suggest that pembrolizumab and nivolumab can be safely administered in patients with controlled preexisting autoimmune diseases without a significant increase in irAE compared with patients without autoimmune diseases. Inclusion of patients with preexisting autoimmune diseases in prospective clinical trials is warranted.",2022,"Less patients in the autoimmune group experienced a grade ≥3 irAE (21.21% vs 37.25%, p = 0.379) and received systemic corticosteroids (54.55% vs 67.35%, p = 0.241) for the treatment of the irAE.
","['adults with solid tumor malignancies who received ≥1 dose of pembrolizumab or nivolumab at Emory Healthcare from September 4, 2014 until December 31, 2019', 'All autoimmune patients were included (n = 77), whereas the nonautoimmune patients were randomized and the first 156 patients were included in a 2:1 ratio to autoimmune patients', 'patients with preexisting autoimmune disease', 'Patients With Solid Tumor Malignancies and Preexisting Autoimmune Disease', 'patients with preexisting autoimmune disease and those without']",['pembrolizumab and nivolumab'],"['rate of irAE', 'grade ≥3 irAE', 'incidence of immune-related adverse events (irAEs', 'irAE characterization, irAE treatment, and survival analyses', 'systemic corticosteroids']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",156.0,0.120912,"Less patients in the autoimmune group experienced a grade ≥3 irAE (21.21% vs 37.25%, p = 0.379) and received systemic corticosteroids (54.55% vs 67.35%, p = 0.241) for the treatment of the irAE.
","[{'ForeName': 'Jordyn Paige', 'Initials': 'JP', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': 'Anh Viet', 'Initials': 'AV', 'LastName': 'Trinh', 'Affiliation': ""Department of Pharmaceutical Services, Emory St Joseph's Hospital.""}, {'ForeName': 'Marley L', 'Initials': 'ML', 'LastName': 'Watson', 'Affiliation': 'From the Department of Pharmaceutical Services, Emory University Hospital Midtown.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Beardslee', 'Affiliation': 'From the Department of Pharmaceutical Services, Emory University Hospital Midtown.'}, {'ForeName': 'Subir', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': 'Biostatistics Shared Resource.'}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Kudchadkar', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University.'}, {'ForeName': 'Suchita', 'Initials': 'S', 'LastName': 'Pakkala', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Waltuck', 'Affiliation': 'Department of Rheumatology, Emory Healthcare, Atlanta, GA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Momary', 'Affiliation': 'Department of Pharmacy Practice, Mercer University College of Pharmacy.'}, {'ForeName': 'Kristina F', 'Initials': 'KF', 'LastName': 'Byers', 'Affiliation': 'From the Department of Pharmaceutical Services, Emory University Hospital Midtown.'}]",Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases,['10.1097/RHU.0000000000001863']
1685,35697332,Safety and efficacy of vebicorvir administered with entecavir in treatment-naïve patients with chronic hepatitis B virus infection.,"BACKGROUND AND AIMS


Nucleos(t)ide reverse transcriptase inhibitors do not completely suppress hepatitis B virus (HBV) DNA in chronic HBV infection (cHBV). Vebicorvir (VBR) is an investigational core inhibitor which interferes with multiple aspects of HBV replication. This phase 2 trial (NCT03577171) evaluated the efficacy and safety of VBR in combination with entecavir (ETV) in treatment-naïve patients with cHBV.
METHODS


Hepatitis B ""e"" antigen positive, treatment-naïve patients without cirrhosis were randomised 1:1 in a double-blind manner, to once-daily VBR 300 mg+ETV 0.5 mg or placebo (PBO)+ETV for 24 weeks (W). The primary endpoint was change in mean log 10  HBV DNA from Baseline to W12 and W24.
RESULTS


All patients in both treatment groups (PBO+ETV: 12/12; VBR+ETV: 13/13) completed the study. At W12, VBR+ETV led to a greater mean (SD) reduction from Baseline in log 10  IU/mL HBV DNA (-4.45 [1.03]) vs PBO+ETV (-3.30 [1.18]; p=0.0077). At W24, VBR+ETV led to a greater reduction from Baseline in log 10  IU/mL HBV DNA (-5.33 [1.59]) vs PBO+ETV (-4.20 [0.98]; p=0.0084). Greater mean reductions in pregenomic RNA were observed at W12 and W24 in patients receiving VBR+ETV vs PBO+ETV (p<0.0001 and p<0.0001). Changes in viral antigens were similar in both groups. No drug interaction between VBR and ETV was observed. Two patients experienced HBV DNA rebound during treatment, with no resistance breakthrough detected. Safety of VBR+ETV was similar to PBO+ETV. All treatment-emergent adverse events and laboratory abnormalities were Grade 1/2. There were no deaths, serious AEs, or evidence of drug-induced liver injury.
CONCLUSIONS


In this 24-week study, VBR+ETV provided additive antiviral activity over PBO+ETV in treatment-naïve patients with cHBV with a favourable safety and tolerability profile.
LAY SUMMARY


Hepatitis B is a long-lasting viral infection of the liver. This study demonstrates that vebicorvir (a core inhibitor) with entecavir is generally safe, well tolerated, and demonstrates greater antiviral activity compared with entecavir alone in treatment-naïve patients chronically infected with hepatitis B virus. This study supports continued evaluation of vebicorvir in the treatment of chronic hepatitis B.
CLINICAL TRIAL NUMBER


NCT03577171.",2022,Greater mean reductions in pregenomic RNA were observed at W12 and W24 in patients receiving VBR+ETV vs PBO+ETV (p<0.0001 and p<0.0001).,"['treatment-naïve patients with chronic hepatitis B virus infection', 'naïve patients chronically infected with hepatitis B virus', 'Hepatitis B ""e"" antigen positive, treatment-naïve patients without cirrhosis', 'treatment-naïve patients with cHBV']","['vebicorvir', 'entecavir', 'entecavir (ETV', 'VBR 300 mg+ETV 0.5 mg or placebo', 'Vebicorvir (VBR']","['HBV DNA rebound', 'additive antiviral activity', 'Changes in viral antigens', 'antiviral activity', 'pregenomic RNA', 'efficacy and safety of VBR', 'change in mean log 10  HBV DNA', 'deaths, serious AEs, or evidence of drug-induced liver injury', 'Safety and efficacy']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003342', 'cui_str': 'Viral antigen'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0860207', 'cui_str': 'Drug-induced disorder of liver'}]",,0.126464,Greater mean reductions in pregenomic RNA were observed at W12 and W24 in patients receiving VBR+ETV vs PBO+ETV (p<0.0001 and p<0.0001).,"[{'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Sulkowski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: msulkowski@jhmi.edu.'}, {'ForeName': 'Kosh', 'Initials': 'K', 'LastName': 'Agarwal', 'Affiliation': ""Institute of Liver Studies, King's College Hospital, London, UK.""}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Office of Xiaoli Ma, Philadelphia, PA, USA.'}, {'ForeName': 'Tuan T', 'Initials': 'TT', 'LastName': 'Nguyen', 'Affiliation': 'T Nguyen Research and Education, Inc., San Diego, CA, USA.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Schiff', 'Affiliation': 'Schiff Center for Liver Diseases, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Hie-Won L', 'Initials': 'HL', 'LastName': 'Hann', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Dieterich', 'Affiliation': 'Department of Medicine, Division of Liver Diseases, Icahn School of Medicine, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Nahass', 'Affiliation': 'ID Care, Hillsborough, NJ, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Sing', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Sing Chan MD, New York, NY, USA.'}, {'ForeName': 'Steven-Huy B', 'Initials': 'SB', 'LastName': 'Han', 'Affiliation': 'Pfleger Liver Institute, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Gane', 'Affiliation': 'New Zealand Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bennett', 'Affiliation': 'Medical Associates Research Group, San Diego, CA, USA.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Alves', 'Affiliation': 'Assembly Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Evanchik', 'Affiliation': 'Assembly Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'Assembly Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Assembly Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Lopatin', 'Affiliation': 'Assembly Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Colonno', 'Affiliation': 'Assembly Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Assembly Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Knox', 'Affiliation': 'Assembly Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Luisa M', 'Initials': 'LM', 'LastName': 'Stamm', 'Affiliation': 'Assembly Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Bonacini', 'Affiliation': 'Quest Clinical Research, San Francisco, CA, USA.'}, {'ForeName': 'Ira M', 'Initials': 'IM', 'LastName': 'Jacobson', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Walid S', 'Initials': 'WS', 'LastName': 'Ayoub', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Weilert', 'Affiliation': 'Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Natarajan', 'Initials': 'N', 'LastName': 'Ravendhran', 'Affiliation': 'Gastrohealth, Catonsville, MD, USA.'}, {'ForeName': 'Alnoor', 'Initials': 'A', 'LastName': 'Ramji', 'Affiliation': 'GastroIntestinal Research Institute, Vancouver, Canada.'}, {'ForeName': 'Paul Yien', 'Initials': 'PY', 'LastName': 'Kwo', 'Affiliation': 'Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Elkhashab', 'Affiliation': 'Toronto Liver Centre, Toronto, Canada.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Hassanein', 'Affiliation': 'Southern California Research Center, Coronado, CA, USA.'}, {'ForeName': 'Ho S', 'Initials': 'HS', 'LastName': 'Bae', 'Affiliation': 'Asian Pacific Liver Center, Los Angeles, CA, USA.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Lalezari', 'Affiliation': 'Quest Clinical Research, San Francisco, CA, USA.'}, {'ForeName': 'Scott K', 'Initials': 'SK', 'LastName': 'Fung', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine and State Key Laboratory of Liver Research, Queen Mary Hospital, The University of Hong Kong, Hong Kong.'}]",Journal of hepatology,['10.1016/j.jhep.2022.05.027']
1686,35697297,Hands-on vs hands-off for prevention of perineal injury: a randomized clinical trial.,"OBJECTIVE


To test the hypothesis that in nulliparous women with singleton pregnancies at term, hands-off technique during spontaneous vaginal delivery would reduce the rate of perineal laceration METHODS: Parallel group non-blinded randomized clinical trial. Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted in labor and delivery room between 37 0/7 - 42 0/7 weeks of gestation were eligible, and were randomized in a 1:1 ratio to receive hands-off technique (intervention group) or hands-on technique during pushing in the second stage of labor. The primary outcome of perineal laceration (any degree). The effect of hands-off technique on each outcome was quantified as the relative risk (RR) with 95% confidence interval (CI).
RESULTS


70 women were enrolled in the trial. Perineal lacerations (any degree) occurred in 15/35 (42.9%) women in the intervention group, and 33/35 (94.3%) in the control group (RR 0.45, 95% CI 0.31 to 0.67). Hands-off technique was also associated with significantly decreased risk in the incidence of episiotomy (RR 0.36, 95% CI 0.14 to 0.88), first-degree (RR 0.41, 95% CI 0.20 to 0.87), and second-degree lacerations (RR 0.43, 95% CI 0.19 to 0.99). There was no significant between-group difference in third- and fourth-degree lacerations, but the trial was not powered for these outcomes.
CONCLUSION


In nulliparous women with singleton pregnancies at term, hands-off technique reduces the rate of perineal lacerations REGISTRATION NUMBER: NCT04860102.",2022,"In nulliparous women with singleton pregnancies at term, hands-off technique reduces the rate of perineal lacerations REGISTRATION NUMBER: NCT04860102.","['Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted in labor and delivery room between 37 0/7 - 42 0/7 weeks of gestation were eligible', 'nulliparous women with singleton pregnancies', '70 women were enrolled in the trial']",['hands-off technique (intervention group) or hands-on technique during pushing in the second stage of labor'],"['perineal laceration (any degree', 'Perineal lacerations', 'incidence of episiotomy', 'relative risk (RR']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0233260', 'cui_str': 'Vertex presentation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}]","[{'cui': 'C0240713', 'cui_str': 'Laceration of perineum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",70.0,0.495325,"In nulliparous women with singleton pregnancies at term, hands-off technique reduces the rate of perineal lacerations REGISTRATION NUMBER: NCT04860102.","[{'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Califano', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Diana', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Claudia Collà', 'Initials': 'CC', 'LastName': 'Ruvolo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ioffredo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Nappi', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Annella', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Gragnano', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy. Electronic address: elisabettagragnano@gmail.com.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Guida', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Zullo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Mariavittoria', 'Initials': 'M', 'LastName': 'Locci', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100675']
1687,35697280,Does acute exercise benefit emotion regulation? Electrophysiological evidence from affective ratings and implicit emotional effects on cognition.,"Negative affect impacts cognition, and sometimes may interfere with cognitive function. Furthermore, emotion regulation is thought to play an important role in easing the suffering from negative affect. However, whether acute exercise could ease the emotional interference caused by unconscious affect on cognitive control, remains to be investigated. To test this, we used behavioral measures combined with event-related potentials (ERPs) to specifically investigate (i) the impacts of negative affect evoked by implicit cues on conflict inhibition (Flanker task), and (ii) whether acute exercise could mitigate these effects. Furthermore, we examined (iii) the impact of acute exercise on frontal alpha asymmetry as an index of cognitive emotional down-regulation to emotional stressors. Forty young women (age range from 18 to 26) were randomly assigned to either a control group (n = 20) or an exercise group (n = 20), and a repeated-measures design with a space of one week between measures was conducted. Results demonstrated that negative Flanker trials produced larger N1 amplitude but smaller N200 amplitude than neutral trials; furthermore, acute exercise could mitigate emotional effects on N1. However, significant effects of acute exercise on the resting and responding frontal alpha asymmetry were not found. The distinct direction of the impacts of negative affect on cognition are discussed together with implications about the effects of attention allocation on exercise-enhanced emotion regulation.",2022,"Results demonstrated that negative Flanker trials produced larger N1 amplitude but smaller N200 amplitude than neutral trials; furthermore, acute exercise could mitigate emotional effects on N1.",['Forty young women (age range from 18 to 26'],"['exercise group', 'acute exercise', 'behavioral measures combined with event-related potentials (ERPs']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}]",[],40.0,0.0145951,"Results demonstrated that negative Flanker trials produced larger N1 amplitude but smaller N200 amplitude than neutral trials; furthermore, acute exercise could mitigate emotional effects on N1.","[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Yafeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Physical Education and Sport, Henan University, Kaifeng, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'School of Physical Education and Sport, Henan University, Kaifeng, China. Electronic address: 13503786123@163.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Franz', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand. Electronic address: lfranz@psy.otago.ac.nz.'}]",Biological psychology,['10.1016/j.biopsycho.2022.108375']
1688,35697255,Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings.,"BACKGROUND


Rivaroxaban monotherapy was noninferior to combination therapy (rivaroxaban plus antiplatelet therapy) in efficacy but superior in safety in the Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial. Among 2,215 patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), 1,378 had baseline creatinine clearance (CrCl) ≥50 mL/min and received 10 (underdose) or 15 mg/d (standard-dose) rivaroxaban. We aimed to assess the effects of rivaroxaban underdose on clinical outcomes.
METHODS


We assessed efficacy endpoint (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, and death from any cause) and major bleeding in the subgroup of patients with preserved renal function in the AFIRE trial.
RESULTS


Age ≥75 years, female sex, lower CrCl, heart failure, and percutaneous coronary intervention history were associated with the underdose prescription. The underdose group had a similar incidence of the efficacy endpoint (3.62 vs. 3.51% per patient-year;  p  = 0.871) and significantly lower incidence of major bleeding (0.82 vs. 2.17% per patient-year;  p  = 0.022) than the standard-dose group. In patients receiving monotherapy, the incidences of efficacy endpoint and major bleeding were similar between the groups, whereas in those receiving combination therapy, the incidence of major bleeding was significantly lower in the underdose group than that in the standard-dose group.
CONCLUSION


In patients with AF, stable CAD, and preserved renal function, rivaroxaban underdose was associated with similar rates of thrombotic events but a lower incidence of hemorrhagic events than the standard dose.
CLINICAL TRIAL REGISTRATION


AFIRE UMIN Clinical Trials Registry (https://www.umin.ac.jp/ctr/), number UMIN000016612, and ClinicalTrials.gov, number NCT02642419.",2022,"In patients receiving monotherapy, the incidences of efficacy endpoint and major bleeding were similar between the groups, whereas in those receiving combination therapy, the incidence of major bleeding was significantly lower in the underdose group than that in the standard-dose group.
","['Atrial Fibrillation with Stable Coronary Disease', '2,215 patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), 1,378 had baseline creatinine clearance (CrCl) ≥50\u2009mL/min and received 10 (underdose) or 15\u2009mg/d (standard-dose', 'Patients with Stable Coronary Artery Disease (AFIRE) trial', 'Age ≥75 years, female sex, lower CrCl, heart failure, and percutaneous coronary intervention history were associated with the underdose prescription']","['Rivaroxaban monotherapy', 'Rivaroxaban', 'rivaroxaban', 'combination therapy (rivaroxaban plus antiplatelet therapy']","['major bleeding', 'efficacy endpoint', 'efficacy endpoint and major bleeding', 'thrombotic events', 'efficacy endpoint (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, and death from any cause) and major bleeding', 'hemorrhagic events', 'incidence of major bleeding']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0239150', 'cui_str': 'Creatinine low'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1112363', 'cui_str': 'Underdose'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",2215.0,0.112872,"In patients receiving monotherapy, the incidences of efficacy endpoint and major bleeding were similar between the groups, whereas in those receiving combination therapy, the incidence of major bleeding was significantly lower in the underdose group than that in the standard-dose group.
","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kaikita', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Akao', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiovascular Medicine, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Matoba', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Cardiovascular Center, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Department of Cardiology, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of General Medicine and Primary Care, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'Kumamoto University, Kumamoto, Japan.'}]",Thrombosis and haemostasis,['10.1055/s-0042-1744543']
1689,35697250,Nomograms for primary mucinous ovarian cancer: A SEER population-based study.,"BACKGROUND


To develop predictive nomograms of overall survival (OS) and cancer-specific survival (CSS) in patients with primary mucinous ovarian cancer (PMOC).
METHODS


Patients diagnosed with PMOC from 2010 to 2015 were obtained from the Surveillance, Epidemiology, and End Results (SEER) database, and randomly divided into a training cohort and a validation cohort. Univariate and multivariate Cox regression analyses were conducted to identify the independent risk factors. Nomograms were constructed and then verified by calibration plots, the concordance index (C-index), and the area under the receiver operating characteristic curve (AUC).
RESULTS


A total of 991 patients with PMOC were enrolled and randomly divided into a training cohort (n=695) and a validation cohort (n=296) at a ratio of 7:3. Multivariate Cox regression analyses demonstrated that independent risk factors for OS included age, laterality, and American Joint Committee on Cancer (AJCC) stage. Independent risk factors for CSS included age, laterality, grade, and AJCC stage. Predictive nomograms for OS and CSS were developed with respective independent risk variables. In the training cohort, the C-index of the CSS and OS nomograms were 0.88 [95% confidence interval (CI): 0.84-0.92] and 0.85 (95% CI: 0.81-0.89), respectively. In the validation cohort, the C-index of the predictive CSS and OS nomograms were 0.86 (95% CI: 0.80-0.92) and 0.80 (95% CI: 0.74-0.87), respectively. The AUCs were higher in both cohorts. Furthermore, the calibration curves in both cohorts showed good consistency between the predicted results and the actual results.
CONCLUSION


The nomograms demonstrated good predictability for the survival of patients with PMOC, and could serve as an applicable tool to help clinicians improve treatment plans.",2022,"The nomograms demonstrated good predictability for the survival of patients with PMOC, and could serve as an applicable tool to help clinicians improve treatment plans.","['patients with primary mucinous ovarian cancer (PMOC', 'Patients diagnosed with PMOC from 2010 to 2015 were obtained from the Surveillance, Epidemiology, and End Results (SEER) database, and randomly divided into a training cohort and a validation cohort', 'primary mucinous ovarian cancer', '991 patients with PMOC']",[],['overall survival (OS) and cancer-specific survival (CSS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",991.0,0.183772,"The nomograms demonstrated good predictability for the survival of patients with PMOC, and could serve as an applicable tool to help clinicians improve treatment plans.","[{'ForeName': 'Xueling', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Wuxi Medical School, Jiangnan University, 1800 Lihu Avenue, Wuxi, Jiangsu 214000, P.R. China; Department of Obstetrics and Gynecology, Affiliated Hospital of Jiangnan University, 1000 Hefeng Road, Wuxi, Jiangsu 214000, P.R. China.'}, {'ForeName': 'Luxi', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Wuxi Medical School, Jiangnan University, 1800 Lihu Avenue, Wuxi, Jiangsu 214000, P.R. China; Department of Obstetrics and Gynecology, Affiliated Hospital of Jiangnan University, 1000 Hefeng Road, Wuxi, Jiangsu 214000, P.R. China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Wuxi Medical School, Jiangnan University, 1800 Lihu Avenue, Wuxi, Jiangsu 214000, P.R. China; Department of Obstetrics and Gynecology, Affiliated Hospital of Jiangnan University, 1000 Hefeng Road, Wuxi, Jiangsu 214000, P.R. China.'}, {'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital of Jiangnan University, 1000 Hefeng Road, Wuxi, Jiangsu 214000, P.R. China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital of Jiangnan University, 1000 Hefeng Road, Wuxi, Jiangsu 214000, P.R. China. Electronic address: 13915355849@163.com.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2022.102424']
1690,35697217,"Mixed methods study design, pre-analysis plan, process evaluation and baseline results of trailbridges in rural Rwanda.","We present a study design, pre-analysis plan, process evaluation and baseline results designed to establish the impact of trailbridges on health, education, agricultural and economic outcomes of households in rural Rwanda. This intervention and study is being implemented in communities that face barriers to socioeconomic development through periodic isolation caused by flooding. We describe a mixed methods approach to measure the impacts of these trailbridges on outcomes at the village level. The study is anchored on a stepped-wedge randomized controlled trial (RCT) implemented in 147 sites: 97 phased-in intervention sites and 50 long-term control sites. These sites are being monitored in four annual waves comprising of a baseline period and three subsequent follow-up waves. We will supplement the RCT with three sub-studies. First, we are investigating the role of weather events and streamflow variability on temporal and spatial bridge use patterns among intervention sites. We will then find the relationship between the weather events, streamflow and bridge use from motion-activated cameras installed in intervention sites. Secondly, we are following 42 markets serving study sites to investigate the impact of the trailbridges on the market prices of key goods including crops, livestock and agricultural inputs. Lastly, we are following 30 villages that are more distant from the river crossings to determine the spatial extent of the trailbridge impacts. Our study will advance knowledge by generating new data on the impact of rural infrastructure and providing the opportunity to explore a range of outcomes for future evaluation of infrastructure in low- and middle-income countries. We will enable an outcomes-based funding model that ties implementer payments to demonstrated positive impacts of these trailbridges. Furthermore, we will identify cost-effective, easily assessed measures that are highly correlated to the economic and health benefits of the intervention. These measures may then be used by a portfolio of interventions across multiple geographies without always requiring complex trials.",2022,We will enable an outcomes-based funding model that ties implementer payments to demonstrated positive impacts of these trailbridges.,"['147 sites: 97 phased-in intervention sites and 50 long-term control sites', 'trailbridges in rural Rwanda', 'households in rural Rwanda']",[],[],"[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0020052', 'cui_str': 'Households'}]",[],[],,0.0861491,We will enable an outcomes-based funding model that ties implementer payments to demonstrated positive impacts of these trailbridges.,"[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Macharia', 'Affiliation': 'Mortenson Center in Global Engineering, University of Colorado Boulder, 4001 Discovery Drive, Boulder, 80303, CO, USA; Regional Centre for Mapping of Resources for Development, Nairobi, Kenya.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'MacDonald', 'Affiliation': 'Mortenson Center in Global Engineering, University of Colorado Boulder, 4001 Discovery Drive, Boulder, 80303, CO, USA.'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Mugabo', 'Affiliation': 'Amazi Yego Ltd, Kigali, Rwanda.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Donovan', 'Affiliation': 'Yale School of Management, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Wyatt', 'Initials': 'W', 'LastName': 'Brooks', 'Affiliation': 'Department of Economics, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Sorenie', 'Initials': 'S', 'LastName': 'Gudissa', 'Affiliation': 'Yale School of Management, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Abbie', 'Initials': 'A', 'LastName': 'Noriega', 'Affiliation': 'Bridges to Prosperity, Denver, CO, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Barstow', 'Affiliation': 'Bridges to Prosperity, Denver, CO, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Dickinson', 'Affiliation': 'Environmental and Occupational Health, Colorado School of Public Health, Denver, CO, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Mortenson Center in Global Engineering, University of Colorado Boulder, 4001 Discovery Drive, Boulder, 80303, CO, USA. Electronic address: evan.thomas@colorado.edu.'}]",The Science of the total environment,['10.1016/j.scitotenv.2022.156546']
1691,35697146,The comparative effectiveness of COVID-19 monoclonal antibodies: A learning health system randomized clinical trial.,"BACKGROUND


Monoclonal antibodies (mAb) that neutralize SARS-CoV-2 decrease hospitalization and death compared to placebo in patients with mild to moderate COVID-19; however, comparative effectiveness is unknown. We report the comparative effectiveness of bamlanivimab, bamlanivimab-etesevimab, and casirivimab-imdevimab.
METHODS


A learning health system platform trial in a U.S. health system enrolled patients meeting mAb Emergency Use Authorization criteria. An electronic health record-embedded application linked local mAb inventory to patient encounters and provided random mAb allocation. Primary outcome was hospital-free days to day 28. Primary analysis was a Bayesian model adjusting for treatment location, age, sex, and time. Inferiority was defined as 99% posterior probability of an odds ratio < 1. Equivalence was defined as 95% posterior probability the odds ratio is within a given bound.
FINDINGS


Between March 10 and June 25, 2021, 1935 patients received treatment. Median hospital-free days were 28 (IQR 28, 28) for each mAb. Mortality was 0.8% (1/128), 0.8% (7/885), and 0.7% (6/922) for bamlanivimab, bamlanivimab-etesevimab, and casirivimab-imdevimab, respectively. Relative to casirivimab-imdevimab (n = 922), median adjusted odds ratios were 0.58 (95% credible interval [CI] 0.30-1.16) and 0.94 (95% CI 0.72-1.24) for bamlanivimab (n = 128) and bamlanivimab-etesevimab (n = 885), respectively. These odds ratios yielded 91% and 94% probabilities of inferiority of bamlanivimab versus bamlanivimab-etesevimab and casirivimab-imdevimab, and an 86% probability of equivalence between bamlanivimab-etesevimab and casirivimab-imdevimab.
INTERPRETATION


Among patients with mild to moderate COVID-19, bamlanivimab-etesevimab or casirivimab-imdevimab treatment resulted in 86% probability of equivalence. No treatment met prespecified criteria for statistical equivalence. Median hospital-free days to day 28 were 28 (IQR 28, 28) for each mAb.
FUNDING AND REGISTRATION


This work received no external funding. The U.S. government provided the reported mAb. This trial is registered at ClinicalTrials.gov, NCT04790786.",2022,"These odds ratios yielded 91% and 94% probabilities of inferiority of bamlanivimab versus bamlanivimab-etesevimab and casirivimab-imdevimab, and an 86% probability of equivalence between bamlanivimab-etesevimab and casirivimab-imdevimab.
","['Between March 10 and June 25, 2021, 1935 patients received treatment', 'patients with mild to moderate COVID-19', 'a U.S. health system enrolled patients meeting mAb Emergency Use Authorization criteria']","['COVID-19 monoclonal antibodies', 'bamlanivimab, bamlanivimab-etesevimab, and casirivimab-imdevimab', 'placebo']","['Mortality', 'Inferiority', 'hospital-free days to day 28', 'Median hospital-free days']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.457142,"These odds ratios yielded 91% and 94% probabilities of inferiority of bamlanivimab versus bamlanivimab-etesevimab and casirivimab-imdevimab, and an 86% probability of equivalence between bamlanivimab-etesevimab and casirivimab-imdevimab.
","[{'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'McCreary', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'J Ryan', 'Initials': 'JR', 'LastName': 'Bariola', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Tami E', 'Initials': 'TE', 'LastName': 'Minnier', 'Affiliation': 'Wolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Wadas', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Shovel', 'Affiliation': 'Wolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Albin', 'Affiliation': 'Supply Chain Management/HC Pharmacy, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Oscar C', 'Initials': 'OC', 'LastName': 'Marroquin', 'Affiliation': 'Clinical Analytics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Kip', 'Affiliation': 'Clinical Analytics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Collins', 'Affiliation': 'Clinical Analytics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schmidhofer', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Wisniewski', 'Affiliation': 'Wolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nace', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Sullivan', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Axe', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Meyers', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weissman', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Garrard', 'Affiliation': 'Clinical Analytics, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Octavia M', 'Initials': 'OM', 'LastName': 'Peck-Palmer', 'Affiliation': 'Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Bart', 'Affiliation': 'Health Services Division, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, Austin, TX, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, Austin, TX, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Crawford', 'Affiliation': 'Berry Consultants, Austin, TX, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothlin', 'Affiliation': 'Berry Consultants, Austin, TX, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Khadem', 'Affiliation': 'Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Linstrum', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Montgomery', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ricketts', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Kennedy', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Pidro', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Ghady', 'Initials': 'G', 'LastName': 'Haidar', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Graham M', 'Initials': 'GM', 'LastName': 'Snyder', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'McVerry', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nakayama', 'Affiliation': 'Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Zapf', 'Affiliation': 'Wolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Kip', 'Affiliation': 'Wolff Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Seymour', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Health System Office of Healthcare Innovation, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Huang', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: huangdt@upmc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106822']
1692,35697601,The psychophysiological influence of exertion and affect on sport-specific cognitive and physical performance.,"OBJECTIVES


The purpose of the present study was to examine differences in cognitive and physical performance, affective states, perceived exertion, and physiological responses between trials with cognitive, physical, or combined cognitive and physical load.
DESIGN


Randomised cross-over trial.
METHODS


Highly trained competitive orienteers (n = 15 men; n = 10 women) completed three randomised trials comprised of: (1) sport-specific cognitive tests; (2) 35-minute cycling time trial; and (3) combined sport-specific cognitive tests and 35-minute cycling time trial. Measures taken during the trials recorded affective states, perceived exertion, heart rate, blood lactate, cycling watts, as well as working memory, updating, planning and decision making.
RESULTS


No significant differences in cognitive performance accuracy were observed within or across trials although reaction times improved within trials and were fastest in the combined trial. Blood lactate, heart rate, perceived exertion, negative affective states, and watts were highest in the physical trial.
CONCLUSIONS


The combined load of undertaking sport-specific cognitive tests and a cycling time trial did not influence cognitive performance accuracy. Athletes produced greater watts when completing the physical task independently compared with the combined trial, however psychophysiological responses were worse. Further investigation is warranted to determine whether athletes' attentional focus underpins psychophysiological responses to dual-task sport performance.",2022,No significant differences in cognitive performance accuracy were observed within or across trials although reaction times improved within trials and were fastest in the combined trial.,['Highly trained competitive orienteers (n\u202f=\u202f15 men; n\u202f=\u202f10 women'],['sport-specific cognitive tests; (2) 35-minute cycling time trial; and (3) combined sport-specific cognitive tests'],"['sport-specific cognitive and physical performance', 'affective states, perceived exertion, heart rate, blood lactate, cycling watts, as well as working memory, updating, planning and decision making', 'cognitive and physical performance, affective states, perceived exertion, and physiological responses', 'Blood lactate, heart rate, perceived exertion, negative affective states, and watts', 'cognitive performance accuracy']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0439261', 'cui_str': 'watt'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",15.0,0.0697507,No significant differences in cognitive performance accuracy were observed within or across trials although reaction times improved within trials and were fastest in the combined trial.,"[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, Umeå University, Sweden; Umeå School of Sport Science, Umeå University, Sweden. Electronic address: paul.davis@umu.se.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sörman', 'Affiliation': 'Department of Engineering Psychology, Luleå Technical University, Sweden.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Carlberg', 'Affiliation': 'Department of Psychology, Umeå University, Sweden.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Rognsvåg', 'Affiliation': 'Department of Psychology, Umeå University, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stenling', 'Affiliation': 'Department of Psychology, Umeå University, Sweden; Umeå School of Sport Science, Umeå University, Sweden; Department of Sport Science and Physical Education, University of Agder, Norway.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2022.05.008']
1693,35697592,The efficacy of infrared filter window film to prevent hyperthermia in neonatal hyperbilirubinemia with conventional phototherapy: a randomized control trial.,"BACKGROUND


Phototherapy is the first-line treatment of neonatal hyperbilirubinemia. Possible side effects caused by phototherapy include hyperthermia and dehydration. Currently, there are many types of infrared blocking film for potential use in reducing infrared radiation exposure and preventing hyperthermia. This study aims to evaluate the efficacy of infrared blocking film in preventing hyperthermia during the first 24 h of phototherapy.
METHODS


The randomized controlled trial study was carried out in 44 newborns with hyperbilirubinemia. Infrared filter film with 75% visible light transmission and 90% infrared rejection was used in the study. Body temperature was measured for the assessment of the efficacy of filter film from axillary and rectal routes.
RESULTS


There was a significantly lower incidence of hyperthermia from the axillary temperature in the group with infrared blocking film compared to the control group (p = 0.031). The axillary temperature between before and after initiation of phototherapy in filter film group was significantly better (p = 0.008). According to efficacy of treatment, the study demonstrated that infrared filter film did not interfere with the efficacy of phototherapy in reducing bilirubin level.
CONCLUSIONS


The infrared filter film was significantly more effective in preventing hyperthermia from phototherapy in the first 24 h without causing any significant difference in reduction of bilirubin level.
THAI CLINICAL TRIALS REGISTRY


TCTR20190619001.",2022,"The infrared filter film was significantly more effective in preventing hyperthermia from phototherapy in the first 24 h without causing any significant difference in reduction of bilirubin level.
","['neonatal hyperbilirubinemia', '44 newborns with hyperbilirubinemia', 'neonatal hyperbilirubinemia with conventional phototherapy']","['infrared filter window film', 'infrared blocking film']","['hyperthermia and dehydration', 'bilirubin level', 'Body temperature', 'axillary temperature', 'reduction of bilirubin level', 'hyperthermia from the axillary temperature']","[{'cui': 'C0857007', 'cui_str': 'Neonatal hyperbilirubinemia'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1531924', 'cui_str': 'Axillary temperature'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",44.0,0.0523943,"The infrared filter film was significantly more effective in preventing hyperthermia from phototherapy in the first 24 h without causing any significant difference in reduction of bilirubin level.
","[{'ForeName': 'Arucha', 'Initials': 'A', 'LastName': 'Treesirichod', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Srinakharinwirot University, Thailand. Electronic address: Trees_ar@yahoo.com.'}, {'ForeName': 'Sutha', 'Initials': 'S', 'LastName': 'Eiamkulbutr', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Srinakharinwirot University, Thailand.'}, {'ForeName': 'Phakwan', 'Initials': 'P', 'LastName': 'Laohathai', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Srinakharinwirot University, Thailand.'}, {'ForeName': 'Kannikar', 'Initials': 'K', 'LastName': 'Vongbhavit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Srinakharinwirot University, Thailand.'}, {'ForeName': 'Jantana', 'Initials': 'J', 'LastName': 'Panburana', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Srinakharinwirot University, Thailand.'}]",Pediatrics and neonatology,['10.1016/j.pedneo.2021.12.014']
1694,35697571,Immunogenicity of a single 4CMenB vaccine booster in adolescents 11 years after childhood immunisation.,"The clinical development of the meningococcal vaccine, 4CMenB, included 2 doses in vaccine-naïve adolescents, which was considered unlikely to be cost-effective for implementation. Theoretically, priming with 4CMenB in early childhood might drive strong immune responses after only a single booster dose in adolescents and reduce programmatic costs. To address this question, children over 11 years old who took part in previous trials involving the administration of 3-5 doses of 4CMenB at infant/preschool age from 2006 were recruited into a post licensure single-centre trial, and were divided into two groups: those who received their last dose at 12 months old (infant group) and those who received their last dose at 3 years old (infant + preschool group). Naïve age-matched controls were randomised to receive one (adolescent 1 group) or two doses at days 0 and 28 (adolescent 2 group) of 4CMenB. Serum bactericidal antibody (SBA) assays using human complement were performed against three reference strains prior to vaccination, and at 1, 6 and 12 months. Previous vaccination was associated with a higher response to a single booster dose at 11 years of age, one-month post-vaccination, when compared with a single dose in naïve age-matched controls. At day 180, the highest responses were observed in participants in the infant + preschool group against strain 5/99 (GMT 316.1 [CI 158.4 to 630.8]), as compared with naïve adolescents who received two doses (GMTs 84.5 [CI 57.7 to 123.6]). When the last dose was received at 12-months of age, responses to a single adolescent dose were not as robust (GMT 61.1 [CI 14.8 to 252.4] to strain 5/99). This descriptive study indicates that the highest SBA responses after a single dose in adolescence were observed in participants who received a preschool dose, suggesting that B cell memory responses are not sufficiently primed at less than 12 months of age. Trial registration EudraCT 2017-004732-11, ISRCTN16774163.",2022,"Previous vaccination was associated with a higher response to a single booster dose at 11 years of age, one-month post-vaccination, when compared with a single dose in naïve age-matched controls.","['children over 11\xa0years old who took part in previous trials involving the administration of 3-5 doses of 4CMenB at infant/preschool age from 2006 were recruited into a post licensure single-centre trial', 'adolescents 11 years after childhood immunisation', 'Naïve age-matched controls']","['single 4CMenB vaccine booster', '4CMenB. Serum bactericidal antibody (SBA) assays using human complement were performed against three reference strains prior to vaccination']",['Immunogenicity'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023637', 'cui_str': 'Licensure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3490189', 'cui_str': '4CMenB vaccine'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.156222,"Previous vaccination was associated with a higher response to a single booster dose at 11 years of age, one-month post-vaccination, when compared with a single dose in naïve age-matched controls.","[{'ForeName': 'Christine S', 'Initials': 'CS', 'LastName': 'Rollier', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK. Electronic address: c.rollier@surrey.ac.uk.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Blackwell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Linder', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Silva-Reyes', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ford', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Holland', 'Affiliation': 'UK Health Security Agency, Vaccine Evaluation Unit, Manchester Royal Infirmary, M13 9WL Manchester, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'UK Health Security Agency, Vaccine Evaluation Unit, Manchester Royal Infirmary, M13 9WL Manchester, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Harbinson', 'Affiliation': 'UK Health Security Agency, Vaccine Evaluation Unit, Manchester Royal Infirmary, M13 9WL Manchester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'UK Health Security Agency, Vaccine Evaluation Unit, Manchester Royal Infirmary, M13 9WL Manchester, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford OX37LE, UK.'}]",Vaccine,['10.1016/j.vaccine.2022.04.085']
1695,35697559,Effectiveness of question prompt lists in patients with breast cancer: A randomized controlled trial.,"OBJECTIVES


To evaluate the effectiveness of a question prompt list (QPL) in decision self-efficacy, decision-making participation, patient-physician communication, decisional conflict or regret, and health status in patients with breast cancer.
METHODS


A total of 240 patients with breast cancer were randomly assigned to a QPL group or control group (n = 120 each). The intervention and control groups received an additional educational QPL booklet and routine care, respectively.
RESULTS


The intervention group exhibited significant improvements in decision self-efficacy, perceived patient-physician interactions, and patient-physician communication compared with the control group. Multilevel modeling analyses revealed significant group-time interaction effects on decision self-efficacy (β = 9.99, P < 0.01), perceived patient-physician interactions (β = 8.10, P < 0.01), patient-physician communication (β = 5.02, P < 0.01), and anxiety status (β = -3.78, P < 0.05). The QPL intervention exerted more favorable effects than routine care, with repeated measurements of the same patients and the data of patients under the care of the same surgeons accounted for.
CONCLUSIONS


The QPL intervention exerted multidimensional effects on decision-making outcomes among patients with breast cancer.
PRACTICAL IMPLICATIONS


Clinicians can integrate a QPL into routine care for patients with breast cancer.",2022,"The intervention group exhibited significant improvements in decision self-efficacy, perceived patient-physician interactions, and patient-physician communication compared with the control group.","['240 patients with breast cancer', 'patients with breast cancer']","['additional educational QPL booklet and routine care, respectively', 'QPL group or control group', 'QPL intervention', 'question prompt list (QPL']","['anxiety status ', 'decision self-efficacy, perceived patient-physician interactions, and patient-physician communication', 'perceived patient-physician interactions', 'patient-physician communication', 'decision self-efficacy']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031830', 'cui_str': 'Physician Patient Relations'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",240.0,0.0514155,"The intervention group exhibited significant improvements in decision self-efficacy, perceived patient-physician interactions, and patient-physician communication compared with the control group.","[{'ForeName': 'Pei-Shan', 'Initials': 'PS', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan; Department of Nursing, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan; Center for Nursing and Healthcare Research in Clinical Practice Application, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Chien', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Information Management, National Taipei University, New Taipei City, Taiwan.'}, {'ForeName': 'Yi-Hsuan', 'Initials': 'YH', 'LastName': 'Lan', 'Affiliation': 'School of Gerontology and Long-term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Han-Wei', 'Initials': 'HW', 'LastName': 'Tsai', 'Affiliation': 'School of Gerontology and Long-term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chin-Yin', 'Initials': 'CY', 'LastName': 'Hsiao', 'Affiliation': 'School of Gerontology and Long-term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Jeng-Cheng', 'Initials': 'JC', 'LastName': 'Wu', 'Affiliation': 'Department of Education, Taipei Medical University Hospital, Taipei, Taiwan; Department of Urology, Taipei Medical University Hospital, Taipei, Taiwan; Department of Urology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Shyr-Ming', 'Initials': 'SM', 'LastName': 'Sheen-Chen', 'Affiliation': 'Department of Surgery, Taipei Medical University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wen-Hsuan', 'Initials': 'WH', 'LastName': 'Hou', 'Affiliation': 'School of Gerontology and Long-term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan; Department of Education, Taipei Medical University Hospital, Taipei, Taiwan; Department of Physical Medicine & Rehabilitation, Taipei Medical University Hospital, Taipei, Taiwan; Department of Geriatric Medicine, Taipei Medical University Hospital, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan. Electronic address: houwh@tmu.edu.tw.'}]",Patient education and counseling,['10.1016/j.pec.2022.05.016']
1696,35689985,Intranasal oxytocin attenuates the effects of monetary feedback on procedural learning.,"Procedural learning is a vital brain function that allows us to acquire motor skills during development or re-learn them after lesions affecting the motor system. Procedural learning can be improved by feedback of different valence, e.g., monetary or social, mediated by dopaminergic circuits. While processing motivationally relevant stimuli, dopamine interacts closely with oxytocin, whose effects on procedural learning, particularly feedback-based approaches, remain poorly understood. In a randomized, double-blind, placebo-controlled trial, we investigated whether oxytocin modulates the differential effects of monetary and social feedback on procedural learning. Sixty-one healthy male participants were randomized to receive a placebo or oxytocin intranasally. The participants then performed a modified serial reaction time task. Oxytocin plasma concentrations were measured before and after applying the placebo or verum. Groups did not differ regarding general reaction times or measures of procedural learning. For the placebo group, monetary feedback improved procedural learning compared to a neutral control condition. In contrast, the oxytocin group did not show a differential effect of monetary or social feedback despite a significant increase in oxytocin plasma levels after intranasal application. The data suggest that oxytocin does not influence procedural learning per se. Instead, oxytocin seems to attenuate the effects of monetary feedback on procedural learning specifically.",2022,"In contrast, the oxytocin group did not show a differential effect of monetary or social feedback despite a significant increase in oxytocin plasma levels after intranasal application.",['Sixty-one healthy male participants'],"['placebo or oxytocin', 'placebo', 'Intranasal oxytocin', 'oxytocin']","['oxytocin plasma levels', 'procedural learning', 'Oxytocin plasma concentrations', 'general reaction times or measures of procedural learning', 'monetary feedback improved procedural learning']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4304298', 'cui_str': 'Procedural learning'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",61.0,0.164891,"In contrast, the oxytocin group did not show a differential effect of monetary or social feedback despite a significant increase in oxytocin plasma levels after intranasal application.","[{'ForeName': 'Christopher E J', 'Initials': 'CEJ', 'LastName': 'Doppler', 'Affiliation': 'Institute of Neuroscience and Medicine (INM-3), Forschungszentrum Jülich, Jülich, Germany; University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany. Electronic address: c.doppler@fz-juelich.de.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychiatry, Alexius/Josef Hospital, Neuss, Germany.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Seger', 'Affiliation': 'Institute of Neuroscience and Medicine (INM-3), Forschungszentrum Jülich, Jülich, Germany; University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Karges', 'Affiliation': 'Division of Endocrinology and Diabetes, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Weiss', 'Affiliation': 'Institute of Neuroscience and Medicine (INM-3), Forschungszentrum Jülich, Jülich, Germany; University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'Institute of Neuroscience and Medicine (INM-3), Forschungszentrum Jülich, Jülich, Germany; University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2022.105823']
1697,35689905,Smoking reduction among homeless smokers in a randomized controlled trial targeting cessation.,"INTRODUCTION


Homeless populations have high rates of smoking and unique barriers to quitting. General cessation strategies have been unsuccessful in this population. Smoking reduction may be a good intermediate goal. We conducted a secondary analysis to identify predictors of smoking reduction in a cohort of homeless smokers enrolled in a 26-week randomized clinical trial (RCT) targeting smoking cessation.
METHODS


Data are from an RCT comparing motivational interviewing counseling plus nicotine replacement therapy (NRT) to brief advice to quit (standard care) plus NRT among homeless smokers. Using bivariate analyses and multinomial logistic regression, we compared demographics, health and psychosocial variables, tobacco use, substance use, and NRT adherence among those who reported: quitting; reducing smoking by 50-99%; and not reducing smoking by 50%.
RESULTS


Of 324 participants who completed 26-week follow-up, 18.8% and 63.9% self-reported quitting and reducing, respectively. Compared to those who did not reduce smoking, participants reporting reducing indicated higher baseline cigarette use (OR=1.08; CI:1.04-1.12) and menthol use (OR=2.24; CI:1.05-4.77). Compared to participants who reduced, participants reporting quitting were more likely to be male (OR=1.998; CI:1.00-3.98), experience more housing instability (OR=1.97; CI:1.08-3.59), indicate higher importance of quitting (OR=1.27; CI:1.041.55), have higher NRT adherence (OR=1.75; CI:1.00-3.06), and lower odds of reported illicit drug use (OR=0.48; CI:0.24-0.95).
CONCLUSIONS


Over half of participants reduced smoking by at least 50%, indicating reduction is feasible among homeless smokers. Further research is required to understand the impact of reduction on future cessation attempts in homeless smokers. This study shows that reduction is achievable and may be a valid intermediate goal.",2022,"Compared to those who did not reduce smoking, participants reporting reducing indicated higher baseline cigarette use (OR=1.08; CI:1.04-1.12) and menthol use (OR=2.24; CI:1.05-4.77).","['homeless smokers', '324 participants']",['motivational interviewing counseling plus nicotine replacement therapy (NRT) to brief advice to quit (standard care) plus NRT'],"['housing instability', 'demographics, health and psychosocial variables, tobacco use, substance use, and NRT adherence', 'Smoking reduction', 'NRT adherence']","[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4517713', 'cui_str': '324'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",324.0,0.137817,"Compared to those who did not reduce smoking, participants reporting reducing indicated higher baseline cigarette use (OR=1.08; CI:1.04-1.12) and menthol use (OR=2.24; CI:1.05-4.77).","[{'ForeName': 'Manami', 'Initials': 'M', 'LastName': 'Bhattacharya', 'Affiliation': 'University of Minnesota, Department of Health Policy and Management, Minneapolis, MN 55455, USA. Electronic address: bhatt033@umn.edu.'}, {'ForeName': 'Olamide', 'Initials': 'O', 'LastName': 'Ojo-Fati', 'Affiliation': 'California Department of Public Health, Sacramento, CA, United States.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Everson-Rose', 'Affiliation': 'University of Minnesota, Department of Medicine, Minneapolis, MN, United States.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Thomas', 'Affiliation': 'University of Minnesota, Department of Medicine, Minneapolis, MN, United States.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'University of Minnesota, Department of Health Policy and Management, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Ogedegbe', 'Affiliation': 'New York University, Department of Population Health, New York, NY, United States.'}, {'ForeName': 'Girardin', 'Initials': 'G', 'LastName': 'Jean-Louis', 'Affiliation': 'New York University, Department of Population Health, New York, NY, United States.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Joseph', 'Affiliation': 'University of Minnesota, Department of Medicine, Minneapolis, MN, United States.'}, {'ForeName': 'Kolawole S', 'Initials': 'KS', 'LastName': 'Okuyemi', 'Affiliation': 'University of Utah, Department of Family & Preventive Medicine, Salt Lake City, UT, United States. Electronic address: kola.okuyemi@hsc.utah.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2022.107373']
1698,35690880,"HIV testing and linkage to ART following secondary distribution of HIV self-test kits to male partners of women living with HIV: a pilot randomized control trial in Mpumalanga, South Africa.","INTRODUCTION


South African men are underrepresented in HIV testing and treatment services. Secondary distribution of oral HIV self-test (HIVST) kits by women living with HIV (WLHIV) to their male partners (i.e. index partner HIVST) may increase men's testing and treatment but has been understudied.
METHODS


Between March and July 2021, we evaluated the effectiveness of index partner HIVST versus the standard of care (SOC) (invitations for men's facility-based testing) on men's testing in a 1:1 randomized control trial. Eligibility criteria included: WLHIV; ≥18 years of age; attending one of four high-density rural clinics; have a working cell phone; and self-reported having a primary male partner of unknown serostatus. The primary outcome was the proportion of WLHIV reporting that her partner tested for HIV within 3 months after enrolment.
RESULTS


We enrolled 180 WLHIV and 176 completed an endline survey (mean age = 35 years, 15% pregnant, 47% unmarried or non-cohabiting). In the HIVST arm, 78% of male partners were reported to have tested for HIV versus 55% in SOC (RR = 1.41; 95% CI = 1.14-1.76). In the HIVST arm, nine men were reactive with HIVST (14% positivity), six were confirmed HIV positive with standard testing (67%) and all of those started antiretroviral therapy (ART), and four HIV-negative men started pre-exposure prophylaxis (PrEP) (5%). In SOC, six men were diagnosed with HIV (12% positivity), 100% started ART and seven HIV-negative men started PrEP (16%). One case of verbal intimate partner violence was reported in the HIVST arm.
CONCLUSIONS


Secondary distribution of HIVST to partners of WLHIV was acceptable and effective for improving HIV testing among men in rural South Africa in our pilot study. Interventions are needed to link reactive HIVST users to confirmatory testing and ART.",2022,"CONCLUSIONS


Secondary distribution of HIVST to partners of WLHIV was acceptable and effective for improving HIV testing among men in rural South Africa in our pilot study.","['Between March and July 2021', 'South African men', 'nine men were reactive with HIVST (14% positivity), six were confirmed HIV positive with standard testing (67%) and all of those started antiretroviral therapy (ART), and four HIV-negative men started pre-exposure prophylaxis (PrEP) (5', 'Eligibility criteria included: WLHIV; ≥18 years of age; attending one of four high-density rural clinics; have a working cell phone; and self-reported having a primary male partner of unknown serostatus', 'Mpumalanga, South Africa', 'women living with HIV (WLHIV) to their male partners (i.e. index partner HIVST', 'male partners of women living with HIV', 'We enrolled 180 WLHIV and 176 completed an endline survey (mean age = 35 years, 15% pregnant, 47% unmarried or non-cohabiting']","[""index partner HIVST versus the standard of care (SOC) (invitations for men's facility-based testing"", 'HIVST']","['oral HIV self-test (HIVST) kits', 'proportion of WLHIV reporting that her partner tested for HIV', 'verbal intimate partner violence']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",6.0,0.17239,"CONCLUSIONS


Secondary distribution of HIVST to partners of WLHIV was acceptable and effective for improving HIV testing among men in rural South Africa in our pilot study.","[{'ForeName': 'Dvora L', 'Initials': 'DL', 'LastName': 'Joseph Davey', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Wall', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Nireshni', 'Initials': 'N', 'LastName': 'Naidoo', 'Affiliation': 'BroadReach Healthcare, Johannesburg, South Africa.'}, {'ForeName': 'Dhirisha', 'Initials': 'D', 'LastName': 'Naidoo', 'Affiliation': 'BroadReach Healthcare, Johannesburg, South Africa.'}, {'ForeName': 'Gugu', 'Initials': 'G', 'LastName': 'Xaba', 'Affiliation': 'BroadReach Healthcare, Johannesburg, South Africa.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Serao', 'Affiliation': 'BroadReach Healthcare, Johannesburg, South Africa.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Malone', 'Affiliation': 'BroadReach Healthcare, Johannesburg, South Africa.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dovel', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25937']
1699,35690876,Feasibility of an Intervention Targeting Health through Exergaming as an Alternative to Routine Treatment (FIT HEART): protocol for a non-randomised two-armed pilot study.,"BACKGROUND


Despite elevated risk of cardiometabolic disease among those with serious mental illness, and widespread recognition that physical activity interventions are required, there are multiple barriers to implementing typically recommended physical activity programmes in secure inpatient settings. Due to low mood, negative symptoms and poor socio-occupational functioning, psychiatric inpatients often lack motivation to engage in physical activity programmes. Moreover, regular access to outdoor spaces and exercise equipment is limited. As such, there is a need for novel physical activity interventions that are suitable for secure settings. This study aims to investigate the feasibility, acceptability and potential effectiveness of an intervention (exergaming) to promote physical activity among patients in a secure mental health setting.
METHODS


This non-randomised, two-arm pilot study will employ a pre-test/post-test parallel group design, comparing the exergaming intervention with a ""routine treatment"" control. Two high-secure, sub-acute wards in the Long Bay Hospital Mental Health Unit will be non-randomly allocated to either the exergaming intervention or the ""routine treatment"" control group. The intervention group will receive a 12-week programme comprising three 30-min exergaming sessions per week using various Xbox Kinect TM  activity-based games designed to simulate moderate intensity exercise. The ""routine treatment"" group will continue to receive the standard model of care delivered by the Justice Health and Forensic Mental Health Network. Accelerometers will be distributed to all participants to collect daily energy expenditure, number of steps taken, intensity of physical activity and heart rate data throughout the study. The primary outcomes are (1) intervention feasibility and acceptability, and (2) baseline to post-intervention changes in physical health outcomes (levels of physical activity; cardiovascular fitness; clinical measures of cardiometabolic risk). Secondary outcomes are baseline to post-intervention changes in mental health outcomes (depression, anxiety, stress, positive psychiatric symptoms). Outcomes will be assessed at baseline, mid-intervention, and post-intervention.
DISCUSSION


This research will contribute to evidence-based practice in the care of patients with serious mental illness: a vulnerable population with complex physical and mental health needs and a markedly elevated risk of cardiovascular disease. The findings will inform cardiovascular health promotion strategies and the implementation of physical activity interventions in secure inpatient settings.
TRIAL REGISTRATION


ANZCTR, ACTRN12619000202167. Registered on 12 February 2019, https://www.anzctr.org.au . ANZCTR mandatory data items comply with the minimum dataset requirements of the World Health Organisation (WHO). The ANZCTR contributes trial registration data to the WHO International Clinical Trials Registry Platform (WHO ICTRP).",2022,"This study aims to investigate the feasibility, acceptability and potential effectiveness of an intervention (exergaming) to promote physical activity among patients in a secure mental health setting.
","['patients in a secure mental health setting', 'Two high-secure, sub-acute wards in the Long Bay Hospital Mental Health Unit', 'patients with serious mental illness']","['Xbox Kinect TM  activity-based games designed to simulate moderate intensity exercise', 'exergaming intervention with a ""routine treatment"" control', 'intervention (exergaming']","['baseline to post-intervention changes in mental health outcomes (depression, anxiety, stress, positive psychiatric symptoms', 'feasibility, acceptability and potential effectiveness', 'intervention feasibility and acceptability, and (2) baseline to post-intervention changes in physical health outcomes (levels of physical activity; cardiovascular fitness; clinical measures of cardiometabolic risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0333739,"This study aims to investigate the feasibility, acceptability and potential effectiveness of an intervention (exergaming) to promote physical activity among patients in a secure mental health setting.
","[{'ForeName': 'Sharlene', 'Initials': 'S', 'LastName': 'Kaye', 'Affiliation': 'Research Unit, Justice Health and Forensic Mental Health Network, Long Bay Complex, Roundhouse, 1300 Anzac Parade, Malabar, NSW, 2036, Australia. Sharlene.Goodhew@health.nsw.gov.au.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lewandowski', 'Affiliation': 'Research Unit, Justice Health and Forensic Mental Health Network, Long Bay Complex, Roundhouse, 1300 Anzac Parade, Malabar, NSW, 2036, Australia.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Dunne', 'Affiliation': 'Research Unit, Justice Health and Forensic Mental Health Network, Long Bay Complex, Roundhouse, 1300 Anzac Parade, Malabar, NSW, 2036, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bowman', 'Affiliation': 'Research Unit, Justice Health and Forensic Mental Health Network, Long Bay Complex, Roundhouse, 1300 Anzac Parade, Malabar, NSW, 2036, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Archer', 'Affiliation': 'Research Unit, Justice Health and Forensic Mental Health Network, Long Bay Complex, Roundhouse, 1300 Anzac Parade, Malabar, NSW, 2036, Australia.'}]",Pilot and feasibility studies,['10.1186/s40814-022-01068-2']
1700,35690844,Correction: Effects of spermidine supplementation on cognition and biomarkers in older adults with subjective cognitive decline (SmartAge)-study protocol for a randomized controlled trial.,,2022,,['older adults with subjective cognitive decline (SmartAge)-study protocol'],['spermidine supplementation'],['cognition and biomarkers'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0037871', 'cui_str': 'spermidine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.30298,,"[{'ForeName': 'Miranka', 'Initials': 'M', 'LastName': 'Wirth', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik und Hochschulambulanz für Neurologie, Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schwarz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik und Hochschulambulanz für Neurologie, Berlin, Germany.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Benson', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik und Hochschulambulanz für Neurologie, Berlin, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Horn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik und Hochschulambulanz für Neurologie, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Buchert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Nuclear Medicine, Berlin, Germany.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Lange', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Nuclear Medicine, Berlin, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Köbe', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik und Hochschulambulanz für Neurologie, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hetzer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin Center for Advanced Neuroimaging, Berlin, Germany.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Maglione', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Clinical Research Center, Berlin, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Michael', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Clinical Research Center, Berlin, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Märschenz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Clinical Research Center, Berlin, Germany.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology & Metabolism, Berlin, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Kopp', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik und Hochschulambulanz für Neurologie, Berlin, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Schmitz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Clinical Research Center, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Grittner', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Biometry and Clinical Epidemiology, Berlin, Germany.'}, {'ForeName': 'Stephan J', 'Initials': 'SJ', 'LastName': 'Sigrist', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Clinical Research Center, Berlin, Germany.'}, {'ForeName': 'Slaven', 'Initials': 'S', 'LastName': 'Stekovic', 'Affiliation': 'Institute of Molecular Biosciences, University of Graz, NAWI Graz, Graz, Austria.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Madeo', 'Affiliation': 'Institute of Molecular Biosciences, University of Graz, NAWI Graz, Graz, Austria. frank.madeo@uni-graz.at.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Flöel', 'Affiliation': 'Department of Neurology, University Medicine Greifswald, Greifswald, Germany. agnes.floeel@uni-greifswald.de.'}]",Alzheimer's research & therapy,['10.1186/s13195-022-01012-9']
1701,35690817,Is letrozole during ovarian stimulation useful in breast cancer patients undergoing fertility preservation to reduce early luteal progesterone levels following GnRH-agonist trigger?,"BACKGROUND


In absence of contraindication, breast cancer patients of reproductive age can undergo fertility preservation with controlled ovarian stimulation for oocyte/embryo cryopreservation before the administration of potentially gonadotoxic treatments. High hormonal levels induced by ovarian stimulation might have an adverse impact on hormone-positive breast cancer. Whether letrozole supplementation during ovarian stimulation (COSTLES) reduces serum progesterone levels after GnRHa trigger remains unknown. We aimed to determine whether COSTLES might be useful for breast cancer patients undergoing fertility preservation to reduce early luteal progesterone levels following GnRH-agonist (GnRHa)trigger.
METHODS


All women who underwent COS with GnRH antagonist protocol with GnRHa trigger were included. Serum progesterone level measured 12 h after GnRHa trigger was compared between patients undergoing COS with letrozole supplementation (COSTLES group) and patients undergoing COS without letrozole (Control group) for fertility preservation purposes.
RESULTS


A total of 246 patients were included, of which 84 patients (34.1%) in the COSTLES group and 162 patients (65.6%) in the Control group. All patients in the COSTLES group were BC patients (n = 84, 100%), while the Control group included 77 BC patients (47.5%). Patients in the two groups were comparable. The mean number of oocytes recovered and vitrified at metaphase 2 stage did not significantly differ between the two groups. Serum progesterone levels on the day after GnRHa trigger were significantly lower in the COSTLES group (8.6 ± 0.7 vs. 10.5 ± 0.5 ng/mL, respectively, p < 0.03), as well as serum E2 levels (650.3 ± 57.7 vs. 2451.4.0 ± 144.0 pg/mL, respectively, p < 0.01). However, the GnRHa-induced LH surge was significantly higher in in the COSTLES group (71.9 ± 4.6 vs. 51.2 ± 2.6 UI/L, respectively, p < 0.01).
CONCLUSIONS


Our results show that COSTLES for fertility preservation in breast cancer patients using GnRHa trigger reduces serum progesterone levels compared to ovarian stimulation without letrozole. These findings encourage the use of COSTLES in this context to decrease the potential deleterious effect of elevated hormonal levels on hormone-positive breast cancer.",2022,The mean number of oocytes recovered and vitrified at metaphase 2 stage did not significantly differ between the two groups.,"['246 patients were included, of which 84 patients (34.1%) in the COSTLES group and 162 patients (65.6%) in the Control group', 'breast cancer patients', 'breast cancer patients of reproductive age', 'breast cancer patients undergoing fertility preservation to reduce early luteal progesterone levels following GnRH-agonist (GnRHa)trigger.\nMETHODS\n\n\nAll women who underwent COS with GnRH antagonist protocol with GnRHa trigger were included', 'breast cancer patients undergoing fertility preservation']","['letrozole supplementation', 'COS without letrozole', 'letrozole']","['mean number of oocytes recovered and vitrified at metaphase 2 stage', 'early luteal progesterone levels', 'serum progesterone levels', 'serum E2 levels', 'Serum progesterone level', 'Serum progesterone levels', 'GnRHa-induced LH surge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1171194', 'cui_str': 'Fertility care'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454802', 'cui_str': 'Cos'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0454802', 'cui_str': 'Cos'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",246.0,0.12512,The mean number of oocytes recovered and vitrified at metaphase 2 stage did not significantly differ between the two groups.,"[{'ForeName': 'Imane', 'Initials': 'I', 'LastName': 'Lalami', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Labrosse', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Cedrin-Durnerin', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Comtet', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vinolas', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Krief', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sifer', 'Affiliation': 'Department of Cytogenetic and Reproductive Biology, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Maeliss', 'Initials': 'M', 'LastName': 'Peigne', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grynberg', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France. michael.grynberg@aphp.fr.'}]",Reproductive biology and endocrinology : RB&E,['10.1186/s12958-022-00958-7']
1702,35691208,Effects of cognitive behavioral therapy for insomnia on subjective and objective measures of sleep and cognition.,"STUDY OBJECTIVES


To assess the effects of Cognitive Behavioral Therapy for insomnia (CBTi) on subjective and objective measures of sleep, sleep-state misperception and cognitive performance.
METHODS


We performed a randomized-controlled trial with a treatment group and a wait-list control group to assess changes in insomnia symptoms after CBTi (8 weekly group sessions/3 months) in 62 participants with chronic insomnia. To this end, we conducted a multimodal investigation of sleep and cognition including subjective measures of sleep difficulties (Insomnia Severity Index [ISI]; sleep diaries) and cognitive functioning (Sahlgrenska Academy Self-reported Cognitive Impairment Questionnaire), objective assessments of sleep (polysomnography recording), cognition (attention and working memory tasks), and sleep-state misperception measures, collected at baseline and at 3-months post-randomization. We also assessed ISI one year after CBTi. Our main analysis investigated changes in sleep and cognition after 3 months (treatment versus wait-list).
RESULTS


While insomnia severity decreased and self-reported sleep satisfaction improved after CBTi, we did not find any significant change in objective and subjective sleep measures (e.g., latency, duration). Degree of discrepancy between subjective and objective sleep (i.e., sleep misperception) in sleep latency and sleep duration decreased after CBTi suggesting a better perception of sleep after CBTi. In contrast, both objective and subjective cognitive functioning did not improve after CBTi.
CONCLUSIONS


We showed that group-CBTi has a beneficial effect on variables pertaining to the subjective perception of sleep, which is a central feature of insomnia. However, we observed no effect of CBTi on measures of cognitive functioning.",2022,"RESULTS


While insomnia severity decreased and self-reported sleep satisfaction improved after CBTi, we did not find any significant change in objective and subjective sleep measures (e.g., latency, duration).",['62 participants with chronic insomnia'],"['Cognitive Behavioral Therapy', 'CBTi', 'cognitive behavioral therapy']","['insomnia symptoms', 'cognitive functioning', 'sleep difficulties (Insomnia Severity Index [ISI]; sleep diaries) and cognitive functioning (Sahlgrenska Academy Self-reported Cognitive Impairment Questionnaire), objective assessments of sleep (polysomnography recording), cognition (attention and working memory tasks), and sleep-state misperception measures', 'sleep satisfaction', 'sleep and cognition', 'subjective and objective measures of sleep and cognition', 'objective and subjective sleep measures (e.g., latency, duration', 'objective and subjective cognitive functioning', 'sleep latency and sleep duration']","[{'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0752286', 'cui_str': 'Sleep state misperception'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]",62.0,0.0298848,"RESULTS


While insomnia severity decreased and self-reported sleep satisfaction improved after CBTi, we did not find any significant change in objective and subjective sleep measures (e.g., latency, duration).","[{'ForeName': 'Aurore A', 'Initials': 'AA', 'LastName': 'Perrault', 'Affiliation': ""Sleep, Cognition and Neuroimaging Lab, Department of Health, Kinesiology and Applied Physiology & Center for Studies in Behavioral Neurobiology, Concordia University, Montreal, Quebec, Canada; Centre de Recherche de L'Institut Universitaire de Gériatrie de Montréal, CIUSSS Centre-Sud-de-l'Ile-de-Montréal, Québec, Canada. Electronic address: aurore.perrault@gmail.com.""}, {'ForeName': 'Florence B', 'Initials': 'FB', 'LastName': 'Pomares', 'Affiliation': ""Sleep, Cognition and Neuroimaging Lab, Department of Health, Kinesiology and Applied Physiology & Center for Studies in Behavioral Neurobiology, Concordia University, Montreal, Quebec, Canada; Centre de Recherche de L'Institut Universitaire de Gériatrie de Montréal, CIUSSS Centre-Sud-de-l'Ile-de-Montréal, Québec, Canada; Stress, Interpersonal Relationship and Health Lab, Department of Psychology & Centre for Clinical Research in Health, Concordia University, Montreal, Quebec, Canada.""}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Sleep, Cognition and Neuroimaging Lab, Department of Health, Kinesiology and Applied Physiology & Center for Studies in Behavioral Neurobiology, Concordia University, Montreal, Quebec, Canada; Sleep Unit, University of Ottawa Institute for Mental Health Research, Ottawa, Ontario, Canada.'}, {'ForeName': 'Nathan E', 'Initials': 'NE', 'LastName': 'Cross', 'Affiliation': ""Sleep, Cognition and Neuroimaging Lab, Department of Health, Kinesiology and Applied Physiology & Center for Studies in Behavioral Neurobiology, Concordia University, Montreal, Quebec, Canada; Centre de Recherche de L'Institut Universitaire de Gériatrie de Montréal, CIUSSS Centre-Sud-de-l'Ile-de-Montréal, Québec, Canada.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gong', 'Affiliation': 'Sleep, Cognition and Neuroimaging Lab, Department of Health, Kinesiology and Applied Physiology & Center for Studies in Behavioral Neurobiology, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Maltezos', 'Affiliation': 'Sleep, Cognition and Neuroimaging Lab, Department of Health, Kinesiology and Applied Physiology & Center for Studies in Behavioral Neurobiology, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': 'Sleep, Cognition and Neuroimaging Lab, Department of Health, Kinesiology and Applied Physiology & Center for Studies in Behavioral Neurobiology, Concordia University, Montreal, Quebec, Canada; Stress, Interpersonal Relationship and Health Lab, Department of Psychology & Centre for Clinical Research in Health, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Madigan', 'Affiliation': 'Stress, Interpersonal Relationship and Health Lab, Department of Psychology & Centre for Clinical Research in Health, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Lukia', 'Initials': 'L', 'LastName': 'Tarelli', 'Affiliation': ""Sleep, Cognition and Neuroimaging Lab, Department of Health, Kinesiology and Applied Physiology & Center for Studies in Behavioral Neurobiology, Concordia University, Montreal, Quebec, Canada; Centre de Recherche de L'Institut Universitaire de Gériatrie de Montréal, CIUSSS Centre-Sud-de-l'Ile-de-Montréal, Québec, Canada; Stress, Interpersonal Relationship and Health Lab, Department of Psychology & Centre for Clinical Research in Health, Concordia University, Montreal, Quebec, Canada.""}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'McGrath', 'Affiliation': 'Pediatric Public Health Psychology Laboratory, Department of Psychology & Centre for Clinical Research in Health, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Josée', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'School of Psychology, Université Laval and CHU de Québec-Université Laval Research Center, Québec, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine and Swiss Center for Affective Sciences, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Gouin', 'Affiliation': ""Centre de Recherche de L'Institut Universitaire de Gériatrie de Montréal, CIUSSS Centre-Sud-de-l'Ile-de-Montréal, Québec, Canada; Stress, Interpersonal Relationship and Health Lab, Department of Psychology & Centre for Clinical Research in Health, Concordia University, Montreal, Quebec, Canada; PERFORM Center, Concordia University, Montreal, Quebec, Canada.""}, {'ForeName': 'Thien Thanh', 'Initials': 'TT', 'LastName': 'Dang-Vu', 'Affiliation': ""Sleep, Cognition and Neuroimaging Lab, Department of Health, Kinesiology and Applied Physiology & Center for Studies in Behavioral Neurobiology, Concordia University, Montreal, Quebec, Canada; Centre de Recherche de L'Institut Universitaire de Gériatrie de Montréal, CIUSSS Centre-Sud-de-l'Ile-de-Montréal, Québec, Canada; PERFORM Center, Concordia University, Montreal, Quebec, Canada. Electronic address: tt.dangvu@concordia.ca.""}]",Sleep medicine,['10.1016/j.sleep.2022.05.010']
1703,35691184,Transcranial magnetic stimulation versus transcutaneous neuromuscular electrical stimulation in post stroke dysphagia: A clinical randomized controlled trial.,"OBJECTIVES


To evaluate the efficacy of high-frequency repeated transcranial magnetic stimulation (rTMS) applied contralesionally versus transcutaneous neuromuscular electrical stimulation (TNES) in acute post-stroke dysphagic patients.
MATERIALS AND METHODS


A randomized, parallel, comparative, controlled trial was conducted on patients with acute ischemic stroke who were admitted to our department. Fifteen patients received rTMS, 15 patients received TNES, and 15 patients were recruited as a control group. Between the second and tenth days after a stroke, patients were enrolled. The study and follow-up periods were completed by all patients.
RESULTS


Among the screened patients, 45 (31.47%) right-handed patients were diagnosed with post-stroke dysphagia with a mean age of 60.53 ± 8.23 years. Immediately after intervention both rTMS and TNES groups significantly improve the swallowing disturbance questionnaire (SDQ) and penetration aspiration scale (PAS), compared to the control (p < 0.001 and p = 0.027), respectively. rTMS was more effective than TNES in reducing SDQ and PAS (p < 0.05). rTMS and TNES improved the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS) significantly (p = 0.002); however, their efficacy was comparable (p > 0.05). A significant (p < 0.001) strong negative correlation was observed between the grade of weakness and all scores.
CONCLUSION


Our findings showed that high-frequency rTMS and TNES effectively improved the clinical condition of acute post-stroke dysphagic patients in terms of swallowing disturbance assessed by SDQ, pharyngeal residue assessed by YPRSRS, and the severity of penetration and aspiration events evaluated by PAS, compared to the controls. The outcomes of high-frequency rTMS were more favorable than those of TNES in terms of SDQ and PAS.",2022,"Immediately after intervention both rTMS and TNES groups significantly improve the swallowing disturbance questionnaire (SDQ) and penetration aspiration scale (PAS), compared to the control (p < 0.001 and p = 0.027), respectively.","[' and 15 patients were recruited as a control group', 'patients with acute ischemic stroke who were admitted to our department', 'screened patients, 45 (31.47%) right-handed patients were diagnosed with post-stroke dysphagia with a mean age of 60.53\xa0±\xa08.23 years', 'post stroke dysphagia', 'acute post-stroke dysphagic patients']","['Transcranial magnetic stimulation versus transcutaneous neuromuscular electrical stimulation', 'TNES', 'rTMS', 'rTMS and TNES', 'high-frequency repeated transcranial magnetic stimulation (rTMS) applied contralesionally versus transcutaneous neuromuscular electrical stimulation (TNES']","['SDQ and PAS', 'swallowing disturbance questionnaire (SDQ) and penetration aspiration scale (PAS', 'Yale Pharyngeal Residue Severity Rating Scale (YPRSRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0121489,"Immediately after intervention both rTMS and TNES groups significantly improve the swallowing disturbance questionnaire (SDQ) and penetration aspiration scale (PAS), compared to the control (p < 0.001 and p = 0.027), respectively.","[{'ForeName': 'Azza B', 'Initials': 'AB', 'LastName': 'Hammad', 'Affiliation': 'Department of Neurology, Al-Zahraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Elhamrawy', 'Affiliation': 'Department of Neurology, Al-Zahraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hayam', 'Initials': 'H', 'LastName': 'Abdel-Tawab', 'Affiliation': 'Department of Neurology, Al-Zahraa University Hospital, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Shafik', 'Affiliation': 'Neurology Department, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yossra', 'Initials': 'Y', 'LastName': 'Sallam', 'Affiliation': 'Phoniatrics, Otorhinolaryngology Department, Al-Zahraa University Hospital, Faculty of Medicine for Girls, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hala Mohamed', 'Initials': 'HM', 'LastName': 'Elzomor', 'Affiliation': 'Rheumatology and Rehabilitation Department, Al-Zahraa University Hospital, Faculty of Medicine for Girls, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Eshak I', 'Initials': 'EI', 'LastName': 'Bahbah', 'Affiliation': 'Faculty of Medicine, Al-Azhar University, Damietta 34511, Egypt. Electronic address: Isaacbahbah@domazhermedicine.edu.eg.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2022.106554']
1704,35691183,"Applied nutritional investigationEffects of acute arginine supplementation on neuroendocrine, metabolic, cardiovascular, and mood outcomes in younger men: A double-blind, placebo-controlled trial.","OBJECTIVES


Arginine is an amino-acid supplement and precursor for nitric-oxide synthesis, which affects various biologic processes. The objective of this study was to determine the effects of arginine supplementation on growth hormone (GH) and metabolic parameters.
METHODS


Thirty physically active, healthy men (age 18-39 y; body mass index: 18.5-25 kg/m 2 ) were randomized in a double-blind, placebo-controlled, crossover trial. Arginine (10 g) and placebo (0 g) beverages were consumed after an overnight fast. Blood samples were collected at baseline and 1.5, 3.0, and 24 h after supplementation. The primary outcomes were serum GH and metabolomics. Also, amino acids, glucose, insulin, triacylglycerols, thyroid hormones, testosterone, cortisol, dehydroepiandrosterone, and mood state were assessed. Individuals with detectable increases in GH were analyzed separately (responders: n = 16; < 0.05 ng/mL at 1.5 h). Repeated-measure analyses of variance estimated the treatment effects at each timepoint.
RESULTS


Arginine levels increased at 1.5 h (146%) and 3.0 h (95%; P ≤ 0.001) and GH (193%) and thyroid-stimulating hormone (TSH; 10%) levels at 24 h (P < 0.05) after arginine versus placebo consumption. Arginine versus placebo increased glucose levels at 1.5 h (5%) and 3.0 h (3%; P ≤ 0.001). Arginine versus placebo did not affect other dependent measures, including mood state (P > 0.05), but changes in the urea, glutamate, and citric-acid pathways were observed. Among responders, arginine versus placebo increased GH at 1.5 h (37%), glucose at 1.5 h (4%) and 3.0 h (4%), and TSH at 24 h (9%; P < 0.05). Responders had higher levels of benzoate metabolites at baseline and 1.5 h, and an unknown compound (X-16124) at baseline, 1.5 h, and 24 h that corresponds to a class of gut microbes (P < 0.05).
CONCLUSIONS


Arginine supplementation modestly increased GH, glucose, and TSH levels in younger men. Responders had higher benzoate metabolites and an unknown analyte attributed to the gut microbiome. Future studies should examine whether the increased prevalence of these gut microorganisms corresponds with GH response after arginine supplementation.",2022,"Among responders, arginine versus placebo increased GH at 1.5 h (37%), glucose at 1.5 h (4%) and 3.0 h (4%), and TSH at 24 h (9%; P < 0.05).","['younger men', 'Thirty physically active, healthy men (age 18-39 y; body mass index: 18.5-25 kg/m 2 ']","['Arginine supplementation', 'arginine versus placebo', 'arginine supplementation', 'Arginine (10 g) and placebo', 'Arginine versus placebo', 'placebo']","['Arginine levels', 'GH', 'growth hormone (GH) and metabolic parameters', 'neuroendocrine, metabolic, cardiovascular, and mood outcomes', 'Blood samples', 'serum GH and metabolomics', 'mood state', 'benzoate metabolites', 'GH, glucose, and TSH levels', 'glucose levels', 'urea, glutamate, and citric-acid pathways', 'amino acids, glucose, insulin, triacylglycerols, thyroid hormones, testosterone, cortisol, dehydroepiandrosterone, and mood state']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1318182', 'cui_str': '10G'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0428401', 'cui_str': 'Serum growth hormone measurement'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005058', 'cui_str': 'Benzoates'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}]",30.0,0.727498,"Among responders, arginine versus placebo increased GH at 1.5 h (37%), glucose at 1.5 h (4%) and 3.0 h (4%), and TSH at 24 h (9%; P < 0.05).","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana. Electronic address: John.Apolzan@pbrc.edu.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Stein', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, Massachusetts; Oak Ridge Institute for Science and Education, Oak Ridge, Tennessee.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana.'}, {'ForeName': 'Shengping', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana.'}, {'ForeName': 'Harris R', 'Initials': 'HR', 'LastName': 'Lieberman', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2022.111658']
1705,35691791,The safety of neoadjuvant hormonal treatment in infants with cryptorchidism.,"BACKGROUND/PURPOSE


The standard treatment for boys with non-syndromic cryptorchidism is an early orchidopexy. It is unclear if surgical intervention alone is enough for future fertility. Recent studies show benefit of neoadjuvant or adjuvant hormonal treatment with gonadorelin (GnRH) for spermatogonia maturation based on testicular biopsy. The aim of this prospective study was to assess the safety of this treatment in infants with undescended testis at the recommended timing of early gonadorelin administration and timing of orchidopexy.
METHODS


Unilateral cryptorchid full term boys were initially examined (including hormonal, physical and ultrasound examination) at the age of 2.5-3.5 months. At 6 months of age, cryptorchidism was confirmed. Those with non-syndromic cryptorchidism and palpable or sonographically detected testis were randomly assigned into two groups: with and without intranasal gonadorelin treatment. Inclusion criteria were met by 36 boys (21 in GNRH and 15 in the control groups). The following orchidopexy was performed before 12 months of age with repeated examination at time of surgery. Penile size and testicular volume (using ultrasound) and basal serum levels of LH, FSH, testosterone, Inhibin B and AMH were recorded at age of 3.0 (mean) months and 11.0 (mean) months (date of surgery). The stimulation hormonal levels were checked during GnRH administration.
RESULTS


Between minipuberty (mean 3 months) and time of orchidopexy (mean 11 months of age) the penile size increased significantly and similarly in both groups. There was no significant difference in the change of the volume of descended testis between the groups nor of the volume of undescended testis. In addition, we did not find any significant difference in the change (drop) of hormonal levels of LH, FSH, Testosterone, Inhibin B and AMH (Table 1a) CONCLUSION: The neoadjuvant gonadorelin stimulation in infants with unilateral undescended testis has not shown any specific effect on the development of penile size, testicular volume and hormonal levels at time of orchidopexy in comparison with boys without stimulation, and in the mid-term, this treatment can be considered safe. Further follow-up is necessary to evaluate the long-term effect of this early treatment.",2022,There was no significant difference in the change of the volume of descended testis between the groups nor of the volume of undescended testis.,"['infants with unilateral undescended testis', 'infants with cryptorchidism', 'Those with non-syndromic cryptorchidism and palpable or sonographically detected testis', 'Unilateral cryptorchid full term boys were initially examined (including hormonal, physical and ultrasound examination) at the age of 2.5-3.5 months', 'Inclusion criteria were met by 36 boys (21 in GNRH and 15 in the control groups', 'infants with undescended testis at the recommended timing of early gonadorelin administration and timing of orchidopexy', 'boys with non-syndromic cryptorchidism is an early orchidopexy']","['neoadjuvant or adjuvant hormonal treatment with gonadorelin (GnRH', 'neoadjuvant hormonal treatment', 'intranasal gonadorelin treatment']","['Penile size and testicular volume (using ultrasound) and basal serum levels of LH, FSH, testosterone, Inhibin B and AMH', 'penile size', 'time of orchidopexy', 'volume of undescended testis', 'hormonal levels of LH, FSH, Testosterone, Inhibin B and AMH', 'stimulation hormonal levels', 'change of the volume of descended testis']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0431664', 'cui_str': 'Unilateral undescended testis'}, {'cui': 'C0010417', 'cui_str': 'Undescended testicle'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0021358', 'cui_str': 'Structure of inferior colliculus of corpora quadrigemina'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0194907', 'cui_str': 'Orchidopexy'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0429619', 'cui_str': 'Testicular volume'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0971174', 'cui_str': 'Inhibin B'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0194907', 'cui_str': 'Orchidopexy'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0010417', 'cui_str': 'Undescended testicle'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0021358', 'cui_str': 'Structure of inferior colliculus of corpora quadrigemina'}]",,0.0491033,There was no significant difference in the change of the volume of descended testis between the groups nor of the volume of undescended testis.,"[{'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Fiala', 'Affiliation': 'Department of Urology, General University Hospital and 1st. Faculty of Medicine of Charles University in Prague, Czech Republic. Electronic address: vojtech.fiala@vfn.cz.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Jiraskova', 'Affiliation': 'Department of Urology, General University Hospital and 1st. Faculty of Medicine of Charles University in Prague, Czech Republic. Electronic address: valova.z@gmail.com.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Drlik', 'Affiliation': 'Department of Urology, General University Hospital and 1st. Faculty of Medicine of Charles University in Prague, Czech Republic. Electronic address: marcel.drlik@vfn.cz.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Sedlacek', 'Affiliation': 'Department of Urology, General University Hospital and 1st. Faculty of Medicine of Charles University in Prague, Czech Republic. Electronic address: josef.sedlacek@vfn.cz.'}, {'ForeName': 'Zdenek', 'Initials': 'Z', 'LastName': 'Dite', 'Affiliation': 'Department of Urology, General University Hospital and 1st. Faculty of Medicine of Charles University in Prague, Czech Republic. Electronic address: zdenek.dite@vfn.cz.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Novakova', 'Affiliation': 'Department of Urology, General University Hospital and 1st. Faculty of Medicine of Charles University in Prague, Czech Republic. Electronic address: petra.novakova2@vfn.cz.'}, {'ForeName': 'Radim', 'Initials': 'R', 'LastName': 'Kocvara', 'Affiliation': 'Department of Urology, General University Hospital and 1st. Faculty of Medicine of Charles University in Prague, Czech Republic. Electronic address: radim.kocvara@vfn.cz.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kalousova', 'Affiliation': 'Institute of Medical Biochemistry and Laboratory Diagnostics, General University Hospital and 1st. Faculty of Medicine of Charles University in Prague, Czech Republic. Electronic address: marta.kalousova@lf1.cuni.cz.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Soukup', 'Affiliation': 'Department of Urology, General University Hospital and 1st. Faculty of Medicine of Charles University in Prague, Czech Republic. Electronic address: viktor.soukup@vfn.cz.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2022.05.010']
1706,35691777,A protocol for a randomized trial measuring flowmetry in risk areas for pressure ulcer: Hyperoxygenated fatty acids vs olive oil.,"BACKGROUND


Pressure ulcers are a common adverse event in healthcare. To date, no flowmetry studies have been conducted to compare hyperoxygenated fatty acids (HFA) vs. extra-virgin olive oil (EVOO) in alleviating this condition.
AIMS


To determine and evaluate the effect of the application of HFA vs. EVOO on tissue oxygenation and perfusion in heels under pressure, in healthy persons and in hospitalised patients.
DESIGN


Two-phase experimental study.
METHODS


Phase 1 will be conducted with healthy subjects, using a randomised, open study design, evaluating an intrasubject control group. Phase 2 will focus on hospitalised subjects, with a randomised, open study group vs. a control group.
DISCUSSION


This Project is undertaken to identify the mechanisms that intervene in the genesis of pressure ulcers and to determine whether there are differences in outcomes between the application of HFA vs. EVOO as a preventive measure The results of this study are of economic importance (due to the price difference between the products used) and will also impact on usual clinical practice for patients with impaired mobility and liable to suffer from pressure ulcers, by considering an alternative to established preventive measures.",2022,"To determine and evaluate the effect of the application of HFA vs. EVOO on tissue oxygenation and perfusion in heels under pressure, in healthy persons and in hospitalised patients.
","['healthy subjects', 'hospitalised subjects', 'risk areas for pressure ulcer', 'patients with impaired mobility and liable to suffer from pressure ulcers', 'healthy persons and in hospitalised patients']","['HFA vs. EVOO', 'hyperoxygenated fatty acids (HFA) vs. extra-virgin olive oil (EVOO', 'Hyperoxygenated fatty acids vs olive oil']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518456', 'cui_str': 'Impaired mobility'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]",[],,0.044284,"To determine and evaluate the effect of the application of HFA vs. EVOO on tissue oxygenation and perfusion in heels under pressure, in healthy persons and in hospitalised patients.
","[{'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Lupiáñez-Pérez', 'Affiliation': 'University of Málaga, Faculty of Health Sciences, Department of Nursing, Spain; Servicio Andaluz de Salud (SAS), Distrito Sanitario Málaga, Valle del Guadalhorce, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA, Spain.'}, {'ForeName': 'Alberto José', 'Initials': 'AJ', 'LastName': 'Gómez-González', 'Affiliation': 'University of Málaga, Faculty of Health Sciences, Department of Nursing, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Morilla-Herrera', 'Affiliation': 'University of Málaga, Faculty of Health Sciences, Department of Nursing, Spain; Servicio Andaluz de Salud (SAS), Distrito Sanitario Málaga, Valle del Guadalhorce, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Marfil-Gómez', 'Affiliation': 'University of Málaga, Faculty of Health Sciences, Department of Nursing, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'León-Campos', 'Affiliation': 'University of Málaga, Faculty of Health Sciences, Department of Nursing, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA, Spain. Electronic address: alvaroleon@uma.es.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Caro-Bautista', 'Affiliation': 'University of Málaga, Faculty of Health Sciences, Department of Nursing, Spain; Servicio Andaluz de Salud (SAS), Distrito Sanitario Málaga, Valle del Guadalhorce, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Villa-Estrada', 'Affiliation': 'University of Málaga, Faculty of Health Sciences, Department of Nursing, Spain; Servicio Andaluz de Salud (SAS), Distrito Sanitario Málaga, Valle del Guadalhorce, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Aranda-Gallardo', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA, Spain; Agencia Sanitaria Costa del Sol. Marbella, Spain.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Moya-Suárez', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA, Spain; Agencia Sanitaria Costa del Sol. Marbella, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Morales-Asencio', 'Affiliation': 'University of Málaga, Faculty of Health Sciences, Department of Nursing, Spain; Instituto de Investigación Biomédica de Málaga (IBIMA, Spain.'}]",Journal of tissue viability,['10.1016/j.jtv.2022.05.008']
1707,35692074,Bronchial thermoplasty: State of the art.,"Since the publication of a sham-controlled, randomized trial (AIR2) and subsequent marketing approval by the US Food and Drug Administration, we have significantly advanced our understanding of bronchial thermoplasty (BT)'s scientific basis, long-term safety, clinical efficacy and cost-effectiveness. In particular, the last 2 years have witnessed multiple research publications on several of these counts. In this review, we critically appraise our evolving understanding of BT's biologic underpinnings and clinical impact, offer an evidence-based patient workflow guide for the busy pulmonologist and highlight both current challenges as well as potential solutions for the researcher and the clinician.",2022,"Since the publication of a sham-controlled, randomized trial (AIR2) and subsequent marketing approval by the US Food and Drug Administration, we have significantly advanced our understanding of bronchial thermoplasty (BT)'s scientific basis, long-term safety, clinical efficacy and cost-effectiveness.",[],[],[],[],[],[],,0.130982,"Since the publication of a sham-controlled, randomized trial (AIR2) and subsequent marketing approval by the US Food and Drug Administration, we have significantly advanced our understanding of bronchial thermoplasty (BT)'s scientific basis, long-term safety, clinical efficacy and cost-effectiveness.","[{'ForeName': 'Muhammad Daniyal', 'Initials': 'MD', 'LastName': 'Hashmi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Henry Ford Hospital, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Massachusetts Chan Medical School-Baystate, Springfield, Massachusetts, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Shafiq', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}]","Respirology (Carlton, Vic.)",['10.1111/resp.14312']
1708,35692065,[Effect and mechanism of glucocorticoids in preventing stenosis after esophageal endoscopic submucosal dissection].,"Objective:  To explore the role and specific mechanism of glucocorticoids in preventing stenosis after esophageal endoscopic submucosal dissection (ESD).  Methods:  Data of 81 patients [51 cases were male and 30 cases were female, aged (62.09±7.95) years] undergoing early esophageal cancer or precancerous lesions with a stripping range ≥3/4 circle hospitalized from January 2019 to February 2021 in Department of Gastroenterology, Zhongda Hospital, Southeast University. They were randomly divided into the control group ( n =23), oral prednisone acetate group ( n =28) and/or combined with local injection Triamcinolone acetonide group ( n =30). Analysis the stenosis rates, endoscopic stent dilatation times, the scores of the Atkinson classification and QLQ-OES18 after 12 weeks. Also the expression of carbohydrate sulfotransferase15 (CHST15) mRNA, TGF-β1 and Collagen-Ⅰ protein were compared by real-time PCR or immunohistochemistry.  Results:  The stenosis rates of the control group, oral prednisone acetate group and/or combined with local injection Triamcinolone acetonide group were 82.6% (19/23), 46.4% (13/28) and 20.0% (6/30) ( P <0.001); endoscopic stent dilatation times [ M  ( Q 1 , Q 3 )] in these three groups were 2 (1, 3), 0 (0, 0) and 0 (0, 0) ( P <0.001). After ESD, the scores of the Atkinson classification and QLQ-OES18 in the three groups were lower than before ( P <0.001); and the expression of CHST15 mRNA in the three groups were 4.31±0.13, 3.44±0.07 and 2.84±0.21 respectively ( P <0.001). Compared with the control group, the expression of CHST15 mRNA in oral prednisone acetate group was down-regulated ( P <0.001), and was the lowest in oral prednisone acetate combined with local injection Triamcinolone acetonide group ( P <0.001). As CHST15 mRNA was down-regulated, the expression of TGF-β1 and Collagen-I protein was also down-regulated ( P <0.05).  Conclusions:  Oral prednisone alone or combined with local injection of triamcinolone acetonide both can prevent esophageal stenosis effectively. Oral combined with local injection of glucocorticoid is particularly more effective. Glucocorticoid can reduce the expression of CHST15 mRNA, thereby inhibiting the expression of TGF-β1 and Collagen-I protein.",2022,"Compared with the control group, the expression of CHST15 mRNA in oral prednisone acetate group was down-regulated ( P <0.001), and was the lowest in oral prednisone acetate combined with local injection Triamcinolone acetonide group ( P <0.001).","['group ( n =28', '51 cases were male and 30 cases were female, aged (62.09±7.95) years] undergoing early esophageal cancer or precancerous lesions with a stripping range ≥3/4 circle hospitalized from January 2019 to February 2021 in Department of Gastroenterology, Zhongda Hospital, Southeast University', 'stenosis after esophageal endoscopic submucosal dissection', 'stenosis after esophageal endoscopic submucosal dissection (ESD', '81 patients ']","['local injection Triamcinolone acetonide', 'prednisone acetate group', 'glucocorticoid', 'Triamcinolone acetonide', 'oral prednisone acetate', 'glucocorticoids', 'triamcinolone acetonide', 'prednisone', 'Glucocorticoid', 'prednisone acetate']","['expression of TGF-β1 and Collagen-I protein', 'expression of carbohydrate sulfotransferase15 (CHST15) mRNA, TGF-β1 and Collagen-Ⅰ protein', 'scores of the Atkinson classification and QLQ-OES18', 'endoscopic stent dilatation times ', 'stenosis rates, endoscopic stent dilatation times, the scores of the Atkinson classification and QLQ-OES18', 'stenosis rates', 'expression of CHST15 mRNA']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C1439099', 'cui_str': 'CHST15 protein, human'}]",,0.0551518,"Compared with the control group, the expression of CHST15 mRNA in oral prednisone acetate group was down-regulated ( P <0.001), and was the lowest in oral prednisone acetate combined with local injection Triamcinolone acetonide group ( P <0.001).","[{'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing 210009, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing 210009, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing 210009, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing 210009, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing 210009, China.'}, {'ForeName': 'G Q', 'Initials': 'GQ', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, Zhongda Hospital, Southeast University, Nanjing 210009, China.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing 210009, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20210905-02024']
1709,35697450,Can electronic monitoring with a digital smart spacer support personalised medication adherence and inhaler technique education in patients with asthma?: Protocol of the randomised controlled OUTERSPACE trial.,"INTRODUCTION


Medication adherence and inhaler technique in patients with asthma remain suboptimal. A digital, smart spacer may support personalised adherence and inhaler technique education. The aim of this study is to assess the feasibility of undertaking a definitive randomised controlled trial of personalised, smart spacer data-driven education and explore clinical benefits.
METHODS AND ANALYSIS


We present the design of the multicentre, randomised controlled OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE feasibility trial of 2 months. Patients will be recruited from four Dutch general practices. At t=-1, patients with asthma ≥18 years using inhaled corticosteroids±long-acting beta-agonists±short-acting beta-agonists administered with a pressurised-metered-dose-inhaler and spacer (n=40) will use a smart spacer for 1 month. The rechargeable CE-marked smart spacer (Aerochamber Plus with Flow Vu) includes a sensor that monitors adherence and inhalation technique to prescribed dosing regimen of both maintenance and reliever inhalers. After 1 month (t=0), patients are 1:1 randomised into two groups: control group (usual care) versus intervention group (personalised education). At t=-1, t=0 and t=1 month, the Asthma Control Questionnaire (ACQ), Work Productivity and Activity Impairment (WPAI) questionnaire and Test of Adherence to Inhalers (TAI) are administered and fractional exhaled nitric oxide (FeNO) is assessed. At t=0 and t=1, spirometry is performed. At t=1, usability and satisfaction will be analysed using the System Usability Scale and interviews with patients and healthcare providers. Primary outcome is the overall feasibility of a definitive trial assessed by patient recruitment speed, participation and drop-out rate. Secondary outcomes are patient and healthcare provider satisfaction and exploratory clinical outcomes are adherence, inhaler technique, TAI score, FeNO, lung function, ACQ and WPAI.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the RTPO in Leeuwarden, Netherlands (number: NL78361.099.21). Patients will provide written informed consent. Study findings will be disseminated through conferences and peer-reviewed scientific and professional journals.
TRIAL REGISTRATION NUMBER


NL9637.",2022,"At t=1, usability and satisfaction will be analysed using the System Usability Scale and interviews with patients and healthcare providers.","['patients with asthma', 'patients with asthma remain suboptimal', 'Patients will be recruited from four Dutch general practices', 'patients with asthma ≥18 years using']","['inhaled corticosteroids±long-acting beta-agonists±short-acting beta-agonists administered with a pressurised-metered-dose-inhaler and spacer', 'control group (usual care) versus intervention group (personalised education', 'CE-marked smart spacer (Aerochamber Plus with Flow Vu', 'Tailored Education and Retraining']","['patient and healthcare provider satisfaction and exploratory clinical outcomes are adherence, inhaler technique, TAI score, FeNO, lung function, ACQ and WPAI', 'overall feasibility of a definitive trial assessed by patient recruitment speed, participation and drop-out rate', 'Asthma Control Questionnaire (ACQ), Work Productivity and Activity Impairment (WPAI) questionnaire and Test of Adherence to Inhalers (TAI) are administered and fractional exhaled nitric oxide (FeNO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",40.0,0.132246,"At t=1, usability and satisfaction will be analysed using the System Usability Scale and interviews with patients and healthcare providers.","[{'ForeName': 'Boudewijn H J', 'Initials': 'BHJ', 'LastName': 'Dierick', 'Affiliation': 'Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Achterbosch', 'Affiliation': 'Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Been-Buck', 'Affiliation': 'Department of Pulmonology, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Titia', 'Initials': 'T', 'LastName': 'Klemmeier', 'Affiliation': 'Department of Pulmonology, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Susanne J', 'Initials': 'SJ', 'LastName': 'van de Hei', 'Affiliation': 'Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hagedoorn', 'Affiliation': 'Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands.'}, {'ForeName': 'Janwillem W H', 'Initials': 'JWH', 'LastName': 'Kocks', 'Affiliation': 'Medication Adherence Expertise Center of the northern Netherlands (MAECON), Groningen, The Netherlands.'}, {'ForeName': 'Job F M', 'Initials': 'JFM', 'LastName': 'van Boven', 'Affiliation': 'Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands j.f.m.van.boven@umcg.nl.'}]",BMJ open,['10.1136/bmjopen-2021-059929']
1710,35697444,PrEggNut Study: protocol for a randomised controlled trial investigating the effect of a maternal diet rich in eggs and peanuts from <23 weeks' gestation during pregnancy to 4 months' lactation on infant IgE-mediated egg and peanut allergy outcomes.,"INTRODUCTION


Clinical studies supported by immunological data indicate early life intervention strategies to be promising in reducing the growing global burden of food allergies. The events that predispose to food allergy, including the induction of allergen-specific immune responses, appear to be initiated early in development. Early exposure to food allergens in utero and via breast milk is likely to be important in initiating oral tolerance. We aim to determine the effectiveness of higher maternal food allergen consumption during pregnancy and lactation on infant food allergy outcomes.
METHODS AND ANALYSIS


This is a multisite, parallel, two-arm (1:1 allocation), single-blinded (outcome assessors, statistical analyst and investigators), randomised controlled trial. Pregnant women (<23 weeks' gestation) whose (unborn) infants have at least two biological family members (mother, father or siblings) with medically diagnosed allergic disease are eligible to participate. After obtaining written informed consent, pregnant women are randomised to either a high egg and peanut diet (at least 6 eggs and 60 peanuts per week) or standard (low) egg and peanut diet (no more than 3 eggs and 30 peanuts per week). The women are asked to follow their allocated diet from <23 weeks' gestation to 4 months' lactation. The primary outcome is food challenge proven IgE-mediated egg and/or peanut allergy in the infants at 12 months of age. Key secondary outcomes include infant sensitisation to egg and/or peanut and infant eczema. Our target sample size is 2136 women. Analyses will be performed on an intention-to-treat basis according to a pre-specified statistical analysis plan.
ETHICS AND DISSEMINATION


Ethical approval has been granted from the Women's and Children's Health Network Human Research Ethics Committee (approval number HREC/18/WCHN/42). Trial results will be presented at scientific conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry ACTRN12618000937213.",2022,Key secondary outcomes include infant sensitisation to egg,"['2136\u2009women', 'pregnant women', ""Pregnant women (<23 weeks' gestation) whose (unborn) infants have at least two biological family members (mother, father or siblings) with medically diagnosed allergic disease are eligible to participate"", ""in eggs and peanuts from <23 weeks' gestation during pregnancy to 4\u2009months' lactation on infant IgE-mediated egg and peanut allergy outcomes""]","['maternal diet rich', 'high egg and peanut diet (at least 6 eggs and 60 peanuts per week) or standard (low) egg and peanut diet']","['infant sensitisation to egg', 'food challenge proven IgE-mediated egg and/or peanut allergy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1266852', 'cui_str': 'Blood relative'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}]",,0.392327,Key secondary outcomes include infant sensitisation to egg,"[{'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Palmer', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Nedlands, Western Australia, Australia debbie.palmer@telethonkids.org.au.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Sullivan', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': 'Discipline of Child and Adolescent Health, The University of Sydney, Lidcombe, New South Wales, Australia.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Nanan', 'Affiliation': 'Charles Perkins Center, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gold', 'Affiliation': 'Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Hsu', 'Affiliation': 'Discipline of Child and Adolescent Health, The University of Sydney, Lidcombe, New South Wales, Australia.'}, {'ForeName': 'Merryn J', 'Initials': 'MJ', 'LastName': 'Netting', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'McWilliam', 'Affiliation': 'Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Koplin', 'Affiliation': 'Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Kirsten P', 'Initials': 'KP', 'LastName': 'Perrett', 'Affiliation': ""Department of Allergy and Immunology, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Quinn', 'Affiliation': 'Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'Faculty of Medicine Dentistry and Health Sciences, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Grivell', 'Affiliation': 'Department of Obstetrics Gynaecology and Reproductive Medicine, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2021-056925']
1711,35697440,"The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vertebral fragility fractures.","INTRODUCTION


Vertebral fragility fractures (VFFs) are the most common type of osteoporotic fracture found in older people, resulting in increasing morbidity and excess mortality. These fractures can cause significant pain, requiring admission to hospital. Vertebroplasty (VP) is effective in reducing pain and allowing early mobilisation in hospitalised patients. However, it may be associated with complications such as cement leakage, infection, bleeding at the injection site and fracture of adjacent vertebrae. It is also costly and not readily accessible in many UK hospitals.A recent retrospective study reported that spinal medial branch nerve block (MBNB), typically used to treat facet arthropathy, had similar efficacy in terms of pain relief compared with VP for the treatment of painful VFF. However, to date, no study has prospectively compared MBNB to VP. We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients.
METHOD


A parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. Follow-up will be at weeks 1, 4 and 8 post intervention. The primary objective is to determine the feasibility and design of a future trial, including specific outcomes of recruitment, adherence to randomisation and safety. Embedded within the trial will be a health economic evaluation to understand resource utilisation and implications of the intervention and a qualitative study of the experiences and insights of trial participants and clinicians. Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data.
ETHICS AND DISSEMINATION


Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee ( reference 21/YH/0065 ). AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority ( reference IRAS 293210 ) and is sponsored by Nottingham University Hospitals NHS Trust ( reference 21HC001 ). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion.
TRIAL REGISTRATION NUMBER


ISRCTN18334053.",2022,"We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients.
","['hospitalised older patients with vertebral fragility fractures', 'hospitalised older patients', 'hospitalised patients', 'hospitalised patients aged over 70 with acute osteoporotic vertebral fractures']","['Vertebroplasty (VP', 'standard care-VP or MBNB', 'spinal medial branch nerve block (MBNB', 'spinal medial branch nerve block']","['pain scores, analgesia requirements, resource use and quality of life data']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}]","[{'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.178523,"We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients.
","[{'ForeName': 'Chia Wei', 'Initials': 'CW', 'LastName': 'Tan', 'Affiliation': 'Health Care of the Older People, Nottingham University Hospitals NHS Trust, Nottingham, UK cwtan@doctors.org.uk.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'Health Care of the Older People, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Arlachov', 'Affiliation': 'Department of Radiology, Nottingham University Hospitals NHS Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Bastounis', 'Affiliation': 'Division of Epidemiology & Public Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bishop', 'Affiliation': 'Nottingham University Business School, Nottingham University, Nottingham, UK.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Czernicki', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Fakis', 'Affiliation': 'Derby Clinical Trials Support Unit, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Dritan', 'Initials': 'D', 'LastName': 'Pasku', 'Affiliation': 'Centre for Spinal Studies and Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Opinder', 'Initials': 'O', 'LastName': 'Sahota', 'Affiliation': 'Health Care of the Older People, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}]",BMJ open,['10.1136/bmjopen-2021-059194']
1712,35697438,"PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal use of antibiotics in the emergency department (PRONTO): protocol for a multicentre, open-label, randomised controlled trial.","INTRODUCTION


Sepsis is a common, potentially life-threatening complication of infection. The optimal treatment for sepsis includes prompt antibiotics and intravenous fluids, facilitated by its early and accurate recognition. Currently, clinicians identify and assess severity of suspected sepsis using validated clinical scoring systems. In England, the National Early Warning Score 2 (NEWS2) has been mandated across all National Health Service (NHS) trusts and ambulance organisations. Like many clinical scoring systems, NEWS2 should not be used without clinical judgement to determine either the level of acuity or a diagnosis. Despite this, there is a tendency to overemphasise the score in isolation in patients with suspected infection, leading to the overprescription of antibiotics and potentially treatment-related complications and rising antimicrobial resistance. The biomarker procalcitonin (PCT) has been shown to be useful in specific circumstances to support appropriate antibiotics prescribing by identifying bacterial infection. PCT is not routinely used in the care of undifferentiated patients presenting to emergency departments (EDs), and the evidence base of its optimal usage is poor. The PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal (PRONTO) study is a randomised controlled trial (RCT) in adults with suspected sepsis presenting to the ED to compare standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment with standard clinical management based on NEWS2 scoring alone and compare if this approach reduces prescriptions of antibiotics without increasing mortality.
METHODS AND ANALYSIS


PRONTO is a parallel two-arm open-label individually RCT set in up to 20 NHS EDs in the UK with a target sample size of 7676 participants. Participants will be randomised in a ratio of 1:1 to standard clinical management based on NEWS2 scoring or standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment. We will compare whether the addition of PCT measurement to NEWS2 scoring can lead to a reduction in intravenous antibiotic initiation in ED patients managed as suspected sepsis, with at least no increase in 28-day mortality compared with NEWS2 scoring alone (in conjunction with local standard care pathways). PRONTO has two coprimary endpoints: initiation of intravenous antibiotics at 3 hours (superiority comparison) and 28-day mortality (non-inferiority comparison). The study has an internal pilot phase and group-sequential stopping rules for effectiveness and futility/safety, as well as a qualitative substudy and a health economic evaluation.
ETHICS AND DISSEMINATION


The trial protocol was approved by the Health Research Authority (HRA) and NHS Research Ethics Committee (Wales REC 2, reference 20/WA/0058). In England and Wales, the law allows the use of deferred consent in approved research situations (including ED studies) where the time dependent nature of intervention would not allow true informed consent to be obtained. PRONTO has approval for a deferred consent process to be used. Findings will be disseminated through peer-reviewed journals and presented at scientific conferences.
TRIAL REGISTRATION NUMBER


ISRCTN54006056.",2022,"The PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal (PRONTO) study is a randomised controlled trial (RCT) in adults with suspected sepsis presenting to the ED to compare standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment with standard clinical management based on NEWS2 scoring alone and compare if this approach reduces prescriptions of antibiotics without increasing mortality.
","['adults with suspected sepsis presenting to the ED', 'patients with suspected infection', 'UK with a target sample size of 7676 participants']","['standard clinical management based on NEWS2 scoring or standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment', 'PROcalcitonin and NEWS2 evaluation', 'PCT']","['28-day mortality', 'initiation of intravenous antibiotics at 3\u2009hours (superiority comparison) and 28-day mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",7676.0,0.0414745,"The PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal (PRONTO) study is a randomised controlled trial (RCT) in adults with suspected sepsis presenting to the ED to compare standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment with standard clinical management based on NEWS2 scoring alone and compare if this approach reduces prescriptions of antibiotics without increasing mortality.
","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Euden', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK eudenj@cardiff.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Aston', 'Affiliation': 'Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Carman', 'Affiliation': 'PPI representative, Lancashire, UK.'}, {'ForeName': 'Enitan', 'Initials': 'E', 'LastName': 'Carrol', 'Affiliation': 'Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Howard', 'Affiliation': 'School of Healthcare, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Inada-Kim', 'Affiliation': 'Acute Medicine, Hampshire Hospitals NHS Foundation Trust, Winchester, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Llewelyn', 'Affiliation': 'Infectious Diseases and Therapeutics, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McGill', 'Affiliation': 'Departments of Infectious Diseases and Medical Microbiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Milosevic', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Louis Wihelmus', 'Initials': 'LW', 'LastName': 'Niessen', 'Affiliation': 'Health Economics, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Nsutebu', 'Affiliation': 'Tropical and Infectious Diseases Division, Sheikh Shakhbout Medical City, Abu Dabi, UAE.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Pallmann', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Schmidt', 'Affiliation': 'Acute Medical Unit, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taylor-Robinson', 'Affiliation': 'Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Welters', 'Affiliation': 'Institute for Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Todd', 'Affiliation': 'Tropical and Infectious Disease Unit, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'French', 'Affiliation': 'Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2022-063424']
1713,35698094,Assessing COVID-19 testing strategies in K-12 schools in underserved populations: study protocol for a cluster-randomized trial.,"BACKGROUND


Since March 2020, COVID-19 has disproportionately impacted communities of color within the United States. As schools have shifted from virtual to in-person learning, continual guidance is necessary to understand appropriate interventions to prevent SARS-CoV-2 transmission. Weekly testing of students and staff for SARS-CoV-2 within K-12 school setting could provide an additional barrier to school-based transmission, especially within schools unable to implement additional mitigation strategies and/or are in areas of high transmission. This study seeks to understand the role that weekly SARS-CoV-2 testing could play in K-12 schools. In addition, through qualitative interviews and listening sessions, this research hopes to understand community concerns and barriers regarding COVID-19 testing, COVID-19 vaccine, and return to school during the COVID-19 pandemic.
METHODS/DESIGN


Sixteen middle and high schools from five school districts have been randomized into one of the following categories: (1) Weekly screening + symptomatic testing or (2) Symptomatic testing only. The primary outcome for this study will be the average of the secondary attack rate of school-based transmission per case. School-based transmission will also be assessed through qualitative contact interviews with positive contacts identified by the school contact tracers. Lastly, new total numbers of weekly cases and contacts within a school-based quarantine will provide guidance on transmission rates. Qualitative focus groups and interviews have been conducted to provide additional understanding to the acceptance of the intervention and barriers faced by the community regarding SARS-CoV-2 testing and vaccination.
DISCUSSION


This study will provide greater understanding of the benefit that weekly screening testing can provide in reducing SARS-CoV-2 transmission within K-12 schools. Close collaboration with community partners and school districts will be necessary for the success of this and similar studies.
TRIAL REGISTRATION


NCT04875520 . Registered May 6, 2021.",2022,This study will provide greater understanding of the benefit that weekly screening testing can provide in reducing SARS-CoV-2 transmission within K-12 schools.,"['K-12 schools in underserved populations', 'K-12 schools', 'Sixteen middle and high schools from five school districts', 'students and staff for SARS-CoV-2 within K-12 school setting']",['Weekly screening\u2009+\u2009symptomatic testing or (2) Symptomatic testing only'],['average of the secondary attack rate of school-based transmission per case'],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",,0.158841,This study will provide greater understanding of the benefit that weekly screening testing can provide in reducing SARS-CoV-2 transmission within K-12 schools.,"[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hayes', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA. sara.malone@wustl.edu.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Bonty', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Mueller', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Summer M', 'Initials': 'SM', 'LastName': 'Reyes', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sydney A', 'Initials': 'SA', 'LastName': 'Reyes', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Myisha', 'Initials': 'M', 'LastName': 'Wilcher-Roberts', 'Affiliation': ''}, {'ForeName': 'Tremayne', 'Initials': 'T', 'LastName': 'Watterson', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sewuese', 'Initials': 'S', 'LastName': 'Akuse', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jamee', 'Initials': 'J', 'LastName': 'Shelley', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Yuan', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Lackey', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Prater', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Brock', 'Initials': 'B', 'LastName': 'Montgomery', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Sheretta T', 'Initials': 'ST', 'LastName': 'Butler-Barnes', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Caburnay', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Nikole Lobb', 'Initials': 'NL', 'LastName': 'Dougherty', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lai', 'Affiliation': 'Department of Medicine, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Neidich', 'Affiliation': 'Department of Pathology and Immunology, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Fritz', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Newland', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}]",BMC public health,['10.1186/s12889-022-13577-z']
1714,35693290,The efficacy of anlotinib as third-line treatment for non-small cell lung cancer by EGFR mutation status: a subgroup analysis of the ALTER0303 randomized phase 3 study.,"Background


Anlotinib demonstrated improved overall survival (OS) and progression-free survival (PFS) compared with placebo as a third-line or subsequent therapy in patients with non-small cell lung cancer (NSCLC) in the ALTER0303 trial. The status of epidermal growth factor receptor (EGFR) mutation, different previous treatment may affect the efficacy of subsequent therapy, and we did this subgroup analysis to characterize the efficacy of anlotinib in patients with and without EGFR mutation.
Methods


The ALTER0303 trial was a randomized, double-blind, phase 3 study of anlotinib in patients with NSCLC who failed at least 2 lines of treatment. In the study, 138 of 437 randomized patients were EGFR mutation positive. A Cox model was used to examine the influence of previous treatment on the efficacy of anlotinib according to EGFR mutation status.
Results


For patients with EGFR mutation, the OS was 10.7 and 6.3 months (HR 0.59; 95% CI: 0.38-0.94, P=0.025) in the anlotinib and placebo group, respectively. The PFS was 5.6 and 0.8 months (HR 0.21; 95% CI: 0.13-0.32, P<0.0001) in the anlotinib and placebo group, respectively. For patients without EGFR mutation, the OS was 8.9 months for anlotinib and 6.5 months for placebo (HR 0.73; 95% CI: 0.55-0.97, P=0.029), and the PFS was 5.4 months for anlotinib and 1.6 months for placebo (HR 0.29; 95% CI: 0.22-0.39, P<0.0001). In the anlotinib group, the OS and PFS for patients with and without EGFR mutation was 10.7 and 8.9 months (HR 0.69; 95% CI: 0.50-0.95, P=0.021), 5.6 and 5.4 months (HR 1.00; 95% CI: 0.75-1.34, P=1.000), respectively. The incidence of adverse events was similar in subgroups.
Conclusions


This analysis demonstrated that the benefit of anlotinib as a third-line therapy for patients with NSCLC was independent of EGFR mutation status.",2022,"The incidence of adverse events was similar in subgroups.
","['patients with NSCLC who failed at least 2 lines of treatment', 'patients with and without EGFR mutation', '138 of 437 randomized patients were EGFR mutation positive', 'non-small cell lung cancer by EGFR mutation status', 'patients with NSCLC', 'patients with non-small cell lung cancer (NSCLC']",['placebo'],"['OS and PFS', 'adverse events', 'overall survival (OS) and progression-free survival (PFS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",437.0,0.580343,"The incidence of adverse events was similar in subgroups.
","[{'ForeName': 'Yizhuo', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Diseases, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Zhehai', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine-Oncology, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Thoracic Medical Oncology, Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yuankai', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Weiqiang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary Medicine, Lanzhou Military General Hospital, Lanzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Chemotherapy, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Kejun', 'Initials': 'K', 'LastName': 'Nan', 'Affiliation': ""Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Faguang', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ""Department of Respiratory Diseases, Tang Du Hospital, Xi'an, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'First Department of Medical Oncology, Yunnan Cancer Hospital, Kunming, China.'}, {'ForeName': 'Baolan', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of General Medicine, Capital Medical University, Beijing Chest Hospital, Beijing, China.'}, {'ForeName': 'Fumihiro', 'Initials': 'F', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Respiratory Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Breadner', 'Affiliation': 'Division of Medical Oncology, London Regional Cancer Program at London Health Science Center, London, Canada.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Fumihiro', 'Initials': 'F', 'LastName': 'Tanaka', 'Affiliation': 'Second Department of Surgery, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Hatim', 'Initials': 'H', 'LastName': 'Husain', 'Affiliation': 'Division of Hematology and Oncology, Moores Cancer Center, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}]",Translational lung cancer research,['10.21037/tlcr-22-320']
1715,35693264,Effects of Early Nursing Monitoring on Pregnancy Outcomes of Pregnant Women with Gestational Diabetes Mellitus under Internet of Things.,"To analyze the effect of early nursing intervention based on fetal heart signal extraction algorithm and Internet of Things (IoT) wireless communication technology on the adverse pregnancy outcomes of pregnant women with gestational diabetes mellitus (GDM) and newborns, 88 pregnant women diagnosed with GDM who underwent the 75 g glucose tolerance test at 24-28 gestational weeks in the hospital were selected as the research objects. According to the different intervention methods, the patients were divided into 44 cases of the experimental group (nursing intervention based on maternal and infant monitoring system) and 44 cases of the control group (outpatient follow-up intervention). The results showed that the compliance score and diet compliance rate of patients in the experimental group were signally higher than those in the control group at 1 and 3 months after intervention ( P  < 0.05). The levels of fasting blood glucose (FBG), blood glucose 2 hours after the meal, and hemoglobin A1c (HbA1c) in the experimental group were lower than those in the control group at 1 and 3 months after intervention ( P  < 0.05). The number of giant babies, hypoglycemia, hyperbilirubinemia, fetal distress, premature delivery, and birth weight in the experimental group was all lower than those in the control group, while the Apgar scores were higher than that in the control group ( P  < 0.05). To sum up, the intervention based on the intelligent maternal and infant monitoring system could timely help pregnant women adjust their diet structure and optimize the management of blood glucose and blood lipids, thus effectively improving the adverse pregnancy outcome and maintaining the health of pregnant women and newborns.",2022,"The levels of fasting blood glucose (FBG), blood glucose 2 hours after the meal, and hemoglobin A1c (HbA1c) in the experimental group were lower than those in the control group at 1 and 3 months after intervention ( P  < 0.05).","['pregnant women with gestational diabetes mellitus (GDM) and newborns, 88 pregnant women diagnosed with GDM who underwent the 75\u2009g glucose tolerance test at 24-28 gestational weeks in the hospital were selected as the research objects', 'Pregnant Women with Gestational Diabetes Mellitus under Internet of Things', 'pregnant women and newborns']","['early nursing intervention based on fetal heart signal extraction algorithm and Internet of Things (IoT) wireless communication technology', 'Early Nursing Monitoring', 'experimental group (nursing intervention based on maternal and infant monitoring system']","['levels of fasting blood glucose (FBG), blood glucose 2 hours after the meal, and hemoglobin A1c (HbA1c', 'compliance score and diet compliance rate', 'number of giant babies, hypoglycemia, hyperbilirubinemia, fetal distress, premature delivery, and birth weight', 'Pregnancy Outcomes', 'Apgar scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C5197895', 'cui_str': 'Internet of Things'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015935', 'cui_str': 'Fetal Heart'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C5197895', 'cui_str': 'Internet of Things'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1272406', 'cui_str': 'Encouragement of dietary compliance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring fetal status'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}]",88.0,0.0103286,"The levels of fasting blood glucose (FBG), blood glucose 2 hours after the meal, and hemoglobin A1c (HbA1c) in the experimental group were lower than those in the control group at 1 and 3 months after intervention ( P  < 0.05).","[{'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Department of Obstetrics, Chenzhou No.1 People's Hospital, Chenzhou, 423000 Hunan, China.""}, {'ForeName': 'Tinglan', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': ""Department of Obstetrics, Chenzhou No.1 People's Hospital, Chenzhou, 423000 Hunan, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/8535714']
1716,35693258,Ultrasound Images under an Optimized Image Processing Algorithm in Guiding the Neurological Safety of Resection of Lumbar Disc Nucleus Pulposus in Spinal Surgery.,"This study was aimed at investigating the effect of an optimized image processing algorithm in ultrasound images and the influence of resection of lumbar disc nucleus pulposus in spinal surgery under the guidance of ultrasound images on the neurological safety of patients. A total of 60 patients with lumbar disc herniation were selected and divided randomly into the control group and observation group. Patients from the control group were treated with resection of lumbar disc nucleus pulposus by an X-ray-guided foraminal microscope, and patients from the observation group underwent the ultrasound image-guided surgeries with an optimized image processing algorithm. Then, the treatment of patients from the two groups was compared. The results showed that the radiotherapy time in the control group was 120 ± 6.3 min and the radiotherapy dose was 129 ± 10.3 min/sec, while the radiotherapy time in the observation group was 4.5 ± 1.2 min and the radiotherapy dose was 22 ± 7.7 min/sec. The time and dose of radiotherapy in the observation group were significantly lower than those in the control group ( P  < 0.05). In the control group, the numbers of significant effective cases, effective cases, and ineffective cases were 8, 16, and 6, respectively, while those in the observation group were 12, 18, and 0, respectively. The comparison between the groups showed that the number of effective cases and the number of effective cases in the observation group were significantly higher than those in the control group, and the number of ineffective cases was significantly lower than that in the control group ( P  < 0.05). In conclusion, ultrasound-guided percutaneous foraminal lumbar discectomy could improve patients' clinical symptoms, promote clinical efficacy, and reduce postoperative pain symptoms, thereby accelerating the postoperative rehabilitation of patients. Moreover, it was extremely safe for the nerves.",2022,The time and dose of radiotherapy in the observation group were significantly lower than those in the control group ( P  < 0.05).,"['patients', '60 patients with lumbar disc herniation', 'Spinal Surgery']","['resection of lumbar disc nucleus pulposus by an X-ray-guided foraminal microscope, and patients from the observation group underwent the ultrasound image-guided surgeries with an optimized image processing algorithm']","['postoperative pain symptoms', 'number of ineffective cases', 'number of effective cases', 'time and dose of radiotherapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1185714', 'cui_str': 'Nucleus Pulposus'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0441996', 'cui_str': 'Foraminal'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0969690', 'cui_str': 'Image-Guided Surgery'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",60.0,0.0113243,The time and dose of radiotherapy in the observation group were significantly lower than those in the control group ( P  < 0.05).,"[{'ForeName': 'Kaiwei', 'Initials': 'K', 'LastName': 'Yin', 'Affiliation': ""Department of Orthopedics, Dongyang Garden Tian's Hospital, Dongyang, Jinhua, 322100 Zhejiang, China.""}, {'ForeName': 'Yehai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopedics, Dongyang Garden Tian's Hospital, Dongyang, Jinhua, 322100 Zhejiang, China.""}, {'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': ""Department of Orthopedics, Dongyang Garden Tian's Hospital, Dongyang, Jinhua, 322100 Zhejiang, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/3232670']
1717,35693254,Effect of Sandplay Therapy on the Mental Health Level of College Students.,"To analyze the effect of sandplay (SP) therapy on the mental health level of college students. 500 college students were openly recruited, using the University Student Mental Health Questionnaire (UPI) to screen out 76 students in the UPI category. 34 college students were randomly selected and divided into two groups, 17 in the control group and 17 in the SP therapy group (experimental group); the control group received no treatment, and the experimental group was treated with SP therapy, to analyze the differences between groups before and after the intervention of SCL-90 and self-made group self-reflection questionnaire. (1) With a detection rate of 15.2 percent, 76 of the 500 college students solicited openly were identified as UPI students; (2) except for the terror factor, there were significant differences in other aspects and overall scores for the experimental group following SP therapy intervention, and the scores reduced. There were no significant differences in the total scores and scores of all factors in the control group ( P  > 0.05). The overall score, somatization, interpersonal connection, depression, paranoia, and psychosis were all significantly different between the experimental and control groups in the independent sample  t -test ( P  < 0.05).",2022,There were no significant differences in the total scores and scores of all factors in the control group ( P  > 0.05).,"['Mental Health Level of College Students', '34 college students', '500 college students were openly recruited, using the University Student Mental Health Questionnaire (UPI) to screen out 76 students in the UPI category', 'mental health level of college students']","['control group received no treatment, and the experimental group was treated with SP therapy', 'Sandplay Therapy', 'sandplay (SP) therapy', 'SP therapy', 'SCL-90 and self-made group self-reflection questionnaire']","['overall score, somatization, interpersonal connection, depression, paranoia, and psychosis', 'total scores and scores of all factors']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2350829', 'cui_str': 'Sandplay'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",500.0,0.0082988,There were no significant differences in the total scores and scores of all factors in the control group ( P  > 0.05).,"[{'ForeName': 'Gaoyong', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'School of Economics Management, Kaili University, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'School of Economics Management, Kaili University, China.'}]",Computational and mathematical methods in medicine,['10.1155/2022/3716849']
1718,35693195,"Effect of Bhramari Pranayama intervention on stress, anxiety, depression and sleep quality among COVID 19 patients in home isolation.","Background


COVID-19 outbreak is considered to be a major public health concern as it has a negative impact on the patient's psychological health. In addition, patients under home isolation might be more panic and in stress. In this study, we examined the effect of Bhramari Pranayama (Bhr.P) intervention on patients' psychological distress during home isolation.
Methods


Ninety-two asymptomatic COVID-19 patients were recruited from the host hospital and willing patients who satisfied the inclusion criteria (n= 42) were selected for the study. The patients were given Bhr.P intervention (20 min) through online for 15 days. Participants were assessed with Depression Anxiety and Stress Scale-21(DASS-21), Pittsburgh Sleep Quality Index (PSQI), and Quality of life (WHOQOL-BREF) at baseline and post-intervention.
Results


Bhr.P practice has shown a significant (P<0.05) reduction in DASS-21 score of depression, anxiety and stress. In addition, the patients stated significant improvement in quality of sleep (PSQI; p<0.05) and quality of life (WHOQOL-BREF; p<0.05) after the intervention.
Conclusion


Our findings indicate that Bhr.P intervention had a positive impact on psychological health as well as quality of sleep among the COVID-19 patients during home isolation. However, it needs to be confirmed by multi-site randomized controlled trials.
Clinical trial registration


CTRI/2021/04/032845.",2022,"P practice has shown a significant (P<0.05) reduction in DASS-21 score of depression, anxiety and stress.","[""patients' psychological distress during home isolation"", 'Methods\n\n\nNinety-two asymptomatic COVID-19 patients were recruited from the host hospital and willing patients who satisfied the inclusion criteria (n= 42) were selected for the study', 'COVID 19 patients in home isolation']","['Bhramari Pranayama intervention', 'Bhramari Pranayama (Bhr.P) intervention']","['quality of sleep', 'quality of sleep (PSQI; p<0.05) and quality of life', 'stress, anxiety, depression and sleep quality', 'DASS-21 score of depression, anxiety and stress', 'psychological health', 'Depression Anxiety and Stress Scale-21(DASS-21), Pittsburgh Sleep Quality Index (PSQI), and Quality of life (WHOQOL-BREF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",92.0,0.0346918,"P practice has shown a significant (P<0.05) reduction in DASS-21 score of depression, anxiety and stress.","[{'ForeName': 'Thanalakshmi', 'Initials': 'T', 'LastName': 'Jagadeesan', 'Affiliation': 'Department of Physiology, Saveetha Medical College, Thanadalam.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'R', 'Affiliation': 'Department of Physiology, Saveetha Medical College, Thanadalam.'}, {'ForeName': 'Kannan', 'Initials': 'K', 'LastName': 'R', 'Affiliation': 'Department of General medicine, Saveetha Medical College and Hospital, Thanadalam.'}, {'ForeName': 'Timsi', 'Initials': 'T', 'LastName': 'Jain', 'Affiliation': 'Department of Community medicine, Saveetha Medical College and Hospital, Thanadalam.'}, {'ForeName': 'Aadhyyanth R', 'Initials': 'AR', 'LastName': 'Allu', 'Affiliation': 'Saveetha Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Tamil', 'Initials': 'T', 'LastName': 'Selvi G', 'Affiliation': 'Department of Physiology, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maveeran', 'Affiliation': 'Annai College of Naturopathy and Yoga Science, Kovilacheri, Kumbakonam.'}, {'ForeName': 'Maheshkumar', 'Initials': 'M', 'LastName': 'Kuppusamy', 'Affiliation': 'Assistant Medical officer/Lecture Grade II, Department of Physiology and Biochemistry, Government Yoga and Naturopathy Medical college & Hospital, Arumbakkam, Chennai.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2022.100596']
1719,35693149,"The Relationship Between Helmet Weight, Cognitive Performance, and Mental Workload.","Introduction


This study sought to examine the effects of helmet weight on cognitive performance and mental workload. Twenty participants were studied in 3 one-hour sessions.
Methods


The study participants were requested to read and work with computers under the following 3 conditions: wearing no helmets, wearing a helmet that weighed 800 g (A), and a helmet weighing 1500 g (B). ""N-back"" task and Continuous Performance Test (CPT) were employed to assess cognitive performance. At the same time, NASA-TLX and Thermal Comfort and Fatigue Perception Scale were used to evaluate mental workload and comfort. At the end of the intervention sessions, perceived mental workload, thermal comfort, and fatigue in the head were measured. Moreover, the research participants' cognitive performance was gauged before and after the sessions.
Results


The present study findings revealed that helmet weight significantly impacted cognitive performance (P<0.001). However, no significant difference was detected in the participants' mental workload before and after the intervention.
Conclusion


Helmet weight could affect cognitive performance. Therefore, in designing helmets, the helmet's weight should be considered an essential factor.
Highlights


Helmet weight significantly impacted cognitive performance.The results showed that the perceived mental workload was not influenced by helmet weight.Designing helmets, the helmet's weight should be considered an essential factor.
Plain Language Summary


This study examined the effect of helmet weight on brain performance. The results showed that the perceived mental workload was not influenced by helmet weight. However, brain performance declined as a result of wearing heavier helmets. Furthermore, the perceived local fatigue in the shoulders and neck increased after wearing heavier helmets. Thus, manufacturers should consider helmet weight while designing helmets and developing the relevant standards.",2021,"However, no significant difference was detected in the participants' mental workload before and after the intervention.
","['Twenty participants were studied in 3 one-hour sessions', 'study participants were requested to read and work with computers under the following 3 conditions']","['wearing no helmets, wearing a helmet that weighed 800 g (A), and a helmet weighing 1500 g (B', 'N-back"" task and Continuous Performance Test (CPT', 'helmet weight']","['Helmet Weight, Cognitive Performance, and Mental Workload', ""participants' mental workload"", 'NASA-TLX and Thermal Comfort and Fatigue Perception Scale', 'cognitive performance and mental workload', 'mental workload, thermal comfort, and fatigue in the head', 'cognitive performance', 'perceived mental workload', 'brain performance']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C1505678', 'cui_str': 'CD46 protein, human'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",20.0,0.0908421,"However, no significant difference was detected in the participants' mental workload before and after the intervention.
","[{'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Zoaktafi', 'Affiliation': 'Department of Ergonomics, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Choobineh', 'Affiliation': 'Department of Ergonomics, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Matin', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Department of Ergonomics, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kazemi', 'Affiliation': 'Department of Ergonomics, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Basic and clinical neuroscience,['10.32598/bcn.2021.1773.1']
1720,35693612,Estimation of the median effective dose and the 95% effective dose of alfentanil required to inhibit the bronchoscopy reaction during painless bronchoscopy with i-gel supraglottic airway device: an Up-and-Down Sequential Allocation Trial.,"Background


In practice, the optimal dose of alfentanil that should be used when painless bronchoscopy is performed is unknown. The purpose of this study was to investigate the effective dose of alfentanil in suppressing bronchoscopy responses to painless bronchoscopy with an i-gel supraglottic airway device.
Methods


Patients aged 18-70 years, with American Society of Anesthesiologists (ASA) physical status I-II, who planned to undergo painless bronchoscopy were recruited for this study. Alfentanil was administered intravenously 2 minutes before propofol administration. The response to bronchoscopy was measured, including oxygen saturation (SPO 2 ) and changes in respiratory rhythm. The median effective dose of alfentanil (ED 50 ) required to alleviate responses to the bronchoscopy was calculated using Dixon's up-and-down method in the female and male groups. Probit analysis was used to generate a dose-response curve in each group.
Results


A total of 48 patients were recruited for the study including 25 females and 23 males. The ED 50  of alfentanil for suppressing responses to painless bronchoscopy in females and males was 13.68±4.75 and 17.96±3.45 µg/kg, respectively. The difference was not statistically significant between the two groups (P=0.078). Probit analysis showed the ED 50  of alfentanil in female bronchoscopy was 12.4 µg/kg [95% confidence interval (CI): 4.5 to 17 µg/kg]. In men, the ED 50  of alfentanil was 16.4 µg/kg (95% CI: 12.1 to 20.1 µg/kg). According to the probit analysis, the 95% effective dose (ED 95 ) of alfentanil was 22.4 µg/kg (95% CI: 17.5 to 67.3 µg/kg) in female bronchoscopy. In men, the ED 95  of alfentanil was 23.3 µg/kg (95% CI: 19.8 to 46.2 µg/kg).
Conclusions


Our data suggest that there were no obvious differences between men and women in the effective dose of alfentanil in painless bronchoscopy.",2022,The difference was not statistically significant between the two groups (P=0.078).,"['48 patients were recruited for the study including 25 females and 23 males', 'painless bronchoscopy with an i-gel supraglottic airway device', 'Methods\n\n\nPatients aged 18-70 years, with American Society of Anesthesiologists (ASA) physical status I-II, who planned to undergo painless bronchoscopy were recruited for this study']","['Alfentanil', 'alfentanil']",['oxygen saturation (SPO 2 ) and changes in respiratory rhythm'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0002026', 'cui_str': 'Alfentanil'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231842', 'cui_str': 'Respiratory rhythm'}]",48.0,0.105932,The difference was not statistically significant between the two groups (P=0.078).,"[{'ForeName': 'Nanjin', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Lingyang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Mingcang', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Yongpo', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Critical Care Medicine, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Taizhou, China.'}]",Journal of thoracic disease,['10.21037/jtd-22-412']
1721,35693439,Evaluation of cardiotoxicity and other adverse effects associated with concomitant administration of artemether/lumefantrine and atazanavir/ritonavir-based antiretroviral regimen in patients living with HIV.,"The interplay of artemether-lumefantrine (AL) and atazanavir-ritonavir (ATVr) with Cytochrome  P  (CYP) 3A4 isoenzyme and QTc-interval may spawn clinically significant drug interactions when administered concomitantly. Cardiotoxicity and other adverse effects associated with interaction between AL and ATVr were evaluated in patients with HIV infection and malaria comorbidity. In a two-arm parallel study design, six doses of AL 80/480 mg were administered to 20 participants [control-arm (n = 10) and ATVr-arm (n = 10)], having uncomplicated Falciparum malaria, at intervals of 0, 8, 24, 36, 48 and 60 h respectively. Participants in the control arm took only AL while those in ATVr-arm took both AL and ATVr-based ART regimen. Electrocardiography, adverse events monitoring and blood tests were carried out for each of them at pre and post doses of AL. Data obtained were analyzed. QTc-interval was significantly increased in the ATVr-arm (0.4079 ± 0.008 to 0.4215 ± 0.007 s,  p  = 0.008) but not in the control-arm (0.4016 ± 0.018 to 0.4024 ± 0.014 s,  p  = 0.962). All values were, however, within normal range [0.36 - 0.44 / 0.46 s (male/female)]. General body weakness and chest pain were new adverse events reported, at post-dose of AL, in the ATVr-arm but not in the control-arm. There was no significant change (p > 0.05) in the plasma levels of creatinine, alanine aminotransferase, aspartate aminotransferase and hemoglobin at post-dose compared to pre-dose of AL in both arms of study. Concomitant administration of artemether-lumefantrine with atazanavir-ritonavir-based regimen is potentially cardiotoxic but not associated with clinically significant renal, blood nor liver toxicities. They must be used with caution.",2022,"There was no significant change (p > 0.05) in the plasma levels of creatinine, alanine aminotransferase, aspartate aminotransferase and hemoglobin at post-dose compared to pre-dose of AL in both arms of study.","['patients with HIV infection and malaria comorbidity', 'patients living with HIV']","['lumefantrine and atazanavir/ritonavir-based antiretroviral regimen', 'artemether-lumefantrine with atazanavir-ritonavir', 'artemether-lumefantrine (AL) and atazanavir-ritonavir (ATVr) with Cytochrome  P  (CYP']","['QTc-interval', 'plasma levels of creatinine, alanine aminotransferase, aspartate aminotransferase and hemoglobin', 'General body weakness and chest pain', 'Cardiotoxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0531104', 'cui_str': 'lumefantrine'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0010798', 'cui_str': 'Cytochrome'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}]","[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}]",,0.102844,"There was no significant change (p > 0.05) in the plasma levels of creatinine, alanine aminotransferase, aspartate aminotransferase and hemoglobin at post-dose compared to pre-dose of AL in both arms of study.","[{'ForeName': 'Sikiru Olatunji', 'Initials': 'SO', 'LastName': 'Usman', 'Affiliation': 'Department of Pharmacology, Therapeutics and Toxicology, College of Medicine of the University of Lagos, Idi-Araba, Lagos State, Nigeria.'}, {'ForeName': 'Ibrahim Adekunle', 'Initials': 'IA', 'LastName': 'Oreagba', 'Affiliation': 'Department of Pharmacology, Therapeutics and Toxicology, College of Medicine of the University of Lagos, Idi-Araba, Lagos State, Nigeria.'}, {'ForeName': 'AbdulWasiu', 'Initials': 'A', 'LastName': 'Busari', 'Affiliation': 'Department of Pharmacology, Therapeutics and Toxicology, College of Medicine of the University of Lagos, Idi-Araba, Lagos State, Nigeria.'}, {'ForeName': 'Akinwumi', 'Initials': 'A', 'LastName': 'Akinyede', 'Affiliation': 'Department of Pharmacology, Therapeutics and Toxicology, College of Medicine of the University of Lagos, Idi-Araba, Lagos State, Nigeria.'}, {'ForeName': 'Ololade', 'Initials': 'O', 'LastName': 'Adewumi', 'Affiliation': 'Department of Pharmacology, Therapeutics and Toxicology, College of Medicine of the University of Lagos, Idi-Araba, Lagos State, Nigeria.'}, {'ForeName': 'Michael Rotimi', 'Initials': 'MR', 'LastName': 'Kadri', 'Affiliation': 'Department of Pharmacology, Therapeutics and Toxicology, College of Medicine of the University of Lagos, Idi-Araba, Lagos State, Nigeria.'}, {'ForeName': 'Olayinka', 'Initials': 'O', 'LastName': 'Hassan', 'Affiliation': 'Lagos University Teaching Hospital (LUTH), Idi-Araba, Lagos State, Nigeria.'}, {'ForeName': 'Yinka Adeyemi', 'Initials': 'YA', 'LastName': 'Fashina', 'Affiliation': 'Department of Pharmacology, Therapeutics and Toxicology, College of Medicine of the University of Lagos, Idi-Araba, Lagos State, Nigeria.'}, {'ForeName': 'Esther Oluwatoyin', 'Initials': 'EO', 'LastName': 'Agbaje', 'Affiliation': 'Department of Pharmacology, Therapeutics and Toxicology, College of Medicine of the University of Lagos, Idi-Araba, Lagos State, Nigeria.'}, {'ForeName': 'Sulaimon Alani', 'Initials': 'SA', 'LastName': 'Akanmu', 'Affiliation': 'Department of Haematology and Blood Transfusion, Faculty of Clinical Science, College of Medicine of the University of Lagos, Idi-Araba, Lagos State, Nigeria.'}]",Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society,['10.1016/j.jsps.2022.02.010']
1722,35693437,The impact of using pictorial aids in caregivers' understanding of patient information leaflets of pediatric pain medications: A quasi-experimental study.,"Introduction


Patient information leaflets (PILs) are one of the main sources of information for over-the-counter medications (OTCs). This study aimed to assess caregivers' understanding of instructions in PILs provided with paracetamol medications and the impact of pictograms use.
Methods


A quasi-experimental study was conducted among caregivers of children aged < 13 years recruited in pediatric outpatient clinics at University Medical City in Riyadh. The calculated sample size was 128; at least 64 participants were needed in each group (the text-only group and the text-plus pictograms group). Caregivers' health literacy was assessed using a validated Arabic version of the Newest Vital Sign scale. Participants' understanding of PILs instructions was assessed using eight questions on the route of administration, minimal hours between doses, max daily dose, shake medication before use, storage, and reporting adverse events; and was rated based on the number of questions correctly understood. Characteristics of participants were compared by Pearson X 2  and  t -test was used to assess the significance of mean score differences between groups.
Results


A total of 130 caregivers participated in the study; almost half of them were mothers (47%, [n = 61]) and 43% (n = 56) have ""a possibility of limited health literacy"". The mean number of correct answers to questions assessing the understanding of PILs instructions was significantly higher among the text-plus pictograms group compared to the text-only group (5.25 ± 1.85 vs. 4.38 ± 1.27;  p  < 0.001). When results were controlled for age and gender, better health literacy was found to be associated with a better understanding of instructions (B = 0.39, 95 %CI 0.23-0.54).
Conclusion


Limited comprehension of medications instructions was observed; adding pictorial aids to PILs might enhance the comprehension. Differences in health literacy levels of caregivers should be considered when designing PILs.",2022,The mean number of correct answers to questions assessing the understanding of PILs instructions was significantly higher among the text-plus pictograms group compared to the text-only group (5.25 ± 1.85 vs. 4.38 ± 1.27;  ,"['caregivers of children aged\xa0<\xa013\xa0years recruited in pediatric outpatient clinics at University Medical City in Riyadh', '130 caregivers participated in the study; almost half of them were mothers (47%, [n\xa0=\xa061]) and 43% (n\xa0=\xa056) have ""a possibility of limited health literacy', ""caregivers' understanding of patient information leaflets of pediatric pain medications""]","['pictorial aids', 'paracetamol medications']","['mean number of correct answers to questions assessing the understanding of PILs instructions', ""Caregivers' health literacy""]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",130.0,0.0997025,The mean number of correct answers to questions assessing the understanding of PILs instructions was significantly higher among the text-plus pictograms group compared to the text-only group (5.25 ± 1.85 vs. 4.38 ± 1.27;  ,"[{'ForeName': 'Aljoharah M', 'Initials': 'AM', 'LastName': 'Algabbani', 'Affiliation': 'Saudi Food and Drug Authority, Riyadh, Saudi Arabia.'}, {'ForeName': 'Khalid A', 'Initials': 'KA', 'LastName': 'Alzahrani', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Sayed', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Meshael', 'Initials': 'M', 'LastName': 'Alrasheed', 'Affiliation': 'Saudi Food and Drug Authority, Riyadh, Saudi Arabia.'}, {'ForeName': 'Deema', 'Initials': 'D', 'LastName': 'Sorani', 'Affiliation': 'Department of Pediatrics, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'Almohammed', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Amani S', 'Initials': 'AS', 'LastName': 'Alqahtani', 'Affiliation': 'Saudi Food and Drug Authority, Riyadh, Saudi Arabia.'}]",Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society,['10.1016/j.jsps.2022.02.017']
1723,35693425,Endotheliopathy is Associated with a 24-hour Fibrinolysis Phenotype Described by Low TEG Lysis and High D-Dimer after Trauma: a Secondary Analysis of the PROPPR Study.,"Objectives


Determine associations between biomarkers of endotheliopathy, 24-hour fibrinolysis phenotypes and clinical outcomes after trauma.
Background


The vascular endothelium is a critical regulator of hemostasis and organ function. The relationship between markers of endotheliopathy and fibrinolysis following trauma has not been evaluated.
Methods


We performed a secondary analysis of prospectively collected biomarker data in the Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) randomized controlled trial. We stratified subjects by 24-hour thromboelastography (TEG) percent clot lysis (LY30) and plasma D-dimer (DD) levels and evaluated differences in endotheliopathy biomarkers and clinical outcomes between subjects with one of four 24-hour fibrinolysis phenotypes: LY30 0.9-2.9% (LY30 norm ), LY30 >2.9% (LY30 high ), LY30 <0.9% and low DD (LY30 low +DD low ), and LY30 <0.9% and high DD (LY30 low +DD high ).
Results


The analysis included 168 subjects with LY30 norm , 32 with LY30 high , 147 with LY30 low +DD low  and 124 with LY30 low +DD high . LY30 low +DD high  subjects had greater injury severity and a higher incidence of severe head injury, multiorgan failure (MOF), and mortality than the other phenotypes. All endotheliopathy biomarkers were significantly higher in the LY30 low +DD high  phenotype. Adjusting for injury severity, mechanism and head trauma, 24-hour angiopoietin-2 and soluble thrombomodulin were independently associated with the LY30 low +DD high  phenotype. Both endothelial biomarkers were discriminating for MOF. Subjects with thrombomodulin level >9.5 ng/mL and angiopoietin-2 level >3.6 ng/mL accounted for 64% of subjects who developed MOF.
Conclusions


In a multicenter trauma cohort, subjects with a fibrinolysis phenotype characterized by low TEG lysis and elevated DD 24 hours after injury have significantly worse endotheliopathy and clinical outcomes. Our findings support mechanistic evaluations of the role of the endothelium in fibrinolysis dysregulation that may drive late-stage organ injury.",2022,"LY30 low +DD high  subjects had greater injury severity and a higher incidence of severe head injury, multiorgan failure (MOF), and mortality than the other phenotypes.","['Subjects with thrombomodulin level >9.5 ng/mL and angiopoietin-2 level ', 'subjects with one of four 24-hour fibrinolysis phenotypes: LY30 0.9-2.9% (LY30 norm ), LY30 >2.9% (LY30 high ), LY30 <0.9% and low DD (LY30 low +DD low ), and LY30 <0.9% and high DD (LY30 low +DD high ', '168 subjects with LY30 norm , 32 with LY30 high , 147 with LY30 low +DD low  and 124 with LY30 low +DD high ']",[],"['24-hour thromboelastography (TEG) percent clot lysis (LY30) and plasma D-dimer (DD) levels', 'injury severity, mechanism and head trauma, 24-hour angiopoietin-2 and soluble thrombomodulin', 'severe head injury, multiorgan failure (MOF), and mortality']","[{'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0540511', 'cui_str': 'Angiopoietin 2'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C4517553', 'cui_str': '124'}]",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0540511', 'cui_str': 'Angiopoietin 2'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",168.0,0.0935338,"LY30 low +DD high  subjects had greater injury severity and a higher incidence of severe head injury, multiorgan failure (MOF), and mortality than the other phenotypes.","[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Richter', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Joiner', 'Affiliation': 'University of Alabama at Birmingham, School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Griffin', 'Affiliation': 'University of Alabama at Birmingham, School of Public Health, Birmingham, Alabama, USA.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Jansen', 'Affiliation': 'Center for Injury Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Kerby', 'Affiliation': 'Center for Injury Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Center for Injury Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Cardenas', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Jillian R', 'Initials': 'JR', 'LastName': 'Richter', 'Affiliation': 'Center for Injury Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]","Annals of surgery open : perspectives of surgical history, education, and clinical approaches",['10.1097/as9.0000000000000116']
1724,35693378,"Overcoming COVID-19 disruptions: Innovations in product provision in a multi-national clinical trial among cisgender men, transgender men and transgender women in five countries.","Clinical trials often depend on participants receiving study product to meet objectives of the protocol. Vitally important are considerations for how sites receive and dispense study product during a study while ensuring appropriate handling, accountability and compliance. The process for provision of study product is detailed in Standard Operating Procedures (SOPs) which are adhered to by the research site throughout the trial. The COVID-19 pandemic unexpectedly affected the ability of study participants to receive study product. We report on the various methods implemented by trial sites to ensure timely provision of study product to participants during this unprecedented pandemic. In MTN-035, participants received 3 potential rectal microbicide formulations in randomized sequences to understand user preferences. Trial sites were permitted to revise dispensing methods to enable participants to continue to receive study product during COVID-19 restrictions. These actions mitigated disruption of study product administration and preserved the integrity of the trial. Out of the 78 participants expecting to receive study products on or after the onset of restrictions due to COVID-19, only four participants (5%) did not receive all three products. Adopting alternative methods to provide product to study participants in extraordinary circumstances was key to successful study completion and maintaining study integrity.",2022,"In MTN-035, participants received 3 potential rectal microbicide formulations in randomized sequences to understand user preferences.","['78 participants expecting to receive study products on or after the onset of restrictions due to COVID-19, only four participants (5%) did not receive all three products', 'cisgender men, transgender men and transgender women in five countries']",['3 potential rectal microbicide formulations'],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C1136254', 'cui_str': 'Antimicrobial-containing product'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]",[],78.0,0.419809,"In MTN-035, participants received 3 potential rectal microbicide formulations in randomized sequences to understand user preferences.","[{'ForeName': 'Jacobson', 'Initials': 'J', 'LastName': 'Cindy', 'Affiliation': 'Magee Womens Research Institute, Pittsburgh, USA.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'Sherri', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Billups', 'Initials': 'B', 'LastName': 'Tarana', 'Affiliation': 'University of Alabama, Birmingham, USA.'}, {'ForeName': 'Mitterer', 'Initials': 'M', 'LastName': 'Lynn', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Chadza', 'Initials': 'C', 'LastName': 'Mary', 'Affiliation': 'Blantyre CRS, Johns Hopkins University Research Project, Blantyre, Malawi.'}, {'ForeName': 'Gumede', 'Initials': 'G', 'LastName': 'Sibuiswe', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'Manoyos', 'Initials': 'M', 'LastName': 'Veruree', 'Affiliation': 'Research Institute for Health Sciences (RIHES) Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pareja', 'Initials': 'P', 'LastName': 'Karina', 'Affiliation': 'IMPACTA, Asociacion Civil Impacta Salud y Educacion, San Miguel CRS, Lima, Peru.'}, {'ForeName': 'Zemanek', 'Initials': 'Z', 'LastName': 'Jillian', 'Affiliation': 'Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Yuqing', 'Affiliation': 'Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Bauermeister', 'Initials': 'B', 'LastName': 'Jose', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2022.100930']
1725,35693377,Avoidance of negative emotional contrast from worry and rumination: An application of the Contrast Avoidance Model.,"According to the Contrast Avoidance model (CAM), worry causes increased and sustained negative affect and such negative affect enables avoidance of a future sharp increase in negative emotion. However, only pathological worriers (vs. controls) view worry as a positive coping strategy to avoid a negative emotional contrast (NEC). We examined if rumination, which is another type of repetitive negative thought, would function similarly. Individuals with self-reported symptoms of pure generalized anxiety disorder (GAD;  n  = 90), pure depression (MDD;  n  = 85), and non-anxious/non-depressed controls (HC;  n  = 93) were randomly assigned to conditions where they were asked to worry, ruminate, or relax. Emotional and physiological changes were measured during worry and subsequent exposure to fearful and sad videos. We also assessed participant group differences in preference for worry or rumination as a strategy to cope with negative affect during the negative emotional video exposures. Consistent with CAM, regardless of the group, both worry and rumination enabled avoidance of NEC. Whereas worry led to greater avoidance of a fear contrast, rumination led to greater avoidance of a sadness contrast. On the other hand, relaxation enhanced NEC. Skin conductance also indicated patterns in line with CAM. In the subjectively perceived preference, the GAD group reported a greater preference for worry in coping with a fear contrast than HC. However, such a salient pattern was not found for the MDD group. Treatment implications of these findings are discussed.",2022,"Whereas worry led to greater avoidance of a fear contrast, rumination led to greater avoidance of a sadness contrast.","['Individuals with self-reported symptoms of pure generalized anxiety disorder (GAD;  n  = 90), pure depression (MDD;  n  = 85), and non-anxious/non-depressed controls (HC;  n  = 93']",['negative emotional contrast from worry and rumination'],"['Emotional and physiological changes', 'preference for worry or rumination', 'Skin conductance', 'negative emotion']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",93.0,0.00889273,"Whereas worry led to greater avoidance of a fear contrast, rumination led to greater avoidance of a sadness contrast.","[{'ForeName': 'Hanjoo', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, University of Michigan, Michigan, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, Pennsylvania, USA.'}]",Journal of behavioral and cognitive therapy,['10.1016/j.jbct.2021.12.007']
1726,35693867,The Influence of Phototherapy on Recovery From Exercise-Induced Muscle Damage.,"Background


Intense physical activity can result in exercise-induced muscle damage, delayed-onset muscle soreness, and decrements in performance. Phototherapy (PhT), sometimes referred to as photobiomodulation or low-level laser therapy, may enhance recovery from vigorous exercise.
Purpose


The purpose of this study was to assess the influence of phototherapy on functional movements (vertical jump, agility), and perceptions of muscle soreness following exercise-induced muscle damage caused by high volume sprinting and decelerations.
Methods


In a between-group design, 33 participants performed 40x15m sprints, a protocol intended to cause muscle damage. Immediately following sprinting and in the four days following, vertical jump and agility were assessed, as well as calf, hamstring, quadriceps, and overall perceptions of soreness. Sixteen subjects (age 20.6±1.6 yrs; BMI 25.8±4.6 kg.m-2) received PhT prior to testing each day, while 17 (age 20.8±1.3 yrs; BMI 26.2±4.5 kg.m-2) received sham PhT and served as a control (CON). Measurements were recorded during five days of recovery from the repeated sprint protocol, then compared to those recorded during three baseline days of familiarization. Area under the curve was calculated by summing all five scores, and comparing those values by condition via a two-tailed unpaired t-test for normally distributed data, and a two-tailed Mann-Whitney U test for nonparametric data (alpha level = 0.05).
Results


Calf soreness was lower in PhT compared to CON ( p  = 0.02), but no other significant differences were observed between groups for vertical jump, agility, quadriceps, hamstring, and overall soreness ( p  > 0.05).
Discussion


Phototherapy may attenuate soreness in some muscle groups following exercise-induced muscle damage, but may not enhance recovery after explosive, short-duration activities.
Conclusion


Phototherapy may not be a useful recovery tool for those participating in explosive, short-duration activities.
Level of evidence


2c.",2022,"Calf soreness was lower in PhT compared to CON ( p  = 0.02), but no other significant differences were observed between groups for vertical jump, agility, quadriceps, hamstring, and overall soreness ( p  > 0.05).
","['Sixteen subjects (age 20.6±1.6 yrs; BMI 25.8±4.6 kg.m-2) received PhT prior to testing each day, while 17 (age 20.8±1.3 yrs; BMI 26.2±4.5 kg.m-2) received']","['phototherapy', 'sham PhT and served as a control (CON', 'Phototherapy (PhT), sometimes referred to as photobiomodulation or low-level laser therapy', 'Phototherapy']","['vertical jump, agility, quadriceps, hamstring, and overall soreness', 'Calf soreness', 'functional movements (vertical jump, agility), and perceptions of muscle soreness']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]",33.0,0.066878,"Calf soreness was lower in PhT compared to CON ( p  = 0.02), but no other significant differences were observed between groups for vertical jump, agility, quadriceps, hamstring, and overall soreness ( p  > 0.05).
","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': ""D'Amico"", 'Affiliation': 'Sport and Movement Science Department, Salem State University.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Silva', 'Affiliation': 'Sport and Movement Science Department, Salem State University.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Rubero', 'Affiliation': 'Sport and Movement Science Department, Salem State University.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Dion', 'Affiliation': 'Sport and Movement Science Department, Salem State University.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gillis', 'Affiliation': 'Sport and Movement Science Department, Salem State University.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gallo', 'Affiliation': 'Sport and Movement Science Department, Salem State University.'}]",International journal of sports physical therapy,['10.26603/001c.34422']
1727,35693853,"Effectiveness of Scapular Stabilization Versus Non-Stabilization Stretching on Shoulder Range of Motion, a Randomized Clinical Trial.","Background


Previous research has demonstrated the benefits of both stabilization and non-stabilization of the scapula during stretching in individuals with posterior shoulder tightness, but limited evidence exists in patients with shoulder pain.
Hypothesis/Purpose


The aim of this study was to determine the effect of stabilized scapular stretching on patients with shoulder pain. The primary hypothesis of this study is that stabilized scapular stretching will improve glenohumeral motion and pain compared to non-stabilized stretch program. A secondary hypothesis of this study is that stabilized scapular stretching will produce greater improvement in function compared to the non-stabilized stretching program.
Study Design


Randomized Clinical Trial.
Methods


Sixteen patients with sub-acromial pain associated with tendinopathy and associated pathologies presenting to physical therapy were randomized into two groups (stabilized or non-stabilized scapular stretching). Baseline pain and range of motion were measured prior to and following each treatment session for three visits that occurred over the course five to seventeen days depending on the patients availability. The dependent measurements were stabilized horizontal adduction, stabilized internal rotation, stabilized shoulder flexion, non-stabilized shoulder flexion, and current pain level.
Results


Patients in the scapular stabilization stretching group increased horizontal adduction 40° (CI 95  31, 48°) compared to the non-stabilization stretching group increase of 8° (CI 95  0, 17°) over the course of the three treatments ( p <0.001). Similarly, the stabilized stretching group increased internal rotation 48° (CI 95  26, 69°) compared to the non-stabilized stretching group increase of 26° (CI 95  4, 48°) ( p =0.001). Pain decreased in the stabilized stretching group by 1.4 points (CI 95  -0.4, 3.2) but increased slightly in non-stabilized group by -0.5 points (CI 95  -2.3, 1.3) which was not a clinically meaningful change. ( p =0.03).
Conclusion


Stabilized scapular stretching was more effective than non-stabilized stretching at gaining shoulder mobility in patients with shoulder pain. Benefits were immediate and sustained between treatment sessions. Stretching interventions improved range of motion but had limited effect on shoulder pain.
Level of Evidence


2.",2022,"Results


Patients in the scapular stabilization stretching group increased horizontal adduction 40° (CI 95  31, 48°) compared to the non-stabilization stretching group increase of 8° (CI 95  0, 17°) over the course of the three treatments ( p <0.001).","['patients with shoulder pain', 'Sixteen patients with sub-acromial pain associated with tendinopathy and associated pathologies presenting to physical therapy']","['stabilized scapular stretching', 'Scapular Stabilization Versus Non-Stabilization Stretching', 'stabilized or non-stabilized scapular stretching', 'stabilized stretching']","['horizontal adduction', 'internal rotation', 'shoulder pain', 'range of motion', 'stabilized horizontal adduction, stabilized internal rotation, stabilized shoulder flexion, non-stabilized shoulder flexion, and current pain level', 'Pain', 'glenohumeral motion and pain', 'Baseline pain and range of motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",16.0,0.141461,"Results


Patients in the scapular stabilization stretching group increased horizontal adduction 40° (CI 95  31, 48°) compared to the non-stabilization stretching group increase of 8° (CI 95  0, 17°) over the course of the three treatments ( p <0.001).","[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Howell', 'Affiliation': 'FYZICAL Therapy & Balance Centers.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Burchett', 'Affiliation': 'FYZICAL Therapy & Balance Centers.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heebner', 'Affiliation': 'Sports Medicine Research Institute, University of Kentucky.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Walker', 'Affiliation': 'Department of Athletic Training and Clinical Nutrition, University of Kentucky.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Baunach', 'Affiliation': 'Department of Physical Therapy, University of Kentucky.'}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Seidt', 'Affiliation': 'Department of Physical Therapy, University of Kentucky.'}, {'ForeName': 'Tim L', 'Initials': 'TL', 'LastName': 'Uhl', 'Affiliation': 'Department of Physical Therapy, University of Kentucky.'}]",International journal of sports physical therapy,[]
1728,35694051,Effect of Tele-Guided Imagery on Stress among Caregivers of Chronic Neurological Patients: A Randomized Controlled Trial.,"Background and Objectives   Chronic neurological conditions impose a burden on caregivers as they are a major contributor for disability-adjusted life years of patients. Stress is the common psychological concern of caregivers. This randomized controlled study examined the effect of tele-guided imagery on stress among caregivers of these neurological patients.  Methods   Thirty caregivers were selected for participation in study as per the inclusion criteria and were randomly assigned into experimental and control groups. Initial caregivers' mental health screening was performed with the mini-mental state examination tool. For outcome measure, perceived stress scale (PSS) score tool was utilized and both pre- and postintervention scores were noted. Effect of tele-guided intervention was compared with the control group.  Results   Significant difference was noted in the PSS scores among the caregivers receiving tele-guided imagery when compared with controlled group caregivers.  Conclusion   Tele-guided imagery is an effective tool for stress management among caregivers. Also, it improves the individual's mental health aspect.",2022,Significant difference was noted in the PSS scores among the caregivers receiving tele-guided imagery when compared with controlled group caregivers.  ,"['Caregivers of Chronic Neurological Patients', 'caregivers', 'Thirty caregivers were selected for participation in study as per the inclusion criteria', 'caregivers of these neurological patients']","['Tele-Guided Imagery', 'tele-guided intervention', 'tele-guided imagery']","['perceived stress scale (PSS) score tool was utilized and both pre- and postintervention scores', 'PSS scores']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4304048', 'cui_str': 'PSS (Perceived Stress Scale) score'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]",30.0,0.126841,Significant difference was noted in the PSS scores among the caregivers receiving tele-guided imagery when compared with controlled group caregivers.  ,"[{'ForeName': 'Minakshi', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Physiotherapy, Galgotias University, Greater Noida, Uttar Pradesh, India.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Chakraverty', 'Affiliation': 'Department of Physiotherapy, Galgotias University, Greater Noida, Uttar Pradesh, India.'}]",Journal of neurosciences in rural practice,['10.1055/s-0042-1744119']
1729,35694030,"Efficacy of Curcumin on Treating Cancer Anorexia-Cachexia Syndrome in Locally or Advanced Head and Neck Cancer: A Double-Blind, Placebo-Controlled Randomised Phase IIa Trial (CurChexia).","Background


Cancer anorexia-cachexia syndrome (CAS) is a significant comorbidity among all patients with cancer, increasing the mortality rate. Almost all patients with head and neck cancer experience this syndrome. CAS causes increased energy expenditure by increasing systemic inflammation and decreasing energy consumption due to anorexia. It leads to skeleton muscle breakdown and reduces the quality of life. Nutritional interventions and primary cancer treatment are the mainstays to manage this situation. However, a vicious cycle causes CAS to persist, especially in head and neck cancer, where tumour location and its treatment interfere with nutritional interventions. Curcumin shows anti-inflammatory effects, including modulated CAS in animal and in vitro studies.
Objective


The study aimed to determine the effect of curcumin to treat cancer anorexia-cachexia syndrome among current patients with locally advanced or advanced head and neck cancer.
Methods


This constitutes a randomised, double-blind, placebo-controlled phase IIa study. Twenty patients with CAS in locally advanced or advanced head and neck cancer adequately nourished via a feeding tube were enrolled and randomised in a 1 : 1 ratio to receive oral curcumin (at a dose of 4000 mg daily) ( n  = 10) or placebo ( n  = 10) for 8 weeks. The primary endpoint was body composition (muscle mass, body fat mass, and basal metabolic rate). The secondary endpoints were handgrip muscle strength, body mass index, absolute lymphocyte count, and safety and toxicity.
Result


There was a statistically significant benefit from curcumin on improving muscle mass compared with placebo (2.16% [95% confidence interval; CI, -0.75 to 5.07] vs. -3.82% [95% CI, -8.2 to 0.57];  P =0.019). The other parameters of body composition were not significant but tended to favour curcumin benefit. The body fat mass (-0.51 [95% CI, -21.89 to 20.86] vs. -8.97% [95% CI, -19.43 to 1.49];  P =0.432) and percentage of mean change in the basal metabolic rate were noted (BMR) (0.54% [95% CI, -1.6 to 2.67] vs. -1.61% [95% CI, -4.05 to 0.84];  P =0.153). Notably, patients treated with curcumin exhibited less reduction in handgrip muscle strength and absolute lymphocyte count but was not significant. Similarly, most adverse events were grade 1 in both groups.
Conclusion


The curcumin add-on resulted in a significant increase in muscle mass than standard nutritional support. Furthermore, it may improve and delay a decrease in the other body composition parameters, handgrip strength, and absolute lymphocyte count. Curcumin was safe and well tolerated. This constitutes an unmet need for clinical trials. This trial is registered with NCT04208334.",2022,"Notably, patients treated with curcumin exhibited less reduction in handgrip muscle strength and absolute lymphocyte count but was not significant.","['Cancer Anorexia-Cachexia Syndrome in Locally or Advanced Head and Neck Cancer', 'Twenty patients with CAS in locally advanced or advanced head and neck cancer adequately nourished via a feeding tube', 'patients with head and neck cancer experience this syndrome', '\n\n\nCancer anorexia-cachexia syndrome (CAS', 'current patients with locally advanced or advanced head and neck cancer']","['curcumin', 'Curcumin', 'CAS', 'oral curcumin', 'placebo', 'Placebo']","['cancer anorexia-cachexia syndrome', 'body fat mass', 'handgrip muscle strength and absolute lymphocyte count', 'muscle mass', 'body composition', 'quality of life', 'improving muscle mass', 'body composition (muscle mass, body fat mass, and basal metabolic rate', 'basal metabolic rate', 'body composition parameters, handgrip strength, and absolute lymphocyte count', 'mortality rate', 'safe and well tolerated', 'handgrip muscle strength, body mass index, absolute lymphocyte count, and safety and toxicity']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",20.0,0.465033,"Notably, patients treated with curcumin exhibited less reduction in handgrip muscle strength and absolute lymphocyte count but was not significant.","[{'ForeName': 'Tawasapon', 'Initials': 'T', 'LastName': 'Thambamroong', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Kasan', 'Initials': 'K', 'LastName': 'Seetalarom', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Siriwimon', 'Initials': 'S', 'LastName': 'Saichaemchan', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Yanisa', 'Initials': 'Y', 'LastName': 'Pumsutas', 'Affiliation': 'Division of Clinical Nutrition, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Naiyarat', 'Initials': 'N', 'LastName': 'Prasongsook', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}]",Journal of nutrition and metabolism,['10.1155/2022/5425619']
1730,35693986,Effective interventions on health effects of Chinese rural elderly under heat exposure.,"Due to climate change, the heatwave has become a more serious public health threat with aging as an aggravating factor in recent years. There is a pressing need to detect the most effective prevention and response measures. However, the specific health effects of interventions have not been characterized on an individual scale. In this study, an intervention experiment was designed to explore the health effects of heat exposure at the individual level and assess the effects of different interventions based on a comprehensive health sensitivity index (CHSI) in Xinyi, China. Forty-one subjects were recruited randomly, and divided into one control group and three intervention groups. Interventions included education (Educate by lecturing, offering relative materials, and communication), subsidy support (offer subsidy to offset the cost of running air conditioning), and cooling-spray (install a piece of cooling-spray equipment in the yard). Results showed that systolic blood pressure (SBP) and deep sleep duration (DSD) were significantly affected by short-term heat exposure, and the effects could be alleviated by three types of interventions. The estimated CHSI indicated that the effective days of the education group were longer than other groups, while the lower CHSI of the subsidy group showed lower sensitivity than the control group. These findings provide feasible implementation strategies to optimize Heat-health action plans and evaluate the intervention performance.
Electronic Supplementary Material


Supplementary material is available in the online version of this article at 10.1007/s11783-022-1545-4 and is accessible for authorized users.",2022,"Due to climate change, the heatwave has become a more serious public health threat with aging as an aggravating factor in recent years.","['Forty-one subjects', 'Chinese rural elderly under heat exposure']","['education (Educate by lecturing, offering relative materials, and communication), subsidy support (offer subsidy to offset the cost of running air conditioning), and cooling-spray (install a piece of cooling-spray equipment in the yard']","['lower sensitivity', 'systolic blood pressure (SBP) and deep sleep duration (DSD', 'health effects']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0239930', 'cui_str': 'Heat exposure'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001864', 'cui_str': 'Air Conditioning'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439205', 'cui_str': 'yd'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",41.0,0.00758887,"Due to climate change, the heatwave has become a more serious public health threat with aging as an aggravating factor in recent years.","[{'ForeName': 'Yujia', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Pollution Control and Resource Reuse, School of the Environment, Nanjing University, Nanjing, 210023 China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Pollution Control and Resource Reuse, School of the Environment, Nanjing University, Nanjing, 210023 China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Lou', 'Affiliation': 'State Key Laboratory of Pollution Control and Resource Reuse, School of the Environment, Nanjing University, Nanjing, 210023 China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Faculty of Civil Engineering and Mechanics, Jiangsu University, Zhenjiang, 212013 China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Pollution Control and Resource Reuse, School of the Environment, Nanjing University, Nanjing, 210023 China.'}]",Frontiers of environmental science & engineering,['10.1007/s11783-022-1545-4']
1731,35693983,Effectiveness and Safety of Levothyroxine Tablets Combined with Iodine-131 in the Treatment of Thyroid Cancer.,"Objective


To explore the effectiveness of levothyroxine tablets combined with iodine-131 in thyroid cancer patients after radical thyroidectomy and the effect on their serum thyroglobulin (Tg) and thyroglobulin antibody (TgAb) levels.
Methods


A total of 70 thyroid cancer patients receiving radical thyroidectomy in our hospital from July 2015 to April 2016 were recruited and were assigned via different treatment methods (1 : 1) to receive either levothyroxine tablets (observation group) or levothyroxine tablets plus iodine-131 (control group). Outcome measures included treatment efficiency, 1, 3, and 5-year recurrence and metastasis, serum Tg and TgAb levels, postoperative survival, and adverse reactions.
Results


The total effective rate of treatment in the control group was significantly higher than that in the observation group ( P  < 0.05). There was no significant difference in cancer recurrence and metastasis rate between the two groups one year postoperatively ( P  > 0.05). The rate of cancer recurrence and metastasis in the control group was significantly lower than that in the observation group 3 and 5 years after surgery ( P  < 0.05). Before treatment, there was no significant difference in serum Tg and TgAb levels between the two groups ( P  > 0.05). After treatment, serum Tg and TgAb levels decreased in both groups, with lower results in the control group ( P  < 0.05). There was no significant difference in the 1 and 3-year survival rates between the two groups ( P  > 0.05). The 5-year survival rate in the control group was significantly higher than that in the observation group ( P  < 0.05). There was no significant difference in adverse reactions between the two groups ( P  > 0.05).
Conclusion


Levothyroxine tablets combined with iodine-131 for thyroid cancer patients undergoing radical thyroidectomy effectively could improve the treatment efficiency, reduce the risk of cancer recurrence and metastasis after surgery, lower the serum Tg and TgAb levels of patients, and prolong the survival of patients, with a high safety profile. Further trials are, however, required prior to clinical promotion.",2022,The rate of cancer recurrence and metastasis in the control group was significantly lower than that in the observation group 3 and 5 years after surgery ( P  < 0.05).,"['thyroid cancer patients undergoing', '70 thyroid cancer patients receiving', 'in our hospital from July 2015 to April 2016', 'Thyroid Cancer', 'thyroid cancer patients after radical thyroidectomy']","['radical thyroidectomy', 'Levothyroxine Tablets Combined with Iodine-131', 'Levothyroxine tablets combined with iodine-131', 'levothyroxine tablets combined with iodine-131', 'levothyroxine tablets (observation group) or levothyroxine tablets plus iodine-131 (control group']","['total effective rate', 'Effectiveness and Safety', '3-year survival rates', 'serum thyroglobulin (Tg) and thyroglobulin antibody (TgAb) levels', 'risk of cancer recurrence and metastasis', 'treatment efficiency, 1, 3, and 5-year recurrence and metastasis, serum Tg and TgAb levels, postoperative survival, and adverse reactions', 'serum Tg and TgAb levels', 'rate of cancer recurrence and metastasis', 'adverse reactions', '5-year survival rate', 'cancer recurrence and metastasis rate']","[{'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0303029', 'cui_str': 'iodine I-131'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040123', 'cui_str': 'Thyroglobulin'}, {'cui': 'C0201512', 'cui_str': 'Thyroglobulin antibody measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",70.0,0.11086,The rate of cancer recurrence and metastasis in the control group was significantly lower than that in the observation group 3 and 5 years after surgery ( P  < 0.05).,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Fourth Department of Thyroid Mammary, Cangzhou Central Hospital, 16 Xinhua West Road, Cangzhou, Hebei, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Fourth Department of Thyroid Mammary, Cangzhou Central Hospital, 16 Xinhua West Road, Cangzhou, Hebei, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Fourth Department of Thyroid Mammary, Cangzhou Central Hospital, 16 Xinhua West Road, Cangzhou, Hebei, China.'}, {'ForeName': 'Buyong', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Fourth Department of Thyroid Mammary, Cangzhou Central Hospital, 16 Xinhua West Road, Cangzhou, Hebei, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Fourth Department of Thyroid Mammary, Cangzhou Central Hospital, 16 Xinhua West Road, Cangzhou, Hebei, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Fourth Department of Thyroid Mammary, Cangzhou Central Hospital, 16 Xinhua West Road, Cangzhou, Hebei, China.'}]",Journal of oncology,['10.1155/2022/3676886']
1732,35698203,Efficacy of dexmedetomidine on postoperative pain in patients undergoing gastric and esophageal endoscopic submucosal dissection: a study protocol for a randomized controlled prospective trial.,"BACKGROUND


Endoscopic submucosal dissection (ESD) is widely used as an effective treatment of early gastric and esophageal tumors, as it is minimally invasive, safe, and convenient. Epigastric pain is a common complication of ESD. In the traditional cognition, the postoperative pain of ESD is not serious and does not attach too much attention. However, previous studies found that the incidence of moderate to severe pain after ESD can be as high as 44.9~62.8%. At present, there is no unified understanding of how to carry out good postoperative analgesia in patients undergoing ESD of stomach and esophagus. The purpose of present study is to investigate the efficacy of intraoperative dexmedetomidine (DEX) using on postoperative pain though observing the postoperative visual analog scale (VAS) score within 48 h after ESD surgery, so as to explore an effective analgesia and anesthetic method in patients undergoing gastric and esophagus ESD.
METHODS/DESIGN


This study is a prospective, single-center, two-arm, randomized control trail. In total, 120 patients undergoing endoscopic submucosal dissection were stratified by type of surgery (i.e., gastric or esophagus ESD) and randomized into two treatment groups, DEX group (group D, n = 60) and control group (group C, n = 60). Patients in the experimental group (DEX group) will be administrated a loading dose of DEX at 1 μg/kg for 15 min and a continuous infusion at 0.6 μg/kg/h until 30 min before the end of operation. In control group, the same volume of normal saline was infused. The primary outcome is VAS at 2 h after ESD surgery. The secondary outcome will be VAS at 1 h, 4 h, 6 h,18 h, 24 h, and 48 h, the status of perioperative hemodynamics, the use of remedial analgesics, sedation score, shivering, postoperative nausea and vomiting (PONV), and satisfaction scores of patient and complication of ESD (such as bleeding, perforation, aspiration pneumonia).
DISCUSSION


The results of this study will demonstrate that intraoperative application of DEX is beneficial for postoperative pain treatment in patients undergoing ESD. This study will not only confirm that postoperative pain treatment is necessary for patients undergoing ESD but also provides an effective anesthesia method for postoperative analgesia.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ID: ChiCTR2100043837 , registered on March 4, 2021, http://www.chictr.org.cn .",2022,"In total, 120 patients undergoing endoscopic submucosal dissection were stratified by type of surgery (i.e., gastric or esophagus ESD) and randomized into two treatment groups, DEX group (group D, n = 60) and control group (group C, n = 60).","['patients undergoing ESD', 'patients undergoing gastric and esophagus ESD', 'patients undergoing gastric and esophageal endoscopic submucosal dissection', 'patients undergoing ESD of stomach and esophagus', '120 patients undergoing endoscopic submucosal dissection were stratified by type of surgery (i.e., gastric or esophagus ESD']","['DEX', 'intraoperative dexmedetomidine (DEX', 'dexmedetomidine', 'Endoscopic submucosal dissection (ESD']","['VAS at 2\u2009h after ESD surgery', 'postoperative pain', 'postoperative visual analog scale (VAS) score', 'Epigastric pain', 'VAS at 1\u2009h, 4\u2009h, 6\u2009h,18\u2009h, 24\u2009h, and 48\u2009h, the status of perioperative hemodynamics, the use of remedial analgesics, sedation score, shivering, postoperative nausea and vomiting (PONV), and satisfaction scores of patient and complication of ESD (such as bleeding, perforation, aspiration pneumonia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}]",120.0,0.134795,"In total, 120 patients undergoing endoscopic submucosal dissection were stratified by type of surgery (i.e., gastric or esophagus ESD) and randomized into two treatment groups, DEX group (group D, n = 60) and control group (group C, n = 60).","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.'}, {'ForeName': 'Li-Xin', 'Initials': 'LX', 'LastName': 'An', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China. anlixin8120@163.com.'}, {'ForeName': 'Pei-Shan', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China.'}, {'ForeName': 'Xin-Lu', 'Initials': 'XL', 'LastName': 'Chang', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China.'}]",Trials,['10.1186/s13063-022-06432-4']
1733,35698194,Novel computer-aided reconstruction of soft tissue defects following resection of oral and oropharyngeal squamous cell carcinoma.,"BACKGROUND


Reconstruction of soft tissue defects following surgical tumor resection is important for quality of life in cancer patients with oral and oropharyngeal squamous cell carcinoma (SCC). This study presents a novel computer-aided reconstruction of soft tissue (CARST) technology employed with these patients.
METHODS


We first described the CARST technology in detail in a report of a 34-year-old male patient with locally invasive right-sided tongue SCC following a nearly total glossectomy and reported the postoperative outcomes. This digital technology was applied to construct a 3D model from CT images, which was used to delineate surgical resection boundaries and design a personalized reconstruction of the soft tissue defect. A nonuniform rational B-spline (NURBS) was generated and applied to transform the 3D model into a 2D flap-cutting guide printed out using a 3D printer. We then reported a case-series study on oral and oropharyngeal SCC patients who were randomly assigned to receive the CARST (n = 15) or a traditional soft tissue reconstruction (n = 15). Clinicopathological features and short- and long-term postoperative outcomes between the two groups were compared.
RESULTS


The patient with the tongue SCC had a successful CARST following surgical tumor resection without any complications. His speech and swallowing functions recovered well after surgery and he experienced no significant changes to his appearance following recovery. There was no recurrence within a 3-year follow-up period. Results of the case-series study showed that the CARST group had significantly shorter operative and post-operation hospital-stay time, a higher flap utilization rate, and a trend of less and milder postoperative complications, and they experienced no significant difference in intraoperative blood loss and long-term outcomes compared to the traditional group.
CONCLUSION


CARST is a safer and more efficient personalized technology of soft tissue reconstruction following surgical tumor resection in patients with oral and oropharyngeal SCC.",2022,"CONCLUSION


CARST is a safer and more efficient personalized technology of soft tissue reconstruction following surgical tumor resection in patients with oral and oropharyngeal SCC.","['resection of oral and oropharyngeal squamous cell carcinoma', 'oropharyngeal SCC patients', 'cancer patients with oral and oropharyngeal squamous cell carcinoma (SCC', '34-year-old male patient with locally invasive right-sided tongue SCC', 'patients with oral and oropharyngeal SCC']","['novel computer-aided reconstruction of\xa0soft tissue (CARST) technology', 'Novel computer-aided reconstruction', 'surgical tumor resection', 'CARST', 'traditional soft tissue reconstruction']","['shorter operative and post-operation hospital-stay time, a higher flap utilization rate', 'His speech and swallowing functions', 'Clinicopathological features and short- and long-term postoperative outcomes', 'milder postoperative complications', 'intraoperative blood loss']","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0349566', 'cui_str': 'Squamous cell carcinoma of tongue'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",15.0,0.0330398,"CONCLUSION


CARST is a safer and more efficient personalized technology of soft tissue reconstruction following surgical tumor resection in patients with oral and oropharyngeal SCC.","[{'ForeName': 'Jiajie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Otolaryngology& Head and Neck Center, Cancer Center, Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), 310014, Hangzhou, China.""}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Lai', 'Affiliation': ""Center for Plastic & Reconstructive Surgery, Department of Plastic & Reconstructive Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), 310014, Hangzhou, China.""}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of E&M, Zhejiang University of Technology, Ministry of Education & Zhejiang Province, Hangzhou, 310014, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Otolaryngology& Head and Neck Center, Cancer Center, Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), 310014, Hangzhou, China.""}, {'ForeName': 'Chuanming', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ""Otolaryngology& Head and Neck Center, Cancer Center, Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), 310014, Hangzhou, China.""}, {'ForeName': 'Jiafeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Otolaryngology& Head and Neck Center, Cancer Center, Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), 310014, Hangzhou, China.""}, {'ForeName': 'Haiwei', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': ""Otolaryngology& Head and Neck Center, Cancer Center, Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), 310014, Hangzhou, China.""}, {'ForeName': 'Liehao', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': ""Otolaryngology& Head and Neck Center, Cancer Center, Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), 310014, Hangzhou, China.""}, {'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Ge', 'Affiliation': 'College of Letters and Science, University of California, Los Angeles, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Xiabin', 'Initials': 'X', 'LastName': 'Lan', 'Affiliation': 'Department of Head and Neck Surgery, Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Surgery, Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Minghua', 'Initials': 'M', 'LastName': 'Ge', 'Affiliation': ""Otolaryngology& Head and Neck Center, Cancer Center, Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), 310014, Hangzhou, China. minghuage.zjph@gmail.com.""}]",World journal of surgical oncology,['10.1186/s12957-022-02654-7']
1734,35698187,"Effect of post-isometric relaxation versus myofascial release therapy on pain, functional disability, rom and qol in the management of non-specific neck pain: a randomized controlled trial.","BACKGROUND


Non-specific neck pain is the most prevailing musculoskeletal disorder which has a large socioeconomic burden worldwide. It is associated with poor posture and neck strain which may lead to pain and restricted mobility. Physical therapists treat such patients through several means. Post isometric relaxation and Myofascial release therapy are used in clinical practice with little evidence to be firmed appropriately. So, this study was conducted to explore the effect of Post-isometric relaxation in comparison to Myofascial release therapy for patients having non-specific neck pain.
METHODOLOGY


Sixty patients were randomly allocated to Post isometric group and the Myofascial group. The treatment period was of 2 weeks. All the patients were evaluated using the Visual analogue scale (VAS), Neck disability index (NDI), Universal Goniometer, and WHO BREF Quality of life-100 in the 1st and 6th sessions. Recorded data was entered on SPSS 21. Data were examined using two-way repeated ANOVA to measure the variance of analysis (group x time).
RESULTS


Analysis of the baseline characteristics revealed that both groups were homogenous in terms of age and gender i.e. a total of 60 participants were included in this research study 30 in each group. Out of 60 patients, there were 20(33.3%) males and 40(66.7%) females with a mean age of 32.4(5.0) years. Participants in the Post Isometric group demonstrated significant improvements (p < 0.025) in VAS, NDI, Cervical Extension, left side rotation ranges, and QoL (Social Domain) at the 2-week follow-up compared with those in the Myofascial group. In addition, the Myofascial group indicated significantly better improvement in the mean score of CROM (flexion and right and left side bending).
CONCLUSION


The study demonstrated patients with nonspecific neck pain can benefit from the post isometric relaxation with significant improvement in pain, disability, cervical ROM, and Quality of life compared with myofascial release therapy.
TRIAL REGISTRATION


Clinical Trial registered on clinicaltrial.gov (NCT number) NCT04638062 , 20/11/2020 (prospectively registered).",2022,"Participants in the Post Isometric group demonstrated significant improvements (p < 0.025) in VAS, NDI, Cervical Extension, left side rotation ranges, and QoL (Social Domain) at the 2-week follow-up compared with those in the Myofascial group.","['non-specific neck pain', 'Out of 60 patients, there were 20(33.3%) males and 40(66.7%) females with a mean age of 32.4(5.0) years', 'patients with nonspecific neck pain', 'Sixty patients', 'patients having non-specific neck pain']","['Post-isometric relaxation', 'post-isometric relaxation versus myofascial release therapy']","['pain, disability, cervical ROM, and Quality of life', 'pain, functional disability, rom and qol', 'VAS, NDI, Cervical Extension, left side rotation ranges, and QoL (Social Domain', 'mean score of CROM (flexion and right and left side bending', 'Visual analogue scale (VAS), Neck disability index (NDI), Universal Goniometer, and WHO BREF Quality of life-100']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1292305', 'cui_str': 'Cromer blood group system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C1704407', 'cui_str': '100'}]",60.0,0.0216657,"Participants in the Post Isometric group demonstrated significant improvements (p < 0.025) in VAS, NDI, Cervical Extension, left side rotation ranges, and QoL (Social Domain) at the 2-week follow-up compared with those in the Myofascial group.","[{'ForeName': 'Zainab Khalid', 'Initials': 'ZK', 'LastName': 'Khan', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences, Karachi, Pakistan. zainab.khalid336@gmail.com.'}, {'ForeName': 'Syed Imran', 'Initials': 'SI', 'LastName': 'Ahmed', 'Affiliation': 'Sindh Physical Medicine and Rehabilitation, Karachi, Pakistan.'}, {'ForeName': 'Aftab Ahmed Mirza', 'Initials': 'AAM', 'LastName': 'Baig', 'Affiliation': 'Sindh Physical Medicine and Rehabilitation, Karachi, Pakistan.'}, {'ForeName': 'Waqas Ahmed', 'Initials': 'WA', 'LastName': 'Farooqui', 'Affiliation': 'School of Public Health, Dow University of Health Sciences, Karachi, Pakistan.'}]",BMC musculoskeletal disorders,['10.1186/s12891-022-05516-1']
1735,35698165,Effectiveness and mechanism of a 4-week online self-help mindfulness intervention among individuals with emotional distress during COVID-19 in China.,"BACKGROUND


Many people suffered from emotional distress especially during the COVID-19 pandemic. In order to alleviate emotional distress, more accessible psychological intervention programs, such as online intervention programs, are needed. The study aimed to investigate the efficacy and the potential mechanism of a 4-week, online, self-help mindfulness-based intervention to manage emotional distress during the COVID-19 pandemic between February 3 and May 20, 2020.
METHODS


A total of 302 individuals with high emotional distress completed a self-help mindfulness course, which lasted 30-60 min per day for 28 consecutive days. Participants who registered in the program later were included in the analyses as the control group (n = 315). Levels of mindfulness, perceived stress, emotional distress, anxiety and depression were assessed at baseline(T1), week 1(T2), week 2(T3), week 3(T4) and week 4(T5).
RESULTS


Significant Group by Time interaction effects were found on mindfulness, perceived stress, emotional distress, anxiety and depression (p < 0.001). Compared to the control group, the intervention group had a greater increase in changes of all outcome variables (p < 0.001). Random intercept cross-lagged analyses showed that compared with control group, mindfulness at T2 and T4 negatively predicted stress at T3 and T5, and mindfulness at T2 and T4 negatively predicted depression at T3 and T5 while depression at T3 predicted mindfulness at T4 in the mindfulness group.
CONCLUSIONS


The results suggest that a 4-week self-help online mindfulness intervention improved mindfulness and reduced stress, emotional distress, anxiety and depression symptoms. Compared to the control group, changes in mindfulness preceded changes in stress, and mindfulness and depression reciprocally influenced each other during the intervention. Trial registration Chinese Clinical Trial Registry: ChiCTR2000034539. Registered 9 July 2020-Retrospectively registered, http://www.chictr.org.cn/edit.aspx?pid=55721&htm=4 .",2022,"Compared to the control group, the intervention group had a greater increase in changes of all outcome variables (p < 0.001).","['individuals with emotional distress during COVID-19 in China', '302 individuals with high emotional distress', 'Participants who registered in the program later were included in the analyses as the control group (n\u2009=\u2009315']","['online, self-help mindfulness-based intervention', '4-week online self-help mindfulness intervention']","['stress, and mindfulness and depression', 'Time interaction effects', 'Levels of mindfulness, perceived stress, emotional distress, anxiety and depression', 'mindfulness, perceived stress, emotional distress, anxiety and depression', 'mindfulness and reduced stress, emotional distress, anxiety and depression symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",302.0,0.134469,"Compared to the control group, the intervention group had a greater increase in changes of all outcome variables (p < 0.001).","[{'ForeName': 'Ruilin', 'Initials': 'R', 'LastName': 'Ju', 'Affiliation': ""Beijing Key Laboratory of Behavior and Mental Health, School of Psychological and Cognitive Sciences, Peking University, No. 5 Yiheyuan Road Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Wingsze', 'Initials': 'W', 'LastName': 'Chiu', 'Affiliation': ""Beijing Key Laboratory of Behavior and Mental Health, School of Psychological and Cognitive Sciences, Peking University, No. 5 Yiheyuan Road Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': ""Beijing Key Laboratory of Behavior and Mental Health, School of Psychological and Cognitive Sciences, Peking University, No. 5 Yiheyuan Road Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Stefan G', 'Initials': 'SG', 'LastName': 'Hofmann', 'Affiliation': 'Department of Clinical Psychology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Xinghua', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Beijing Key Laboratory of Behavior and Mental Health, School of Psychological and Cognitive Sciences, Peking University, No. 5 Yiheyuan Road Haidian District, Beijing, People's Republic of China. xinghua_liu@pku.edu.cn.""}]",BMC psychology,['10.1186/s40359-022-00831-7']
1736,35698162,Evaluating the effectiveness of stepwise swallowing training on dysphagia in patients with Alzheimer's disease: study protocol for a randomized controlled trial.,"BACKGROUND


The high prevalence of dysphagia among Alzheimer's disease (AD) patients has become a public health and economic concern. Therefore, effective and accessible dysphagia treatments are needed. As a fundamental rehabilitation of dysphagia, swallowing muscle exercises have received increased attention. Stepwise swallowing training (SST), integrated with all swallowing organs movement, is expected to improve swallowing dysfunction among AD patients. By using a randomized controlled trial design, we propose a multi-center research to evaluate the effectiveness of SST program among AD patients.
METHODS


A multi-center exploratory randomized controlled trial, with a 4-week follow-up period, will be conducted in three major public psychiatric hospitals in Guangdong, China. Participants in the control group will be assigned to routine dysphagia care, while participants in the intervention group will undergo the same nursing care and additionally receive the SST program. The SST program includes five sections of swallowing organs training: lip movement, facial movement, tongue movement, mandibular movement, and neck movement. Primary outcomes evaluate the swallowing function, namely, Water Swallowing Test (WTS) and Standard Swallowing Assessment (SSA). Secondary outcomes aim at measuring the improvement of negative impacts of dysphagia, namely eating behavior, ability of daily activity, and nutritional status. Data will be collected at baseline (T 1 ), at 2 weeks (T 2 , intervention), and 4 weeks after intervention (T 3 , follow-up).
DISCUSSION


This study will offer trial-based evidence of the effectiveness of SST in relieving dysphagia among AD patients. SST program is expected to improve both the swallowing function and reduce the negative impacts of dysphagia, with an exploration of acceptability in the SST program.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR2200056481 . Prospectively registered on 6 February 2022.",2022,"Stepwise swallowing training (SST), integrated with all swallowing organs movement, is expected to improve swallowing dysfunction among AD patients.","['AD patients', ""patients with Alzheimer's disease"", 'three major public psychiatric hospitals in Guangdong, China', 'Prospectively registered on 6 February 2022', ""Alzheimer's disease""]","['SST program', 'stepwise swallowing training', 'SST', 'routine dysphagia care, while participants in the intervention group will undergo the same nursing care and additionally receive the SST program', 'Stepwise swallowing training (SST), integrated with all swallowing organs movement']","['facial movement, tongue movement, mandibular movement, and neck movement', 'swallowing dysfunction', 'improvement of negative impacts of dysphagia, namely eating behavior, ability of daily activity, and nutritional status', 'swallowing function, namely, Water Swallowing Test (WTS) and Standard Swallowing Assessment (SSA']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0426982', 'cui_str': 'Motor function of tongue'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1286126', 'cui_str': 'Movement of neck'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.307568,"Stepwise swallowing training (SST), integrated with all swallowing organs movement, is expected to improve swallowing dysfunction among AD patients.","[{'ForeName': 'Chenxin', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Geriatric Psychiatry Department, Affiliated Brain Hospital of Guangzhou Medical University, 36 MingXin Road, Liwan Distrist, Guangzhou, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health and Management, Guangzhou University of Chinese Medicine, 12 Airport Road, Baiyun District, Guangzhou, China.'}, {'ForeName': 'Junrong', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Geriatric Psychiatry Department, Affiliated Brain Hospital of Guangzhou Medical University, 36 MingXin Road, Liwan Distrist, Guangzhou, China.'}, {'ForeName': 'Xingxiao', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Geriatric Psychiatry Department, Affiliated Brain Hospital of Guangzhou Medical University, 36 MingXin Road, Liwan Distrist, Guangzhou, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Geriatric Psychiatry Department, Affiliated Brain Hospital of Guangzhou Medical University, 36 MingXin Road, Liwan Distrist, Guangzhou, China.'}, {'ForeName': 'Lexin', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Geriatric Psychiatry Department, Affiliated Brain Hospital of Guangzhou Medical University, 36 MingXin Road, Liwan Distrist, Guangzhou, China.'}, {'ForeName': 'Haoyun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Nursing School, Guangzhou Medical University, 195 Dongfeng West Road, Yuexiu District, Guangzhou, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Nursing School, Guangzhou Medical University, 195 Dongfeng West Road, Yuexiu District, Guangzhou, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Geriatric Psychiatry Department, Affiliated Brain Hospital of Guangzhou Medical University, 36 MingXin Road, Liwan Distrist, Guangzhou, China.'}, {'ForeName': 'Jianxiong', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Psychiatry Department, Affiliated Brain Hospital of Guangzhou Medical University, 36 MingXin Road, Liwan Distrist, Guangzhou, China. jxguonet01@126.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'TCM Department, Affiliated Brain Hospital of Guangzhou Medical University, 36 MingXin Road, Liwan Distrist, Guangzhou, China. yulinfimmu@126.com.'}, {'ForeName': 'Aixiang', 'Initials': 'A', 'LastName': 'Xiao', 'Affiliation': 'Geriatric Psychiatry Department, Affiliated Brain Hospital of Guangzhou Medical University, 36 MingXin Road, Liwan Distrist, Guangzhou, China. 543061910@qq.com.'}]",Trials,['10.1186/s13063-022-06446-y']
1737,35698158,"TB-PRACTECAL: study protocol for a randomised, controlled, open-label, phase II-III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis.","BACKGROUND


Globally rifampicin-resistant tuberculosis disease affects around 460,000 people each year. Currently recommended regimens are 9-24 months duration, have poor efficacy and carry significant toxicity. A shorter, less toxic and more efficacious regimen would improve outcomes for people with rifampicin-resistant tuberculosis.
METHODS


TB-PRACTECAL is an open-label, randomised, controlled, phase II/III non-inferiority trial evaluating the safety and efficacy of 24-week regimens containing bedaquiline and pretomanid to treat rifampicin-resistant tuberculosis. Conducted in Uzbekistan, South Africa and Belarus, patients aged 15 and above with rifampicin-resistant pulmonary tuberculosis and requiring a new course of therapy were eligible for inclusion irrespective of HIV status. In the first stage, equivalent to a phase IIB trial, patients were randomly assigned one of four regimens, stratified by site. Investigational regimens include oral bedaquiline, pretomanid and linezolid. Additionally, two of the regimens also included moxifloxacin (arm 1) and clofazimine (arm 2) respectively. Treatment was administered under direct observation for 24 weeks in investigational arms and 36 to 96 weeks in the standard of care arm. The second stage of the study was equivalent to a phase III trial, investigating the safety and efficacy of the most promising regimen/s. The primary outcome was the percentage of unfavourable outcomes at 72 weeks post-randomisation. This was a composite of early treatment discontinuation, treatment failure, recurrence, lost-to-follow-up and death. The study is being conducted in accordance with ICH-GCP and full ethical approval was obtained from Médecins sans Frontières ethical review board, London School of Hygiene and Tropical Medicine ethical review board as well as ERBs and regulatory authorities at each site.
DISCUSSION


TB-PRACTECAL is an ambitious trial using adaptive design to accelerate regimen assessment and bring novel treatments that are effective and safe to patients quicker. The trial took a patient-centred approach, adapting to best practice guidelines throughout recruitment. The implementation faced significant challenges from the COVID-19 pandemic. The trial was terminated early for efficacy on the advice of the DSMB and will report on data collected up to the end of recruitment and, additionally, the planned final analysis at 72 weeks after the end of recruitment.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02589782. Registered on 28 October 2015.",2022,"This was a composite of early treatment discontinuation, treatment failure, recurrence, lost-to-follow-up and death.","['adult patients with pulmonary multidrug-resistant tuberculosis', 'Conducted in Uzbekistan, South Africa and Belarus, patients aged 15 and above with rifampicin-resistant pulmonary tuberculosis and requiring a new course of therapy were eligible for inclusion irrespective of HIV status']","['moxifloxacin', 'bedaquiline and pretomanid to treat rifampicin-resistant tuberculosis', 'clofazimine', 'linezolid', 'bedaquiline and pretomanid']","['percentage of unfavourable outcomes', 'safety and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0206526', 'cui_str': 'Multidrug resistant tuberculosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0042177', 'cui_str': 'Uzbekistan'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0006539', 'cui_str': 'Belorussia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1664205', 'cui_str': 'bedaquiline'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1532782', 'cui_str': 'Rifampicin resistant tuberculosis'}, {'cui': 'C0008996', 'cui_str': 'Clofazimine'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.387203,"This was a composite of early treatment discontinuation, treatment failure, recurrence, lost-to-follow-up and death.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Médecins sans Frontières, 10 Furnival Street, London, EC4A1AB, UK. Catherine.berry@london.msf.org.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'du Cros', 'Affiliation': 'Médecins sans Frontières, 10 Furnival Street, London, EC4A1AB, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fielding', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Gajewski', 'Affiliation': 'Swiss Tropical and Public Health Institute (affiliated with University of Basel), Kreuzstrasse 2, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Kazounis', 'Affiliation': 'Médecins sans Frontières, 10 Furnival Street, London, EC4A1AB, UK.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'McHugh', 'Affiliation': 'UCL Centre for Clinical Microbiology, Royal Free Campus, UCL, Rowland Hill Street, NW3 2PF, London, UK.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Merle', 'Affiliation': 'The Special Programme for Research & Training in Tropical Diseases (TDR) World Health Organization, Avenue Appia 20, 1211, 27, Geneva, Switzerland.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Motta', 'Affiliation': 'Médecins sans Frontières, 10 Furnival Street, London, EC4A1AB, UK.'}, {'ForeName': 'David A J', 'Initials': 'DAJ', 'LastName': 'Moore', 'Affiliation': 'TB Centre, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK.'}, {'ForeName': 'Bern-Thomas', 'Initials': 'BT', 'LastName': ""Nyang'wa"", 'Affiliation': 'Médecins sans Frontières, Plantage Middenlaan 14, 1018, DD, Amsterdam, The Netherlands.'}]",Trials,['10.1186/s13063-022-06331-8']
1738,35698156,Effect of smartphone app-based health care intervention for health management of high-risk mothers: a study protocol for a randomized controlled trial.,"BACKGROUND


The 4th Industrial Revolution with the advent of the smart era, in which artificial intelligence, such as big data analysis and machine learning, is expected, and the provision of healthcare services using smartphones has become a reality. In particular, high-risk mothers who experience gestational diabetes, gestational hypertension, and prenatal and postpartum depression are highly likely to have adverse effects on the mother and newborn due to the disease. Therefore, continuous observation and intervention in health management are needed to prevent diseases and promote healthy behavior for a healthy life.
METHODS


This randomized controlled trial will provide mothers 18 years of age or older with health care information collected based on evidence-based literature data using a smartphone app for 6 weeks. About 500 mothers will be selected in consideration of the dropout rate due to the characteristics of mothers. The study group and control group will be computer-generated in a 1:1 ratio through random assignment. The research group will receive health management items through the app, and health management information suitable for the pregnancy cycle is pushed to an alarm. The control group will receive the health management information of the paper. We also followed the procedure for developing mobile apps using the IDEAS framework.
DISCUSSION


These results show the effectiveness of smart medical healthcare services and promote changes in health behaviors throughout pregnancy in high-risk mothers.
TRIAL REGISTRATION


Clinical trial registration information for this study has been registered with WHO ICTRP and CRIS (Korea Clinical Research Information Service, CRIS). Clinical trial registration information is as follows: Study of development of integrated smart health management service for the whole life cycle of high-risk mothers and newborns based on community, KCT0007193 . Registered on April 14, 2022, prospectively registered. This protocol version is Version 1.0. April 14, 2022.",2022,"These results show the effectiveness of smart medical healthcare services and promote changes in health behaviors throughout pregnancy in high-risk mothers.
","['high-risk mothers and newborns', 'health management of high-risk mothers', 'mothers 18\xa0years of age or older with health care information collected based on evidence-based literature data using a smartphone app for 6\xa0weeks', '500 mothers']","['smartphone app-based health care intervention', 'integrated smart health management service']",['health behaviors'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0358088,"These results show the effectiveness of smart medical healthcare services and promote changes in health behaviors throughout pregnancy in high-risk mothers.
","[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Medicine, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Jong Youn', 'Initials': 'JY', 'LastName': 'Moon', 'Affiliation': 'Department of Preventive Medicine, Gachon University College of Medicine, Incheon, Republic of Korea. moonjy@gachon.ac.kr.'}, {'ForeName': 'Jae Yong', 'Initials': 'JY', 'LastName': 'Shin', 'Affiliation': 'Department of Preventive Medicine & Institute of Health Services Research, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hae Rin', 'Initials': 'HR', 'LastName': 'Jeon', 'Affiliation': 'Department of Obstetrics and Gynecology, Gachon University of Gil Medical Center, Incheon, 21565, Republic of Korea.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Oh', 'Affiliation': 'Department of Social & Behavioral Sciences, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Suk Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Gachon University of Gil Medical Center, Incheon, 21565, Republic of Korea. ksyob@gilhospital.com.'}]",Trials,['10.1186/s13063-022-06425-3']
1739,35698154,"Correction: ALIMUS-We are feeding! Study protocol of a multi-center, cluster-randomized controlled trial on the effects of a home garden and nutrition counseling intervention to reduce child undernutrition in rural Burkina Faso and Kenya.",,2022,,['child undernutrition in rural Burkina Faso and Kenya'],"['Correction', 'home garden and nutrition counseling intervention']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0850385,,"[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mank', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital Heidelberg, Heidelberg University, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.'}, {'ForeName': 'Raissa', 'Initials': 'R', 'LastName': 'Sorgho', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital Heidelberg, Heidelberg University, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.'}, {'ForeName': 'Fanta', 'Initials': 'F', 'LastName': 'Zerbo', 'Affiliation': 'Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.'}, {'ForeName': 'Moubassira', 'Initials': 'M', 'LastName': 'Kagoné', 'Affiliation': 'Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Oguso', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), Kisumu, Kenya.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mbata', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), Kisumu, Kenya.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Khagayi', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), Kisumu, Kenya.'}, {'ForeName': 'Erick M O', 'Initials': 'EMO', 'LastName': 'Muok', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), Kisumu, Kenya.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna (CRSN), Nouna, Burkina Faso.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Danquah', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital Heidelberg, Heidelberg University, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany. ina.danquah@uni-heidelberg.de.'}]",Trials,['10.1186/s13063-022-06450-2']
1740,35698591,"The Combination of Betahistine and Oxybutynin Increases Respiratory Control Sensitivity (Loop Gain) in People with Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial.","Rationale


There are widespread histaminergic projections throughout the brain, including hypoglossal nuclei, that modulate pharyngeal muscle tone and respiratory control. Hence, histaminergic stimulation pharmacologically may increase pharyngeal muscle tone and stabilize respiratory control (loop gain) to reduce obstructive sleep apnea (OSA) severity. Antimuscarinics also increase REM pharyngeal muscle tone in rats. Thus, a combination of histaminergic and anti-muscarinic drugs may be a novel target for OSA pharmacotherapy. However, this has not been investigated. Accordingly, we aimed to test the effects of betahistine (Beta), an H3-autoreceptor antagonist which thereby increases histamine levels, in combination with the antimuscarinic oxybutynin (Oxy), on OSA severity, OSA endotypes, polysomnography parameters and next-day sleepiness and alertness.
Methods


Thirteen adults with OSA received either Beta-Oxy (96-5mg) or placebo according to a randomized, crossover, double-blind design, prior to polysomnography. Participants completed the Karolinska Sleep Scale and Leeds Sleep Evaluation Questionnaire and a driving simulation task to quantify next-day sleepiness and alertness. OSA endotypes were estimated through validated algorithms using polysomnography.
Results


Compared to placebo, Beta-Oxy increased respiratory control sensitivity (loop gain) (0.52[0.24] vs 0.60[0.34], median [IQR], P = 0.021) without systematically changing OSA severity (34.4±17.2 vs 40.3±27.3 events/h, mean±SD, P = 0.124), sleep efficiency, arousal index or markers of hypoxemia. Beta-Oxy was well tolerated and did not worsen next-day sleepiness/alertness.
Conclusion


Rather than stabilize breathing during sleep, Beta-Oxy increases loop gain, which is likely to be deleterious for most people with OSA. However, in certain conditions characterized by blunted respiratory control (eg, obesity hypoventilation syndrome), interventions to increase loop gain may be beneficial.",2022,"Compared to placebo, Beta-Oxy increased respiratory control sensitivity (loop gain) (0.52[0.24] vs 0.60[0.34], median [IQR], P = 0.021) without systematically changing OSA severity (34.4±17.2 vs 40.3±27.3 events/h, mean±SD, P = 0.124), sleep efficiency, arousal index or markers of hypoxemia.","['Thirteen adults with OSA', 'People with Obstructive Sleep Apnea', 'rats']","['betahistine (Beta', 'stabilize breathing during sleep', 'Beta-Oxy', 'Betahistine and Oxybutynin Increases Respiratory Control Sensitivity (Loop Gain', 'placebo', 'Placebo']","['REM pharyngeal muscle tone', 'sleep efficiency, arousal index or markers of hypoxemia', 'Karolinska Sleep Scale and Leeds Sleep Evaluation Questionnaire and a driving simulation task to quantify next-day sleepiness and alertness', 'obstructive sleep apnea (OSA) severity', 'OSA severity, OSA endotypes, polysomnography parameters and next-day sleepiness and alertness', 'respiratory control sensitivity', 'OSA severity', 'histamine levels']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0005301', 'cui_str': 'BETAHISTINE'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0069805', 'cui_str': 'oxybutynin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0031346', 'cui_str': 'Muscle structure of pharynx'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1168027', 'cui_str': 'Histamine level'}]",13.0,0.20899,"Compared to placebo, Beta-Oxy increased respiratory control sensitivity (loop gain) (0.52[0.24] vs 0.60[0.34], median [IQR], P = 0.021) without systematically changing OSA severity (34.4±17.2 vs 40.3±27.3 events/h, mean±SD, P = 0.124), sleep efficiency, arousal index or markers of hypoxemia.","[{'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Messineo', 'Affiliation': 'Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Loffler', 'Affiliation': 'Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Chiang', 'Affiliation': 'Neuroscience Research Australia, Randwick, NSW, Australia.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Osman', 'Affiliation': 'Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Taranto-Montemurro', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA, Australia.'}]",Nature and science of sleep,['10.2147/NSS.S362205']
1741,35698824,Comparison of efficacy of autologous blood patch pleurodesis versus doxycycline pleurodesis in the management of persistent air leak in patients with secondary spontaneous pneumothorax. A randomized control trial.,"Secondary spontaneous pneumothorax (SSP) patients sometimes have a persistent air leak (PAL) that leads to increased morbidity and increased hospital stay. Further, these patients also need pleurodesis to prevent a recurrence. Autologous blood patch pleurodesis (ABPP) has been successfully tried in post lobectomy air leak cases. However, its utility in SSP patients with PAL has not been widely established. In this context, we performed a non-blinded randomized control study to compare the efficacy of ABPP vs doxycycline pleurodesis in the closure of air leak in SSP patients. This study was a non-blinded randomized control study done in 38 SSP patients with PAL. They were randomized into doxycycline arm and ABPP arm. Post pleurodesis air leak was assessed every 12 hours for cessation. Success was considered when there was a complete cessation of air leak. Post-procedural complications were noted and patients were followed up for 28 days to look for recurrence. The median time for closure was 24 hours [interquartile range (12.24)] for ABPP and 36 hours [interquartile range (24.72)] for doxycycline pleurodesis. Success rate of ABPP vs doxycycline pleurodesis is 94.7% vs 84.2% (p=0.6). Post-procedure pain was more in doxycycline group (15% vs 73%) (p<0.01). On visual analogue scale, ABPP had a lesser pain as compared to doxycycline pleurodesis (average visual analogue scale value of 2 vs scale of 7). The recurrence rate was equal in both groups (5%). Though ABPP and doxycycline have similar success rates, ABPP has an early closure of air leak and greater patient tolerability. ABPP can be tried as an alternative to doxycycline pleurodesis in SSP patients with persistent air leaks.",2022,Post-procedure pain was more in doxycycline group (15% vs 73%) (p<0.01).,"['SSP patients with persistent air leaks', '38 SSP patients with PAL', 'SSP patients with PAL', 'patients with secondary spontaneous pneumothorax', 'SSP patients']","['Autologous blood patch pleurodesis (ABPP', 'doxycycline', 'ABPP vs doxycycline pleurodesis', 'ABPP', 'autologous blood patch pleurodesis', 'doxycycline pleurodesis']","['closure of air leak', 'recurrence rate', 'hospital stay', 'persistent air leak', 'visual analogue scale, ABPP had a lesser pain', 'Success rate of ABPP', 'median time for closure']","[{'cui': 'C0149781', 'cui_str': 'Spontaneous pneumothorax'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C3161098', 'cui_str': 'Secondary spontaneous pneumothorax'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}]","[{'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0487197,Post-procedure pain was more in doxycycline group (15% vs 73%) (p<0.01).,"[{'ForeName': 'Vijayarangam', 'Initials': 'V', 'LastName': 'Narenchandra', 'Affiliation': 'Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. drnaren00@gmail.com.'}, {'ForeName': 'Govindaraj', 'Initials': 'G', 'LastName': 'Vishnukanth', 'Affiliation': 'Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. vishnu1429@yahoo.com.'}, {'ForeName': 'Dharm Prakash', 'Initials': 'DP', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. dippyd@gmail.com.'}, {'ForeName': 'Munuswamy', 'Initials': 'M', 'LastName': 'Hemachandren', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. mhchandren@gmail.com.'}, {'ForeName': 'Subathra', 'Initials': 'S', 'LastName': 'Adithian', 'Affiliation': 'Department of Radiodiagnosis, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. subathra26@gmail.com.'}, {'ForeName': 'Saka', 'Initials': 'S', 'LastName': 'Vinod Kumar', 'Affiliation': 'Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. vinoddayamani@hotmail.com.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Rajangam', 'Affiliation': 'Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. mail2manju22@gmail.com.'}, {'ForeName': 'Madhusmita Mohanty', 'Initials': 'MM', 'LastName': 'Mohapatra', 'Affiliation': 'Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. drmadhusmita1@gmail.com.'}, {'ForeName': 'Pratap', 'Initials': 'P', 'LastName': 'Upadhya', 'Affiliation': 'Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. drpratapu@gmail.com.'}]",Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace,['10.4081/monaldi.2022.2036']
1742,35698782,Role of suprascapular nerve block in idiopathic frozen shoulder treatment: a clinical trial survey.,"BACKGROUND


Several therapeutic methods have been proposed for frozen shoulder syndrome. These include suprascapular nerve block, a simple and cost-effective technique that eliminates the need for nonsteroidal anti-inflammatory drug therapy.
METHODS


This was a clinical trial that included patients with unilateral shoulder joint stiffness. Patients were divided into three groups: those treated with isolated physiotherapy for 12 weeks (PT group), those treated with a single dose intra-articular injection of corticosteroid together with physiotherapy (IACI group), and those treated with a suprascapular nerve block performed with a single indirect injection of 8-mL lidocaine HCL 1% and 2 mL (80 mg) methylprednisolone acetate together with physiotherapy (SSNB group). The variables assessed were age, sex, side of involvement, dominant limb, presence of diabetes, physical examination findings including erythema, swelling, and muscle wasting; palpation and movement findings; shoulder pain and disability index (SPADI) score; and the visual analog scale (VAS) score pre-intervention and at 2-, 4-, 6-, and 12-week post-intervention.
RESULTS


Ninety-seven patients were included in this survey (34 cases in the PT group, 32 cases in the IACI group, and 31 cases in the SSNB group). Mean age was 48.55±11.06 years. Fifty-seven cases were female (58.8%) and 40 were male (41.2%). Sixty-eight patients had a history of diabetes (70.1%). VAS and SPADI scores and range of mototion degrees dramatically improved in all cases (p<0.001). Results were best in the SSNB group (p<0.001), and the IACI group showed better results than the PT group (p<0.001).
CONCLUSIONS


Suprascapular nerve block is an effective therapy with long-term pain relief and increased mobility of the shoulder joint in patients with adhesive capsulitis.",2022,VAS and SPADI scores and range of mototion degrees dramatically improved in all cases (p<0.001).,"['Fifty-seven cases were female (58.8%) and 40 were male (41.2', 'patients with adhesive capsulitis', 'Sixty-eight patients had a history of diabetes (70.1', 'Ninety-seven patients were included in this survey (34 cases in the PT group, 32 cases in the IACI group, and 31 cases in the SSNB group', 'patients with unilateral shoulder joint stiffness', 'idiopathic frozen shoulder treatment']","['suprascapular nerve block', 'corticosteroid together with physiotherapy (IACI group), and those treated with a suprascapular nerve block performed with a single indirect injection of 8-mL lidocaine HCL 1% and 2 mL (80 mg) methylprednisolone acetate together with physiotherapy (SSNB group', 'isolated physiotherapy']","['VAS and SPADI scores and range of mototion degrees', 'erythema, swelling, and muscle wasting; palpation and movement findings; shoulder pain and disability index (SPADI) score; and the visual analog scale (VAS) score pre-intervention']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0241042', 'cui_str': 'Shoulder stiff'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine hydrochloride'}, {'cui': 'C0600901', 'cui_str': 'Methylprednisolone acetate'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",97.0,0.0177272,VAS and SPADI scores and range of mototion degrees dramatically improved in all cases (p<0.001).,"[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mardani-Kivi', 'Affiliation': 'Orthopaedic Research Center, Department of Orthopaedic, Poursina Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Bahram Naderi', 'Initials': 'BN', 'LastName': 'Nabi', 'Affiliation': 'Anesthesiology Research Center, Department of Anesthesiology, Alzahra Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mir-Hashem', 'Initials': 'MH', 'LastName': 'Mousavi', 'Affiliation': 'Orthopaedic Research Center, Department of Orthopaedic, Poursina Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Ardeshir', 'Initials': 'A', 'LastName': 'Shirangi', 'Affiliation': 'Orthopaedic Research Center, Department of Orthopaedic, Poursina Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Ehsan Kazemnejad', 'Initials': 'EK', 'LastName': 'Leili', 'Affiliation': 'Department of Statistics, School of Health, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Zahra Haghparast', 'Initials': 'ZH', 'LastName': 'Ghadim-Limudahi', 'Affiliation': 'Orthopaedic Research Center, Department of Orthopaedic, Poursina Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]",Clinics in shoulder and elbow,['10.5397/cise.2021.00661']
1743,35698748,"The Effect of Holistic Birth Support Strategies on Coping With Labor Pain, Birth Satisfaction, and Fear of Childbirth: A Randomized, Triple-Blind, Controlled Trial.","The current study was aimed to evaluate the effects of interventions conducted in line with the coping with labor pain algorithm (holistic birth support strategies) on women's coping with labor pain, birth satisfaction, and fear of childbirth. The study is a single-center, parallel-group randomized, three-blind, controlled trial. The study was completed with 33 women in the experimental group and 31 in the control group. The mean score of the women in the experimental group from the Birth Satisfaction Scale (128.57 ± 5.83) was statistically significantly higher than that of the women in the control group (81.80 ± 7.73). The mean score of the women in the experimental group (61.96 ± 9.78) from the Wijma Birth Expectation/Experience Scale, Version B scale was statistically significantly lower than that of the women in the control group (148.64 ± 14.62). It was found that the women in the experimental group were able to better cope with labor pain, had higher birth satisfaction, and had less fear of childbirth.",2022,"It was found that the women in the experimental group were able to better cope with labor pain, had higher birth satisfaction, and had less fear of childbirth.","['33 women in the experimental group and 31 in the control group', ""women's coping with labor pain, birth satisfaction, and fear of childbirth""]","['labor pain algorithm (holistic birth support strategies', 'Holistic Birth Support Strategies']","['Wijma Birth Expectation/Experience Scale, Version B scale', 'Birth Satisfaction Scale', 'mean score', 'Coping With Labor Pain, Birth Satisfaction, and Fear of Childbirth', 'fear of childbirth', 'birth satisfaction', 'labor pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia'}]","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia'}]",,0.133987,"It was found that the women in the experimental group were able to better cope with labor pain, had higher birth satisfaction, and had less fear of childbirth.","[{'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Akbaş', 'Affiliation': 'Karabük Yenice State Hospital, Karabük, Turkey.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Özkan Şat', 'Affiliation': 'Bitlis Eren University, Faculty of Health Sciences, Nursing Department, Bitlis, Turkey.'}, {'ForeName': 'Şengül', 'Initials': 'Ş', 'LastName': 'Yaman Sözbir', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Nursing Department, Ankara, Turkey.'}]",Clinical nursing research,['10.1177/10547738221103329']
1744,35698711,Levetiracetam Versus Levetiracetam Plus Sodium Channel Blockers for Postoperative Epileptic Seizure Prevention in Brain Tumor Patients.,"Background Brain tumor patients tend to develop postoperative epileptic seizures, which can lead to an unfavorable outcome. Although the incidence of postoperative epileptic seizures and adverse events are improved with the advent of levetiracetam (LEV), postoperative epilepsy occurs at a frequency of 4.6% or higher. In brain tumor patients, the addition of sodium channel blockers (SCBs) to LEV significantly reduces seizures, though confirmed in a non-postoperative study. Thus, the combination of SCBs with LEV might be promising. Objective In this prospective randomized controlled trial we investigated the safety, evaluated by adverse events during one and two weeks after surgery, and the efficacy, evaluated by the incidence of early epilepsy, including non-convulsive status epilepticus (NCSE), of using LEV alone or SCBs added to LEV in patients who underwent craniotomy or biopsy for brain tumors or brain mass lesions. Methods Patients with brain tumors or brain mass lesions undergoing surgical interventions, excluding endoscopic endonasal surgery (EES), with a diagnosis of epilepsy were eligible for this study. Patients are randomized into either Group A or B (B1 or B2) after the informed consents are taken; LEV alone in Group A patients, while LEV and SCBs in Group B patients (GroupB1, intravenous fosphenytoin plus oral lacosamide (LCM) and GroupB2, intravenous LCM plus oral LCM) were administered postoperatively. Fifty-three patients were enrolled during the first two and a half years of the study and four of them were excluded, resulting in the accumulation of 49 patients' data. Results Postoperative epileptic seizures occurred only in three out of 49 patients during the first week (6.1%) and in seven patients within two weeks after surgery (14.3%, including the three patients during the first week). In Group A, epileptic seizures occurred in two out of 26 patients during the first week (7.7%) and in five patients within two weeks (19.2%) after surgery. In Group B, epileptic seizures occurred in one out of 23 patients during the first week (4.3%) and in two patients during the first two weeks (8.7%). Low complication grade of epileptic seizures was observed in Group B rather than in Group A, however, without significant difference (p=0.256). There was no difference in the frequency of adverse effects in each group. Conclusion Although not statistically significant, the incidence of epileptic seizures within one week after surgery was lesser in LEV+SCBs groups than in LEV alone. No hepatic damage or renal function worsening occurred with the addition of LCM, suggesting the safety of LEV+SCBs therapy.",2022,"Although not statistically significant, the incidence of epileptic seizures within one week after surgery was lesser in LEV+SCBs groups than in LEV alone.","['patients who underwent craniotomy or biopsy for brain tumors or brain mass lesions', ""Fifty-three patients were enrolled during the first two and a half years of the study and four of them were excluded, resulting in the accumulation of 49 patients' data"", 'Brain Tumor Patients', 'Methods Patients with brain tumors or brain mass lesions undergoing surgical interventions, excluding endoscopic endonasal surgery (EES), with a diagnosis of epilepsy were eligible for this study']","['levetiracetam (LEV', 'LEV alone or SCBs added to LEV', 'LEV alone in Group A patients, while LEV and SCBs in Group B patients (GroupB1, intravenous fosphenytoin plus oral lacosamide (LCM) and GroupB2, intravenous LCM plus oral LCM', 'Levetiracetam Versus Levetiracetam Plus Sodium Channel Blockers', 'LCM']","['Postoperative epileptic seizures', 'Low complication grade of epileptic seizures', 'frequency of adverse effects', 'postoperative epileptic seizures', 'hepatic damage or renal function worsening', 'postoperative epileptic seizures and adverse events', 'incidence of epileptic seizures', 'epileptic seizures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0742078', 'cui_str': 'Mass lesion of brain'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0225425', 'cui_str': 'Internal nose structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0023726', 'cui_str': 'Lincomycin'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",53.0,0.0525521,"Although not statistically significant, the incidence of epileptic seizures within one week after surgery was lesser in LEV+SCBs groups than in LEV alone.","[{'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Watanabe', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Narushi', 'Initials': 'N', 'LastName': 'Sugii', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Sakakura', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Matsuda', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kohzuki', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tsurubuchi', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Masuda', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zaboronok', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Kino', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Mikito', 'Initials': 'M', 'LastName': 'Hayakawa', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Takano', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsumaru', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Akutsu', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, JPN.'}]",Cureus,['10.7759/cureus.24894']
1745,35699261,"First-in-Human Single-Ascending-Dose, Multiple-Dose, and Food Interaction Studies of NRD.E1, an Innovative Nonopioid Therapy for Painful Diabetic Peripheral Neuropathy.","Painful diabetic peripheral neuropathy is characterized by burning, stabbing, or electric shock-type pain, which severely impacts day-to-day functioning and quality of life. Here, we report the results of 3 phase I studies with NRD135S.E1 (referred to as NRD.E1), a new, orally available chemical entity, presently developed for the treatment of painful diabetic peripheral neuropathy. The first study was a first-in-human, randomized, placebo-controlled, single-ascending-dose study, where NRD.E1 was administered to healthy male subjects in single dosages ranging from 300 to 1200 mg. The second study was a randomized, placebo-controlled multiple-dose study, where healthy male subjects received 300 mg of NRD.E1 once daily for 5 consecutive days. The third study was an open-label food interaction study in healthy men and women following a crossover design, where NRD.E1 was administered under fed and fasted conditions at 40 mg. The studies revealed dose-dependent absorption, increased exposure to NRD.E1 when administered with food, and no relevant accumulation after once-daily administration. All 3 phase I studies consistently showed rapid absorption of orally administered NRD.E1 followed by fast elimination, mainly via metabolization (glucuronidation), and small secondary increases in plasma concentrations. NRD.E1 was well tolerated, with no subject discontinuation due to treatment-emergent adverse events in any study.",2022,"NRD.E1 was well tolerated, with no subject discontinuation due to treatment-emergent adverse events in any study.","['healthy male subjects', 'healthy men and women', 'painful diabetic peripheral neuropathy', 'Painful Diabetic Peripheral Neuropathy', 'healthy male subjects in single dosages ranging from 300 to 1200 mg']","['NRD135S.E1', 'placebo', 'NRD.E1']","['rapid absorption', 'plasma concentrations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517548', 'cui_str': '1200'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0656539,"NRD.E1 was well tolerated, with no subject discontinuation due to treatment-emergent adverse events in any study.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tiecke', 'Affiliation': 'Novaremed AG, Basel, Switzerland.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Rainisio', 'Affiliation': 'Novaremed AG, Basel, Switzerland.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Guentert', 'Affiliation': 'PK-Insights GmbH, Boeckten, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'smv3.ch GmbH, Liestal, Switzerland.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Hochman', 'Affiliation': 'Novaremed Ltd, Tel Aviv, Israel.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Kaplan', 'Affiliation': 'Novaremed AG, Basel, Switzerland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mangialaio', 'Affiliation': 'Novaremed AG, Basel, Switzerland.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1103']
1746,35699238,"Results of a randomized, placebo-controlled, first-in-human trial of topical CY-002 in patients with cutaneous warts.",,2022,,['patients with cutaneous warts'],"['topical CY-002', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.319938,,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pagan', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yfanti', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rijneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jongste', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Feijen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Klaassen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Bouwes Bavinck', 'Affiliation': 'Department of Dermatology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Struijk', 'Affiliation': 'Viroclinics-DDL, DDL Diagnostic Laboratory, Rijswijk, The Netherlands.'}, {'ForeName': 'M N C', 'Initials': 'MNC', 'LastName': 'de Koning', 'Affiliation': 'Viroclinics-DDL, DDL Diagnostic Laboratory, Rijswijk, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Prestegarden', 'Affiliation': 'Cytovation AS, Bergen, Norway.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Niemeyer-van der Kolk', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'M I E', 'Initials': 'MIE', 'LastName': 'van Poelgeest', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rissmann', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.18291']
1747,35699175,Sex-Specific Differences in Clinical Outcomes After Percutaneous Coronary Intervention: Insights from the TAILOR-PCI Trial.,"Background TAILOR-PCI (Tailored Antiplatelet Initiation to Lessen Outcomes due to decreased Clopidogrel Response After Percutaneous Coronary Intervention) studied genotype-guided selection of antiplatelet therapy after percutaneous coronary intervention versus conventional therapy with clopidogrel. The presence of  CYP2C19  loss-of-function alleles in patients treated with clopidogrel may be associated with increased risk for ischemic events. We report a prespecified sex-specific analysis of genotyping and associated cardiovascular outcomes from this study. Methods and Results Associations between sex and major adverse cardiac events (MACE: cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia) and Bleeding Academic Research Consortium (BARC) bleeding at 12 months were analyzed using Cox proportional-hazards models. Among 5276 randomized patients, loss-of-function carriers were observed in ≈36% of both sexes, and >80% of carriers were heterozygotes. At 12 months, after adjustment for baseline differences, risks of MACE (HR , 1.28 [0.97 to 1.68];  P =0.088) and BARC bleeding (hazard ratio [HR], 1.36 [0.91 to 2.05];  P =0.14) were comparable among women and men. There were no significant interactions between sex and treatment strategy for MACE interaction  P  value ( P int =0.59) or BARC bleeding ( P int =0.47) nor for sex and genotype (MACE  P int =0.15, and BARC bleeding  P int =0.60). Conclusions  CYP2C19  loss-of-function alleles were present in ≈1 in 3 women and men. Women had similar adjusted risks of MACE and bleeding as men following percutaneous coronary intervention. Genotype-guided therapy did not significantly reduce the risk of MACE or bleeding relative to conventional therapy for both sexes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01742117.",2022,"There were no significant interactions between sex and treatment strategy for MACE interaction  P  value ( P int =0.59) or BARC bleeding ( P int =0.47) nor for sex and genotype (MACE  P int =0.15, and BARC bleeding  P int =0.60).",[],"['percutaneous coronary intervention versus conventional therapy with clopidogrel', 'clopidogrel', 'Genotype-guided therapy']","['risk for ischemic events', 'Clopidogrel Response', 'BARC bleeding', 'loss-of-function carriers', 'adjusted risks of MACE and bleeding', 'sex and major adverse cardiac events (MACE: cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia) and Bleeding Academic Research Consortium (BARC) bleeding', 'risk of MACE or bleeding relative']",[],"[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",5276.0,0.0412664,"There were no significant interactions between sex and treatment strategy for MACE interaction  P  value ( P int =0.59) or BARC bleeding ( P int =0.47) nor for sex and genotype (MACE  P int =0.15, and BARC bleeding  P int =0.60).","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Madan', 'Affiliation': 'Schulich Heart CentreSunnybrook Health Sciences CentreUniversity of Toronto Toronto Ontario Canada.'}, {'ForeName': 'J Dawn', 'Initials': 'JD', 'LastName': 'Abbott', 'Affiliation': 'Division of Cardiology Lifespan Cardiovascular Institute Warren Alpert Medical School of Brown University Providence RI.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lennon', 'Affiliation': 'Department of Quantitative Health Sciences Mayo Clinic Rochester MN.'}, {'ForeName': 'Derek Y F', 'Initials': 'DYF', 'LastName': 'So', 'Affiliation': 'University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'MacDougall', 'Affiliation': 'Thunder Bay Regional Health Sciences Centre Thunder Bay Ontario Canada.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'McLaughlin', 'Affiliation': 'Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Vishakantha', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Department of Cardiovascular Medicine Mayo Clinic Rochester MN.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Saw', 'Affiliation': 'Vancouver General HospitalUniversity of British Columbia Vancouver British Columbia Canada.'}, {'ForeName': 'Charanjit', 'Initials': 'C', 'LastName': 'Rihal', 'Affiliation': 'Department of Cardiovascular Medicine Mayo Clinic Rochester MN.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac CentreUniversity of Toronto Ontario Canada.'}, {'ForeName': 'Naveen L', 'Initials': 'NL', 'LastName': 'Pereira', 'Affiliation': 'Department of Cardiovascular Medicine Mayo Clinic Rochester MN.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St. Michael's HospitalUniversity of Toronto Ontario Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.121.024709']
1748,35694717,Patient-directed vs. fixed-volume PEG for colonoscopy preparation: a randomized controlled trial.,"Background


Individualization using different volumes of polyethylene glycol is widely regarded as the optimal solution for bowel preparation, while the patient-directed regimen we propose may serve as a reliable individual solution. This study aimed to assess the efficacy, safety, and satisfaction of bowel preparation with a patient-directed regimen.
Methods


Patients in the fixed-volume group ingested the same amount of PEG, while those in patient-directed group ingested different amount according to stool consistency or stool water content.
Results


After filtering by exclusion criteria, 428 individuals in the fixed-volume group and 103 in the patient-directed group were successfully enrolled and analyzed. Eighty-three (80.6%) individuals in the patient-directed group had a reduced polyethylene glycol volume. There was no significant difference in the bowel preparation efficacy between the two groups (90.0% vs. 90.3%, χ² = 0.01;  p  = 0.918). Patients in the patient-directed group complained of fewer adverse effects (53.0% vs. 36.9%, χ² = 8.655;  p  = 0.003), especially vomiting (13.6% vs. 1.0%, χ² = 13.304;  p  < 0.001). Regarding comfort during bowel preparation, the degree of comfort was not significantly different between groups. Furthermore, the willingness rate for further colonoscopy in the patient-directed group was significantly higher than that in the fixed-volume group (90.3% vs. 77.1%, χ² = 8.912;  p  < 0.05). Multivariable logistic regression analysis showed that the body mass index served as an independent factor impacting quality of bowel preparation with the patient-directed regimen (OR 1.16, 95% CI 1.00-1.34;  p  = 0.043).
Conclusions


Without decreasing the bowel preparation efficacy, the patient-directed regimen increased the safety and satisfaction of bowel preparation and is expected to be a regular and individual solution for bowel preparation. Individuals with a lower body mass index are more likely to undertake this new regimen.
Trial registration number


ChiCTR1900022072 at ChiClinicalTrials.gov.",2022,"Patients in the patient-directed group complained of fewer adverse effects (53.0% vs. 36.9%, χ² = 8.655;  p  = 0.003), especially vomiting (13.6% vs. 1.0%, χ² = 13.304;  p  < 0.001).",['428 individuals in the fixed-volume group and 103 in the patient-directed group were successfully enrolled and analyzed'],['polyethylene glycol'],"['polyethylene glycol volume', 'willingness rate for further colonoscopy', 'degree of comfort', 'adverse effects', 'safety and satisfaction of bowel preparation', 'efficacy, safety, and satisfaction', 'bowel preparation efficacy', 'vomiting']","[{'cui': 'C4517775', 'cui_str': '428'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0387034,"Patients in the patient-directed group complained of fewer adverse effects (53.0% vs. 36.9%, χ² = 8.655;  p  = 0.003), especially vomiting (13.6% vs. 1.0%, χ² = 13.304;  p  < 0.001).","[{'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Department of Hematology, Huashan Hospital of Fudan University, Shanghai 200433, China.'}, {'ForeName': 'Yuanmei', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Hematology, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}, {'ForeName': 'Haotian', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}, {'ForeName': 'Siwei', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}, {'ForeName': 'Binglu', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}, {'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Plastic Surgery, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}]",Precision clinical medicine,['10.1093/pcmedi/pbac009']
1749,35694711,Effect of Medicine-Separated Moxibustion on Navel Combined with Mind-Regulating Acupuncture on Curative Effect and Quality of Life in Patients with Allergic Rhinitis.,"Objective


To explore the effect of medicine-separated moxibustion combined with mind-regulating acupuncture on the efficacy and quality of life of patients with allergic rhinitis (AR).
Methods


Sixty patients with AR cured from February 2019 to April 2021 were enrolled in our hospital. The patients were arbitrarily assigned into control and study groups. The former group was treated with herbal moxibustion on the navel, while the latter group was treated with herbal moxibustion on the navel combined with mind-regulating acupuncture. The curative effect, TNSS score, TNNSS score, RQLQ score, and the incidence of adverse events were compared.
Results


Compared with the two groups, the study group was markedly effective in 24 cases, effective in 5 cases, and ineffective in 1 case, with an effective rate of 100.00%, while the control group was markedly effective in 13 cases, effective in 10 cases, and ineffective in 7 cases, with an effective rate of 100.00%. The curative effect of the study group was better compared to the control group ( P  < 0.05). There was no remarkable difference in TNSS score before treatment ( P  > 0.05). After treatment, the TNSS scores of patients decreased. Compared with the control group, the TNSS score of the study group was lower than that of the control group at 2 weeks, 4 weeks and during the follow-up. No remarkable difference appeared in the TNNSS score before treatment ( P  > 0.05). After treatment, the TNNSS scores of patients were decreased. Comparing the two groups, the TNNSS scores of the study group were lower compared to the control group after 2 weeks of treatment, 4 weeks of treatment and during the follow-up period ( P  < 0.05). There was no remarkable difference in the RQLQ score before treatment ( P  > 0.05). After treatment, the RQLQ scores of patients were decreased. Comparing the two groups, the RQLQ scores of the study group were lower compared to the control group at 2 weeks, 4 weeks after treatment and during the follow-up period ( P  < 0.05). In terms of the incidence of adverse events, the incidence of adverse events such as subcutaneous hematoma, bruising, and induration in the study group was lower compared to the control group ( P  < 0.05).
Conclusion


Medicine-separated moxibustion was combined with mind-regulating acupuncture when treating AR. There were differences in clinical efficacy, single-symptom score, and TNSS, TNNSS, and RQLQ scores, which verified the clinical efficacy of medicine-separated moxibustion combined with mind-regulating acupuncture when treating AR, and expounded the mechanism of medicine-separated moxibustion combined with mind-regulating acupuncture when treating AR. In the meantime, it shows that the umbilical method of medicine-separated moxibustion combined with mind-regulating acupuncture when treating AR has the advantages of definite short-term effect, long-term effect, safe and simple operation, and no adverse reactions, which is worthy of clinical application.",2022,"Comparing the two groups, the TNNSS scores of the study group were lower compared to the control group after 2 weeks of treatment, 4 weeks of treatment and during the follow-up period ( P  < 0.05).","['Patients with Allergic Rhinitis', 'patients with allergic rhinitis (AR', 'Sixty patients with AR cured from February 2019 to April 2021 were enrolled in our hospital']","['medicine-separated moxibustion combined with mind-regulating acupuncture', 'Medicine-separated moxibustion was combined with mind-regulating acupuncture', 'herbal moxibustion on the navel combined with mind-regulating acupuncture', 'Medicine-Separated Moxibustion', 'herbal moxibustion', 'Mind-Regulating Acupuncture']","['TNNSS scores', 'adverse events, the incidence of adverse events such as subcutaneous hematoma, bruising, and induration', 'TNSS score', 'curative effect, TNSS score, TNNSS score, RQLQ score, and the incidence of adverse events', 'Curative Effect and Quality of Life', 'RQLQ score', 'curative effect', 'clinical efficacy, single-symptom score, and TNSS, TNNSS, and RQLQ scores', 'effective rate', 'RQLQ scores', 'efficacy and quality of life', 'TNNSS score', 'TNSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520532', 'cui_str': 'Subcutaneous hematoma'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0375633,"Comparing the two groups, the TNNSS scores of the study group were lower compared to the control group after 2 weeks of treatment, 4 weeks of treatment and during the follow-up period ( P  < 0.05).","[{'ForeName': 'Tenggang', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'School of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan 250000, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'First Clinical School of Medicine, Shandong University of Traditional Chinese Medicine, Jinan 250000, China.'}, {'ForeName': 'Renzhong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology, The First Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250000, China.'}]",Contrast media & molecular imaging,['10.1155/2022/4093891']
1750,35694710,Intelligent Algorithm-Based MRI Image Features for Evaluating the Effect of Nursing on Recovery of the Neurological Function of Patients with Acute Stroke.,"The aim of this study is to analyze the application of early rehabilitation nursing in nursing intervention of neurological impairment among patients with acute ischemic stroke. 116 patients with acute ischemic stroke were selected as the research subjects in this paper. The patients were divided into 58 experimental (early rehabilitation care) and 58 control (routine rehabilitation care) groups according to the difference of care protocols, all of which were performed magnetic resonance imaging on. An image resolution reconstruction algorithm on the basis of deep convolutional neural network is proposed for MRI image processing. The results show that peak signal to noise ratio (PSNR) and structural similarity index measure (SSIM) of the included algorithm were remarkably greater than those of compressed sensing (CS) algorithm and nonlocal similarity and block low rank prior-based NSBL algorithm. Running time was shorter than that of the latter two algorithms ( P  < 0.05). The neurological impairment scores of patients in the experimental group 3 and 5 weeks after treatment were obviously lower than those of patients in the control group ( P  < 0.05). The Barthel indexes of patients in the experimental group 3 and 5 weeks after treatment were obviously higher than those of patients in the control group ( P  < 0.05). FugI-Meyer assessment (FMA) and Disability of Arm-Shoulder-Hand (DASH) scores of patients in the experimental group 3 and 5 weeks after treatment were obviously lower than those of patients in control group ( P  < 0.05). The results show that the deep learning algorithm for MRI image processing performance is better than the traditional algorithm. It not only improves the image quality but also improves the processing efficiency. Early rehabilitation nursing and routine rehabilitation nursing can effectively improve the neurological deficit symptoms, limb motor function, and daily living ability of patients with acute ischemic stroke, and the effect of early rehabilitation nursing is the best.",2022,The neurological impairment scores of patients in the experimental group 3 and 5 weeks after treatment were obviously lower than those of patients in the control group ( P  < 0.05).,"['patients with acute ischemic stroke', 'Patients with Acute Stroke', '116 patients with acute ischemic stroke']",['58 experimental (early rehabilitation care) and 58 control (routine rehabilitation care'],"['neurological deficit symptoms, limb motor function, and daily living ability', 'DASH) scores', 'neurological impairment scores', 'Running time', 'image quality', 'FugI-Meyer assessment (FMA) and Disability of Arm-Shoulder-Hand', 'peak signal to noise ratio (PSNR) and structural similarity index measure (SSIM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",116.0,0.0198454,The neurological impairment scores of patients in the experimental group 3 and 5 weeks after treatment were obviously lower than those of patients in the control group ( P  < 0.05).,"[{'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Shengjing Hospital of China Medical University, Liaoning 110000, Shenyang, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Department of Neurosurgery, Shengjing Hospital of China Medical University, Liaoning 110000, Shenyang, China.'}]",Contrast media & molecular imaging,['10.1155/2022/3936655']
1751,35694653,Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: A multi-centred randomized controlled trial.,"Background


Current evidence points towards a high prevalence of psychological distress in refugee populations, contrasting with a scarcity of resources and amplified by linguistic, institutional, financial, and cultural barriers. The objective of the study is to investigate the overall effectiveness and cost-effectiveness of a Stepped Care and Collaborative Model (SCCM) at reducing depressive symptoms in refugees, compared with the overall routine care practices within Germany's mental healthcare system (treatment-as-usual, TAU).
Methods


A multicentre, clinician-blinded, randomised, controlled trial was conducted across seven university sites in Germany. Asylum seekers and refugees with relevant depressive symptoms with a Patient Health Questionnaires score of ≥ 5 and a Refugee Health Screener score of ≥ 12. Participants were randomly allocated to one of two treatment arms (SCCM or TAU) for an intervention period of three months between April 2018 and March 2020. In the SCCM, participants were allocated to interventions tailored to their symptom severity, including watchful waiting, peer-to-peer- or smartphone intervention, psychological group therapies or mental health expert treatment. The primary endpoint was defined as the change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9) after 12 weeks. The secondary outcome was the change in Montgomery Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention.
Findings


The intention-to-treat sample included 584 participants who were randomized to the SCCM (n= 294) or TAU (n=290). Using a mixed-effects general linear model with time, and the interaction of time by randomisation group as fixed effects and study site as random effect, we found significant effects for time (p < .001) and time by group interaction (p < .05) for intention-to-treat and per-protocol analysis. Estimated marginal means of the PHQ-9 scores after 12 weeks were significantly lower in SCCM than in TAU (for intention-to-treat: PHQ-9 mean difference at T 1  1.30, 95% CI 1.12 to 1.48, p < .001; Cohen's d=.23; baseline-adjusted PHQ-9 mean difference at T 1  0.57, 95% CI 0.40 to 0.74, p < .001). Cost-effectiveness and net monetary benefit analyses provided evidence of cost-effectiveness for the primary outcome and quality-adjusted life years. Robustness of results were confirmed by sensitivity analyses.
Interpretation


The SSCM resulted in a more effective and cost-effective reduction of depressive symptoms compared with TAU. Findings suggest a suitable model to provide mental health services in circumstances where resources are limited, particularly in the context of forced migration and pandemics.
Funding


This project is funded by the Innovationsfond and German Ministry of Health [grant number 01VSF16061]. The present trial is registered under Clinical-Trials.gov under the registration number: NCT03109028. https://clinicaltrials.gov/ct2/show/NCT03109028.",2022,"Estimated marginal means of the PHQ-9 scores after 12 weeks were significantly lower in SCCM than in TAU (for intention-to-treat: PHQ-9 mean difference at T 1  1.30, 95% CI 1.12 to 1.48, p < .001;","['584 participants who were randomized to the SCCM (n= 294) or TAU (n=290', 'Asylum seekers and refugees with relevant depressive symptoms with a Patient Health Questionnaires score of ≥ 5 and a Refugee Health Screener score of ≥ 12', 'seven university sites in Germany', 'depressive symptoms in refugees and asylum seekers']","['SSCM', 'watchful waiting, peer-to-peer- or smartphone intervention, psychological group therapies or mental health expert treatment', 'SCCM or TAU', 'Stepped Care and Collaborative Model (SCCM', 'TAU']","['Cost-effectiveness', 'change in Montgomery Åsberg Depression Rating Scale (MADRS', 'overall effectiveness and cost-effectiveness', 'Effectiveness and cost-effectiveness', 'PHQ-9 scores', 'change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9', 'cost-effectiveness', 'effective and cost-effective reduction of depressive symptoms']","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",584.0,0.490929,"Estimated marginal means of the PHQ-9 scores after 12 weeks were significantly lower in SCCM than in TAU (for intention-to-treat: PHQ-9 mean difference at T 1  1.30, 95% CI 1.12 to 1.48, p < .001;","[{'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Böge', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Benjamin Franklin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Karnouk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Benjamin Franklin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hoell', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Tschorn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Psychosomatics and Psychotherapy, Faculty of Human Medicine, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Kamp-Becker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilian University Munich, München, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, BKH Augsburg, Dr.-Mack-Str. 1, 86156, Augsburg, Germany.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Übleis', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, BKH Augsburg, Dr.-Mack-Str. 1, 86156, Augsburg, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy Rheinisch-Westfälische Technische Hochschule Aachen University and JARA-Institute Brain Structure Function Relationship (INM 10), Research Center Jülich and RWTH, Aachen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, BKH Augsburg, Dr.-Mack-Str. 1, 86156, Augsburg, Germany.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Salize', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meyer-Lindenberg', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Banaschewski', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schneider', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Habel', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Plener', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Benjamin Franklin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Wiechers', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, BKH Augsburg, Dr.-Mack-Str. 1, 86156, Augsburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Strupf', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, BKH Augsburg, Dr.-Mack-Str. 1, 86156, Augsburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jobst', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, BKH Augsburg, Dr.-Mack-Str. 1, 86156, Augsburg, Germany.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Millenet', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Hoehne', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilian University Munich, München, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Sukale', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Dinauer', 'Affiliation': 'Department of Social and Preventive Medicine, University of Potsdam, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schuster', 'Affiliation': 'Department of Social and Preventive Medicine, University of Potsdam, Germany.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Mehran', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Department of Psychiatry and Psychotherapy Rheinisch-Westfälische Technische Hochschule Aachen University and JARA-Institute Brain Structure Function Relationship (INM 10), Research Center Jülich and RWTH, Aachen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Bröcheler', 'Affiliation': 'Department of Psychiatry and Psychotherapy Rheinisch-Westfälische Technische Hochschule Aachen University and JARA-Institute Brain Structure Function Relationship (INM 10), Research Center Jülich and RWTH, Aachen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Lieb', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Mainz, Mainz, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Heinz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Psychosomatics and Psychotherapy, Faculty of Human Medicine, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Bajbouj', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Benjamin Franklin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]",The Lancet regional health. Europe,['10.1016/j.lanepe.2022.100413']
1752,35695058,The effects of music therapy on peripherally inserted central catheter in hospitalized children with leukemia.,"To explore the effect of music therapy on children with leukemia who have peripherally inserted central catheters (PICC).
In this study, we divided 107 patients undergoing PICC into music group (47 cases) and control group (60 cases). The music group received music therapy during PICC, while the control group was given no complementary treatment. The total length of catheterization, the use of sedatives and the changes of pain level and emotion level before and after PICC placement were compared between two groups.
Compared with the control group, the total PICC placement time of the music group was significantly shorter (35(30-40) vs. 60(60-60); Z = -8.307;  p  < 0.001), and the use of sedative medications was also significantly reduced (4.35% (n = 2) vs. 91.84% (n = 45);  p  < 0.001). Moreover, the pain of catheterization was significantly alleviated. The median difference of pain scores of the music group was significantly less (2(1-3) vs. 5(5-5);  p  < 0.001). The mood of patients was also improved. The median difference of emotional scores of the music group was significantly more (5(4.75-6) vs. 3(3-3);  p  < 0.001) than the control group.
Music therapy is effective to use in PICC. It can shorten the treatment time, reduce the use of sedative medications, and improve the children's emotion and pain response significantly, which is worth clinical application.",2022,The median difference of pain scores of the music group was significantly less (2(1-3) vs. 5(5-5);  p  < 0.001).,"['107 patients undergoing PICC into music group (47 cases) and control group (60 cases', 'children with leukemia who have peripherally inserted central catheters (PICC', 'hospitalized children with leukemia']","['Music therapy', 'music therapy']","['median difference of pain scores', ""children's emotion and pain response"", 'use of sedative medications', 'total PICC placement time', 'total length of catheterization, the use of sedatives and the changes of pain level and emotion level', 'median difference of emotional scores', 'pain of catheterization']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",107.0,0.0380287,The median difference of pain scores of the music group was significantly less (2(1-3) vs. 5(5-5);  p  < 0.001).,"[{'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shu-Zhen', 'Initials': 'SZ', 'LastName': 'Xu', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zheng-Yao', 'Initials': 'ZY', 'LastName': 'Guo', 'Affiliation': 'Music and Reflection, Inc, Guangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yan-Lai', 'Initials': 'YL', 'LastName': 'Tang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Li-Wei', 'Initials': 'LW', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Tang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhi-Ying', 'Initials': 'ZY', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}]",Journal of psychosocial oncology,['10.1080/07347332.2022.2044967']
1753,35695009,Effect of physical training on cytokine expression in CD4+ T lymphocytes in subjects with stable COPD.,"INTRODUCTION


Although evidence suggests that physical exercise reduces systemic inflammation, at the plasma level, there are still contradictions in chronic obstructive pulmonary disease (COPD). In this sense, analysis of intracellular cytokines could clear off the effect of physical exercise on the inflammatory profile of these subjects.
AIM


The aim was to evaluate the effect of physical training on cytokine expression in CD4+ T lymphocytes from subjects with COPD.
METHODS


This is a randomized controlled trial. Subjects with stable COPD were grouped into two groups, exercise and control. In total, 23 subjects with stable COPD were evaluated, of which 15 underwent aerobic strength training [physical exercise group (PEG)] and 8 underwent breathing exercises [respiratory physiotherapy group (RPG)]. Intracellular cytokines [interleukin (IL)-8, IL-13, IL-17, IL-6, IL-2, IL-10, and tumor necrosis factor alpha (TNF-α)] from CD4+ T lymphocytes were analyzed from peripheral blood through flow cytometry, before and after 8 weeks of intervention.
RESULTS


The PEG and RPG groups had a mean age of 68 ± 5.96 and 72.25 ± 6.86 years and predicted forced expiratory volume in the first second (FEV 1 ) of 58.6 ± 15.99% and 39.75 ± 10.39%, respectively. It was possible to detect a significant reduction in IL-8 ( p  = 0.0125) and an increase in IL-13 ( p  = 0.0014) and an increase in TNF-α ( p  < 0.001) in both groups.
CONCLUSION


Eight weeks of physical training, both peripheral and respiratory, were able to reduce concentrations of IL-8 and to increase IL-13, and TNF-α in CD4+ T lymphocytes in subjects with stable COPD. The findings reinforce the benefits of interventions in subjects with COPD, revealing data not previously investigated.",2022,"It was possible to detect a significant reduction in IL-8 ( p  = 0.0125) and an increase in IL-13 ( p  = 0.0014) and an increase in TNF-α ( p  < 0.001) in both groups.
","['subjects with COPD', '23 subjects with stable COPD', 'subjects with stable COPD', 'chronic obstructive pulmonary disease (COPD', 'Subjects with stable COPD', 'subjects with COPD.\nMETHODS']","['physical exercise', 'breathing exercises [respiratory physiotherapy group (RPG', 'aerobic strength training [physical exercise group (PEG', 'physical training']","['Intracellular cytokines [interleukin (IL)-8, IL-13, IL-17, IL-6, IL-2, IL-10, and tumor necrosis factor alpha (TNF-α)] from CD4+ T lymphocytes', 'cytokine expression in CD4+ T lymphocytes', 'TNF-α', 'IL-13', 'forced expiratory volume', 'concentrations of IL-8 and to increase IL-13, and TNF-α in CD4+ T lymphocytes', 'IL-8']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",23.0,0.0303886,"It was possible to detect a significant reduction in IL-8 ( p  = 0.0125) and an increase in IL-13 ( p  = 0.0014) and an increase in TNF-α ( p  < 0.001) in both groups.
","[{'ForeName': 'Juliana S', 'Initials': 'JS', 'LastName': 'Uzeloto', 'Affiliation': 'Department of Physiotherapy, Postgraduate Program in Physiotherapy, Faculty of Science and Technology, São Paulo State University (UNESP), Rua Roberto Simonsen, 305, Presidente Prudente, São Paulo 19060-900, Brazil.'}, {'ForeName': 'Alessandra C', 'Initials': 'AC', 'LastName': 'de Toledo-Arruda', 'Affiliation': 'Department of Physiology and Pharmacology, Laboratory of Exercise Sciences, Fluminense Federal University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bruna S A', 'Initials': 'BSA', 'LastName': 'Silva', 'Affiliation': 'Physiotherapy, Universidade Estadual Paulista Julio de Mesquita Filho, Presidente Prudente.'}, {'ForeName': 'Aline M M', 'Initials': 'AMM', 'LastName': 'Braz', 'Affiliation': 'Universidade Estadual Paulista Julio de Mesquita Filho.'}, {'ForeName': 'Fabiano F', 'Initials': 'FF', 'LastName': 'de Lima', 'Affiliation': 'Physiotherapy, Universidade Estadual Paulista Julio de Mesquita Filho, Presidente Prudente.'}, {'ForeName': 'Isis', 'Initials': 'I', 'LastName': 'Grigoletto', 'Affiliation': 'Physiotherapy, Universidade Estadual Paulista Julio de Mesquita Filho, Presidente Prudente.'}, {'ForeName': 'Dionei', 'Initials': 'D', 'LastName': 'Ramos', 'Affiliation': 'Physiotherapy, Universidade Estadual Paulista Julio de Mesquita Filho, Presidente Prudente.'}, {'ForeName': 'Marjorie A', 'Initials': 'MA', 'LastName': 'Golim', 'Affiliation': 'Botucatu Medical School, Postgraduate Program in Research & Development: Medical Biotechnology, Blood Center, Flow Cytometry Laboratory, São Paulo State University (UNESP), São Paulo, Brazil.'}, {'ForeName': 'Ercy M C', 'Initials': 'EMC', 'LastName': 'Ramos', 'Affiliation': 'Physiotherapy, Universidade Estadual Paulista Julio de Mesquita Filho, Presidente Prudente.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666221091179']
1754,35695006,"Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Stenosis: A Multicenter Randomized Phase II Trial.","BACKGROUND


Patients with symptomatic internal carotid artery (ICA) stenosis are at high risk of recurrent ischemic stroke and require early interventional treatment and antiplatelet therapy. Increased bleeding rates might counterbalance the periprocedural efficacy of intensified platelet inhibition. We aim to investigate, whether Revacept, a competitive antagonist of glycoprotein VI, adjunct to standard antiplatelet therapy reduces the occurrence of ischemic lesions in patients with symptomatic ICA stenosis.
METHODS


International, multicenter (16 sites), 3-arm, randomized (1:1:1), double-blind, and placebo-controlled study with parallel groups, including patients with symptomatic ICA stenosis. A single infusion over 20 minutes of either placebo, 40 mg or 120 mg Revacept in addition to guideline-conform antiplatelet therapy was evaluated with regard to the exploratory efficacy end point: Number of new ischemic lesions on diffusion-weighted magnetic resonance imaging after treatment initiation. Main clinical outcome was the combined safety and efficacy end point including any stroke or death, transient ischemic attack, myocardial infarction, coronary intervention, and bleeding complications during follow-up.
RESULTS


Out of 160 randomized patients, 158 patients (68±10.1 years, 24% female) received study medication (51 patients placebo, 54 patients 40 mg Revacept and 53 patients 120 mg Revacept) and were followed for 11.2±2.3 months. A total of 1.16 (95% CI, 0.88-1.53)/1.05 (95% CI, 0.78-1.42;  P =0.629)/0.63 (95% CI, 0.43-0.93) new diffusion-weighted magnetic resonance imaging lesions per patient were detected in the placebo/40 mg/120 mg Revacept groups, without statistical evidence of a difference. A reduction of the combined safety and efficacy end point during the study period was observed in patients who received 120 mg (HR, 0.46 [95% CI, 0.21-0.99];  P =0.047), but not 40 mg Revacept compared with placebo (HR, 0.72 [95% CI, 0.37-1.42];  P =0.343).
CONCLUSIONS


Revacept 120 mg reduced the combined safety and efficacy end point in patients with symptomatic ICA stenosis.
REGISTRATION


URL: https://www.
CLINICALTRIALS


gov; Unique Identifier: NCT01645306.",2022,"Main clinical outcome was the combined safety and efficacy end point including any stroke or death, transient ischemic attack, myocardial infarction, coronary intervention, and bleeding complications during follow-up.
","['Out of 160 randomized patients, 158 patients (68±10.1 years, 24% female) received study medication (51 patients', 'patients with symptomatic ICA stenosis', 'Symptomatic Carotid Stenosis', 'Patients with symptomatic internal carotid artery (ICA) stenosis']",['placebo'],"['occurrence of ischemic lesions', 'combined safety and efficacy', 'bleeding rates', 'combined safety and efficacy end point including any stroke or death, transient ischemic attack, myocardial infarction, coronary intervention, and bleeding complications during follow-up']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0340569', 'cui_str': 'Internal carotid artery stenosis'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",160.0,0.40324,"Main clinical outcome was the combined safety and efficacy end point including any stroke or death, transient ischemic attack, myocardial infarction, coronary intervention, and bleeding complications during follow-up.
","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Uphaus', 'Affiliation': 'Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Germany (T.U., K.G.).'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Richards', 'Affiliation': 'Department of Vascular Surgery, University of Western Australia, Fiona Stanley Hospital, Perth, Australia (T.R.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Weimar', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University Hospital, University Duisburg-Essen, Essen, Germany and BDH-clinic Elzach, Germany (C.W.).'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Neugebauer', 'Affiliation': 'Department of Neurology, University Hospital Würzburg, Germany (H.N.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Poli', 'Affiliation': 'Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, Eberhard-Karls University Tübingen, Germany (S.P.).'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Weissenborn', 'Affiliation': 'Department of Neurology, Hannover Medical School, Germany (K.W.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Imray', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, United Kingdom (C.I.).'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Michalski', 'Affiliation': 'Department of Neurology, University of Leipzig, Germany (D.M.).'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Rashid', 'Affiliation': ""Department of Vascular Surgery, King's College Hospital, London, United Kingdom (H.R.).""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Loftus', 'Affiliation': ""St George's Vascular Institute, St George's Hospital NHS Foundation Trust, London, United Kingdom (I.L.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rummey', 'Affiliation': 'Clinical Data Science GmbH, Basel, Switzerland (C.R.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ritter', 'Affiliation': 'Physicians Centre at the Principal Market, Muenster, Germany (M.R.).'}, {'ForeName': 'Till-Karsten', 'Initials': 'TK', 'LastName': 'Hauser', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, University Hospital Tübingen, Germany (T.-K.H.).'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Münch', 'Affiliation': 'AdvanceCOR, Martinsried, Germany (G.M.).'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gröschel', 'Affiliation': 'Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Germany (T.U., K.G.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Poppert', 'Affiliation': 'Department of Neurology, Helios Klinikum München West, Germany (H.P.).'}]",Stroke,['10.1161/STROKEAHA.121.037006']
1755,35694970,A randomized controlled study of the effect of functional exercises on postural kyphosis: Schroth-based three-dimensional exercises versus postural corrective exercises.,"PURPOSE


To compare the effects of postural corrective and Schroth-based three-dimensional exercises on thoracic kyphosis angle (TKA), lumbar lordosis angle (LLA), balance and quality of life (QoL) in individuals with postural kyphosis.
METHODS


This was a single-blind randomized controlled clinical trial with a total of 63 subjects (57 women, 6 men) with TKA of  ≥ 40°. Subjects were separated into three groups: postural corrective exercise group (PCEG), Schroth-based three-dimensional exercise group (SBEG) and control group (CG). Participants in the exercise groups participated in the exercise program twice a week for eight weeks under the supervision of a physiotherapist: CG performed no exercise but was generally informed. The primary outcome variable was TKA. Secondary outcome variables were LLA, balance and QoL.
RESULTS


After the functional exercise programs, TKA (mean change for PCEG, SBEG: -9.71, -14.76,  p  < 0.001), static postural stability index overall (-0.22, -0.40,  p  < 0.05), and QoL (-0.41, -0.37,  p  < 0.001) significantly improved in both training groups compared with CG. The LLA (-3.95,  p  = 0.003) was significantly lower in the SBEG group than in CG.
CONCLUSION


This study demonstrated that Schroth-based three-dimensional exercises are an effective treatment for individuals with postural kyphosis and have a large effect size that improves TKA, LLA, balance and QoL.  Clinical trial registration number:  NCT03706495 Implications for rehabilitationEight weeks of postural corrective or Schroth-based three-dimensional functional exercise programs are effective in addressing thoracic kyphosis angle (TKA), balance, and quality of life in individuals with postural kyphosis.An eight-week Schroth-based three-dimensional exercise program was more effective than postural corrective exercises in improving TKA, lumbar lordosis angle, and balance for patients with postural kyphosis.Schroth-based three-dimensional exercise programs could promote balance and spinal health in young adults with thoracic kyphosis.",2022,"This study demonstrated that Schroth-based three-dimensional exercises are an effective treatment for individuals with postural kyphosis and have a large effect size that improves TKA, LLA, balance and QoL.  Clinical trial registration number:  NCT03706495 Implications for rehabilitationEight weeks of postural corrective or Schroth-based three-dimensional functional exercise programs are effective in addressing thoracic kyphosis angle (TKA), balance, and quality of life in individuals with postural kyphosis.","['patients with postural kyphosis', 'individuals with postural kyphosis', '63 subjects (57 women, 6 men) with TKA of  ≥ 40°', 'young adults with thoracic kyphosis']","['postural corrective exercise group (PCEG), Schroth-based three-dimensional exercise group (SBEG) and control group (CG', 'postural corrective or Schroth-based three-dimensional functional exercise programs', 'SBEG', 'postural corrective and Schroth-based three-dimensional exercises', 'postural corrective exercises', 'Schroth-based three-dimensional exercise programs', 'exercise program', 'Schroth-based three-dimensional exercises', 'functional exercises', 'dimensional exercises versus postural corrective exercises']","['TKA', 'QoL', 'balance and spinal health', 'thoracic kyphosis angle (TKA), lumbar lordosis angle (LLA), balance and quality of life (QoL', 'LLA, balance and QoL', 'static postural stability index overall']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392048', 'cui_str': 'Postural kyphosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1184923', 'cui_str': 'Lumbar hyperlordosis'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",63.0,0.0477537,"This study demonstrated that Schroth-based three-dimensional exercises are an effective treatment for individuals with postural kyphosis and have a large effect size that improves TKA, LLA, balance and QoL.  Clinical trial registration number:  NCT03706495 Implications for rehabilitationEight weeks of postural corrective or Schroth-based three-dimensional functional exercise programs are effective in addressing thoracic kyphosis angle (TKA), balance, and quality of life in individuals with postural kyphosis.","[{'ForeName': 'Sena', 'Initials': 'S', 'LastName': 'Özdemir Görgü', 'Affiliation': 'Department \xa0of Physical Therapy and Rehabilitation, Institute of Health Sciences, Istanbul Medipol Universty, Istanbul, Turkey.'}, {'ForeName': 'Zeliha C', 'Initials': 'ZC', 'LastName': 'Algun', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, School of Health Sciences, Istanbul Medipol Universty, Istanbul, Turkey.'}]",Disability and rehabilitation,['10.1080/09638288.2022.2083244']
1756,35694969,Esophageal thermal lesions in radiofrequency ablation for atrial fibrillation: a prospective comparative study of thermal sensors.,"BACKGROUND


Esophageal thermal lesion (ETL) is a complication of radiofrequency ablation for atrial fibrillation (RFAF). To prospectively compare the incidence of ETL, we used two linear, five- and three-sensor esophageal thermal monitoring catheters (ETMC5 and ETMC3). We also evaluated the predictors of ETL.
METHODS


Patients receiving their first RFAF (n = 106) were randomized into two groups, ETMC5 (n = 52) and ETMC3 (n = 54). Ablation was followed by esophagogastroduodenoscopy within 3 days.
RESULTS


ETL was detected in 7/106 (6.6%) patients (ETMC5: 4/54 [7.4%]; ETMC3: 3/52 [5.8%]). The maximum temperature and number of measurements >39.0°C did not differ between the groups (ETMC5: 40.4°C and 5.4 vs. ETMC3: 40.5°C and 4.9; P = 0.83 and P = 0.58, respectively). In ETMC5 group, the catheter had to be moved significantly less often (0.12 vs. 0.42; P = 0.0014) and fluoroscopy time was significantly shorter (79.2 min vs. 101.7 min; P = 0.0038) compared with ECMC3 group. The total number of ablations in ETMC5 group was significantly greater (50.2 vs. 37.7; P = 0.026) and ablation time was significantly longer (52.1 min vs. 40.1 min; P = 0.0039). Only body mass index (BMI) was significantly different between patients with and without ETL (21.4 ± 2.5 vs. 24.3 ± 3.4; P = 0.022).
CONCLUSIONS


The incidence of ETL was comparable between ETMC5 and ETMC3 groups; however, fluoroscopy time, total ablation time, and total number of ablations differed significantly. Lower BMI may increase the risk of developing ETL. This article is protected by copyright. All rights reserved.",2022,The total number of ablations in ETMC5 group was significantly greater (50.2 vs. 37.7; P = 0.026) and ablation time was significantly longer (52.1 min vs. 40.1 min; P = 0.0039).,"['Patients receiving their first RFAF (n = 106', 'atrial fibrillation']","['ETMC5', 'esophageal thermal monitoring catheters (ETMC5 and ETMC3', 'radiofrequency ablation', 'ETMC3', 'ECMC3']","['maximum temperature and number of measurements >39.0°C', 'ablation time', 'body mass index (BMI', 'incidence of ETL', 'risk of developing ETL', 'fluoroscopy time', 'fluoroscopy time, total ablation time, and total number of ablations', 'total number of ablations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",106.0,0.0208867,The total number of ablations in ETMC5 group was significantly greater (50.2 vs. 37.7; P = 0.026) and ablation time was significantly longer (52.1 min vs. 40.1 min; P = 0.0039).,"[{'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Arai', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Kanto Rosai Hospital.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Sugiyama', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Gokan', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Yoshikawa', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Inokuchi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Chiba', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Onishi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Onuki', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Asano', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Medical Safety, Showa University Hospital.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Shinke', 'Affiliation': 'Division of Cardiology, Department of Medicine, Showa University School of Medicine.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14551']
1757,35694945,Effects of an active hand exoskeleton on forearm muscle activity in industrial assembly grips.,"BACKGROUND


The Bioservo Ironhand ® is a commercially available active hand exoskeleton for reducing grip-induced stress.
OBJECTIVES


The study aimed at quantifying the effect of the Ironhand ® exoskeleton on the myoelectric muscle activity of forearm flexor and extensor muscles in three relevant assembly grip tasks: 2-Finger-grip (2Finger), 5-Finger-grip (5Finger) and Full grip (FullGrip).
METHODS


Twenty-two subjects were tested in three different exoskeleton conditions for each grip task (overall 3×3×10 = 90 repetitions in randomized order): Exoskeleton off (Off), Exoskeleton on, ""locking tendency"" 0% (On_LT0), and Exoskeleton on, ""locking tendency"" 85% (On_LT85). Muscle activity was measured at 25% of the participant's maximum grip force using two EMG sensors at the M. flexor digitorum superficialis (M.FDS) and one at the M. extensor digitorum (M.ED).
RESULTS


The effect of the Ironhand ® exoskeleton varied depending on the grip task and the participant's sex. A statistically significant reduction in muscle activity of the M.FDS was found only for male subjects in the FullGrip condition. No reduction of muscular activity in the M.FDS was found for the other grip tasks (2Finger, 5Finger). For the females in the 2Finger condition, mean muscle activity of M.FDS even increased significantly in On_LT0 compared to Off. Besides differences between grip tasks and sex, the current study revealed substantial individual differences.
CONCLUSIONS


In addition to testing for statistical significance, a detailed exploratory analysis of exoskeleton effects at subject level should be performed to evaluate these from a safety and regulatory perspective.",2022,A statistically significant reduction in muscle activity of the M.FDS was found only for male subjects in the FullGrip condition.,"['Twenty-two subjects were tested in three different exoskeleton conditions for each grip task (overall 3×3×10\u200a=\u200a90 repetitions in randomized order', 'male subjects in the FullGrip condition', 'industrial assembly grips']","['Ironhand\xa0® exoskeleton', 'active hand exoskeleton']","['muscle activity of the M.FDS', 'muscular activity', 'grip (2Finger), 5-Finger-grip (5Finger) and Full grip (FullGrip', 'forearm muscle activity', 'mean muscle activity of M.FDS', 'Muscle activity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021267', 'cui_str': 'Industry'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224258', 'cui_str': 'Structure of flexor digitorum superficialis muscle of hand'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0441976', 'cui_str': '2 fingers'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C1760774', 'cui_str': 'Structure of muscle of forearm'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",22.0,0.0554319,A statistically significant reduction in muscle activity of the M.FDS was found only for male subjects in the FullGrip condition.,"[{'ForeName': 'Tobias A', 'Initials': 'TA', 'LastName': 'Mayer', 'Affiliation': 'Professorship of Research Methodology and Data Analysis in Biomechanics, Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Harsch', 'Affiliation': 'Professorship of Research Methodology and Data Analysis in Biomechanics, Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Koska', 'Affiliation': 'Professorship of Research Methodology and Data Analysis in Biomechanics, Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Hensel-Unger', 'Affiliation': 'Audi AG, Ingolstadt, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Maiwald', 'Affiliation': 'Professorship of Research Methodology and Data Analysis in Biomechanics, Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}]","Work (Reading, Mass.)",['10.3233/WOR-211272']
1758,35694933,Evaluating the Use of Digital Biomarkers to Test Treatment Effects on Cognition and Movement in Patients with Lewy Body Dementia.,"BACKGROUND


PRESENCE was a Phase 2 trial assessing mevidalen for symptomatic treatment of Lewy body dementia (LBD). Participants received daily doses (10, 30, or 75 mg) of mevidalen (LY3154207) or placebo for 12 weeks.
OBJECTIVE


To evaluate if frequent cognitive and motor tests using an iPad app and wrist-worn actigraphy to track activity and sleep could detect mevidalen treatment effects in LBD.
METHODS


Of 340 participants enrolled in PRESENCE, 238 wore actigraphy for three 2-week periods: pre-, during, and post-intervention. A subset of participants (n = 160) enrolled in a sub-study using an iPad trial app with 3 tests: digital symbol substitution (DSST), spatial working memory (SWM), and finger-tapping. Compliance was defined as daily test completion or watch-wearing ≥23 h/day. Change from baseline to week 12 (app) or week 8 (actigraphy) was used to assess treatment effects using Mixed Model Repeated Measures analysis. Pearson correlations between sensor-derived features and clinical endpoints were assessed.
RESULTS


Actigraphy and trial app compliance was >  90% and >  60%, respectively. At baseline, daytime sleep positively correlated with Epworth Sleepiness Scale score (p <  0.01). Physical activity correlated with improvement on Movement Disorder Society -Unified Parkinson Disease Rating Scale (MDS-UPDRS) part II (p <  0.001). Better scores of DSST and SWM correlated with lower Alzheimer Disease Assessment Scale -Cognitive 13-Item Scale (ADAS-Cog13) (p <  0.001). Mevidalen treatment (30 mg) improved SWM (p <  0.01), while dose-dependent decreases in daytime sleep (10 mg: p <  0.01, 30 mg: p <  0.05, 75 mg: p <  0.001), and an increase in walking minutes (75 mg dose: p <  0.001) were observed, returning to baseline post-intervention.
CONCLUSION


Devices used in the LBD population achieved adequate compliance and digital metrics detected statistically significant treatment effects.",2022,"Mevidalen treatment (30 mg) improved SWM (p <  0.01), while dose-dependent decreases in daytime sleep (10 mg: p <  0.01, 30 mg: p <  0.05, 75 mg: p <  0.001), and an increase in walking minutes (75 mg dose: p <  0.001) were observed, returning to baseline post-intervention.
","['Lewy body dementia (LBD', 'Patients with Lewy Body Dementia', 'A subset of participants (n\u200a=\u200a160) enrolled in a sub-study using an iPad trial app with 3 tests', 'Of 340 participants enrolled in PRESENCE, 238 wore actigraphy for three 2-week periods: pre-, during, and post-intervention']","['digital symbol substitution (DSST), spatial working memory (SWM), and finger-tapping', 'mevidalen (LY3154207) or placebo']","['Cognition and Movement', 'walking minutes', 'Movement Disorder Society -Unified Parkinson Disease Rating Scale (MDS-UPDRS', 'lower Alzheimer Disease Assessment Scale -Cognitive 13-Item Scale (ADAS-Cog13', 'daytime sleep', 'Physical activity', 'Epworth Sleepiness Scale score', 'SWM']","[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",340.0,0.0742087,"Mevidalen treatment (30 mg) improved SWM (p <  0.01), while dose-dependent decreases in daytime sleep (10 mg: p <  0.01, 30 mg: p <  0.05, 75 mg: p <  0.001), and an increase in walking minutes (75 mg dose: p <  0.001) were observed, returning to baseline post-intervention.
","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Chakib', 'Initials': 'C', 'LastName': 'Battioui', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McCarthy', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Xiangnan', 'Initials': 'X', 'LastName': 'Dang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Man', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kyle', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Munsie', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pugh', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Biglan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-213126']
1759,35695264,MicroRNA-9-3p: a novel predictor of neurological outcome after cardiac arrest.,"AIMS


Resuscitated out-of-hospital cardiac arrest (OHCA) patients who remain comatose after hospital arrival are at high risk of mortality due to anoxic brain injury. MicroRNA are small-non-coding RNA molecules ultimately involved in gene-silencing. They show promise as biomarkers, as they are stable in body fluids. The microRNA 9-3p (miR-9-3p) is associated with neurological injury in trauma and subarachnoid haemorrhage.
METHODS AND RESULTS


This post hoc analysis considered all 171 comatose OHCA patients from a single centre in the target temperature management (TTM) trial. Patients were randomized to TTM at either 33°C or 36°C for 24 h. MicroRNA-9-3p (miR-9-3p) was measured in plasma sampled at admission and at 28, 48, and 72 h. There were no significant differences in age, gender, and pre-hospital data, including lactate level at admission, between miR-9-3p level quartiles. miR-9-3p levels changed markedly following OHCA with a peak at 48 h. Median miR-9-3p levels between TTM 33°C vs. 36°C were not different at any of the four time points. Elevated miR-9-3p levels at 48 h were strongly associated with an unfavourable neurological outcome [OR: 2.21, 95% confidence interval (CI): 1.64-3.15, P < 0.0001). MiR-9-3p was inferior to neuron-specific enolase in predicting functional neurological outcome [area under the curve: 0.79 (95% CI: 0.71-0.87) vs. 0.91 (95% CI: 0.85-0.97)].
CONCLUSION


MiR-9-3p is strongly associated with neurological outcome following OHCA, and the levels of miR-9-3p are peaking 48 hours following cardiac arrest.",2022,"Elevated miR-9-3p levels at 48 h were strongly associated with an unfavourable neurological outcome [OR: 2.21, 95% confidence interval (CI): 1.64-3.15, P < 0.0001).","['hospital cardiac arrest (OHCA) patients who remain comatose after hospital arrival are at high risk of mortality due to anoxic brain injury', '171 comatose OHCA patients from a single centre in the target temperature management (TTM) trial']",['TTM'],['Elevated miR-9-3p levels'],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0003132', 'cui_str': 'Anoxic encephalopathy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040953', 'cui_str': 'Trichotillomania'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3884166', 'cui_str': 'MIRN9 microRNA, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.243773,"Elevated miR-9-3p levels at 48 h were strongly associated with an unfavourable neurological outcome [OR: 2.21, 95% confidence interval (CI): 1.64-3.15, P < 0.0001).","[{'ForeName': 'Rasmus Paulin', 'Initials': 'RP', 'LastName': 'Beske', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Bache', 'Affiliation': 'Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Abild Stengaard Meyer', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjærgaard', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bro-Jeppesen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Laust', 'Initials': 'L', 'LastName': 'Obling', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Markus Harboe', 'Initials': 'MH', 'LastName': 'Olsen', 'Affiliation': 'Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rossing', 'Affiliation': 'Centre for Genomic Medicine, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Finn Cilius', 'Initials': 'FC', 'LastName': 'Nielsen', 'Affiliation': 'Centre for Genomic Medicine, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Møller', 'Affiliation': 'Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Sciences at Helsingborg, Lund University, Lund, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.'}]",European heart journal. Acute cardiovascular care,['10.1093/ehjacc/zuac066']
1760,35695234,Telephone coaching for the prevention of depression in depression in farmers: Results from a pragmatic from a pragmatic randomized controlled trial.,"INTRODUCTION


Farmers have a high risk for depression (MDD). Preventive measures targeting this often remotely living population might reduce depression burden. The study aimed to evaluate the effectiveness of personalized telephone coaching in reducing depressive symptom severity and preventing MDD in farmers compared to enhanced treatment as usual (TAU + ).
METHODS


In a two-armed, pragmatic randomized controlled trial ( N  = 314) with post-treatment at 6 months, farming entrepreneurs, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) were randomized to personalized telephone coaching or TAU + . The coaching was provided by psychologists and consists on average of 13 (±7) sessions a 48 min (±15) over 6 months. The primary outcome was depressive symptom severity (QIDS-SR16).
RESULTS


Coaching participants showed a significantly greater reduction in depressive symptom severity compared to TAU + ( d  = 0.39). Whereas reliable symptom deterioration was significantly lower in the intervention group compared to TAU + , no significant group differences were found for reliable improvement and in depression onset. Further significant effects in favor of the intervention group were found for stress ( d  = 0.34), anxiety ( d  = 0.30), somatic symptoms ( d  = 0.39), burnout risk ( d  = 0.24-0.40) and quality of life ( d  = 0.28).
DISCUSSION


Limiting, we did not apply an upper cutoff score for depressive symptom severity or controlled for previous MDD episodes, leaving open whether the coaching was recurrence/relapse prevention or early treatment. Nevertheless, personalized telephone coaching can effectively improve mental health in farmers. It could play an important role in intervening at an early stage of mental health problems and reducing disease burden related to MDD.
TRIAL REGISTRATION NUMBER AND TRIAL REGISTER


German Clinical Trial Registration: DRKS00015655.",2022,"Whereas reliable symptom deterioration was significantly lower in the intervention group compared to TAU + , no significant group differences were found for reliable improvement and in depression onset.","['family members and pensioners with elevated depressive symptoms (PHQ-9\u2009≥\u20095', 'farmers', 'depression in depression in farmers']","['Telephone coaching', 'personalized telephone coaching or TAU\u2009+\u2009', 'personalized telephone coaching']","['depression onset', 'depressive symptom severity (QIDS-SR16', 'depressive symptom severity', 'reliable symptom deterioration', 'quality of life', 'somatic symptoms', 'mental health', 'anxiety']","[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",314.0,0.208518,"Whereas reliable symptom deterioration was significantly lower in the intervention group compared to TAU + , no significant group differences were found for reliable improvement and in depression onset.","[{'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Thielecke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, 9171Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Buntrock', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, 9171Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, 9171Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Braun', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, 9189Ulm University, Ulm, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freund', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, 9171Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Berking', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, 9171Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, 9189Ulm University, Ulm, Germany.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Professorship of Psychology and Digital Mental Health Care, 9184Technical University of Munich, Munich, Germany.'}]",Journal of telemedicine and telecare,['10.1177/1357633X221106027']
1761,35695227,The effect of gestational diabetes mellitus on occurrence of the pelvic girdle pain and symptom severity in pregnant women.,"The primary objective of this study was to examine the effect of gestational diabetes mellitus (GDM) on pelvic girdle pain (PGP) occurrence and symptom severity. Pregnant women who were with/without GDM, 20-40 years of age, and also in the second and third trimesters of pregnancy were included in the study. PGP provocation tests were administered to 187 pregnant women to determine the presence and severity of PGP. Based on the test results, the study subjects were divided into two groups; Group 1 (GDM+, PGP+; n:32) and Group 2 (GDM-, PGP+; n:35). Both groups were asked to fill in the Pelvic Girdle Questionnaire (PGQ). The relationship between the presence of GDM and the presence of PGP was found to be significant ( p  = .043). It was found the groups were similar in view of pain, and also in PGQ total/subscale scores ( p  > .05). Although GDM has no effect on symptom severity, it has been determined that it may relate to the development of PGP. Therefore, early interventions (nutrition, exercise, belt using, etc.) are recommended to prevent the development of PGP in pregnant women with a family history of diabetes, with a previous diagnosis of diabetes and/or with GDM detected in their previous pregnancies.  Clinical Trial Number:  04769375Impact of Statement What is already known on this subject?  Gestational diabetes mellitus and pelvic girdle pain are pathologies that develops secondary to pregnancy-related systemic and biomechanical changes. What do results on this study add?  GDM may related the development of PGP. What are the implications of these findings for clinical practice and/or further research?  Early interventions (nutrition, exercise, belt using, etc.) and strict control of pregnant women in view of PGP is recommended to prevent the development of PGP in pregnant women with a family history of diabetes, with previous diagnosis of diabetes and/or with GDM detected in their previous pregnancies. The evaluation of pregnant women for PGP before administering interventions, such as exercise and diet (both decrease the pro-inflammatory markers), following the diagnosis of GDM and the measurement of plasma anti- and pro-inflammatory marker values in the same time period will further reveal the relationship between GDM and PGP.",2022,"It was found the groups were similar in view of pain, and also in PGQ total/subscale scores ( p  > .05).","['pregnant women with a family history of diabetes, with previous diagnosis of diabetes and/or with GDM detected in their previous pregnancies', 'pregnant women', 'Pregnant women who were with/without GDM, 20-40\u2009years of age, and also in the second and third trimesters of pregnancy were included in the study', '187 pregnant women', 'pregnant women with a family history of diabetes, with a previous diagnosis of diabetes and/or with GDM detected in their previous pregnancies']","['gestational diabetes mellitus (GDM', 'GDM']","['Pelvic Girdle Questionnaire (PGQ', 'pelvic girdle pain and symptom severity', 'pelvic girdle pain (PGP) occurrence and symptom severity', 'PGQ total/subscale scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1313937', 'cui_str': 'Family history of diabetes mellitus'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517618', 'cui_str': '187'}]","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0684083', 'cui_str': 'Structure of pelvic girdle'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0240682', 'cui_str': 'Pelvic girdle pain'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",187.0,0.0173969,"It was found the groups were similar in view of pain, and also in PGQ total/subscale scores ( p  > .05).","[{'ForeName': 'Nilüfer', 'Initials': 'N', 'LastName': 'Kablan', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, İstanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Habibe', 'Initials': 'H', 'LastName': 'Ayvacı', 'Affiliation': 'Ministry of Health, Zeynep Kamil Women and Pediatric Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Can', 'Affiliation': 'Plato Vocational School, Department of Physiotherapy and Rehabilitation, Ayvansaray University, Istanbul, Turkey.'}, {'ForeName': 'Yaşar', 'Initials': 'Y', 'LastName': 'Tatar', 'Affiliation': 'Faculty of Sports Sciences, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Kumru', 'Affiliation': 'Ministry of Health, Zeynep Kamil Women and Pediatric Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sadık', 'Initials': 'S', 'LastName': 'Şahin', 'Affiliation': 'Ministry of Health, Zeynep Kamil Women and Pediatric Training and Research Hospital, Istanbul, Turkey.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2022.2081491']
1762,35695215,Long-term disease control and safety with the anti-CCR4 antibody mogamulizumab: post-hoc analyses from the MAVORIC trial of patients with previously treated cutaneous T-cell lymphoma.,,2022,,['patients with previously treated cutaneous T-cell lymphoma'],['anti-CCR4 antibody mogamulizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0079773', 'cui_str': 'Cutaneous T-cell lymphoma'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C2987603', 'cui_str': 'mogamulizumab'}]",[],,0.0792808,,"[{'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Bagot', 'Affiliation': 'Hôpital Saint Louis, APHP, Inserm U976, Université Paris Cité, Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon, Claude Bernard Lyon 1 University, Lyon, France.'}, {'ForeName': 'Lubomir', 'Initials': 'L', 'LastName': 'Sokol', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Athansios', 'Initials': 'A', 'LastName': 'Tsianakas', 'Affiliation': 'Specialist Clinic Bad Bentheim, Bad Bentheim, Germany.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Musiek', 'Affiliation': 'Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Pablo L', 'Initials': 'PL', 'LastName': 'Ortiz-Romero', 'Affiliation': 'Department of Dermatology, Institute i+12, Hospital 12 de Octubre Medical School, University Complutense Madrid, Madrid, Spain.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Poligone', 'Affiliation': 'Rochester Skin Lymphoma Center, Fairport, NY, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Duvic', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Elmets', 'Affiliation': 'University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Leoni', 'Affiliation': 'Kyowa Kirin, Inc., Princeton, NJ, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dwyer', 'Affiliation': 'Kyowa Kirin, Inc., Princeton, NJ, USA.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Kyowa Kirin, Inc., Princeton, NJ, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Herr', 'Affiliation': 'Kyowa Kirin, Inc., Bedminster, NJ, USA.'}, {'ForeName': 'Youn H', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}]",Dermatologic therapy,['10.1111/dth.15634']
1763,35695197,Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial.,"Background.  Up to 85% of people with chronic stroke experience somatosensory impairment, which contributes to poor sensorimotor control and non-use of the affected limb. Neurophysiological mechanisms suggest motor rehabilitation may improve tactile sense post-stroke, however, somatosensory recovery has rarely been reported in controlled trials.  Objective.  To compare the effect of four upper limb motor rehabilitation programs on the recovery of tactile sensation in adults with chronic stroke.  Methods.  Adults with chronic stroke and mild or moderate upper extremity hemiparesis ( n  = 167) were enrolled in a multi-site randomized controlled trial. Participants completed three weeks of gaming therapy, gaming therapy with additional telerehabilition, Constraint-Induced Movement therapy, or traditional rehabilitation. Here, we report the results of a secondary outcome, tactile sensation, measured with monofilaments, before and after treatment, and 6 months later.  Results.  A mixed-effects general linear model revealed similar positive change in tactile sensitivity regardless of the type of training. On average, participants were able to detect a stimulus that was 32% and 33% less after training and at 6-month follow-up, respectively. One-third of participants experienced recategorization of their level of somatosensory impairment (e.g., regained protective sensation) following training. Poorer tactile sensation at baseline was associated with greater change.  Conclusions.  About one-third of individuals with mild/moderate chronic hemiparesis experience sustained improvements in tactile sensation following motor rehabilitation, regardless of the extent of tactile input in the rehabilitation program. Potential for sensory improvement is an additional motivator for those post-stroke. Characteristics of those who improve and mechanisms of improvement are important future questions. Clinicaltrials.gov NCT02631850.",2022,"About one-third of individuals with mild/moderate chronic hemiparesis experience sustained improvements in tactile sensation following motor rehabilitation, regardless of the extent of tactile input in the rehabilitation program.","['Chronic Stroke', 'Adults with chronic stroke and mild or moderate upper extremity hemiparesis ( n  = 167', 'adults with chronic stroke']","['four upper limb motor rehabilitation programs', 'Motor Rehabilitation', 'gaming therapy, gaming therapy with additional telerehabilition, Constraint-Induced Movement therapy, or traditional rehabilitation']","['Poorer tactile sensation', 'recategorization of their level of somatosensory impairment (e.g., regained protective sensation', 'tactile sensation', 'Tactile Sensation']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C4517595', 'cui_str': '167'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0454421', 'cui_str': 'Games for therapy'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0702221', 'cui_str': 'Touch sensation, function'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",167.0,0.0818326,"About one-third of individuals with mild/moderate chronic hemiparesis experience sustained improvements in tactile sensation following motor rehabilitation, regardless of the extent of tactile input in the rehabilitation program.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Borstad', 'Affiliation': 'Department of Physical Therapy, 3031College of St. Scholastica, Duluth, MN, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Nichols-Larsen', 'Affiliation': 'School of Health and Rehabilitation Sciences, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Gitendra', 'Initials': 'G', 'LastName': 'Uswatte', 'Affiliation': 'Department of Psychology, University of Alabama Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Strahl', 'Affiliation': 'Stroke Survivor, Medford, OR, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Simeo', 'Affiliation': 'Ohio Health, Columbus, OH, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Proffitt', 'Affiliation': 'Department of Occupational Therapy, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Gauthier', 'Affiliation': 'Department Physical Therapy and Kinesiology, 14710University of Massachusetts Lowell, Lowell, MA, USA.'}]",Neurorehabilitation and neural repair,['10.1177/15459683221107893']
1764,35699398,Clinical application of dexmedetomidine combined with dezocine in local anesthesia for endoscopic dacryocystorhinostomy.,"OBJECTIVE


To investigate the clinical effect of dexmedetomidine combined with dezocine in local anesthesia for endoscopic dacryocystorhinostomy (DCR).
METHODS


Ninety patients undergoing elective endoscopic DCR were randomly divided into two groups, local anesthesia group (LA group n = 45) and general anesthesia group (GA group, n = 45). These subjects were all American Society of Anesthesiologists (ASA)-Physical Status I-II patients. The changes of mean arterial pressure (MAP) and heart rate (HR) were observed and recorded before anesthesia (T0), after anesthesia (T1), at the beginning of surgery (T2), and at the end of surgery (T3). The visual analogue scale (VAS) score was observed and recorded immediately after awakening from anesthesia and at 1, 2, 6, and 12 h after surgery. Additionally, the occurrence of adverse reactions after surgery and the sedation-agitation scale (SAS) score after awakening were recorded.
RESULTS


Compared with the LA group, the MAP and HR of the GA group were significantly lower at T1 and T2, but significantly higher at T3. Local anesthesia was associated with lower VAS score immediately after awakening and at 1, 2, 6, and 12 h after surgery. Also, local anesthesia caused a lower incidence of postoperative agitation, nausea, and vomiting. The SAS score in the LA group was markedly higher than that in the GA group.
CONCLUSION


Local anesthesia with dexmedetomidine and dezocine as adjuvants in endoscopic DCR has more stable hemodynamics and reduces the stress response during perioperative period. Also, this anesthesia achieves better postoperative sedation and analgesia effects, reduces postoperative complications, and improves the quality of awakening from anesthesia. Collectively, local anesthesia is a comfortable and safe option for patients with high risks of general anesthesia and those unwilling to receive general anesthesia.",2022,"Local anesthesia was associated with lower VAS score immediately after awakening and at 1, 2, 6, and 12 h after surgery.","['patients with high risks of general anesthesia and those unwilling to receive general anesthesia', 'subjects were all American Society of Anesthesiologists (ASA)-Physical Status I-II patients', 'Ninety patients undergoing elective endoscopic DCR', 'local anesthesia for endoscopic dacryocystorhinostomy']","['LA', 'dexmedetomidine and dezocine', 'dezocine', 'dexmedetomidine', 'local anesthesia group (LA group n = 45) and general anesthesia group (GA']","['quality of awakening from anesthesia', 'SAS score', 'sedation-agitation scale (SAS) score', 'VAS score', 'stress response', 'mean arterial pressure (MAP) and heart rate (HR', 'postoperative complications', 'occurrence of adverse reactions', 'postoperative agitation, nausea, and vomiting', 'postoperative sedation and analgesia effects', 'visual analogue scale (VAS) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0558080', 'cui_str': 'Unwilling'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0395256', 'cui_str': 'Intranasal dacryocystorhinostomy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0057626', 'cui_str': 'dezocine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",90.0,0.0207403,"Local anesthesia was associated with lower VAS score immediately after awakening and at 1, 2, 6, and 12 h after surgery.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Eye Institute of Shandong First Medical University, Qingdao Eye Hospital of Shandong First Medical University.'}, {'ForeName': 'Zuojun', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Eye Institute of Shandong First Medical University, Qingdao Eye Hospital of Shandong First Medical University.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Eye Institute of Shandong First Medical University, Qingdao Eye Hospital of Shandong First Medical University.'}, {'ForeName': 'Yongheng', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Eye Institute of Shandong First Medical University, Qingdao Eye Hospital of Shandong First Medical University.'}]","Ear, nose, & throat journal",['10.1177/01455613221108366']
1765,35699869,Rivaroxaban After Transcatheter Aortic Valve Replacement: A Critical Appraisal of the GALILEO Trial.,"PURPOSE


The anti-thrombotic approach in individuals undergoing transcatheter aortic valve replacement (TAVR) mirrors a controversial field in clinical practice.
METHODS/RESULTS


The aim of this article was to critically appraise the randomized controlled GALILEO trial, where two different antithrombotic regimes (10 mg rivaroxaban + 3 months aspirin vs. aspirin + 3 months clopidogrel) were compared in patients who underwent TAVR as well as available evidence in literature in this field.
CONCLUSION


The GALILEO trial was prematurely terminated as a consequence of increased risk of both death or thromboembolic complications and a higher risk of bleeding in the anticoagulation arm, compared to the antiplatelet-based strategy. Various concerns have been raised that the negative results of the GALILEO trial need to be regarded with caution. A routine use of oral anticoagulation (OAC) for the prevention of atherothrombotic events and valve thrombosis after TAVR in individuals who do not have an indication for oral anticoagulation, can currently not be recommended when considering the evidence base of available literature. However, the negative results of the GALILEO trial need to be interpreted with caution - especially in terms of dose of rivaroxaban - and should not discourage from performing further trials investigating safety and efficacy of this therapeutic approach. Additionally, further dose-finding trials for rivaroxaban should be considered.",2022,"A routine use of oral anticoagulation (OAC) for the prevention of atherothrombotic events and valve thrombosis after TAVR in individuals who do not have an indication for oral anticoagulation, can currently not be recommended when considering the evidence base of available literature.","['patients who underwent TAVR as well as available evidence in literature in this field', 'individuals undergoing', 'atherothrombotic events and valve thrombosis after TAVR in individuals who do not have an indication for oral anticoagulation']","['transcatheter aortic valve replacement (TAVR', 'oral anticoagulation (OAC', 'Transcatheter Aortic Valve Replacement', 'rivaroxaban', 'Rivaroxaban', 'rivaroxaban + 3 months aspirin vs. aspirin + 3 months clopidogrel']",['risk of both death or thromboembolic complications and a higher risk of bleeding'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4039184', 'cui_str': 'High risk of bleeding'}]",,0.236479,"A routine use of oral anticoagulation (OAC) for the prevention of atherothrombotic events and valve thrombosis after TAVR in individuals who do not have an indication for oral anticoagulation, can currently not be recommended when considering the evidence base of available literature.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sulzgruber', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. patrick.sulzgruber@muv.ac.at.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hammer', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Niessner', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-022-07350-y']
1766,35699809,"ASO Visual Abstract: The Role of Adjuvant Use of the PlasmaJet ®  Device During Cytoreductive Surgery for Advanced-Stage Ovarian Cancer-Results of the PlaComOv-Study, a Randomized, Controlled Trial in the Netherlands.",,2022,,[],"['Cytoreductive Surgery', 'PlasmaJet ®  Device']",[],[],"[{'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",[],,0.326343,,"[{'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Nieuwenhuyzen-de Boer', 'Affiliation': 'Department of Gynecologic Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands. g.nieuwenhuyzen-deboer@erasmusmc.nl.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hofhuis', 'Affiliation': 'Department of Obstetrics and Gynecology, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Reesink-Peters', 'Affiliation': 'Department of Obstetrics and Gynecology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Willemsen', 'Affiliation': 'Department of Epidemiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Boere', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Schoots', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'J M J', 'Initials': 'JMJ', 'LastName': 'Piek', 'Affiliation': 'Department of Obstetrics and Gynecology, Catharina Cancer Institute, Eindhoven, The Netherlands.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Hofman', 'Affiliation': 'Department of Obstetrics and Gynecology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Beltman', 'Affiliation': 'Department of Obstetrics and Gynecology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'van Driel', 'Affiliation': 'Department of Gynecology, Center of Gynecological Oncology Amsterdam, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'H M J', 'Initials': 'HMJ', 'LastName': 'Werner', 'Affiliation': 'Department of Obstetrics and Gynecology, GROW, School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baalbergen', 'Affiliation': 'Department of Obstetrics and Gynecology, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'A M L D', 'Initials': 'AMLD', 'LastName': 'van Haaften-de Jong', 'Affiliation': 'Department of Obstetrics and Gynecology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dorman', 'Affiliation': 'Department of Obstetrics and Gynecology, Bravis Hospital, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Haans', 'Affiliation': 'Department of Obstetrics and Gynecology, Haags Medical Centre, The Hague, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Nedelcu', 'Affiliation': 'Department of Obstetrics and Gynecology, Groene Hart Hospital, Gouda, The Netherlands.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Ewing-Graham', 'Affiliation': 'Department of Pathology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'van Beekhuizen', 'Affiliation': 'Department of Gynecologic Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",Annals of surgical oncology,['10.1245/s10434-022-11820-w']
1767,35695334,Janus kinase inhibitors for the treatment of COVID-19.,"BACKGROUND


With potential antiviral and anti-inflammatory properties, Janus kinase (JAK) inhibitors represent a potential treatment for symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. They may modulate the exuberant immune response to SARS-CoV-2 infection. Furthermore, a direct antiviral effect has been described. An understanding of the current evidence regarding the efficacy and safety of JAK inhibitors as a treatment for coronavirus disease 2019 (COVID-19) is required.
OBJECTIVES


To assess the effects of systemic JAK inhibitors plus standard of care compared to standard of care alone (plus/minus placebo) on clinical outcomes in individuals (outpatient or in-hospital) with any severity of COVID-19, and to maintain the currency of the evidence using a living systematic review approach.
SEARCH METHODS


We searched the Cochrane COVID-19 Study Register (comprising MEDLINE, Embase, ClinicalTrials.gov, World Health Organization (WHO) International Clinical Trials Registry Platform, medRxiv, and Cochrane Central Register of Controlled Trials), Web of Science, WHO COVID-19 Global literature on coronavirus disease, and the US Department of Veterans Affairs Evidence Synthesis Program (VA ESP) Covid-19 Evidence Reviews to identify studies up to February 2022. We monitor newly published randomised controlled trials (RCTs) weekly using the Cochrane COVID-19 Study Register, and have incorporated all new trials from this source until the first week of April 2022.
SELECTION CRITERIA


We included RCTs that compared systemic JAK inhibitors plus standard of care to standard of care alone (plus/minus placebo) for the treatment of individuals with COVID-19. We used the WHO definitions of illness severity for COVID-19.
DATA COLLECTION AND ANALYSIS


We assessed risk of bias of primary outcomes using Cochrane's Risk of Bias 2 (RoB 2) tool. We used GRADE to rate the certainty of evidence for the following primary outcomes: all-cause mortality (up to day 28), all-cause mortality (up to day 60), improvement in clinical status: alive and without need for in-hospital medical care (up to day 28), worsening of clinical status: new need for invasive mechanical ventilation or death (up to day 28), adverse events (any grade), serious adverse events, secondary infections.
MAIN RESULTS


We included six RCTs with 11,145 participants investigating systemic JAK inhibitors plus standard of care compared to standard of care alone (plus/minus placebo). Standard of care followed local protocols and included the application of glucocorticoids (five studies reported their use in a range of 70% to 95% of their participants; one study restricted glucocorticoid use to non-COVID-19 specific indications), antibiotic agents, anticoagulants, and antiviral agents, as well as non-pharmaceutical procedures. At study entry, about 65% of participants required low-flow oxygen, about 23% required high-flow oxygen or non-invasive ventilation, about 8% did not need any respiratory support, and only about 4% were intubated. We also identified 13 ongoing studies, and 9 studies that are completed or terminated and where classification is pending. Individuals with moderate to severe disease Four studies investigated the single agent baricitinib (10,815 participants), one tofacitinib (289 participants), and one ruxolitinib (41 participants). Systemic JAK inhibitors probably decrease all-cause mortality at up to day 28 (95 of 1000 participants in the intervention group versus 131 of 1000 participants in the control group; risk ratio (RR) 0.72, 95% confidence interval (CI) 0.57 to 0.91; 6 studies, 11,145 participants; moderate-certainty evidence), and decrease all-cause mortality at up to day 60 (125 of 1000 participants in the intervention group versus 181 of 1000 participants in the control group; RR 0.69, 95% CI 0.56 to 0.86; 2 studies, 1626 participants; high-certainty evidence). Systemic JAK inhibitors probably make little or no difference in improvement in clinical status (discharged alive or hospitalised, but no longer requiring ongoing medical care) (801 of 1000 participants in the intervention group versus 778 of 1000 participants in the control group; RR 1.03, 95% CI 1.00 to 1.06; 4 studies, 10,802 participants; moderate-certainty evidence). They probably decrease the risk of worsening of clinical status (new need for invasive mechanical ventilation or death at day 28) (154 of 1000 participants in the intervention group versus 172 of 1000 participants in the control group; RR 0.90, 95% CI 0.82 to 0.98; 2 studies, 9417 participants; moderate-certainty evidence). Systemic JAK inhibitors probably make little or no difference in the rate of adverse events (any grade) (427 of 1000 participants in the intervention group versus 441 of 1000 participants in the control group; RR 0.97, 95% CI 0.88 to 1.08; 3 studies, 1885 participants; moderate-certainty evidence), and probably decrease the occurrence of serious adverse events (160 of 1000 participants in the intervention group versus 202 of 1000 participants in the control group; RR 0.79, 95% CI 0.68 to 0.92; 4 studies, 2901 participants; moderate-certainty evidence). JAK inhibitors may make little or no difference to the rate of secondary infection (111 of 1000 participants in the intervention group versus 113 of 1000 participants in the control group; RR 0.98, 95% CI 0.89 to 1.09; 4 studies, 10,041 participants; low-certainty evidence). Subgroup analysis by severity of COVID-19 disease or type of JAK inhibitor did not identify specific subgroups which benefit more or less from systemic JAK inhibitors. Individuals with asymptomatic or mild disease We did not identify any trial for this population.
AUTHORS' CONCLUSIONS


In hospitalised individuals with moderate to severe COVID-19, moderate-certainty evidence shows that systemic JAK inhibitors probably decrease all-cause mortality. Baricitinib was the most often evaluated JAK inhibitor. Moderate-certainty evidence suggests that they probably make little or no difference in improvement in clinical status. Moderate-certainty evidence indicates that systemic JAK inhibitors probably decrease the risk of worsening of clinical status and make little or no difference in the rate of adverse events of any grade, whilst they probably decrease the occurrence of serious adverse events. Based on low-certainty evidence, JAK inhibitors may make little or no difference in the rate of secondary infection. Subgroup analysis by severity of COVID-19 or type of agent failed to identify specific subgroups which benefit more or less from systemic JAK inhibitors. Currently, there is no evidence on the efficacy and safety of systemic JAK inhibitors for individuals with asymptomatic or mild disease (non-hospitalised individuals).",2022,"Systemic JAK inhibitors probably decrease all-cause mortality at up to day 28 (95 of 1000 participants in the intervention group versus 131 of 1000 participants in the control group; risk ratio (RR) 0.72, 95% confidence interval (CI) 0.57 to 0.91; 6 studies, 11,145 participants; moderate-certainty evidence), and decrease all-cause mortality at up to day 60 (125 of 1000 participants in the intervention group versus 181 of 1000 participants in the control group; RR 0.69, 95% CI 0.56 to 0.86; 2 studies, 1626 participants; high-certainty evidence).","['individuals (outpatient or in-hospital) with any severity of COVID-19, and to maintain the currency of the evidence using a living systematic review approach', 'individuals with COVID-19', 'Individuals with moderate to severe disease Four studies investigated the single agent baricitinib (10,815 participants), one tofacitinib (289 participants), and one ruxolitinib (41 participants', 'individuals with asymptomatic or mild disease (non-hospitalised individuals', 'Individuals with asymptomatic or mild disease', '11,145 participants investigating']","['JAK inhibitors', 'systemic JAK inhibitors', 'systemic JAK inhibitors plus standard of care to standard of care alone (plus/minus placebo', 'systemic JAK inhibitors plus standard of care compared to standard of care alone (plus/minus placebo']","['clinical status: alive and without need for in-hospital medical care', 'rate of adverse events', 'occurrence of serious adverse events', 'rate of secondary infection', 'adverse events (any grade), serious adverse events, secondary infections', 'worsening of clinical status: new need for invasive mechanical ventilation or death', 'risk of worsening of clinical status', 'cause mortality', 'high-flow oxygen or non-invasive ventilation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1955832', 'cui_str': 'Review, Systematic'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C3854325', 'cui_str': 'Janus kinase inhibitor'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0442886', 'cui_str': 'Secondary infection'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]",11145.0,0.58788,"Systemic JAK inhibitors probably decrease all-cause mortality at up to day 28 (95 of 1000 participants in the intervention group versus 131 of 1000 participants in the control group; risk ratio (RR) 0.72, 95% confidence interval (CI) 0.57 to 0.91; 6 studies, 11,145 participants; moderate-certainty evidence), and decrease all-cause mortality at up to day 60 (125 of 1000 participants in the intervention group versus 181 of 1000 participants in the control group; RR 0.69, 95% CI 0.56 to 0.86; 2 studies, 1626 participants; high-certainty evidence).","[{'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Kramer', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Prinz', 'Affiliation': 'Department of Anesthesiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Fichtner', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Fischer', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Thieme', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Grundeis', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Spagl', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seeber', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Piechotta', 'Affiliation': 'Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Maria-Inti', 'Initials': 'MI', 'LastName': 'Metzendorf', 'Affiliation': 'Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Golinski', 'Affiliation': 'Department of Anesthesiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany.'}, {'ForeName': 'Onnen', 'Initials': 'O', 'LastName': 'Moerer', 'Affiliation': 'Department of Anesthesiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany.'}, {'ForeName': 'Caspar', 'Initials': 'C', 'LastName': 'Stephani', 'Affiliation': 'Department of Anesthesiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Mikolajewska', 'Affiliation': 'Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': 'Department of Intensive Care Medicine, Medical Center Hamburg Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Stegemann', 'Affiliation': 'Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Laudi', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Skoetz', 'Affiliation': 'Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD015209']
1768,35695332,No rebound effect after a course of clopidogrel in patients with acute TIA or minor stroke.,"BACKGROUND AND PURPOSE


Previous studies demonstrated that discontinuation of clopidogrel in patients after ACS was associated with a rebound increase in risk of recurrent events. In this study, we aimed to investigate the rebound effect after discontinuation of clopidogrel therapy in patients with TIA or stroke.
METHODS


All patients with minor stroke or TIA were recruited from the Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events (CHANCE) trial. Patients were divided into two groups: patients who discontinued clopidogrel and switched to aspirin therapy   (Clopidogrel Discontinuation Group) and patients who continued one mono-antiplatelet therapy (non-Clopidogrel Discontinuation Group) during 90-180  days. The outcomes included risks of recurrent ischemic stroke, recurrent TIA, and composite events during 90-180  days. The prevalence of each outcome was compared between two groups for every 30 days. Further subgroup analysis was conducted in patients with and without CYP2C19 loss-of-function alleles.
RESULTS


Among the 3456 patients included, a total of 10 patients in the Clopidogrel Discontinuation Group and 11 patients in the non-Clopidogrel Discontinuation Group presented ischemic stroke recurrence during the 90-180-day period. The inter-group comparisons were not significant in each 30 days. Similar results were found for recurrent stroke, recurrent TIA, and composite events in these two groups, which were also found in CYP2C19 subgroup analysis.
CONCLUSIONS


No rebound increase in the risk of ischemic stroke and composite events was found during the 90 days after discontinuation of clopidogrel therapy in patients with TIA or minor stroke in the CHANCE trial.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00979589.",2022,"No rebound increase in the risk of ischemic stroke and composite events was found during the 90 days after discontinuation of clopidogrel therapy in patients with TIA or minor stroke in the CHANCE trial.
","['patients with TIA or stroke', 'patients with acute TIA or minor stroke', 'All patients with minor stroke or TIA', 'patients with and without CYP2C19 loss-of-function alleles', '3456 patients included, a total of 10 patients in the Clopidogrel Discontinuation Group and 11 patients in the non']","['clopidogrel therapy', 'clopidogrel', 'discontinued clopidogrel', 'aspirin therapy \xa0\xa0(Clopidogrel Discontinuation Group) and patients who continued one mono-antiplatelet therapy (non-Clopidogrel Discontinuation Group', 'Clopidogrel Discontinuation', 'Clopidogrel']","['recurrent stroke, recurrent TIA, and composite events', 'ischemic stroke recurrence', 'risk of recurrent events', 'risks of recurrent ischemic stroke, recurrent TIA, and composite events', 'risk of ischemic stroke and composite events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C2363728', 'cui_str': 'Recurrent TIA'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",3456.0,0.0524236,"No rebound increase in the risk of ischemic stroke and composite events was found during the 90 days after discontinuation of clopidogrel therapy in patients with TIA or minor stroke in the CHANCE trial.
","[{'ForeName': 'Xinmiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Anxin', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing, China.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Neurovascular Division, Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Az, USA.""}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': 'Dell Medical School, University of Texas at Austin, Texas, USA.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital Capital Medical University, Beijing, China.'}]",Neurological research,['10.1080/01616412.2022.2075660']
1769,35695169,"JNJ-73763989 pharmacokinetics and safety: Liver-targeted siRNAs against hepatitis B virus, in Japanese and non-Japanese healthy adults, and combined with JNJ-56136379 and a nucleos(t)ide analogue in patients with chronic hepatitis B.","BACKGROUND


JNJ-73763989 comprises two hepatitis B virus (HBV)-specific, liver-targeted N-galactosamine-conjugated short interfering RNA triggers, JNJ-73763976 and JNJ-73763924. JNJ-73763989 pharmacokinetics, safety and tolerability were assessed in two phase 1 studies: Japanese (NCT04002752), and non-Japanese healthy participants and chronic hepatitis B (CHB) patients also receiving the HBV capsid assembly modulator JNJ-56136379 and a nucleos(t)ide analogue (NA) (NCT03365947).
METHODS


Healthy participant cohorts were double-blind and randomized to receive a single subcutaneous JNJ-73763989 dose (non-Japanese participants, 35, 100, 200, 300 or 400 mg; Japanese participants, 25, 100 or 200 mg) or placebo. JNJ-73763976 and JNJ-73763924 plasma concentrations were assessed over 48 h. CHB patients received JNJ-73763989 200 mg every 4 weeks plus daily oral JNJ-56136379 250 mg and NA in an open-label fashion. Safety and tolerability were assessed through Day 28 (healthy participants) or Day 112 (patients).
RESULTS


Thirty non-Japanese ( n  = 4/dose; placebo,  n  = 10) and 24 Japanese healthy participants ( n  = 6/dose; placebo,  n  = 6) were randomized. JNJ-73763976 and JNJ-73763924 exposure generally increased in a dose-proportional manner. Mean plasma half-life was 4-9 h. No differences between pharmacokinetic parameters were apparent between non-Japanese and Japanese healthy participants. In the 12 CHB patients, mean JNJ-73763976, JNJ-73763924 and JNJ-56136379 plasma concentrations 2 h post-dose on Day 29 were 663, 269 and 14,718 ng/mL, respectively. In both studies, all adverse events were mild/moderate.
CONCLUSION


JNJ-73763976 and JNJ-73763924 had short plasma half-lives and exposure generally increased in a dose-proportional manner; there were no pharmacokinetic differences between Japanese and non-Japanese healthy adults. JNJ-73763989 with or without JNJ-56136379 and NA was generally safe and well tolerated.",2022,JNJ-73763976 and JNJ-73763924 exposure generally increased in a dose-proportional manner.,"['Day 28 (healthy participants) or Day 112 (patients', 'Japanese and non-Japanese healthy adults', 'patients with chronic hepatitis B', 'Healthy participant cohorts', 'Japanese healthy participants and chronic hepatitis B (CHB) patients also receiving the HBV capsid assembly modulator JNJ-56136379 and a nucleos(t)ide analogue (NA) (NCT03365947', 'Thirty non-Japanese ( n  = 4/dose; placebo,  n  = 10) and 24 Japanese healthy participants ( n  = 6/dose; placebo,  n  = 6']",['placebo'],"['JNJ-73763976 and JNJ-73763924 plasma concentrations', 'JNJ-73763989 pharmacokinetics, safety and tolerability', 'Safety and tolerability', 'safe and well tolerated', 'Mean plasma half-life']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0006933', 'cui_str': 'Capsid'}, {'cui': 'C1670794', 'cui_str': ""N6-(N'-phenylcarbamoyl)-2'-deoxyadenosine""}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",6.0,0.103034,JNJ-73763976 and JNJ-73763924 exposure generally increased in a dose-proportional manner.,"[{'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'New Zealand Liver Transplant Unit, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine, 25809The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Kakuda', 'Affiliation': '333755Janssen BioPharma Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': '38200Janssen Pharmaceutical KK, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': '38200Janssen Pharmaceutical KK, Tokyo, Japan.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Goeyvaerts', 'Affiliation': '50148Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lonjon-Domanec', 'Affiliation': 'Janssen-Cilag, Issy-les-Moulineaux, France.'}, {'ForeName': 'Tamisha', 'Initials': 'T', 'LastName': 'Vaughan', 'Affiliation': '17519Arrowhead Pharmaceuticals, Pasadena, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schluep', 'Affiliation': '17519Arrowhead Pharmaceuticals, Pasadena, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': '17519Arrowhead Pharmaceuticals, Pasadena, CA, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Njumbe Ediage', 'Affiliation': '50148Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Hillewaert', 'Affiliation': '50148Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Snoeys', 'Affiliation': '50148Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Lenz', 'Affiliation': '50148Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Talloen', 'Affiliation': '50148Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Biermer', 'Affiliation': '50148Janssen Pharmaceutica NV, Beerse, Belgium.'}]",Antiviral therapy,['10.1177/13596535221093856']
1770,35695582,"Is mirtazapine augmentation effective for patients with obsessive-compulsive disorder who failed to respond to sertraline monotherapy? A placebo-controlled, double-blind, clinical trial.","Mirtazapine upsurges serotonergic activity by a mechanism different from reuptake inhibition. Our aim is to assess the efficacy of mirtazapine augmentation for patients with obsessive-compulsive disorder (OCD) who did not respond to sertraline monotherapy. Sixty-one patients suffering from OCD who were resistant to sertraline monotherapy were randomly allocated to receive mirtazapine (mean dosage = 39.56 mg/day) or placebo plus their current anti-OCD treatment (sertraline: average dose = 251.37 mg/day and 255.10 mg/day in the mirtazapine and placebo groups, respectively; P = 0.871). The primary outcome was OCD symptom severity as measured by Yale-Brown Obsessive-Compulsive Scale (YBOCS). Forty-five patients (22 in the mirtazapine group and 23 in the placebo group) completed the trial. Average YBOCS score decreased in the mirtazapine group from 27.14 ± 8.05 at baseline to 11.13 ± 4.27 at week 12. In the placebo group, average YBOCS score declined from 28.15 ± 3.27 at baseline to 18.94 ± 3.88 at week 12. Nine patients (40.90%) in the mirtazapine group and only one patient (4.34%) in the placebo group revealed at least a 35% decrease in YBOCS (P < 0.000). We found that mirtazapine adds to the effect of sertraline in improving obsessive and compulsive symptoms in OCD patients.",2022,Average YBOCS score decreased in the mirtazapine group from 27.14 ± 8.05 at baseline to 11.13 ± 4.27 at week 12.,"['patients with obsessive-compulsive disorder (OCD) who did not respond to sertraline monotherapy', 'OCD patients', 'Forty-five patients (22 in the mirtazapine group and 23 in the placebo group) completed the trial', 'Sixty-one patients suffering from OCD who were resistant to sertraline monotherapy', 'patients with obsessive-compulsive disorder']","['placebo plus their current anti-OCD treatment (sertraline', 'mirtazapine', 'sertraline', 'Mirtazapine', 'mirtazapine augmentation', 'mirtazapine and placebo', 'placebo']","['YBOCS', 'OCD symptom severity as measured by Yale-Brown Obsessive-Compulsive Scale (YBOCS', 'obsessive and compulsive symptoms', 'Average YBOCS score', 'average YBOCS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.241258,Average YBOCS score decreased in the mirtazapine group from 27.14 ± 8.05 at baseline to 11.13 ± 4.27 at week 12.,"[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mowla', 'Affiliation': 'Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences.'}, {'ForeName': 'Haniyeh', 'Initials': 'H', 'LastName': 'Baniasadipour', 'Affiliation': 'Substance Abuse and Mental Health Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000415']
1771,35695576,Consideration of the adaptive randomization allocation ratio in the presence of treatment group heteroscedasticity in clinical trials.,"For randomized clinical trials, subjects' variance structures may vary over time among treatment groups, resulting in the heteroscedasticity of residuals in a regression analysis. Commonly used methods that assume equal variance among all treatment groups may not be able to control for a type I error. When the variances are indeed the same across treatment groups, an equal randomization allocation ratio will yield the greatest study power. However, out of ethical concern or urgent need for rare disease clinical trials, more patients may have to be allocated to the study drug arm. In these situations, an unequal randomization ratio should be considered. We propose a group variance-covariance and structures-based method to adapt the randomization ratio after interim analysis. We use simulations to compare commonly used statistical methods for continuous endpoints in assessing the impact of heteroscedasticity in equal and unequal randomization ratios and examine the extent to which the findings are affected by missing data.",2022,"When the variances are indeed the same across treatment groups, an equal randomization allocation ratio will yield the greatest study power.",[],[],[],[],[],[],,0.108137,"When the variances are indeed the same across treatment groups, an equal randomization allocation ratio will yield the greatest study power.","[{'ForeName': 'Jiashen', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Statistics, University of Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Yeh-Fong', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Division of Biometrics IX, Office of Biostatistics, US Food and Drug Administration Center for Drug Evaluation and Research, Maryland, United States.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2022.2080697']
1772,35695389,Effectiveness of Hoffman's Exercise in Postnatal Mothers With Grade 1 Inverted Nipples.,"BACKGROUND


Breastfeeding provides perfect nutrition for infants. The inverted nipples in mothers make breastfeeding more challenging. Besides surgical approaches, non-pharmacological interventions are also gaining importance.
RESEARCH AIM


To evaluate the effectiveness of Hoffman's exercise on breastfeeding among postnatal mothers with grade I inverted nipples.
METHOD


A quantitative approach with a parallel arm randomized controlled trial was used in the study. Postnatal mothers were screened for inverted nipples using a pinch test. Participants with at least one inverted nipple (Grade 1) were randomly allocated into two groups: the experimental group (supported with Hoffman's exercise;  n  = 28, 50.9% ) and the control group (without Hoffman's exercise;  n  = 27, 49.1%). The pre-test data, including demographics, nipple length, and breastfeeding assessment, were collected. Breastfeeding assessment was evaluated using the Bristol Breastfeeding Assessment Tool (BBAT). On the 3rd day, the post-test data, including nipple length and Breastfeeding Assessment, were collected among the groups.
RESULTS


The BBAT assessment was significantly higher in the post-test compared to that of the pre-test in the participants provided with Hoffman's exercise. The nipple length was found to be higher in participants provided with Hoffman's exercise. Furthermore, the variables-including age, gravida, nipple problems, and delivery type-were not found to have any significant effect with either pre-test or post-test levels of breastfeeding.
CONCLUSIONS


Hoffman's exercise was found to be an effective method to improve breastfeeding in Grade 1 nipple-inverted among post-natal mothers. This nipple exercise is inexpensive, easy to follow, and results in the successful initiation of breastfeeding.
CLINICAL TRIAL REGISTRY AND REGISTRATION NUMBER


CTRI/2019/05/019279, May 23, 2019 (retrospectively registered).",2022,The BBAT assessment was significantly higher in the post-test compared to that of the pre-test in the participants provided with Hoffman's exercise.,"['infants', 'Postnatal Mothers With Grade 1 Inverted Nipples', 'Postnatal mothers', 'postnatal mothers with grade I inverted nipples', 'Participants with at least one inverted nipple (Grade 1']","[""Hoffman's exercise"", ""Hoffman's Exercise"", ""control group (without Hoffman's exercise""]","['nipple length', 'Bristol Breastfeeding Assessment Tool (BBAT', 'nipple length and Breastfeeding Assessment', 'BBAT assessment', 'demographics, nipple length, and breastfeeding assessment']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0269269', 'cui_str': 'Inversion of nipple'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C4040399', 'cui_str': 'Assessment of breastfeeding'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.0158132,The BBAT assessment was significantly higher in the post-test compared to that of the pre-test in the participants provided with Hoffman's exercise.,"[{'ForeName': 'Anju Philip', 'Initials': 'AP', 'LastName': 'Thurkkada', 'Affiliation': 'Amrita College of Nursing, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Salini', 'Initials': 'S', 'LastName': 'Rajasekharan Nair', 'Affiliation': 'Amrita College of Nursing, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Amrita College of Nursing, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Parvathy', 'Initials': 'P', 'LastName': 'Sreelekha', 'Affiliation': 'Amrita College of Nursing, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Soumya Kadakkuzha', 'Initials': 'SK', 'LastName': 'Sanu', 'Affiliation': 'Amrita College of Nursing, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Parvathy R', 'Initials': 'PR', 'LastName': 'Chandran', 'Affiliation': 'CSIR- National Institute for Interdisciplinary Science and Technology, Thiruvananthapuram, India.'}, {'ForeName': 'Gopinathan', 'Initials': 'G', 'LastName': 'Pillai Sreekanth', 'Affiliation': 'Siriraj Center of Research Excellence for Molecular Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of human lactation : official journal of International Lactation Consultant Association,['10.1177/08903344221102890']
1773,35695863,FOXM1 variant contributes to gefitinib resistance via activating wnt/β-catenin signal pathway in non-small cell lung cancer patients.,"PURPOSE


Although gefitinib prolonged the progression-free survival (PFS) of non-small cell lung cancer (NSCLC) patients, unpredictable resistance limited its clinical efficacy. Novel predictive biomarkers with explicit mechanisms are urgently needed.
EXPERIMENTAL DESIGN


A total of 282 NSCLC patients with gefitinib treatment were randomly assigned in a 7:3 ratio to exploratory (n=192) and validation (n=90) cohorts. The candidate polymorphisms were selected with Haploview4.2 in Hapmap and genotyped by a MassARRAY system, and the feature variables were identified through Randomforest Survival analysis. Tans-well and clonogenic assays, base editing and cell-derived tumor xenograft model were performed to uncover the underlying mechanism.
RESULTS


We found that the germline missense polymorphism rs3742076 (A>G, S628P), located in transactivation domain of FOXM1, was associated with PFS in exploratory (median PFS: GG vs. GA&AA, 9.20 vs. 13.37 months, P=0.00039, HR=2.399) and validation (median PFS: GG vs. GA&AA, 8.13 vs. 13.80 months, P=0.048, HR=2.628) cohorts. We elucidated that rs3742076_G conferred resistance to gefitinib by increasing protein stability of FOXM1 and facilitating an aggressive phenotype in vitro and in vivo through activating wnt/β-catenin signaling pathway. Meanwhile, FOXM1 level was highly associated with prognosis in EGFR-mutant NSCLC patients. Mechanistically, FOXM1 rs3742076_G upregulated wnt/β-catenin activity by directly binding to β-catenin in cytoplasm and promoting transcription of β-catenin in nucleus. Remarkably, inhibition of β-catenin markedly reversed rs3742076_G-induced gefitinib resistance and aggressive phenotypes.
CONCLUSION


These findings characterized rs3742076_G as a gain-of-function polymorphism in mediating gefitinib resistance and tumor aggressiveness, and highlighted the variant as a predictive biomarker in guiding gefitinib treatment.",2022,"Mechanistically, FOXM1 rs3742076_G upregulated wnt/β-catenin activity by directly binding to β-catenin in cytoplasm and promoting transcription of β-catenin in nucleus.","['non-small cell lung cancer patients', '282 NSCLC patients with gefitinib treatment']",[],"['inhibition of β-catenin markedly reversed rs3742076_G-induced gefitinib resistance and aggressive phenotypes', 'progression-free survival (PFS']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",282.0,0.185864,"Mechanistically, FOXM1 rs3742076_G upregulated wnt/β-catenin activity by directly binding to β-catenin in cytoplasm and promoting transcription of β-catenin in nucleus.","[{'ForeName': 'Shaoxing', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Sun Yat-sen University, guanhzhou, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Youhao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University, Guangzhou, guangdong, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Sun Yat sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou, guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'Sun Yat-sen University, Guangzhou, guangdong, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xueding', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Sun Yat-sen University, Guangzhou, guangdong, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-22-0791']
1774,35695687,Traditional Vietnamese medicine Kovir capsule in patients with mild COVID-19: A double-blind randomized controlled trial.,"Kovir capsule, a polyherbal medicine developed from Ren Shen Bai Du San formulation, has been used in various diseases including respiratory infections. A randomized, placebo-controlled, double-blind study was conducted to evaluate the safety and efficacy of Kovir capsule (TD0069) in the treatment of mild COVID-19 patients. Patients aged from 18 to 65 years who were PCR-confirmed with SARS-CoV-2 and had the mild disease were recruited and randomized to either Kovir capsule (34 patients) or placebo (32 patients) for up to 14 days or until discharge. Efficacy outcomes were time to viral clearance, daily viral load, time to symptom resolution, daily symptom score based on 16 pre-defined symptoms, and progression to severe/critical COVID-19. Safety outcomes were adverse events. Viral load decreased over time similarly in the two groups. Viral clearance time was also similar in both groups (median: 8 days). Kovir group had a more rapid decrease of symptom score and significantly lower time to symptom resolution than placebo (median: 4 vs. 7 days). Two patients in the placebo group developed severe COVID-19. No patient experienced adverse events. Kovir capsule is safe and can improve symptom resolution in mild COVID-19 patients. A large-scale trial is required to confirm these findings.",2022,Kovir group had a more rapid decrease of symptom score and significantly lower time to symptom resolution than placebo (median: 4 vs. 7 days).,"['mild COVID-19 patients', 'Patients aged from 18 to 65\u2009years who were PCR-confirmed with SARS-CoV-2 and had the mild disease', 'patients with mild COVID-19']","['Kovir capsule (TD0069', 'Traditional Vietnamese medicine Kovir capsule', 'placebo', 'Kovir capsule']","['adverse events', 'symptom score', 'Viral load', 'Viral clearance time', 'symptom resolution', 'time to symptom resolution', 'severe COVID-19', 'safety and efficacy', 'time to viral clearance, daily viral load, time to symptom resolution, daily symptom score based on 16 pre-defined symptoms, and progression to severe/critical COVID-19']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.605951,Kovir group had a more rapid decrease of symptom score and significantly lower time to symptom resolution than placebo (median: 4 vs. 7 days).,"[{'ForeName': 'Huynh Nguyen', 'Initials': 'HN', 'LastName': 'Loc', 'Affiliation': 'Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Truong Thi Ngoc', 'Initials': 'TTN', 'LastName': 'Lan', 'Affiliation': 'Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dinh Thi Lan', 'Initials': 'DTL', 'LastName': 'Huong', 'Affiliation': 'Department of Training, Scientific Researching, Health Activities Direction, Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Tuyen', 'Affiliation': 'Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran Minh', 'Initials': 'TM', 'LastName': 'Quang', 'Affiliation': 'General Medicine Department, Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ly Minh', 'Initials': 'LM', 'LastName': 'Dao', 'Affiliation': 'Department of Training, Scientific Researching, Health Activities Direction, Traditional Medicine Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Pham Hung', 'Initials': 'PH', 'LastName': 'Van', 'Affiliation': 'International Institute of Gene and Immunology (IGI), Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Lam', 'Initials': 'NL', 'LastName': 'Vuong', 'Affiliation': 'Department of Medical Statistics and Informatics, Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}]",Phytotherapy research : PTR,['10.1002/ptr.7455']
1775,35695680,One size does not fit all for parent-mediated autism interventions: A randomized clinical trial.,"LAY ABSTRACT


Parent-mediated interventions support parents' use of language facilitation strategies to improve their autistic child's communication and language development. To improve the effectiveness of parent-mediated interventions, it is important to individualize interventions. This article evaluates how different components of parent-mediated interventions and mothers' learning styles influence the effectiveness of the intervention. In a randomized clinical trial, mothers were taught to use one of two types of language facilitation strategies: responsive and directive. Mothers' learning styles were characterized by the Broad Autism Phenotype (BAP) and their natural tendency to use language facilitation strategies before intervention. Findings suggest that it was easier for all mothers (irrespective of learning style) to use responsive strategies compared to directive strategies. In addition, mothers with learning styles that were not consistent with the BAP were more likely to benefit from the intervention if they did not naturally use strategies before the intervention. In contrast, mothers with learning styles that were consistent with the BAP were more likely to benefit from the intervention if they did naturally use strategies before the intervention. Teaching mothers to use responsive strategies results in greater strategy use. Consideration of BAP and mothers' natural use of language facilitation strategies may inform intervention individualization.",2022,Findings suggest that it was easier for all mothers (irrespective of learning style) to use responsive strategies compared to directive strategies.,['mothers with learning styles'],[],[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],[],,0.0145221,Findings suggest that it was easier for all mothers (irrespective of learning style) to use responsive strategies compared to directive strategies.,"[{'ForeName': 'Megan Y', 'Initials': 'MY', 'LastName': 'Roberts', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Bailey J', 'Initials': 'BJ', 'LastName': 'Sone', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Maranda', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Grauzer', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sudec', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Yael S', 'Initials': 'YS', 'LastName': 'Stern', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Kwok', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Losh', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Kaat', 'Affiliation': 'Northwestern University, USA.'}]",Autism : the international journal of research and practice,['10.1177/13623613221102736']
1776,35695671,What Role Does a Colored Under Glove Have in Detecting Glove Perforation in Foot and Ankle Procedures?,"BACKGROUND


Many orthopaedic surgical teams practice double gloving or use colored indicator gloving techniques to reduce contamination intraoperatively. Although the likelihood of glove perforation can be affected by the procedure type and surgeon habits, as well as the surgeon's technique, these factors have not been considered in order to determine the glove perforation rate, and the role of colored under gloving during operations seems less investigated.
QUESTIONS/PURPOSES


(1) What proportion of foot and ankle procedures result in perforation of outer gloves or under gloves? (2) What factors (such as the type or duration of operation) appear to be associated with the likelihood of glove perforation? (3) Does the use of a colored indicator under glove make it more likely that a surgeon would perceive the perforation of an outer glove intraoperatively?
METHODS


Between September 2020 and August 2021, I performed 577 surgical foot or ankle procedures. Of those, I considered patients who underwent subsequent operations under general or spinal anesthesia as potentially eligible. Further, 16% (93) were excluded because the procedures were performed with the patient under local anesthesia, and another 1% (eight patients) were not analyzed (incomplete datasets for emergency operations performed at night). Finally, 82% (476 patients) were examined. To ensure statistical independence, gloves used in right-side operation in bilateral procedures and the most proximal surgery in unilateral procedures were included. Preoperatively, the surgeon was randomly assigned to use either a combination of two regular surgical gloves or a regular outer glove worn over a colored indicator under glove. Patient diagnosis, type of procedure, tourniquet time, and gloving type were recorded. There was no difference in potentially relevant confounding variables, such as the proportion of procedures performed on bone (78% [188 of 242] versus 83% [195 of 234]; p = 0.13), nor in tourniquet time (58 ± 30 minutes versus 62 ± 31 minutes; p = 0.45) between the regular glove and indicator glove groups. At the end of each procedure, the surgeon was asked whether he believed either the outer or under glove was perforated, and whether the use of a colored under glove increased the proportion of procedures in which the surgeon correctly ascertained that a perforation had occurred. To determine the proportion of gloves that were perforated, a standardized water-leak method was used, and the proportion of gloves with perforations based on several parameters of interest, including bone versus soft tissue operation and tourniquet time, was compared.
RESULTS


During 476 foot and ankle procedures, the overall glove perforation proportion was 19% (92 of 476 procedures). Under-glove perforation was observed in 4% (17 of 476 procedures) of the operations. There was no difference in glove perforation proportions between bone and soft tissue operations (76 of 383 versus 16 of 93; odds ratio [OR] = 0.84, 95% confidence interval [CI], 0.46-1.52; p = 0.56). As tourniquet time (operation time) increased, the glove perforation proportion also increased (Exp[B] = 1.02; 95% CI, 1.01-1.03; p < 0.001). The use of indicator under gloves increased the surgeon's intraoperative detection of glove perforation (in 68% of procedures [32 of 47 versus 29% [13 of 45]; OR = 5.3; 95% CI, 2.2-12.8; p < 0.001).
CONCLUSION


Surgical glove perforation occurred in approximately one of five foot and ankle procedures. Based on the results of this study, I recommend using colored indicator under gloves and replacing the under glove when replacing the outer glove after perforation is seen, in order to detect contamination early and reduce any intraoperative contamination related to glove injury.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2022,"There was no difference in glove perforation proportions between bone and soft tissue operations (76 of 383 versus 16 of 93; odds ratio [OR] = 0.84, 95% confidence interval [CI], 0.46-1.52; p = 0.56).","['Between September 2020 and August 2021', 'patients who underwent subsequent operations under general or spinal anesthesia as potentially eligible']",[],"['overall glove perforation proportion', 'tourniquet time', 'proportion of procedures performed on bone', 'Surgical glove perforation', 'glove perforation proportion', ""surgeon's intraoperative detection of glove perforation"", 'glove perforation proportions between bone and soft tissue operations', 'Under-glove perforation', 'tourniquet time (operation time', 'Patient diagnosis, type of procedure, tourniquet time, and gloving type']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0017682', 'cui_str': 'Surgical glove'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0455713', 'cui_str': 'Procedure type'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",,0.0268263,"There was no difference in glove perforation proportions between bone and soft tissue operations (76 of 383 versus 16 of 93; odds ratio [OR] = 0.84, 95% confidence interval [CI], 0.46-1.52; p = 0.56).","[{'ForeName': 'Seung Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Myongji Hospital, Hanyang University College of Medicine, Gyeonggi, Korea.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000002268']
1777,35696054,Bioavailability Study of a Transdermal Patch Formulation of Rivastigmine Compared with Exelon in Healthy Subjects.,"BACKGROUND AND OBJECTIVES


Rivastigmine is a reversible cholinesterase inhibitor indicated for the treatment of all stages of Alzheimer's disease (AD). Transdermal patch formulation allows smooth and continuous drug delivery. Its tolerability, efficacy and convenience of use increase treatment compliance. This study was designed to evaluate the bioavailability and to assess the bioequivalence of two rivastigmine transdermal patches at steady state (RIV-TDS Test Product versus Exelon Marketed Reference Product), with a release rate of 13.3 mg/24 h, after multiple patch applications. As secondary objectives, safety, patch adhesion and skin irritation were evaluated.
METHODS


This was an open-label, randomized, balanced, two-period, two-sequence, cross-over study of healthy adults (n = 31). The treatment period consisted of two 5-day study periods during which consecutive daily application of the investigational patches with a release rate of 13.3 mg/24 h rivastigmine took place. Serial blood samples were collected to measure plasma concentrations. Adhesion and skin irritation assessments were performed after application of patches.
RESULTS


Point estimates and 90% confidence intervals of pharmacokinetic parameters at steady state, viz. area under the plasma concentration versus time curve from dosing time to the end of the dosing interval τ (profile day) at steady state [AUC 0-τ,ss ] (97.4; 88.8-106.9), maximum plasma concentration within the dosing interval τ (profile day) at steady state [C max,ss ] (99.6; 90.4-109.7) and trough plasma concentration at the end of the dosing interval τ (profile day) at steady state [C τ,ss ] (96.8; 86.2-108.9), demonstrated that both patches were bioequivalent. Evaluation of patch adhesion showed better skin adherence for RIV-TDS as well as dermal response scores (skin tolerability after removal).
CONCLUSIONS


For both products, bioequivalence was shown and systemic tolerability was in accordance with the safety profile of the drug substance. The trial is registered in ClinicalTrials.gov: NCT03573050 and EudraCT: 2018-000968-28.",2022,"Evaluation of patch adhesion showed better skin adherence for RIV-TDS as well as dermal response scores (skin tolerability after removal).
","['Healthy Subjects', 'healthy adults (n\xa0=\xa031']","['rivastigmine transdermal patches at steady state (RIV-TDS Test Product versus Exelon Marketed Reference Product', 'Rivastigmine']","['safety, patch adhesion and skin irritation', 'Adhesion and skin irritation assessments', 'dermal response scores (skin tolerability', 'skin adherence', 'trough plasma concentration', 'maximum plasma concentration', 'bioavailability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0172161', 'cui_str': 'tyramine-deoxysorbitol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0730987', 'cui_str': 'Exelon'}, {'cui': 'C1318228', 'cui_str': 'Market'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0402653,"Evaluation of patch adhesion showed better skin adherence for RIV-TDS as well as dermal response scores (skin tolerability after removal).
","[{'ForeName': 'Adelaida', 'Initials': 'A', 'LastName': 'Morte', 'Affiliation': 'ESTEVE Pharmaceuticals SA, Torre Esteve, Passeig de la Zona Franca, 109, 4ª Planta, 08038, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vaqué', 'Affiliation': 'ESTEVE Pharmaceuticals SA, Torre Esteve, Passeig de la Zona Franca, 109, 4ª Planta, 08038, Barcelona, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Iniesta', 'Affiliation': 'ESTEVE Pharmaceuticals SA, Torre Esteve, Passeig de la Zona Franca, 109, 4ª Planta, 08038, Barcelona, Spain. miniesta@esteve.com.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schug', 'Affiliation': 'SocraTec R&D GmbH, Im Setzling 35, 61440, Oberursel, Germany.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'SocraTec R&D GmbH, Im Setzling 35, 61440, Oberursel, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De la Torre', 'Affiliation': ""Grup de Recerca en Farmacologia Integrada i Neurociencia de Sistemes, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Dr Aiguader 88, Barcelona, Spain.""}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Schurad', 'Affiliation': 'Luye Pharma AG, Am Windfeld 35, 83714, Miesbach, Germany. bjoern.schurad@luyepharma.eu.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-022-00778-5']
1778,35696440,Integration of a multicomponent intervention for hypertension into primary healthcare services in Singapore-A cluster randomized controlled trial.,"BACKGROUND


Despite availability of clinical practice guidelines for hypertension management, blood pressure (BP) control remains sub-optimal (<30%) even in high-income countries. This study aims to assess the effectiveness of a potentially scalable multicomponent intervention integrated into primary care system compared to usual care on BP control.
METHODS AND FINDINGS


A cluster-randomized controlled trial was conducted in 8 government clinics in Singapore. The trial enrolled 916 patients aged ≥40 years with uncontrolled hypertension (systolic BP (SBP) ≥140 mmHg or diastolic BP (DBP) ≥90 mmHg). Multicomponent intervention consisted of physician training in risk-based treatment of hypertension, subsidized losartan-HCTZ single-pill combination (SPC) medications, nurse training in motivational conversations (MCs), and telephone follow-ups. Usual care (controls) comprised of routine care in the clinics, no MC or telephone follow-ups, and no subsidy on SPCs. The primary outcome was mean SBP at 24 months' post-baseline. Four clinics (447 patients) were randomized to intervention and 4 (469) to usual care. Patient enrolment commenced in January 2017, and follow-up was during December 2018 to September 2020. Analysis used intention-to-treat principles. The primary outcome was SBP at 24 months. BP at baseline, 12 and 24 months was modeled at the patient level in a likelihood-based, linear mixed model repeated measures analysis with treatment group, follow-up, treatment group × follow-up interaction as fixed effects, and random cluster (clinic) effects. A total of 766 (83.6%) patients completed 2-year follow-up. A total of 63 (14.1%) and 87 (18.6%) patients in intervention and in usual care, respectively, were lost to follow-up. At 24 months, the adjusted mean SBP was significantly lower in the intervention group compared to usual care (-3.3 mmHg; 95% CI: -6.34, -0.32; p = 0.03). The intervention led to higher BP control (odds ratio 1.51; 95% CI: 1.10, 2.09; p = 0.01), lower odds of high (>20%) 10-year cardiovascular risk score (OR 0.67; 95% CI: 0.47, 0.97; p = 0.03), and lower mean log albuminuria (-0.22; 95% CI: -0.41, -0.02; p = 0.03). Mean DBP, mortality rates, and serious adverse events including hospitalizations were not different between groups. The main limitation was no masking in the trial.
CONCLUSIONS


A multicomponent intervention consisting of physicians trained in risk-based treatment, subsidized SPC medications, nurse-delivered motivational conversation, and telephone follow-ups improved BP control and lowered cardiovascular risk. Wide-scale implementation of a multicomponent intervention such as the one in our trial is likely to reduce hypertension-related morbidity and mortality globally.
TRIAL REGISTRATION


Trial Registration: Clinicaltrials.gov NCT02972619.",2022,"The intervention led to higher BP control (odds ratio 1.51; 95% CI: 1.10, 2.09; p = 0.01), lower odds of high (>20%) 10-year cardiovascular risk score (OR 0.67; 95% CI: 0.47, 0.97; p = 0.03), and lower mean log albuminuria (","['8 government clinics in Singapore', 'A total of 766 (83.6%) patients completed 2-year follow-up', 'Four clinics (447 patients', '916 patients aged ≥40 years with uncontrolled hypertension (systolic BP (SBP) ≥140 mmHg or diastolic BP (DBP) ≥90 mmHg']","['Usual care (controls) comprised of routine care in the clinics, no MC or telephone follow-ups, and no subsidy on SPCs', 'multicomponent intervention', 'losartan-HCTZ single-pill combination (SPC) medications, nurse training', 'Multicomponent intervention consisted of physician training']","['BP', 'BP control and lowered cardiovascular risk', 'mean SBP', 'adjusted mean SBP', 'Mean DBP, mortality rates, and serious adverse events including hospitalizations', '10-year cardiovascular risk score']","[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",916.0,0.13012,"The intervention led to higher BP control (odds ratio 1.51; 95% CI: 1.10, 2.09; p = 0.01), lower odds of high (>20%) 10-year cardiovascular risk score (OR 0.67; 95% CI: 0.47, 0.97; p = 0.03), and lower mean log albuminuria (","[{'ForeName': 'Tazeen Hasan', 'Initials': 'TH', 'LastName': 'Jafar', 'Affiliation': 'Program in Health Services & Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Ngiap Chuan', 'Initials': 'NC', 'LastName': 'Tan', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Rupesh Madhukar', 'Initials': 'RM', 'LastName': 'Shirore', 'Affiliation': 'Program in Health Services & Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'John Carson', 'Initials': 'JC', 'LastName': 'Allen', 'Affiliation': 'Center for Quantitative Medicine, Office of Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Eric Andrew', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Program in Health Services & Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Siew Wai', 'Initials': 'SW', 'LastName': 'Hwang', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Agnes Ying Leng', 'Initials': 'AYL', 'LastName': 'Koong', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Peter Kirm Seng', 'Initials': 'PKS', 'LastName': 'Moey', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Gary Chun-Yun', 'Initials': 'GC', 'LastName': 'Kang', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Chris Wan Teng', 'Initials': 'CWT', 'LastName': 'Goh', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Reena Chandhini', 'Initials': 'RC', 'LastName': 'Subramanian', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Anandan Gerard', 'Initials': 'AG', 'LastName': 'Thiagarajah', 'Affiliation': 'National University Polyclinics, Singapore.'}, {'ForeName': 'Chandrika', 'Initials': 'C', 'LastName': 'Ramakrishnan', 'Affiliation': 'Program in Health Services & Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Ching Wee', 'Initials': 'CW', 'LastName': 'Lim', 'Affiliation': 'Program in Health Services & Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1004026']
1779,35696383,"Do book consumers discriminate against Black, female, or young authors?","The publishing industry shows marked evidence of both gender and racial discrimination. A rational explanation for this difference in treatment of both female and Black authors might relate to the taste-based preferences of book consumers, who might be less willing to pay for books by such authors. We ran a randomized experiment to test for the presence of discriminatory preferences by consumers based on authors' race, gender and/or age. We collected ratings of 25,201 book surveys across 9,072 subjects on Amazon's Mechanical Turk, making this study the largest experimental study of the book market to date. Subjects were presented with mocked-up book covers and descriptions from each of 14 fiction and non-fiction genres, with one of three possible titles per book randomly assigned. Using author names and photographs, we signaled authors' race, gender, and age and randomly assigned these combinations to each book presented to our subjects. We then asked subjects to rate their interest in purchasing the book, their evaluation of the author's credentials, and the amount they were willing to pay for the book. The experimental design of this study strived to eliminate the potential for proxy-based discrimination by providing book descriptions that detailed the authors' relevant professional experience. The large sample allowed for exploration of various types of taste-based discrimination observed in the literature, including discrimination against particular groups, homophily, and pro-social behavior. Overall, book consumers showed a willingness to pay approximately $0.50 or 3.5% more on average for books by Black authors and little, if any, practically meaningful discrimination based on age or gender. In other words, our study finds no and even contrary evidence of taste-based preferences by consumers that would rationalize the historic discriminatory treatment of Black or of female authors by publishers nor of discrimination based on an author's age.",2022,"Subjects were presented with mocked-up book covers and descriptions from each of 14 fiction and non-fiction genres, with one of three possible titles per book randomly assigned.","['Subjects were presented with mocked-up book covers and descriptions from each of 14 fiction and non-fiction genres, with one of three possible titles per book randomly assigned', ""25,201 book surveys across 9,072 subjects on Amazon's Mechanical Turk""]",[],[],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0887933', 'cui_str': 'Fictional Works'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]",[],[],,0.0326466,"Subjects were presented with mocked-up book covers and descriptions from each of 14 fiction and non-fiction genres, with one of three possible titles per book randomly assigned.","[{'ForeName': 'Dana B', 'Initials': 'DB', 'LastName': 'Weinberg', 'Affiliation': 'Department of Sociology, Queens College, CUNY, Queens, NY, United States of America.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kapelner', 'Affiliation': 'Department of Mathematics, Queens College, CUNY, Queens, NY, United States of America.'}]",PloS one,['10.1371/journal.pone.0267537']
1780,35696382,PREHOSPTIAL LOW TITER GROUP O WHOLE BLOOD IS FEASIBLE AND SAFE: RESULTS OF A PROSPECTIVE RANDOMIZED PILOT TRIAL.,,2022,,[],[],[],[],[],[],,0.00499693,,"[{'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Professor Surg. & Critical Care, University of Pittsburgh Medical Center, Dept. of Surgery, 200 Lothrop street, Suite F1266 PUH, Pittsburgh, PA 15213 sperryjl@upmc.edu.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003686']
1781,35696375,Barriers and facilitators in the delivery of a proportionate universal parenting program model (E-SEE Steps) in community family services.,"BACKGROUND


A proportionate universal (PU) approach to early years' service provision has been advocated to improve children's health and development and to reduce health inequality, by ensuring that services provide timely and high-quality parenting support commensurate with need. Process-oriented research is critical to examine the factors that contribute to, or hinder, the effective delivery/implementation of such a model in community-based family services. This study aimed to assess the delivery, acceptability and feasibility of a new PU parenting intervention model (called E-SEE Steps), using the Incredible Years® (IY) parent program, when delivered by trained health/family service staff in three ""steps""-one universal step (the IY Babies Book), and two targeted steps (group-based IY Infant and Toddler programs).
METHODS


An embedded mixed-methods process evaluation within a pragmatic parallel two-arm, assessor blinded, randomized controlled trial was conducted in community services in four local authorities in England. The process evaluation used qualitative data gathered via interviews and focus groups with intervention arm parents who were offered the targeted steps (n = 29), practitioners (n = 50), service managers (n = 7) and IY program mentors (n = 3). This was supplemented by quantitative data collected using group leader pre-training (n = 50) and post-delivery (n = 39) questionnaires, and research notes of service design decisions.
RESULTS


The E-SEE Steps model was acceptable to most parents, particularly when it was accompanied by engagement strategies that supported attendance, such as providing childcare. Practitioners also highlighted the positive development opportunities provided by the IY training and supervision. However, participant views did not support the provision of the IY Babies book as a standalone universal component, and there were barriers to eligible parents-particularly those with low mood-taking up the targeted programs. Service providers struggled to align the PU model with their commissioned service contracts and with their staff capacity to engage appropriate parents, including tackling common barriers to attendance.
CONCLUSIONS


Despite general enthusiasm and support for delivering high-quality parenting programs in community services in the England, several barriers exist to successfully delivering IY in a proportionate universal model within current services/systems.",2022,"The E-SEE Steps model was acceptable to most parents, particularly when it was accompanied by engagement strategies that supported attendance, such as providing childcare.","['community services in four local authorities in England', 'community family services']",['new PU parenting intervention model (called E-SEE Steps'],[],"[{'cui': 'C0009482', 'cui_str': 'Community Services'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",[],50.0,0.0437322,"The E-SEE Steps model was acceptable to most parents, particularly when it was accompanied by engagement strategies that supported attendance, such as providing childcare.","[{'ForeName': 'Vashti', 'Initials': 'V', 'LastName': 'Berry', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, Devon, United Kingdom.'}, {'ForeName': 'Siobhan B', 'Initials': 'SB', 'LastName': 'Mitchell', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, Devon, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blower', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Whittaker', 'Affiliation': 'School of Nursing, University of Central Lancashire, Preston, Lancashire, United Kingdom.'}, {'ForeName': 'Kath', 'Initials': 'K', 'LastName': 'Wilkinson', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, Devon, United Kingdom.'}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'McGilloway', 'Affiliation': 'Centre for Mental Health and Community Research, Department of Psychology and Social Sciences Institute, Maynooth University, Maynooth, Co Kildare, Republic of Ireland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mason-Jones', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Rachel Margaret', 'Initials': 'RM', 'LastName': 'Carr', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, United Kingdom.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Bywater', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0265946']
1782,35696601,"Local Vibration Therapy, Oxygen Resaturation Rate, and Muscle Strength After Exercise-Induced Muscle Damage.","CONTEXT


Exercise-induced muscle damage (EIMD) is associated with transient reductions in strength and athletic performance. Muscle microvascular damage and disruption of blood flow are believed to be among the causes. Previous researchers reported modulations in muscle blood flow, oxygenation, and strength with vibration therapy (VT).
OBJECTIVE


To observe whether local VT alleviated the impairments and hemodynamic changes associated with EIMD.
DESIGN


Controlled laboratory study.
SETTING


Laboratory and public gymnasium.
PATIENTS OR OTHER PARTICIPANTS


A total of 10 healthy participants (6 men and 4 women; age = 38 ± 15 years; height = 1.72 ± 0.48 m; mass = 72.0 ± 10.4 kg) were randomized into experimental (VT) and control groups.
INTERVENTIONS


Both groups performed 10 sets of 10 eccentric wrist flexions at 70% of their 1-repetition maximum to induce muscle damage. Subsequent assessment of flexor carpus ulnaris muscle oxygen saturation and wrist-flexor strength occurred at 1, 24, and 48 hours postexercise. The experimental group underwent 10 minutes of local VT (45 Hz) starting 1 hour postexercise and applied twice daily (separated by 8 hours) for 48 hours during habitual waking hours. The control group received no local VT.
MAIN OUTCOME MEASURE(S)


Resting muscle oxygen saturation (SmO2), grip strength, and muscle oxygen desaturation and resaturation rates.
RESULTS


No difference in SmO2 resaturation was evident over time (P > .05), but the VT group had a greater resaturation rate than the control group at 1 hour (P = .007, d = 2.6), 24 hours (P = .001, d = 3.1), and 48 hours (P = .035, d = 1.7) post-EIMD. No difference in grip strength was observed pre-EIMD, but the VT group demonstrated greater strength at 1 hour (P = .004), 24 hours (P = .031), and 48 hours (P = .021) post-EIMD than did the control group.
CONCLUSIONS


Local VT successfully attenuated the effects of EIMD and increased SmO2 resaturation in flexor carpus ulnaris muscles. Including local VT as part of a recovery protocol post-EIMD could be beneficial for rehabilitation and strength training purposes.",2022,"No difference in SmO2 resaturation was evident over time (P > .05), but the VT group had a greater resaturation rate than the control group at 1 hour (P = .007, d = 2.6), 24 hours (P =","['Laboratory and public gymnasium', '10 healthy participants (6 men and 4 women; age = 38 ± 15 years; height = 1.72 ± 0.48 m; mass = 72.0 ± 10.4 kg']","['local VT', 'no local VT']","['SmO2 resaturation', 'grip strength', 'Local Vibration Therapy, Oxygen Resaturation Rate, and Muscle Strength', 'Resting muscle oxygen saturation (SmO2), grip strength, and muscle oxygen desaturation and resaturation rates', 'Muscle microvascular damage and disruption of blood flow', 'muscle blood flow, oxygenation, and strength with vibration therapy (VT', 'greater strength', 'resaturation rate', 'flexor carpus ulnaris muscle oxygen saturation and wrist-flexor strength']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442572', 'cui_str': 'Gymnasium'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517513', 'cui_str': '1.72'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C5191376', 'cui_str': '10.4'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}]",10.0,0.0444026,"No difference in SmO2 resaturation was evident over time (P > .05), but the VT group had a greater resaturation rate than the control group at 1 hour (P = .007, d = 2.6), 24 hours (P =","[{'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Percival', 'Affiliation': 'Department of Sport and Exercise Sciences, Institute of Sport, Manchester Metropolitan University, United Kingdom.'}, {'ForeName': 'Dave T', 'Initials': 'DT', 'LastName': 'Sims', 'Affiliation': 'Department of Sport and Exercise Sciences, Institute of Sport, Manchester Metropolitan University, United Kingdom.'}, {'ForeName': 'Georgina K', 'Initials': 'GK', 'LastName': 'Stebbings', 'Affiliation': 'Department of Sport and Exercise Sciences, Institute of Sport, Manchester Metropolitan University, United Kingdom.'}]",Journal of athletic training,['10.4085/1062-6050-0064.21']
1783,35696838,Changes in positive and negative affect following prolonged exposure for PTSD comorbid with alcohol use disorder: Secondary analysis of a randomized clinical trial.,"Many individuals with posttraumatic stress disorder (PTSD) report increased negative affect (NA) and decreased positive affect (PA). Little is known about whether treatments for PTSD improve PA. We conducted a secondary analysis of a randomized clinical trial comparing integrated exposure therapy (I-PE) to integrated coping skills therapy (I-CS) for comorbid PTSD and alcohol use disorder (AUD). Veterans (N = 119) were randomized to 12-16 weeks of I-PE (n = 63) or I-CS (n = 56) and completed PA and NA measures at baseline, post-treatment, and 3- and 6-month follow-up. The analysis sample included 80 (67%) participants with the required data. A significantly greater proportion of the full sample met ""clinical"" levels (i.e., ±0.5 SD away from a general population mean) for NA than PA at baseline, but not at post-treatment. At post-treatment, the I-PE group demonstrated significantly greater change in NA than PA. Change in NA compared to PA did not significantly differ in the I-CS group. In the full sample, NA reduction was significantly larger than PA elevation post-treatment; change in NA, but not PA, was independently associated with symptom changes. Results provide an initial evaluation of treatment efficacy in concurrently repairing PA and NA and suggest room to improve both in individuals with PTSD and AUD.",2022,"In the full sample, NA reduction was significantly larger than PA elevation post-treatment; change in NA, but not PA, was independently associated with symptom changes.","['comorbid PTSD and alcohol use disorder (AUD', 'The analysis sample included 80 (67%) participants with the required data', 'Veterans (N\xa0=\xa0119', 'individuals with posttraumatic stress disorder (PTSD']",['integrated exposure therapy (I-PE) to integrated coping skills therapy (I-CS'],"['full sample met ""clinical"" levels']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C1303103', 'cui_str': 'Sample analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",119.0,0.0458401,"In the full sample, NA reduction was significantly larger than PA elevation post-treatment; change in NA, but not PA, was independently associated with symptom changes.","[{'ForeName': 'Samantha N', 'Initials': 'SN', 'LastName': 'Hoffman', 'Affiliation': 'San Diego State University/University of California San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Lyons', 'Affiliation': 'San Diego State University/University of California San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'Veterans Affairs San Diego Healthcare System, San Diego, CA, USA; University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Taylor', 'Affiliation': 'University of California San Diego, San Diego, CA, USA. Electronic address: c1taylor@health.ucsd.edu.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'Veterans Affairs San Diego Healthcare System, San Diego, CA, USA; University of California San Diego, San Diego, CA, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2022.104097']
1784,35696837,Impacts of imagery-enhanced versus verbally-based cognitive behavioral group therapy on psychophysiological parameters in social anxiety disorder: Results from a randomized-controlled trial.,"Social anxiety disorder (SAD) is associated with marked physiological reactivity in social-evaluative situations. However, objective measurement of biomarkers is rarely evaluated in treatment trials, despite potential utility in clarifying disorder-specific physiological correlates. This randomized controlled trial sought to examine the differential impact of imagery-enhanced vs. verbal-based cognitive behavioral group therapy (IE-CBGT, n = 53; VB-CBGT, n = 54) on biomarkers of emotion regulation and arousal during social stress in people with SAD (pre- and post-treatment differences in heart rate variability (HRV) and skin conductance). We acquired psychophysiological data from randomized participants across four social stress test phases (baseline, speech preparation, speech, interaction) at pre-treatment, and 1- and 6-months post-treatment. Analyses revealed that IE-CBGT selectively attenuated heart rate as indexed by increases in median heart rate interval (median-RR) compared to VB-CBGT at post-treatment, whereas one HRV index showed a larger increase in the VB-CBGT condition before but not after controlling for median-RR. Other psychophysiological indices did not differ between conditions. Lower sympathetic arousal in the IE-CBGT condition may have obviated the need for parasympathetic downregulation, whereas the opposite was true for VB-CBGT. These findings provide preliminary insights into the impact of imagery-enhanced and verbally-based psychotherapy for SAD on emotion regulation biomarkers.",2022,These findings provide preliminary insights into the impact of imagery-enhanced and verbally-based psychotherapy for SAD on emotion regulation biomarkers.,['social anxiety disorder'],"['imagery-enhanced versus verbally-based cognitive behavioral group therapy', 'imagery-enhanced vs. verbal-based cognitive behavioral group therapy (IE-CBGT, n\xa0=\xa053; VB-CBGT, n\xa0=\xa054']","['heart rate', 'biomarkers of emotion regulation and arousal during social stress', 'VB-CBGT condition', 'Lower sympathetic arousal', 'median heart rate interval', 'heart rate variability (HRV) and skin conductance', 'Social anxiety disorder (SAD']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",,0.107385,These findings provide preliminary insights into the impact of imagery-enhanced and verbally-based psychotherapy for SAD on emotion regulation biomarkers.,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'McEvoy', 'Affiliation': 'Discipline of Psychology, School of Population Health, Curtin University, Perth, WA, Australia; Centre for Clinical Interventions, Perth, WA, Australia. Electronic address: peter.mcevoy@curtin.edu.au.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Hyett', 'Affiliation': 'Discipline of Psychology, School of Population Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Johnson', 'Affiliation': 'Discipline of Psychology, School of Population Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Erceg-Hurn', 'Affiliation': 'Discipline of Psychology, School of Population Health, Curtin University, Perth, WA, Australia; Centre for Clinical Interventions, Perth, WA, Australia.'}, {'ForeName': 'Patrick J F', 'Initials': 'PJF', 'LastName': 'Clarke', 'Affiliation': 'Discipline of Psychology, School of Population Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Kyron', 'Affiliation': 'Discipline of Psychology, School of Population Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Bank', 'Affiliation': 'Discipline of Psychology, School of Population Health, Curtin University, Perth, WA, Australia; Centre for Clinical Interventions, Perth, WA, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Haseler', 'Affiliation': 'School of Allied Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Saulsman', 'Affiliation': 'School of Psychological Science, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Moulds', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Grisham', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moscovitch', 'Affiliation': 'Centre for Mental Health Research and Treatment, Department of Psychology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Ottmar V', 'Initials': 'OV', 'LastName': 'Lipp', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}]",Behaviour research and therapy,['10.1016/j.brat.2022.104131']
1785,35696756,Developing mental number line games to improve young children's number knowledge and basic arithmetic skills.,"The learning of number knowledge in childhood may directly influence children's mathematics learning ability in subsequent periods. Previous studies also show that the difficulties in mathematics learning faced by schoolchildren are mainly rooted in the lack of number knowledge in early childhood. Focusing on the development of numerical knowledge and basic arithmetic skills in early childhood, this study designed a linear number line game based on the theory of the mental number line. Accordingly, this study examined the effectiveness of the linear number line game in children's learning of number concepts and arithmetic skills and compared the effectiveness of the linear number line game with that of two other games (a nonlinear number line game and a non-number-line game). This study adopted a quasi-experimental research design. A total of 140 young children from remote areas of eastern Taiwan participated and were divided into three experimental groups and one control group, and a pretest-posttest experiment was conducted. The experimental results showed that the linear number line game could help children to acquire numerical knowledge effectively, especially in number line estimation compared with other experimental groups. In terms of the learning effectiveness of basic arithmetic skills (e.g., addition, subtraction), the two number line games (linear and nonlinear number line games) are significantly superior to the non-number-line game (traditional number decomposition and synthesis game). This study recommends that preschool teachers use linear number line games to improve children's numerical knowledge and arithmetic skills.",2022,"The experimental results showed that the linear number line game could help children to acquire numerical knowledge effectively, especially in number line estimation compared with other experimental groups.","['140 young children from remote areas of eastern Taiwan participated', 'preschool teachers']","['linear number line game', 'basic arithmetic skills (e.g., addition, subtraction), the two number line games (linear and nonlinear number line games']",[],"[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],140.0,0.0371771,"The experimental results showed that the linear number line game could help children to acquire numerical knowledge effectively, especially in number line estimation compared with other experimental groups.","[{'ForeName': 'Chien-Heng', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Early Childhood Education, National Dong Hwa University, Shoufeng, Hualien 97401, Taiwan. Electronic address: chienlin@gms.ndhu.edu.tw.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2022.105479']
1786,35696706,"""My Surgical Success"": Feasibility and Impact of a Single-Session Digital Behavioral Pain Medicine Intervention on Pain Intensity, Pain Catastrophizing, and Time to Opioid Cessation After Orthopedic Trauma Surgery-A Randomized Trial.","BACKGROUND


Behavioral pain treatments may improve postsurgical analgesia and recovery; however, effective and scalable options are not widely available. This study tested a digital perioperative behavioral medicine intervention in orthopedic trauma surgery patients for feasibility and efficacy for reducing pain intensity, pain catastrophizing, and opioid cessation up to 3 months after surgery.
METHODS


A randomized controlled clinical trial was conducted at an orthopedic trauma surgery unit at a major academic hospital to compare a digital behavioral pain management intervention (""My Surgical Success"" [MSS]) to a digital general health education (HE) intervention (HE; no pain management skills). The enrolled sample included 133 patients; 84 patients were randomized (MSS, N = 37; HE, N = 47) and completed study procedures. Most patients received their assigned intervention within 3 days of surgery (85%). The sample was predominantly male (61.5%), White (61.9%), and partnered (65.5%), with at least a bachelor's degree (69.0%). Outcomes were collected at 1-3 months after intervention through self-report e-surveys and electronic medical record review; an intention-to-treat analytic framework was applied. Feasibility was dually determined by the proportion of patients engaging in their assigned treatment and an application of an 80% threshold for patient-reported acceptability. We hypothesized that MSS would result in greater reductions in pain intensity and pain catastrophizing after surgery and earlier opioid cessation compared to the digital HE control group.
RESULTS


The engagement rate with assigned interventions was 63% and exceeded commonly reported rates for fully automated Internet-based e-health interventions. Feasibility was demonstrated for the MSS engagers, with >80% reporting treatment acceptability. Overall, both groups improved in the postsurgical months across all study variables. A significant interaction effect was found for treatment group over time on pain intensity, such that the MSS group evidenced greater absolute reductions in pain intensity after surgery and up to 3 months later (treatment × time fixed effects; F[215] = 5.23; P = .024). No statistically significant between-group differences were observed for time to opioid cessation or for reductions in pain catastrophizing (F[215] = 0.20; P = .653), although the study sample notably had subclinical baseline pain catastrophizing scores (M = 14.10; 95% confidence interval, 11.70-16.49).
CONCLUSIONS


Study findings revealed that a fully automated behavioral pain management skills intervention (MSS) may be useful for motivated orthopedic trauma surgery patients and reduce postsurgical pain up to 3 months. MSS was not associated with reduced time to opioid cessation compared to the HE control intervention.",2022,"No statistically significant between-group differences were observed for time to opioid cessation or for reductions in pain catastrophizing (F[215] = 0.20; P = .653), although the study sample notably had subclinical baseline pain catastrophizing scores (M = 14.10; 95% confidence interval, 11.70-16.49).
","['orthopedic trauma surgery unit at a major academic hospital to compare a', ""The sample was predominantly male (61.5%), White (61.9%), and partnered (65.5%), with at least a bachelor's degree (69.0"", 'orthopedic trauma surgery patients', '133 patients; 84 patients were randomized (MSS, N = 37; HE, N = 47) and completed study procedures']","['Single-Session Digital Behavioral Pain Medicine Intervention', 'digital behavioral pain management intervention (""My Surgical Success"" [MSS', 'behavioral pain management skills intervention (MSS', 'MSS', 'digital perioperative behavioral medicine intervention', 'digital general health education (HE) intervention (HE']","['pain intensity', 'pain intensity, pain catastrophizing, and opioid cessation', 'subclinical baseline pain catastrophizing scores', 'postsurgical pain', 'Pain Intensity, Pain Catastrophizing, and Time to Opioid Cessation', 'pain catastrophizing', 'time to opioid cessation', 'pain intensity and pain catastrophizing']","[{'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004937', 'cui_str': 'Medicine, Behavioral'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",133.0,0.174406,"No statistically significant between-group differences were observed for time to opioid cessation or for reductions in pain catastrophizing (F[215] = 0.20; P = .653), although the study sample notably had subclinical baseline pain catastrophizing scores (M = 14.10; 95% confidence interval, 11.70-16.49).
","[{'ForeName': 'Maisa S', 'Initials': 'MS', 'LastName': 'Ziadni', 'Affiliation': 'From the Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Dokyoung S', 'Initials': 'DS', 'LastName': 'You', 'Affiliation': 'From the Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Keane', 'Affiliation': 'From the Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Salazar', 'Affiliation': 'Department of Orthopaedic Surgery, Orthopaedic Trauma Service.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Jaros', 'Affiliation': 'Department of Epidemiology, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Jesmin', 'Initials': 'J', 'LastName': 'Ram', 'Affiliation': 'From the Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'From the Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Tanner', 'Affiliation': 'Department of Orthopaedic Surgery, Orthopaedic Trauma Service.'}, {'ForeName': 'Vafi', 'Initials': 'V', 'LastName': 'Salmasi', 'Affiliation': 'From the Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gardner', 'Affiliation': 'Department of Orthopaedic Surgery, Orthopaedic Trauma Service.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'From the Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000006088']
1787,35699999,Effects of a multicomponent intervention on cardiovascular risk factors in overweight children: a randomized clinical trial in light of complex systems.,"Analyzing the effects of interventions from a theoretical and statistical perspective that allows understanding these dynamic relationships of obesity etiology can be a more efficient and innovative way of understanding the phenomenon's complexity. Thus, we aimed to analyze the pattern of cardiovascular risk factors between-participants, and the effects within-participants of a multidisciplinary intervention on cardiovascular risk factors in overweight children. This is a randomized clinical trial, and 41 participated in this study. A multicomponent intervention (physical activities, nutritional and psychological counseling) was performed for 10 weeks. Anthropometric and hemodynamics measurements, lipid and glucose profile, cardiorespiratory fitness, and left ventricular mass were evaluated. A network analysis was done. Considering patterns in the network at baseline, WC, WHR, BMI, and Fat were the main variables for cardiovascular risks. Group was the most critical variable in the within-participant network. Participating in a multicomponent intervention and decreasing body fat promoted beneficial cardiovascular factors.",2022,"Considering patterns in the network at baseline, WC, WHR, BMI, and Fat were the main variables for cardiovascular risks.",['overweight children'],"['multidisciplinary intervention', 'multicomponent intervention', 'multicomponent intervention (physical activities, nutritional and psychological counseling']","['Anthropometric and hemodynamics measurements, lipid and glucose profile, cardiorespiratory fitness, and left ventricular mass', 'cardiovascular risk factors', 'WC, WHR, BMI, and Fat']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0474178', 'cui_str': 'Psychological counseling'}]","[{'cui': 'C0204901', 'cui_str': 'Hemodynamic measurements'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0563449,"Considering patterns in the network at baseline, WC, WHR, BMI, and Fat were the main variables for cardiovascular risks.","[{'ForeName': 'Thaynã Alves', 'Initials': 'TA', 'LastName': 'Bezerra', 'Affiliation': 'Department of Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Anastácio Neco de', 'Initials': 'AN', 'LastName': 'Souza Filho', 'Affiliation': 'Department of Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Maria Luiza Felix', 'Initials': 'MLF', 'LastName': 'Pessoa', 'Affiliation': 'Department of Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Paulo Felipe', 'Initials': 'PF', 'LastName': 'Ribeiro Bandeira', 'Affiliation': 'Department of Physical Education, Regional University of Cariri, Crato, Brazil.'}, {'ForeName': 'Luciana Gatto Azevedo', 'Initials': 'LGA', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'José Fernando Vila Nova de', 'Initials': 'JFVN', 'LastName': 'Moraes', 'Affiliation': 'Department of Physical Education, Federal University of Vale do São Francisco, Petrolina, Brazil.'}, {'ForeName': 'Clarice Maria de Lucena', 'Initials': 'CML', 'LastName': 'Martins', 'Affiliation': 'Department of Physical Education, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Ferdinando Oliveira', 'Initials': 'FO', 'LastName': 'Carvalho', 'Affiliation': 'Department of Physical Education, Federal University of Vale do São Francisco, Petrolina, Brazil.'}]",International journal of environmental health research,['10.1080/09603123.2022.2088704']
1788,35699989,Virtual Reality Training Using Nintendo Wii Games for Patients With Stroke: Randomized Controlled Trial.,"BACKGROUND


Stroke is a leading cause of disability. It is difficult to devise an optimal rehabilitation plan once stroke survivors are back home. Conventional rehabilitative therapies are extensively used in patients with stroke to recover motor functioning and disability, but these are arduous and expensive. Virtual reality (VR) video games inspire patients to get involved in their therapeutic exercise routine in a fun way. VR in the form of games provides a fruitful, secure, and challenging learning environment for motor control and neural plasticity development in rehabilitation. The effects of upper limb sensorimotor functioning and balance are the main focus of this trial.
OBJECTIVE


The aim of this study is to compare the effects of VR training and routine physical therapy on balance and upper extremity sensorimotor function in patients with stroke.
METHODS


It was a single assessor-blinded randomized clinical trial. A total of 74 participants with their first chronic stroke were included and rehabilitated in a clinical setting. The lottery method was used to randomly assign patients to either the VR group (n=37) or the routine physical therapy group (n=37). The VR group received a 1-hour session of VR training for 3 weekdays over 6 weeks, and the routine physical therapy group received different stretching and strengthening exercises. The outcome measuring tools were the Berg Balance Scale for balance and the Fugl-Meyer Assessment (upper extremity) scale for sensorimotor, joint pain, and range assessment. The assessment was done at the start of treatment and after the 6 weeks of intervention. Data analysis was done using SPSS 22.
RESULTS


The trial was completed by 68 patients. A significant difference between the two groups was found in the Berg Balance Scale score (P<.001), Fugl-Meyer Assessment for motor function (P=.03), and Fugl-Meyer Assessment for joint pain and joint range (P<.001); however, no significant difference (P=.19) in the Fugl-Meyer Assessment for upper extremity sensation was noted.
CONCLUSIONS


VR training is helpful for improving balance and function of the upper extremities in the routine life of patients with stroke; although, it was not found to be better than conventional training in improving upper limb sensation. VR training can be a better option in a rehabilitation plan designed to increase functional capability.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials RCT20190715044216N1; https://www.irct.ir/user/trial/40898/view.",2022,"A significant difference between the two groups was found in the Berg Balance Scale score (P<.001), Fugl-Meyer Assessment for motor function (P=.03), and Fugl-Meyer Assessment for joint pain and joint range (P<.001); however, no significant difference (P=.19) in the Fugl-Meyer Assessment for upper extremity sensation was noted.
","['patients with stroke', '68 patients', 'Patients With Stroke', '74 participants with their first chronic stroke were included and rehabilitated in a clinical setting']","['Virtual reality (VR) video games', 'conventional training', 'routine physical therapy group received different stretching and strengthening exercises', 'VR training', 'Virtual Reality Training', 'routine physical therapy', 'VR training and routine physical therapy', 'Nintendo Wii Games', 'Conventional rehabilitative therapies']","['Fugl-Meyer Assessment for joint pain and joint range', 'Fugl-Meyer Assessment for upper extremity sensation', 'Berg Balance Scale score (P<.001), Fugl-Meyer Assessment for motor function', 'Berg Balance Scale for balance and the Fugl-Meyer Assessment (upper extremity) scale for sensorimotor, joint pain, and range assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",74.0,0.0134833,"A significant difference between the two groups was found in the Berg Balance Scale score (P<.001), Fugl-Meyer Assessment for motor function (P=.03), and Fugl-Meyer Assessment for joint pain and joint range (P<.001); however, no significant difference (P=.19) in the Fugl-Meyer Assessment for upper extremity sensation was noted.
","[{'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Anwar', 'Affiliation': 'University Institute of Physical Therapy, University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Karimi', 'Affiliation': 'University Institute of Physical Therapy, University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'University Institute of Physical Therapy, University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Syed Amir', 'Initials': 'SA', 'LastName': 'Gilani', 'Affiliation': 'University Institute of Physical Therapy, University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Kehkshan', 'Initials': 'K', 'LastName': 'Khalid', 'Affiliation': 'Department of Physical Therapy, Avicenna Medical College, Lahore, Pakistan.'}, {'ForeName': 'Ahmed Sohaib', 'Initials': 'AS', 'LastName': 'Aslam', 'Affiliation': 'Department of Physical Therapy, Kanaan Healthcare Center, Lahore, Pakistan.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Hanif', 'Affiliation': 'University Institute of Physical Therapy, University of Lahore, Lahore, Pakistan.'}]",JMIR serious games,['10.2196/29830']
1789,35697550,"Oral health-related quality of life of conventional removable partial dentures, unilateral nonmetal clasp dentures, and shortened dental arch with 2- or 3-tooth unilateral distal extension tooth loss in the mandible: A randomized, crossover, clinical trial.","STATEMENT OF PROBLEM


Conventional removable partial dentures with metal clasps are still a common option for patients with distal-extension tooth loss. However, unilateral nonmetal clasp dentures fabricated by using a thermoplastic denture base resin are increasingly being used. Furthermore, the shortened dental arch concept remains controversial, in spite of being advocated for many years. Nevertheless, these treatment options remain controversial, particularly in patients with the loss of a few distal teeth unilaterally.
PURPOSE


The purpose of this randomized, crossover, clinical trial was to investigate the oral health-related quality of life of participants who requested a new dental prosthesis (unilateral nonmetal clasp dentures or conventional removable partial dentures) at a private practice.
MATERIAL AND METHODS


A 3-period, randomized, crossover design was used in a within-subject, controlled, clinical trial. Twenty-four participants (mean age 59.0 years [7 men: 62.6 {45-85} years; 17 women: 57.5 {24-75} years]) were enrolled. All experimental procedures were approved by the Ethics Committee of Nagasaki University Hospital (#15022313) and registered in the International Standard Randomized Controlled Trial Number registry (ISRCTN49105064). All participants were fully dentate in the maxilla and had unilateral distal-extension loss of 2 or 3 teeth in the mandible. Participants were allocated to 1 of 6 groups and treated with prescribed options in accordance with their allocated sequences and used a dental prosthesis or nothing for 2-week periods. At the end of each intervention, the participants were asked to answer the Oral Health Impact Profile questionnaire. Differences in Oral Health Impact Profile scores among groups were estimated with a mixed-effects model (α=.05).
RESULTS


Total Oral Health Impact Profile scores were higher for unilateral nonmetal clasp dentures (P=.002) and shortened dental arch (P=.049) than for conventional removable partial dentures, with medium and small effects. The unilateral nonmetal clasp dentures had a similar effect compared with shortened dental arch (P>.05). unilateral nonmetal clasp dentures (P=.011) and shortened dental arch (P=.005) demonstrated medium effects in the oral function dimension compared with conventional removable partial dentures. Unilateral nonmetal clasp dentures exhibited large and medium effects in the orofacial appearance dimension compared with conventional removable partial dentures (P=.001) and shortened dental arch (P=.006). In the orofacial pain dimension, shortened dental arch showed effects similar to those of conventional removable partial dentures and unilateral nonmetal clasp dentures (P>.05), and no significant differences were observed in the psychosocial impact dimension (P>.05), but the unilateral nonmetal clasp denture score was lower than the conventional removable partial denture score, with a small effect. Men had significantly lower total Oral Health Impact Profile scores for shortened dental arch than women (P=.033).
CONCLUSIONS


Unilateral nonmetal clasp dentures and shortened dental arch were better than conventional removable partial dentures for the oral health-related quality of life of individuals with unilateral distal-extension tooth loss in the mandible, and sex had a significant effect on removable prosthetic planning.",2022,"RESULTS


Total Oral Health Impact Profile scores were higher for unilateral nonmetal clasp dentures (P=.002) and shortened dental arch (P=.049) than for conventional removable partial dentures, with medium and small effects.","['Oral health-related quality of life of conventional removable partial dentures, unilateral nonmetal clasp dentures, and shortened dental arch with 2- or 3-tooth unilateral distal extension tooth loss in the mandible', 'patients with the loss of a few distal teeth unilaterally', 'Twenty-four participants (mean age 59.0 years [7 men: 62.6 {45-85} years; 17 women: 57.5 {24-75} years]) were enrolled', 'All participants were fully dentate in the maxilla and had unilateral distal-extension loss of 2 or 3 teeth in the mandible', 'patients with distal-extension tooth loss', 'participants who requested a new dental prosthesis (unilateral nonmetal clasp dentures or conventional removable partial dentures) at a private practice']",['conventional removable partial dentures'],"['Total Oral Health Impact Profile scores', 'psychosocial impact dimension', 'oral health-related quality of life', 'Oral Health Impact Profile scores', 'orofacial appearance dimension', 'unilateral nonmetal clasp denture score', 'unilateral nonmetal clasp dentures', 'total Oral Health Impact Profile scores', 'Oral Health Impact Profile questionnaire']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0011325', 'cui_str': 'Dental arch structure'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",24.0,0.102886,"RESULTS


Total Oral Health Impact Profile scores were higher for unilateral nonmetal clasp dentures (P=.002) and shortened dental arch (P=.049) than for conventional removable partial dentures, with medium and small effects.","[{'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Nakai', 'Affiliation': 'Clinical Professor, Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan; Private practice, Kyoto, Japan. Electronic address: nakai@ndo-kyoto.jp.'}, {'ForeName': 'Tadafumi', 'Initials': 'T', 'LastName': 'Kurogi', 'Affiliation': 'Assistant Professor, Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Murata', 'Affiliation': 'Professor, Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2021.07.014']
1790,35697547,"Intraoperative lidocaine infusion in patients undergoing pancreatectomy for pancreatic cancer: a mechanistic, multicentre randomised clinical trial.","BACKGROUND


Intravenous lidocaine has been postulated to improve long-term survival after surgery for pancreatic cancer through anti-inflammatory effects, anti-tumour effects, or both. We investigated whether intraoperative lidocaine improves survival after pancreatectomy for pancreatic cancer and whether lidocaine modified the formation of neutrophil extracellular traps (NETs), high levels of which are associated with poor prognosis.
METHODS


Patients undergoing pancreatectomy were randomly assigned to i.v. lidocaine (continuous intraoperative infusion of 2 mg kg -1  h -1 , after 1.5 mg kg -1  bolus at induction of anaesthesia) or saline placebo. The co-primary outcomes were survival/disease-free survival 3 yr after surgery. Secondary outcomes (masked to treatment allocation) included intraoperative opioid (sufentanil) consumption, postoperative complications, and circulating and tumour-associated NETs (immunofluorescence assay, enzyme-linked immune assay, or both).
RESULTS


A total of 563 participants (34.6% female; median age, 64 yr) completed 3 yr of clinical follow-up. Overall, 283 participants were randomised to lidocaine infusion, compared with 280 participants randomised to placebo. Infusion of lidocaine did not alter overall (hazard ratio [HR]=0.98; 95% confidence interval [CI], 0.81-1.17; P=0.79) or disease-free survival (HR=0.91; 95% CI, 0.71-1.17; P=0.44). Mean intraoperative sufentanil consumption was reduced by lidocaine infusion (47.6 μg [4.6]), compared with placebo (68.4 μg [4.8]; P<0.001), but postoperative complications and length of hospital stay were similar between groups. Circulating NETs were lower after lidocaine infusion up to 3 days after surgery, but tumour-associated NETs were not altered by intraoperative treatment.
CONCLUSION


In patients undergoing pancreatectomy for pancreatic cancer, intraoperative infusion of lidocaine did not improve overall or disease-free survival. Reduced formation of circulating NETs was absent in pancreatic tumour tissue.
CLINICAL TRIAL REGISTRATION


NCT03245346; updated in Chi-CTR-2000035469.",2022,"Circulating NETs were lower after lidocaine infusion up to 3 days after surgery, but tumour-associated NETs were not altered by intraoperative treatment.
","['patients undergoing pancreatectomy for pancreatic cancer', 'Patients undergoing pancreatectomy', '563 participants (34.6% female; median age, 64 yr) completed 3 yr of clinical follow-up', '283 participants']","['Intraoperative lidocaine infusion', 'lidocaine', 'saline placebo', 'intraoperative lidocaine', 'placebo']","['Circulating NETs', 'Mean intraoperative sufentanil consumption', 'survival', 'overall or disease-free survival', 'Reduced formation of circulating NETs', 'postoperative complications and length of hospital stay', 'disease-free survival', 'survival/disease-free survival', 'intraoperative opioid (sufentanil) consumption, postoperative complications, and circulating and tumour-associated NETs (immunofluorescence assay, enzyme-linked immune assay, or both']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030279', 'cui_str': 'Pancreatectomy'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4708786', 'cui_str': '283'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C3850088', 'cui_str': 'NETs (Neutrophil Extracellular Traps)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0016318', 'cui_str': 'Fluorescent identification of anti-nuclear antibody'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]",563.0,0.806367,"Circulating NETs were lower after lidocaine infusion up to 3 days after surgery, but tumour-associated NETs were not altered by intraoperative treatment.
","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesiology, Zhongshan Hospital, Shanghai, China; Shanghai Key Laboratory of Perioperative Stress and Protection, Shanghai, China.'}, {'ForeName': 'Mengdi', 'Initials': 'M', 'LastName': 'Qu', 'Affiliation': 'Department of Anaesthesiology, Zhongshan Hospital, Shanghai, China; Shanghai Key Laboratory of Perioperative Stress and Protection, Shanghai, China.'}, {'ForeName': 'Kefang', 'Initials': 'K', 'LastName': 'Guo', 'Affiliation': 'Department of Anaesthesiology, Zhongshan Hospital, Shanghai, China; Shanghai Key Laboratory of Perioperative Stress and Protection, Shanghai, China.'}, {'ForeName': 'Yanghanzhao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Zhongshan Hospital, Shanghai, China; Shanghai Key Laboratory of Perioperative Stress and Protection, Shanghai, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Anaesthesiology, Zhongshan Hospital, Shanghai, China; Shanghai Key Laboratory of Perioperative Stress and Protection, Shanghai, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anaesthesiology, Zhongshan Hospital, Shanghai, China; Shanghai Key Laboratory of Perioperative Stress and Protection, Shanghai, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Anaesthesiology, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Cata', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, University of Texas MD Anderson Cancer Centre, Houston, TX, USA; Anaesthesiology and Surgical Oncology Research Group, Houston, TX, USA. Electronic address: jcata@mdanderson.org.'}, {'ForeName': 'Wankun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Anaesthesiology, Zhongshan Hospital, Shanghai, China; Shanghai Key Laboratory of Perioperative Stress and Protection, Shanghai, China. Electronic address: chenwank@163.com.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Miao', 'Affiliation': 'Department of Anaesthesiology, Zhongshan Hospital, Shanghai, China; Shanghai Key Laboratory of Perioperative Stress and Protection, Shanghai, China. Electronic address: miaochangh@163.com.'}]",British journal of anaesthesia,['10.1016/j.bja.2022.03.031']
1791,35697491,Neuromuscular Training in Pre-Professional Ballet Dancers: A Feasibility Randomized Controlled Trial.,"INTRODUCTION


It is well documented that there is high prevalence of injuries in pre-professional and professional ballet dancers. Current evidence from high in quality and quantity research on injury prevention in sport indicates that interventions can reduce injury risks by 30% to 50%. Injury prevention research in dance is limited. The aim of this study was to assess the feasibility (adherence, fidelity, and practicality) of a randomized controlled trial for the utilization of neuromuscular training in pre-professional ballet dancers.
METHODS


A convenience sample of 22 pre-professional ballet dancers were randomized into an intervention and control group. The intervention group took part in a neuromuscular-based training workout, five times per week before the ballet class, for 10 weeks. The intervention was an adaptation of the FIFA 11+, an injury prevention intervention and is called 11+ Dance. The intervention consisted of low intensity bodyweight exercises that lasted 20 to 30 minutes performed daily.
RESULTS


Intervention adherence was 38% ± 8%, with higher participation at the beginning of the study. Attendance for post-testing was low 45% and 36% for the intervention and control group, respectively, mainly due to injury. There were no adverse effects reported, however, the participants reported delayed onset muscle soreness at the beginning of the intervention, indicating that there may be a potential training effect. Fear of muscle hypertrophy and fatigue were also reported as reasons for attrition. The repeated measures ANOVA revealed statistically non-significant differences for the countermovement jump F(1, 9) = 0.36, p = 0.564, 𝜂2p = 0.04; reactive strength index F(1, 7) = 0.02, p = 0.885, 𝜂2p = 0.003; and the isometric mid-thigh pull F(1, 12) = 0.002, p = 0.967, 𝜂2p = 0.000.
CONCLUSION


The results of the study, together with the feedback from the participants, suggest that some protocol modifications are necessary for the feasibility of a randomized controlled trial in a pre-professional setting. The current trial has produced valuable information for the intervention frequency and load prescription.",2022,"There were no adverse effects reported, however, the participants reported delayed onset muscle soreness at the beginning of the intervention, indicating that there may be a potential training effect.","['A convenience sample of 22 pre-professional ballet dancers', 'Pre-Professional Ballet Dancers']","['Neuromuscular Training', 'neuromuscular training', 'low intensity bodyweight exercises that lasted 20 to 30 minutes performed daily']","['feasibility (adherence, fidelity, and practicality', 'delayed onset muscle soreness', 'Fear of muscle hypertrophy and fatigue', 'injury risks']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0582456', 'cui_str': 'At risk for injury'}]",,0.0672338,"There were no adverse effects reported, however, the participants reported delayed onset muscle soreness at the beginning of the intervention, indicating that there may be a potential training effect.","[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Kolokythas', 'Affiliation': 'Elmhurst Ballet School, Birmingham, United Kingdom.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Metsios', 'Affiliation': 'Institute of Human Sciences, University of Wolverhampton, United Kingdom.'}, {'ForeName': 'Shaun M', 'Initials': 'SM', 'LastName': 'Galloway', 'Affiliation': 'Institute of Human Sciences, University of Wolverhampton, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Allen', 'Affiliation': 'National Institute of Dance Medicine and Science, Wolverhampton, United Kingdom.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Wyon', 'Affiliation': 'National Institute of Dance Medicine and Science, Wolverhampton, United Kingdom.'}]",Journal of dance medicine & science : official publication of the International Association for Dance Medicine & Science,['10.12678/1089-313X.091522e']
1792,35697435,Intolerance of Uncertainty and Perfectionistic Beliefs About Parenting as Cognitive Mechanisms of Symptom Change During Cognitive Behavior Therapy for Perinatal Anxiety.,"OBJECTIVE


A recent randomized controlled trial of group cognitive behavior therapy (CBGT) for perinatal anxiety showed that CBGT is effective in reducing anxiety and depression in pregnant and postpartum women. In secondary analyses, the role of potential mechanisms of symptom change was examined, including intolerance of uncertainty (IU), self-oriented parenting perfectionism (SOPP) and societal-prescribed parenting perfectionism (SPPP).
METHOD


The sample included 75 women (M age  = 31.99, SD = 3.57; 37.3% pregnant, 62.7% postpartum) who sought treatment for anxiety and completed the 6-week CBGT or 6-week waitlist within the larger trial. Measures of anxiety (State-Trait Inventory for Cognitive and Somatic Anxiety; STICSA), depression (Edinburgh Postnatal Depression Scale; EPDS), and the proposed mediators (IU, SOPP, SPPP) were completed at baseline and 6-weeks post-baseline.
RESULTS


Two moderated mediation models were evaluated to identify potential mediators of the effect of condition (CBGT, waitlist) on anxiety (STICSA; Model 1) or depressive symptoms (EPDS; Model 2). In Model 1, changes in IU partially mediated the effect of condition on anxiety (STICSA) for both pregnant and postpartum women. Changes in SOPP and SPPP were partial mediators for postpartum women only. Change in depression (EPDS) was also a partial mediator for pregnant women in this model. In Model 2, none of the cognitive variables mediated the effect of condition on depressive symptoms (EPDS). However, change in anxiety (STICSA) was a significant mediator of the effect of condition on depression (EPDS) and only among pregnant women.
CONCLUSIONS


The results provide support for IU, SOPP and SPPP as mechanisms of change during CBGT and identify differences in important mechanisms among pregnant and postpartum women.",2022,"However, change in anxiety (STICSA) was a significant mediator of the effect of condition on depression (EPDS) and only among pregnant women.
","['pregnant and postpartum women', '75 women (M age  = 31.99, SD = 3.57; 37.3% pregnant, 62.7% postpartum) who sought treatment for anxiety and completed the 6-week CBGT or 6-week waitlist within the larger trial']","['group cognitive behavior therapy (CBGT', 'CBGT', 'Cognitive Behavior Therapy']","['change in anxiety (STICSA', 'Change in depression (EPDS', 'anxiety (State-Trait Inventory for Cognitive and Somatic Anxiety; STICSA), depression (Edinburgh Postnatal Depression Scale; EPDS), and the proposed mediators (IU, SOPP, SPPP', 'depressive symptoms (EPDS', 'anxiety (STICSA', 'intolerance of uncertainty (IU), self-oriented parenting perfectionism (SOPP) and societal-prescribed parenting perfectionism (SPPP', 'anxiety and depression', 'depression (EPDS']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",75.0,0.0328894,"However, change in anxiety (STICSA) was a significant mediator of the effect of condition on depression (EPDS) and only among pregnant women.
","[{'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Donegan', 'Affiliation': ""Women's Health Concerns Clinic, St. Joseph's Healthcare, Hamilton & Department of Psychiatry and Behavioural Neurosciences, McMaster University.""}, {'ForeName': 'Benicio N', 'Initials': 'BN', 'LastName': 'Frey', 'Affiliation': ""Women's Health Concerns Clinic, St. Joseph's Healthcare, Hamilton & Department of Psychiatry and Behavioural Neurosciences; McMaster University; Mood Disorders Program, St. Joseph's Healthcare Hamilton.""}, {'ForeName': 'Randi E', 'Initials': 'RE', 'LastName': 'McCabe', 'Affiliation': ""McMaster University; Anxiety Treatment and Resarch Clinic, St. Joseph's Healthcare, Hamilton & Department of Psychiatry and Behavioural Neurosciences, McMaster University.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University.'}, {'ForeName': 'Sheryl M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': ""Women's Health Concerns Clinic, St. Joseph's Healthcare, Hamilton & Department of Psychiatry and Behavioural Neurosciences, McMaster University. Electronic address: sgreen@stjoes.ca.""}]",Behavior therapy,['10.1016/j.beth.2022.02.005']
1793,35697433,Feasibility and Acceptability of Group-Facilitated Prolonged Exposure Therapy for PTSD in VA Residential Rehabilitation Treatment Programs.,"Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder (PTSD); however, few VA patients receive this treatment. One of the barriers to PE receipt is that it is only available in an individual (one-on-one) format, whereas many VA mental health clinics provide the majority of their psychotherapy services in group format. In particular, PTSD residential rehabilitation treatment programs (RRTPs) offer most programming in group format. Consequently, strategies are needed to improve the scalability of PE by adapting it to fit the delivery setting. The current study was designed to pilot test a group-facilitated format of PE in RRTPs. Thirty-nine Veterans who were engaged in care in the PTSD RRTP at a Midwestern VA were recruited to participate in a Group-facilitated PE protocol. Participants engaged in twelve 90-minute sessions of Group PE over the course of 6 weeks, plus six 60-minute individual sessions for imaginal exposure. Group treatment followed the PE model and consisted of psychoeducation, treatment rationale, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms. PTSD symptoms were measured via the PTSD Checklist for DSM-5 (PCL-5) and depression symptoms were measured via the Patient Health Questionnaire (PHQ-9) at baseline, endpoint (6 weeks), and at 2-month follow-up. Thirty-nine individuals initiated Group-facilitated PE and 34 completed treatment. The average number of group sessions attended was 11 out of 12. Acceptability ratings were high. Mean change (improvement) in the intent-to-treat sample at 2-month follow-up was 20.0 points on the PCL-5 (CI 18.1, 21.9; Cohen's d = 1.1) and 4.8 points on the PHQ-9 (CI 4.1, 5.5, d = .8). These results suggest that adapted evidence-based interventions for PTSD can improve treatment access and efficiency for the RRTP setting. A group-based approach has the potential to improve the scalability of PTSD treatment by reducing required resources. A fully powered trial is now needed to test the effectiveness of Group-facilitated PE in the RRTP setting.",2022,Acceptability ratings were high.,"['Thirty-nine Veterans who were engaged in care in the PTSD RRTP at a Midwestern VA', 'Thirty-nine individuals initiated Group-facilitated PE and 34 completed treatment']","['Prolonged Exposure therapy (PE', 'Group-Facilitated Prolonged Exposure Therapy']","['PTSD Checklist for DSM-5 (PCL-5) and depression symptoms', 'Acceptability ratings', 'PTSD symptoms', 'Patient Health Questionnaire (PHQ-9']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",39.0,0.0419728,Acceptability ratings were high.,"[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Sripada', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, Ann Arbor; Veterans Affairs Ann Arbor Health Care System; University of Michigan. Electronic address: rekaufma@med.umich.edu.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Rodriguez', 'Affiliation': 'VA VISN 10 Clinical Resource Hub.'}, {'ForeName': 'Theodore P', 'Initials': 'TP', 'LastName': 'Wright', 'Affiliation': 'Battle Creek VA Medical Center.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Hyland', 'Affiliation': 'Battle Creek VA Medical Center.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Walters', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, Ann Arbor.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Ganoczy', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, Ann Arbor.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Haft', 'Affiliation': 'Bay Pines VA Healthcare System.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Smith', 'Affiliation': 'Veterans Affairs Ann Arbor Health Care System.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Porter', 'Affiliation': 'Veterans Affairs Ann Arbor Health Care System.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Driesenga', 'Affiliation': 'Battle Creek VA Medical Center.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'DeJong', 'Affiliation': 'Battle Creek VA Medical Center.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Emory University; Atlanta VA Medical Center.'}]",Behavior therapy,['10.1016/j.beth.2022.02.004']
1794,35697429,"A Pilot Randomized Clinical Trial of a Novel, Culturally Adapted, Trauma-Focused Cognitive-Behavioral Intervention for War-Related PTSD in Iraqi Women.","Trauma-focused cognitive-behavioral therapy (TF-CBT), broadly, is one of the leading evidence-based treatments for youth with posttraumatic stress disorder (PTSD). Generally, few culturally adapted TF-CBT interventions have been examined among war trauma-affected populations in low- and middle-income countries. Using a randomized clinical trial design, a total of 48 war trauma-exposed women in Iraq, M age  (SD) = 32.91 (5.33), with PTSD were randomly assigned to either TF-CBT or wait-list control (WLC) conditions. The intervention group received 12 individual weekly sessions of a culturally adapted TF-CBT intervention. Significant reductions in PTSD symptom severity were reported by women in the TF-CBT condition from pre- to posttreatment. Women in the TF-CBT condition reported significantly greater reductions in PTSD symptoms compared to WLC at 1-month follow-up. Additionally, levels of depression, anxiety, stress, and use of maladaptive emotion regulation strategies were significantly lower in the TF-CBT condition at posttreatment and 1-month follow-up, compared to the WLC condition. Women in the TF-CBT condition also reported significant improvements in various domains of quality of life at posttreatment and 1-month follow-up. This clinical trial provides preliminary cross-cultural support for the feasibility and efficacy of TF-CBT for the treatment of PTSD symptoms among women in non-Western cultures. Future directions and study limitations are discussed.",2022,Women in the TF-CBT condition reported significantly greater reductions in PTSD symptoms compared to WLC at 1-month follow-up.,"['women in non-Western cultures', '48 war trauma-exposed women in Iraq, M age  (SD)\u202f=\u202f32.91 (5.33), with PTSD', 'War-Related PTSD in Iraqi Women', 'youth with posttraumatic stress disorder (PTSD']","['Trauma-focused cognitive-behavioral therapy (TF-CBT', 'TF-CBT', '12 individual weekly sessions of a culturally adapted TF-CBT intervention', 'TF-CBT or wait-list control (WLC) conditions', 'Culturally Adapted, Trauma-Focused Cognitive-Behavioral Intervention']","['PTSD symptom severity', 'various domains of quality of life', 'levels of depression, anxiety, stress, and use of maladaptive emotion regulation strategies', 'PTSD symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517791', 'cui_str': '5.33'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1556087', 'cui_str': 'Iraqi'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",48.0,0.0266009,Women in the TF-CBT condition reported significantly greater reductions in PTSD symptoms compared to WLC at 1-month follow-up.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Zemestani', 'Affiliation': 'University of Kurdistan. Electronic address: m.zemestani@uok.ac.ir.'}, {'ForeName': 'Ako Faiq', 'Initials': 'AF', 'LastName': 'Mohammed', 'Affiliation': 'University of Kurdistan and Jiyan Foundation for Human Rights.'}, {'ForeName': 'Azad Ali', 'Initials': 'AA', 'LastName': 'Ismail', 'Affiliation': 'Koya University.'}, {'ForeName': 'Anka A', 'Initials': 'AA', 'LastName': 'Vujanovic', 'Affiliation': 'University of Houston.'}]",Behavior therapy,['10.1016/j.beth.2022.01.009']
1795,35697428,Using Technology to Promote Therapist Use of Exposure Therapy for Childhood Anxiety Disorders: A Randomized Pilot Study.,"Increasing the use of exposure by community therapists during the treatment of childhood anxiety disorders is critical to improving the quality of available treatment. The aim of the current study was to investigate whether a brief training in the delivery of an exposure-focused and technology-assisted treatment protocol increased community therapist openness to exposure therapy, use of exposure in treatment, and improvement in patient symptoms. Participants were 17 therapists recruited from a large health system to provide outpatient therapy to 32 youth ages 8-18 (M = 12.13, 78.1% girls) with treatment as usual or with the Anxiety Coach application (AC-app). Consistent with two of three hypotheses, therapists in the AC-app condition increased their openness to, and use of, exposure-however, these changes did not translate into improved therapeutic outcomes. Comparisons to benchmark studies suggest that the community therapists did not implement enough in vivo exposure of sufficient intensity or include parents enough to improve outcome. Results support the ability of exposure-focused treatment protocols to increase community therapists' use of evidence-based treatment and suggest that future efforts should focus on improving the quality, in addition to quantity, of therapist-delivered exposure.",2022,"Consistent with two of three hypotheses, therapists in the AC-app condition increased their openness to, and use of, exposure-however, these changes did not translate into improved therapeutic outcomes.","['Childhood Anxiety Disorders', 'patient symptoms', 'childhood anxiety disorders', 'Participants were 17 therapists recruited from a large health system to provide outpatient therapy to 32 youth ages 8-18 (M\u202f=\u202f12.13, 78.1% girls) with treatment as usual or with the Anxiety Coach application (AC-app']",['Exposure Therapy'],[],"[{'cui': 'C0270302', 'cui_str': 'Anxiety disorder of childhood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]",[],17.0,0.0197429,"Consistent with two of three hypotheses, therapists in the AC-app condition increased their openness to, and use of, exposure-however, these changes did not translate into improved therapeutic outcomes.","[{'ForeName': 'Stephen P H', 'Initials': 'SPH', 'LastName': 'Whiteside', 'Affiliation': 'Mayo Clinic. Electronic address: whiteside.stephen@mayo.edu.'}, {'ForeName': 'Bridget K', 'Initials': 'BK', 'LastName': 'Biggs', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Dammann', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Tiede', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Deanna R', 'Initials': 'DR', 'LastName': 'Hofschulte', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Reneson-Feeder', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Cunningham', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Sawchuk', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Geske', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Elle', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Mayo Clinic.'}]",Behavior therapy,['10.1016/j.beth.2022.01.010']
1796,35697427,Emotion Regulation as a Moderator of Outcomes of Transdiagnostic Group Cognitive-Behavioral Therapy for Emotional Disorders.,"The aim of this study was to examine the potential moderating effect of baseline emotion regulation skills-cognitive reappraisal and expressive suppression-on the relationship between treatment allocation and treatment outcomes in primary care patients with emotional symptoms. A total of 631 participants completed scales to evaluate emotion regulation, anxiety, depression, functioning, and quality of life (QOL). The moderation analysis was carried out using the SPSS PROCESS macro, version 3.5. Expressive suppression was a significant moderator in the relationship between treatment allocation and treatment outcomes in terms of symptoms of anxiety (b = -0.530, p = .026), depression (b = -0.812, p = .004), and QOL (b = 0.156, p = .048). Cognitive reappraisal acted as a moderator only in terms of QOL (b = 0.217, p = .028). The findings of this study show that participants with higher scores of expressive suppression benefited more from the addition of transdiagnostic cognitive-behavioral therapy to treatment as usual (TAU) in terms of anxiety and depressive symptoms, and QOL. Individuals with higher levels of cognitive reappraisal obtained a greater benefit in terms of QOL from the addition of psychological treatment to TAU. These results underscore the relevant role that emotion regulation skills play in the outcomes of psychological therapy for emotional symptoms.",2022,Individuals with higher levels of cognitive reappraisal obtained a greater benefit in terms of QOL from the addition of psychological treatment to TAU.,"['Emotional Disorders', '631 participants completed', 'primary care patients with emotional symptoms']","['Transdiagnostic Group Cognitive-Behavioral Therapy', 'baseline emotion regulation skills-cognitive reappraisal and expressive suppression']","['scales to evaluate emotion regulation, anxiety, depression, functioning, and quality of life (QOL', 'Expressive suppression', 'QOL', 'depression', 'symptoms of anxiety']","[{'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",631.0,0.0536209,Individuals with higher levels of cognitive reappraisal obtained a greater benefit in terms of QOL from the addition of psychological treatment to TAU.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Barrio-Martínez', 'Affiliation': 'Complutense University of Madrid and Valdecilla Biomedical Research Institute.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'González-Blanch', 'Affiliation': 'Marqués de Valdecilla University Hospital and Universidad Europea del Atlántico. Electronic address: cesar.gonzalezblanch@scsalud.es.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'Priede', 'Affiliation': 'Valdecilla Biomedical Research Institute, Hospital de Laredo.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Muñoz-Navarro', 'Affiliation': 'University of Valencia.'}, {'ForeName': 'Leonardo Adrián', 'Initials': 'LA', 'LastName': 'Medrano', 'Affiliation': 'Pontificia Universidad Católica Madre y Maestra.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Moriana', 'Affiliation': 'Universidad de Córdoba and Maimónides Institute for Research in Biomedicine of Cordoba.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Carpallo-González', 'Affiliation': 'Complutense University of Madrid.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': 'Ventura', 'Affiliation': 'Valdecilla Biomedical Research Institute.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Ruiz-Rodríguez', 'Affiliation': 'Castilla La Nueva Primary Care Centre, Health Service of Madrid.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cano-Vindel', 'Affiliation': 'Complutense University of Madrid.'}]",Behavior therapy,['10.1016/j.beth.2022.01.007']
1797,35697426,An Open Trial Examining Dialectical Behavior Therapy Skills and Behavioral Weight Loss for Adults With Emotional Eating and Overweight/Obesity.,"Third-wave cognitive behavioral interventions for weight loss have shown promise. However, sparse data exists on the use of dialectical behavior therapy for weight loss. Adapted dialectical behavior therapy skills programs may be especially well suited for adults who engage in emotional eating and are seeking weight loss. Dialectical behavior therapy is skills-based, shares theoretical links to emotional eating, and is effective in treating binge eating. The current study examined the feasibility, acceptability, and preliminary efficacy of Live FREE: FReedom from Emotional Eating, a 16-session group-based intervention. A total of 87 individuals expressed interest in the program, and 39 adults with overweight/obesity (BMI ≥25) and elevated self-reported emotional eating were enrolled. Live FREE targeted emotional eating in the initial sessions 1-9, and sessions 10-16 focused primarily on behavioral weight loss skills while continuing to reinforce emotion regulation training. Assessments were administered at baseline, posttreatment, and 6-month follow up. Enrolled participants were primarily female (97.4%) and Caucasian (91.7%). Treatment retention was strong with participants attending an average of 14.3 sessions and 89.7% of participants completing the intervention. On average, participants lost 3.00 kg at posttreatment, which was maintained at follow-up. Intent-to-treat analyses showed improvements in key outcome variables (self-reported emotional eating, BMI, emotion regulation) over the course of the intervention. Combining dialectical behavior therapy skills with conventional behavioral weight loss techniques may be an effective intervention for adults with overweight/obesity who report elevated emotional eating.",2022,"Intent-to-treat analyses showed improvements in key outcome variables (self-reported emotional eating, BMI, emotion regulation) over the course of the intervention.","['Adults With Emotional Eating and Overweight/Obesity', 'Enrolled participants were primarily female (97.4%) and Caucasian (91.7', 'adults with overweight/obesity who report elevated emotional eating', '87 individuals expressed interest in the program, and 39 adults with overweight/obesity (BMI ≥25) and elevated self-reported emotional eating were enrolled', 'adults who engage in emotional eating and are seeking weight loss']","['Dialectical behavior therapy', 'Live FREE', 'dialectical behavior therapy']","['emotional eating, BMI, emotion regulation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",87.0,0.0391786,"Intent-to-treat analyses showed improvements in key outcome variables (self-reported emotional eating, BMI, emotion regulation) over the course of the intervention.","[{'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Braden', 'Affiliation': 'Bowling Green State University. Electronic address: abbym@bgsu.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Redondo', 'Affiliation': 'Bowling Green State University.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Ferrell', 'Affiliation': 'Bowling Green State University.'}, {'ForeName': 'LaNaya', 'Initials': 'L', 'LastName': 'Anderson', 'Affiliation': 'Bowling Green State University.'}, {'ForeName': 'Jennifer Grant', 'Initials': 'JG', 'LastName': 'Weinandy', 'Affiliation': 'Bowling Green State University.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Watford', 'Affiliation': 'Bowling Green State University.'}, {'ForeName': 'Wesley R', 'Initials': 'WR', 'LastName': 'Barnhart', 'Affiliation': 'Bowling Green State University.'}]",Behavior therapy,['10.1016/j.beth.2022.01.008']
1798,35697424,Outcomes From the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for Midlife and Older Adults With Serious Mental Illness and Sleep and Circadian Dysfunction.,"The present study tested outcomes of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) among midlife and older adults with serious mental illness (SMI). Further, we tested predictors-credibility, expectancy, usefulness, and utilization-that may affect TranS-C outcomes. Midlife and older participants from a community setting (>49 years, 62.3% female, 37.7% African American or Black) with sleep and circadian problems and SMI were randomized to receive TranS-C plus usual care (TranS-C+UC, n = 27) or usual care followed by delayed treatment with TranS-C (UC-DT, n = 26). Immediate and delayed TranS-C data were combined to increase power (combined n = 52). Outcomes were assessed at pretreatment, posttreatment, and 6-month follow-up. Credibility and expectancy were assessed during the second session. Usefulness and utilization of TranS-C skills were assessed at posttreatment and 6-month follow-up. TranS-C+UC, relative to UC-DT, was associated with improvements in depression symptoms, sleep disturbance, overall sleep health, and select sleep/wake outcomes, though not all improvements were sustained at 6-month follow-up. Lower usefulness of TranS-C skills predicted more severe sleep disturbance at posttreatment and daytime sleep-related impairment at posttreatment and 6-month follow-up. Lower utilization predicted more severe psychiatric symptoms at posttreatment, sleep disturbance at posttreatment and 6-month follow-up, and overall impairment and daytime sleep-related impairment at 6-month follow-up. Higher credibility and expectancy predicted greater usefulness of TranS-C skills at posttreatment and 6-month follow-up and greater utilization at 6-month follow-up. Together, findings highlight benefits of TranS-C for midlife and older adults with SMI. However, boosting credibility, expectancy, utilization, and usefulness may meaningfully improve TranS-C outcomes.",2022,Higher credibility and expectancy predicted greater usefulness of TranS-C skills at posttreatment and 6-month follow-up and greater utilization at 6-month follow-up.,"['Midlife and older participants from a community setting (>49 years, 62.3% female, 37.7% African American or Black) with sleep and circadian problems and SMI', 'Midlife and Older Adults With Serious Mental Illness and Sleep and Circadian Dysfunction', 'midlife and older adults with SMI', 'midlife and older adults with serious mental illness (SMI']","['TranS-C plus usual care (TranS-C+UC, n = 27) or usual care followed by delayed treatment with TranS-C', 'TranS-C skills', 'Transdiagnostic Sleep and Circadian Intervention (TranS-C', 'TranS-C']","['severe sleep disturbance', 'boosting credibility, expectancy, utilization', 'overall impairment and daytime sleep-related impairment', 'Usefulness and utilization of TranS-C skills', 'Credibility and expectancy', 'sleep disturbance', 'severe psychiatric symptoms', 'predictors-credibility, expectancy, usefulness, and utilization-that may affect TranS-C outcomes', 'TranS-C skills', 'depression symptoms, sleep disturbance, overall sleep health, and select sleep/wake outcomes']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3693346', 'cui_str': 'Treatment Delay'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442696', 'cui_str': 'Waking'}]",52.0,0.0568407,Higher credibility and expectancy predicted greater usefulness of TranS-C skills at posttreatment and 6-month follow-up and greater utilization at 6-month follow-up.,"[{'ForeName': 'Laurel D', 'Initials': 'LD', 'LastName': 'Sarfan', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': 'Gasperetti', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley. Electronic address: aharvey@berkeley.edu.'}]",Behavior therapy,['10.1016/j.beth.2022.02.001']
1799,35697792,Experimental evidence on learning using low-tech when school is out.,"School closures occurred extensively during the COVID-19 pandemic, and occur in other settings, such as teacher strikes and natural disasters. The cost of school closures has proven to be substantial, particularly for households of lower socioeconomic status, but little evidence exists on how to mitigate these learning losses. This paper provides experimental evidence on strategies to support learning when schools close. We conduct a large-scale randomized trial testing two low-technology interventions-SMS messages and phone calls-with parents to support their child in Botswana. The combined treatment improves learning by 0.12 standard deviations, which translates to 0.89 standard deviations of learning per US$100, ranking among the most cost-effective interventions to improve learning. We develop remote assessment innovations, which show robust learning outcomes. Our findings have immediate policy relevance and long-run implications for the role of technology and parents to support education provision during school disruptions.",2022,We conduct a large-scale randomized trial testing two low-technology interventions-SMS messages and phone calls-with parents to support their child in Botswana.,[],['low-technology interventions-SMS messages and phone calls-with parents to support their child in Botswana'],[],[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}]",[],2.0,0.0688277,We conduct a large-scale randomized trial testing two low-technology interventions-SMS messages and phone calls-with parents to support their child in Botswana.,"[{'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Angrist', 'Affiliation': 'Youth Impact, Gaborone, Botswana. nangrist@youth-impact.org.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bergman', 'Affiliation': 'Teachers College, Columbia University, NY, USA.'}, {'ForeName': 'Moitshepi', 'Initials': 'M', 'LastName': 'Matsheng', 'Affiliation': 'Youth Impact, Gaborone, Botswana.'}]",Nature human behaviour,['10.1038/s41562-022-01381-z']
1800,35698124,Exploring patient experiences and acceptability of group vs. individual acupuncture for Cancer-related pain: a qualitative study.,"BACKGROUND


Individual acupuncture (AP) is a safe and effective treatment for cancer-related pain and other symptoms in cancer survivors. However, access to individual AP is limited, and costs can be prohibitive. Group AP could be a more cost-effective alternative as it is less expensive and non-inferior to individual AP for pain relief. Despite growing evidence in favour of group AP, patient acceptability and experience of group AP in cancer patients is relatively unknown. This exploratory study sought to compare patient experiences and acceptability of group versus individual AP in cancer patients.
METHODS


Semi-structured, open-ended, in-depth interviews were conducted in a subset of 11 cancer patients enrolled in a randomized non-inferiority trial of group vs. individual AP for cancer pain. Participants for this study were recruited via purposive sampling, aiming for diversity in age, sex, education, employment, cancer types, and treatment arms. Data was analyzed using inductive thematic analysis.
RESULTS


Two major themes were identified: a) overall experience of AP treatment b) value of AP. Participants across both treatment arms acknowledged improvement in pain, quality of sleep, mood and fatigue. Participants in the group AP arm reported a significant increase in perceived social support, while participants in the individual arm valued privacy and one-on-one interaction with the acupuncturist. Although some participants in the group arm had privacy-related concerns before the commencement of the program, these concerns waned after a few AP sessions. Participants across both the treatment arms reported cordial clinician-patient relationship with the acupuncturist. Willingness to pursue AP treatment in the future was comparable across both the treatment arms and was limited by out-of-pocket costs.
CONCLUSION


Patient acceptability and experience of treatment in group AP was on par with individual AP. Group AP may further augment perceived social support among patients and privacy concerns, if any, subside after a few sessions.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT03641222 ). Registered 10 July 2018 - Retrospectively registered.",2022,"Participants in the group AP arm reported a significant increase in perceived social support, while participants in the individual arm valued privacy and one-on-one interaction with the acupuncturist.","['cancer patients', 'Semi-structured, open-ended, in-depth interviews were conducted in a subset of 11 cancer patients enrolled in a randomized non-inferiority trial of group vs. individual AP for cancer pain', 'Cancer-related pain', 'Registered 10 July 2018 - Retrospectively registered']","['individual acupuncture', 'acupuncture (AP']","['overall experience of AP treatment b) value of AP', 'pain, quality of sleep, mood and fatigue', 'perceived social support']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",,0.170943,"Participants in the group AP arm reported a significant increase in perceived social support, while participants in the individual arm valued privacy and one-on-one interaction with the acupuncturist.","[{'ForeName': 'Devesh', 'Initials': 'D', 'LastName': 'Oberoi', 'Affiliation': 'Division of Psychosocial Oncology, Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Reed', 'Affiliation': 'Division of Psychosocial Oncology, Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Katherine-Ann', 'Initials': 'KA', 'LastName': 'Piedalue', 'Affiliation': 'Division of Psychosocial Oncology, Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Jessa', 'Initials': 'J', 'LastName': 'Landmann', 'Affiliation': 'Vive Integrative Health Group, 1889 - 45 Street NW, Calgary, AB, Canada.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Division of Psychosocial Oncology, Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. lcarlso@ucalgary.ca.'}]",BMC complementary medicine and therapies,['10.1186/s12906-022-03600-6']
1801,35698101,Influence on study outcomes of an inpatient study by the behavior of the study staff (PINgPOng): study protocol for a randomized clinical trial.,"BACKGROUND


The placebo effect as the symptom improvement following inert treatments is a fixed component of RCTs to differentiate between specific effects of the tested pharmacological substance from other unspecific effects. The PINgPOng study was set up to analyze the influence of a study team trained to either minimize the placebo response and optimize drug-placebo differences or to maximize the placebo response to increase drug efficacy by unspecific factors on the study results of a RCT in a classical early clinical trial setting.
METHODS/DESIGN


PINgPOng is a single-center, prospective, randomized, double-blind, placebo-controlled study in a 3-group, 2-sequence, 2-period cross-over design. The study is conducted according to the principles of ICH-GCP and the Declaration of Helsinki on the Phase I-Unit of the University Hospital Bonn. The primary endpoint is the pain intensity in the cold pressor test before and after the administration of 15 mg oxycodone or placebo. The pain intensity is compared between three study conditions: 32 healthy volunteers in each study arm will be treated either by an untrained study team (arm A), by a study team trained to maximize (arm B), or to minimize placebo responses (arm C). Neuroendocrine factors (alpha-amylase activity, salivary cortisol), characteristic traits (anxiety, depression, stress), and somatic reactions are analyzed as covariates of the pain perception.
DISCUSSION


The PINgPOng study will allow to answer the question whether and to what extent the behavior of a trained study team (neutral vs. maximize vs. minimize placebo responses) will differentially affect placebo responses in a setting of a highly standardized early clinical trial. The results will help to control the placebo effects by education of the clinical study team and to avoid unnecessary high placebo effects in clinical development.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00013586 . Registered on December 22, 2017.",2022,The primary endpoint is the pain intensity in the cold pressor test before and after the administration of 15 mg oxycodone or placebo.,['32 healthy volunteers'],"['placebo', 'oxycodone']","['pain intensity in the cold pressor test', 'pain intensity', 'Neuroendocrine factors (alpha-amylase activity, salivary cortisol), characteristic traits (anxiety, depression, stress), and somatic reactions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",32.0,0.288933,The primary endpoint is the pain intensity in the cold pressor test before and after the administration of 15 mg oxycodone or placebo.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Coenen', 'Affiliation': 'Clinical Study Core Unit, Study Center Bonn (SZB), University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany. martin.coenen@ukbonn.de.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Department of Neurology, University Hospital Essen, Hufelandstraße 55, 45147, Essen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Zunhammer', 'Affiliation': 'Department of Neurology, University Hospital Essen, Hufelandstraße 55, 45147, Essen, Germany.'}, {'ForeName': 'Maria Soledad', 'Initials': 'MS', 'LastName': 'Berdaguer', 'Affiliation': 'Clinical Study Core Unit, Study Center Bonn (SZB), University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fuhrmann', 'Affiliation': 'Clinical Study Core Unit, Study Center Bonn (SZB), University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute of Medical Biometrics, Informatics and Epidemiology, University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Rengelshausen', 'Affiliation': 'Clinical Science, Grünenthal GmbH, Zieglerstr. 6, 52078, Aachen, Germany.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Hartmann', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstraße 55, 45147, Essen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Coch', 'Affiliation': 'Clinical Study Core Unit, Study Center Bonn (SZB), University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany.'}]",Trials,['10.1186/s13063-022-06436-0']
1802,35698099,Communication Bridge™-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia.,"BACKGROUND


Primary progressive aphasia (PPA) is a clinical dementia syndrome. Impairments in language (speaking, reading, writing, and understanding) are the primary and persistent symptoms. These impairments progress insidiously and devastate communication confidence, participation, and quality of life for persons living with PPA. Currently, there are no effective disease modifying treatments for PPA. Speech-language interventions hold promise for mitigating communication challenges and language symptoms. However, evidence regarding their efficacy in PPA is of low quality and there are currently no rigorous randomized trials.
METHOD


Communication Bridge™-2 (CB2) is a Stage 2, superiority, single-blind, randomized, parallel group, active-control, behavioral clinical trial delivered virtually within a telehealth service delivery model to individuals with PPA. Ninety carefully characterized participants with clinically confirmed PPA will be randomized to one of two speech-language intervention arms: (1) Communication Bridge™ a dyadic intervention based in communication participation therapy models that incorporates salient training stimuli or (2) the control intervention a non-dyadic intervention based in impairment therapy models addressing word retrieval and language production that incorporates fixed stimuli. The superiority of Communication Bridge™ over the Control arm will be evaluated using primary outcomes of communication confidence and participation. Other outcomes include accuracy for trained words and scripts. Participants complete two therapy blocks over a 12-month period. Outcomes will be measured at baseline, at each therapy block, and at 12 months post enrollment.
DISCUSSION


The CB2 trial will supply Level 2 evidence regarding the efficacy of the Communication Bridge™ intervention delivered in a telehealth service delivery model for individuals with mild to moderate PPA. An important by-product of the CB2 trial is that these data can be used to evaluate the efficacy of speech-language interventions delivered in both trial arms for persons with PPA. The impact of these data should not be overlooked as they will yield important insights examining why interventions work and for whom, which will advance effectiveness trials for speech-language interventions in PPA.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03371706 . Registered prospectively on December 13, 2017.",2022,The CB2 trial will supply Level 2 evidence regarding the efficacy of the Communication Bridge™ intervention delivered in a telehealth service delivery model for individuals with mild to moderate PPA.,"['individuals with mild to moderate PPA', 'Communication Bridge™-2', 'persons with PPA', 'individuals with PPA', 'persons living with PPA', 'individuals with mild to moderate primary progressive aphasia', 'Ninety carefully characterized participants with clinically confirmed PPA']","['speech-language intervention arms: (1) Communication Bridge™ a dyadic intervention based in communication participation therapy models that incorporates salient training stimuli or (2) the control intervention a non-dyadic intervention based in impairment therapy models addressing word retrieval and language production that incorporates fixed stimuli', 'speech-language intervention', 'Communication Bridge™-2 (CB2']","['Impairments in language (speaking, reading, writing, and understanding', 'devastate communication confidence, participation, and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0338457', 'cui_str': 'Progressive aphasia'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0282513', 'cui_str': 'Primary progressive apraxia of speech'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",90.0,0.12798,The CB2 trial will supply Level 2 evidence regarding the efficacy of the Communication Bridge™ intervention delivered in a telehealth service delivery model for individuals with mild to moderate PPA.,"[{'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Roberts', 'Affiliation': 'Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, USA. angela.roberts@uwo.ca.'}, {'ForeName': 'Alfred W', 'Initials': 'AW', 'LastName': 'Rademaker', 'Affiliation': ""Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University, Chicago, USA.""}, {'ForeName': 'Elizabeth Ann', 'Initials': 'EA', 'LastName': 'Salley', 'Affiliation': ""Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University, Chicago, USA.""}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mooney', 'Affiliation': 'Oregon Health & Science University, Portland, USA.'}, {'ForeName': 'Darby', 'Initials': 'D', 'LastName': 'Morhardt', 'Affiliation': ""Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University, Chicago, USA.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fried-Oken', 'Affiliation': ""Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University, Chicago, USA.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weintraub', 'Affiliation': ""Mesulam Center for Alzheimer's Disease and Cognitive Neurology and Department of Psychiatry and Behavioral Sciences, Northwestern University, Chicago, USA.""}, {'ForeName': 'Marsel', 'Initials': 'M', 'LastName': 'Mesulam', 'Affiliation': ""Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University, Chicago, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Rogalski', 'Affiliation': ""Mesulam Center for Alzheimer's Disease and Cognitive Neurology and Department of Psychiatry and Behavioral Sciences, Northwestern University, Chicago, USA.""}]",Trials,['10.1186/s13063-022-06162-7']
1803,35698100,"Effects of pre-operative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy: protocol for a multicenter randomized controlled trial (point trial, pre-operative immunonutrition therapy).","BACKGROUND


Neoadjuvant chemoradiation followed by esophagectomy has been established as the first-line treatment for locally advanced esophageal cancer. Postoperative enteral nutrition has been widely used to improve perioperative outcomes. However, whether to implement preoperative nutritional intervention during neoadjuvant therapy is yet to be verified by prospective studies.
METHODS


POINT trial is a multicenter, open-labeled, randomized controlled trial. A total of 244 patients with surgically resectable esophageal cancer are randomly assigned to nutritional therapy group (arm A) or control group (arm B) with a 2:1 ratio. Both groups receive neoadjuvant chemotherapy with concurrent radiotherapy based on the CROSS regimen followed by minimally invasive esophagectomy. The primary endpoint is the rate of nutrition and immune-related complications after surgery. Secondary endpoints include completion rate of neoadjuvant chemoradiation and related adverse events, rate of pathological complete response, perioperative outcomes, nutritional status, overall survival, progression-free survival and quality of life.
DISCUSSION


This trial aims to verify whether immunonutrition during neoadjuvant chemoradiation can reduce the rate of complications and improve perioperative outcomes. Frequent communication and monitoring are essential for a multicenter investigator-initiated trial.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04513418. The trial was prospectively registered on 14 August 2020, https://www.
CLINICALTRIALS


gov/ct2/show/NCT04513418 .",2022,This trial aims to verify whether immunonutrition during neoadjuvant chemoradiation can reduce the rate of complications and improve perioperative outcomes.,"['locally advanced esophageal cancer', '244 patients with surgically resectable esophageal cancer', 'esophageal cancer patients treated with']","['nutritional therapy', 'neoadjuvant chemotherapy with concurrent radiotherapy based on the CROSS regimen followed by minimally invasive esophagectomy', 'neoadjuvant chemoradiotherapy', 'pre-operative enteral immunonutrition']","['rate of complications and improve perioperative outcomes', 'rate of nutrition and immune-related complications', 'completion rate of neoadjuvant chemoradiation and related adverse events, rate of pathological complete response, perioperative outcomes, nutritional status, overall survival, progression-free survival and quality of life']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",244.0,0.242089,This trial aims to verify whether immunonutrition during neoadjuvant chemoradiation can reduce the rate of complications and improve perioperative outcomes.,"[{'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.'}, {'ForeName': 'Dingpei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Clinical Nutrition, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Shengguang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiotherapy, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Qianwen', 'Initials': 'Q', 'LastName': 'Jin', 'Affiliation': 'Department of Clinical Nutrition, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Research Center, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Chengqiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Department of Thoracic Surgery, the Affiliated Lihuili Hospital, Ningbo University, Ningbo, 315048, China.'}, {'ForeName': 'Jinxian', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery, the Affiliated Lihuili Hospital, Ningbo University, Ningbo, 315048, China.'}, {'ForeName': 'Mingsong', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, China.""}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': ""Department of Thoracic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China.'}, {'ForeName': 'Qixun', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Oncological Surgery, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Weitian', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Thoracic Oncological Surgery, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, 350001, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, 350001, China.'}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200120, China.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Hecheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, China. lihecheng2000@hotmail.com.'}]",BMC cancer,['10.1186/s12885-022-09721-y']
1804,34954864,Immune microenvironment in patients with mismatch-repair-proficient oligometastatic colorectal cancer exposed to chemotherapy: the randomized MIROX GERCOR cohort study.,"In the era of immune checkpoint inhibitors, understanding the metastatic microenvironment of proficient mismatch repair/microsatellite stable (pMMR/MSS) colorectal cancer (CRC) is of paramount importance to both prognostication and the development of more effective novel therapies. In this study, primary and paired metastasis tissue samples were collected from patients with resectable metastatic CRC treated with adjuvant FOLFOX or peri-operative chemotherapy in the MIROX phase III prospective study. In total, 74 cancer tissues were stained for CD3, CD8, Forkhead box protein 3 (FOXP3), programmed cell death protein-1 (PD-1, invasive front, stromal, intra-epithelial compartments), and programmed death-ligand 1 (PD-L1, tumor, immune cells). The immune profiling of primary CRC had a limited value to predict the immune context of paired metastases for all markers but CD3+. The expression of CD8 and PD-L1 was higher in metastases after neoadjuvant FOLFOX. In metastases, both CD3 T cells at the invasive front and PD-L1 expressions on immune cells were predictive of better disease-free survival. These results show that the effect of FOLFOX on modifying the immune microenvironment in resected CRC metastases and measurement of PD-L1 expression and tumor-infiltrating CD8 T cells in pMMR/MSS metastatic tissue samples could improve treatment strategies of metastatic CRC patients.",2022,"In metastases, both CD3 T cells at the invasive front and PD-L1 expressions on immune cells were predictive of better disease-free survival.","['patients with mismatch-repair-proficient oligometastatic colorectal cancer', 'patients with resectable metastatic CRC treated with', 'metastatic CRC patients']","['adjuvant FOLFOX or peri-operative chemotherapy', 'FOLFOX', 'chemotherapy']","['expression of CD8 and PD-L1', 'CD3, CD8, Forkhead box protein 3 (FOXP3), programmed cell death protein-1 (PD-1, invasive front, stromal, intra-epithelial compartments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1155661', 'cui_str': 'DNA mismatch repair'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0118111', 'cui_str': 'Forkhead Proteins'}, {'cui': 'C0135710', 'cui_str': 'PDCD1 protein, human'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",74.0,0.0944564,"In metastases, both CD3 T cells at the invasive front and PD-L1 expressions on immune cells were predictive of better disease-free survival.","[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Jary', 'Affiliation': 'Multidisciplinary Group in Oncology (GERCOR), Paris, France.'}, {'ForeName': 'Wen-Wei', 'Initials': 'WW', 'LastName': 'Liu', 'Affiliation': 'Ventana Medical Systems Inc., Tucson, AZ, USA.'}, {'ForeName': 'Dongyao', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Ventana Medical Systems Inc., Tucson, AZ, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Bai', 'Affiliation': 'Ventana Medical Systems Inc., Tucson, AZ, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Muranyi', 'Affiliation': 'Ventana Medical Systems Inc., Tucson, AZ, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Colle', 'Affiliation': 'Department of Medical Oncology, University Hospital of Beaujon, Clichy, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Brocheriou', 'Affiliation': 'Department of Pathology, Assistance Publique-Hôpitaux de Paris, Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turpin', 'Affiliation': 'Multidisciplinary Group in Oncology (GERCOR), Paris, France.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Radosevic-Robin', 'Affiliation': 'Department of Pathology, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bourgoin', 'Affiliation': 'Department of Pathology, Assistance Publique-Hôpitaux de Paris, Saint-Antoine Hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Penault-Llorca', 'Affiliation': 'Department of Pathology, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Multidisciplinary Group in Oncology (GERCOR), Paris, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Multidisciplinary Group in Oncology (GERCOR), Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Multidisciplinary Group in Oncology (GERCOR), Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Multidisciplinary Group in Oncology (GERCOR), Paris, France.'}, {'ForeName': 'Kandavel', 'Initials': 'K', 'LastName': 'Shanmugam', 'Affiliation': 'Ventana Medical Systems Inc., Tucson, AZ, USA.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Svrcek', 'Affiliation': 'Multidisciplinary Group in Oncology (GERCOR), Paris, France.'}]",Molecular oncology,['10.1002/1878-0261.13173']
1805,35476124,Prevalence and patient-rated relevance of complexity factors in medication regimens of community-dwelling patients with polypharmacy.,"PURPOSE


To describe the prevalence of complexity factors in the medication regimens of community-dwelling patients with more than five drugs and to evaluate the relevance of these factors for individual patients.
METHODS


Data were derived from the HIOPP-6 trial, a controlled study conducted in 9 general practices which evaluated an electronic tool to detect and reduce complexity of drug treatment. The prevalence of complexity factors was based on the results of the automated analysis of 139 patients' medication data. The relevance assessment was based on the patients' rating of each factor in an interview (48 patients included for analysis).
RESULTS


A median of 5 (range 0-21) complexity factors per medication regimen were detected and at least one factor was observed in 131 of 139 patients. Almost half of these patients found no complexity factor in their medication regimen relevant.
CONCLUSION


In most medication regimens, complexity factors could be identified automatically, yet less than 15% of factors were indeed relevant for patients as judged by themselves. When assessing complexity of medication regimens, one should especially consider factors that are both particularly frequent and often challenging for patients, such as use of inhalers or tablet splitting.
TRIAL REGISTRATION


The HIOPP-6 trial was registered retrospectively on May 17, 2021, in the German Clinical Trials register under DRKS-ID DRKS00025257.",2022,"In most medication regimens, complexity factors could be identified automatically, yet less than 15% of factors were indeed relevant for patients as judged by themselves.","['community-dwelling patients with more than five drugs', ""139 patients' medication data"", 'community-dwelling patients with polypharmacy']",[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}]",[],[],,0.0394648,"In most medication regimens, complexity factors could be identified automatically, yet less than 15% of factors were indeed relevant for patients as judged by themselves.","[{'ForeName': 'Viktoria S', 'Initials': 'VS', 'LastName': 'Wurmbach', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Steffen J', 'Initials': 'SJ', 'LastName': 'Schmidt', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lampert', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Bernard', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Meid', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Frick', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Metzner', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wilm', 'Affiliation': 'Institute of General Practice (ifam), Centre for Health and Society (chs), Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Mortsiefer', 'Affiliation': 'Institute of General Practice (ifam), Centre for Health and Society (chs), Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Bücker', 'Affiliation': 'Institute of General Practice (ifam), Centre for Health and Society (chs), Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Altiner', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sparenberg', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Szecsenyi', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Peters-Klimm', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Kaufmann-Kolle', 'Affiliation': 'aQua-Institute for Applied Quality Improvement and Research in Health Care, Goettingen, Germany.'}, {'ForeName': 'Petra A', 'Initials': 'PA', 'LastName': 'Thürmann', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Walter E', 'Initials': 'WE', 'LastName': 'Haefeli', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Hanna M', 'Initials': 'HM', 'LastName': 'Seidling', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany. hanna.seidling@med.uni-heidelberg.de.'}]",European journal of clinical pharmacology,['10.1007/s00228-022-03314-1']
1806,35659904,Accuracy and efficacy of pre-dengue vaccination screening for previous dengue infection with a new dengue rapid diagnostic test: a retrospective analysis of phase 3 efficacy trials.,"BACKGROUND


A dengue pre-vaccination test that is convenient, highly specific, and highly sensitive is still needed. The OnSite Dengue IgG rapid diagnostic test (RDT) is a new rapid diagnostic test specifically designed for pre-vaccination screening. We aimed to retrospectively assess the efficacy of a tetravalent dengue vaccine (CYD-TDV) in participants determined to be dengue seropositive by the OnSite IgG RDT and to evaluate assay performances.
METHODS


This was a complementary study using pre-vaccination samples from two CYD-TDV efficacy trials done in five countries in the Asia-Pacific region (NCT01373281) and five countries in Latin America (NCT01374516). Baseline dengue serostatus was determined by the OnSite IgG RDT on samples from the immunogenicity subsets of the two trials. In participants who were test positive, we calculated CYD-TDV vaccine efficacy against symptomatic virologically confirmed dengue (VCD) over 25 months, and against hospitalisation with VCD over 72 months of follow-up after the first vaccination. We used a reference algorithm to determine the reference dengue serostatus for each sample, and sensitivity and specificity of the OnSite IgG RDT were calculated. Analyses were done on the whole population (aged 2-16 years), and on those aged 6 years or older and those aged 9 years or older.
FINDINGS


Of 3983 participants in the immunogenicity subsets of the efficacy trials CYD14 and CYD15, 3962 had complete dengue reference test results enabling baseline serostatus classification and 3833 had sufficient serum samples remaining for evaluation with the OnSite IgG RDT. Of the samples tested, 2486 (64·9%) of 3833 were OnSite IgG RDT-positive. In participants aged 2-16 years who were OnSite IgG RDT-positive, vaccine efficacy was 84·1% (95% CI 71·6-91·1) against symptomatic VCD, and 69·2% (38·8-84·5) against hospitalisation with VCD, with similar findings in those aged 6 years or older and those aged 9 years or older. The OnSite IgG RDT showed very high sensitivity (91·1%, 89·9-92·1) and high specificity (92·8%, 91·2-94·2) in participants aged 2-16 years, with significantly higher specificity in those aged 9 years or older (96·6%, 94·9-97·8).
INTERPRETATION


The OnSite IgG RDT should provide a valuable tool for screening for previous dengue infection at the point of vaccination. In individuals who were OnSite IgG RDT-positive, the vaccine efficacy of CYD-TDV was high across all three age groups.
FUNDING


Sanofi Pasteur.",2022,"The OnSite IgG RDT showed very high sensitivity (91·1%, 89·9-92·1) and high specificity (92·8%, 91·2-94·2) in participants aged 2-16 years, with significantly higher specificity in those aged 9 years or older (96·6%, 94·9-97·8).
","['participants determined to be dengue seropositive by the OnSite IgG RDT and to evaluate assay performances', 'participants aged 2-16 years who were OnSite IgG RDT-positive, vaccine efficacy was 84·1% (95% CI 71·6-91·1) against symptomatic VCD, and 69·2% (38·8-84·5) against hospitalisation with VCD, with similar findings in those aged 6 years or older and those aged 9 years or older', 'whole population (aged 2-16 years), and on those aged 6 years or older and those aged 9 years or older', '3983 participants in the immunogenicity subsets of the efficacy trials CYD14 and CYD15']","['pre-dengue vaccination screening', 'tetravalent dengue vaccine (CYD-TDV']",[],"[{'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}]",[],3983.0,0.311088,"The OnSite IgG RDT showed very high sensitivity (91·1%, 89·9-92·1) and high specificity (92·8%, 91·2-94·2) in participants aged 2-16 years, with significantly higher specificity in those aged 9 years or older (96·6%, 94·9-97·8).
","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Savarino', 'Affiliation': 'Translational Sciences and Biomarkers, Sanofi Pasteur, Swiftwater, PA, USA; Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: stephen.savarino@sanofi.com.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bonaparte', 'Affiliation': 'Global Clinical Immunology, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Clinical Sciences and Operations, Sanofi, Beijing, China.'}, {'ForeName': 'Gustavo H', 'Initials': 'GH', 'LastName': 'Dayan', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Forrat', 'Affiliation': ""Global Clinical Science, Sanofi Pasteur, Marcy l'Etoile, France.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Global Biostatistical Sciences, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Shekema', 'Initials': 'S', 'LastName': 'Hodge', 'Affiliation': 'Global Clinical Immunology, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Ataman-Önal', 'Affiliation': ""Translational Sciences and Biomarkers, Sanofi Pasteur, Marcy l'Etoile, France.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA, USA.'}]",The Lancet. Microbe,['10.1016/S2666-5247(22)00033-7']
1807,35693272,Effect of Laparoscopy Combined with Choledochoscope for the Treatment of Cholecystolithiasis and Choledocholithiasis.,"Objective


Evaluate the influence of laparoscopy combined with choledochoscopy on operation-related indexes, serum total bilirubin (TBIL) level, and abdominal drainage tube extraction time within cases carrying cholecystolithiasis/choledocholithiasis.
Methods


86 cases of cholecystolithiasis together with choledocholithiasis were chosen for this investigation, and cases were randomly segregated within the control cohort (43 cases, open surgery) and observation cohort (43 cases, laparoscopy combined with choledochoscopy).The operation-related indexes, complete stone clearance rate, postoperative visual analogue scale (VAS) scoring, serum TBIL level, and postsurgical complications/recovery incidence were observed and comparatively analyzed across cohorts.
Results


Compared with the control cohort, the incision length, operation duration, postoperative exhaust duration, abdominal drainage tube extraction time, and postsurgery hospitalization in observation cohort were markedly reduced ( P  < 0.05), the intrasurgical hemorrhaging was markedly reduced ( P  < 0.05), and the postoperative complication incidences were markedly reduced ( P  < 0.05). Furthermore, the complete stone clearance rates in the observation cohort were elevated compared with control, but the difference was not statistically significant ( P  > 0.05).VAS scoring for the observation cohort at 6, 12, 24, and 48 hours postsurgery was markedly reduced ( P  < 0.05). On the first day after the operation, the serum TBIL levels for the two cohorts were very high and gradually decreased, and the serum TBIL levels in the observation cohort were markedly reduced during day 1, 3, and 5 postsurgery ( P  < 0.05).
Conclusion


Laparoscopy combined with choledochoscopy surgical treatment might reduce the surgery duration, intrasurgery hemorrhaging, postsurgical pain, and liver function damage.",2022,"Compared with the control cohort, the incision length, operation duration, postoperative exhaust duration, abdominal drainage tube extraction time, and postsurgery hospitalization in observation cohort were markedly reduced ( P  < 0.05), the intrasurgical hemorrhaging was markedly reduced ( P  < 0.05), and the postoperative complication incidences were markedly reduced ( P  < 0.05).",['Cholecystolithiasis and Choledocholithiasis'],"['laparoscopy combined with choledochoscopy', 'Laparoscopy combined with choledochoscopy surgical treatment', 'laparoscopy combined with choledochoscopy).The operation', 'Laparoscopy Combined with Choledochoscope']","['serum TBIL levels', 'incision length, operation duration, postoperative exhaust duration, abdominal drainage tube extraction time, and postsurgery hospitalization', 'complete stone clearance rates', 'surgery duration, intrasurgery hemorrhaging, postsurgical pain, and liver function damage', 'stone clearance rate, postoperative visual analogue scale (VAS) scoring, serum TBIL level, and postsurgical complications/recovery incidence', 'operation-related indexes, serum total bilirubin (TBIL) level, and abdominal drainage tube extraction time', 'postoperative complication incidences', 'intrasurgical hemorrhaging']","[{'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0701818', 'cui_str': 'Cholelithiasis, Common Bile Duct'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0193519', 'cui_str': 'Choledochoscopy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0179907', 'cui_str': 'Choledochoscope'}]","[{'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",86.0,0.0250287,"Compared with the control cohort, the incision length, operation duration, postoperative exhaust duration, abdominal drainage tube extraction time, and postsurgery hospitalization in observation cohort were markedly reduced ( P  < 0.05), the intrasurgical hemorrhaging was markedly reduced ( P  < 0.05), and the postoperative complication incidences were markedly reduced ( P  < 0.05).","[{'ForeName': 'Chengxin', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""The First Department of General Surgery, Suzhou First People's Hospital, Anhui Province, Suzhou, Anhui 234000, China.""}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Deng', 'Affiliation': 'Hefei Cancer Hospital, Chinese Academy of Sciences, Hefei, Anhui 230000, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""The First Department of General Surgery, Suzhou First People's Hospital, Anhui Province, Suzhou, Anhui 234000, China.""}, {'ForeName': 'Duofu', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""The First Department of General Surgery, Suzhou First People's Hospital, Anhui Province, Suzhou, Anhui 234000, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': ""The First Department of General Surgery, Suzhou First People's Hospital, Anhui Province, Suzhou, Anhui 234000, China.""}, {'ForeName': 'Jinman', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Hefei Cancer Hospital, Chinese Academy of Sciences, Hefei, Anhui 230000, China.'}]",Computational and mathematical methods in medicine,['10.1155/2022/9110676']
1808,35700373,[Possibilities of complex rehabilitation of young children with epilepsy and movement disorders].,"Epilepsy is a chronic disease characterized by recurrent, mostly unprovoked seizures with impaired motor, autonomic, mental or mental functions that occur as a result of excessive neuronal discharges in the gray matter of the cerebral cortex. The problem of the activity of medical rehabilitation for epilepsy in the professional community remains debatable, despite the obviousness of the arguments and judgments presented.
PURPOSE OF THE STUDY


Development of an effective and safe complex for the rehabilitation of young children with epilepsy, accompanied by impaired movement function.
MATERIAL AND METHODS


The study included 123 young children (from 9 to 24 months) with epilepsy accompanied by impaired motor function. By the method of simple randomization, all patients were divided into 4 groups: 3 main groups and a comparison group. All children of the study groups, except for the comparison group, received medical rehabilitation: in the 1st group - classical massage with the exception of the cervical-collar zone; in the 2nd group - kinesitherapy according to the method of V. Voigt; in the 3rd group - a complex effect, including classical massage with the exclusion of the neck-collar zone and kinesitherapy according to the method of V. Voigt. Children of the comparison group received basic therapy. The effectiveness of medical rehabilitation was analyzed using the Gross motor function classification system (GMFCS) and the Griffiths intellectual development scale.
RESULTS


Differences in GMFCS scores before and after medical rehabilitation were statistically significant in group 3. In patients with impaired movement function and suffering from epilepsy, the positive dynamics during complex rehabilitation was more pronounced than when using one isolated technique.
CONCLUSION


Complexity in planning and prescribing a course of rehabilitation determines the greatest efficiency in reducing the deficit of physical activity. With an increase in the index of epileptiform activity according to electroencephalography data without any clinical manifestations, it is not required to cancel rehabilitation measures, it is necessary to strengthen control over the patient.",2022,"The effectiveness of medical rehabilitation was analyzed using the Gross motor function classification system (GMFCS) and the Griffiths intellectual development scale.
","['young children with epilepsy', '123 young children (from 9 to 24 months) with epilepsy accompanied by impaired motor function', 'young children with epilepsy and movement disorders']","['classical massage with the exclusion of the neck-collar zone and kinesitherapy according to the method of V. Voigt', 'basic therapy', 'classical massage with the exception of the cervical-collar zone; in the 2nd group - kinesitherapy', 'medical rehabilitation', 'complex rehabilitation']",['GMFCS scores'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C1096702', 'cui_str': 'Kinesitherapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",123.0,0.00601967,"The effectiveness of medical rehabilitation was analyzed using the Gross motor function classification system (GMFCS) and the Griffiths intellectual development scale.
","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Bukreeva', 'Affiliation': 'Voyno-Yasenetsky Scientific and Practical Center for Specialized Assistance to Children of Department of Health of Moscow, Moscow, Russia.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Sednenkova', 'Affiliation': 'Voyno-Yasenetsky Scientific and Practical Center for Specialized Assistance to Children of Department of Health of Moscow, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Kalyuzhny', 'Affiliation': 'Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sokolov', 'Affiliation': 'Voyno-Yasenetsky Scientific and Practical Center for Specialized Assistance to Children of Department of Health of Moscow, Moscow, Russia.'}, {'ForeName': 'E Yu', 'Initials': 'EY', 'LastName': 'Sergeenko', 'Affiliation': 'Voyno-Yasenetsky Scientific and Practical Center for Specialized Assistance to Children of Department of Health of Moscow, Moscow, Russia.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Laisheva', 'Affiliation': ""Separate structural subdivision of the Russian Children's Clinical Hospital Federal State Autonomous Educational Institution of Higher Education Pirogov Russian National Research Medical University of the Ministry of Health of Russia, Moscow, Russia.""}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20229903125']
1809,35700341,Phase 1 Single Ascending and Multiple Ascending Dose Studies of Phosphodiesterase-9 Inhibitor E2027: Confirmation of Target Engagement and Selection of Phase 2 Dose in Dementia With Lewy Bodies Trial.,"BACKGROUND


E2027 is a novel, highly selective and potent inhibitor of phosphodiesterase9 (PDE9) being evaluated as a treatment for dementia with Lewy bodies.
METHODS


Phase 1, randomized, double-blind, single ascending dose (SAD, n=96) and multiple ascending dose (MAD, n=68) studies evaluated E2027 doses (5 to 1200 mg) in healthy subjects. The impact of age, race (Japanese/non-Japanese), and food on pharmacokinetics (PK)/pharmacodynamics were evaluated. Serial cerebrospinal fluid (CSF) samples were collected to assess the target engagement.
RESULTS


E2027 PK profiles were biphasic (elimination half-life: ~30 hours. Approximately 3-fold accumulation was observed following multiple once-daily dosing. E2027 single doses of 50 to 400 mg resulted in mean maximum increases in CSF cyclic guanosine monophosphate ranging from 293% to 461% within 5.37 to 12.9 hours after dose administration to assess target engagement. Dose-response modelling of steady-state predose CSF cyclic guanosine monophosphate concentrations showed ≥200% increase from baseline is maintained with doses of ≥50 mg QD. The most common adverse events with E2027 were post-LP syndrome and back pain. PK profiles were similar between Japanese and non-Japanese. Higher exposure observed in fed versus fasted state was not considered clinically significant. PK exposure was higher in elderly subjects.
CONCLUSIONS


S.E2027 was well-tolerated following single and multiple administration. E2027 achieved maximal and sustained target engagement at 50 mg QD, the dose selected for the phase 2 clinical trial.",2022,PK profiles were similar between Japanese and non-Japanese.,"['elderly subjects', 'dementia with Lewy bodies', 'healthy subjects']","['Phosphodiesterase-9 Inhibitor E2027', 'phosphodiesterase9']","['Serial cerebrospinal fluid (CSF) samples', 'CSF cyclic guanosine monophosphate', 'PK profiles', 'PK exposure', 'steady-state predose CSF cyclic guanosine monophosphate concentrations']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0031640', 'cui_str': 'Phosphoric diester hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.145939,PK profiles were similar between Japanese and non-Japanese.,"[{'ForeName': 'Ishani S', 'Initials': 'IS', 'LastName': 'Landry', 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ.'}, {'ForeName': 'Jagadeesh', 'Initials': 'J', 'LastName': 'Aluri', 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Schuck', 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Ino', 'Affiliation': 'Eisai Co. Ltd., Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Horie', 'Affiliation': 'Eisai Co. Ltd., Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boyd', 'Affiliation': 'Eisai Ltd., Hatfield, UK.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Reyderman', 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lai', 'Affiliation': 'Eisai Ltd., Hatfield, UK.'}]",Alzheimer disease and associated disorders,['10.1097/WAD.0000000000000515']
1810,35700752,"Comparison of the effect of adding midazolam versus fentanyl to intrathecal levobupivacaine in patients undergoing cesarean section: double-blind, randomized clinical trial.","BACKGROUND


Many adjuvants are added to prolong the effects of spinal analgesia. We investigated the postoperative analgesic efficacy of the addition of midazolam or fentanyl to intrathecal levobupivacaine in women undergoing cesarean delivery.
METHODS


Eighty patients were randomly assigned to two groups (n = 40). Group M received 10 mg of 0.5% levobupivacaine plus 2 mg of midazolam. Group F received 10 mg of 0.5% levobupivacaine plus 25 μg of fentanyl. Assessments included motor and sensory block, APGAR score, time to first request for analgesia, postoperative pain score, total consumption of rescue analgesics, and adverse effects.
RESULTS


Sensory blockade was prolonged in Group M compared with Group F (215.58 ± 27.94 vs. 199.43 ± 19.77 min; p = 0.004), with no differences in other characteristics of the spinal block in intraoperative hemodynamics or APGAR score. The mean time to first request for rescue analgesia was longer in Group M (351.45 ± 11.05 min) than in Group F (268.83 ± 10.35 min; p = 0.000). The median total consumption of rescue analgesics in the first 24h postoperatively was 30 mg in Group M vs. 60 mg in Group F (p = 0.003). The median Visual Analog Scale (VAS) scores were lower in Group Ethan in Group F from the 8 th  to the 12 th hour postoperatively, with no differences between the groups at other time points. The incidence of adverse effects was higher in Group F than in Group M.
CONCLUSION


Intrathecal midazolam (2 mg) was superior to intrathecal fentanyl (25 μg) in increasing the duration of the sensory blockade and postoperative analgesia with lower postoperative pain scores and decreasing the incidence of adverse effects.",2022,"RESULTS


Sensory blockade was prolonged in Group M compared with Group F (215.58 ± 27.94 vs. 199.43 ± 19.77 min; p = 0.004), with no differences in other characteristics of the spinal block in intraoperative hemodynamics or APGAR score.","['Eighty patients', 'patients undergoing cesarean section', 'women undergoing cesarean delivery']","['levobupivacaine plus 25 μg of fentanyl', 'levobupivacaine plus 2 mg of midazolam', 'Intrathecal midazolam', 'fentanyl', 'midazolam', 'intrathecal levobupivacaine', 'midazolam or fentanyl to intrathecal levobupivacaine']","['incidence of adverse effects', 'median Visual Analog Scale (VAS) scores', 'median total consumption of rescue analgesics', 'adverse effects', 'postoperative analgesic efficacy', 'motor and sensory block, APGAR score, time to first request for analgesia, postoperative pain score, total consumption of rescue analgesics, and adverse effects', 'mean time to first request for rescue analgesia', 'intraoperative hemodynamics or APGAR score']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",80.0,0.262225,"RESULTS


Sensory blockade was prolonged in Group M compared with Group F (215.58 ± 27.94 vs. 199.43 ± 19.77 min; p = 0.004), with no differences in other characteristics of the spinal block in intraoperative hemodynamics or APGAR score.","[{'ForeName': 'Marwa Mahmoud', 'Initials': 'MM', 'LastName': 'Abdelrady', 'Affiliation': 'Assiut University, Faculty of Medicine, Anesthesia and Intensive Care Department, Assiut, Egypt. Electronic address: Marwarady@med.aun.edu.eg.'}, {'ForeName': 'Golnar Mohammed', 'Initials': 'GM', 'LastName': 'Fathy', 'Affiliation': 'Assiut University, Faculty of Medicine, Anesthesia and Intensive Care Department, Assiut, Egypt.'}, {'ForeName': 'Mohamed Abdelrady Mohamed', 'Initials': 'MAM', 'LastName': 'Abdallah', 'Affiliation': 'Assiut University, Faculty of Medicine, Anesthesia and Intensive Care Department, Assiut, Egypt.'}, {'ForeName': 'Wesam Nashat', 'Initials': 'WN', 'LastName': 'Ali', 'Affiliation': 'Assiut University, Faculty of Medicine, Anesthesia and Intensive Care Department, Assiut, Egypt.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2022.06.001']
1811,35700691,Lack of Clinical Relevance of Bilastine-Food Interaction in Healthy Volunteers: A Wheal and Flare Study.,"INTRODUCTION


The aim of this study was to compare the pharmacodynamic activity of bilastine administered under fasting and fed conditions in healthy volunteers.
METHODS


In this randomized, open-label, two-period, crossover study involving 24 healthy subjects, once-daily oral bilastine 20 mg was administered for 4 days under fasting and fed conditions, with a 7-day washout period. Bilastine plasma concentrations were measured for 24 h after the first and fourth doses in each period. Pharmacodynamic activity was assessed by wheal and flare surface inhibition and subjective assessment of itching, after intradermal injection of histamine 5 μg.
RESULTS


When administered under fed versus fasting conditions, exposure to bilastine 20 mg decreased (mean maximum plasma concentration and area under the curve from time 0 to 24 h decreased by 34.27% and 32.72% [day 1], respectively, and 33.08% and 28.87% [day 4]). Despite this, the antihistaminic effect of bilastine 20 mg was not altered by food. On day 1, as assessed by wheal and flare surface inhibition, the maximum effect and duration of action of bilastine did not differ to a significant extent between fasting and fed conditions, with only a short 30-min delay in the onset of wheal inhibition. At steady state (day 4), bilastine's pharmacodynamic effects were not significantly affected under fasting or fed conditions.
CONCLUSION


The pharmacokinetic interaction of bilastine with food does not imply a significant reduction of its peripheral antihistaminic efficacy. Despite a slight delay in onset of action on the first treatment day, the global clinical efficacy of bilastine is not affected by coadministration with food.",2022,The pharmacokinetic interaction of bilastine with food does not imply a significant reduction of its peripheral antihistaminic efficacy.,"['healthy volunteers', '24 healthy subjects', 'Healthy Volunteers']","['bilastine', 'Bilastine-Food Interaction']","['maximum plasma concentration and area under the curve from time 0 to 24 h', 'wheal and flare surface inhibition, the maximum effect and duration of action of bilastine', 'Pharmacodynamic activity', ""bilastine's pharmacodynamic effects"", 'Bilastine plasma concentrations', 'pharmacodynamic activity', 'peripheral antihistaminic efficacy']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1101148', 'cui_str': 'bilastine'}, {'cui': 'C0242784', 'cui_str': 'Food interaction'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0221232', 'cui_str': 'Weal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1101148', 'cui_str': 'bilastine'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",24.0,0.0231348,The pharmacokinetic interaction of bilastine with food does not imply a significant reduction of its peripheral antihistaminic efficacy.,"[{'ForeName': 'Jimena', 'Initials': 'J', 'LastName': 'Coimbra', 'Affiliation': ""Centre d'Investigació de Medicaments (CIM), Institut de Recerca i d'Investigació Biomèdica de l'Hospital de la Santa Creu i Sant Pau (IIB-Sant Pau), Barcelona, Spain.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Puntes', 'Affiliation': ""Centre d'Investigació de Medicaments (CIM), Institut de Recerca i d'Investigació Biomèdica de l'Hospital de la Santa Creu i Sant Pau (IIB-Sant Pau), Barcelona, Spain.""}, {'ForeName': 'Ignasi', 'Initials': 'I', 'LastName': 'Gich', 'Affiliation': 'Department of Epidemiology, Hospital de la Santa Creu i Sant Pau, CIM - Caiber - IIb Sant Pau, Universitat Autónoma de Barcelona (UAB), Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martínez', 'Affiliation': ""Centre d'Investigació de Medicaments (CIM), Institut de Recerca i d'Investigació Biomèdica de l'Hospital de la Santa Creu i Sant Pau (IIB-Sant Pau), Barcelona, Spain.""}, {'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Molina', 'Affiliation': ""Centre d'Investigació de Medicaments (CIM), Institut de Recerca i d'Investigació Biomèdica de l'Hospital de la Santa Creu i Sant Pau (IIB-Sant Pau), Barcelona, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Antonijoan', 'Affiliation': ""Department of Clinical Pharmacology, Hospital de la Santa Creu i Sant Pau, Centre d'Investigació de Medicaments (CIM), Institut d'Investigació Biomèdica Sant Pau, Caiber- IIB-Sant Pau, Department of Pharmacology and Therapeutics, Universitat Autónoma de Barcelona (UAB), Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Campo', 'Affiliation': 'Medical Department, FAES FARMA S. A., Leioa (Vizcaya), Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Labeaga', 'Affiliation': 'Medical Department, FAES FARMA S. A., Leioa (Vizcaya), Spain.'}]",International archives of allergy and immunology,['10.1159/000524856']
1812,35700594,Taurine as a possible antiaging therapy: A controlled clinical trial on taurine antioxidant activity in women ages 55 to 70.,"OBJECTIVE


Based on the antioxidant effects of taurine, which are capable of controlling oxidative stress in the aging process, the aim of this study was to investigate the effects of taurine supplementation on biomarkers of oxidative stress in women 55 to 70 y of age.
METHODS


A double-blind study was conducted with 24 women (61.4 ± 4.2 y, body mass index 31.4 ± 5.1 kg/m²). The participants were randomly assigned to either a control group (GC, n = 11), supplemented with placebo (1.5 g of starch); or a taurine group (GTAU, n = 13), supplemented with taurine (1.5 g), for 16 wk. As primary outcomes, taurine and oxidative stress marker levels were determined in plasma samples. Anthropometry, functional capacity testing, and plasma mineral levels were evaluated as secondary outcomes. The evaluations were performed pre- and postintervention. Food consumption was assessed before, during, and after the intervention. The results were analyzed by two-way repeated analysis of variance measures mixed model, with the Sidak post hoc (P < 0.05).
RESULTS


Taurine and superoxide dismutase (SOD, antioxidant enzyme) plasma levels were increased in the GTAU group. SOD levels also were higher than in the GC group after supplementation. Glutathione reductase levels decreased regardless of the intervention. Malondialdehyde levels increased only in the GC participants.
CONCLUSION


Taurine supplementation prevented the decrease in the antioxidant enzyme SOD, suggesting taurine as a strategy to control oxidative stress during the aging process.",2022,"RESULTS


Taurine and superoxide dismutase (SOD, antioxidant enzyme) plasma levels were increased in the GTAU group.","['women ages 55 to 70', '24 women (61.4 ± 4.2 y, body mass index 31.4 ± 5.1 kg/m²', 'women 55 to 70 y of age']","['Taurine supplementation', 'taurine group (GTAU, n\xa0=\xa013), supplemented with taurine', 'GC', 'taurine', 'Taurine', 'control group (GC, n\xa0=\xa011), supplemented with placebo', 'taurine supplementation']","['SOD levels', 'Malondialdehyde levels', 'Food consumption', 'Glutathione reductase levels', 'Anthropometry, functional capacity testing, and plasma mineral levels', 'taurine and oxidative stress marker levels', 'Taurine and superoxide dismutase (SOD, antioxidant enzyme) plasma levels', 'oxidative stress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0017824', 'cui_str': 'Glutathione reductase (NAD(P)H)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}]",,0.243678,"RESULTS


Taurine and superoxide dismutase (SOD, antioxidant enzyme) plasma levels were increased in the GTAU group.","[{'ForeName': 'Gabriela Ferreira', 'Initials': 'GF', 'LastName': 'Abud', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of Sao Paulo - FCF UNESP, Araraquara, Sao Paulo, Brazil.'}, {'ForeName': 'Flavia Giolo', 'Initials': 'FG', 'LastName': 'De Carvalho', 'Affiliation': 'School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo -EEFERP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Batitucci', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of Sao Paulo - FCF UNESP, Araraquara, Sao Paulo, Brazil.'}, {'ForeName': 'Sofia Germano', 'Initials': 'SG', 'LastName': 'Travieso', 'Affiliation': 'Department of Health Sciences, Ribeirao Preto Medical School, University of Sao Paulo - FMRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Carlos Roberto', 'Initials': 'CR', 'LastName': 'Bueno Junior', 'Affiliation': 'School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo -EEFERP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Barbosa Junior', 'Affiliation': 'Department of Clinical, Toxicologic and Bromatological Analysis, College of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo - FCFRP USP, Ribeirao Preto, Sao Paulo, Brazil.'}, {'ForeName': 'Julio Sergio', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Internal Medicine Department, Ribeirao Preto Medical School, University of Sao Paulo - FMRP USP, Ribeirao Preto, São Paulo, Brazil.'}, {'ForeName': 'Ellen Cristini', 'Initials': 'EC', 'LastName': 'de Freitas', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of Sao Paulo - FCF UNESP, Araraquara, Sao Paulo, Brazil; School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo -EEFERP USP, Ribeirao Preto, Sao Paulo, Brazil; Department of Health Sciences, Ribeirao Preto Medical School, University of Sao Paulo - FMRP USP, Ribeirao Preto, Sao Paulo, Brazil. Electronic address: ellenfreitas@usp.br.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2022.111706']
1813,35700592,Coenzyme Q10 supplementation improves cholesterol efflux capacity and antiinflammatory properties of high-density lipoprotein in Chinese adults with dyslipidemia.,"OBJECTIVES


Coenzyme Q10 (CoQ10) had shown promising effects in improving the lipid and glycemic profile in dyslipidemic individuals in our previous work, but little is known about how it affects high-density lipoprotein (HDL) function in patients with dyslipidemia. The aim of this study was to explore the effects of CoQ10 supplementation on HDL function in people with dyslipidemia.
METHODS


A 24-wk, randomized, double-blind, placebo-controlled trial was conducted in 101 people with dyslipidemia. All patients were randomized into the CoQ10 group (120 mg/d, n = 51) or the placebo group (n = 50). High-density lipoprotein-mediated cholesterol efflux capacity (CEC), HDL inflammatory index (HII), and HDL intrinsic oxidation were measured at baseline, 12 wk, and 24 wk.
RESULTS


CoQ10 supplementation for 24 wk significantly improved HDL-mediated CEC (mean change, 1.21±2.44 versus -0.12±2.94; P = 0.014) and reduced HII (mean change, -0.32±0.58 versus -0.05±0.49, P = 0.014) compared with placebo. However, there was no significant difference in the effect of CoQ10 on HDL intrinsic oxidation between the two groups after 24 wk (P = 0.290). A positive correlation was found between the changes in CEC and HDL cholesterol in the CoQ10 group (r, 0.30; P = 0.032). Furthermore, we also found that the improved HDL functions were more obvious in elderly, female, or non-obese individuals, which indicated a specific population that benefits most from CoQ10 intervention.
CONCLUSIONS


This study suggested that supplementation of CoQ10 for 24 wk can significantly improve HDL-mediated CEC and antiinflammatory function of HDL in patients with dyslipidemia.",2022,"CoQ10 supplementation for 24 wk significantly improved HDL-mediated CEC (mean change, 1.21±2.44 versus -0.12±2.94; P = 0.014) and reduced HII (mean change, -0.32±0.58 versus -0.05±0.49, P = 0.014) compared with placebo. ","['Chinese adults with dyslipidemia', 'patients with dyslipidemia', 'people with dyslipidemia', 'dyslipidemic individuals', '101 people with dyslipidemia']","['Coenzyme Q10 (CoQ10', 'Coenzyme Q10 supplementation', 'CoQ10', 'placebo', 'CoQ10 supplementation']","['HDL function', 'HDL intrinsic oxidation', 'HDL-mediated CEC', 'reduced HII', 'High-density lipoprotein-mediated cholesterol efflux capacity (CEC), HDL inflammatory index (HII), and HDL intrinsic oxidation', 'HDL-mediated CEC and antiinflammatory function of HDL', 'CEC and HDL cholesterol', 'HDL functions']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",101.0,0.316459,"CoQ10 supplementation for 24 wk significantly improved HDL-mediated CEC (mean change, 1.21±2.44 versus -0.12±2.94; P = 0.014) and reduced HII (mean change, -0.32±0.58 versus -0.05±0.49, P = 0.014) compared with placebo. ","[{'ForeName': 'Jinchao', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, China; Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Zezhong', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China.'}, {'ForeName': 'Xiaofen', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China; Department of Radiotherapy, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yuheng', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China.'}, {'ForeName': 'Kongyao', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China.'}, {'ForeName': 'Qiuhua', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, China; Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Guangzhou, China; Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China. Electronic address: yangyan3@mail.sysu.edu.cn.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2022.111703']
1814,35700588,"Immunomodulating versus high-protein oral preoperative supplement in surgical patients - A two-center, prospective, randomized clinical trial.","OBJECTIVES


For many years, immunonutrition was believed to reduce postoperative complications in patients undergoing major abdominal surgery. However, recent studies questioned that belief. Moreover, the perioperative intake of proteins has gained more and more attention and has shown clinical value. Therefore, the aim of this study was to compare the clinical effect of immunomodulating (IM) plus high-protein (HP) and pure HP supplements during the preoperative period.
METHODS


Between January 2011 and December 2020, 299 well-nourished patients (130 female and 169 male; mean age: 60.8 y) undergoing major abdominal surgery at two surgical centers were randomized to receive either preoperative IM or HP oral supplements for 7 d after surgery. In all patients, an enhanced recovery after surgery protocol was applied. Outcome measures of the intend-to-treat analysis were number and type of complications, length of hospitalization, and mortality.
RESULTS


Both groups were comparable in terms of age, sex, and type of surgery. The median length of postoperative hospital stay was 8 d (range, 6-12 d) in the IM group and 7 d (range, 6-10 d) in the HP group (P = 0.153). Postoperative complications were observed in 29 patients (21.3%) in the IM group and 28 (17.8%) in the HP group (P = 0.442) The risk of readmission was comparable (5.1% vs 4.9%; P = 0.924) for IM and HP supplements, respectively. Postoperative nausea and vomiting occurred in 21 patients in the IM group (15.4%) and 17 patients in the HP group (10.4%; P = 0.195). No difference in gastrointestinal function evaluated with time to first flatus was observed (P = 0.272) CONCLUSIONS: The study demonstrated no difference between preoperative IM + HP and HP supplements in surgical patients. Therefore, the routine preoperative use of IM supplements in all surgical patients cannot be recommended.",2022,No difference in gastrointestinal function evaluated with time to first flatus was observed (P = 0.272),"['surgical patients - A two-center', 'patients undergoing major abdominal surgery', 'surgical patients', 'Between January 2011 and December 2020, 299 well-nourished patients (130 female and 169 male; mean age: 60.8 y) undergoing major abdominal surgery at two surgical centers']","['preoperative IM\xa0+\xa0HP and HP supplements', 'Immunomodulating versus high-protein oral preoperative supplement', 'preoperative IM or HP oral supplements', 'immunomodulating (IM) plus high-protein (HP) and pure HP supplements']","['number and type of complications, length of hospitalization, and mortality', 'postoperative complications', 'Postoperative complications', 'risk of readmission', 'gastrointestinal function evaluated with time to first flatus', 'median length of postoperative hospital stay', 'Postoperative nausea and vomiting']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C2364291', 'cui_str': 'Well nourished'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",,0.0642446,No difference in gastrointestinal function evaluated with time to first flatus was observed (P = 0.272),"[{'ForeName': 'Stanislaw', 'Initials': 'S', 'LastName': 'Klek', 'Affiliation': 'Surgical Oncology Clinic, The Maria Sklodowska-Curie National Cancer Institute, Krakow, Poland. Electronic address: klek@poczta.onet.pl.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Kret', 'Affiliation': 'Surgical Oncology Clinic, The Maria Sklodowska-Curie National Cancer Institute, Krakow, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Choruz', 'Affiliation': ""General Surgery Unit with Intestinal Failure Center, Stanley Dudrick's Memorial Hospital, Skawina, Poland.""}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Pisarska-Adamczyk', 'Affiliation': 'Department of Medical Education, Jagiellonian University Medical College. Cracow, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Salowka', 'Affiliation': ""General Surgery Unit with Intestinal Failure Center, Stanley Dudrick's Memorial Hospital, Skawina, Poland.""}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Cegielny', 'Affiliation': ""General Surgery Unit with Intestinal Failure Center, Stanley Dudrick's Memorial Hospital, Skawina, Poland.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Welanyk', 'Affiliation': 'Surgical Oncology Clinic, The Maria Sklodowska-Curie National Cancer Institute, Krakow, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Wilczek', 'Affiliation': 'Surgical Oncology Clinic, The Maria Sklodowska-Curie National Cancer Institute, Krakow, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Pedziwiatr', 'Affiliation': 'Second Department of General Surgery, Jagiellonian University Medical College, Department of Endoscopic, Metabolic and Soft Tissue Tumors Surgery, Krakow, Poland.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2022.111701']
1815,35701080,Skills assessment after a grape-based microsurgical course for ophthalmology residents: randomised controlled trial.,"AIMS


To introduce and assess a course using grapes as training models for ophthalmology residents to acquire basic microsurgical skills.
METHODS


Ophthalmology residents who were novices at microsurgery were included. Participants were randomised into a 1:1 ratio to a 4-hour training programme based on fruit models (group A) or virtual reality (VR) modulator and silicone suture pads (group B), respectively. Before and after training, questionnaires were designed to measure their self-confidence with ophthalmic operations and with their coming role as surgical assistants. After training, each participant provided their interest in further studying microsurgery and was assessed for their general competence of ophthalmic microsurgery on porcine eyes.
RESULTS


Eighty-three participants were included, with 42 ones in group A and 41 ones in group B. After training, participants in group A performed better in the uniformities of the suture span (p<0.05), suture thickness (p<0.05) and tissue protection (p<0.05) during the corneal suturing assessment. The overall scores of corneal suturing and circular capsulorhexis in the porcine eye in group A were comparable to those in group B (p=0.26 and 0.87, respectively). Group A showed a more positive attitude to withstand the training for more than 4 hours (p<0.001), as well as a higher willingness to receive more times of the training in the future (p<0.001).
CONCLUSIONS


Training models based on grapes are equal to VR simulators and silicon suture pads to provide solid training tasks for ophthalmology residents to master basic microsurgical skills, and might have advantages in lower economic cost, and easy availability.
TRIAL REGISTRATION NUMBER


ChiCTR2000040439.",2022,"The overall scores of corneal suturing and circular capsulorhexis in the porcine eye in group A were comparable to those in group B (p=0.26 and 0.87, respectively).","['Ophthalmology residents who were novices at microsurgery were included', 'ophthalmology residents', 'ophthalmology residents to acquire basic microsurgical skills', 'Eighty-three participants were included, with 42 ones in group A and 41 ones in group']","['suture thickness (p<0.05) and tissue protection (p<0.05) during the corneal suturing assessment', '4-hour training programme based on fruit models (group A) or virtual reality (VR) modulator and silicone suture pads']","['overall scores of corneal suturing and circular capsulorhexis', 'positive attitude']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0332568', 'cui_str': 'Pad'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0525027', 'cui_str': 'Anterior capsulorrhexis'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}]",83.0,0.0290377,"The overall scores of corneal suturing and circular capsulorhexis in the porcine eye in group A were comparable to those in group B (p=0.26 and 0.87, respectively).","[{'ForeName': 'Zhaotian', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Songshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Jinglin', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Mengke', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Danying', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China dingxiaoyan@gzzoc.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2022-321135']
1816,35701050,Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT).,"INTRODUCTION


Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown aetiology. Results from previous studies indicate that, across both diseases, increased levels of illness-related anxiety and dysfunctional symptom expectations contribute to symptom persistence. Thus, comparing both disorders with regard to common and disease-specific factors in the persistence and modification of gastrointestinal symptoms seems justified. Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies.
METHODS AND ANALYSIS


To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). Both active intervention groups will comprise three individual online consultation sessions and a booster session after 3 months. The primary outcome is baseline to postinterventional change in gastrointestinal symptom severity.
ETHICS AND DISSEMINATION


The study was approved by the Ethics Committee of the Hamburg Medical Association (2020-10198-BO-ff). The study will shed light onto the efficacy and mechanisms of action of a targeted expectation management intervention for persistent gastrointestinal symptoms in patients with UC and IBS. Furthermore, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies.
TRIAL REGISTRATION NUMBER


ISRCTN30800023.",2022,"Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies.
","['irritable bowel syndrome and ulcerative colitis', 'patients with UC and IBS', 'adult patients with UC and IBS', '117 patients with UC and 117 patients with IBS']","['equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control']",['baseline to postinterventional change in gastrointestinal symptom severity'],"[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",117.0,0.0826729,"Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies.
","[{'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany b.loewe@uke.de.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Nestoriuc', 'Affiliation': 'Department of Psychology, Helmut Schmidt University, University of the Federal Armed Forces, Hamburg, Germany.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Andresen', 'Affiliation': 'Medical Clinic, Israelitic Hospital, Hamburg, Germany.'}, {'ForeName': 'Eik', 'Initials': 'E', 'LastName': 'Vettorazzi', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Hübener', 'Affiliation': 'Department of Medicine I, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Maehder', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Peters', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ansgar W', 'Initials': 'AW', 'LastName': 'Lohse', 'Affiliation': 'Department of Medicine I, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2021-059529']
1817,35698087,Collaborative care compared to enhanced standard treatment of depression with co-morbid medical conditions among patients from rural South India: a cluster randomized controlled trial (HOPE Study).,"BACKGROUND


Depression is common among primary care patients in LMIC but treatments are largely ineffective. In this cluster-randomized controlled trial, we tested whether depression outcomes are different among recipients of a collaborative care model compared to enhanced standard treatment in patients with co-morbid chronic medical conditions.
METHODS


We conducted a cluster randomized controlled trial among participants 30 years or older seeking care at 49 primary health centers (PHCs) in rural Karnataka, diagnosed with major depressive disorder, dysthymia, generalized anxiety disorder, or panic disorder on the MINI-International Neuropsychiatric Interview plus either hypertension, diabetes, or ischemic heart disease. From a list of all PHCs in the district, 24 PHCs were randomized a priori to deliver collaborative care and 25 PHCs enhanced standard treatment. The collaborative care model consisted of a clinic-based and a community-based component. Study assessment staff was blinded to treatment arm allocation. The primary outcome was the individual-level PHQ-9 score over time.
RESULTS


Between May 2015 and Nov 2018, 2486 participants were enrolled, 1264 in the control arm, and 1222 in the intervention arm. They were assessed at baseline, 3, 6 and 12 months. The mean PHQ-9 depression score was around 8.5 at baseline. At each follow-up PHQ-9 scores were significantly lower in the intervention (5.24, 4.81 and 4.22 at respective follow-ups) than in the control group (6.69, 6.13, 5.23, respectively). A significant time-by-treatment interaction (p < 0.001) in a multi-level model over all waves, nested within individuals who were nested within PHCs, confirmed that the decrease in depression score from baseline was larger for collaborative care than enhanced standard care throughout follow-up.
CONCLUSIONS


The collaborative care intervention resulted in significantly lower depression scores compared to enhanced standard care among participants with co-morbid physical conditions. The findings have potential implications for integrating mental health and chronic disease treatment in resource constrained settings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02310932 , registered on December 8, 2014, and Clinical Trials Registry India CTRI/2018/04/013001 , registered on April 4, 2018. Retrospectively registered.",2022,The collaborative care intervention resulted in significantly lower depression scores compared to enhanced standard care among participants with co-morbid physical conditions.,"['patients with co-morbid chronic medical conditions', 'participants 30\u2009years or older seeking care at 49 primary health centers (PHCs) in rural Karnataka, diagnosed with major depressive disorder, dysthymia, generalized anxiety disorder, or panic disorder on the MINI-International Neuropsychiatric Interview plus either hypertension, diabetes, or ischemic heart disease', 'participants with co-morbid physical conditions', 'primary care patients in LMIC', 'Between May 2015 and Nov 2018, 2486 participants were enrolled, 1264 in the control arm, and 1222 in the intervention arm', 'patients from rural South India']","['Collaborative care', 'collaborative care and 25 PHCs enhanced standard treatment', 'collaborative care intervention']","['mean PHQ-9 depression score', 'individual-level PHQ-9 score over time', 'depression score', 'PHQ-9 scores', 'depression scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",2486.0,0.254395,The collaborative care intervention resulted in significantly lower depression scores compared to enhanced standard care among participants with co-morbid physical conditions.,"[{'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's Research Institute, Bangalore, India.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Heylen', 'Affiliation': 'Division of Prevention Sciences, University of California, San Francisco, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Johnson Pradeep', 'Affiliation': ""Department of Psychiatry, St John's Medical College, Bangalore, India.""}, {'ForeName': 'Prem K', 'Initials': 'PK', 'LastName': 'Mony', 'Affiliation': ""Division of Epidemiology and Community Health, St John's Medical College & Research Institute, Bangalore, India.""}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's Research Institute, Bangalore, India. Maria.Ekstrand@ucsf.edu.""}]",BMC psychiatry,['10.1186/s12888-022-04000-3']
1818,35698074,Implementation and evaluation of an individualized physical exercise promotion program in people with manifested risk factors for multimorbidity (MultiPill-Exercise): a study protocol for a pragmatic randomized controlled trial.,"BACKGROUND


Multimorbidity is a major problem in Europe, increasing the need for prevention and rehabilitation programs. In Germany no guidelines have been developed that focus on patients with multiple chronic non-communicable diseases (NCDs). Benefits of physical activity (PA) and exercise in NCDs have been proven, but most interventions focus on single conditions. The evaluation of the effectiveness, efficiency and safety of PA programs in patients suffering from multiple NCDs and the feasibility of the implementation within the health care service remain open research questions.
METHODS


The multi-site randomized controlled pragmatic trial includes 320 sedentary subjects with at least two of the following NCDs, either manifested or in a pre-stage with evident risk factors: Cardio-vascular disease, Diabetes mellitus type 2, knee/ hip osteoarthritis and obesity. Participants will be recruited from general practitioners and medical specialists and randomized to standard care of a statutory health insurance or MultiPill-Exercise. Standard care includes a choice of one or a maximum of two 8- to 12-week health programs, including nutrition, exercise, relaxation or special disease management programs. MultiPill-Exercise is based on the bio-psycho-social health model, considering a person-oriented perspective in light of given individual characteristics and context factors. The 24-weeks intervention focuses on aerobic and strengthening exercises in line with the WHO PA recommendations. Psychological and pedagogical elements along with behavior change techniques are implemented to ease the initiation and maintenance of exercise participation and lifestyle change, including nutrition. Primary outcome will be short- and long-term PA measured with the European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ). Secondly, the effectiveness of the program on generic, disease specific, economic, and exercise behavioral parameters, as well as program adherence and safety will be evaluated.
DISCUSSION


Results of this trial evaluate the PA intervention program in people with multiple NCDs in a real-life scenario. It will serve as a proof of concept with the opportunity of translation into routine practice. This approach, as a multi-site RCT with its rigorous methods and standardized operating procedures for the conduction of the intervention, will allow valid conclusions for the implementation of PA interventions in people with multimorbidity.
TRIAL REGISTRATION


The trial was registered at www.drks.de (ID: DRKS00025033 ) on 30th September 2021.",2022,"Secondly, the effectiveness of the program on generic, disease specific, economic, and exercise behavioral parameters, as well as program adherence and safety will be evaluated.
","['320 sedentary subjects with at least two of the following NCDs, either manifested or in a pre-stage with evident risk factors: Cardio-vascular disease, Diabetes mellitus type 2, knee/ hip osteoarthritis and obesity', 'patients with multiple chronic non-communicable diseases (NCDs', 'people with manifested risk factors for multimorbidity (MultiPill-Exercise', 'people with multiple NCDs in a real-life scenario', 'Participants will be recruited from general practitioners and medical specialists and randomized to', 'people with multimorbidity', 'patients suffering from multiple NCDs']","['PA intervention program', 'MultiPill-Exercise', 'standard care of a statutory health insurance or MultiPill-Exercise', 'nutrition, exercise, relaxation or special disease management programs', 'physical activity (PA) and exercise', 'individualized physical exercise promotion program', 'aerobic and strengthening exercises']","['effectiveness, efficiency and safety', 'generic, disease specific, economic, and exercise behavioral parameters', 'short- and long-term PA measured with the European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",320.0,0.0063853,"Secondly, the effectiveness of the program on generic, disease specific, economic, and exercise behavioral parameters, as well as program adherence and safety will be evaluated.
","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Schweda', 'Affiliation': 'Department of Sports Medicine, Faculty of Medicine, University Hospital, Medical Clinic, Hoppe-Seyler Str. 6, 72076, Tuebingen, Germany. simone.schweda@med.uni-tuebingen.de.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Müller', 'Affiliation': 'Allgemeine Ortskrankenkasse AOK Baden-Wuerttemberg, Presselstrasse 19, 70191, Stuttgart, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Munz', 'Affiliation': 'Department of Sports Medicine, Faculty of Medicine, University Hospital, Medical Clinic, Hoppe-Seyler Str. 6, 72076, Tuebingen, Germany.'}, {'ForeName': 'Gorden', 'Initials': 'G', 'LastName': 'Sudeck', 'Affiliation': 'Interfaculty Research Institute for Sports and Physical Activity, Tuebingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Department for Clinical Epidemiology and Applied Biostatistics, Faculty of Medicine, University Hospital, Medical Clinic, Silcherstrasse 5, 72076, Tuebingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Dierkes', 'Affiliation': 'Interfaculty Research Institute for Sports and Physical Activity, Tuebingen, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Krauss', 'Affiliation': 'Department of Sports Medicine, Faculty of Medicine, University Hospital, Medical Clinic, Hoppe-Seyler Str. 6, 72076, Tuebingen, Germany.'}]",BMC public health,['10.1186/s12889-022-13400-9']
1819,35698072,The effect of a planned lactation education program on the mother's breastfeeding practice and weight gain in low birth weight infants: a randomized clinical trial study.,"BACKGROUND


Low birth weight (LBW) infants are more prone to possible growth disorders, and their mothers need more specific education sessions regarding breastfeeding practice. This study aimed to investigate the effect of a planned lactation education program on the mother's breastfeeding practice and weight gain in LBW infants.
METHODS


A randomized clinical trial study was conducted on 80 mother-LBW infant dyads admitted to a gynecology and obstetrics hospital. The participants were selected randomly and divided into an experimental group and a control group, each with 40 mothers. Information on LBW infants' weight and the mothers' breastfeeding practice was collected using a questionnaire at birth. Then, a planned lactation education program was implemented in the experimental group in two sessions in the hospital and three 20-minute sessions in comprehensive health centers. Finally, the weight of 14-15 day-old and two-month-old LBW infants and the mothers' breastfeeding practice for 14-15 day-old LBW infants in the two groups were recollected and analyzed using SPSS software version 16.
RESULTS


Comparing the LBW infants' weights and mothers' breastfeeding practice revealed no statistically significant difference between the two groups pre-intervention. However, significant differences were observed between the two groups post-intervention in terms of weight gain in the LBW infants over 14-15 days and two months of age (F = 4720.6, p < 0.001) and the mothers' breastfeeding practice for 14-15-day-old infants (p < 0.001).
CONCLUSIONS


Given the positive impact of lactation education on the mother's breastfeeding practice and LBW infants' weight, planned lactation education courses should be applied for LBW infants' mothers.
TRIAL REGISTRATION


This study was retrospectively registered in the Clinical Trial Registration Center of Iran, with the code: IRCT20120215009014N421 on 14/04/2022.",2022,"However, significant differences were observed between the two groups post-intervention in terms of weight gain in the LBW infants over 14-15 days and two months of age (F = 4720.6, p < 0.001) and the mothers' breastfeeding practice for 14-15-day-old infants (p < 0.001).
","['80 mother-LBW infant dyads admitted to a gynecology and obstetrics hospital', 'low birth weight infants', 'LBW infants', ""LBW infants' mothers""]",['planned lactation education program'],"[""mothers' breastfeeding practice"", 'weight gain', ""LBW infants' weight and the mothers' breastfeeding practice""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",80.0,0.0240771,"However, significant differences were observed between the two groups post-intervention in terms of weight gain in the LBW infants over 14-15 days and two months of age (F = 4720.6, p < 0.001) and the mothers' breastfeeding practice for 14-15-day-old infants (p < 0.001).
","[{'ForeName': 'Afsar', 'Initials': 'A', 'LastName': 'Omidi', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Rahmani', 'Affiliation': 'Community Health Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Hamadan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Amini', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Chronic Diseases (Home care) Research Center, Hamadan University of Medical Sciences, Shahid Fahmideh Avenue, Hamadan, Iran. aminiroy@gmail.com.'}, {'ForeName': 'Manoochehr', 'Initials': 'M', 'LastName': 'Karami', 'Affiliation': 'Department of Epidemiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC pregnancy and childbirth,['10.1186/s12884-022-04810-z']
1820,35698043,The effect of individual counseling based on the GATHER principles on perceived stress and empowerment of the mothers with high-risk pregnancies: an experimental study.,"BACKGROUND


High-risk pregnancy causes different responses, including negative emotions, feelings of vulnerability and psychological stress in the mother. The aim of this study was to investigate the effect of individual counseling on the empowerment and the perceived stress of high-risk pregnant mothers.
METHODS


This study was a two-group experimental study. The study was performed on 82 high-risk pregnant women hospitalized in Fatemieh Hospital in Hamadan, Iran. Inclusion criteria were high-risk pregnancy, being literate, gestational age 24 to 36 weeks. The samples were divided into experimental and control groups using randomized block design. Data were collected using Cohen's perceived stress scale and Kameda empowerment questionnaires. For the experimental group, four sessions of individual counseling according to GATHER principles (Greet, Ask, Tell, Help, Explain, and Return) were performed for 45-60 minutes for two consecutive weeks. SPSS 25 software was used for data analysis.
RESULTS


The mean score of the perceived stress after the intervention in the control and experimental groups were 27.07(5.80) and 25.30(4.95), respectively (P = 0.097). There was a substantial difference in the mean score of empowerment 84.76)9.14) and 88.75 (6.17) (P < 0.001) and different dimensions of empowerment (self-efficacy, Future image, self-esteem, Support and assurance from others) between the control and intervention groups after the intervention.
CONCLUSIONS


The findings of this study indicate individual counseling is effective in empowering the mothers with high-risk pregnancy but has no significant effect on their perceived stress.",2022,"(P < 0.001) and different dimensions of empowerment (self-efficacy, Future image, self-esteem, Support and assurance from others) between the control and intervention groups after the intervention.
","['Inclusion criteria were high-risk pregnancy, being literate, gestational age 24 to 36\u2009weeks', '82 high-risk pregnant women hospitalized in Fatemieh Hospital in Hamadan, Iran', 'mothers with high-risk pregnancy', 'mothers with high-risk pregnancies', 'high-risk pregnant mothers']",['individual counseling'],"['dimensions of empowerment (self-efficacy, Future image, self-esteem, Support and assurance from others', 'mean score of the perceived stress', 'negative emotions, feelings of vulnerability and psychological stress', 'stress scale and Kameda empowerment questionnaires']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242786', 'cui_str': 'High risk pregnancy'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",82.0,0.0394896,"(P < 0.001) and different dimensions of empowerment (self-efficacy, Future image, self-esteem, Support and assurance from others) between the control and intervention groups after the intervention.
","[{'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Aliabadi', 'Affiliation': 'Department of Mother and Child Health, Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of medical sciences, Hamadan, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Shayan', 'Affiliation': 'Department of Midwifery and Reproductive Health, Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of medical sciences, Hamadan, Iran.'}, {'ForeName': 'Mansoureh', 'Initials': 'M', 'LastName': 'Refaei', 'Affiliation': 'Department of Mother and Child Health, Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of medical sciences, Hamadan, Iran. mansourehrefaei@yahoo.com.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Tapak', 'Affiliation': 'Department of Biostatistics, School of Public Health, Modeling of Noncommunicable Diseases Research Center, Hamadan University of medical sciences, Hamadan, Iran.'}, {'ForeName': 'Latif', 'Initials': 'L', 'LastName': 'Moradveisi', 'Affiliation': 'Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",BMC psychiatry,['10.1186/s12888-022-04047-2']
1821,35698001,The Effect of Alfentanil on Emergence Delirium Following General Anesthesia in Children: A Randomized Clinical Trial.,"BACKGROUND


Emergence delirium can occur after general anesthesia in children. An intravenous infusion of alfentanil may reduce the incidence or severity of emergence delirium after sevoflurane anesthesia.
OBJECTIVE


The study aimed to investigate the effects of alfentanil intravenous infusion on emergence delirium and other perioperative complications.
METHOD


This was a single-center, randomized, placebo-controlled, double-blind clinical trial. A total of 172 children undergoing ambulatory dental treatment were randomized into three groups. Alfentanil group Alf2 received 0.2 μg/kg/min of alfentanil for continuous infusion, alfentanil group Alf4 received 0.4 μg/kg/min alfentanil, and the saline group (group Sal) received a continuous infusion of normal saline, with the same volume as the two other groups, as a placebo. The incidence of emergence delirium (assessed by the Paediatric Anaesthesia Emergence Delirium [PAED] scale), hemodynamic parameters, and recovery characteristics were recorded during the recovery period. The Aono scale was also used to assess for emergence delirium. A WeChat applet was designed to facilitate a caregiver teleconsultation and to provide feedback on postoperative nausea and vomiting and any other complications after discharge.
RESULTS


The incidence of emergence delirium in group Alf2 (22.9%) and group Alf4 (21.1%) was significantly lower than that observed in the Sal group (48.3%). The PAED scores in group Alf2 (6.4 ± 3.5) and group Alf4 (5.8 ± 3.8) were significantly lower than those for group Sal (9.6 ± 5.1) (p < 0.01). Ten children in the Alf4 group needed manual ventilatory assistance to maintain end-tidal carbon dioxide (ETCO 2 ) < 55 mm; children in group Alf2 did not. There was no significant difference between the discharge time of groups Alf2 and Sal (31.2 ± 4.64 vs 30.5 ± 2.82 min; 0.659 [95% confidence interval {CI} -1.052 to 2.369], p = 0.643); the time to discharge of group Alf4 (35.16 ± 3.97 min) was significantly longer than that of groups Alf2 and Sal (p < 0.01). The incidence of nausea and vomiting was similar in the three groups. No other clinically relevant adverse events were observed.
CONCLUSIONS


Intravenous infusion of 0.2 μg/kg/min and 0.4 μg/kg/min alfentanil decreased the incidence of emergence delirium in the post-anesthesia care unit. The 0.2 μg/kg/min dose of alfentanil resulted in less respiratory depression and discharge delay than the 0.4 μg/kg/min alfentanil dose.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR2100043320).",2022,"The 0.2 μg/kg/min dose of alfentanil resulted in less respiratory depression and discharge delay than the 0.4 μg/kg/min alfentanil dose.
","['children', '172 children undergoing ambulatory dental treatment', 'Emergence Delirium Following General Anesthesia in Children']","['continuous infusion of normal saline', 'alfentanil intravenous infusion', 'Alfentanil', 'alfentanil group', 'placebo', 'alfentanil']","['discharge time', 'PAED scores', 'respiratory depression and discharge delay', 'incidence of emergence delirium', 'nausea and vomiting', 'Paediatric Anaesthesia Emergence Delirium [PAED] scale), hemodynamic parameters, and recovery characteristics', 'postoperative nausea and vomiting', 'manual ventilatory assistance to maintain end-tidal carbon dioxide']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C1278442', 'cui_str': 'Continuous infusion of normal saline'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]",172.0,0.306619,"The 0.2 μg/kg/min dose of alfentanil resulted in less respiratory depression and discharge delay than the 0.4 μg/kg/min alfentanil dose.
","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Stomatological Hospital of Chongqing Medical University, 426 Songshi North Road, Yubei District, Chongqing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Stomatological Hospital of Chongqing Medical University, 426 Songshi North Road, Yubei District, Chongqing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Anesthesiology, Stomatological Hospital of Chongqing Medical University, 426 Songshi North Road, Yubei District, Chongqing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Stomatological Hospital of Chongqing Medical University, 426 Songshi North Road, Yubei District, Chongqing, China.'}, {'ForeName': 'YuJia', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Stomatological Hospital of Chongqing Medical University, 426 Songshi North Road, Yubei District, Chongqing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Stomatological Hospital of Chongqing Medical University, 426 Songshi North Road, Yubei District, Chongqing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Stomatological Hospital of Chongqing Medical University, 426 Songshi North Road, Yubei District, Chongqing, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Stomatological Hospital of Chongqing Medical University, 426 Songshi North Road, Yubei District, Chongqing, China. 500158@hospital.cqmu.edu.cn.'}]",Paediatric drugs,['10.1007/s40272-022-00510-5']
1822,35698000,Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study.,"BACKGROUND


The efficacy and safety of biologic treatments for children and adolescents with moderate to severe psoriasis should be examined over a considerable time period and in different subgroups.
OBJECTIVE


We report the efficacy and safety of secukinumab low dose (LD) and high dose (HD) regimens in pediatric patients with moderate to severe psoriasis for up to Week 52.
METHODS


This was a randomized, open-label, parallel-group, multicenter study in patients aged  6 to < 18 years. Patients were randomized in a 1:1 ratio to receive LD (75/75/150 mg; N = 42) or HD (75/150/300 mg; N = 42) subcutaneous secukinumab. At randomization, patients were stratified by weight (< 25, 25 to < 50, ≥ 50 kg) and disease severity (moderate/severe). The study is ongoing; the present analysis included data up to Week 52 collected from August 29, 2018 (first patient first visit) to May 28, 2020 (last patient last visit for Week 52). Efficacy was measured using Investigator's Global Assessment modified 2011 0/1 (IGA 0/1) and Psoriasis Area Severity Index (PASI) 75/90/100 response. Safety outcomes included assessment of adverse events.
RESULTS


Of the 84 enrolled patients, 78 (92.9%) completed 52 weeks of treatment. Overall, response rates for PASI 75 and IGA 0/1 were similar between the LD (92.8/88.9%) and HD (93.3/84.7%) groups at Week 52. In the LD and HD groups, PASI 90/100 responses at Week 52 were 78.7/53.5% and 84.7/70.0%, respectively. The proportions of IGA 0/1 and PASI 75/90 responders were comparable for the age, body weight, and disease severity subgroups in the secukinumab LD and HD groups. Mean absolute PASI change from baseline at week 52 was - 17.3 ± standard deviation 5.0 and - 18.2 ± 7.0, a percentage change of - 94.3 and - 94.5% for the LD and HD groups, respectively. More than 70% of evaluable patients achieved Children's Dermatology Life Quality Index 0/1 at Week 52 (LD 70.7%; HD 70.3%). The safety profile was consistent with that in adults, with no new safety signals for either secukinumab dosing regimen.
CONCLUSION


A high proportion of pediatric patients with psoriasis responded to both dosing regimens of secukinumab and maintained clinical responses through 52 weeks of treatment. No clinical difference was observed in the efficacy of secukinumab across the pediatric subgroups. Safety events were consistent with the established safety profile of secukinumab.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03668613.",2022,"Overall, response rates for PASI 75 and IGA 0/1 were similar between the LD (92.8/88.9%) and HD (93.3/84.7%) groups at Week 52.","['Pediatric Patients with Moderate to Severe Plaque Psoriasis', 'patients aged \xa06 to <\xa018 years', 'analysis\xa0included data up to Week 52 collected from August 29, 2018 (first patient first visit) to May 28, 2020 (last patient last visit for Week 52', 'pediatric patients with moderate to severe psoriasis for up to Week\xa052', 'patients were stratified by weight (<\xa025, 25 to <\xa050, ≥\xa050 kg) and disease severity (moderate/severe', 'children and adolescents with moderate to severe psoriasis', 'pediatric patients with\xa0psoriasis', 'Of the 84 enrolled patients, 78 (92.9%) completed 52 weeks of treatment']","['secukinumab', 'secukinumab low\xa0dose (LD) and high\xa0dose (HD) regimens', 'Secukinumab', 'HD (75/150/300 mg; N\xa0=\xa042) subcutaneous secukinumab', 'LD']","['adverse events', 'Psoriasis Area Severity Index (PASI) 75/90/100 response', 'Efficacy', ""Children's Dermatology Life Quality Index"", 'Mean absolute PASI change', 'response rates']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",84.0,0.084875,"Overall, response rates for PASI 75 and IGA 0/1 were similar between the LD (92.8/88.9%) and HD (93.3/84.7%) groups at Week 52.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Magnolo', 'Affiliation': 'University Hospital Münster, Münster, Germany. Nina.Magnolo@ukmuenster.de.'}, {'ForeName': 'Külli', 'Initials': 'K', 'LastName': 'Kingo', 'Affiliation': 'Tartu University Hospital and University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Laquer', 'Affiliation': 'First OC Dermatology, Fountain Valley, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browning', 'Affiliation': 'University of Texas Health Science Center San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Reich', 'Affiliation': 'Department of Dermatology, Institute of Medical Science, Medical College of Rzeszów University, Rzeszów, Poland.'}, {'ForeName': 'Jacek C', 'Initials': 'JC', 'LastName': 'Szepietowski', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wrocław, Poland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Philemon', 'Initials': 'P', 'LastName': 'Papanastasiou', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Bao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Forrer', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Manmath', 'Initials': 'M', 'LastName': 'Patekar', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Paediatric drugs,['10.1007/s40272-022-00507-0']
1823,35697958,Efficacy and moderating factors of the Early Start Denver Model in Chinese toddlers with autism spectrum disorder: a longitudinal study.,"BACKGROUND


Several studies have shown the effectiveness of the Early Start Denver Model (ESDM), but few studies have explored the long-term efficacy of ESDM. This study aimed to explore the efficacy and moderating factors of ESDM in Chinese toddlers with autism spectrum disorder (ASD) in a longitudinal way.
METHODS


A total of 60 toddlers with ASD were recruited and randomly divided into two groups: ESDM group all received 24 weeks intervention; Control group were waiting for intervention. Baseline assessment (T0) was conducted before intervention, including Gesell Developmental Scale (GDS) and Psycho-educational Profile-3rd Edition (PEP-3). All toddlers with ASD were examined in the first assessment (T1) at 6 months and in the second assessment (T2) at 12 months.
RESULTS


In T1 assessment, the increments in speech and personal communication development quotient in GDS were significantly larger in the ESDM group than in the control group (P = 0.010, 0.047). In T2 assessment, the ESDM group had higher elevation in cognitive verbal/preverbal (CVP), social reciprocity and characteristic verbal behaviors assessed by PEP-3 (P = 0.021, 0.046, 0.014). In addition, the severity of stereotyped behavior was negatively associated with improvement in CVP. Family income was positively associated with improvement in speech and CVP (all P < 0.05).
CONCLUSIONS


ESDM can effectively improve speech and communication in toddlers with ASD after 24-week intervention. More importantly, ESDM can promote cognition and social interaction and can reduce stereotyped verbal behavior in toddlers with ASD in longitudinal observation. The severity of stereotyped behavior and family ecological factors may be considered as affecting the efficacy of ESDM.",2022,"In T1 assessment, the increments in speech and personal communication development quotient in GDS were significantly larger in the ESDM group than in the control group (P = 0.010, 0.047).","['60 toddlers with ASD', 'Chinese toddlers with autism spectrum disorder (ASD', 'toddlers with ASD', 'Chinese toddlers with autism spectrum disorder', 'All toddlers with ASD']","['ESDM', 'ESDM group all received 24\xa0weeks intervention; Control group were waiting for intervention']","['stereotyped verbal behavior', 'severity of stereotyped behavior', 'increments in speech and personal communication development quotient in GDS', 'speech and communication', 'speech and CVP', 'CVP', 'Gesell Developmental Scale (GDS) and Psycho-educational Profile-3rd Edition (PEP-3', 'cognitive verbal/preverbal (CVP), social reciprocity and characteristic verbal behaviors assessed by PEP-3']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}]","[{'cui': 'C0042530', 'cui_str': 'Verbal Behavior'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0086792', 'cui_str': 'Personal Communication'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]",60.0,0.0134179,"In T1 assessment, the increments in speech and personal communication development quotient in GDS were significantly larger in the ESDM group than in the control group (P = 0.010, 0.047).","[{'ForeName': 'Shi-Huan', 'Initials': 'SH', 'LastName': 'Wang', 'Affiliation': 'Child Developmental and Behavioral Center, The Third Affiliated Hospital of Sun Yat-sen University, No. 600, Tianhe Road, Guangzhou, 510630, China.'}, {'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Zhang', 'Affiliation': 'Child Developmental and Behavioral Center, The Third Affiliated Hospital of Sun Yat-sen University, No. 600, Tianhe Road, Guangzhou, 510630, China.'}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Zou', 'Affiliation': 'Child Developmental and Behavioral Center, The Third Affiliated Hospital of Sun Yat-sen University, No. 600, Tianhe Road, Guangzhou, 510630, China.'}, {'ForeName': 'San-Mei', 'Initials': 'SM', 'LastName': 'Cheng', 'Affiliation': 'Child Developmental and Behavioral Center, The Third Affiliated Hospital of Sun Yat-sen University, No. 600, Tianhe Road, Guangzhou, 510630, China.'}, {'ForeName': 'Xiao-Bing', 'Initials': 'XB', 'LastName': 'Zou', 'Affiliation': 'Child Developmental and Behavioral Center, The Third Affiliated Hospital of Sun Yat-sen University, No. 600, Tianhe Road, Guangzhou, 510630, China. zouxb@mail.sysu.edu.cn.'}, {'ForeName': 'Kai-Yun', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Child Developmental and Behavioral Center, The Third Affiliated Hospital of Sun Yat-sen University, No. 600, Tianhe Road, Guangzhou, 510630, China. chenkaiy@mail.sysu.edu.cn.'}]",World journal of pediatrics : WJP,['10.1007/s12519-022-00555-z']
1824,35698577,Nutrition for Hospital Workers During a Crisis: Effect of a Plant-Based Dietary Intervention on Cardiometabolic Outcomes and Quality of Life in Healthcare Employees During the COVID-19 Pandemic.,"The study tested the effects of a vegan diet on cardiometabolic outcomes and quality of life among healthcare employees during the COVID-19 pandemic. Overweight hospital employees were enrolled and randomly assigned (in a 1:1 ratio) to an intervention group, which was asked to follow a low-fat vegan diet, or a control group, asked to make no diet changes. However, due to COVID-19 disruptions, all participants remained on their usual diets from March to June (12 weeks), creating a de facto control period, and all (n = 12) started the vegan diet with online classes in June, which continued for 12 weeks. Nine participants completed all final assessments. A crossover ANOVA was used for statistical analysis of differences in cardiovascular health during the control period and during the intervention. Despite the ongoing crisis, body weight decreased (treatment effect -5.7 kg [95% CI -9.7 to -1.7];  P  = .01); fasting plasma glucose decreased (-11.4 mg/dL [95% CI -18.8 to -4.1];  P  = .007); total and LDL-cholesterol decreased (-30.7 mg/dL [95% CI -53.8 to -7.5];  P  = .02; and -24.6 mg/dL [-44.8 to -4.3];  P  = .02, respectively); diastolic blood pressure decreased (-8.5 mm Hg [95% CI -16.3 to -.7];  P  = .03); and quality of life increased ( P  = .005) during the intervention period, compared with the control period. A vegan diet improved cardiometabolic outcomes and quality of life in healthcare workers at the height of the COVID-19 pandemic.",2022,A vegan diet improved cardiometabolic outcomes and quality of life in healthcare workers at the height of the COVID-19 pandemic.,"['Healthcare Employees During the COVID-19 Pandemic', 'Hospital Workers During a Crisis', 'healthcare employees during the COVID-19 pandemic', 'Overweight hospital employees', 'Hg']","['Plant-Based Dietary Intervention', 'vegan diet', 'dL']","['cardiovascular health', 'Cardiometabolic Outcomes and Quality of Life', 'quality of life', 'fasting plasma glucose', 'body weight', 'total and LDL-cholesterol', 'cardiometabolic outcomes and quality of life', ' diastolic blood pressure']","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0344353', 'cui_str': 'Vegan'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",9.0,0.0368997,A vegan diet improved cardiometabolic outcomes and quality of life in healthcare workers at the height of the COVID-19 pandemic.,"[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Kahleova', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC, USA, (HK, DH, AG, NDB); Adjunct Faculty, George Washington University School of Medicine and Health Sciences, Washington, DC, USA, (NDB); University of Maryland School of Medicine, Baltimore City, MD, USA, (RBL); Sibley Memorial Hospital, Washington, DC, USA, (HG, RS); School of Medicine, University of Utah, Salt Lake City, UT, USA, (RH).'}, {'ForeName': 'Rickisha', 'Initials': 'R', 'LastName': 'Berrien-Lopez', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC, USA, (HK, DH, AG, NDB); Adjunct Faculty, George Washington University School of Medicine and Health Sciences, Washington, DC, USA, (NDB); University of Maryland School of Medicine, Baltimore City, MD, USA, (RBL); Sibley Memorial Hospital, Washington, DC, USA, (HG, RS); School of Medicine, University of Utah, Salt Lake City, UT, USA, (RH).'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Holtz', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC, USA, (HK, DH, AG, NDB); Adjunct Faculty, George Washington University School of Medicine and Health Sciences, Washington, DC, USA, (NDB); University of Maryland School of Medicine, Baltimore City, MD, USA, (RBL); Sibley Memorial Hospital, Washington, DC, USA, (HG, RS); School of Medicine, University of Utah, Salt Lake City, UT, USA, (RH).'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC, USA, (HK, DH, AG, NDB); Adjunct Faculty, George Washington University School of Medicine and Health Sciences, Washington, DC, USA, (NDB); University of Maryland School of Medicine, Baltimore City, MD, USA, (RBL); Sibley Memorial Hospital, Washington, DC, USA, (HG, RS); School of Medicine, University of Utah, Salt Lake City, UT, USA, (RH).'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Sheinberg', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC, USA, (HK, DH, AG, NDB); Adjunct Faculty, George Washington University School of Medicine and Health Sciences, Washington, DC, USA, (NDB); University of Maryland School of Medicine, Baltimore City, MD, USA, (RBL); Sibley Memorial Hospital, Washington, DC, USA, (HG, RS); School of Medicine, University of Utah, Salt Lake City, UT, USA, (RH).'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Gujral', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC, USA, (HK, DH, AG, NDB); Adjunct Faculty, George Washington University School of Medicine and Health Sciences, Washington, DC, USA, (NDB); University of Maryland School of Medicine, Baltimore City, MD, USA, (RBL); Sibley Memorial Hospital, Washington, DC, USA, (HG, RS); School of Medicine, University of Utah, Salt Lake City, UT, USA, (RH).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC, USA, (HK, DH, AG, NDB); Adjunct Faculty, George Washington University School of Medicine and Health Sciences, Washington, DC, USA, (NDB); University of Maryland School of Medicine, Baltimore City, MD, USA, (RBL); Sibley Memorial Hospital, Washington, DC, USA, (HG, RS); School of Medicine, University of Utah, Salt Lake City, UT, USA, (RH).'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Barnard', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC, USA, (HK, DH, AG, NDB); Adjunct Faculty, George Washington University School of Medicine and Health Sciences, Washington, DC, USA, (NDB); University of Maryland School of Medicine, Baltimore City, MD, USA, (RBL); Sibley Memorial Hospital, Washington, DC, USA, (HG, RS); School of Medicine, University of Utah, Salt Lake City, UT, USA, (RH).'}]",American journal of lifestyle medicine,['10.1177/15598276211050339']
1825,35698581,Improvement in Health-Related Quality of Life with Dupilumab in Patients with Moderate-to-Severe Asthma with Comorbid Chronic Rhinosinusitis with/without Nasal Polyps: An Analysis of the QUEST Study.,"Patients with asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, increasing disease burden and complicating treatment. These post hoc analyses investigated disease-specific health-related quality of life (HRQoL) and general health status in the randomized, placebo-controlled QUEST study (NCT02414854) in patients treated with dupilumab for moderate-to-severe asthma with comorbid CRS. Patients received 300 mg of dupilumab or placebo every 2 weeks for 52 weeks. CRS HRQoL was assessed by the 22-item Sino-Nasal Outcome Test (SNOT-22; items scored 0-5). The 22 items are categorized into 5 domains (nasal, ear/facial, sleep, function, and emotion), and patients report the top 5 most important items affecting their health. General health status was assessed by Euro-QoL visual analog scale (EQ-VAS). Of 1902 patients, 382 (20.1%) self-reported comorbid CRS; 193 patients receiving dupilumab 300 mg q2w or matched placebo were included in this analysis. At baseline, the most impacted SNOT-22 domain was nasal, and general health status was below population norms. Patients rated ""decreased sense of taste/smell,"" ""nasal blockage,"" ""cough,"" ""reduced productivity,"" and ""wake up tired"" as the 5 most important SNOT-22 items affecting their health. Percentage change from baseline in SNOT-22 total score was significantly greater for dupilumab vs placebo at Weeks 24, 36, and 52 (all  p  < 0.05). Improvements from baseline were significantly greater for dupilumab vs placebo at Week 52 for all SNOT-22 domains ( p  < 0.05), except emotion. At Week 52, significant changes from baseline with dupilumab vs placebo were observed for all 5 most important SNOT-22 items affecting their health (all  p  < 0.05). EQ-VAS was significantly improved with dupilumab vs placebo by Week 12, with improvements sustained to Week 52 (all  p  < 0.01). In patients with moderate-to-severe asthma who self-reported comorbid CRS, dupilumab treatment vs placebo improved CRS-specific HRQoL and general health status.",2022,"Percentage change from baseline in SNOT-22 total score was significantly greater for dupilumab vs placebo at Weeks 24, 36, and 52 (all  p  < 0.05).","['Patients with Moderate-to-Severe Asthma with Comorbid Chronic Rhinosinusitis with/without Nasal Polyps', 'Patients with asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, increasing disease burden and complicating treatment', 'patients treated with dupilumab for moderate-to-severe asthma with comorbid CRS', 'patients with moderate-to-severe asthma who self-reported comorbid CRS, dupilumab treatment vs', 'Of 1902 patients, 382 (20.1%) self-reported comorbid CRS; 193 patients receiving']","['dupilumab 300 mg q2w or matched placebo', 'dupilumab vs placebo', 'dupilumab or placebo', 'placebo']","['EQ-VAS', 'Health-Related Quality of Life', 'CRS HRQoL', 'SNOT-22 total score', 'sense of taste/smell,"" ""nasal blockage,"" ""cough,"" ""reduced productivity,"" and ""wake up tired', 'disease-specific health-related quality of life (HRQoL) and general health status', 'Euro-QoL visual analog scale (EQ-VAS', 'CRS-specific HRQoL and general health status', 'General health status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4517750', 'cui_str': '382'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]",1902.0,0.124273,"Percentage change from baseline in SNOT-22 total score was significantly greater for dupilumab vs placebo at Weeks 24, 36, and 52 (all  p  < 0.05).","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hopkins', 'Affiliation': ""Department of Otorhinolaryngology - Head and Neck Surgery, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Buchheit', 'Affiliation': ""Division of Allergy and Clinical Immunology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Heffler', 'Affiliation': 'Personalized Medicine, Asthma & Allergy - Humanitas Clinical and Research Center IRCCS, Milan, Italy.'}, {'ForeName': 'Noam A', 'Initials': 'NA', 'LastName': 'Cohen', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Olze', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Asif H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'Global Medical Affairs, Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Msihid', 'Affiliation': 'Health Economics and Value Assessment, Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Nash', 'Affiliation': 'Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Juby A', 'Initials': 'JA', 'LastName': 'Jacob-Nara', 'Affiliation': 'Global Medical Affairs, Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Rowe', 'Affiliation': 'Global Medical Affairs, Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Yamo', 'Initials': 'Y', 'LastName': 'Deniz', 'Affiliation': 'Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}]",Journal of asthma and allergy,['10.2147/JAA.S363527']
1826,35698580,Efficacy and Safety of Masitinib in Corticosteroid-Dependent Severe Asthma: A Randomized Placebo-Controlled Trial.,"Background


Masitinib is an oral tyrosine kinase inhibitor that selectively targets mast cell activity and platelet-derived growth factor receptor (PDGFR) signaling, both of which are implicated in various mechanisms of asthma pathogenesis.
Objective


Assessment of masitinib as an add-on to standard maintenance therapy as compared with placebo in the treatment of oral corticosteroid-dependent severe asthma.
Methods


We conducted a randomized (2:1), placebo-controlled study of masitinib (6 mg/kg/d) in adults with severe asthma uncontrolled by high dose inhaled corticosteroids and long-acting beta-adrenoreceptor agonists plus oral corticosteroids (OCS) (≥7.5 mg/d). No minimum baseline blood eosinophil count was specified. Following a protocol amendment, the primary endpoint was reduction of annualized severe asthma exacerbation rate adjusted for the overall time on treatment (SAER). Subgroup analysis according to yearly cumulative OCS intake was also performed, a higher OCS dose indicating more severe asthma that is harder to control.
Results


Following an average exposure of approximately 13 months, masitinib (n = 240) reduced the SAER by 35% relative to placebo (n = 115) (rate ratio (RR) 0.65 (95% CI [0.47-0.90]; P = 0.010)). For patients with eosinophil ≥150 cell/µL, masitinib (n = 181) reduced SAER by 38% relative to placebo (n = 87); RR 0.62 (95% CI [0.42-0.91]; P = 0.016). Benefit of masitinib was shown to increase in the most severely affected patients (OCS intake of >1000 mg/year), with a significant (P < 0.01) reduction in SAER of 50%-70%. Safety was consistent with the known masitinib profile.
Conclusion


Orally administered masitinib reduces the risk of asthma exacerbations in severe asthma patients, with an acceptable safety profile. Masitinib may potentially provide a new treatment option for oral corticosteroid-dependent severe asthma.",2022,"For patients with eosinophil ≥150 cell/µL, masitinib (n = 181) reduced SAER by 38% relative to placebo (n = 87); RR 0.62 (95% CI [0.42-0.91]; P = 0.016).","['≥7.5 mg/d', 'oral corticosteroid-dependent severe asthma', 'Corticosteroid-Dependent Severe Asthma', 'adults with severe asthma uncontrolled by high dose inhaled corticosteroids and long-acting beta', 'severe asthma patients']","['adrenoreceptor agonists plus oral corticosteroids (OCS', 'Masitinib', 'masitinib', 'placebo', 'Placebo']","['minimum baseline blood eosinophil count', 'Efficacy and Safety', 'reduction of annualized severe asthma exacerbation rate adjusted for the overall time on treatment (SAER', 'risk of asthma exacerbations', 'SAER']","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2351398', 'cui_str': 'masitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}]",,0.459264,"For patients with eosinophil ≥150 cell/µL, masitinib (n = 181) reduced SAER by 38% relative to placebo (n = 87); RR 0.62 (95% CI [0.42-0.91]; P = 0.016).","[{'ForeName': 'Lavinia', 'Initials': 'L', 'LastName': 'Davidescu', 'Affiliation': 'Department of Pulmonology, University of Oradea, Oradea, Romania.'}, {'ForeName': 'Grigoriy', 'Initials': 'G', 'LastName': 'Ursol', 'Affiliation': 'Medical and Diagnostic Center of Private Enterprise of Private Production Company ""Acinus"", Kropyvnytskyi, Ukraine.'}, {'ForeName': 'Oleksii', 'Initials': 'O', 'LastName': 'Korzh', 'Affiliation': 'Department of General Practice - Family Medicine, Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine.'}, {'ForeName': 'Vikranth', 'Initials': 'V', 'LastName': 'Deshmukh', 'Affiliation': 'Department of Pulmonary Medicine, Respira Hospital, Nagpur, Maharashtra, India.'}, {'ForeName': 'Lesia', 'Initials': 'L', 'LastName': 'Kuryk', 'Affiliation': 'National Institute of Phthisiology and Pulmonology Named After F.G. Yanovsky of National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine.'}, {'ForeName': 'Monja-Marie', 'Initials': 'MM', 'LastName': 'Nortje', 'Affiliation': 'Moriana Clinical Research, Brandfort, South Africa.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Godlevska', 'Affiliation': 'Department of General Practice - Family Medicine, Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Devouassoux', 'Affiliation': 'Department of Pulmonology, Hôpital de la Croix Rousse, GHN, HCL and Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Khodosh', 'Affiliation': 'Department of Pulmonology, Municipal Nonprofit Enterprise, City Clinical Hospital #13, Kharkiv, Ukraine.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Moussy', 'Affiliation': 'AB Science, Paris, France.'}, {'ForeName': 'Colin D', 'Initials': 'CD', 'LastName': 'Mansfield', 'Affiliation': 'AB Science, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'AB Science, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Chanez', 'Affiliation': 'Clinique des Bronches, Allergie et Sommeil, APHM Hôpital Nord, C2VN Center INSERM INRAE UMR1062, Aix-Marseille Université, Marseille, France.'}]",Journal of asthma and allergy,['10.2147/JAA.S337284']
1827,35698556,Effect of education on physical and occupational therapists' perceptions of clinical practice guidelines and shared decision making: a randomized controlled trial.,"[Purpose] This study aimed to investigate the influence of the evidence practice gap on physiotherapist and occupational therapists through shared decision making using the clinical practice guidelines. [Participants and Methods] A randomized controlled trial was used. The participants included 126 therapists from three institutions. The inclusion criteria was permanent employment in these institutions. Participants' characteristics were masked from the allocator, evaluator, and analyzer. For the intervention group, a workshop on shared decision making was conducted using clinical practice guidelines. Two control groups were set. One group received a lecture on the knowledge of clinical practice guidelines, and the other group received a lecture on the knowledge of shared decision making. The primary outcomes were ""education, attitudes and beliefs, and interest and perceived role in evidence-based practice"" scale. [Results] The primary outcomes showed a significant difference between the clinical practice guidelines with shared decision making group and the clinical practice guidelines group (mean ± standard deviation, pre/post; clinical practice guidelines with shared decision making group, 2.4 ± 0.9/4.4 ± 1.7; clinical practice guidelines group, 3.0 ± 1.5/3.5 ± 2.0; shared decision making group, 2.6 ± 1.2/ 3.3 ± 1.8). [Conclusion] Shared decision making education using the clinical practice guidelines improves evidence-based practice of self-efficacy in physiotherapists and occupational therapists.",2022,"The primary outcomes showed a significant difference between the clinical practice guidelines with shared decision making group and the clinical practice guidelines group (mean ± standard deviation, pre/post; clinical practice guidelines with shared decision making group, 2.4 ± 0.9/4.4 ± 1.7; clinical practice guidelines group, 3.0 ± 1.5/3.5 ± 2.0; shared decision making group, 2.6 ± 1.2/ 3.3 ± 1.8).","['Participants and Methods', 'participants included 126 therapists from three institutions']",[],"['education, attitudes and beliefs, and interest and perceived role in evidence-based practice"" scale']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]",[],"[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",126.0,0.0882937,"The primary outcomes showed a significant difference between the clinical practice guidelines with shared decision making group and the clinical practice guidelines group (mean ± standard deviation, pre/post; clinical practice guidelines with shared decision making group, 2.4 ± 0.9/4.4 ± 1.7; clinical practice guidelines group, 3.0 ± 1.5/3.5 ± 2.0; shared decision making group, 2.6 ± 1.2/ 3.3 ± 1.8).","[{'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Graduate School of Public Health, Shizuoka Graduate University of Public Health: 4-27-2 Kita-ando, Aoi-ku, Shizuoka city, Shizuoka 420-0881, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Kio University Graduate School of Health Science, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Komukai', 'Affiliation': 'Department of Graduate School of Public Health, Shizuoka Graduate University of Public Health: 4-27-2 Kita-ando, Aoi-ku, Shizuoka city, Shizuoka 420-0881, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Health Informatics, Kyoto University Graduate School of Public Health, Japan.'}]",Journal of physical therapy science,['10.1589/jpts.34.445']
1828,35698670,Comparison of Hemodynamic Response to Laryngoscopy Using Miller and McCoy Blade.,"BACKGROUND


The most commonly used equipment to aid endotracheal intubation is a laryngoscope, and the procedure performed is known as laryngoscopy, which leads to profound cardiovascular effects. The process of laryngoscopy causes the release of catecholamines, thereby leading to marked pressor responses and tachycardia. The process of laryngoscopy can be made easier by the use of various types of laryngoscopic blades. The McCoy blade is a modification of the standard Macintosh blade that incorporates a hinged tip blade. It allows elevation of the epiglottis while decreasing overall laryngeal movement. A Miller blade is a straight blade with a slight upward curve near the tip. It is found that the force exerted, head extension, and cervical spine movement are less with the Miller blade. This study was undertaken to compare changes in haemodynamic parameters before, during, and after laryngoscopy using these two blades.
MATERIALS AND METHODS


Following institutional ethical committee approval and obtaining informed written consent, 100 patients of American Society of Anesthesiologists (ASA) grades I and II in the age group of 18-45 years of either sex undergoing elective surgeries under general anaesthesia were included in the study. The patients were randomly allocated into two groups of 50 patients each. Group Mc - laryngoscopy was performed using a no. 3 McCoy blade. Group Ml - laryngoscopy was performed using a no. 2 Miller blade. The laryngoscopic view was compared using Cormack and Lehane grading. Haemodynamic parameters before, during, and after laryngoscopy were recorded.
RESULTS


Hemodynamic parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were increased in both the groups but were statistically and clinically significant in the Miller group with p≤0.001.
CONCLUSION


McCoy blade is associated with a significantly more stable hemodynamic response to laryngoscopy in comparison with the Miller blade.",2022,McCoy blade is associated with a significantly more stable hemodynamic response to laryngoscopy in comparison with the Miller blade.,['100 patients of American Society of Anesthesiologists (ASA) grades I and II in the age group of 18-45 years of either sex undergoing elective surgeries under general anaesthesia were included in the study'],"['McCoy blade', 'Laryngoscopy']","['overall laryngeal movement', 'stable hemodynamic response', 'heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.00879418,McCoy blade is associated with a significantly more stable hemodynamic response to laryngoscopy in comparison with the Miller blade.,"[{'ForeName': 'Thejeswini', 'Initials': 'T', 'LastName': 'Mahadevaiah', 'Affiliation': 'Department of Anaesthesiology, Mathikere Sampangi Ramaiah Medical College, Bangalore, IND.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'T S', 'Affiliation': 'Department of Emergency Medicine, Mathikere Sampangi Ramaiah Medical College, Bangalore, IND.'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Rani', 'Affiliation': 'Department of Anaesthesiology, Mathikere Sampangi Ramaiah Medical College, Bangalore, IND.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'K N', 'Affiliation': 'Department of Anaesthesiology, Mathikere Sampangi Ramaiah Medical College, Bangalore, IND.'}, {'ForeName': 'Shwetha', 'Initials': 'S', 'LastName': 'G M', 'Affiliation': 'Department of Anaesthesiology, North Bangalore Hospital, Bangalore, IND.'}]",Cureus,['10.7759/cureus.24914']
1829,35698974,Unblinded and Blinded N-of-1 Trials Versus Usual Care: A Randomized Controlled Trial to Increase Statin Uptake in Primary Care.,"BACKGROUND


The aim was to assess whether an intervention incorporating a practicable open-label n-of-1 trial would lead to greater uptake of statin than usual care and comparable uptake to a closed-label gold-standard n-of-1 trial.
METHODS


We enrolled patients who had stopped or declined statins into a 3-arm trial (usual care, unblinded, and blinded n-of-1 intervention arms). Physicians advised participants randomized to usual care to take statin therapy to prevent cardiovascular disease. In both intervention arms, physicians delivered a theoretically informed informed intervention endorsing the value of experimenting with medication in n-of-1 trials to assess whether it caused side-effects. In these trials, participants alternated between 4 weeks of medication and no medication (unblinded arm) or randomly sorted active and placebo (blinded arm) and recorded symptoms and symptom attributions for 6 months. Thereafter, physicians discussed participants' symptom reports during active/inactive treatment periods and asked participants to resume statins if appropriate.
RESULTS


Seventy-three were randomized to the intervention arms and 20 to the control group. Fifty-six of 73 (77%) attempted the n-of-1 experiment; 28/36 (78%) in the unblinded arm; and 28/37 (76%) in the blinded arm. Forty-three of 56 (77%) completed the 6-month experiment and received feedback from the physician; 20/28 (71%) in the unblinded arm and 23/28 (82%) in the blinded arm. Thirty-three of 76 (45%) people restarted statins in the n-of-1 arms compared with 4/20 (20%) in the control arm, difference 24% (95% CI, 5%-43%;  P =0.041). There was no evidence this differed between blinded and unblinded arms, difference 2% (95% CI, -20% to 24%;  P =0.86). Adverse events occurred at a similar rate on and off statin.
CONCLUSIONS


In patients refusing or intolerant of statin, supporting experimentation with n-of-1 trials increases medication uptake compared with usual care. Alternating on-off medication in unblinded n-of-1 experiments appears as effective as a blinded experiment.
REGISTRATION


URL: https://doi.org/10.1186/ISRCTN11142694; Unique identifier: ISRCTN11142694.",2022,"There was no evidence this differed between blinded and unblinded arms, difference 2% (95% CI, -20% to 24%;  P =0.86).","['Primary Care', 'enrolled patients who had stopped or declined statins into a 3-arm trial (usual care, unblinded, and blinded n-of-1 intervention arms', 'Seventy-three were randomized to the intervention arms and 20 to the control group']","['usual care to take statin therapy', 'Usual Care', 'randomly sorted active and placebo']","['medication uptake', 'Adverse events', 'people restarted statins']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]",73.0,0.308584,"There was no evidence this differed between blinded and unblinded arms, difference 2% (95% CI, -20% to 24%;  P =0.86).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Tudor', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, United Kingdom. (K.T., J.B., P.A.).'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, United Kingdom. (K.T., J.B., P.A.).'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Howick', 'Affiliation': 'Faculty of Philosophy, University of Oxford, Radcliffe Observatory Quarter, United Kingdom. (J.H.).'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Fox', 'Affiliation': 'Bicester Health Centre, Coker Close, Bicester, United Kingdom (R.F.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, United Kingdom. (K.T., J.B., P.A.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.007793']
1830,35698933,Implementation of an Integrated Care Model for Frequent-Exacerbator COPD Patients: A Controlled Prospective Study.,"INTRODUCTION


Frequent-exacerbator COPD (fe-COPD) associated with frequent hospital admissions have high morbidity, mortality and use of health resources. These patients should be managed in personalized integrated care models (ICM). Accordingly, we aimed to evaluate the long-term effectiveness of a fe-COPD ICM on emergency room (ER) visits, hospital admissions, days of hospitalization, mortality and improvement of health status.
METHODS


Prospective-controlled study with analysis of a cohort of fe-COPD patients assigned to ICM and followed-up for maximally 7 years that were compared to a parallel cohort who received standard care. All patients had a confirmed diagnosis of COPD with a history of ≥2 hospital admissions due to exacerbations in the year before enrollment. The change in CAT score and mMRC dyspnea scale, hospital admissions, ER visits, days of hospitalization, and mortality were analyzed.
RESULTS


141 patients included in the ICM were compared to 132 patients who received standard care. The ICM reduced hospitalizations by 38.2% and ER visits by 69.7%, with reduction of hospitalizations for COPD exacerbation, ER visits and days of hospitalization (p<0.05) compared to standard care. Further, health status improved among the ICM group after 1 year of follow-up (p=0.001), effect sustained over 3 years. However, mortality was not different between groups (p=0.117). Last follow-up CAT score>17 was the strongest independent risk factor for mortality and hospitalization among ICM patients.
CONCLUSIONS


An ICM for fe-COPD patients effectively decreases ER and hospital admissions and improves health status, but not mortality.",2021,"The ICM reduced hospitalizations by 38.2% and ER visits by 69.7%, with reduction of hospitalizations for COPD exacerbation, ER visits and days of hospitalization (p<0.05) compared to standard care.","['Prospective-controlled study with analysis of a cohort of fe-COPD patients assigned to', 'Frequent-Exacerbator COPD Patients', '141 patients included in the ICM were compared to 132 patients who received standard care', 'All patients had a confirmed diagnosis of COPD with a history of ≥2 hospital admissions due to exacerbations in the year before enrollment']","['ICM', 'fe-COPD ICM']","['hospitalizations for COPD exacerbation, ER visits and days of hospitalization', 'health status', 'ICM reduced hospitalizations', 'ER and hospital admissions and improves health status', 'ER) visits, hospital admissions, days of hospitalization, mortality and improvement of health status', 'CAT score and mMRC dyspnea scale, hospital admissions, ER visits, days of hospitalization, and mortality', 'mortality']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",141.0,0.0363534,"The ICM reduced hospitalizations by 38.2% and ER visits by 69.7%, with reduction of hospitalizations for COPD exacerbation, ER visits and days of hospitalization (p<0.05) compared to standard care.","[{'ForeName': 'Borja G', 'Initials': 'BG', 'LastName': 'Cosío', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Spain; CIBERES, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: borja.cosio@ssib.es.'}, {'ForeName': 'Hanaa', 'Initials': 'H', 'LastName': 'Shafiek', 'Affiliation': 'Chest Diseases Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Verdú', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Spain.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Valera', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Spain; CIBERES, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Martínez', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Spain.'}, {'ForeName': 'Lluisa', 'Initials': 'L', 'LastName': 'Ramón', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Toledo-Pons', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Spain.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Sala', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Spain; CIBERES, Instituto de Salud Carlos III, Madrid, Spain.'}]",Archivos de bronconeumologia,['10.1016/j.arbr.2021.01.010']
1831,35700932,Seriously ill patients' prioritized goals and their clinicians' perceptions of those goals.,"CONTEXT


Seriously ill patients whose prioritized healthcare goals are understood by their clinicians are likely better positioned to receive goal-concordant care.
OBJECTIVES


To examine the proportion of seriously ill patients whose prioritized healthcare goal is accurately perceived by their clinician and identify factors associated with accurate perception.
METHODS


Secondary analysis of a multicenter cluster-randomized trial of outpatients with serious illness and their clinicians. Approximately two weeks after a clinic visit, patients reported their current prioritized healthcare goal - extending life over relief of pain and discomfort, or relief of pain and discomfort over extending life - and clinicians reported their perception of their patients' current prioritized healthcare goal; matching these items defined accurate perception.
RESULTS


Of 252 patients with a prioritized healthcare goal, 60% had their goal accurately perceived by their clinician, 27% were cared for by clinicians who perceived prioritization of the alternative goal, and 13% had their clinician answer unsure. Patients who were older (OR 1.03 per year; 95%CI 1.01, 1.05), had stable goals (OR 2.52; 95%CI 1.26, 5.05), and had a recent goals-of-care discussion (OR 1.78, 95%CI 1.00, 3.16) were more likely to have their goals accurately perceived.
CONCLUSION


A majority of seriously ill outpatients are cared for by clinicians who accurately perceive their patients' prioritized healthcare goals. However, a substantial portion are not and may be at higher risk for goal-discordant care. Interventions that facilitate goals-of-care discussions may help align care with goals, as recent discussions were associated with accurate perceptions of patients' prioritized goals.",2022,"Patients who were older (OR 1.03 per year; 95%CI 1.01, 1.05), had stable goals (OR 2.52; 95%CI 1.26, 5.05), and had a recent goals-of-care discussion (OR 1.78, 95%CI 1.00, 3.16) were more likely to have their goals accurately perceived.
","['outpatients with serious illness and their clinicians', 'Patients who were older (OR 1.03 per year; 95%CI 1.01, 1.05), had stable goals (OR 2.52; 95%CI 1.26, 5.05), and had a recent goals-of-care discussion (OR 1.78, 95%CI 1.00, 3.16) were more likely to have their goals accurately perceived', '252 patients with a prioritized healthcare goal']",[],"['pain and discomfort, or relief of pain and discomfort']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C4068754', 'cui_str': '1.05'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4517632', 'cui_str': '2.52'}, {'cui': 'C4517498', 'cui_str': '1.26'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",252.0,0.0993084,"Patients who were older (OR 1.03 per year; 95%CI 1.01, 1.05), had stable goals (OR 2.52; 95%CI 1.26, 5.05), and had a recent goals-of-care discussion (OR 1.78, 95%CI 1.00, 3.16) were more likely to have their goals accurately perceived.
","[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Modes', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: matthew.modes@cshs.org.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Engelberg', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Nielsen', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington.'}, {'ForeName': 'Lyndia C', 'Initials': 'LC', 'LastName': 'Brumback', 'Affiliation': 'Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington; Department of Biostatistics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Thanh H', 'Initials': 'TH', 'LastName': 'Neville', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Walling', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, University of California Los Angeles, Los Angeles, California; Center for the Study of Healthcare Innovation, Implementation and Policy, Veterans Affairs Greater Los Angeles Health Care System, Los Angeles, California.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington; Department of Bioethics and Humanities, University of Washington, Seattle, Washington.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Kross', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2022.06.004']
1832,35700926,Efficacy of the mHealth application in patients with type 2 diabetes transitioning from inpatient to outpatient care: a randomized controlled clinical trial.,"INTRODUCTION


No studies have assessed the efficacy of telemedicine using a platform for recording and adjusting insulin doses in patients with diabetes mellitus type 2 (DM2) transitioning from inpatient to outpatient care. This study aimed to assess, in a population of patients with DM2, discharged from a tertiary referral hospital, whether treatment based on the use of an mHealth application was associated with better glycemic control at the 3-month follow-up, than standard care.
METHODS


This open, randomized, controlled clinical trial included adult DM2 patients who were transitioning from inpatient to outpatient care. The efficacy and safety of patient management with and without mHealth was compared at the 3-month follow-up. The primary outcome was the change in the Glycosylated hemoglobin (HbA1c) levels. The secondary outcomes were the rates of hypoglycemic and hyperglycemic events and treatment satisfaction measured using the Insulin Treatment Satisfaction Questionnaire (ITSQ).
RESULTS


In total, 86 patients (41 using mHealth) were included in the clinical trial. HbA1c levels showed a significant decrease in both groups. The mean HbA1c level was significantly lower in the mHealth group. Patients using mHealth showed decreased incidence rate ratios of hypoglycemia 3.0 mmol/L [<54 mg/dl], hypoglycemia ranging from 3.0 to 3.8 mmol/L [54 to 70 mg/dl] and severe hypoglycemia. The level of satisfaction assessed using the ITSQ was higher in the mHealth group.
CONCLUSION


Using mHealth in patients with DM2 transitioning from inpatient to outpatient care improves metabolic control and may reduce the hypoglycemia rates.",2022,No studies have assessed the efficacy of telemedicine using a platform for recording and adjusting insulin doses in patients with diabetes mellitus type 2 (DM2) transitioning from inpatient to outpatient care.,"['adult DM2 patients who were transitioning from inpatient to outpatient care', 'patients with DM2, discharged from a tertiary referral hospital, whether treatment based on the use of an mHealth application was associated with better glycemic control at the 3-month follow-up, than standard care', 'patients with DM2 transitioning from inpatient to outpatient care', 'patients with type 2 diabetes transitioning from inpatient to outpatient care', '86 patients (41 using mHealth) were included in the clinical trial', 'patients with diabetes mellitus type 2 (DM2) transitioning from inpatient to outpatient care']","['telemedicine', 'mHealth application']","['severe hypoglycemia', 'hypoglycemia', 'HbA1c levels', 'level of satisfaction assessed using the ITSQ', 'efficacy and safety', 'incidence rate ratios of hypoglycemia', 'hypoglycemia rates', 'mean HbA1c level', 'rates of hypoglycemic and hyperglycemic events and treatment satisfaction measured using the Insulin Treatment Satisfaction Questionnaire (ITSQ', 'Glycosylated hemoglobin (HbA1c) levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",86.0,0.0417741,No studies have assessed the efficacy of telemedicine using a platform for recording and adjusting insulin doses in patients with diabetes mellitus type 2 (DM2) transitioning from inpatient to outpatient care.,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'María Gómez', 'Affiliation': 'Chief of the Endocrinology Unit, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Carrera 7 No. 40-62, Bogotá, Colombia. Electronic address: amgomezm5@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Cristina Henao', 'Affiliation': 'Endocrinology Unit, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Carrera 7 No. 40-62, Bogotá, Colombia. Electronic address: fucshenao@hotmail.com.'}, {'ForeName': 'Fabián', 'Initials': 'F', 'LastName': 'León Vargas', 'Affiliation': 'Universidad Antonio Nariño, Calle 22S No. 12D-81, Bogotá, Colombia. Electronic address: fabianleon@uan.edu.co.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Mauricio Muñoz', 'Affiliation': 'Internal Medicine Department, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Carrera 7 No. 40-62, Bogotá, Colombia. Electronic address: o.munoz@javeriana.edu.co.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'David Lucero', 'Affiliation': 'Endocrinology Unit, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Carrera 7 No. 40-62, Bogotá, Colombia. Electronic address: odlucero@husi.org.co.'}, {'ForeName': 'Maira', 'Initials': 'M', 'LastName': 'García Jaramillo', 'Affiliation': 'Universidad EAN, Calle 79 No. 11-45, Bogotá, Colombia. Electronic address: magarcia@universidadean.edu.co.'}, {'ForeName': 'Arantza', 'Initials': 'A', 'LastName': 'Aldea', 'Affiliation': 'Oxford Brookes University, Wheatley Campus, Oxford OX33 1HX, United Kingdom. Electronic address: aaldea@brookes.ac.uk.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'Oxford Brookes University, Wheatley Campus, Oxford OX33 1HX, United Kingdom. Electronic address: cemartin@brookes.ac.uk.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Miguel Rodríguez Hortúa', 'Affiliation': 'Pontificia Universidad Javeriana, Carrera 7 No. 40-62, Bogotá, Colombia. Electronic address: ro.luis@javeriana.edu.co.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Patricia Rubio Reyes', 'Affiliation': 'Endocrinology Unit, Hospital Universitario San Ignacio, Carrera 7 No. 40-62, Bogotá, Colombia. Electronic address: cprubio@husi.org.co.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Alejandra Páez Hortúa', 'Affiliation': 'Pontificia Universidad Javeriana, Carrera 7 No. 40-62, Bogotá, Colombia. Electronic address: Ma.paez@javeriana.edu.co.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Rondón', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Carrera 7 No. 40-62, Bogotá, Colombia. Electronic address: martin.rondon@javeriana.edu.co.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Maria Gómez', 'Affiliation': 'Chief of the Endocrinology Unit, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Carrera 7 No. 40-62, Bogotá, Colombia. Electronic address: amgomezm5@gmail.com.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2022.109948']
1833,35700915,Effect of cerebellum stimulation on cognitive recovery in patients with Alzheimer disease: A randomized clinical trial.,"INTRODUCTION


Evidence indicates that the cerebellum is involved in cognitive processing. However, the specific mechanisms through which the cerebellum repetitive transcranial magnetic stimulation (rTMS) contributes to the cognitive state are unclear.
METHODS


In the current randomized, double-blind, sham-controlled trial, 27 patients with Alzheimer's disease (AD) were randomly allotted to one of the two groups: rTMS-real or rTMS-sham. We investigated the efficacy of a four-week treatment of bilateral cerebellum rTMS to promote cognitive recovery and alter specific cerebello-cerebral functional connectivity.
RESULTS


The cerebellum rTMS significantly improves multi-domain cognitive functions, directly associated with the observed intrinsic functional connectivity between the cerebellum nodes and the dorsolateral prefrontal cortex (DLPFC), medial frontal cortex, and the cingulate cortex in the real rTMS group. In contrast, the sham stimulation showed no significant impact on the clinical improvements and the cerebello-cerebral connectivity.
CONCLUSION


Our results depict that 5 Hz rTMS of the bilateral cerebellum is a promising, non-invasive treatment of cognitive dysfunction in AD patients. This cognitive improvement is accompanied by brain connectivity modulation and is consistent with the pathophysiological brain disconnection model in AD patients.",2022,"The cerebellum rTMS significantly improves multi-domain cognitive functions, directly associated with the observed intrinsic functional connectivity between the cerebellum nodes and the dorsolateral prefrontal cortex (DLPFC), medial frontal cortex, and the cingulate cortex in the real rTMS group.","['patients with Alzheimer disease', 'AD patients', ""27 patients with Alzheimer's disease (AD""]","['rTMS-real or rTMS-sham', 'bilateral cerebellum rTMS', 'cerebellum repetitive transcranial magnetic stimulation (rTMS', 'cerebellum stimulation']","['dorsolateral prefrontal cortex (DLPFC), medial frontal cortex, and the cingulate cortex', 'cognitive recovery', 'multi-domain cognitive functions', 'clinical improvements and the cerebello-cerebral connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0598179', 'cui_str': 'Cingulate Cortex'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",27.0,0.289661,"The cerebellum rTMS significantly improves multi-domain cognitive functions, directly associated with the observed intrinsic functional connectivity between the cerebellum nodes and the dorsolateral prefrontal cortex (DLPFC), medial frontal cortex, and the cingulate cortex in the real rTMS group.","[{'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': 'Department of Neurology, Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Electronic address: 15951753160@163.com.'}, {'ForeName': 'Fanyu', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Bengbu, Bengbu, Anhui, 233000, China. Electronic address: 759713786@qq.com.""}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Electronic address: wayiyi320@163.com.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Electronic address: yanyixin96@163.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Electronic address: donglin1996@outlook.com.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Electronic address: 1664955736@qq.com.'}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurology, Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Electronic address: 1421377719@qq.com.'}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'Department of Neurology, Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Electronic address: nydttmj@163.com.'}, {'ForeName': 'Xingjian', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Electronic address: linxingjian@njmu.cn.'}, {'ForeName': 'Jingping', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Electronic address: profshijp@163.com.'}]",Brain stimulation,['10.1016/j.brs.2022.06.004']
1834,35701314,The impact of a comprehensive pharmaceutical care intervention in addition to cardiac rehabilitation program on outcomes of post-acute coronary syndrome patients: A pilot study.,"OBJECTIVE


To test the efficacy of Comprehensive pharmaceutical care intervention added to cardiac rehabilitation program(CR programs) in improving echocardiographic parameters, nutritional status and High sensitivity C-Reactive Protein(hs-CRP), in post-acute coronary syndrome patients.
METHODS


A prospective; randomized, controlled study. 40 post-acute coronary syndrome patients, participating in CR program, were randomly allocated to either the control group(n = 20) or the intervention group(n = 20). Pharmaceutical care intervention included face-to-face education about the disease, healthy lifestyle, medication adherence, drug related problems management and goal setting. hs-CRP and cardiac parameters were measured at baseline and after 3 months.
RESULTS


After three months,the intervention group showed a significant decrease in left ventricular end systolic volume (p = 0.0026) and left ventricular end diastolic volume (p = 0.0009) compared to the control group. Also, intervention group showed a significant increase in nutritional status (p = 0.037) and the patients' knowledge about the disease and drugs (p = 0.0001). However, there was no significant change in hscrp level between groups.
CONCLUSION


Our findings indicate that Comprehensive pharmaceutical care intervention added to CR programs significantly improved cardiac parameters and nutritional status. This is best explained by increasing adherence to cardiovascular medications and to healthier lifestyle and optimizing medication knowledge and doses.
PRACTICE IMPLICATIONS


Implementing Comprehensive pharmaceutical care intervention added to CR programs could improve the cardiac function and nutritional status of post-acute coronary syndrome patients.",2022,"After three months,the intervention group showed a significant decrease in left ventricular end systolic volume (p = 0.0026) and left ventricular end diastolic volume (p = 0.0009) compared to the control group.","['40 post-acute coronary syndrome patients, participating in CR program', 'post-acute coronary syndrome patients']","['Comprehensive pharmaceutical care intervention added to cardiac rehabilitation program(CR programs', 'comprehensive pharmaceutical care intervention', 'cardiac rehabilitation program']","['cardiac function and nutritional status', 'nutritional status', 'left ventricular end systolic volume', 'hscrp level', 'left ventricular end diastolic volume', 'cardiac parameters and nutritional status', 'hs-CRP and cardiac parameters']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",40.0,0.00438836,"After three months,the intervention group showed a significant decrease in left ventricular end systolic volume (p = 0.0026) and left ventricular end diastolic volume (p = 0.0009) compared to the control group.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ahmed Casper', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain-Shams University, Cairo, Egypt. Electronic address: Eman.casper@pharma.asu.edu.eg.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mohmed El Wakeel', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain-Shams University, Cairo, Egypt. Electronic address: lamia.elwakeel@pharma.asu.edu.eg.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ayman Saleh', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Ain-Shams University, Cairo, Egypt. Electronic address: maymanmsaleh@yahoo.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hamed El-Hamamsy', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain-Shams University, Cairo, Egypt. Electronic address: m_elhamamsy@hotmail.com.'}]",Patient education and counseling,['10.1016/j.pec.2022.06.004']
1835,35701242,Effect of a Posture-Cueing Shirt on Sitting Posture During a Functional Task in Healthy Participants: A Randomized Cross-Over Study.,"OBJECTIVES


The purpose of this study was to investigate the effect of a posture-cueing shirt on sitting posture during a functional task.
METHODS


Thirty healthy male participants were seated at a standardized workstation while completing 3 laptop writing tasks of 15-minute duration wearing either a posture-cueing shirt, a compression shirt, or no shirt. Posture was assessed based on photos taken at minutes 1 and 15 into the writing task from which the head and shoulder angles were measured and extracted for analysis. After each task, participants rated any potential pain they felt during the task on an 11-point numeric rating scale (NRS).
RESULTS


The results showed that none of the shirts significantly affected the head or shoulder angles at any time point. Participants reported lower pain levels after using the posture-cueing shirt (NRS 0 [0-1]) compared with no shirt (NRS 1 [0-2]; P = .012). No significant difference in pain levels was observed between shirts.
CONCLUSION


Although posture did not change in any conditions for these healthy male subjects, the posture-cueing shirt resulted in a lower pain intensity compared with no shirt but not with a compression shirt. Although a significant difference was found for pain intensity favoring the posture-cueing shirt, this difference was negligible, and thus its value to reduce pain or improve posture in healthy subjects remains in question.",2022,"Although a significant difference was found for pain intensity favoring the posture-cueing shirt, this difference was negligible, and thus its value to reduce pain or improve posture in healthy subjects remains in question.","['healthy male subjects', 'Healthy Participants', 'Thirty healthy male participants', 'healthy subjects']","['Posture-Cueing Shirt on Sitting Posture', 'standardized workstation while completing 3 laptop writing tasks of 15-minute duration wearing either a posture-cueing shirt, a compression shirt, or no shirt', 'posture-cueing shirt']","['pain intensity', 'sitting posture', 'head or shoulder angles', 'lower pain levels', '11-point numeric rating scale (NRS', 'pain levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0453917', 'cui_str': 'Shirt'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1737642', 'cui_str': 'Laptop computer'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",30.0,0.0787734,"Although a significant difference was found for pain intensity favoring the posture-cueing shirt, this difference was negligible, and thus its value to reduce pain or improve posture in healthy subjects remains in question.","[{'ForeName': 'Steffan W M', 'Initials': 'SWM', 'LastName': 'Christensen', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg, Denmark; Department of Physiotherapy, University College of Northern Denmark, Aalborg, Denmark. Electronic address: stc@hst.aau.dk.'}, {'ForeName': 'Steffen S', 'Initials': 'SS', 'LastName': 'Johansson', 'Affiliation': 'Department of Physiotherapy, University College of Northern Denmark, Aalborg, Denmark.'}, {'ForeName': 'Mikkel D', 'Initials': 'MD', 'LastName': 'Jensen', 'Affiliation': 'Department of Physiotherapy, University College of Northern Denmark, Aalborg, Denmark.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Jensen', 'Affiliation': 'Department of Physiotherapy, University College of Northern Denmark, Aalborg, Denmark.'}, {'ForeName': 'Trine H', 'Initials': 'TH', 'LastName': 'Knudsen', 'Affiliation': 'Department of Physiotherapy, University College of Northern Denmark, Aalborg, Denmark.'}, {'ForeName': 'Thorvaldur S', 'Initials': 'TS', 'LastName': 'Palsson', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg, Denmark; Department of Physiotherapy and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2022.03.003']
1836,35701233,Effectiveness and safety of acupuncture for overactive bladder: a randomised controlled trial (abridged secondary publication).,,2022,,['overactive bladder'],['acupuncture'],['Effectiveness and safety'],"[{'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.25385,,"[{'ForeName': 'Z X', 'Initials': 'ZX', 'LastName': 'Lin', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'N H T', 'Initials': 'NHT', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Geriatrics, Tuen Mun Hospital.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Kwan', 'Affiliation': 'Department of Medicine and Geriatrics, Tuen Mun Hospital.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Chan', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'K Y S', 'Initials': 'KYS', 'LastName': 'Tam', 'Affiliation': 'Yan Oi Tong - The Chinese University of Hong Kong Chinese Medicine Centre for Training and Research.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
1837,35701232,Electrocoagulation versus gelantine-thrombin matrix sealant for haemostasis after laparoscopic surgery of ovarian endometriomas: a randomised control trial (abridged secondary publication).,,2022,,['haemostasis after laparoscopic surgery of ovarian endometriomas'],['Electrocoagulation versus gelantine-thrombin matrix sealant'],[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}]","[{'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}]",[],,0.257312,,"[{'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Chung', 'Affiliation': 'The Department of Obstetrics and Gynaecology, Prince of Wales Hospital.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Li', 'Affiliation': 'The Department of Obstetrics and Gynaecology, Prince of Wales Hospital.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
1838,35701134,[Effect of artificial liver with double plasma molecular absorb system model on patients' platelets and corresponding treatment strategy].,"OBJECTIVE


To compare the effects of artificial liver treatment with double plasma molecular adsorption system(DPMAS) mode and traditional plasma exchange (PE) mode on platelets in patients, and to evaluate the clinical efficacy of recombinent human thrombopoietin (rhTPO) in the treatment of thrombocytopenia.
METHODS


A total of fifteen patients undergoing artificial liver with DPMAS model admitted to the Fifth Affiliated Hospital of Guangzhou Medical University from January 2018 to November 2020 were selected and included in the DPMAS group, and another 15 patients receiving PE were selected and included in the PE group. The improvement of clinical symptoms, such as fatigue, jaundice, oliguria, edema, etc. before and after artificial liver treatment was compared between the two groups, and the trend of blood routine (especially platelet), coagulation function and other indexes before and after treatment were compared between the two groups. The use of rhTPO and the number of platelets were recorded during treatment.
RESULTS


The improvement rate of clinical symptoms in DPMAS group was 86.67%, which was higher than that in PE group, but the difference was not statistically significant ( P >0.05). There was no statistical significance in the outcome of the two groups within 90 days ( P >0.05). There was no significant difference in white blood cell (WBC) and hemoglobin (HB) between the two groups after treatment ( P >0.05). However, the level of platelet(PLT) in DPMAS group was significantly lower than that before treatment ( P  < 0.05), and was significantly lower than that in PE group ( P  < 0.05). After treatment, the international normalized ratio (INR) level in PE group was significantly improved ( P  < 0.05), but there was no significant difference in the INR level in DPMAS group ( P >0.05). The patients in the DPMAS group received an average of (8.2±3.1) doses of rhTPO and (1.5±0.3) IU of platelet transfusions during hospitalization. In DMPAS group, platelets increased significantly after infusion of terbium.
CONCLUSION


Compared with PE mode, the artificial liver with DPMAS mode can reduce platelet levels in patients, but the application of rhTPO can stimulate platelet regeneration and increase platelet levels in the patients, thereby reducing the risk of bleeding due to platelet hypoplasia.",2022,There was no significant difference in white blood cell (WBC) and hemoglobin (HB) between the two groups after treatment ( P >0.05).,"[""patients' platelets and corresponding treatment strategy"", 'fifteen patients undergoing artificial liver with DPMAS model admitted to the Fifth Affiliated Hospital of Guangzhou Medical University from January 2018 to November 2020 were selected and included in the DPMAS group, and another 15 patients receiving PE were selected and included in the PE group']","['DMPAS', 'recombinent human thrombopoietin (rhTPO', 'DPMAS', 'artificial liver treatment with double plasma molecular adsorption system(DPMAS', 'artificial liver with double plasma molecular absorb system model', 'rhTPO']","['international normalized ratio (INR) level', 'platelet levels', 'clinical symptoms, such as fatigue, jaundice, oliguria, edema, etc', 'INR level', 'improvement rate of clinical symptoms', 'blood routine (especially platelet), coagulation function', 'white blood cell (WBC) and hemoglobin (HB', 'level of platelet(PLT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0336562', 'cui_str': 'Artificial liver'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001674', 'cui_str': 'Adsorption'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001674', 'cui_str': 'Adsorption'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0336562', 'cui_str': 'Artificial liver'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0028961', 'cui_str': 'Oliguria'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",15.0,0.0520263,There was no significant difference in white blood cell (WBC) and hemoglobin (HB) between the two groups after treatment ( P >0.05).,"[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Jia', 'Affiliation': 'Department of Gastroenterology, the Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou 510700, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Department of Gastroenterology, the Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou 510700, China.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, the Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou 510700, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, the Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou 510700, China.'}, {'ForeName': 'P Q', 'Initials': 'PQ', 'LastName': 'Han', 'Affiliation': 'Department of Gastroenterology, the Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou 510700, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
1839,35701109,Postconcussion discharge advice does not improve concussion knowledge in a community sample.,"OBJECTIVE


Poor concussion knowledge in the community has been linked to reduced injury identification. This study investigated if concussion knowledge could be improved by providing standard postinjury advice (written brochure).
METHODS


This study was a prospective, controlled study, with random allocation of 199 Australian adults to receive either a concussion information (CI, n=101), or non-CI (n=98). All participants completed the Rosenbaum Concussion Knowledge and Attitudes Survey on three occasions: pre-education and posteducation, and 1 week later.
RESULTS


A 2 (condition) × 3 (occasion) mixed analysis of variance with concussion knowledge as the dependent variable did not find a statistically significant interaction (p>0.05). This result was unchanged: (1) with the covariate addition of background education and; (2) in a subgroup analysis (individuals with initially 'low' self-rated knowledge). Some key misconceptions about concussion were identified.
CONCLUSION


The community knowledge of concussion was not significantly improved by the concussion advice. Since injury recognition relies ton an extent on community knowledge, the identified misconceptions should be addressed. This could occur via public health messaging. In clinical settings and for future research, the next steps should also include regular updating of concussion information to keep pace with advances in the field.",2022,The community knowledge of concussion was not significantly improved by the concussion advice.,"['199 Australian adults to receive either a concussion information (CI, n=101), or non-CI (n=98']",[],['concussion knowledge'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}]",[],"[{'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",199.0,0.0745817,The community knowledge of concussion was not significantly improved by the concussion advice.,"[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sullivan', 'Affiliation': 'School of Psychology and Counselling, Faculty of Health, Queensland University of Technology, Kelvin Grove, Queensland, Australia karen.sullivan@qut.edu.au.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kinmond', 'Affiliation': 'School of Psychology and Counselling, Faculty of Health, Queensland University of Technology, Kelvin Grove, Queensland, Australia.'}, {'ForeName': 'Kannan', 'Initials': 'K', 'LastName': 'Singaravelu Jaganathan', 'Affiliation': 'School of Psychology and Counselling, Faculty of Health, Queensland University of Technology, Kelvin Grove, Queensland, Australia.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2022-044593']
1840,35701094,Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis.,"OBJECTIVE


Lumen-apposing metal stents (LAMS) are believed to clinically improve endoscopic transluminal drainage of infected necrosis when compared with double-pigtail plastic stents. However, comparative data from prospective studies are very limited.
DESIGN


Patients with infected necrotising pancreatitis, who underwent an endoscopic step-up approach with LAMS within a multicentre prospective cohort study were compared with the data of 51 patients in the randomised TENSION trial who had been assigned to the endoscopic step-up approach with double-pigtail plastic stents. The clinical study protocol was otherwise identical for both groups. Primary end point was the need for endoscopic transluminal necrosectomy. Secondary end points included mortality, major complications, hospital stay and healthcare costs.
RESULTS


A total of 53 patients were treated with LAMS in 16 hospitals during 27 months. The need for endoscopic transluminal necrosectomy was 64% (n=34) and was not different from the previous trial using plastic stents (53%, n=27)), also after correction for baseline characteristics (OR 1.21 (95% CI 0.45 to 3.23)). Secondary end points did not differ between groups either, which also included bleeding requiring intervention-5 patients (9%) after LAMS placement vs 11 patients (22%) after placement of plastic stents (relative risk 0.44; 95% CI 0.16 to 1.17). Total healthcare costs were also comparable (mean difference -€6348, bias-corrected and accelerated 95% CI -€26 386 to €10 121).
CONCLUSION


Our comparison of two patient groups from two multicentre prospective studies with a similar design suggests that LAMS do not reduce the need for endoscopic transluminal necrosectomy when compared with double-pigtail plastic stents in patients with infected necrotising pancreatitis. Also, the rate of bleeding complications was comparable.",2022,"The need for endoscopic transluminal necrosectomy was 64% (n=34) and was not different from the previous trial using plastic stents (53%, n=27)), also after correction for baseline characteristics (OR 1.21 (95% CI 0.45 to 3.23)).","['infected necrotising pancreatitis', 'patients with infected necrotising pancreatitis', '53 patients', 'Patients with infected necrotising pancreatitis, who underwent an']","['Lumen-apposing metal stents (LAMS', 'endoscopic step-up approach with LAMS', 'endoscopic step-up approach with double-pigtail plastic stents', 'LAMS', 'lumen-apposing metal stents versus double-pigtail plastic stents']","['mortality, major complications, hospital stay and healthcare costs', 'rate of bleeding complications', 'endoscopic transluminal necrosectomy', 'need for endoscopic transluminal necrosectomy', 'Total healthcare costs']","[{'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0441290', 'cui_str': 'Metal stent'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0522520', 'cui_str': 'Transluminal approach'}, {'cui': 'C4761057', 'cui_str': 'Necrosectomy'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",53.0,0.166671,"The need for endoscopic transluminal necrosectomy was 64% (n=34) and was not different from the previous trial using plastic stents (53%, n=27)), also after correction for baseline characteristics (OR 1.21 (95% CI 0.45 to 3.23)).","[{'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Boxhoorn', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Verdonk', 'Affiliation': 'Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Boermeester', 'Affiliation': 'Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Bollen', 'Affiliation': 'Department of Radiology, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Stefan Aw', 'Initials': 'SA', 'LastName': 'Bouwense', 'Affiliation': 'Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Cappendijk', 'Affiliation': ""Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'Wouter L', 'Initials': 'WL', 'LastName': 'Curvers', 'Affiliation': 'Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'Dejong', 'Affiliation': 'Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Sven M', 'Initials': 'SM', 'LastName': 'van Dijk', 'Affiliation': 'Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.'}, {'ForeName': 'Hendrik M', 'Initials': 'HM', 'LastName': 'van Dullemen', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Casper Hj', 'Initials': 'CH', 'LastName': 'van Eijck', 'Affiliation': 'Department of Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Erwin Jm', 'Initials': 'EJ', 'LastName': 'van Geenen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Hadithi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Wouter L', 'Initials': 'WL', 'LastName': 'Hazen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Honkoop', 'Affiliation': 'Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Jeanin E', 'Initials': 'JE', 'LastName': 'van Hooft', 'Affiliation': 'Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maarten Ajm', 'Initials': 'MA', 'LastName': 'Jacobs', 'Affiliation': 'Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.'}, {'ForeName': 'June Ec', 'Initials': 'JE', 'LastName': 'Kievits', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marnix Pm', 'Initials': 'MP', 'LastName': 'Kop', 'Affiliation': 'Department of Radiology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kouw', 'Affiliation': 'Department of Gastroenterology and Hepatology, Gelre Hospital, Apeldoorn, The Netherlands.'}, {'ForeName': 'Sjoerd D', 'Initials': 'SD', 'LastName': 'Kuiken', 'Affiliation': 'Department of Gastroenterology and Hepatology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Ledeboer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Vincent B', 'Initials': 'VB', 'LastName': 'Nieuwenhuijs', 'Affiliation': 'Department of Surgery, Isala Clinics, Zwolle, The Netherlands.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'Perk', 'Affiliation': 'Department of Gastroenterology, Haaglanden Medical Center, Den Haag, The Netherlands.'}, {'ForeName': 'Jan-Werner', 'Initials': 'JW', 'LastName': 'Poley', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Quispel', 'Affiliation': 'Department of Gastroenterology and Hepatology, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Rogier Jj', 'Initials': 'RJ', 'LastName': 'de Ridder', 'Affiliation': 'Department of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Hjalmar C', 'Initials': 'HC', 'LastName': 'van Santvoort', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Sperna Weiland', 'Affiliation': 'Department of Research and Development, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Martijn Wj', 'Initials': 'MW', 'LastName': 'Stommel', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hester C', 'Initials': 'HC', 'LastName': 'Timmerhuis', 'Affiliation': 'Department of Research and Development, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Witteman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, The Netherlands.'}, {'ForeName': 'Devica S', 'Initials': 'DS', 'LastName': 'Umans', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Niels G', 'Initials': 'NG', 'LastName': 'Venneman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Vleggaar', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Roy Lj', 'Initials': 'RL', 'LastName': 'van Wanrooij', 'Affiliation': 'Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.'}, {'ForeName': 'Marco J', 'Initials': 'MJ', 'LastName': 'Bruno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fockens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rogier P', 'Initials': 'RP', 'LastName': 'Voermans', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands r.p.voermans@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gut,['10.1136/gutjnl-2021-325632']
1841,35701548,The neurobiological markers of acute alcohol's subjective effects in humans.,"The ingestion of alcohol yields acute biphasic subjective effects: stimulation before sedation. Despite their predictive relevance to the development of alcohol use disorders (AUD), the neurobiological markers accounting for the biphasic effects of alcohol remain poorly understood in humans. Informed by converging lines of evidence, this study tested the hypothesis that alcohol ingestion acutely increases gamma-aminobutyric acid (GABA)-mediated inhibition, which would positively and negatively predict the feeling of stimulation and sedation, respectively. To do so, healthy participants (n = 20) ingested a single dose of 94% ABV alcohol (males: 1.0 ml/kg; females: 0.85 ml/kg) in a randomized placebo-controlled cross-over design. The alcohol's biphasic effects were assessed with the Brief-Biphasic Alcohol Effects Scale, and non-invasive neurobiological markers were measured with transcranial magnetic stimulation, before and every 30 min (up to 120 min) after the complete ingestion of the beverage. Results showed that acute alcohol ingestion selectively increased the duration of the cortical silent period (CSP) as compared to placebo, suggesting that alcohol increases non-specific GABAergic inhibition. Importantly, CSP duration positively and negatively predicted increases in the feeling of stimulation and sedation, respectively, suggesting that stimulation emerges as GABAergic inhibition increases and that sedation emerges as GABAergic inhibition returns to baseline values. Overall, these results suggest that modulations of GABAergic inhibition are central to the acute biphasic subjective effects of alcohol, providing a potential preventive target to curb the progression of at-risk individuals to AUD.",2022,"Results showed that acute alcohol ingestion selectively increased the duration of the cortical silent period (CSP) as compared to placebo, suggesting that alcohol increases non-specific GABAergic inhibition.","['healthy participants (n\u2009=\u200920) ingested a single dose of 94% ABV alcohol (males: 1.0\u2009ml/kg; females: 0.85\u2009ml/kg) in a randomized', 'humans']","['placebo', 'placebo-controlled cross-over design']","['duration of the cortical silent period (CSP', 'feeling of stimulation and sedation', 'gamma-aminobutyric acid (GABA)-mediated inhibition', 'Brief-Biphasic Alcohol Effects Scale, and non-invasive neurobiological markers']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0078137', 'cui_str': 'VBA protocol'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517483', 'cui_str': '0.85'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0374317,"Results showed that acute alcohol ingestion selectively increased the duration of the cortical silent period (CSP) as compared to placebo, suggesting that alcohol increases non-specific GABAergic inhibition.","[{'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Hamel', 'Affiliation': ""Département de kinanthropologie, Faculté des sciences de l'activité physique, Université de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Demers', 'Affiliation': 'Département de pédiatrie, Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Boileau', 'Affiliation': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Marie-Laurence', 'Initials': 'ML', 'LastName': 'Roy', 'Affiliation': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Théoret', 'Affiliation': 'Département de psychologie, Faculté des arts et sciences, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Pierre-Michel', 'Initials': 'PM', 'LastName': 'Bernier', 'Affiliation': ""Département de kinanthropologie, Faculté des sciences de l'activité physique, Université de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Lepage', 'Affiliation': 'Département de pédiatrie, Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, QC, Canada. jean-francois.lepage@usherbrooke.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-022-01354-w']
1842,35701546,ASO Visual Abstract: Rethinking Routine Intensive Care After Cytoreductive Surgery with Heated Intraperitoneal Chemotherapy: The Fiscal Argument.,,2022,,[],['Cytoreductive Surgery with Heated Intraperitoneal Chemotherapy'],[],[],"[{'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.109039,,"[{'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Schwartz', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA. pbschwartz@wisc.edu.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Stahl', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Roberto J', 'Initials': 'RJ', 'LastName': 'Vidri', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Glen E', 'Initials': 'GE', 'LastName': 'Leverson', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Puckett', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Syed N', 'Initials': 'SN', 'LastName': 'Zafar', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Varley', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Ronnekleiv-Kelly', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Al-Niaimi', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Weber', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Abbott', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}]",Annals of surgical oncology,['10.1245/s10434-022-12017-x']
1843,35701451,Effect of a six-week times restricted eating intervention on the body composition in early elderly men with overweight.,"The main aim of the study was to determine the effectiveness of time-restricted eating (TRE) in reducing body fat and lowering body mass index in early elderly men with overweight (65-74 years). An additional goal was to determine the feasibility of applying TRE for extensive use in elderly men. This study included a group of 46 healthy men (EXP = 23 persons, CON = 23 persons). The six-week intervention in the experimental group involved complete abstinence from food intake for 16 h per day, from 08:00 to 12:00 p.m. After the intervention, the body weight decreased in the EXP group (- 1.92 kg) with a 95% CI (1.14-2.70) compared to the CON group. There was also a decrease in the Visceral fat mass (- 0.64 l) with 95% CI (0.46-0.82) and in the waist circumference (- 3.11 cm) with 95% CI (1.89-4.33) in the EXP group compared to the CON group. The skeletal muscle mass did not change significantly. There was no significant change in the control group, either. The application of TRE in early elderly overweight men resulted in positive changes in body composition and visceral fat. All participants succeed in the prescribed diet plan, which shows that TRE is easy to maintain for early elderly overweight men and may become an essential obesity treatment tool in these age groups.",2022,There was also a decrease in the Visceral fat mass (- 0.64 l) with 95% CI (0.46-0.82) and in the waist circumference (- 3.11 cm) with 95% CI (1.89-4.33) in the EXP group compared to the CON group.,"['early elderly overweight men', 'early elderly men with overweight', '46 healthy men (EXP\u2009=\u200923 persons, CON\u2009=\u200923 persons', 'elderly men', 'early elderly men with overweight (65-74\xa0years']","['CON', 'six-week times restricted eating intervention', 'TRE', 'time-restricted eating (TRE']","['Visceral fat mass', 'body composition and visceral fat', 'body weight', 'skeletal muscle mass', 'waist circumference']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",46.0,0.0227408,There was also a decrease in the Visceral fat mass (- 0.64 l) with 95% CI (0.46-0.82) and in the waist circumference (- 3.11 cm) with 95% CI (1.89-4.33) in the EXP group compared to the CON group.,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Domaszewski', 'Affiliation': 'Department of Health Sciences, Institute of Health Sciences, University of Opole, Katowicka 68, 45-060, Opole, Poland. przemyslaw.domaszewski@uni.opole.pl.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Konieczny', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, Prószkowska 76, 45-068, Opole, Poland. m.konieczny@po.edu.pl.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Pakosz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, Prószkowska 76, 45-068, Opole, Poland. p.pakosz@po.edu.pl.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Łukaniszyn-Domaszewska', 'Affiliation': 'Faculty of Economics and Management, Opole University of Technology, Opole, Poland.'}, {'ForeName': 'Wioletta', 'Initials': 'W', 'LastName': 'Mikuláková', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Care, University of Presov, Prešov, Slovak Republic.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, Institute on Aging, University of Florida, Gainesville, USA.'}]",Scientific reports,['10.1038/s41598-022-13904-9']
1844,35701386,"Pericapsular nerve group block for hip fracture is feasible, safe and effective in the emergency department: A prospective observational comparative cohort study.","OBJECTIVES


The pericapsular nerve group (PENG) block was first described for analgesia of hip fracture in 2018. We hypothesised that the PENG block is safe and effective for patients with hip fracture when provided by emergency physicians and trainees in the ED.
METHODS


This was an observational study of routine care. Consecutive patients receiving regional anaesthesia for hip fracture at a single ED were prospectively enrolled. Pain scores were assessed prior to regional anaesthesia then at 15, 30 and 60 min after administration. Maximal reduction in pain scores within 60 min were assessed using the Visual Analogue Scale (at rest and on movement) or the Pain Assessment IN Advanced Dementia tool (at rest). Patients were followed for opioid use for 12 h after regional anaesthesia and adverse events over the duration of admission.
RESULTS


There were 67 eligible patients during the enrolment period, with 52 (78%) prospectively enrolled. Thirty-three received femoral blocks (19 fascia iliaca compartment blocks, 14 femoral nerve blocks) and 19 received a PENG block. Inexperienced providers were able to successfully perform the PENG block. There was no difference in maximum pain score reduction between the groups. There was no difference in adverse effects between groups. Opioid use was similar between the groups. More patients were opioid-free after a PENG block.
CONCLUSIONS


The present study demonstrated that the PENG block can be provided safely and effectively to patients with hip fracture in the ED. On the basis of this pilot study, a larger randomised controlled study should now be designed.",2022,There was no difference in maximum pain score reduction between the groups.,"['emergency department', 'patients with hip fracture in the ED', '67 eligible patients during the enrolment period, with 52 (78%) prospectively enrolled', 'Consecutive patients receiving regional anaesthesia for hip fracture at a single ED were prospectively enrolled', 'patients with hip fracture']","['PENG block', 'femoral blocks (19 fascia iliaca compartment blocks, 14 femoral nerve blocks) and 19 received a PENG block', 'Pericapsular nerve group block for hip fracture']","['Pain scores', 'pain scores', 'Visual Analogue Scale', 'maximum pain score reduction', 'adverse effects']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",67.0,0.0641489,There was no difference in maximum pain score reduction between the groups.,"[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fahey', 'Affiliation': 'Department of Emergency Medicine, Gold Coast University Hospital, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Cripps', 'Affiliation': 'Department of Anaesthesia, Lismore Base Hospital, Lismore, New South Wales, Australia.'}, {'ForeName': 'Aloysius', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Department of Acute Care Medicine, Fiona Stanley Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Sweeny', 'Affiliation': 'Department of Emergency Medicine, Gold Coast University Hospital, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snelling', 'Affiliation': 'Department of Emergency Medicine, Gold Coast University Hospital, Gold Coast, Queensland, Australia.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.14013']
1845,35701830,"NSAIDs in sciatica (NIS): study protocol for an investigator-initiated multicentre, randomized placebo-controlled trial of naproxen in patients with sciatica.","BACKGROUND


Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to treat sciatica, despite insufficient evidence from placebo-controlled trials. NSAIDs may cause serious side effects; hence, there is a strong need to clarify their potential beneficial effects in patients with sciatica.
METHODS


This is a multicentre, randomized, placebo-controlled, parallel-group superiority trial. Participants will be recruited among sciatica patients referred to outpatient clinics at hospitals in Norway who have radiating pain below the knee with a severity score of ≥ 4 on a 0-10 numeric rating scale and clinical signs of nerve root or spinal nerve involvement. The intervention consists of oral naproxen 500 mg or placebo twice daily for 10 days. Participants will report the outcomes and adverse events daily using an electronic case report form. The primary endpoint is change in leg pain intensity from baseline to day 10 based on daily observations. The secondary outcomes are back pain intensity, disability, sciatica symptom severity, rescue medication (paracetamol) consumption, opioid use, ability to work or study, 30% and 50% improvement in leg pain, and global perceived change of sciatica/back problem. The outcomes will be analysed using mixed effects models for repeated measurements. The total duration of follow-up is 12 (± 2) days.
DISCUSSION


This trial aims to evaluate the benefits of naproxen, a non-selective NSAID, in patients with sciatica. No important differences in efficacy have been demonstrated between different NSAIDs in the management of musculoskeletal disorders; hence, the results of this trial will likely be applicable to other NSAIDs.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03347929 . Registered on November 20, 2017.",2022,"No important differences in efficacy have been demonstrated between different NSAIDs in the management of musculoskeletal disorders; hence, the results of this trial will likely be applicable to other NSAIDs.
","['Participants will be recruited among sciatica patients referred to outpatient clinics at hospitals in Norway who have radiating pain below the knee with a severity score of ≥ 4 on a 0-10 numeric rating scale and clinical signs of nerve root or spinal nerve involvement', 'patients with sciatica']","['oral naproxen 500 mg or placebo', 'naproxen', 'placebo']","['back pain intensity, disability, sciatica symptom severity, rescue medication (paracetamol) consumption, opioid use, ability to work or study, 30% and 50% improvement in leg pain, and global perceived change of sciatica/back problem', 'leg pain intensity']","[{'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0234254', 'cui_str': 'Radiating pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0037941', 'cui_str': 'Spinal nerve structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0987999', 'cui_str': 'Naproxen 500 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0579085', 'cui_str': 'Back problem'}]",,0.565473,"No important differences in efficacy have been demonstrated between different NSAIDs in the management of musculoskeletal disorders; hence, the results of this trial will likely be applicable to other NSAIDs.
","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøvle', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, Grålum, Norway. lars.grovle@so-hf.no.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Hasvik', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Holst', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne Julsrud', 'Initials': 'AJ', 'LastName': 'Haugen', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, Grålum, Norway.'}]",Trials,['10.1186/s13063-022-06441-3']
1846,35701800,Antiprogestins reduce epigenetic field cancerization in breast tissue of young healthy women.,"BACKGROUND


Breast cancer is a leading cause of death in premenopausal women. Progesterone drives expansion of luminal progenitor cells, leading to the development of poor-prognostic breast cancers. However, it is not known if antagonising progesterone can prevent breast cancers in humans. We suggest that targeting progesterone signalling could be a means of reducing features which are known to promote breast cancer formation.
METHODS


In healthy premenopausal women with and without a BRCA mutation we studied (i) estrogen and progesterone levels in saliva over an entire menstrual cycle (n = 20); (ii) cancer-free normal breast-tissue from a control population who had no family or personal history of breast cancer and equivalently from BRCA1/2 mutation carriers (n = 28); triple negative breast cancer (TNBC) biopsies and healthy breast tissue taken from sites surrounding the TNBC in the same individuals (n = 14); and biopsies of ER+ve/PR+ve stage T1-T2 cancers and healthy breast tissue taken from sites surrounding the cancer in the same individuals (n = 31); and (iii) DNA methylation and DNA mutations in normal breast tissue (before and after treatment) from clinical trials that assessed the potential preventative effects of vitamins and antiprogestins (mifepristone and ulipristal acetate; n = 44).
RESULTS


Daily levels of progesterone were higher throughout the menstrual cycle of BRCA1/2 mutation carriers, raising the prospect of targeting progesterone signalling as a means of cancer risk reduction in this population. Furthermore, breast field cancerization DNA methylation signatures reflective of (i) the mitotic age of normal breast epithelium and (ii) the proportion of luminal progenitor cells were increased in breast cancers, indicating that luminal progenitor cells with elevated replicative age are more prone to malignant transformation. The progesterone receptor antagonist mifepristone reduced both the mitotic age and the proportion of luminal progenitor cells in normal breast tissue of all control women and in 64% of BRCA1/2 mutation carriers. These findings were validated by an alternate progesterone receptor antagonist, ulipristal acetate, which yielded similar results. Importantly, mifepristone reduced both the TP53 mutation frequency as well as the number of TP53 mutations in mitotic-age-responders.
CONCLUSIONS


These data support the potential usage of antiprogestins for primary prevention of poor-prognostic breast cancers.
TRIAL REGISTRATION


Clinical trial 1 Mifepristone treatment prior to insertion of a levonorgestrel releasing intrauterine system for improved bleeding control - a randomized controlled trial, clinicaltrialsregister.eu, 2009-009014-40 ; registered on 20 July 2009. Clinical trial 2 The effect of a progesterone receptor modulator on breast tissue in women with BRCA1 and 2 mutations, clinicaltrials.gov, NCT01898312 ; registered on 07 May 2013. Clinical trial 3 A pilot prevention study of the effects of the anti- progestin Ulipristal Acetate (UA) on surrogate markers of breast cancer risk, clinicaltrialsregister.eu, 2015-001587-19 ; registered on 15 July 2015.",2022,The progesterone receptor antagonist mifepristone reduced both the mitotic age and the proportion of luminal progenitor cells in normal breast tissue of all control women and in 64% of BRCA1/2 mutation carriers.,"['women with BRCA1 and 2 mutations, clinicaltrials.gov, NCT01898312 ; registered on 07 May 2013', 'premenopausal women', 'clinicaltrialsregister.eu, 2009-009014-40 ; registered on 20 July 2009', 'young healthy women', 'breast cancer risk,\xa0clinicaltrialsregister.eu, 2015-001587-19 ; registered on\xa015 July 2015', 'n =\u200944', 'healthy premenopausal women with and without a BRCA mutation we studied (i) estrogen and progesterone levels in saliva over an entire menstrual cycle (n =\u200920); (ii) cancer-free normal breast-tissue from a control population who had no family or personal history of breast cancer and equivalently from BRCA1/2 mutation carriers (n =\u200928); triple negative breast cancer (TNBC) biopsies and healthy breast tissue taken from sites surrounding the TNBC in the same individuals (n =\u200914); and biopsies of ER+ve/PR+ve stage T1-T2 cancers and healthy breast tissue taken from sites surrounding the cancer in the same individuals (n =\u200931); and (iii) DNA methylation and DNA mutations in normal breast tissue (before and after treatment) from clinical trials']","['levonorgestrel releasing intrauterine system', 'anti- progestin Ulipristal Acetate (UA', 'vitamins and antiprogestins (mifepristone and ulipristal acetate', 'Mifepristone', 'progesterone receptor modulator', 'Progesterone', 'mifepristone']","['TP53 mutation frequency', 'number of TP53 mutations']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0567498', 'cui_str': 'Breast normal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0032662', 'cui_str': 'Population Control'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0557086', 'cui_str': 'No relatives'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0444070', 'cui_str': 'Tissue specimen from breast'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C3653463', 'cui_str': 'Progesterone receptor modulators'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C3178846', 'cui_str': 'Mutation Frequency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.121927,The progesterone receptor antagonist mifepristone reduced both the mitotic age and the proportion of luminal progenitor cells in normal breast tissue of all control women and in 64% of BRCA1/2 mutation carriers.,"[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Bartlett', 'Affiliation': 'Department of Statistical Science, University College London, London, WC1E 7HB, UK.'}, {'ForeName': 'Iona', 'Initials': 'I', 'LastName': 'Evans', 'Affiliation': ""Department of Women's Cancer, UCL EGA Institute for Women's Health, University College London, 74 Huntley Street, London, WC1E 6AU, UK.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': ""Department of Women's Cancer, UCL EGA Institute for Women's Health, University College London, 74 Huntley Street, London, WC1E 6AU, UK.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Barrett', 'Affiliation': ""Department of Women's Cancer, UCL EGA Institute for Women's Health, University College London, 74 Huntley Street, London, WC1E 6AU, UK.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Haran', 'Affiliation': ""Department of Women's Cancer, UCL EGA Institute for Women's Health, University College London, 74 Huntley Street, London, WC1E 6AU, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reisel', 'Affiliation': ""Department of Women's Cancer, UCL EGA Institute for Women's Health, University College London, 74 Huntley Street, London, WC1E 6AU, UK.""}, {'ForeName': 'Kiriaki', 'Initials': 'K', 'LastName': 'Papaikonomou', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Centre for Tumour Biology Department, Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Herzog', 'Affiliation': 'European Translational Oncology Prevention and Screening (EUTOPS) Institute, Universität Innsbruck, 6060, Hall in Tirol, Austria.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Pashayan', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Simões', 'Affiliation': 'Breast Biology Group, Manchester Breast Centre, Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK, England.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Clarke', 'Affiliation': 'Breast Biology Group, Manchester Breast Centre, Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK, England.'}, {'ForeName': 'D Gareth', 'Initials': 'DG', 'LastName': 'Evans', 'Affiliation': ""University of Manchester, St. Mary's Hospital, and University Hospital of South Manchester, Manchester, UK.""}, {'ForeName': 'Talayeh S', 'Initials': 'TS', 'LastName': 'Ghezelayagh', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, 98195, USA.'}, {'ForeName': 'Sakthivignesh', 'Initials': 'S', 'LastName': 'Ponandai-Srinivasan', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Nageswara R', 'Initials': 'NR', 'LastName': 'Boggavarapu', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Parameswaran G', 'Initials': 'PG', 'LastName': 'Lalitkumar', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Sacha J', 'Initials': 'SJ', 'LastName': 'Howell', 'Affiliation': 'Breast Biology Group, Manchester Breast Centre, Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK, England.'}, {'ForeName': 'Rosa Ana', 'Initials': 'RA', 'LastName': 'Risques', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, 98195, USA.'}, {'ForeName': 'Angelique Flöter', 'Initials': 'AF', 'LastName': 'Rådestad', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Dubeau', 'Affiliation': 'Department of Pathology, Keck School of Medicine, USC/Norris Comprehensive Cancer Centre, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Widschwendter', 'Affiliation': ""Department of Women's Cancer, UCL EGA Institute for Women's Health, University College London, 74 Huntley Street, London, WC1E 6AU, UK. martin.widschwendter@uibk.ac.at.""}]",Genome medicine,['10.1186/s13073-022-01063-5']
1847,35701794,The effects of different surgical positions (semi-sitting and lateral position) on the surgical outcomes of large vestibular schwannoma: study protocol for a randomized controlled trial.,"BACKGROUND


There is an ongoing discussion about the advantages and disadvantages of different surgical positions (semi-sitting and lateral position) for vestibular schwannoma surgery. Each position has its advantages, disadvantages, challenges, and risk profiles. The objectives of this study are to compare the effects of different surgical positions (semi-sitting and lateral position) on the outcomes of large vestibular schwannoma, primarily including effectiveness and safety.
METHODS


In this single-centre, open, randomized controlled trial, we will recruit a total of 116 participants according to the inclusion and exclusion criteria who will be randomized to an experimental group or control group. Patients will undergo operations in semi-sitting and lateral positions. The primary endpoint will be the percentage of gross total resection. The secondary endpoints will include the facial nerve function, hearing preservation, surgical position placement time, time of operation (skin-to-skin surgical time), hospital stay, total hospitalization fee, and complications. The follow-up period will be at least 12 months, during which time patients will be evaluated both clinically and radiologically.
DISCUSSION


This issue is still debated after 30 years since the first large comparative study was published in 1989, so the study will be useful. Therefore, more high-quality studies are required to compare clinical outcomes, complications, and other factors associated with these two positions.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900027550 . Registered on 17 November 2019.",2022,"The secondary endpoints will include the facial nerve function, hearing preservation, surgical position placement time, time of operation (skin-to-skin surgical time), hospital stay, total hospitalization fee, and complications.",['116 participants according to the inclusion and exclusion criteria who will be randomized to an experimental group or control group'],['surgical positions (semi-sitting and lateral position'],"['effectiveness and safety', 'facial nerve function, hearing preservation, surgical position placement time, time of operation (skin-to-skin surgical time), hospital stay, total hospitalization fee, and complications', 'percentage of gross total resection']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234290', 'cui_str': 'Seventh cranial nerve function'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}]",116.0,0.0923722,"The secondary endpoints will include the facial nerve function, hearing preservation, surgical position placement time, time of operation (skin-to-skin surgical time), hospital stay, total hospitalization fee, and complications.","[{'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mingchu', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chengbei', 'Initials': 'C', 'LastName': 'Hou', 'Affiliation': 'Centre for Evidence-Based Medicine, Xuanwu Hospital, Beijing, China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongchuan', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xinru', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qingtang', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuhai', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiantao', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China. w15369325269@163.com.'}]",Trials,['10.1186/s13063-022-06437-z']
1848,35701782,Comparison of self versus expert-assisted feedback for cricothyroidotomy training: a randomized trial.,"BACKGROUND


The self-video feedback method may have the potential to provide a low-cost alternative to physician-driven simulation-based training. This study aimed to assess the utility of two video feedback methods by comparing the improvement in performing cricothyroidotomy procedure following self video feedback (trainees review their performance by themselves) and expert-assisted video feedback (trainees review their performance while an emergency physician provides additional feedback).
METHODS


This study was pretest-posttest and two-group designed research performed at a university simulation center with 89 final-year medical students and used a cricothyroidotomy simulation model. After seeing an educational presentation and a best practice video, trainees were randomized into two groups; self video feedback group (SVFG) and expert-assisted video feedback group (EVFG). They performed the cricothyroidotomy before and after the feedback. The procedures were also recorded and scored by two emergency physicians.
RESULTS


There was a statistically significant improvement between pre-feedback and post-feedback assessments in terms of scores received and time needed for the procedures in both SVFG and EVFG groups (p < 0.05). Additionally, the post-feedback assessment scores were higher and time needed for the procedure was lower in the EVFG when compared with SVFG (p < 0.05 for both).
CONCLUSIONS


Results demonstrated significant improvement in cricothyroidotomy performance with both types of video feedback method. Even though the improvement was better in the EVFG compared to the SVFG, the self video feedback may have value especially in situations where expert-assisted feedback is not possible.",2022,There was a statistically significant improvement between pre-feedback and post-feedback assessments in terms of scores received and time needed for the procedures in both SVFG and EVFG groups (p < 0.05).,[],"['self versus expert-assisted feedback for cricothyroidotomy training', 'EVFG', 'cricothyroidotomy simulation model', 'self video feedback group (SVFG) and expert-assisted video feedback group (EVFG']","['time needed for the procedure', 'cricothyroidotomy performance', 'pre-feedback and post-feedback assessments']",[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0131905,There was a statistically significant improvement between pre-feedback and post-feedback assessments in terms of scores received and time needed for the procedures in both SVFG and EVFG groups (p < 0.05).,"[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Aldinc', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey. drhasana@hotmail.com.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Gun', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Yaylaci', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Cigdem Ozkaya', 'Initials': 'CO', 'LastName': 'Senuren', 'Affiliation': 'Department of First and Emergency Aid, Vocational School of Health Services, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Feray', 'Initials': 'F', 'LastName': 'Guven', 'Affiliation': 'Center of Advanced Simulation and Education (CASE), Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Sahiner', 'Affiliation': 'Department of Medical Education, School of Medicine, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Kayayurt', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Suha', 'Initials': 'S', 'LastName': 'Turkmen', 'Affiliation': 'Emergency Department, Hamad Medical Corporation, Doha, Qatar.'}]",BMC medical education,['10.1186/s12909-022-03519-z']
1849,35701778,"Safety and efficacy of Ninjin'yoeito along with iron supplementation therapy for preoperative anemia, fatigue, and anxiety in patients with gynecological disease: an open-label, single-center, randomized phase-II trial.","BACKGROUND


Preoperative anemia affects perioperative outcomes and often causes fatigue and psychological disorders. Therefore, anemia should be treated before a patient undergoes surgery. Ninjin'yoeito (NYT), a Japanese Kampo medicine composed of ginseng and Japanese angelica root with the other 10 herbs, is administered for anemia, fatigue and anxiety; however, there are a few reports that have prospectively examined the effects of NYT before surgery for gynecological diseases. Hence, we tended to investigate its efficacy and safety.
METHODS


In this open-label randomized trial, women with gynecological diseases accompanied by preoperative anemia (defined as < 11.0 g/dL Hemoglobin [Hb]) were randomly assigned (1:1) into the iron supplementation and NYT groups. Patients of the iron supplementation group and the NYT group received 100 mg/day iron supplementation with and without NYT (7.5 g/day) for at least 10 days before surgery. The primary endpoint was improvement in Hb levels before and after treatment, and Cancer Fatigue Scale (CFS) and Visual Analogue Scale for Anxiety (VAS-A) scores between groups. Statistical analyses were performed with Wilcoxon signed rank test, Wilcoxon rank sum test, and Fisher's exact test as appropriate.
RESULTS


Forty patients were enrolled of whom 30 patients were finally analyzed after allocating 15 to each group. There was no difference in the characteristics between both groups. Hb significantly increased in both groups (iron supplementation group, 9.9 ± 0.8 g/dL vs. 11.9 ± 1.6 g/dL; NYT group, 9.8 ± 1.0 g/dL vs. 12.0 ± 1.0 g/dL); the difference in the elevations in Hb between both groups was statistically insignificant (P = 0.72). Contrarily, CFS (17.9 ± 10.2 vs. 8.1 ± 5.2) and VAS-A (56 mm (50-70) vs. 23 mm (6-48)) scores were significantly decreased only in the NYT group and these changes were greater in the NYT group (∆CFS, P = 0.015; ∆VAS-A, P = 0.014). Liver dysfunction occurred in one patient of the NYT group.
CONCLUSIONS


For treating preoperative anemia in women with gynecological conditions, NYT administration along with iron supplementation safely and efficiently improved the preoperative fatigue and anxiety in addition to the recovery from anemia.
TRIAL REGISTRATION


jRCT1051190012 (28/April/2019, retrospectively registered).",2022,"scores were significantly decreased only in the NYT group and these changes were greater in the NYT group (∆CFS, P = 0.015; ∆VAS-A, P = 0.014).","['patients with gynecological disease', 'women with gynecological diseases accompanied by preoperative anemia (defined as\u2009<\u200911.0\xa0g/dL Hemoglobin [Hb', 'women with gynecological conditions', 'Forty patients were enrolled of whom 30 patients were finally analyzed after allocating 15 to each group']","[""Ninjin'yoeito along with iron supplementation therapy"", '100\xa0mg/day iron supplementation with and without NYT']","['scores', 'efficacy and safety', 'preoperative fatigue and anxiety', 'Hb levels before and after treatment, and Cancer Fatigue Scale (CFS) and Visual Analogue Scale for Anxiety (VAS-A) scores', 'Liver dysfunction', 'Safety and efficacy', 'preoperative anemia, fatigue, and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017411', 'cui_str': 'Disorder of female genital organs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C1332836', 'cui_str': 'Cancer fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",40.0,0.0816675,"scores were significantly decreased only in the NYT group and these changes were greater in the NYT group (∆CFS, P = 0.015; ∆VAS-A, P = 0.014).","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Yagi', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Sawada', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan. daasawada@gyne.med.osaka-u.ac.jp.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Kinose', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Takiuchi', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Kodama', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}, {'ForeName': 'Kae', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Mabuchi', 'Affiliation': 'Department of Gynecologic Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Tomimatsu', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Yoshino', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Occupational and Environmental Health, Fukuoka, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamada-oka, Suita-city, Osaka, Japan.'}]",BMC women's health,['10.1186/s12905-022-01824-9']
1850,35701773,"Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND & OBJECTIVE


The use of herbal medicines to treat common oral diseases increases rapidly. Recurrent aphthous stomatitis is one of the most common oral mucosal diseases, which has an unclear etiology and could lead to severe pain and dysfunction. Cinnamaldehyde is a major component of cinnamon bark oil. Biological properties of cinnamaldehyde, such as antioxidant, antitumor, antifungal, cytotoxic, and anti-mutational characteristics, have been identified. Considering the prevalence of recurrent aphthous stomatitis and the importance of using herbal resources for treatment, the present study aimed to evaluate the effect of mucosal adhesive patches containing Cinnamaldehyde on minor recurrent aphthous stomatitis lesions.
MATERIAL & METHODS


In this randomized, double-blind clinical trial, patients were divided into two groups. The intervention group received three daily mucosal adhesive patches to be used in the morning, afternoon, and night. The control group also did the same with a placebo. To evaluate the healing and determine the diameter of the lesions, patients were clinically examined on days zero, 3, 5, and 7. The VAS scale evaluated pain at baseline and after each meal for seven days. The Fisher's exact test, t-test, Shapiro Wilk test, Friedman test, and the Mann-Whitney test were used to analyze the data using the SPSS 20 software.
RESULTS


There was no statistically significant difference in the mean diameter of the inflammatory lesion and pain intensity in the two groups in the baseline (p > 0.05). However, the ulcer size was significantly reduced in the cinnamaldehyde group on the third, fifth, and seventh days of the study. Except for baseline, the mean pain intensity significantly decreased in the cinnamaldehyde group compared to the placebo group (p < 0.05).
CONCLUSION


Cinnamaldehyde mucoadhesive patches effectively reduced and improved aphthous lesions and pain intensity in patients and can be considered a treatment for RAS.
REGISTRATION NUMBER


IRCT20180312039060N2-First registration date: 20/07/2018. The present study was registered as a retrospective study.",2022,"CONCLUSION


Cinnamaldehyde mucoadhesive patches effectively reduced and improved aphthous lesions and pain intensity in patients and can be considered a treatment for RAS.
",['minor recurrent aphthous stomatitis'],"['cinnamaldehyde mucoadhesive patches', 'placebo', 'herbal medicines']","['mean diameter of the inflammatory lesion and pain intensity', 'ulcer size', 'mean pain intensity', 'VAS scale evaluated pain', 'aphthous lesions and pain intensity']","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}]","[{'cui': 'C0055754', 'cui_str': 'cinnamic aldehyde'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.191588,"CONCLUSION


Cinnamaldehyde mucoadhesive patches effectively reduced and improved aphthous lesions and pain intensity in patients and can be considered a treatment for RAS.
","[{'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Molania', 'Affiliation': 'Department of Oral Medicine, Faculty of Dentistry, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Malekzadeh Shafaroudi', 'Affiliation': 'Student Research Committee, Faculty of Dentistry, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Moosazadeh', 'Affiliation': 'Gastroinstitional Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Faeze', 'Initials': 'F', 'LastName': 'Valipour', 'Affiliation': 'Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyyed Sohrab', 'Initials': 'SS', 'LastName': 'Rostamkalaei', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Ayatollah Amoli Branch, Islamic Azad University, Amol, Iran.'}, {'ForeName': 'Negareh', 'Initials': 'N', 'LastName': 'Salehabadi', 'Affiliation': 'Student Research Committee, Faculty of Dentistry, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Maede', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Oral Medicine, Faculty of Dentistry, Mazandaran University of Medical Sciences, Sari, Iran. salehimaede1165@gmail.com.'}]",BMC oral health,['10.1186/s12903-022-02248-5']
1851,35701760,Children's experiences of meals after obesity treatment: a qualitative follow-up four years after a randomized controlled trial.,"BACKGROUND


The practice of eating together, commensality, is rarely explored in the context of childhood obesity treatment. This is noteworthy given long-standing debates about the physical, psychosocial, and societal benefits of meals, especially family meals. Moreover, as children with obesity experience weight bias and stigma both within and outside the home, it is important to examine meals as a locus of social exchange around food and the body. Our study is based on the premises that eating together (i) matters and (ii) occurs in different environments with diverse social organization, where food-related interactions create varying arrangements of individuals, groups, their statuses, and their actions.
METHOD


The study explores children's experiences of meals in different social contexts. Thirty-two children (age 8-10 years) living in Sweden were interviewed, 4 years after they entered an obesity intervention trial. Thematic analysis was applied to the data.
RESULTS


We thematized three meal types, with each meal type having two subthemes: (i) ""The family meal"", with ""Shared routines, rituals, and rules"" and ""Individual solutions and choices""; (ii) ""The school meal"", with ""Rules and norms of the school"" and ""Strategies of the child""; and (iii) ""The friend meal"", with ""Handling food that was disliked"" and ""Enjoyment of food"". These three different meal types carried different experiences of and knowledge about how they were socially organized.
CONCLUSIONS


While the children spoke about the family and school meals as meaningful, the friend meal stood out as particularly positive. Contrary to our expectations, the children did not express experiences of weight bias or obesity stigma around meals, nor did they speak negatively about parental control of their food intake. Our findings, especially regarding the friend meal, have implications for further research into commensality and social influences on eating among children with obesity, from early childhood into adolescence.",2022,"Contrary to our expectations, the children did not express experiences of weight bias or obesity stigma around meals, nor did they speak negatively about parental control of their food intake.","[""Children's experiences of meals after obesity treatment"", 'children with obesity, from early childhood into adolescence', ""children's experiences of meals in different social contexts"", 'Thirty-two children (age 8-10\u2009years) living in Sweden were interviewed, 4 years after they entered an obesity intervention trial']","['meal type having two subthemes: (i) ""The family meal"", with ""Shared routines, rituals, and rules"" and ""Individual solutions and choices""; (ii) ""The school meal"", with ""Rules and norms of the school"" and ""Strategies of the child""; and (iii) ']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0037414', 'cui_str': 'Social context'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0233622', 'cui_str': 'Compulsion expressed as ritual'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],32.0,0.0232032,"Contrary to our expectations, the children did not express experiences of weight bias or obesity stigma around meals, nor did they speak negatively about parental control of their food intake.","[{'ForeName': 'Nicklas', 'Initials': 'N', 'LastName': 'Neuman', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Box 560, Husargatan 3, 751 22, Uppsala, Sweden. nicklas.neuman@ikv.uu.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jörnvi', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Box 560, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Division of Pediatrics, Karolinska Institutet, 141 57, Huddinge, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nordin', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Division of Pediatrics, Karolinska Institutet, 141 57, Huddinge, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Eli', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Box 560, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Nowicka', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Box 560, Husargatan 3, 751 22, Uppsala, Sweden.'}]",BMC pediatrics,['10.1186/s12887-022-03387-y']
1852,35045989,Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.,"BACKGROUND


The role of remdesivir in the treatment of patients in hospital with COVID-19 remains ill defined in a global context. The World Health Organization Solidarity randomized controlled trial (RCT) evaluated remdesivir in patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial. We report on the Canadian findings, with additional demographics, characteristics and clinical outcomes, to explore the potential for differential effects across different health care systems.
METHODS


We performed an open-label, pragmatic RCT in Canadian hospitals, in conjunction with the Solidarity trial. We randomized patients to 10 days of remdesivir (200 mg intravenously [IV] on day 0, followed by 100 mg IV daily), plus standard care, or standard care alone. The primary outcome was in-hospital mortality. Secondary outcomes included changes in clinical severity, oxygen- and ventilator-free days (at 28 d), incidence of new oxygen or mechanical ventilation use, duration of hospital stay, and adverse event rates. We performed a priori subgroup analyses according to duration of symptoms before enrolment, age, sex and severity of symptoms on presentation.
RESULTS


Across 52 Canadian hospitals, we randomized 1282 patients between Aug. 14, 2020, and Apr. 1, 2021, to remdesivir ( n  = 634) or standard of care ( n  = 648). Of these, 15 withdrew consent or were still in hospital, for a total sample of 1267 patients. Among patients assigned to receive remdesivir, in-hospital mortality was 18.7%, compared with 22.6% in the standard-of-care arm (relative risk [RR] 0.83 (95% confidence interval [CI] 0.67 to 1.03), and 60-day mortality was 24.8% and 28.2%, respectively (95% CI 0.72 to 1.07). For patients not mechanically ventilated at baseline, the need for mechanical ventilation was 8.0% in those assigned remdesivir, and 15.0% in those receiving standard of care (RR 0.53, 95% CI 0.38 to 0.75). Mean oxygen-free and ventilator-free days at day 28 were 15.9 (± standard deviation [SD] 10.5) and 21.4 (± SD 11.3) in those receiving remdesivir and 14.2 (± SD 11) and 19.5 (± SD 12.3) in those receiving standard of care ( p  = 0.006 and 0.007, respectively). There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups.
INTERPRETATION


Remdesivir, when compared with standard of care, has a modest but significant effect on outcomes important to patients and health systems, such as the need for mechanical ventilation.  Trial registration : ClinicalTrials.gov, no. NCT04330690.",2022,"There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups.
","['15 withdrew consent or were still in hospital, for a total sample of 1267 patients', 'patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial', 'patients in hospital with COVID-19 remains ill defined in a global context', '52 Canadian hospitals, we randomized 1282 patients between Aug. 14, 2020, and Apr. 1, 2021, to remdesivir ( n  = 634) or standard of care ( n  = 648', 'patients in hospital with COVID-19 in Canada']","['plus standard care, or standard care alone', 'remdesivir']","['hospital mortality', '60-day mortality', 'mechanical ventilation', 'safety events of new dialysis, change in creatinine, or new hepatic dysfunction', 'Mean oxygen-free and ventilator-free days', 'changes in clinical severity, oxygen- and ventilator-free days (at 28 d), incidence of new oxygen or mechanical ventilation use, duration of hospital stay, and adverse event rates']","[{'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1282.0,0.534748,"There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups.
","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Ali', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Tanweer', 'Initials': 'T', 'LastName': 'Azher', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Baqi', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Binnie', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Borgia', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'François M', 'Initials': 'FM', 'LastName': 'Carrier', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Yiorgos Alexandroa', 'Initials': 'YA', 'LastName': 'Cavayas', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Chagnon', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conly', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Costiniuk', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Daley', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Douglas', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Downey', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Duan', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Duceppe', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Durand', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'English', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Farjou', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Evradiki', 'Initials': 'E', 'LastName': 'Fera', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Fontela', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Fowler', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fralick', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Geagea', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Grant', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Luke B', 'Initials': 'LB', 'LastName': 'Harrison', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Havey', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Hoang', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Keynan', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Kosar', 'Initials': 'K', 'LastName': 'Khwaja', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Kolan', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kronfli', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Lau', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fralick', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lostun', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'MacIntyre', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Malhamé', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mangof', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Marlee', 'Initials': 'M', 'LastName': 'McGuinty', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Mergler', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Munan', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Conar', 'Initials': 'C', 'LastName': ""O'Neil"", 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ovakim', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Papenburg', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Parhar', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Seema Nair', 'Initials': 'SN', 'LastName': 'Parvathy', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Patel', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Perez-Patrigeon', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Subitha', 'Initials': 'S', 'LastName': 'Rajakumaran', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Asgar', 'Initials': 'A', 'LastName': 'Rishu', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Malaika', 'Initials': 'M', 'LastName': 'Roba-Oshin', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Rushton', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Salvadori', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Scherr', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Schwartz', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Makeda', 'Initials': 'M', 'LastName': 'Semret', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Ameeta', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Sligl', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Ranjani', 'Initials': 'R', 'LastName': 'Somayaji', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Darrell H S', 'Initials': 'DHS', 'LastName': 'Tan', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Tobin', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Tuong-Vi', 'Initials': 'TV', 'LastName': 'Tran', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tsang', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Turgeon', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vakil', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Weatherald', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Yansouni', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': ""Niagara Health (Ali, Tsang), St. Catharines, Ont.; Biomedical Sciences (Azher), Memorial University of Newfoundland, St. John's, Nfld.; William Osler Health System (Baqi, Binnie, Borgia, Havey), Brampton, Ont.; Hôpital du Sacré-Coeur de Montréal (Cavayas), Montréal, Que.; Emergency Department (Chagnon), Montfort Hospital, Ottawa, Ont.; Departments of Pediatrics (Fontela, Papenburg), Surgery and Critical Care Medicine (Khwaja), McGill University, Montréal, Que.; Divisions of Infectious Diseases (Cheng, Costiniuk, Harrison, M. Klein, Kronfli, T. Lee, Semret, Yansouni), Chronic Viral Illness Service (Costiniuk, M. Klein), Medical Microbiology (Cheng, Yansouni), Internal Medicine (Malhamé, T. Lee), and Infectious Diseases and Immunity in Global Health Program (M. Klein, Kronfli, T. Lee, Papenburg) McGill University Health Centre, Montréal, Que.; Division of Respirology (Lim, Weatherald), Cumming School of Medicine (Conly, Somayaji), and Departments of Critical Care Medicine (Parhar), Repiratory Medicine (Tremblay) and Interventional Pulmonary Medicine (Vakil), University of Calgary, Calgary, Alta.; Health Sciences Centre (Tremblay), University of Calgary, Calgary, Alta.; Discipline of Laboratory Medicine (Daley), Memorial University of Newfoundland, St. John's, Nfld.; Lion's Gate Hospital (Douglas), Vancouver, BC; CCTS at Sunnybrook Research Institute - Centre for Clinical Trial Support (Downey, G. Klein, Lau, Longo, Mangoff, Mergler, Patel, Rajakumaran, Roba-Oshin, Saleem, Tobin, Todd), Toronto, Ont.; Departments of Medicine and Critical Care Medicine (Fowler) and Division of Infectious Diseases (Daneman), Sunnybrook Hospital, Toronto, Ont.; Department of Critical Care Medicine (Pinto, Rishu), Sunnybrook Health Sciences Centre, Toronto, Ont.; Division of Critical Care (Duan), Department of Medicine (Tsang), McMaster University, Hamilton, Ont.; Departments of Anesthesiology (Carrier), Medicine (Duceppe, Kolan), Intensive Care Medicine (Carrier) and Internal Medicine (Duceppe, Kolan) and Internal Medicine Service (Durand), Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Que.; Departments of Medicine (English) and Infectious Diseases (McGuinty), The Ottawa Hospital, Ottawa, Ont.; Department of Medicine (English), Ottawa Hospital Research Institute, Ottawa, Ont.; Niagara Health (Farjou, Tsang), St. Catharines, Ont.; Markham Stouffville Hospital (Fera), Markham, Ont.; Division of General Internal Medicine (Fralick), Department of Medicine, Sinai Health System; Department of Medicine and Critical Care Medicine (Geagea, Lostun), North York General Hospital, Toronto, Ont.; Departments of Pediatrics (Murthy) and Pathology and Laboratory Medicine (Grant), Faculty of Medicine, University of British Columbia, Vancouver, BC; Island Health Authority (Ovakim), University of British Columbia, Vancouver, BC; Division of Infectious Diseases (Hoang), Department of Medicine, Grey Nuns Community Hospital, Edmonton, Alta.; Department of Pharmacology and Therapeutics (Kelly), George and Fay Yee Centre for Healthcare Innovation, University of Manitoba; Departments of Infectious Disease and Medical Microbiology (Keynan) and Internal Medicine (Zarychanski), University of Manitoba, Winnipeg, Man.; Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (Lamontagne), Sherbrooke, Que.; Departments of Critical Care (MacIntyre, Sligl) and Medicine (Singh, Smith), Division of Infectious Diseases (O'Neil), University of Alberta, Edmonton, Alta.; Department of Critical Care Medicine (Munan), Misericordia Community Hospital, Edmonton, Alta.; Misericordia Hospital - Covenant Health (Scherr), Edmonton, Alta.; St. Joseph's Health Care (Parvathy), London, Ont.; Department of Medicine (Perez-Patrigeon), Queen's University, Kingston, Ont.; Queensway Carleton Hospital (Rushton), Nepean, Ont.; Public Health Agency of Canada (Salvadori), Ottawa, Ont.; Unity Health Toronto (Schwartz), Toronto, Ont.; Dalla Lana School of Public Health (N. Lee, Schwartz), University of Toronto, Toronto, Ont.; Department of Medicine (Silverman), Western University, London, Ont.; Division of Infectious Diseases (Tan), St. Michael's Hospital, Toronto, Ont.; Department of Anesthesiology and Critical Care Medicine (Turgeon, Tran), CHU de Québec-Université Laval, Québec, Que.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne,['10.1503/cmaj.211698']
1853,35697942,Treadmill training and physiotherapy similarly improve dual task gait performance: a randomized-controlled trial in Parkinson's disease.,"Motor-cognitive dual tasks are used to investigate the interplay between gait and cognition. Dual task walking in patients with Parkinson's disease (PD) results in decreased gait speed and more importantly in an increased fall risk. There is evidence that physical training may improve gait during dual task challenge. Physiotherapy and treadmill walking are known to improve single task gait. The aim of this study was to investigate the impact of individualized physiotherapy or treadmill training on gait during dual task performance. 105 PD patients were randomly assigned to an intervention group (physiotherapy or treadmill). Both groups received 10 individual interventional sessions of 25 min each and additional group therapy sessions for 14 days. Primary outcome measure was the dual task gait speed. Secondary outcomes were additional gait parameters during dual task walking, UPDRS-III, BBS and walking capacity. All gait parameters were recorded using sensor-based gait analysis. Gait speed improved significantly by 4.2% (treadmill) and 8.3% (physiotherapy). Almost all secondary gait parameters, UPDRS-III, BBS, and walking capacity improved significantly and similarly in both groups. However, interaction effects were not observed. Both interventions significantly improved gait in patients with mild to moderate PD. However, treadmill walking did not show significant benefits compared to individualized physiotherapy. Our data suggest that both interventions improve dual task walking and therefore support safe and independent walking. This result may lead to more tailored therapeutic preferences.",2022,"Almost all secondary gait parameters, UPDRS-III, BBS, and walking capacity improved significantly and similarly in both groups.","['105 PD patients', 'patients with mild to moderate PD', ""Parkinson's disease"", ""patients with Parkinson's disease (PD""]","['Treadmill training and physiotherapy', 'intervention group (physiotherapy or treadmill', 'individualized physiotherapy or treadmill training', 'physical training', 'Dual task walking', 'Physiotherapy and treadmill walking']","['dual task gait speed', 'gait speed', 'dual task walking and therefore support safe and independent walking', 'dual task gait performance', 'additional gait parameters during dual task walking, UPDRS-III, BBS and walking capacity', 'Gait speed', 'secondary gait parameters, UPDRS-III, BBS, and walking capacity', 'fall risk', 'single task gait', 'gait', 'gait during dual task performance']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0429979', 'cui_str': 'Independent walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",105.0,0.030158,"Almost all secondary gait parameters, UPDRS-III, BBS, and walking capacity improved significantly and similarly in both groups.","[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Gaßner', 'Affiliation': 'Department of Molecular Neurology, Universitätsklinikum Erlangen, Molekulare Neurologie, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany. heiko.gassner@uk-erlangen.de.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Trutt', 'Affiliation': 'Parkinson-Klinik Ortenau, Wolfach, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Seifferth', 'Affiliation': 'Department of Molecular Neurology, Universitätsklinikum Erlangen, Molekulare Neurologie, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Friedrich', 'Affiliation': 'Department of Molecular Neurology, Universitätsklinikum Erlangen, Molekulare Neurologie, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Zucker', 'Affiliation': 'Parkinson-Klinik Ortenau, Wolfach, Germany.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Salhani', 'Affiliation': 'Parkinson-Klinik Ortenau, Wolfach, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Adler', 'Affiliation': 'Institut für Medizininformatik, Biometrie und Epidemiologie, FAU Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Winkler', 'Affiliation': 'Department of Molecular Neurology, Universitätsklinikum Erlangen, Molekulare Neurologie, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Jost', 'Affiliation': 'Parkinson-Klinik Ortenau, Wolfach, Germany.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-022-02514-4']
1854,35698282,"Five Versus 10 Pharyngeal Sprays of 10% Lignocaine for Topical Anesthesia During Flexible Bronchoscopy: A Multicenter, Randomized Controlled Trial.","BACKGROUND


Ensuring adequate patient comfort is crucial during bronchoscopy. Although lidocaine spray is recommended for topical pharyngeal anesthesia, the optimum dose of sprays is unclear. We compared 5 versus 10 sprays of 10% lidocaine for topical anesthesia during bronchoscopy.
METHODS


In this investigator-initiated, prospective, multicenter, randomized clinical trial, subjects were randomized to receive 5 (group A) or 10 sprays (group B) of 10% lidocaine. The primary objective was to compare the operator-rated overall procedure satisfaction between the groups.
RESULTS


Two hundred eighty-four subjects were randomized (143 group A and 141 group B). The operator-rated overall procedure satisfaction, VAS [mean (SD)] was similar between the groups [group A, 74.1 (19.9) and group B, 74.3 (18.5), P=0.93]. The VAS scores of patient-rated cough [group A, 32.5 (22.9) and group B, 32.3 (22.2), P=0.93], and operator-rated cough [group A, 29.8 (22.3) and group B, 26.9 (21.5), P=0.26] were also similar. The time to reach vocal cords, overall procedure duration, mean doses of sedatives, the proportion of subjects willing to return for a repeat procedure (if required), and complications were not significantly different. Subjects in group A received significantly less cumulative lidocaine (mg) [group A, 293.9 (11.6) and group B, 343.5 (10.6), P<0.001].
CONCLUSION


During bronchoscopy, topical anesthesia with 5 sprays of 10% lidocaine is preferred as it is associated with a similar operator-rated overall procedure satisfaction at a lower cumulative lidocaine dose compared with 10 sprays.",2022,"The operator-rated overall procedure satisfaction, VAS [mean (SD)] was similar between the groups [group A, 74.1 (19.9) and group B, 74.3 (18.5), P=0.93].",['Two hundred eighty-four subjects'],"['lidocaine', 'Flexible Bronchoscopy', 'lidocaine spray', 'Lignocaine', 'Topical Anesthesia', 'cumulative lidocaine']","['VAS scores of patient-rated cough', 'operator-rated overall procedure satisfaction, VAS [mean (SD', 'operator-rated overall procedure satisfaction', 'time to reach vocal cords, overall procedure duration, mean doses of sedatives, the proportion of subjects willing to return for a repeat procedure (if required), and complications', 'operator-rated cough']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319623', 'cui_str': '84'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",284.0,0.0533991,"The operator-rated overall procedure satisfaction, VAS [mean (SD)] was similar between the groups [group A, 74.1 (19.9) and group B, 74.3 (18.5), P=0.93].","[{'ForeName': 'Hariharan', 'Initials': 'H', 'LastName': 'Iyer', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, Delhi.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Mishra', 'Affiliation': 'Department of Pulmonary Medicine, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Sindhwani', 'Affiliation': 'Department of Pulmonary Medicine, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, Delhi.'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Tiwari', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, Delhi.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Hadda', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, Delhi.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, Delhi.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, Delhi.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Madan', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, Delhi.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000869']
1855,35698234,"Traditional Chinese medicine syndrome differentiation and treatment by stages of Parkinson's disease: study protocol for a multicentre, randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


Parkinson's disease (PD) is a progressive neurodegenerative disease common in aged populations. Classified by Hoehn & Yahr stages, patients are often divided into mild/early stage, moderate/middle stage, and advanced/late stage. With disease progression, PD shows high heterogeneity in each stage. Based on traditional Chinese medicine (TCM) syndrome differentiation theory and our previous works, we found that during the early stage, the main syndrome is Yin deficiency of the liver and kidney; during the moderate stage, the main syndromes are phlegm heat and wind stirring and blood stasis and wind stirring; and during the late stage, the dominant syndromes are deficiency of Yin and Yang and deficiency of Qi and blood. Hence, we proposed a new model of TCM treatment by the stage of PD. Based on Shudi Pingchan formula, an experimental formula of our team, we developed Ziyin Pingchan formula, Jiedu Pingchan formula, and Fuzheng Pingchan formula to treat each stage. This study is designed to evaluate the therapeutic effect of treating Parkinson's disease by stages using traditional Chinese medicine and to provide an evidence base for forming a standardized scheme of diagnosis and treatment.
METHODS


This study is designed as a multicentre, randomized, double-blind, placebo-controlled clinical trial. Patients will be stratified into 3 subgroups according to Hoehn & Yahr stage; 172, 168, and 72 participants will be required to be in the mild PD, moderate PD, and advanced PD subgroups, respectively, and will be randomized into the treatment or control group at a 1:1 ratio. The mild PD subgroup will receive a 48-week intervention, and the other 2 groups will receive a 24-week intervention. All groups will have a follow-up visit 12 weeks after starting the intervention. The intervention group will receive the Ziyin Pingchan formula, Jiedu Pingchan formula, or Fuzheng Pingchan formula, and the control group will receive the corresponding placebo. The primary outcomes will be the first addition of levodopa for the mild PD subgroup, the duration of the ""OFF"" period for the moderate PD subgroup, and the Parkinson's Disease Questionnaire (PDQ-39) for the advanced PD subgroup. The secondary outcomes will also be verified by subgroups, including the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Sleep Scale-2 (PDSS-2), scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT), and the nonmotor symptom scale (NMSS).
EXPECTED OUTCOMES


To our knowledge, this is the first trial to combine TCM syndrome differentiation with PD clinical stages and put it into clinical practice. The results of this trial will provide clinical evidence for the therapeutic effect of TCM formulas on PD patients of all stages and help build a new TCM treatment by stage model of PD.
TRIAL REGISTRATION


This trial is registered at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ).
REGISTRATION NUMBER


ChiCTR2200056373, Date: 2022-02-04, version 1.",2022,"The secondary outcomes will also be verified by subgroups, including the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Sleep Scale-2 (PDSS-2), scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT), and the nonmotor symptom scale (NMSS).
","['Patients will be stratified into 3 subgroups according to Hoehn & Yahr stage; 172, 168, and 72 participants will be required to be in the mild PD, moderate PD, and advanced PD subgroups']","['Ziyin Pingchan formula, Jiedu Pingchan formula, or Fuzheng Pingchan formula, and the control group will receive the corresponding placebo', 'placebo']","['first addition of levodopa for the mild PD subgroup, the duration of the ""OFF"" period for the moderate PD subgroup, and the Parkinson\'s Disease Questionnaire (PDQ-39', ""Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Sleep Scale-2 (PDSS-2), scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT), and the nonmotor symptom scale (NMSS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.520272,"The secondary outcomes will also be verified by subgroups, including the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Sleep Scale-2 (PDSS-2), scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT), and the nonmotor symptom scale (NMSS).
","[{'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Encephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.'}, {'ForeName': 'Sichun', 'Initials': 'S', 'LastName': 'Gu', 'Affiliation': 'Encephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Encephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Encephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.'}, {'ForeName': 'Canxing', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Encephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Encephalopathy Department, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 725, South Wanping Road, Shanghai, China. qingye@shutcm.edu.cn.'}]",Chinese medicine,['10.1186/s13020-022-00625-4']
1856,35698215,Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany: a randomized controlled trial with 5-year follow up.,"BACKGROUND


Integrative medicine is used frequently alongside chemotherapy treatment in pediatric oncology, but little is known about the influence on toxicity. This German, multi-center, open-label, randomized controlled trial assessed the effects of complementary treatments on toxicity related to intensive-phase chemotherapy treatment in children aged 1-18 with the primary outcome of the toxicity sum score. Secondary outcomes were chemotherapy-related toxicity, overall and event-free survival after 5 years in study patients.
METHODS


Intervention and control were given standard chemotherapy according to malignancy & tumor type. The intervention arm was provided with anthroposophic supportive treatment (AST); given as anthroposophic base medication (AMP), as a base medication for all patients and additional on-demand treatment tailored to the intervention malignancy groups. The control was given no AMP. The toxicity sum score (TSS) was assessed using NCI-CTC scales.
RESULTS


Data of 288 patients could be analyzed. Analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints). Furthermore, groups did not differ significantly in the five-year overall and event-free survival follow up.
DISCUSSION


In this trial findings showed that AST was able to be safely administered in a clinical setting, although no beneficial effects of AST between group toxicity scores, overall or event-free survival were shown.",2022,Analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints).,"['children aged 1-18 with the primary outcome of the toxicity sum score', '288 patients could be analyzed', 'pediatric oncology in Germany']","['AST', 'anthroposophic supportive treatment (AST); given as anthroposophic base medication (AMP', 'standard chemotherapy']","['toxicity scores, overall or event-free survival', 'toxicity', 'toxicity measures', 'chemotherapy-related toxicity, overall and event-free survival', 'five-year overall and event-free survival', 'toxicity sum score (TSS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}]",288.0,0.109678,Analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints).,"[{'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': 'Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin, Berlin, Germany. georg.seifert@charite.de.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Blakeslee', 'Affiliation': 'Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Calaminus', 'Affiliation': ""Department of Pediatric Hematology and Oncology, University Children's Hospital, Düsseldorf, Germany.""}, {'ForeName': 'Farid I', 'Initials': 'FI', 'LastName': 'Kandil', 'Affiliation': 'Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Barth', 'Affiliation': 'Institute of Applied Analysis and Numerical Simulation, Research Group for Computational Methods for Uncertainty Quantification, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Toralf', 'Initials': 'T', 'LastName': 'Bernig', 'Affiliation': 'Department of Pediatrics, Martin Luther University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Carl Friedrich', 'Initials': 'CF', 'LastName': 'Classen', 'Affiliation': 'Division of Pediatric Oncology, Hematology and Palliative Medicine Section, Department of Pediatrics and Adolescent Medicine, University Medicine Rostock, Rostock, Germany.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Corbacioglu', 'Affiliation': 'Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Föll', 'Affiliation': 'Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Gottschling', 'Affiliation': 'Center for Palliative Care and Pediatric Pain Medicine, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gruhn', 'Affiliation': 'Department of Pediatrics, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vom Hoff-Heise', 'Affiliation': 'Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Holger N', 'Initials': 'HN', 'LastName': 'Lode', 'Affiliation': 'Department of Pediatric Hematology and Oncology, University Medicine, Greifswald, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': ""Department of Hematology Oncology, University Children's Hospital, Tübingen, Germany.""}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Nathrath', 'Affiliation': 'Pediatric Hematology and Oncology, Klinikum Kassel, Kassel, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Neunhoeffer', 'Affiliation': ""Department of Pediatric Cardiology, Pulmonology and Pediatric Intensive Care Medicine, University Children's Hospital, Tübingen, Germany.""}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Pekrun', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Hospital Bremen-Mitte, Bremen, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Wulff', 'Affiliation': 'Department of Pediatric Hematology-Oncology, Pediatrics III, University Hospital of Essen, Essen, Germany.'}, {'ForeName': 'Tycho', 'Initials': 'T', 'LastName': 'Zuzak', 'Affiliation': 'Department of Pediatric Hematology-Oncology, Pediatrics III, University Hospital of Essen, Essen, Germany.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Henze', 'Affiliation': 'Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Längler', 'Affiliation': 'Department of Integrative Pediatric and Adolescent Medicine, Gemeinschaftskrankenhaus Herdecke, Herdecke, Germany.'}]",BMC cancer,['10.1186/s12885-022-09703-0']
1857,35698553,Evaluation of the tissue thickness of the supraspinatus and biceps long head tendons using ultrasound among elderly patients with unilateral adhesive capsulitis in the freezing phase.,"[Purpose] This study aimed to clarify the changes in the tissue thickness of the abnormal supraspinatus and biceps long-head tendons among elderly patients to select the treatment targets and evaluate the treatment effects in the freezing phase of adhesive capsulitis. [Participants and Methods] Thirty-two elderly patients with unilateral shoulder pain underwent ultrasound of the supraspinatus and biceps long-head tendons, pain evaluation, and orthopedic testing. Both the supraspinatus and biceps long-head tendons were classified as normal, abnormal, and other groups. Participants with negative orthopedic test results were assigned the ""normal group"". Participants with positive orthopedic test results and resting and night pain were assigned the ""abnormal group"". Differences in tissue thickness were calculated from the differences between the symptomatic and non-symptomatic sides. [Results] The thickness of the supraspinatus and biceps long-head tendons was significantly higher in the abnormal than in the normal group. [Conclusion] This study clarified the changes in tissue thickness of the abnormal supraspinatus and biceps long-head tendons among elderly patients to select the treatment targets and assess the treatment effects in the freezing phase of adhesive capsulitis. The study results suggest the usefulness of ultrasound for selecting the treatment targets for analgesia and assessing the treatment efficacy in cases of adhesive-capsulitis freezing phase.",2022,The thickness of the supraspinatus and biceps long-head tendons was significantly higher in the abnormal than in the normal group.,"['Participants with positive orthopedic test results and resting and night pain', 'Thirty-two elderly patients with unilateral shoulder pain underwent ultrasound of the supraspinatus and biceps long-head tendons, pain evaluation, and orthopedic testing', 'elderly patients', 'Participants and Methods', 'elderly patients with unilateral adhesive capsulitis in the freezing phase', 'Participants with negative orthopedic test']",[],"['thickness of the supraspinatus and biceps long-head tendons', 'tissue thickness']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0234255', 'cui_str': 'Night pain'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",[],"[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",32.0,0.0420654,The thickness of the supraspinatus and biceps long-head tendons was significantly higher in the abnormal than in the normal group.,"[{'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Ohya', 'Affiliation': 'Department of Physical Therapy, Faculty of Rehabilitation, Tokyo Professional University of Health Science: 2-22-10 Shiohama, Koto-ku, Tokyo 135-0043, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Physical Therapy, Graduate School of Human Health Sciences, Tokyo Metropolitan University, Japan.'}]",Journal of physical therapy science,['10.1589/jpts.34.426']
1858,35698552,The effect of median nerve mobilization on two point discrimination.,"[Purpose] Two-point discrimination (TPD) is expressed as the minimum distance at which two mechanical stimuli applied simultaneously to the skin can be perceived as two separate points. The aim of this study was to investigate the effect of median nerve mobilization on TPD in healthy adults. [Participants and Methods] This study included 120 healthy adults. Participants were randomized according to their gender into the Neural Mobilization Group (NMG) and Control Group (CG). Demographic data of the participants (gender, age, height, weight, BMI, smoking) were recorded and TPD measurement was performed with baseline aesthesiometer on the palm with distal phalanges of the thumb, index and middle finger on the right-left hand. After the baseline TPD test, participants in the NMG performed Median Nerve Mobilization for 14 days. Measurements were taken before and after training. [Results] A statistically significant difference was found in all other measurements in both groups, except for the right and left palm TPD measurements in the control group. [Conclusion] It is thought that it would be beneficial to investigate the healing effects of the neural mobilization applications, which include all parts of the nerve line in disease conditions.",2022,"A statistically significant difference was found in all other measurements in both groups, except for the right and left palm TPD measurements in the control group.","['Participants and Methods', 'healthy adults', '120 healthy adults']","['median nerve mobilization', 'Neural Mobilization Group (NMG) and Control Group (CG']","['Median Nerve Mobilization', 'right and left palm TPD measurements']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",120.0,0.0752413,"A statistically significant difference was found in all other measurements in both groups, except for the right and left palm TPD measurements in the control group.","[{'ForeName': 'Gulay Aras', 'Initials': 'GA', 'LastName': 'Bayram', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Science, Istanbul Medipol University: Istanbul 34810, Turkey.'}, {'ForeName': 'Pinar Kaya', 'Initials': 'PK', 'LastName': 'Ciddi', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Science, Istanbul Medipol University: Istanbul 34810, Turkey.'}, {'ForeName': 'Cafer', 'Initials': 'C', 'LastName': 'Marangoz', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Istanbul Medipol University, Turkey.'}]",Journal of physical therapy science,['10.1589/jpts.34.422']
1859,35698541,Comparison of the Modified Lumbar Pelvic Belt with the Current Belt on Low Back and Pelvic Pain in Pregnant Women.,"Background


Low back pain is one of the most common problems for pregnant women during pregnancy. Most belts are designed for supporting the surface of the symphysis pubis or upper anterior iliac spine without any support in the lumbar region.
Objective


This study aimed to compare the related effects between the new design and the current belt on the pain and function of pregnant women.
Material and Methods


In this randomized control trial study, 48 pregnant women with pelvic and lumbar pain participated. The participants were randomly divided into three groups: current belt, modified belt, and control. Pain intensity assessment, pelvic girdle (PG), and Oswestry disability index (ODI) questionnaires were utilized at the beginning of the study and three weeks later.
Results


The pain intensity decreased more in the modified belt group than in the current belt group. ODI and PG scores decreased in two belt groups after three weeks of follow-up. However, this decrease was greater in the modified belt group, there was no statistically significant difference.
Conclusion


The disability decreased in both groups using the belts, and their function was improved. Accordingly, the use of a modified belt with lumbar and PG support can significantly reduce back and pelvic pain in pregnant women compared to the current pelvic belt.",2022,"Accordingly, the use of a modified belt with lumbar and PG support can significantly reduce back and pelvic pain in pregnant women compared to the current pelvic belt.","['48 pregnant women with pelvic and lumbar pain participated', 'pregnant women during pregnancy', 'Pregnant Women', 'pregnant women']",['Modified Lumbar Pelvic Belt with the Current Belt'],"['pain intensity', 'Low Back and Pelvic Pain', 'back and pelvic pain', 'ODI and PG scores', 'disability', 'Pain intensity assessment, pelvic girdle (PG), and Oswestry disability index (ODI) questionnaires']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0684083', 'cui_str': 'Structure of pelvic girdle'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",48.0,0.0166722,"Accordingly, the use of a modified belt with lumbar and PG support can significantly reduce back and pelvic pain in pregnant women compared to the current pelvic belt.","[{'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Heydari', 'Affiliation': 'PhD Candidate, Department of Orthotics and Prosthetics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Aminian', 'Affiliation': 'PhD, Department of Orthotics and Prosthetics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Biglarian', 'Affiliation': 'PhD, Department of Biostatistics and Epidemiology, Social Determinants of Health Research center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shokrpour', 'Affiliation': 'MD, Department of Gynecology and Obstetrics, School of Medicine, Endocrinology and Metabolism Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mardani', 'Affiliation': 'PhD, Department of Orthotics and Prosthetics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Journal of biomedical physics & engineering,['10.31661/jbpe.v0i0.2111-1427']
1860,35698483,Childhood maltreatment class and sexually violent behavior among university men in Vietnam.,"Background


Sexual violence against women remains a global public health problem, with Southeast Asia having among the highest rates of violence victimization globally. Exposure to violence in adolescence--a highly prevalent experience in Vietnam--is associated with later perpetration of violence against others. However, childhood maltreatment as a latent construct is understudied, with most analyses focusing on theoretical categories, potentially missing key patterns of victimization, particularly poly-victimization. Poor understanding of these experience limits researchers' ability to predict and intervene upon cyclical perpetration of violence. This study aims to identify latent classes of childhood maltreatment, and to test associations between class membership and sexually violent behavior during the first 12 months of university in a sample of Vietnamese men.
Methods and findings


Heterosexual and bisexual men aged 18-24 matriculating into two universities in Hanoi were recruited for the randomized controlled trial of GlobalConsent, a six-module online sexual-violence prevention program. Participants (N = 793) completed a baseline survey, were randomized 1:1 to GlobalConsent or attention control, and were invited to complete post-test surveys at six-months post-baseline and 12-months post-baseline. Validated scales were employed to assess childhood maltreatment and past-six-month sexually violent behavior at each post-test. Latent class analysis identified four classes of childhood maltreatment: Limited-to-no, physical, physical and emotional, and poly-victimization. Associations between childhood maltreatment class and sexually violent behavior demonstrate a threshold effect, wherein poly-victimized men were significantly more likely than men in other classes to have engaged in sexually violent behavior during the 12-month follow-up period.
Conclusions


There is a vital need for screening and intervention with men who have experienced childhood maltreatment in Vietnam to prevent future violence perpetration. Education is needed to break the cycle of violence intergenerationally and in romantic relationships by changing harmful norms around men's sexual privilege and the normalization of childhood maltreatment.",2022,Exposure to violence in adolescence--a highly prevalent experience in Vietnam--is associated with later perpetration of violence against others.,"['class membership and sexually violent behavior during the first 12 months of university in a sample of Vietnamese men', 'university men in Vietnam', 'Heterosexual and bisexual men aged 18-24 matriculating into two universities in Hanoi', 'Participants (N\xa0=\xa0793) completed a baseline survey']","['GlobalConsent, a six-module online sexual-violence prevention program', 'GlobalConsent or attention control']",[],"[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],793.0,0.0962347,Exposure to violence in adolescence--a highly prevalent experience in Vietnam--is associated with later perpetration of violence against others.,"[{'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Anderson', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University, 1518 Clifton Rd, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Bergenfeld', 'Affiliation': 'Hubert Department of Global Health and Department of Sociology, Emory University, 1518 Clifton Rd, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Yuk Fai', 'Initials': 'YF', 'LastName': 'Cheong', 'Affiliation': 'Department of Psychology, Emory University, 36 Eagle Row, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Tran Hung', 'Initials': 'TH', 'LastName': 'Minh', 'Affiliation': 'Center for Creative Initiatives in Health and Population, 48, 251/8 Nguyen Khang str, Cau Giay, Hanoi, 100000, Viet Nam.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Yount', 'Affiliation': 'Hubert Department of Global Health and Department of Sociology, Emory University, 1518 Clifton Rd, Atlanta, GA, 30322, USA.'}]",SSM - population health,['10.1016/j.ssmph.2022.101103']
1861,35698469,Comparative Evaluation of Two Different Types of Abutments in Relation to Post-prosthetic Bone Resorption and Periodontal Pocket Depth: A Randomized Controlled Clinical Trial With a One-Year Follow-Up.,"BACKGROUND AND AIM


In the past few years, the number of studies conducted on the designs of abutments and related materials has increased. The restoration is performed over the implant using prefabricated standard abutments. Due to the problems encountered in relation to bone resorption following restoration, other types of abutment designs have been introduced in the dental field such as molded abutments usually fabricated by the lost-wax technique and computer-designed abutments produced by three-dimensional (3D) printing technology. The aim of this study was to compare the clinical performance of molded abutments and computer-designed 3D printed abutments in terms of the bone loss around the implant and the depth of periodontal pockets in a one-year observation period.
METHODS


The research sample consisted of 32 dental implants for patients who required two adjacent implants. Patients were randomly allocated into two groups: in the first group, the patients received molded abutments, whereas, in the second group, the patients received 3D printed abutments with an allocation ratio of 1:1. In the molded abutment group, the plastic abutments were waxed and poured using the Ni-Cr mixture in the lost-wax technique, while in the printed abutment group, the abutments were designed by a computer program and printed using the Cr-Co mixture employing a 3D laser printer. The bone level and pocket depth around the implant were evaluated at 3, 6, and 12 months following cementation.
RESULTS


After one year, there were significant differences in the bone resorption mean values between the 3D laser-printed abutment group (0.43±0.11) and molded abutment group (0.54±0.11). In addition, there were significant differences in the mean values of probing depth between the 3D laser-printed abutment group (3.39±0.12) and molded abutment group (3.53±0.08). Therefore, the 3D laser-printed abutment was slightly better and had a lower bone loss degree than the molded abutment.
CONCLUSION


Within the limitations of the current work, the mean bone resorption for both types of abutments was within the normal limits. However, the implants that were restored using the printed abutments had less bone resorption than those restored using the molded abutments.",2022,"After one year, there were significant differences in the bone resorption mean values between the 3D laser-printed abutment group (0.43±0.11) and molded abutment group (0.54±0.11).","['32 dental implants for patients who required two adjacent implants', 'Two Different Types of Abutments in Relation to Post-prosthetic Bone Resorption and Periodontal Pocket Depth']",['molded abutments and computer-designed 3D printed abutments'],"['bone level and pocket depth', 'bone resorption mean values', 'mean values of probing depth', 'bone resorption', 'mean bone resorption']","[{'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0369241', 'cui_str': 'Filamentous fungus'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]",32.0,0.0304959,"After one year, there were significant differences in the bone resorption mean values between the 3D laser-printed abutment group (0.43±0.11) and molded abutment group (0.54±0.11).","[{'ForeName': 'Mohammad Anas', 'Initials': 'MA', 'LastName': 'Almodalal', 'Affiliation': 'Department of Fixed Prosthodontics, University of Damascus Faculty of Dentistry, Damascus, SYR.'}, {'ForeName': 'Mhd Luai', 'Initials': 'ML', 'LastName': 'Morad', 'Affiliation': 'Department of Fixed Prosthodontics, University of Damascus Faculty of Dentistry, Damascus, SYR.'}, {'ForeName': 'Mohammad Y', 'Initials': 'MY', 'LastName': 'Hajeer', 'Affiliation': 'Department of Orthodontics, University of Damascus Faculty of Dentistry, Damascus, SYR.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Harfouche', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry, Damascus, SYR.'}]",Cureus,['10.7759/cureus.25807']
1862,35698460,Exploring the applicability of virtual reality- enhanced education on extrovert and introvert EFL learners' paragraph writing.,"During the past decade, Virtual reality (VR)-enhanced education has been adopted as a pedagogically new learning approach to smooth the learning progress. With the rise of VR-enhanced activities, investigating the effect of personality types of EFL learners on their writing performance to use VR-based instruction for learning may be a crucial factor influencing their achievement. This study was an attempt to research the impact of VR- enhanced classes on paragraph writing of extrovert and introvert English foreign language (EFL) Learners. To achieve the purpose of the study, first, the Preliminary English Test (PET) was administered for ensuring the homogeneity of the sample. Once the homogeneity was established, a total of 52 EFL intermediate students were selected and placed into two comparative and two control groups, with 13 participants in each group. Four groups took part in the study, with two groups undergoing treatment with the non-VR teaching approach of paragraph writing and two groups undergoing treatment of VR-enhanced education. Among these four groups, two consisted of introverts and two extroverts that were identified through Eysenck Personality Inventory. The two comparative groups received 12 sessions of VR-enhanced education in online classes (instead of drawing pictures and sharing them within their group, they watched the process activities in the VR environment.), but the control group received learning writing paragraphs through using instructor's instructional materials. After 6-weeks of treatment sessions, all participants of the study took the post-test. According to the results, the VR-enhanced education was more effective than the non-VR teaching approach in developing paragraph writing of both introverts and extroverts. Moreover, the results of the research showed no significant differences between the performance of the introverts and extroverts, meaning that both had the same performance. The results of this study may pave the way for teachers to use VR-based technology in online and traditional classes without worrying about how learners with different personality traits respond.",2022,"According to the results, the VR-enhanced education was more effective than the non-VR teaching approach in developing paragraph writing of both introverts and extroverts.",['52 EFL intermediate students'],"[""12 sessions of VR-enhanced education in online classes (instead of drawing pictures and sharing them within their group, they watched the process activities in the VR environment.), but the control group received learning writing paragraphs through using instructor's instructional materials"", 'VR-enhanced education']",['Eysenck Personality Inventory'],"[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0451152', 'cui_str': 'Eysenck personality inventory'}]",52.0,0.034353,"According to the results, the VR-enhanced education was more effective than the non-VR teaching approach in developing paragraph writing of both introverts and extroverts.","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Khodabandeh', 'Affiliation': 'Department of Linguistics and Foreign Languages, Faculty of Humanities, Payame Noor University, Tehran, Iran.'}]",International journal of educational technology in higher education,['10.1186/s41239-022-00334-w']
1863,35698432,Use of recognition of laterality through implicit motor imagery for the improvement of postural control and balance in subacute stroke patients: a randomized controlled study.,"INTRODUCTION


Motor Imagery techniques may be used as a complement to the recovery of motor sequelae after a stroke, as during the evocation of a movement the activation of neuronal circuits involved in the actual execution of the movement occurs.
PATIENTS AND METHODS


A simple-blind randomized controlled trial was conducted. A total of 38 patients were randomly assigned to a study group. Both groups performed, for four weeks, five weekly sessions of neurorehabilitation and three weekly sessions of experimental or control intervention, respectively.The experimental group training the recognition of laterality, while the control group the recognition of body parts. Participants were evaluated pre and post intervention with posturography parameters -Sway area (AREA), Sway path length (LONG), difference in weigthload between lower limbs (DIFLOAD)-, the Berg Balance scale (BBS), the Barthel Index (BI), the Time Up and Go Test (TUG), the Functional Ambulation Categories (FAC), and the quality-of-life scale for stroke (ECVI-38).
RESULTS


After performing the intragroup analysis, statistical significance was obtained for AREA (p < 0.001), LONG (p = 0.04), DIFLOAD (p = 0.02), BBS (p < 0.001), BI (p < 0.001), FAC (p < 0.001), and ECVI-38 (p < 0.001) in the experimental group; and for DIFLOAD (p = 0.01), BBS (p = 0.001), BI (p = 0.001), TUG (p = 0.04), FAC (p = 0.03), and ECVI-38 (p = 0.003) in the control group. In the intergroup analysis, statistical significance was obtained for AREA (p = 0.03), BBS (p = 0.03), FAC (p = 0.02) and ECVI-38 (p = 0.002) at postintervention time.
CONCLUSIONS


Combined use of physical rehabilitation and recognition of laterality through implicit motor imagery tasks, improves balance and functions related to postural control in subacute stroke patients.",2022,"In the intergroup analysis, statistical significance was obtained for AREA (p = 0.03), BBS (p = 0.03), FAC (p = 0.02) and ECVI-38 (p = 0.002) at postintervention time.
","['38 patients', 'subacute stroke patients']",['implicit motor imagery'],"['ECVI-38', 'FAC', 'BBS', 'posturography parameters -Sway area (AREA), Sway path length (LONG), difference in weigthload between lower limbs (DIFLOAD)-, the Berg Balance scale (BBS), the Barthel Index (BI), the Time Up and Go Test (TUG), the Functional Ambulation Categories (FAC), and the quality-of-life scale for stroke (ECVI-38']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",38.0,0.0380804,"In the intergroup analysis, statistical significance was obtained for AREA (p = 0.03), BBS (p = 0.03), FAC (p = 0.02) and ECVI-38 (p = 0.002) at postintervention time.
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Díaz-López', 'Affiliation': 'Hospital Universitario de Móstoles, 28935 Móstoles, España.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Monge-Pereira', 'Affiliation': 'Universidad de Vigo, Pontevedra, España.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jodra-Centeno', 'Affiliation': 'Hospital Universitario de Móstoles, 28935 Móstoles, España.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Molina-Rueda', 'Affiliation': 'Universidad Rey Juan Carlos, Madrid, España.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Miangolarra-Page', 'Affiliation': 'Universidad Rey Juan Carlos, 28922 Alcorcón, España.'}]",Revista de neurologia,['10.33588/rn.7412.2022039']
1864,35698927,"A double-blind, randomized, placebo-controlled phase 2 trial evaluating the selective dihydroorotate dehydrogenase inhibitor vidofludimus calcium in relapsing-remitting multiple sclerosis.","OBJECTIVE


Inhibition of dihydroorotate dehydrogenase suppresses magnetic resonance imaging brain lesions and disease activity in multiple sclerosis but has limiting tolerability. We assessed the safety and efficacy of vidofludimus calcium, a novel, selective dihydroorotate dehydrogenase inhibitor, in patients with relapsing-remitting multiple sclerosis.
METHODS


This double-blind, 24 weeks, placebo-controlled, phase 2 trial (EMPhASIS) enrolled patients 18-55 years with relapsing-remitting multiple sclerosis. Eligible patients were randomly assigned (1:1:1) to once-daily vidofludimus calcium (30 mg or 45 mg) or placebo. The primary endpoint was the cumulative number of combined unique active lesions to week 24 between vidofludimus calcium 45 mg and placebo (clinicalTrials.gov number NCT03846219; EudraCT 2018-001896-19).
RESULTS


After 24 weeks, the mean cumulative number of combined unique active lesions was 6.4 (95% CI: 2.8-13.9) with placebo compared to 2.4 (95% CI: 1.1-4.9) with vidofludimus calcium 45 mg (rate ratio 0.38, 95% CI: 0.22-0.64; p = 0.0002); the rate ratio between vidofludimus calcium 30 mg and placebo was 0.30 (95% CI: 0.17-0.53; p < 0.0001). Treatment-emergent adverse events occurred in 30 (44%) of patients assigned placebo and 60 (43%) of patients assigned vidofludimus calcium. Serious adverse events occurred in one (1%) assigned placebo and two (1%) assigned vidofludimus calcium. No increased incidence of infectious, hepatic, or renal treatment-emergent adverse events or serious adverse events was observed.
INTERPRETATION


Treatment with vidofludimus calcium led to a reduction in new magnetic resonance imaging lesions in patients with relapsing-remitting multiple sclerosis and was well tolerated with a favorable safety profile. Assessment in longer, larger trials is justified.",2022,Serious adverse events occurred in one (1%) assigned placebo and two (1%) assigned vidofludimus calcium.,"['relapsing-remitting multiple sclerosis', 'patients 18-55\u2009years with relapsing-remitting multiple sclerosis', 'patients with relapsing-remitting multiple sclerosis', 'Eligible patients']","['dihydroorotate dehydrogenase', 'selective dihydroorotate dehydrogenase inhibitor vidofludimus calcium', 'vidofludimus calcium', 'vidofludimus calcium, a novel, selective dihydroorotate dehydrogenase inhibitor', 'placebo', 'vidofludimus calcium (30\u2009mg or 45\u2009mg) or placebo']","['adverse events', 'rate ratio', 'mean cumulative number of combined unique active lesions', 'Serious adverse events', 'incidence of infectious, hepatic, or renal treatment-emergent adverse events or serious adverse events', 'cumulative number of combined unique active lesions']","[{'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0058099', 'cui_str': 'Dihydroorotate dehydrogenase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2974101', 'cui_str': 'vidofludimus'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.58565,Serious adverse events occurred in one (1%) assigned placebo and two (1%) assigned vidofludimus calcium.,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wolf', 'Affiliation': 'Lycalis sprl, Brussels, Belgium.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'De Stefano', 'Affiliation': 'Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Sellner', 'Affiliation': 'Department of Neurology, Landesklinikum Mistelbach-Gänserndorf, 2130, Mistelbach, Austria.'}, {'ForeName': 'Viktoriia', 'Initials': 'V', 'LastName': 'Gryb', 'Affiliation': 'Regional Clinical Hospital Department of Vascular Neurology, Ivano-Frankivsk, Ukraine.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Rejdak', 'Affiliation': 'Medical University of Lublin, Department of Neurology, Jaczewskiego 8, 20-954, Lublin, Poland.'}, {'ForeName': 'Plamen Stoyanov', 'Initials': 'PS', 'LastName': 'Bozhinov', 'Affiliation': 'Medical University of Pleven, 1 Saint Kliment Ohridski Street, 5800, Pleven, Bulgaria.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Tomakh', 'Affiliation': 'LLC ""INET-09"" 32, Zhabotinskogo Leonida Street, Zaporozhye, Ukraine.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Skrypchenko', 'Affiliation': 'Kharkiv Regional Clinical Hospital Department of Neurology, Kharkiv, Ukraine.'}, {'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Muehler', 'Affiliation': 'Immunic AG, Lochhamer Schlage 21, 82166, Gräfelfing, Germany.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51574']
1865,35699377,Impact of lurasidone on health-related quality of life in adults with bipolar depression: a post-hoc analysis.,"OBJECTIVE


The objective of this post-hoc analysis was to assess the impact of lurasidone monotherapy on health-related quality of life (HRQoL) in adults with bipolar depression.
METHODS


Data were analyzed from a 6-week randomized, double-blind (DB), placebo-controlled trial of lurasidone monotherapy (NCT00868699) and a 6-month open label extension (OLE; NCT00868959). Patients who received lurasidone monotherapy or placebo during the DB trial were eligible to continue or switch to lurasidone monotherapy during the OLE. The 16-item Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) was collected at DB baseline, DB week 6/OLE baseline, OLE month 3, and OLE month 6. Effect size (ES) and mean changes from baseline were reported for Q-LES-Q-SF total and item scores during the DB trial and OLE, respectively.
RESULTS


Of 485 patients in the DB trial (lurasidone monotherapy:  n  = 323; placebo:  n  = 162), 316 patients continued or switched to lurasidone monotherapy during the OLE. Significant improvements in Q-LES-Q-SF scores in lurasidone vs. placebo were reported for 13 of 16 items (all  p  < .05) at DB week 6. The greatest improvements were overall life satisfaction (ES = 0.57), social relationships (0.55), medication satisfaction (0.48), family relationships (0.46), and ability to function in daily life (0.45, all  p  < .001). Improvements in Q-LES-Q-SF total and item scores were sustained at OLE month 6.
CONCLUSIONS


Treatment with lurasidone provided a significant improvement across HRQoL items including overall life satisfaction, social and family relationships, medication satisfaction, and ability to function in daily life. Improvements were sustained during the 6-month OLE.",2022,"CONCLUSIONS


Treatment with lurasidone provided a significant improvement across HRQoL items including overall life satisfaction, social and family relationships, medication satisfaction, and ability to function in daily life.","['n \u2009=\u2009323', 'adults with bipolar depression', '485 patients in the DB trial', 'n \u2009=\u2009162), 316 patients continued or switched to lurasidone monotherapy during the OLE']","['lurasidone', 'lurasidone monotherapy or placebo', 'lurasidone monotherapy', 'placebo']","['overall life satisfaction', 'health-related quality of life', 'health-related quality of life (HRQoL', 'ability to function in daily life', 'overall life satisfaction, social and family relationships, medication satisfaction, and ability to function in daily life', 'Q-LES-Q-SF scores', 'social relationships (0.55), medication satisfaction', 'Q-LES-Q-SF total and item scores', '16-item Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517462', 'cui_str': '0.55'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0559741', 'cui_str': 'Item score'}]",316.0,0.479213,"CONCLUSIONS


Treatment with lurasidone provided a significant improvement across HRQoL items including overall life satisfaction, social and family relationships, medication satisfaction, and ability to function in daily life.","[{'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Dembek', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}, {'ForeName': 'Yongcai', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}, {'ForeName': 'Vamshi Ruthwik', 'Initials': 'VR', 'LastName': 'Anupindi', 'Affiliation': 'IQVIA, Falls Church, VA, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Laubmeier', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2022.2083400']
1866,35699263,Effectiveness of the Therapy Program for Management of Chronic Cough: Preliminary Data From a Randomized Clinical Trial.,"PURPOSE


The purpose of this study is to analyze the effectiveness of the Therapy Program for Management of Chronic Cough (TMCC) in laryngeal sensations and symptoms related to the cough in individuals with chronic refractory cough (CRC).
METHOD


This research is a randomized double-blind clinical trial (Register Number: RBR-4m6x29). Eleven participants were allocated to two groups by parallel randomization: The Experimental Group-consisting of six individuals who underwent the TMCC; and the Control Group-consisting of five individuals who underwent the Comprehensive Vocal Rehabilitation Program (CVRP). Two primary outcomes were analyzed: self-perception of laryngeal sensations (Newcastle Laryngeal Hypersensitivity Questionnaire [LHQ-Br]) and self-perception of symptoms of upper airway-related cough (Cough Severity Index [CSI-Br]). The two-way repeated-measures analysis of variance was used to compare the evaluation moments and intervention groups. For multiple comparisons, the Tukey test with Bonferroni correction was used. To evaluate the effect size, eta partial square was used.
RESULTS


There was no difference between groups for any outcomes analyzed. There was a statistically significant difference with a large effect size for the moment factor in all outcomes. A statistically significant difference was observed with a large effect size for the interaction effect between group and moment for LHQ-Br total and CSI-Br psychological and functional.
CONCLUSIONS


The TMCC and CVRP were effective for the rehabilitation of CRC, considering the viewpoint of the subject. The TMCC improved laryngeal sensations and psychological and functional symptoms, while CVRP was relevant to improve psychological and functional symptoms in individuals with CRC.",2022,There was no difference between groups for any outcomes analyzed.,"['Eleven participants', 'individuals with CRC', 'individuals with chronic refractory cough (CRC', 'Chronic Cough']","['TMCC', 'Therapy Program', 'Control Group-consisting of five individuals who underwent the Comprehensive Vocal Rehabilitation Program (CVRP']","['psychological and functional symptoms', 'LHQ-Br total and CSI-Br psychological and functional', 'self-perception of laryngeal sensations (Newcastle Laryngeal Hypersensitivity Questionnaire [LHQ-Br]) and self-perception of symptoms of upper airway-related cough (Cough Severity Index [CSI-Br', 'laryngeal sensations and psychological and functional symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3494227', 'cui_str': 'Spinocranial Irradiation'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0027983', 'cui_str': 'Newcastle disease'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",11.0,0.0371845,There was no difference between groups for any outcomes analyzed.,"[{'ForeName': 'Vanessa Veis', 'Initials': 'VV', 'LastName': 'Ribeiro', 'Affiliation': 'Speech-Language Pathology Department, Universidade Federal de São Paulo - UNIFESP, Brazil.'}, {'ForeName': 'Leonardo Wanderley', 'Initials': 'LW', 'LastName': 'Lopes', 'Affiliation': 'Speech-Language Pathology Department, Universidade Federal da Paraíba - UFPB, Cidade Universitária, Conjunto Presidente Castelo Branco III, Brazil.'}, {'ForeName': 'Camila Macêdo Araújo', 'Initials': 'CMA', 'LastName': 'de Medeiros', 'Affiliation': 'Speech-Language Pathology Department, Universidade Federal da Paraíba - UFPB, Cidade Universitária, Conjunto Presidente Castelo Branco III, Brazil.'}, {'ForeName': 'Allan Carlos França', 'Initials': 'ACF', 'LastName': 'da Silva', 'Affiliation': 'Speech-Language Pathology Department, Universidade Federal da Paraíba - UFPB, Cidade Universitária, Conjunto Presidente Castelo Branco III, Brazil.'}, {'ForeName': 'Agostinho Hermes', 'Initials': 'AH', 'LastName': 'de Medeiros Neto', 'Affiliation': 'Internal Medicine Department, Universidade Federal da Paraíba - UFPB, Cidade Universitária, Conjunto Presidente Castelo Branco III, Brazil.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Behlau', 'Affiliation': 'Speech-Language Pathology Department, Universidade Federal de São Paulo - UNIFESP, Brazil.'}]",American journal of speech-language pathology,['10.1044/2022_AJSLP-21-00381']
1867,35701686,Evaluation of Different Doses of the Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy and Its Effect on Villous Trophoblastic Tissue.,"Letrozole, an aromatase inhibitor, has recently been introduced as a favorable medical treatment for ectopic pregnancy. We aimed at evaluating the effects of different doses of letrozole for termination of ectopic pregnancy and study their effects on villous trophoblastic tissue. Sixty patients with undisturbed ectopic pregnancy were classified into three equal groups. Group I: the control group that contained women who underwent laparoscopic salpingectomy, Group II: patients who received letrozole (5 mg day -1 ) for 10 days, and Group III: patients who received letrozole (10 mg day -1 ) for 10 days. Subsequently, the β-hCG levels were determined on the first day and after 11 days of treatment. Group IV consisted of patients of GII and GIII; their β-hCG did not drop below 100 mIU/ml within 11 days, and underwent salpingectomy. Placental tissues from patients undergoing salpingectomy either from the control group or GIV were processed for the evaluation of estrogen (ER) and progesterone (PR) receptors, vascular endothelial growth factor (VEGF), and cleaved caspase 3 (CC-3) expression. Cases exposed to high dose letrozole 10 mg day -1  resulted in a higher ectopic pregnancy resolution rate of 85% (17/20), while the resolution rate of the low dose letrozole-treated group (5 mg day -1 ) was 65% (13/20), and also showed a significant reduction in β-hCG levels on the 11th day, 25.63 ± 4.29 compared to the low dose letrozole group 37.91 ± 7.18 (P < 0.001), Meanwhile, the letrozole-treated group GIV showed markedly reduced expression of ER, PR, and VEGF and a significant increase in the apoptotic index cleaved caspase-3 compared to the control group (P < 0.001). The utilization of letrozole at a dose of 10 mg day -1  for medical treatment of ectopic pregnancy results in a high-successful rate without any severe side effects. Letrozole depriving the placenta of estrogen that had vascular supporting signals resulted in destroying the vascular network with marked apoptosis.",2022,"Cases exposed to high dose letrozole 10 mg day -1  resulted in a higher ectopic pregnancy resolution rate of 85% (17/20), while the resolution rate of the low dose letrozole-treated group (5 mg day -1 ) was 65% (13/20), and also showed a significant reduction in β-hCG levels on the 11th day, 25.63 ± 4.29 compared to the low dose letrozole group 37.91 ± 7.18 (P < 0.001),","['Sixty patients with undisturbed ectopic pregnancy', 'patients undergoing salpingectomy either from the control group or GIV']","['laparoscopic salpingectomy', 'Aromatase Inhibitor Letrozole', 'β-hCG', 'Letrozole', 'letrozole']","['resolution rate', 'ectopic pregnancy resolution rate', 'β-hCG levels', 'apoptotic index cleaved caspase-3', 'evaluation of estrogen (ER) and progesterone (PR) receptors, vascular endothelial growth factor (VEGF), and cleaved caspase 3 (CC-3) expression', 'Villous Trophoblastic Tissue', 'villous trophoblastic tissue', 'expression of ER, PR, and VEGF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032987', 'cui_str': 'Ectopic pregnancy'}, {'cui': 'C0041271', 'cui_str': 'Fallopian tube excision'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1282523', 'cui_str': 'Laparoscopic salpingectomy'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}]","[{'cui': 'C0032987', 'cui_str': 'Ectopic pregnancy'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0291573', 'cui_str': 'Caspase-3'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",60.0,0.0228108,"Cases exposed to high dose letrozole 10 mg day -1  resulted in a higher ectopic pregnancy resolution rate of 85% (17/20), while the resolution rate of the low dose letrozole-treated group (5 mg day -1 ) was 65% (13/20), and also showed a significant reduction in β-hCG levels on the 11th day, 25.63 ± 4.29 compared to the low dose letrozole group 37.91 ± 7.18 (P < 0.001),","[{'ForeName': 'Mohamed Ali', 'Initials': 'MA', 'LastName': 'Alabiad', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt. maabyad@medicine.zu.edu.eg.'}, {'ForeName': 'Warda M M', 'Initials': 'WMM', 'LastName': 'Said', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Benghazi University, Benghazi, Libya.'}, {'ForeName': 'Abdalla Hassan', 'Initials': 'AH', 'LastName': 'Gad', 'Affiliation': 'Department of Gynecology and Obstetrics, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mustafa Taha Abdelfattah', 'Initials': 'MTA', 'LastName': 'Sharaf ElDin', 'Affiliation': 'Department of Gynecology and Obstetrics, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Dina Ahmed', 'Initials': 'DA', 'LastName': 'Khairy', 'Affiliation': 'Department of Biomedical Dental Sciences, College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Mai Ahmed', 'Initials': 'MA', 'LastName': 'Gobran', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt.'}, {'ForeName': 'Amany Mohamed', 'Initials': 'AM', 'LastName': 'Shalaby', 'Affiliation': 'Department of Histology and Cell Biology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Walaa', 'Initials': 'W', 'LastName': 'Samy', 'Affiliation': 'Department of Medical Biochemistry and Molecular Biology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ahmed Ahmed', 'Initials': 'AA', 'LastName': 'Abdelsameea', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ahmed Ismail', 'Initials': 'AI', 'LastName': 'Heraiz', 'Affiliation': 'Department of Gynecology and Obstetrics, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-022-00993-0']
1868,35701639,Cardiotocography combined with ST analysis versus cardiotocography combined with fetal blood sampling in deliveries with abnormal CTG: a randomized trial.,"PURPOSE


The aim was to investigate if intrapartum monitoring with cardiotocography (CTG) in combination with ST analysis (STAN) results in an improved perinatal outcome.
METHODS


We performed a two-center randomized trial. 1013 women with term fetuses in cephalic presentation entered the trial. If a CTG showed intermediate or pathological abnormalities, they were offered fetal blood sampling (FBS) and inclusion if the pH value was above 7.25. They were randomized to either CTG + FBS or CTG + STAN. The primary outcome was neonatal metabolic acidosis, defined as umbilical cord arterial blood pH below 7.05, and base excess equal to or below -10. The secondary outcomes included operative vaginal delivery for fetal distress.
RESULTS


The rate of metabolic acidosis was 0.8% in the CTG + FBS group and 1.5% in women in the CTG + STAN (P = 0.338). More women in the CTG + STAN group delivered by operative vaginal delivery (25.6% vs 33.5%, P = 0.006). Significantly fewer women in the CTG + STAN group had three to five (28.8% vs 11.0%, P =  < 0.001) and six to ten fetal blood samples taken (3.4% vs 0.4%, P =  < 0.001).
CONCLUSION


CTG + STAN did not reduce the incidence of neonatal metabolic acidosis compared to CTG + FBS. CTG + STAN was, however, associated with an increased risk of operative vaginal delivery and a reduced use of FBS. If STAN is used for fetal surveillance, we recommend that it is combined with other methods, such as FBS, for confirmation of the need for operative delivery.
CLINICALTRIALS


gov ID: NCT01699646. Date of registration: October 4, 2012 (retrospectively registered). https://clinicaltrials.gov/ct2/show/NCT01699646?id=NCT01699646&draw=2&rank=1.",2022,"CTG + STAN was, however, associated with an increased risk of operative vaginal delivery and a reduced use of FBS.","['deliveries with abnormal CTG', '1013 women with term fetuses in cephalic presentation entered the trial']","['CTG\u2009+\u2009FBS or CTG\u2009+\u2009STAN', 'Cardiotocography combined with ST analysis versus cardiotocography combined with fetal blood sampling', 'CTG\u2009+\u2009FBS', 'CTG', 'intrapartum monitoring with cardiotocography (CTG']","['operative vaginal delivery for fetal distress', 'incidence of neonatal metabolic acidosis', 'operative vaginal delivery', 'rate of metabolic acidosis', 'neonatal metabolic acidosis, defined as umbilical cord arterial blood pH below 7.05, and base excess equal to or below -10', 'risk of operative vaginal delivery']","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}, {'cui': 'C0419350', 'cui_str': 'Fetal blood sampling'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring fetal status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C0201985', 'cui_str': 'Delta base, blood'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1013.0,0.170501,"CTG + STAN was, however, associated with an increased risk of operative vaginal delivery and a reduced use of FBS.","[{'ForeName': 'Simon Foged', 'Initials': 'SF', 'LastName': 'Victor', 'Affiliation': 'Department of Obstetrics and Gynecology, Zealand University Hospital, Holbæk, Denmark. simonvictor@hotmail.com.'}, {'ForeName': 'Diana Bøttcher Brøndum', 'Initials': 'DBB', 'LastName': 'Bach', 'Affiliation': 'Department of Gynecology and Obstetrics, Copenhagen University Hospital, Amager and Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anna Carolina', 'Initials': 'AC', 'LastName': 'Hvelplund', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital, Amager and Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Nickelsen', 'Affiliation': 'Department of Gynecology and Obstetrics, Copenhagen University Hospital, Amager and Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lyndrup', 'Affiliation': 'Department of Gynecology and Obstetrics, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Wilken-Jensen', 'Affiliation': 'Department of Gynecology and Obstetrics, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Lise Jul', 'Initials': 'LJ', 'LastName': 'Scharff', 'Affiliation': 'Department of Gynecology and Obstetrics, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Department of Gynecology and Obstetrics, Copenhagen University Hospital, Amager and Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Niels Jørgen', 'Initials': 'NJ', 'LastName': 'Secher', 'Affiliation': 'Department of Gynecology and Obstetrics, Copenhagen University Hospital, Amager and Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Krebs', 'Affiliation': 'Department of Gynecology and Obstetrics, Copenhagen University Hospital, Amager and Hvidovre Hospital, Copenhagen, Denmark.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-022-06649-3']
1869,35702086,Effects of high-quality nursing on complications of peripherally inserted central catheter placement in patients with leukemia.,"OBJECTIVE


To determine the effects of high-quality nursing on negative emotions, treatment compliance, and complications of peripherally inserted central catheter (PICC) placement in patients with leukemia.
METHODS


A total of 87 patients with leukemia treated in our hospital from May 2018 to May 2020 were retrospectively enrolled and their clinical data were analyzed. The patients were assigned to a routine group (n=40) and a high-quality group (n=47) based on different nursing schemes. The self-rating depression scale (SDS) and self-rating anxiety scale (SAS) were used to compare the negative emotional changes in patients of the two groups, and the visual analogue scale (VAS) was used to analyze the degree of pain. The two groups were compared in treatment compliance, quality of life, incidence of complications of PICC placement, and nursing satisfaction.
RESULTS


After intervention, the high-quality group got significantly lower SDS and SAS scores than the routine group (both P<0.05). Compared with the routine group, the high-quality group showed higher treatment compliance and nursing satisfaction, experienced higher quality of life (all P<0.05), with also a lower total incidence of complications of PICC placement (P<0.01).
CONCLUSION


For patients with leukemia, high-quality nursing can substantially improve their psychological state, treatment compliance and nursing satisfaction, and reduce the incidence of complications of PICC placement.",2022,"The two groups were compared in treatment compliance, quality of life, incidence of complications of PICC placement, and nursing satisfaction.
","['patients with leukemia', '87 patients with leukemia treated in our hospital from May 2018 to May 2020 were retrospectively enrolled and their clinical data were analyzed']","['high-quality group (n=47) based on different nursing schemes', 'high-quality nursing', 'peripherally inserted central catheter (PICC) placement']","['negative emotional changes', 'self-rating depression scale (SDS) and self-rating anxiety scale (SAS', 'quality of life', 'total incidence of complications of PICC placement', 'visual analogue scale (VAS', 'psychological state, treatment compliance and nursing satisfaction', 'SDS and SAS scores', 'treatment compliance and nursing satisfaction', 'quality of life, incidence of complications of PICC placement, and nursing satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",87.0,0.0173408,"The two groups were compared in treatment compliance, quality of life, incidence of complications of PICC placement, and nursing satisfaction.
","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University Suzhou 215006, Jiangsu, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University Suzhou 215006, Jiangsu, China.'}]",American journal of translational research,[]
1870,34893880,Preliminary Evaluation of Short-Term Abstinence Effects Among Never-Smoking Experienced Users of Modern Electronic Cigarettes.,"INTRODUCTION


ECIG use has increased among non-smokers, with the potential negative consequence of developing nicotine dependence. ECIG users report withdrawal symptoms upon abstinence, though the significance of these symptoms has been questioned. This preliminary study aimed to characterize the early timecourse of ECIG withdrawal under forced abstinence.
METHODS


Fifteen never-smoking ECIG users completed two conditions whereby participants either abstained from ECIG use (abstinence) or used their own ECIG (ad lib) for 3 h. Puff topography in this latter condition was measured via video observation. Outcome measures included heart rate, subjective ratings of withdrawal, cognitive performance, and choice behavior.
RESULTS


Heart rate was lower during abstinence compared to ad lib use (F = 12.60, p < .01, ƞp2 = 0.47). Higher levels of craving (F = 4.98, p < .05, ƞp2 = 0.26) and lower levels of nicotine effects (e.g., dizzy, F = 4.62, p < .05, ƞp2 = 0.36) were reported during abstinence compared to ad lib use. Interaction effects were observed for both factors of the Questionnaire of Smoking Urges: Brief (Fs > 3.56, ps < .05, ƞp2s = 0.21-0.27), with factor scores increasing from baseline to 90 min in the abstinent condition only. Inhibitory control was impaired at 120 min in the abstinent condition only (F = 7.51, p < .05, ƞp2 = 0.50).
CONCLUSIONS


Never-smoking ECIG users experienced aversive withdrawal symptoms within 2-3 h of abstinence. Future work should include other control conditions, such as placebo ECIGs or nicotine replacement therapy, and biomarkers of nicotine exposure, as well as examine withdrawal as a function of device type.
IMPLICATIONS


Never-smoking ECIG users experience some aversive nicotine withdrawal symptoms within two to three hours of abstinence. Relative to ad lib ECIG use, abstinence decreased heart rate and inhibitory control, as well as increased subjective ratings of withdrawal such as craving and intention to vape. Those same symptoms might be suppressed by self-administration of ECIGs. Experiencing withdrawal upon abstinence may indicate that ECIGs can cause dependence without a history of other tobacco use.",2022,"RESULTS


Heart rate was lower during abstinence compared to ad lib use (F = 12.60, p < .01, ƞp2 = 0.47).","['Fifteen never-smoking ECIG users completed two conditions whereby participants either', 'Never-Smoking Experienced Users of Modern Electronic Cigarettes']","['ECIGs', 'ECIG', 'abstained from ECIG use (abstinence) or used their own ECIG (ad lib']","['levels of nicotine effects', 'aversive withdrawal symptoms', 'heart rate, subjective ratings of withdrawal, cognitive performance, and choice behavior', 'Higher levels of craving', 'Heart rate', 'Interaction effects', 'Questionnaire of Smoking Urges', 'factor scores', 'heart rate and inhibitory control', 'subjective ratings of withdrawal such as craving and intention to vape', 'Inhibitory control']","[{'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]",,0.0355728,"RESULTS


Heart rate was lower during abstinence compared to ad lib use (F = 12.60, p < .01, ƞp2 = 0.47).","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Felicione', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Blank', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab252']
1871,35702476,"The Effects of a Pre-workout Supplement on Measures of Alertness, Mood, and Lower-Extremity Power.","Objective The purpose of this study was to investigate the effects of a multi-ingredient pre-workout supplement (MIPS) on mental and physical performance. Materials and methods Fourteen exercise-trained men (n=7) and women (n=7) completed this randomized, placebo-controlled, double-blind, counterbalanced, crossover trial. Participants consumed either a MIPS or a placebo in a randomized, counterbalanced order. Forty-five minutes after consumption, the following assessments were conducted: psychomotor vigilance test (PVT), Profile of Mood States (POMS), vertical jump test, and heart rate and blood pressure. There was a one-week washout period between assessments. Results Statistically significant differences were observed between the treatment and placebo groups for the PVT (reaction time: treatment: 286 ± 28 ms, placebo: 306 ± 46 ms, p=0.0371) and POMS (i.e., vigor: treatment: 15.2 ± 14.9, placebo: 9.7 ± 9.6, p=0.0403; fatigue: treatment: 1.0 ± 1.1, placebo: 3.3 ± 3.4, p=0.0100). There were no significant differences between groups for the other indices of mood, false starts from the PVT, and vertical jump. Conclusion Based on our findings, the acute consumption of a MIPS produced a significant improvement in a sustained-attention, reaction-timed task as well as measures of vigor and fatigue.",2022,"There were no significant differences between groups for the other indices of mood, false starts from the PVT, and vertical jump.",['Materials and methods Fourteen exercise-trained men (n=7) and women (n=7'],"['Pre-workout Supplement', 'MIPS\xa0or a placebo', 'placebo', 'multi-ingredient pre-workout supplement (MIPS']","['sustained-attention, reaction-timed task as well as measures of vigor and fatigue', 'Measures of Alertness, Mood, and Lower-Extremity Power', 'mental and physical performance', 'psychomotor vigilance test (PVT), Profile of Mood States (POMS), vertical jump test, and heart rate and blood pressure']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C4720934', 'cui_str': 'Vertical jump test'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",14.0,0.261958,"There were no significant differences between groups for the other indices of mood, false starts from the PVT, and vertical jump.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': 'Exercise and Sports Science, Keiser University, West Palm Beach, USA.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': 'Nutrition/Exercise and Sports Sciences, Rocky Mountain University of Health Professions, Ft. Lauderdale, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mekhail', 'Affiliation': 'Nutrition/Exercise and Sports Sciences, Nova Southeastern University, Ft. Lauderdale, USA.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Czartoryski', 'Affiliation': 'Nutrition/Exercise and Sports Sciences, Nova Southeastern University, Ft. Lauderdale, USA.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Santana', 'Affiliation': 'Fitness and Performance, Institute of Human Performance, Boca Raton, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Antonio', 'Affiliation': 'College of Health Care Sciences, Nova Southeastern University, Davie, USA.'}]",Cureus,['10.7759/cureus.24877']
1872,35702450,Efficacy of Single Dose of Fosfomycin Versus a Five-Day Course of Ciprofloxacin in Patients With Uncomplicated Urinary Tract Infection.,"INTRODUCTION AND OBJECTIVE


Treatment has become more challenging due to an aging population, polypharmacy and high prevalence of comorbid illness, antimicrobial antibiotic allergy or sensitivity, an increase in the number of individuals with underlying immunological or structural abnormalities, as well as the frequency of multidrug-resistant infections. Many multidrug-resistant bacteria are still susceptible to nitrofurantoin and fosfomycin, two ancient medicines. Their high urine concentrations and low toxicity give them an advantage over newer medications. This study aimed to compare the efficacy of a single dose of fosfomycin versus a five-day course of ciprofloxacin in patients with uncomplicated urinary tract infections. Methodology and data collection procedure: This randomized control trial was conducted in the Department of Medicine, Benazir Bhutto Hospital, Rawalpindi. A total of 46 patients were enrolled. Patients were divided randomly into two groups by using the lottery method. In group A, patients were given a single 3 g dose of oral fosfomycin. In group B, patients were given oral ciprofloxacin (500 mg) daily for five days. Then patients were followed-up in the Outpatient Department (OPD) for 28 days. After 28 days, patients were evaluated for resolution of symptoms (as per operational definition). Patients in whom symptoms would not be resolved were managed as per standard protocol. All this information was recorded on proforma.
RESULTS


The average age of the patients in group A was 39.41±9.80 years while in group B that was 41.32±17.76 years. In both groups, 23 females were equally divided. The mean duration of symptoms in group A was 4.78±1.98 days while in group B was 4.95±1.29 days. The minimum duration of symptoms was three days and the maximum was 10 days. In group A, there were 15 (65.21%) patients with efficacy achieved, and among eight (34.78%) patients, efficacy was not achieved while in group B, there were 15 (65.21%) patients in which efficacy was achieved, and among eight (34.78%) patients, efficacy was not achieved. There was no significant association between efficacy and study groups as the p-value was not significant (p=0.87).  Conclusion: The conclusion of the study was that in the treatment of simple urinary infections, a single dose of fosfomycin had equal efficacy and tolerability as a five-day course of ciprofloxacin.",2022,There was no significant association between efficacy and study groups as the p-value was not significant (p=0.87).  ,"['23 females were equally divided', 'patients with uncomplicated urinary tract infections', '46 patients were enrolled', 'Patients With Uncomplicated Urinary Tract Infection']","['ciprofloxacin', 'oral ciprofloxacin', 'fosfomycin', 'oral fosfomycin', 'Fosfomycin Versus', 'Ciprofloxacin']","['efficacy and tolerability', 'mean duration of symptoms', 'minimum duration of symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}]",46.0,0.0160262,There was no significant association between efficacy and study groups as the p-value was not significant (p=0.87).  ,"[{'ForeName': 'Muhammad Mujeeb', 'Initials': 'MM', 'LastName': 'Hassan', 'Affiliation': 'Department of Internal Medicine, Rawalpindi Medical University, Rawalpindi, PAK.'}, {'ForeName': 'Moeena', 'Initials': 'M', 'LastName': 'Malik', 'Affiliation': 'Department of Internal Medicine, Rawalpindi Medical University, Rawalpindi, PAK.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Saleem', 'Affiliation': 'Department of Obstetrics and Gynecology, Rawalpindi Medical University, Rawalpindi, PAK.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Saleem', 'Affiliation': 'Department of Pediatrics and Child Health, Islamic International Medical College (IIMCT) Pakistan Railway Hospital, Rawalpindi, PAK.'}, {'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Zohaib', 'Affiliation': 'Department of Internal Medicine, Rawalpindi Medical University, Rawalpindi, PAK.'}, {'ForeName': 'Adnan Younas', 'Initials': 'AY', 'LastName': 'Malik', 'Affiliation': 'Department of Internal Medicine and Nephrology, Rawalpindi Medical University, Rawalpindi, PAK.'}, {'ForeName': 'Maham', 'Initials': 'M', 'LastName': 'Javaid', 'Affiliation': 'Department of Internal Medicine, Allama Iqbal Medical College, Lahore, PAK.'}]",Cureus,['10.7759/cureus.24843']
1873,35702414,Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial.,"Background


Geographic location and national income may influence access to innovation in healthcare. We aimed to study if geographical location and national income influenced the timelines to activate the global phase III APHINITY trial, evaluating adjuvant pertuzumab in patients with HER2-positive early breast cancer.
Methods


Time from regulatory authority (RA) submission to approval (RAA), time to Ethics Committee/Institutional Review Board (EC/IRB) approval, time from study approval by EC/IRB to first randomised patient and from first to last randomised patient were collected. Analyses were conducted grouping countries by geographical region or economic income classification.
Results


Forty-one countries (of 42) had data available regarding all relevant timelines. No statistical difference was observed between the time to RAA and geographical region ( p  = 0.47), although there was a trend to longer time to RAA in upper middle-income economies ( p  = 0.07). Except for time from first to last patient randomised, there was wide variation in timelines overall and within geographical regions and economic income groups.
Conclusions


Geographical location and income classification did not appear to be the major drivers influencing time for clinical trial activation. Wide variability in activation timelines within geographical regions and income groups exists and is worthy of further investigation.",2022,"No statistical difference was observed between the time to RAA and geographical region ( p  = 0.47), although there was a trend to longer time to RAA in upper middle-income economies ( p  = 0.07).",['patients with HER2-positive early breast cancer'],[],['time to RAA and geographical region'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.242765,"No statistical difference was observed between the time to RAA and geographical region ( p  = 0.47), although there was a trend to longer time to RAA in upper middle-income economies ( p  = 0.07).","[{'ForeName': 'Maria Alice', 'Initials': 'MA', 'LastName': 'Franzoi', 'Affiliation': 'Clinical Trials Support Unit, Jules Bordet Institute, Brussels, Belgium.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Procter', 'Affiliation': 'Frontier Science Scotland Ltd, Kincraig, Kingussie, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': 'University of Leeds and Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Ponde', 'Affiliation': 'AC Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eiger', 'Affiliation': 'F Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Orianne', 'Initials': 'O', 'LastName': 'Emond', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clark', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Parlier', 'Affiliation': 'Clinical Trials Support Unit, Jules Bordet Institute, Brussels, Belgium.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Guillaume', 'Affiliation': 'Clinical Trials Support Unit, Jules Bordet Institute, Brussels, Belgium.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Reaby', 'Affiliation': 'Patient Representative, Newcastle, Australia.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'Clinical Trials Support Unit, Jules Bordet Institute, Brussels, Belgium.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Bines', 'Affiliation': 'Instituto Nacional de Câncer, INCA, Rio de Janeiro, Brazil.'}]",Ecancermedicalscience,['10.3332/ecancer.2022.1379']
1874,35702350,"Early Titration of Oxygen During Mechanical Ventilation Reduces Hyperoxemia in a Pilot, Feasibility, Randomized Control Trial for Automated Titration of Oxygen Levels.","Timely regulation of oxygen (Fio 2 ) is essential to prevent hyperoxemia or episodic hypoxemia. Exposure to excessive Fio 2  is often noted early after onset of mechanical ventilation. In this pilot study, we examined the feasibility, safety, and efficacy of a clinical trial to prioritize Fio 2  titration with electronic alerts to respiratory therapists.
STUDY DESIGN


Open-labeled, randomized control pilot trial.
SETTING


Medical ICU.
SUBJECTS


Adults requiring mechanical ventilation.
INTERVENTIONS


Protocolized oxygen titration was initiated one hour after initiation of mechanical ventilation. When Spo 2  exceeded 92% while on Fio 2  ≥ 0.5, an electronic alert to respiratory therapists was triggered at 30-minute intervals. In the control arm, respiratory therapists titrated Fio 2  by standard physician's orders.
MEASUREMENTS AND MAIN RESULTS


The primary end point was to determine if early Fio 2  titration based on automated alerts was feasible in terms of reducing hyperoxemia. Secondary analyses included the number and frequency of alerts, mechanical ventilation duration, and ICU length of stay. Among 135 randomized patients, 72 were assigned to the intervention arm and 63 to the control arm. A total 877 alerts were sent. Exposure to hyperoxemia was significantly reduced in the intervention group by a median of 7.5 hours (13.7 [interquartile range (IQR), 2.9-31.1] vs 21.2 [IQR, 10.9-64.4];  p  < 0.0004). Maximal Fio 2  titration during the first quartile resulted in significant reduction in mechanical ventilation duration and ICU stay. Minor hypoxemic events (Spo 2  < 88%) represented 12% of alerts, 9% were transient and responded to a single Fio 2  increase, whereas 3% of alerts were associated with recurrent transient hypoxemia.
CONCLUSIONS


Our pilot study indicates that early Fio 2  titration driven by automated alerts is feasible in the ICU, as reflected by a statistically significant reduction of hyperoxemia exposure, limited consequential hypoxemia, and reduced ICU resource utilization. The encouraging results of this pilot study need to be validated in a larger ICU cohort.",2022,Maximal Fio 2  titration during the first quartile resulted in significant reduction in mechanical ventilation duration and ICU stay.,"['Adults requiring mechanical ventilation', 'A total 877 alerts were sent']","['Protocolized oxygen titration', 'Oxygen']","['number and frequency of alerts, mechanical ventilation duration, and ICU length of stay', 'Exposure to hyperoxemia', 'feasibility, safety, and efficacy', 'mechanical ventilation duration and ICU stay', 'recurrent transient hypoxemia', 'Minor hypoxemic events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",877.0,0.0681945,Maximal Fio 2  titration during the first quartile resulted in significant reduction in mechanical ventilation duration and ICU stay.,"[{'ForeName': 'Sonal R', 'Initials': 'SR', 'LastName': 'Pannu', 'Affiliation': 'Division of Pulmonary, Critical Care & Sleep Medicine, Department of Internal Medicine, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Exline', 'Affiliation': 'Division of Pulmonary, Critical Care & Sleep Medicine, Department of Internal Medicine, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Klamer', 'Affiliation': 'Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Brock', 'Affiliation': 'Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Elliott D', 'Initials': 'ED', 'LastName': 'Crouser', 'Affiliation': 'Division of Pulmonary, Critical Care & Sleep Medicine, Department of Internal Medicine, The Ohio State University, Columbus, OH.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Christman', 'Affiliation': 'Division of Pulmonary, Critical Care & Sleep Medicine, Department of Internal Medicine, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Diaz', 'Affiliation': 'Division of Pulmonary, Critical Care & Sleep Medicine, Department of Internal Medicine, The Ohio State University, Columbus, OH.'}]",Critical care explorations,['10.1097/CCE.0000000000000704']
1875,35699170,Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD.,"Background Despite high female prevalence of peripheral artery disease (PAD), little is known about sex-based outcomes after lower extremity revascularization (LER) for symptomatic PAD. The effects of rivaroxaban according to sex following LER have not been fully reported. Methods and Results In VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease), low-dose rivaroxaban versus placebo on a background of aspirin reduced the composite primary efficacy outcome of cardiovascular and limb events in patients with PAD undergoing LER. Unplanned index limb revascularization was prespecified and prospectively ascertained. The primary safety outcome was Thrombolysis in Myocardial Infarction major bleeding. Analyses of outcomes and treatment effects by sex were performed using Cox proportional hazards models. Among 6564 randomly assigned patients followed for a median of 28 months, 1704 (26.0%) were women. Among patients administered placebo, women were at similar risk for the primary efficacy outcome (hazard ratio [HR], 0.90; [95% CI, 0.74-1.09];  P =0.29) as men, while female sex was associated with a trend toward higher risk of unplanned index limb revascularization (HR, 1.18; [95% CI, 1.00-1.40];  P =0.0499). Irrespective of sex, effects of rivaroxaban were consistent for the primary efficacy outcome ( P -interaction=0.22), unplanned index limb revascularization ( P -interaction=0.64), and bleeding ( P -interaction=0.61). Women were more likely than men to discontinue study treatment (HR, 1.13; [95% CI, 1.03-1.25];  P =0.0099). Conclusions Among >1700 women with PAD undergoing LER, women and men were at similar risk for the primary outcome, but a trend for greater risk of unplanned index limb revascularization among women was observed. Effects of rivaroxaban were consistent by sex, though women more often discontinued treatment. Better understanding of sex-based outcomes and treatment adherence following LER is needed. Registration URL: http://clinicaltrials.gov; Unique identifier: NCT02504216.",2022,"Women were more likely than men to discontinue study treatment (HR, 1.13; [95% CI, 1.03-1.25];  P =0.0099).","['Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease', '1700 women with PAD undergoing LER, women and men', '6564 randomly assigned patients followed for a median of 28\u2009months, 1704 (26.0%) were women', 'patients with PAD undergoing LER']","['rivaroxaban', 'acetylsalicylic acid', 'ASA', 'Rivaroxaban', 'placebo']","['risk of unplanned index limb revascularization', 'Myocardial Infarction major bleeding', 'Unplanned index limb revascularization', 'cardiovascular and limb events', 'unplanned index limb revascularization']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0472662', 'cui_str': 'Limb revascularization'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0472662', 'cui_str': 'Limb revascularization'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",6564.0,0.284274,"Women were more likely than men to discontinue study treatment (HR, 1.13; [95% CI, 1.03-1.25];  P =0.0099).","[{'ForeName': 'Connie N', 'Initials': 'CN', 'LastName': 'Hess', 'Affiliation': 'Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Division of Angiology, Swiss Cardiovascular Center, Inselspital, Bern University Hospital University of Bern Switzerland.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences McMaster University Hamilton Ontario Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nehler', 'Affiliation': 'CPC Clinical Research Aurora CO.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Duke Clinical Research Institute Duke University Medical Center Durham NC.'}, {'ForeName': 'E Sebastian', 'Initials': 'ES', 'LastName': 'Debus', 'Affiliation': 'Department of Vascular Medicine, Vascular Surgery - Angiology - Endovascular Therapy University of Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Capell', 'Affiliation': 'CPC Clinical Research Aurora CO.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'Bayer AG, Research & Development Wuppertal Germany.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'CPC Clinical Research Aurora CO.'}, {'ForeName': 'Lloyd P', 'Initials': 'LP', 'LastName': 'Haskell', 'Affiliation': 'Janssen Research and Development Raritan NJ.'}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Bauersachs', 'Affiliation': 'CCB-Cardiovascular Center Bethanien Frankfurt Germany.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hsia', 'Affiliation': 'Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.024655']
1876,35699143,Does he see what she sees? The gender gap in perceptions of institutional sexism.,"Women are more likely than men to perceive institutional sexism. In the present study, we examined the gender gap in perceptions of a legal case in which a female plaintiff claims she was a victim of institutional gender discrimination by an employer. Participants were randomly assigned to receive information about institutional forms of sexism (or not) prior to learning the facts of the case. In addition, participants were randomly assigned to take the female plaintiff's perspective (or remain objective) while reviewing the case. In isolation, sexism awareness and perspective-taking both independently eliminated the gender gap in perceptions of discrimination. However, contrary to expectations, the gender gap reemerged among participants who were made aware of sexism prior to perspective-taking such that women perceived more discrimination than men. Implications for interventions to increase perceptions of institutional sexism are discussed.",2022,"However, contrary to expectations, the gender gap reemerged among participants who were made aware of sexism prior to perspective-taking such that women perceived more discrimination than men.",['gender gap in perceptions of a legal case in which a female plaintiff claims she was a victim of institutional gender discrimination by an employer'],['information about institutional forms of sexism (or not) prior to learning the facts of the case'],[],"[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0282409', 'cui_str': 'Legal Cases'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C1274022', 'cui_str': 'Employer'}]","[{'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205906', 'cui_str': 'Gender Bias'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",[],,0.0964756,"However, contrary to expectations, the gender gap reemerged among participants who were made aware of sexism prior to perspective-taking such that women perceived more discrimination than men.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Simon', 'Affiliation': 'Siena College.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Soilleux', 'Affiliation': 'Nuance Neuropsychology.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Wyland', 'Affiliation': 'Tulane University.'}, {'ForeName': 'Laurie T', 'Initials': 'LT', 'LastName': ""O'Brien"", 'Affiliation': 'Tulane University.'}]",The Journal of social psychology,['10.1080/00224545.2022.2085543']
1877,35699135,Cognitive bias modification for paranoia (CBM-pa): a randomised controlled feasibility study in patients with distressing paranoid beliefs.,"BACKGROUND


Cognitive Bias Modification for paranoia (CBM-pa) is a novel, theory-driven psychological intervention targeting the biased interpretation of emotional ambiguity associated with paranoia. Study objectives were (i) test the intervention's feasibility, (ii) provide effect size estimates, (iii) assess dose-response and (iv) select primary outcomes for future trials.
METHODS


In a double-blind randomised controlled trial, sixty-three outpatients with clinically significant paranoia were randomised to either CBM-pa or an active control (text reading) between April 2016 and September 2017. Patients received one 40 min session per week for 6 weeks. Assessments were given at baseline, after each interim session, post-treatment, and at 1- and 3-months post-treatment.
RESULTS


A total of 122 patients were screened and 63 were randomised. The recruitment rate was 51.2%, with few dropouts (four out of 63) and follow-up rates were 90.5% (1-month) and 93.7% (3-months). Each session took 30-40 min to complete. There was no statistical evidence of harmful effects of the intervention. Preliminary data were consistent with efficacy of CBM-pa over text-reading control: patients randomised to the intervention, compared to control patients, reported reduced interpretation bias ( d  = -0.48 to -0.76), improved symptoms of paranoia ( d  = -0.19 to -0.38), and lower depressed and anxious mood ( d  = -0.03 to -0.29). The intervention effect was evident after the third session.
CONCLUSIONS


CBM-pa is feasible for patients with paranoia. A fully powered randomised control trial is warranted.",2022,"Preliminary data were consistent with efficacy of CBM-pa over text-reading control: patients randomised to the intervention, compared to control patients, reported reduced interpretation bias ( d  = -0.48 to -0.76), improved symptoms of paranoia ( d  = -0.19 to -0.38), and lower depressed and anxious mood (","['patients with paranoia', 'patients with distressing paranoid beliefs', 'sixty-three outpatients with clinically significant paranoia', 'A total of 122 patients were screened and 63 were randomised']","['CBM-pa or an active control (text reading', 'Cognitive bias modification for paranoia (CBM-pa']","['anxious mood ', 'recruitment rate', 'symptoms of paranoia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C2239195', 'cui_str': 'Anxious mood'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}]",63.0,0.267467,"Preliminary data were consistent with efficacy of CBM-pa over text-reading control: patients randomised to the intervention, compared to control patients, reported reduced interpretation bias ( d  = -0.48 to -0.76), improved symptoms of paranoia ( d  = -0.19 to -0.38), and lower depressed and anxious mood (","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Yiend', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Charlene L M', 'Initials': 'CLM', 'LastName': 'Lam', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Schmidt', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Crane', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Heslin', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kabir', 'Affiliation': 'The McPin Foundation, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Meek', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Mouchlianitis', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stahl', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Trotta', 'Affiliation': 'Laboratory of Clinical Psychology and Affective Neuroscience, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Sukhwinder', 'Initials': 'S', 'LastName': 'Shergill', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience at King's College London, London, UK.""}]",Psychological medicine,['10.1017/S0033291722001520']
1878,35699610,Patient navigation to address sociolegal barriers for patients with cancer: A comparative-effectiveness study.,"BACKGROUND


Sociolegal barriers to cancer care are defined as health-related social needs like affordable healthy housing, stable utility service, and food security that may be remedied by public policy, law, regulation, or programming. Legal support has not been studied in cancer care.
METHODS


The authors conducted a randomized controlled trial of patients who had newly diagnosed cancer at a safety-net medical center in Boston from 2014 through 2017, comparing standard patient navigation versus enhanced navigation partnered with legal advocates to identify and address sociolegal barriers. English-speaking, Spanish-speaking, or Haitian Creole-speaking patients with breast and lung cancer were eligible within 30 days of diagnosis. The primary outcome was timely treatment within 90 days of diagnosis. Secondary outcomes included patient-reported outcomes (distress, cancer-related needs, and satisfaction with navigation) at baseline and at 6 months.
RESULTS


In total, 201 patients with breast cancer and 19 with lung cancer enrolled (response rate, 78%). The mean patient age was 55 years, 51% of patients were Black and 22% were Hispanic, 20% spoke Spanish and 8% spoke Haitian Creole, 73% had public health insurance, 77% reported 1 or more perceived sociolegal barrier, and the most common were barriers to housing and employment. Ninety-six percent of participants with breast cancer and 73% of those with lung cancer initiated treatment within 90 days. No significant effect of enhanced navigation was observed on the receipt of timely treatment among participants with breast cancer (odds ratio, 0.88; 95% CI, 0.17-4.52) or among those with lung cancer (odds ratio, 4.00; 95% CI, 0.35-45.4). No differences in patient-reported outcomes were observed between treatment groups.
CONCLUSIONS


Navigation enhanced by access to legal consultation and support had no impact on timely treatment, patient distress, or patient needs. Although most patients reported sociolegal barriers, few required intensive legal services that could not be addressed by navigators.
LAY SUMMARY


In patients with cancer, the experience of sociolegal barriers to care, such as unstable housing, utility services, or food insecurity, is discussed. Addressing these barriers through legal information and assistance may improve care. This study compares standard patient navigation versus enhanced navigation partnered with legal advocates for patients with breast and lung cancers. Almost all patients in both navigation groups received timely care and also reported the same levels of distress, needs, and satisfaction with navigation. Although 75% of patients in the study had at least 1 sociolegal barrier identified, few required legal advocacy beyond what a navigator who received legal information and coaching could provide.",2022,"Almost all patients in both navigation groups received timely care and also reported the same levels of distress, needs, and satisfaction with navigation.","['English-speaking, Spanish-speaking, or Haitian Creole-speaking patients with breast and lung cancer', 'The mean patient age was 55 years, 51% of patients were Black and 22% were Hispanic, 20% spoke Spanish and 8% spoke Haitian Creole, 73% had public health insurance, 77% reported 1 or more perceived sociolegal barrier, and the most common were barriers to housing and employment', 'patients who had newly diagnosed cancer at a safety-net medical center in Boston from 2014 through 2017, comparing', '201 patients with breast cancer and 19 with lung cancer enrolled (response rate, 78', 'patients with breast and lung cancers', 'patients with cancer']","['standard patient navigation versus enhanced navigation partnered with legal advocates to identify and address sociolegal barriers', 'Patient navigation', 'standard patient navigation versus enhanced navigation partnered with legal advocates']","['patient-reported outcomes (distress, cancer-related needs, and satisfaction with navigation', 'timely treatment within 90 days of diagnosis', 'enhanced navigation']","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",201.0,0.345473,"Almost all patients in both navigation groups received timely care and also reported the same levels of distress, needs, and satisfaction with navigation.","[{'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Battaglia', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Evans Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Gunn', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Evans Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Bak', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Evans Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'JoHanna', 'Initials': 'J', 'LastName': 'Flacks', 'Affiliation': 'Medical-Legal Partnership, Boston (MLPB), Boston, Massachusetts.'}, {'ForeName': 'Kerrie P', 'Initials': 'KP', 'LastName': 'Nelson', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Naomi Y', 'Initials': 'NY', 'LastName': 'Ko', 'Affiliation': 'Department of Medicine, Hematology, and Medical Oncology, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Morton', 'Affiliation': 'Medical-Legal Partnership, Boston (MLPB), Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.33965']
1879,35699476,Growth-Mindset Intervention Delivered by Teachers Boosts Achievement in Early Adolescence.,"School underachievement is a persistent problem in the United States. Direct-to-student, computer-delivered growth-mindset interventions have shown promise as a way to improve achievement for students at risk of failing in school; however, these interventions benefit only students who happen to be in classrooms that support growth-mindset beliefs. Here, we tested a teacher-delivered growth-mindset intervention for U.S. adolescents in Grades 6 and 7 that was designed to both impart growth-mindset beliefs and create a supportive classroom environment where those beliefs could flourish ( N  = 1,996 students,  N  = 50 teachers). The intervention improved the grades of struggling students in the target class by 0.27 standard deviations, or 2.81 grade percentage points. The effects were largest for students whose teachers endorsed fixed mindsets before the intervention. This large-scale, randomized controlled trial demonstrates that growth-mindset interventions can produce gains when delivered by teachers.",2022,"The intervention improved the grades of struggling students in the target class by 0.27 standard deviations, or 2.81 grade percentage points.",['students at risk of failing in school'],"['growth-mindset interventions', 'teacher-delivered growth-mindset intervention', 'Growth-Mindset Intervention', 'Direct-to-student, computer-delivered growth-mindset interventions']",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009622', 'cui_str': 'Computer'}]",[],,0.0525141,"The intervention improved the grades of struggling students in the target class by 0.27 standard deviations, or 2.81 grade percentage points.","[{'ForeName': 'Tenelle', 'Initials': 'T', 'LastName': 'Porter', 'Affiliation': 'Department of Human Ecology, University of California, Davis.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Catalán Molina', 'Affiliation': 'Department of Human Ecology, University of California, Davis.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Cimpian', 'Affiliation': 'Department of Psychology, New York University.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': 'Mindset Works, New York, New York.'}, {'ForeName': 'Afiya', 'Initials': 'A', 'LastName': 'Fredericks', 'Affiliation': 'Department of Psychology, University of the District of Columbia.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Blackwell', 'Affiliation': 'Mindset Works, New York, New York.'}, {'ForeName': 'Kali', 'Initials': 'K', 'LastName': 'Trzesniewski', 'Affiliation': 'Department of Human Ecology, University of California, Davis.'}]",Psychological science,['10.1177/09567976211061109']
1880,35699416,Single versus multiple arterial grafting in diabetic patients at 10 years: the Arterial Revascularization Trial.,"AIMS


To evaluate the impact of multiple arterial grafting (MAG) vs. single arterial grafting (SAG) in a post hoc analysis of 10-year outcomes in patients with diabetes mellitus (DM) from the Arterial Revascularization Trial (ART).
METHODS AND RESULTS


The primary endpoint was all-cause mortality and the secondary endpoint was a composite of major adverse cardiac events (MACE) at 10-year follow-up. Patients were stratified by diabetes status (non-DM and DM) and grafting strategy (MAG vs. SAG). A total of 3020 patients were included in the analysis; 716 (23.7%) had DM. Overall, 55.8% non-DM patients received MAG and 44.2% received SAG, while 56.6% DM patients received MAG and 43.4% received SAG. The use of MAG compared with SAG was associated with lower 10-year mortality for both non-DM [17.7 vs. 21.0%, adjusted hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.72-1.06] and DM patients (21.5 vs. 29.9%, adjusted HR 0.65, 95% CI 0.48-0.89; P for interaction = 0.12). For both groups, the rate of 10-year MACE was also lower for MAG vs. SAG. Overall, deep sternal wound infections (DSWIs) were uncommon but more frequent in the MAG vs. SAG group in both non-DM (3.3 vs. 2.1%) and DM patients (7.9 vs. 4.8%). The highest rates of DSWI were in insulin-treated patients receiving MAG (9.6 vs. 6.3%, when compared with SAG).
CONCLUSION


In this post hoc analysis of the ART, MAG was associated with substantially lower mortality rates at 10 years after coronary artery bypass grafting in patients with DM. Patients with DM receiving MAG had a higher incidence of DSWI, especially if insulin dependent.",2022,"Overall, deep sternal wound infections (DSWIs) were uncommon but more frequent in the MAG vs. SAG group in both non-DM (3.3 vs. 2.1%) and DM patients (7.9 vs. 4.8%).","['diabetic patients at 10 years', 'Patients were stratified by diabetes status (non-DM and DM) and grafting strategy (MAG vs. SAG', 'A total of 3020 patients were included in the analysis; 716 (23.7%) had DM', 'Patients with DM receiving', 'patients with diabetes mellitus (DM) from the Arterial Revascularization Trial (ART']","['multiple arterial grafting', 'MAG vs. SAG', 'MAG', 'multiple arterial grafting (MAG) vs. single arterial grafting (SAG', 'SAG']","['Overall, deep sternal wound infections (DSWIs', 'mortality rates', 'rate of 10-year MACE', 'composite of major adverse cardiac events (MACE', 'highest rates of DSWI', 'cause mortality', '10-year mortality']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450140', 'cui_str': 'Arterial graft'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450140', 'cui_str': 'Arterial graft'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205250', 'cui_str': 'High'}]",3020.0,0.136892,"Overall, deep sternal wound infections (DSWIs) were uncommon but more frequent in the MAG vs. SAG group in both non-DM (3.3 vs. 2.1%) and DM patients (7.9 vs. 4.8%).","[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Taggart', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Audisio', 'Affiliation': 'Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York City, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'N Bryce', 'Initials': 'NB', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York City, NY, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Rahouma', 'Affiliation': 'Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York City, NY, USA.'}, {'ForeName': 'Giovanni Jr', 'Initials': 'GJ', 'LastName': 'Soletti', 'Affiliation': 'Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York City, NY, USA.'}, {'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Cancelli', 'Affiliation': 'Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York City, NY, USA.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'Bristol Heart Institute, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Lees', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Stefil', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gaudino', 'Affiliation': 'Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York City, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehac199']
1881,35699708,Effect of Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care on Self-harm Among Adults With Suicidal Ideation-Reply.,,2022,,['Adults With Suicidal Ideation-Reply'],['Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care'],['Self-harm'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]",,0.00399011,,"[{'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Richards', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Boggs', 'Affiliation': 'Kaiser Permanente Colorado Institute for Health Research, Denver.'}]",JAMA,['10.1001/jama.2022.5883']
1882,35699705,Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial.,"Importance


African American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the US, and effective treatment is needed for all smoking levels.
Objectives


To evaluate the efficacy of varenicline vs placebo among African American adults who are light, moderate, and heavy daily smokers.
Design, Setting, and Participants


The Kick It at Swope IV (KIS-IV) trial was a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City. A total of 500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015 to December 2017; final follow-up was completed in June 2018.
Interventions


Participants were provided 6 sessions of culturally relevant individualized counseling and were randomized (in a 3:2 ratio) to receive varenicline (1 mg twice daily; n = 300) or placebo (n = 200) for 12 weeks. Randomization was stratified by sex and smoking level (1-10 cigarettes/d [light smokers] or >10 cigarettes/d [moderate to heavy smokers]).
Main Outcomes and Measures


The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26. The secondary outcome was 7-day point prevalence smoking abstinence at week 12, with subgroup analyses for light smokers (1-10 cigarettes/d) and moderate to heavy smokers (>10 cigarettes/d).
Results


Among 500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users), 441 (88%) completed the trial. Treating those lost to follow-up as smokers, participants receiving varenicline were significantly more likely than those receiving placebo to be abstinent at week 26 (15.7% vs 6.5%; difference, 9.2% [95% CI, 3.8%-14.5%]; odds ratio [OR], 2.7 [95% CI, 1.4-5.1]; P = .002). The varenicline group also demonstrated greater abstinence than the placebo group at the end of treatment week 12 (18.7% vs 7.0%; difference, 11.7% [95% CI, 6.0%-17.7%]; OR, 3.0 [95% CI, 1.7-5.6]; P < .001). Smoking abstinence at week 12 was significantly greater for individuals receiving varenicline compared with placebo among light smokers (22.1% vs 8.5%; difference, 13.6% [95% CI, 5.2%-22.0%]; OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96). Medication adverse events were generally comparable between treatment groups, with nausea reported more frequently in the varenicline group (163 of 293 [55.6%]) than the placebo group (90 of 196 [45.9%]).
Conclusions and Relevance


Among African American adults who are daily smokers, varenicline added to counseling resulted in a statistically significant improvement in the rates of 7-day point prevalence smoking abstinence at week 26 compared with counseling and placebo. The findings support the use of varenicline in addition to counseling for tobacco use treatment among African American adults who are daily smokers.
Trial Registration


ClinicalTrials.gov Identifier: NCT02360631.",2022,"OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96).","['500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users), 441 (88%) completed the trial', '500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015 to December 2017; final follow-up was completed in June 2018', 'African American smokers', 'federally qualified health center in Kansas City', 'African American adults who are daily smokers', 'African American Daily Smokers', 'African American adults who are light, moderate, and heavy daily smokers']","['varenicline', 'culturally relevant individualized counseling', 'varenicline vs placebo', 'Varenicline', 'placebo']","['7-day point prevalence smoking abstinence', 'greater abstinence', 'rates of 7-day point prevalence smoking abstinence', 'salivary cotinine-verified 7-day point prevalence smoking abstinence', 'Medication adverse events', 'Smoking abstinence', 'nausea', 'Smoking Cessation']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C3494624', 'cui_str': 'Light tobacco smoker'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",500.0,0.596701,"OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96).","[{'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'University of Kansas Cancer Center, Kansas City.'}, {'ForeName': 'Babalola', 'Initials': 'B', 'LastName': 'Faseru', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Greiner', 'Affiliation': 'Department of Family Medicine, University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Krebill', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Tyndale', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.'}]",JAMA,['10.1001/jama.2022.8274']
1883,35699674,Effect of the Personal Protective Equipment Donning and Doffing Program for Nurses in Military Hospitals.,"This study aimed to develop and verify the effect of a new personal protective equipment donning and doffing program for nurses in military hospitals. A total of 40 nurses (20 experimental group, 20 control group) participated in this non-equivalent control group experimental study. The new program consisted of the description of the design modification of the inner and outer boundary marks of coveralls and a video with verbal instructions and footswitch that the participants could watch at their own pace. Data collection was carried out before, immediately after, and two weeks after the intervention. The effects of the program on accuracy, self-efficacy, and time were analyzed using a generalized estimating equation. PPE donning and doffing accuracy, self-efficacy, and time were significantly increased in the experimental group compared to those in the control group, both immediately after and two weeks after intervention. As this program has been confirmed to be effective in improving PPE donning and doffing accuracy and self-efficacy, we recommend to use this program for training nurses on donning and doffing of PPE.",2022,"PPE donning and doffing accuracy, self-efficacy, and time were significantly increased in the experimental group compared to those in the control group, both immediately after and two weeks after intervention.","['Nurses in Military Hospitals', 'nurses in military hospitals', '40 nurses (20 experimental group, 20 control group) participated in this non-equivalent control group experimental study']","['Personal Protective Equipment Donning and Doffing Program', 'new personal protective equipment donning and doffing program']","['accuracy, self-efficacy, and time', 'PPE donning and doffing accuracy, self-efficacy, and time']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",40.0,0.0120429,"PPE donning and doffing accuracy, self-efficacy, and time were significantly increased in the experimental group compared to those in the control group, both immediately after and two weeks after intervention.","[{'ForeName': 'Hyewon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Armed Forces Capital Hospital, 81, Saemaeul-ro 177beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Ihn Sook', 'Initials': 'IS', 'LastName': 'Jeong', 'Affiliation': 'College of Nursing, Pusan National University 49 Busandaehak-ro Mulgeum-eup Yangsan-si Gyeongsangnam-do, South Korea.'}]",Nursing & health sciences,['10.1111/nhs.12966']
1884,35700073,Total Hip Arthroplasty Leads to Better Results After Low-Energy Displaced Femoral Neck Fracture in Patients Aged 55 to 70 Years: A Randomized Controlled Multicenter Trial Comparing Internal Fixation and Total Hip Arthroplasty.,"BACKGROUND


The optimal treatment of displaced femoral neck fractures in patients 55 to 70 years old remains controversial. The aim of the present study was to assess the effect of closed reduction and internal fixation with cannulated screws (IF) compared with total hip arthroplasty (THA) on hip pain and function, with use of data for outcome measures, complications, and reoperations.
METHODS


This multicenter randomized controlled trial included all patients 55 to 70 years old who presented with a low-energy displaced femoral neck fracture between December 2013 and December 2018. Patients were randomly allocated to undergo either IF or THA. The primary outcome was the Harris Hip Score (HHS) at 12 months postoperatively. Secondary outcomes were the HHS at 4 and 24 months postoperatively, Oxford Hip Score (OHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), health-related quality of life (EQ-5D-3L [EuroQol 5 Dimensions 3 Levels] index score and EQ-VAS [visual analogue scale]), VAS for pain, and VAS for patient satisfaction at 4, 12, and 24 months postoperatively. Complications and reoperations were continuously monitored. The primary analyses were performed according to the intention-to-treat principle.
RESULTS


A total of 102 patients with a mean (± standard deviation) age of 63.7 ± 4.2 years were allocated to IF (n = 51) or THA (n = 51). The mean difference in the primary outcome, the HHS at 12 months postoperatively (5.3; 95% confidence interval, 0.9 to 9.7; p = 0.017), was below the predefined minimal clinically important difference of 10 points. However, patients who underwent THA had a significantly higher HHS at 4 and 12 months, better OHS at 4 and 12 months, and better HOOS at 4, 12, and 24 months postoperatively. Patients who underwent THA also reported better health-related quality of life at 4 months postoperatively and reported greater satisfaction and less pain at 4 and 12 months postoperatively. A total of 26 patients in the IF group (51%; 95% confidence interval, 37% to 65%) and 2 patients in the THA group (4%; 95% confidence interval, 0.5% to 13%) underwent a major reoperation.
CONCLUSIONS


In this randomized controlled trial, we showed that patients between 55 and 70 years old who underwent THA for a low-energy displaced femoral neck fracture experienced better outcomes than those who underwent closed reduction and internal fixation.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2022,Patients who underwent THA also reported better health-related quality of life at 4 months postoperatively and reported greater satisfaction and less pain at 4 and 12 months postoperatively.,"['102 patients with a mean (± standard deviation) age of 63.7 ± 4.2 years', 'Patients Aged 55 to 70 Years', 'displaced femoral neck fractures in patients 55 to 70 years old remains controversial', 'patients between 55 and 70 years old who underwent THA for a low-energy displaced femoral neck fracture experienced better outcomes than those who underwent closed reduction and internal fixation', 'patients 55 to 70 years old who presented with a low-energy displaced femoral neck fracture between December 2013 and December 2018']","['IF or THA', 'closed reduction and internal fixation with cannulated screws (IF', 'Low-Energy Displaced Femoral Neck Fracture', 'THA', 'Internal Fixation and Total Hip Arthroplasty', 'total hip arthroplasty (THA']","['HHS', 'health-related quality of life', 'satisfaction and less pain', 'Harris Hip Score (HHS', 'HHS at 4 and 24 months postoperatively, Oxford Hip Score (OHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), health-related quality of life (EQ-5D-3L [EuroQol 5 Dimensions 3 Levels] index score and EQ-VAS [visual analogue scale]), VAS for pain, and VAS for patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",102.0,0.130672,Patients who underwent THA also reported better health-related quality of life at 4 months postoperatively and reported greater satisfaction and less pain at 4 and 12 months postoperatively.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bartels', 'Affiliation': 'Department of Orthopaedic Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Torbjørn B', 'Initials': 'TB', 'LastName': 'Kristensen', 'Affiliation': 'Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Gjertsen', 'Affiliation': 'Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Rogmark', 'Affiliation': 'Department of Orthopaedics, Skåne University Hospital, Lund University, Malmö, Sweden.'}, {'ForeName': 'Filip C', 'Initials': 'FC', 'LastName': 'Dolatowski', 'Affiliation': 'Department of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Wender', 'Initials': 'W', 'LastName': 'Figved', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jūratė Šaltytė', 'Initials': 'JŠ', 'LastName': 'Benth', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Stein Erik', 'Initials': 'SE', 'LastName': 'Utvåg', 'Affiliation': 'Department of Orthopaedic Surgery, Akershus University Hospital, Lørenskog, Norway.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.21.01411']
1885,35700052,"Women of Worth: the impact of a cash plus intervention to enhance attendance and reduce sexual health risks for young women in Cape Town, South Africa.","INTRODUCTION


Conditional cash transfers (CTs) augmented with other interventions are promising interventions for reducing HIV risk in adolescent girls and young women.
METHODS


A multi-phase, quasi-experimental study assessed the impact of a CT (ZAR300; $22) conditional on attending a skills building intervention, Women of Worth (WoW), designed to improve sexual and reproductive health (SRH) outcomes in Cape Town, South Africa from May 2017 to December 2019. The intervention entailed 12 sessions with encouragement to attend adolescent and youth-friendly health services. Women aged 19-24 years were randomized 1:1 to receive the intervention with a CT (""cash + care"" or C+C) or without a CT (""care""). The study included a pilot phase followed by a post-modification phase with improved uptake and retention without changing programme content or CT. Self-reported HIV prevalence and SRH/HIV vulnerability were assessed via a self-administered questionnaire at baseline, after 11 sessions, and 6-30 months' post-intervention for a subset. Mixed effect logistic regression models were fitted to estimate within-subject changes in outcomes.
RESULTS


Of 5116 participants, 904 (452 participants per arm) were in the pilot and 4212 (2039 ""care"" participants and 2173 ""C+C"" participants) were in the post modified phase. There were 1867 (85.9%) and 135 (6,6%) participants in the ""C+C"" group and the ""Care,"" respectively, that were WoW completers (≥ 11 sessions/retention). During the pilot phase, 194 (42.9%) and 18 (4.0%) participants in ""C+C"" and the ""care"" groups were retained. Receiving a CT sustained participation nearly 60-fold (OR 60.37; 95% CI: 17.32; 210.50, p <0.001). Three-hundred and thirty women were followed for a median of 15.0 months [IQR: 13.3; 17.8] to assess the durability of impact. Self-reported new employment status increased more than three-fold (p <0.001) at WoW completion and was sustained to the longer time point. Intimate partner violence indicators were reduced immediately after WoW, but this was not durable.
CONCLUSIONS


Participants receiving CT had sustained participation in an SRH/HIV prevention skills building with improvement in employment and some SRH outcomes. Layered, ""young woman centred"" programmes to address HIV and SRH risk in young women may be enhanced with CT.",2022,"Receiving a CT sustained participation nearly 60-fold (OR 60.37; 95% CI: 17.32; 210.50, p <0.001).","['adolescent girls and young women', 'Three-hundred and thirty women', 'young women in Cape Town, South Africa', 'Cape Town, South Africa from May 2017 to December 2019', 'Women aged 19-24 years', 'Of 5116 participants, 904 (452 participants per arm) were in the pilot and 4212 (2039 ""care"" participants and 2173 ""C+C"" participants']","['intervention entailed 12 sessions with encouragement to attend adolescent and youth-friendly health services', 'CT (""cash + care"" or C+C) or without a CT (""care', 'Conditional cash transfers (CTs', 'cash plus intervention']","['Self-reported HIV prevalence and SRH/HIV vulnerability', 'durability of impact', 'Self-reported new employment status', 'Intimate partner violence indicators', 'sexual health risks']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",330.0,0.095929,"Receiving a CT sustained participation nearly 60-fold (OR 60.37; 95% CI: 17.32; 210.50, p <0.001).","[{'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Naledi', 'Affiliation': 'Desmond Tutu HIV Centre, UCT Health Sciences Faculty, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Little', 'Affiliation': 'Department of Statistical Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Pike', 'Affiliation': 'Desmond Tutu HIV Centre, UCT Health Sciences Faculty, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Harley', 'Initials': 'H', 'LastName': 'Edwards', 'Affiliation': 'Desmond Tutu HIV Centre, UCT Health Sciences Faculty, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Robbertze', 'Affiliation': 'Desmond Tutu HIV Centre, UCT Health Sciences Faculty, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Wagner', 'Affiliation': 'Desmond Tutu HIV Centre, UCT Health Sciences Faculty, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'London', 'Affiliation': 'Division of Public Health Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, UCT Health Sciences Faculty, University of Cape Town, Cape Town, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25938']
1886,35700019,Promoting Physical Activity Among University Students During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Since the beginning of the COVID-19 pandemic, sanitary context and e-learning have greatly modified student lifestyles and led to deteriorations in their mental health. An increase in anxiety and depressive symptoms and sedentary behaviors, reduction in physical activity, and a stronger tendency to move toward unhealthy diet have been demonstrated. This finding highlights the need for innovative interventions to promote healthy lifestyle among students.
OBJECTIVE


This research protocol aims to evaluate the effects of an intervention program on the lifestyle and psychological state of students.
METHODS


Students from University of Nîmes were recruited and randomly assigned to 1 of 2 following conditions: an intervention group and a control group. Participants in the intervention group were engaged in an 8-week physical activity program. Prior to the start of the program, design-based innovative workshops were conducted with participants to ensure that the program was co-constructed by the users and met their specific needs. Students in the control group did not receive any intervention. For each group, measures of physical activity, sedentary time, anthropometric data, sleep, physical condition, and psychological variables (eg, anxiety, depression, motivation, body appreciation, perceived control, well-being) were conducted at baseline and 9 weeks later.
RESULTS


A total of 110 participants were initially included. Reporting of the results is projected for the spring of 2022.
CONCLUSIONS


It is anticipated that this innovative intervention co-constructed by pairs will promote a healthier lifestyle and psychological health in students. There is every reason to believe that a mobilized co-construction approach is a promising strategy to limit unhealthy habits and promote physical activity while increasing motivation. The development and evaluation of interventions to address the specific needs of university students is essential and could be transferred to other vulnerable populations such as people with chronic diseases or older people.
TRIAL REGISTRATION


ClinicalTrials.gov NCT05019482; https://clinicaltrials.gov/ct2/show/NCT05019482.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/36429.",2022,"An increase in anxiety and depressive symptoms and sedentary behaviors, reduction in physical activity, and a stronger tendency to move toward unhealthy diet have been demonstrated.","['University Students', 'A total of 110 participants were initially included', 'people with chronic diseases or older people', 'Students from University of Nîmes', 'students', 'healthy lifestyle among students', 'university students']","['intervention program', '8-week physical activity program']","['physical activity, sedentary time, anthropometric data, sleep, physical condition, and psychological variables (eg, anxiety, depression, motivation, body appreciation, perceived control, well-being', 'anxiety and depressive symptoms and sedentary behaviors, reduction in physical activity']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",110.0,0.0462966,"An increase in anxiety and depressive symptoms and sedentary behaviors, reduction in physical activity, and a stronger tendency to move toward unhealthy diet have been demonstrated.","[{'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Goncalves', 'Affiliation': 'APSY-V, Université de Nîmes, Nîmes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bernal', 'Affiliation': 'APSY-V, Université de Nîmes, Nîmes, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Korchi', 'Affiliation': 'APSY-V, Université de Nîmes, Nîmes, France.'}, {'ForeName': 'Maxence', 'Initials': 'M', 'LastName': 'Nogrette', 'Affiliation': 'APSY-V, Université de Nîmes, Nîmes, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Deshayes', 'Affiliation': 'APSY-V, Université de Nîmes, Nîmes, France.'}, {'ForeName': 'Antony G', 'Initials': 'AG', 'LastName': 'Philippe', 'Affiliation': 'APSY-V, Université de Nîmes, Nîmes, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Gisclard', 'Affiliation': 'Projekt, Université de Nîmes, Nîmes, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Charbonnier', 'Affiliation': 'APSY-V, Université de Nîmes, Nîmes, France.'}]",JMIR research protocols,['10.2196/36429']
1887,35700014,Immersive Virtual Reality Exergames to Promote the Well-being of Community-Dwelling Older Adults: Protocol for a Mixed Methods Pilot Study.,"BACKGROUND


Despite the proven benefits of exercise in older adults, challenges such as access and motivation can deter their engagement. Interactive virtual reality (VR) games combined with exercise (exergames) are a plausible strategy to encourage physical activity among this population. However, there has been little research on the feasibility, acceptability, and potential benefits of deploying at-home VR exergames among community-dwelling older adults.
OBJECTIVE


The objectives of this study are to estimate the feasibility, usability, and acceptability of a co-designed VR exergame in community-dwelling older adults; examine intervention feasibility and assessment protocols for a future large-scale trial; and provide pilot data on outcomes of interest (physical activity, exercise self-efficacy, mood, cognition, perception, and gameplay metrics).
METHODS


The study will be a remote, 6-week intervention comprising an experimental and a control group. A sample of at least 12 community-dwelling older adults (with no or mild cognitive impairment) will be recruited for each group. Both groups will follow the same study procedures and assessment methods. However, the experimental group will engage with a co-designed VR exergame (Seas The Day) thrice weekly for approximately 20 minutes using the Oculus Quest 2 (Facebook Reality Labs) VR headset. The control group will read (instead of playing Seas The Day) thrice weekly for approximately 20 minutes over the 6-week period. A mixed methods evaluation will be used. Changes in physical activity, exercise self-efficacy, mood, cognition, and perception will be compared before and after acute data as well as before and after the 6 weeks between the experimental (exergaming) and control (reading) groups. Qualitative data from postintervention focus groups or interviews and informal notes and reports from all participants will be analyzed to assess the feasibility of the study protocol. Qualitative data from the experimental group will also be analyzed to assess the feasibility, usability, and acceptability of at-home VR exergames and explore perceived facilitators of and barriers to uptaking VR systems among community-dwelling older adults.
RESULTS


The screening and recruitment process for the experimental group started in May 2021, and the data collection process will be completed by September 2021. The timeline of the recruitment process for the control group is September 2021 to December 2021. We anticipate an estimated adherence rate of ≥80%. Challenges associated with VR technology and the complexity of remote assessments are expected.
CONCLUSIONS


This pilot study will provide important information on the feasibility, acceptability, and usability of a custom-made VR exergaming intervention to promote older adults' well-being. Findings from this study will be useful to inform the methodology, design, study procedures, and assessment protocol for future large-scale trials of VR exergames with older adults as well as deepen the understanding of remote deployment and at-home use of VR for exercise in older adults.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/32955.",2022,"Changes in physical activity, exercise self-efficacy, mood, cognition, and perception will be compared before and after acute data as well as before and after the 6 weeks between the experimental (exergaming) and control (reading) groups.","['community-dwelling older adults', 'Community-Dwelling Older Adults', 'older adults', 'A sample of at least 12 community-dwelling older adults (with no or mild cognitive impairment']","['VR headset', 'control group will read (instead of playing Seas', 'Immersive Virtual Reality Exergames', 'co-designed VR exergame', 'custom-made VR exergaming intervention', 'Interactive virtual reality (VR) games combined with exercise (exergames']","['feasibility, usability, and acceptability', 'physical activity, exercise self-efficacy, mood, cognition, and perception', 'interest (physical activity, exercise self-efficacy, mood, cognition, perception, and gameplay metrics']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",,0.037855,"Changes in physical activity, exercise self-efficacy, mood, cognition, and perception will be compared before and after acute data as well as before and after the 6 weeks between the experimental (exergaming) and control (reading) groups.","[{'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Mehrabi', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Muñoz', 'Affiliation': 'Department of Systems Design Engineering, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Aysha', 'Initials': 'A', 'LastName': 'Basharat', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Boger', 'Affiliation': 'Department of Systems Design Engineering, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Systems Design Engineering, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Barnett-Cowan', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Middleton', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}]",JMIR research protocols,['10.2196/32955']
1888,35700005,A Case Management Program at Home to Reduce Fall Risk in Older Adults (the MAGIC Study): Protocol for a Single-Blind Randomized Controlled Trial.,"BACKGROUND


Individual case management programs may be particularly effective in reducing fall risk as they can better identify barriers and facilitators to health recommendations.
OBJECTIVE


This paper describes the protocol for a single-blind, parallel-group randomized controlled trial that aims to investigate the effectiveness and cost-effectiveness of a home-based multifactorial program targeting fall risk factors among people aged 60 years and over who have fallen at least twice in the past 12 months (the MAGIC trial).
METHODS


Older people with a history of at least 2 falls in the last year will be divided into 2 groups. The intervention group will receive case management at home for reducing the risk of falls, including a multidimensional assessment, explanation of fall risk factors, and elaboration and monitoring of an individualized intervention plan based on the identified fall risk factors, personal preferences, and available resources. The control group will be monitored once a month. Assessments (clinical data, fall risk awareness, physical and mental factors, safety at home, feet and shoes, and risk and rate of falls) will be carried out at baseline, after 16 weeks of the intervention, and at the posttrial 6-week and 1-year follow-up. After 16 weeks of the intervention, satisfaction and adherence to the intervention will also be assessed. Economic health will be evaluated for the period up to the posttrial 1-year follow-up.
RESULTS


Data collection started in April 2021, and we expected to end recruitment in December 2021. This case management program will address multifactorial assessments using validated tools and the implementation of individualized intervention plans focused on reducing fall risk factors.
CONCLUSIONS


This trial may provide reliable and valuable information about the effectiveness of case management for increasing fall risk awareness and reducing fall risk in older people.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry (ReBec) RBR-3t85fd; https://ensaiosclinicos.gov.br/rg/RBR-3t85fd.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/34796.",2022,"This trial may provide reliable and valuable information about the effectiveness of case management for increasing fall risk awareness and reducing fall risk in older people.
","['Older people with a history of at least 2 falls in the last year will be divided into 2 groups', 'Older Adults (the MAGIC Study', 'older people', 'people aged 60 years and over who have fallen at least twice in the past 12 months (the MAGIC trial']",['home-based multifactorial program'],"['Fall Risk', 'satisfaction and adherence', 'Assessments (clinical data, fall risk awareness, physical and mental factors, safety at home, feet and shoes, and risk and rate of falls', 'effectiveness and cost-effectiveness']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024460', 'cui_str': 'Magic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0365373,"This trial may provide reliable and valuable information about the effectiveness of case management for increasing fall risk awareness and reducing fall risk in older people.
","[{'ForeName': 'Silsam Napolitano', 'Initials': 'SN', 'LastName': 'Alberto', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Juliana Hotta', 'Initials': 'JH', 'LastName': 'Ansai', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Ana Luísa', 'Initials': 'AL', 'LastName': 'Janducci', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'João Vitor Businaro', 'Initials': 'JVB', 'LastName': 'Florido', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Areta Dames Cachapuz', 'Initials': 'ADC', 'LastName': 'Novaes', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Maria Joana Duarte', 'Initials': 'MJD', 'LastName': 'Caetano', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Paulo Giusti', 'Initials': 'PG', 'LastName': 'Rossi', 'Affiliation': 'Department of Physiotherapy, Federal University of São Carlos, São Carlos, SP, Brazil.'}, {'ForeName': 'Larissa Riani Costa', 'Initials': 'LRC', 'LastName': 'Tavares', 'Affiliation': 'Department of Physiotherapy, Federal University of São Carlos, São Carlos, SP, Brazil.'}, {'ForeName': 'Stephen Ronald', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Australia and School of Public Health & Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Gramani-Say', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}]",JMIR research protocols,['10.2196/34796']
1889,35700000,The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial.,"BACKGROUND


It is known that magnetic resonance imaging (MRI) procedures generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI procedure to be repeated with sedation. Few studies seem to have looked at the effect of immersive virtual reality (IVR) on anxiety in children scheduled for MRI scans and how to identify which children are more responsive.
OBJECTIVE


The aims of this study are 3-fold: develop an algorithm of predictability based on biofeedback, address feasibility and acceptability of preprocedural IVR game preparation for anxiety management during MRI procedures, and examine the efficacy of IVR game preparation compared with usual care for the management of procedural anxiety during MRI scans.
METHODS


This study will have 2 phases. We will first conduct a field test with 10 participants aged 7 to 17 years to develop a predictive algorithm for biofeedback solution and to address the feasibility and acceptability of the research. After the field test, a randomized controlled trial will be completed using a parallel design with 2 groups: an experimental group (preprocedural IVR game preparation) and a usual care group (standard care as per the radiology department's protocol) in an equal ratio of 49 participants per group for 98 participants. Recruitment will be carried out at a hospital in Quebec, Canada. The experimental group will receive a preprocedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI scan. Participants will complete a questionnaire to assess the acceptability, feasibility, and incidence of side effects related to the intervention and the biofeedback device. Data collected will include sociodemographic and clinical characteristics as well as measures of procedure-related anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (score 1-3) and the Children's Fear Scale (score 0-4). Physiological signs will be noted and include heart rate, skin conductance, hand temperature, and muscle tension. Measures of the level of satisfaction of health care professionals, parents, and participants will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a Cronbach α significance level of .05.
RESULTS


As of May 10, 2022, no participant was enrolled in the clinical trial. The data collection time frame is projected to be between April 1, 2022, and March 31, 2023. Findings will be disseminated through peer-reviewed publications.
CONCLUSIONS


Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI procedure. The biofeedback will help predict which children are more responsive to this type of intervention. This study will guide future medical practice by providing evidence-based knowledge on a nonpharmacological therapeutic modality for anxiety management in children scheduled for an MRI scan.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04988516; https://clinicaltrials.gov/ct2/show/NCT04988516.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/30616.",2022,"Participants will complete a questionnaire to assess the acceptability, feasibility, and incidence of side effects related to the intervention and the biofeedback device.","['10 participants aged 7 to 17 years', 'children scheduled for an MRI scan', 'Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE']","['Virtual Reality Game Preparation', 'IVR game preparation', 'immersive virtual reality (IVR', 'preprocedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI scan', 'preprocedural IVR game preparation', ""experimental group (preprocedural IVR game preparation) and a usual care group (standard care as per the radiology department's protocol"", 'magnetic resonance imaging (MRI']","['acceptability, feasibility, and incidence of side effects', 'heart rate, skin conductance, hand temperature, and muscle tension']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0587500', 'cui_str': 'Radiology department'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}]",10.0,0.201473,"Participants will complete a questionnaire to assess the acceptability, feasibility, and incidence of side effects related to the intervention and the biofeedback device.","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Le May', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Genest', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hung', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Francoeur', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Guingo', 'Affiliation': 'Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, QC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Paquette', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fortin', 'Affiliation': 'Research Center, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Guay', 'Affiliation': ""Trauma Studies Centre, Institut Universitaire en Santé Mentale de Montréal, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Est-de-l'Île de Montréal, Montreal, QC, Canada.""}]",JMIR research protocols,['10.2196/30616']
1890,35703041,Cost-effectiveness of a Paclitaxel-Eluting Stent (eluvia) compared to Zilver PTX for endovascular femoropopliteal intervention.,"OBJECTIVES


Antiproliferative therapies based on paclitaxel have been developed to extend the durability of endovascular interventions for lower-extremity atherosclerotic peripheral artery disease, resulting in improved primary vessel patency and fewer target lesion revascularizations. This study evaluated the cost-effectiveness of the sustained-release, paclitaxel-eluting Eluvia stent (Boston Scientific, Marlborough, MA) versus the paclitaxel-coated Zilver PTX stent (Cook Medical, Bloomington, IN) for endovascular intervention in the superficial femoral or proximal popliteal artery.
DESIGN


A microsimulation model was constructed from a United States Medicare perspective with a 24-month time horizon. Patients entering the model were assigned to initial endovascular intervention with either Eluvia or Zilver PTX. Each month patients were exposed to the risks of primary vessel patency loss, target lesion revascularization, amputation, and death. Clinical input parameters were taken from a randomized trial (IMPERIAL) comparing the two interventions at 24-months follow-up. Cost parameters were obtained from analyses of Medicare administrative and claims data. Cost-effectiveness analysis entailed sampling a complete set of clinical and cost parameters from their respective distributions, and then running cohorts of 10,000 patients through each intervention arm of the model. One-way and probabilistic sensitivity analyses were performed.
RESULTS


In the base case microsimulation, at 24 months, the modeled target lesion revascularization was 11.6% for Eluvia and 19.0% for Zilver PTX, and the mean total direct costs were $20,010 and $21,356, respectively (Eluvia average savings =$1,346). In probabilistic sensitivity analyses, Eluvia was cost-effective in 87.8% of all simulations at a willingness-to-pay threshold of $10,000 per target lesion revascularization prevented. Eluvia was more effective and less costly (dominant) than Zilver PTX in 73.6% of simulations.
CONCLUSIONS


In this comparison of a paclitaxel-eluting to a paclitaxel-coated stent for endovascular femoropopliteal intervention, Eluvia was more effective and less costly (dominant) than Zilver PTX from a US Medicare perspective. These findings should be considered when formulating reimbursement policy and clinical practice guidelines.",2022,"Eluvia was more effective and less costly (dominant) than Zilver PTX in 73.6% of simulations.
","['10,000 patients through each intervention arm of the model']","['paclitaxel-coated Zilver PTX stent (Cook Medical, Bloomington, IN) for endovascular intervention', 'initial endovascular intervention with either Eluvia or Zilver PTX', 'Paclitaxel-Eluting Stent (eluvia', 'paclitaxel-eluting Eluvia stent (Boston Scientific, Marlborough, MA', 'paclitaxel-eluting to a paclitaxel-coated stent']","['Cost-effectiveness', 'modeled target lesion revascularization', 'risks of primary vessel patency loss, target lesion revascularization, amputation, and death', 'cost-effectiveness', 'mean total direct costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0411282', 'cui_str': 'Endovascular radiological intervention'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0471235,"Eluvia was more effective and less costly (dominant) than Zilver PTX in 73.6% of simulations.
","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Division of Cardiovascular Diseases, Lankenau Heart Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Griffiths', 'Affiliation': 'Boston Scientific, Marlborough, MA, USA.'}, {'ForeName': 'Peter W M', 'Initials': 'PWM', 'LastName': 'Elroy', 'Affiliation': 'BresMed Health Solutions, Sheffield, UK.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Amorosi', 'Affiliation': 'Boston Scientific, Marlborough, MA, USA.'}, {'ForeName': 'Alysha M', 'Initials': 'AM', 'LastName': 'McGovern', 'Affiliation': 'Boston Scientific, Marlborough, MA, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Boston Scientific, Marlborough, MA, USA.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Akehurst', 'Affiliation': 'BresMed Health Solutions, Sheffield, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Müller-Hülsbeck', 'Affiliation': 'Diaconess Hospital Flensburg, Flensburg, DE.'}]",Journal of medical economics,['10.1080/13696998.2022.2088965']
1891,35702925,Changes in perceived parental self-efficacy after a Child-Centred Health Dialogue about preventing obesity.,"AIM


This randomised controlled trial evaluated changes in parental self-efficacy and children's weight, after a Child-Centred Health Dialogue about preventing obesity.
METHODS


We randomly assigned 37 Child Health Centres in Skåne county Sweden to provide usual care or the dialogue intervention. They included centres from high and low socioeconomic areas. The outcomes were changes in parental self-efficacy and any moderating effect on their children's body mass index 1 year later.
RESULTS


The baseline data were based on 1,115 mothers and 869 fathers representing 1197 children (52% females) aged 4 years (3.9-4.2) with a standardised body mass index (zBMI) of 0.1±0.9. The participation rates at follow up, 1.1±0.2 years after the intervention were 817 mothers and 508 fathers. Overall, parental self-efficacy had decreased by the 1-year follow up. There was a significant intervention effect on maternal self-efficacy in promoting physical activity, however with unclear clinical relevance. Mothers' change in perceived self-efficacy in promoting a healthy diet seemed to moderate the intervention effect on zBMI change in children with zBMI>0 with -0.01 (95% CI -0.025 to -0.001; p=0.03).
CONCLUSION


Our study suggested a possible link between increased maternal self-efficacy in promoting a healthy diet and a favourable development of zBMI.",2022,"Mothers' change in perceived self-efficacy in promoting a healthy diet seemed to moderate the intervention effect on zBMI change in children with zBMI>0 with -0.01 (95% CI -0.025 to -0.001; p=0.03).
","['817 mothers and 508 fathers', '1,115 mothers and 869 fathers representing 1197 children (52% females) aged 4\u2009years (3.9-4.2) with a standardised body mass index (zBMI) of 0.1±0.9']",['37 Child Health Centres in Skåne county Sweden to provide usual care or the dialogue intervention'],"['Overall, parental self-efficacy', 'self-efficacy', 'zBMI change', ""parental self-efficacy and any moderating effect on their children's body mass index 1 year later"", 'maternal self-efficacy', 'participation rates']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",1197.0,0.0287922,"Mothers' change in perceived self-efficacy in promoting a healthy diet seemed to moderate the intervention effect on zBMI change in children with zBMI>0 with -0.01 (95% CI -0.025 to -0.001; p=0.03).
","[{'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Derwig', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Sweden.'}, {'ForeName': 'Irén', 'Initials': 'I', 'LastName': 'Tiberg', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Björk', 'Affiliation': 'Department of Laboratory Medicine, Lund University, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Kristensson Hallström', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.16453']
1892,35702866,Modelling methicillin-resistant  Staphylococcus aureus  decolonization: interactions between body sites and the impact of site-specific clearance.,"Methicillin-resistant  Staphylococcus aureus  (MRSA) can colonize multiple body sites, and carriage is a risk factor for infection. Successful decolonization protocols reduce disease incidence; however, multiple protocols exist, comprising diverse therapies targeting multiple body sites, and the optimal protocol is unclear. Standard methods cannot infer the impact of site-specific components on successful decolonization. Here, we formulate a Bayesian coupled hidden Markov model, which estimates interactions between body sites, quantifies the contribution of each therapy to successful decolonization, and enables predictions of the efficacy of therapy combinations. We applied the model to longitudinal data from a randomized controlled trial (RCT) of an MRSA decolonization protocol consisting of chlorhexidine body and mouthwash and nasal mupirocin. Our findings (i) confirmed nares as a central hub for MRSA colonization and nasal mupirocin as the most crucial therapy and (ii) demonstrated all components contributed significantly to the efficacy of the protocol and the protocol reduced self-inoculation. Finally, we assessed the impact of hypothetical therapy improvements  in silico  and found that enhancing MRSA clearance at the skin would yield the largest gains. This study demonstrates the use of advanced modelling to go beyond what is typically achieved by RCTs, enabling evidence-based decision-making to streamline clinical protocols.",2022,"Here, we formulate a Bayesian coupled hidden Markov model, which estimates interactions between body sites, quantifies the contribution of each therapy to successful decolonization, and enables predictions of the efficacy of therapy combinations.",[],"['chlorhexidine body and mouthwash and nasal mupirocin', 'Methicillin-resistant  Staphylococcus aureus  (MRSA']",['MRSA clearance'],[],"[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0343401', 'cui_str': 'Methicillin resistant Staphylococcus aureus infection'}]","[{'cui': 'C0343401', 'cui_str': 'Methicillin resistant Staphylococcus aureus infection'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0327676,"Here, we formulate a Bayesian coupled hidden Markov model, which estimates interactions between body sites, quantifies the contribution of each therapy to successful decolonization, and enables predictions of the efficacy of therapy combinations.","[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Poyraz', 'Affiliation': 'Department of Computer Science, Aalto University School of Science, Aalto, Finland.'}, {'ForeName': 'Mohamad R A', 'Initials': 'MRA', 'LastName': 'Sater', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Loren G', 'Initials': 'LG', 'LastName': 'Miller', 'Affiliation': 'Division of Infectious Diseases, Lundquist Institute at Harbor-UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McKinnell', 'Affiliation': 'Division of Infectious Diseases, Lundquist Institute at Harbor-UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'Division of Infectious Diseases, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Yonatan H', 'Initials': 'YH', 'LastName': 'Grad', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Marttinen', 'Affiliation': 'Department of Computer Science, Aalto University School of Science, Aalto, Finland.'}]","Journal of the Royal Society, Interface",['10.1098/rsif.2021.0916']
1893,35703307,The Effect of Early-Life Seizures on Cognitive and Motor Development: A Case Series.,"PURPOSE


This case series documents developmental changes over time and in response to a novel intervention, Sitting Together and Reaching to Play (START-Play), in children with early-life seizures.
METHODS


Thirteen children with early-life seizures were included from a subset of participants in the START-Play multisite, randomized controlled trial. Seven received 3 months of twice weekly START-Play intervention; 6 continued with usual care early intervention. Bayley Scales of Infant Development-III (Cognitive Composite), Gross Motor Function Measure-66 Item Set, Assessment of Problem-Solving in Play, and reaching assessments were administered at baseline, 3, 6, and 12 months postbaseline. Change scores are reported at 3 and 12 months postbaseline.
RESULTS


Over time, plateau or decline was noted in standardized cognition measures; motor development improved or was stable. Children receiving START-Play showed positive trends in problem-solving (71.4%) and reaching behaviors (57.2%).
CONCLUSIONS


Interventions such as START-Play that combine motor and cognitive constructs may benefit children with early-life seizures.",2022,"Children receiving START-Play showed positive trends in problem-solving (71.4%) and reaching behaviors (57.2%).
","['children with early-life seizures', 'Thirteen children with early-life seizures']",['START-Play intervention; 6 continued with usual care early intervention'],"['Change scores', 'Cognitive and Motor Development', 'reaching behaviors', 'Gross Motor Function Measure-66 Item Set, Assessment of Problem-Solving in Play, and reaching assessments', 'Bayley Scales of Infant Development-III']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0439070', 'cui_str': 'III'}]",13.0,0.0861419,"Children receiving START-Play showed positive trends in problem-solving (71.4%) and reaching behaviors (57.2%).
","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jensen-Willett', 'Affiliation': 'Department of Physical Therapy (Dr Willett), Munroe-Meyer Institute, University of Nebraska Medical Center, Omaha, Nebraska; Department of Physical Therapy (Drs Cunha and Lobo), Biomechanics and Movement Science Program, University of Delaware, Newark, Delaware; Department of Physical Therapy (Dr Harbourne), Duquesne University, Pittsburgh, Pennsylvania; Division of Biokinesiology and Physical Therapy (Dr Dusing), University of Southern California, Los Angeles CA; Department of Rehabilitation Medicine (Drs Westcott-McCoy and Hsu), University of Washington, Seattle, Washington; Nebraska Center for Research on Children, Youth, Families and Schools (Drs Koziol and Bovaird), University of Nebraska-Lincoln, Lincoln, Nebraska; College of Human Science and Education (Dr Marcinowski), Louisiana State University, Baton Rouge, Louisiana; Department of Psychological Science (Dr Babik), Boise State University, Boise, Idaho; Department of Physical Therapy (Dr An), Kaya University, Gimhae-si, Gyeongsangnam-do, Republic of Korea.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cunha', 'Affiliation': ''}, {'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Lobo', 'Affiliation': ''}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Harbourne', 'Affiliation': ''}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Dusing', 'Affiliation': ''}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'McCoy', 'Affiliation': ''}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Koziol', 'Affiliation': ''}, {'ForeName': 'Lin-Ya', 'Initials': 'LY', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Marcinowski', 'Affiliation': ''}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Babik', 'Affiliation': ''}, {'ForeName': 'Mihee', 'Initials': 'M', 'LastName': 'An', 'Affiliation': ''}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Bovaird', 'Affiliation': ''}]",Pediatric physical therapy : the official publication of the Section on Pediatrics of the American Physical Therapy Association,['10.1097/PEP.0000000000000918']
1894,35703293,Lifestyle modification and cognitive function among individuals with resistant hypertension: cognitive outcomes from the TRIUMPH trial.,"BACKGROUND


Resistant hypertension is associated with increased risk of cognitive decline, stroke, and dementia. Lifestyle modification has been suggested to improve cognitive function through its salutary effects on vascular function.
METHODS


Participants included 140 patients with resistant hypertension participating in the TRIUMPH trial. Participants were randomized to a cardiac rehabilitation-based lifestyle program (C-LIFE) or a standardized education and physician advice condition (SEPA). Participants completed a 45-min cognitive test battery consisting of tests of Executive Functioning and Learning, Memory, and Processing Speed. Biomarkers of vascular [flow mediated dilation of the brachial artery (FMD)], microvascular, and cerebrovascular function were also collected, in addition to weight, fitness, and ambulatory blood pressure.
RESULTS


Participants averaged 63 years of age, 48% women, 59% black, and obese [mean BMI = 36 kg/m2 (SD = 4)]. Cognitive performance improved across the entire cohort during the 4-month trial [t-scores pretreatment = 48.9 (48, 50) vs. posttreatment = 50.0 (49, 51), P < 0.001]. Postintervention Executive Function/Learning composite performance was higher for participants in C-LIFE compared to SEPA (d = 0.37, P = 0.039). C-LIFE intervention effects on Memory and Processing Speed were moderated by sex and baseline stroke risk, respectively (P = 0.026 and P = 0.043 for interactions), such that males and participants with greater stroke risk showed the greatest cognitive changes. FMD [C-LIFE: +0.3% (-0.3, 1.0) vs. SEPA: -1.4% (-2.5, -0.3), P = 0.022], and microvascular function [C-LIFE: 97 (65, 130) vs. SEPA: 025 (-75, 23), P < 0.001] were improved in C-LIFE compared with SEPA, whereas cerebrovascular reactivity was not [C-LIFE: -0.2 (-0.4, 0) vs. SEPA: 0.1 (-0.2, 0.4), P = 0.197). Mediation analyses suggested that increased executive function/learning was associated with reduced ambulatory SBP levels secondary to weight loss [indirect effect: B = 0.25 (0.03, 0.71)].
CONCLUSION


Lifestyle modification individuals with resistant hypertension improves cognition, which appeared to be associated with reduced ambulatory SBP changes through weight loss. Cognitive improvements were accompanied by parallel improvements in endothelial and microvascular function.",2022,"Postintervention Executive Function/Learning composite performance was higher for participants in C-LIFE compared to SEPA (d = 0.37, P = 0.039).","['Participants included 140 patients with resistant hypertension participating in the TRIUMPH trial', 'individuals with resistant hypertension', 'Participants averaged 63\u200ayears of age, 48% women, 59% black, and obese [mean BMI\u200a=\u200a36\u200akg/m2 (SD\u200a=\u200a4']","['cardiac rehabilitation-based lifestyle program (C-LIFE) or a standardized education and physician advice condition (SEPA', '45-min cognitive test battery consisting of tests of Executive Functioning and Learning, Memory, and Processing Speed']","['Cognitive performance', 'weight, fitness, and ambulatory blood pressure', 'Memory and Processing Speed', 'executive function/learning', 'C-LIFE', 'Postintervention Executive Function/Learning composite performance', 'endothelial and microvascular function', 'microvascular function', 'cerebrovascular reactivity', 'Biomarkers of vascular [flow mediated dilation of the brachial artery (FMD)], microvascular, and cerebrovascular function']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C3643615', 'cui_str': 'Triumph'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}]",140.0,0.108074,"Postintervention Executive Function/Learning composite performance was higher for participants in C-LIFE compared to SEPA (d = 0.37, P = 0.039).","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham.'}, {'ForeName': 'Sherwood', 'Initials': 'S', 'LastName': 'Andrew', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Hinderliter', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mabe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham.'}, {'ForeName': 'Lana L', 'Initials': 'LL', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Craighead', 'Affiliation': 'Department of Psychology, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Ingle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Tyson', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham.'}, {'ForeName': 'Forgive', 'Initials': 'F', 'LastName': 'Avorgbedor', 'Affiliation': 'University of North Carolina at Greensboro, North Carolina, USA.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham.'}]",Journal of hypertension,['10.1097/HJH.0000000000003151']
1895,35703289,The Effects of Inhalational Lavender Essential Oil Aromatherapy on Sleep Quality in Hemodialysis Patients: A Before-and-After-Intervention Trial.,"One of the most essential physical prerequisites for human survival is sleep. Patients undergoing hemodialysis often experience a lack of sleep, and it is one of the decisive variables in dialysis patients' quality of life. The objective of this study was to assess the effects of inhaling lavender essential oil on sleep quality in hemodialysis patients. A total of 30 patients were enrolled in the before-and-after intervention trial, which took place in a tertiary care hospital's dialysis unit. The study participants were selected using the purposive sampling technique and they received lavender oil inhalation therapy. The sleep quality was measured using the Pittsburgh Sleep Quality Index. The mean age of the participants was 55.11 (SD = 8.45) years. The mean posttherapy Pittsburgh Global Sleep Quality Index score was 8.8 ± 1.89 compared with the pretherapy score of 14.73 ± 1.53. Patients undergoing hemodialysis experienced a substantial improvement in sleep quality (P < .05). Aromatherapy using lavender oil is effective in enhancing sleep quality in hemodialysis patients.",2022,Patients undergoing hemodialysis experienced a substantial improvement in sleep quality (P < .05).,"['Hemodialysis Patients', 'The mean age of the participants was 55.11 (SD = 8.45) years', ""30 patients were enrolled in the before-and-after intervention trial, which took place in a tertiary care hospital's dialysis unit"", 'hemodialysis patients', 'Patients undergoing hemodialysis often experience a lack of sleep']","['lavender oil inhalation therapy', 'Aromatherapy using lavender oil', 'Inhalational Lavender Essential Oil Aromatherapy', 'lavender essential oil']","['Pittsburgh Sleep Quality Index', 'sleep quality', 'mean posttherapy Pittsburgh Global Sleep Quality Index score', 'Sleep Quality']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0458754,Patients undergoing hemodialysis experienced a substantial improvement in sleep quality (P < .05).,"[{'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Beerappa', 'Affiliation': 'Cauvery College of Nursing, Cauvery Group of Institutions, Mysore, Karnataka, India (Mr Beerappa and Ms Kavana); and Department of Medical Surgical Nursing, Sri Ramachandra Faculty of Nursing, Sri Ramachandra Institute of Higher Education and Research, Chennai, India (Dr Ramesh).'}, {'ForeName': 'Kavana', 'Initials': 'K', 'LastName': 'Gt', 'Affiliation': ''}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Chandrababu', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000521']
1896,35703173,Lessons from effect of etelcalcetide on left ventricular hypertrophy in patients with end-stage kidney disease.,"PURPOSE OF REVIEW


Patients with end-stage kidney disease (ESKD) frequently develop left ventricular hypertrophy (LVH), which is associated with an exceptionally high risk of cardiovascular events and mortality. This review focuses on interventional studies that modify levels of fibroblast growth factor 23 (FGF23) and examine effects on myocardial hypertrophy, cardiovascular events and mortality.
RECENT FINDINGS


Quantitative evaluations of trials of calcimimetics found no effects on cardiovascular events and cardiovascular and all-cause mortality when compared with placebo. However, a recent randomized, controlled trial of etelcalcetide versus alfacalcidol showed that etelcalcetide effectively inhibited the progression of LVH in comparison to vitamin D in patients on haemodialysis after 1 year of treatment. Prior to that, oral calcimimetic treatment has already been shown to reduce left ventricular mass in patients on haemodialysis, whereas treatment with active vitamin D or mineralocorticoids was ineffective in patients with ESKD.
SUMMARY


Data from a recent trial of etelcalcetide on LVH suggest that FGF23 may be a possible therapeutic target for cardiac risk reduction in patients on haemodialysis. If these findings are confirmed by further research, it might be speculated that a treatment shift from active vitamin D towards FGF23-lowering therapy may occur in patients on haemodialysis.",2022,"Prior to that, oral calcimimetic treatment has already been shown to reduce left ventricular mass in patients on haemodialysis, whereas treatment with active vitamin D or mineralocorticoids was ineffective in patients with ESKD.
","['patients on haemodialysis', 'Patients with end-stage kidney disease (ESKD) frequently develop left ventricular hypertrophy (LVH', 'patients with ESKD', 'patients with end-stage kidney disease']","['etelcalcetide', 'placebo', 'etelcalcetide versus alfacalcidol']","['cardiovascular events and cardiovascular and all-cause mortality', 'myocardial hypertrophy, cardiovascular events and mortality', 'left ventricular hypertrophy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}]","[{'cui': 'C3713906', 'cui_str': 'etelcalcetide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3495916', 'cui_str': 'Myocardial hypertrophy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}]",,0.0680655,"Prior to that, oral calcimimetic treatment has already been shown to reduce left ventricular mass in patients on haemodialysis, whereas treatment with active vitamin D or mineralocorticoids was ineffective in patients with ESKD.
","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Dörr', 'Affiliation': 'Department of Nephrology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kainz', 'Affiliation': ''}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Oberbauer', 'Affiliation': ''}]",Current opinion in nephrology and hypertension,['10.1097/MNH.0000000000000799']
1897,35703145,Medihoney Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: An Open-Label Randomized Pilot Study.,,2022,,['Mild to Moderate Atopic Dermatitis in Children'],['Medihoney Derma Cream'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}]",[],,0.0147503,,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Horev', 'Affiliation': ''}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Sher', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weissmann', 'Affiliation': ''}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Golan', 'Affiliation': ''}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Horev', 'Affiliation': ''}]","Dermatitis : contact, atopic, occupational, drug",['10.1097/DER.0000000000000913']
1898,35703113,A phase II clinical trial of neoadjuvant sasanlimab and stereotactic body radiation therapy as an  in situ  vaccine for cisplatin-ineligible MIBC: the RAD VACCINE MIBC trial.,"The utilization of neoadjuvant immune checkpoint inhibitor therapy, specifically anti-PD-1/L1 agents, prior to radical cystectomy is an emerging paradigm in muscle-invasive bladder cancer (MIBC).  In situ  vaccination represents a strategy to manipulate the tumor in order to augment the immune response toward improved local and distant cancer control. The authors describe the study rationale, design and objectives for RAD VACCINE MIBC, a single-arm, single-institution, phase II trial evaluating the efficacy and safety of combination neoadjuvant sasanlimab (humanized IgG monoclonal antibody that targets PD-1) with stereotactic body radiotherapy as an  in situ  vaccine in cisplatin-ineligible patients with MIBC. The results from this trial will establish the safety profile of this combination strategy and evaluate pathologic complete response rates.",2022,In situ  vaccination represents a strategy to manipulate the tumor in order to augment the immune response toward improved local and distant cancer control.,"['ineligible patients with MIBC', 'muscle-invasive bladder cancer (MIBC']","['stereotactic body radiotherapy', 'cisplatin', 'neoadjuvant sasanlimab and stereotactic body radiation therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0604084,In situ  vaccination represents a strategy to manipulate the tumor in order to augment the immune response toward improved local and distant cancer control.,"[{'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Satkunasivam', 'Affiliation': 'Center for Outcomes Research, Houston Methodist Hospital, Houston, TX\xa077030, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'Department of Urology, Houston Methodist Hospital, Houston, TX\xa077030, USA.'}, {'ForeName': 'Bin S', 'Initials': 'BS', 'LastName': 'Teh', 'Affiliation': 'Department of Radiation Oncology, Houston Methodist Hospital, Houston, TX\xa077030, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Guzman', 'Affiliation': 'Department of Urology, Houston Methodist Hospital, Houston, TX\xa077030, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Houston Methodist Cancer Center, Houston, TX\xa077030, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Farach', 'Affiliation': 'Department of Radiation Oncology, Houston Methodist Hospital, Houston, TX\xa077030, USA.'}, {'ForeName': 'Shu-Hsia', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Center for Immunotherapy Research, Houston Methodist Research Institute, Houston, TX\xa077030, USA.'}, {'ForeName': 'Christopher Jd', 'Initials': 'CJ', 'LastName': 'Wallis', 'Affiliation': 'Division of Urology, University of Toronto, Toronto, ON M5G 1E2, Canada.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Medical Oncology, Houston Methodist Cancer Center, Houston, TX\xa077030, USA.'}, {'ForeName': 'Nestor F', 'Initials': 'NF', 'LastName': 'Esnaola', 'Affiliation': 'Department of Surgical Oncology, Houston Methodist Hospital, Houston, TX\xa077030, USA.'}, {'ForeName': 'Guru P', 'Initials': 'GP', 'LastName': 'Sonpavde', 'Affiliation': 'Department of Genitourinary Medical Oncology, Dana-Farber Cancer Institute, Boston, MA\xa002215, USA.'}]","Future oncology (London, England)",['10.2217/fon-2022-0380']
1899,35703097,Patient-Centered Outcomes in a Randomized Trial Investigating a Multimodal Prevention Program After Transient Ischemic Attack or Minor Stroke: The INSPiRE-TMS Trial.,"BACKGROUND


The INSPiRE-TMS trial (Intensified Secondary Prevention Intending a Reduction of Recurrent Events in Transient Ischemic Attack and Minor Stroke Patients) investigated effects of a multicomponent support program in patients with nondisabling stroke or transient ischemic attack. Although secondary prevention targets were achieved more frequently in the intensified care group, no significant differences were seen in rates of recurrent major vascular events. Here, we present the effects on prespecified patient-centered outcomes.
METHODS


In a multicenter trial, we randomized patients with modifiable risk factors either to the intensified or conventional care alone program. Intensified care was provided by stroke specialists and used feedback and motivational interviewing strategies (≥8 outpatient visits over 2 years) aiming to improve adherence to secondary prevention targets. We measured physical fitness, disability, cognitive function and health-related quality of life by stair-climbing test, modified Rankin Scale, Montreal Cognitive Assessment, and European Quality of Life 5 Dimension 3 Level during the first 3 years of follow-up.
RESULTS


Of 2072 patients (mean age: 67.4years, 34% female) assessed for the primary outcome, patient-centered outcomes were collected in 1,771 patients (877 intensified versus 894 conventional care group). Physical fitness improved more in the intensified care group (mean between-group difference in power (Watt): 24.5 after 1 year (95% CI, 5.5-43.5); 36.1 after 2 years (95% CI, 13.1-59.7) and 29.6 (95% CI, 2.0-57.3 after 3 years). At 1 year, there was a significant shift in ordinal regression analysis of modified Rankin Scale in favor of the intensified care group (common odds ratio, 1.23 [95% CI, 1.03-1.47]) but not after 2 (odds ratio, 1.17 [95% CI, 0.96-1.41]) or 3 years (odds ratio, 1.16 [95% CI, 0.95-1.43]) of follow-up. However, Montreal Cognitive Assessment and European Quality of Life 5 Dimension scores showed no improvement in the intensified intervention arm after 1, 2, or 3 years of follow-up.
CONCLUSIONS


Patients of the intensified care program group had slightly better results for physical fitness and modified Rankin Scale after 1 year, but none of the other patient-centered outcomes was significantly improved.
REGISTRATION


URL: https://www.
CLINICALTRIALS


gov; Unique identifier: NCT01586702.",2022,"However, Montreal Cognitive Assessment and European Quality of Life 5 Dimension scores showed no improvement in the intensified intervention arm after 1, 2, or 3 years of follow-up.
","['patients with modifiable risk factors either to the intensified or conventional care alone program', 'patients with nondisabling stroke or transient ischemic attack', '2072 patients (mean age: 67.4years, 34% female']","['Multimodal Prevention Program', 'multicomponent support program']","['Montreal Cognitive Assessment and European Quality of Life 5 Dimension scores', 'ordinal regression analysis of modified Rankin Scale', 'Physical fitness', 'physical fitness, disability, cognitive function and health-related quality of life by stair-climbing test, modified Rankin Scale, Montreal Cognitive Assessment, and European Quality of Life 5 Dimension 3 Level', 'physical fitness and modified Rankin Scale', 'rates of recurrent major vascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0034980', 'cui_str': 'Analysis, Regression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0430519', 'cui_str': 'Stair-climbing test'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",2072.0,0.0747041,"However, Montreal Cognitive Assessment and European Quality of Life 5 Dimension scores showed no improvement in the intensified intervention arm after 1, 2, or 3 years of follow-up.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ihl', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Laumeier', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Steinicke', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ferse', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Klyscz', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}, {'ForeName': 'Sidsel', 'Initials': 'S', 'LastName': 'Hastrup', 'Affiliation': 'The Danish Stroke Center, Department of Neurology, Aarhus University Hospital, Denmark (S.H., P.v.W.-M.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Poppert', 'Affiliation': 'Klinikum Rechts der Isar, Technical University Munich, Germany (H.P.).'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Palm', 'Affiliation': 'Klinikum Ludwigshafen, Germany (F.P.).'}, {'ForeName': 'Farid I', 'Initials': 'FI', 'LastName': 'Kandil', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Weber', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'von Weitzel-Mudersbach', 'Affiliation': 'The Danish Stroke Center, Department of Neurology, Aarhus University Hospital, Denmark (S.H., P.v.W.-M.).'}, {'ForeName': 'Martin L J', 'Initials': 'MLJ', 'LastName': 'Wimmer', 'Affiliation': 'Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, Munich, Germany (M.L.J.W.).'}, {'ForeName': 'Heinrich J', 'Initials': 'HJ', 'LastName': 'Audebert', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin (T.I., M.A., I.L., M.S., C.F., P.K., M.E., F.I.K., J.E.W., H.J.A.).'}]",Stroke,['10.1161/STROKEAHA.120.037503']
1900,35703454,"Editorial on Toesca A, et al ""A Randomized Trial of Robotic Mastectomy versus Open Surgery in Women With Breast Cancer or BRCA Mutation"".",,2022,,['Women With Breast Cancer or BRCA Mutation'],['Robotic Mastectomy versus Open Surgery'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]",[],,0.126911,,"[{'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': 'Hunt', 'Affiliation': 'Olla Stribling Distinguished Chair for Cancer Research, Chair, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1434, Houston, TX 77030-4008.'}]",Annals of surgery,['10.1097/SLA.0000000000005485']
1901,35703413,Impact of Artificial Intelligence Assistance on Chest CT Interpretation Times: A Prospective Randomized Study.,"Background:  Deep learning-based convolutional neural networks have enabled major advances in development of artificial intelligence (AI) software applications. Modern AI applications offer comprehensive multiorgan evaluation.  Objective:  To evaluate the impact of an automated AI platform, integrated into clinical workflow for chest CT interpretation, on radiologists' interpretation times when evaluated in a real-world clinical setting.  Methods:  In this prospective single-center study, a commercial AI software solution was integrated into clinical workflow for chest CT interpretation. The software provided automated analysis of cardiac, pulmonary, and musculoskeletal findings, including labeling, segmenting, and measuring normal structures as well as detecting, labeling, and measuring abnormalities. AI-annotated images and autogenerated summary results were stored in the PACS and available to interpreting radiologists. A total of 390 patients (204 female, 186 male; mean age, 62.8±13.3 years) who underwent outpatient chest CT between January 19, 2021 and January 28, 2021 were included. Scans were randomized using 1:1 allocation between AI-assisted and non-AI arms and were clinically interpreted by one of three cardiothoracic radiologists (65 scans per arm per radiologist; total of 190 scans per arm), who recorded interpretation times using a stopwatch. Findings were categorized based on review of report impressions. Interpretation times were compared between arms.  Results:  Mean interpretation times were significantly shorter in the AI-assisted than in the non-AI arm for all three readers (289±89 vs 344±129 seconds, p<.001; 449±110 vs 649±82 seconds, p<.001; 281±114 vs 348±93 seconds, p=.01) and for readers combined (328±122 vs 421±175 seconds, p<.001). For readers combined, the mean difference was 93 seconds (95% CI, 63-123 seconds), corresponding with a 22.1% reduction in the AI-assisted arm. Mean interpretation time was also shorter in the AI-assisted arm compared with the non-AI arm for contrast-enhanced scans (83 seconds), non-contrast scans (104 seconds), negative scans (84 seconds), positive scans without significant new findings (117 seconds), and positive scans with significant new findings (92 seconds).  Conclusion:  Cardiothoracic radiologists exhibited a 22.1% reduction in chest CT interpretations times when having access to results from an automated AI support platform during real-world clinical practice.  Clinical Impact:  Integration of the AI support platform into clinical workflow improved radiologist efficiency.",2022,"Mean interpretation time was also shorter in the AI-assisted arm compared with the non-AI arm for contrast-enhanced scans (83 seconds), non-contrast scans (104 seconds), negative scans (84 seconds), positive scans without significant new findings (117 seconds), and positive scans with significant new findings (92 seconds).  ","['390 patients (204 female, 186 male; mean age, 62.8±13.3 years) who underwent outpatient chest CT between January 19, 2021 and January 28, 2021 were included', 'Chest CT Interpretation Times']","['Deep learning-based convolutional neural networks', 'Artificial Intelligence Assistance']","['Mean interpretation times', 'Mean interpretation time', 'radiologist efficiency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",390.0,0.0495769,"Mean interpretation time was also shorter in the AI-assisted arm compared with the non-AI arm for contrast-enhanced scans (83 seconds), non-contrast scans (104 seconds), negative scans (84 seconds), positive scans without significant new findings (117 seconds), and positive scans with significant new findings (92 seconds).  ","[{'ForeName': 'Basel', 'Initials': 'B', 'LastName': 'Yacoub', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Varga-Szemes', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'U Joseph', 'Initials': 'UJ', 'LastName': 'Schoepf', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Ismail M', 'Initials': 'IM', 'LastName': 'Kabakus', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Dhiraj', 'Initials': 'D', 'LastName': 'Baruah', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Burt', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Gilberto J', 'Initials': 'GJ', 'LastName': 'Aquino', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'Sullivan', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': ""O' Doherty"", 'Affiliation': 'Siemens Medical Solutions USA, Malvern, PA, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hoelzer', 'Affiliation': 'Siemens Healthineers, Princeton, NJ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sperl', 'Affiliation': 'Siemens Healthineers, Erlangen, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Emrich', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}]",AJR. American journal of roentgenology,['10.2214/AJR.22.27598']
1902,35703373,"Efficacy, safety, tolerability and satisfaction of N-acetylcysteine and pentoxifylline in lichen planopilaris patients under treatment with topical clobetasol: a triple arm blinded randomized controlled trial.","BACKGROUND


Lichen planoplaris (LPP) is one of the most common causes of inflammatorycicatricial alopecias. There is no definitivecure for the disease and most of the available therapeutic optionscan potentially lead to serious complications following their use for extended durations. In this study, we aimed to evaluate the efficacy, safety and tolerability of N-acetylcysteine(NAC) and Pentoxyfillin (PTX),as adjunctive therapies, in the management of LPP.
METHODS


In a randomized, assessor- and analyst-blinded controlled trial, patients with proven LPP were randomly assignedto three groups of 10. Group I (the control group) received clobetasol 0.05%lotion; GroupII, a combination of clobetasol 0.05% lotion and oral PTX; Group III, a combination of clobetasol lotion 0.05% and oral NAC.Lichen planopilaris Activity Index (LPPAI), thepossible side effects, tolerability and patientssatisfaction were assessed before andtwo and fourmonths after the initiation of the treatments.
RESULTS


Thirty patients, 96.7% women, with a mean age of 46.8±13.3 years old, were included in the study. Four months into the treatments, the overall LPPAI and the severity and/or frequency of most of itsdeterminants significantly decreased in all groups. In a comparison among the groups, patients who received either of the combination therapies showed more decline in their LPPAI than those receiving only clobetasol.The decline was more noticeableand statistically significant only inthe NAC group. Three patients in the PTX group developed complications that were not statistically significant when compared with the other groups.There were no substantial differences in the tolerability of the treatments among thestudy arms.
CONCLUSION


The use of oral NAC and PTX added to the therapeutic efficacy of topical clobetasol in the treatment of LPP, suggesting that they might be beneficial and safe adjuvant therapies and add to the efficacy of topical treatmentwithout any noticeable impact on the adverse effects experienced by patients. This article is protected by copyright. All rights reserved.",2022,Three patients in the PTX group developed complications that were not statistically significant when compared with the other groups.,"['lichen planopilaris patients under treatment with topical clobetasol', 'patients with proven LPP', 'Thirty patients, 96.7% women, with a mean age of 46.8±13.3\u2009years old, were included in the study']","['PTX', 'N-acetylcysteine(NAC) and Pentoxyfillin', 'clobetasol 0.05%lotion; GroupII, a combination of clobetasol 0.05% lotion and oral PTX', 'clobetasol lotion 0.05% and oral NAC.Lichen planopilaris Activity Index (LPPAI', 'oral NAC and PTX', 'N-acetylcysteine and pentoxifylline']","['tolerability and patientssatisfaction', 'complications', 'decline in their LPPAI', 'Efficacy, safety, tolerability and satisfaction', 'tolerability', 'efficacy, safety and tolerability', 'overall LPPAI and the severity']","[{'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0023643', 'cui_str': 'Lichen'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",30.0,0.0747055,Three patients in the PTX group developed complications that were not statistically significant when compared with the other groups.,"[{'ForeName': 'Hossein Ahmadi', 'Initials': 'HA', 'LastName': 'Kahjoogh', 'Affiliation': 'Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nafise', 'Initials': 'N', 'LastName': 'Yazdanian', 'Affiliation': 'Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Behrangi', 'Affiliation': 'Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Roohaninasab', 'Affiliation': 'Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Hejazi', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Goodarzi', 'Affiliation': 'Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]",Dermatologic therapy,['10.1111/dth.15639']
1903,35703608,Attitudes of health professionals towards suicidal behavior: an intervention study.,"OBJECTIVE


To evaluate the effect of an educational intervention on the attitudes of primary healthcare providers regarding patients with suicidal behavior.
METHODS


Clinical trial randomized by clusters, with a sample of 261 healthcare professionals, from 22 health units selected by stratified sampling, were chosen and randomly allocated, by drawing, into two groups: intervention (n = 87) and control (n = 174). The participants of the intervention group were exposed to a 20-hour training on suicidal behavior. All 261 participants were evaluated before and after the intervention; the groups were compared to evaluate their attitude towards suicidal behavior using the Suicide Behavior Attitude Questionnaire (SBAQ), an evaluation made by comparison of the means via t-Student test, for independent samples, and paired t-test, for dependent samples.
RESULTS


The intervention group, in comparison to their evaluation before and after training, as well as in the comparison with the evaluation of the control group, showed statistically significant differences in attitudes towards suicidal behavior, according to the differences presented in the scores for the domains: ""perception of professional capacity,"" in all four items; ""negative feeling,"" in six of the seven items; and in the ""right to commit suicide"" domain, in three of the five items.
CONCLUSION


The brief training developed in primary health care was effective to improve the attitudes of the participants who were part of the intervention group regarding patients with suicidal behavior.",2022,The brief training developed in primary health care was effective to improve the attitudes of the participants who were part of the intervention group regarding patients with suicidal behavior.,"['Clinical trial randomized by clusters, with a sample of 261 healthcare professionals, from 22 health units selected by stratified sampling', 'participants who were part of the intervention group regarding patients with suicidal behavior', 'primary healthcare providers regarding patients with suicidal behavior']","['educational intervention', '20-hour training']","['perception of professional capacity,"" in all four items; ""negative feeling,"" in six of the seven items; and in the ""right to commit suicide"" domain', 'attitude towards suicidal behavior using the Suicide Behavior Attitude Questionnaire (SBAQ', 'attitudes towards suicidal behavior', 'suicidal behavior']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",261.0,0.00385213,The brief training developed in primary health care was effective to improve the attitudes of the participants who were part of the intervention group regarding patients with suicidal behavior.,"[{'ForeName': 'Jesiele Spindler', 'Initials': 'JS', 'LastName': 'Faria', 'Affiliation': 'Universidade Federal de Mato Grosso. Faculdade de Enfermagem. Cuiabá, MT, Brasil.'}, {'ForeName': 'Samira Reschetti', 'Initials': 'SR', 'LastName': 'Marcon', 'Affiliation': 'Universidade Federal de Mato Grosso. Faculdade de Enfermagem. Cuiabá, MT, Brasil.'}, {'ForeName': 'Alice Milani', 'Initials': 'AM', 'LastName': 'Nespollo', 'Affiliation': 'Universidade Federal de Mato Grosso. Faculdade de Enfermagem - Campus Sinop. Sinop, MT, Brasil.'}, {'ForeName': 'Hugo Gedeon Barros Dos', 'Initials': 'HGBD', 'LastName': 'Santos', 'Affiliation': 'Hospital Universitário Júlio Muller. Unidade de Atenção Psicossocial. Cuiabá, MT, Brasil.'}, {'ForeName': 'Mariano Martínez', 'Initials': 'MM', 'LastName': 'Espinosa', 'Affiliation': 'Universidade Federal de Mato Grosso. Instituto de Ciências Exatas e da Terra. Departamento de Estatística. Cuiabá, Mato Grosso, Brasil.'}, {'ForeName': 'Kleici Kleslly Brito de', 'Initials': 'KKB', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal de Mato Grosso. Faculdade de Enfermagem. Cuiabá, MT, Brasil.'}, {'ForeName': 'Josemara Gomes da Silva', 'Initials': 'JGDS', 'LastName': 'Lima', 'Affiliation': 'Universidade Federal de Mato Grosso. Programa de Pós-Graduação em Saúde Coletiva. Cuiabá, MT, Brasil.'}]",Revista de saude publica,['10.11606/s1518-8787.2022056003320']
1904,35704085,DHA status influences effects of B-vitamin supplementation on cognitive ageing: a post-hoc analysis of the B-proof trial.,"PURPOSE


Trials aiming to lower homocysteine by B-vitamin supplementation have reported mixed results on slowing cognitive decline. We investigated if efficacy of B-vitamin supplementation is affected by baseline plasma omega-3 fatty acid levels.
METHODS


This post-hoc analysis of the B-proof trial included 191 adults aged 65 years or older with baseline plasma total homocysteine ≥ 12 μmol/L, randomly assigned to 400 µg folic acid and 500 µg vitamin B12 or placebo daily for 2 years. Global and domain-specific cognitive functioning were assessed at baseline and after 2 years. The effect of B-vitamin supplementation was analyzed according to tertiles of baseline plasma omega-3 fatty acids concentrations combined, and eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) individually using multiple linear regression analyses.
RESULTS


The mean ± SD age of the participants was 71.6 ± 5.9 years and median [IQR] Mini-Mental State Examination was 29 [28-30]. The treatment effect of B-vitamins on global cognition was larger in participants in the high compared to the middle DHA tertile (difference in z-score, mean ± SE 0.22 ± 0.10, p = 0.03). There was no significant interaction between B-vitamin supplementation and combined omega-3 fatty acid (p = 0.49) and EPA (p = 0.99) tertiles. Similarly, the efficacy of B-vitamin treatment on domain-specific cognitive functioning did not link to omega-3 fatty acid, DHA, or EPA plasma levels.
CONCLUSION


This post-hoc analysis indicated that efficacy of B-vitamin supplementation in slowing cognitive decline relates to DHA status, with individuals with higher plasma DHA levels benefitting more from vitamin B12 and folic acid use. The results support earlier observations that positive effects of B-vitamins in cognitive ageing may be subgroup-specific.
TRIAL REGISTRATION


Registered at clinicaltrials.gov (NCT00696514) on June 12, 2008.",2022,There was no significant interaction between B-vitamin supplementation and combined omega-3 fatty acid (p = 0.49) and EPA (p = 0.99) tertiles.,"['daily for 2\xa0years', '191 adults aged 65\xa0years or older with baseline plasma total homocysteine\u2009≥\u200912\xa0μmol/L']","['combined omega-3 fatty acid', '400\xa0µg folic acid and 500\xa0µg vitamin B12 or placebo', 'B-vitamin supplementation', 'B-vitamin treatment', 'B-vitamins', 'vitamin supplementation']","['omega-3 fatty acid, DHA, or EPA plasma levels', 'cognitive ageing', 'Global and domain-specific cognitive functioning', 'global cognition', 'baseline plasma omega-3 fatty acids concentrations combined, and eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0302837', 'cui_str': 'Vitamin supplement agent'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",191.0,0.755973,There was no significant interaction between B-vitamin supplementation and combined omega-3 fatty acid (p = 0.49) and EPA (p = 0.99) tertiles.,"[{'ForeName': 'Annick P M', 'Initials': 'APM', 'LastName': 'van Soest', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, P.O. Box 12, 6700 AA, Wageningen, The Netherlands. annick.vansoest@wur.nl.'}, {'ForeName': 'Ondine', 'Initials': 'O', 'LastName': 'van de Rest', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, P.O. Box 12, 6700 AA, Wageningen, The Netherlands.'}, {'ForeName': 'Renger F', 'Initials': 'RF', 'LastName': 'Witkamp', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, P.O. Box 12, 6700 AA, Wageningen, The Netherlands.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Lisette C P G M', 'Initials': 'LCPGM', 'LastName': 'de Groot', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, P.O. Box 12, 6700 AA, Wageningen, The Netherlands.'}]",European journal of nutrition,['10.1007/s00394-022-02924-w']
1905,35704082,Is percutaneous nephrolithotomy effective and safe for children with solitary kidney?,"PURPOSE


To evaluate the safety and efficacy of percutaneous nephrolithotomy (PCNL) in pediatric patients with solitary kidneys and kidney stones.
METHODS


Thirty-nine patients (group A) with solitary kidney under 18 years of age who underwent PCNL between January 2015 and December 2021 were evaluated and analyzed. Forty-two patients (group B) with bilateral kidneys who underwent PCNL were determined as the control group and included in the analysis. Intraoperative and postoperative data such as demographic data, stone localization, bleeding and transfusion rates, operation time, complications, hospital stay, stone-free rates (SFR) and kidney function (glomerular filtration rate (eGFR)) were compared between the two groups. PCNL was performed with all patients in the prone position. Only a laser was used to fragment the stone in all cases. Stone-free was defined as the absence of residual stone fragments ≥ 2 mm in maximum diameter at 3 months on kidney, ureter and bladder (KUB) graphy, ultrasonography (US) or non-contrast tomography (NCCT).
RESULTS


The mean ages of the patients in Group A and B were 7.5 ± 2.6 and 8.5 ± 3.1 years, respectively. The mean stone size was 16.5 ± 4.1 and 17.0 ± 3.2 mm in group A and group B, respectively (p = 0.49). SFR rates in Groups A and B were 97.4% and 95.2% (p = 1.00). There was no statistically significant difference in terms of the operation time, perioperative blood transfusion, hemoglobin decrease and Clavien grade 1 complication rates (p > 0.05). However, double-J (JJ) stent placement, duration of nephrostomy and hospital stay were longer in the solitary kidney group (p < 0.05). There was a significant improvement in creatinine and eGFR levels in both groups at the postoperative sixth month (p < 0.05).
CONCLUSION


Our results show that PCNL is a safe and effective method in pediatric patients with solitary kidneys.",2022,"There was no statistically significant difference in terms of the operation time, perioperative blood transfusion, hemoglobin decrease and Clavien grade 1 complication rates (p > 0.05).","['Thirty-nine patients (group A) with solitary kidney under 18\xa0years of age who underwent PCNL between January 2015 and December 2021 were evaluated and analyzed', 'pediatric patients with solitary kidneys and kidney stones', 'pediatric patients with solitary kidneys', 'children with solitary kidney']","['percutaneous nephrolithotomy (PCNL', 'ultrasonography (US) or non-contrast tomography (NCCT', 'PCNL']","['creatinine and eGFR levels', 'mean stone size', 'operation time, perioperative blood transfusion, hemoglobin decrease and Clavien grade 1 complication rates', 'duration of nephrostomy and hospital stay', 'SFR rates', 'Intraoperative and postoperative data such as demographic data, stone localization, bleeding and transfusion rates, operation time, complications, hospital stay, stone-free rates (SFR) and kidney function (glomerular filtration rate (eGFR', 'safety and efficacy']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0266294', 'cui_str': 'Renal agenesis, unilateral'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}]","[{'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0278314', 'cui_str': 'Nephrostomy'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0244637,"There was no statistically significant difference in terms of the operation time, perioperative blood transfusion, hemoglobin decrease and Clavien grade 1 complication rates (p > 0.05).","[{'ForeName': 'Kadir', 'Initials': 'K', 'LastName': 'Karkin', 'Affiliation': 'Health Sciences University, Adana City Training and Research Hospital Urology Clinic, Adana, Turkey. kadir_karkin@msn.com.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Erçil', 'Affiliation': 'Health Sciences University, Adana City Training and Research Hospital Urology Clinic, Adana, Turkey.'}]",Pediatric surgery international,['10.1007/s00383-022-05147-6']
1906,35704055,Effect of a home-based resistance exercise program in elderly participants with osteoporosis: a randomized controlled trial.,"The effectiveness of home-based resistance exercise in elder participants with osteoporosis remains unclear. This study demonstrates the beneficial effects of this mode of exercise on improving physical function, increasing confidence in exercise, and reducing fear of falling.
INTRODUCTION


This study aims to evaluate the effect of a home-based resistance exercise (HBRE) program versus control on physical function, exercise self-efficacy, falling efficacy, and health-related quality of life (HRQOL).
METHODS


This randomized controlled trial included 72 elderly participants with osteoporosis. Participants in the intervention group received a 12-week HBRE program, and the control group received usual care. The primary outcome was physical function, including muscle strength and balance ability; secondary outcomes were exercise self-efficacy, falling efficacy, and HRQOL. Within-group and between-group changes in outcome were evaluated by t-test and rank-sum test.
RESULTS


A total of 68 subjects were included in the final analysis. Improvement in physical function was significantly greater in the HBRE group compared with controls. On a psychological level, exercise self-efficacy and falling efficacy improved significantly in the HBRE group; no significant change was observed in the control group. Most of the dimensions of HRQOL demonstrated improvements as well. The adherence was 85.29%, with no adverse events related to the exercise.
CONCLUSION


A 12-week HBRE program was safe non-pharmacological therapy for elderly participants with osteoporosis, improving physical function, exercise self-efficacy, reduced fear of falling, and improved HRQOL.
TRIAL REGISTRATION


Chinese Clinical Trial Register: ChiCTR2100051455. Registered 23.09.21. Retrospectively registered.",2022,"On a psychological level, exercise self-efficacy and falling efficacy improved significantly in the HBRE group; no significant change was observed in the control group.","['elder participants with osteoporosis', 'elderly participants with osteoporosis', 'A total of 68 subjects were included in the final analysis', '72 elderly participants with osteoporosis']","['home-based resistance exercise program', 'HBRE program', '12-week HBRE program, and the control group received usual care', 'home-based resistance exercise', 'home-based resistance exercise (HBRE) program', 'HBRE']","['physical function, including muscle strength and balance ability; secondary outcomes were exercise self-efficacy, falling efficacy, and HRQOL', 'physical function, exercise self-efficacy, falling efficacy, and health-related quality of life (HRQOL', 'physical function, exercise self-efficacy, reduced fear of falling, and improved HRQOL', 'physical function, increasing confidence in exercise, and reducing fear of falling', 'psychological level, exercise self-efficacy and falling efficacy', 'physical function']","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",72.0,0.0210953,"On a psychological level, exercise self-efficacy and falling efficacy improved significantly in the HBRE group; no significant change was observed in the control group.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Oncology, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedic Surgery, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopedic Surgery, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Nursing, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. lhhlky@163.com.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-022-06456-1']
1907,35704027,Metabolomic changes upon conjugated linoleic acid supplementation and predictions of body composition responsiveness.,"CONTEXT


Conjugated linoleic acid (CLA) may optimize body composition, yet mechanisms underlining its benefits were not clear in human.
OBJECTIVE


To reveal the CLA-induced changes in plasma metabolome associated with body composition improvement and the predictive performance of baseline metabolome on intervention responsiveness.
METHODS


Plasma metabolome from overnight fasted samples at pre- and post-intervention of 65 participants in a 12-week randomized, placebo-controlled trial (3.2 g/day CLA vs. 3.2 g/day sunflower oil) were analyzed using untargeted LC-MS metabolomics. Mixed linear model and machine learning were applied to assess differential metabolites between treatments, and to identify optimal panel (based on baseline conventional variables vs. metabolites) predicting responders of CLA-derived body composition improvement (increased muscle variables or decreased adiposity variables) based on dual-energy X-ray absorptiometry.
RESULTS


Compared to placebo, CLA altered 57 metabolites (P < 0.10) enriched in lipids/lipid-like molecules including glycerophospholipids (n=7), fatty acyls (n=6), sphingolipids (n=3). CLA-upregulated cholic acid (or downregulated aminopyrrolnitrin) was inversely correlated with changes in muscle and adiposity variables. Inter-individual variability in response to CLA-derived body composition change. The areas under the receiver operator characteristics curves of optimal metabolite panels were higher than that of optimal conventional panels in predicting favorable responders of waist circumference (0.93 [0.82-1.00] vs 0.64 [0.43-0.85]), visceral adiposity index (0.95 [0.88-1.00] vs 0.58 [0.35-0.80]), appendicular fat mass (0.97 [0.92-1.00] vs 0.73 [0.55-0.91]) upon CLA supplementation (all FDR P<0.05).
CONCLUSIONS


Post-intervention metabolite alterations were identified, involving in lipid/energy metabolism, associated with body composition changes. Baseline metabolite profiling enhanced the prediction accuracy on responsiveness of CLA-induced body composition benefits.",2022,"Compared to placebo, CLA altered 57 metabolites (P < 0.10) enriched in lipids/lipid-like molecules including glycerophospholipids (n=7), fatty acyls (n=6), sphingolipids (n=3).",['Plasma metabolome from overnight fasted samples at pre- and post-intervention of 65 participants'],"['Conjugated linoleic acid (CLA', 'placebo', 'conjugated linoleic acid supplementation', 'placebo, CLA']","['CLA-upregulated cholic acid', 'visceral adiposity index', 'body composition responsiveness', 'waist circumference', 'appendicular fat mass']","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0008404', 'cui_str': 'Cholalic Acids'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",65.0,0.125402,"Compared to placebo, CLA altered 57 metabolites (P < 0.10) enriched in lipids/lipid-like molecules including glycerophospholipids (n=7), fatty acyls (n=6), sphingolipids (n=3).","[{'ForeName': 'Yafang', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Key Laboratory for Disease Prevention and Control and Health Promotion of Shaanxi Province, Department of Epidemiology and Biostatistics, School of Public Health, Global Health Institute, Xi'an Jiaotong University Health Science Center, Xi'an, 710061, China.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': ""Key Laboratory for Disease Prevention and Control and Health Promotion of Shaanxi Province, Department of Epidemiology and Biostatistics, School of Public Health, Global Health Institute, Xi'an Jiaotong University Health Science Center, Xi'an, 710061, China.""}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Key Laboratory for Disease Prevention and Control and Health Promotion of Shaanxi Province, Department of Epidemiology and Biostatistics, School of Public Health, Global Health Institute, Xi'an Jiaotong University Health Science Center, Xi'an, 710061, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': ""Department of Clinical Nutrition, The Affiliated Hospital of Northwest University, Xi'an No.3 Hospital, Xi'an, 710032 China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': ""Department of Nutrition, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Cardiovascular Medicine, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Tian', 'Affiliation': ""Department of Nutrition, Xi'an Daxing Hospital, Xi'an, 710016, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Key Laboratory for Disease Prevention and Control and Health Promotion of Shaanxi Province, Department of Epidemiology and Biostatistics, School of Public Health, Global Health Institute, Xi'an Jiaotong University Health Science Center, Xi'an, 710061, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Key Laboratory for Disease Prevention and Control and Health Promotion of Shaanxi Province, Department of Epidemiology and Biostatistics, School of Public Health, Global Health Institute, Xi'an Jiaotong University Health Science Center, Xi'an, 710061, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Key Laboratory for Disease Prevention and Control and Health Promotion of Shaanxi Province, Department of Epidemiology and Biostatistics, School of Public Health, Global Health Institute, Xi'an Jiaotong University Health Science Center, Xi'an, 710061, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Key Laboratory for Disease Prevention and Control and Health Promotion of Shaanxi Province, Department of Epidemiology and Biostatistics, School of Public Health, Global Health Institute, Xi'an Jiaotong University Health Science Center, Xi'an, 710061, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""School of Food Engineering and Nutritional Science, Shaanxi Normal University, Xi'an 710119, China.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac367']
1908,35703895,Implementation of a Mobile Technology-Supported Diaphragmatic Breathing Intervention in Military mTBI With PTSD.,"BACKGROUND


Diaphragmatic breathing is an evidence-based intervention for managing stress and anxiety; however, some military veterans with mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) report challenges to learning and practicing the technique. BreatheWell Wear assists performance of breathing exercises through reminders, biofeedback, and visual, tactile, and auditory guidance.
OBJECTIVE


To evaluate feasibility of implementing BreatheWell Wear, a mobile smartwatch application with companion smartphone app, as an intervention for stress management in military veterans with mTBI and PTSD.
METHODS


Thirty veterans with chronic symptoms of mTBI and PTSD recruited from an interdisciplinary, intensive outpatient program participated in this pilot pragmatic clinical trial. Participants were randomly assigned to the experimental (BreatheWell Wear and conventional care) and control (conventional care) groups for 4 weeks. Conventional care included instruction on relaxation breathing and participation in behavioral health therapy. Effects on goal attainment, treatment adherence, diaphragmatic breathing technique knowledge, and stress were measured through surveys and diaries. Changes in symptoms, mood, and well-being were measured pre/postintervention via the Posttraumatic Checklist for DSM-5, Beck Anxiety Inventory, Beck Depression Inventory, and Flourishing Scale.
RESULTS


Person-centered goal attainment (t = 4.009, P < .001), treatment adherence (t = 2.742, P = .001), diaphragmatic breathing technique knowledge (t = 1.637, P < .001), and reported ease of remembering to practice (t = -3.075, P = .005) were significantly greater in the experimental group. As expected, measures of PTSD, anxiety, depression, and psychological well-being showed clinically meaningful change in both groups, and both groups demonstrated reduced stress following diaphragmatic breathing.
CONCLUSION


These preliminary findings indicate that BreatheWell Wear may be a clinically feasible tool for supporting diaphragmatic breathing as an intervention in veterans with mTBI and PTSD, and a future effectiveness trial is warranted.",2022,"As expected, measures of PTSD, anxiety, depression, and psychological well-being showed clinically meaningful change in both groups, and both groups demonstrated reduced stress following diaphragmatic breathing.
","['Military mTBI With PTSD', 'Thirty veterans with chronic symptoms of mTBI and PTSD recruited from an interdisciplinary, intensive outpatient program participated in this pilot pragmatic clinical trial', 'military veterans with mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD', 'military veterans with mTBI and PTSD']","['Mobile Technology-Supported Diaphragmatic Breathing Intervention', 'experimental (BreatheWell Wear and conventional care) and control (conventional care', 'Conventional care included instruction on relaxation breathing and participation in behavioral health therapy', 'Diaphragmatic breathing']","['Changes in symptoms, mood, and well-being were measured pre/postintervention via the Posttraumatic Checklist for DSM-5, Beck Anxiety Inventory, Beck Depression Inventory, and Flourishing Scale', 'goal attainment, treatment adherence, diaphragmatic breathing technique knowledge, and stress', 'treatment adherence', 'PTSD, anxiety, depression, and psychological well-being showed clinically meaningful change', 'biofeedback, and visual, tactile, and auditory guidance', 'diaphragmatic breathing technique knowledge', 'ease of remembering to practice']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C3658215', 'cui_str': 'Practical Clinical Trials'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]",30.0,0.0227186,"As expected, measures of PTSD, anxiety, depression, and psychological well-being showed clinically meaningful change in both groups, and both groups demonstrated reduced stress following diaphragmatic breathing.
","[{'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Wallace', 'Affiliation': 'SHARE Military Initiative (Ms Wallace, Mr Glickstein, and Dr Gore), Crawford Research Institute (Ms Wallace and Drs Morris and Anderson), Shepherd Center, Atlanta, Georgia; and Department of Sociology, Georgia State University, Atlanta, Georgia (Dr Anderson).'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Glickstein', 'Affiliation': ''}, {'ForeName': 'Raeda K', 'Initials': 'RK', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Russell K', 'Initials': 'RK', 'LastName': 'Gore', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000774']
1909,35703882,Can β-blockers influence regular daily physical activity?,"BACKGROUND


In hypertension, β-blockers have a high rate of nonadherence to treatment likely because of fatigue.
METHODS


We evaluate daily physical activity and maximal exercise performance in 56 patients with hypertension (grades I-II), with and without β-blockers (bisoprolol 10 mg or atenolol 100 mg) added to standard treatment; 48 patients completed the study. Study tests were performed after 8 weeks of antihypertensive therapy without β blockers and after the following 8 weeks with β-blockers.
RESULTS


No significant differences between β-blockers were observed. At office measurement, β-blockers decreased heart rate (HR) from 78 ± 9 to 62 ± 7 bpm (P < 0.01) and SBP from 133 ± 13 to 125 ± 12 mmHg (P < 0.01). No significant changes were observed for DBP. Conversely, at ambulatory pressure monitoring DBP but not SBP decreased with β-blockers (mean-24-h DBP 77 ± 8 vs. 74 ± 7 mmHg, P < 0.01). An overall reduction of daily activities and of estimated kilocalories consumption was observed as measured by a portable armband device. Of note, time with activity more than 3 METS was reduced by β-blockers from 148.1 (83-201) to 117.9 (82-189) min (P < 0.01). Cardiopulmonary exercise (CPE) showed a preserved exercise performance unaffected by β-blockers.
CONCLUSION


In hypertension, β-blocker treatment is associated to reduction of daily physical activity but not of maximal exercise performance.",2022,An overall reduction of daily activities and of estimated kilocalories consumption was observed as measured by a portable armband device.,"['56 patients with hypertension (grades I-II), with and without', '100\u200amg) added to standard treatment; 48 patients completed the study']","['Cardiopulmonary exercise (CPE', 'antihypertensive therapy without β blockers', 'β-blockers (bisoprolol 10\u200amg or atenolol']","['daily physical activity', 'heart rate (HR', 'daily physical activity and maximal exercise performance', 'DBP', 'daily activities and of estimated kilocalories consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",56.0,0.0185307,An overall reduction of daily activities and of estimated kilocalories consumption was observed as measured by a portable armband device.,"[{'ForeName': 'Marina Luisa', 'Initials': 'ML', 'LastName': 'Alimento', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Palermo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS.'}, {'ForeName': 'Gianpiero', 'Initials': 'G', 'LastName': 'Italiano', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Antonioli', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Salvioni', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS.'}, {'ForeName': 'Piergiuseppe', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS.'}]",Journal of hypertension,['10.1097/HJH.0000000000003130']
1910,35703877,Inter-individual variations in response to aerobic and resistance training in hypertensive older adults.,"BACKGROUND


Hemodynamic responses to physical training are not homogenous and uniform, and considerable inter-individual variations in the blood pressure of hypertensive individuals are noted in both aerobic and resistance training protocols. In this context, this study aimed to evaluate the effects of resistance and aerobic exercise on the blood pressure responses of hypertensive older adults.
METHODS


Groups were randomly divided into resistance training, n = 20; aerobic training, n = 20; control group, n = 21). After the first intervention period (12 weeks), individuals underwent a washout period (six detraining weeks), followed by a second intervention. This process is called the 'cross-over' model, where individuals who performed the aerobic exercise protocol also performed resistance training and vice-versa, constituting another 12 weeks of intervention. Blood pressure, functional performance, glycated hemoglobin and lipid profiles were evaluated preintervention and postintervention.
RESULTS


Varying responses to resistance training or aerobic training stimuli were observed in the hypertensive older adult participants. Both resistance training (pre 133.2 ± 14.1; post 122.4 ± 7.3; P < 0.05) and aerobic training (pre 134.2 ± 14.4; post 123 ± 9.4; P < 0.0.5) were effective in decreasing SBP, but only aerobic training (pre 9955.3 ± 1769.4; post 8800.9 ± 1316.1; P < 0.05) resulted in a decreased double product, and only the resistance training group improved functional performance.
CONCLUSION


Responses to resistance training or aerobic training stimuli varied noticeably between hypertensive older adults and both resistance training and aerobic training were effective in reducing SBP. This knowledge may be useful in providing individually tailored exercise prescriptions for hypertensive older adults.",2022,"Both resistance training (pre 133.2 ± 14.1; post 122.4 ± 7.3; P < 0.05) and aerobic training (pre 134.2 ± 14.4; post 123 ± 9.4; P < 0.0.5) were effective in decreasing SBP, but only aerobic training (pre 9955.3 ± 1769.4; post 8800.9 ± 1316.1; P < 0.05) resulted in a decreased double product, and only the resistance training group improved functional performance.
","['hypertensive older adults', 'Groups were randomly divided into', 'hypertensive older adult participants']","['resistance training, n\u200a=\u200a20; aerobic training, n\u200a=\u200a20; control group, n\u200a=\u200a21', 'resistance and aerobic exercise', 'physical training', 'aerobic and resistance training', 'resistance training or aerobic training stimuli']","['Blood pressure, functional performance, glycated hemoglobin and lipid profiles', 'blood pressure responses', 'SBP', 'functional performance']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",,0.00418478,"Both resistance training (pre 133.2 ± 14.1; post 122.4 ± 7.3; P < 0.05) and aerobic training (pre 134.2 ± 14.4; post 123 ± 9.4; P < 0.0.5) were effective in decreasing SBP, but only aerobic training (pre 9955.3 ± 1769.4; post 8800.9 ± 1316.1; P < 0.05) resulted in a decreased double product, and only the resistance training group improved functional performance.
","[{'ForeName': 'Odilon', 'Initials': 'O', 'LastName': 'Abrahin', 'Affiliation': 'Programa de Pós-Graduação em Genética e Biologia Molecular, Universidade Federal do Pará - UFPA.'}, {'ForeName': 'Rejane Pequeno', 'Initials': 'RP', 'LastName': 'Abrahin', 'Affiliation': 'Programa de Pós-Graduação em Genética e Biologia Molecular, Universidade Federal do Pará - UFPA.'}, {'ForeName': 'Evitom Corrêa', 'Initials': 'EC', 'LastName': 'de Sousa', 'Affiliation': 'Laboratório de Exercício Resistido e Saúde (LERES), Universidade do Estado Pará - UEPA, Belém, PA.'}, {'ForeName': 'Erik Artur', 'Initials': 'EA', 'LastName': 'Cortinhas-Alves', 'Affiliation': 'Laboratório de Exercício Resistido e Saúde (LERES), Universidade do Estado Pará - UEPA, Belém, PA.'}, {'ForeName': 'Dahan da Cunha', 'Initials': 'DDC', 'LastName': 'Nascimento', 'Affiliation': 'Departamento de Educação Física, Universidade Católica de Brasília (UCB), Brasília, DF, Brazil.'}, {'ForeName': 'João Farias', 'Initials': 'JF', 'LastName': 'Guerreiro', 'Affiliation': 'Programa de Pós-Graduação em Genética e Biologia Molecular, Universidade Federal do Pará - UFPA.'}]",Journal of hypertension,['10.1097/HJH.0000000000003139']
1911,35704329,Topical Ocular Anti-TNFα Agent Licaminlimab in the Treatment of Acute Anterior Uveitis: A Randomized Phase II Pilot Study.,"Purpose


Licaminlimab is a new anti-TNFα antibody fragment for topical ocular application. This phase II study assessed the tolerability, treatment effect, and pharmacokinetics of licaminlimab in acute anterior uveitis (AAU).
Methods


In this multicenter, randomized, parallel-group, double-masked study, 43 adult patients with non-infectious AAU and Standardization of Uveitis Nomenclature (SUN) anterior chamber (AC) cell score of 2+ or 3+ were randomized (3:1 ratio) to licaminlimab (60 mg/mL, 8 drops/day for 15 days, 4 drops/day for 7 days, then matching vehicle for 7 days) or dexamethasone eye drops (8 drops/day for 15 days, tapering to 1 drop/day over 14 days). The primary efficacy end point was clinical response (≥2-step decrease in AC cell grade at day 15). A treatment effect was considered as established if the lower limit of the 95% posterior interval of the responder rate was >30%. Serum levels of licaminlimab were determined.
Results


The day 15 response rate for licaminlimab was 56%; the lower bound of the 95% credible interval was 40% (i.e. >30%), demonstrating a treatment effect according to prespecified criteria. By day 4, 36% of licaminlimab-treated patients were responders; 76% had an AC cell grade of 0 on ≥1 post-treatment visit. The day 15 dexamethasone response rate was 90% (no inferential between-arm comparison was planned). Both treatments were well-tolerated. Intraocular pressure increased from baseline with dexamethasone but not licaminlimab. Licaminlimab was undetectable in serum in most patients.
Conclusions


Licaminlimab is the first biologic demonstrated to have a treatment effect on an intraocular condition with topical ocular application. The trial met its primary objective and the observed responder rate for licaminlimab was 56.0%. Ocular administration of licaminlimab was well-tolerated in adult subjects with AAU for up to 35 days.",2022,"The day 15 response rate for licaminlimab was 56%; the lower bound of the 95% credible interval was 40% (i.e. >30%), demonstrating a treatment effect according to prespecified criteria.","['adult subjects with AAU for up to 35 days', '43 adult patients with non-infectious AAU and Standardization of Uveitis Nomenclature (SUN) anterior chamber (AC) cell score of 2+ or 3', 'Acute Anterior Uveitis', 'acute anterior uveitis (AAU']","['dexamethasone', 'dexamethasone eye drops', 'Topical Ocular Anti-TNFα Agent Licaminlimab', 'Licaminlimab', 'licaminlimab']","['tolerated', 'Intraocular pressure', 'Serum levels of licaminlimab', 'Licaminlimab', 'dexamethasone response rate', 'response rate for licaminlimab', 'clinical response (≥2-step decrease in AC cell grade']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701807', 'cui_str': 'Acute anterior uveitis'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0600281', 'cui_str': 'Nomenclature'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0304706', 'cui_str': 'Dexamethasone-containing product in ocular dose form'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0423282', 'cui_str': 'Anterior chamber cells'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",43.0,0.131062,"The day 15 response rate for licaminlimab was 56%; the lower bound of the 95% credible interval was 40% (i.e. >30%), demonstrating a treatment effect according to prespecified criteria.","[{'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Pasquali', 'Affiliation': 'SoCal Eye, Lakewood Eye Physicians, Lakewood, CA, USA.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Toyos', 'Affiliation': 'Toyos Clinic, Nashville, TN, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Abrams', 'Affiliation': 'San Antonio Eye Center, San Antonio, TX, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Scales', 'Affiliation': 'Retina and Uveitis Consultants of Texas, San Antonio, TX, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Seaman', 'Affiliation': 'Novartis Pharmaceuticals Corporation, Fort Worth, TX, USA.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Weissgerber', 'Affiliation': 'Novartis Institutes for Biological Research, Basel, Switzerland.'}]",Translational vision science & technology,['10.1167/tvst.11.6.14']
1912,35704302,Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.,"Importance


Urinary catheters are commonly placed during laparoscopic inguinal hernia repair as a presumed protection against postoperative urinary retention (PUR), one of the most common complications following this operation. Data from randomized clinical trials evaluating the effect of catheters on PUR are lacking.
Objective


To investigate the effect of intraoperative catheters on PUR after laparoscopic inguinal hernia repair.
Design, Setting, and Participants


This 2-arm registry-based single-blinded randomized clinical trial was conducted at 6 academic and community hospitals in the US from March 2019 to March 2021 with a 30-day follow-up period following surgery. All patients who presented with inguinal hernias were assessed for eligibility, 534 in total. Inclusion criteria were adult patients undergoing laparoscopic, elective, unilateral, or bilateral inguinal hernia repair. Exclusion criteria were inability to tolerate general anesthesia and failure to understand and sign the written consent form. A total of 43 patients were excluded prior to intervention.
Interventions


Patients in the treatment arm had placement of a urinary catheter after induction of general anesthesia and removal at the end of procedure. Those in the control arm had no urinary catheter placement.
Main Outcomes and Measures


PUR rate.
Results


Of the 491 patients enrolled, 241 were randomized to catheter placement, and 250 were randomized to no catheter placement. The median (IQR) age was 61 (51-68) years, and 465 participants (94.7%) were male. Overall, 44 patients (9.1%) developed PUR. There was no difference in the rate of PUR between the catheter and no-catheter groups (23 patients [9.6%] vs 21 patients [8.5%], respectively; P = .79). There were no intraoperative bladder injuries. In the catheter group, there was 1 incident of postoperative urethral trauma in a patient who presented to the emergency department with PUR leading to a suprapubic catheter placement.
Conclusions and Relevance


Intraoperative urinary catheters did not reduce the risk of PUR after laparoscopic inguinal hernia repair. While their use did not appear to be associated with a high rate of iatrogenic complications, there may be a low rate of catastrophic complications. In patients who voided urine preoperatively, catheter placement did not appear to confer any advantage and thus their use may be reconsidered.
Trial Registration


ClinicalTrials.gov Identifier: NCT03835351.",2022,There were no intraoperative bladder injuries.,"['All patients who presented with inguinal hernias', 'The median (IQR) age was 61 (51-68) years, and 465 participants (94.7%) were male', 'Inclusion criteria were adult patients undergoing laparoscopic, elective, unilateral, or bilateral inguinal hernia repair', 'after laparoscopic inguinal hernia repair', 'After Laparoscopic Inguinal Hernia Repair', '6 academic and community hospitals in the US from March 2019 to March 2021 with a 30-day follow-up period following surgery', '43 patients were excluded prior to intervention', '491 patients enrolled, 241 were randomized to']","['Intraoperative Urinary Catheter Use', 'catheter placement', 'intraoperative catheters']","['intraoperative bladder injuries', 'PUR', 'risk of PUR', 'urinary catheter placement', 'Postoperative Urinary Retention', 'rate of PUR', 'Measures\n\n\nPUR rate', 'postoperative urethral trauma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0198737', 'cui_str': 'Bilateral inguinal hernia repair'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0403677', 'cui_str': 'Injury of bladder'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042019', 'cui_str': 'Catheterization, Urinary'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",43.0,0.575118,There were no intraoperative bladder injuries.,"[{'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Fafaj', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Center for Abdominal Core Health, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Lo Menzo', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Florida, Weston Hospital, Weston.'}, {'ForeName': 'Diya', 'Initials': 'D', 'LastName': 'Alaedeen', 'Affiliation': 'Department of General Surgery, Fairview Hospital, Cleveland, Ohio.'}, {'ForeName': 'Clayton C', 'Initials': 'CC', 'LastName': 'Petro', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Center for Abdominal Core Health, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Rosenblatt', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Center for Abdominal Core Health, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Szomstein', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Florida, Weston Hospital, Weston.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Massier', 'Affiliation': 'Department of General Surgery, Marymount Hospital, Garfield Heights, Ohio.'}, {'ForeName': 'Ajita S', 'Initials': 'AS', 'LastName': 'Prabhu', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Center for Abdominal Core Health, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Krpata', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Center for Abdominal Core Health, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Cha', 'Affiliation': 'Department of General Surgery, Hillcrest Hospital, Mayfield Heights, Ohio.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Montelione', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Center for Abdominal Core Health, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Tastaldi', 'Affiliation': 'Department of General Surgery, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Hemasat', 'Initials': 'H', 'LastName': 'Alkhatib', 'Affiliation': 'Department of General Surgery, MetroHealth System, Cleveland, Ohio.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Zolin', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Center for Abdominal Core Health, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Okida', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Florida, Weston Hospital, Weston.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rosen', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Center for Abdominal Core Health, The Cleveland Clinic Foundation, Cleveland, Ohio.'}]",JAMA surgery,['10.1001/jamasurg.2022.2205']
1913,35699737,Protocol for a Randomized Multiple Center Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children (Oxy-PICU): Oxygen in Paediatric Intensive Care.,"OBJECTIVES


Oxygen administration is a fundamental part of pediatric critical care, with supplemental oxygen offered to nearly every acutely unwell child. However, optimal targets for systemic oxygenation are unknown. Oxy-PICU aims to evaluate the clinical effectiveness and cost-effectiveness of a conservative peripheral oxygen saturation (Spo2) target of 88-92% compared with a liberal target of more than 94%.
DESIGN


Pragmatic, open, multiple-center, parallel group randomized control trial with integrated economic evaluation.
SETTING


Fifteen PICUs across England, Wales, and Scotland.
PATIENTS


Infants and children age more than 38 week-corrected gestational age to 16 years who are accepted to a participating PICU as an unplanned admission and receiving invasive mechanical ventilation with supplemental oxygen for abnormal gas exchange.
INTERVENTION


Adjustment of ventilation and inspired oxygen settings to achieve an Spo2 target of 88-92% during invasive mechanical ventilation.
MEASUREMENTS AND MAIN RESULTS


Randomization is 1:1 to a liberal Spo2 target of more than 94% or a conservative Spo2 target of 88-92% (inclusive), using minimization with a random component. Minimization will be performed on: age, site, primary reason for admission, and severity of abnormality of gas exchange. Due to the emergency nature of the treatment, approaching patients for written informed consent will be deferred to after randomization. The primary clinical outcome is a composite of death and days of organ support at 30 days. Baseline demographics and clinical status will be recorded as well as daily measures of oxygenation and organ support, and discharge outcomes. This trial received Health Research Authority approval on December 23, 2019 (reference: 272768), including a favorable ethical opinion from the East of England-Cambridge South Research Ethics Committee (reference number: 19/EE/0362). Trial findings will be disseminated in national and international conferences and peer-reviewed journals.",2022,"Adjustment of ventilation and inspired oxygen settings to achieve an Spo2 target of 88-92% during invasive mechanical ventilation.
","['Infants and children age more than 38 week-corrected gestational age to 16 years who are accepted to a participating PICU as an unplanned admission and receiving invasive mechanical ventilation with supplemental oxygen for abnormal gas exchange', 'Critically Ill Children (Oxy-PICU', 'Fifteen PICUs across England, Wales, and Scotland', '88-92% compared with a liberal target of more than 94']","['conservative peripheral oxygen saturation (Spo2', 'Conservative Versus Liberal Oxygenation Targets']","['clinical effectiveness and cost-effectiveness', 'composite of death and days of organ support at 30 days']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}]","[{'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.231325,"Adjustment of ventilation and inspired oxygen settings to achieve an Spo2 target of 88-92% during invasive mechanical ventilation.
","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Chang', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Lauran', 'Initials': 'L', 'LastName': ""O'Neill Gutierrez"", 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Agbeko', 'Affiliation': ""Department of Paediatric Intensive Care, Great North Children's Hospital, The Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.""}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Au', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Draper', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Gareth A L', 'Initials': 'GAL', 'LastName': 'Jones', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Lee Elliot', 'Initials': 'LE', 'LastName': 'Major', 'Affiliation': 'Parent Representative, United Kingdom.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Orzol', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pappachan', 'Affiliation': 'Paediatric Intensive Care Unit, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Padmanabhan', 'Initials': 'P', 'LastName': 'Ramnarayan', 'Affiliation': ""Children's Acute Transport Service, Great Ormond Street Hospital for Children NHS Foundation Trust and NIHR Biomedical Research Centre, London, United Kingdom.""}, {'ForeName': 'Samiran', 'Initials': 'S', 'LastName': 'Ray', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Sadique', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Doug W', 'Initials': 'DW', 'LastName': 'Gould', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000003008']
1914,35699713,Effect of Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care on Self-harm Among Adults With Suicidal Ideation.,,2022,,['Adults With Suicidal Ideation'],['Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care'],['Self-harm'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]",,0.00360009,,"[{'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'University of Memphis, Memphis, Tennessee.'}]",JAMA,['10.1001/jama.2022.5874']
1915,35699712,Effect of Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care on Self-harm Among Adults With Suicidal Ideation.,,2022,,['Adults With Suicidal Ideation'],['Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care'],['Self-harm'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]",,0.00360009,,"[{'ForeName': 'Ching-Fang', 'Initials': 'CF', 'LastName': 'Sun', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Carilion Clinic, Virginia Tech Carilion School of Medicine, Roanoke.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Trestman', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Carilion Clinic, Virginia Tech Carilion School of Medicine, Roanoke.'}]",JAMA,['10.1001/jama.2022.5877']
1916,35699711,Effect of Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care on Self-harm Among Adults With Suicidal Ideation.,,2022,,['Adults With Suicidal Ideation'],['Care Management or Online Dialectical Behavior Therapy Skills Training vs Usual Care'],['Self-harm'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]",,0.00360009,,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Weinberg', 'Affiliation': 'Ellenhorn LLC, Arlington, Massachusetts.'}]",JAMA,['10.1001/jama.2022.5880']
1917,35700035,Internet-Based Prevention Program of Victimization for Youth in Care and Care Leavers (EMPOWER YOUTH): Protocol for a Randomized Controlled Trial.,"BACKGROUND


The global estimate of the number of children in institutional care is around 5 million, with around 1 million of these children living in Europe. In Germany, about 75,000 children and adolescents find themselves in the foster care system and about 93,000 additional children and adolescents are living in institutions. Traumatic experiences and neglect in childhood are highly prevalent among these youth in care and are related to severe long-term effects. Childhood maltreatment and abuse can increase the risk of future victimization experiences. Although youth in care are at risk of victimization or revictimization, no specific evidence-based prevention program has been designed to address these specific needs.
OBJECTIVE


This study aims to evaluate the efficacy of a newly developed 6-module internet-based prevention program of victimization for youth in care, named EMPOWER YOUTH.
METHODS


In a randomized controlled trial, the intervention group will be compared to a waiting-list control group with an unblinded 1:1 allocation ratio. Assessments will take place before randomization (baseline) and at follow-up 18 weeks after baseline (ie, 12 weeks after finishing the last module of the program). The primary endpoint is the number of victimization, and online and offline bullying experiences (composite score) at the 18-week follow-up. Secondary endpoints are risk-taking behavior, aggressive tendencies, empathy, prosocial behavior, depressiveness, and loneliness at follow-up. The expected outcome requires a sample size of 156 subjects to achieve a power of 80%. Assuming a 30% dropout rate at follow-up, we require 225 participants to be allocated to the trial. Participants are youth in care, that is, adolescents in foster care, adopted adolescents, or young care leavers aged 14 to 21 years.
RESULTS


Ethical approval was granted by the Ethics Committee of the Medical School Berlin in March 2021 (MSB-2021/55). Recruitment started in September 2021 and is planned until November 2022. The results are expected to be published in January 2023.
CONCLUSIONS


Given the increased likelihood for future victimization experiences among youth in care, there is a strong need for a low-threshold intervention specifically for this high-risk age group. There are no existing nationwide mental health programs exclusively for youth in care in Germany.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00024749; https://tinyurl.com/tjaahayw.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/34706.",2022,"The primary endpoint is the number of victimization, and online and offline bullying experiences (composite score) at the 18-week follow-up.","['93,000 additional children and adolescents are living in institutions', 'Participants are youth in care, that is, adolescents in foster care, adopted adolescents, or young care leavers aged 14 to 21 years', '75,000 children and adolescents', 'children living in Europe']","['6-module internet-based prevention program of victimization', 'Internet-Based Prevention Program of Victimization']","['number of victimization, and online and offline bullying experiences (composite score', 'risk-taking behavior, aggressive tendencies, empathy, prosocial behavior, depressiveness, and loneliness at follow-up']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4749226', 'cui_str': 'Aging out of youth care system'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",75000.0,0.238059,"The primary endpoint is the number of victimization, and online and offline bullying experiences (composite score) at the 18-week follow-up.","[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Department of Psychology, Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Reuter', 'Affiliation': 'Department of Psychology, Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Betteke Maria', 'Initials': 'BM', 'LastName': 'van Noort', 'Affiliation': 'Department of Psychology, Medical School Berlin, Berlin, Germany.'}]",JMIR research protocols,['10.2196/34706']
1918,35700026,A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Diabetes self-management education and support (DSMES) is a crucial component of diabetes care associated with improved clinical, psychosocial, and behavioral outcomes. The American Association of Diabetes Care and Education Specialists, the American Diabetes Association, and the American Academy of Family Physicians all recommend DSMES yet accessing linguistically and culturally appropriate DSMES is challenging in rural areas. The Diabetes One-Day (D1D) program is an established DSMES group intervention that has not been adapted or evaluated in rural communities.
OBJECTIVE


The specific aims of this paper are (1) to adapt the existing D1D program for use in rural communities, called rural D1D (R-D1D); and (2) to conduct a patient-level randomized controlled trial to examine the effects of R-D1D and standard patient education, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework.
METHODS


This is a protocol for a pilot type II hybrid implementation-effectiveness trial of a culturally adapted virtual DSMES program for rural populations, R-D1D. We will use Boot Camp Translation, a process grounded in the principles of community-based participatory research, to adapt an existing DSMES program for rural populations, in both English and Spanish. Participants at 2 rural primary care clinics (4 cohorts of N=16 plus care partners, 2 in English and 2 in Spanish) will be randomized to the intervention or standard education control. The evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Patient-level effectiveness outcomes (hemoglobin A 1c , diabetes distress, and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A 1c  test kit. Practice-level and patient-level acceptability and feasibility will be assessed using surveys and interviews.
RESULTS


This study is supported by the National Institute of Nursing. The study procedures were approved, and the adaptation processes have been completed. Recruitment and enrollment started in July 2021.
CONCLUSIONS


To our knowledge, this will be the first study to evaluate both effectiveness and implementation outcomes for virtually delivered DSMES, culturally adapted for rural populations. This research has implications for delivery to other rural locations where access to specialty diabetes care is limited.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04600622; https://clinicaltrials.gov/ct2/show/NCT04600622.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/34255.",2022,"Patient-level effectiveness outcomes (hemoglobin A 1c , diabetes distress, and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A 1c  test kit.","['Participants at 2 rural primary care clinics (4 cohorts of N=16 plus care partners, 2 in English and 2 in Spanish', 'Rural Populations', 'rural communities, called rural D1D (R-D1D', 'rural populations, R-D1D']","['culturally adapted virtual DSMES program', 'intervention or standard education control']","['Patient-level effectiveness outcomes (hemoglobin A 1c , diabetes distress, and diabetes self-care behaviors']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}]",,0.065382,"Patient-level effectiveness outcomes (hemoglobin A 1c , diabetes distress, and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A 1c  test kit.","[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Litchman', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Kwan', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zittleman', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Simonetti', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Iacob', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Curcija', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Neuberger', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Latendress', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Tamara K', 'Initials': 'TK', 'LastName': 'Oser', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}]",JMIR research protocols,['10.2196/34255']
1919,35700023,Impact of a Papillomavirus Vaccination Promotion Program in Middle School: Study Protocol for a Cluster Controlled Trial.,"BACKGROUND


On Reunion Island, incidence and mortality for uterine cervical cancer is high, yet coverage rate for human papillomavirus (HPV) vaccination is low.
OBJECTIVE


The main objective of the study is to evaluate the impact of a health promotion program promoting HPV vaccination on the proportion of middle school girls who complete the full HPV vaccination schedule (2 or 3 doses) by the end of school year.
METHODS


This study is a cluster controlled intervention study using a superiority design. A combined health promotion program will be offered containing information to students and parents, training of general practitioners, and free school-based vaccination (in a ""health bus""). Children who attend this program will constitute the intervention group and will be compared to children from another middle school who will not attend the program constituting the control group.
RESULTS


Recruitment began in October 2020. In the intervention school, of 780 students, 245 were randomly selected in the 12 classes. In the control school, 259 students out of 834 were randomly selected.
CONCLUSIONS


In this study, we explore the impact of a health promotion program combining information toward students, parents, and general practitioners with free school-based vaccination. We expect a significantly higher HPV vaccination coverage in the intervention school as compared to the control school, whether it be among girls or boys. The final implication would be an extension of this program in all middle schools on the Island and thus an increase in HPV vaccination coverage.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04459221; https://clinicaltrials.gov/ct2/show/NCT04459221.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/35695.",2022,"We expect a significantly higher HPV vaccination coverage in the intervention school as compared to the control school, whether it be among girls or boys.","['259 students out of 834 were randomly selected', 'middle school girls who complete the full HPV vaccination schedule (2 or 3 doses) by the end of school year', 'Middle School', 'toward students, parents, and general practitioners with free school-based vaccination', '780 students, 245 were randomly selected in the 12 classes']","['health promotion program combining information', 'Papillomavirus Vaccination Promotion Program', 'health promotion program promoting HPV vaccination']",['HPV vaccination coverage'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030358', 'cui_str': 'Genus Papillomavirus'}, {'cui': 'C4279932', 'cui_str': 'Vaccination Promotion'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}]",834.0,0.0530303,"We expect a significantly higher HPV vaccination coverage in the intervention school as compared to the control school, whether it be among girls or boys.","[{'ForeName': 'Phuong Lien', 'Initials': 'PL', 'LastName': 'Tran', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital of St Pierre, Saint Pierre, Réunion, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Chirpaz', 'Affiliation': 'Registre des Cancers, Centre Hospitalier Universitaire de La Réunion, St Denis, Réunion, France.'}, {'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Boukerrou', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital of St Pierre, Saint Pierre, Réunion, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Bertolotti', 'Affiliation': 'Department of Dermatology and Infectious Diseases, University Hospital of St Pierre, St Pierre, Réunion, France.'}]",JMIR research protocols,['10.2196/35695']
1920,35700020,"Impact of Web-Based Cognitive Behavioral Therapy for Insomnia on Stress, Health, Mood, Cognitive, Inflammatory, and Neurodegenerative Outcomes in Rural Dementia Caregivers: Protocol for the NiteCAPP CARES and NiteCAPP SHARES Randomized Controlled Trial.","BACKGROUND


Chronic insomnia affects up to 63% of family dementia caregivers. Research suggests that chronic insomnia prompts changes in central stress processing that have downstream negative effects on health and mood, as well as on cognitive, inflammatory, and neurodegenerative functioning. We hypothesize that cognitive behavioral therapy for insomnia (CBT-I) will reverse those downstream effects by improving insomnia and restoring healthy central stress processing. Rural caregivers are particularly vulnerable, but they have limited access to CBT-I; therefore, we developed an accessible digital version using community input (NiteCAPP CARES).
OBJECTIVE


This trial will evaluate the acceptability, feasibility, and short-term and long-term effects of NiteCAPP CARES on the sleep and stress mechanisms underlying poor caregiver health and functioning.
METHODS


Dyads (n=100) consisting of caregivers with chronic insomnia and their coresiding persons with dementia will be recruited from Columbia and surrounding areas in Missouri, United States. Participant dyads will be randomized to 4 weeks (plus 4 bimonthly booster sessions) of NiteCAPP CARES or a web-based sleep hygiene control (NiteCAPP SHARES). Participants will be assessed at baseline, after treatment, and 6- and 12-month follow-ups. The following assessments will be completed by caregivers: 1 week of actigraphy and daily diaries measuring sleep, Insomnia Severity Index, arousal (heart rate variability), inflammation (blood-derived biomarkers: interleukin-6 and C-reactive protein), neurodegeneration (blood-derived biomarkers: plasma amyloid beta [Aβ40 and Aβ42], total tau, and phosphorylated tau [p-tau181 and p-tau217]), cognition (Joggle battery, NIH Toolbox for Assessment of Neurological and Behavioral Function, and Cognitive Failures Questionnaire), stress and burden, health, and mood (depression and anxiety). Persons with dementia will complete 1 week of actigraphy at each time point.
RESULTS


Recruitment procedures started in February 2022. All data are expected to be collected by 2026. Full trial results are planned to be published by 2027. Secondary analyses of baseline data will be subsequently published.
CONCLUSIONS


This randomized controlled trial tests NiteCAPP CARES, a web-based CBT-I for rural caregivers. The knowledge obtained will address not only what outcomes improve but also how and why they improve and for how long, which will help us to modify NiteCAPP CARES to optimize treatment potency and support future pragmatic testing and dissemination.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04896775; https://clinicaltrials.gov/ct2/show/NCT04896775.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/37874.",2022,We hypothesize that cognitive behavioral therapy for insomnia (CBT-I) will reverse those downstream effects by improving insomnia and restoring healthy central stress processing.,"['Rural caregivers', 'Dyads (n=100) consisting of caregivers with chronic insomnia and their coresiding persons with dementia will be recruited from Columbia and surrounding areas in Missouri, United States', 'Rural Dementia Caregivers', 'rural caregivers', 'Persons with dementia']","['NiteCAPP CARES', 'NiteCAPP CARES or a web-based sleep hygiene control (NiteCAPP SHARES', 'cognitive behavioral therapy', 'Web-Based Cognitive Behavioral Therapy']","['Stress, Health, Mood, Cognitive, Inflammatory, and Neurodegenerative Outcomes', 'actigraphy and daily diaries measuring sleep, Insomnia Severity Index, arousal (heart rate variability), inflammation (blood-derived biomarkers: interleukin-6 and C-reactive protein), neurodegeneration (blood-derived biomarkers: plasma amyloid beta [Aβ40 and Aβ42], total tau, and phosphorylated tau [p-tau181 and p-tau217]), cognition (Joggle battery, NIH Toolbox for Assessment of Neurological and Behavioral Function, and Cognitive Failures Questionnaire), stress and burden, health, and mood (depression and anxiety']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0027746', 'cui_str': 'Nerve degeneration'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451082', 'cui_str': 'Cognitive failures questionnaire'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.28715,We hypothesize that cognitive behavioral therapy for insomnia (CBT-I) will reverse those downstream effects by improving insomnia and restoring healthy central stress processing.,"[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Cottle', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Beversdorf', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Shenker', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Mooney', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Mihail', 'Initials': 'M', 'LastName': 'Popescu', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Rantz', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Groer', 'Affiliation': 'University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Stein', 'Affiliation': 'Washington University, St Louis, MO, United States.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Golzy', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Stearns', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Angelynn', 'Initials': 'A', 'LastName': 'Simenson', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Neetu', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': 'University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Meredeth A', 'Initials': 'MA', 'LastName': 'Rowe', 'Affiliation': 'University of South Florida, Tampa, FL, United States.'}]",JMIR research protocols,['10.2196/37874']
1921,35699959,Efficacy of Mobile Instant Messaging-Delivered Brief Motivational Interviewing for Parents to Promote Physical Activity in Pediatric Cancer Survivors: A Randomized Clinical Trial.,"Importance


Physical activity has beneficial effects that mitigate cancer- and treatment-related late effects. However, children who survive cancer are often physically inactive. Brief motivational interviewing may be an effective approach for increasing children's physical activity levels.
Objective


To examine the effects of mobile instant messaging-delivered brief motivational interviewing for parents in promoting regular physical activity in children who have survived cancer.
Design, Setting, and Participants


An assessor-blinded randomized clinical trial was conducted at 2 Hong Kong pediatric oncology outpatient clinics from March 1, 2019, to January 29, 2021. A total of 161 children who had survived cancer, aged 9 to 16 years, and their parents were randomized (1:1) to an intervention or control group.
Interventions


The intervention group received a 6-month mobile instant messaging-delivered brief motivational interviewing using a strategy menu. Parent-child dyads in both groups received a health advice session and were directed to a physical activity website at baseline.
Main Outcomes and Measures


The primary outcome was the children's physical activity levels at 12-month follow-up, measured by the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth (total sores: 0-10, higher scores indicate greater physical activity levels). Secondary outcomes were cancer-related fatigue levels, handgrip strength, peak expiratory flow rate, and quality of life. Intention-to-treat analysis was performed.
Results


Of the 161 children included in the study, 93 were boys (57.8%), and the mean (SD) age was 12.4 (2.4) years. Generalized estimating equation analyses showed a significant improvement in outcomes in the intervention group compared with the control group: physical activity levels (group-by-time interaction, 6 months: β = 3.09; 95% CI, 2.65-3.53; P < .001; 12 months: β = 3.91; 95% CI, 3.45-4.36; P < .001), cancer-related fatigue (6 months: β = -5.69; 95% CI, -8.03 to -3.35; P < .001; 12 months: β = -9.16; 95% CI, -11.31 to -7.00; P < .001), left handgrip strength (6 months: β = 2.69; 95% CI, 0.96-4.43; P = .002; 12 months: β = 5.52; 95% CI, 3.70-7.33; P < .001), right handgrip strength (6 months: β = 2.75; 95% CI, 1.01-4.50; P = .002; 12 months: β = 5.45; 95% CI, 3.62-7.27; P < .001), peak expiratory flow rate (12 months: β = 28.51; 95% CI, 16.10-40.92; P < .001), and quality of life (6 months: β = 5.01; 95% CI, 1.19-8.82; P = .01); 12 months: β = 14.19; 95% CI, 10.84-17.54; P < .001).
Conclusions and Relevance


In this randomized clinical trial, mobile instant messaging-delivered brief motivational interviewing was effective in promoting the adoption and maintenance of regular physical activity and ameliorating cancer- or treatment-related adverse effects in children who survived cancer.
Trial Registration


ClinicalTrials.gov Identifier: NCT03859271.",2022,"Generalized estimating equation analyses showed a significant improvement in outcomes in the intervention group compared with the control group: physical activity levels (group-by-time interaction, 6 months: β = 3.09; 95% CI, 2.65-3.53; P < .001; 12 months: β = 3.91; 95% CI, 3.45-4.36; P < .001), cancer-related fatigue (6 months: β = -5.69; 95% CI, -8.03 to -3.35; P < .001; 12 months: β = -9.16; 95% CI, -11.31 to -7.00; P < .001), left handgrip strength (6 months: β = 2.69; 95% CI, 0.96-4.43; P = .002; 12 months: β = 5.52; 95% CI, 3.70-7.33; P < .001), right handgrip strength (6 months: β = 2.75; 95% CI, 1.01-4.50; P = .002; 12 months: β = 5.45; 95% CI, 3.62-7.27; P < .001), peak expiratory flow rate (12 months: β = 28.51; 95% CI, 16.10-40.92; P < .001), and quality of life (6 months: β = 5.01; 95% CI, 1.19-8.82; P = .01); 12 months: β = 14.19; 95% CI, 10.84-17.54; P < .001).
","['Pediatric Cancer Survivors', '2 Hong Kong pediatric oncology outpatient clinics from March 1, 2019, to January 29, 2021', '161 children included in the study, 93 were boys (57.8%), and the mean (SD) age was 12.4 (2.4) years', 'children who have survived cancer', '161 children who had survived cancer, aged 9 to 16 years, and their parents', 'children who survived cancer']","['mobile instant messaging-delivered brief motivational interviewing', 'Mobile Instant Messaging-Delivered Brief Motivational Interviewing', 'intervention or control group', 'Brief motivational interviewing', 'health advice session', '6-month mobile instant messaging-delivered brief motivational interviewing using a strategy menu']","[""children's physical activity levels"", 'peak expiratory flow rate', 'quality of life', 'Chinese University of Hong Kong: Physical Activity Rating for Children and Youth (total sores: 0-10, higher scores indicate greater physical activity levels', 'cancer-related fatigue levels, handgrip strength, peak expiratory flow rate, and quality of life', 'left handgrip strength', 'physical activity levels', 'right handgrip strength', 'cancer-related fatigue']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}]",161.0,0.308323,"Generalized estimating equation analyses showed a significant improvement in outcomes in the intervention group compared with the control group: physical activity levels (group-by-time interaction, 6 months: β = 3.09; 95% CI, 2.65-3.53; P < .001; 12 months: β = 3.91; 95% CI, 3.45-4.36; P < .001), cancer-related fatigue (6 months: β = -5.69; 95% CI, -8.03 to -3.35; P < .001; 12 months: β = -9.16; 95% CI, -11.31 to -7.00; P < .001), left handgrip strength (6 months: β = 2.69; 95% CI, 0.96-4.43; P = .002; 12 months: β = 5.52; 95% CI, 3.70-7.33; P < .001), right handgrip strength (6 months: β = 2.75; 95% CI, 1.01-4.50; P = .002; 12 months: β = 5.45; 95% CI, 3.62-7.27; P < .001), peak expiratory flow rate (12 months: β = 28.51; 95% CI, 16.10-40.92; P < .001), and quality of life (6 months: β = 5.01; 95% CI, 1.19-8.82; P = .01); 12 months: β = 14.19; 95% CI, 10.84-17.54; P < .001).
","[{'ForeName': 'Ankie Tan', 'Initials': 'AT', 'LastName': 'Cheung', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Sha Tin, Hong Kong.'}, {'ForeName': 'William Ho Cheung', 'Initials': 'WHC', 'LastName': 'Li', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Sha Tin, Hong Kong.'}, {'ForeName': 'Laurie Long Kwan', 'Initials': 'LLK', 'LastName': 'Ho', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Sha Tin, Hong Kong.'}, {'ForeName': 'Godfrey Chi-Fung', 'Initials': 'GC', 'LastName': 'Chan', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Huen Sum', 'Initials': 'HS', 'LastName': 'Lam', 'Affiliation': 'Hong Kong Council for Accreditation of Academic and Vocational Qualifications, Hong Kong.'}, {'ForeName': 'Joyce Oi Kwan', 'Initials': 'JOK', 'LastName': 'Chung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.14600']
1922,35699953,AVPCancerFree : Impact of a digital behavior change intervention on parental HPV vaccine -related perceptions and behaviors.,"Parent hesitancy contributes to reduced HPV vaccination rates. The HPVcancerfree app (HPVCF) was designed to assist parents in making evidence-based decisions regarding HPV vaccination. This study examined if parents of vaccine-eligible youth (11-12 yrs.) who use HPVCF in addition to usual care demonstrate significantly more positive intentions and attitudes toward HPV vaccination and greater HPV vaccination rates compared to those not using HPVCF. Clinics (n = 51) within a large urban pediatric network were randomly assigned to treatment (HPVCF + usual care) or comparison (usual care only) conditions in a RCT conducted between September 2017 and February 2019. Parents completed baseline and 5-month follow-up surveys. Participant-level analysis determined 1) change in HPV vaccination initiation behavior and related psychosocial determinants and 2) predictors of HPV vaccine initiation. Parents (n = 375) who completed baseline and 5-month follow-up surveys were female (95.2%), 40.8 (±5.8) yrs. married (83.7%), employed (68.3%), college educated (61.9%), and privately insured (76.5%). Between-group analysis of HPVCF efficacy demonstrated that parents assigned to receive HPVCF significantly increased knowledge about HPV and HPV vaccination ( p  < .05). Parents who accessed content within HPVCF significantly increased knowledge about HPV & HPV vaccine ( p  < .01) and perceived effectiveness of HPV vaccine ( p  < .05). Change in HPV vaccine initiation was not significant. A multivariate model to describe predictors of HPV vaccine initiation demonstrated an association with Tdap and MCV vaccination adoption, positive change in perceived effectiveness of the HPV vaccine, and reduction in perceived barriers against HPV vaccination. HPVCF appears to be a feasible adjunct to the education received in usual care visits and reinforces the value of apps to support the important persuasive voice of the health-care provider in overcoming parent HPV vaccine hesitancy.",2022,Between-group analysis of HPVCF efficacy demonstrated that parents assigned to receive HPVCF significantly increased knowledge about HPV and HPV vaccination ( p  < .05).,"['Clinics (n\u2009=\u200951) within a large urban pediatric network', 'parents of vaccine-eligible youth (11-12\u2009yrs.) who use', 'conducted between September 2017 and February 2019', 'Parents (n\u2009=\u2009375) who completed baseline and 5-month follow-up surveys were female (95.2%), 40.8 (±5.8) yrs', 'married (83.7%), employed (68.3%), college educated (61.9%), and privately insured (76.5', 'parental HPV vaccine -related perceptions and behaviors']","['HPVcancerfree app (HPVCF', 'AVPCancerFree ', 'HPVCF', 'treatment (HPVCF\u2009+\u2009usual care) or comparison (usual care only) conditions in a RCT', 'digital behavior change intervention']","['positive intentions and attitudes toward HPV vaccination and greater HPV vaccination rates', 'knowledge about HPV and HPV vaccination', 'effectiveness of HPV vaccine', 'HPV vaccination initiation behavior and related psychosocial determinants and 2) predictors of HPV vaccine initiation', 'HPVCF efficacy', 'HPV vaccination rates', 'knowledge about HPV & HPV vaccine']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0359378,Between-group analysis of HPVCF efficacy demonstrated that parents assigned to receive HPVCF significantly increased knowledge about HPV and HPV vaccination ( p  < .05).,"[{'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Shegog', 'Affiliation': 'Department of Behavioral Science, UTHealth School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Savas', 'Affiliation': 'Department of Behavioral Science, UTHealth School of Public Health, Houston, TX, USA.'}, {'ForeName': 'C Mary', 'Initials': 'CM', 'LastName': 'Healy', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Frost', 'Affiliation': 'Department of Behavioral Science, UTHealth School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Sharon P', 'Initials': 'SP', 'LastName': 'Coan', 'Affiliation': 'Department of Behavioral Science, UTHealth School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Efrat K', 'Initials': 'EK', 'LastName': 'Gabay', 'Affiliation': 'Department of Behavioral Science, UTHealth School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Sharice M', 'Initials': 'SM', 'LastName': 'Preston', 'Affiliation': 'Department of Behavioral Sciences, UTHealth School of Public Health, Dallas, TX, USA.'}, {'ForeName': 'Stanley W', 'Initials': 'SW', 'LastName': 'Spinner', 'Affiliation': ""Department of Pediatrics, Texas Children's Pediatrics, Houston, TX, USA.""}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Wilbur', 'Affiliation': ""Department of Pediatrics, Texas Children's Pediatrics, Houston, TX, USA.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Becker', 'Affiliation': 'Department of Behavioral Science, UTHealth School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Teague', 'Affiliation': 'Department of Behavioral Science, UTHealth School of Public Health, Houston, TX, USA.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Department of Behavioral Science, UTHealth School of Public Health, Houston, TX, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2087430']
1923,35699910,Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial.,"BACKGROUND/AIM


DARE-19 (NCT04350593) was a randomized trial studying the effects of dapagliflozin, an SGLT2 inhibitor, in hospitalized patients with COVID-19 pneumonia and cardiometabolic risk factors. The conduct of DARE-19 offered the opportunity to define an innovative and clinically meaningful endpoint in a new disease that would best reflect the known profile of dapagliflozin, accompanied by the statistical challenges of analysis and interpretation of such a novel endpoint.
METHODS


Hierarchical composite endpoints (HCEs) are based on clinical outcomes which, unlike traditional composite endpoints incorporate ranking of components according to clinical importance. Design of an HCE requires the clinical considerations specific to the therapeutic area under study and the mechanism of action of the investigational treatment. Statistical aspects for the clinical endpoints include the proper definition of the estimand as suggested by ICH E9(R1) for the precise specification of the treatment effect measured by an HCE.
RESULTS


We describe the estimand of the DARE-19 trial, where an HCE was constructed to capture the treatment effect of dapagliflozin in hospitalized patients with COVID-19, and was analyzed using a win odds. Practical aspects of designing new studies based on an HCE are described. These include sample size, power, and minimal detectable effect calculations for an HCE based on the win odds analysis, as well as handling of missing data and the clinical interpretability of the win odds in relation to the estimand.
CONCLUSIONS


HCEs are flexible endpoints that can be adapted for use in different therapeutic areas, with win odds as the analysis method. DARE-19 is an example of a COVID-19 trial with an HCE as one of the primary endpoints for estimating a clinically interpretable treatment effect in the COVID-19 setting.",2022,"METHODS


Hierarchical composite endpoints (HCEs) are based on clinical outcomes which, unlike traditional composite endpoints incorporate ranking of components according to clinical importance.","['hospitalized patients with COVID-19 pneumonia and cardiometabolic risk factors', 'hospitalized patients with COVID-19, and was analyzed using a win odds']","['dapagliflozin', 'HCE']",[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0062144', 'cui_str': '1,2,3,4,9,9-hexachloro-exo-5,6-epoxy-1,4,4a,5,6, 7,8,8a-octahydro-1,4-methanonaphthalene'}]",[],,0.220539,"METHODS


Hierarchical composite endpoints (HCEs) are based on clinical outcomes which, unlike traditional composite endpoints incorporate ranking of components according to clinical importance.","[{'ForeName': 'Samvel B', 'Initials': 'SB', 'LastName': 'Gasparyan', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. Samvel.gasparyan@astrazeneca.com.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Buenconsejo', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Elaine K', 'Initials': 'EK', 'LastName': 'Kowalewski', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Olof F', 'Initials': 'OF', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Esterline', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Koch', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Academic Research Organization (ARO), Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA.""}]",Therapeutic innovation & regulatory science,['10.1007/s43441-022-00420-1']
1924,35700209,"Impact of Integrated Water, Sanitation, Hygiene, Health and Nutritional Interventions on Diarrhoea Disease Epidemiology and Microbial Quality of Water in a Resource-Constrained Setting in Kenya: A Controlled Intervention Study.","OBJECTIVES


We assessed the impact of Water, Hygiene and Sanitation (WASH), Maternal, New-born and Child Health (MNCH), nutrition and Early Childhood Development (ECD) on diarrhoea and microbial quality of water in a resource-constrained rural setting in Kenya.
METHODS


Through a controlled intervention study, we tested faecal and water samples collected from both the intervention and control sites before and after the interventions using microbiological, immunological and molecular assays to determine the prevalence of diarrheagenic agents and microbial quality of water. Data from the hospital registers were used to estimate all-cause diarhoea prevalence.
RESULTS


After the interventions, we observed a 58.2% (95% CI: 39.4-75.3) decline in all-cause diarhoea in the intervention site vs. a 22.2% (95% CI: 5.9-49.4) reduction of the same in the control site. Besides rotavirus and pathogenic Escherichia coli, the rate of isolation of other diarrhoea-causing bacteria declined substantially in the intervention site. The microbial quality of community and household water improved considerably in both the intervention (81.9%; 95% CI: 74.5-87.8%) and control (72.5%; 95% CI: 64.2-80.5%) sites with the relative improvements in the intervention site being slightly larger.
CONCLUSIONS


The integrated WASH, MNCH, nutrition and ECD interventions resulted in notable decline in all-cause diarrhoea and improvements in water quality in the rural resource-limited population in Kenya. This indicates a direct public health impact of the interventions and provides early evidence for public health policy makers to support the sustained implementation of these interventions.",2022,"Besides rotavirus and pathogenic Escherichia coli, the rate of isolation of other diarrhoea-causing bacteria declined substantially in the intervention site.","['Kenya', 'in a resource-constrained rural setting in Kenya']","['Integrated Water, Sanitation, Hygiene, Health and Nutritional Interventions', 'integrated WASH, MNCH, nutrition and ECD interventions']","['Diarrhoea Disease Epidemiology and Microbial Quality of Water', 'rate of isolation of other diarrhoea-causing bacteria', 'microbial quality of community and household water', 'impact of Water, Hygiene and Sanitation (WASH), Maternal, New-born and Child Health (MNCH), nutrition and Early Childhood Development (ECD) on diarrhoea and microbial quality of water', 'water quality']","[{'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C1547959', 'cui_str': 'Wash'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}]",,0.0926291,"Besides rotavirus and pathogenic Escherichia coli, the rate of isolation of other diarrhoea-causing bacteria declined substantially in the intervention site.","[{'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Apondi Wandera', 'Affiliation': 'Institute of Tropical Medicine, Nagasaki University-Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Muriithi', 'Affiliation': 'Institute of Tropical Medicine, Nagasaki University-Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Kathiiko', 'Affiliation': 'Institute of Tropical Medicine, Nagasaki University-Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mutunga', 'Affiliation': 'Institute of Tropical Medicine, Nagasaki University-Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Wachira', 'Affiliation': 'Institute of Tropical Medicine, Nagasaki University-Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Maurine', 'Initials': 'M', 'LastName': 'Mumo', 'Affiliation': 'Institute of Tropical Medicine, Nagasaki University-Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mwangi', 'Affiliation': 'Department of Health & Nutrition, World Vision Kenya, Nairobi, Kenya.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tinkoi', 'Affiliation': 'Department of Health & Nutrition, World Vision Kenya, Nairobi, Kenya.'}, {'ForeName': 'Mirasine', 'Initials': 'M', 'LastName': 'Meiguran', 'Affiliation': 'Department of Health & Nutrition, World Vision Kenya, Nairobi, Kenya.'}, {'ForeName': 'Pius', 'Initials': 'P', 'LastName': 'Akumu', 'Affiliation': 'Department of Health & Nutrition, World Vision Kenya, Nairobi, Kenya.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Ndege', 'Affiliation': 'Department of Health & Nutrition, World Vision Kenya, Nairobi, Kenya.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Kasiku', 'Affiliation': 'Department of Health & Nutrition, World Vision Kenya, Nairobi, Kenya.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""Ang'awa"", 'Affiliation': 'Department of Health & Nutrition, World Vision Kenya, Nairobi, Kenya.'}, {'ForeName': 'Ryoichiro', 'Initials': 'R', 'LastName': 'Mozichuki', 'Affiliation': 'Africa Region, World Vision Japan, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Institute of Tropical Medicine, Nagasaki University-Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Morita', 'Affiliation': 'Institute of Tropical Medicine, Nagasaki University-Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Ouma', 'Affiliation': 'Department of Biomedical Sciences and Technology, Maseno University, Maseno, Kenya.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Ichinose', 'Affiliation': 'Institute of Tropical Medicine, Nagasaki University-Kenya Medical Research Institute, Nairobi, Kenya.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13793']
1925,35700142,Design of the COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using an UACR Endpoint study (CONFIDENCE).,"BACKGROUND


Despite available interventions, people with type 2 diabetes (T2D) remain at risk of chronic kidney disease (CKD). Finerenone, a potent and selective nonsteroidal mineralocorticoid receptor antagonist, and sodium-glucose co-transporter 2 inhibitors (SGLT2is) can reduce both kidney and cardiovascular risks in people with CKD and T2D. Here we outline the design of a study to investigate whether dual therapy with finerenone and a SGLT2i is superior to either agent alone.
METHODS


CONFIDENCE (NCT05254002) is a randomized, controlled, double-blind, double-dummy, international, multicentre, three-armed, parallel-group, 7.5-8.5-month, Phase 2 study in approximately 807 adults with T2D, stage 2-3 CKD and a urine albumin-to-creatinine ratio (UACR) from ≥ 300-<5000 mg/g. The primary objective is to demonstrate that 6 months' dual therapy comprising finerenone and the SGLT2i empagliflozin is superior for reducing albuminuria versus either agent alone. Interventions will be once-daily finerenone 10 mg or 20 mg (target dose) plus empagliflozin 10 mg, or empagliflozin 10 mg alone, or finerenone 10 mg or 20 mg (target dose) alone.
RESULTS


The primary outcome is relative change from baseline in UACR among the three groups. Secondary outcomes will further characterize efficacy and safety, including change in eGFR and incident hyperkalaemia.
CONCLUSIONS


CONFIDENCE is evaluating the safety, tolerability and efficacy of dual use of finerenone and a SGLT2i in adults with CKD and T2D. Should an additive effect be shown, early and efficient intervention with dual finerenone and SGLT2i therapy could slow disease progression and provide long-term benefits for people with CKD and T2D.",2022,"CONCLUSIONS


CONFIDENCE is evaluating the safety, tolerability and efficacy of dual use of finerenone and a SGLT2i in adults with CKD and T2D. Should an additive effect be shown, early and efficient intervention with dual finerenone and SGLT2i therapy could slow disease progression and provide long-term benefits for people with CKD and T2D.","['people with type 2 diabetes (T2D) remain at risk of chronic kidney disease (CKD', 'adults with CKD and T2D', 'participants with chronic kidney disease and type 2 diabetes using an UACR Endpoint study (CONFIDENCE', 'people with CKD and T2D', 'parallel-group, 7.5-8.5-month, Phase 2 study in approximately 807 adults with T2D, stage 2-3 CKD and a urine albumin-to-creatinine ratio (UACR) from\xa0≥']","['sodium-glucose co-transporter 2 inhibitors (SGLT2is', 'finerenone and a SGLT2i', 'SGLT2i empagliflozin', 'Finerenone', 'FInerenone anD EmpaglifloziN', 'empagliflozin 10\xa0mg, or empagliflozin 10\xa0mg alone, or finerenone 10\xa0mg or 20\xa0mg (target dose) alone']","['relative change from baseline in UACR', 'safety, tolerability and efficacy', 'efficacy and safety, including change in eGFR and incident hyperkalaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3697935', 'cui_str': 'At risk of chronic kidney disease'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C4045511', 'cui_str': 'finerenone'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}]",807.0,0.297116,"CONCLUSIONS


CONFIDENCE is evaluating the safety, tolerability and efficacy of dual use of finerenone and a SGLT2i in adults with CKD and T2D. Should an additive effect be shown, early and efficient intervention with dual finerenone and SGLT2i therapy could slow disease progression and provide long-term benefits for people with CKD and T2D.","[{'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Green', 'Affiliation': 'Duke University School of Medicine and Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Mottl', 'Affiliation': 'University of North Carolina Kidney Center, UNC School of Medicine; Division, Chapel Hill, NC, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Centre, Munich, Germany, and Friedrich Alexander University, Erlangen, Germany.'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipid Research, Washington University in St. Louis, School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Centre Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'Data Science and Analytics, Bayer PLC, Reading, UK.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gay', 'Affiliation': 'Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfac198']
1926,35700246,Wearable-Based Assessment of Frailty Trajectories During Cardiac Rehabilitation After Open-Heart Surgery.,"Frailty in patients after open-heart surgery influences the type and intensity of a cardiac rehabilitation program. The response to tailored exercise training can be different, requiring convenient tools to assess the effectiveness of a training program routinely. The study aims to investigate whether kinematic measures extracted from the acceleration signals can provide information about frailty trajectories during rehabilitation. One hundred patients after open-heart surgery, assigned to the equal-sized intervention and control groups, participated in exercise training during inpatient rehabilitation. After rehabilitation, the intervention group continued exercise training at home, whereas the control group was asked to maintain the usual physical activity regimen. Stride time, cadence, movement vigor, gait asymmetry, Lissajous index, and postural sway were estimated during the clinical walk and stair-climbing tests before and after inpatient rehabilitation as well as after home-based exercise training. Frailty was assessed using the Edmonton frail scale. Most kinematic measures estimated during walking improved after rehabilitation along with the improvement in frailty status, i.e., stride time, cadence, postural sway, and movement vigor improved in 71%, 77%, 81%, and 83% of patients, respectively. Meanwhile, kinematic measures during stair-climbing improved to a lesser extent compared to walking. Home-based exercise training did not result in a notable change in kinematic measures which agrees well with only a negligible deterioration in frailty status. The study demonstrates the feasibility to follow frailty trajectories during inpatient rehabilitation after open-heart surgery based on kinematic measures extracted using a single wearable sensor.",2022,Home-based exercise training did not result in a notable change in kinematic measures which agrees well with only a negligible deterioration in frailty status.,['One hundred patients after open-heart surgery'],"['Home-based exercise training', 'Cardiac Rehabilitation', 'equal-sized intervention and control groups, participated in exercise training', 'tailored exercise training', 'exercise training']","['Frailty Trajectories', 'stride time, cadence, postural sway, and movement vigor', 'Stride time, cadence, movement vigor, gait asymmetry, Lissajous index, and postural sway were estimated during the clinical walk and stair-climbing tests']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0430519', 'cui_str': 'Stair-climbing test'}]",100.0,0.00304922,Home-based exercise training did not result in a notable change in kinematic measures which agrees well with only a negligible deterioration in frailty status.,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Butkuviene', 'Affiliation': ''}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Tamuleviciute-Prasciene', 'Affiliation': ''}, {'ForeName': 'Aurelija', 'Initials': 'A', 'LastName': 'Beigiene', 'Affiliation': ''}, {'ForeName': 'Vitalija', 'Initials': 'V', 'LastName': 'Barasaite', 'Affiliation': ''}, {'ForeName': 'Daivaras', 'Initials': 'D', 'LastName': 'Sokas', 'Affiliation': ''}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': ''}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Petrenas', 'Affiliation': ''}]",IEEE journal of biomedical and health informatics,['10.1109/JBHI.2022.3181738']
1927,35700539,"Efficacy of two low-level laser therapy protocols following lower third molar surgery - a randomized, double-blind, controlled clinical trial.","The aim of this study was to test two low-level laser therapy protocols by evaluating pain control, swelling and trismus in the postoperative period of lower third molar surgeries. This was a randomized, double-blind, placebo-controlled, crossover trial. Patients presenting two symmetrically impacted mandibular third molars were included. One side was randomly assigned for LLLT applied immediately after surgery (T1) and then after 24 (T2) and 48 hours (T3) (Protocol A). The other side received LLLT applied immediately after surgery and placebo after 24 and 48 hours (Protocol B). LLLT was given by intraoral application (660nm, 5 J/cm2, 10 s, 20 mW, 4 points) followed by extraoral application (789 nm, 30 J/cm2, 20 s, 60 mW, 8 points). The placebo application was similar to that of the experimental side but with laser simulation. The primary outcomes were pain control, swelling and trismus intensity at T1, T2, T3 and 7 days after surgery (T4). Data were analyzedbyANOVArepeated measures and Wilcoxon test (p<.05). The final sample consisted of 21 patients (42 teeth). There were no statistical differences for pain level between protocols A and B over time (p= .909), although the amount of analgesic medication was lower with protocol A at T2 (p=.022). There were no differences in swelling (p=.958) or trismus (p=.837) between the protocols used over time. Both protocols performed similarly for pain control, swelling and trismus. Therefore, for practical reasons, a single laser application in the immediate postoperative period could be indicated for the management of postoperative discomfort in lower third molar surgery.",2022,There were no differences in swelling (p=.958) or trismus (p=.837) between the protocols used over time.,"['21 patients (42 teeth', 'lower third molar surgery ', 'lower third molar surgeries', 'Patients presenting two symmetrically impacted mandibular third molars were included']","['low-level laser therapy protocols', 'placebo', 'LLLT', 'extraoral application']","['analgesic medication', 'Efficacy', 'pain control, swelling and trismus', 'pain level', 'swelling (p=.958) or trismus', 'pain control, swelling and trismus intensity at T1, T2, T3 and 7 days after surgery (T4']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442089', 'cui_str': 'Extraoral approach'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.534673,There were no differences in swelling (p=.958) or trismus (p=.837) between the protocols used over time.,"[{'ForeName': 'Geovane M', 'Initials': 'GM', 'LastName': 'Ferreira', 'Affiliation': 'Universidade Federal de Goiás, Faculdade de Odontologia, Departamento de Estomatologia, Goiânia, Brasil.'}, {'ForeName': 'Lucianna F', 'Initials': 'LF', 'LastName': 'Prado', 'Affiliation': 'Universidade Paulista, Faculdade de Odontologia, Departamento de Cirurgia, Goiânia, Brasil.'}, {'ForeName': 'Kleber Vr', 'Initials': 'KV', 'LastName': 'Santos', 'Affiliation': 'Universidade Federal de Goiás, Faculdade de Odontologia, Departamento de Estomatologia, Goiânia, Brasil.'}, {'ForeName': 'Lívia G', 'Initials': 'LG', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Federal de Goiás, Faculdade de Odontologia, Departamento de Estomatologia, Goiânia, Brasil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Valladares-Neto', 'Affiliation': 'Universidade Federal de Goiás, Faculdade de Odontologia, Departamento de Reabilitação Oral, Goiânia, Brasil.'}, {'ForeName': 'Érica M', 'Initials': 'ÉM', 'LastName': 'Torres', 'Affiliation': 'Universidade Federal de Goiás, Faculdade de Odontologia, Departamento de Reabilitação Oral, Goiânia, Brasil.'}, {'ForeName': 'Maria Ag', 'Initials': 'MA', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal de Goiás, Faculdade de Odontologia, Departamento de Estomatologia, Goiânia, Brasil. mariaagsilva@gmail.com.'}]",Acta odontologica latinoamericana : AOL,['10.54589/aol.35/1/31']
1928,35700523,Do Prostaglandin Analogue Lash Lengtheners Cause Eyelid Fat and Volume Loss?,"BACKGROUND


Prostaglandin analogues (PGAs; a first-line anti-glaucoma treatment) have been re-marketed as popular eyelash lengthening serums due to their lash lengthening and thickening side-effects. Periorbital volume loss is now a well-established side-effect of topical PGAs used to treated glaucoma (prostaglandin-associated periorbitopathy [PAP]) but has not, to date, been listed as a potential side-effect of lash lengthening serums containing PGA.
OBJECTIVES


To identify whether periorbital fat/volume loss is seen in users of prostaglandin analogue lash lengtheners.
METHODS


A case report and informal randomised controlled study comparing ""before-and-after"" colour photos displayed on the websites of PGA-containing lash lengtheners (PGALL) (i.e., containing bimatoprost, norbimatoprost, isopropyl cloprostenate, dechloro-dihydroxy-difluoro-ethylcloprostenolamide, or methylamido-dihydro-noralfaprostal), compared with two control groups: non-PGALL (NPGALL); false eyelashes (FL). Expert and layperson blinded graders used a purpose-designed grading system to identify subtle signs of periorbital fat/volume loss over time.
RESULTS


A 35-year-old female developed thin, wrinkled, darker skin and periorbital hollowing within 10-months of using Lash Boost (Rodan & Fields, San Francisco, CA), containing isopropyl cloprostenate, which reversed six months after discontinuation. Fifteen ""before-and-after"" image pairs (PGALL, n=10; NPGALL, n=3; FL, n=2) were graded by five graders (three expert, two layperson). Mean grading score was 8.2 (of 19) in the PGALL group: NPGALL, 2.3; FL, 3.2. PGALL scores were significantly higher than NPGALL (p<0.001) and FL (p=0.017) groups.
CONCLUSIONS


Review of commercial ""before-and-after"" photos suggests PGALL users develop changes compatible with PAP. Consumers must be aware of the possibility of periorbital volume loss prior to commencing PGALLs. Often the customer-facing product ingredient list contains no mention of PGA.",2022,"PGALL scores were significantly higher than NPGALL (p<0.001) and FL (p=0.017) groups.
",[],['before-and-after'],"['PGALL scores', 'Mean grading score']",[],[],"[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",2.0,0.0558018,"PGALL scores were significantly higher than NPGALL (p<0.001) and FL (p=0.017) groups.
","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Jamison', 'Affiliation': 'Corneoplastic Unit, Queen Victoria Hospital NHS Foundation Trust, East Grinstead, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Okafor', 'Affiliation': 'Corneoplastic Unit, Queen Victoria Hospital NHS Foundation Trust, East Grinstead, UK.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Ullrich', 'Affiliation': 'Corneoplastic Unit, Queen Victoria Hospital NHS Foundation Trust, East Grinstead, UK.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Schiedler', 'Affiliation': 'Private practice, Ashland, OR, USA.'}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Corneoplastic Unit, Queen Victoria Hospital NHS Foundation Trust, East Grinstead, UK.'}]",Aesthetic surgery journal,['10.1093/asj/sjac156']
1929,35700443,"Correction to: Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus.",,2022,,['patients with moderate-to-severe active systemic lupus erythematosus'],"['dapirolizumab pegol', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C4548277', 'cui_str': 'dapirolizumab pegol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.409659,,[],"Rheumatology (Oxford, England)",['10.1093/rheumatology/keac326']
1930,35700440,Complications of orthopedic treatment in patients diagnosed with X-linked hypophosphatemic rickets.,"OBJECTIVES


XLHR in children with a Rickets Severity Score ≥2 can now be treated with the new antibody drug, Burosumab, which prevents bone deformities and increases gait endurance. This study illustrates the extent of complications in the traditional orthopedic treatment of XLHR. The impact of surgery and severity of complications in this patient population has not been systematically assessed before.
METHODS


The search strategy resulted in 215 studies and data were collected from 19 eligible studies and complications were categorized. Four medical charts of patients with XLHR at Aalborg University Hospital were assessed.
RESULTS


One complication occurred on average per surgical procedure for XLHR in the published literature. The 168 reported complications were categorized as follows: Type I (n=79): Complications with minimal intervention required and treatment goal still achieved, Type II (n=41): Complications with substantial change in treatment plan and treatment goal still achieved, Type IIIA (n=23): Complications with failure to achieve treatment goal and no new pathology or permanent sequelae, Type IIIB (n=25): Complications with failure to achieve treatment goal and/or new pathology or permanent sequelae.
CONCLUSIONS


In average, one complication occurred per surgery and the severity of complications were substantial. The treatment goal was not achieved in 28% of surgeries whereof half of them resulted in permanent sequalae or new pathology. Our findings support the use of Burosumab for treatment of the skeletal changes in XLHR as the reported side-effects in Burosumab treatment appear negligible compared to the impact of surgeries and related complications (Imel EA, Glorieux FH, Whyte MP, Munns CF, Ward LM, Nilsson O, et al. Burosumab versus conventional therapy in children with X-linked hypophosphataemia: a randomised, active-controlled, open-label, phase 3 trial. Lancet 2019;393:2416-27). However, orthopedic surgery might still be needed for correcting deformities restricting activities of daily living in XLHR patients.",2022,The treatment goal was not achieved in 28% of surgeries whereof half of them resulted in permanent sequalae or new pathology.,"['Four medical charts of patients with XLHR at Aalborg University Hospital were assessed', 'children with a Rickets Severity Score\xa0≥2', 'Type IIIA (n=23', 'children with X-linked hypophosphataemia', 'patients diagnosed with X-linked hypophosphatemic rickets', 'Type I (n=79): Complications with minimal intervention required and treatment goal still achieved, Type II (n=41', 'Type IIIB (n=25']",['Burosumab versus conventional therapy'],['permanent sequalae or new pathology'],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0733682', 'cui_str': 'Hypophosphatemic Rickets, X-Linked Dominant'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3540852', 'cui_str': 'Hypophosphatemia, X-Linked'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3536984', 'cui_str': 'Familial x-linked hypophosphatemic vitamin D refractory rickets'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C4301607', 'cui_str': 'burosumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",,0.0577003,The treatment goal was not achieved in 28% of surgeries whereof half of them resulted in permanent sequalae or new pathology.,"[{'ForeName': 'Carl Gustaf', 'Initials': 'CG', 'LastName': 'Paludan', 'Affiliation': 'Department of Orthopaedics, Interdisciplinary Orthopedics, Aalborg University Hospital, Hobrovej 18-22, 9000 Aalborg, Nordjylland, Denmark.'}, {'ForeName': 'Kristoffer Koed Vittrup', 'Initials': 'KKV', 'LastName': 'Thomsen', 'Affiliation': 'Department of Orthopaedics, Interdisciplinary Orthopedics, Aalborg University Hospital, Hobrovej 18-22, 9000 Aalborg, Nordjylland, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Rahbek', 'Affiliation': 'Department of Orthopaedics, Interdisciplinary Orthopedics, Aalborg University Hospital, Hobrovej 18-22, 9000 Aalborg, Nordjylland, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Kold', 'Affiliation': 'Department of Orthopaedics, Interdisciplinary Orthopedics, Aalborg University Hospital, Hobrovej 18-22, 9000 Aalborg, Nordjylland, Denmark.'}]",Journal of pediatric endocrinology & metabolism : JPEM,['10.1515/jpem-2021-0775']
1931,35704218,"Efficacy of Oral vs. Intravenous Calcium Supplementation for Continuation Therapy in Hypocalcemic Seizures: A Randomized, Controlled Trial.","OBJECTIVE


To evaluate efficacy of oral vs. intravenous calcium supplementation for continuation therapy in hypocalcemic seizures.
METHODS


Sixty children between 1 mo and 5 y presenting with hypocalcemic seizures without any other underlying febrile, chronic systemic disease, or acute neurological illness were included. Participants were randomized to receive either intravenous (IV) 10% calcium gluconate (n = 30) or oral elemental calcium (n = 30) for 48 h following initial seizure control with intravenous calcium.
RESULTS


Seizures recurred in 3 (10%) children in IV group as compared to 4 (13.3%) in oral calcium group (p = 0.278) within 48 h. Serum calcium levels achieved in the two treatment groups at 24 h [7.96 (1.32) vs. 8.23 (1.58) mg/dL; p = 0.476] and 48 h [8.5 (1.01) vs. 8.63 (1.39) mg/dL; p = 0.681] were comparable.
CONCLUSION


Oral calcium may be as efficacious as intravenous calcium during continuation phase of treating hypocalcemic seizures; however, further studies are needed for definite recommendations.
TRIAL REGISTRATION


Trial Registration number: CTRI/2017/12/011042.",2022,"RESULTS


Seizures recurred in 3 (10%) children in IV group as compared to 4 (13.3%) in oral calcium group (p = 0.278) within 48 h.","['Hypocalcemic Seizures', 'Sixty children between 1 mo and', 'hypocalcemic seizures', '5 y presenting with hypocalcemic seizures without any other underlying febrile, chronic systemic disease, or acute neurological illness']","['Oral vs. Intravenous Calcium Supplementation', 'intravenous (IV) 10% calcium gluconate (n\u2009=\u200930) or oral elemental calcium', 'oral vs. intravenous calcium supplementation']",['Serum calcium levels'],"[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0006699', 'cui_str': 'Calcium Gluconate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}]",60.0,0.371256,"RESULTS


Seizures recurred in 3 (10%) children in IV group as compared to 4 (13.3%) in oral calcium group (p = 0.278) within 48 h.","[{'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Dhir', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, 110095, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, 110095, India.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, 110095, India.'}, {'ForeName': 'Prerna', 'Initials': 'P', 'LastName': 'Batra', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, 110095, India.'}, {'ForeName': 'Rafat S', 'Initials': 'RS', 'LastName': 'Ahmed', 'Affiliation': 'Department of Biochemistry, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.'}, {'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, 110095, India. prof.piyush.gupta@gmail.com.'}]",Indian journal of pediatrics,['10.1007/s12098-022-04178-0']
1932,35704124,Real-time Feedback to Improve HIV Treatment Adherence in Pregnant and Postpartum Women in Uganda: A Randomized Controlled Trial.,"We assessed an intervention aimed at improving adherence to antiretroviral therapy (ART) among pregnant and postpartum women living with HIV (PPWLH). We randomized 133 pregnant women initiating ART in Uganda to receive text reminders generated by real time-enabled electronic monitors and data-informed counseling through 3 months postpartum (PPM3) or standard care. Intention-to-treat analyses found low adherence levels and no intervention impact. Proportions achieving ≥95% adherence in PPM3 were 16.4% vs. 9.1% (t = -1.14, p = 0.26) in intervention vs. comparison groups, respectively; 30.9% vs. 29.1% achieved ≥80% adherence. Additional analyses found significant adherence declines after delivery, and no effect on disease progression (CD4-cell count, viral load), though treatment interruptions were significantly fewer in intervention participants. Per-protocol analyses encompassing participants who used adherence monitors as designed experienced better outcomes, suggesting potential benefit for some PPWLH. The study was registered on ClinicalTrials.Gov (NCT02396394).",2022,"Proportions achieving ≥95% adherence in PPM3 were 16.4% vs. 9.1% (t = -1.14, p = 0.26) in intervention vs. comparison groups, respectively; 30.9% vs. 29.1% achieved ≥80% adherence.","['133 pregnant women initiating ART in Uganda to receive', 'pregnant and postpartum women living with HIV (PPWLH', 'Pregnant and Postpartum Women in Uganda']","['text reminders generated by real time-enabled electronic monitors and data-informed counseling through 3 months postpartum (PPM3) or standard care', 'antiretroviral therapy (ART']","['disease progression (CD4-cell count, viral load', 'Proportions achieving ≥95% adherence in PPM3', 'HIV Treatment Adherence']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}]",133.0,0.351744,"Proportions achieving ≥95% adherence in PPM3 were 16.4% vs. 9.1% (t = -1.14, p = 0.26) in intervention vs. comparison groups, respectively; 30.9% vs. 29.1% achieved ≥80% adherence.","[{'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Sabin', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, 02118, Boston, MA, USA. lsabin@bu.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Simmons', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, 02118, Boston, MA, USA.'}, {'ForeName': 'Nafisa', 'Initials': 'N', 'LastName': 'Halim', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, 02118, Boston, MA, USA.'}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, 02118, Boston, MA, USA.'}, {'ForeName': 'Allen L', 'Initials': 'AL', 'LastName': 'Gifford', 'Affiliation': 'Department of Medicine, Boston University School of Medicine, 02118, Boston, MA, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'West', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, 02118, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Larson', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, 02118, Boston, MA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Bonawitz', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, 02118, Boston, MA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aroda', 'Affiliation': 'Mildmay Uganda, Kampala Road, Kampala, Uganda.'}, {'ForeName': 'Bolanle', 'Initials': 'B', 'LastName': 'Banigbe', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, 02118, Boston, MA, USA.'}, {'ForeName': 'Alayna J', 'Initials': 'AJ', 'LastName': 'Holderman', 'Affiliation': 'Department of Human Genetics, University of Pittsburgh School of Public Health, 15261, Pittsburgh, PA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Department of Epidemiology & Biostatistics, Boston University School of Public Health, 02118, Boston, MA, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'DeSilva', 'Affiliation': 'Center for Excellence in Public Health, University of New England, 04103, Portland, ME, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gasuza', 'Affiliation': 'Mildmay Uganda, Kampala Road, Kampala, Uganda.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mukasa', 'Affiliation': 'Mildmay Uganda, Kampala Road, Kampala, Uganda.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Messersmith', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, 02118, Boston, MA, USA.'}]",AIDS and behavior,['10.1007/s10461-022-03712-7']
1933,35704122,Comparison between 6-week foam rolling intervention program with and without vibration on rolling and non-rolling sides.,"PURPOSE


The chronic effects of unilateral foam rolling (FR) or FR with vibration (VFR) intervention on the rolling and non-rolling sides (cross-education effects) are still unclear. Thus, this study aimed to investigate the effects of unilateral 6-week FR or VFR intervention on ankle dorsiflexion range of motion (DF ROM), muscle stiffness, and muscle strength in both rolling and non-rolling sides.
METHODS


Thirty healthy young men were randomly allocated into the FR (n = 15) or the VFR intervention group (n = 15). Participants performed three sets of unilateral FR or VFR interventions for 60 s of the calf muscles twice/week, for 6 weeks. DF ROM, gastrocnemius muscle stiffness, and maximal voluntary isometric contraction (MVIC) torque were assessed in the rolling and non-rolling sides before and after the intervention.
RESULTS


The DF ROM increased significantly (p < 0.05) to the same extent in the FR and VFR intervention groups on both rolling (FR: d = 0.58, VFR: d = 0.63) and non-rolling (FR: d = 0.39, VFR: d = 0.50) sides. Similarly, the passive torque at DF ROM increased significantly (p < 0.05) to the same extent in the FR and VFR intervention groups on both rolling (FR: d = 0.85, VFR: d = 0.77) and non-rolling (FR: d = 0.76, VFR: d = 0.68) sides. However, there were no significant changes in muscle stiffness and MVIC after FR and VFR interventions on both the rolling and non-rolling sides. FR and VFR interventions could increase the ROM in both the rolling and non-rolling sides but could not change muscle stiffness and strength.
CONCLUSIONS


The results showed that it is not necessarily needed to perform VFR to increase ROM in the long term.",2022,"FR and VFR interventions could increase the ROM in both the rolling and non-rolling sides but could not change muscle stiffness and strength.
",['Thirty healthy young men'],"['VFR intervention', 'non-rolling (FR', 'unilateral foam rolling (FR) or FR with vibration (VFR) intervention', 'FR', 'FR and VFR interventions', 'VFR', 'unilateral 6-week FR or VFR intervention', 'unilateral FR or VFR interventions']","['ankle dorsiflexion range of motion (DF ROM), muscle stiffness, and muscle strength', 'DF ROM', 'ROM', 'passive torque at DF ROM', 'muscle stiffness and MVIC', 'DF ROM, gastrocnemius muscle stiffness, and maximal voluntary isometric contraction (MVIC) torque']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",30.0,0.035639,"FR and VFR interventions could increase the ROM in both the rolling and non-rolling sides but could not change muscle stiffness and strength.
","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Kasahara', 'Affiliation': 'Department of Physical Therapy, Faculty of Rehabilitation, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, 950-3198, Japan.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Konrad', 'Affiliation': 'Institute of Human Movement Science, Sport and Health, Graz University, Mozartgasse 14, 8010, Graz, Austria.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Yoshida', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, 950-3198, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Murakami', 'Affiliation': 'Department of Physical Therapy, Faculty of Rehabilitation, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, 950-3198, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, 950-3198, Japan.'}, {'ForeName': 'Kodai', 'Initials': 'K', 'LastName': 'Aizawa', 'Affiliation': 'Department of Physical Therapy, Faculty of Rehabilitation, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, 950-3198, Japan.'}, {'ForeName': 'Ryoma', 'Initials': 'R', 'LastName': 'Koizumi', 'Affiliation': 'Department of Physical Therapy, Faculty of Rehabilitation, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, 950-3198, Japan.'}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Sport and Exercise Sciences Research Unit, Department of Psychology, Educational Science and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Faculty of Rehabilitation Sciences, Nishi Kyushu University, 4490-9 Ozaki, Kanzaki, Saga, 842-8585, Japan. nakamuramas@nisikyu-u.ac.jp.'}]",European journal of applied physiology,['10.1007/s00421-022-04975-7']
1934,35704106,Prospective randomized controlled trial comparing fulguration versus fulguration and hydrodistension for Hunner-type interstitial cystitis/bladder pain syndrome.,"PURPOSE


In Hunner-type interstitial cystitis/bladder pain syndrome (IC/BPS), it is unclear whether suburothelial afferents underlying normal-appearing background areas contribute to symptom development. We examined whether adding hydrodistension (HD) to transurethral fulguration (TUF) of Hunner lesions, for the purpose of treating the background areas, is superior to TUF alone.
METHODS


This randomized controlled trial included 52 patients with Hunner-type IC/BPS allocated at a 1:1 (TUF:TUF+HD) ratio. HD was performed at 80 cmH 2 O for 8 min before TUF in the TUF+HD group. Thirty-three patients remained until the end of the 6-month observational period. The primary endpoint was the visual analogue scale (VAS) pain score at 1 month. Major secondary endpoints were the treatment-failure rate, VAS pain scores at ≥ 2 months, and frequency-volume chart parameters.
RESULTS


Both TUF and TUF+HD showed significant improvement in VAS pain score at 1 month (95% confidence interval [CI]: - 1.62 to 0.16, P = 0.106). VAS pain scores were significantly lower in TUF+HD than TUF at 2 (95% CI: - 1.97 to - 0.28, P = 0.011), 4 (95% CI: - 2.83 to - 0.72, P = 0.002), and 6 (95% CI: - 3.11 to - 0.07, P = 0.040) months. Treatment-failure rate was higher in TUF (36.4%) than TUF+HD (17.4%), without significance (odds ratio: 2.714, 95% CI: 0.68 to 10.84, P = 0.189). Functional capacity and urgency were not significantly different between groups.
CONCLUSION


The addition of HD to TUF tended to be superior to TUF monotherapy for controlling pain in Hunner-type IC/BPS. This indicates that not only Hunner lesions but also normal-appearing background areas may have a role in the pain of IC/BPS.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03987594, date of registration: 2019-06-17 (retrospectively registered).",2022,"Both TUF and TUF+HD showed significant improvement in VAS pain score at 1 month (95% confidence interval [CI]: - 1.62 to 0.16, P = 0.106).","['Hunner-type interstitial cystitis/bladder pain syndrome', 'registration: 2019-06-17 (retrospectively registered', 'Hunner-type interstitial cystitis/bladder pain syndrome (IC/BPS', '52 patients with Hunner-type IC/BPS allocated at a 1:1 (TUF:TUF+HD) ratio']","['fulguration versus fulguration and hydrodistension', 'TUF and TUF+HD', 'adding hydrodistension (HD) to transurethral fulguration (TUF', 'TUF monotherapy']","['Functional capacity and urgency', 'VAS pain scores', 'treatment-failure rate, VAS pain scores at\u2009≥\u20092\xa0months, and frequency-volume chart parameters', 'Treatment-failure rate', 'VAS pain score', 'visual analogue scale (VAS) pain score']","[{'cui': 'C0268824', 'cui_str': 'Chronic ulcerating interstitial cystitis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",52.0,0.149035,"Both TUF and TUF+HD showed significant improvement in VAS pain score at 1 month (95% confidence interval [CI]: - 1.62 to 0.16, P = 0.106).","[{'ForeName': 'Hee Seo', 'Initials': 'HS', 'LastName': 'Son', 'Affiliation': 'Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Severance Hospital, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Urology, Ewha Womans University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jang Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Severance Hospital, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea. JKIM@yuhs.ac.'}]",World journal of urology,['10.1007/s00345-022-04062-8']
1935,35704092,The use of single-stapling techniques reduces anastomotic complications in minimal-invasive rectal surgery.,"BACKGROUND


Leakage of rectal anastomoses is one of the most important and feared complications in colorectal surgery. Apart from patient-specific risk factors, technical aspects may influence the occurrence of anastomotic complications. This study investigated whether using single-stapling techniques (SST) instead of the double-stapling technique (DST) for minimal-invasive rectal anastomosis is associated with a lower rate of anastomotic complications.
METHODS


A retrospective review of 272 patients who received a minimally invasive stapled rectal anastomosis (3-16 cm from the anal verge) at our institution from 2015 to 2020 was performed. In 131 patients, rectal anastomosis was created by SST (SST group), while 141 patients received a rectal anastomosis with crossing stapler lines (DST group). The impact of the anastomotic technique on patient outcomes was determined by uni- and multivariate analyses.
RESULTS


Overall anastomotic leakage rate was 6%. Patients with SST anastomoses had a lower leakage rate than patients with DST anastomoses (3% vs. 9% in the DST group, p = 0.045). The rate of anastomotic stenosis was lower in the SST group than in the DST group (1% vs. 6%, p = 0.037). Overall morbidity and mortality did not differ between the two groups. Multivariate analysis showed that single-stapling techniques significantly reduce the risk of anastomotic leakage (OR 3.5 [1.0-11.5], p = 0.043).
CONCLUSION


The use of SST for rectal anastomosis may help to reduce anastomotic complications. This finding should be confirmed by a randomized controlled trial.",2022,Overall morbidity and mortality did not differ between the two groups.,"['3-16\xa0cm from the anal verge) at our institution from 2015 to 2020 was performed', '272 patients who received a', '131 patients, rectal anastomosis was created by', 'minimal-invasive rectal surgery']","['single-stapling techniques', 'SST', 'DST', 'double-stapling technique (DST', 'minimally invasive stapled rectal anastomosis', 'single-stapling techniques (SST', 'SST (SST', 'rectal anastomosis with crossing stapler lines (DST']","['Overall anastomotic leakage rate', 'risk of anastomotic leakage', 'rate of anastomotic stenosis', 'Overall morbidity and mortality', 'leakage rate', 'anastomotic complications']","[{'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0193171', 'cui_str': 'Anastomosis of rectum'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0185012', 'cui_str': 'Closure by staple'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0193171', 'cui_str': 'Anastomosis of rectum'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C1141928', 'cui_str': 'Anastomotic complication'}]",,0.246146,Overall morbidity and mortality did not differ between the two groups.,"[{'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Brunner', 'Affiliation': 'Department of General and Visceral Surgery, Friedrich-Alexander-University, Krankenhausstraße 12, Erlangen, 91054, Germany. Maximilian.Brunner@uk-erlangen.de.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': ""Zu'bi"", 'Affiliation': 'Department of General and Visceral Surgery, Friedrich-Alexander-University, Krankenhausstraße 12, Erlangen, 91054, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': 'Department of General and Visceral Surgery, Friedrich-Alexander-University, Krankenhausstraße 12, Erlangen, 91054, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Denz', 'Affiliation': 'Department of General and Visceral Surgery, Friedrich-Alexander-University, Krankenhausstraße 12, Erlangen, 91054, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Langheinrich', 'Affiliation': 'Department of General, Thoracic and Vascular Surgery, Greifswald University, Ferdinand-Sauerbruch-Straße, VisceralGreifswald, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kersting', 'Affiliation': 'Department of General, Thoracic and Vascular Surgery, Greifswald University, Ferdinand-Sauerbruch-Straße, VisceralGreifswald, Germany.'}, {'ForeName': 'Georg F', 'Initials': 'GF', 'LastName': 'Weber', 'Affiliation': 'Department of General and Visceral Surgery, Friedrich-Alexander-University, Krankenhausstraße 12, Erlangen, 91054, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Department of General and Visceral Surgery, Friedrich-Alexander-University, Krankenhausstraße 12, Erlangen, 91054, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Krautz', 'Affiliation': 'Department of General and Visceral Surgery, Friedrich-Alexander-University, Krankenhausstraße 12, Erlangen, 91054, Germany. Christian.Krautz@uk-erlangen.de.'}]",International journal of colorectal disease,['10.1007/s00384-022-04197-5']
1936,35704507,The Effectiveness of A Slow-Paced Diaphragmatic Breathing Exercise in Children's Daily Life: A Micro-Randomized Trial.,"OBJECTIVE


Breathing exercises have been proposed as an effective intervention to improve subjective well-being and manage anxiety symptoms. As they are comparatively easy to learn and to implement, breathing exercises may be particularly beneficial for children. Although breathing exercises are ultimately supposed to provide salutary effects in individuals' everyday lives, immediate effects of breathing exercises in naturalistic contexts have received limited empirical attention. The purpose of this study was to examine immediate effects of slow-paced diaphragmatic breathing on negative affect as well as on relaxation in an ecologically valid setting. To that end, we conducted a micro-randomized trial in children's daily life.
METHOD


On each of 15 days, children ( N  = 171, aged 9-13 years, 54% female) were randomized to different conditions: performing a video-guided slow-paced diaphragmatic breathing exercise (experimental condition), watching a different video (active control condition), or a passive control condition.
RESULTS


The breathing exercise had no immediate effects on negative affect or relaxation compared to both control conditions. However, in situations when children reported higher levels of worries than usual, relaxation was higher when children performed the breathing exercise compared to the passive control condition. Compared to the active control condition, the breathing exercise did not result in higher levels of relaxation in situations when children worried more than normally.
CONCLUSIONS


Findings highlight that context-specific factors can modulate the effectiveness of breathing exercises and should be taken into account to tailor interventions to individuals' needs.",2022,"Compared to the active control condition, the breathing exercise did not result in higher levels of relaxation in situations when children worried more than normally.
","[""children's daily life"", ""Children's Daily Life"", '15\xa0days, children ( N  = 171, aged 9-13\xa0years, 54% female']","['slow-paced diaphragmatic breathing', 'Slow-Paced Diaphragmatic Breathing Exercise', 'breathing exercise', 'video-guided slow-paced diaphragmatic breathing exercise (experimental condition), watching a different video (active control condition), or a passive control condition']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0080574,"Compared to the active control condition, the breathing exercise did not result in higher levels of relaxation in situations when children worried more than normally.
","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Kramer', 'Affiliation': 'Department of Education and Human Development, DIPF | Leibniz Institute for Research and Information in Education.'}, {'ForeName': 'Andreas B', 'Initials': 'AB', 'LastName': 'Neubauer', 'Affiliation': 'Department of Education and Human Development, DIPF | Leibniz Institute for Research and Information in Education.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schmiedek', 'Affiliation': 'Department of Education and Human Development, DIPF | Leibniz Institute for Research and Information in Education.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2022.2084743']
1937,35699977,Patient Onboarding and Engagement to Build a Digital Study After Enrollment in a Clinical Trial (TAILOR-PCI Digital Study): Intervention Study.,"BACKGROUND


The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study is a novel proof-of-concept study that evaluated the feasibility of extending the TAILOR-PCI randomized controlled trial (RCT) follow-up period by using a remote digital platform.
OBJECTIVE


The aim of this study is to describe patients' onboarding, engagement, and results in a digital study after enrollment in an RCT.
METHODS


In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app. Those who did not respond to the letter were contacted by phone to survey the reasons for nonparticipation. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard patients, obtain consent, and administer activities in the digital study. The patients were asked to complete health-related surveys and digitally provide follow-up data. Our primary end points were the consent rate, the duration of participation, and the monthly activity completion rate in the digital study. The hypothesis being tested was formulated before data collection began.
RESULTS


After the parent trial was completed, letters were mailed to 907 eligible patients (representing 18.8% [907/4837] of total enrolled in the RCT) within 15.6 (SD 5.2) months of randomization across 24 sites. Among the 907 patients invited, 290 (32%) visited the study website and 110 (12.1%) consented-40.9% (45/110) after the letter, 33.6% (37/110) after the first phone call, and 25.5% (28/110) after the second call. Among the 47.4% (409/862) of patients who responded, 41.8% (171/409) declined to participate because of a lack of time, 31.2% (128/409) declined because of the lack of a smartphone, and 11.5% (47/409) declined because of difficulty understanding what was expected of them in the study. Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P<.001). A greater proportion had bachelor's degrees (47.2% vs 25.7%; P<.001) and were more computer literate (90.5% vs 62.3% of daily internet use; P<.001) than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9% (SD 7.6%); there was no decrease in this rate throughout the study duration.
CONCLUSIONS


Extended follow-up after enrollment in an RCT by using a digital study was technically feasible but was limited because of the inability to contact most eligible patients or a lack of time or access to a smartphone. Among the enrolled patients, most completed the required electronic visits. Enhanced recruitment methods, such as the introduction of a digital study at the time of RCT consent, smartphone provision, and robust study support for onboarding, should be explored further.
TRIAL REGISTRATION


Clinicaltrails.gov NCT01742117; https://clinicaltrials.gov/ct2/show/NCT01742117.",2022,Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P<.001).,"['previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app', '907 eligible patients (representing 18.8% [907/4837] of total enrolled in the RCT) within 15.6 (SD 5.2) months of randomization across 24 sites', '907 patients invited, 290 (32%) visited the study website and 110 (12.1%) consented-40.9% (45/110) after the letter, 33.6% (37/110) after the first phone call, and 25.5% (28/110) after the second call', 'Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P<.001']",[],"['Clopidogrel Response', 'consent rate, the duration of participation, and the monthly activity completion rate', 'computer literate', ""bachelor's degrees"", 'average completion rate']","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C4517822', 'cui_str': '6.4'}]",[],"[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",907.0,0.110205,Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P<.001).,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Avram', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'So', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Iturriaga', 'Affiliation': 'Department of Medicine, National Heart, Lung, and Blood Institute, Bethesda, MD, United States.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic Rochester, Rochester, MN, United States.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lennon', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic Rochester, Rochester, MN, United States.'}, {'ForeName': 'Vishakantha', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic Rochester, Rochester, MN, United States.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Geller', 'Affiliation': 'Department of Medicine, National Heart, Lung, and Blood Institute, Bethesda, MD, United States.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': ""Department of Medicine, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Charanjit', 'Initials': 'C', 'LastName': 'Rihal', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic Rochester, Rochester, MN, United States.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Medicine, National Heart, Lung, and Blood Institute, Bethesda, MD, United States.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Bailey', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic Rochester, Rochester, MN, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farkouh', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Bell', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic Rochester, Rochester, MN, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Cagin', 'Affiliation': 'Department of Medicine, Mayo Clinic Health System, La Crosse, WI, United States.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Chavez', 'Affiliation': 'Department of Medicine, Minneapolis Heart Institute, Minneapolis, MN, United States.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'El-Hajjar', 'Affiliation': 'Department of Medicine, Albany Medical College, Albany, NY, United States.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Ginete', 'Affiliation': 'Department of Medicine, Essentia Institute of Rural Health, Duluth, MN, United States.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic Rochester, Rochester, MN, United States.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Levisay', 'Affiliation': 'Department of Medicine, Northshore University Health System, Evanston, IL, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Marzo', 'Affiliation': 'Department of Medicine, Winthrop University Hospital, Mineola, NY, United States.'}, {'ForeName': 'Tamim', 'Initials': 'T', 'LastName': 'Nazif', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY, United States.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Olgin', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pereira', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic Rochester, Rochester, MN, United States.'}]",JMIR formative research,['10.2196/34080']
1938,35699976,The Role of Agency and Threat Immediacy in Interactive Digital Narrative Fear Appeals for the Prevention of Excessive Alcohol Use: Randomized Controlled Trial.,"BACKGROUND


Serious games for the training of prevention behaviors have been widely recognized as potentially valuable tools for adolescents and young adults across a variety of risk behaviors. However, the role of agency as a distinguishing factor from traditional health interventions has seldom been isolated and grounded in the persuasive health communication theory. Fear appeals have different effects on intentions to perform prevention behaviors depending on the immediacy of the consequences. Looking into how to increase self-efficacy beliefs for health behavior with distant consequences is the first step toward improving game-based interventions for adverse health outcomes.
OBJECTIVE


This study aimed to investigate the effect of agency on self-efficacy and the intention to drink less alcohol in an interactive digital narrative fear appeal. Furthermore, the communicated immediacy of threat outcomes was evaluated as a potential moderator of the effect of agency on self-efficacy.
METHODS


A web-based experimental study was conducted with university students (N=178). The participants were presented with a fear appeal outlining the consequences of excessive alcohol use in a fully automated web-based interactive narrative. Participants either had perceived control over the outcome of the narrative scenario (high agency) or no control over the outcome (low agency). The threat was either framed as a short-term (high immediacy) or long-term (low immediacy) negative health outcome resulting from the execution of the risk behavior (drinking too much alcohol).
RESULTS


A total of 123 valid cases were analyzed. Self-efficacy and intention to limit alcohol intake were not influenced by the agency manipulation. Self-efficacy was shown to be a significant predictor of behavioral intention. The immediacy of the threat did not moderate the relationship between agency and self-efficacy.
CONCLUSIONS


Although agency manipulation was successful, we could not find evidence of an effect of agency or threat immediacy on self-efficacy. The implications for different operationalizations of different agency concepts, as well as the malleability of self-efficacy beliefs for long-term threats, are discussed. The use of repeated versus single interventions and different threat types (eg, health and social threats) should be tested empirically to establish a way forward for diversifying intervention approaches.
TRIAL REGISTRATION


ClinicalTrials.gov NCT05321238; https://www.clinicaltrials.gov/ct2/show/NCT05321238.",2022,"Although agency manipulation was successful, we could not find evidence of an effect of agency or threat immediacy on self-efficacy.","['adolescents and young adults', 'Participants either had perceived control over the outcome of the narrative scenario (high agency) or no control over the outcome (low agency', 'A web-based experimental study was conducted with university students (N=178']",[],"['Self-efficacy and intention to limit alcohol intake', 'Self-efficacy']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",123.0,0.0396835,"Although agency manipulation was successful, we could not find evidence of an effect of agency or threat immediacy on self-efficacy.","[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Engelbrecht', 'Affiliation': 'Tilburg School of Humanities and Digital Sciences, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Laura Nynke', 'Initials': 'LN', 'LastName': 'van der Laan', 'Affiliation': 'Tilburg School of Humanities and Digital Sciences, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Renske', 'Initials': 'R', 'LastName': 'van Enschot', 'Affiliation': 'Tilburg School of Humanities and Digital Sciences, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Emiel', 'Initials': 'E', 'LastName': 'Krahmer', 'Affiliation': 'Tilburg School of Humanities and Digital Sciences, Tilburg University, Tilburg, Netherlands.'}]",JMIR serious games,['10.2196/32218']
1939,35700207,Cost-effectiveness analysis of bundled innovative devices versus standard approach in the prevention of unscheduled peripheral venous catheters removal due to complications in France.,"The objective of the study was to perform a cost-effectiveness analysis of bundled devices (BDs) versus standard devices (SDs) for the prevention of unscheduled peripheral venous catheter (PVC) removal due to complication from a French investigator-initiated, open-label, single center, randomized-controlled, two-by-two factorial trial (CLEAN-3 study). A 14-day time non homogeneous semi-markovian model was performed to be fitted to longitudinal individual patient data from CLEAN-3 database. This model includes five health states and eight transitional events; a base case scenario, two scenario analyses and bootstrap sensitivity analyses were performed. The cost-effectiveness criterion was the cost per patient with unscheduled PVC removal avoided. 989 adult (age≥18 years) patients were analyzed to compare the BDs group (494 patients), and the SDs group (495 patients). The assessed intervention was a combination of closed integrated catheters, positive displacement needleless-connectors, disinfecting caps, and single-use prefilled flush syringes compared with the use of open catheters and three-way stopcocks for treatment administration. For the base case scenario, an unscheduled 1st PVC removal before discharge was significantly more frequent in the SDs group (235 patients (47.5%) in the SDs group and 172 patients (34.8%) in the BDs group, p = 0.00006). After adjustment for 1st catheter time, the number of patients with unscheduled PVC removal per day was of 16 (95%CI: 15; 18) patients (out of 100) in the BDs group and of 26 (95%CI: 24; 28) patients (out of 100) in the SDs group. The mean cost per patient (adjusted on catheter-time) was of €144 (95%CI: €135-€154) for patients in the SDs group versus €102 (95%CI: €95-€109) for patients in the BDs group; the mean saving per patient was of €42 (95%CI: €32-€54). As a consequence, the assessed BDs strategy was less costly and more effective than the SDs strategy. Trail registration: CLEAN-3 study is registered with ClinicalTrials.gov, NCT03757143.",2022,The mean cost per patient (adjusted on catheter-time) was of €144 (95%CI: €135-€154) for patients in the SDs group versus €102 (95%CI: €95-€109) for patients in the BDs group;,"['unscheduled peripheral venous catheters removal due to complications in France', '989 adult (age≥18 years) patients were analyzed to compare the BDs group (494 patients), and the SDs group (495 patients']","['bundled devices (BDs) versus standard devices (SDs', 'bundled innovative devices versus standard approach', 'closed integrated catheters, positive displacement needleless-connectors, disinfecting caps, and single-use prefilled flush syringes']","['cost-effectiveness criterion', 'unscheduled 1st PVC removal before discharge', 'mean cost per patient']","[{'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",989.0,0.0632322,The mean cost per patient (adjusted on catheter-time) was of €144 (95%CI: €135-€154) for patients in the SDs group versus €102 (95%CI: €95-€109) for patients in the BDs group;,"[{'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Maunoury', 'Affiliation': 'Statesia, Le Mans, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Drugeon', 'Affiliation': 'Emergency Department and Pre-Hospital Care, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Boisson', 'Affiliation': 'School of Medicine and Pharmacy, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Marjanovic', 'Affiliation': 'Emergency Department and Pre-Hospital Care, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Couvreur', 'Affiliation': 'Emergency Department and Pre-Hospital Care, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mimoz', 'Affiliation': 'Emergency Department and Pre-Hospital Care, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Guenezan', 'Affiliation': 'Emergency Department and Pre-Hospital Care, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0269750']
1940,35700161,One-stage versus two-stage technique using two splinted extra-short implants: A multicentric split-mouth study with a one-year follow-up.,"OBJECTIVE


To compare the clinical outcomes of extra-short implants (≤6.5 mm) inserted with one-stage versus two-stage technique in adjacent sites of the upper or lower jaw.
MATERIALS AND METHODS


In this split-mouth multicenter study, implants were randomly divided into two groups according to the healing phase: two-stage and one-stage technique. Primary outcome measures were implant survival, implant success, and prosthodontic complications. Secondary outcome measurements were: implant stability quotient (ISQ) collected at surgery time (T0), and after 3 (T3) and 12 (T12) months, marginal bone level (MBL) evaluated at T0, T3, T6, and T12, marginal bone loss evaluated at T6 and T12, plaque index (PI), probing depth (PD), bleeding on probing (BoP) evaluated at T3, T6, and T12. Significances of differences between groups were tested by linear mixed model with random intercept.
RESULTS


Nineteen patients (8 males and 11 females) were included. A total of 38 implants were inserted. At T12 implant cumulative survival and implant success rate were 100% in both groups. No statistically significant differences were recorded for any of the analyzed parameters between the two groups at any time point. ISQ values were similar at T0 (two-stage: mean 67.53 ± SD 19.47; one-stage: mean 66.53 ± 19.07 p = 0.8738) and increased in both groups at the 12-month follow-up appointment (two-stage: 81.1 ± 7.04; one-stage: 81.39 ± 0.9266). MBL values were similar in the two groups at any time point. At T12 marginal bone loss was 0.46 ± 0.41 (two-stage) and 0.45 ± 0.38 (one-stage) mm (p = 0.9417), while mean PD was 2.7 ± 0.85 (two-stage) and 2.69 ± 0.89 (one-stage) mm.
CONCLUSIONS


Within the limits of the present short-term report, extra-short implants demonstrated optimal clinical outcomes using the one-stage technique, without statistically significant differences compared with the traditional two-stage approach.",2022,At T12 implant cumulative survival and implant success rate were 100% in both groups.,['Nineteen patients (8 males and 11 females'],['extra-short implants (≤6.5\u2009mm) inserted with one-stage versus two-stage technique in adjacent sites of the upper or lower jaw'],"['implant stability quotient (ISQ) collected at surgery time (T0), and after 3 (T3) and 12 (T12) months, marginal bone level (MBL) evaluated at T0, T3, T6, and T12, marginal bone loss evaluated at T6 and T12, plaque index (PI), probing depth (PD), bleeding on probing (BoP', 'ISQ values', 'implant survival, implant success, and prosthodontic complications', 'MBL values', 'cumulative survival and implant success rate']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0054967', 'cui_str': 'Lymphocyte antigen CD6'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",38.0,0.0552975,At T12 implant cumulative survival and implant success rate were 100% in both groups.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Menini', 'Affiliation': 'Division of Prosthodontics and Implant Prosthodontics, Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pesce', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Delucchi', 'Affiliation': 'Division of Prosthodontics and Implant Prosthodontics, Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Ambrogio', 'Affiliation': 'CIR Dental School Department of Surgical Sciences, University of Turin, Torino, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Canepa', 'Affiliation': 'Division of Prosthodontics and Implant Prosthodontics, Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Carossa', 'Affiliation': 'CIR Dental School Department of Surgical Sciences, University of Turin, Torino, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pera', 'Affiliation': 'CIR Dental School Department of Surgical Sciences, University of Turin, Torino, Italy.'}]",Clinical implant dentistry and related research,['10.1111/cid.13113']
1941,35700157,Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: Post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686].,"BACKGROUND


Edaravone slowed the rate of functional decline in subjects with amyotrophic lateral sclerosis (ALS) in phase 3 study MCI186-19 (Study 19). One of the Study 19 inclusion criteria was forced vital capacity (FVC) ≥80% of predicted (≥80%p). Therefore, the study provided no information on edaravone efficacy in subjects with FVC <80%p. In Study 19, 24-week, double-blind treatment was followed by open-label treatment where all subjects received edaravone. At 24 weeks, some subjects had FVC <80%p (FVC24 <80%p). This allowed for post-hoc assessment of the effects of edaravone in subgroups of subjects with FVC24 ≥80%p vs <80%p.
OBJECTIVE


To address the question of the efficacy of edaravone in ALS patients with FVC <80%p.
METHODS


Post-hoc analysis of Study 19 comparing edaravone efficacy at week 48 in subjects with FVC24 ≥80%p vs <80%p.
RESULTS


With edaravone treatment, subjects in both the FVC24 ≥80%p and the FVC24 <80%p subgroups experienced a reduction in ALS Functional Rating Scale-Revised (ALSFRS-R) score loss vs placebo subjects through week 48. For the FVC24 ≥80%p subgroup, the changes in ALSFRS-R scores from baseline to week 48 were -7.63 for edaravone-edaravone vs -9.69 for placebo-edaravone, a difference of 2.05 (P = .034; 95% CI: 0.16, 3.94). For the FVC24 <80%p subgroup, the changes in ALSFRS-R scores from baseline to week 48 were -10.26 for edaravone-edaravone vs -15.20 for placebo-edaravone, a difference of 4.94 (P = .0038; 95% CI: 1.64, 8.25). Linear regression analysis indicated that, in the FVC24 <80%p subgroup, there was a notable change in the slope of the ALSFRS-R score-vs-time graph after the start of edaravone treatment.
CONCLUSION


ALS subjects in the Study 19 placebo arm had a slowing in disease progression, even when edaravone was added with an FVC of <80%p prior to starting edaravone. A randomized, placebo-controlled study is needed to validate these post-hoc findings.",2022,<80%p subgroups experienced a reduction in ALS Functional Rating Scale-Revised (ALSFRS-R) score loss vs placebo subjects through week 48.,"['ALS patients with FVC <80%p', 'subjects with amyotrophic lateral sclerosis (ALS) in phase 3 study MCI186-19 (Study 19', 'amyotrophic lateral sclerosis with reduced forced vital capacity', 'ALS subjects in the Study 19', 'subjects with FVC <80%p', 'subgroups of subjects with FVC24 ≥80%p vs <80%p', 'subjects with FVC24 ≥80%p vs <80%p']","['FVC24', 'edaravone', 'placebo']","['ALSFRS-R scores', 'ALS Functional Rating Scale-Revised (ALSFRS-R) score loss', 'Edaravone efficacy', 'edaravone efficacy', 'slowing in disease progression']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0127159', 'cui_str': 'MCI-186'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.244153,<80%p subgroups experienced a reduction in ALS Functional Rating Scale-Revised (ALSFRS-R) score loss vs placebo subjects through week 48.,"[{'ForeName': 'Benjamin Rix', 'Initials': 'BR', 'LastName': 'Brooks', 'Affiliation': 'Atrium Health Neurosciences Institute, Carolinas Medical Center, University of North Carolina School of Medicine-Charlotte Campus, Charlotte, North Carolina, United States of America.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Heiman-Patterson', 'Affiliation': 'Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Wiedau-Pazos', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, United States of America.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Mitsubishi Tanabe Pharma Development America, Jersey City, New Jersey, United States of America.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Princeton Pharmatech, West Windsor, New Jersey, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Apple', 'Affiliation': 'Mitsubishi Tanabe Pharma America, Inc., Jersey City, New Jersey, United States of America.'}]",PloS one,['10.1371/journal.pone.0258614']
1942,35700149,Avocado consumption for 12 weeks and cardio-metabolic risk factors: a randomized controlled trial in adults with overweight or obesity and insulin resistance.,"BACKGROUND


Diets emphasizing unsaturated fat and high fiber are associated with reducing cardio-metabolic risk factors. Avocados are rich in mono- and poly-unsaturated fats and fiber.
OBJECTIVE


Assess replacement of carbohydrate energy with avocado energy for 12 weeks on glucose homeostasis and cardio-metabolic risk factors in self-selecting free-living adults with overweight or obesity and insulin resistance.
METHODS


In a single-center, randomized, 2-arm, controlled, 12-week parallel trial, adults [n = 93, male: female 39:54, mean ± SD age 42 ± 12 years, BMI 32.6 ± 3.9 kg/m2,  homeostatic assessment for insulin resistance, 2.7 ± 1.7] were counseled to exchange avocado (AV) or control food (C, low-fat low-fiber energy-matched) for carbohydrate food in their usual diet for 12 weeks. The primary outcome was the change in Matsuda Insulin Sensitivity Index (MISI) after 12-week interventions. Secondary outcomes were changes in fasting and post-oral glucose tolerance test glycemic variables, fasting lipids, endothelial activation and inflammation markers. ASA24 dietary assessment tool captured weekly dietary intake. Intervention effects were mainly determined by analysis of covariance using PC-SAS, 9.4.
RESULTS


Dietary total, mono- and poly-unsaturated fat, fiber, and vegetable intake were higher in the AV group compared to C group (P < 0.05), and no change in body weight or composition was observed (P > 0.05). Differences between the changes in MISI after AV compared to C were not different (Δ0-12 week, P = 0.1092). Differences in fasting insulin (Δ0-12 week, P = 0.0855) and improved HbA1c (Δ0-12 week P = 0.0632) after AV vs C were suggested. C-reactive protein was significantly lower after AV vs C at 12 weeks (P = 0.0418). Select biomarkers of endothelial activation and lipoproteins by NMR were also influenced by AV vs C food intake.
CONCLUSIONS


Avocado intake was associated with a healthier dietary pattern and trends favoring improved glucose control and reduced biomarkers of cardiometabolic risk when replacing avocado energy for carbohydrate energy in free-living adults with overweight or obesity and insulin resistance.",2022,"Differences in fasting insulin (Δ0-12 week, P = 0.0855) and improved HbA1c (Δ0-12 week P = 0.0632) after AV vs C were suggested.","['adults with overweight or obesity and insulin resistance', 'SD age 42\xa0±\xa012\xa0years, BMI 32.6\xa0±\xa03.9\xa0kg/m2, \xa0homeostatic assessment for insulin resistance, 2.7\xa0±\xa01.7]\xa0were counseled to exchange avocado (AV) or control food (C, low-fat low-fiber energy-matched) for carbohydrate food in their usual diet for 12 weeks', 'adults [n\xa0=\xa093, male: female 39:54, mean\xa0±', 'self-selecting free-living adults with overweight or obesity and insulin resistance']","['carbohydrate energy with avocado energy', 'Avocado consumption']","['glucose homeostasis and cardio-metabolic risk factors', 'body weight or composition', 'fasting insulin', 'change in Matsuda Insulin Sensitivity Index (MISI', 'HbA1c', 'C-reactive protein', 'changes in fasting and post-oral glucose tolerance test glycemic variables, fasting lipids, endothelial activation and inflammation markers', 'Dietary total, mono- and poly-unsaturated fat, fiber, and vegetable intake']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0453802', 'cui_str': 'Carbohydrate food'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0015678', 'cui_str': 'Unsaturated fat'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}]",93.0,0.0547886,"Differences in fasting insulin (Δ0-12 week, P = 0.0855) and improved HbA1c (Δ0-12 week P = 0.0632) after AV vs C were suggested.","[{'ForeName': 'Xuhuiqun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Xiao', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Guzman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Burton-Freeman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research and Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL.'}]",The Journal of nutrition,['10.1093/jn/nxac126']
1943,35700681,"In-home online music-based intervention for stress, coping, and depression among family caregivers of persons with dementia: A pilot study.","Little is known about how music affects family caregivers who provide care to persons with dementia at home. We examined the effects of an 8-week online music-based intervention on self-reported stress, coping, and depression among dementia family caregivers. Mann-Whitney U test and Wilcoxon signed-ranked tests were performed to examine between- and within-group differences between intervention (n = 24) and comparison (n = 11) groups from baseline to post-test. The coping subscale yielded a significant difference between the groups at post-test (U=76.50, Z=-1.978, p=0.048), indicating the intervention group had better coping than the comparison group at post-test. Significant within-group differences in overall stress (Z=-2.200, p=0.028) and coping subscale (Z=-1.997, p=0.046) in the comparison group at post-test suggest that overall stress and coping were maintained throughout the study in the intervention group, whereas the comparison group had higher overall stress and lower coping at post-test. Our in-home music-based intervention showed potential benefits for dementia family caregivers.",2022,"Significant within-group differences in overall stress (Z=-2.200, p=0.028) and coping subscale (Z=-1.997, p=0.046) in the comparison group at post-test suggest that overall stress and coping were maintained throughout the study in the intervention group, whereas the comparison group had higher overall stress and lower coping at post-test.","['persons with dementia at home', 'dementia family caregivers', 'family caregivers of persons with dementia']",['8-week online music-based intervention'],"['overall stress and lower coping', 'overall stress and coping', 'overall stress', 'coping subscale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",24.0,0.0269107,"Significant within-group differences in overall stress (Z=-2.200, p=0.028) and coping subscale (Z=-1.997, p=0.046) in the comparison group at post-test suggest that overall stress and coping were maintained throughout the study in the intervention group, whereas the comparison group had higher overall stress and lower coping at post-test.","[{'ForeName': 'Hyejin', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Rush University College of Nursing, 600 South Paulina Street, Chicago, IL 60612, USA. Electronic address: hyejin_kim@rush.edu.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Engström', 'Affiliation': 'Dalarna University School of Education, Health, and Social Studies, Högskolegatan 2, 791 31 Falun, Sweden.'}, {'ForeName': 'Töres', 'Initials': 'T', 'LastName': 'Theorell', 'Affiliation': 'Stress Research Institute, Department of Psychology, Stockholm University, Sweden; Karolinska Institutet Department of International Health, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hallinder', 'Affiliation': 'Division of Occupational Therapy, Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Emami', 'Affiliation': 'Division of Occupational Therapy, Department of Neurobiology, Care Sciences, and Society, Karolinska Institutet, Stockholm, Sweden; University of Washington School of Nursing, 1959 NE Pacific Street, Seattle, WA 98195, USA.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.05.011']
1944,35700653,Communicating the risks of tobacco and alcohol co-use.,"BACKGROUND


While tobacco and alcohol co-use is highly prevalent across the United States, little experimental research has examined ways to counter such dual use. We developed and tested messages about the risks of co-using tobacco and alcohol among adults who used a combustible tobacco product and drank alcohol within the 30 days.
METHODS


In an online experiment, 1,300 participants were randomly assigned to read different messages about tobacco and alcohol co-use (e.g., Alcohol and tobacco cause throat cancer). Three between-subjects experiments manipulated the presence of: 1) a marker word (e.g., Warning), 2) text describing the symptoms of health effects and a quitting self-efficacy cue, and 3) an image depicting the health effect. Participants rated each message using a validated Perceived Message Effectiveness (PME) scale. We used independent samples t-tests to examine differences between experimental conditions. Results include effect sizes (Cohen's d) to compare standardized mean differences.
RESULTS


Our sample was 64% male, 70% white, 23% Black, and 17% Hispanic/Latino with a mean age of 42.4 (SD = 16.4) years. Messages that described the symptoms of the health effect (d = 0.17, p = 0.002) and included an image (d = 0.11, p = 0.04) were rated significantly higher in PME compared with messages that did not describe symptoms and were text-only. We found no significant effects of a marker word or self-efficacy cue on PME.
CONCLUSIONS


Messages that describe the symptoms of health effects and include text and images may be particularly effective for communicating the risks of tobacco and alcohol co-use and decreasing adverse health effects from co-use.",2022,"Messages that described the symptoms of the health effect (d = 0.17, p = 0.002) and included an image (","['adults who used a combustible tobacco product and drank alcohol within the 30\xa0days', '1,300 participants were randomly assigned to', 'Our sample was 64% male, 70% white, 23% Black, and 17% Hispanic/Latino with a mean age of 42.4 (SD\xa0=\xa016.4) years']","['read different messages about tobacco and alcohol co-use (e.g., Alcohol and tobacco cause throat cancer']","['marker word or self-efficacy cue on PME', 'Message Effectiveness (PME) scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0740339', 'cui_str': 'Throat cancer'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0751785', 'cui_str': 'Unverricht-Lundborg syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1300.0,0.00962491,"Messages that described the symptoms of the health effect (d = 0.17, p = 0.002) and included an image (","[{'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'Kowitt', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States. Electronic address: kowitt@email.unc.edu.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Cox', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Jarman', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.'}, {'ForeName': 'Amanda Y', 'Initials': 'AY', 'LastName': 'Kong', 'Affiliation': 'Department of Family and Preventive Medicine, College of Medicine, The University of Oklahoma Health Sciences Center, Oklahoma City, OK 73117, United States; TSET Health Promotion Research Center, Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, United States.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Sivashanmugam', 'Affiliation': 'School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cornacchione Ross', 'Affiliation': 'Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston Salem, NC 27157, United States.'}, {'ForeName': 'Adam O', 'Initials': 'AO', 'LastName': 'Goldstein', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ranney', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2022.107383']
1945,35700641,Physical activity does not impact mediolateral margin of stability across a range of postural-perturbing conditions in young adults.,"BACKGROUND


The maintenance of stability during walking is critical for successful locomotion. While targeted balance training can improve stability, it is unclear how simply meeting recommended physical activity guidelines may impact dynamic stability in healthy young adults.
RESEARCH QUESTION


Examining the differences in the mediolateral margin of stability (ML-MOS) and the variability of the ML-MOS in physically active and inactive young adults across a range of stability-challenging walking tasks METHOD: Twenty-one physically active and twenty inactive young adults completed four experimental walking conditions: (1) Overground Walking, (2) Tandem Walking, (3) Beam Walking, and (4) Stepping-Stones. The ML-MOS and coefficient of variation of the ML-MOS were calculated at each heel strike while participants walked at their preferred walking speed. A two-way mixed-effects ANOVA was conducted to examine the effects of group and condition and their interaction on ML-MOS and ML-MOS variability RESULTS: Neither the ML-MOS nor the variability of the ML-MOS was significantly different between physically active and physically inactive young adults during any experimental walking conditions. A significant main effect of the experimental walking condition was observed, with the ML-MOS decreasing from overground walking to the tandem and beam walking conditions. The ML-MOS also became more variable in the tandem, beam, and stepping-stones conditions than in overground gait.
SIGNIFICANCE


Physical activity status did not influence frontal plane dynamic balance in healthy young adults, even in stability-challenging environments. Conditions that constrain step width, such as tandem and beam walking, are adequate for challenging frontal plane dynamic balance and indicate that trunk kinematics may be adjusted when step width is constrained.",2022,Neither the ML-MOS nor the variability of the ML-MOS was significantly different between physically active and physically inactive young adults during any experimental walking conditions.,"[' Twenty-one physically active and twenty inactive young adults completed four', 'young adults', 'physically active and inactive young adults', 'healthy young adults']","['experimental walking conditions: (1) Overground Walking, (2) Tandem Walking, (3) Beam Walking, and (4) Stepping-Stones']","['mediolateral margin of stability (ML-MOS', 'frontal plane dynamic balance']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}]","[{'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",21.0,0.0280423,Neither the ML-MOS nor the variability of the ML-MOS was significantly different between physically active and physically inactive young adults during any experimental walking conditions.,"[{'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Monaghan', 'Affiliation': 'Auburn University, School of Kinesiology, USA. Electronic address: pgm0011@auburn.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Brinkerhoff', 'Affiliation': 'Auburn University, School of Kinesiology, USA. Electronic address: sab0042@auburn.edu.'}, {'ForeName': 'Jaimie A', 'Initials': 'JA', 'LastName': 'Roper', 'Affiliation': 'Auburn University, School of Kinesiology, USA. Electronic address: jroper@auburn.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2022.05.038']
1946,35700617,Kinesiotaping in the emergency department: The effect of kinesiotaping on acute pain due to uncomplicated traumatic injury of the shoulder or chest wall. A pilot study.,"INTRODUCTION


Traumatic injuries of the shoulder or chest wall are commonly treated in the Emergency Department (ED). A complementary treatment is kinesiotaping, an elastic tape often used to treat musculoskeletal dysfunction and pain. However, the added pain-reducing effect of kinesiotape in comparison to standard conservative treatment is unknown. The aim of this study was to determine the effect of kinesiotaping on pain relief compared to standard treatment with pain medication and immobilization in patients with uncomplicated traumatic injury of the shoulder or chest wall in the ED.
METHOD


A pilot randomized controlled trial (RCT) was conducted in the ED of a teaching hospital in the Netherlands from January 2021 until the end of March 2021. Patients diagnosed with uncomplicated isolated rib fractures, rib contusions, clavicle fracture, disruption of the AC joint and fracture of the proximal humerus were assigned to two treatment groups. The control group received the standard treatment with oral analgesics (acetaminophen q6h 1000 mg and NSAID (according to prescription) and if shoulder injury also a sling. The intervention group received kinesiotaping in addition to the same standard treatment. Pain intensity was measured with 0-10 Numeric Rating Scale (NRS) just before treatment (T1) and after 15 min (T2). On day 4 both groups were assessed with NRS in a follow up phone call (T3).
RESULTS


A total of 251 patients presented with traumatic injury of the shoulder or chest wall in the study period, 85 patients were approached to participate and 2 of them were excluded. The remaining 83 were randomly allocated to kinesiotaping (n = 40) or control group (n = 43), 57 of them completed the study and had sufficient data for complete analysis In both groups, pain intensity after 15 min and 4 days significantly reduced compared with baseline. Regarding the reduction of pain intensity on day 4, kinesiotaping was significantly superior compared to the control group with a difference in pain reduction of 2.45 compared with 0.88 in control group (p = 0.018).
CONCLUSION


Compared to standard treatment alone, kinesiotaping combined with standard care appears to be more effective in terms of acute pain reduction in patients with uncomplicated traumatic injury of the shoulder or chest wall. Further research is recommended.",2022,"Regarding the reduction of pain intensity on day 4, kinesiotaping was significantly superior compared to the control group with a difference in pain reduction of 2.45 compared with 0.88 in control group (p = 0.018).
","['Patients diagnosed with uncomplicated isolated rib fractures, rib contusions, clavicle fracture, disruption of the AC joint and fracture of the proximal humerus', 'patients with uncomplicated traumatic injury of the shoulder or chest wall', '251 patients presented with traumatic injury of the shoulder or chest wall in the study period, 85 patients were approached to participate and 2 of them were excluded', 'ED of a teaching hospital in the Netherlands from January 2021 until the end of March 2021', 'patients with uncomplicated traumatic injury of the shoulder or chest wall in the ED']","['kinesiotaping', 'pain medication and immobilization', 'kinesiotaping combined with standard care', 'standard treatment with oral analgesics (acetaminophen q6h 1000 mg and NSAID']","['pain relief', 'pain intensity', 'Pain intensity', 'pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C1997661', 'cui_str': 'Contusion of rib'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0585325', 'cui_str': 'Every six hours'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",85.0,0.0221163,"Regarding the reduction of pain intensity on day 4, kinesiotaping was significantly superior compared to the control group with a difference in pain reduction of 2.45 compared with 0.88 in control group (p = 0.018).
","[{'ForeName': 'Mireille E', 'Initials': 'ME', 'LastName': 'Bakker', 'Affiliation': 'Department of Emergency Medicine, OLVG Hospital, Amsterdam, the Netherlands. Electronic address: m.e.bakker2@olvg.nl.'}, {'ForeName': 'Victor J J', 'Initials': 'VJJ', 'LastName': 'Bon', 'Affiliation': 'Department of Emergency Medicine, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart P M', 'Initials': 'BPM', 'LastName': 'Huybrechts', 'Affiliation': 'Department of Emergency Medicine, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'Emergency Physician and Intensivist, Department of Emergency Medicine, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariska M S', 'Initials': 'MMS', 'LastName': 'Zwartsenburg', 'Affiliation': 'Emergency Physician and epidemiologist Department of Emergency Medicine, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Professor of Trauma Surgery, Department of Surgery, OLVG, Amsterdam, the Netherlands.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2022.05.057']
1947,35701067,"Tadalafil treatment for fetuses with early-onset growth restriction: a protocol for a multicentre, randomised, placebo-controlled, double-blind phase II trial (TADAFER IIb).","INTRODUCTION


TheTADAlafil treatment for Fetuses with early-onset growth Restriction: multicentrer, randomizsed, phase II trial (TADAFER II) study showed the possibility of prolonging the pregnancy period in cases of early-onset fetal growth restriction; however, it was an open-label study. To establish further evidence for the efficacy of tadalafil in this setting, we planned a multicentre, randomised, placebo-controlled, double-blind trial.
METHODS AND ANALYSIS


This trial will be conducted in 180 fetuses with fetal growth restriction enrolled from medical centres in Japan; their mothers will be randomised into three groups: arm A, receiving two times per day placebo; arm B, receiving one time per day 20 mg tadalafil and one time per day placebo and arm C, receiving 20 mg two times per day tadalafil. The primary endpoint is the prolongation of gestational age at birth, defined as days from the first day of the protocol-defined treatment to birth. To minimise bias in terms of fetal baseline conditions and timing of delivery, a fetal indication for delivery as in TADAFER II will be established in this trial. The investigator will evaluate fetal baseline conditions at enrolment and decide the timing of delivery based on this indication.
ETHICS AND DISSEMINATION


This study has been approved by Mie University Hospital Clinical Research Review Board on 22 July 2019 (S2018-007). Written informed consent will be obtained from all mothers before recruitment. Our findings will be widely disseminated through peer-reviewed publications.
TRIAL REGISTRATION


jRCTs041190065.",2022,"This trial will be conducted in 180 fetuses with fetal growth restriction enrolled from medical centres in Japan; their mothers will be randomised into three groups: arm A, receiving two times per day placebo; arm B, receiving one time per day 20 mg tadalafil and one time per day placebo and arm C, receiving 20 mg two times per day tadalafil.","['180 fetuses with fetal growth restriction enrolled from medical centres in Japan; their mothers', 'Fetuses with early-onset growth Restriction', '22 July 2019 (S2018-007', 'fetuses with early-onset growth restriction']","['Tadalafil', 'tadalafil and one time per day placebo and arm C, receiving 20\u2009mg two times per day tadalafil', 'tadalafil', 'placebo']","['prolongation of gestational age at birth, defined as days from the first day of the protocol-defined treatment to birth']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0439511', 'cui_str': 'times/day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",180.0,0.376141,"This trial will be conducted in 180 fetuses with fetal growth restriction enrolled from medical centres in Japan; their mothers will be randomised into three groups: arm A, receiving two times per day placebo; arm B, receiving one time per day 20 mg tadalafil and one time per day placebo and arm C, receiving 20 mg two times per day tadalafil.","[{'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Maki', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Tsu, Mie, Japan s-maki@med.mie-u.ac.jp.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Tsu, Mie, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Takakura', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Tsu, Mie, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Nii', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Tsu, Mie, Japan.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Tsu, Mie, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ogura', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Tsu, Mie, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Kotera', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Tsu, Mie, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Tsu, Mie, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tamaru', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Tsu, Mie, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Ushida', 'Affiliation': 'Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Obstetrics and Gynecology, Shinshu University Graduate School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shinshu University Graduate School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Tadatsugu', 'Initials': 'T', 'LastName': 'Kinjo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of the Ryukyus, Nakagami-gun, Okinawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawamura', 'Affiliation': 'Department of Obstetrics and Gynecology, Fukui University Graduate School of Medicine, Fukui, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Takano', 'Affiliation': 'Department of Obstetrics and Gynecology, Toho University Faculty of Medicine, Otaku, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Sachie', 'Initials': 'S', 'LastName': 'Suga', 'Affiliation': 'Department of Obstetrics and Gynecology, National Hospital Organization Nagasaki Medical Center, Omura, Nagasaki, Japan.'}, {'ForeName': 'Michi', 'Initials': 'M', 'LastName': 'Kasai', 'Affiliation': 'Perinatal Center for Maternity and Neonate, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yasui', 'Affiliation': 'Department of Obstetrics and Gynecology, Showa University Graduate School of Medicine, Shinagawa-ku, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Nagao', 'Affiliation': 'Department of Obstetrics and Gynecology, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Maegawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie Chuo Medical Center, Tsu, Mie, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Kotani', 'Affiliation': 'Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Yasuhi', 'Affiliation': 'Department of Obstetrics and Gynecology, National Hospital Organization Nagasaki Medical Center, Omura, Nagasaki, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Perinatal Center for Maternity and Neonate, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Aoki', 'Affiliation': 'Department of Obstetrics and Gynecology, University of the Ryukyus, Nakagami-gun, Okinawa, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Obstetrics and Gynecology, Fukui University Graduate School of Medicine, Fukui, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nakata', 'Affiliation': 'Department of Obstetrics and Gynecology, Toho University Faculty of Medicine, Otaku, Tokyo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Sekizawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Showa University Graduate School of Medicine, Shinagawa-ku, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Tsu, Mie, Japan.'}]",BMJ open,['10.1136/bmjopen-2021-054925']
1948,35701062,Patients' acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualitative secondary analysis of a mixed-method randomised clinical trial.,"OBJECTIVES


We examined the efficacy of case management (CM) interventions to encourage participation in colorectal cancer screening for patients with schizophrenia. This study aimed to clarify patients' acceptability of the intervention and the helpful components of the intervention. Simultaneously, the study aimed to determine the acceptability, appropriateness and feasibility of the intervention from the perspective of psychiatric care providers.
STUDY DESIGN AND SETTING


This study was a secondary qualitative analysis of a mixed-method randomised controlled trial that evaluated the efficacy of the CM approach to encourage participation in cancer screening for people with schizophrenia. The intervention comprised education and patient navigation for colorectal cancer screening. Interviews were conducted with patients who received the intervention and staff from two psychiatric hospitals in Japan who delivered the intervention.
PARTICIPANTS


Of the 172 patients with schizophrenia who participated in the trial, 153 were included. In addition, three out of six providers were included.
DATA COLLECTION AND ANALYSIS


Using a structured interview, the case manager asked participants about patient acceptability and the helpful components of the intervention. Content analysis was conducted for the responses obtained, and the number of responses was tabulated by two researchers. For the interviews with the providers, opinions obtained from verbatim transcripts were extracted and summarised.
RESULTS


Forty-three of the 56 patients perceived that the intervention was acceptable. For the intervention component, inperson counselling with an explanation of the screening process by psychiatric care providers was most frequently reported by the patients as helpful (48 of the 68 respondents). Psychiatric care providers evaluated the intervention as acceptable, appropriate and easy to understand and administer. However, providing the intervention to all patients simultaneously was considered difficult with the current human resources.
CONCLUSIONS


This study showed that the CM intervention was perceived as acceptable by patients and acceptable and appropriate by psychiatric care providers.
TRIAL REGISTRATION NUMBER


UMIN000036017.",2022,"For the intervention component, inperson counselling with an explanation of the screening process by psychiatric care providers was most frequently reported by the patients as helpful (48 of the 68 respondents).","['patients who received the intervention and staff from two psychiatric hospitals in Japan who delivered the intervention', 'Of the 172 patients with schizophrenia who participated in the trial, 153 were included', 'people with schizophrenia', 'patients with schizophrenia']","['intervention comprised education and patient navigation for colorectal cancer screening', 'CM approach', 'CM intervention', 'case management (CM) interventions']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],172.0,0.0801033,"For the intervention component, inperson counselling with an explanation of the screening process by psychiatric care providers was most frequently reported by the patients as helpful (48 of the 68 respondents).","[{'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Hospital, Okayama, Japan mfujiwara@okayama-u.ac.jp minagaki@med.shimane-u.ac.jp.'}, {'ForeName': 'Taichi', 'Initials': 'T', 'LastName': 'Shimazu', 'Affiliation': 'Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Etoh', 'Affiliation': 'Department of Nursing, Shimane University Hospital, Izumo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kodama', 'Affiliation': 'Okayama Psychiatric Medical Center, Okayama, Japan.'}, {'ForeName': 'Ryuhei', 'Initials': 'R', 'LastName': 'So', 'Affiliation': 'Okayama Psychiatric Medical Center, Okayama, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Matsushita', 'Affiliation': 'Zikei Hospital, Okayama, Japan.'}, {'ForeName': 'Yusaku', 'Initials': 'Y', 'LastName': 'Yoshimura', 'Affiliation': 'Zikei Hospital, Okayama, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Horii', 'Affiliation': 'Zikei Hospital, Okayama, Japan.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fujimori', 'Affiliation': 'Division of Supportive Care, Survivorship and Translational Research, National Cancer Center Institute for Cancer Control, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Division of Screening Assessment and Management, National Cancer Center Institute for Cancer Control, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nakaya', 'Affiliation': 'Tohoku Medical Megabank Organization, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Hinotsu', 'Affiliation': 'Department of Biostatistics and Data Management, Sapporo Medical University, Sapporo, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Gastroenterology, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Group for Supportive Care and Survivorship Research, National Cancer Center Institute for Cancer Control, Tokyo, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Inagaki', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Shimane University, Izumo, Japan mfujiwara@okayama-u.ac.jp minagaki@med.shimane-u.ac.jp.'}]",BMJ open,['10.1136/bmjopen-2021-060621']
1949,35701060,RadBone: bone toxicity following pelvic radiotherapy - a prospective randomised controlled feasibility study evaluating a musculoskeletal health package in women with gynaecological cancers undergoing pelvic radiotherapy.,"INTRODUCTION


Patients receiving radiotherapy are at risk of developing radiotherapy-related insufficiency fractures, which are associated with increased morbidity and pose a significant burden to patients' quality of life and to the health system. Therefore, effective preventive techniques are urgently required. The RadBone randomised controlled trial (RCT) aims to determine the feasibility and acceptability of a musculoskeletal health package (MHP) intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and to preliminary explore clinical effectiveness of the intervention.
METHODS AND ANALYSIS


The RadBone RCT will evaluate the addition to standard care of an MHP consisting of a physical assessment of the musculoskeletal health, a 3-month prehabilitation personalised exercise package, as well as an evaluation of the fracture risk and if required the prescription of appropriate bone treatment including calcium, vitamin D and-for high-risk individuals-bisphosphonates. Forty participants will be randomised in each group (MHP or observation) and will be followed for 18 months. The primary outcome of this RCT will be feasibility, including the eligibility, screening and recruitment rate, intervention fidelity and attrition rates; acceptability and health economics. Clinical effectiveness and bone turnover markers will be evaluated as secondary outcomes.
ETHICS AND DISSEMINATION


This study has been approved by the Greater Manchester East Research Ethics Committee (Reference: 20/NW/0410, November 2020). The results will be published in peer-reviewed journals, will be presented in national and international conferences and will be communicated to relevant stakeholders. Moreover, a plain English report will be shared with the study participants, patients' organisations and media.
TRIAL REGISTRATION NUMBER


NCT04555317.",2022,"The primary outcome of this RCT will be feasibility, including the eligibility, screening and recruitment rate, intervention fidelity and attrition rates; acceptability and health economics.","['Forty participants', 'women undergoing pelvic radiotherapy for gynaecological malignancies', 'women with gynaecological cancers undergoing pelvic radiotherapy']","['musculoskeletal health package (MHP) intervention', 'radiotherapy', 'RadBone', 'pelvic radiotherapy', 'musculoskeletal health package']","['feasibility, including the eligibility, screening and recruitment rate, intervention fidelity and attrition rates; acceptability and health economics', 'Clinical effectiveness and bone turnover markers']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",40.0,0.10902,"The primary outcome of this RCT will be feasibility, including the eligibility, screening and recruitment rate, intervention fidelity and attrition rates; acceptability and health economics.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Chatzimavridou Grigoriadou', 'Affiliation': 'Department of Endocrinology, The Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Barraclough', 'Affiliation': 'Department of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Baricevic-Jones', 'Affiliation': 'Stoller Biomarker Discovery Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Bristow', 'Affiliation': 'Division of Cancer Sciences, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eden', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Haslett', 'Affiliation': 'Department of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'Department of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Kochhar', 'Affiliation': 'Department of Radiology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Merchant', 'Affiliation': ""Greater Manchester 'Prehab4Cancer and Recovery programme'/Highly Specialist Occupational Therapist, GM Cancer alliance hosted by the Christie NHS Foundation Trust, Manchester, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'GM Cancer Clinical Director for Prehabilitation and Recovery, University of Manchester and Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Radiology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'The Christie Patient Centred Research Team, The Christie School of Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Westwood', 'Affiliation': 'Department of Radiology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony David', 'Initials': 'AD', 'LastName': 'Whetton', 'Affiliation': 'Stoller Biomarker Discovery Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Yorke', 'Affiliation': 'Department of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Higham', 'Affiliation': 'Department of Endocrinology, The Christie Hospital NHS Foundation Trust, Manchester, UK claire.higham2@nhs.net.'}]",BMJ open,['10.1136/bmjopen-2021-056600']
1950,35701054,Health literacy in context: struggling to self-manage diabetes - a longitudinal qualitative study.,"OBJECTIVES


Considering health literacy needs is a key component of health services responsiveness to diabetes self-management among vulnerable individuals. The purpose of this qualitative study was to provide a detailed analysis of the health literacy of people with type 2 diabetes in relation to their daily self-care practices.
DESIGN


Nested qualitative study in the ERMIES randomised controlled trial testing a 2-year structured care in type 2 diabetes. First round of semidirected interviews at the beginning of the trial with thematic analysis of content. Second round at the completion with directed interviews guided by the first round's themes together with Health Literacy Questionnaire.
SETTINGS


Interviews conducted at home.
PARTICIPANTS


Forty-four (31 females/13 males, 30-79 years, glycated haemoglobin (HbA1c)≥7.5%) consecutive participants out of 100 recruited in the ERMIES trial from 4 diabetology outpatient settings (Reunion Island). Forty-two respondents to the second round interviews.
RESULTS


Three poles structured into eight themes characterised practices in context: health knowledge, disease management, expertise and social support. The relationships of participants in each of the eight themes were differentiated, ranging from functional to interactive and critical. Treatment and follow-up were essentially functional, while diet and exercise remained more interactive. Social support and relationship to health professionals were important determinants of disease management.
CONCLUSIONS


Treatment management and disease monitoring remain primarily the job of health professionals, as opposed to diet, physical activity and social support being part of ordinary practice. Decision-making, as a shared social task, as well as resources for participation in health services, should be considered for relevant interventions in type 2 diabetes.
TRIAL REGISTRATION NUMBER


NCT01425866.",2022,"Social support and relationship to health professionals were important determinants of disease management.
","['people with type 2 diabetes in relation to their daily self-care practices', 'vulnerable individuals', 'Interviews conducted at home', 'consecutive participants out of 100 recruited in the ERMIES trial from 4 diabetology outpatient settings (Reunion Island', 'Forty-four (31 females/13 males, 30-79 years, glycated haemoglobin (HbA1c)≥7.5']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0567459', 'cui_str': 'Self-care practice'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0035373', 'cui_str': 'Reunion'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",[],[],100.0,0.0527501,"Social support and relationship to health professionals were important determinants of disease management.
","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Debussche', 'Affiliation': 'Centre Expert Plaies Chroniques, Centre Hospitalier Max Querrien, Paimpol, France xavier.debussche@inserm.fr.'}, {'ForeName': 'Maryvette', 'Initials': 'M', 'LastName': 'Balcou-Debussche', 'Affiliation': 'ICARE EA7389 Austral Cooperative Institute for Research in Education, Reunion University, Saint-Denis, Réunion.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Ballet', 'Affiliation': 'ICARE EA7389 Austral Cooperative Institute for Research in Education, Reunion University, Saint-Denis, Réunion.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Caroupin-Soupoutevin', 'Affiliation': 'ICARE EA7389 Austral Cooperative Institute for Research in Education, Reunion University, Saint-Denis, Réunion.'}]",BMJ open,['10.1136/bmjopen-2020-046759']
1951,35704475,Fat Grafting With Expanded Adipose-derived Stromal Cells for Breast Augmentation: A Randomized Controlled Trial.,"BACKGROUND


The main challenge with fat grafting is that a varying part of the graft is lost to post-surgery resorption. Previous studies suggest that adipose-derived stromal cells (ASCs) can improve the volume retention of fat grafts but there is a lack of randomized trials to support its use in clinical practice.
OBJECTIVES


This trial aimed to investigate whether ASCs improve fat graft volume retention in patients undergoing breast augmentation with lipofilling.
METHODS


This was a double-blind, randomized controlled trial of breast augmentation with ASC-enriched fat grafting. Healthy women aged 30-45 years were enrolled. First, the participants underwent liposuction to obtain fat for culture expansion of ASCs. Then, the participants were randomized to undergo a 300-350 cc breast augmentation with ASC-enriched fat grafting to one of their breasts and placebo-enriched fat grafting with identical volume to the contralateral breast. A dose of 10 x 10 6 ASCs/mL fat graft was applied. The primary outcome was fat graft volume retention after 1 year's follow-up measured with MRI. The trial is registered at w ww.clinicaltrialsregister.eu (EudraCT-2014-000510-59).
RESULTS


Ten participants were included in the trial; all completed the treatment and follow-up. No serious adverse events occurred. Fat graft volume retention after 1 year was 54.0% [95% CI 30.4-77.6] in the breasts treated with ASC-enriched fat grafting (n=10) and 55.9% [95% CI 28.9-82.9] in the contralateral breasts treated with placebo-enriched fat grafting (n=10) (p=0.566).
CONCLUSIONS


The findings of this trial do not support that ASC-enriched fat grafting is superior to standard fat grafting for breast augmentation.",2022,"Fat graft volume retention after 1 year was 54.0% [95% CI 30.4-77.6] in the breasts treated with ASC-enriched fat grafting (n=10) and 55.9% [95% CI 28.9-82.9] in the contralateral breasts treated with placebo-enriched fat grafting (n=10) (p=0.566).
","['Breast Augmentation', 'Ten participants were included in the trial; all completed the treatment and follow-up', 'Healthy women aged 30-45 years were enrolled', 'patients undergoing breast augmentation with lipofilling']","['ASCs', 'ASC-enriched fat grafting', '300-350 cc breast augmentation with ASC-enriched fat grafting to one of their breasts and placebo-enriched fat grafting with identical volume to the contralateral breast', 'adipose-derived stromal cells (ASCs', 'Fat Grafting With Expanded Adipose-derived Stromal Cells', 'placebo-enriched fat grafting']","['Fat graft volume retention', ""fat graft volume retention after 1 year's follow-up measured with MRI""]","[{'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C3710940', 'cui_str': 'STS protein, human'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",10.0,0.312089,"Fat graft volume retention after 1 year was 54.0% [95% CI 30.4-77.6] in the breasts treated with ASC-enriched fat grafting (n=10) and 55.9% [95% CI 28.9-82.9] in the contralateral breasts treated with placebo-enriched fat grafting (n=10) (p=0.566).
","[{'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Vester-Glowinski', 'Affiliation': 'Department of Plastic Surgery and Burns, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Herly', 'Affiliation': 'Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ørholt', 'Affiliation': 'Department of Plastic Surgery and Burns, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bo S', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'AK Nygart Private Hospital, København, Denmark.'}, {'ForeName': 'Felix C', 'Initials': 'FC', 'LastName': 'Müller', 'Affiliation': 'Department of Radiology, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Elberg', 'Affiliation': 'Physician in private practice in Copenhagen, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Thomsen', 'Affiliation': 'Department of Radiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Krzysztof T', 'Initials': 'KT', 'LastName': 'Drzewiecki', 'Affiliation': 'Department of Plastic Surgery and Burns, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Aesthetic surgery journal,['10.1093/asj/sjac159']
1952,35704472,Peri-implant tissue health and patient satisfaction of vertical versus inclined posterior implants used to support overdentures with bar attachments. A one-year randomized trial.,"INTRODUCTION


This study aimed to evaluate peri-implant tissue health and patient satisfaction of vertical and inclined posterior implants for mandibular bar overdentures.
MATERIALS AND METHODS


Thirty edentulous participants received four implants in the interforaminal area of the mandible. The patients were randomly assigned into two equal groups; (1) vertical group (control): all implants were inserted vertically parallel to each other. Inclined group (study): the anterior implants were placed vertically, and the posterior implants were tilted 30° distally. Hader bar attachment with two 7 mm-distal cantilevers (vertical group) and without cantilevers (inclined group) was used to connect the implants to mandibular overdentures. Peri-implant tissue health (Plaque [PL] and gingival [GI] indices, pocket depth [PD], and crestal bone loss [CBL]) were evaluated after denture insertion (T0), 6 (T6), and 12 (T12) months after insertion. Patient satisfaction was evaluated using a visual analog scale after 12 months.
RESULTS


At T12, the vertical group showed significantly higher PL, PD, and CBL than the inclined group for anterior (p < 0.037) and posterior (p < 0.017) implants. The vertical group showed significantly higher GI than the inclined group for anterior implants (p = 0.003), and the inclined group showed significantly higher GI than the vertical group for posterior implants (p = 0.016). The inclined group showed significantly higher scores for general satisfaction (p = 0.049), prosthesis as a part of you (p = 0.013), appearance (p < 0.001), stability (p = 0.002), ease of cleaning (p < 0.001), and comfort (p = 0.001) than the vertical group.
CONCLUSION


Inclined posterior implants used to support mandibular bar overdentures are recommended than vertical implants, as it was associated with improved patient satisfaction and peri-implant tissue health.",2022,"The vertical group showed significantly higher GI than the inclined group for anterior implants (p = 0.003), and the inclined group showed significantly higher GI than the vertical group for posterior implants (p = 0.016).",['Thirty edentulous participants received four implants in the interforaminal area of the mandible'],['Peri-implant tissue health and patient satisfaction of vertical versus inclined posterior implants'],"['Peri-implant tissue health (Plaque [PL] and gingival [GI] indices, pocket depth [PD], and crestal bone loss [CBL', 'ease of cleaning', 'PL, PD, and CBL', 'higher GI', 'visual analog scale', 'Patient satisfaction', 'general satisfaction', 'stability']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",30.0,0.0374027,"The vertical group showed significantly higher GI than the inclined group for anterior implants (p = 0.003), and the inclined group showed significantly higher GI than the vertical group for posterior implants (p = 0.016).","[{'ForeName': 'Christine Raouf Micheal', 'Initials': 'CRM', 'LastName': 'Ibrahim', 'Affiliation': 'Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'SallySayed', 'Initials': 'S', 'LastName': 'Awad', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed Ali', 'Initials': 'AA', 'LastName': 'Habib', 'Affiliation': 'Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Moustafa Abdou', 'Initials': 'MA', 'LastName': 'Elsyad', 'Affiliation': 'Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.'}]",Clinical implant dentistry and related research,['10.1111/cid.13105']
1953,35704468,The effectiveness and safety of ibuprofen and acetylsalicylic acid in acute rheumatic fever.,"BACKGROUND


Acetylsalicylic acid (ASA) is a non-steroidal anti-inflammatory drug used in the treatment of acute rheumatic fever (ARF) and it can cause serious adverse effects. This study aimed to evaluate the clinical efficacy and side effects of ibuprofen in the treatment of ARF compared to the classic treatment, ASA.
METHODS


Children who were hospitalized for the treatment of ARF with isolated arthritis and mild carditis between October 2015 and October 2018 and who received non-steroidal anti-inflammatory therapy were evaluated in the study. We compared the demographic data, clinical findings, efficacy, and side effects of the treatments of the children, who were divided into ASA and ibuprofen groups.
RESULTS


Of the 38 patients included in the study, 21 were treated with ASA (ASA group), and 17 were given ibuprofen (IBU group). There was no difference between the groups regarding the length of hospital stay, total treatment time, time to resolution of clinical symptoms, and normalization of acute-phase reactants. Liver enzymes increased during treatment in 13 patients (62%) in the ASA group and three patients (18%) in the IBU group (P = 0.009). In the ASA group, 69% of patients with increased liver enzymes were under 11 years of age during treatment. Clinical side effects were observed in three patients in the ASA group while none were observed in the IBU group.
CONCLUSION


The results of this study suggest that ibuprofen can be a safe alternative in the treatment of ARF, especially in young children. Although ibuprofen can be a safe and effective alternative to ASA, studies including larger series are needed on this subject.",2022,"There was no difference between the groups regarding the length of hospital stay, total treatment time, time to resolution of clinical symptoms, and normalization of acute-phase reactants.","['acute rheumatic fever', 'Children who were hospitalized for the treatment of ARF with isolated arthritis and mild carditis between October 2015 and October 2018 and who received non-steroidal anti-inflammatory therapy were evaluated in the study', '38 patients included in the study', 'young children']","['ibuprofen', 'ibuprofen and acetylsalicylic acid', 'Acetylsalicylic acid (ASA']","['Clinical side effects', 'Liver enzymes', 'liver enzymes', 'length of hospital stay, total treatment time, time to resolution of clinical symptoms, and normalization of acute-phase reactants']","[{'cui': 'C0035436', 'cui_str': 'Rheumatic fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0869523', 'cui_str': 'Carditis'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001347', 'cui_str': 'Acute phase reactant'}]",,0.0107903,"There was no difference between the groups regarding the length of hospital stay, total treatment time, time to resolution of clinical symptoms, and normalization of acute-phase reactants.","[{'ForeName': 'Münevver', 'Initials': 'M', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Pediatric Cardiology, Faculty of Medicine, Pamukkale University Denizli, Denizli, Turkey.'}, {'ForeName': 'Dolunay', 'Initials': 'D', 'LastName': 'Gürses', 'Affiliation': 'Department of Pediatric Cardiology, Faculty of Medicine, Pamukkale University Denizli, Denizli, Turkey.'}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Tükenmez', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Pamukkale University Denizli, Denizli, Turkey.'}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.15133']
1954,35704338,Predictors of Adherence Among Vulnerable Populations of Adults Assigned to Smoke Very Low Nicotine Content Cigarettes.,"INTRODUCTION


Regulators are considering reducing the nicotine content in cigarettes to a minimally addictive level. This could particularly benefit smokers from populations vulnerable to heavy smoking and difficulties quitting. We assessed predictors of adherence among adults from vulnerable populations assigned to use very low nicotine content cigarettes (VLNCs) in randomized clinical trials, to identify characteristics of those who require additional assistance if a nicotine-reduction policy were implemented.
METHOD


Data came from three populations of vulnerable adult smokers assigned to use VLNC cigarettes (0.4 mg/g nicotine) during 12-week randomized controlled trials (n=286): socioeconomically disadvantaged women of reproductive age, opioid-maintained adults, and adults with affective disorders. Logistic and linear regressions modeled predictors of adherence based on changes in cotinine at Week-6 and -12 assessments relative to baseline, and as a 90% reduction in cotinine relative to baseline (full adherence: yes/no). Predictors included satisfaction with study cigarettes, craving, nicotine-dependence severity, withdrawal, population membership, baseline affective-disorder symptoms, and sociodemographic characteristics.
RESULTS


Dependence severity was negatively associated with both adherence measures at Week 6 (p<0.01), whereas increased satisfaction with study cigarettes and age were positively associated with both measures at Weeks 6 and 12 (p<0.01). Opioid-maintained adults exhibited reduced adherence and were less likely to reach full adherence at Week 12 compared to disadvantaged women (p=0.02).
CONCLUSIONS


Factors associated with VLNC adherence in vulnerable populations are similar to those in the general population of smokers. Further studies are indicated investigating nicotine supplements (e.g., e-cigarettes, NRT) to support highly dependent adults faced with using VLNCs.
IMPLICATIONS


This study identified factors predicting difficulty maintaining adherence to a regimen of very low nicotine content cigarettes (VLNC) among adults from vulnerable populations. Findings suggested that factors predicting difficulty maintaining adherence (greater nicotine dependence and low satisfaction with study-provided VLNC) were common across vulnerable smokers and the general population of adults who smoke. Further research should investigate alternatives to support highly dependent adults, such as pairing VLNC with supplemental, non-combusted nicotine. Some vulnerable populations (e.g., opioid-maintained adults) may be especially in need of supplemental, non-combusted nicotine.",2022,"Opioid-maintained adults exhibited reduced adherence and were less likely to reach full adherence at Week 12 compared to disadvantaged women (p=0.02).
","['Data came from three populations of vulnerable adult smokers assigned to use', 'adults from vulnerable populations', 'Vulnerable Populations of Adults Assigned to Smoke Very Low Nicotine Content Cigarettes', 'n=286): socioeconomically disadvantaged women of reproductive age, opioid-maintained adults, and adults with affective disorders']","['low nicotine content cigarettes (VLNC', 'low nicotine content cigarettes (VLNCs', 'VLNC cigarettes (0.4\xa0mg/g nicotine']","['satisfaction with study cigarettes, craving, nicotine-dependence severity, withdrawal, population membership, baseline affective-disorder symptoms, and sociodemographic characteristics']","[{'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1562367', 'cui_str': 'Vulnerable adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0988348,"Opioid-maintained adults exhibited reduced adherence and were less likely to reach full adherence at Week 12 compared to disadvantaged women (p=0.02).
","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Snell', 'Affiliation': 'Brown University, Providence, RI.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Reed', 'Affiliation': 'Brown University, Providence, RI.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tidey', 'Affiliation': 'Brown University, Providence, RI.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Bunn', 'Affiliation': 'University of Vermont, Burlington, VT.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Harfmann', 'Affiliation': 'University of Vermont, Burlington, VT.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'University of Vermont, Burlington, VT.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'University of Vermont, Burlington, VT.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gaalema', 'Affiliation': 'University of Vermont, Burlington, VT.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'University of Vermont, Burlington, VT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntac145']
1955,35183780,Soft Denture liner and microbial disinfection with contemporary and conventional agents.,"AIM


The present study aimed to assess the effect of PDT, herbal and chemical disinfectants on the dental pathogen adherence to soft denture liner colonized with E. coli, C. Albicans, S.aureus, and S. mutans.
MATERIAL AND METHODS


A total of 20 samples of soft-lined removable acrylic complete dentures were fabricated and subjected to the American Type Culture Collection (ATCC) for the inoculation of E.coli, C.albicans, S.mutans and S.aureus in an in-vitro setup. The samples were then randomly divided into four groups and immersed in group 1: 5 µm of Rose Bengal (RB), group 2: Neem extract, group 3: Tea tree oil (TTO), and group 4: 0.12% CHX solutions respectively. Statistical analysis was accomplished by the SPSS 10 statistical software for Windows at a significance level p< 0.05. Two-way ANOVA and Tukey's multiple comparison test were used to analyze the data and compare the means and standard deviation values of CFU/mL (log10) for exposed E. coli, C. albicans, S aureus, and S. mutans.
RESULTS


Intragroup comparison indicated E.coli and C.albicans did not unveil a decrease in reduction CFU/mL (log10) when SDL irradiated with RB 5 µm. Whereas, CFU/mL (log10) values of S.aureus; 2.62±0.68 CFU/mL and S.mutans: 3.41±0.13 CFU/mL plunged significantly (p<0.05). Likewise, S. aureus and S. mutans CFU/mL (log10) strain values display reduction when treated with all four disinfectants while the count of C.albicans unveiled a significant plunge with CHX, TTO and neem extract except RB (p<0.05) CONCLUSION: 0.12% CHX and TTO have enhanced antimicrobial efficacy in reducing adhered bacterial colonies of E.coli, C.albicans, S.aureus, and S.mutans (CFU)/mL on a denture soft liner.",2022,"0.12% CHX and TTO have enhanced antimicrobial efficacy in reducing adhered bacterial colonies of E.coli, C.albicans, S.aureus, and S.mutans (CFU)/mL on a denture soft liner.",['A total of 20 samples of soft-lined removable acrylic complete dentures'],"['PDT, herbal and chemical disinfectants', '5\xa0µm of Rose Bengal (RB), group 2: Neem extract, group 3: Tea tree oil (TTO), and group 4: 0.12% CHX solutions respectively', 'Soft Denture liner and microbial disinfection with contemporary and conventional agents']","['reduction CFU/mL', 'antimicrobial efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0444826', 'cui_str': 'Bengal'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C2347335', 'cui_str': 'Azadirachta indica flower extract'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0216194', 'cui_str': 'Tea Tree Oil'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0011450', 'cui_str': 'Cushion Liners'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439361', 'cui_str': 'cfu/mL'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0366336,"0.12% CHX and TTO have enhanced antimicrobial efficacy in reducing adhered bacterial colonies of E.coli, C.albicans, S.aureus, and S.mutans (CFU)/mL on a denture soft liner.","[{'ForeName': 'Eman M', 'Initials': 'EM', 'LastName': 'AlHamdan', 'Affiliation': 'Prosthetic Dental Science Department, College Of Dentistry, King Saud University Riyadh, Saudi Arabia. Electronic address: ealhamdan@ksu.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2022.102768']
1956,35346534,"Predictors of therapeutic alliance, treatment feedback, and clinical outcomes among African American women in treatment for co-occurring PTSD and SUD.","INTRODUCTION


Black women are at heightened risk for trauma exposure, post-traumatic stress disorder (PTSD), and substance use disorders (SUDs), compared to White women and the general population. However, disparities in treatment engagement and retention persist, particularly for Black women with co-occurring PTSD+SUD. Although therapeutic alliance is an important predictor and mediator of treatment retention and outcomes, we know little about predictors of alliance and the mediating role of alliance for PTSD+SUD outcomes among Black women.
METHODS


This study utilized data previously collected for the National Drug Abuse Treatment Clinical Trials Network (CTN) Women and Trauma Study. Participants were 88 Black/African American women (M age  = 41.90, SD = 7.72) participating in a clinical trial comparing Seeking Safety (a cognitive-behavioral intervention for PTSD+SUD) to Women's Health Education (control). This study includes participants from both arms. Measures included the Helping Alliance Questionnaire, Addiction Severity Index-Lite, and Clinician Administered PTSD Scale. Women in the intervention arm also completed the Seeking Safety Feedback Questionnaire.
RESULTS


Stepwise, hierarchical linear regressions indicated that years of education and previous alcohol/drug treatment attempts significantly predicted early alliance in the second week of therapy (β = 0.411, p = .021 and β = 0.383, p = .011, respectively), but not late alliance in the last week of therapy (ps > .794). Greater education and more treatment attempts were associated with higher early alliance. Alliance did not mediate relationships between these significant predictors and treatment outcomes (e.g., attendance, post-treatment PTSD and SUD symptoms) or treatment feedback in the Seeking Safety group.
CONCLUSIONS


Education and prior treatment attempts predicted early alliance among Black/African American women in PTSD+SUD group treatment, and higher education level was associated with poorer Seeking Safety feedback topic ratings. Educational level and treatment history should be considered during alliance building in therapeutic interventions with Black women. Clinicians may consider the integration of pre-treatment alliance-building strategies with Black female patients who have lower levels of education. This study provides insight into the relative impact of several important factors that influence early alliance among Black women with co-occurring PTSD+SUD.",2022,Greater education and more treatment attempts were associated with higher early alliance.,"[""Participants were 88 Black/African American women (M age \xa0=\xa041.90, SD\xa0=\xa07.72) participating in a clinical trial comparing Seeking Safety (a cognitive-behavioral intervention for PTSD+SUD) to Women's Health Education (control"", 'Black women', 'participants from both arms', 'Black female patients who have lower levels of education', 'Black women with co-occurring PTSD+SUD', 'African American women in treatment for co-occurring PTSD and SUD']",[],"['Seeking Safety Feedback Questionnaire', 'Helping Alliance Questionnaire, Addiction Severity Index-Lite, and Clinician Administered PTSD Scale']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",88.0,0.0226083,Greater education and more treatment attempts were associated with higher early alliance.,"[{'ForeName': 'Alexandria G', 'Initials': 'AG', 'LastName': 'Bauer', 'Affiliation': 'Center of Alcohol & Substance Use Studies, Rutgers University-New Brunswick, United States of America. Electronic address: alexandria.bauer@rutgers.edu.'}, {'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'Center of Alcohol & Substance Use Studies, Rutgers University-New Brunswick, United States of America; Department of Psychology, The City College of New York, United States of America.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Shevorykin', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, United States of America.'}, {'ForeName': 'Tanya C', 'Initials': 'TC', 'LastName': 'Saraiya', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, United States of America.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychology, The City College of New York, United States of America.'}, {'ForeName': 'Kechna', 'Initials': 'K', 'LastName': 'Cadet', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, United States of America.'}, {'ForeName': 'Lovelyne', 'Initials': 'L', 'LastName': 'Julien', 'Affiliation': 'Department of Psychology, New School for Social Research, United States of America.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hien', 'Affiliation': 'Center of Alcohol & Substance Use Studies, Rutgers University-New Brunswick, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2022.108766']
1957,35704630,Clinical impact of statin intensity according to age in patients with acute myocardial infarction.,"BACKGROUND


The available data are not sufficient to understand the clinical impact of statin intensity in elderly patients who undergo percutaneous coronary intervention (PCI) due to acute myocardial infarction (AMI).
METHODS


Using the COREA-AMI registry, we sought to compare the clinical impact of high- versus low-to-moderate-intensity statin in younger (<75 years old) and elderly (≥75 years old) patients. Of 10,719 patients, we included 8,096 patients treated with drug-eluting stents. All patients were classified into high-intensity versus low-to-moderate-intensity statin group according to statin type and dose at discharge. The primary end point was target-vessel failure (TVF), a composite of cardiovascular death, target-vessel MI, or target-lesion revascularization (TLR) from 1 month to 12 months after index PCI.
RESULTS


In younger patients, high-intensity statin showed the better clinical outcomes than low-to-moderate-intensity statin (TVF: 79 [5.4%] vs. 329 [6.8%], adjusted hazard ratio [aHR] 0.76; 95% confidence interval [CI] 0.59-0.99; P = 0.038). However, in elderly patients, the incidence rates of the adverse clinical outcomes were similar between two statin-intensity groups (TVF: 38 [11.4%] vs. 131 [10.6%], aHR 1.1; 95% CI 0.76-1.59; P = 0.63).
CONCLUSIONS


In this AMI cohort underwent PCI, high-intensity statin showed the better 1-year clinical outcomes than low-to-moderate-intensity statin in younger patients. Meanwhile, the incidence rates of adverse clinical events between high- and low-to-moderate-intensity statin were not statistically different in elderly patients. Further randomized study with large elderly population is warranted.",2022,"In younger patients, high-intensity statin showed the better clinical outcomes than low-to-moderate-intensity statin (TVF: 79 [5.4%] vs. 329 [6.8%], adjusted hazard ratio [aHR] 0.76; 95% confidence interval [CI] 0.59-0.99; P = 0.038).","['younger patients', 'elderly patients', 'patients with acute myocardial infarction', 'younger (<75 years old) and elderly (≥75 years old) patients', 'elderly patients who undergo percutaneous coronary intervention (PCI) due to acute myocardial infarction (AMI', '10,719 patients, we included 8,096 patients treated with drug-eluting stents', 'All patients were classified into high-intensity versus low-to-moderate-intensity statin group according to statin type and dose at discharge']",['high- versus low-to-moderate-intensity statin'],"['target-vessel failure (TVF), a composite of cardiovascular death, target-vessel MI, or target-lesion revascularization (TLR', 'incidence rates of adverse clinical events', 'incidence rates of the adverse clinical outcomes', '1-year clinical outcomes']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}]",8096.0,0.0340094,"In younger patients, high-intensity statin showed the better clinical outcomes than low-to-moderate-intensity statin (TVF: 79 [5.4%] vs. 329 [6.8%], adjusted hazard ratio [aHR] 0.76; 95% confidence interval [CI] 0.59-0.99; P = 0.038).","[{'ForeName': 'Kyusup', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Myunhee', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Dae-Won', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jinseob', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Epidemiology, School of Public Health, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Sungmin', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Ho', 'Initials': 'EH', 'LastName': 'Choo', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Chan Joon', 'Initials': 'CJ', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Chul Soo', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Yeol', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Dong', 'Initials': 'KD', 'LastName': 'Yoo', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Doo Soo', 'Initials': 'DS', 'LastName': 'Jeon', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Kiyuk', 'Initials': 'K', 'LastName': 'Chang', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Ho Joong', 'Initials': 'HJ', 'LastName': 'Youn', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Wook-Sung', 'Initials': 'WS', 'LastName': 'Chung', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Min Chul', 'Initials': 'MC', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Center, Chonnam National University Hospital, Chonnam National University, Gwangju, Republic of Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Cardiovascular Center, Chonnam National University Hospital, Chonnam National University, Gwangju, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Ahn', 'Affiliation': 'Cardiovascular Center, Chonnam National University Hospital, Chonnam National University, Gwangju, Republic of Korea.'}, {'ForeName': 'Jongbum', 'Initials': 'J', 'LastName': 'Kwon', 'Affiliation': ""Department of Thoracic and Cardiovascular Surgery, Daejeon St. Mary's Hospital, the Catholic University of Korea, Daejeon, Republic of Korea.""}, {'ForeName': 'Mahn-Won', 'Initials': 'MW', 'LastName': 'Park', 'Affiliation': 'Cardiovascular Research Institute for Intractable Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0269301']
1958,35704616,Stimulation of the tibial nerve-a randomised trial for urinary problems associated with Parkinson's-the STARTUP trial.,"BACKGROUND


non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson's increasing the risk for falls with a negative impact on health-related costs and quality of life.We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson's disease (PD).Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device.The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed.
RESULTS


two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25). There was no statistically significant change in any other outcome.
CONCLUSION


TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.",2022,"Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25).","['two hundred forty two participants were randomised', ""people with Parkinson's disease"", 'About 59% of participants were male, the mean age was 69\xa0years and mean time since diagnosis was 6\xa0years']","['transcutaneous tibial nerve stimulation (TTNS', 'TTNS']","['Questionnaire return rate', 'International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C4544471', 'cui_str': 'International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}]",242.0,0.459935,"Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25).","[{'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'NMAHP RU, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'NMAHP RU, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'NMAHP RU, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mason', 'Affiliation': 'Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Booth', 'Affiliation': 'Scholl of Health & Life Sciences, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Anne-Louise', 'Initials': 'AL', 'LastName': 'Cunnington', 'Affiliation': 'The New Stobhill Hospital - NHSGGC, G21 3UW.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, NE25 0QJ.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Deane', 'Affiliation': 'School of Nursing Sciences, University of East Anglia, NR4 7TJ, Norwich.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Harari', 'Affiliation': ""Guy's & St Thomas Hospital NHS Foundation Trust, SE1 7EH, London.""}, {'ForeName': 'Jalesh', 'Initials': 'J', 'LastName': 'Panicker', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, WC1E 6BT, London.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stratton', 'Affiliation': 'NMAHP RU, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'McArthur', 'Affiliation': 'Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Sellers', 'Affiliation': 'NMAHP RU, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Collins', 'Affiliation': 'Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}]",Age and ageing,['10.1093/ageing/afac114']
1959,35704597,"Sex-specific effects of daily tadalafil on diabetic heart kinetics in RECOGITO, a randomized, double-blind, placebo-controlled trial.","Cyclic GMP-phosphodiesterase type 5 (PDE5) inhibition has been shown to counteract maladaptive cardiac changes triggered by diabetes in some but not all studies. We performed a single-center, 20-week, double-blind, randomized, placebo-controlled trial (NCT01803828) to assess sex differences in cardiac remodeling after PDE5 inhibition in patients with diabetic cardiomyopathy. A total of 122 men and women (45 to 80 years) with long-duration (>3 years) and well-controlled type 2 diabetes mellitus (T2DM; HbA1c < 86 mmol/mol) were selected according to echocardiographic signs of cardiac remodeling. Patients were randomly assigned (1:1) to placebo or oral tadalafil (20 mg, once daily). The primary outcome was to evaluate sex differences in cardiac torsion change. Secondary outcomes were changes in cardiovascular, metabolic, immune, and renal function. At 20 weeks, the treatment-by-sex interaction documented an improvement in cardiac torsion (-3.40°, -5.96; -0.84,  P  = 0.011) and fiber shortening (-1.19%, -2.24; -0.14,  P  = 0.027) in men but not women. The primary outcome could not be explained by differences in cGMP concentrations or tadalafil pharmacodynamics. In both sexes, tadalafil improved hsa-miR-199-5p expression, biomarkers of cardiovascular remodeling, albuminuria, renal artery resistive index, and circulating Klotho concentrations. Immune cell profiling revealed an improvement in low-grade chronic inflammation: Classic CD14 ++ CD16 -  monocytes reduced, and Tie2 +  monocytes increased. Nine patients (14.5%) had minor adverse reactions after tadalafil administration. Continuous PDE5 inhibition could offer a strategy to target cardiorenal complications of T2DM, with sex- and tissue-specific responses. Further studies are needed to confirm Klotho and hsa-miR-199-5p as markers for T2DM complications.",2022,"In both sexes, tadalafil improved hsa-miR-199-5p expression, biomarkers of cardiovascular remodeling, albuminuria, renal artery resistive index, and circulating Klotho concentrations.","['patients with diabetic cardiomyopathy', '122 men and women (45 to 80 years) with long-duration (>3 years) and well-controlled type 2 diabetes mellitus (T2DM; HbA1c < 86 mmol/mol']","['tadalafil', 'Cyclic GMP-phosphodiesterase type 5 (PDE5) inhibition', 'placebo or oral tadalafil', 'placebo']","['cGMP concentrations or tadalafil pharmacodynamics', 'adverse reactions', 'cardiac torsion change', 'fiber shortening', 'tadalafil improved hsa-miR-199-5p expression, biomarkers of cardiovascular remodeling, albuminuria, renal artery resistive index, and circulating Klotho concentrations', 'diabetic heart kinetics', 'changes in cardiovascular, metabolic, immune, and renal function', 'cardiac torsion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853897', 'cui_str': 'Diabetic cardiomyopathy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0757672', 'cui_str': 'Phosphodiesterase 5'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018763', 'cui_str': 'Health Systems Agencies'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",122.0,0.453142,"In both sexes, tadalafil improved hsa-miR-199-5p expression, biomarkers of cardiovascular remodeling, albuminuria, renal artery resistive index, and circulating Klotho concentrations.","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pofi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Giannetta', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Feola', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Galea', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barbagallo', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Campolo', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Badagliacca', 'Affiliation': 'Department of Cardiovascular and Respiratory Diseases, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Barbano', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Ciolina', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Defeudis', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico di Roma, 00161 Rome, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Filardi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Sesti', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Minnetti', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Carmine D', 'Initials': 'CD', 'LastName': 'Vizza', 'Affiliation': 'Department of Cardiovascular and Respiratory Diseases, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Patrizio', 'Initials': 'P', 'LastName': 'Pasqualetti', 'Affiliation': 'Medical Statistics and Information Technology, AFaR, Fatebenefratelli Hospital, 00161 Rome, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Caboni', 'Affiliation': 'Department of Life and Environmental Sciences, University of Cagliari, 09124 Cagliari, Italy.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Carbone', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Francone', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Catalano', 'Affiliation': 'Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pozzilli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico di Roma, 00161 Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lenzi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Mary Anna', 'Initials': 'MA', 'LastName': 'Venneri', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Gianfrilli', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Isidori', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, 00161 Rome, Italy.'}]",Science translational medicine,['10.1126/scitranslmed.abl8503']
1960,35704592,Misleading graphs in context: Less misleading than expected.,"Misleading graphs are a source of misinformation that worry many experts. Especially people with a low graph literacy are thought to be persuaded by graphs that misrepresent the underlying data. But we know little about how people interpret misleading graphs and how these graphs influence their opinions. In this study we focus on the effect of truncating the y-axis for a line chart which exaggerates an upgoing trend. In a randomized controlled trial, we showed participants either a normal or a misleading chart, and we did so in two different contexts. After they had seen the graphs, we asked participants their opinion on the trend and to give an estimation of the increase. Finally we measured their graph literacy. Our results show that context is the only significant factor in opinion-forming; the misleading graph and graph literacy had no effect. None of these factors had a significant impact on estimations for the increase. These results show that people might be less susceptible to misleading graphs than we thought and that context has more impact than a misleading y-axis.",2022,Our results show that context is the only significant factor in opinion-forming; the misleading graph and graph literacy had no effect.,"['participants either a normal or a misleading chart, and we did so in two different contexts']",[],[],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449255', 'cui_str': 'Context'}]",[],[],,0.0693606,Our results show that context is the only significant factor in opinion-forming; the misleading graph and graph literacy had no effect.,"[{'ForeName': 'Jannetje E P', 'Initials': 'JEP', 'LastName': 'Driessen', 'Affiliation': 'Science Communication and Society, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Daniël A C', 'Initials': 'DAC', 'LastName': 'Vos', 'Affiliation': 'Department of Psychology, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Ionica', 'Initials': 'I', 'LastName': 'Smeets', 'Affiliation': 'Science Communication and Society, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Casper J', 'Initials': 'CJ', 'LastName': 'Albers', 'Affiliation': 'Department of Psychology, University of Groningen, Groningen, Netherlands.'}]",PloS one,['10.1371/journal.pone.0265823']
1961,35704561,Can dogs reduce stress levels in school children? effects of dog-assisted interventions on salivary cortisol in children with and without special educational needs using randomized controlled trials.,"Prolonged or excessive stress negatively affects learning, behavior and health across the lifespan. To alleviate adverse effects of stress in school children, stressors should be reduced, and support and effective interventions provided. Animal-assisted interventions (AAI) have shown beneficial effects on health and wellbeing, however, robust knowledge on stress mediation in children is lacking. Despite this, AAIs are increasingly employed in settings world-wide, including schools, to reduce stress and support learning and wellbeing. This study is the first randomized controlled trial to investigate dog-assisted interventions as a mediator of stress in school children with and without special educational needs (SEN) over the school term. Interventions were carried out individually and in small groups twice a week for 20 minutes over the course of 4 weeks. We compared physiological changes in salivary cortisol in a dog intervention group with a relaxation intervention group and a no treatment control group. We compared cortisol level means before and after the 4 weeks of interventions in all children as well as acute cortisol in mainstream school children. Dog interventions lead to significantly lower stress in children with and without special educational needs compared to their peers in relaxation or no treatment control groups. In neurotypical children, those in the dog interventions showed no baseline stress level increases over the school term. In addition, acute cortisol levels evidenced significant stress reduction following the interventions. In contrast, the no treatment control group showed significant rises in baseline cortisol levels from beginning to end of school term. Increases also occurred in the relaxation intervention group. Children with SEN showed significantly decreased cortisol levels after dog group interventions. No changes occurred in the relaxation or no treatment control groups. These findings provide crucial evidence that dog interventions can successfully attenuate stress levels in school children with important implications for AAI implementation, learning and wellbeing.",2022,Dog interventions lead to significantly lower stress in children with and without special educational needs compared to their peers in relaxation or no treatment control groups.,"['school children', 'children with and without special educational needs', 'mainstream school children', 'school children with and without special educational needs (SEN) over the school term']","['dog-assisted interventions', 'relaxation intervention', 'Animal-assisted interventions (AAI']","['baseline cortisol levels', 'learning, behavior and health across the lifespan', 'cortisol levels', 'stress levels', 'salivary cortisol', 'baseline stress level']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0589339', 'cui_str': 'Mainstream school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0373396,Dog interventions lead to significantly lower stress in children with and without special educational needs compared to their peers in relaxation or no treatment control groups.,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Meints', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, Lincolnshire, United Kingdom.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Brelsford', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, Lincolnshire, United Kingdom.'}, {'ForeName': 'Mirena', 'Initials': 'M', 'LastName': 'Dimolareva', 'Affiliation': 'Department of Psychology, School of Science, Bath Spa University, Bath, Somerset, United Kingdom.'}, {'ForeName': 'Laëtitia', 'Initials': 'L', 'LastName': 'Maréchal', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, Lincolnshire, United Kingdom.'}, {'ForeName': 'Kyla', 'Initials': 'K', 'LastName': 'Pennington', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, Lincolnshire, United Kingdom.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Rowan', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, Lincolnshire, United Kingdom.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Gee', 'Affiliation': 'Center for Human-Animal Interaction, School of Medicine, Virginia Commonwealth University, Richmond, VA, United States of America.'}]",PloS one,['10.1371/journal.pone.0269333']
1962,35704559,Adherence to additional medication for management of HIV-associated comorbidities among older children and adolescents taking antiretroviral therapy.,"BACKGROUND


Management of co-morbidities among persons living with HIV is an emerging priority, which may require additional medication over and above life-long antiretroviral therapy (ART). We explored factors associated with adherence to the trial drug among children and adolescents with perinatally acquired HIV taking antiretroviral therapy (ART) in the Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-Infected Children (BREATHE) trial.
METHODS


The BREATHE trial recruited 6-19 year olds with perinatally acquired HIV and co-morbid chronic lung disease as measured by FEV1. This two-site trial was individually randomised (1:1), double-blind and placebo-controlled. Participants received a once-weekly weight-based dose of 1-5 tablets of azithromycin (AZM: 250mg) or placebo, taken orally. We used pharmacy dispensing records and count of returned pills to measure adherence to study medication. Logistic regression was used to explore factors associated with adherence coverage. Poisson regression with Lexis expansion for time was used to explore whether adherence modified the effect of azithromycin on the incidence of acute respiratory exacerbation, a secondary outcome of the trial. Trial registration: ClinicalTrials.gov NCT02426112.
RESULTS


The 347 participants (median age 15.3, 51% male) consumed 14,622 doses of study medication over 16,220 person-weeks under study. Adherence was higher for those randomised to AZM (73.4%) than placebo (68.4%) and declined over the 48 weeks of the study (Score test for trend <0.02). Those with unsuppressed HIV viral load at baseline had 2.08 (95% CI: 1.19, 3.63) times the odds of non-adherence than those with viral suppression. Differences were also observed between trial sites.
CONCLUSION


The majority of children and adolescents tolerated the addition of a once-weekly dose of medication to their pill burden. Barriers in adhering to treatment for co-morbid conditions are likely common to barriers in adhering to ART. Control of co-morbidities will therefore present additional challenges in HIV care.",2022,Adherence was higher for those randomised to AZM (73.4%) than placebo (68.4%) and declined over the 48 weeks of the study (Score test for trend <0.02).,"['children and adolescents with perinatally acquired HIV taking', 'older children and adolescents taking antiretroviral therapy', 'persons living with HIV', '347 participants (median age 15.3, 51% male) consumed 14,622 doses of study medication over 16,220 person-weeks under study', '6-19 year olds with perinatally acquired HIV and co-morbid chronic lung disease as measured by FEV1']","['azithromycin (AZM: 250mg) or placebo', 'AZM', 'azithromycin', 'Azithromycin', 'placebo', 'antiretroviral therapy (ART']",['Adherence'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.747252,Adherence was higher for those randomised to AZM (73.4%) than placebo (68.4%) and declined over the 48 weeks of the study (Score test for trend <0.02).,"[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Rehman', 'Affiliation': 'MRC International Statistics and Epidemiology Group, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Simms', 'Affiliation': 'MRC International Statistics and Epidemiology Group, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'McHugh', 'Affiliation': 'Biomedical Research and Training Institute, Harare, Zimbabwe.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Mujuru', 'Affiliation': 'Department of Paediatrics, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Lucky G', 'Initials': 'LG', 'LastName': 'Ngwira', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Robina', 'Initials': 'R', 'LastName': 'Semphere', 'Affiliation': 'Department of Microbiology & HNTI, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Brewster', 'Initials': 'B', 'LastName': 'Moyo', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Tsitsi', 'Initials': 'T', 'LastName': 'Bandason', 'Affiliation': 'Biomedical Research and Training Institute, Harare, Zimbabwe.'}, {'ForeName': 'Jon O', 'Initials': 'JO', 'LastName': 'Odland', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science & Technology, Trondheim, Norway.'}, {'ForeName': 'Rashida A', 'Initials': 'RA', 'LastName': 'Ferrand', 'Affiliation': 'Biomedical Research and Training Institute, Harare, Zimbabwe.'}]",PloS one,['10.1371/journal.pone.0269229']
1963,35701033,Stress ulcer prophylaxis for critically ill children: routine use needs to be re-examined.,"INTRODUCTION


Stress ulcer prophylaxis (SUP) is commonly used in Paediatric Intensive Care Units (PICUs). However, strong evidence for this practice is lacking and there is a dire need for paediatric randomized controlled trials (RCTs). Our aim was to assess the usefulness of SUP with omeprazole in critically ill children.
PATIENTS AND METHODS


We conducted a randomized, controlled open-label trial, including 144 children admitted into a PICU with a paediatric Sequential Organ Failure Assessment (pSOFA) score of less than 16. We randomly allocated patients to SUP with omeprazole or no SUP. The primary outcome was development of upper gastrointestinal bleeding or nosocomial infection.
RESULTS


The incidence of gastrointestinal bleeding was 27.1%, but clinically significant bleeding developed in only 5.6% of patients. We did not find a significant difference in the incidence of bleeding between the prophylaxis and control groups (27.8% vs 26.4%; P = .85). We also did not find a significant difference between the groups in the incidence of ventilator-associated pneumonia (VAP) (9.6% vs 8.3%; P = .77). The incidence of central line-associated bloodstream infection (CLABSI) was higher in the prophylaxis group compared to the control group (30.6% vs 12.5%; P = .014). None of the patients developed Clostridium difficile-associated diarrhoea. We did not find significant differences in mortality, length of PICU stay or duration of mechanical ventilation. Mechanical ventilation was an independent predictor of bleeding (OR, 6.4; 95%CI, 2.73-14.9).
CONCLUSION


In PICU patients with mild to moderate organ dysfunction, omeprazole does not seem to be useful for prevention of gastrointestinal bleeding while at the same time increasing the risk of CLABSI. Thus, we recommend restricting SUP to mechanically ventilated children.",2022,"Mechanical ventilation was an independent predictor of bleeding (OR, 6.4; 95%CI, 2.73-14.9).
","['critically ill children', 'mechanically ventilated children', '144 children admitted into a PICU with a paediatric Sequential Organ Failure Assessment (pSOFA) score of less than 16']","['Stress ulcer prophylaxis (SUP', 'omeprazole', 'SUP with omeprazole or no SUP', 'SUP with omeprazole', 'Mechanical ventilation']","['incidence of central line-associated bloodstream infection (CLABSI', 'incidence of ventilator-associated pneumonia (VAP', 'development of upper gastrointestinal bleeding or nosocomial infection', 'incidence of gastrointestinal bleeding', 'incidence of bleeding', 'Clostridium difficile-associated diarrhoea', 'mortality, length of PICU stay or duration of mechanical ventilation']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0400807', 'cui_str': 'Stress ulcer of stomach'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",144.0,0.087752,"Mechanical ventilation was an independent predictor of bleeding (OR, 6.4; 95%CI, 2.73-14.9).
","[{'ForeName': 'Sohair Sayed', 'Initials': 'SS', 'LastName': 'Abu El-Ella', 'Affiliation': 'Departamento de Pediatría, Facultad de Medicina, Universidad de Menufia, Shibin el-Kom, Egypt.'}, {'ForeName': 'Muhammad Said', 'Initials': 'MS', 'LastName': 'El-Mekkawy', 'Affiliation': 'Departamento de Pediatría, Facultad de Medicina, Universidad de Menufia, Shibin el-Kom, Egypt. Electronic address: mohamed.elmakawi@med.menofia.edu.eg.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohamed Selim', 'Affiliation': 'Departamento de Pediatría, Facultad de Medicina, Universidad de Menufia, Shibin el-Kom, Egypt.'}]",Anales de pediatria,['10.1016/j.anpede.2021.03.001']
1964,35701011,Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2.,"OBJECTIVES


Determine the impact of 24-week risankizumab (RZB) versus placebo (PBO) on patient-reported outcomes (PROs) in patients with psoriatic arthritis (PsA) and inadequate response to one or two biologics (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR).
METHODS


Patients in the Phase 3 trial, KEEPsAKE 2, were randomised (1:1) to RZB 150 mg or PBO by subcutaneous injection. PROs assessed: 36-Item Short-Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Patient's Assessment of Pain by visual analogue scale (VAS), Patient's global assessment of disease activity (PtGA), EuroQoL-5 Dimension-5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment-PsA (WPAI-PsA). Least squares mean change from baseline at week 24 was compared between RZB versus PBO by mixed-effects repeated regression modelling.
RESULTS


At week 24, RZB versus PBO treatment resulted in significant differences (95% CIs) in mean change from baseline in ranked secondary endpoints SF-36 physical component summary score (3.9 (2.4 to 5.3); p<0.001) and FACIT-Fatigue (2.2 (0.6 to 3.9); p=0.009) and improvements in pain (-8.1 (-12.8 to -3.5)), PtGA (-8.8 (-13.5 to -4.2)) and EQ-5D-5L index (0.08 (0.04 to 0.11)) and VAS (5.9 (1.9 to 9.8)) (all nominal p<0.01). More RZB-treated versus PBO-treated patients reported improvements from baseline at week 24 in 7 of 8 SF-36 subdomains (nominal p<0.05). At week 24, more RZB-treated versus PBO-treated patients reported improvements in 3 of 4 WPAI-PsA domains (nominal p≤0.01).
CONCLUSION


Overall, RBZ treatment resulted in improvements in pain, fatigue, health-related quality of life and ability to perform work in Bio-IR and/or csDMARD-IR patients with PsA.
TRIAL REGISTRATION NUMBER


NCT03671148.",2022,"Overall, RBZ treatment resulted in improvements in pain, fatigue, health-related quality of life and ability to perform work in Bio-IR and/or csDMARD-IR patients with PsA.
","['patients with psoriatic arthritis (PsA) and inadequate response to one or two biologics (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR', 'patients with psoriatic arthritis treated with', 'Patients in the Phase 3 trial, KEEPsAKE 2']","['risankizumab', 'RZB 150\u2009mg or PBO', 'risankizumab (RZB) versus placebo (PBO', 'RBZ']","['PROs assessed: 36-Item Short-Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue', 'pain', 'FACIT-Fatigue', 'EQ-5D-5L index', 'SF-36 physical component summary score', 'pain, fatigue, health-related quality of life and ability to perform work in Bio-IR and/or csDMARD-IR patients with PsA', ""Pain by visual analogue scale (VAS), Patient's global assessment of disease activity (PtGA), EuroQoL-5 Dimension-5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment-PsA (WPAI-PsA"", 'PtGA', 'VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206788', 'cui_str': 'zorubicin'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.303929,"Overall, RBZ treatment resulted in improvements in pain, fatigue, health-related quality of life and ability to perform work in Bio-IR and/or csDMARD-IR patients with PsA.
","[{'ForeName': 'Andrew J K', 'Initials': 'AJK', 'LastName': 'Ostor', 'Affiliation': 'Cabrini Hospital, Monash University & Emeritus Research, Melbourne, Victoria, Australia andrewostor@gmail.com.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Padilla', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Zailong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Eldred', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'de Vlam', 'Affiliation': 'Department of Rheumatology, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.'}]",RMD open,['10.1136/rmdopen-2022-002286']
1965,35700976,Lifting Velocity as a Predictor of the Maximum Number of Repetitions That Can Be Performed to Failure During the Prone Bench Pull Exercise.,"OBJECTIVE


To explore (1) the goodness of fit of generalized and individualized relationships between the maximum number of repetitions performed to failure (RTF) and the fastest mean velocity and peak velocity of the sets (RTF-velocity relationships), (2) the between-sessions reliability of mean velocity and peak velocity values associated with different RTFs, and (3) whether the errors in the prediction of the RTF under fatigued and nonfatigued conditions differ between generalized and individualized RTF-velocity relationships.
METHODS


Twenty-three sport-science students performed 4 testing sessions with the prone bench pull exercise in a Smith machine: a 1-repetition-maximum [1RM] session, 2 identical sessions consisting of singles sets of RTF against 4 randomized loads (60%-70%-80%-90%1RM), and 1 session consisting of 4 sets of RTF against the 75%1RM.
RESULTS


Individualized RTF-velocity relationships presented a higher goodness of fit (r2 = .96-.97 vs .67-.70) and accuracy (absolute errors = 2.1-2.9 repetitions vs 2.8-4.3 repetitions) in the prediction of the RTF than generalized RTF-velocity relationships. The reliability of the velocity values associated with different RTFs was generally high (average within-subject coefficient of variation = 4.01% for mean velocity and 3.98% for peak velocity). The error in the prediction of the RTF increased by ~1 repetition under fatigue (ie, set 1 vs sets 2-4).
CONCLUSIONS


Individualized RTF-velocity relationships can be used with acceptable precision and reliability to prescribe the loads associated with a given RTF during the match a specific XRM during the prone bench pull exercise, but a lower accuracy is expected in a fatigued state.",2022,"RESULTS


Individualized RTF-velocity relationships presented a higher goodness of fit (r2 = .96-.97 vs .67-.70) and accuracy (absolute errors = 2.1-2.9 repetitions vs 2.8-4.3 repetitions) in the prediction of the RTF than generalized RTF-velocity relationships.",['Twenty-three sport-science students performed 4'],"['RTF against 4 randomized loads (60%-70%-80%-90%1RM), and 1 session consisting of 4 sets of RTF against the 75%1RM', 'testing sessions with the prone bench pull exercise in a Smith machine: a 1-repetition-maximum [1RM] session']","['mean velocity and peak velocity of the sets (RTF-velocity relationships), (2) the between-sessions reliability of mean velocity and peak velocity values']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0553062,"RESULTS


Individualized RTF-velocity relationships presented a higher goodness of fit (r2 = .96-.97 vs .67-.70) and accuracy (absolute errors = 2.1-2.9 repetitions vs 2.8-4.3 repetitions) in the prediction of the RTF than generalized RTF-velocity relationships.","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Miras-Moreno', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada,Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez-Castilla', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada,Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada,Spain.'}]",International journal of sports physiology and performance,['10.1123/ijspp.2021-0534']
1966,35700959,"A Commentary on ""Preoperative carbohydrate loading with individualized supplemental insulin in diabetic patients undergoing gastrointestinal surgery: A randomized trial"" (Int J Surg 2022;98:106215).",,2022,,['diabetic patients undergoing gastrointestinal surgery'],[],[],"[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}]",[],[],,0.115514,,"[{'ForeName': 'Fanghui', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Department of Endocrinology, Sanhe Yanjiao Fuhe First Hospital, Hebei, 065201, China.'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Emergency Medicine, Hebei Yanda Hospital, Hebei, 065201, China. Electronic address: xhd243z@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2022.106690']
1967,35700837,Circulating total and intact GDF-15 levels are not altered in response to weight loss induced by liraglutide or lorcaserin treatment in humans with obesity.,"BACKGROUND


Growth differentiation factor 15 (GDF-15) is a stress-response cytokine proposed to be associated with body weight regulation.
AIMS


The primary aim was to investigate changes of circulating intact GDF-15 (wildtype, non-carrier of the rs1058587 polymorphism coding for the H2O2D mutation) and total GDF-15 (measured irrespective of the mutation) in response to liraglutide (GLP-1 receptor agonist) and lorcaserin (5-HT2C receptor agonist), two pharmacologic agents that induce food intake and weight reduction. In addition, we perform exploratory correlations of total and intact GDF-15 with clinical, hormonal and metabolo-lipidomic parameters in humans with obesity.
MATERIALS AND METHODS


We utilized two studies: 1) Study 1, a randomized, double-blinded, cross-over trial of liraglutide and placebo administration for 5 weeks in subjects with obesity (n = 20; BMI = 35.6 ± 5.9 kg/m2), in escalating doses starting at 0.6 mg/day on week 1 and increased every week, up to the highest dose of 3.0 mg/day during week 5. b) Study 2, a randomized, double-blinded trial of lorcaserin 10 mg twice daily, or placebo for 12-weeks in humans with obesity (n = 34 BMI = 37.4 ± 6.1 kg/m2). Total and intact GDF-15 levels were measured with novel enzyme-linked immunosorbent assays and the metabolomics and lipidomics analysis was performed with nuclear magnetic resonance spectroscopy.
RESULTS


Total and intact GDF-15 were positively correlated with diabetes risk index and trimethylamine N-oxide and negatively with eGFR. Despite significant changes in body weight, total and intact GDF-15 were not altered in response to liraglutide or lorcaserin treatment in subjects with obesity.
CONCLUSIONS


Total and intact GDF-15 levels are not altered in response to liraglutide or lorcaserin therapy and are thus not directly involved in the metabolic feedback loop pathways downstream of GLP1 or 5-HT2C receptor agonists. Since neither total nor intact GDF-15 levels were altered in response to weight loss, future studies are needed to elucidate the pathways activated by GDF-15 in humans and its role, if any, in body weight regulation and energy homeostasis.",2022,"CONCLUSIONS


Total and intact GDF-15 levels are not altered in response to liraglutide or lorcaserin therapy and are thus not directly involved in the metabolic feedback loop pathways downstream of GLP1 or 5-HT2C receptor agonists.","['subjects with obesity', 'subjects with obesity (n\u202f=\u202f20; BMI\u202f=\u202f35.6\u202f±\u202f5.9\u202fkg/m2', 'humans with obesity']","['liraglutide', 'liraglutide and placebo', 'lorcaserin 10\u202fmg twice daily, or placebo']","['diabetes risk index and trimethylamine N-oxide and negatively with eGFR', 'Circulating total and intact GDF-15 levels', 'body weight, total and intact GDF-15', 'Total and intact GDF-15 levels', 'Total and intact GDF-15', 'circulating intact GDF-15 (wildtype, non-carrier of the rs1058587 polymorphism coding for the H2O2D mutation) and total GDF-15']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.179029,"CONCLUSIONS


Total and intact GDF-15 levels are not altered in response to liraglutide or lorcaserin therapy and are thus not directly involved in the metabolic feedback loop pathways downstream of GLP1 or 5-HT2C receptor agonists.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Valenzuela-Vallejo', 'Affiliation': 'Department of Medicine, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, United States of America.'}, {'ForeName': 'Pavlina', 'Initials': 'P', 'LastName': 'Chrysafi', 'Affiliation': 'Department of Medicine, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, United States of America.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Bello-Ramos', 'Affiliation': 'Department of Medicine, Boston Medical Center, Boston University School of Medicine, Boston, MA 02218, United States of America.'}, {'ForeName': 'Shahd', 'Initials': 'S', 'LastName': 'Bsata', 'Affiliation': 'Department of Medicine, Boston Medical Center, Boston University School of Medicine, Boston, MA 02218, United States of America.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Department of Medicine, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, United States of America; Department of Medicine, Boston Medical Center, Boston University School of Medicine, Boston, MA 02218, United States of America; Department of Medicine, Boston VA Healthcare System, Boston, MA 02130, United States of America. Electronic address: cmantzor@bidmc.harvard.edu.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2022.155237']
1968,35701334,A randomized double-blind single center study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention).,"INTRODUCTION


Elevated luteinizing hormone (LH) in combination with low-normal testosterone (mild Leydig cell insufficiency) is common in testicular cancer (TC) survivors and is associated with impaired insulin sensitivity and metabolic syndrome. The aim was to evaluate if testosterone replacement therapy (TRT) improves metabolic health in this subgroup of TC survivors.
PATIENTS AND METHODS


This was a single-center, double-blind, randomized, controlled trial. The main eligibility criterion was LH above the age-adjusted upper limit of normal in combination with free testosterone in the lower half of the age-adjusted normal range (mild Leydig cell insufficiency) >1 year after TC treatment. Eligible patients were randomly assigned (1:1) to 12 months transdermal TRT (Tostran, gel, 2%) or placebo with a maximum daily dose of 40 mg. The primary outcome was difference in Δ2 hour glucose measured with oral glucose tolerance test between groups assessed at 12 months. Outcomes were assessed after 6-, 12- and 3 months post-treatment. The study was registered at www.
CLINICALTRIAL


gov (NCT02991209) and ended June 2019.
RESULTS


Between October 2016 and February 2018, 140 patients were screened for eligibility and 69 were randomized to testosterone (n = 35, 51%) or placebo (n = 34, 49%). TRT was not associated with a statistically significant difference in Δ2 hour glucose compared to placebo after 12 months of treatment (0.04 mmol/L (95% CI: -0.53, 0.60)). There was no statistically significant difference in Δ2 hour insulin between the groups after 12 months of treatment (28.23 pmol/L (95% CI: -34.40, 90.86)). Similarly, TRT was not associated with significant improvement in components of metabolic syndrome. TRT was associated with a decrease in fat mass after 12 months compared to placebo (-1.35 kg, (95% CI: -2.53, -0.18)).
CONCLUSION


In TC survivors with mild Leydig cell insufficiency, TRT was not associated with improvement of metabolic health. These findings do no not support routine use of TRT in these patients.",2022,"TRT was not associated with a statistically significant difference in Δ2 hour glucose compared to placebo after 12 months of treatment (0.04 mmol/L (95% CI: -0.53, 0.60)).","['Eligible patients', 'Between October 2016 and February 2018, 140 patients were screened for eligibility and 69 were randomized to', 'testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention', 'testicular cancer (TC) survivors', 'in the lower half of the age-adjusted normal range (mild Leydig cell insufficiency']","['Elevated luteinizing hormone (LH) in combination with low-normal testosterone', 'transdermal TRT (Tostran, gel, 2%) or placebo', 'testosterone', 'testosterone replacement therapy or placebo', 'testosterone replacement therapy (TRT', 'free testosterone', 'TRT', 'placebo']","['Δ2 hour glucose measured with oral glucose tolerance test', 'fat mass', 'metabolic health', 'components of metabolic syndrome', 'TRT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0153594', 'cui_str': 'Malignant tumor of testis'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1739394', 'cui_str': 'Leydig cell insufficiency'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}]",140.0,0.763727,"TRT was not associated with a statistically significant difference in Δ2 hour glucose compared to placebo after 12 months of treatment (0.04 mmol/L (95% CI: -0.53, 0.60)).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreiberg', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. Electronic address: michael.kreiberg.jessen@regionh.dk.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet, Copenhagen Denmark; International Center for Research and Research Training in Endocrine Disruption of Male Reproduction and Child Health (EDMaRC) University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Juul', 'Affiliation': 'Department of Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet, Copenhagen Denmark; International Center for Research and Research Training in Endocrine Disruption of Male Reproduction and Child Health (EDMaRC) University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Lauritsen', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oturai', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine and PET, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jørn Wulff', 'Initials': 'JW', 'LastName': 'Helge', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesper Frank', 'Initials': 'JF', 'LastName': 'Christensen', 'Affiliation': 'Centre of Physical Activity Research, Centre of Inflammation and Metabolism, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Aksglaede', 'Affiliation': 'Department of Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet, Copenhagen Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schauer', 'Affiliation': 'Centre of Physical Activity Research, Centre of Inflammation and Metabolism, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wagner', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Rosenvilde', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Grunwald', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dehlendorff', 'Affiliation': 'Statistics and Data analysis, Danish Cancer Society Research Center, Danish Cancer Society, Copenhagen, Denmark.'}, {'ForeName': 'Gedske', 'Initials': 'G', 'LastName': 'Daugaard', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Bandak', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2022.04.017']
1969,35701331,The Effect of Remote-Based Monitoring and Education Program on Cancer Pain Management in an Outpatient Pain Clinic.,"BACKGROUND


Pain is one of the most feared consequences of cancer for patients and their families. Many barriers may hinder optimal pain management.
AIM


Examine the effect of remote-based monitoring and education program on cancer pain management, patient-related barriers, and level of adherence to pain medication.
METHODS


A sample of 134 patients was assigned to two groups; 68 in the intervention group and 66 in the control. The intervention group received three educational sessions by telephone. Both groups completed questionnaires at baseline and one month after the initial visit.
RESULTS


Significant differences were found between the groups in the levels of pain right now (p = .030), pain at its least (p = .016), and in the percentage of achieved pain relief (p = .048). Moreover, the intervention group experienced lower levels of interference with their general activity (p = < .001), mood (p = .011), and normal work (p = .004) post-intervention. The Attitudinal Barriers differences were statistically significant in the total mean (p = < .001), and the subscales of physiological effects (p = < .001), fatalism (p = < .001), communication (p = < .001), harmful effects (p = < .001). Participants in the intervention group exhibited higher adherence levels (p = .001).
CONCLUSIONS


Patients suffering from cancer-related pain can benefit from remote-based monitoring and education programs to improve pain management outcomes, overcome barriers, and increase adherence. Further research is needed to investigate the different available educational methods and long-term effects.",2022,"RESULTS


Significant differences were found between the groups in the levels of pain right now (p = .030), pain at its least (p = .016), and in the percentage of achieved pain relief (p = .048).","['Outpatient Pain Clinic', '134 patients was assigned to two groups; 68 in the intervention group and 66 in the control']","['educational sessions by telephone', 'remote-based monitoring and education program', 'Remote-Based Monitoring and Education Program']","['levels of pain right now', 'Cancer Pain Management', 'harmful effects', 'pain', 'adherence levels', 'percentage of achieved pain relief', 'subscales of physiological effects', 'levels of interference with their general activity']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0441655', 'cui_str': 'Activity'}]",134.0,0.0343671,"RESULTS


Significant differences were found between the groups in the levels of pain right now (p = .030), pain at its least (p = .016), and in the percentage of achieved pain relief (p = .048).","[{'ForeName': 'Abdullah T', 'Initials': 'AT', 'LastName': 'Obaid', 'Affiliation': 'Pain Management Nursing Team, King Hussein Cancer Center, Amman, Jordan. Electronic address: a.obaid555@gmail.com.'}, {'ForeName': 'Mustafa Z', 'Initials': 'MZ', 'LastName': 'Bader', 'Affiliation': 'Pain Management Nursing Team, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Basel H', 'Initials': 'BH', 'LastName': 'Shroof', 'Affiliation': 'Pain Management Nursing Team, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Ahmad Al', 'Initials': 'AA', 'LastName': 'Hroub', 'Affiliation': 'Nursing Department, King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Hussein Y', 'Initials': 'HY', 'LastName': 'Abukhudair', 'Affiliation': 'Department of Anesthesia and Pain Management Consultant, King Hussein Cancer Center, Amman, Jordan.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2022.04.004']
1970,35701227,Combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer disease: a randomised controlled study (abridged secondary publication).,,2022,,['elders with mild clinical Alzheimer disease'],['Combined physical exercise-working memory training'],[],"[{'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.123718,,"[{'ForeName': 'L C W', 'Initials': 'LCW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong.'}, {'ForeName': 'W C', 'Initials': 'WC', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong.'}, {'ForeName': 'T C Y', 'Initials': 'TCY', 'LastName': 'Kwok', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong.'}, {'ForeName': 'J S W', 'Initials': 'JSW', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Alice Ho Miu Ling Nethersole Hospital.'}, {'ForeName': 'B M L', 'Initials': 'BML', 'LastName': 'Yu', 'Affiliation': 'Social Welfare Department, Hong Kong SAR Government.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong.'}, {'ForeName': 'A T C', 'Initials': 'ATC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Ma', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Cheng', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
1971,35701225,Cognitive behavioural therapy for adherence and sub-clinical depression in type 2 diabetes: a randomised controlled trial (abridged secondary publication).,,2022,,['type 2 diabetes'],['Cognitive behavioural therapy'],[],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.254732,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Au', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nan', 'Affiliation': 'Department of Endocrinology, Longhua District Maternal and Child Healthcare Hospital, Shenzhen.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sum', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ng', 'Affiliation': 'Richmond Fellowship of Hong Kong.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kwong', 'Affiliation': 'Department of Family Medicine and Primary Healthcare, Hong Kong West Cluster, Hospital Authority.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'JC School of Public Health and Primary Care, The Chinese University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
1972,35701224,Tai Chi versus brisk walking in reducing cardiovascular risk factors: a randomised controlled trial (abridged secondary publication).,,2022,,[],['Tai Chi versus brisk walking'],['cardiovascular risk factors'],[],"[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.108212,,"[{'ForeName': 'A W K', 'Initials': 'AWK', 'LastName': 'Chan', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong.'}, {'ForeName': 'D T F', 'Initials': 'DTF', 'LastName': 'Lee', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong.'}, {'ForeName': 'J W H', 'Initials': 'JWH', 'LastName': 'Sit', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong.'}, {'ForeName': 'D Y P', 'Initials': 'DYP', 'LastName': 'Leung', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong.'}, {'ForeName': 'L Y L', 'Initials': 'LYL', 'LastName': 'Leung', 'Affiliation': 'Technological and Higher Education Institute of Hong Kong.'}, {'ForeName': 'L C W', 'Initials': 'LCW', 'LastName': 'Fung', 'Affiliation': 'Kwong Wah Hospital.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
1973,35701185,Early Reduction of MRI Activity During 6 Months of Treatment With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: MAGNIFY-MS.,"BACKGROUND AND OBJECTIVES


The onset of action for high-efficacy immunotherapies in multiple sclerosis (MS) is an important parameter. This study (MAGNIFY-MS) evaluates the onset of action of cladribine tablets by observing changes in combined unique active (CUA) MRI lesion counts during the first 6 months of treatment in patients with highly active relapsing MS.
METHODS


MRI was performed at screening, baseline, and at months 1, 2, 3, and 6 after initiating treatment with cladribine tablets 3.5 mg/kg. CUA lesion counts, defined as the sum of T1 gadolinium-enhancing (Gd+) lesions and new or enlarging active T2 lesions (without T1 Gd+), were compared between postbaseline and the baseline period and standardized to the period length and the number of MRIs performed.
RESULTS


Included in this analysis were 270 patients who received ≥1 dose of cladribine tablets. After treatment initiation, significant reductions in mean CUA lesion counts were observed from month 1 onward compared with the baseline period (-1.193 between month 1 and month 6, -1.500 between month 2 and month 6, and -1.692 between month 3 and month 6; all  p  < 0.0001). Mean T1 Gd+ lesion counts were decreased from month 2 onward compared with baseline (-0.857 at month 2, -1.355 at month 3, and -1.449 at month 6; all  p  < 0.0001), whereas the proportion of patients without any CUA lesions increased from 52.0% between month 1 and month 6 to 80.5% between month 3 and month 6.
DISCUSSION


Findings suggest an early onset of action for cladribine tablets, with an increasing reduction in active MRI lesions over time.
TRIAL REGISTRATION INFORMATION


NCT03364036; Date registered: December 06, 2017.
CLASSIFICATION OF EVIDENCE


Using frequent MRI assessments of the brain over the first 6 months of the MAGNIFY-MS study (NCT03364036), we aimed to determine the onset of action of cladribine tablets 3.5 mg/kg in adult patients with highly active relapsing MS. This study provides Class IV evidence that, in such patients, treatment with cladribine tablets is associated with an early onset of action with reductions in active MRI lesion counts from month 2 (day 60) onward, with an increasing reduction in such lesions over time.",2022,"Mean T1 Gd+ lesion counts were decreased from month 2 onward compared with baseline (-0.857 at month 2, -1.355 at month 3, and -1.449 at month 6; all  p  < 0.0001), whereas the proportion of patients without any CUA lesions increased from 52.0% between month 1 and month 6 to 80.5% between month 3 and month 6.
","['270 patients who received ≥1 dose of', 'patients with highly active relapsing MS', 'adult patients with highly active relapsing MS']","['cladribine tablets 3.5 mg/kg', 'Cladribine Tablets', 'cladribine tablets']","['Mean T1 Gd+ lesion counts', 'proportion of patients without any CUA lesions', 'MRI Activity', 'combined unique active (CUA) MRI lesion counts', 'CUA lesion counts, defined as the sum of T1 gadolinium-enhancing (Gd+) lesions and new or enlarging active T2 lesions', 'active MRI lesions', 'mean CUA lesion counts']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}]",270.0,0.0705974,"Mean T1 Gd+ lesion counts were decreased from month 2 onward compared with baseline (-0.857 at month 2, -1.355 at month 3, and -1.449 at month 6; all  p  < 0.0001), whereas the proportion of patients without any CUA lesions increased from 52.0% between month 1 and month 6 to 80.5% between month 3 and month 6.
","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'de Stefano', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany). destefano@unisi.it.""}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Achiron', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Derfuss', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hodgkinson', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Leocani', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schmierer', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Sellebjerg', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Keller', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': ""From the Department of Medicine (N.S.), Surgery and Neuroscience, University of Siena, Siena, Italy; Department of Radiology (F.B.), VU University Medical Center, Amsterdam, The Netherlands; UCL Institute of Neurology (F.B.), London, UK; Department of Neurology-Neuroimmunology (X.M.), Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Universitat Autonoma de Barcelona, Spain; Multiple Sclerosis Center (A.A.), Sheba Academic Medical Center, Ramat Gan, Israel; Department of Neurology (T.D.), University Hospital Basel, Switzerland; Department of Neurology (A.C.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Ingham Institute for Applied Medical Research (S.H.), University of New South Wales Medicine, Sydney, Australia; Department of Neurosciences (A.P.), Université de Montréal, QC, Canada; Experimental Neurophysiology Unit (L.L.), Vita-Salute San Raffaele University, Milan, Italy; The Blizard Institute (K.S.), Centre for Neuroscience, Surgery & Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, UK and; Clinical Board Medicine (Neuroscience) (K.S.), The Royal London Hospital, Barts Health NHS Trust, UK; Danish MS Center (F.S.), Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine (F.S.), University of Copenhagen, Denmark; Univ. Lille (P.V.), Inserm U1172 LilNCog, CHU Lille, FHU Precise, France; Department of Neurology (H.W.), Institute of Translational Neurology, University of Münster, Germany; the healthcare business of Merck KGaA (B.K.), Darmstadt, Germany; and Ares Trading S.A. (S.R.), Eysins, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000001187']
1974,35701155,Treat-to-target dose reduction and withdrawal strategy of TNF inhibitors in psoriatic arthritis and axial spondyloarthritis: a randomised controlled non-inferiority trial.,"OBJECTIVES


Tumour necrosis factor inhibitors (TNFi) are effective in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), but are associated with a small (0.6%) increase in serious infection risk, patient burden due to need for self-injection and high costs. Treat-to-target (T2T) tapering might ameliorate these drawbacks, but high-quality evidence on T2T tapering strategies is lacking in PsA and axSpA.
METHODS


We performed a pragmatic open-label, monocentre, randomised controlled non-inferiority (NI) trial on T2T tapering of TNFi. Patients with PsA and axSpA using a TNFi with ≥6 months stable low disease activity (LDA) were included. Patients were randomised 2:1 to disease activity-guided T2T with or without tapering until withdrawal and followed-up to 12 months. Primary endpoint was the difference in proportion of patients having LDA at 12 months between groups, compared with a prespecified NI margin of 20%, estimated using a Bayesian prior.
RESULTS


122 patients (64 PsA and 58 axSpA) were randomised to a T2T strategy with (N=81) or without tapering (N=41). The proportion of patients in LDA at 12 months was 69% for the tapering and 73% for the no-tapering group: adjusted difference 5% (Bayesian 95% credible interval: -10% to 19%) which confirms NI considering the NI margin of 20%. The mean percentage of daily defined dose was 53% for the tapering and 91% for the no-tapering group at month 12.
CONCLUSIONS


A T2T TNFi strategy with tapering attempt is non-inferior to a T2T strategy without tapering with regard to the proportion of patients still in LDA at 12 months, and results in a substantial reduction of TNFi use.
TRIAL REGISTRATION NUMBER


NL 6771.",2022,"The mean percentage of daily defined dose was 53% for the tapering and 91% for the no-tapering group at month 12.
","['Patients with PsA and axSpA using a TNFi with ≥6 months stable low disease activity (LDA) were included', 'psoriatic arthritis and axial spondyloarthritis', '122 patients (64 PsA and 58 axSpA']","['TNF inhibitors', 'Tumour necrosis factor inhibitors (TNFi', 'disease activity-guided T2T with or without tapering until withdrawal and followed-up to 12 months']","['mean percentage of daily defined dose', 'proportion of patients in LDA', 'proportion of patients having LDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]",,0.149374,"The mean percentage of daily defined dose was 53% for the tapering and 91% for the no-tapering group at month 12.
","[{'ForeName': 'Celia Aj', 'Initials': 'CA', 'LastName': 'Michielsens', 'Affiliation': 'Rheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, The Netherlands celiamichielsens@gmail.com.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'den Broeder', 'Affiliation': 'Rheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Frank Hj', 'Initials': 'FH', 'LastName': 'van den Hoogen', 'Affiliation': 'Rheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Elien Am', 'Initials': 'EA', 'LastName': 'Mahler', 'Affiliation': 'Rheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Radboud Institute for Health Sciences, Department for Health Evidence, group Biostatistics, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Rheumatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Verhoef', 'Affiliation': 'Rheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Alfons A', 'Initials': 'AA', 'LastName': 'den Broeder', 'Affiliation': 'Rheumatology, Sint Maartenskliniek, Nijmegen, Gelderland, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2022-222260']
1975,35701136,[Effects of different crosslinking treatments on the properties of decellularized small intestinal submucosa porous scaffolds].,"OBJECTIVE


To compare the effects of three different crosslinkers on the biocompatibility, physical and chemical properties of decellularized small intestinal submucosa (SIS) porous scaffolds.
METHODS


The SIS porous scaffolds were prepared by freeze-drying method and randomly divided into three groups, then crosslinked by glutaraldehyde (GA), 1-ethyl-3-(3-dimethylaminopropyl) carbodi-imide (EDC) and procyanidine (PA) respectively. To evaluate the physicochemical property of each sample in different groups, the following experiments were conducted. Macroscopic morphologies were observed and recorded. Microscopic morphologies of the scaffolds were observed using field emission scanning electron microscope (FESEM) and representative images were selected. Computer software (ImageJ) was used to calculate the pore size and porosity. The degree of crosslinking was determined by ninhydrin experiment. Collagenase degradation experiment was performed to assess the resistance of SIS scaffolds to enzyme degradation. To evaluate the mechanical properties, universal mechanical testing machine was used to determine the stress-strain curve and compression strength was calculated. Human bone marrow mesenchymal cells (hBMSCs) were cultured on the scaffolds after which cytotoxicity and cell proliferation were assessed.
RESULTS


All the scaffolds remained intact after different crosslinking treatments. The FESEM images showed uniformed interconnected micro structures of scaffolds in different groups. The pore size of EDC group[(161.90±13.44) μm] was significantly higher than GA group [(149.50±14.65) μm] and PA group[(140.10±12.06) μm] ( P  < 0.05). The porosity of PA group (79.62%±1.14%) was significantly lower than EDC group (85.11%±1.71%) and GA group (84.83%±1.89%) ( P  < 0.05). PA group showed the highest degree of crosslinking whereas the lowest swelling ratio. There was a significant difference in the swelling ratio of the three groups ( P  < 0.05). Regarding to the collagenase degradation experiment, the scaffolds in PA group showed a significantly lower weight loss rate than the other groups after 7 days degradation. The weight loss rates of GA group were significantly higher than those of the other groups on day 15, whereas the PA group had the lowest rate after 10 days and 15 days degradation. PA group showed better mechanical properties than the other two groups. More living cells could be seen in PA and EDC groups after live/dead cell staining. Additionally, the proliferation rate of hBMCSs was faster in PA and EDC groups than in GA group.
CONCLUSION


The scaffolds gained satisfying degree of crosslinking after three different crosslinking treatments. The samples after PA and EDC treatment had better physicochemical properties and biocompatibility compared with GA treatment. Crosslinking can be used as a promising and applicable method in the modification of SIS scaffolds.",2022,The pore size of EDC group[(161.90±13.44) μm] was significantly higher than GA group [(149.50±14.65) μm] and PA group[(140.10±12.06) μm] ( P  < 0.05).,[],"['EDC', 'Computer software (ImageJ', 'crosslinked by glutaraldehyde (GA), 1-ethyl-3-(3-dimethylaminopropyl) carbodi-imide (EDC) and procyanidine (PA']","['weight loss rates', 'weight loss rate', 'physicochemical properties and biocompatibility', 'Macroscopic morphologies', 'stress-strain curve and compression strength', 'mechanical properties', 'Human bone marrow mesenchymal cells (hBMSCs', 'proliferation rate of hBMCSs', 'swelling ratio']",[],"[{'cui': 'C0020926', 'cui_str': 'Imide'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0017814', 'cui_str': 'Glutaral'}, {'cui': 'C0072061', 'cui_str': 'procyanidin'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0277764', 'cui_str': 'Human bone for identification'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0190121,The pore size of EDC group[(161.90±13.44) μm] was significantly higher than GA group [(149.50±14.65) μm] and PA group[(140.10±12.06) μm] ( P  < 0.05).,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of General Dentistry Ⅱ, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Li', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
1976,35705390,Randomized Study of Survey Recruitment Strategies for Parents of Autistic Children.,"INTRODUCTION


This study aimed to compare phone, email, or text message recruitment strategies for engaging parents of autistic children in an online survey.
METHOD


In this randomized study, a sample of 1,624 parents of autistic children spectrum disorder (autism) from an integrated health system in Southern California were sent an initial mailed letter and email simultaneously for baseline survey outreach. Then, participants were randomly assigned to one of three follow-up recruitment groups: phone, email, or text message. We compared the efficacy of recruitment strategies in multivariate models.
RESULTS


All three follow-up methods were equally effective for eliciting a survey response. Parents of girls were less likely to respond to survey outreach attempts than parents of boys.
DISCUSSION


Multiple modalities of survey recruitment, including digital and mobile approaches, effectively recruit parents of children in research.",2022,"Then, participants were randomly assigned to one of three follow-up recruitment groups: phone, email, or text message.","['engaging parents of autistic children in an online survey', 'Parents of Autistic Children', '1,624 parents of autistic children spectrum disorder (autism) from an integrated health system in Southern California were sent an initial mailed letter and email simultaneously for baseline survey outreach']",[],[],"[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]",[],[],1624.0,0.0377141,"Then, participants were randomly assigned to one of three follow-up recruitment groups: phone, email, or text message.","[{'ForeName': 'Bhumi B', 'Initials': 'BB', 'LastName': 'Bhakta', 'Affiliation': 'Bhumi B. Bhakta, Research Assistant, Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Coleman', 'Affiliation': 'Karen J. Coleman, Research Scientist III, Department of Research and Evaluation, and Southern California Permanente Medical Group, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Choi', 'Affiliation': 'Kristen R. Choi, Assistant Professor, Department of Health Policy and Management, Fielding School of Public Health, and School of Nursing, University of California Los Angeles, Los Angeles, CA; Adjunct Investigator, Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA. Electronic address: krchoi@ucla.edu.'}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2022.05.008']
1977,35705386,Implementation of a nutritional supplementation program in a population of Cambodian children and its impact on statural growth.,"BACKGROUND


Stunting is a major health problem in low-income countries. We aimed to describe the implementation of a lipid-based nutrient supplement (LNS) program in a rural neighborhood in Cambodia and to assess its impact on statural growth.
METHOD


This was a before-after comparative study. The program was promoted by the Pédiatres du Monde (PDM) organization between 2011 and 2019 in six villages in a rural area in Cambodia. The supplementation program consisted of daily administration of LNS during the third semester of pregnancy for the mothers and then between 6 and 24 months of age for the toddlers. Anthropometric data of the children were recorded during PDM visits before and after the program implementation, which allowed us to compare child growth in the two groups: control and intervention groups. Primary outcome was height-for-age between 24 and 35 months of age.
RESULTS


Overall, 198 data were collected for children between 24 and 35 months of age in the control group. A total of 347 pregnant women were enrolled in the intervention phase. A total of 188 data were collected for children between 24 and 35 months of age in the intervention group. The mean height-for-age z-score in the population receiving LNS was higher than in the control group (-1.14 vs. -1.60, p < 0.001). There was no significant difference between the two groups regarding the weight-for-height z-score (WHZ; -1.11 vs. -1.26, p = 0.18) and children in the intervention group had a higher middle upper-arm circumference z-score (MUACZ; -0.75 vs.. -1.1, p < 0.001).
CONCLUSION


LNS supplementation significantly and increased the HAZ between 24 and 35 months of age. However, the fight against malnutrition is complex and needs intervention on multiple levels.",2022,"The mean height-for-age z-score in the population receiving LNS was higher than in the control group (-1.14 vs. -1.60,","['347 pregnant women were enrolled in the intervention phase', 'A total of 188 data were collected for children between 24 and 35 months of age in the intervention group']","['lipid-based nutrient supplement (LNS) program', 'LNS', 'nutritional supplementation program', 'LNS supplementation']","['higher middle upper-arm circumference z-score', 'height-for-age', 'HAZ', 'mean height-for-age z-score', 'weight-for-height z-score']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}]",347.0,0.0359222,"The mean height-for-age z-score in the population receiving LNS was higher than in the control group (-1.14 vs. -1.60,","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Pédiatres du Monde (PDM) Organization, Sèvres, France. Electronic address: astrid.molto@gmail.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mortamet', 'Affiliation': 'Pediatric Intensive Care Unit, Grenoble-Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kempf', 'Affiliation': 'Pédiatres du Monde (PDM) Organization, Sèvres, France.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Thiron', 'Affiliation': 'Pédiatres du Monde (PDM) Organization, Sèvres, France; Association Française de Pédiatrie Ambulatoire, Bagnols-sur-Cèze, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vié le Sage', 'Affiliation': 'Pédiatres du Monde (PDM) Organization, Sèvres, France; Association Française de Pédiatrie Ambulatoire, Bagnols-sur-Cèze, France.'}]",Archives de pediatrie : organe officiel de la Societe francaise de pediatrie,['10.1016/j.arcped.2022.05.008']
1978,35701752,Effectiveness of educational intervention and cognitive rehearsal on perceived incivility among emergency nurses: a randomized controlled trial.,"BACKGROUND


Witnessing or experiencing of incivility affected the nurses' perception of the ethical climate and quality of their work life. The aim of this study was to investigate the effectiveness of educational intervention and cognitive rehearsal on perceived incivility among emergency nurses.
METHOD


This study was conducted as a randomized controlled parallel group clinical trial. Eighty emergency nurses participated in this study and were randomly assigned to intervention and control groups during December 2019-March 2020. Cognitive rehearsal program (include of definitions of incivility, ten common incivilities and appropriate practice methods for responding to each and role-plays) was delivered in five two-hour sessions over three weeks on different working days and shifts. The control group received only written information about what incivility is and how to deal with it before the implementation of intervention and one month after the completion of the training sessions, the demographic information form and the incivility scale were completed by the nurses.
RESULTS


The results showed that there was a significant effect on overall incivility, general incivility, and supervisor incivility between the intervention and control groups. However, these significant reductions were seen in control group who received only written education. There were no significant differences in nurse's incivility towards other nurses, physician incivility, and patient/visitor incivility between the two groups.
CONCLUSION


The cognitive rehearsal program did not decrease perceived incivility among emergency department nurses in the short term.
TRIAL REGISTRATION


Our research was registered on clinicaltrials.gov.
REGISTRATION NUMBER


IRCT20200714048104N1 , first registration 16/07/2020.",2022,"There were no significant differences in nurse's incivility towards other nurses, physician incivility, and patient/visitor incivility between the two groups.
","['emergency nurses', 'Eighty emergency nurses']","['cognitive rehearsal program', 'Cognitive rehearsal program', 'educational intervention and cognitive rehearsal']","[""nurse's incivility towards other nurses, physician incivility, and patient/visitor incivility"", 'overall incivility, general incivility, and supervisor incivility']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4505292', 'cui_str': 'Rudeness'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}]",80.0,0.053571,"There were no significant differences in nurse's incivility towards other nurses, physician incivility, and patient/visitor incivility between the two groups.
","[{'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Kousha', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shahrami', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Forouzanfar', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Sanaie', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Foroozan', 'Initials': 'F', 'LastName': 'Atashzadeh-Shoorideh', 'Affiliation': 'Department of Psychiatric Nursing and Management, School of Nursing and Midwifery, Shahid Labbafinezhad Hospital, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Opposite to Rajaee Heart Hospital, Tehran, 1996835119, Iran. f_atashzadeh@sbmu.ac.ir.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Skerrett', 'Affiliation': 'Mental Health Nursing, Birmingham City University, Birmingham, UK.'}]",BMC nursing,['10.1186/s12912-022-00930-1']
1979,35701749,Knowledge and practice of nursing students regarding bioterrorism and emergency preparedness: comparison of the effects of simulations and workshop.,"BACKGROUND AND PURPOSE


Bioterrorism is a global threat. Nurses are one of the first groups that should be ready for it. College years are the best time to educate these issues. This study aimed to compare the effectiveness of simulation and workshop on knowledge and practice of nursing students regarding bioterrorism.
MATERIALS AND METHODS


This was an experimental study. The study sample consisted of 40 last-year nursing students who were randomly assigned to two groups by using random numbers table. Data was collected using a demographic questionnaire, bioterrorism knowledge scale, and an OSCE checklist. Before the intervention, the students completed the study questionnaires and a six-station OSCE test. The workshop group (20 students) learned how to deal with bioterrorism through lectures. The simulation group (20 students) participated in a simulation learning program. After one month, the students completed the study tools again. Finally, collected data were analyzed using descriptive and inferential statistics in SPSS V.16.
RESULTS


The difference between the knowledge and performance scores of both groups (workshop and simulation), before and after the intervention, was statistically significant (P < 0.001). Students in both groups had higher knowledge and performance scores after the intervention. The simulation group scores were higher than the workshop group scores in the knowledge and the most of performance domains.
CONCLUSION


The simulation group had better results in terms of enhancing knowledge, preparedness, disaster triage, reporting, incident management, communication, mental disorders, and isolation domains compared to the workshop group.",2022,"The simulation group had better results in terms of enhancing knowledge, preparedness, disaster triage, reporting, incident management, communication, mental disorders, and isolation domains compared to the workshop group.",['40 last-year nursing students'],"['simulation learning program', 'simulation and workshop']","['demographic questionnaire, bioterrorism knowledge scale, and an OSCE checklist', 'enhancing knowledge, preparedness, disaster triage, reporting, incident management, communication, mental disorders, and isolation domains', 'knowledge and performance scores']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0086858', 'cui_str': 'Programmed Learning'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0872021', 'cui_str': 'Biological Terrorism'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0118451,"The simulation group had better results in terms of enhancing knowledge, preparedness, disaster triage, reporting, incident management, communication, mental disorders, and isolation domains compared to the workshop group.","[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Ghahremani', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rooddehghan', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Rooddehghan@tums.ac.ir.'}, {'ForeName': 'Shokouh', 'Initials': 'S', 'LastName': 'Varaei', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}]",BMC nursing,['10.1186/s12912-022-00917-y']
1980,35701734,Correction to: Effects of aerobic exercise on quality of life of people with HIV-associated neurocognitive disorder on antiretroviral therapy: a randomised controlled trial.,,2022,,['people with\xa0HIV-associated neurocognitive disorder on\xa0antiretroviral therapy'],['aerobic exercise'],['quality of\xa0life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.242397,,"[{'ForeName': 'Martins', 'Initials': 'M', 'LastName': 'Nweke', 'Affiliation': 'Department of Physiotherapy, School of Healthcare Sciences, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa. martins.nweke@gmail.com.'}, {'ForeName': 'Nombeko', 'Initials': 'N', 'LastName': 'Mshunqane', 'Affiliation': 'Department of Physiotherapy, School of Healthcare Sciences, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Govender', 'Affiliation': 'Department of Basic Medical Sciences, Durban University of Technology, Durban, South Africa.'}, {'ForeName': 'Aderonke O', 'Initials': 'AO', 'LastName': 'Akinpelu', 'Affiliation': 'Department of Physiotherapy, Faculty of Clinical Sciences, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Adesola', 'Initials': 'A', 'LastName': 'Ogunniyi', 'Affiliation': 'Department of Medicine, Faculty of Clinical Sciences, University of Ibadan, Ibadan, Nigeria.'}]",BMC infectious diseases,['10.1186/s12879-022-07524-x']
1981,35701732,Effectiveness of a brief hope intervention for chronic kidney disease patients on the decisional conflict and quality of life: a pilot randomized controlled trial.,"BACKGROUND


Stage 5 chronic kidney disease (CKD) patients often experience decisional conflict when faced with the selection between the initiation of dialysis and conservative care. The study examined the effects of a brief hope intervention (BHI) on the levels of hope, decisional conflict and the quality of life for stage 5 CKD patients.
METHODS


This is a single-blinded, randomized controlled trial (ClinicalTrials.gov identifier: NCT03378700). Eligible patients were recruited from the outpatient department renal clinic of a regional hospital. They were randomly assigned to either the intervention or the control group (intervention: n = 35; control: n = 37). All participants underwent a customized pre-dialysis education class, while the intervention group received also BHI. Data were collected prior to the intervention, immediately afterwards, and one month following the intervention. The Generalized Estimating Equation was used to measure the effects in the level of hope, decisional conflict scores (DCS) and Kidney Disease Quality of life (KDQOL-36) scores. Estimated marginal means and standard errors with 95% confidence intervals of these scores were also reported to examine the within group and between group changes.
RESULTS


An increase of the hope score was found from time 1 (29.7, 1.64) to time 3 (34.4, 1.27) in the intervention group. The intervention had a significant effect on the KDQOL-36 sub-scores Mental Component Summary (MCS) (Wald χ 2  = 6.763, P = 0.009) and effects of kidney disease (Wald χ 2  = 3.617, P = 0.004). There was a reduction in decisional conflict in both arms on the DCS total score (Wald χ 2  = 7.885, P = 0.005), but the reduction was significantly greater in the control group (effect size 0.64).
CONCLUSIONS


The BHI appeared to increase the level of hope within the intervention arm. Nonetheless, differences across the intervention and control arms were not significant. The KDQOL-36 sub-scores on MCS and Effects of kidney disease were found to have increased and be higher in the intervention group. The DCS total score also showed that hope was associated with reducing decisional conflict.
TRIAL REGISTRATION


ClinicalTrials.gov Protocol Registration, NCT03378700 . Registered July 12 2017.",2022,"An increase of the hope score was found from time 1 (29.7, 1.64) to time 3 (34.4, 1.27) in the intervention group.","['Eligible patients were recruited from the outpatient department renal clinic of a regional hospital', 'chronic kidney disease patients', 'stage 5 CKD patients', 'Stage 5 chronic kidney disease (CKD) patients']","['brief hope intervention', 'brief hope intervention (BHI', 'customized pre-dialysis education class, while the intervention group received also BHI', 'control group (intervention: n\u2009=\u200935; control: n\u2009=\u200937']","['levels of hope, decisional conflict and the quality of life', 'kidney disease', 'KDQOL-36 sub-scores Mental Component Summary (MCS', 'KDQOL-36 sub-scores on MCS and Effects of kidney disease', 'decisional conflict', 'decisional conflict and quality of life', 'hope score', 'DCS total score', 'level of hope, decisional conflict scores (DCS) and Kidney Disease Quality of life (KDQOL-36) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2316810', 'cui_str': 'Chronic kidney disease stage 5'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0424133', 'cui_str': 'Level of hope'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0749521,"An increase of the hope score was found from time 1 (29.7, 1.64) to time 3 (34.4, 1.27) in the intervention group.","[{'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Chan', 'Affiliation': ""School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong SAR, People's Republic of China. kitty.yy.chan@polyu.edu.hk.""}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': ""School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong SAR, People's Republic of China.""}, {'ForeName': 'Suet Lai', 'Initials': 'SL', 'LastName': 'Tam', 'Affiliation': ""Department of Medicine and Geriatrics, Kwong Wah Hospital, 25 Waterloo Road, Kowloon, Hong Kong SAR, People's Republic of China.""}, {'ForeName': 'Ching Ping', 'Initials': 'CP', 'LastName': 'Kwok', 'Affiliation': ""Department of Medicine and Geriatrics, Kwong Wah Hospital, 25 Waterloo Road, Kowloon, Hong Kong SAR, People's Republic of China.""}, {'ForeName': 'Yuen Ping', 'Initials': 'YP', 'LastName': 'Fung', 'Affiliation': ""Department of Medicine and Geriatrics, Kwong Wah Hospital, 25 Waterloo Road, Kowloon, Hong Kong SAR, People's Republic of China.""}, {'ForeName': 'Ping Nam', 'Initials': 'PN', 'LastName': 'Wong', 'Affiliation': ""Department of Medicine and Geriatrics, Kwong Wah Hospital, 25 Waterloo Road, Kowloon, Hong Kong SAR, People's Republic of China.""}]",BMC nephrology,['10.1186/s12882-022-02830-7']
1982,35702079,Clinical efficacy of nutritional diet therapy on gestational diabetes mellitus.,"OBJECTIVE


To analyze the clinical effect of nutritional diet therapy on gestational diabetes mellitus (GDM).
METHODS


One hundred pregnant women with GDM who were admitted to Ji'nan Central Hospital were enrolled in this study. The patients were divided into an observation group (received individualized nutrition nursing, n=50) and a control group (received routine nursing, n=50).
RESULTS


The total incidence of postpartum complications in the control group was 28.00%, which was significantly higher than 8.00% in the observation group (χ 2 =4.500, P=0.034). After nursing, the amniotic fluid index in the observation group increased significantly as compared with the control group (P<0.001). The nursing satisfaction rate of the observation group was higher than that of the control group. The difference was statistically significant (t=14.324, P<0.001). The health condition of newborns in the observation group was better than that in the control group (χ 2 =4.762, P=0.029). After intervention, the level of blood glucose of women in the observation group was better than that of the control group (P<0.05).
CONCLUSION


Nutritional diet therapy for pregnant women with GDM can help to reduce complications, control blood sugar, and improve the neonatal outcome. It is also conducive to the postpartum rehabilitation of pregnant women. It is worthy of clinical application and promotion.",2022,"The health condition of newborns in the observation group was better than that in the control group (χ 2 =4.762, P=0.029).","['gestational diabetes mellitus', 'gestational diabetes mellitus (GDM', 'pregnant women', 'pregnant women with GDM', ""One hundred pregnant women with GDM who were admitted to Ji'nan Central Hospital were enrolled in this study""]","['individualized nutrition nursing', 'nutritional diet therapy', 'control group (received routine nursing, n=50', 'Nutritional diet therapy']","['level of blood glucose', 'total incidence of postpartum complications', 'nursing satisfaction rate', 'amniotic fluid index', 'health condition of newborns']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0552315', 'cui_str': 'Amniotic fluid index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]",100.0,0.0208138,"The health condition of newborns in the observation group was better than that in the control group (χ 2 =4.762, P=0.029).","[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Obstetrics, Ji'nan Central Hospital Ji'nan, Shandong, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""Department of Obstetrics, Ji'nan Central Hospital Ji'nan, Shandong, China.""}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Mi', 'Affiliation': ""Department of Obstetrics, Ji'nan Central Hospital Ji'nan, Shandong, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics, Ji'nan Central Hospital Ji'nan, Shandong, China.""}]",American journal of translational research,[]
1983,35702033,Effect of Altmetric score on manuscript citations: A randomized-controlled trial.,"BACKGROUND


Alternative metrics to traditional, citation-based metrics are increasingly being used. These are complementary to traditional metrics, like downloads and citations, and give information on how often a given journal article is discussed and used in professional (reference managers) and social networks, such as mainstream media and Twitter. Altmetrics is used in most journals and is available in all indexed headache medicine journals. Whether Altmetrics have an input on traditional, citation-based metrics or whether it is a stand-alone metric system is not clear. Actively promoting a paper through media channels will probably increase the Altmetric score but the question arises whether this will also increase citations and downloads of this individual paper.
METHODS


Focusing on this point we performed a randomized study in order to test the hypothesis that a promotion intervention would improve citations and other science metric scores. We selected 48 papers published in  Cephalalgia  from July 2019 to January 2020 and randomized them to either receive an active promotion through social media channels or not. The primary outcome used was the difference between mean article citations  with  versus  without  intervention 12 months after the intervention period.
RESULTS


The results show that the alternative metrics significantly increased for those papers randomly selected to receive an intervention compared to those who did not. This effect was observed in the first 12 months, right after the boosting strategy was performed. The higher promoted paper diffusion in social media lead to a significantly higher number of citations and downloads.
CONCLUSION


Further promotion strategies should be studied in order to tailor the best cost-benefit intervention.",2022,The results show that the alternative metrics significantly increased for those papers randomly selected to receive an intervention compared to those who did not.,['48 papers published in  Cephalalgia  from July 2019 to January 2020'],"['promotion intervention', 'active promotion through social media channels or not']",['Altmetric score'],"[{'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0439799', 'cui_str': 'Channel'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",,0.030652,The results show that the alternative metrics significantly increased for those papers randomly selected to receive an intervention compared to those who did not.,"[{'ForeName': 'Mario Fp', 'Initials': 'MF', 'LastName': 'Peres', 'Affiliation': 'Sao Paulo Headache Center, Albert Einstein Hospital, Institute of Psychiatry - HCFMUSP in São Paulo, Brazil.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Braschinsky', 'Affiliation': 'Neurology Clinic, Tartu University, Tartu, Estonia.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'May', 'Affiliation': 'Department of Systems Neuroscience, University Clinic Hamburg Eppendorf, Hamburg, Germany.'}]",Cephalalgia : an international journal of headache,['10.1177/03331024221107385']
1984,35702007,Capacitive resistive monopolar radiofrequency at 448 kHz plus exercising versus exercising alone for subacromial pain: A sham-controlled randomized clinical trial.,"OBJECTIVE


To investigate the effectiveness of thermal and sub-thermal capacitive-resistive monopolar radiofrequency at 448 kHz plus exercising compared to sham radiofrequency plus exercising on pain, functionality, and quality of life in patients with subacromial pain.
DESIGN


Randomized, controlled, parallel, double-blind, three-arm clinical trial.
SETTING


Hospital and Primary Care.
SUBJECTS


Eighty-one participants with subacromial pain in three intervention groups.
INTERVENTIONS


Three interventions with capacitive-resistive radiofrequency (thermal, sub-thermal, and sham) over 9 sessions (3 per week) plus an exercising protocol identical for all groups over 15 sessions (5 per week).
OUTCOME MEASURES


Visual analogue scale and pressure pain threshold for pain, Shoulder Pain and Disability Index and Quick-Disabilities of the Arm, Shoulder and Hand for functionality, and quality of life via the European Quality of Life-Five Dimensions were assessed at baseline, immediately posttreatment, and 1 month and 3 months post-intervention.
RESULTS


No between-group differences were found in the pain visual analogue scale (F = 1.0;  P  = 0.37), Shoulder Pain and Disability Index (F = 1.0;  P  = 0.36), European Quality of Life-Five Dimensions (F = 0.76;  P  = 0.47), and pressure pain (F = 0.14;  P  = 0.86) outcomes, with a statistical power < 0.30 for all comparisons. Between-group differences were found in the Quick-Disabilities of the Arm, Shoulder and Hand (F = 3.4;  P  < 0.038), with an improvement of -14.1 points (confidence interval at 95% (95% CI) -28.1 to -0.1) in the thermal versus the sham group at 1 month follow-up. The mobility dimension of European Quality of Life-Five Dimensions improved in a greater proportion of participants in the thermal group (22.2% thermal, 7.4% sub-thermal, and 0.0% sham;  P  = 0.02).
CONCLUSION


Adding thermal radiofrequency to exercising can further improve slightly functionality and mobility in people with subacromial pain in the short term, but not pain perception. Future studies with larger sample sizes are warranted to increase statistical power.",2022,"The mobility dimension of European Quality of Life-Five Dimensions improved in a greater proportion of participants in the thermal group (22.2% thermal, 7.4% sub-thermal, and 0.0% sham;  P  = 0.02).
","['subacromial pain', 'Hospital and Primary Care', 'patients with subacromial pain', 'Eighty-one participants with subacromial pain in three intervention groups']","['thermal and sub-thermal capacitive-resistive monopolar radiofrequency', 'capacitive-resistive radiofrequency (thermal, sub-thermal, and sham) over 9 sessions (3 per week) plus an exercising protocol', 'Capacitive resistive monopolar radiofrequency at 448 kHz plus exercising versus exercising alone']","['pain, functionality, and quality of life', 'mobility dimension of European Quality of Life-Five Dimensions', 'pressure pain ', 'Shoulder Pain and Disability Index', 'Visual analogue scale and pressure pain threshold for pain, Shoulder Pain and Disability Index and Quick-Disabilities of the Arm, Shoulder and Hand for functionality, and quality of life via the European Quality of Life-Five Dimensions', 'European Quality of Life-Five Dimensions', 'Quick-Disabilities', 'pain visual analogue scale']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0556965', 'cui_str': 'kHz'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",81.0,0.197416,"The mobility dimension of European Quality of Life-Five Dimensions improved in a greater proportion of participants in the thermal group (22.2% thermal, 7.4% sub-thermal, and 0.0% sham;  P  = 0.02).
","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Avendaño-Coy', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), 16500Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Aceituno-Gómez', 'Affiliation': 'Faculty of Physical Therapy and Nursing, 16733Castilla-La Mancha University, Toledo, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'García-Durán', 'Affiliation': 'Faculty of Physical Therapy and Nursing, 16733Castilla-La Mancha University, Toledo, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Arroyo-Fernández', 'Affiliation': 'Faculty of Physical Therapy and Nursing, 16733Castilla-La Mancha University, Toledo, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Blázquez-Gamallo', 'Affiliation': 'Talavera Integrated Health Area (Castilla La Mancha Health Service - SESCAM), Talavera de la Reina, Spain.'}, {'ForeName': 'Venancio Miguel', 'Initials': 'VM', 'LastName': 'García-Madero', 'Affiliation': 'Talavera Integrated Health Area (Castilla La Mancha Health Service - SESCAM), Talavera de la Reina, Spain.'}, {'ForeName': 'Sara Maruxa', 'Initials': 'SM', 'LastName': 'Escribá-de-la-Fuente', 'Affiliation': 'Talavera Integrated Health Area (Castilla La Mancha Health Service - SESCAM), Talavera de la Reina, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernández-Pérez', 'Affiliation': 'Talavera Integrated Health Area (Castilla La Mancha Health Service - SESCAM), Talavera de la Reina, Spain.'}]",Clinical rehabilitation,['10.1177/02692155221107736']
1985,35702003,Using Community Health Workers to Improve Health Outcomes in a Sample of Hispanic Women and Their Infants: Findings from a Randomized Controlled Trial.,"Introduction:  The Maternal Infant Health Outreach Worker (MIHOW) program, an early childhood home visiting program, uses community health workers (CHWs) to improve health outcomes in underserved communities.  Methods:  This randomized clinical trial evaluated the impact of MIHOW's use of CHWs on selected maternal/infant outcomes up to 15 months postpartum. We hypothesized outcomes would be better among Hispanic women receiving MIHOW compared to a similar group of women eligible for MIHOW who received only a minimal education intervention (MEI). The study also expanded earlier research testing MIHOW's efficacy among Hispanic families using criteria set forth by federal guidelines. Women living in middle Tennessee enrolled during pregnancy (≤26 weeks gestation) and continued through 15 months postpartum.  Results:  Enrolled women ( N  = 132) were randomly assigned, with 110 women completing the study ( MEI  = 53;  MIHOW  = 57). Positive and statistically significant ( p  < .01) effects of MIHOW were observed on breastfeeding duration, safe sleep practices, stress levels, depressive symptoms, emotional support, referral follow through, parental confidence, and infant stimulation in the home.  Conclusions:  Findings provided strong evidence of the effectiveness of MIHOW for improving health outcomes in this sample. Using trained CHWs makes programs such as MIHOW a viable option for providing services to immigrant and underserved families.",2022,"Positive and statistically significant ( p  < .01) effects of MIHOW were observed on breastfeeding duration, safe sleep practices, stress levels, depressive symptoms, emotional support, referral follow through, parental confidence, and infant stimulation in the home.  ","['Women living in middle Tennessee enrolled during pregnancy (≤26 weeks gestation) and continued through 15 months postpartum', 'Enrolled women ( N \u2009=\u2009132', 'Hispanic Women and Their Infants', 'Hispanic families using criteria set forth by federal guidelines', 'Hispanic women receiving MIHOW compared to a similar group of women eligible for MIHOW who received only a minimal education intervention (MEI', 'underserved communities']",['CHWs'],"['Health Outcomes', 'breastfeeding duration, safe sleep practices, stress levels, depressive symptoms, emotional support, referral follow through, parental confidence, and infant stimulation in the home']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0039514', 'cui_str': 'Tennessee'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",132.0,0.116098,"Positive and statistically significant ( p  < .01) effects of MIHOW were observed on breastfeeding duration, safe sleep practices, stress levels, depressive symptoms, emotional support, referral follow through, parental confidence, and infant stimulation in the home.  ","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lutenbacher', 'Affiliation': '16194Vanderbilt University School of Nursing, Nashville, TN, USA.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Elkins', 'Affiliation': '16194Vanderbilt University School of Nursing, Nashville, TN, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': '16194Vanderbilt University School of Nursing, Nashville, TN, USA.'}]",Hispanic health care international : the official journal of the National Association of Hispanic Nurses,['10.1177/15404153221107680']
1986,35701994,Total Hip Arthroplasty with Robotic Arm Assistance for Precise Cup Positioning: A Case-Control Study.,"OBJECTIVE


To determine whether more precise cup positioning can be achieved with robot-assisted total hip arthroplasty (THA) as compared to conventional THA.
METHODS


In this study, between July 2019 and May 2021, 93 patients aged 23-75 years with osteonecrosis of the femoral head (ONFH) and adult developmental dysplasia of hip who underwent first hip surgery were included in the study. They were randomly assigned to either the robotic-assisted THA group (n = 45) or the conventional THA group (n = 48). After the operation, all patients were given routine rapid rehabilitation guidance. The duration of operation was recorded to estimate the learning curve through cumulative summation analysis. We compared the demographics, duration of operation, cup positioning, leg length discrepancy, hip offset, and Harris Hip Score between robot-assisted THA and manual THA. Precision in the positioning of the acetabular prosthesis using the MAKO system was also compared between the two groups.
RESULTS


The mean duration of operation for the robot-assisted THA group was 91.37 ± 17.34 min (range: 63 to 135 min), which was significantly higher than that for the conventional THA group. When the number of procedures was increased to 13, the duration of operation in the robot-assisted group decreased significantly and gradually became stable. In terms of duration of operation, robot-assisted THA was associated with a learning curve of 13 cases. The mean amount of bleeding in the robot-assisted THA group was not significantly different from that in conventional THA group (328 ± 210 ml vs 315 ± 205 ml) (p = 0.741). There was no significant difference in the proportion of prostheses located within Lewinnek's safe zone between robot-assisted THA group and conventional THA group (69.81% vs 64.41%). The leg length discrepancy (LLD) was significantly smaller in the robot-assisted THA group than in the conventional THA group (p < 0.001), but both were within acceptable limits (10 mm). The inclination and anteversion angles of the acetabular prosthesis planned before operations were correlated with the actual measurement (r = 0.857 p < 0.001, r = 0.830, p < 0.001). After surgery, none of the patients experienced hip dislocation, aseptic loosening, or periprosthetic infection during the 3 months of follow-up.
CONCLUSION


The proportion of acetabular prostheses in the Lewinnek's safety zone was higher and the extent of LLD was significantly lower in the robot-assisted THA group, as compared to the same metrics in the conventional THA group. The MAKO robot improved the accuracy of implant placement in THA.",2022,"The leg length discrepancy (LLD) was significantly smaller in the robot-assisted THA group than in the conventional THA group (p < 0.001), but both were within acceptable limits (10 mm).","['between July 2019 and May 2021, 93 patients aged 23-75\u2009years with osteonecrosis of the femoral head (ONFH) and adult developmental dysplasia of hip who underwent first hip surgery were included in the study']","['conventional THA', 'robotic-assisted THA', 'Total Hip Arthroplasty with Robotic Arm Assistance for Precise Cup', 'robot-assisted total hip arthroplasty (THA']","['mean amount of bleeding', 'hip dislocation, aseptic loosening, or periprosthetic infection', 'LLD', 'duration of operation', 'demographics, duration of operation, cup positioning, leg length discrepancy, hip offset, and Harris Hip Score between robot-assisted THA and manual THA', 'leg length discrepancy (LLD', 'mean duration of operation', 'accuracy of implant placement', ""proportion of prostheses located within Lewinnek's safe zone"", 'proportion of acetabular prostheses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4551649', 'cui_str': 'Congenital hip dysplasia'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336542', 'cui_str': 'Robotic arm'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0336537', 'cui_str': 'Robot'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019554', 'cui_str': 'Dislocation of hip joint'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023221', 'cui_str': 'Leg length inequality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]",93.0,0.0482816,"The leg length discrepancy (LLD) was significantly smaller in the robot-assisted THA group than in the conventional THA group (p < 0.001), but both were within acceptable limits (10 mm).","[{'ForeName': 'Dong-Hui', 'Initials': 'DH', 'LastName': 'Guo', 'Affiliation': 'Department of Orthopaedic Surgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, China.'}, {'ForeName': 'Shi-Qiang', 'Initials': 'SQ', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedic Surgery, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, China.'}, {'ForeName': 'Yun-Chao', 'Initials': 'YC', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopaedic Surgery, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Qi', 'Affiliation': 'Department of Orthopaedic Surgery, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Cangzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Orthopaedic Surgery, Tianjin Medical University General Hospital, Tianjin, China.'}]",Orthopaedic surgery,['10.1111/os.13334']
1987,35701842,Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial.,"BACKGROUND


Digital cognitive behavioral therapy for insomnia (CBT-i) in people with low back pain (LBP) may be efficacious in improving both sleep and pain; and twin trial designs provide greater precision of treatment effects by accounting for genetic and early environmental factors. We aimed to determine the feasibility of a trial investigating the efficacy of a digital CBT-i program in people with comorbid symptoms of insomnia and LBP, in twins and people from the general community (singletons).
METHODS


Thirty-two twins (16 pairs) and 66 singletons with comorbid symptoms of insomnia and LBP (> 6 weeks duration) were randomized to digital CBT-i (intervention) or educational program (control) for 6 weeks. The digital CBT-I, Sleepio (developed by Big Health Inc.), was an online interactive, automated, personalized course comprising of six sessions, once a week. The education program was six emails with general sleep information, once a week. Participants were blinded to their group allocation and offered the alternative intervention at the completion of the study. Feasibility outcomes included recruitment and follow-up rates, data collection and outcome measure completion, contamination (communication about trial interventions), acceptability (adherence), credibility, and participants' experience of the intervention.
RESULTS


Sixteen out of 722 contacted twin pairs were recruited (recruitment rate = 2.2%). Twins were recruited between September 2015 and August 2018 (35 months) and singletons between October 2017 and Aug 2018 (10 months). Follow-up rates for post-intervention and 3-month follow-up were 81% and 72% for twins and 82% and 78% for singletons respectively. Adherence rates (percentage of sessions completed out of six) for the digital CBT-i were 63% for twins and 55% for singletons. Contamination (speaking about the study to each other) was present in two twin pairs (13%). Written or verbal feedback (n = 21) regarding the digital CBT-i intervention from participants were positive (n = 11), neutral (n = 5), or negative (n = 6).
CONCLUSIONS


Online CBT-i was received favorably with people with comorbid symptoms of insomnia and LBP. While the online data collection was successful, strategies need to be implemented to improve adherence, follow-up, control group credibility (for digital CBT-i), and twin recruitment rates (for twin trials).
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ( ACTRN12615000672550 ). Registered 29 June 2015.",2022,Follow-up rates for post-intervention and 3-month follow-up were 81% and 72% for twins and 82% and 78% for singletons respectively.,"['Twins were recruited between September 2015 and August 2018 (35\u2009months) and singletons between October 2017 and Aug 2018 (10\u2009months', 'Sixteen out of 722 contacted twin pairs', 'people with comorbid symptoms of insomnia and LBP, in twins and people from the general community (singletons', 'people with low back pain (LBP', 'Thirty-two twins (16 pairs) and 66 singletons with comorbid symptoms of insomnia and LBP (>\u20096\u2009weeks duration', 'people with low back pain']","['digital CBT-i program', 'digital cognitive behavioral therapy', 'Digital cognitive behavioral therapy', 'Written or verbal feedback (n\u2009=\u200921) regarding the digital CBT-i intervention', 'digital CBT-i (intervention) or educational program (control']","['Adherence rates', ""recruitment and follow-up rates, data collection and outcome measure completion, contamination (communication about trial interventions), acceptability (adherence), credibility, and participants' experience of the intervention""]","[{'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.112957,Follow-up rates for post-intervention and 3-month follow-up were 81% and 72% for twins and 82% and 78% for singletons respectively.,"[{'ForeName': 'Kevin K N', 'Initials': 'KKN', 'LastName': 'Ho', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Sydney, NSW, 2050, Australia. kevin.ho@sydney.edu.au.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Simic', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Sydney, NSW, 2050, Australia.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'Pinheiro', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Sydney, NSW, 2050, Australia.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, USA.'}, {'ForeName': 'Manuela L', 'Initials': 'ML', 'LastName': 'Ferreira', 'Affiliation': 'Institute of Bone and Joint Research, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'CIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hopper', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Juan R', 'Initials': 'JR', 'LastName': 'Ordoñana', 'Affiliation': 'Murcia Twin Registry, Department of Human Anatomy and Psychobiology, University of Murcia, and IMIB-Arrixaca, Murcia, Spain.'}, {'ForeName': 'Paulo H', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Sydney, NSW, 2050, Australia.'}]",Pilot and feasibility studies,['10.1186/s40814-022-01087-z']
1988,35702280,"Effects of propolis supplementation on irritable bowel syndrome with constipation (IBS-C) and mixed (IBS-M) stool pattern: A randomized, double-blind clinical trial.","Background


Recent evidence indicates that propolis can modulate gastrointestinal (GI) function. This trial aims to assess the efficacy of propolis supplementation on the severity of irritable bowel syndrome (IBS) symptoms.
Methods


This clinical trial was conducted on 56 subjects with IBS diagnosed by Rome IV criteria. Eligible subjects were randomly assigned to receive either 900 mg/day of propolis or matching placebo tablets for 6 weeks. The IBS symptom severity scale (IBS-SSS) was used to evaluate IBS severity in five clinically applicable items.
Results


After adjusting anxiety scores, a significant reduction was observed in the overall score of IBS symptoms (-98.27 ± 105.44), the severity of abdominal pain (-24.75 ± 28.66), and the frequency of abdominal pain (-2.24 ± 3.51) with propolis treatment as compared to placebo ( p -value < .05). Patients in the propolis group were 6.22 times more likely to experience improvement in IBS symptoms than those in the placebo group (95% CI: 1.14-33.9;  p -value: .035). There was no significant change in anthropometric measurements and dietary intakes in both groups ( p -value > .05).
Conclusions


Our results showed that propolis supplementation might have a beneficial effect on constipation subtype of IBS (IBS-C) and mixed subtype of IBS (IBS-M) severity by reducing the severity and frequency of abdominal pain in patients with irritable bowel syndrome (IBS).",2022,"There was no significant change in anthropometric measurements and dietary intakes in both groups ( p -value > .05).
","['patients with irritable bowel syndrome (IBS', 'irritable bowel syndrome with constipation (IBS-C) and mixed (IBS-M) stool pattern', '56 subjects with IBS diagnosed by Rome IV criteria', 'Eligible subjects']","['900\xa0mg/day of propolis or matching placebo tablets', 'propolis supplementation', 'placebo']","['constipation subtype of IBS (IBS-C) and mixed subtype of IBS (IBS-M) severity', 'IBS symptoms', 'frequency of abdominal pain', 'irritable bowel syndrome (IBS) symptoms', 'overall score of IBS symptoms', 'anthropometric measurements and dietary intakes', 'severity of abdominal pain', 'IBS severity', 'IBS symptom severity scale (IBS-SSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}]",56.0,0.483174,"There was no significant change in anthropometric measurements and dietary intakes in both groups ( p -value > .05).
","[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Miryan', 'Affiliation': 'Student Research Committee Tabriz University of Medical Sciences Tabriz Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Soleimani', 'Affiliation': 'Research Center of Oils and Fats Kermanshah University of Medical Sciences Kermanshah Iran.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Hepatology Department School of Medicine Jundishapur University of Medical Sciences Ahvaz Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Abbaspour', 'Affiliation': 'Targeted Drug Delivery Research Center Pharmaceutical Technology Institute Mashhad University of Medical Sciences Mashhad Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center Department of Clinical Nutrition School of Nutrition and Food Sciences Tabriz University of Medical Sciences Tabriz Iran.'}]",Food science & nutrition,['10.1002/fsn3.2806']
1989,35702121,The effect of cold therapy combined with ERAS in the postoperative care of patients undergoing total knee arthroplasty.,"OBJECTIVE


To investigate the nursing effect of cold therapy combined with enhanced recovery after surgery (ERAS) in patients undergoing total knee arthroplasty (TKA).
METHODS


Eighty patients with knee osteoarthritis who underwent TKA in our hospital from August 2020 to January 2021 were enrolled in this study, and they were divided into a control group (n=40) and a study group (n=40) according to the nursing procedures. The time and cost of rehabilitation, pain level, recovery of knee function, incidence of postoperative complications, self-care ability, quality of life, and nursing satisfaction were compared between the two groups.
RESULTS


The time of rehabilitation and time to out-of-bed activities in the study group were significantly shorter than those in the control group ( P  < 0.05), and the cost of rehabilitation in the study group was significantly lower than that in the control group ( P  < 0.05). There was no significant difference in preoperative visual analogue scale (VAS) scores (at rest, during exercise) between the two groups ( P  > 0.05). These scores in the study group were significantly lower than those in the control group at 6 h, 24 h, 48 h, and 72 h postoperatively ( P  < 0.05). The preoperative Hospital for Special Surgery (HSS), range of motion (ROM) and Barthel scores did not differ significantly between the two groups ( P  > 0.05). The postoperative ROM and Barthel scores were decreased to the lowest at 3 d postoperatively and gradually increased with time, and the HSS, ROM and Barthel scores in the study group were significantly higher than those in the control group ( P  < 0.05). The incidence of postoperative complications in the study group was significantly lower than those in the control group, and overall nursing satisfaction in the study group was significantly higher than those in the control group ( P  < 0.05). After discharge, the SF-36 scores of patients in both groups were higher than those before surgery, and the SF-36 scores in the study group were significantly higher than those in the control group ( P  < 0.05).
CONCLUSION


The cold therapy combined with ERAS for patients undergoing TKA can improve the postoperative swelling and pain of the affected limb, inspire patients' autonomy in postoperative rehabilitation training, shorten the time to out-of-bed activity, prevent patients from developing venous thrombosis, promote recovery of knee function, and improve patients' postoperative self-care ability and quality of life.",2022,"The incidence of postoperative complications in the study group was significantly lower than those in the control group, and overall nursing satisfaction in the study group was significantly higher than those in the control group ( P  < 0.05).","['Eighty patients with knee osteoarthritis who underwent TKA in our hospital from August 2020 to January 2021 were enrolled in this study, and they were divided into a control group (n=40) and a study group (n=40) according to the nursing procedures', 'patients undergoing total knee arthroplasty', 'patients undergoing', 'patients undergoing total knee arthroplasty (TKA']","['cold therapy combined with enhanced recovery after surgery (ERAS', 'cold therapy combined with ERAS', 'TKA']","['postoperative ROM and Barthel scores', 'SF-36 scores', 'HSS, ROM and Barthel scores', ""patients' postoperative self-care ability and quality of life"", 'time and cost of rehabilitation, pain level, recovery of knee function, incidence of postoperative complications, self-care ability, quality of life, and nursing satisfaction', 'incidence of postoperative complications', 'time of rehabilitation and time to out-of-bed activities', 'overall nursing satisfaction', 'preoperative Hospital for Special Surgery (HSS), range of motion (ROM) and Barthel scores', 'preoperative visual analogue scale (VAS) scores', 'cost of rehabilitation', 'postoperative swelling and pain']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204636', 'cui_str': 'Nursing procedure'}]","[{'cui': 'C0010412', 'cui_str': 'Cold therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",80.0,0.0574541,"The incidence of postoperative complications in the study group was significantly lower than those in the control group, and overall nursing satisfaction in the study group was significantly higher than those in the control group ( P  < 0.05).","[{'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'Orthopedics, Huzhou Central Hospital & Affiliated Central Hospital Huzhou University Huzhou 313000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Orthopedics, Huzhou Central Hospital & Affiliated Central Hospital Huzhou University Huzhou 313000, China.'}]",American journal of translational research,[]
1990,35702113,Ipratropium bromide and noninvasive ventilation treatment for COPD.,"OBJECTIVE


To explore the effects of ipratropium bromide combined with non-invasive ventilation for patients with both chronic obstructive pulmonary disease (COPD) and respiratory failure.
METHODS


A total of 110 patients with both COPD and respiratory failure who were admitted to our hospital from April 2018 to August 2019 were enrolled in this study; of which 52 patients were treated with a noninvasive ventilator as Group A, and the rest were treated with ipratropium bromide combined with noninvasive ventilation as Group B. The two groups were compared for blood gas indexes, pulmonary function, and treatment efficacy, and adverse reactions.
RESULTS


After treatment, Group B showed better blood gas indexes and pulmonary function than Group A (both  P  < 0.05), and Group B also showed significantly lower levels of inflammatory factors than Group A ( P  < 0.05). In addition, the efficacy and life quality of Group B were better than those of Group A, and adverse reactions of Group B were less than those of Group A (all  P  < 0.05).
CONCLUSION


Ipratropium bromide combined with noninvasive ventilation is effective in the treatment of patients with both COPD and respiratory failure.",2022,"After treatment, Group B showed better blood gas indexes and pulmonary function than Group A (both  P  < 0.05), and Group B also showed significantly lower levels of inflammatory factors than Group A ( P  < 0.05).","['110 patients with both COPD and respiratory failure who were admitted to our hospital from April 2018 to August 2019 were enrolled in this study; of which 52 patients were treated with a', 'patients with both chronic obstructive pulmonary disease (COPD) and respiratory failure', 'patients with both COPD and respiratory failure', 'COPD']","['Ipratropium bromide and noninvasive ventilation treatment', 'noninvasive ventilator', 'ipratropium bromide combined with noninvasive ventilation as Group B', 'ipratropium bromide combined with non-invasive ventilation', 'Ipratropium bromide combined with noninvasive ventilation']","['efficacy and life quality', 'blood gas indexes and pulmonary function', 'blood gas indexes, pulmonary function, and treatment efficacy, and adverse reactions', 'levels of inflammatory factors', 'adverse reactions']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0700580', 'cui_str': 'ipratropium bromide'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",110.0,0.0431755,"After treatment, Group B showed better blood gas indexes and pulmonary function than Group A (both  P  < 0.05), and Group B also showed significantly lower levels of inflammatory factors than Group A ( P  < 0.05).","[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Fujian Provincial Hospital, Fujian Provincial Clinical Medical College, Fujian Medical University Fuzhou 350001, Fujian Provincial, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Fujian Provincial Hospital, Fujian Provincial Clinical Medical College, Fujian Medical University Fuzhou 350001, Fujian Provincial, China.'}, {'ForeName': 'Baosong', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Fujian Provincial Hospital, Fujian Provincial Clinical Medical College, Fujian Medical University Fuzhou 350001, Fujian Provincial, China.'}, {'ForeName': 'Wenxiang', 'Initials': 'W', 'LastName': 'Yue', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Fujian Provincial Hospital, Fujian Provincial Clinical Medical College, Fujian Medical University Fuzhou 350001, Fujian Provincial, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Fujian Provincial Hospital, Fujian Provincial Clinical Medical College, Fujian Medical University Fuzhou 350001, Fujian Provincial, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Fujian Provincial Hospital, Fujian Provincial Clinical Medical College, Fujian Medical University Fuzhou 350001, Fujian Provincial, China.'}]",American journal of translational research,[]
1991,35702102,Correlation of ApoE gene polymorphism with acute myocardial infarction and aspirin resistance after percutaneous coronary intervention.,"OBJECTIVE


To determine the correlation of Apolipoprotein E (ApoE) gene polymorphism with acute myocardial infarction (AMI) and aspirin (APC) resistance after percutaneous coronary intervention (PCI).
METHODS


In this randomized controlled trial (The Second People's Hospital of Lianyungang Ethics Committee No.L1719), a total of 120 AMI patients admitted to the Second People's Hospital of Lianyungang from January 2019 to June 2020 were enrolled into the research group (Res group) and 120 healthy individuals during the same time period into the control group (Con group). ApoE gene polymorphism was detected by gene microarray and analyzed statistically. The occurrence of APC resistance after PCI was recorded, and the relationship between ApoE gene polymorphism and APC resistance was analyzed.
RESULTS


The Res group showed a significantly lower level of ε3/ε3 gene and significantly higher levels of ε3/ε4 and ε4/ε4 genes than the Con group (all P<0.05), but no notable difference was found in the distribution of ApoE ε2 between the two groups (P>0.05). ApoE ε3 carriers were the main carriers in both groups. However, the Res group showed a lower frequency of ApoE ε3 and a higher frequency of ApoE ε4 compared to the Con group (both P<0.05), and patients with more severe AMI had a significantly higher frequency of ApoE ε4 genotype (P<0.05). According to logistic regression analysis, carrying ApoE ε4 allele (ε3/ε4, ε4/ε4) was a risk factor for AMI (P<0.05). Additionally, patients with APC resistance had a significantly higher frequency of ApoE ε4 allele than those without it (P<0.05). A higher frequency of ApoE ε4 allele was also a risk factor of APC resistance in AMI patients after PCI, and its adjusted risk ratio (OR) was 2.26 times (P<0.05). Moreover, no significant difference was observed among patients with different ApoE genotypes in the incidence of adverse events (P>0.05).
CONCLUSION


ApoE gene polymorphism is correlated with AMI and APC resistance after PCI, and ApoE ε4 genotype is probably the risk allele for AMI.",2022,"The Res group showed a significantly lower level of ε3/ε3 gene and significantly higher levels of ε3/ε4 and ε4/ε4 genes than the Con group (all P<0.05), but no notable difference was found in the distribution of ApoE ε2 between the two groups (P>0.05).","[""120 AMI patients admitted to the Second People's Hospital of Lianyungang from January 2019 to June 2020 were enrolled into the research group (Res group) and 120 healthy individuals during the same time period into the control group (Con group""]",[],"['AMI and APC resistance', 'Apolipoprotein E (ApoE) gene polymorphism with acute myocardial infarction (AMI) and aspirin (APC) resistance', 'risk factor of APC resistance', 'occurrence of APC resistance', 'adjusted risk ratio ']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0600433', 'cui_str': 'Resistance to activated protein C due to Factor V Leiden'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",120.0,0.0609006,"The Res group showed a significantly lower level of ε3/ε3 gene and significantly higher levels of ε3/ε4 and ε4/ε4 genes than the Con group (all P<0.05), but no notable difference was found in the distribution of ApoE ε2 between the two groups (P>0.05).","[{'ForeName': 'Luoqing', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiovascular Medicine, Lianyungang Second People's Hospital Affiliated to Bengbu Medical College Lianyungang 222006, Jiangsu, China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Shao', 'Affiliation': ""Department of Cardiovascular Medicine, Lianyungang Second People's Hospital Affiliated to Bengbu Medical College Lianyungang 222006, Jiangsu, China.""}, {'ForeName': 'Cuimin', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': ""Department of Cardiovascular Medicine, Lianyungang Second People's Hospital Affiliated to Bengbu Medical College Lianyungang 222006, Jiangsu, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Cardiovascular Medicine, Lianyungang Second People's Hospital Affiliated to Bengbu Medical College Lianyungang 222006, Jiangsu, China.""}, {'ForeName': 'Feixiang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiovascular Medicine, Lianyungang Second People's Hospital Affiliated to Bengbu Medical College Lianyungang 222006, Jiangsu, China.""}, {'ForeName': 'Yilian', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiovascular Medicine, Lianyungang Second People's Hospital Affiliated to Bengbu Medical College Lianyungang 222006, Jiangsu, China.""}, {'ForeName': 'Junping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Electrocardiogram, Lianyungang Second People's Hospital Affiliated to Bengbu Medical College Lianyungang 222006, Jiangsu, China.""}]",American journal of translational research,[]
1992,35702098,Correlation between salivary HBD-2 and LL-37 expression levels with blood glucose and periodontal status in patients with type 2 diabetes mellitus.,"OBJECTIVE


To examine the correlation between salivary human β defensin-2 (HBD-2) and LL-37 expression levels and blood glucose in relationship to periodontal status in patients with type 2 diabetes mellitus (T2DM).
METHODS


The trial is available at: https://clinicaltrials.gov/ with ClinicalTrials.gov Identifier: NCT03512675. A total of 89 patients with T2DM with chronic periodontitis (CP) enrolled in our hospital from January 2020 to December 2020 were selected. According to the degree of glycemic control and CP, the patients were randomly divided into four groups, namely the good glycemic control and mild CP group (n=26), good glycemic control with moderate to severe CP group (n=24), poor glycemic control with mild CP group (n=21), and poor glycemic control with moderate to severe CP group (n=18). The periodontal clinical parameters, blood glucose indicators, and saliva HBD-2 and LL-37 expression levels were determined.
RESULTS


The expression levels of HBD-2 and LL-37 in the saliva of T2DM patients with moderate to severe CP and poor blood sugar control were significantly increased (P<0.05). Saliva HBD-2 and LL-37 levels were positively correlated with probing depth, clinical attachment loss, plaque index, and glycosylated hemoglobin. There was a synergistic interaction between blood glucose, periodontal status, and saliva HBD-2, LL-37 levels (P<0.05).
CONCLUSION


There is a positively correlated relationship between blood glucose and periodontal status with salivary HBD-2 and LL-37 levels.",2022,"Saliva HBD-2 and LL-37 levels were positively correlated with probing depth, clinical attachment loss, plaque index, and glycosylated hemoglobin.","['group (n=21), and poor glycemic control with moderate to severe CP group (n=18', '89 patients with T2DM with chronic periodontitis (CP) enrolled in our hospital from January 2020 to December 2020 were selected', 'patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['blood glucose', 'good glycemic control and mild CP group (n=26), good glycemic control with moderate to severe CP group (n=24), poor glycemic control with mild CP']","['periodontal clinical parameters, blood glucose indicators, and saliva HBD-2 and LL-37 expression levels', 'Saliva HBD-2 and LL-37 levels', 'blood sugar control', 'synergistic interaction between blood glucose, periodontal status, and saliva HBD-2, LL-37 levels (P<0.05', 'expression levels of HBD-2 and LL-37', 'probing depth, clinical attachment loss, plaque index, and glycosylated hemoglobin', 'blood glucose and periodontal status with salivary HBD-2 and LL-37 levels']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",89.0,0.0300038,"Saliva HBD-2 and LL-37 levels were positively correlated with probing depth, clinical attachment loss, plaque index, and glycosylated hemoglobin.","[{'ForeName': 'Zunsheng', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': 'Department of Stomatology, Cangzhou Central Hospital Hebei, China.'}, {'ForeName': 'Wencui', 'Initials': 'W', 'LastName': 'Ding', 'Affiliation': 'The First Department of Endocrine Diabetes, Cangzhou Central Hospital Cangzhou, Hebei, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Department of Clinical Laboratory, Cangzhou Central Hospital Hebei, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ge', 'Affiliation': 'Department of Stomatology, Cangzhou Central Hospital Hebei, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Stomatology, Cangzhou Central Hospital Hebei, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Stomatology, Cangzhou Central Hospital Hebei, China.'}, {'ForeName': 'Sumin', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Stomatology, Cangzhou Central Hospital Hebei, China.'}]",American journal of translational research,[]
1993,35702095,Clinical effect of trans-areolar resection and minimally invasive mammotome biopsy in the treatment of breast fibroadenoma and its impact on the quality of life of patients.,"OBJECTIVE


To explore the effects of trans-areolar resection and minimally invasive mammotome biopsy on therapeutic effect.
METHODS


A total of 131 patients with breast fibroadenoma were selected as the research subjects. Among them, 58 patients were treated by trans-areolar resection and included in group A (GA), and 73 patients were treated by minimally invasive mammotome biopsy and included in group B (GB). The changes of blood pressure, intraoperative blood loss and incision length in patients were detected before anesthesia, during resection and after operation. The pain score and operation time of patients were analyzed. The incidence of postoperative complications and the therapeutic effect were compared in the two groups. The Vancouver Scar Scale (VSS) was used to assess scar condition of patients in the two groups, and the lower the score, the more normal the skin. After operation, the satisfaction with breast appearance was assessed, and the quality of life was compared between the two groups.
RESULTS


During resection, DBP and SBP indexes of blood pressure in GA were lower than GB . The intraoperative blood loss in GA was greater than GB, and the incision length was also greater than GB. The VAS pain score in GA was higher than GB (P<0.05), and operation time was also longer than GB. The incidence of complications in GB was significantly lower than GA. The total effective rate in GB was significantly higher than GA. The scar score in GA was significantly higher than GB. The satisfaction in GB was significantly higher than GA, and the quality of life in GB was higher than GA. All P<0.05.
CONCLUSION


Compared with trans-areolar resection, minimally invasive mammotome biopsy has a better therapeutic effect on patients with breast fibroadenoma, and it can improve their quality of life more significantly.",2022,"The VAS pain score in GA was higher than GB (P<0.05), and operation time was also longer than GB.","['patients with breast fibroadenoma', '58 patients were treated by trans-areolar resection and included in group A (GA), and 73 patients were treated by', '131 patients with breast fibroadenoma were selected as the research subjects']","['minimally invasive mammotome biopsy', 'trans-areolar resection and minimally invasive mammotome biopsy', 'trans-areolar resection']","['total effective rate in GB', 'intraoperative blood loss in GA', 'pain score and operation time', 'operation time', 'satisfaction in GB', 'postoperative complications', 'quality of life', 'blood pressure, intraoperative blood loss and incision length', 'incidence of complications in GB', 'scar score in GA', 'quality of life in GB', 'DBP and SBP indexes of blood pressure in GA', 'Vancouver Scar Scale (VSS', 'VAS pain score', 'incision length', 'satisfaction with breast appearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178421', 'cui_str': 'Fibroadenoma of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1286082', 'cui_str': 'Appearance of breast'}]",131.0,0.0134743,"The VAS pain score in GA was higher than GB (P<0.05), and operation time was also longer than GB.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Mammary Health Care, Liaocheng Dongchangfu Maternal and Child Health Hospital Liaocheng 252000, Shandong Province, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Ultrasound, Dongchangfu Hospital of Traditional Chinese Medicine Liaocheng 252000, Shandong Province, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Department of Ultrasound, Dongchangfu Hospital of Traditional Chinese Medicine Liaocheng 252000, Shandong Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Mammary Health Care, Liaocheng Dongchangfu Maternal and Child Health Hospital Liaocheng 252000, Shandong Province, China.'}]",American journal of translational research,[]
1994,34865892,Rural engagement in primary care for optimizing weight reduction (REPOWER): A mixed methods study of patient perceptions.,"OBJECTIVE


To report on patients' satisfaction and experience of care across three different modes of weight loss counseling.
METHODS


1407 patients with obesity in the rural Midwest were enrolled to a 2-year weight management trial through their primary care practice and assigned to one of three treatment conditions: in-clinic individual, in-clinic group, phone group counseling. Patients completed surveys assessing seven domains of satisfaction and experience of care at 6 and 24-months. Post-treatment interviews were conducted to add context to survey responses.
RESULTS


1295 (92.0%) and 1230 (87.4%) completed surveys at 6 and 24-months, respectively. Patients in phone group counseling reported lower satisfaction than patients who received in-clinic group or in-clinic individual counseling across all domains at 6-months and five out of seven domains at 24-months. Interviews revealed that patients were more satisfied when they received face-to-face counseling and had meaningful interactions with their primary care provider (PCP) about their weight.
CONCLUSION


Rural patients with obesity have higher satisfaction and experience of care when weight loss counseling is delivered in a face-to-face environment and when their PCP is involved with their treatment.
PRACTICE IMPLICATIONS


Primary care practices looking to offer weight loss treatment should consider incorporating some level of face-to-face treatment plans that involves meaningful interaction with the PCP.",2022,Patients in phone group counseling reported lower satisfaction than patients who received in-clinic group or in-clinic individual counseling across all domains at 6-months and five out of seven domains at 24-months.,"['patient perceptions', 'Rural engagement in primary care for optimizing weight reduction (REPOWER', 'Rural patients with obesity', '1407 patients with obesity in the rural Midwest were enrolled to a 2-year weight management trial through their primary care practice and assigned to one of three treatment conditions: in']","['clinic individual, in-clinic group, phone group counseling']",['lower satisfaction'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",1407.0,0.0305537,Patients in phone group counseling reported lower satisfaction than patients who received in-clinic group or in-clinic individual counseling across all domains at 6-months and five out of seven domains at 24-months.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kurz', 'Affiliation': 'University of Kansas School of Medicine, Department of Population Health, Kansas City, KS USA. Electronic address: dkurz@kumc.edu.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'McCrea-Robertson', 'Affiliation': 'University of Kansas School of Medicine, Department of Population Health, Kansas City, KS USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Nelson-Brantley', 'Affiliation': 'University of Kansas School of Nursing, Kansas City, KS USA.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Befort', 'Affiliation': 'University of Kansas School of Medicine, Department of Population Health, Kansas City, KS USA.'}]",Patient education and counseling,['10.1016/j.pec.2021.11.028']
1995,35705501,Long-Term Efficacy and Safety From an Open-Label Extension of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures.,"OBJECTIVE


Evaluate long-term efficacy (percent seizure frequency reduction and responder rates), safety, and tolerability of adjunctive cenobamate in an open-label extension (OLE) of the randomized, double-blind, placebo-controlled study.
METHODS


Patients (aged 18-70 years) with uncontrolled focal seizures despite treatment with 1-3 antiseizure medications who completed the 18-week double-blind study (n=360) could enter the OLE, where they underwent a 2-week blinded conversion to cenobamate (target dose, 300 mg/day; min/max, 50/400 mg/day).
RESULTS


Three hundred fifty-five patients were included in the OLE safety population (265 originally randomized to cenobamate, 90 originally randomized to placebo), and 354 were included in the OLE modified intent-to-treat population. As of July 2019, 58.9% (209/355) of patients were continuing cenobamate treatment and 141 had discontinued, including 16.6% (59/355) due to lack of efficacy, 8.7% (31/355) due to withdrawal by patient, and 7.6% (27/355) due to adverse events. Median (range) duration of OLE exposure was 53.9 (1.1-68.7) months. Retention rates at 12, 24, 36, and 48 months were 83%, 71%, 65%, and 62%, respectively. Median percent seizure frequency reduction over baseline increased with each 6-month OLE interval, up to 76.1% at months 43-48. Among observed patients, 16.4% (36/220) achieved 100% and 39.1% (86/220) achieved ≥90% seizure reduction during >36-48 months. Among the initial OLE mITT population, 10.2% (36/354) of patients achieved 100% and 24.3% (86/354) achieved ≥90% seizure reduction during >36-48 months. Similar to the double-blind study, adverse events (AEs) included dizziness, somnolence, fatigue, and headache. Serious AEs occurred in 20.3% (72/355) of patients.
CONCLUSION


Long-term efficacy, including 100% and ≥90% seizure reduction, was sustained during 48 months of cenobamate treatment, with 71% retention at 24 months. No new safety issues were identified. These results confirm the findings of the double-blind study and support the potential long-term clinical benefit of cenobamate.
REGISTRATION


ClinicalTrials.gov NCT01866111.
CLASSIFICATION OF EVIDENCE


This study provides Class IV evidence that oral Cenobamate 50-400 mg/day is effective as an adjunctive treatment for the long-term management of patients with uncontrolled focal seizures previously treated with 1 to 3 ASMs.",2022,"Median percent seizure frequency reduction over baseline increased with each 6-month OLE interval, up to 76.1% at months 43-48.","['Patients With Uncontrolled Focal Seizures', 'patients with uncontrolled focal seizures previously treated with 1 to 3 ASMs', 'Three hundred fifty-five patients were included in the OLE safety population (265 originally randomized to cenobamate, 90 originally randomized to placebo), and 354 were included in the OLE modified intent-to-treat population', 'Patients (aged 18-70 years) with uncontrolled focal seizures despite treatment with 1-3 antiseizure medications who completed the 18-week double-blind study (n=360) could enter the']","['OLE', 'placebo']","['adverse events', 'Median (range) duration of OLE exposure', 'Serious AEs', 'Efficacy and Safety', 'adverse events (AEs) included dizziness, somnolence, fatigue, and headache', 'Median percent seizure frequency reduction', 'responder rates), safety, and tolerability of adjunctive cenobamate', 'Retention rates', 'seizure reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0242536', 'cui_str': 'Eastern Samoa'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}]",355.0,0.591506,"Median percent seizure frequency reduction over baseline increased with each 6-month OLE interval, up to 76.1% at months 43-48.","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA kleinp@epilepsydc.com.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Aboumatar', 'Affiliation': 'Austin Epilepsy Care Center, Austin, TX, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Mara Hospital, Bielefeld, Germany.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'SK Life Science, Inc., Paramus, NJ, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mizne', 'Affiliation': 'MedVal Scientific Information Services, Princeton, NJ, USA.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Sanchez-Alvarez', 'Affiliation': 'Unidad de Epilepsia, Hospital Vithas la Salud, Granada, Spain.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Center, Kehl-Kork, Germany.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Villanueva', 'Affiliation': 'Refractory Epilepsy Unit, Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}]",Neurology,['10.1212/WNL.0000000000200792']
1996,35705423,Renal Function in Patients Hospitalized With Anorexia Nervosa Undergoing Refeeding: Findings From the Study of Refeeding to Optimize Inpatient Gains.,"PURPOSE


Among complications of malnutrition secondary to anorexia nervosa (AN) or atypical anorexia nervosa (AAN), renal impairment remains poorly elucidated. Evaluating renal function in hospitalized pediatric patients with AN and AAN undergoing refeeding will yield important information to guide clinicians in screening and managing renal dysfunction in this population.
METHODS


This is a secondary analysis of data from the Study of Refeeding to Optimize Inpatient Gains trial, a multicenter randomized clinical trial comparing higher calorie refeeding versus lower calorie refeeding in 120 adolescents and young adults hospitalized with medical instability secondary to AN or AAN. Baseline disease characteristics were obtained. Vital sign measurements, weight, electrolytes, and fluid status were evaluated daily to ascertain medical stability. Renal function on admission and throughout hospitalization was quantified using daily creatinine measurement and calculation of the estimated glomerular filtration rate (eGFR) using the modified Schwartz equation. Regression analysis and mixed linear models were utilized to evaluate factors associated with eGFR.
RESULTS


Of the 111 participants who completed treatment protocol, 33% had a baseline eGFR less than 90, suggesting renal impairment. Patients who experienced more rapid weight loss and more severe bradycardia were more likely to have low admission eGFR. While eGFR improved during refeeding, eGFR change by day based on refeeding treatment assignment did not reach statistical significance (95% confidence interval, -1.61, 0.15]; p = .095).
DISCUSSION


Renal impairment is evident on admission in a significant number of adolescents and young adults hospitalized with AN and AAN. We demonstrate that short-term medical refeeding yields improvement in renal function.",2022,"While eGFR improved during refeeding, eGFR change by day based on refeeding treatment assignment did not reach statistical significance (95% confidence interval, -1.61, 0.15]; p = .095).
","['hospitalized pediatric patients with AN and AAN undergoing refeeding', 'adolescents and young adults hospitalized with AN and AAN', 'Patients Hospitalized With Anorexia Nervosa Undergoing Refeeding', '111 participants who completed treatment protocol', '120 adolescents and young adults hospitalized with medical instability secondary to AN or AAN']",['calorie refeeding versus lower calorie refeeding'],"['Renal function on admission and throughout hospitalization', 'renal function', 'Vital sign measurements, weight, electrolytes, and fluid status', 'severe bradycardia', 'rapid weight loss', 'Renal Function']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",120.0,0.0724276,"While eGFR improved during refeeding, eGFR change by day based on refeeding treatment assignment did not reach statistical significance (95% confidence interval, -1.61, 0.15]; p = .095).
","[{'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Downey', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco, California; Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, California. Electronic address: amanda.downey@ucsf.edu.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Department of Preventive and Restorative Dental Sciences, University of California, San Francisco, California.'}, {'ForeName': 'Sally H', 'Initials': 'SH', 'LastName': 'Adams', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco, California.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Buckelew', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco, California.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Kapphahn', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Palo Alto, California.'}, {'ForeName': 'Vanessa I', 'Initials': 'VI', 'LastName': 'Machen', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco, California.'}, {'ForeName': 'Elaine L', 'Initials': 'EL', 'LastName': 'Rosen', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, Los Angeles, California.'}, {'ForeName': 'Anna-Barbara', 'Initials': 'AB', 'LastName': 'Moscicki', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, Los Angeles, California.'}, {'ForeName': 'Neville H', 'Initials': 'NH', 'LastName': 'Golden', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Palo Alto, California.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Garber', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco, California.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2022.04.017']
1997,35705913,Risk of selection bias assessment in the NINDS rt-PA stroke study.,"OBJECTIVES


The NINDS rt-PA Stroke Study is frequently cited in support of alteplase for acute ischemic stroke within 3 h of symptom onset. Multiple post-hoc reanalyses of this trial have been published to adjust for a baseline imbalance in stroke severity. We performed a risk of selection bias assessment and reanalyzed trial data to determine if the etiology of this baseline imbalance was more likely due to random chance or randomization errors.
METHODS


A risk of selection bias assessment was conducted using signaling questions from the Cochrane Risk of Bias 2 (ROB 2) tool. Four sensitivity analyses were conducted on the trial data based on the randomization process: assessment of imbalances in allocation in unique strata; adherence to a pre-specified restriction on randomization between time strata at each randomization center; assessment of differences in baseline computed tomography (CT) results in unique strata; and comparison of baseline characteristics between allocation groups within each time strata. A multivariable logistic regression model was used to compare reported treatment effects with revised treatment effects after adjustment of baseline imbalances identified in the sensitivity analyses.
RESULTS


Based on criteria from the ROB 2 tool, the risk of bias arising from the randomization process was high. Sensitivity analyses found 11 of 16 unique strata deviated from the expected 1:1 allocation ratio. Three randomization centers violated an apriori rule regarding a maximum difference in allocation between the time strata. Three unique strata had imbalances in baseline CT results that prognostically favored alteplase. Four imbalances in baseline characteristics were identified in the 91-180-min time stratum that all prognostically favored alteplase and were consistent with a larger alteplase treatment effect size compared to the 0-90-min time stratum. After adjustments for baseline imbalances, all reported treatment effects were reduced. Three out of seven originally positive reported results were revised to non-significant.
CONCLUSION


This risk of selection bias assessment revealed a high risk of selection bias in the NINDS rt-PA Stroke Study. Sensitivity analyses conducted based on the randomization process supported this assessment. Baseline imbalances in the trial were more likely due to randomization errors than random chance. Adjusted analyses accounting for baseline imbalances revealed a reduction in reported treatment effects supporting the presence of selection bias in the trial. Treatment decisions and guideline recommendations based on the original treatment effect reported in the NINDS rt-PA Stroke Study should be done cautiously.",2022,Adjusted analyses accounting for baseline imbalances revealed a reduction in reported treatment effects supporting the presence of selection bias in the trial.,[],[],[],[],[],[],,0.1338,Adjusted analyses accounting for baseline imbalances revealed a reduction in reported treatment effects supporting the presence of selection bias in the trial.,"[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Department of Neurology, Division of Neurocritical Care, Loyola University Chicago Stritch School of Medicine, 2160 S First Avenue, Maywood, IL, 60153, USA. ravigarg@lumc.edu.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Mickenautsch', 'Affiliation': 'Faculty of Dentistry, University of the Western Cape, Francie van Zijl Avenue, Tygerberg, Cape Town, 7505, South Africa.'}]",BMC medical research methodology,['10.1186/s12874-022-01651-4']
1998,35705887,"Opicapone as an Add-on to Levodopa in Patients with Parkinson's Disease Without Motor Fluctuations: Rationale and Design of the Phase III, Double-Blind, Randomised, Placebo-Controlled EPSILON Trial.","INTRODUCTION


Levodopa remains the cornerstone treatment for Parkinson's disease (PD) but its use is associated with the development of 'wearing-off' fluctuations and other motor and non-motor complications over time. Adding a catechol-O-methyltransferase (COMT) inhibitor to levodopa/dopa decarboxylase (DDC) inhibitor therapy reduces fluctuations in the profile of plasma levodopa levels following oral dosing, and can therefore be beneficial for the management of motor complications. The objective of the EPSILON study is to investigate the efficacy of opicapone (OPC; a third-generation, once-daily COMT inhibitor) in enhancing the clinical benefit of levodopa in patients in earlier stages of PD, without end-of-dose motor fluctuations.
METHODS


EPSILON is a phase III, double-blind, randomised, placebo-controlled and parallel-group study, designed to evaluate the efficacy and safety of OPC as add-on to levodopa/DDC inhibitor therapy in patients with early PD who do not exhibit signs of motor complications. Eligible patients will be randomised (1:1) to receive OPC 50 mg or placebo, in addition to their existing levodopa/DDC inhibitor therapy, over a 24-week, double-blind treatment period, after which they will have the option of entering an additional 1-year, open-label extension period, during which all patients will receive OPC 50 mg.
PLANNED OUTCOMES


The primary efficacy endpoints are change in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score from baseline to the end of the double-blind period (double-blind phase) and change in MDS-UPDRS Part IV total score from open-label baseline to the end of the open-label period (open-label phase). Secondary outcomes during the double-blind phase will include other measures of PD symptoms, including quality of life, non-motor symptoms, and development of motor fluctuations. Safety assessments will include evaluation of treatment-emergent adverse events, laboratory safety parameters, suicidality and impulse control disorders.
TRIAL REGISTRATION


European Union Drug Regulating Authorities Clinical Trials Database (number 2020-005011-52).",2022,The primary efficacy endpoints are change in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS),"['Eligible patients', 'patients with early PD who do not exhibit signs of motor complications', ""Parkinson's disease (PD"", 'patients in earlier stages of PD, without end-of-dose motor fluctuations', ""Patients with Parkinson's Disease Without Motor Fluctuations""]","['catechol-O-methyltransferase (COMT) inhibitor to levodopa/dopa decarboxylase (DDC) inhibitor therapy', 'levodopa/DDC inhibitor therapy', 'placebo', 'OPC 50\xa0mg or placebo, in addition to their existing levodopa/DDC inhibitor therapy', 'levodopa', 'OPC', 'OPC 50\xa0mg', 'Opicapone', 'Levodopa', 'Placebo', 'opicapone (OPC']","['MDS-UPDRS Part\xa0IV total score', 'efficacy and safety', 'PD symptoms, including quality of life, non-motor symptoms, and development of motor fluctuations', ""change in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'evaluation of treatment-emergent adverse events, laboratory safety parameters, suicidality and impulse control disorders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1868976', 'cui_str': 'Motor fluctuations'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C4042618', 'cui_str': 'DDC protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0598272', 'cui_str': 'Dopa decarboxylase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2933912', 'cui_str': 'opicapone'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1868976', 'cui_str': 'Motor fluctuations'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021122', 'cui_str': 'Impulse control disorder'}]",,0.731721,The primary efficacy endpoints are change in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS),"[{'ForeName': 'Joaquim J', 'Initials': 'JJ', 'LastName': 'Ferreira', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rascol', 'Affiliation': ""Toulouse Parkinson Expert Center, Departments of Neurosciences and Clinical Pharmacology, Centre d'Investigation Clinique de Toulouse CIC1436, NS-Park/FCRIN Network, and NeuroToul COEN Center, University Hospital of Toulouse, INSERM, University of Toulouse 3, Toulouse, France.""}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Stocchi', 'Affiliation': 'Department of Neurology, University San Raffaele and IRCCS San Raffaele, Rome, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Antonini', 'Affiliation': 'Parkinson and Movement Disorders Unit, Center for Neurodegenerative Disease (CESNE), Department of Neurosciences, University of Padova, Padua, Italy.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Moreira', 'Affiliation': 'BIAL - Portela & Cª S.A., Coronado, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pereira', 'Affiliation': 'BIAL - Portela & Cª S.A., Coronado, Portugal.'}, {'ForeName': 'José-Francisco', 'Initials': 'JF', 'LastName': 'Rocha', 'Affiliation': 'BIAL - Portela & Cª S.A., Coronado, Portugal. francisco.rocha@bial.com.'}, {'ForeName': 'Patrício', 'Initials': 'P', 'LastName': 'Soares-da-Silva', 'Affiliation': 'BIAL - Portela & Cª S.A., Coronado, Portugal.'}]",Neurology and therapy,['10.1007/s40120-022-00371-7']
1999,35705886,Atogepant for the Prevention of Episodic Migraine in Adults: A Systematic Review and Meta-Analysis of Efficacy and Safety.,"INTRODUCTION


The inhibition of the calcitonin gene-related peptide (CGRP) pathway has attracted interest in pharmacological research on migraine. Atogepant is a potent, selective, orally available antagonist of the CGRP receptor approved as a preventive treatment of episodic migraine. This systematic review with meta-analysis aims to evaluate the efficacy and safety of atogepant for the prevention of episodic migraine in adult patients.
METHODS


Randomized, placebo-controlled, single or double-blinded trials were identified through a systematic literature search (December week 4, 2021). Main outcomes included the changes from baseline in monthly migraine days and the incidence of adverse events (AEs) and treatment withdrawal due to AEs. Mean difference (MD) and risk ratio (RR) with 95% confidence intervals (95% CIs) were estimated.
RESULTS


Two trials were included, overall enrolling 1550 patients. A total of 408 participants were randomized to placebo, 314 to atogepant 10 mg, 411 to atogepant 30 mg, and 417 to atogepant 60 mg once daily. The mean age of the patients was 41.0 years and 87.7% were women. The reduction in the mean number of migraine days from baseline across the 12-week treatment period was significantly greater among patients treated with atogepant at either the daily dose of 10 mg (MD - 1.16, 95% CI - 1.60 to - 0.73, p < 0.001), 30 mg (MD - 1.15, 95% CI - 1.54 to - 0.76, p < 0.001), or 60 mg (MD - 1.20, 95% CI - 2.18 to - 0.22, p = 0.016) than with placebo. There were no differences in the occurrence of AEs and drug withdrawal due to AEs between atogepant and placebo groups. Constipation was more commonly observed in patients treated with atogepant at 30 mg/day than placebo (RR 5.19, 95% CI 2.00-13.46; p = 0.001). Treatment with atogepant at the daily dose of 60 mg was associated with a higher risk of constipation (RR 4.92, 95% CI 1.89-12.79; p = 0.001) and nausea (RR 2.73, 95% CI 1.47-5.06; p = 0.001) than placebo.
CONCLUSION


Atogepant is an efficacious and overall well-tolerated treatment for the prevention of episodic migraine in adults.",2022,There were no differences in the occurrence of AEs and drug withdrawal due to AEs between atogepant and placebo groups.,"['adult patients', 'mean age of the patients was 41.0\xa0years and 87.7% were women', 'Two trials were included, overall enrolling 1550 patients', 'Adults', '408 participants']",['placebo'],"['higher risk of constipation', 'occurrence of AEs and drug withdrawal due to AEs', 'efficacy and safety', 'Mean difference (MD) and risk ratio (RR', 'Constipation', 'monthly migraine days and the incidence of adverse events (AEs) and treatment withdrawal due to AEs', 'nausea', 'mean number of migraine days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4517769', 'cui_str': '408'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038587', 'cui_str': 'Withdrawal syndrome'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1701941', 'cui_str': 'Treatment withdrawal'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",408.0,0.821223,There were no differences in the occurrence of AEs and drug withdrawal due to AEs between atogepant and placebo groups.,"[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Lattanzi', 'Affiliation': 'Department of Experimental and Clinical Medicine, Neurological Clinic, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy. alfierelattanzisimona@gmail.com.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Trinka', 'Affiliation': 'Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Altamura', 'Affiliation': 'Headache and Neurosonology Unit, Fondazione Policlinico Campus Bio-Medico of Rome, Rome, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Del Giovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Silvestrini', 'Affiliation': 'Department of Experimental and Clinical Medicine, Neurological Clinic, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Brigo', 'Affiliation': 'Division of Neurology, ""Franz Tappeiner"" Hospital, Merano, BZ, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Vernieri', 'Affiliation': 'Headache and Neurosonology Unit, Fondazione Policlinico Campus Bio-Medico of Rome, Rome, Italy.'}]",Neurology and therapy,['10.1007/s40120-022-00370-8']
2000,35705827,Effect of sacralization on the success of lumbar transforaminal epidural steroid injection treatment: prospective clinical trial.,"OBJECTIVE


The aim of this study was to invastigate the effect of the sacralization on the results of transforaminal epidural steroid injection for radicular low back pain.
MATERIALS AND METHODS


The study included 64 patients diagnosed with radicular low back pain due to unilateral and single-level lumbar disk herniation. Patients were divided into 2 groups: patients with sacralization (Group S) and patients without lumbosacral transitional vertebrae (Group A). Injection was applied to the relevant level. Patients were evaluated with Numeric Rating Scale and Modified Oswestry Disability Index before, at week 3 and month 3 after the procedure. Sacralization presence was determined by MRI. Sacralization was categorized by anteroposterior lumbar radiography using Castellvi classification. Treatment success was considered as ≥ 50% reduction in NRS scores.
RESULTS


Numeric Rating Scale and Modified Oswestry Disability Index scores decreased in both groups on both week 3 and month 3 (p < 0.05). Pain scores of Group S (median value 5 (3-6)) were significantly higher than Group A ((median value 3 (0-5)) in the third month follow-up (p = 0.026), but no significant difference was observed at other time points. There was no significant difference in Modified Oswestry Disability Index scores between the groups at all follow-ups (p > 0.05). Treatment success in the third month was 44.8% in Group S and 65.6% in Group A.
CONCLUSION


Transforaminal epidural steroid injection is an effective and safe method for radicular low back pain. Sacralization presence should be evaluated before treatment considering that it may be a risk factor reducing treatment success.",2022,"RESULTS


Numeric Rating Scale and Modified Oswestry Disability Index scores decreased in both groups on both week 3 and month 3 (p < 0.05).",['64 patients diagnosed with radicular low back pain due to unilateral and single-level lumbar disk herniation'],"['sacralization (Group S) and patients without lumbosacral transitional vertebrae', 'sacralization', 'Transforaminal epidural steroid injection', 'transforaminal epidural steroid injection']","['Pain scores', 'Modified Oswestry Disability Index scores', 'Sacralization presence', 'Numeric Rating Scale and Modified Oswestry Disability Index', 'Numeric Rating Scale and Modified Oswestry Disability Index scores', 'NRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]","[{'cui': 'C1409431', 'cui_str': 'Sacralisation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C1299890', 'cui_str': 'Transitional vertebra'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C1409431', 'cui_str': 'Sacralisation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.014536,"RESULTS


Numeric Rating Scale and Modified Oswestry Disability Index scores decreased in both groups on both week 3 and month 3 (p < 0.05).","[{'ForeName': 'Savas', 'Initials': 'S', 'LastName': 'Sencan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Division of Pain Medicine, Faculty of Medicine, Marmara University, Mimar Sinan Caddesi No:41 Üst Kaynarca, Fevzi Çakmak, Mahallesi, Pendik, Istanbul, 34906, Turkey.'}, {'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Azizov', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Division of Pain Medicine, Faculty of Medicine, Marmara University, Mimar Sinan Caddesi No:41 Üst Kaynarca, Fevzi Çakmak, Mahallesi, Pendik, Istanbul, 34906, Turkey.'}, {'ForeName': 'Alp Eren', 'Initials': 'AE', 'LastName': 'Celenlioglu', 'Affiliation': 'Department of Pain Medicine, University of Health Sciences Gulhane Training and Research Hospital, General Dr.Tevfik Sağlam Cd. No:1, Etlik, Ankara, 06010, Turkey. a.celenlioglu@gmail.com.'}, {'ForeName': 'Serhad', 'Initials': 'S', 'LastName': 'Bilim', 'Affiliation': 'Department of Pain Medicine, Adıyaman University Training and Research Hospital, Ziyaretpayamlı/Adıyaman, Merkez/Adıyaman, Turkey.'}, {'ForeName': 'Osman Hakan', 'Initials': 'OH', 'LastName': 'Gunduz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Division of Pain Medicine, Faculty of Medicine, Marmara University, Mimar Sinan Caddesi No:41 Üst Kaynarca, Fevzi Çakmak, Mahallesi, Pendik, Istanbul, 34906, Turkey.'}]",Skeletal radiology,['10.1007/s00256-022-04089-3']
2001,35705671,Running interval training combined with blood flow restriction increases maximal running performance and muscular fitness in male runners.,"We investigated the effects of 8 weeks (3 days per week) of running interval training (RIT) combined with blood flow restriction (RIT-BFR) on the maximal running performance (RPmax), isokinetic muscle strength, and muscle endurance in athletes. Twenty endurance-trained male runners were pair-matched and randomly assigned to the RIT-BFR and RIT groups. The RIT-BFR group performed RIT (50% heart rate reserve, 5 sets of 3 min each, and 1-min rest interval) with inflatable cuffs (1.3× resting systolic blood pressure), and the RIT group performed the same RIT without inflatable cuffs. RPmax, isokinetic muscle strength, and muscle endurance were assessed at pre-, mid-, and post-training. Compared with the RIT group, the RIT-BFR group exhibited a significantly (p < 0.05) greater increase in RPmax, isokinetic knee extensor and flexor strength, and knee extensor endurance after 24 training sessions. These results suggested that RIT-BFR may be a feasible training strategy for improving muscular fitness and endurance running performance in distance runners.",2022,"Compared with the RIT group, the RIT-BFR group exhibited a significantly (p < 0.05) greater increase in RPmax, isokinetic knee extensor and flexor strength, and knee extensor endurance after 24 training sessions.","['distance runners', 'Twenty endurance-trained male runners', 'male runners']","['running interval training (RIT) combined with blood flow restriction (RIT-BFR', 'RIT', 'Running interval training combined with blood flow restriction']","['RPmax, isokinetic muscle strength, and muscle endurance', 'muscular fitness and endurance running performance', 'maximal running performance and muscular fitness', 'RPmax, isokinetic knee extensor and flexor strength, and knee extensor endurance', 'maximal running performance (RPmax), isokinetic muscle strength, and muscle endurance']","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",,0.0173253,"Compared with the RIT group, the RIT-BFR group exhibited a significantly (p < 0.05) greater increase in RPmax, isokinetic knee extensor and flexor strength, and knee extensor endurance after 24 training sessions.","[{'ForeName': 'Yun-Tsung', 'Initials': 'YT', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education and Sport Sciences, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Yao-Yi', 'Initials': 'YY', 'LastName': 'Hsieh', 'Affiliation': 'Department of Physical Education and Sport Sciences, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Jen-Yu', 'Initials': 'JY', 'LastName': 'Ho', 'Affiliation': 'Department of Athletic Performance, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Chien-Chang', 'Initials': 'CC', 'LastName': 'Ho', 'Affiliation': 'Department of Physical Education, Fu Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Tung-Yi', 'Initials': 'TY', 'LastName': 'Lin', 'Affiliation': 'Institute of Traditional Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. tylin99@nycu.edu.tw.'}, {'ForeName': 'Jung-Charng', 'Initials': 'JC', 'LastName': 'Lin', 'Affiliation': 'Graduate Institute of Sport Coaching Science, Chinese Culture University, Taipei, Taiwan.'}]",Scientific reports,['10.1038/s41598-022-14253-3']
2002,35706006,"Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study.","BACKGROUND


Heart failure (HF) is a global leading cause of mortality despite implementation of guideline directed therapy which warrants a need for novel treatment strategies. Proof-of-concept clinical trials of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, have shown promising results in patients with HF.
METHOD


We designed a single center, randomized, placebo controlled, double-blind phase II randomized clinical trial. One hundred and two adult patients hospitalized within 2 weeks of discharge due to acute decompensated HF with reduced ejection fraction (HFrEF) and systemic inflammation (high sensitivity of C-reactive protein > 2 mg/L) will be randomized in 2:1 ratio to receive anakinra or placebo for 24 weeks. The primary objective is to determine the effect of anakinra on peak oxygen consumption (VO 2 ) measured at cardiopulmonary exercise testing (CPX) after 24 weeks of treatment, with placebo-corrected changes in peak VO 2  at CPX after 24 weeks (or longest available follow up). Secondary exploratory endpoints will assess the effects of anakinra on additional CPX parameters, structural and functional echocardiographic data, noninvasive hemodynamic, quality of life questionnaires, biomarkers, and HF outcomes.
DISCUSSION


The current trial will assess the effects of IL-1 blockade with anakinra for 24 weeks on cardiorespiratory fitness in patients with recent hospitalization due to acute decompensated HFrEF.
TRIAL REGISTRATION


The trial was registered prospectively with ClinicalTrials.gov on Jan 8, 2019, identifier NCT03797001.",2022,"Proof-of-concept clinical trials of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, have shown promising results in patients with HF.
","['patients with HF', 'One hundred and two adult patients hospitalized within 2\xa0weeks of discharge due to acute decompensated HF with reduced ejection fraction (HFrEF) and systemic inflammation (high sensitivity of C-reactive protein >\u20092\xa0mg/L', 'patients with recent hospitalization due to acute decompensated HFrEF']","['cardiopulmonary exercise testing (CPX', 'interleukin-1 blockade', 'placebo', 'anakinra or placebo']","['peak oxygen consumption (VO 2 ', 'effects of anakinra on additional CPX parameters, structural and functional echocardiographic data, noninvasive hemodynamic, quality of life questionnaires, biomarkers, and HF outcomes', 'cardiorespiratory fitness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",102.0,0.904616,"Proof-of-concept clinical trials of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, have shown promising results in patients with HF.
","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Van Tassell', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA. bvantassell@vcu.edu.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Mihalick', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Marawan', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Department of Pharmacotherapy and Outcome Sciences, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Division of Epidemiology, Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ladd', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Juan Ignacio', 'Initials': 'JI', 'LastName': 'Damonte', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Dave L', 'Initials': 'DL', 'LastName': 'Dixon', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Markley', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Turlington', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Federmann', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Marco Giuseppe', 'Initials': 'MG', 'LastName': 'Del Buono', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi-Zoccai', 'Affiliation': 'Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Canada', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, College of Applied Science, University of Illinois Chicago, Chicago, IL, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.'}]",Journal of translational medicine,['10.1186/s12967-022-03466-9']
2003,35705982,A study to investigate the effectiveness of the application of virtual reality technology in dental education.,"BACKGROUND


Today, the use of virtual reality (VR) technology as an educational tool in dental education has expanded considerably. This study was aimed to evaluate the effectiveness of using VR technology in teaching neutral zone and teeth arrangement.
METHODS


This randomized trial was conducted at Kermanshah University of Medical Sciences, Iran in 2019. The study sample consisted of 50 six-year dental students who were randomly divided into experimental (n = 25) and control (n = 25) groups. Students' performance in both groups was assessed using tests. A questionnaire was used to assess the usability of VR technology and students' satisfaction with it.
RESULTS


All faculty members confirmed the usability of VR technology in dental education. The majority of students (76%) were highly satisfied with the use of this technology in their learning process. The mean score of students was significantly higher in the experimental group (16.92 ± 1.12) than in the control group (16.14 ± 1.18).
CONCLUSION


In general, it can be argued that VR technology is useful and effective in the teaching-learning process. Therefore, its use in medical and dental schools can play an effective role in creating a dynamic, attractive, and successful learning environment.",2022,"The mean score of students was significantly higher in the experimental group (16.92 ± 1.12) than in the control group (16.14 ± 1.18).
","['50 six-year dental students', 'dental education', 'Kermanshah University of Medical Sciences, Iran in 2019']","['VR technology', 'virtual reality technology', 'virtual reality (VR) technology']",['mean score of students'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0013627', 'cui_str': 'Dental Education'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0115965,"The mean score of students was significantly higher in the experimental group (16.92 ± 1.12) than in the control group (16.14 ± 1.18).
","[{'ForeName': 'Meysam Siyah', 'Initials': 'MS', 'LastName': 'Mansoory', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Seyyed Mohsen', 'Initials': 'SM', 'LastName': 'Azizi', 'Affiliation': 'Medical Education and Development Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fakhrosadat', 'Initials': 'F', 'LastName': 'Mirhosseini', 'Affiliation': 'Trauma Research Center & Educational Development Center, Kashan University of Medical Sciences (KaUMS), Kashan, Iran.'}, {'ForeName': 'Danial', 'Initials': 'D', 'LastName': 'Yousefi', 'Affiliation': 'Department of Computer Engineering, Islamic Azad University of Central Tehran Branch, Tehran, Iran.'}, {'ForeName': 'Hedaiat', 'Initials': 'H', 'LastName': 'Moradpoor', 'Affiliation': 'Department of Prosthodontics, School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran. h.moradpour@kums.ac.ir.'}]",BMC medical education,['10.1186/s12909-022-03543-z']
2004,35705975,Using a multi-module web-app to prevent substance use among students at a Hispanic Serving Institution: development and evaluation design.,"BACKGROUND


Despite effective strategies to prevent substance use and substance use disorders among college students, challenges remain. As young adults' preference for and comfortability with web-based technology continues to increase, leveraging innovative approaches to rapidly evolving mHealth technology is critical for the success of lowering the risk for substance use and related consequences in college populations, and especially those at Hispanic Serving Institutions. Therefore, the present study describes the rationale, development, and design of iSTART, a novel web-app to prevent substance use among students.
METHODS


The web-app was developed following the intervention mapping protocol, and in collaboration with numerous stakeholders, including a community-based partner specializing in substance abuse prevention and treatment. A 30-day multi-module web-app intervention was developed based on key theoretical constructs, behavior change strategies, and practical module components: attitudes (knowledge), perceived susceptibility (risk perceptions), subjective norms (normative re-education), and self-efficacy (refusal skills). This intervention will be evaluated via a time series design using a sample of 600 students randomly assigned to either the intervention, comparison, or control condition at a public institution in southern California.
DISCUSSION


The iSTART web-app is an innovative and sustainable program ideal for college campuses with diverse student populations. If this prevention web-app is successful, it will significantly contribute to the evidence of effective substance use interventions in the college setting, and identify the benefits of mHealth programs to prevent future substance use.
TRIAL REGISTRATION


NCT05362357 retrospectively registered on May 4, 2022 on clinicaltrials.gov .",2022,"As young adults' preference for and comfortability with web-based technology continues to increase, leveraging innovative approaches to rapidly evolving mHealth technology is critical for the success of lowering the risk for substance use and related consequences in college populations, and especially those at Hispanic Serving Institutions.","['600 students randomly assigned to either the intervention, comparison, or control condition at a public institution in southern California', 'college campuses with diverse student populations', 'college students']",[],"['susceptibility (risk perceptions), subjective norms (normative re-education), and self-efficacy (refusal skills']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}]",600.0,0.0140266,"As young adults' preference for and comfortability with web-based technology continues to increase, leveraging innovative approaches to rapidly evolving mHealth technology is critical for the success of lowering the risk for substance use and related consequences in college populations, and especially those at Hispanic Serving Institutions.","[{'ForeName': 'Bethany K W', 'Initials': 'BKW', 'LastName': 'Rainisch', 'Affiliation': 'Department of Health Sciences, California State University, Northridge, 18111 Nordhoff St., Northridge, CA, 91330, USA. Bethany.rainisch@csun.edu.'}, {'ForeName': 'Linn', 'Initials': 'L', 'LastName': 'Dahlman', 'Affiliation': 'Department of Health Sciences, California State University, Northridge, 18111 Nordhoff St., Northridge, CA, 91330, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Vigil', 'Affiliation': 'Department of Health Sciences, California State University, Northridge, 18111 Nordhoff St., Northridge, CA, 91330, USA.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Forster', 'Affiliation': 'Department of Health Sciences, California State University, Northridge, 18111 Nordhoff St., Northridge, CA, 91330, USA.'}]",BMC public health,['10.1186/s12889-022-13428-x']
2005,35705944,Morphine versus methadone for neonatal opioid withdrawal syndrome: a randomized controlled pilot study.,"BACKGROUND


Neonatal Opioid Withdrawal Syndrome (NOWS) is a significant public health issue and while millions of neonates are affected each year, an optimal pharmacologic weaning protocol has yet to be demonstrated. In this study, we compare hospital length of stay (LOS) and length of treatment (LOT) for treatment of neonatal opioid withdrawal (NOWS) with morphine versus methadone.
METHODS


This was a single-site, open-label, randomized controlled pilot study conducted from October 2016-September 2018. Infants were eligible if their primary in-utero drug exposure was heroin, oral opioids, or methadone and they were born at greater than or equal to 34 weeks gestation. Infants were excluded for serious medical comorbidities and primary in-utero exposure to buprenorphine.
RESULTS


Sixty-one infants were enrolled; 30 were randomized to methadone treatment, and 31 to morphine treatment. Overall 46% of infants required treatment for NOWS. LOS and LOT for infants treated with morphine was 17.9 days and 14.7 days respectively, compared to 16.1 days and 12.8 days for babies treated with methadone (p = 0.5, p = 0.54). Infants treated with morphine received lower total morphine equivalents than those treated with methadone (9.7 vs. 33, p < 0.01). Three treated infants in the methadone group required transfer to the Neonatal Intensive Care Unit, versus no infants in the morphine group.
CONCLUSIONS


Infants treated with morphine versus methadone had no significant differences in LOS or LOT in this pilot study. Infants treated with methadone received up to 3 times the opioid based on morphine equivalents as infants treated with morphine and had more transfers to the NICU for over sedation.
CLINICAL TRIAL REGISTRATION


Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome NCT02851303 , initiated 01/08/2016.",2022,"Infants treated with morphine received lower total morphine equivalents than those treated with methadone (9.7 vs. 33, p < 0.01).","['Sixty-one infants were enrolled; 30', 'Infants were eligible if their primary in-utero drug exposure was heroin, oral opioids, or methadone and they were born at greater than or equal to 34\xa0weeks gestation', 'neonatal opioid withdrawal syndrome']","['Morphine Versus Methadone', 'methadone', 'morphine', 'morphine versus methadone', 'buprenorphine', 'Morphine']","['total morphine equivalents', 'LOS', 'transfer to the Neonatal Intensive Care Unit', 'LOS and LOT', 'hospital length of stay (LOS) and length of treatment (LOT']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857808', 'cui_str': 'Drug exposure in utero'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",61.0,0.0442912,"Infants treated with morphine received lower total morphine equivalents than those treated with methadone (9.7 vs. 33, p < 0.01).","[{'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Sutter', 'Affiliation': 'Department of Family Medicine, Alpert Medical School of Brown University, Providence, RI, USA. marybeth_sutter@brown.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Watson', 'Affiliation': 'Santa Rosa Community Health, Santa Rosa, CA, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Yonke', 'Affiliation': 'Family Medicine of Southwest Washington, Vancouver, WA, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Weitzen', 'Affiliation': 'Baystate Health, Springfield, MA, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Leeman', 'Affiliation': 'Department of Family and Community Medicine, Department of Obstetrics, University of New Mexico, Albuquerque, NM, USA.'}]",BMC pediatrics,['10.1186/s12887-022-03401-3']
2006,35705934,Care engagement with healthcare providers and symptom management self-efficacy in women living with HIV in China: secondary analysis of an intervention study.,"BACKGROUND


Symptom management self-efficacy is a prerequisite for individuals to fully manage their symptoms. The literature reports associations between engagement with healthcare providers (HCPs), internalized stigma, and types of self-efficacy other than symptom management. However, the factors of symptom management self-efficacy are not well understood. This study aimed to investigate the relationship among engagement with HCPs, internalized stigma, and HIV symptom management self-efficacy in Chinese women living with HIV (WLWH).
METHODS


This current analysis was part of the original randomized control trial, we used data collected from 41 women living with HIV (WLWH) assigned to an intervention arm or a control arm from Shanghai and Beijing, China, at baseline, Week 4 and Week 12. The CONSORT checklist was used. The study was registered in the Clinical Trial Registry (#NCT03049332) on 10/02/2017.
RESULTS


The results demonstrate that HCPs should increase engagement with WLWH when providing care, thereby improving their symptom management self-efficacy. The results suggested that participants' engagement with HCPs was significantly positively correlated with their HIV symptom management self-efficacy in the latter two time points. Internalized stigma was significantly negatively correlated with HIV symptom management self-efficacy only at the 4-week follow-up.
CONCLUSIONS


This study demonstrated the positive effect of engagement with HCPs on WLWHs' symptom management self-efficacy as well as the negative effect of internalized stigma on symptom management self-efficacy. Future research can further test the relationship between the three key concepts, as well as explore interventions to decrease internalized stigma.",2022,The results suggested that participants' engagement with HCPs was significantly positively correlated with their HIV symptom management self-efficacy in the latter two time points.,"['women living with HIV in China', 'Chinese women living with HIV (WLWH', '41 women living with HIV (WLWH']",['HCPs'],"['Internalized stigma', 'HIV symptom management self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",41.0,0.0510395,The results suggested that participants' engagement with HCPs was significantly positively correlated with their HIV symptom management self-efficacy in the latter two time points.,"[{'ForeName': 'Wei-Ti', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, University of California Los Angeles, 700 Tiverton Ave, Los Angeles, CA, 90095, USA. wchen@sonnnet.ucla.edu.'}, {'ForeName': 'Chengshi', 'Initials': 'C', 'LastName': 'Shiu', 'Affiliation': 'School of Nursing, University of California Los Angeles, 700 Tiverton Ave, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, 201508, China. zhanglin@shphc.org.cn.'}, {'ForeName': 'Hongxin', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China. 13911022130@163.com.'}]",BMC public health,['10.1186/s12889-022-13573-3']
2007,35705927,Counting on U training to enhance trusting relationships and mental health literacy among business advisors: protocol for a randomised controlled trial.,"BACKGROUND


Financial distress is thought to be a key reason why small-medium enterprise (SME) owners experience higher levels of mental health conditions compared with the broader population. Business advisors who form trusting, high-quality relationships with their SME clients, are therefore well placed to: (1) help prevent/reduce key sources of financial distress, (2) better understand the business and personal needs of their clients and, (3) recognise the signs and symptoms of mental health conditions and encourage help-seeking where appropriate. The aim of this study is to compare the effectiveness of relationship building training (RBT) combined with mental health first aid (MHFA) training for business advisors with MHFA alone, on the financial and mental health of their SME-owner clients.
METHODS


This is a single blind, two-arm randomised controlled trial. Participants will be business advisors who provide information, guidance and/or assistance to SME owner clients and are in contact with them at least 3 times a year. The business advisors will invite their SME-owner clients to complete 3 online surveys at baseline, 6- and 12-months. Business advisors will be randomised to one of two conditions, using a 1:1 allocation ratio: (1) MHFA with RBT; or (2) MHFA alone, and complete 3 online surveys at baseline, 2- and 6-months. Primary outcomes will be measured in the business advisors and consist of the quality of the relationship, stigmatizing attitude, confidence to offer mental health first aid, quality of life and provision of mental health first aid. Secondary outcomes will be measured in the SME owners and includes trust in their business advisors, the quality of this relationship, financial wellbeing, financial distress, psychological distress, help-seeking behaviour, and quality of life. To complement the quantitative data, we will include a qualitative process evaluation to examine what contextual factors impacted the reach, effectiveness, adoption, implementation, and maintenance of the training.
DISCUSSION


As there is evidence for the connections between client trust, quality of relationship and financial and mental wellbeing, we hypothesise that the combined RBT and MHFA training will lead to greater improvements in these outcomes in SME owners compared with MHFA alone.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT04982094 . Retrospectively registered 29/07/2021. The study started in February 2021 and the recruitment is ongoing.",2022,"Primary outcomes will be measured in the business advisors and consist of the quality of the relationship, stigmatizing attitude, confidence to offer mental health first aid, quality of life and provision of mental health first aid.","['business advisors with MHFA alone, on the financial and mental health of their SME-owner clients']","['relationship building training (RBT) combined with mental health first aid (MHFA) training', 'U training']","['SME\xa0owners and includes trust in their business advisors, the quality of this relationship, financial wellbeing, financial distress, psychological distress, help-seeking behaviour, and quality of life', 'business advisors and consist of the quality of the relationship, stigmatizing attitude, confidence to offer mental health first aid, quality of life and provision of mental health first aid']","[{'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016143', 'cui_str': 'First aid'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016143', 'cui_str': 'First aid'}]",,0.197536,"Primary outcomes will be measured in the business advisors and consist of the quality of the relationship, stigmatizing attitude, confidence to offer mental health first aid, quality of life and provision of mental health first aid.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Saxon', 'Affiliation': 'Deakin Business School, Deakin University, Burwood, VIC, Australia. l.saxon@deakin.edu.au.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bromfield', 'Affiliation': 'Deakin Business School, Deakin University, Burwood, VIC, Australia.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Leow-Taylor', 'Affiliation': 'Deakin Business School, Deakin University, Burwood, VIC, Australia.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Vega', 'Affiliation': 'Deakin Business School, Deakin University, Burwood, VIC, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation (IMPACT), Food and Mood Centre, School of Medicine, Barwon Health, Deakin University, Burwood, VIC, Australia.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'LaMontagne', 'Affiliation': 'Institute for Health Transformation, Deakin University, Burwood, VIC, Australia.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Martin', 'Affiliation': 'Tasmanian School of Business and Economics, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Burwood, VIC, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nielsen', 'Affiliation': 'Sheffield University Management School, Sheffield, UK.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Reavley', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Conway', 'Affiliation': 'Institute of Public Accountants, Melbourne, VIC, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Silva', 'Affiliation': 'Research Division, WorkSafe Victoria, Geelong, VIC, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Memish', 'Affiliation': 'Beyond Blue, Melbourne, VIC, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rossetto', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tanewski', 'Affiliation': 'Deakin Business School, Deakin University, Burwood, VIC, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Noblet', 'Affiliation': 'Deakin Business School, Deakin University, Burwood, VIC, Australia.'}]",BMC psychiatry,['10.1186/s12888-022-04034-7']
2008,35706340,Remimazolam Tosilate Sedation with Adjuvant Sufentanil in Chinese Patients with Liver Cirrhosis Undergoing Gastroscopy: A Randomized Controlled Study.,"BACKGROUND This prospective, randomized, controlled study evaluated the efficacy and safety of remimazolam tosilate sedation with adjuvant sufentanil, relative to propofol, for Chinese patients with liver cirrhosis undergoing gastroscopy. MATERIAL AND METHODS Patients with liver cirrhosis (n=148) aged 18-65 years and undergoing gastroscopy were randomly and equally allocated to receive either 0.107 mg/kg remimazolam tosilate (remimazolam group) or 2 mg/kg propofol. Patients received intravenous sufentanil 0.15 μg/kg before the study drug. If necessary, an additional dose of propofol 20 mg was used and repeated. The primary outcome was the satisfaction rating (satisfactory, fair, or unsatisfactory) of the endoscopist with the sedation. Secondary outcomes were complications (respiratory depression, apnea, body movement, bradycardia, hypotension, nausea or vomiting, somnolence, dizziness, and fever) and patient satisfaction. RESULTS Compared with the propofol group, the remimazolam group required a longer time to sedation and a shorter time to emergence. The percentage of remimazolam sedations the endoscopist rated satisfactory (90.5%) was higher than that for propofol (77.0%; P=0.026). Patients given remimazolam experienced lower rates of respiratory depression, body movement, and hypotension (2.7, 8.1, 4.1%, respectively), than did the propofol group (17.6, 23.0, 14.9%; P=0.003, 0.013, 0.025). The 2 groups were comparable regarding the other secondary outcomes. CONCLUSIONS For Chinese patients with liver cirrhosis undergoing gastroscopy, remimazolam tosilate with adjuvant sufentanil provides a satisfactory level of sedation with a good safety profile.",2022,"Patients given remimazolam experienced lower rates of respiratory depression, body movement, and hypotension (2.7, 8.1, 4.1%, respectively), than did the propofol group (17.6, 23.0, 14.9%; P=0.003, 0.013, 0.025).","['Chinese patients with liver cirrhosis undergoing gastroscopy', 'Patients with liver cirrhosis ', 'Chinese patients with liver cirrhosis undergoing gastroscopy, remimazolam tosilate with adjuvant', 'n=148) aged 18-65 years and undergoing gastroscopy', 'Chinese Patients with Liver Cirrhosis Undergoing Gastroscopy']","['propofol', 'remimazolam tosilate sedation with adjuvant sufentanil', 'Remimazolam Tosilate Sedation with Adjuvant Sufentanil', 'remimazolam', 'intravenous sufentanil', 'remimazolam tosilate (remimazolam group) or 2 mg/kg propofol', 'sufentanil']","['complications (respiratory depression, apnea, body movement, bradycardia, hypotension, nausea or vomiting, somnolence, dizziness, and fever) and patient satisfaction', 'satisfaction rating (satisfactory, fair, or unsatisfactory) of the endoscopist with the sedation', 'rates of respiratory depression, body movement, and hypotension', 'longer time to sedation']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",148.0,0.0458221,"Patients given remimazolam experienced lower rates of respiratory depression, body movement, and hypotension (2.7, 8.1, 4.1%, respectively), than did the propofol group (17.6, 23.0, 14.9%; P=0.003, 0.013, 0.025).","[{'ForeName': 'YingHao', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China (mainland).'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Anesthesiology, Beijing YouAn Hospital, Capital Medical University, Beijing, China (mainland).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Zoology and Physiology, University of Wyoming, Laramie, WY, USA.'}, {'ForeName': 'WenFei', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, Beijing YouAn Hospital, Capital Medical University, Beijing, China (mainland).'}, {'ForeName': 'ZheFen', 'Initials': 'Z', 'LastName': 'Quan', 'Affiliation': 'Department of Anesthesiology, Beijing YouAn Hospital, Capital Medical University, Beijing, China (mainland).'}, {'ForeName': 'Fu Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.936580']
2009,35706636,Comparison of effect of etomidate with propofol on hemodynamics during modified electroconvulsive therapy.,"Background and Aims


Studies comparing the effect of propofol and etomidate on hemodynamic parameters during electroconvulsive therapy (ECT) have shown ambiguous results. Although some studies observed a larger increase in blood pressure and heart rate during the use of etomidate than propofol in ECT, whereas some studies have shown no difference in hemodynamic parameters with the use of etomidate or propofol. Most of the studies done to compare the hemodynamic effects of etomidate and propofol were limited by small sample size or retrospective in nature. Therefore, we conducted a prospective randomized trial to compare the effects of etomidate and propofol on hemodynamics during ECT.
Material and Methods


A prospective randomized crossover study was conducted on 30 patients with American Society of Anesthesiologist physical status I and II, between age 18 and 65 years, suffering from a mental disorder as per International Classification of Diseases-10 and requiring bilateral ECT as per clinical decision of consultant psychiatrist. They were randomized to receive both the drugs for their successive ECT sessions and were subjected to evaluation after clubbing together the ECT sessions of propofol or etomidate as anesthetic agent.
Results


Duration of motor seizures was significantly more in patients receiving etomidate, whereas patients receiving propofol had more stable hemodynamics.
Conclusion


Though propofol maintains stable hemodynamics during MECT, yet clinical applicability of etomidate outstrips it by a reasonable margin due to its better effect on seizure parameters.",2022,"Duration of motor seizures was significantly more in patients receiving etomidate, whereas patients receiving propofol had more stable hemodynamics.
","['30 patients with American Society of Anesthesiologist physical status I and II, between age 18 and 65 years, suffering from a mental disorder as per International Classification of Diseases-10 and requiring bilateral ECT as per clinical decision of consultant psychiatrist']","['etomidate with propofol', 'propofol', 'propofol or etomidate', 'etomidate', 'propofol and etomidate', 'electroconvulsive therapy (ECT', 'etomidate and propofol']","['hemodynamic effects', 'stable hemodynamics', 'blood pressure and heart rate', 'hemodynamic parameters', 'Duration of motor seizures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0562343', 'cui_str': 'Bilateral electroconvulsive therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}]","[{'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0751494', 'cui_str': 'Seizures, Convulsive'}]",30.0,0.0128307,"Duration of motor seizures was significantly more in patients receiving etomidate, whereas patients receiving propofol had more stable hemodynamics.
","[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'Department of Anaesthesia, Artemis Health Institute, Gurugram, Haryana, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Palta', 'Affiliation': 'Department of Anesthesia and Critical Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Psychiatry, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Saroa', 'Affiliation': 'Department of Anesthesia and Critical Care, Government Medical College and Hospital, Chandigarh, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_185_20']
2010,35706624,Comparison of intrathecal bupivacaine-fentanyl and bupivacaine-butorphanol combinations for joint replacement surgeries.,"Background and Aims


The objective of the study was to compare duration of analgesia of fentanyl versus butorphanol as adjuvants to bupivacaine in spinal anesthesia.
Material and Methods


A prospective, randomized, double-blinded study conducted in 80 patients of 18-75 years age group and American Society of Anesthesiologists Grades I and II undergoing joint replacement surgeries. A total of 40 patients in each Group A and Group B received 0.5% bupivacaine 3 ml with 25 mcg fentanyl and 25 mcg butorphanol respectively, in a total volume of 3.5 ml made with saline. Duration of analgesia, number of rescue analgesia, sensory, and motor block characteristics were compared between the two groups. Statistical analysis was done using  t  test and Chi-square test with SPSS 19.0 software.
Results


Mean duration of analgesia was found more in Group B in comparison to Group A ( P  < 0.05). A number of doses of analgesic required postoperatively were more in Group A compared to Group B ( P  < 0.001). Time required for onset of sensory and motor block was comparable in both the groups. However, two segment regression of sensory block was slower in Group B compared to Group A ( P  < 0.05).
Conclusion


We conclude that addition of butorphanol 25 μg as an adjuvant to 0.5% hyperbaric bupivacaine provided prolonged duration of analgesia compared to 25 mg fentanyl.",2022,"However, two segment regression of sensory block was slower in Group B compared to Group A ( P  < 0.05).
","['joint replacement surgeries', '80 patients of 18-75 years age group and American Society of Anesthesiologists Grades']","['intrathecal bupivacaine-fentanyl and bupivacaine-butorphanol', 'butorphanol', 'hyperbaric bupivacaine', 'saline', 'bupivacaine 3 ml with 25 mcg fentanyl', 'fentanyl versus butorphanol', 'bupivacaine']","['Time required for onset of sensory and motor block', 'sensory block', 'Mean duration of analgesia', 'prolonged duration of analgesia', 'Duration of analgesia, number of rescue analgesia, sensory, and motor block characteristics']","[{'cui': 'C0185317', 'cui_str': 'Implantation of joint prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439211', 'cui_str': 'mcg'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",80.0,0.164255,"However, two segment regression of sensory block was slower in Group B compared to Group A ( P  < 0.05).
","[{'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesia, PGI Chandigarh, Punjab, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kumari', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Punjab, India.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Punjab, India.'}, {'ForeName': 'Shubhdeep', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Punjab, India.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Arora', 'Affiliation': 'Department of Anaesthesia, PGI Chandigarh, Punjab, India.'}, {'ForeName': 'Keerat', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Department of Anaesthesia, PGI Chandigarh, Punjab, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_94_20']
2011,35706620,"Comparative evaluation of Intubating Laryngeal Mask Airway (ILMA), I-gel and Ambu AuraGain for blind tracheal intubation in adults.","Background and Aims


The supraglottic airway devices (SADs) that allow direct (without an intermediary device like Aintree or airway exchange catheters) tracheal intubation can be invaluable for field use in conditions ideally managed by intubation. Whilst fiberscope-guided intubation is the method of choice, if these 'direct-intubation' SADs could provide high success rates for blind tracheal intubation, their scope of use can increase tremendously. Our study assesses intubating laryngeal mask airway (ILMA), i-gel and Ambu AuraGain for blind tracheal intubation in adults.
Material and Methods


Ninety adults undergoing elective surgery were randomized into three equal groups. After induction of anesthesia, the group-specific SAD was inserted and on achieving adequate ventilation, blind tracheal intubation was attempted over two attempts. Success rates and time of achieving adequate device placement and tracheal intubation through these were evaluated. Data were analyzed using SPSS version 17.0 and  P  < 0.05 was considered statistically significant.
Results


All three devices could achieve adequate ventilation within two allowed attempts. Successful tracheal intubation rates were significantly better with ILMA than i-gel on first attempt (87% vs. 27%,  P  < 0.001) and after second attempt that was supplemented with optimization maneuvers (100% vs. 40%,  P  < 0.001). No patient could be intubated through Ambu AuraGain within two attempts. Time taken for successful tracheal intubation did not differ significantly ( P  = 0.205) with ILMA or i-gel.
Conclusion


Out of ILMA, I-gel and Ambu AuraGain, ILMA is the best device for blind tracheal intubation in adults with normal airways.",2022,"Successful tracheal intubation rates were significantly better with ILMA than i-gel on first attempt (87% vs. 27%,  P  < 0.001) and after second attempt that was supplemented with optimization maneuvers (100% vs. 40%,  P  < 0.001).","['Ninety adults undergoing elective surgery', 'adults with normal airways', 'blind tracheal intubation in adults']","['tracheal intubation', 'exchange catheters', 'intubating laryngeal mask airway (ILMA), i-gel and Ambu AuraGain', 'ILMA', 'Intubating Laryngeal Mask Airway (ILMA), I-gel and Ambu AuraGain']","['Success rates and time of achieving adequate device placement and tracheal intubation', 'Successful tracheal intubation rates', 'Time taken for successful tracheal intubation']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",90.0,0.0276523,"Successful tracheal intubation rates were significantly better with ILMA than i-gel on first attempt (87% vs. 27%,  P  < 0.001) and after second attempt that was supplemented with optimization maneuvers (100% vs. 40%,  P  < 0.001).","[{'ForeName': 'Riniki', 'Initials': 'R', 'LastName': 'Sarma', 'Affiliation': 'Department of Oncoanaesthesia and Palliative Medicine, Dr. BRAIRCH, Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Maulana Azad Medical College, Delhi, India.'}, {'ForeName': 'Neera Gupta', 'Initials': 'NG', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Maulana Azad Medical College, Delhi, India.'}, {'ForeName': 'Munisha', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Maulana Azad Medical College, Delhi, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Rajiv Gandhi Cancer Institute, Delhi, India.'}, {'ForeName': 'Saud Ahmed', 'Initials': 'SA', 'LastName': 'Ansari', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Maulana Azad Medical College, Delhi, India.'}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Deepak', 'Affiliation': 'Department of Neuroanaesthesia and Critical Care, AIIMS, Delhi, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_239_20']
2012,35706617,Role of endotracheal tube size on nasal and laryngeal morbidity during awake fiberoptic nasotracheal intubation: A Randomized controlled trial.,"Background and Aims


Awake fibreoptic nasotracheal intubation is associated with adverse airway and hemodynamic complications. The aim of this study was to evaluate the role of endotracheal tube size on nasal and laryngeal morbidity during awake fibreoptic-guided nasotracheal intubation.
Material and Methods


Eighty patients recruited to undergo awake fibreoptic intubation were randomly allocated to Group C (standard size endotracheal tube) and Group S (small size endotracheal tube followed by exchange to standard size using Airway Exchange Catheter under general anesthesia). Nasal morbidity was assessed by incidence of epistaxis, olfactory acuity, and mucociliary clearance. Patient discomfort during intubation was assessed using grimace score and hemodynamic parameters were recorded. Postoperatively, the incidence of nasal and laryngeal injury was recorded using nasendoscopy and telelaryngoscopy, respectively.
Results


Demographic profile between the two groups was comparable. Epistaxis was noted in 47.5% of patients in group C as compared to 12.5% in group S. Postoperative olfactory acuity was decreased [2 (1-4) vs 4 (2-5)] and saccharin clearance time was prolonged (314 s vs 134 s) in Group C as compared to Group S. ( P -value <0.001) Higher grimace score [2 (1-3) vs 1 (0-2)] and increased hemodynamic response was demonstrated in Group C. ( P -value <0.001) Incidence of nasal injury [2 (1-4) vs 1 (0-2)] and laryngeal injury [1 (0-2) vs 0 (0-2)] was more in Group C as compared to Group S.
Conclusion


Awake fibreoptic nasotracheal intubation with small size endotracheal tube followed by exchange to standard size under general anesthesia reduces nasal, laryngeal, and hemodynamic complications.",2022,"Higher grimace score [2 (1-3) vs 1 (0-2)] and increased hemodynamic response was demonstrated in Group C. ( P -value <0.001) Incidence of nasal injury [2 (1-4) vs 1 (0-2)] and laryngeal injury [1 (0-2) vs 0 (0-2)] was more in Group C as compared to Group S.
Conclusion


Awake fibreoptic nasotracheal intubation with small size endotracheal tube followed by exchange to standard size under general anesthesia reduces nasal, laryngeal, and hemodynamic complications.","['Eighty patients recruited to undergo awake fibreoptic intubation', 'awake fiberoptic nasotracheal intubation']","['Group C (standard size endotracheal tube) and Group S (small size endotracheal tube followed by exchange to standard size using Airway Exchange Catheter under general anesthesia', 'awake fibreoptic-guided nasotracheal intubation', 'endotracheal tube size']","['nasal and laryngeal morbidity', 'saccharin clearance time', 'Nasal morbidity', 'Epistaxis', 'Postoperative olfactory acuity', 'incidence of epistaxis, olfactory acuity, and mucociliary clearance', 'hemodynamic response', 'incidence of nasal and laryngeal injury']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0472581', 'cui_str': 'Nasotracheal fiberoptic intubation'}]","[{'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3164441', 'cui_str': 'Airway exchange catheter'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036023', 'cui_str': 'Saccharin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0339881', 'cui_str': 'Injury of larynx'}]",80.0,0.0780322,"Higher grimace score [2 (1-3) vs 1 (0-2)] and increased hemodynamic response was demonstrated in Group C. ( P -value <0.001) Incidence of nasal injury [2 (1-4) vs 1 (0-2)] and laryngeal injury [1 (0-2) vs 0 (0-2)] was more in Group C as compared to Group S.
Conclusion


Awake fibreoptic nasotracheal intubation with small size endotracheal tube followed by exchange to standard size under general anesthesia reduces nasal, laryngeal, and hemodynamic complications.","[{'ForeName': 'Stalin', 'Initials': 'S', 'LastName': 'Vinayagam', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Thirumurugan', 'Initials': 'T', 'LastName': 'Arikrishnan', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kundra', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Sunil Kumar', 'Initials': 'SK', 'LastName': 'Saxena', 'Affiliation': 'Department of Ear, Nose and Throat, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_209_20']
2013,35706495,"Effect of moderate to high intensity aerobic exercise on blood pressure in young adults: The TEPHRA open, two-arm, parallel superiority randomized clinical trial.","Background


Exercise is advised for young adults with elevated blood pressure, but no trials have investigated efficacy at this age. We aimed to determine whether aerobic exercise, self-monitoring and motivational coaching lowers blood pressure in this group.
Methods


The study was a single-centre, open, two-arm, parallel superiority randomized clinical trial with open community-based recruitment of physically-inactive 18-35 year old adults with awake 24 h blood pressure 115/75mmHg-159/99 mmHg and BMI<35 kg/m 2 . The study took place in the Cardiovascular Clinical Research Facility, John Radcliffe Hospital, Oxford, UK. Participants were randomized (1:1) with minimisation factors sex, age (<24, 24-29, 30-35 years) and gestational age at birth (<32, 32-37, >37 weeks) to the intervention group, who received 16-weeks aerobic exercise training (three aerobic training sessions per week of 60 min per session at 60-80% peak heart rate, physical activity self-monitoring with encouragement to do 10,000 steps per day and motivational coaching to maintain physical activity upon completion of the intervention. The control group were sign-posted to educational materials on hypertension and recommended lifestyle behaviours. Investigators performing statistical analyses were blinded to group allocation. The primary outcome was 24 h awake ambulatory blood pressure (systolic and diastolic) change from baseline to 16-weeks on an intention-to-treat basis. Clinicaltrials.gov registered on March 30, 2016 (NCT02723552).
Findings


Enrolment occurred between 30/06/2016-26/10/2018. Amongst the 203 randomized young adults ( n  = 102 in the intervention group;  n  = 101 in the control group), 178 (88%;  n  = 76 intervention group,  n  = 84 control group) completed 16-week follow-up and 160 (79%;  n  = 68 intervention group,  n  = 69 control group) completed 52-weeks follow-up. There were no group differences in awake systolic (0·0 mmHg [95%CI, -2·9 to 2·8];  P  = 0·98) or awake diastolic ambulatory blood pressure (0·6 mmHg [95%CI, -1·4. to 2·6];  P  = 0·58). Aerobic training increased peak oxygen uptake (2·8 ml/kg/min [95%CI, 1·6 to 4·0]) and peak wattage (14·2watts [95%CI, 7·6 to 20·9]) at 16-weeks. There were no intervention effects at 52-weeks follow-up.
Intepretation


These results do not support the exclusive use of moderate to high intensity aerobic exercise training for blood pressure control in young adults.
Funding


Wellcome Trust, British Heart Foundation, National Institute for Health Research, Oxford Biomedical Research Centre.",2022,"Aerobic training increased peak oxygen uptake (2·8 ml/kg/min [95%CI, 1·6 to 4·0]) and peak wattage (14·2watts [95%CI, 7·6 to 20·9]) at 16-weeks.","['young adults', 'open community-based recruitment of physically-inactive 18-35 year old adults with awake 24\xa0h blood pressure 115/75mmHg-159/99\xa0mmHg and BMI<35\xa0kg/m 2 ', 'to 2·6', 'Participants were randomized (1:1) with minimisation factors sex, age (<24, 24-29, 30-35 years) and gestational age at birth (<32, 32-37, >37 weeks) to the intervention group', 'young adults with elevated blood pressure', '203 randomized young adults ( n \xa0=\xa0102 in the intervention group;  n \xa0=\xa0101 in the control group), 178 (88']","['intensity aerobic exercise training', '16-weeks aerobic exercise training (three aerobic training sessions per week of 60\xa0min per session at 60-80% peak heart rate, physical activity self-monitoring with encouragement to do 10,000 steps per day and motivational coaching', 'moderate to high intensity aerobic exercise', 'Aerobic training', '\n\n\nExercise', 'n \xa0=\xa084 control group) completed 16-week follow-up and 160 (79%;  n \xa0=\xa068 intervention group,  n \xa0=\xa069 control group) completed 52-weeks follow-up', 'aerobic exercise, self-monitoring and motivational coaching']","['24\xa0h awake ambulatory blood pressure (systolic and diastolic) change from baseline to 16-weeks on an intention-to-treat basis', 'blood pressure control', 'awake diastolic ambulatory blood pressure (0·6', 'awake systolic', 'blood pressure', 'peak oxygen uptake']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",,0.15814,"Aerobic training increased peak oxygen uptake (2·8 ml/kg/min [95%CI, 1·6 to 4·0]) and peak wattage (14·2watts [95%CI, 7·6 to 20·9]) at 16-weeks.","[{'ForeName': 'Wilby', 'Initials': 'W', 'LastName': 'Williamson', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Adam James', 'Initials': 'AJ', 'LastName': 'Lewandowski', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Odaro John', 'Initials': 'OJ', 'LastName': 'Huckstep', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Winok', 'Initials': 'W', 'LastName': 'Lapidaire', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Ooms', 'Affiliation': 'Nuffield Department of Orthopaedics, Centre for Statistics in Medicine, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Afifah', 'Initials': 'A', 'LastName': 'Mohamed', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Alsharqi', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Bertagnolli', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Woodward', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Dockerill', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'McCourt', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Kenworthy', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Burchert', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}, {'ForeName': 'Aiden', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Nuffield Department of Population Health, BHF Centre of Research Excellence, University of Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Newton', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Switzerland.'}, {'ForeName': 'John Kennedy', 'Initials': 'JK', 'LastName': 'Cruickshank', 'Affiliation': 'School of Lifecourse Sciences, Kings College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Holmes', 'Affiliation': 'Nuffield Department of Orthopaedics, Centre for Statistics in Medicine, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Warwick, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Frangou', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Everett', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Hillsdon', 'Affiliation': 'Sport and Health Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Foster', 'Affiliation': 'School of Policy Studies, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leeson', 'Affiliation': 'Radcliffe Department of Medicine, Oxford Cardiovascular Clinical Research Facility Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.'}]",EClinicalMedicine,['10.1016/j.eclinm.2022.101445']
2014,35706490,"Effect of acute iron infusion on insulin secretion: A randomized, double-blind, placebo-controlled trial.","Background


Chronic exposure to high iron levels increases diabetes risk partly by inducing oxidative stress, but the consequences of acute iron administration on beta cells are unknown. We tested whether the acute administration of iron for the correction of iron deficiency influenced insulin secretion and the production of reactive oxygen species.
Methods


Single-center, double-blinded, randomized controlled trial conducted between June 2017 and March 2020. 32 women aged 18 to 47 years, displaying symptomatic iron deficiency without anaemia, were recruited from a community setting and randomly allocated (1:1) to a single infusion of 1000 mg intravenous ferric carboxymaltose (iron) or saline (placebo). The primary outcome was the between group mean difference from baseline to day 28 in first and second phase insulin secretion, assessed by a two-step hyperglycaemic clamp. All analyses were performed by intention to treat. This trial was registered in ClinicalTrials.gov NCT03191201.
Findings


Iron infusion did not affect first and second phase insulin release. For first phase, the between group mean difference from baseline to day 28 was 0 μU × 10 min/mL [95% CI, -22 to 22,  P  = 0.99]. For second phase, it was -5 μUx10min/mL [95% CI, -161 to 151;  P  = 0.95] at the first plateau of the clamp and -249 μUx10min/mL [95% CI, -635 to 137;  P  = 0.20] at the second plateau. Iron infusion increased serum ascorbyl/ascorbate ratio, a marker of plasma oxidative stress, at day 14, with restoration of normal ratio at day 28 relative to placebo. Finally, high-sensitive C-reactive protein levels remained similar among groups.
Interpretation


In iron deficient women without anaemia, intravenous administration of 1000 mg of iron in a single sitting did not impair glucose-induced insulin secretion despite a transient increase in the levels of circulating reactive oxygen species.
Funding


The Swiss National Science Foundation, University of Lausanne and Leenaards, Raymond-Berger and Placide Nicod Foundations.",2022,"Iron infusion increased serum ascorbyl/ascorbate ratio, a marker of plasma oxidative stress, at day 14, with restoration of normal ratio at day 28 relative to placebo.","['32 women aged 18 to 47 years, displaying symptomatic iron deficiency without anaemia']","['acute iron infusion', 'μUx10min/mL', 'μU', 'intravenous ferric carboxymaltose (iron) or saline (placebo', 'placebo']","['serum ascorbyl/ascorbate ratio, a marker of plasma oxidative stress', 'baseline to day 28 in first and second phase insulin secretion', 'levels of circulating reactive oxygen species', 'insulin secretion', 'high-sensitive C-reactive protein levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0340950', 'cui_str': 'Iron deficiency without anemia'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",32.0,0.838459,"Iron infusion increased serum ascorbyl/ascorbate ratio, a marker of plasma oxidative stress, at day 14, with restoration of normal ratio at day 28 relative to placebo.","[{'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Jaccard', 'Affiliation': 'Department of Medicine, Lausanne University Hospital (CHUV) and University of Lausanne, rue du Bugnon 46, Lausanne 1011, Switzerland.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Seyssel', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Biology and Medicine, University of Lausanne, rue du Bugnon 7a, Lausanne 1005, Switzerland.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gouveia', 'Affiliation': 'Center for Primary Care and Public Health, University of Lausanne, rue du Bugnon 44, Lausanne, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Vergely', 'Affiliation': ""Pathophysiology and Epidemiology of Cerebro-Cardiovascular Diseases (PEC2, EA7460),UFR des Sciences de Santé, University of Bourgogne Franche-Comté, 7 boulevard Jeanne d' Arc, Dijon 21079, France.""}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Baratali', 'Affiliation': 'Department of Medicine, Lausanne University Hospital (CHUV) and University of Lausanne, rue du Bugnon 46, Lausanne 1011, Switzerland.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Gubelmann', 'Affiliation': 'Department of Medicine, Lausanne University Hospital (CHUV) and University of Lausanne, rue du Bugnon 46, Lausanne 1011, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Froissart', 'Affiliation': 'Clinical Research Center, CHUV, University of Lausanne, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Favrat', 'Affiliation': 'Center for Primary Care and Public Health, University of Lausanne, rue du Bugnon 44, Lausanne, Switzerland.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Marques-Vidal', 'Affiliation': 'Department of Medicine, Lausanne University Hospital (CHUV) and University of Lausanne, rue du Bugnon 46, Lausanne 1011, Switzerland.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Tappy', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Biology and Medicine, University of Lausanne, rue du Bugnon 7a, Lausanne 1005, Switzerland.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Waeber', 'Affiliation': 'Department of Medicine, Lausanne University Hospital (CHUV) and University of Lausanne, rue du Bugnon 46, Lausanne 1011, Switzerland.'}]",EClinicalMedicine,['10.1016/j.eclinm.2022.101434']
2015,35706488,"Active symptom control with or without oral vinorelbine in patients with relapsed malignant pleural mesothelioma (VIM): A randomised, phase 2 trial.","Background


Currently, there is no US Food and Drug Administration approved therapy for patients with pleural mesothelioma who have relapsed following platinum-doublet based chemotherapy. Vinorelbine has demonstrated useful clinical activity in mesothelioma, however its efficacy has not been formally evaluated in a randomised setting. BRCA1 expression is required for vinorelbine induced apoptosis in preclinical models. Loss of expression may therefore correlate with vinorelbine resistance.
Methods


In this randomised, phase 2 trial, patients were eligible if they met the following criteria: age ≥ 18 years, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, histologically confirmed pleural mesothelioma, post platinum-based chemotherapy, and radiological evidence of disease progression. Consented patients were randomised 2:1 to either active symptom control with oral vinorelbine versus active symptom control (ASC) every 3 weeks until disease progression, unacceptable toxicity or withdrawal at an initial dose of 60 mg/m 2  increasing to 80 mg/m 2  post-cycle 1. Randomisation was stratified by histological subtype, white cell count, gender, ECOG performance status and best response during first-line therapy. The study was open label. The primary endpoint was progression-free survival (PFS), measured from randomisation to time of event (or censoring). Analyses were carried out according to intention-to-treat (ITT) principles. Recruitment and trial follow-up are complete. This trial is registered with ClinicalTrials.gov, number NCT02139904.
Findings


Between June 1, 2016 and Oct 31, 2018, we performed a randomised phase 2 trial in 14 hospitals in the United Kingdom. 225 patients were screened for eligibility, of whom 154 were randomly assigned to receive either ASC + vinorelbine ( n  = 98) or ASC ( n  = 56). PFS was significantly longer for ASC+vinorelbine compared with ASC alone; 4.2 months (interquartile range (IQR) 2.2-8.0) versus 2.8 months (IQR 1.4-4.1) for ASC, giving an unadjusted hazard ratio (HR) of 0·60 (80% CI upper limit 0.7, one-sided unadjusted log rank test  p  = 0.002); adjusted HR 0.6 (80% CI upper limit 0.7, one-sided adjusted log rank test  p  < 0.001). BRCA1 did not predict resistance to ASC+vinorelbine. Neutropenia was the most common grades 3, 4 adverse events in the ASC +vinorelbine arm.
Interpretation


Vinorelbine plus ASC confers clinical benefit to patients with relapsed pleural mesothelioma who have progressed following platinum-based doublet chemotherapy.
Funding


This study was funded by Cancer Research UK (grant CRUK A15569).",2022,"PFS was significantly longer for ASC+vinorelbine compared with ASC alone; 4.2 months (interquartile range (IQR) 2.2-8.0) versus 2.8 months (IQR 1.4-4.1) for ASC, giving an unadjusted hazard ratio (HR) of 0·60 (80% CI upper limit 0.7, one-sided unadjusted log rank test  ","['patients with pleural mesothelioma who have relapsed following platinum-doublet based chemotherapy', 'patients with relapsed malignant pleural mesothelioma (VIM', '14 hospitals in the United Kingdom', 'patients with relapsed pleural mesothelioma who have progressed following platinum-based doublet chemotherapy', 'patients were eligible if they met the following criteria: age ≥ 18 years, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, histologically confirmed pleural mesothelioma, post platinum-based chemotherapy, and radiological evidence of disease progression', 'Findings\n\n\nBetween June 1, 2016 and Oct 31, 2018', '225 patients were screened for eligibility, of whom 154']","['ASC +vinorelbine', 'Vinorelbine', 'active symptom control with oral vinorelbine versus active symptom control (ASC) every 3 weeks until disease progression, unacceptable toxicity or withdrawal at an initial dose of 60\xa0mg/m 2  increasing to 80\xa0mg/m 2  post-cycle 1', 'ASC+vinorelbine', 'Active symptom control with or without oral vinorelbine', 'vinorelbine', 'BRCA1', 'ASC\xa0+\xa0vinorelbine', 'ASC', 'Vinorelbine plus ASC']","['Neutropenia', 'progression-free survival (PFS), measured from randomisation to time of event (or censoring', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0854891', 'cui_str': 'Pleural mesothelioma malignant recurrent'}, {'cui': 'C0042666', 'cui_str': 'Vimentin'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C5191279', 'cui_str': '154'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C4759356', 'cui_str': 'Time of event'}]",225.0,0.347733,"PFS was significantly longer for ASC+vinorelbine compared with ASC alone; 4.2 months (interquartile range (IQR) 2.2-8.0) versus 2.8 months (IQR 1.4-4.1) for ASC, giving an unadjusted hazard ratio (HR) of 0·60 (80% CI upper limit 0.7, one-sided unadjusted log rank test  ","[{'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'Mesothelioma Research Programme, University of Leicester, Robert Kilpatrick Clinical Sciences Building, Leicester LE2 7LX, UK.'}, {'ForeName': 'Catharine', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': 'Centre for Trials Research, Cardiff University, Wales, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lester', 'Affiliation': 'The Rutherford Cancer Centre, Newport, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Danson', 'Affiliation': 'Sheffield ECMC, University of Sheffield and Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'Department of Medical Oncology, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sheaff', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Rudd', 'Affiliation': 'The London Clinic, London, UK.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Gaba', 'Affiliation': 'Mesothelioma Research Programme, University of Leicester, Robert Kilpatrick Clinical Sciences Building, Leicester LE2 7LX, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Busacca', 'Affiliation': 'Mesothelioma Research Programme, University of Leicester, Robert Kilpatrick Clinical Sciences Building, Leicester LE2 7LX, UK.'}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'Nixon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Wales, UK.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Gardner', 'Affiliation': 'Centre for Trials Research, Cardiff University, Wales, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Darlison', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Poile', 'Affiliation': 'Mesothelioma Research Programme, University of Leicester, Robert Kilpatrick Clinical Sciences Building, Leicester LE2 7LX, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Richards', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Peter-Wells', 'Initials': 'PW', 'LastName': 'Jordan', 'Affiliation': 'Mesothelioma Research Programme, University of Leicester, Robert Kilpatrick Clinical Sciences Building, Leicester LE2 7LX, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'CRUK Southampton Clinical Trials Unit, University of, Southampton, Southampton, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Casbard', 'Affiliation': 'Centre for Trials Research, Cardiff University, Wales, UK.'}]",EClinicalMedicine,['10.1016/j.eclinm.2022.101432']
2016,35706482,"The NEVERMIND e-health system in the treatment of depressive symptoms among patients with severe somatic conditions: A multicentre, pragmatic randomised controlled trial.","Background


This study assessed the effectiveness of the NEVERMIND e-health system, consisting of a smart shirt and a mobile application with lifestyle behavioural advice, mindfulness-based therapy, and cognitive behavioural therapy, in reducing depressive symptoms among patients diagnosed with severe somatic conditions. Our hypothesis was that the system would significantly decrease the level of depressive symptoms in the intervention group compared to the control group.
Methods


This pragmatic, randomised controlled trial included 425 patients diagnosed with myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants were recruited from hospitals in Turin and Pisa (Italy), and Lisbon (Portugal), and were randomly assigned to either the NEVERMIND intervention or to the control group. Clinical interviews and structured questionnaires were administered at baseline, 12 weeks, and 24 weeks. The primary outcome was depressive symptoms at 12 weeks measured by the Beck Depression Inventory II (BDI-II). Intention-to-treat analyses included 425 participants, while the per-protocol analyses included 333 participants. This trial is registered in the German Clinical Trials Register, DRKS00013391.
Findings


Patients were recruited between Dec 4, 2017, and Dec 31, 2019, with 213 assigned to the intervention and 212 to the control group. The sample had a mean age of 59·41 years (SD=10·70), with 44·24% women. Those who used the NEVERMIND system had statistically significant lower depressive symptoms at the 12-week follow-up (mean difference=-3·03,  p <0·001; 95% CI -4·45 to -1·62) compared with controls, with a clinically relevant effect size (Cohen's  d =0·39).
Interpretation


The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions.
Funding


The NEVERMIND project received funding from the European Union's Horizon 2020 Research and Innovation Programme under grant agreement No. 689691.",2022,"The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions.
","['patients with severe somatic conditions', 'patients with the studied somatic conditions', 'Participants were recruited from hospitals in Turin and Pisa (Italy), and Lisbon (Portugal', 'The sample had a mean age of 59·41 years (SD=10·70), with 44·24% women', 'Findings\n\n\nPatients were recruited between Dec 4, 2017, and Dec 31, 2019, with 213 assigned to the intervention and 212 to the control group', '425 patients diagnosed with myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation', 'patients diagnosed with severe somatic conditions', '425 participants, while the per-protocol analyses included 333 participants']","['smart shirt and a mobile application with lifestyle behavioural advice, mindfulness-based therapy, and cognitive behavioural therapy']","['level of depressive symptoms', 'depressive symptoms', 'Beck Depression Inventory II (BDI-II']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517724', 'cui_str': '333'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0453917', 'cui_str': 'Shirt'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",425.0,0.47804,"The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions.
","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Carli', 'Affiliation': 'National Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Nuhamin Gebrewold', 'Initials': 'NG', 'LastName': 'Petros', 'Affiliation': 'National Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gergö', 'Initials': 'G', 'LastName': 'Hadlaczky', 'Affiliation': 'National Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Vitcheva', 'Affiliation': 'National Centre for Suicide Research and Prevention of Mental Ill-Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, Università degli Studi di Torino, Turin, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bianchi', 'Affiliation': 'Research Center ""E.Piaggio"" and Department of Information Engineering, School of Engineering, Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Carletto', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", Università degli Studi di Torino, Turin, Italy.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Christinaki', 'Affiliation': 'School of Computer Science and Electronic Engineering, University of Essex, Colchester, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Citi', 'Affiliation': 'School of Computer Science and Electronic Engineering, University of Essex, Colchester, UK.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Dinis', 'Affiliation': 'Faculdade de Medicina and CCUL, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gentili', 'Affiliation': 'General Psychology Department, Università degli Studi di Padova, Padua, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Geraldes', 'Affiliation': 'Faculdade de Medicina and CCUL, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Giovinazzo', 'Affiliation': 'Department of Clinical and Biological Sciences, Università degli Studi di Torino, Turin, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Gonzalez-Martinez', 'Affiliation': 'Life Supporting Technologies, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'GAIA AG, Hamburg, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ostacoli', 'Affiliation': 'Department of Clinical and Biological Sciences, Università degli Studi di Torino, Turin, Italy.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ottaviano', 'Affiliation': 'Life Supporting Technologies, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ouakinin', 'Affiliation': 'Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Tasos', 'Initials': 'T', 'LastName': 'Papastylianou', 'Affiliation': 'School of Computer Science and Electronic Engineering, University of Essex, Colchester, UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Paradiso', 'Affiliation': 'Smartex, Pisa, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Poli', 'Affiliation': 'School of Computer Science and Electronic Engineering, University of Essex, Colchester, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Rocha', 'Affiliation': 'Faculdade de Medicina and CCUL, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Settanta', 'Affiliation': 'Department of Clinical and Biological Sciences, Università degli Studi di Torino, Turin, Italy.'}, {'ForeName': 'Enzo Pasquale', 'Initials': 'EP', 'LastName': 'Scilingo', 'Affiliation': 'Research Center ""E.Piaggio"" and Department of Information Engineering, School of Engineering, Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Valenza', 'Affiliation': 'Research Center ""E.Piaggio"" and Department of Information Engineering, School of Engineering, Università di Pisa, Pisa, Italy.'}]",EClinicalMedicine,['10.1016/j.eclinm.2022.101423']
2017,35706479,Single Blind Randomized Controlled Trial of Modified Constraint-Induced Movement Therapy in Infants With the Sequelas of Unilateral Brachial Plexus Injury.,"Objective


To explore the effect of modified constraint-induced movement therapy (mCIMT) on upper limbs residual dysfunction for infancy with the sequelas of unilateral brachial plexus injury (uBPI).
Methods


Single blind randomized controlled trial of mCIMT vs. standard care. An enrolling 31 infants with a uBPI exhibiting residual dysfunction of the affected upper limb for over 6 months was conducted. And functional outcomes pertaining to the affected upper limb were assessed  via  AMS, GRES, RHS, and MSS at 0, 3, and 6 months after treatment.
Results


No differences were found in baseline (acquisition phase) AMS, MSS, GRES, or RHS between the control and mCIMT groups [ F (1, 14) = 0.062,  P  = 0.086;  F (1, 14) = 0.483,  P  = 0.499;  F (1, 14) = 0.272,  P  = 0.610;  Z  = -0.336,  P  = 7.373]. At the 3- and 6-month follow-up time points, AMS, MSS, and GRES scores were significantly improved over baseline in both groups [mCIMT:  F (2, 30) = 183.750, 128.614, 110.085,  P  < 0.05; Control:  F (2, 28) = 204.007, 75.246, 51.070,  P  < 0.05]. No significant differences were found between two treatment groups at the 3-month follow-up time point [ F (1, 14) = 0.565,  P  = 0.465;  F (1, 14) = 0.228,  P  = 0.641;  F (1, 14) = 0.713,  P  = 0.413;  Z  = -0.666,  P  = 0.505]. However, at the 6-month follow-up time point, AMS and MSS scores were significantly improved in the mCIMT group relative to the control group [ F (1, 14) = 8.077,  P  = 0.013;  F (1, 14) = 18.692,  P  = 0.001].
Conclusion


mCIMT may benefit the rehabilitation of residual upper limb dysfunction associated with a uBPI in infants.
Clinical Trial Registration


[www.chictr.org.cn], identifier [ChiCTR1900022119].",2022,"No differences were found in baseline (acquisition phase) AMS, MSS, GRES, or RHS between the control and mCIMT groups [ F (1, 14) = 0.062,  P  = 0.086;  F (1, 14) = 0.483,  P  = 0.499;  F (1, 14) = 0.272,  P  = 0.610;  Z  = -0.336,  P  = 7.373].","['An enrolling 31 infants with a uBPI exhibiting residual dysfunction of the affected upper limb for over 6 months was conducted', 'upper limbs residual dysfunction for infancy with the sequelas of unilateral brachial plexus injury (uBPI', 'Infants With the Sequelas of Unilateral Brachial Plexus Injury']","['Modified Constraint-Induced Movement Therapy', 'modified constraint-induced movement therapy (mCIMT', 'mCIMT', 'mCIMT vs. standard care']","['AMS, MSS, and GRES scores', 'via  AMS, GRES, RHS, and MSS', 'AMS and MSS scores', 'baseline (acquisition phase) AMS, MSS, GRES, or RHS']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0161446', 'cui_str': 'Injury of brachial plexus'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}, {'cui': 'C0024814', 'cui_str': 'Marinesco-Sjögren syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0398739', 'cui_str': 'Leukocyte adhesion deficiency - type 2'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",31.0,0.094993,"No differences were found in baseline (acquisition phase) AMS, MSS, GRES, or RHS between the control and mCIMT groups [ F (1, 14) = 0.062,  P  = 0.086;  F (1, 14) = 0.483,  P  = 0.499;  F (1, 14) = 0.272,  P  = 0.610;  Z  = -0.336,  P  = 7.373].","[{'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Cui', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatric, Anhui Province Maternity and Child Health Hospital, Hefei, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Pediatric Neurorehabilitation Center, Hefei Changxing Rehabilitation Hospital, Hefei, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Pediatric Neurorehabilitation Center, Hefei Changxing Rehabilitation Hospital, Hefei, China.'}, {'ForeName': 'Shizhu', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': ""Pediatric Neurorehabilitation Center, Lu'an Rehabilitation Hospital, Lu'an, China.""}, {'ForeName': 'De', 'Initials': '', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2022.900214']
2018,35706460,Effect of Green Tea on the Level of Salivary Interleukin-1 Beta in Patients with Chronic Periodontitis: A Randomized Clinical Trial.,"Aim


Interleukin-1 beta (IL-1 β ) is one of the major biomarkers involved in the pathogenesis of chronic periodontitis. The aim of this study was to evaluate the changes in salivary IL-1 β  concentration in patients with chronic periodontitis following daily consumption of green tea.
Methods and Materials


Thirty patients with an average age of 45.8 years suffering from chronic periodontitis were randomly assigned into 2 groups (i.e., experimental and control groups). Besides receiving phase 1 periodontal treatment (scaling and root planning (SRP)), the experimental group drank green tea for a period of 6 weeks. To measure the concentration of salivary IL-1 β , saliva samples were taken from both groups at 2 time points, i.e., prior to SRP (time point 1 (T0)) and after 6 weeks (time point 2 (T1)). The nonparametric Wilcoxon test was used to examine and compare the changes in the concentration of salivary IL-1 β  in each group relevant to the 2 time points (T0 and T1). Data were submitted to statistical analysis.
Results


At the end of the study period, a significant reduction ( P =0.0001) in the concentration of salivary IL-1 β  was observed in the experimental group ( A ). As for the control group ( B ), however, there was no significant change ( P =0.307) in the concentration of salivary IL-1 β  after 6 weeks following phase 1 periodontal treatment.
Conclusion


Green tea supplementation, in addition to SRP, may reduce salivary IL-1 β  levels in patients with chronic periodontitis for a period of 6 weeks.",2022,"As for the control group ( B ), however, there was no significant change ( P =0.307) in the concentration of salivary IL-1 β  after 6 weeks following phase 1 periodontal treatment.
","['patients with chronic periodontitis following daily consumption of green tea', 'Thirty patients with an average age of 45.8 years suffering from chronic periodontitis', 'Patients with Chronic Periodontitis', 'patients with chronic periodontitis']","['Green Tea', 'periodontal treatment (scaling and root planning (SRP', 'Interleukin-1 beta (IL-1 β ']","['concentration of salivary IL-1 β', 'Level of Salivary Interleukin-1 Beta', 'concentration of salivary IL-1 β , saliva samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",30.0,0.148205,"As for the control group ( B ), however, there was no significant change ( P =0.307) in the concentration of salivary IL-1 β  after 6 weeks following phase 1 periodontal treatment.
","[{'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Rezvani', 'Affiliation': 'Department of Oral & Maxillofacial Pathology, Faculty of Dentistry, Shahed University, Tehran, Iran.'}, {'ForeName': 'Ferial', 'Initials': 'F', 'LastName': 'Taleghani', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Shahed University, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Valizadeh', 'Affiliation': 'Faculty of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",International journal of dentistry,['10.1155/2022/8992313']
2019,35706448,Psychosocial Effects of Receiving Genome-Wide Polygenic Risk Information Concerning Type 2 Diabetes and Coronary Heart Disease: A Randomized Controlled Trial.,"Receiving polygenic risk estimates of future disease through health care or direct-to-consumer companies is expected to become more common in the coming decades. However, only a limited number of studies have examined if such estimates might evoke an adverse psychosocial reaction in receivers. The present study utilized data from a sub-section of a personalized medicine project (the P5 study) that combines genomic and traditional health data to evaluate participants' risk for certain common diseases. We investigated how communication of future disease risk estimates related to type 2 diabetes and coronary heart disease influenced respondents' risk perception, self-efficacy, disease-related worry, and other emotions. A randomized controlled trial was conducted, where the experimental group (n = 714) received risk estimates based on traditional and polygenic risk factors and the control group (n = 649) based solely on traditional risk factors. On average, higher disease risk was associated with higher perceived risk ( p s, <0.001, η p   2  = 0.087-0.071), worry ( p s <0.001, η p   2  = 0.061-0.028), lower self-efficacy ( p  <0 .001, η p   2  = 0.012), less positive emotions ( p s <0.04, η p   2  = 0.042-0.005), and more negative emotions ( p s <0.048, η p   2  = 0.062-0.006). However, we found no evidence that adding the polygenic risk to complement the more traditional risk factors would induce any substantive psychosocial harm to the recipients ( p s >0.06).",2022,"On average, higher disease risk was associated with higher perceived risk ( p s, <0.001, η p   2  = 0.087-0.071), worry ( p s <0.001, η p   2  = 0.061-0.028), lower self-efficacy ( p  <0 .001, η p   2  = 0.012), less positive emotions ( p s <0.04, η p   2  = 0.042-0.005), and more negative emotions ( p s <0.048, η p   2  = 0.062-0.006).","['Type 2 Diabetes and Coronary Heart Disease', ""participants' risk for certain common diseases"", 'experimental group (n = 714) received risk estimates based on traditional and polygenic risk factors and the control group (n = 649) based solely on traditional risk factors']",[],"['lower self-efficacy', 'negative emotions', 'positive emotions']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2712043', 'cui_str': 'Lacking belief in own ability'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0992635,"On average, higher disease risk was associated with higher perceived risk ( p s, <0.001, η p   2  = 0.087-0.071), worry ( p s <0.001, η p   2  = 0.061-0.028), lower self-efficacy ( p  <0 .001, η p   2  = 0.012), less positive emotions ( p s <0.04, η p   2  = 0.042-0.005), and more negative emotions ( p s <0.048, η p   2  = 0.062-0.006).","[{'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Halmesvaara', 'Affiliation': 'Social Psychology, Faculty of Social Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Marleena', 'Initials': 'M', 'LastName': 'Vornanen', 'Affiliation': 'Social Psychology, Faculty of Social Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Kääriäinen', 'Affiliation': 'Department of Public Health and Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Perola', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Kristiansson', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Konttinen', 'Affiliation': 'Social Psychology, Faculty of Social Sciences, University of Helsinki, Helsinki, Finland.'}]",Frontiers in genetics,['10.3389/fgene.2022.881349']
2020,35706444,A Nomogram for Predicting the Risk of Bone Metastasis in Newly Diagnosed Head and Neck Cancer Patients: A Real-World Data Retrospective Cohort Study From SEER Database.,"Background:  Bone metastasis (BM) is one of the typical metastatic types of head and neck cancer (HNC). The occurrence of BM prevents the HNC patients from obtaining a long survival period. Early assessment of the possibility of BM could bring more therapy options for HNC patients, as well as a longer overall survival time. This study aims to identify independent BM risk factors and develop a diagnostic nomogram to predict BM risk in HNC patients.  Methods:  Patients diagnosed with HNC between 2010 and 2015 were retrospectively evaluated in the Surveillance, Epidemiology, and End Results (SEER) database, and then eligible patients were enrolled in our study. First, those patients were randomly assigned to training and validation sets in a 7:3 ratio. Second, univariate and multivariate logistic regression analyses were used to determine the HNC patients' independent BM risk factors. Finally, the diagnostic nomogram's risk prediction capacity and clinical application value were assessed using calibration curves, receiver operating characteristic (ROC), and decision curve analysis (DCA) curves.  Results:  39,561 HNC patients were enrolled in the study, and they were randomly divided into two sets: training ( n  = 27,693) and validation ( n  = 11,868). According to multivariate logistic regression analysis, race, primary site, tumor grade, T stage, N stage, and distant metastases (brain, liver, and lung) were all independent risk predictors of BM in HNC patients. The diagnostic nomogram was created using the above independent risk factors and had a high predictive capacity. The training and validation sets' area under the curves (AUC) were 0.893 and 0.850, respectively. The AUC values of independent risk predictors were all smaller than that of the constructed diagnostic nomogram. Meanwhile, the calibration curve and DCA also proved the reliability and accuracy of the diagnostic nomogram.  Conclusion:  The diagnostic nomogram can quickly assess the probability of BM in HNC patients, help doctors allocate medical resources more reasonably, and achieve personalized management, especially for HNC patients with a potentially high BM risk, thus acquiring better early education, early detection, and early diagnosis and treatment to maximize the benefits of patients.",2022,"The diagnostic nomogram can quickly assess the probability of BM in HNC patients, help doctors allocate medical resources more reasonably, and achieve personalized management, especially for HNC patients with a potentially high BM risk, thus acquiring better early education, early detection, and early diagnosis and treatment to maximize the benefits of patients.","['Newly Diagnosed Head and Neck Cancer Patients', 'HNC patients with a potentially high BM risk', 'Patients diagnosed with HNC between 2010 and 2015 were retrospectively evaluated in the Surveillance, Epidemiology, and End Results (SEER) database, and then eligible patients were enrolled in our study', '39,561 HNC patients', 'HNC patients']",[],"['overall survival time', 'calibration curves, receiver operating characteristic (ROC), and decision curve analysis (DCA) curves']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1721358', 'cui_str': 'MMP8 protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",39561.0,0.0390784,"The diagnostic nomogram can quickly assess the probability of BM in HNC patients, help doctors allocate medical resources more reasonably, and achieve personalized management, especially for HNC patients with a potentially high BM risk, thus acquiring better early education, early detection, and early diagnosis and treatment to maximize the benefits of patients.","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Zichuan', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedics, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Zongke', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Orthopedics, West China Hospital of Sichuan University, Chengdu, China.'}]",Frontiers in genetics,['10.3389/fgene.2022.865418']
2021,35706879,Effectiveness of Mobile Application for Promotion of Physical Activity Among Newly Diagnosed Patients of Type II Diabetes - A Randomized Controlled Trial.,"Background


Mobile health intervention shows the positive effects on the management of chronic diseases. Therefore, the study was planned to study the effectiveness of a mobile-based application promotion of physical activity among newly diagnosed patients with type II diabetes.
Methods


The present study was a parallel-design randomized controlled trial conducted over 2 years. The participants were type II diabetes patients between 18 and 60 years within 3 months of diagnosis who attended the endocrinology outpatient department having knowledge of using smart phone. The sample size was calculated to be 66 and 33 for each arm. The block random design method was adopted for allocation into different arms. A pretested interview schedule was used for the collection of data. Outcomes included body mass index, waist circumference, body fat percentage, and changes in the physical activity was obtained by global physical activity questionnaire (GPAQ). The information thus collected were processed and analyzed using SPSS v 20.
Results


The study included 66 patients aged between 18 and 60 years, out of which 33 were enrolled into control and 33 into intervention group. The mean age of the participants was 42.29 ± 9.5 years ranged from 25 years to 59 years, 65.2% were males and 34.8% were females. It was observed that a higher proportion of intervention participants met WHO recommendations of physical activity level. Total metabolic equivalent of task (MET) value per minute (Mean ± SD) was 1347.27 ± 1028.5 in the control group and 1223.03 ± 584.87 in intervention group at baseline and was not different ( P  = 0.538). The total MET value per minute was found to be higher among the intervention group in all follow-ups. There was a significant decrease in weight, BMI, waist circumference, hip circumference, body fat percentage, and systolic blood pressure (SBP) in the intervention group.
Conclusions


Cost-effective, simple mobile applications may help in routine clinical practice to encourage the patients for the promotion of physical activity.",2022,The total MET value per minute was found to be higher among the intervention group in all follow-ups.,"['participants were type II diabetes patients between 18 and 60 years within 3 months of diagnosis who attended the endocrinology outpatient department having knowledge of using smart phone', 'Newly Diagnosed Patients of Type II Diabetes ', '66 patients aged between 18 and 60 years, out of which 33 were enrolled into control and 33 into intervention group', 'newly diagnosed patients with type II diabetes', 'The mean age of the participants was 42.29 ± 9.5 years ranged from 25 years to 59 years, 65.2% were males and 34.8% were females']","['Mobile Application', 'mobile-based application promotion']","['global physical activity questionnaire (GPAQ', 'weight, BMI, waist circumference, hip circumference, body fat percentage, and systolic blood pressure (SBP', 'total MET value per minute', 'Total metabolic equivalent of task (MET) value per minute (Mean ± SD', 'body mass index, waist circumference, body fat percentage, and changes in the physical activity']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2983100', 'cui_str': 'Metabolic equivalent of task'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",66.0,0.0277379,The total MET value per minute was found to be higher among the intervention group in all follow-ups.,"[{'ForeName': 'Lipilekha', 'Initials': 'L', 'LastName': 'Patnaik', 'Affiliation': ""Department of Community Medicine, IMS and SUM Hospital, Siksha 'O' Anusandhan Deemed to be University, Khordha, Bhubaneswar, Odisha, India.""}, {'ForeName': 'Sandeep Kumar', 'Initials': 'SK', 'LastName': 'Panigrahi', 'Affiliation': ""Department of Community Medicine, IMS and SUM Hospital, Siksha 'O' Anusandhan Deemed to be University, Khordha, Bhubaneswar, Odisha, India.""}, {'ForeName': 'Abhay Kumar', 'Initials': 'AK', 'LastName': 'Sahoo', 'Affiliation': ""Department of Endocrinology, IMS and SUM Hospital, Siksha 'O' Anusandhan Deemed to be University, Khordha, Bhubaneswar, Odisha, India.""}, {'ForeName': 'Debahuti', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': ""Department of Computer Science, Institute of Technical Education and Research, Siksha 'O'Anusandhan deemed to be University, Khordha, Odisha, India.""}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Muduli', 'Affiliation': ""Department of Community Medicine, IMS and SUM Hospital, Siksha 'O' Anusandhan Deemed to be University, Khordha, Bhubaneswar, Odisha, India.""}, {'ForeName': 'Saswatika', 'Initials': 'S', 'LastName': 'Beura', 'Affiliation': ""Department of Community Medicine, IMS and SUM Hospital, Siksha 'O' Anusandhan Deemed to be University, Khordha, Bhubaneswar, Odisha, India.""}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_92_20']
2022,35706870,"Effect of Selenium on Triglyceride and Total Cholesterol, Weight Gain, and Physical Activity on Hemodialysis Patients: A Randomized Double-Blinded Controlled Trial.","Background


End-stage renal disease is one of the most important chronic diseases. Selenium is one of the so-called rare elements which are essential for our body functions. Here, we aimed to investigate and the effects of selenium supplement therapy on weight gain, physical activity, and triglyceride (TG) and total cholesterol in patients under hemodialysis.
Methods


The current study is a double-blinded clinical trial performed on patients with ESRD under hemodialysis in 2019. In the beginning, serum selenium levels were assessed. All patients were randomly divided into two groups. The first group was under treatments with tablets of selenium 400 μg. Patients received selenium tablets three times after each hemodialysis session (3 times a week) and the other group received placebo tablets. 3 months after the beginning of the study, blood selenium levels, TG and total cholesterol, and weight and physical activities of patients were evaluated again and compared with the beginning.
Results


A total of 78 patients were included. Serum selenium levels at the beginning of our study were 40.06 ± 8.50 in the intervention group and 45.00 ± 8.16 in control groups. Selenium levels and physical activities of patients were increased significantly in intervention group compared to baseline ( P  < 0.001 for both). Weight, physical activity, total cholesterol, and TG in both intervention and control groups did not change significantly after interventions ( P  > 0.05).
Conclusions


We showed that selenium supplement therapies have beneficial effects in patients under hemodialysis. Furthermore, we showed that selenium supplement therapies have positive effects on serum selenium levels but no effects on total cholesterol and TG.",2022,Selenium levels and physical activities of patients were increased significantly in intervention group compared to baseline ( P  < 0.001 for both).,"['A total of 78 patients were included', 'Hemodialysis Patients', 'patients under hemodialysis', 'patients with ESRD under hemodialysis in 2019']","['Selenium', 'selenium supplement therapy', 'selenium supplement therapies', 'placebo tablets', 'selenium tablets']","['weight gain, physical activity, and triglyceride (TG) and total cholesterol', 'total cholesterol and TG', 'Triglyceride and Total Cholesterol, Weight Gain, and Physical Activity', 'serum selenium levels', 'Weight, physical activity, total cholesterol, and TG', 'Selenium levels and physical activities', 'Serum selenium levels', 'blood selenium levels, TG and total cholesterol, and weight and physical activities']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C3661571', 'cui_str': 'Selenium supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0455308', 'cui_str': 'Serum selenium measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0373721', 'cui_str': 'Selenium measurement'}, {'cui': 'C0853177', 'cui_str': 'Blood selenium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",78.0,0.0358471,Selenium levels and physical activities of patients were increased significantly in intervention group compared to baseline ( P  < 0.001 for both).,"[{'ForeName': 'Abdolamir', 'Initials': 'A', 'LastName': 'Atapour', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Vahdat', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohamadian', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_378_20']
2023,35706801,Identification of a three-miRNA panel in serum for bladder cancer diagnosis by a diagnostic test.,"Background


Bladder cancer (BC) is the tenth most common cancer in the world. Serum microRNA (miRNA) profiles previously have been reported as non-invasive biomarkers in cancer screening. The non-invasive and reliable diagnostic biomarkers are urgently needed for detecting BC, while cystoscopy is invasive. Our study aimed to identify candidate miRNAs in serum as potential diagnostic biomarkers for BC detection.
Methods


This study was including the screening stage, training stage, and validation stage with 137 BC patients and 127 healthy controls (HCs). We identified the expression of 28 serum miRNAs from 5 BC pools and 3 HC pools in the initial screening stage. The other 112 BC patients and 112 HCs were randomly divided into training stage with 30 BC patients and 30 HCs and validation stages with 82 BC patients and 82 HCs. These HCs matched BC patients based on age and gender with P value >0.05. Identified dysregulated miRNAs were further confirmed in the training stage, and validation stages by quantitative reverse transcription-polymerase chain reaction (qRT-PCR). The diagnostic value of miRNAs was assessed by receiver operating characteristic (ROC) curves and the area under the ROC curve (AUC). Target genes of 3 candidate miRNAs were predicted by bioinformatic analysis.
Results


Five miRNAs (miR-106a-5p, miR-145-5p, miR-132-3p, miR-7-5p and miR-148b-3p) in serum were obviously dysregulated in BC patients compared to HCs. The ability to diagnose BC of 3 candidate miRNAs was estimated by AUC, with miR-132-3p (AUC =0.781; sensitivity =68.29%, specificity =81.71%), miR-7-5p (AUC =0.778; sensitivity =59.76%, specificity =84.15%) and miR-148b-3p (AUC =0.837; sensitivity =81.71%, specificity =71.95%). Combined application of these candidate miRNAs with parallel test could improve the diagnostic value (AUC =0.922; sensitivity =90.24%, specificity =81.71%).  BNC2, GAS7 , and  NTRK2 , considered as target genes of the three-miRNA panel, may play an important role in the process of BC development.
Conclusions


A three-miRNA panel in serum was identified for BC diagnosis in our study, which HCs were used for differential diagnosis. The three-miRNA panel (miR-132-3p, miR-7-5p, and miR-148b-3p) might be performed as a non-invasive and convenient diagnostic tool for BC screening and diagnosis.",2022,"Combined application of these candidate miRNAs with parallel test could improve the diagnostic value (AUC =0.922; sensitivity =90.24%, specificity =81.71%).  ","['112 BC patients and 112 HCs', '137 BC patients and 127 healthy controls (HCs']","['miR-106a-5p, miR-145-5p, miR-132-3p, miR-7-5p and miR-148b-3p']","['receiver operating characteristic (ROC) curves and the area under the ROC curve (AUC', 'diagnostic value']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517569', 'cui_str': '137'}]","[{'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1741325', 'cui_str': 'LILRB1 protein, human'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",137.0,0.0803342,"Combined application of these candidate miRNAs with parallel test could improve the diagnostic value (AUC =0.922; sensitivity =90.24%, specificity =81.71%).  ","[{'ForeName': 'Rongkang', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Guangdong and Shenzhen Key Laboratory of Male Reproductive Medicine and Genetics, Peking University Shenzhen Hospital, Clinical College of Anhui Medical University, Shenzhen, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Guangdong and Shenzhen Key Laboratory of Male Reproductive Medicine and Genetics, Peking University Shenzhen Hospital, Clinical College of Anhui Medical University, Shenzhen, China.'}, {'ForeName': 'Xinji', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Guangdong and Shenzhen Key Laboratory of Male Reproductive Medicine and Genetics, Peking University Shenzhen Hospital, Clinical College of Anhui Medical University, Shenzhen, China.'}, {'ForeName': 'Guocheng', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, Guangdong and Shenzhen Key Laboratory of Male Reproductive Medicine and Genetics, Peking University Shenzhen Hospital, Clinical College of Anhui Medical University, Shenzhen, China.'}, {'ForeName': 'Xiqi', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Urology, Guangdong and Shenzhen Key Laboratory of Male Reproductive Medicine and Genetics, Peking University Shenzhen Hospital, Clinical College of Anhui Medical University, Shenzhen, China.'}, {'ForeName': 'Kaihao', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Guangdong and Shenzhen Key Laboratory of Male Reproductive Medicine and Genetics, Peking University Shenzhen Hospital, Clinical College of Anhui Medical University, Shenzhen, China.'}, {'ForeName': 'Chunduo', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Guangdong and Shenzhen Key Laboratory of Male Reproductive Medicine and Genetics, Peking University Shenzhen Hospital, Clinical College of Anhui Medical University, Shenzhen, China.'}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Yongqing', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Department of Urology, Guangdong and Shenzhen Key Laboratory of Male Reproductive Medicine and Genetics, Peking University Shenzhen Hospital, Clinical College of Anhui Medical University, Shenzhen, China.'}]",Translational cancer research,['10.21037/tcr-21-2611']
2024,35706754,Randomized Clinical Trial on the Efficacy of Triple Therapy Versus Sequential Therapy in Helicobacter pylori Eradication.,"INTRODUCTION


Helicobacter pylori  ( H. pylori ) colonization is prevalent all over the world, and it is associated with low socioeconomic status, poor hygiene, and overcrowding. Its eradication is important since it is an etiologic agent for gastritis, peptic ulcer, gastric carcinoma, and mucosa-associated lymphoid tissue lymphoma. Different regimens are available for the eradication of  H. pylori  and include triple therapy and sequential therapy. Our study aims to compare the efficacy of triple therapy versus sequential therapy in the eradication of  H. pylori .
MATERIAL AND METHODS


This randomized clinical trial was conducted at the Pakistan Institute of Medical Sciences Hospital, Islamabad, from September 2016 to September 2017 after the approval of the institutional review board. A total of 160 patients were enrolled and equally divided into two, group A and group B. A twice-daily dose of amoxicillin 1,000 mg, rabeprazole 20 mg, and clarithromycin 500 mg was given to group A for 10 days, while group B was initially given rabeprazole 20 mg and amoxicillin 1,000 mg two times daily for the first five days (i.e., induction phase), followed by triple therapy that included rabeprazole 20 mg, clarithromycin 500 mg, and metronidazole/tinidazole 500 mg twice daily for the next five days. A negative stool antigen test performed four weeks after the completion of therapy was considered an effective eradication. A proforma was used to collect data that included age, gender, city or province of residence, family income, group (group A or group B), and eradication efficacy. Analysis of the data was performed using the Statistical Package for the Social Sciences version 17 (SPSS Inc., Chicago, USA).
RESULTS


A total of 160 patients were included, with mean age and standard deviation of 40.02±24.4 years. The male/female ratio was 1.8:1. Successful eradication of  H. pylori  achieved in group A was 67.5% (N=54) in comparison to group B, which was 95% (N=76) (p=0.001).
CONCLUSION


Sequential therapy was superior to triple therapy in  H. pylori  eradication.",2022,"Successful eradication of  H. pylori  achieved in group A was 67.5% (N=54) in comparison to group B, which was 95% (N=76) (p=0.001).
","['A total of 160 patients were included, with mean age and standard deviation of 40.02±24.4 years', 'Pakistan Institute of Medical Sciences Hospital, Islamabad, from September 2016 to September 2017 after the approval of the institutional review board', '160 patients']","['amoxicillin 1,000 mg, rabeprazole 20 mg, and clarithromycin', 'rabeprazole 20 mg,\xa0clarithromycin 500 mg, and metronidazole/tinidazole', 'Triple Therapy Versus Sequential Therapy', 'rabeprazole 20 mg and amoxicillin']","['Successful eradication of  H. pylori', 'Helicobacter pylori Eradication', 'eradication efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0040263', 'cui_str': 'Tinidazole'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",160.0,0.017693,"Successful eradication of  H. pylori  achieved in group A was 67.5% (N=54) in comparison to group B, which was 95% (N=76) (p=0.001).
","[{'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Sharif', 'Affiliation': 'Gastroenterology, Nishtar Hospital Multan, Multan, PAK.'}, {'ForeName': 'Muaz', 'Initials': 'M', 'LastName': 'Mubashir', 'Affiliation': 'Internal Medicine, Federal Government Polyclinic Hospital, Islamabad, PAK.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Naqvi', 'Affiliation': 'Internal Medicine/Gastroenterology, Federal Government Polyclinic Hospital, Islamabad, PAK.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Atique', 'Affiliation': 'Internal Medicine, Federal Government Polyclinic Hospital, Islamabad, PAK.'}, {'ForeName': 'Saira', 'Initials': 'S', 'LastName': 'Mahmood', 'Affiliation': 'General Surgery, Maroof International Hospital, Islamabad, PAK.'}, {'ForeName': 'Muneeb', 'Initials': 'M', 'LastName': 'Ullah', 'Affiliation': 'General Surgery, Maroof International Hospital, Islamabad, PAK.'}]",Cureus,['10.7759/cureus.24897']
2025,35706748,"Anesthetic Stability of Propofol, Dexmedetomidine, and Isoflurane by Measuring Bispectral Index (BIS) and Hemodynamic Indices: A Comparative Study.","Background Hemodynamic changes and anesthetic awareness occurring during surgery under general anesthesia is a great concern for both surgeon and anesthesiologist. Maintenance of the adequate depth of anesthesia throughout the intraoperative period is important in maintaining hemodynamic stability, preventing intraoperative awareness, and avoiding postoperative recall. Aim This study aims to predict the anesthetic stability of propofol, dexmedetomidine, and isoflurane by measuring bispectral index (BIS) and hemodynamic indices. Materials and methods This is a prospective comparative study. Sixty patients of either sex, aged 18-60 years, with American Society of Anesthesiologist (ASA) physical status classification I and II, undergoing elective surgical procedures requiring general anesthesia were allocated into three groups of 20 each. Patients in each group were administered standard general anesthesia with routine hemodynamic monitoring along with BIS, and values were recorded at baseline and thereafter at every five-minute interval for the duration of surgery. Anesthesia was maintained in Group P using a bolus dose of propofol 1 milligram.kg -1  for 10 minutes followed by propofol infusion 50-75 microgram.kg -1 .minute -1 , Group D with a bolus dose of dexmedetomidine 1 microgram.kg -1  for 10 minutes followed by infusion 0.2-0.7 microgram.kg -1 .hour -1 , and Group I with isoflurane at 1 minimum alveolar concentration (MAC) for 10 minutes and then maintained between 0.5 MAC and 1.5 MAC until the duration of surgery. To maintain the surgical plane of anesthesia, the BIS score was monitored between 40 and 65. The quantitative variables were expressed as mean±SD and compared between groups using Student's unpaired t-test. Data analysis was done using SPSS Statistics for Windows version 20.0 (IBM Corp., Armonk, NY, USA). A p-value of <0.05 was considered statistically significant. Results During intergroup comparison among study drugs, the mean BIS values were statistically significant among the groups (p<0.05). Hemodynamic indices were significantly better maintained in the dexmedetomidine group as compared to the isoflurane and propofol groups throughout the intraoperative period (p<0.05). Conclusion Dexmedetomidine is better than propofol and isoflurane in maintaining the BIS score and hemodynamic parameters during the intraoperative period.",2022,Hemodynamic indices were significantly better maintained in the dexmedetomidine group as compared to the isoflurane and propofol groups throughout the intraoperative period (p<0.05).,"['I and II, undergoing elective surgical procedures requiring general anesthesia', 'Sixty patients of either sex, aged 18-60 years, with American Society of Anesthesiologist (ASA) physical status classification']","['propofol and isoflurane', 'propofol', 'isoflurane', 'Propofol, Dexmedetomidine, and Isoflurane', 'standard general anesthesia with routine hemodynamic monitoring', 'propofol infusion 50-75 microgram.kg', 'Dexmedetomidine', 'propofol, dexmedetomidine, and isoflurane', 'dexmedetomidine']","['mean BIS values', 'Hemodynamic indices', 'Bispectral Index (BIS) and Hemodynamic Indices', 'BIS score and hemodynamic parameters', 'BIS score', 'bispectral index (BIS) and hemodynamic indices']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",60.0,0.0615616,Hemodynamic indices were significantly better maintained in the dexmedetomidine group as compared to the isoflurane and propofol groups throughout the intraoperative period (p<0.05).,"[{'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Anesthesiology, Uttar Pradesh University of Medical Sciences, Etawah, IND.'}, {'ForeName': 'Atit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Anesthesiology, Uttar Pradesh University of Medical Sciences, Etawah, IND.'}, {'ForeName': 'Jay Brijesh Singh', 'Initials': 'JBS', 'LastName': 'Yadav', 'Affiliation': 'Anesthesiology, Uttar Pradesh University of Medical Sciences, Etawah, IND.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Bhardwaj', 'Affiliation': 'Anesthesiology, Uttar Pradesh University of Medical Sciences, Etawah, IND.'}, {'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Anesthesiology, Uttar Pradesh University of Medical Sciences, Etawah, IND.'}]",Cureus,['10.7759/cureus.24930']
2026,35706706,Development and feasibility of culturally sensitive family-oriented dignity therapy for Chinese patients with lung cancer undergoing chemotherapy.,"Objective


It is well-documented in the literature that dignity therapy is feasible and effectively improves the end-of-life experience of the terminally ill. In a similar vein, this study aimed to develop and investigate the feasibility of evidence-based and culturally sensitive family-oriented dignity therapy for Chinese patients with lung cancer undergoing chemotherapy.
Methods


Three phases of the Medical Research Council framework were adopted to guide the development of the novel dignity therapy intervention. It was preliminarily designed based on a qualitative study and a systematic review, Erikson's eighth stage of psychosocial development, and the dignity model. The feasibility and acceptability of the intervention were examined in a pilot randomized controlled trial with 12 recruited dyads of patients and family caregivers.
Results


The intervention consists of three face-to-face sessions that facilitate participants' reminiscences and promote their communication. Recruitment and response rates for the feasibility study of the intervention were 92.3% and 75%, respectively. Both patients and family caregivers reported that the intervention alleviated their psychological distress and improved communication.
Conclusions


The Medical Research Council framework serves as a useful scientific basis for modifying dignity therapy with a culturally sensitive approach. The results of the feasibility study suggest that the family-oriented dignity therapy intervention is feasible, acceptable and has the potential to enhance the effects of dignity therapy.",2022,"The results of the feasibility study suggest that the family-oriented dignity therapy intervention is feasible, acceptable and has the potential to enhance the effects of dignity therapy.","['Chinese patients with lung cancer undergoing chemotherapy', '12 recruited dyads of patients and family caregivers']","['culturally sensitive family-oriented dignity therapy', 'dignity therapy intervention', 'evidence-based and culturally sensitive family-oriented dignity therapy']","['feasibility and acceptability', 'psychological distress and improved communication', 'Recruitment and response rates']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]",12.0,0.0477586,"The results of the feasibility study suggest that the family-oriented dignity therapy intervention is feasible, acceptable and has the potential to enhance the effects of dignity therapy.","[{'ForeName': 'Jinnan', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, China.'}, {'ForeName': 'Ka Ming', 'Initials': 'KM', 'LastName': 'Chow', 'Affiliation': 'The Nerthersole School of Nursing, Faculty of Medicine, The Chinese University of Hong, Hong Kong SAR, China.'}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, China.'}, {'ForeName': 'Carmen Wh', 'Initials': 'CW', 'LastName': 'Chan', 'Affiliation': 'The Nerthersole School of Nursing, Faculty of Medicine, The Chinese University of Hong, Hong Kong SAR, China.'}]",Asia-Pacific journal of oncology nursing,['10.1016/j.apjon.2022.100078']
2027,35707064,Use of Clinical Global Impressions-Severity (CGI-S) to Assess Response to Antidepressant Treatment in Patients with Treatment-Resistant Depression.,"Background


This post-hoc analysis evaluated the agreement between Clinical Global Impressions-Severity (CGI-S) score- and Montgomery-Åsberg Depression Rating Scale (MADRS) total score-based assessment of response in patients with treatment-resistant depression (TRD) treated with esketamine nasal spray plus a newly initiated oral antidepressant (ESK-NS + AD).
Methods


Data were analyzed from a phase 3, randomized, double-blind study (TRANSFORM-2) of flexibly dosed esketamine or placebo nasal spray plus a newly initiated oral-AD in adults with moderate-to-severe TRD. Patients with ≥50% reduction in MADRS from baseline at the end of the 4-week acute treatment phase were defined as responders. For the CGI-S-based assessment of response, patients with ≥2 points decrease from baseline or a CGI-S score of ≤3 (mildly depressed to normal) were considered responders. Cohen's kappa coefficient was calculated to assess level of agreement between MADRS and CGI-S-based assessments.
Results


At the end of 4-week treatment, the proportion of responders among all study patients (n=201) was similar when assessed using the MADRS (61%) and CGI-S (62%) methods, with substantial agreement (Cohen's kappa=0.76; sensitivity=92%; specificity=84%) between both methods. When restricting analysis to ESK-NS + AD-treated patients (n=101) who had a higher response rate (on MADRS: 69%; on CGI-S: 68%), the agreement remained substantial (Cohen's kappa=0.75; sensitivity=91%; specificity=84%).
Conclusion


The CGI-S may be a practical and reliable alternative to the MADRS to assess response to ESK-NS + AD in patients with TRD and can be used in real-world practice to support informed treatment decisions.",2022,The CGI-S may be a practical and reliable alternative to the MADRS to assess response to ESK-NS + AD in patients with TRD and can be used in real-world practice to support informed treatment decisions.,"['patients with TRD', 'patients with treatment-resistant depression (TRD) treated with', 'Patients with Treatment-Resistant Depression', 'adults with moderate-to-severe TRD']","['esketamine nasal spray plus a newly initiated oral antidepressant (ESK-NS + AD', 'esketamine or placebo nasal spray plus a newly initiated oral-AD']","['CGI-S score', 'MADRS', 'response rate', 'Clinical Global Impressions-Severity (CGI-S) score- and Montgomery-Åsberg Depression Rating Scale (MADRS) total score-based assessment of response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087050', 'cui_str': 'T-Cell Receptor delta-Chain'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0909896,The CGI-S may be a practical and reliable alternative to the MADRS to assess response to ESK-NS + AD in patients with TRD and can be used in real-world practice to support informed treatment decisions.,"[{'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Morrens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Maju', 'Initials': 'M', 'LastName': 'Mathews', 'Affiliation': 'Janssen Global Services, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Vanina', 'Initials': 'V', 'LastName': 'Popova', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Borentain', 'Affiliation': 'Janssen Global Services, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Rive', 'Affiliation': 'Janssen-Cilag, Paris, France.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Gonzalez Martin Moro', 'Affiliation': 'Janssen-Cilag, Madrid, Spain.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Jamieson', 'Affiliation': 'Janssen Research & Development, LLC, Milpitas, CA, USA.'}, {'ForeName': 'Qiaoyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Janssen Global Services, LLC, Titusville, NJ, USA.'}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S358367']
2028,35707055,"Comparison of Effects of Mothers' and Mozart's Lullabies on Physiological Responses, Feeding Volume, and Body Weight of Premature Infants in NICU.","Objectives


The purpose of this study was to compare the effects of mothers' and Mozart's lullabies on physiological parameters, feeding volume, and body weight of premature infants in a neonatal intensive care unit (NICU).
Methods


This study used a non-equivalent control group, non-synchronized design as a quasi-experimental study. Two intervention groups (recorded mother's lullaby and Mozart's lullaby) and a control group were formed from a total of 65 premature infants: a mother's lullaby group of 22 infants, a Mozart's lullaby group of 22 infants, and a control group of 21 infants not provided with any lullabies. Their physiological parameters included heart rate, blood pressure, respiratory rate, and O 2  saturation. The infants' feeding volume and body weight were measured as indicators related to the growth of premature infants. The mother's and Mozart's lullabies were played on a speaker in an incubator for 15 min for 7 consecutive days per group.
Results


There were significant differences in the mean difference before and after intervention in neonatal heart rate (χ 2  = 45.03,  P  < 0.001), systolic pressure (F = 43.29,  P  < 0.001), diastolic pressure (χ 2  = 33.01,  P  < 0.001), respiratory rate (F = 76.06,  P  < 0.001), and O 2  saturation (χ 2  = 40.82,  P  < 0.001) between the three groups. The mean differences of both mother's and Mozart's lullaby groups were significantly higher than those of the routine care group in all physiological parameters, and those of the mother's lullaby group was significantly higher when compared with the Mozart's lullaby group. In repeated-measures ANOVA, there was a significant interaction between time and group in feeding volume (F = 2.46,  P  = 0.041). However, body weight did not significantly differ in an interaction between time and group (F = 1.75,  P  = 0.151).
Conclusion


This study showed beneficial effects of mother's lullaby and Mozart's lullaby on physiological parameters. Especially, the mother's lullaby was found to significantly improve all physiological parameters and feeding volume of premature infants in the NICU compared to Mozart's lullaby group. Therefore, we recommend the regular integration of the mother's lullaby into supportive care of premature infants in the NICU, as this intervention highlights the need for mothers to participate in their care.
Trial Registration


ClinicalTrials.gov, identifier: KCT0004842 (https://cris.nih.go.kr).",2022,"There were significant differences in the mean difference before and after intervention in neonatal heart rate (χ 2  = 45.03,  P  < 0.001), systolic pressure (F = 43.29,  P  < 0.001), diastolic pressure (χ 2  = 33.01,  P  < 0.001), respiratory rate (F = 76.06,  P  < 0.001), and O 2  saturation (χ 2  = 40.82,  P  < 0.001) between the three groups.","['premature infants in a neonatal intensive care unit (NICU', 'Premature Infants in NICU', ""65 premature infants: a mother's lullaby group of 22 infants, a Mozart's lullaby group of 22 infants, and a control group of 21 infants not provided with any lullabies""]","[""Mothers' and Mozart's Lullabies"", ""mothers' and Mozart's lullabies"", ""mother's lullaby and Mozart's lullaby""]","['physiological parameters, feeding volume, and body weight', 'systolic pressure', 'respiratory rate', 'feeding volume and body weight', 'neonatal heart rate', 'diastolic pressure', 'body weight', 'physiological parameters and feeding volume', 'feeding volume', 'Physiological Responses, Feeding Volume, and Body Weight', 'heart rate, blood pressure, respiratory rate, and O 2  saturation']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3661900', 'cui_str': 'Not provided'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}]",65.0,0.0112394,"There were significant differences in the mean difference before and after intervention in neonatal heart rate (χ 2  = 45.03,  P  < 0.001), systolic pressure (F = 43.29,  P  < 0.001), diastolic pressure (χ 2  = 33.01,  P  < 0.001), respiratory rate (F = 76.06,  P  < 0.001), and O 2  saturation (χ 2  = 40.82,  P  < 0.001) between the three groups.","[{'ForeName': 'Hyo-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'College of Nursing, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Jooyeon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Daegu University, Daegu, South Korea.'}, {'ForeName': 'Hye-Kyung', 'Initials': 'HK', 'LastName': 'Oh', 'Affiliation': 'Department of Nursing, Daegu University, Daegu, South Korea.'}, {'ForeName': 'Nahyun', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Keimyung University, Daegu, South Korea.'}]",Frontiers in public health,['10.3389/fpubh.2022.870740']
2029,35707040,Therapeutic Effect and Prognosis of PiCCO in the Treatment of Myocardial Injury Complicated with Septic Shock.,"Objective


To explore the effect of pulse-induced contour cardiac output (PiCCO) monitoring on the survival and prognosis of patients with myocardial injury and septic shock.
Methods


A total of 400 patients with MI and septic shock who were treated in our hospital from May 2018 to June 2021 were included in the study. They were randomly grouped into the PiCCO group ( n  = 200) and the control group ( n  = 200) according to whether PiCCO was used for monitoring during the treatment period. The clinical baseline characteristics of all the patients were recorded. For comparison, we recorded hemodynamic parameters including mean arterial pressure (MAP), central venous pressure (CVP), heart rate (HR), troponin I (TnI), brain natriuretic peptide (BNP), oxygen metabolism parameters including systemic central venous oxygen saturation (ScvO 2 ), and lactate before and 6 h after intervention. In addition, white blood cell count (WBC) and C-reactive protein (CPR) levels before and 6 h, 24 h, 48 h, and 72 h after intervention were measured in both groups. Finally, the survival and prognostic parameters were compared between the two groups.
Results


At 6 h after monitoring intervention, the hemodynamic parameters of the patients in the PiCCO group were significantly increased. Additionally, compared with the control group, the ScvO 2  level was higher while the lactate level was lower in the PiCCO group. An intergroup comparison on inflammation also showed that WBC and CPR levels recovered better in the PiCCO group than in the control group. Moreover, patients with PiCCO monitoring showed better performance in outcome measures such as mortality, duration of invasive mechanical ventilation, length of hospital stay, duration of ventilator use, acute physiology and chronic health scores, and postoperative complications.
Conclusion


With the monitoring and guidance of the PiCCO technique, the nursing outcomes, survival rate, and prognosis of patients with myocardial injury and septic shock can be improved.",2022,"Additionally, compared with the control group, the ScvO 2  level was higher while the lactate level was lower in the PiCCO group.","['Myocardial Injury Complicated with Septic Shock', 'patients with myocardial injury and septic shock', '400 patients with MI and septic shock who were treated in our hospital from May 2018 to June 2021 were included in the study']","['PiCCO', 'pulse-induced contour cardiac output (PiCCO) monitoring']","['lactate level', 'survival rate, and prognosis of patients with myocardial injury and septic shock', 'hemodynamic parameters', 'mean arterial pressure (MAP), central venous pressure (CVP), heart rate (HR), troponin I (TnI), brain natriuretic peptide (BNP), oxygen metabolism parameters including systemic central venous oxygen saturation (ScvO 2 ), and lactate before and 6\u2009h', 'survival and prognostic parameters', 'WBC and CPR levels', 'mortality, duration of invasive mechanical ventilation, length of hospital stay, duration of ventilator use, acute physiology and chronic health scores, and postoperative complications', 'ScvO 2  level', 'white blood cell count (WBC) and C-reactive protein (CPR) levels']","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",400.0,0.0439926,"Additionally, compared with the control group, the ScvO 2  level was higher while the lactate level was lower in the PiCCO group.","[{'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': ""Emergency Intensive Care Unit, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Jiangsu, China.""}, {'ForeName': 'Huaixiang', 'Initials': 'H', 'LastName': 'Zhai', 'Affiliation': ""Intensive Care Unit, The First People's Hospital of Lianyungang, Jiangsu, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Emergency Intensive Care Unit, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Jiangsu, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Su', 'Affiliation': ""Emergency Intensive Care Unit, The First People's Hospital of Lianyungang, Jiangsu, China.""}, {'ForeName': 'Yongpeng', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ""Intensive Care Unit, The First People's Hospital of Lianyungang, Jiangsu, China.""}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Emergency Intensive Care Unit, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Jiangsu, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Emergency Intensive Care Unit, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Jiangsu, China.""}, {'ForeName': 'Jiguang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Emergency Intensive Care Unit, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Jiangsu, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""Department of Emergency and Critical Medicine, The First People's Hospital of Lianyungang, Jiangsu, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/2910849']
2030,35707385,"The Effect of an Educational Intervention on Oral Health Literacy, Knowledge, and Behavior in Iranian Adolescents: A Theory-Based Randomized Controlled Trial.","Introduction


Oral health is one of the most important issues in public health. Most educational interventions, as the primary prevention strategy, are focused on increasing information and knowledge and are not usually effective. Therefore, the present study is aimed at determining the effect of theory-based education on oral health behavior and its psychological determinants including dental health literacy.
Method


This randomized controlled educational trial was conducted in two girls' high schools that were selected by multistage cluster sampling and were divided into an intervention and a control group. Literacy, knowledge, oral health behavior, dental plaque index, and constructs of the protection motivation theory were evaluated before and one month after four training sessions. Finally, the data were entered into the SPSS 19 software and were analyzed using the chi-square test, independent  t -test, and Mann-Whitney test at the significant level of 0.05.
Result


Before the intervention, there was no significant difference between the intervention and control groups regarding the mean scores of knowledge, behavior, and oral health literacy; plaque index; and protection motivation theory constructs. After the educational intervention, however, the means of these variables were significantly improved in the intervention group compared to the controls ( p  < 0.05).
Conclusion


The study findings were in favor of the effectiveness of the theory-based educational intervention in improving the knowledge, literacy, and behavior related to oral health. Yet, further research is suggested to determine the effectiveness of such an intervention in male students as well as in populations with different socioeconomic and cultural statuses.",2022,"Before the intervention, there was no significant difference between the intervention and control groups regarding the mean scores of knowledge, behavior, and oral health literacy; plaque index; and protection motivation theory constructs.","[""two girls' high schools that were selected by multistage cluster sampling"", 'male students', 'Iranian Adolescents']","['theory-based educational intervention', 'Educational Intervention']","['knowledge, literacy, and behavior related to oral health', 'mean scores of knowledge, behavior, and oral health literacy; plaque index; and protection motivation theory constructs', 'Literacy, knowledge, oral health behavior, dental plaque index, and constructs of the protection motivation theory', 'Oral Health Literacy, Knowledge, and Behavior']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",,0.00866194,"Before the intervention, there was no significant difference between the intervention and control groups regarding the mean scores of knowledge, behavior, and oral health literacy; plaque index; and protection motivation theory constructs.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Movaseghi Ardekani', 'Affiliation': 'Department of Health Promotion, Faculty of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Kaveh', 'Affiliation': 'Research Center for Health Sciences, Institute of Health, Department of Health Promotion, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Nazari', 'Affiliation': 'Research Center for Health Sciences, Institute of Health, Department of Health Promotion, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zakieh', 'Initials': 'Z', 'LastName': 'Khoramaki', 'Affiliation': 'Student Research Committee, Department of Health Promotion, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",BioMed research international,['10.1155/2022/5421799']
2031,35707344,Resource mobilization combined with motivational interviewing to promote healthy behaviors and healthy weight in low-income families: An intervention feasibility study.,"Objectives


This non-randomized pilot trial examined the feasibility and acceptability of an intervention for low-income families with one parent with obesity, glucose intolerance and/or diabetes.
Methods


The 12-month intervention combined health coaching using motivational interviewing to promote lifestyle behavior change and community resource mobilization to assist with basic needs plus diet quality and physical activity. Outcome measures included process measures, open-ended questions, and the Family Nutrition and Physical Activity scale.
Results


Forty-five families completed an average of 2.1 health coach in-person visits, including 15 families lost to follow-up. Parents who stayed in the intervention reported the intervention was helpful. Some families and the health coach had difficulties contacting one another, and some of these families reported they would have liked more sessions with the coach. The Family Nutrition and Physical Activity scores improved significantly for all children (6 months: 2.9; p < .01; 12 months: 3.2; p < .05) and at 6 months for index children (6 months: 3.5; p < .01; 12 months: 2.9; p = .09). There was variation in the FNPA and other outcome changes between families.
Conclusion


This intervention was feasible in terms of recruitment and delivery of family sessions and community referrals and acceptable to participants, but maintaining contact with participants was difficult. Findings warrant improvements to help retention and logistical aspects of communication between families and coaches and testing in a randomized, controlled trial.",2022,The Family Nutrition and Physical Activity scores improved significantly for all children (6 months: 2.9; p < .01; 12 months: 3.2; p < .05) and at 6 months for index children (6 months: 3.5; p < .01; 12 months: 2.9; p = .09).,"['healthy behaviors and healthy weight in low-income families', 'low-income families with one parent with obesity, glucose intolerance and/or diabetes']","['combined health coaching using motivational interviewing', 'Resource mobilization combined with motivational interviewing']","['feasibility and acceptability', 'process measures, open-ended questions, and the Family Nutrition and Physical Activity scale', 'Family Nutrition and Physical Activity scores']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086850', 'cui_str': 'Process Measures'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",45.0,0.0222625,The Family Nutrition and Physical Activity scores improved significantly for all children (6 months: 2.9; p < .01; 12 months: 3.2; p < .05) and at 6 months for index children (6 months: 3.5; p < .01; 12 months: 2.9; p = .09).,"[{'ForeName': 'Helena H', 'Initials': 'HH', 'LastName': 'Laroche', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Kansas City, MO, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Park-Mroch', 'Affiliation': 'Department of Internal Medicine, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': ""O'Shea"", 'Affiliation': 'Department of Internal Medicine, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Sarai', 'Initials': 'S', 'LastName': 'Rice', 'Affiliation': 'Des Moines Area Religious Council (DMARC), Des Moines, IA, USA.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Cintron', 'Affiliation': 'Department of Internal Medicine, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Bery', 'Initials': 'B', 'LastName': 'Engebretsen', 'Affiliation': 'Primary Health Care, Inc., Des Moines, IA, USA.'}]",SAGE open medicine,['10.1177/20503121221102706']
2032,35707316,The Effect of a Combined Modified Pectoral and Stellate Ganglion Block on Stress and Inflammatory Response in Patients Undergoing Modified Radical Mastectomy.,"Background and Aims


Regional anaesthesia reports to attenuate stress and inflammatory responses associated with surgical resection; however, the effectiveness of combined nerve blocks is less often investigated. We evaluated whether a combination of a pectoral nerve block (PNB) and stellate ganglion block (SGB) is more effective than a PNB alone in reducing these responses in women undergoing modified radical mastectomy (MRM).
Methods


This is a prospective randomized controlled trial. Fifty patients with breast cancer were randomly allocated to receive an ultrasound-guided PNB ( n  = 25, PNB only group) or ultrasound-guided PNB combined with SGB ( n  = 25, combined blockade group). The primary outcome was perioperative plasma level of interleukin- (IL-) 6. Secondary outcomes included perioperative plasma levels of cortisol, glucose, IL-8, and tumour necrosis factor- (TNF-)  α , pain scores, haemodynamic variables, sleep quality, and complications postsurgery.
Results


The combined blockade group exhibited significantly lower IL-6 and TNF- α  levels 24 h postsurgery. Cortisol levels were significantly lower in the combined blockade group at the end of the surgery. Glucose levels at the time of incision were lower in the combined blockade group. Pain scores up to 12 h postsurgery were significantly lower in the combined blockade group, which also exhibited better perioperative haemodynamic stability. Patients in the combined blockade group reported better sleep quality on the night of surgery.
Conclusion


In patients undergoing MRM, PNB combined with SGB block effectively blunted perioperative inflammatory response than PNB alone. A combined block approach can also alleviate stress response and postoperative acute pain with stable perioperative haemodynamics and better postoperative sleep quality.",2022,"Pain scores up to 12 h postsurgery were significantly lower in the combined blockade group, which also exhibited better perioperative haemodynamic stability.","['women undergoing modified radical mastectomy (MRM', 'Fifty patients with breast cancer', 'Patients Undergoing Modified Radical Mastectomy']","['ultrasound-guided PNB ( n  = 25, PNB only group) or ultrasound-guided PNB combined with SGB', 'pectoral nerve block (PNB) and stellate ganglion block (SGB', 'PNB alone', 'Combined Modified Pectoral and Stellate Ganglion Block', 'SGB block']","['Pain scores', 'perioperative haemodynamic stability', 'Stress and Inflammatory Response', 'Glucose levels', 'sleep quality', 'perioperative inflammatory response', 'Cortisol levels', 'IL-6 and TNF- α  levels', 'perioperative plasma level of interleukin- (IL-) 6', 'perioperative plasma levels of cortisol, glucose, IL-8, and tumour necrosis factor- (TNF-)  α , pain scores, haemodynamic variables, sleep quality, and complications postsurgery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.186475,"Pain scores up to 12 h postsurgery were significantly lower in the combined blockade group, which also exhibited better perioperative haemodynamic stability.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital Affiliated to Southeast University Medical School, Wuxi, 214400 Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital Affiliated to Southeast University Medical School, Wuxi, 214400 Jiangsu, China.'}, {'ForeName': 'Yaowen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital Affiliated to Southeast University Medical School, Wuxi, 214400 Jiangsu, China.'}, {'ForeName': 'Wenxiang', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital Affiliated to Southeast University Medical School, Wuxi, 214400 Jiangsu, China.'}, {'ForeName': 'Junjia', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Jiangyin Hospital Affiliated to Southeast University Medical School, Wuxi, 214400 Jiangsu, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital Affiliated to Southeast University Medical School, Wuxi, 214400 Jiangsu, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Jiangyin Hospital Affiliated to Southeast University Medical School, Wuxi, 214400 Jiangsu, China.'}]",International journal of breast cancer,['10.1155/2022/3359130']
2033,35707309,A Randomized Comparative Study to Compare Karman's Cannula and Pipelle Biopsy for Evaluation of Abnormal Uterine Bleeding.,"Objectives


This study aimed to compare the diagnostic accuracy, inadequate sampling, pain during the procedure (Visual Analog Scale [VAS] score), and ease of insertion of the Karman's cannula and Pipelle biopsy for patients with abnormal uterine bleeding (AUB).
Methods


This prospective observational randomized comparative study included women of age more than 40 years with complaints of AUB. Two hundred and fifty women were randomly divided into two groups: (1) Group A ( n  = 125) who underwent endometrial aspiration using Karman's cannula and (2) Group B ( n  = 125) who underwent Pipelle endometrial sampling. Both the groups were followed by conventional dilation and curettage (D and C) which was considered the gold standard. Sensitivity, specificity, positive predictive value, and negative predictive value for differentiating benign and malignant conditions of endometrium were calculated.
Results


Group B had a sensitivity of 89.29% followed by Group A (86.36%); on the other hand, Group A had a specificity of 96.08% followed by Group B (95.74%) ( P  > 0.05). Inadequacy was comparable among the two groups with 1 inadequate in Group A and 3 inadequate in Group B. Mean VAS score was significantly lesser in Group A than Group B (4.5 ± 2 vs. 5.8 ± 2.1,  P  < 0.0001). Ease of insertion was similar in Groups A and B ( P  = 0.345).
Conclusion


Both procedures were equivalent in diagnostic accuracy, inadequacy, and ease of insertion. However, the use of Karman cannula resulted in less pain and is a much cheaper option in comparison to Pipelle. Overall, either procedure can be performed on an outpatient basis without cervical dilation and anesthesia and thus may be routinely used for women presenting with AUB.",2022,"Ease of insertion was similar in Groups A and B ( P  = 0.345).
","['patients with abnormal uterine bleeding (AUB', 'Two hundred and fifty women', 'women of age more than 40 years with complaints of AUB', 'women presenting with AUB']","[""endometrial aspiration using Karman's cannula and (2) Group B ( n  = 125) who underwent Pipelle endometrial sampling"", 'Karman cannula', ""Karman's Cannula and Pipelle Biopsy""]","['sensitivity', 'diagnostic accuracy, inadequacy, and ease of insertion', 'pain', 'Mean VAS score', ""diagnostic accuracy, inadequate sampling, pain during the procedure (Visual Analog Scale [VAS] score), and ease of insertion of the Karman's cannula and Pipelle biopsy"", 'Sensitivity, specificity, positive predictive value, and negative predictive value for differentiating benign and malignant conditions of endometrium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3697653', 'cui_str': 'Age more than 40 years'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0441192', 'cui_str': 'Pipelle'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0441192', 'cui_str': 'Pipelle'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}]",250.0,0.0122042,"Ease of insertion was similar in Groups A and B ( P  = 0.345).
","[{'ForeName': 'Meeta', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Obst and Gynae, ASCOMS, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Puneeta', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, ASCOMS, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Yadav', 'Affiliation': 'Department of Obst and Gynae, S.N. Medical College, Agra, Uttar Pradesh, India.'}]",Journal of mid-life health,['10.4103/jmh.jmh_292_20']
2034,35707307,Cardiovascular and Osteoporosis Protection at Menopause with Lycopene: A Placebo-Controlled Double-Blind Randomized Clinical Trial.,"Objective


The effect of lycopene (LycoRed) supplementation was evaluated in healthy postmenopausal women by biochemical markers for cardiovascular protection and osteoporosis protection.
Study Settings and Design


This was a multi-centric placebo-controlled double-blind randomized clinical trial that screened 198 postmenopausal women at 21 centers across 12 cities in India. Levels of lycopene, lipid profile, high-risk C-reactive protein, and bone turnover markers: amino-terminal propeptide of Type I collagen (P1NP) and C-terminal telopeptide of Type I collagen (β-CTx) were measured at baseline and 6 months postsupplementation with LycoRed or placebo.
Interventions


The study was completed with 57 of the 100 women on LycoRed 8 mg (antioxidant potency is equivalent to 24 mg of lycopene) and 43 placebos for 6 months by randomization.
Main Outcome Measures


Rise in serum lycopene and effect of serum lycopene on surrogate markers of cardiovascular health and bone health.
Results


LycoRed supplementation increases lycopene levels and P1NP and nonsignificant fall in β-CTx levels in healthy postmenopausal women.
Conclusions


Lycopene supplementation in Indian menopausal women may confer protection from osteoporosis as shown by the directional change in the surrogate biochemical markers. This study can form a basis for larger studies with different doses to understand the effect of lycopene to prevent and act as adjuvant treatment on clinical endpoints for cardiovascular disease (CVD) and bone health.",2022,"Results


LycoRed supplementation increases lycopene levels and P1NP and nonsignificant fall in β-CTx levels in healthy postmenopausal women.
","['Indian menopausal women', 'healthy postmenopausal women by biochemical markers for cardiovascular protection and osteoporosis protection', '198 postmenopausal women at 21 centers across 12 cities in India', '57 of the 100 women on', 'healthy postmenopausal women']","['lycopene (LycoRed) supplementation', 'Lycopene', 'LycoRed 8 mg (antioxidant potency is equivalent to 24 mg of lycopene', 'Lycopene supplementation', 'lycopene', 'LycoRed supplementation', 'placebo', 'Placebo']","['lycopene levels and P1NP', 'β-CTx levels', 'serum lycopene and effect of serum lycopene on surrogate markers of cardiovascular health and bone health', 'Levels of lycopene, lipid profile, high-risk C-reactive protein, and bone turnover markers: amino-terminal propeptide of Type I collagen (P1NP) and C-terminal telopeptide of Type I collagen (β-CTx']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086589', 'cui_str': 'Marker, Surrogate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1101784', 'cui_str': 'ICTP peptide'}]",198.0,0.478661,"Results


LycoRed supplementation increases lycopene levels and P1NP and nonsignificant fall in β-CTx levels in healthy postmenopausal women.
","[{'ForeName': 'Meeta', 'Initials': 'M', 'LastName': 'Meeta', 'Affiliation': 'Department of Gynaecologist, Tanvir Hospital, Hyderabad, Telangana, India.'}, {'ForeName': 'Sudhaa', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Gynaecologist, Jammu and Kashmir, India.'}, {'ForeName': 'Jyothi', 'Initials': 'J', 'LastName': 'Unni', 'Affiliation': 'Department of Gynaecologist, Jehangir Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Sunila', 'Initials': 'S', 'LastName': 'Khandelwal', 'Affiliation': 'Department of Gynaecologist, Mid-life Women Health Care and Menopause Centre, Fortis Escorts and Apex Hospital, Jaipur, Rajasthan, India.'}, {'ForeName': 'Ambuja', 'Initials': 'A', 'LastName': 'Choranur', 'Affiliation': 'Department of Gynaecologist, Osmania Medical College, Hyderabad, Telangana, India.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Malik', 'Affiliation': 'Fertility Specialist, Southend Fertility and IVF Centre, New Delhi, India.'}]",Journal of mid-life health,['10.4103/jmh.jmh_61_22']
2035,35707303,Improvement in Quality of Life of Postmenopausal Women with Depression with commonly used Antidepressants (Escitalopram vs. Desvenlafaxine): A Randomized Controlled Trial in a Tertiary Care Teaching Hospital of North India.,"Introduction


The postmenopausal symptoms affect the quality of life (QoL) of women. Depression and anxiety too have been associated with diminished QoL. It is known that antidepressants escitalopram and desvenlafaxine are effective in the treatment of depression and anxiety. However, to the best of our knowledge, their comparative effect on the QoL of postmenopausal women with depression and anxiety has not been studied in the Indian setup.
Materials and Methods


The present study was a randomized, intention to treat, open-label trial undertaken in North India's a tertiary care teaching hospital. Postmenopausal women attending the psychiatry outpatient department and newly diagnosed with depression and anxiety were randomized in two groups to receive Tab. Escitalopram 10-20 mg and Tab. Desvenlafaxine 50-100 mg. Their QoL was assessed using the WHOQOL BREF scale at baseline, 3 weeks and 6 weeks.
Results


Escitalopram was observed to be statistically better than desvenlafaxine in improving the overall QoL score of the WHOQOL-BREF scale. Individually, escitalopram significantly improved the scores of the physical health domain, psychological and environmental domains except for the social relationship domain. Desvenlafaxine significantly improved scores of all four domains.
Conclusion


Escitalopram was observed to be significantly better than desvenlafaxine in improving the overall QoL scores. Both the drugs were well tolerated.",2022,"Results


Escitalopram was observed to be statistically better than desvenlafaxine in improving the overall QoL score of the WHOQOL-BREF scale.","[""North India's a tertiary care teaching hospital"", 'Tertiary Care Teaching Hospital of North India', 'Postmenopausal Women with Depression with commonly used Antidepressants (Escitalopram vs', 'Postmenopausal women attending the psychiatry outpatient department and newly diagnosed with depression and anxiety']","['Escitalopram 10-20 mg and Tab', 'Desvenlafaxine', 'desvenlafaxine']","['Depression and anxiety', 'tolerated', 'Quality of Life', 'overall QoL scores', 'WHOQOL BREF scale', 'quality of life (QoL) of women', 'overall QoL score of the WHOQOL-BREF scale', 'scores of the physical health domain, psychological and environmental domains except for the social relationship domain']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1880288', 'cui_str': 'Desvenlafaxine'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0534006,"Results


Escitalopram was observed to be statistically better than desvenlafaxine in improving the overall QoL score of the WHOQOL-BREF scale.","[{'ForeName': 'Sonia Shinde', 'Initials': 'SS', 'LastName': 'Mahajan', 'Affiliation': 'Department of Pharmacology, Government Medical College, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Arora', 'Affiliation': 'Department of Psychiatry, Psychiatry Diseases Hospital, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Vishal R', 'Initials': 'VR', 'LastName': 'Tandon', 'Affiliation': 'Department of Pharmacology, Government Medical College, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Annil', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Department of Internal Medicine, Government Medical College, Jammu, Jammu and Kashmir, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Kotwal', 'Affiliation': 'Department of Internal Medicine, Government Medical College, Jammu, Jammu and Kashmir, India.'}]",Journal of mid-life health,['10.4103/jmh.jmh_150_21']
2036,35707300,Comparison of Effectiveness of Home-Based Verses Supervised Pelvic Floor Muscle Exercise in Women with Urinary Incontinence.,"Background


Urinary incontinence (UI) is a significant health problem with serious physical, psychological, and social consequences. Pelvic floor muscle exercise (PFME) is proven efficacious in the prevention and management of UI. A lack of trained physiotherapist in rural areas mars the uptake of physiotherapy and therefore innovative mechanisms are required. The present study was undertaken to evaluate the usefulness of home-based physiotherapy in the management of UI.
Materials and Methods


A total of 49 women, who screened positive for UI from a larger study conducted in 4 randomly selected villages of Charutar region, were included in the study. They were assigned home-based or supervised regimens randomly. All participants received education about UI and its management. A structured PFME schedule was developed. Participants in the supervised group received PFME by a trained physiotherapist, while those in the home-based group received training on exercise. Details of each session were documented through a daily diary in both groups. Revised urinary incontinence scale (RUIS) and incontinence impact questionnaire (IIQ-7) were administered at baseline and after 6 months to assess and compare the impact across groups.
Results


Analysis of variance (with  post hoc  comparisons) was employed to compare the effect of physiotherapy across groups. Only 18 (10 supervised and 8 home-based group) out of 49 women participated. Another 10 provided the required data, albeit had not done any exercises. The mean standard deviation of RUIS ( P  = 0.84) and IIQ-7 ( P  = 0.55) scores was similar at baseline across the groups. The RUIS ( P  = 0.01) and IIQ-7 ( P  = 0.006) improved significantly; however,  post hoc  analysis revealed that both RUIS and IIQ-7 improved significantly only in the supervised group.
Conclusion


Supervised exercise worked better, whereas home-based exercise failed to achieve the desired impact. Identifying barriers in home-based exercise and finding feasible solutions would prove a breakthrough in the management of UI in resource-limited settings.",2022,"The RUIS ( P  = 0.01) and IIQ-7 ( P  = 0.006) improved significantly; however,  post hoc  analysis revealed that both RUIS and IIQ-7 improved significantly only in the supervised group.
","['Women with Urinary Incontinence', '49 women participated', '49 women, who screened positive for UI from a larger study conducted in 4 randomly selected villages of Charutar region, were included in the study']","['Home-Based Verses Supervised Pelvic Floor Muscle Exercise', 'Pelvic floor muscle exercise (PFME', 'home-based physiotherapy', 'PFME by a trained physiotherapist, while those in the home-based group received training on exercise']","['mean standard deviation of RUIS', 'Revised urinary incontinence scale (RUIS) and incontinence impact questionnaire (IIQ-7', 'IIQ-7', 'RUIS and IIQ-7']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042553', 'cui_str': 'Versed'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",49.0,0.0182294,"The RUIS ( P  = 0.01) and IIQ-7 ( P  = 0.006) improved significantly; however,  post hoc  analysis revealed that both RUIS and IIQ-7 improved significantly only in the supervised group.
","[{'ForeName': 'Daxa G', 'Initials': 'DG', 'LastName': 'Mishra', 'Affiliation': ""Women's Health Unit, KM Patel Institute of Physiotherapy, Bhaikaka University, Anand, Gujarat, India.""}, {'ForeName': 'Smruti Bhalendu', 'Initials': 'SB', 'LastName': 'Vaishnav', 'Affiliation': 'Department of Obstetrics and Gynecology, Bhaikaka University, Anand, Gujarat, India.'}, {'ForeName': 'Ajay Gajanan', 'Initials': 'AG', 'LastName': 'Phatak', 'Affiliation': 'Central Research Services, Bhaikaka University, Anand, Gujarat, India.'}]",Journal of mid-life health,['10.4103/jmh.jmh_83_21']
2037,35707548,The Subjective and Objective Improvement of Non-Invasive Treatment of Schumann Resonance in Insomnia-A Randomized and Double-Blinded Study.,"Purpose


Accumulated studies revealed that electromagnetic field can affect human brain and sleep, and the extremely low-frequency electromagnetic field, Schumann resonance, may have the potential to reduce insomnia symptoms. The purpose of this study was to investigate the responses of patients with insomnia to a non-invasive treatment, Schumann resonance (SR), and to evaluate its effectiveness by subjective and objective sleep assessments.
Patients and Methods


We adopted a double-blinded and randomized design and 40 participants (70% female; 50.00 ± 13.38 year) with insomnia completed the entire study. These participants were divided into the SR-sleep-device group and the placebo-device group and were followed up for four weeks. The study used polysomnography (PSG) to measure objective sleep and used sleep diaries, Pittsburgh Sleep Quality Inventory (PSQI), Epworth Sleepiness Scale (ESS), and visual analogy of sleep satisfaction to measure subjective sleep. The 36-Item Short-Form Health Survey (SF-36) was used to evaluate quality of life. Chi-square test, Mann-Whitney  U -test, and Wilcoxon test were used to analyze the data.
Results


About 70% of the subjects were women, with an average age of 50±13.38 years and an average history of insomnia of 9.68±8.86 years. We found that in the SR-sleep-device group, objective sleep measurements (sleep-onset-latency, SOL, and total-sleep-time, TST) and subjective sleep questionnaires (SOL, TST, sleep-efficiency, sleep-quality, daytime-sleepiness, and sleep-satisfaction) were significantly improved after using the SR-sleep-device; in the placebo-device group, only such subjective sleep improvements as PSQI and sleep-satisfaction were observed.
Conclusion


This study demonstrates that the SR-sleep-device can reduce the insomnia symptoms through both objective and subjective tests, with minimal adverse effects. Future studies can explore the possible mechanism of SR and health effects and, with a longer tracking time, verify the effectiveness and side effects.",2022,"We found that in the SR-sleep-device group, objective sleep measurements (sleep-onset-latency, SOL, and total-sleep-time, TST) and subjective sleep questionnaires (SOL, TST, sleep-efficiency, sleep-quality, daytime-sleepiness, and sleep-satisfaction) were significantly improved after using the SR-sleep-device; in the placebo-device group, only such subjective sleep improvements as PSQI and sleep-satisfaction were observed.
","['patients with insomnia to a non-invasive treatment, Schumann resonance (SR', 'subjects were women, with an average age of 50±13.38 years and an average history of insomnia of 9.68±8.86 years', '40 participants (70% female; 50.00 ± 13.38 year) with insomnia completed the entire study']","['polysomnography (PSG', 'SR-sleep-device group and the placebo-device', 'Schumann Resonance']","['objective sleep and used sleep diaries, Pittsburgh Sleep Quality Inventory (PSQI), Epworth Sleepiness Scale (ESS), and visual analogy of sleep satisfaction to measure subjective sleep', 'quality of life', 'subjective sleep improvements as PSQI and sleep-satisfaction', 'objective sleep measurements (sleep-onset-latency, SOL, and total-sleep-time, TST) and subjective sleep questionnaires (SOL, TST, sleep-efficiency, sleep-quality, daytime-sleepiness, and sleep-satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}]",,0.0436376,"We found that in the SR-sleep-device group, objective sleep measurements (sleep-onset-latency, SOL, and total-sleep-time, TST) and subjective sleep questionnaires (SOL, TST, sleep-efficiency, sleep-quality, daytime-sleepiness, and sleep-satisfaction) were significantly improved after using the SR-sleep-device; in the placebo-device group, only such subjective sleep improvements as PSQI and sleep-satisfaction were observed.
","[{'ForeName': 'Yu-Shu', 'Initials': 'YS', 'LastName': 'Huang', 'Affiliation': 'Division of Pediatric Psychiatry and Sleep Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tang', 'Affiliation': 'Division of Pediatric Psychiatry and Sleep Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Wei-Chih', 'Initials': 'WC', 'LastName': 'Chin', 'Affiliation': 'Division of Pediatric Psychiatry and Sleep Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Ling-Sheng', 'Initials': 'LS', 'LastName': 'Jang', 'Affiliation': 'Department of Electrical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Chin-Pang', 'Initials': 'CP', 'LastName': 'Lee', 'Affiliation': 'Division of Pediatric Psychiatry and Sleep Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Biomedical Sciences and Engineering, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Chun-Pai', 'Initials': 'CP', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Kuang Tien General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Shu-Ling', 'Initials': 'SL', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Psychology, Fu Jen Catholic University, New Taipei City, Taiwan.'}]",Nature and science of sleep,['10.2147/NSS.S346941']
2038,35707522,"Efficacy of the Integrative Acupuncture and Moxibustion Treatment in Patients With Major Depressive Disorder: The Study Protocol for a Multicenter, Single-Blinded, Randomized Trial in China.","Introduction


Antidepressants are the front-line treatments for major depressive disorder (MDD), but remain unsatisfactory in outcome. An increasing number of patients are interested in acupuncture and moxibustion treatment as complementary therapies. This study aims to evaluate the efficacy and safety of integrative acupuncture and moxibustion (iAM) treatment in patients with MDD.
Methods and Analysis


This multicenter, single-blind, 2 × 2 factorial randomized trial will enroll 592 patients with MDD of moderate severity from nine hospitals. All patients will be randomized, in a ratio of 2:2:2:1, through a computerized central randomization system, into four groups (the combined, iAM-only, sertraline-only, and placebo groups). Participants will undergo a 12-week intervention with either 50 mg of sertraline or a placebo once a day and active/sham iAM treatment three times per week. The primary outcome is depression severity, assessed using the Hamilton Depression Scale-17. The secondary outcomes include self-rated depression severity, anxiety, and sleep quality. The primary and secondary outcomes will be measured at weeks 0, 4, 8, 12, and the 8th week posttreatment. Safety will be evaluated through liver and kidney function tests conducted before and after treatment and through monitoring of daily adverse events. An intent-to-treat principle will be followed for the outcome analyses.
Conclusion


This trial will provide sufficient evidence to ascertain whether iAM is effective and safe for treating MDD and provides a suitable combination strategy for treating MDD.
Clinical Trial Registration


[www.chictr.org.cn], identifier [ChiCTR2100042841].",2022,"The primary and secondary outcomes will be measured at weeks 0, 4, 8, 12, and the 8th week posttreatment.","['patients with MDD', '592 patients with MDD of moderate severity from nine hospitals', 'Patients With Major Depressive Disorder']","['integrative acupuncture and moxibustion (iAM', 'iAM-only, sertraline-only, and placebo', 'Integrative Acupuncture and Moxibustion Treatment', 'sertraline or a placebo']","['efficacy and safety', 'depression severity, assessed using the Hamilton Depression Scale-17', 'self-rated depression severity, anxiety, and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",592.0,0.246045,"The primary and secondary outcomes will be measured at weeks 0, 4, 8, 12, and the 8th week posttreatment.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Shenzhen Bao'an Traditional Chinese Medicine Hospital, Guangzhou University of Chinese Medicine, Shenzhen, China.""}, {'ForeName': 'Baile', 'Initials': 'B', 'LastName': 'Ning', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Luda', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': ""Shenzhen Bao'an Traditional Chinese Medicine Hospital, Guangzhou University of Chinese Medicine, Shenzhen, China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Shenzhen Bao'an Traditional Chinese Medicine Hospital, Guangzhou University of Chinese Medicine, Shenzhen, China.""}, {'ForeName': 'Delong', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'School of Psychology, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'College of Teacher Education, Guangdong University of Education, Guangzhou, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Key Unit of Methodology in Clinical Research, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shengyong', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'The First Affiliated Hospital of Guangxi Chinese Medical University, Nanning, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Guangcai', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Hainan Provincial Hospital of Chinese Medicine, Haikou, China.'}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'The First Affiliated Hospital of Tianjin Chinese Medical University, Tianjin, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'The Second Affiliated Hospital of Anhui Chinese Medical University, Hefei, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Sleep Medical Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'Brain Hospital Affiliated Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Psychosomatic Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Frontiers in medicine,['10.3389/fmed.2022.761419']
2039,35707484,Comparative Study on the effectiveness of Glycopyrrolate/Formoterol versus Tiotropium/Formoterol in patients with Chronic Obstructive Pulmonary Disease.,"Background


Chronic Obstructive Pulmonary Disease (COPD) has several implications on health, lifestyle, and economic burden. Combinational therapy using muscarinic antagonists and beta- 2  agonists has long been warranted for use as maintenance therapy. A lack of studies directly comparing Glycopyrrolate/Formoterol (GFF) versus Tiotropium/Formoterol (TFF) was observed which led us to analyze the effectiveness of these combinations.
Methods


In this pilot, prospective, randomized, open-label, parallel-arm, 12-week period study, 60 patients with COPD (moderate-severe) were randomized in a 1:1 ratio to receive either GFF or TFF (n = 30 each). The primary outcome was to demonstrate non-inferiority between the two groups concerning FEV 1  for 12 weeks. The secondary outcome was the assessment of the ratio of FEV 1 /FVC and state of health evaluation by St. George's Respiratory Questionnaire (SGRQ).
Results


Out of 60 participants, 58 subjects completed the study. At week 12, the mean and standard deviation value of FEV 1  between groups were 1.49 ± 0.38 and 1.38 ± 0.30 (p > 0.05) and FEV 1 /FVC ratio were 0.67 ± 0.09 and 0.74 ± 0.08 (p < 0.01) respectively. A significant difference was observed in the FEV 1  and FEV 1 /FVC values in comparison with baseline versus last follow up in both the groups (p < 0.01). However, no remarkable variation was identified in the FEV 1  values over the two groups. The health status assessment by SGRQ showed significant improvement in both groups after the treatment.
Conclusion


Non-inferiority of GFF when compared to TFF was established along with good tolerability and comparable adverse effect profile.",2022,A significant difference was observed in the FEV 1  and FEV 1 /FVC values in comparison with baseline versus last follow up in both the groups (p < 0.01).,"['60 participants', '58 subjects completed the study', 'patients with Chronic Obstructive Pulmonary Disease', '60 patients with COPD (moderate-severe', '\n\n\nChronic Obstructive Pulmonary Disease (COPD']","['Glycopyrrolate/Formoterol (GFF', 'TFF', 'Tiotropium/Formoterol (TFF', 'Tiotropium/Formoterol', 'GFF or TFF', 'Glycopyrrolate/Formoterol']","['non-inferiority', 'FEV 1 /FVC ratio', ""ratio of FEV 1 /FVC and state of health evaluation by St. George's Respiratory Questionnaire (SGRQ"", 'FEV 1  and FEV 1 /FVC values']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0077375', 'cui_str': 'trofosfamide'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.043051,A significant difference was observed in the FEV 1  and FEV 1 /FVC values in comparison with baseline versus last follow up in both the groups (p < 0.01).,"[{'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Jayanthi', 'Affiliation': 'Department of Respiratory Medicine, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, 603203, India.'}, {'ForeName': 'Karthickeyan', 'Initials': 'K', 'LastName': 'Krishnan', 'Affiliation': 'Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, 603203, India.'}, {'ForeName': 'Manali', 'Initials': 'M', 'LastName': 'Sudhir', 'Affiliation': 'Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, 603203, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Girija', 'Affiliation': 'Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, 603203, India.'}, {'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'P A', 'Affiliation': 'Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, 603203, India.'}, {'ForeName': 'Sathish', 'Initials': 'S', 'LastName': 'Kumar J', 'Affiliation': 'Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, 603203, India.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2022.100931']
2040,35707482,Intensive Health Care plus Vitamin D Administration Benefits the Growth and Development of Young Children and Reduces the Incidence of Nutritional Disorders.,"This study was intended to assess the effect of intensive health care plus vitamin D administration on the growth, development, and nutritional status of young children. Totally, 131 young children who were admitted to Shiyan Maternal and Child Health Care Hospital from January 2020 to January 2021 were included and assigned via the random number table method at a ratio of 1 : 1 : 1 to receive either vitamin D administration (vitamin D group,  n  = 42), intensive health care (IHC) (IHC group,  n  = 44), or vitamin D administration plus intensive health care (combination group,  n  = 45). All children received a normal diet and routine care. After the intervention, all children showed robust improvement in their height, weight, neuropsychological development, and nutritional status, in which the combination therapy was associated with better outcomes in terms of physical development, neuropsychological development, and nutritional status, and a higher serum 25-hydroxyvitamin D3 (25-(OH)D3) level of the children versus monotherapy. Children receiving combined therapy had a significantly lower incidence of nutritional disorders than those receiving single therapy. Intensive health care plus vitamin D benefits the growth and development of young children and reduces the incidence of nutritional disorders in children.",2022,Intensive health care plus vitamin D benefits the growth and development of young children and reduces the incidence of nutritional disorders in children.,"['children', '131 young children who were admitted to Shiyan Maternal and Child Health Care Hospital from January 2020 to January 2021 were included and assigned via the random number table method at a ratio of 1\u2009:\u20091\u2009:\u20091 to receive either', 'young children']","['Intensive health care plus vitamin D', 'intensive health care plus vitamin D', 'normal diet and routine care', 'vitamin D administration (vitamin D group,  n \u2009=\u200942), intensive health care (IHC) (IHC group,  n \u2009=\u200944), or vitamin D administration plus intensive health care (combination group,  n \u2009=\u200945']","['nutritional disorders', 'physical development, neuropsychological development, and nutritional status, and a higher serum 25-hydroxyvitamin D3 (25-(OH)D3) level', 'Incidence of Nutritional Disorders', 'height, weight, neuropsychological development, and nutritional status']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]","[{'cui': 'C3714509', 'cui_str': 'Nutritional disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",131.0,0.0821811,Intensive health care plus vitamin D benefits the growth and development of young children and reduces the incidence of nutritional disorders in children.,"[{'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Children Rehabilitation Department of Shiyan Maternal and Child Health Care Hospital, Shiyan, Hubei Province, China.'}, {'ForeName': 'Qingwen', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'Children Healthcare Center of Shiyan Maternal and Child Health Care Hospital, Shiyan, Hubei Province, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/8097035']
2041,35707478,Effect of Acupressure on Health-Related Quality of Life in Patients with Polycystic Ovarian Syndrome: A Randomized Clinical Trial.,"The present study was conducted to determine the effect of acupressure on health-related quality of life in patients with polycystic ovary syndrome. This study was a double-blind, randomized clinical trial with a control group. Ninety-six patients with polycystic ovary syndrome from Mofateh gynecological clinic in Yasuj in Iran were enrolled according to the inclusion criteria. Patients were randomly assigned to intervention and control groups. In the intervention group, pressure on the points, Ren3, Ren4, Liv3, Sp6, and Sp10 and in the control group, pressure on sham points were performed for 6 weeks (2 sessions per week). The primary outcome was health-related quality of life, measured by the modified polycystic ovary syndrome health-related quality of life questionnaire (MPCOSQ). The secondary outcomes were total testosterone levels and clinical symptoms in patients with polycystic ovary syndrome. The outcome variables were measured before the intervention at week 0 (baseline) and after the intervention at week 18 (12 weeks after the end of intervention). The results indicated that at week 18, the score of clinical symptoms and the total testosterone level of the intervention group were lower than those of the control group. The health-related quality of life score in the intervention group was higher than that in the control group, which was statistically significant ( P  < 0/05). Therefore, acupressure in these points is recommended as a practical and effective method of treating polycystic ovarian syndrome.",2022,"The health-related quality of life score in the intervention group was higher than that in the control group, which was statistically significant ( P  < 0/05).","['Patients with Polycystic Ovarian Syndrome', 'patients with polycystic ovary syndrome', 'Ninety-six patients with polycystic ovary syndrome from Mofateh gynecological clinic in Yasuj in Iran were enrolled according to the inclusion criteria']","['acupressure', 'Acupressure']","['health-related quality of life', 'health-related quality of life score', 'Health-Related Quality of Life', 'health-related quality of life, measured by the modified polycystic ovary syndrome health-related quality of life questionnaire (MPCOSQ', 'total testosterone levels and clinical symptoms', 'score of clinical symptoms and the total testosterone level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",96.0,0.104292,"The health-related quality of life score in the intervention group was higher than that in the control group, which was statistically significant ( P  < 0/05).","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Nekooi', 'Affiliation': 'Student Research Committee, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bazarganipour', 'Affiliation': 'Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Zoladl', 'Affiliation': 'Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Heshmat', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahintaj', 'Initials': 'S', 'LastName': 'Aramesh', 'Affiliation': 'Department of Gynecology and Obstetrics, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Nazafarin', 'Initials': 'N', 'LastName': 'Hosseini', 'Affiliation': 'Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/2920132']
2042,35707469,Ultrasound Multiparametric Assessment of the Impact of Hypertensive Disorders of Pregnancy on Fetal Cardiac Function and Growth and Development.,"Objective


To evaluate the ultrasound multiparametric assessment of the impact of hypertensive disorders of pregnancy (HDP) on fetal cardiac function and growth and development.
Methods


In this prospective study, 98 cases of HDP treated in our institution were recruited into a study group, and 100 pregnant women with healthy singleton pregnancies were included in a control group. All eligible patients were also assigned to either study group A (HDP fetuses with growth restriction) or study group B (HDP fetuses with normal growth). Fetal echocardiography was performed on all eligible participants to obtain hemodynamic and cardiac function parameters for the evaluation of fetal growth and development, and the impact of HDP on fetal heart function and growth and development was analyzed.
Results


HDP fetuses were associated with smaller head circumference, biparietal diameter, femoral length, and abdominal circumference versus healthy fetuses. The study group had a higher resistance index (RI) and pulsatility index (PI) of umbilical artery (UA), ductus venous (DV), pulmonary vein (PV), and lower RI and PI of aortic isthmus (AoI) than the control group. The study group showed higher left and right ventricular isovolumic contraction time (IVCT), isovolumic relaxation time (IVRT), and myocardial performance index (MPI) values and lower mitral and tricuspid  E  wave and  E / A  values than the control group. The systolic blood pressure was positively correlated with PI, RI of UA, DV, and PV, and left and right ventricular IVCT, IVRT, and MPI and negatively correlated with PI and RI of AoI and mitral and tricuspid  E  wave and  E / A  values of HDP fetuses. The peak systolic/diastolic flow rate (S/D), PI, and RI of umbilical blood flow in study group A were higher than those in study group B. Umbilical blood flow  S / D  showed the highest AUC and specificity for predicting fetal growth restriction, and PI had the highest sensitivity for predicting fetal growth restriction.
Conclusion


HDP compromises fetal cardiac function and growth, and ultrasound multiparametric assessment provides accurate detection of fetal cardiac function and hemodynamics changes. The patient's condition can be monitored through the assessment of ultrasound parameters of fetal growth and development.",2022,"Results


HDP fetuses were associated with smaller head circumference, biparietal diameter, femoral length, and abdominal circumference versus healthy fetuses.","['98 cases of HDP treated in our institution were recruited into a study group, and 100 pregnant women with healthy singleton pregnancies', 'All eligible patients were also assigned to either study group A (HDP fetuses with growth restriction) or study group B (HDP fetuses with normal growth']","['Fetal echocardiography', 'pregnancy (HDP', 'ultrasound multiparametric assessment']","['PI, RI of UA, DV, and PV, and left and right ventricular IVCT, IVRT, and MPI and negatively correlated with PI and RI of AoI and mitral and tricuspid  E  wave and', 'fetal cardiac function and growth and development', 'smaller head circumference, biparietal diameter, femoral length, and abdominal circumference', 'higher left and right ventricular isovolumic contraction time (IVCT), isovolumic relaxation time (IVRT), and myocardial performance index (MPI) values and lower mitral and tricuspid  E  wave and  E / A  values', 'higher resistance index (RI) and pulsatility index (PI) of umbilical artery (UA), ductus venous (DV), pulmonary vein (PV), and lower RI and PI of aortic isthmus (AoI', 'systolic blood pressure', 'peak systolic/diastolic flow rate (S/D), PI, and RI of umbilical blood flow']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0412564', 'cui_str': 'Fetal echocardiography'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C2733285', 'cui_str': 'Right ventricular isovolumic contraction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0226019', 'cui_str': 'Structure of aortic isthmus'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0424688', 'cui_str': 'Small head'}, {'cui': 'C0552399', 'cui_str': 'Biparietal diameter'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",100.0,0.0192235,"Results


HDP fetuses were associated with smaller head circumference, biparietal diameter, femoral length, and abdominal circumference versus healthy fetuses.","[{'ForeName': 'Maoting', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Second Department of Ultrasound Diagnosis, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Delivery Room, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Yongzhen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Second Department of Neurosurgery, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Second Department of Ultrasound Diagnosis, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Second Department of Neurosurgery, Cangzhou Central Hospital, Cangzhou, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/3419966']
2043,35707866,The effectiveness of tomato extract on superoxide dismutase (SOD) and severity degree of patients with melasma.,"BACKGROUND


Melasma is present in 40% of cases in Southeast Asia. The condition is often unresponsive to therapy; treatment has variable success rates, and melasma has high recurrence rates. Lycopene-rich tomato extract is needed to avoid oxidative stress due to ultraviolet rays that cause melasma through the melanogenesis pathway. The aim of this study was to evaluate the effectiveness of an oral tomato extract supplement as an adjuvant for melasma therapy.
METHODS


The study recruited 62 subjects with melasma to a true-experimental clinic with a double-blind, randomized, pre and post-test control design over 12 weeks at the Diponegoro National Hospital, Indonesia. The subjects received an oral tomato extract supplement contains lycopene 30 mg (placebo). All subjects applied topical sunscreen and hydroquinone-4%-cream. Subjects were assessed by superoxide dismutase (SOD) and melasma area and severity index (MASI).
RESULTS


Fifty-nine patients completed the research. The serum SOD levels in the treatment group (tomato extract supplementation) were higher than in the control group given the placebo, with delta SOD (P<0.05). The difference in MASI Scores after therapy in the treatment group had a significant decrease compared to the control group, with statistical review results suggesting that the difference was significant (P<0.05).
CONCLUSIONS


Supplementation of tomato extract as an adjuvant therapy can increase serum SOD levels and improve melasma severity.",2022,"The serum SOD levels in the treatment group (tomato extract supplementation) were higher than in the control group given the placebo, with delta SOD (P<0.05).","['40% of cases in Southeast Asia', '62 subjects with melasma to a true-experimental clinic with a double-blind', 'Fifty-nine patients completed the research', 'patients with melasma']","['oral tomato extract supplement', 'placebo', 'tomato extract', 'oral tomato extract supplement contains lycopene 30 mg (placebo', 'topical sunscreen and hydroquinone-4%-cream', 'Lycopene-rich tomato extract']","['superoxide dismutase (SOD) and severity degree', 'MASI Scores', 'superoxide dismutase (SOD) and melasma area and severity index (MASI', 'serum SOD levels']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242772', 'cui_str': 'Tomato'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0689149', 'cui_str': 'Hydroquinone 40 mg/g cutaneous cream'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",62.0,0.0587145,"The serum SOD levels in the treatment group (tomato extract supplementation) were higher than in the control group given the placebo, with delta SOD (P<0.05).","[{'ForeName': 'Hayra D', 'Initials': 'HD', 'LastName': 'Avianggi', 'Affiliation': 'Department of Dermatovenereology, Faculty of Medicine, Diponegoro University, Semarang, Indonesia - hayra.dvjul17@gmail.com.'}, {'ForeName': 'Retno', 'Initials': 'R', 'LastName': 'Indar', 'Affiliation': 'Department of Dermatovenereology, Faculty of Medicine, Diponegoro University, Semarang, Indonesia.'}, {'ForeName': 'Diah', 'Initials': 'D', 'LastName': 'Adriani', 'Affiliation': 'Department of Dermatovenereology, Faculty of Medicine, Diponegoro University, Semarang, Indonesia.'}, {'ForeName': 'Puguh', 'Initials': 'P', 'LastName': 'Riyanto', 'Affiliation': 'Department of Dermatovenereology, Faculty of Medicine, Diponegoro University, Semarang, Indonesia.'}, {'ForeName': 'Muslimin', 'Initials': 'M', 'LastName': 'Muslimin', 'Affiliation': 'Department of Dermatovenereology, Faculty of Medicine, Diponegoro University, Semarang, Indonesia.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Afriliana', 'Affiliation': 'Department of Dermatovenereology, Faculty of Medicine, Diponegoro University, Semarang, Indonesia.'}, {'ForeName': 'Kabulrachman', 'Initials': 'K', 'LastName': 'Kabulrachman', 'Affiliation': 'Department of Dermatovenereology, Faculty of Medicine, Diponegoro University, Semarang, Indonesia.'}]",Italian journal of dermatology and venereology,['10.23736/S2784-8671.22.07152-3']
2044,35708162,Targeting the link between social media and eating disorder risk: A randomized controlled pilot study.,"OBJECTIVE


Evaluate the feasibility, acceptability, and preliminary efficacy of a self-criticism intervention addressing the link between appearance-motivated social media use and eating disorder risk. Another condition, designed to help users curate their social media feed to reduce negative impacts on wellbeing, was also trialed as an active and credible comparison.
METHOD


University students aged 17-25 (N = 170) were screened and randomized (n = 130) to the self-criticism intervention, social media curation, or waitlist control group. The intervention comprised self-guided cognitive behavior therapy delivered in four modules over 1 week. Primary outcomes were feasibility and acceptability. Secondary outcomes were appearance motivations for social media use, appearance comparison, self-criticism, body image flexibility, and disordered eating (at baseline, one-week postrandomization, and two-weeks postrandomization).
TRIAL REGISTRATION


ACTRN12621000353897.
RESULTS


Participants completed an average of 82% of the intervention modules and 77% of the homework exercises within the week allocated. The intervention was well-accepted; participants reported a range of positive aspects, alongside suggested modifications to the intervention and study design to improve acceptability. Group by time interactions suggested groups changed at a different rate on three secondary outcomes; between-groups effect sizes suggested this was due to greater improvements in the self-criticism group than waitlist control.
DISCUSSION


This was the first study to evaluate an intervention for the link between appearance-related social media use and eating disorder risk for young adults. Positive findings relating to feasibility, acceptability, and preliminary efficacy suggest a larger randomized controlled trial, with modifications to the intervention and study design, is warranted.
PUBLIC SIGNIFICANCE


Appearance-related social media use has been linked to poorer body image and disordered eating, necessitating treatments that can disrupt this relationship. The self-criticism intervention evaluated in this study shows promise as a strategy to address this need. It is the first intervention focused on appearance-related social media use to be designed for and tested in young adults, who are at heightened risk of developing an eating disorder.",2022,This was the first study to evaluate an intervention for the link between appearance-related social media use and eating disorder risk for young adults.,"['University students aged 17-25 (N\xa0=\xa0170', 'young adults, who are at heightened risk of developing an eating disorder', 'young adults']","['self-criticism intervention, social media curation, or waitlist control group', 'self-guided cognitive behavior therapy', 'self-criticism intervention']","['feasibility and acceptability', 'social media and eating disorder risk', 'appearance motivations for social media use, appearance comparison, self-criticism, body image flexibility, and disordered eating']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}]","[{'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}]",170.0,0.0155918,This was the first study to evaluate an intervention for the link between appearance-related social media use and eating disorder risk for young adults.,"[{'ForeName': 'Madelaine K', 'Initials': 'MK', 'LastName': 'de Valle', 'Affiliation': 'Discipline of Psychology, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Tracey D', 'Initials': 'TD', 'LastName': 'Wade', 'Affiliation': 'Discipline of Psychology, Flinders University, Adelaide, South Australia, Australia.'}]",The International journal of eating disorders,['10.1002/eat.23756']
2045,35708140,"Effect of melatonin intake on postural balance, functional mobility and fall risk in persons with multiple sclerosis: a pilot study.","Aim:  To assess the safety and the effect of a nocturnal melatonin (MEL) ingestion on postural balance, functional mobility and fall risk, the following morning in adults with multiple sclerosis (MS). Methods:  Fourteen adults with relapsing-remitting MS (RR-MS) (28.36 ± 6.81 years) were evaluated before and after nocturnal ingestion of MEL (6 mg) or placebo (PLA). Evaluations included a posturographic test of static bipedal postural balance with dual-task in eyes open (EO) and eyes closed conditions, and a clinical test of unipedal balance. The physical performance tests were: Timed Up and Go test (TUGT) (mobility), Four Square Step Test (FSST), and Timed 25-foot walk test (T25FWT) (walking speed). Cognitive performance (Montreal Cognitive Assessment (MoCA) and Simple Reaction Time (SRT) tests) and sleep quality (Spiegel's sleep questionnaire (SSQ)] were also assessed. Results : In EO condition, MEL decreased the posturographic parameters [center of pressure (CoP) sway area (CoPAr), CoP path length (CoPL) and CoPL in mediolateral axis (CoPLX)] more than PLA by 12.48% ( p  = 0.0004), 14.25% ( p  = 0.04) and 15.82% ( p  = 0.0006), respectively. Durations of TUGT and FSST decreased following MEL session more than the PLA one by 14.52% ( p  = 0.01) and 19.85% ( p  = 0.0006), respectively. MEL increased the unipedal stance time, SSQ and MoCA scores more than PLA by 49.81% ( p  = 0.04), 32.21% ( p  = 0.004) and 11.87% ( p  = 0.008), respectively. Conclusion : This pilot study showed that acute nocturnal MEL ingestion seems to be safe for enhancing postural balance, functional mobility and fall risk in RR-MS adults probably through improving sleep quality and cognitive function. Clinical trial registration:  This study was retrospectively registered at the Pan African Clinical Trial Registry database on 20 June 2020 (PACTR202007922243550).",2022,"MEL increased the unipedal stance time, SSQ and MoCA scores more than PLA by 49.81% ( p  = 0.04), 32.21% ( p  = 0.004) and 11.87% ( p  = 0.008), respectively.","['Fourteen adults with relapsing-remitting MS (RR-MS) (28.36\u2009±\u20096.81\u2009years', 'persons with multiple sclerosis', 'adults with multiple sclerosis (MS']","['posturographic test of static bipedal postural balance with dual-task in eyes open (EO', 'MEL', 'MEL (6\u2009mg) or placebo (PLA', 'melatonin intake', 'nocturnal melatonin (MEL) ingestion']","['Durations of TUGT and FSST', 'posturographic parameters [center of pressure (CoP) sway area (CoPAr), CoP path length (CoPL) and CoPL in mediolateral axis (CoPLX', ""Cognitive performance (Montreal Cognitive Assessment (MoCA) and Simple Reaction Time (SRT) tests) and sleep quality (Spiegel's sleep questionnaire (SSQ"", 'Timed Up and Go test (TUGT) (mobility), Four Square Step Test (FSST), and Timed 25-foot walk test (T25FWT) (walking speed', 'postural balance, functional mobility and fall risk', 'unipedal stance time, SSQ and MoCA scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0939937', 'cui_str': 'Honey preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}]",14.0,0.0266875,"MEL increased the unipedal stance time, SSQ and MoCA scores more than PLA by 49.81% ( p  = 0.04), 32.21% ( p  = 0.004) and 11.87% ( p  = 0.008), respectively.","[{'ForeName': 'Sonda', 'Initials': 'S', 'LastName': 'Jallouli', 'Affiliation': 'Research laboratory of evaluation and management of musculoskeletal system pathologies, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Ghroubi', 'Affiliation': 'Research laboratory of evaluation and management of musculoskeletal system pathologies, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Ben Dhia', 'Affiliation': 'Research laboratory of evaluation and management of musculoskeletal system pathologies, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Abdelmoneem', 'Initials': 'A', 'LastName': 'Yahia', 'Affiliation': 'Research laboratory of evaluation and management of musculoskeletal system pathologies, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed Habib', 'Initials': 'MH', 'LastName': 'Elleuch', 'Affiliation': 'Research laboratory of evaluation and management of musculoskeletal system pathologies, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Sakka', 'Affiliation': ""Laboratory of Neurogenetics, Parkinson's Disease and Cerebrovascular Disease (LR12SP19), Habib Bourguiba University Hospital, University of Sfax, Sfax, Tunisia.""}, {'ForeName': 'Chokri', 'Initials': 'C', 'LastName': 'Mhiri', 'Affiliation': ""Laboratory of Neurogenetics, Parkinson's Disease and Cerebrovascular Disease (LR12SP19), Habib Bourguiba University Hospital, University of Sfax, Sfax, Tunisia.""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical Activity, Health and Learning (LINP2), Paris Nanterre University, Nanterre, France.'}]",The International journal of neuroscience,['10.1080/00207454.2022.2090353']
2046,35708131,Targeting cognitive control to reduce anxiety in very young children: A proof of concept study.,"OBJECTIVE


Underdeveloped cognitive control (CC)-the capacity to flexibly adjust to changing environments-may predispose some children to early onset anxiety disorders and represents a promising intervention target. The current study established and pilot-tested ""Camp Kidpower""-a novel group-based, interactive CC training intervention-and assessed its impacts on behavioral and neurophysiological indices of CC among preschool children with elevated anxiety symptoms.
METHODS


Forty-four anxious children (4-6 years) were enrolled in Camp Kidpower, delivered in four sessions over 10 days. Before and after camp, children's capacity for CC was measured using well-validated, non-trained behavioral tasks and error-related negativity (ERN). Child anxiety symptoms were measured by parent report on the Spence Preschool Anxiety Scale.
RESULTS


Thirty-two children completed the study, as defined by completion of pre- and follow-up assessments and at least three camp sessions. From baseline to after camp, performance on behavioral tests of CC improved, ERN amplitude increased, and anxiety symptoms decreased.
CONCLUSION


Results provide initial evidence that play-based cognitive training targeted to behavioral and brain markers of CC reduces anxiety in preschoolers.",2022,"The current study established and pilot-tested ""Camp Kidpower""-a novel group-based, interactive CC training intervention-and assessed its impacts on behavioral and neurophysiological indices of CC among preschool children with elevated anxiety symptoms.
","['preschoolers', 'Forty-four anxious children (4-6 years', 'very young children', 'preschool children with elevated anxiety symptoms']",[],"['Spence Preschool Anxiety Scale', 'ERN amplitude increased, and anxiety symptoms', 'Child anxiety symptoms']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",44.0,0.0288551,"The current study established and pilot-tested ""Camp Kidpower""-a novel group-based, interactive CC training intervention-and assessed its impacts on behavioral and neurophysiological indices of CC among preschool children with elevated anxiety symptoms.
","[{'ForeName': 'Hans S', 'Initials': 'HS', 'LastName': 'Schroder', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ka I', 'Initials': 'KI', 'LastName': 'Ip', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hruschak', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Horbatch', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Department of Psychology, University of Notre Dame, Notre Dame, Indiana, USA.'}, {'ForeName': 'Yanni', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mannella', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Muzik', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Rosenblum', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Moser', 'Affiliation': 'Department of Psychology, Michigan State University, E. Lansing, Michigan, USA.'}, {'ForeName': 'Kate D', 'Initials': 'KD', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",Depression and anxiety,['10.1002/da.23270']
2047,35708109,The effect of a restricted diet on the results of fractional microneedle radiofrequency therapy: A comparison of vegan and omnivorous participants in terms of the antiaging effect of radiofrequency therapy.,"OBJECTIVES


The aim of the present study was to compare the results of fractional microneedle radiofrequency (FMR) therapy in vegan and omnivorous participants.
METHODS


A total of 30 vegan and 30 omnivorous women who were treated with FMR therapy for combating aging were included in the study. The clinical results were examined in Months 3 and 6 based on the Fitzpatrick Wrinkle Scale (FWS). Individual satisfaction was investigated in Month 6 using the Patient's Global Impression of Change (PGIC).
RESULTS


At the onset of the treatment, there was no significant difference with regard to the FWS scores in both groups. The decrease in the FWS score was significantly lower in vegans after 3 months (p = 0.01). Vegans had worsened clinical outcomes by Month 6 (p = 0.01). The PGIC scores were significantly lower in vegans (p = 0.01).
CONCLUSION


A vegan diet adversely affects the outcome of FMR therapy.",2022,The decrease in the FWS score was significantly lower in vegans after 3 months (p = 0.01).,"['vegan and omnivorous participants', 'A total of 30 vegan and 30 omnivorous women who were treated with FMR therapy for combating aging were included in the study']","['radiofrequency therapy', 'fractional microneedle radiofrequency therapy', 'fractional microneedle radiofrequency (FMR) therapy']","['Individual satisfaction', 'FWS scores', 'FWS score', 'Fitzpatrick Wrinkle Scale (FWS', 'PGIC scores']","[{'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4704842', 'cui_str': 'Radio-Frequency Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4704842', 'cui_str': 'Radio-Frequency Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.0252399,The decrease in the FWS score was significantly lower in vegans after 3 months (p = 0.01).,"[{'ForeName': 'Nebahat Demet', 'Initials': 'ND', 'LastName': 'Akpolat', 'Affiliation': 'Halic University Faculty of Medicine, Department of dermatology, İstanbul, Turkey.'}, {'ForeName': 'Sezin', 'Initials': 'S', 'LastName': 'Unlu', 'Affiliation': 'Konya City Hospital, Konya, Turkey.'}]",Lasers in surgery and medicine,['10.1002/lsm.23577']
2048,35708106,Optimal Timing of Thyroid Hormone Replacement during Ramadan Fasting: A Randomized Controlled Trial in Patients with Prior Total Thyroidectomy.,"Background Fasting during Ramadan may be challenging for patients on levothyroxine(LT4), as the drug has a narrow therapeutic index and is administered on an empty stomach. The majority of Muslims who fast in Ramadan have two meals per day, iftar immediately after sunset and suhoor just before dawn. This study aimed to evaluate the impact of LT4 timing during Ramadan on thyroid-stimulating hormone(TSH) levels in patients who underwent total thyroidectomy to determine the best timing for intake and identify the predictors of TSH level changes. Methods We conducted a parallel, double-blind, randomized controlled trial on Saudi patients diagnosed with hypothyroidism who underwent total thyroidectomy. Patients were required to have stable thyroid function for six months prior to the study period and fast ≥ 20 days of Ramadan. Participants were randomized to one of three times for LT4 administration: Group A, 30 minutes pre-iftar(n=48); Group B, 3 hours post-iftar(n= 47); or Group C, 1 hour pre-suhoor(n=47). The number of participants in the final analysis (excluding patients who dropped out) was as follows:Group A,(n=31);Group B,(n= 34); and Group C,(n=22). The changes in TSH and free T4 levels two weeks before and after Ramadan were compared. Factors associated with a change in TSH levels were examined through multivariable analysis. Results TSH levels significantly increased in Group B(1.7±1.8 vs. 3.1±3.9 mU/L, p=0.003) and Group C(2±1.7 vs. 5.5±10 mU/L, p=0.011), but not Group A(1.8±1.6 vs. 3.3±4.2 mU/L,p=0.158). The change in free T4 levels was comparable among the groups: Group A, 16.5±2.7 vs. 15.9±3.2 mcg/dL, p=0.144; Group B, 15.8±3.8 vs. 16.3±3.6 mcg/dL, p=0.620; and Group C, 17.5±2.8 vs. 17.3±3.9 mcg/dL, p=0.770. In multivariable linear regression analysis, the following variables were significantly independently associated with TSH level change: age, weight gain, and the number of nonadherence days to LT4 where β=-0.2, p=0.026; β=+0.2, p=0.026; and β=+0.5, p<0.0001, respectively. Conclusions Fasting patients who took LT4 pre-iftar did not experience significant changes in TSH, whereas those who took LT4 post-iftar or pre-suhoor did. TSH changes during Ramadan may be associated with age(inverse association), weight gain, and the number of non-adherence to LT4 days. Trial registration SCTR Application no. 2112.",2022,"The change in free T4 levels was comparable among the groups: Group A, 16.5±2.7 vs. 15.9±3.2 mcg/dL, p=0.144; Group B, 15.8±3.8 vs. 16.3±3.6 mcg/dL, p=0.620; and Group C, 17.5±2.8 vs. 17.3±3.9 mcg/dL, p=0.770.","['Ramadan Fasting', 'Patients with Prior Total Thyroidectomy', 'patients who underwent total thyroidectomy', 'Saudi patients diagnosed with hypothyroidism who underwent total thyroidectomy']",['Thyroid Hormone Replacement'],"['TSH level change: age, weight gain', 'TSH levels', 'changes in TSH and free T4 levels', 'free T4 levels', 'stable thyroid function', 'TSH', 'Results TSH levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}]","[{'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.169385,"The change in free T4 levels was comparable among the groups: Group A, 16.5±2.7 vs. 15.9±3.2 mcg/dL, p=0.144; Group B, 15.8±3.8 vs. 16.3±3.6 mcg/dL, p=0.620; and Group C, 17.5±2.8 vs. 17.3±3.9 mcg/dL, p=0.770.","[{'ForeName': 'Khalid M', 'Initials': 'KM', 'LastName': 'Al-Qahtani', 'Affiliation': 'King Saud University, 37850, College of Medicine, Riyadh, Riyadh Province, Saudi Arabia; K.qahtaniMD@gmail.com.'}, {'ForeName': 'Ibraheem Ahmed', 'Initials': 'IA', 'LastName': 'Aldeeri', 'Affiliation': 'King Saud University, 37850, College of Medicine, Riyadh, Riyadh Province, Saudi Arabia; ibraheemaldeeri@gmail.com.'}, {'ForeName': 'Amal M', 'Initials': 'AM', 'LastName': 'AlShaibi', 'Affiliation': 'King Saud University, 37850, College of Medicine, Riyadh, Riyadh Province, Saudi Arabia; amalalshaibi@gmail.com.'}, {'ForeName': 'Norah Salman', 'Initials': 'NS', 'LastName': 'Alshabib', 'Affiliation': 'King Saud University, 37850, College of Medicine, Riyadh, Riyadh Province, Saudi Arabia; norah.alshabib@gmail.com.'}, {'ForeName': 'Rakan M', 'Initials': 'RM', 'LastName': 'Barghouthi', 'Affiliation': 'King Saud University, 37850, Family Medicine, Riyadh, Riyadh Province, Saudi Arabia; rakan.barghouthi@hotmail.com.'}, {'ForeName': 'Ebtihal Y', 'Initials': 'EY', 'LastName': 'Alyusuf', 'Affiliation': 'King Saud University, 37850, Internal medicine, Division of Endocrinology, Riyadh, --- Select One ---, Saudi Arabia; ealyusuf82@gmail.com.'}, {'ForeName': 'Anwar A', 'Initials': 'AA', 'LastName': 'Jammah', 'Affiliation': 'King Saud University, 37850, Internal Medicine, Division of Endocrinology, Riyadh, Riyadh Province, Saudi Arabia; drjammah@gmail.com.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2022.0110']
2049,35708047,"Using gait robotics to improve symptoms of Parkinson's disease: an open-label, pilot randomized controlled trial.","OBJECTIVES


People with Parkinson's Disease (PD) have difficulty participating in exercise. The primary objective of this pilot randomized controlled trial (RCT) was to determine if 8 weeks (2x per week) of bilateral exoskeleton (Exo) exercise results in positive changes in cognition and participation in adults with PD compared to exercising without an exoskeleton (Nxo) or wait-list control (Con).
DESIGN


Open-label, parallel, pilot randomized controlled trial.
SETTING


Neurorehabilitation clinic in a large urban centre.
SUBJECTS


Adults 50-85 years old with a confirmed diagnosis of PD.
INTERVENTIONS


Eight weeks of twice-weekly combined aerobic, strength and mobility exercise or waitlist control. Participants were randomly assigned to exercise with no exoskeleton (Nxo), exercise with the exoskeleton (Exo), or waitlist control (Con).
METHODS


Primary endpoints were change in cognitive function (SCOPA-COG) and mood. Secondary endpoints were change in gait speed, six-minute walk test (6MWT), freezing of gait, balance, and PDspecific health and quality of life outcomes. Safety endpoint was analysis of adverse events (AE).
RESULTS


Forty participated in the trial (Exo, n=13; Nxo, n=14; Con, n=13). Significant improvement in the Memory & Learning domain of the SCOPA-COG (p=.014) and 6MWT (p=.008) were detected for the Exo group compared to the Nxo and/or Con group. No other statistically significant between-groups effects were found. There were no serious or unanticipated AE.
CONCLUSIONS


Functional exercise with a low-profile overground exoskeleton showed promising results for improving memory and gait endurance in people with PD across HY stages I-IV.
CLINICAL REHABILITATION IMPACT


Exoskeletons can improve participation in high-intensity exercise.",2022,Significant improvement in the Memory & Learning domain of the SCOPA-COG (p=.014) and 6MWT (p=.008) were detected for the Exo group compared to the Nxo and/or Con group.,"['adults with PD', 'people with PD across HY stages', 'Neurorehabilitation clinic in a large urban centre', 'Adults 50-85 years old with a confirmed diagnosis of PD', 'Forty participated in the trial (Exo, n=13; Nxo, n=14; Con, n=13', ""People with Parkinson's Disease (PD""]","['exercising without an exoskeleton (Nxo) or wait-list control (Con', 'gait robotics', 'Functional exercise with a low-profile overground exoskeleton', 'bilateral exoskeleton (Exo) exercise', 'exercise with no exoskeleton (Nxo), exercise with the exoskeleton (Exo), or waitlist control (Con', 'twice-weekly combined aerobic, strength and mobility exercise or waitlist control']","[""symptoms of Parkinson's disease"", 'adverse events (AE', 'Memory & Learning domain of the SCOPA-COG', 'change in gait speed, six-minute walk test (6MWT), freezing of gait, balance, and PDspecific health and quality of life outcomes', 'change in cognitive function (SCOPA-COG) and mood', 'memory and gait endurance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",,0.0890396,Significant improvement in the Memory & Learning domain of the SCOPA-COG (p=.014) and 6MWT (p=.008) were detected for the Exo group compared to the Nxo and/or Con group.,"[{'ForeName': 'Pearl', 'Initials': 'P', 'LastName': 'Gryfe', 'Affiliation': 'Assistive Technology Clinic, Baycrest Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sexton', 'Affiliation': 'Institute of Biomedical Engineering, University of New Brunswick, Fredericton, New Brunswick, Canada.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'McGibbon', 'Affiliation': 'Institute of Biomedical Engineering, University of New Brunswick, Fredericton, New Brunswick, Canada - cmcgibb@unb.ca.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.22.07549-9']
2050,35708015,Effects of a Liquefied Petroleum Gas Stove Intervention on Gestational Blood Pressure: Intention-to-Treat and Exposure-Response Findings From the HAPIN Trial.,"BACKGROUND


Approximately 3 to 4 billion people worldwide are exposed to household air pollution, which has been associated with increased blood pressure (BP) in pregnant women in some studies.
METHODS


We recruited 3195 pregnant women in Guatemala, India, Peru, and Rwanda and randomly assigned them to intervention or control groups. The intervention group received a gas stove and fuel during pregnancy, while the controls continued cooking with solid fuels. We measured BP and personal exposure to PM 2.5 , black carbon and carbon monoxide 3× during gestation. We conducted an intention-to-treat and exposure-response analysis to determine if household air pollution exposure was associated with increased gestational BP.
RESULTS


Median 24-hour PM 2.5  dropped from 84 to 24 μg/m 3  after the intervention; black carbon and carbon monoxide decreased similarly. Intention-to-treat analyses showed an increase in systolic BP and diastolic BP in both arms during gestation, as expected, but the increase was greater in intervention group for both systolic BP (0.69 mm Hg [0.03-1.35];  P =0.04) and diastolic BP (0.62 mm Hg [0.05-1.19];  P =0.03). The exposure-response analyses suggested that higher exposures to household air pollution were associated with moderately higher systolic BP and diastolic BP; however, none of these associations reached conventional statistical significance.
CONCLUSIONS


In intention-to-treat, we found higher gestational BP in the intervention group compared with controls, contrary to expected. In exposure-response analyses, we found a slight increase in BP with higher exposure, but it was not statistically significant. Overall, an intervention with gas stoves did not markedly affect gestational BP.",2022,"The exposure-response analyses suggested that higher exposures to household air pollution were associated with moderately higher systolic BP and diastolic BP; however, none of these associations reached conventional statistical significance.
","['pregnant women in some studies', '3195 pregnant women in Guatemala, India, Peru, and Rwanda and randomly assigned them to intervention or control groups']","['Liquefied Petroleum Gas Stove Intervention', 'gas stove and fuel during pregnancy, while the controls continued cooking with solid fuels']","['BP and personal exposure to PM 2.5 , black carbon and carbon monoxide', 'Gestational Blood Pressure', 'BP', 'gestational BP', 'systolic BP and diastolic BP', 'diastolic BP', 'blood pressure (BP']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1268549', 'cui_str': 'Gas stove'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0557709', 'cui_str': 'Solid fuel'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0007010', 'cui_str': 'Carbon Black'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",3195.0,0.12676,"The exposure-response analyses suggested that higher exposures to household air pollution were associated with moderately higher systolic BP and diastolic BP; however, none of these associations reached conventional statistical significance.
","[{'ForeName': 'Wenlu', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA. (W.Y., K.S., A. Pillarisetti, T.F.C.).'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA. (W.Y., K.S., A. Pillarisetti, T.F.C.).'}, {'ForeName': 'Ashlinn', 'Initials': 'A', 'LastName': 'Quinn', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, CA (A.Q., M.J.).'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Population and Public Health Sciences, Keck School of Medicine of the University of Southern California, Los Angeles (J.L.).'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India (K.B.).'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Rosa', 'Affiliation': 'Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, United Kingdom (G.R.).'}, {'ForeName': 'Florien', 'Initials': 'F', 'LastName': 'Ndagijimana', 'Affiliation': 'Eagle Research Centre Limited, Kigali, Rwanda (F.N., J.d.D.N.).'}, {'ForeName': 'Jean de Dieu', 'Initials': 'JD', 'LastName': 'Ntivuguruzwa', 'Affiliation': 'Eagle Research Centre Limited, Kigali, Rwanda (F.N., J.d.D.N.).'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Thompson', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA. (L.M.T.).'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCracken', 'Affiliation': 'Department of Environmental Health Sciences, University of Georgia, Athens (J.P.M.).'}, {'ForeName': 'Anaité', 'Initials': 'A', 'LastName': 'Díaz-Artiga', 'Affiliation': 'Center for Health Studies, Universidad del Valle de Guatemala (A.D.-A.).'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, MD (J.P.R.).'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Papageorghiou', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, United Kingdom (A. Papageorghiou).""}, {'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Davila-Roman', 'Affiliation': 'Department of Medicine, Washington University in St. Louis, MO (V.G.D.-R.).'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Pillarisetti', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA. (W.Y., K.S., A. Pillarisetti, T.F.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, CA (A.Q., M.J.).'}, {'ForeName': 'Jiantong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA. (J.W.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nicolaou', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD. (L.N., W.C.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD. (L.N., W.C.).'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins (J.L.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA. (W.Y., K.S., A. Pillarisetti, T.F.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.122.19362']
2051,35707984,Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial.,"Importance


The optimal first-line mode of noninvasive respiratory support for acutely ill children is not known.
Objective


To evaluate the noninferiority of high-flow nasal cannula therapy (HFNC) as the first-line mode of noninvasive respiratory support for acute illness, compared with continuous positive airway pressure (CPAP), for time to liberation from all forms of respiratory support.
Design, Setting, and Participants


Pragmatic, multicenter, randomized noninferiority clinical trial conducted in 24 pediatric critical care units in the United Kingdom among 600 acutely ill children aged 0 to 15 years who were clinically assessed to require noninvasive respiratory support, recruited between August 2019 and November 2021, with last follow-up completed in March 2022.
Interventions


Patients were randomized 1:1 to commence either HFNC at a flow rate based on patient weight (n = 301) or CPAP of 7 to 8 cm H2O (n = 299).
Main Outcomes and Measures


The primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which a participant was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio of 0.75. Seven secondary outcomes were assessed, including mortality at critical care unit discharge, intubation within 48 hours, and use of sedation.
Results


Of the 600 randomized children, consent was not obtained for 5 (HFNC: 1; CPAP: 4) and respiratory support was not started in 22 (HFNC: 5; CPAP: 17); 573 children (HFNC: 295; CPAP: 278) were included in the primary analysis (median age, 9 months; 226 girls [39%]). The median time to liberation in the HFNC group was 52.9 hours (95% CI, 46.0-60.9 hours) vs 47.9 hours (95% CI, 40.5-55.7 hours) in the CPAP group (absolute difference, 5.0 hours [95% CI -10.1 to 17.4 hours]; adjusted hazard ratio 1.03 [1-sided 97.5% CI, 0.86-∞]). This met the criterion for noninferiority. Of the 7 prespecified secondary outcomes, 3 were significantly lower in the HFNC group: use of sedation (27.7% vs 37%; adjusted odds ratio, 0.59 [95% CI, 0.39-0.88]); mean duration of critical care stay (5 days vs 7.4 days; adjusted mean difference, -3 days [95% CI, -5.1 to -1 days]); and mean duration of acute hospital stay (13.8 days vs 19.5 days; adjusted mean difference, -7.6 days [95% CI, -13.2 to -1.9 days]). The most common adverse event was nasal trauma (HFNC: 6/295 [2.0%]; CPAP: 18/278 [6.5%]).
Conclusions and Relevance


Among acutely ill children clinically assessed to require noninvasive respiratory support in a pediatric critical care unit, HFNC compared with CPAP met the criterion for noninferiority for time to liberation from respiratory support.
Trial Registration


ISRCTN.org Identifier: ISRCTN60048867.",2022,"Seven secondary outcomes were assessed, including mortality at critical care unit discharge, intubation within 48 hours, and use of sedation.
","[' 573 children (HFNC: 295; CPAP: 278) were included in the primary analysis (median age, 9 months; 226 girls [39', '24 pediatric critical care units in the United Kingdom among 600 acutely ill children aged 0 to 15 years who were clinically assessed to require noninvasive respiratory support, recruited between August 2019 and November 2021, with last follow-up completed in March 2022', 'Acutely Ill Children Admitted to Pediatric Critical Care Units', 'acutely ill children']","['CPAP', 'HFNC', 'high-flow nasal cannula therapy (HFNC', 'High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy', 'continuous positive airway pressure (CPAP']","['sedation', 'mean duration of acute hospital stay', 'time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which a participant was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio of 0.75', 'mean duration of critical care stay', 'median time to liberation', 'mortality at critical care unit discharge, intubation within 48 hours, and use of sedation']","[{'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",600.0,0.275175,"Seven secondary outcomes were assessed, including mortality at critical care unit discharge, intubation within 48 hours, and use of sedation.
","[{'ForeName': 'Padmanabhan', 'Initials': 'P', 'LastName': 'Ramnarayan', 'Affiliation': 'Section of Anaesthetics, Pain Medicine, and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, England.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Richards-Belle', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Drikite', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Saull', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Izabella', 'Initials': 'I', 'LastName': 'Orzechowska', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Darnell', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Sadique', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, England.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lester', 'Affiliation': 'parent representative, Sussex, England.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Morris', 'Affiliation': ""Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, England.""}, {'ForeName': 'Lyvonne N', 'Initials': 'LN', 'LastName': 'Tume', 'Affiliation': 'School of Health and Society, University of Salford, Salford, England.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Davis', 'Affiliation': 'Paediatric Intensive Care Unit, Bristol Royal Hospital for Children, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, England.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust and NIHR Biomedical Research Centre, London, England.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Feltbower', 'Affiliation': 'Leeds Institute for Data Analytics, School of Medicine, University of Leeds, Leeds, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Grieve', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, England.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2022.9615']
2052,35707974,Effect of Fluid Bolus Administration on Cardiovascular Collapse Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial.,"Importance


Hypotension is common during tracheal intubation of critically ill adults and increases the risk of cardiac arrest and death. Whether administering an intravenous fluid bolus to critically ill adults undergoing tracheal intubation prevents severe hypotension, cardiac arrest, or death remains uncertain.
Objective


To determine the effect of fluid bolus administration on the incidence of severe hypotension, cardiac arrest, and death.
Design, Setting, and Participants


This randomized clinical trial enrolled 1067 critically ill adults undergoing tracheal intubation with sedation and positive pressure ventilation at 11 intensive care units in the US between February 1, 2019, and May 24, 2021. The date of final follow-up was June 21, 2021.
Interventions


Patients were randomly assigned to receive either a 500-mL intravenous fluid bolus (n = 538) or no fluid bolus (n = 527).
Main Outcomes and Measures


The primary outcome was cardiovascular collapse (defined as new or increased receipt of vasopressors or a systolic blood pressure <65 mm Hg between induction of anesthesia and 2 minutes after tracheal intubation, or cardiac arrest or death between induction of anesthesia and 1 hour after tracheal intubation). The secondary outcome was the incidence of death prior to day 28, which was censored at hospital discharge.
Results


Among 1067 patients randomized, 1065 (99.8%) completed the trial and were included in the primary analysis (median age, 62 years [IQR, 51-70 years]; 42.1% were women). Cardiovascular collapse occurred in 113 patients (21.0%) in the fluid bolus group and in 96 patients (18.2%) in the no fluid bolus group (absolute difference, 2.8% [95% CI, -2.2% to 7.7%]; P = .25). New or increased receipt of vasopressors occurred in 20.6% of patients in the fluid bolus group compared with 17.6% of patients in the no fluid bolus group, a systolic blood pressure of less than 65 mm Hg occurred in 3.9% vs 4.2%, respectively, cardiac arrest occurred in 1.7% vs 1.5%, and death occurred in 0.7% vs 0.6%. Death prior to day 28 (censored at hospital discharge) occurred in 218 patients (40.5%) in the fluid bolus group compared with 223 patients (42.3%) in the no fluid bolus group (absolute difference, -1.8% [95% CI, -7.9% to 4.3%]; P = .55).
Conclusions and Relevance


Among critically ill adults undergoing tracheal intubation, administration of an intravenous fluid bolus compared with no fluid bolus did not significantly decrease the incidence of cardiovascular collapse.
Trial Registration


ClinicalTrials.gov Identifier: NCT03787732.",2022,"Among critically ill adults undergoing tracheal intubation, administration of an intravenous fluid bolus compared with no fluid bolus did not significantly decrease the incidence of cardiovascular collapse.
","['1067 critically ill adults undergoing tracheal intubation with sedation and positive pressure ventilation at 11 intensive care units in the US between February 1, 2019, and May 24, 2021', 'critically ill adults undergoing tracheal intubation, administration of an', 'critically ill adults undergoing', '1067 patients randomized, 1065 (99.8%) completed the trial and were included in the primary analysis (median age, 62 years [IQR, 51-70 years]; 42.1% were women', 'critically ill adults', 'Critically Ill Patients Undergoing Tracheal Intubation']","['tracheal intubation', '500-mL intravenous fluid bolus (n\u2009=\u2009538) or no fluid bolus', 'intravenous fluid bolus', 'Fluid Bolus Administration']","['Death', 'Cardiovascular collapse', 'cardiac arrest', 'severe hypotension, cardiac arrest, and death', 'receipt of vasopressors', 'incidence of cardiovascular collapse', 'cardiovascular collapse (defined as new or increased receipt of vasopressors or a systolic blood pressure', 'incidence of death prior to day 28, which was censored at hospital discharge', 'death', 'systolic blood pressure', 'Cardiovascular Collapse', 'severe hypotension, cardiac arrest, or death']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",1067.0,0.585973,"Among critically ill adults undergoing tracheal intubation, administration of an intravenous fluid bolus compared with no fluid bolus did not significantly decrease the incidence of cardiovascular collapse.
","[{'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Alabama Heersink School of Medicine, Birmingham.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Section of Pulmonary, Critical Care, Allergy, and Immunologic Disease, Department of Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Shekhar', 'Initials': 'S', 'LastName': 'Ghamande', 'Affiliation': 'Division of Pulmonary Disease and Critical Care Medicine, Department of Medicine, Baylor Scott & White Medical Center, Temple, Texas.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Dargin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Prekker', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brewer', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Mississippi Medical Center, Jackson.'}, {'ForeName': 'Simanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Section of Pulmonary, Critical Care, Allergy, and Immunologic Disease, Department of Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Janna S', 'Initials': 'JS', 'LastName': 'Landsperger', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Heath D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Division of Pulmonary Disease and Critical Care Medicine, Department of Medicine, Baylor Scott & White Medical Center, Temple, Texas.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Robison', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Alabama Heersink School of Medicine, Birmingham.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wozniak', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stempek', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Barnes', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle.'}, {'ForeName': 'Olivia F', 'Initials': 'OF', 'LastName': 'Krol', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland.'}, {'ForeName': 'Alejandro C', 'Initials': 'AC', 'LastName': 'Arroliga', 'Affiliation': 'Division of Pulmonary Disease and Critical Care Medicine, Department of Medicine, Baylor Scott & White Medical Center, Temple, Texas.'}, {'ForeName': 'Tasnim', 'Initials': 'T', 'LastName': 'Lat', 'Affiliation': 'Division of Pulmonary Disease and Critical Care Medicine, Department of Medicine, Baylor Scott & White Medical Center, Temple, Texas.'}, {'ForeName': 'Sheetal', 'Initials': 'S', 'LastName': 'Gandotra', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Alabama Heersink School of Medicine, Birmingham.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Alabama Heersink School of Medicine, Birmingham.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Walters', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Dischert', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Nonas', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janz', 'Affiliation': 'University Medical Center New Orleans, New Orleans, Louisiana.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2022.9792']
2053,35707971,Optimal duration of dual antiplatelet therapy after stent-assisted coil embolization of unruptured intracranial aneurysms: A prospective randomized multicenter trial.,"Objective


Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs).
Methods


This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1:1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization.
Results


The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up.
Conclusion


This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.",2022,Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC.,"['patients with UIAs', '528 subjects (264 subjects in each group) and perform 1:1 randomization', '14 top-performing, high-volume Korean institutions specializing in coil embolization', 'patients with unruptured intracranial aneurysms (UIAs', 'patients undergoing SAC']","['Stent-assisted coil embolization (SAC', 'dual antiplatelet therapy', 'dual antiplatelet therapy after stent-assisted coil embolization', 'long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy', 'short-term (6 months) and long-term (12 months) dual antiplatelet therapy', 'aspirin and clopidogrel']","['assessment of thromboembolic complications', 'safety and efficacy', 'Delayed thromboembolic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0522644', 'cui_str': 'Embolization coil'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0522644', 'cui_str': 'Embolization coil'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0124702,Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC.,"[{'ForeName': 'Seung Pil', 'Initials': 'SP', 'LastName': 'Ban', 'Affiliation': 'Departments of Neurosurgery, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'O-Ki', 'Initials': 'OK', 'LastName': 'Kwon', 'Affiliation': 'Departments of Neurosurgery, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Young Deok', 'Initials': 'YD', 'LastName': 'Kim', 'Affiliation': 'Departments of Neurosurgery, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Bum-Tae', 'Initials': 'BT', 'LastName': 'Kim', 'Affiliation': 'Departments of Neurosurgery, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Jae Sang', 'Initials': 'JS', 'LastName': 'Oh', 'Affiliation': 'Departments of Neurosurgery, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.'}, {'ForeName': 'Kang Min', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Departments of Neurosurgery, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chang Hyeun', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Departments of Neurosurgery, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Departments of Neurosurgery, Keimyung University Dongsan Medical Center, Daegu, Korea.'}, {'ForeName': 'Jai Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': ""Departments of Neurosurgery, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.""}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': ""Departments of Neurosurgery, Uijeongbu St. Mary's Hospital, The Catholic University of Korea College of Medicine, Uijeongbu, Korea.""}, {'ForeName': 'Yong Cheol', 'Initials': 'YC', 'LastName': 'Lim', 'Affiliation': 'Departments of Neurosurgery, Ajou University School of Medicine, Ajou University Medical Center, Suwon, Korea.'}, {'ForeName': 'Hyoung Soo', 'Initials': 'HS', 'LastName': 'Byoun', 'Affiliation': 'Departments of Neurosurgery, Chungnam National University Sejong Hospital, Sejong, Korea.'}, {'ForeName': 'Sukh Que', 'Initials': 'SQ', 'LastName': 'Park', 'Affiliation': 'Departments of Neurosurgery, Soonchunhyang University Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Joonho', 'Initials': 'J', 'LastName': 'Chung', 'Affiliation': 'Departments of Neurosurgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Keun Young', 'Initials': 'KY', 'LastName': 'Park', 'Affiliation': 'Departments of Neurosurgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung Cheol', 'Initials': 'JC', 'LastName': 'Park', 'Affiliation': 'Departments of Neurosurgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Hyon-Jo', 'Initials': 'HJ', 'LastName': 'Kwon', 'Affiliation': 'Departments of Neurosurgery, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Korean Neurosurgical Society,['10.3340/jkns.2022.0082']
2054,35707932,Effects of the Short Stitch Technique for Midline Abdominal Closure on Incisional Hernia (ESTOIH): Randomized Clinical Trial.,"BACKGROUND


Incisional hernia remains a frequent problem after midline laparotomy. This study compared a short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material.
METHODS


A prospective, multicentre, parallel-group, double-blind, randomized, controlled superiority trial was designed for the elective setting. Adult patients were randomly assigned by computer-generated sequence to fascial closure using a short stitch (5 to 8 mm every 5 mm, USP 2-0, single thread HR 26 mm needle) or long stitch technique (10 mm every 10 mm, USP 1, double loop, HR 48 mm needle) with a poly-4-hydroxybutyrate-based suture material (Monomax®). Incisional hernia assessed by ultrasound 1 year after surgery was the primary outcome.
RESULTS


The trial randomized 425 patients to short (n = 215) or long stitch technique (n = 210) of whom 414 (97.4 per cent) completed 1 year of follow-up. In the short stitch group, the fascia was closed with more stitches (46 (12 s.d.) versus 25 (7 s.d.); P < 0.001) and higher suture-to-wound length ratio (5.3 (2.2 s.d.) versus 4.0 (1.3 s.d.); P < 0.001). At 1 year, seven of 210 (3.3 per cent) patients in the short and 13 of 204 (6.4 per cent) patients in the long stitch group developed incisional hernia (odds ratio 1.97, 95 per cent confidence interval 0.77 to 5.05; P = 0.173).
CONCLUSION


The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches. Registration number: NCT01965249 (http://www.clinicaltrials.gov).",2022,The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches.,"['425 patients to short (n\u2009=\u2009215) or', 'Adult patients', 'n\u2009=\u2009210) of whom 414 (97.4 per cent) completed 1 year of follow-up', 'Midline Abdominal Closure on Incisional Hernia (ESTOIH']","['short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material', 'poly-4-hydroxybutyrate-based suture material (Monomax®', 'computer-generated sequence to fascial closure using a short stitch (5 to 8\u2005mm every 5\u2005mm, USP 2-0, single thread HR 26\u2005mm needle) or long stitch technique', 'long stitch technique', 'Short Stitch Technique']","['Incisional hernia', '1-year incisional hernia development', 'higher suture-to-wound length ratio', 'incisional hernia']","[{'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C3873692', 'cui_str': 'Absorbent'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0038969', 'cui_str': 'Surgical suture'}, {'cui': 'C0000503', 'cui_str': '4-hydroxybutyrate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",425.0,0.599714,The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches.,"[{'ForeName': 'René H', 'Initials': 'RH', 'LastName': 'Fortelny', 'Affiliation': 'Wilhelminenspital, Allgemein, Viszeral und Tumorchirurgie, Vienna, Austria.'}, {'ForeName': 'Dorian', 'Initials': 'D', 'LastName': 'Andrade', 'Affiliation': 'Ludwig-Maximilians-Universität (LMU) Munich, LMU University Hospital, Department of General, Visceral and Transplantation Surgery, Munich, Germany.'}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Schirren', 'Affiliation': 'Ludwig-Maximilians-Universität (LMU) Munich, LMU University Hospital, Department of General, Visceral and Transplantation Surgery, Munich, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Baumann', 'Affiliation': 'Aesculap AG, Department of Medical Scientific Affairs, Am Aesculap Platz, Tuttlingen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Riedl', 'Affiliation': 'Alb Fils Klinik GmbH, Klinik am Eichert, Allgemeinchirurgie, Göppingen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Reisensohn', 'Affiliation': 'Alb Fils Klinik GmbH, Klinik am Eichert, Allgemeinchirurgie, Göppingen, Germany.'}, {'ForeName': 'Jan Ludolf', 'Initials': 'JL', 'LastName': 'Kewer', 'Affiliation': 'Klinikum Landkreis Tuttlingen, Klinik für Allgemein, Viszeral und Gefäßchirurgie, Tuttlingen, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hoelderle', 'Affiliation': 'Klinikum Landkreis Tuttlingen, Klinik für Allgemein, Viszeral und Gefäßchirurgie, Tuttlingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Shamiyeh', 'Affiliation': 'Kepler Universitätsklinikum GmbH, Klinik für Allgemein und Viszeralchirurgie, Linz, Austria.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Klugsberger', 'Affiliation': 'Kepler Universitätsklinikum GmbH, Klinik für Allgemein und Viszeralchirurgie, Linz, Austria.'}, {'ForeName': 'Theo David', 'Initials': 'TD', 'LastName': 'Maier', 'Affiliation': 'Robert-Bosch-Krankenhaus, Allgemein und Viszeralchirurgie, Stuttgart, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Schumacher', 'Affiliation': 'Städtisches Klinikum Braunschweig, Chirurgische Klinik, Braunschweig, Germany.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Köckerling', 'Affiliation': 'Vivantes Humboldt-Hospital, Hernia Center, Berlin, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Pession', 'Affiliation': 'Universitätsklinikum Frankfurt, Zentrum der Chirurgie, Klinik für Allgemein und Viszeralchirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hofmann', 'Affiliation': 'Wilhelminenspital, Allgemein, Viszeral und Tumorchirurgie, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Albertsmeier', 'Affiliation': 'Ludwig-Maximilians-Universität (LMU) Munich, LMU University Hospital, Department of General, Visceral and Transplantation Surgery, Munich, Germany.'}]",The British journal of surgery,['10.1093/bjs/znac194']
2055,35708386,A comparative study on the surgical options for male rectal prolapse.,"Purpose


Rectal prolapse is known to be a rare condition in males compared to females. This study aimed to analyse the frequency of male rectal prolapse and compare the results of different surgical approaches performed at a single centre.
Patients and Methods


The authors included patients who underwent surgical treatment for rectal prolapse from March 2016 to February 2021. The proportion of males, mean age and recurrence rates were calculated. Patients were divided into two groups, transanal approach and laparoscopic abdominal approach group, to identify the para-operative parameters including functional tests.
Results


A total of 56 males, comprising 23.7% (56/236) of all patients. The mean age was 60.8 years, with a recurrence rate of 7 cases (12.5%) during 7.2 months of follow-up. Forty patients underwent transanal procedures, and fifteen underwent laparoscopic abdominal procedures. The mean operative time was longer in the laparoscopic group (transanal vs. abdominal, 57.5 vs. 70.6 min, P < 0.003), and intra-operative bleeding was greater in the transanal group (12.4 vs. 3.4 ml, P < 0.001). Full-layer prolapse (36.8 vs. 81.2% P = 0.003) and longer length (5.6 vs. 7.8 cm, P = 0.048) were more common in laparoscopic group. Time to feeding resumption was shorter after the transanal group (1.2 vs. 1.7 days, P = 0.028). There was no difference between the groups in terms of post-operative complications and recurrence rates. Both Wexner's constipation and incontinence scores showed significant improvement postoperatively.
Conclusion


The frequency of male rectal prolapse was 23.7%, and perioperative factors differed between transanal and abdominal approaches, but recurrence rates and functional test results did not differ significantly.",2022,"The mean operative time was longer in the laparoscopic group (transanal vs. abdominal, 57.5 vs. 70.6 min, P < 0.003), and intra-operative bleeding was greater in the transanal group (12.4 vs. 3.4 ml, P < 0.001).","['The mean age was 60.8 years, with a recurrence rate of 7 cases (12.5%) during 7.2 months of follow-up', 'patients who underwent surgical treatment for rectal prolapse from March 2016 to February 2021', 'Forty patients underwent transanal procedures, and fifteen underwent laparoscopic abdominal procedures', 'A total of 56 males, comprising 23.7% (56/236) of all patients', 'male rectal prolapse']",['transanal approach and laparoscopic abdominal approach'],"['intra-operative bleeding', 'Time to feeding resumption', 'recurrence rates and functional test results', 'longer length', 'mean operative time', 'Full-layer prolapse', 'post-operative complications and recurrence rates', 'frequency of male rectal prolapse', 'proportion of males, mean age and recurrence rates']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034888', 'cui_str': 'Rectal prolapse'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034888', 'cui_str': 'Rectal prolapse'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",56.0,0.0342595,"The mean operative time was longer in the laparoscopic group (transanal vs. abdominal, 57.5 vs. 70.6 min, P < 0.003), and intra-operative bleeding was greater in the transanal group (12.4 vs. 3.4 ml, P < 0.001).","[{'ForeName': 'Han Deok', 'Initials': 'HD', 'LastName': 'Kwak', 'Affiliation': 'Department of Surgery, Chonnam National University Hospital, College of Medicine, Chonnam National University, Gwangju, South Korea.'}, {'ForeName': 'Jun Seong', 'Initials': 'JS', 'LastName': 'Chung', 'Affiliation': 'Department of Surgery, Chonnam National University Hospital, Gwangju, South Korea.'}, {'ForeName': 'Jae Kyun', 'Initials': 'JK', 'LastName': 'Ju', 'Affiliation': 'Department of Surgery, Chonnam National University Hospital, College of Medicine, Chonnam National University, Gwangju, South Korea.'}]",Journal of minimal access surgery,['10.4103/jmas.jmas_214_21']
2056,35708380,"Comparison of laparoscopic and open surgery in hepatic hydatid disease in children: Feasibility, efficacy and safety.","Background


: Surgery continues to be the mainstay of treatment of hydatid cysts of the liver. Laparoscopy provides a lesser invasive tool for achieving results same as with the established open surgical techniques. The purpose of the study was to evaluate the feasibility and safety of laparoscopic management of hepatic hydatid disease in children.
Patients and Methods


It was a prospective randomised study conducted over a period of 7 years. Children with Gharbi Type I, II, III cysts, ≤3 cysts and superficial accessible cysts were treated laparoscopically and their outcomes were compared with matched controls treated by open approach.
Results


Sixty patients were included in the study with thirty patients in each matched group. Thirty paediatric patients (male 12:female 18) with 35 liver hydatid cysts underwent laparoscopic surgery. The mean cyst size was 8.8 ± 2.39 cm. Two patients needed conversion to open. No significant spillage of cyst contents was observed in any of the patients. Duration of hospital stay, time to removal of drains, duration of parenteral analgesia, severity of pain in postoperative period, time to ambulation and time to return to full orals were significantly lower in laparoscopic group compared to open group. Complication rates in both the groups were similar.
Conclusion


With proper patient selection, laparoscopic management of hydatid cysts of the liver in children is feasible and safe option with low morbidity, low rates of conversion and minimal complications.",2022,"Complication rates in both the groups were similar.
","['Children with Gharbi Type I, II, III cysts, ≤3 cysts and superficial accessible cysts', 'children', 'Thirty paediatric patients (male 12:female 18) with 35 liver hydatid cysts underwent', 'Sixty patients were included in the study with thirty patients in each matched group']","['\n\n\n', 'Laparoscopy', 'laparoscopic surgery', 'laparoscopic management', 'laparoscopic and open surgery']","['mean cyst size', 'Complication rates', 'Duration of hospital stay, time to removal of drains, duration of parenteral analgesia, severity of pain in postoperative period, time to ambulation and time to return to full orals', 'spillage of cyst contents', 'feasibility and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0013502', 'cui_str': 'Echinococcosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.00864231,"Complication rates in both the groups were similar.
","[{'ForeName': 'Pirzada Faisal', 'Initials': 'PF', 'LastName': 'Masood', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Gowhar Nazir', 'Initials': 'GN', 'LastName': 'Mufti', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Sajad Ahmad', 'Initials': 'SA', 'LastName': 'Wani', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Khurshid', 'Initials': 'K', 'LastName': 'Sheikh', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Aejaz Ahsan', 'Initials': 'AA', 'LastName': 'Baba', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Nisar Ahamd', 'Initials': 'NA', 'LastName': 'Bhat', 'Affiliation': 'Department of Paediatric Surgery, SKIMS, Srinagar, Jammu and Kashmir, India.'}, {'ForeName': 'Raashid', 'Initials': 'R', 'LastName': 'Hamid', 'Affiliation': 'Department of Paediatric Surgery, GMC, Srinagar, Jammu and Kashmir, India.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_220_20']
2057,35708378,Comparative study on gasless laparoscopy using a new device versus conventional laparoscopy for surgical management of postmenopausal patients.,"Objective


To compare gasless laparoscopy with conventional laparoscopy for the surgical management of postmenopausal patients.
Methods


The medical records of 80 postmenopausal patients who underwent laparoscopic surgeries between February 2016 and February 2020 were reviewed. Forty patients underwent gasless laparoscopy and 40 patients underwent conventional single-port access (SPA) laparoscopy. The two groups were compared in terms of surgical outcomes.
Results


: Of 80 patients, 42 underwent adnexal surgeries and 38 underwent uterine surgeries such as total hysterectomy or myomectomy. Between the gasless SPA and conventional SPA laparoscopic groups, no significant differences were observed in terms of age, body mass index, parity or history of previous abdominal surgery. The mean retraction setup time from skin incision was 6.8 ± 1.2 min with gasless laparoscopic surgery. There was no significant difference in mean total operation times for the gasless (71.3 ± 31.4 min) and conventional (82.5 ± 36.4 min) groups. There was also no significant difference between the groups in terms of operation type, laparotomy conversion rate or duration of hospitalisation. There were no major complications in either group.
Conclusions


Gasless laparoscopy is a safe and feasible alternative to conventional laparoscopy for postmenopausal women.",2022,"There was also no significant difference between the groups in terms of operation type, laparotomy conversion rate or duration of hospitalisation.","['postmenopausal women', '80 patients, 42 underwent adnexal surgeries and 38 underwent', 'Forty patients underwent', '80 postmenopausal patients who underwent laparoscopic surgeries between February 2016 and February 2020 were reviewed', 'postmenopausal patients']","['gasless laparoscopy using a new device versus conventional laparoscopy', 'Gasless laparoscopy', 'conventional single-port access (SPA) laparoscopy', 'uterine surgeries such as total hysterectomy or myomectomy', 'gasless SPA and conventional SPA laparoscopic', 'gasless laparoscopy', 'gasless laparoscopy with conventional laparoscopy', 'gasless laparoscopic surgery']","['mean total operation times', 'mean retraction setup time', 'age, body mass index, parity or history of previous abdominal surgery', 'operation type, laparotomy conversion rate or duration of hospitalisation', 'major complications']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3665370', 'cui_str': 'Operation on uterus'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",80.0,0.0239109,"There was also no significant difference between the groups in terms of operation type, laparotomy conversion rate or duration of hospitalisation.","[{'ForeName': 'Jong Ha', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': ""Department of Obstetrics and Gynecology, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon Metropolitan City, South Korea.""}, {'ForeName': 'Bo Wook', 'Initials': 'BW', 'LastName': 'Kim', 'Affiliation': ""Department of Obstetrics and Gynecology, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon Metropolitan City, South Korea.""}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_82_21']
2058,35708364,Efficacy of endoscopic anterior fundoplication with a novel ultrasonic surgical endostapler for gastroesophageal reflux disease: Six-month results from a multicenter prospective trial.,"Background and Objectives


Endoscopic therapy is an option for the treatment of refractory gastroesophageal reflux disease (GERD). We aimed to evaluate the efficacy and safety of transoral incisionless fundoplication with the Medigus ultrasonic surgical endostapler (MUSE™) for refractory GERD.
Materials and Methods


Patients with 2 years of documented GERD symptoms and at least 6 months of proton-pump inhibitors (PPIs) therapy were enrolled in four medical centers from March 2017 to March 2019. The GERD health-related quality of life (HRQL) score, GERD questionnaire score, total acid exposure on esophageal pH probe monitoring, the gastroesophageal flap valve (GEFV), esophageal manometry, and PPIs dosage were compared between the pre- and post-MUSE procedure. All of the side effects were recorded.
Results


A reduction of at least 50% in the GERD-HRQL score was observed in 77.8% (42/54) patients. Most patients 74.1% (40/54) discontinued PPIs and 11.1% (6/54) reported a ≥50% dose reduction. The percentage of patients who had normalized acid exposure time after the procedure was 46.9% (23/49). The existence of hiatal hernia at baseline was negatively correlated with the curative effect. Mild pain was common and resolved within 48 h postprocedure. Serious complications were pneumoperitoneum (one case), mediastinal emphysema combined with pleural effusion (two cases).
Conclusions


Endoscopic anterior fundoplication with MUSE was an effective treatment for refractory GERD, but still needs refinement and improvement in safety aspect. Esophageal hiatal hernia may affect the efficacy of MUSE. (www.chictr.org.cn, ChiCTR2000034350).",2022,"Serious complications were pneumoperitoneum (one case), mediastinal emphysema combined with pleural effusion (two cases).
","['refractory gastroesophageal reflux disease (GERD', 'Patients with 2 years of documented GERD symptoms and at least 6 months of proton-pump inhibitors (PPIs) therapy were enrolled in four medical centers from March 2017 to March 2019', 'gastroesophageal reflux disease']","['MUSE', 'transoral incisionless fundoplication with the Medigus ultrasonic surgical endostapler (MUSE™', 'endoscopic anterior fundoplication with a novel ultrasonic surgical endostapler']","['Mild pain', 'normalized acid exposure time', 'efficacy and safety', 'GERD-HRQL score', 'hiatal hernia', 'GERD health-related quality of life (HRQL) score, GERD questionnaire score, total acid exposure on esophageal pH probe monitoring, the gastroesophageal flap valve (GEFV), esophageal manometry, and PPIs dosage']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C2366566', 'cui_str': 'Muse'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0192499', 'cui_str': 'Esophagogastric fundoplasty'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3489393', 'cui_str': 'Hiatal hernia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1504385', 'cui_str': 'Oesophageal pH'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0199873', 'cui_str': 'Esophageal manometry'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0288833,"Serious complications were pneumoperitoneum (one case), mediastinal emphysema combined with pleural effusion (two cases).
","[{'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wan', 'Affiliation': ""Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shengliang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Renji Hospital of Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroesophageal Reflux Disease, Chinese PLA Rocket Force Characteristic Medical Center, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ai', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}]",Endoscopic ultrasound,['10.4103/EUS-D-21-00244']
2059,35708359,"Comparison of specimen quality among the standard suction, slow-pull, and wet suction techniques for EUS-FNA: A multicenter, prospective, randomized controlled trial.","Background and Objectives


Standard suction technique (SST), slow-pull technique (SPT), and wet suction technique (WEST) of EUS-FNA are designed to improve the diagnostic yields of solid and solid-cystic lesions. We conducted a multicenter, prospective, randomized crossover trial to compare SST, SPT, and WEST on specimen quality and diagnostic accuracy using a 22G needle.
Methods


Patients with solid or solid-cystic lesions referred for EUS-FNA at four tertiary hospitals from December 2017 to August 2019 were considered eligible. All lesions were sampled using a 22G needle by the three techniques performed consecutively in a randomized order. The primary outcome was quality of the specimen acquired by each technique regarding blood contamination, tissue integrity and cellularity for diagnosis, graded on a predefined scale. The secondary outcomes were the diagnostic yield of EUS-FNA and the incidence of adverse events. ClinicalTrial. gov registration number: NCT03567863.
Results


A total of 300 patients (mean age, 60.6 years, 188 men) were enrolled. WEST was superior (mean score 4.02 ± 1.51) over SST (3.67 ± 1.57, P = 0.018), but comparable to SPT (3.83 ± 1.55, P = 0.370) in overall specimen quality evaluation. WEST produced better tissue integrity (1.42 ± 0.74) and higher cellularity (1.32 ± 0.80) than SST and SPT. SPT (1.43 ± 0.69) was superior to SST (1.27 ± 0.72, P = 0.004) and WEST (1.28 ± 0.71, P = 0.006) in avoiding blood contamination. WEST achieved a diagnostic accuracy of 74.7%, higher than SST (64.4%, P = 0.007) and SPT (65.0%, P = 0.012). One bleeding event occurred with a pancreatic lesion.
Conclusions


WEST was comparable to SPT and superior to SST in the overall quality of the specimen and achieved highest diagnostic yield.",2022,"Conclusions


WEST was comparable to SPT and superior to SST in the overall quality of the specimen and achieved highest diagnostic yield.","['300 patients (mean age, 60.6 years, 188 men) were enrolled', 'Patients with solid or solid-cystic lesions referred for EUS-FNA at four tertiary hospitals from December 2017 to August 2019 were considered eligible']","['SST, SPT, and WEST', 'standard suction, slow-pull, and wet suction techniques for EUS-FNA', ' and Objectives\n\n\nStandard suction technique (SST), slow-pull technique (SPT), and wet suction technique (WEST) of EUS-FNA']","['quality of the specimen acquired by each technique regarding blood contamination, tissue integrity and cellularity for diagnosis, graded on a predefined scale', 'diagnostic yield of EUS-FNA and the incidence of adverse events', 'diagnostic accuracy', 'bleeding event', 'overall specimen quality evaluation', 'specimen quality and diagnostic accuracy', 'tissue integrity']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",300.0,0.061711,"Conclusions


WEST was comparable to SPT and superior to SST in the overall quality of the specimen and achieved highest diagnostic yield.","[{'ForeName': 'Tian-Yin', 'Initials': 'TY', 'LastName': 'Chen', 'Affiliation': 'Endoscopy Centre and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ji-Wang', 'Initials': 'JW', 'LastName': 'Cao', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Department of Pancreatic Surgery, Pancreatic Disease Institute, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Pathology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastroenterology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li-Mei', 'Initials': 'LM', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Di', 'Affiliation': 'Department of Pancreatic Surgery, Pancreatic Disease Institute, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Pathology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Yi-Qun', 'Initials': 'YQ', 'LastName': 'Zhang', 'Affiliation': 'Endoscopy Centre and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Zhou', 'Affiliation': 'Endoscopy Centre and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",Endoscopic ultrasound,['10.4103/EUS-D-21-00163']
2060,35708631,"KGR-BG1, a Standardized Korean Black Ginseng Extract, Has No Significant Effects on Head or Face Temperature Compared with Korean Red Ginseng Extract and a Placebo.","There is a lack of studies on the effects of Korean ginseng ( Panax ginseng  C.A. Meyer) on face or body temperature. Therefore, in this study, we evaluated the effects of a black ginseng extract, KGR-BG1, on head and face temperatures and compared them with those of red ginseng extract and a placebo. We assessed their safety and tolerability and examined changes in the serum levels of biomarkers associated with immune responses, as well as with glucose and lipid metabolism. A randomized, double-blind, placebo-controlled study was conducted with 180 participants. The participants were randomly assigned to the KGR-BG1, red ginseng extract, or placebo group. Each group received a 1500 mg oral dose of their respective substances containing 1000 mg of the active component or placebo twice daily for 6 weeks. After treatment, changes in the head, face, and body temperature were measured, and serum biomarkers were evaluated. A total of 172 participants completed the evaluation after 6 weeks of treatment. No significant differences were observed in the head, face, and body temperatures among the treatment groups. After 6 weeks of treatment, the serum levels of biomarkers associated with inflammation, glucose metabolism, and lipid metabolism were similar to the baseline levels in all treatment groups. KGR-BG1 was well-tolerated compared with red ginseng extract and placebo. KGR-BG1 did not significantly alter head, face, or body temperature, or serum biomarker levels, and it was well tolerated in healthy volunteers over 6 weeks of treatment. Study Registration: Registered at Clinical Research Information Service (CRIS; https://cris.nih.go.kr) as KCT0003126.",2022,"After 6 weeks of treatment, the serum levels of biomarkers associated with inflammation, glucose metabolism, and lipid metabolism were similar to the baseline levels in all treatment groups.","['172 participants completed the evaluation after 6 weeks of treatment', '180 participants', 'healthy volunteers']","['black ginseng extract, KGR-BG1', '1500\u2009mg oral dose of their respective substances containing 1000\u2009mg of the active component or placebo', 'Korean ginseng ( Panax ginseng', 'red ginseng extract and a placebo', 'KGR-BG1, red ginseng extract, or placebo', 'red ginseng extract and placebo', 'placebo', 'Korean Red Ginseng Extract and a Placebo']","['serum levels of biomarkers associated with inflammation, glucose metabolism, and lipid metabolism', 'head, face, and body temperatures', 'KGR-BG1', 'Head or Face Temperature', 'changes in the head, face, and body temperature', 'head, face, or body temperature, or serum biomarker levels', 'safety and tolerability']","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1119918', 'cui_str': 'Ginseng Preparation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",172.0,0.0377681,"After 6 weeks of treatment, the serum levels of biomarkers associated with inflammation, glucose metabolism, and lipid metabolism were similar to the baseline levels in all treatment groups.","[{'ForeName': 'Sang-In', 'Initials': 'SI', 'LastName': 'Park', 'Affiliation': 'Department of Pharmacology, College of Medicine, Kangwon National University, Chuncheon, Korea.'}, {'ForeName': 'Sungjeong', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Inha University, Incheon, Korea.'}, {'ForeName': 'Hwa-Young', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Science and Technology, Graduate School, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Sung-Vin', 'Initials': 'SV', 'LastName': 'Yim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul, Korea.'}, {'ForeName': 'Bo-Hyung', 'Initials': 'BH', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul, Korea.'}]",Journal of medicinal food,['10.1089/jmf.2022.K.0007']
2061,35708621,Short-Term Efficacy of a Childhood Obesity Prevention Program Designed to Pair Feeding Content with Nutrition Education.,"Background:  Family-based programs show considerable promise in preventing overweight and obesity in young children. However, dissemination is difficult because significant participant and staff involvement is required. This study examined the short-term efficacy of adding parental feeding content to a widely-used nutrition education curriculum for families in low-resourced communities comparing the influence of two delivery methods (in-class and online) on parents' feeding knowledge, practices, and styles.  Methods:  In this cluster randomized controlled trial, parents of 2- to 8-year-old children enrolled in the EFNEP (Expanded Food and Nutrition Education Program) in Colorado and Washington were randomly assigned to: in-class nutrition education only, in-class nutrition education with in-class feeding content, or in-class nutrition education with online feeding content. Data from the 382 participants who completed both pretest and posttest assessments are reported in this study.  Results:  Multilevel analyses showed empirical support for the influence of the program on parents' feeding knowledge, practices, and styles. Online and in-class methods were equally effective in delivering feeding content in low-resourced communities. Consistent effects were seen across the two delivery methods for encouraging children to try new foods ( p  < 0.05), use of child-centered feeding practices ( i.e.,  greater responsiveness,  p  < 0.05), child involvement in food preparation ( p  < 0.05), and understanding the number of presentations often necessary for child acceptance of a new food ( p  < 0.001). Location and language differences were seen across some constructs.  Conclusions:  This study demonstrates the efficacy of in-class and online approaches to feeding highlighting the program's positive effects on promoting healthy feeding behaviors for parents of children in low-resourced families. ClinicalTrials.gov Identifier: NCT03170700.",2022,"Consistent effects were seen across the two delivery methods for encouraging children to try new foods ( p  < 0.05), use of child-centered feeding practices ( i.e.,  greater responsiveness,  p  < 0.05), child involvement in food preparation ( p  < 0.05), and understanding the number of presentations often necessary for child acceptance of a new food ( p  < 0.001).","['parents of 2- to 8-year-old children enrolled in the EFNEP (Expanded Food and Nutrition Education Program) in Colorado and Washington', '382 participants who completed both pretest and posttest assessments are reported in this study', 'parents of children in low-resourced families', 'young children']","['class nutrition education only, in-class nutrition education with in-class feeding content, or in-class nutrition education with online feeding content', 'parental feeding content to a widely-used nutrition education curriculum']","['child involvement in food preparation', 'overweight and obesity', 'healthy feeding behaviors']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",382.0,0.0118481,"Consistent effects were seen across the two delivery methods for encouraging children to try new foods ( p  < 0.05), use of child-centered feeding practices ( i.e.,  greater responsiveness,  p  < 0.05), child involvement in food preparation ( p  < 0.05), and understanding the number of presentations often necessary for child acceptance of a new food ( p  < 0.001).","[{'ForeName': 'Sheryl O', 'Initials': 'SO', 'LastName': 'Hughes', 'Affiliation': ""Department of Pediatrics, USDA/ARS Children's Nutrition Research Center at Baylor College of Medicine, Houston, TX, USA.""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Power', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Baker', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Ft. Collins, CO, USA.'}, {'ForeName': 'Karen V', 'Initials': 'KV', 'LastName': 'Barale', 'Affiliation': 'Washington State University Extension, Tacoma, WA, USA.'}, {'ForeName': 'M Catalina', 'Initials': 'MC', 'LastName': 'Aragon', 'Affiliation': 'Washington State University Extension, Tacoma, WA, USA.'}, {'ForeName': 'Jane D', 'Initials': 'JD', 'LastName': 'Lanigan', 'Affiliation': 'Department of Human Development, Washington State University, Vancouver, WA, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': 'Department of Human Development, Washington State University Extension, Seattle, WA, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Silva Garcia', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Auld', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Ft. Collins, CO, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Johnston', 'Affiliation': 'Department of Health and Human Performance, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Nilda', 'Initials': 'N', 'LastName': 'Micheli', 'Affiliation': ""Department of Pediatrics, USDA/ARS Children's Nutrition Research Center at Baylor College of Medicine, Houston, TX, USA.""}]",Childhood obesity (Print),['10.1089/chi.2022.0030']
2062,35708579,Improving Rates of Vitamin D Supplementation in Somali Immigrant Infants: A Prospective Interventional Pilot Trial.,"PURPOSE


Rates of vitamin D deficiency and nutritional rickets have been rising over the past several decades, particularly in high-risk infants. This pilot study assessed the impact of providing free vitamin D supplements, a culturally-appropriate educational brochure, and a brief counseling session about the importance of both vitamin D supplementation and breastfeeding to the parents of Somali infants at routine office visits from newborn through 6 months of age at three Federally Qualified Health Centers in Colorado. We also assessed the impact this intervention had on rates of breastfeeding.
METHODS


Twenty-five Somali infants aged 24 weeks or less were identified by searching electronic health records and enrolled into a historic control group. The parents were then surveyed by phone regarding breastfeeding and vitamin D supplementation. Subsequently, 37 families with newborn Somali infants were identified and enrolled into the intervention arm of the trial.
RESULTS


The intervention group had a higher rate of vitamin D supplementation compared to the historical control group (67 vs. 48 percent, p=0.011) without significantly impacting breastfeeding rates.
CONCLUSION


These results suggest a practical way to increase vitamin D status in this high-risk population. Trial not registered as it was a pilot study, not a phase II to IV prospective clinical trial.",2022,"The intervention group had a higher rate of vitamin D supplementation compared to the historical control group (67 vs. 48 percent, p=0.011) without significantly impacting breastfeeding rates.
","['37 families with newborn Somali infants', 'Twenty-five Somali infants aged 24 weeks or less were identified by searching electronic health records and enrolled into a historic control group', 'Somali Immigrant Infants', 'high-risk infants', 'parents of Somali infants at routine office visits from newborn through 6 months of age at three Federally Qualified Health Centers in Colorado']","['free vitamin D supplements', 'Vitamin D Supplementation', 'vitamin D supplementation']","['breastfeeding rates', 'rate of vitamin D supplementation', 'vitamin D status', 'rates of breastfeeding']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0337847', 'cui_str': 'Somalis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0419437', 'cui_str': 'High risk infant'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",37.0,0.110973,"The intervention group had a higher rate of vitamin D supplementation compared to the historical control group (67 vs. 48 percent, p=0.011) without significantly impacting breastfeeding rates.
","[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Cook', 'Affiliation': 'North Colorado Family Medicine Residency Program, Greeley, Colorado.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kimball', 'Affiliation': 'Sunrise Community Health, Evans, Colorado.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zittleman', 'Affiliation': 'High Plains Research Network, University of Colorado Denver.'}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Huntington', 'Affiliation': 'Center for Family Medicine, Sioux Falls, South Dakota.'}]",South Dakota medicine : the journal of the South Dakota State Medical Association,[]
2063,35708562,The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises on Dyspnea and Fatigue Symptoms of COPD Patients: A Randomized Controlled Study.,"This study was conducted to examine the effect of progressive muscle relaxation and deep breathing exercises applied to patients diagnosed with chronic obstructive pulmonary disease (COPD) on their dyspnea and fatigue symptoms. The study was a randomized controlled experimental trial and comprised 116 COPD patients who applied to a chest diseases follow-up outpatient clinic hospital located in Gaziantep, Turkey. The data were collected using the ""Patient Information Form"" including sociodemographic and disease-related characteristics of the patients, COPD and Asthma Fatigue Scale (CAFS), and Dyspnea-12 Scale. Dyspnea-12 Scale and CAFS total scores of the patients in the intervention group showed a statistically significant difference before and after the Progressive Relaxation Exercise and Deep Breathing Exercise applications (P < .05). Although the Dyspnea-12 Scale and CAFS total mean scores showed an increase in the intervention group, they remained the same in the control group. In the present study, it was found that the Progressive Muscle Relaxation Exercise and Deep Breathing Exercise applied to COPD patients were effective in decreasing their dyspnea and fatigue symptoms.",2022,"Although the Dyspnea-12 Scale and CAFS total mean scores showed an increase in the intervention group, they remained the same in the control group.","['116 COPD patients who applied to a chest diseases follow-up outpatient clinic hospital located in Gaziantep, Turkey', 'COPD Patients', 'patients diagnosed with chronic obstructive pulmonary disease (COPD) on their dyspnea and fatigue symptoms']","['Progressive Muscle Relaxation and Deep Breathing Exercises', 'progressive muscle relaxation and deep breathing exercises', 'Progressive Muscle Relaxation Exercise and Deep Breathing Exercise']","['Dyspnea and Fatigue Symptoms', 'Progressive Relaxation Exercise and Deep Breathing Exercise applications', 'COPD and Asthma Fatigue Scale (CAFS), and Dyspnea-12 Scale. Dyspnea-12 Scale and CAFS total scores', 'dyspnea and fatigue symptoms', 'Dyspnea-12 Scale and CAFS total mean scores']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0454496', 'cui_str': 'Deep breathing exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454496', 'cui_str': 'Deep breathing exercises'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",116.0,0.0201487,"Although the Dyspnea-12 Scale and CAFS total mean scores showed an increase in the intervention group, they remained the same in the control group.","[{'ForeName': 'Adile', 'Initials': 'A', 'LastName': 'Neşe', 'Affiliation': 'Gaziantep University Vocational School of Health Services, Gaziantep, Turkey (Dr Neşe); and Faculty of Health Sciences, Nursing Department, Muğla Sıtkı Kocaman University, Muğla, Turkey (Dr Samancıoğlu Bağlama).'}, {'ForeName': 'Sevgin', 'Initials': 'S', 'LastName': 'Samancıoğlu Bağlama', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000531']
2064,35708559,The Effect of Acupressure on Sleep Quality of Older People in Australian Residential Aged Care Facilities: A Pilot Randomized Controlled Trial.,"This study investigated the effects of acupressure on sleep quality, anxiety, depression, and quality of life among older people in Australia. Acupressure improved overall subjective sleep quality and anxiety but no differences in depression and quality of life. Future studies with larger sample sizes are required to generate good evidence.",2022,Acupressure improved overall subjective sleep quality and anxiety but no differences in depression and quality of life.,"['Older People in Australian Residential Aged Care Facilities', 'older people in Australia']","['acupressure', 'Acupressure']","['sleep quality, anxiety, depression, and quality of life', 'depression and quality of life', 'overall subjective sleep quality and anxiety', 'Sleep Quality']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",,0.104936,Acupressure improved overall subjective sleep quality and anxiety but no differences in depression and quality of life.,"[{'ForeName': 'Nant Thin Thin', 'Initials': 'NTT', 'LastName': 'Hmwe', 'Affiliation': 'School of Nursing and Midwifery, The University of Newcastle, Newcastle, New South Wales, Australia (Drs Hmwe, Browne, and Mollart); Maroba Caring Communities, Waratah, New South Wales, Australia (Ms Allanson); and Tung Wah College, Hong Kong (Dr Chan).'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Browne', 'Affiliation': ''}, {'ForeName': 'Lyndall', 'Initials': 'L', 'LastName': 'Mollart', 'Affiliation': ''}, {'ForeName': 'Viv', 'Initials': 'V', 'LastName': 'Allanson', 'Affiliation': ''}, {'ForeName': 'Sally Wai-Chi', 'Initials': 'SW', 'LastName': 'Chan', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000529']
2065,35708557,The Effect of Aromatherapy on Blood Pressure and Stress Responses by Inhalation and Foot Massage in Patients With Essential Hypertension: Randomized Clinical Trial.,"A 3-arm, parallel group, randomized clinical trial examines the effect of aromatherapy through inhalation and foot massage on blood pressure and stress response in patients with essential hypertension. Lavender oil reduced blood pressure, heart rate, serum cortisol, and subjective anxiety in hypertensive patients.",2022,"Lavender oil reduced blood pressure, heart rate, serum cortisol, and subjective anxiety in hypertensive patients.","['Patients With Essential Hypertension', 'patients with essential hypertension', 'hypertensive patients']","['Aromatherapy', 'Lavender oil', 'Inhalation and Foot Massage', 'aromatherapy through inhalation and foot massage']","['Blood Pressure and Stress Responses', 'blood pressure, heart rate, serum cortisol, and subjective anxiety', 'blood pressure and stress response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0339098,"Lavender oil reduced blood pressure, heart rate, serum cortisol, and subjective anxiety in hypertensive patients.","[{'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Can Çiçek', 'Affiliation': 'Faculty of Health Sciences, Department of Nursing (Drs Can Çiçek and Demir), Internal Medicine Nursing (Dr Demir), Bolu Abant Izzet Baysal University, Bolu, Turkey; Departments of Neurology (Dr Yılmaz), Cardiology (Ms Açıkgöz), and Medical Biochemisty (Dr Yis), Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital, Bolu, Turkey; and Integrative Medicine Association Physical Therapy, Isparta, Turkey (Dr Yıldız).'}, {'ForeName': 'Şeyma', 'Initials': 'Ş', 'LastName': 'Demir', 'Affiliation': ''}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yılmaz', 'Affiliation': ''}, {'ForeName': 'Aynur', 'Initials': 'A', 'LastName': 'Açıkgöz', 'Affiliation': ''}, {'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Yıldız', 'Affiliation': ''}, {'ForeName': 'Özgür Mehmet', 'Initials': 'ÖM', 'LastName': 'Yis', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000526']
2066,35708506,"Pigmentation Control in Pregnancy-Induced Melasma: Clinical Assessment of a Non-hydroquinone, Non-retinol Pigment-Correcting Serum.","BACKGROUND


Melasma is an acquired disorder that results in irregular brown patches on the skin that can occur due to hormonal changes. Although pregnancy-induced melasma is usually temporary, it can become a chronic condition, with significant negative impact on quality of life (QoL).
AIMS


Determine the efficacy and tolerability of a topical, non-hydroquinone, non-retinol pigment-correcting serum (LYT2) for the treatment of pregnancy-induced melasma.
METHODS


This 12-week, single-center clinical trial enrolled 34 non-pregnant women who developed mild to severe facial melasma following a previous pregnancy (mean age, 42 years). LYT2 was applied twice daily to facial skin for 12 weeks in addition to a basic skincare regimen. Outcomes included changes from baseline in skin physiology parameters, such as brightness (L*) using objective digital image analysis, investigator-rated Overall Hyperpigmentation scale, Global Improvement, and Melasma Area and Severity Index (MASI), as well as subject-assessed Melasma Quality of Life Scale. Subjects also completed a questionnaire on self-perceived efficacy and attributes of the study product. Tolerability was assessed by the investigators (erythema, scaling, and edema) and subjects (burning/stinging and itching). Clinical assessments were conducted at baseline and weeks 4, 8, and 12.
RESULTS


LYT2 provided statistically significant reductions in Overall Hyperpigmentation scores as early as week 4 (-5.8% change from baseline) and continued through week 12 (-14.6% change from baseline; all P<.001). Significant improvements in MASI scores and QoL were also achieved following LYT2 treatment, which was well tolerated.
CONCLUSIONS


LYT2 represents a new efficacious alternative to hydroquinone-based treatments for pregnancy-induced melasma.",2022,"Clinical assessments were conducted at baseline and weeks 4, 8, and 12.
RESULTS


LYT2 provided statistically significant reductions in Overall Hyperpigmentation scores as early as week 4 (-5.8% change from baseline) and continued through week 12 (-14.6% change from baseline; all P<.001).","['34 non-pregnant women who developed mild to severe facial melasma following a previous pregnancy (mean age, 42\u2009years', 'pregnancy-induced melasma']","['LYT2', 'topical, non-hydroquinone, non-retinol pigment-correcting serum (LYT2']","['tolerated', 'Overall Hyperpigmentation scores', 'skin physiology parameters, such as brightness (L*) using objective digital image analysis, investigator-rated Overall Hyperpigmentation scale, Global Improvement, and Melasma Area and Severity Index (MASI), as well as subject-assessed Melasma Quality of Life Scale', 'Tolerability', 'investigators (erythema, scaling, and edema) and subjects (burning/stinging and itching', 'MASI scores and QoL', 'efficacy and tolerability', 'quality of life (QoL']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037289', 'cui_str': 'Skin function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0200765', 'cui_str': 'Image analysis'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0677500', 'cui_str': 'Stinging'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",34.0,0.0417655,"Clinical assessments were conducted at baseline and weeks 4, 8, and 12.
RESULTS


LYT2 provided statistically significant reductions in Overall Hyperpigmentation scores as early as week 4 (-5.8% change from baseline) and continued through week 12 (-14.6% change from baseline; all P<.001).","[{'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Makino', 'Affiliation': 'Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Lily I', 'Initials': 'LI', 'LastName': 'Jiang', 'Affiliation': 'SGS Stephens Inc, Richardson, TX, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Stephens', 'Affiliation': 'SGS Stephens Inc, Richardson, TX, USA.'}, {'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Mikati', 'Affiliation': 'Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Rahul C', 'Initials': 'RC', 'LastName': 'Mehta', 'Affiliation': 'Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.15165']
2067,35708481,A randomized controlled trial concerning the implementation of the postural Mézières treatment in elite athletes with low back pain.,"OBJECTIVE


This study aimed to evaluate the impact of adding the Mézières Method (MM) to the standard rehabilitation protocol for the elite athletes with low back pain (LBP) in reducing lumbar pain than only using the traditional rehabilitation protocol treatment. The disciplines considered in this study were soccer, rhythmic gymnastics, and basketball.
DESIGN


Randomized controlled trial.
SETTING


Training Camp.
PARTICIPANTS


One hundred thirty-nine elite athletes with low back pain of whom 69 were assigned to the experimental group.
INTERVENTION


The intervention consists of treatment with three lying postures in a 40-minutes long session twice a week. The session goal was to focus on breathing exercises, spine mobility, and stretching of the back muscles, with particular attention to the diaphragmatic, paravertebral, and latissimus dorsi muscles.
OUTCOME MEASURES


Assessments as Visual Analogue Scale (VAS), Sit and Reach flexibility test, Roland-Morris Questionnaire, and health status questionnaire (SF12) were used.
RESULTS


The evaluation of all outcomes in 4 measurement periods of the study (baseline, 4, 12, and 24 weeks) showed a significant difference between groups. Also, at the 6-month of the intervention, a significant difference in the means (SD) was observed in pain (VAS), back flexibility (Sit & Reach) and back disability (QRM) outcomes in favor of the experimental group with a medium-large effect size comparing with the control group.
CONCLUSION


The MM approach can also be applied in established conventional protocols to alleviate pain and functionality. The obtained results include improving the quality of life of the athletes and their physical and emotional states.
Clinical trial registration number ID :  NCT03849053.",2022,"Also, at the 6-month of the intervention, a significant difference in the means (SD) was observed in pain (VAS), back flexibility (Sit & Reach) and back disability (QRM) outcomes in favor of the experimental group with a medium-large effect size comparing with the control group.
","['Training Camp', 'elite athletes with low back pain', 'One hundred thirty-nine elite athletes with low back pain of whom 69 were assigned to the experimental group', 'elite athletes with low back pain (LBP']","['Mézières Method (MM', 'postural Mézières treatment']","['pain (VAS), back flexibility (Sit & Reach) and back disability (QRM) outcomes', 'Visual Analogue Scale (VAS), Sit and Reach flexibility test, Roland-Morris Questionnaire, and health status questionnaire (SF12', 'quality of life of the athletes and their physical and emotional states', 'lumbar pain']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",139.0,0.0557626,"Also, at the 6-month of the intervention, a significant difference in the means (SD) was observed in pain (VAS), back flexibility (Sit & Reach) and back disability (QRM) outcomes in favor of the experimental group with a medium-large effect size comparing with the control group.
","[{'ForeName': 'Orges', 'Initials': 'O', 'LastName': 'Lena', 'Affiliation': 'Health Sciences Department, Universidad Catolica de Murcia UCAM, Spain.'}, {'ForeName': 'Jasemin', 'Initials': 'J', 'LastName': 'Todri', 'Affiliation': 'Health Sciences Department, Universidad Catolica de Murcia UCAM, Spain.'}, {'ForeName': 'Ardita', 'Initials': 'A', 'LastName': 'Todri', 'Affiliation': 'Statistics Specialist Area. Economics Department, Universiteti ""Aleksander Xhuvani"", Elbasan, Albania.'}, {'ForeName': 'Petraq', 'Initials': 'P', 'LastName': 'Papajorgji', 'Affiliation': 'Informatics Department, European University of Tirana, Albania.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Martínez-Fuentes', 'Affiliation': 'Health Sciences Department, Universidad Catolica de Murcia UCAM, Spain.'}]",Postgraduate medicine,['10.1080/00325481.2022.2089464']
2068,35708471,"Predictors of adherence, contamination and dropout in home-based walking by lung and oesophageal cancer patients from two randomised control trials: An exploratory study.","OBJECTIVES


In this study, we examined predictors of exercise adherence, contamination and dropout in lung and oesophageal cancer patients who participated in two randomised controlled trials.
METHODS


We used data on 188 lung and oesophageal cancer patients from two previous studies (intervention: moderate-intensity walking for 12 weeks). Baseline measurements included demographic variables, disease characteristics, Hospital Anxiety and Depression Scale and Bouchard 3-day physical activity (PA) record. We used multiple linear and logistic regressions to analyse predictors of exercise adherence in the walking group, contamination in the control group and dropout in both groups.
RESULTS


Pre-intervention exercise habits and baseline depression scores predicted adherence, with an explanatory power of 16.7% (p < 0.0001). Pre-intervention exercise habits (odds ratio [OR] 19.65, 95% confidence interval [CI] 2.76-139.97), baseline moderate PA (min/day) (OR 1.03, 95% CI 1.01-1.05) and baseline vigorous PA (min/day) (OR 1.09, 95% CI 1.01-1.18) predicted contamination. Baseline mild PA (10 min/day) (OR 0.94, 95% CI 0.89-0.99) predicted dropout.
CONCLUSIONS


Pre-intervention exercise habits and baseline depression levels predicted exercise adherence in the walking group. In the control group, pre-intervention exercise habits and baseline moderate and vigorous PA predicted contamination. Baseline mild PA predicted dropout rates in both groups.",2022,"Baseline mild PA (10 min/day) (OR 0.94, 95% CI 0.89-0.99) predicted dropout.
","['188 lung and oesophageal cancer patients from two previous studies (intervention: moderate-intensity walking for 12\u2009weeks', 'home-based walking by lung and oesophageal cancer patients', 'lung and oesophageal cancer patients who participated in two randomised controlled trials']",['Pre-intervention exercise habits (odds ratio [OR'],"['adherence, contamination and dropout', 'exercise adherence, contamination and dropout', 'demographic variables, disease characteristics, Hospital Anxiety and Depression Scale and Bouchard 3-day physical activity (PA) record', 'Baseline mild PA', 'baseline vigorous PA']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",,0.113484,"Baseline mild PA (10 min/day) (OR 0.94, 95% CI 0.89-0.99) predicted dropout.
","[{'ForeName': 'Hui-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, College of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, College of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chung', 'Initials': 'YC', 'LastName': 'Wu', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chien-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Po-Kuei', 'Initials': 'PK', 'LastName': 'Hsu', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ling-I', 'Initials': 'LI', 'LastName': 'Chien', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jiu-Yun', 'Initials': 'JY', 'LastName': 'Tian', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Linh Thuy', 'Initials': 'LT', 'LastName': 'Duong', 'Affiliation': 'Faculty of Nursing and Midwifery, Hanoi Medical University, Hanoi, Vietnam.'}]",European journal of cancer care,['10.1111/ecc.13635']
2069,35708447,Strategies to decrease morbidity in surgical management of esophageal cancer: a single center experience.,"BACKGROUND


We herein present our experience to decrease morbidity by performing a few changes during and after the Ivor Lewis esophagectomy.
METHODS


This is a retrospective single center experience comparing a control period (group A) and a study period (group B) in patients who underwent esophagectomy for esophageal cancer (control group: 23; study group: 17). -Control group: postero-lateral thoracotomy and a gastric tube without aspiration during postoperative period. -Study group: limited lateral muscle sparing thoracotomy and postoperatively the gastric tube was routinely left for 1 week with intermittent aspiration (10 times every two hours for 1 week).
RESULTS


Average operation time was 312±56 minutes in control period, in study period 189±36 min. Average ICU stay was 10 (7-32) days in the control group, in study group 4 (1-8) days. Anastomotic leak rate was significantly higher in control vs study group (53,3% vs 16,6%; p<0,05). Respiratory complications were significantly lower in the study group (47,8% vs 17,6%).
CONCLUSIONS


The combination of a limited lateral thoracotomy and postoperative intermittent aspiration seem to reduce the rate of respiratory and anastomotic complication after Ivor-Lewis procedure.",2022,"Anastomotic leak rate was significantly higher in control vs study group (53,3% vs 16,6%; p<0,05).","['esophageal cancer', 'patients who underwent esophagectomy for esophageal cancer (control group: 23; study group: 17']","['limited lateral thoracotomy and postoperative intermittent aspiration', 'postero-lateral thoracotomy and a gastric tube without aspiration', 'Study group: limited lateral muscle sparing thoracotomy', 'Control']","['morbidity', 'Respiratory complications', 'rate of respiratory and anastomotic complication', 'Average ICU stay', 'Anastomotic leak rate']","[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0442951', 'cui_str': 'Posterolateral thoracotomy'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C1141928', 'cui_str': 'Anastomotic complication'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}]",,0.0252991,"Anastomotic leak rate was significantly higher in control vs study group (53,3% vs 16,6%; p<0,05).","[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Rizzuto', 'Affiliation': 'Department of Medical and Surgical Science, University Magna Græcia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Amaddeo', 'Affiliation': 'Department of Medical and Surgical Science, University Magna Græcia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bozzarello', 'Affiliation': 'Department of Medical and Surgical Science, University Magna Græcia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Currò', 'Affiliation': 'Department of Medical and Surgical Science, University Magna Græcia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Feurstein', 'Affiliation': 'Department of General, Visceral and Thoracic Surgery, Landeskrankenhaus Feldkirch, Feldkirch, Austria.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'DI Stefano', 'Affiliation': 'Department of General, Visceral and Thoracic Surgery, Landeskrankenhaus Feldkirch, Feldkirch, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tschann', 'Affiliation': 'Department of General, Visceral and Thoracic Surgery, Landeskrankenhaus Feldkirch, Feldkirch, Austria.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Konigsrainer', 'Affiliation': 'Department of General, Visceral and Thoracic Surgery, Landeskrankenhaus Feldkirch, Feldkirch, Austria.'}, {'ForeName': 'Paolo N', 'Initials': 'PN', 'LastName': 'Girotti', 'Affiliation': 'Department of General, Visceral and Thoracic Surgery, Landeskrankenhaus Feldkirch, Feldkirch, Austria - paolo.girotti@vlkh.net.'}]",Minerva surgery,['10.23736/S2724-5691.22.09627-7']
2070,35708431,Effect of different irrigation activation methods on non-infected dentinal tubule penetration of medicaments: A CLSM study.,"Background


The whole root canal disinfection is crucial in terms of long-term endodontic success. In this context, applying medicaments following effective irrigation activation procedures becomes an important point.
Aims


The purpose of this study was to evaluate and compare the efficacy of various irrigation activation techniques on non-infected dentinal tubule penetration of calcium hydroxide (CH), double (DAP), and triple (TAP) antibiotic pastes.
Materials and Methods


A total of 180 extracted human permanent mandibular premolar single-rooted teeth were selected and randomly divided into a control group and four main groups according to the irrigation activation procedures (n = 36) as KTP laser irradiation, conventional needle, NaviTip FX, sonic (SI) and ultrasonic activation (UI) procedures. Each group was randomly subdivided into three subgroups according to the medicament type (n = 12); CH, DAP, and TAP. After the activation procedures, the root canals were filled with CH, TAP, and DAP mixed with 0.1% fluorescent rhodamine B isothiocyanate. Specimens were sectioned at 2, 5, and 8 mm from the apex, and all the sections were examined under a confocal laser scanning microscope to calculate the dentinal tubule penetration. Data were analyzed using a three-way analysis of variance and Tukey's post hoc tests (P = 0.05).
Results


TAP provided a statistically significant greater penetration than the other groups (P < 0.05). UI provided a statistically significant higher dentinal tubules penetration area than other activation procedures (P < 0.05).
Conclusion


Medicament penetration depends on the type of medicament, activation procedures, and root canal level. The TAP may be preferred following the ultrasonic activation in terms of long term root canal treatment success.",2022,"UI provided a statistically significant higher dentinal tubules penetration area than other activation procedures (P < 0.05).
","['non-infected dentinal tubule penetration of medicaments', '180 extracted human permanent mandibular premolar single-rooted teeth']","['CH, DAP, and TAP', 'TAP', 'calcium hydroxide (CH), double (DAP), and triple (TAP) antibiotic pastes', 'irrigation activation methods', 'irrigation activation procedures', 'KTP laser irradiation, conventional needle, NaviTip FX, sonic (SI) and ultrasonic activation (UI) procedures']",['dentinal tubules penetration area'],"[{'cui': 'C0521118', 'cui_str': 'Non-infected'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0456386', 'cui_str': 'Medicament'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0392222', 'cui_str': 'Potassium titanyl phosphate laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",180.0,0.0548166,"UI provided a statistically significant higher dentinal tubules penetration area than other activation procedures (P < 0.05).
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Sivas Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Topcuoglu', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hubbezoglu', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Sivas Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Gorler', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Dokuz Eylül University, İzmir, Turkey.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Altunbas', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Sivas Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ayhan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Sivas Cumhuriyet University, Sivas, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_1932_21']
2071,35708422,Impact of the individual counseling program for polycystic ovarya syndrome management among university students: A prospective randomized controlled trial.,"Background


Polycystic ovary syndrome (PCOS) is common in women of reproductive age.
Aim


This study aimed to investigate the impact of individual counseling program which had been designed from the transtheoretical model (TM) for students diagnosed with PCOS.
Patients and Methods


The study is a prospective randomized controlled trial. The research was carried out in four stages as screening, diagnosis, randomization, selection, and counseling. The data for the analysis were drawn from a sample of 854 students at first and a total of 67 students were administered the scales. The control (n = 33) and experimental groups (n = 34) were formed based on the simple randomization technique. The sample characteristics were voluntary participation, absence of sexual activity for a minimum of 6 months, belonging to the age group of 19-24, an absence of chronic diseases or any physical disability, and a lack of mental disorders. Participants using medication and obtaining scores of above/below 18.5 and below/above 30 on the body mass index (BMI) were not included in the study.
Results


The prevalence of PCOS among university students was found to be 8.8%. The findings indicated that the majority of the students have been experiencing various physical symptoms such as being overweight, menstrual irregularity, hirsutism, alopecia, acne, and psychological symptoms such as uneasiness, irritability, anger, anxiety, and fatigue. Based on the pretest and posttest scores, it was observed that the anthropometric values and psychological indicators such as the feeling of uneasiness, irritability, anger, anxiety, and fatigue were significantly decreased in the group of PCOS that took the counseling program.
Conclusions


Individual counseling improved the anthropometric measurements and the clinical findings related to PCOS.",2022,"Participants using medication and obtaining scores of above/below 18.5 and below/above 30 on the body mass index (BMI) were not included in the study.
","['women of reproductive age', 'Participants using medication and obtaining scores of above/below 18.5 and below/above 30 on the body mass index (BMI) were not included in the study', 'polycystic ovarya syndrome management among university students', '854 students at first and a total of 67 students', 'age group of 19-24, an absence of chronic diseases or any physical disability, and a lack of mental disorders', 'students diagnosed with PCOS']",['individual counseling program'],"['anthropometric values and psychological indicators such as the feeling of uneasiness, irritability, anger, anxiety, and fatigue', 'prevalence of PCOS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]",34.0,0.0284578,"Participants using medication and obtaining scores of above/below 18.5 and below/above 30 on the body mass index (BMI) were not included in the study.
","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dilek', 'Affiliation': 'Midwifery Department, Faculty of Health Sciences, Tokat Gaziosmapaşa University, Tokat, Turkey.'}, {'ForeName': 'U A', 'Initials': 'UA', 'LastName': 'Senay', 'Affiliation': ""Department of Women's Health and Diseases Nursing, Ege University, Faculty of Nursing, İzmir, Turkey.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fatih', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Health Sciences of Afyonkarahisar University, Afyon, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_1728_21']
2072,35708895,Development and Validation of a Diagnostic Nomogram to Predict the Anthracycline-Induced Early Cardiotoxicity in Children with Hematological Tumors.,"This study aimed to establish and validate an effective nomogram to predict the risk of cardiotoxicity in children after each anthracycline treatment. According to the inclusion and exclusion criteria, the eligible children were randomly divided into the training cohort (75%) and the validation cohort (25%). Least absolute shrinkage and selection operator (LASSO) regression was used to select the predictors and a nomogram was developed. Then, concordance index (C-index), the area under the curve (AUC), Hosmer-Lemeshow (H-L) test, and decision curve analysis (DCA) were employed to evaluate the performance and clinical utility of nomogram. Internal validation was processed to inspect the stability of the model. A total of 796 eligible children were included in this study and divided into a training set (n = 597) and a validation set (n = 199). LASSO regression analysis revealed that cumulative anthracycline dose, ejection fractions, NT-proBNP, and diastolic dysfunction were effective predictors of cardiotoxicity. The nomogram was established based on these variables. The C-index and the AUC of the predicting nomogram were 0.818 in the training cohort and 0.773 in the validation cohort, suggesting that the nomogram had good discrimination. The calibration curve of the nomogram presented no significant deviation from the reference line, and the P-value of the H-L test was 0.283, implying a preferable degree of calibration. The threshold of DCA also reflects that the nomogram is clinically useful. A nomogram was developed to predict anthracycline chemotherapy-induced cardiotoxicity in children with hematological tumors. The nomogram has a good prediction effect and can provide a reference for clinicians' diagnosis and treatment.",2022,"The calibration curve of the nomogram presented no significant deviation from the reference line, and the P-value of the H-L test was 0.283, implying a preferable degree of calibration.","['796 eligible children', 'children with hematological tumors', 'children after each anthracycline treatment', 'Children with Hematological Tumors']","['anthracycline chemotherapy-induced cardiotoxicity', 'Anthracycline-Induced Early Cardiotoxicity']","['concordance index (C-index), the area under the curve (AUC), Hosmer-Lemeshow (H-L) test, and decision curve analysis (DCA', 'cumulative anthracycline dose, ejection fractions, NT-proBNP, and diastolic dysfunction', 'Least absolute shrinkage and selection operator (LASSO) regression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}]",796.0,0.0154051,"The calibration curve of the nomogram presented no significant deviation from the reference line, and the P-value of the H-L test was 0.283, implying a preferable degree of calibration.","[{'ForeName': 'Zhi-Yuan', 'Initials': 'ZY', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Anhui Provincial Children's Hospital, Hefei, Anhui, China.""}, {'ForeName': 'Yun-Gong', 'Initials': 'YG', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Anhui Provincial Children's Hospital, Hefei, Anhui, China.""}, {'ForeName': 'Xiao-Bi', 'Initials': 'XB', 'LastName': 'Huang', 'Affiliation': ""Department of Cardiology, Anhui Provincial Children's Hospital, Hefei, Anhui, China.""}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Qi', 'Affiliation': ""Department of Cardiology, Anhui Provincial Children's Hospital, Hefei, Anhui, China.""}, {'ForeName': 'Cui-Ping', 'Initials': 'CP', 'LastName': 'Qian', 'Affiliation': ""Department of Cardiology, Anhui Provincial Children's Hospital, Hefei, Anhui, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiology, Anhui Provincial Children's Hospital, Hefei, Anhui, China. xxzs312@163.com.""}]",Cardiovascular toxicology,['10.1007/s12012-022-09755-5']
2073,35708892,"A Pilot Study to Assess Glucose, Insulin, and Incretin Responses Following Novel High Resistant Starch Rice Ingestion in Healthy Men.","INTRODUCTION


A newly developed resistant starch (RS) rice line with double mutation of starch synthase IIIa and branching enzyme IIb (ss3a/be2b) exhibits a tenfold greater percentage RS value than the wild-type rice line. Currently, the effects of cooked rice with such high RS content on secretion and action of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are unclear. Therefore, we conducted a pilot study to assess postprandial responses of GLP-1 and GIP along with glucose and insulin and also gastric emptying after ingestion of the high-RS cooked rice with ss3a/be2b in healthy subjects.
METHODS


In a non-randomized crossover design, five healthy men ingested two test foods, control (low-RS) and high-RS cooked rice, with at least 1-week washout period between testing days. Plasma glucose, serum insulin, plasma total GLP-1, plasma total GIP, and also gastric emptying rate were measured after ingestion of each test food, and the incremental area under the curves (iAUC) was calculated for each biochemical parameter using the values from 0 to 180 min after ingestion.
RESULTS


The high-RS cooked rice ingestion tended to reduce iAUC-glucose (p = 0.06) and significantly reduced iAUC-insulin (p < 0.01) and iAUC-GLP-1 (p < 0.05) but not iAUC-GIP (p = 0.21) relative to control cooked rice ingestion. In addition, the high-RS cooked rice ingestion did not affect gastric emptying.
CONCLUSIONS


The present results indicate that the suppressive effects of the high-RS cooked rice ingestion on postprandial responses of glucose and insulin may be provided through attenuation in GLP-1 secretion along with its low digestibility into glucose. We suggest that the high-RS rice with ss3a/be2b may serve as a better carbohydrate source and also as a novel functional food for dietary interventions to improve postprandial hyperglycemia and hyperinsulinemia without both enhancing GLP-1 secretion and affecting gastric emptying in patients with diabetes.",2022,"Plasma glucose, serum insulin, plasma total GLP-1, plasma total GIP, and also gastric emptying rate were measured after ingestion of each test food, and the incremental area under the curves (iAUC) was calculated for each biochemical parameter using the values from 0 to 180 min after ingestion.
","['patients\xa0with diabetes', 'Healthy Men', 'five healthy men', 'healthy subjects']","['resistant starch (RS) rice line with double mutation of starch synthase IIIa and branching enzyme IIb', 'Novel High Resistant Starch Rice Ingestion', 'high-RS cooked rice ingestion']","['iAUC-glucose', 'incremental area under the curves (iAUC', 'Glucose, Insulin, and Incretin Responses', 'iAUC-insulin', 'Plasma glucose, serum insulin, plasma total GLP-1, plasma total GIP, and also gastric emptying rate', 'iAUC-GLP-1', 'gastric emptying']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0038180', 'cui_str': 'Starch (bacterial glycogen) synthase'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0255933', 'cui_str': 'phosphoenolpyruvate-cellobiose phosphotransferase'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}]",5.0,0.0130901,"Plasma glucose, serum insulin, plasma total GLP-1, plasma total GIP, and also gastric emptying rate were measured after ingestion of each test food, and the incremental area under the curves (iAUC) was calculated for each biochemical parameter using the values from 0 to 180 min after ingestion.
","[{'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan. hirofuji@gipc.akita-u.ac.jp.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Fujita', 'Affiliation': 'Laboratory of Plant Physiology, Department of Biological Production, Faculty of Bioresource Sciences, Akita Prefectural University, Akita, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Suganuma', 'Affiliation': 'Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Waki', 'Affiliation': 'Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-022-01283-3']
2074,35708885,Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial.,"INTRODUCTION


This study aims to investigate pharmacokinetics (PK) and exposure-response parameters of the 400 mg once-daily venetoclax dose regimen in combination with obinutuzumab, which was approved for the first-line (1L) treatment of chronic lymphocytic leukemia (CLL) based on data from the phase 3 CLL14 study and the phase 1b dose-finding GP28331 study.
METHODS


Parameter estimates and uncertainty, which were estimated by a previously developed population PK (popPK) model, were used as informative priors for this analysis. They were re-estimated, and then used to evaluate additional covariate effects, describe venetoclax PK when administered with obinutuzumab, and provide empirical Bayes estimates of PK parameters and exposure. Exposure-progression-free survival (PFS) and exposure-safety relationships were assessed using data from CLL14, with steady-state nominal venetoclax exposure (C meanSS,nominal ) as the predictor variable. Exposure-safety analyses were conducted using logistic regression for selected treatment-emergent grade ≥ 3 adverse events (AEs) and serious AEs (SAEs). Dose intensities were summarized by tertiles of C meanSS,nominal .
RESULTS


PK data from 274 patients (CLL14, n = 194; GP28331, n = 80) were included. The final model provided good fit of the observed data. Obinutuzumab co-administration, history of prior treatments, and disease severity at baseline had no appreciable influence on venetoclax steady-state exposure. No significant correlations were observed between venetoclax exposure and PFS, or between venetoclax exposure and the probability of treatment-emergent grade ≥ 3 neutropenia, grade ≥ 3 thrombocytopenia, grade ≥ 3 infections, and SAEs. Median dose intensities for venetoclax and obinutuzumab remained similar across venetoclax exposure tertiles.
CONCLUSION


PopPK and exposure-efficacy, exposure-safety, and exposure-tolerability analyses support the 400 mg once-daily venetoclax dose plus obinutuzumab for 1L treatment in patients with CLL.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifiers NCT02242942 and NCT02339181.",2022,"Median dose intensities for venetoclax and obinutuzumab remained similar across venetoclax exposure tertiles.
","['chronic lymphocytic leukemia (CLL) based on\xa0data from the phase\xa03 CLL14 study and the phase\xa01b dose-finding GP28331 study', '274 patients (CLL14, n\u2009=\u2009194; GP28331, n\u2009=\u200980) were included', 'Chronic Lymphocytic Leukemia', 'patients with CLL']",['Venetoclax\u2009+\u2009Obinutuzumab'],"['PopPK and exposure-efficacy, exposure-safety, and exposure-tolerability', 'adverse events (AEs) and serious AEs (SAEs', 'venetoclax steady-state exposure', 'Exposure-progression-free survival (PFS) and exposure-safety relationships', 'venetoclax exposure and PFS, or between venetoclax exposure and the probability of treatment-emergent grade\u2009≥\u20093 neutropenia, grade\u2009≥\u20093 thrombocytopenia, grade\u2009≥\u20093 infections, and SAEs']","[{'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.16857,"Median dose intensities for venetoclax and obinutuzumab remained similar across venetoclax exposure tertiles.
","[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Samineni', 'Affiliation': 'Genentech, Inc., 1 DNA Way, South San Francisco, CA, USA. samineni.divya@gene.com.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Gibiansky', 'Affiliation': 'QuantPharm LLC, North Potomac, MD, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Genentech, Inc., 1 DNA Way, South San Francisco, CA, USA.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Vadhavkar', 'Affiliation': 'Genentech, Inc., 1 DNA Way, South San Francisco, CA, USA.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Rajwanshi', 'Affiliation': 'VRAY Pharma Consulting, Cupertino, CA, USA.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Tandon', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ahmed Hamed', 'Initials': 'AH', 'LastName': 'Salem', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Chunze', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Genentech, Inc., 1 DNA Way, South San Francisco, CA, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Genentech, Inc., 1 DNA Way, South San Francisco, CA, USA.'}]",Advances in therapy,['10.1007/s12325-022-02170-w']
2075,35708865,Effect of IL-10 in the pathogenesis of HIV/AIDS patients with cryptococcal meningitis.,"This study aimed to explore the role of IL-10 in the pathogenesis of HIV/AIDS patients with cryptococcal meningitis (CM).Patients were assigned into 4 groups (n = 40/group): group A (HIV/AIDS with CM), group B (HIV/AIDS with tuberculosis), group C (HIV/AIDS), and group D (CM). The levels of IL-10 and associated indicators were measured and the correlations were analyzed by Pearson correlation and partial correlation method. In plasma and cerebrospinal fluid (CSF), no significant difference was observed on IL-10 level between group A and other groups (P > 0.050). R values for IL-10 and relevant indicators in blood were as follows (P < 0.050): group A, IFN-γ (-0.377), IL-12 (0.743), IL-4 (0.881), and IL-6 (0.843); group B, IL-12 (0.740), IL-4 (0.573), and IL-6 (0.900); group C, IL-12 (0.402) and IL-4 (0.896); group D, IL-12 (0.575), IL-4 (0.852), and CD8 (0.325). R values for IL-10 and related indicators in CSF were as follows (P < 0.050): group A, TNF-α (0.664), IL-4 (0.852), white blood cells (WBCs, 0.321) and total protein (TP, 0.330); group B, TNF-α (0.566), IL-4 (0.702), and lactate dehydrogenase (LDH, 0.382); group D, IFN-γ (0.807) and IL-4 (0.441). IL-10 level was positively correlated with IL-4, IL-6, IL-12, TNF-α, WBC, and TP in blood or CSF, and negatively correlated with IFN-γ in blood, suggesting that IL-10 affected both pro-inflammatory and anti-inflammatory activities in the pathogenesis of HIV/AIDS with CM.",2022,"IL-10 level was positively correlated with IL-4, IL-6, IL-12, TNF-α, WBC, and TP in blood or CSF, and negatively correlated with IFN-γ in blood, suggesting that IL-10 affected both pro-inflammatory and anti-inflammatory activities in the pathogenesis of HIV/AIDS with CM.","['HIV/AIDS patients with cryptococcal meningitis (CM).Patients', 'HIV/AIDS patients with cryptococcal meningitis']","['IL-10', 'TNF-α']","['IL-4 (0.852), white blood cells (WBCs, 0.321) and total protein (TP, 0.330); group B, TNF-α (0.566), IL-4 (0.702), and lactate dehydrogenase (LDH, 0.382); group D, IFN-γ (0.807) and IL-4', 'plasma and cerebrospinal fluid (CSF', 'IL-10 level', 'IL-4, IL-6, IL-12, TNF-α, WBC, and TP in blood or CSF', 'levels of IL-10 and associated indicators']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085436', 'cui_str': 'Cryptococcal meningitis'}, {'cui': 'C0010415', 'cui_str': 'Cryptococcus'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.19371,"IL-10 level was positively correlated with IL-4, IL-6, IL-12, TNF-α, WBC, and TP in blood or CSF, and negatively correlated with IFN-γ in blood, suggesting that IL-10 affected both pro-inflammatory and anti-inflammatory activities in the pathogenesis of HIV/AIDS with CM.","[{'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Mo', 'Affiliation': ""Department of Laboratory Medicine, Nanning Fourth People's Hospital, Guangxi AIDS Clinical Treatment Center (Nanning), Nanning Infectious Disease Hospital Affiliated to Guangxi Medical University, Nanning, 530023, China.""}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Su', 'Affiliation': 'Department of Laboratory Medicine, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Hanzhen', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': ""Department of Laboratory Medicine, Nanning Fourth People's Hospital, Guangxi AIDS Clinical Treatment Center (Nanning), Nanning Infectious Disease Hospital Affiliated to Guangxi Medical University, Nanning, 530023, China.""}, {'ForeName': 'Wanhong', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Laboratory Medicine, Nanning Fourth People's Hospital, Guangxi AIDS Clinical Treatment Center (Nanning), Nanning Infectious Disease Hospital Affiliated to Guangxi Medical University, Nanning, 530023, China.""}, {'ForeName': 'Xiaolu', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': ""Department of Laboratory Medicine, Nanning Fourth People's Hospital, Guangxi AIDS Clinical Treatment Center (Nanning), Nanning Infectious Disease Hospital Affiliated to Guangxi Medical University, Nanning, 530023, China. xiaoluluo@yeah.net.""}, {'ForeName': 'Chuanmin', 'Initials': 'C', 'LastName': 'Tao', 'Affiliation': 'Department of Laboratory Medicine, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, Sichuan, China. taochuanmin@sina.com.'}]",Molecular and cellular biochemistry,['10.1007/s11010-022-04488-z']
2076,35708845,Kidney function deterioration is dependent on blood pressure levels: 11.2 year follow-up in diabetic patients.,"There is little evidence of how blood pressure level over 10 years affects the decline of estimated glomerular filtration rate (eGFR) in diabetic patients. The Japanese primary prevention of atherosclerosis with aspirin for diabetes (JPAD) trial was a multicenter, randomized, clinical trial done from 2002 to 2008. After completion of the JPAD trial, we followed up the patients until 2019 as a cohort study. We defined late-stage kidney disease (LSKD) as eGFR < 30 ml/min/1.73 m 2  or hemodialysis. Based on the mean value of systolic blood pressure (SBP) obtained average 7 times during the follow-up, we divided the patients into three groups: a high SBP group (n = 607, SBP ≥ 140 mm Hg); a moderate SBP group (n = 989, 140 > SBP ≥ 130 mm Hg); or a low SBP group (n = 913, SBP < 130 mm Hg). There was no significant deference in the mean eGFR among the high SBP, moderate SBP and low SBP groups on registration. The incidence rate of LSKD was significantly higher in the high SBP (HR 2.02, 95% CI 1.36-3.01) and moderate SBP (HR 1.54, 95% CI 1.07-2.20) groups than in the low SBP group (Log-Rank P = 0.0018). Cox proportional hazards model analysis revealed that the high SBP (HR, 1.57, P = 0.049) and moderate SBP (HR, 1.52, P = 0.037) were independent factors after adjustment for proteinuria ≥  ± , age ≥ 65 years, men, body mass index ≥ 24 kg/m 2 , duration of diabetes ≥ 7.0 years, statin usage, eGFR ≥ 60 ml/min/1.73 m 2 , hemoglobin A1c ≥ 7.2%, and smoking status. Our 11.2 year follow-up study demonstrated that mean SBP was independently associated with the progression to LSKD in diabetic patients. These findings may become new evidence that SBP less than 130 mm Hg is recommended for diabetic patients to prevent progression to LSKD.",2022,"There was no significant deference in the mean eGFR among the high SBP, moderate SBP and low SBP groups on registration.","['diabetic patients', '24\xa0kg', '65\xa0years, men, body mass index\u2009≥', '2002 to 2008']","['low SBP', 'aspirin']","['glomerular filtration rate (eGFR', 'incidence rate of LSKD', 'moderate SBP', 'duration of diabetes\u2009≥', 'mean eGFR', 'mean SBP', 'mean value of systolic blood pressure (SBP', 'blood pressure levels']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0477953,"There was no significant deference in the mean eGFR among the high SBP, moderate SBP and low SBP groups on registration.","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto, 860-8556, Japan. yuuki@gpo.kumamoto-u.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Sadanori', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Department of Diabetes and Endocrinology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Center for Health Surveillance and Preventive Medicine, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Nakayama Cardiovascular Clinic, Amakusa, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Masuda', 'Affiliation': 'Takeda Hospital Medical Examination Center, Kyoto, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Department of Internal Medicine, Jinnouchi Hospital Diabetes Care Center, Kumamoto, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Food Safety Commission of Japan, Tokyo, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, Kashihara, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Heart and vessels,['10.1007/s00380-022-02085-0']
2077,35708823,Correction to: Study protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults.,,2022,,['pre-frail older adults'],['complex intervention'],[],"[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.149043,,"[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Teh', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, University of Auckland, Auckland, New Zealand. r.teh@auckland.ac.nz.'}, {'ForeName': 'Ngaire', 'Initials': 'N', 'LastName': 'Kerse', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Waters', 'Affiliation': 'Department of Medicine, School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Hale', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Avinesh', 'Initials': 'A', 'LastName': 'Pillai', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Evelingi', 'Initials': 'E', 'LastName': 'Leilua', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Tay', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rolleston', 'Affiliation': 'The Centre of Health, Tauranga, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Edlin', 'Affiliation': 'Health Systems Group, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Eruera', 'Initials': 'E', 'LastName': 'Maxted', 'Affiliation': 'Lakes District Health Board, Rotorua, New Zealand.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Heppenstall', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Connolly', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Auckland, New Zealand.'}]",Aging clinical and experimental research,['10.1007/s40520-022-02162-4']
2078,35708794,Direct Percutaneous Endoscopic Gastrostomy Versus Radiological Gastrostomy in Patients Unable to Undergo Transoral Endoscopic Pull Gastrostomy.,"BACKGROUND AND AIMS


A subset of patients needing long-term enteral access are unable to undergo a conventional transoral ""pull"" percutaneous endoscopic gastrostomy (PEG). We assessed the safety and efficacy of an introducer-style endoscopic direct PEG (DPEG) and an interventional radiologist guided gastrostomy (IRG) among patients unable to undergo a pull PEG.
METHODS


In this single center, non-randomized, pilot study, patients unable to undergo a transoral Pull PEG were prospectively recruited for a DPEG during the index endoscopy. IRG procedures performed at our center served as the comparison group. The primary outcome was technical success and secondary outcomes included 30-day and 90-day all-cause mortality, procedure duration, dosage of medications, adverse events, and 30-day all-cause hospitalization. The Charlson comorbidity index was used to compare comorbidities.
RESULTS


A total of 47 patients (68.3 ± 7.13 years) underwent DPEG and 45 patients (68.6 ± 8.23 years) underwent IRG. The respective Charlson comorbidity scores were 6.37 ± 2 and 6.16 ± 1.72 (P = 0.59). Malignancies of the upper aerodigestive tract were the most common indications for DPEG and IRG (42 vs. 37; P = 0.38). The outcomes for DPEG and IRG were as follows: technical success: 96 vs. 98%; P = 1; 30-day all-cause mortality: 0 vs 15%, P < 0.01; 90-day all-cause mortality: 0 vs. 31%, P < 0.001; 30-day hospitalization: 19 vs. 38%; P = 0.06; procedure duration: 23.8 ± 1.39 vs. 29.5 ± 2.03 min, P = 0.02; midazolam dose: 4.5 ± 1.6 vs. 1.23 ± 0.6 mg; P < 0.001, and opiate dose: 105.6 ± 38.2 vs. 70.7 ± 34.5 µg, P < 0.001, respectively. Perforation of the colon during IRG was the sole serious adverse event.
CONCLUSION


DPEG is a safe and effective alternative to IRG in patients unable to undergo a conventional transoral pull PEG and may be considered as a primary modality for enteral support.
CLINICALTRIALS


gov Identifier: NCT04151030.",2022,"The outcomes for DPEG and IRG were as follows: technical success: 96 vs. 98%; P = 1; 30-day all-cause mortality: 0 vs 15%, P < 0.01; 90-day all-cause mortality: 0 vs. 31%, P ","['Patients Unable to Undergo Transoral Endoscopic Pull Gastrostomy', 'patients unable to undergo a transoral Pull PEG were prospectively recruited for a DPEG during the index endoscopy', 'patients unable to undergo a pull PEG', '47 patients (68.3\u2009±\u20097.13\xa0years) underwent DPEG and 45 patients (68.6\u2009±\u20098.23\xa0years) underwent IRG']","['introducer-style endoscopic direct PEG (DPEG', 'DPEG', 'Direct Percutaneous Endoscopic Gastrostomy Versus Radiological Gastrostomy', 'interventional radiologist guided gastrostomy (IRG', 'conventional transoral ""pull"" percutaneous endoscopic gastrostomy (PEG']","['30-day hospitalization', 'respective Charlson comorbidity scores', 'Charlson comorbidity index', 'technical success and secondary outcomes included 30-day and 90-day all-cause mortality, procedure duration, dosage of medications, adverse events, and 30-day all-cause hospitalization', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0017196', 'cui_str': 'Gastrostomy'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0456642', 'cui_str': 'Introducer'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0017196', 'cui_str': 'Gastrostomy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",47.0,0.0410246,"The outcomes for DPEG and IRG were as follows: technical success: 96 vs. 98%; P = 1; 30-day all-cause mortality: 0 vs 15%, P < 0.01; 90-day all-cause mortality: 0 vs. 31%, P ","[{'ForeName': 'Divyanshoo R', 'Initials': 'DR', 'LastName': 'Kohli', 'Affiliation': 'Division of Gastroenterology and Hepatology, Kansas City VA Medical Center, 4801 E Linwood Blvd, Kansas City, MO, 64128, USA. kohli015@gmail.com.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Division of Interventional Radiology, Kansas City VA Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Chaudhry', 'Affiliation': 'Division of Interventional Radiology, Kansas City VA Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Madhav', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Kansas City VA Medical Center, 4801 E Linwood Blvd, Kansas City, MO, 64128, USA.'}, {'ForeName': 'Dion', 'Initials': 'D', 'LastName': 'DePaolis', 'Affiliation': 'Division of Interventional Radiology, Kansas City VA Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Division of Gastroenterology and Hepatology, Kansas City VA Medical Center, 4801 E Linwood Blvd, Kansas City, MO, 64128, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-022-07569-7']
2079,35708779,Modified coronally advanced tunnel versus epithelialized free gingival graft technique in gingival phenotype modification: a comparative randomized controlled clinical trial.,"OBJECTIVES


The gingival thickness (GT) and keratinized tissue (KT) height are defined as the gingival phenotype. Both the modified coronally advanced tunnel technique (MCAT) and free gingival grafts (FGG) are used in modifying the gingival phenotype. This study aims to compare MCAT and FGG in gingival phenotype modification.
MATERIALS AND METHODS


One hundred and forty recessions in 50 patients with thin and insufficient keratinized tissue at the anterior mandible were treated with either MCAT or FGG. GT, KT height, recession depth, recession width, probing depth, and clinical attachment level were evaluated at baseline and 6 weeks, 6 months, and 12 months. GT change, KT change, root coverage (RC), clinical attachment gain, and complete root coverage (CRC) were calculated. The wound healing index, tissue appearance, patient expectations, aesthetic, and dentin hypersensitivity were assessed at baseline and 6 months.
RESULTS


All periodontal variables showed significant change from baseline to 12 months in both groups (p < 0.05). While FGG resulted in more KT change (p < 0.001), all MCAT sites showed at least 2 mm KT change in 12 months. MCAT resulted in greater GT change (p < 0.05) and RC (p < 0.003). In contrast, there was no significant inter-group CRC difference (p = 0.523). All patient-based variables were favorable to MCAT (p < 0.05), except dentin hypersensitivity (p = 0.225).
CONCLUSIONS


Both techniques were successful in terms of gingival phenotype modification in the anterior mandible. Additional GT increase, RC, and patient-based outcomes favored MCAT, though KT change proved greater with FGG.
CLINICAL RELEVANCE


Clinicians may choose MCAT for higher GT increase whereas FGG for more KTC.
TRIAL REGISTRATION NUMBER


NCT04690140 and date: 12/26/2020.",2022,MCAT resulted in greater GT change (p < 0.05) and RC (p < 0.003).,"['One hundred and forty recessions in 50 patients with thin and insufficient keratinized tissue at the anterior mandible', 'gingival phenotype modification']","['MCAT and FGG', 'modified coronally advanced tunnel technique (MCAT) and free gingival grafts (FGG', 'MCAT or FGG', 'MCAT', 'Modified coronally advanced tunnel versus epithelialized free gingival graft technique']","['gingival thickness (GT) and keratinized tissue (KT) height', 'KT change', 'GT change, KT change, root coverage (RC), clinical attachment gain, and complete root coverage (CRC', 'GT, KT height, recession depth, recession width, probing depth, and clinical attachment level', 'greater GT change', 'wound healing index, tissue appearance, patient expectations, aesthetic, and dentin hypersensitivity', 'except dentin hypersensitivity']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0398967', 'cui_str': 'Free soft dentoalveolar tissue graft procedure, including donor site'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}]",50.0,0.0460065,MCAT resulted in greater GT change (p < 0.05) and RC (p < 0.003).,"[{'ForeName': 'Birtan Tolga', 'Initials': 'BT', 'LastName': 'Yilmaz', 'Affiliation': 'Faculty of Dentistry, Periodontology Department, Hacettepe University, 06230, Sihhiye, Ankara, Turkey.'}, {'ForeName': 'Elnur', 'Initials': 'E', 'LastName': 'Comerdov', 'Affiliation': 'Faculty of Dentistry, Periodontology Department, Hacettepe University, 06230, Sihhiye, Ankara, Turkey.'}, {'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Kutuk', 'Affiliation': 'Faculty of Dentistry, Periodontology Department, Hacettepe University, 06230, Sihhiye, Ankara, Turkey.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Nart', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'H Gencay', 'Initials': 'HG', 'LastName': 'Keceli', 'Affiliation': 'Faculty of Dentistry, Periodontology Department, Hacettepe University, 06230, Sihhiye, Ankara, Turkey. monsieur_gencay@yahoo.com.'}]",Clinical oral investigations,['10.1007/s00784-022-04580-0']
2080,35708767,Psychophysiological Reactions of Internet Users Exposed to Fluoride Information and Disinformation: Protocol for a Randomized Controlled Trial.,"BACKGROUND


False messages on the internet continually propagate possible adverse effects of fluoridated oral care products and water, despite their essential role in preventing and controlling dental caries.
OBJECTIVE


This study aims to evaluate the patterns of psychophysiological reactions of adults after the consumption of internet-based fluoride-related information and disinformation.
METHODS


A 2-armed, single-blinded, parallel, and randomized controlled trial will be conducted with 58 parents or caregivers of children who attend the Clinics of Pediatric Dentistry at the Bauru School of Dentistry, considering an attrition of 10% and a significance level of 5%. The participants will be randomized into test and intervention groups, being respectively exposed to fluoride-related information and disinformation presented on a computer with simultaneous monitoring of their psychophysiological reactions, including analysis of their heart rates (HRs) and 7 facial features (mouth outer, mouth corner, eye area, eyebrow activity, face area, face motion, and facial center of mass). Then, participants will respond to questions about the utility and truthfulness of content, their emotional state after the experiment, eHealth literacy, oral health knowledge, and socioeconomic characteristics. The Shapiro-Wilk and Levene tests will be used to determine the normality and homogeneity of the data, which could lead to further statistical analyses for elucidating significant differences between groups, using parametric (Student t test) or nonparametric (Mann-Whitney U test) analyses. Moreover, multiple logistic regression models will be developed to evaluate the association of distinct variables with the psychophysiological aspects. Only factors with significant Wald statistics in the simple analysis will be included in the multiple models (P<.2). Furthermore, receiver operating characteristic curve analysis will be performed to determine the accuracy of the remote HR with respect to the measured HR. For all analyses, P<.05 will be considered significant.
RESULTS


From June 2022, parents and caregivers who frequent the Clinics of Pediatric Dentistry at the Bauru School of Dentistry will be invited to participate in the study and will be randomized into 1 of the 2 groups (control or intervention). Data collection is expected to be completed in December 2023. Subsequently, the authors will analyze the data and publish the findings of the clinical trial by June 2024.
CONCLUSIONS


This randomized controlled trial aims to elucidate differences between psychophysiological patterns of adults exposed to true or false oral health content. This evidence may support the development of further studies and digital strategies, such as neural network models to automatically detect disinformation available on the internet.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry (RBR-7q4ymr2) U1111-1263-8227; https://tinyurl.com/2kf73t3d.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/39133.",2022,Only factors with significant Wald statistics in the simple analysis will be included in the multiple models (P<.2).,"['58 parents or caregivers of children who attend the Clinics of Pediatric Dentistry at the Bauru School of Dentistry, considering an attrition of 10% and a significance level of 5', 'From June 2022, parents and caregivers who frequent the Clinics of Pediatric Dentistry at the Bauru School of Dentistry']","['Fluoride Information and Disinformation', 'fluoride-related information and disinformation presented on a computer with simultaneous monitoring of their psychophysiological reactions', 'internet-based fluoride-related information and disinformation']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030763', 'cui_str': 'Pediatric dentistry'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.287276,Only factors with significant Wald statistics in the simple analysis will be included in the multiple models (P<.2).,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Lotto', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Santana Jorge', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Tamires', 'Initials': 'T', 'LastName': 'Sá Menezes', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Ramalho', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Marchini Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bevilacqua', 'Affiliation': 'Department of Computer Science, Federal University of Fronteira Sul, Chapecó, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Cruvinel', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}]",JMIR research protocols,['10.2196/39133']
2081,35708758,(1 → 3)-β-D-Glucan-guided antifungal therapy in adults with sepsis: the CandiSep randomized clinical trial.,"PURPOSE


To investigate whether (1 → 3)-β-d-Glucan (BDG)-guidance shortens time to antifungal therapy and thereby reduces mortality of sepsis patients with high risk of invasive Candida infection (ICI).
METHODS


Multicenter, randomized, controlled trial carried out between September 2016 and September 2019 in 18 intensive care units enrolling adult sepsis patients at high risk for ICI. Patients in the control group received targeted antifungal therapy driven by culture results. In addition to targeted therapy, patients in the BDG group received antifungals if at least one of two consecutive BDG samples taken during the first two study days was ≥ 80 pg/mL. Empirical antifungal therapy was discouraged in both groups. The primary endpoint was 28-day-mortality.
RESULTS


339 patients were enrolled. ICI was diagnosed in 48 patients (14.2%) within the first 96 h after enrollment. In the BDG-group, 48.8% (84/172) patients received antifungals during the first 96 h after enrollment and 6% (10/167) patients in the control group. Death until day 28 occurred in 58 of 172 patients (33.7%) in the BDG group and 51 of 167 patients (30.5%) in the control group (relative risk 1.10; 95% confidence interval, 0.80-1.51; p = 0.53). Median time to antifungal therapy was 1.1 [interquartile range (IQR) 1.0-2.2] days in the BDG group and 4.4 (IQR 2.0-9.1, p < 0.01) days in the control group.
CONCLUSIONS


Serum BDG guided antifungal treatment did not improve 28-day mortality among sepsis patients with risk factors for but unexpected low rate of IC. This study cannot comment on the potential benefit of BDG-guidance in a more selected at-risk population.",2022,"Death until day 28 occurred in 58 of 172 patients (33.7%) in the BDG group and 51 of 167 patients (30.5%) in the control group (relative risk 1.10; 95% confidence interval, 0.80-1.51; p = 0.53).","['adults with sepsis', 'sepsis patients with high risk of invasive Candida infection (ICI', '339 patients were enrolled', 'September 2016 and September 2019 in 18 intensive care units enrolling adult sepsis patients at high risk for ICI']",['3)-β-D-Glucan-guided antifungal therapy'],"['28-day mortality', '28-day-mortality', 'ICI', 'Median time to antifungal therapy', 'Death']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0219900', 'cui_str': 'polyglucosan'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",339.0,0.182709,"Death until day 28 occurred in 58 of 172 patients (33.7%) in the BDG group and 51 of 167 patients (30.5%) in the control group (relative risk 1.10; 95% confidence interval, 0.80-1.51; p = 0.53).","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bloos', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany. frank.bloos@med.uni-jena.de.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Held', 'Affiliation': 'Mikrobiologisches Institut-Klinische Mikrobiologie Immunologie und Hygiene, Universitätsklinikum Erlangen Und Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kogelmann', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Hospital Emden, Emden, Germany.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'de Heer', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sven-Olaf', 'Initials': 'SO', 'LastName': 'Kuhn', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Greifswald, Greifswald, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Jarczak', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Motsch', 'Affiliation': 'Department of Anesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Hempel', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Weiler', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Medical Center Kiel, Kiel, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Weyland', 'Affiliation': 'Research Center Neurosensory Science, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Drüner', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Hospital Emden, Emden, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gründling', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Greifswald, Greifswald, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Wuerzburg, Würzburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Richter', 'Affiliation': 'Department of Anesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jaschinski', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care Medicine, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Onnen', 'Initials': 'O', 'LastName': 'Moerer', 'Affiliation': 'Department of Anesthesiology, University Medical Center, Georg-August-University, Göttingen, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Günther', 'Affiliation': 'University Clinic of Anaesthesiology, Intensive Care, Emergency Medicine and Pain Therapy, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schädler', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Medical Center Kiel, Kiel, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Department of Anesthesiology, Surgical Intensive Care Medicine and Pain Therapy, University Hospital Münster, Munster, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Putensen', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Ixchel', 'Initials': 'I', 'LastName': 'Castellanos', 'Affiliation': 'Department of Anesthesiology, University Hospital, Erlangen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kurzai', 'Affiliation': 'Institute for Hygiene and Microbiology, Julius Maximilians University Würzburg, Würzburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schlattmann', 'Affiliation': 'Institute of Medical Statistics, Computer Sciences and Data Science, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Oliver A', 'Initials': 'OA', 'LastName': 'Cornely', 'Affiliation': 'Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Thomas-Rüddel', 'Affiliation': 'Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-022-06733-x']
2082,35708743,Possible Impact of a 12-Month Web- and Smartphone-Based Program to Improve Long-term Physical Activity in Patients Attending Spa Therapy: Randomized Controlled Trial.,"BACKGROUND


Lack of physical activity (PA) and sedentary behaviors are leading risk factors for noncommunicable diseases (NCDs). Web- and smartphone-based interventions are effective in increasing PA in older adults and in patients with NCD. In many countries, spa therapy, commonly prescribed to patients with NCD, represents an ideal context to initiating lifestyle changes.
OBJECTIVE


This study aimed to evaluate, in patients attending spa therapy, the effectiveness of an intervention combining a face-to-face coaching and, when returning home, a web- and smartphone-based PA program on the achievement of PA guidelines (PAG) 12 months after the end of spa therapy.
METHODS


This was a 12-month, prospective, parallel-group randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received PA usual advice. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants were assessed by phone every 2 months. Primary outcome was meeting PAG (PA ≥600 metabolic equivalent of task) at 12 months. Secondary outcomes were meeting current PAG at 6 months; sedentary time, weight, waist circumference, PA, and quality of life at 6 and 12 months. Objective use data of the web- and smartphone-based PA program were collected. Analytic methods included intention to treat and constrained longitudinal data analyses.
RESULTS


The study sample included 228 participants (n=176, 77.2% females) with a mean age of 62.4 (SD 6.7) years and a mean BMI of 28.2 (SD 4.2) kg/m 2 . Approximately 53.9% (123/228) of the participants were retired. No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group than in the control group (81% vs 67% respectively, odds ratio 2.34, 95% CI 1.02-5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight, and waist circumference at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in the intervention group than in the control group (mean difference: 4.1, 95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 (SD 4.5) months. Attrition rate during the first 2 months was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months.
CONCLUSIONS


PA increased in both the intervention group and the control group. However, at 12 months, more participants met PAG in the intervention group compared with the controls. This indicates that the web- and smartphone-based program could have maintained PA in the intervention group. In addition, a spa therapy seems to be an ideal time and framework to implement PA education.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.",2022,"No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight, and waist circumference at 6 and 12 months.","['Patients Attending Spa Therapy', '228 participants (n=176, 77.2% females) with a mean age of 62.4 (SD 6.7) years and a mean BMI of 28.2 (SD 4.2) kg/m 2 ', 'older adults and in patients with NCD', 'patients attending spa therapy']","['12-Month Web- and Smartphone-Based Program', 'intervention or control group who received PA usual advice', 'Web- and smartphone-based interventions', 'web- and smartphone-based PA program', 'intervention combining a face-to-face coaching and, when returning home, a web- and smartphone-based PA program']","['quality of life, the physical component subscale score', 'meeting PAG (PA ≥600 metabolic equivalent of task', 'proportion of patients achieving PAG', 'meeting current PAG at 6 months; sedentary time, weight, waist circumference, PA, and quality of life', 'Attrition rate', 'PA, weight, waist circumference, and quality of life', 'sedentary time, weight, and waist circumference', 'mean duration use']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0579192', 'cui_str': 'Returned home'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0228398', 'cui_str': 'Structure of periaqueductal gray matter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2983100', 'cui_str': 'Metabolic equivalent of task'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",228.0,0.0848979,"No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight, and waist circumference at 6 and 12 months.","[{'ForeName': 'Florie', 'Initials': 'F', 'LastName': 'Fillol', 'Affiliation': 'Biomouv SAS Inc, Paris, France.'}, {'ForeName': 'Ludivine', 'Initials': 'L', 'LastName': 'Paris', 'Affiliation': 'University of Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Pascal', 'Affiliation': 'Biomouv SAS Inc, Paris, France.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Mulliez', 'Affiliation': 'Biostatistics Unit (Clinical Research and Innovation Direction), University-Hospital Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Christian-François', 'Initials': 'CF', 'LastName': 'Roques', 'Affiliation': 'Physical and Rehabilitation Medicine, Paul Sabatier University, Toulouse University, Toulouse, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Rousset', 'Affiliation': 'Human Nutrition Unity, Centre de Recherche en Nutrition Humaine Auvergne, French National Institute for Agriculture, Food and Environment (INRAE), Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Human Nutrition Unity, Centre de Recherche en Nutrition Humaine Auvergne, French National Institute for Agriculture, Food and Environment (INRAE), Clermont-Ferrand, France.'}]",Journal of medical Internet research,['10.2196/29640']
2083,35708715,Achievement of ESC/EAS LDL-C treatment goals after an acute coronary syndrome with statin and alirocumab.,"AIMS


European guidelines set low-density lipoprotein cholesterol (LDL-C) treatment goals <1.4 mmol/L after acute coronary syndrome (ACS), and <1.0 mmol/L for patients with recurrent cardiovascular events ≤2 years. Many ACS patients do not achieve these goals on statin alone. We examined actual goal achievement with alirocumab and projected achievement with ezetimibe, either added to optimized statin therapy.
METHODS AND RESULTS


The ODYSSEY OUTCOMES trial (NCT01663402) compared alirocumab with placebo in 18,924 patients with recent ACS and hyperlipidaemia despite high-intensity or maximum-tolerated statin therapy. This subanalysis comprised 17,589 patients with LDL-C ≥1.4 mmol/L at baseline who did not receive ezetimibe treatment. High-intensity statin treatment was used in 88.8%. Median (interquartile range) baseline LDL-C was 2.3 (1.9-2.7) mmol/L. With alirocumab, 94.6% of patients achieved LDL-C <1.4 mmol/L at ≥1 post-baseline measurement vs. 17.3% with placebo. Among 2236 patients with a previous cardiovascular event within 2 years (before the qualifying ACS), 85.2% vs. 3.5%, respectively, achieved LDL-C <1.0 mmol/L. Among patients not treated with ezetimibe, we projected that its use would have achieved LDL-C <1.4 and <1.0 mmol/L in 10.6% and 0%, respectively at baseline (assuming 18 ± 3% reduction of LDL-C).
CONCLUSION


Among patients with recent ACS and LDL-C ≥1.4 mmol/L despite optimized statin therapy, addition of alirocumab allowed 94.6% to achieve the 2019 European guideline LDL-C goal <1.4 mmol/L, and 85.2% of those with recurrent cardiovascular events to achieve <1.0 mmol/L. In contrast, addition of ezetimibe to optimized statin therapy was projected to achieve LDL-C <1.4 mmol/L in only 10.6% of patients at baseline.",2022,"With alirocumab, 94.6% of patients achieved LDL-C <1.4 mmol/L at ≥1 post-baseline measurement vs. 17.3% with placebo.","['2236 patients with a previous cardiovascular event within 2 years (before the qualifying ACS), 85.2% vs. 3.5%, respectively, achieved LDL-C <1.0\u2005mmol/L', 'acute coronary syndrome with statin and alirocumab', 'patients with recurrent cardiovascular events ≤2 years', '17,589 patients with LDL-C ≥1.4\u2005mmol/L at baseline who did not receive ezetimibe treatment', '18,924 patients with recent ACS and hyperlipidaemia despite high-intensity or maximum-tolerated statin therapy']","['alirocumab with placebo', 'ezetimibe', 'ezetimibe, either added to optimized statin therapy', 'ESC/EAS LDL-C', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",[],18924.0,0.0450586,"With alirocumab, 94.6% of patients achieved LDL-C <1.4 mmol/L at ≥1 post-baseline measurement vs. 17.3% with placebo.","[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Department of Cardiology, Charite Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McGinniss', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NJ, USA.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Mirza', 'Initials': 'M', 'LastName': 'Dilic', 'Affiliation': 'University Clinical Center Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Loy', 'Affiliation': 'Sanofi, New Jersey, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Pećin', 'Affiliation': 'University of Zagreb, Zagreb School of Medicine, University Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Steen H', 'Initials': 'SH', 'LastName': 'Poulsen', 'Affiliation': 'Aarhus Universitetshospital Skejby, Aarhus N, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, NY, USA.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of preventive cardiology,['10.1093/eurjpc/zwac107']
2084,35708709,Efficacy and Safety of a Pegasparaginase-Based Chemotherapy Regimen vs an L-asparaginase-Based Chemotherapy Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma: A Randomized Clinical Trial.,"Importance


The L-asparaginase-based SMILE (dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide) chemotherapy regimen has shown higher response rates and survival benefit over an anthracycline-containing regimen. However, the safety profile was not satisfied. A well-tolerated regimen with promising efficacy is lacking.
Objective


To compare the efficacy and safety of the DDGP (dexamethasone, cisplatin, gemcitabine, and pegaspargase) regimen with the SMILE regimen in newly diagnosed advanced-stage (III/IV) extranodal natural killer/T-cell lymphoma (ENKL).
Design, Setting, and Participants


This was an open-label, multicenter, randomized clinical trial that took place across 12 participating hospitals in China from January 2011 to February 2019. Patients were eligible if they were 14 to 70 years old with newly diagnosed ENKL in stages III/IV and had an Eastern Cooperative Oncology Group performance status of 0 to 2. Eligible patients were evenly randomized to either the DDGP or SMILE group.
Interventions


Patients in each group were treated with the assigned regimen every 21 days for 6 cycles.
Main Outcomes and Measures


The primary end point was progression-free survival (PFS), and secondary end points included overall response rate and overall survival (OS). The adverse events between the DDGP and SMILE groups were compared.
Results


Among the 87 randomized patients, 80 received treatment (40 in the DDGP group and 40 in the SMILE group); the median (IQR) age was 43 (12) years, and 51 (64%) were male. The baseline characteristics were similar between the groups. At a median follow-up of 41.5 months, the median PFS was not reached in the DDGP group vs 6.8 months in the SMILE group (HR, 0.42; 95% CI, 0.23-0.77; P = .004), and the median OS was not reached in the DDGP group vs 75.2 months in the SMILE group (HR, 0.41; 95% CI, 0.19-0.89, P = .02). The PFS rate at 3 years and OS rate at 5 years were higher in the DDGP group vs the SMILE group (3-year PFS, 56.6% vs 41.8%; 5-year OS, 74.3% vs 51.7%). The overall response rate was higher in the DDGP group than in the SMILE group (90.0% vs 60.0%; P = .002). Grade 3 and 4 hematologic toxic effects were more frequently reported in the SMILE group vs the DDGP group (leukopenia, 85.0% vs 62.5%; neutropenia, 85.0% vs 65.0%).
Conclusions and Relevance


In this randomized clinical trial, the DDGP regimen showed promising preliminary results for patients with newly diagnosed local advanced ENKL. A confirmation trial based on larger population is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT01501149.",2022,"The PFS rate at 3 years and OS rate at 5 years were higher in the DDGP group vs the SMILE group (3-year PFS, 56.6% vs 41.8%; 5-year OS, 74.3% vs 51.7%).","['Eligible patients', '87 randomized patients, 80 received treatment (40 in the DDGP group and 40 in the SMILE group); the median (IQR) age was 43 (12) years, and 51 (64%) were male', 'Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma', 'Patients were eligible if they were 14 to 70 years old with newly diagnosed ENKL in stages III/IV and had an Eastern Cooperative Oncology Group performance status of 0 to 2', 'patients with newly diagnosed local advanced ENKL', 'newly diagnosed advanced-stage (III/IV) extranodal natural killer/T-cell lymphoma (ENKL', '12 participating hospitals in China from January 2011 to February 2019']","['DDGP or SMILE', 'DDGP', 'L-asparaginase-based SMILE (dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide) chemotherapy regimen', 'Pegasparaginase-Based Chemotherapy Regimen vs an L-asparaginase-Based Chemotherapy Regimen', 'DDGP (dexamethasone, cisplatin, gemcitabine, and pegaspargase) regimen with the SMILE regimen']","['adverse events', 'overall response rate', 'Grade 3 and 4 hematologic toxic effects', 'OS rate', 'efficacy and safety', 'overall response rate and overall survival (OS', 'Efficacy and Safety', 'progression-free survival (PFS', 'median OS', 'PFS rate', 'median PFS', 'neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0079772', 'cui_str': 'T-cell lymphoma (clinical)'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",87.0,0.233716,"The PFS rate at 3 years and OS rate at 5 years were higher in the DDGP group vs the SMILE group (3-year PFS, 56.6% vs 41.8%; 5-year OS, 74.3% vs 51.7%).","[{'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiangli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiaorui', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Zhenchang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Jiaqin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Nan', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Minrui', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Zhaoming', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Linan', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Cunzhen', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Jiwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Mengjie', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Jieming', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Nanjing Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, Sichuan University West China Hospital, Chengdu, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Su', 'Affiliation': 'Department of Hematology, Tumor Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Jianqiu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Huizheng', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': 'Department of Lymphoma and Hematology, Jilin Cancer Hospital, Jilin, China.'}, {'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hefei, China.'}, {'ForeName': 'Yanzhen', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.'}, {'ForeName': 'Shuxia', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': ""Department of Hematology, Zhengzhou People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Oncology, Xinxiang Central Hospital, Xinxiang, China.'}, {'ForeName': 'Ken H', 'Initials': 'KH', 'LastName': 'Young', 'Affiliation': 'Division of Hematopathology, Department of Pathology, Duke University Medical Center and Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Wencai', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}]",JAMA oncology,['10.1001/jamaoncol.2022.1968']
2085,35708706,Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.,"Importance


The port delivery system (PDS) with ranibizumab has demonstrated noninferior and equivalent efficacy compared with monthly intravitreal injections of ranibizumab, an anti-vascular endothelial growth factor (VEGF) agent, in patients with neovascular age-related macular degeneration (nAMD), but evaluating patient preference is important to help inform clinical decision-making.
Objective


Evaluate treatment satisfaction for ranibizumab delivered via PDS vs intravitreal injections as well as patient preference among those assigned to PDS.
Design, Setting, and Participants


Archway was a phase 3 randomized active-comparator open-label clinical trial conducted at 78 sites in the US. Patients 50 years and older with nAMD diagnosed within 9 months of screening with a documented response to anti-VEGF therapy were included. Of 619 patients screened, 418 were enrolled; 415 were included in the primary analysis and 234 were included in the secondary exploratory analysis. The Archway study ran from September 12, 2019, through primary readout on May 22, 2020.
Interventions


Patients were randomized 3:2 to PDS with ranibizumab, 100 mg/mL, with fixed refill exchanges every 24 weeks or intravitreal ranibizumab injections, 0.5 mg, every 4 weeks.
Main Outcomes and Measures


Treatment satisfaction was measured using the Macular Disease Treatment Satisfaction Questionnaire in the PDS and intravitreal injection arms at week 40. Patient preference was assessed using the content-validated PDS Patient Preference Questionnaire (PPPQ), which measured the proportion of patients in the PDS arm with monthly monitoring who preferred treatment with the PDS at week 40 over previous intravitreal injections or concurrent fellow-eye injections. Both outcomes were exploratory end points.
Results


The mean (SD) age of participants at baseline was 75.0 (7.9) years; 234 participants (59%) were women and 162 (41%) were men. At week 40, differences in overall treatment satisfaction scores were minimal for the PDS and intravitreal injection arms (mean, 68.0; 95% CI, 67.4-68.6; n = 237 and mean, 66.1; 95% CI, 64.9-67.3; n = 159, respectively; difference, 1.9; 95% CI, 0.7-3.1). A total of 234 of 248 patients (94.4%) in the PDS arm were included in the PPPQ analysis. At week 40, almost all patients in the PDS arm preferred treatment via PDS (218 of 234 [93.2%]) vs previous intravitreal injections (3 of 234 [1.3%]), including 172 of 234 (73.5%) with a very strong preference for the PDS. In patients who received concurrent fellow-eye injections (n = 78), 72 (92.3%) preferred the PDS.
Conclusions and Relevance


Although PDS treatment was preferred by almost all patients assigned to PDS over previous intravitreal injections, both delivery methods have high treatment satisfaction. These findings provide further evidence for the PDS as a meaningful alternative treatment option for patients with nAMD.
Trial Registration


ClinicalTrials.gov Identifier: NCT03677934.",2022,"At week 40, differences in overall treatment satisfaction scores were minimal for the PDS and intravitreal injection arms (mean, 68.0; 95% CI, 67.4-68.6; n = 237 and mean, 66.1; 95% CI, 64.9-67.3; n = 159, respectively; difference, 1.9; 95% CI, 0.7-3.1).","['patients with nAMD', 'patients with neovascular age-related macular degeneration (nAMD', 'The mean (SD) age of participants at baseline was 75.0 (7.9) years; 234 participants (59%) were women and 162 (41%) were men', '619 patients screened, 418 were enrolled; 415 were included in the primary analysis and 234 were included in the secondary exploratory analysis', 'Patients With Neovascular Age-Related Macular Degeneration', 'The Archway study ran from September 12, 2019, through primary readout on May 22, 2020', 'A total of 234 of 248 patients (94.4%) in the PDS arm were included in the PPPQ analysis', 'Patients 50 years and older with nAMD diagnosed within 9 months of screening with a documented response to anti-VEGF therapy were included']","['ranibizumab', 'Ranibizumab vs Intravitreal Injections', 'ranibizumab delivered via PDS vs intravitreal injections', 'PDS with ranibizumab, 100 mg/mL, with fixed refill exchanges every 24 weeks or intravitreal ranibizumab injections']","['content-validated PDS Patient Preference Questionnaire (PPPQ', 'Macular Disease Treatment Satisfaction Questionnaire', 'overall treatment satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C0730362', 'cui_str': 'Disorder of macula of retina'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",418.0,0.264057,"At week 40, differences in overall treatment satisfaction scores were minimal for the PDS and intravitreal injection arms (mean, 68.0; 95% CI, 67.4-68.6; n = 237 and mean, 66.1; 95% CI, 64.9-67.3; n = 159, respectively; difference, 1.9; 95% CI, 0.7-3.1).","[{'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Chang', 'Affiliation': 'Retinal Consultants, Sacramento, California.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Kapre', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Kaufman', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Kardatzke', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Rabena', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Shienal', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Bobbala', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fung', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Wallenstein', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2022.1091']
2086,35708700,High intensity exercise and passive hot water immersion cause similar post intervention changes in peripheral and cerebral shear.,"Passive hot water immersion (PHWI) provides a peripheral vasculature shear stimulus comparable to low intensity exercise within the active skeletal muscle, whereas moderate and high intensity exercise elicit substantially greater shear rates in the peripheral vasculature, likely conferring greater vascular benefits. Few studies have compared post intervention shear rates in the peripheral and cerebral vasculature following high intensity exercise and PHWI, especially considering that the post intervention recovery period represents a key window in which adaptation occurs. Therefore, we aimed to compare shear rates in the internal carotid artery (ICA), vertebral artery (VA) and common femoral artery (CFA) between high intensity exercise and PHWI for up to 80 minutes post intervention. Fifteen healthy (27 ± 4 years), moderately trained individuals underwent three-time matched interventions in a randomised order which included 30 minutes of whole-body immersion in a 42°C hot bath, 30 minutes of treadmill running and 5x4 minute high intensity intervals (HIIE). There were no differences in ICA (P= 0.4643) and VA (P=0.1940) shear rates between PHWI and exercise (both continuous and HIIE) post intervention. All three interventions elicited comparable increases in CFA shear rate post intervention (P=0.0671), however, CFA shear rate was slightly higher 40 minutes post threshold running (P=0.0464) and, slightly higher, although not statically for HIIE (P=0.0565) compared with PHWI. Our results suggest that time and core temperature matched high intensity exercise and PHWI elicit limited changes in cerebral shear and comparable increases in peripheral vasculature shear rates when measured for up to 80 minutes post intervention.",2022,There were no differences in ICA (P= 0.4643) and VA (P=0.1940) shear rates between PHWI and exercise (both continuous and HIIE) post intervention.,['Fifteen healthy (27 ± 4 years'],"['Passive hot water immersion (PHWI', 'whole-body immersion in a 42°C hot bath, 30 minutes of treadmill running and 5x4 minute high intensity intervals (HIIE', 'High intensity exercise and passive hot water immersion']","['peripheral and cerebral shear', 'peripheral vasculature shear rates', 'ICA', 'shear rates', 'CFA shear rate']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0337023', 'cui_str': 'Hot water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0447105', 'cui_str': 'Common femoral artery'}]",,0.014732,There were no differences in ICA (P= 0.4643) and VA (P=0.1940) shear rates between PHWI and exercise (both continuous and HIIE) post intervention.,"[{'ForeName': 'Sachin B', 'Initials': 'SB', 'LastName': 'Amin', 'Affiliation': 'University Innsbruck, Department Sport Science, Innsbruck, Austria.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Hansen', 'Affiliation': 'University Innsbruck, Department Sport Science, Innsbruck, Austria.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Mugele', 'Affiliation': 'University Innsbruck, Department Sport Science, Innsbruck, Austria.'}, {'ForeName': 'Lydia L', 'Initials': 'LL', 'LastName': 'Simpson', 'Affiliation': 'University Innsbruck, Department Sport Science, Innsbruck, Austria.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Marume', 'Affiliation': 'University Innsbruck, Department Sport Science, Innsbruck, Austria.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Moore', 'Affiliation': 'School of Sport, Health and Exercise Science, Bangor University, Bangor, United Kingdom.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Cornwell', 'Affiliation': 'Department of Medicine - Cardiology, University of Colorado Anschutz Medical Campus, Aurora CO, United States.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Lawley', 'Affiliation': 'University Innsbruck, Department Sport Science, Innsbruck, Austria.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00780.2021']
2087,35708698,Patient-Reported Outcome Measures in a Clinical Trial of the Port Delivery System With Ranibizumab.,,2022,,[],['Ranibizumab'],[],[],"[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}]",[],,0.582305,,"[{'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2022.2133']
2088,35708696,Active Surveillance Plus Enzalutamide Monotherapy vs Active Surveillance Alone in Patients With Low-risk or Intermediate-risk Localized Prostate Cancer: The ENACT Randomized Clinical Trial.,"Importance


There are few published studies prospectively assessing pharmacological interventions that may delay prostate cancer progression in patients undergoing active surveillance (AS).
Objective


To compare the efficacy and safety of enzalutamide monotherapy plus AS vs AS alone in patients with low-risk or intermediate-risk prostate cancer.
Design, Setting, and Participants


The ENACT study was a phase 2, open-label, randomized clinical trial conducted from June 2016 to August 2020 at 66 US and Canadian sites. Eligible patients were 18 years or older, had received a diagnosis of histologically proven low-risk or intermediate-risk localized prostate cancer within 6 months of screening, and were undergoing AS. Patients were monitored during 1 year of treatment and up to 2 years of follow-up. Data analysis was conducted in February 2021.
Interventions


Randomized 1:1 to enzalutamide, 160 mg, monotherapy for 1 year or continued AS, as stratified by cancer risk and follow-up biopsy type.
Main Outcomes and Measures


The primary end point was time to pathological or therapeutic prostate cancer progression (pathological, ≥1 increase in primary or secondary Gleason pattern or ≥15% increased cancer-positive cores; therapeutic, earliest occurrence of primary therapy for prostate cancer). Secondary end points included incidence of a negative biopsy result, percentage of cancer-positive cores, and incidence of a secondary rise in serum prostate-specific antigen (PSA) levels at 1 and 2 years, as well as time to PSA progression. Adverse events were monitored to assess safety.
Results


A total of 114 patients were randomized to treatment with enzalutamide plus AS and 113 to AS alone; baseline characteristics were similar between treatment arms (mean [SD] age, 66.1 [7.8] years; 1 Asian individual [0.4%], 21 Black or African American individuals [9.3%], 1 Hispanic individual [0.4%], and 204 White individuals [89.9%]). Enzalutamide significantly reduced the risk of prostate cancer progression by 46% vs AS (hazard ratio, 0.54; 95% CI, 0.33-0.89; P = .02). Compared with AS, odds of a negative biopsy result were 3.5 times higher; there was a significant reduction in the percentage of cancer-positive cores and the odds of a secondary rise in serum PSA levels at 1 year with treatment with enzalutamide; no significant difference was observed at 2 years. Treatment with enzalutamide also significantly delayed PSA progression by 6 months vs AS (hazard ratio, 0.71; 95% CI, 0.53-0.97; P = .03). The most commonly reported adverse events during enzalutamide treatment were fatigue (62 [55.4%]) and gynecomastia (41 [36.6%]). Three patients in the enzalutamide arm died; none were receiving the study drug at the time of death. No deaths were considered treatment-related.
Conclusions and Relevance


The results of this randomized clinical trial suggest that enzalutamide monotherapy was well-tolerated and demonstrated a significant treatment response in patients with low-risk or intermediate-risk localized prostate cancer. Enzalutamide may provide an alternative treatment option for patients undergoing AS.
Trial Registration


ClinicalTrials.gov Identifier: NCT02799745.",2022,"Treatment with enzalutamide also significantly delayed PSA progression by 6 months vs AS (hazard ratio, 0.71; 95% CI, 0.53-0.97; P = .03).","['June 2016 to August 2020 at 66 US and Canadian sites', 'patients with low-risk or intermediate-risk localized prostate cancer', 'A total of 114 patients', 'Patients With Low-risk or Intermediate-risk Localized Prostate Cancer', 'patients undergoing active surveillance (AS', 'patients undergoing AS', 'and 113 to AS alone; baseline characteristics were similar between treatment arms (mean [SD] age, 66.1 [7.8] years; 1 Asian individual [0.4%], 21 Black or African American individuals [9.3%], 1 Hispanic individual [0.4%], and 204 White individuals [89.9', 'patients with low-risk or intermediate-risk prostate cancer', 'Eligible patients were 18 years or older, had received a diagnosis of histologically proven low-risk or intermediate-risk localized prostate cancer within 6 months of screening, and were undergoing AS']","['enzalutamide monotherapy', 'enzalutamide monotherapy plus AS vs AS alone', 'enzalutamide', 'Enzalutamide', 'enzalutamide plus AS', 'enzalutamide, 160 mg, monotherapy']","['adverse events', 'gynecomastia', 'efficacy and safety', 'Adverse events', 'serum PSA levels', 'incidence of a negative biopsy result, percentage of cancer-positive cores, and incidence of a secondary rise in serum prostate-specific antigen (PSA) levels at 1 and 2 years, as well as time to PSA progression', 'percentage of cancer-positive cores', 'time to pathological or therapeutic prostate cancer progression (pathological, ≥1 increase in primary or secondary Gleason pattern or ≥15% increased cancer-positive cores; therapeutic, earliest occurrence of primary therapy for prostate cancer', 'delayed PSA progression', 'risk of prostate cancer progression']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018418', 'cui_str': 'Gynecomastia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1273605', 'cui_str': 'Secondary Gleason pattern'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",114.0,0.356767,"Treatment with enzalutamide also significantly delayed PSA progression by 6 months vs AS (hazard ratio, 0.71; 95% CI, 0.53-0.97; P = .03).","[{'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, South Carolina.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Renzulli', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Fleshner', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Courtney M P', 'Initials': 'CMP', 'LastName': 'Hollowell', 'Affiliation': 'Cook County Health, Chicago, Illinois.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Vourganti', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Silberstein', 'Affiliation': 'Memorial Healthcare System, Hollywood, Florida.'}, {'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Siddiqui', 'Affiliation': 'Astellas Pharma Inc, Northbrook, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hairston', 'Affiliation': 'Astellas Pharma Inc, Northbrook, Illinois.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Elsouda', 'Affiliation': 'Astellas Pharma Inc, Northbrook, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Tomlins', 'Affiliation': 'Departments of Pathology and Urology, Rogel Cancer Center, University of Michigan Medical School, Ann Arbor.'}]",JAMA oncology,['10.1001/jamaoncol.2022.1641']
2089,35708691,Australian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information: A Randomized Clinical Trial.,"Importance


Whether the benefits of notifying women about breast density outweigh the potential harms to inform current and future mammogram screening practice remains unknown.
Objective


To assess the effect of mammographic breast density notification and information provision on women's intention to seek supplemental screening and psychological outcomes.
Design, Setting, and Participants


A 3-arm online randomized clinical trial was conducted from August 10 to 31, 2021. Data analysis was conducted from September 1 to October 20, 2021. Participants included Australian residents identifying as female, aged between 40 and 74 years, with no history of breast cancer who were residing in jurisdictions without existing breast density notification with screening mammograms.
Interventions


Women were randomized to receive 1 of the following hypothetical breast screening test result letters: screening mammogram result letter without breast density messaging (control), screening mammogram result letter with breast density messaging and an existing density information letter taken from a screening service in Australia (intervention 1), and screening mammogram result letter with breast density messaging and a health literacy-sensitive version of the letter adapted for people with lower health literacy (intervention 2).
Main Outcomes and Measures


Primary outcomes were intention to seek supplemental screening; feeling anxious (uneasy, worried, or nervous), informed, or confused; and having breast cancer worry.
Results


A total of 1420 Australian women were randomized and included in the final analysis. The largest group consisted of 603 women aged 60 to 74 years (42.5%). Compared with the control cohort (n = 480), women who received density notification via intervention 1 (n = 470) and intervention 2 (n = 470) reported a significantly higher intention to seek supplemental screening (0.8% vs 15.6% and 14.2%; P < .001) and feeling anxious (14.2% vs 49.4% and 48.5%; P < .001), confusion (7.8% vs 24.0% and 23.6%; P < .001), and worry about breast cancer (quite/very worried: 6.9% vs 17.2% and 15.5%; P < .001). There were no statistically significant differences in these outcomes between the 2 intervention groups.
Conclusions and Relevance


In this randomized clinical trial, breast density notification and information integrated with screening mammogram results increased women's intention to seek supplemental screening and made women feel anxious, confused, or worried about breast cancer. These findings have relevance and implications for mammogram screening services and policy makers considering whether and, if so, how best to implement widespread notification of breast density as part of mammography screening.
Trial Registration


ACTRN12621000253808.",2022,"There were no statistically significant differences in these outcomes between the 2 intervention groups.
","['Participants included Australian residents identifying as female, aged between 40 and 74 years, with no history of breast cancer who were residing in jurisdictions without existing breast density notification with screening mammograms', '603 women aged 60 to 74 years (42.5', 'A total of 1420 Australian women', ""Australian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information"", 'Interventions\n\n\nWomen']","['mammographic breast density notification and information provision', 'hypothetical breast screening test result letters: screening mammogram result letter without breast density messaging (control), screening mammogram result letter with breast density messaging and an existing density information letter taken from a screening service in Australia (intervention 1), and screening mammogram result letter with breast density messaging and a health literacy-sensitive version of the letter adapted for people with lower health literacy (intervention 2']","['confusion', 'worry about breast cancer', 'higher intention to seek supplemental screening', 'intention to seek supplemental screening; feeling anxious (uneasy, worried, or nervous), informed, or confused; and having breast cancer worry', 'feeling anxious']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1659543', 'cui_str': 'Breast Density'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0203028', 'cui_str': 'Screening mammography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1268717', 'cui_str': 'Mammographic breast density'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C1659543', 'cui_str': 'Breast Density'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424142', 'cui_str': 'Ill-at-ease'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",603.0,0.18841,"There were no statistically significant differences in these outcomes between the 2 intervention groups.
","[{'ForeName': 'Hankiz', 'Initials': 'H', 'LastName': 'Dolan', 'Affiliation': 'Wiser Healthcare, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'McCaffery', 'Affiliation': 'Wiser Healthcare, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Nehmat', 'Initials': 'N', 'LastName': 'Houssami', 'Affiliation': 'Wiser Healthcare, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cvejic', 'Affiliation': 'Wiser Healthcare, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Brennan', 'Affiliation': 'University of Notre Dame Australia, School of Medicine Sydney, Sydney, Australia.'}, {'ForeName': 'Jolyn', 'Initials': 'J', 'LastName': 'Hersch', 'Affiliation': 'Wiser Healthcare, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Dorrington', 'Affiliation': 'Bungendore Medical Centre, Bungendore, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Verde', 'Affiliation': 'Breast Cancer Network Australia, Melbourne, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vaccaro', 'Affiliation': 'Health Consumers New South Wales, Sydney, Australia.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Nickel', 'Affiliation': 'Wiser Healthcare, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.16784']
2090,35708690,Effectiveness of a COVID-19 Testing Outreach Intervention for Latinx Communities: A Cluster Randomized Trial.,"Importance


Latinx individuals have been disproportionately affected during the COVID-19 pandemic caused by the spread of SARS-CoV-2. It is imperative to evaluate newly developed preventive interventions to assess their effect on COVID-19 health disparities.
Objective


To examine the effectiveness of a culturally tailored outreach intervention designed to increase SARS-CoV-2 testing rates among Latinx populations.
Design, Setting, and Participants


In this cluster randomized trial performed from February 1 to August 31, 2021, in community settings in 9 Oregon counties, 38 sites were randomized a priori (19 to the community health promoters intervention and 19 to outreach as usual wait-listed controls). Thirty-three sites were activated. A total of 394 SARS-CoV-2 testing events were held and 1851 diagnostic samples collected, of which 919 were from Latinx persons.
Interventions


A culturally informed outreach program was developed that made use of promotores de salud (community health promoters) to increase Latinx SARS-CoV-2 testing. Strategies addressed barriers by disseminating information on testing events in English and Spanish, mitigating misinformation, and increasing trust.
Main Outcomes and Measures


The primary outcomes were the count of sample tests from Latinx persons and the sampled proportion of the Latinx populace. Site-level covariates included census tract Latinx populace, nativity (number of US-born individuals per 100 population), median age, and income inequality. Time-varying covariates included number of new weekly SARS-CoV-2-positive cases and percentage of vaccine coverage at the county level.
Results


A total of 15 clusters (sites) were randomized to the control group and 18 to the community health promoters group. A total of 1851 test samples were collected, of which 995 (53.8%) were from female participants and 919 (49.6%) were from Latinx individuals. The intervention tested 3.84 (95% CI, 2.47-5.97) times more Latinx individuals per event than controls (incident rate ratio, 0.79; 95% CI, 0.46-1.34; Cohen d = 0.74; P < .001). The intervention was associated with a 0.28 increase in the proportion of Latinx populace being tested compared with control sites for the dependent variable scaled as the proportion of the Latinx populace ×100, or a 0.003 proportion of the raw populace count. The use of a standardized scaling of the proportion of Latinx individuals showed that the relative percentage increase was 0.53 (95% CI, 0.21-0.86) in the intervention sites compared with controls, representing a medium effect size.
Conclusions and Relevance


To our knowledge, this was the first randomized evaluation of an outreach intervention designed to increase SARS-CoV-2 testing among Latinx populations. Findings could be used to implement strategies to reduce other health disparities experienced by these groups.
Trial Registration


ClinicalTrials.gov Identifier: NCT04793464.",2022,"The intervention tested 3.84 (95% CI, 2.47-5.97) times more Latinx individuals per event than controls (incident rate ratio, 0.79; 95% CI, 0.46-1.34; Cohen d = 0.74; P < .001).","['A total of 1851 test samples were collected, of which 995 (53.8%) were from female participants and 919 (49.6%) were from Latinx individuals', 'Latinx populations', 'February 1 to August 31, 2021, in community settings in 9 Oregon counties, 38 sites', 'Latinx Communities', 'A total of 15 clusters (sites) were randomized to the control group and 18 to the community health promoters group']","['COVID-19 Testing Outreach Intervention', 'culturally tailored outreach intervention', 'community health promoters intervention and 19 to outreach as usual wait-listed controls']","['SARS-CoV-2 testing rates', 'proportion of Latinx populace', 'tract Latinx populace, nativity (number of US-born individuals per 100 population), median age, and income inequality', 'count of sample tests from Latinx persons and the sampled proportion of the Latinx populace']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0242503', 'cui_str': 'Unequal'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0934327,"The intervention tested 3.84 (95% CI, 2.47-5.97) times more Latinx individuals per event than controls (incident rate ratio, 0.79; 95% CI, 0.46-1.34; Cohen d = 0.74; P < .001).","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'DeGarmo', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'De Anda', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}, {'ForeName': 'Camille C', 'Initials': 'CC', 'LastName': 'Cioffi', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}, {'ForeName': 'Hannah F', 'Initials': 'HF', 'LastName': 'Tavalire', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Searcy', 'Affiliation': 'Presidential Initiative in Data Science, University of Oregon, Eugene.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Budd', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Hawley McWhirter', 'Affiliation': 'Department of Counseling Psychology and Human Services, University of Oregon, Eugene.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Mauricio', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Halvorson', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Beck', 'Affiliation': 'Presidential Initiative in Data Science, University of Oregon, Eugene.'}, {'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Fernandes', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Currey', 'Affiliation': 'Institute of Ecology and Evolution, University of Oregon, Eugene.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Ramírez García', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Cresko', 'Affiliation': 'Presidential Initiative in Data Science, University of Oregon, Eugene.'}, {'ForeName': 'Leslie D', 'Initials': 'LD', 'LastName': 'Leve', 'Affiliation': 'Prevention Science Institute, University of Oregon, Eugene.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.16796']
2091,35709102,Rituximab for thyroid-associated ophthalmopathy.,"BACKGROUND


Thyroid-associated ophthalmopathy (TAO) is the most frequent extrathyroidal manifestation of Graves' disease, affecting up to 50% of patients. It has a great impact on quality of life. Rituximab (RTX) is a human/murine chimeric monoclonal antibody that targets the CD20 receptor on B-lymphocytes. Preliminary work has shown that blocking this CD20 receptor with RTX may affect the clinical course of TAO by reducing inflammation and the degree of proptosis.  OBJECTIVES: This review update, originally published in 2013, assesses the efficacy and safety of using RTX for the treatment of TAO.
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2022, Issue 2), which contains the Cochrane Eyes and Vision Trials Register, Ovid MEDLINE, Ovid Embase, Latin American and Caribbean Health Science Information database (LILACS), the ISRCTN registry, clinicaltrials.gov and the WHO International Clinical Trials Registry Platform (WHO ICTRP). There were no language restrictions in the electronic search for trials. We last searched the electronic databases on 22 February 2022.  SELECTION CRITERIA: We included randomised controlled trials (RCTs) of RTX administered by intravenous infusion using any dosage regimen for the treatment of active TAO in adults, compared to placebo or glucocorticoids treatment.  DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently scanned titles and abstracts, and screened full-text reports of potentially relevant studies. The outcomes of interest in this review were: clinical activity score (CAS), NOSPECS severity scale, proptosis (mm), palpebral aperture (mm), extraocular motility (degrees or diplopia rating scale), quality of life and adverse effects.
MAIN RESULTS


We identified two studies that met the inclusion criteria in this updated review. Across both studies, the mean age of participants was 55 years and 77% were women. RTX compared to intravenous methylprednisolone (IVMP) One study, conducted in Italy, compared RTX (n = 15 after one participant withdrew) with IVMP (n = 16) for active TAO (CAS ≥ 3 out of 7 or 4 out of 10). We judged this study to be at low risk of bias in most domains, but it was stopped early because of disease reactivation in the comparator group (5/16 participants). This study provided low-certainty evidence that RTX may result in CAS improvement at 24 weeks compared to IVMP (15/15 versus 12/16 improved by ≥ 2 points; risk ratio (RR) 1.32, 95% confidence interval (CI) 0.98 to 1.78). Only very low-certainty evidence was available for the other outcomes: NOSPECS improvement by 2 or more classes (3/15 versus 3/16; RR 1.07, 95% CI 0.25 to 4.49); proptosis improvement by 2 mm or more (0/15 versus 1/16; RR 0.35, 95% CI 0.02 to 8.08); palpebral aperture improvement by 3 mm or more (2/15 versus 0/16; RR 5.31, 95% CI 0.28 to 102.38); motility improvement by 1 class or more (3/15 versus 3/16; RR 1.07, 95% CI 0.25 to 4.49); and improvement on the Graves' ophthalmopathy QoL scale by at least 6 points for ""functioning"" (5/14 versus 8/13; RR 0.58, 95% CI 0.25 to 1.32), and ""appearance"" (9/14 versus 6/13; RR 1.39, 95% CI 0.69 to 2.82). Adverse events were more common in the RTX group (RR 1.39, 95% CI 0.90 to 2.13; low-certainty evidence). Minor adverse effects (mild infusion reactions) were observed in most people receiving RTX at first infusion. Two participants experienced a major infusion reaction, likely cytokine release syndrome. RTX compared to placebo One study, conducted in the USA, enrolled 25 participants with active TAO (CAS ≥ 4 out of 7), comparing RTX (13 participants) to placebo. We judged this study to be at low risk of bias in most domains, but it was stopped early due to recruitment issues. It provided very low-certainty evidence on the following outcomes at 24 weeks: CAS improvement by 2 or more points (4/13 RTX versus 3/12 placebo; RR 1.23, 95% CI 0.34 to 4.40); NOSPECS improvement by 2 or more classes (2/13 versus 2/12; RR 0.92, 95% CI 0.15 to 5.56); proptosis improvement by 2 mm or more (2/13 versus 4/12; RR 0.46, 95% CI 0.10 to 2.08); palpebral aperture median change (0 mm in RTX group, in both eyes separately, versus -0.5 mm and 0.5 mm in placebo group right and left eye, respectively); motility median diplopia score (3 versus 2.5); SF-12 physical component median score (45.9 versus 40.3) and mental component median score (52.8 versus 46.1). More participants in the RTX group experienced adverse effects (8/13 versus 3/12; RR 2.46, 95% CI 0.84 to 7.18).  AUTHORS' CONCLUSIONS: There is currently insufficient evidence to support the use of RTX in people with TAO. Future studies investigating RTX in people with active TAO may need to be multi-centre in order to recruit enough participants to make an adequate judgement on the efficacy and safety of this novel therapy.",2022,"More participants in the RTX group experienced adverse effects (8/13 versus 3/12; RR 2.46, 95% CI 0.84 to 7.18).  ","['22 February 2022', 'mean age of participants was 55 years and 77% were women', '25 participants with active TAO (CAS ≥ 4 out of 7), comparing RTX (13 participants) to', 'people with TAO']","['RTX', 'IVMP', 'Rituximab (RTX', 'methylprednisolone (IVMP', 'Rituximab', 'placebo or glucocorticoids', 'placebo']","['mental component median score', 'SF-12 physical component median score', 'motility median diplopia score', 'clinical activity score (CAS), NOSPECS severity scale, proptosis (mm), palpebral aperture (mm), extraocular motility (degrees or diplopia rating scale), quality of life and adverse effects', 'appearance', 'efficacy and safety', 'quality of life', 'Adverse events', 'CAS improvement', 'major infusion reaction, likely cytokine release syndrome', 'motility improvement', 'adverse effects', 'palpebral aperture median change', ""Graves' ophthalmopathy QoL scale"", 'risk ratio (RR', 'palpebral aperture improvement']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0012569', 'cui_str': 'Diplopia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015300', 'cui_str': 'Exophthalmos'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction to drug or medicament administered by infusion'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",25.0,0.517684,"More participants in the RTX group experienced adverse effects (8/13 versus 3/12; RR 2.46, 95% CI 0.84 to 7.18).  ","[{'ForeName': 'Swan', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Hamed Azzam', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Minakaran', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Ezra', 'Affiliation': 'Moorfields and UCL Institute of Ophthalmology BMRC, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009226.pub3']
2092,35702341,Facilitators and barriers for home-based monitoring to time frozen embryo transfers in IVF among women and healthcare providers.,"STUDY QUESTION


What are the facilitators and barriers concerning the implementation of home-based monitoring for natural cycle frozen embryo transfer (NC-FET) from the perspectives of patients and healthcare providers in the Netherlands?
SUMMARY ANSWER


The most important facilitator was optimal pregnancy chance for both the patients and healthcare providers, and the most important barriers were the risk of missing an ovulation for the patients and laboratory capacity for the healthcare providers.
WHAT IS KNOWN ALREADY


The share of FET cycles in IVF treatments is increasing and, therefore, it is important to optimize protocols for FET. Monitoring of ovulation, which is used in NC-FET, can be hospital-based (ultrasounds and ovulation triggering) or home-based (LH urine tests). Home-based monitoring has the advantage of being the most natural protocol for FET and provides the feeling of empowerment and discretion for patients. A systematic approach for the implementation of home-based monitoring has to start with an exploration of the perspectives of all stakeholders.
STUDY DESIGN SIZE DURATION


Stakeholders (patients and healthcare providers) involved in the implementation process in the Netherlands participated in the present study. Patients were represented by the Dutch Patient Organisation for Couples with Fertility Problems (FREYA) and healthcare providers were represented by gynaecologists and their society (The Netherlands Society of Obstetrics and Gynaecology), embryologists and their society (The Dutch Federation of Clinical Embryology) as well as fertility doctors. A panel of experts hypothesized on barriers and facilitators for the implementation of home-based monitoring during the proposal phase of the Antarctica-2 randomized controlled trial (RCT).
PARTICIPANTS/MATERIALS SETTING METHODS


All stakeholders were represented during the study. Two different questionnaires were developed in order to investigate facilitators and barriers for the patients and for healthcare providers. The facilitators and barriers were ranked on a scale of 1-10 with 10 being the most important. Based on our power analysis, we aimed for a minimum of 300 completed questionnaires for the patients and a minimum of 90 completed questionnaires for the healthcare providers. Facilitators and barriers were analysed using frequencies, mean (SD) and ranking.
MAIN RESULTS AND THE ROLE OF CHANCE


A total of 311 patients filled out the questionnaire of whom 86.8% underwent FET previously. The most important facilitator for the patients was to implement the strategy with the highest chance of pregnancy (mean 9.7; 95% CI 9.6-9.7) and the most important barrier was risk of missing ovulation (mean 8.4; 95% CI 8.2-8.6). A total of 96 healthcare providers filled out the questionnaire. According to healthcare providers, patients would accept the strategy when it causes less interference with their work and private life (mean 7.5; 95% CI 7.1-8.0) and has a low risk of missing the ovulation (mean 7.6; 95% CI 7.1-8.0). The most important facilitator for the implementation of home-based monitoring for healthcare providers was optimizing cumulative pregnancy rates (mean 8.1; 95% CI 7.7-8.4) and the most important barrier was the lack of laboratory capacity and flexibility (mean 6.4; 95% CI 5.8-7.0).
LIMITATIONS REASONS FOR CAUTION


Facilitators and barriers were selected based on expert opinion. Currently, there are no validated questionnaires that aim to assess facilitators and barriers for the implementation of treatments in fertility care.
WIDER IMPLICATIONS OF THE FINDINGS


During our study, we gained insight into barriers and facilitators for the implementation of home-based monitoring of NC-FET at an early phase. Early sharing and discussion of the results of this study with all stakeholders involved should stimulate a fast incorporation in guidelines, especially as key professionals in guideline development took part in this study. Also, based on our results, we can advise guideline developers to add tools to the guideline that may help overcome the implementation barriers.
STUDY FUNDING/COMPETING INTERESTS


The Antarctica-2 RCT is supported by a grant from the Netherlands Organisation for Health Research and Development (ZonMw 843002807). No authors have any competing interests to declare.
TRIAL REGISTRATION NUMBER


Trial NL6414 (NTR6590).",2022,"Currently, there are no validated questionnaires that aim to assess facilitators and barriers for the implementation of treatments in fertility care.
","['300 completed questionnaires for the patients and a minimum of 90 completed questionnaires for the healthcare providers', 'women and healthcare providers', 'Stakeholders (patients and healthcare providers) involved in the implementation process in the Netherlands participated in the present study', 'Patients were represented by the Dutch Patient Organisation for Couples with Fertility Problems (FREYA) and healthcare providers were represented by gynaecologists and their society (The Netherlands Society of Obstetrics and Gynaecology), embryologists and their society (The Dutch Federation of Clinical Embryology) as well as fertility doctors', '311 patients filled out the questionnaire of whom 86.8% underwent FET previously', '96 healthcare providers filled out the questionnaire']",[],"['cumulative pregnancy rates', 'laboratory capacity and flexibility ']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0278048', 'cui_str': 'Fertility problem'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205170', 'cui_str': 'Good'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0643582', 'cui_str': '11-(2-fluoroethyl)estradiol'}]",[],"[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",96.0,0.0906064,"Currently, there are no validated questionnaires that aim to assess facilitators and barriers for the implementation of treatments in fertility care.
","[{'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Zaat', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",Human reproduction open,['10.1093/hropen/hoac021']
2093,35702828,"Flexible Buprenorphine/Naloxone Model of Care for Reducing Opioid Use in Individuals With Prescription-Type Opioid Use Disorder: An Open-Label, Pragmatic, Noninferiority Randomized Controlled Trial.","OBJECTIVE


Extensive exposure to prescription-type opioids has resulted in major harm worldwide, calling for better-adapted approaches to opioid agonist therapy. The authors aimed to determine whether flexible take-home buprenorphine/naloxone is as effective as supervised methadone in reducing opioid use in prescription-type opioid consumers with opioid use disorder.
METHODS


This seven-site, pan-Canadian, 24-week, pragmatic, open-label, noninferiority, two-arm parallel randomized controlled trial involved treatment-seeking adults with prescription-type opioid use disorder. Participants were randomized in a 1:1 ratio to treatment with sublingual buprenorphine/naloxone (target dosage, 8 mg/2 mg to 24 mg/6 mg per day; flexible take-home dosing) or oral methadone (≈60-120 mg/day; closely supervised). The primary outcome was the proportion of opioid-free urine drug screens over 24 weeks (noninferiority margin, 15%). All randomized participants were analyzed, excluding one who died shortly after randomization, for the primary analysis (modified intention-to-treat analysis).
RESULTS


Of 272 participants recruited (mean age, 39 years [SD=11]; 34.2% female), 138 were randomized to buprenorphine/naloxone and 134 to methadone. The mean proportion of opioid-free urine drug screens was 24.0% (SD=34.4) in the buprenorphine/naloxone group and 18.5% (SD=30.5) in the methadone group, with a 5.6% adjusted mean difference (95% CI=-0.3, +∞). Participants in the buprenorphine/naloxone group had 0.47 times the odds (95% CI=0.24, 0.90) of being retained in the assigned treatment compared with those in the methadone group. Overall, 24 drug-related adverse events were reported (12 in the buprenorphine/naloxone group [N=8/138; 5.7%] and 12 in the methadone group [N=12/134; 9.0%]) and mostly included withdrawal, hypogonadism, and overdose.
CONCLUSIONS


The buprenorphine/naloxone flexible model of care was safe and noninferior to methadone in reducing opioid use among people with prescription-type opioid use disorder. This flexibility could help expand access to opioid agonist therapy and reduce harms in the context of the opioid overdose crisis.",2022,The buprenorphine/naloxone flexible model of care was safe and noninferior to methadone in reducing opioid use among people with prescription-type opioid use disorder.,"['people with prescription-type opioid use disorder', '272 participants recruited (mean age, 39 years [SD=11]; 34.2% female), 138 were randomized to', 'seeking adults with prescription-type opioid use disorder', 'Individuals With Prescription-Type Opioid Use Disorder']","['sublingual buprenorphine/naloxone', 'methadone', 'buprenorphine/naloxone', 'oral methadone', 'Flexible Buprenorphine/Naloxone Model of Care']","['adverse events', 'mean proportion of opioid-free urine drug screens', 'proportion of opioid-free urine drug screens', 'withdrawal, hypogonadism, and overdose']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1273860', 'cui_str': 'Prescription types'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191359', 'cui_str': '34.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}]",272.0,0.170615,The buprenorphine/naloxone flexible model of care was safe and noninferior to methadone in reducing opioid use among people with prescription-type opioid use disorder.,"[{'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Jutras-Aswad', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Ahamad', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruneau', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Fischer', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'T Cameron', 'Initials': 'TC', 'LastName': 'Wild', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Brissette', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Gagnon', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fikowski', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ledjiar', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Masse', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': 'M Eugenia', 'Initials': 'ME', 'LastName': 'Socias', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse).""}]",The American journal of psychiatry,['10.1176/appi.ajp.21090964']
2094,35702815,Differences in the diagnosis and treatment decisions for children in care compared to their peers: An experimental study on post-traumatic stress disorder.,"OBJECTIVES


Despite evidence of high rates of diagnosable mental health difficulties in children in care, there remains ongoing debate around the appropriateness of traditional diagnoses and treatments. The aim of this study was to quantitatively explore whether mental health diagnosis and treatment decision-making differed when a young person was identified as being in care, specifically focused on post-traumatic stress disorder (PTSD). PTSD is a trauma-specific mental health disorder with rates substantially higher in children in care versus their peers.
METHODS


Participants were 270 UK mental health professionals who completed an online survey. Participants were randomized to receive one of two vignettes, which were identical in their description of a teenage boy experiencing PTSD symptoms, except in one he was in foster care and in the other he lived with his mother. Participants were asked to select a primary diagnosis, treatment approach, and potential secondary diagnosis.
RESULTS


Professionals were twice as likely to choose a primary diagnosis of PTSD and a National Institute for Clinical Excellence (NICE)-recommended PTSD treatment when randomized to the mother vignette versus the foster carer vignette. Selecting PTSD as the primary diagnosis made clinicians three times more likely to select a NICE-recommended treatment for PTSD. Developmental trauma was the most common 'diagnosis' for both groups, although this led to different treatment decisions.
CONCLUSIONS


In the context of PTSD, we found children in care face diagnosis and treatment decision-making biases. Practice implications are discussed.",2022,"Developmental trauma was the most common 'diagnosis' for both groups, although this led to different treatment decisions.
","['Participants were 270 UK mental health professionals who completed an online survey', 'children in care']",['PTSD'],[],"[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0728735', 'cui_str': 'Child in care'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",[],270.0,0.0603827,"Developmental trauma was the most common 'diagnosis' for both groups, although this led to different treatment decisions.
","[{'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'McGuire', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Halligan', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meiser-Stedman', 'Affiliation': 'Department of Clinical Psychology & Psychological Therapies, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Durbin', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Hiller', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK.'}]",The British journal of clinical psychology,['10.1111/bjc.12379']
2095,35702731,"Autologous cellular therapy for cerebral palsy: a randomized, crossover trial.","We examined an autologous mononuclear-cell-therapy-based approach to treat cerebral palsy using autologous umbilical cord blood or bone-marrow-derived mononuclear cells. The primary objective was to determine if autologous cells are safe to administer in children with cerebral palsy. The secondary objectives were to determine if there was improvement in motor function of patients 12 months after infusion using the Gross Motor Function Measure and to evaluate impact of treatment on corticospinal tract microstructure as determined by radial diffusivity measurement. This Phase 1/2a trial was a randomized, blinded, placebo-controlled, crossover study in children aged 2-10 years of age with cerebral palsy enrolled between November 2013 and November 2016. Participants were randomized to 2:1 treatment:placebo. Treatment was either autologous bone-marrow-derived mononuclear cells or autologous umbilical cord blood. All participants who enrolled and completed their baseline visit planned to return for follow-up visits at 6 months, 12 months and 24 months after the baseline visit. At the 12-month post-treatment visit, participants who originally received the placebo received either bone-marrow-derived mononuclear cell or umbilical cord blood treatment. Twenty participants were included; 7 initially randomized to placebo, and 13 randomized to treatment. Five participants randomized to placebo received bone-marrow-derived mononuclear cells, and 2 received umbilical cord blood at the 12-month visit. None of the participants experienced adverse events related to the stem cell infusion. Cell infusion at the doses used in our study did not dramatically alter motor function. We observed concordant bilateral changes in radial diffusivity in 10 of 15 cases where each corticospinal tract could be reconstructed in each hemisphere. In 60% of these cases (6/10), concordant decreases in bilateral corticospinal tract radial diffusivity occurred post-treatment. In addition, 100% of unilateral corticospinal tract cases (3/3) exhibited decreased corticospinal tract radial diffusivity post-treatment. In our discordant cases ( n  = 5), directionality of changes in corticospinal tract radial diffusivity appeared to coincide with handedness. There was a significant improvement in corticospinal tract radial diffusivity that appears related to handedness. Connectivity strength increased in either or both pathways (corticio-striatal and thalamo-cortical) in each participant at 12 months post-treatment. These data suggest that both stem cell infusions are safe. There may be an improvement in myelination in some groups of patients that correlate with small improvements in the Gross Motor Function Measure scales. A larger autologous cord blood trial is impractical at current rates of blood banking. Either increased private banking or matched units would be required to perform a larger-scale trial.",2022,We observed concordant bilateral changes in radial diffusivity in 10 of 15 cases where each corticospinal tract could be reconstructed in each hemisphere.,"['cerebral palsy', 'children aged 2-10 years of age with cerebral palsy enrolled between November 2013 and November 2016', 'children with cerebral palsy', 'Twenty participants were included; 7 initially randomized to']","['Autologous cellular therapy', 'bone-marrow-derived mononuclear cell or umbilical cord blood treatment', 'autologous mononuclear-cell-therapy-based approach', 'autologous bone-marrow-derived mononuclear cells or autologous umbilical cord blood', 'autologous umbilical cord blood or bone-marrow-derived mononuclear cells', 'placebo']","['adverse events', 'directionality of changes in corticospinal tract radial diffusivity', 'Connectivity strength', 'motor function', 'corticospinal tract radial diffusivity', 'bilateral corticospinal tract radial diffusivity', 'corticospinal tract microstructure']","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]",5.0,0.293618,We observed concordant bilateral changes in radial diffusivity in 10 of 15 cases where each corticospinal tract could be reconstructed in each hemisphere.,"[{'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Cox', 'Affiliation': 'Department of Pediatric Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Juranek', 'Affiliation': 'Department of Pediatric Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kosmach', 'Affiliation': 'Department of Pediatric Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Thakur', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Dempsey', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Rennie', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Scott', 'Affiliation': 'Department of Pediatric Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': 'Department of Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Akshita', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Aertker', 'Affiliation': 'Department of Neurology, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Caplan', 'Affiliation': 'Department of Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Triolo', 'Affiliation': 'Department of Pediatric Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Savitz', 'Affiliation': 'Department of Neurology, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}]",Brain communications,['10.1093/braincomms/fcac131']
2096,35703367,Non-pharmacological interventions for sleep promotion in hospitalized children.,"BACKGROUND


Healthy sleep is an important component of childhood development. Changes in sleep architecture, including sleep stage composition, quantity, and quality from infancy to adolescence are a reflection of neurologic maturation. Hospital admission for acute illness introduces modifiable risk factors for sleep disruption that may negatively affect active brain development during a period of illness and recovery. Thus, it is important to examine non-pharmacologic interventions for sleep promotion in the pediatric inpatient setting.
OBJECTIVES


To evaluate the effect of non-pharmacological sleep promotion interventions in hospitalized children and adolescents on sleep quality and sleep duration, child or parent satisfaction, cost-effectiveness, delirium incidence, length of mechanical ventilation, length of stay, and mortality.
SEARCH METHODS


We searched CENTRAL, MEDLINE, Embase, CINAHL, three other databases, and three trials registers to December 2021. We searched Google Scholar, and two websites, handsearched conference abstracts, and checked reference lists of included studies.
SELECTION CRITERIA


Randomized controlled trials (RCTs) or quasi-RCTs, including cross-over trials, investigating the effects of any non-pharmacological sleep promotion intervention on the sleep quality or sleep duration (or both) of children aged 1 month to 18 years in the pediatric inpatient setting (intensive care unit [ICU] or general ward setting).
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed trial eligibility, evaluated risk of bias, extracted and synthesized data, and used the GRADE approach to assess certainty of evidence. The primary outcomes were changes in both objective and subjective validated measures of sleep in children; secondary outcomes were child and parent satisfaction, cost-effectiveness ratios, delirium incidence or delirium-free days at time of hospital discharge, duration of mechanical ventilation, length of hospital stay, and mortality.
MAIN RESULTS


We included 10 trials (528 participants; aged 3 to 22 years) in inpatient pediatric settings. Seven studies were conducted in the USA, two in Canada, and one in Brazil. Eight studies were funded by government, charity, or foundation grants. Two provided no information on funding. Eight studies investigated behavioral interventions (massage, touch therapy, and bedtime stories); two investigated physical activity interventions. Duration and timing of interventions varied widely. All studies were at high risk of performance bias due to the nature of the intervention, as participants, parents, and staff could not be masked to group assignment. We were unable to perform a quantitative synthesis due to substantial clinical heterogeneity. Behavioral interventions versus usual care Five studies (145 participants) provided low-certainty evidence of no clear difference between multicomponent relaxation interventions and usual care on objective sleep measures. Overall, evidence from single studies found no clear differences in daytime or nighttime sleep measures (33 participants); any sleep parameter (48 participants); or daytime or nighttime sleep or nighttime arousals (20 participants). One study (34 participants) reported no effect of massage on nighttime sleep, sleep efficiency (SE), wake after sleep onset (WASO), or total sleep time (TST) in adolescents with cancer. Evidence from a cross-over study in 10 children with burns suggested touch therapy may increase TST (391 minutes, interquartile range [IQR] 251 to 467 versus 331 minutes, IQR 268 to 373; P = 0.02); SE (76, IQR 53 to 90 versus 66, IQR 55 to 78; P = 0.04); and the number of rapid eye movement (REM) periods (4.5, IQR 2 to 5 versus 3.5, IQR 2 to 4; P = 0.03); but not WASO, sleep latency (SL), total duration of REM, or per cent of slow wave sleep. Four studies (232 participants) provided very low-certainty evidence on subjective measures of sleep. Evidence from single studies found that sleep efficiency may increase, and the percentage of nighttime wakefulness may decrease more over a five-day period following a massage than usual care (72 participants). One study (48 participants) reported an improvement in Children's Sleep Habits Questionnaire scores after discharge in children who received a multicomponent relaxation intervention compared to usual care. In another study, mean sleep duration per sleep episode was longer (23 minutes versus 15 minutes), and time to fall asleep was shorter (22 minutes versus 27 minutes) following a bedtime story versus no story (18 participants); and children listening to a parent-recorded story had longer SL than when a parent was present (mean 57.5 versus 43.5 minutes); both groups reported longer SL than groups who had a stranger-recorded story, and those who had no story and absent parents (94 participants; P < 0.001). In one study (34 participants), 87% (13/15) of participants felt they slept better following massage, with most parents (92%; 11/12) reporting they wanted their child to receive a massage again. Another study (20 participants) reported that parents thought the music, touch, and reading components of the intervention were acceptable, feasible, and had positive effects on their children (very low-certainty evidence). Physical activity interventions versus usual care One study (29 participants) found that an enhanced physical activity intervention may result in little or no improvement in TST or SE compared to usual care (low-certainty evidence). Another study (139 participants), comparing play versus no play found inconsistent results on subjective measures of sleep across different ages (TST was 49% higher for the no play groups in 4- to 7-year olds, 10% higher in 7- to 11-year olds, and 22% higher in 11- to 14-year olds). This study also found inconsistent results between boys and girls (girls in the first two age groups in the play group slept more than the no play group). No study evaluated child or parent satisfaction for behavioral interventions, or cost-effectiveness, delirium incidence or delirium-free days at hospital discharge, length of mechanical ventilation, length of hospital stay, or mortality for either behavioral or physical activity intervention.
AUTHORS' CONCLUSIONS


The included studies were heterogeneous, so we could not quantitatively synthesize the results. Our narrative summary found inconsistent, low to very low-certainty evidence. Therefore, we are unable to determine how non-pharmacologic sleep promotion interventions affect sleep quality or sleep duration compared with usual care or other interventions. The evidence base should be strengthened through design and conduct of randomized trials, which use validated and highly reliable sleep assessment tools, including objective measures, such as polysomnography and actigraphy.",2022,Behavioral interventions versus usual care Five studies (145 participants) provided low-certainty evidence of no clear difference between multicomponent relaxation interventions and usual care on objective sleep measures.,"['10 children with burns', 'adolescents with cancer', 'boys and girls (girls in the first two age groups in the play group slept more than the no play group', 'children aged 1 month to 18 years in the pediatric inpatient setting (intensive care unit [ICU] or general ward setting', 'hospitalized children and adolescents', '10 trials (528 participants; aged 3 to 22 years) in inpatient pediatric settings', 'hospitalized children']","['non-pharmacological sleep promotion interventions', 'Behavioral interventions', 'multicomponent relaxation interventions and usual care', 'multicomponent relaxation intervention', 'behavioral interventions (massage, touch therapy, and bedtime stories); two investigated physical activity interventions', 'Physical activity interventions', 'pharmacological sleep promotion intervention', 'enhanced physical activity intervention']","['daytime or nighttime sleep measures', 'subjective measures of sleep', 'mean sleep duration per sleep episode', 'sleep quality or sleep duration', 'nighttime sleep, sleep efficiency (SE), wake after sleep onset (WASO), or total sleep time (TST', 'changes in both objective and subjective validated measures of sleep in children; secondary outcomes were child and parent satisfaction, cost-effectiveness ratios, delirium incidence or delirium-free days at time of hospital discharge, duration of mechanical ventilation, length of hospital stay, and mortality', 'sleep stage composition, quantity, and quality', 'TST', 'percentage of nighttime wakefulness', 'time to fall asleep', 'daytime or nighttime sleep or nighttime arousals', ""Children's Sleep Habits Questionnaire scores"", 'children listening to a parent-recorded story had longer SL', 'number of rapid eye movement (REM) periods', 'cost-effectiveness, delirium incidence or delirium-free days at hospital discharge, length of mechanical ventilation, length of hospital stay, or mortality for either behavioral or physical activity intervention', 'WASO, sleep latency (SL), total duration of REM, or per cent of slow wave sleep', 'sleep quality and sleep duration, child or parent satisfaction, cost-effectiveness, delirium incidence, length of mechanical ventilation, length of stay, and mortality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0043030', 'cui_str': 'Wards, General'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",10.0,0.0661274,Behavioral interventions versus usual care Five studies (145 participants) provided low-certainty evidence of no clear difference between multicomponent relaxation interventions and usual care on objective sleep measures.,"[{'ForeName': 'Sapna R', 'Initials': 'SR', 'LastName': 'Kudchadkar', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Berger', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ruchit', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Barnes', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Twose', 'Affiliation': 'Welch Medical Library, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Tracie', 'Initials': 'T', 'LastName': 'Walker', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Riley', 'Initials': 'R', 'LastName': 'Mitchell', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jaehyun', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Anton', 'Affiliation': 'Welch Medical Library, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Naresh M', 'Initials': 'NM', 'LastName': 'Punjabi', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Miller School of Medicine, University of Miami, Miami, FL, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012908.pub2']
2097,35703814,Robotic vs Laparoscopic Ventral Hernia Repair with Intraperitoneal Mesh: 1-Year Exploratory Outcomes of the PROVE-IT Randomized Clinical Trial.,"BACKGROUND


Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have been demonstrated previously to have comparable 30-day outcomes in the PROVE-IT randomized clinical trial. Here we report our 1-year follow-up of enrolled patients to examine exploratory outcomes.
STUDY DESIGN


All patients enrolled in a previously published, registry-based, randomized trial investigating laparoscopic vs robotic ventral hernia repair with intraperitoneal mesh were reviewed. Several exploratory secondary outcomes were assessed: pain intensity (Patient-Reported Outcomes Measurement Information System [PROMIS 3a]), hernia-specific quality of life (Hernia-Specific Quality of Life Survey [HerQLes]), composite hernia recurrence, and reoperations.
RESULTS


A total of 95% (71 of 75) follow-up was achieved: 33 laparoscopic repairs and 38 robotic repairs. Median follow-up time was 12 months [interquartile range 10 to 12 months]. Following regression analysis adjusting for baseline scores, there was no difference in postoperative pain intensity at 1 year (p = 0.94). However, HerQLes scores increased by 12.0 more points following robotic repairs compared to laparoscopic counterparts (95% CI 1.3 to 22.7, p = 0.03). Composite hernia recurrence was 6% (2 of 33) for the laparoscopic cohort and 24% (9 of 38) for the robotic group (p = 0.04). There was no difference in rates of reoperation (p = 0.61).
CONCLUSIONS


Our exploratory analyses have identified potential differences in quality of life and recurrence, favoring the robotic and laparoscopic approaches, respectively. These findings warrant further study with larger patient cohorts to verify their potential significance.",2022,"There was no difference in rates of reoperation (p = 0.61).
",['A total of 95% (71 of 75) follow-up was achieved: 33 laparoscopic repairs and 38 robotic repairs'],"['Robotic vs Laparoscopic Ventral Hernia Repair with Intraperitoneal Mesh', 'laparoscopic vs robotic ventral hernia repair with intraperitoneal mesh', 'Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh']","['pain intensity (Patient-Reported Outcomes Measurement Information System [PROMIS 3a]), hernia-specific quality of life (Hernia-Specific Quality of Life Survey', 'composite hernia recurrence, and reoperations', 'HerQLes scores', 'quality of life and recurrence', 'rates of reoperation', 'Composite hernia recurrence', 'postoperative pain intensity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.546019,"There was no difference in rates of reoperation (p = 0.61).
","[{'ForeName': 'Clayton C', 'Initials': 'CC', 'LastName': 'Petro', 'Affiliation': 'From the Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, Cleveland, OH (Petro, Tu, Krpata, Beffa, Rosen, Prabhu).'}, {'ForeName': 'Jonah D', 'Initials': 'JD', 'LastName': 'Thomas', 'Affiliation': 'Department of Surgery, Massachusetts General Hospital, Boston, MA (Thomas).'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Tu', 'Affiliation': 'From the Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, Cleveland, OH (Petro, Tu, Krpata, Beffa, Rosen, Prabhu).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Krpata', 'Affiliation': 'From the Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, Cleveland, OH (Petro, Tu, Krpata, Beffa, Rosen, Prabhu).'}, {'ForeName': 'Lucas R', 'Initials': 'LR', 'LastName': 'Beffa', 'Affiliation': 'From the Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, Cleveland, OH (Petro, Tu, Krpata, Beffa, Rosen, Prabhu).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rosen', 'Affiliation': 'From the Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, Cleveland, OH (Petro, Tu, Krpata, Beffa, Rosen, Prabhu).'}, {'ForeName': 'Ajita S', 'Initials': 'AS', 'LastName': 'Prabhu', 'Affiliation': 'From the Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, Cleveland, OH (Petro, Tu, Krpata, Beffa, Rosen, Prabhu).'}]",Journal of the American College of Surgeons,['10.1097/XCS.0000000000000171']
2098,35703758,Tailored Motivational Interviewing in Adolescent HIV Clinics: Primary Outcome Analysis of a Stepped Wedge Implementation Trial.,"BACKGROUND


Youth continue to have the poorest outcomes along the HIV prevention and care continua. Motivational Interviewing (MI) may promote behavior change and reduce perceived stigma, but providers often demonstrate inadequate MI competence. This study tested Tailored Motivational Interviewing (TMI), a set of implementation strategies designed to improve MI competence in youth HIV providers.
SETTING


Ten HIV clinics in the Adolescent Trials Network for HIV/AIDS Interventions.
METHODS


In a stepped wedge design, 10 clinics (N = 151 providers) were randomized in 5 clusters every 3 months to receive TMI for a 12-month implementation period. Sites were rerandomized within each cluster to receive communities of practice guidance with or without internal facilitator support in the sustainment period. Standard patient assessments were coded every 3 months for 36 months.
RESULTS


Nesting was addressed using mixed-effects regression models, with random effects for providers and sites. TMI resulted in significantly improved MI competence over baseline. Despite small reductions in competence in the sustainment window, competence was still significantly improved over baseline, with no difference between the 2 sustainment conditions.
CONCLUSIONS


TMI may be an important tool to capacitate the HIV HealthForce to end the HIV epidemic in young people.",2022,"Despite small reductions in competence in the sustainment window, competence was still significantly improved over baseline, with no difference between the 2 sustainment conditions.
","['Ten HIV clinics in the Adolescent Trials Network for HIV/AIDS Interventions', 'youth HIV providers', 'Adolescent HIV Clinics', '10 clinics (N = 151 providers']","['Tailored Motivational Interviewing', 'Tailored Motivational Interviewing (TMI', 'TMI', 'Motivational Interviewing (MI']",['MI competence'],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",151.0,0.359941,"Despite small reductions in competence in the sustainment window, competence was still significantly improved over baseline, with no difference between the 2 sustainment conditions.
","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, Florida State University.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'MacDonell', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Todd', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University; and.'}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, Florida State University.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sheffler', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, Florida State University.'}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Fernandez', 'Affiliation': 'Department of Public Health, Nova South Eastern University, College of Osteopathic Medicine.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002967']
2099,35703711,Influence of the method for determining working length on the obturation level of primary molars.,"Efficient working length determination is essential for a successful endodontic treatment. The purpose of the present study was to evaluate whether the method for determining the working length of root canals (radiographic or electronic) influences the obturation level of primary molars. Thus, a controlled, triple-blind, randomized clinical trial was conducted. Sixty-four children aged 6 to 9 years with an indication for primary molar pulpectomy were included. Participants were divided into two groups according to the method used to determine the working length of the root canals: (G1) radiographic and (G2) using an electronic apex locator. The study had 3 operators: #1 performed the clinical procedures, except the electronic measurement; #2 performed radiographic measurement and final evaluation of obturation level; and #3 performed eligibility criteria and electronic measurement. Adequacy of obturation level was evaluated based on the final conventional radiography and it was recorded as acceptable or unacceptable (short or overfilled). Data were analyzed with repeated measures logistic regression. There was no difference between the obturation level of primary molars measured by radiographic and electronic methods (p > 0.05). The other investigated variables (age, tooth type, dental arch position, last instrumentation file, and canal location) also did not influence the obturation level (p > 0.05). In conclusion, both measurement methods resulted in similar adequacy of obturation level in primary molars after pulpectomy.",2022,There was no difference between the obturation level of primary molars measured by radiographic and electronic methods (p > 0.05).,"['Sixty-four children aged 6 to 9 years with an indication for primary molar pulpectomy were included', 'primary molars']",['working length of the root canals: (G1) radiographic and (G2) using an electronic apex locator'],"['similar adequacy of obturation level', 'obturation level of primary molars measured by radiographic and electronic methods', 'Adequacy of obturation level']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}]","[{'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",64.0,0.0876726,There was no difference between the obturation level of primary molars measured by radiographic and electronic methods (p > 0.05).,"[{'ForeName': 'Nashalie Andrade de', 'Initials': 'NA', 'LastName': 'Alencar', 'Affiliation': 'Universidade Federal de Santa Catarina - UFSC, Department of Dentistry , Florianopolis , SC , Brazil .'}, {'ForeName': 'Filipe Colombo', 'Initials': 'FC', 'LastName': 'Vitali', 'Affiliation': 'Universidade Federal de Santa Catarina - UFSC, Department of Dentistry , Florianopolis , SC , Brazil .'}, {'ForeName': 'Pablo Silveira', 'Initials': 'PS', 'LastName': 'Santos', 'Affiliation': 'Universidade Federal de Santa Catarina - UFSC, Department of Dentistry , Florianopolis , SC , Brazil .'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bolan', 'Affiliation': 'Universidade Federal de Santa Catarina - UFSC, Department of Dentistry , Florianopolis , SC , Brazil .'}, {'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Cardoso', 'Affiliation': 'Universidade Federal de Santa Catarina - UFSC, Department of Dentistry , Florianopolis , SC , Brazil .'}]",Brazilian oral research,['10.1590/1807-3107bor-2022.vol36.0086']
2100,35703706,Root canal length changes during mechanical preparation due to different cervical enlargement patterns.,"This study aimed to evaluate the root canal real length (RL) changes due to the mechanical instrumentation use with different flaring magnitudes. After access cavity, 60 mesial root canals of mandibular molars were randomly separated in three groups: Hyflex EDM (HF; #25/.12, #10/.05 e #25/~), Reciproc Blue (RB; R25), and MTwo (M2; #10/.04, #15/.05, #20/.06 e #25/.06). The RL was defined as the apical limit, and 2.5% sodium hypochlorite irrigating solution was chosen. After the access cavity (RL 1), cervical flaring (RL 2), and complete chemical-mechanical preparation (RL 3), the RL was evaluated. The RL was evaluated by a blind examiner with the aid of a microscope (16x) placing the endodontic file stop at the coronary reference. When comparing length measurements, the RL was shorter before instrumentation than that after instrumentation. A reduction of 0.65 mm (HF), 0.61 mm (RB), and 0.48 mm (M2) was observed. However, among groups, no statistical differences were found (p > 0.05). Under the conditions tested, it can be inferred that all mechanical systems provoked RL variations, which emphasizes the need for constant verification of the odontometry, mainly before root canal obturation.",2022,"A reduction of 0.65 mm (HF), 0.61 mm (RB), and 0.48 mm (M2) was observed.",['60 mesial root canals of mandibular molars'],['Hyflex EDM (HF'],['root canal real length (RL) changes'],"[{'cui': 'C0447375', 'cui_str': 'Mesial tooth root'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]",[],"[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0558203,"A reduction of 0.65 mm (HF), 0.61 mm (RB), and 0.48 mm (M2) was observed.","[{'ForeName': 'Jafra Carvalho', 'Initials': 'JC', 'LastName': 'Furtado', 'Affiliation': 'São Leopoldo Mandic University , School of Dentistry of Ceará , Fortaleza , CE , Brazil .'}, {'ForeName': 'Alinne Patierry Oliveira Pacifico', 'Initials': 'APOP', 'LastName': 'Feiosa', 'Affiliation': 'Universidade Federal do Ceará - UFCE, Faculty of Pharmacy, Dentisrtry and Nursing , Fortaleza , CE , Brazil .'}, {'ForeName': 'Nilton', 'Initials': 'N', 'LastName': 'Vivacqua-Gomes', 'Affiliation': 'São Leopoldo Mandic University , School of Dentistry of Ceará , Fortaleza , CE , Brazil .'}, {'ForeName': 'Ricardo Affonso', 'Initials': 'RA', 'LastName': 'Bernardes', 'Affiliation': 'Brazilian Dental Association , Taguatinga , DF , Brazil .'}, {'ForeName': 'Rodrigo Ricci', 'Initials': 'RR', 'LastName': 'Vivan', 'Affiliation': 'Universidade de São Paulo - USP, Bauru Dental School , Department of Dentistry, Endodontics and Dental Materials , Bauru , SP , Brazil .'}, {'ForeName': 'Marco Antônio Hungaro', 'Initials': 'MAH', 'LastName': 'Duarte', 'Affiliation': 'Universidade de São Paulo - USP, Bauru Dental School , Department of Dentistry, Endodontics and Dental Materials , Bauru , SP , Brazil .'}, {'ForeName': 'Bruno Carvalho de', 'Initials': 'BC', 'LastName': 'Vasconcelos', 'Affiliation': 'Universidade Federal do Ceará - UFCE, Faculty of Pharmacy, Dentisrtry and Nursing , Fortaleza , CE , Brazil .'}]",Brazilian oral research,['10.1590/1807-3107bor-2022.vol36.0080']
2101,35709237,Effects of piano music of different tempos on heart rate and autonomic nervous system during the recovery period after high-intensity exercise.,"PURPOSE


The present study attempted to explore the effects of different tempos of piano music on heart rate and autonomous nervous system during the recovery period after high-intensity exercise. In addition, the study analyzed the influence of different tempos on the recovery period of athletes to devise methods for accelerating fatigue recovery through piano music.
METHOD


A total of 57 college students majoring in physical education were selected as experimental subjects and were divided into three groups, namely Lento group (n = 20), Moderato group (n = 20), and Allegretto group (n = 20; only 17 students completed the experiment).
RESULTS


Under the same high-intensity exercise regimen, the three groups did not differ significantly in the body composition, high-intensity exercise ability, and time-domain variation indices, namely heart rate (HR), heart rate variability index parameters (p > .05). The time-domain variation analysis in the recovery period revealed significant differences in HR frequency domain indices among the groups exposed to different rhythms (p < .05).
CONCLUSION


Moderate-tempo piano music was the most effective in facilitating HR and autonomic nervous system recovery during the recovery period.",2022,"The time-domain variation analysis in the recovery period revealed significant differences in HR frequency domain indices among the groups exposed to different rhythms (p < .05).
","['57 college students majoring in physical education were selected as experimental subjects and were divided into three groups, namely Lento group (n\xa0=\xa020), Moderato group (n\xa0=\xa020), and Allegretto group (n\xa0=\xa020; only 17 students completed the experiment']",['piano music'],"['heart rate and autonomic nervous system', 'HR frequency domain indices', 'body composition, high-intensity exercise ability, and time-domain variation indices, namely heart rate (HR), heart rate variability index parameters', 'heart rate and autonomous nervous system']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027763', 'cui_str': 'Structure of nervous system'}]",57.0,0.0129842,"The time-domain variation analysis in the recovery period revealed significant differences in HR frequency domain indices among the groups exposed to different rhythms (p < .05).
","[{'ForeName': 'Biyun', 'Initials': 'B', 'LastName': 'Xue', 'Affiliation': 'School of Marxism, School of Music and Dance, Henan Normal University, Xinxiang, Henan, China.'}, {'ForeName': 'Jiameng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Education, Hainan Medical University, Haikou, Hainan, China.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12981']
2102,35709234,"Multichannel transcranial direct current stimulation over the left dorsolateral prefrontal cortex may modulate the induction of secondary hyperalgesia, a double-blinded cross-over study in healthy volunteers.","BACKGROUND


Central sensitization is thought to play a critical role in the development of chronic pain, and secondary mechanical hyperalgesia is considered one of its hall-mark features. Consequently, interventions capable of modulating its development could have important therapeutic value. Non-invasive neuromodulation of the left dorsolateral prefrontal cortex (DLPFC) has shown potential to reduce pain, both in healthy volunteers and in patients. Whether it can modulate the induction of central sensitization, however, is less well known.
OBJECTIVE


To determine whether multifocal transcranial direct current stimulation (tDCS) targeting the left DLPFC affects the development of secondary mechanical hyperalgesia.
METHODS


In this within-subjects, cross-over, double-blinded study, eighteen healthy volunteers participated in three experimental sessions. After 20 minutes of either anodal, cathodal, or sham multichannel tDCS over the left DLPFC, secondary mechanical hyperalgesia was induced using high-frequency electrical stimulation (HFS) of the volar forearm. We assessed intensity of perception to 128 mN mechanical pinprick stimuli at baseline and up to 240 minutes after HFS. We also mapped the area of mechanical hyperalgesia.
RESULTS


HFS resulted in a robust and unilateral increase in the intensity of perception to mechanical pinprick stimuli at the HFS arm, which was not different between tDCS stimulation conditions. However, the area of hyperalgesia was reduced after anodal tDCS compared to sham.
CONCLUSION


Anodal tDCS over the left DLPFC modestly modulates the size of the HFS-induced area of secondary mechanical hyperalgesia, suggesting that non-invasive neuromodulation targeting the left DLPFC may be a potential intervention to limit the development of central sensitization.",2022,We assessed intensity of perception to 128 mN mechanical pinprick stimuli at baseline and up to 240 minutes after HFS.,"['healthy volunteers and in patients', 'eighteen healthy volunteers', 'healthy volunteers']","['Anodal tDCS', 'Multichannel\xa0transcranial direct current stimulation', 'multifocal transcranial direct current stimulation (tDCS', 'anodal tDCS', 'anodal, cathodal, or sham multichannel tDCS']","['area of hyperalgesia', 'intensity of perception to 128 mN mechanical pinprick stimuli', 'intensity of perception to mechanical pinprick stimuli']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",18.0,0.143874,We assessed intensity of perception to 128 mN mechanical pinprick stimuli at baseline and up to 240 minutes after HFS.,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Steyaert', 'Affiliation': 'Institute of Neuroscience (IONS), Université catholique de Louvain (UCLouvain), Brussels, Belgium.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Lenoir', 'Affiliation': 'Institute of Neuroscience (IONS), Université catholique de Louvain (UCLouvain), Brussels, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""Lavand'homme"", 'Affiliation': 'Institute of Neuroscience (IONS), Université catholique de Louvain (UCLouvain), Brussels, Belgium.'}, {'ForeName': 'Emanuel N', 'Initials': 'EN', 'LastName': 'van den Broeke', 'Affiliation': 'Institute of Neuroscience (IONS), Université catholique de Louvain (UCLouvain), Brussels, Belgium.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Mouraux', 'Affiliation': 'Institute of Neuroscience (IONS), Université catholique de Louvain (UCLouvain), Brussels, Belgium.'}]",PloS one,['10.1371/journal.pone.0270047']
2103,35709207,Comparing the effects of multimedia and face-to-face pain management education on pain intensity and pain catastrophizing among patients with chronic low back pain: A randomized clinical trial.,"INTRODUCTION


Previous studies into Low Back Pain (LBP) assessed the effects of physical interventions or face-to-face (FTF) education mostly in western cultures. The present study aimed to compare the effects of multimedia and FTF pain management education (PME) on pain intensity and pain catastrophizing among participants with chronic LBP.
METHODS


This double-blind randomized controlled clinical trial was conducted on ninety participants with chronic LBP randomly allocated to either multimedia, FTF, or control groups. Participants in the multimedia group received PME through watching seven educational CDs at home and their counterparts in the FTF group received the same educations in seven weekly FTF educational sessions. Pain intensity (using a numerical rating scale) and pain catastrophizing (using the Pain Catastrophizing Scale) were assessed before, immediately after, and one month after the study intervention. The effects of the interventions were assessed using the repeated-measures multivariate analysis of variance (MANOVA). Effect size and minimal detectable change (MDC) were reported for both variables. The regression model used in the present study was Generalized Estimating Equations (GEE).
FINDINGS


The findings of MANOVA showed the significant effects of time on pain intensity and pain catastrophizing (P<0.001). The Tukey's test showed that before and immediately after the intervention, the mean scores of pain intensity and pain catastrophizing in the FTF and PME groups were significantly different from the control group (P<0.001 and P = 0.001, respectively). MDC did not show clinically significant changes in the mean score of pain intensity and GEE revealed significant difference among the groups.
CONCLUSION


The findings suggested that multimedia PME is as effective as FTF education in reducing pain intensity and pain catastrophizing among participants with LBP. Future studies into the effects of education on LBP are recommended to consider longitudinal designs, a reliable cutoff score for pain catastrophizing, and participants' physical ability.
IRCT REGISTRATION CODE


IRCT20180313039074N1.",2022,"MDC did not show clinically significant changes in the mean score of pain intensity and GEE revealed significant difference among the groups.
","['patients with chronic low back pain', 'participants with LBP', 'participants with chronic LBP', 'ninety participants with chronic LBP']","['multimedia, FTF', 'PME', 'multimedia and face-to-face pain management education', 'multimedia and FTF pain management education (PME', 'multimedia PME']","['Pain intensity (using a numerical rating scale) and pain catastrophizing (using the Pain Catastrophizing Scale', 'mean score of pain intensity and GEE', 'pain intensity and pain catastrophizing', 'Effect size and minimal detectable change (MDC', 'mean scores of pain intensity and pain catastrophizing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1276796', 'cui_str': 'Pain management education'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",90.0,0.0900201,"MDC did not show clinically significant changes in the mean score of pain intensity and GEE revealed significant difference among the groups.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shaygan', 'Affiliation': 'Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Jaberi', 'Affiliation': 'Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Roghayyeh', 'Initials': 'R', 'LastName': 'Firozian', 'Affiliation': 'Student Research Committee, Shiraz University of medical sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yazdani', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",PloS one,['10.1371/journal.pone.0269785']
2104,35704479,Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer.,"BACKGROUND


The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical cancer, anal cancer is preceded by high-grade squamous intraepithelial lesions (HSILs). Treatment for cervical HSIL reduces progression to cervical cancer; however, data from prospective studies of treatment for anal HSIL to prevent anal cancer are lacking.
METHODS


We conducted a phase 3 trial at 25 U.S. sites. Persons living with HIV who were 35 years of age or older and who had biopsy-proven anal HSIL were randomly assigned, in a 1:1 ratio, to receive either HSIL treatment or active monitoring without treatment. Treatment included office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod. The primary outcome was progression to anal cancer in a time-to-event analysis. Participants in the treatment group were treated until HSIL was completely resolved. All the participants underwent high-resolution anoscopy at least every 6 months; biopsy was also performed for suspected ongoing HSIL in the treatment group, annually in the active-monitoring group, or any time there was concern for cancer.
RESULTS


Of 4459 participants who underwent randomization, 4446 (99.7%) were included in the analysis of the time to progression to cancer. With a median follow-up of 25.8 months, 9 cases were diagnosed in the treatment group (173 per 100,000 person-years; 95% confidence interval [CI], 90 to 332) and 21 cases in the active-monitoring group (402 per 100,000 person-years; 95% CI, 262 to 616). The rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57% (95% CI, 6 to 80; P = 0.03 by log-rank test).
CONCLUSIONS


Among participants with biopsy-proven anal HSIL, the risk of anal cancer was significantly lower with treatment for anal HSIL than with active monitoring. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02135419.).",2022,"The rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57% (95% CI, 6 to 80; P = 0.03 by log-rank test).
","['4459 participants who underwent randomization, 4446 (99.7%) were included in the analysis of the time to progression to cancer', 'Persons living with HIV who were 35 years of age or older and who had biopsy-proven anal HSIL', 'persons living with the human immunodeficiency virus (HIV) than in the general population', 'participants with biopsy-proven anal HSIL', 'Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer']","['office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod', 'HSIL treatment or active monitoring without treatment']","['rate of progression to anal cancer', 'risk of anal cancer', 'progression to anal cancer in a time-to-event analysis']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C3805161', 'cui_str': 'Anal HSIL'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1735618', 'cui_str': 'Anal high grade squamous intraepithelial lesion'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0153446', 'cui_str': 'Malignant tumor of anus'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3215191', 'cui_str': 'Fluorouracil-containing product in cutaneous dose form'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0153446', 'cui_str': 'Malignant tumor of anus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",9.0,0.24476,"The rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57% (95% CI, 6 to 80; P = 0.03 by log-rank test).
","[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Palefsky', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Jeannette Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Jay', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Goldstone', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Darragh', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Hillary A', 'Initials': 'HA', 'LastName': 'Dunlevy', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Rosa-Cunha', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Arons', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Pugliese', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Vena', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wilkin', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Bucher', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stier', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Tirado Gomez', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Flowers', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Luis F', 'Initials': 'LF', 'LastName': 'Barroso', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Ronald T', 'Initials': 'RT', 'LastName': 'Mitsuyasu', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Shelly Y', 'Initials': 'SY', 'LastName': 'Lensing', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Logan', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Aboulafia', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Schouten', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'de la Ossa', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Levine', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Korman', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hagensee', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Atkinson', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Einstein', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Bernadette M', 'Initials': 'BM', 'LastName': 'Cracchiolo', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Grant B', 'Initials': 'GB', 'LastName': 'Ellsworth', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Brickman', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Berry-Lawhorn', 'Affiliation': 'From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E.), Montefiore Medical Center, Albert Einstein School of Medicine (R.L.), and Memorial Sloan Kettering Cancer Center (T.M.A.) - all in New York; University of Colorado School of Medicine, Aurora (H.A.D.); University of Miami School of Medicine, Miami (I.R.-C.); the Emmes Company, Rockland, MD (J.C.P., D.V.); Anal Dysplasia Clinic Midwest, Chicago (G.B.); Boston University School of Medicine, Boston (E.A.S.); University of Puerto Rico Comprehensive Cancer Center, San Juan (M.T.G.); Emory University School of Medicine, Atlanta (L.F.); Wake Forest University Health Sciences, Winston-Salem, NC (L.F.B.); University of California, Los Angeles Schools of Medicine (R.T.M.) and Nursing (D.W.), Los Angeles; Denver Public Health, Denver (J.L.); University of Washington School of Medicine (D.M.A., J.T.S.) and the Polyclinic, Virginia Mason Medical Center (J.O.) - both in Seattle; Capital Digestive Care, Washington, DC (J.D.K.); Louisiana State University School of Medicine, New Orleans (M.H.); and Rutgers New Jersey Medical School, Newark (M.H.E., B.M.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2201048']
2105,35704394,"Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines.","BACKGROUND


OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for ≈3-4 months. Small studies have suggested that >20 U doses may increase efficacy and duration of response for GLs.
OBJECTIVES


Evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs.
METHODS


This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale (FWS). Percentage of subjects with investigator-assessed ≥1-grade FWS improvement from baseline at maximum frown (responders) at week 24; estimated median duration of response; proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up Items 1-5; and treatment-emergent adverse events (TEAEs) were evaluated.
RESULTS


The modified intent-to-treat population (N=226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P<0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P<0.05 vs 20 U at week 24). FLSQ results indicated high subject satisfaction. TEAE incidence and severity did not exhibit a dose-response effect.
CONCLUSIONS


GL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20 U dose with no apparent impact on safety variables.",2022,20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20 U dose with no apparent impact on safety variables.,"['women with moderate or severe dynamic GLs', 'Subjects With Moderate to Severe Dynamic Glabellar Lines', '40, 60, and 80 U']","['onabotulinumtoxinA vs 20 U and placebo', 'OnabotulinumtoxinA', 'placebo', 'FLSQ']","['glabellar line (GL) severity', 'longer duration of response and higher patient-reported satisfaction', 'Safety, Pharmacodynamic Response, and Treatment Satisfaction', '≥1-grade FWS improvement', 'Facial Line Satisfaction Questionnaire (FLSQ', 'Allergan Facial Wrinkle Scale (FWS', 'Median duration of response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.143207,20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20 U dose with no apparent impact on safety variables.,"[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Joseph', 'Affiliation': 'Clinical Testing of Beverly Hills, Beverly Hills, CA, USA.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Maas', 'Affiliation': 'Plastic surgeon in private practice, San Francisco, CA, USA.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Palm', 'Affiliation': 'Dermatologist in private practice, Solana Beach, CA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lain', 'Affiliation': 'Dermatologist in private practice, Sanova Dermatology, Pflugerville, TX, USA.'}, {'ForeName': 'Dee Anna', 'Initials': 'DA', 'LastName': 'Glaser', 'Affiliation': 'Department of Dermatology, Saint Louis University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bruce', 'Affiliation': 'Dermatologist in private practice, Houston, TX, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Yoelin', 'Affiliation': 'Ophthalmologist in private practice, Newport Beach, CA, USA.'}, {'ForeName': 'Sue Ellen', 'Initials': 'SE', 'LastName': 'Cox', 'Affiliation': 'Dermatologic Surgeon in private practice, Chapel Hill, NC, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fagien', 'Affiliation': 'Oculoplastic Surgeon in private practice, Boca Raton, FL, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sangha', 'Affiliation': 'Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Maltman', 'Affiliation': 'Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Mitchell F', 'Initials': 'MF', 'LastName': 'Brin', 'Affiliation': 'Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.'}]",Aesthetic surgery journal,['10.1093/asj/sjac157']
2106,35704372,Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial.,"BACKGROUND


Mild traumatic brain injury (mTBI) and chronic pain often co-occur and worsen rehabilitation outcomes. There is a need for improved multimodal nonpharmacologic treatments that could improve outcomes for both conditions. Yoga is a promising activity-based intervention for mTBI and chronic pain, and neuromodulation through transcranial magnetic stimulation is a promising noninvasive, nonpharmacological treatment for mTBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory transcranial magnetic stimulation. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS may magnify the impacts of subsequently delivered interventions as compared to delivering those interventions alone and accordingly boost their impact on outcomes.
OBJECTIVE


The aim of this study is to (1) develop a combined iTBS+yoga intervention for mTBI and chronic pain, (2) assess the intervention's feasibility and acceptability, and (3) gather preliminary clinical outcome data on quality of life, function, and pain that will guide future studies.
METHODS


This is a mixed methods, pilot, open-labeled, within-subject intervention study. We will enroll 20 US military veteran participants. The combined iTBS+yoga intervention will be provided in small group settings once a week for 6 weeks. The yoga intervention will follow the LoveYourBrain yoga protocol-specifically developed for individuals with TBI. iTBS will be administered immediately prior to the LoveYourBrain yoga session. We will collect preliminary quantitative outcome data before and after the intervention related to quality of life (TBI-quality of life), function (Mayo-Portland Adaptability Index), and pain (Brief Pain Inventory) to inform larger studies. We will collect qualitative data via semistructured interviews focused on intervention acceptability after completion of the intervention.
RESULTS


This study protocol was approved by Edward Hines Jr Veterans Administration Hospital Institutional Review Board (Hines IRB 1573116-4) and was prospectively registered on ClinicalTrials.gov (NCT04517604). This study includes a Food and Drug Administration Investigational Device Exemption (IDE: G200195). A 2-year research plan timeline was developed. As of March 2022, a total of 6 veterans have enrolled in the study. Data collection is ongoing and will be completed by November 2022. We expect the results of this study to be available by October 2024.
CONCLUSIONS


We will be able to provide preliminary evidence of safety, feasibility, and acceptability of a novel combined iTBS and yoga intervention for mTBI and chronic pain-conditions with unmet treatment needs.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04517604; https://www.clinicaltrials.gov/ct2/show/NCT04517604.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/37836.",2022,"We will collect preliminary quantitative outcome data before and after the intervention related to quality of life (TBI-quality of life), function (Mayo-Portland Adaptability Index), and pain (Brief Pain Inventory) to inform larger studies.","['20 US military veteran participants', '6 veterans have enrolled in the study', 'Edward Hines Jr Veterans Administration Hospital Institutional Review Board (Hines IRB 1573116-4', 'Mild Traumatic Brain Injury and Chronic Pain', 'individuals with TBI']","['Combined Neuromodulation and Yoga Intervention', 'iTBS+yoga intervention', 'Intermittent theta burst stimulation (iTBS', 'iTBS', 'combined iTBS+yoga intervention']","['quality of life, function, and pain', 'quality of life (TBI-quality of life), function (Mayo-Portland Adaptability Index), and pain (Brief Pain Inventory']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337961', 'cui_str': ""Veteran's administration hospital""}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.311374,"We will collect preliminary quantitative outcome data before and after the intervention related to quality of life (TBI-quality of life), function (Mayo-Portland Adaptability Index), and pain (Brief Pain Inventory) to inform larger studies.","[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Krese', 'Affiliation': 'Brain Innovation Center, Shirley Ryan AbilityLab, Chicago, IL, United States.'}, {'ForeName': 'Kyla Z', 'Initials': 'KZ', 'LastName': 'Donnelly', 'Affiliation': 'LoveYourBrain Foundation, Norwich, VT, United States.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Etingen', 'Affiliation': 'Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Bender Pape', 'Affiliation': 'Research and Development Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Sarmistha', 'Initials': 'S', 'LastName': 'Chaudhuri', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Aaronson', 'Affiliation': 'Mental Health Service Line, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Rachana P', 'Initials': 'RP', 'LastName': 'Shah', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Dulal K', 'Initials': 'DK', 'LastName': 'Bhaumik', 'Affiliation': 'Research and Development Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Billups', 'Affiliation': 'Research and Development Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Bedo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Mary Terese', 'Initials': 'MT', 'LastName': 'Wanicek-Squeo', 'Affiliation': 'Recreation Therapy, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bobra', 'Affiliation': 'Department of Radiology, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Herrold', 'Affiliation': 'Research and Development Service, Edward Hines Jr Veterans Administration Hospital, Hines, IL, United States.'}]",JMIR research protocols,['10.2196/37836']
2107,35704352,High-Intensity Interval Training vs Moderate-Intensity Continuous Training for Women Undergoing Cardiovascular Rehabilitation.,,2022,,['Women Undergoing Cardiovascular Rehabilitation'],['High-Intensity Interval Training vs Moderate-Intensity Continuous Training'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0700431', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0176453,,"[{'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Van Iterson', 'Affiliation': 'Section of Preventive Cardiology and Rehabilitation, Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Miller Family Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Laffin', 'Affiliation': 'Section of Preventive Cardiology and Rehabilitation, Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Miller Family Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Section of Preventive Cardiology and Rehabilitation, Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Miller Family Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA cardiology,['10.1001/jamacardio.2022.1479']
2108,35704351,High-Intensity Interval Training vs Moderate-Intensity Continuous Training for Women Undergoing Cardiovascular Rehabilitation.,,2022,,['Women Undergoing Cardiovascular Rehabilitation'],['High-Intensity Interval Training vs Moderate-Intensity Continuous Training'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0700431', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0176453,,"[{'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Terada', 'Affiliation': 'Exercise Physiology and Cardiovascular Health Lab, Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Sol', 'Initials': 'S', 'LastName': 'Vidal-Almela', 'Affiliation': 'Exercise Physiology and Cardiovascular Health Lab, Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Reed', 'Affiliation': 'Exercise Physiology and Cardiovascular Health Lab, Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}]",JAMA cardiology,['10.1001/jamacardio.2022.1476']
2109,35704345,Rivaroxaban Monotherapy vs Combination Therapy With Antiplatelets on Total Thrombotic and Bleeding Events in Atrial Fibrillation With Stable Coronary Artery Disease: A Post Hoc Secondary Analysis of the AFIRE Trial.,"Importance


Appropriate regimens of antithrombotic therapy for patients with atrial fibrillation (AF) and coronary artery disease (CAD) have not yet been established.
Objective


To compare the total number of thrombotic and/or bleeding events between rivaroxaban monotherapy and combined rivaroxaban and antiplatelet therapy in such patients.
Design, Setting, and Participants


This was a post hoc secondary analysis of the Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease (AFIRE) open-label, randomized clinical trial. This multicenter analysis was conducted from February 23, 2015, to July 31, 2018. Patients with AF and stable CAD who had undergone percutaneous coronary intervention or coronary artery bypass grafting 1 or more years earlier or who had angiographically confirmed CAD not requiring revascularization were enrolled. Data were analyzed from September 1, 2020, to March 26, 2021.
Interventions


Rivaroxaban monotherapy or combined rivaroxaban and antiplatelet therapy.
Main Outcomes and Measures


The total incidence of thrombotic, bleeding, and fatal events was compared between the groups. Cox regression analyses were used to estimate the risk of subsequent events in the 2 groups, with the status of thrombotic or bleeding events that had occurred by the time of death used as a time-dependent variable.
Results


A total of 2215 patients (mean [SD] age, 74 [8.2] years; 1751 men [79.1%]) were included in the modified intention-to-treat analysis. The total event rates for the rivaroxaban monotherapy group (1107 [50.0%]) and the combination-therapy group (1108 [50.0%]) were 12.2% (135 of 1107) and 19.2% (213 of 1108), respectively, during a median follow-up of 24.1 (IQR, 17.3-31.5) months. The mortality rate was 3.7% (41 of 1107) in the monotherapy group and 6.6% (73 of 1108) in the combination-therapy group. Rivaroxaban monotherapy was associated with a lower risk of total events compared with combination therapy (hazard ratio, 0.62; 95% CI, 0.48-0.80; P < .001). Monotherapy was an independent factor associated with a lower risk of subsequent events compared with combination therapy. The mortality risk after a bleeding event (monotherapy, 75% [6 of 8]; combination therapy, 62.1% [18 of 29]) was higher than that after a thrombotic event (monotherapy, 25% [2 of 8]; combination therapy, 37.9% [11 of 29]).
Conclusions and Relevance


Rivaroxaban monotherapy was associated with lower risks of total thrombotic and/or bleeding events than combination therapy in patients with AF and stable CAD. Tapered antithrombotic therapy with a sole anticoagulant should be considered in these patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT02642419.",2022,"Rivaroxaban monotherapy was associated with a lower risk of total events compared with combination therapy (hazard ratio, 0.62; 95% CI, 0.48-0.80; P < .001).","['February 23, 2015, to July 31, 2018', 'patients with atrial fibrillation (AF) and coronary artery disease (CAD', '2215 patients (mean [SD] age, 74 [8.2] years; 1751 men [79.1%]) were included in the modified intention-to-treat analysis', 'Patients With Stable Coronary Artery Disease (AFIRE', 'such patients', 'Patients with AF and stable CAD who had undergone percutaneous coronary intervention or coronary artery bypass grafting 1 or more years earlier or who had angiographically confirmed CAD not requiring revascularization were enrolled', 'patients with AF and stable CAD', 'With Stable Coronary Artery Disease', 'Atrial Fibrillation']","['Rivaroxaban monotherapy', 'Monotherapy', 'rivaroxaban monotherapy and combined rivaroxaban and antiplatelet therapy', 'Rivaroxaban Monotherapy', 'Rivaroxaban monotherapy or combined rivaroxaban and antiplatelet therapy', 'antithrombotic therapy', 'Rivaroxaban', 'rivaroxaban monotherapy']","['thrombotic or bleeding events', 'total event rates', 'total thrombotic and/or bleeding events', 'lower risk of total events', 'Total Thrombotic and Bleeding Events', 'mortality rate', 'total number of thrombotic and/or bleeding events', 'Atrial Fibrillation and Ischemic Events', 'total incidence of thrombotic, bleeding, and fatal events', 'mortality risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2215.0,0.119695,"Rivaroxaban monotherapy was associated with a lower risk of total events compared with combination therapy (hazard ratio, 0.62; 95% CI, 0.48-0.80; P < .001).","[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Naito', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo Tokyo Koto Geriatric Medical Center, Koto-Ku, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kaikita', 'Affiliation': 'Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Kiyotake, Miyazaki, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Akao', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kyoto Medical Center, Fukakusa, Fushimi-Ku, Kyoto, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiovascular Medicine, Kitasato University School of Medicine, Minami-Ku, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Matoba', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Meguro-Ku, Tokyo, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University, Shinjuku-Ku, Tokyo, Japan.""}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Cardiovascular Center, Yokohama City University Medical Center, Minami-Ku, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Department of Cardiology Osaka Police Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of General and Community Medicine, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'Kumamoto University, Kumamoto, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2022.1561']
2110,35704343,High-Intensity Interval Training vs Moderate-Intensity Continuous Training for Women Receiving Cardiovascular Rehabilitation-Reply.,,2022,,['Women Receiving Cardiovascular Rehabilitation-Reply'],['High-Intensity Interval Training vs Moderate-Intensity Continuous Training'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0700431', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0108519,,"[{'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Khadanga', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Savage', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Ades', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Vermont, Burlington.'}]",JAMA cardiology,['10.1001/jamacardio.2022.1482']
2111,34282866,Fractional CO2 laser and vulvar lichen sclerosus: an alternative resource during maintenance therapy? A prospective study.,"BACKGROUND


Lichen sclerosus is an autoimmune dermatosis that in women typically involves vulvar area. This condition can strongly impact on the quality of life. To date, topical steroids are the most effective treatment, although adverse effects are possible, especially in long-term application. The aims of this study are: 1) to investigate the efficacy of fractional CO<inf>2</inf> laser in reducing symptoms of vulvar lichen sclerosus (VLS) during maintenance therapy with topical steroids (application twice weekly or less); 2) to assess how long this reduction of symptoms persists during follow-up; 3) histological comparison before and after treatment. To our knowledge, this is the first prospective study evaluating this treatment in women with VLS.
METHODS


Women with a diagnosis of VLS were prospectively enrolled and treated with fractional CO<inf>2</inf> laser every 2 months, for a total of 3 sessions. Four questionnaires were periodically administered: the Dermatology Quality of Life Index (DLQI), the Female Sexual Functional Index (FSFI) and two specific questionnaires created to assess the severity of disease.
RESULTS


Twenty-three adult women were enrolled. The fractional CO<inf>2</inf> laser treatment significantly improved the scores of all scales from baseline to T4 questionnaires.
CONCLUSIONS


Fractional CO<inf>2</inf> laser proved to be effective on VLS symptoms and can be considered an alternative to corticosteroids during maintenance therapy. Larger studies with a control group and randomization are needed to safely generalize our findings.",2022,"The fractional CO<inf>2</inf> laser treatment significantly improved the scores of all scales from baseline to T4 questionnaires.
","['Women with a diagnosis of VLS', 'Twenty-three adult women were enrolled', 'women typically involves vulvar area', 'women with VLS']","['Fractional CO2 laser and vulvar lichen sclerosus', 'fractional CO<inf>2</inf> laser', 'fractional CO<inf>2</inf', 'Fractional CO', 'topical steroids']","['quality of life', 'Dermatology Quality of Life Index (DLQI), the Female Sexual Functional Index (FSFI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0022783', 'cui_str': 'Lichen sclerosus et atrophicus of the vulva'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",23.0,0.0235566,"The fractional CO<inf>2</inf> laser treatment significantly improved the scores of all scales from baseline to T4 questionnaires.
","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ferrara', 'Affiliation': 'Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Filippi', 'Affiliation': 'Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy - federicafilippi8@gmail.com.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Messori', 'Affiliation': 'Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Iommi', 'Affiliation': 'Division of Hygiene and Biostatistics, Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Patrizi', 'Affiliation': 'Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': ""D'Antuono"", 'Affiliation': 'Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Gaspari', 'Affiliation': 'Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Chessa', 'Affiliation': 'Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Baraldi', 'Affiliation': 'Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bardazzi', 'Affiliation': 'Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.'}]",Italian journal of dermatology and venereology,['10.23736/S2784-8671.21.07066-3']
2112,34534293,Circulating levels of maternal vitamin D and risk of ADHD in offspring: results from the Vitamin D Antenatal Asthma Reduction Trial.,"BACKGROUND


Low levels of circulating 25-hydroxy-vitamin D [25(OH)D] have been shown to associate with prevalent attention-deficit/hyperactivity disorder (ADHD), but few studies have examined the association between 25(OH)D during fetal development and risk of childhood ADHD.
METHODS


Maternal plasma 25(OH)D was measured at 10-18 and 32-38 weeks of gestation, with sufficiency defined as 25(OH)D ≥ 30 ng/ml. Offspring ADHD status between ages 6-9 years was measured by parent report of clinical ADHD diagnosis among 680 mother-child pairs from the Vitamin D Antenatal Asthma Reduction Trial. Association between maternal 25(OH)D and child ADHD was assessed using logistic regression, adjusting for maternal age, race and ethnicity. Effect modification by offspring sex was also assessed.
RESULTS


No associations between maternal 25(OH)D at 10-18 weeks of gestation and offspring ADHD were observed. In the third trimester, we observed associations between maternal vitamin D sufficiency and offspring ADHD [odds ratio (OR) 0.47, 95% confidence interval (CI) 0.26-0.84], in addition to maternal 25(OH)D sufficiency category, comparing the deficient (OR 0.34, 95% CI 0.12-0.94), insufficient (OR 0.41, 95% CI 0.15-1.10) and sufficient (OR 0.20, 95% CI 0.08-0.54) categories against highly deficient 25(OH)D, respectively. Stratified analyses revealed a protective association for sufficient maternal 25(OH)D and child ADHD among males (OR 0.47, 95% CI 0.23-0.94); the synergy index for additive effect modification of risk was 1.78 (95% CI 0.62-5.08).
CONCLUSIONS


Higher levels of maternal vitamin D in the third trimester are associated with lower risk of ADHD in offspring, with modest evidence for a stronger effect among male offspring. However, larger studies will be necessary to confirm these findings.",2022,"Stratified analyses revealed a protective association for sufficient maternal 25(OH)D and child ADHD among males (OR 0.47, 95% CI 0.23-0.94); the synergy index for additive effect modification of risk was 1.78 (95% CI 0.62-5.08).
","['Maternal plasma 25(OH)D was measured at 10-18 and 32-38\u2009weeks of gestation, with sufficiency defined as 25(OH)D\u2009≥\u200930 ng/ml', '680 mother-child pairs from the Vitamin D Antenatal Asthma Reduction Trial']",['25-hydroxy-vitamin D [25(OH)D'],"['maternal 25(OH)D and child ADHD', 'maternal vitamin D', 'Circulating levels of maternal vitamin D and risk of ADHD', 'maternal vitamin D sufficiency and offspring ADHD']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",,0.198963,"Stratified analyses revealed a protective association for sufficient maternal 25(OH)D and child ADHD among males (OR 0.47, 95% CI 0.23-0.94); the synergy index for additive effect modification of risk was 1.78 (95% CI 0.62-5.08).
","[{'ForeName': 'Su H', 'Initials': 'SH', 'LastName': 'Chu', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Mengna', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Kelly', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Kachroo', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': 'Department of Pediatrics, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lasky-Su', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}]",International journal of epidemiology,['10.1093/ije/dyab194']
2113,35709414,Prognosis of Patients With Primary Melanoma Stage I and II According to American Joint Committee on Cancer Version 8 Validated in Two Independent Cohorts: Implications for Adjuvant Treatment.,"PURPOSE


The first randomized trial of adjuvant treatment with checkpoint inhibitor in stage II melanoma reported a significant reduction in risk of tumor recurrence. This study evaluates two independent data sets to further document survival probabilities for patients with primary stage I and II melanoma.
PATIENTS AND METHODS


The Central Malignant Melanoma Registry (CMMR) in Germany evaluated 17,544 patients with a primary diagnosis of stage I and II melanoma from 2000 to 2015. The exploratory cohort consisted of 6,725 patients from the Center for Dermato-Oncology at the University of Tübingen, and the confirmatory cohort consisted of 10,819 patients from 11 other German centers. Survival outcomes were compared with published American Joint Committee on Cancer version 8 (AJCCv8) stage I and II survival data.
RESULTS


For the two CMMR cohorts in stage IA compared with the AJCCv8 cohort, melanoma-specific survival rates at 10 years were 95.1%-95.6% versus 98%; 89.7%-90.9% versus 94% in stage IB; 80.7%-83.1% versus 88% in stage IIA; 72.0%-79.9% versus 82% in stage IIB; and 57.6%-64.7% versus 75% in stage IIC, respectively. Recurrence rates were approximately twice as high as melanoma-specific mortality rates in stages IA-IIA.
CONCLUSION


The melanoma-specific survival rates in the two CMMR cohorts across stages I and II are less favorable than published in AJCCv8. This has important implications for the consideration of adjuvant treatment in this population.",2022,"Recurrence rates were approximately twice as high as melanoma-specific mortality rates in stages IA-IIA.
","['6,725 patients from the Center for Dermato-Oncology at the University of Tübingen, and the confirmatory cohort consisted of 10,819 patients from 11 other German centers', 'patients with primary stage I and II melanoma', 'The Central Malignant Melanoma Registry (CMMR) in Germany evaluated 17,544 patients with a primary diagnosis of stage I and II melanoma from 2000 to 2015', 'Patients With Primary Melanoma Stage I and II']",['checkpoint inhibitor'],"['survival probabilities', 'Cancer version 8 (AJCCv8) stage I and II survival data', 'risk of tumor recurrence', 'Recurrence rates', 'Survival outcomes', 'melanoma-specific survival rates', 'melanoma-specific mortality rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",17544.0,0.609047,"Recurrence rates were approximately twice as high as melanoma-specific mortality rates in stages IA-IIA.
","[{'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, Center for Dermatooncology, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Keim', 'Affiliation': 'Department of Dermatology, Center for Dermatooncology, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Amaral', 'Affiliation': 'Department of Dermatology, Center for Dermatooncology, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Berking', 'Affiliation': 'Department of Dermatology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Eigentler', 'Affiliation': 'Department of Dermatology, Skin Cancer Center, Charité Berlin, Berlin, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Flatz', 'Affiliation': 'Department of Dermatology, Center for Dermatooncology, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Gesierich', 'Affiliation': 'Department of Dermatology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Leiter', 'Affiliation': 'Department of Dermatology, Center for Dermatooncology, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Stadler', 'Affiliation': 'Department of Dermatology, Johannes Wesling Hospital Minden, Ruhr-University of Bochum, Minden, Germany.'}, {'ForeName': 'Cord', 'Initials': 'C', 'LastName': 'Sunderkötter', 'Affiliation': 'Department of Dermatology and Venereology, University Hospital Halle, Halle, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tüting', 'Affiliation': 'Department of Dermatology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Utikal', 'Affiliation': 'Skin Cancer Unit, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Wollina', 'Affiliation': 'Department of Dermatology and Allergology, Municipal Hospital of Dresden, Dresden, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zimmer', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Christos C', 'Initials': 'CC', 'LastName': 'Zouboulis', 'Affiliation': 'Departments of Dermatology, Venereology, Allergology and Immunology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane and Faculty of Health Sciences Brandenburg, Dessau, Germany.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Princess Máxima Center, Utrecht, the Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancer Department, APHM Timone, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Lidija Kandolf', 'Initials': 'LK', 'LastName': 'Sekulovic', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Military Medical Academy, Belgrade, Serbia.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Mater Hospital, Sydney, Australia.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Luke', 'Affiliation': 'Cancer Immunotherapeutic Center of UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Michielin', 'Affiliation': 'Department of Medical Oncology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Ketty', 'Initials': 'K', 'LastName': 'Peris', 'Affiliation': 'Institute of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Melanoma and Skin Cancer Program, Hillman Cancer Research Pavilion Laboratory, University of Pittsburgh Cancer Institute, Pittsburgh, PA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Lorigan', 'Affiliation': 'Division of Cancer Sciences, The Christie NHS Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.22.00202']
2114,35709412,Metastatic Rhabdomyosarcoma: Results of the European  Paediatric  Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study.,"PURPOSE


Outcome for patients with metastatic rhabdomyosarcoma (RMS) is poor. This study presents the results of the MTS 2008 study with a pooled analysis including patients from the concurrent BERNIE study.
PATIENTS AND METHODS


In MTS 2008, patients with metastatic RMS received four cycles of ifosfamide, vincristine, and actinomycin D (IVA) plus doxorubicin, five cycles of IVA, and 12 cycles of maintenance chemotherapy (low-dose cyclophosphamide and vinorelbine). The BERNIE study randomly assigned patients to the addition or not of bevacizumab to the same chemotherapy. Local therapy (surgery/radiotherapy) was given to the primary tumor and all metastatic sites when feasible.
RESULTS


MTS 2008 included 270 patients (median age, 9.6 years; range, 0.07-20.8 years). With a median follow-up of 50.3 months, 3-year event-free survival (EFS) and overall survival (OS) were 34.9% (95% CI, 29.1 to 40.8) and 47.9% (95% CI, 41.6 to 53.9), respectively. In pooled analyses on 372 patients with a median follow-up of 55.2 months, 3-year EFS and OS were 35.5% (95% CI, 30.4 to 40.6) and 49.3% (95% CI, 43.9 to 54.5), respectively. Patients with ≤ 2 Oberlin risk factors (ORFs) had better outcome than those with ≥ 3 ORFs: 3-year EFS was 46.1% versus 12.5% ( P  < .0001) and 3-year OS 60.0% versus 26.0% ( P  < .0001). Induction chemotherapy and maintenance appeared tolerable; however, about two third of patients needed dose adjustments during maintenance.
CONCLUSION


Outcome remains poor for patients with metastatic RMS and multiple ORFs. Because of the design of the studies, it was not possible to determine whether the intensive induction regimen and/or the addition of maintenance treatment resulted in apparent improvement of outcome compared with historical cohorts. Further studies, with novel treatment approaches are urgently needed, to improve outcome for the group of patients with adverse prognostic factors.",2022,"With a median follow-up of 50.3 months, 3-year event-free survival (EFS) and overall survival (OS) were 34.9% (95% CI, 29.1 to 40.8) and 47.9% (95% CI, 41.6 to 53.9), respectively.","['patients with metastatic rhabdomyosarcoma (RMS', 'MTS 2008 included 270 patients (median age, 9.6 years; range, 0.07-20.8 years', 'patients with metastatic RMS and multiple ORFs', '372 patients with a median follow-up of 55.2 months', 'Metastatic Rhabdomyosarcoma']","['bevacizumab', 'Induction chemotherapy', 'ifosfamide, vincristine, and actinomycin D (IVA) plus doxorubicin, five cycles of IVA, and 12 cycles of maintenance chemotherapy (low-dose cyclophosphamide and vinorelbine', 'Local therapy (surgery/radiotherapy']","['3-year EFS and OS', '3-year event-free survival (EFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C0796074', 'cui_str': 'Deafness-dystonia-optic neuronopathy syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4518239', 'cui_str': '0.07'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",270.0,0.105824,"With a median follow-up of 50.3 months, 3-year event-free survival (EFS) and overall survival (OS) were 34.9% (95% CI, 29.1 to 40.8) and 47.9% (95% CI, 41.6 to 53.9), respectively.","[{'ForeName': 'Reineke A', 'Initials': 'RA', 'LastName': 'Schoot', 'Affiliation': 'Princess Máxima Centre for Paediatric Oncology, Utrecht, the Netherlands.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Chisholm', 'Affiliation': 'Children and Young Peoples Unit, Royal Marsden Hospital and Institute of Cancer Research, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Casanova', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': 'Gustave-Roussy Cancer Campus, Department of Paediatric and Adolescent Oncology, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Geoerger', 'Affiliation': 'Gustave-Roussy Cancer Campus, Department of Paediatric and Adolescent Oncology, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Cameron', 'Affiliation': 'Bristol Haematology and Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Coppadoro', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Zanetti', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Orbach', 'Affiliation': 'SIREDO Oncology Center, Institut Curie, PSL University, Paris, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kelsey', 'Affiliation': ""Department of Paediatric Histopathology, Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Rogers', 'Affiliation': 'Department of Pediatric Surgery, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Guizani', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Elze', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Ben-Arush', 'Affiliation': ""Joan and Sanford Weill Pediatric Hematology Oncology and Bone Marrow Transplantation Division, Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel.""}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'McHugh', 'Affiliation': 'Department of Radiology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Rick R', 'Initials': 'RR', 'LastName': 'van Rijn', 'Affiliation': ""Department of Radiology and Nuclear Medicine, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, the Netherlands.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Ferman', 'Affiliation': 'Instituto Nacional de Câncer, Pediatric Oncology Department, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Gallego', 'Affiliation': ""Pediatric Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Meriel', 'Initials': 'M', 'LastName': 'Jenney', 'Affiliation': ""Department of Paediatric Oncology, Children's Hospital for Wales, Heath Park, Cardiff, United Kingdom.""}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Johannes H M', 'Initials': 'JHM', 'LastName': 'Merks', 'Affiliation': 'Princess Máxima Centre for Paediatric Oncology, Utrecht, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.02981']
2115,35709376,"Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis, a Randomised, Controlled, Non-inferiority Trial.","BACKGROUND AND AIMS


Proctitis is the least extensive type of ulcerative colitis, for which rectal therapy is rarely studied and underused. This study evaluated the efficacy, safety, and patient's preference of a novel formulation of budesonide suppository 4 mg, compared with a commercially available budesonide rectal foam 2 mg, for the treatment of mild to moderate ulcerative proctitis.
METHODS


This was a randomised, double-blind, double-dummy, active-controlled trial. Patients were randomly assigned in a 1:1 ratio to receive either budesonide 4 mg suppository or budesonide 2 mg foam once daily for 8 weeks. The co-primary endpoints were changes from baseline to week 8 in clinical symptoms, for which clinical remission was defined as having a modified Ulcerative Colitis-Disease Activity Index (UC-DAI) subscore for stool frequency of 0 or 1 and a subscore for rectal bleeding of 0, and mucosal healing, defined as having a modified UC-DAI subscore for mucosal appearance of 0 or 1. Using a more stringent criterion we additionally analysed deepened mucosal healing, which was defined as a mucosal appearance subscore of 0. Patient's preference, physician's global assessment, and quality of life were also assessed and analysed.
RESULTS


Overall, 286 and 291 patients were included in the 4 mg suppository and 2 mg foam groups, respectively. Budesonide 4 mg suppository met the prespecified criterion for non-inferiority to the 2 mg foam in both co-primary endpoints of clinical remission and mucosal healing. Secondary endpoints consistently supported the non-inferiority of the suppository. Trends in favour of the suppository were observed in the subgroup of mesalazine non-responders. More patients reported a preference for the suppository over rectal foam.
CONCLUSIONS


In patients with ulcerative proctitis, budesonide 4 mg suppository was non-inferior to budesonide 2 mg foam in efficacy, and both were safe and well tolerated. EudraCT no. 2016-001921-15.",2022,"In patients with ulcerative proctitis, budesonide 4 mg suppository was non-inferior to budesonide 2 mg foam in efficacy, and both were safe and well tolerated.","['mild to moderate ulcerative proctitis', 'Active Ulcerative Proctitis', '286 and 291 patients', 'patients with ulcerative proctitis']","['budesonide 4 mg suppository', 'mesalazine', 'budesonide suppository', 'Novel Budesonide Suppository and Standard Budesonide Rectal Foam', 'budesonide 4 mg suppository or budesonide', 'Budesonide', 'budesonide', 'EudraCT']","['Clinical Remission and Mucosal Healing', 'safe and well tolerated', 'non-inferiority of the suppository', 'clinical symptoms, for which clinical remission was defined as having a modified Ulcerative Colitis-Disease Activity Index (UC-DAI) subscore for stool frequency of 0 or 1 and a subscore for rectal bleeding of 0, and mucosal healing', ""Patient's preference, physician's global assessment, and quality of life"", 'clinical remission and mucosal healing']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2937222', 'cui_str': 'Chronic ulcerative proctitis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3865068', 'cui_str': 'Budesonide Rectal Foam [Uceris]'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.357049,"In patients with ulcerative proctitis, budesonide 4 mg suppository was non-inferior to budesonide 2 mg foam in efficacy, and both were safe and well tolerated.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kruis', 'Affiliation': 'Emeritus Head of Gastroenterology, Ev. Krankenhaus Kalk, University of Cologne, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Siegmund', 'Affiliation': 'Department for Gastroenterology, Infectious diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Lesniakowski', 'Affiliation': 'Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego, Wroclaw, Poland.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Simanenkov', 'Affiliation': 'State Budgetary Healthcare Institution ""City Hospital #26"", Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Ludmila', 'Initials': 'L', 'LastName': 'Khimion', 'Affiliation': 'Municipal Institution of Kyiv Regional Rada ""Kyiv Regional Clinical Hospital"", Kyiv, Ukraine.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Sobon', 'Affiliation': 'Centrum Medyczne Pratia Bydgoszcz, Bydgoszcz, Poland.'}, {'ForeName': 'Glebs', 'Initials': 'G', 'LastName': 'Delmans', 'Affiliation': 'Daugavpils Regional Hospital, Daugavpils, Latvia.'}, {'ForeName': 'Svetlana V', 'Initials': 'SV', 'LastName': 'Maksyashina', 'Affiliation': 'State Public Health Institution ""Novgorod regional clinical hospital"", Velikiy Novgorod, Russian Federation.'}, {'ForeName': 'Oleg A', 'Initials': 'OA', 'LastName': 'Sablin', 'Affiliation': 'Federal State Budget Public Health Institution All-Russian centre of Emergency and Radiation medicine n. a., A.M.Nikiforov of Ministry of Emergency Situations of Russia, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Juris', 'Initials': 'J', 'LastName': 'Pokrotnieks', 'Affiliation': 'Pauls Stradins Clinical University Hospital / Gastroenterology, Hepatology and Nutrition Centre, Riga, Latvia.'}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Mostovoy', 'Affiliation': 'Private small-scale enterprise, Medical center ""Pulse"", Vinnitsya, Ukraine.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Datsenko', 'Affiliation': 'Municipal Institution of Healthcare ""Prof. Shalimova Kharkiv City Clinical Hospital # 2"", Kharkiv, Ukraine.'}, {'ForeName': 'Sayar', 'Initials': 'S', 'LastName': 'Abdulkhakov', 'Affiliation': 'Federal State Budget Educational Institution of High Education ""Kazan State Medical University"", Kazan, Russian Federation.'}, {'ForeName': 'Andriy', 'Initials': 'A', 'LastName': 'Dorofeyev', 'Affiliation': 'Ukrainian-German Gastroenterology Center ""BYK-Kyiv"", Kyiv, Ukraine.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Levchenko', 'Affiliation': 'Municipal Institution ""Odesa Regional Clinical Hospital"", Polyclinic department, Odesa, Ukraine.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Alexeeva', 'Affiliation': 'State Public Health Institution ""Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko"", Nizhny Novgorod, Russian Federation.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Andreev', 'Affiliation': 'Non-state Public Health Institution ""Railway clinical hospital on station Samara"" of JSC ""Russian railways"", Samara, Russian Federation.'}, {'ForeName': 'Ivan P', 'Initials': 'IP', 'LastName': 'Kolesnik', 'Affiliation': 'Municipal Institution ""Zaporizhzhya City Clinical Hospital of Urgent Care"", Surgery department #3, Zaporizhya, Ukraine.'}, {'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Mihaly', 'Affiliation': 'Semmelweis Egyetem ÁOK, II. Belgyógyászati Klinika, Budapest, Hungary.'}, {'ForeName': 'Orest', 'Initials': 'O', 'LastName': 'Abrahamovych', 'Affiliation': 'Lviv Regional Clinical Hospital, Gastroenterology department; Danylo Halytsky Lviv National Medical University, internal medicine chair #1, Lviv, Ukraine.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Baluta', 'Affiliation': 'Centrum Medyczne Pratia Gdynia, Gdynia, Poland.'}, {'ForeName': 'Nataliia', 'Initials': 'N', 'LastName': 'Kharchenko', 'Affiliation': 'Kyiv City Clinical Hospital #8, Department of Gastroenterology. P.L. Shupyk National Medical Academy of Post- graduate Education, Chair of Gastroenterology, Dietology and Endoscopy, Kyiv, Ukraine.'}, {'ForeName': 'Viacheslav', 'Initials': 'V', 'LastName': 'Neshta', 'Affiliation': 'Municipal Institution ""City Hospital #1"", Surgery department, Zaporizhya, Ukraine.'}, {'ForeName': 'Yury', 'Initials': 'Y', 'LastName': 'Uspenskiy', 'Affiliation': 'Saint-Petersburg State Public Health Institution ""City Hospital of Saint Venerable Martyr Elizabeth"", Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vieth', 'Affiliation': 'Friedrich-Alexander-University Erlangen-Nuremberg, Klinikum Bayreuth, Institute of Pathology, , Bayreuth, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Mohrbacher', 'Affiliation': 'Dr. Falk Pharma GmbH, Clinical Research and Development, Freiburg, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Mueller', 'Affiliation': 'Dr. Falk Pharma GmbH, Clinical Research and Development, Freiburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Greinwald', 'Affiliation': 'Dr. Falk Pharma GmbH, Clinical Research and Development, Freiburg, Germany.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjac081']
2116,35709575,A randomized clinical trial of the effects of brief versus extended opioid overdose education on naloxone utilization outcomes by individuals with opioid use disorder.,"BACKGROUND


Overdose education and naloxone distribution (OEND) trains people who use opioids (PWUO) in how to intervene in cases of opioid overdose but best practices have not been assessed empirically.
METHODS


PWUO along with a significant other (SO) were randomized to one of three training conditions. In the Treatment-as-Usual (TAU) condition, participants were randomized to receive minimal overdose-related education. In the extended training (ET) condition, PWUO received an extended training, while their SO received no overdose training. In the final condition, both the participant and SO received the extended overdose training (ETwSO). Outcome measures were naloxone use and overdose knowledge and competency assessed immediately before and after training, and at 1-, 3-, 6-, and 12-month timepoints following training.
RESULTS


Three hundred and twenty-one PWUO (w/ a SO) were randomized. All intensities of OD training were associated with sustained increases in OD knowledge/ competency (versus pre-training baseline p's < 0.01). PWUO intervened in 166 ODs. The 12-month incidence of naloxone use did not significantly differ between groups. Extended training (ET + ETwSO) compared to TAU resulted in significantly greater naloxone utilization by: 30 days (10.1% vs 4.1%, p = 0.041), 60 days (16.4% vs 5.2%, p<0.001) and 90 days (17.9% vs 9.5%, p = 0.039).
CONCLUSIONS


All intensities of OD training were associated with sustained increases in OD knowledge and competency, and equivalent rates of successful naloxone use. More extensive training increased naloxone utilization during the first 3 months. However, the benefits of more comprehensive training should be balanced against feasibility.",2022,"All intensities of OD training were associated with sustained increases in OD knowledge and competency, and equivalent rates of successful naloxone use.","['Three hundred and twenty-one PWUO (w', 'individuals with opioid use disorder']","['minimal overdose-related education', 'naloxone', 'brief versus extended opioid overdose education', 'extended training (ET) condition, PWUO received an extended training, while their SO received no overdose training', 'TAU']","['OD knowledge and competency, and equivalent rates of successful naloxone use', 'OD knowledge/ competency', 'naloxone utilization', 'naloxone use and overdose knowledge and competency assessed immediately before and after training']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0177019,"All intensities of OD training were associated with sustained increases in OD knowledge and competency, and equivalent rates of successful naloxone use.","[{'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA. Electronic address: jermainedjones@gmail.com.'}, {'ForeName': 'Aimee N', 'Initials': 'AN', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA.'}, {'ForeName': 'Verena E', 'Initials': 'VE', 'LastName': 'Metz', 'Affiliation': 'Kaiser Permanente Division of Research, Center for Addiction and Mental Health Research, 2000 Broadway, Oakland, CA 94612, USA.'}, {'ForeName': 'Suky', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wall', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Corbeil', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Andrews', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Castillo', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London SE5 8BB, United Kingdom.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London SE5 8BB, United Kingdom.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Ross', 'Affiliation': 'Addictive Disorders and Experimental Therapeutics Research Laboratory, New York University Langone Health, New York, NY 10016, USA.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109505']
2117,35709551,Effects of a multifaceted neurological assessment educational program in nursing students: A randomized crossover study.,"AIM


This study aimed to verify the effects of a multifaceted neurological assessment educational program on neurological assessment-related knowledge, skills, communication ability and self-efficacy in nursing students.
BACKGROUND


Nurses should be equipped with optimal neurological assessment competency to ensure quality care for patients with neurological symptoms.
DESIGN


This study involved a waitlist control group with a randomized crossover design.
METHODS


Fourth-year nursing students were randomly assigned to an intervention group (n = 28) or a waitlist control group (n = 27). Pre- and post-intervention differences in neurological assessment knowledge, skills, communication ability and self-efficacy between the intervention and the waitlist control group were analyzed using generalized estimated equations.
RESULTS


The nursing students in the intervention group showed significantly improved knowledge, skills, communication ability and self-efficacy scores compared with those in the waitlist control group. Scores related to knowledge, skills and communication ability were maintained and self-efficacy scores had further increased at 2 weeks after the educational program in the intervention group.
CONCLUSIONS


Our multifaceted neurological assessment educational program is useful for improving nursing students' knowledge, skills, communication ability and self-efficacy.",2022,"Scores related to knowledge, skills and communication ability were maintained and self-efficacy scores had further increased at 2 weeks after the educational program in the intervention group.
","['Fourth-year nursing students', 'patients with neurological symptoms', 'nursing students']","['waitlist control group', 'multifaceted neurological assessment educational program']","['knowledge, skills, communication ability and self-efficacy scores', 'neurological assessment-related knowledge, skills, communication ability and self-efficacy', 'knowledge, skills and communication ability were maintained and self-efficacy scores', 'neurological assessment knowledge, skills, communication ability and self-efficacy']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0565998', 'cui_str': 'Ability to communicate'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",,0.0086019,"Scores related to knowledge, skills and communication ability were maintained and self-efficacy scores had further increased at 2 weeks after the educational program in the intervention group.
","[{'ForeName': 'Ki Sook', 'Initials': 'KS', 'LastName': 'Bae', 'Affiliation': 'Department of Nursing, Jinju Health College, 51, Uibyeong-ro, Jinju-si, Gyeongsangnam-do 52655, Republic of Korea. Electronic address: nari77kr@naver.com.'}, {'ForeName': 'Young Sook', 'Initials': 'YS', 'LastName': 'Roh', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, 84 Heukseok-ro Dongjak-gu, Seoul 06974, Republic of Korea. Electronic address: aqua@cau.ac.kr.'}]",Nurse education in practice,['10.1016/j.nepr.2022.103378']
2118,35709548,A randomized controlled trial examining the effects of intranasal oxytocin on alcohol craving and intimate partner aggression among couples.,"BACKGROUND


While alcohol use disorder (AUD) is a well-established risk factor for intimate partner aggression (IPA), effective treatments for co-occurring AUD and IPA (AUD/IPA) are lacking. Oxytocin is one promising pharmacological candidate for AUD/IPA given its potential to modulate social behavior and attenuate alcohol use. However, emerging data suggests that oxytocin's prosocial effects are inconsistent, and a small number of studies have also found that oxytocin might have the potential to be aggressogenic. No studies have directly examined the impact of oxytocin on alcohol- or IPA-related outcomes in a dyadic context.
METHODS


The goal of this double-blind, randomized, and placebo-controlled trial was to examine the effects of a single dose of intranasal oxytocin (40 international units) on cue-induced alcohol craving, subjective aggression, laboratory task-based IPA, and cortisol reactivity in a sample of 100 couples (N = 200 individuals) with AUD and physical IPA in their current relationship.
RESULTS


There were no statistically significant differences between the oxytocin and placebo conditions for any of the primary outcomes.
CONCLUSIONS


Findings suggest that a single dose of intranasal oxytocin was not efficacious in mitigating alcohol craving or aggression in this sample. Although hypotheses were not supported, the findings provide important evidence that oxytocin was not aggressogenic in this high-risk sample. Future research investigating dispositional and contextual moderators of oxytocin response in addition to the therapeutic effects of more intensive oxytocin dosing or administration strategies on alcohol craving and aggression is warranted.",2022,"There were no statistically significant differences between the oxytocin and placebo conditions for any of the primary outcomes.
","['100 couples (N\xa0=\xa0200 individuals) with AUD and physical IPA in their current relationship', 'couples']","['placebo', 'Oxytocin', 'intranasal oxytocin', 'oxytocin']","['alcohol craving and aggression', 'alcohol craving or aggression', 'cue-induced alcohol craving, subjective aggression, laboratory task-based IPA, and cortisol reactivity', 'alcohol craving and intimate partner aggression']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",100.0,0.187773,"There were no statistically significant differences between the oxytocin and placebo conditions for any of the primary outcomes.
","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: Hellmuth@musc.edu.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Nietert', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Sippel', 'Affiliation': 'VA Northeast Program Evaluation Center, West Haven, CT, USA; Department of Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, NH, USA; National Center for PTSD Evaluation Division, West Haven, CT, USA.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Charli', 'Initials': 'C', 'LastName': 'Kirby', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jasara N', 'Initials': 'JN', 'LastName': 'Hogan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Massa', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brower', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Parrott', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, Georgia, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.06.011']
2119,35709509,"Efficacy of a Novel Injection Lipolysis to Induce Targeted Adipocyte Apoptosis: A Randomized, Phase IIa Study of CBL-514 Injection on Abdominal Subcutaneous Fat Reduction.","BACKGROUND


CBL-514 is a novel injectable drug that may be safe and efficacious for localized abdominal subcutaneous fat reduction.
OBJECTIVES


To assess the safety and efficacy of CBL-514 in reducing abdominal subcutaneous fat volume and thickness.
METHODS


This Phase IIa, open-label, random allocation study consisted of a 6-week treatment period and follow-up at 4- and 8-weeks following the last treatment. Participants were randomly allocated to 1.2 mg/cm 2 (180 mg), 1.6 mg/cm 2 (240 mg), or 2.0 mg/cm 2 (300 mg) of CBL-514 with up to 4 treatments, each with 60 injections into the abdominal adipose layer. Changes in abdominal subcutaneous fat were assessed by ultrasound at follow-up visits. Treatment-emergent adverse events were recorded.
RESULTS


Higher doses of CBL-514 (unit dose: 2.0 and 1.6 mg/cm 2) significantly improved the absolute and percentage reduction in abdominal fat volume (p<0.00001) and thickness (p<0.0001) compared to baseline. Although the COVID-19 pandemic halted some participant recruitment and follow-ups, analysis was unaffected, even after sample size limitations.
CONCLUSIONS


CBL-514 injection at multiple doses up to 300 mg with a unit dose of 2.0 mg/cm 2 is safe, well-tolerated and reduced abdominal fat volume and thickness by inducing adipocyte apoptosis. While other procedures exist to treat abdominal fat, they have limitations and may cause complications. At a dose of 2.0 mg/cm 2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, non-surgical abdominal fat reduction in dermatological clinics.",2022,"At a dose of 2.0 mg/cm 2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, non-surgical abdominal fat reduction in dermatological clinics.",[],"['CBL-514', 'CBL-514 injection', 'Novel Injection Lipolysis', 'CBL-514 Injection']","['Abdominal Subcutaneous Fat Reduction', 'abdominal subcutaneous fat volume and thickness', 'abdominal fat volume', 'abdominal subcutaneous fat', 'Adipocyte Apoptosis', 'safety and efficacy']",[],"[{'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C4552502', 'cui_str': 'Injection lipolysis'}]","[{'cui': 'C1563741', 'cui_str': 'Fat, Abdominal Subcutaneous'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.106659,"At a dose of 2.0 mg/cm 2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, non-surgical abdominal fat reduction in dermatological clinics.","[{'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Goodman', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Wilson W S', 'Initials': 'WWS', 'LastName': 'Ho', 'Affiliation': 'Private practice, Hong Kong.'}, {'ForeName': 'Kao-Jung', 'Initials': 'KJ', 'LastName': 'Chang', 'Affiliation': 'Private practice in Taipei City, Taiwan.'}, {'ForeName': 'Yu-Fang', 'Initials': 'YF', 'LastName': 'Ling', 'Affiliation': 'Caliway Biopharmaceuticals Co., Ltd. New Taipei City, Taiwan.'}, {'ForeName': 'An-Yi', 'Initials': 'AY', 'LastName': 'Sheu', 'Affiliation': 'Caliway Biopharmaceuticals Co., Ltd. New Taipei City, Taiwan.'}]",Aesthetic surgery journal,['10.1093/asj/sjac162']
2120,35704556,Male circumcision uptake during the Botswana Combination Prevention Project.,"INTRODUCTION


Voluntary medical male circumcision (VMMC) uptake has been slow in some countries, including Botswana. To inform demand creation efforts, we examined sociodemographic characteristics and referral procedures associated with VMMC uptake in the Botswana Combination Prevention Project (BCPP) and examined the effectiveness of referral of men to MC services from HIV testing venues.
DESIGN


BCPP was a community-randomized trial evaluating the impact of a combination HIV prevention package which included VMMC on community HIV incidence. We conducted a sub-analysis of VMMC uptake in intervention communities.
METHODS


During the initial VMMC campaign in 15 intervention communities, baseline male circumcision (MC) status was assessed among men eligible for HIV testing. Uncircumcised male community residents aged 16-49 years with negative/unknown HIV status were mobilized and linked to study VMMC services. Outcomes included MC baseline status and uptake through study services. Univariate and multivariate logistic regressions were performed to identify factors associated with MC uptake.
RESULTS


Of 12,864 men eligible for testing, 50% (n = 6,448) were already circumcised. Among the uncircumcised men (n = 6,416), 10% (n = 635) underwent MC. Of the 5,071 men identified as eligible for MC through HIV testing services, 78% declined referral and less than 1% of those were circumcised. Of those accepting referral (n = 1,107), 16% were circumcised. Younger (16-24 years) (aOR: 1.51; 95%CI:1.22,1.85), unemployed men (aOR:1.34; 95%CI: 1.06,1.69), and those undergoing HIV testing at mobile venues (aOR: 1.88; 95%CI: 1.53,2.31) were more likely to get circumcised. Fear of pain was the most prevalent (27%) reason given for not being circumcised.
CONCLUSION


Younger, unemployed men seeking HIV testing at mobile sites in Botswana were more likely to get VMMC. Addressing unique barriers for employed and older men may be necessary. Given the simplicity of VMMC as an intervention, the HIV testing programs offer a platform for identifying uncircumcised men and offering information and encouragement to access services.",2022,"Younger (16-24 years) (aOR: 1.51; 95%CI:1.22,1.85), unemployed men (aOR:1.34;","['5,071 men identified as eligible for MC through HIV testing services, 78% declined referral and less than 1% of those were circumcised', '15 intervention communities, baseline male circumcision (MC) status was assessed among men eligible for HIV testing', 'Voluntary medical male circumcision', '12,864 men eligible for testing, 50% (n = 6,448) were already circumcised', 'Younger (16-24 years) (aOR: 1.51; 95%CI:1.22,1.85), unemployed men (aOR:1.34', 'men to MC services from HIV testing venues', 'Uncircumcised male community residents aged 16-49 years with negative/unknown HIV status were mobilized and linked to study VMMC services']","['VMMC', 'MC']","['MC baseline status and uptake through study services', 'Male circumcision uptake', 'Fear of pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0282021', 'cui_str': 'Uncircumcised'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}]","[{'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0233702', 'cui_str': 'Algophobia'}]",6448.0,0.268714,"Younger (16-24 years) (aOR: 1.51; 95%CI:1.22,1.85), unemployed men (aOR:1.34;","[{'ForeName': 'Tafireyi', 'Initials': 'T', 'LastName': 'Marukutira', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Ussery', 'Affiliation': 'Division of Global HIV/AIDS, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Kadima', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mills', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Division of Global HIV/AIDS, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Block', 'Affiliation': 'Division of Global HIV/AIDS, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Division of Global HIV/AIDS, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Davis', 'Affiliation': 'Division of Global HIV/AIDS, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Schissler', 'Affiliation': 'Jhpiego, Gaborone, Botswana.'}, {'ForeName': 'Roselyn', 'Initials': 'R', 'LastName': 'Mosha', 'Affiliation': 'Jhpiego, Gaborone, Botswana.'}, {'ForeName': 'Onneile', 'Initials': 'O', 'LastName': 'Komotere', 'Affiliation': 'Jhpiego, Gaborone, Botswana.'}, {'ForeName': 'Thebeyame', 'Initials': 'T', 'LastName': 'Diswai', 'Affiliation': 'Jhpiego, Gaborone, Botswana.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Ntsuape', 'Affiliation': 'Department of HIV/AIDS Prevention and Care, Ministry of Health, Gaborone, Botswana.'}, {'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Department of HIV/AIDS Prevention and Care, Ministry of Health, Gaborone, Botswana.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Bock', 'Affiliation': 'Division of Global HIV/AIDS, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}]",PloS one,['10.1371/journal.pone.0269178']
2121,35704689,Virtual Reality and Powerpoint Grocery Store Tours: Equally Effective in Improving Self-efficacy in Randomised Control Trial.,"PURPOSE


Compare computer-based virtual reality (CBVR) and voice-over PowerPoint (PP) grocery store tours (GST) on adult nutrition literacy (NL) and healthful food purchasing self-efficacy (HFPSE).
DESIGN


Participants (n = 68) recruited from University worksite wellness program and randomly assigned to CBVR or PP (CBVR = 35; PP = 33).
INTERVENTION


Four-week culinary/nutrition education program. Initial three weeks provided identical education for both groups. Week four implemented GST intervention using CBVR or PP.
MEASURES


NL and HFPSE surveys before, after, and three-months post from the start of program.
ANALYSIS


Intent-to-treat (ITT) analysis with RMANOVA (95% confidence intervals [CI] and effect sizes) to examine change in NL and HFPSE between CBVR and PP groups over 4-week intervention and 3-month retention period.
RESULTS


43 of 68 participants [CBVR (n = 19) and PP (n = 24)] were included in analyses. Both groups significantly improved HFPSE over time (P<.001, CBVR = 46.23% PP = 33.34%), but there were no differences between groups ( P  = .21) or group by time interaction ( P  = .31). NL did not change for either group ( P  = .83, CBVR = 1.11%; PP = .12%) nor were there differences between groups ( P  = .07).
CONCLUSIONS


CBVR and PP GST significantly improved and maintained higher HFPSE scores.",2022,"Both groups significantly improved HFPSE over time (P<.001, CBVR = 46.23% PP = 33.34%), but there were no differences between groups ( P  = .21) or group by time interaction ( P  = .31).","['43 of 68 participants [CBVR (n = 19) and PP (n = 24', 'Participants (n = 68) recruited from University worksite wellness program and randomly assigned to CBVR or PP (CBVR = 35; PP = 33']","['Four-week culinary/nutrition education program', 'computer-based virtual reality (CBVR) and voice-over PowerPoint (PP) grocery store tours (GST', 'CBVR and PP', 'Virtual Reality and Powerpoint Grocery Store Tours', 'GST']","['HFPSE scores', 'Self-efficacy', 'HFPSE over time']","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",68.0,0.0292432,"Both groups significantly improved HFPSE over time (P<.001, CBVR = 46.23% PP = 33.34%), but there were no differences between groups ( P  = .21) or group by time interaction ( P  = .31).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pilut', 'Affiliation': 'Department of Food Science and Human Nutrition, 228928Iowa State University, Ames, IA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hollis', 'Affiliation': 'Department of Food Science and Human Nutrition, 228928Iowa State University, Ames, IA, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Lanningham-Foster', 'Affiliation': 'Department of Food Science and Human Nutrition, 228928Iowa State University, Ames, IA, USA.'}, {'ForeName': 'E Andrew', 'Initials': 'EA', 'LastName': 'Pitchford', 'Affiliation': 'Department of Kinesiology, 1177Iowa State University, Ames, IA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Litchfield', 'Affiliation': 'Department of Food Science and Human Nutrition, 228928Iowa State University, Ames, IA, USA.'}]",American journal of health promotion : AJHP,['10.1177/08901171221108274']
2122,35705150,Fluid REStriction in Heart failure versus liberal fluid UPtake: Rationale and design of the randomised FRESH-UP study.,"AIMS


It is common practice for clinicians to advise fluid restriction to heart failure (HF) patients, but data from clinical trials are lacking. Moreover, fluid restriction is associated with thirst distress and may adversely impact quality of life (QoL). To address this gap in evidence, the Fluid REStriction in Heart failure versus liberal fluid UPtake (FRESH-UP) study was initiated.
METHODS


The FRESH-UP study is a randomised, controlled, open-label, multicentre trial to investigate the effect of a 3-month period of liberal fluid intake versus fluid restriction (1500ml/day) on QoL in outpatient chronic HF patients (NYHA II-III). The primary aim is to assess the effect on QoL after 3 months using the Overall Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). Thirst distress as assessed by the Thirst Distress Scale for patients with HF, KCCQ Clinical Summary Score, each of the KCCQ domains and clinically meaningful changes in these scores, the EQ-5D-5L, patient reported fluid intake and safety (i.e. death, HF hospitalisations) are secondary outcomes. The FRESH-UP study is registered at ClinicalTrials.gov (NCT04551729).
CONCLUSION


The results of the FRESH-UP study will substantially add to the level of evidence concerning fluid management in chronic HF and may impact QoL of these patients.",2022,"Thirst distress as assessed by the Thirst Distress Scale for patients with HF, KCCQ Clinical Summary Score, each of the KCCQ domains and clinically meaningful changes in these scores, the EQ-5D-5L, patient reported fluid intake and safety (i.e. death, HF hospitalisations) are secondary outcomes.",['outpatient chronic HF patients (NYHA II-III'],"['Fluid REStriction', 'liberal fluid intake versus fluid restriction (1500ml/day']","['impact quality of life (QoL', 'Thirst Distress Scale', 'Overall Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0204700', 'cui_str': 'Fluid restriction'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}]",,0.502134,"Thirst distress as assessed by the Thirst Distress Scale for patients with HF, KCCQ Clinical Summary Score, each of the KCCQ domains and clinically meaningful changes in these scores, the EQ-5D-5L, patient reported fluid intake and safety (i.e. death, HF hospitalisations) are secondary outcomes.","[{'ForeName': 'Job J', 'Initials': 'JJ', 'LastName': 'Herrmann', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands. Electronic address: Job.Herrmann@radboudumc.nl.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Beckers-Wesche', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lisette E H J M', 'Initials': 'LEHJM', 'LastName': 'Baltussen', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Marjolein H I', 'Initials': 'MHI', 'LastName': 'Verdijk', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bellersen', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Brunner-La Rocca', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Tiny', 'Initials': 'T', 'LastName': 'Jaarsma', 'Affiliation': 'Faculty of Medical and Health Sciences, Department of Social and Welfare Studies, Linköping University, Sweden.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Pisters', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sanders-Van Wijk', 'Affiliation': 'Department of Cardiology, Zuyderland Medical Center, Heerlen/Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rodwell', 'Affiliation': 'Section Biostatistics, Department for Health Evidence, Radboud Institute of Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Niels van', 'Initials': 'NV', 'LastName': 'Royen', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'D H Frank', 'Initials': 'DHF', 'LastName': 'Gommans', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2022.05.015']
2123,35705139,Simvastatin reduces plasma membrane caveolae and caveolin-1 in uterine leiomyomas.,"AIMS


Uterine leiomyomas, or fibroids, are estrogen dependent benign tumor in women, however, they have limited treatment options. Simvastatin, a drug commonly used to treat high cholesterol. Recently we demonstrated that simvastatin alters estrogen signaling by reducing the expression and trafficking of the estrogen receptor-α (ER-α) in human uterine leiomyoma cells. Caveolae are invaginations of the plasma membrane where ER-α is known to localize and directly interacts with the caveolar protein caveolin-1 (CAV1). This study examines the effects of simvastatin on plasma membrane caveolae and the expression and palmitoylation of CAV1 in human leiomyomas which may influence ER-α signaling.
MAIN METHODS


We performed in vitro experiments using primary and immortalized human uterine leiomyoma cells. The caveolae were quantified using transmission electron microscopy. Additionally, we examined the impact of simvastatin treatment (40 mg orally per day for 12 weeks) on human leiomyoma tissue obtained from a randomized controlled trial. The CAV1 protein and mRNA levels were determined using quantitative real-time polymerase chain reactions, western blotting, and immunofluorescence analyses.
KEY FINDINGS


Simvastatin decreased the number of caveolae in primary leiomyoma cells and reduced CAV1 abundance in whole cells and remarkably the plasma protein fraction. It also decreased CAV1 palmitoylation, a post-translational modification associated with CAV1 activation. The effects of simvastatin on CAV1 were recapitulated in human leiomyoma tissue samples.
SIGNIFICANCE


Our results identify caveolae and CAV1 as novel targets of simvastatin which may contribute to the recently described effects of simvastatin on ER-α signaling and plasma membrane trafficking.",2022,"KEY FINDINGS


Simvastatin decreased the number of caveolae in primary leiomyoma cells and reduced CAV1 abundance in whole cells and remarkably the plasma protein fraction.","['human leiomyoma tissue samples', 'human uterine leiomyoma cells', 'We performed in vitro experiments using primary and immortalized human uterine leiomyoma cells']","['simvastatin', 'Simvastatin']","['CAV1 palmitoylation', 'number of caveolae in primary leiomyoma cells and reduced CAV1 abundance', 'CAV1 protein and mRNA levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C1292533', 'cui_str': 'Tissue specimen'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0379710', 'cui_str': 'Caveolin-1'}, {'cui': 'C0598435', 'cui_str': 'Palmitoylation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0230653', 'cui_str': 'Micropinocytotic vesicle'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0951916,"KEY FINDINGS


Simvastatin decreased the number of caveolae in primary leiomyoma cells and reduced CAV1 abundance in whole cells and remarkably the plasma protein fraction.","[{'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Afrin', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Malak', 'Initials': 'M', 'LastName': 'El Sabeh', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Miyashita-Ishiwata', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Charewycz', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Bhuchitra', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Mostafa A', 'Initials': 'MA', 'LastName': 'Borahay', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA. Electronic address: mboraha1@jhmi.edu.'}]",Life sciences,['10.1016/j.lfs.2022.120708']
2124,35705018,Differential Gene Expression in Cord Blood of Infants Diagnosed with Cerebral Palsy: a Pilot Analysis of the BEAM Cohort.,"The Beneficial Effects of Antenatal Magnesium (BEAM) clinical trial was conducted between 1997-2007, and demonstrated a significant reduction in cerebral palsy (CP) in preterm infants who were exposed to peripartum magnesium sulfate (MgSO4). However, the mechanism by which MgSO4 confers neuroprotection remains incompletely understood. Cord blood samples from this study were interrogated during an era when next generation sequencing was not widely accessible and few gene expression differences or biomarkers were identified between treatment groups. Our goal was to use bulk RNA deep sequencing to identify differentially expressed genes comparing the following four groups: newborns who ultimately developed CP treated with MgSO4 or placebo, and controls (newborns who ultimately did not develop CP) treated with MgSO4 or placebo. Those who died after birth were excluded. We found that MgSO4 upregulated expression of SCN5A only in the control group, with no change in gene expression in cord blood of newborns who ultimately developed CP. Regardless of MgSO4 exposure, expression of NPBWR1 and FTO were upregulated in cord blood of newborns who ultimately developed CP compared with controls. These data support that MgSO4 may not exert its neuroprotective effect through changes in gene expression. Moreover, NPBWR1 and FTO may be useful as biomarkers, and may suggest new mechanistic pathways to pursue in understanding the pathogenesis of CP. The small number of cases ultimately available for this secondary analysis, with male predominance and mild CP phenotype, is a limitation of the study. In addition, differentially expressed genes were not validated by qRT-PCR.",2022,"We found that MgSO4 upregulated expression of SCN5A only in the control group, with no change in gene expression in cord blood of newborns who ultimately developed CP.","['Infants Diagnosed with Cerebral Palsy', ' and controls (newborns who ultimately did not develop CP) treated with', 'preterm infants who were exposed to']","['Antenatal Magnesium (BEAM', 'peripartum magnesium sulfate (MgSO4', 'MgSO4 or placebo']","['MgSO4 exposure, expression of NPBWR1 and FTO', 'MgSO4 upregulated expression of SCN5A', 'cerebral palsy (CP']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2936491', 'cui_str': 'Peripartum period'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]",,0.105088,"We found that MgSO4 upregulated expression of SCN5A only in the control group, with no change in gene expression in cord blood of newborns who ultimately developed CP.","[{'ForeName': 'Maria L V', 'Initials': 'MLV', 'LastName': 'Dizon', 'Affiliation': ''}, {'ForeName': 'Raye-Ann O', 'Initials': 'RO', 'LastName': 'deRegnier', 'Affiliation': ''}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Costantine', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': ''}, {'ForeName': 'Nina K', 'Initials': 'NK', 'LastName': 'Ayala', 'Affiliation': ''}, {'ForeName': 'Antonio F', 'Initials': 'AF', 'LastName': 'Saad', 'Affiliation': ''}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Caritis', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Developmental neuroscience,['10.1159/000525483']
2125,35704960,"Efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome: A double-blind, randomized, placebo-controlled trial.","BACKGROUND


Irritable bowel syndrome (IBS) affects 9,2% of the global population and places a considerable burden on healthcare systems. Most medications for treating IBS, including spasmolytics, laxatives, and antidiarrheals, have low efficacy. Effective and safe therapeutic treatments have yet to be developed for IBS.
PURPOSE


This study assessed the efficacy and safety of a food supplement containing standardized menthol, limonene, and gingerol in human participants with IBS or IBS/functional dyspepsia (FD).
DESIGN


A double-blind, randomized, placebo-controlled trial.
METHODS


We randomly assigned 56 patients with IBS or IBS/FD to an intervention group (Group 1) or control group (Group 2) that were given supplement or placebo, respectively, in addition to the standard treatment regimen for 30 d. Three outpatient visits were conducted during the study. Symptom severity was measured at each visit using a 7×7 questionnaire. Qualitative and quantitative composition of the intestinal microbiota were assessed at visits 1 and 3 based on 16S rRNA gene sequencing.
RESULTS


At visit 1 (before treatment), the median total 7×7 questionnaire score was in the moderately ill range for both groups, with no difference between the groups (p = 0.1). At visit 2, the total 7×7 score decreased to mildly ill, with no difference between the groups (p = 0.4). At visit 3, the total score for group 1 indicated borderline illness and for group 2 remained indicated mild illness (p = 0.009). Even though we observed some variations in gut microbiota between the groups, we did not find any statistically significant changes.
CONCLUSION


The food supplement with standardized menthol, limonene, and gingerol content increased the efficacy of standard therapy in IBS and FD patients. The use of the supplement did not cause any obvious side effects.
REGISTRATION


ClinicalTrials.gov Identifier: NCT04484467.",2022,"At visit 2, the total 7×7 score decreased to mildly ill, with no difference between the groups (p = 0.4).","['IBS and FD patients', '56 patients with IBS or', 'patients with irritable bowel syndrome', 'human participants with IBS or IBS/functional dyspepsia (FD']","['food supplement containing standardized menthol, limonene, and gingerol', 'IBS/FD to an intervention group (Group 1) or control group (Group 2) that were given supplement or placebo', 'food supplement with standardized menthol, limonene, and gingerol content', 'placebo']","['total 7×7 score decreased to mildly ill', 'borderline illness', 'median total 7×7 questionnaire score', 'Symptom severity', 'efficacy and safety', 'Efficacy and safety', 'Qualitative and quantitative composition of the intestinal microbiota', 'mild illness', 'gut microbiota']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0064992', 'cui_str': 'limonene'}, {'cui': 'C0061267', 'cui_str': 'gingerol'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",56.0,0.314955,"At visit 2, the total 7×7 score decreased to mildly ill, with no difference between the groups (p = 0.4).","[{'ForeName': 'Vladimir T', 'Initials': 'VT', 'LastName': 'Ivashkin', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Anna V', 'Initials': 'AV', 'LastName': 'Kudryavtseva', 'Affiliation': 'Engelhardt Institute of Molecular Biology, Russian Academy of Sciences, Moscow, Russian Federation.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Krasnov', 'Affiliation': 'Engelhardt Institute of Molecular Biology, Russian Academy of Sciences, Moscow, Russian Federation.'}, {'ForeName': 'Yuri M', 'Initials': 'YM', 'LastName': 'Poluektov', 'Affiliation': 'Engelhardt Institute of Molecular Biology, Russian Academy of Sciences, Moscow, Russian Federation.'}, {'ForeName': 'Margarita A', 'Initials': 'MA', 'LastName': 'Morozova', 'Affiliation': 'Mental Health Research Center, Moscow, Russian Federation.'}, {'ForeName': 'Oleg S', 'Initials': 'OS', 'LastName': 'Shifrin', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Allan G', 'Initials': 'AG', 'LastName': 'Beniashvili', 'Affiliation': 'Engelhardt Institute of Molecular Biology, Russian Academy of Sciences, Moscow, Russian Federation.'}, {'ForeName': 'Zarina A', 'Initials': 'ZA', 'LastName': 'Mamieva', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Kovaleva', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Anatoly I', 'Initials': 'AI', 'LastName': 'Ulyanin', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Elizaveta A', 'Initials': 'EA', 'LastName': 'Trush', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Erlykin', 'Affiliation': 'Moscow State Linguistic University, Moscow, Russian Federation.'}, {'ForeName': 'Elena A', 'Initials': 'EA', 'LastName': 'Poluektova', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}]",PloS one,['10.1371/journal.pone.0263880']
2126,35704951,"A double-blind, randomized, placebo-controlled proof of concept study of the efficacy and safety of Lu AF11167 for persistent negative symptoms in people with schizophrenia.","Lu AF11167 is a selective, high-affinity inhibitor of PDE10A that modulates dopamine D1 and D2 receptor-mediated intraneuronal signalling without binding to these receptors. This randomized, double-blind, parallel-group, placebo-controlled study (NCT03793712) with open-label extension (NCT03929497) evaluated the efficacy of two fixed-flexible doses (1-2mg/day and 3-4mg/day) of Lu AF11167 in stable, non-acute patients with schizophrenia and persistent prominent negative symptoms. The studies were discontinued following a futility analysis of the double-blind study, and we report data collected up to study termination. Of the 210 patients screened, 162 were randomized, 111 completed the double-blind study and 96 entered the open-label study before early termination. The withdrawal rate due to impending relapse was low and comparable across treatment groups (n = 2-4 per group in the double-blind study and n = 1 in the open-label extension). Double-blind treatment with Lu AF11167 3-4mg was not superior to placebo in the reduction of Brief Negative Symptom Scale (BNSS) total scores from Baseline to Week 12 (primary endpoint); adjusted mean changes were -6.8 with placebo, -5.7 with Lu AF11167 1-2 mg group and -6.0 with Lu AF11167 3-4mg. Treatment with Lu AF11167 1-2mg also failed to separate from placebo on the primary endpoint. Neither dose group showed significant improvements versus placebo on any of the secondary efficacy measures exploring effect of treatment on overall symptomology, negative symptoms, positive symptoms, or functioning. Administration of Lu AF11167 was safe and well tolerated and adverse events were not a major reason for withdrawal from the study.",2022,"Neither dose group showed significant improvements versus placebo on any of the secondary efficacy measures exploring effect of treatment on overall symptomology, negative symptoms, positive symptoms, or functioning.","['acute patients with schizophrenia and persistent prominent negative symptoms', '210 patients screened, 162 were randomized, 111 completed the double-blind study and 96 entered the open-label study before early termination', 'people with schizophrenia']","['Lu AF11167 3-4mg was not superior to placebo', 'Lu AF11167', 'placebo', 'Lu AF11167 1-2mg also failed to separate from placebo']","['overall symptomology, negative symptoms, positive symptoms, or functioning', 'withdrawal rate', 'Brief Negative Symptom Scale (BNSS', 'total scores', 'safe and well tolerated and adverse events']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",162.0,0.568393,"Neither dose group showed significant improvements versus placebo on any of the secondary efficacy measures exploring effect of treatment on overall symptomology, negative symptoms, positive symptoms, or functioning.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meyer-Lindenberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim / Heidelberg University, J5, Mannheim 68159, Germany. Electronic address: Andreas.Meyer-Lindenberg@zi-mannheim.de.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Nielsen', 'Affiliation': 'H. Lundbeck A/S, Valby 2500, Denmark.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Such', 'Affiliation': 'H. Lundbeck A/S, Valby 2500, Denmark.'}, {'ForeName': 'Ole Michael', 'Initials': 'OM', 'LastName': 'Lemming', 'Affiliation': 'H. Lundbeck A/S, Valby 2500, Denmark.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zambori', 'Affiliation': 'H. Lundbeck A/S, Valby 2500, Denmark.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Buller', 'Affiliation': 'H. Lundbeck A/S, Valby 2500, Denmark.'}, {'ForeName': 'Christoph von', 'Initials': 'CV', 'LastName': 'der Goltz', 'Affiliation': 'H. Lundbeck A/S, Valby 2500, Denmark.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2022.05.009']
2127,35705346,"Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R 2 ): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research.","INTRODUCTION


Rural communities bear a disproportionate share of the opioid and methamphetamine use disorder epidemics. Yet, rural people who use drugs (PWUD) are rarely included in trials testing new drug use prevention and treatment strategies. Numerous barriers impede rural PWUD trial engagement and advancing research methods to better retain rural PWUD in clinical trials is needed. This paper describes the Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R 2 ) study protocol to test the effectiveness of a peer-driven intervention to improve study retention among rural PWUD.
METHODS AND ANALYSIS


The PROUD-R 2  study is being implemented in 21 rural counties in three states (Kentucky, Ohio and Oregon). People who are 18 years or older, reside in the study area and either used opioids or injected any drug to get high in the past 30 days are eligible for study inclusion. Participants are allocated in a 1:1 ratio to two arms, stratified by site to assure balance at each geographical location. The trial compares the effectiveness of two retention strategies. Participants randomised to the control arm provide detailed contact information and receive standard retention outreach by study staff (ie, contacts for locator information updates, appointment reminders). Participants randomised to the intervention arm are asked to recruit a 'study buddy' in addition to receiving standard retention outreach. Study buddies are invited to participate in a video training and instructed to remind their intervention participant of follow-up appointments and encourage retention. Assessments are completed by intervention, control and study buddy participants at 6 and 12 months after enrolment.
ETHICS AND DISSEMINATION


The protocol was approved by a central Institutional Review Board (University of Utah). Results of the study will be disseminated in academic conferences and peer-reviewed journals, online and print media, and in meetings with community stakeholders.
TRIAL REGISTRATION NUMBER


NCT03885024.",2022,"This paper describes the Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R 2 ) study protocol to test the effectiveness of a peer-driven intervention to improve study retention among rural PWUD.
","['People who are 18 years or older, reside in the study area and either used opioids or injected any drug to get high in the past 30 days are eligible for study inclusion', '21 rural counties in three states (Kentucky, Ohio and Oregon', 'rural people who use drugs in research', 'rural people who use drugs (PWUD']","['Peer-based Retention Of people who Use Drugs', 'standard versus peer-based approaches', ""intervention arm are asked to recruit a 'study buddy' in addition to receiving standard retention outreach"", 'peer-driven intervention', 'control arm provide detailed contact information and receive standard retention outreach by study staff (ie, contacts for locator information updates, appointment reminders']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]",[],,0.0358581,"This paper describes the Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R 2 ) study protocol to test the effectiveness of a peer-driven intervention to improve study retention among rural PWUD.
","[{'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Young', 'Affiliation': 'Epidemiology, University of Kentucky, Lexington, Kentucky, USA april.young@uky.edu.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'Division of Epidemiology, Ohio State University College of Public Health, Columbus, Ohio, USA.'}, {'ForeName': 'Sarann', 'Initials': 'S', 'LastName': 'Bielavitz', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Miriam R', 'Initials': 'MR', 'LastName': 'Elman', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Ryan R', 'Initials': 'RR', 'LastName': 'Cook', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Leichtling', 'Affiliation': 'Comagine Health, Portland, Oregon, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Freeman', 'Affiliation': 'Department of Epidemiology, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Angela T', 'Initials': 'AT', 'LastName': 'Estadt', 'Affiliation': 'The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Alexander', 'Affiliation': 'Department of Epidemiology, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Caiti', 'Initials': 'C', 'LastName': 'Barrie', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Kandi', 'Initials': 'K', 'LastName': 'Conn', 'Affiliation': 'Department of Epidemiology, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Rhody', 'Initials': 'R', 'LastName': 'Elzaghal', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Maybrier', 'Affiliation': 'Department of Epidemiology, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'McDowell', 'Affiliation': 'The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Neal', 'Affiliation': 'The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Lapidus', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Elizabeth N', 'Initials': 'EN', 'LastName': 'Waddell', 'Affiliation': 'OHSU-PSU School of Public Health, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}]",BMJ open,['10.1136/bmjopen-2022-064400']
2128,35705334,Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial).,"INTRODUCTION


Atrial fibrillation (AF), with a prevalence of 2%, is the most common cardiac arrhythmia. Catheter ablation (CA) has been documented to be superior to treatment by antiarrhythmic drugs (AADs) in terms of sinus rhythm maintenance. However, in obese patients, substantial weight loss was also associated with AF reduction. So far, no study has compared the modern non-invasive (AADs combined with risk factor modification (RFM)) approach with modern invasive (CA) treatment. The aim of the trial is to compare the efficacy of modern invasive (CA) and non-invasive (AADs with risk factor management) treatment of AF.
METHODS AND ANALYSIS


The trial will be a prospective, multicentre, randomised non-inferiority trial. Patients with symptomatic AF and a body mass index >30 will be enrolled and randomised to the CA or RFM arm (RFM+AAD) in a 1:1 ratio. In the CA arm, pulmonary vein isolation (in combination with additional lesion sets in non-paroxysmal patients) will be performed. For patients in the RFM+AAD arm, the aim will be a 10% weight loss over 6-12 months, increased physical fitness and a reduction in alcohol consumption. The primary endpoint will be an episode of AF or regular atrial tachycardia lasting >30 s. The secondary endpoints include AF burden, clinical endpoints associated with AF reoccurrence, changes in the quality of life assessed using dedicated questionnaires, changes in cardiorespiratory fitness and metabolic endpoints. An AF freedom of 65% in the RFM+AAD and of 60% in the CA is expected; therefore, 202 patients will be enrolled to achieve the non-inferiority with 80% power, 5% one-sided alpha and a non-inferiority margin of 12%.
ETHICS AND DISSEMINATION


The PRAGUE-25 trial will determine if modern non-invasive AF treatment strategies are non-inferior to CA. The study was approved by the Ethics Committee of the University Hospital Kralovske Vinohrady. Results of the study will be disseminated on scientific conferences and in peer-reviewed scientific journals. After the end of follow-up, data will be available upon request to principal investigator.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04011800).",2022,>30 will be enrolled and randomised to the CA or RFM arm (RFM+AAD) in a 1:1 ratio.,"['Patients with symptomatic AF and a body mass index', 'atrial fibrillation', '202 patients']","['modern non-invasive (AADs combined with risk factor modification (RFM)) approach with modern invasive (CA', 'Catheter ablation versus antiarrhythmic drugs with risk factor modification', 'modern invasive (CA) and non-invasive (AADs with risk factor management', 'Catheter ablation (CA']","['substantial weight loss', 'alcohol consumption', 'physical fitness', 'AF burden, clinical endpoints associated with AF reoccurrence, changes in the quality of life assessed using dedicated questionnaires, changes in cardiorespiratory fitness and metabolic endpoints', 'episode of AF or regular atrial tachycardia lasting ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}]",202.0,0.15971,>30 will be enrolled and randomised to the CA or RFM arm (RFM+AAD) in a 1:1 ratio.,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Osmancik', 'Affiliation': 'Department of Cardiology, Kralovske Vinohrady University Hospital, Prague, Czech Republic pavel.osmancik@gmail.com.'}, {'ForeName': 'Štěpán', 'Initials': 'Š', 'LastName': 'Havránek', 'Affiliation': 'Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Prague, Czech Republic.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Bulková', 'Affiliation': 'Department of Cardiology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Chovančík', 'Affiliation': 'Department of Cardiology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Tomáš', 'Initials': 'T', 'LastName': 'Roubíček', 'Affiliation': 'Department of Cardiology, Regional Hospital Liberec, Liberec, Czech Republic.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Heřman', 'Affiliation': 'Department of Cardiology, Kralovske Vinohrady University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Čarná', 'Affiliation': 'Department of Cardiology, Kralovske Vinohrady University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Tuka', 'Affiliation': 'Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Matoulek', 'Affiliation': 'Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fiala', 'Affiliation': 'Department of Cardiology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Otakar', 'Initials': 'O', 'LastName': 'Jiravský', 'Affiliation': 'Department of Cardiology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Stregl-Hruskova', 'Affiliation': 'Department of Cardiology, Regional Hospital Liberec, Liberec, Czech Republic.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Latiňák', 'Affiliation': 'Department of Cardiology, Regional Hospital Liberec, Liberec, Czech Republic.'}, {'ForeName': 'Jiřina', 'Initials': 'J', 'LastName': 'Kotryová', 'Affiliation': 'Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Jarkovský', 'Affiliation': 'Institute of Biostatistics and Analyses, Brno University of Technology, Brno, Czech Republic.'}]",BMJ open,['10.1136/bmjopen-2021-056522']
2129,35705264,Comparison of postoperative analgesic effects of posterior quadratus lumborum block and intrathecal morphine in laparoscopic donor hepatectomy: a prospective randomized non-inferiority clinical trial.,"BACKGROUND


Posterior quadratus lumborum block (QLB) and intrathecal morphine are accepted analgesic strategies in laparoscopic liver resection, but their effects have not been compared after laparoscopic donor hepatectomy. This study was planned to perform this comparison.
METHODS


Fifty-six donors were randomized to receive bilateral posterior (QLB2, 20 mL of 0.375% ropivacaine on each side, 150 mg total) or preoperative injection of 0.4 mg morphine sulfate intrathecally. Primary outcome was resting pain score at 24 hour postsurgery. Secondary outcomes included cumulative opioid consumption and recovery parameters. Serial plasma ropivacaine concentrations were measured in QLB group. Only the outcome assessor was properly blinded.
RESULTS


Mean resting pain score at 24-hour postsurgery was 4.19±1.66 in QLB group (n=27) and 3.07±1.41 in intrathecal morphine group (n=27, p=0.04). Mean difference (QLB group-intrathecal morphine group) was 1.11 (95% CI 0.27 to 1.95), and the upper limit of CI was higher than prespecified non-inferiority margin (δ=1), indicating an inferior effect of QLB. Cumulative opioid consumption was significantly higher in QLB group at 24 hours and 48 hours postsurgery. QLB group exhibited lower incidence of postoperative pruritus at all time points, and there were no differences in other recovery outcomes. All measured ropivacaine concentrations were below the threshold for systemic toxicity (4.3 µg/mL).
CONCLUSIONS


Bilateral posterior QLB elicited higher resting pain scores at 24-hour after laparoscopic donor hepatectomy than intrathecal morphine and did not meet the definition of non-inferiority.
TRIAL REGISTRATION NUMBER


KCT0005360.",2022,"QLB group exhibited lower incidence of postoperative pruritus at all time points, and there were no differences in other recovery outcomes.","['laparoscopic donor hepatectomy', 'Fifty-six donors']","['Posterior quadratus lumborum block (QLB) and intrathecal morphine', 'bilateral posterior (QLB2, 20 mL of 0.375% ropivacaine on each side, 150 mg total) or preoperative injection of 0.4 mg morphine sulfate intrathecally', 'QLB', 'posterior quadratus lumborum block and intrathecal morphine', 'intrathecal morphine']","['resting pain score', 'Cumulative opioid consumption', 'ropivacaine concentrations', 'upper limit of CI', 'Serial plasma ropivacaine concentrations', 'postoperative pruritus', 'cumulative opioid consumption and recovery parameters', 'systemic toxicity', 'resting pain scores', 'Mean resting pain score']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0411259', 'cui_str': 'Removal of liver from donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4552199', 'cui_str': 'Systemic toxicity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",56.0,0.456555,"QLB group exhibited lower incidence of postoperative pruritus at all time points, and there were no differences in other recovery outcomes.","[{'ForeName': 'Seungwon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gang-nam gu, Seoul, Korea.'}, {'ForeName': 'Ryung A', 'Initials': 'RA', 'LastName': 'Kang', 'Affiliation': 'Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gang-nam gu, Seoul, Korea.'}, {'ForeName': 'Gaab Soo', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gang-nam gu, Seoul, Korea.'}, {'ForeName': 'Mi Sook', 'Initials': 'MS', 'LastName': 'Gwak', 'Affiliation': 'Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gang-nam gu, Seoul, Korea.'}, {'ForeName': 'Gyu-Seong', 'Initials': 'GS', 'LastName': 'Choi', 'Affiliation': 'Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gang-nam gu, Seoul, Korea.'}, {'ForeName': 'Jong Man', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gang-nam gu, Seoul, Korea.'}, {'ForeName': 'Justin Sangwook', 'Initials': 'JS', 'LastName': 'Ko', 'Affiliation': 'Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gang-nam gu, Seoul, Korea justinswko@gmail.com.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2022-103577']
2130,35705263,Effect of suprainguinal fascia iliaca compartment block on postoperative opioid consumption and functional recovery in posterolateral-approached total hip arthroplasty: a single-blind randomized controlled trial.,"INTRODUCTION


Posterolateral-approached total hip arthroplasty (PLTHA) is followed by moderate to severe postoperative pain. Suprainguinal fascia iliaca compartment block (SFICB) has been proposed as a promising analgesia technique.
METHODS


Data from 86 patients scheduled for PLTHA with spinal anesthesia were analyzed in this prospective randomized controlled trial. Patients were randomly divided into two groups of 43 patients each. As opposed to the control group (group C), ropivacaine group (group R) received additional SFICB using 40 mL of 0.375% ropivacaine. As primary endpoint, blind observers noted total morphine consumption at postoperative 48 hours. Secondary endpoints were pain at rest and mobilization on 0-10 Numeric Rating Scale (rest and dynamic NRS) at fixed time points (1 hour and 6 hours after surgery, and at day 1 and day 2 at 8:00, 13:00 and 18:00 hours), walking performance at day 1 and day 2; postoperative complications including morphine-related side effects or orthostatic intolerance symptoms such as dizziness, nausea, blurred vision or vasovagal syncope.
RESULTS


A 48-hour morphine consumption (mg; median (IQR)) was significantly lower in group R than in group C (11 (8.5-15.5)) vs 26 (21-33.5), p<0001), as well as incidence of morphine-related side effects such as nausea at day 1 (p=0.04) and day 2 (p<0.01). Rest and dynamic NRS were globally significantly lower in group R than in group C (p<0.01). Group R showed less orthostatic intolerance at day 1 (p<0.001) and day 2 (p<0.01) and better functional walking performance at day 1 (<0.001) and day 2 (<0.001).
DISCUSSION


In PLTHA, SFICB provides opioid sparing, improved postoperative pain control, and enhanced functional recovery.
TRIAL REGISTRATION NUMBER


NCT04574479.",2022,Rest and dynamic NRS were globally significantly lower in group R than in group C (p<0.01).,"['86 patients scheduled for PLTHA with spinal anesthesia', 'posterolateral-approached total hip arthroplasty']","['additional SFICB using 40\u2009mL of 0.375% ropivacaine', 'suprainguinal fascia iliaca compartment block', 'Posterolateral-approached total hip arthroplasty (PLTHA', 'Suprainguinal fascia iliaca compartment block (SFICB', 'ropivacaine']","['pain at rest and mobilization on 0-10 Numeric Rating Scale (rest and dynamic NRS', 'postoperative pain control', 'Rest and dynamic NRS', 'functional walking performance', 'incidence of morphine-related side effects such as nausea', 'postoperative opioid consumption and functional recovery', 'walking performance', 'orthostatic intolerance', 'total morphine consumption', 'postoperative complications including morphine-related side effects or orthostatic intolerance symptoms such as dizziness, nausea, blurred vision or vasovagal syncope']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0042420', 'cui_str': 'Vasovagal syncope'}]",86.0,0.204831,Rest and dynamic NRS were globally significantly lower in group R than in group C (p<0.01).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Carella', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Central University Hospital of Liege, Liege, Belgium mcarella@chuliege.be.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Beck', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Central University Hospital of Liege, Liege, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Piette', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Central University Hospital of Liege, Liege, Belgium.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Denys', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Sports Traumatology, Central University Hospital of Liege, Liege, Belgium.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kurth', 'Affiliation': 'Department of Locomotor System Surgery, Central University Hospital of Liege, Liege, Belgium.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Lecoq', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Central University Hospital of Liege, Liege, Belgium.'}, {'ForeName': 'Vincent L', 'Initials': 'VL', 'LastName': 'Bonhomme', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Central University Hospital of Liege, Liege, Belgium.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2021-103427']
2131,35705256,Peer Group Support Intervention to Reduce Cardiovascular Disease Risk for African American Men According to Life's Simple 7 in Faith-Based Communities.,"BACKGROUND AND PURPOSE


Adverse cardiovascular health disparities persist for African American men. Although changing health behaviors is perhaps one of the most effective methods to prevent cardiovascular disease (CVD)-related deaths, previous behavior change programs targeting single or multiple CVD risk factors in target groups have had mixed success. The purpose of this pilot study was to determine whether a multi-faceted peer group intervention model based on American Heart Association's Life's Simple 7 was feasible, safe, acceptable, and efficacious in producing meaningful risk reduction for African American men.
METHODS


A convenience sample of 24 African American men with at least one CVD risk factor participated quasi-experimental study having peer intervention vs .  nonequivalent comparison groups, with pretest-posttests at two church sites in Minneapolis, MN (MPLS) and Washington, D.C. (DC). Feasibility, safety, acceptability, and potential efficacy were assessed by examining completion of peer group sessions, adverse events, attendance, attrition, within and between-group changes in measures using nonparametric statistics.
RESULTS


All twenty-four men completed the study with no study-related adverse symptoms and medical events. The peer groups had moderate to high attendance, and the peer program evaluation was highly positive among participants. Between baseline and 6-months, there were significant differences between the intervention and the comparison group in cholesterol levels and weights ( p  = .041,  p  = .034, respectively) at one site (DC). There were no significant between-group changes at the other site (MPLS).
IMPLICATION FOR PRACTICE


The multi-faceted peer support intervention was feasible, acceptable, and shown to have potential efficacy to reduce CVD risk for highly motivated African American men. Future studies with a larger sample size are needed to test the effectiveness of this intervention model to reduce CVD risk among African American men.",2022,"The multi-faceted peer support intervention was feasible, acceptable, and shown to have potential efficacy to reduce CVD risk for highly motivated African American men.","['African American Men', 'All twenty-four men completed the study with no study-related adverse symptoms and medical events', '24 African American men with at least one CVD risk factor participated quasi-experimental study having peer intervention vs ', 'African American men']",['Peer Group Support Intervention'],"['adverse events, attendance, attrition', 'CVD risk', 'cholesterol levels and weights', 'Feasibility, safety, acceptability, and potential efficacy']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",24.0,0.0236694,"The multi-faceted peer support intervention was feasible, acceptable, and shown to have potential efficacy to reduce CVD risk for highly motivated African American men.","[{'ForeName': 'Sohye', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Assistant Professor, University of Memphis, Loewenberg College of Nursing, 4055 North Park Loop, Memphis, TN 38152, USA slee26@memphis.edu.'}, {'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Niakosari Hadidi', 'Affiliation': 'Associate Professor, University of Minnesota, School of Nursing, 5-140 Weaver-Densford Hall, 308 Harvard Street SE, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Senior Biostatistician, University of Minnesota, Masonic Cancer Center, 425 E River Pkwy, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Kelley', 'Affiliation': 'Mount Airy Baptist Church, Washington, DC, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lindquist', 'Affiliation': 'Professor Emeritus, University of Minnesota, School of Nursing, 5-140 Weaver-Densford Hall, 308 Harvard Street SE,, Minneapolis, MN 55455, USA.'}]",Research and theory for nursing practice,['10.1891/RTNP-2021-0111']
2132,35705234,Impact of a Wearable Activity Tracker on Disease Flares in Spondyloarthritis: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the impact of a wearable activity tracker used to encourage physical activity, on disease flares in spondyloarthritis patients.
METHODS


This randomized controlled trial involved randomizing 108 spondyloarthritis patients into tracker and non-tracker groups. The participants were then subjected to assessments of disease activity, performance (6-Minute Walk Test), and quality of life (Short-Form-36 Health Survey Questionnaire) at the 12 th , 24 th , and 36 th  week. The primary outcome of was the change in the frequency of flare episodes (categorized as no flare, flare in <3 days, and flare in >3 days) between baseline and 12 weeks.
RESULTS


The results of the study showed that at the 12 th  week, the mean change (Δ) of the number of flares improved in both groups: -0.32 (95% confidence interval (CI) -0.66, 0.02) and -0.38 (95% CI -0.68, 60.09) in the tracker and non-tracker group, respectively. However, the between-group differences were insignificant (p=0.87). Performance scores improved in both groups at the 12 th , 24 th , and 36 th  week (p<0.01, p<0.01, and p<0.01). The different dimensions of quality of life also improved at the 12 th  week (p<0.01). Conversely, moderate flares (p<0.01) and performance (p<0.01) improved over time; however, the influence of a wearable activity tracker was not significant (p=0.29 and p=0.66, respectively).
CONCLUSION


The use of a wearable activity tracker did not affect the number of flares, performance, and quality of life of spondyloarthritis patients. Nevertheless, this study confirmed the benefits of physical activity on flares, disease activity, quality of life, and physical performance in spondyloarthritis patients.",2022,"The use of a wearable activity tracker did not affect the number of flares, performance, and quality of life of spondyloarthritis patients.","['108 spondyloarthritis patients into tracker and non-tracker groups', 'Disease Flares in Spondyloarthritis', 'spondyloarthritis patients']","['wearable activity tracker', 'Wearable Activity Tracker']","['frequency of flare episodes (categorized as no flare, flare in <3 days, and flare', 'number of flares', 'flares, disease activity, quality of life, and physical performance', 'moderate flares (p<0.01) and performance (p<0.01) improved over time', 'quality of life', 'Performance scores', 'number of flares, performance, and quality of life of spondyloarthritis patients', 'disease activity, performance (6-Minute Walk Test), and quality of life (Short-Form-36 Health Survey Questionnaire', 'wearable activity tracker']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]",108.0,0.10744,"The use of a wearable activity tracker did not affect the number of flares, performance, and quality of life of spondyloarthritis patients.","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Labat', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Meggy', 'Initials': 'M', 'LastName': 'Hayotte', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bailly', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Fabre', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Brocq', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Gerus', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Breuil', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Manuella', 'Initials': 'M', 'LastName': 'Fournier-Mehouas', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Zory', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': ""D'Arripe-Longueville"", 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Roux', 'Affiliation': ""Université Côte d'Azur, Rheumatology department, CHU de Nice, France; LAMHESS, Université Côte d'Azur, Nice, France; Department of Public Health, University Hospital Centre Nice, Université Côte d'Azur, Nice, France; Rheumatology Department, CHPG Monaco, Monaco City, Monaco; IBV CNRS IMR 7277 INSERM U1091 UNS, University Côte d'Azur. Statement of Ethics and Consent: The protocol was approved by the local ethics review board and was performed according to the International Conference on Harmonization Good Clinical Practice Guideline and the Declaration of Helsinki. This trial was registered with ClinicalTrials.gov (NCT03458026). All patients provided written informed consent for participation in the study. Corresponding Author: CH Roux, Rheumatology Department, CHU de Nice, Hospital Pasteur 2, 30 voie Romaine, 06000 Nice, France. Email: roux.c2@chu-nice.fr.""}]",The Journal of rheumatology,['10.3899/jrheum.220140']
2133,35710091,"THE EFFECTS OF INSPIRATORY MUSCLE TRAINING VERSUS CALF MUSCLE TRAINING ON QUALITY OF LIFE, PAIN, VENOUS FUNCTION AND ACTIVITY IN PATIENTS WITH CHRONIC VENOUS INSUFFICIENCY.","OBJECTIVE


The aim of this study was to evaluate the effect of inspiratory muscle training(IMT) and calf muscle exercise training(ETC) in addition to compression therapy(CT) on quality of life, venous refilling time, disease severity, pain, edema, range of motion, muscle strength and functionality in patients with chronic venous insufficiency (CVI) compared to compression treatment alone.
METHODS


Thirty-two participants diagnosed with CVI were randomly divided into three groups. IMT in addition to compression therapy, Group 1, exercise training for the calf muscle in addition to compression therapy, Group 2, and compression therapy alone, Group 3. All the patients were assessed with the Chronic Venous Insufficiency Quality of Life Questionnaire-20, Nottingham Health Profile, photoplethysmography, venous clinical severity score, visual analog scale, intraoral pressure measurements, dynamometer, digital goniometer, 6-minute walk test and lower extremity functional scale.
RESULTS


After treatment, Group 2 improved more than groups 1 and 3 in terms of quality of life, venous refilling time, pain, edema, range of motion, muscle strength and functionality scores; Group 1 improved more than groups 2 and 3 in terms of disease severity, inspiratory and expiratory muscle strength values(p<0.05). Only physical mobility and right leg venous refilling time increased in group 3(p<0.05).
CONCLUSIONS


IMT and ETC improve venous function in both legs in patients with CVI while CT alone improves venous function only in the right leg of patients with CVI.",2022,"After treatment, Group 2 improved more than groups 1 and 3 in terms of quality of life, venous refilling time, pain, edema, range of motion, muscle strength and functionality scores; Group 1 improved more than groups 2 and 3 in terms of disease severity, inspiratory and expiratory muscle strength values(p<0.05).","['patients with chronic venous insufficiency (CVI', 'Thirty-two participants diagnosed with CVI']","['IMT', 'exercise training', 'inspiratory muscle training(IMT) and calf muscle exercise training(ETC', 'IMT and ETC', 'compression treatment alone', 'CT']","['quality of life, venous refilling time, pain, edema, range of motion, muscle strength and functionality scores', 'quality of life, venous refilling time, disease severity, pain, edema, range of motion, muscle strength and functionality', 'physical mobility and right leg venous refilling time', 'Chronic Venous Insufficiency Quality of Life Questionnaire-20, Nottingham Health Profile, photoplethysmography, venous clinical severity score, visual analog scale, intraoral pressure measurements, dynamometer, digital goniometer, 6-minute walk test and lower extremity functional scale', 'disease severity, inspiratory and expiratory muscle strength values(p<0.05', 'venous function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0230415', 'cui_str': 'Structure of right lower limb'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451339', 'cui_str': 'Nottingham health profile'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",32.0,0.0151057,"After treatment, Group 2 improved more than groups 1 and 3 in terms of quality of life, venous refilling time, pain, edema, range of motion, muscle strength and functionality scores; Group 1 improved more than groups 2 and 3 in terms of disease severity, inspiratory and expiratory muscle strength values(p<0.05).","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Aydin', 'Affiliation': 'Istanbul Okan University, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Istanbul, Turkey.'}, {'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Yeldan', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Istanbul, Turkey. Electronic address: ipek.yeldan@iuc.edu.tr.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Akgul', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Division of Gerontology, Istanbul, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Ipek', 'Affiliation': 'Istanbul University-Cerrahpasa, Medical Faculty of Cerrahpasa, Department of Cardiovascular Surgery, Istanbul, Turkey.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2022.04.012']
2134,35710085,Technology-enhanced AcceleRation of Germline Evaluation for Therapy (TARGET): A randomized controlled trial of a pretest patient-driven webtool vs. genetic counseling for prostate cancer germline testing.,"BACKGROUND


Germline testing has an increasingly important role in prostate cancer care. However, a relative shortage of genetic counselors necessitates alternate strategies for delivery of pre-test education for germline testing. This study, funded by the Prostate Cancer Foundation, seeks to address the need for novel methods of delivery of pre-test germline education beyond traditional germline counseling to facilitate informed patient decision-making for germline testing.
METHODS


This is a two-armed randomized controlled trial (RCT) with a target enrollment of 173 participants with prostate cancer per study arm (total anticipated n = 346). Patients who meet criteria for germline testing based on tumor features, family history or Ashkenazi Jewish ancestry are being recruited from 5 US sites including academic, private practice and Veterans healthcare settings. Consenting participants are randomized to the interactive pretest webtool or germline counseling with assessment of key patient-reported outcomes involved in informed decision-making for germline germline testing.
RESULTS


Participants complete surveys at baseline, after pretest education/counseling, and following disclosure of germline germline results. The primary outcome of the study is decisional conflict for germline testing. Secondary outcomes include germline knowledge, satisfaction, uptake of germline testing, and understanding of results.
CONCLUSION


Our hypothesis is that the web-based germline education tool is non-inferior to traditional germline counseling regarding key patient-reported outcomes involved in informed decision-making for germline testing. If proven, the results would support deploying the webtool across various practice settings to facilitate pre-test germlines education for individuals with prostate cancer and developing collaborative care strategies with germline counseling.
CLINICALTRIALS


gov Identifier: NCT04447703.",2022,Our hypothesis is that the web-based germline education tool is non-inferior to traditional germline counseling regarding key patient-reported outcomes involved in informed decision-making for germline testing.,"['Patients who meet criteria for germline testing based on tumor features, family history or Ashkenazi Jewish ancestry are being recruited from 5 US sites including academic, private practice and Veterans healthcare settings', 'individuals with prostate cancer', 'Consenting participants', '173 participants with prostate cancer per study arm (total anticipated n\u202f=\u202f346']","['interactive pretest webtool or germline counseling with assessment of key patient-reported outcomes involved in informed decision-making for germline germline testing', 'pretest patient-driven webtool vs. genetic counseling']","['germline knowledge, satisfaction, uptake of germline testing, and understanding of results', 'decisional conflict for germline testing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0022422', 'cui_str': 'Judaism'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}]",346.0,0.313236,Our hypothesis is that the web-based germline education tool is non-inferior to traditional germline counseling regarding key patient-reported outcomes involved in informed decision-making for germline testing.,"[{'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Loeb', 'Affiliation': 'NYU-Langone Health and NYU Perlmutter Cancer Center, New York, NY, United States of America; Manhattan Veteran Affairs, New York, NY, United States of America.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Cheng', 'Affiliation': 'Fred Hutchinson Cancer Center, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Leader', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gross', 'Affiliation': 'Cancer Risk Assessment and Clinical Cancer Germlines, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Tatiana Sanchez', 'Initials': 'TS', 'LastName': 'Nolasco', 'Affiliation': 'NYU-Langone Health and NYU Perlmutter Cancer Center, New York, NY, United States of America; Manhattan Veteran Affairs, New York, NY, United States of America.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Byrne', 'Affiliation': 'NYU-Langone Health and NYU Perlmutter Cancer Center, New York, NY, United States of America; Manhattan Veteran Affairs, New York, NY, United States of America.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Wise', 'Affiliation': 'NYU-Langone Health and NYU Perlmutter Cancer Center, New York, NY, United States of America.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Hollifield', 'Affiliation': 'NYU-Langone Health and NYU Perlmutter Cancer Center, New York, NY, United States of America.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Brown', 'Affiliation': 'Fred Hutchinson Cancer Center, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Slater', 'Affiliation': 'Prostate Cancer Foundation, Santa Monica, CA, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pieczonka', 'Affiliation': 'Associated Medical Professionals, Syracuse, NY, United States of America.'}, {'ForeName': 'Leonard G', 'Initials': 'LG', 'LastName': 'Gomella', 'Affiliation': 'Department of Urology, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Edouard J', 'Initials': 'EJ', 'LastName': 'Trabulsi', 'Affiliation': 'Department of Urology, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Handley', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Costas D', 'Initials': 'CD', 'LastName': 'Lallas', 'Affiliation': 'Department of Urology, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Thenappan', 'Initials': 'T', 'LastName': 'Chandrasekar', 'Affiliation': 'Department of Urology, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mille', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mann', 'Affiliation': 'Department of Urology, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'James Ryan', 'Initials': 'JR', 'LastName': 'Mark', 'Affiliation': 'Department of Urology, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': 'New Jersey Urology, Voorhees, NJ, United States of America.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Chopra', 'Affiliation': 'New Jersey Urology, Voorhees, NJ, United States of America.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Wasserman', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Somers', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Veda N', 'Initials': 'VN', 'LastName': 'Giri', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States of America; Cancer Risk Assessment and Clinical Cancer Germlines, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States of America; Department of Urology, Thomas Jefferson University, Philadelphia, PA, United States of America. Electronic address: Veda.Giri@jefferson.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106821']
2135,35710044,Visual Cues and Optimal Defaults in Fast-Food Combo Meals Benefit Health Concerned Consumers - A Randomized Scenario-Based Experiment.,"BACKGROUND


The use of low-calorie menu items as optimal defaults and visual cues may nudge consumers to healthier choices at restaurants. However, little is known regarding their effects on emotions and behavioral intentions, particularly among people with different levels of health concern.
OBJECTIVE


Evaluate optimal defaults and visual cues' effect on anticipated pleasure and order intention depending upon consumers' health concern level.
DESIGN


Between-subjects randomized scenario-based experiment.
PARTICIPANTS/SETTING


636 U.S. adults recruited through an online crowdsourcing platform in July 2020.
INTERVENTION


Participants saw one of six menu boards in a fast-food drive-thru simulation. Half the menu boards included meal photos with 1) menu items to be arranged as a combo by choice (i.e., create-your-own combo); 2) traditional combos that included high-calorie default items; or 3) optimal combos that included low-calorie default items. The remaining three boards were identical without photos.
MAIN OUTCOME MEASURES


Anticipated pleasure, order intention, and health concern were evaluated with 7-point Likert scales.
ANALYSIS


Statistical tests included multiple regression, Kruskal Wallis, Chi-Square, and analysis of variance. Education and sex were tested as potential confounders.
RESULTS


Optimal combos negatively affected anticipated pleasure (P=0.003) and order intention (P<0.001) compared to choice combos. Order intention reduction was the same for traditional and optimal combos (P=0.128). The presence of photos changed order intention for optimal combos but varied by consumer's health concern level. When health concern was lower, photos decreased the likelihood of ordering the optimal combos (B= -3.06, p=0.001), but when health concern was higher, photos enhanced ordering intention compared to the choice group (B= 0.60, p=0.001). The photos did not affect anticipated pleasure for any level of health concern.
CONCLUSIONS


The adverse effect of optimal defaults and how visual cues may reduce their negative effect should be considered in menu design.",2022,"RESULTS


Optimal combos negatively affected anticipated pleasure (P=0.003) and order intention (P<0.001) compared to choice combos.",['636 U.S. adults recruited through an online crowdsourcing platform in July 2020'],"['Participants saw one of six menu boards in a fast-food drive-thru simulation', 'traditional combos that included high-calorie default items; or 3) optimal combos that included low-calorie default items']","['Anticipated pleasure, order intention, and health concern', 'multiple regression, Kruskal Wallis, Chi-Square, and analysis of variance', 'pleasure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}]",,0.076963,"RESULTS


Optimal combos negatively affected anticipated pleasure (P=0.003) and order intention (P<0.001) compared to choice combos.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Diaz-Beltran', 'Affiliation': 'Assistant Professor, Nutrition and Biochemistry Department, Pontificia Universidad Javeriana, Cra. 7 No. 40 - 62, Bogota, Colombia. Electronic address: m-diazb@javeriana.edu.co.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Almanza', 'Affiliation': 'Emeritus Professor, School of Hospitality and Tourism Management, Purdue University, 900 W State St, West Lafayette, IN 47906.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Byrd', 'Affiliation': 'Assistant Professor, School of Hospitality and Tourism Management, Purdue University, 900 W State St, West Lafayette, IN 47906.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Behnke', 'Affiliation': 'Associate Professor, School of Hospitality and Tourism Management, Purdue University, 900 W State St, West Lafayette, IN 47906.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Nelson', 'Affiliation': 'Associate Professor, School of Hospitality and Tourism Management, Purdue University, 900 W State St, West Lafayette, IN 47906.'}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2022.06.004']
2136,35710043,"Fast-Food Optimal Defaults Reduce Calories Ordered, As Well As Dietary Autonomy: A Scenario-Based Experiment.","BACKGROUND


Low-calorie menu items as optimal defaults may encourage healthier choices when people eat out. Limited research has studied default effects from the restauranteurs' perspective, as well as the public health perspective.
OBJECTIVE


To examine the effects of optimal defaults on calories ordered, dietary autonomy, and visit intention in the context of a fast-food drive-thru.
DESIGN


Between-subjects randomized scenario-based experiment.
PARTICIPANTS/SETTING


377 adults who lived in the United States recruited through a crowdsourcing platform in July 2020.
INTERVENTION


Participants were asked to visualize ordering a combo meal in a fast-food drive-thru. They were randomly assigned to order from one of three menu boards: 1) menu items available for combos by customer choice; or 2) combos that included traditional high-calorie default items; or 3) combos that included low-calorie optimal defaults.
MAIN OUTCOME MEASURES


Differences in calories ordered among groups, dietary autonomy, and restaurant visit intention.
ANALYSIS


Statistical tests included multiple regression, Kruskal Wallis, Chi-Square, and One-way analysis of variance. Covariates such as education and sex were tested in regression models as potential confounders.
RESULTS


Compared to the choice combo meals, optimal combo meals reduced calories ordered by consumers (-337 Cal, SE=19, P< 0.001), while traditional combos increased them (+132 Cal, SE=20, P< 0.001). No significant difference was found in visit intention. Dietary autonomy was affected by the optimal defaults (P=0.025), even in participants with high health concern. Conversely, the traditional combos's effect on dietary autonomy was moderated by health concern (B= -0.26, P= 0.023), with only individuals with very high levels of health concern perceiving less autonomy.
CONCLUSIONS


Optimal defaults provided a robust reduction in calories ordered but had implications for dietary autonomy.",2022,"Dietary autonomy was affected by the optimal defaults (P=0.025), even in participants with high health concern.","['participants with high health concern', '377 adults who lived in the United States recruited through a crowdsourcing platform in July 2020']",['menu items available for combos by customer choice; or 2) combos that included traditional high-calorie default items; or 3) combos that included low-calorie optimal defaults'],"['Dietary autonomy', 'visit intention', 'multiple regression, Kruskal Wallis, Chi-Square, and One-way analysis of variance', 'dietary autonomy']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}]",377.0,0.0810629,"Dietary autonomy was affected by the optimal defaults (P=0.025), even in participants with high health concern.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Diaz-Beltran', 'Affiliation': 'Assistant Professor, Nutrition and Biochemistry Department, Pontificia Universidad Javeriana, Cra. 7 No. 40 - 62, Bogota, Colombia. Electronic address: m-diazb@javeriana.edu.co.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Almanza', 'Affiliation': 'Emeritus Professor, School of Hospitality and Tourism Management, Purdue University, 900 W State St, West Lafayette, IN 47906.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Byrd', 'Affiliation': 'Assistant Professor, School of Hospitality and Tourism Management, Purdue University, 900 W State St, West Lafayette, IN 47906.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Behnke', 'Affiliation': 'Associate Professor, School of Hospitality and Tourism Management, Purdue University, 900 W State St, West Lafayette, IN 47906.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Nelson', 'Affiliation': 'Associate Professor, School of Hospitality and Tourism Management, Purdue University, 900 W State St, West Lafayette, IN 47906.'}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2022.06.005']
2137,35709974,Outcomes with Heart Failure Management in a Multidisciplinary Clinic - A Randomized Controlled Trial.,,2022,,[],[],[],[],[],[],,0.388957,,"[{'ForeName': 'Bhagwati Prasad', 'Initials': 'BP', 'LastName': 'Pant', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. Electronic address: drbhagwatipant@gmail.com.'}, {'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Satheesh', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry.'}, {'ForeName': 'Ajith Ananthakrishna', 'Initials': 'AA', 'LastName': 'Pillai', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Anantharaj', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Ramamoorthy', 'Affiliation': 'Department of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Selvaraj', 'Affiliation': 'Department of Cardiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry.'}]",Indian heart journal,['10.1016/j.ihj.2022.06.005']
2138,35710444,Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial.,"BACKGROUND


Women in Africa face disproportionate risk of human immunodeficiency virus (HIV) acquisition, accounting for more than half of new infections in Africa and similarly face a disproportionate burden of sexually transmitted infections (STIs). Very high STI prevalence is being observed globally, especially among people taking pre-exposure prophylaxis (PrEP) for HIV prevention. Doxycycline post-exposure prophylaxis (dPEP) has been proposed as an STI prevention strategy to reduce chlamydia, syphilis, and possibly gonorrhea, and trials are ongoing among cisgender men who have sex with men (MSM) and transgender women who are taking PrEP in high-income settings. We designed and describe here the first open-label trial to determine the effectiveness of dPEP to reduce STI incidence among cisgender women.
METHODS


We are conducting an open-label 1:1 randomized trial of dPEP versus standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 Kenyan women aged ≥ 18 and ≤ 30 years old women taking PrEP. Women are followed for 12 months, with quarterly STI testing, treatment, and adherence counseling. The primary trial outcome will be the combined incidence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Treponema pallidum, compared between the randomized groups. We will also assess dPEP acceptability, tolerability, safety, impact on sexual behavior, adherence, and occurrence of antimicrobial resistance (AMR) in N. gonorrhoeae and C. trachomatis isolates. Finally, we will estimate cost per incident STI case and complications averted accounting for nonadherence and benefits relative AMR or side effects.
DISCUSSION


The results of this trial may have immediate implications for the global epidemic of STIs and sexual health. If effective, dPEP could put STI prevention into women's hands. While dPEP may be able to prevent STIs, it carries important risks that could counter its benefits; global debate about the balance of these potential risks and benefits requires data to inform policy and implementation and our study aims to fill this gap.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04050540 .",2022,"Very high STI prevalence is being observed globally, especially among people taking pre-exposure prophylaxis (PrEP) for HIV prevention.","['Kenyan women using HIV pre-exposure prophylaxis', '≤\u200930\xa0years old women taking PrEP', 'cisgender men who have sex with men (MSM) and transgender women who are taking PrEP in high-income settings', 'cisgender women', '446 Kenyan women aged\u2009≥\u200918 and']","['Doxycycline post-exposure prophylaxis (dPEP', 'dPEP', 'dPEP versus standard of care (STI screening and treatment and risk-reduction counseling without dPEP', 'Doxycycline post-exposure prophylaxis']","['combined incidence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Treponema pallidum', 'STI incidence', 'dPEP acceptability, tolerability, safety, impact on sexual behavior, adherence, and occurrence of antimicrobial resistance (AMR']","[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0948433', 'cui_str': 'High income'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0027573', 'cui_str': 'Neisseria gonorrhoeae'}, {'cui': 'C0040840', 'cui_str': 'Treponema pallidum'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",446.0,0.0741031,"Very high STI prevalence is being observed globally, especially among people taking pre-exposure prophylaxis (PrEP) for HIV prevention.","[{'ForeName': 'Jenell', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA. jenells@uw.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}, {'ForeName': 'Fredericka A', 'Initials': 'FA', 'LastName': 'Sesay', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Oware', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}, {'ForeName': 'Olusegun O', 'Initials': 'OO', 'LastName': 'Soge', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Odoyo', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Kwena', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.'}, {'ForeName': 'Caitlin W', 'Initials': 'CW', 'LastName': 'Scoville', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Violette', 'Affiliation': 'Department of Medicine (Infectious Diseases), University of Washington, Seattle, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morrison', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Simoni', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'McClelland', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}, {'ForeName': 'Ruanne', 'Initials': 'R', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California San Francisco, San Francisco, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Box 359931, 325 Ninth Ave, WA, 98104, Seattle, USA.'}]",Trials,['10.1186/s13063-022-06458-8']
2139,35710440,"A randomized, placebo-controlled, double-blinded trial of MRSA throat carriage treatment, with either standard decolonization alone or in combination with oral clindamycin.","BACKGROUND


Staphylococcus aureus is a frequent colonizer of the human skin and mucous membranes but can also cause a variety of serious infections. Antimicrobial resistance is an increasing worldwide challenge and is mainly driven by an overuse of antimicrobials. To avoid the spread of methicillin-resistant Staphylococcus aureus (MRSA) in Denmark, the Danish Health Authority recommends decolonization treatment of MRSA carriers and their household contacts. Standard decolonization treatment includes chlorhexidine body wash and mupirocin nasal ointment, especially throat carriage is difficult to treat. The broad-spectrum antibiotic, clindamycin, is often added to the decolonization treatment, but there is currently low scientific evidence for this treatment.
AIM


To investigate whether the addition of clindamycin to the standard decolonization treatment increases decolonization success in MRSA throat carriers.
METHODS


A randomized, placebo-controlled, double-blinded trial, including patients ≥ 18 years, who tested MRSA positive in the throat after completing one standard decolonization treatment. All carriers included in the trial receive standard decolonization treatment and are randomized to treatment with either placebo or clindamycin capsules for 10 days. We plan to include 40 participants in each of the two treatment arms.
DISCUSSION


Due to the lack of consistent scientific evidence of clindamycin's effect in MRSA decolonization and the worldwide urgent need to reduce the use of antibiotics, we judged that a 30% increase in the decolonization success rate in carriers treated with clindamycin is appropriate to justify prescribing clindamycin as part of the decolonization treatment of asymptomatic MRSA carriers.
TRIAL REGISTRATION


EudraCT number 2019-002631-29.",2022,"AIM


To investigate whether the addition of clindamycin to the standard decolonization treatment increases decolonization success in MRSA throat carriers.
","['patients ≥ 18 years, who tested MRSA positive in the throat after completing one standard decolonization treatment', '40 participants in each of the two treatment arms', 'MRSA throat carriers']","['standard decolonization alone or in combination with oral clindamycin', 'chlorhexidine', 'placebo or clindamycin', 'clindamycin', 'placebo']","['decolonization success', 'decolonization success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0729578', 'cui_str': 'Methicillin resistant staphylococcus aureus positive'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0343401', 'cui_str': 'Methicillin resistant Staphylococcus aureus infection'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C0360335', 'cui_str': 'Clindamycin-containing product in oral dose form'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}]","[{'cui': 'C4520447', 'cui_str': 'Decolonization'}]",,0.352763,"AIM


To investigate whether the addition of clindamycin to the standard decolonization treatment increases decolonization success in MRSA throat carriers.
","[{'ForeName': 'Mona Katrine Alberthe', 'Initials': 'MKA', 'LastName': 'Holm', 'Affiliation': 'Department of Clinical Microbiology, Copenhagen University Hospital Amager and Hvidovre, Kettegaard alle 30, 2650 Hvidovre, Copenhagen, Denmark. mona.katrine.alberthe.holm@regionh.dk.'}, {'ForeName': 'Heidi Karin', 'Initials': 'HK', 'LastName': 'Meiniche', 'Affiliation': 'Department of Clinical Microbiology, Copenhagen University Hospital Amager and Hvidovre, Kettegaard alle 30, 2650 Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Department of Clinical Microbiology, Copenhagen University Hospital Amager and Hvidovre, Kettegaard alle 30, 2650 Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Helle Brander', 'Initials': 'HB', 'LastName': 'Eriksen', 'Affiliation': 'Department of Clinical Microbiology, Copenhagen University Hospital Herlev and Gentofte, Herlev, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Westh', 'Affiliation': 'Department of Clinical Microbiology, Copenhagen University Hospital Amager and Hvidovre, Kettegaard alle 30, 2650 Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Holzknecht', 'Affiliation': 'Department of Clinical Microbiology, Copenhagen University Hospital Herlev and Gentofte, Herlev, Denmark.'}, {'ForeName': 'Mette Damkjær', 'Initials': 'MD', 'LastName': 'Bartels', 'Affiliation': 'Department of Clinical Microbiology, Copenhagen University Hospital Amager and Hvidovre, Kettegaard alle 30, 2650 Hvidovre, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-022-06443-1']
2140,35710437,"Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial.","BACKGROUND


Treatment fidelity is inconsistently reported in aphasia research, contributing to uncertainty about the effectiveness of types of aphasia therapy following stroke. We outline the processes and outcomes of treatment fidelity monitoring in a pre-specified secondary analysis of the VERSE trial.
METHODS


VERSE was a 3-arm, single-blinded RCT with a 12-week primary endpoint comparing Usual Care (UC) to two higher intensity treatments: Usual Care-Plus (UC-Plus) and VERSE, a prescribed intervention. Primary outcome results were previously reported. This secondary analysis focused on treatment fidelity. Video-recorded treatment sessions in the higher intensity study arms were evaluated for treatment adherence and treatment differentiation. Treatment components were evaluated using a pre-determined fidelity checklist.
PRIMARY OUTCOME


prescribed amount of therapy time (minutes); secondary outcomes: (i) adherence to therapy protocol (%) and (ii) treatment differentiation between control and high intensity groups.
RESULTS


Two hundred forty-six participants were randomised to Usual Care (n=81), Usual Care-Plus (n=82), and VERSE (n=83). One hundred thirty-five (82%) participants in higher intensity intervention arms received the minimum prescribed therapy minutes. From 10,805 (UC 7787; UC-Plus 1450; VERSE 1568) service events, 431 treatment protocol deviations were noted in 114 participants. Four hundred thirty-seven videos were evaluated. The VERSE therapists achieved over 84% adherence to key protocol elements. Higher stroke and aphasia severity, older age, and being in the UC-Plus group predicted more treatment deviations.
CONCLUSIONS


We found high levels of treatment adherence and differentiation between the intervention arms, providing greater confidence interpreting our results. The comprehensive systems for intervention fidelity monitoring and reporting in this trial make an important contribution to aphasia research and, we argue, should set a new standard for future aphasia studies.
TRIAL REGISTRATION


ACTRN 12613000776707.",2022,"Higher stroke and aphasia severity, older age, and being in the UC-Plus group predicted more treatment deviations.
","['Two hundred forty-six participants', 'Four hundred thirty-seven videos were evaluated', '114 participants']","['Usual Care-Plus (n=82), and VERSE', 'Usual Care (UC) to two higher intensity treatments: Usual Care-Plus (UC-Plus) and VERSE, a prescribed intervention', 'Usual Care']",['amount of therapy time (minutes); secondary outcomes: (i) adherence to therapy protocol (%) and (ii) treatment differentiation between control and high intensity groups'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042553', 'cui_str': 'Versed'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",246.0,0.0578534,"Higher stroke and aphasia severity, older age, and being in the UC-Plus group predicted more treatment deviations.
","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Godecke', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Dve, Joondalup, Western Australia, 6027, Australia. e.godecke@ecu.edu.au.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Brogan', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Dve, Joondalup, Western Australia, 6027, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ciccone', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Dve, Joondalup, Western Australia, 6027, Australia.'}, {'ForeName': 'Miranda L', 'Initials': 'ML', 'LastName': 'Rose', 'Affiliation': 'Centre of Research Excellence in Aphasia Rehabilitation Recovery, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Armstrong', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Dve, Joondalup, Western Australia, 6027, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Whitworth', 'Affiliation': 'Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Ellery', 'Affiliation': 'Stroke Division, The Florey Institute of Neuroscience and Mental Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Holland', 'Affiliation': 'University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': 'Centre of Research Excellence in Aphasia Rehabilitation Recovery, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Rai', 'Affiliation': 'University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'School of Medicine and Pharmacology, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Cadilhac', 'Affiliation': 'Centre of Research Excellence in Aphasia Rehabilitation Recovery, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': 'Centre of Research Excellence in Aphasia Rehabilitation Recovery, Melbourne, Victoria, Australia.'}]",Trials,['10.1186/s13063-022-06433-3']
2141,35710428,Qatar Diabetes Mobile Application Trial (QDMAT): an open-label randomised controlled trial to examine the impact of using a mobile application to improve diabetes care in type 2 diabetes mellitus-a study protocol.,"BACKGROUND


Mobile health (mHealth) is increasingly advocated for diabetes management. It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with type 2 diabetes (T2DM). A new mobile application was specifically built for people with T2DM with the help of the local expertise. The objective of the study was to evaluate the effectiveness of the mobile app.
METHODS


The planned study is an ongoing open-label randomised controlled trial in which adults living with T2DM treated with insulin will be randomised 1:1 to the use of this diabetes application versus current standard care. The primary outcome will be the difference in mean HbA1c from baseline to 6 months. Other outcome measures include anthropometric measures, hypoglycaemic events, medication adjustments, number of clinical interactions and missed appointments and patient perceptions of their disease and diabetes self-management. The study will randomise 180 subjects for assessment of the primary outcome.
DISCUSSION


We hypothesise that the diabetes-specific mobile application will improve glycaemic control, increase patient empowerment for self-management of diabetes and improve interaction between patients and healthcare providers. If the Qatar Diabetes Mobile Application Trial (QDMAT) demonstrates this, it will inform clinical services for the future self-management of T2DM.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03998267 . Registered on 26 June 2019.",2022,"It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with type 2 diabetes (T2DM).","['180 subjects for assessment of the primary outcome', 'people with T2DM with the help of the local expertise', 'adults living with T2DM treated with insulin', 'patients with type 2 diabetes (T2DM']",[],"['anthropometric measures, hypoglycaemic events, medication adjustments, number of clinical interactions and missed appointments and patient perceptions of their disease and diabetes self-management', 'glycaemic control, clinical outcomes, quality of life and overall patient satisfaction', 'mean HbA1c']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.19495,"It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with type 2 diabetes (T2DM).","[{'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Suleiman', 'Affiliation': 'Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar. noorsuleiman@gmail.com.'}, {'ForeName': 'Meis', 'Initials': 'M', 'LastName': 'Alkasem', 'Affiliation': 'Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Zaina', 'Initials': 'Z', 'LastName': 'Al Amer', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Obada', 'Initials': 'O', 'LastName': 'Salameh', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Al-Thani', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Mohammad Khair', 'Initials': 'MK', 'LastName': 'Hamad', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Baagar', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Ibrahem', 'Initials': 'I', 'LastName': 'Abdalhakam', 'Affiliation': 'Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Othman', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Ragae', 'Initials': 'R', 'LastName': 'Dughmosh', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Dabia', 'Initials': 'D', 'LastName': 'Al-Mohanadi', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Sanousi', 'Affiliation': 'Clinical Information Systems Department, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Bashir', 'Affiliation': 'Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Chagoury', 'Affiliation': 'Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Shahrad', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Abdul-Badi', 'Initials': 'AB', 'LastName': 'Abou-Samra', 'Affiliation': 'Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}]",Trials,['10.1186/s13063-022-06334-5']
2142,35710395,"No effects of a 4-week post-exercise sauna bathing on targeted gut microbiota and intestinal barrier function, and hsCRP in healthy men: a pilot randomized controlled trial.","BACKGROUND


Body temperature fluctuations induced by acute exercise bouts may influence the intestinal barrier with related effects on epithelial permeability, immune responses, and release of metabolites produced by the gut microbiota. This study evaluated the effects of post-exercise sauna bathing in young men undergoing endurance training on gut bacteria inflammation and intestinal barrier function.
METHODS


Fifteen (15) untrained males aged 22 ± 1.5 years were randomly assigned to exercise training (ET) with or without post-exercise sauna treatments (S). Participants in the group ET + S (n = 8) exercised 60 min, 3 times per week, on a bicycle ergometer followed by a 30-min dry Finish sauna treatment. The control group (ET, n = 7) engaged in the same exercise training program without the sauna treatments. Blood and stool samples were collected before and after the 4-week training program. Blood samples were analysed for the concentration of high-sensitivity C-reactive protein (hsCRP) and complete blood counts. Stool samples were analysed for pH, quantitative and qualitative measures of targeted bacteria, zonulin, and secretory immunoglobulin A.
RESULTS


Interaction effects revealed no differences in the pattern of change over time between groups for the abundance of selected gut microbiome bacteria and stool pH, zonulin, sIgA, and hsCRP. Pre- and post-study fecal concentrations of Bifidobacterium spp., Faecalibacterium prausnitzii, and Akkermansia muciniphila were below reference values for these bacteria in both groups.
CONCLUSIONS


The combination of 4-weeks exercise followed by passive heat exposure did not have a measurable influence on targeted gut microbiota, intestinal barrier function, and hsCRP levels in young males.
TRIAL REGISTRATION


The study was retrospectively registered in the clinical trials registry (Clinicaltrials.gov) under the trial registration number: NCT05277597. Release Date: March 11, 2022.",2022,"The combination of 4-weeks exercise followed by passive heat exposure did not have a measurable influence on targeted gut microbiota, intestinal barrier function, and hsCRP levels in young males.
","['young men undergoing', 'young males', 'Fifteen (15) untrained males aged 22\u2009±', '1.5\xa0years', 'healthy men']","['4-week post-exercise sauna bathing', 'post-exercise sauna bathing', 'exercise training (ET) with or without post-exercise sauna treatments (S', 'endurance training', 'Bifidobacterium spp', 'bicycle ergometer followed by a 30-min dry Finish sauna treatment', 'exercise training program without the sauna treatments']","['Blood and stool samples', 'targeted gut microbiota, intestinal barrier function, and hsCRP levels', 'concentration of high-sensitivity C-reactive protein (hsCRP) and complete blood counts']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0004836', 'cui_str': 'Sauna'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}]",,0.0182356,"The combination of 4-weeks exercise followed by passive heat exposure did not have a measurable influence on targeted gut microbiota, intestinal barrier function, and hsCRP levels in young males.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Karolkiewicz', 'Affiliation': 'Department of Food and Nutrition, Poznan University of Physical Education, Poznań, Poland. karolkiewicz@awf.poznan.pl.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Nieman', 'Affiliation': 'Department of Biology, Appalachian State University, North Carolina Research Campus, Kannapolis, NC, USA.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Cisoń', 'Affiliation': 'Department of Physiotherapy, Institute of Physical Education, State University of Applied Sciences in Nowy Sącz, Nowy Sącz, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Szurkowska', 'Affiliation': 'Department of Food and Nutrition, Poznan University of Physical Education, Poznań, Poland.'}, {'ForeName': 'Mirosława', 'Initials': 'M', 'LastName': 'Gałęcka', 'Affiliation': 'Institute of Microecology, Poznań, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Sitkowski', 'Affiliation': 'Department of Physiology, Institute of Sport - National Research Institute PL, Warsaw, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Szygula', 'Affiliation': 'Department of Sports Medicine and Human Nutrition, University of Physical Education, Kraków, Poland.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-022-00497-z']
2143,35710394,The clinical effectiveness and cost-effectiveness of a 'stepping into day treatment' approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial.,"BACKGROUND


Anorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a 'step-down' treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation.
METHODS


386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m 2  and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden.
DISCUSSION


The results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision.
TRIAL REGISTRATION


ISRCTN ISRCTN10166784 . Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.",2022,"Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown.","['anorexia nervosa in adult specialist eating disorder services', 'adults with severe AN', '386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m 2  and in need of intensive treatment']","[""stepping into day treatment' approach versus inpatient treatment"", 'inpatient treatment as usual or a stepped care day patient approach']","['psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden', 'clinical effectiveness and cost-effectiveness', 'BMI', 'effectiveness and cost-effectiveness']","[{'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",386.0,0.124765,"Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown.","[{'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Irish', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Dalton', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Potts', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'McCombie', 'Affiliation': ""Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ""Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Au', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Kern', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Clark-Stone', 'Affiliation': 'Gloucestershire Health and Care NHS Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Connan', 'Affiliation': 'Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'A Louise', 'Initials': 'AL', 'LastName': 'Johnston', 'Affiliation': 'NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Stanimira', 'Initials': 'S', 'LastName': 'Lazarova', 'Affiliation': ""South West London and St George's Mental Health NHS Trust, London, UK.""}, {'ForeName': 'Shiona', 'Initials': 'S', 'LastName': 'Macdonald', 'Affiliation': 'NHS Dumfries and Galloway, Dumfries, UK.'}, {'ForeName': 'Ciarán', 'Initials': 'C', 'LastName': 'Newell', 'Affiliation': 'Dorset HealthCare University NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Tayeem', 'Initials': 'T', 'LastName': 'Pathan', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, Leatherhead, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Wales', 'Affiliation': 'Leicestershire Adult Eating Disorders Service, Leicestershire Partnership NHS Trust, Bennion Centre, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cashmore', 'Affiliation': 'Leicestershire Adult Eating Disorders Service, Leicestershire Partnership NHS Trust, Bennion Centre, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Marshall', 'Affiliation': 'Leicestershire Adult Eating Disorders Service, Leicestershire Partnership NHS Trust, Bennion Centre, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Arcelus', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Jubilee Campus, Triumph Road, Nottingham, NG7 2TU, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Robinson', 'Affiliation': 'Division of Medicine, University College London, 5 University Street, London, WC1E, 6JF, UK.'}, {'ForeName': 'Hubertus', 'Initials': 'H', 'LastName': 'Himmerich', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Vanessa C', 'Initials': 'VC', 'LastName': 'Lawrence', 'Affiliation': ""Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. ulrike.schmidt@kcl.ac.uk.""}]",Trials,['10.1186/s13063-022-06386-7']
2144,35710339,Automated versus conventional perioperative glycemic control in adult diabetic patients undergoing open heart surgery.,"BACKGROUND


Intraoperative glycemic variability is associated with increased risks of mortality and morbidity and an increased incidence of hyperglycemia after cardiac surgery. Accordingly, clinicians tend to use a tight glucose control to maintain perioperative blood glucose levels and therefore the need to develop a less laborious automated glucose control system is important especially in diabetic patients at a higher risk of developing complications.
METHODS


Patients, aged between 40 and 75 years old, undergoing open heart surgery were randomized to either an automated protocol (experimental) or to the conventional technique at our institution (control).
RESULTS


We showed that the percentage of patients maintained between 7.8-10 mmol.l -1  was not statistically different between the two groups, however, through an additional analysis, we showed that the proportion of patients whose glucose levels maintained between a safety level of 6.7-10 mmol.l -1  was significantly higher in the experimental group compared to control group, 14 (26.7%) vs 5 (17.2%) P = 0.025. In addition, the percentage of patients who had at least one intraoperative hyperglycemic event was significantly higher in the control group compared to the experimental group, 17 (58.6%) vs 5 (16.7%), P < 0.001 with no hypoglycemic events in the experimental group compared to two events in the control group. We also showed that longer surgeries can benefit more from using the automated glucose control system, particularly surgeries lasting more than 210 min.
CONCLUSION


We concluded that the automated glucose control pump in diabetic patients undergoing open heart surgeries maintained most of the patients within a predefined glucose range with a very low incidence of hyperglycemic events and no incidence of hypoglycemic events.
TRIAL REGISTRATION


Registered with clinicaltrials.gov (NCT # NCT03314272 , Principal investigator Roland Kaddoum, date of registration: 19/10/2017).",2022,"In addition, the percentage of patients who had at least one intraoperative hyperglycemic event was significantly higher in the control group compared to the experimental group, 17 (58.6%) vs 5 (16.7%), P < 0.001 with no hypoglycemic events in the experimental group compared to two events in the control group.","['adult diabetic patients undergoing open heart surgery', 'diabetic patients', 'diabetic patients undergoing open heart surgeries', 'Patients, aged between 40 and 75\xa0years old, undergoing open heart surgery']","['automated protocol (experimental) or to the conventional technique at our institution (control', 'conventional perioperative glycemic control']","['intraoperative hyperglycemic event', 'hypoglycemic events', 'safety level', 'hyperglycemic events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0963986,"In addition, the percentage of patients who had at least one intraoperative hyperglycemic event was significantly higher in the control group compared to the experimental group, 17 (58.6%) vs 5 (16.7%), P < 0.001 with no hypoglycemic events in the experimental group compared to two events in the control group.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kaddoum', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Amro', 'Initials': 'A', 'LastName': 'Khalili', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Fadia M', 'Initials': 'FM', 'LastName': 'Shebbo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Ghanem', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Layal Abou', 'Initials': 'LA', 'LastName': 'Daher', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Arwa Bou', 'Initials': 'AB', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Nour El Hage', 'Initials': 'NEH', 'LastName': 'Chehade', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Maroun', 'Affiliation': 'Faculty of Medicine, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Aouad', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, American University of Beirut Medical Center, Beirut, Lebanon. mm01@aub.edu.lb.'}]",BMC anesthesiology,['10.1186/s12871-022-01721-6']
2145,35710336,A pragmatic effectiveness-implementation study comparing trial evidence with routinely collected outcome data for patients receiving the REACH-HF home-based cardiac rehabilitation programme.,"BACKGROUND


Cardiac rehabilitation for heart failure continues to be greatly underused worldwide despite being a Class I recommendation in international clinical guidelines and uptake is low in women and patients with mental health comorbidities.
METHODS


Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) programme was implemented in four UK National Health Service early adopter sites ('Beacon Sites') between June 2019 and June 2020. Implementation and patient-reported outcome data were collected across sites as part of the National Audit of Cardiac Rehabilitation. The change in key outcomes before and after the supervised period of REACH-HF intervention across the Beacon Sites was assessed and compared to those of the intervention arm of the REACH-HF multicentre trial.
RESULTS


Compared to the REACH-HF multicentre trial, patients treated at the Beacon Site were more likely to be female (33.8% vs 22.9%), older (75.6 vs 70.1), had a more severe classification of heart failure (26.5% vs 17.7%), had poorer baseline health-related quality of life (MLHFQ score 36.1 vs 31.4), were more depressed (HADS score 6.4 vs 4.1) and anxious (HADS score 7.2 vs 4.7), and had lower exercise capacity (ISWT distance 190 m vs 274.7 m). There appeared to be a substantial heterogeneity in the implementation process across the four Beacon Sites as evidenced by the variation in levels of patient recruitment, operationalisation of the REACH-HF intervention and patient outcomes. Overall lower improvements in patient-reported outcomes at the Beacon Sites compared to the trial may reflect differences in the population studied (having higher morbidity at baseline) as well as the marked challenges in intervention delivery during the COVID-19 pandemic.
CONCLUSION


The results of this study illustrate the challenges in consistently implementing an intervention (shown to be clinically effective and cost-effective in a multicentre trial) into real-world practice, especially in the midst of a global pandemic. Further research is needed to establish the real-world effectiveness of the REACH-HF intervention in different populations.",2022,"There appeared to be a substantial heterogeneity in the implementation process across the four Beacon Sites as evidenced by the variation in levels of patient recruitment, operationalisation of the REACH-HF intervention and patient outcomes.","['Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) programme was implemented in four UK National Health Service', 'patients receiving the REACH-HF home-based cardiac rehabilitation programme', 'women and patients with mental health comorbidities']",[],"['lower exercise capacity', 'severe classification of heart failure', 'poorer baseline health-related quality of life (MLHFQ score']","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0909438,"There appeared to be a substantial heterogeneity in the implementation process across the four Beacon Sites as evidenced by the variation in levels of patient recruitment, operationalisation of the REACH-HF intervention and patient outcomes.","[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Daw', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK. pxd891@student.bham.ac.uk.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Harrison', 'Affiliation': 'Health Sciences, University of York, York, UK.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Doherty', 'Affiliation': 'Health Sciences, University of York, York, UK.'}, {'ForeName': 'Jet J C S Veldhuijzen', 'Initials': 'JJCSV', 'LastName': 'van Zanten', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Hasnain M', 'Initials': 'HM', 'LastName': 'Dalal', 'Affiliation': 'University of Exeter Medical School, Royal Cornwall Hospital, Truro, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Samantha B', 'Initials': 'SB', 'LastName': 'van Beurden', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sinéad T J', 'Initials': 'STJ', 'LastName': 'McDonagh', 'Affiliation': ""Primary Care Research Group, College of Medicine and Health, University of Exeter, St Luke's Campus, Exeter, UK.""}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}]",BMC cardiovascular disorders,['10.1186/s12872-022-02707-5']
2146,35710241,Effectiveness of a web-based virtual journal club to promote medical education (Web-Ed): protocol of a multicentre pragmatic randomised trial.,"INTRODUCTION


A journal club (JC) is a commonly used medical educational tool. Videoconferencing technology can facilitate the delivery of JCs, however, there remains no evidence on the role of web-based virtual JCs in promoting the acquisition and retention of medical knowledge. The Web-Ed trial aims to evaluate the educational benefits, feasibility and acceptability of web-based virtual JCs compared with traditional face-to-face ones.
METHODS AND ANALYSIS


Web-Ed is a multicentre pragmatic parallel-group randomised trial across teaching hospitals within the UK National Health Service (NHS). We will enrol qualified doctors or medical students who are >18 years old, proficient in English and able to use online videoconferencing software. Block randomisation will be used to allocate participants in 1:1 ratio to either intervention group. Both groups will be presented with the same educational material and follow a standardised JC structure hosted by nominated moderators and medical faculty members.The primary outcome is the difference in participants' knowledge acquisition and retention 7 days after the JCs evaluated using standardised multiple-choice questions. We will report secondarily on the feasibility and acceptability of the JCs using Likert scale questionnaires. Assuming a 30% drop-out rate, we aim to enrol 75 participants to detect a 20% improvement in knowledge acquisition at 80% power and 5% significance. We will report using mean difference or risk ratio with 95% CIs and assess significance using parametric/non-parametric testing. Where relevant, we will adjust for predetermined characteristics (age, grade of training and session duration) using multivariate regression analyses.
ETHICS AND DISSEMINATION


Web-Ed was designed by doctors in training to address their learning needs and evaluate the preferred mode of learning. The trial results will be published in peer-reviewed journals and presented at relevant scientific conferences. The trial has been approved by the NHS Health Regulation Authority (21/HRA/3361).
TRIAL REGISTRATION NUMBER


ISRCTN18036769.",2022,The primary outcome is the difference in participants' knowledge acquisition and retention 7 days after the JCs evaluated using standardised multiple-choice questions.,"['enrol qualified doctors or medical students who are >18 years old, proficient in English and able to use online videoconferencing software', 'teaching hospitals within the UK National Health Service (NHS']","['Videoconferencing technology', 'web-based virtual journal club to promote medical education', 'web-based virtual JCs']","['knowledge acquisition', 'educational benefits, feasibility and acceptability', ""participants' knowledge acquisition and retention 7\u2009days after the JCs evaluated using standardised multiple-choice questions""]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4534427', 'cui_str': 'Proficient in English'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",,0.0972641,The primary outcome is the difference in participants' knowledge acquisition and retention 7 days after the JCs evaluated using standardised multiple-choice questions.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rimmer', 'Affiliation': 'MRC Centre for Reproductive Health, Queens Medical Research Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nagla', 'Initials': 'N', 'LastName': 'Elfaki', 'Affiliation': 'Reproductive Medicine Unit, University College London, London, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Dunlop', 'Affiliation': 'Obstetrics and Gynaecology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Coleburt', 'Affiliation': 'Musgrove Park Hospital, Somerset NHS Foundation Trust, Taunton, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Cowan', 'Affiliation': 'Wishaw University Hospital, NHS Lanarkshire, Bothwell, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Raglan', 'Affiliation': 'Hillingdon Hospital NHS Trust, Uxbridge, UK.'}, {'ForeName': 'Jhia Jiat', 'Initials': 'JJ', 'LastName': 'Teh', 'Affiliation': 'Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mcrobbie', 'Affiliation': 'Aberdeen Maternity Hospital, Aberdeen, UK.'}, {'ForeName': 'Nilaani', 'Initials': 'N', 'LastName': 'Murugesu', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Ramcharn', 'Affiliation': 'University Hospital of Wales Healthcare NHS Trust, Cardiff, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelrahman', 'Affiliation': 'Burnley General Hospital, Burnley, UK.'}, {'ForeName': 'Yazid', 'Initials': 'Y', 'LastName': 'Jibrel', 'Affiliation': 'Obstetrics and Gynaecology, Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wood', 'Affiliation': 'Obstetrics and Gynaecology, Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Parry-Smith', 'Affiliation': 'Obstetrics and Gynaecology, Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, UK.'}, {'ForeName': 'Bassel H', 'Initials': 'BH', 'LastName': 'Al Wattar', 'Affiliation': 'Reproductive Medicine Unit, University College London, London, UK dr.basselwa@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2021-058610']
2147,35710235,Tailored exercise and manual therapy versus standardised exercise for patients with shoulder subacromial pain: a feasibility randomised controlled trial (the Otago MASTER trial).,"OBJECTIVES


The aim of this study was to assess whether it was feasible to conduct a full trial comparing a tailored versus a standardised exercise programme for patients with shoulder subacromial pain.
DESIGN


Two-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial.
METHODS


Twenty-eight participants with shoulder subacromial pain were randomly allocated into one of two intervention groups-tailored or standardised exercise. Participants in the tailored exercise programme received exercises and manual therapy tailored to their scapular and shoulder movement impairments. Participants in the standardised exercise programme received progressive strengthening exercise. The primary outcome measures were (1) the participant recruitment rate; (2) the proportion of participants enrolled from the total number screened; (3) drop-out rates; and (4) adherence to the rehabilitation programme. Other outcome measures were: (5) pain levels; (6) Patient-Specific Functional Scale; (7) the Shoulder Pain and Disability Index; and (8) pain self-efficacy. We compared changes in pain and disability scores between groups using a repeated mixed-model analysis of variance. Since this is a feasibility study, we did not adjust alpha for multiple comparisons, and considered 75% CI as the probability threshold at 3-month follow-up. Health-related quality of life was assessed using the Short-Form 12 and quality-adjusted life years (QALYs) were estimated.
RESULTS


The recruitment rate was 3 participants per month, the proportion of participants enrolled was 23%, the drop-out rate was 14% and the overall adherence to the rehabilitation programme was 85%. No between-group differences were found for most outcome measures. Adverse events (n=2, only in the tailored group) were minor in nature and included skin injury or pain following taping.
CONCLUSIONS


Our feasibility trial showed that additional strategies are required for improving recruitment, enrolment and minimising drop-out of participants into the trial and making it feasible to conduct a full trial.
TRIAL REGISTRATION NUMBER


ANZCTR: 12617001405303.",2022,"Health-related quality of life was assessed using the Short-Form 12 and quality-adjusted life years (QALYs) were estimated.
","['Twenty-eight participants with shoulder subacromial pain', 'patients with shoulder subacromial pain']","['standardised exercise programme received progressive strengthening exercise', 'intervention groups-tailored or standardised exercise', 'Tailored exercise and manual therapy versus standardised exercise', 'tailored exercise programme received exercises and manual therapy tailored to their scapular and shoulder movement impairments', 'standardised exercise programme']","['Health-related quality of life', 'recruitment rate', 'Adverse events', 'total number screened; (3) drop-out rates; and (4) adherence to the rehabilitation programme', 'pain and disability scores', 'skin injury or pain', 'pain levels; (6) Patient-Specific Functional Scale; (7) the Shoulder Pain and Disability Index; and (8) pain self-efficacy']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0427048', 'cui_str': 'Movement of shoulder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0281980', 'cui_str': 'Injury of integument'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",28.0,0.2586,"Health-related quality of life was assessed using the Short-Form 12 and quality-adjusted life years (QALYs) were estimated.
","[{'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Ribeiro', 'Affiliation': 'School of Physiotherapy, University of Otago Division of Health Sciences, Dunedin, New Zealand daniel.ribeiro@otago.ac.nz.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Jafarian Tangrood', 'Affiliation': 'School of Physiotherapy, University of Otago Division of Health Sciences, Dunedin, New Zealand.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Department of Surgical Sciences, University of Otago Medical School, Dunedin, New Zealand.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sole', 'Affiliation': 'School of Physiotherapy, University of Otago Division of Health Sciences, Dunedin, New Zealand.'}, {'ForeName': 'J Haxby', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Department of Surgical Sciences, University of Otago Medical School, Dunedin, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2021-053572']
2148,35710228,"Physiotherapeutic approach in seamstresses with neck pain: A single-blind, randomized clinical trial.","PURPOSE


To investigate and compare the effects of therapeutic exercise, therapeutic ultrasound and photobiomodulation on pain, functionality and recruitment pattern of motor units, after a rehabilitation protocol for seamstresses with neck pain.
MATERIALS AND METHODS


All 36 female, randomly divided into three groups; i)exercise control group, ii)exercise and photobiomodulation group, iii)exercise and ultrasound group. The groups were composed of sewing machine operators with complaints neck pain. Clinical evaluations: Visual analog pain scale, questionnaires Nordic Musculoskeletal Questionnaire and the International Physical Activity Questionnaire, and electromyographic evaluations of the sternocleidomastoid and upper trapezius muscles. All variables were compared before and after the protocol. For statistical analysis, the values of mean, standard deviation and standard error of the mean were used. The values obtained were compared using the One-Way ANOVA with post-hoc Tukey, and Cohen's-d, with a significance coefficient of p < 0.05.
RESULTS


In the Ultrasound and laser groups there was a greater tendency to improve pain (p < 0.0001) and size of the effect on pain reduction (ultrasound = d:1.99; photobiomodulation = d:1.81). Between groups, there was a significant difference in post-treatment for the onset of right trapezius (p = 0.024) in the exercise and photobiomodulation groups (p = 0.0347). The photobiomodulation group showed pre and post-intervention differences in the left trapezius maximum onset (p = 0.010).
CONCLUSION


Interventions with photobiomodulation, ultrasound, and exercise assist to pain, function, and muscular activation in seamstresses with neck pain.",2022,In the Ultrasound and laser groups there was a greater tendency to improve pain (p < 0.0001) and size of the effect on pain reduction (ultrasound = d:1.99; photobiomodulation = d:1.81).,"['seamstresses with neck pain', 'All 36 female']","['i)exercise control group, ii)exercise and photobiomodulation group, iii)exercise and ultrasound group', 'therapeutic exercise, therapeutic ultrasound and photobiomodulation', 'Physiotherapeutic approach']","['left trapezius maximum onset', 'pain', 'onset of right trapezius', 'pain reduction', 'Clinical evaluations: Visual analog pain scale, questionnaires Nordic Musculoskeletal Questionnaire and the International Physical Activity Questionnaire, and electromyographic evaluations of the sternocleidomastoid and upper trapezius muscles']","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",,0.0184966,In the Ultrasound and laser groups there was a greater tendency to improve pain (p < 0.0001) and size of the effect on pain reduction (ultrasound = d:1.99; photobiomodulation = d:1.81).,"[{'ForeName': 'Morgana Martins', 'Initials': 'MM', 'LastName': 'De Toni', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences; Science, Technology and Health Center, Campus Araranguá, Universidade Federal de Santa Catarina, Araranguá, SC, Brazil; Laboratory of Assessment and Rehabilitation of Locomotor System (LARAL), Federal University of Santa Catarina, Araranguá, SC, Brazil.'}, {'ForeName': 'Rafael Silveira', 'Initials': 'RS', 'LastName': 'Duarte', 'Affiliation': 'Laboratory of Assessment and Rehabilitation of Locomotor System (LARAL), Federal University of Santa Catarina, Araranguá, SC, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Laboratory of Assessment and Rehabilitation of Locomotor System (LARAL), Federal University of Santa Catarina, Araranguá, SC, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Diefenthaeler', 'Affiliation': 'Professor at the Postgraduate Program in Rehabilitation Sciences; Science, Technology and Health Center, Campus Araranguá, Universidade Federal de Santa Catarina, Araranguá, SC, Brazil.'}, {'ForeName': 'Marisa de Cássia Registro', 'Initials': 'MCR', 'LastName': 'Fonseca', 'Affiliation': 'Professor at the Postgraduate Program in Rehabilitation and Functional Performance, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Rafael Inacio', 'Initials': 'RI', 'LastName': 'Barbosa', 'Affiliation': 'Laboratory of Assessment and Rehabilitation of Locomotor System (LARAL), Federal University of Santa Catarina, Araranguá, SC, Brazil; Professor at the Postgraduate Program in Rehabilitation Sciences; Science, Technology and Health Center, Campus Araranguá, Universidade Federal de Santa Catarina, Araranguá, SC, Brazil.'}, {'ForeName': 'Heloyse Uliam', 'Initials': 'HU', 'LastName': 'Kuriki', 'Affiliation': 'Laboratory of Assessment and Rehabilitation of Locomotor System (LARAL), Federal University of Santa Catarina, Araranguá, SC, Brazil; Professor at the Postgraduate Program in Rehabilitation Sciences; Science, Technology and Health Center, Campus Araranguá, Universidade Federal de Santa Catarina, Araranguá, SC, Brazil.'}, {'ForeName': 'Alexandre Márcio', 'Initials': 'AM', 'LastName': 'Marcolino', 'Affiliation': 'Laboratory of Assessment and Rehabilitation of Locomotor System (LARAL), Federal University of Santa Catarina, Araranguá, SC, Brazil; Professor at the Postgraduate Program in Rehabilitation Sciences; Science, Technology and Health Center, Campus Araranguá, Universidade Federal de Santa Catarina, Araranguá, SC, Brazil. Electronic address: alexandre.marcolino@ufsc.br.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2022.03.008']
2149,35710226,Detraining period of the PILATES method on functional capacity of elderly women with type 2 diabetes: A randomized clinical trial.,"INTRODUCTION


The aim of this study was to verify the effects of a 4-week detraining period on the functional capacity of elderly women with type-2 diabetes (T2D) after 12 weeks of a PILATES training program.
METHODS


Twenty-two individuals with T2D were randomly allocated into two groups: CONTROL (n = 11; 67.5 ± 6.3 years; 154.7 ± 6.1 cm; 73.5 ± 6.1 kg; calorie intake: 1487.5 ± 360.6 kcal/day) and PILATES (n = 11; 65.5 ± 5.5 years; 155.0 ± 4.5 cm; 66.2 ± 5.4 kg; calorie intake: 1289.3 ± 385.0 kcal/day). The PILATES group participated at a 12-week PILATES program at moderate intensity, 3x/week with each session lasting 60-min. The functional capacity was evaluated in the baseline (PRE), after 12-weeks (POST) and 4-week detraining period (4W_DT). The general index of functional capacity (GI FC ) was calculated for all participants.
RESULTS


In the PILATES group there was a reduction in performance (increased test time) for the GI FC  after 4W_DT in relation to POST (p < 0.05), however, GI FC  showing maintenance of performance gain in relation to the PRE (p > 0.05) (PRE: 36.0 ± 5.5 s vs. POST: 27.2 ± 4.0 s vs. 4W_DT: 29.0 ± 4.2 s). The CONTROL group had worse performance than the GI FC  POST (35.3 ± 4.6 s) and 4W_DT (35.4 ± 4.6 s) when compared to the PILATES group (F = 106.967; np2 = 0.842; p < 0.001).
CONCLUSION


A period of 4W_DT was not able to reduce the functional gains of elderly women with T2D after 12 weeks of PILATES training. These results have a practical application for training professionals, enabling better control and planning of training interruptions on the PILATES method for elderly women with T2D.",2022,"In the PILATES group there was a reduction in performance (increased test time) for the GI FC  after 4W_DT in relation to POST (p < 0.05), however, GI FC  showing maintenance of performance gain in relation to the PRE (p > 0.05)","['elderly women with type 2 diabetes', 'elderly women with type-2 diabetes (T2D) after 12 weeks of a PILATES training program', 'elderly women with T2D after 12 weeks of PILATES training', 'elderly women with T2D', 'Twenty-two individuals with T2D']",[],"['functional gains', 'general index of functional capacity (GI FC ', 'functional capacity', 'reduction in performance']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1720840', 'cui_str': 'Pilates Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",22.0,0.0180547,"In the PILATES group there was a reduction in performance (increased test time) for the GI FC  after 4W_DT in relation to POST (p < 0.05), however, GI FC  showing maintenance of performance gain in relation to the PRE (p > 0.05)","[{'ForeName': 'Karla Cinara Bezerra', 'Initials': 'KCB', 'LastName': 'Melo', 'Affiliation': 'College Uninassau Petrolina (UNINASSAU), PE, Petrolina, Brazil; Graduate Program on Physical Education (PPGEF), Federal University of Vale do São Francisco - UNIVASF, PE, Petrolina, Brazil; Programa de Educação Tutorial em Educação Física (PET/MEC-SESu), College of Physical Education, Federal University of Vale do São Francisco - UNIVASF, PE, Petrolina, Brazil.'}, {'ForeName': 'Geovani Alves Dos', 'Initials': 'GAD', 'LastName': 'Santos', 'Affiliation': 'College Uninassau Petrolina (UNINASSAU), PE, Petrolina, Brazil; Graduate Program on Physical Education (PPGEF), Federal University of Vale do São Francisco - UNIVASF, PE, Petrolina, Brazil.'}, {'ForeName': 'Flavio de Souza', 'Initials': 'FS', 'LastName': 'Araujo', 'Affiliation': 'Graduate Program on Health and Biological Sciences (PPGCSB), Federal University of Vale do São Francisco, Petrolina, Pernambuco, Brazil; Programa de Educação Tutorial em Educação Física (PET/MEC-SESu), College of Physical Education, Federal University of Vale do São Francisco - UNIVASF, PE, Petrolina, Brazil.'}, {'ForeName': 'Sergio Rodrigues', 'Initials': 'SR', 'LastName': 'Moreira', 'Affiliation': 'Graduate Program on Physical Education (PPGEF), Federal University of Vale do São Francisco - UNIVASF, PE, Petrolina, Brazil; Graduate Program on Health and Biological Sciences (PPGCSB), Federal University of Vale do São Francisco, Petrolina, Pernambuco, Brazil; Programa de Educação Tutorial em Educação Física (PET/MEC-SESu), College of Physical Education, Federal University of Vale do São Francisco - UNIVASF, PE, Petrolina, Brazil. Electronic address: sergio.moreira@univasf.edu.br.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2022.03.012']
2150,35710215,Comparative effectiveness of proprioceptive neuromuscular facilitation and passive vertebral mobilization for neck disability in patients with mechanical neck pain: A randomized controlled trial.,"OBJECTIVE


To compare the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) and Passive Vertebral Mobilization (PVM), both when given in adjunct to routine physical therapy (RPT), on neck disability in patients with mechanical neck pain (MNP).
METHODS


A single-blinded randomized controlled trial was conducted on 90 patients with MNP at the National Institute of Rehabilitation Medicine, Islamabad, Pakistan, from September 2015 to March 2018. The participants aged between 18 and 65 years were recruited through a simple random sampling technique and randomly divided into three groups i.e. PNF + RPT, PVM + RPT, and RPT. Each participant was evaluated pre and post-intervention (after four weeks) through neck disability index (NDI). The data were analyzed by using SPSS version 21.
RESULTS


The MANOVA was run on the pre-post mean differences of the variables to determine the changes within the groups which showed that the participants improved significantly in all the groups in terms of the NDI components and overall NDI score (p < 0.05). Univariate analysis with the post-hoc comparison and Tuckey HSD correction was used to determine the differences between the groups which showed that there was a significant difference between the interventional groups in the overall pain intensity, as well as pain experienced while performing personal care activities, reading, doing work, driving, sleeping, recreation and in the total NDI score (p < 0.05).
CONCLUSION


PVM (in adjunct to RPT) was more effective than PNF (in adjunct to RPT) for the patients with MNP to manage themselves in daily activities.
CLINICAL TRIAL REGISTRATION


NCT03813680 (at clinicaltrials.gov) (https://clinicaltrials.gov/ct2/show/NCT03813680).",2022,"CONCLUSION


PVM (in adjunct to RPT) was more effective than PNF (in adjunct to RPT) for the patients with MNP to manage themselves in daily activities.
","['patients with mechanical neck pain', 'participants aged between 18 and 65 years', '90 patients with MNP at the National Institute of Rehabilitation Medicine, Islamabad, Pakistan, from September 2015 to March 2018', 'patients with mechanical neck pain (MNP']","['PNF\xa0+\xa0RPT, PVM\xa0+\xa0RPT, and RPT', 'PNF', 'proprioceptive neuromuscular facilitation and passive vertebral mobilization', 'routine physical therapy (RPT', 'Proprioceptive Neuromuscular Facilitation (PNF) and Passive Vertebral Mobilization (PVM', 'PVM']","['neck disability index (NDI', 'NDI components and overall NDI score', 'pain experienced while performing personal care activities, reading, doing work, driving, sleeping, recreation and in the total NDI score', 'overall pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0562737', 'cui_str': 'Does perform personal care activity'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",90.0,0.112083,"CONCLUSION


PVM (in adjunct to RPT) was more effective than PNF (in adjunct to RPT) for the patients with MNP to manage themselves in daily activities.
","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ashfaq', 'Affiliation': 'Physiotherapy Department, National Institute of Rehabilitation Medicine, Islamabad, Pakistan.'}, {'ForeName': 'Muhammad Naveed', 'Initials': 'MN', 'LastName': 'Babur', 'Affiliation': 'Isra Institute of Rehabilitation Sciences, Isra University, Islamabad, Pakistan.'}, {'ForeName': 'Wardah Hussain', 'Initials': 'WH', 'LastName': 'Malick', 'Affiliation': 'Physiotherapy Department, National Institute of Rehabilitation Medicine, Islamabad, Pakistan.'}, {'ForeName': 'Mir Arif', 'Initials': 'MA', 'LastName': 'Hussain', 'Affiliation': 'Department of Rehabilitation Sciences, Shifa Tameer e Millat University, Islamabad, Pakistan. Electronic address: arif_dpt.ahs@stmu.edu.pk.'}, {'ForeName': 'Waqar Ahmed', 'Initials': 'WA', 'LastName': 'Awan', 'Affiliation': 'College of Rehabilitation and Allied Health Sciences, Riphah International University, Islamabad, Pakistan.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2022.02.009']
2151,35710213,The effects of pilates on posture and physical fitness parameters in 5-6 years old children: A non-randomized controlled study.,"BACKGROUND


Inactivity is a public health problem. Physical activity is beneficial at any age, but is even more critical in childhood for healthy development and growth.
OBJECTIVES


The purpose of this non-randomized controlled study was to investigate the effects of Pilates on posture and physical fitness parameters in 5-6 years old healthy children.
METHODS


Four preschool classes were divided into two groups. Five-six years old 66 preschool children were assigned to the Pilates (n = 31) and control (n = 35) groups. The Pilates group received a Pilates program twice a week for 10 weeks. The control group continued their daily routines. Postural assessment was evaluated using the New York Posture Rating Chart test and physical fitness was evaluated with the Eurofit test battery. Children were blinded to assignment. The Mann-Whitney U test was used for comparisons between groups, and the Wilcoxon Signed-Rank test was used for within-group comparisons.
RESULTS


In this study, within-group comparisons showed statistically significant improvements in the New York Posture Rating chart test (p < 0.001), Flamingo Balance, Sit and Reach, Standing Broad Jump, 30-Second Sit-Up, Bent Arm Hang, and 20-Meter Shuttle Run test scores (p < 0.05).
CONCLUSION


Pilates has positive effects on physical fitness parameters and postural evaluation in preschool children. This study suggests that Pilates can be an entertaining alternative physical activity in children aged 5-6 years.
CLINICALTRIALS



NUMBER


NCT05210426.",2022,"In this study, within-group comparisons showed statistically significant improvements in the New York Posture Rating chart test (p < 0.001), Flamingo Balance, Sit and Reach, Standing Broad Jump, 30-Second Sit-Up, Bent Arm Hang, and 20-Meter Shuttle Run test scores (p < 0.05).
","['5-6 years old children', 'preschool children', 'Four preschool classes', '5-6 years old healthy children', 'children aged 5-6 years', 'Five-six years old 66 preschool children']","['Pilates program', 'Pilates']","['Flamingo Balance, Sit and Reach, Standing Broad Jump, 30-Second Sit-Up, Bent Arm Hang, and 20-Meter Shuttle Run test scores', 'New York Posture Rating chart test', 'New York Posture Rating Chart test and physical fitness', 'posture and physical fitness parameters']","[{'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0325478', 'cui_str': 'Phoenicopteridae'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",66.0,0.0154622,"In this study, within-group comparisons showed statistically significant improvements in the New York Posture Rating chart test (p < 0.001), Flamingo Balance, Sit and Reach, Standing Broad Jump, 30-Second Sit-Up, Bent Arm Hang, and 20-Meter Shuttle Run test scores (p < 0.05).
","[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Ozturk', 'Affiliation': 'Aydin Adnan Menderes University, Soke Health Services Vocational School, Aydin, Turkey. Electronic address: nazan.ozturk@adu.edu.tr.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Unver', 'Affiliation': 'Pamukkale University, Physical Therapy and Rehabilitation Department, Denizli, Turkey.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2022.03.009']
2152,35710695,"Evaluation of the bioimpedance technique in newborns with a focus on electrode positioning: A prospective, randomized, crossover study.","BACKGROUND


Bioelectrical impedance analysis (BIA) is a good alternative for assessing total body water in newborns. However, the lack of standardization of the method for its use in the neonatal population raises doubts about its reliability and external validation.
OBJECTIVE


To compare resistance (R) and reactance (Xc) values measured by BIA with electrodes placed in the anatomical position and with electrodes placed at 5-cm intervals.
METHOD


Prospective, randomized, crossover study, in which R and Xc values were measured using monofrequency BIA. The choice of the first position of the electrodes to be analyzed in each NB was performed by a simple randomization, and subsequent measurements were performed in rapid succession. The calculated sample size was 203 evaluations. The paired t test was used to compare the means of R and Xc, and the Bland-Altman plot and linear regression were used to analyze how much the measured values were influenced by the electrode position.
RESULTS


Significant differences were found in the R (855.25 ± 147.79 vs 618.95 ± 93.28 Ω) and Xc (50.94 ± 17.34 vs 39.76 ± 18.35 Ω) values measured with electrodes in the anatomical position and at 5-cm intervals, respectively. The electrodes in the anatomical position produced R and Xc values 37.7% and 16.6%, respectively, higher on average when compared with 5-cm intervals.
CONCLUSIONS


The distance between the electrodes influences the measurement of R and Xc by BIA. These results highlight the importance of defining a standard for the placement of electrodes in newborns for the use of these measures in neonatal clinical practice.",2022,"RESULTS


Significant differences were found in the R (855.25 ± 147.79 vs 618.95 ± 93.28 Ω) and Xc (50.94 ± 17.34 vs 39.76 ± 18.35 Ω) values measured with electrodes in the anatomical position and at 5-cm intervals, respectively.","['newborns', 'newborns with a focus on electrode positioning']",['bioimpedance technique'],['resistance (R) and reactance (Xc) values'],"[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0150909,"RESULTS


Significant differences were found in the R (855.25 ± 147.79 vs 618.95 ± 93.28 Ω) and Xc (50.94 ± 17.34 vs 39.76 ± 18.35 Ω) values measured with electrodes in the anatomical position and at 5-cm intervals, respectively.","[{'ForeName': 'Luana F M', 'Initials': 'LFM', 'LastName': 'Toledo', 'Affiliation': 'Maternal and Child Department, Federal Fluminense University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Thatyana R', 'Initials': 'TR', 'LastName': 'Medeiros', 'Affiliation': 'Maternal and Child Department, Federal Fluminense University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Vieira', 'Affiliation': 'Maternal and Child Department, Federal Fluminense University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luis Guillermo', 'Initials': 'LG', 'LastName': 'Coca Velarde', 'Affiliation': 'Maternal and Child Department, Federal Fluminense University, Niterói, Rio de Janeiro, Brazil.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10879']
2153,35710688,Primary impact of simultaneous use of double devices through one-working channel when performing flexible ureteroscope with ureteral access sheath for single ureteral stone: In bench and retrospective clinical study.,"OBJECTIVES


This study aimed to compare the simultaneous use of two devices versus a single device through a single working channel in flexible ureteroscopy using a ureteral access sheath for single ureteral stones.
METHODS


In a bench study, the time to (i) set laser fiber, (ii) exchange laser fiber and nitinol basket through working channel, and (iii) pull out the device from working channel were measured 10 times in each step. In a clinical study, 156 patients who underwent flexible ureteroscopy with a ureteral access sheath for a ureteral stone in middle and upper ureter between April 2019 and November 2021 were assessed. One device was used at a time for 79 patients (S-Group) and two were simultaneously used for 77 (D-Group). Surgical outcomes and complications were compared.
RESULTS


In the bench study, the mean time to change from laser fiber to basket and from basket to laser fiber through the working channel were 26.1 ± 3.7 s and 23.6 ± 2.0 s (p = 0.084), respectively, which were significantly longer than the laser setup time (p < 0.001). In the clinical study, although the stone-free rate was not significantly different between the groups (S-Group 89.8%, D-Group 93.5%; p = 0.412), the median operation time was significantly shorter (p < 0.001) and the rate of postoperative stenting was significantly lower (p = 0.002) in the D-Group. There were no significant between-group differences in intra- and post-operative complications.
CONCLUSION


The simultaneous use of two devices through a single working channel is safe and could help save the time needed to exchange the laser fiber and nitinol basket.",2022,"In the clinical study, although the stone-free rate was not significantly different between the groups (S-Group 89.8%, D-Group 93.5%; p = 0.412), the median operation time was significantly shorter (p < 0.001) and the rate of postoperative stenting was significantly lower (p = 0.002) in the D-Group.","['for a ureteral stone in middle and upper ureter between April 2019 and November 2021 were assessed', '156 patients who underwent', 'single ureteral stone']","['flexible ureteroscopy with a ureteral access sheath', 'laser fiber, (ii) exchange laser fiber and nitinol basket through working channel, and (iii) pull out the device from working channel']","['intra- and post-operative complications', 'stone-free rate', 'median operation time', 'rate of postoperative stenting']","[{'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",156.0,0.0622288,"In the clinical study, although the stone-free rate was not significantly different between the groups (S-Group 89.8%, D-Group 93.5%; p = 0.412), the median operation time was significantly shorter (p < 0.001) and the rate of postoperative stenting was significantly lower (p = 0.002) in the D-Group.","[{'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Urology and Stone Center, Hara Genitourinary Hospital, Kobe City, Hyogo, Japan.'}, {'ForeName': 'Shuzo', 'Initials': 'S', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Urology, Medical School, Nagoya City University Graduate School of Medical Sciences, Nagoya, Aichi, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Department of Urology, Gyotoku General Hospital, Ichikawa, Chiba, Japan.'}, {'ForeName': 'Fukashi', 'Initials': 'F', 'LastName': 'Yamamichi', 'Affiliation': 'Department of Urology and Stone Center, Hara Genitourinary Hospital, Kobe City, Hyogo, Japan.'}, {'ForeName': 'Masaichiro', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Department of Urology and Stone Center, Hara Genitourinary Hospital, Kobe City, Hyogo, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Tominaga', 'Affiliation': 'Department of Urology and Stone Center, Hara Genitourinary Hospital, Kobe City, Hyogo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fujisawa', 'Affiliation': 'Division of Urology, Department of Surgery Related, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14957']
2154,35710669,Anthropomorphic Character Animations Versus Digital Chalk Talks in a Resident Diabetes Pharmacotherapy Curriculum: a Randomized Controlled Trial.,"BACKGROUND


Animation in medical education has boomed over the past two decades, and demand for distance learning technologies will likely continue in the context of the COVID-19 pandemic. However, experimental data guiding best practices for animation in medical education are scarce.
OBJECTIVE


To compare the efficacy of two animated video styles in a diabetes pharmacotherapy curriculum for internal medicine residents.
DESIGN


Learners were randomized to receive one of two versions of the same multimodal didactic curriculum. They received identical lectures, group activities, and quizzes, but were randomized to either digital chalk talk (DCT) videos or Sugar-Coated Science (SCS). SCS is an animated series using anthropomorphic characters, stories, and mnemonics to communicate knowledge.
PARTICIPANTS


Ninety-two internal medicine residents at a single academic medical center received the curriculum within ambulatory medicine didactics.
MAIN MEASURES


Knowledge was measured at multiple time points, as was residents' self-reported comfort using each medication class covered. Surveys assessed video acceptability and telepresence. Key themes were identified from open-ended feedback.
KEY RESULTS


Baseline knowledge was low, consistent with prior needs assessments. On immediate posttest, mean scores were higher with SCS than DCT (74.8% versus 68.4%), but the difference was not statistically significant, p = 0.10. Subgroup analyses revealed increased knowledge in the SCS group for specific medication classes. Delayed posttest showed significant knowledge gains averaging 17.6% across all participants (p < 0.05); these gains were similar between animation types. SCS achieved significantly higher telepresence, entertainment, and acceptability scores than DCT. Qualitative data suggested that residents prioritize well-designed, multimodal curricula over specific animation characteristics.
CONCLUSION


SCS and DCTs both led to learning within a multimodal curriculum, but SCS significantly enhanced learner experience. Animation techniques exemplified by both SCS and DCTs have roles in the medical educator toolkit. Selection between them should incorporate context, learner factors, and production resources.",2022,"On immediate posttest, mean scores were higher with SCS than DCT (74.8% versus 68.4%), but the difference was not statistically significant, p = 0.10.","['Learners', 'internal medicine residents', 'Ninety-two internal medicine residents at a single academic medical center received the curriculum within ambulatory medicine didactics']","['animated video styles', 'Anthropomorphic Character Animations Versus Digital Chalk Talks', 'SCS', 'digital chalk talk (DCT) videos or Sugar-Coated Science (SCS']","['video acceptability and telepresence', 'telepresence, entertainment, and acceptability scores', 'learner experience', 'knowledge gains']","[{'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0804304,"On immediate posttest, mean scores were higher with SCS than DCT (74.8% versus 68.4%), but the difference was not statistically significant, p = 0.10.","[{'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': ""Office of Medical Education, University of Hawai'i John A. Burns School of Medicine, Honolulu, HI, USA. bbrown3@hawaii.edu.""}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Gielissen', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Soares', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Gao', 'Affiliation': 'Division of Pulmonary & Critical Care, Northwestern Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Moeller', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Windish', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}]",Journal of general internal medicine,['10.1007/s11606-022-07510-8']
2155,35710599,"Liraglutide 3 mg on weight, body composition, and hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome: a randomized placebo-controlled-phase 3 study.","OBJECTIVE


To study the efficacy and safety of the GLP-1 analog liraglutide 3 mg (LIRA 3 mg) vs. placebo (PL) for reduction of body weight (BW) and hyperandrogenism in women with obesity and polycystic ovary syndrome (PCOS).
DESIGN


Randomized, double-blind, placebo-controlled trial.
SETTING


Hospital-based outpatient endocrine and metabolic center.
PATIENT(S)


Women diagnosed with PCOS (NIH criteria) were randomly assigned to LIRA 3 mg (n = 55) or PL (n = 27) once daily for 32 weeks with lifestyle intervention.
INTERVENTION(S)


Study visits at baseline and 32 weeks included BW and body composition by dual-energy x-ray absorptiometry. Oral glucose tolerance tests were done with sex steroids, free androgen index (FAI), and lipids measured in the fasting sample.
MAIN OUTCOME MEASURE(S)


The primary end points were changes in BW and FAI. Safety was assessed in all patients who received at least one dose of the study drug.
RESULT(S)


Change in BW from baseline to week 32 was -5.7% (±0.75) with LIRA 3 mg vs. -1.4% (±1.09) with PL. At week 32, more participants on LIRA 3 mg than on PL achieved at least 5% weight reductions (25 of 44 vs. 5 of 23). Free androgen index significantly reduced with LIRA 3 mg compared with the PL where the mean FAI slightly increased. Gastrointestinal events, which were mostly mild to moderate, were reported in 58.2% of the LIRA 3 mg-subjects and 18.5% of PL subjects.
CONCLUSION(S)


LIRA 3 mg once daily appears superior to PL in reducing BW and androgenicity and improving cardiometabolic parameters in women with PCOS and obesity.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03480022.",2022,Free androgen index significantly reduced with LIRA 3 mg compared with the PL where the mean FAI slightly increased.,"['women with obesity and polycystic ovary syndrome', 'patients who received at least one dose of the study drug', 'women with obesity and polycystic ovary syndrome (PCOS', 'Women diagnosed with PCOS (NIH criteria', 'Hospital-based outpatient endocrine and metabolic center', 'women with PCOS and obesity']","['Liraglutide', 'LIRA', 'GLP-1 analog liraglutide 3 mg (LIRA 3 mg) vs. placebo (PL', 'PL', 'placebo']","['free androgen index (FAI), and lipids measured in the fasting sample', 'Safety', 'body weight (BW) and hyperandrogenism', 'efficacy and safety', 'weight, body composition, and hormonal and metabolic parameters', 'mean FAI', 'Free androgen index', 'changes in BW and FAI', 'Oral glucose tolerance tests', 'BW and androgenicity and improving cardiometabolic parameters', 'Gastrointestinal events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenization syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.313188,Free androgen index significantly reduced with LIRA 3 mg compared with the PL where the mean FAI slightly increased.,"[{'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Elkind-Hirsch', 'Affiliation': ""Woman's Hospital Research Center, Baton Rouge, Louisiana; Woman's Endocrinology and Weight Management Clinic, Baton Rouge, Louisiana. Electronic address: karen.elkind-hirsch@womans.org.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Chappell', 'Affiliation': ""Fertility Answers, Woman's Hospital, Baton Rouge, Louisiana.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shaler', 'Affiliation': ""Woman's Hospital Research Center, Baton Rouge, Louisiana.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Storment', 'Affiliation': ""Fertility Answers, Woman's Hospital, Baton Rouge, Louisiana.""}, {'ForeName': 'Drake', 'Initials': 'D', 'LastName': 'Bellanger', 'Affiliation': ""Woman's Endocrinology and Weight Management Clinic, Baton Rouge, Louisiana.""}]",Fertility and sterility,['10.1016/j.fertnstert.2022.04.027']
2156,35710576,Prediction Aided Tapering In rheumatoid arthritis patients treated with biOlogicals (PATIO): protocol for a randomized controlled trial.,"BACKGROUND


Biological disease-modifying anti-rheumatic drugs (bDMARDs) are effective in the treatment of rheumatoid arthritis (RA) but are expensive and increase the risk of infection. Therefore, in patients with a stable low level of disease activity or remission, tapering bDMARDs should be considered. Although tapering does not seem to affect long-term disease control, (short-lived) flares are frequent during the tapering process. We have previously developed and externally validated a dynamic flare prediction model for use as a decision aid during stepwise tapering of bDMARDs to reduce the risk of a flare during this process.
METHODS


In this investigator-initiated, multicenter, open-label, randomized (1:1) controlled trial, we will assess the effect of incorporating flare risk predictions into a bDMARD tapering strategy. One hundred sixty RA patients treated with a bDMARD with stable low disease activity will be recruited. In the control group, the bDMARD will be tapered according to ""disease activity guided dose optimization"" (DGDO). In the intervention group, the bDMARD will be tapered according to a strategy that combines DGDO with the dynamic flare prediction model, where the next bDMARD tapering step is not taken in case of a high risk of flare. Patients will be randomized 1:1 to the control or intervention group. The primary outcome is the number of flares per patient (DAS28-CRP increase > 1.2, or DAS28-CRP increase > 0.6 with a current DAS28-CRP ≥ 2.9) during the 18-month follow-up period. Secondary outcomes include the number of patients with a major flare (flare duration ≥ 12 weeks), bDMARD dose reduction, adverse events, disease activity (DAS28-CRP) and patient-reported outcomes such as quality of life and functional disability. Health Care Utilization and Work Productivity will also be assessed.
DISCUSSION


This will be the first clinical trial to evaluate the benefit of applying a dynamic flare prediction model as a decision aid during bDMARD tapering. Reducing the risk of flaring during tapering may enhance the safety and (cost)effectiveness of bDMARD treatment. Furthermore, this study pioneers the field of implementing predictive algorithms in clinical practice.
TRIAL REGISTRATION


Dutch Trial Register number NL9798, registered 18 October 2021, https://www.trialregister.nl/trial/9798 . The study has received ethical review board approval (number NL74537.041.20).",2022,"We have previously developed and externally validated a dynamic flare prediction model for use as a decision aid during stepwise tapering of bDMARDs to reduce the risk of a flare during this process.
","['rheumatoid arthritis patients treated with', 'One hundred sixty RA patients treated with a bDMARD with stable low disease activity will be recruited']",['biOlogicals (PATIO'],"['number of flares per patient (DAS28-CRP increase\u2009>\u20091.2, or DAS28-CRP', 'number of patients with a major flare (flare duration\u2009≥\u200912\xa0weeks), bDMARD dose reduction, adverse events, disease activity (DAS28-CRP) and patient-reported outcomes such as quality of life and functional disability']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",160.0,0.132489,"We have previously developed and externally validated a dynamic flare prediction model for use as a decision aid during stepwise tapering of bDMARDs to reduce the risk of a flare during this process.
","[{'ForeName': 'Marianne A', 'Initials': 'MA', 'LastName': 'Messelink', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3508, GA, Utrecht, The Netherlands. M.A.Messelink@umcutrecht.nl.'}, {'ForeName': 'Matthijs S', 'Initials': 'MS', 'LastName': 'van der Leeuw', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Alfons A', 'Initials': 'AA', 'LastName': 'den Broeder', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574, NA, Ubbergen, The Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Tekstra', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Marlies C', 'Initials': 'MC', 'LastName': 'van der Goes', 'Affiliation': 'Department of Rheumatology, Meander Medical Center, Maatweg 3, 3813, TZ, Amersfoort, The Netherlands.'}, {'ForeName': 'Marloes W', 'Initials': 'MW', 'LastName': 'Heijstek', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Lafeber', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Paco M J', 'Initials': 'PMJ', 'LastName': 'Welsing', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3508, GA, Utrecht, The Netherlands.'}]",Trials,['10.1186/s13063-022-06471-x']
2157,35710572,"Evaluation of the safety and immunogenicity of different COVID-19 vaccine combinations in healthy individuals: study protocol for a randomized, subject-blinded, controlled phase 3 trial [PRIBIVAC].","BACKGROUND


Over 2021, COVID-19 vaccination programs worldwide focused on raising population immunity through the primary COVID-19 vaccine series. In Singapore, two mRNA vaccines (BNT162b2 and mRNA-1273) and the inactivated vaccine CoronaVac are currently authorized under the National Vaccination Programme for use as the primary vaccination series. More than 90% of the Singapore population has received at least one dose of a COVID-19 vaccine as of December 2021. With the demonstration that vaccine effectiveness wanes in the months after vaccination, and the emergence of Omicron which evades host immunity from prior infection and/or vaccination, attention in many countries has shifted to how best to maintain immunity through booster vaccinations.
METHODS


The objectives of this phase 3, randomized, subject-blinded, controlled clinical trial are to assess the safety and immunogenicity of heterologous boost COVID-19 vaccine regimens (intervention groups 1-4) compared with a homologous boost regimen (control arm) in up to 600 adult volunteers. As non-mRNA vaccine candidates may enter the study at different time points depending on vaccine availability and local regulatory approval, participants will be randomized at equal probability to the available intervention arms at the time of randomization. Eligible participants will have received two doses of a homologous mRNA vaccine series with BNT162b2 or mRNA-1273 at least 6 months prior to enrolment. Participants will be excluded if they have a history of confirmed SARS or SARS-CoV-2 infection, are immunocompromised, or are pregnant. Participants will be monitored for adverse events and serious adverse events by physical examinations, laboratory tests and self-reporting. Blood samples will be collected at serial time points [pre-vaccination/screening (day - 14 to day 0), day 7, day 28, day 180, day 360 post-vaccination] for assessment of antibody and cellular immune parameters. Primary endpoint is the level of anti-SARS-CoV-2 spike immunoglobulins at day 28 post-booster and will be measured against wildtype SARS-CoV-2 and variants of concern. Comprehensive immune profiling of the humoral and cellular immune response to vaccination will be performed.
DISCUSSION


This study will provide necessary data to understand the quantity, quality, and persistence of the immune response to a homologous and heterologous third booster dose of COVID-19 vaccines. This is an important step in developing COVID-19 vaccination programs beyond the primary series.
TRIAL REGISTRATION


ClinicalTrials.gov NCT05142319 . Registered on 2 Dec 2021.",2022,Primary endpoint is the level of anti-SARS-CoV-2 spike immunoglobulins at day 28 post-booster and will be measured against wildtype SARS-CoV-2 and variants of concern.,"['healthy individuals', '600 adult volunteers']","['COVID-19 vaccine combinations', 'COVID-19 vaccine', 'homologous mRNA vaccine series with BNT162b2 or mRNA-1273', 'heterologous boost COVID-19 vaccine']","['safety and immunogenicity', 'adverse events and serious adverse events by physical examinations, laboratory tests and self-reporting', 'wildtype SARS-CoV-2 and variants of concern', 'level of anti-SARS-CoV-2 spike immunoglobulins']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0206253', 'cui_str': 'Vaccines, Combination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0439860', 'cui_str': 'Heterologous'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}]",600.0,0.419054,Primary endpoint is the level of anti-SARS-CoV-2 spike immunoglobulins at day 28 post-booster and will be measured against wildtype SARS-CoV-2 and variants of concern.,"[{'ForeName': 'Xuan Ying', 'Initials': 'XY', 'LastName': 'Poh', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'I Russel', 'Initials': 'IR', 'LastName': 'Lee', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Lim', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'Jefanie', 'Initials': 'J', 'LastName': 'Teo', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'Po Ying', 'Initials': 'PY', 'LastName': 'Chia', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'Sean W X', 'Initials': 'SWX', 'LastName': 'Ong', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'Tau Hong', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'Ray J H', 'Initials': 'RJH', 'LastName': 'Lin', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'Lisa F P', 'Initials': 'LFP', 'LastName': 'Ng', 'Affiliation': 'A*STAR Infectious Diseases Lab, Singapore, Singapore.'}, {'ForeName': 'Ee Chee', 'Initials': 'EC', 'LastName': 'Ren', 'Affiliation': 'Singapore Immunology Network, A*STAR, Singapore, Singapore.'}, {'ForeName': 'Raymond T P', 'Initials': 'RTP', 'LastName': 'Lin', 'Affiliation': 'National Public Health Laboratory, Singapore, Singapore.'}, {'ForeName': 'Lin-Fa', 'Initials': 'LF', 'LastName': 'Wang', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Renia', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore.'}, {'ForeName': 'Barnaby E', 'Initials': 'BE', 'LastName': 'Young', 'Affiliation': 'National Centre for Infectious Diseases, Singapore, Singapore. barnaby_young@ncid.sg.'}]",Trials,['10.1186/s13063-022-06345-2']
2158,35710571,Partial randomized benchmarking.,"In randomized benchmarking of quantum logical gates, partial twirling can be used for simpler implementation, better scaling, and higher accuracy and reliability. For instance, for two-qubit gates, single-qubit twirling is easier to realize than full averaging. We analyze such simplified, partial twirling and demonstrate that, unlike for the standard randomized benchmarking, the measured decay of fidelity is a linear combination of exponentials with different decay rates (3 for two qubits and single-bit twirling). The evolution with the sequence length is governed by an iteration matrix, whose spectrum gives the decay rates. For generic two-qubit gates one slowest exponential dominates and characterizes gate errors in three channels. Its decay rate is close, but different from that in the standard randomized benchmarking, and we find the leading correction. Using relations to the local invariants of two-qubit gates we identify all exceptional gates with several slow exponentials and analyze possibilities to extract their decay rates from the measured curves.",2022,"In randomized benchmarking of quantum logical gates, partial twirling can be used for simpler implementation, better scaling, and higher accuracy and reliability.",[],[],[],[],[],[],3.0,0.110524,"In randomized benchmarking of quantum logical gates, partial twirling can be used for simpler implementation, better scaling, and higher accuracy and reliability.","[{'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Dubovitskii', 'Affiliation': 'Moscow Institute of Physics and Technology, Dolgoprudny, Russia.'}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Makhlin', 'Affiliation': 'Condensed-Matter Physics Laboratory, HSE University, Moscow, Russia. makhlin@itp.ac.ru.'}]",Scientific reports,['10.1038/s41598-022-13813-x']
2159,35710560,"Fluconazole in hypercalciuric patients with increased 1,25(OH) 2 D levels: the prospective, randomized, placebo-controlled, double-blind FLUCOLITH trial.","BACKGROUND


Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis possibly leading to chronic kidney disease (CKD) and bone complications in adults. Orphan diseases with different underlying primary pathophysiology share inappropriately increased 1,25(OH) 2 D levels and hypercalciuria, e.g., hypersensitivity to vitamin D and renal phosphate wasting. Their management is challenging, typically based on hyperhydration and dietary advice. The antifungal azoles are known to inhibit the 1α-hydroxylase and therefore decrease 1,25(OH) 2 D levels; they are commonly used, with well described pharmacokinetic and tolerability data. Fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 or SLC34A3 mutations, with no safety warnings. Thus, based on these case reports, we hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH) 2 D levels.
METHODS


The FLUCOLITH trial is a prospective, interventional, randomized in parallel groups (1:1), placebo-controlled, double-blind trial. A total of 60 patients (10-60 years) with nephrolithiasis and/or nephrocalcinosis history, hypercalciuria (> 0.1 mmol/kg/day), increased 1,25(OH) 2 D levels (> 150 pmol/L), and 25-OH-D levels >20 nmol/L will be included. Inclusions will be performed only from mid-September to the beginning of February to avoid bias due to sunlight-induced vitamin D synthesis. The primary endpoint will be the proportion of patients with normalization of 24-h calciuria between baseline and 16 weeks, or with a relative decrease of at least 30% of 24-h calciuria in patients who still display at W16 a 24-h hypercalciuria.
DISCUSSION


The current challenge is to propose an efficient treatment to patients with hypercalciuria and increased 1,25(OH) 2 D levels in order to prevent later complications and notably CKD that can ultimately lead to end-stage renal disease. Based on improvement of knowledge in phosphate/calcium metabolism, pathophysiology and genetics, the ""off-label"" use of fluconazole was recently reported to be useful in hypercalciuric patients with increased 1,25(OH) 2 D levels. Thus, the FLUCOLITH study is a unique opportunity to develop a new indication of a well-known and not expensive drug in orphan renal diseases, the ultimate objective being the secondary prevention of CKD worsening in these patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04495608 . Registered on July 23, 2020.",2022,"Fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 or SLC34A3 mutations, with no safety warnings.","['patients with hypercalciuria and increased 1,25(OH) 2 D levels', 'hypercalciuric patients with increased 1,25(OH) 2 D levels', 'patients with CYP24A1 or SLC34A3 mutations', '60 patients (10-60 years) with nephrolithiasis and/or nephrocalcinosis history, hypercalciuria (> 0.1 mmol/kg/day), increased 1,25(OH) 2 D levels (> 150 pmol/L), and 25-OH-D levels >20 nmol/L will be included']","['placebo', 'Fluconazole', 'fluconazole']",['proportion of patients with normalization of 24-h calciuria'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020438', 'cui_str': 'Hypercalciuria'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0283470', 'cui_str': '1 alpha,25-Dihydroxycholecalciferol-24-Hydroxylase'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0027709', 'cui_str': 'Nephrocalcinosis'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1532977', 'cui_str': 'mmol/kg/day'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439284', 'cui_str': 'pmol/L'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}]",60.0,0.119592,"Fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 or SLC34A3 mutations, with no safety warnings.","[{'ForeName': 'Aurélia', 'Initials': 'A', 'LastName': 'Bertholet-Thomas', 'Affiliation': 'Centre de Référence des Maladies Rénales Rares, filières maladies rares ORKID and ERK-Net, Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques, Hôpital Femme Mère Enfant, Boulevard Pinel, 69677, Bron, Cedex, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Portefaix', 'Affiliation': ""Centre d'Investigation Clinique, Hôpital Cardiovasculaire Louis Pradel, Inserm 1407, 69500, Bron, France.""}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Flammier', 'Affiliation': 'Centre de Référence des Maladies Rénales Rares, filières maladies rares ORKID and ERK-Net, Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques, Hôpital Femme Mère Enfant, Boulevard Pinel, 69677, Bron, Cedex, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Dhelens', 'Affiliation': 'Pharmacie, FRIPHARM, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Subtil', 'Affiliation': 'Service de Biostatistique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Dubourg', 'Affiliation': 'Néphrologie, Dialyse, Hypertension Artérielle et Exploration Fonctionnelle Rénale, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Laudy', 'Affiliation': ""Centre d'Investigation Clinique, Hôpital Cardiovasculaire Louis Pradel, Inserm 1407, 69500, Bron, France.""}, {'ForeName': 'Myrtille', 'Initials': 'M', 'LastName': 'Le Bouar', 'Affiliation': ""Centre d'Investigation Clinique, Hôpital Cardiovasculaire Louis Pradel, Inserm 1407, 69500, Bron, France.""}, {'ForeName': 'Inesse', 'Initials': 'I', 'LastName': 'Boussaha', 'Affiliation': ""Centre d'Investigation Clinique, Hôpital Cardiovasculaire Louis Pradel, Inserm 1407, 69500, Bron, France.""}, {'ForeName': 'Marietou', 'Initials': 'M', 'LastName': 'Ndiaye', 'Affiliation': ""Centre d'Investigation Clinique, Hôpital Cardiovasculaire Louis Pradel, Inserm 1407, 69500, Bron, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Molin', 'Affiliation': 'Service de Génétique, CHU de Caen, Caen, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lemoine', 'Affiliation': 'Centre de Référence des Maladies Rénales Rares, filières maladies rares ORKID and ERK-Net, Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques, Hôpital Femme Mère Enfant, Boulevard Pinel, 69677, Bron, Cedex, France.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Bacchetta', 'Affiliation': 'Centre de Référence des Maladies Rénales Rares, filières maladies rares ORKID and ERK-Net, Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques, Hôpital Femme Mère Enfant, Boulevard Pinel, 69677, Bron, Cedex, France. Justine.bacchetta@chu-lyon.fr.'}]",Trials,['10.1186/s13063-022-06302-z']
2160,35710539,Short-term effect of deprescribing antihypertensives in older people.,"Commentary on:  Sheppard JP, Burt J, Lown M,  et al  Effect of antihypertensive medication reduction vs usual care on short-term blood pressure control in patients with hypertension aged 80 years and older: The OPTIMISE randomized clinical trial.  JAMA  2020;323:2039-51.",2022,"Commentary on:  Sheppard JP, Burt J, Lown M,  et al  Effect of antihypertensive medication reduction vs usual care on short-term blood pressure control in patients with hypertension aged 80 years and older:","['patients with hypertension aged 80 years and older', 'older people']",['deprescribing antihypertensives'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}]",[],,0.0825876,"Commentary on:  Sheppard JP, Burt J, Lown M,  et al  Effect of antihypertensive medication reduction vs usual care on short-term blood pressure control in patients with hypertension aged 80 years and older:","[{'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Morselli', 'Affiliation': ""King's College, London, UK.""}, {'ForeName': 'Teck K', 'Initials': 'TK', 'LastName': 'Khong', 'Affiliation': ""Clinical Pharmacology, St George's University of London, London, UK tkhong@sgul.ac.uk.""}]",Drug and therapeutics bulletin,['10.1136/dtb.2022.000030']
2161,35710520,Development and evaluation of a remote training strategy for the implementation of mental health evidence-based practices in rural schools: pilot study protocol.,"BACKGROUND


An increasing number of schools in rural settings are implementing multi-tier positive behavioral interventions and supports (PBIS) to address school-climate problems. PBIS can be used to provide the framework for the implementation of evidence-based practices (EBPs) to address children's mental health concerns. Given the large service disparities for children in rural areas, offering EBPs through PBIS can improve access and lead to better long-term outcomes. A key challenge is that school personnel need technical assistance in order to implement EBPs with fidelity and clinical effectiveness. Providing ongoing on-site support is not feasible or sustainable in the majority of rural schools, due to their remote physical location. For this reason, remote training technology has been recommended for providing technical assistance to behavioral health staff (BHS) in under-served rural communities.
OBJECTIVES


The purpose of this study is to use the user-centered design, guided by an iterative process (rapid prototyping), to develop and evaluate the appropriateness, feasibility, acceptability, usability, and preliminary student outcomes of two online training strategies for the implementation of EBPs at PBIS Tier 2.
METHODS


The study will employ a pragmatic design comprised of a mixed-methods approach for the development of the training platform, and a hybrid type 2, pilot randomized controlled trial to examine the implementation and student outcomes of two training strategies: Remote Video vs. Remote Video plus Coaching.
DISCUSSION


There is a clear need for well-designed remote training studies focused on training in non-traditional settings. Given the lack of well-trained mental health professionals in rural settings and the stark disparities in access to services, the development and pilot-testing of a remote training strategy for BHS in under-served rural schools could have a significant public health impact.
ETHICS AND DISSEMINATION


The project was reviewed and approved by the institutional review board. Results will be submitted to ClinicalTrials.gov and disseminated to community partners and participants, peer-reviewed journals, and academic conferences.
TRIAL REGISTRATION


ClinicialTrials.gov, NCT05034198 and NCT05039164.",2022,"Providing ongoing on-site support is not feasible or sustainable in the majority of rural schools, due to their remote physical location.",['mental health evidence-based practices in rural schools'],['two training strategies: Remote Video vs. Remote Video plus Coaching'],[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.0387203,"Providing ongoing on-site support is not feasible or sustainable in the majority of rural schools, due to their remote physical location.","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Eiraldi', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, 2716 South Street, Room 8293, Philadelphia, PA, 19146-2305, USA. eiraldi@upenn.edu.""}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'McCurdy', 'Affiliation': 'School of Professional and Applied Psychology, Philadelphia College of Osteopathic Medicine, Philadelphia, USA.'}, {'ForeName': 'Muniya S', 'Initials': 'MS', 'LastName': 'Khanna', 'Affiliation': 'OCD and Anxiety Institute, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Goldstein', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, 2716 South Street, Room 8293, Philadelphia, PA, 19146-2305, USA.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Comly', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, 2716 South Street, Room 8293, Philadelphia, PA, 19146-2305, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Francisco', 'Affiliation': 'Devereux Center for Effective Schools, King of Prussia, PA, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Rutherford', 'Affiliation': 'Devereux Center for Effective Schools, King of Prussia, PA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Wilson', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, 2716 South Street, Room 8293, Philadelphia, PA, 19146-2305, USA.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Henson', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, 2716 South Street, Room 8293, Philadelphia, PA, 19146-2305, USA.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Farmer', 'Affiliation': 'School of Education, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Abbas F', 'Initials': 'AF', 'LastName': 'Jawad', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, 2716 South Street, Room 8293, Philadelphia, PA, 19146-2305, USA.""}]",Pilot and feasibility studies,['10.1186/s40814-022-01082-4']
2162,35710510,Effectiveness of isometric exercises on disability and pain of cervical spondylosis: a randomized controlled trial.,"BACKGROUND


Neck pain and disability is a significant public health problem with only very few evidence-based treatment option. The aim of this study was to evaluate the effect of isometric exercise on pain and disability of cervical spondylosis.
METHODS


Twenty four patients with cervical osteoarthritis and neck pain (22 females and 2 males; mean age, 46.70 ± 13.71 years) were recruited and randomly allocated into 2 arms: neck isometric exercises (n = 12) and conservative management without exercise (n = 12). The Neck Disability Index (NDI) and Neck Pain and Disability Scale (NPAD) were used to assess participants at baseline and after 4 weeks.
RESULTS


Basic characteristics, NDI score and NPAD score were not significantly different between groups at baseline. The exercise arm demonstrated significantly lower scores regarding NDI (mean, 17.41 vs. 25.58; P-value = 0.035) and NPAD (mean, 25.33 vs. 66.67; P < 0.001), compared to the control arm after 4 weeks. The exercise arm also showed significant within group reduction considering NDI and NPAD scores after 4 weeks (Both, P < 0.001).
CONCLUSION


Our findings suggested that isometric exercises might be a beneficial treatment for improving pain and disability caused by cervical spondylosis. Trial registration This study was registered at irct.ir (Iranian Registry of Clinical Trials) with the code IRCT20220206053950N1, 07.05.2022, retrospectively registered.",2022,"The exercise arm demonstrated significantly lower scores regarding NDI (mean, 17.41 vs. 25.58; P-value = 0.035) and NPAD (mean, 25.33 vs. 66.67; P < 0.001), compared to the control arm after 4 weeks.","['Twenty four patients with cervical osteoarthritis and neck pain (22 females and 2 males; mean age, 46.70\u2009±\u200913.71\xa0years']","['neck isometric exercises (n\u2009=\u200912) and conservative management without exercise', 'isometric exercise', 'isometric exercises']","['Neck Disability Index (NDI) and Neck Pain and Disability Scale (NPAD', 'NDI and NPAD scores', 'pain and disability', 'pain and disability of cervical spondylosis', 'scores regarding NDI', 'disability and pain of cervical spondylosis', 'NPAD', 'Basic characteristics, NDI score and NPAD score']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263854', 'cui_str': 'Cervical arthritis'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}]",24.0,0.110255,"The exercise arm demonstrated significantly lower scores regarding NDI (mean, 17.41 vs. 25.58; P-value = 0.035) and NPAD (mean, 25.33 vs. 66.67; P < 0.001), compared to the control arm after 4 weeks.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Internal Medicine, Vali-E-Asr Hospital, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Sahand', 'Initials': 'S', 'LastName': 'Ameri', 'Affiliation': 'Department of Internal Medicine, Vali-E-Asr Hospital, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Karimi Moghaddam', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Vali-E-Asr Hospital, Zanjan University of Medical sciences, Zanjan, Iran.'}, {'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Karimi Moghaddam', 'Affiliation': 'Department of Radiation Oncology, Vali-E-Asr Hospital, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zeraatchi', 'Affiliation': 'Department of Emergency Medicine, Valiasr-E-Asr Hospital, Ayatollah Mousavi Hospital, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran. zeraatchi.zums@gmail.com.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-022-00500-7']
2163,35710491,Implementation strategy in collaboration with people with lived experience of mental illness to reduce stigma among primary care providers in Nepal (RESHAPE): protocol for a type 3 hybrid implementation effectiveness cluster randomized controlled trial.,"BACKGROUND


There are increasing efforts for the integration of mental health services into primary care settings in low- and middle-income countries. However, commonly used approaches to train primary care providers (PCPs) may not achieve the expected outcomes for improved service delivery, as evidenced by low detection rates of mental illnesses after training. One contributor to this shortcoming is the stigma among PCPs. Implementation strategies for training PCPs that reduce stigma have the potential to improve the quality of services.
DESIGN


In Nepal, a type 3 hybrid implementation-effectiveness cluster randomized controlled trial will evaluate the implementation-as-usual training for PCPs compared to an alternative implementation strategy to train PCPs, entitled Reducing Stigma among Healthcare Providers (RESHAPE). In implementation-as-usual, PCPs are trained on the World Health Organization Mental Health Gap Action Program Intervention Guide (mhGAP-IG) with trainings conducted by mental health specialists. In RESHAPE, mhGAP-IG training includes the added component of facilitation by people with lived experience of mental illness (PWLE) and their caregivers using PhotoVoice, as well as aspirational figures. The duration of PCP training is the same in both arms. Co-primary outcomes of the study are stigma among PCPs, as measured with the Social Distance Scale at 6 months post-training, and reach, a domain from the RE-AIM implementation science framework. Reach is operationalized as the accuracy of detection of mental illness in primary care facilities and will be determined by psychiatrists at 3 months after PCPs diagnose the patients. Stigma will be evaluated as a mediator of reach. Cost-effectiveness and other RE-AIM outcomes will be assessed. Twenty-four municipalities, the unit of clustering, will be randomized to either mhGAP-IG implementation-as-usual or RESHAPE arms, with approximately 76 health facilities and 216 PCPs divided equally between arms. An estimated 1100 patients will be enrolled for the evaluation of accurate diagnosis of depression, generalized anxiety disorder, psychosis, or alcohol use disorder. Masking will include PCPs, patients, and psychiatrists.
DISCUSSION


This study will advance the knowledge of stigma reduction for training PCPs in partnership with PWLE. This collaborative approach to training has the potential to improve diagnostic competencies. If successful, this implementation strategy could be scaled up throughout low-resource settings to reduce the global treatment gap for mental illness.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04282915 . Date of registration: February 25, 2020.",2022,"Co-primary outcomes of the study are stigma among PCPs, as measured with the Social Distance Scale at 6 months post-training, and reach, a domain from the RE-AIM implementation science framework.","['1100 patients will be enrolled for the evaluation of accurate diagnosis of depression, generalized anxiety\xa0disorder, psychosis, or alcohol use disorder', 'collaboration with people with lived experience of mental illness to reduce stigma among primary care providers in Nepal (RESHAPE']","['RESHAPE, mhGAP-IG training', 'mhGAP-IG implementation-as-usual or RESHAPE']","['Cost-effectiveness', 'duration of PCP training', 'Social Distance Scale']","[{'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1100.0,0.0209738,"Co-primary outcomes of the study are stigma among PCPs, as measured with the Social Distance Scale at 6 months post-training, and reach, a domain from the RE-AIM implementation science framework.","[{'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Division of Global Mental Health, Department of Psychiatry, George Washington University, Washington D.C., USA. bkohrt@gwu.edu.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Dristy', 'Initials': 'D', 'LastName': 'Gurung', 'Affiliation': 'Transcultural Psychosocial Organization Nepal (TPO Nepal), Pokhara, Nepal.'}, {'ForeName': 'Xueqi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Neupane', 'Affiliation': 'Transcultural Psychosocial Organization Nepal (TPO Nepal), Pokhara, Nepal.'}, {'ForeName': 'Nagendra P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': 'Transcultural Psychosocial Organization Nepal (TPO Nepal), Kathmandu, Nepal.'}, {'ForeName': 'Muralikrishnan R', 'Initials': 'MR', 'LastName': 'Kartha', 'Affiliation': ""King's Health Economics, IOPPN, King's College London, London, UK.""}, {'ForeName': 'Anubhuti', 'Initials': 'A', 'LastName': 'Poudyal', 'Affiliation': 'Department of Sociomedical Sciences, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ritika', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Division of Global Mental Health, Department of Psychiatry, George Washington University, Washington, D.C., 20036, USA.'}, {'ForeName': 'Sauharda', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': 'Jackson School of International Studies and Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Phanindra Prasad', 'Initials': 'PP', 'LastName': 'Baral', 'Affiliation': 'Non-communicable Disease and Mental Health Section, Epidemiology and Disease Control Division (EDCD), Department of Health Services (DoHS), Ministry of Health and Population (MoHP), Kathmandu, Nepal.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'McCutchan', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Petra C', 'Initials': 'PC', 'LastName': 'Gronholm', 'Affiliation': ""Centre for Global Mental Health and Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lempp', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""Centre for Global Mental Health and Centre for Implementation Science, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Gautam', 'Affiliation': 'Transcultural Psychosocial Organization Nepal (TPO Nepal), Kathmandu, Nepal.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, Center for Global Mental Health, King's College London, London, UK.""}]",Implementation science : IS,['10.1186/s13012-022-01202-x']
2164,35710481,Germline Polymorphisms in Genes Involved in the Antioxidant System Predict the Efficacy of Cetuximab in Metastatic Colorectal Cancer Patients Enrolled in FIRE-3 Trial.,"BACKGROUND


Reactive oxygen species activate EGFR/RAS/MAPK signaling either through the inactivation of phosphatases or by direct oxidation of kinases. We hypothesized that functional single-nucleotide polymorphisms (SNPs) in antioxidant genes link to the efficacy of cetuximab in patients with metastatic colorectal cancer (mCRC).
PATIENTS AND METHODS


We analyzed genomic and clinical data from FIRE-3, a phase III trial comparing cetuximab and bevacizumab along with FOLFIRI in untreated mCRC patients. Genomic DNA extracted from blood samples was genotyped. Thirteen functional SNPs in antioxidant genes were tested for associations with clinical outcomes.
RESULTS


In total, 236 patients were included (FOLFIRI/cetuximab arm, n = 129; FOLFIRI/bevacizumab arm, n = 107). In univariate analysis, two SNPs (TXN2 rs4821494 and GPX4 rs4807542) were significantly associated with overall survival (OS) in the FOLFIRI/cetuximab arm. Multivariate analysis confirmed the significant association of TXN2 rs4821494 (T/T vs. any G allele, hazard ratio = 2.47, 95% confidence interval = 1.06-5.72, P = .03). In the FOLFIRI/bevacizumab arm, no SNPs were significantly associated with clinical outcomes. Treatment-by-SNP interaction test confirmed the predictive value of TXN2 rs4821494 (OS: P = .03).
CONCLUSION


TXN2 rs4821494 involved in the antioxidant system may predict the efficacy of cetuximab-based first-line chemotherapy in mCRC, warranting further validation studies.",2022,"Multivariate analysis confirmed the significant association of TXN2 rs4821494 (T/T vs. any G allele, hazard ratio = ","['untreated mCRC patients', 'patients with metastatic colorectal cancer (mCRC', '236 patients were included (FOLFIRI/cetuximab arm, n\xa0', 'Metastatic Colorectal Cancer Patients']","['cetuximab and bevacizumab', 'bevacizumab', 'FOLFIRI/bevacizumab', 'cetuximab', 'Cetuximab']",['overall survival (OS'],"[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",236.0,0.275945,"Multivariate analysis confirmed the significant association of TXN2 rs4821494 (T/T vs. any G allele, hazard ratio = ","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Millstein', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Medical Department, Division of Oncology and Hematology, Charité Universitaetsmedizin Berlin, Germany.'}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Battaglin', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Natsuko', 'Initials': 'N', 'LastName': 'Kawanishi', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Jayachandran', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Soni', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA. Electronic address: lenz@usc.edu.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2022.05.005']
2165,35710473,Learning from errors? The impact of erroneous example elaboration on learning outcomes of medical statistics in Chinese medical students.,"BACKGROUND


Constructivism theory has suggested that constructing students' own meaning is essential to successful learning. The erroneous example can easily trigger learners' confusion and metacognition, which may ""force"" students to process the learning material and construct meaning deeply. However, some learners exhibit a low level of elaboration activity and spend little time on each example. Providing instructional scaffolding and elaboration training may be an efficient method for addressing this issue. The current study conducted a randomized controlled trial to examine the effectiveness of erroneous example elaboration training on learning outcomes and the mediating effects of metacognitive load for Chinese students in medical statistics during the COVID-19 pandemic.
METHODS


Ninety-one third-year undergraduate medical students were randomly assigned to the training group (n = 47) and the control group (n = 44). Prerequisite course performance and learning motivation were collected as covariates. The mid-term exam and final exam were viewed as posttest and delayed-test to make sure the robustness of the training effect. The metacognitive load was measured as a mediating variable to explain the relationship between the training and academic performance.
RESULTS


The training significantly improved both posttest and delayed-test performance compared with no training (F posttest  = 26.65, p < 0.001, Partial η 2  = 0.23; F delayed test  = 38.03, p < 0.001, Partial η 2  = 0.30). The variation trend in metacognitive load in the two groups was significantly different (F = 2.24, p < 0.05, partial η 2  = 0.20), but metacognitive load could not explain the positive association between the treatment and academic performance (β = - 0.06, se = 0.24, 95% CI - 0.57 to 0.43).
CONCLUSIONS


Erroneous example learning and metacognitive demonstrations are effective for academic performance in the domain of medical statistics, but their underlying mechanism merits further study.",2022,"The training significantly improved both posttest and delayed-test performance compared with no training (F posttest  = 26.65, p < 0.001, Partial η 2  = 0.23; F delayed test  = 38.03, p < 0.001, Partial η 2  = 0.30).","['Chinese medical students', 'Ninety-one third-year undergraduate medical students', 'Chinese students in medical statistics during the COVID-19 pandemic']",['erroneous example elaboration training'],"['Prerequisite course performance and learning motivation', 'metacognitive load', 'posttest and delayed-test performance']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C3541364', 'cui_str': 'Erroneous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0588841,"The training significantly improved both posttest and delayed-test performance compared with no training (F posttest  = 26.65, p < 0.001, Partial η 2  = 0.23; F delayed test  = 38.03, p < 0.001, Partial η 2  = 0.30).","[{'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Junyi', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'College of Psychology, Sichuan Normal University, Chengdu, China. junyili@sicnu.edu.cn.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'College of Psychology, Sichuan Normal University, Chengdu, China.'}, {'ForeName': 'Yijing', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'College of Psychology, Sichuan Normal University, Chengdu, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Orthodontics, Shanghai Xuhui District Dental Disease Prevention and Control Institute, Shanghai, China.'}, {'ForeName': 'Jinyang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Oral and Cranio-maxillofacial Surgery, Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}]",BMC medical education,['10.1186/s12909-022-03460-1']
2166,35711147,"The Safety, Toleration, and Pharmacokinetics of Two Intravenous Voriconazole Formulations in Healthy Chinese Volunteers After Increasing Dose Administrations.","Sulfobutyl ether-beta-cyclodextrin sodium salt contained in the marketed intravenous voriconazole injection as a solubilizer may cause harmful accumulations. This study aimed to evaluate the safety, tolerability, and pharmacokinetics (PKs) of two intravenous voriconazole formulations containing excipients from different manufacturers using increasing dose administrations in healthy Chinese volunteers. A randomized, double-blind, placebo-controlled trial was conducted in three cohorts with 42 healthy Chinese volunteers. Each cohort of 14 volunteers was allocated in proportion (8:4:2) to test the formulation, reference voriconazole, or placebo successively by single-dose then multiple-dose administrations of 3, 4, and 6 mg/kg. Forty-one volunteers completed all drug administrations. The pharmacokinetics of test formulations are characterized by high interindividual variability (coefficient of variance of C max  up to 68.0%, AUC 0-τ  up to 70.2%, and nonlinear PKs with a regression coefficient of C max   = 1.31 and AUC 0-τ   = 1.75 in a single dose). In the steady state, R Auc  of the test drug versus reference drug of the 3, 4, and 6 mg/kg dose group were 5.2 and 5.3, 5.6 and 6.3, and 5.8 and 5.5, respectively, and Rc max  were 2.5 and 2.7, 2.6 and 3.1, and 2.8 and 2.6, respectively. Eighty-three adverse events with 37 transient visual disturbances were mild. PKs with high interindividual variability, nonlinear characteristics, and significant dose-dependent accumulation were comparable between the two formulations. Overall, the safety of the test formulation was acceptable.",2022,"PKs with high interindividual variability, nonlinear characteristics, and significant dose-dependent accumulation were comparable between the two formulations.","['Healthy Chinese Volunteers', '14 volunteers', 'three cohorts with 42 healthy Chinese volunteers', 'healthy Chinese volunteers']","['Sulfobutyl ether-beta-cyclodextrin sodium salt', 'placebo', 'voriconazole formulations', 'voriconazole, or placebo']","['Rc max', 'Safety, Toleration, and Pharmacokinetics', 'safety, tolerability, and pharmacokinetics (PKs']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0296727', 'cui_str': 'sulfobutylether-beta-cyclodextrin'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",14.0,0.158501,"PKs with high interindividual variability, nonlinear characteristics, and significant dose-dependent accumulation were comparable between the two formulations.","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Zejuan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Zhen', 'Affiliation': 'GCP Office, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Mengke', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Zang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Huiting', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': ""Department of Pharmacy, Jiangxi Children's Hospital, Nanchang Hospital, Nanchang, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1126']
2167,35711112,Onset of efficacy and adverse events during Cenobamate titration period.,"OBJECTIVES


Cenobamate is an antiseizure medication (ASM) approved in Europe as adjunctive therapy for adults with inadequately controlled focal seizures. This post hoc analysis reports onset of efficacy and characterizes time to onset, duration, and severity of the most common treatment-emergent adverse events (TEAEs) during cenobamate titration.
MATERIALS & METHODS


Adult patients with uncontrolled focal seizures taking 1 to 3 concomitant ASMs were randomized to receive adjunctive cenobamate or placebo (double-blind studies C013 and C017) or cenobamate (open-label study C021). Outcome assessments included efficacy (median percentage change in seizure frequency and onset [studies C013 and C017]) and safety (onset, duration, and severity of TEAEs [all studies]).
RESULTS


Onset of efficacy was observed by Weeks 1 to 4 of titration in studies C013 and C017 which used a faster titration schedule than study CO21. In study C013, the median percentage seizure frequency reduction was 36.7% in patients receiving cenobamate versus 16.3% in those taking placebo (p = .002); in study C017, significant differences in seizure frequency emerged in Week 1 and continued throughout titration between all cenobamate groups and placebo (p < .001). The most commonly reported TEAEs were somnolence, dizziness, fatigue, and headache, with first onset of each reported as early as Week 1; however, the majority resolved.
CONCLUSIONS


Reductions in seizure frequency occurred during titration with initial efficacy observed prior to reaching the target dose. These reductions were regarded as clinically meaningful because they may indicate early efficacy at lower doses than previously expected and had a considerable impact on patient quality of life. Long-term treatment with adjunctive cenobamate was generally safe and well-tolerated.",2022,"In study C013, the median percentage seizure frequency reduction was 36.7% in patients receiving cenobamate versus 16.3% in those taking placebo (p = .002); in study C017, significant differences in seizure frequency emerged in Week 1 and continued throughout titration between all cenobamate groups and placebo (p < .001).","['adults with inadequately controlled focal seizures', 'Adult patients with uncontrolled focal seizures taking 1 to 3 concomitant ASMs']","['antiseizure medication (ASM', 'adjunctive cenobamate', 'placebo', 'adjunctive cenobamate or placebo (double-blind studies C013 and C017) or cenobamate (open-label study C021']","['median percentage seizure frequency reduction', 'safe and well-tolerated', 'seizure frequency', 'somnolence, dizziness, fatigue, and headache', 'patient quality of life', 'efficacy (median percentage change in seizure frequency and onset [studies C013 and C017]) and safety (onset, duration, and severity of TEAEs [all studies']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0242536', 'cui_str': 'Eastern Samoa'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.254876,"In study C013, the median percentage seizure frequency reduction was 36.7% in patients receiving cenobamate versus 16.3% in those taking placebo (p = .002); in study C017, significant differences in seizure frequency emerged in Week 1 and continued throughout titration between all cenobamate groups and placebo (p < .001).","[{'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Department for Adults, Kork Epilepsy Center, Kehl-Kork, Germany.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Ben-Menachem', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Department of General Epileptology, Bethel Epilepsy Centre, Mara Hospital, University Hospital for Epileptology, Bielefeld, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'García Morales', 'Affiliation': 'Servicio de Neurología, Programa de Epilepsia, Hospital Ruber Internacional, Madrid, Spain.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Missouri, USA.'}, {'ForeName': 'Estevo', 'Initials': 'E', 'LastName': 'Santamarina', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Serratosa', 'Affiliation': 'Epilepsy Unit, Department of Neurology, Fundación Jiménez Díaz, Madrid, Spain.'}]",Acta neurologica Scandinavica,['10.1111/ane.13659']
2168,35711102,The effect of egg white diet on phosphorus control in dialysis patients.,"INTRODUCTION


Nutritional interventions have been envisaged to improve hyperphosphatemia and malnutrition, two important risk factors associated with mortality in dialysis patients. We evaluated the effects of egg white consumption on serum phosphate and malnutrition in dialysis patients.
METHODS


In an open-label, per protocol clinical trial, conducted in Kerman dialysis centers, 150 hemodialysis patients aged ≥18 years with serum phosphorus ≥5.5 mg/dl were included in the study. All participants limited their intake of foods containing phosphorus for 4 weeks, and then they were divided into a control and an intervention group. The control group continued their ordinary diet and the participants in the intervention group consumed a Telavang egg white pack (containing six egg whites, 96 calories, 24 g protein) as a substitute for meat products 3 days a week for 8 weeks. Finally, changes in serum albumin, phosphorus, calcium, PTH, and cholesterol were measured.
FINDINGS


At the baseline, there were no significant differences in the laboratory variables between the two groups. After 8 weeks, serum cholesterol (124.3 ± 38.1, vs. 135.8 ± 28.8, p = 0.003) and phosphorus levels (4.5 ± 1.03, vs. 6.7 ± 1.5, p = 0.001) were significantly lower in the intervention group compared with the control group. Also, serum albumin (4.5 ± 0.07 vs. 3.7 ± 0.4, p = 0.001) was significantly higher in the intervention group. Moreover, phosphorus, PTH, and cholesterol levels in the intervention group were significantly lower than their baseline values (p = 0.001).
CONCLUSION


The results showed that the egg white could be a useful source of protein for dialysis patients, as it simultaneously reduces serum phosphorus and cholesterol, and increases serum albumin.",2022,"Also, serum albumin (4.5 ± 0.07 vs. 3.7 ± 0.4, p = ","['dialysis patients', '150 hemodialysis patients aged ≥18\u2009years with serum phosphorus ≥5.5\u2009mg/dl were included in the study']","['ordinary diet and the participants in the intervention group consumed a Telavang egg white pack (containing six egg whites, 96 calories, 24 g protein', 'egg white consumption', 'egg white diet']","['serum albumin, phosphorus, calcium, PTH, and cholesterol', 'serum phosphate and malnutrition', 'serum cholesterol', 'phosphorus levels', 'serum phosphorus and cholesterol, and increases serum albumin', 'serum albumin', 'phosphorus, PTH, and cholesterol levels']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0450405', 'cui_str': '24G'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",150.0,0.0208165,"Also, serum albumin (4.5 ± 0.07 vs. 3.7 ± 0.4, p = ","[{'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Azmandian', 'Affiliation': 'Physiology Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Shamspour', 'Affiliation': 'Clinical Research Development Unit, Shafa Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Alinaghi Langari', 'Affiliation': 'Department of Internal Medicine, Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Talaei Khales Soflaei', 'Affiliation': 'Faculty of Public Health, Department of Nutrition, Cardiovascular Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alinaghi Langari', 'Affiliation': 'Student Research Committee, Afzalipour Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Habibeh', 'Initials': 'H', 'LastName': 'Ahmadipour', 'Affiliation': 'Afzalipour Faculty of Medicine, Department of Community Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mousavi', 'Affiliation': 'Shafa Hospital, and Endocrinology and Metabolism Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Masoumi', 'Affiliation': 'Physiology Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.13028']
2169,35711093,Early changes in estimated glomerular filtration rate post-initiation of empagliflozin in EMPEROR-Reduced.,"BACKGROUND


Sodium glucose co-transporter 2 inhibitors (SGLT2i) may induce an early post-initiation eGFR decrease which does not impact the SGLT2i benefits. The occurrence, characteristics, determinants, and clinical significance of an initial eGFR change among patients with heart failure with reduced ejection fraction (HFrEF) require further study.
AIMS


To describe eGFR change from randomisation to week 4 (as % of change relative to randomisation) and assess its impact in EMPEROR-Reduced.
METHODS


Landmark analyses (week 4) were performed.
RESULTS


eGFR change was available in 3547 patients out of 3730 (95%). The tertiles of post initiation eGFR % change for empagliflozin were: tertile 1 (T1) ≤-11.4%; T2 ≥-11.4% to ≤-1.0% and T3 ≥0.0%. The placebo group tertiles were: T1 ≤-6.5%; T2 ≥-6.4% to ≤+3.6%; and T3 ≥+3.6%. On average, empagliflozin induced a leftward distributional shift of initial eGFR changes of -2.5 ml/min/1.73m 2  vs. placebo. In the empagliflozin group, after covariate adjustment, the risk of cardiovascular and renal outcomes did not differ between patients in whom early post treatment initiation eGFR decreased (T1) and patients in whom it increased (T3). However, in the placebo group, patients in whom early post treatment initiation eGFR decreased (T1) had a higher risk of sustained worsening kidney function and all-cause mortality compared to patients in whom eGFR increased (T3): HR 2.38, 95%CI 1.25-4.55 and HR 1.37, 95%CI 1.01-1.85, respectively.
CONCLUSION


A mild eGFR decrease may be expected after the initiation of empagliflozin, and it is not associated with untoward HF, mortality or kidney safety events. Clinicians should not be concerned with early eGFR changes post-initiation of empagliflozin. This article is protected by copyright. All rights reserved.",2022,"In the empagliflozin group, after covariate adjustment, the risk of cardiovascular and renal outcomes did not differ between patients in whom early post treatment initiation eGFR decreased (T1) and patients in whom it increased (T3).","['3547 patients out of 3730 (95', 'patients with heart failure with reduced ejection fraction (HFrEF) require further study']","['empagliflozin', 'placebo']","['initiation eGFR', 'risk of cardiovascular and renal outcomes', 'higher risk of sustained worsening kidney function and all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0659532,"In the empagliflozin group, after covariate adjustment, the risk of cardiovascular and renal outcomes did not differ between patients in whom early post treatment initiation eGFR decreased (T1) and patients in whom it increased (T3).","[{'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Inserm, Center d'Investigations Cliniques, - Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Inserm, Center d'Investigations Cliniques, - Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gregson', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Bettina Johanna', 'Initials': 'BJ', 'LastName': 'Kraus', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mattheus', 'Affiliation': 'Biostatistics, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim.'}, {'ForeName': 'Sibylle Jenny', 'Initials': 'SJ', 'LastName': 'Hauske', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Baylor Scott and White Research Institute, TX and University of Mississippi, Jackson, MS, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.2578']
2170,35711070,Comparison of Transfer Learning Models in Pelvic Tilt and Rotation Measurement in Pediatric Anteroposterior Pelvic Radiographs.,"The rotation and tilt of the pelvis during anteroposterior pelvic radiography can lead to misdiagnosis of developmental dysplasia of the hip (DDH) in children. At present, no method exists for accurately and conveniently measuring the precise rotation and tilt angles of pelvic on radiographs. The objective of this study was to develop several rotation and tilt measurement models using transfer learning and digital reconstructed radiographs (DRRs), and to compare their performances on pelvic radiographs. Based on the inclusion criteria, 30 of 92 children who underwent 3D hip CT scans at Xijing Hospital from 2015 to 2020 were included in the study. Using DRR techniques, radiographs were generated by rotating and tilting the pelvis in CT datasets at - 12 to 12° (projected every 3°) and were randomized to a 2:1:1 ratio of training dataset, validation dataset, and test dataset. Five pre-trained networks, including VGG16, Xception, VGG19, ResNet50 and InceptionV3 were used to develop pelvic rotation measurement models and tilt measurement models, and these models were trained with training dataset. The callback function was used during the training to slow down the learning rate when learning was stalled. Then, the validation set was used to optimize each model and compare their performances. At last, we tested the final performances of optimal rotation measurement model and optimal tilt measurement model on test dataset. The mean absolute error (MAE) was employed to assess the performance of the models. A total of 2430 pelvic DRRs were collected based on 30 CT datasets. Among 5 pre-trained transfer learning models, VGG16-Tilt achieved the best tilt prediction performance at the same BS and different LR. VGG16-Tilt model achieved its best performance on validation set at LR = 0.001 and BS = 4, and the final MAE on the test set was 0.5250°. In terms of rotation prediction, VGG16-Rotation also achieved the best performance, and it achieved its best performance on validation set at LR = 0.002 and BS = 8. The final MAE of VGG16-Rotation on the test set was 1.0731°. Pretrained transfer learning models worked well in predicting tilt and rotation angles of the pelvis on radiographs in children. Among them, VGG16-Tilt and VGG16-Rotation had the best effect in dealing with such problems despite their simple structures. These models deployed in devices can give orthopedic surgeons a powerful aid in DDH diagnosis.",2022,"In terms of rotation prediction, VGG16-Rotation also achieved the best performance, and it achieved its best performance on validation set at LR = 0.002 and BS = 8.","['Pediatric Anteroposterior Pelvic Radiographs', 'children', '92 children who underwent 3D hip CT scans at Xijing Hospital from 2015 to 2020 were included in the study']","['Transfer Learning Models', 'transfer learning and digital reconstructed radiographs (DRRs']",['mean absolute error (MAE'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0412643', 'cui_str': 'CT of hip'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4760635', 'cui_str': 'Transfer Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0286540', 'cui_str': 'MAV protocol'}]",2430.0,0.0221968,"In terms of rotation prediction, VGG16-Rotation also achieved the best performance, and it achieved its best performance on validation set at LR = 0.002 and BS = 8.","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Xijing Hospital, Air Force Military Medical University, No.169 Changle West Road, Xi'an, Shaanxi Province, 710032, China.""}, {'ForeName': 'Yabo', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Orthopedics, Xijing Hospital, Air Force Military Medical University, No.169 Changle West Road, Xi'an, Shaanxi Province, 710032, China.""}, {'ForeName': 'Huifa', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedics, Xijing Hospital, Air Force Military Medical University, No.169 Changle West Road, Xi'an, Shaanxi Province, 710032, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': ""School of Electrical Engineering, Xi'an Jiaotong University, No.28 West Xianning Road, Xi'an, Shaanxi, 710049, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Medicine, Preventive Medicine School, Air Force Military Medical University, No.169 Changle West Road, Xi'an, Shaanxi, 710032, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Sha', 'Affiliation': ""Department of Orthopedics, Xijing Hospital, Air Force Military Medical University, No.169 Changle West Road, Xi'an, Shaanxi Province, 710032, China.""}, {'ForeName': 'Zongzhi', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': ""Department of Orthopedics, Xijing Hospital, Air Force Military Medical University, No.169 Changle West Road, Xi'an, Shaanxi Province, 710032, China.""}, {'ForeName': 'Luyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, Xijing Hospital, Air Force Military Medical University, No.169 Changle West Road, Xi'an, Shaanxi Province, 710032, China. Huangly@fmmu.edu.cn.""}]",Journal of digital imaging,['10.1007/s10278-022-00672-1']
2171,35711006,Effects of odanacatib on bone-turnover markers in osteoporotic postmenopausal women: a post hoc analysis of the LOFT study.,"This post hoc analysis and modeling study examined the mechanism of action of odanacatib using a statistical model to explain sCTx response in ODN-treated patients as a function of other bone-turnover biomarkers that, with other observed biomarker changes, showed that odanacatib persistently inhibited osteoclastic bone removal activity without preventing osteoclastogenesis.
INTRODUCTION


Odanacatib (ODN) is an oral selective cathepsin K (CatK) inhibitor, previously in development for osteoporosis treatment. A post hoc analysis examined ODN's mechanism of action on bone-turnover biomarkers.
METHODS


A subset of patients who completed 60 months' treatment in the Long-Term Odanacatib Fracture Trial (LOFT; NCT00529373) (N = 112 [57 ODN, 55 placebo]) were evaluated. Serum (s) and urine (u) samples were assayed at baseline and months 6-60 for 10 known bone-remodeling biomarkers: sCTx, uαα- and uββCTx/Cr, uNTx/Cr, sNTx, uDPD/Cr, sICTP, sTRAP5b, sPINP, and sBSAP. Because the CrossLaps® CTx assay identifies the CTx peptide as well as larger molecular weight CTx-containing peptides, including ICTP, a best-fit model was developed to explain the transient sCTx reduction in ODN-treated patients.
RESULTS


ODN persistently reduced the bone-resorption markers sNTx, uNTx/Cr, uαα- and uββCTx/Cr, and uDPD/Cr, and gradually increased the target-engagement marker sICTP and osteoclast number (sTRAP5b), versus placebo from baseline to month 60. sCTx was transiently reduced with ODN within 12 months, returning to baseline by month 48. Modeling suggested that sCTx changes in the ODN group were primarily due to increased accumulation of larger CTx species, including sICTP. The bone-formation markers sPINP and sBSAP showed partial reductions, versus placebo, in the first 6 months but approached baseline by months 48-60.
CONCLUSION


Observed changes in bone-turnover biomarkers support the persistent efficacy of ODN in direct inhibition of osteoclastic bone-resorption activity, without inhibition of osteoclastogenesis. Long-term evaluation also underscores the unique mechanism of ODN on osteoclastic collagen processing and subsequently osteoblastic bone formation.
TRIAL REGISTRATION


NCT00529373.",2022,"The bone-formation markers sPINP and sBSAP showed partial reductions, versus placebo, in the first 6 months but approached baseline by months 48-60.
",['osteoporotic postmenopausal women'],"['Odanacatib (ODN', 'odanacatib', 'placebo']","['bone-turnover markers', 'bone-resorption markers sNTx, uNTx/Cr, uαα- and uββCTx/Cr, and uDPD/Cr, and gradually increased the target-engagement marker sICTP and osteoclast number (sTRAP5b', 'sCTx', 'Serum (s) and urine (u) samples']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2351970', 'cui_str': 'odanacatib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0029431', 'cui_str': 'Osteoclast'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",,0.0805953,"The bone-formation markers sPINP and sBSAP showed partial reductions, versus placebo, in the first 6 months but approached baseline by months 48-60.
","[{'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Duong', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA. seth_clark@merck.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pickarski', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Giezek', 'Affiliation': 'MSD Europe Inc., Brussels, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cohn', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Massaad', 'Affiliation': 'MSD Europe Inc., Brussels, Belgium.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc., Rahway, NJ, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-022-06406-x']
2172,35710990,A randomized controlled trial to test financial incentives for COVID-19 vaccination in Ghana.,,2022,,['Ghana'],[],[],"[{'cui': 'C0017516', 'cui_str': 'Ghana'}]",[],[],,0.54424,,"[{'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Duch', 'Affiliation': 'Nuffield College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Asiedu', 'Affiliation': 'University of Ghana, Accra, Ghana.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Hitotsubashi Institute for Advanced Study, Hitotsubashi University, Tokyo, Japan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rouyard', 'Affiliation': 'Hitotsubashi Institute for Advanced Study, Hitotsubashi University, Tokyo, Japan.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Yevenes', 'Affiliation': 'Centre for Experimental Social Sciences, University of Santiago of Chile (USACH), Santiago, Chile.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Roope', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Violato', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK. Philip.clarke@ndph.ox.ac.uk.'}]",Nature medicine,['10.1038/s41591-022-01876-2']
2173,35705380,"Triggering with 1,500 IU of human chorionic gonadotropin plus follicle-stimulating hormone compared to a standard human chorionic gonadotropin trigger dose for oocyte competence in in vitro fertilization cycles: a randomized, double-blinded, controlled noninferiority trial.","OBJECTIVE


To assess if triggering with 1,500 IU of human chorionic gonadotropin (hCG) with 450 IU of follicle-stimulating hormone (FSH) induces noninferior oocyte competence to a standard dose of hCG trigger used in in vitro fertilization (IVF). The alternative trigger will be considered noninferior if it is at least 80% effective in promoting oocyte competence.
DESIGN


Randomized, double-blinded, controlled noninferiority trial.
SETTING


Academic infertility practice.
PATIENTS


Women aged 18-41 undergoing IVF with antral follicle count ≥8, body mass index ≤30 kg/m 2 , and no history of ≥2 IVF cycles canceled for poor response were enrolled. Participants with a serum estradiol >5,000 pg/mL on the day of trigger were excluded because of high risk of ovarian hyperstimulation syndrome.
INTERVENTIONS


Participants were randomized to receive an alternative trigger of 1,500 IU of hCG plus 450 IU of FSH or a standard trigger dose of hCG (5,000 or 10,000 IU) for final oocyte maturation.
MAIN OUTCOME MEASURES


The primary outcome was total competent proportion, defined as the probability of 2 pronuclei from an oocyte retrieved. The alternative trigger will be considered noninferior to the standard trigger if a 1-sided 95% confidence interval (CI) of the relative risk (RR) is not <0.8. Secondary outcomes included oocyte recovery and maturity, intracytoplasmic sperm injection fertilization, embryo quality, pregnancy rates, as well as serum and follicular hormones. Secondary outcomes were compared using a 2-sided superiority test. Outcomes were analyzed by intention-to-treat and per-protocol.
RESULTS


A total of 105 women undergoing IVF were randomized from May 2015 to June 2018. The probability of the primary outcome was 0.59 with the alternative trigger and 0.65 with the standard trigger, with a RR of 0.91 and a 1-sided 95% CI of 0.83. Noninferiority of the alternative trigger was demonstrated. Live birthrate from all fresh transfers in the alternative trigger group vs. standard trigger was 46.9 vs. 46.4% (RR, 1.01; 95% CI, 0.62-1.62), respectively. Live birthrate per randomized participant was 48.1% in the alternative trigger group vs. 62.7% with the standard trigger (RR, 0.73; 95% CI, 0.48-1.11). No participants had a failed retrieval.
CONCLUSION


Triggering with 1,500 IU of hCG plus 450 IU of FSH promoted noninferior oocyte competence compared to a standard hCG trigger dose.
TRIAL REGISTRATION


NCT02310919.",2022,"Secondary outcomes included oocyte recovery and maturity, intracytoplasmic sperm injection fertilization, embryo quality, pregnancy rates, as well as serum and follicular hormones.","['Academic infertility practice', '105 women undergoing IVF were randomized from May 2015 to June 2018', 'vitro fertilization cycles', 'Participants with a serum estradiol >5,000 pg/mL on the day of trigger were excluded because of high risk of ovarian hyperstimulation syndrome', 'Women aged 18-41 undergoing IVF with antral follicle count ≥8, body mass index ≤30 kg/m 2 , and no history of ≥2 IVF cycles canceled for poor response were enrolled']","['hCG', 'FSH', 'human chorionic gonadotropin (hCG) with 450 IU of follicle-stimulating hormone (FSH', 'standard human chorionic gonadotropin trigger', 'hCG plus 450 IU of FSH or a standard trigger dose of hCG', 'human chorionic gonadotropin plus follicle-stimulating hormone']","['oocyte recovery and maturity, intracytoplasmic sperm injection fertilization, embryo quality, pregnancy rates, as well as serum and follicular hormones', 'total competent proportion, defined as the probability of 2 pronuclei from an oocyte retrieved']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0205544', 'cui_str': 'Canceled'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]",105.0,0.716861,"Secondary outcomes included oocyte recovery and maturity, intracytoplasmic sperm injection fertilization, embryo quality, pregnancy rates, as well as serum and follicular hormones.","[{'ForeName': 'Yanett', 'Initials': 'Y', 'LastName': 'Anaya', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Center for Reproductive Health, University of California San Francisco, San Francisco, California. Electronic address: Yanett.anaya2@ucsf.edu.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Cakmak', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Center for Reproductive Health, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Mata', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Letourneau', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Center for Reproductive Health, University of California San Francisco, San Francisco, California; Division of Reproductive Endocrinology and Infertility, Utah Center for Reproductive Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Lenhart', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Center for Reproductive Health, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Flor', 'Initials': 'F', 'LastName': 'Juarez-Hernandez', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Center for Reproductive Health, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Jalalian', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Center for Reproductive Health, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Center for Reproductive Health, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Rosen', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Center for Reproductive Health, University of California San Francisco, San Francisco, California.'}]",Fertility and sterility,['10.1016/j.fertnstert.2022.05.006']
2174,35705354,"High-definition transcranial infraslow pink noise stimulation for chronic low back pain: protocol for a pilot, safety and feasibility randomised placebo-controlled trial.","INTRODUCTION


Chronic low back pain (CLBP) is a common disabling health condition. Current treatments demonstrate modest effects, warranting newer therapies. Brain imaging demonstrates altered electrical activities in cortical areas responsible for pain modulation, emotional and sensory components of pain experience. Treatments targeting to change electrical activities of these key brain regions may produce clinical benefits. This pilot study aims to (1) evaluate feasibility, safety and acceptability of a novel neuromodulation technique, high-definition transcranial infraslow pink noise stimulation (HD-tIPNS), in people with CLBP, (2) explore the trend of effect of HD-tIPNS on pain and function, and (3) derive treatment estimates to support sample size calculation for a fully powered trial should trends of effectiveness be present.
METHODS AND ANALYSIS


A pilot, triple-blinded randomised two-arm placebo-controlled parallel trial. Participants (n=40) with CLBP will be randomised to either sham stimulation or HD-tIPNS (targeting somatosensory cortex and dorsal and pregenual anterior cingulate cortex). Primary outcomes include feasibility and safety measures, and clinical outcomes of pain (Brief Pain Inventory) and disability (Roland-Morris disability questionnaire). Secondary measures include clinical, psychological, quantitative sensory testing and electroencephalography collected at baseline, immediately postintervention, and at 1-week, 1-month and 3 months postintervention. All data will be analysed descriptively. A nested qualitative study will assess participants perceptions about acceptability of intervention and analysed thematically.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from Health and Disability Ethics Committee (Ref:20/NTB/67). Findings will be reported to regulatory and funding bodies, presented at conferences, and published in a scientific journal.
TRIAL REGISTRATION NUMBER


ACTRN12620000505909p.",2022,"Primary outcomes include feasibility and safety measures, and clinical outcomes of pain (Brief Pain Inventory) and disability (Roland-Morris disability questionnaire).","['Participants (n=40) with CLBP', 'people with CLBP, (2', 'chronic low back pain']","['sham stimulation or HD-tIPNS', 'placebo', 'High-definition transcranial infraslow pink noise stimulation', 'novel neuromodulation technique, high-definition transcranial infraslow pink noise stimulation (HD-tIPNS', 'HD-tIPNS']","['feasibility, safety and acceptability', 'feasibility and safety measures, and clinical outcomes of pain (Brief Pain Inventory) and disability (Roland-Morris disability questionnaire', 'clinical, psychological, quantitative sensory testing and electroencephalography']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",40.0,0.44822,"Primary outcomes include feasibility and safety measures, and clinical outcomes of pain (Brief Pain Inventory) and disability (Roland-Morris disability questionnaire).","[{'ForeName': 'Divya Bharatkumar', 'Initials': 'DB', 'LastName': 'Adhia', 'Affiliation': 'Department of Surgical Sciences, and Pain@Otago Research Theme, University of Otago - Dunedin Campus, Dunedin, New Zealand divya.adhia@otago.ac.nz.'}, {'ForeName': 'Ramakrishnan', 'Initials': 'R', 'LastName': 'Mani', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, and Pain@Otago Research Theme, University of Otago - Dunedin Campus, Dunedin, New Zealand.'}, {'ForeName': 'John N J', 'Initials': 'JNJ', 'LastName': 'Reynolds', 'Affiliation': 'Department of Anatomy and the Brain Health Research Centre, University of Otago - Dunedin Campus, Dunedin, New Zealand.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Vanneste', 'Affiliation': 'School of Psychology, Global Brain Health Institute, Institute of Neuroscience, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'De Ridder', 'Affiliation': 'Department of Surgical Sciences, and Pain@Otago Research Theme, University of Otago - Dunedin Campus, Dunedin, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2021-056842']
2175,35705204,Infralow neurofeedback in the treatment of substance use disorders: a randomized controlled trial.,"BACKGROUND


Infralow neurofeedback (ILF-NF) was recently developed as a subtype of traditional, frequency-based neurofeedback that targets cerebral rhythmic activity below 0.5 Hz and improves brain self-regulation. The efficacy of ILF-NF in the treatment of substance use disorder has not yet been evaluated, but clinical evidence suggests that it may prevent relapse by improving functioning in various life domains. The current study aimed to fill this research gap and extend empirical evidence related to this issue.
METHODS


Ninety-three patients with substance use disorders at an outpatient unit in Norway were randomized to receive 20 sessions (30 minutes each) of ILF-NF training combined with treatment as usual (TAU), or TAU alone. The primary outcome was quality of life post-treatment as an overall measure of functioning. We analyzed between-group differences using Student  t  tests.
RESULTS


We found no significant differences in quality of life between groups. We found similar nonsignificant results for most of the secondary outcome measures, including drug use, sleep, anxiety and depression. Compared to TAU, the ILF-NF + TAU group reported significantly lower restlessness scores post-treatment (mean difference -1.8, 95 % confidence interval -3.1 to -0.5;  p  = 0.006). Limitations:  This study was limited by broad inclusion criteria and a lack of placebo control (sham neurofeedback treatment).
CONCLUSION


ILF-NF offered limited additional benefit when combined with TAU, except in the area of restlessness. Future studies could further investigate the relationship between ILF-NF, restlessness and substance use in targeted subpopulations to illuminate relapse mechanisms.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: NCT03356210.",2022,We found no significant differences in quality of life between groups.,"['substance use disorders', 'Ninety-three patients with substance use disorders at an outpatient unit in Norway']","['ILF-NF + TAU', 'ILF-NF', 'ILF-NF training combined with treatment as usual (TAU), or TAU alone']","['quality of life post-treatment as an overall measure of functioning', 'restlessness scores', 'drug use, sleep, anxiety and depression', 'quality of life']","[{'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",93.0,0.422575,We found no significant differences in quality of life between groups.,"[{'ForeName': 'Karin Berle', 'Initials': 'KB', 'LastName': 'Gabrielsen', 'Affiliation': 'From the Addiction Unit, Sørlandet Hospital, Kristiansand, Norway (Gabrielsen, Clausen, Vederhus); the Norwegian Centre for Addiction Research (SERAF), University of Oslo, Oslo, Norway (Clausen); the Department of Psychosocial Health, University of Agder, Grimstad, Norway (Haugland); the Norwegian University of Science and Technology, Trondheim, Norway (Hollup) karin.berle.gabrielsen@sshf.no.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clausen', 'Affiliation': 'From the Addiction Unit, Sørlandet Hospital, Kristiansand, Norway (Gabrielsen, Clausen, Vederhus); the Norwegian Centre for Addiction Research (SERAF), University of Oslo, Oslo, Norway (Clausen); the Department of Psychosocial Health, University of Agder, Grimstad, Norway (Haugland); the Norwegian University of Science and Technology, Trondheim, Norway (Hollup).'}, {'ForeName': 'Siri Håvås', 'Initials': 'SH', 'LastName': 'Haugland', 'Affiliation': 'From the Addiction Unit, Sørlandet Hospital, Kristiansand, Norway (Gabrielsen, Clausen, Vederhus); the Norwegian Centre for Addiction Research (SERAF), University of Oslo, Oslo, Norway (Clausen); the Department of Psychosocial Health, University of Agder, Grimstad, Norway (Haugland); the Norwegian University of Science and Technology, Trondheim, Norway (Hollup).'}, {'ForeName': 'Stig Arvid', 'Initials': 'SA', 'LastName': 'Hollup', 'Affiliation': 'From the Addiction Unit, Sørlandet Hospital, Kristiansand, Norway (Gabrielsen, Clausen, Vederhus); the Norwegian Centre for Addiction Research (SERAF), University of Oslo, Oslo, Norway (Clausen); the Department of Psychosocial Health, University of Agder, Grimstad, Norway (Haugland); the Norwegian University of Science and Technology, Trondheim, Norway (Hollup).'}, {'ForeName': 'John-Kåre', 'Initials': 'JK', 'LastName': 'Vederhus', 'Affiliation': 'From the Addiction Unit, Sørlandet Hospital, Kristiansand, Norway (Gabrielsen, Clausen, Vederhus); the Norwegian Centre for Addiction Research (SERAF), University of Oslo, Oslo, Norway (Clausen); the Department of Psychosocial Health, University of Agder, Grimstad, Norway (Haugland); the Norwegian University of Science and Technology, Trondheim, Norway (Hollup).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.210202']
2176,35705194,Effect of 8-week intake of the omega-3 fatty acid-rich perilla oil on the gut function and as a fuel source for female athletes: A randomised trial.,"Previous studies have examined the effects of omega-3 fatty acid intake in supplement form or fish oil capsules but there are few studies based on other foods. Perilla oil is a traditional Japanese seed oil rich in omega-3 fatty acids. This randomised trial aimed to determine the appropriate omega-3 fatty acid dose through consumption of perilla oil, which improves gut function and microbiota in trained athletes, and the amount of fat fuel required to provide energy to athletes involved in high-intensity training to improve athletic performance. Thirty-six female athletes training six times per week were randomly assigned to three groups according to perilla oil intake: 9 g/day (HOI), 3 g/day (LOI), and placebo-supplementation (PLA) groups. The HOI and LOI groups had perilla oil-containing jelly and the PLA group had placebo jelly for 8 weeks. Gut microbiota, constipation score, and urinary biochemical index were measured pre- and post-intervention. The spoilage bacteria,  Proteobacteria , significantly decreased ( P =  0.036,  d  = 0.53), whereas  Butyrate -producing bacteria,  Lachnospiraceae , significantly increased ( P =  0.007,  d  = 1.2) in the HOI group. Urinary indoxyl sulphate significantly decreased in the HOI group only ( P =  0.010,  d  = 0.82). Changes in the constipation score were significantly lower in the HOI group ( P =  0.020) and even lower in the LOI group ( P =  0.073) than in the PLA group; there were significant differences between groups ( P =  0.035). Therefore, perilla oil intake may improve gut function and microbiota in athletes, with higher doses resulting in further improvement.",2022,Changes in the constipation score were significantly lower in the HOI group ( P =  0.020) and even lower in the LOI group ( P =  0.073) than in the PLA group; there were significant differences between groups ( P =  0.035).,"['trained athletes', 'female athletes', 'Thirty-six female athletes training six times per week']","['placebo', 'Perilla oil', 'perilla oil intake', 'placebo-supplementation (PLA', 'omega-3 fatty acid intake', 'omega-3 fatty acid-rich perilla oil', 'appropriate omega-3 fatty acid dose through consumption of perilla oil']","['spoilage bacteria,  Proteobacteria', 'constipation score', 'Gut microbiota, constipation score, and urinary biochemical index', 'Butyrate -producing bacteria,  Lachnospiraceae', 'Urinary indoxyl sulphate']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0070421', 'cui_str': 'perilla seed oil'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0556124', 'cui_str': 'N-3 fatty acid intake'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C0063522', 'cui_str': 'indoxyl'}, {'cui': 'C0474702', 'cui_str': 'Sulfate measurement'}]",36.0,0.0567998,Changes in the constipation score were significantly lower in the HOI group ( P =  0.020) and even lower in the LOI group ( P =  0.073) than in the PLA group; there were significant differences between groups ( P =  0.035).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': 'Faculty of Sport Science, Nippon Sport Science University, Tokyo 1588508, Japan; aki.kawamura@nittai.ac.jp (A.K.), nemoto@nittai.ac.jp (K.N.).'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nemoto', 'Affiliation': 'Faculty of Sport Science, Nippon Sport Science University, Tokyo 1588508, Japan; aki.kawamura@nittai.ac.jp (A.K.), nemoto@nittai.ac.jp (K.N.).'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sugita', 'Affiliation': 'Faculty of Sport Science, Nippon Sport Science University, Tokyo 1588508, Japan; aki.kawamura@nittai.ac.jp (A.K.), nemoto@nittai.ac.jp (K.N.).'}]",The British journal of nutrition,['10.1017/S0007114522001805']
2177,35705512,Intergenerational effects of the Fast Track intervention on the home environment: A randomized control trial.,"BACKGROUND


Maladaptive family environments harm child development and are passed across generations. Childhood interventions may break this intergenerational cycle by improving the family environments children form as adults. The present study investigates this hypothesis by examining follow-up data collected 18 years after the end of the childhood Fast Track intervention designed to prevent externalizing problems.
METHODS


We examined whether Fast Track assignment from grades 1 to 10 prevented the emergence of maladaptive family environments at age 34. A total of 400 (n = 206 in intervention condition, n = 194 controls) Fast Track participants who were parents at age 34 were surveyed about 11 aspects of their current family environment. The hypotheses and analytic plan were preregistered at https://osf.io/dz9t5 and the Fast Track trial was registered at clinicaltrials.gov (NCT01653535).
RESULTS


Multiple group linear regression models revealed that mothers who participated in the Fast Track intervention as children had lower depression symptoms, alcohol problems, drug problems, corporal punishment use, and food insecurity compared to control group mothers. All effects were modest in magnitude. However, for these same mothers, the Fast Track intervention had no effect on cannabis problems, experiences of romantic partner violence, or maternal use of physical aggression or warmth with their children. Additionally, mothers in the Fast Track intervention group reported higher levels of family chaos than those in the control group, but this effect may be a byproduct of the higher number of children per household in the intervention group. No intervention effects were found for fathers who participated in the Fast Track intervention as children.
CONCLUSIONS


Childhood assignment to Fast Track has some beneficial effects for girls, but not boys, on the family environments these individuals formed as adults 18 years later.",2022,"However, for these same mothers, the Fast Track intervention had no effect on cannabis problems, experiences of romantic partner violence, or maternal use of physical aggression or warmth with their children.","['A total of 400 (n\u2009=\u2009206 in intervention condition, n\u2009=\u2009194 controls', 'family environments children form as adults', 'Fast Track participants who were parents at age 34 were surveyed about 11 aspects of their current family environment']",['Fast Track intervention'],"['cannabis problems, experiences of romantic partner violence, or maternal use of physical aggression or warmth with their children', 'higher levels of family chaos', 'depression symptoms, alcohol problems, drug problems, corporal punishment use, and food insecurity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0006912', 'cui_str': 'Death Penalty'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}]",400.0,0.0199516,"However, for these same mothers, the Fast Track intervention had no effect on cannabis problems, experiences of romantic partner violence, or maternal use of physical aggression or warmth with their children.","[{'ForeName': 'William Andrew', 'Initials': 'WA', 'LastName': 'Rothenberg', 'Affiliation': 'Center for Child and Family Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Lansford', 'Affiliation': 'Center for Child and Family Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Godwin', 'Affiliation': 'Center for Child and Family Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Dodge', 'Affiliation': 'Center for Child and Family Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Copeland', 'Affiliation': 'Center for Child and Family Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'Candice L', 'Initials': 'CL', 'LastName': 'Odgers', 'Affiliation': 'Center for Child and Family Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'McMahon', 'Affiliation': ""BC Children's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Goulter', 'Affiliation': 'Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Center for Child and Family Policy, Duke University, Durham, NC, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13648']
2178,35705502,"Pharmacokinetics of Intravenously (DIZ101), Subcutaneously (DIZ102), and Intestinally (LCIG) Infused Levodopa in Advanced Parkinson Disease.","BACKGROUND AND OBJECTIVES


Intestinal levodopa/carbidopa gel infusion (LCIG) is superior to oral treatment in advanced Parkinson's disease. The primary objectives of this trial were to investigate if continuous subcutaneous or intravenous infusion with a continuously buffered acidic levodopa/carbidopa solution yields steady state plasma concentrations of levodopa that are equivalent in magnitude, and non-inferior in variability, to those obtained with LCIG in patients with advanced Parkinson's disease.
METHODS


A concentrated acidic levodopa/carbidopa (8:1) solution buffered continuously and administered intravenously (DIZ101) or subcutaneously (DIZ102) was compared with an approved intestinal levodopa/carbidopa gel (LCIG) in a randomized, 3-period cross-over, open-label multicenter trial. Formulations were infused for 16h to patients with Parkinson's disease who were using LCIG as their regular treatment. Patients were recruited at several university neurology clinics but came to the same phase I unit for treatment. Pharmacokinetic variables and safety including dermal tolerance are reported. The primary outcomes were bioequivalence and non-inferior variability of DIZ101 and DIZ102 versus LCIG with respect to levodopa plasma concentrations.
RESULTS


With dosing adjusted to estimated bioavailability, DIZ101 and DIZ102 produced levodopa plasma levels within standard bioequivalence limits when compared to LCIG in the 18 participants that received all treatments. While the levodopa bioavailability for DIZ102 was complete, it was 80% for LCIG. Therapeutic concentrations of levodopa were reached as quickly with subcutaneous administration of DIZ102 as with LCIG and remained stable throughout the infusions. Due to poor uptake with LCIG, carbidopa levels in plasma were higher with DIZ101 and DIZ102 than with the former. All individuals receiving any of the treatments (n=20) were included in the evaluation of safety and tolerability. Reactions at the infusion sites were mild and transient.
DISCUSSION


It is feasible to rapidly achieve high and stable levodopa concentrations by means of continuous buffering of a subcutaneously administered acidic levodopa/carbidopa containing solution.
TRIAL REGISTRATION INFORMATION


ClinicalTrials.gov Identifier: NCT03419806. Registration first posted 5 Feb 2018, first patient enrolled 16 Feb 2018. Link to registration.",2022,"The primary outcomes were bioequivalence and non-inferior variability of DIZ101 and DIZ102 versus LCIG with respect to levodopa plasma concentrations.
","[""patients with Parkinson's disease who were using LCIG as their regular treatment"", 'Advanced Parkinson Disease', ""patients with advanced Parkinson's disease"", ""advanced Parkinson's disease"", 'All individuals receiving any of the treatments (n=20', 'Patients were recruited at several university neurology clinics but came to the same phase I unit for treatment']","['levodopa/carbidopa gel infusion (LCIG', 'acidic levodopa/carbidopa containing solution', 'acidic levodopa/carbidopa (8:1) solution buffered continuously and administered intravenously (DIZ101) or subcutaneously (DIZ102) was compared with an approved intestinal levodopa/carbidopa gel (LCIG', 'Levodopa', 'Pharmacokinetics of Intravenously (DIZ101), Subcutaneously (DIZ102), and Intestinally (LCIG', 'acidic levodopa/carbidopa solution']","['Therapeutic concentrations of levodopa', 'levodopa plasma levels', 'bioequivalence and non-inferior variability of DIZ101 and DIZ102 versus LCIG with respect to levodopa plasma concentrations', 'LCIG, carbidopa levels in plasma', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.133681,"The primary outcomes were bioequivalence and non-inferior variability of DIZ101 and DIZ102 versus LCIG with respect to levodopa plasma concentrations.
","[{'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Bergquist', 'Affiliation': 'Dept of Pharmacology, University of Gothenburg, Sweden filip.bergquist@pharm.gu.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Ehrnebo', 'Affiliation': 'Dept of Pharmaceutical Biosciences, Uppsala University, Swede.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Nyholm', 'Affiliation': 'Dept of Neuroscience, Uppsala University, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Johansson', 'Affiliation': 'Dept of Clinical Neurosciences, Karolinska Institutet, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Lundin', 'Affiliation': 'Dept of Biomedical and Clinical Sciences, Linköping University, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Odin', 'Affiliation': 'Neurology, Dept of Clinical Sciences, Lund University, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Svenningsson', 'Affiliation': 'Dept of Clinical Neurosciences, Karolinska Institutet, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Hansson', 'Affiliation': 'CTC Clinical Trial Consultants AB, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bring', 'Affiliation': 'Dizlin Pharmaceuticals, Sweden.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Eriksson', 'Affiliation': 'Dept of Pharmacology, University of Gothenburg, Sweden.'}, {'ForeName': 'Nil', 'Initials': 'N', 'LastName': 'Dizdar', 'Affiliation': 'Dept of Biomedical and Clinical Sciences, Linköping University, Sweden.'}]",Neurology,['10.1212/WNL.0000000000200804']
2179,35706121,Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Study.,"OBJECTIVE


The aim of the study was to compare the effectiveness of radial extracorporeal shock wave therapy and local corticosteroid injection on pain, function, and nerve conduction studies in the treatment of idiopathic carpal tunnel syndrome.
DESIGN


A total of 72 patients who were diagnosed as having carpal tunnel syndrome were included in the study. The radial extracorporeal shock wave therapy group received radial extracorporeal shock wave therapy, the local corticosteroid injection group received local corticosteroid injection, and the control group only used a resting hand splint. The patients were evaluated using a Visual Analog Scale-pain, a Visual Analog Scale-numbness, the Boston Symptom Severity Scale, the Boston Functional Status Scale, and handgrip strength tests before treatment 1 and 12 wks after the treatment.
RESULTS


Both clinical and nerve conduction study parameters improved with all three groups, and this effect continued at the 12th-week follow-up of the patients. The Visual Analog Scale-pain, Visual Analog Scale-numbness, Boston Symptom Severity Scale, and Boston Functional Status Scale scores in the first week after the treatment, as well as Visual Analog Scale-pain and Boston Functional Status Scale scores in the 12th week after the treatment, were significantly lower in the local corticosteroid injection group compared with the other two groups.
CONCLUSIONS


Our study revealed the success of radial extracorporeal shock wave therapy, splint, and local corticosteroid injection, but symptom relief was greater in the first week and 12th week with local corticosteroid injection.",2022,"Both clinical and nerve conduction study parameters improved with all three groups, and this effect continued at the 12th-week follow-up of the patients.","['idiopathic carpal tunnel syndrome', '72 patients who were diagnosed as having carpal tunnel syndrome', 'Patients With Carpal Tunnel Syndrome']","['Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness', 'radial extracorporeal shock wave therapy, the local corticosteroid injection group received local corticosteroid injection, and the control group only used a resting hand splint', 'radial extracorporeal shock wave therapy and local corticosteroid injection']","['symptom relief', 'Visual Analog Scale-pain, a Visual Analog Scale-numbness, the Boston Symptom Severity Scale, the Boston Functional Status Scale, and handgrip strength tests', 'pain, function, and nerve conduction studies', 'Visual Analog Scale-pain and Boston Functional Status Scale scores', 'Visual Analog Scale-pain, Visual Analog Scale-numbness, Boston Symptom Severity Scale, and Boston Functional Status Scale scores']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0409162', 'cui_str': 'Splinting of hand'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",72.0,0.0482975,"Both clinical and nerve conduction study parameters improved with all three groups, and this effect continued at the 12th-week follow-up of the patients.","[{'ForeName': 'Havva', 'Initials': 'H', 'LastName': 'Öztürk Durmaz', 'Affiliation': 'From the Ankara Şereflikoçhisar State Hospital, Ankara, Turkey (HÖD); Kirşehir Ahi Evran University Education and Research Hospital, Kirşehir, Turkey (FT); Ankara City Hospital, Ankara, Turkey (HD); and High Specialization University, Ankara, Turkey (HRE).'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Tuncay', 'Affiliation': ''}, {'ForeName': 'Himmet', 'Initials': 'H', 'LastName': 'Durmaz', 'Affiliation': ''}, {'ForeName': 'Hatice Rana', 'Initials': 'HR', 'LastName': 'Erdem', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001891']
2180,35706091,The Effects of Liposomal Bupivacaine on Long-term Outcomes and Decreasing Immediate Postoperative Opioid Use Following One-level and Two-level Posterior Lumbar Fusions.,"STUDY DESIGN


This is a retrospective observational study.
OBJECTIVE


This study aims to determine the efficacy of liposomal bupivacaine in postoperative analgesia and long-term outcomes in patients undergoing one-level and two-level posterior lumbar fusion.
SUMMARY OF BACKGROUND DATA


Multiple studies have investigated the use of liposomal bupivacaine in spine surgery with varying results. The potential benefits of its use include decreasing postoperative opioid use, improved pain control, and a shorter hospital stay. Several studies have supported its use in spine surgery with others showing minimal to no benefit. No studies have investigated its possible impact on long-term outcomes.
MATERIALS AND METHODS


A total of 42 patients (22 one-level, 20 two-level) received liposomal bupivacaine injection just before surgical closure and were compared with a historical control group of 42 patients (27 one-level, 15 two-level) that did not receive liposomal bupivacaine. Daily opioid consumption was collected and converted to oral morphine equivalents. Length of stay and daily average pain scores using the visual analog scale were also recorded. In addition, SF-36 bodily pain and physical function outcome measures were collected preoperatively and at 6 months, 1 year and 2 years postoperatively.
RESULTS


The liposomal bupivacaine group was found to have a significantly lower total opioid consumption compared with the control group (P=0.001). The liposomal bupivacaine group was also found to use significantly fewer opioids on the day of surgery compared with the control group (P<0.0001). There was no significant difference shown in the average visual analog scale pain scores, length of stay, or long-term outcomes between the 2 groups.
CONCLUSIONS


The use of liposomal bupivacaine in one-level and two-level posterior lumbar fusions shows promise as an adjuvant for postoperative analgesia by decreasing postoperative opioid consumption. With the varying results demonstrated with the utilization of liposomal bupivacaine in spine surgery, further investigation is warranted, namely a larger prospective randomized control study.
LEVEL OF EVIDENCE


Level III.",2022,The liposomal bupivacaine group was found to have a significantly lower total opioid consumption compared with the control group (P=0.001).,"['42 patients (22 one-level, 20 two-level) received', 'patients undergoing one-level and two-level posterior lumbar fusion']","['liposomal bupivacaine injection', 'Liposomal Bupivacaine', 'liposomal bupivacaine']","['visual analog scale', 'average visual analog scale pain scores, length of stay, or long-term outcomes', 'SF-36 bodily pain and physical function outcome measures', 'Length of stay and daily average pain scores', 'total opioid consumption', 'Daily opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C4060211', 'cui_str': 'Bupivacaine Injection [Sensorcaine]'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",42.0,0.104366,The liposomal bupivacaine group was found to have a significantly lower total opioid consumption compared with the control group (P=0.001).,"[{'ForeName': 'Emmett', 'Initials': 'E', 'LastName': 'Gannon', 'Affiliation': 'Departments of Orthopaedic Surgery.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Freeman', 'Affiliation': 'Departments of Orthopaedic Surgery.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Cornett', 'Affiliation': 'Departments of Orthopaedic Surgery.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Vincent', 'Affiliation': 'Departments of Orthopaedic Surgery.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Powers', 'Affiliation': 'College of Medicine.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lyden', 'Affiliation': 'Public Health-Biostatistics, University of Nebraska Medical Center, Omaha, NE.'}]",Clinical spine surgery,['10.1097/BSD.0000000000001354']
2181,35706085,Erratum: Fluvoxamine Treatment of Patients with Symptomatic COVID-19 in a Community Treatment Center: A Preliminary Result of Randomized Controlled Trial.,"This corrects the article on p. 102 in vol. 54, PMID: 35384422.",2022,This corrects the article on p. 102 in vol.,['Patients with Symptomatic COVID-19 in a Community Treatment Center'],['Fluvoxamine'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0085228', 'cui_str': 'Fluvoxamine'}]",[],,0.284539,This corrects the article on p. 102 in vol.,[],Infection & chemotherapy,['10.3947/ic.2022.0300']
2182,35706068,Evaluating the feasibility of a group psychosocial intervention for migrant and host community women in Ecuador and Panamá: protocol for a multi-site feasibility cluster trial.,"BACKGROUND


Community- and strengths-based psychosocial interventions are central to mental health and psychosocial support guidelines, but rigorous evidence regarding the effectiveness of these interventions is limited. The complexity and variability that is inherent to many community-based psychosocial interventions requires innovative strategies in order to facilitate the comparability and synthesis across research studies without compromising the fit and appropriateness of interventions to specific study populations and context. Entre Nosotras is a community-based psychosocial intervention developed for migrant and host community women that is designed to be flexible enough to enable integration of external intervention components and adaptable to diverse study contexts and populations. This protocol describes a study that aims to evaluate the appropriateness, acceptability, and feasibility of integrating a standardized stress management intervention into Entre Nosotras.
METHODS


This study will evaluate the appropriateness, acceptability, feasibility, and safety of intervention and research procedures for a cluster randomized comparative effectiveness trial conducted in Ecuador and Panamá with migrant and host community women. In this feasibility trial, we will allocate communities nested within the three study sites to the integrated Entre Nosotras + stress management intervention versus Entre Nosotras alone through stratified randomization. Migrant and host community women residing in these study communities who report low to moderate levels of distress will be allocated to the intervention condition that their community is assigned (n = 220 total). We will collect quantitative measures of psychosocial wellbeing, psychological distress, coping, social support, and functioning from study participants. We will collect quantitative measures of fidelity and facilitator competencies through observation and facilitator self-assessment. Data on appropriateness, acceptability, feasibility, and safety will be gathered from participants and facilitators through quantitative assessments at 0, 5, and 10 weeks post-enrollment and qualitative interviews conducted with all facilitators and a subset of 70 study participants during the post-intervention follow-up period.
DISCUSSION


Results from this feasibility trial will determine whether a multi-site cluster randomized comparative effectiveness trial of an adaptable community-based psychosocial intervention for migrant and host community women is relevant, acceptable, and feasible.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT05130944 . Registered November 23, 2021-retrospectively registered.",2022,Entre Nosotras is a community-based psychosocial intervention developed for migrant and host community women that is designed to be flexible enough to enable integration of external intervention components and adaptable to diverse study contexts and populations.,"['migrant and host community women in Ecuador and Panamá', 'Ecuador and Panamá with migrant and host community women']","['standardized stress management intervention', 'group psychosocial intervention', 'adaptable community-based psychosocial intervention', 'integrated Entre Nosotras + stress management intervention versus Entre Nosotras alone']","['acceptability, feasibility, and safety']","[{'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}]","[{'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0752247,Entre Nosotras is a community-based psychosocial intervention developed for migrant and host community women that is designed to be flexible enough to enable integration of external intervention components and adaptable to diverse study contexts and populations.,"[{'ForeName': 'M Claire', 'Initials': 'MC', 'LastName': 'Greene', 'Affiliation': 'Program on Forced Migration and Health, Heilbrunn Department of Population and Family Health, Columbia University Mailman School of Public Health, New York City, USA. Mg4069@cumc.columbia.edu.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Bonz', 'Affiliation': 'HIAS, Silver Spring, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cristobal', 'Affiliation': 'HIAS, Silver Spring, USA.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Vega', 'Affiliation': 'HIAS, Quito, Ecuador.'}, {'ForeName': 'Lena S', 'Initials': 'LS', 'LastName': 'Andersen', 'Affiliation': 'Global Health Section, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Angulo', 'Affiliation': 'HIAS, Panamá City, Panamá.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Armijos', 'Affiliation': 'HIAS, Quito, Ecuador.'}, {'ForeName': 'María Esther', 'Initials': 'ME', 'LastName': 'Guevara', 'Affiliation': 'HIAS, Quito, Ecuador.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Benavides', 'Affiliation': 'HIAS, Quito, Ecuador.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'de la Cruz', 'Affiliation': 'HIAS, Quito, Ecuador.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Lopez', 'Affiliation': 'HIAS, Quito, Ecuador.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Moyano', 'Affiliation': 'HIAS, Quito, Ecuador.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Murcia', 'Affiliation': 'HIAS, Panamá City, Panamá.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Noboa', 'Affiliation': 'HIAS, Quito, Ecuador.'}, {'ForeName': 'Abhimeleck', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'HIAS, Panamá City, Panamá.'}, {'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Solis', 'Affiliation': 'HIAS, Panamá City, Panamá.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Vergara', 'Affiliation': 'HIAS, Quito, Ecuador.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Scharf', 'Affiliation': 'Program on Forced Migration and Health, Heilbrunn Department of Population and Family Health, Columbia University Mailman School of Public Health, New York City, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Dutt', 'Affiliation': 'Program on Forced Migration and Health, Heilbrunn Department of Population and Family Health, Columbia University Mailman School of Public Health, New York City, USA.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Wainberg', 'Affiliation': 'Department of Psychiatry, Columbia University/New York State Psychiatric Institute, New York City, USA.'}, {'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Global Health Section, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",Pilot and feasibility studies,['10.1186/s40814-022-01085-1']
2183,35706643,"Comparison of two different volumes of 0.5%, ropivacaine used in ultrasound-guided adductor canal block after knee arthroplasty: A randomized, blinded, controlled noninferiority trial.","Background and Aims


The aim of this study was to establish noninferiority of 10 mL of 0.5% ropivacaine as compared to 20 mL of 0.5% ropivacaine; for choosing right dose in adductor canal block (ACB) after knee arthroplasty (KA), this trial was conducted.
Material and Methods


Forty patients undergoing bilateral KA with postoperative ultrasound-aided ACB were randomized: Group A patients received 20 mL 0.5% ropivacaine in the right limb and 10 mL 0.5% ropivacaine in the left limb. Group B patients received 10 mL of 0.5% ropivacaine in the right limb and 20 mL of 0.5% ropivacaine in the left limb. Catheter is positioned for intermittent boluses every 12-h up to 48 h.
Results


In the final analysis (excluding six patients) based on split-body design between Group I (comprising 34 limbs which received 20 mL of 0.5% ropivacaine) and Group II (comprising 34 limbs which received 10 mL of 0.5% ropivacaine), baseline demographic data were collected. Length of the limb from anterior superior iliac spine (ASIS) to the base of the patella was comparable between two groups: Group I (in cm; 149 ± 1.63) versus Group II (in cm; 149.5 ± 1.51) ( P  = 0.49, 95% CI of - 1.98 to 0.98). Primary outcomes, that is, quadriceps muscle strength, show a significant difference ( P  < 0.025) at various timeline. Secondary outcome pain scores and degree of knee flexion at various time intervals showed no significant difference. There was zero incidence of fall of the patient and no significant complication due to catheter was reported leading to discontinuation of catheter use in both groups.
Conclusion


10 mL of 0.5% ropivacaine is noninferior to 20 mL of 0.5% ropivacaine in providing postoperative analgesia with preserved quadriceps muscle strength.",2022,"There was zero incidence of fall of the patient and no significant complication due to catheter was reported leading to discontinuation of catheter use in both groups.
","['adductor canal block (ACB) after knee arthroplasty (KA', 'after knee arthroplasty', 'Forty patients undergoing bilateral KA with postoperative ultrasound-aided ACB']","['20 mL 0.5% ropivacaine in the right limb and 10 mL 0.5% ropivacaine', 'ultrasound-guided adductor canal block', '10 mL of 0.5% ropivacaine', 'ropivacaine']","['quadriceps muscle strength', 'Length of the limb from anterior superior iliac spine (ASIS', 'pain scores and degree of knee flexion at various time intervals']","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0223644', 'cui_str': 'Structure of anterior superior iliac spine'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",40.0,0.3478,"There was zero incidence of fall of the patient and no significant complication due to catheter was reported leading to discontinuation of catheter use in both groups.
","[{'ForeName': 'Nishith', 'Initials': 'N', 'LastName': 'Govil', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Sciences (AIIMS), Mangalagiri, Andhra Pradesh, India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Goyal', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Bharat B', 'Initials': 'BB', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Emergency Medicine, All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Vamshi', 'Initials': 'V', 'LastName': 'Krishna', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Arghya K', 'Initials': 'AK', 'LastName': 'Choudhury', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_112_20']
2184,35706639,Comparison of the effect of propofol and isoflurane on hemodynamic parameters and stress response hormones during Laparoscopic Cholecystectomy surgery.,"Background and Aims


General anesthesia induces endocrine, immunologic, and metabolic responses. Anesthetic drugs affect endocrine system by changing the level of stress hormones and hemodynamic of the patient . The purpose of this study was to compare the effects of propofol and isoflurane on hemodynamic parameters and stress-induced hormones in laparoscopic cholecystectomy (LC) surgery.
Material and Methods


Seventy patients of elective LC were included in this study. Patients were randomly divided into two equal groups of 35 patients; group  P  received propofol (70-120 μg/kg/min) and group I received isoflurane (mac: 1.28%) as anesthesia maintenance. The following parameters were monitored, checked, and recorded from preanesthesia period to 10 min after PACU entry according to a planned method: hemodynamic parameters (heart rate and mean atrial pressure), level of blood sugar, and serum epinephrine level.
Results


Heart rate and mean atrial pressure changes did not show significant differences between the two groups in all stage ( P  > 0.05), but isoflurane group tolerated lower fluctuating changes. Blood glucose and serum epinephrine level rise in the isoflurane group were significantly higher than the propofol group ( P  < 0.05).
Conclusion


Maintenance anesthesia by inhalation gas base on isoflurane has not shown a significant difference with total intravenous anesthesia base on propofol on hemodynamic parameter. However, propofol has a consistent effect on decreasing stress hormone and suggested for LC surgery.",2022,"Results


Heart rate and mean atrial pressure changes did not show significant differences between the two groups in all stage ( P  > 0.05), but isoflurane group tolerated lower fluctuating changes.","['Laparoscopic Cholecystectomy surgery', 'Material and Methods\n\n\nSeventy patients of elective LC']","['propofol and isoflurane', 'anesthesia maintenance', 'propofol', 'isoflurane', 'laparoscopic cholecystectomy (LC) surgery']","['hemodynamic parameters (heart rate and mean atrial pressure), level of blood sugar, and serum epinephrine level', 'Blood glucose and serum epinephrine level rise', 'Heart rate and mean atrial pressure changes', 'hemodynamic parameters and stress response hormones', 'hemodynamic parameters and stress-induced hormones']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C3854604', 'cui_str': 'Mean atrial pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1275466', 'cui_str': 'Serum epinephrine measurement'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.00675478,"Results


Heart rate and mean atrial pressure changes did not show significant differences between the two groups in all stage ( P  > 0.05), but isoflurane group tolerated lower fluctuating changes.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghomeishi', 'Affiliation': 'Pain Research Center, Imam Khomeini Hospital Research and Development Unit, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Mohtadi', 'Affiliation': 'Pain Research Center, Imam Khomeini Hospital Research and Development Unit, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Behaeen', 'Affiliation': 'Pain Research Center, Imam Khomeini Hospital Research and Development Unit, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Sholeh', 'Initials': 'S', 'LastName': 'Nesioonpour', 'Affiliation': 'Pain Research Center, Imam Khomeini Hospital Research and Development Unit, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Sheida Golbad', 'Affiliation': 'Pain Research Center, Imam Khomeini Hospital Research and Development Unit, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Bakhtiari', 'Affiliation': 'Pain Research Center, Imam Khomeini Hospital Research and Development Unit, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_146_19']
2185,35706616,A comparative study of sedo-analgesic effect of dexmedetomidine and dexmedetomidine with ketamine in postoperative mechanically ventilated patients.,"Background and Aims


To compare the sedoanalgesic effects of dexmedetomidine alone or with combination of ketamine.
Material and Methods


After getting ethical approval and informed patient consent, 60 adult surgical patients, were randomly divided into two groups. Group KD ( n  = 30); received dexmedotomidine 0.5 μg/kg/h mixed with ketamine 0.5 μg/kg/h and Group DEX ( n  = 30); received dexmedotomidine at 0.5 mg/kg/h infusion only. In both the groups, study drugs were titrated (dexmedetomidine- 0.2-0.7 μg/kg/h and ketamine 0.2-0.7 mg/kg/h) to achieve target sedation. Hemodynamic variables, pain scores, sedation scores, and patient satisfaction were recorded. Qualitative and Quantitative data were analyzed with Pearson Chi-squared test and analysis of variance test, respectively. All analyses were done by using statistical package for social sciences (SPSS) version 16.0.
Results


Pain scores were higher in group DEX than in group KD at 2 h and 4 h which was statistically significant ( P  < 0.05). At the end of 2 h, sedation scores were higher in group KD than in group DEX and was statistically significant ( P  < 0.05). Length of intensive care unit stay was almost comparable in both groups, and the time to tracheal extubation was lesser in ketamine-dexmedetomidine group as compared to the dexmedetomidine alone group. However the difference was statistically non-significant.
Conclusions


By combining dexmedetomidine with ketamine we observed lower incidence of hypotension and bradycardia. Dexmedetomidine with ketamine combination therapy could be used safely and effectively as sedo-analgesic agent.",2022,"Results


Pain scores were higher in group DEX than in group KD at 2 h and 4 h which was statistically significant ( P  < 0.05).","['postoperative mechanically ventilated patients', '60 adult surgical patients']","['dexmedetomidine and dexmedetomidine', 'DEX', 'ketamine combination therapy', 'dexmedotomidine', 'Dexmedetomidine', 'ketamine', 'dexmedotomidine 0.5 μg/kg/h mixed with ketamine 0.5 μg/kg/h and Group DEX', 'dexmedetomidine', 'ketamine-dexmedetomidine']","['Length of intensive care unit stay', 'Hemodynamic variables, pain scores, sedation scores, and patient satisfaction', 'time to tracheal extubation', 'hypotension and bradycardia', 'sedoanalgesic effects', 'Results\n\n\nPain scores', 'sedation scores']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",60.0,0.0587921,"Results


Pain scores were higher in group DEX than in group KD at 2 h and 4 h which was statistically significant ( P  < 0.05).","[{'ForeName': 'Bikram K', 'Initials': 'BK', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology, IMS, BHU, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Mhaske', 'Affiliation': 'Department of Obstetrics and Gynaecology, IMS, BHU, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Vishal Krishna', 'Initials': 'VK', 'LastName': 'Pai', 'Affiliation': 'Speciality Registrar, Department of Anaesthesiology, North Devon District Hospital, Barnstaple, Devon, England.'}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Mishra', 'Affiliation': 'Department of Anaesthesiology, IMS, BHU, Varanasi, Uttar Pradesh, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_234_19']
2186,35706596,"""They Eat What They Eat, I Eat What I Eat"": Examining the Perspectives and Experiences of African Americans Who Adopt Plant-Based Diets.","Adopting a plant-rich or plant-based diet is one of the major recommendations for addressing obesity, overweight, and related health conditions in the United States. Currently, research on African Americans' food choices in the context of plant-based diets is limited. The primary aim of this study was to understand food-related experiences and perceptions of African Americans who were participating in the Nutritious Eating with Soul (NEW Soul) study, a culturally tailored dietary intervention focused on increasing the consumption of plant-based foods. The roles of gender and ethnicity were also examined to identify how eating patterns were chosen or maintained. Twenty-one African American adults in South Carolina, who were randomly assigned to either a vegan diet (n = 11) or a low-fat omnivorous diet (n = 10) in the NEW Soul study, completed one-on-one, qualitative interviews. Emerging themes included awareness, being in control, and identity. The study revealed that access to social support and coping strategies for addressing negative comments about plant-based food choices may be important components to include in future nutrition interventions focused on African Americans.",2022,The study revealed that access to social support and coping strategies for addressing negative comments about plant-based food choices may be important components to include in future nutrition interventions focused on African Americans.,"['Twenty-one African American adults in South Carolina', 'African Americans', 'African Americans who were participating in the Nutritious Eating with Soul (NEW Soul) study, a']","['vegan diet', 'low-fat omnivorous diet', 'plant-rich or plant-based diet', 'culturally tailored dietary intervention']",[],"[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C5197846', 'cui_str': 'Diet, Plant-Based'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]",[],,0.0162082,The study revealed that access to social support and coping strategies for addressing negative comments about plant-based food choices may be important components to include in future nutrition interventions focused on African Americans.,"[{'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Botchway', 'Affiliation': 'Department of Health Promotion, Education, and Behavior (MB, GMTM, AC, MJW, MD, EAF).'}, {'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior (MB, GMTM, AC, MJW, MD, EAF).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Crimarco', 'Affiliation': 'Department of Health Promotion, Education, and Behavior (MB, GMTM, AC, MJW, MD, EAF).'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Wilson', 'Affiliation': 'Department of Health Promotion, Education, and Behavior (MB, GMTM, AC, MJW, MD, EAF).'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Davey', 'Affiliation': 'Department of Health Promotion, Education, and Behavior (MB, GMTM, AC, MJW, MD, EAF).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': 'Department of Health Promotion, Education, and Behavior (MB, GMTM, AC, MJW, MD, EAF).'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'Department of Health Promotion, Education, and Behavior (MB, GMTM, AC, MJW, MD, EAF).'}]",American journal of lifestyle medicine,['10.1177/1559827620908850']
2187,35706575,Optimal allocation of subjects in a matched pair cluster-randomized trial with fixed number of heterogeneous clusters.,"In cluster-randomized trials, investigators randomize clusters of individuals such as households, medical practices, schools or classrooms despite the unit of interest are the individuals. It results in the loss of efficiency in terms of the estimation of the unknown parameters as well as the power of the test for testing the treatment effects. To recoup this efficiency loss, some studies pair similar clusters and randomize treatment within pairs. However, the clusters within a treatment arm might be heterogeneous in nature. In this article, we propose a locally optimal design that accounts the clusters heterogeneity and optimally allocates the subjects within each cluster. To address the dependency of design on the unknown parameters, we also discuss Bayesian optimal designs. Performances of proposed designs are investigated numerically through some data examples.",2021,It results in the loss of efficiency in terms of the estimation of the unknown parameters as well as the power of the test for testing the treatment effects.,"['subjects in a matched pair cluster-randomized trial with fixed number of heterogeneous clusters', 'individuals such as households, medical practices, schools or classrooms despite the unit of interest are the individuals']",[],[],"[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",[],[],,0.0850575,It results in the loss of efficiency in terms of the estimation of the unknown parameters as well as the power of the test for testing the treatment effects.,"[{'ForeName': 'Satya Prakash', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Department of Mathematics, Indian Institute of Technology Hyderabad, Telangana, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Yadav', 'Affiliation': 'American Express Company, New York, United States.'}]",Journal of applied statistics,['10.1080/02664763.2020.1779195']
2188,35706523,The Effect of Shock Wave and Phonophoresis in the Improvement of the Clinical Symptoms and Function of Patients with Mild to Moderate Carpal Tunnel Syndrome: A Clinical Trial.,"Background:  Carpal tunnel syndrome is a common condition that causes pain, sensory and motor symptoms in the hands, especially in the thumb, index, and middle fingers due to the compression of the median nerve in the carpal tunnel. The purpose of this research was to investigate the effect of the shock wave and phonophoresis in the improvement of clinical symptoms and function of patients with mild to moderate carpal tunnel syndrome.  Methods:  The present research has employed a double-blind randomized clinical trial on 60 patients in Isfahan, Iran. Patients were randomly divided into 3 treatment groups of shock, phonophoresis, and control, and all patients received conservative treatments. Wrist thermoplastic splint, vitamin B1, and celecoxib were prescribed for all patients. The shock group received their intervention in four sessions of shock once a week for 4 weeks. Patients in the phonophoresis group received phonophoresis (pulse 1:4) 15 minutes every other day for 2 weeks. Pain scores were assessed based on the visual analog pain scale, and the Boston questionnaire severity scale was completed for each patient before, 1 and 2 months after the intervention. The used analytic tests included Fisher's exact tests, 1-way analysis of variance, and repeated measures analysis.  Results:  Shock wave and phonophoresis showed a significant decrease in pain, symptom severity index (p<0.001), and functional status (p<0.001). This reduction was more persistent in the phonophoresis group.  Conclusion:  The use of noninvasive shock wave and phonophoresis methods were good alternatives in the treatment of carpal tunnel syndrome.",2021,"Shock wave and phonophoresis showed a significant decrease in pain, symptom severity index (p<0.001), and functional status (p<0.001).","['Patients with Mild to Moderate Carpal Tunnel Syndrome', 'carpal tunnel syndrome', '60 patients in Isfahan, Iran', 'patients with mild to moderate carpal tunnel syndrome']","['shock, phonophoresis, and control, and all patients received conservative treatments', 'phonophoresis', 'Wrist thermoplastic splint, vitamin B1, and celecoxib', 'shock wave and phonophoresis', 'Shock Wave and Phonophoresis']","['pain, symptom severity index (p<0.001), and functional status', 'Pain scores', 'visual analog pain scale, and the Boston questionnaire severity scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0031582', 'cui_str': 'Phonophoresis therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",60.0,0.222326,"Shock wave and phonophoresis showed a significant decrease in pain, symptom severity index (p<0.001), and functional status (p<0.001).","[{'ForeName': 'Shila', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khosravi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Medical journal of the Islamic Republic of Iran,['10.47176/mjiri.35.179']
2189,35711607,Randomized Crossover Study of Auricular Plaster Therapy to Relieve Dental Anxiety in Children.,"Objective


To determine if auricular plaster therapy (APT) can alleviate dental anxiety in children aged 9 or 10 years old.
Methods


A crossover research was conducted on children with at least two deep-arrested deciduous molar caries ( N  = 80?). The first group ( N  = 40) received APT intended to reduce anxiety prior to the first caries treatment, whereas the second group ( N  = 40) received placebo/control APT (no anticipated impact on anxiety). The APT approaches were exchanged after a washout period following the initial caries treatment. Additionally, both groups were also informed and given a demonstration regarding the procedures and equipment prior to their use as part of a Tell-Show-Do (TSD) protocol. The dentists, children, and parents were all involved in assessing the level of anxiety using general anxiety scales. Moreover, the average heart rate and salivary cortisol concentration, both of which are indications of anxiety, were compared between the pre- and post-intervention periods. The participants were unaware of the type of APT that was employed (anti-anxiety vs. control). To avoid inadvertently influencing the outcome, all psychologists, investigators, and data recorders were blinded to the randomized subject sequence.
Results


Children treated with anti-anxiety APT demonstrated significantly higher levels of obedience than children treated with control APT ( P  < 0.05). In addition, children treated with APT had a lower average heart rate while awaiting treatment, undergoing local anesthesia, and receiving dental caries treatment ( P  < 0.05). These children had reduced salivary cortisol levels while awaiting treatment ( P  < 0.05).
Conclusion


Anti-anxiety APT can help relieve dental anxiety in children.",2022,"Results


Children treated with anti-anxiety APT demonstrated significantly higher levels of obedience than children treated with control APT ( P  < 0.05).","['children aged 9 or 10 years old', 'Children', 'children', 'children with at least two deep-arrested deciduous molar caries ( N  = 80']","['APT', 'auricular plaster therapy (APT', 'placebo/control APT', 'Auricular Plaster Therapy']","['Dental Anxiety', 'level of anxiety using general anxiety scales', 'levels of obedience', 'dental anxiety', 'average heart rate', 'salivary cortisol levels', 'average heart rate and salivary cortisol concentration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0335498,"Results


Children treated with anti-anxiety APT demonstrated significantly higher levels of obedience than children treated with control APT ( P  < 0.05).","[{'ForeName': 'Jiangtao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xi'an Union Hospital, Xi'an, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Central Laboratory, School of Public Health, Xinjiang Medical University, Ürümqi, China.'}, {'ForeName': 'Dalei', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Stomatology Center, The Affiliated Hospital of Hangzhou Normal University, Hangzhou, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2022.862575']
2190,35711604,Effect of Early Psychological Counseling for the Prevention of Posttraumatic Stress Induced by Acute Coronary Syndrome at Long-Term Follow-Up.,"Objective


Psychological consequences of myocardial infarction (MI) are substantial, as 4% of all MI patients develop posttraumatic stress disorder (PTSD) and 12% clinically relevant posttraumatic stress symptoms (PTSS). The study investigated the course and development within 12 months of MI-induced PTSS to gain novel insights in potentially delayed response to early trauma-focused counseling aimed at preventing the incidence of MI-induced PTSS.
Methods


In the MI-SPRINT two-group randomized controlled trial, 190 MI-patients were randomly allocated to receive a single-session intervention of either trauma-focused counseling or an active control intervention targeting the general role of stress in patients with heart disease. Blind interviewer-rated PTSS (primary outcome) and additional health outcomes were assessed at 12-month follow-up.
Results


12-month follow-up of outcomes were available for 106 (55.8%) of 190 participants: In the entire sample, one patient (0·5%, 1/190) who received trauma-focused counseling developed full PTSD. There was no significant difference between trauma-focused counseling and stress counseling regarding total score of interviewer-rated PTSS ( p  > 0.05). The only group difference emerged in terms of more severe hyperarousal symptoms in the trauma-focused counseling group in the ITT analysis, but not in the completer analysis.
Conclusions


No benefits were found for trauma-focused counseling after 12 months when compared with an active control intervention. PTSD prevalence in the present study was low highlighting a potential beneficial effect of both interventions. Further studies are needed to determine the most accurate approach of counseling.",2022,There was no significant difference between trauma-focused counseling and stress counseling regarding total score of interviewer-rated PTSS ( p  > 0.05).,"['patients with heart disease', 'MI patients develop posttraumatic stress disorder (PTSD) and 12% clinically relevant posttraumatic stress symptoms (PTSS', '190 participants: In the entire sample, one patient (0·5%, 1/190) who received trauma-focused counseling developed full PTSD', '190 MI-patients']","['MI-induced PTSS', 'Early Psychological Counseling', 'single-session intervention of either trauma-focused counseling or an active control intervention']","['additional health outcomes', 'severe hyperarousal symptoms', 'trauma-focused counseling and stress counseling regarding total score of interviewer-rated PTSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0474178', 'cui_str': 'Psychological counseling'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1276386', 'cui_str': 'Stress counseling'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]",190.0,0.0670096,There was no significant difference between trauma-focused counseling and stress counseling regarding total score of interviewer-rated PTSS ( p  > 0.05).,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Princip', 'Affiliation': 'Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Aju P', 'Initials': 'AP', 'LastName': 'Pazhenkottil', 'Affiliation': 'Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schnyder', 'Affiliation': 'Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hansjörg', 'Initials': 'H', 'LastName': 'Znoj', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Schmid', 'Affiliation': 'Department of Cardiology, Clinic Gais, Gais, Switzerland.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Langraf-Meister', 'Affiliation': 'Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'von Känel', 'Affiliation': 'Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Ledermann', 'Affiliation': 'Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2022.846397']
2191,35711602,"Intranasal Dexmedetomidine for the Treatment of Pre-operative Anxiety and Insomnia: A Prospective, Randomized, Controlled, and Clinical Trial.","Background and Objective


Several patients with pre-operative anxiety and insomnia refuse to take sleeping pills because of the side effects of sleeping pills. This study aimed to evaluate the applicability of intranasal dexmedetomidine (DEX) in the treatment of pre-operative anxiety and insomnia.
Methods


A total of 72 patients with insomnia and anxiety were randomly divided into two groups of intranasal DEX (n = 36) and intranasal normal saline (NS, n = 36). The primary outcomes included patients' time to fall asleep, total sleep time, insomnia severity index (ISI) after treatment, and satisfaction with the treatment effect. The secondary outcomes were mean arterial pressure (MAP), oxygen saturation (SPO 2 ), heart rate (HR), Narcotrend index (NI) in the first 2 h of treatment, and the incidence of adverse events within 12 h after treatment.
Results


The time to fall asleep (22.08 ± 3.95 min) and total sleep time (400.06 ± 28.84 min) in the DEX group were significantly different from those in the NS group [time to fall asleep, 89.31 ± 54.56 min; total sleep time (295.19 ± 73.51 min;  P  < 0.001)]. ISI after treatment in the DEX group was lower than that in the NS group ( P  < 0.001). Satisfaction with the treatment effect was better in the DEX group than that in the NS group ( P  < 0.001). The general vital signs in the two groups were stable during the treatment. The drowsiness rate in the NS group was higher than that in the DEX group ( P  < 0.001).
Conclusion


Intranasal DEX can significantly improve pre-operative anxiety and insomnia.
Clinical Trial Registration


This study was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/searchproj.aspx, ChiCTR2100044747).",2022,ISI after treatment in the DEX group was lower than that in the NS group ( P  < 0.001).,"['72 patients with insomnia and anxiety', 'Pre-operative Anxiety and Insomnia']","['intranasal DEX', 'intranasal normal saline', 'Intranasal Dexmedetomidine', 'DEX', 'intranasal dexmedetomidine (DEX']","['Satisfaction', 'mean arterial pressure (MAP), oxygen saturation (SPO 2 ), heart rate (HR), Narcotrend index (NI) in the first 2 h of treatment, and the incidence of adverse events', 'time to fall asleep', ""patients' time to fall asleep, total sleep time, insomnia severity index (ISI) after treatment, and satisfaction with the treatment effect"", 'pre-operative anxiety and insomnia', 'drowsiness rate', 'general vital signs', 'total sleep time', 'ISI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",72.0,0.0715866,ISI after treatment in the DEX group was lower than that in the NS group ( P  < 0.001).,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zeng', 'Affiliation': 'The First School of Clinical Medicine, Gannan Medical University, Ganzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'The First School of Clinical Medicine, Gannan Medical University, Ganzhou, China.'}, {'ForeName': 'Xujiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'The First School of Clinical Medicine, Gannan Medical University, Ganzhou, China.'}, {'ForeName': 'Kuan', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.'}, {'ForeName': 'Maolin', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.'}, {'ForeName': 'Shubao', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Zhan', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.'}, {'ForeName': 'Yulu', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Obstetrics and Gynecology, Luhe Hospital, Yingkou, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Anaesthesiology, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2022.816893']
2192,35711597,Efficacy of a Workplace Intervention Program With Web-Based Online and Offline Modalities for Improving Workers' Mental Health.,"Objective


This study aims to examine the efficacy of the Workplace Web-based blended psychoeducation mental health intervention program. Of particular interest is the short-term effect of the intervention on workplace burnout, stress, quality of life, and the mental health literacy of workers.
Methods and Materials


The study focused on employees ( n  = 456) in specific industries with high levels of work-related stress, adopting a phase III wait-listed cluster randomized controlled trial. Work-related burnout was assessed by the Maslach Burnout Inventory (MBI) and stress was measured using the stress subscale of the Depression, Anxiety, and Stress scale (DASS). Quality of Life was evaluated by the European Quality of Life-5 Dimensions (EQ-5D-5L) and Mental Health Literacy was assessed using the Australian National Mental Health Literacy and Stigma Survey. Data were analyzed as a trial with intention-to-treat analysis and adjustment for the clustering effect of work sites.
Results


Significant differences between intervention and control groups were found on all outcome measures except the self-rated quality of life. The intervention group displayed a significant reduction in the weighted mean score of about 1.0 units (s.e. = 0.4) on the stress scale ( p  = 0.015) and an increase in the weighted mean score of 1.9 units (s.e. = 0.9) in the professional accomplishment domain of the MBI ( p  = 0.035). Significant increases were found in the weighted mean scores in the intervention group for correct recognition of the mental problems, help-seeking, and stigmatization, in comparison to the control group who scored 0.2 (s.e. = 0.1), 0.9 (s.e. = 0.2), 1.8 (s.e. = 0.4), respectively.
Conclusions


The results obtained from a comparison of the outcome measures between the intervention and control groups were statistically significant, indicating that the intervention group performed better on most measures. The study demonstrates that, in the short term. the on-and-offline modalities of the Web-based blended psychoeducation intervention program is efficacious in reducing workplace burnout and stress and promoting mental health literacy at the workplace.",2022,"Significant increases were found in the weighted mean scores in the intervention group for correct recognition of the mental problems, help-seeking, and stigmatization, in comparison to the control group who scored 0.2 (s.e. = 0.1), 0.9 (s.e. = 0.2), 1.8 (s.e. = 0.4), respectively.
","[""Workers' Mental Health"", 'employees ( n  = 456) in specific industries with high levels of work-related stress, adopting a phase III wait-listed cluster randomized controlled trial']","['Workplace Web-based blended psychoeducation mental health intervention program', 'Web-based blended psychoeducation intervention program', 'Workplace Intervention Program With Web-Based Online and Offline Modalities']","['workplace burnout, stress, quality of life', 'stress subscale of the Depression, Anxiety, and Stress scale (DASS', 'Quality of Life', 'European Quality of Life-5 Dimensions (EQ-5D-5L) and Mental Health Literacy', 'Australian National Mental Health Literacy and Stigma Survey', 'correct recognition of the mental problems, help-seeking, and stigmatization', 'workplace burnout and stress and promoting mental health literacy', 'self-rated quality of life', 'weighted mean scores', 'weighted mean score', 'Maslach Burnout Inventory (MBI) and stress', 'stress scale']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0038330', 'cui_str': 'Stigmatization'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.011993,"Significant increases were found in the weighted mean scores in the intervention group for correct recognition of the mental problems, help-seeking, and stigmatization, in comparison to the control group who scored 0.2 (s.e. = 0.1), 0.9 (s.e. = 0.2), 1.8 (s.e. = 0.4), respectively.
","[{'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Lam', 'Affiliation': 'Eastern Health Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Lam', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, Australia.'}, {'ForeName': 'Prasuna', 'Initials': 'P', 'LastName': 'Reddy', 'Affiliation': 'Faculty of Science & Technology, Swinburne University of Technology, Melbourne, VIC, Australia.'}, {'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'The Mental Health Association Hong Kong, Kowloon, Hong Kong SAR, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2022.888157']
2193,35711483,"A prospective, randomized comparison of standard prone position versus flank-free modified supine position in percutaneous nephrolithotomy: A single-center initial experience.","Background


Percutaneous nephrolithotomy (PCNL) is the first choice for treatment of large renal stone >2 cm. The prone position is the classical position preferred by most surgeons. Aiming to improve patient anesthesia and surgery-related inconveniences of the prone position, Valdivia  et al ., 1987, described the performance of PCNL with the patient in the supine position. Hence, we aimed to study the safety and efficacy of flank-free modified supine position in PCNL compared to the standard prone position.
Patients and Methods


This is a prospective randomized study for 60 patients with large renal stones planned for PCNL operation during the period from November 2017 to May 2019. Patients were divided into two groups (30 patients each group): Group A - patients underwent PCNL in the prone position and Group B - patients underwent PCNL in the modified flank supine position. Patients' demographics, stone size, Hounsfield unit with intraoperative details as fluoroscopy time, operative time, and complications were recorded. Postoperatively, need for or not to blood transfusions, hospital stay, stone-free status, and postoperative complications were assessed.
Results


There was no statistically significant difference between the prone and supine positions regarding stone size (4 cm vs. 4.5 cm,  P  = 0.16), Hounsfield unit (940 HU vs. 955 HU,  P  = 0.78), body mass index (31.2 kg/m 2  vs. 32.5 kg/m 2 ,  P  = 0.49), fluoroscopy time (6.9 min vs. 7.3 min,  P  = 0.5), operative time (89.5 min vs. 90.4 min,  P  = 0.9), residual stones (10% vs. 20%,  P  = 0.8), and hospital stay (45.6 h vs. 48.6 h,  P  = 0.5). Fever occurred in 3.3% of cases in each group and urine leakage observed in one patient with prone position. No blood transfusion was needed in both the groups.
Conclusions


PCNL in the modified supine position proved to be a safe and effective choice compared to the prone position for adult patients with large renal calculi.",2022,"There was no statistically significant difference between the prone and supine positions regarding stone size (4 cm vs. 4.5 cm,  P  = 0.16), Hounsfield unit (940 HU vs. 955 HU,  P  = 0.78), body mass index (31.2 kg/m 2  vs. 32.5 kg/m 2 ,  P  = 0.49), fluoroscopy time (6.9 min vs. 7.3 min,  P  = 0.5), operative time (89.5 min vs. 90.4 min,  P  = 0.9), residual stones (10% vs. 20%,  P  = 0.8), and hospital stay (45.6 h vs. 48.6 h,  P  = 0.5).","['60 patients with large renal stones planned for PCNL operation during the period from November 2017 to May 2019', 'adult patients with large renal calculi', 'Patients were divided into two groups (30 patients each group']","['\n\n\nPercutaneous nephrolithotomy (PCNL', 'standard prone position versus flank-free modified supine position', 'percutaneous nephrolithotomy', 'PCNL', 'flank-free modified supine position']","['body mass index', ""Patients' demographics, stone size, Hounsfield unit with intraoperative details as fluoroscopy time, operative time, and complications"", 'operative time', 'blood transfusion', 'urine leakage', 'hospital stay', 'fluoroscopy time', 'Postoperatively, need for or not to blood transfusions, hospital stay, stone-free status, and postoperative complications', 'residual stones', 'prone and supine positions regarding stone size', 'Fever']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",60.0,0.0102655,"There was no statistically significant difference between the prone and supine positions regarding stone size (4 cm vs. 4.5 cm,  P  = 0.16), Hounsfield unit (940 HU vs. 955 HU,  P  = 0.78), body mass index (31.2 kg/m 2  vs. 32.5 kg/m 2 ,  P  = 0.49), fluoroscopy time (6.9 min vs. 7.3 min,  P  = 0.5), operative time (89.5 min vs. 90.4 min,  P  = 0.9), residual stones (10% vs. 20%,  P  = 0.8), and hospital stay (45.6 h vs. 48.6 h,  P  = 0.5).","[{'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Zanaty', 'Affiliation': 'Department of Urology, Faculty of Medicine, Menoufia University, Menofia, Damanhour, Egypt.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Mousa', 'Affiliation': 'Department of Urology, National Medical Institute, Damanhour, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elgharabawy', 'Affiliation': 'Department of Urology, Faculty of Medicine, Menoufia University, Menofia, Damanhour, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elshazly', 'Affiliation': 'Department of Urology, Faculty of Medicine, Menoufia University, Menofia, Damanhour, Egypt.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Sultan', 'Affiliation': 'Department of Urology, Faculty of Medicine, Menoufia University, Menofia, Damanhour, Egypt.'}]",Urology annals,['10.4103/UA.UA_31_20']
2194,35711903,Study on Low-Frequency Repetitive Transcranial Magnetic Stimulation Improves Speech Function and Mechanism in Patients With Non-fluent Aphasia After Stroke.,"Objective


To explore the therapeutic effect and mechanism of low-frequency repetitive transcranial magnetic stimulation on the speech function of patients with non-fluent aphasia after stroke.
Methods


According to the inclusion and exclusion criteria, 60 patients with post-stroke non-fluent aphasia were included and randomly divided into treatment group (rTMS group) and sham stimulation group (S-rTMS group). Patients in rTMS group were given low-frequency rTMS + ST training. Patients in the S-rTMS group were given sham low-frequency rTMS + ST training. Once a day, 5 days a week, for a total of 4 weeks. The Western Aphasia Battery and the short-form Token test were used to evaluate the language function of the patients in the two groups before and after treatment. Part of the enrolled patients were subjected to functional magnetic resonance imaging examination, and the morning fasting venous blood of the enrolled patients was drawn before and after treatment to determine the content of BDNF and TNF-α.
Results


In the comparison before and after treatment within the group, all dimensions of the WAB scale of the patients in the rTMS group increased significantly. Only two dimensions of the WAB scale of the patients in the S-rTMS group improved significantly after treatment. The results of the short-form Token test showed that patients in the rTMS group improved significantly before and after treatment. The resting state functional magnetic resonance imaging of the two groups of patients before and after treatment showed: the activation of multiple brain regions in the left hemisphere of the rTMS group increased compared with the control group. The serum BDNF content of the patients in the rTMS group was significantly higher than that of the patients in the S-rTMS group after treatment.
Conclusion


Low-frequency rTMS combined with conventional speech training can significantly improve the speech function of patients with non-fluent aphasia after stroke.",2022,The results of the short-form Token test showed that patients in the rTMS group improved significantly before and after treatment.,"['Patients With Non-fluent Aphasia After Stroke', 'patients with non-fluent aphasia after stroke', '60 patients with post-stroke non-fluent aphasia']","['functional magnetic resonance imaging examination', 'low-frequency rTMS + ST training', 'conventional speech training', 'rTMS', 'low-frequency repetitive transcranial magnetic stimulation', 'Low-Frequency Repetitive Transcranial Magnetic Stimulation', 'sham low-frequency rTMS + ST training', 'treatment group (rTMS group) and sham stimulation group (S-rTMS']","['activation of multiple brain regions', 'WAB scale', 'speech function', 'serum BDNF content', 'resting state functional magnetic resonance imaging', 'language function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349390', 'cui_str': 'Non-fluent aphasia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0419144', 'cui_str': 'Speech training'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",60.0,0.00826396,The results of the short-form Token test showed that patients in the rTMS group improved significantly before and after treatment.,"[{'ForeName': 'Guangtao', 'Initials': 'G', 'LastName': 'Bai', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': ""Department of Otolaryngology, Qingdao Women's and Children's Hospital, Qingdao, China.""}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Huan', 'Affiliation': ""Department of Rehabilitation Medicine, Qingdao Women's and Children's Hospital, Qingdao, China.""}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Meng', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, China.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2022.883542']
2195,35711854,Students' Perceptions of Learning Life Skills Through the Teaching Personal and Social Responsibility Model: An Exploratory Study.,"Purpose


Physical education (PE) lags behind community-based sport and physical activity programs in the integration of positive youth development (PYD) principles and practices such as teaching transferable life skills. However, research and educational policy indicates this can and should be part of the PE curriculum. Therefore, there is a significant need to explore students' perceptions and experiences about learning life skills within the PE context. In the current study, an intervention based in a wellestablished PYD approach called Teaching Personal and Social Responsibility (TPSR), was delivered to assess these issues.
Methods


The current study was conducted in the mid-western U.S. Participants were 122 adolescent students (m = 60, f = 62;  M  = 12.48 years, SD = 0.97 years) in intervention and control classes. For the intervention, a PE teacher received training on the TPSR approach to promote life skills, while the control teacher received no training and participated in usual practices. Pre- and post-surveys were distributed that examined student perceptions about learning life skills, and supplemental systematic observations were recorded to capture the intervention teacher's fidelity to the TPSR model.
Results


Results indicated that the intervention group students' perceptions of in-class experiences with life skills such as problem solving, emotional regulation, effort, goal setting, identity experiences, time management, and promoting social norms were enhanced overtime, compared to the control group.
Conclusion


PE is in a unique position to promote PYD in the school curriculum by teaching of life skills. In this case, participants in the intervention group demonstrated learning personally and socially responsible behaviors across the course of 15 PE lessons. Future research should examine if changed in-class perceptions about life skills can foster use of these skills outside of the PE setting.",2022,"Results


Results indicated that the intervention group students' perceptions of in-class experiences with life skills such as problem solving, emotional regulation, effort, goal setting, identity experiences, time management, and promoting social norms were enhanced overtime, compared to the control group.
","['mid-western U.S. Participants were 122 adolescent students (m = 60, f = 62;  M  = 12.48 years, SD = 0.97 years) in intervention and control classes']",['Physical education (PE) lags behind community-based sport and physical activity programs'],"[' perceptions of in-class experiences with life skills such as problem solving, emotional regulation, effort, goal setting, identity experiences, time management, and promoting social norms', 'learning personally and socially responsible behaviors']","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",122.0,0.0205029,"Results


Results indicated that the intervention group students' perceptions of in-class experiences with life skills such as problem solving, emotional regulation, effort, goal setting, identity experiences, time management, and promoting social norms were enhanced overtime, compared to the control group.
","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL, United States.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Wright', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL, United States.'}, {'ForeName': 'K Andrew R', 'Initials': 'KAR', 'LastName': 'Richards', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, United States.'}]",Frontiers in sports and active living,['10.3389/fspor.2022.898738']
2196,35711820,Effectiveness of anabolic steroids in improving outcomes for post-operative hip fracture patients: A randomized controlled trial.,"Background


Post-operative elderly hip fracture patients require significant rehabilitation. Nandrolone is an anabolic steroid used to promote muscle growth. This study aims to examine the effect of nandrolone in improving rehabilitation and quality of life in elderly female patients with hip fractures undergoing hemiarthroplasty.
Methods


This is a double-blinded prospective randomized-controlled-trial consisting of female patients above the age of 65 with an isolated neck of femur fracture planned for a hip hemiarthroplasty. Participants were randomized into two arms of the study - 50 mg intramuscular nandrolone vs normal saline placebo administered on post-operative day 0, and weeks 2, 6 and 12. The participants were followed up across a 1-year period following the surgery. Clinical outcomes such as time taken to achieve rehabilitation milestones, distance of ambulation and thigh muscle girth, and functional scoring with SF-36 questionnaire were recorded at intervals of 2, 6 and 12 weeks, 6 months and 1 year following the surgery.
Results


There were a total of 23 subjects with 11 in the steroid group and 12 in the placebo group. There was no significant difference in demographics and injury patterns between both groups. There was no significant difference for time taken to achieve various rehabilitation milestones and distance of ambulation. SF-36 scores on discharge and at 1-year follow-up mark were comparable. There was no difference in the complication rate between both groups.
Conclusion


Intra-muscular Nandrolone after hip surgery in elderly female patients does not result in short to mid-term improved rehabilitation or functional outcomes. Nandrolone did not result in increased short-term complications after hip surgery.
Level of evidence


I.",2022,"There was no difference in the complication rate between both groups.
","['elderly female patients', '23 subjects with 11 in the steroid group and 12 in the placebo group', 'female patients above the age of 65 with an isolated neck of femur fracture planned for a hip hemiarthroplasty', 'post-operative hip fracture patients', 'elderly hip fracture patients', 'elderly female patients with hip fractures undergoing hemiarthroplasty']","['Conclusion\n\n\nIntra-muscular Nandrolone', 'nandrolone', 'anabolic steroids', 'Nandrolone', 'nandrolone vs normal saline placebo']","['time taken to achieve rehabilitation milestones, distance of ambulation and thigh muscle girth, and functional scoring with SF-36 questionnaire', 'time taken to achieve various rehabilitation milestones and distance of ambulation', 'SF-36 scores', 'short-term complications', 'complication rate', 'rehabilitation and quality of life', 'demographics and injury patterns']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1112760', 'cui_str': 'Hip hemiarthroplasty'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0027368', 'cui_str': 'Nandrolone'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",23.0,0.211787,"There was no difference in the complication rate between both groups.
","[{'ForeName': 'Michael Gui Jie', 'Initials': 'MGJ', 'LastName': 'Yam', 'Affiliation': 'Department of Orthopaedic Surgery, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Pirateb', 'Initials': 'P', 'LastName': 'Paramasivam Meenakshi Sundaram', 'Affiliation': 'Department of Orthopaedic Surgery, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Sean Wei Loong', 'Initials': 'SWL', 'LastName': 'Ho', 'Affiliation': 'Department of Orthopaedic Surgery, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Ernest Beng Kee', 'Initials': 'EBK', 'LastName': 'Kwek', 'Affiliation': 'Department of Orthopaedic Surgery, Woodlands Health, Singapore.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2022.101913']
2197,35711722,Prospective comparative analysis of efficacy of local debridement with or without vancomycin impregnated calcium sulphate in chronic osteomyelitis.,"The primary objective of this study was to compare the efficacy of use of Vancomycin impregnated bioabsorbable calcium sulphate (VCS) pellets along with surgical debridement to control group without the use of calcium sulphate for chronic osteomyelitis. The secondary objective was comparing the results in different subtypes of chronic osteomyelitis.
Methods


50 consecutive patients were enrolled in VCS group and control group based on used whether VCS was used in treatment in addition to surgical debridement or not. Patients were classified using Cerny Mader Classification and were serially followed up to compare efficacy of eradication of infection and complications between the groups.
Results


Patients were followed for a minimum of 24 months postoperatively (range, 24-63 months; mean 32.2 ± 4.2months). 88% (44/50) of patients in VCS group achieved eradication of infection when compared to 64% (32/50) in control group at 2-year follow-up period (p < 0.001). Three out of six patient with recurrence in VCS group and 11 out 18 patients in control group achieved eradication after second stage surgery using same protocol using VCS. Among 10 with persistent infection, 5 among these were those with diffuse osteomyelitis and 5 were those with medullary osteomyelitis. In VCS group, 18/50 patients had persistent serous drainage from the wound for up to 4 weeks which was self-limiting.
Conclusion


Local debridement combined with antibiotic impregnated calcium sulphate as a single-stage treatment is effective in treating chronic localized osteomyelitis when compared to debridement alone. However, its use alone in diffuse osteomyelitis may be less effective.",2022,Three out of six patient with recurrence in VCS group and 11 out 18 patients in control group achieved eradication after second stage surgery using same protocol using VCS.,"['chronic osteomyelitis', '50 consecutive patients were enrolled in VCS group and control group based on used whether']","['calcium sulphate', 'antibiotic impregnated calcium sulphate', 'Vancomycin impregnated bioabsorbable calcium sulphate (VCS', 'VCS', 'local debridement with or without vancomycin impregnated calcium sulphate']","['persistent serous drainage', 'eradication of infection', 'efficacy of eradication of infection and complications']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.0373857,Three out of six patient with recurrence in VCS group and 11 out 18 patients in control group achieved eradication after second stage surgery using same protocol using VCS.,"[{'ForeName': 'Nuthan', 'Initials': 'N', 'LastName': 'Jagadeesh', 'Affiliation': 'Department of Orthopedics, Vydehi Institute of Medical Sciences, Whitefield, Bangalore, Karnataka, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Abdul', 'Affiliation': 'Department of Orthopedics, Vydehi Institute of Medical Sciences, Whitefield, Bangalore, Karnataka, India.'}, {'ForeName': 'Vishwanath M', 'Initials': 'VM', 'LastName': 'Shivalingappa', 'Affiliation': 'Department of Orthopedics, Vydehi Institute of Medical Sciences, Whitefield, Bangalore, Karnataka, India.'}, {'ForeName': 'Hiranya', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopedics, Vydehi Institute of Medical Sciences, Whitefield, Bangalore, Karnataka, India.'}]",Journal of orthopaedics,['10.1016/j.jor.2022.06.002']
2198,35712162,A Positive Psychology Resource for Students? Evaluation of the Effectiveness of the 6 Minutes Diary in a Randomized Control Trial.,"This study investigated the effects of the 6 Minutes Journal (6MT), a commercial diary combining several positive psychology interventions, including gratitude, goal-setting, and self-affirmation exercises, on several mental health outcome measures. In a randomized controlled trial, university students ( N  = 157) were randomly assigned to one of two groups: 6MT ( n  = 77) and a wait list control group ( n  = 80). Participants in the intervention group were instructed to follow the instructions of the 6MT for 4 weeks. Participants in both groups completed measures of perceived stress, positive and negative affect, self-efficacy and resilience at baseline, after 2 (t1), and 4 (t2) weeks. We used path-analyses with autoregressive and cross-lagged effects to test our hypotheses of the effects of the 6MT. Participants in the intervention group reported decreased levels of perceived stress and negative affect, as well as increased levels of resilience and self-efficacy compared to the control group. Positive affect was not statistically significantly influenced. The data showed a statistically significant increased levels of self-efficacy and resilience only after 4 weeks, suggesting that changing these constructs needs more time. The 6-minute diary does not appear to make individuals fundamentally more positive. However, the intervention may have a protective function against negative influences on well-being.",2022,"Participants in the intervention group reported decreased levels of perceived stress and negative affect, as well as increased levels of resilience and self-efficacy compared to the control group.",['university students ( N  = 157'],"['6MT', '6 Minutes Journal (6MT', 'wait list control group']","['levels of resilience and self-efficacy', 'levels of self-efficacy and resilience', 'levels of perceived stress and negative affect', 'perceived stress, positive and negative affect, self-efficacy and resilience']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",157.0,0.0356992,"Participants in the intervention group reported decreased levels of perceived stress and negative affect, as well as increased levels of resilience and self-efficacy compared to the control group.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Lorenz', 'Affiliation': 'Department of Psychology, Medical School Berlin (MSB), Berlin, Germany.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Algner', 'Affiliation': 'Department of Psychology, Medical School Berlin (MSB), Berlin, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Binder', 'Affiliation': 'Department of Psychology, Medical School Berlin (MSB), Berlin, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2022.896741']
2199,35712141,Executive Functions and Mood States in Athletes Performing Exercise Under Hypoxia.,"Hypoxia can impair cognitive performance, whereas exercise can enhance it. The effects of hypoxia on cognitive performance during exercise appear to be moderated by exercise duration and intensity and by severity and duration of hypoxia and cognitive task. In normal individuals, exercise under hypoxia can evoke adverse post-exercise mood states, such as tension and fatigue. However, little is known about the effects of hypoxia during exercise in trained athletes. The purpose of this study was to investigate how hypoxia affected executive functions and mood states, assessed, respectively, during and post-exercise and to explore the role of motivation moderators, such as inhibition and activation systems (BIS-BAS). Two different sessions of exercise in normoxia and hypoxia (FiO2 13%), each lasting 18 min, were randomly assigned in a counterbalanced order and administered to seventeen male athletes. During exercise bouts, participants performed a mental task (BST) aimed to produce cognitive interference and suppression. Reaction times and accuracy of responses were recorded. After 5 min, all participants completed two questionnaires assessing mood states (ITAMS) and incidence of symptoms potentially related to hypoxia (AMS-C). The results show that hypoxia impairs cognitive performance in terms of slower reaction times, but a high BAS attenuates this effect. Participants with high BAS show an equivalent cognitive performance under hypoxia and normoxia conditions. No effects were found on mood states. Further research is required to investigate the role of BAS, cognitive abilities, and mood states in prolonged hypoxic conditions.",2022,"After 5 min, all participants completed two questionnaires assessing mood states (ITAMS) and incidence of symptoms potentially related to hypoxia (AMS-C).","['Athletes Performing Exercise Under Hypoxia', 'Participants with high BAS show an equivalent cognitive performance under hypoxia and normoxia conditions', 'trained athletes', 'seventeen male athletes']",['mental task (BST'],"['mood states', 'Reaction times and accuracy of responses', 'exercise duration and intensity and by severity and duration of hypoxia and cognitive task', 'cognitive performance', 'Executive Functions and Mood States', 'questionnaires assessing mood states (ITAMS) and incidence of symptoms potentially related to hypoxia (AMS-C']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}]",17.0,0.0148553,"After 5 min, all participants completed two questionnaires assessing mood states (ITAMS) and incidence of symptoms potentially related to hypoxia (AMS-C).","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guicciardi', 'Affiliation': 'Department of Education, Psychology, Philosophy, Faculty of Humanities, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pazzona', 'Affiliation': 'Department of Education, Psychology, Philosophy, Faculty of Humanities, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Manca', 'Affiliation': 'Department of Education, Psychology, Philosophy, Faculty of Humanities, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Monni', 'Affiliation': 'Department of Education, Psychology, Philosophy, Faculty of Humanities, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Laura Francesca', 'Initials': 'LF', 'LastName': 'Scalas', 'Affiliation': 'Department of Education, Psychology, Philosophy, Faculty of Humanities, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Perra', 'Affiliation': 'Department of Education, Psychology, Philosophy, Faculty of Humanities, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Leban', 'Affiliation': 'Department of Mechanical, Chemical and Materials Engineering, Faculty of Engineering and Architecture, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Roberto', 'Affiliation': 'Sports Physiology Lab, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Mulliri', 'Affiliation': 'Sports Physiology Lab, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Ghiani', 'Affiliation': 'Sports Physiology Lab, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Doneddu', 'Affiliation': 'Sports Physiology Lab, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Crisafulli', 'Affiliation': 'Sports Physiology Lab, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}]",Frontiers in psychology,['10.3389/fpsyg.2022.906336']
2200,35709198,Digital teaching tools in sports medicine: A randomized control trial comparing the effectiveness of virtual seminar and virtual fishbowl teaching method in medical students.,"BACKGROUND


Since the COVID-19 pandemic, the demand for online courses has increased enormously. Therefore, finding new methods to improve medical education is imperative.
OBJECTIVE


The aim of this study was to compare the self-reports of the individual student-centered virtual teaching techniques (seminar versus fishbowl) in a group of medical students.
METHODS


During the second semester of 2020, students in the clinical phase of the study (n = 144) participated in the optional subject of Sports Medicine. The students were divided into 2 groups. One group (n = 72) received the knowledge transfer in the form of a virtual seminar, the other group (n = 72) in the form of a virtual fishbowl.
RESULTS


Virtual seminar and virtual fishbowl students gave insights into these teaching techniques. Most of the students from the virtual fishbowl group believed that the virtual fishbowl format allowed them to be more actively involved in learning. The mean quiz scores were statistically higher for students in the virtual fishbowl group than students in the virtual seminar group (p < 0. 001).
CONCLUSION


This study concluded that virtual seminars and virtual fishbowl formats could be served as structured learning and teaching formats. At the same time, the virtual fishbowl format can promote an active exchange of knowledge from students' perspectives.",2022,"The mean quiz scores were statistically higher for students in the virtual fishbowl group than students in the virtual seminar group (p < 0. 001).
","['a group of medical students', 'During the second semester of 2020, students in the clinical phase of the study (n = 144) participated in the optional subject of Sports Medicine', 'medical students', 'sports medicine']","['virtual seminar and virtual fishbowl teaching method', 'individual student-centered virtual teaching techniques (seminar versus fishbowl']",['mean quiz scores'],"[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}]","[{'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",144.0,0.0391507,"The mean quiz scores were statistically higher for students in the virtual fishbowl group than students in the virtual seminar group (p < 0. 001).
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hertling', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Hertling', 'Affiliation': 'Department of Gynecology, Hospital Rummelsberg, Schwarzenbruck, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Matziolis', 'Affiliation': 'Orthopaedic Department, Campus Eisenberg, University Hospital Jena, Jena, Eisenberg, Germany.'}, {'ForeName': 'Ekkehard', 'Initials': 'E', 'LastName': 'Schleußner', 'Affiliation': 'Department of Obstetrics, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Loos', 'Affiliation': 'Practice for Orthopaedics and Shoulder Surgery, Leipzig, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Graul', 'Affiliation': 'Orthopaedic Department, Campus Eisenberg, University Hospital Jena, Jena, Eisenberg, Germany.'}]",PloS one,['10.1371/journal.pone.0267144']
2201,35709172,Ability and accuracy of the smartphone-based O`VIEW-M® sperm test: Useful tool in the era of Covid-19.,"Male infertility affects up to 12% of men. Although manual testing using microscope examination and computer-assisted semen analysis are standard methods of measuring sperm count and motility, these methods are limited by being laboratory based. To investigate the usefulness of a novel semen analysis device using a smartphone camera. This prospective multicenter randomized parallel design trial enrolled 200 men aged ≥19 years of age between August and December 2018. Each subject was advised to use the Smart Sperm Test for OVIEW-M at home after 5 days of abstinence. The accuracy of the OVIEW-M test relative to the in-hospital test was determined. A questionnaire was administered to assess subject likelihood of using the OVIEW-M. Measurements using standard methods and the OVIEW-M showed similar sperm counts and similar motile sperm counts. Correlation analysis showed significant correlations between sperm count and sperm motility when measured by OVIEW-M tests (r = 0.893, p < 0.01) and standard microscope examination (r = 0.883, p < 0.01). Of the subjects who responded to questionnaires, 43% regarded the results of the OVIEW-M tests as reliable and 18% as unreliable. Semen analysis with the smartphone-based application and accessories yielded results not inferior to those of laboratory tests. Men who visit the hospital for evaluation of infertility can easily perform OVIEW-M semen tests at home.",2022,"Correlation analysis showed significant correlations between sperm count and sperm motility when measured by OVIEW-M tests (r = 0.893, p < 0.01) and standard microscope examination (r = 0.883, p < 0.01).",['200 men aged ≥19 years of age between August and December 2018'],"['smartphone-based O`VIEW-M® sperm test', 'smartphone camera']","['standard microscope examination', 'sperm count and sperm motility']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037842', 'cui_str': 'Sperm count'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}]",200.0,0.0573828,"Correlation analysis showed significant correlations between sperm count and sperm motility when measured by OVIEW-M tests (r = 0.893, p < 0.01) and standard microscope examination (r = 0.883, p < 0.01).","[{'ForeName': 'Kyu Shik', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Medical and Digital Engineering, Hanyang University, Seoul, Korea.'}, {'ForeName': 'Ji Hyoung', 'Initials': 'JH', 'LastName': 'Roh', 'Affiliation': 'Medical Device Development Center, Daegu-Gyeonbuk Medical Innovation Foundation, Daegu, Korea.'}, {'ForeName': 'Daegwan', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Medical Device Development Center, Daegu-Gyeonbuk Medical Innovation Foundation, Daegu, Korea.'}, {'ForeName': 'Hyang Mi', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'LG Sciencepark AI, Seoul, Korea.'}, {'ForeName': 'Jung Ki', 'Initials': 'JK', 'LastName': 'Jo', 'Affiliation': 'Department of Urology, Hanyang University College of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0269894']
2202,34870387,"Accommodating variable-resistance exercise enhance weight-bearing/gait symmetry and balance capability in children with hemiparetic cerebral palsy: a parallel-group, single-blinded randomized clinical trial.","BACKGROUND


Children with hemiparetic cerebral palsy (HCP) tend preferentially to bear their body weight on the non-paretic side, which leads to the emergence of asymmetrical walking patterns and limited ability to maintain balance. Therefore, improved and clearly effective intervention strategies to remedy these impairments are needed.
AIM


This study endeavored to evaluate the efficacy of an accommodating variable-resistance exercise (AVr-Ex) program on weight-bearing symmetry, gait symmetry, and dynamic balance in children with HCP.
DESIGN


This study employed a parallel-group, single-blinded randomized controlled design.
SETTINGS


Physical Therapy Outpatient Clinic and University Hospital, and a tertiary referral hospital.
POPULATION


Thirty-six children with HCP aged between eight and 16 years were assigned randomly to the AVr-Ex group (N.=18) or control group (N.=18).
METHODS


Children in the AVr-Ex group undergone an AVr-Ex program, three sessions/week over eight consecutive weeks, besides the usual physical therapy while children in the Control group received the usual physical therapy alone. Outcome measures were evaluated before and after intervention and included weight-bearing symmetry indices [rearfoot (RF-WbSI), and forefoot (FF-WbSI)], gait symmetry indices (spatial [GSI<inf>spatial</inf>], and temporal [GSI<inf>temporal</inf>]), and dynamic balance.
RESULTS


The post-treatment RF-WbSI (P<0.001; η<inf>p</inf> 2 =0.41), GSI<inf>spatial</inf> (P<0.001; η<inf>p</inf> 2 =0.42), GSI<inf>temporal</inf> (P<0.001; η<inf>p</inf> 2 =0.52), and dynamic balance variables (all P<0.05; η<inf>p</inf> 2  ranged from 0.21 to 0.51) improved significantly in the AVr-Ex group compared to the control group, when controlled for the pre-treatment scores.
CONCLUSIONS


This study suggests that AVr-Ex can improve weight-bearing symmetry, gait symmetry, and dynamic balance in children with HCP when incorporated into the usual physical rehabilitation program.
CLINICAL REHABILITATION IMPACT


AVr-Ex is likely an effective training paradigm to address weight-bearing/gait asymmetry and balance issues in children with HCP, which provides the basis for its incorporation in rehabilitation programs for such a patient population.",2022,The post-treatment RF-WbSI (P<0.001;,"['Children in the AVr-Ex group undergone an', 'Children with hemiparetic cerebral palsy (HCP', 'children with HCP', 'Physical Therapy Outpatient Clinic and University Hospital, and a tertiary referral hospital', 'children with hemiparetic cerebral palsy', 'Thirty-six children with HCP aged between eight and 16 years']","['AVr-Ex program', 'usual physical therapy while children in the Control group received the usual physical therapy alone', 'Accommodating variable-resistance exercise enhance weight-bearing/gait symmetry', 'accommodating variable-resistance exercise (AVr-Ex) program']","['weight-bearing symmetry, gait symmetry, and dynamic balance', 'dynamic balance variables', 'weight-bearing symmetry indices [rearfoot (RF-WbSI), and forefoot (FF-WbSI)], gait symmetry indices (spatial [GSI<inf>spatial</inf>], and temporal [GSI<inf>temporal</inf>]), and dynamic balance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]","[{'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",36.0,0.0382999,The post-treatment RF-WbSI (P<0.001;,"[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, Collage of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia - rke_pt2001@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Alhowimel', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, Collage of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Mazyad', 'Initials': 'M', 'LastName': 'Alotaibi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, Collage of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Abdrabo', 'Affiliation': 'Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Elshafey', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.21.07324-X']
2203,35685985,Assessment of Quality of Life for Scheuermann's Kyphosis Patients with Cobb's Angle 50°-65° Treated Conservatively or Surgically in North Jordan: A Prospective Comparative Study.,"Background


Scheuermann's disease is the most common cause of hyperkyphosis of the thoracic spine during the adolescence period. It causes neck and lower back pain, restriction of lung expansion, traction of the spinal cord, increased vulnerability to vertebral fracture, and a hump. Patients with curves < 60° are treated conservatively, while surgery is used for patients with curves > 60°. The purpose of this prospective cohort study was to assess the quality of life and functional changes in conservatively or surgically treated Scheuermann's disease patients with a curve size of 50°-65° in north Jordan.
Methods


Sixty-three adolescent patients with Scheuermann's kyphosis (aged between 10 and 18 years) were treated at our hospital between January 2014 and August 2018. All patients were investigated clinically, radiologically (Cobb's angle), and functionally (Oswestry Disability Index [ODI], Scoliosis Research Society 22 revision [SRS-22r] questionnaire, and pulmonary function test [PFT]) pre- and post-treatment (final follow-up). Patients were randomly selected for treatment method (conservative versus surgical).
Results


There were 31 patients (mean age, 15.48 ± 2.50 years) and 32 patients (mean age, 16.19 ± 1.51 years) treated conservatively and surgically, respectively. Mean ± standard deviation of ODI, SRS-22r, and Cobb's angle of the surgical group improved from 16.8% ± 14.3%, 3.5 ± 0.5, and 58.75° ± 3.59°, respectively, pre-surgery to 13.4% ± 10.8%, 4.2 ± 0.5, and 41.53° ± 3.94°, respectively, post-surgery, while those of the conservative group became worse from 12.6% ± 13.4%, 3.9 ± 0.7, and 56.1° ± 3.3°, respectively, to 20.1% ± 13.6%, 3.5 ± 0.7, and 58.8° ± 5.8°, respectively. The surgical group showed better improvement in all scores than the conservative group ( p  < 0.05), as well as in PFT.
Conclusions


Surgical treatment of Scheuermann's kyphosis with curves of 50°-65° resulted in better QOL, Cobb's angle, and PFT than conservative treatment. This was because of lower patient cooperation in the conservative management group, which made the curve less flexible for exercises and bracing.",2022,"The surgical group showed better improvement in all scores than the conservative group ( p  < 0.05), as well as in PFT.
","[""Scheuermann's Kyphosis Patients with Cobb's Angle 50°-65"", '31 patients (mean age, 15.48 ± 2.50 years) and 32 patients (mean age, 16.19 ± 1.51 years) treated conservatively and surgically, respectively', ""All patients were investigated clinically, radiologically (Cobb's angle), and functionally (Oswestry Disability Index [ODI], Scoliosis Research Society 22 revision [SRS-22r] questionnaire, and pulmonary function test [PFT]) pre- and post-treatment (final follow-up"", ""conservatively or surgically treated Scheuermann's disease patients with a curve size of 50°-65"", 'Patients with curves < 60° are treated conservatively, while surgery is used for patients with curves > 60°', ""Scheuermann's kyphosis with curves of 50°-65"", 'Treated Conservatively or Surgically in North Jordan', ""Methods\n\n\nSixty-three adolescent patients with Scheuermann's kyphosis (aged between 10 and 18 years) were treated at our hospital between January 2014 and August 2018""]",[],"['quality of life and functional changes', ""Mean ± standard deviation of ODI, SRS-22r, and Cobb's angle"", ""better QOL, Cobb's angle, and PFT"", 'Quality of Life']","[{'cui': 'C0036310', 'cui_str': 'Juvenile osteochondrosis of spine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",63.0,0.0174849,"The surgical group showed better improvement in all scores than the conservative group ( p  < 0.05), as well as in PFT.
","[{'ForeName': 'Ziad Ali', 'Initials': 'ZA', 'LastName': 'Audat', 'Affiliation': 'Department of Orthopedic Surgery, King Abdullah University Hospital, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Khalid Ahmed', 'Initials': 'KA', 'LastName': 'Kheirallah', 'Affiliation': 'Department of Public Health, Medical School, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Bayan Faisal', 'Initials': 'BF', 'LastName': 'Ababneh', 'Affiliation': 'Department of Public Health, Medical School, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Hisham Zaidon', 'Initials': 'HZ', 'LastName': 'Aljamal', 'Affiliation': 'Department of Orthopedic Surgery, King Abdullah University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Jomana Waleed', 'Initials': 'JW', 'LastName': 'Alsulaiman', 'Affiliation': 'Department of Pediatrics, Medical School, Yarmouk University, Irbid, Jordan.'}, {'ForeName': 'Yaman Sameer', 'Initials': 'YS', 'LastName': 'Bataineh', 'Affiliation': 'Department of Orthopedic Surgery, King Abdullah University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Mohammad Moneer', 'Initials': 'MM', 'LastName': 'Algharibeh', 'Affiliation': 'Department of Orthopedic Surgery, King Abdullah University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Abdarrahman Ziad', 'Initials': 'AZ', 'LastName': 'Audat', 'Affiliation': 'Department of Orthopedic Surgery, King Abdullah University of Science and Technology, Irbid, Jordan.'}]",Clinics in orthopedic surgery,['10.4055/cios20219']
2204,35709430,Food to Overcome Outcomes Disparities: A Randomized Controlled Trial of Food Insecurity Interventions to Improve Cancer Outcomes.,"PURPOSE


Food insecurity is prevalent among low-income immigrant and minority patients with cancer. To our knowledge, this randomized controlled trial is the first to prospectively examine the impact on cancer outcomes of food insecurity interventions, with the goal of informing evidence-based interventions to address food insecurity in patients with cancer.
METHODS


A three-arm randomized controlled trial was conducted among food-insecure (18-item US Department of Agriculture Household Food Security Survey Module score ≥ 3) patients with cancer (N = 117) at four New York City safety net cancer clinics. Arms included a hospital cancer clinic-based food pantry (arm 1), food voucher plus pantry (arm 2), and home grocery delivery plus pantry (arm 3). Treatment completion (primary outcome) and full appointment attendance were assessed at 6 months. Food security status, depression symptoms (Patient Health Questionnaire-9), and quality-of-life scores (Functional Assessment of Cancer Therapy-General) were assessed at baseline and at 6 months.
RESULTS


Voucher plus pantry had the highest treatment completion rate (94.6%), followed by grocery delivery plus pantry (82.5%) and pantry (77.5%;  P  = .046). Food security scores improved significantly in all arms, and Patient Health Questionnaire-9 and Functional Assessment of Cancer Therapy-General scores improved significantly in the pantry and delivery plus pantry arms.
CONCLUSION


Our findings in this preliminary study suggest that voucher plus pantry was the most effective intervention at improving treatment completion, and it met our a priori criterion for a promising intervention (≥ 90%). All interventions demonstrated the potential to improve food security among medically underserved, food-insecure patients with cancer at risk of impaired nutrition status, reduced quality of life, and poorer survival. All patients with cancer should be screened for food insecurity, with evidence-based food insecurity interventions made available.",2022,"Food security scores improved significantly in all arms, and Patient Health Questionnaire-9 and Functional Assessment of Cancer Therapy-General scores improved significantly in the pantry and delivery plus pantry arms.
","['All patients with cancer', 'low-income immigrant and minority patients with cancer', 'food-insecure (18-item US Department of Agriculture Household Food Security Survey Module score ≥ 3) patients with cancer (N = 117) at four New York City safety net cancer clinics', 'patients with cancer']","['hospital cancer clinic-based food pantry (arm 1), food voucher plus pantry (arm 2), and home grocery delivery plus pantry (arm 3', 'Food Insecurity Interventions']","['Patient Health Questionnaire-9 and Functional Assessment of Cancer Therapy-General scores', 'Food security scores', 'quality of life, and poorer survival', 'highest treatment completion rate', 'food security', 'full appointment attendance', 'Cancer Outcomes', 'Food security status, depression symptoms (Patient Health Questionnaire-9), and quality-of-life scores (Functional Assessment of Cancer Therapy-General']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.303144,"Food security scores improved significantly in all arms, and Patient Health Questionnaire-9 and Functional Assessment of Cancer Therapy-General scores improved significantly in the pantry and delivery plus pantry arms.
","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gany', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Melnic', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Minlun', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Finik', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ramirez', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Blinder', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kemeny', 'Affiliation': 'NYC Health + Hospitals/Queens, Queens, New York, NY.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Guevara', 'Affiliation': 'The Brooklyn Cancer Center, Brooklyn, New York, NY.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hwang', 'Affiliation': 'NYC Health + Hospitals/Lincoln, Bronx, New York, NY.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.02400']
2205,35709415,FLOT Versus FLOT/Trastuzumab/Pertuzumab Perioperative Therapy of Human Epidermal Growth Factor Receptor 2-Positive Resectable Esophagogastric Adenocarcinoma: A Randomized Phase II Trial of the AIO EGA Study Group.,"PURPOSE


High pathologic complete response (pCR) rates and comparably good survival data were seen in a phase II trial combining perioperative fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy with trastuzumab for resectable, esophagogastric adenocarcinoma (EGA). The current trial evaluates the addition of trastuzumab and pertuzumab to FLOT as perioperative treatment for human epidermal growth factor receptor 2-positive resectable EGA.
METHODS


In this multicenter, randomized phase II/III trial, patients with human epidermal growth factor receptor 2-positive, resectable EGA (≥ clinical tumor 2 or clinical nodal-positive) were assigned to four pre- and postoperative cycles of either FLOT alone (arm A) or combined with trastuzumab and pertuzumab, followed by nine cycles of trastuzumab/pertuzumab (arm B). The primary end point for the phase II part was the rate of pCR.
RESULTS


The trial was closed prematurely, without transition into phase III, after results of the JACOB trial were reported. Eighty-one patients were randomly assigned (A: 41/B: 40) during the phase II part. The pCR rate was significantly improved with the trastuzumab/pertuzumab treatment (A: 12%/B: 35%;  P  = .02). Similarly, the rate of pathologic lymph node negativity was higher with trastuzumab/pertuzumab (A: 39%/B: 68%), whereas the R0 resection rate (A: 90%/B: 93%) and surgical morbidity (A: 43%/B: 44%) were comparable. Moreover, the inhouse mortality was equal in both arms (overall 2.5%). The median disease-free survival was 26 months in arm A and not yet reached in arm B (hazard ratio 0.58;  P  = .14). After a median follow-up of 22 months, the median overall survival was not yet reached (hazard ratio 0.56;  P  = .24). Disease-free survival and overall survival rates (95% CI) at 24 months were 54% (38 to 71) and 77% (63 to 90) in arm A and 70% (55 to 85) and 84% (72 to 96) in arm B, respectively. More ≥ grade 3 adverse events were reported with trastuzumab/pertuzumab, especially diarrhea (A: 5%/B: 41%) and leukopenia (A: 13%/B: 23%).
CONCLUSION


The addition of trastuzumab/pertuzumab to perioperative FLOT significantly improved pCR and nodal negativity rates at the price of higher rates of diarrhea and leukopenia.",2022,The addition of trastuzumab/pertuzumab to perioperative FLOT significantly improved pCR and nodal negativity rates at the price of higher rates of diarrhea and leukopenia.,"['human epidermal growth factor receptor 2-positive resectable EGA', 'patients with human epidermal growth factor receptor 2-positive, resectable EGA (≥ clinical tumor 2 or clinical nodal-positive', 'resectable, esophagogastric adenocarcinoma (EGA', 'Eighty-one patients', 'Human Epidermal Growth Factor Receptor 2-Positive Resectable Esophagogastric Adenocarcinoma']","['trastuzumab/pertuzumab (A', 'perioperative fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy with trastuzumab', 'FLOT Versus FLOT/Trastuzumab/Pertuzumab Perioperative Therapy', 'FLOT alone (arm A) or combined with trastuzumab and pertuzumab, followed by nine cycles of trastuzumab/pertuzumab (arm B', 'trastuzumab and pertuzumab to FLOT']","['pCR and nodal negativity rates', 'inhouse mortality', 'diarrhea', 'surgical morbidity (A', 'median disease-free survival', 'median overall survival', 'rate of pathologic lymph node negativity', 'Disease-free survival and overall survival rates', 'rate of pCR', 'R0 resection rate', 'pCR rate', 'leukopenia']","[{'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C4517884', 'cui_str': '81'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}]",81.0,0.0917058,The addition of trastuzumab/pertuzumab to perioperative FLOT significantly improved pCR and nodal negativity rates at the price of higher rates of diarrhea and leukopenia.,"[{'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'Mannheim Cancer Center, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Merx', 'Affiliation': 'Mannheim Cancer Center, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Georg M', 'Initials': 'GM', 'LastName': 'Haag', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Springfeld', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ettrich', 'Affiliation': 'Department of Internal Medicine I, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Kersten', 'Initials': 'K', 'LastName': 'Borchert', 'Affiliation': 'Department of Hematology/ Oncology, Hospital Magdeburg gGmbH, Magdeburg, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Kretzschmar', 'Affiliation': 'Oncology, ÜBAG MVZ Mitte, Leipzig, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Teschendorf', 'Affiliation': 'Department of Internal Medicine, St.-Josefs-Hospital, Dortmund, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Siegler', 'Affiliation': 'Department of Internal Medicine 5, Hematology/ Oncology, Hospital Nürnberg Nord/Paracelsus Medical University, Nürnberg, Germany.'}, {'ForeName': 'Matthias P', 'Initials': 'MP', 'LastName': 'Ebert', 'Affiliation': 'Mannheim Cancer Center, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Eray', 'Initials': 'E', 'LastName': 'Goekkurt', 'Affiliation': 'Hematology-Oncology Practice, Specialist Center Eppendorf, University Cancer Center Hamburg (UCCH), Hamburg, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Mahlberg', 'Affiliation': 'Medical Department I, Hospital Mutterhaus Trier, Trier, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Homann', 'Affiliation': 'Medical Department II, Hospital Wolfsburg, Wolfsburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pink', 'Affiliation': 'Sarcoma Center Berlin-Brandenburg, Helios Hospital Bad Saarow, Bad Saarow, Germany.'}, {'ForeName': 'Wolf', 'Initials': 'W', 'LastName': 'Bechstein', 'Affiliation': 'Department of General and Visceral Surgery, Frankfurt University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Sarcoma Center Berlin-Brandenburg, HELIOS Klinikum Berlin Buch, Berlin, Germany.'}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Flach', 'Affiliation': 'Department of Hematology and Oncology, Pius Hospital, University Hospital Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Gaiser', 'Affiliation': 'Institute of Pathology, Medical Faculty Mannheim, University Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Battmann', 'Affiliation': 'Institute of Pathology, Hospital Northwest, Frankfurt am Main, Germany.'}, {'ForeName': 'Fuat S', 'Initials': 'FS', 'LastName': 'Oduncu', 'Affiliation': 'Department of Hematology and Oncology, Medizinische Klinik und Poliklinik III, University Hospital München, München, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Loose', 'Affiliation': 'Institute for Clinical Cancer Research IKF at Hospital Northwest, Frankfurt am Main, Germany.'}, {'ForeName': 'Disorn', 'Initials': 'D', 'LastName': 'Sookthai', 'Affiliation': 'Institute for Clinical Cancer Research IKF at Hospital Northwest, Frankfurt am Main, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pauligk', 'Affiliation': 'Institute for Clinical Cancer Research IKF at Hospital Northwest, Frankfurt am Main, Germany.'}, {'ForeName': 'Thorsten O', 'Initials': 'TO', 'LastName': 'Göetze', 'Affiliation': 'Institute for Clinical Cancer Research IKF at Hospital Northwest, Frankfurt am Main, Germany.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Institute for Clinical Cancer Research IKF at Hospital Northwest, Frankfurt am Main, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.22.00380']
2206,35709245,"The comparison of brief, online mindfulness and relaxation interventions to reduce stress and improve sleep-related outcomes in college students.","OBJECTIVE


The current study aimed to examine whether brief online stress reduction exercises supplemented with sleep improvement strategies would reduce stress, arousal, and sleep difficulties in college students who were not required to use the sleep improvement strategies for participation.
PARTICIPANTS


A sample of 114 college student participants were enrolled because they were experiencing stress and/or wanted to improve their sleep.
METHODS


Participants were randomized into an abbreviated progressive muscle relaxation, a mindful breathing, or a self-monitoring control condition for the 4-week intervention. Measures of physical relaxation, mindfulness, perceived stress, pre-sleep arousal, and insomnia symptom severity were collected.
RESULTS


The APMR group improved on five of the six dependent measures and was significantly different than the SM group at posttest, but not different than the MB group.
CONCLUSION


The results suggests promise for brief, online, scaled back stress reduction interventions to reduce stress, arousal, and sleep difficulties in college students.",2022,"The APMR group improved on five of the six dependent measures and was significantly different than the SM group at posttest, but not different than the MB group.
","['Participants', 'college students who were not required to use the sleep improvement strategies for participation', 'A sample of 114 college student participants were enrolled because they were experiencing stress and/or wanted to improve their sleep', 'college students']","['online stress reduction exercises supplemented with sleep improvement strategies', 'online mindfulness and relaxation interventions', 'abbreviated progressive muscle relaxation, a mindful breathing, or a self-monitoring control condition for the 4-week intervention']","['physical relaxation, mindfulness, perceived stress, pre-sleep arousal, and insomnia symptom severity', 'stress, arousal, and sleep difficulties']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}]",114.0,0.0277163,"The APMR group improved on five of the six dependent measures and was significantly different than the SM group at posttest, but not different than the MB group.
","[{'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Pickett', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, College of Medicine, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Andrea T', 'Initials': 'AT', 'LastName': 'Kozak', 'Affiliation': 'Department of Psychology, Oakland University, Rochester, Michigan, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lanni', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Warnke', 'Affiliation': 'Department of Psychology, Oakland University, Rochester, Michigan, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaillard', 'Affiliation': 'Office of Clinical Research Advancement, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychology, Oakland University, Rochester, Michigan, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2022.2066979']
2207,35709685,Comparative single dose pharmacokinetics and metabolism of racemic primaquine and its enantiomers in human volunteers.,"Primaquine (PQ) is a racemic drug used in treatment of malaria for six decades. Recent studies suggest that the two enantiomers of PQ are differentially metabolized in animals, and this results in different pharmacological and toxicological profiles. The current study characterizes the pharmacokinetic (PK) properties, metabolism and tolerability of the individual enantiomers of PQ in healthy human volunteers with normal glucose-6-phosphate dehydrogenase (G6PD) activity. Two cohorts (at two dose levels), each with 18 subjects, participated in three study arms in a crossover fashion: a single dose of the (-)-R enantiomer (RPQ), a single dose of the (+)-S enantiomer (SPQ), and a single dose of racemic PQ (RSPQ). PQ and its key metabolites carboxyprimaquine (cPQ) and PQ-N-carbamoyl glucuronide (PQ-N-CG) were analyzed. Clear differences were observed in PK and metabolism of the two enantiomers. Relative PQ exposure was higher with SPQ as compared to RPQ. PQ maximum plasma concentration (C max ) and area under the plasma concentration-time curve were higher for SPQ, while the apparent volume of distribution and total body clearance were higher for RPQ. Metabolism of the two enantiomers showed dramatic differences: plasma PQ-N-CG was derived solely from SPQ, while RPQ was much more efficiently converted to cPQ than was SPQ. C max  of cPQ and PQ-N-CG were 10 and 2 times higher, respectively, than the parent drugs. The study demonstrates that the PK properties of PQ enantiomers show clear differences, and metabolism is highly enantioselective. Such differences in metabolism suggest potentially distinct toxicity profiles in multi-dose regimens, especially in G6PD-deficient subjects.",2022,"PQ maximum plasma concentration (C max ) and area under the plasma concentration-time curve were higher for SPQ, while the apparent volume of distribution and total body clearance were higher for RPQ.","['healthy human volunteers with normal glucose-6-phosphate dehydrogenase (G6PD) activity', 'human volunteers']","['R enantiomer (RPQ), a single dose of the (+)-S enantiomer (SPQ), and a single dose of racemic PQ (RSPQ', 'Primaquine (PQ', 'racemic primaquine', 'PQ and its key metabolites carboxyprimaquine (cPQ) and PQ-N-carbamoyl glucuronide (PQ-N-CG']","['PK and metabolism', 'PQ maximum plasma concentration (C max ) and area under the plasma concentration-time curve', 'Relative PQ exposure', 'dramatic differences: plasma PQ-N-CG', 'C max  of cPQ and PQ-N-CG', 'distribution and total body clearance', 'pharmacokinetic (PK) properties, metabolism and tolerability']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0108478', 'cui_str': 'carboxyprimaquine'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0108478', 'cui_str': 'carboxyprimaquine'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.0533469,"PQ maximum plasma concentration (C max ) and area under the plasma concentration-time curve were higher for SPQ, while the apparent volume of distribution and total body clearance were higher for RPQ.","[{'ForeName': 'Washim', 'Initials': 'W', 'LastName': 'Khan', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'Narayan D', 'Initials': 'ND', 'LastName': 'Chaurasiya', 'Affiliation': 'Department of Infectious Diseases, Division of Drug Discovery, Southern Research Institute, Birmingham, AL, 35205, USA.'}, {'ForeName': 'Np Dhammika', 'Initials': 'ND', 'LastName': 'Nanayakkara', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'Hm Bandara', 'Initials': 'HB', 'LastName': 'Herath', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'Kerri A', 'Initials': 'KA', 'LastName': 'Harrison', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'Gray', 'Initials': 'G', 'LastName': 'Dale', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Stanford', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Dahl', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'McChesney', 'Affiliation': 'Ironstone Separations, Inc., Etta, MS, 38627, USA.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Gul', 'Affiliation': 'ElSohly Laboratories, Inc., Oxford, MS, 38655, USA.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'ElSohly', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA; Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS, 38677, USA; ElSohly Laboratories, Inc., Oxford, MS, 38655, USA.'}, {'ForeName': 'Shabana I', 'Initials': 'SI', 'LastName': 'Khan', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'Pius S', 'Initials': 'PS', 'LastName': 'Fasinu', 'Affiliation': 'Department of Pharmacology & Toxicology, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Ikhlas A', 'Initials': 'IA', 'LastName': 'Khan', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA; Departments of BioMolecular Sciences, School of Pharmacy, The University of Mississippi, University, MS, 38677, USA.'}, {'ForeName': 'Babu L', 'Initials': 'BL', 'LastName': 'Tekwani', 'Affiliation': 'Department of Infectious Diseases, Division of Drug Discovery, Southern Research Institute, Birmingham, AL, 35205, USA. Electronic address: btekwani@southernresearch.org.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Walker', 'Affiliation': 'National Center for Natural Products Research, The University of Mississippi, University, MS, 38677, USA. Electronic address: lwalker@olemiss.edu.'}]",Drug metabolism and pharmacokinetics,['10.1016/j.dmpk.2022.100463']
2208,35709650,"Treatment with metformin glycinate reduces SARS-CoV-2 viral load: An in vitro model and randomized, double-blind, Phase IIb clinical trial.","The health crisis caused by the new coronavirus SARS-CoV-2 highlights the need to identify new treatment strategies for this viral infection. During the past year, over 400 coronavirus disease (COVID-19) treatment patents have been registered; nevertheless, the presence of new virus variants has triggered more severe disease presentations and reduced treatment effectiveness, highlighting the need for new treatment options for the COVID-19. This study evaluates the Metformin Glycinate (MG) effect on the SARS-CoV-2 in vitro and in vivo viral load. The in vitro study was conducted in a model of Vero E6 cells, while the in vivo study was an adaptive, two-armed, randomized, prospective, longitudinal, double-blind, multicentric, and phase IIb clinical trial. Our in vitro results revealed that MG effectively inhibits viral replication after 48 h of exposure to the drug, with no cytotoxic effect in doses up to 100 µM. The effect of the MG was also tested against three variants of interest (alpha, delta, and epsilon), showing increased survival rates in cells treated with MG. These results are aligned with our clinical data, which indicates that MG treatment reduces SARS-CoV2-infected patients´ viral load in just 3.3 days and supplementary oxygen requirements compared with the control group. We expect our results can guide efforts to position MG as a therapeutic option for COVID-19 patients.",2022,The health crisis caused by the new coronavirus SARS-CoV-2 highlights the need to identify new treatment strategies for this viral infection.,['COVID-19 patients'],"['Metformin Glycinate (MG', 'metformin glycinate']","['SARS-CoV-2 viral load', 'survival rates', 'viral replication']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0042774', 'cui_str': 'Virus Replication'}]",,0.196198,The health crisis caused by the new coronavirus SARS-CoV-2 highlights the need to identify new treatment strategies for this viral infection.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ventura-López', 'Affiliation': 'Departamento de Innovación Biomédica, CICESE, Carretera Ensenada-Tijuana 3918, Zona Playitas, Ensenada, BC 22860, Mexico. Electronic address: cventura@cicese.mx.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Cervantes-Luevano', 'Affiliation': 'Departamento de Innovación Biomédica, CICESE, Carretera Ensenada-Tijuana 3918, Zona Playitas, Ensenada, BC 22860, Mexico. Electronic address: kcervates@cicese.mx.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Aguirre-Sánchez', 'Affiliation': 'The American British Cowdray Medical Center I.A.P. (Centro Médico ABC), Mexico. Electronic address: janetaguirre@yahoo.com.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Flores-Caballero', 'Affiliation': 'The American British Cowdray Medical Center I.A.P. (Centro Médico ABC), Mexico. Electronic address: juancarlosfl18@hotmail.com.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Alvarez-Delgado', 'Affiliation': 'Departamento de Innovación Biomédica, CICESE, Carretera Ensenada-Tijuana 3918, Zona Playitas, Ensenada, BC 22860, Mexico. Electronic address: alvarezc@cicese.mx.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bernaldez-Sarabia', 'Affiliation': 'Departamento de Innovación Biomédica, CICESE, Carretera Ensenada-Tijuana 3918, Zona Playitas, Ensenada, BC 22860, Mexico. Electronic address: jbernald@cicese.mx.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Sánchez-Campos', 'Affiliation': 'Departamento de Innovación Biomédica, CICESE, Carretera Ensenada-Tijuana 3918, Zona Playitas, Ensenada, BC 22860, Mexico. Electronic address: lsanchez@cicese.mx.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Lugo-Sánchez', 'Affiliation': 'Laboratorio Silanes S.A. de C.V., CdMx, Mexico. Electronic address: llugo@silanes.com.mx.'}, {'ForeName': 'Ileana C', 'Initials': 'IC', 'LastName': 'Rodríguez-Vázquez', 'Affiliation': 'Laboratorio Silanes S.A. de C.V., CdMx, Mexico. Electronic address: icrodriguez@silanes.com.mx.'}, {'ForeName': 'Jose G', 'Initials': 'JG', 'LastName': 'Sander-Padilla', 'Affiliation': 'Laboratorio Silanes S.A. de C.V., CdMx, Mexico. Electronic address: jgsander@silanes.com.mx.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Romero-Antonio', 'Affiliation': 'Laboratorio Silanes S.A. de C.V., CdMx, Mexico. Electronic address: yromero@silanes.com.mx.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Arguedas-Núñez', 'Affiliation': 'Laboratorio Silanes S.A. de C.V., CdMx, Mexico. Electronic address: marguedas@silanes.com.mx.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'González-Canudas', 'Affiliation': 'Laboratorio Silanes S.A. de C.V., CdMx, Mexico. Electronic address: jogonzalez@silanes.com.mx.'}, {'ForeName': 'Alexei F', 'Initials': 'AF', 'LastName': 'Licea-Navarro', 'Affiliation': 'Departamento de Innovación Biomédica, CICESE, Carretera Ensenada-Tijuana 3918, Zona Playitas, Ensenada, BC 22860, Mexico. Electronic address: alicea@cicese.mx.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2022.113223']
2209,35709647,"Impact of childhood trauma on antipsychotic effectiveness in schizophrenia spectrum disorders: A prospective, pragmatic, semi-randomized trial.","Antipsychotic medications are generally effective in ameliorating psychotic symptoms in schizophrenia spectrum disorders (SSDs). Identifying predictors associated with poor treatment response is important for a personalized treatment approach. Childhood trauma (CT) may have a general and differential effect on the effectiveness of different types of antipsychotics in SSDs. The Bergen-Stavanger-Trondheim-Innsbruck (BeSt InTro) study is a pragmatic, researcher-initiated, semi-randomized trial. The present study aimed to investigate symptom change (the Positive and Negative Syndrome Scale) from baseline to 1, 3, 6, 12, 26, 39 and 52 weeks of antipsychotic treatment (amisulpride, aripiprazole and olanzapine) by group (CT/no CT). Participants (n = 98) with diagnoses within the schizophrenia spectrum (F20-29 in the International Classification of Diseases - 10th Revision) were randomized to receive amisulpride, aripiprazole or olanzapine, and for this study categorized into groups of none and low CT, and moderate to severe CT according to thresholds defined by the Childhood Trauma Questionnaire Short-Form manual. CT in SSDs predicted an overall slower treatment response and less antipsychotic effectiveness after 26 weeks of treatment, which was statistically nonsignificant at 52 weeks. Secondary analyses showed a differential effect of CT related to type of antipsychotic medication: patients with SSDs and CT who received olanzapine showed less antipsychotic effectiveness throughout 52 weeks of treatment. The intention-to-treat and per-protocol analyses were convergent. Our findings indicate that in patients with SSD and CT, delayed response to antipsychotics could be expected, and a longer evaluation period before considering change of medication may be recommended.",2022,"CT in SSDs predicted an overall slower treatment response and less antipsychotic effectiveness after 26 weeks of treatment, which was statistically nonsignificant at 52 weeks.","['Participants (n\xa0=\xa098) with diagnoses within the schizophrenia spectrum (F20-29 in the International Classification of Diseases - 10th Revision', 'schizophrenia spectrum disorders']","['antipsychotic treatment (amisulpride, aripiprazole and olanzapine) by group (CT/no CT', 'amisulpride, aripiprazole or olanzapine', 'olanzapine', 'Antipsychotic medications', 'CT']",['antipsychotic effectiveness'],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",98.0,0.0283743,"CT in SSDs predicted an overall slower treatment response and less antipsychotic effectiveness after 26 weeks of treatment, which was statistically nonsignificant at 52 weeks.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mørkved', 'Affiliation': 'Mosjøen District Psychiatric Centre, Helgeland Hospital, Skjervengan 17, 8657 Mosjøen, Norway; Department of Psychology, UiT The Arctic University of Norway, Pb 6050 Langnes, 9037 Tromsø, Norway. Electronic address: nina.morkved@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Johnsen', 'Affiliation': 'NORMENT Centre of Excellence and Division of Psychiatry, Haukeland University Hospital, Jonas Lies vei 65, 5021 Bergen, Norway; Department of Clinical Medicine, University of Bergen, Pb 7800, 5020 Bergen, Norway.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Kroken', 'Affiliation': 'NORMENT Centre of Excellence and Division of Psychiatry, Haukeland University Hospital, Jonas Lies vei 65, 5021 Bergen, Norway; Department of Clinical Medicine, University of Bergen, Pb 7800, 5020 Bergen, Norway.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Winje', 'Affiliation': 'Faculty of Psychology, Department of Clinical Psychology, University of Bergen, Christies gate 13, 5015 Bergen, Norway.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Larsen', 'Affiliation': 'Institute of Psychiatry, University of Bergen, Pb 7800, 5020 Bergen, Norway; TIPS Centre for Clinical Research in Psychosis, Division of Psychiatry, Stavanger University Hospital, Jan Johnsens gate12, 4011 Stavanger, Norway.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Thimm', 'Affiliation': 'Department of Psychology, UiT The Arctic University of Norway, Pb 6050 Langnes, 9037 Tromsø, Norway; Center for Crisis Psychology, University of Bergen, 5009 Bergen, Norway.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Rettenbacher', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'C A Bartz', 'Initials': 'CAB', 'LastName': 'Johannesen', 'Affiliation': 'NORMENT Centre of Excellence and Division of Psychiatry, Haukeland University Hospital, Jonas Lies vei 65, 5021 Bergen, Norway; Department of Clinical Medicine, University of Bergen, Pb 7800, 5020 Bergen, Norway.'}, {'ForeName': 'E-M', 'Initials': 'EM', 'LastName': 'Løberg', 'Affiliation': 'NORMENT Centre of Excellence and Division of Psychiatry, Haukeland University Hospital, Jonas Lies vei 65, 5021 Bergen, Norway; Faculty of Psychology, Department of Clinical Psychology, University of Bergen, Christies gate 13, 5015 Bergen, Norway; Department of Addiction Medicine, Haukeland University Hospital, Østre Murallmenningen 7, 5012 Bergen, Norway.'}]",Schizophrenia research,['10.1016/j.schres.2022.05.022']
2210,35709600,"Fatigue, health-related quality-of-life and metabolic changes in men treated with enzalutamide or abiraterone acetate plus prednisone for metastatic castration-resistant prostate cancer: A randomised clinical trial (HEAT).","INTRODUCTION


Enzalutamide and abiraterone acetate plus prednisone (AAP) have similar efficacy in metastatic castration-resistant prostate cancer (mCRPC). Herein, we compare fatigue, health-related quality-of-life (HRQoL) and metabolic changes in men with mCRPC treated with enzalutamide and AAP.
MATERIALS AND METHODS


In this single-centre, open-labelled, phase IV trial, patients with metastatic prostate cancer progressing on androgen deprivation therapy were randomly assigned to enzalutamide (160 mg daily) or AAP (1000 mg abiraterone acetate and 10 mg prednisone daily) as first-line mCRPC treatment. The primary outcome was the difference in changed fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire). The secondary outcomes were differences in changed HRQoL (Functional Assessment of Cancer Therapy-Prostate questionnaire), body composition, weight, glucose homeostasis, lipid profile and blood pressure. All outcomes were assessed at baseline and at 12-week follow-up.
TRIAL REGISTRATION


clinicaltrialsregister.eu (2017-000099-27).
RESULTS


170 patients were randomised (1:1) to enzalutamide or AAP. The primary outcome was positive with a clinically meaningful difference in fatigue, favouring AAP (3.4 points, 95% CI 1.2; 5.6, P = 0.003). The group difference in changed HRQoL did not reach clinical significance. The most important metabolic finding was a higher increase in glycated haemoglobin (HbA1c) for AAP than enzalutamide (3.4 mmol/mol, 95% CI 2.1; 4.8, P = 0.001). Eight patients developed type 2 diabetes (T2D) in the AAP group and none in the enzalutamide group. No treatment-related serious adverse event was observed.
CONCLUSIONS


AAP resulted in less fatigue than enzalutamide in a randomised setting. This was at the expense of a higher HbA1c increase and incidence of T2D.",2022,"The most important metabolic finding was a higher increase in glycated haemoglobin (HbA1c) for AAP than enzalutamide (3.4 mmol/mol, 95% CI 2.1; 4.8, P = 0.001).","['patients with metastatic prostate cancer progressing on androgen deprivation therapy', 'men with mCRPC treated with enzalutamide and AAP', 'metastatic castration-resistant prostate cancer (mCRPC', 'men treated with', '170 patients', 'for metastatic castration-resistant prostate cancer', 'Eight patients developed type 2 diabetes (T2D) in the AAP group and none in the enzalutamide group']","['Enzalutamide and abiraterone acetate plus prednisone (AAP', 'enzalutamide or abiraterone acetate plus prednisone', 'enzalutamide', 'enzalutamide or AAP', 'AAP (1000\xa0mg abiraterone acetate and 10\xa0mg prednisone', 'AAP']","['fatigue', 'Fatigue, health-related quality-of-life and metabolic changes', 'changed fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire', 'changed HRQoL (Functional Assessment of Cancer Therapy-Prostate questionnaire), body composition, weight, glucose homeostasis, lipid profile\xa0and blood pressure', 'positive with a clinically meaningful difference in fatigue, favouring AAP', 'fatigue, health-related quality-of-life (HRQoL) and metabolic changes', 'glycated haemoglobin (HbA1c) for AAP', 'changed HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",170.0,0.344631,"The most important metabolic finding was a higher increase in glycated haemoglobin (HbA1c) for AAP than enzalutamide (3.4 mmol/mol, 95% CI 2.1; 4.8, P = 0.001).","[{'ForeName': 'Klara K', 'Initials': 'KK', 'LastName': 'Ternov', 'Affiliation': 'Department of Urology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: klara.kvorning.ternov@regionh.dk.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sønksen', 'Affiliation': 'Department of Urology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Fode', 'Affiliation': 'Department of Urology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Urology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Lindberg', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Bisbjerg', 'Affiliation': 'Department of Urology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tobias W', 'Initials': 'TW', 'LastName': 'Klausen', 'Affiliation': 'Department of Haematology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Palapattu', 'Affiliation': 'Department of Urology, Michigan Medicine, Ann Arbor, USA; Department of Urology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Østergren', 'Affiliation': 'Department of Urology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Urology, Zealand University Hospital, Roskilde, Denmark.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.04.034']
2211,35709728,Effect of Routine Gastric Residual Aspiration on the Preterm Infant Fecal Microbiome.,"OBJECTIVE


Enteral feeding tubes are used in neonatal intensive care units (NICU) to assess feeding tolerance by utilizing pre-prandial gastric residual aspiration. This study evaluates the effect of gastric residual aspiration on the preterm infant fecal microbiome and gastrointestinal inflammation.
STUDY DESIGN


Fifty-one very low birth weight (VLBW) infants (<32 weeks gestational age and <1250g) enrolled in a larger single-center randomized controlled trial evaluating the effects of routine and non-routine gastric residual aspiration were selected for further analysis. Of those infants, 30 infants had microbiome analysis performed on stools collected at 6 weeks by sequencing the bacterial V1-V3 variable regions of the genes encoding for 16S rRNA. In an additional 21 infants, stool samples collected at 3- and 6-weeks were analyzed for intestinal inflammation using a cytokine multiplex panel.
RESULTS


Microbial communities between groups were not distinct from each other and there was no difference in intestinal inflammation between groups. Analyses using gene expression packages DESeq2 and edgeR produced statistically significant differences in several taxa possibly indicating a more commensal intestinal microbiome in infants not undergoing gastric residual aspiration.
CONCLUSION


Omission of routine gastric residual aspiration was not associated with intestinal dysbiosis or inflammation, providing additional evidence that monitoring pre-prandial gastric residuals is unnecessary.",2022,"RESULTS


Microbial communities between groups were not distinct from each other and there was no difference in intestinal inflammation between groups.","['Fifty-one very low birth weight (VLBW) infants (<32 weeks gestational age and <1250g) enrolled in a larger single-center', 'infants not undergoing gastric residual aspiration']","['gastric residual aspiration', 'Routine Gastric Residual Aspiration', 'routine and non-routine gastric residual aspiration']","['Preterm Infant Fecal Microbiome', 'commensal intestinal microbiome', 'intestinal inflammation']","[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517554', 'cui_str': '1250'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3665864', 'cui_str': 'Gastric residual assessment'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]","[{'cui': 'C3665864', 'cui_str': 'Gastric residual assessment'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0542329', 'cui_str': 'Commensal parasite'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}]",51.0,0.0996282,"RESULTS


Microbial communities between groups were not distinct from each other and there was no difference in intestinal inflammation between groups.","[{'ForeName': 'Mary Windham', 'Initials': 'MW', 'LastName': 'Lenfestey', 'Affiliation': 'Pediatrics, Brody School of Medicine at East Carolina University, Greenville, United States.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Pediatrics-Neonatology, University of Florida, Gainesville, United States.'}, {'ForeName': 'Josee', 'Initials': 'J', 'LastName': 'Gauthier', 'Affiliation': 'University of Florida, Gainesville, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Winglee', 'Affiliation': 'College of Computing and Informatics, The University of North Carolina at Charlotte, Charlotte, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fodor', 'Affiliation': 'College of Computing and Informatics, The University of North Carolina at Charlotte, Charlotte, United States.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'College of Computing and Informatics, The University of North Carolina at Charlotte, Charlotte, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jobin', 'Affiliation': 'University of Florida, Gainesville, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Neu', 'Affiliation': 'Pediatrics-Neonatology, University of Florida, Gainesville, United States.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Parker', 'Affiliation': 'University of Florida, Gainesville, United States.'}]",American journal of perinatology,['10.1055/a-1877-6306']
2212,35710164,"The effect of a fruit-rich diet on liver biomarkers, insulin resistance, and lipid profile in patients with non-alcoholic fatty liver disease: a randomized clinical trial.","BACKGROUND


Despite confirmed dietary approaches to improve the Non-Alcoholic Fatty Liver Disease (NAFLD), the effect of fruits on NAFLD is not clear. The present study aimed to investigate the effect of a fruit rich diet (FRD) on liver steatosis, liver enzymes, Insulin resistance, and lipid profile in patients with NAFLD.
METHODS


Eighty adults with NAFLD participated in this randomized controlled trial. The participants were randomly assigned to the FRD group with consumption of at least 4 servings of fruits daily or the control group with fruits consumption of less than 2 servings/day. The grade of steatosis, serum levels of liver enzymes including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and gamma-glutamyl transferase (GGT), total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), glucose, and homeostatic model assessment for insulin resistance (HOMA-IR) were measured at the baseline and at the end of the study.
RESULTS


After 6 months of intervention, the FRD group had significantly higher BMI (31.40 ± 2.61 vs. 25.68 ± 2.54,  p  < .001), WC (113.5 ± 10.7 vs. 100.5 ± 7.5,  p  < .001), the grade of steatosis, ALT (89.1 ± 92.9 vs. 32.0 ± 19.2,  p  < .001), AST (74.5 ± 107.8 vs. 24.0 ± 8.5,  p  < .001), ALP (273.4 ± 128.5 vs. 155.0 ± 43.9,  p  < .001), GGT (92.7 ± 16.2 vs. 21.2 ± 7.7,  p  < .001), TC (206.1 ± 40.5 vs. 172.7 ± 42.4,  p  < .01), LDL (126.9 ± 32.3 vs. 99.8 ± 29.8,  p  < .001), glucose (115.5 ± 30.0 vs. 97.7 ± 19.0,  p  < .01), and insulin resistance (7.36 ± 4.37 vs. 2.66 ± 1.27,  p  < .001), and lower HDL (41.4 ± 8.9 vs. 53.8 ± 15.1,  p  < .001) compared to the control group. Adjusting for BMI and calorie intake did not change the results.
CONCLUSION


The results of the present study indicated that consumption of fruits more than 4 servings/day exacerbates steatosis, dyslipidemia, and glycemic control in NAFLD patients. Further studies are needed to identify the underlying mechanisms of the effects of fruits on NAFLD.
CLINICAL TRIAL REGISTRATION


This trial was registered at Iranian randomized clinical trial website with IRCT registration no. IRCT20201010048982N1on October 15, 2020.",2022,"p  < .001), glucose (115.5 ± 30.0 vs. 97.7 ± 19.0,  p  < .01), and insulin resistance (7.36 ± 4.37 vs. 2.66 ± 1.27,  p  < .001), and lower HDL (41.4 ± 8.9 vs. 53.8 ± 15.1,  p  < .001)","['patients with non-alcoholic fatty liver disease', 'Eighty adults with NAFLD participated', 'patients with NAFLD']","['fruit rich diet (FRD', 'fruit-rich diet', 'IRCT registration', 'FRD group with consumption of at least 4 servings of fruits daily or the control group with fruits consumption of less than 2 servings/day']","['grade of steatosis, serum levels of liver enzymes including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and gamma-glutamyl transferase (GGT), total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), glucose, and homeostatic model assessment for insulin resistance (HOMA-IR', 'BMI', 'grade of steatosis, ALT', 'insulin resistance', 'BMI and calorie intake', 'liver biomarkers, insulin resistance, and lipid profile', 'steatosis, dyslipidemia, and glycemic control', 'liver steatosis, liver enzymes, Insulin resistance, and lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}]",80.0,0.309887,"p  < .001), glucose (115.5 ± 30.0 vs. 97.7 ± 19.0,  p  < .01), and insulin resistance (7.36 ± 4.37 vs. 2.66 ± 1.27,  p  < .001), and lower HDL (41.4 ± 8.9 vs. 53.8 ± 15.1,  p  < .001)","[{'ForeName': 'Farkhondeh', 'Initials': 'F', 'LastName': 'Alami', 'Affiliation': 'Student Research Committee, Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Food and Beverages Safety Research Center, Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shateri', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2022.2071109']
2213,35710124,"Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID).","OBJECTIVE


To determine if guided internet based cognitive behavioural therapy with a trauma focus (CBT-TF) is non-inferior to individual face-to-face CBT-TF for mild to moderate post-traumatic stress disorder (PTSD) to one traumatic event.
DESIGN


Pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID).
SETTING


Primary and secondary mental health settings across the UK's NHS.
PARTICIPANTS


196 adults with a primary diagnosis of mild to moderate PTSD were randomised in a 1:1 ratio to one of two interventions, with 82% retention at 16 weeks and 71% retention at 52 weeks. 19 participants and 10 therapists were purposively sampled and interviewed for evaluation of the process.
INTERVENTIONS


Up to 12 face-to-face, manual based, individual CBT-TF sessions, each lasting 60-90 minutes; or guided internet based CBT-TF with an eight step online programme, with up to three hours of contact with a therapist and four brief telephone calls or email contacts between sessions.
MAIN OUTCOME MEASURES


Primary outcome was the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 16 weeks after randomisation (diagnosis of PTSD based on the criteria of the  Diagnostic and Statistical Manual of Mental Disorders , fifth edition, DSM-5). Secondary outcomes included severity of PTSD symptoms at 52 weeks, and functioning, symptoms of depression and anxiety, use of alcohol, and perceived social support at 16 and 52 weeks after randomisation.
RESULTS


Non-inferiority was found at the primary endpoint of 16 weeks on the CAPS-5 (mean difference 1.01, one sided 95% confidence interval -∞ to 3.90, non-inferiority P=0.012). Improvements in CAPS-5 score of more than 60% in the two groups were maintained at 52 weeks, but the non-inferiority results were inconclusive in favour of face-to-face CBT-TF at this time point (3.20, -∞ to 6.00, P=0.15). Guided internet based CBT-TF was significantly (P<0.001) cheaper than face-to-face CBT-TF and seemed to be acceptable and well tolerated by participants. The main themes of the qualitative analysis were facilitators and barriers to engagement with guided internet based CBT-TF, treatment outcomes, and considerations for its future implementation.
CONCLUSIONS


Guided internet based CBT-TF for mild to moderate PTSD to one traumatic event was non-inferior to individual face-to-face CBT-TF and should be considered a first line treatment for people with this condition.
TRIAL REGISTRATION


ISRCTN13697710.",2022,Guided internet based CBT-TF was significantly (P<0.001) cheaper than face-to-face CBT-TF and seemed to be acceptable and well tolerated by participants.,"[""Primary and secondary mental health settings across the UK's NHS"", '196 adults with a primary diagnosis of mild to moderate PTSD', '19 participants and 10 therapists were purposively sampled and interviewed for evaluation of the process']","['guided internet based CBT-TF with an eight step online programme, with up to three hours of contact with a therapist and four brief telephone calls or email contacts between sessions', 'Guided, internet based, cognitive behavioural therapy', 'guided internet based cognitive behavioural therapy with a trauma focus (CBT-TF']","['Clinician Administered PTSD Scale for DSM-5 (CAPS-5', 'severity of PTSD symptoms at 52 weeks, and functioning, symptoms of depression and anxiety, use of alcohol, and perceived social support', 'CAPS-5', 'CAPS-5 score']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0013849', 'cui_str': 'Email'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",196.0,0.131112,Guided internet based CBT-TF was significantly (P<0.001) cheaper than face-to-face CBT-TF and seemed to be acceptable and well tolerated by participants.,"[{'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Bisson', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK bissonji@cardiff.ac.uk.'}, {'ForeName': 'Cono', 'Initials': 'C', 'LastName': 'Ariti', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Cullen', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kitchiner', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Neil P', 'Initials': 'NP', 'LastName': 'Roberts', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Simon', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Smallman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Addison', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Bell', 'Affiliation': 'Division of Nursing, Midwifery, and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cosgrove', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Ehlers', 'Affiliation': 'University of Oxford and Oxford Health NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fitzsimmons', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Foscarini-Craggs', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Shaun R S', 'Initials': 'SRS', 'LastName': 'Harris', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kelson', 'Affiliation': 'Department of Mathematics, College of Engineering, Mathematics and Physical Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Lovell', 'Affiliation': 'Division of Nursing, Midwifery, and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'McKenna', 'Affiliation': 'NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'McNamara', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Nollett', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Williams-Thomas', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj-2021-069405']
2214,35710102,Improved blood pressure and flow-mediated dilation via increased plasma adropin and NOx induced by high-intensity interval training in patients with type 2 diabetes.,"NEW FINDINGS


What is the central question of this study? Exercise training increases adropin and NOx plasma levels in middle-aged and older healthy people. We hypothesized that high-intensity interval training may improve blood pressure and flow-mediated dilation through the effects of adropin and NOx in patients of this age with type 2 diabetes. What is the main finding and its importance? High-intensity interval training may be more effective than moderate-intensity continuous training in improving endothelial function, blood pressure and flow-mediated dilation through its effects on adropin and NOx in patients with type 2 diabetes.
ABSTRACT


Adropin is a newly identified bioactive protein that is important in energy hemostasis and vascular endothelial function. Lower levels of adropin in patients with type 2 diabetes are related to coronary atherosclerosis, characterized by impaired flow-mediated dilation (FMD). The purpose of the present study was to investigate FMD, and plasma levels of adropin and nitrite/nitrate (NOx), in patients with type 2 diabetes at baseline and follow-up after 12 weeks of high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT). Sixty-six persons with type 2 diabetes were divided into HIIT, MICT and control groups. The HIIT group intervention was 12 intervals (1.5 min) at 85% to 90% maximal heart rate (HR max  ) separated by 2 min at 55% to 60% HR max  in 3 session per week for 12 weeks. MICT training consisted of 42 min of cycling at 70% HR max  . Before and after the intervention, FMD was recorded with high-resolution Doppler ultrasound. Plasma levels of adropin and NOx were measured by enzyme-linked immunosorbent assay. After training FMD was significantly higher in the MICT and HIIT groups compared to the control group (P<0.05). Plasma levels of adropin and NOx were higher in both exercise groups, but the increase was greater in the HIIT group (P<0.01). Peak oxygen consumption was increased after exercise training in both groups compared to the control group (P<0.01). Percent FMD showed a positive correlation with plasma levels of adropin and NOx (both P<0.01), and a negative correlation with DBP (r = -0.530, P = 0.035) and SBP (r = -0.606, P = 0.013) in the HIIT group. The results indicate that HIIT improved FMD whilst increasing adropin, NOx and peak oxygen consumption. Increased plasma levels of adropin may contribute, in part, to blood pressure reduction by increasing nitric oxide production. This article is protected by copyright. All rights reserved.",2022,Peak oxygen consumption was increased after exercise training in both groups compared to the control group (P<0.01).,"['patients with type 2 diabetes', 'middle-aged and older healthy people', 'Sixty-six persons with type 2 diabetes', 'patients with type 2 diabetes at baseline and follow-up after 12 weeks of high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT', 'patients of this age with type 2 diabetes']","['MICT', 'Exercise training', 'High-intensity interval training', 'high-intensity interval training', 'MICT training']","['blood pressure and flow-mediated dilation', 'adropin and NOx plasma levels', 'FMD, and plasma levels of adropin and nitrite/nitrate (NOx', 'SBP', 'plasma levels of adropin and NOx', 'endothelial function, blood pressure and flow-mediated dilation', 'Plasma levels of adropin and NOx', 'Peak oxygen consumption', 'HIIT improved FMD whilst increasing adropin, NOx and peak oxygen consumption', 'blood pressure and flow-mediated dilation via increased plasma adropin and NOx']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",66.0,0.0107207,Peak oxygen consumption was increased after exercise training in both groups compared to the control group (P<0.01).,"[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Davoodi', 'Affiliation': 'Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Behnam Keshtkar', 'Initials': 'BK', 'LastName': 'Hesamabadi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Science, Shiraz University, Shiraz, Iran.'}, {'ForeName': 'Erfaneh', 'Initials': 'E', 'LastName': 'Ariabood', 'Affiliation': 'Department of exercise physiology, Faculty of Physical Education and Sports Sciences, University of Shahid Chamran, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Izadi', 'Affiliation': 'Department of exercise physiology, Faculty of Physical Education and Sports Sciences, University of Shahid Chamran, Ahvaz, Iran.'}, {'ForeName': 'Alireza Ghardashi', 'Initials': 'AG', 'LastName': 'Afousi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Sciences, University of Tehran.'}, {'ForeName': 'Mohammad Ali Babaee', 'Initials': 'MAB', 'LastName': 'Bigi', 'Affiliation': 'Cardiovascular Research Center, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Asvadi-Fard', 'Affiliation': 'Department of Medicine, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Exercise Sciences, University of Tehran, Tehran, Iran.'}]",Experimental physiology,['10.1113/EP089371']
2215,35712433,Marginal Bone Level and Bone Thickness Reduction in Delayed and Immediate Implant Placement Protocol 6 Months Post-loading: An Observational Clinical Prospective Study.,"Objectives


The aim of this prospective study was to assess marginal bone level (MBL), buccal and palatal bone thickness reduction (BTR) around implants in delayed and immediate placement protocols, 6 months after loading.
Materials and Methods


Twenty-four patients were assigned to two treatment groups, and treated with an immediate (Test) or delayed implant placement (Control). Baseline and 6 months post-loading periapical and Cone Beam Computed Tomography radiographs were used to measure mesial, distal, buccal, and palatal MBL change, and buccal and palatal BTR.
Results


There was no statistically significant difference between groups, in MBL change, mesially ( p  = 0.4220), distally ( p  = 0.774), buccally ( p  = 0.221), and palatally ( p  = 0.195). There was more MBL change on the buccal side than on the palatal side in both groups, control ( p  = 0.012) and test ( p  = 0.005). Buccal bone thickness decreased significantly in both groups, and at all four levels ( p  < 0.05). Buccal BTR was higher in test implants at 0, 2, and 4 mm ( p  = 0.005,  p  = 0.0018,  p  = 0.006) on the buccal side, and at 0 mm ( p  = 0.006) on the palatal side. Implant stability increased in both groups ( p  < 0.001). A positive correlation was found between insertion torque and stability in the control group ( p  = 0.024).
Conclusions


Within the study limitations, MBL changes occur around implants and are comparable between groups. More buccal than palatal MBL change occurs in both groups. Buccal BTR is higher in immediate cases. Implant stability augmented in both groups.
Clinical Relevance


This data call for additive therapy to compensate for the expected bone loss, particularly in esthetically demanding cases.
Trial Registration


ClinicalTrials.gov Identifier: NCT04346706 Registered 14 April 2020 - Retrospectively registered, http://www.clinicalTrials.gov.",2022,"Buccal BTR was higher in test implants at 0, 2, and 4 mm ( p  = 0.005,  p  = 0.0018,  p  = 0.006) on the buccal side, and at 0 mm ( p  = 0.006) on the palatal side.",['Registered 14 April 2020'],['immediate (Test) or delayed implant placement (Control'],"['insertion torque and stability', 'mesial, distal, buccal, and palatal MBL change, and buccal and palatal BTR', 'marginal bone level (MBL), buccal and palatal bone thickness reduction (BTR', 'Implant stability', 'MBL change', 'Marginal Bone Level and Bone Thickness Reduction', 'Buccal BTR', 'Buccal bone thickness']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",24.0,0.0408205,"Buccal BTR was higher in test implants at 0, 2, and 4 mm ( p  = 0.005,  p  = 0.0018,  p  = 0.006) on the buccal side, and at 0 mm ( p  = 0.006) on the palatal side.","[{'ForeName': 'Maroun', 'Initials': 'M', 'LastName': 'Dagher', 'Affiliation': 'Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University, Riad el Solh, P. O. Box: 11-5076, Beirut, 11072050 Lebanon.'}, {'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Mokbel', 'Affiliation': 'Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University, Riad el Solh, P. O. Box: 11-5076, Beirut, 11072050 Lebanon.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Aboukhalil', 'Affiliation': 'Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University, Riad el Solh, P. O. Box: 11-5076, Beirut, 11072050 Lebanon.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Ghosn', 'Affiliation': 'Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University, Riad el Solh, P. O. Box: 11-5076, Beirut, 11072050 Lebanon.'}, {'ForeName': 'Abdelrahman', 'Initials': 'A', 'LastName': 'Kassir', 'Affiliation': 'Department of Radiology, Faculty of Dental Medicine, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Naaman', 'Affiliation': 'Department of Periodontology, Faculty of Dental Medicine, Saint Joseph University, Riad el Solh, P. O. Box: 11-5076, Beirut, 11072050 Lebanon.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-021-01673-3']
2216,35712432,Does Biphasic Calcium Phosphate-Coated Surface Increase the Secondary Stability in Dental Implants? A Split-Mouth Study.,"Purpose


This study aimed to evaluate biphasic calcium phosphate coating (BCPC) on the secondary stability of dental implants compared to sand-blasted and acid-etched (SLA) implants.
Materials and Methods


This is a split-mouth study. Thirty subjects (20 males and ten females) underwent a dental implant procedure to replace mandibular first or second molars bilaterally. The subjects were randomly assigned to BCPC or SLA groups. The resonance frequency analysis measurements were performed two, four, six, and eight weeks after the implant placement.
Results


Sixty implants were placed in the two groups (30 implants per group). The mean ISQ was 52.26 ± 3.73 in group 1 and 50.21 ± 2.59 in group 2 on day 14 after the implant insertion, 63.20 ± 2.76 in group 1 and 58.80 ± 2.14 in group 2 on day 28, 72.30 ± 3.15 in group 1 and 64.53 ± 3.19 in group 2 on day 42, and 78.70 ± 1.56 in group 1 and 71.63 ± 3.22 in group 2 on day 56. The data analysis demonstrated significant differences between the two groups in terms of the mean ISQ at various evaluation times.
Conclusion


Regarding ISQ measurements, the secondary stability in BCPC implants may be higher compared to SLA implants in two months after implant insertion.",2022,"The mean ISQ was 52.26 ± 3.73 in group 1 and 50.21 ± 2.59 in group 2 on day 14 after the implant insertion, 63.20 ± 2.76 in group 1 and 58.80 ± 2.14 in group 2 on day 28, 72.30 ± 3.15 in group 1 and 64.53 ± 3.19 in group 2 on day 42, and 78.70 ± 1.56 in group 1 and 71.63 ± 3.22 in group 2 on day 56.",['Thirty subjects (20 males and ten females'],"['sand-blasted and acid-etched (SLA', 'biphasic calcium phosphate coating (BCPC', 'BCPC or SLA', 'dental implant procedure to replace mandibular first or second molars bilaterally']",['mean ISQ'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4759711', 'cui_str': 'Sand'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0210087', 'cui_str': 'hydroxyapatite-beta tricalcium phosphate'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0595806,"The mean ISQ was 52.26 ± 3.73 in group 1 and 50.21 ± 2.59 in group 2 on day 14 after the implant insertion, 63.20 ± 2.76 in group 1 and 58.80 ± 2.14 in group 2 on day 28, 72.30 ± 3.15 in group 1 and 64.53 ± 3.19 in group 2 on day 42, and 78.70 ± 1.56 in group 1 and 71.63 ± 3.22 in group 2 on day 56.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tabrizi', 'Affiliation': 'Oral and Maxillofacial surgery Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan Mirmohammad', 'Initials': 'HM', 'LastName': 'Sadeghi', 'Affiliation': 'Oral and Maxillofacial surgery Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kimia', 'Initials': 'K', 'LastName': 'Ghasemi', 'Affiliation': 'Oral and Maxillofacial surgery Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Khayati', 'Affiliation': 'Oral and Maxillofacial surgery Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Jafarian', 'Affiliation': 'Oral and Maxillofacial surgery Department, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01448-2']
2217,35712409,Are Embrasure Wires Effective and Reliable Method for Intraoperative Maxillomandibular Fixation in Mandibular Fractures?,"Purpose


Maxillomandibular fixation (MMF) is a basic and fundamental principle in the management of the maxillofacial trauma patients. Some fractures require only intraoperative MMF, during open reduction and internal fixation but not in the postoperative period. The present study was aimed to assess and compare the efficacy of embrasure wire with Erich arch bar as methods of intraoperative maxillomandibular fixation in the management of mandibular fractures.
Materials and Methods


The prospective randomized study was undertaken in 30 patients who required intraoperative maxillomandibular fixation for mandibular fractures. Patients were randomly divided into two groups of 15 each (Erich arch bar in Group A and embrasure wire in Group B). The preoperative assessment included evaluation of demographic data, fracture location, mechanism of injury, degree of displacement of fracture and occlusion. Intraoperative parameters assessed were the time consumed for the application of MMF technique, injury to the operator/assistant, injury to the patient, stability of MMF technique, incidence of glove perforations and the cost of the MMF device.
Results


The mean time required for MMF and incidence of glove perforation were significantly ( P  < 0.001) less in embrasure wire group than the Erich arch bar group. The MMF technique maintained stable occlusion during open reduction and internal fixation in both the groups.
Conclusion


Embrasure wire is an effective, reliable alternative form of intraoperative MMF, as needle-stick injury and time taken for placement were less as compared to the Erich arch bar group. However, Erich arch bar wiring is a versatile method and recommended where postoperative maxillomandibular fixation is also required.",2022,The mean time required for MMF and incidence of glove perforation were significantly ( P  < 0.001) less in embrasure wire group than the Erich arch bar group.,"['30 patients who required intraoperative maxillomandibular fixation for mandibular fractures', 'maxillofacial trauma patients']","['Maxillomandibular fixation (MMF', 'embrasure wire with Erich arch bar as methods of intraoperative maxillomandibular fixation']","['stability of MMF technique, incidence of glove perforations and the cost of the MMF device', 'mean time required for MMF and incidence of glove perforation', 'evaluation of demographic data, fracture location, mechanism of injury, degree of displacement of fracture and occlusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0376509', 'cui_str': 'Maxillomandibular Fixation'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0376509', 'cui_str': 'Maxillomandibular Fixation'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C1291062', 'cui_str': 'Embrasure'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0449413', 'cui_str': 'Mechanism of injury'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",30.0,0.0131508,The mean time required for MMF and incidence of glove perforation were significantly ( P  < 0.001) less in embrasure wire group than the Erich arch bar group.,"[{'ForeName': 'Tejinder', 'Initials': 'T', 'LastName': 'Kaur', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, GT Road, Amritsar, 143001 India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dhawan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, GT Road, Amritsar, 143001 India.'}, {'ForeName': 'Ramandeep Singh', 'Initials': 'RS', 'LastName': 'Bhullar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, GT Road, Amritsar, 143001 India.'}, {'ForeName': 'Sarika', 'Initials': 'S', 'LastName': 'Kapila', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, GT Road, Amritsar, 143001 India.'}, {'ForeName': 'Sakshi', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, GT Road, Amritsar, 143001 India.'}, {'ForeName': 'Ritika', 'Initials': 'R', 'LastName': 'Resham', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, GT Road, Amritsar, 143001 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-021-01528-x']
2218,35712404,Comparative Evaluation of Suture Versus Sutureless Surgery in Mandibular Third Molar Impactions.,"Purpose


The purpose of this study is to compare the suture versus sutureless surgery in impacted mandibular third molar and to evaluate the morbidity and complications associated with each technique.
Materials and Methods


A total of 50 patients with asymptomatic impacted mandibular third molars were randomly divided into two groups of 25 patients each. Radiographs were taken to assess the angulation and degree of eruption in the third molar. A small modified Szmyd, V-shaped flap was raised in all cases, and teeth were extracted. In Group I-Suture group (suture was used to close the flap), and in Group II-Sutureless group (no suture used to close the flap). The post-operative pain, swelling, trismus, haemorrhage, periodontal pocket, and alveolar osteitis were evaluated at 24 h, 48 h, 5th days, 7th days, and 2 weeks after surgery. The statistical analysis was done using the Chi-square "" t "" test and Independent Samples "" t "" test.
Observations and Results


Pain, swelling, and trismus were found to be significantly reduced especially in the immediate post-operative period in the sutureless group as compared to the suture group ( p  < 0.001). There were no incidences of intra-operative and post-operative haemorrhage in any case. Follow-up of all the patients showed that there was no difference in periodontal sequelae and alveolar osteitis.
Conclusions


Sutureless surgery with small flap was found to be less invasive, time-saving, and also a cost-effective method. This technique significantly reduced the early crucial phase of patient discomfort and demonstrates good results.",2022,There were no incidences of intra-operative and post-operative haemorrhage in any case.,"['50 patients with asymptomatic impacted mandibular third molars', 'Mandibular Third Molar Impactions']","['Suture group (suture was used to close the flap), and in Group II-Sutureless group (no suture used to close the flap', 'suture versus sutureless surgery', 'Suture Versus Sutureless Surgery']","['periodontal sequelae and alveolar osteitis', 'intra-operative and post-operative haemorrhage', 'post-operative pain, swelling, trismus, haemorrhage, periodontal pocket, and alveolar osteitis', 'Pain, swelling, and trismus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C4277643', 'cui_str': 'Sutureless Surgery'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0013240', 'cui_str': 'Alveolar periostitis'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",50.0,0.0112632,There were no incidences of intra-operative and post-operative haemorrhage in any case.,"[{'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, M.M. College of Dental Sciences and Research, Mullana, Ambala, Haryana 133203 India.'}, {'ForeName': 'Parveen', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, D. A.V. [C] Dental College, Yamuna Nagar, 135001 India.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Chhabra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, D. A.V. [C] Dental College, Yamuna Nagar, 135001 India.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Bali', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, D. A.V. [C] Dental College, Yamuna Nagar, 135001 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01459-z']
2219,35712259,Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study.,"Objective


To compare glycemic control and treatment preference in children with type 1 diabetes (T1D) using sensor augmented pump (SAP) with predictive low glucose suspend (SmartGuard ® ) or pump with independent intermittent scanning continuous glucose monitoring (iscCGM, Freestyle libre  ® ).
Methods


In this open label, cross-over study, children 6 to 14 years of age, treated with insulin pump for at least 6 months, were randomized to insulin pump and iscCGM ( A ) or SAP with SmartGuard ®  ( B ) for 5 weeks followed by 5 additional weeks. The difference in percentages of time in glucose target (TIT), (3.9 - 8.0 mmol/l), <3 mmol/l, > 8 and 10 mmol/l, were analyzed using linear mixed models during the final week of each arm and were measured by blinded CGM (IPro2 ® ).
Results


31 children (15 girls) finished the study. With sensor compliance > 60%, no difference in TIT was found, TIT:  A  37.86%; 95% CI [33.21; 42.51];  B  37.20%; 95% CI [32.59; 41.82]; < 3 mmol/l  A  2.27% 95% CI [0.71; 3.84]  B  1.42% 95% CI [-0.13; 2.97]; > 8 mmol/l  A  0.60% 95% CI [0.56, 0.67];  B  0.63% [0.56; 0.70]. One year after the study all participants were on CGM compared to 80.7% prior to the study, with a shift of 13/25 participants from iscCGM to SAP.
Conclusions


In this study, no significant difference in glycemic control was found whether treated with SAP (SmartGuard ® ) or pump with iscCGM. The decision of all families to continue with CGM after the study suggests a positive impact, with preference for SmartGuard ® .
Clinical Trial Registration


[clinicaltrials.gov], identifier NCT03103867.",2022,"In this study, no significant difference in glycemic control was found whether treated with SAP (SmartGuard ® ) or pump with iscCGM.","['31 children (15 girls) finished the study', 'children with type 1 diabetes (T1D) using', 'children 6 to 14 years of age, treated with insulin pump for at least 6 months']","['sensor augmented pump (SAP) with predictive low glucose suspend (SmartGuard ® ) or pump with independent intermittent scanning continuous glucose monitoring (iscCGM, Freestyle libre  ® ', 'Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment', 'insulin pump and iscCGM ( A ) or SAP with SmartGuard ®  ( B ', 'SAP (SmartGuard ® ']",['percentages of time in glucose target (TIT'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",31.0,0.121741,"In this study, no significant difference in glycemic control was found whether treated with SAP (SmartGuard ® ) or pump with iscCGM.","[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schierloh', 'Affiliation': 'Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.'}, {'ForeName': 'Gloria A', 'Initials': 'GA', 'LastName': 'Aguayo', 'Affiliation': 'Deep Digital Phenotyping Research Unit, Department of Precision Health, Luxembourg Institute of Health, Strassen, Luxembourg.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schritz', 'Affiliation': 'Competence Center for Methodology and Statistics, Luxembourg Institute of Health, Strassen, Luxembourg.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Fichelle', 'Affiliation': 'Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'De Melo Dias', 'Affiliation': 'Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.'}, {'ForeName': 'Michel T', 'Initials': 'MT', 'LastName': 'Vaillant', 'Affiliation': 'Competence Center for Methodology and Statistics, Luxembourg Institute of Health, Strassen, Luxembourg.'}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': 'Institute of Endocrinology, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Gies', 'Affiliation': 'Pediatric Endocrinology, KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'de Beaufort', 'Affiliation': 'Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.'}]",Frontiers in endocrinology,['10.3389/fendo.2022.870916']
2220,35712220,Capturing Sequences of Learners' Self-Regulatory Interactions With Instructional Material During Game-Based Learning Using Auto-Recurrence Quantification Analysis.,"Undergraduate students ( N  = 82) learned about microbiology with Crystal Island, a game-based learning environment (GBLE), which required participants to interact with instructional materials (i.e., books and research articles, non-player character [NPC] dialogue, posters) spread throughout the game. Participants were randomly assigned to one of two conditions:  full agency , where they had complete control over their actions, and  partial agency , where they were required to complete an ordered play-through of Crystal Island. As participants learned with Crystal Island, log-file and eye-tracking time series data were collected to pinpoint instances when participants interacted with instructional materials. Hierarchical linear growth models indicated relationships between eye gaze dwell time and (1) the type of representation a learner gathered information from (i.e., large sections of text, poster, or dialogue); (2) the ability of the learner to distinguish relevant from irrelevant information; (3) learning gains; and (4) agency. Auto-recurrence quantification analysis (aRQA) revealed the degree to which repetitive sequences of interactions with instructional material were random or predictable. Through hierarchical modeling, analyses suggested that greater dwell times and learning gains were associated with more predictable sequences of interaction with instructional materials. Results from hierarchical clustering found that participants with restricted agency and more recurrent action sequences had greater learning gains. Implications are provided for how learning unfolds over learners' time in game using a non-linear dynamical systems analysis and the extent to which it can be supported within GBLEs to design advanced learning technologies to scaffold self-regulation during game play.",2022,Auto-recurrence quantification analysis (aRQA) revealed the degree to which repetitive sequences of interactions with instructional material were random or predictable.,['Undergraduate students ( N  = 82'],"['learned about microbiology with Crystal Island, a game-based learning environment (GBLE), which required participants to interact with instructional materials (i.e., books and research articles, non-player character [NPC] dialogue, posters) spread throughout the game', 'Instructional Material']","['dwell times and learning gains', 'learning gains']","[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0025952', 'cui_str': 'Microbiology'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}]","[{'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.073671,Auto-recurrence quantification analysis (aRQA) revealed the degree to which repetitive sequences of interactions with instructional material were random or predictable.,"[{'ForeName': 'Daryn A', 'Initials': 'DA', 'LastName': 'Dever', 'Affiliation': 'School of Modeling, Simulation, and Training, University of Central Florida, Orlando, FL, United States.'}, {'ForeName': 'Mary Jean', 'Initials': 'MJ', 'LastName': 'Amon', 'Affiliation': 'School of Modeling, Simulation, and Training, University of Central Florida, Orlando, FL, United States.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Vrzáková', 'Affiliation': 'School of Computing, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Megan D', 'Initials': 'MD', 'LastName': 'Wiedbusch', 'Affiliation': 'School of Modeling, Simulation, and Training, University of Central Florida, Orlando, FL, United States.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Cloude', 'Affiliation': 'SoarTechnology, Inc., Orlando, FL, United States.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Azevedo', 'Affiliation': 'School of Modeling, Simulation, and Training, University of Central Florida, Orlando, FL, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2022.813677']
2221,35712212,Nudges for Judges: An Experiment on the Effect of Making Sentencing Costs Explicit.,"Judges are typically tasked to consider sentencing benefits but not costs. Previous research finds that both laypeople and prosecutors discount the costs of incarceration when forming sentencing attitudes, raising important questions about whether professional judges show the same bias during sentencing. To test this, we used a vignette-based experiment in which Minnesota state judges ( N  = 87) reviewed a case summary about an aggravated robbery and imposed a hypothetical sentence. Using random assignment, half the participants received additional information about plausible negative consequences of incarceration. As predicted, our results revealed a mitigating effect of cost exposure on prison sentence term lengths. Critically, these findings support the conclusion that policies that increase transparency in sentencing costs could reduce sentence lengths, which has important economic and social ramifications.",2022,"Critically, these findings support the conclusion that policies that increase transparency in sentencing costs could reduce sentence lengths, which has important economic and social ramifications.","['Minnesota state judges ( N \u2009=\u200987) reviewed a case summary about an aggravated robbery and imposed a hypothetical sentence', 'Nudges for Judges']",[],[],"[{'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",[],[],,0.0512537,"Critically, these findings support the conclusion that policies that increase transparency in sentencing costs could reduce sentence lengths, which has important economic and social ramifications.","[{'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Aharoni', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, GA, United States.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Kleider-Offutt', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, GA, United States.'}, {'ForeName': 'Sarah F', 'Initials': 'SF', 'LastName': 'Brosnan', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, GA, United States.'}, {'ForeName': 'Morris B', 'Initials': 'MB', 'LastName': 'Hoffman', 'Affiliation': 'Retired, Second Judicial District, Denver, CO, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2022.889933']
2222,35712651,Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion.,"Objective


To compare the efficacy and safety of a fixed dose combination of Fluticasone Furoate and Oxymetazoline Hydrochloride Nasal Spray 27.5/50 mcg (FDC) with Fluticasone Furoate Nasal Spray 27.5 mcg (Fluticasone) in the management of allergic rhinitis.
Patients and Methods


A prospective, randomized, double-blind, two-arm, active-controlled, parallel, multicenter, comparative clinical study was conducted in patients with allergic rhinitis aged 18 years and above having moderate-to-severe nasal congestion.
Results


A total of 250 patients were randomized (1:1) to receive either the FDC or Fluticasone alone in a dose of two sprays in each nostril once daily at night. There was a significantly ( P <0.001) greater reduction in night-time Total Nasal Symptom Score with the FDC as compared to Fluticasone at all the time points starting from as early as day 3 and sustained till the end of treatment (Day 28) (Day 3: -3.1 vs -2.2; Day 7: -4.0 vs -3.4; Day 14: -5.7 vs -5.0; Day 28: -7.0 vs -6.4). A significantly greater number of patients ( P <0.05) had complete relief in Nasal Congestion with the FDC (44.7%) as compared to Fluticasone (26.8%). Both the study medications were well tolerated by all the patients. The proportion of patients showing worsening of symptoms (rebound congestion/rhinitis medicamentosa) after stoppage of medication was similar in both groups ( P >0.05).
Conclusion


The FDC was superior to Fluticasone alone in relieving the nasal congestion and reduction of Total Nasal Symptom Score in allergic rhinitis patients with moderate-to-severe nasal congestion when administered once daily in the evening. Oxymetazoline when used along with the nasal steroid in a once daily dose does not cause rebound congestion and rhinitis medicamentosa even after long-term continuous use of 28 days.",2022,The FDC was superior to Fluticasone alone in relieving the nasal congestion and reduction of Total Nasal Symptom Score in allergic rhinitis patients with moderate-to-severe nasal congestion when administered once daily in the evening.,"['allergic rhinitis patients with moderate-to-severe nasal congestion', 'patients with allergic rhinitis aged 18 years and above having moderate-to-severe nasal congestion', 'A total of 250 patients', 'Allergic Rhinitis with Nasal Congestion']","['Fluticasone Furoate and Oxymetazoline Nasal Spray', 'Fluticasone Furoate and Oxymetazoline Hydrochloride', 'Oxymetazoline', 'FDC or Fluticasone', 'Nasal Spray 27.5/50 mcg (FDC) with Fluticasone Furoate Nasal Spray 27.5 mcg (Fluticasone', 'Fluticasone']","['tolerated', 'efficacy and safety', 'night-time Total Nasal Symptom Score', 'Efficacy and Safety', 'complete relief in Nasal Congestion', 'nasal congestion and reduction of Total Nasal Symptom Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C1235834', 'cui_str': 'Oxymetazoline Nasal Spray [Afrin]'}, {'cui': 'C0357797', 'cui_str': 'Oxymetazoline hydrochloride'}, {'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}, {'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C4517674', 'cui_str': '27.5'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",250.0,0.053112,The FDC was superior to Fluticasone alone in relieving the nasal congestion and reduction of Total Nasal Symptom Score in allergic rhinitis patients with moderate-to-severe nasal congestion when administered once daily in the evening.,"[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Kumar', 'Affiliation': 'Department of Pulmonary Medicine, Government Medical College & Government General Hospital, Srikakulam, India.'}, {'ForeName': 'Manish Kumar', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'Department of Pulmonary Medicine, Maharaja Agrasen Superspeciality Hospital, Jaipur, India.'}, {'ForeName': 'Jitendra Singh', 'Initials': 'JS', 'LastName': 'Kushwaha', 'Affiliation': 'Department of Medicine, Prakhar Hospital Pvt. Ltd, Kanpur, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Department of ENT, Jeevan Rekha Hospital, Belgavi, India.'}, {'ForeName': 'Vasanti', 'Initials': 'V', 'LastName': 'Patil', 'Affiliation': 'Department of ENT, Rajarshi Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur, India.'}, {'ForeName': 'Soumya', 'Initials': 'S', 'LastName': 'Ghatak', 'Affiliation': 'Department of ENT, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Sanmukhani', 'Affiliation': 'Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited, Ahmedabad, India.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Mittal', 'Affiliation': 'Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited, Ahmedabad, India.'}]",Journal of asthma and allergy,['10.2147/JAA.S357288']
2223,35712635,Softer More Frequent Stools in Infants With Difficult Stooling Fed Hydrolyzed Protein Formula With Added Prebiotics: Randomized Controlled Trial.,"Objective


To evaluate stool consistency in infants with reported hard or infrequent stools fed hydrolyzed protein formula with added prebiotics designed to promote stool softening.
Methods


In this multi-center, double-blind, controlled study, eligible infants (28-300 days of age at enrollment) were randomized to: partially hydrolyzed cow's milk protein formula (PHF, 75% carbohydrate as lactose; 12 mg Mg/100 kcal;  n  = 49) or routine intact protein cow's milk-based infant formula (Control, 92% carbohydrate as lactose; 8 mg Mg/100 kcal;  n  = 51) over a 14-day period. Both formulas had a prebiotic blend (polydextrose and galactooligosaccharides, 4 g/L; 1:1 ratio). Parent-reported stool consistency (hard = 1 through watery = 5) and other daily outcomes were collected by diary. Endpoint stool consistency (mean score over last 3 days of study feeding) was the primary outcome. Adverse events were recorded.
Results


Baseline stool consistency (Control: 1.4 ± 0.1, PHF: 1.4 ± 0.1) and frequency were similar between groups; the majority had hard ( n  = 61, 64%) or formed ( n  = 30, 32%) stools. Stool consistency became softer over Day 1-3 (Control: 2.5 ± 0.1, PHF: 2.6 ± 0.1) and remained similar from Day 4 to 6 through study end ( post hoc  analysis). For PHF vs Control, endpoint stool consistency was significantly softer (3.4 ± 0.1 vs 3.0 ± 0.1;  P  = 0.019) and frequency significantly higher (1.5 ± 0.1 vs 1.0 ± 0.1;  P  = 0.002). Crying, fussing, and appearance of pain during stooling decreased from baseline to study end in both groups. Formula intake, infant fussiness and incidence of adverse events were similar between groups.
Conclusion


An infant formula designed to promote stool softening was well-tolerated and associated with softer, more frequent stools in infants with reported hard or infrequent stools.",2022,"An infant formula designed to promote stool softening was well-tolerated and associated with softer, more frequent stools in infants with reported hard or infrequent stools.","['eligible infants (28-300 days of age at enrollment', 'infants with reported hard or infrequent stools fed hydrolyzed protein formula with added prebiotics designed to promote stool softening']","[""partially hydrolyzed cow's milk protein formula (PHF, 75% carbohydrate as lactose; 12 mg Mg/100 kcal;  n  = 49) or routine intact protein cow's milk-based infant formula (Control, 92% carbohydrate as lactose"", 'prebiotic blend (polydextrose and galactooligosaccharides']","['Endpoint stool consistency', 'Adverse events', 'Crying, fussing, and appearance of pain during stooling', 'Formula intake, infant fussiness and incidence of adverse events']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C3853229', 'cui_str': 'Hydrolyzed protein formula'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0440448', 'cui_str': ""Cow's milk protein""}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}]","[{'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.120773,"An infant formula designed to promote stool softening was well-tolerated and associated with softer, more frequent stools in infants with reported hard or infrequent stools.","[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Fabrizio', 'Affiliation': 'Medical and Scientific Affairs, Reckitt | Mead Johnson Nutrition Institute (MJNI), Evansville, IN, United States.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Harris', 'Affiliation': 'Medical and Scientific Affairs, Reckitt | Mead Johnson Nutrition Institute (MJNI), Evansville, IN, United States.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Walsh', 'Affiliation': 'Medical and Scientific Affairs, Reckitt | Mead Johnson Nutrition Institute (MJNI), Evansville, IN, United States.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wampler', 'Affiliation': 'Medical and Scientific Affairs, Reckitt | Mead Johnson Nutrition Institute (MJNI), Evansville, IN, United States.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'Medical and Scientific Affairs, Reckitt | Mead Johnson Nutrition Institute (MJNI), Evansville, IN, United States.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Medical and Scientific Affairs, Reckitt | Mead Johnson Nutrition Institute (MJNI), Evansville, IN, United States.'}]",Frontiers in pediatrics,['10.3389/fped.2022.894626']
2224,35712945,[Effect of  Wei 's triple nine needling on eye regulation in patients with presbyopia complicated with visual fatigue of liver depression and spleen deficiency].,"OBJECTIVE


To compare the clinical efficacy between  Wei 's triple nine needling combined with  esculin  and  digitalis  glycosides eye drops and  esculin  and  digitalis  glycosides eye drops alone for presbyopia complicated with visual fatigue of liver depression and spleen deficiency.
METHODS


Forty-six cases (92 eyes) with presbyopia complicated with visual fatigue of liver depression and spleen deficiency were randomly divided into an observation group (23 cases) and a control group (23 cases, 2 cases dropped off). The cases in the observation group were treated with  Wei 's triple nine needling and  esculin  and  digitalis  glycosides eye drops. The acupoints included Shangming (Extra), Chengqi (ST 1), Cuanzhu (BL 2) to Jingming (BL 1), Sizhukong (TE 23) to Taiyang (EX-HN 5), etc; the needling was given once every other day, three times a week, and the eye drops were given one drop each time, three times a day. The cases in the control group were only treated with the eye drops. Both groups were treated for 7 days as one course of treatment, and 2 courses of treatment were given. The visual fatigue core symptoms score, adjustment amplitude, adjustment lag and best average corrected visual acuity were observed in the two groups before treatment, 1 week and 2 weeks into treatment, respectively.
RESULTS


Compared before treatment, the visual fatigue core symptoms scores in the two groups were decreased after 1-week and 2-week treatment ( P <0.05); in the observation group, the adjustment amplitude was increased after 2-week treatment ( P <0.05), while in the control group, the adjustment amplitude was increased after 1-week and 2-week treatment ( P <0.05); in the observation group, the adjustment lag was decreased after 1-week and 2-week treatment ( P <0.05). After 2-week treatment, the visual fatigue core symptoms score in the observation group was lower than that in the control group, and the adjustment amplitude was higher than that in the control group ( P <0.05). There were no significant differences in adjustment lag and best average corrected visual acuity between the two groups after 1-week and 2-week treatment ( P >0.05).
CONCLUSION


Wei 's triple nine needling combined with  esculin  and  digitalis  glycosides eye drops could improve the visual fatigue and eye regulation ability in patients with presbyopia complicated with visual fatigue of liver depression and spleen deficiency, and the effect is better than  esculin  and  digitalis  glycosides eye drops alone.",2022,"There were no significant differences in adjustment lag and best average corrected visual acuity between the two groups after 1-week and 2-week treatment ( P >0.05).
","['patients with presbyopia complicated with visual fatigue of liver depression and spleen deficiency', 'presbyopia complicated with visual fatigue of liver depression and spleen deficiency', 'Forty-six cases (92 eyes) with presbyopia complicated with visual fatigue of liver depression and spleen deficiency']","[""Wei 's triple nine needling and  esculin  and  digitalis  glycosides eye drops"", ""Wei 's triple nine needling""]","['visual fatigue core symptoms score', 'visual fatigue core symptoms scores', 'adjustment lag and best average corrected visual acuity', 'visual fatigue and eye regulation ability', 'visual fatigue core symptoms score, adjustment amplitude, adjustment lag and best average corrected visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033075', 'cui_str': 'Presbyopia'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0014839', 'cui_str': 'Esculin'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0255679,"There were no significant differences in adjustment lag and best average corrected visual acuity between the two groups after 1-week and 2-week treatment ( P >0.05).
","[{'ForeName': 'Tao-Tao', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': 'Ophthalmology Department of Henan Hospital of TCM, Zhengzhou 450002, China.'}, {'ForeName': 'Ting-Heng', 'Initials': 'TH', 'LastName': 'Jin', 'Affiliation': 'Ophthalmology Department of Henan Hospital of TCM, Zhengzhou 450002, China.'}, {'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Xia', 'Affiliation': 'Ophthalmology Department of Dongfang Hospital of Beijing University of CM, Beijing 100078.'}, {'ForeName': 'Qi-Ping', 'Initials': 'QP', 'LastName': 'Wei', 'Affiliation': 'Ophthalmology Department of Dongfang Hospital of Beijing University of CM, Beijing 100078.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Ophthalmology Department of Dongfang Hospital of Beijing University of CM, Beijing 100078.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Xiao', 'Affiliation': 'Ophthalmology Department of Dongfang Hospital of Beijing University of CM, Beijing 100078.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': 'Ophthalmology Department of Dongfang Hospital of Beijing University of CM, Beijing 100078.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20210617-k0002']
2225,35712944,[Effect of transcutaneous auricular vagus nerve stimulation on nocturnal autonomic nervous function in primary insomnia patients].,"OBJECTIVE


To observe the effect of transcutaneous auricular vagus nerve stimulation (taVNS) on the sleep quality and nocturnal heart rate variability (HRV) in patients with primary insomnia.
METHODS


Twenty-one patients with primary insomnia were included. Using SDZ-ⅡB electric acupuncture apparatus, Xin (CO 15 ) and Shen (CO 10 ) were stimulated with disperse-dense wave, 4 Hz/ 20 Hz in frequency, (0.2±30%) ms of pulse width and tolerable intensity. Electric stimulation was given once every morning and evening of a day, 30 min each time, for 4 weeks totally. Before and after treatment, the score of Pittsburgh sleep quality index (PSQI), objective sleep structure (total sleep time [TST], sleep latency [SL], wake after sleep onset [WASO], sleep efficiency [SE], the percentages of non-rapid eye movement period 1, 2, 3, and the percentage of rapid eye movement period to TST [N1%, N2%, N3%, REM%] ) and nocturnal HRV (high frequency [HF], low frequency [LF], the ratio of LF to HF [LF/HF], standard deviation for the normal RR intervals [SDNN], squared root of the mean sum of squares of differences between adjacent intervals RR [RMSSD], the percentage of adjacent RR intervals with differences larger than 50 ms in the entire recording [PNN50%], the mean of sinus RR intervals [NNMean] ) were compared in the patients separately.
RESULTS


After treatment, the score of each item and the total score of PSQI and SL were all reduced as compared with those before treatment ( P <0.01,  P <0.001); SE, N3%, LF, HF, LF/HF, SDNN, NNMean and RMSSD were all increased compared with those before treatment ( P <0.001,  P <0.01).
CONCLUSION


The taVNS improves the sleep quality and objective sleep structure in patients with primary insomnia, which is probably related to the regulation of autonomic nervous functions.",2022,"Before and after treatment, the score of Pittsburgh sleep quality index (PSQI), objective sleep structure (total sleep time [TST], sleep latency [SL], wake after sleep onset [WASO], sleep efficiency [SE], the percentages of non-rapid eye movement period 1, 2, 3, and the percentage of rapid eye movement period to TST [N1%, N2%, N3%, REM%] ) and nocturnal HRV (high frequency [HF], low frequency [LF], the ratio of LF to HF [LF/HF], standard deviation for the normal RR intervals [SDNN], squared root of the mean sum of squares of differences between adjacent intervals RR [RMSSD], the percentage of adjacent RR intervals with differences larger than 50 ms in the entire recording [PNN50%], the mean of sinus RR intervals [NNMean] ) were compared in the patients separately.
","['primary insomnia patients', 'patients with primary insomnia', 'Twenty-one patients with primary insomnia were included']","['Electric stimulation', 'transcutaneous auricular vagus nerve stimulation (taVNS', 'taVNS', 'transcutaneous auricular vagus nerve stimulation', 'SDZ-ⅡB electric acupuncture apparatus, Xin (CO 15 ) and Shen (CO 10 ) were stimulated with disperse-dense wave, 4 Hz']","['total score of PSQI and SL', 'score of Pittsburgh sleep quality index (PSQI), objective sleep structure (total sleep time [TST], sleep latency [SL], wake after sleep onset [WASO], sleep efficiency [SE], the percentages of non-rapid eye movement period 1, 2, 3, and the percentage of rapid eye movement period to TST [N1%, N2%, N3%, REM%] ) and nocturnal HRV (high frequency [HF], low frequency [LF], the ratio of LF to HF [LF/HF], standard deviation for the normal RR intervals [SDNN], squared root of the mean sum of squares of differences between adjacent intervals RR [RMSSD', 'sleep quality and nocturnal heart rate variability (HRV', 'pulse width and tolerable intensity', 'nocturnal autonomic nervous function', 'sleep quality and objective sleep structure', 'mean of sinus RR intervals [NNMean] ', 'LF, HF, LF/HF, SDNN, NNMean and RMSSD', 'percentage of adjacent RR intervals']","[{'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C1268558', 'cui_str': 'Oxygen (15-O) carbon monoxide'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]",21.0,0.0616104,"Before and after treatment, the score of Pittsburgh sleep quality index (PSQI), objective sleep structure (total sleep time [TST], sleep latency [SL], wake after sleep onset [WASO], sleep efficiency [SE], the percentages of non-rapid eye movement period 1, 2, 3, and the percentage of rapid eye movement period to TST [N1%, N2%, N3%, REM%] ) and nocturnal HRV (high frequency [HF], low frequency [LF], the ratio of LF to HF [LF/HF], standard deviation for the normal RR intervals [SDNN], squared root of the mean sum of squares of differences between adjacent intervals RR [RMSSD], the percentage of adjacent RR intervals with differences larger than 50 ms in the entire recording [PNN50%], the mean of sinus RR intervals [NNMean] ) were compared in the patients separately.
","[{'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Zhao', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Shao-Yuan', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Su-Xia', 'Initials': 'SX', 'LastName': 'Li', 'Affiliation': 'National Institute on Drug Dependence, Peking University.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Jia-Kai', 'Initials': 'JK', 'LastName': 'He', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Pei-Jing', 'Initials': 'PJ', 'LastName': 'Rong', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20210622-k0006']
2226,35712943,[Treatment of finger spasm after stroke with wheat grain moxibustion at Shixuan (EX-UE 11) combined with rehabilitation training: a randomized controlled trial].,"OBJECTIVE


To compare the clinical effect of wheat grain moxibustion combined with rehabilitation training and simple rehabilitation training on finger spasm after stroke.
METHODS


A total of 80 patients with finger spasm after stroke were randomly divided into an observation group and a control group, 40 cases in each group. The control group was given routine rehabilitation training, once a day, 30 min each time. The observation group was given wheat grain moxibustion at Shixuan (EX-UE 11) on the basis of the control group, 8~10 moxibustion cones at each point, once a day. Both groups were treated for 6 days as one course of treatment for 4 courses. The motor function of the affected hand (Fugl-Meyer assessment [FMA] score) and muscle tension (modified Ashworth scale [MAS] grading), surface EMG indexes (wrist dorsiflexor muscle and flexor carpal metacarpal muscle mean square [RMS] value), hand muscle strength (neurological deficit score [NDS]) and daily living ability (modified Barthel index [MBI] score) were compared between the two groups before and after treatment, and clinical efficacy was evaluated.
RESULTS


After treatment, FMA and MBI scores in the 2 groups were increased compared with before treatment ( P <0.05), and those in the observation group were higher than the control group ( P <0.05). The RMS value of wrist dorsiflexor muscle and flexor carpal metacarpal muscle in relaxation and passive function testsand and NDS in the 2 groups were lower than those before treatment ( P <0.05), and those in the observation group were lower than the control group ( P <0.05). MAS grading in the 2 groups was improved compared with before treatment ( P <0.05), and that in the observation group was better than the control group ( P <0.05). The total effective rate of the observation group was 92.5% (37/40), which was higher than that of the control group (80.0%, 32/40,  P <0.05).
CONCLUSION


Wheat grain moxibustion at Shixuan (EX-UE 11) combined with rehabilitation training can improve the hand motor function and daily living ability of patients with finger spasm after stroke, improve the degree of spasm and the function of wrist dorsiflexor muscle and flexor carpal metacarpal muscle, the clinical effect is better than simple rehabilitation training.",2022,"After treatment, FMA and MBI scores in the 2 groups were increased compared with before treatment ( P <0.05), and those in the observation group were higher than the control group ( P <0.05).","['finger spasm after stroke', 'patients with finger spasm after stroke', '80 patients with finger spasm after stroke']","['wheat grain moxibustion', 'routine rehabilitation training', 'wheat grain moxibustion at Shixuan (EX-UE 11) combined with rehabilitation training', 'Wheat grain moxibustion at Shixuan (EX-UE 11) combined with rehabilitation training', 'wheat grain moxibustion combined with rehabilitation training and simple rehabilitation training']","['total effective rate', 'RMS value of wrist dorsiflexor muscle and flexor carpal metacarpal muscle in relaxation and passive function testsand and NDS', 'motor function of the affected hand (Fugl-Meyer assessment [FMA] score) and muscle tension (modified Ashworth scale [MAS] grading), surface EMG indexes (wrist dorsiflexor muscle and flexor carpal metacarpal muscle mean square [RMS] value), hand muscle strength (neurological deficit score [NDS]) and daily living ability (modified Barthel index [MBI] score', 'FMA and MBI scores', 'MAS grading', 'clinical efficacy']","[{'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007285', 'cui_str': 'Bone structure of carpus'}, {'cui': 'C0025526', 'cui_str': 'Metacarpal bone structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0581668', 'cui_str': 'Muscle structure of hand'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",80.0,0.0200699,"After treatment, FMA and MBI scores in the 2 groups were increased compared with before treatment ( P <0.05), and those in the observation group were higher than the control group ( P <0.05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Niu', 'Affiliation': 'Henan University of TCM, Zhengzhou 450046, China.'}, {'ForeName': 'Yan-Jie', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Henan Provincial Hospital of TCM, Second Affiliated Hospital of Henan University of TCM, Zhengzhou 450002.'}, {'ForeName': 'He-Wei', 'Initials': 'HW', 'LastName': 'Qin', 'Affiliation': 'Henan Provincial Hospital of TCM, Second Affiliated Hospital of Henan University of TCM, Zhengzhou 450002.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': 'Henan University of TCM, Zhengzhou 450046, China.'}, {'ForeName': 'Hao-Yuan', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'Henan University of TCM, Zhengzhou 450046, China.'}, {'ForeName': 'Xiao-Qiong', 'Initials': 'XQ', 'LastName': 'Hua', 'Affiliation': 'Henan University of TCM, Zhengzhou 450046, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Zhang', 'Affiliation': 'Henan University of TCM, Zhengzhou 450046, China.'}, {'ForeName': 'Yu-Bin', 'Initials': 'YB', 'LastName': 'Sun', 'Affiliation': 'Henan University of TCM, Zhengzhou 450046, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20210611-0001']
2227,35712942,[Acupuncture for perimenopausal early-wake insomnia: a randomized controlled trial].,"OBJECTIVE


To observe the clinical effect of acupuncture for perimenopausal early-wake insomnia.
METHODS


A total of 60 patients with perimenopausal early-wake insomnia were randomly divided into an observation group (30 cases, 3 cases dropped off) and a control group (30 cases, 2 cases dropped off, 2 cases were removed). In the observation group, acupuncture was applied at Baihui (GV 20), Yintang (GV 24 + ), Anmian (Extra), Hegu (LI 4), Shenmen (HT 7), Taichong (LR 3), Taixi (KI 3), etc., once every other day, 3 times a week. In the control group, oryzanol tablets were taken orally, 20 mg each time, 3 times a day. Both groups were treated for 4 weeks. Before and after treatment, the sleep actigraphy (ACT) was used to measure the effective sleep time, sleep quality, wake-up time, wake-up frequency, each wake-up time, and the Pittsburgh sleep quality index (PSQI) score and early-wake score were compared in the two groups, and the clinical effect was assessed.
RESULTS


After treatment, compared before treatment, the effective sleep time was prolonged and the sleep quality was improved ( P <0.05), the wake-up time, each wake-up time were shortened and wake-up frequency was decreased ( P <0.05), the PSQI score and early-wake score were decreased ( P <0.05) in the observation group. After treatment, the wake-up frequency, PSQI score and early-wake score were decreased in the control group ( P <0.05). The effective sleep time, sleep quality, wake-up time, wake-up frequency, each wake-up time, PSQI score and early-wake score after treatment in the observation group were superior to the control group ( P <0.05). The total effective rate was 88.9% (24/27) in the observation group, which was higher than 38.5% (10/26) in the control group ( P <0.05).
CONCLUSION


Acupuncture can increase the effective sleep time and improve sleep quality in patients with perimenopausal early-wake insomnia.",2022,"After treatment, the wake-up frequency, PSQI score and early-wake score were decreased in the control group ( P <0.05).","['60 patients with perimenopausal early-wake insomnia', 'patients with perimenopausal early-wake insomnia', 'perimenopausal early-wake insomnia']","['Acupuncture', 'oryzanol tablets', 'acupuncture']","['total effective rate', 'PSQI score and early-wake score', 'effective sleep time, sleep quality, wake-up time, wake-up frequency, each wake-up time, and the Pittsburgh sleep quality index (PSQI) score and early-wake score', 'effective sleep time', 'sleep quality', 'effective sleep time, sleep quality, wake-up time, wake-up frequency, each wake-up time, PSQI score and early-wake score', 'sleep actigraphy (ACT', 'wake-up time, each wake-up time were shortened and wake-up frequency', 'wake-up frequency, PSQI score and early-wake score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0541798', 'cui_str': 'Terminal insomnia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0061081', 'cui_str': 'gamma-oryzanol'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0541798', 'cui_str': 'Terminal insomnia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}]",60.0,0.0196101,"After treatment, the wake-up frequency, PSQI score and early-wake score were decreased in the control group ( P <0.05).","[{'ForeName': 'Jian-Fang', 'Initials': 'JF', 'LastName': 'Zhu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou 310053.'}, {'ForeName': 'Ji-Li', 'Initials': 'JL', 'LastName': 'Sheng', 'Affiliation': 'Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou 310053.'}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Jin', 'Affiliation': 'Department of Acupuncture and Moxibustion, Zhejiang Hospital, Hangzhou 310013, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20211009-k0004']
2228,35712941,[Acupuncture at sphenopalatine ganglion combined with conventional acupuncture for episodic cluster headache: a randomized controlled trial].,"OBJECTIVE


To observe the clinical effect of acupuncture at sphenopalatine ganglion combined with conventional acupuncture for episodic cluster headache (CH).
METHODS


One hundred and eighty patients with episodic CH were randomly divided into a combined group (60 cases, 3 cases dropped off)，an acupuncture group (60 cases, 2 cases dropped off) and a sphenopalatine ganglion group (60 cases, 2 cases dropped off and 1 case was removed). The patients in the acupuncture group were treated with conventional acupuncture at Touwei (ST 8), Yintang (GV 24 + ), Yangbai (GB 14), Hegu (LI 4), etc., once a day, 6 times a week. The patients in the sphenopalatine ganglion group were treated with acupuncture at sphenopalatine ganglion, once every other day, 3 times a week. On the basis of the conventional acupuncture, the combined group was treated with acupuncture at sphenopalatine ganglion once every other day. Two weeks were taken as a course of treatment, and 3 courses of treatment were required in the 3 groups. The score of visual analogue scale (VAS), the number of headache attacks per week, the duration of each headache attack and the score of migraine-specific quality of life questionnaire version 2.1 (MSQ) were observed before and after treatment and in follow-up of 3 months after treatment. The clinical efficacy of each group was compared.
RESULTS


After treatment and in follow-up, the VAS score of headache, the number of headache attacks per week, the duration of each headache attack, and each various scores and the total score of MSQ of each group were lower than those before treatment ( P <0.01). Except that the number of headache attacks per week in the combined group was lower than the sphenopalatine ganglion group ( P <0.01), other indexes in the combined group were lower than the other two groups ( P <0.05,  P <0.01). The total effective rate in the combined group was 93.0% (53/57), which was higher than 75.9% (44/58) in the acupuncture group and 73.7% (42/57) in the sphenopalatine ganglion group（ P <0.05,  P <0.01).
CONCLUSION


Acupuncture at sphenopalatine ganglion combined with conventional acupuncture could reduce the degree of pain in patients with episodic CH, reduce the number and duration of headache attacks, and improve the quality of life of patients. It is more effective than simple conventional acupuncture or acupuncture at sphenopalatine ganglion alone.",2022,"Except that the number of headache attacks per week in the combined group was lower than the sphenopalatine ganglion group ( P <0.01), other indexes in the combined group were lower than the other two groups ( P <0.05,  P <0.01).","['episodic cluster headache', 'episodic cluster headache (CH', 'One hundred and eighty patients with episodic CH', 'patients with episodic CH']","['conventional acupuncture at Touwei (ST 8), Yintang (GV 24 + ), Yangbai (GB 14), Hegu (LI 4), etc', 'acupuncture', 'sphenopalatine ganglion', 'acupuncture at sphenopalatine ganglion combined with conventional acupuncture', 'conventional acupuncture', 'acupuncture at sphenopalatine ganglion', 'Acupuncture at sphenopalatine ganglion combined with conventional acupuncture']","['total effective rate', 'VAS score of headache, the number of headache attacks per week, the duration of each headache attack, and each various scores and the total score of MSQ', 'score of visual analogue scale (VAS), the number of headache attacks per week, the duration of each headache attack and the score of migraine-specific quality of life questionnaire version 2.1 (MSQ', 'degree of pain', 'quality of life', 'number of headache attacks', 'number and duration of headache attacks']","[{'cui': 'C0393739', 'cui_str': 'Episodic cluster headache'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0450834', 'cui_str': 'Yintang'}, {'cui': 'C0229062', 'cui_str': 'Structure of sphenopalatine ganglion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",180.0,0.0638153,"Except that the number of headache attacks per week in the combined group was lower than the sphenopalatine ganglion group ( P <0.01), other indexes in the combined group were lower than the other two groups ( P <0.05,  P <0.01).","[{'ForeName': 'Feng-Lei', 'Initials': 'FL', 'LastName': 'Zai', 'Affiliation': 'Department of Acupuncture-Moxibustion and Physiotherapy, Heping Hospital Affiliated to Changzhi Medical College, Changzhi 046000, Shanxi Province, China.'}, {'ForeName': 'Lai-Xi', 'Initials': 'LX', 'LastName': 'Ji', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Shanxi University of CM, Taiyuan 030024.'}, {'ForeName': 'Jiang-Hui', 'Initials': 'JH', 'LastName': 'Cheng', 'Affiliation': 'Department of Acupuncture-Moxibustion and Physiotherapy, Heping Hospital Affiliated to Changzhi Medical College, Changzhi 046000, Shanxi Province, China.'}, {'ForeName': 'Ya-Ru', 'Initials': 'YR', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture-Moxibustion and Physiotherapy, Heping Hospital Affiliated to Changzhi Medical College, Changzhi 046000, Shanxi Province, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture-Moxibustion and Physiotherapy, Heping Hospital Affiliated to Changzhi Medical College, Changzhi 046000, Shanxi Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20211111-k0007']
2229,35712916,Guided Self-Help for Pediatric Obesity in Primary Care: A Randomized Clinical Trial.,"
OBJECTIVES


Our aim was to compare the effect of 2 treatment models on attendance and child weight status: a less intense guided self-help (GSH) program delivered in the primary care setting versus traditional family-based behavioral treatment (FBT) delivered in an academic center.
METHODS


We conducted a randomized clinical trial among 164 children between 5 and 13 years old with a BMI ≥85th percentile and their parents. The intervention group (GSH) received 14 individual sessions over 6 months, with 5.3 hours of treatment. The control group (FBT) received 20 group-based sessions over 6 months, with 20 hours of treatment. Main outcomes included proportion of sessions families attended and change in child BMI z-score (BMIz), percentage from the 95th BMI percentile, difference from the 95th BMI percentile at the end of treatment, and 6-month follow-up.
RESULTS


Mean age of children was 9.6 years, BMI z-score 2.1, 49% female, and >90% Latino. The odds of attending GSH compared to FBT was 2.2 (P < 0.01). Those assigned to GSH had a 67% reduced risk of attrition (hazard ratio = 0.33, 95% confidence interval 0.22-0.50, P < .001). Intent-to-treat analysis showed no between-group differences in change in BMIz and percentage from the 95th BMI percentile over time. Combined, there was a significant reduction in BMIz from baseline to posttreatment (β = -0.07 (0.01), P < .01, d: 0.60) and a slight increase from posttreatment to follow-up (β = 0.007 (0.13), P = .56).
CONCLUSIONS


This study provides support for a novel, less intense GSH model of obesity treatment, which can be implemented in the primary care setting. Future studies should examine effective approaches to dissemination and implementation of GSH in different settings to increase access to treatment.",2022,"Those assigned to GSH had a 67% reduced risk of attrition (hazard ratio = 0.33, 95% confidence interval 0.22-0.50, P < .001).","['164 children between 5 and 13 years old with a BMI ≥85th percentile and their parents', 'Mean age of children was 9.6 years, BMI z-score 2.1, 49% female, and >90% Latino', 'Pediatric Obesity in Primary Care']","['GSH', 'guided self-help (GSH) program delivered in the primary care setting versus traditional family-based behavioral treatment (FBT', 'Guided Self-Help']","['BMIz', 'attendance and child weight status', 'proportion of sessions families attended and change in child BMI z-score (BMIz), percentage from the 95th BMI percentile, difference from the 95th BMI percentile', 'risk of attrition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",164.0,0.104234,"Those assigned to GSH had a 67% reduced risk of attrition (hazard ratio = 0.33, 95% confidence interval 0.22-0.50, P < .001).","[{'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Herrera', 'Affiliation': 'Department of Pediatrics, Wake Forrest University, Winston-Salem, North Carolina.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strong', 'Affiliation': 'Family Medicine and Public Health.'}, {'ForeName': 'Eastern', 'Initials': 'E', 'LastName': 'Kang-Sim', 'Affiliation': 'Departments of Pediatrics.'}, {'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Family Medicine and Public Health.'}, {'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Departments of Pediatrics.'}]",Pediatrics,['10.1542/peds.2021-055366']
2230,35712892,Impact of fentanyl use on initiation and discontinuation of methadone and buprenorphine/naloxone among people with prescription-type opioid use disorder: secondary analysis of a Canadian treatment trial.,"BACKGROUND AND AIMS


Fentanyl is primarily responsible for the current phase of the overdose epidemic in North America. Despite the benefits of treatment with medications for opioid use disorder (MOUD), there are limited data on the association between fentanyl, MOUD type and treatment engagement. The objectives of this analysis were to measure the impact of baseline fentanyl exposure on initiation and discontinuation of MOUD among individuals with prescription-type opioid use disorder (POUD).
DESIGN, SETTING AND PARTICIPANTS


Secondary analysis of a Canadian multi-site randomized pragmatic trial conducted between 2017 and 2020. Of the 269 randomized participants, 65.4% were male, 67.3% self-identified as white and 55.4% had a positive fentanyl urine drug test (UDT) at baseline. Fentanyl-exposed participants were more likely to be younger, to self-identify as non-white, to be unemployed or homeless and to be currently using stimulants than non-fentanyl-exposed participants.
INTERVENTIONS


Flexible take-home dosing buprenorphine/naloxone or supervised methadone models of care for 24 weeks.
MEASUREMENTS


Outcomes were (1) MOUD initiation and (2) time to (a) assigned and (b) overall MOUD discontinuation. Independent variables were baseline fentanyl UDT (predictor) and assigned MOUD (effect modifier).
FINDINGS


Overall, 209 participants (77.7%) initiated MOUD. In unadjusted analyses, fentanyl exposure was associated with reduced likelihood of treatment initiation [odds ratio (OR) = 0.18, 95% confidence interval (CI) = 0.08-0.36] and shorter median times in assigned [20 versus 168 days, hazard ratio (HR) = 3.61, 95% CI = 2.52-5.17] and any MOUD (27 versus 168 days, HR = 3.32, 95% CI = 2.30-4.80). The negative effects were no longer statistically significant in adjusted models, and no interaction between fentanyl and MOUD was observed for any of the outcomes (all P > 0.05).
CONCLUSIONS


Both buprenorphine/naloxone and methadone may be appropriate treatment options for people with prescription-type opioid use disorder regardless of fentanyl exposure. Other characteristics of fentanyl-exposed individuals appear to be driving the association with poorer treatment outcomes.",2022,"In unadjusted analyses, fentanyl exposure was associated with reduced likelihood of treatment initiation [odds ratio (OR) = 0.18, 95% confidence interval (CI) = 0.08-0.36] and shorter median times in assigned [20 versus 168 days, hazard ratio (HR) = 3.61, 95% CI = 2.52-5.17] and any MOUD (27 versus 168 days, HR = 3.32, 95% CI = 2.30-4.80).","['individuals with prescription-type opioid use disorder (POUD', 'people with prescription-type opioid use disorder regardless of fentanyl exposure', 'people with prescription-type opioid use disorder', '209 participants (77.7%) initiated MOUD', 'Secondary analysis of a Canadian multi-site randomized pragmatic trial conducted between 2017 and 2020', '269 randomized participants, 65.4% were male, 67.3% self-identified as white and 55.4% had a positive fentanyl urine drug test (UDT) at baseline', 'exposed participants were more likely to be younger, to self-identify as non-white, to be unemployed or homeless and to be currently using stimulants than non-fentanyl-exposed participants']","['Fentanyl', 'methadone', 'naloxone', 'buprenorphine/naloxone', 'fentanyl', 'methadone and buprenorphine/naloxone', 'buprenorphine']","['MOUD initiation and (2) time to (a) assigned and (b) overall MOUD discontinuation', 'MOUD']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1273860', 'cui_str': 'Prescription types'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C3658215', 'cui_str': 'Practical Clinical Trials'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",269.0,0.332825,"In unadjusted analyses, fentanyl exposure was associated with reduced likelihood of treatment initiation [odds ratio (OR) = 0.18, 95% confidence interval (CI) = 0.08-0.36] and shorter median times in assigned [20 versus 168 days, hazard ratio (HR) = 3.61, 95% CI = 2.52-5.17] and any MOUD (27 versus 168 days, HR = 3.32, 95% CI = 2.30-4.80).","[{'ForeName': 'M Eugenia', 'Initials': 'ME', 'LastName': 'Socias', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Medicine, Medical Sciences Building, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Jin Cheol', 'Initials': 'JC', 'LastName': 'Choi', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Wing Yin', 'Initials': 'WY', 'LastName': 'Mok', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruneau', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.""}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'T Cameron', 'Initials': 'TC', 'LastName': 'Wild', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Bozinoff', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Medicine, Medical Sciences Building, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Jutras-Aswad', 'Affiliation': ""Research Centre, Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Addiction (Abingdon, England)",['10.1111/add.15954']
2231,35712855,"A randomised controlled dismantling trial of sleep restriction therapies for chronic insomnia disorder in middle childhood: effects on sleep and anxiety, and possible contraindications.","Sleep restriction therapies likely drive improvement in insomnia in middle childhood via increases in homeostatic sleep pressure (e.g., evening sleepiness). Increased evening sleepiness may also dampen comorbid anxiety symptoms; and reduced wakefulness in bed may reduce worry. However, sleep restriction therapies have never been evaluated as a standalone intervention in this population. The mechanism of action needs testing, as do effects on anxiety, and cognitive performance and parasomnias (possible contraindications). This randomised controlled trial evaluated the efficacy of two ""doses"" of sleep restriction therapy (sleep restriction therapy, bedtime restriction therapy), compared to a control condition (time in bed regularisation). A total of 61 children (mean [SD, range] age 9.1 [2.1, 6-14] years; 54% female) with chronic insomnia disorder received two weekly 60-min treatment sessions with a psychologist. Sleep, sleepiness, anxiety, worry, cognitive performance, and parasomnias were measured pre-treatment, across treatment, and at 4-weeks post-treatment. Both the sleep and bedtime restriction groups experienced reductions in total sleep time (d = 1.38-2.27) and increases in evening sleepiness (d = 1.01-1.47) during the 2-week treatment, and improvements in insomnia (i.e., sleep onset latency; d = 1.10-1.21), relative to the control group. All groups reported improved anxiety and worry, yet there were no differences between the control and restriction groups (all p > 0.658). Time in bed increased at the 1-month follow-up, and benefits to sleep and insomnia were maintained. There were no adverse effects on cognitive functioning (all p > 0.259), nor parasomnia occurrence (all p > 0.740). These results suggest that sleep restriction therapies are brief, yet effective, standalone interventions for insomnia in middle childhood, and improvements are likely due to increased sleepiness, not sleep regularisation.",2022,"There were no adverse effects on cognitive functioning (all p > 0.259), nor parasomnia occurrence (all p > 0.740).","['61 children (mean [SD, range] age 9.1\xa0[2.1, 6-14]\xa0years; 54% female) with chronic insomnia disorder', 'chronic insomnia disorder in middle childhood']","['doses"" of sleep restriction therapy (sleep restriction therapy, bedtime restriction therapy', 'sleep restriction therapies']","['Sleep, sleepiness, anxiety, worry, cognitive performance, and parasomnias', 'cognitive functioning', 'insomnia (i.e., sleep onset latency', 'anxiety and worry', 'homeostatic sleep pressure', 'evening sleepiness', 'total sleep time', 'parasomnia occurrence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0030508', 'cui_str': 'Parasomnia'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",61.0,0.0166921,"There were no adverse effects on cognitive functioning (all p > 0.259), nor parasomnia occurrence (all p > 0.740).","[{'ForeName': 'Neralie', 'Initials': 'N', 'LastName': 'Cain', 'Affiliation': 'College of Education, Psychology, and Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Cele', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'College of Education, Psychology, and Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bartel', 'Affiliation': 'College of Education, Psychology, and Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Whittall', 'Affiliation': 'College of Education, Psychology, and Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Reeks', 'Affiliation': 'College of Education, Psychology, and Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gradisar', 'Affiliation': 'College of Education, Psychology, and Social Work, Flinders University, Adelaide, South Australia, Australia.'}]",Journal of sleep research,['10.1111/jsr.13658']
2232,35713110,Reduced anhedonia following internet-based cognitive-behavioral therapy for depression is mediated by enhanced reward circuit activation.,"BACKGROUND


Major depressive disorder (MDD) is a highly prevalent psychiatric condition, yet many patients do not receive adequate treatment. Novel and highly scalable interventions such as internet-based cognitive-behavioral-therapy (iCBT) may help to address this treatment gap. Anhedonia, a hallmark symptom of MDD that refers to diminished interest and ability to experience pleasure, has been associated with reduced reactivity in a neural reward circuit that includes medial prefrontal and striatal brain regions. Whether iCBT can reduce anhedonia severity in MDD patients, and whether these therapeutic effects are accompanied by enhanced reward circuit reactivity has yet to be examined.
METHODS


Fifty-two MDD patients were randomly assigned to either 10-week iCBT ( n  = 26) or monitored attention control (MAC,  n  = 26) programs. All patients completed pre- and post-treatment assessments of anhedonia (Snaith-Hamilton Pleasure Scale; SHAPS) and reward circuit reactivity [monetary incentive delay (MID) task during functional magnetic resonance imaging (fMRI)]. Healthy control participants ( n  = 42) also underwent two fMRI scans while completing the MID task 10 weeks apart.
RESULTS


Both iCBT and MAC groups exhibited a reduction in anhedonia severity post-treatment. Nevertheless, only the iCBT group exhibited enhanced nucleus accumbens (Nacc) and subgenual anterior cingulate cortex (sgACC) activation and functional connectivity from pre- to post-treatment in response to reward feedback. Enhanced Nacc and sgACC activations were associated with reduced anhedonia severity following iCBT treatment, with enhanced Nacc activation also mediating the reduction in anhedonia severity post-treatment.
CONCLUSIONS


These findings suggest that increased reward circuit reactivity may contribute to a reduction in anhedonia severity following iCBT treatment for depression.",2022,"Nevertheless, only the iCBT group exhibited enhanced nucleus accumbens (Nacc) and subgenual anterior cingulate cortex (sgACC) activation and functional connectivity from pre- to post-treatment in response to reward feedback.","['Fifty-two MDD patients', 'Healthy control participants ( n  = 42', 'MDD patients']","['Novel and highly scalable interventions such as internet-based cognitive-behavioral-therapy (iCBT', 'iCBT', 'monitored attention control (MAC,  n  = 26) programs', 'iCBT and MAC']","['anhedonia (Snaith-Hamilton Pleasure Scale; SHAPS) and reward circuit reactivity [monetary incentive delay (MID) task', 'Reduced anhedonia', 'Enhanced Nacc and sgACC activations', 'enhanced nucleus accumbens (Nacc) and subgenual anterior cingulate cortex (sgACC) activation and functional connectivity', 'anhedonia severity']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",52.0,0.0351943,"Nevertheless, only the iCBT group exhibited enhanced nucleus accumbens (Nacc) and subgenual anterior cingulate cortex (sgACC) activation and functional connectivity from pre- to post-treatment in response to reward feedback.","[{'ForeName': 'Shir', 'Initials': 'S', 'LastName': 'Hanuka', 'Affiliation': 'School of Psychological Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Olson', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Admon', 'Affiliation': 'School of Psychological Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Webb', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'William D S', 'Initials': 'WDS', 'LastName': 'Killgore', 'Affiliation': 'Department of Psychiatry, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Rauch', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Isabelle M', 'Initials': 'IM', 'LastName': 'Rosso', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, MA, USA.'}]",Psychological medicine,['10.1017/S0033291722001106']
2233,35713054,Development of a protocol for conducting a randomized control trial on effects of artificial intelligence on nutritional status of children post cardiac surgery.,"OBJECTIVE


To assess the effect of diet-related mobile application based on artificial intelligence on the nutritional status of children post-cardiac surgery, and to compare their diet-related problems with their counterparts having the usual diet.
METHODS


The two-arm double-blind randomised controlled trial will be conducted at a tertiary care hospital in Rawalpindi, Pakistan, over an expected duration of 6 months from March to August 2021. Intervention group A will be given a diet-related mobile application based on artificial intelligence, while usual-care group B will be handed a pamphlet with instructions related to post-operative diet on discharge.
RESULTS


The findings will improve perception about the influence of artificial intelligence on nutritional status of children post-cardiac surgery. If proven to be effective, this mobile application can be used in other hospitals.
CONCLUSIONS


The study protocol will give an indication that whether diet-related mobile application can contribute to improving the nutritional status of children post-cardiac surgery. As the pandemic has forced people to minimise hospital visits, this is the right time to evaluate the utility of such an application.
Randomised controlled trial


Study was registered on clinicaltrial.gov with trial identity number NCT04782635.",2022,"Intervention group A will be given a diet-related mobile application based on artificial intelligence, while usual-care group B will be handed a pamphlet with instructions related to post-operative diet on discharge.
","['children post-cardiac surgery', 'tertiary care hospital in Rawalpindi, Pakistan, over an expected duration of 6 months from March to August 2021', 'children post cardiac surgery']","['diet-related mobile application', 'diet-related mobile application based on artificial intelligence, while usual-care group B will be handed a pamphlet with instructions related to post-operative diet on discharge', 'diet-related mobile application based on artificial intelligence', 'artificial intelligence']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",[],,0.0932193,"Intervention group A will be given a diet-related mobile application based on artificial intelligence, while usual-care group B will be handed a pamphlet with instructions related to post-operative diet on discharge.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zahid', 'Affiliation': 'Al Shifa Trust Eye Hospital, School of Public Health, Rawalpindi, Pakistan.'}, {'ForeName': 'Ume', 'Initials': 'U', 'LastName': 'Sughra', 'Affiliation': 'Al Shifa Trust Eye Hospital, School of Public Health, Rawalpindi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.47391/JPMA.3751']
2234,35713035,Video based learning vs instructor led training for optimizing personal protective equipment use to prevent Covid-19 infection - a comparative study.,"Objectives


To evaluate two different types of education and training aids to improve compliance with guidelines related to personal protective equipment in healthcare workers.
METHODS


The quasi-experimental study was conducted at the Department of Gynaecology and Obstetrics, Combined Military Hospital, Rawalpindi, from July 1 to December 31, 2020, and comprised healthcare personnel who were divided into two equal groups. Group A received weekly instructor-led training session of donning and doffing for two hours. Group B was assigned to watch 30-min training videos weekly. After one month, an independent instructor evaluated both the groups using validated checklists, with maximum score 8 for donning and 14 for doffing. Data was analysed using SPSS 22.
RESULTS


Of the 60 subjects, 34(56.6%) were females and 26(43.3%) were males. There were 30(50%) subjects in group A with a mean age of 35.35±5.67years, and the remaining 30(50%) were n group B with a mean age of 33.12±4.13 years. There was no significant difference in donning and doffing scores between the groups (p>0.05).
CONCLUSIONS


Both types of education and training aids could be used to improve compliance with guidelines related to personal protective equipment in healthcare workers.",2022,"There was no significant difference in donning and doffing scores between the groups (p>0.05).
","['Of the 60 subjects, 34(56.6%) were females and 26(43.3%) were males', 'healthcare workers', 'Department of Gynaecology and Obstetrics, Combined Military Hospital, Rawalpindi, from July 1 to December 31, 2020, and comprised healthcare personnel who were divided into two equal groups', 'There were 30(50%) subjects in group A with a mean age of 35.35±5.67years, and the remaining 30(50%) were n group B with a mean age of 33.12±4.13 years']","['Video based learning vs instructor led training', 'weekly instructor-led training session of donning and doffing for two hours', 'education and training aids']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]",[],,0.0040493,"There was no significant difference in donning and doffing scores between the groups (p>0.05).
","[{'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Ansari', 'Affiliation': 'National University of Health Sciences, Rawalpindi, Pakistan.'}, {'ForeName': 'Uzma', 'Initials': 'U', 'LastName': 'Urooj', 'Affiliation': 'National University of Health Sciences, Rawalpindi, Pakistan.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Waseem', 'Affiliation': '4th Year MBBS Student,Shifa Medical College, Islamabad, Pakistan.'}, {'ForeName': 'Alveera', 'Initials': 'A', 'LastName': 'Ihtasham', 'Affiliation': 'City School, Capital Campus, Islamabad,Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.47391/JPMA.3359']
2235,35713012,"Effects of a grapeseed oil (Vitis vinifera L.) loaded dermocosmetic nanoemulgel on biophysical parameters of facial skin: A split-face, blinded, placebo-controlled study.","BACKGROUND


Worldwide, grapes (Vitis vinifera L.; family: Vitaceae) are one of the most important fruits. Grapeseed oil is rich in bioactive constituents that could be beneficial to the health and aesthetic features of human skin.
OBJECTIVE


This study was conducted to evaluate the effects of a novel grapeseed oil-loaded dermocosmetic nanoemulgel on biophysical parameters of facial skin.
METHODS


This was a split-face, blinded, placebo-controlled study. A novel grapeseed oil-loaded dermocosmetic nanoemulgel was developed and its effects on the biophysical parameters of the facial skin were evaluated and compared to those of a placebo formulation on the cheeks of 15 healthy volunteers. Melanin, erythema, sebum production, fine and large facial pores, moisture, and elasticity levels were measured using Mexameter®, Corneometer®, Sebumeter®, Cutometer®, and VisioFace®. Measurements were made on weekly basis for 12 weeks.
RESULTS


Compared to the placebo, the novel grapeseed oil-loaded dermocosmetic nanoemulgel received significantly higher sensory scores with regard to appearance, color, odor, consistency, adhesion, sensation, cohesiveness, and spreadability (p-value < 0.05). Additionally, the novel nanoemulgel continuously and significantly reduced skin melanin, erythema, sebum production, and fine and large pores (p-value < 0.05). On the other hand, the novel nanoemulgel continuously and significantly increased skin moisture contents and elasticity (p-value < 0.05).
CONCLUSION


The novel grapeseed oil-loaded dermocosmetic nanoemulgel had attractive cosmetic attributes that could be useful for improving imperfections of the human skin. Future studies are still needed to test and evaluate the benefits of this novel grapeseed oil-loaded dermocosmetic nanoemulgel in disease conditions.",2022,"Additionally, the novel nanoemulgel continuously and significantly reduced skin melanin, erythema, sebum production, and fine and large pores (p-value < 0.05).","['facial skin', '15 healthy volunteers']","['grapeseed oil (Vitis vinifera L.) loaded dermocosmetic nanoemulgel', 'placebo', 'novel grapeseed oil-loaded dermocosmetic nanoemulgel']","['skin melanin, erythema, sebum production, and fine and large pores', 'appearance, color, odor, consistency, adhesion, sensation, cohesiveness, and spreadability', 'skin moisture contents and elasticity', 'sensory scores', 'Melanin, erythema, sebum production, fine and large facial pores, moisture, and elasticity levels']","[{'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1446945', 'cui_str': 'Vitis vinifera'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",15.0,0.095892,"Additionally, the novel nanoemulgel continuously and significantly reduced skin melanin, erythema, sebum production, and fine and large pores (p-value < 0.05).","[{'ForeName': 'Ramzi', 'Initials': 'R', 'LastName': 'Shawahna', 'Affiliation': 'Department of Physiology, Pharmacology and Toxicology, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine.'}]",Journal of cosmetic dermatology,['10.1111/jocd.15161']
2236,35712968,Quality of life outcomes from the randomized trial of hyperthermic intraperitoneal chemotherapy following cytoreductive surgery for primary ovarian cancer (KOV-HIPEC-01).,"OBJECTIVE


To investigate the health-related quality of life (HRQOL) related to hyperthermic intraperitoneal chemotherapy (HIPEC) following primary or interval cytoreductive surgery for primary ovarian cancer.
METHODS


Between 2010 and 2016, a total of 184 patients were randomly assigned to receive cytoreductive surgery with HIPEC (n=92) or without HIPEC (n=92). Quality of life (QOL) assessment was evaluated at baseline (before surgery); on postoperative day 7; after the 3rd and 6th cycle of adjuvant chemotherapy; and at 3, 6, 9, and 12 months after randomization. Patient-reported QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC-QLQ-C30), ovarian cancer questionnaire modules (QLQ-OV28), and the MD Anderson Symptoms Inventory (MDASI).
RESULTS


Of the 184 patients enrolled, 165 (83/92 in the HIPEC group and 82/92 in the control group) participated in the baseline QOL assessment. There were no statistically significant differences in functional scales and symptom scales in QLQ-C30; symptom scales, including gastrointestinal symptoms QLQ-OV28; and severity and impact score in MDASI between the 2 treatment groups until 12 months after randomization.
CONCLUSION


HIPEC with cytoreductive surgery showed no statistically significant difference in HRQOL outcomes. Thus, implementation of HIPEC during either primary or interval cytoreductive surgery does not impair HRQOL.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01091636.",2022,"There were no statistically significant differences in functional scales and symptom scales in QLQ-C30; symptom scales, including gastrointestinal symptoms QLQ-OV28; and severity and impact score in MDASI between the 2 treatment groups until 12 months after randomization.
","['184 patients enrolled, 165', 'Between 2010 and 2016, a total of 184 patients', 'primary ovarian cancer (KOV-HIPEC-01']","['cytoreductive surgery with HIPEC (n=92) or without HIPEC', 'hyperthermic intraperitoneal chemotherapy (HIPEC) following primary or interval cytoreductive surgery', 'hyperthermic intraperitoneal chemotherapy']","['HRQOL outcomes', 'Quality of life (QOL) assessment', 'health-related quality of life (HRQOL', 'functional scales and symptom scales in QLQ-C30; symptom scales, including gastrointestinal symptoms QLQ-OV28; and severity and impact score in MDASI', 'Quality of life outcomes']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}]","[{'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",184.0,0.394978,"There were no statistically significant differences in functional scales and symptom scales in QLQ-C30; symptom scales, including gastrointestinal symptoms QLQ-OV28; and severity and impact score in MDASI between the 2 treatment groups until 12 months after randomization.
","[{'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Center for Gynecologic Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Dong-Eun', 'Initials': 'DE', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Team, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Pukyong National University, Busan, Korea.'}, {'ForeName': 'Hyeong In', 'Initials': 'HI', 'LastName': 'Ha', 'Affiliation': 'Department of Obstetrics and Gynecology, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Korea.'}, {'ForeName': 'Yoon Jung', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Department of Cancer Control & Population Health, National Cancer Center Graduate School of Cancer Science and Policy, Goyang, Korea.'}, {'ForeName': 'Suk-Joon', 'Initials': 'SJ', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Sang-Yoon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Center for Gynecologic Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Myong Cheol', 'Initials': 'MC', 'LastName': 'Lim', 'Affiliation': 'Center for Gynecologic Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.'}]",Journal of gynecologic oncology,['10.3802/jgo.2022.33.e54']
2237,35713447,Use of ginger to control nausea and vomiting caused by chemotherapy in patients with cervical cancer undergoing treatment: An experiment.,"INTRODUCTION


Uterine cervix tumors have an invasive nature, with the capacity to proliferate to surrounding organs such as the vagina, bladder, and rectum, as well as the capacity for dissemination and involvement of structures distant from its place of origin. According to the International Federation of Gynecology and Obstetrics, patients with stages IB I, IB I microscopic (small dimension <4 cm) are indicated for radiotherapy or adjuvant chemoradiotherapy with cisplatin (40 mg/m2). However, cisplatin has side effects such as hematological implications (anemia, neutropenia, and thrombocytopenia), gastrointestinal disorders (nausea, vomiting, diarrhea, constipation), and fatigue. Zingiber officinale contains bioactive compounds that act on pregnancy and postoperative nausea, chemotherapy-induced nausea and vomiting, and also in the management of fatigue, myalgia, and insomnia. This study aimed to evaluate the effects of ginger on chemotherapy-induced nausea and vomiting in patients with cervical cancer undergoing treatment with cisplatin and radiotherapy.
METHODS AND ANALYSES


A randomized intervention clinical and controlled trial with a triple-blind design is described, comparing the effects of institutional antiemetic therapy alone, as well as in combination with 2 different ginger concentrations.
ETHICS AND DISSEMINATION


Due to the nature of the study, we obtained approval from the Division Ethics Committee of Liga Contra o Câncer. All participants signed an informed consent form prior to randomization. The results of this study will be published in peer-reviewed journals. The data collected will also be available in a public repository of data.
TRIAL REGISTRATION NUMBER


This study is registered in the Brazilian Registry of Clinical Trials under number RBR-47yx6p9. This study was approved by the Division Ethics Committee of Liga Contra o Câncer under CAAE 40602320.0.0000.5293.",2022,"Zingiber officinale contains bioactive compounds that act on pregnancy and postoperative nausea, chemotherapy-induced nausea and vomiting, and also in the management of fatigue, myalgia, and insomnia.","['patients with cervical cancer undergoing treatment', 'patients with stages', 'patients with cervical cancer undergoing treatment with']","['radiotherapy or adjuvant chemoradiotherapy with cisplatin', 'chemotherapy', 'cisplatin and radiotherapy', 'IB', 'cisplatin']","['pregnancy and postoperative nausea, chemotherapy-induced nausea and vomiting', 'nausea and vomiting', 'hematological implications (anemia, neutropenia, and thrombocytopenia), gastrointestinal disorders (nausea, vomiting, diarrhea, constipation), and fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Chemoradiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.110927,"Zingiber officinale contains bioactive compounds that act on pregnancy and postoperative nausea, chemotherapy-induced nausea and vomiting, and also in the management of fatigue, myalgia, and insomnia.","[{'ForeName': 'Romeika Lorena Mendes', 'Initials': 'RLM', 'LastName': 'da Silva', 'Affiliation': 'Research and Innovation Teaching Institute, Liga Contra o Cancer. Natal, RN, Brazil.'}, {'ForeName': 'Tâmara Taynah Medeiros', 'Initials': 'TTM', 'LastName': 'da Silva', 'Affiliation': 'Nursing Graduate Program, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Renata Lima', 'Initials': 'RL', 'LastName': 'Pessoa', 'Affiliation': 'Health Sciences Postgraduate Program, Federal University of Rio Grande do Norte (UFRN), Natal, RN, Brazil.'}, {'ForeName': 'Ayane Cristine Alves', 'Initials': 'ACA', 'LastName': 'Sarmento', 'Affiliation': 'Health Sciences Postgraduate Program, Federal University of Rio Grande do Norte (UFRN), Natal, RN, Brazil.'}, {'ForeName': 'Kleyton Santos', 'Initials': 'KS', 'LastName': 'Medeiros', 'Affiliation': 'Research and Innovation Teaching Institute, Liga Contra o Cancer. Natal, RN, Brazil.'}, {'ForeName': 'Daniele Vieira', 'Initials': 'DV', 'LastName': 'Dantas', 'Affiliation': 'Nursing Graduate Program, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Rodrigo Assis Neves', 'Initials': 'RAN', 'LastName': 'Dantas', 'Affiliation': 'Nursing Graduate Program, Federal University of Rio Grande do Norte, Natal, Brazil.'}]",Medicine,['10.1097/MD.0000000000029403']
2238,35713444,The effect of binaural beat audio on anxiety in patients undergoing fiberoptic bronchoscopy: A prospective randomized controlled trial.,"BACKGROUND


Fiberoptic bronchoscopy is an invasive procedure known to induce anxiety in patients. Binaural beat therapy, in which sounds of different frequencies are delivered to the 2 ears to entrain the brainwaves, has been used to reduce anxiety in some operations. This study aimed to determine the anxiolytic effects of binaural beat audio in patients undergoing fiberoptic bronchoscopy.
METHODS


Eligible subjects were randomly assigned to receive binaural beat music, plain music, or no music. They were asked to wear earphones starting approximately 15 minutes before the bronchoscopy. The level of anxiety was measured using the State-Trait Anxiety Inventory questionnaire. Blood pressure, heart rate, and sedative drug administration were also recorded.
RESULTS


One hundred and twelve subjects were randomized into binaural beat music (n = 38), plain music (n = 38), and no music (n = 36) groups. The mean change in post-bronchoscopy State-Trait Anxiety Inventory state score in the binaural beat music, plain music, and no music group was -7.26 (P < .001), -3.92 (P = .005), and -1.12 (P = .454), respectively. The mean systolic blood pressure and diastolic blood pressure significantly decreased from baseline by -9.89 (P = .002) and -5.76 (P = .005), respectively, in the binaural group. The mean heart rate increased from baseline by 3.32 (P = .035), 5.21 (P = .038), and 3.64 (P = .149) in the binaural beat music, plain music, and no music groups, respectively.
CONCLUSION


Binaural beat music appeared to reduce anxiety among patients undergoing fiberoptic bronchoscopy.Trial registration: TCTR, TCTR20200915002. Registered 14 September 2020 - Retrospectively registered.",2022,"The mean heart rate increased from baseline by 3.32 (P = .035), 5.21","['patients undergoing fiberoptic bronchoscopy', 'One hundred and twelve subjects', 'patients', 'Registered 14 September 2020 - Retrospectively registered', 'Eligible subjects']","['binaural beat music', 'binaural beat audio', 'Fiberoptic bronchoscopy', 'plain music', 'binaural beat music, plain music, or no music']","['level of anxiety', 'anxiolytic effects', 'mean heart rate', 'mean systolic blood pressure and diastolic blood pressure', 'Blood pressure, heart rate, and sedative drug administration', 'mean change in post-bronchoscopy State-Trait Anxiety Inventory state score', 'State-Trait Anxiety Inventory questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189391', 'cui_str': 'Fiberoptic bronchoscopy'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0189391', 'cui_str': 'Fiberoptic bronchoscopy'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",112.0,0.085342,"The mean heart rate increased from baseline by 3.32 (P = .035), 5.21","[{'ForeName': 'Pornchai', 'Initials': 'P', 'LastName': 'Opartpunyasarn', 'Affiliation': 'Pulmonary and Critical Care Division, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Pornpattana', 'Initials': 'P', 'LastName': 'Vichitvejpaisal', 'Affiliation': 'Department of Ophthalmology, Chulabhorn Hospital, Bangkok, Thailand.'}, {'ForeName': 'Nittha', 'Initials': 'N', 'LastName': 'Oer-Areemitr', 'Affiliation': 'Pulmonary and Critical Care Division, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}]",Medicine,['10.1097/MD.0000000000029392']
2239,35713352,Empathic communication in dignity therapy: Feasibility of measurement and descriptive findings.,"OBJECTIVE


Dignity therapy (DT) is a guided process conducted by a health professional for reviewing one's life to promote dignity through the illness process. Empathic communication has been shown to be important in clinical interactions but has yet to be examined in the DT interview session. The Empathic Communication Coding System (ECCS) is a validated, reliable coding system used in clinical interactions. The aims of this study were (1) to assess the feasibility of the ECCS in DT sessions and (2) to describe the process of empathic communication during DT sessions.
METHODS


We conducted a secondary analysis of 25 transcripts of DT sessions with older cancer patients. These DT sessions were collected as part of larger randomized controlled trial. We revised the ECCS and then coded the transcripts using the new ECCS-DT. Two coders achieved inter-rater reliability ( κ  = 0.84) on 20% of the transcripts and then independently coded the remaining transcripts.
RESULTS


Participants were individuals with cancer between the ages of 55 and 75. We developed the ECCS-DT with four empathic response categories: acknowledgment, reflection, validation, and shared experience. We found that of the 235 idea units, 198 had at least one of the four empathic responses present. Of the total 25 DT sessions, 17 had at least one empathic response present in all idea units.
SIGNIFICANCE OF RESULTS


This feasibility study is an essential first step in our larger program of research to understand how empathic communication may play a role in DT outcomes. We aim to replicate findings in a larger sample and also investigate the linkage empathic communication may have in the DT session to positive patient outcomes. These findings, in turn, may lead to further refinement of training for dignity therapists, development of research into empathy as a mediator of outcomes, and generation of new interventions.",2022,"We developed the ECCS-DT with four empathic response categories: acknowledgment, reflection, validation, and shared experience.","['25 transcripts of DT sessions with older cancer patients', 'Participants were individuals with cancer between the ages of 55 and 75']","['Empathic Communication Coding System (ECCS', 'ECCS', 'Dignity therapy (DT']",['inter-rater reliability'],"[{'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0435804,"We developed the ECCS-DT with four empathic response categories: acknowledgment, reflection, validation, and shared experience.","[{'ForeName': 'Carma L', 'Initials': 'CL', 'LastName': 'Bylund', 'Affiliation': 'Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, FL.'}, {'ForeName': 'Greenberry', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': 'Department of Communication, Flagler College, St. Augustine, FL.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Mroz', 'Affiliation': 'Department of Internal Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'Biobehavioral Nursing Science, University of Florida, Gainesville, FL.'}, {'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Biobehavioral Nursing Science, University of Florida, Gainesville, FL.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Emanuel', 'Affiliation': 'The Mongan Institute, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fitchett', 'Affiliation': 'Department of Religion, Health and Human Values, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Handzo', 'Affiliation': 'Health Services Research and Quality, Healthcare Chaplaincy Network, New York, NY.'}, {'ForeName': 'Harvey Max', 'Initials': 'HM', 'LastName': 'Chochinov', 'Affiliation': 'Department of Psychiatry, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bluck', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, FL.'}]",Palliative & supportive care,['10.1017/S1478951521001188']
2240,35713342,Placebo Response in Trials of Negative Symptoms in Schizophrenia: A Critical Reassessment of the Evidence.,"BACKGROUND


Summarizing evidence from clinical trials of patients with schizophrenia with predominant or prominent negative symptoms (NS), a prior meta-analysis reported a large placebo effect in negative symptoms (Cohen's d = 2.909). Assuming that such an effect was clinically not plausible, we performed a critical re-assessment and an update of the previous results with newly available data from add-on and monotherapy studies.
STUDY DESIGN


Random-effect meta/regression analysis of trials that focused on predominant or prominent NS; and adopted a double-blind, randomized, placebo-controlled design. The final pooled meta-analytic database, based on the available add-on and monotherapy studies combined, included 24 publications containing data on a total of 25 studies (21 add-on, 4 monotherapy).
STUDY RESULTS


The pooled overall estimate for the placebo effect from the primary analysis for all included studies had a medium effect size, with a Cohen's d value of 0.6444 (SE = 0.091). The estimates were similar in the add-on and monotherapy studies. Meta-regression indicated that the high placebo response was significantly associated with clinical trial characteristics, including the high ratio of patients assigned to active vs. placebo treatment and short trial duration.
CONCLUSIONS


These results represent a major downward correction for a current effect size estimate of the placebo response in the negative symptoms of schizophrenia. Our findings also pinpoint certain clinical trial characteristics, which may serve as important predictors of the placebo response. The knowledge of these factors can have important implications for drug development and trial design for new drugs for negative symptoms of schizophrenia.",2022,The knowledge of these factors can have important implications for drug development and trial design for new drugs for negative symptoms of schizophrenia.,"['Schizophrenia', 'patients with schizophrenia with predominant or prominent negative symptoms (NS', '24 publications containing data on a total of 25 studies (21 add-on, 4 monotherapy']","['placebo', 'Placebo']",[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.383945,The knowledge of these factors can have important implications for drug development and trial design for new drugs for negative symptoms of schizophrenia.,"[{'ForeName': 'Pál', 'Initials': 'P', 'LastName': 'Czobor', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Brigitta', 'Initials': 'B', 'LastName': 'Kakuszi', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary.'}]",Schizophrenia bulletin,['10.1093/schbul/sbac061']
2241,35713310,Evaluating the beads of life groups: hearing from our participants.,"INTRODUCTION AND AIMS


The Beads of Life (BOL) approach uses a narratively informed methodology 'to enable children and young people to make sense of their cancer journey in ways that make them stronger'. We will share feedback from BOL groups and reflect on changes made over time.
METHOD


Between 2014 and 2019, we have run 14 groups. Participants were aged 13-25, had received a diagnosis of cancer and were either on or had completed treatment. Quantitative and qualitative feedback was gathered at each workshop and 1 month later, with qualitative data then being analysed using thematic analysis.
RESULTS


106 young people attended the groups. Young people reported that sharing experiences of cancer was useful, that they enjoyed the group and that they were highly likely to recommend it to others. Feedback remained consistent a month post-intervention. Qualitative feedback showed the value young people placed on meeting others, sharing their stories and on things they learnt about themselves from the group.
DISCUSSION


Themes support the intention of the intervention to provide a safe space for young people to share and reflect on their cancer journey, to connect with others and to enable peer support and mutual learning.",2022,"Qualitative feedback showed the value young people placed on meeting others, sharing their stories and on things they learnt about themselves from the group.
","['106 young people attended the groups', 'Participants were aged 13-25, had received a diagnosis of cancer and were either on or had completed treatment', 'Between 2014 and 2019', 'Young people']",[],['Quantitative and qualitative feedback'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",106.0,0.0643025,"Qualitative feedback showed the value young people placed on meeting others, sharing their stories and on things they learnt about themselves from the group.
","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Valentino', 'Affiliation': '8964University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Xeni', 'Initials': 'X', 'LastName': 'Daniilidi', 'Affiliation': '8964University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Portnoy', 'Affiliation': '8964University College London Hospitals NHS Foundation Trust, London, UK.'}]",Clinical child psychology and psychiatry,['10.1177/13591045221090782']
2242,35713300,SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19.,"BACKGROUND


Monoclonal antibodies (mAbs) are laboratory-produced molecules derived from the B cells of an infected host. They are being investigated as potential prophylaxis to prevent coronavirus disease 2019 (COVID-19).
OBJECTIVES


To assess the effects of SARS-CoV-2-neutralising mAbs, including mAb fragments, to prevent infection with SARS-CoV-2 causing COVID-19; and to maintain the currency of the evidence, using a living systematic review approach.
SEARCH METHODS


We searched the Cochrane COVID-19 Study Register, MEDLINE, Embase, and three other databases on 27 April 2022. We checked references, searched citations, and contacted study authors to identify additional studies.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) that evaluated SARS-CoV-2-neutralising mAbs, including mAb fragments, alone or combined, versus an active comparator, placebo, or no intervention, for pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) of COVID-19. We excluded studies of SARS-CoV-2-neutralising mAbs to treat COVID-19, as these are part of another review.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed search results, extracted data, and assessed risk of bias using Cochrane RoB 2. Prioritised outcomes were infection with SARS-CoV-2, development of clinical COVID-19 symptoms, all-cause mortality, admission to hospital, quality of life, adverse events (AEs), and serious adverse events (SAEs). We rated the certainty of evidence using GRADE.
MAIN RESULTS


We included four RCTs of 9749 participants who were previously uninfected and unvaccinated at baseline. Median age was 42 to 76 years. Around 20% to 77.5% of participants in the PrEP studies and 35% to 100% in the PEP studies had at least one risk factor for severe COVID-19. At baseline, 72.8% to 82.2% were SARS-CoV-2 antibody seronegative. We identified four ongoing studies, and two studies awaiting classification. Pre-exposure prophylaxis Tixagevimab/cilgavimab versus placebo One study evaluated tixagevimab/cilgavimab versus placebo in participants exposed to SARS-CoV-2 wild-type, Alpha, Beta, and Delta variant. About 39.3% of participants were censored for efficacy due to unblinding and 13.8% due to vaccination. Within six months, tixagevimab/cilgavimab probably decreases infection with SARS-CoV-2 (risk ratio (RR) 0.45, 95% confidence interval (CI) 0.29 to 0.70; 4685 participants; moderate-certainty evidence), decreases development of clinical COVID-19 symptoms (RR 0.18, 95% CI 0.09 to 0.35; 5172 participants; high-certainty evidence), and may decrease admission to hospital (RR 0.03, 95% CI 0 to 0.59; 5197 participants; low-certainty evidence). Tixagevimab/cilgavimab may result in little to no difference on mortality within six months, all-grade AEs, and SAEs (low-certainty evidence). Quality of life was not reported. Casirivimab/imdevimab versus placebo One study evaluated casirivimab/imdevimab versus placebo in participants who may have been exposed to SARS-CoV-2 wild-type, Alpha, and Delta variant. About 36.5% of participants opted for SARS-CoV-2 vaccination and had a mean of 66.1 days between last dose of intervention and vaccination. Within six months, casirivimab/imdevimab may decrease infection with SARS-CoV-2 (RR 0.01, 95% CI 0 to 0.14; 825 seronegative participants; low-certainty evidence) and may decrease development of clinical COVID-19 symptoms (RR 0.02, 95% CI 0 to 0.27; 969 participants; low-certainty evidence). We are uncertain whether casirivimab/imdevimab affects mortality regardless of the SARS-CoV-2 antibody serostatus. Casirivimab/imdevimab may increase all-grade AEs slightly (RR 1.14, 95% CI 0.98 to 1.31; 969 participants; low-certainty evidence). The evidence is very uncertain about the effects on grade 3 to 4 AEs and SAEs within six months. Admission to hospital and quality of life were not reported. Postexposure prophylaxis Bamlanivimab versus placebo One study evaluated bamlanivimab versus placebo in participants who may have been exposed to SARS-CoV-2 wild-type. Bamlanivimab probably decreases infection with SARS-CoV-2 versus placebo by day 29 (RR 0.76, 95% CI 0.59 to 0.98; 966 participants; moderate-certainty evidence), may result in little to no difference on all-cause mortality by day 60 (R 0.83, 95% CI 0.25 to 2.70; 966 participants; low-certainty evidence), may increase all-grade AEs by week eight (RR 1.12, 95% CI 0.86 to 1.46; 966 participants; low-certainty evidence), and may increase slightly SAEs (RR 1.46, 95% CI 0.73 to 2.91; 966 participants; low-certainty evidence). Development of clinical COVID-19 symptoms, admission to hospital within 30 days, and quality of life were not reported. Casirivimab/imdevimab versus placebo One study evaluated casirivimab/imdevimab versus placebo in participants who may have been exposed to SARS-CoV-2 wild-type, Alpha, and potentially, but less likely to Delta variant. Within 30 days, casirivimab/imdevimab decreases infection with SARS-CoV-2 (RR 0.34, 95% CI 0.23 to 0.48; 1505 participants; high-certainty evidence), development of clinical COVID-19 symptoms (broad-term definition) (RR 0.19, 95% CI 0.10 to 0.35; 1505 participants; high-certainty evidence), may result in little to no difference on mortality (RR 3.00, 95% CI 0.12 to 73.43; 1505 participants; low-certainty evidence), and may result in little to no difference in admission to hospital. Casirivimab/imdevimab may slightly decrease grade 3 to 4 AEs (RR 0.50, 95% CI 0.24 to 1.02; 2617 participants; low-certainty evidence), decreases all-grade AEs (RR 0.70, 95% CI 0.61 to 0.80; 2617 participants; high-certainty evidence), and may result in little to no difference on SAEs in participants regardless of SARS-CoV-2 antibody serostatus. Quality of life was not reported.
AUTHORS' CONCLUSIONS


For PrEP, there is a decrease in development of clinical COVID-19 symptoms (high certainty), infection with SARS-CoV-2 (moderate certainty), and admission to hospital (low certainty) with tixagevimab/cilgavimab. There is low certainty of a decrease in infection with SARS-CoV-2, and development of clinical COVID-19 symptoms; and a higher rate for all-grade AEs with casirivimab/imdevimab. For PEP, there is moderate certainty of a decrease in infection with SARS-CoV-2 and low certainty for a higher rate for all-grade AEs with bamlanivimab. There is high certainty of a decrease in infection with SARS-CoV-2, development of clinical COVID-19 symptoms, and a higher rate for all-grade AEs with casirivimab/imdevimab.   Although there is high-to-moderate certainty evidence for some outcomes, it is insufficient to draw meaningful conclusions. These findings only apply to people unvaccinated against COVID-19. They are only applicable to the variants prevailing during the study and not other variants (e.g. Omicron). In vitro, tixagevimab/cilgavimab is effective against Omicron, but there are no clinical data. Bamlanivimab and casirivimab/imdevimab are ineffective against Omicron in vitro. Further studies are needed and publication of four ongoing studies may resolve the uncertainties.",2022,"Development of clinical COVID-19 symptoms, admission to hospital within 30 days, and quality of life were not reported.","['9749\xa0participants who were previously uninfected and unvaccinated at baseline', 'Embase, and three other databases on 27 April 2022', 'Median age was 42 to 76 years', 'participants exposed to SARS-CoV-2 wild-type, Alpha, Beta, and Delta variant', 'participants who may have been exposed to SARS-CoV-2 wild-type', 'participants who may have been exposed to SARS-CoV-2 wild-type, Alpha, and Delta variant']","['Tixagevimab/cilgavimab', 'bamlanivimab versus placebo', 'tixagevimab/cilgavimab versus placebo', 'Bamlanivimab and casirivimab/imdevimab', 'Casirivimab/imdevimab versus placebo', 'SARS-CoV-2-neutralising mAbs, including mAb fragments, alone or combined, versus an active comparator, placebo, or no intervention, for pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) of COVID-19', 'For PrEP', 'prophylaxis Tixagevimab/cilgavimab versus placebo', 'placebo']","['Admission to hospital and quality of life', 'clinical COVID-19 symptoms', 'clinical COVID-19 symptoms, admission to hospital within 30 days, and quality of life', 'infection with SARS-CoV-2', 'Quality of life', 'infection with\xa0SARS-CoV-2, development of clinical COVID-19 symptoms, all-cause mortality, admission to hospital, quality of life, adverse events (AEs), and serious adverse events (SAEs', 'mortality']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0205419', 'cui_str': 'Variant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",825.0,0.45508,"Development of clinical COVID-19 symptoms, admission to hospital within 30 days, and quality of life were not reported.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hirsch', 'Affiliation': 'Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Yun Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Piechotta', 'Affiliation': 'Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Khai Li', 'Initials': 'KL', 'LastName': 'Chai', 'Affiliation': 'Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Lise J', 'Initials': 'LJ', 'LastName': 'Estcourt', 'Affiliation': 'Haematology/Transfusion Medicine, NHS Blood and Transplant, Oxford, UK.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Monsef', 'Affiliation': 'Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Salomon', 'Affiliation': 'Laboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': 'Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'So-Osman', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'McQuilten', 'Affiliation': 'Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': 'School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jakob J', 'Initials': 'JJ', 'LastName': 'Malin', 'Affiliation': 'Department I for Internal Medicine, Division of Infectious Diseases, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Stegemann', 'Affiliation': 'Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Skoetz', 'Affiliation': 'Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kreuzberger', 'Affiliation': 'Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD014945.pub2']
2243,35713267,Soft and hard tissue changes after immediate implant placement with or without a sub-epithelial connective tissue graft: results from a 6-months pilot randomized controlled clinical trial.,"AIM


The present pilot RCT aimed to investigate the influence of a connective tissue graft (CTG) in combination with the immediate implant placement (IIP) on hard and soft tissues healing, without a bone replacement graft in the gap between the implant and the socket walls.
MATERIAL AND METHODS


Thirty patients requiring extraction of one anterior tooth (from premolar to premolar) were randomly assigned to one of the two treatment groups (test: IIP+CTG; control: IIP). Cone-beam computed tomography (CBCT) and optically scans were performed before tooth extraction and at 6-months follow-up. Then, DICOM files were superimposed in order to allow the evaluation of osseous ridge and buccal bone changes, while the superimposition of DICOM and STL (Standard Tessellation Language) files allowed for evaluating of soft tissue contour. For testing the differences between the two groups, the non-parametric test as Wilcoxon rank-sum test, was used.
RESULTS


Twenty-six out of the thirty enrolled patients, attended the 6-month follow-up visit. The 4 patients of control group that were lost to follow-up, were analyzed under the intention-to-treat principle. No statistically significant differences between the groups were observed for the vertical buccal bone resorption (p=0.90), as well as for the horizontal buccal bone resorption at all measured levels. Significant differences were found between test and control groups in the horizontal dimensional changes of osseous ridge at the most coronal aspect (p=0.0003 and p=0.02). Changes of tissue contour ranged between -0.32 and -0.04 mm in the test group, and between -1.94 and -1.08 mm in the control group, while changes of soft tissue thickness varied between 1.33 and 2.42 mm in the test group, and between -0.16 and 0.88 mm in the control group, with statistically significant differences for both variables at all measured levels. At 6 months, the mean volume increase was 6.76±8.94 mm 3  and 0.16±0.42 mm 3  in the test and control groups, respectively, with statistically significant difference.
CONCLUSIONS


The findings of the present study indicate that the adjunct of a connective tissue graft at the time of immediate implant placement, without bone grafting, does not influence vertical bone resorption. Within the limits of the present study, it can be suggested that the adjunct of a connective tissue graft at the time of immediate implant placement, without bone grafting, reduces the horizontal changes of the alveolar ridge. Moreover, it allows maintenance of the tissue contour due to an increase in soft tissue thickness.",2022,Significant differences were found between test and control groups in the horizontal dimensional changes of osseous ridge at the most coronal aspect (p=0.0003 and p=0.02).,"['Thirty patients requiring extraction of one anterior tooth (from premolar to premolar', 'Twenty-six out of the thirty enrolled patients, attended the 6-month follow-up visit']","['immediate implant placement with or without a sub-epithelial connective tissue graft', 'immediate implant placement (IIP', 'Cone-beam computed tomography (CBCT', 'connective tissue graft (CTG']","['Soft and hard tissue changes', 'soft tissue thickness', 'vertical bone resorption', 'horizontal dimensional changes of osseous ridge', 'horizontal buccal bone resorption', 'mean volume increase', 'Changes of tissue contour', 'vertical buccal bone resorption']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",30.0,0.0255103,Significant differences were found between test and control groups in the horizontal dimensional changes of osseous ridge at the most coronal aspect (p=0.0003 and p=0.02).,"[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Guglielmi', 'Affiliation': 'Department of Periodontology, Università Vita-Salute San Raffaele, Milano, Italy.'}, {'ForeName': 'Giovanna Laura', 'Initials': 'GL', 'LastName': 'Di Domenico', 'Affiliation': 'Department of Periodontology, Università Vita-Salute San Raffaele, Milano, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Aroca', 'Affiliation': '26K Center for Clinical Research, Paris, France; Department of Periodontology, Bern University, Bern, Switzerland.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Vignoletti', 'Affiliation': 'Thinking Perio Research, Verona, Italy; Department of Periodontology, Faculty of Odontology, Complutense University, Madrid, Spain.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Ciaravino', 'Affiliation': 'Department of Periodontology, Università Vita-Salute San Raffaele, Milano, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Donghia', 'Affiliation': 'National Institute of Gastroenterology ""S. De Bellis"" Research Hospital, Castellana Grotte, Italy.'}, {'ForeName': 'Massimo de', 'Initials': 'M', 'LastName': 'Sanctis', 'Affiliation': 'Department of Periodontology, Università Vita-Salute San Raffaele, Milano, Italy.'}]",Journal of clinical periodontology,['10.1111/jcpe.13685']
2244,35713247,Early Postoperative Polydeoxyribonucleotide Injections Prevent Hypertrophic Scarring after Thyroidectomy: A Randomized Controlled Trial.,"OBJECTIVE


Polydeoxyribonucleotide (PDRN) is known to enhance wound healing, but there has been no clinical trial investigating the effect of PDRN on scar prevention in surgical wounds. This study aimed to evaluate the efficacy of PDRN administration in preventing postoperative scars.
APPROACH


In this randomized controlled trial (NCT05149118), 44 patients who underwent open thyroidectomy were randomly assigned to the PDRN treatment or untreated control group. Only patients in the treatment group received two consecutive injections of PDRN one and two days after surgery. The modified Vancouver Scar Scale (mVSS), patients' subjective symptoms, erythema index (EI), melanin index (MI), and scar height were assessed three months after surgery.
RESULTS


Patients in the treatment group had lower mVSS scores (1.619 ± 1.244 vs. 2.500 ± 1.540, respectively; P = 0.059) and a significantly lower vascularity subscore (0.476 ± 0.512 vs. 0.900 ± 0.447, respectively; P = 0.010) than those in the control group at the 3-month follow-up. Compared with the control group, the level of subjective symptoms, EI, and scar height were all significantly lowered in the PDRN injection group. No specific side effects related to PDRN injection were observed.
INNOVATION


This is the first clinical study which demonstrated that PDRN injections rapidly decreased postsurgical wound erythema and as a result, significantly reduced both excessive scar formation and accompanying symptoms.
CONCLUSION


Early postoperative injection of PDRN is an effective and safe treatment to prevent hypertrophic scars and improve scar outcomes.",2022,"RESULTS


Patients in the treatment group had lower mVSS scores (1.619 ± 1.244 vs. 2.500 ± 1.540, respectively; P = 0.059) and a significantly lower vascularity subscore (0.476 ± 0.512 vs. 0.900 ± 0.447, respectively; P = 0.010) than those in the control group at the 3-month follow-up.","['Hypertrophic Scarring after Thyroidectomy', '44 patients who underwent open thyroidectomy']","['PDRN', 'Polydeoxyribonucleotide Injections', 'PDRN injections', 'PDRN treatment or untreated control group', 'Polydeoxyribonucleotide (PDRN']","['postsurgical wound erythema', ""modified Vancouver Scar Scale (mVSS), patients' subjective symptoms, erythema index (EI), melanin index (MI), and scar height"", 'vascularity subscore', 'level of subjective symptoms, EI, and scar height', 'lower mVSS scores']","[{'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0032468', 'cui_str': 'Polydeoxyribonucleotides'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0406833', 'cui_str': 'Wound erythema'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",44.0,0.0536084,"RESULTS


Patients in the treatment group had lower mVSS scores (1.619 ± 1.244 vs. 2.500 ± 1.540, respectively; P = 0.059) and a significantly lower vascularity subscore (0.476 ± 0.512 vs. 0.900 ± 0.447, respectively; P = 0.010) than those in the control group at the 3-month follow-up.","[{'ForeName': 'Bo Ri', 'Initials': 'BR', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Bundang Hospital, 65462, Department of Dermatology, 82 Gumi-Ro 173 Beon-Gil, Seongnam, Korea (the Republic of), 13620; kbori87@naver.com.'}, {'ForeName': 'Soon Hyo', 'Initials': 'SH', 'LastName': 'Kwon', 'Affiliation': 'Seoul National University Bundang Hospital, 65462, Department of Dermatology, Seongnam, Korea (the Republic of); soonhyo17@hanmail.net.'}, {'ForeName': 'Jee Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Bundang Hospital, 65462, Seongnam, Korea (the Republic of); zapdos2@naver.com.'}, {'ForeName': 'Woo-Jin', 'Initials': 'WJ', 'LastName': 'Jeong', 'Affiliation': 'Seoul National University Bundang Hospital, 65462, Seongnam, Korea (the Republic of); safar@snubh.org.'}, {'ForeName': 'Wonjae', 'Initials': 'W', 'LastName': 'Cha', 'Affiliation': 'Seoul National University Bundang Hospital, 65462, Seongnam, Korea (the Republic of); chawonjae@snubh.org.'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Jung', 'Affiliation': 'Seoul National University Bundang Hospital, 65462, Seongnam, Korea (the Republic of); entist@naver.com.'}, {'ForeName': 'Jung Im', 'Initials': 'JI', 'LastName': 'Na', 'Affiliation': 'Seoul National University Bundang Hospital, 65462, Seongnam, Korea (the Republic of); vividna@gmail.com.'}, {'ForeName': 'Chang Hun', 'Initials': 'CH', 'LastName': 'Huh', 'Affiliation': 'Seoul National University Bundang Hospital, 65462, Seongnam, Korea (the Republic of); chhuh@snu.ac.kr.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Shin', 'Affiliation': 'Seoul National University Bundang Hospital, 65462, Seongnam, Korea (the Republic of); spellbound00@hanmail.net.'}]",Advances in wound care,['10.1089/wound.2022.0025']
2245,35713224,Effects of Artificial Intelligence (AI)-Assisted Dental Monitoring Intervention in Patients with Periodontitis: A Randomized Controlled Trial.,"AIM


To evaluate the effects of an at-home AI-assisted dental monitoring application on treatment outcomes in patients with periodontitis.
MATERIALS AND METHODS


Participants with periodontitis were recruited and randomly assigned into an AI (AI; n = 16), AI and human counseling (AIHC; n = 17), or control (CG; n = 20) group. All participants received nonsurgical periodontal treatment. We employed an AI-assisted tool called DENTAL MONITORING® (DM) intervention, a new technological AI monitoring product that utilizes smartphone cameras for intraoral scanning and assessment. Patients in the AI and AIHC groups respectively received additional (a) DM or (b) DM with real-person counseling over three months. Periodontal parameters were collected at baseline and follow-ups. A mixed-design model analyzed the follow-up effects over time.
RESULTS


The AI and AIHC groups respectively exhibited greater improvement in probing pocket depth [Mean diff = -0.9±0.4 and -1.4±0.3, effect size (ES) = 0.76 and 1.98], clinical attachment level (Mean diff = -0.8±0.3 and -1.4±0.3, ES = 0.84 and 1.77) and plaque index (Mean diff = -0.5±0.2 and -0.7±0.2, ES = 0.93 and 1.81) at 3-month follow-up than the CG did. The AIHC group had a greater reduction in probing pocket depth (ES = 0.46) and clinical attachment level (ES = 0.64) at the 3-month follow-up compared with the AI group.
CONCLUSION


Using AI monitoring at home had a positive effect on treatment outcomes for patients with periodontitis. Patients with AI-assisted health counseling exhibited better treatment outcomes than did patients who used AI monitoring alone. This article is protected by copyright. All rights reserved.",2022,"The AIHC group had a greater reduction in probing pocket depth (ES = 0.46) and clinical attachment level (ES = 0.64) at the 3-month follow-up compared with the AI group.
","['Participants with periodontitis', 'Patients with Periodontitis', 'patients with periodontitis']","['AI and human counseling (AIHC; n\xa0=\xa017), or control (CG; n\xa0=\xa020) group', 'nonsurgical periodontal treatment', 'home AI-assisted dental monitoring application', '® (DM) intervention', 'Artificial Intelligence (AI)-Assisted Dental Monitoring Intervention']","['clinical attachment level', 'probing pocket depth', 'plaque index']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",,0.0567879,"The AIHC group had a greater reduction in probing pocket depth (ES = 0.46) and clinical attachment level (ES = 0.64) at the 3-month follow-up compared with the AI group.
","[{'ForeName': 'Kang-Ling', 'Initials': 'KL', 'LastName': 'Shen', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung City, Taiwan.'}, {'ForeName': 'Chiung-Lin', 'Initials': 'CL', 'LastName': 'Huang', 'Affiliation': 'Division of Periodontics, Department of Dentistry, Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan.'}, {'ForeName': 'Ying-Chun', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung City, Taiwan.'}, {'ForeName': 'Je-Kang', 'Initials': 'JK', 'LastName': 'Du', 'Affiliation': 'Department of Dentistry, Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan.'}, {'ForeName': 'Fu-Li', 'Initials': 'FL', 'LastName': 'Chen', 'Affiliation': 'Department of Public Health, Fu Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kabasawa', 'Affiliation': 'Oral Care for Systemic Health Support, Faculty of Dentistry, School of Oral Health Care Sciences, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Chih-Chang', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung City, Taiwan.'}, {'ForeName': 'Hsiao-Ling', 'Initials': 'HL', 'LastName': 'Huang', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung City, Taiwan.'}]",Journal of clinical periodontology,['10.1111/jcpe.13675']
2246,35713701,Fracture resistance and biomechanical behavior of different access cavities of maxillary central incisors restored with different composite resins.,"OBJECTIVES


The aim of this study was to compare the effect of three different access cavities on the tissue removal, deflection, fracture resistance, and stress distribution of extracted maxillary central incisors.
MATERIALS AND METHODS


Forty human maxillary central incisors were randomly assigned in four experimental group (n = 10) including conservative access cavity ""CAC,"" traditional access cavity ""TAC,"" invasive access cavity ""IAC,"" and without access cavity (control group). Cone-beam computed tomography ""CBCT"" scans were used to evaluate the tissue removal during the different access cavities. All specimens were restored with composite resin (Admira Fusion, Voco, Cuxhaven, Germany) and embedded in acrylic resin blocks after simulating the periodontal ligament using red wax, then the specimens were submitted to the deflection test applying a load of 250 N and to the load-to-fracture test after artificial aging in a mechanical cycling machine (150 N, 5 × 10 6  cycles, 10 Hz). Lastly, stress distribution was assessed by three-dimensional finite element analysis (3D-FEA), simulating the specimens restoration by two types of composite resins of low and high elastic modulus (8 and 18 GPa respectively) after the access cavities. The data were submitted to Shapiro-Wilk and KS normality tests. Then, they were analyzed by one-way ANOVA and Tukey tests with a significance level (α ≤ 0.05).
RESULTS


CBCT scans showed a significant difference of worn tissues in CAC and TAC when compared to the IAC (P < 0.0001). In deflection test, CAC showed lower deformation values than the TAC and IAC. Load-to-fracture test presented no significant difference among the three experimental groups (P = 0.6901). 3D-FEA showed that the more conservative the access cavity, the higher the stress magnitude.
CONCLUSIONS


CAC promote less worn tissue; however, this does not improve the stress distribution or fracture resistance of endodontically treated maxillary incisors.
CLINICAL RELEVANCE


Clinicians should reconsider the pros and cons of the conservative access cavity.",2022,Load-to-fracture test presented no significant difference among the three experimental groups (P = 0.6901).,['Forty human maxillary central incisors'],"['conservative access cavity ""CAC,"" traditional access cavity ""TAC,"" invasive access cavity ""IAC,"" and without access cavity (control group', 'Cone-beam computed tomography ""CBCT"" scans']","['worn tissues in CAC and TAC', 'Fracture resistance and biomechanical behavior', 'Lastly, stress distribution', 'deformation values', 'tissue removal, deflection, fracture resistance, and stress distribution of extracted maxillary central incisors', 'stress distribution or fracture resistance']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]",40.0,0.104485,Load-to-fracture test presented no significant difference among the three experimental groups (P = 0.6901).,"[{'ForeName': 'Amjad Abu', 'Initials': 'AA', 'LastName': 'Hasna', 'Affiliation': 'Department of Restorative Dentistry, Endodontics Division, Institute of Science and Technology (UNESP), São Paulo State University, Av. Francisco José Longo 777, São Dimas, São José dos Campos, SP, 12245-000, Brazil. d.d.s.amjad@gmail.com.'}, {'ForeName': 'Alana Barbosa Alves', 'Initials': 'ABA', 'LastName': 'Pinto', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology (UNESP), São Paulo State University, São José dos Campos, Brazil.'}, {'ForeName': 'Marcelle Simões', 'Initials': 'MS', 'LastName': 'Coelho', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology (UNESP), São Paulo State University, São José dos Campos, Brazil.'}, {'ForeName': 'Guilherme Schmitt', 'Initials': 'GS', 'LastName': 'de Andrade', 'Affiliation': 'School of Dentistry, Center of Biological and Health Sciences, Western Paraná State University (Unioeste), Cascavel, Brazil.'}, {'ForeName': 'João Paulo Mendes', 'Initials': 'JPM', 'LastName': 'Tribst', 'Affiliation': 'Department of Dental Materials, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, 1081 LA, Amsterdam, The Netherlands.'}, {'ForeName': 'Sergio Lucio Pereira', 'Initials': 'SLP', 'LastName': 'de Castro Lopes', 'Affiliation': 'Department of Biosciences and Oral Diagnosis, Institute of Science and Technology, São Paulo State University - UNESP, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Cláudio Antonio Talge', 'Initials': 'CAT', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative Dentistry, Endodontics Division, Institute of Science and Technology (UNESP), São Paulo State University, Av. Francisco José Longo 777, São Dimas, São José dos Campos, SP, 12245-000, Brazil.'}, {'ForeName': 'Alexandre Luiz Souto', 'Initials': 'ALS', 'LastName': 'Borges', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology (UNESP), São Paulo State University, São José dos Campos, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-022-04581-z']
2247,35713688,Feasibility and acceptability of a diagnostic randomized clinical trial of bowel ultrasound in infants with suspected necrotizing enterocolitis.,"We conducted a pilot diagnostic randomized clinical trial (RCT) to examine the feasibility, acceptability, and preliminary outcomes of adding bowel ultrasound (BUS) to the diagnostic evaluation for necrotizing enterocolitis (NEC). Infants ≤ 32 weeks' gestational age with NEC concern were randomized to undergo abdominal X-ray (AXR) or AXR + BUS. The primary outcome was study feasibility. Secondary outcomes included rates of NEC diagnosis and duration of treatment with bowel rest and antibiotics. A total of 56 infants were enrolled; 16 developed NEC concern and were randomized. Rates of recruitment (56/82 = 68%), retention (16/16 = 100%), and protocol compliance (126/127 = 99%) met pre-specified thresholds for feasibility. No significant differences in rates of NEC diagnosis were found between the two groups. Durations of bowel rest and antibiotic treatment were also similar.   Conclusion: Our study supports the feasibility of conducting a definitive diagnostic RCT to establish safety and efficacy of BUS for NEC.   Clinical trial registration: The study was registered at https://clinicaltrials.gov (NCT03963011). What is Known: • Bowel ultrasound (BUS) is increasingly being utilized as an adjunct to abdominal radiographs in evaluating for necrotizing enterocolitis (NEC). • The impact of BUS on patient outcomes is unknown. What is New: • A diagnostic randomized controlled trial study design to determine safety and effectiveness of adding BUS to NEC evaluation is feasible and acceptable.",2022,No significant differences in rates of NEC diagnosis were found between the two groups.,"[""Infants\u2009≤\u200932\xa0weeks' gestational age with NEC concern"", 'infants with suspected necrotizing enterocolitis', '56 infants were enrolled; 16 developed NEC concern and were randomized', 'necrotizing enterocolitis (NEC']","['• Bowel ultrasound (BUS', 'bowel ultrasound (BUS', 'abdominal X-ray (AXR) or AXR\u2009+\u2009BUS']","['rates of NEC diagnosis', 'rates of NEC diagnosis and duration of treatment with bowel rest and antibiotics', 'Feasibility and acceptability']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0034573', 'cui_str': 'Diagnostic radiography of abdomen'}]","[{'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",56.0,0.436882,No significant differences in rates of NEC diagnosis were found between the two groups.,"[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cuna', 'Affiliation': ""Division of Neonatology, Children's Mercy Kansas City, Kansas City, MO, USA. accuna@cmh.edu.""}, {'ForeName': 'Sherwin', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Sien', 'Affiliation': ""Department of Radiology, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': ""Department of Radiology, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Rao', 'Affiliation': ""Division of Neonatology, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Opfer', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",European journal of pediatrics,['10.1007/s00431-022-04526-4']
2248,35713670,Immune enhancement in patients with predicted severe acute necrotising pancreatitis: a multicentre double-blind randomised controlled trial.,"PURPOSE


Infected pancreatic necrosis (IPN) is a highly morbid complication of acute necrotising pancreatitis (ANP). Since there is evidence of early-onset immunosuppression in acute pancreatitis, immune enhancement may be a therapeutic option. This trial aimed to evaluate whether early immune-enhancing Thymosin alpha 1 (Tα1) treatment reduces the incidence of IPN in patients with predicted severe ANP.
METHODS


We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms. Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline). The primary outcome was the development of IPN during the index admission.
RESULTS


A total of 508 patients were randomised, of whom 254 were assigned to receive Tα1 and 254 placebo. The vast majority of the participants required admission to the intensive care unit (ICU) (479/508, 94.3%). During the index admission, 40/254(15.7%) patients in the Tα1 group developed IPN compared with 46/254 patients (18.1%) in the placebo group (difference -2.4% [95% CI - 7.4 to 5.1%]; p = 0.48). The results were similar across four predefined subgroups. There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15%), bleeding (6.3% vs. 3.5%), and gastrointestinal fistula (2% vs. 2.4%).
CONCLUSION


The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.",2022,The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.,"['patients with predicted severe acute necrotising pancreatitis', 'A total of 508 patients', 'ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score\u2009≥\u20098 and a computed tomography (CT) severity score\u2009≥\u20095 admitted within 7\xa0days of the advent of symptoms', 'patients with predicted severe ANP']","['placebo', 'subcutaneous injection of Tα1', 'early immune-enhancing Thymosin alpha 1 (Tα1', 'Tα1 and 254 placebo', 'placebos (normal saline']","['IPN', 'bleeding', 'incidence of IPN', 'development of IPN during the index admission', 'new-onset organ failure', 'gastrointestinal fistula', 'major complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0076612', 'cui_str': 'thymalfasin'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0341479', 'cui_str': 'Infected pancreatic necrosis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0079238', 'cui_str': 'Fistula of digestive system'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",508.0,0.619134,The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ke', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.'}, {'ForeName': 'Wenjian', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Nanjing Medical University, Nanjing, 210010, Jiangsu, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Public Health, Policy and Systems, Institute of Population Health, Whelan Building, Quadrangle, The University of Liverpool, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Pancreatic Disease Centre, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Xinting', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, 266000, Shandong, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Department of Critical Care Medicine, The Affiliated Hospital of Zunyi Medical University, Zunyi, 536000, Guizhou, China.'}, {'ForeName': 'Vikesh', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Pancreatitis Centre, Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Buxbaum', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Doig', 'Affiliation': 'Northern Clinical School, Royal, North Shore Hospital, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Chengjian', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Critical Care Medicine, the Affiliated Nanhua Hospital, University of South China, Hengyang, 421002, Hunan, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': 'Department of Critical Care Medicine, Affiliated Hospital 2 of Nantong University, Nantong, 226000, Jiangsu, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Intensive Care Unit, The First Affiliated Hospital of Wannan Medical College, Wuhu, 241001, Anhui, China.'}, {'ForeName': 'Shumin', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': ""Department of Emergency Medicine, Shangqiu First People's Hospital, Shangqiu, 476000, Henan, China.""}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Department of Emergency Medicine, Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine, Nanjing, 210010, Jiangsu, China.'}, {'ForeName': 'Guoxiu', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, The First Affiliated Hospital and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, 471003, Henan, China.'}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Intensive Care Unit, Qilu Hospital of Shandong University, Qingdao, 266000, Shandong, China.'}, {'ForeName': 'Junli', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Intensive Care Unit, Luoyang Central Hospital, Zhengzhou University, Luoyang, 471100, Henan, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Clinical Medical College, Yangzhou University, Yangzhou, Jiangsu, China.'}, {'ForeName': 'Jingchun', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Critical Care Medicine, 94Th Hospital of PLA, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Shao', 'Affiliation': 'Department of Intensive Care Unit, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Tu', 'Affiliation': ""Department of Emergency Medicine, Zhejiang Provincial People's Hospital, Hangzhou, 310014, Zhejiang, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Pancreatic Disease Centre, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Pancreatic Disease Centre, Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Qingyun', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, 266000, Shandong, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, The Affiliated Hospital of Zunyi Medical University, Zunyi, 536000, Guizhou, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Critical Care Medicine, the Affiliated Nanhua Hospital, University of South China, Hengyang, 421002, Hunan, China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Intensive Care Unit, The First Affiliated Hospital of Wannan Medical College, Wuhu, 241001, Anhui, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': ""Department of Emergency Medicine, Shangqiu First People's Hospital, Shangqiu, 476000, Henan, China.""}, {'ForeName': 'Wendi', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Medical School of Southeast University, Nanjing, 210002, Jiangsu, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.'}, {'ForeName': 'Baiqiang', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China. njzyantol@aliyun.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Windsor', 'Affiliation': 'Surgical and Translational Research Centre, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1142, New Zealand.'}, {'ForeName': 'Yuxiu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China.'}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu, China. ctgchina@medbit.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-022-06745-7']
2249,35713650,Effects of warm-up exercises on self-assessed vocal effort.,"PURPOSE


An elevated sense of vocal effort due to increased vocal demand is frequently reported by patients with voice disorders. However, effects of vocal warm-up on self-assessed vocal effort have not been thoroughly examined. A recently developed version of the Borg CR-10 Scale facilitates vocal effort assessments, following different vocal warm-up tasks.
METHODS


Effects of a short (5 min) vocal warm-up on self-assessed vocal effort was evaluated using the Borg CR-10. Twenty-six vocally healthy participants (13F, 13M, mean age 22.6), in two randomised groups, underwent sessions of either reading aloud or semi-occluded vocal tract exercises (SOVTE). Vocal effort was evaluated at four times: pre to post vocal warm-up and two silence periods. Non-parametric analyses for repeated measures and calculations for within-subject standard deviation were applied in group comparisons.
RESULTS


Following vocal warm-up, vocal effort ratings were increased to a statistically significant degree in both intervention groups compared to baseline ratings. After a 5-min rest in silence following completion of the vocal warm-up, vocal effort ratings returned to baseline levels in both groups. The drop in ratings immediately post warm-up compared to 5 min later was statistically significant for the SOVTE group.
CONCLUSIONS


Five minutes of vocal warm-up caused increased self-perceived vocal effort in vocally healthy individuals. The increased sense of effort dissipated faster following warm-up for the SOVTE group. When using the Borg CR-10 scale to track vocal effort, it may be beneficial to apply experience-based anchors.",2022,"Following vocal warm-up, vocal effort ratings were increased to a statistically significant degree in both intervention groups compared to baseline ratings.","['Twenty-six vocally healthy participants (13F, 13M, mean age 22.6', 'patients with voice disorders', 'vocally healthy individuals']","['warm-up exercises', 'reading aloud or semi-occluded vocal tract exercises (SOVTE', 'short (5\u2009min) vocal warm-up on self-assessed vocal effort']","['vocal demand', 'self-perceived vocal effort', 'self-assessed vocal effort', 'vocal effort ratings']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",26.0,0.0285959,"Following vocal warm-up, vocal effort ratings were increased to a statistically significant degree in both intervention groups compared to baseline ratings.","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Whitling', 'Affiliation': 'Department of Logopedics Phoniatrics and Audiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'School of Education Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Berardi', 'Affiliation': 'Vocal Control & Vocal Well-Being Lab, University Hospital, Bonn, Germany.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Hunter', 'Affiliation': 'Department of Clinical Sciences and Disorders, Michigan State University, East Lansing, MI, USA.'}]","Logopedics, phoniatrics, vocology",['10.1080/14015439.2022.2075459']
2250,35713632,Circulating tumor DNA (ctDNA) kinetics predict progression-free and overall survival in EGFR TKI-treated patients with EGFR-mutant NSCLC (SWOG S1403).,"PURPOSE


Dynamic changes in circulating tumor DNA (ctDNA) are under investigation as an early indicator of treatment outcome.
EXPERIMENTAL DESIGN


Serial plasma ctDNA (baseline, 8 weeks and at progression) was prospectively incorporated into the SWOG S1403 clinical trial of afatinib +/- cetuximab in TKI-naive, EGFR-mutation tissue-positive NSCLC.
RESULTS


EGFR mutations were detected in baseline ctDNA in 77% (82/106) of patients, associated with the presence of brain and/or liver metastases and M1B stage. Complete clearance of EGFR-mutations in ctDNA by 8 weeks was associated with a significantly decreased risk of progression, compared to those with persistent ctDNA at C3D1 (HR (95% CI): 0.23 (0.12-0.45), p<0.0001); with a median PFS of 15.1 (95% CI: 10.6-17.5) months in the group with clearance of ctDNA versus 4.6 (1.7-7.5) months in the group with persistent ctDNA. Clearance was also associated with a decreased risk of death (HR (95% CI): 0.44 (0.21-0.90), p=0.02; mOS: 32.6 versus 15.6 (4.9-28.3) months.
CONCLUSIONS


Plasma clearance of mutant EGFR ctDNA at 8-weeks was highly and significantly predictive of progression-free and overall survival, outperforming RECIST response for predicting long-term benefit.",2022,"Complete clearance of EGFR-mutations in ctDNA by 8 weeks was associated with a significantly decreased risk of progression, compared to those with persistent ctDNA at C3D1 (HR (95% CI): 0.23 (0.12-0.45), p<0.0001); with a median PFS of 15.1 (95% CI: 10.6-17.5) months in the group with clearance of ctDNA versus 4.6 (1.7-7.5) months in the group with persistent ctDNA.",[],"['afatinib ', 'cetuximab']","['progression-free and overall survival, outperforming RECIST response', 'risk of death', 'Complete clearance of EGFR-mutations', 'risk of progression', 'Circulating tumor DNA (ctDNA) kinetics predict progression-free and overall survival', 'Clearance']",[],"[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",,0.29424,"Complete clearance of EGFR-mutations in ctDNA by 8 weeks was associated with a significantly decreased risk of progression, compared to those with persistent ctDNA at C3D1 (HR (95% CI): 0.23 (0.12-0.45), p<0.0001); with a median PFS of 15.1 (95% CI: 10.6-17.5) months in the group with clearance of ctDNA versus 4.6 (1.7-7.5) months in the group with persistent ctDNA.","[{'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Mack', 'Affiliation': 'Mount Sinai School of Medicine, New York, NY, United States.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'Fred Hutchinson Cancer Center, Seattle, WA, United States.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Fred Hutchinson Cancer Research Center, United States.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut, United States.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Melnick', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Zenta', 'Initials': 'Z', 'LastName': 'Walther', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Fred R', 'Initials': 'FR', 'LastName': 'Hirsch', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Politi', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, United States.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, United States.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-22-0741']
2251,35713536,"Corrigendum to: Authors' Response to the Letter to the Editor on ""The MOTION Study: A Randomized Controlled Trial with Objective Real-World Outcomes for Lumbar Spinal Stenosis Patients Treated with the mild® Procedure: One-Year Results"".",,2022,,['Lumbar Spinal Stenosis Patients Treated with the mild® Procedure'],[],[],"[{'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],[],,0.0662725,,[],"Pain medicine (Malden, Mass.)",['10.1093/pm/pnac097']
2252,35713526,"On ""Effectiveness of High-Frequency Transcranial Magnetic Stimulation and Physical Exercise in Women with Fibromyalgia: a Randomized Controlled Trial."" Izquierdo-Alventosa R, Inglés M, Cortés-Amador S, Gimeno-Mallench L, Sempere-Rubio N, Serra-Añó P. Phys Ther. 2021;101:pzab159.",,2022,,['Women with Fibromyalgia'],['High-Frequency Transcranial Magnetic Stimulation and Physical Exercise'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0608165,,"[{'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'İlgen', 'Affiliation': 'Rheumatology Clinic, Tatvan State Hospital, 13200 Tatvan, Bitlis, Turkey.'}]",Physical therapy,['10.1093/ptj/pzac071']
2253,35713517,Neoadjuvant Trastuzumab and Pyrotinib for Locally Advanced HER2-Positive Breast Cancer (NeoATP): Primary Analysis of a Phase II Study.,"PURPOSE


Despite accumulating evidence on dual blockade of human epidermal growth factor receptor 2 (HER2) for locally advanced HER2-positive breast cancer, no robust evidence supports the addition of pyrotinib to trastuzumab in the neoadjuvant setting. The NeoATP trial aimed to evaluate the efficacy and safety of pyrotinib with neoadjuvant trastuzumab and chemotherapy.
METHODS


The phase II NeoATP trial included female patients with histologically confirmed stage IIA-IIIC and HER2-positive primary invasive breast cancer. Eligible patients received pyrotinib and trastuzumab with weekly paclitaxel-cisplatin neoadjuvant chemotherapy for four cycles. The primary endpoint was pathological complete response (pCR; ypT0 ypN0) rate. Key secondary endpoints included locoregional pCR (ypT0/is ypN0) rate, biomarker analysis and safety.
RESULTS


Among 53 enrolled patients (median age, 47 years; 73.58% stage III), 52 completed the study treatment and surgery. Overall, 37 patients (69.81%) achieved pCR. For women with hormone receptor negative and positive tumors, the pCR rates were 85.71% and 59.38% (P = 0.041), while the corresponding rates were 69.23% and 70.00% respectively for those with and without PIK3CA mutation (P = 0.958). The most frequently reported grade 3 to 4 adverse events were diarrhea (45.28%), leukopenia (39.62%) and neutropenia (32.08%). No deaths occurred, and no left ventricular ejection fraction <50% or >10 points drop from baseline to before surgery was reported.
CONCLUSIONS


The addition of pyrotinib to trastuzumab plus chemotherapy is an efficacious and safe regimen for patients with HER2-positive locally advanced breast cancer in the neoadjuvant setting. The randomized controlled clinical trial is warranted to validate our results.",2022,"No deaths occurred, and no left ventricular ejection fraction <50% or >10 points drop from baseline to before surgery was reported.
","['locally advanced HER2-positive breast cancer', '53 enrolled patients (median age, 47 years; 73.58% stage III), 52 completed the study treatment and surgery', 'patients with HER2-positive locally advanced breast cancer in the neoadjuvant setting', 'female patients with histologically confirmed stage IIA-IIIC and HER2-positive primary invasive breast cancer', 'Locally Advanced HER2-Positive Breast Cancer (NeoATP']","['Neoadjuvant Trastuzumab and Pyrotinib', 'trastuzumab plus chemotherapy', 'pyrotinib and trastuzumab with weekly paclitaxel-cisplatin neoadjuvant chemotherapy', 'pyrotinib with neoadjuvant trastuzumab and chemotherapy']","['pCR', 'diarrhea', 'leukopenia', 'efficacy and safety', 'pCR rates', 'left ventricular ejection fraction', 'pathological complete response (pCR; ypT0 ypN0) rate', 'deaths', 'neutropenia', 'locoregional pCR (ypT0/is ypN0) rate, biomarker analysis and safety']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441768', 'cui_str': 'Stage 2A'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0672257', 'cui_str': 'TP protocol'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",53.0,0.176961,"No deaths occurred, and no left ventricular ejection fraction <50% or >10 points drop from baseline to before surgery was reported.
","[{'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Yaohui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Ziping', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Yumei', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Liheng', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, China.'}, {'ForeName': 'Yueyao', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, P.R. China, Shanghai, China.'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-22-0446']
2254,35713466,Duration of Heart Failure With Reduced Ejection Fraction Associated With Electrocardiographic Outcomes Before and After Sacubitril/Valsartan.,"AIM


Changes in QRS duration in patients with heart failure with reduced ejection fraction (HFrEF) after sacubitril/valsartan therapy is not fully understood. This study aimed to assess the association of duration of HFrEF diagnosis with electrocardiographic and echocardiographic outcomes between before and after sacubitril/valsartan.
METHODS


We included HFrEF patients who received naïve sacubitril/valsartan therapy for ≥3 months, between January 2016 and March 2018. All patients were divided into 2 groups based on their duration of HFrEF. Generalized linear models were analyzed the cardiac outcomes after sacubitril/valsartan therapy by HFrEF duration.
RESULTS


Among these, 42 patients were HFrEF duration of <1 year and 47 patients were ≥1 year. The mean difference of QRS duration was lesser in the <1-year group than in the ≥1-year group (-2.3 msec vs 6.3 msec;  P  = .029). However, the mean difference of left ventricular ejection fraction (LVEF) was higher in the ≥1-year group (13.8% vs 5.8%;  P  = .008). After adjusting for patient demographics and clinical characteristics, the ≥1-year group had a significantly prolonged QRS duration (coefficient = 11; 95% confidence interval [CI], 0.3-21.7) and an unfavorable LVEF recovery (coefficient = -10.3; 95% CI -14.5 to -6.1) compared with the <1-year group.
CONCLUSION


Prolonged QRS durations and unfavorable LVEF recoveries after sacubitril/valsartan therapy were observed in patients with HFrEF duration of ≥1 year. Earlier diagnosis of HFrEF and appropriate medication treatment may be beneficial in the improvement of QRS duration and LVEF recovery.",2022,The mean difference of QRS duration was lesser in the <1-year group than in the ≥1-year group (-2.3 msec vs 6.3 msec;  P  = .029).,"['for ≥3 months, between January 2016 and March 2018', 'patients with heart failure with reduced ejection fraction (HFrEF) after sacubitril', 'HFrEF patients who received', '42 patients were HFrEF duration of <1 year and 47 patients were ≥1 year', 'patients with HFrEF duration of ≥1 year']","['naïve sacubitril/valsartan therapy', 'valsartan therapy', 'sacubitril/valsartan', 'Sacubitril/Valsartan']","['left ventricular ejection fraction (LVEF', 'prolonged QRS duration', 'QRS duration and LVEF recovery', 'Duration of Heart Failure', 'QRS durations and unfavorable LVEF recoveries', 'QRS duration', 'unfavorable LVEF recovery']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0429025', 'cui_str': 'QRS complex duration'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",,0.0889092,The mean difference of QRS duration was lesser in the <1-year group than in the ≥1-year group (-2.3 msec vs 6.3 msec;  P  = .029).,"[{'ForeName': 'Po-Lin', 'Initials': 'PL', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, 156934Hsinchu MacKay Memorial Hospital, Hsinchu.'}, {'ForeName': 'Ying-Hsiang', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Cardiovascular Center, 117127MacKay Memorial Hospital, Taipei.'}, {'ForeName': 'Lawrence Yu-Min', 'Initials': 'LY', 'LastName': 'Liu', 'Affiliation': 'Division of Cardiology, 156934Hsinchu MacKay Memorial Hospital, Hsinchu.'}, {'ForeName': 'Cheng-Ting', 'Initials': 'CT', 'LastName': 'Tsai', 'Affiliation': 'Cardiovascular Center, 117127MacKay Memorial Hospital, Taipei.'}, {'ForeName': 'Ten-Fang', 'Initials': 'TF', 'LastName': 'Yang', 'Affiliation': 'Department of Biological Science and Technology, 34914National Yang Ming Chiao-Tung University, Hsinchu.'}, {'ForeName': 'Wei-Ru', 'Initials': 'WR', 'LastName': 'Chiou', 'Affiliation': 'Department of Medicine, 117127Mackay Medical College, New Taipei.'}, {'ForeName': 'Mu-Yang', 'Initials': 'MY', 'LastName': 'Hsieh', 'Affiliation': 'Department of Biological Science and Technology, 34914National Yang Ming Chiao-Tung University, Hsinchu.'}, {'ForeName': 'Hung-Yu', 'Initials': 'HY', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, Heart Centre, 38007Cheng Hsin General Hospital, Taipei.'}, {'ForeName': 'Chun-Che', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Healthcare Administration, 145713I-Shou University, Kaohsiung.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/10742484221107799']
2255,35713955,Feasibility of Using Games to Improve Healthy Lifestyle Knowledge in Youth Aged 9-16 Years at Risk for Type 2 Diabetes: Pilot Randomized Controlled Trial.,"BACKGROUND


Mobile games can be effective and motivating tools for promoting children's health.
OBJECTIVE


We aimed to determine the comparative use of 2 prototype serious games for health and assess their effects on healthy lifestyle knowledge in youth aged 9-16 years at risk for type 2 diabetes (T2D).
METHODS


A 3-arm parallel pilot randomized controlled trial was undertaken to determine the feasibility and preliminary effectiveness of 2 serious games. Feasibility aspects included recruitment, participant attitudes toward the games, the amount of time the participants played each game at home, and the effects of the games on healthy lifestyle and T2D knowledge. Participants were allocated to play Diabetic Jumper (n=7), Ari and Friends (n=8), or a control game (n=8). All participants completed healthy lifestyle and T2D knowledge questionnaires at baseline, immediately after game play, and 4 weeks after game play. Game attitudes and preferences were also assessed. The primary outcome was the use of the game (specifically, the number of minutes played over 4 weeks).
RESULTS


In terms of feasibility, we were unable to recruit our target of 60 participants. In total, 23 participants were recruited. Participants generally viewed the games positively. There were no statistical differences in healthy lifestyle knowledge or diabetes knowledge over time or across games. Only 1 participant accessed the game for an extended period, playing the game for a total of 33 min over 4 weeks.
CONCLUSIONS


It was not feasible to recruit the target sample for this trial. The 2 prototype serious games were unsuccessful at sustaining long-term game play outside a clinic environment. Based on positive participant attitudes toward the games, it is possible to use these games or similar games as short-term stimuli to engage young people with healthy lifestyle and diabetes knowledge in a clinic setting; however, future research is required to explore this area.
TRIAL REGISTRATION


Australia New Zealand Clinical Trials Registry ACTRN12619000380190; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377123.",2022,There were no statistical differences in healthy lifestyle knowledge or diabetes knowledge over time or across games.,"['60 participants', 'Aged 9-16 Years at Risk for Type 2 Diabetes', '23 participants were recruited', 'Youth', 'youth aged 9-16 years at risk for type 2 diabetes (T2D']","['control game', 'play Diabetic Jumper']","['healthy lifestyle and T2D knowledge questionnaires', 'healthy lifestyle knowledge or diabetes knowledge', 'healthy lifestyle and T2D knowledge', 'use of the game (specifically, the number of minutes played over 4 weeks', 'healthy lifestyle knowledge']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0542352', 'cui_str': 'Pullover'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1562039', 'cui_str': 'Number of minutes'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439230', 'cui_str': 'week'}]",23.0,0.111354,There were no statistical differences in healthy lifestyle knowledge or diabetes knowledge over time or across games.,"[{'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}, {'ForeName': 'Nilufar', 'Initials': 'N', 'LastName': 'Baghaei', 'Affiliation': 'Games and Extended Reality Lab, Massey University, Auckland, New Zealand.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Calder', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, Middlemore Hospital, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Parag', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ihirangi', 'Initials': 'I', 'LastName': 'Heke', 'Affiliation': 'Heke Consulting, Auckland, New Zealand.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Dobson', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Marsh', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}]",JMIR formative research,['10.2196/33089']
2256,35713950,Progesterone increases nicotine withdrawal and anxiety in male but not female smokers during brief abstinence.,"INTRODUCTION


Although exogenous progesterone may hold promise as a treatment for nicotine use disorders, it is unclear whether it is similarly effective in males and females. This study examined the effects of progesterone on nicotine use disorder comprehensively using behavioral, psychological, and neural measures in male and female smokers exposed to brief abstinence.
METHODS


Thirty-three male and 33 female non-treatment-seeking smokers participated in a double-blind, randomized, placebo-controlled crossover study of 200mg of progesterone or placebo daily over a four-day abstinence period. Smoking behavior and subjective effects of nicotine were assessed at baseline and after final drug administration. Nicotine withdrawal, smoking urges, mood states, and neural response to smoking cues were measured at baseline, after the first drug administration, and after the final drug administration.
RESULTS


No main effect of drug (progesterone vs. placebo) emerged for any outcome. Significant sex by drug interactions emerged for nicotine withdrawal (p = 0.020), perceived strength of nicotine (p = 0.040), and perceived bad effects of nicotine (p = 0.029). Males receiving progesterone reported worse nicotine withdrawal (p = 0.046) and a trend towards decreased bad effects of nicotine (p = 0.070). Males on progesterone also reported greater tension and anxiety relative to placebo (p = 0.021). Females on progesterone perceived nicotine's effects as being stronger relative to placebo (p = 0.046).
CONCLUSIONS


Progesterone causes sex-dependent effects on smoking-related outcomes during brief abstinence. Specifically, progesterone in males may increase rather than decrease nicotine withdrawal and negative affect during abstinence, potentially hindering efforts to quit smoking.
IMPLICATIONS


In male and female smokers undergoing a brief period of abstinence, we examined the effects of progesterone on smoking outcomes. While progesterone had limited effects in female smokers, in males, it worsened nicotine withdrawal and negative affect. Our findings emphasize the importance of analyzing sex differences in future studies examining progesterone as a potential treatment and suggest that progesterone in males could potentially exacerbate aspects of nicotine dependence.",2022,Males receiving progesterone reported worse nicotine withdrawal (p = 0.046) and a trend towards decreased bad effects of nicotine (p = 0.070).,"['males and females', 'male and female smokers', 'male and female smokers undergoing a brief period of abstinence', 'male but not female smokers', 'Thirty-three male and 33 female non-treatment-seeking smokers']","['progesterone or placebo', 'exogenous progesterone', 'Progesterone', 'drug (progesterone vs. placebo', 'progesterone', 'placebo']","['nicotine withdrawal', 'tension and anxiety relative', 'Nicotine withdrawal, smoking urges, mood states, and neural response to smoking cues', 'nicotine withdrawal and anxiety', 'Smoking behavior and subjective effects of nicotine', 'perceived strength of nicotine']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0425946', 'cui_str': 'Short menstrual periods'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",33.0,0.040854,Males receiving progesterone reported worse nicotine withdrawal (p = 0.046) and a trend towards decreased bad effects of nicotine (p = 0.070).,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Novick', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Korrina A', 'Initials': 'KA', 'LastName': 'Duffy', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado-Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kuzma', 'Affiliation': 'Larner College of Medicine, University of Vermont, Burlington, VM.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Loughead', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'C Neill', 'Initials': 'CN', 'LastName': 'Epperson', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, CO 80045, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntac146']
2257,35713944,The Impact of Mobile Health Use on the Self-care of Patients With Type 2 Diabetes: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Chronic diseases are a substantial public health issue worldwide and affect an individual's quality of life. Due to the alarming rise in type 2 diabetes, health care that was primarily focused on diagnosis and treatment of the disease is increasingly focused on prevention and self-care. Patients who adhere to a constant and strict treatment regimen (physical activity, diet, medication) and regularly monitor their health are more likely to maintain self-care and health, prevent the exacerbation of the disease, and avoid the complications of diabetes (retinopathy, diabetic feet, etc). In recent years, many innovative devices that have become increasingly present in inpatient health care, such as mobile apps, are available to help patients maintain consistency in monitoring their health status. Mobile apps make it easier for individuals to monitor their self-care and illness and follow instructions regarding disease control.
OBJECTIVE


This study aims to determine the impact of mobile app use on self-care in patients with type 2 diabetes. We will evaluate and test the usefulness of the forDiabetes app as a tool to improve the self-care of individuals with type 2 diabetes.
METHODS


We will perform a double-blind randomized controlled trial. The study will include individuals aged over 18 years diagnosed with or have regulated type 2 diabetes who are treated in family medicine practices. Additionally, the individuals included in the study should not have any acute complications due to the consequences of type 2 diabetes. They will use an Android or iOS mobile phone and a blood glucose meter during the investigation. With the help of simple randomization, individuals will be divided into the intervention and control groups. Individuals in the intervention group will use the forDiabetes mobile app to monitor their self-care for type 2 diabetes. Individuals in the control group will not receive a particular intervention. Data will be collected using the Self-care of Diabetes Inventory questionnaire and Brief Illness Perception Questionnaire. Blood sugar, blood pressure, glycated hemoglobin (HbA 1c ), and weight measurements will be monitored using calibrated instruments during the study by the nurses employed at the family medicine practice. Data will be collected at the beginning of the study and after a patient visits the family medicine practice.
RESULTS


In the first half of 2020, we have prepared a translation of the mobile app that will be used by the participants of the intervention group, as well as more detailed instructions for using the app. We have also prepared a translation of the questionnaires in Slovene. The research results will be published in 2023.
CONCLUSIONS


This research contributes to greater visibility and usability of mobile apps for the self-care of patients with type 2 diabetes and raises awareness of the possible use of innovative methods.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04999189; https://clinicaltrials.gov/ct2/show/NCT04999189.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/31652.",2022,Individuals in the intervention group will use the forDiabetes mobile app to monitor their self-care for type 2 diabetes.,"['individuals aged over 18 years diagnosed with or have regulated type 2 diabetes who are treated in family medicine practices', 'patients with type 2 diabetes', 'Patients who adhere to a constant and strict treatment regimen (physical activity, diet, medication) and regularly monitor their health', 'Patients With Type 2 Diabetes', 'individuals with type 2 diabetes']",['forDiabetes mobile app to monitor their self-care'],"['Blood sugar, blood pressure, glycated hemoglobin (HbA 1c ), and weight measurements']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}]",,0.0786324,Individuals in the intervention group will use the forDiabetes mobile app to monitor their self-care for type 2 diabetes.,"[{'ForeName': 'Lucija', 'Initials': 'L', 'LastName': 'Gosak', 'Affiliation': 'Faculty of Health Sciences, University of Maribor, Maribor, Slovenia.'}, {'ForeName': 'Majda', 'Initials': 'M', 'LastName': 'Pajnkihar', 'Affiliation': 'Faculty of Health Sciences, University of Maribor, Maribor, Slovenia.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Stiglic', 'Affiliation': 'Faculty of Health Sciences, University of Maribor, Maribor, Slovenia.'}]",JMIR research protocols,['10.2196/31652']
2258,35713933,Aerobic exercise training and neurocognitive function in cognitively normal older adults: A one-year randomized controlled trial.,"BACKGROUND


Current evidence is inconsistent on the benefits of aerobic exercise training for preventing or attenuating age-related cognitive decline in older adults.
OBJECTIVE


To investigate the effects of a one-year progressive, moderate-to-high intensity aerobic exercise intervention on cognitive function, brain volume, and cortical thickness in sedentary but otherwise healthy older adults.
METHODS


We randomized 73 older adults to a one-year aerobic exercise or stretching-and-toning (active control) program. The primary outcome was a cognitive composite score calculated from eight neuropsychological tests encompassing inductive reasoning, long-term and working memory, executive function, and processing speed. Secondary outcomes were brain volume and cortical thickness assessed by MRI, and cardiorespiratory fitness measured by peak oxygen uptake (VO 2  ).
RESULTS


One-year aerobic exercise increased peak VO 2  by ∼10% (p<0.001) while it did not change with stretching (p = 0.241). Cognitive composite scores increased in both the aerobic and stretching groups (p<0.001 for time effect), although no group difference was observed. Total brain volume (p<0.001) and mean cortical thickness (p = 0.001) decreased in both groups over time while the reduction in hippocampal volume was smaller in the stretching group compared with the aerobic group (p = 0.040 for interaction). Across all participants, improvement in peak VO 2  was positively correlated with increases in cognitive composite score (r = 0.282, p = 0.042) and regional cortical thickness at the inferior parietal lobe (p = 0.016).
CONCLUSIONS


One-year aerobic exercise and stretching interventions improved cognitive performance but did not prevent age-related brain volume loss in sedentary healthy older adults. Cardiorespiratory fitness gain was positively correlated with cognitive performance and regional cortical thickness. This article is protected by copyright. All rights reserved.",2022,Total brain volume (p<0.001) and mean cortical thickness (p = 0.001) decreased in both groups over time while the reduction in hippocampal volume was smaller in the stretching group compared with the aerobic group (p = 0.040 for interaction).,"['sedentary healthy older adults', '73 older adults to a one-year', 'sedentary but otherwise healthy older adults', 'cognitively normal older adults', 'older adults']","['aerobic exercise and stretching interventions', 'one-year progressive, moderate-to-high intensity aerobic exercise intervention', 'Aerobic exercise training', 'aerobic exercise training', 'aerobic exercise or stretching-and-toning (active control) program']","['cognitive performance and regional cortical thickness', 'peak VO', 'Cognitive composite scores', 'Cardiorespiratory fitness gain', 'hippocampal volume', 'brain volume and cortical thickness assessed by MRI, and cardiorespiratory fitness measured by peak oxygen uptake (VO 2  ', 'cognitive function, brain volume, and cortical thickness', 'cognitive composite score', 'Total brain volume (p<0.001) and mean cortical thickness', 'cognitive performance', 'cognitive composite score calculated from eight neuropsychological tests encompassing inductive reasoning, long-term and working memory, executive function, and processing speed', 'regional cortical thickness']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]",73.0,0.0607267,Total brain volume (p<0.001) and mean cortical thickness (p = 0.001) decreased in both groups over time while the reduction in hippocampal volume was smaller in the stretching group compared with the aerobic group (p = 0.040 for interaction).,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Neena R', 'Initials': 'NR', 'LastName': 'Patel', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Tomoto', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Pasha', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Ayaz M', 'Initials': 'AM', 'LastName': 'Khan', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Kostroske', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Tinajero', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Ciwen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Hynan', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Rodrigue', 'Affiliation': 'Center for Vital Longevity, School of Behavioral and Brain Sciences, The University of Texas at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Kennedy', 'Affiliation': 'Center for Vital Longevity, School of Behavioral and Brain Sciences, The University of Texas at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Denise C', 'Initials': 'DC', 'LastName': 'Park', 'Affiliation': 'Center for Vital Longevity, School of Behavioral and Brain Sciences, The University of Texas at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, USA.'}]",Journal of internal medicine,['10.1111/joim.13534']
2259,35713906,Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial.,"Importance


COVID-19 morbidity is highest in Black and Latino older adults. These racial and ethnic groups initially had lower vaccination uptake than others, and rates in Black adults continue to lag.
Objectives


To evaluate the effect of outreach via electronic secure messages and mailings from primary care physicians (PCPs) on COVID-19 vaccination uptake among Black and Latino older adults and to compare the effects of culturally tailored and standard PCP messages.
Design, Setting, and Participants


This randomized clinical trial was conducted from March 29 to May 20, 2021, with follow-up surveys through July 31, 2021. Latino and Black individuals aged 65 years and older from 4 Kaiser Permanente Northern California (KPNC) service areas were included. Data were analyzed from May 27, 2021, to September 28, 2021.
Interventions


Individuals who had not received COVID-19 vaccination after previous outreach were randomized to electronic secure message and/or mail outreach from their PCP, similar outreach with additional culturally tailored content, or usual care. Outreach groups were sent a secure message or letter in their PCP's name, followed by a postcard to those still unvaccinated after 4 weeks.
Main Outcomes and Measures


The primary outcome was time to receipt of COVID-19 vaccination during the 8 weeks after initial study outreach. KPNC data were supplemented with state data from external sources. Intervention effects were evaluated via proportional hazards regression.
Results


Of 8287 included individuals (mean [SD] age, 72.6 [7.0] years; 4665 [56.3%] women), 2434 (29.4%) were Black, 3782 (45.6%) were Latino and preferred English-language communications, and 2071 (25.0%) were Latino and preferred Spanish-language communications; 2847 participants (34.4%) had a neighborhood deprivation index at the 75th percentile or higher. A total of 2767 participants were randomized to culturally tailored PCP outreach, 2747 participants were randomized to standard PCP outreach, and 2773 participants were randomized to usual care. Culturally tailored PCP outreach led to higher COVID-19 vaccination rates during follow-up compared with usual care (664 participants [24.0%] vs 603 participants [21.7%]; adjusted hazard ratio (aHR), 1.22; 95% CI, 1.09-1.37), as did standard PCP outreach (635 participants [23.1%]; aHR, 1.17; 95% CI, 1.04-1.31). Individuals who were Black (aHR, 1.19; 95% CI, 1.06-1.33), had high neighborhood deprivation (aHR, 1.17; 95% CI, 1.03-1.33), and had medium to high comorbidity scores (aHR, 1.19; 95% CI, 1.09-1.31) were more likely to be vaccinated during follow-up.
Conclusions and Relevance


This randomized clinical trial found that PCP outreach using electronic and mailed messages increased COVID-19 vaccination rates among Black and Latino older adults.
Trial Registration


ClinicalTrials.gov Identifier: NCT05096026.",2022,"Culturally tailored PCP outreach led to higher COVID-19 vaccination rates during follow-up compared with usual care (664 participants [24.0%] vs 603 participants [21.7%]; adjusted hazard ratio (aHR), 1.22; 95% CI, 1.09-1.37), as did standard PCP outreach (635 participants [23.1%]; aHR, 1.17; 95% CI, 1.04-1.31).","['2847 participants (34.4%) had a neighborhood deprivation index at the 75th percentile or higher', 'Latino and Black individuals aged 65 years and older from 4 Kaiser Permanente Northern California (KPNC) service areas were included', 'March 29 to May 20, 2021, with follow-up surveys through July 31, 2021', 'Black and Latino Older Adults', '8287 included individuals (mean [SD] age, 72.6 [7.0] years; 4665 [56.3%] women), 2434 (29.4%) were Black, 3782 (45.6%) were Latino and preferred English-language communications, and 2071 (25.0%) were Latino and preferred Spanish-language communications', 'Black and Latino older adults', '2767 participants were randomized to culturally tailored PCP outreach, 2747 participants were randomized to standard PCP outreach, and 2773 participants were randomized to usual care', 'Interventions\n\n\nIndividuals who had not received COVID-19 vaccination after previous outreach']","['Electronic and Mail Outreach From Primary Care Physicians', 'culturally tailored and standard PCP messages', 'outreach via electronic secure messages and mailings from primary care physicians (PCPs', 'electronic secure message and/or mail outreach from their PCP, similar outreach with additional culturally tailored content, or usual care']","['high neighborhood deprivation', 'COVID-19 vaccination rates', 'time to receipt of COVID-19 vaccination']","[{'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",2767.0,0.542275,"Culturally tailored PCP outreach led to higher COVID-19 vaccination rates during follow-up compared with usual care (664 participants [24.0%] vs 603 participants [21.7%]; adjusted hazard ratio (aHR), 1.22; 95% CI, 1.09-1.37), as did standard PCP outreach (635 participants [23.1%]; aHR, 1.17; 95% CI, 1.04-1.31).","[{'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Lieu', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Elkin', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Escobar', 'Affiliation': 'TPMG Health Engagement Consulting Services, Oakland, California.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Finn', 'Affiliation': 'TPMG Consulting Services, Oakland, California.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Klein', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Cimone', 'Initials': 'C', 'LastName': 'Durojaiye', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Prausnitz', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Sawyer', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Teran', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Goler', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Parodi', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Yi-Fen Irene', 'Initials': 'YI', 'LastName': 'Chen', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.17004']
2260,35713888,Baroreflex activation therapy with the barostim™ device in patients with heart failure with reduced ejection fraction: A patient level meta-analysis of randomized controlled trials.,"BACKGROUND


HFrEF remains associated with high morbidity and mortality, poor quality of life (QoL) and significant exercise limitation. Sympatho-vagal imbalance has been shown to predict adverse prognosis and symptoms in HFrEF, yet it has not been specifically targeted by any guideline-recommended device therapy to date. Barostim™, which directly addresses this imbalance, is the first FDA approved neuromodulation technology for HFrEF.
PURPOSE


Analysis of all randomized trial evidence to evaluate the effect of baroreflex activation therapy (BAT) on HF symptoms, QoL and NT-proBNP in HFrEF.
METHODS AND RESULTS


An individual patient data (IPD) meta-analysis was performed on all eligible trials that randomised HFrEF patients to BAT+GDMT or GDMT alone (open label). Endpoints included 6-month changes in six minute hall walk (6MHW) distance, MLWHF QoL score, NT-proBNP, and NYHA class in all patients, in and three subgroups. 554 randomized patients were included. In all patients, BAT provided significant improvement in 6MHW distance of 49 m (95% C.I. 33, 64), MLWHF QoL of -13 points (95% C.I. -17, -10), and 3.4 higher odds of improving at least one NYHA class (95% C.I. 2.3, 4.9) when comparing from baseline to six months. These improvements were similar, or better, in patients who had baseline NT-proBNP <1600 pg/mL, regardless of the CRT indication status.
CONCLUSION


An IPD meta-analysis suggests that BAT improves exercise capacity and QoL in HFrEF patients receiving GDMT. This clinically meaningful improvement, was consistent across trials and in three investigated patient cohorts and was associated with reduced NT-proBNP in subjects with a lower baseline NT-proBNP.",2022,"This clinically meaningful improvement, was consistent across trials and in three investigated patient cohorts and was associated with reduced NT-proBNP in subjects with a lower baseline NT-proBNP.","['554 randomized patients were included', 'HFrEF patients receiving GDMT', 'patients with heart failure with reduced ejection fraction']","['baroreflex activation therapy (BAT', 'Baroreflex activation therapy', 'BAT+GDMT or GDMT alone (open label', 'proBNP', 'BAT']","['6MHW distance', 'reduced NT-proBNP', 'exercise capacity and QoL', 'MLWHF QoL of -13 points', '6-month changes in six minute hall walk (6MHW) distance, MLWHF QoL score, NT-proBNP, and NYHA class']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",554.0,0.183083,"This clinically meaningful improvement, was consistent across trials and in three investigated patient cohorts and was associated with reduced NT-proBNP in subjects with a lower baseline NT-proBNP.","[{'ForeName': 'Ajs', 'Initials': 'A', 'LastName': 'Coats', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt Heart and Vascular Institute, Nashville, TN, USA.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Weaver', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Duval', 'Affiliation': 'Cardiovascular Division, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Galle', 'Affiliation': 'CVRx®, Inc., Minneapolis, MN, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Inserm Centre d'Investigation, CHU de Nancy, Institute Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France.""}]",European journal of heart failure,['10.1002/ejhf.2573']
2261,35713873,"Efficacy and Safety of Insulin Glargine 300 U/mL in People with Type 2 Diabetes Uncontrolled on Basal Insulin: The 26-Week Interventional, Single-Arm ARTEMIS-DM Study.","INTRODUCTION


The efficacy and safety of switching to insulin glargine 300 U/mL (Gla-300) in type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin (BI) has been demonstrated in the North American and Western European populations; however, there is limited data from other geographical regions with different ethnicities. The ARTEMIS-DM study aimed to evaluate the efficacy and safety of Gla-300 in people with T2DM uncontrolled on BI from Asia, Latin America and Middle East Africa.
METHODS


The ARTEMIS-DM was a 26-week, prospective, interventional, single-arm, phase IV study (NCT03760991). Adults with T2DM previously uncontrolled (glycated haemoglobin [HbA 1c ] 7.5-10%) on BI were switched to Gla-300. The primary endpoint was change in HbA 1c  from baseline to 26 weeks. Key secondary endpoints were changes in HbA 1c  (week 12), fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG) and BI dose from baseline to week 26. The safety and tolerability of Gla-300 were also assessed.
RESULTS


A total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbA 1c  8.67 (0.77)% (71.22 [8.44] mmol/mol). A total of 222 (59.7%) participants were using insulin glargine 100 U/mL and 107 (28.8%) were using neutral protamine Hagedorn insulin as previous BI. There were clinically significant reductions in mean HbA 1c  (- 0.82%; primary endpoint), FPG and SMPG levels at week 26. With a pre-defined titration algorithm, mean Gla-300 dose increased from 27.48 U (0.35 U/kg) at baseline to 39.01 U (0.50 U/kg) at week 26. Hypoglycaemia events occurred in 20.4% of the participants; 1 (0.3%) participant had a severe hypoglycaemia event.
CONCLUSION


In people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration guided by an algorithm was associated with improved glycaemic control and low incidence of hypoglycaemia across multiple geographic regions.
CLINICALTRIALS



GOV IDENTIFIER


NCT03760991.",2022,"There were clinically significant reductions in mean HbA 1c  (- 0.82%; primary endpoint), FPG and SMPG levels at week 26.","['A total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbA 1c  8.67 (0.77)% (71.22 [8.44] mmol/mol', '2 diabetes mellitus (T2DM) uncontrolled on basal insulin (BI', '2 Diabetes Uncontrolled on Basal Insulin', 'people with T2DM uncontrolled on BI from Asia, Latin America and Middle East Africa', 'A total of 222 (59.7%) participants were using', 'People with Type', 'Adults with T2DM previously uncontrolled (glycated haemoglobin [HbA 1c ] 7.5-10%) on BI were switched to Gla-300']","['insulin glargine 300', 'insulin glargine', 'Insulin Glargine 300', 'Gla-300']","['safety and tolerability of Gla-300', 'Hypoglycaemia events', 'FPG and SMPG levels', 'mean HbA 1c', 'efficacy and safety', 'severe hypoglycaemia event', 'Efficacy and Safety', 'changes in HbA 1c  (week\xa012), fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG) and BI dose', 'change in HbA 1c']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.243585,"There were clinically significant reductions in mean HbA 1c  (- 0.82%; primary endpoint), FPG and SMPG levels at week 26.","[{'ForeName': 'Bipin', 'Initials': 'B', 'LastName': 'Sethi', 'Affiliation': 'Care Hospital, Hyderabad, 500034, India. sethibipin54@gmail.com.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Al-Rubeaan', 'Affiliation': 'Research and Scientific Center Sultan Bin Abdulaziz Humanitarian City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Unubol', 'Affiliation': 'Faculty of Medicine, Aydın Adnan Menderes University, Aydın, Turkey.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Mabunay', 'Affiliation': ', Sanofi, Singapore.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Berthou', 'Affiliation': 'IT&M Stats for Sanofi, Paris, France.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Pilorget', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Shireene R', 'Initials': 'SR', 'LastName': 'Vethakkan', 'Affiliation': 'University Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Frechtel', 'Affiliation': 'Hospital de Clínicas, Universidad de Buenos Aires, Buenos Aires, Argentina.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-022-01271-7']
2262,35713846,"Effects of combined physical exercise on plasma lipid variables, paraoxonase 1 activity, and inflammation parameters in adults with obesity: a randomized clinical trial.","OBJECTIVE


We aimed to investigate whether combined physical exercise may affect plasma lipid variables, paraoxonase 1 (PON1) activity, and inflammation parameters in adults with obesity.
METHODS


Thirty-six participants were recruited to complete the study protocol. The mean age was 37 ± 1 years, and the baseline body mass index was 33.0 ± 0.4 kg/m 2 . Participants were allocated to the control group (CG) and the exercise group (EG). The EG performed three weekly sessions of combined physical exercise for 16 weeks. Plasma lipid variables, PON1 activity, and inflammatory profile were determined before and after intervention.
RESULTS


Total cholesterol levels decreased in both groups, without intergroup difference (time p = 0.001). Non-high-density lipoprotein cholesterol (HDL-C) levels decreased in both groups (time p = 0.001); however, they were lower in the EG than in the CG (p = 0.038). The EG had increased HDL-C levels, but the CG had decreased HDL-C levels (time*group p = 0.011). PON1 activity was reduced in both groups (time, p = 0.001). The Castelli risk Index I and II reduced in the EG and increased in the CG (time*group, p = 0.008 and p = 0.011, respectively). The inflammatory markers were not modified.
CONCLUSION


Adults with obesity may benefit from regular practice of combined physical exercise training in many metabolic aspects that are related to protection against the development of cardiovascular disease.",2022,"Non-high-density lipoprotein cholesterol (HDL-C) levels decreased in both groups (time p = 0.001); however, they were lower in the EG than in the CG (p = 0.038).","['The mean age was 37\u2009±\u20091\xa0years, and the baseline body mass index was 33.0\u2009±\u20090.4\xa0kg/m 2 ', 'Thirty-six participants were recruited to complete the study protocol', 'Adults with obesity', 'adults with obesity']","['combined physical exercise training', 'combined physical exercise', 'control group (CG) and the exercise group (EG']","['plasma lipid variables, paraoxonase 1 activity, and inflammation parameters', 'PON1 activity', 'Plasma lipid variables, PON1 activity, and inflammatory profile', 'Castelli risk Index I and II reduced in the EG', 'Total cholesterol levels', 'plasma lipid variables, paraoxonase 1 (PON1) activity, and inflammation parameters', 'HDL-C levels', 'density lipoprotein cholesterol (HDL-C) levels']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",36.0,0.0386804,"Non-high-density lipoprotein cholesterol (HDL-C) levels decreased in both groups (time p = 0.001); however, they were lower in the EG than in the CG (p = 0.038).","[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Streb', 'Affiliation': 'Grupo de Estudo e Pesquisa em Exercício Físico e Doenças Crônicas Não Transmissíveis, Centro de Desportos-CDS, Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, 88040-900, Brazil. anne.streb@posgrad.ufsc.br.'}, {'ForeName': 'P G S', 'Initials': 'PGS', 'LastName': 'Braga', 'Affiliation': 'Laboratório de Metabolismo e Lípides, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'de Melo', 'Affiliation': 'Departamento de Análises Clínicas, Centro de Ciências da Saúde-CCS, Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, 88040-900, Brazil.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Botelho', 'Affiliation': 'Departamento de Saúde Pública, Centro de Ciências da Saúde-CCS, Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, 88040-900, Brazil.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Maranhão', 'Affiliation': 'Laboratório de Metabolismo e Lípides, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, 05403-000, Brazil.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Del Duca', 'Affiliation': 'Grupo de Estudo e Pesquisa em Exercício Físico e Doenças Crônicas Não Transmissíveis, Centro de Desportos-CDS, Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, 88040-900, Brazil.'}]",Journal of endocrinological investigation,['10.1007/s40618-022-01833-3']
2263,35713803,"Ugly food, not eat: the eating intention of emotional eater for different esthetic food.","BACKGROUND


Emotional eaters eat to relieve their emotions. However, food also contains esthetic information. People generally perceive ugly food as unhealthy and unpalatable. Does the esthetic information of food influence an emotional eater's desire for food in a negative emotional state? In particular, do they have the same lower eating intentions for low esthetic food as non-emotional eaters?
OBJECTIVE/DESIGN/MEASURES


Based on these questions, the present study examined whether the esthetic value of food influences emotional eaters' desires for food. The experiment used a 2 (eating type: emotional eating vs. non-emotional eating) × 2 (food style: high esthetic vs. low esthetic) mixed experimental design. We measured the emotional and non-emotional eaters' eating intentions for different esthetic foods when experiencing negative emotions.
RESULTS


The results showed that emotional eaters have higher intention to eat high esthetic foods. However, they did not have a high eating intention for all foods, and their eating intention did not differ from that of non-emotional eaters when faced with low esthetic food.
CONCLUSION


In conclusion, food esthetic value can affect individual eating intentions. Even for emotional eaters who are in a negative mood, they also did not have a higher eating intention for low esthetic food compared with no-emotional eater.
LEVEL OF EVIDENCE


Level II: controlled trial without randomization.",2022,"Even for emotional eaters who are in a negative mood, they also did not have a higher eating intention for low esthetic food compared with no-emotional eater.
",[],['2 (eating type: emotional eating vs. non-emotional eating)\u2009×\u20092 (food style: high esthetic vs. low esthetic) mixed experimental design'],"['individual eating intentions', ""emotional and non-emotional eaters' eating intentions""]",[],"[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",,0.165576,"Even for emotional eaters who are in a negative mood, they also did not have a higher eating intention for low esthetic food compared with no-emotional eater.
","[{'ForeName': 'Chenjing', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, Guangzhou, 510631, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, Guangzhou, 510631, China.'}, {'ForeName': 'Kaili', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, Guangzhou, 510631, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, Guangzhou, 510631, China.'}, {'ForeName': 'Chuangbing', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, Guangzhou, 510631, China.'}, {'ForeName': 'Siyue', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, Guangzhou, 510631, China.'}, {'ForeName': 'Fuqun', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, Guangzhou, 510631, China.'}, {'ForeName': 'Xianyou', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, Guangzhou, 510631, China. xianyouhe@163.com.'}]",Eating and weight disorders : EWD,['10.1007/s40519-022-01418-2']
2264,35713760,Efficacy and Safety of Lasmiditan as a Novel Acute Treatment in Chinese Patients with Migraine: A Subpopulation Analysis of the Randomized Controlled Phase 3 CENTURION Trial.,"INTRODUCTION


Over the last two decades, there has been no novel acute treatment for migraine to address the large unmet medical need in Chinese patients. Lasmiditan, a novel selective serotonin 1F receptor agonist (ditan), is anticipated to bring clinical benefit in Chinese patients with migraine. The CENTURION study is a multi-country, placebo-controlled phase 3 study designed to assess the first attack efficacy and the consistency of response of lasmiditan in acute treatment of migraine. This subpopulation analysis pooled Chinese patients' data from the primary cohort and additional extended enrollment cohort which was not published previously. This is the first analysis focusing on lasmiditan's efficacy and safety in Chinese patients with migraine and aims to provide relevant evidence for Chinese physicians.
METHODS


Patients were randomized 1:1:1 to one of the three treatment groups for four attacks: (a) lasmiditan 100 mg; (b) lasmiditan 200 mg; or (c) control group. Primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in at least two out of three attacks. Secondary endpoints included pain relief, sustained pain freedom, and disability freedom.
RESULTS


In total, 281 Chinese patients (lasmiditan 100 mg, 95; lasmiditan 200 mg, 92; control, 94) were treated for at least one migraine attack. Both doses of lasmiditan showed improvement versus placebo for pain freedom at 2 h after first attack, with lasmiditan 200 mg showing nominal significance. An early onset of effect was observed with lasmiditan versus placebo. Both doses of lasmiditan showed better results for all key secondary endpoints versus placebo. The most commonly reported treatment-emergent adverse event across all groups was dizziness.
CONCLUSION


In the Chinese population, lasmiditan was better than placebo for both primary endpoints and key secondary endpoints with an acceptable safety profile. No new safety signals were detected in the Chinese population. These findings are generally consistent with those observed in the CENTURION study published data and the established product profile.
TRIAL REGISTRATION NUMBER


NCT03670810.",2022,"Both doses of lasmiditan showed improvement versus placebo for pain freedom at 2 h after first attack, with lasmiditan 200 mg showing nominal significance.","['281 Chinese patients (lasmiditan 100\xa0mg, 95; lasmiditan 200\xa0mg, 92; control, 94) were treated for at least one migraine attack', 'Patients', 'Chinese patients with migraine', 'Chinese patients', 'Chinese Patients with Migraine', 'acute treatment of migraine']","['lasmiditan 100\xa0mg; (b) lasmiditan 200\xa0mg; or (c) control group', 'placebo', 'Lasmiditan']","['pain freedom at 2\xa0h (first attack) and pain freedom', 'pain freedom', 'Efficacy and Safety', 'pain relief, sustained pain freedom, and disability freedom']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",281.0,0.25894,"Both doses of lasmiditan showed improvement versus placebo for pain freedom at 2 h after first attack, with lasmiditan 200 mg showing nominal significance.","[{'ForeName': 'Tingmin', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Second Hospital, Jilin University, Changchun, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Neurology, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaosu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Guogang', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': ""Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Hebo', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Hebei General Hospital, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Hongru', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'LCDDMAC, Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'LCDDMAC, Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Shengyuan', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China. yusy1963@126.com.'}]",Neurology and therapy,['10.1007/s40120-022-00369-1']
2265,35713739,"Adolescent Substance Use Behavior Change Through School Intervention Is Improved by Teacher and School Implementation Support Together, Especially for Girls.","An earlier trial of a school-based, preventative intervention, HealthWise South Africa, demonstrated some efficacy in preventing adolescent drinking and smoking in the Western Cape, South Africa. This was followed by the current implementation trial, which examined how implementation support conditions influenced adolescent drinking and smoking behavior change in the HealthWise intervention. The hybridized implementation-effectiveness trial included 34 schools (n = 2175 students) that provided student data at four waves through Grades 8 to 10. Implementation support conditions included a combination of two components (enhanced school environment and teacher consultation), resulting in four conditions: enhanced school environment, teacher consultation, both components, and standard delivery. Using configural frequency analysis, we examined how drinking and smoking behavior change differed across four configurations of intervention support longitudinally and by gender. For baseline non-smokers, results indicated sustained differences in abstention from smoking and smoking initiation between schools that received both support components and schools in the standard delivery condition. These results were primarily driven by girls. For baseline drinkers and smokers in the both components condition, changes in drinking were delayed until Grade 9 and smoking decayed by Grade 10. Results suggest that providing both school and teacher implementation support synergistically facilitates improved intervention outcomes both immediately following intervention and 2 years later across schools with diverse resource levels. Future iterations of HealthWise, and other interventions, may benefit from a multilevel implementation support strategy to improve student outcomes. More research is needed to understand how to improve HealthWise effectiveness among boys.",2022,"For baseline non-smokers, results indicated sustained differences in abstention from smoking and smoking initiation between schools that received both support components and schools in the standard delivery condition.",['34 schools (n\u2009=\u20092175 students) that provided student data at four waves through Grades 8 to 10'],['School Intervention'],"['HealthWise effectiveness', 'adolescent drinking and smoking behavior change']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0684314', 'cui_str': 'Adolescent Alcohol Consumption'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",34.0,0.0325174,"For baseline non-smokers, results indicated sustained differences in abstention from smoking and smoking initiation between schools that received both support components and schools in the standard delivery condition.","[{'ForeName': 'Eric K', 'Initials': 'EK', 'LastName': 'Layland', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA. eric.layland@yale.edu.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Caldwell', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Nilam', 'Initials': 'N', 'LastName': 'Ram', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Smith', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wegner', 'Affiliation': 'University of Western Cape, Cape Town, WC, South Africa.'}, {'ForeName': 'Joachim J', 'Initials': 'JJ', 'LastName': 'Jacobs', 'Affiliation': 'University of Western Cape, Cape Town, WC, South Africa.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-022-01394-0']
2266,35714163,Lacticaseibacillus rhamnosus  HA-114 improves eating behaviors and mood-related factors in adults with overweight during weight loss: a randomized controlled trial.,"Background:  Gut microbiota has emerged as a modifiable factor influencing obesity and metabolic diseases. Interventions targeting this microbial community could attenuate biological and psychological comorbidities of excess weight.  Objective:  Our aim was to determine if  Lacticaseibacillus rhamnosus  HA-114 supplementation accentuated beneficial impact of weight loss on metabolic and cognitive health.  Methods:  This 12-week randomized, double-blind, placebo-controlled trial assessed biological markers of energy metabolism, eating behaviors and mood-related factors in 152 adults with overweight receiving  L. rhamnosus  HA-114 supplementation or placebo, that were also on a dietary intervention inducing a controlled weight loss.  Results:  Although probiotic supplementation did not potentiate the reduction in body weight or fat mass, a significant decrease in plasma insulin, HOMA-IR, LDL-cholesterol and triglycerides was observed in the probiotic-supplemented group only. With respect to eating behaviors and mood-related factors, beneficial effects were either observed only in the group receiving probiotic supplementation or were significantly greater in this group, including decrease in binge eating tendencies, disinhibition and food-cravings.  Conclusion:  This study demonstrates the clinical relevance of probiotic supplementation to induce beneficial metabolic and psychological outcomes in individuals with overweight undergoing weight loss. Trial registration:  ClinicalTrials.gov identifier: NCT02962583.",2022,"With respect to eating behaviors and mood-related factors, beneficial effects were either observed only in the group receiving probiotic supplementation or were significantly greater in this group, including decrease in binge eating tendencies, disinhibition and food-cravings.  ","['individuals with overweight undergoing weight loss', '152 adults with overweight receiving  L. rhamnosus  HA-114 supplementation or placebo, that were also on a dietary intervention inducing a controlled weight loss', 'adults with overweight during weight loss']","['Lacticaseibacillus rhamnosus  HA-114', 'probiotic supplementation', 'placebo']","['body weight or fat mass', 'plasma insulin, HOMA-IR, LDL-cholesterol and triglycerides', 'eating behaviors and mood-related factors', 'binge eating tendencies, disinhibition and food-cravings']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}]","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}]",152.0,0.20666,"With respect to eating behaviors and mood-related factors, beneficial effects were either observed only in the group receiving probiotic supplementation or were significantly greater in this group, including decrease in binge eating tendencies, disinhibition and food-cravings.  ","[{'ForeName': 'Béatrice S-Y', 'Initials': 'BS', 'LastName': 'Choi', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Québec, Canada.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Brunelle', 'Affiliation': 'Department of Kinesiology, Laval University, Québec, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Pilon', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Québec, Canada.'}, {'ForeName': 'Brunella Gonzalez', 'Initials': 'BG', 'LastName': 'Cautela', 'Affiliation': 'Rosell Institute for Microbiome and Probiotics, Montréal, Canada.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Tompkins', 'Affiliation': 'Rosell Institute for Microbiome and Probiotics, Montréal, Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Drapeau', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Québec, Canada.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Marette', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Québec, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Québec, Canada.'}]",Nutritional neuroscience,['10.1080/1028415X.2022.2081288']
2267,35714121,Heart Rehabilitation for All (HeRTA): Protocol for a feasibility study and pilot randomized trial.,"INTRODUCTION


Today, 50% of people with cardiac disease do not participate in rehabilitation. The HeRTA-study aims to develop and test a sustainable rehabilitation model supporting vulnerable patients in participating in rehabilitation and long-term physical activity.
METHODS


A feasibility study with a non-blinded pilot randomized trial was developed in collaboration with partners and cardiac patients to test a multi-component rehabilitation intervention across hospital, municipality, and civil society. The study runs from January 2020 to December 2024. Eligibility criteria for participants: a) diagnosed with either ischemic heart disease, persistent atrial fibrillation, heart failure, or have had cardiac valve surgery, b) residents in Hvidovre Hospitals uptake area, c) cognitively functional, d) physically able to participate in rehabilitation. Patient recruitment will be located at Hvidovre Hospital, Capital Region of Denmark, data collection at Hvidovre Hospital, Rehabilitation Center Albertslund, the Danish Heart Association, and in two municipalities (Hvidovre and Brøndby). Patients in the control group have access to usual care at the hospital: rehabilitation-needs-assessment, patient education, and physical training. After or instead of hospital rehabilitation, the patient can be referred to municipal rehabilitation with patient education, and a total of 12 weeks of physical training across sectors. Patients in the intervention group will in addition to usual care, have access to an information book about cardiac disease, patient supporters from the Danish Heart Association, Information materials to inform employers about the employees' rehabilitation participation, a rehabilitation goal setting plan, a support café for relatives, and follow-up phone calls from physiotherapists 1 and 3 months after rehabilitation to support physical activities. Patients with vulnerabilities will additionally receive patient education conducted in small groups, pro-active counselling by a cardiac nurse, psychologist, or social worker, paid transportation to rehabilitation, and paid membership in a sports association. Patients are computer block-randomized so patients with vulnerability are distributed evenly in the two study arms by stratifying on a) a cut-off score of ≥ 5 in the Tilburg Frailty Indicator questionnaire and/or b) need of language translator support. A power calculation, based on an estimated 20% difference in participation proportion between groups, 80% power, a type 1 error of 5% (two-tailed), results in 91 participants in each study arm. The primary outcome: rehabilitation participation (attending ≥ two activities: patient education, smoking cessation, dietary counseling, and physical training) and reaching at least 50% attendance. Secondary outcomes: health-related quality of life, coping strategies, level of physical activities, and sustainability regarding participation in active communities after rehabilitation. The study is registered at ClinicalTrials.gov (NCT05104658).
RESULTS


Differences between changes in outcomes between groups will be analyzed according to the intention-to-treat principle. Sensitivity analysis and analysis of the effect of the combined activities will be made. A process evaluation will clarify the implementation of the model, the partnership, and patients' experiences.
CONCLUSION


Cross-sectoral collaborations between hospitals, municipalities, and organizations in civil society may lead to sustainable and affordable long-term physical activities for persons with chronic illness. The results can lead to improve cross-sectoral collaborations in other locations and patient groups.",2022,"Patients in the intervention group will in addition to usual care, have access to an information book about cardiac disease, patient supporters from the Danish Heart Association, Information materials to inform employers about the employees' rehabilitation participation, a rehabilitation goal setting plan, a support café for relatives, and follow-up phone calls from physiotherapists 1 and 3 months after rehabilitation to support physical activities.","['Eligibility criteria for participants: a) diagnosed with either ischemic heart disease, persistent atrial fibrillation, heart failure, or have had cardiac valve surgery, b) residents in Hvidovre Hospitals uptake area, c', 'The study runs from January 2020 to December 2024', 'Patients with vulnerabilities', 'persons with chronic illness', 'vulnerable patients in participating in rehabilitation and long-term physical activity', 'collaboration with partners and cardiac patients to test a multi-component rehabilitation intervention across hospital, municipality, and civil society']","['pro-active counselling by a cardiac nurse, psychologist, or social worker, paid transportation to rehabilitation, and paid membership in a sports association', 'usual care at the hospital: rehabilitation-needs-assessment, patient education, and physical training']","['health-related quality of life, coping strategies, level of physical activities, and sustainability regarding participation in active communities after rehabilitation', 'rehabilitation participation (attending ≥ two activities: patient education, smoking cessation, dietary counseling, and physical training) and reaching at least 50% attendance']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3887625', 'cui_str': 'Coronary care nurse'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0558005', 'cui_str': 'Assessment of needs'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2004436', 'cui_str': 'Activity therapy'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0247777,"Patients in the intervention group will in addition to usual care, have access to an information book about cardiac disease, patient supporters from the Danish Heart Association, Information materials to inform employers about the employees' rehabilitation participation, a rehabilitation goal setting plan, a support café for relatives, and follow-up phone calls from physiotherapists 1 and 3 months after rehabilitation to support physical activities.","[{'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Birke', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Foxvig', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Burns', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Toft', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'Anders Blædel Gottlieb', 'Initials': 'ABG', 'LastName': 'Hansen', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'Pernille Ibsen', 'Initials': 'PI', 'LastName': 'Hauge', 'Affiliation': 'The Danish Heart Association, Copenhagen, Denmark.'}, {'ForeName': 'Sussie', 'Initials': 'S', 'LastName': 'Foghmar', 'Affiliation': 'Cardiology Department, University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Rikke Bülow', 'Initials': 'RB', 'LastName': 'Mindegaard', 'Affiliation': 'Rehabilitation Center, Albertslund Municipality, Albertslund, Denmark.'}, {'ForeName': 'Louise Meinertz', 'Initials': 'LM', 'LastName': 'Jakobsen', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Frederiksberg, Denmark.'}]",PloS one,['10.1371/journal.pone.0270159']
2268,35714108,The flipped classroom is effective for medical students to improve deep tendon reflex examination skills: A mixed-method study.,"Deep tendon reflexes (DTR) are a prerequisite skill in clinical clerkships. However, many medical students are not confident in their technique and need to be effectively trained. We evaluated the effectiveness of a flipped classroom for teaching DTR skills. We recruited 83 fifth-year medical students who participated in a clinical clerkship at the Department of General Medicine, Chiba University Hospital, from November 2018 to July 2019. They were allocated to the flipped classroom technique (intervention group, n = 39) or the traditional technique instruction group (control group, n = 44). Before procedural teaching, while the intervention group learned about DTR by e-learning, the control group did so face-to-face. A 5-point Likert scale was used to evaluate self-confidence in DTR examination before and after the procedural teaching (1 = no confidence, 5 = confidence). We evaluated the mastery of techniques after procedural teaching using the Direct Observation of Procedural Skills (DOPS). Unpaired t-test was used to analyze the difference between the two groups on the 5-point Likert scale and DOPS. We assessed self-confidence in DTR examination before and after procedural teaching using a free description questionnaire in the two groups. Additionally, in the intervention group, focus group interviews (FGI) (7 groups, n = 39) were conducted to assess the effectiveness of the flipped classroom after procedural teaching. Pre-test self-confidence in the DTR examination was significantly higher in the intervention group than in the control group (2.8 vs. 2.3, P = 0.005). Post-test self-confidence in the DTR examination was not significantly different between the two groups (3.9 vs. 4.1, P = 0.31), and so was mastery (4.3 vs. 4.1, P = 0.68). The questionnaires before the procedural teaching revealed themes common to the two groups, including ""lack of knowledge"" and ""lack of self-confidence."" Themes about prior learning, including ""acquisition of knowledge"" and ""promoting understanding,"" were specific in the intervention group. The FGI revealed themes including ""application of knowledge,"" ""improvement in DTR technique,"" and ""increased self-confidence."" Based on these results, teaching DTR skills to medical students in flipped classrooms improves readiness for learning and increases self-confidence in performing the procedure at a point before procedural teaching.",2022,"Pre-test self-confidence in the DTR examination was significantly higher in the intervention group than in the control group (2.8 vs. 2.3, P = 0.005).","['83 fifth-year medical students who participated in a clinical clerkship at the Department of General Medicine, Chiba University Hospital, from November 2018 to July 2019']","['flipped classroom technique (intervention group, n = 39) or the traditional technique instruction', 'Deep tendon reflexes (DTR']","['lack of knowledge"" and ""lack of self-confidence', 'self-confidence in DTR examination', 'application of knowledge,"" ""improvement in DTR technique,"" and ""increased self-confidence', 'Pre-test self-confidence in the DTR examination', 'readiness for learning and increases self-confidence', '5-point Likert scale and DOPS', 'deep tendon reflex examination skills', 'DTR examination']","[{'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0008955', 'cui_str': 'Clerkships, Clinical'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0034943', 'cui_str': 'Peripheral reflex'}]","[{'cui': 'C1998986', 'cui_str': 'Deficient knowledge'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0034943', 'cui_str': 'Peripheral reflex'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",39.0,0.0149471,"Pre-test self-confidence in the DTR examination was significantly higher in the intervention group than in the control group (2.8 vs. 2.3, P = 0.005).","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Uchida', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Shikino', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Ishizuka', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Yamauchi', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Yanagita', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Yokokawa', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Noda', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Uehara', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Masatomi', 'Initials': 'M', 'LastName': 'Ikusaka', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, Chiba, Japan.'}]",PloS one,['10.1371/journal.pone.0270136']
2269,35714103,Practical and Emotional Peer Support Tailored for Life's Challenges: Personalized Support for Progress Randomized Clinical Pilot Trial in a Veterans Health Administration Women's Clinic.,"INTRODUCTION


Women Veterans experience a broad range of stressors (e.g., family, relationship, and financial) and high rates of mental health and physical health conditions, all of which contribute to high levels of stress. Personalized Support for Progress (PSP), an evidence-based intervention, is well suited to support women Veterans with high stress as it involves a card-sort task to prioritize concerns as well as pragmatic and emotional support to develop and implement a personalized plan addressing those concerns. Our aims were to explore the population and context for delivery and evaluate the feasibility, acceptability, and utility of PSP delivered by a peer specialist to complement existing services in a Veterans Health Administration (VHA) Women's Wellness Center.
MATERIALS AND METHODS


This randomized controlled pilot trial compared treatment as usual plus PSP to treatment as usual and used the a priori Go/No-Go criteria to establish success for each outcome. We interviewed staff regarding the population and delivery context at a VHA Women's Wellness Center and analyzed interviews using a rapid qualitative approach. For the rapid qualitative analysis, we created templated summaries of each interview to identify key concepts within each a priori theme, reviewed each theme's content across all interviews, and finally reviewed key concepts across themes. We evaluated feasibility using recruitment and retention rates; acceptability via Veteran satisfaction, working relationship with the peer, and staff satisfaction; and utility based on the proportion of Veterans who experienced a large change in outcomes (e.g., stress, mental health symptoms, and quality of life). The Syracuse VA Human Subjects Institutional Review Board approved all procedures.
RESULTS


Staff interviews highlight that women Veterans have numerous unmet social needs and concerns common among women which increase the complexity of their care; call for a supportive, consistent, trusting relationship with someone on their health care team; and require many resources (e.g., staff such as social workers, services such as legal support, and physical items such as diapers) to support their needs (some of which are available within VHA but may need support for staffing or access, and some of which are unavailable). Feasibility outcomes suggest a need to modify PSP and research methods to enhance intervention and assessment retention before the larger trial; the recruitment rate was acceptable by the end of the trial. Veteran acceptability of PSP was high. Veteran outcomes demonstrate promise for utility to improve stress, mental health symptoms, and quality of life for women Veterans.
CONCLUSIONS


Given the high acceptability and promising outcomes for utility, changes to the design to enhance the feasibility outcomes which failed to meet the a priori Go/No-Go criteria are warranted. These outcomes support future trials of PSP within VHA Women's Wellness Centers.",2022,Veteran acceptability of PSP was high.,"[""Life's Challenges"", 'women Veterans with high stress', 'Veterans Health Administration (VHA', 'women Veterans', ""Veterans Health Administration Women's Clinic""]",['usual plus PSP'],"['stress, mental health symptoms, and quality of life']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0821119,Veteran acceptability of PSP was high.,"[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Johnson', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY 13210, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Poleshuck', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY 13210, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Possemato', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY 13210, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Hampton', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY 13210, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Funderburk', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY 13210, USA.'}, {'ForeName': 'Harminder', 'Initials': 'H', 'LastName': 'Grewal', 'Affiliation': ""Women's Wellness Center, Syracuse VA Medical Center, Syracuse, NY 13210, USA.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cerulli', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, NY 14642, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Wittink', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, NY 14642, USA.'}]",Military medicine,['10.1093/milmed/usac164']
2270,35714077,"Cardiovascular, Respiratory, and Functional Effects of Home-based Exercise Training after COVID-19 Hospitalization.","INTRODUCTION/PURPOSE


The present randomized, single-center and single-blinded clinical trial tested the hypothesis that tele-supervised home-based exercise training (exercise) is an effective strategy for improving cardiovascular, respiratory, and functional capacity parameters in individuals that were hospitalized due to coronavirus disease 2019 (COVID-19).
METHODS


Thirty-two individuals (52 ± 10 years; 17F) randomly assigned to exercise (N = 12) and control groups (N = 20), had their anthropometric (weight, body mass index), hemodynamic (brachial and central blood pressure), vascular (arterial stiffness), ventilatory (pulmonary function and respiratory muscle strength), and functional parameters (handgrip strength, five-time sit to stand [FTSTS], timed up and go test [TUG] and six-minute walking test [6MWT]) assessed at baseline (30 to 45 days of hospital discharged) and after 12 weeks of follow-up.
RESULTS


Both groups similarly increased (P < 0.001) forced vital capacity (absolute and % of predicted), forced expiratory volume in the first second (absolute and % of predicted), and handgrip strength during follow-up. However, only exercise group reduced carotid-femoral pulse wave velocity (-2.0 ± 0.6 m/s, P = 0.048), and increased (P < 0.05) resting oxygen saturation (1.9 ± 0.6 %), mean inspiratory pressure (24.7 ± 7.1 cmH2O), mean expiratory pressure (20.3 ± 5.8 cmH2O) and % of predicted mean expiratory pressure (14 ± 22 %) during follow-up. No significant changes were found in any other variable during follow-up.
CONCLUSIONS


Present findings suggest that tele-supervised home-based exercise training can be a potential adjunct therapeutic to rehabilitate individuals that were hospitalized due to COVID-19.",2022,"Both groups similarly increased (P < 0.001) forced vital capacity (absolute and % of predicted), forced expiratory volume in the first second (absolute and % of predicted), and handgrip strength during follow-up.","['Thirty-two individuals (52 ± 10 years; 17F) randomly assigned to exercise (N = 12) and control groups (N = 20), had their', 'individuals that were hospitalized due to coronavirus disease 2019 (COVID-19']","['Home-based Exercise Training', 'tele-supervised home-based exercise training (exercise', 'tele-supervised home-based exercise training']","['mean inspiratory pressure', 'carotid-femoral pulse wave velocity', 'handgrip strength', 'forced expiratory volume', 'vital capacity', 'resting oxygen saturation', 'mean expiratory pressure', 'anthropometric (weight, body mass index), hemodynamic (brachial and central blood pressure), vascular (arterial stiffness), ventilatory (pulmonary function and respiratory muscle strength), and functional parameters (handgrip strength, five-time sit to stand [FTSTS], timed up and go test [TUG] and six-minute walking test [6MWT']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0493163,"Both groups similarly increased (P < 0.001) forced vital capacity (absolute and % of predicted), forced expiratory volume in the first second (absolute and % of predicted), and handgrip strength during follow-up.","[{'ForeName': 'Vanessa Teixeira', 'Initials': 'VT', 'LastName': 'do Amaral', 'Affiliation': 'São Paulo State University (UNESP), School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, BRAZIL.'}, {'ForeName': 'Ariane Aparecida', 'Initials': 'AA', 'LastName': 'Viana', 'Affiliation': 'São Paulo State University (UNESP), School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, BRAZIL.'}, {'ForeName': 'Alessandro Domingues', 'Initials': 'AD', 'LastName': 'Heubel', 'Affiliation': 'Federal University of São Carlos (UFSCar), Department of Physical Therapy, São Carlos, BRAZIL.'}, {'ForeName': 'Stephanie Nogueira', 'Initials': 'SN', 'LastName': 'Linares', 'Affiliation': 'Federal University of São Carlos (UFSCar), Department of Physical Therapy, São Carlos, BRAZIL.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Martinelli', 'Affiliation': 'Sacred Heart University Center (UNISAGRADO), Department of Physical Therapy, Bauru, BRAZIL.'}, {'ForeName': 'Pedro Henrique Camprigher', 'Initials': 'PHC', 'LastName': 'Witzler', 'Affiliation': 'São Paulo State University (UNESP), School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, BRAZIL.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Yudi Orikassa de Oliveira', 'Affiliation': 'São Paulo State University (UNESP), School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, BRAZIL.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'de Souza Zanini', 'Affiliation': 'São Paulo State University (UNESP), School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, BRAZIL.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi Silva', 'Affiliation': 'Federal University of São Carlos (UFSCar), Department of Physical Therapy, São Carlos, BRAZIL.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Federal University of São Carlos (UFSCar), Department of Physical Therapy, São Carlos, BRAZIL.'}, {'ForeName': 'Emmanuel Gomes', 'Initials': 'EG', 'LastName': 'Ciolac', 'Affiliation': 'São Paulo State University (UNESP), School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory (ECDR), Bauru, BRAZIL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002977']
2271,35714076,Breaking Sitting Time with Physical Activity Increases Energy Expenditure but Does Not Alter Postprandial Metabolism in Girls.,"PURPOSE


Young people spend a substantial proportion of their time at school sedentary; therefore, this setting represents an important target for interventions aimed at displacing sedentary time with physical activity. This study aimed to examine the postprandial metabolic effects of breaking sedentary time by accumulating walking and repeated bouts of non-ambulatory standing during simulated school days in inactive adolescent girls.
METHODS


Seventeen girls (12.8 (0.4) years) completed two 3-day experimental conditions. On Day 1 and 2 of the standing + walking (STD-WLK) experimental trial, participants interrupted sedentary time by completing 4 x 10 min bouts of self-paced walking and accumulated 18 x 5 min standing bouts during each simulated school day. On Day 3 of STD-WLK, participants attended school as normal with no additional physical activity or standing prescribed. On all 3 days of the control condition (CON), participants attended school as normal with no physical activity intervention. On Day 2 and 3 of both STD-WLK and CON, a baseline capillary blood sample was provided to determine fasting [TAG] and [glucose]. Participants then consumed a standardised breakfast (0 h) and lunch (4.7 h) and blood samples were provided postprandially at 2.7, 5.3 and 7.3 h for [TAG] and [glucose].
RESULTS


Energy expenditure was 28% (95% CI = 8 to 52%) higher during school hours on Day 1 and Day 2 during STD-WLK compared with CON (2171 vs. 1693 kJ; ES = 0.89, P = 0.008). However, no reduction of fasting or postprandial [TAG] or [glucose] was observed on Day 2 or 3 (P ≥ 0.245).
CONCLUSIONS


Two-consecutive days of breaking prolonged sitting with self-paced walking and intermittent standing had no meaningful effect on postprandial metabolism in adolescent girls.",2022,"RESULTS


Energy expenditure was 28% (95% CI = 8 to 52%) higher during school hours on Day 1 and Day 2 during STD-WLK compared with CON (2171 vs. 1693 kJ; ES = 0.89, P = 0.008).","['Young people spend a substantial proportion of their time at school sedentary', 'Seventeen girls (12.8 (0.4) years) completed two 3-day experimental conditions', 'adolescent girls', 'Girls', 'inactive adolescent girls']","['breaking sedentary time by accumulating walking and repeated bouts of non-ambulatory standing', 'CON']","['Postprandial Metabolism', 'Energy expenditure', 'fasting or postprandial [TAG] or [glucose', 'postprandial metabolism']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",17.0,0.0581429,"RESULTS


Energy expenditure was 28% (95% CI = 8 to 52%) higher during school hours on Day 1 and Day 2 during STD-WLK compared with CON (2171 vs. 1693 kJ; ES = 0.89, P = 0.008).","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Smallcombe', 'Affiliation': ''}, {'ForeName': 'Gregory J H', 'Initials': 'GJH', 'LastName': 'Biddle', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UNITED KINGDOM.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Slater', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UNITED KINGDOM.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': ''}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Barrett', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UNITED KINGDOM.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tolfrey', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002979']
2272,35714057,"Preliminary Outcomes from a Single-Session, Asynchronous Online, Stress and Anxiety Management Workshop for College Students.","OBJECTIVE


Self-guided asynchronous online interventions may provide college students access to evidence-based care, while mitigating barriers like limited hours of service. Thus, we examined the preliminary effectiveness of a 45-minute self-guided, asynchronous online, Dialectical Behavior Therapy (DBT)-informed stress and anxiety management workshop. Participants: College undergraduates (N = 131) were randomized to either workshop (n = 65) or waitlist control (n = 66) conditions.
METHODS


Participants in the workshop condition completed baseline measures of depression, stress, and anxiety, before completing the workshop. Participants in the waitlist control condition only completed the baseline measures. All participants were reassessed at one-week follow-up.
RESULTS


Controlling for baseline measures, students in the workshop condition experienced significantly less stress and greater self-efficacy to regulate stress and anxiety at follow-up, compared to waitlist controls.
CONCLUSIONS


A 45- minute self-guided, asynchronous online, DBT Skills-informed stress and anxiety management workshop may reduce stress and self-efficacy to regulate stress and anxiety.",2022,"RESULTS


Controlling for baseline measures, students in the workshop condition experienced significantly less stress and greater self-efficacy to regulate stress and anxiety at follow-up, compared to waitlist controls.
","['Participants', 'Participants in the workshop condition completed baseline measures of depression, stress, and anxiety, before completing the workshop', 'College undergraduates (N = 131', 'College Students']","['waitlist control', '45-minute self-guided, asynchronous online, Dialectical Behavior Therapy (DBT)-informed stress and anxiety management workshop']","['Asynchronous Online, Stress and Anxiety Management Workshop', 'stress and greater self-efficacy to regulate stress and anxiety']","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",131.0,0.0437727,"RESULTS


Controlling for baseline measures, students in the workshop condition experienced significantly less stress and greater self-efficacy to regulate stress and anxiety at follow-up, compared to waitlist controls.
","[{'ForeName': 'Carol S', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, Nevada State College, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bowman', 'Affiliation': 'Department of Psychology, Nevada State College, USA.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Psychology, University of Massachusetts Boston, USA.'}]",Trends in psychiatry and psychotherapy,['10.47626/2237-6089-2021-0448']
2273,35713974,Short-term and Long-term Outcomes of Laparoscopic Versus Open Selective Lateral Pelvic Lymph Node Dissection for Locally Advanced Middle-low Rectal Cancer: Results of a Multicenter Lateral Node Study in China.,"AIM


Lateral pelvic lymph node dissection (LPND) is a technically challenging procedure, and the safety and feasibility of laparoscopic LPND remains undetermined. We compared the short- and long-term survival outcomes of laparoscopic LPND with those of open LPND.
METHODS


From January 2012 to December 2019, locally advanced middle-low rectal cancer patients with clinical evidence of lateral pelvic lymph node metastasis (LPNM) who underwent total mesorectal excision with LPND at three institutions were included. Propensity score matching was used to minimize selection bias. The short-term and oncological outcomes of open and laparoscopic LPND were compared.
RESULTS


Overall, 384 patients were enrolled, including 277 and 107 patients who underwent laparoscopic and open LPND, respectively. After matching, patients were stratified into laparoscopic (n = 100) and open (n = 100) LPND groups. Patients in the laparoscopic LPND group had a shorter operation time (255 vs. 300 min, P=0.001), less intraoperative blood loss (50 vs. 300 mL, P<0.001), lower incidence of postoperative complications (32.0% vs. 15.0%, P=0.005), shorter postoperative hospital stay (8 vs. 14 days, P<0.001), and excision of more lateral pelvic lymph nodes (9 vs. 7, P=0.025) than those in the open LPND group. The 3-year overall survival (P=0.581) and 3-year disease-free survival (P=0.745) rates were similar between the groups, and LPNM was an independent predictor of survival.
CONCLUSION


Laparoscopic LPND is technically safe and feasible with favourable short-term results and similar oncological outcomes as open surgery in selected patients.",2022,Laparoscopic LPND is technically safe and feasible with favourable short-term results and similar oncological outcomes as open surgery in selected patients.,"['384 patients were enrolled, including 277 and 107 patients who underwent laparoscopic and open LPND, respectively', 'Locally Advanced Middle-low Rectal Cancer', 'From January 2012 to December 2019, locally advanced middle-low rectal cancer patients with clinical evidence of lateral pelvic lymph node metastasis (LPNM) who underwent total mesorectal excision with LPND at three institutions were included']","['laparoscopic LPND', 'Laparoscopic LPND', 'open and laparoscopic LPND', 'Lateral pelvic lymph node dissection (LPND', 'Laparoscopic Versus Open Selective Lateral Pelvic Lymph Node Dissection']","['shorter operation time', '3-year disease-free survival', '3-year overall survival', 'shorter postoperative hospital stay', 'lower incidence of postoperative complications', 'intraoperative blood loss', 'excision of more lateral pelvic lymph nodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node group'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node group'}]",384.0,0.134096,Laparoscopic LPND is technically safe and feasible with favourable short-term results and similar oncological outcomes as open surgery in selected patients.,"[{'ForeName': 'Jianqiang', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Sicheng', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'Department of Colorectal Surgery, Changhai Hospital, Nava Military Medical University, Shanghai, 200433, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Minimally Invasive Surgery Center, Shanghai, 200025, China.'}, {'ForeName': 'Chiying', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing, 100050, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.16223']
2274,35714359,"Infiltration of Bupivacaine and Triamcinolone in Surgical Wounds of Milligan-Morgan Hemorrhoidectomy for Postoperative Pain Control: A Double-Blind, Randomized, Controlled Clinical Trial.","BACKGROUND


Pain management after hemorrhoidectomy continues to be challenging.
OBJECTIVE


The aim of this study was to evaluate the effectiveness of infiltration of bupivacaine and triamcinolone in surgical wounds of Milligan-Morgan hemorrhoidectomy for postoperative pain relief.
DESIGN


A controlled, randomized, double-blind clinical trial was conducted between May 2015 and June 2019.
SETTINGS


This study was carried out in a secondary referral Hospital center in Spain.
PATIENTS


Patients who underwent an elective Milligan-Morgan hemorrhoidectomy for grade III-IV hemorrhoids were included.
INTERVENTIONS


Patients allocated in the intervention group received a single infiltration of bupivacaine and triamcinolone and patients allocated in the control group did not receive any intervention.
MAIN OUTCOMES MEASURES


The primary end point was the median of maximum pain by Visual Analogue Scale during the 48 hours of hospital stay. Secondary end points were pain at follow-up, pain during defecation, analgesic requirements, wound healing rate and complications.
RESULTS


A total of 128 patients were randomly assigned (64 in each group). The median of maximum pain score at 48 hours was 3 points in the intervention group and 6 points in control group with significant differences (p < 0.05). No differences were observed regarding pain during defecation. Morphine requirements were significant lower in the intervention group (6.3% vs 21.9% patients; p = 0.01; 5 vs 23 cumulative doses; p = 0.01). Wound healing and complications rates were similar in both groups.
LIMITATIONS


Use of placebo was not considered in the control group (""intervention group"" vs ""control plain group"" clinical trial). Data regarding pain or other complications after 48 hours post-operative were pooled and expressed as median of values.
CONCLUSIONS


Infiltration of surgical wounds with bupivacaine and triamcinolone decreases postoperative pain and reduces morphine requirements in Milligan-Morgan hemorrhoidectomy. See Video Abstract at http://links.lww.com/DCR/B867.",2021,Morphine requirements were significant lower in the intervention group (6.3% vs 21.9% patients; p = 0.01; 5 vs 23 cumulative doses; p = 0.01).,"['secondary referral Hospital center in Spain', '128 patients', 'Surgical Wounds of Milligan-Morgan Hemorrhoidectomy for Postoperative Pain Control', 'Patients who underwent an elective Milligan-Morgan hemorrhoidectomy for grade III-IV hemorrhoids were included', 'surgical wounds of Milligan-Morgan hemorrhoidectomy for postoperative pain relief', 'Milligan-Morgan hemorrhoidectomy', 'May 2015 and June 2019']","['Bupivacaine and Triamcinolone', 'placebo', 'bupivacaine and triamcinolone', 'control group did not receive any intervention']","['morphine requirements', 'pain during defecation', 'median of maximum pain by Visual Analogue Scale', 'postoperative pain', 'Morphine requirements', 'Wound healing and complications rates', 'pain at follow-up, pain during defecation, analgesic requirements, wound healing rate and complications', 'median of maximum pain score']","[{'cui': 'C3658282', 'cui_str': 'Secondary Referral Center'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0582521', 'cui_str': 'Morgan'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",128.0,0.270765,Morphine requirements were significant lower in the intervention group (6.3% vs 21.9% patients; p = 0.01; 5 vs 23 cumulative doses; p = 0.01).,"[{'ForeName': 'Nolberto A', 'Initials': 'NA', 'LastName': 'Medina-Gallardo', 'Affiliation': 'Department of General Surgery, Vic Hospital Consortium, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'De Castro-Gutierrez', 'Affiliation': 'Department of General Surgery, Vic Hospital Consortium, Spain.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'De Caralt-Mestres', 'Affiliation': 'Department of General Surgery, Vic Hospital Consortium, Spain.'}, {'ForeName': 'Yuhamy', 'Initials': 'Y', 'LastName': 'Curbelo-Pena', 'Affiliation': 'Department of General Surgery, Vic Hospital Consortium, Spain.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Dardano-Berriel', 'Affiliation': 'Department of General Surgery, Vic Hospital Consortium, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Serrat-Puyol', 'Affiliation': 'Department of Anesthesiology, Vic Hospital Consortium, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Roura-Poch', 'Affiliation': 'Department of Epidemiology, Vic Hospital Consortium, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Vallverdu-Cartie', 'Affiliation': 'Department of General Surgery, Vic Hospital Consortium, Spain.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000002250']
2275,35714357,The Preventive Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Delirium in Elderly Patients with Time Factors: A Randomized Trial.,"Objectives:  There is currently no exact and effective treatment for postoperative delirium (POD). The purpose of this study was to observe the effect of transcutaneous electrical acupoint stimulation (TEAS) before surgery and during surgery in elderly patients with POD.  Materials and Methods:  A total of 90 patients were randomly divided into three groups: a preoperative TEAS group (group E1), an intraoperative TEAS group (group E2), and a control group (group C). In group E1, TEAS was applied at the Shenting, Baihui, bilateral Neiguan, and Hegu points for 30 min 1 day before surgery and before the induction of anesthesia. In group E2, TEAS was applied during surgery. In group C, electrodes were applied to the points just cited, but no electric stimulation was administered. The incidence of delirium was assessed within 5 days after surgery, and the plasma concentration of propofol at bispectral index (BIS) = 50 was recorded. Blood samples were collected to measure neuron-specific enolation (NSE), tumor necrosis factor-α (TNF-α), and interleukin (IL)-1β 1 day before surgery and 1 and 5 days after surgery.  Results:  The incidence of delirium in group E1 was decreased in comparison with group C and group E1 (both  p  < 0.05). The propofol plasma concentration at BIS = 50 in group E1 was also decreased in comparison with group C and group E2 (both  p  < 0.05). Compared with group C, the concentrations of NSE, TNF-α, and IL-1β in plasma were decreased in group E1 and group E2 1 and 5 days after surgery (both  p  < 0.05), and the concentrations of NSE and IL-1β in plasma in group E1 were decreased 1 and 5 days after surgery in comparison with group E2.  Conclusion:  The TEAS can reduce the dosage of propofol required during surgery and the occurrence of delirium after surgery. Its mechanism may be related to inhibiting inflammation response and alleviating brain injury. Compared with intraoperative application, the effect of preconditioning with TEAS before surgery is better.  Trial Registration:  ChiCTR-INR-17012501. Date of registration: August 29, 2017.",2022,"Compared with group C, the concentrations of NSE, TNF-α, and IL-1β in plasma were decreased in group E1 and group E2 1 and 5 days after surgery (both  p  < 0.05), and the concentrations of NSE and IL-1β in plasma in group E1 were decreased 1 and 5 days after surgery in comparison with group E2.  ","['A total of 90 patients', 'Elderly Patients with Time Factors', 'elderly patients with POD']","['intraoperative TEAS', 'preoperative TEAS', 'transcutaneous electrical acupoint stimulation (TEAS', 'TEAS', 'Transcutaneous Electrical Acupoint Stimulation']","['neuron-specific enolation (NSE), tumor necrosis factor-α (TNF-α), and interleukin (IL)-1β', 'incidence of delirium', 'concentrations of NSE, TNF-α, and IL-1β in plasma', 'plasma concentration of propofol at bispectral index (BIS', 'Postoperative Delirium', 'propofol plasma concentration', 'concentrations of NSE and IL-1β in plasma']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332311', 'cui_str': 'With time'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0027882', 'cui_str': 'Neuron'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",90.0,0.0223526,"Compared with group C, the concentrations of NSE, TNF-α, and IL-1β in plasma were decreased in group E1 and group E2 1 and 5 days after surgery (both  p  < 0.05), and the concentrations of NSE and IL-1β in plasma in group E1 were decreased 1 and 5 days after surgery in comparison with group E2.  ","[{'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Anesthesiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Ning', 'Affiliation': 'Department of Anesthesiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Shishun', 'Initials': 'S', 'LastName': 'Kou', 'Affiliation': 'Department of Anesthesiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Ke', 'Affiliation': 'Department of Anesthesiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Ruiling', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}]",Journal of integrative and complementary medicine,['10.1089/jicm.2021.0141']
2276,35714315,Time to Cure for Childhood and Young Adult Acute Lymphoblastic Leukemia Is Independent of Early Risk Factors: Long-Term Follow-Up of the UKALL2003 Trial.,"PURPOSE


The aim of the randomized trial, UKALL2003, was to adjust treatment intensity on the basis of minimal residual disease (MRD) stratification for children and young adults with acute lymphoblastic leukemia. We analyzed the 10-year randomized outcomes and the time for patients to be considered cured (ClinicalTrials.gov identifier: NCT00222612).
METHODS


A total of 3,113 patients were analyzed including 1,054 patients who underwent random assignment (521 MRD low-risk and 533 MRD high-risk patients). Time to cure was defined as the point at which the chance of relapse was < 1%. The median follow-up time was 10.98 (interquartile range, 9.19-13.02) years, and survival rates are quoted at 10 years.
RESULTS


In the low-risk group, the event-free survival was 91.7% (95% CI, 87.4 to 94.6) with one course of delayed intensification versus 93.7% (95% CI, 89.9 to 96.1) with two delayed intensifications (adjusted hazard ratio 0.73; 95% CI, 0.38 to 1.40;  P  = .3). In the high-risk group, the event-free survival was 82.1% (95% CI, 76.9 to 86.2) with standard therapy versus 87.1% (95% CI, 82.4 to 90.6) with augmented therapy (adjusted hazard ratio 0.68; 95% CI, 0.44 to 1.06;  P  = .09). Cytogenetic high-risk patients treated on augmented therapy had a lower relapse risk (22.1%; 95% CI, 15.1 to 31.6) versus standard therapy (52.4%; 95% CI, 28.9 to 80.1;  P  = .016). The initial risk of relapse differed significantly by sex, age, MRD, and genetics, but the risk of relapse for all subgroups quickly coalesced at around 6 years after diagnosis.
CONCLUSION


Long-term outcomes of the UKALL2003 trial confirm that low-risk patients can safely de-escalate therapy, while intensified therapy benefits patients with high-risk cytogenetics. Regardless of prognosis, the time to cure is similar across risk groups. This will facilitate communication to patients and families who pose the question ""When am I/is my child cured?""",2022,"Cytogenetic high-risk patients treated on augmented therapy had a lower relapse risk (22.1%; 95% CI, 15.1 to 31.6) versus standard therapy (52.4%; 95% CI, 28.9 to 80.1;  P  = .016).","['3,113 patients were analyzed including 1,054 patients who underwent random assignment (521 MRD low-risk and 533 MRD high-risk patients', 'children and young adults with acute lymphoblastic leukemia', 'patients to be considered cured', 'Childhood and Young Adult Acute']",['UKALL2003'],"['survival rates', 'relapse risk', 'Time to cure', 'initial risk of relapse', 'median follow-up time', 'event-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",3113.0,0.257434,"Cytogenetic high-risk patients treated on augmented therapy had a lower relapse risk (22.1%; 95% CI, 15.1 to 31.6) versus standard therapy (52.4%; 95% CI, 28.9 to 80.1;  P  = .016).","[{'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': 'Moorman', 'Affiliation': 'Leukaemia Research Cytogenetics Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Antony', 'Affiliation': 'Leukaemia Research Cytogenetics Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wade', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ellie R', 'Initials': 'ER', 'LastName': 'Butler', 'Affiliation': 'Leukaemia Research Cytogenetics Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Enshaei', 'Affiliation': 'Leukaemia Research Cytogenetics Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Christine J', 'Initials': 'CJ', 'LastName': 'Harrison', 'Affiliation': 'Leukaemia Research Cytogenetics Group, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Moppett', 'Affiliation': 'Department of Paediatric Oncology, Bristol Royal Hospital for Children, Bristol, United Kingdom.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hough', 'Affiliation': 'Department of Clinical Haematology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Rowntree', 'Affiliation': 'Cardiff and Vale University Health Board (UHB), Wales, United Kingdom.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Hancock', 'Affiliation': 'Bristol Genetics Laboratory, North Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Goulden', 'Affiliation': 'Department of Haematology, Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Samarasinghe', 'Affiliation': 'Department of Haematology, Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Vora', 'Affiliation': 'Department of Haematology, Great Ormond Street Hospital, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.22.00245']
2277,35714312,"Enasidenib vs conventional care in mutant-IDH2 relapsed/refractory acute myeloidleukemia: a randomized, phase 3 trial.","This open-label, randomized, phase 3 trial (NCT02577406) compared enasidenib, an oral IDH2 inhibitor, with conventional care regimens (CCR) in patients aged ≥60 years with late-stage, mutant-IDH2 acute myeloid leukemia (AML) relapsed/refractory (R/R) to 2 or 3 prior AML-directed therapies. Patients were first preselected to a CCR (azacitidine, intermediate-dose cytarabine, low-dose cytarabine, or supportive care), and then randomized (1:1) to enasidenib 100 mg/day or CCR. The primary endpoint was overall survival (OS). Secondary endpoints included event-free survival (EFS), time to treatment failure (TTF), overall response rate (ORR), hematologic improvement (HI), and transfusion independence (TI). Overall, 319 patients were randomized to enasidenib (n=158) or CCR (n=161). Median age was 71 years. Median (range) enasidenib exposure was 142 days (3-1270) and CCR was 36 days (1-1166). One enasidenib (0.6%) and 20 CCR (12%) patients received no randomized treatment, and 30% and 43%, respectively, received subsequent AML-directed therapies during follow-up. Median OS with enasidenib vs CCR was 6.5 vs 6.2 months (HR [hazard ratio] 0.86; P=.23); 1-year survival was 37.5% vs 26.1%. Enasidenib meaningfully improved EFS (median 4.9 months, vs 2.6 months with CCR; HR 0.68; P=.008), TTF (median 4.9 vs 1.9 months, HR 0.53; P<.001), ORR (40.5% vs 9.9%; P<.001), HI (42.4% vs 11.2%), and RBC-TI (31.7% vs 9.3%). Enasidenib safety was consistent with prior reports. The primary study endpoint was not met but OS was confounded by early dropout and subsequent AML-directed therapies. Enasidenib provided meaningful benefits in EFS, TTF, ORR, HI, and RBC-TI in this heavily pretreated older mutant-IDH2 R/R AML population.",2022,"Enasidenib provided meaningful benefits in EFS, TTF, ORR, HI, and RBC-TI in this heavily pretreated older mutant-IDH2 R/R AML population.","['mutant-IDH2 relapsed/refractory acute myeloidleukemia', '319 patients were randomized to enasidenib (n=158) or CCR (n=161', 'patients aged ≥60 years with late-stage, mutant-IDH2 acute myeloid leukemia (AML) relapsed/refractory (R/R) to 2 or 3 prior AML-directed therapies']","['enasidenib 100 mg/day or CCR', 'Enasidenib vs conventional care', 'CCR (azacitidine, intermediate-dose cytarabine, low-dose cytarabine, or supportive care', 'conventional care regimens (CCR']","['overall survival (OS', 'Enasidenib safety', 'event-free survival (EFS), time to treatment failure (TTF), overall response rate (ORR), hematologic improvement (HI), and transfusion independence (TI', 'EFS', '1-year survival', 'EFS, TTF, ORR, HI, and RBC-TI', 'Median OS', 'TTF', 'ORR']","[{'cui': 'C2714104', 'cui_str': 'IDH2, human'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4519428', 'cui_str': 'enasidenib'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4519447', 'cui_str': 'enasidenib 100 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4519428', 'cui_str': 'enasidenib'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4519428', 'cui_str': 'enasidenib'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",319.0,0.143358,"Enasidenib provided meaningful benefits in EFS, TTF, ORR, HI, and RBC-TI in this heavily pretreated older mutant-IDH2 R/R AML population.","[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'de Botton', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Papayannidis', 'Affiliation': 'IRCCS, Azienda Ospedaliero Universitaria di Bologna, Istituto di Ematologia, Bologna, Italy.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Vyas', 'Affiliation': 'University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'The Alfred Hospital, Australia.'}, {'ForeName': 'Hans Beier', 'Initials': 'HB', 'LastName': 'Ommen', 'Affiliation': 'Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Semochkin', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Hee-Je', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ""Catholic Hematology Hospital, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea, Republic of.""}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'University of Chicago, Chicago, Illinois, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Koprivnikar', 'Affiliation': 'John Theurer Cancer Center at Hackensack Meridian Health, Hackensack, New Jersey, United States.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Frankfurt', 'Affiliation': 'Northwestern University, Coral Gables, Florida, United States.'}, {'ForeName': 'Felicitas R', 'Initials': 'FR', 'LastName': 'Thol', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Chromik', 'Affiliation': 'Universitätsklinikum Frankfurt, Goethe Universität, Frankfurt/Main, Germany.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Byrne', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Pigneux', 'Affiliation': 'Hopital haut leveque, Pessac, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Thomas', 'Affiliation': 'LYON-SUD HOSPITAL, Pierre Benite, France.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Salamero', 'Affiliation': ""Hospital Universitari de la Vall d' Hebron, VHIO, Barcelona, Spain.""}, {'ForeName': 'María-Belén', 'Initials': 'MB', 'LastName': 'Vidriales', 'Affiliation': 'University Hospital of Salamanca (HUS/IBSAL), CIBERONC- CB16/12/00233 and Center for Cancer Research-IBMCC (USAL-CSIC), Salamanca, Spain.'}, {'ForeName': 'Vadim A', 'Initials': 'VA', 'LastName': 'Doronin', 'Affiliation': 'City Clinical Hospital #40, Moscow, Russian Federation.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Amir T', 'Initials': 'AT', 'LastName': 'Fathi', 'Affiliation': 'Massachusetts General Hospital / Harvard Medical School, Boston, Massachusetts, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Laille', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, United States.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, United States.'}, {'ForeName': 'Maroof', 'Initials': 'M', 'LastName': 'Hasan', 'Affiliation': 'Bristal Myers Squibb, Princeton, New Jersey, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martín-Regueira', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, United States.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'UT MD Anderson Cancer Center, Houston, Texas, United States.'}]",Blood,['10.1182/blood.2021014901']
2278,35714294,Effects of Psychoeducation on People With Schizophrenia in Long-Term Care: An Intervention Study.,"The aim of the current study was to examine the effect of a psychoeducation intervention on knowledge, insight, and internalized stigma among people with schizophrenia in a long-term care (LTC) facility in Jordan. This study was conducted based on cluster randomization using a pre- and post-test design. The intervention group ( n  = 66) received seven sessions about schizophrenia over a 3-week period along with usual treatment. The control group ( n  = 56) received usual treatment only. The psychoeducation intervention significantly improved knowledge (15.5%) and insight (22.5%) and reduced stigma (18%) among participants in the intervention group compared to the control group (2.6%, 4.7%, and 3.6%, respectively). This study shows the importance of integrating psychoeducation interventions in routine care for people with schizophrenia in LTC. [ Journal of Psychosocial Nursing and Mental Health Services, xx (x), xx-xx.].",2022,"The psychoeducation intervention significantly improved knowledge (15.5%) and insight (22.5%) and reduced stigma (18%) among participants in the intervention group compared to the control group (2.6%, 4.7%, and 3.6%, respectively).","['People With Schizophrenia in Long-Term Care', 'people with schizophrenia in LTC', 'people with schizophrenia in a long-term care (LTC) facility in Jordan']","['seven sessions about schizophrenia', 'psychoeducation interventions', 'Psychoeducation', 'usual treatment only', 'psychoeducation intervention']","['knowledge', 'reduced stigma', 'knowledge, insight, and internalized stigma']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0233820', 'cui_str': 'Insight'}]",,0.0151989,"The psychoeducation intervention significantly improved knowledge (15.5%) and insight (22.5%) and reduced stigma (18%) among participants in the intervention group compared to the control group (2.6%, 4.7%, and 3.6%, respectively).","[{'ForeName': 'Majdi', 'Initials': 'M', 'LastName': 'Alhadidi', 'Affiliation': ''}, {'ForeName': 'Lourance Abdel Razzaq Al', 'Initials': 'LARA', 'LastName': 'Hadid', 'Affiliation': ''}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Danaee', 'Affiliation': ''}, {'ForeName': 'Khatijah Lim', 'Initials': 'KL', 'LastName': 'Abdullah', 'Affiliation': ''}, {'ForeName': 'Tang Li', 'Initials': 'TL', 'LastName': 'Yoong', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20220613-02']
2279,35714276,"Safety and immunogenicity of a quadrivalent, inactivated, split-virion influenza vaccine (IIV4-W) in healthy people aged 3-60 years: a phase III randomized clinical noninferiority trial.","BACKGROUND


A quadrivalent split influenza vaccine IIV4-W against both influenza A and B viruses is urgently needed.
METHODS


To evaluate the safety and immunogenicity of IIV4-W in people aged 3-60 years, 2400 participants recruited in a double-blind phase III trial and were randomly assigned to the IIV4-W, TIV1 and TIV2 groups. The immunogenicity indicators were measured at 28 days postvaccination and for 180 days for safety follow-up.
RESULTS


Adverse events (AEs) occurred in 162 (20.28%), 116 (14.55%) and 123 (15.41%) participants in the IIV4-W, TIV1 and TIV2 groups, respectively. All these AEs were mild and self-limiting, and no serious AEs related to the vaccines were observed. IIV4-W elicited a non-inferior immune response for matched strains (the lower limit of 95% CI for GMT ratio >0.67, for SCR and SPR difference >-10%) and superior immune response for the additional B strains (the lower limit of 95% CI for GMT ratio >1.5, for SCR difference >10%) versus TIVs. The lower limit of the 95% confidence interval of the GMT increase fold, the seroconversion rate and the seroprotection rate exceeded 2.5, 40% and 70% for the four strains in IIV4-W respectively.
CONCLUSIONS


IIV4-W was noninferior to the TIV-matched strains and was superior to the additional B strain. IIV4-W was safe in the participants and elicited high antibody titers.",2022,"IIV4-W elicited a non-inferior immune response for matched strains (the lower limit of 95% CI for GMT ratio >0.67, for SCR and SPR difference >-10%) and superior immune response for the additional B strains (the lower limit of 95% CI for GMT ratio >1.5, for SCR difference >10%) versus TIVs.","['healthy people aged 3-60 years', 'people aged 3-60\u2009years, 2400 participants recruited in a double-blind phase III trial']","['quadrivalent, inactivated, split-virion influenza vaccine (IIV4-W']","['safety and immunogenicity', 'immunogenicity indicators', 'seroconversion rate and the seroprotection rate', 'superior immune response', 'Safety and immunogenicity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}]",2400.0,0.570186,"IIV4-W elicited a non-inferior immune response for matched strains (the lower limit of 95% CI for GMT ratio >0.67, for SCR and SPR difference >-10%) and superior immune response for the additional B strains (the lower limit of 95% CI for GMT ratio >1.5, for SCR difference >10%) versus TIVs.","[{'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Fan', 'Affiliation': 'Shanxi Provincial Centers for Disease Control and Prevention, Taiyuan, Shanxi, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Chaoyang Center for Disease Control and Prevention, Taiyuan, Shanxi, China.'}, {'ForeName': 'Xuanxuan', 'Initials': 'X', 'LastName': 'Nian', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Jiayou', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Xuefen', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Shanxi Provincial Centers for Disease Control and Prevention, Taiyuan, Shanxi, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Qinyuan County Center for Disease Control and Prevention, Taiyuan, Shanxi, China.'}, {'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Qinyuan County Center for Disease Control and Prevention, Taiyuan, Shanxi, China.'}, {'ForeName': 'Xixin', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Jinrong', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Haihe', 'Initials': 'H', 'LastName': 'Bian', 'Affiliation': 'Quwo County Center for Disease Control and Prevention, Taiyuan, Shanxi, China.'}, {'ForeName': 'Nianmin', 'Initials': 'N', 'LastName': 'Shi', 'Affiliation': 'Chaoyang Center for Disease Control and Prevention, Taiyuan, Shanxi, China.'}, {'ForeName': 'Xinguo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shanxi Provincial Centers for Disease Control and Prevention, Taiyuan, Shanxi, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'National Engineering Technology Research Center of Combined Vaccines, Wuhan, Hubei, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2079924']
2280,35714273,Clinical evaluation of the lot-to-lot consistency of an enterovirus 71 vaccine in a commercial-scale phase IV clinical trial.,"OBJECTIVE


To evaluate the immunogenicity, safety and lot-to-lot consistency of an inactivated enterovirus 71 (EV71) vaccine cultured in bioreactors with different specifications after full immunization.
METHODS


A randomized, double-blind trial was performed in 3,000 children aged 6 ~ 35 months with six vaccine batches, which were prepared in 40 L and 150 L bioreactors for three consecutive batches respectively. Children were immunized on day 0 and 28, serum samples were collected on day 0 and 56, and neutralizing antibody titers were determined by the microcytopathic method. Immediate reactions were recorded within 30 min, local and systemic symptoms were recorded within 0 ~ 28 days, and serious adverse events were recorded within 6 months.
RESULTS


After immunization with two doses of the inactivated EV71 vaccine, the neutralizing antibody GMT was 825.52 ± 4.09, and the positive conversion rate was 96.18%, with no significant difference. The 95% CI of the serum neutralizing antibody GMT ratio between the two groups after immunization with the three vaccine batches produced in the 150 L and 40 L bioreactors ranged from .67 ~ 1.5. The overall incidence of adverse reactions, mainly grade 1 reactions, for all 6 batches from 0 to 28 days after vaccination was 49.62%, with no significant difference (p = .8736). The incidence of systemic adverse reactions, primarily fever and diarrhea, was 45.14%; the incidence of local adverse reactions, primarily erythema and tenderness, was 9.43%.
CONCLUSION


The EV71 vaccine was highly immunogenic and safe in children aged 6-35 months, and 6 consecutive batches produced by the two bioreactors with different specifications were consistent.",2022,"The EV71 vaccine was highly immunogenic and safe in children aged 6-35 months, and 6 consecutive batches produced by the two bioreactors with different specifications were consistent.","['3,000 children aged 6\u2009~\u200935\u2009months with six vaccine batches, which were prepared in 40\u2009L and 150\u2009L bioreactors for three consecutive batches respectively']",['EV71 vaccine'],"['positive conversion rate', 'serum neutralizing antibody GMT ratio', 'overall incidence of adverse reactions, mainly grade 1 reactions', 'Immediate reactions', 'serious adverse events', 'incidence of local adverse reactions, primarily erythema and tenderness', 'neutralizing antibody titers', 'incidence of systemic adverse reactions, primarily fever and diarrhea', 'local and systemic symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0376432', 'cui_str': 'Bioreactors'}]","[{'cui': 'C3853962', 'cui_str': 'Enterovirus 71 infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",3000.0,0.343886,"The EV71 vaccine was highly immunogenic and safe in children aged 6-35 months, and 6 consecutive batches produced by the two bioreactors with different specifications were consistent.","[{'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Qunying', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Division of Hepatitis virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Fanyue', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xinguo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Meizhi', 'Initials': 'M', 'LastName': 'Du', 'Affiliation': 'Department of Disease Prevention and Control, Pei County Center for Disease Control and Prevention, Pei County, Jiangsu, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Division of Hepatitis virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'School of Public Health, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Disease Prevention and Control, Pei County Center for Disease Control and Prevention, Pei County, Jiangsu, China.'}, {'ForeName': 'Changfu', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Tingbo', 'Initials': 'T', 'LastName': 'Xie', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Research and Development, National Vaccine & Serum Institute, Beijing, China.'}, {'ForeName': 'Qingliang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Hongqiao', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xiuling', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Research and Development, Shanghai Institute of Biological Products Co., Ltd, Shanghai, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'Department of Research and Development, Wuhan Institute of Biological Products Co., Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, Jiangsu, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2063630']
2281,35714267,Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial.,"BACKGROUND


Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis was previously reported as superior to a sham control procedure at 3 months postprocedure in this randomized controlled trial (RCT). The primary endpoint was responder rate: ≥30% improvement (decrease) in 24-hour reflective total nasal symptom score (rTNSS) from baseline. Here, 12-month outcomes following active treatment are reported.
METHODS


This was a prospective, multicenter, patient-blinded RCT. Patients in the index active treatment arm were unblinded at 3 months and followed through 12 months. At 3 months, eligible sham control arm patients were invited to crossover to active treatment. Eligibility criteria included rTNSS ≥6, with moderate-severe rhinorrhea and mild-severe congestion. The TCRF stylus was applied bilaterally to non-overlapping areas in the region of the PNN.
RESULTS


Patients in the index active treatment arm had a mean baseline rTNSS of 8.3 (95%CI 7.9 to 8.7), n = 77. At 12 months, the responder rate was 80.6% (95%CI 69.1%-89.2%), n = 67. At 12 months, the mean change in rTNSS was -4.8 (95%CI -5.5 to -4.1); p<.001; a 57.8% improvement. The available initial rTNSS-based outcomes in the crossover active treatment arm (n = 27) were following the same course as the index treatment arm. No serious adverse events and 8 adverse events related to the device/procedure were reported in the trial to date.
CONCLUSION


TCRF neurolysis of the PNN area is safe and the symptom burden improvement that was superior to a sham procedure at 3 months was sustained through 12 months. This article is protected by copyright. All rights reserved.",2022,TCRF neurolysis of the PNN area is safe and the symptom burden improvement that was superior to a sham procedure at 3 months was sustained through 12 months.,"['chronic rhinitis', 'Patients in the index active treatment arm had a mean baseline rTNSS of 8.3 (95%CI 7.9 to 8.7), n = 77', 'Eligibility criteria included rTNSS ≥6, with moderate-severe rhinorrhea and mild-severe congestion']","['Temperature-controlled radiofrequency neurolysis', 'Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN']","['responder rate: ≥30% improvement (decrease) in 24-hour reflective total nasal symptom score (rTNSS', 'mean change in rTNSS', 'responder rate']","[{'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0700148', 'cui_str': 'Congestion'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0196878', 'cui_str': 'Neurolysis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",27.0,0.388391,TCRF neurolysis of the PNN area is safe and the symptom burden improvement that was superior to a sham procedure at 3 months was sustained through 12 months.,"[{'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Takashima', 'Affiliation': 'The Department of Otolaryngology - Head & Neck Surgery, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'J Pablo', 'Initials': 'JP', 'LastName': 'Stolovitzky', 'Affiliation': 'The Department of Otolaryngology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Randall A', 'Initials': 'RA', 'LastName': 'Ow', 'Affiliation': 'Sacramento Ear Nose and Throat Medical and Surgical Group, Roseville, CA, USA.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Silvers', 'Affiliation': 'Madison ENT & Facial Plastic Surgery, New York, NY, USA.'}, {'ForeName': 'Nadim B', 'Initials': 'NB', 'LastName': 'Bikhazi', 'Affiliation': 'The Ogden Clinic, Ogden, UT, USA.'}, {'ForeName': 'Curtis D', 'Initials': 'CD', 'LastName': 'Johnson', 'Affiliation': 'ENT and Allergy Associates of Florida, Plantation, FL, USA.'}]",International forum of allergy & rhinology,['10.1002/alr.23047']
2282,35714174,"Low-Dose Morphine Reduces Pain Perception and Blood Pressure, but Not Muscle Sympathetic Outflow, Responses During the Cold Pressor Test.","Our knowledge about how low-dose (analgesic) morphine affects autonomic cardiovascular regulation is primarily limited to animal experiments. Notably, it is unknown if low-dose morphine affects human autonomic cardiovascular responses during painful stimuli in conscious humans. Therefore, we tested the hypothesis that low-dose morphine reduces perceived pain and subsequent sympathetic and cardiovascular responses in humans during an experimental noxious stimulus. Twenty-nine participants (14F/15M; 29±6 y; 26±4 kg•m -2 , mean ± SD) completed this randomized, crossover, placebo-controlled trial during two laboratory visits. During each visit, participants completed a cold pressor test (CPT; hand in ~0.4 °C ice bath for two minutes) before and ~35 minutes after drug/placebo administration (5 mg IV morphine or saline). We compared pain perception (100 mm visual analog scale), muscle sympathetic nerve activity (MSNA; microneurography; 14 paired recordings), and beat-to-beat blood pressure (BP; photoplethysmography) between trials (at both pre- and post-drug/placebo time points) using paired, two-tailed t-tests. Before drug/placebo infusion, perceived pain (p=0.92), Δ MSNA burst frequency (n=14, p=0.21), and Δ mean BP (p=0.39) during the CPT were not different between trials. After the drug/placebo infusion, morphine versus placebo attenuated perceived pain (morphine: 43±20 vs. placebo: 57±24 mm,p<0.001) and Δ mean BP (morphine: 10±7 vs. placebo: 13±8 mmHg,p=0.003), but not Δ MSNA burst frequency (morphine: 10±11 vs. placebo: 13±11 bursts/minute,p=0.12), during the CPT. Reductions in pain perception and Δ mean BP were only weakly related (r=0.34,p=0.07; post-morphine CPT minus post-placebo CPT). These data provide valuable information regarding how low-dose morphine affects autonomic cardiovascular responses during an experimental painful stimulus.",2022,"Before drug/placebo infusion, perceived pain (p=0.92), Δ MSNA burst frequency (n=14, p=0.21), and Δ mean BP (p=0.39) during the CPT were not different between trials.","['conscious humans', 'Twenty-nine participants (14F/15M; 29±6 y; 26±4 kg•m -2 , mean ± SD']","['placebo administration (5 mg IV morphine or saline', 'Low-Dose Morphine', 'low-dose (analgesic) morphine', 'morphine versus placebo', 'cold pressor test (CPT', 'morphine', 'placebo']","['autonomic cardiovascular responses', 'pain', 'mean BP', 'pain perception (100 mm visual analog scale), muscle sympathetic nerve activity (MSNA; microneurography; 14 paired recordings), and beat-to-beat blood pressure (BP; photoplethysmography', 'pain perception and', 'Pain Perception and Blood Pressure', 'perceived pain', 'Δ mean BP', 'pain and subsequent sympathetic and cardiovascular responses']","[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",29.0,0.588992,"Before drug/placebo infusion, perceived pain (p=0.92), Δ MSNA burst frequency (n=14, p=0.21), and Δ mean BP (p=0.39) during the CPT were not different between trials.","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States.'}, {'ForeName': 'Luke N', 'Initials': 'LN', 'LastName': 'Belval', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Cimino Iii', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States.'}, {'ForeName': 'Bonnie D', 'Initials': 'BD', 'LastName': 'Orth', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Hendrix', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Hinojosa-Laborde', 'Affiliation': 'US Army Institute of Surgical Research, JBSA Fort Sam Houston, TX, United States.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas, United States.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00092.2022']
2283,35709465,"Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial.","Clinical trials frequently include multiple end points that mature at different times. The initial report, typically on the based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in  JCO  or elsewhere, for which the primary end point has already been reported. We previously reported significantly improved failure-free survival using gemcitabine plus cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma. Here, we present the final overall survival (OS) analysis. In this multicenter, randomized trial, patients were assigned to be treated with concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy (n = 242). With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9%  v  78.8%, hazard ratio, 0.51 [95% CI 0.34 to 0.78];  P  = .001) and a comparable risk of late toxicities (≥ grade 3, 11.3%  v  11.4%). Notably, the depth of the tumor response to induction chemotherapy correlated significantly and positively with survival (complete response  v  partial response  v  stable/progressive disease, 5-year OS, 100%  v  88.4%  v  61.5%,  P  = .005). Besides, patients with a low pretreatment cell-free Epstein-Barr virus DNA load (< 4,000 copies/mL) might not benefit from induction chemotherapy (5-year OS, 90.6%  v  91.4%,  P  = .77). In conclusion, induction chemotherapy before concurrent chemoradiotherapy improved OS significantly in patients with locally advanced nasopharyngeal carcinoma, without increasing the risk of late toxicities. Tumor response to induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA might be useful to guide individualized treatment.",2022,"With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9%  v  78.8%, hazard ratio, 0.51","['Nasopharyngeal Carcinoma', 'patients with locally advanced nasopharyngeal carcinoma', 'locoregionally advanced nasopharyngeal carcinoma']","['induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA', 'concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy', 'Gemcitabine and Cisplatin Induction Chemotherapy', 'gemcitabine plus cisplatin induction chemotherapy']","['risk of late toxicities', '5-year OS', 'survival (complete response  v  partial response  v  stable/progressive disease, 5-year OS', 'final overall survival (OS) analysis', 'late toxicities', 'failure-free survival']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0369169', 'cui_str': 'Epstein-Barr virus DNA'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0938266,"With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9%  v  78.8%, hazard ratio, 0.51","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Guo-Qing', 'Initials': 'GQ', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Cancer Center, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Kun-Yu', 'Initials': 'KY', 'LastName': 'Yang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': 'Department of Head and Neck Oncology, Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': ""Department of Radiation Oncology, XiJing Hospital of Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Yu-Pei', 'Initials': 'YP', 'LastName': 'Chen', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wei-Han', 'Initials': 'WH', 'LastName': 'Hu', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhi-Bin', 'Initials': 'ZB', 'LastName': 'Cheng', 'Affiliation': 'The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Si-Yang', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': 'Department of Head and Neck Oncology, The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Radiation Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xi-Cheng', 'Initials': 'XC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, Peking University Cancer Hospital, Beijing, China.'}, {'ForeName': 'Jin-Gao', 'Initials': 'JG', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Wen-Fei', 'Initials': 'WF', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Mao', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Guan-Qun', 'Initials': 'GQ', 'LastName': 'Zhou', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Guo-Xian', 'Initials': 'GX', 'LastName': 'Long', 'Affiliation': 'Department of Oncology, Cancer Center, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shao-Qiang', 'Initials': 'SQ', 'LastName': 'Liang', 'Affiliation': ""Department of Radiation Oncology, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jin-Hua', 'Initials': 'JH', 'LastName': 'Long', 'Affiliation': 'Department of Head and Neck Oncology, Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zang', 'Affiliation': ""Department of Radiation Oncology, XiJing Hospital of Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Qiao-Dan', 'Initials': 'QD', 'LastName': 'Liu', 'Affiliation': 'Department of Head and Neck Oncology, The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Radiation Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Qiong-Fei', 'Initials': 'QF', 'LastName': 'Su', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Bao-Min', 'Initials': 'BM', 'LastName': 'Zheng', 'Affiliation': 'Department of Radiation Oncology, Peking University Cancer Hospital, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Radiation Oncology, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Clinical Trials Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hao-Yuan', 'Initials': 'HY', 'LastName': 'Mo', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jia-Wei', 'Initials': 'JW', 'LastName': 'Lv', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Du', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ying-Qin', 'Initials': 'YQ', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Fang-Yun', 'Initials': 'FY', 'LastName': 'Xie', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ling-Long', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': ""Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.22.00327']
2284,35709830,Efficacy of fecal microbiota transplantation for patients with irritable bowel syndrome at three years after transplantation.,"BACKGROUND & AIMS


The long-term efficacy and possible adverse events of fecal microbiota transplantation (FMT) for IBS are unknown. This study performed a 3-year follow-up of the patients in our previous clinical trial to clarify these aspects.
METHODS


This study included 125 patients (104 females, and 21 males): 38 in a placebo group, 42 who received 30 g of donor feces, and 45 who received 60 g of donor feces. Feces was administered to the duodenum. The patients provided a fecal sample and completed five questionnaires at baseline and at 2 and 3 years after FMT. Fecal bacteria and dysbiosis index (DI) were analyzed using 16S rRNA gene PCR DNA amplification/probe hybridization covering the V3-V9 regions.
RESULTS


Response rates were 26.3%, 69.1%, and 77.8% in the placebo, 30-g, and 60-g groups, respectively, at 2 years after FMT, and 27.0%, 64.9%, and 71.8%, respectively, at 3 years after FMT. The response rates were significantly higher in the 30-g and 60-g groups than in the placebo group. Patients in the 30-g and 60-g groups had significantly fewer IBS symptoms and fatigue, and a greater quality of life both at 2 and 3 years after FMT. The DI decreased only in the active treatment groups at 2 and 3 years after FMT. Fluorescent signals of 10 bacteria had significant correlations with IBS symptoms and fatigue after FMT in the 30-g and 60-g groups. No long-term adverse events were recorded.
CONCLUSIONS


FMT performed according to our protocol resulted in high response rates and long-standing effects with only few mild self-limited adverse events.",2022,"Patients in the 30-g and 60-g groups had significantly fewer IBS symptoms and fatigue, and a greater quality of life both at 2 and 3 years after FMT.","['125 patients (104 females, and 21 males): 38 in a placebo group, 42 who received 30 g of donor feces, and 45 who received 60 g of donor feces', 'patients with irritable bowel syndrome at three years after transplantation']","['fecal microbiota transplantation (FMT', 'placebo', 'fecal microbiota transplantation']","['Response rates', 'Fecal bacteria and dysbiosis index (DI', 'quality of life', 'IBS symptoms and fatigue', 'response rates']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",125.0,0.119601,"Patients in the 30-g and 60-g groups had significantly fewer IBS symptoms and fatigue, and a greater quality of life both at 2 and 3 years after FMT.","[{'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El-Salhy', 'Affiliation': 'Department of Medicine, Stord Hospital, Stord, Norway; Department of Clinical Medicine and Department of Gastroenterology, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway. Electronic address: magdy.elsalhy@sklbb.n0.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Winkel', 'Affiliation': 'Department of Medicine, Stord Hospital, Stord, Norway.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Casen', 'Affiliation': 'Genetic Analysis AS, Oslo, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Clinical Medicine and Department of Gastroenterology, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway; National Centre of Ultrasound in Gastroenterology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Odd Helge', 'Initials': 'OH', 'LastName': 'Gilja', 'Affiliation': 'Department of Clinical Medicine and Department of Gastroenterology, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway; National Centre of Ultrasound in Gastroenterology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jan Gunnar', 'Initials': 'JG', 'LastName': 'Hatlebakk', 'Affiliation': 'Department of Clinical Medicine and Department of Gastroenterology, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}]",Gastroenterology,['10.1053/j.gastro.2022.06.020']
2285,35709811,Precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent AS04-adjuvanted HPV vaccine: an analysis of the long-term follow-up study from the randomised Costa Rica HPV Vaccine Trial.,"BACKGROUND


In women vaccinated against human papillomavirus (HPV), reductions in cervical disease and related procedures results in more women having intact transformation zones, potentially increasing the risk of cervical lesions caused by non-vaccine-preventable HPV types, a phenomenon termed clinical unmasking. We aimed to evaluate HPV vaccine efficacy against cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and cervical intraepithelial neoplasia grade 3 or worse (CIN3+) attributed to non-preventable HPV types in the long-term follow-up phase of the Costa Rica HPV Vaccine Trial (CVT).
METHODS


CVT was a randomised, double-blind, community-based trial done in Costa Rica. Eligible participants were women aged 18-25 years who were in general good health. Participants were randomly assigned (1:1) to receive an HPV 16 and 18 AS04-adjuvanted vaccine or control hepatitis A vaccine, using a blocked randomisation method (permuted block sizes of 14, 16, and 18). Vaccines in both groups were administered intramuscularly with 0·5 mL doses at 0, 1, and 6 months. Masking of vaccine allocation was maintained throughout the 4-year randomised trial phase, after which participants in the hepatitis A virus vaccine control group were provided the HPV vaccine and exited the study; a screening-only, unvaccinated control group was enrolled. The unvaccinated control group and HPV vaccine group were followed up for 7 years, during which treatment allocation was not masked. One of the prespecified primary endpoints for the long-term follow-up phase was precancers associated with HPV types not prevented by the vaccine, defined as histologically confirmed incident CIN2+ events or CIN3+ events attributed to any HPV type except HPV 16, 18, 31, 33, and 45. Our primary analytical period was years 7-11. Primary analyses were in all participants with at least one follow-up visit and excluded participants with a previous endpoint (ie, modified intention-to-treat cohort). Safety endpoints have been reported elsewhere. This trial is registered with ClinicalTrials.gov, NCT00128661 and NCT00867464. The randomised, masked trial phase is completed; an unmasked subset of women in the HPV-vaccinated group is under active investigation.
FINDINGS


Between June 28, 2004, and Dec 21, 2005, 7466 participants were enrolled (HPV vaccine group n=3727 and hepatitis A virus vaccine control group n=3739). Between March 30, 2009, and July 5, 2012, 2836 women enrolled in the new unvaccinated control group. The primary analytical cohort (years 7 to 11) included 2767 participants in the HPV vaccine group and 2563 in the unvaccinated group for the CIN2+ events endpoint assessment and 2826 participants in the HPV vaccine group and 2592 in the unvaccinated control group for the CIN3+ events endpoint assessment. Median follow-up during years 7 to 11 for women included for the CIN2+ events analysis was 52·8 months (IQR 44·0 to 60·7) for the HPV vaccine group and 49·8 months (42·0 to 56·9) for the unvaccinated control group. During years 7 to 11, clinical unmasking was observed with a negative vaccine efficacy against CIN2+ events attributed to non-preventable HPV types (-71·2% [95% CI -164·0 to -12·5]), with 9·2 (95% CI 2·1 to 15·6) additional CIN2+ events attributed to non-preventable HPV types per 1000 HPV-vaccinated participants versus HPV-unvaccinated participants. 27·0 (95% CI 14·2 to 39·9) fewer CIN2+ events irrespective of HPV type per 1000 vaccinated participants were observed during 11 years of follow-up. Vaccine efficacy against CIN3+ events attributed to non-preventable HPV types during years 7 to 11 was -135·0% (95% CI -329·8 to -33·5), with 8·3 (3·0 to 12·8) additional CIN3+ events attributed to non-preventable HPV types per 1000 vaccinated participants versus unvaccinated participants.
INTERPRETATION


Higher rates of CIN2+ events and CIN3+ events due to non-preventable HPV types in vaccinated versus unvaccinated participants suggests clinical unmasking could attenuate long-term reductions in high-grade disease following successful implementation of HPV vaccination programmes in screened populations. Importantly, the net benefit of vaccination remains considerable; therefore, HPV vaccination should still be prioritised as primary prevention for cervical cancer.
FUNDING


National Cancer Institute and National Institutes of Health Office of Research on Women's Health.
TRANSLATION


For the Spanish translation of the abstract see Supplementary Materials section.",2022,"additional CIN3+ events attributed to non-preventable HPV types per 1000 vaccinated participants versus unvaccinated participants.
","['27·0', 'Between June 28, 2004, and Dec 21, 2005, 7466 participants were enrolled (HPV vaccine group n=3727 and hepatitis A virus vaccine control group n=3739', 'primary analytical cohort (years 7 to 11) included 2767 participants in the HPV vaccine group and 2563 in the unvaccinated group for the CIN2+ events endpoint assessment and 2826 participants in the HPV vaccine group and 2592 in the unvaccinated control group for the CIN3+ events endpoint assessment', 'Between March 30, 2009, and July 5, 2012, 2836 women enrolled in the new unvaccinated control group', 'Eligible participants were women aged 18-25 years who were in general good health', 'women vaccinated against human papillomavirus (HPV']","['HPV vaccine', 'bivalent AS04-adjuvanted HPV vaccine', 'HPV 16 and 18 AS04-adjuvanted vaccine or control hepatitis A vaccine']","['HPV vaccine efficacy against cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and cervical intraepithelial neoplasia grade 3 or worse (CIN3', 'Precancerous cervical lesions', 'long-term follow-up phase was precancers associated with HPV types not prevented by the vaccine, defined as histologically confirmed incident CIN2+ events or CIN3+ events']","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0795623', 'cui_str': 'Hepatitis A Vaccine, Inactivated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0851140', 'cui_str': 'Carcinoma in situ of uterine cervix'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C1277245', 'cui_str': 'General health good'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0999806', 'cui_str': 'Human papillomavirus, type 16'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0170300', 'cui_str': 'Hepatitis A Vaccine'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0851140', 'cui_str': 'Carcinoma in situ of uterine cervix'}, {'cui': 'C0235656', 'cui_str': 'Lesion of cervix'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",7466.0,0.400723,"additional CIN3+ events attributed to non-preventable HPV types per 1000 vaccinated participants versus unvaccinated participants.
","[{'ForeName': 'Jaimie Z', 'Initials': 'JZ', 'LastName': 'Shing', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. Electronic address: jaimie.shing@nih.gov.'}, {'ForeName': 'Shangying', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA; Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas (ACIB), Fundación INCIENSA, San José, Costa Rica; Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hildesheim', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Porras', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas (ACIB), Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Sampson', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schussler', 'Affiliation': 'Information Management Services, Silver Spring, MD, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Schiller', 'Affiliation': 'Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Lowy', 'Affiliation': 'Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mónica S', 'Initials': 'MS', 'LastName': 'Sierra', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Loretto', 'Initials': 'L', 'LastName': 'Carvajal', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA; Agencia Costarricense de Investigaciones Biomédicas (ACIB), Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Aimée R', 'Initials': 'AR', 'LastName': 'Kreimer', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(22)00291-1']
2286,35709798,"Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial.","BACKGROUND


Chikungunya virus (CHIKV) disease is an ongoing public health threat. We aimed to evaluate the safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted formulation of a CHIKV virus-like particle (VLP) vaccine.
METHODS


This randomised, double-blind, parallel-group, phase 2 trial was conducted at three clinical trial centres in the USA. Eligible participants were healthy CHIKV-naïve adults aged 18-45 years. Participants were stratified by site and randomly assigned (1:1:1:1:1:1:1:1) to one of the eight vaccination groups using a block size of 16. Group 1 received two doses of unadjuvanted PXVX0317 28 days apart (2 × 20 μg; standard); all other groups received adjuvanted PXVX0317: groups 2-4 received two doses 28 days apart (2 × 6 μg [group 2], 2 × 10 μg [group 3], or 2 × 20 μg [group 4]; standard); group 4 also received a booster dose 18 months after the first active injection (40 μg; standard plus booster); groups 5-7 received two doses 14 days apart (2 × 6 μg [group 5], 2 × 10 μg [group 6], or 2 × 20 μg [group 7]; accelerated); and group 8 received one dose (1 × 40 μg; single). The primary endpoint was the geometric mean titre of anti-CHIKV neutralising antibody on day 57 (28 days after the last vaccination), assessed in the immunogenicity-evaluable population. Additionally, we assessed safety. This trial is registered at ClinicalTrials.gov, NCT03483961.
FINDINGS


This trial was conducted from April 18, 2018, to Sept 21, 2020; 468 participants were assessed for eligibility. Of these, 415 participants were randomly assigned to eight groups (n=53 in groups 1, 5, and 6; n=52 in groups 2 and 8; n=51 in groups 3 and 7; and n=50 in group 4) and 373 were evaluable for immunogenicity. On day 57, serum neutralising antibody geometric mean titres were 2057·0 (95% CI 1584·8-2670·0) in group 1, 1116·2 (852·5-1461·4; p=0·0015 vs group 1 used as a reference) in group 2, 1465·3 (1119·1-1918·4; p=0·076) in group 3, 2023·8 (1550·5-2641·7; p=0·93) in group 4, 920·1 (710·9-1190·9; p<0·0001) in group 5, 1206·9 (932·4-1562·2; p=0·0045) in group 6, 1562·8 (1204·1-2028·3; p=0·14) in group 7, and 1712·5 (1330·0-2205·0; p=0·32) in group 8. In group 4, a booster dose increased serum neutralising antibody geometric mean titres from 215·7 (95% CI 160·9-289·1) on day 547 to 10 941·1 (7378·0-16 225·1) on day 575. Durability of the immune response (evaluated in groups 1, 4, and 8) was shown up to 2 years. The most common solicited adverse event was pain at the injection site, reported in 12 (23%) of 53 participants who received the unadjuvanted vaccine (group 1) and 111 (31%) of 356 who received the adjuvanted vaccine. No vaccine-related serious adverse events were reported.
INTERPRETATION


PXVX0317 was well tolerated and induced a robust and durable serum neutralising antibody immune response against CHIKV up to 2 years. A single 40 μg injection of adjuvanted PXVX0317 is being further investigated in phase 3 clinical trials (NCT05072080 and NCT05349617).
FUNDING


Emergent BioSolutions.",2022,PXVX0317 was well tolerated and induced a robust and durable serum neutralising antibody immune response against CHIKV up to 2 years.,"['Eligible participants were healthy CHIKV-naïve adults aged 18-45 years', '1116·2', 'April 18, 2018, to Sept 21, 2020; 468 participants were assessed for eligibility', '415 participants']","['1712·5 (1330·0-2205·0', 'unadjuvanted vaccine', 'adjuvanted PXVX0317', 'aluminium hydroxide-adjuvanted formulation of a CHIKV virus-like particle (VLP) vaccine', 'unadjuvanted PXVX0317 28 days apart', 'PXVX0317', 'aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine']","['serum neutralising antibody geometric mean titres', 'geometric mean titre of anti-CHIKV neutralising antibody']","[{'cui': 'C0008056', 'cui_str': 'Chikungunya virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517772', 'cui_str': '415'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0008056', 'cui_str': 'Chikungunya virus'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0008056', 'cui_str': 'Chikungunya virus'}]",468.0,0.272469,PXVX0317 was well tolerated and induced a robust and durable serum neutralising antibody immune response against CHIKV up to 2 years.,"[{'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Bennett', 'Affiliation': 'Emergent BioSolutions, Gaithersburg, MD, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'McCarty', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'Emergent BioSolutions, Gaithersburg, MD, USA; GlaxoSmithKline Pharmaceuticals, Philadelphia, PA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mendy', 'Affiliation': 'Emergent BioSolutions, Gaithersburg, MD, USA.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Richardson', 'Affiliation': 'Emergent BioSolutions, Gaithersburg, MD, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Emergent BioSolutions, Gaithersburg, MD, USA; VLP Therapeutics, Gaithersburg, MD, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Alexander', 'Affiliation': 'Emergent BioSolutions, Gaithersburg, MD, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, US National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Paul-André', 'Initials': 'PA', 'LastName': 'de Lame', 'Affiliation': 'Anabase International, Lambertville, NJ, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Royalty Tredo', 'Affiliation': 'Emergent BioSolutions, Gaithersburg, MD, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Warfield', 'Affiliation': 'Emergent BioSolutions, Gaithersburg, MD, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bedell', 'Affiliation': 'Emergent BioSolutions, Gaithersburg, MD, USA. Electronic address: bedelll@ebsi.com.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(22)00226-2']
2287,35710450,Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial.,"BACKGROUND


Delivering acute hospital care to patients at home might reduce costs and improve patient experience. Mayo Clinic's Advanced Care at Home (ACH) program is a novel virtual hybrid model of ""Hospital at Home."" This pragmatic randomized controlled non-inferiority trial aims to compare two acute care delivery models: ACH vs. traditional brick-and-mortar hospital care in acutely ill patients.
METHODS


We aim to enroll 360 acutely ill adult patients (≥18 years) who are admitted to three hospitals in Arizona, Florida, and Wisconsin, two of which are academic medical centers and one is a community-based practice. The eligibility criteria will follow what is used in routine practice determined by local clinical teams, including clinical stability, social stability, health insurance plans, and zip codes. Patients will be randomized 1:1 to ACH or traditional inpatient care, stratified by site. The primary outcome is a composite outcome of all-cause mortality and 30-day readmission. Secondary outcomes include individual outcomes in the composite endpoint, fall with injury, medication errors, emergency room visit, transfer to intensive care unit (ICU), cost, the number of days alive out of hospital, and patient-reported quality of life. A mixed-methods study will be conducted with patients, clinicians, and other staff to investigate their experience.
DISCUSSION


The pragmatic trial will examine a novel virtual hybrid model for delivering high-acuity medical care at home. The findings will inform patient selection and future large-scale implementation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT05212077. Registered on 27 January 2022.",2022,"Secondary outcomes include individual outcomes in the composite endpoint, fall with injury, medication errors, emergency room visit, transfer to intensive care unit (ICU), cost, the number of days alive out of hospital, and patient-reported quality of life.","['360 acutely ill adult patients (≥18 years) who are admitted to three hospitals in Arizona, Florida, and Wisconsin, two of which are academic medical centers and one is a community-based practice', ""Mayo Clinic's Advanced Care at Home (ACH) program"", 'acutely ill patients', 'acutely ill adults']","['ACH', 'hospital-at-home vs. traditional brick-and-mortar hospital care', 'ACH vs. traditional brick-and-mortar hospital care']","['individual outcomes in the composite endpoint, fall with injury, medication errors, emergency room visit, transfer to intensive care unit (ICU), cost, the number of days alive out of hospital, and patient-reported quality of life', 'composite outcome of all-cause mortality and 30-day readmission']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",,0.247892,"Secondary outcomes include individual outcomes in the composite endpoint, fall with injury, medication errors, emergency room visit, transfer to intensive care unit (ICU), cost, the number of days alive out of hospital, and patient-reported quality of life.","[{'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. yao.xiaoxi@mayo.edu.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Paulson', 'Affiliation': 'Division of Hospital Internal Medicine, Mayo Clinic Health Systems, Eau Claire, WI, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Maniaci', 'Affiliation': 'Division of Hospital Internal Medicine, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Ajani N', 'Initials': 'AN', 'LastName': 'Dunn', 'Affiliation': 'Administrative Operations, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Chad R', 'Initials': 'CR', 'LastName': 'Nelson', 'Affiliation': 'Division of Hospital Internal Medicine, Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Behnken', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Hart', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Sangaralingham', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Shealeigh A', 'Initials': 'SA', 'LastName': 'Inselman', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Lampman', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Dunlay', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Dowdy', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Habermann', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}]",Trials,['10.1186/s13063-022-06430-6']
2288,35710449,Implementation of patient-reported outcomes for symptom management in oncology practice through the SIMPRO research consortium: a protocol for a pragmatic type II hybrid effectiveness-implementation multi-center cluster-randomized stepped wedge trial.,"BACKGROUND


Many cancer patients experience high symptom burden. Healthcare in the USA is reactive, not proactive, and doctor-patient communication is often suboptimal. As a result, symptomatic patients may suffer between clinic visits. In research settings, systematic assessment of electronic patient-reported outcomes (ePROs), coupled with clinical responses to severe symptoms, has eased this symptom burden, improved health-related quality of life, reduced acute care needs, and extended survival. Implementing ePRO-based symptom management programs in routine care is challenging. To study methods to overcome the implementation gap and improve symptom control for cancer patients, the National Cancer Institute created the Cancer-Moonshot funded Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium.
METHODS


Symptom Management IMplementation of Patient Reported Outcomes in Oncology (SIMPRO) is one of three research centers that make up the IMPACT Consortium. SIMPRO, a multi-disciplinary team of investigators from six US health systems, seeks to develop, test, and integrate an electronic symptom management program (eSyM) for medical oncology and surgery patients into the Epic electronic health record (EHR) system and associated patient portal. eSyM supports real-time symptom tracking for patients, automated clinician alerts for severe symptoms, and specialized reports to facilitate population management. To rigorously evaluate its impact, eSyM is deployed through a pragmatic stepped wedge cluster-randomized trial. The primary study outcome is the occurrence of an emergency department treat-and-release event within 30 days of starting chemotherapy or being discharged following surgery. Secondary outcomes include hospitalization rates, chemotherapy use (time to initiation and duration of therapy), and patient quality of life and satisfaction. As a type II hybrid effectiveness-implementation study, facilitators and barriers to implementation are assessed throughout the project.
DISCUSSION


Creating and deploying eSyM requires collaboration between dozens of staff across diverse health systems, dedicated engagement of patient advocates, and robust support from Epic. This trial will evaluate eSyM in routine care settings across academic and community-based healthcare systems serving patients in rural and metropolitan locations. This trial's pragmatic design will promote generalizable results about the uptake, acceptability, and impact of an EHR-integrated, ePRO-based symptom management program.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03850912 . Registered on February 22, 2019. Last updated on November 9, 2021.",2022,"Secondary outcomes include hospitalization rates, chemotherapy use (time to initiation and duration of therapy), and patient quality of life and satisfaction.","['cancer patients', 'cancer patients experience high symptom burden', 'routine care settings across academic and community-based healthcare systems serving patients in rural and metropolitan locations']",['eSyM'],"['occurrence of an emergency department treat-and-release event within 30 days of starting chemotherapy or being discharged following surgery', 'hospitalization rates, chemotherapy use (time to initiation and duration of therapy), and patient quality of life and satisfaction']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0450429', 'cui_str': 'Location'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.183427,"Secondary outcomes include hospitalization rates, chemotherapy use (time to initiation and duration of therapy), and patient quality of life and satisfaction.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hassett', 'Affiliation': ""Dana-Farber Cancer Institute/Brigham and Women's Hospital, 450 Brookline Avenue, Boston, MA, 02215, USA. michael_hassett@dfci.harvard.edu.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Raymond U', 'Initials': 'RU', 'LastName': 'Osarogiagbon', 'Affiliation': 'Baptist Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bian', 'Affiliation': 'Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Don S', 'Initials': 'DS', 'LastName': 'Dizon', 'Affiliation': 'Lifespan Cancer Institute and Brown University, Providence, RI, USA.'}, {'ForeName': 'Hannah Hazard', 'Initials': 'HH', 'LastName': 'Jenkins', 'Affiliation': 'West Virginia University Cancer Center, Morgantown, WV, USA.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Uno', 'Affiliation': ""Dana-Farber Cancer Institute/Brigham and Women's Hospital, 450 Brookline Avenue, Boston, MA, 02215, USA.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cronin', 'Affiliation': ""Dana-Farber Cancer Institute/Brigham and Women's Hospital, 450 Brookline Avenue, Boston, MA, 02215, USA.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schrag', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-022-06435-1']
2289,35710448,Internet-based vestibular rehabilitation versus standard care after acute onset vertigo: a study protocol for a randomized controlled trial.,"BACKGROUND


Dizziness and vertigo affect around 15% of adults annually and represent common reasons for contacting health services, accounting for around 3% of all emergency department visits worldwide. Vertigo is also associated with excessive use of diagnostic imaging and emergency care and decreased productivity, primarily because of work absenteeism. Vestibular rehabilitation is an evidence-based treatment for chronic dizziness and supervised group exercise therapy has recently been shown to be effective after vestibular neuritis, a common cause of acute onset vertigo. However, such interventions are not readily available and there is a need for more easily accessible tools. The purpose of this study is to investigate the effects on vestibular symptoms of a 6-week online vestibular rehabilitation tool after acute onset vertigo, with the aim of aiding vestibular rehabilitation by presenting a more accessible tool that can help to reduce recovery time.
METHODS


Three hundred twenty individuals diagnosed with acute vestibular syndrome (AVS) will be recruited from multiple hospitals in Sweden and the effects of an online vestibular rehabilitation tool, YrselTräning, on vestibular symptoms after acute onset vertigo will be compared to standard care (written instructions leaflet) in a two-armed, evaluator-blinded, multicenter randomized controlled trial. The primary outcome will be the Vertigo Symptom Scale Short Form (VSS-SF) score at 6 weeks after symptom onset. Secondary outcomes include effects of the intervention on activities of daily living, mood and anxiety, vestibular function recovery, mobility measures, health economic effects, and the reliability of the Swedish VSS-SF translation.
DISCUSSION


Participants using the online vestibular rehabilitation tool are expected to recover earlier and to a greater extent from their symptoms as compared to standard care. Since up to 50% of people with AVS without treatment develop persistent symptoms, effective treatment of AVS will likely lead to a higher quality of life and help reduce the societal costs associated with dizziness and vertigo.
TRIAL REGISTRATION


Clinicaltrials.gov NCT05056324 . Registered on September 24, 2021.",2022,"Secondary outcomes include effects of the intervention on activities of daily living, mood and anxiety, vestibular function recovery, mobility measures, health economic effects, and the reliability of the Swedish VSS-SF translation.
","['Three hundred twenty individuals diagnosed with acute vestibular syndrome (AVS) will be recruited from multiple hospitals in Sweden and the effects of an online vestibular rehabilitation tool, YrselTräning, on vestibular symptoms after acute onset vertigo', 'after acute onset vertigo']","['Vestibular rehabilitation', 'Internet-based vestibular rehabilitation versus standard care']","['Vertigo Symptom Scale Short Form (VSS-SF) score', 'activities of daily living, mood and anxiety, vestibular function recovery, mobility measures, health economic effects, and the reliability of the Swedish VSS-SF translation']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1504381', 'cui_str': 'Acute vestibular syndrome'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0040712', 'cui_str': 'Translations'}]",320.0,0.137927,"Secondary outcomes include effects of the intervention on activities of daily living, mood and anxiety, vestibular function recovery, mobility measures, health economic effects, and the reliability of the Swedish VSS-SF translation.
","[{'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Surano', 'Affiliation': 'Department of Clinical Sciences, Neurosciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Grip', 'Affiliation': 'Department of Radiation Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Öhberg', 'Affiliation': 'Department of Radiation Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical Sciences, Neurosciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Faergemann', 'Affiliation': 'Department of Clinical Sciences, Neurosciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bjurman', 'Affiliation': 'Sollefteå Hospital, Region Västernorrland, Sollefteå, Sweden.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Davidsson', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Ledin', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Lindell', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mathé', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet and Capio S:t Görans Hospital, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Tjernström', 'Affiliation': 'Department of Clinical Sciences, Othorhinolaryngology, Lund University, Lund, Sweden.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Tomanovic', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Granåsen', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Jonatan', 'Initials': 'J', 'LastName': 'Salzer', 'Affiliation': 'Department of Clinical Sciences, Neurosciences, Umeå University, Umeå, Sweden. jonatan.salzer@umu.se.'}]",Trials,['10.1186/s13063-022-06460-0']
2290,35710447,"Study protocol for a randomised, patient- and observer-blinded evaluation of P6 acustimulation for the prevention of nausea and vomiting in the postoperative period in patients receiving routine pharmacological prophylaxis (P6NV-Trial).","BACKGROUND


The efficacy of pericardium 6 (P6) acupoint stimulation to reduce the incidence of postoperative nausea and vomiting (PONV) has been proven in several randomised controlled clinical trials. However, little is known about the effectiveness in daily practice and its use in combination with traditional pharmacologic approaches.
METHODS


The primary objective of the P6NV study is to determine whether intraoperative acustimulation (acupuncture or acupressure) at the point P6 provides additional benefit when applied along with customary prophylactic intravenous antiemetics administered according to the local standard operating procedures (SOP). The primary endpoint is the incidence and severity of PONV within the first 24 h postoperatively reported with a validated postoperative nausea and vomiting intensity scale. The patient-reported outcome of perioperative quality of life (using the PPP33-questionnaire) and the detection of antiemetic-related side effects as well as the severity of PONV (via a standardised questionnaire) are secondary study objectives. P6NV is a national, multicentre, randomised, prospective, patient- and examiner-blinded interventional study and will be performed on 3500 adult patients with ASA classification I-III undergoing elective surgery under general anaesthesia and hospitalised for at least 24 h. Participating anaesthesiologists commit themselves to administer customised conventional antiemetic prophylaxis according to the local SOP by signing a statement before randomisation. The intervention group receives bilateral acupuncture or acupressure at P6. The control group receives no intervention. Before extubation, acustimulation is removed.
DISCUSSION


Since P6 acustimulation is performed by a wide range of anaesthesiologists receiving written and verbal information on acustimulation beforehand, this trial will provide information on the effectiveness of an ad hoc implementation of P6 stimulation techniques in anaesthesia departments using traditional pharmacologic PONV prophylaxis.
TRIAL REGISTRATION


DRKS DRKS00015272 . Registered on August 15, 2018.",2022,The control group receives no intervention.,"['patients receiving routine pharmacological prophylaxis (P6NV-Trial', '3500 adult patients with ASA classification I-III undergoing elective surgery under general anaesthesia and hospitalised for at least 24 h. Participating anaesthesiologists commit themselves to administer customised conventional antiemetic prophylaxis according to the local SOP by signing a statement before randomisation']","['bilateral acupuncture or acupressure at P6', 'P6 acustimulation', 'pericardium 6 (P6) acupoint stimulation', 'intraoperative acustimulation (acupuncture or acupressure']","['nausea and vomiting', 'incidence and severity of PONV within the first 24 h postoperatively reported with a validated postoperative nausea and vomiting intensity scale', 'perioperative quality of life', 'postoperative nausea and vomiting (PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0031050', 'cui_str': 'Pericardial sac structure'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",3500.0,0.249848,The control group receives no intervention.,"[{'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Philipps-University of Marburg, Marburg, Germany.'}, {'ForeName': 'Selena', 'Initials': 'S', 'LastName': 'Knoth', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Philipps-University of Marburg, Marburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kranke', 'Affiliation': 'Department of Anaesthesia and Critical Care, University Hospitals of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Eberhart', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Philipps-University of Marburg, Marburg, Germany. eberhart@staff.uni-marburg.de.'}]",Trials,['10.1186/s13063-022-06369-8']
2291,35710445,"Reducing household air pollution exposure to improve early child growth and development; a randomized control trial protocol for the ""Poriborton-Extension: The CHANge trial"".","BACKGROUND


Globally, household air pollution (HAP) is a leading environmental cause of morbidity and mortality. Our trial aims to assess the impact of liquefied petroleum gas (LPG) for cooking to reduce household air pollution exposure on child health outcomes, compared to usual cooking practices in Bangladesh. The primary aim is to evaluate if reduced exposure to HAP through the provision of LPG for cooking from early gestation through to age 2 improves child anthropometry, health, and neuro-cognitive developmental outcomes, compared to children exposed to emissions from usual practice.
METHODS


Two-arm parallel cluster randomized controlled trial (cCRT). We will extend the intervention and follow-up of our existing ""Poriborton"" trial. In a subset of the original surviving participants, we will supply LPG cylinders and LPG stoves (intervention) compared to usual cooking practices and extend the follow-up to 24 months of age. The expected final sample size, for both (intervention and control) is 1854 children with follow-up to 2 years of age available for analysis.
DISCUSSION


This trial will answer important research gaps related to HAP and child health and neuro-cognitive developmental outcomes. This evidence will help to understand the impact of a HAP intervention on child health to inform policies for the adoption of clean fuel in Bangladesh and other similar settings.
TRIAL REGISTRATION


The Poriborton: Change trial: Household Air Pollution and Perinatal and early Neonatal mortality is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001214224, original trial registered on 19th July 2018, extension approved on 23rd June 2021. www.anzctr.org.au .",2022,"The expected final sample size, for both (intervention and control) is 1854 children with follow-up to 2 years of age available for analysis.
","['Bangladesh', '19th July 2018, extension approved on 23rd June 2021', '1854 children with follow-up to 2\xa0years of age available for analysis']","['HAP intervention', 'liquefied petroleum gas (LPG', 'www.anzctr.org.au ']",[],"[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}]",[],,0.277823,"The expected final sample size, for both (intervention and control) is 1854 children with follow-up to 2 years of age available for analysis.
","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Raynes-Greenow', 'Affiliation': 'The University of Sydney, School of Public Health, Sydney, Australia. camille.raynes-greenow@sydney.edu.au.'}, {'ForeName': 'Sk Masum', 'Initials': 'SM', 'LastName': 'Billah', 'Affiliation': 'The University of Sydney, School of Public Health, Sydney, Australia.'}, {'ForeName': 'Sajia', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Maternal and Child Health Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Rokonuzzaman', 'Affiliation': 'Maternal and Child Health Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Tofail', 'Affiliation': 'Maternal and Child Health Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Kirkwood', 'Affiliation': 'The University of Sydney, School of Public Health, Sydney, Australia.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'The University of Sydney, School of Public Health, Sydney, Australia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Chartier', 'Affiliation': 'RTI International, Research Triangle Park, NC, 27707, USA.'}, {'ForeName': 'Tarana E', 'Initials': 'TE', 'LastName': 'Ferdous', 'Affiliation': 'Maternal and Child Health Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Shams', 'Initials': 'S', 'LastName': 'El Arifeen', 'Affiliation': 'Maternal and Child Health Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'The University of Sydney, School of Public Health, Sydney, Australia.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Homaira', 'Affiliation': 'UNSW, Sydney, Kensington, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hayes', 'Affiliation': 'The University of Sydney, School of Public Health, Sydney, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Thornburg', 'Affiliation': 'RTI International, Research Triangle Park, NC, 27707, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'The University of Sydney, School of Public Health, Sydney, Australia.'}]",Trials,['10.1186/s13063-022-06342-5']
2292,35710320,Plasma neurofilament light chain levels suggest neuroaxonal stability following therapeutic remyelination in people with multiple sclerosis.,"BACKGROUND


Chronic demyelination is a major contributor to axonal vulnerability in multiple sclerosis (MS). Therefore, remyelination could provide a potent neuroprotective strategy. The ReBUILD trial was the first study showing evidence for successful remyelination following treatment with clemastine in people with MS (pwMS) with no evidence of disease activity or progression (NEDAP). Whether remyelination was associated with neuroprotection remains unexplored.
METHODS


Plasma neurofilament light chain (NfL) levels were measured from ReBUILD trial's participants. Mixed linear effect models were fit for individual patients, epoch and longitudinal measurements to compare NfL concentrations between samples collected during the active and placebo treatment period.
RESULTS


NfL concentrations were 9.6% lower in samples collected during the active treatment with clemastine (n=53, geometric mean=6.33 pg/mL) compared to samples collected during treatment with placebo (n=73, 7.00 pg/mL) (B=-0.035 [-0.068 to -0.001], p=0.041). Applying age- and body mass index-standardised NfL Z-scores and percentiles revealed similar results (0.04 vs 0.35, and 27.5 vs 33.3, p=0.023 and 0.042, respectively). Higher NfL concentrations were associated with more delayed P100 latencies (B=1.33 [0.26 to 2.41], p=0.015). In addition, improvement of P100 latencies between visits was associated with a trend for lower NfL values (B=0.003 [-0.0004 to 0.007], p=0.081). Based on a Cohen's d of 0.248, a future 1:1 parallel-arm placebo-controlled study using a remyelinating agent with comparable effect as clemastine would need 202 subjects per group to achieve 80% power.
CONCLUSIONS


In pwMS, treatment with the remyelinating agent clemastine was associated with a reduction of blood NfL, suggesting that neuroprotection is achievable and measurable with therapeutic remyelination.
TRIAL REGISTRATION NUMBER


NCT02040298.",2022,"Higher NfL concentrations were associated with more delayed P100 latencies (B=1.33 [0.26 to 2.41], p=0.015).","['people with multiple sclerosis', 'people with MS (pwMS) with no evidence of disease activity or progression (NEDAP']","['clemastine', 'placebo']","['NfL concentrations', 'P100 latencies', 'delayed P100 latencies']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0008929', 'cui_str': 'Clemastine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",,0.116829,"Higher NfL concentrations were associated with more delayed P100 latencies (B=1.33 [0.26 to 2.41], p=0.015).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdelhak', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Cordano', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'W John', 'Initials': 'WJ', 'LastName': 'Boscardin', 'Affiliation': 'Departments of Medicine and Epidemiology & Biostatistics, University of California at San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Caverzasi', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kuhle', 'Affiliation': 'Multiple Sclerosis Centre, Neurology, Departments of Head, Spine and Neuromedicine, Biomedicine and Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Chan', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Gelfand', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Hao H', 'Initials': 'HH', 'LastName': 'Yiu', 'Affiliation': 'Department of Biology, University of Maryland, College Park, Maryland, USA.'}, {'ForeName': 'Frederike C', 'Initials': 'FC', 'LastName': 'Oertel', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Beaudry-Richard', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Shivany', 'Initials': 'S', 'LastName': 'Condor Montes', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Oksenberg', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Argentina', 'Initials': 'A', 'LastName': 'Lario Lago', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Boxer', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Rojas-Martinez', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Fanny M', 'Initials': 'FM', 'LastName': 'Elahi', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Jonah R', 'Initials': 'JR', 'LastName': 'Chan', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA.'}, {'ForeName': 'Ari J', 'Initials': 'AJ', 'LastName': 'Green', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco (UCSF), San Francisco, California, USA agreen@ucsf.edu.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2022-329221']
2293,35710254,Digital intervention promoting physical activity among obese people (DIPPAO) randomised controlled trial: study protocol.,"INTRODUCTION


Physical inactivity and excessive sedentary behaviours are major preventable causes in both the development and the treatment of obesity and type 2 diabetes mellitus (T2DM). Nevertheless, current programmes struggle to engage and sustain physical activity (PA) of patients over long periods of time. To overcome these limitations, the Digital Intervention Promoting Physical Activity among Obese people randomised controlled trial (RCT) aims to evaluate the effectiveness of a group-based digital intervention grounded on gamification strategies, enhanced by social features and informed by the tenets of the self-determination theory and the social identity approach.
METHODS AND ANALYSIS


This trial is a two-arm parallel RCT testing the effectiveness of the Kiplin digital intervention on obese and patients with T2DM in comparison to the usual supervised PA programme of the University Hospital of Clermont-Ferrand, France. A total of 50 patients will be randomised to one of the two interventions and will follow a 3-month programme with a 6-month follow-up postintervention. The primary outcome of the study is the daily step count change between the baseline assessment and the end of the intervention. Accelerometer data, self-reported PA, body composition and physical capacities will also be evaluated. To advance our understanding of complex interventions like gamified and group-based ones, we will explore several psychological mediators relative to motivation, enjoyment, in-group identification or perceived weight stigma. Finally, to assess a potential superior economic efficiency compared with the current treatment, we will conduct a cost-utility analysis between the two conditions. A mixed-model approach will be used to analyse the change in outcomes over time.
ETHICS AND DISSEMINATION


The research protocol has been reviewed and approved by the Local Human Protection Committee (CPP Ile de France XI, No 21 004-65219). Results will inform the Kiplin app development, be published in scientific journals and disseminated in international conferences.
TRIAL REGISTRATION NUMBER


NCT04887077.",2022,"This trial is a two-arm parallel RCT testing the effectiveness of the Kiplin digital intervention on obese and patients with T2DM in comparison to the usual supervised PA programme of the University Hospital of Clermont-Ferrand, France.","['obese people (DIPPAO', '50 patients', 'obese and patients with T2DM in comparison to the usual supervised PA programme of the University Hospital of Clermont-Ferrand, France']","['Digital intervention', 'Kiplin digital intervention', 'Digital Intervention']","['Accelerometer data, self-reported PA, body composition and physical capacities']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.0455783,"This trial is a two-arm parallel RCT testing the effectiveness of the Kiplin digital intervention on obese and patients with T2DM in comparison to the usual supervised PA programme of the University Hospital of Clermont-Ferrand, France.","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mazéas', 'Affiliation': 'SENS, Univ. Grenoble Alpes, 38000 Grenoble, France alexandre.mazeas@univ-grenoble-alpes.fr.'}, {'ForeName': 'Aïna', 'Initials': 'A', 'LastName': 'Chalabaev', 'Affiliation': 'SENS, Univ. Grenoble Alpes, 38000 Grenoble, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Blond', 'Affiliation': 'Kiplin, Nantes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Department of Biostatistics Unit (DRCI), University Hospital Centre, Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Human Nutrition, INRAE Centre Clermont-Auvergne-Rhône-Alpes, Clermont-Ferrand, France.'}]",BMJ open,['10.1136/bmjopen-2021-058015']
2294,35710253,"Effect of beetroot or beetroot plus vitamin C supplementation on cardiovascular function in patients with coronary artery disease: protocol for a double-blind, placebo-controlled, randomised trial.","INTRODUCTION


Coronary artery disease (CAD), classified into the atherosclerosis category, is a prevalent cardiovascular disease worldwide that is associated with serious comorbidities and death. The purpose of this study was to evaluate the effect of beetroot/beetroot plus vitamin C on cardiovascular health status and function in patients with CAD.
METHOD AND ANALYSIS


A randomised, placebo-controlled, double-blind clinical trial to recruit 90 patients with CAD at the cardiac outpatient clinic and Imam Reza Hospital, Mashhad, Iran. Participants will be divided into three groups: (1) Those who receive 500 mg three times a day of beetroot capsules, (2) Those who receive 500 mg three times a day of beetroot plus vitamin C capsules, and (3) Those who receive placebo capsules three times a day for 4 weeks. Pulse wave velocity, Augmentation Index, heart rate, volume of oxygen (VO 2 ) max/VO 2  peak, peak heart rate, blood pressure, interleukin 6 (IL-6), high sensitivity C reactive protein, intercellular adhesion molecule, vascular cell adhesion molecule, lipid profile and anthropometry will be measured at the beginning and end of the intervention.
ETHICS AND DISSEMINATION


This study was approved by the Ethics Committee of Mashhad University of Medical Sciences (IR.MUMS.MEDICAL.REC.1399.717). All participants will be asked to complete the consent form at the beginning of the study. The results will be actively disseminated through peer-reviewed journals and conference presentations.
TRIAL REGISTRATION NUMBER


Iranian Registry of Clinical Trials, IRCT20210217050393N1 (registered 16 May 2021).",2022,"A randomised, placebo-controlled, double-blind clinical trial to recruit 90 patients with CAD at the cardiac outpatient clinic and Imam Reza Hospital, Mashhad, Iran.","['patients with coronary artery disease', '90 patients with CAD at the cardiac outpatient clinic and Imam Reza Hospital, Mashhad, Iran', 'patients with CAD']","['beetroot or beetroot plus vitamin C supplementation', 'beetroot/beetroot plus vitamin C', 'placebo', 'receive 500\u2009mg three times a day of beetroot capsules, (2) Those who receive 500\u2009mg three times a day of beetroot plus vitamin C capsules, and (3) Those who receive placebo']","['Pulse wave velocity, Augmentation Index, heart rate, volume of oxygen (VO 2 ) max/VO 2  peak, peak heart rate, blood pressure, interleukin 6 (IL-6), high sensitivity C reactive protein, intercellular adhesion molecule, vascular cell adhesion molecule, lipid profile and anthropometry will be measured at the beginning and end of the intervention', 'cardiovascular function', 'cardiovascular health status and function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",90.0,0.538492,"A randomised, placebo-controlled, double-blind clinical trial to recruit 90 patients with CAD at the cardiac outpatient clinic and Imam Reza Hospital, Mashhad, Iran.","[{'ForeName': 'Leila Sadat', 'Initials': 'LS', 'LastName': 'Bahrami', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mohebaty', 'Affiliation': 'Cardiovascular Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyyed Mostafa', 'Initials': 'SM', 'LastName': 'Arabi', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Tabesh', 'Affiliation': 'Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Nematy', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rezvani', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran rezarezvani991@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2022-061394']
2295,35710251,Digital cognitive training in children with attention-deficit/hyperactivity disorder: a study protocol of a randomised controlled trial.,"INTRODUCTION


Attention-deficit/hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders and is a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with daily functioning. Children with ADHD are developmentally vulnerable, with the disorder linked to emotional regulation difficulties, behavioural disturbances, as well as academic challenges. Emerging evidence suggests that children with ADHD may benefit from cognitive training interventions, including those focused on attention. This study aims to assess the immediate and long-term efficacy of an attention training intervention in children with ADHD.
METHODS AND ANALYSIS


This study is a preregistered, parallel, double blind, randomised controlled trial. Participants will comprise 104 children with a diagnosis of ADHD aged 5-8 years 11 months. Participants will be randomly allocated to either an adaptive, digital game-based (1) attention training programme (intervention) or (2) a numeracy programme (control). Both programmes will be delivered on a touchscreen tablet, and children will complete five 20 min sessions per week for a 5-week period at home (25 sessions in total). Assessments of the primary outcome (ie, attention and inhibitory control) and secondary outcomes (ie, selective attention, interference control, sustained attention, inhibition, behavioural attention, impairment in everyday functioning, working memory and executive functioning) will occur at preintervention, immediately postintervention and at 3-month follow-up. Multivariate linear regression will be employed to examine primary and secondary outcomes. The data analyst will be blinded to group membership.
ETHICS AND DISSEMINATION


Ethics approval has been obtained from the Monash University HREC (20495). Results will be disseminated through peer-reviewed journals, conference presentations, media outlets, the internet and various community/stakeholder activities.
TRIAL REGISTRATION NUMBER


ACTRN12620000964910, UTN U1111-1250-2620.",2022,"Participants will be randomly allocated to either an adaptive, digital game-based (1) attention training programme (intervention) or (2) a numeracy programme (control).","['Children with ADHD', 'children with ADHD', 'children with attention-deficit/hyperactivity disorder', '104 children with a diagnosis of ADHD aged 5-8 years 11 months']","['attention training intervention', 'Digital cognitive training', 'adaptive, digital game-based (1) attention training programme (intervention) or (2) a numeracy programme (control']","['primary outcome (ie, attention and inhibitory control) and secondary outcomes (ie, selective attention, interference control, sustained attention, inhibition, behavioural attention, impairment in everyday functioning, working memory and executive functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0556509', 'cui_str': 'Attention training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",104.0,0.20025,"Participants will be randomly allocated to either an adaptive, digital game-based (1) attention training programme (intervention) or (2) a numeracy programme (control).","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Richmond', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Kirk', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Tori', 'Initials': 'T', 'LastName': 'Gaunson', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Bennett', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Bellgrove', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Cornish', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia kim.cornish@monash.edu.'}]",BMJ open,['10.1136/bmjopen-2021-055385']
2296,35710247,Structured follow-up pathway to support people after transient ischaemic attack and minor stroke (SUPPORT TIA): protocol for a feasibility study and process evaluation.,"INTRODUCTION


People who experience transient ischaemic attack (TIA) and minor stroke have limited follow-up despite rapid specialist review in hospital. This means they often have unmet needs and feel abandoned following discharge. Care needs after TIA/minor stroke include information provision (diagnosis and stroke risk), stroke prevention (medication and lifestyle change) and holistic care (residual problems and return to work or usual activities). This protocol describes a feasibility study and process evaluation of an intervention to support people after TIA/minor stroke. The study aims to assess the feasibility and acceptability of (1) the intervention and (2) the trial procedures for a future randomised controlled trial of this intervention.
METHODS AND ANALYSIS


This is a multicentre, randomised (1:1) feasibility study with a mixed-methods process evaluation. Sixty participants will be recruited from TIA clinics or stroke wards at three hospital sites (England). Intervention arm participants will be offered a nurse or allied health professional-led follow-up appointment 4 weeks after TIA/minor stroke. The multifaceted intervention includes: a needs checklist, action plan, resources to support management of needs, a general practitioner letter and training to deliver the intervention. Control arm participants will receive usual care. Follow-up will be self-completed questionnaires (12 weeks and 24 weeks) and a clinic appointment (24 weeks). Follow-up questionnaires will measure anxiety, depression, fatigue, health related quality of life, self-efficacy and medication adherence. The clinic appointment will collect body mass index, blood pressure, cholesterol and medication. Assessment of feasibility and acceptability will include quantitative process variables (such as recruitment and questionnaire response rates), structured observations of study processes, and interviews with a subsample of participants and clinical staff.
ETHICS AND DISSEMINATION


Favourable ethical opinion was gained from the Wales Research Ethics Committee (REC) 1 (23 February 2021, REC reference: 21/WA/0036). Study results will be published in peer-reviewed journals and presented at conferences. A lay summary and dissemination strategy will be codesigned with consumers. The lay summary and journal publication will be distributed on social media.
TRIAL REGISTRATION NUMBER


ISRCTN39864003.",2022,"Follow-up questionnaires will measure anxiety, depression, fatigue, health related quality of life, self-efficacy and medication adherence.","['Sixty participants will be recruited from TIA clinics or stroke wards at three hospital sites (England', 'support people after TIA/minor stroke', 'People who experience transient ischaemic attack (TIA) and minor stroke']","['needs checklist, action plan, resources to support management of needs, a general practitioner letter and training to deliver the intervention']","['feasibility and acceptability', 'information provision (diagnosis and stroke risk), stroke prevention (medication and lifestyle change) and holistic care (residual problems and return to work or usual activities', 'anxiety, depression, fatigue, health related quality of life, self-efficacy and medication adherence']","[{'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",60.0,0.0361,"Follow-up questionnaires will measure anxiety, depression, fatigue, health related quality of life, self-efficacy and medication adherence.","[{'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'Turner', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK g.turner.1@bham.ac.uk.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Collis', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Smitaa', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Robbie', 'Initials': 'R', 'LastName': 'Foy', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Atkins', 'Affiliation': 'Centre for Behaviour Change, University College London, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Calvert', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}]",BMJ open,['10.1136/bmjopen-2021-060280']
2297,35714722,Development and Pilot Evaluation of a Decision Aid for Small Kidney Masses.,"OBJECTIVE


To develop and pilot test a patient decision aid (DA) describing small kidney masses and risks and benefits of treatment for the masses.
METHODS


An expert committee iteratively designed a small kidney mass DA, incorporating evidence-based risk communication and informational needs for treatment options and shared decision making. After literature review and drafting content with the feedback of urologists, radiologists, and an internist, a rapid qualitative assessment was conducted using two patient focus groups to inform user-centered design. In a pilot study, 30 patients were randomized at the initial urologic consultation to receive the DA or existing institutional patient educational material (PEM). Preconsultation questionnaires captured patient knowledge and shared decision-making preferences. After review of the DA and subsequent clinician consultation, patients completed questionnaires on discussion content and satisfaction. Proportions between arms were compared using Fisher exact tests, and decision measures were compared using Mann-Whitney tests.
RESULTS


Patient informational needs included risk of tumor growth during active surveillance and ablation, significance of comorbidities, and posttreatment recovery. For the DA, 84% of patients viewed all content, and mean viewing time was 20 min. Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, P < .001). DA use also increased the proportion of patients discussing ablation (66.7% DA versus 18.2% PEM, P = .02). Decision satisfaction measures were similar in both arms.
DISCUSSION


Patients receiving a small kidney mass DA are likely to gain knowledge and preparedness to discuss all treatment options over standard educational materials.",2022,"Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, P ","['Small Kidney Masses', '30 patients were randomized at the initial urologic consultation to receive the']",['DA or existing institutional patient educational material (PEM'],"['Decision satisfaction measures', 'knowledge about small mass risks', 'risk of tumor growth', 'mean viewing time', 'proportion of patients discussing ablation']","[{'cui': 'C0156247', 'cui_str': 'Small kidney'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",30.0,0.0423943,"Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, P ","[{'ForeName': 'Shailin A', 'Initials': 'SA', 'LastName': 'Thomas', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Mutita', 'Initials': 'M', 'LastName': 'Siriruchatanon', 'Affiliation': 'Department of Radiology, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Albert', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bjurlin', 'Affiliation': 'University of North Carolina Department of Urology, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Radiology, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Langford', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Braithwaite', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, New York; Department of Medicine, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Danil V', 'Initials': 'DV', 'LastName': 'Makarov', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, New York; NYU Department of Urology, New York, New York.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'University of Utah Department of Population Health Sciences, Salt Lake City, Utah; Chair, Population Health Sciences.'}, {'ForeName': 'Stella K', 'Initials': 'SK', 'LastName': 'Kang', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, New York; Department of Radiology, NYU Grossman School of Medicine, New York, New York; Chair, ACR Steering Committee on Incidental Findings; Specialty Chair, Appropriateness Criteria Expert Panel on Gynecologic and Obstetrical Imaging. Electronic address: stella.kang@nyulangone.org.'}]",Journal of the American College of Radiology : JACR,['10.1016/j.jacr.2022.05.017']
2298,35714715,Prevention of radial artery occlusion by simultaneous ulnar and radial compression (PRO-SURC). A randomized duplex ultrasound follow-up study.,"BACKGROUND


There might be a beneficial effect of transient ulnar artery compression in prevention of radial artery occlusion (RAO) after trans-radial catheterization. Objective The objective of this study was to assess, by Duplex ultrasound, the efficacy of simultaneous ulnar and radial artery compression (SURC), in prevention of RAO, compared to conventional and patent hemostasis techniques.
PATIENTS AND METHODS


Four hundred and fifty consecutive patients undergoing elective trans-radial catheterization were enrolled. Patients were randomized in 1:1:1 fashion into 3 groups; conventional hemostasis (Group A, n = 150 patients), patent hemostasis (Group B, n = 150 patients), and SURC technique (Group C, n = 150 patients). RAO was assessed by duplex ultrasound at 1-h post TR band removal (primary endpoint), and at 1-month.
RESULTS


The primary endpoint, RAO 1-h post TR-band removal, was significantly lower among patients of group C as compared to those of group A and B (1.3%, 6.7%, and 7.3%, respectively -p = 0.03). This was still consistent at 1-month (0.7%, 8%, and 6%, respectively -p = 0.03). Multiple regression analyses revealed that lower radial artery diameter (RAD) after flow-mediated dilatation (FMD) independently predicted RAO at 1-h, while RAD at 1-h post-TR band removal was the only independent predictor of RAO at 1-month. Receiver operator characteristic (ROC) analysis showed that RAD at 1-h post-TR band removal at cut-off ≤1.75 mm could predict RAO at 1-month with high accuracy (AUC = 0.9, CI = 0.8-1.0, p < 0.001-86% sensitivity, and 95% specificity).
CONCLUSION


A technique of SURC is associated with less incidence of early and late RAO compared to conventional hemostasis techniques.",2022,"The primary endpoint, RAO 1-h post TR-band removal, was significantly lower among patients of group C as compared to those of group A and B (1.3%, 6.7%, and 7.3%, respectively -p = 0.03).",['Four hundred and fifty consecutive patients undergoing elective trans-radial catheterization were enrolled'],"['SURC technique', 'patent hemostasis', 'conventional hemostasis', 'transient ulnar artery compression', 'radial artery occlusion by simultaneous ulnar and radial compression (PRO-SURC', 'simultaneous ulnar and radial artery compression (SURC']","['lower radial artery diameter (RAD', 'RAO 1-h post TR-band removal', 'RAO']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0406775', 'cui_str': 'Symmetrical dyschromatosis of extremities'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",450.0,0.0852382,"The primary endpoint, RAO 1-h post TR-band removal, was significantly lower among patients of group C as compared to those of group A and B (1.3%, 6.7%, and 7.3%, respectively -p = 0.03).","[{'ForeName': 'Tarek A N', 'Initials': 'TAN', 'LastName': 'Ahmed', 'Affiliation': 'Department of Cardiovascular medicine- Assiut University Hospital-, Egypt.. Electronic address: tarek.a.n.ahmed@med.aun.edu.eg.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Abbas', 'Affiliation': 'Department of Cardiovascular medicine- Assiut University Hospital-, Egypt.; Department of Cardiovascular medicine- Assiut University Hospital-, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Bakr', 'Affiliation': 'Department of Vascular and Endovascular surgery- Assiut University Hospital-, Egypt.; Department of Cardiovascular medicine- Assiut University Hospital-, Egypt.'}, {'ForeName': 'Salwa R', 'Initials': 'SR', 'LastName': 'Demitry', 'Affiliation': 'Department of Cardiovascular medicine- Assiut University Hospital-, Egypt.; Department of Cardiovascular medicine- Assiut University Hospital-, Egypt.'}, {'ForeName': 'Magdy I', 'Initials': 'MI', 'LastName': 'Algowhary', 'Affiliation': 'Department of Cardiovascular medicine- Assiut University Hospital-, Egypt.; Department of Cardiovascular medicine- Assiut University Hospital-, Egypt.'}]",International journal of cardiology,['10.1016/j.ijcard.2022.06.041']
2299,35714700,Provision of Home-Based Primary Care to Individuals With Intellectual and/or Developmental Disability Is Associated With a Lower Hospitalization Rate Than a Traditional Primary Care Model.,"OBJECTIVES


The objective of this study was to determine if providing home-based primary care (HBPC) to individuals with intellectual and/or developmental disabilities (IDDs) was associated with a lower hospitalization rate than a control group receiving traditional primary care.
DESIGN AND INTERVENTION


Individuals with IDDs living in supported residential settings in Ohio were offered HBPC. Individuals electing HBPC made up the intervention group. Those who did not opt for HBPC continued to receive traditional primary care services and made up the control group. Hospitalizations were tracked in both groups.
SETTING AND PARTICIPANTS


The 757 study participants had IDD diagnoses and received residential support services throughout the study period.
METHODS


Annualized hospitalization rate was determined in both groups and was compared using generalized estimating equations while controlling for patients' age and hospitalization rate in the year prior to the study.
RESULTS


The results showed that group membership had a significant effect on the hospitalization rate (Wald χ 2  = 20.71, P < .01). Being in the control group was associated with a 2.12-fold increase in annual hospitalization rate for a given patient. The overall population hospitalization rate was 329 hospitalizations per 1000 per year in the HBPC-receiving individuals and 619 hospitalizations per 1000 per year in the control group.
CONCLUSIONS AND IMPLICATIONS


We found that individuals with IDDs receiving HBPC were hospitalized at a lower rate than a control group receiving traditional primary care. Expanding access to HBPC may be a worthwhile priority for organizations that support individuals with IDDs.",2022,Being in the control group was associated with a 2.12-fold increase in annual hospitalization rate for a given patient.,"['individuals with IDDs receiving', 'Individuals With Intellectual and/or Developmental Disability', '757 study participants had IDD diagnoses and received residential support services throughout the study period', 'individuals with intellectual and/or developmental disabilities (IDDs', 'Individuals with IDDs living in supported residential settings in Ohio were offered HBPC']","['home-based primary care (HBPC', 'control group receiving traditional primary care', 'HBPC']","['overall population hospitalization rate', 'annual hospitalization rate', 'Annualized hospitalization rate', 'hospitalization rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",,0.0508168,Being in the control group was associated with a 2.12-fold increase in annual hospitalization rate for a given patient.,"[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Mills', 'Affiliation': 'BrightSpring Health Services, Louisville, KY, USA. Electronic address: William.Mills@brightspringhealth.com.'}, {'ForeName': 'Miranda M', 'Initials': 'MM', 'LastName': 'Huffman', 'Affiliation': 'BrightSpring Health Services, Louisville, KY, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Roosa', 'Affiliation': 'BrightSpring Health Services, Louisville, KY, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Pitzen', 'Affiliation': 'BrightSpring Health Services, Louisville, KY, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Boyd', 'Affiliation': 'BrightSpring Health Services, Louisville, KY, USA.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Schraer', 'Affiliation': 'BrightSpring Health Services, Louisville, KY, USA.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Poltavski', 'Affiliation': 'University of North Dakota, Grand Forks, ND, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2022.05.011']
2300,35715080,Pacing Optimized by Left Ventricular dP/dt max .,"Left ventricular (LV) dP/dt max  provides a sensitive measure of the acute hemodynamic response to cardiac resynchronization therapy (CRT) and can predict reverse remodeling on echocardiography. Its use to guide LV lead placement has been shown to improve outcomes in a multicenter randomized trial. Given the invasive protocol required for measurement, it is unlikely to be universally beneficial for patients undergoing CRT but may be useful for patients who do not respond to conventional CRT, or in those who have borderline indications or risk factors for non-response. In such cases, LV dP/dt max  may help guide LV lead placement, optimize device programming, and select the best alternative method of delivering CRT, such endocardial LV pacing or conduction system pacing.",2022,dt max  provides a sensitive measure of the acute hemodynamic response to cardiac resynchronization therapy (CRT) and can predict reverse remodeling on echocardiography.,[],['cardiac resynchronization therapy (CRT'],[],[],"[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}]",[],,0.0267761,dt max  provides a sensitive measure of the acute hemodynamic response to cardiac resynchronization therapy (CRT) and can predict reverse remodeling on echocardiography.,"[{'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Elliott', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK; Department of Cardiology, Guy's and St Thomas' NHS Foundation Trust, London, UK. Electronic address: mark.elliott@kcl.ac.uk.""}, {'ForeName': 'Vishal S', 'Initials': 'VS', 'LastName': 'Mehta', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK; Department of Cardiology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Rinaldi', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK; Department of Cardiology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}]",Cardiac electrophysiology clinics,['10.1016/j.ccep.2021.12.002']
2301,35715013,Effects of hypnosis versus enhanced standard of care on postoperative opioid use after total knee arthroplasty: the HYPNO-TKA randomized clinical trial.,"BACKGROUND


Hypnosis decreases perioperative pain and has opioid-sparing potential but has not been rigorously studied in knee arthroplasty. This trial investigates the impact of perioperative hypnosis on inpatient opioid use following total knee arthroplasty.
METHODS


This prospective randomized controlled trial was conducted at a single academic medical center. The hypnosis arm underwent a scripted 10 min hypnosis session prior to surgery and had access to the recorded script. The control arm received hypnosis education only. The primary outcome was opioid use in milligram oral morphine equivalents per 24 hours during hospital admission. A secondary analysis was performed for patients taking opioids preoperatively.
RESULTS


64 primary knee arthroplasty patients were randomized 1:1 to hypnosis (n=31) versus control (n=33) and included in the intent-to-treat analysis. The mean (SD) postoperative opioid use in oral morphine equivalents per 24 hours was 70.5 (48.4) in the hypnosis versus 90.7 (74.4) in the control arm, a difference that was not statistically significant (difference -20.1; 95% CI -51.8 to 11.4; p=0.20). In the subgroup analysis of the opioid-experienced patients, there was a 54% daily reduction in opioid use in the hypnosis group (82.4 (56.2) vs 179.1 (74.5) difference of -96.7; 95% CI -164.4 to -29.0; p=<0.01), equivalent to sparing 65 mg of oxycodone per day.
CONCLUSION


Perioperative hypnosis significantly reduced inpatient opioid use among opioid-experienced patients only. A larger study examining these findings is warranted.
TRIAL REGISTRATION NUMBER


NCT03308071.",2022,"In the subgroup analysis of the opioid-experienced patients, there was a 54% daily reduction in opioid use in the hypnosis group (82.4 (56.2) vs 179.1 (74.5) difference of -96.7","['total knee arthroplasty', '64 primary knee arthroplasty patients']","['oxycodone', 'hypnosis', 'perioperative hypnosis', 'scripted 10\u2009min hypnosis session prior to surgery and had access to the recorded script', 'hypnosis education only']","['mean (SD) postoperative opioid use in oral morphine equivalents', 'perioperative pain', 'opioid use in milligram oral morphine equivalents per 24 hours during hospital admission']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",64.0,0.231919,"In the subgroup analysis of the opioid-experienced patients, there was a 54% daily reduction in opioid use in the hypnosis group (82.4 (56.2) vs 179.1 (74.5) difference of -96.7","[{'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Markovits', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA jkittle@stanford.edu.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Blaha', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spiegel', 'Affiliation': 'Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2022-103493']
2302,35715011,Percutaneous auricular nerve stimulation (neuromodulation) for the treatment of pain following outpatient surgery: a proof-of-concept case series.,"BACKGROUND


Following outpatient surgery, it is often difficult to provide adequate analgesia while concurrently minimizing opioid requirements. Ultrasound-guided percutaneous peripheral nerve stimulation has been proposed as an analgesic, but requires physician-level skills, advanced equipment, up to an hour to administer, and is frequently cost prohibitive. In contrast, percutaneous auricular neuromodulation may be placed by nursing staff in a few minutes without additional equipment, theoretically provides analgesia for nearly any anatomic location, lacks systemic side effects, and has no significant risks. We now present a case report to demonstrate proof of concept for the off-label use of an auricular neuromodulation device-originally developed to treat symptoms associated with opioid withdrawal-to instead provide analgesia following outpatient surgery.
CASE PRESENTATION


Following moderately painful ambulatory orthopedic and breast surgery, seven patients had an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) affixed within the recovery room in approximately 5 min and discharged home. Average resting and dynamic pain scores measured on the 0-10 Numeric Rating Scale were a median of 1 over the first 2 days, subsequently falling to 0. Five patients avoided opioid use entirely, while the remaining two each consumed 5 mg of oxycodone during the first 1-2 postoperative days. After 5 days, the devices were removed at home and discarded.
CONCLUSIONS


These cases demonstrate that ambulatory percutaneous auricular neuromodulation is feasible and may be an effective analgesic and decreasing or even negating opioid requirements following outpatient surgery. Considering the lack of systemic side effects, serious adverse events, and misuse/dependence/diversion potential, further study with a randomized, controlled trial appears warranted.",2022,These cases demonstrate that ambulatory percutaneous auricular neuromodulation is feasible and may be an effective analgesic and decreasing or even negating opioid requirements following outpatient surgery.,"['pain following outpatient surgery', 'moderately painful ambulatory orthopedic and breast surgery, seven patients had an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) affixed within the recovery room in approximately 5\u2009min and discharged home']","['Percutaneous auricular nerve stimulation (neuromodulation', 'Ultrasound-guided percutaneous peripheral nerve stimulation', 'oxycodone']",['Average resting and dynamic pain scores'],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0730867,These cases demonstrate that ambulatory percutaneous auricular neuromodulation is feasible and may be an effective analgesic and decreasing or even negating opioid requirements following outpatient surgery.,"[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, La Jolla, California, USA bilfeld@health.ucsd.edu.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Finneran Iv', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dalstrom', 'Affiliation': 'Department of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Wallace', 'Affiliation': 'Department of Surgery, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Baharin', 'Initials': 'B', 'LastName': 'Abdullah', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Engy T', 'Initials': 'ET', 'LastName': 'Said', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, La Jolla, California, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2022-103777']
2303,35714910,Use of a Water Filter at Home Reduces Sugary Drink Consumption among Parents and Toddlers in Predominantly Hispanic Community: Results From the Water Up!@ Home Intervention Trial.,"BACKGROUND


Water is recommended as an alternative for sugar-sweetened beverages (SSB). Low-income, minority groups in the US continue to exhibit high SSB and low water consumption, and are more likely to exceed 100% fruit juice recommendation.
OBJECTIVE


To test the effects of a home-based intervention designed to replace SSB with tap water and reduce excess juice consumption among parents and their infants/toddlers.
DESIGN


Randomized Controlled Trial PARTICIPANTS: Parents (n=92) of infants/toddlers who participated in 3 Early Head Start (EHS) home-visiting programs that serve predominantly Hispanic, low-income communities 2019-2021.
INTERVENTION


The 12-week intervention (Water Up!@Home) simultaneously addressed: a) physical barriers to tap water consumption (via a water filter); b) sociocultural barriers to replacing SSB and juice with water (via a curriculum). Comparison group received a water filter only.
HYPOTHESIS


Intervention will lead to a reduction of 6 fl oz /day in SSB and juice consumption.
MAIN OUTCOMES


Parent-reported self and infant/toddler SSB; water (filtered, tap, bottled); 100% fruit juice consumption.
STATISTICAL ANALYSES


ANCOVA to compare changes in consumption between experimental groups; t-tests to assess changes within groups.
RESULTS


Participants in both groups reported significant reductions in SSB from baseline (parents: intervention [-11.2 fl oz/day, p<0.01]; comparison [-8.0 fl oz/day, p<0.01]; children: intervention [-1.50 fl oz/day, p=0.03]; comparison [-1.56 fl oz/day, p=0.02]), increased water consumption (parents in both groups [+5.6 fl oz/day]; children: intervention [+3.61 fl oz/day, p=0.01], comparison [+2.24 fl oz/day, p=0.05]), mostly from filtered tap water. Differences between groups were not statistically significant. Intervention participants reported significant reductions in 100% fruit juice vs. comparison (parents: -3.6 fl oz/day vs. -1.0 fl oz/day, p<0.01; children: -0.73 fl oz/day vs. +0.48 fl oz/day, p=0.03).
CONCLUSIONS


The intervention effectively reduced 100% fruit juice consumption. Water security should be examined as a contributor to SSB consumption in this population.",2022,Differences between groups were not statistically significant.,"[' Parents (n=92) of infants/toddlers who participated in 3 Early Head Start (EHS) home-visiting programs that serve predominantly Hispanic, low-income communities 2019-2021', 'Parents and Toddlers in Predominantly Hispanic Community', 'parents and their infants/toddlers']","['water filter only', 'intervention (Water Up!@Home) simultaneously addressed: a) physical barriers to tap water consumption (via a water filter); b) sociocultural barriers to replacing SSB and juice with water (via a curriculum', 'Water Filter at Home']","['SSB', 'increased water consumption', 'Sugary Drink Consumption']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C4045969', 'cui_str': 'Physical Barriers'}, {'cui': 'C2919405', 'cui_str': 'Tap water'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0750688,Differences between groups were not statistically significant.,"[{'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Reese', 'Affiliation': 'Candidate, Johns Hopkins University School of Medicine, 733 N Broadway, Baltimore, MD 21205.'}, {'ForeName': 'Rosalina', 'Initials': 'R', 'LastName': 'Burgos-Gil', 'Affiliation': 'Senior Director of Early Childhood Programs, CentroNia, 1420 Columbia Rd, Washington, DC, 20009.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Cleary', 'Affiliation': 'Associate Professor, Milken Institute School of Public Health, George Washington University, 950 New Hampshire Avenue, #511, Washington DC 20052.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Lora', 'Affiliation': 'Assistant Professor, Milken Institute School of Public Health, George Washington University, 950 New Hampshire Avenue, #214, Washington DC 20052.'}, {'ForeName': 'Ivonne', 'Initials': 'I', 'LastName': 'Rivera', 'Affiliation': 'President, Rivera Group, 8206 17(th) Avenue, Hyattsville, MD 20783.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Gittelsohn', 'Affiliation': 'Professor, Bloomberg School of Public Health, Johns Hopkins University, 615 N. Wolfe Street, Room W2041, Baltimore Maryland 21205.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Seper', 'Affiliation': 'Candidate, Milken Institute School of Public Health, George Washington University, 950 New Hampshire Avenue, Washington DC 20052.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Monge-Rojas', 'Affiliation': 'Costa Rican Institute for Research and Education on Nutrition and Health (INCIENSA), San Jose, Costa Rica.'}, {'ForeName': 'Uriyoán', 'Initials': 'U', 'LastName': 'Colón-Ramos', 'Affiliation': 'Associate Professor, Milken Institute School of Public Health, George Washington University, 950 New Hampshire Avenue, #410, Washington DC 20052.'}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2022.06.006']
2304,35715364,"Re: Øyvind Ulvik, Mathias Sørstrand Æsøy, Patrick Juliebø-Jones, Peder Gjengstø, Christian Beisland. Thulium Fibre Laser Versus Holmium:YAG for Ureteroscopic Lithotripsy: Outcomes from a Prospective Randomised Clinical Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2022.02.027: The Thulium Fibre Laser in Ureteroscopic Lithotripsy: Prospect and Risk Coexist?",,2022,,['Ureteroscopic Lithotripsy'],"['https://doi.org/10.1016/j.eururo.2022.02.027', 'Thulium Fibre Laser Versus Holmium:YAG']",[],"[{'cui': 'C0023878', 'cui_str': 'Lithotripsy'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0019846', 'cui_str': 'Holmium'}]",[],,0.0998895,,"[{'ForeName': 'Jinze', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China; West China School of Clinical Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China; West China School of Clinical Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Dehong', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China. Electronic address: weiqiang339@126.com.'}]",European urology,['10.1016/j.eururo.2022.05.017']
2305,35715198,Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial.,"OBJECTIVE


To investigate the safety and efficacy of normobaric hyperoxia (NBO) combined with endovascular treatment (EVT) in acute ischemic stroke (AIS) patients.
METHODS


In this single-center, proof-of-concept, assessor-blinded, randomized controlled pilot study, patients with AIS in the acute anterior circulation with large vessel occlusion who had an indication for EVT were randomly assigned to the EVT alone group or the NBO+EVT group. The NBO+EVT group were given 100% oxygen via a face mask initiated before vascular recanalization (10L/min for 4h) while the EVT group were given room air. The primary endpoint was infarct volume measured by MRI within 24-48 hours after randomization.
RESULTS


A total of 231 patients were screened and 86 patients were randomized 1:1 (EVT group, n=43; NBO+EVT group, n=43). The median infarction volume of the NBO+EVT group at 24-48h after randomization was significantly smaller than that of the EVT group (median 20.1 vs. 37.7 ml, p<0.01). The median mRS score at 90 days was 2 for NBO+EVT group as compared with 3 for EVT group [adjusted value 1.8, 95% CI 1.3-4.2; p = 0.038]. Compared with the EVT group, the NBO+ET group had a lower incidence of symptomatic intracranial hemorrhagic (7% vs. 12%), mortality (9% vs. 16%) and adverse events (33% vs. 42%); however, such a difference is not statistically significant.
CONCLUSION


NBO in combination with endovascular treatment appears to be a safe and feasible treatment strategy that could significantly reduce infarct volume, improve short-term neurobehavioral test score, and enhance clinical outcomes at 90 days compared with endovascular treatment alone in AIS patients. These observations need to be further confirmed by a large multicenter, randomized clinical trial.
CLASSIFICATION OF EVIDENCE


This pilot study provides Class I evidence that normobaric hyperoxia combined with standard endovascular treatment decreases infarction volume in patients with acute anterior circulation stroke.
CLINICALTRIALS


gov identifier NCT03620370.",2022,"The median mRS score at 90 days was 2 for NBO+EVT group as compared with 3 for EVT group [adjusted value 1.8, 95% CI 1.3-4.2; p = 0.038].","['patients with acute anterior circulation stroke', 'Acute Ischemic Stroke Patients', '231 patients were screened and 86 patients were randomized 1:1 (EVT group, n=43; NBO+EVT group, n=43', 'acute ischemic stroke (AIS) patients', 'patients with AIS in the acute anterior circulation with large vessel occlusion who had an indication for EVT']","['Normobaric Hyperoxia Combined With Endovascular Treatment', '100% oxygen via a face mask initiated before vascular recanalization (10L/min for 4h) while the EVT group were given room air', 'normobaric hyperoxia (NBO) combined with endovascular treatment (EVT', 'EVT alone group or the NBO+EVT', 'NBO+ET', 'normobaric hyperoxia combined with standard endovascular treatment', 'EVT']","['adverse events', 'infarct volume measured by MRI', 'median mRS score', 'infarct volume, improve short-term neurobehavioral test score', 'infarction volume', 'median infarction volume', 'symptomatic intracranial hemorrhagic', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",231.0,0.0895903,"The median mRS score at 90 days was 2 for NBO+EVT group as compared with 3 for EVT group [adjusted value 1.8, 95% CI 1.3-4.2; p = 0.038].","[{'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Cerebrovascular Diseases Research Institute, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'Cerebrovascular Diseases Research Institute, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qingfeng', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiayue', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Chuanjie', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Emergency, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'School of Statistics, University of Minnesota at Twin Cities, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Huining', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Longfei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Kangxiang', 'Initials': 'K', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China jixm@ccmu.edu.cn.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Chuanhui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Emergency, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Chenghe', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'Xunming', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Cerebrovascular Diseases Research Institute, Xuanwu Hospital, Capital Medical University, Beijing, China jixm@ccmu.edu.cn.'}, {'ForeName': 'Ke Jian', 'Initials': 'KJ', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmaceutical Sciences, University of New Mexico Health Sciences Center, Albuquerque, NM 87131, USA.'}]",Neurology,['10.1212/WNL.0000000000200775']
2306,35715184,"Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial.","INTRODUCTION


Infertility is a common complication of endometriosis. While in vitro fertilisation-embryo transfer (IVF) successfully treats endometriosis-associated infertility, there is some evidence that pregnancy rates may be diminished in women seeing fertility treatment for endometriosis-associated infertility compared with other etiologies of infertility. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF has been suggested to improve success, however studies have been small and rarely reported live birth rates. Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility.
METHODS AND ANALYSIS


This study is a multicentre, prospective, randomised, double-blind, placebo-controlled trial to study the efficacy of GnRH antagonist pretreatment for women with endometriosis who are undergoing IVF. A total of 814 patients with endometriosis undergoing fertility treatment will be enrolled and randomised 1:1 into two groups: elagolix 200 mg two times per day or placebo for 8 weeks, prior to undergoing IVF. All participants will then undergo IVF treatment per local protocols. The primary outcome is live birth. Secondary outcomes include oocyte number, fertilisation rate, embryo morphology and implantation rates, as well as rates of known endometriosis-related obstetrical outcomes (pregnancy-induced hypertension, antepartum haemorrhage, caesarean delivery and preterm birth).
ETHICS AND DISSEMINATION


The PREGnant trial was approved by the Institutional Review Board at Johns Hopkins University. Results will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT04173169.",2022,"Secondary outcomes include oocyte number, fertilisation rate, embryo morphology and implantation rates, as well as rates of known endometriosis-related obstetrical outcomes (pregnancy-induced hypertension, antepartum haemorrhage, caesarean delivery and preterm birth).
","['women with endometriosis', 'women with endometriosis who are undergoing IVF', '814 patients with endometriosis undergoing fertility treatment']","['oral GnRH antagonist', 'GnRH antagonist pretreatment', 'GnRH antagonists', 'elagolix 200\u2009mg two times per day or placebo', 'vitro fertilisation-embryo transfer (IVF', 'gonadotropin releasing hormone (GnRH) agonist prior to IVF', 'Pre-IVF treatment with a GnRH antagonist', 'placebo']","['live birth', 'oocyte number, fertilisation rate, embryo morphology and implantation rates, as well as rates of known endometriosis-related obstetrical outcomes (pregnancy-induced hypertension, antepartum haemorrhage, caesarean delivery and preterm birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C4704604', 'cui_str': 'elagolix 200 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0852036', 'cui_str': 'Pregnancy-induced hypertension'}, {'cui': 'C0269608', 'cui_str': 'Antepartum hemorrhage'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",814.0,0.641788,"Secondary outcomes include oocyte number, fertilisation rate, embryo morphology and implantation rates, as well as rates of known endometriosis-related obstetrical outcomes (pregnancy-induced hypertension, antepartum haemorrhage, caesarean delivery and preterm birth).
","[{'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USA hugh.taylor@yale.edu.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Carson', 'Affiliation': 'Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Flores', 'Affiliation': 'Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Pal', 'Affiliation': 'Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Robbins', 'Affiliation': 'Obstetrics and Gynecology, Northwestern University, Evanston, Chicago, USA.'}, {'ForeName': 'Nanette F', 'Initials': 'NF', 'LastName': 'Santoro', 'Affiliation': 'Obstetrics and Gynecology, University of Colorado, Denver, Colorado, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Segars', 'Affiliation': 'Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Seifer', 'Affiliation': 'Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Biostatistics, Yale University School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Obstetrics and Gynecology, The University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Biostatistics, Yale University School of Public Health, New Haven, Connecticut, USA.'}]",BMJ open,['10.1136/bmjopen-2021-052043']
2307,35715180,Protocol for process evaluation of SMART Mental Health cluster randomised control trial: an intervention for management of common mental disorders in India.,"INTRODUCTION


In India about 95% of individuals who need treatment for common mental disorders like depression, stress and anxiety and substance use are unable to access care. Stigma associated with help seeking and lack of trained mental health professionals are important barriers in accessing mental healthcare. Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health integrates a community-level stigma reduction campaign and task sharing with the help of a mobile-enabled electronic decision support system (EDSS)-to reduce psychiatric morbidity due to stress, depression and self-harm in high-risk individuals. This paper presents and discusses the protocol for process evaluation of SMART Mental Health.
METHODS AND ANALYSIS


The process evaluation will use mixed quantitative and qualitative methods to evaluate implementation fidelity and identify facilitators of and barriers to implementation of the intervention. Case studies of six intervention and two control clusters will be used. Quantitative data sources will include usage analytics extracted from the mHealth platform for the trial. Qualitative data sources will include focus group discussions and interviews with recruited participants, primary health centre doctors, community health workers (Accredited Social Health Activits) who participated in the project and local community leaders. The design and analysis will be guided by Medical Research Council framework for process evaluations, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, and the normalisation process theory.
ETHICS AND DISSEMINATION


The study has been approved by the ethics committee of the George Institute for Global Health, India and the Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi. Findings of the study will be disseminated through peer-reviewed publications, stakeholder meetings, digital and social media platforms.
TRIAL REGISTRATION NUMBER


CTRI/2018/08/015355.",2022,"Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health integrates a community-level stigma reduction campaign and task sharing with the help of a mobile-enabled electronic decision support system (EDSS)-to reduce psychiatric morbidity due to stress, depression and self-harm in high-risk individuals.","['recruited participants, primary health centre doctors, community health workers (Accredited Social Health Activits) who participated in the project and local community leaders', 'common mental disorders in India']",[],[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0021201', 'cui_str': 'India'}]",[],[],,0.0866259,"Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health integrates a community-level stigma reduction campaign and task sharing with the help of a mobile-enabled electronic decision support system (EDSS)-to reduce psychiatric morbidity due to stress, depression and self-harm in high-risk individuals.","[{'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Mercian', 'Initials': 'M', 'LastName': 'Daniel', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Sudha', 'Initials': 'S', 'LastName': 'Kallakuri', 'Affiliation': 'The George Institute for Global Health, Hyderabad, India.'}, {'ForeName': 'Amanpreet', 'Initials': 'A', 'LastName': 'Kaur', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Siddhardha', 'Initials': 'S', 'LastName': 'Devarapalli', 'Affiliation': 'The George Institute for Global Health, Hyderabad, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Raman', 'Affiliation': 'Department of Communication, University of Hyderabad, Hyderabad, India.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""Centre for Global Mental Health Centre for Implementation Science, Health Service and Population Research Department, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Beverley M', 'Initials': 'BM', 'LastName': 'Essue', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Praveen', 'Affiliation': 'The George Institute for Global Health, Hyderabad, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sagar', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shashi', 'Initials': 'S', 'LastName': 'Kant', 'Affiliation': 'Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shekhar', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': 'Department of Global Health and Population, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, SydneyAustralia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peiris', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, SydneyAustralia.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'The George Institute for Global Health, New Delhi, India pmaulik@georgeinstitute.org.in.'}]",BMJ open,['10.1136/bmjopen-2021-058669']
2308,35715644,Astodrimer sodium antiviral nasal spray for reducing respiratory infections is safe and well tolerated in a randomized controlled trial.,"Astodrimer sodium is a dendrimer molecule with antiviral and virucidal activity against SARS-CoV-2 and other respiratory viruses in vitro, and has previously been shown to be safe and well tolerated, and not systemically absorbed, when applied to the vaginal mucosa. To investigate its potential utility as a topical antiviral, astodrimer sodium has been reformulated for application to the nasal mucosa to help reduce viral load before or after exposure to respiratory infection. The current investigation assessed the safety, tolerability and absorption of astodrimer sodium 1% antiviral nasal spray. This was a single-centre, double-blinded, randomized, placebo-controlled, exploratory clinical investigation. Forty healthy volunteers aged 18 to 65 years with no clinically significant nasal cavity examination findings were randomized 3:1 to astodrimer sodium nasal spray (N = 30) or placebo (N = 10) at an Australian clinical trials facility. An initial cohort of participants (N = 12 astodrimer, N = 4 placebo) received a single application (one spray per nostril) to assess any acute effects, followed by a washout period, before self-administering the spray four times daily for 14 days to represent an intensive application schedule. Extent of absorption of astodrimer sodium via the nasal mucosa was also assessed in this cohort. A second cohort of participants (N = 18 astodrimer, N = 6 placebo) self-administered the spray four times daily for 14 days. The primary endpoint was safety, measured by frequency and severity of treatment emergent adverse events (TEAEs), including clinically significant nasal cavity examination findings, in the safety population (all participants randomized who administered any spray). Participants were randomized between 6 January 2021 and 29 March 2021. TEAEs occurred in 8/10 (80%) participants in the placebo arm and 19/30 (63.3%) participants in the astodrimer sodium arm; all were of mild intensity. TEAEs considered potentially related to study product occurred in 5/10 (50%) participants receiving placebo and 10/30 (33.3%) of participants receiving astodrimer sodium. No participants experienced serious AEs, or TEAEs leading to withdrawal from the study. No systemic absorption of astodrimer sodium via the nasal mucosa was detected. Astodrimer sodium nasal spray was well tolerated and is a promising innovation warranting further investigation for nasal administration to potentially reduce infection and spread of community acquired respiratory virus infections.Trial Registration: ACTRN12620001371987, first registered 22-12-2020 (Australia New Zealand Clinical Trials Registry, https://anzctr.org.au/ ).",2022,Astodrimer sodium nasal spray was well tolerated and is a promising innovation warranting further investigation for nasal administration to potentially reduce infection and spread of community acquired respiratory virus infections.,"['Forty healthy volunteers aged 18 to 65\xa0years with no clinically significant nasal cavity examination findings', 'Participants were randomized between 6 January 2021 and 29 March 2021', 'participants (N\u2009=\u200918 astodrimer, N\u2009=\u20096']","['astodrimer sodium nasal spray (N\u2009=\u200930) or placebo', 'single application (one spray per nostril', 'placebo) self-administered the spray', 'astodrimer sodium 1% antiviral nasal spray', 'Astodrimer sodium', 'Astodrimer sodium nasal spray', 'Astodrimer sodium antiviral nasal spray', 'placebo']","['safety, measured by frequency and severity of treatment emergent adverse events (TEAEs), including clinically significant nasal cavity examination findings', 'safety, tolerability and absorption']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0438105', 'cui_str': 'Examination finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0438105', 'cui_str': 'Examination finding'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",40.0,0.490251,Astodrimer sodium nasal spray was well tolerated and is a promising innovation warranting further investigation for nasal administration to potentially reduce infection and spread of community acquired respiratory virus infections.,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Castellarnau', 'Affiliation': 'Starpharma Pty Ltd, 4-6 Southampton Crescent, Abbotsford, VIC, 3067, Australia.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Heery', 'Affiliation': 'Starpharma Pty Ltd, 4-6 Southampton Crescent, Abbotsford, VIC, 3067, Australia.'}, {'ForeName': 'Aynaz', 'Initials': 'A', 'LastName': 'Seta', 'Affiliation': 'Starpharma Pty Ltd, 4-6 Southampton Crescent, Abbotsford, VIC, 3067, Australia.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Luscombe', 'Affiliation': 'Starpharma Pty Ltd, 4-6 Southampton Crescent, Abbotsford, VIC, 3067, Australia.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Kinghorn', 'Affiliation': 'University of Sheffield, Sheffield, S10 2TN, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Button', 'Affiliation': 'McCloud Consulting Group Pty Ltd, Belrose, NSW, 2085, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McCloud', 'Affiliation': 'McCloud Consulting Group Pty Ltd, Belrose, NSW, 2085, Australia.'}, {'ForeName': 'Jeremy R A', 'Initials': 'JRA', 'LastName': 'Paull', 'Affiliation': 'Starpharma Pty Ltd, 4-6 Southampton Crescent, Abbotsford, VIC, 3067, Australia. jeremy.paull@starpharma.com.'}]",Scientific reports,['10.1038/s41598-022-14601-3']
2309,35715625,Sex differences in central insulin action: Effect of intranasal insulin on neural food cue reactivity in adults with normal weight and overweight.,"BACKGROUND/OBJECTIVES


Central insulin action influences cognitive processes, peripheral metabolism, and eating behavior. However, the contribution of obesity and sex on central insulin-mediated neural food cue processing still remains unclear.
SUBJECTS/METHODS


In a randomized within-participant design, including two visits, 60 participants (30 women, BMI 18-32 kg/m 2 , age 21-69 years) underwent a functional MRI task measuring blood oxygen level-dependent (BOLD) signal in response to visual food cues after intranasal insulin or placebo spray administration. Central insulin action was defined as the neural BOLD response to food cues after insulin compared to placebo administration. Afterwards, participants were asked to rate the food cues for desire to eat (i.e., wanting rating). For statistical analyses, participants were grouped according to BMI and sex.
RESULTS


Food cue reactivity in the amygdala showed higher BOLD activation in response to central insulin compared to placebo. Furthermore, women with overweight and obesity and men of normal weight showed higher BOLD neural food cue responsivity to central insulin compared to placebo. Higher central insulin action in the insular cortex was associated with better peripheral insulin sensitivity and higher cognitive control. Moreover, central insulin action in the dorsolateral prefrontal cortex (DLPFC) revealed significant sex differences. In response to central insulin compared to placebo, men showed lower DLPFC BOLD activity, whereas women showed higher DLPFC activity in response to highly desired food cues. On behavioral level, central insulin action significantly reduced hunger, whereas the desire to eat, especially for low caloric food cues was significantly higher with central insulin than with placebo.
CONCLUSIONS


Obesity and sex influenced the central insulin-mediated neural BOLD activity to visual food cues in brain regions implicated in reward and cognitive control. These findings show that central insulin action regulates food response differentially in men and women, which may have consequences for metabolism and eating behavior.",2022,"In response to central insulin compared to placebo, men showed lower DLPFC BOLD activity, whereas women showed higher DLPFC activity in response to highly desired food cues.","['adults with normal weight and overweight', '60 participants (30 women, BMI 18-32\u2009kg/m 2 , age 21-69 years) underwent a', 'women with overweight and obesity and men of normal weight']","['functional MRI task measuring blood oxygen level-dependent (BOLD) signal in response to visual food cues after intranasal insulin or placebo spray administration', 'intranasal insulin', 'placebo', 'central insulin action']","['DLPFC activity', 'DLPFC BOLD activity', 'BOLD activation', 'low caloric food cues', 'peripheral insulin sensitivity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.166828,"In response to central insulin compared to placebo, men showed lower DLPFC BOLD activity, whereas women showed higher DLPFC activity in response to highly desired food cues.","[{'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Wagner', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany. Lore.wagner@uni-tuebingen.de.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Veit', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Fritsche', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Häring', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fritsche', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heni', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Preissl', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kullmann', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany.'}]",International journal of obesity (2005),['10.1038/s41366-022-01167-3']
2310,35715574,Improving Swallowing Function and Ability in Post Stroke Dysphagia: A Randomized Clinical Trial.,"Post-stroke dysphagia is a prevalent, life threatening condition. Scientists recommended implementing behavioral therapies with new technologies such as transcranial direct current of stimulation (TDCS). Studies showed promising TDCS effects, and scientists suggested the investigation of the effectiveness of different montages. Supramarginal gyrus (SMG) is important in swallowing function. Our study aimed to investigate the effectiveness of stimulating SMG in improving post-stroke dysphagia. Forty-four patients finished the study (a randomized, double-blind one). All of them received behavioral therapy. The real group received anodal (2 mA, 20 min) stimulation on the intact SMG, and the sham group received the same for 30 s (5 sessions). Patients were assessed with Functional Oral Intake Scale (FOIS) and Mann Assessment of Swallowing Ability (MASA) after treatment and at one-month follow-up. The results showed that the difference between groups at baseline was not significant. According to MASA both groups improved significantly during the time (p-value < 0.001). The improvement in the real group was significantly higher than in the sham group after treatment (p-value = 0.002) and after one-month follow-up (p-value < 0.001). According to FOIS, most of the patients in the real group (72.70%) reached level 6 or 7 after one-month follow-up which was significantly higher than the sham group (31.80%, p-value = 0.007). In conclusion, TDCS applied to the scalp's surface associated with SMG localization may improve swallowing function in the stroke patients with dysphagia.",2022,The improvement in the real group was significantly higher than in the sham group after treatment (p-value = 0.002) and after one-month follow-up (p-value < 0.001).,"['stroke patients with dysphagia', 'Post Stroke Dysphagia']","['MASA', 'TDCS', 'anodal (2\xa0mA, 20\xa0min) stimulation on the intact SMG', 'behavioral therapy', 'stimulating SMG']","['Functional Oral Intake Scale (FOIS) and Mann Assessment of Swallowing Ability (MASA', 'swallowing function']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0228214', 'cui_str': 'Structure of supramarginal gyrus'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",44.0,0.159275,The improvement in the real group was significantly higher than in the sham group after treatment (p-value = 0.002) and after one-month follow-up (p-value < 0.001).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Farpour', 'Affiliation': 'Neuroscience Research Center, Neuropharmacology Institute, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Asadi-Shekaari', 'Affiliation': 'Neuroscience Research Center, Neuropharmacology Institute, Kerman University of Medical Sciences, Kerman, Iran. majidasadi@kmu.ac.ir.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Borhani Haghighi', 'Affiliation': 'Faculty of Medicine, Clinical Neurology Research Center, Shiraz University of Medical Sciences, Khalili Street, Shiraz, Iran. neuro.ab@gmail.com.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Farpour', 'Affiliation': 'Faculty of Medicine, Bone and Joint Diseases Research Center, Department of Physical Medicine and Rehabilitation, Shiraz University of Medical Sciences, Emam Hossein Street, Shiraz, Iran.'}]",Dysphagia,['10.1007/s00455-022-10470-0']
2311,35715567,Onasemnogene abeparvovec for presymptomatic infants with three copies of SMN2 at risk for spinal muscular atrophy: the Phase III SPR1NT trial.,"Most children with biallelic SMN1 deletions and three SMN2 copies develop spinal muscular atrophy (SMA) type 2. SPR1NT ( NCT03505099 ), a Phase III, multicenter, single-arm trial, investigated the efficacy and safety of onasemnogene abeparvovec for presymptomatic children with biallelic SMN1 mutations treated within six postnatal weeks. Of 15 children with three SMN2 copies treated before symptom onset, all stood independently before 24 months (P < 0.0001; 14 within normal developmental window), and 14 walked independently (P < 0.0001; 11 within normal developmental window). All survived without permanent ventilation at 14 months; ten (67%) maintained body weight (≥3rd WHO percentile) without feeding support through 24 months; and none required nutritional or respiratory support. No serious adverse events were considered treatment-related by the investigator. Onasemnogene abeparvovec was effective and well-tolerated for presymptomatic infants at risk of SMA type 2, underscoring the urgency of early identification and intervention.",2022,No serious adverse events were considered treatment-related by the investigator.,"['presymptomatic infants with three copies of SMN2 at risk for spinal muscular atrophy', 'presymptomatic children with biallelic SMN1 mutations treated within six postnatal weeks']",['SPR1NT'],"['efficacy and safety', 'effective and well-tolerated', 'serious adverse events']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0439230', 'cui_str': 'week'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",15.0,0.0211708,No serious adverse events were considered treatment-related by the investigator.,"[{'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Strauss', 'Affiliation': 'Clinic for Special Children, Strasburg, PA, USA. kstrauss@clinicforspecialchildren.org.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Farrar', 'Affiliation': ""Department of Neurology, Sydney Children's Hospital Network, Sydney, NSW, Australia.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Muntoni', 'Affiliation': 'The Dubowitz Neuromuscular Centre, University College London, Great Ormond Street Institute of Child Health & Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': ""Institute of Medical Genetics, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Mendell', 'Affiliation': ""Center for Gene Therapy, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Servais', 'Affiliation': 'Department of Paediatrics, MDUK Oxford Neuromuscular Centre, Oxford, UK.'}, {'ForeName': 'Hugh J', 'Initials': 'HJ', 'LastName': 'McMillan', 'Affiliation': ""Department of Pediatrics, Neurology & Neurosurgery, Montreal Children's Hospital, McGill University, Montreal, QC, Canada.""}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finkel', 'Affiliation': ""Department of Pediatrics, Nemours Children's Hospital, Orlando, FL, USA.""}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Swoboda', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Zaidman', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Claudia A', 'Initials': 'CA', 'LastName': 'Chiriboga', 'Affiliation': 'Division of Pediatric Neurology, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Iannaccone', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Jena M', 'Initials': 'JM', 'LastName': 'Krueger', 'Affiliation': ""Department of Neurology, Helen DeVos Children's Hospital, Grand Rapids, MI, USA.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Parsons', 'Affiliation': 'Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Perry B', 'Initials': 'PB', 'LastName': 'Shieh', 'Affiliation': 'Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kavanagh', 'Affiliation': 'Novartis Gene Therapies, Inc., Bannockburn, IL, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wigderson', 'Affiliation': 'Novartis Gene Therapies, Inc., Bannockburn, IL, USA.'}, {'ForeName': 'Sitra', 'Initials': 'S', 'LastName': 'Tauscher-Wisniewski', 'Affiliation': 'Novartis Gene Therapies, Inc., Bannockburn, IL, USA.'}, {'ForeName': 'Bryan E', 'Initials': 'BE', 'LastName': 'McGill', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Macek', 'Affiliation': 'Novartis Gene Therapies, Inc., Bannockburn, IL, USA.'}]",Nature medicine,['10.1038/s41591-022-01867-3']
2312,35715486,Daily mother-infant skin-to-skin contact and maternal mental health and postpartum healing: a randomized controlled trial.,"This randomized controlled trial examined the effects of a daily hour of mother-infant skin-to-skin contact (SSC) during the first five postnatal weeks, compared to care-as-usual, on maternal depressive (primary outcome), anxiety, stress, fatigue, pain, and delivery-related post-traumatic stress symptoms (PTSS). Prenatal symptom severity and touch discomfort were examined as moderators. Mothers and full-term infants were randomly allocated to SSC or care-as-usual conditions and followed during the first postnatal year. For the total group (intention-to-treat analyses), care-as-usual mothers showed an increase of anxiety symptoms from week 2 to 12, while SSC mothers displayed a stability of anxiety symptoms. Also, care-as-usual mothers showed an initial decrease in fatigue followed by an increase, while SSC mothers showed a decrease from week 2 to 12. In per-protocol analyses, including only the SSC dyads who adhered to SSC guidelines, findings on anxiety, but not fatigue, were replicated. No SSC effects were found for depressive, stress, and pain symptoms. No moderator, dose-response, or 52-week follow-up effects were found. PTSS were low with little variation; consequently, analyses were discontinued. Daily SSC in healthy mother-infant dyads may reduce anxiety and fatigue symptoms, but not depressive, stress, and pain symptoms, during the early postpartum period. Replication studies are recommended.",2022,"No SSC effects were found for depressive, stress, and pain symptoms.","['Mothers and full-term infants', 'Daily mother-infant skin-to-skin contact and maternal mental health and postpartum healing', 'healthy mother-infant dyads']",['daily hour of mother-infant skin-to-skin contact (SSC'],"['fatigue', 'depressive, stress, and pain symptoms', 'anxiety symptoms', 'maternal depressive (primary outcome), anxiety, stress, fatigue, pain, and delivery-related post-traumatic stress symptoms (PTSS', 'anxiety and fatigue symptoms', 'stability of anxiety symptoms', 'Prenatal symptom severity and touch discomfort']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0282942,"No SSC effects were found for depressive, stress, and pain symptoms.","[{'ForeName': 'Kelly H M', 'Initials': 'KHM', 'LastName': 'Cooijmans', 'Affiliation': 'Department of Developmental Psychology, Behavioural Science Institute, Radboud University, Thomas van Aquinostraat 4, 6525 GD, Nijmegen, The Netherlands. kelly.cooijmans@radboudumc.nl.'}, {'ForeName': 'Roseriet', 'Initials': 'R', 'LastName': 'Beijers', 'Affiliation': 'Department of Developmental Psychology, Behavioural Science Institute, Radboud University, Thomas van Aquinostraat 4, 6525 GD, Nijmegen, The Netherlands.'}, {'ForeName': 'Bonnie E', 'Initials': 'BE', 'LastName': 'Brett', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition, and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'de Weerth', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition, and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-022-14148-3']
2313,35715460,Non-invasive vagus nerve stimulation in epilepsy patients enhances cooperative behavior in the prisoner's dilemma task.,"The vagus nerve constitutes a key link between the autonomic and the central nervous system. Previous studies provide evidence for the impact of vagal activity on distinct cognitive processes including functions related to social cognition. Recent studies in animals and humans show that vagus nerve stimulation is associated with enhanced reward-seeking and dopamine-release in the brain. Social interaction recruits similar brain circuits to reward processing. We hypothesize that vagus nerve stimulation (VNS) boosts rewarding aspects of social behavior and compare the impact of transcutaneous VNS (tVNS) and sham stimulation on social interaction in 19 epilepsy patients in a double-blind pseudo-randomized study with cross-over design. Using a well-established paradigm, i.e., the prisoner's dilemma, we investigate effects of stimulation on cooperative behavior, as well as interactions of stimulation effects with patient characteristics. A repeated-measures ANOVA and a linear mixed-effects model provide converging evidence that tVNS boosts cooperation. Post-hoc correlations reveal that this effect varies as a function of neuroticism, a personality trait linked to the dopaminergic system. Behavioral modeling indicates that tVNS induces a behavioral starting bias towards cooperation, which is independent of the decision process. This study provides evidence for the causal influence of vagus nerve activity on social interaction.",2022,Recent studies in animals and humans show that vagus nerve stimulation is associated with enhanced reward-seeking and dopamine-release in the brain.,"['epilepsy patients', '19 epilepsy patients']","['vagus nerve stimulation (VNS', 'transcutaneous VNS (tVNS) and sham stimulation']",[],"[{'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],19.0,0.0506434,Recent studies in animals and humans show that vagus nerve stimulation is associated with enhanced reward-seeking and dopamine-release in the brain.,"[{'ForeName': 'Carina R', 'Initials': 'CR', 'LastName': 'Oehrn', 'Affiliation': 'Department of Neurology, Philipps-University Marburg, Marburg, Germany. carina.oehrn@staff.uni-marburg.de.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Molitor', 'Affiliation': 'Department of Neurology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Krause', 'Affiliation': 'Department of Neurology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Hauke', 'Initials': 'H', 'LastName': 'Niehaus', 'Affiliation': 'Department of Psychology, Theoretical Neuroscience Section, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schmidt', 'Affiliation': 'Department of Neurology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hakel', 'Affiliation': 'Department of Neurology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Timmermann', 'Affiliation': 'Department of Neurology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Menzler', 'Affiliation': 'Department of Neurology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Knake', 'Affiliation': 'Department of Neurology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Immo', 'Initials': 'I', 'LastName': 'Weber', 'Affiliation': 'Department of Neurology, Philipps-University Marburg, Marburg, Germany.'}]",Scientific reports,['10.1038/s41598-022-14237-3']
2314,35711442,Vaccination With Oral Polio Vaccine Reduces COVID-19 Incidence.,"Background


Effective response to emerging pandemic threats is complicated by the need to develop specific vaccines and other medical products. The availability of broadly specific countermeasures that could be deployed early in the pandemic could significantly alter its course and save countless lives. Live attenuated vaccines (LAVs) were shown to induce non-specific protection against a broad spectrum of off-target pathogens by stimulating innate immune responses. The purpose of this study was to evaluate the effect of immunization with bivalent Oral Poliovirus Vaccine (bOPV) on the incidence of COVID-19 and other acute respiratory infections (ARIs).
Methods and Findings


A randomized parallel-group comparative study was conducted in Kirov Medical University. 1115 healthy volunteers aged 18 to 65 were randomized into two equal groups, one of which was immunized orally with a single dose of bOPV ""BiVac Polio"" and another with placebo. The study participants were monitored for three months for respiratory illnesses including COVID-19. The endpoint was the incidence of acute respiratory infections and laboratory confirmed COVID-19 in both groups during 3 months after immunization. The number of laboratory-confirmed cases of COVID-19 was significantly lower in the vaccinated group than in placebo (25 cases vs. 44, p=0.036). The difference between the overall number of clinically diagnosed respiratory illnesses in the two groups was not statistically significant.
Conclusions


Immunization with bOPV reduced the number of laboratory-confirmed COVID-19 cases, consistent with the original hypothesis that LAVs induce non-specific protection against off-target infections. The findings are in line with previous observations of the protective effects of OPV against seasonal influenza and other viral and bacterial pathogens. The absence of a statistically significant effect on the total number of ARIs may be due to the insufficient number of participants and heterogeneous etiology of ARIs. OPV could be used to complement specific coronavirus vaccines, especially in regions of the world where the vaccines are unavailable, and as a stopgap measure for urgent response to future emerging infections. Clinical trial registration number NCT05083039 at clinicaltrals.gov https://clinicaltrials.gov/ct2/show/NCT05083039?term=NCT05083039&draw=2&rank=1.",2022,Live attenuated vaccines (LAVs) were shown to induce non-specific protection against a broad spectrum of off-target pathogens by stimulating innate immune responses.,"['1115 healthy volunteers aged 18 to 65', 'Kirov Medical University']","['Oral Polio Vaccine', 'bOPV ""BiVac Polio"" and another with placebo', 'Live attenuated vaccines (LAVs', 'bivalent Oral Poliovirus Vaccine (bOPV', 'placebo']","['overall number of clinically diagnosed respiratory illnesses', 'total number of ARIs', 'COVID-19 Incidence', 'incidence of acute respiratory infections and laboratory confirmed COVID-19', 'number of laboratory-confirmed cases of COVID-19']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",1115.0,0.236914,Live attenuated vaccines (LAVs) were shown to induce non-specific protection against a broad spectrum of off-target pathogens by stimulating innate immune responses.,"[{'ForeName': 'Nadezhda V', 'Initials': 'NV', 'LastName': 'Yagovkina', 'Affiliation': 'Center for Clinical Trials, Kirov State Medical University, Russian Ministry of Health, Kirov, Russia.'}, {'ForeName': 'Lev M', 'Initials': 'LM', 'LastName': 'Zheleznov', 'Affiliation': 'Center for Clinical Trials, Kirov State Medical University, Russian Ministry of Health, Kirov, Russia.'}, {'ForeName': 'Ksenia A', 'Initials': 'KA', 'LastName': 'Subbotina', 'Affiliation': 'Department of Epidemiology, Perm State Medical University, Ministry of Health, Perm, Russia.'}, {'ForeName': 'Andrey A', 'Initials': 'AA', 'LastName': 'Tsaan', 'Affiliation': 'RIC-Pharma, Moscow, Russia.'}, {'ForeName': 'Liubov I', 'Initials': 'LI', 'LastName': 'Kozlovskaya', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Ilya V', 'Initials': 'IV', 'LastName': 'Gordeychuk', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Anastasia K', 'Initials': 'AK', 'LastName': 'Korduban', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Yury Y', 'Initials': 'YY', 'LastName': 'Ivin', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Anastasia A', 'Initials': 'AA', 'LastName': 'Kovpak', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Anastasia N', 'Initials': 'AN', 'LastName': 'Piniaeva', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Anna A', 'Initials': 'AA', 'LastName': 'Shishova', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Elena Y', 'Initials': 'EY', 'LastName': 'Shustova', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Yusuf K', 'Initials': 'YK', 'LastName': 'Khapchaev', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Galina G', 'Initials': 'GG', 'LastName': 'Karganova', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Alexandra A', 'Initials': 'AA', 'LastName': 'Siniugina', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Tatiana V', 'Initials': 'TV', 'LastName': 'Pomaskina', 'Affiliation': 'Biopolis-Kirov 200 Subsidiary of Chumakov Center for Research and Development of Immunobiological Products, Kirov, Russia.'}, {'ForeName': 'Aleksandr A', 'Initials': 'AA', 'LastName': 'Erovichenkov', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Chumakov', 'Affiliation': 'U.S. Food and Drug Administraion (FDA) Office of Vaccines Research and Review, Global Virus Network Center of Excellence, Silver Spring, MD, United States.'}, {'ForeName': 'Aydar A', 'Initials': 'AA', 'LastName': 'Ishmukhametov', 'Affiliation': 'Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Global Virus Network Center of Excellence, Moscow, Russia.'}]",Frontiers in immunology,['10.3389/fimmu.2022.907341']
2315,35711313,Morning Exercise Reduces Abdominal Fat and Blood Pressure in Women; Evening Exercise Increases Muscular Performance in Women and Lowers Blood Pressure in Men.,"The ideal exercise time of day (ETOD) remains elusive regarding simultaneous effects on health and performance outcomes, especially in women.  Purpose:  Given known sex differences in response to exercise training, this study quantified health and performance outcomes in separate cohorts of women and men adhering to different ETOD.  Methods:  Thirty exercise-trained women (BMI = 24 ± 3 kg/m 2 ; 42 ± 8 years) and twenty-six men (BMI = 25.5 ± 3 kg/m 2 ; 45 ± 8 years) were randomized to multimodal ETOD in the morning (0600-0800 h, AM) or evening (1830-2030 h, PM) for 12 weeks and analyzed as separate cohorts. Baseline (week 0) and post (week 12) muscular strength (1-RM bench/leg press), endurance (sit-ups/push-ups) and power (squat jumps, SJ; bench throws, BT), body composition (iDXA; fat mass, FM; abdominal fat, Abfat), systolic/diastolic blood pressure (BP), respiratory exchange ratio (RER), profile of mood states (POMS), and dietary intake were assessed.  Results:  Twenty-seven women and twenty men completed the 12-week intervention. No differences at baseline existed between groups (AM vs PM) for both women and men cohorts. In women, significant interactions ( p  < 0.05) existed for 1RM bench (8 ± 2 vs 12 ± 2, ∆kg), pushups (9 ± 1 vs 13 ± 2, ∆reps), BT (10 ± 6 vs 45 ± 28, ∆watts), SJ (135 ± 6 vs 39 ± 8, ∆watts), fat mass (-1.0 ± 0.2 vs -0.3 ± 0.2, ∆kg), Abfat (-2.6 ± 0.3 vs -0.9 ± 0.5, ∆kg), diastolic (-10 ± 1 vs-5 ± 5, ∆mmHg) and systolic (-12.5 ± 2.7 vs 2.3 ± 3, mmHg) BP, AM vs PM, respectively. In men, significant interactions ( p  < 0.05) existed for systolic BP (-3.5 ± 2.6 vs -14.9 ± 5.1, ∆mmHg), RER (-0.01 ± 0.01 vs -0.06 ± 0.01, ∆VCO 2 /VO 2 ), and fatigue (-0.8 ± 2 vs -5.9 ± 2, ∆mm), AM vs PM, respectively. Macronutrient intake was similar among AM and PM groups.  Conclusion:  Morning exercise (AM) reduced abdominal fat and blood pressure and evening exercise (PM) enhanced muscular performance in the women cohort. In the men cohort, PM increased fat oxidation and reduced systolic BP and fatigue. Thus, ETOD may be important to optimize individual exercise-induced health and performance outcomes in physically active individuals and may be independent of macronutrient intake.",2022,"In men, significant interactions ( p  < 0.05) existed for systolic BP (-3.5 ± 2.6 vs -14.9 ± 5.1, ∆mmHg), RER (-0.01 ± 0.01 vs -0.06 ± 0.01, ∆VCO 2 /VO 2 ), and fatigue (-0.8 ± 2 vs -5.9 ± 2, ∆mm), AM vs PM, respectively.","['Women', 'Women and Lowers Blood Pressure in Men', 'Thirty exercise-trained women (BMI = 24 ± 3\xa0kg/m 2 ; 42 ± 8\xa0years) and twenty-six men (BMI = 25.5 ± 3\xa0kg/m 2 ; 45 ± 8\xa0years', 'Twenty-seven women and twenty men completed the 12-week intervention', 'women', 'separate cohorts of women and men adhering to different ETOD']","['exercise training', 'Evening Exercise', 'Morning exercise (AM']","['fat oxidation and reduced systolic BP and fatigue', 'systolic BP', 'muscular strength (1-RM bench/leg press), endurance (sit-ups/push-ups) and power (squat jumps, SJ; bench throws, BT), body composition (iDXA; fat mass, FM; abdominal fat, Abfat), systolic/diastolic blood pressure (BP), respiratory exchange ratio (RER), profile of mood states (POMS), and dietary intake', 'reduced abdominal fat and blood pressure and evening exercise (PM) enhanced muscular performance', 'Abdominal Fat and Blood Pressure', 'Macronutrient intake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332170', 'cui_str': 'Morning'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",27.0,0.0483222,"In men, significant interactions ( p  < 0.05) existed for systolic BP (-3.5 ± 2.6 vs -14.9 ± 5.1, ∆mmHg), RER (-0.01 ± 0.01 vs -0.06 ± 0.01, ∆VCO 2 /VO 2 ), and fatigue (-0.8 ± 2 vs -5.9 ± 2, ∆mm), AM vs PM, respectively.","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Arciero', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Ives', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Alex E', 'Initials': 'AE', 'LastName': 'Mohr', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Escudero', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Minicucci', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': ""O'Brien"", 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Curran', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Miller', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Norton', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Sheridan', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Sheriden', 'Initials': 'S', 'LastName': 'Beard', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Centore', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Dudar', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Ehnstrom', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Dakembay', 'Initials': 'D', 'LastName': 'Hoyte', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Mak', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}, {'ForeName': 'Aaliyah', 'Initials': 'A', 'LastName': 'Yarde', 'Affiliation': 'Human Nutrition and Metabolism Laboratory, Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY, United States.'}]",Frontiers in physiology,['10.3389/fphys.2022.893783']
2316,35711298,A memory-reframing intervention to reduce pain in youth undergoing major surgery: Pilot randomized controlled trial of feasibility and acceptability.,"Background


Three to 22% of youth undergoing surgery develop chronic postsurgical pain (CPSP). Negative biases in pain memories (i.e., recalling higher levels of pain as compared to initial reports) are a risk factor for CPSP development. Children's memories for pain are modifiable. Existing memory-reframing interventions reduced negatively biased memories associated with procedural pain and pain after minor surgery. However, not one study has tested the feasibility and acceptability of the memory-reframing intervention in youth undergoing major surgery.
Aims


The current pilot randomized clinical trial (RCT; NCT03110367; clinicaltrials.gov) examined the feasibility and acceptability of, as well as adherence to, a memory reframing intervention.
Methods


Youth undergoing a major surgery reported their baseline and postsurgery pain levels. Four weeks postsurgery, youth and one of their parents were randomized to receive control or memory-reframing instructions. Following the instructions, parents and youth reminisced about the surgery either as they normally would (control) or using the memory-reframing strategies (intervention). Six weeks postsurgery, youth completed a pain memory interview; parents reported intervention acceptability. Four months postsurgery, youth reported their pain.
Results


Seventeen youth (76% girls,  M age   = 14.1 years) completed the study. The intervention was feasible and acceptable. Parents, but not youth, adhered to the intervention principles. The effect sizes of the intervention on youth pain memories ( η p   2  = 0.22) and pain outcomes ( η p   2  = 0.23) were used to inform a larger RCT sample size.
Conclusions


Memory reframing is a promising avenue in pediatric pain research. Larger RCTs are needed to determine intervention efficacy to improve pain outcomes.",2022,"The effect sizes of the intervention on youth pain memories ( η p   2  = 0.22) and pain outcomes ( η p   2  = 0.23) were used to inform a larger RCT sample size.
","['youth undergoing major surgery', 'youth undergoing surgery develop chronic postsurgical pain (CPSP', 'Seventeen youth (76% girls,  M age \xa0 ']","['memory-reframing intervention', 'Existing memory-reframing interventions', 'control or memory-reframing instructions']","['pain', 'intervention acceptability', 'youth pain memories', 'Negative biases in pain memories', 'pain outcomes']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",76.0,0.147187,"The effect sizes of the intervention on youth pain memories ( η p   2  = 0.22) and pain outcomes ( η p   2  = 0.23) were used to inform a larger RCT sample size.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pavlova', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Lund', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of Psychology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Brindle', 'Affiliation': ""Department of Pediatric Surgery, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Noel', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Alberta, Canada.'}]",Canadian journal of pain = Revue canadienne de la douleur,['10.1080/24740527.2022.2058919']
2317,35711279,Anti-Inflammatory Effects of a Period of Aerobic Training and Vitamin D Supplementation in Postmenopausal Women with Metabolic Syndrome.,"Background


Inflammatory markers of blood are critical predictors of chronic diseases as well as exacerbating risk factors. Exercise is a well-known strategy to reduce the risk of inflammation and chronic disease. The present study aimed to investigate the anti-inflammatory effects of a period of aerobic training and vitamin D supplementation (AT + Vit D) in postmenopausal women with metabolic syndrome.
Methods


This quasi-experimental research was performed on forty-six patients with metabolic syndrome who were selected according to the available sampling method, and were randomly divided into four groups: AT + Vit D (50,000 IU), AT, Vit D (50,000 IU), and control (C). The training protocol consisted of 40-60 min of AT 60-75% of maximal heart rate, three times a week, for 8 weeks. One-way Analysis of variance (ANOVA) and  t -test were used to compare the between and within groups; the Bonferroni  post hoc  test was used if significant differences were found.
Results


The combination of exercise and vitamin D significantly reduced C-reactive protein (CRP) ( P  = 0.001), interleukin-6 (IL-6) ( P  = 0.001), and improved the metabolic syndrome indices ( P  = 0.001 in all indices). The results also show that the improvement in the metabolic syndrome indices, CRP, and IL-6 was more significant in AT + Vit D, compared to AT or Vit D alone.
Conclusions


The findings from the present study suggested that a sedentary lifestyle and vitamin D deficiency accelerated the occurrence of metabolic syndrome probably by increasing the anti-inflammatory. Additionally, adequate levels of plasma vitamin D are necessary to achieve the beneficial metabolic effects of AT.",2022,"The combination of exercise and vitamin D significantly reduced C-reactive protein (CRP) ( P  = 0.001), interleukin-6","['postmenopausal women with metabolic syndrome', 'forty-six patients with metabolic syndrome who were selected according to the available sampling method', 'Postmenopausal Women with Metabolic Syndrome']","['exercise and vitamin D', 'AT + Vit D', 'aerobic training and vitamin D supplementation (AT + Vit D', 'Aerobic Training and Vitamin D Supplementation']","['C-reactive protein (CRP', 'metabolic syndrome indices', 'metabolic syndrome indices, CRP, and IL-6', 'interleukin-6']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",46.0,0.034315,"The combination of exercise and vitamin D significantly reduced C-reactive protein (CRP) ( P  = 0.001), interleukin-6","[{'ForeName': 'Parivash Najafi', 'Initials': 'PN', 'LastName': 'Nazarabadi', 'Affiliation': 'Department of Physical Education and Sport Science, Sanandaj Branch, Islamic Azad University, Sunanda, Iran.'}, {'ForeName': 'Zaher', 'Initials': 'Z', 'LastName': 'Etemad', 'Affiliation': 'Department of Physical Education and Sport Science, Sanandaj Branch, Islamic Azad University, Sunanda, Iran.'}, {'ForeName': 'Rastegar', 'Initials': 'R', 'LastName': 'Hoseini', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Razi University, Kermanshah, Iran.'}, {'ForeName': 'Fatah', 'Initials': 'F', 'LastName': 'Moradi', 'Affiliation': 'Department of Physical Education and Sport Sciences, Saghez Branch, Islamic Azad University, Saghez, Iran.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_312_20']
2318,35711705,The Efficacy of Functional Endoscopic Sinus Surgery Combined With Triamcinolone Acetonide Aqueous Nasal Spray for the Treatment of Chronic Rhinosinusitis.,"Objective


We aimed to investigate the efficacy of functional endoscopic sinus surgery (FESS) combined with triamcinolone acetonide aqueous nasal spray (TAA AQ) for the treatment of chronic rhinosinusitis.
Methods


From December 2019 to June 2021, 109 patients with chronic rhinosinusitis were classified into a control group ( n  = 50) and an experimental group ( n  = 59) according to the method of treatment. Subjects in the control group were treated with FESS while those in the experimental group were treated with FESS + TAA AQ. We then compared clinical indices, total effective rate, and the clinical symptoms of patients between the two groups. The pre- and postoperative serum levels of inflammatory cytokines were also determined. Before and 12 months after surgery, we analyzed the recovery of the nasal mucosa, olfactory function, and mucociliary transport rate of each patient. Postoperative complications were observed and recorded and the quality-of-life 12 months after surgery was ascertained.
Results


Clinical indices and total effective rate were higher in the experimental group. After treatment, the VAS score and serum levels of inflammatory cytokines in the two groups both decreased, although the experimental group had lower VAS scores and inflammatory cytokine levels. Six months after treatment, olfactory function, and the recovery of nasal mucosa were improved, MTR had increased, and the total incidence of complications had reduced in the experimental group when compared with the control group. No significant difference was found between the two groups in terms of quality-of-life ( P  > 0.05).
Conclusion


The combination of FESS and TAA AQ exerted a certain therapeutic effect on chronic rhinosinusitis.",2022,"No significant difference was found between the two groups in terms of quality-of-life ( P  > 0.05).
","['109 patients with chronic rhinosinusitis', 'Methods\n\n\nFrom December 2019 to June 2021', 'Chronic Rhinosinusitis', 'chronic rhinosinusitis']","['FESS and TAA AQ', 'functional endoscopic sinus surgery (FESS) combined with triamcinolone acetonide aqueous nasal spray (TAA AQ', 'Functional Endoscopic Sinus Surgery Combined With Triamcinolone Acetonide Aqueous Nasal Spray', 'FESS', 'FESS + TAA AQ']","['VAS score and serum levels of inflammatory cytokines', 'pre- and postoperative serum levels of inflammatory cytokines', 'quality-of-life', 'olfactory function', 'Postoperative complications', 'recovery of the nasal mucosa, olfactory function, and mucociliary transport rate of each patient', 'total incidence of complications', 'Clinical indices and total effective rate', 'VAS scores and inflammatory cytokine levels', 'recovery of nasal mucosa']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0027428', 'cui_str': 'Structure of mucous membrane of nose'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",109.0,0.013895,"No significant difference was found between the two groups in terms of quality-of-life ( P  > 0.05).
","[{'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Hao', 'Affiliation': 'Department of Otolaryngology, Suzhou Hospital of Anhui Medical University, Anhui, China.'}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Department of Otolaryngology, Suzhou Hospital of Anhui Medical University, Anhui, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology, Suzhou Hospital of Anhui Medical University, Anhui, China.'}]",Frontiers in surgery,['10.3389/fsurg.2022.855618']
2319,35711678,"Comparing the effects of a patient-designed-and-informed participant information leaflet in comparison with a standard, researcher-designed information leaflet on recruitment, retention and understanding: A study-within-a-trial.","Background and aim


The process of trial recruitment is vital, given its impact on resources, statistical power and the validity of findings. A participant information leaflet (PIL) is often the initial and primary source of information engaged by potential participants during recruitment. Research suggests that a variety of manipulations to a PIL can be made during its development to enhance understanding, readability and accessibility. In light of this, PIL-design led by  Public and Patient Involvement  (PPI) may also yield positive effects in this respect, as well as consent and retention. This study-within-a-trial (SWAT) compared the effects of a PPI-developed PIL with a standard, researcher-developed PIL on rates of consent, retention, decision certainty, understanding, readability, accessibility, likeability and decision to consent.
Method


This SWAT used a double-blind, two-armed randomised design. The SWAT was conducted within a host trial of cognitive rehabilitation in multiple sclerosis.
Results


A total of 234 people expressed interest in the trial, of which 94 were retained at 6-month follow up. Results revealed no effects on levels of consent and retention between the two PIL groups.
Conclusions


These null effects provide interesting points of discussion and important implications for not only future research on PILs, but also for future research that involves recruitment to health-related interventions.",2022,"Results revealed no effects on levels of consent and retention between the two PIL groups.
","['234 people expressed interest in the trial, of which 94 were retained at 6-month follow up']","['PPI-developed PIL with a standard, researcher-developed PIL']","['levels of consent and retention', 'rates of consent, retention, decision certainty, understanding, readability, accessibility, likeability and decision to consent']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0871211', 'cui_str': 'Readability'}]",234.0,0.123381,"Results revealed no effects on levels of consent and retention between the two PIL groups.
","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Dwyer', 'Affiliation': 'Applied Psychology, School of Social Science, Technological University of the Shannon, Athlone, Ireland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Joyce', 'Affiliation': 'Discipline of Occupational Therapy, School of Health Sciences, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Rogers', 'Affiliation': 'Cardiff University, Cardiff, Wales, UK.'}, {'ForeName': 'Sinéad M', 'Initials': 'SM', 'LastName': 'Hynes', 'Affiliation': 'Discipline of Occupational Therapy, School of Health Sciences, National University of Ireland, Galway, Ireland.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2022.100936']
2320,35711677,"Evaluating the Effectiveness of Community-Based Dementia Caregiver Intervention on Caregiving Burden, Depression, and Attitude Toward Dementia: A Quasi-experimental Study.","Objective


Accumulating evidence of the effects of dementia caregiving on individuals, society, and health has generated intervention studies to reduce the stress among family caregivers of people with dementia. This study aims to evaluate the effectiveness of a family support program, community-based dementia caregiver intervention (CDCI), among family caregivers of people with dementia compared with a control group (no intervention).
Patients and Methods


This study is a quasi-experimental, non-randomized controlled trial conducted in six dementia relief centers of a community healthcare center in Korea. Family caregivers of 83 patients with dementia were recruited; of these 78 were included in the final study, with 40 in the intervention group and 38 in the control group. Analysis of covariance (ANCOVA) was used to compare the mean difference in the scores of the total short-form Zarit Burden Interview (SZBI), personal strain, role strain, depression, and attitude between the groups.
Results


Compared with controls, in the intervention group, the adjusted mean score of personal strain (F = 4.353, t = 0.041) and attitude toward dementia (F = 10.284, t = 0.002) differed significantly after the intervention, with a small to moderate effect. There was no significant difference in the total SZBI, role strain, or depression mean score.
Conclusion


The findings suggest that CDCI may be an effective intervention strategy to reduce personal strain and enhance the attitudes of family caregivers of people with dementia.",2022,"Compared with controls, in the intervention group, the adjusted mean score of personal strain (F = 4.353, t = 0.041) and attitude toward dementia (F = 10.284, t = 0.002) differed significantly after the intervention, with a small to moderate effect.","['family caregivers of people with dementia compared with a control group (no intervention', 'Family caregivers of 83 patients with dementia were recruited; of these 78 were included in the final study, with 40 in the intervention group and 38 in the control group', 'six dementia relief centers of a community healthcare center in Korea', 'family caregivers of people with dementia']","['Community-Based Dementia Caregiver Intervention', 'family support program, community-based dementia caregiver intervention (CDCI', 'CDCI']","['attitude toward dementia', 'adjusted mean score of personal strain', 'total SZBI, role strain, or depression mean score', 'total short-form Zarit Burden Interview (SZBI), personal strain, role strain, depression, and attitude']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",83.0,0.0356466,"Compared with controls, in the intervention group, the adjusted mean score of personal strain (F = 4.353, t = 0.041) and attitude toward dementia (F = 10.284, t = 0.002) differed significantly after the intervention, with a small to moderate effect.","[{'ForeName': 'Su Jung', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Inje University, Gimhae, South Korea.'}, {'ForeName': 'Hyun-Ju', 'Initials': 'HJ', 'LastName': 'Seo', 'Affiliation': 'College of Nursing, Chungnam National University, Daejeon, South Korea.'}, {'ForeName': 'I L Han', 'Initials': 'ILH', 'LastName': 'Choo', 'Affiliation': 'Department of Neuropsychiatry, Chosun University and Chosun University Hospital, Gwangju, South Korea.'}, {'ForeName': 'Seong Min', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Donggang University, Gwangju, South Korea.'}, {'ForeName': 'Jeong Min', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Nambu University, Gwangju, South Korea.'}, {'ForeName': 'Eun-Young', 'Initials': 'EY', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing, Donggang University, Gwangju, South Korea.'}, {'ForeName': 'Yu Mi', 'Initials': 'YM', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, Graduate School of Chungnam National University, Daejeon, South Korea.'}]",Clinical interventions in aging,['10.2147/CIA.S361071']
2321,35711611,Perioperative Protocol of Ankle Fracture and Distal Radius Fracture Based on Enhanced Recovery after Surgery Program: A Multicenter Prospective Clinical Controlled study.,"Background


The enhanced recovery after surgery (ERAS) program is aimed to shorten patients' recovery process and improve clinical outcomes. This study aimed to compare the outcomes between the ERAS program and the traditional pathway among patients with ankle fracture and distal radius fracture.
Methods


This is a multicenter prospective clinical controlled study consisting of 323 consecutive adults with ankle fracture from 12 centers and 323 consecutive adults with distal radial fracture from 13 centers scheduled for open reduction and internal fixation between January 2017 and December 2018. According to the perioperative protocol, patients were divided into two groups: the ERAS group and the traditional group. The primary outcome was the patients' satisfaction of the whole treatment on discharge and at 6 months postoperatively. The secondary outcomes include delapsed time between admission and surgery, length of hospital stay, postoperative complications, functional score, and the MOS item short form health survey-36.
Results


Data describing 772 patients with ankle fracture and 658 patients with distal radius fracture were collected, of which 323 patients with ankle fracture and 323 patients with distal radial fracture were included for analysis. The patients in the ERAS group showed higher satisfaction levels on discharge and at 6 months postoperatively than in the traditional group ( P  < 0.001). In the subgroup analysis, patients with distal radial fracture in the ERAS group were more satisfied with the treatment ( P =0.001). Furthermore, patients with ankle fracture had less time in bed ( P  < 0.001) and shorter hospital stay ( P  < 0.001) and patients with distal radial fracture received surgery quickly after being admitted into the ward in the ERAS group than in the traditional group ( P =0.001).
Conclusions


Perioperative protocol based on the ERAS program was associated with high satisfaction levels, less time in bed, and short hospital stay without increased complication rate and decreased functional outcomes.",2022,"Furthermore, patients with ankle fracture had less time in bed ( P  < 0.001) and shorter hospital stay ( P  < 0.001) and patients with distal radial fracture received surgery quickly after being admitted into the ward in the ERAS group than in the traditional group ( P =0.001).
","['323 consecutive adults with ankle fracture from 12 centers and 323 consecutive adults with distal radial fracture from 13 centers scheduled for open reduction and internal fixation between January 2017 and December 2018', 'Surgery Program', '772 patients with ankle fracture and 658 patients with distal radius fracture were collected, of which 323 patients with ankle fracture and 323 patients with distal radial fracture', 'patients with ankle fracture and distal radius fracture']","['surgery (ERAS) program', 'ERAS', 'Ankle Fracture and Distal Radius Fracture', 'ERAS program']","['time in bed, and short hospital stay without increased complication rate and decreased functional outcomes', 'shorter hospital stay', 'satisfaction levels on discharge', 'distal radial fracture', 'delapsed time between admission and surgery, length of hospital stay, postoperative complications, functional score, and the MOS item short form health survey-36', ""patients' satisfaction of the whole treatment on discharge"", 'distal radial fracture received surgery quickly']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",772.0,0.0369713,"Furthermore, patients with ankle fracture had less time in bed ( P  < 0.001) and shorter hospital stay ( P  < 0.001) and patients with distal radial fracture received surgery quickly after being admitted into the ward in the ERAS group than in the traditional group ( P =0.001).
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Zhi-Jian', 'Initials': 'ZJ', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Wei-Tong', 'Initials': 'WT', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Peng-Cheng', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedic Trauma, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xin-Yu', 'Initials': 'XY', 'LastName': 'Cai', 'Affiliation': ""Department of Orthopaedics, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jun-Bo', 'Initials': 'JB', 'LastName': 'Liang', 'Affiliation': 'Department of Orthopaedics, Taizhou Hospital of Zhejiang Province, Taizhou, China.'}, {'ForeName': 'Jing-Ming', 'Initials': 'JM', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopaedics, Tianjin Hospital, Tianjin, China.'}, {'ForeName': 'Da-Peng', 'Initials': 'DP', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, The General Hospital of Shenyang Military Command, Shenyang, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopaedics, Peking University BinHai Hospital, Tianjin, China.'}, {'ForeName': 'Ming-Xin', 'Initials': 'MX', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedics, Huizhou Third People's Hospital, Huizhou, China.""}, {'ForeName': 'Jiu-Sheng', 'Initials': 'JS', 'LastName': 'He', 'Affiliation': 'Department of Orthopaedics, Beijing Shunyi District Hospital, Beijing, China.'}, {'ForeName': 'Liang-Yuan', 'Initials': 'LY', 'LastName': 'Wen', 'Affiliation': 'Department of Orthopaedics, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Bao-Qing', 'Initials': 'BQ', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopaedics, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, The First Hosptial of Fangshan District, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedics, Shengjing Hospital, China Medical University, Shenyang, China.'}, {'ForeName': 'Feng-Fei', 'Initials': 'FF', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedics, The Second Hospital of Fuzhou, Fuzhou, China.'}, {'ForeName': 'Bing-Zuan', 'Initials': 'BZ', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Quanzhou Orthopaedic Traumatological Hospital, Quanzhou, China.'}, {'ForeName': 'Zong-Xin', 'Initials': 'ZX', 'LastName': 'Shi', 'Affiliation': 'Department of Orthopaedics, Liangxiang Teaching Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bao-Jun', 'Initials': 'BJ', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ai-Guo', 'Initials': 'AG', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Zhengzhou Orthopaedics Hospital, Zhengzhou, China.'}, {'ForeName': 'Gui-Ling', 'Initials': 'GL', 'LastName': 'Peng', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Hong-Hao', 'Initials': 'HH', 'LastName': 'Xiao', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Mi', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Nurtrition, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Chang-Run', 'Initials': 'CR', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Hang-Yu', 'Initials': 'HY', 'LastName': 'Gu', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Zhe-Lun', 'Initials': 'ZL', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Xin-Bao', 'Initials': 'XB', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing, China.'}]",Pain research & management,['10.1155/2022/3458056']
2322,35711596,Effect of DL-Methylephedrine on Dopamine Transporter Using Positron Emission Tomography With [ 18 F]FE-PE2I.,"Rationale


Since ephedrine has a dopamine transporter (DAT) inhibitory effect similar to amphetamine, dl-methylephedrine, a derivative of ephedrine, is considered to have the characteristics of a central nervous system stimulant due to the DAT inhibitory effect. For example, the World Anti-Doping Agency categorizes dl-methylephedrine as a stimulant in the prohibited list for competitions. Assuming to have the same effect as ephedrine, the urinary concentration of dl-methylephedrine is regulated below 10 μg/mL, as is ephedrine. However, the extent to which dl-methylephedrine affects brain function is not yet fully understood.
Objectives


The purpose of this study was to evaluate DAT occupancy by a single oral administration of a daily dose of dl-methylephedrine using positron emission tomography (PET) with [ 18 F]FE-PE2I to characterize its stimulatory effect on the central nervous system.
Methods


Nine healthy male volunteers were enrolled in the study. The experiments were designed as a placebo-controlled randomized double-blind crossover comparative study. After the first PET scan in a drug-free state, the second and third PET scans were performed with randomized dosing at 60 mg of dl-methylephedrine or placebo. The plasma and urine concentrations of dl-methylephedrine were measured just before and after the PET scans, respectively.
Results


Mean urine and plasma concentrations of dl-methylephedrine were 13.9 μg/mL and 215.2 ng/mL, respectively. Mean DAT occupancy in the caudate was 4.4% for dl-methylephedrine and 1.2% for placebo. Mean DAT occupancy in the putamen was 3.6% for dl-methylephedrine and 0.5% for placebo. There was no significant difference of DAT occupancies between the groups.
Conclusion


In this study, the urinary concentration of dl-methylephedrine (13.9 μg/mL) was higher than the prohibited reference value (10.0 μg/mL), and there was no significant difference in DAT occupancy between dl-methylephedrine and placebo. These findings suggest that a clinical daily dose of dl-methylephedrine may exceed the doping regulation value according to urine concentration; however, it was considered that at least the central excitatory effect mediated by DAT inhibition was not observed at the daily dose of dl-methylephedrine.",2022,Mean DAT occupancy in the caudate was 4.4% for dl-methylephedrine and 1.2% for placebo.,['Nine healthy male volunteers'],"['methylephedrine or placebo', 'ephedrine', 'DL-Methylephedrine', 'dl-methylephedrine using positron emission tomography (PET', 'placebo']","['Mean urine and plasma concentrations of dl-methylephedrine', 'DAT occupancy', 'Mean DAT occupancy', 'DAT inhibition', 'plasma and urine concentrations of dl-methylephedrine', 'urinary concentration of dl-methylephedrine', 'DAT occupancies']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0068122', 'cui_str': 'N-methylephedrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C3274810', 'cui_str': 'METHYLEPHEDRINE, DL-'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3274810', 'cui_str': 'METHYLEPHEDRINE, DL-'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}]",9.0,0.250984,Mean DAT occupancy in the caudate was 4.4% for dl-methylephedrine and 1.2% for placebo.,"[{'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Nogami', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Arakawa', 'Affiliation': 'Department of Pharmacology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakayori', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Department of Pharmacology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Okubo', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Amane', 'Initials': 'A', 'LastName': 'Tateno', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2022.799319']
2323,35711582,Group Mindfulness-Integrated Cognitive Behavior Therapy (MiCBT) Reduces Depression and Anxiety and Improves Flourishing in a Transdiagnostic Primary Care Sample Compared to Treatment-as-Usual: A Randomized Controlled Trial.,"Objectives


This study investigated the effectiveness of a group-based 8-week intervention, Mindfulness-integrated Cognitive Behavior Therapy (MiCBT), to decrease psychological distress and increase wellbeing in a heterogeneous population in primary health care. MiCBT focuses on the importance of interoception and its interaction with cognition in emotional experience. These interactions are represented in the co-emergence model of reinforcement, in which non-reactivity (equanimity) to interoceptive signals facilitates adaptive behavior.
Methods


Participants ( n  = 125, aged 20-72) were randomized to two groups (MiCBT), and treatment-as-usual (TAU). Outcomes were assessed at pre-, mid-, and post-intervention and at 6-month follow-up. The primary outcome was psychological distress, measured by the Depression, Anxiety and Stress Scale (DASS-21). Secondary outcome measures were the Kessler Psychological Distress Scale-10 (K10), Satisfaction with Life Scale (SWLS), and Flourishing Scale (FS). Mediator or process measures of interoceptive awareness, metacognitive awareness (decentering), equanimity, and social functioning were included to investigate putative mediators.
Results


The MiCBT intervention significantly reduced DASS-21 scores at mid and post-treatment and the gains were maintained at 6-month follow-up ( p  < 0.0001,  d  = 0.38). Flourishing scores also showed significant improvement post-treatment and at 6-month follow-up ( d  = 0.24,  p  < 0.0001). All measures selected showed a similar pattern of positive change, with the exception of the SWLS, which failed to reach significance. Mediation analysis suggested equanimity to be the most influential mediator of the primary outcome.
Conclusions


The results support the effectiveness of MiCBT in creating rapid and sustainable reduction of psychological distress and improvement in flourishing in a primary mental health care setting with heterogenous groups. These promising results support the scaled-up implementation of this intervention.
Clinical Trial Registration


This trial is registered with the Australian and New Zealand Clinical Trial Registry: https://www.anzctr.org.au/ACTRN12617000061336.",2022,"The MiCBT intervention significantly reduced DASS-21 scores at mid and post-treatment and the gains were maintained at 6-month follow-up ( p  < 0.0001,  d  = 0.38).","['Methods\n\n\nParticipants ( n  = 125, aged 20-72', 'heterogeneous population in primary health care']","['MiCBT', 'Group Mindfulness-Integrated Cognitive Behavior Therapy (MiCBT', 'group-based 8-week intervention, Mindfulness-integrated Cognitive Behavior Therapy (MiCBT']","['psychological distress, measured by the Depression, Anxiety and Stress Scale (DASS-21', 'Flourishing scores', 'psychological distress', 'Depression and Anxiety', 'interoceptive awareness, metacognitive awareness (decentering), equanimity, and social functioning', 'Kessler Psychological Distress Scale-10 (K10), Satisfaction with Life Scale (SWLS), and Flourishing Scale (FS', 'DASS-21 scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C4046092', 'cui_str': 'Meta-cognitive Awareness'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}]",,0.0685533,"The MiCBT intervention significantly reduced DASS-21 scores at mid and post-treatment and the gains were maintained at 6-month follow-up ( p  < 0.0001,  d  = 0.38).","[{'ForeName': 'Sarah E B', 'Initials': 'SEB', 'LastName': 'Francis', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Shawyer', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cayoun', 'Affiliation': 'Mindfulness-Integrated Cognitive Behavior Therapy Institute, Hobart, TAS, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enticott', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Graham N', 'Initials': 'GN', 'LastName': 'Meadows', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2022.815170']
2324,35711561,Amino Acid-Based Formula vs. Extensively Hydrolyzed Formula in the Treatment of Feeding Intolerance in Preterm Infants: Study Protocol for a Randomized Controlled Trial.,"Background


Feeding intolerance is a common problem in preterm infants, which is associated with an increased risk of infections, prolonged hospitalization, and increased economic costs. When human milk is not available, formula feeding is required. Amino acid-based formula and extensively hydrolyzed formula could be considered for use for severe feeding intolerance. A recent Cochrane meta-analysis found that preterm infants fed extensively hydrolyzed formula compared with standard formula could not reduce the risk of feeding intolerance and necrotizing enterocolitis, and weight gain was slower. Some studies reported that preterm infants fed amino acid-based formula could reduce the gastric residual volume. We hypothesize that amino acid-based formula can improve feeding intolerance and establish full enteral feeding more rapidly in preterm infants compared with extensively hydrolyzed formula.
Method


The randomized, prospective, controlled trial was conducted at the Children's Hospital of Chongqing Medical University (Chongqing, China). A total of 190 preterm infants with gestational age <32 weeks or birth weight <1,500 g and with a diagnosis of feeding intolerance were included. Patients were randomized to an amino acid-based formula-fed group and an extensively hydrolyzed formula-fed group. The primary outcome is the time (days) to reach full enteral feedings. Secondary outcomes include duration of vomiting and abdominal distension, gastric residual volume, body weight, length and head circumference during hospitalization, length of hospital stay (days), cost of hospitalization, time (days) of parenteral nutrition, change of abdomen circumference, main serum parameters, and incidence of adverse events.
Discussion


The successful implementation of our study will provide robust evidence for formula alternatives in preterm infants with feeding intolerance.
Clinical Trial Registration


www.ClinicalTrials.gov, identifier: NCT05347706.",2022,"Secondary outcomes include duration of vomiting and abdominal distension, gastric residual volume, body weight, length and head circumference during hospitalization, length of hospital stay (days), cost of hospitalization, time (days) of parenteral nutrition, change of abdomen circumference, main serum parameters, and incidence of adverse events.
","[""Children's Hospital of Chongqing Medical University (Chongqing, China"", '190 preterm infants with gestational age <32 weeks or birth weight <1,500 g and with a diagnosis of feeding intolerance were included', 'preterm infants with feeding intolerance', 'Preterm Infants', 'preterm infants']","['Amino acid-based formula and extensively hydrolyzed formula', 'amino acid-based formula-fed group and an extensively hydrolyzed formula-fed group', 'Amino Acid-Based Formula vs. Extensively Hydrolyzed Formula', 'amino acid-based formula']","['risk of feeding intolerance and necrotizing enterocolitis, and weight gain', 'time (days) to reach full enteral feedings', 'duration of vomiting and abdominal distension, gastric residual volume, body weight, length and head circumference during hospitalization, length of hospital stay (days), cost of hospitalization, time (days) of parenteral nutrition, change of abdomen circumference, main serum parameters, and incidence of adverse events']","[{'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}]","[{'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C3665864', 'cui_str': 'Gastric residual assessment'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",190.0,0.0647485,"Secondary outcomes include duration of vomiting and abdominal distension, gastric residual volume, body weight, length and head circumference during hospitalization, length of hospital stay (days), cost of hospitalization, time (days) of parenteral nutrition, change of abdomen circumference, main serum parameters, and incidence of adverse events.
","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhong', 'Affiliation': ""Department of Neonatology, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ""Department of Neonatology, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Peng', 'Affiliation': ""Department of Neonatology, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing, China.""}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Liang', 'Affiliation': ""Department of Clinical Epidemiology and Bioinformatics, Children's Hospital of Chongqing Medical University, Chongqing, China.""}]",Frontiers in nutrition,['10.3389/fnut.2022.854121']
2325,35711522,The Effect of Calisthenics on Hypoglycemic of Diabetic Patients.,"Objective


To analyze the effect of calisthenics on hypoglycemic in diabetic patients.
Method


From September 2019 to May 2020, 210 patients with type 2 diabetes who were newly diagnosed in our hospital were chosen. They were split into two groups: observation ( n  = 105) and control ( n  = 105). Only drug therapy and diet management were given to the control group, whereas the observation group was given calisthenics treatment in addition to regular diet control and medicine. The outcomes of the two groups of patient's blood glucose levels, BMI, quality of life, and blood lipid index were compared in this study.
Results


Before treatment, there was no significant difference in FPG, 2hPG, and HbA1c levels between the two groups ( P  > 0.05). Compared with before treatment, FPG, 2hPG, and HbA1c were significantly reduced in both groups ( P  < 0.05). In addition, FPG, 2hPG, and HbA1c in the observation group were significantly lower than those in the control group ( P  < 0.05). There was no significant difference in BMI between the two groups before treatment ( P  > 0.05). After treatment, the BMI of the two groups was significantly reduced ( P  < 0.05), and the BMI of the observation group was significantly lower than that of the control group ( P  < 0.05). A comparison of the two groups' SF-36 scale scores before intervention revealed no statistically significant difference ( P  > 0.05). The observation group's SF-36 scores were substantially higher than the control group's after intervention ( P  < 0.05). After treatment, the TC and HDL-c levels in the observation group were not significantly different from those in the control group ( P  > 0.05). Compared with the control group, TG and LDL-C levels were significantly decreased, with statistically significant differences ( P  < 0.05).
Conclusion


Based on routine nursing intervention, using calisthenics to treat blood sugar has a significant effect, it not only made the patient's self-care ability significantly improved, which was worthy of active promotion in clinical practice.",2022,"After treatment, the TC and HDL-c levels in the observation group were not significantly different from those in the control group ( P  > 0.05).","['210 patients with type 2 diabetes who were newly diagnosed in our hospital were chosen', 'Diabetic Patients', 'diabetic patients']","['Calisthenics', 'calisthenics']","['SF-36 scale scores', 'BMI', 'SF-36 scores', 'TG and LDL-C levels', 'blood glucose levels, BMI, quality of life, and blood lipid index', 'FPG, 2hPG, and HbA1c levels', 'FPG, 2hPG, and HbA1c', 'TC and HDL-c levels']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0006759', 'cui_str': 'Calisthenics'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",210.0,0.0107584,"After treatment, the TC and HDL-c levels in the observation group were not significantly different from those in the control group ( P  > 0.05).","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Weifang Engineering Vocational College, China.'}, {'ForeName': 'Haili', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': 'Weifang Engineering Vocational College, China.'}]",BioMed research international,['10.1155/2022/7737626']
2326,35711500,Application Analysis of Multiacupoint Stimulation in Multimodal Labor Analgesia during the Whole Stage of Labor in Primipara.,"Purpose


To analyze the application value of multimodal analgesia (MMA) regimen of patient-controlled epidural analgesia (PCEA) combined with multiacupoint stimulation analgesia during the whole stage of labor analgesia in primipara.
Methods


300 primiparas with natural delivery were selected. According to the different ways of labor analgesia, they were divided into the first stage of labor active period PCEA group (group A), the whole stage of labor PCEA group (group W), and the whole stage of labor PCEA combined with multiacupoint stimulation analgesia group (group WM). The effect of MMA during the whole-labor process on maternal and infant safety was evaluated. The specific observation indicators were as follows: visual analogue scale (VAS) scores before analgesia ( T   0 ), at full opening of the uterus ( T   1 ), at the end of the second stage of labor ( T   2 ), and at the end of the third stage of labor ( T   3 ); stress response indicators at  T   0  and  T   1 : epinephrine ( E ), norepinephrine (NE), glucose (Glu), and  β -endorphin ( β -EP) levels; delivery time of each stage of labor; the Apgar score of newborns at 1 and 5 min after birth; indicators of umbilical artery blood gas analysis immediately after delivery: PH value, base excess (BE), partial pressure of oxygen (PaO 2 ), and partial pressure of carbon dioxide (PaCO 2 ); incidence of postpartum depression (PPD) at 6 weeks after delivery.
Results


At  T   1 ,  T   2 , and  T   3 , the VAS scores were lower in groups W and WM than in group A, and the VAS scores were lower in group WM than in group W ( P  < 0.05). At  T   0 , there was no significant difference in the comparison of  E , NE, Glu, and  β -EP levels among the three groups ( P  > 0.05). At  T   1 , the levels of  E , NE, Glu, and  β -EP were higher in the three groups than in the same group at  T   0 , the levels of  E , NE, and Glu were lower, the levels of  β -EP were higher in groups W and WM than in group A, and the levels of  β -EP were higher in group WM than in group W ( P  < 0.05). Comparing the delivery time of the first stage of labor in the three groups, groups A and WM were shorter than group W ( P  < 0.05). Comparing the delivery time of the second and third stages of labor in the three groups, there was no significant difference ( P  > 0.05). Comparing the Apgar scores of the three groups of newborns at 1 and 5 min after birth, there was no significant difference ( P  > 0.05). Comparing the incidence of newborn asphyxia in the three groups, there was also no significant difference ( P  > 0.05). Comparing the PH, BE, PaO 2 , and PaCO 2  of three groups of newborns after delivery, there were no significant differences ( P  > 0.05). At 6 weeks after delivery, the incidence of PPD was lower in groups W (10.00%) and WM (8.00%) than in group A (20.00%) ( P  < 0.05).
Conclusion


The application of the MMA regimen of PCEA combined with multiacupoint stimulation for labor analgesia during the whole stage of labor in primipara can effectively reduce labor pain and stress response during the whole stage of labor and shorten the delivery time of the first stage of labor, the indicators of newborn Apgar score and umbilical artery blood gas analysis are not affected, and the incidence of PPD in patients is reduced, which can play a protective role for the safety of mother and infant.",2022,"At  T   1 , the levels of  E , NE, Glu, and  β -EP were higher in the three groups than in the same group at  T   0 , the levels of  E , NE, and Glu were lower, the levels of  β -EP were higher in groups W and WM than in group A, and the levels of  β -EP were higher in group WM than in group W ( P  < 0.05).","['Multimodal Labor Analgesia during the Whole Stage of Labor in Primipara', '300 primiparas with natural delivery were selected', 'labor analgesia in primipara']","['multimodal analgesia (MMA) regimen of patient-controlled epidural analgesia (PCEA) combined with multiacupoint stimulation analgesia', 'PCEA combined with multiacupoint stimulation', 'Multiacupoint Stimulation', 'MMA', 'labor PCEA combined with multiacupoint stimulation analgesia', 'endorphin']","['epinephrine ( E ), norepinephrine (NE), glucose (Glu), and  β', 'comparison of  E , NE, Glu, and  β -EP levels', 'newborn Apgar score and umbilical artery blood gas analysis', 'newborn asphyxia', 'incidence of PPD', 'maternal and infant safety', 'Apgar scores', 'levels of  β -EP', ' β -EP) levels; delivery time of each stage of labor; the Apgar score of newborns at 1 and 5\u2009min after birth; indicators of umbilical artery blood gas analysis immediately after delivery: PH value, base excess (BE), partial pressure of oxygen (PaO 2 ), and partial pressure of carbon dioxide (PaCO 2 ); incidence of postpartum depression (PPD', 'labor pain and stress response', 'visual analogue scale (VAS) scores before analgesia ( T   0 ), at full opening of the uterus ( T   1 ', 'levels of  E , NE, Glu, and  β -EP', 'VAS scores']","[{'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0061055', 'cui_str': 'gamma-glutamyl-alpha-aminobutyrate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201985', 'cui_str': 'Delta base, blood'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",300.0,0.0589588,"At  T   1 , the levels of  E , NE, Glu, and  β -EP were higher in the three groups than in the same group at  T   0 , the levels of  E , NE, and Glu were lower, the levels of  β -EP were higher in groups W and WM than in group A, and the levels of  β -EP were higher in group WM than in group W ( P  < 0.05).","[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Men', 'Affiliation': ""Department of Anesthesiology, Hangzhou Women's Hospital, Hangzhou, Zhejiang 310008, China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Department of Gynaecology, Hangzhou Women's Hospital, Hangzhou, Zhejiang 310008, China.""}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': ""Department of Anesthesiology, Hangzhou Women's Hospital, Hangzhou, Zhejiang 310008, China.""}, {'ForeName': 'Zhenzhao', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Department of Anesthesiology, Hangzhou Women's Hospital, Hangzhou, Zhejiang 310008, China.""}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Hangzhou Women's Hospital, Hangzhou, Zhejiang 310008, China.""}, {'ForeName': 'Hongda', 'Initials': 'H', 'LastName': 'Yi', 'Affiliation': ""Department of Anesthesiology, Hangzhou Women's Hospital, Hangzhou, Zhejiang 310008, China.""}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Hangzhou Women's Hospital, Hangzhou, Zhejiang 310008, China.""}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/5161562']
2327,35711499,IGST Combined with Conventional Drug Therapy and TCM Therapy for Treatment of Bilateral Vestibular Hypofunction.,"Objective


To investigate the effects of intensive gaze stability training (IGST) combined with conventional drug therapy and traditional Chinese medicine (TCM) therapy on hearing recovery and quality of life (QOL) in patients with bilateral vestibular dysfunction.
Materials and Methods


A total of 120 patients with bilateral vestibular dysfunction admitted to our hospital from January 2019 to January 2020 were recruited and assigned to group A ( n  = 60) and group B ( n  = 60) based on the order of admission. Group B received conventional medication and TCM therapy, and group A received IGST plus conventional medication and TCM therapy. The serum biochemical indexes, blood rheology indexes, symptoms disappearance time, hearing recovery time, pure-tone hearing threshold, vestibular symptom index (VSI), and QOL of the two groups were compared.
Results


The serum biochemical indexes and blood rheology indexes in group A were lower than those in group B after treatment ( P  < 0.001). Patients in group A had a shorter time lapse before symptoms disappearance and hearing recovery than those in group B ( P  < 0.001). Group A had lower results of the pure-tone hearing threshold ( P  < 0.001) and of VSI ( P  < 0.05) than group B. Patients in group A had higher QOL scores than those in group B after treatment ( P  < 0.001).
Conclusion


IGST plus conventional drug therapy effectively improves the serum biochemical indexes and blood rheological indexes of patients with bilateral vestibular hypofunction, accelerates their hearing recovery process, and alleviates their clinical symptoms, thereby improving their QOL, which shows good potential in clinical application.",2022,"Group A had lower results of the pure-tone hearing threshold ( P  < 0.001) and of VSI ( P  < 0.05) than group B. Patients in group A had higher QOL scores than those in group B after treatment ( P  < 0.001).
","['120 patients with bilateral vestibular dysfunction admitted to our hospital from January 2019 to January 2020', 'patients with bilateral vestibular hypofunction', 'patients with bilateral vestibular dysfunction']","['IGST plus conventional medication and TCM therapy', 'intensive gaze stability training (IGST) combined with conventional drug therapy and traditional Chinese medicine (TCM) therapy', 'conventional medication and TCM therapy', 'IGST Combined with Conventional Drug Therapy and TCM Therapy']","['hearing recovery and quality of life (QOL', 'serum biochemical indexes, blood rheology indexes, symptoms disappearance time, hearing recovery time, pure-tone hearing threshold, vestibular symptom index (VSI), and QOL', 'serum biochemical indexes and blood rheology indexes', 'VSI', 'QOL scores', 'pure-tone hearing threshold', 'serum biochemical indexes and blood rheological indexes', 'shorter time lapse before symptoms disappearance and hearing recovery']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0035423', 'cui_str': 'Rheology'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",120.0,0.0213931,"Group A had lower results of the pure-tone hearing threshold ( P  < 0.001) and of VSI ( P  < 0.05) than group B. Patients in group A had higher QOL scores than those in group B after treatment ( P  < 0.001).
","[{'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, No. 2 Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, No. 2 Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, No. 2 Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/5689454']
2328,35711498,Comparison of the Efficacy and Safety of Neuroendoscopic Endonasal Transsphenoidal Surgeries and Intracranial Endoscopic Pterional Approach in Resection of Tuberculum Sellae Meningiomas.,"Objective


To compare of the efficacy and safety of neuroendoscopic endonasal transsphenoidal surgeries and intracranial endoscopic pterional approach in resection of tuberculum sellae meningioma.
Methods


From January 2014 to June 2021, 60 patients with tuberculum sellae meningioma diagnosed and treated in our hospital were enrolled and randomly divided into study group and control group. The tuberculum sellae meningioma was removed by neuroendoscopic endonasal transsphenoidal surgeries in the study group, while the intracranial endoscopic pterional approach was used in the control group. The chi-square test was used to compare the differences of tumor complete resection rate, visual acuity improvement rate, total effective rate at 3 months after operation, and adverse reactions between the two groups.
Results


The clinical characteristics of the two groups were comparable ( P  > 0.05). After surgical treatment, the complete resection rate in the study group was higher than that in the control group (93.3% vs 70.0%), and the difference was statistically significant ( P =0.020). After treatment, the visual acuity improvement rate of the study group was 83.3% (25/30), which was significantly higher than that of the control group (60.0%, 18/30), and the difference was statistically significant ( χ   2  = 4.022,  P =0.045). After surgical treatment, the total effective rate at 3 months after operation was higher in the study group than in the control group (96.7% vs 83.3%), with statistical significance ( P =0.041). There was no significant difference in postoperative adverse reactions between the study group and control group (33.3% vs 30.0%,  P =0.781).
Conclusion


The neuroendoscopic endonasal transsphenoidal surgeries has significant efficacy and can significantly improve the visual acuity of patients without increasing adverse reactions, which is worthy of clinical promotion.",2022,"After surgical treatment, the total effective rate at 3 months after operation was higher in the study group than in the control group (96.7% vs 83.3%), with statistical significance ( P =0.041).","['From January 2014 to June 2021, 60 patients with tuberculum sellae meningioma diagnosed and treated in our hospital']","['neuroendoscopic endonasal transsphenoidal surgeries and intracranial endoscopic pterional approach', 'neuroendoscopic endonasal transsphenoidal surgeries', 'Neuroendoscopic Endonasal Transsphenoidal Surgeries and Intracranial Endoscopic Pterional Approach']","['total effective rate', 'complete resection rate', 'visual acuity', 'efficacy and safety', 'visual acuity improvement rate', 'tumor complete resection rate, visual acuity improvement rate, total effective rate', 'postoperative adverse reactions', 'adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230049', 'cui_str': 'Structure of tuberculum sellae'}, {'cui': 'C0025286', 'cui_str': 'Meningioma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0225425', 'cui_str': 'Internal nose structure'}, {'cui': 'C0205508', 'cui_str': 'Transsphenoidal approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",60.0,0.0297825,"After surgical treatment, the total effective rate at 3 months after operation was higher in the study group than in the control group (96.7% vs 83.3%), with statistical significance ( P =0.041).","[{'ForeName': 'Zhenrong', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Department of Neurosurgery, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian 363000, China.'}, {'ForeName': 'Ziyue', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Nephrology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian 363000, China.'}, {'ForeName': 'Yuzhe', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian 363000, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian 363000, China.'}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurosurgery, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian 363000, China.'}, {'ForeName': 'Ruisheng', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Neurosurgery, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian 363000, China.'}, {'ForeName': 'Aishun', 'Initials': 'A', 'LastName': 'Guo', 'Affiliation': 'Department of Neurosurgery, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian 363000, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/4542815']
2329,35711492,Does prior transurethral resection of prostate have a negative impact on the outcome of holmium laser enucleation of prostate? Results from a prospective comparative study.,"Objectives


To prospectively evaluate safety and efficacy of holmium laser enucleation of prostate (HoLEP) for surgical treatment of recurrent symptoms due to prostatomegaly after prior transurethral resection of prostate (TURP).
Materials and Methods


We prospectively evaluated 43 patients with a history of TURP who underwent HoLEP (study group). Patients in chronological order who underwent HoLEP without prior TURP were included in the control group. We hypothesized that prior TURP would increase technical difficulties, thereby leading to a reduction in procedure efficiency by 25%. Patients' demographic, intraoperative, and postoperative data were compared, and statistical analysis was performed.
Results


Demographic data in both groups were comparable. The average interval between past TURP and HoLEP was 4.22 years. There was no difficulty in identifying the dissection plane in the study group and the difference in the procedure efficiency between the study and the control groups were statistically insignificant (0.75 ± 0.31 g/min-study group vs. 0.69 ± 0.36 g/min-control group;  P  = 0.665). The intraoperative parameters and postoperative outcomes were comparable in both groups.
Conclusions


Prior TURP does not negatively impact the outcome of HoLEP in treating symptomatic recurrence for enlarged prostate after initial TURP.",2022,"Conclusions


Prior TURP does not negatively impact the outcome of HoLEP in treating symptomatic recurrence for enlarged prostate after initial TURP.","['recurrent symptoms due to prostatomegaly after prior transurethral resection of prostate (TURP', 'Patients in chronological order who underwent HoLEP without prior TURP were included in the control group', '43 patients with a history of TURP who underwent HoLEP (study group']","['HoLEP', 'TURP', 'holmium laser enucleation', 'holmium laser enucleation of prostate (HoLEP']","['intraoperative parameters and postoperative outcomes', 'dissection plane', 'safety and efficacy', 'procedure efficiency']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C3698057', 'cui_str': 'Holmium laser enucleation of prostate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1997308', 'cui_str': 'History of transurethral prostatectomy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3698057', 'cui_str': 'Holmium laser enucleation of prostate'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",43.0,0.0405064,"Conclusions


Prior TURP does not negatively impact the outcome of HoLEP in treating symptomatic recurrence for enlarged prostate after initial TURP.","[{'ForeName': 'Usama', 'Initials': 'U', 'LastName': 'Khater', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Nicholas Anthony', 'Initials': 'NA', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Katz', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Bhat', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Indraneel', 'Initials': 'I', 'LastName': 'Banerjee', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Rashmi H', 'Initials': 'RH', 'LastName': 'Shah', 'Affiliation': 'Urolap Superspeciality Clinic and S. L. Raheja (Fortis Associate Hospital), Mumbai, Maharashtra, India.'}, {'ForeName': 'Hemendra N', 'Initials': 'HN', 'LastName': 'Shah', 'Affiliation': 'Department of Urology, University of Miami, Miller School of Medicine, Miami, Florida, USA.'}]",Urology annals,['10.4103/ua.ua_106_21']
2330,35715802,Analysing root roughness and smear layer relationship by comparing contemporary dental curettes with conventional dental curettes: a randomised controlled trial.,"BACKGROUND


Root debridement procedures for the treatment of periodontal diseases, produces root surface irregularities and smear layer on the root surface that can adversely affect the healing of periodontal tissues. The objective of the present study was to evaluate the surface texture of root after hand instrumentation with Gracey curette, After Five curette, and Mini Five curette.
METHODS


A randomised, controlled clinical trial was conducted with 120 participants clinically diagnosed with chronic periodontitis. Participants were equally randomised into four groups, with parallel treatment assignment of scaling and root planning using Gracey Curettes, After five and Mini five curette, and a control group with no instrumentation. Mobile teeth of these patients were then extracted atraumatically and analysed under a Scanning Electron Microscope and graded for ""Roughness and Loss of Tooth substance index"" and ""Smear layer index."" Cross Tabulation was made between the test groups (Control, Gracey Curette, After five, and Mini Five) versus ""Roughness and Loss of Tooth substance Index"" and ""Smear Layer Index."" A Chi-square test with Bonferroni correction was used to determine the graded distribution among the groups.
RESULTS


In the control group, 73.3% of the teeth showed grade 1 roughness. In the Gracey group, 56.7% showed grade 2 roughness; in the After 5 group, 70% showed grade 3 roughness; in the Mini 5 group, 76.7% showed grade 3 roughness. A significant association was found between roughness scores and the use of individual instruments. Regarding smear layer formation, 46.7% of teeth showed a grade 4 smear layer in the control group. 50% of teeth showed grade 2 smear layer thickness in the Gracey group. In the After 5 group, 73.3% of teeth showed a grade 1 smear layer, while in the Mini 5 group, 80.0% showed a grade 1 smear layer. The use of individual instruments was significantly associated with the smear layer scores.
CONCLUSION


Gracey curettes produced relatively smoother root surfaces with less smear layer formation than After Five and Mini Five curettes, which produced relatively more roughened root surfaces with thicker smear layer formation.
TRIAL REGISTRATION


ID: ClinicalTrials.gov Identifier: NCT04216966 Date of Registration: January 3, 2020.",2022,"Gracey curettes produced relatively smoother root surfaces with less smear layer formation than After Five and Mini Five curettes, which produced relatively more roughened root surfaces with thicker smear layer formation.
",['120 participants clinically diagnosed with chronic periodontitis'],"['conventional dental curettes', 'scaling and root planning using Gracey Curettes, After five and Mini five curette, and a control group with no instrumentation', 'Gracey curettes', 'Gracey curette, After Five curette, and Mini Five curette', 'Bonferroni correction']","['grade 2 smear layer thickness', 'Roughness and Loss of Tooth substance Index"" and ""Smear Layer Index', 'Roughness and Loss of Tooth substance index"" and ""Smear layer index', 'grade 1 smear layer', 'smear layer scores', 'grade 2 roughness', 'grade 1 roughness', 'grade 3 roughness', 'roughness scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0180236', 'cui_str': 'Curette'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",120.0,0.0951807,"Gracey curettes produced relatively smoother root surfaces with less smear layer formation than After Five and Mini Five curettes, which produced relatively more roughened root surfaces with thicker smear layer formation.
","[{'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Riaz', 'Affiliation': 'Department of Periodontology, Baqai Dental College, Baqai Medical University, Karachi, Pakistan. drsaniazia9@gmail.com.'}, {'ForeName': 'Shahbaz', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Department of Operative Dentistry, Dr Ishrat Ul Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Sumaiya', 'Initials': 'S', 'LastName': 'Shabbir', 'Affiliation': 'Department of Periodontology, Dow International Dental College, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Ziaur Rahman', 'Initials': 'ZR', 'LastName': 'Khan', 'Affiliation': 'Department of Oral Medicine, Baqai Dental College, Baqai Medical University, Karachi, Pakistan.'}, {'ForeName': 'Syed Jaffar Abbas', 'Initials': 'SJA', 'LastName': 'Zaidi', 'Affiliation': 'Department of Oral Biology, Dow Dental College, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Meshal Muhammad', 'Initials': 'MM', 'LastName': 'Naeem', 'Affiliation': 'Department of Periodontology, Dr Ishrat Ul Ebad Khan Institute of Oral Health Sciences, Dow University of Oral Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Waqas Ahmed', 'Initials': 'WA', 'LastName': 'Farooqui', 'Affiliation': 'School of Public Health, Dow University of Health Sciences, Karachi, Pakistan.'}]",BMC oral health,['10.1186/s12903-022-02268-1']
2331,35715786,The effect of a tele-educational intervention on modifying dysfunctional sexual beliefs of pregnant women: a randomized controlled trial.,"BACKGROUND & AIM


Some cultural scenarios in pregnancy and childbirth reinforce dysfunctional sexual beliefs that reverse changes in the couple's sexual life. The present study aimed to investigate the effect of education by sending text messages on modifying dysfunctional sexual beliefs in pregnant women.
METHODS & MATERIALS


This study is a randomized clinical trial, and 82 eligible pregnant women referred to educational-medical centers to receive prenatal care were randomly assigned to intervention or control group. The intervention group received 24 text messages during eight weeks (three text messages per week), and the control group received only routine care. Data was collected through a demographic questionnaire, reproductive profile, Spinner's Dyadic Adjustment Scale (DAS), and dysfunctional sexual beliefs questionnaire. Both groups completed the questionnaires before and one week after the intervention. Independent t-test, paired t-test, and analysis of covariance was used to analyze the data.
RESULTS


The findings revealed no statistically significant difference in the baseline Dyadic Adjustment mean scores of control (132.4 ± 11.01) and intervention (130.10 ± 10.66) groups. Paired t-test analysis showed that the mean score of dysfunctional sexual beliefs was significantly decreased from (29 ± 7.61) at baseline compared to one week after intervention (10.54 ± 6.97) (p < 0.001). Analysis of covariance test to compare the scores of dysfunctional sexual beliefs in the intervention group (10.54 ± 6.97) and control group (26.80 ± 7.80) showed a statistically significant difference (p < 0.01) with an effect size of 0.67.
CONCLUSION


This study showed that sending text messages to mobile phones of pregnant women has corrected their dysfunctional sexual beliefs. Therefore, this approach can be used in pregnancy care to promote women's sexual health.
TRIAL REGISTRATION


Clinical trial registry: IRCT20161230031662N9 .",2022,The findings revealed no statistically significant difference in the baseline Dyadic Adjustment mean scores of control (132.4 ± 11.01) and intervention (130.10 ± 10.66) groups.,"['82 eligible pregnant women referred to educational-medical centers to receive prenatal care', 'pregnant women']","['control group received only routine care', 'education by sending text messages', 'tele-educational intervention']","['dysfunctional sexual beliefs', 'mean score of dysfunctional sexual beliefs', 'scores of dysfunctional sexual beliefs', ""demographic questionnaire, reproductive profile, Spinner's Dyadic Adjustment Scale (DAS), and dysfunctional sexual beliefs questionnaire""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0402790', 'cui_str': 'Spinner'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0543547,The findings revealed no statistically significant difference in the baseline Dyadic Adjustment mean scores of control (132.4 ± 11.01) and intervention (130.10 ± 10.66) groups.,"[{'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Khoddam', 'Affiliation': 'Student Research Committee, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Lotfi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Alborz University of Medical Sciences, 1st Golestan- Eshteraki Boulevard, Baghestan, Karaj, Iran. raziehlotfi@abzums.ac.ir.'}, {'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Kabir', 'Affiliation': 'Social Determinants of Health Research Center, Alborz University of Medical Sciences, 1st Golestan- Eshteraki Boulevard, Baghestan, Karaj, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Merghati-Khoei', 'Affiliation': 'Spinal Cord Injury Research Center (BASIR), Neuroscience Institution, Tehran University of Medical Sciences, Tehran, Iran.'}]",BMC pregnancy and childbirth,['10.1186/s12884-022-04773-1']
2332,35715774,"Effect of alendronate sodium plus vitamin D 3  tablets on knee joint structure and osteoarthritis pain: a multi-center, randomized, double-blind, placebo-controlled study protocol.","BACKGROUND


Osteoarthritis (OA) is a major cause of pain and disability worldwide. Despite the relatively high burden of the disease, the currently available non-surgical treatment options are directed towards symptomatic relief. Therefore, we propose the use of alendronate as a disease modifying agent to help slow and prevent OA. In addition, this study will utilize Whole-Organ Magnetic Resonance Imaging Score (WORMS) to evaluate the structural integrity of cartilage in the study population. High-quality evidence, limited to a few well-conducted randomized trials, highlights contradictory results on the effect of bisphosphonates on knee function and progression of OA. Therefore, a placebo-controlled, randomized trial is needed to evaluate the combined effect of alendronate and vit D on the structure of cartilage utilizing the WORMS score and its ability to treat knee pain in OA patients.
METHODS


This multicenter, randomized, double-blinded, placebo-controlled study will evaluate the efficacy and safety of alendronate in early OA. Patients will undergo a 1:1 double-blinded randomization to receive a one-year course of either alendronate sodium vitamin D 3  or placebo. The primary outcome is to compare WORMS score of knee joint at 6 and 12 months between both groups. Secondary endpoints will include WORMS score at 24 months, knee pain, radiographic progression of OA, severity of OA, quality of life, and serum inflammatory biomarkers at different assessment timepoints. To detect a 2.2% difference in cartilage loss between both groups with power of 80%, a sample size of 60 (30 per group) is proposed.
DISCUSSION


This trial will give helpful and high-quality evidence regarding the potential therapeutic role of alendronate sodium vitamin D3, as compared to placebo, in the management of patients with knee OA regarding its role on cartilage loss, radiographic progression of OA, severity of OA, knee pain, quality of life, and inflammatory biomarkers. If proven effective, this intervention would be a great option for providing beneficial outcomes with a reduced cost in this patient population.
TRIAL REGISTRATION


This trial was registered on clinicaltrials.gov (registration number: NCT04739592 ).",2022,"If proven effective, this intervention would be a great option for providing beneficial outcomes with a reduced cost in this patient population.
","['patients with knee OA', 'OA patients']","['alendronate sodium plus vitamin D 3  tablets', 'alendronate sodium vitamin D3', 'alendronate', 'bisphosphonates', 'alendronate sodium vitamin D 3  or placebo', 'placebo', 'alendronate and vit D']","['efficacy and safety', 'WORMS score at 24\xa0months, knee pain, radiographic progression of OA, severity of OA, quality of life, and serum inflammatory biomarkers', 'knee function and progression of OA', 'knee joint structure and osteoarthritis pain', 'cartilage loss, radiographic progression of OA, severity of OA, knee pain, quality of life, and inflammatory biomarkers', 'WORMS score of knee joint', 'cartilage loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0700482', 'cui_str': 'Alendronate sodium'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}]",,0.693093,"If proven effective, this intervention would be a great option for providing beneficial outcomes with a reduced cost in this patient population.
","[{'ForeName': 'Hui-Ming', 'Initials': 'HM', 'LastName': 'Peng', 'Affiliation': 'Department of Orthopaedic Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No.1, Shuaifuyuan Wangfujing, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xi-Sheng', 'Initials': 'XS', 'LastName': 'Weng', 'Affiliation': 'Department of Orthopaedic Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No.1, Shuaifuyuan Wangfujing, Dongcheng District, Beijing, 100730, China. Xishengweng2020@163.com.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No.1, Shuaifuyuan Wangfujing, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopaedic Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No.1, Shuaifuyuan Wangfujing, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Department of Orthopaedic Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No.1, Shuaifuyuan Wangfujing, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Dao-Zhang', 'Initials': 'DZ', 'LastName': 'Cai', 'Affiliation': 'Department of Joint Surgery, Center for Orthopaedic Surgery, The Third Affiliated Hospital of Southern Medical University, Guangzhou, 510630, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Joint Surgery, Center for Orthopaedic Surgery, The Third Affiliated Hospital of Southern Medical University, Guangzhou, 510630, China.'}, {'ForeName': 'Zhen-Jun', 'Initials': 'ZJ', 'LastName': 'Yao', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Shengcheng', 'Initials': 'S', 'LastName': 'Wan', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital Fudan University, Shanghai, 200032, China.'}]",BMC musculoskeletal disorders,['10.1186/s12891-022-05521-4']
2333,35715764,Frequency and duration of extreme hypoxemic and hyperoxemic episodes during manual and automatic oxygen control in preterm infants: a retrospective cohort analysis from randomized studies.,"OBJECTIVE


Neonatal exposure to episodic hypoxemia and hyperoxemia is highly relevant to outcomes. Our goal was to investigate the differences in the frequency and duration of extreme low and high SpO 2  episodes between automated and manual inspired oxygen control.
DESIGN


Post-hoc analysis of a cohort from prospective randomized cross-over studies.
SETTING


Seven tertiary care neonatal intensive care units.
PATIENTS


Fifty-eight very preterm neonates (32 or less weeks PMA) receiving respiratory support and supplemental oxygen participating in an automated versus manual oxygen control cross-over trial.
MAIN MEASURES


Extreme hypoxemia was defined as a SpO 2  < 80%, extreme hyperoxemia as a SpO 2  > 98%. Episode duration was categorized as < 5 seconds, between 5 to < 30 seconds, 30 to < 60 seconds, 60 to < 120 seconds, and 120 seconds or longer.
RESULTS


The infants were of a median postmenstrual age of 29 (28-31) weeks, receiving a median FiO 2  of 0.28 (0.25-0.32) with mostly receiving non-invasive respiratory support (83%). While most of the episodes were less than 30 seconds, longer episodes had a marked effect on total time exposure to extremes. The time differences in each of the three longest durations episodes (30, 60, and 120 seconds) were significantly less during automated than during manual control (p < 0.001). Nearly two-third of the reduction of total time spent at the extremes between automated and manual control (3.8 to 2.1% for < 80% SpO 2  and 3.0 to 1.6% for > 98% SpO 2 ) was seen in the episodes of at least 60 seconds.
CONCLUSIONS


This study shows that the majority of episodes preterm infants spent in SpO 2  extremes are of short duration regardless of manual or automated control. However, the infrequent longer episodes not only contribute the most to the total exposure, but also their reduction in frequency to the improvement associated with automated control.",2022,"Nearly two-third of the reduction of total time spent at the extremes between automated and manual control (3.8 to 2.1% for < 80% SpO 2  and 3.0 to 1.6% for > 98% SpO 2 ) was seen in the episodes of at least 60 seconds.
","['infants were of a median postmenstrual age of 29 (28-31) weeks, receiving a median FiO 2  of 0.28 (0.25-0.32) with mostly receiving non-invasive respiratory support (83', 'Seven tertiary care neonatal intensive care units', 'Fifty-eight very preterm neonates (32 or less weeks PMA) receiving respiratory support and supplemental oxygen participating in an automated versus manual oxygen control cross-over trial', 'preterm infants']",['manual and automatic oxygen control'],"['Episode duration', 'total time spent', 'total time exposure']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517445', 'cui_str': '0.28'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C4517448', 'cui_str': '0.32'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0039654', 'cui_str': '12-O-Tetradecanoyl Phorbol 13-Acetate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",58.0,0.12488,"Nearly two-third of the reduction of total time spent at the extremes between automated and manual control (3.8 to 2.1% for < 80% SpO 2  and 3.0 to 1.6% for > 98% SpO 2 ) was seen in the episodes of at least 60 seconds.
","[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Bachman', 'Affiliation': 'Czech Technical University in Prague, School of Biomedical Engineering, Prague, Czech Republic. tbachman@me.com.'}, {'ForeName': 'Wes', 'Initials': 'W', 'LastName': 'Onland', 'Affiliation': ""Emma Children's Hospital, Department of Neonatology, Amsterdam UMC, Amsterdam, Netherlands.""}, {'ForeName': 'Anton H', 'Initials': 'AH', 'LastName': 'van Kaam', 'Affiliation': ""Emma Children's Hospital, Department of Neonatology, Amsterdam UMC, Amsterdam, Netherlands.""}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Roubik', 'Affiliation': 'Czech Technical University in Prague, School of Biomedical Engineering, Prague, Czech Republic.'}, {'ForeName': 'Helmut D', 'Initials': 'HD', 'LastName': 'Hummler', 'Affiliation': 'Department of Neonatology, University Hospital, Tuebingen, Germany.'}, {'ForeName': 'Mithilesh', 'Initials': 'M', 'LastName': 'Lal', 'Affiliation': 'James Cook University Hospital, Neonatology, South Tees NHS Trust, Middlesbrough, UK.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lista', 'Affiliation': ""Vittore Buzzi Children's Hospital, Neonatology, Milan, Italy.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Fajardo', 'Affiliation': ""Alberta Children's Hospital, Neonatology, Calgary, Canada.""}]",BMC pediatrics,['10.1186/s12887-022-03407-x']
2334,35715661,Randomized Policy Evaluation of the Veterans Health Administration Stratification Tool for Opioid Risk Mitigation (STORM).,"BACKGROUND


The Veterans Health Administration (VHA) developed a dashboard Stratification Tool for Opioid Risk Mitigation (STROM) to guide clinical practice interventions. VHA released a policy mandating that high-risk patients of an adverse event based on the STORM dashboard are to be reviewed by an interdisciplinary team of clinicians.
AIM


Randomized program evaluation to evaluate if patients in the oversight arm had a lower risk of opioid-related serious adverse events (SAEs) or death compared to those in the non-oversight arm.
SETTING AND PARTICIPANTS


One-hundred and forty VHA facilities (aka medical centers) were randomly assigned to two groups: oversight and non-oversight arms. VHA patients who were prescribed opioids between April 18, 2018, and November 8, 2019, were included in the cohort.
PROGRAM DESCRIPTION


We hypothesized that patients cared for by VHA facilities that received the policy with the oversight accountability language would achieve lower opioid-related SAEs or death.
PROGRAM EVALUATION


We did not observe a relationship between the oversight arm and opioid-related SAEs or death. Patients in the non-oversight arm had a significantly higher chance of receiving a case review compared to those in the oversight arm.
DISCUSSION


Even though our findings were unexpected, the STORM policy overall was likely successful in focusing the provider's attention on very high-risk patients.",2022,"Patients in the non-oversight arm had a significantly higher chance of receiving a case review compared to those in the oversight arm.
","['One-hundred and forty VHA facilities (aka medical centers', 'VHA patients who were prescribed opioids between April 18, 2018, and November 8, 2019, were included in the cohort', 'patients cared for by VHA facilities', 'Veterans Health Administration Stratification Tool for Opioid Risk Mitigation (STORM']",['VHA'],['risk of opioid-related serious adverse events (SAEs) or death'],"[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C2919582', 'cui_str': 'Akan language'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0867291,"Patients in the non-oversight arm had a significantly higher chance of receiving a case review compared to those in the oversight arm.
","[{'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Minegishi', 'Affiliation': 'Partnered Evidence-Based Policy Research Center, VA Boston Healthcare System, 150 South Huntington Avenue, Boston, MA, 02130, USA. taeko.minegishi@va.gov.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Garrido', 'Affiliation': 'Partnered Evidence-Based Policy Research Center, VA Boston Healthcare System, 150 South Huntington Avenue, Boston, MA, 02130, USA.'}, {'ForeName': 'Eleanor T', 'Initials': 'ET', 'LastName': 'Lewis', 'Affiliation': 'Veterans Affairs Program Evaluation and Resource Center, Veterans Affairs Office of Mental Health and Suicide Prevention, Menlo Park, CA, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Oliva', 'Affiliation': 'Veterans Affairs Program Evaluation and Resource Center, Veterans Affairs Office of Mental Health and Suicide Prevention, Menlo Park, CA, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Pizer', 'Affiliation': 'Partnered Evidence-Based Policy Research Center, VA Boston Healthcare System, 150 South Huntington Avenue, Boston, MA, 02130, USA.'}, {'ForeName': 'Kiersten L', 'Initials': 'KL', 'LastName': 'Strombotne', 'Affiliation': 'Partnered Evidence-Based Policy Research Center, VA Boston Healthcare System, 150 South Huntington Avenue, Boston, MA, 02130, USA.'}, {'ForeName': 'Jodie A', 'Initials': 'JA', 'LastName': 'Trafton', 'Affiliation': 'Veterans Affairs Program Evaluation and Resource Center, Veterans Affairs Office of Mental Health and Suicide Prevention, Menlo Park, CA, USA.'}, {'ForeName': 'Kertu', 'Initials': 'K', 'LastName': 'Tenso', 'Affiliation': 'Partnered Evidence-Based Policy Research Center, VA Boston Healthcare System, 150 South Huntington Avenue, Boston, MA, 02130, USA.'}, {'ForeName': 'Pooja S', 'Initials': 'PS', 'LastName': 'Sohoni', 'Affiliation': 'Veterans Affairs Program Evaluation and Resource Center, Veterans Affairs Office of Mental Health and Suicide Prevention, Menlo Park, CA, USA.'}, {'ForeName': 'Austin B', 'Initials': 'AB', 'LastName': 'Frakt', 'Affiliation': 'Partnered Evidence-Based Policy Research Center, VA Boston Healthcare System, 150 South Huntington Avenue, Boston, MA, 02130, USA.'}]",Journal of general internal medicine,['10.1007/s11606-022-07622-1']
2335,35716058,"Cooled Radiofrequency Ablation of Genicular Nerves Provides 24-Month Durability in the Management of Osteoarthritic Knee Pain: Outcomes from a Prospective, Multicenter, Randomized Trial.","OBJECTIVE


To assess long-term outcomes of cooled radiofrequency ablation (CRFA) of genicular nerves for chronic knee pain due to osteoarthritis (OA).
METHODS


A prospective, observational extension of a randomized, controlled trial was conducted on adults randomized to CRFA. Subjects were part of a 12-month clinical trial comparing CRFA of genicular nerves to a single hyaluronic injection for treatment of chronic OA knee pain, who then agreed to visits at 18- and 24-months post CRFA and had not undergone another knee procedure since. The subjects were evaluated for: pain using the Numeric Rating Scale (NRS), function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), subjective benefit using the Global Perceived Effect (GPE) scale, quality of life using the EuroQol-5-Dimensions-5 Level (EQ-5D-5L) questionnaire, and safety.
RESULTS


Of 57 subjects eligible, 36 enrolled; 32 completed the 18-month visit with a mean NRS score of 2.4 and 22 (69%) reporting ≥50% reduction in pain from baseline (primary endpoint); 27 completed the 24-month visit, with a mean NRS of 3.4 and 17 (63%) reporting ≥50% pain relief. Functional and quality of life improvements persisted similarly, with mean changes from baseline of 53.5% and 34.9% in WOMAC total scores, and 24.8% and 10.7% in EQ-5D-5L Index scores, at 18- and 24-months, respectively. There were no identified safety concerns in this patient cohort.
CONCLUSION


In this subset of subjects, CRFA of genicular nerves provided durable pain relief, improved function, and improved quality of life extending to 24 months post procedure, with no significant safety concerns.",2022,"In this subset of subjects, CRFA of genicular nerves provided durable pain relief, improved function, and improved quality of life extending to 24 months post procedure, with no significant safety concerns.","['chronic OA knee pain, who then agreed to visits at 18- and 24-months post CRFA and had not undergone another knee procedure since', ' 36 enrolled; 32 completed the 18-month visit with a mean NRS score of 2.4 and 22 (69%) reporting ≥50% reduction in pain from baseline (primary endpoint); 27 completed the 24-month visit, with a mean NRS of 3.4 and 17 (63%) reporting ≥50% pain relief', 'chronic knee pain due to osteoarthritis (OA', '57 subjects eligible', 'Osteoarthritic Knee Pain']","['Cooled Radiofrequency Ablation of Genicular Nerves', 'cooled radiofrequency ablation (CRFA', 'hyaluronic injection']","['durable pain relief, improved function, and improved quality of life', 'pain using the Numeric Rating Scale (NRS), function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), subjective benefit using the Global Perceived Effect (GPE) scale, quality of life using the EuroQol-5-Dimensions-5 Level (EQ-5D-5L) questionnaire, and safety', 'EQ-5D-5L Index scores', 'Functional and quality of life improvements']","[{'cui': 'C0263778', 'cui_str': 'Chronic osteoarthritis'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C1292892', 'cui_str': 'Procedure on knee'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.092603,"In this subset of subjects, CRFA of genicular nerves provided durable pain relief, improved function, and improved quality of life extending to 24 months post procedure, with no significant safety concerns.","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lyman', 'Affiliation': ""Institute for Orthopedic Research and Innovation, Coeur d'Alene, ID, USA.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Khalouf', 'Affiliation': 'University Orthopedics Center, Altoona, PA, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Zora', 'Affiliation': 'University Orthopedics Center, State College, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DePalma', 'Affiliation': 'Virginia iSpine Physicians, Richmond, VA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Loudermilk', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Guiguis', 'Affiliation': 'Ochsner Clinic Foundation, New Orleans, LA, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Beall', 'Affiliation': 'Clinical Investigations, Edmond, OK, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Kohan', 'Affiliation': 'PCPMG Clinical Research Unit LLC, Anderson, SC, USA.'}, {'ForeName': 'Antonia F', 'Initials': 'AF', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedics, Brigham and Women's Hospital, Boston, MA, USA.""}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.13139']
2336,35715966,The School of Hard Talks: A telehealth parent training group for caregivers of adolescents and young adults.,"AIM


A large body of evidence demonstrates the importance of the family environment in the developmental trajectory of mental illness in young people. Caregiver communication skills training represents a potential model for influencing the outcomes of adolescents and young adults struggling with emerging mental health and behavioural difficulties. The aim of the current study is to describe the development of a telehealth group training intervention for caregivers of adolescents and young adults, and to report the results of a pilot feasibility-effectiveness study that took place in 2020-2021.
METHODS


The ""School of Hard Talks"" intervention consisted of 8 h of training in communication skills consistent with motivational interviewing techniques. All pilot study participants were assigned to receive the intervention. Outcomes of interest were family conflict, caregiver stress, caregiver self-efficacy and expressed emotion (EE). Participants were assessed three times: prior to the intervention, after the intervention and 12 weeks later.
RESULTS


A total of 62 participants enrolled in the study, of whom 49 completed the intervention. Large, significant improvements were observed over time in all four domains of interest. Qualitative feedback from parents was very positive and added context to quantitative observations.
CONCLUSIONS


The School of Hard Talks was a feasible and effective intervention targeting both caregiver wellbeing as well as important mechanisms of risk for youth psychopathology, namely family conflict and EE. Further research involving a larger sample and a control condition are needed to confirm these findings.",2022,"The School of Hard Talks was a feasible and effective intervention targeting both caregiver wellbeing as well as important mechanisms of risk for youth psychopathology, namely family conflict and EE.","['caregivers of adolescents and young adults', '62 participants enrolled in the study, of whom 49 completed the intervention', 'young people', 'adolescents and young adults struggling with emerging mental health and behavioural difficulties', 'The ""School of Hard Talks', 'The School of Hard Talks', '2020-2021']","['telehealth group training intervention', ' intervention consisted of 8\xa0h of training in communication skills consistent with motivational interviewing techniques', 'Caregiver communication skills training']","['family conflict, caregiver stress, caregiver self-efficacy and expressed emotion (EE']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}]","[{'cui': 'C0233542', 'cui_str': 'Family conflict'}, {'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}]",62.0,0.0213069,"The School of Hard Talks was a feasible and effective intervention targeting both caregiver wellbeing as well as important mechanisms of risk for youth psychopathology, namely family conflict and EE.","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Kline', 'Affiliation': 'Department of Psychiatry, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Thibeau', 'Affiliation': 'Department of Psychiatry, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'A Simone', 'Initials': 'AS', 'LastName': 'Sanders', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Beshaun J', 'Initials': 'BJ', 'LastName': 'Davis', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fenley', 'Affiliation': 'Department of Psychology, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'McIntyre', 'Affiliation': ""Children's Behavioral Health Knowledge Center, Massachusetts Department of Mental Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'English', 'Affiliation': ""Children's Behavioral Health Knowledge Center, Massachusetts Department of Mental Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Matcheri S', 'Initials': 'MS', 'LastName': 'Keshavan', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}]",Early intervention in psychiatry,['10.1111/eip.13321']
2337,35715946,Re-adjudication of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) with study-level meta-analysis of hospitalization for heart failure from cardiovascular outcomes trials with dipeptidyl peptidase-4 (DPP-4) inhibitors.,"BACKGROUND


Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) assessed the cardiovascular (CV) safety of sitagliptin versus placebo on CV outcomes in patients with type 2 diabetes and CV disease and found sitagliptin noninferior to placebo. Subsequently, based on feedback from FDA, the Sponsor of the trial, Merck & Co., Inc., engaged a separate academic research organization, the TIMI Study Group, to re-adjudicate a prespecified set of originally adjudicated events.
METHODS


TIMI adjudicated in a blinded fashion all potential hospitalization for heart failure (HHF) events, all potential MACE+ events previously adjudicated as not an endpoint event, and a random subset (~10%) of MACE+ events previously adjudicated as an endpoint event. An updated study-level meta-analysis of four randomized, placebo-controlled, CV outcomes trials with dipeptidyl peptidase 4 (DPP-4) inhibitors was then performed.
RESULTS


After re-adjudication of potential HHF events in the intent-to-treat population, there were 224 patients with a confirmed event in the sitagliptin arm (1.05/100 person-years) and 239 patients in the placebo arm (1.13/100 person-years), corresponding to a hazard ratio (HR) of 0.94 (95% confidence interval [95% CI]: 0.78-1.13, p = .49). Concordance between the outcome of the original adjudication and the re-adjudication for HHF events was 82.7%. The meta-analysis of CV outcomes trials with DPP-4 inhibitors with placebo and involving 43 522 patients yielded an HR of 1.07 (95% CI: 0.83-1.39), with moderate heterogeneity (p = .45, I 2   = 62.07%).
CONCLUSION


The results of this independent re-adjudication process and analyses of CV outcomes from TECOS were consistent with the original adjudication results and overall study findings. An updated study-level meta-analysis showed no overall significant risk for HHF with DPP-4 inhibitors, but with statistical heterogeneity.",2022,"(95% confidence interval [95% CI]: 0.78-1.13, p = .49).","['224 patients with a confirmed event in the sitagliptin arm (1.05/100 person-years) and 239 patients in the', 'patients with type 2 diabetes and CV disease and found sitagliptin noninferior to', 'TIMI adjudicated in a blinded fashion all potential hospitalization for heart failure (HHF) events, all potential MACE+\xa0events previously adjudicated as not an endpoint event, and a random subset (~10%) of MACE+\xa0events previously adjudicated as an endpoint event']","['Sitagliptin (TECOS', 'dipeptidyl peptidase 4 (DPP-4) inhibitors', 'sitagliptin versus placebo', 'dipeptidyl peptidase-4 (DPP-4)\xa0inhibitors', 'placebo']","['cardiovascular (CV) safety', 'potential HHF events']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",43522.0,0.58289,"(95% confidence interval [95% CI]: 0.78-1.13, p = .49).","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'KyungAh', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Dolly A', 'Initials': 'DA', 'LastName': 'Rodriguez', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Green', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical cardiology,['10.1002/clc.23844']
2338,35715934,Erratum to: Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial.,,2022,,['heart failure'],['omecamtiv mecarbil'],[],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C2932035', 'cui_str': 'omecamtiv mecarbil'}]",[],,0.0932282,,[],European heart journal,['10.1093/eurheartj/ehac332']
2339,35716442,Can an online expressive writing program support people with inflammatory bowel disease? A feasibility randomised controlled trial.,"BACKGROUND


We explored feasibility, acceptability and preliminary efficacy of an online writing intervention (WriteforIBD) against an active control condition for distress in people with inflammatory bowel disease (IBD) at the time of the COVID-19 pandemic.
METHODS


A feasibility RCT was conducted in 19 adults (89.5% female, aged 20-69 years) with IBD and mild-moderate distress. Participants allocated to the WriteForIBD group completed a 4-day 30-min writing program adapted for IBD. The active control group wrote about trivial topics provided by researchers. Feasibility was established based on the recruitment and retention while acceptability based on completion rates and a numeric rating scale. All participants completed measures of mental health and disease activity before and after the intervention (one week) and at follow-up three months after the study commencement.
RESULTS


The retention rate in the study was high (100% WriteForIBD; 82% control). All participants attended every session. 84.2% of participants were satisfied with the intervention. All participants reported a significant improvement in IBD-Control immediately after the intervention; F (2, 33.7) = 7.641, p = .002. A significant interaction of group*time for resilience was noted, R 2  = 0.19, p < .001, with the active control group reporting a significant decline in resilience from the first follow-up to three months while no significant change in resilience for the WriteForIBD group was recorded.
CONCLUSIONS


Online expressive writing is potentially feasible and highly acceptable to people with IBD who report distress. Future large-scale trials should explore the intervention that is adapted from this feasibility study.
REGISTRATION


ID: ACTRN12620000448943p.",2022,"All participants reported a significant improvement in IBD-Control immediately after the intervention; F (2, 33.7) = 7.641, p = .002.","['19 adults (89.5% female, aged 20-69 years) with IBD and mild-moderate distress', 'people with inflammatory bowel disease (IBD']","['online writing intervention (WriteforIBD', '4-day 30-min writing program adapted for IBD']","['IBD-Control', 'completion rates and a numeric rating scale', 'retention rate', 'mental health and disease activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",19.0,0.133817,"All participants reported a significant improvement in IBD-Control immediately after the intervention; F (2, 33.7) = 7.641, p = .002.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skvarc', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Subhadra', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Suiyin', 'Initials': 'S', 'LastName': 'Cheah', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Cranney', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'German', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Orr', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia; iMPACT, School of Medicine, Deakin University, Geelong, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Emerson', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Olive', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia; iMPACT, School of Medicine, Deakin University, Geelong, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Beswick', 'Affiliation': 'Department of Gastroenterology, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Massuger', 'Affiliation': ""Crohn's & Colitis Australia, Melbourne, Australia.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Raven', 'Affiliation': ""Crohn's & Colitis Australia, Melbourne, Australia.""}, {'ForeName': 'Antonina', 'Initials': 'A', 'LastName': 'Mikocka-Walus', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia. Electronic address: mikocka@deakin.edu.au.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2022.101616']
2340,35716692,"Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial.","BACKGROUND


The monoclonal antibody eptinezumab, which targets calcitonin gene-related peptide, has shown migraine preventive effects starting the day following infusion and acceptable safety and tolerability in phase 3 trials, but benefits in the subpopulations of patients with previous preventive treatment failures were not examined. We aimed to investigate the safety and efficacy of eptinezumab for migraine prevention in adults with migraine and two-to-four previous preventive treatment failures.
METHODS


DELIVER was a multicentre, multi-arm, phase 3b trial comprising a 24-week double-blind, placebo-controlled period and a 48-week dose-blinded extension. We recruited adults with episodic or chronic migraine with at least 4 monthly migraine days (as per International Headache Society guidelines) and documented evidence of two-to-four previous preventive treatment failures within the past 10 years, from 96 study locations across Europe (n=93) and the USA (n=3). Patients were randomly assigned (1:1:1) via a centralised randomisation system, stratified by baseline monthly headache days and country, to eptinezumab 100 mg, eptinezumab 300 mg, or placebo. The primary efficacy endpoint was the change from baseline in mean monthly migraine days (captured using a daily electronic diary) in weeks 1-12, assessed in the full analysis set. All participants and study personnel were masked to study drug assignments. The dose-blinded extension period is ongoing. The trial is registered with ClinicalTrials.gov, NCT04418765, and EudraCT, 2019-004497-25.
FINDINGS


Between June 1, 2020, and Oct 7, 2021, 891 individuals were randomly assigned and received at least one dose of study drug (safety population; eptinezumab 100 mg n=299 [34%], eptinezumab 300 mg n=294 [33%], placebo n=298 [33%]). 865 patients completed the placebo-controlled period. The change from baseline to weeks 1-12 in mean monthly migraine days was -4·8 (SE 0·37) with eptinezumab 100 mg, -5·3 (0·37) with eptinezumab 300 mg, and -2·1 (0·38) with placebo. The difference from placebo in change in mean monthly migraine days from baseline was significant with eptinezumab 100 mg (-2·7 [95% CI -3·4 to -2·0]; p<0·0001) and eptinezumab 300 mg (-3·2 [-3·9 to -2·5]; p<0·0001). Treatment-emergent adverse events occurred in 127 (42%) of 299 patients in the eptinezumab 100 mg group, in 120 (41%) of 294 in the eptinezumab 300 mg group, and in 119 (40%) of 298 in the placebo group. The most common treatment-emergent adverse event was COVID-19 (20 [7%] of 299 patients in the eptinezumab 100 mg group, 17 [6%] of 294 in the eptinezumab 300 mg group, and 16 [5%] of 298 in the placebo group). Serious adverse events were uncommon (five [2%] of 299 in the eptinezumab 100 mg group, seven [2%] of 294 in the eptinezumab 300 mg group, four [1%] of 298 in the placebo group) and included anaphylactic reaction (eptinezumab 300 mg n=2) and COVID-19 (eptinezumab 100 mg n=1 and eptinezumab 300 mg n=1).
INTERPRETATION


In adults with migraine and two-to-four previous preventive treatment failures, eptinezumab provided significant migraine preventive effects compared with placebo, with acceptable safety and tolerability, indicating that eptinezumab might be an effective treatment option for this patient population. The dose-blinded extension period will provide additional long-term safety data in patients with migraine and previous preventive treatment failures.
FUNDING


H Lundbeck.",2022,"Treatment-emergent adverse events occurred in 127 (42%) of 299 patients in the eptinezumab 100 mg group, in 120 (41%) of 294 in the eptinezumab 300 mg group, and in 119 (40%) of 298 in the placebo group.","['patients with migraine and previous preventive treatment failures', '865 patients completed the', 'patients with two-to-four previous preventive treatment failures (DELIVER', 'Between June 1, 2020, and Oct 7, 2021, 891 individuals', 'adults with migraine and two-to-four previous preventive treatment failures', 'adults with episodic or chronic migraine with at least 4 monthly migraine days (as per International Headache Society guidelines) and documented evidence of two-to-four previous preventive treatment failures within the past 10 years, from 96 study locations across Europe (n=93) and the USA (n=3']","['eptinezumab 300 mg, and -2·1', 'eptinezumab 100 mg, -5·3', 'eptinezumab', 'eptinezumab 100 mg, eptinezumab 300 mg, or placebo', 'placebo']","['adverse events', 'mean monthly migraine days (captured using a daily electronic diary', 'acceptable safety and tolerability', 'anaphylactic reaction', 'Serious adverse events', 'Safety and efficacy', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1310510', 'cui_str': 'POU3F2 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C4694272', 'cui_str': 'eptinezumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",891.0,0.705508,"Treatment-emergent adverse events occurred in 127 (42%) of 299 patients in the eptinezumab 100 mg group, in 120 (41%) of 294 in the eptinezumab 300 mg group, and in 119 (40%) of 298 in the placebo group.","[{'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark. Electronic address: ashina@dadlnet.dk.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lanteri-Minet', 'Affiliation': 'Pain Department and FHU InovPain, Centre Hospitalier Universitaire de Nice, Nice, France; INSERM U1107 Migraine and Trigeminal Pain, Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pozo-Rosich', 'Affiliation': ""Headache Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Department de Medicina, Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ettrup', 'Affiliation': 'H Lundbeck, Copenhagen, Denmark.'}, {'ForeName': 'Cecilie Laurberg', 'Initials': 'CL', 'LastName': 'Christoffersen', 'Affiliation': 'H Lundbeck, Copenhagen, Denmark.'}, {'ForeName': 'Mette Krog', 'Initials': 'MK', 'LastName': 'Josiassen', 'Affiliation': 'H Lundbeck, Copenhagen, Denmark.'}, {'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Phul', 'Affiliation': 'H Lundbeck, Copenhagen, Denmark.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Sperling', 'Affiliation': 'H Lundbeck, Copenhagen, Denmark.'}]",The Lancet. Neurology,['10.1016/S1474-4422(22)00185-5']
2341,35716471,"Metabolomic analysis of Gyejibongnyeong-Hwan for shoulder pain: A randomized, wait-list controlled pilot trial.","BACKGROUND


In Korea, Gyejibongnyeong-Hwan (GBH), a herbal decoction used to treat blood stasis (BS), is widely used to treat shoulder pain in clinics. Nevertheless, the therapeutic mechanism of GBH in alleviating shoulder pain has not yet been elucidated.
PURPOSE


In this study, we applied mass spectrometry-based metabolomics to explore the therapeutic mechanism of GBH in BS-induced shoulder pain.
STUDY DESIGN


We conducted a two-center, randomized, wait-list controlled pilot trial to explore the therapeutic effect of GBH on shoulder discomfort related to BS.
METHODS


A total of 40 participants with shoulder pain were randomly assigned to either the immediate treatment (GBH-Treat; n = 20) or waiting treatment (Wait-List; n = 20) group. A non-targeted metabolomics approach was then applied to investigate the therapeutic mechanism of GBH.
RESULTS


After 8 weeks of treatment, the visual analog scale (VAS) scores for shoulder pain decreased significantly in the GBH-Treat and Wait-List groups compared with baseline VAS scores (p = 0.004 and p = 0.013, respectively). However, the VAS and BS scores were significantly more reduced in the GBH-Treat group than in the Wait-List group. The plasma metabolic pattern between GBH-Treat and Wait-List groups also differed significantly, which was shown by the score plot of a partial least-squared-discriminant analysis (R 2  = 0.806 and Q 2  = 0.229, p = 0.016). Arginine, bilirubin, carnitine, glutamine, maltol, mystic acid, N,N dimethylarginine, trimethylamine N-oxide, valine, kynurenine, and linoleic acid significantly contributed to the different metabolic patterns between the GBH-Treat and Wait-List groups (all p < 0.05). Pathway analysis revealed that these metabolites were involved in arginine biosynthesis and tryptophan metabolism, which are related to pain generation and transmission. We also confirmed that the ratio of kynurenine to tryptophan, one of the indicators for chronic pain and neuro-inflammation, was significantly lower in the GBH-Treat group than in the Wait-List group (p = 0.02).
CONCLUSION


These results demonstrated that GBH may be a potential treatment option for shoulder pain, and it acts by regulating metabolic patterns. In particular, our study provides evidence for the use of GBH treatment for patients with should pain caused by BS, and we believe that our findings can provide evidence for precision medicine based on traditional Chinese medicine (TCM) or traditional Korean medicine (TKM). We also verified that metabolomics studies provide comprehensive understanding of herbal decoctions in TCM or TKM.",2022,"After 8 weeks of treatment, the visual analog scale (VAS) scores for shoulder pain decreased significantly in the GBH-Treat and Wait-List groups compared with baseline VAS scores (p = 0.004 and p = 0.013, respectively).","['patients with should pain caused by BS', 'for shoulder pain', 'A total of 40 participants with shoulder pain']","['immediate treatment (GBH-Treat; n\xa0=\xa020) or waiting treatment', 'GBH', 'Gyejibongnyeong-Hwan']","['Arginine, bilirubin, carnitine, glutamine, maltol, mystic acid, N,N dimethylarginine, trimethylamine N-oxide, valine, kynurenine, and linoleic acid', 'VAS and BS scores', 'visual analog scale (VAS) scores for shoulder pain', 'chronic pain and neuro-inflammation', 'plasma metabolic pattern']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0065605', 'cui_str': 'maltol'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0067305', 'cui_str': ""N,N'-dimethylarginine""}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0022818', 'cui_str': 'Kynurenine'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",40.0,0.0571756,"After 8 weeks of treatment, the visual analog scale (VAS) scores for shoulder pain decreased significantly in the GBH-Treat and Wait-List groups compared with baseline VAS scores (p = 0.004 and p = 0.013, respectively).","[{'ForeName': 'Mi Mi', 'Initials': 'MM', 'LastName': 'Ko', 'Affiliation': 'Korea Medicine Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 34054, Republic of Korea.'}, {'ForeName': 'Jeeyoun', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Korea Medicine Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 34054, Republic of Korea. Electronic address: jjy0918@kiom.re.kr.'}, {'ForeName': 'Jung-Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Korea Medicine Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 34054, Republic of Korea; Pharmaceutical Analysis Team, International Scientific Standards, Chuncheon 24232, Republic of Korea.'}, {'ForeName': 'Seon Mi', 'Initials': 'SM', 'LastName': 'Shin', 'Affiliation': 'Internal Medicine, College of Korean Medicine, Semyung University, Jecheon 27136, Republic of Korea.'}, {'ForeName': 'Hyun-Kyung', 'Initials': 'HK', 'LastName': 'Sung', 'Affiliation': 'Department of Pediatrics, College of Korean Medicine, Semyung University, Jecheon 27136, Republic of Korea.'}, {'ForeName': 'Ho-Yeon', 'Initials': 'HY', 'LastName': 'Go', 'Affiliation': 'Internal Medicine, College of Korean Medicine, Semyung University, Jecheon 27136, Republic of Korea.'}, {'ForeName': 'Soobin', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Korea Medicine Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 34054, Republic of Korea. Electronic address: suebin@nate.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2022.154248']
2342,35717200,Effect of new biological patch in repairing intrauterine adhesion and improving clinical pregnancy outcome in infertile women: study protocol for a randomized controlled trial.,"BACKGROUND


Endometrial fibrosis caused by intrauterine adhesion (IUA) can lead to hypomenorrhea, amenorrhea, and even infertility and abortion. The postoperative recurrence rate of severe IUA remains high, giving rise to low pregnancy rates. An extracellular matrix (ECM) scaffold, a new biological material that can promote cell proliferation and differentiation at lesions, has been widely used in general surgery and neurosurgery. The present study applied ECM scaffolds in obstetrics and gynecology for the first time to improve endometrial fibrosis, repair severe IUA, and improve pregnancy outcomes for infertile patients.
METHODS


This paper presents a prospective randomized single-blind controlled superiority study of infertile women aged ≤40 years with IUA. According to the scoring criteria for IUA established by the American Fertility Society, patients with moderate or severe IUA were randomized into two groups at a ratio of 1:1; patients in the experimental group were treated with an ECM scaffold (small intestinal submucosa [SIS]) + intrauterine balloon, while patients in the control group were treated with an intrauterine balloon only. A hysteroscopic examination of adhesion repair was performed again after 2 months of postoperative hormone replacement therapy. Endometrial tissue was sampled during the two operations, and immunohistochemistry was used to observe endometrial and microvascular proliferation. After thawing and resuscitation, a postoperative frozen embryo transfer was performed on the participants in both groups, and their endometrial thickness, intrauterine volume, endometrial vascularization flow index, endometrial flow index, and uterine artery blood flow resistance were evaluated by 3D ultrasonography. The rates of embryo implantation, clinical pregnancy, and early spontaneous abortion were observed.
DISCUSSION


The ECM scaffold (SIS) + intrauterine balloon method was able to repair endometrial fibrosis and improve IUA. This new technique represents a novel treatment method for improving the pregnancy outcome of infertile patients with moderate/severe IUA.
TRIAL REGISTRATION


Chinese Clinical Trial Register ChiCTR2100052027 . Registered on October 14, 2021.",2022,"This new technique represents a novel treatment method for improving the pregnancy outcome of infertile patients with moderate/severe IUA.
","['infertile women aged ≤40 years with IUA', 'patients with moderate or severe IUA', 'infertile patients with moderate/severe IUA', 'infertile women', 'infertile patients']","['ECM scaffold (small intestinal submucosa [SIS]) + intrauterine balloon', 'intrauterine balloon only', 'new biological patch']","['postoperative recurrence rate of severe IUA', 'Endometrial tissue', 'rates of embryo implantation, clinical pregnancy, and early spontaneous abortion', 'postoperative frozen embryo transfer', 'repair endometrial fibrosis and improve IUA', 'clinical pregnancy outcome', 'endometrial thickness, intrauterine volume, endometrial vascularization flow index, endometrial flow index, and uterine artery blood flow resistance']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0015350', 'cui_str': 'Matrix, Extracellular'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0227268', 'cui_str': 'Small intestine submucosa'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0029976', 'cui_str': 'Implantation in uterus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0420186,"This new technique represents a novel treatment method for improving the pregnancy outcome of infertile patients with moderate/severe IUA.
","[{'ForeName': 'Wen-Juan', 'Initials': 'WJ', 'LastName': 'Pang', 'Affiliation': 'Reproductive Medicine Center, Second Affiliated Hospital of Naval Medical University, No. 415 of Fengyang Road, Huangpu District, Shanghai, 200003, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, No. 910 of Hengshan Road, Xuhui District, Shanghai, 200030, China.'}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Ding', 'Affiliation': 'International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, No. 910 of Hengshan Road, Xuhui District, Shanghai, 200030, China.'}, {'ForeName': 'Ning-Xia', 'Initials': 'NX', 'LastName': 'Sun', 'Affiliation': 'Reproductive Medicine Center, Second Affiliated Hospital of Naval Medical University, No. 415 of Fengyang Road, Huangpu District, Shanghai, 200003, China. sunningxiaa@126.com.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, No. 910 of Hengshan Road, Xuhui District, Shanghai, 200030, China. liwenlwliwen@163.com.'}]",Trials,['10.1186/s13063-022-06428-0']
2343,35717193,Defining optimal implementation packages for delivering community-wide mass drug administration for soil-transmitted helminths with high coverage.,"BACKGROUND


Recent evidence suggests that community-wide mass drug administration (MDA) may interrupt the transmission of soil-transmitted helminths (STH), a group of intestinal worms that infect 1.5 billion individuals globally. Although current operational guidelines provide best practices for effective MDA delivery, they do not describe which activities are most essential for achieving high coverage or how they work together to produce effective intervention delivery. We aimed to identify the various packages of influential intervention delivery activities that result in high coverage of community-wide MDA for STH in Benin, India, and Malawi.
METHODS


We applied coincidence analysis (CNA), a novel cross-case analytical method, to process mapping data as part of the implementation science research of the DeWorm3 Project, a Hybrid Type 1 cluster randomized controlled trial assessing the feasibility of interrupting the transmission of STH using bi-annual community-wide MDA in Benin, India, and Malawi. Our analysis aimed to identify any necessary and/or sufficient combinations of intervention delivery activities (i.e., implementation pathways) that resulted in high MDA coverage. Activities were related to drug supply chain, implementer training, community sensitization strategy, intervention duration, and implementation context. We used pooled implementation data from three sites and six intervention rounds, with study clusters serving as analytical cases (N = 360). Secondary analyses assessed differences in pathways across sites and over intervention rounds.
RESULTS


Across all three sites and six intervention rounds, efficient duration of MDA delivery (within ten days) singularly emerged as a common and fundamental component for achieving high MDA coverage when combined with other particular activities, including a conducive implementation context, early arrival of albendazole before the planned start of MDA, or a flexible community sensitization strategy. No individual activity proved sufficient by itself for producing high MDA coverage. We observed four possible overall models that could explain effective MDA delivery strategies, all which included efficient duration of MDA delivery as an integral component.
CONCLUSION


Efficient duration of MDA delivery uniquely stood out as a highly influential implementation activity for producing high coverage of community-wide MDA for STH. Effective MDA delivery can be achieved with flexible implementation strategies that include various combinations of influential intervention components.",2022,"Across all three sites and six intervention rounds, efficient duration of MDA delivery (within ten days) singularly emerged as a common and fundamental component for achieving high MDA coverage when combined with other particular activities, including a conducive implementation context, early arrival of albendazole before the planned start of MDA, or a flexible community sensitization strategy.",[],[],['efficient duration of MDA delivery'],[],[],"[{'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",,0.0248141,"Across all three sites and six intervention rounds, efficient duration of MDA delivery (within ten days) singularly emerged as a common and fundamental component for achieving high MDA coverage when combined with other particular activities, including a conducive implementation context, early arrival of albendazole before the planned start of MDA, or a flexible community sensitization strategy.","[{'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Gwayi-Chore', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA. cgwayi@uw.edu.'}, {'ForeName': 'Kumudha', 'Initials': 'K', 'LastName': 'Aruldas', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}, {'ForeName': 'Euripide', 'Initials': 'E', 'LastName': 'Avokpaho', 'Affiliation': 'Institut de Recherche Clinique du Benin, Abomey-Calavi, Benin.'}, {'ForeName': 'Chawanangwa Maherebe', 'Initials': 'CM', 'LastName': 'Chirambo', 'Affiliation': 'Blantyre Institute for Community Outreach (BICO), Lions Sight First Eye Hospital, Blantyre, Malawi.'}, {'ForeName': 'Saravanakumar Puthupalayam', 'Initials': 'SP', 'LastName': 'Kaliappan', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}, {'ForeName': 'Parfait', 'Initials': 'P', 'LastName': 'Houngbégnon', 'Affiliation': 'Institut de Recherche Clinique du Benin, Abomey-Calavi, Benin.'}, {'ForeName': 'Comlanvi Innocent', 'Initials': 'CI', 'LastName': 'Togbevi', 'Affiliation': 'Institut de Recherche Clinique du Benin, Abomey-Calavi, Benin.'}, {'ForeName': 'Félicien', 'Initials': 'F', 'LastName': 'Chabi', 'Affiliation': 'Institut de Recherche Clinique du Benin, Abomey-Calavi, Benin.'}, {'ForeName': 'Providence', 'Initials': 'P', 'LastName': 'Nindi', 'Affiliation': 'Blantyre Institute for Community Outreach (BICO), Lions Sight First Eye Hospital, Blantyre, Malawi.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Simwanza', 'Affiliation': 'Blantyre Institute for Community Outreach (BICO), Lions Sight First Eye Hospital, Blantyre, Malawi.'}, {'ForeName': 'Jabaselvi', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Miech', 'Affiliation': 'Center for Health Services Research, Regenstrief Institute, Indianapolis, USA.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach (BICO), Lions Sight First Eye Hospital, Blantyre, Malawi.'}, {'ForeName': 'Moudachirou', 'Initials': 'M', 'LastName': 'Ibikounlé', 'Affiliation': 'Institut de Recherche Clinique du Benin, Abomey-Calavi, Benin.'}, {'ForeName': 'Sitara S R', 'Initials': 'SSR', 'LastName': 'Ajjampur', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Weiner', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Judd L', 'Initials': 'JL', 'LastName': 'Walson', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Arianna Rubin', 'Initials': 'AR', 'LastName': 'Means', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}]",BMC health services research,['10.1186/s12913-022-08080-5']
2344,35717169,Effects of sacubitril/valsartan on glycemia in patients with diabetes and heart failure: the PARAGON-HF and PARADIGM-HF trials.,"BACKGROUND


Compared with enalapril, sacubitril/valsartan lowered HbA1c and reduced new insulin therapy in patients with heart failure with reduced ejection fraction (HFrEF) and diabetes in the PARADIGM-HF trial. We sought to assess the glycemic effects of sacubitril/valsartan in heart failure with preserved ejection fraction (HFpEF) and diabetes, and across the spectrum of left ventricular ejection fraction (LVEF) in heart failure and diabetes.
METHODS


We compared the effect of sacubitril/valsartan, relative to valsartan, on HbA1c, new insulin therapy and hypoglycemia in the randomized controlled trial PARAGON-HF, and performed pooled analyses of PARAGON-HF and PARADIGM-HF.
RESULTS


Among 2395 patients with HFpEF and diabetes in PARAGON-HF, sacubitril/valsartan compared with valsartan reduced HbA1c (baseline-adjusted between-group difference in HbA1c change at 48 weeks: - 0.24%, 95% CI - 0.33 to - 0.16%, P < 0.001). Numerically, new insulin treatment was initiated less often in the sacubitril/valsartan group than in the valsartan group, but the difference was not statistically significant (12.8% vs. 16.1%; HR: 0.80, 95% CI 0.62-1.02, P = 0.07). Hypoglycemia adverse event reports were low, but more frequent in those receiving sacubitril/valsartan than in the valsartan group (4.2% vs. 2.6%; HR: 1.64, 95% CI 1.05-2.56, P = 0.030). In a pooled analysis of PARAGON-HF and PARADIGM-HF, the effect of sacubitril/valsartan on change in HbA1c was not significantly modified by LVEF (P interaction  = 0.56). Across the spectrum of LVEF, sacubitril/valsartan reduced new insulin therapy (HR: 0.75, 95% CI 0.63-0.89, P = 0.001), compared with enalapril or valsartan.
CONCLUSIONS


Sacubitril/valsartan reduced HbA1c and new insulin therapy in patients with heart failure and diabetes across the spectrum of LVEF but may be associated with a slightly higher risk for hypoglycemia. Trial registration ClinicalTrials.gov NCT01920711.",2022,"Across the spectrum of LVEF, sacubitril/valsartan reduced new insulin therapy (HR: 0.75, 95% CI 0.63-0.89, P = 0.001), compared with enalapril or valsartan.
","['patients with heart failure and diabetes', '2395 patients with HFpEF and diabetes', 'patients with heart failure with reduced ejection fraction (HFrEF) and diabetes', 'patients with diabetes and heart failure']","['Sacubitril/valsartan', 'sacubitril/valsartan, relative to valsartan', 'valsartan', 'enalapril', 'enalapril, sacubitril/valsartan', 'sacubitril/valsartan']",['Hypoglycemia adverse'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",2395.0,0.206482,"Across the spectrum of LVEF, sacubitril/valsartan reduced new insulin therapy (HR: 0.75, 95% CI 0.63-0.89, P = 0.001), compared with enalapril or valsartan.
","[{'ForeName': 'Magnus O', 'Initials': 'MO', 'LastName': 'Wijkman', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Cunningham', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Rørth', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis, East Hanover, NJ, USA.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA. ssolomon@bwh.harvard.edu.""}]",Cardiovascular diabetology,['10.1186/s12933-022-01545-1']
2345,35717166,"Predictive value of baseline metabolic tumor volume in early-stage favorable Hodgkin Lymphoma - Data from the prospective, multicenter phase III HD16 trial.","BACKGROUND


18 F -fluorodeoxyglucose (FDG) positron emission tomography (PET) plays an important role in the staging and response assessment of lymphoma patients. Our aim was to explore the predictive relevance of metabolic tumor volume (MTV) and total lesion glycolysis (TLG) in patients with early stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD16 trial.
METHODS


18 F-FDG PET/CT images were available for MTV and TLG analysis in 107 cases from the HD16 trial. We calculated MTV and TLG using three different threshold methods (SUV 4.0,  SUV 41%  and SUV 140%L ), and then performed receiver-operating-characteristic analysis to assess the predictive impact of these parameters in predicting an adequate therapy response with PET negativity after 2 cycles of chemotherapy.
RESULTS


All three threshold methods analyzed for MTV and TLG calculation showed a positive correlation with the PET response after 2 cycles chemotherapy. The largest area under the curve (AUC) was observed using the fixed threshold of SUV 4.0  for MTV- calculation (AUC 0.69 [95% CI 0.55-0.83]) and for TLG-calculation (AUC 0.69 [0.55-0.82]). The calculations for MTV and TLG with a relative threshold showed a lower AUC: using SUV 140%L  AUCs of 0.66 [0.53-0.80] for MTV and 0.67 for TLG [0.54-0.81]) were observed, while with SUV 41%  an AUC of 0.61 [0.45-0.76] for MTV, and an AUC 0.64 [0.49-0.80]) for TLG were seen.
CONCLUSIONS


MTV and TLG do have a predictive value after two cycles ABVD in early stage Hodgkin lymphoma, particularly when using the fixed threshold of SUV 4.0  for MTV and TLG calculation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00736320 .",2022,All three threshold methods analyzed for MTV and TLG calculation showed a positive correlation with the PET response after 2 cycles chemotherapy.,"['lymphoma patients', '18 F-FDG PET/CT images were available for MTV and TLG analysis in 107 cases from the HD16 trial', 'patients with early stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD16 trial']","['MTV and TLG', '18 F -fluorodeoxyglucose (FDG) positron emission tomography (PET', 'total lesion glycolysis (TLG']","['PET response', 'largest area under the curve (AUC']","[{'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0017952', 'cui_str': 'Glycolysis'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",107.0,0.11594,All three threshold methods analyzed for MTV and TLG calculation showed a positive correlation with the PET response after 2 cycles chemotherapy.,"[{'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'van Heek', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany. lutz.van-heek@uk-koeln.de.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Stuka', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kaul', 'Affiliation': 'First Department of Internal Medicine and German Hodgkin Study Group (GHSG), Center for Integrated Oncology Aachen - Bonn - Cologne - Düsseldorf (CIO ABCD), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'First Department of Internal Medicine and German Hodgkin Study Group (GHSG), Center for Integrated Oncology Aachen - Bonn - Cologne - Düsseldorf (CIO ABCD), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Mettler', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Hitz', 'Affiliation': 'Swiss Group for Clinical Cancer Research, Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baues', 'Affiliation': 'Department of Radiation Oncology and Cyberknife Center, Faculty of Medicine and UniversityHospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'First Department of Internal Medicine and German Hodgkin Study Group (GHSG), Center for Integrated Oncology Aachen - Bonn - Cologne - Düsseldorf (CIO ABCD), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'First Department of Internal Medicine and German Hodgkin Study Group (GHSG), Center for Integrated Oncology Aachen - Bonn - Cologne - Düsseldorf (CIO ABCD), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'First Department of Internal Medicine and German Hodgkin Study Group (GHSG), Center for Integrated Oncology Aachen - Bonn - Cologne - Düsseldorf (CIO ABCD), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Dietlein', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.'}, {'ForeName': 'Conrad-Amadeus', 'Initials': 'CA', 'LastName': 'Voltin', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Kobe', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.'}]",BMC cancer,['10.1186/s12885-022-09758-z']
2346,35717156,Acceptability and impact of group interpersonal therapy (IPT-G) on Kenyan adolescent mothers living with human immunodeficiency virus (HIV): a qualitative analysis.,"BACKGROUND


Task shifting is a well-tested implementation strategy within low- and middle-income countries that addresses the shortage of trained mental health personnel. Task shifting can increase access to care for patients with mental illnesses. In Kenya, community health workers (CHWs) are a combination of community health assistants and community health volunteers and have played a crucial role on this front. In our study, we seek to assess the acceptability and feasibility of Group Interpersonal Psychotherapy (IPT-G) delivered by CHWs among depressed postpartum adolescents (PPAs) living with human immunodeficiency virus (HIV).
METHOD


The study used theoretical framework of behaviour change including: Capability, Opportunity and Motivation (COM-B model) to help understand behavioural changes due to IPT-G intervention delivered by the CHWs. 24 PPAs were administered IPT-G by trained CHWs from two health centres. A two-arm study design (IPT-G intervention and treatment as usual) with an intent to treat was used to assess the acceptability and feasibility of IPT-G. With purposeful sampling, participants who scored > 10 on the Edinburgh postnatal depression scale and who were 6-12 weeks postpartum were eligible for the study. Participants were equally distributed into two groups: one group for intervention and another as a wait-listed group. This was achieved by randomly allocating numerical numbers and separating those with odd numbers (intervention group) and even numbers (wait-listed group). Focus group discussions and in-depth interviews ascertained the experiences and perceptions of the PPAs and the CHWs during IP-G delivery process. In addition to weekly face-to-face continuous supportive supervision for the CHWs, the researchers also utilized phone calls, short messages services and WhatsApp instant messaging services.
RESULTS


The CHWs found the intervention useful for their own knowledge and skill-set. With regards to participation, 21 out of the 24 adolescents attended all sessions. Most of the adolescents reported an improvement in their interpersonal relationships with reduced distress and lessening of HIV-related stigma. Primary healthcare workers embraced the intervention by accommodating the sessions in their routine clinic activities.
CONCLUSION


Our study demonstrates the possible benefits of task shifting in addressing mental health problems within low-resource settings in Kenya, and IPT-G is demonstrated to be both acceptable and feasible by health workers and adolescents receiving care.",2022,Focus group discussions and in-depth interviews ascertained the experiences and perceptions of the PPAs and the CHWs during IP-G delivery process.,"['patients with mental illnesses', 'Kenyan adolescent mothers living with human immunodeficiency virus (HIV', '24 adolescents attended all sessions', 'In Kenya, community health workers (CHWs', 'depressed postpartum adolescents (PPAs) living with human immunodeficiency virus (HIV', 'participants who scored\u2009>\u200910 on the Edinburgh postnatal depression scale and who were 6-12\xa0weeks postpartum were eligible for the study']","['Motivation (COM-B model', 'group interpersonal therapy (IPT-G', 'Group Interpersonal Psychotherapy (IPT-G) delivered by CHWs']","['distress and lessening of HIV-related stigma', 'acceptability and feasibility', 'acceptability and feasibility of IPT-G']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009490', 'cui_str': 'Comoros islands'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]",24.0,0.023515,Focus group discussions and in-depth interviews ascertained the experiences and perceptions of the PPAs and the CHWs during IP-G delivery process.,"[{'ForeName': 'Obadia', 'Initials': 'O', 'LastName': 'Yator', 'Affiliation': 'Department of Psychiatry, School of Medicine, College of Health Sciences, University of Nairobi, P. O. Box 799-00517, Nairobi, Kenya. obadiayator@gmail.com.'}, {'ForeName': 'Lincoln', 'Initials': 'L', 'LastName': 'Khasakhala', 'Affiliation': 'Department of Psychiatry, University of Nairobi, P. O. Box 30197-00100, Nairobi, Kenya.'}, {'ForeName': 'Grace-John', 'Initials': 'GJ', 'LastName': 'Stewart', 'Affiliation': 'University of Washington, 325 9th Avenue, Box 359909, Seattle, WA, 98104, USA.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, University of Nairobi, P.O. Box 47074-00100, Nairobi, Kenya.'}]",BMC women's health,['10.1186/s12905-022-01807-w']
2347,35717148,Comparison between erector spinae plane block and paravertebral block regarding postoperative analgesic consumption following breast surgery: a randomized controlled study.,"BACKGROUND


Pain control following breast surgery is of utmost importance in order to reduce the chance of chronic pain development, and facilitate early rehabilitation. The erector spinae plane block (ESPB) is a recently developed regional anaesthesia procedure successfully used for different types of surgical procedures including thoracic and abdominal surgeries.
METHODS


A double-blind, randomized, controlled trial was conducted on 90 patients who were scheduled for modified radical mastectomy (MRM). Patients were randomly categorized into groups I (women who underwent ESPB), II (women who underwent paravertebral block (PVB), and III (women who underwent general anaesthesia).
RESULTS


The ESPB (4.9 ± 1.2 mg) and PVB (5.8 ± 1.3 mg) groups had significantly lower total morphine consumption than the control group had (16.4 ± 3.1 mg; p < 0.001). Notably, patients in the ESPB group had insignificantly lower morphine consumption than those in the PVB group had (p = 0.076). Moreover, patients in the ESPB and PVB groups had a significantly longer time to first required anaesthesia than those in the control group (7.9 ± 1.2 versus 7.5 ± 0.9 versus 2 ± 1.2 h, respectively; p < 0.001). The postoperative visual analog scale scores were lower in the ESPB and PVB groups than in the control group on the first 24 h after the procedure (p < 0.001).
CONCLUSION


ESPB and PVB provide effective postoperative analgesia for women undergoing MRM. The ESPB appears to be as effective as the PVB.
TRIAL REGISTRATION


The study was registered before the enrolment of the first patient at the Pan African Clinical Trial Registry ( www.pactr.org ) database. Identification number for the registry is (PACTR202008836682092).",2022,"The postoperative visual analog scale scores were lower in the ESPB and PVB groups than in the control group on the first 24 h after the procedure (p < 0.001).
","['Patients were randomly categorized into groups I (women who underwent ESPB), II (women who underwent\xa0paravertebral block (PVB), and III (women who underwent general anaesthesia', '90 patients who were scheduled for', 'women undergoing MRM', 'breast surgery']","['modified radical mastectomy (MRM', 'ESPB and PVB', 'PVB', 'erector spinae plane block and paravertebral block', 'ESPB']","['PVB', 'postoperative visual analog scale scores', 'total morphine consumption', 'longer time to first required anaesthesia', 'morphine consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}]","[{'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0072634', 'cui_str': 'PVB protocol'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}]","[{'cui': 'C0072634', 'cui_str': 'PVB protocol'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",90.0,0.244849,"The postoperative visual analog scale scores were lower in the ESPB and PVB groups than in the control group on the first 24 h after the procedure (p < 0.001).
","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elewa', 'Affiliation': 'Department of anaesthesia, critical care and pain management, Faculty of Medicine, Suez Canal University, Ard Elgameiat, Ismailia, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Faisal', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Sjöberg', 'Affiliation': 'Department of Biomedical and Clinical Sciences (BKV), Linköping University Hospital, Linköping, Sweden.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Abuelnaga', 'Affiliation': 'Department of anaesthesia, critical care and pain management, Faculty of Medicine, Suez Canal University, Ard Elgameiat, Ismailia, Egypt. Mohamed_abuelnga@med.suez.edu.eg.'}]",BMC anesthesiology,['10.1186/s12871-022-01724-3']
2348,35717146,Protocol for a randomised controlled trial of a family strengthening program to prevent unhealthy weight gain among 5 to 11-year-old children from at-risk families: the Strong Families Trial.,"BACKGROUND


Obesity is an increasing health concern in Australia among adult and child populations alike and is often associated with other serious comorbidities. While the rise in the prevalence of childhood obesity has plateaued in high-income countries, it continues to increase among children from disadvantaged and culturally diverse backgrounds. The family environment of disadvantaged populations may increase the risk of childhood obesity through unhealthy eating and lifestyle practices. The Strong Families Trial aims to assess the effectiveness of a mixed behavioural and lifestyle intervention for parents and carers of at-risk populations, i.e. families from culturally diverse and disadvantaged backgrounds, in preventing unhealthy weight gain among children aged 5 to 11 years.
METHODS


Eight hundred families from low socio-economic areas in Greater Western Sydney, NSW, and Melbourne, VIC, will be recruited and randomised into a lifestyle intervention or control group. The intervention comprises 90-minute weekly sessions for 6 weeks (plus two-booster sessions) of an integrated, evidence-based, parenting and lifestyle program that accounts for the influences of family functioning. Primary (anthropometric data) and secondary (family functioning, feeding related parenting, physical activity, consumption of healthy foods, health literacy, family and household costs) outcome measures will be assessed at baseline, immediately following the intervention, and 12 months post-intervention.
DISCUSSION


This study will elucidate methods for engaging socially disadvantaged and culturally diverse groups in parenting programs concerned with child weight status.
TRIAL REGISTRATION


This study is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12619001019190 ). Registered 16 July 2019.",2022,"The Strong Families Trial aims to assess the effectiveness of a mixed behavioural and lifestyle intervention for parents and carers of at-risk populations, i.e. families from culturally diverse and disadvantaged backgrounds, in preventing unhealthy weight gain among children aged 5 to 11 years.
","['children aged 5 to 11 years', 'Eight hundred\xa0families from low socio-economic areas in Greater Western Sydney, NSW, and Melbourne, VIC, will be recruited and randomised into a\xa0lifestyle\xa0intervention or control group', '5 to 11-year-old children from at-risk families', 'engaging socially disadvantaged and culturally diverse groups in parenting programs concerned with child weight status', 'parents and carers of at-risk populations, i.e. families from culturally diverse and disadvantaged backgrounds']","['mixed behavioural and lifestyle intervention', 'family strengthening program']","['unhealthy weight gain', 'Primary (anthropometric data) and secondary (family functioning, feeding related parenting, physical activity, consumption of healthy foods, health literacy, family and household costs) outcome measures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0242444', 'cui_str': 'Populations at Risk'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0015578', 'cui_str': 'Family and Household'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",,0.115459,"The Strong Families Trial aims to assess the effectiveness of a mixed behavioural and lifestyle intervention for parents and carers of at-risk populations, i.e. families from culturally diverse and disadvantaged backgrounds, in preventing unhealthy weight gain among children aged 5 to 11 years.
","[{'ForeName': 'Cristy', 'Initials': 'C', 'LastName': 'Brooks', 'Affiliation': 'Translational Health Research Institute, School of Medicine, Western Sydney University, Sydney, NSW, Australia. c.brooks@westernsydney.edu.au.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Helson', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Madalyn', 'Initials': 'M', 'LastName': 'McCormack', 'Affiliation': 'Translational Health Research Institute, School of Medicine, Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Baur', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Gill', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Baki', 'Initials': 'B', 'LastName': 'Billah', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cronin', 'Affiliation': 'University of Technology, Sydney, NSW, Australia.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Johar', 'Affiliation': 'Western Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Plaskett', 'Affiliation': 'Western Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Nolan', 'Affiliation': 'Western Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Latanik', 'Affiliation': 'Western Sydney Local Health District, Sydney, NSW, Australia.'}, {'ForeName': 'Andre M N', 'Initials': 'AMN', 'LastName': 'Renzaho', 'Affiliation': 'Translational Health Research Institute, School of Medicine, Western Sydney University, Sydney, NSW, Australia.'}]",BMC public health,['10.1186/s12889-022-13452-x']
2349,35717050,ECOG-ACRIN Guideline for Contouring and Treatment of Early Stage Anal Cancer Using IMRT/IGRT.,"PURPOSE


Previous anal cancer guidelines delineate target volumes similarly for all patients with squamous cell carcinoma of the anal canal and/or perianal skin (SCCA), regardless of disease stage. The purpose of this guideline is to provide customized radiation treatment recommendations for early stage (T1-2 N0 M0) anal cancer treated with intensity modulated and image guided radiation therapy (RT).
METHODS AND MATERIALS


A contouring atlas and radiation treatment recommendations for the ongoing, randomized phase II trial of deintensified chemoradiation for early stage SCCA (EA2182) was created by an expert panel of radiation oncologists. A literature search was conducted to update and expand these recommendations into a guideline for routine clinical use.
RESULTS


For the majority of cases, we recommend treatment in the supine, frog leg position with the use of a customized immobilization device and daily image guided RT to ensure optimal bone and soft tissue alignment. Vaginal dilators can be used daily during RT to maximize genitalia sparing. We recommend use of a 10-mm margin on the gross tumor plus including the anal complex to create the primary clinical target volume. To define the elective lymph node clinical target volume, we recommend starting with a 7-mm expansion on blood vessels, but then further refining these volumes based on the anatomic location. A 5- to 10-mm planning target volume (PTV) margin is suggested based on institutional setup and patient-specific factors. When using a simultaneous integrated boost technique, a dose of 50.4 Gy to primary PTV and 42 Gy to lymph node PTV, both delivered over 28 fractions, with chemotherapy is appropriate for early stage anal cancer.
CONCLUSIONS


This guideline provides anatomic, clinical, and technical instructions to guide radiation oncologists in the planning and delivery of intensity modulated and image guided RT for early stage SCCA.",2022,"When using a simultaneous integrated boost technique, a dose of 50.4 Gy to primary PTV and 42 Gy to lymph node PTV, both delivered over 28 fractions, with chemotherapy is appropriate for early stage anal cancer.
","['patients with squamous cell carcinoma of the anal canal and/or perianal skin (SCCA), regardless of disease stage', 'early stage (T1-2 N0 M0) anal cancer treated with']","['intensity modulated and image guided radiation therapy (RT', 'deintensified chemoradiation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0227411', 'cui_str': 'Anal canal structure'}, {'cui': 'C0442158', 'cui_str': 'Perianal'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0153446', 'cui_str': 'Malignant tumor of anus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C3179062', 'cui_str': 'Image-Guided Radiation Therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]",[],,0.029268,"When using a simultaneous integrated boost technique, a dose of 50.4 Gy to primary PTV and 42 Gy to lymph node PTV, both delivered over 28 fractions, with chemotherapy is appropriate for early stage anal cancer.
","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Damico', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Prajnan', 'Initials': 'P', 'LastName': 'Das', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'UC San Diego Moores Cancer Center, San Diego, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Koontz', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hall', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McBride', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts and ECOG-ACRIN Biostatistics Center.'}, {'ForeName': 'A Bapsi', 'Initials': 'AB', 'LastName': 'Chakravarthy', 'Affiliation': 'Vanderbilt University Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dorth', 'Affiliation': 'Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio. Electronic address: jennifer.dorth@uhhospitals.org.'}]",Practical radiation oncology,['10.1016/j.prro.2022.01.015']
2350,35717049,"Prone Breast and Lymph Node Irradiation in 5 or 15 Fractions: A Randomized 2 × 2 Design Comparing Dosimetry, Acute Toxicity, and Set-Up Errors.","PURPOSE


Prone whole breast irradiation results in lower dose to organs at risk compared with supine position, especially lung dose. However, the adoption of prone position for whole breast irradiation + lymph node irradiation remains limited and data on lymph node irradiation in 5 fractions are lacking. Although the study was ended prematurely for the primary endpoint (breast retraction at 2 years), we decided to report acute toxicity for prone and supine positions and 5 and 15 fractions. Additionally, dosimetry and set-up accuracy between prone and supine positions were evaluated.
METHODS AND MATERIALS


A randomized open-label factorial 2 × 2 design was used for an acute toxicity comparison between prone and supine positions and 5 and 15 fractions. The primary endpoint of the trial was breast retraction 2 years after treatment. In total, 57 patients were evaluated. Dosimetry and set-up errors were compared between prone and supine positions. All patients were positioned on either our in -house developed prone crawl breast couch or a Posirest-2 (Civco).
RESULTS


No difference in acute toxicity between prone and supine positions was found, but 5 fractions did result in a lower risk of desquamation (15% vs 41%; P = .04). Prone positioning resulted in lower mean ipsilateral lung dose (2.89 vs 4.89 Gy; P < .001), mean thyroid dose (3.42 vs 6.61 Gy; P = .004), and mean contralateral breast dose (0.41 vs 0.54 Gy; P = .007). No significant difference in mean heart dose (0.90 vs 1.07 Gy; P = .22) was found. Set-up accuracy was similar between both positions.
CONCLUSIONS


Unfortunately, the primary endpoint of the trial was not met due to premature closure of the trial. Acceleration in 5 fractions resulted in a lower risk of desquamation. Prone positioning did not influence acute toxicity or set-up accuracy, but did result in lower ipsilateral mean lung dose, thyroid dose, and contralateral breast dose.",2022,"Prone positioning resulted in lower mean ipsilateral lung dose (2.89 vs 4.89 Gy; P < .001), mean thyroid dose (3.42 vs 6.61 Gy; P = .004), and mean contralateral breast dose (0.41 vs 0.54 Gy; P = .007).","['Prone Breast and Lymph Node Irradiation in 5 or 15 Fractions', '57 patients were evaluated', 'All patients were positioned on either our in -house developed prone crawl breast couch or a Posirest-2 (Civco']",[],"['mean heart dose', 'lower risk of desquamation', 'acute toxicity']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0235042', 'cui_str': 'Does crawl'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",57.0,0.0219762,"Prone positioning resulted in lower mean ipsilateral lung dose (2.89 vs 4.89 Gy; P < .001), mean thyroid dose (3.42 vs 6.61 Gy; P = .004), and mean contralateral breast dose (0.41 vs 0.54 Gy; P = .007).","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vakaet', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium; Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium. Electronic address: vincent.vakaet@ugent.be.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Deseyne', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium; Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Schoepen', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium; Department of Industrial Systems Engineering and Product Design, Kortrijk, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stouthandel', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Post', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Speleers', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Van Greveling', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Monten', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Mareel', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Hulle', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Paelinck', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'De Gersem', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Vandecasteele', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium; Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Veldeman', 'Affiliation': 'Department of Human Structure and Repair, Ghent University Hospital, Ghent, Belgium; Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.'}]",Practical radiation oncology,['10.1016/j.prro.2022.01.017']
2351,35717048,Risk-Stratified Intraoperative Radiation Therapy as a Definitive Adjuvant Radiation Therapy Modality for Women With Early Breast Cancer.,"Radiation therapy is an integral component of adjuvant therapy in women who undergo breast conservative surgery, decreasing the likelihood of tumor recurrence and extending survival. The likelihood of tumor recurrence is highest within a proximity of the lumpectomy cavity, which prompted the idea of partial breast irradiation in place of the usual standard-of-care treatment with external beam whole breast radiation therapy. Targeted intraoperative radiation therapy (TARGIT-A) is a multicenter trial initially developed in 1999 and designed as a randomized clinical trial comparing whole breast radiation therapy to risk-adapted intraoperative radiation therapy (IORT). TARGIT-A recruited its first patient in March 2000, with the study concluding in 2012. At a median follow-up of 8.6 years, the prepathology TARGIT-A trial noted results to be noninferior to external beam radiation therapy, with no statistically significant difference in ipsilateral breast tumor recurrence, mastectomy-free survival, distant disease-free survival, or breast cancer-specific mortality. These results are consistent with the majority of retrospective and prospective trials. Risk-adapted IORT, as performed in the prospective randomized TARGIT-A trial, gives level 1 evidence that this approach is a standard option in the treatment of breast cancer.",2022,Targeted intraoperative radiation therapy (TARGIT-A) is a multicenter trial initially developed in 1999 and designed as a randomized clinical trial comparing whole breast radiation therapy to risk-adapted intraoperative radiation therapy (IORT).,"['women who undergo breast conservative surgery', 'Women With Early Breast Cancer', 'TARGIT-A recruited its first patient in March 2000, with the study concluding in 2012']","['whole breast radiation therapy to risk-adapted intraoperative radiation therapy (IORT', 'Radiation therapy', 'intraoperative radiation therapy (TARGIT-A']","['likelihood of tumor recurrence and extending survival', 'ipsilateral breast tumor recurrence, mastectomy-free survival, distant disease-free survival, or breast cancer-specific mortality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0974492,Targeted intraoperative radiation therapy (TARGIT-A) is a multicenter trial initially developed in 1999 and designed as a randomized clinical trial comparing whole breast radiation therapy to risk-adapted intraoperative radiation therapy (IORT).,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': 'Department of Radiation Oncology, Stritch School of Medicine, Loyola University Chicago, Cardinal Bernardin Cancer Center, Maywood, Illinois. Electronic address: wmsmall@lumc.edu.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Refaat', 'Affiliation': 'Department of Radiation Oncology, Stritch School of Medicine, Loyola University Chicago, Cardinal Bernardin Cancer Center, Maywood, Illinois.'}, {'ForeName': 'Sheldon M', 'Initials': 'SM', 'LastName': 'Feldman', 'Affiliation': 'Department of Surgery, Montefiore Einstein Center for Cancer Care, Bronx, New York.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Holmes', 'Affiliation': 'Department of Surgery, Adventist Health Glendale, Glendale, California.'}]",Practical radiation oncology,['10.1016/j.prro.2022.03.015']
2352,35717008,Effect of Remote Ischemic Preconditioning on the Incidence of Contrast Induced Nephropathy in Patients Undergoing Evar (Ripc-Evar Study).,"INTRODUCTION


Contrast induced nephropathy (CIN) is a major inconvenience in the use of iodinated contrast media (ICM) and it is associated with a significant increase in morbidity and mortality and cost of hospitalization. Remote ischemic preconditioning (RIPC) is a non-invasive and cost-effective tissue protection technique that has showed beneficial in decreasing renal insult in patients receiving intravascular contrast.
AIM


The primary outcome of this study is to evaluate the impact of RIPC on the incidence of CIN in patients undergoing endovascular aneurysm repair.
MATERIAL AND METHODS


Patients suffering from aortic aneurysm were recruited prior to the administration of iodinated contrast media. Randomization was used to assign patients into the control/RIPC groups. Biochemical parameters determined renal function before and after surgery in immediate (24-72 hours) and at 30 days' follow-up.
RESULTS


Of the 120 patients included in the study, 98,3% were male. Mean age was 73 years (range 56-87). Diabetes and chronic renal failure (considering eGFR<60) was present prior to administration of ICM in 29,16% and 38,33% respectively. RIPC was applied in 50% (n=60) of the patients. A total of 24,17% developed CIN regardless of fluid therapy, RIPC and other protective strategies. RIPC did not influence outcome in terms of incidence on CIN, serum creatinine, urea, estimated glomerular filtration (eGFR) or microalbuminuria in immediate postoperative period. However, the group of RIPC patients showed a statistically significant benefit in renal function in terms of serum creatinine (1,46 ± 0,3 vs 1,03 ± 0,5; p<0,001), urea (61,06 ± 27,5mg/dl vs 43,78 ± 12,9mg/dl; p=0,003) and an increase in eGFR (56,37 ± 23,4ml/min/1.73m 2 vs 72,85 ± 17,7ml/min/1.73m 2 ; p=0,004) at 30 days follow-up.
CONCLUSIONS


RIPC seems to be a reasonable, effective and low-cost technique to alleviate effects of ICM on the renal parenchyma in EVAR procedures during short-term postoperative period.",2022,"RIPC did not influence outcome in terms of incidence on CIN, serum creatinine, urea, estimated glomerular filtration (eGFR) or microalbuminuria in immediate postoperative period.","['Patients Undergoing Evar', 'patients undergoing endovascular aneurysm repair', '120 patients included in the study', 'Mean age was 73 years (range 56-87', 'Patients suffering from aortic aneurysm were recruited prior to the administration of iodinated contrast media', 'patients receiving intravascular contrast']","['Remote ischemic preconditioning (RIPC', 'Remote Ischemic Preconditioning', 'RIPC']","['renal function', 'Diabetes and chronic renal failure', 'morbidity and mortality and cost of hospitalization', 'CIN, serum creatinine, urea, estimated glomerular filtration (eGFR) or microalbuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0003486', 'cui_str': 'Aortic aneurysm'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1960405', 'cui_str': 'Iodinated contrast media'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}]",120.0,0.0152026,"RIPC did not influence outcome in terms of incidence on CIN, serum creatinine, urea, estimated glomerular filtration (eGFR) or microalbuminuria in immediate postoperative period.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Gutiérrez Castillo', 'Affiliation': ''}, {'ForeName': 'Enrique María', 'Initials': 'EM', 'LastName': 'San Norberto García', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'García Rivera', 'Affiliation': ''}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Fidalgo Domingos', 'Affiliation': ''}, {'ForeName': 'Cintia Mariana', 'Initials': 'CM', 'LastName': 'Flota Ruiz', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Vaquero Puerta', 'Affiliation': ''}]",Annals of vascular surgery,['10.1016/j.avsg.2022.05.018']
2353,35716984,Surgical solutions for preoperative skin preparation in total hip arthroplasty: a cost-effectiveness analysis of Betadine® and Chloraprep™.,"OBJECTIVE


The purpose of our study was to compare the cost of surgical site skin preparation using ChloraPrep™ (2% chlorhexidine gluconate [CHG] and 70% isopropyl alcohol [IPA]) with skin cleansing using Betadine® Surgical Scrub and Betadine® 5% solution (povidone-iodine [PVI]) in total hip arthroplasty (THA).
HYPOTHESIS


The hypothesis was that the ChloraPrep™ skin disinfection protocol reduces the cost of perioperative antisepsis.
METHODS


A prospective database was created for all THAs performed at our university hospital between November 1, 2020, and December 31, 2020. Each surgeon was randomly assigned one type of antiseptic prior to the start of the study: one surgeon to the ChloraPrep™ group and one to the Betadine® group. In both groups, the enrollment stopped at the 15 th  patient. The costs related to consumables, waste disposal, and operating room occupancy time of each protocol were then assessed for each patient.
RESULTS


The mean duration of the ChloraPrep™ protocol was 3.5 ± 0.3 minutes compared to 13.5 ± 0.9 minutes for the Betadine® protocol. The overall cost of a surgical site skin preparation involving all three steps was on average euro46.8 ± 4.2 for the ChloraPrep™ group compared to euro155 ± 10.9 for the Betadine® group (p <0.0001).
DISCUSSION


Not only is the effectiveness of ChloraPrep™ already recognized but it also appears to have health economic benefits. However, further studies are needed to confirm this finding.
LEVEL OF EVIDENCE


III, case control study.",2022,The mean duration of the ChloraPrep™ protocol was 3.5 ± 0.3 minutes compared to 13.5 ± 0.9 minutes for the Betadine® protocol.,"['total hip arthroplasty (THA', 'total hip arthroplasty', 'all THAs performed at our university hospital between November\u20091, 2020, and December\u200931, 2020']","['isopropyl alcohol [IPA]) with skin cleansing using Betadine® Surgical Scrub and Betadine® 5% solution (povidone-iodine [PVI', 'ChloraPrep™ (2% chlorhexidine gluconate [CHG', 'Betadine®', 'Betadine® and Chloraprep™', 'ChloraPrep™ group and one to the Betadine®']","['mean duration', 'costs related to consumables, waste disposal, and operating room occupancy time', 'overall cost of a surgical site skin preparation']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C2936698', 'cui_str': 'Scrubbing, Surgical'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0008586', 'cui_str': 'Chromogranin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034962', 'cui_str': 'Refuse Disposal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}]",,0.0267751,The mean duration of the ChloraPrep™ protocol was 3.5 ± 0.3 minutes compared to 13.5 ± 0.9 minutes for the Betadine® protocol.,"[{'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Rougereau', 'Affiliation': ""Département d'orthopédie, Institut Mutualiste de Montsouris, 42 boulevard Jourdan, 75014, Paris, France; Département d'orthopédie et traumatologie, CHU Pitié-Salpêtrière, AP-HP, Sorbonne Université, Paris, France. Electronic address: greg.rougereau@gmail.com.""}, {'ForeName': 'Léonard', 'Initials': 'L', 'LastName': 'Chatelain', 'Affiliation': ""Département d'orthopédie, Institut Mutualiste de Montsouris, 42 boulevard Jourdan, 75014, Paris, France.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Terracher', 'Affiliation': ""Département d'orthopédie, Institut Mutualiste de Montsouris, 42 boulevard Jourdan, 75014, Paris, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Zadegan', 'Affiliation': ""Département d'orthopédie, Institut Mutualiste de Montsouris, 42 boulevard Jourdan, 75014, Paris, France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Ollat', 'Affiliation': ""Département d'orthopédie, Institut Mutualiste de Montsouris, 42 boulevard Jourdan, 75014, Paris, France.""}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2022.103355']
2354,35717385,Effectiveness of brief counselling in a hospital setting for smoking cessation and risky alcohol drinking reduction: randomised clinical trial protocol.,"INTRODUCTION


Chronic diseases are a public health problem, and 80% of them are related to modifiable risk factors such as unhealthy diet, physical inactivity, smoking, and risky alcohol consumption. Although the intervention in smoking and hazardous alcohol drinking has proven to be effective in Primary Care, it is unknown whether it works in the same way in the hospital setting.
OBJECTIVE


To evaluate the effectiveness of brief counselling in order to modify the stage of change in smokers and at-risk drinkers treated in a high complexity hospital.
METHODS


A Randomised controlled trial to be conducted, in which an evaluation is made of four brief counselling strategies for smoking cessation and risky alcohol consumption compared to usual care, selected according to the patient's stage of change. The primary result will be the proportion of patients in each of the groups (intervention and control) with identified progress in the stage of change. The reduction of consumption will be also be analysed. Protocol registered at ClinicalTrials.gov (NCT03521622).
RESULTS


The results will be published in scientific journals, and its application aims to generate behavioural intervention protocols for modifiable risk factors in high complexity hospitals. The trial was presented and approved by the Ethics and Research Committee of the Pontificia Universidad Javeriana and Hospital Universitario de San Ignacio, Bogota, Colombia (Approval 01/2018).",2022,The primary result will be the proportion of patients in each of the groups (intervention and control) with identified progress in the stage of change.,"['smoking cessation and risky alcohol drinking reduction', 'smokers and at-risk drinkers treated in a high complexity hospital']",['brief counselling'],['smoking cessation and risky alcohol consumption'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.0349623,The primary result will be the proportion of patients in each of the groups (intervention and control) with identified progress in the stage of change.,"[{'ForeName': 'Almonacid', 'Initials': 'A', 'LastName': 'Ingrid', 'Affiliation': 'Departamento de Medicina Preventiva y Social, Hospital Universitario de San Ignacio, Bogotá, Colombia.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Olaya', 'Affiliation': 'Departamento de Medicina Preventiva y Social, Hospital Universitario de San Ignacio, Bogotá, Colombia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Cuevas', 'Affiliation': 'Departamento de Medicina Preventiva y Social, Hospital Universitario de San Ignacio, Bogotá, Colombia.'}, {'ForeName': 'Juan Sebastián', 'Initials': 'JS', 'LastName': 'Castillo', 'Affiliation': 'Departamento de Medicina Preventiva y Social, Hospital Universitario de San Ignacio, Bogotá, Colombia.'}, {'ForeName': 'Nelci', 'Initials': 'N', 'LastName': 'Becerra', 'Affiliation': 'Departamento de Medicina Preventiva y Social, Hospital Universitario de San Ignacio, Bogotá, Colombia.'}, {'ForeName': 'Jimena', 'Initials': 'J', 'LastName': 'Delgado', 'Affiliation': 'Programa de Promoción y Prevención, Hospital Universitario de San Ignacio, Bogotá, Colombia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Cañas', 'Affiliation': 'Departamento de Medicina Interna, Hospital Universitario de San Ignacio-Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Luz Helena', 'Initials': 'LH', 'LastName': 'Alba', 'Affiliation': 'Departamento de Medicina Preventiva y Social, Hospital Universitario de San Ignacio, Bogotá, Colombia. Electronic address: lalba@javeriana.edu.co.'}]",Revista Colombiana de psiquiatria (English ed.),['10.1016/j.rcpeng.2020.06.003']
2355,35717357,Clinical Efficacy of Venastent - A Novel Iliac Vein Stent for Non-Thrombotic Iliac Vein Lesions: A Multi-Centre Randomised Controlled Trial.,"OBJECTIVE


To determine the efficacy of Venastent - a novel iliac vein stent for non-thrombotic iliac vein lesions (NIVLs).
METHODS


From October 2018 to January 2021, 256 NIVL patients were recruited at 19 Chinese hospitals. A randomised controlled trial was conducted to compare the efficacy of the new iliac vein stent-Venastent (Tianhong China) with Zilver stent (Cook USA). All patients were allocated randomly to two groups: the experimental group patients used Venastent, while the control group received the Zilver stent. The trial was registered in Chinese Clinical Trial Registry (ChiCTR2200057851).
RESULTS


A total of 123 patients in the experimental group and 122 patients in the control group had a full set of data collected (p = ns). The technical success rate was 100% (n = 245/245). The patency rate was 100% (n = 123/123) in the experimental group and 98.4% (n = 120/122) in control group one year after operation (p = ns). The lower extremity swelling remission rate was 79.1% (n = 87/110) in the experimental group and 78.4% (n = 91/116) in the control group (p = ns). The lower extremity pain relief rate was 68.8% (n = 50/80) in the experimental group and 77.2% (n = 71/92) in the control group (p = ns). The ulcer healing rate was 90% (n = 18/20) in the experimental group and 87% (n = 20/23) in the control group (p = ns). There was no difference in stent re-stenosis or clinical remission between the two groups.
CONCLUSION


The new iliac vein stent, Venastent, had a comparable high patency rate and safety profile as the Zilver stent (Cook) in NIVLs patients. Venastent significantly reduced symptoms of chronic venous disease.",2022,The lower extremity pain relief rate was 68.8% (n = 50/80) in the experimental group and 77.2% (n = 71/92) in the control group (p = ns).,"['256 NIVL patients were recruited at 19 Chinese hospitals', 'From October 2018 to January 2021', '123 patients in the experimental group and 122 patients in the control group had a full set of data collected (p\xa0= ns', 'Non-Thrombotic Iliac Vein Lesions']","['Venastent - A Novel Iliac Vein Stent', 'Venastent - a novel iliac vein stent', 'new iliac vein stent-Venastent (Tianhong China) with Zilver stent (Cook USA', 'Zilver stent']","['patency rate', 'symptoms of chronic venous disease', 'ulcer healing rate', 'lower extremity pain relief rate', 'patency rate and safety profile', 'technical success rate', 'lower extremity swelling remission rate', 'stent re-stenosis or clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0020888', 'cui_str': 'Iliac vein structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0020888', 'cui_str': 'Iliac vein structure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0239376', 'cui_str': 'Pain of lower extremities'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",256.0,0.144611,The lower extremity pain relief rate was 68.8% (n = 50/80) in the experimental group and 77.2% (n = 71/92) in the control group (p = ns).,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital of USTC, Anhui, China.'}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital of USTC, Anhui, China.'}, {'ForeName': 'Zhengdong', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital of USTC, Anhui, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital of USTC, Anhui, China.'}, {'ForeName': 'Xinbao', 'Initials': 'X', 'LastName': 'Ge', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital of USTC, Anhui, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital of USTC, Anhui, China.'}, {'ForeName': 'Haiquan', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Inner Mongolia University of Technology, Hohhot, China.'}, {'ForeName': 'Hejie', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital of USTC, Anhui, China. Electronic address: hu.hejie@163.com.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2022.04.005']
2356,35717354,Impact of dronedarone on patients with atrial fibrillation and diabetes: A sub-analysis of the ATHENA and EURIDIS/ADONIS studies.,"AIM


This post hoc analysis evaluated efficacy and safety of dronedarone in atrial fibrillation (AF) and atrial flutter (AFL) patients with/without diabetes.
METHODS


Patients were categorized according to baseline diabetes status. Time-to-event analyses were performed using Kaplan-Meier method. Hazard-ratios were assessed using Cox models.
RESULTS


945/4628 (dronedarone = 482; placebo = 463) patients in ATHENA and 215/1237 (dronedarone = 148; placebo = 67) patients in EURIDIS/ADONIS studies had diabetes. In ATHENA, there were higher rates of CV hospitalization/death in patients with diabetes (39.5%) than without diabetes (34.7%). Incidence of first CV hospitalization/death was lower in patients with diabetes treated with dronedarone (35.1%) than placebo (44.1%), and time to this event was longer in those treated with dronedarone than placebo (log-rank p = 0.005). Median AF/AFL recurrence time was longer in patients treated with dronedarone than placebo in patients with diabetes (ATHENA: 722 vs 527 days, log-rank p = 0.004; EURIDIS/ADONIS: 100 vs 23 days, log-rank p = 0.15) or without diabetes (ATHENA: 741 vs 492 days, log-rank p < 0.0001; EURIDIS/ADONIS: 120 vs 59 days, log-rank p = 0.0002). Occurrence of any treatment-related adverse events with dronedarone was similar for patients with/without diabetes and was comparable to placebo.
CONCLUSIONS


Dronedarone reduced incidence of CV hospitalization/death, AF/AFL recurrence and increased time to these events in AF/AFL patients with/without diabetes.
TRIAL REGISTRATION


Not applicable, as it was a post hoc analysis. This article is based on previously conducted studies (ATHENA: NCT00174785, EURIDIS: NCT00259428, and ADONIS: NCT00259376).",2022,"Median AF/AFL recurrence time was longer in patients treated with dronedarone than placebo in patients with diabetes (ATHENA: 722 vs 527 days, log-rank","['atrial fibrillation (AF) and atrial flutter (AFL) patients with/without diabetes', 'Patients were categorized according to baseline diabetes status', 'patients with atrial fibrillation and diabetes', '945/4628 (dronedarone\xa0=\xa0482; placebo\xa0=\xa0463) patients in ATHENA and 215/1237 (dronedarone\xa0=\xa0148', '\xa067) patients in EURIDIS/ADONIS studies had diabetes']","['dronedarone', 'Dronedarone', 'placebo']","['Hazard-ratios', 'Incidence of first CV hospitalization/death', 'rates of CV hospitalization/death', 'Median AF/AFL recurrence time', 'incidence of CV hospitalization/death, AF/AFL recurrence']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0330253', 'cui_str': 'Adonis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",463.0,0.0989008,"Median AF/AFL recurrence time was longer in patients treated with dronedarone than placebo in patients with diabetes (ATHENA: 722 vs 527 days, log-rank","[{'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Handelsman', 'Affiliation': 'Metabolic Institute of America, Tarzana, CA, United States of America. Electronic address: yhandelsman@gmail.com.'}, {'ForeName': 'T Jared', 'Initials': 'TJ', 'LastName': 'Bunch', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, UT, United States of America. Electronic address: jared.bunch@hsc.utah.edu.'}, {'ForeName': 'Helena W', 'Initials': 'HW', 'LastName': 'Rodbard', 'Affiliation': 'Endocrine and Metabolic Consultants, Rockville, MD, United States of America. Electronic address: hrodbard@comcast.net.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Steinberg', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, UT, United States of America. Electronic address: Benjamin.steinberg@hsc.utah.edu.'}, {'ForeName': 'Munveer', 'Initials': 'M', 'LastName': 'Thind', 'Affiliation': 'Lankenau Heart Institute, Lankenau Medical Center, Wynnewood, PA, United States of America. Electronic address: thindm@me.com.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Bigot', 'Affiliation': 'IVIDATA, Paris, France. Electronic address: Gregory.Bigot-ext@sanofi.com.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Konigsberg', 'Affiliation': 'Sanofi, Bridgewater, NJ, United States of America. Electronic address: Lana.Konigsberg@sanofi.com.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Wieloch', 'Affiliation': 'Sanofi, Paris, France; Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden. Electronic address: Mattias.Wieloch@sanofi.com.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Kowey', 'Affiliation': 'Lankenau Heart Institute, Lankenau Medical Center, Wynnewood, PA, United States of America. Electronic address: KoweyP@mlhs.org.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2022.108227']
2357,35717342,A randomized placebo-controlled clinical trial for pharmacological activation of BCAA catabolism in patients with type 2 diabetes.,"Elevations in plasma branched-chain amino acid (BCAA) levels associate with insulin resistance and type 2 diabetes (T2D). Pre-clinical models suggest that lowering BCAA levels improve glucose tolerance, but data in humans are lacking. Here, we used sodium phenylbutyrate (NaPB), an accelerator of BCAA catabolism, as tool to lower plasma BCAA levels in patients with T2D, and evaluate its effect on metabolic health. This trial (NetherlandsTrialRegister: NTR7426) had a randomized, placebo-controlled, double-blind cross-over design and was performed in the Maastricht University Medical Center (MUMC+), the Netherlands, between February 2019 and February 2020. Patients were eligible for the trial if they were 40-75years, BMI of 25-38 kg/m², relatively well-controlled T2D (HbA1C < 8.5%) and treated with oral glucose-lowering medication. Eighteen participants were randomly assigned to receive either NaPB 4.8 g/m²/day and placebo for 2 weeks via controlled randomization and sixteen participants completed the study. The primary outcome was peripheral insulin sensitivity. Secondary outcomes were ex vivo muscle mitochondrial oxidative capacity, substrate oxidation and ectopic fat accumulation. Fasting blood samples were collected to determine levels of BCAA, their catabolic intermediates, insulin, triglycerides, free fatty acids (FFA) and glucose. NaPB led to a robust 27% improvement in peripheral insulin sensitivity compared to placebo (ΔRd:13.2 ± 1.8 vs. 9.6 ± 1.8 µmol/kg/min, p = 0.02). This was paralleled by an improvement in pyruvate-driven muscle mitochondrial oxidative capacity and whole-body insulin-stimulated carbohydrate oxidation, and a reduction in plasma BCAA and glucose levels. No effects were observed on levels of insulin, triglycerides and FFA, neither did fat accumulation in muscle and liver change. No adverse events were reported. These data establish the proof-of-concept in humans that modulating the BCAA oxidative pathway may represent a potential treatment strategy for patients with T2D.",2022,"No effects were observed on levels of insulin, triglycerides and FFA, neither did fat accumulation in muscle and liver change.","['patients with type 2 diabetes', 'Eighteen participants', 'Maastricht University Medical Center (MUMC+), the Netherlands, between February 2019 and February 2020', 'patients with T2D', 'Patients were eligible for the trial if they were 40-75years, BMI of 25-38\u2009kg/m², relatively well-controlled T2D (HbA1C\u2009<\u20098.5%) and treated with oral glucose-lowering medication']","['NaPB 4.8\u2009g/m²/day and placebo', 'NaPB', 'placebo', 'sodium phenylbutyrate (NaPB']","['adverse events', 'Fasting blood samples', 'ex vivo muscle mitochondrial oxidative capacity, substrate oxidation and ectopic fat accumulation', 'plasma BCAA and glucose levels', 'levels of BCAA, their catabolic intermediates, insulin, triglycerides, free fatty acids (FFA) and glucose', 'plasma BCAA levels', 'levels of insulin, triglycerides and FFA, neither did\xa0fat accumulation\xa0in muscle and liver change', 'peripheral insulin sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1834304', 'cui_str': 'Hereditary Neuralgic Amyotrophy'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0718066', 'cui_str': 'sodium phenylbutyrate'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",18.0,0.512888,"No effects were observed on levels of insulin, triglycerides and FFA, neither did fat accumulation in muscle and liver change.","[{'ForeName': 'Froukje', 'Initials': 'F', 'LastName': 'Vanweert', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, 6229 ER, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Neinast', 'Affiliation': 'Cardiovascular Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, PA, 19104, USA.'}, {'ForeName': 'Edmundo Erazo', 'Initials': 'EE', 'LastName': 'Tapia', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, 6229 ER, The Netherlands.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'van de Weijer', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, 6229 ER, The Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, 6229 ER, The Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, 6229 ER, The Netherlands.'}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Blair', 'Affiliation': 'Cardiovascular Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, PA, 19104, USA.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Bornstein', 'Affiliation': 'Cardiovascular Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, PA, 19104, USA.'}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, 6229 ER, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, 6229 ER, The Netherlands.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Arany', 'Affiliation': 'Cardiovascular Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, PA, 19104, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, 6229 ER, The Netherlands. esther.phielix@maastrichtuniversity.nl.'}]",Nature communications,['10.1038/s41467-022-31249-9']
2358,35717303,A mobile-based pregaming drinking prevention intervention for college students: study protocol for a randomized controlled trial.,"BACKGROUND


Pregaming is a high-drink context popular among college students that often leads to elevated blood alcohol levels and negative consequences. Over 15 years of research studies have demonstrated that pregaming represents one of the riskiest known behaviors among college students, yet no pregaming-specific interventions have been developed to help prevent this behavior. General brief interventions for students do not reduce pregaming behavior and may not be appropriate, as they do not help students develop skills unique to the pregaming context that could help them drink less. We developed a brief, mobile-based intervention that is proposed to prevent heavy drinking during pregaming for college students, with the ultimate goal that behavioral reductions in this risky practice will ultimately affect global drinking and prevent consequences.
METHODS/DESIGN


The intervention, Pregaming Awareness in College Environments (PACE), was developed by combining two innovations to facilitate behavior change: (1) a mobile-based application that increases accessibility, is easy and engaging to use, and broadens the reach of the intervention content and (2) personalized pregaming-specific intervention content with harm reduction and cognitive behavioral skills proven to be mechanisms preventing and reducing heavy drinking among college students. After a develop and beta-test phase, we propose to test the efficacy of PACE in a preliminary randomized controlled trial with 500 college students who pregame at least once per week. Pregaming, general drinking, and alcohol-related consequences outcomes will be examined in the immediate (2 weeks post-intervention) and short-terms (six and 14-week post-intervention). We will also evaluate moderator effects for age, sex, and heaviness of drinking to allow for more refined information for a planned larger test of the intervention to follow this initial trial of PACE.
DISCUSSION


This pregaming intervention clinical trial, if found to be efficacious, will culminate with an easily-disseminated mobile-based intervention for college student drinkers. It has the potential to reach millions of college students, perhaps as a clinical tool used by college counseling centers as an adjunct to formal care or as a preventive tool for first-year students or other high-risk groups on campus.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT04016766.",2022,"We developed a brief, mobile-based intervention that is proposed to prevent heavy drinking during pregaming for college students, with the ultimate goal that behavioral reductions in this risky practice will ultimately affect global drinking and prevent consequences.
","['500 college students who pregame at least once per week', 'college student drinkers', 'college students']",['mobile-based pregaming drinking prevention intervention'],[],"[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],500.0,0.0361402,"We developed a brief, mobile-based intervention that is proposed to prevent heavy drinking during pregaming for college students, with the ultimate goal that behavioral reductions in this risky practice will ultimately affect global drinking and prevent consequences.
","[{'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Pedersen', 'Affiliation': 'Keck School of Medicine, Department of Psychiatry and Behavioral Sciences, USC Institute for Addiction Science, University of Southern California, 2250 Alcazar Street, Suite 2200, Los Angeles, CA, 90033, United States. Eric.Pedersen@med.usc.edu.'}, {'ForeName': 'Justin F', 'Initials': 'JF', 'LastName': 'Hummer', 'Affiliation': 'RAND Corporation, Santa Monica, United States.'}, {'ForeName': 'Jordan P', 'Initials': 'JP', 'LastName': 'Davis', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work; USC Center for Artificial Intelligence in Society; USC Center for Mindfulness Science; USC Institute for Addiction Science, University of Southern California, Los Angeles, United States.'}, {'ForeName': 'Reagan E', 'Initials': 'RE', 'LastName': 'Fitzke', 'Affiliation': 'Keck School of Medicine, Department of Psychiatry and Behavioral Sciences, USC Institute for Addiction Science, University of Southern California, 2250 Alcazar Street, Suite 2200, Los Angeles, CA, 90033, United States.'}, {'ForeName': 'Nina C', 'Initials': 'NC', 'LastName': 'Christie', 'Affiliation': 'Department of Psychology, University of Southern California, Los Angeles, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, United States.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clapp', 'Affiliation': 'Suzanne Dworkak-Peck School of Social Work; Department of Population and Public Health Sciences, Keck School of Medicine; USC Institute for Addiction Science, University of Southern California, Los Angeles, United States.'}]",Addiction science & clinical practice,['10.1186/s13722-022-00314-5']
2359,35717284,Screening and addressing social needs of children and families enrolled in a pediatric weight management program: a protocol for a pilot randomized controlled trial.,"BACKGROUND


There is a paucity of evidence to support interventions that address the social needs of children and families with chronic medical conditions. The primary objective of this pilot randomized controlled trial (RCT) is to assess the feasibility of an intervention that screens for and addresses the social needs of children and families enrolled in a pediatric weight management clinic.
METHOD


We will conduct a single-center, pilot RCT of 40 families with children enrolled in a pediatric weight management program at a tertiary children's hospital in Ontario, Canada. Families who are experiencing unmet social needs will be randomized to either a community navigator or self-navigation of community resources. The primary feasibility outcomes and criteria for success include the following: (1) recruitment rates, will be successful if 80% of our target sample is met in the 6 months of recruitment; (2) uptake of intervention, will be considered successful if > 80% of families complete the intervention; and (3) follow-up of participants, will be considered successful if > 90% of participants complete all the study visits. The secondary outcomes include estimating the preliminary effects on body mass index, body composition, and quality of life at 6 months. The analysis of feasibility outcomes will be based on descriptive statistics, and analysis of secondary clinical outcomes will be reported as estimates of effect. We will not perform tests of significance since these analyses are purely exploratory.
DISCUSSION


This study is important because it will aim to improve the treatment of pediatric obesity by testing the feasibility of an intervention that addresses unmet social needs.
TRIAL REGISTRATION


ClinicalTrias.gov : NCT04711707 (Registered January 13, 2021).",2022,Families who are experiencing unmet social needs will be randomized to either a community navigator or self-navigation of community resources.,"[""40 families with children enrolled in a pediatric weight management program at a tertiary children's hospital in Ontario, Canada"", 'children and families with chronic medical conditions', 'Families who are experiencing unmet social needs', 'children and families enrolled in a pediatric weight management clinic', 'children and families enrolled in a pediatric weight management program']",['community navigator or self-navigation of community resources'],"['body mass index, body composition, and quality of life at 6 months', 'criteria for success include the following: (1) recruitment rates']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]",40.0,0.160794,Families who are experiencing unmet social needs will be randomized to either a community navigator or self-navigation of community resources.,"[{'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Wahi', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada. wahig@mcmaster.ca.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Marjerrison', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Carline', 'Initials': 'C', 'LastName': 'Gutierrez', 'Affiliation': ""Children's Exercise and Nutrition Centre, McMaster Children's Hospital, Hamilton, Canada.""}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Krasevich', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Morrison', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}]",Pilot and feasibility studies,['10.1186/s40814-022-01080-6']
2360,35717263,Can the prophylactic administration of tranexamic acid reduce the blood loss after robotic-assisted radical prostatectomy? Robotic Assisted Radical Prostatectomy with tranEXamic acid (RARPEX): study protocol for a randomized controlled trial.,"BACKGROUND


The prophylactic administration of tranexamic acid reduces blood loss during procedures at high risk of perioperative bleeding. Several studies in cardiac surgery and orthopedics confirmed this finding. The aim of this prospective, double-blind, randomized study is to evaluate the effect of tranexamic acid on peri-and postoperative blood loss and on the incidence and severity of complications.
METHODS/DESIGN


Based on the results of our pilot study, we decided to conduct this prospective, double-blind, randomized trial to confirm the preliminary data. The primary endpoint is to analyze the effect of tranexamic acid on perioperative and postoperative blood loss (decrease in hemoglobin levels) in robotic-assisted radical prostatectomy. The additional endpoint is to analyze the effect of tranexamic acid on postoperative complications and confirm the safety of tranexamic acid in robotic-assisted radical prostatectomy.
DISCUSSION


No study to date has tested the prophylactic administration of tranexamic acid at the beginning of robotic-assisted radical prostatectomy. This study is designed to answer the question of whether the administration of tranexamic acid might lower the blood loss after the procedure or increase the rate and severity of complications.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04319614. Registered on 25 March 2020.",2022,No study to date has tested the prophylactic administration of tranexamic acid at the beginning of robotic-assisted radical prostatectomy.,[],"['robotic-assisted radical prostatectomy', 'tranexamic acid', 'Robotic Assisted Radical Prostatectomy with tranEXamic acid (RARPEX']","['blood loss', 'peri-and postoperative blood loss', 'perioperative and postoperative blood loss', 'rate and severity of complications', 'hemoglobin levels']",[],"[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",,0.461939,No study to date has tested the prophylactic administration of tranexamic acid at the beginning of robotic-assisted radical prostatectomy.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balik', 'Affiliation': 'Department of Urology, Charles University, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 03, Hradec Kralove, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kosina', 'Affiliation': 'Department of Urology, Charles University, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 03, Hradec Kralove, Czech Republic.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Husek', 'Affiliation': 'Department of Urology, Charles University, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 03, Hradec Kralove, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pacovsky', 'Affiliation': 'Department of Urology, Charles University, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 03, Hradec Kralove, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brodak', 'Affiliation': 'Department of Urology, Charles University, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 03, Hradec Kralove, Czech Republic.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cecka', 'Affiliation': 'Department of Surgery, Charles University, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 03, Hradec Kralove, Czech Republic. filip.cecka@seznam.cz.'}]",Trials,['10.1186/s13063-022-06447-x']
2361,35717262,Using text and charts to provide social norm feedback to general practices with high overall and high broad-spectrum antibiotic prescribing: a series of national randomised controlled trials.,"BACKGROUND


Sending a social norms feedback letter to general practitioners who are high prescribers of antibiotics has been shown to reduce antibiotic prescribing. The 2017-9 Quality Premium for primary care in England sets a target for broad-spectrum prescribing, which should be at or below 10% of total antibiotic prescribing. We tested a social norm feedback letter that targeted broad-spectrum prescribing and the addition of a chart to a text-only letter that targeted overall prescribing.
METHODS


We conducted three 2-armed randomised controlled trials, on different groups of practices: Trial A compared a broad-spectrum message and chart to the standard-practice overall prescribing letter (practices whose percentage of broad-spectrum prescribing was above 10% and who had relatively high overall prescribing). Trial C compared a broad-spectrum message and a chart to a no-letter control (practices whose percentage of broad-spectrum prescribing was above 10% and who had relatively moderate overall prescribing). Trial B compared an overall-prescribing message with a chart to the standard practice overall letter (practices whose percentage of broad-spectrum prescribing was below 10% but who had relatively high overall prescribing). Letters were posted to general practitioners, timed to be received on 1 November 2018. The primary outcomes were practices' percentage of broad-spectrum prescribing (trials A and C) and overall antibiotic prescribing (trial B) each month from November 2018 to April 2019 (all weighted by the number and characteristics of patients registered in the practice).
RESULTS


We randomly assigned 1909 practices; 58 closed or merged during the trial, leaving 1851 practices: 385 in trial A, 674 in trial C, and 792 in trial B. AR(1) models showed that there were no statistically significant differences in our primary outcome measures: trial A β = - .199, p = .13; trial C β = .006, p = .95; trial B β = - .0021, p = .81. In all three trials, there were statistically significant time trends, showing that overall antibiotic prescribing and total broad-spectrum prescribing were decreasing.
CONCLUSION


Our broad-spectrum feedback letters had no effect on broad-spectrum prescribing; adding a bar chart to a text-only letter had no effect on overall antibiotic prescribing. Broad-spectrum and overall prescribing were both decreasing over time.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03862794. March 5, 2019.",2022,"In all three trials, there were statistically significant time trends, showing that overall antibiotic prescribing and total broad-spectrum prescribing were decreasing.
",[],[],"['overall antibiotic prescribing and total broad-spectrum prescribing', 'overall antibiotic prescribing', ""practices' percentage of broad-spectrum prescribing (trials A and C) and overall antibiotic prescribing""]",[],[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",,0.155556,"In all three trials, there were statistically significant time trends, showing that overall antibiotic prescribing and total broad-spectrum prescribing were decreasing.
","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gold', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK. n.gold@lse.ac.uk.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sallis', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Saei', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Arambepola', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Watson', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Matija', 'Initials': 'M', 'LastName': 'Franklin', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}]",Trials,['10.1186/s13063-022-06373-y']
2362,35717243,Promoting interactive skills and mind-mindedness among early childcare professionals: study protocol for a randomized wait-list controlled trial comparing the Circle of Security approach with care as usual in center-based childcare (the SECURE project).,"BACKGROUND


In countries where the majority of young children are enrolled in professional childcare, the childcare setting constitutes an important part of children's caregiving environment. Research consistently shows that particularly the quality of the daily interactions and relationship between young children and their professional caregivers have long-term effects on a range of developmental child outcomes. Therefore, professional caregivers' capacity for establishing high quality interactions with the children in their care is an important target of intervention.
METHODS


A prospective, parallel, cluster-randomized wait-list controlled trial is used to test the efficacy of the attachment- and mentalization theory informed Circle of Security (COS) approach adapted to the childcare setting (COS-Classroom) on caregiver interactive skills and mind-mindedness. Participants are professional caregivers of children aged 0-2.9 years working in center-based childcare in Denmark. Approximately 31 childcare centers, corresponding to an estimated 113 caregivers, are expected to participate. The primary outcome is caregiver Sensitive responsiveness measured with the Caregiver Interactive Profile Scales (CIP-scales). Secondary outcomes include caregiver Mind-mindedness, the five remaining CIP-scales (Respect for autonomy, Structure and limit setting, Verbal communication, Developmental stimulation, and Fostering positive peer interactions), and caregivers' resources to cope with work-related stress. Data on structural factors (e.g., staff stability, caregiver-child ratio, and level of pre-service education), caregiver attachment style, acceptability and feasibility of the COS-C together with qualitative data on how the participants experience the COS-C is additionally collected to investigate moderating and confounding effects.
DISCUSSION


Examining the effectiveness of the COS-C in center-based childcare contributes to the knowledge of evidence-based intervention programs and can potentially improve the caregiver quality early childcare.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04654533. Prospectively registered December 4, 2020, https://clinicaltrials.gov/ct2/show/NCT04654533 .",2022,"Examining the effectiveness of the COS-C in center-based childcare contributes to the knowledge of evidence-based intervention programs and can potentially improve the caregiver quality early childcare.
","['Participants are professional caregivers of children aged 0-2.9\xa0years working in center-based childcare in Denmark', 'Approximately 31 childcare centers, corresponding to an estimated 113 caregivers', 'early childcare professionals']","['COS-C', 'attachment- and mentalization theory informed Circle of Security (COS) approach']","[""caregiver Mind-mindedness, the five remaining CIP-scales (Respect for autonomy, Structure and limit setting, Verbal communication, Developmental stimulation, and Fostering positive peer interactions), and caregivers' resources to cope with work-related stress"", 'caregiver Sensitive responsiveness measured with the Caregiver Interactive Profile Scales (CIP-scales', 'structural factors (e.g., staff stability, caregiver-child ratio, and level of pre-service education), caregiver attachment style, acceptability and feasibility of the COS-C']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0454802', 'cui_str': 'Cos'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1855739', 'cui_str': 'Indifference to Pain, Congenital, Autosomal Recessive'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0150269', 'cui_str': 'Limit setting'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0454802', 'cui_str': 'Cos'}]",,0.216085,"Examining the effectiveness of the COS-C in center-based childcare contributes to the knowledge of evidence-based intervention programs and can potentially improve the caregiver quality early childcare.
","[{'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Smith-Nielsen', 'Affiliation': 'Department of Psychology, University of Copenhagen, Øster Farimagsgade 2A, 1353, Copenhagen, Denmark. johanne.smith-nielsen@psy.ku.dk.'}, {'ForeName': 'Katrine Isabella', 'Initials': 'KI', 'LastName': 'Wendelboe', 'Affiliation': 'Department of Psychology, University of Copenhagen, Øster Farimagsgade 2A, 1353, Copenhagen, Denmark.'}, {'ForeName': 'Julie Elisabeth Warberg', 'Initials': 'JEW', 'LastName': 'Mohr', 'Affiliation': 'Department of Psychology, University of Copenhagen, Øster Farimagsgade 2A, 1353, Copenhagen, Denmark.'}, {'ForeName': 'Mette Skovgaard', 'Initials': 'MS', 'LastName': 'Væver', 'Affiliation': 'Department of Psychology, University of Copenhagen, Øster Farimagsgade 2A, 1353, Copenhagen, Denmark.'}, {'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Pontoppidan', 'Affiliation': 'Department of Health, VIVE-The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1353, Copenhagen, Denmark.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Helmerhorst', 'Affiliation': 'Department of Pedagogy and Educational Sciences, Child and Family Welfare, University of Groningen, Grote Rozenstraat 38, 9712 TJ, Groningen, The Netherlands.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Egmose', 'Affiliation': 'Department of Psychology, University of Copenhagen, Øster Farimagsgade 2A, 1353, Copenhagen, Denmark.'}]",BMC psychology,['10.1186/s40359-022-00835-3']
2363,35717241,"Effect of intravenous clarithromycin in patients with sepsis, respiratory and multiple organ dysfunction syndrome: a randomized clinical trial.","BACKGROUND


Clarithromycin may act as immune-regulating treatment in sepsis and acute respiratory dysfunction syndrome. However, clinical evidence remains inconclusive. We aimed to evaluate whether clarithromycin improves 28-day mortality among patients with sepsis, respiratory and multiple organ dysfunction syndrome.
METHODS


We conducted a multicenter, randomized, clinical trial in patients with sepsis. Participants with ratio of partial oxygen pressure to fraction of inspired oxygen less than 200 and more than 3 SOFA points from systems other than the respiratory function were enrolled between December 2017 and September 2019. Patients were randomized to receive 1 gr of clarithromycin or placebo intravenously once daily for 4 consecutive days. The primary endpoint was 28-day all-cause mortality. Secondary outcomes were 90-day mortality; sepsis response (defined as at least 25% decrease in SOFA score by day 7); sepsis recurrence; and differences in peripheral blood cell populations and leukocyte transcriptomics.
RESULTS


Fifty-five patients were allocated to each arm. By day 28, 27 (49.1%) patients in the clarithromycin and 25 (45.5%) in the placebo group died (risk difference 3.6% [95% confidence interval (CI) - 15.7 to 22.7]; P = 0.703, adjusted OR 1.03 [95%CI 0.35-3.06]; P = 0.959). There were no statistical differences in 90-day mortality and sepsis response. Clarithromycin was associated with lower incidence of sepsis recurrence (OR 0.21 [95%CI 0.06-0.68]; P = 0.012); significant increase in monocyte HLA-DR expression; expansion of non-classical monocytes; and upregulation of genes involved in cholesterol homeostasis. Serious and non-serious adverse events were equally distributed.
CONCLUSIONS


Clarithromycin did not reduce mortality among patients with sepsis with respiratory and multiple organ dysfunction. Clarithromycin was associated with lower sepsis recurrence, possibly through a mechanism of immune restoration. Clinical trial registration clinicaltrials.gov identifier NCT03345992 registered 17 November 2017; EudraCT 2017-001056-55.",2022,Clarithromycin was associated with lower incidence of sepsis recurrence (OR 0.21,"['patients with sepsis', 'Fifty-five patients', 'patients with sepsis with respiratory and multiple organ dysfunction', 'patients with sepsis, respiratory and multiple organ dysfunction syndrome', '17 November 2017; EudraCT 2017-001056-55', 'Participants with ratio of partial oxygen pressure to fraction of inspired oxygen less than 200 and more than 3 SOFA points from systems other than the respiratory function were enrolled between December 2017 and September 2019']","['clarithromycin', 'Clarithromycin', 'clarithromycin or placebo', 'placebo', 'intravenous clarithromycin']","['28-day mortality', 'peripheral blood cell populations and leukocyte transcriptomics', 'lower sepsis recurrence', '90-day mortality and sepsis response', 'Serious and non-serious adverse events', '90-day mortality; sepsis response', '28-day all-cause mortality', 'sepsis recurrence', 'monocyte HLA-DR expression; expansion of non-classical monocytes; and upregulation of genes involved in cholesterol homeostasis', 'SOFA score by day 7); sepsis recurrence', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005773', 'cui_str': 'Blood cell'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR antigen'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.380516,Clarithromycin was associated with lower incidence of sepsis recurrence (OR 0.21,"[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Karakike', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, 1 Rimini Street, 124 62, Athens, Greece.'}, {'ForeName': 'Brendon P', 'Initials': 'BP', 'LastName': 'Scicluna', 'Affiliation': 'Division of Infectious Diseases, Center for Experimental Molecular Medicine, Amsterdam University Medical Centers, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Roumpoutsou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, 1 Rimini Street, 124 62, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Mitrou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, 1 Rimini Street, 124 62, Athens, Greece.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Karampela', 'Affiliation': 'Intensive Care Unit, Korgialeneio Benakeio General Hospital, Athens, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Karageorgos', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, 1 Rimini Street, 124 62, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Psaroulis', 'Affiliation': 'Intensive Care Unit, Aghios Dimitrios General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Massa', 'Affiliation': 'Intensive Care Unit, Hippokration General Hospital, Athens, Greece.'}, {'ForeName': 'Achillefs', 'Initials': 'A', 'LastName': 'Pitsoulis', 'Affiliation': 'Intensive Care Unit, G. Gennimatas General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Chaloulis', 'Affiliation': 'Intensive Care Unit, Theageneion General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Pappa', 'Affiliation': 'Intensive Care Unit, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Irene T', 'Initials': 'IT', 'LastName': 'Schrijver', 'Affiliation': 'Infectious Diseases Service, Department of Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Frantzeska', 'Initials': 'F', 'LastName': 'Frantzeskaki', 'Affiliation': '2nd Department of Critical Care Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Malvina', 'Initials': 'M', 'LastName': 'Lada', 'Affiliation': '2nd Department of Internal Medicine, Sismanogleion General Hospital, Athens, Greece.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dauby', 'Affiliation': 'Department of Infectious Diseases, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'De Bels', 'Affiliation': 'Department of Intensive Care, Centre Hospitalier Universitaire Brugmann, Brussels, Belgium.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Floros', 'Affiliation': 'Intensive Care Unit, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Souzana', 'Initials': 'S', 'LastName': 'Anisoglou', 'Affiliation': 'Intensive Care Unit, Theageneion General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Antoniadou', 'Affiliation': 'Intensive Care Unit, G. Gennimatas General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Patrani', 'Affiliation': 'Intensive Care Unit, Korgialeneio Benakeio General Hospital, Athens, Greece.'}, {'ForeName': 'Glykeria', 'Initials': 'G', 'LastName': 'Vlachogianni', 'Affiliation': 'Intensive Care Unit, Aghios Dimitrios General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mouloudi', 'Affiliation': 'Intensive Care Unit, Hippokration General Hospital, Athens, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Antoniadou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, 1 Rimini Street, 124 62, Athens, Greece.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grimaldi', 'Affiliation': 'Department of Intensive Care, CUB-Erasme, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Roger', 'Affiliation': 'Infectious Diseases Service, Department of Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'W Joost', 'Initials': 'WJ', 'LastName': 'Wiersinga', 'Affiliation': 'Division of Infectious Diseases, Center for Experimental Molecular Medicine, Amsterdam University Medical Centers, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Iraklis', 'Initials': 'I', 'LastName': 'Tsangaris', 'Affiliation': '2nd Department of Critical Care Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, 1 Rimini Street, 124 62, Athens, Greece. egiamarel@med.uoa.gr.'}]","Critical care (London, England)",['10.1186/s13054-022-04055-4']
2364,35717239,Effect of negative pressure wound therapy after surgical removal of deep-seated high-malignant soft tissue sarcomas of the extremities and trunk wall-study protocol for a randomized controlled trial.,"BACKGROUND


Sarcomas are a heterogeneous group of rare malignant tumors of mesenchymal origin in the musculoskeletal system. The main treatment is surgery often supplemented with pre-or postoperative radiotherapy. A retrospective study by Bedi et al. indicated that negative pressure wound therapy (NPWT) reduced the risk of postoperative wound complications in patients treated with preoperative radiation followed by surgical tumor removal of lower extremity soft tissue sarcomas (STS), and the use of NPWT was not associated with an increased risk of local recurrence. Previous studies have shown that NPWT can reduce postoperative complications. STS surgeries are a high-risk procedure concerning wound complications.
METHODS


Non-blinded single-center randomized controlled trial comparing NPWT versus conventional wound dressing and postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall Sample-size calculation: 154 STS patients (80% risk of avoiding type II error, 5% risk of type I error, and an 80% wound complication risk) Block randomization of 8 into: Group A: Conventional wound dressing Group B: NPWT (PREVENA PLUS™ Incision Management System) Inclusion criteria: Surgery for a deep-seated STS of an extremity or the trunk wall Exclusion criteria: Age < 18 years, plastic surgery, low malignant/borderline STS, chemotherapy, preoperative radiotherapy, allergic/hypersensitive to acrylic adhesives or silver, unwilling/unable to provide informed consent, metastatic disease, and ischemic surgeries Primary study endpoints were set as major wound complications defined by O'Sullivan et al. as a secondary surgery under anesthesia for wound repairs and wound management without secondary surgery within 4 months postoperatively. Secondary study endpoints among others are Musculoskeletal Tumor Society Score (MSTS), Toronto Extremity Salvage Score (TESS), and European Quality of Life - 5 Dimensions (EQ-5D). Approval from the Scientific Ethical Committee and the Data Protection Agency has been obtained, and the study is registered at clinicaltrial.gov . This study did not apply for external funding.
DISCUSSION


Many new medical devices and technical solutions are currently being introduced, and even though some documentation regarding the use of NPWT, e.g., in joint replacement surgery exist, it is also important to seek documentation for this treatment principle in STS surgery.
TRIAL REGISTRATION


Registered at ClinicalTrials.gov NCT04960332 and approved on 11 July 2021.",2022,"Non-blinded single-center randomized controlled trial comparing NPWT versus conventional wound dressing and postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall Sample-size calculation: 154 STS patients (80% risk of avoiding type II error, 5% risk of type I error, and an 80% wound complication risk) Block randomization of 8 into: Group A:","[""Inclusion criteria: Surgery for a deep-seated STS of an extremity or the trunk wall Exclusion criteria: Age <\u200918\u2009years, plastic surgery, low malignant/borderline STS, chemotherapy, preoperative radiotherapy, allergic/hypersensitive to acrylic adhesives or silver, unwilling/unable to provide informed consent, metastatic disease, and ischemic surgeries Primary study endpoints were set as major wound complications defined by O'Sullivan et al"", 'patients treated with preoperative radiation followed by surgical tumor removal of lower extremity soft tissue sarcomas (STS', 'and postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall Sample-size calculation: 154 STS patients (80% risk of avoiding type II error, 5% risk of type I error, and an 80% wound complication risk) Block randomization of 8 into: Group A']","['negative pressure wound therapy', 'Conventional wound dressing Group B: NPWT (PREVENA PLUS™ Incision Management System', 'negative pressure wound therapy (NPWT', 'conventional wound dressing', 'NPWT', 'pre-or postoperative radiotherapy']","['postoperative complications', 'Musculoskeletal Tumor Society Score (MSTS), Toronto Extremity Salvage Score (TESS), and European Quality of Life - 5 Dimensions (EQ-5D']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0459558', 'cui_str': 'Body wall structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0558080', 'cui_str': 'Unwilling'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0877305', 'cui_str': 'Postoperative wound complication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.155527,"Non-blinded single-center randomized controlled trial comparing NPWT versus conventional wound dressing and postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall Sample-size calculation: 154 STS patients (80% risk of avoiding type II error, 5% risk of type I error, and an 80% wound complication risk) Block randomization of 8 into: Group A:","[{'ForeName': 'Müjgan', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Copenhagen, Rigshospitalet, Inge Lehmanns Vej 6, 2100, Copenhagen, Denmark. yilmaz_mujgan@hotmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Thorn', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Copenhagen, Rigshospitalet, Inge Lehmanns Vej 6, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Michala Skovlund', 'Initials': 'MS', 'LastName': 'Sørensen', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Copenhagen, Rigshospitalet, Inge Lehmanns Vej 6, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Claus Lindkær', 'Initials': 'CL', 'LastName': 'Jensen', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Copenhagen, Rigshospitalet, Inge Lehmanns Vej 6, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Michael Mørk', 'Initials': 'MM', 'LastName': 'Petersen', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Copenhagen, Rigshospitalet, Inge Lehmanns Vej 6, 2100, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-022-06468-6']
2365,35717662,Benefits of task-specific movement program on en bloc turning in Parkinson's disease: A randomized controlled trial.,"INTRODUCTION


En bloc turning highlights a lack of rotational intersegmental coordination, which commonly impacts turning ability in people with Parkinson's disease (PD). Whilst this turning deficit responds fairly well to medical treatment, it may be further mitigated by performing specific exercise training. Thus, the present study aimed to examine the effects of a 4-week exercise program, which focused on task-specific movements (TSM program) on turning ability and clinical outcomes in people with PD.
METHODS


Twenty-two adults (67 ± 6 years) with early-to-mid-stage idiopathic PD were randomly assigned to an experimental group (EG; n = 11) or a control group (CG; n = 11). The exercise group (EG) group received a 60-min per session TSM program for 4 weeks (a total of 15 sessions), while the CG group performed their routine rehabilitation program (a total of 12 sessions). Inertial measurement units were used to measure turning kinematics including; onset latency of body segments and stepping characteristics. Clinical outcomes included the Unified Parkinson's Disease Rating Scale (UPDRS), functional reach test (FRT), and fall efficacy scale international (FES-I). Assessments were conducted at baseline and after 4 weeks.
RESULTS


In the EG, turning kinematics, UPDRS scores, FRT, and FES-I scale, were improved at the end of the 4-week program compared with the CG (all p < 0.05).
IMPACT STATEMENT


A 4-week TSM program could be a promising alternative rehabilitation program for improving ""en bloc"" turns and clinical outcomes in PD patients.",2022,"In the EG, turning kinematics, UPDRS scores, FRT, and FES-I scale, were improved at the end of the 4-week program compared with the CG (all p < 0.05).
","['PD patients', ""people with Parkinson's disease (PD"", ""Parkinson's disease"", 'people with PD.\nMETHODS\n\n\nTwenty-two adults (67\xa0±\xa06\xa0years) with early-to-mid-stage idiopathic PD']","['CG group performed their routine rehabilitation program', 'task-specific movement program', 'task-specific movements (TSM program', '4-week exercise program', 'exercise group (EG) group received a 60-min per session TSM program']","['turning kinematics including; onset latency of body segments and stepping characteristics', ""Unified Parkinson's Disease Rating Scale (UPDRS), functional reach test (FRT), and fall efficacy scale international (FES-I"", 'turning kinematics, UPDRS scores, FRT, and FES-I scale']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.0309332,"In the EG, turning kinematics, UPDRS scores, FRT, and FES-I scale, were improved at the end of the 4-week program compared with the CG (all p < 0.05).
","[{'ForeName': 'Fuengfa', 'Initials': 'F', 'LastName': 'Khobkhun', 'Affiliation': 'College of Sports Science and Technology, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hollands', 'Affiliation': 'Brain and Behaviour Lab, Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Jarugool', 'Initials': 'J', 'LastName': 'Tretriluxana', 'Affiliation': 'Motor Control and Neural Plasticity Laboratory, Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Prachaya', 'Initials': 'P', 'LastName': 'Srivanitchapoom', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Richards', 'Affiliation': 'Allied Health Research Unit, School of Sport and Health Sciences, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Amornpan', 'Initials': 'A', 'LastName': 'Ajjimaporn', 'Affiliation': 'College of Sports Science and Technology, Mahidol University, Nakhon Pathom, Thailand.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1963']
2366,35717610,Smartphone-based home workout program for shift-work nurses working during the COVID-19 pandemic.,"This study aimed to develop a smartphone-based home workout program for shift-work nurses to increase their levels of exercise and examine its effects on health (sleep disturbance, fatigue, musculoskeletal problems, and resilience) and nursing performance. For this quasi-experimental study with a nonequivalent control group, 54 shift-work nurses were recruited from two general wards at a hospital in Korea and assigned to the intervention and control groups. Nurses in the intervention group were encouraged to exercise regularly using the home workout application for 18 weeks. For the first 12 weeks, text-message counseling and environmental improvement were carried out; only environmental improvement was implemented in the remaining 12-18 weeks. The control group did not receive any intervention. After excluding dropouts, the data of the final 25 participants in the intervention group and 24 participants in the control group were analyzed. Compared with the control group, the intervention group showed statistically significant improvements in physical and psychological health. Hospital organizations could adopt a smartphone-based home workout program to overcome obstacles to exercise, which could lead to positive health outcomes for shift-work nurses. This article is protected by copyright. All rights reserved.",2022,"Compared with the control group, the intervention group showed statistically significant improvements in physical and psychological health.",['54 shift-work nurses were recruited from two general wards at a hospital in Korea and assigned to the intervention and control groups'],"['Smartphone-based home workout program', 'smartphone-based home workout program']","['physical and psychological health', 'health (sleep disturbance, fatigue, musculoskeletal problems, and resilience) and nursing performance']","[{'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043030', 'cui_str': 'Wards, General'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",,0.0135361,"Compared with the control group, the intervention group showed statistically significant improvements in physical and psychological health.","[{'ForeName': 'Yunmi', 'Initials': 'Y', 'LastName': 'Baek', 'Affiliation': 'Chung-Ang University Graduate School, Seoul, South Korea.'}, {'ForeName': 'Kihye', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'Chung-Ang University College of Nursing, Seoul, South Korea.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University College of Nursing, Seoul, South Korea.'}, {'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Yoo', 'Affiliation': 'Chung-Ang University College of Nursing, Seoul, South Korea.'}]",Nursing & health sciences,['10.1111/nhs.12969']
2367,35717595,A network analysis in adolescent anorexia nervosa exploring the connection between both patient and carer reactions and outcome.,"OBJECTIVE


This paper used network analysis to test the associations between eating disorder-related psychopathology and carers' responses to anorexia nervosa symptoms in adolescents. Additionally, the prognostic value of central and bridge network nodes was explored.
METHOD


This is a secondary analysis of a three-armed randomised-controlled-trial of adolescents with anorexia nervosa (n = 149) and their primary carer (n = 149) who were allocated to either treatment as usual (TAU), or one of two versions of a carer skills intervention (ECHO) added to TAU. A network analysis was run in the full sample. The prognostic role of central and bridge nodes was tested through multiple regression analyses.
RESULTS


Carers' depression and emotional over-involvement, as well as patients' depression showed the highest strength centrality. Patients' depression and carers' accommodation exhibited the highest bridge expected influence. Across the full sample, and in the ECHO group, carers' accommodation predicted patients' higher body mass index (BMI), while patients' depression predicted worse psychosocial functioning at 1-year follow-up. In the ECHO group, higher carers' depression also predicted lower BMI.
CONCLUSIONS


Carers' accommodation and depression in both carers and patients were involved in the maintenance of psychopathology in adolescents with anorexia nervosa. Depression in both patients and carers is a potential treatment target for family interventions.",2022,"Across the full sample, and in the ECHO group, carers' accommodation predicted patients' higher body mass index (BMI), while patients' depression predicted worse psychosocial functioning at 1-year follow-up.","['adolescent anorexia nervosa', 'adolescents with anorexia nervosa (n\xa0=\xa0149) and their primary carer (n\xa0=\xa0149', ""eating disorder-related psychopathology and carers' responses to anorexia nervosa symptoms in adolescents"", 'adolescents with anorexia nervosa']","['usual (TAU), or one of two versions of a carer skills intervention (ECHO) added to TAU']",['psychosocial functioning'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]",[],149.0,0.188235,"Across the full sample, and in the ECHO group, carers' accommodation predicted patients' higher body mass index (BMI), while patients' depression predicted worse psychosocial functioning at 1-year follow-up.","[{'ForeName': 'Alessio Maria', 'Initials': 'AM', 'LastName': 'Monteleone', 'Affiliation': 'Department of Psychiatry, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Giammarco', 'Initials': 'G', 'LastName': 'Cascino', 'Affiliation': ""Department of Medicine, Surgery and Dentistry 'Scuola Medica Salernitana', Section of Neurosciences, University of Salerno, Salerno, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Salerno', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': ""Department of Psychological Medicine, Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Micali', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cardi', 'Affiliation': ""Department of Psychological Medicine, Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Department of Psychological Medicine, Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2933']
2368,35717531,Randomized trial of the effect of video training on residents' surgical skills in facial skin reconstructive surgery: A SQUIRE study.,"OBJECTIVES


The purpose of this study was to evaluate the impact of facial skin reconstruction training videos for head and neck and maxillofacial surgery residents.
MATERIAL AND METHODS


This randomized trial, conducted in France, involved residents in head and neck and maxillofacial surgery. A website was created containing facial skin reconstruction training videos. Selected residents performed facial skin flap dissections in the Paris School of Surgery. They were randomized into two groups, one receiving a standard course before the dissection, and the other a standard course plus a video of the flap (""no-video"" and ""video"" groups). Each resident performed 4 facial flaps and was graded (blindly) during dissection. The main study endpoint was intergroup difference in grading score (out of 15). The article was written up following the SQUIRE-EDU (Standards for QUality Improvement Reporting Excellence in EDUcation) criteria.
RESULTS


Eighteen residents were included. For the main endpoint, scores were significantly higher in the ""video"" than the ""no-video"" group (6 [IQR, 4: 9] vs. 10 [9: 12]; P<0.001). In addition, as secondary endpoint, ""no-video"" group residents requested more assistance (3 [2: 4] vs. 1 [1: 2] P<0.001). Power was lacking for any subgroup analysis according to year of residency or to the 4 flaps.
CONCLUSION


Videos improved surgical residents' performance during dissections. However, these results would be difficult to transpose to real clinical conditions. They need validating in a larger study evaluating performance in real-life procedures.",2022,"For the main endpoint, scores were significantly higher in the ""video"" than the ""no-video"" group (6 [IQR, 4: 9] vs. 10 [9: 12]; P<0.001).","['France, involved residents in head and neck and maxillofacial surgery', 'Selected residents performed facial skin flap dissections in the Paris School of Surgery', 'Eighteen residents were included', 'head and neck and maxillofacial surgery residents', ""residents' surgical skills in facial skin reconstructive surgery""]","['standard course plus a video of the flap (""no-video"" and ""video"" groups', 'facial skin reconstruction training videos', 'video training']","[""surgical residents' performance""]","[{'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",18.0,0.0538706,"For the main endpoint, scores were significantly higher in the ""video"" than the ""no-video"" group (6 [IQR, 4: 9] vs. 10 [9: 12]; P<0.001).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Morin', 'Affiliation': ""Service d'ORL, Hôpital René Dubos, Pontoise, France. Electronic address: louismanumorin@hotmail.com.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Couineau', 'Affiliation': ""Service d'ORL, Hôpital Foch, Suresnes, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Begon', 'Affiliation': 'Service de Dermatologie, Hôpital René Dubos, Pontoise, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Walter', 'Affiliation': 'Service de Dermatologie, Hôpital René Dubos, Pontoise, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Faucon', 'Affiliation': ""Service d'ORL, Hôpital René Dubos, Pontoise, France.""}, {'ForeName': 'K Al', 'Initials': 'KA', 'LastName': 'Tabaa', 'Affiliation': ""Service d'ORL, Hôpital René Dubos, Pontoise, France.""}]","European annals of otorhinolaryngology, head and neck diseases",['10.1016/j.anorl.2022.06.002']
2369,35717522,"Effect of Levofloxacin on the Efficacy and Adverse Events in Intravesical Bacillus Calmette-Guerin Treatment for Bladder Cancer: Results of a Randomized, Prospective, Multicenter Study.","BACKGROUND


Although bacillus Calmette-Guerin (BCG) is a standard treatment for high-risk non-muscle-invasive bladder cancer (NMIBC), a high rate of adverse events with a variety of grades remains a difficulty.
OBJECTIVE


In this randomized, prospective, multicenter study, we examined whether levofloxacin, given after each intravesical instillation of BCG, could improve its tolerance in patients with intermediate- to high-risk urothelial carcinoma of the bladder without compromising its efficacy.
DESIGN, SETTING, AND PARTICIPANTS


Overall, 106 Japanese patients (85 men and 21 women; age: median, 69.5 yr) with primary or recurrent NMIBC were randomized after transurethral resection to induce treatment with intravesical BCG plus levofloxacin (group 1) or BCG alone (group 2).
INTERVENTION


Patients who underwent intravesical instillation of BCG were randomized with or without levofloxacin administration.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Adverse events were assessed using the National Cancer Institute-Common Toxicity Criteria version 3.0. Cumulative incidence functions and Kaplan-Meier methods were applied to estimate survival outcomes.
RESULTS AND LIMITATIONS


There was no significant difference in baseline characteristics between the groups. The completion rate of group 1 (85.5%) was not significantly lower than that of group 2 (76.5%; p = 0.321). There was no significant difference in the completion rate of patients with pollakisuria, painful micturition, gross hematuria, fever elevation, and others between the groups. The incidence of adverse events in patients with high-grade pollakisuria (7.3% vs 25.4%, p = 0.041) and fever (0% vs 9.1%, p = 0.034) was significantly lower in group 1. The 5-yr progression-free and cancer-specific survival rates were significantly better in group 1.
CONCLUSIONS


Prophylactic levofloxacin administration may reduce the severity of adverse events and contribute to better outcomes from BCG intravesical therapy in patients with NMIBC.
PATIENT SUMMARY


Levofloxacin administration seems to be a safe and effective therapy for non-muscle-invasive bladder cancer patients treated with bacillus Calmette-Guerin intravesical therapy.",2022,"There was no significant difference in the completion rate of patients with pollakisuria, painful micturition, gross hematuria, fever elevation, and others between the groups.","['106 Japanese patients (85 men and 21 women; age: median, 69.5 yr) with primary or recurrent NMIBC', 'patients with intermediate- to high-risk urothelial carcinoma of the bladder without compromising its efficacy', 'Bladder Cancer', 'patients with NMIBC', 'non-muscle-invasive bladder cancer patients treated with bacillus Calmette-Guerin intravesical therapy']","['BCG', 'Intravesical Bacillus Calmette-Guerin Treatment', 'transurethral resection to induce treatment with intravesical BCG plus levofloxacin', 'bacillus Calmette-Guerin (BCG', 'intravesical instillation of BCG', 'Levofloxacin', 'levofloxacin', 'BCG alone', 'levofloxacin administration']","['completion rate of patients with pollakisuria, painful micturition, gross hematuria, fever elevation', '5-yr progression-free and cancer-specific survival rates', 'severity of adverse events', 'completion rate', 'Adverse events', 'fever', 'incidence of adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C1289970', 'cui_str': 'Intravesical BCG'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0473237', 'cui_str': 'Frank hematuria'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",106.0,0.0515257,"There was no significant difference in the completion rate of patients with pollakisuria, painful micturition, gross hematuria, fever elevation, and others between the groups.","[{'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Numakura', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. Electronic address: nqf38647@nifty.com.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Ishida', 'Affiliation': 'Department of Urology, Akita City Hospital, Akita, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Okane', 'Affiliation': 'Department of Urology, Akita Kousei Medical Center, Akita, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Kakunodate General Hospital, Senboku, Japan.'}, {'ForeName': 'Naotake', 'Initials': 'N', 'LastName': 'Shimoda', 'Affiliation': 'Department of Urology, Japanese Red Cross Akita Hospital, Akita, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Hiraka General Hospital, Yokote, Japan.'}, {'ForeName': 'Teruaki', 'Initials': 'T', 'LastName': 'Kumazawa', 'Affiliation': 'Department of Urology, Omagari Kousei Medical Center, Daisen, Japan.'}, {'ForeName': 'Ryusei', 'Initials': 'R', 'LastName': 'Sasaki', 'Affiliation': 'Department of Urology, Kitaakita Municipal Hospital, Kitaakita, Japan.'}, {'ForeName': 'Hisami', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Department of Urology, Fujiwara Memorial Hospital, Katagami, Japan.'}, {'ForeName': 'Soki', 'Initials': 'S', 'LastName': 'Kashima', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Koizumi', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Taketoshi', 'Initials': 'T', 'LastName': 'Nara', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Kanda', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Mingguo', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Narita', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Takamitsu', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Renal and Urological Surgery, International University of Health and Welfare, Narita, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Habuchi', 'Affiliation': 'Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.'}]",European urology focus,['10.1016/j.euf.2022.06.002']
2370,35712124,The Impact of VR-CALM Intervention Based on VR on Psychological Distress and Symptom Management in Breast Cancer Survivors.,"Objective


To evaluate the effectiveness and feasibility of Managing Cancer and Living Meaningfully based on VR (VR-CALM), which is used to manage expected symptoms of cancer itself, relieve psychological distress, and improve quality of life (QOL) in the Chinese breast cancer survivors (BCs).
Methods


Ninety-eight patients with breast cancer were recruited in this study. These patients were randomly assigned to the VR-CALM group or the care as usual (CAU) group. All patients were evaluated by the Functional Assessment of Cancer Therapy-Breast cancer patient (FACT-B), Distress Thermometer (DT), Concerns About Recurrence Scale (CARS), Piper Fatigue Scale (PFS), Pittsburgh Sleep Quality Index (PSQI), The Self-Rating Anxiety Scale (SAS), and The Self-Rating Depression Scale (SDS) before and after VR-CALM or CAU application to BCs. We compared the differences in all these scores between the VR-CALM group and the control group.
Results


Patients in the VR-CALM group showed a significant decrease in levels of distress, anxiety, depression, sleep disorders, and fatigue ( t  = -6.829,  t  = -5.819,  t  = -2.094,  t  = -3.031,  t  = -10.082,  P  ≤ 0.001, 0.001, 0.05, 0.01, 0.001, respectively) and had higher level of quality of life ( t  = 8.216,  P  ≤ 0.001) compared with the CAU group after intervention. And postintervention patients in VR-CALM group compared with preintervention showed lower level of distress and remarkable improvement of QOL ( t  = 11.521,  t  = -10.379,  P  ≤ 0.001, 0.001). The preintervention questionnaire revealed no significant between-group differences regarding distress, anxiety, depression, sleep disorders, fatigue, and quality of life.
Conclusion


VR-CALM is a psychotherapy tailored to the needs of patients with breast cancer. This research innovatively used VR-based CALM intervention to improve psychological and chronic symptoms in BCs. The results of the present study indicate that VR-CALM has salutary effects on the improvement of QOL and relieves psychological distress, anxiety, depression, sleep disorders, and fatigue in BCs.",2022,"Results


Patients in the VR-CALM group showed a significant decrease in levels of distress, anxiety, depression, sleep disorders, and fatigue ( t  = -6.829,  t  = ","['patients with breast cancer', 'Methods\n\n\nNinety-eight patients with breast cancer', 'Chinese breast cancer survivors (BCs', 'Breast Cancer Survivors']","['VR-CALM Intervention', 'Managing Cancer and Living Meaningfully based on VR (VR-CALM', 'CAU', 'VR-based CALM intervention', 'VR-CALM group or the care as usual (CAU']","['QOL', 'levels of distress, anxiety, depression, sleep disorders, and fatigue', 'quality of life (QOL', 'higher level of quality of life', 'QOL and relieves psychological distress, anxiety, depression, sleep disorders, and fatigue in BCs', 'Functional Assessment of Cancer Therapy-Breast cancer patient (FACT-B), Distress Thermometer (DT), Concerns About Recurrence Scale (CARS), Piper Fatigue Scale (PFS), Pittsburgh Sleep Quality Index (PSQI), The Self-Rating Anxiety Scale (SAS), and The Self-Rating Depression Scale (SDS', 'level of distress', 'distress, anxiety, depression, sleep disorders, fatigue, and quality of life', 'Psychological Distress and Symptom Management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",98.0,0.0382451,"Results


Patients in the VR-CALM group showed a significant decrease in levels of distress, anxiety, depression, sleep disorders, and fatigue ( t  = -6.829,  t  = ","[{'ForeName': 'Xiuqing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Senbang', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Menglian', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Xiangxiang', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Ziran', 'Initials': 'Z', 'LastName': 'Bi', 'Affiliation': 'Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Jing', 'Affiliation': 'Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Huaidong', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}]",Journal of oncology,['10.1155/2022/1012813']
2371,35712110,Acupuncture Analgesia in Patients With Traumatic Rib Fractures: A Randomized-Controlled Trial.,"Pain management for traumatic rib fracture is important to prevent complications and reduce associated comorbidities. This trial investigated the analgesic efficacy of acupuncture on traumatic rib fracture. Patients with traumatic rib fracture were randomly assigned to traditional acupuncture (TA), laser acupuncture (LA) or sham laser acupuncture (SLA) groups in a 1:1:1 ratio. The intervention was performed on days 1 to 3 after treatment allocation. The acupoints included bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan). The primary outcome was Numeric Rating Scale (NRS) scores for pain after the intervention. Secondary outcomes included sustained maximal inspiration (SMI) lung volume, stress responses, the use of analgesics, and associated complications. Data were analyzed via one-way analysis of variance (ANOVA) with Scheffé's  post hoc  testing or chi-squared testing. Of the 120 study participants, 109 completed all interventions and measurements. The primary outcomes, which indicated average pain intensity levels and pain while deep breathing, were both significantly lower in the TA and LA groups than in the SLA group after 2 treatments. No between-group differences were observed in SMI lung volume, stress response, analgesics use or associated complications. These findings suggest that TA and LA are safe and effective analgesic modalities for pain management for traumatic rib fracture.
Clinical Trial Registration


[ClinicalTrials.gov], identifier [NCT03822273].",2022,"The primary outcomes, which indicated average pain intensity levels and pain while deep breathing, were both significantly lower in the TA and LA groups than in the SLA group after 2 treatments.","['Patients With Traumatic Rib Fractures', 'traumatic rib fracture', '120 study participants, 109 completed all interventions and measurements', 'Patients with traumatic rib fracture']","['traditional acupuncture (TA), laser acupuncture (LA) or sham laser acupuncture (SLA', 'SLA', 'acupuncture', 'Acupuncture Analgesia', 'TA and LA']","['SMI lung volume, stress response, analgesics use or associated complications', 'bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan', 'sustained maximal inspiration (SMI) lung volume, stress responses, the use of analgesics, and associated complications', 'analgesic efficacy', 'average pain intensity levels and pain while deep breathing', 'Numeric Rating Scale (NRS) scores for pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001300', 'cui_str': 'Acupuncture for analgesia'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0450480', 'cui_str': 'LI4'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0450754', 'cui_str': 'GB34'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.149084,"The primary outcomes, which indicated average pain intensity levels and pain while deep breathing, were both significantly lower in the TA and LA groups than in the SLA group after 2 treatments.","[{'ForeName': 'Chun-Ting', 'Initials': 'CT', 'LastName': 'Liu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Ting-Min', 'Initials': 'TM', 'LastName': 'Hsieh', 'Affiliation': 'Division of Trauma, Department of Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Bei-Yu', 'Initials': 'BY', 'LastName': 'Wu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Yu-Chuen', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Integrated Medicine, School of Chinese Medicine, College of Chinese Medicine, Research Center for Chinese Medicine & Acupuncture, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chun-Han', 'Initials': 'CH', 'LastName': 'Shih', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Wen-Long', 'Initials': 'WL', 'LastName': 'Hu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Ming-Yen', 'Initials': 'MY', 'LastName': 'Tsai', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Yung-Hsiang', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Integrated Medicine, School of Chinese Medicine, College of Chinese Medicine, Research Center for Chinese Medicine & Acupuncture, China Medical University, Taichung, Taiwan.'}]",Frontiers in medicine,['10.3389/fmed.2022.896692']
2372,35712058,The Relationships Between Glycated Hemoglobin and Bone Turnover Markers in Patients with Type 2 Diabetes but No Diabetic Nephropathy.,"Purpose


To investigate the relationships between glycated hemoglobin (HbA1c) level and bone turnover markers (BTMs) in patients with type 2 diabetes mellitus (T2DM) but no diabetic nephropathy.
Patients and Methods


Patients with T2DM were recruited at Hebei General Hospital in China. The participants were allocated to three groups: an HbA1c <7% group, an HbA1c 7%-9% group, and an HbA1c ≥9% group. Their general characteristics, biochemical indices, and BTM concentrations were recorded.
Results


The ages of the HbA1c <7% group and the HbA1c 7%-9% group were significantly higher than that of the HbA1c ≥9% group ( P <0.05). The prevalence of a history of hypertension in the HbA1c 7%-9% group was significantly higher than that in the HbA1c ≥9% group. The circulating low-density lipoprotein-cholesterol concentration in the HbA1c ≥9% group and the apolipoprotein B concentration in the HbA1c 7%-9% group were significantly higher than those in the HbA1c <7% group ( P <0.05). Compared with that in the HbA1c <7% group, the circulating 25-hydroxyvitamin D (25OHD) concentration was significantly lower in the HbA1c ≥9% group ( P <0.05). Additionally, the circulating 25OHD and osteocalcin (OC) concentrations negatively correlated with HbA1c ( P <0.05).
Conclusion


An increase in HbA1c is associated with gradual decreases in the circulating concentrations of 25OHD and OC.",2022,The prevalence of a history of hypertension in the HbA1c 7%-9% group was significantly higher than that in the HbA1c ≥9% group.,"['Patients and Methods\n\n\nPatients with T2DM were recruited at Hebei General Hospital in China', 'patients with type 2 diabetes mellitus (T2DM) but no diabetic nephropathy', 'Patients with Type 2 Diabetes but No Diabetic Nephropathy']",[],"['apolipoprotein B concentration', 'Glycated Hemoglobin and Bone Turnover Markers', 'prevalence of a history of hypertension', 'glycated hemoglobin (HbA1c) level and bone turnover markers (BTMs', 'circulating low-density lipoprotein-cholesterol concentration', 'biochemical indices, and BTM concentrations', 'circulating 25-hydroxyvitamin D (25OHD) concentration', 'circulating concentrations of 25OHD and OC', 'circulating 25OHD and osteocalcin (OC) concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}]",[],"[{'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}]",,0.0397703,The prevalence of a history of hypertension in the HbA1c 7%-9% group was significantly higher than that in the HbA1c ≥9% group.,"[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ""Endocrinology Department, Hebei General Hospital, Shijiazhuang, Hebei, 050051, People's Republic of China.""}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Graduate School of Hebei Medical University, Shijiazhuang, Hebei, 050017, People's Republic of China.""}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhen', 'Affiliation': ""Endocrinology Department, Hebei General Hospital, Shijiazhuang, Hebei, 050051, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Endocrinology Department, Hebei General Hospital, Shijiazhuang, Hebei, 050051, People's Republic of China.""}]",International journal of general medicine,['10.2147/IJGM.S366725']
2373,35712039,Telehealth education improves parental care ability and postoperative nutritional status of infants after CHD surgery: A prospective randomized controlled study.,"Objective


This study aimed to explore the effect of telehealth education on improving the parental care ability and postoperative nutritional status of infants after congenital heart disease surgery.
Methods


A prospective randomized controlled study was conducted at a provincial maternal and child hospital in southeastern China. A total of 84 infants were enrolled in the study, with 42 infants in the intervention group and 42 infants in the control group.
Results


Body weight, albumin, prealbumin, and hemoglobin of infants in the intervention group were significantly higher than those in the control group one month after discharge (P<0.05). The STRONGkids score of infants in the intervention group was significantly higher than that of those in the control group one month after discharge (P<0.05). The Family Caregiver Task Inventory score of infants in the intervention group was significantly lower than that of those in the control group one month after discharge (P<0.05).
Conclusion


Performing telehealth education about home feeding and care guidance for parents of infants after congenital heart disease surgery can greatly improve parental care ability so that infants get better feeding and care, which can effectively improve the postoperative nutritional status of the infants.",2022,"The Family Caregiver Task Inventory score of infants in the intervention group was significantly lower than that of those in the control group one month after discharge (P<0.05).
","['infants after CHD surgery', 'infants after congenital heart disease surgery', 'parents of infants after congenital heart disease surgery', '84 infants were enrolled in the study, with 42 infants in the intervention group and 42 infants in the control group', 'provincial maternal and child hospital in southeastern China']","['telehealth education', 'Telehealth education']","['parental care ability and postoperative nutritional status', 'Body weight, albumin, prealbumin, and hemoglobin', 'Family Caregiver Task Inventory score']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",84.0,0.0155137,"The Family Caregiver Task Inventory score of infants in the intervention group was significantly lower than that of those in the control group one month after discharge (P<0.05).
","[{'ForeName': 'Qi-Liang', 'Initials': 'QL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Yu-Qing', 'Initials': 'YQ', 'LastName': 'Lei', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",Paediatrics & child health,['10.1093/pch/pxab094']
2374,35712008,Effect of Psychological Intervention-Assisted Comfort Nursing Based on PERMA Model on Stress and Psychological Changes of Patients after Breast Cancer Surgery.,"Objective


To investigate the emotional response, stress and psychological changes of patients with breast cancer after surgery for psychological intervention-assisted comfort nursing based on the PERMA model.
Methods


A total of 100 postoperative breast cancer patients admitted to our hospital from March 2019 to June 2021 were selected as prospective research objects. According to a random number table, they were divided into a control group and an observation group with 50 cases each. Among them, the control group implemented routine nursing care, and the observation group implemented psychological intervention-assisted comfort care based on the PERMA model on the basis of the control group. The differences in compliance behavior, self-care ability, emotional response, stress response changes, and pain scores of the two groups of breast cancer patients before and after nursing were compared.
Results


After nursing, the mental behavior scores, exercise scores, medication scores, and balanced diet scores of the two groups of breast cancer patients after surgery were significantly improved. The observation group's compliance behavior scores were significantly higher than those of the control group. In the two groups of breast cancer patients, postoperative anxiety, depression, fatigue, and anger of the patients were significantly improved, and the emotional response score of the observation group was significantly lower than that of the control group. The self-care skill score, self-responsibility score, health knowledge score, and self-concept score of the observation group were excellent compared with those of the control group; the difference was significant by the above statistics ( P  < 0.05). The HR and MAP of the control group during the operation were higher than those 1 day before the start of the operation and decreased at the end of the operation, but still higher than the level 1 day before the start of the operation; the change trend of the observation group was the same as that of the control group, but there were differences between the time points. There was no significant significance ( P  > 0.05). The HR and MAP of the observation group during the operation were lower than those of the control group, and the MAP at the end of the operation was lower than that of the control group. This difference was statistically significant ( P  < 0.05). In the control group, the values increased at the time point during the operation and decreased at the end of the operation, but still higher than the level 1 day before the operation. The difference was statistically significant ( P  < 0.05). The change trend of the observation group was the same as that of the control group; and the values during and at the end of the operation were all lower than those of the control group. This difference was statistically significant ( P  < 0.05). The pain scores of the two groups of patients at different time points were significantly improved, and the observation group was significantly less than the control group. This difference was statistically significant ( P  < 0.05).
Conclusion


Psychological intervention-assisted comfort nursing can effectively enhance the compliance behavior of patients after breast cancer surgery, improve the emotional response, stress response, and pain of patients, and have certain reference value for the nursing of patients after breast cancer surgery.",2022,"The HR and MAP of the control group during the operation were higher than those 1 day before the start of the operation and decreased at the end of the operation, but still higher than the level 1 day before the start of the operation; the change trend of the observation group was the same as that of the control group, but there were differences between the time points.","['100 postoperative breast cancer patients admitted to our hospital from March 2019 to June 2021 were selected as prospective research objects', 'patients after breast cancer surgery', 'patients with breast cancer after surgery for psychological intervention-assisted comfort nursing based on the PERMA model', 'Patients after Breast Cancer Surgery']","['routine nursing care, and the observation group implemented psychological intervention-assisted comfort care based on the PERMA model', 'Psychological intervention-assisted comfort nursing', 'Psychological Intervention-Assisted Comfort Nursing Based on PERMA Model']","['compliance behavior scores', 'pain scores', 'emotional response, stress and psychological changes', 'emotional response score', 'postoperative anxiety, depression, fatigue, and anger', 'Stress and Psychological Changes', 'self-care skill score, self-responsibility score, health knowledge score, and self-concept score', 'mental behavior scores, exercise scores, medication scores, and balanced diet scores', 'compliance behavior, self-care ability, emotional response, stress response changes, and pain scores', 'emotional response, stress response, and pain', 'HR and MAP']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0452410', 'cui_str': 'Balanced diet'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",,0.0277797,"The HR and MAP of the control group during the operation were higher than those 1 day before the start of the operation and decreased at the end of the operation, but still higher than the level 1 day before the start of the operation; the change trend of the observation group was the same as that of the control group, but there were differences between the time points.","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Huzhou Traditional Chinese Medicine Hospital, The Operating Room of Huzhou City Hospital in Wuxing District, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Luo', 'Affiliation': 'Operating Room, Wuhan No. 3 Hospital, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Cai', 'Affiliation': 'Huzhou Traditional Chinese Medicine Hospital, The Operating Room of Huzhou City Hospital in Wuxing District, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'The Center Hospital of Wuhan, China.'}, {'ForeName': 'DongQin', 'Initials': 'D', 'LastName': 'Liang', 'Affiliation': ""Department of Neurosurgery, People's Hospital of Dongxihu District, Wuhan, Hubei 430040, China.""}, {'ForeName': 'YuJie', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Hospital Infection-Control Department, People's Hospital of Dongxihu District, Wuhan, Hubei 430040, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/1853754']
2375,35712396,Vertical Bone Implant Contact Around Anterior Immediate Implants and Their Stability After Using Either Alloplast or L-PRF or Both in Peri-Implant Gap: A Prospective Randomized Trial.,"Purpose


Various graft materials have been studied for filling peri-implant gap (PIG), but there was no similar randomized clinical trial to evaluate the effect of Platelet-rich fibrin or alloplast or their combination on vertical bone implant contact (BIC) around immediate implants and their stability over a period of 1 year.
Methods


Immediate implants were placed in maxillary anterior region of 30 subjects ( n  = 10). Either alloplast (group I) or L-PRF (group II) or both (group III) were used to fill the PIG following randomization chart. Vertical BIC was measured on peri-apical radiographs which were taken immediately after placement, after 3, 6 and 12 months using Image J software. Periotest was used to measure the implant stability at the time of implant placement, at 3, 6 and 12 months after implantation.
Results


The comparison of distance from implant shoulder to the first visible bone-to-implant contact (IS-BIC) in each group showed statistically significant bone formation on mesial and distal sides over a 1 year period ( p  < 0.05). There was no significant difference in IS-BIC distance among the three groups at 1 year ( p  > 0.05). Periotest values showed that there was significant improvement in implant stability in all groups in 1-year period. On intergroup comparison, the mean difference of periotest values was statistically non-significant among three groups ( p  > 0.05).
Conclusions


All the graft materials were effective in promoting osseointegration when used as PIG filling materials alone or in combination around immediate implants in maxillary anterior region.
CTRI No


REF/2015/06/009200.",2022,There was no significant difference in IS-BIC distance among the three groups at 1 year ( p  > 0.05).,[],"['Alloplast or L-PRF', 'alloplast (group I) or L-PRF']","['implant stability', 'bone formation on mesial and distal sides', 'IS-BIC distance', 'Vertical BIC', 'periotest values']",[],"[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0441843', 'cui_str': 'Group I'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0097799,There was no significant difference in IS-BIC distance among the three groups at 1 year ( p  > 0.05).,"[{'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Shahbaz Alam', 'Affiliation': 'Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, 110029 India.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Dhiman', 'Affiliation': 'Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, 110029 India.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Prosthodontics, CDER, AIIMS, New Delhi, 110029 India.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi, 110029 India.'}, {'ForeName': 'Gunjan', 'Initials': 'G', 'LastName': 'Pruthi', 'Affiliation': 'Department of Prosthodontics, Oral Health Sciences Center, PGIMER, Chandigarh, India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01426-8']
2376,35712390,Effectiveness of Anterior and Middle Superior Alveolar Nerve Block for Anesthesia of Maxillary Teeth Using Conventional Syringe: A Randomized Prospective Study.,"Aim


To study the effectiveness of anterior and middle superior alveolar nerve block (AMSA) for anesthesia of unilateral maxillary teeth, i.e., from central incisor to second premolar of the same side by using conventional syringe and needle.
Material and Method


Two hundred patients who needed extraction of any tooth/teeth in the region of central incisor to second premolar of the same side were randomly chosen for the study.
Result


Successful anesthesia was found in 71.5% of cases. However, the highest success rate was seen with first premolar (82.2%) and minimum with lateral incisor (67.5%), and induction time ranged from 6 to 12 min and duration for 30-45 min.
Conclusion


Using conventional syringe and needle, AMSA can be administered to achieve adequate soft tissue anesthesia of maxillary central incisors, canine and premolars of that side and pulpal anesthesia to a good extent (more so with first premolar), without affecting the muscles of facial expressions and lip numbness, reducing the requirement of multiple injections for the same.",2022,"However, the highest success rate was seen with first premolar (82.2%) and minimum with lateral incisor (67.5%), and induction time ranged from 6 to 12 min and duration for 30-45 min.
",['Two hundred patients who needed extraction of any tooth/teeth in the region of central incisor to second premolar of the same side were randomly chosen for the study'],"['Anterior and Middle Superior Alveolar Nerve Block', 'anterior and middle superior alveolar nerve block (AMSA', 'Conventional Syringe', 'conventional syringe and needle, AMSA']",['highest success rate'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0394796', 'cui_str': 'Local anesthetic middle superior alveolar nerve block'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0205250', 'cui_str': 'High'}]",200.0,0.0289191,"However, the highest success rate was seen with first premolar (82.2%) and minimum with lateral incisor (67.5%), and induction time ranged from 6 to 12 min and duration for 30-45 min.
","[{'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Chourasia', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Rishiraj College of Dental Sciences and Research Centre, Bhopal, Bhopal, MP India.'}, {'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Vastani', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Rishiraj College of Dental Sciences and Research Centre, Bhopal, Bhopal, MP India.'}, {'ForeName': 'Vedant', 'Initials': 'V', 'LastName': 'Pahlajani', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Rishiraj College of Dental Sciences and Research Centre, Bhopal, Bhopal, MP India.'}, {'ForeName': 'Arpan', 'Initials': 'A', 'LastName': 'Shrivastav', 'Affiliation': 'Department of Community Dentistry, Rishiraj College of Dental Sciences and Research Centre, Bhopal, Bhopal, MP India.'}, {'ForeName': 'Suryakant', 'Initials': 'S', 'LastName': 'Choubey', 'Affiliation': 'Sagar, MP India.'}, {'ForeName': 'Samarth', 'Initials': 'S', 'LastName': 'Vajpayee', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Rishiraj College of Dental Sciences and Research Centre, Bhopal, 57, Surya-Ganga A.B. Road, Shajapur, MP 465001 India.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Rishiraj College of Dental Sciences and Research Centre, Bhopal, Bhopal, MP India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01432-w']
2377,35712386,The Efficacy of Fixation of Unilateral Mandibular Angle Fracture with Single 3D Plate vs Single Miniplate Using Transbuccal Approach.,"Introduction


The management of mandibular angle fractures is often challenging and results in the highest rate of complications. The optimal treatment modality still remains controversial. This study was done to compare the treatment outcomes of single 3D plate versus single miniplate.
Objective


The objective was to compare and evaluate the clinical and radiological outcome in patients who underwent treatment with single 3D plate versus single miniplate using transbuccal approach for unilateral angle fractures with other associated mandibular fractures.
Methodology


A randomized control study was done in 12 patients with unilateral angle fracture who were divided into two groups. Group A patients were treated using single 3D plates, and Group B patients were treated using single miniplates. Study parameters were evaluated at different time intervals.
Results


The results of the study showed that postoperatively in Group A, fracture reduction, occlusion and mouth opening were comparatively better than Group B. Hardware failure was seen in one patient in Group B. Postoperative morbidities showed no statistical difference.
Conclusion


The single 3D plates showed a statistically insignificant advantage over single miniplates, although clinically Group A proved better than Group B with respect to the study parameters. Therefore, we recommend the use of single 3D plates for effective unilateral angle fracture treatment. More studies are required to prove the significant statistical significance.",2022,"The single 3D plates showed a statistically insignificant advantage over single miniplates, although clinically Group A proved better than Group B with respect to the study parameters.","['for unilateral angle fractures with other associated mandibular fractures', 'patients who underwent treatment with', '12 patients with unilateral angle fracture who were divided into two groups']","['single 3D plate versus single miniplate', 'single 3D plate versus single miniplate using transbuccal approach', 'Fixation of Unilateral Mandibular Angle Fracture with Single 3D Plate vs Single Miniplate Using Transbuccal Approach']","['fracture reduction, occlusion and mouth opening']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}]",12.0,0.0156305,"The single 3D plates showed a statistically insignificant advantage over single miniplates, although clinically Group A proved better than Group B with respect to the study parameters.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Mathew', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Christian Dental College, CMC, Ludhiana, Punjab 141008 India.'}, {'ForeName': 'Inderjot', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Christian Dental College, CMC, Ludhiana, Punjab 141008 India.'}, {'ForeName': 'Sumir', 'Initials': 'S', 'LastName': 'Gandhi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Christian Dental College, CMC, Ludhiana, Punjab 141008 India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Solanki', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Christian Dental College, CMC, Ludhiana, Punjab 141008 India.'}, {'ForeName': 'Navpreet Singh', 'Initials': 'NS', 'LastName': 'Bedi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Christian Dental College, CMC, Ludhiana, Punjab 141008 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01465-1']
2378,35712384,A Prospective Randomized Study to Assess the Quality of Life in Post-Operative Recovery Phase in Patients Undergoing Surgery for Isolated Vertically Undisplaced Mandibular Parasymphysis Fracture Using Twin Mix Solution.,"Purpose


Trauma is a major cause for facial fractures commonly encountered by maxillofacial surgeons. Mandible is commonly involved in facial trauma resulting in an isolated fracture or associated with other facial bones due to its prominent location in the facial skeleton. This study was undertaken to investigate the quality of life (QoL) post-operatively in patients diagnosed with undisplaced parasymphysis fracture who underwent open reduction and internal fixation (ORIF) under local anesthesia (LA) using the twin mix (TM) solution.
Patients and Methods


A prospective randomized clinical study was conducted among 40 patients aged between 20-55 years requiring ORIF for unilateral vertically undisplaced parasymphysis fracture under LA. Group A patients ( n  = 20) received conventional LA solution with adrenaline, and Group B patients ( n  = 20) received freshly prepared TM solution for their surgical intervention as a day care procedure. Various parameters such as jaw function, ability to masticate and labialis activity (lower lip pout) were assessed. The data were collected and analyzed applying student's  t  test, Shapiro-Wilk test using SPSS software.
Results


All the 20 patients in Group B who received TM solution exhibited better jaw function and mouth opening with a mean score of (±SD) of 4.55 (±0.944). They also exhibited reduced difficulty in mastication and ability to purse the lower lip on third post-operative day as compared to the patients in Group A. No complications were observed among the patients post-operatively in both the groups of this study.
Conclusion


TM solution proves to be superior as compared to the conventional LA solution as the former offers an improved clinical outcomes enhancing the QoL post-operatively in patients undergoing ORIF for undisplaced parasymphysis mandibular fracture.",2022,"They also exhibited reduced difficulty in mastication and ability to purse the lower lip on third post-operative day as compared to the patients in Group A. No complications were observed among the patients post-operatively in both the groups of this study.
","['patients diagnosed with undisplaced parasymphysis fracture who underwent', 'Patients Undergoing Surgery for Isolated Vertically Undisplaced Mandibular Parasymphysis Fracture', '40 patients aged between 20-55\xa0years requiring ORIF for unilateral vertically undisplaced parasymphysis fracture under LA']","['TM solution', 'open reduction and internal fixation (ORIF) under local anesthesia (LA) using the twin mix (TM) solution', 'conventional LA solution with adrenaline', 'freshly prepared TM solution']","['quality of life (QoL', 'jaw function, ability to masticate and labialis activity (lower lip pout', 'jaw function and mouth opening with a mean score of (±SD', 'Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443336', 'cui_str': 'Undisplaced'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0226942', 'cui_str': 'External lower lip'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0350027,"They also exhibited reduced difficulty in mastication and ability to purse the lower lip on third post-operative day as compared to the patients in Group A. No complications were observed among the patients post-operatively in both the groups of this study.
","[{'ForeName': 'Darpan', 'Initials': 'D', 'LastName': 'Bhargava', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, People's College of Dental Sciences and Research Center, People's University, Bhanpur, Bhopal, Madhya Pradesh 462037 India.""}, {'ForeName': 'Sivakumar', 'Initials': 'S', 'LastName': 'Beena', 'Affiliation': 'TMJ Consultancy Services (SEA), H-3/2, B.D.A Colony, Nayapura, Lal Ghati, Airport Road, Bhopal, Madhya Pradesh 462 001 India.'}, {'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Ahirwal', 'Affiliation': 'Department of Anesthesia and Critical Care, Gandhi Medical College and Hospitals, Bhopal, Madhya Pradesh India.'}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Sharma', 'Affiliation': 'Department of Dentistry, Netaji Subhash Chandra Bose Medical College, Tilwara Road, Doctors Colony, Medical College Colony, Jabalpur, Madhya Pradesh 482003 India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Dalsingh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Lenora Institute of Dental Sciences, Rajhamundry, Andhra Pradesh India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ""Department of Conservative Dentistry and Endodontics, People's College of Dental Sciences and Research Center, People's University, Bhanpur, Bhopal, Madhya Pradesh 462037 India.""}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01471-3']
2379,35712291,Effectiveness and Usability of a Novel Kinect-Based Tailored Interactive Fall Intervention System for Fall Prevention in Older People: A Preliminary Study.,"Falls are prevalent among older people and can lead to serious health problems. We newly developed a novel Kinect-based tailored interactive fall intervention system, which seamlessly integrates multifactorial fall risk assessment and tailored intervention programs to prevent falls in older people. This preliminary study aimed to examine the effectiveness and usability of this developed system for fall prevention in older people. Thirty community-dwelling older women participated in this experiment; they were allocated to an intervention group (IG) or a control group (CG) for a quasi-randomized trial (15 people each). Participants in IG followed an 8-week tailored intervention (40 min/session × 2 sessions/week × 8 weeks) using the Kinect-based interactive fall intervention system, while participants in CG maintained their habitual activities. Various outcome measures were evaluated at baseline (Week 0), interim (Week 4), and post-intervention (Week 8). Experimental results showed that IG led to significant improvements in TUG-Timed Up and Go ( p  = 0.010), BBS-Berg Balance Scale ( p  = 0.011), and Montreal Cognitive Assessment-MoCA ( p  = 0.022) between baseline and post-intervention. In comparison to the baseline, TUG and BBS were even significantly improved at interim ( p  = 0.004 and 0.047, respectively). There were no significant changes in static balance-related performance outcomes and the Short Falls Efficacy Scale-SFES after the intervention. Whereas in CG, most performance measures did not show significant changes during the 8-week period, TUG completion time became significantly longer at post-intervention in comparison to interim ( p  = 0.028) and fear of falling was also significantly higher at post-intervention than baseline ( p  = 0.021). These findings suggest that the Kinect-based 8-week tailored interactive fall interventions effectively improved older people's physical and cognitive abilities. Regarding the usability of the developed system, the average System Usability Scale (SUS) score was 83.5 out of 100, indicating excellent system usability. The overall mean Computer Literacy Scale (CLS) score was 2.5 out of 26, showing that older participants in this study had very limited experience with computers. No significant correlation between SUS and CLS scores demonstrated that newly developed Kinect-based tailored interactive fall intervention system was easy to use for older people, regardless of their computer experience. This novel system should help health professionals and older people proactively manage the risk of falls.",2022,There were no significant changes in static balance-related performance outcomes and the Short Falls Efficacy Scale-SFES after the intervention.,"['Older People', 'Thirty community-dwelling older women', 'older people']","['Kinect-based interactive fall intervention system', 'intervention group (IG) or a control group (CG', 'novel Kinect-based tailored interactive fall intervention system, which seamlessly integrates multifactorial fall risk assessment and tailored intervention programs', 'Novel Kinect-Based Tailored Interactive Fall Intervention System']","['SUS and CLS scores', 'TUG completion time', ""older people's physical and cognitive abilities"", 'average System Usability Scale (SUS) score', 'TUG and BBS', 'fear of falling', 'overall mean Computer Literacy Scale (CLS) score', 'static balance-related performance outcomes and the Short Falls Efficacy Scale-SFES', 'Montreal Cognitive Assessment-MoCA', 'BBS-Berg Balance Scale', 'TUG-Timed Up and Go']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1532976', 'cui_str': 'Fall risk assessment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0574518', 'cui_str': 'Susu language'}, {'cui': 'C0006790', 'cui_str': 'Calusterone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009603', 'cui_str': 'Computer Literacy'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1870204', 'cui_str': '(18F)1-(2-fluoroethyl)-4-((4-cyanophenoxy)methyl)piperidine'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",100.0,0.0106983,There were no significant changes in static balance-related performance outcomes and the Short Falls Efficacy Scale-SFES after the intervention.,"[{'ForeName': 'Taekyoung', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Industrial and Systems Engineering, College of Engineering, Korea Advanced Institute of Science and Technology (KAIST), Daejeon, South Korea.'}, {'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Xiong', 'Affiliation': 'Department of Industrial and Systems Engineering, College of Engineering, Korea Advanced Institute of Science and Technology (KAIST), Daejeon, South Korea.'}]",Frontiers in public health,['10.3389/fpubh.2022.884551']
2380,35712532,High-Definition Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex Modulates the Electroencephalography Rhythmic Activity of Parietal Occipital Lobe in Patients With Chronic Disorders of Consciousness.,"Background


Disorders of consciousness (DOC) are a spectrum of pathologies affecting one's ability to interact with the external world. At present, High-Definition Transcranial Direct Current Stimulation (HD-tDCS) is used in many patients with DOC as a non-invasive treatment, but electrophysiological research on the effect of HD-tDCS on patients with DOC is limited.
Objectives


To explore how HD-tDCS affects the cerebral cortex and examine the possible electrophysiological mechanisms underlying the effects of HD-tDCS on the cerebral cortex.
Methods


A total of 19 DOC patients were assigned to HD-tDCS stimulation. Each of them underwent 10 anodal HD-tDCS sessions of the left dorsolateral prefrontal cortex (DLPFC) over 5 consecutive days. Coma Recovery Scale-Revision (CRS-R) scores were recorded to evaluate the consciousness level before and after HD-tDCS, while resting-state electroencephalography (EEG) recordings were obtained immediately before and after single and multiple HD-tDCS stimuli. Depending on whether the CRS-R score increased after stimulation, we classified the subjects into responsive (RE) and non-responsive (N-RE) groups and compared the differences in power spectral density (PSD) between the groups in different frequency bands and brain regions, and also examined the relationship between PSD values and CRS-R scores.
Results


For the RE group, the PSD value of the parieto-occipital region increased significantly in the 6-8 Hz frequency band after multiple stimulations by HD-tDCS. After a single stimulation, an increase in PSD was observed at 10-13 and 13-30 Hz. In addition, for all subjects, a positive correlation was observed between the change in PSD value in the parieto-occipital region at 10-13 and 6-8 Hz frequency band and the change in CRS-R score after a single stimulation.
Conclusion


Repeated anodal HD-tDCS of the left DLPFC can improve clinical outcomes in patients with DOC, and HD-tDCS-related increased levels of consciousness were associated with increased parieto-occipital PSD.",2022,the PSD value of the parieto-occipital region increased significantly in the 6-8 Hz frequency band after multiple stimulations by HD-tDCS.,"['19 DOC patients', 'Patients With Chronic Disorders of Consciousness']","['10 anodal HD-tDCS sessions', 'High-Definition Transcranial Direct Current Stimulation', 'High-Definition Transcranial Direct Current Stimulation (HD-tDCS', 'HD-tDCS']","['CRS-R score', 'PSD values and CRS-R scores', 'Coma Recovery Scale-Revision (CRS-R) scores', 'PSD value of the parieto-occipital region', 'levels of consciousness', 'PSD', 'resting-state electroencephalography (EEG) recordings', 'power spectral density (PSD']","[{'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}, {'cui': 'C0234425', 'cui_str': 'Level of consciousness'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",19.0,0.0206418,the PSD value of the parieto-occipital region increased significantly in the 6-8 Hz frequency band after multiple stimulations by HD-tDCS.,"[{'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yajuan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2022.889023']
2381,35712521,Effectiveness of the Sanyin Formula Plus Chemotherapy on Survival in Women With Triple-Negative Breast Cancer: A Randomized Controlled Trial.,"Purpose


To evaluate the efficacy of the Sanyin formula (SYF) plus conventional standard chemotherapy in operable triple-negative breast cancer (TNBC) patients, a randomized controlled trial was implemented at 5 hospitals and cancer centers in China between May 23, 2016, and October 31, 2019.
Materials and Methods


Female patients aged 18 to 80 years with operable TNBC after definitive surgery were screened and enrolled. The exclusion criteria included metastatic disease, other tumors, or locally advanced disease. Patients were randomly divided into groups SYF plus conventional standard chemotherapy and placebo plus conventional standard chemotherapy at a ratio of 1:1. The primary endpoint of the investigation was disease-free survival (DFS), and secondary endpoints included overall survival (OS) and toxicity.
Results


A total of 252 operable female TNBC patients were randomized to receive SYF plus conventional standard chemotherapy (N = 127) or a placebo plus conventional standard chemotherapy (N = 125). At a median follow-up of 51 months, 5-year DFS time was longer in those assigned to SYF plus conventional standard chemotherapy compared with placebo plus conventional standard chemotherapy (94.2%vs 85.5%, hazard ratio [HR] = 0.40; 95%CI, 0.17-0.97;  P  = 0.034). The absolute benefit for 5-year DFS was 8.7% in the SYF plus conventional standard chemotherapy group. No statistically significant difference was observed in OS between the two groups ( P  = 0.23). Patients with negative node status benefited more from SYF plus conventional standard chemotherapy treatment (HR = 0.21,  P -interaction = 0.013) in accordance with the exploratory subgroup analyses of DFS.
Conclusions


The results of the present study suggest that the traditional Chinese medicine SYF plus conventional chemotherapy regimens is an effective alternative adjuvant chemotherapy strategy for female operable TNBC patients.
Clinical Trial Registration


https://www.chictr.org.cn/searchproj.aspx, identifier ChiCTR-IPR-16008590.",2022,"At a median follow-up of 51 months, 5-year DFS time was longer in those assigned to SYF plus conventional standard chemotherapy compared with placebo plus conventional standard chemotherapy (","['252 operable female TNBC patients', 'Women With Triple-Negative Breast Cancer', 'Female patients aged 18 to 80 years with operable TNBC after definitive surgery were screened and enrolled', 'operable triple-negative breast cancer (TNBC) patients', '5 hospitals and cancer centers in China between May 23, 2016, and October 31, 2019', 'female operable TNBC patients']","['Sanyin formula (SYF) plus conventional standard chemotherapy', 'placebo plus conventional standard chemotherapy ', 'Sanyin Formula Plus Chemotherapy', 'SYF plus conventional standard chemotherapy', 'placebo plus conventional standard chemotherapy', 'SYF plus conventional standard chemotherapy and placebo plus conventional standard chemotherapy']","['5-year DFS time', 'overall survival (OS) and toxicity', '5-year DFS', 'Survival', 'disease-free survival (DFS', 'OS']","[{'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",252.0,0.158278,"At a median follow-up of 51 months, 5-year DFS time was longer in those assigned to SYF plus conventional standard chemotherapy compared with placebo plus conventional standard chemotherapy (","[{'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Chenping', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Breast Surgery, Key Laboratory of Breast Cancer in Shanghai, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yuenong', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xueqing', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Breast, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery (Thyroid and Breast Surgery), Shanghai Traditional Chinese Medicine Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery (Thyroid and Breast Surgery), Shanghai Traditional Chinese Medicine Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wenchao', 'Initials': 'W', 'LastName': 'Qu', 'Affiliation': 'Department of Breast, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Department of Breast Surgery, Key Laboratory of Breast Cancer in Shanghai, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Frontiers in oncology,['10.3389/fonc.2022.850155']
2382,35712484,Radiomics Nomogram in Assisting Lymphadenectomy Decisions by Predicting Lymph Node Metastasis in Early-Stage Endometrial Cancer.,"Background


Lymph node metastasis (LNM) is an important risk factor affecting treatment strategy and prognosis for endometrial cancer (EC) patients. A radiomics nomogram was established in assisting lymphadenectomy decisions preoperatively by predicting LNM status in early-stage EC patients.
Methods


A total of 707 retrospective clinical early-stage EC patients were enrolled and randomly divided into a training cohort and a test cohort. Radiomics features were extracted from MR imaging. Three models were built, including a guideline-recommended clinical model (grade 1-2 endometrioid tumors by dilatation and curettage and less than 50% myometrial invasion on MRI without cervical infiltration), a radiomics model (selected radiomics features), and a radiomics nomogram model (combing the selected radiomics features, myometrial invasion on MRI, and cancer antigen 125). The predictive performance of the three models was assessed by the area under the receiver operating characteristic (ROC) curves (AUC). The clinical decision curves, net reclassification index (NRI), and total integrated discrimination index (IDI) based on the total included patients to assess the clinical benefit of the clinical model and the radiomics nomogram were calculated.
Results


The predictive ability of the clinical model, the radiomics model, and the radiomics nomogram between LNM and non-LNM were 0.66 [95% CI: 0.55-0.77], 0.82 [95% CI: 0.74-0.90], and 0.85 [95% CI: 0.77-0.93] in the training cohort, and 0.67 [95% CI: 0.56-0.78], 0.81 [95% CI: 0.72-0.90], and 0.83 [95% CI: 0.74-0.92] in the test cohort, respectively. The decision curve analysis, NRI (1.06 [95% CI: 0.81-1.32]), and IDI (0.05 [95% CI: 0.03-0.07]) demonstrated the clinical usefulness of the radiomics nomogram.
Conclusions


The predictive radiomics nomogram could be conveniently used for individualized prediction of LNM and assisting lymphadenectomy decisions in early-stage EC patients.",2022,"The decision curve analysis, NRI (1.06 [95% CI: 0.81-1.32]), and IDI (0.05 [95% CI: 0.03-0.07]) demonstrated the clinical usefulness of the radiomics nomogram.
","['707 retrospective clinical early-stage EC patients', 'endometrial cancer (EC) patients', 'Early-Stage Endometrial Cancer']",[],"['clinical decision curves, net reclassification index (NRI), and total integrated discrimination index (IDI', 'area under the receiver operating characteristic (ROC) curves (AUC']","[{'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",3.0,0.227031,"The decision curve analysis, NRI (1.06 [95% CI: 0.81-1.32]), and IDI (0.05 [95% CI: 0.03-0.07]) demonstrated the clinical usefulness of the radiomics nomogram.
","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Jinshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bi-Cong', 'Initials': 'BC', 'LastName': 'Yan', 'Affiliation': 'Department of Radiology, Jinshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Jinshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Feng-Hua', 'Initials': 'FH', 'LastName': 'Ma', 'Affiliation': 'Departments of Radiology, Obstetrics & Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jin-Wei', 'Initials': 'JW', 'LastName': 'Qiang', 'Affiliation': 'Department of Radiology, Jinshan Hospital, Fudan University, Shanghai, China.'}]",Frontiers in oncology,['10.3389/fonc.2022.894918']
2383,35712946,[Clinical observation on different frequency of auricular bloodletting combined with auricular point sticking for acne vulgaris].,"OBJECTIVE


To observe the clinical efficacy of different treatment frequency of auricular bloodletting combined with auricular point sticking for acne vulgaris.
METHODS


A total of 90 patients with acne vulgaris were randomized into a treatment group 1 (30 cases, 2 cases dropped off), a treatment group 2 (30 cases, 4 cases dropped off) and a treatment group 3 (30 cases, 5 cases dropped off). Combination therapy of auricular bloodletting and auricular point sticking at Fei (CO 14 ), Shenmen (TF 4 ), Neifenmi (CO 18 ) and Shenshangxian (TG 2 p) were given once a week, twice a week and 3 times a week in the treatment group 1, the treatment group 2 and the treatment group 3 respectively, 4 weeks were as one course and totally 3 courses were required in the 3 groups. Before treatment and after 1, 2, 3 courses of treatment, the scores of global acne grading system (GAGS), skin lesion and quality of life-acne (QoL-Acne) were observed, the clinical efficacy was evaluated after 3 courses of treatment and the recurrence rate was evaluated in follow-up of 1 month after treatment in the 3 groups.
RESULTS


Compared before treatment, the scores of GAGS and skin lesion were decreased at each time point in the 3 groups ( P <0.05), the QoL-Acne scores were increased after 1 course of treatment in the treatment group 3 and after 2, 3 courses of treatment in the 3 groups ( P <0.05). There were no statistical differences in scores of GAGS, skin lesion and QoL-Acne among the 3 groups ( P >0.05). There were no statistical differences in effective rate and recurrence rate among the 3 groups ( P >0.05).
CONCLUSION


Different frequency of auricular bloodletting combined with auricular point sticking have similar efficacy in treating acne vulgaris, all can improve the skin lesion and quality of life in patients with acne vulgaris, and have a cumulative effect and good long-term curative effect.",2022,"There were no statistical differences in scores of GAGS, skin lesion and QoL-Acne among the 3 groups ( P >0.05).","['90 patients with acne vulgaris', 'acne vulgaris', 'patients with acne vulgaris']","['auricular bloodletting combined with auricular point sticking', 'auricular bloodletting and auricular point sticking at Fei (CO 14 ), Shenmen (TF 4 ), Neifenmi (CO 18 ) and Shenshangxian']","['scores of GAGS, skin lesion and QoL-Acne', 'effective rate and recurrence rate', 'recurrence rate', 'clinical efficacy', 'scores of GAGS and skin lesion', 'scores of global acne grading system (GAGS), skin lesion and quality of life-acne (QoL-Acne', 'QoL-Acne scores', 'skin lesion and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1706582', 'cui_str': 'Stick'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",90.0,0.0177252,"There were no statistical differences in scores of GAGS, skin lesion and QoL-Acne among the 3 groups ( P >0.05).","[{'ForeName': 'Ya-Yu', 'Initials': 'YY', 'LastName': 'Gao', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Yan-Fen', 'Initials': 'YF', 'LastName': 'She', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China; International Joint Research Center for Advantageous Diseases of Acupuncture and Moxibustion in Hebei Province, Shijiazhuang 050200.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Xiao-Dan', 'Initials': 'XD', 'LastName': 'Song', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Ming-Jian', 'Initials': 'MJ', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Xi-Sheng', 'Initials': 'XS', 'LastName': 'Fan', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China.'}, {'ForeName': 'Jun-Cha', 'Initials': 'JC', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China; International Joint Research Center for Advantageous Diseases of Acupuncture and Moxibustion in Hebei Province, Shijiazhuang 050200.'}, {'ForeName': 'Xu-Liang', 'Initials': 'XL', 'LastName': 'Shi', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei University of CM, Shijiazhuang 050200, China; International Joint Research Center for Advantageous Diseases of Acupuncture and Moxibustion in Hebei Province, Shijiazhuang 050200.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20210519-k0006']
2384,35712800,"Bromocriptine Quick-Release as Adjunct Therapy in Youth and Adults with Type 1 Diabetes: A Randomized, Placebo-Controlled Crossover Study.","AIM


To evaluate the potential for glycemic, renal, and vascular benefits of Bromocriptine Quick Release (BCQR) in youth and adults with type 1 diabetes.
MATERIALS AND METHODS


Forty adolescents and forty adults with type 1 diabetes ages 12-60 years were enrolled in a double-blind, placebo-controlled, random order crossover study of 4 weeks of treatment in the morning with BCQR (titrated weekly from 0.8 mg to 1.6 mg to 3.2 mg, minimum dose 1.6 mg). Study assessments after each phase included blood pressure (BP), lipids, peripheral arterial stiffness and autonomic function, mixed meal tolerance test (MMTT), continuous glucose monitoring (CGM), creatinine, estimated glomerular filtration rate (eGFR), estimated insulin sensitivity (eIS), insulin dose, and indirect calorimetry.
RESULTS


Adolescents displayed baseline hyperglycemia, insulin resistance, metabolic dysfunction, and increased renal filtration compared to adults. In both age groups, CGM measures, eIS and insulin dose did not differ with BCQR treatment. In adolescents, BCQR decreased systolic BP, diastolic BP and triangular index and increased serum creatinine. In adults, systolic BP, mean arterial pressure (MAP), systemic vascular resistance, and MMTT glucose and glucagon-like peptide 1 AUC's were lower, and orthostatic drop in systolic BP was greater with BCQR.
CONCLUSIONS


Greater hyperglycemia, insulin resistance, metabolic dysfunction and renal hyperfiltration in adolescents argues for increased attention during this high-risk age period. Though BCQR had little impact on glycemia or insulin sensitivity, initial vascular and renal responses suggest potential benefits of BCQR in youth and adults with type 1 diabetes requiring further study. This article is protected by copyright. All rights reserved.",2022,"In both age groups, CGM measures, eIS and insulin dose did not differ with BCQR treatment.","['youth and adults with type 1 diabetes requiring further study', 'youth and adults with type 1 diabetes', 'Youth and Adults with Type 1 Diabetes', 'Forty adolescents and forty adults with type 1 diabetes ages 12-60\u2009years']","['Bromocriptine Quick-Release', 'BCQR', 'Bromocriptine Quick Release (BCQR', 'placebo', 'Placebo']","['systolic BP, diastolic BP and triangular index and increased serum creatinine', 'hyperglycemia, insulin resistance, metabolic dysfunction and renal hyperfiltration', 'blood pressure (BP), lipids, peripheral arterial stiffness and autonomic function, mixed meal tolerance test (MMTT), continuous glucose monitoring (CGM), creatinine, estimated glomerular filtration rate (eGFR), estimated insulin sensitivity (eIS), insulin dose, and indirect calorimetry', 'baseline hyperglycemia, insulin resistance, metabolic dysfunction, and increased renal filtration', 'glycemia or insulin sensitivity, initial vascular and renal responses', 'orthostatic drop in systolic BP', 'systolic BP, mean arterial pressure (MAP), systemic vascular resistance, and MMTT glucose and glucagon-like peptide']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006230', 'cui_str': 'Bromocriptine'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0700225', 'cui_str': 'Serum creatinine raised'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0014361', 'cui_str': 'Glucagon-Like Polypeptides'}]",40.0,0.1109,"In both age groups, CGM measures, eIS and insulin dose did not differ with BCQR treatment.","[{'ForeName': 'Shoshana S', 'Initials': 'SS', 'LastName': 'Tell', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Schafer', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Vigers', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Baumgartner', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Lyon', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gross', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Polsky', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Snell-Bergeon', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Irene E', 'Initials': 'IE', 'LastName': 'Schauer', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14800']
2385,35712743,Ottawa Decision Support Framework to Improve Iranian Nurses' Decision Coaching Skills.,"Introduction


Nurses play an important role in providing decision coaching (DC) and developing informed decision-making in families of patients hospitalized in intensive care units (ICUs). Therefore, taking necessary measures to develop nurses' DC skills is essential. The present study was conducted to analyze the application of the Ottawa Decision Support Framework (ODSF) in developing Iranian nurses' DC skills.
Methodology


In this experimental pretest-posttest study, two hospitals (Imam Reza and Shahid Kamyab hospitals) in the city of Mashhad were randomly placed in either the experimental or the control group. Based on a simple random sampling method, 60 ICU nurses were selected. For nurses in the experimental group, a 2-day workshop was conducted based on the ODSF, whereas nurses in the control group received no intervention. Using the SPSS-16 software and statistical tests of paired-samples  t -test, independent-samples  t -test, and Chi-square test ( p  <0.05), the data were analyzed.
Results


Before the intervention, no difference was observed in the mean DC scores obtained by the nurses in the experimental and control groups ( p  = 0.891). However, after the intervention, a significant difference was observed in the mean DC scores obtained by the nurses in the experimental and control groups ( p  <0.001).
Conclusion


The results indicated that applying the ODSF is effective in improving Iranian nurses' DC skills. It was also indicated that the concepts presented in this framework are consistent with Iranian nurses' cultural backgrounds. Accordingly, the application of the ODSF is offered in Iranian nurses' continuing education programs to improve their DC skills.
How to cite this article


Moghadam ES, Manzari ZS, Ghalenow HR, Sanchooli HN. Ottawa Decision Support Framework to Improve Iranian Nurses' Decision Coaching Skills. Indian J Crit Care Med 2022;26(2):199-203.",2022,", no difference was observed in the mean DC scores obtained by the nurses in the experimental and control groups ( p  = 0.891).","['two hospitals (Imam Reza and Shahid Kamyab hospitals) in the city of Mashhad', 'families of patients hospitalized in intensive care units (ICUs', '60 ICU nurses were selected']","['Ottawa Decision Support Framework (ODSF', 'ODSF']",['mean DC scores'],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0223174,", no difference was observed in the mean DC scores obtained by the nurses in the experimental and control groups ( p  = 0.891).","[{'ForeName': 'Elham Shahraki', 'Initials': 'ES', 'LastName': 'Moghadam', 'Affiliation': 'School of Nursing and Midwifery, Zabol University of Medical Sciences, Zabol, Iran.'}, {'ForeName': 'Zahra Sadat', 'Initials': 'ZS', 'LastName': 'Manzari', 'Affiliation': 'Department of Internal Surgery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hossein Rashki', 'Initials': 'HR', 'LastName': 'Ghalenow', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Hajar Noori', 'Initials': 'HN', 'LastName': 'Sanchooli', 'Affiliation': 'School of Nursing and Midwifery, Zahedan University of Medical Sciences, Zahedan, Iran.'}]","Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine",['10.5005/jp-journals-10071-24106']
2386,35712723,Cost-Effectiveness of Pembrolizumab Plus Chemotherapy as First-Line Therapy for Advanced Oesophageal Cancer.,"Objective:  Pembrolizumab plus chemotherapy is recommended as the first-line treatment for advanced oesophageal cancer. The objective of this study is to evaluate the cost-effectiveness of pembrolizumab plus chemotherapy as first-line therapy for advanced oesophageal cancer from the healthcare system perspective in China.  Methods:  Based on the KEYNOTE-590 trial, a Markov model was constructed to estimate the cost and effectiveness of pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively. Total costs, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. One-way, probabilistic sensitivity analyses (PSA), and subgroup analyses were adapted to test the model robustness.  Result:  Compared with the placebo group, pembrolizumab group obtained an additional 1.05 QALY, but the cost was also increased by $121,478.76. The ICER was $115,391.84 per QALY gained, which was higher than the willingness-to-pay (WTP) of $31,304.31. The results of One-way sensitivity analyses showed that the ICER was sensitive to the hazard ratio of PFS and per cycle cost of pembrolizumab. At a WTP threshold of $31,304.31, the probability of pembrolizumab plus chemotherapy being cost-effective was 0%.  Conclusion:  From the perspective of China healthcare system, pembrolizumab plus chemotherapy as first-line treatment is not cost-effective for patients with advanced oesophageal cancer compared with placebo plus chemotherapy.",2022,"The ICER was $115,391.84 per QALY gained, which was higher than the willingness-to-pay (WTP) of $31,304.31.","['advanced oesophageal cancer', 'advanced oesophageal cancer from the healthcare system perspective in China', 'Advanced Oesophageal Cancer', 'patients with advanced oesophageal cancer']","['pembrolizumab', 'Pembrolizumab Plus Chemotherapy', 'pembrolizumab plus chemotherapy and placebo plus chemotherapy', 'placebo plus chemotherapy', 'Pembrolizumab plus chemotherapy', 'pembrolizumab plus chemotherapy', 'placebo']","['ICER', 'Total costs, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'hazard ratio of PFS and per cycle cost of pembrolizumab']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]",,0.105768,"The ICER was $115,391.84 per QALY gained, which was higher than the willingness-to-pay (WTP) of $31,304.31.","[{'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Shuxia', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chongqing', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'PET Imaging Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Lidan', 'Initials': 'L', 'LastName': 'Yi', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2022.881787']
2387,35713160,Effect of vitamin C on immune reconstitution after bone marrow transplantation.,"BACKGROUND


Vitamin C is an essential nutrient for the adequate function and maturation of the immune system. In vitro studies show that the development, proliferation, and functioning of T cells requires vitamin C, especially for natural killer (NK) cells. Their deficiency during the acute phase post-transplantation could cause greater morbidity and mortality in these patients. A prospective clinical trial using high-dose vitamin C was performed to determine if vitamin C supplementation improves reconstitution of NK lymphocytes after hematopoietic stem cell transplantation (HSCT).
MATERIALS AND METHODS


We enrolled 24 patients who underwent autologous HSCT for multiple myeloma and lymphoma. Patients were randomized to receive standard treatment or standard treatment plus 20 g vitamin C once daily (1 - 10 days) and 500 mg twice daily (11 - 100 days) after transplantation.
RESULTS


NK and CD3+ lymphocytes showed an increase from days +30 to +100 only in the vitamin C-treated group. Patients in the vitamin C group had a lower frequency of infections. No severe adverse events were reported.
CONCLUSION


Our results suggest that high-dose vitamin C supplementation is an effective and safe therapeutic option to decrease the frequency of infections and enhance immune reconstitution after HSCT.",2022,"RESULTS


NK and CD3+ lymphocytes showed an increase from days +30 to +100 only in the vitamin C-treated group.","['We enrolled 24 patients who underwent', 'after bone marrow transplantation', 'NK lymphocytes after hematopoietic stem cell transplantation (HSCT', 'for multiple myeloma and lymphoma']","['vitamin C supplementation', 'autologous HSCT', 'standard treatment or standard treatment plus 20\xa0g vitamin C', 'vitamin C']","['severe adverse events', 'morbidity and mortality', 'frequency of infections', 'immune reconstitution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}]","[{'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}]",24.0,0.13696,"RESULTS


NK and CD3+ lymphocytes showed an increase from days +30 to +100 only in the vitamin C-treated group.","[{'ForeName': 'Victor Itaí', 'Initials': 'VI', 'LastName': 'Urbalejo-Ceniceros', 'Affiliation': ''}, {'ForeName': 'Héctor Isaac', 'Initials': 'HI', 'LastName': 'Rocha-González', 'Affiliation': ''}, {'ForeName': 'Brenda Lizeth', 'Initials': 'BL', 'LastName': 'Acosta-Maldonado', 'Affiliation': ''}, {'ForeName': 'Luis Manuel', 'Initials': 'LM', 'LastName': 'Valero-Saldaña', 'Affiliation': ''}, {'ForeName': 'Areli Eunice', 'Initials': 'AE', 'LastName': 'Hernández-Alcantara', 'Affiliation': ''}, {'ForeName': 'Dana Aline', 'Initials': 'DA', 'LastName': 'Pérez-Camargo', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP204182']
2388,35713119,Comparison between radial and focused types of extracorporeal shock-wave therapy in plantar calcaneal spur: A randomised sham-controlled trial.,"OBJECTIVES


Both radial and focused types of extracorporeal shock wave therapy (ESWT) have been used in patients with plantar calcaneal spur (PCS). However, no study has yet addressed the comparative effects of these treatments on the condition. Considering radial and focused waves are different from each other, their effectiveness may also be different in clinical practice. The aim of this study was to compare the effects of radial and focused types of ESWT on PCS.
METHODS


Ninety nine patients with plantar calcaneal spur were randomised into three groups according to ESWT types: focused, radial, and sham. ESWT was applied as 3 sessions, with 2-4 days intervals (excluding weekends). All patients were evaluated at baseline (week 0) and weeks 1, 5, and 13. The Foot Function Index (FFI) scores were used as outcome measures.
RESULTS


Compared with baseline (week 0), at the end of treatment (week 1) and at the follow-up periods (weeks 5, and 13) the FFI scores were significantly reduced in both focused and radial ESWT groups (for all, p<0.001). When considering the change in data from baseline to follow-up periods (weeks 5, and 13), both focused and radial ESWT groups were significantly superior than the sham group in the all outcome measures (for all, p<0.05). Importantly, radial group was significantly superior than focused group based on the changes in the FFI scores (for all, p<0.05).
CONCLUSION


Both focused ESWT and radial ESWT are effective in plantar calcaneal spur. When considering the degree and continuity of the positive effects, radial ESWT is superior than focused ESWT in plantar calcaneal spur.",2022,"Importantly, radial group was significantly superior than focused group based on the changes in the FFI scores (for all, p<0.05).
","['Ninety nine patients with plantar calcaneal spur', 'plantar calcaneal spur', 'patients with plantar calcaneal spur (PCS']","['extracorporeal shock wave therapy (ESWT', 'ESWT and radial ESWT', 'extracorporeal shock-wave therapy', 'ESWT']","['Foot Function Index (FFI) scores', 'FFI scores']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0158322', 'cui_str': 'Calcaneal spur'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0442038', 'cui_str': 'Radial'}]","[{'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",99.0,0.0295823,"Importantly, radial group was significantly superior than focused group based on the changes in the FFI scores (for all, p<0.05).
","[{'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Şah', 'Affiliation': 'Department of Sports Medicine, Yuzuncu Yil University Hospital, Van, Turkey.'}, {'ForeName': 'Şeyhmus', 'Initials': 'Ş', 'LastName': 'Kaplan', 'Affiliation': 'Department of Sports Medicine, Yuzuncu Yil University Hospital, Van, Turkey.'}, {'ForeName': 'Sezai', 'Initials': 'S', 'LastName': 'Özkan', 'Affiliation': 'Department of Orthopedics and Traumatology, Yuzuncu Yil University Hospital, Van, Turkey.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Adanaş', 'Affiliation': 'Department of Orthopedics and Traumatology, Yuzuncu Yil University Hospital, Van, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Toprak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Yuzuncu Yil University Hospital, Van, Turkey.'}]",The Physician and sportsmedicine,['10.1080/00913847.2022.2091413']
2389,35709019,Restriction of Intravenous Fluid in ICU Patients with Septic Shock.,"BACKGROUND


Intravenous fluids are recommended for the treatment of patients who are in septic shock, but higher fluid volumes have been associated with harm in patients who are in the intensive care unit (ICU).
METHODS


In this international, randomized trial, we assigned patients with septic shock in the ICU who had received at least 1 liter of intravenous fluid to receive restricted intravenous fluid or standard intravenous fluid therapy; patients were included if the onset of shock had been within 12 hours before screening. The primary outcome was death from any cause within 90 days after randomization.
RESULTS


We enrolled 1554 patients; 770 were assigned to the restrictive-fluid group and 784 to the standard-fluid group. Primary outcome data were available for 1545 patients (99.4%). In the ICU, the restrictive-fluid group received a median of 1798 ml of intravenous fluid (interquartile range, 500 to 4366); the standard-fluid group received a median of 3811 ml (interquartile range, 1861 to 6762). At 90 days, death had occurred in 323 of 764 patients (42.3%) in the restrictive-fluid group, as compared with 329 of 781 patients (42.1%) in the standard-fluid group (adjusted absolute difference, 0.1 percentage points; 95% confidence interval [CI], -4.7 to 4.9; P = 0.96). In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, -1.7 percentage points; 99% CI, -7.7 to 4.3). At 90 days after randomization, the numbers of days alive without life support and days alive and out of the hospital were similar in the two groups.
CONCLUSIONS


Among adult patients with septic shock in the ICU, intravenous fluid restriction did not result in fewer deaths at 90 days than standard intravenous fluid therapy. (Funded by the Novo Nordisk Foundation and others; CLASSIC ClinicalTrials.gov number, NCT03668236.).",2022,"In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, -1.7 percentage points; 99% CI, -7.7 to 4.3).","['patients with septic shock in the ICU who had received at least 1 liter of intravenous fluid to receive restricted intravenous fluid or standard intravenous fluid therapy; patients were included if the onset of shock had been within 12 hours before screening', 'ICU Patients with Septic Shock', 'patients who are in the intensive care unit (ICU', 'adult patients with septic shock in the ICU', 'patients who are in septic shock', 'We enrolled 1554 patients; 770 were assigned to the restrictive-fluid group and 784 to the standard-fluid group']",[],"['serious adverse events', 'death from any cause within 90 days after randomization', 'deaths', 'death', 'numbers of days alive without life support and days alive and out of the hospital']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",1554.0,0.517053,"In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, -1.7 percentage points; 99% CI, -7.7 to 4.3).","[{'ForeName': 'Tine S', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Hjortrup', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Praleene', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Jon H', 'Initials': 'JH', 'LastName': 'Laake', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cecconi', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Nalos', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Malbrain', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Maj-Brit N', 'Initials': 'MN', 'LastName': 'Kjær', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Overgaard-Steensen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Björn A', 'Initials': 'BA', 'LastName': 'Brand', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Winther-Olesen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Jonathan O', 'Initials': 'JO', 'LastName': 'White', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Quist', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Westergaard', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Andreas B', 'Initials': 'AB', 'LastName': 'Jonsson', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Carl J S', 'Initials': 'CJS', 'LastName': 'Hjortsø', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Meier', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Janus', 'Initials': 'J', 'LastName': 'Engstrøm', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nebrich', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Nina C', 'Initials': 'NC', 'LastName': 'Andersen-Ranberg', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Jacob V', 'Initials': 'JV', 'LastName': 'Jensen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Neeliya A', 'Initials': 'NA', 'LastName': 'Joseph', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Lone M', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Louise S', 'Initials': 'LS', 'LastName': 'Herløv', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Christoffer G', 'Initials': 'CG', 'LastName': 'Sølling', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Pedersen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Kurt K', 'Initials': 'KK', 'LastName': 'Knudsen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Therese S', 'Initials': 'TS', 'LastName': 'Straarup', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Marianne L', 'Initials': 'ML', 'LastName': 'Vang', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Bodil S', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Søren R', 'Initials': 'SR', 'LastName': 'Aagaard', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Russell', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schønemann-Lund', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Claes F', 'Initials': 'CF', 'LastName': 'Elvander', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Søren K L', 'Initials': 'SKL', 'LastName': 'Hoffmann', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Rasmussen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Yvonne K', 'Initials': 'YK', 'LastName': 'Martin', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Fredrik F', 'Initials': 'FF', 'LastName': 'Friberg', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Seter', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Tayyba N', 'Initials': 'TN', 'LastName': 'Aslam', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Ådnøy', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Seidel', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Strand', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Bror', 'Initials': 'B', 'LastName': 'Johnstad', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Joelsson-Alm', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Christensen', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ahlstedt', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Pfortmueller', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Greco', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Raděj', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Kříž', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Doug W', 'Initials': 'DW', 'LastName': 'Gould', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Kathy M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': ""From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2202707']
2390,35708992,"The Effect of Solution Focused Group Psychoeducation Applied to Schizophrenia Patients on Self-Esteem, Perception of Subjective Recovery and Internalized Stigmatization.","The study examined the effect of Solution-Focused Group Psychoeducation on self-esteem, subjective perception of recovery, and internalized stigma among patients with schizophrenia 39 patients with schizophrenia were recruited based design of the randomized control-group with pretest and posttest. The patients completed the ""Rosenberg Self-Esteem Scale (RSES)"", ""Subjective Recovery Assessment Scale (SubRAS)"", and ""Internalized Stigma of Mental Illness (ISMI) Scale"" in pretest and posttest. After the psychoeducation, ISMI scores decreased in the intervention group ( p  < 0.001) but increased in the control group ( p  = 0.599). The posttest RSES score was lower in the intervention group compared to the control group ( p  = 0.001). A statistically significant difference was found between the pretest and posttest SRAS scores of the intervention group when compared to the control group ( p  = 0.018). After the psychoeducation, intervention group' self-esteem and subjective perception of recovery increased, while the severity of internalized stigma decreased.",2022,The posttest RSES score was lower in the intervention group compared to the control group ( p  = 0.001).,['patients with schizophrenia 39 patients with schizophrenia'],['Solution-Focused Group Psychoeducation'],"['Rosenberg Self-Esteem Scale (RSES)"", ""Subjective Recovery Assessment Scale (SubRAS)"", and ""Internalized Stigma of Mental Illness (ISMI) Scale', 'posttest RSES score', 'ISMI scores', 'pretest and posttest SRAS scores', 'Self-Esteem, Perception of Subjective Recovery and Internalized Stigmatization', 'self-esteem, subjective perception of recovery, and internalized stigma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038330', 'cui_str': 'Stigmatization'}]",39.0,0.00998854,The posttest RSES score was lower in the intervention group compared to the control group ( p  = 0.001).,"[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Erdoğan', 'Affiliation': 'Mental Health and Diseases Hospital, Samsun, Turkey.'}, {'ForeName': 'Satı', 'Initials': 'S', 'LastName': 'Demir', 'Affiliation': 'Faculty of Health Sciences Nursing Deparment, Gazi University, Ankara, Turkey.'}]",Issues in mental health nursing,['10.1080/01612840.2022.2083735']
2391,35708951,Gratitude expressions improve teammates' cardiovascular stress responses.,"Gratitude expressions play a key role in strengthening relationships, suggesting gratitude might promote adaptive responses during teamwork. However, little research has examined gratitude's impact on loose tie relationships (like coworkers), and similarly little research has examined how gratitude impacts physiological stress responding or biological responses more generally. The present research uses an ecologically valid, dyadic teamwork paradigm to test how gratitude expressions impact in vivo physiological challenge and threat stress responding, assessed via a challenge-threat index composed of cardiac output and total peripheral resistance. Compared with a control condition, teammates ( n  = 190) who were randomly assigned to a gratitude expression manipulation showed improved biological challenge-threat responses while jointly completing an acutely stressful collaborative work task (developing a product pitch), and later while completing an individual performance task (pitching the product). During the collaborative task, gratitude expressions buffered against threat responses; during the individual task, gratitude expressions amplified challenge responses. Analyses of cardiac output (CO) and total peripheral resistance (TPR) aided in determining how cardiac outflow versus vascular constriction/dilation contributed to these effects. The finding that gratitude expressions promote adaptive biological responding at the dyadic level contributes to a growing literature on the social functions of positive emotions and gratitude, specifically. The present results also have wider implications for physiological stress in performance tasks and suggest that workplace gratitude interventions can promote adaptive stress responding in teams. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"Compared with a control condition, teammates ( n  = 190) who were randomly assigned to a gratitude expression manipulation showed improved biological challenge-threat responses while jointly completing an acutely stressful collaborative work task (developing a product pitch), and later while completing an individual performance task (pitching the product).",[],"['gratitude expression manipulation showed improved biological challenge-threat responses while jointly completing an acutely stressful collaborative work task (developing a product pitch), and later while completing an individual performance task (pitching the product']","['cardiac output (CO) and total peripheral resistance (TPR', ""Gratitude expressions improve teammates' cardiovascular stress responses""]",[],"[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C1098484', 'cui_str': 'TPR protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.044301,"Compared with a control condition, teammates ( n  = 190) who were randomly assigned to a gratitude expression manipulation showed improved biological challenge-threat responses while jointly completing an acutely stressful collaborative work task (developing a product pitch), and later while completing an individual performance task (pitching the product).","[{'ForeName': 'Yumeng', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Rady School of Management.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Ocampo', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Algoe', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oveis', 'Affiliation': 'Rady School of Management.'}]",Journal of experimental psychology. General,['10.1037/xge0001238']
2392,35708946,I know you so I will regulate you: Closeness but not target's emotion type affects all stages of extrinsic emotion regulation.,"The Extended Process model of Emotion Regulation outlines the processes people use to influence the timing and type of emotions they have. The current study applies this model to extrinsic regulation (regulating others' emotions). In a 2x2 between-subjects design, we examine how the target person's emotion (anger/anxiety), and target/regulator closeness (close/distant) interact to predict the regulator's intention to regulate, regulation process choice, evaluation of regulation success (regulation self-efficacy), and empathy toward the target. Participants ( N  = 266) were randomly allocated to 1 of 4 conditions to read 3 vignettes where a close/distant target expressed anger/anxiety. Compared to distant targets, close targets elicited significantly greater intention to regulate, social sharing (but not humor, reappraisal, or distancing), self-efficacy of implementation and empathy. There was no support for emotion type or emotion-by-closeness hypotheses. We conclude that closeness but not emotion type affects emotion regulation at all 3 stages of the Extended Process model of Emotion Regulation. Future research could include the effect of closeness on additional processes (such as direct situation modification, or giving space). (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"Compared to distant targets, close targets elicited significantly greater intention to regulate, social sharing (but not humor, reappraisal, or distancing), self-efficacy of implementation and empathy.",['Participants ( N  = 266'],[],"['intention to regulate, social sharing (but not humor, reappraisal, or distancing), self-efficacy of implementation and empathy', 'emotion regulation', 'emotion type or emotion']",[],[],"[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0020168', 'cui_str': 'Humor'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",266.0,0.0344777,"Compared to distant targets, close targets elicited significantly greater intention to regulate, social sharing (but not humor, reappraisal, or distancing), self-efficacy of implementation and empathy.","[{'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Tanna', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'MacCann', 'Affiliation': 'School of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0001073']
2393,35712450,Molecular Signatures of Response to Mecasermin in Children With Rett Syndrome.,"Rett syndrome (RTT) is a devastating neurodevelopmental disorder without effective treatments. Attempts at developing targetted therapies have been relatively unsuccessful, at least in part, because the genotypical and phenotypical variability of the disorder. Therefore, identification of biomarkers of response and patients' stratification are high priorities. Administration of Insulin-like Growth Factor 1 (IGF-1) and related compounds leads to significant reversal of RTT-like symptoms in preclinical mouse models. However, improvements in corresponding clinical trials have not been consistent. A 20-weeks phase I open label trial of mecasermin (recombinant human IGF-1) in children with RTT demonstrated significant improvements in breathing phenotypes. However, a subsequent randomised controlled phase II trial did not show significant improvements in primary outcomes although two secondary clinical endpoints showed positive changes. To identify molecular biomarkers of response and surrogate endpoints, we used RNA sequencing to measure differential gene expression in whole blood samples of participants in the abovementioned phase I mecasermin trial. When all participants ( n  = 9) were analysed, gene expression was unchanged during the study (baseline vs. end of treatment, T0-T3). However, when participants were subclassified in terms of breathing phenotype improvement, specifically by their plethysmography-based apnoea index, individuals with moderate-severe apnoea and breathing improvement (Responder group) displayed significantly different transcript profiles compared to the other participants in the study (Mecasermin Study Reference group, MSR). Many of the differentially expressed genes are involved in the regulation of cell cycle processes and immune responses, as well as in IGF-1 signalling and breathing regulation. While the Responder group showed limited gene expression changes in response to mecasermin, the MSR group displayed marked differences in the expression of genes associated with inflammatory processes (e.g., neutrophil activation, complement activation) throughout the trial. Our analyses revealed gene expression profiles associated with severe breathing phenotype and its improvement after mecasermin administration in RTT, and suggest that inflammatory/immune pathways and IGF-1 signalling contribute to treatment response. Overall, these data support the notion that transcript profiles have potential as biomarkers of response to IGF-1 and related compounds.",2022,Administration of Insulin-like Growth Factor 1 (IGF-1) and related compounds leads to significant reversal of RTT-like symptoms in preclinical mouse models.,"['children with RTT', 'Children With Rett Syndrome']","['Insulin-like Growth Factor 1 (IGF-1', 'mecasermin (recombinant human IGF-1']","['breathing phenotype improvement, specifically by their plethysmography-based apnoea index, individuals with moderate-severe apnoea and breathing improvement', 'breathing phenotypes', 'gene expression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035372', 'cui_str': ""Rett's disorder""}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0904505', 'cui_str': 'mecasermin'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",9.0,0.092898,Administration of Insulin-like Growth Factor 1 (IGF-1) and related compounds leads to significant reversal of RTT-like symptoms in preclinical mouse models.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Shovlin', 'Affiliation': 'Neuropsychiatric Genetics, Trinity Center for Health Sciences, Trinity Translational Medicine Institute, St James Hospital, Dublin, Ireland.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Delepine', 'Affiliation': 'Department of Brain and Cognitive Sciences, Simons Center for the Social Brain, Picower Institute for Learning and Memory, MIT, Cambridge, MA, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Swanson', 'Affiliation': ""Department of Neurology, Rosamund Stone Zander Translational Neuroscience Center, Boston Children's Hospital and Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Snow', 'Initials': 'S', 'LastName': 'Bach', 'Affiliation': 'Neuropsychiatric Genetics, Trinity Center for Health Sciences, Trinity Translational Medicine Institute, St James Hospital, Dublin, Ireland.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Sahin', 'Affiliation': ""Department of Neurology, Rosamund Stone Zander Translational Neuroscience Center, Boston Children's Hospital and Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Mriganka', 'Initials': 'M', 'LastName': 'Sur', 'Affiliation': 'Department of Brain and Cognitive Sciences, Simons Center for the Social Brain, Picower Institute for Learning and Memory, MIT, Cambridge, MA, United States.'}, {'ForeName': 'Walter E', 'Initials': 'WE', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Human Genetics, Emory University School of Medicine, Atlanta, GA, United States.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tropea', 'Affiliation': 'Neuropsychiatric Genetics, Trinity Center for Health Sciences, Trinity Translational Medicine Institute, St James Hospital, Dublin, Ireland.'}]",Frontiers in neuroscience,['10.3389/fnins.2022.868008']
2394,35712448,Home-Based EEG Neurofeedback Intervention for the Management of Chronic Pain.,"Background


Chronic pain and associated symptoms often cause significant disability and reduced quality of life (QoL). Neurofeedback (NFB) as part of a Brain Computer Interface can help some patients manage chronic pain by normalising maladaptive brain activity measured with electroencephalography (EEG).
Objectives


This study was designed to assess the efficacy and safety of a novel home-based NFB device for managing chronic pain by modifying specific EEG activity.
Methods


A prospective, single-arm, proof-of-concept study was conducted between June 2020 and March 2021 among adults with chronic pain (registered with ClinicalTrials.gov NCT04418362). Axon EEG NFB systems for home use were provided to each, and 32-48 NFB training sessions were completed by the participants over 8-weeks. The primary outcome was self-reported pain. Assessment of central sensitisation, sleep quality, affective symptoms, change in QoL, adverse events during use and EEG correlations with symptoms were secondary outcomes.
Results


Sixteen participants were enrolled. Eleven reported pain relief following NFB training, eight reporting clinically significant improvements. Central sensitisation symptoms improved by a third ( p  < 0.0001), sleep quality by almost 50% ( p  < 0.001), anxiety reduced by 40% ( p  = 0.015), and QoL improved at final follow-up for 13 participants. The majority (69%) of participants who upregulated relative alpha reported improved pain, and those who downregulated relative hi-beta reported improved pain, reduced anxiety and depression scores. There were no adverse events during the trial.
Conclusions


Home-based NFB training is well-tolerated and may provide relief for sufferers of chronic pain and its associated symptoms.
Summary


Axon , a home-based NFB training device, can positively influence pain and associated symptoms in a proportion of people with chronic pain.",2022,"Central sensitisation symptoms improved by a third ( p  < 0.0001), sleep quality by almost 50% ( p  < 0.001), anxiety reduced by 40% ( p  = 0.015), and QoL improved at final follow-up for 13 participants.","['June 2020 and March 2021 among adults with chronic pain (registered with ClinicalTrials.gov NCT04418362', 'Sixteen participants were enrolled']","['Home-Based EEG Neurofeedback Intervention', 'NFB training', 'novel home-based NFB device', 'Neurofeedback (NFB']","['adverse events', 'Central sensitisation symptoms', 'self-reported pain', 'QoL', 'pain', 'efficacy and safety', 'sleep quality', 'pain, reduced anxiety and depression scores', 'central sensitisation, sleep quality, affective symptoms, change in QoL, adverse events during use and EEG correlations with symptoms', 'quality of life (QoL', 'anxiety', 'pain relief']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",16.0,0.158365,"Central sensitisation symptoms improved by a third ( p  < 0.0001), sleep quality by almost 50% ( p  < 0.001), anxiety reduced by 40% ( p  = 0.015), and QoL improved at final follow-up for 13 participants.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Birch', 'Affiliation': 'East Midlands Spine Ltd., Northampton, United Kingdom.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'PhysioFunction Ltd., Northampton, United Kingdom.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ozolins', 'Affiliation': 'Exsurgo Ltd., Auckland, New Zealand.'}, {'ForeName': 'Kaushalya', 'Initials': 'K', 'LastName': 'Kumarasinghe', 'Affiliation': 'Exsurgo Ltd., Auckland, New Zealand.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Almesfer', 'Affiliation': 'Exsurgo Ltd., Auckland, New Zealand.'}]","Frontiers in pain research (Lausanne, Switzerland)",['10.3389/fpain.2022.855493']
2395,35712442,Ophthalmic Complications Associated with Zygomatic Complex Fractures: A Randomised Descriptive Clinical Study.,"Background and Objectives


Trauma to the maxillofacial region is usually associated with varying degrees of disruption of the soft and hard tissues in the region and injuries to the neighbouring structures such as eyes, brain, nasal apparatus and paranasal sinuses. Injuries to the middle third of the face commonly destroys the integrity of the orbital skeleton, and are frequently complicated by injury to the eye, ranging between 2.7 and 67% as reported in the literature. These injuries may result in loss of vision or compromised ocular function. When these injuries are severe, they may be detected with ease by any medical or maxillofacial surgeon but many injuries appear minimal and may be missed by the non-ophthalmologist.
Methods


A total of thirty patients were selected who were diagnosed with a zygomatic complex fracture, irrespective of sex predilection and in the age group of 18-70 years. All patients underwent a thorough ophthalmic examination by an Oral and Maxillofacial Surgeon and an Ophthalmologist preoperatively and on postoperative day 2, and 7 and all findings were documented separately by the surgeon and the ophthalmologist and the findings were later compared.
Results


The statistical analysis was performed using SPSS VERSION 21.0, Shapiro-Wilk test which was used to assess the normality. Descriptive analysis was done for age and gender distribution of study subjects, which are expressed as number and frequency. Cochran's q test was used to determine if there are differences in various study factors among OMFS and ophthalmologists at three time intervals which are expressed as number and frequency. Kappa agreement was used to assess the measurement of agreement between OMFS and ophthalmologists for each factor at each time interval and these are expressed as number and frequency, and  p  ≤ 0.05 is considered as statistically significant. Upon examination by an OMFS periorbital oedema ( p  = 0.000), periorbital ecchymosis ( p  = 0.002), chemosis ( p  = 0.02) and exophthalmos ( p  = 0.03) were considered clinically significant. Upon examination by an ophthalmologist subconjunctival haemorrhage ( p  = 0.05), periorbital oedema ( p  = 0.05), periorbital ecchymosis ( p  = 0.00), ptosis ( p  = 0.006), enopthalmos ( p  = 0.05) and diplopia ( p  = 0.05) were considered to be clinically significant. Upon correlation of the findings of the surgeon and the ophthalmologist it was seen that certain parameters like corneal injury, Phthisis bulbing, examination of posterior segment can be better done by the ophthalmologist.
Interpretation and Conclusion


In conclusion, it was determined that there is a significant correlation between ophthalmic injuries caused by zygomatic complex fractures. There are a wide array of injuries affecting the eye due to trauma to the middle third of the face, and the superficial injury can be well evaluated and documented by a surgeon; however due to the extensive nature of the injuries in trauma and the importance of the eye, an ophthalmic examination cannot be ruled out. The need for evaluation of such injures deem it pertinent for observation by an ophthalmologist.",2022,"Upon examination by an OMFS periorbital oedema ( p  = 0.000), periorbital ecchymosis ( p  = 0.002), chemosis ( p  = 0.02) and exophthalmos ( p  = 0.03) were considered clinically significant.","['All patients underwent a thorough ophthalmic examination by an Oral and Maxillofacial Surgeon and an Ophthalmologist preoperatively and on postoperative day 2, and', 'Zygomatic Complex Fractures', 'thirty patients were selected who were diagnosed with a zygomatic complex fracture, irrespective of sex predilection and in the age group of 18-70\xa0years']",[],"['ptosis', 'periorbital oedema', 'Ophthalmic Complications', 'periorbital ecchymosis', 'periorbital ecchymosis ', 'diplopia', 'ophthalmologist subconjunctival haemorrhage', 'OMFS periorbital oedema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0260272', 'cui_str': 'Oral surgeon'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2053461', 'cui_str': 'Periorbital ecchymosis'}, {'cui': 'C0012569', 'cui_str': 'Diplopia'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage'}]",30.0,0.0490086,"Upon examination by an OMFS periorbital oedema ( p  = 0.000), periorbital ecchymosis ( p  = 0.002), chemosis ( p  = 0.02) and exophthalmos ( p  = 0.03) were considered clinically significant.","[{'ForeName': 'Rayan', 'Initials': 'R', 'LastName': 'Malick', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Vydehi Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Sham', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Vydehi Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Menon', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Vydehi Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Vydehi Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Archana', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Vydehi Institute of Dental Sciences and Research Centre, Bangalore, India.'}, {'ForeName': 'Sheron', 'Initials': 'S', 'LastName': 'Mathews', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Vydehi Institute of Dental Sciences and Research Centre, Bangalore, India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01441-9']
2396,35712435,Comparative Assessment of Microplates with Miniplates in the Fixation of Midface Fractures: A Prospective Study.,"Aim


The aim of this study was to compare the treatment outcome following fixation of midface fractures with microplates to that of miniplates.
Materials and Methods


The prospective study included 30 patients with confirmed diagnosis of midface fractures (Le Fort I, II, III, ZMC fractures or combination) and who gave written informed consent. The patients were categorized into microplate (1.2 mm) group and miniplate (2.0 mm) group with 15 patients in each group using computer-generated randomization. The clinical parameters like occlusion, stability of fixation, chewing efficiency, pain, infection, paresthesia, plate exposure, palpability, aesthetic outcomes and patient's perspective were assessed on postoperative day 1, day 3, after 1 week, 1 month and after 3 months.
Results


There was no statistically significant difference between the two groups in terms of occlusion, stability of fixation, chewing efficiency, pain, infection, paresthesia, plate exposure, aesthetic outcomes and patient's perspective. One patient in microplate group and five patients in miniplate group complained of plate palpability ( P  = 0.16), suggesting clinically significant difference but statistically no significant difference.
Conclusion


Microplate osteosynthesis gives equivalent results compared to miniplate osteosynthesis, in the fixation of midface fractures in terms of stability and function and clinically superior in terms of aesthetics.",2022,"There was no statistically significant difference between the two groups in terms of occlusion, stability of fixation, chewing efficiency, pain, infection, paresthesia, plate exposure, aesthetic outcomes and patient's perspective.","['30 patients with confirmed diagnosis of midface fractures (Le Fort I, II, III, ZMC fractures or combination) and who gave written informed consent', 'Microplates with Miniplates in the Fixation of Midface Fractures']",[],"['plate palpability', ""occlusion, stability of fixation, chewing efficiency, pain, infection, paresthesia, plate exposure, aesthetic outcomes and patient's perspective"", ""clinical parameters like occlusion, stability of fixation, chewing efficiency, pain, infection, paresthesia, plate exposure, palpability, aesthetic outcomes and patient's perspective""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",[],"[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.0210993,"There was no statistically significant difference between the two groups in terms of occlusion, stability of fixation, chewing efficiency, pain, infection, paresthesia, plate exposure, aesthetic outcomes and patient's perspective.","[{'ForeName': 'Tanvy', 'Initials': 'T', 'LastName': 'Sansgiri', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Gnanagangothri Campus, MSRIT Post, MSR Nagar, Bengaluru, Karnataka 560054 India.'}, {'ForeName': 'Kavitha', 'Initials': 'K', 'LastName': 'Prasad', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Gnanagangothri Campus, MSRIT Post, MSR Nagar, Bengaluru, Karnataka 560054 India.'}, {'ForeName': 'Vineeth', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Gnanagangothri Campus, MSRIT Post, MSR Nagar, Bengaluru, Karnataka 560054 India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ranganath', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Gnanagangothri Campus, MSRIT Post, MSR Nagar, Bengaluru, Karnataka 560054 India.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Rajanikanth', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Gnanagangothri Campus, MSRIT Post, MSR Nagar, Bengaluru, Karnataka 560054 India.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Sejal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Gnanagangothri Campus, MSRIT Post, MSR Nagar, Bengaluru, Karnataka 560054 India.'}, {'ForeName': 'Parimala', 'Initials': 'P', 'LastName': 'Sagar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Gnanagangothri Campus, MSRIT Post, MSR Nagar, Bengaluru, Karnataka 560054 India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Prathibha', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Gnanagangothri Campus, MSRIT Post, MSR Nagar, Bengaluru, Karnataka 560054 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01453-5']
2397,35714630,Mobile health school screening and telemedicine referral to improve access to specialty care in rural Alaska: a cluster- randomised controlled trial.,"BACKGROUND


School-based programmes, including hearing screening, provide essential preventive services for rural children. However, minimal evidence on screening methodologies, loss to follow-up, and scarcity of specialists for subsequent care compound rural health disparities. We hypothesised telemedicine specialty referral would improve time to follow-up for school hearing screening compared with standard primary care referral.
METHODS


In this cluster-randomised controlled trial conducted in 15 rural Alaskan communities, USA, we randomised communities to telemedicine specialty referral (intervention) or standard primary care referral (control) for school hearing screening. All children (K-12; aged 4-21 years) enrolled in Bering Straight School District were eligible. Community randomisation occurred within four strata using location and school size. Participants were masked to group allocation until screening day, and assessors were masked throughout data collection. Screening occurred annually, and children who screened positive for possible hearing loss or ear disease were monitored for 9 months from the screening date for follow-up. Primary outcome was the time to follow-up after a positive hearing screen; analysis was by intention to treat. The trial was registered with ClinicalTrials.gov, NCT03309553.
FINDINGS


We recruited participants between Oct 10, 2017, and March 28, 2019. 15 communities were randomised: eight (750 children) to telemedicine referral and seven (731 children) to primary care referral. 790 (53·3%) of 1481 children screened positive in at least one study year: 391 (52∤1%) in the telemedicine referral communities and 399 (50∤4%) in the primary care referral communities. Of children referred, 268 (68·5%) in the telemedicine referral communities and 128 (32·1%) in primary care referral communities received follow-up within 9 months. Among children who received follow-up, mean time to follow-up was 41·5 days (SD 55·7) in the telemedicine referral communities and 92·0 days (75·8) in the primary care referral communities (adjusted event-time ratio 17·6 [95% CI 6·8-45·3] for all referred children). There were no adverse events.
INTERPRETATION


Telemedicine specialty referral significantly improved the time to follow-up after hearing screening in Alaska. Telemedicine might apply to other preventive school-based services to improve access to specialty care for rural children.
FUNDING


Patient-Centered Outcomes Research Institute.",2022,"We hypothesised telemedicine specialty referral would improve time to follow-up for school hearing screening compared with standard primary care referral.
","['790 (53·3%) of 1481 children screened positive in at least one study year: 391 (52∤1%) in the telemedicine referral communities and 399 (50∤4%) in the primary care referral communities', 'Of children referred, 268 (68·5%) in the telemedicine referral communities and 128 (32·1%) in primary care referral communities', 'rural Alaska', 'rural children', '15 rural Alaskan communities, USA', 'All children (K-12; aged 4-21 years) enrolled in Bering Straight School District were eligible', 'We recruited participants between Oct 10, 2017, and March 28, 2019', '15 communities were randomised: eight (750 children) to telemedicine referral and seven (731 children) to primary care referral']","['Mobile health school screening and telemedicine referral', 'telemedicine specialty referral (intervention) or standard primary care referral (control) for school hearing screening', 'Telemedicine']","['time to follow-up after a positive hearing screen', 'possible hearing loss or ear disease']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1158530', 'cui_str': 'Base Excision Repair'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0013447', 'cui_str': 'Disorder of ear'}]",15.0,0.280726,"We hypothesised telemedicine specialty referral would improve time to follow-up for school hearing screening compared with standard primary care referral.
","[{'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Emmett', 'Affiliation': 'Department of Head and Neck Surgery and Communication Science, Duke University School of Medicine, Duke University, Durham, NC, USA; Duke Global Health Institute, Duke University, Durham, NC, USA; Center for Health Policy and Inequalities Research, Duke University, Durham, NC, USA. Electronic address: sdemmett@uams.edu.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Platt', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Gallo', 'Affiliation': 'Mixed Methods Research Training Program, Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alain B', 'Initials': 'AB', 'LastName': 'Labrique', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'S Meade', 'Initials': 'SM', 'LastName': 'Inglis', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA; Center for Health Policy and Inequalities Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'Cole D', 'Initials': 'CD', 'LastName': 'Jenson', 'Affiliation': 'Department of Audiology, Norton Sound Health Corporation, Nome, AK, USA.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Parnell', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA; Center for Health Policy and Inequalities Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kelli L', 'Initials': 'KL', 'LastName': 'Hicks', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Egger', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Halpin', 'Affiliation': 'School of Education, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yong', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; BC Rotary Hearing and Balance Centre, Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jeromie', 'Initials': 'J', 'LastName': 'Ballreich', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Samantha Kleindienst', 'Initials': 'SK', 'LastName': 'Robler', 'Affiliation': 'Department of Audiology, Norton Sound Health Corporation, Nome, AK, USA; Department of Population Health, Norton Sound Health Corporation, Nome, AK, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(22)00184-X']
2398,35714551,Withdrawing methylphenidate in relation to serum levels of ferritin and zinc in children and adolescents with attention-deficit/hyperactivity disorder.,"Iron and zinc have been associated with attention-deficit/hyperactivity disorder (ADHD), executive functioning, and response to methylphenidate, given their link with the dopaminergic system. This study aimed to investigate the effect of withdrawing methylphenidate after long-term treatment on serum levels of ferritin and zinc; and if baseline (pre-discontinuation) serum levels of these nutritional markers moderated the effects of withdrawing methylphenidate on ADHD and oppositional defiant disorder (ODD) symptoms, and working memory. Blood samples were collected from 63 children and adolescents who participated in a randomized, placebo-controlled methylphenidate discontinuation study. They were assigned to either seven weeks of continued treatment with methylphenidate or to gradual withdrawal to placebo. With mixed models for repeated measures we (i) compared changes in ferritin and zinc serum levels between both groups, and (ii) investigated moderating effects of ferritin and zinc on the effects of discontinuation on ADHD and ODD symptoms, and working memory. We additionally explored correlations of baseline and change serum levels with respective symptom scores. Withdrawing methylphenidate led to a decrease in ferritin levels. Higher baseline ferritin was associated with a larger increase (i.e., worsening) of teacher-rated hyperactivity-impulsivity and ODD symptoms after withdrawal; and higher baseline zinc with a larger increase in number of errors on the working memory task after withdrawal. Serum levels did not correlate with ADHD and ODD symptoms. Our preliminary results suggest that ferritin and zinc may be potential biomarkers for the effectiveness of long-term treatment with methylphenidate.",2022,"Higher baseline ferritin was associated with a larger increase (i.e., worsening) of teacher-rated hyperactivity-impulsivity and ODD symptoms after withdrawal; and higher baseline zinc with a larger increase in number of errors on the working memory task after withdrawal.","['63 children and adolescents who participated in a randomized', 'children and adolescents with attention-deficit/hyperactivity disorder']","['methylphenidate', 'placebo-controlled methylphenidate', 'placebo']","['serum levels of ferritin and zinc', 'number of errors on the working memory task', 'ADHD and oppositional defiant disorder (ODD) symptoms, and working memory', 'ADHD and ODD symptoms, and working memory', 'Serum levels', 'ferritin and zinc serum levels', 'ferritin levels', 'worsening) of teacher-rated hyperactivity-impulsivity and ODD symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}]",63.0,0.0684029,"Higher baseline ferritin was associated with a larger increase (i.e., worsening) of teacher-rated hyperactivity-impulsivity and ODD symptoms after withdrawal; and higher baseline zinc with a larger increase in number of errors on the working memory task after withdrawal.","[{'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Rosenau', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Child and Adolescent Psychiatry, Groningen, the Netherlands; Accare Child Study Center, Groningen, the Netherlands. Electronic address: p.rosenau@accare.nl.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'van den Hoofdakker', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Child and Adolescent Psychiatry, Groningen, the Netherlands; Accare Child Study Center, Groningen, the Netherlands.'}, {'ForeName': 'Anne-Flore M', 'Initials': 'AM', 'LastName': 'Matthijssen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Child and Adolescent Psychiatry, Groningen, the Netherlands.'}, {'ForeName': 'Gigi H H', 'Initials': 'GHH', 'LastName': 'van de Loo-Neus', 'Affiliation': 'Karakter Child and Adolescent Psychiatry Center Nijmegen, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': 'Karakter Child and Adolescent Psychiatry Center Nijmegen, Nijmegen, the Netherlands; Radboud University Nijmegen Medical Center, Donders Institute for Brain, Cognition and Behavior, Department of Cognitive Neuroscience, Nijmegen, the Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Hoekstra', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Child and Adolescent Psychiatry, Groningen, the Netherlands; Accare Child Study Center, Groningen, the Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dietrich', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Child and Adolescent Psychiatry, Groningen, the Netherlands; Accare Child Study Center, Groningen, the Netherlands.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.06.014']
2399,35714533,A qualitative study of smokers' assessments of four smoking cessation interventions delivered in a hospital emergency department.,"BACKGROUND


A recent clinical trial of 1056 adults who smoke tested the efficacy of four components of a treatment intervention initiated in a hospital emergency department (ED) and found two of them to be clinically effective. This paper explores study participants' attitudes towards the four components, whether they identified important interactions, and suggestions for further tailoring.
METHODS


Telephone interviews were conducted with participants at the end of the three-month study period. Each participant had received at least one intervention component: nicotine replacement therapy, referral to a smokers' telephone quitline, a brief negotiation interview, or the smartphone-enabled SmokefreeTXT program. Interviews were audio-recorded, transcribed, and analyzed using an iterative approach, grounded in the data, using thematic analysis.
RESULTS


Between March 2017 and September 2018, 63 interviews were conducted with participants who received at least one intervention component. The sample was diverse with respect to race, ethnicity, gender, and sociodemographic status. Intervention components were generally well-received by participants. Four themes were identified: Intervention Context, Intervention Content, Communications, and Recommendations. Provision of smoking cessation interventions to ED patients led to reduced self-reported smoking for most. Nicotine replacement therapy diminished cravings, while behavioral interventions provided social support that helped motivate and sustain behavior change.
CONCLUSIONS


Intervention components were feasible and acceptable. The data suggest that pharmacological and behavioral interventions be offered simultaneously, that communication skills training be provided to those who deliver the interventions, and that interventions should respect participants' autonomy and preferences concerning intervention timing, frequency, and termination.",2022,Provision of smoking cessation interventions to ED patients led to reduced self-reported smoking for most.,"['Between March 2017 and September 2018', ""smokers' assessments of four smoking cessation interventions delivered in a hospital emergency department"", '63 interviews were conducted with participants who received at least one intervention component', 'Telephone interviews were conducted with participants at the end of the three-month study period', '1056 adults who smoke']","[""intervention component: nicotine replacement therapy, referral to a smokers' telephone quitline, a brief negotiation interview, or the smartphone-enabled SmokefreeTXT program"", 'Nicotine replacement therapy']",[],"[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],1056.0,0.0399459,Provision of smoking cessation interventions to ED patients led to reduced self-reported smoking for most.,"[{'ForeName': 'Lauretta E', 'Initials': 'LE', 'LastName': 'Grau', 'Affiliation': 'Department of Epidemiology and Microbial Diseases, Yale School of Public Health, USA. Electronic address: lauretta.grau@yale.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jurczak', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mahrukh', 'Initials': 'M', 'LastName': 'Zahid', 'Affiliation': 'Department of Epidemiology and Microbial Diseases, Yale School of Public Health, USA.'}, {'ForeName': 'Avis Harper', 'Initials': 'AH', 'LastName': 'Brooks', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Teresa K', 'Initials': 'TK', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pham', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Bernstein', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA; Dartmouth-Hitchcock Medical Center, Hanover, NH, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109512']
2400,35714477,Matching-adjusted indirect treatment comparison of the efficacy of enzalutamide versus apalutamide for the treatment of nonmetastatic castration-resistant prostate cancer.,"BACKGROUND


To date, the efficacy of the androgen receptor inhibitors enzalutamide and apalutamide for the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC) has not been compared directly in a clinical trial setting. Indirect comparisons can be used to assess relative efficacy and provide important information to guide treatment decisions. PROSPER and SPARTAN were double-blind, randomized, placebo-controlled, phase III trials in patients with nmCRPC with overall similar study designs and inclusion and exclusion criteria. Using an anchored matching-adjusted indirect comparison, based on the final data from the PROSPER and SPARTAN studies, we assessed the comparative efficacy of enzalutamide and apalutamide, both plus androgen deprivation therapy.
METHODS


Using placebo as the common comparator, individual patient data from PROSPER were matched to the aggregate patient data from SPARTAN and efficacy endpoints from PROSPER were re-weighted accordingly. Patient baseline characteristics and endpoints were clinically and statistically tested to identify potential effect modifiers, according to National Institute for Health and Care Excellence guidelines. Hazard ratios for overall survival (OS), metastasis-free survival (MFS), and time to chemotherapy (TTCx) were re-estimated for PROSPER using weighted Cox proportional hazards models and indirectly compared with those of SPARTAN using a Bayesian network meta-analysis.
RESULTS


Estimated hazard ratios [95% credible interval (CrI)] for enzalutamide versus apalutamide were 0.80 (95% CrI 0.58-1.10) for OS, 0.94 (95% CrI 0.69-1.29) for MFS2, and 0.90 (95% CrI 0.63-1.29) for TTCx. Similar results were seen for sensitivity analyses conducted for OS and MFS. Bayesian probability analyses showed a 91.7% favoring enzalutamide for OS, 65.1% for MFS, and 71.4% for TTCx.
CONCLUSIONS


The results of this matching-adjusted indirect comparison of final data from PROSPER and SPARTAN indicate comparable efficacy of enzalutamide and apalutamide with potentially a greater probability of longer MFS, OS, and TTCx in patients with nmCRPC treated with enzalutamide versus apalutamide.",2022,"Bayesian probability analyses showed a 91.7% favoring enzalutamide for OS, 65.1% for MFS, and 71.4% for TTCx.
","['patients with nmCRPC treated with', 'nonmetastatic castration-resistant prostate cancer (nmCRPC', 'nonmetastatic castration-resistant prostate cancer', 'patients with nmCRPC with overall similar study designs and inclusion and exclusion criteria']","['enzalutamide versus apalutamide', 'enzalutamide', 'placebo', 'androgen receptor inhibitors enzalutamide and apalutamide']","['Hazard ratios for overall survival (OS), metastasis-free survival (MFS), and time to chemotherapy (TTCx']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.27939,"Bayesian probability analyses showed a 91.7% favoring enzalutamide for OS, 65.1% for MFS, and 71.4% for TTCx.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Institut de Recherche Clinique (IREC), Cliniques Universitaires Saint-Luc, Brussels, Belgium. Electronic address: bertrand.tombal@uclouvain.be.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, Sandra and Edward Meyer Cancer Center, New York, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Lurie Cancer Center, Northwestern University, Chicago, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ganguli', 'Affiliation': 'HEOR, Oncology, Medical Affairs, Astellas Pharma Inc., Chicago, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Solutions UK IQVIA, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sandin', 'Affiliation': 'Global Health and Value, Outcomes and Evidence, Oncology, Pfizer AB, Sollentuna, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bhadauria', 'Affiliation': 'HEOR, Oncology, Medical Affairs, Astellas Pharma Inc., Chicago, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Oh', 'Affiliation': 'HEOR, Oncology, Medical Affairs, Astellas Pharma Inc., Chicago, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Department of Surgery, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}]",ESMO open,['10.1016/j.esmoop.2022.100510']
2401,35714426,Educational intervention to support development of mentors' competence in mentoring culturally and linguistically diverse nursing students: A quasi-experimental study.,"BACKGROUND


Those who mentor nursing students from diverse backgrounds should be educationally prepared to provide safe, culturally appropriate mentoring in clinical learning environments.
OBJECTIVE


To evaluate the effects of an educational intervention on mentors' competence in mentoring culturally and linguistically diverse nursing students during clinical placement.
DESIGN


Nonrandomised, quasi-experimental study.
SETTINGS


The study was conducted at two hospitals located in Finland.
PARTICIPANTS


Mentors responsible for mentoring nursing students during clinical placements.
METHODS


The intervention group (n = 49) completed blended learning mentoring education containing a cultural competence component. The control group (n = 62) completed online mentoring education lacking a cultural competence component. Data were collected from both groups at baseline, immediately after education, and at six-months follow-up using the Mentors' Competence Instrument and Mentors' Cultural Competence Instrument. Wilcoxon signed-rank test and Mann-Whitney U test were used to determine differences before and after education. Mixed model for repeated measures was used to compare the differences between the two groups.
RESULTS


Pretest-posttest results revealed statistically significant improvements in both groups on general mentoring competences. Both groups evaluated their competence in cultural sensitivity and awareness highly throughout the study period. Following education, competence in cultural interaction and safety and cultural skills increased statistically significantly in the intervention group. The intervention group was statistically significantly more satisfied with mentoring education, and reported that it had statistically significantly higher impact on their ability and willingness to mentor students. Comparison between groups revealed statistically nonsignificant differences in mentors' competence in mentoring culturally and linguistically diverse nursing students following education.
CONCLUSIONS


The study provides evidence on the development and evaluation of education designed to improve mentors' competence in mentoring, which may help nursing students from diverse backgrounds overcome challenges faced during clinical placements. Reinforcement strategies following education are needed in order to facilitate the maintenance of competence over time.
TRIAL REGISTRATION



CLINICALTRIALS


gov (ID:NCT04280172).",2022,"Following education, competence in cultural interaction and safety and cultural skills increased statistically significantly in the intervention group.","[""mentors' competence in mentoring culturally and linguistically diverse nursing students during clinical placement"", 'Mentors responsible for mentoring nursing students during clinical placements', 'mentoring culturally and linguistically diverse nursing students', 'two hospitals located in Finland']","['educational intervention', 'Educational intervention', 'online mentoring education lacking a cultural competence component', 'blended learning mentoring education containing a cultural competence component']","[""mentors' competence"", 'satisfied with mentoring education', 'cultural interaction and safety and cultural skills', 'general mentoring competences']","[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0679748', 'cui_str': 'Cultural Competence'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",62.0,0.0293143,"Following education, competence in cultural interaction and safety and cultural skills increased statistically significantly in the intervention group.","[{'ForeName': 'Ashlee', 'Initials': 'A', 'LastName': 'Oikarainen', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Finland. Electronic address: ashlee.oikarainen@oulu.fi.'}, {'ForeName': 'Veera', 'Initials': 'V', 'LastName': 'Kaarlela', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Finland. Electronic address: veera.kaarlela@oulu.fi.'}, {'ForeName': 'Marjut', 'Initials': 'M', 'LastName': 'Heiskanen', 'Affiliation': 'Clinical Development, Education and Research Centre of Nursing, Kuopio University Hospital, Finland. Electronic address: Marjut.Heiskanen@kuh.fi.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Taam-Ukkonen', 'Affiliation': 'Clinical Development, Education and Research Centre of Nursing, Kuopio University Hospital, Finland. Electronic address: Minna.Taam-Ukkonen@kuh.fi.'}, {'ForeName': 'Inkeri', 'Initials': 'I', 'LastName': 'Lehtimaja', 'Affiliation': 'Department of Finnish, Finno-Ugrian and Scandinavian Studies, University of Helsinki, Finland. Electronic address: inkeri.lehtimaja@helsinki.fi.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Kärsämänoja', 'Affiliation': 'Oulu University Hospital, Finland. Electronic address: taina.karsamanoja@ppshp.fi.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Tuomikoski', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Finland; Oulu University of Applied Sciences, Finland. Electronic address: annukka.tuomikoski@oamk.fi.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kääriäinen', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Finland; Medical Research Center Oulu, Northern Ostrobothnia Hospital Disctrict, Oulu University Hospital, Finland. Electronic address: maria.kaariainen@oulu.fi.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tomietto', 'Affiliation': 'Department of Nursing, Midwifery and Health, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, United Kingdom. Electronic address: marco.tomietto@northumbria.ac.uk.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Mikkonen', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Finland. Electronic address: kristina.mikkonen@oulu.fi.'}]",Nurse education today,['10.1016/j.nedt.2022.105424']
2402,35714891,Factors Associated with Lower Preoperative Quality of Life in Patients with Chronic Limb Threatening Ischemia in the BEST-CLI Trial.,"OBJECTIVES


There is limited contemporary data regarding health-related quality of life (HRQOL) measures in patients with chronic limb-threatening ischemia (CLI).
METHODS


The Best Endovascular versus Best Surgical Therapy in Patients with CLI (BEST-CLI) trial is an ongoing, NIH-sponsored, multicenter, randomized controlled trial comparing revascularization strategies in patients with CLI. BEST-CLI baseline HRQOL measures were evaluated for patient-specific variables that were associated with poor HRQOL and then compared with published outcomes. The HRQOL measures VascQOL (Vascular Quality of Life Questionnaire), EQ-5D (EuroHRQOL 5D), and SF-12 Index, physical component (PCS) and mental component (MCS) scores were aggregated from preoperative questionnaires completed by trial subjects at baseline visits. Multivariable linear regression models were fit to determine which baseline characteristics were associated with poor HRQOL.
RESULTS


1830 subjects were randomized into BEST-CLI. The majority (94.9%, 95.8%, and 95.8%) completed the VascQOL, EQ5D, and SF-12 instruments at baseline. In VascQOL, female sex, smoking history, opioid use, and non-independent ambulation predicted lower HRQOL scores. Overall, VascuQOL scores were similar to those of participants in the Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL) [(3.07(1.2)) vs 2.9(1.1)), P=.07]. In EQ5D, non-independent ambulation predicted lower HRQOL scores. In SF-12, female sex, opioid use, non-independent ambulation and history of smoking predicted lower HRQOL scores. The mean (standard deviation) SF-12 PCS for all patients in the study was 33.0(8.5) and for MCS was 46.4(12.0), significantly lower than the national SF-12 scores for US population over 60 years of age which is PCS of 46.5(11.4) and MCS of 52.9 (8.7).
CONCLUSIONS


Patients with CLI entering the BEST-CLI trial have very low HRQOL scores comparable to patients suffering from other chronic conditions characterized by physical limitation and chronic pain. A history of smoking, impaired ambulation, opioid use, and female sex predicted lower HRQOL in CLI patients, using multiple HRQOL measurement tools.",2022,"In SF-12, female sex, opioid use, non-independent ambulation and history of smoking predicted lower HRQOL scores.","['1830 subjects', 'Patients with CLI (BEST-CLI', 'patients with chronic limb-threatening ischemia (CLI', 'patients with CLI', 'Patients with Chronic Limb Threatening Ischemia in the BEST-CLI Trial']",[],"['HRQOL scores', 'mean (standard deviation) SF-12 PCS', 'Overall, VascuQOL scores', 'Severe Ischemia of the Leg (BASIL', 'BEST-CLI baseline HRQOL measures', 'VascQOL, EQ5D, and SF-12 instruments', 'MCS) scores', 'HRQOL measures VascQOL (Vascular Quality of Life Questionnaire), EQ-5D (EuroHRQOL 5D), and SF-12 Index, physical component (PCS) and mental component']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0600402', 'cui_str': 'Ocimum basilicum'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",1830.0,0.0825686,"In SF-12, female sex, opioid use, non-independent ambulation and history of smoking predicted lower HRQOL scores.","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Powell', 'Affiliation': 'Professor and Chief Section of Vascular Surgery Dartmouth Hitchcock Medical Center and Geisel School of Medicine at Dartmouth, Lebanon and Hanover, NH. Electronic address: Richard.J.Powell@hitchcock.org.'}, {'ForeName': 'Niteesh', 'Initials': 'N', 'LastName': 'Choudhry', 'Affiliation': 'Professor, Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Conte', 'Affiliation': 'Professor and Chief Division of Vascular and Endovascular Surgery, University of California, San Francisco, CA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cziraky', 'Affiliation': 'HealthCore, Watertown, MA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Giles', 'Affiliation': 'Section Chief of Vascular Surgery, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Taye', 'Initials': 'T', 'LastName': 'Hamza', 'Affiliation': 'HealthCore, Watertown, MA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Menard', 'Affiliation': ""Associate Professor, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Rosenfeld', 'Affiliation': 'Assistant Professor and Section Head Vascular Medicine and Interventional Cardiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rowe', 'Affiliation': 'Professor of Clinical Surgery, Division of Vascular Surgery, Keck School of Medicine of University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Siracuse', 'Affiliation': 'Associate Professor, Vascular and Endovascular Surgery, Boston Medical Center, Boston, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Strong', 'Affiliation': ""Senior Trial Manager, Brigham and Woman's Hospital, Boston, MA.""}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Van Over', 'Affiliation': 'HealthCore, Watertown, MA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Villarreal', 'Affiliation': 'Trial Manager, Boston Medical Center, Boston, MA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'White', 'Affiliation': 'Professor, System Chairman for Cardiovascular Disease, John Ochsner Heart and Vascular Institute, New Orleans, LA.'}, {'ForeName': 'Alik', 'Initials': 'A', 'LastName': 'Farber', 'Affiliation': 'Professor and Chief of Vascular and Endovascular Surgery, Boston Medical Center, Boston, MA.'}]",Journal of vascular surgery,['10.1016/j.jvs.2022.06.004']
2403,35714884,High Intensity Interval Training reduces hypoglycemic events compared with continuous aerobic training in individuals with type 1 diabetes: HIIT and hypoglycemia in type 1 diabetes.,"AIMS


to investigate if a High Intensity Interval Training (HIIT) protocol improves glycemic control and fitness capacity, compared to traditional moderate Intensity Continuous Training (MICT) exercise.
METHODS


30 sedentary individuals with type 1 diabetes (T1D) and 26 healthy controls were assigned to a 3-week HIIT or MICT protocol. Blood glucose levels by continuous glucose monitoring system and fitness status were compared before and after the study period.
RESULTS


During workouts, blood glucose levels remained stable in HIIT exercise (+3.2 ± 16.2 mg/dl (p = 0.43)), while decreased in MICT (-27.1 ± 17.5 mg/dl (p < 0.0001)) exercise. In addition, out of the 9 training sessions, HIIT volunteers needed to take carbohydrate supplements to avoid hypoglycemia in 0.56 ± 0.9 sessions, compared to 1.83 ± 0.5 sessions (p < 0.04) in MICT individuals. In the analysis of blood glucose levels between rest and training days (24h-period), training significantly reduced mean glycemic levels in both groups, but the MICT exercise results in an increase in the frequency of hypoglycemic episodes. The response to exercise seems to be attenuated in individuals with T1D, especially in HIIT group.
CONCLUSION


HIIT training results in a greater glycemic stability, with reduction of hypoglycemic episodes.",2022,"During workouts, blood glucose levels remained stable in HIIT exercise (+3.2 ± 16.2 mg/dl (p = 0.43)), while decreased in MICT (-27.1 ± 17.5 mg/dl (p < 0.0001)) exercise.","['30 sedentary individuals with type 1 diabetes (T1D) and 26 healthy controls', 'individuals with T1D, especially in HIIT group', 'individuals with type 1 diabetes']","['MICT exercise', 'HIIT training', 'High Intensity Interval Training (HIIT) protocol', 'HIIT or MICT protocol', 'continuous aerobic training', 'High Intensity Interval Training', 'traditional moderate Intensity Continuous Training (MICT) exercise']","['hypoglycemic episodes', 'glycemic control and fitness capacity', 'mean glycemic levels', 'Blood glucose levels', 'blood glucose levels remained stable in HIIT exercise', 'hypoglycemic events', 'blood glucose levels', 'glycemic stability', 'frequency of hypoglycemic episodes']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",30.0,0.00516998,"During workouts, blood glucose levels remained stable in HIIT exercise (+3.2 ± 16.2 mg/dl (p = 0.43)), while decreased in MICT (-27.1 ± 17.5 mg/dl (p < 0.0001)) exercise.","[{'ForeName': 'Serafin Murillo', 'Initials': 'SM', 'LastName': 'García', 'Affiliation': 'IDIBAPS, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain; CIBERDEM, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders, Barcelona, Spain; Hospital Clinic de Barcelona, Barcelona, Spain; Sant Joan de Déu Hospital, Barcelona, Spain; Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brugnara', 'Affiliation': 'IDIBAPS, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain; CIBERDEM, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders, Barcelona, Spain; Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joan-Marc', 'Initials': 'JM', 'LastName': 'Servitja', 'Affiliation': 'IDIBAPS, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain; CIBERDEM, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders, Barcelona, Spain.'}, {'ForeName': 'Anna Novials', 'Initials': 'AN', 'LastName': 'Sardà', 'Affiliation': 'IDIBAPS, August Pi i Sunyer Biomedical Research Institute, Barcelona, Spain; CIBERDEM, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders, Barcelona, Spain; Hospital Clinic de Barcelona, Barcelona, Spain. Electronic address: anovials@clinic.cat.'}]",Diabetes & metabolism,['10.1016/j.diabet.2022.101361']
2404,35714812,"Phase IIa, randomised, double-blind study of GSK3389404 in patients with chronic hepatitis B on stable nucleos(t)ide therapy.","BACKGROUND & AIMS


GSK3389404, an antisense oligonucleotide targeting hepatitis B virus (HBV) pregenomic and mRNA transcripts, is conjugated to N-acetyl galactosamine for enhanced hepatocyte delivery. This dose-finding study was the first to assess GSK3389404 in chronic HBV infection.
METHODS


This Phase 2a, randomised, double-blind, placebo-controlled, 2-part study was conducted in 22 centres in Asia (NCT03020745). Pharmacokinetic (PK) findings from Part 1 informed Part 2 dosing. In Part 2, patients with chronic hepatitis B on nucleos(t)ide analogue therapy were randomised 11:2 to GSK3389404 (30, 60, 120 mg weekly or 120 mg bi-weekly) or placebo until Day 85. Coprimary endpoints included HBsAg response (≥1.5 log 10  IU/mL reduction from baseline) rate, safety and PK.
RESULTS


Parts 1 and 2 included 12 (9 GSK3389404, 3 placebo) and 66 patients (56 GSK3389404, 10 placebo), respectively. In Part 2, one patient each in the 60 mg weekly, 120 mg weekly and 120 mg biweekly arms achieved a HBsAg response. HBsAg reductions were dose-dependent (Day 85: mean 0.34 [60 mg weekly] to 0.75 log 10  IU/mL [120 mg weekly]) and occurred in hepatitis B e antigen-positive and -negative patients. No patient achieved HBsAg seroclearance. 43/56 (77%) GSK3389404-treated and 9/10 (90%) placebo patients reported adverse events. No deaths were reported. Alanine aminotransferase flares (>2x upper limit of normal) occurred in two GSK3389404-treated patients (120 mg weekly, 120 mg bi-weekly); both were associated with decreased HBsAg, but neither was considered a responder. GSK3389404 plasma concentrations peaked 2-4 hours post dose; mean plasma half-life was 3-5 hours.
CONCLUSIONS


GSK3389404 showed an acceptable safety profile and target engagement, with dose-dependent reductions in HBsAg. However, no efficacious dosing regimen was identified.
CLINICAL TRIAL NUMBER


NCT03020745 LAY SUMMARY: Hepatitis B virus (HBV) can result in chronic HBV infection, which may ultimately lead to chronic liver disease, primary liver cancer and death; HBV proteins may prevent the immune system from successfully controlling the virus. GSK3389404 is an investigational agent that targets HBV RNA, resulting in reduced viral protein production. This study assessed the safety of GSK3389404 and its ability to reduce the viral proteins in patients with chronic HBV infection. GSK3389404 showed dose-dependent reduction in hepatitis B surface antigen, with an acceptable safety profile. While no clear optimal dose was identified, the findings from this study may help in the development of improved treatment options for patients with chronic HBV infections.",2022,HBsAg reductions were dose-dependent (Day 85: mean 0.34 [60 mg weekly] to 0.75 log 10  IU/mL,"['patients with chronic hepatitis B on nucleos(t)ide analogue therapy', 'patients with chronic HBV infection', 'patients with chronic hepatitis B on stable nucleos(t)ide therapy', '22 centres in Asia (NCT03020745', 'patients with chronic HBV infections']",['placebo'],"['adverse events', 'baseline) rate, safety and PK', 'HBsAg response', 'hepatitis B surface antigen', 'HBsAg seroclearance', 'HBsAg reductions', 'Alanine aminotransferase flares', 'hepatitis B e antigen-positive and -negative patients', 'GSK3389404 plasma concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003980', 'cui_str': 'Asia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0392390', 'cui_str': 'Hepatitis B e antigen positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.128593,HBsAg reductions were dose-dependent (Day 85: mean 0.34 [60 mg weekly] to 0.75 log 10  IU/mL,"[{'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine and State Key Laboratory of Liver Research, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China. Electronic address: mfyuen@hku.hk.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University, and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Kumada', 'Affiliation': 'Department of Hepatology, Toranomon Hospital Kajigaya, Kanagawa, Japan.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Suzuki', 'Affiliation': 'Department of Hepatology, Toranomon Hospital Kajigaya, Kanagawa, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Hepatology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yoshiyasu', 'Initials': 'Y', 'LastName': 'Karino', 'Affiliation': 'Department of Hepatology, Hokkaido P.W.F.a.C. Sapporo-Kosei General Hospital, Hokkaido, Japan.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Chayama', 'Affiliation': 'Collaborative Research Laboratory of Medical Innovation, Hiroshima University, Hiroshima, Japan; Research Center for Hepatology and Gastroenterology, Hiroshima University, Hiroshima, Japan; RIKEN Center for Integrative Medical Sciences, Yokohama, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Imamura', 'Affiliation': 'Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Judy Y', 'Initials': 'JY', 'LastName': 'Lao-Tan', 'Affiliation': 'Gastroenterology, Cebu Doctors University Hospital, Cebu, Philippines.'}, {'ForeName': 'Seng Gee', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'Division of Gastroenterology & Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Artifical Liver Center, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kurosaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Sung-Jae', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Gastroenterology and Hepatology, Inje University Busan Paik Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Madalinee Eternity', 'Initials': 'ME', 'LastName': 'Labio', 'Affiliation': 'Section of Gastroenterology and Hepatology, Department of Medicine, Makati Medical Center, Makati, Philippines.'}, {'ForeName': 'Rajneesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Young-Oh', 'Initials': 'YO', 'LastName': 'Kweon', 'Affiliation': 'Division of Gastroenterology and Hepatology, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Yim', 'Affiliation': 'Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'R&D Projects Clinical Platforms and Sciences, GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cremer', 'Affiliation': 'Hepatology GI Clinical Sciences, GlaxoSmithKline, NC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Elston', 'Affiliation': 'Hepatology GI Clinical Sciences, GlaxoSmithKline, Hertfordshire, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Global Safety, GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Baptiste-Brown', 'Affiliation': 'RD Projects Clinical Platforms and Sciences, GSK GlaxoSmithKline PA, USA.'}, {'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'RD Projects Clinical Platforms and Sciences, GSK GlaxoSmithKline PA, USA.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Campbell', 'Affiliation': 'Hepatology GI Clinical Sciences, GlaxoSmithKline, Hertfordshire, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Paff', 'Affiliation': 'RD Projects Clinical Platforms and Sciences, GSK GlaxoSmithKline PA, USA.'}, {'ForeName': 'Dickens', 'Initials': 'D', 'LastName': 'Theodore', 'Affiliation': 'Hepatology GI Clinical Sciences, GlaxoSmithKline, NC, USA.'}]",Journal of hepatology,['10.1016/j.jhep.2022.05.031']
2405,35714806,Results of a prospective randomized trial on long-term effectiveness of protons and carbon ions in prostate cancer: LEM I and α/β=2Gy overestimates the RBE.,"AIM


To analyze the long-term effectiveness of carbon ions relative to protons in the prospective randomized controlled ion prostate irradiation (IPI) trial.
METHODS


Effectiveness via PSA assessment in a randomized study on prostate irradiation with 20x3.3Gy(RBE) protons versus carbon ions was analyzed in 92 patients. Proton RBE was based on a fixed RBE of 1.1 while the local effect model (LEM) I and an α/β=2Gy was used for carbon ions. The dose in the prostate was recalculated based on the delivered treatment plan using LEM I and LEM IV and different α/β values.
RESULTS


Five-year overall and progression free survival was 98% and 85% with protons and 91% and 50% with carbon ions, respectively, with the latter being unexpectedly low compared to Japanese carbon ion data and rather corresponding to a photon dose <72 Gy in 2 Gy fractions. According to LEM I and the applied α/β-value of 2Gy, the applied carbon ion dose in 2 Gy(RBE) fractions (EQD2) was 87.46 Gy(RBE). Recalculations confirmed a strong dependence of RBE-weighted dose on the α/β ratio as well as on the RBE-model.
CONCLUSION


The data demonstrate a significant lower effectiveness of the calculated RBE-weighted dose in the carbon ion as compared to the proton arm. LEM I and an α/β = 2 Gy overestimates the RBE for carbon ions in prostate cancer treatment. Adjusting the biological dose calculation by using LEM I with α/β=4 Gy could be a pragmatic way to safely escalate dose in carbon ion radiotherapy for prostate cancer.",2022,"RESULTS


Five-year overall and progression free survival was 98% and 85% with protons and 91% and 50% with carbon ions, respectively, with the latter being unexpectedly low compared to Japanese carbon ion data and rather corresponding to a photon dose <72 Gy in 2 Gy fractions.","['92 patients', 'prostate cancer']","['carbon ion radiotherapy', 'protons and carbon ions', 'Proton RBE']","['local effect model (LEM', 'progression free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C3494442', 'cui_str': 'Carbon Ion Therapy'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0035023', 'cui_str': 'Biological Effectiveness, Relative'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0512863,"RESULTS


Five-year overall and progression free survival was 98% and 85% with protons and 91% and 50% with carbon ions, respectively, with the latter being unexpectedly low compared to Japanese carbon ion data and rather corresponding to a photon dose <72 Gy in 2 Gy fractions.","[{'ForeName': 'Eichkorn', 'Initials': 'E', 'LastName': 'Tanja', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; National Center for Tumor diseases (NCT), Heidelberg, Germany; Heidelberg Ion Beam Therapy Center (HIT), Im Neuenheimer Feld 450, 69120 Heidelberg, Germany. Electronic address: Tanja.Eichkorn@med.uni-heidelberg.de.'}, {'ForeName': 'P Karger', 'Initials': 'PK', 'LastName': 'Christian', 'Affiliation': 'National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; Dept. of Medical Physics in Radiation Oncology, German Cancer Research Center, Heidelberg, Germany. Electronic address: c.karger@dkfz.de.'}, {'ForeName': 'Brons', 'Initials': 'B', 'LastName': 'Stephan', 'Affiliation': 'National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120 Heidelberg, Germany. Electronic address: Stephan.Brons@med.uni-heidelberg.de.'}, {'ForeName': 'Koerber Stefan', 'Initials': 'KS', 'LastName': 'Alexander', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; National Center for Tumor diseases (NCT), Heidelberg, Germany; Heidelberg Ion Beam Therapy Center (HIT), Im Neuenheimer Feld 450, 69120 Heidelberg, Germany. Electronic address: Stefan.Koerber@med.uni-heidelberg.de.'}, {'ForeName': 'Mielke', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; Heidelberg Ion Beam Therapy Center (HIT), Im Neuenheimer Feld 450, 69120 Heidelberg, Germany. Electronic address: thomas.mielke@med.uni-heidelberg.de.'}, {'ForeName': 'Haberer', 'Initials': 'H', 'LastName': 'Thomas', 'Affiliation': 'National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; Heidelberg Ion Beam Therapy Center (HIT), Im Neuenheimer Feld 450, 69120 Heidelberg, Germany. Electronic address: Thomas.Haberer@med.uni-heidelberg.de.'}, {'ForeName': 'Debus', 'Initials': 'D', 'LastName': 'Juergen', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; National Center for Tumor diseases (NCT), Heidelberg, Germany; Clinical Cooperation Unit Radiation Oncology (E050), German Cancer Research Center (DKFZ), Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Heidelberg Ion Beam Therapy Center (HIT), Im Neuenheimer Feld 450, 69120 Heidelberg, Germany; German Cancer Consortium (DKTK), Partner Site Heidelberg, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 280, 69120 Heidelberg, Germany. Electronic address: Juergen.Debus@med.uni-heidelberg.de.'}, {'ForeName': 'Herfarth', 'Initials': 'H', 'LastName': 'Klaus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; National Center for Tumor diseases (NCT), Heidelberg, Germany; Heidelberg Ion Beam Therapy Center (HIT), Im Neuenheimer Feld 450, 69120 Heidelberg, Germany. Electronic address: Klaus.Herfarth@med.uni-heidelberg.de.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2022.06.006']
2406,35714786,"Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: a post hoc integrated analysis of three phase 3 randomized, double-blind, placebo-controlled trials.","BACKGROUND


Acne is the most frequent adverse event (AE) associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis (AD).
OBJECTIVE


To characterize the AE of acne associated with upadacitinib.
METHODS


This was a post hoc integrated analysis of three phase 3 randomized, double-blind, placebo-controlled trials of upadacitinib, alone (NCT03569293 and NCT03607422) or in combination with topical corticosteroids (NCT03568318). Data included were from the 16-week placebo-controlled period.
RESULTS


Over 16 weeks, 84/857 (9.8%), 131/864 (15.2%), and 19/862 (2.2%) patients randomized to receive upadacitinib 15 mg, upadacitinib 30 mg, and placebo, respectively, experienced acne. All cases of acne, except 1, were mild/moderate in severity; 2 patients discontinued treatment due to moderate acne. Acne occurred at higher rates among younger, female, and non-White patients. Acne required no intervention in 40.5% and 46.6% of patients receiving upadacitinib 15 or 30 mg, respectively; most remaining cases were managed with topical antibiotics, benzoyl peroxide, and/or retinoids. Acne also had no impact on patient-reported outcomes.
LIMITATIONS


This study was relatively short in duration and had a small patient population.
CONCLUSIONS


Acne associated with upadacitinib for AD treatment is usually mild/moderate in severity and managed with topical therapies or no intervention.",2022,"Acne required no intervention in 40.5% and 46.6% of patients receiving upadacitinib 15 or 30 mg, respectively; most remaining cases were managed with topical antibiotics, benzoyl peroxide, and/or retinoids.","['patients with moderate-to-severe atopic dermatitis', 'patients with moderate-to-severe atopic dermatitis (AD']","['upadacitinib 15 mg, upadacitinib 30 mg, and placebo', 'placebo', 'upadacitinib treatment']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C5196293', 'cui_str': 'upadacitinib 15 MG [Rinvoq]'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.390894,"Acne required no intervention in 40.5% and 46.6% of patients receiving upadacitinib 15 or 30 mg, respectively; most remaining cases were managed with topical antibiotics, benzoyl peroxide, and/or retinoids.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mendes-Bastos', 'Affiliation': 'Dermatology Center, Hospital CUF Descobertas, Lisboa, Portugal.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ladizinski', 'Affiliation': 'AbbVie Inc., North Chicago.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology and the Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'AbbVie Inc., North Chicago.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'AbbVie Inc., North Chicago.'}, {'ForeName': 'Vimal H', 'Initials': 'VH', 'LastName': 'Prajapati', 'Affiliation': 'Division of Dermatology, Department of Medicine, Section of Community Pediatrics, Department of Pediatrics, and Section of Pediatric Rheumatology, Department of Pediatrics, University of Calgary, Calgary, Alberta; and Dermatology Research Institute, Calgary, Alberta, Skin Health & Wellness Centre, Calgary, Alberta, and Probity Medical Research, Calgary, Alberta.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Vigna', 'Affiliation': 'AbbVie Inc., North Chicago.'}, {'ForeName': 'Henrique D', 'Initials': 'HD', 'LastName': 'Teixeira', 'Affiliation': 'AbbVie Inc., North Chicago.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Barbarot', 'Affiliation': 'Dermatology Department, Nantes Université, University Hospital of Nantes, UMR, INRAE, Nantes, France.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2022.06.012']
2407,35714735,AAV2-hCHM Subretinal Delivery to the Macula in Choroideremia: Two Year Interim Results of an Ongoing Phase I/II Gene Therapy Trial.,"PURPOSE


To assess the safety of the subretinal delivery of a recombinant adeno-associated virus serotype 2 (AAV2) vector carrying a human CHM-encoding cDNA in choroideremia (CHM).
DESIGN


Prospective, open-label, non-randomized, dose-escalation, phase 1/2 clinical trial.
SUBJECTS, PARTICIPANTS, AND/OR CONTROLS


Fifteen CHM patients (ages 20-57 years at dosing).
METHODS, INTERVENTION, OR TESTING


Patients received uniocular subfoveal injections of low dose (up to 5x10 10  vector genome (vg) per eye, n=5) or high dose (up to 1x10 11  vg per eye, n=10) AAV2-hCHM. Patients were evaluated pre- and post-operatively for two years with ophthalmic examinations, multimodal retinal imaging and psychophysical testing.
MAIN OUTCOME


Measures: visual acuity (VA), perimetry (10-2 protocol), spectral-domain optical coherence tomography (SD-OCT) and short-wavelength fundus autofluorescence (SW-FAF).
RESULTS


We detected no vector-related or systemic toxicities. VA returned to within 15 letters of baseline in all but two patients (one developed acute foveal thinning, another patient, a macular hole); the rest showed no gross changes in foveal structure at two years. There were no significant differences between intervention and control eyes in mean light-adapted sensitivity by perimetry, or in the lateral extent of retinal pigment epithelium (RPE) relative preservation by SD-OCT and SW-FAF. Microperimetry showed non-significant (<3SD of the intervisit variability) gains in sensitivity in some locations and participants in the intervention eye. There were no obvious dose-dependent relationships.
CONCLUSIONS


VA was within 15 letters of baseline after the subfoveal AAV2-hCHM injections in 13/15 (87%) of the patients. Acute foveal thinning with unchanged perifoveal function in one patient and macular hole in a second suggests foveal vulnerability to the subretinal injections. Longer observation intervals will help establish the significance of the minor differences in sensitivities and rate of disease progression observed between intervention and control eyes.",2022,"There were no significant differences between intervention and control eyes in mean light-adapted sensitivity by perimetry, or in the lateral extent of retinal pigment epithelium (RPE) relative preservation by SD-OCT and SW-FAF.","['Patients were evaluated pre- and post-operatively for two years with ophthalmic examinations, multimodal retinal imaging and psychophysical testing', 'Fifteen CHM patients (ages 20-57 years at dosing', 'Choroideremia']","['AAV2-hCHM Subretinal Delivery', 'recombinant adeno-associated virus serotype 2 (AAV2) vector carrying a human CHM-encoding cDNA', 'uniocular subfoveal injections of low dose (up to 5x10 10  vector genome (vg) per eye, n=5) or high dose (up to 1x10 11  vg per eye, n=10) AAV2-hCHM']","['vector-related or systemic toxicities', 'sensitivities and rate of disease progression', 'visual acuity (VA), perimetry (10-2 protocol), spectral-domain optical coherence tomography (SD-OCT) and short-wavelength fundus autofluorescence (SW-FAF', 'foveal structure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0008525', 'cui_str': 'Choroideremia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C2699708', 'cui_str': 'Subretinal route'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1564874', 'cui_str': 'Adeno-Associated Viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0008525', 'cui_str': 'Choroideremia'}, {'cui': 'C0006556', 'cui_str': 'Complementary DNA'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4552199', 'cui_str': 'Systemic toxicity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0031061', 'cui_str': 'Perimetry'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C4324299', 'cui_str': 'Fundus autofluorescence'}]",,0.124973,"There were no significant differences between intervention and control eyes in mean light-adapted sensitivity by perimetry, or in the lateral extent of retinal pigment epithelium (RPE) relative preservation by SD-OCT and SW-FAF.","[{'ForeName': 'Tomas S', 'Initials': 'TS', 'LastName': 'Aleman', 'Affiliation': ""Scheie Eye Institute at the Perelman Center for Advanced Medicine; The Center for Advanced Retinal & Ocular Therapeutics; The Children's Hospital of Philadelphia, Department of Ophthalmology, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: aleman@pennmedicine.upenn.edu.""}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Huckfeldt', 'Affiliation': 'Ocular Genomics Institute, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Leona W', 'Initials': 'LW', 'LastName': 'Serrano', 'Affiliation': 'Scheie Eye Institute at the Perelman Center for Advanced Medicine; The Center for Advanced Retinal & Ocular Therapeutics.'}, {'ForeName': 'Denise J', 'Initials': 'DJ', 'LastName': 'Pearson', 'Affiliation': 'Scheie Eye Institute at the Perelman Center for Advanced Medicine; The Center for Advanced Retinal & Ocular Therapeutics.'}, {'ForeName': 'Grace K', 'Initials': 'GK', 'LastName': 'Vergilio', 'Affiliation': 'Scheie Eye Institute at the Perelman Center for Advanced Medicine; The Center for Advanced Retinal & Ocular Therapeutics.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McCague', 'Affiliation': ""The Center for Advanced Retinal & Ocular Therapeutics; The Children's Hospital of Philadelphia, Department of Ophthalmology, University of Pennsylvania, Philadelphia, PA, United States.""}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Marshall', 'Affiliation': ""The Center for Advanced Retinal & Ocular Therapeutics; The Children's Hospital of Philadelphia, Department of Ophthalmology, University of Pennsylvania, Philadelphia, PA, United States.""}, {'ForeName': 'Manzar', 'Initials': 'M', 'LastName': 'Ashtari', 'Affiliation': ""The Center for Advanced Retinal & Ocular Therapeutics; The Children's Hospital of Philadelphia, Department of Ophthalmology, University of Pennsylvania, Philadelphia, PA, United States.""}, {'ForeName': 'Tu M', 'Initials': 'TM', 'LastName': 'Doan', 'Affiliation': 'Ocular Genomics Institute, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Weigel-DiFranco', 'Affiliation': 'Ocular Genomics Institute, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Bethany S', 'Initials': 'BS', 'LastName': 'Biron', 'Affiliation': 'Ocular Genomics Institute, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Wen', 'Affiliation': 'Ocular Genomics Institute, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Chung', 'Affiliation': 'Spark Therapeutics, Philadelphia, PA, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Spark Therapeutics, Philadelphia, PA, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ferenchak', 'Affiliation': 'Ocular Genomics Institute, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jessica I W', 'Initials': 'JIW', 'LastName': 'Morgan', 'Affiliation': 'Scheie Eye Institute at the Perelman Center for Advanced Medicine; The Center for Advanced Retinal & Ocular Therapeutics.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Pierce', 'Affiliation': 'Ocular Genomics Institute, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Eliott', 'Affiliation': 'Ocular Genomics Institute, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Scheie Eye Institute at the Perelman Center for Advanced Medicine; The Center for Advanced Retinal & Ocular Therapeutics.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Comander', 'Affiliation': 'Ocular Genomics Institute, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Albert M', 'Initials': 'AM', 'LastName': 'Maguire', 'Affiliation': ""Scheie Eye Institute at the Perelman Center for Advanced Medicine; The Center for Advanced Retinal & Ocular Therapeutics; The Children's Hospital of Philadelphia, Department of Ophthalmology, University of Pennsylvania, Philadelphia, PA, United States.""}]",Ophthalmology,['10.1016/j.ophtha.2022.06.006']
2408,35715450,Influences of social uncertainty and serotonin on gambling decisions.,"In many instances in life, our decisions' outcomes hinge on someone else's choices (i.e., under social uncertainty). Behavioral and pharmacological work has previously focused on different types of uncertainty, such as risk and ambiguity, but not so much on risk behaviors under social uncertainty. Here, in two different studies using a double-blind, placebo-controlled, within-subject design, we administrated citalopram (a selective-serotonin-reuptake inhibitor) to male participants and investigated decisions in a gambling task under social and nonsocial uncertainty. In the social condition, gamble outcomes were determined by another participant. In the nonsocial condition, gamble outcomes were determined by a coin toss. We observed increased gamble acceptance under social uncertainty, especially for gambles with lower gains and higher losses, which might be indicative of a positivity bias in social expectations in conditions of high uncertainty about others' behaviors. A similar effect was found for citalopram, which increased overall acceptance behavior for gambles irrespective of the source of uncertainty (social/nonsocial). These results provide insights into the cognitive and neurochemical processes underlying decisions under social uncertainty, with implications for research in risk-taking behaviors in healthy and clinical populations.",2022,"A similar effect was found for citalopram, which increased overall acceptance behavior for gambles irrespective of the source of uncertainty (social/nonsocial).",['male participants and investigated decisions in a gambling task under social and nonsocial uncertainty'],"['citalopram', 'placebo', 'citalopram (a selective-serotonin-reuptake inhibitor']","['overall acceptance behavior', 'gamble acceptance under social uncertainty']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}]",,0.0497701,"A similar effect was found for citalopram, which increased overall acceptance behavior for gambles irrespective of the source of uncertainty (social/nonsocial).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Bellucci', 'Affiliation': 'Department of Computational Neuroscience, Max Planck Institute for Biological Cybernetics, 72076, Tübingen, Germany. gabriele.a.bellucci@gmail.com.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Münte', 'Affiliation': 'Department of Neurology, Universitätsklinikum Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Soyoung Q', 'Initials': 'SQ', 'LastName': 'Park', 'Affiliation': 'Department of Psychology I, University of Lübeck, Lübeck, Germany. soyoung.q.park@gmail.com.'}]",Scientific reports,['10.1038/s41598-022-13778-x']
2409,35715871,"Ocular inflammation after agitation of siliconized and silicone oil-free syringes: a randomized, double-blind, controlled clinical trial.","BACKGROUND


Noninfectious endophthalmitis may be misdiagnosed, leading to serious clinical implications. So far, its causative factors remain unknown. Therefore, this study assessed the role of silicone oil and syringe agitation in the development of inflammation after intravitreal injection of aflibercept.
METHODS


A randomized, double-blind, controlled clinical trial included subjects with an indication of intravitreal antiangiogenic therapy prior to vitrectomy for proliferative diabetic retinopathy. Aflibercept was injected 48 h before surgery. The control group received the injection without agitation, while the intervention group was injected with a previously agitated syringe by flicking with either a siliconized or silicone oil-free syringe. The primary endpoint was the presence of anterior chamber reaction (ACR) at 48 h. Aqueous samples were collected and underwent cytometric bead array analysis for quantification of interleukins and chemokines.
RESULTS


Forty-one individuals were included (21 in the agitation group and 20 in the no-agitation group). None of the included eyes showed baseline signs of AC cells, hyperemia or pain complaint, while 10% of control group and 80% of agitation group showed AC cells 48 h after injection of aflibercept with SR syringe. There were no differences in the mean variations of all cytokines and chemokines by agitation status. However, there was a marginally significant increase between the mean variations of IP-10 (p = 0.057) and IL-8 (p = 0.058) in the siliconized one.
CONCLUSION


This clinical trial discloses a potential role of agitation and siliconized syringes in the development of inflammation after an intravitreal injection of aflibercept. These findings have important clinical implications for all healthcare practitioners who perform intravitreal injections.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials, RBR-95ddhp. Registered 12 May 2019, http://www.ensaiosclinicos.gov.br/rg/RBR-95ddhp/.",2022,"However, there was a marginally significant increase between the mean variations of IP-10 (p = 0.057) and IL-8 (p = 0.058) in the siliconized one.
","['Forty-one individuals were included (21 in the agitation group and 20 in the no-agitation group', 'subjects with an indication of intravitreal antiangiogenic therapy prior to vitrectomy for proliferative diabetic retinopathy']","['agitation and siliconized syringes', 'siliconized and silicone oil-free syringes', 'silicone oil and syringe agitation', 'Aflibercept', 'aflibercept', 'injection without agitation, while the intervention group was injected with a previously agitated syringe by flicking with either a siliconized or silicone oil-free syringe']","['mean variations of all cytokines and chemokines by agitation status', 'mean variations of IP-10', 'baseline signs of AC cells, hyperemia or pain complaint', 'Ocular inflammation', 'presence of anterior chamber reaction (ACR', 'IL-8']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720154', 'cui_str': 'Inject'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",41.0,0.40726,"However, there was a marginally significant increase between the mean variations of IP-10 (p = 0.057) and IL-8 (p = 0.058) in the siliconized one.
","[{'ForeName': 'Natasha Ferreira Santos', 'Initials': 'NFS', 'LastName': 'da Cruz', 'Affiliation': 'Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Murilo Ubukata', 'Initials': 'MU', 'LastName': 'Polizelli', 'Affiliation': 'Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Felipe Picanço', 'Initials': 'FP', 'LastName': 'Muralha', 'Affiliation': 'Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Clarice Neuenschwander Lins', 'Initials': 'CNL', 'LastName': 'de Morais', 'Affiliation': 'Department of Virology, Foundation Oswaldo Cruz, Aggeu Magalhães Institute, Recife, PE, Brazil.'}, {'ForeName': 'Octaviano Magalhães Silva', 'Initials': 'OMS', 'LastName': 'Junior', 'Affiliation': 'Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Gustavo Barreto', 'Initials': 'GB', 'LastName': 'Melo', 'Affiliation': 'Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil. gustavobmelo@yahoo.com.br.'}, {'ForeName': 'Michel Eid', 'Initials': 'ME', 'LastName': 'Farah', 'Affiliation': 'Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.'}]",International journal of retina and vitreous,['10.1186/s40942-022-00387-z']
2410,35715856,A prediction model for xerostomia in locoregionally advanced nasopharyngeal carcinoma patients receiving radical radiotherapy.,"BACKGROUND


This study was to evaluate the predictors of xerostomia and Grade 3 xerostomia in locoregionally advanced nasopharyngeal carcinoma (NPC) patients receiving radical radiotherapy and establish prediction models for xerostomia and Grade 3 xerostomia based on the predictors.
METHODS


Totally, 365 patients with locoregionally advanced NPC who underwent radical radiotherapy were randomly divided into the training set (n = 255) and the testing set (n = 110) at a ratio of 7:3. All variables were included in the least absolute shrinkage and selection operator regression to screen out the potential predictors for xerostomia as well as the Grade 3 xerostomia in locoregionally advanced NPC patients receiving radical radiotherapy. The random forest (RF), a decision tree classifier (DTC), and extreme-gradient boosting (XGB) models were constructed. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), area under the curve (AUC) and accuracy were analyzed to evaluate the predictive performance of the models.
RESULTS


In the RF model for predicting xerostomia, the sensitivity was 1.000 (95%CI 1.000-1.000), the PPV was 0.990 (95%CI 0.975-1.000), the NPV was 1.000 (95%CI 1.000-1.000), the AUC was 0.999 (95%CI 0.997-1.000) and the accuracy was 0.992 (95%CI 0.981-1.000) in the training set. The sensitivity was 0.933 (95%CI 0.880-0.985), the PPV was 0.933 (95%CI 0.880-0.985), and the AUC was 0.915 (95%CI 0.860-0.970) in the testing set. Hypertension, age, total radiotherapy dose, dose at 50% of the left parotid volume, mean dose to right parotid gland, mean dose to oral cavity, and course of induction chemotherapy were important variables associated with the risk of xerostomia in locoregionally advanced NPC patients receiving radical radiotherapy. The AUC of DTC model for predicting xerostomia was 0.769 (95%CI 0.666-0.872) in the testing set. The AUC of the XGB model for predicting xerostomia was 0.834 (0.753-0.916) in the testing set. The RF model showed the good predictive ability with the AUC of 0.986 (95%CI 0.972-1.000) in the training set, and 0.766 (95%CI 0.626-0.905) in the testing set for identifying patients who at high risk of Grade 3 xerostomia in those with high risk of xerostomia.
CONCLUSIONS


An RF model for predicting xerostomia in locoregionally advanced NPC patients receiving radical radiotherapy and an RF model for predicting Grade 3 xerostomia in those with high risk of xerostomia showed good predictive ability.",2022,The AUC of the XGB model for predicting xerostomia was 0.834 (0.753-0.916) in the testing set.,"['locoregionally advanced nasopharyngeal carcinoma (NPC) patients receiving', '365 patients with locoregionally advanced NPC who underwent', 'locoregionally advanced NPC patients receiving', 'locoregionally advanced nasopharyngeal carcinoma patients receiving']",['radical radiotherapy'],"['sensitivity', 'sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), area under the curve (AUC) and accuracy']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",365.0,0.119476,The AUC of the XGB model for predicting xerostomia was 0.834 (0.753-0.916) in the testing set.,"[{'ForeName': 'Minying', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Oncology Radiotherapy, Zhongshan City People's Hospital, No.2 Sunwen Middle Road, Shiqi District, Zhongshan City, 528403, Guangdong, China. li13928197276@outlook.com.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology Radiotherapy, Zhongshan City People's Hospital, No.2 Sunwen Middle Road, Shiqi District, Zhongshan City, 528403, Guangdong, China.""}, {'ForeName': 'Yawen', 'Initials': 'Y', 'LastName': 'Zha', 'Affiliation': ""Department of Oncology Radiotherapy, Zhongshan City People's Hospital, No.2 Sunwen Middle Road, Shiqi District, Zhongshan City, 528403, Guangdong, China.""}, {'ForeName': 'Yani', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Oncology Radiotherapy, Zhongshan City People's Hospital, No.2 Sunwen Middle Road, Shiqi District, Zhongshan City, 528403, Guangdong, China.""}, {'ForeName': 'Bingshuang', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': ""Department of Oncology Radiotherapy, Zhongshan City People's Hospital, No.2 Sunwen Middle Road, Shiqi District, Zhongshan City, 528403, Guangdong, China.""}, {'ForeName': 'Siming', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': ""Department of Oncology Radiotherapy, Zhongshan City People's Hospital, No.2 Sunwen Middle Road, Shiqi District, Zhongshan City, 528403, Guangdong, China.""}, {'ForeName': 'Jiaxiong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Oncology Radiotherapy, Zhongshan City People's Hospital, No.2 Sunwen Middle Road, Shiqi District, Zhongshan City, 528403, Guangdong, China.""}]",BMC oral health,['10.1186/s12903-022-02269-0']
2411,35715854,"An exploratory examination of executive functioning as an outcome, moderator, and predictor in outpatient treatment for adults with anorexia nervosa.","OBJECTIVE


People with anorexia nervosa often exhibit inefficiencies in executive functioning (central coherence and set shifting) that may negatively impact on treatment outcomes. It is unclear from previous research whether these inefficiencies can change over treatment. We aimed to (1) investigate whether executive functioning can improve over treatment, (2) determine whether baseline executive functioning moderates treatment outcome, and (3) examine whether baseline executive functioning predicts early change (i.e., increase in body mass index over the first 13 weeks of treatment) or remission.
METHOD


We conducted linear mixed model and logistic regression analyses on data from the Strong Without Anorexia Nervosa trial (Byrne et al. in Psychol Med 47:2823-2833, 2017). This study was a randomised controlled trial of three outpatient treatments for people with anorexia nervosa: Enhanced Cognitive Behavioural Therapy, Maudsley Model Anorexia Nervosa Treatment for Adults, and Specialist Supportive Clinical Management.
RESULTS


While set shifting clearly improved from baseline to end of treatment, the results for central coherence were less clear cut. People with low baseline central coherence had more rapid reductions in eating disorder psychopathology and clinical impairment than those with high baseline central coherence. Baseline executive functioning did not predict early change or remission.
DISCUSSION


The detail-focused thinking style commonly observed among people with anorexia nervosa may aid treatment outcomes. Future research that is more adequately powered should replicate this study and examine whether the same pattern of results is observed among people with non-underweight eating disorders.",2022,"This study was a randomised controlled trial of three outpatient treatments for people with anorexia nervosa: Enhanced Cognitive Behavioural Therapy, Maudsley Model Anorexia Nervosa Treatment for Adults, and Specialist Supportive Clinical Management.
","['people with anorexia nervosa', 'people with non-underweight eating disorders', ' Maudsley Model Anorexia Nervosa Treatment for Adults, and Specialist Supportive Clinical Management', 'People with anorexia nervosa', 'adults with anorexia nervosa']",['Cognitive Behavioural Therapy'],"['Baseline executive functioning', 'body mass index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.15012,"This study was a randomised controlled trial of three outpatient treatments for people with anorexia nervosa: Enhanced Cognitive Behavioural Therapy, Maudsley Model Anorexia Nervosa Treatment for Adults, and Specialist Supportive Clinical Management.
","[{'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Keegan', 'Affiliation': 'Discipline of Psychology, Blackbird Initiative, Órama Research Institute, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia. ella.keegan@flinders.edu.au.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'SWAN Centre, Perth and School of Psychology, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Hay', 'Affiliation': 'Translational Health Research Institute, School of Medicine, Western Sydney University, Penrith, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Touyz', 'Affiliation': 'InsideOut Institute, Sydney University, Sydney, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': 'Department of Psychological Medicine, Kings College London, London, UK.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychological Medicine, Kings College London, London, UK.'}, {'ForeName': 'Virginia V W', 'Initials': 'VVW', 'LastName': 'McIntosh', 'Affiliation': 'School of Psychology, Speech and Hearing, University of Canterbury Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Tracey D', 'Initials': 'TD', 'LastName': 'Wade', 'Affiliation': 'Discipline of Psychology, Blackbird Initiative, Órama Research Institute, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia.'}]",Journal of eating disorders,['10.1186/s40337-022-00602-0']
2412,35715806,Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial.,"BACKGROUND


In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Given the study's approach, there was no central coordinating center or data monitoring committee for the study, so a site performance self-monitoring toolkit was developed and implemented to support study teams in collecting and maintaining high-quality regulatory information, and consistent review of study data and documentation.
METHODS


The site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality. The toolkit included: (1) a binder of essential study management documents and related monitoring logs for sites to complete and maintain (herein called regulator binder), (2) a study start-up checklist, (3) a self-assessment study conduct and oversight checklist to be completed regularly, and (4) a study close-out checklist. In addition, a process of regular virtual meetings to discuss documentation progress coupled with periodic external remote review of completed logs and checklists provided accountability checks.
RESULTS


Over the course of the study, the sites in China and South Korea completed the entirety of the site performance self-monitoring toolkit, and successfully submitted their completed materials for review. The process of implementing a self-monitoring toolkit in a multinational integrative medicine study is described qualitatively. Periodic external review of the completed toolkit materials revealed categories of findings. Written follow-up reports were provided to sites and discussion of the documents occurred via separate virtual meetings.
CONCLUSIONS


Site study team self-monitoring provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities in higher risk studies. Iterative feedback and support appeared to drive a disciplined approach to maintaining regulatory document compliance and helped sustain investigator and study team engagement in the process.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03783546 (21/12/2018).",2022,The site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality.,"['hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy', 'In 2019, investigators from China, South Korea and the United States of America']",['acupuncture'],[],"[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002454', 'cui_str': 'America'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],3.0,0.104025,The site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality.,"[{'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Baedorf Kassis', 'Affiliation': ""Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA.""}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'White', 'Affiliation': ""Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA.""}, {'ForeName': 'Im Hee', 'Initials': 'IH', 'LastName': 'Shin', 'Affiliation': 'Department of Medical Statistics & Informatics, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Young Ju', 'Initials': 'YJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Department of Oncology, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ligibel', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Bierer', 'Affiliation': ""Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA. bbierer@bwh.harvard.edu.""}]",BMC complementary medicine and therapies,['10.1186/s12906-022-03648-4']
2413,35715757,Loudness affects motion: asymmetric volume of auditory feedback results in asymmetric gait in healthy young adults.,"BACKGROUND


The potential of auditory feedback for motor learning in the rehabilitation of various diseases has become apparent in recent years. However, since the volume of auditory feedback has played a minor role so far and its influence has hardly been considered, we investigate the volume effect of auditory feedback on gait pattern and gait direction and its interaction with pitch.
METHODS


Thirty-two healthy young participants were randomly divided into two groups: Group 1 (n = 16) received a high pitch (150-250 Hz) auditory feedback; group 2 (n = 16) received a lower pitch (95-112 Hz) auditory feedback. The feedback consisted of a real-time sonification of the right and left foot ground contact. After an initial condition (no auditory feedback and full vision), both groups realized a 30-minute habituation period followed by a 30-minute asymmetry period. At any condition, the participants were asked to walk blindfolded and with auditory feedback towards a target at 15 m distance and were stopped 5 m before the target. Three different volume conditions were applied in random order during the habituation period: loud, normal, and quiet. In the subsequent asymmetry period, the three volume conditions baseline, right quiet and left quiet were applied in random order.
RESULTS


In the habituation phase, the step width from the loud to the quiet condition showed a significant interaction of volume*pitch with a decrease at high pitch (group 1) and an increase at lower pitch (group 2) (group 1: loud 1.02 ± 0.310, quiet 0.98 ± 0.301; group 2: loud 0.95 ± 0.229, quiet 1.11 ± 0.298). In the asymmetry period, a significantly increased ground contact time on the side with reduced volume could be found (right quiet: left foot 0.988 ± 0.033, right foot 1.003 ± 0.040, left quiet: left foot 1.004 ± 0.036, right foot 1.002 ± 0.033).
CONCLUSIONS


Our results suggest that modifying the volume of auditory feedback can be an effective way to improve gait symmetry. This could facilitate gait therapy and rehabilitation of hemiparetic and arthroplasty patients, in particular if gait improvement based on verbal corrections and conscious motor control is limited.",2022,"In the asymmetry period, a significantly increased ground contact time on the side with reduced volume could be found (right quiet: left foot 0.988 ± 0.033, right foot 1.003 ± 0.040, left quiet: left foot 1.004 ± 0.036, right foot 1.002 ± 0.033).
","['Thirty-two healthy young participants', 'healthy young adults']","['high pitch (150-250\u2009Hz) auditory feedback; group 2 (n\xa0=\u200916) received a lower pitch (95-112\u2009Hz) auditory feedback', 'initial condition (no auditory feedback and full vision']","['right quiet and left quiet', 'ground contact time', 'gait symmetry']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0241703', 'cui_str': 'High pitched voice'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]",32.0,0.00499208,"In the asymmetry period, a significantly increased ground contact time on the side with reduced volume could be found (right quiet: left foot 0.988 ± 0.033, right foot 1.003 ± 0.040, left quiet: left foot 1.004 ± 0.036, right foot 1.002 ± 0.033).
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Reh', 'Affiliation': 'Institute of Sports Science, Leibniz University Hannover, Am Moritzwinkel 6, 30167, Hannover, Germany. juliareh@gmx.de.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Schmitz', 'Affiliation': 'Institute of Sports Science, Leibniz University Hannover, Am Moritzwinkel 6, 30167, Hannover, Germany.'}, {'ForeName': 'Tong-Hun', 'Initials': 'TH', 'LastName': 'Hwang', 'Affiliation': 'Institute of Sports Science, Leibniz University Hannover, Am Moritzwinkel 6, 30167, Hannover, Germany.'}, {'ForeName': 'Alfred O', 'Initials': 'AO', 'LastName': 'Effenberg', 'Affiliation': 'Institute of Sports Science, Leibniz University Hannover, Am Moritzwinkel 6, 30167, Hannover, Germany. effenberg@sportwiss.uni-hannover.de.'}]",BMC musculoskeletal disorders,['10.1186/s12891-022-05503-6']
2414,35715742,The effect of structured medication review followed by face-to-face feedback to prescribers on adverse drug events recognition and prevention in older inpatients - a multicenter interrupted time series study.,"BACKGROUND


The effectiveness of interventions to improve medication safety in older inpatients is unclear, given a paucity of properly designed intervention studies applying clinically relevant endpoints such as hospital-acquired preventable Adverse Drug Events (pADEs) and unrecognized Adverse Drug Events (uADEs). Therefore, we conducted a quality improvement study and used hospital-acquired pADEs and uADEs as main outcomes to assess the effect of an intervention aimed to improve medication safety in older inpatients.
METHOD


The study followed an interrupted time series design and consisted of three equally spaced sampling points during baseline and during intervention measurements. Each sampling point included between 80 to 90 patients. A total of 500 inpatients ≥65 years and admitted to internal medicine wards of three Dutch hospitals were included. An expert team retrospectively identified and assessed ADEs via a structured patient chart review. The findings from baseline measurement and meetings with the internal medicine and hospital pharmacy staff were used to design the intervention. The intervention consisted of a structured medication review by hospital pharmacists, followed by face-to-face feedback to prescribers, on average 3 days per week.
RESULTS


The rate of hospital-acquired pADEs per 100 hospitalizations was reduced by 50.6% (difference 16.8, 95% confidence interval (CI): 9.0 to 24.6, P <  0.001), serious hospital-acquired pADEs by 62.7% (difference 12.8, 95% CI: 6.4 to 19.2, P <  0.001), and uADEs by 51.8% (difference 11.2, 95% CI: 4.4 to 18.0, P <  0.001). Additional analyses confirmed the robustness of the intervention effect, but residual bias cannot be excluded.
CONCLUSIONS


The intervention significantly decreased the overall and serious hospital-acquired pADE occurrence in older inpatients, and significantly improved overall ADE recognition by prescribers.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number Register, trial registration number: ISRCTN64974377 , registration date (date assigned): 07/02/2011.",2022,"The intervention significantly decreased the overall and serious hospital-acquired pADE occurrence in older inpatients, and significantly improved overall ADE recognition by prescribers.
","['500 inpatients ≥65\u2009years and admitted to internal medicine wards of three Dutch hospitals were included', 'older inpatients ', 'older inpatients']",[],"['overall and serious hospital-acquired pADE occurrence', 'uADEs', 'medication safety', 'overall ADE recognition', 'serious hospital-acquired pADEs', 'rate of hospital-acquired pADEs per 100 hospitalizations']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456393', 'cui_str': 'Hospital acquired'}, {'cui': 'C0057527', 'cui_str': 'desethylprocainamide'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0057163', 'cui_str': 'DAV regimen'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1547273', 'cui_str': 'Preventable'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",500.0,0.133366,"The intervention significantly decreased the overall and serious hospital-acquired pADE occurrence in older inpatients, and significantly improved overall ADE recognition by prescribers.
","[{'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': 'Klopotowska', 'Affiliation': 'Amsterdam University Medical Centers location University of Amsterdam, Medical Informatics, Amsterdam, The Netherlands. j.e.klopotowska@amsterdamumc.nl.'}, {'ForeName': 'Paul F M', 'Initials': 'PFM', 'LastName': 'Kuks', 'Affiliation': 'Amsterdam University Medical Centers location University of Amsterdam, Pharmacy and Clinical Pharmacology, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Wierenga', 'Affiliation': 'Gelderse Vallei Hospital, Hospital Pharmacy, Ede, The Netherlands.'}, {'ForeName': 'Clementine C M', 'Initials': 'CCM', 'LastName': 'Stuijt', 'Affiliation': ""Center of Excellence on Parkinson's disease (Punt voor Parkinson), Groningen, The Netherlands.""}, {'ForeName': 'Lambertus', 'Initials': 'L', 'LastName': 'Arisz', 'Affiliation': 'Amsterdam University Medical Centers location University of Amsterdam, Internal Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Amsterdam University Medical Centers location University of Amsterdam, Epidemiology and Data Science, Amsterdam, The Netherlands.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'de Keizer', 'Affiliation': 'Amsterdam University Medical Centers location University of Amsterdam, Medical Informatics, Amsterdam, The Netherlands.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Smorenburg', 'Affiliation': 'Amsterdam University Medical Centers location University of Amsterdam, Internal Medicine, Amsterdam, The Netherlands.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'de Rooij', 'Affiliation': 'Amstelland Hospital, Board of Directors, Amstelveen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC geriatrics,['10.1186/s12877-022-03118-z']
2415,35715740,Evidence-based Shared-Decision-Making Assistant (SDM-assistant) for choosing antipsychotics: protocol of a cluster-randomized trial in hospitalized patients with schizophrenia.,"BACKGROUND


Choosing an antipsychotic medication is an important medical decision in the treatment of schizophrenia. This decision requires risk-benefit assessments of antipsychotics, and thus, shared-decision making between physician and patients is strongly encouraged. Although the efficacy and side-effect profiles of antipsychotics are well-established, there is no clear framework for the communication of the evidence between physicians and patients. For this reason, we developed an evidence-based shared-decision making assistant (SDM-assistant) that presents high-quality evidence from network meta-analysis on the efficacy and side-effect profile of antipsychotics and can be used as a basis for shared-decision making between physicians and patients when selecting antipsychotic medications.
METHODS


The planned matched-pair cluster-randomised trial will be conducted in acute psychiatric wards (n = 14 wards planned) and will include adult inpatients with schizophrenia or schizophrenia-like disorders (N = 252 participants planned). On the intervention wards, patients and their treating physicians will use the SDM-assistant, whenever a decision on choosing an antipsychotic is warranted. On the control wards, antipsychotics will be chosen according to treatment-as-usual. The primary outcome will be patients' perceived involvement in the decision-making during the inpatient stay as measured with the SDM-Q-9. We will also assess therapeutic alliance, symptom severity, side-effects, treatment satisfaction, adherence, quality of life, functioning and rehospitalizations as secondary outcomes. Outcomes could be analysed at discharge and at follow-up after three months from discharge. The analysis will be conducted per-protocol using mixed-effects linear regression models for continuous outcomes and logistic regression models using generalised estimating equations for dichotomous outcomes. Barriers and facilitators in the implementation of the intervention will also be examined using a qualitative content analysis.
DISCUSSION


This is the first trial to examine a decision assistant specifically designed to facilitate shared-decision making for choosing antipsychotic medications, i.e., SDM-assistant, in acutely ill inpatients with schizophrenia. If the intervention can be successfully implemented, SDM-assistant could advance evidence-based medicine in schizophrenia by putting medical evidence on antipsychotics into the context of patient preferences and values. This could subsequently lead to a higher involvement of the patients in decision-making and better therapy decisions.
TRIAL REGISTRATION


German Clinical Trials Register (ID: DRKS00027316 , registration date 26.01.2022).",2022,"For this reason, we developed an evidence-based shared-decision making assistant (SDM-assistant) that presents high-quality evidence from network meta-analysis on the efficacy and side-effect profile of antipsychotics and can be used as a basis for shared-decision making between physicians and patients when selecting antipsychotic medications.
","['acutely ill inpatients with schizophrenia', 'acute psychiatric wards (n\u2009=\u200914 wards planned) and will include adult inpatients with schizophrenia or schizophrenia-like disorders (N\u2009=\u2009252 participants planned', 'hospitalized patients with schizophrenia']",['Evidence-based Shared-Decision-Making Assistant (SDM-assistant'],"[""patients' perceived involvement in the decision-making during the inpatient stay as measured with the SDM-Q-9"", 'therapeutic alliance, symptom severity, side-effects, treatment satisfaction, adherence, quality of life, functioning and rehospitalizations']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0643808', 'cui_str': 'SDM'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",252.0,0.0882419,"For this reason, we developed an evidence-based shared-decision making assistant (SDM-assistant) that presents high-quality evidence from network meta-analysis on the efficacy and side-effect profile of antipsychotics and can be used as a basis for shared-decision making between physicians and patients when selecting antipsychotic medications.
","[{'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Siafis', 'Affiliation': 'Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich, Munich, Germany. spyridon.siafis@tum.de.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bursch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Müller', 'Affiliation': 'kbo-Isar-Amper-Klinik, Munich, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Schmid', 'Affiliation': 'Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schuster', 'Affiliation': 'Schön Klinik Roseneck, Rosenheim, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Waibel', 'Affiliation': 'Department of Informatics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Huynh', 'Affiliation': 'Department of Informatics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Matthes', 'Affiliation': 'Department of Informatics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rodolico', 'Affiliation': 'Department of Clinical and Experimental Medicine, Institute of Psychiatry, University of Catania, Catania, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brieger', 'Affiliation': 'kbo-Isar-Amper-Klinik, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bühner', 'Affiliation': 'Psychological Methodology and Diagnostics, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Heres', 'Affiliation': 'kbo-Isar-Amper-Klinik, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Leucht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hamann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich, Munich, Germany.'}]",BMC psychiatry,['10.1186/s12888-022-04036-5']
2416,35715681,Effect of dose splitting of a low-volume bowel preparation macrogol-based solution on CT colonography tagging quality.,"PURPOSE


To compare examination quality and acceptability of three different low-volume bowel preparation regimens differing in scheduling of the oral administration of a Macrogol-based solution, in patients undergoing computed tomographic colonography (CTC). The secondary aim was to compare CTC quality according to anatomical and patient variables (dolichocolon, colonic diverticulosis, functional and secondary constipation).
METHODS


One-hundred-eighty patients were randomized into one of three regimens where PEG was administered, respectively: in a single dose the day prior to (A), or in a fractionated dose 2 (B) and 3 days (C) before the examination. Two experienced radiologists evaluated fecal tagging (FT) density and homogeneity both qualitatively and quantitatively by assessing mean segment density (MSD) and relative standard deviation (RSD). Tolerance to the regimens and patient variables were also recorded.
RESULTS


Compared to B and C, regimen A showed a lower percentage of segments with inadequate FT and a significantly higher median FT density and/or homogeneity scores as well as significantly higher MSD values in some colonic segments. No statistically significant differences were found in tolerance of the preparations. A higher number of inadequate segments were observed in patients with dolichocolon (p < 0.01) and secondary constipation (p < 0.01). Interobserver agreement was high for the assessment of both FT density (k = 0.887) and homogeneity (k = 0.852).
CONCLUSION


The best examination quality was obtained when PEG was administered the day before CTC in a single session. The presence of dolichocolon and secondary constipation represent a risk factor for the presence of inadequately tagged colonic segments.",2022,"Compared to B and C, regimen A showed a lower percentage of segments with inadequate FT and a significantly higher median FT density and/or homogeneity scores as well as significantly higher MSD values in some colonic segments.","['patients undergoing computed tomographic colonography (CTC', 'One-hundred-eighty patients']","['PEG', 'low-volume bowel preparation macrogol-based solution']","['tolerance', 'secondary constipation', 'FT density', 'number of inadequate segments', 'examination quality', 'radiologists evaluated fecal tagging (FT) density and homogeneity both qualitatively and quantitatively by assessing mean segment density (MSD) and relative standard deviation (RSD', 'CT colonography tagging quality', 'CTC quality according to anatomical and patient variables (dolichocolon, colonic diverticulosis, functional and secondary constipation', 'median FT density and/or homogeneity scores', 'examination quality and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0935912', 'cui_str': 'Computed Tomographic Colonography'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0935912', 'cui_str': 'Computed Tomographic Colonography'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0266198', 'cui_str': 'Dolichocolon'}, {'cui': 'C0012819', 'cui_str': 'Diverticular disease of colon'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",180.0,0.0236107,"Compared to B and C, regimen A showed a lower percentage of segments with inadequate FT and a significantly higher median FT density and/or homogeneity scores as well as significantly higher MSD values in some colonic segments.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mistretta', 'Affiliation': 'Department of Surgical Sciences, University of Turin, Turin, Italy. francescomistretta93@gmail.com.'}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Damiani', 'Affiliation': 'Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Campanella', 'Affiliation': 'Radiology Unit, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Mazzetti', 'Affiliation': 'Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Gulino', 'Affiliation': 'Radiology Unit, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cappello', 'Affiliation': 'Radiology Unit, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Regge', 'Affiliation': 'Department of Surgical Sciences, University of Turin, Turin, Italy.'}]",La Radiologia medica,['10.1007/s11547-022-01514-4']
2417,35715930,Description of a European memory clinic cohort undergoing amyloid-PET: The AMYPAD Diagnostic and Patient Management Study.,"INTRODUCTION


AMYPAD Diagnostic and Patient Management Study (DPMS) aims to investigate the clinical utility and cost-effectiveness of amyloid-PET in Europe. Here we present participants' baseline features and discuss the representativeness of the cohort.
METHODS


Participants with subjective cognitive decline plus (SCD+), mild cognitive impairment (MCI), or dementia were recruited in eight European memory clinics from April 16, 2018, to October 30, 2020, and randomized into three arms: ARM1, early amyloid-PET; ARM2, late amyloid-PET; and ARM3, free-choice.
RESULTS


A total of 840 participants (244 SCD+, 341 MCI, and 255 dementia) were enrolled. Sociodemographic/clinical features did not differ significantly among recruiting memory clinics or with previously reported cohorts. The randomization assigned 35% of participants to ARM1, 32% to ARM2, and 33% to ARM3; cognitive stages were distributed equally across the arms.
DISCUSSION


The features of AMYPAD-DPMS participants are as expected for a memory clinic population. This ensures the generalizability of future study results.",2022,"The randomization assigned 35% of participants to ARM1, 32% to ARM2, and 33% to ARM3; cognitive stages were distributed equally across the arms.
","['European memory clinic cohort undergoing amyloid-PET', '840 participants (244 SCD+, 341 MCI, and 255 dementia) were enrolled', 'Europe', 'Participants with subjective cognitive decline plus (SCD+), mild cognitive impairment (MCI), or dementia were recruited in eight European memory clinics from April 16, 2018, to October 30, 2020']",['amyloid-PET'],[],"[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]",[],840.0,0.215659,"The randomization assigned 35% of participants to ARM1, 32% to ARM2, and 33% to ARM3; cognitive stages were distributed equally across the arms.
","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Altomare', 'Affiliation': 'Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Lyduine', 'Initials': 'L', 'LastName': 'Collij', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers (UMC) - Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Caprioglio', 'Affiliation': 'Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Scheltens', 'Affiliation': 'Alzheimer Center, Department of Neurology, Amsterdam University Medical Centers (UMC) - Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Bart N M', 'Initials': 'BNM', 'LastName': 'van Berckel', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers (UMC) - Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Isadora Lopes', 'Initials': 'IL', 'LastName': 'Alves', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers (UMC) - Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Berkhof', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam University Medical Centers (UMC) - Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'de Gier', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers (UMC) - Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Garibotto', 'Affiliation': 'Laboratory of Neuroimaging and Innovative Molecular Tracers (NIMTlab), Geneva University Neurocenter and Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Moro', 'Affiliation': 'Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Poitrine', 'Affiliation': 'Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Delrieu', 'Affiliation': 'Gérontopôle, Department of Geriatrics, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Payoux', 'Affiliation': 'Department of Nuclear Medicine, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Saint-Aubert', 'Affiliation': 'Department of Nuclear Medicine, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Molinuevo', 'Affiliation': 'Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Grau-Rivera', 'Affiliation': 'Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.'}, {'ForeName': 'Juan-Domingo', 'Initials': 'JD', 'LastName': 'Gispert', 'Affiliation': 'Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Minguillón', 'Affiliation': 'Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Fauria', 'Affiliation': 'Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.'}, {'ForeName': 'Marta Felez', 'Initials': 'MF', 'LastName': 'Sanchez', 'Affiliation': 'Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Rădoi', 'Affiliation': 'Barcelonaβeta Brain Research Center (BBRC), Pasqual Maragall Foundation, Barcelona, Spain.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Drzezga', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jessen', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Escher', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Zeyen', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Nordberg', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Center of Alzheimer Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Savitcheva', 'Affiliation': 'Medical Radiation Physics and Nuclear Medicine, Section for Nuclear Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Jelic', 'Affiliation': 'Cognitive Disorders Clinic, Theme Inflammation and Aging, Karolinska University Hospital-Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Walker', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Ho-Yun', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': ""St. Margaret's Hospital, Essex Partnership University NHS Foundation Trust, Essex, UK.""}, {'ForeName': 'Lean', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Demonet', 'Affiliation': 'Leenaards Memory Center, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Plaza Wuthrich', 'Affiliation': 'Leenaards Memory Center, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Gismondi', 'Affiliation': 'Life Molecular Imaging, Berlin, Germany.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Farrar', 'Affiliation': 'GE Healthcare, Amersham, UK.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers (UMC) - Location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Stephens', 'Affiliation': 'Life Molecular Imaging, Berlin, Germany.'}, {'ForeName': 'Giovanni B', 'Initials': 'GB', 'LastName': 'Frisoni', 'Affiliation': 'Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12696']
2418,35716331,Prevention of Polymorphic Light Eruption Afforded by a Very High Broad-Spectrum Protection Sunscreen Containing Ectoin.,"INTRODUCTION


Polymorphic light eruption (PLE) is the most common idiopathic, acquired photodermatosis. The pathophysiology of PLE is not yet fully understood but seems to involve immunological mechanisms, UVA-induced oxidative stress, and the subsequent elicitation of a cellular stress response affecting keratinocyte gene expression and skin immune function. In the present study, a high broad-spectrum sunscreen medical device (MD), containing a very high protection complex of UVB and UVA filters and ectoin, was investigated for its ability to protect against UVA-induced PLE.
METHODS


The study was carried out as a monocentric, double-blinded, randomized, untreated controlled design. The test MD was applied (2 mg/cm 2 ) on one side of the chest according to a randomization list of 15 patients with a typical history of PLE, and the contralateral area remained untreated. After product application, the test areas were exposed daily to increasing doses of UVA radiation (from 40 to 60 J/cm 2 ) until a PLE reaction was detected or for a maximum of five consecutive days. Evaluations of induced PLE included clinical scoring and chromametry for erythema and pigmentation.
RESULTS


Overall, no positive PLE reaction was observed on the side of the chest treated by the test MD, whereas positive PLE reactions were triggered on the untreated side of 13 subjects. Subjective sensations were very rare on the MD-treated side but were numerous and more severe on the untreated side. Chromametry and clinical visual inspection indicated that the skin color was unchanged on the MD-protected side, whereas high increased values of erythema and pigmentation were observed on the untreated chest side.
CONCLUSION


This MD sunscreen based on a complex of UVA-UVB filters and 1% of ectoin may be effective in preventing UVA-induced PLE. New studies comparing this MD sunscreen versus the same product without ectoin should be conducted.
CLINICALTRIALS


gov identifier: NCT05320315 (retrospectively registered 09/17/2021).",2022,"Overall, no positive PLE reaction was observed on the side of the chest treated by the test MD, whereas positive PLE reactions were triggered on the untreated side of 13 subjects.",[],"['MD sunscreen', 'UVA radiation']","['clinical scoring and chromametry for erythema and pigmentation', 'Subjective sensations', 'skin color', 'positive PLE reactions', 'values of erythema and pigmentation', 'positive PLE reaction', 'Chromametry and clinical visual inspection']",[],"[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0564460', 'cui_str': 'UVA - Ultraviolet A radiation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031736', 'cui_str': 'Polymorphous light eruption'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}]",15.0,0.0262555,"Overall, no positive PLE reaction was observed on the side of the chest treated by the test MD, whereas positive PLE reactions were triggered on the untreated side of 13 subjects.","[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Duteil', 'Affiliation': ""CPCAD, Hôpital l'Archet 2, Nice, France. luc.duteil@skinpharma.fr.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Queille-Roussel', 'Affiliation': ""CPCAD, Hôpital l'Archet 2, Nice, France.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Aladren', 'Affiliation': 'Innovation and Development, ISDIN, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Bustos', 'Affiliation': 'Innovation and Development, ISDIN, Barcelona, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Trullas', 'Affiliation': 'Innovation and Development, ISDIN, Barcelona, Spain.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Granger', 'Affiliation': 'Innovation and Development, ISDIN, Barcelona, Spain.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Krutmann', 'Affiliation': 'IUF Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Department of Dermatology, CHU Nice, University Côte d'Azur, Nice, France.""}]",Dermatology and therapy,['10.1007/s13555-022-00755-5']
2419,35716319,"Efficacy and Safety of the Long-Acting Diquafosol Ophthalmic Solution DE-089C in Patients with Dry Eye: A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study.","INTRODUCTION


DE-089C is a newly developed long-acting formulation of diquafosol ophthalmic solution with less frequent administration (three times daily) than the currently approved and clinically used diquafosol ophthalmic solution (six times daily), hereinafter referred to as DQS. DE-089C is desirable for achieving better patient adherence in clinical practice for dry eye therapy. The objective of this study was to confirm the efficacy and safety of DE-089C in patients with dry eye compared to placebo.
METHODS


This randomized, multicenter, double-masked, placebo-controlled, parallel-group phase 3 study was conducted in Japan. Patients with aqueous-deficient dry eye satisfying Schirmer's test I results ≤ 5 mm/5 min were included. A total of 337 patients with dry eye were randomized in an equal ratio to treatment with DE-089C or placebo ophthalmic solution, three times daily for 4 weeks. The primary endpoint for efficacy was change in fluorescein corneal staining score from baseline to week 4. The incidence of adverse drug reactions was investigated for safety evaluation.
RESULTS


The background characteristics of patients in the two groups were similar. Primary endpoint of change in fluorescein corneal staining score at week 4 in the DE-089C group was significantly improved compared with the placebo group (least squares mean difference - 0.51, 95% CI - 0.754 to - 0.269, P < 0.0001). The secondary endpoint of the Lissamine green conjunctival staining score was also significantly improved in the DE-089C group compared to that in the placebo group, while other secondary endpoints were not achieved in this study. Commonly (incidence ≥ 1%) reported adverse drug reactions in the DE-089C group were eye irritation (3.6%) and eye discharge (1.8%) with mild severity, and the incidences of these two events were not higher than those in previous clinical studies on DQS.
CONCLUSION


The efficacy and safety of DE-089C administered three times daily at half the dosage of DQS in patients with dry eye were confirmed in this study.
TRIAL REGISTRATION


Japan Pharmaceutical Information Center ID, JapicCTI-205177.",2022,"mean difference - 0.51, 95% CI - 0.754 to - 0.269, P < 0.0001).","['337 patients with dry eye', 'Patients with Dry Eye', 'patients with dry eye', 'parallel-group phase\xa03 study was conducted in Japan', ""Patients with aqueous-deficient dry eye satisfying Schirmer's test""]","['DQS', 'Long-Acting Diquafosol Ophthalmic Solution', 'DE-089C', 'DE-089C or placebo ophthalmic solution', 'placebo', 'Placebo']","['efficacy and safety', 'Lissamine green conjunctival staining score', 'fluorescein corneal staining score', 'Efficacy and Safety', 'eye discharge', 'eye irritation', 'change in fluorescein corneal staining score', 'adverse drug reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1955479', 'cui_str': 'diquafosol'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0423006', 'cui_str': 'Discharge from eye'}, {'cui': 'C0235266', 'cui_str': 'Eye irritation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",337.0,0.387127,"mean difference - 0.51, 95% CI - 0.754 to - 0.269, P < 0.0001).","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Hori', 'Affiliation': 'Department of Ophthalmology, Toho University Omori Medical Center, Toho University Graduate School of Medicine, 6-11-1, Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan. yhori@med.toho-u.ac.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Oka', 'Affiliation': 'Global Clinical Development and Operations, Product Development Division, Clinical Operations Japan/Asia, Santen Pharmaceutical Co., Ltd., Kita-ku, Ofukacho Osaka, Japan.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Inai', 'Affiliation': 'Global Clinical Development and Operations, Product Development Division, Clinical Operations Japan/Asia, Santen Pharmaceutical Co., Ltd., Kita-ku, Ofukacho Osaka, Japan.'}]",Advances in therapy,['10.1007/s12325-022-02194-2']
2420,35716317,Do preferences differ based on respondent experience of a health issue and its treatment? A case study using a public health intervention.,"OBJECTIVES


Preference information is increasingly being elicited to support decision-making. Although discrete choice experiments (DCEs) are commonly used, little is known about how respondents' relative experience of a health issue, and its treatment, might impact the results of preference studies. The aim of this study was to explore how preferences differ between groups of individuals with varying levels of experience of a health issue and its treatment, using a weight loss maintenance (WLM) programme as a case study.
METHODS


An online DCE survey was provided to four groups, each differing in their level of experience with weight loss and WLM programmes. One group was recruited from a randomised controlled trial of a WLM programme (ISRCTN14657176) and the other three from an online panel. Choice data were analysed using mixed logit models. Relative attribute importance scores and willingness-to-pay (WTP) estimates were estimated to enable comparisons between groups.
RESULTS


Preferences differed between the groups across different attributes. The largest differences related to the outcome (weight re-gain) and cost attributes, resulting in WTP estimates that were statistically significantly different. The most experienced group was willing to pay £0.35 (95% CI: £0.28, £0.42) to avoid a percentage point increase in weight re-gain, compared with £0.12 (95% CI: £0.08, £0.16) for the least experienced group.
CONCLUSION


This study provides evidence in a public health setting to suggest that preferences differ based on respondent experience of the health issue and its treatment. Health preference researchers should therefore carefully consider the appropriate composition of their study samples.",2022,"The most experienced group was willing to pay £0.35 (95% CI: £0.28, £0.42) to avoid a percentage point increase in weight re-gain, compared with £0.12 (95% CI: £0.08, £0.16) for the least experienced group.
",[],"['public health intervention', 'WLM programme', 'weight loss maintenance (WLM) programme']","['outcome (weight re-gain) and cost attributes, resulting in WTP estimates', 'weight re-gain', 'Relative attribute importance scores and willingness-to-pay (WTP) estimates']",[],"[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.049022,"The most experienced group was willing to pay £0.35 (95% CI: £0.28, £0.42) to avoid a percentage point increase in weight re-gain, compared with £0.12 (95% CI: £0.08, £0.16) for the least experienced group.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mott', 'Affiliation': 'Office of Health Economics, Southside 7th Floor, 105 Victoria Street, London, UK. dmott@ohe.org.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ternent', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-022-01482-6']
2421,35716457,"Pentoxifylline significantly reduces radicular pain secondary to lumbar disc hernia: A prospective, randomized crossover, single-blind controlled pilot study.","BACKGROUND AND OBJECTIVES


Optimal medical treatment for low back pain, sometimes associated to radicular pain, has yet to be established. Herniated nucleus pulposus has been found to release TNFα, a pro-inflammatory cytokine involved in radiculopathy. Interestingly, Pentoxifylline (PTX), a phosphodiesterase inhibitor, blocks the activity of TNFα. The aim of this study is to assess the effectiveness of PTX when added to the treatment protocol of radiculopathy in lumbar disc herniation.
METHODS


Fifty-eight patients with radicular pain secondary to a lumbar disc hernia were included in this prospective, randomized crossover, single-blind controlled study. PTX was added randomly to the same treatment protocol (ibuprofen + paracetamol + pregabalin) either during the first or the second 15 days of treatment. Patients' pain was assessed at day 15 via the Numeric Rating Scale (NRS) and the Patient's Global Impression of Change score (PGIC). D15 NRS value was considered as the primary outcome measure.
RESULTS


Mean D15 NRS score was 3.2 ± 0.84 during the 15-days treatment with PTX, and 5,1 ± 0.97 during the 15-days treatment without PTX (p < 0.0001). During the 15 days treatment period with/without PTX, PGIC score was (7) in 19/3 patients, (6) in 30/10 patients, (5) in 7/27 patients and (4) in 2/18 patients respectively, difference being highly significant (p < 0.0000).
CONCLUSION


Adjunction of PTX to the standard medical treatment of radicular pain associated with lumbar disc hernia seems to significantly decrease patients' pain intensity in addition to improving their global satisfaction with treatment.",2022,"During the 15 days treatment period with/without PTX, PGIC score was (7) in 19/3 patients, (6) in 30/10 patients, (5) in 7/27 patients and (4) in 2/18 patients respectively, difference being highly significant (p < 0.0000).
","['Fifty-eight patients with radicular pain secondary to a lumbar disc hernia', 'lumbar disc hernia']","['Pentoxifylline', 'protocol (ibuprofen + paracetamol + pregabalin', 'PTX', 'Pentoxifylline (PTX', 'radiculopathy', 'TNFα']","['PGIC score', 'radicular pain secondary', ""patients' pain intensity"", ""Patients' pain"", 'Mean D15 NRS score', ""Numeric Rating Scale (NRS) and the Patient's Global Impression of Change score (PGIC""]","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",58.0,0.0553792,"During the 15 days treatment period with/without PTX, PGIC score was (7) in 19/3 patients, (6) in 30/10 patients, (5) in 7/27 patients and (4) in 2/18 patients respectively, difference being highly significant (p < 0.0000).
","[{'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Tarabay', 'Affiliation': 'Department of Neurosurgery, Hotel-Dieu de France Hospital & Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Komboz', 'Affiliation': 'Laboratory of Research in Neuroscience, Faculty of Medicine, Pôle Technologie Santé, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kobaïter-Maarrawi', 'Affiliation': 'Laboratory of Research in Neuroscience, Faculty of Medicine, Pôle Technologie Santé, Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Fayad', 'Affiliation': 'Department of Rheumatology, Hotel-Dieu de France Hospital & Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Hicham Abou', 'Initials': 'HA', 'LastName': 'Zeid', 'Affiliation': 'Department of Anaesthesiology, critical care and pain management, Hotel-Dieu de France Hospital & Saint Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maarrawi', 'Affiliation': 'Department of Neurosurgery, Hotel-Dieu de France Hospital & Saint Joseph University, Beirut, Lebanon; Laboratory of Research in Neuroscience, Faculty of Medicine, Pôle Technologie Santé, Saint Joseph University, Beirut, Lebanon. Electronic address: jomaarrawi@hotmail.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2022.107309']
2422,35716932,Low-dose colchicine and high-sensitivity C-reactive protein after myocardial infarction: A combined analysis using individual patient data from the COLCOT and LoDoCo-MI studies.,"BACKGROUND


Low-dose colchicine is effective in reducing the risks of recurrent cardiovascular events following an acute myocardial infarction (MI). However, the influence of colchicine on inflammation remains inconclusive. In the current study, we conducted a pooled analysis using individual patient data from the COLCOT and LoDoCo-MI trials to assess the effect of low-dose colchicine on high-sensitivity C reactive protein (hs-CRP) in patients with acute MI.
METHODS


We performed a combined analysis of individual patient data from two clinical trials (COLCOT, LoDoCo-MI). Paired pre-treatment and post-treatment hs-CRP (mg/L) were available in 222 patients for LoDoCo-MI and 207 patients for COLCOT (n pooled  = 429). We evaluated the effect of colchicine vs. placebo on post-treatment hs-CRP coded continuously and ≤ 1.0 mg/L in adjusted mixed-model multi-level regression analyses.
RESULTS


Colchicine was not significantly associated with post-treatment hs-CRP when it was considered as a continuous variable (beta: -0.41, P = 0.429). However, the intervention was significantly associated with increased odds of achieving post-treatment hs-CRP values ≤1.0 mg/L compared to placebo (odds ratio: 1.64, 95% confidence interval: 1.07 to 2.51, P = 0.024).
CONCLUSIONS


Reduction of inflammation may be a key component in the clinical efficacy of low-dose colchicine with respect to decreased risk of recurrent cardiovascular events following MI. Systematic sampling of hs-CRP before and after treatment with colchicine may be relevant.",2022,"However, the intervention was significantly associated with increased odds of achieving post-treatment hs-CRP values ≤1.0 mg/L compared to placebo (odds ratio: 1.64, 95% confidence interval: 1.07 to 2.51, P = 0.024).
","['after myocardial infarction', 'acute myocardial infarction (MI', 'patients with acute MI']","['colchicine', 'Colchicine', 'colchicine vs. placebo', 'colchicine and high-sensitivity C-reactive protein', 'placebo']",[],"[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",[],,0.193387,"However, the intervention was significantly associated with increased odds of achieving post-treatment hs-CRP values ≤1.0 mg/L compared to placebo (odds ratio: 1.64, 95% confidence interval: 1.07 to 2.51, P = 0.024).
","[{'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada; Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada; Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Canada; Montreal Heart Institute, Montreal, Canada; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hennessy', 'Affiliation': 'Department of Cardiology, Royal Perth Hospital, Perth, Australia and Medical School, University of Western Australia.; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Schultz', 'Affiliation': 'Department of Cardiology, Royal Perth Hospital, Perth, Australia and Medical School, University of Western Australia.; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Barhdadi', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada; Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Canada; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rhainds', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Hillis', 'Affiliation': 'Department of Cardiology, Royal Perth Hospital, Perth, Australia and Medical School, University of Western Australia.; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada. Electronic address: graham.hillis@health.wa.gov.au.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada; Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Canada; Université de Montréal Beaulieu-Saucier Pharmacogenomics Centre, Montreal, Canada. Electronic address: jean-claude.tardif@icm-mhi.org.'}]",International journal of cardiology,['10.1016/j.ijcard.2022.06.028']
2423,35716856,Effect of continuous positive airway pressure therapy on recurrence of atrial fibrillation after pulmonary vein isolation in patients with obstructive sleep apnea: A randomized controlled trial.,"BACKGROUND


Obstructive sleep apnea (OSA) is associated with atrial fibrillation (AF). It is unknown whether treatment with continuous positive airway pressure (CPAP) reduces AF recurrence after catheter ablation with pulmonary vein isolation (PVI).
OBJECTIVE


We aimed to assess the effect of CPAP treatment on the recurrence and burden of AF after PVI in patients with OSA.
METHODS


We randomized patients with paroxysmal AF and an apnea-hypopnea index (AHI) ≥15 events/h to treatment with CPAP or standard care. Heart rhythm was monitored by an implantable loop recorder. AF recurrence after PVI was defined as any episode of AF lasting more than 2 minutes after a 3-month blanking period.
RESULTS


PVI was performed in 83 patients. 37 patients were randomized to CPAP treatment and 46 patients to standard care. The AHI was reduced from 26.7 ± 14 to 1.7 ± 1.3 events/h at follow-up in the CPAP group (P = .001). 57 % of patients in both the CPAP group and the standard care group had at least one episode of AF 3-12 months after PVI (P for difference = 1.00). AF burden after ablation was reduced in both groups, with no between-group difference (P = .69).
CONCLUSION


In patients with paroxysmal AF and OSA, treatment with CPAP did not further reduce the risk of AF recurrence after ablation. PVI considerably reduced the burden of AF in OSA-patients, without any difference between the groups.",2022,"AF burden after ablation was reduced in both groups, with no between-group difference (P = .69).
","['patients with OSA', '37 patients', 'patients with paroxysmal AF and an apnea-hypopnea index (AHI) ≥15 events/h to treatment with CPAP or standard care', 'patients with obstructive sleep apnea', 'Obstructive sleep apnea (OSA', '83 patients']","['continuous positive airway pressure therapy', 'catheter ablation with pulmonary vein isolation (PVI', 'CPAP', 'continuous positive airway pressure (CPAP']","['AF burden after ablation', 'risk of AF recurrence', 'recurrence and burden of AF', 'AF recurrence', 'Heart rhythm', 'burden of AF', 'recurrence of atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}]",83.0,0.039046,"AF burden after ablation was reduced in both groups, with no between-group difference (P = .69).
","[{'ForeName': 'Tove-Elizabeth', 'Initials': 'TE', 'LastName': 'Hunt', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; ProCardio Center for Innovation, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: tovhun@ous-hf.no.'}, {'ForeName': 'Gunn Marit', 'Initials': 'GM', 'LastName': 'Traaen', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; KG Jebsen Center for Cardiac Research, University of Oslo, Norway and Center for Heart Failure Research, Oslo University Hospital, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Aakerøy', 'Affiliation': 'Department of Thoracic Medicine, St. Olavs University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Faculty of Medicine and Health Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bendz', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; KG Jebsen Center for Cardiac Research, University of Oslo, Norway and Center for Heart Failure Research, Oslo University Hospital, Norway.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Øverland', 'Affiliation': 'Lovisenberg Diaconal Hospital, Department of Otorhinolaryngology, Oslo, Norway.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Akre', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Otorhinolaryngology, Oslo, Norway.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Steinshamn', 'Affiliation': 'Department of Thoracic Medicine, St. Olavs University Hospital, Trondheim, Norway; Department of Circulation and Medical Imaging, Faculty of Medicine and Health Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Jan Pål', 'Initials': 'JP', 'LastName': 'Loennechen', 'Affiliation': ""Department of Circulation and Medical Imaging, Faculty of Medicine and Health Science, Norwegian University of Science and Technology, Trondheim, Norway; St. Olav's University Hospital, Department of Cardiology, Trondheim, Norway.""}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Hegbom', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Øyvind H', 'Initials': 'ØH', 'LastName': 'Lie', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; ProCardio Center for Innovation, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lyseggen', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kristina Hermann', 'Initials': 'KH', 'LastName': 'Haugaa', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; ProCardio Center for Innovation, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; KG Jebsen Center for Cardiac Research, University of Oslo, Norway and Center for Heart Failure Research, Oslo University Hospital, Norway.'}, {'ForeName': 'Ole-Gunnar', 'Initials': 'OG', 'LastName': 'Anfinsen', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Department of Cardiology, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Heart rhythm,['10.1016/j.hrthm.2022.06.016']
2424,35716852,The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches.,"BACKGROUND AND AIMS


The aim of this study is to assess the acceptability of following three different fasting protocols [Early Time-restricted Feeding (eTRF; eating majority of kcals before 5pm), Time-restricted Feeding (TRF; restricting feeding window to 8 hrs/d), or Alternate Day Fasting (ADF; complete fasting every other day)].
METHODS


In this remotely delivered six-week crossover intervention, participants were randomly assigned to follow either an eTRF, TRF, or ADF diet for one week, followed by a one-week washout period. Participants followed all three diets and completed questionnaires assessing self-reported weight, energy intake, dietary acceptability (Food Acceptability Questionnaire), and facilitators and barriers to adhering to each diet. Differences in main outcomes (e.g., dietary acceptability and weight loss) were assessed via repeated measures ANOVA.
RESULTS


A total of 32 of participants began the study (mean BMI of 32.6 ± 6.0 kg/m 2 ). There were no differences in kcals or weight loss among the three diets. Dietary acceptability was higher on the TRF diet (54.1 ± 8.2) than the eTRF (50.2 ± 6.6, p = 0.02) or ADF (48.0 ± 7.9, p = 0.004) diets. The majority of participants (71%) indicated the TRF diet was the easiest to follow and 75% said that ADF was the most difficult. Participants cited having a mobile app to track their diet and being provided with menu plans would help facilitate adherence with their diets.
CONCLUSIONS


This study found that acceptability was highest for an TRF diet and lowest for ADF, with no differences in weight loss or change in energy intake among the TRF, ADF, or eTRF groups.
CLINICAL TRIALS



GOV IDENTIFIER


NCT04527952.",2022,There were no differences in kcals or weight loss among the three diets.,['A total of 32 of participants began the study (mean BMI of 32.6\u202f±\u202f6.0\u202fkg/m 2 '],"['fasting protocols [Early Time-restricted Feeding (eTRF; eating majority of kcals before 5pm), Time-restricted Feeding (TRF', 'eTRF, TRF, or ADF diet']","['dietary acceptability and weight loss', 'weight loss', 'kcals or weight loss', 'Dietary acceptability', 'TRF diet', 'questionnaires assessing self-reported weight, energy intake, dietary acceptability (Food Acceptability Questionnaire), and facilitators and barriers to adhering to each diet']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C1509133', 'cui_str': 'post meridiem'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",32.0,0.0383114,There were no differences in kcals or weight loss among the three diets.,"[{'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene St, Columbia, SC, 29208, USA. Electronic address: brie@sc.edu.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'College of Nursing, University of South Carolina, 1601 Greene Street, Columbia, SC, 29208, USA; Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, 915 Greene St, Columbia, SC, 29208, USA. Electronic address: wirthm@email.sc.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Bernhart', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene St, Columbia, SC, 29208, USA. Electronic address: bernhaj@email.sc.edu.'}, {'ForeName': 'Halide', 'Initials': 'H', 'LastName': 'Aydin', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene St, Columbia, SC, 29208, USA. Electronic address: HAYDIN@email.sc.edu.'}]",Appetite,['10.1016/j.appet.2022.106135']
2425,35704292,Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit.,"BACKGROUND


Studies that have evaluated the use of intravenous vitamin C in adults with sepsis who were receiving vasopressor therapy in the intensive care unit (ICU) have shown mixed results with respect to the risk of death and organ dysfunction.
METHODS


In this randomized, placebo-controlled trial, we assigned adults who had been in the ICU for no longer than 24 hours, who had proven or suspected infection as the main diagnosis, and who were receiving a vasopressor to receive an infusion of either vitamin C (at a dose of 50 mg per kilogram of body weight) or matched placebo administered every 6 hours for up to 96 hours. The primary outcome was a composite of death or persistent organ dysfunction (defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy) on day 28.
RESULTS


A total of 872 patients underwent randomization (435 to the vitamin C group and 437 to the control group). The primary outcome occurred in 191 of 429 patients (44.5%) in the vitamin C group and in 167 of 434 patients (38.5%) in the control group (risk ratio, 1.21; 95% confidence interval [CI], 1.04 to 1.40; P = 0.01). At 28 days, death had occurred in 152 of 429 patients (35.4%) in the vitamin C group and in 137 of 434 patients (31.6%) in the placebo group (risk ratio, 1.17; 95% CI, 0.98 to 1.40) and persistent organ dysfunction in 39 of 429 patients (9.1%) and 30 of 434 patients (6.9%), respectively (risk ratio, 1.30; 95% CI, 0.83 to 2.05). Findings were similar in the two groups regarding organ-dysfunction scores, biomarkers, 6-month survival, health-related quality of life, stage 3 acute kidney injury, and hypoglycemic episodes. In the vitamin C group, one patient had a severe hypoglycemic episode and another had a serious anaphylaxis event.
CONCLUSIONS


In adults with sepsis receiving vasopressor therapy in the ICU, those who received intravenous vitamin C had a higher risk of death or persistent organ dysfunction at 28 days than those who received placebo. (Funded by the Lotte and John Hecht Memorial Foundation; LOVIT ClinicalTrials.gov number, NCT03680274.).",2022,"Findings were similar in the two groups regarding organ-dysfunction scores, biomarkers, 6-month survival, health-related quality of life, stage 3 acute kidney injury, and hypoglycemic episodes.","['adults with sepsis who were receiving vasopressor therapy in the intensive care unit (ICU', 'adults with sepsis receiving vasopressor therapy in the ICU', 'Adults with Sepsis in the Intensive Care Unit', 'adults who had been in the ICU for no longer than 24 hours, who had proven or suspected infection as the main diagnosis, and who were receiving a vasopressor to receive an infusion of either', '872 patients underwent randomization (435 to the vitamin C group and 437 to the control group']","['Intravenous Vitamin C', 'intravenous vitamin C', 'placebo', 'vitamin C']","['persistent organ dysfunction', 'composite of death or persistent organ dysfunction (defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy) on day 28', 'organ-dysfunction scores, biomarkers, 6-month survival, health-related quality of life, stage 3 acute kidney injury, and hypoglycemic episodes', 'risk of death or persistent organ dysfunction', 'severe hypoglycemic episode', 'death', 'serious anaphylaxis event']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3494458', 'cui_str': 'Organ Dysfunction Scores'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C4524222', 'cui_str': 'Stage 3 acute kidney injury'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",872.0,0.493025,"Findings were similar in the two groups regarding organ-dysfunction scores, biomarkers, 6-month survival, health-related quality of life, stage 3 acute kidney injury, and hypoglycemic episodes.","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Masse', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Menard', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Battista', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Day', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Guyatt', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Salmaan', 'Initials': 'S', 'LastName': 'Kanji', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Bharath-Kumar', 'Initials': 'BK', 'LastName': 'Tirupakuzhi Vijayaraghavan', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Bolduc', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marinoff', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Millen', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Maureen O', 'Initials': 'MO', 'LastName': 'Meade', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Hand', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Watpool', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Porteous', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': ""D'Aragon"", 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Emilie P', 'Initials': 'EP', 'LastName': 'Belley-Cote', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Carbonneau', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Clarke', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maslove', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Hunt', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Chassé', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Lebrasseur', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lauzier', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Quiroz-Martinez', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Oleksa G', 'Initials': 'OG', 'LastName': 'Rewa', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Charbonney', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Andrew J E', 'Initials': 'AJE', 'LastName': 'Seely', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Demetrios J', 'Initials': 'DJ', 'LastName': 'Kutsogiannis', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'LeBlanc', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Mekontso-Dessap', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Tina S', 'Initials': 'TS', 'LastName': 'Mele', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Wood', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Sandeep S', 'Initials': 'SS', 'LastName': 'Kohli', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Shahin', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Twardowski', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': 'Neill K J', 'Initials': 'NKJ', 'LastName': 'Adhikari', 'Affiliation': ""From the Departments of Medicine (F. Lamontagne, M.-C.B., H.Q.M.) and Anesthesiology (F.D.), Université de Sherbrooke, the Department of Pharmacy (B.B.), Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke (F. Lamontagne, M.-H.M., J.M., F.D., E. Carbonneau), and Bishop's University (D.C.), Sherbrooke, QC, the Division of Orthopaedic Surgery, Department of Surgery (S.S.), the Department of Medicine (D.J.C., G.H.G., B.R., T.M., M.O.M., E.P.B.-C., S.S.K.), the Department of Health Research Methods, Evidence, and Impact (D.J.C., G.H.G., B.R., M.O.M., L.H., E.P.B.-C., F.C.), and the Population Health Research Institute (E.P.B.-C.), McMaster University, the Department of Critical Care, St. Joseph's Healthcare Hamilton (D.J.C.), the Intensive Care Unit, Juravinski Hospital (T.M.), and Respiratory Therapy, Hamilton Health Sciences (L.H.), Hamilton, ON, the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre (R. Pinto, N.M., N.K.J.A.), the Interdepartmental Division of Critical Care Medicine, University of Toronto (S.M., N.K.J.A.), and Sinai Health System (S.M.), Toronto, the Departments of Critical Care Medicine (D.K.H., D.M.M., M.H.), Public Health Sciences (A.G.D.),\xa0and Medicine (D.M.M.), Queen's University, and Kingston Health Sciences Centre (A.G.D., D.M.M.), Kingston, ON, the Department of Pharmacy, Ottawa Hospital (S.K.), Ottawa Hospital Research Institute (S.K., I.W., R. Porteous), and the Department of Surgery, University of Ottawa (A.J.E.S.), Ottawa, ON, the Massawippi Valley Foundation, Ayer's Cliff, QC (D.C.), the Department of Medicine, Université de Montréal (M.C.), the Centre Hospitalier de l'Université de Montréal (M.C., M.L., E. Charbonney), the Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal (E. Charbonney), and the Departments of Medicine and Critical Care, McGill University Health Centre (J.S.), Montreal, QC, the Department of Medicine (F. Lauzier) and the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care (F. Lauzier, A.F.T.), Université Laval, the Critical Care Medicine Service (F. Lauzier, A.F.T.), and the Research Center (F. Lauzier, A.F.T.), CHU de Québec-Université Laval, Quebec, QC, the Department of Critical Care Medicine, University of Alberta, Edmonton (O.G.R., D.J.K.), the Division of Intensive Care, Department of Medicine, CHU Dr. Georges L. Dumont, Moncton, NB (R.L.), the Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON (T.S.M.), the Division of Intensive Care Medicine, Island Health Authority, Victoria, BC (G.W.), and the Department of Medicine, Halton Healthcare, Oakville, ON (S.S.K.) - all in Canada; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital (R. Parke, S.P.M.), and the School of Nursing, University of Auckland (R. Parke),\xa0Auckland, the Medical Research Institute of New Zealand, Newtown (R. Parke, S.P.M., P.J.Y.), the Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y.),\xa0and the Department of Surgical Sciences, University of Otago, Dunedin (P.T.) - all in New Zealand; the Department of Critical Care Medicine, Apollo Hospitals, Chennai, and George Institute for Global Health, New Delhi - both in India (B.K.T.V.); the Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique-Hôpitaux de Paris [AP-HP]), and Fédération Hospitalo-Universitaire SEPSIS, Garches (D.A.), Institut National de la Santé et de la Recherche Médicale, University Paris-Saclay Campus UVSQ, Versailles (D.A.), and Service de Médecine Intensive Réanimation, AP-HP, Hôpitaux Universitaires Henri-Mondor, Groupe de Recherche Clinique CARMAS, and Institut Mondor de Recherche Biomédicale, Université Paris Est Créteil, Créteil (A.M.-D.) - all in France; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs - all in Riyadh, Saudi Arabia (Y.M.A.); and the Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia (R. Parke, S.P.M., P.J.Y.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2200644']
2426,35704219,"Effect of sodium fluoride varnish, Gluma, and Er,Cr:YSGG laser in dentin hypersensitivity treatment: a 6-month clinical trial.","Dentinal hypersensitivity (DH) is a common clinical condition usually associated with exposed dentinal surfaces. The aim of this study was to study the effect of sodium fluoride varnish, Gluma, and Er,Cr:YSGG laser, in the dentin hypersensitivity treatment. One hundred sixty-five teeth with dentin hypersensitivity in 55 patients were involved in this study. Teeth are divided into five groups based on the received treatment (n = 33): G group: Gluma; F group: sodium fluoride varnish (5%); L group: Er,Cr:YSGG laser (wavelength 2780 nm, frequency 20 Hz, power 0.25 W, energy density 44.3 J/cm 2 , and pulse width of 150 µs at distance of 1 mm for 30 s) which was followed by Er,Cr:YSGG laser; GL group: Gluma + laser; VL group: both sodium fluoride varnish and Gluma, which are common treatments for hypersensitivity, were selected as control groups. The treatment was performed in one session, and the sensitivity to air spray conditioning was recorded after the treatment, at 15 min, 1 week, 1 month, and 6 months as the VAS. Statistical analysis was performed using SPSS Ver. 21 software. One-way ANOVA was used to compare the VAS between all treatment groups at each time-point. One-way repeated measurements ANOVA (RM-ANOVA) and two-way-repeated measurements ANOVA (RM-ANOVA) were used to compare the hypersensitivity of each group and sensitivity of all treatment groups, respectively. Tukey post hoc test was used to compare the groups pairwise. The hypersensitivity between different groups at before and 15 min after the treatment was not significantly different (P = 0.063). The hypersensitivity of all studied groups was decreased after the treatment. The Er,Cr:YSGG laser, alone or in combination with Gluma, in 1 week, 1 month, and 6 month follow-ups, had significantly reduced the hypersensitivity instead of sodium fluoride varnish. All treatments significantly reduced the dentin hypersensitivity up to 6 months. Er,Cr:YSGG laser alone or in combination with Gluma was more effective than sodium fluoride varnish; however, it was not significantly different from other treatments. In a 6-month follow-up of dentine hypersensitivity treatment, Gluma had a significantly higher effect than sodium fluoride. Trial registration: IRCT20190422043343N1. Registered 19 July 2019.",2022,The hypersensitivity between different groups at before and 15 min after the treatment was not significantly different (P = 0.063).,"['dentin hypersensitivity treatment', 'One hundred sixty-five teeth with dentin hypersensitivity in 55 patients']","['sodium fluoride varnish', 'sodium fluoride varnish (5%); L group', 'Er,Cr:YSGG laser (wavelength 2780', 'sodium fluoride varnish and Gluma', 'sodium fluoride', 'sodium fluoride varnish, Gluma, and Er,Cr:YSGG laser']","['dentin hypersensitivity', 'sensitivity to air spray conditioning', 'Dentinal hypersensitivity (DH', 'hypersensitivity']","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0061452', 'cui_str': 'Gluma'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",55.0,0.00883412,The hypersensitivity between different groups at before and 15 min after the treatment was not significantly different (P = 0.063).,"[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Forouzande', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Arak University of Medical Sciences, Arak, Iran. mahsaforouzande@gmail.com.'}, {'ForeName': 'Loghman', 'Initials': 'L', 'LastName': 'Rezaei-Soufi', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Yarmohammadi', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mastooreh', 'Initials': 'M', 'LastName': 'Ganje-Khosravi', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Fekrazad', 'Affiliation': 'Department of Periodontology, Laser Research Center in Medical Sciences, School of Dentistry, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farhadian', 'Affiliation': 'Department of Biostatistics, School of Public Health and Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Farmany', 'Affiliation': 'Dental Research Center, School of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran. a.farmany@usa.com.'}]",Lasers in medical science,['10.1007/s10103-022-03583-3']
2427,32031973,Promoting drug abuse preventive behaviors in adolescent students based on the health belief model.,"BACKGROUND


Nowadays, drug abuse is one of the most important health problems that can affect the quality of life of people in mental, psychological, physical, and social dimensions. Theory-based education can help the adolescents to promote their drug abuse preventive behaviors.
OBJECTIVES


The aim of this study was to determine the effectiveness of education based on the health belief model (HBM) on drug abuse preventive behaviors in adolescent students.
METHODS


This study was an interventional quasi-experimental study with a pre-test/post-test design conducted in two high schools in the southeast of Iran. A two-step cluster sampling method was used and 120 students were randomly selected and categorized into the control (n = 60) and intervention (n = 60) groups. The intervention group participated in an education program based on the HBM in four 75-min sessions. Data were collected using demographic and drug abuse preventive behavior questionnaires based on the HBM.
RESULTS


In the pre-test stage, the mean scores of drug abuse preventive behaviors and its dimensions were not significantly different between the intervention and control groups (t = -2.597 p = 0.641). In the post-test stage, the mean scores of the intervention and control groups were significantly different; the drug abuse preventive behaviors and its dimensions improved in the intervention group (t = 14.57, p < 0.001).
CONCLUSION


The findings showed that education based on the HBM had a significant effect on drug abuse preventive behaviors and its dimensions. Therefore, educational packages based on the HBM are recommended to improve these behaviors in adolescents.",2020,"In the post-test stage, the mean scores of the intervention and control groups were significantly different; the drug abuse preventive behaviors and its dimensions improved in the intervention group (t = 14.57, p < 0.001).","['120 students were randomly selected and categorized into the control (n = 60) and intervention (n = 60) groups', 'two high schools in the southeast of Iran', 'adolescent students']","['education program based on the HBM', 'health belief model (HBM']","['drug abuse preventive behaviors', 'mean scores of drug abuse preventive behaviors and its dimensions', 'drug abuse preventive behaviors and its dimensions']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}]","[{'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}]",120.0,0.0145743,"In the post-test stage, the mean scores of the intervention and control groups were significantly different; the drug abuse preventive behaviors and its dimensions improved in the intervention group (t = 14.57, p < 0.001).","[{'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Fadaei', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Miri', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Goojani', 'Affiliation': 'MSc of Epidemiology, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0170']
2428,31945338,MAVRIC: a multicentre randomized controlled trial of transabdominal vs transvaginal cervical cerclage.,,2020,,[],['transabdominal versus transvaginal cervical cerclage'],[],[],"[{'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C3853999', 'cui_str': 'Cervical cerclage (physical object)'}]",[],,0.264374,,"[{'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Burger', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands. Electronic address: n.burger@amsterdamumc.nl.'}, {'ForeName': 'Jon I', 'Initials': 'JI', 'LastName': 'Einarsson', 'Affiliation': ""Department of Obstetrics and Gynecology, Brigham and Women's Hospital/Harvard Medical School, 75 Francis Street ASB1-3, Boston, MA.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'De Leeuw', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Huirne', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.01.006']
2429,31001692,Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia.,"PURPOSE


We designed a novel, manualized intervention called Emotion And Symptom-focused Engagement (EASE) for acute leukemia (AL) and report here on a phase II randomized controlled trial (RCT) to assess its feasibility and preliminary efficacy.
METHODS


Patients were recruited within 1 month of hospital admission and randomized to EASE plus usual care (UC) or UC alone. EASE includes (1) EASE-psy, a tailored psychotherapy delivered over 8 weeks, and (2) EASE-phys, weekly physical symptom screening over 8 weeks to trigger early palliative care. The primary outcome was traumatic stress symptoms; secondary outcomes included physical symptom burden and quality of life. Assessments were conducted at baseline and at 4, 8, and 12 weeks. Between-group differences were evaluated using multilevel modeling.
RESULTS


Forty-two patients were randomized to EASE (n = 22) or UC (n = 20), with 76% retention at 12 weeks. Predefined feasibility outcomes were met: 86% (19/22) of EASE participants completed ≥ 50% of EASE-psy sessions (goal ≥ 64%); 100% received Edmonton Symptom Assessment System (ESAS, modified for AL) screenings, 64% (14/22) of whom completed ≥ 50% of planned screenings (goal ≥50%); and 100% with scores ≥ 4/10 on any physical ESAS-AL item had ≥ 1 meeting with the EASE-phys team (goal 100%). Significant treatment-group differences favoring EASE were observed in traumatic stress symptoms at 4 and 12 weeks, and pain intensity and interference at 12 weeks (all p < .05).
CONCLUSIONS


EASE is feasible in patients newly diagnosed with AL and shows promise of effectiveness. These results warrant a larger RCT to provide evidence for its more routine use as a standard of care.",2020,"Significant treatment-group differences favoring EASE were observed in traumatic stress symptoms at 4 and 12 weeks, and pain intensity and interference at 12 weeks (all p < .05).
","['patients with acute leukemia', 'patients newly diagnosed with AL', 'acute leukemia (AL', ' modified for AL) screenings, 64% (14/22) of whom completed ≥\u200950% of planned screenings (goal ≥50%); and 100% with scores ≥\u20094/10 on any physical ESAS-AL item', 'Patients were recruited within 1\xa0month of hospital admission and randomized to', 'Forty-two patients']","['EASE', 'Edmonton Symptom Assessment System (ESAS', 'manualized intervention called Emotion And Symptom-focused Engagement (EASE', 'UC', 'EASE plus usual care (UC) or UC alone', 'integrated psychological and palliative care intervention']","['Emotion And Symptom-focused Engagement (EASE', 'traumatic stress symptoms', 'pain intensity and interference', 'physical symptom burden and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}]",42.0,0.0972998,"Significant treatment-group differences favoring EASE were observed in traumatic stress symptoms at 4 and 12 weeks, and pain intensity and interference at 12 weeks (all p < .05).
","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Rodin', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada. gary.rodin@uhn.ca.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Malfitano', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rydall', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Schimmer', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, 7th Floor, 610 University Avenue, Toronto, Ontario, M5G 2M9, Canada.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Marmar', 'Affiliation': 'Department of Psychiatry, New York University Langone Medical Center, 550 First Avenue, New York, NY, 10016, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mah', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lo', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.'}, {'ForeName': 'Rinat', 'Initials': 'R', 'LastName': 'Nissim', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04723-2']
2430,31978434,Safety and efficacy of sildenafil citrate to reduce operative birth for intrapartum fetal compromise at term: a phase 2 randomized controlled trial.,"BACKGROUND AND OBJECTIVE


Sildenafil citrate is a vasodilator used in erectile dysfunction and pulmonary hypertension. We tested whether it reduces emergency operative births for fetal compromise and improves fetal or uteroplacental perfusion in labor in a phase 2 double-blind randomized controlled trial.
STUDY DESIGN


Women at term in early labor or undergoing scheduled induction of labor at Mater Mother's Hospital, Brisbane, Australia, were randomly allocated 50 mg of sildenafil citrate orally 8 hourly up to 150 mg or placebo. Intrapartum fetal monitoring followed Royal Australian and New Zealand College of Obstetricians and Gynaecologists guidelines. Primary outcomes were (1) emergency operative birth (by cesarean delivery or instrumental vaginal birth) for intrapartum fetal compromise and (2) mean indices of fetal and uteroplacental perfusion using Doppler ultrasound. Analysis was by intention-to-treat.
TRIAL REGISTRATION NUMBER


ANZCTRN12615000319572 RESULTS: Between September 2015 and January 2019, 300 women were randomized equally to sildenafil citrate or placebo. Sildenafil citrate reduced the risk of emergency operative birth by 51% (18% vs 36.7%; relative risk, 0.49, 95% confidence interval, 0.33-0.73, P=.0004, number needed to treat = 5 [3-11]). There was no difference in indices of fetal and uteroplacental perfusion, but these were ascertained in only 71 women. Sildenafil citrate reduced the risk of meconium-stained liquor or pathologic fetal heart rate patterns by 43% (25.3% vs 44.7%; relative risk, 0.57, 95% confidence interval, 0.41-0.79, P=.0005), but its effects on fetal scalp sampling rates (2.0% vs 6.7%; relative risk, 0.30, 95% confidence interval, 0.08-1.07, P=.06) and adverse neonatal outcome (20.7% vs 21.3%; relative risk, 0.97, 95% confidence interval, 0.62-1.50, P=.89) were inconclusive. Only 3.6% of maternal levels of sildenafil citrate or its metabolite were detected in cord blood. No differences in maternal adverse events were seen.
CONCLUSION


Sildenafil citrate reduced operative birth for intrapartum fetal compromise, but much larger phase 3 trials of its effects on mother and child are needed before it can be routinely recommended.",2020,"Sildenafil citrate reduced the risk of emergency operative birth by 51% (18% vs. 36.7%; RR 0.49, 95% CI 0.33-0.73, p=0.0004, number needed to treat = 5 (3-11)).","[""Women at term in early labor or undergoing scheduled induction of labor at Mater Mother's Hospital, Brisbane, Australia"", 'Between September 2015 and January 2019, 300 women']","['sildenafil citrate', 'sildenafil citrate or placebo', 'placebo', 'Sildenafil citrate', 'Intrapartum fetal monitoring followed Royal Australian']","['maternal adverse events', 'operative birth', 'indices of fetal and utero-placental perfusion', 'emergency operative birth (by cesarean section or instrumental vaginal birth) for intrapartum fetal compromise and (ii) mean indices of fetal and utero-placental perfusion using Doppler ultrasound', 'risk of emergency operative birth', 'adverse neonatal outcome', 'fetal or utero-placental perfusion', 'Safety and efficacy', 'cord blood', 'fetal scalp sampling rates', 'risk of meconium stained liquor or pathological fetal heart rate patterns']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0015945', 'cui_str': 'Fetal Monitoring'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0426209', 'cui_str': 'Amniotic fluid -meconium stain (finding)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0018811', 'cui_str': 'Heart Rate, Fetal'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",300.0,0.668127,"Sildenafil citrate reduced the risk of emergency operative birth by 51% (18% vs. 36.7%; RR 0.49, 95% CI 0.33-0.73, p=0.0004, number needed to treat = 5 (3-11)).","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Mater Research Institute, The University of Queensland, Queensland, Australia; Faculty of Medicine, The University of Queensland, Queensland, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Dunn', 'Affiliation': 'Mater Research Institute, The University of Queensland, Queensland, Australia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tarnow-Mordi', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Flatley', 'Affiliation': 'Mater Research Institute, The University of Queensland, Queensland, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Flenady', 'Affiliation': 'Mater Research Institute, The University of Queensland, Queensland, Australia.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mater Research Institute, The University of Queensland, Queensland, Australia; Faculty of Medicine, The University of Queensland, Queensland, Australia. Electronic address: sailesh.kumar@mater.uq.edu.au.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.01.025']